,pmid,ti,ab,year,punchline_text,population,interventions,outcomes,population_mesh,interventions_mesh,outcomes_mesh,num_randomized,prob_low_rob,punchline_text,authors,journal,dois 0,32343001,Randomised clinical trial: the effectiveness of Gaviscon Advance vs non-alginate antacid in suppression of acid pocket and post-prandial reflux in obese individuals after late-night supper.,"BACKGROUND Late-night supper increases the risk of postprandial reflux from the acid pocket especially in obesity. An alginate-based, raft-forming medication may be useful for obese patients with GERD. AIMS To compare the efficacy of Gaviscon Advance (Reckitt Benckiser, UK) and a non-alginate antacid in post-supper suppression of the acid pocket and post-prandial reflux among obese participants. METHODS Participants underwent 48 h wireless and probe-based pH-metry recording of the acid pocket and lower oesophagus, respectively, and were randomised to single post-supper (10 pm) dose of either Gaviscon Advance or a non-alginate antacid on the second night. Primary outcomes were suppression of median pH of acid pocket and lower oesophagus, measured every 10-minutes post-supper for 1 h. Secondary outcomes were suppression of % time pH < 4 at lower oesophagus and improvement in frequency and visual analogue score (VAS) of regurgitation. RESULTS Of the 81 screened participants, 55 were excluded and 26 (mean age 33.5 years, males 77.8% and BMI 32.8 kg/m 2 ) were randomised to Gaviscon Advance (n = 13) or antacid (n = 13). Median pH of the acid pocket but not the lower oesophagus was suppressed with Gaviscon Advance vs antacid (all P < 0.04) Gaviscon Advance but not antacid significantly reduced in % time pH < 4, symptom frequency and VAS on day 2 vs day 1 (all P < 0.05). CONCLUSIONS Among obese individuals, Gaviscon Advance was superior to a non-alginate antacid in post-supper suppression of the acid pocket. (Clinical trial registration unique identifier: NCT03516188).",2020,"Among obese individuals, Gaviscon Advance is was superior to a non-alginate antacid in post-supper suppression of the acid pocket.","['Participants underwent 48\xa0h wireless and probe-based pH-metry recording of the acid pocket and lower oesophagus, respectively', 'Of the 81 screened participants, 55 were excluded and 26 (mean age 33.5\xa0years, males 77.8% and BMI 32.8\xa0kg/m 2 ', 'obese individuals after late-night supper', 'obese participants', 'obese patients with GERD']","['Gaviscon Advance (Reckitt Benckiser, UK) and a non-alginate antacid', 'antacid', 'Gaviscon Advance', 'Gaviscon Advance vs antacid', 'Gaviscon Advance vs non-alginate antacid', 'Gaviscon Advance or a non-alginate antacid']","['suppression of % time pH', 'Median pH of the acid pocket', 'symptom frequency and VAS', 'frequency and visual analogue score (VAS) of regurgitation', 'suppression of median pH of acid pocket and lower oesophagus']","[{'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0001128', 'cui_str': 'Acid'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0014876', 'cui_str': 'Esophageal structure'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C4048877', 'cui_str': 'Supper'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0017168', 'cui_str': 'Gastroesophageal reflux disease'}]","[{'cui': 'C0061146', 'cui_str': 'Gaviscon'}, {'cui': 'C0002040', 'cui_str': 'Alginates'}, {'cui': 'C0003138', 'cui_str': 'Antacid'}]","[{'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001128', 'cui_str': 'Acid'}, {'cui': 'C0436350', 'cui_str': 'Symptom frequency'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0232605', 'cui_str': 'Regurgitates after swallowing'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0014876', 'cui_str': 'Esophageal structure'}]",81.0,0.0540182,"Among obese individuals, Gaviscon Advance is was superior to a non-alginate antacid in post-supper suppression of the acid pocket.","[{'ForeName': 'Mohd Adli', 'Initials': 'MA', 'LastName': 'Deraman', 'Affiliation': 'School of Medical Sciences, Universiti Sains Malaysia, Kota Bahru, Malaysia.'}, {'ForeName': 'Muhammad Ilham', 'Initials': 'MI', 'LastName': 'Abdul Hafidz', 'Affiliation': 'Faculty of Medicine, Universiti Teknologi MARA, Sungai Buloh, Malaysia.'}, {'ForeName': 'Rona Marie', 'Initials': 'RM', 'LastName': 'Lawenko', 'Affiliation': 'De La Salle Health Sciences Institute, Dasmarinas, Philippines.'}, {'ForeName': 'Zheng Feei', 'Initials': 'ZF', 'LastName': 'Ma', 'Affiliation': 'School of Medical Sciences, Universiti Sains Malaysia, Kota Bahru, Malaysia.'}, {'ForeName': 'Mung Seong', 'Initials': 'MS', 'LastName': 'Wong', 'Affiliation': 'School of Medical Sciences, Universiti Sains Malaysia, Kota Bahru, Malaysia.'}, {'ForeName': 'Cathal', 'Initials': 'C', 'LastName': 'Coyle', 'Affiliation': 'Reckitt Benckiser, Slough, UK.'}, {'ForeName': 'Yeong Yeh', 'Initials': 'YY', 'LastName': 'Lee', 'Affiliation': 'School of Medical Sciences, Universiti Sains Malaysia, Kota Bahru, Malaysia.'}]",Alimentary pharmacology & therapeutics,['10.1111/apt.15746'] 1,32343081,Muscular morphological adaptations of two whole-body high intensity interval training configurations.,"BACKGROUND High-intensity intermittent training (HIIT) has increased in popularity due to being time-efficient mode of exercise. Previous HIIT studies have mainly focused on percentage of fat loss, fat mass loss, and weight loss. However, enhancing muscle protein synthesis induced by HIIT that results in muscular morphological adaptations is a potential benefit of HIIT. This study compared the effects of two HIIT protocols on muscular morphological adaptations. METHODS Thirty-four recreationally active participants were randomly assigned to 10-5-HIIT and 20-10-HIIT to complete 6 sets of 6 intervals. The 10-5-HIIT and 20-10-HIIT protocols were performed with 10s:5s and 20s:10s exercise-to-rest ratios and provided with 1- and 2-min recovery periods between sets, respectively. Muscle cross-sectional area (mCSA) and echo intensity (EI) of the rectus femoris (RF) and vastus lateralis (VL) were assessed via B-mode ultrasonography before and after intervention. Two-way mixed factorial ANOVAs were used for analyses. RESULTS The 10-5-HIIT and 20-10-HIIT groups significantly (P<0.05) increased RF mCSA (change (Δ)=0.4±0.8 cm2, 8.0%; Δ=0.5±0.8 cm2, 5.5%) and VL mCSA (Δ=1.2±1.6 cm2, 9.0%; Δ=2.20±1.4 cm2, 10.4%), respectively. No significant (P>0.05) change was observed for the EI of the RF and VL. CONCLUSIONS Whole-body HIIT can be a time-efficient exercise modality to elicit muscular morphological adaptations in the RF and VL muscles. The 10-5-HIIT protocol induced benefits comparable to those of the 20-10-HIIT, while it reduced the total exercise time by 50%.",2020,"The 10-5-HIIT and 20-10-HIIT groups significantly (p < 0.05) increased RF mCSA (change (Δ) = 0.4 ± 0.8 cm2, 8.0%; Δ = 0.5 ± 0.8 cm2, 5.5%) and VL mCSA (Δ = 1.2 ± 1.6 cm2, 9.0%; Δ = 2.20 ± 1.4 cm2, 10.4%), respectively.",['Thirty-four recreationally active participants'],"['two whole-body high intensity interval training (HIIT) configurations', 'High-intensity intermittent training (HIIT']","['Muscle cross-sectional area (mCSA) and echo intensity (EI) of the rectus femoris (RF) and vastus lateralis (VL', 'fat loss, fat mass loss, and weight loss', 'RF mCSA', 'total exercise time']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0205177', 'cui_str': 'Active'}]","[{'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0449830', 'cui_str': 'With configuration'}]","[{'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0010362', 'cui_str': 'Cross Sectional Analysis'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0013520', 'cui_str': 'Doppler Echocardiography'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0584894', 'cui_str': 'Rectus femoris muscle structure'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0429931', 'cui_str': 'Total exercise time'}]",34.0,0.0221676,"The 10-5-HIIT and 20-10-HIIT groups significantly (p < 0.05) increased RF mCSA (change (Δ) = 0.4 ± 0.8 cm2, 8.0%; Δ = 0.5 ± 0.8 cm2, 5.5%) and VL mCSA (Δ = 1.2 ± 1.6 cm2, 9.0%; Δ = 2.20 ± 1.4 cm2, 10.4%), respectively.","[{'ForeName': 'Masoud', 'Initials': 'M', 'LastName': 'Moghaddam', 'Affiliation': 'Oklahoma State University, Stillwater, OK, USA - masoud.moghaddam@okstate.edu.'}, {'ForeName': 'Carlos A', 'Initials': 'CA', 'LastName': 'Estrada', 'Affiliation': 'Aurora University, Aurora, IL, USA.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Baghurst', 'Affiliation': 'Florida State University, Tallahassee, FL, USA.'}, {'ForeName': 'Bert H', 'Initials': 'BH', 'LastName': 'Jacobson', 'Affiliation': 'Oklahoma State University, Stillwater, OK, USA.'}]",The Journal of sports medicine and physical fitness,['10.23736/S0022-4707.20.10526-7'] 2,32275872,Correction to Lancet Infect Dis 2020; published online March 30. https://doi.org/10.1016/S1473-3099(20)30150-X.,,2020,,[],['https://doi.org/10.1016/S1473-3099(20)30150-X'],[],[],[],[],,0.019819,,[],The Lancet. Infectious diseases,['10.1016/S1473-3099(20)30291-7'] 3,32366927,Effects of chronic type 5 phosphodiesterase inhibition on penile microvascular reactivity in hypertensive patients with erectile dysfunction: a randomized crossover placebo-controlled trial.,"This randomized crossover and placebo-controlled trial evaluated the effects of daily use of sildenafil citrate (SIL, 1-month 50 mg twice daily) on penile and systemic endothelial microvascular function in hypertensive patients presenting with erectile dysfunction. The effects of SIL on arterial pressure were evaluated using ambulatory blood pressure monitoring (ABPM). Fifty patients diagnosed with primary arterial hypertension and erectile dysfunction (aged 57.4 ± 5.6 years), recruited in a tertiary public hospital, were treated with SIL (50 mg twice daily) or placebo (PLA) for two 30-day periods with a 30-day washout between them. Laser speckle contrast imaging coupled with acetylcholine skin iontophoresis was used to evaluate penile and systemic (forearm) cutaneous microvascular reactivity. SIL treatment increased penile basal microvascular flow (P = 0.002) and maximal endothelial-dependent peak response to skin iontophoresis of acetylcholine (ACh, P = 0.006). The area under the curve of microvascular vasodilation induced by ACh was also significantly increased (P = 0.02). Lastly, SIL treatment did not modify systemic microvascular reactivity. Twenty-four-hour ABPM (P = 0.0002) and daytime (P = 0.002) and nighttime (P = 0.001) mean diastolic blood pressure values were significantly reduced after SIL treatment. The scores of the Simplified International Index of Erectile Function (P < 0.0001) and the number of patients with positive responses to Sexual Encounter Profile question 3 (P < 0.0001) also increased after SIL treatment. Penile endothelium-dependent microvascular reactivity improved after continuous use of sildenafil in hypertensive patients with erectile dysfunction; the treatment also reduced blood pressure, suggesting that, in addition to improving erectile function, daily use of sildenafil could improve blood pressure control.",2020,"SIL treatment increased penile basal microvascular flow (P = 0.002) and maximal endothelial-dependent peak response to skin iontophoresis of acetylcholine (ACh, P = 0.006).","['hypertensive patients with erectile dysfunction', 'hypertensive patients presenting with erectile dysfunction', 'Fifty patients diagnosed with primary arterial hypertension and erectile dysfunction (aged 57.4\u2009±\u20095.6 years), recruited in a tertiary public hospital']","['SIL', 'Laser speckle contrast imaging coupled with acetylcholine skin iontophoresis', 'sildenafil', 'chronic type 5 phosphodiesterase inhibition', 'sildenafil citrate (SIL, 1-month 50\u2009mg twice daily', 'placebo (PLA', 'placebo']","['penile and systemic endothelial microvascular function', 'penile microvascular reactivity', 'ambulatory blood pressure monitoring (ABPM', 'blood pressure control', 'systemic microvascular reactivity', 'area under the curve of microvascular vasodilation', 'daytime', 'mean diastolic blood pressure values', 'microvascular reactivity', 'scores of the Simplified International Index of Erectile Function', 'penile basal microvascular flow', 'penile and systemic (forearm) cutaneous microvascular reactivity', 'arterial pressure']","[{'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0242350', 'cui_str': 'Impotence'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C4517794', 'cui_str': '5.6'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0020022', 'cui_str': 'Public Hospitals'}]","[{'cui': 'C0257766', 'cui_str': 'SILV protein, human'}, {'cui': 'C3854375', 'cui_str': 'Laser speckle contrast imaging'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0001041', 'cui_str': 'Acetylcholine'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0022024', 'cui_str': 'Iontophoresis procedure'}, {'cui': 'C0529793', 'cui_str': 'sildenafil'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0457499', 'cui_str': 'Type 5'}, {'cui': 'C0031640', 'cui_str': 'Phosphoric diester hydrolase'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0724693', 'cui_str': 'Sildenafil citrate'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0030851', 'cui_str': 'Penile structure'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0443258', 'cui_str': 'Microvascular'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0242876', 'cui_str': 'Ambulatory Blood Pressure Monitoring'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0042401', 'cui_str': 'Vasodilatation'}, {'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C2960541', 'cui_str': 'International index of erectile function'}, {'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C1522447', 'cui_str': 'Cutaneous route'}, {'cui': 'C0232108', 'cui_str': 'Arterial pulse pressure'}]",50.0,0.0960623,"SIL treatment increased penile basal microvascular flow (P = 0.002) and maximal endothelial-dependent peak response to skin iontophoresis of acetylcholine (ACh, P = 0.006).","[{'ForeName': 'Valéria', 'Initials': 'V', 'LastName': 'Verri', 'Affiliation': 'National Institute of Cardiology, Ministry of Health, Rio de Janeiro, Brazil.'}, {'ForeName': 'Alessandro R', 'Initials': 'AR', 'LastName': 'Nascimento', 'Affiliation': 'National Institute of Cardiology, Ministry of Health, Rio de Janeiro, Brazil.'}, {'ForeName': 'Andrea A', 'Initials': 'AA', 'LastName': 'Brandao', 'Affiliation': 'State University of Rio de Janeiro, Rio de Janeiro, Brazil.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Tibirica', 'Affiliation': 'National Institute of Cardiology, Ministry of Health, Rio de Janeiro, Brazil. etibi@uol.com.br.'}]",Journal of human hypertension,['10.1038/s41371-020-0343-3'] 4,32340155,Impact of an Individualized Cognitive Training Intervention in Preschoolers from Poor Homes.,"Over the last few decades, different interventions were shown to be effective in changing cognitive performance in preschoolers from poor homes undertaking tasks with executive demands. However, this evidence also showed that not all children included in the intervention groups equally increased their performance levels, which could be related to individual and contextual variability. The present study aimed to explore the impact of a computerized cognitive training intervention with lab-based tasks in preschoolers from Unsatisfied Basic Needs (UBN) homes under the consideration of their baseline performance. In the context of a randomized controlled trial design, different interventions were administered to children according to their baseline performance in a variety of cognitive tasks (i.e., executive attention, inhibitory control, working memory, and planning demands). The results showed different patterns of impact on performance depending on the experimental group, supporting the importance of considering individual and contextual differences in the design of interventions aimed at optimizing executive functions in poverty-impacted sample populations in early stages of development.",2020,"Over the last few decades, different interventions were shown to be effective in changing cognitive performance in preschoolers from poor homes undertaking tasks with executive demands.","['preschoolers from Unsatisfied Basic Needs (UBN) homes under the consideration of their baseline performance', 'Preschoolers from Poor Homes']","['computerized cognitive training intervention with lab-based tasks', 'Individualized Cognitive Training Intervention']",['performance levels'],"[{'cui': 'C0008100', 'cui_str': 'Preschool child'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}]","[{'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.0586055,"Over the last few decades, different interventions were shown to be effective in changing cognitive performance in preschoolers from poor homes undertaking tasks with executive demands.","[{'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Giovannetti', 'Affiliation': 'Unidad de Neurobiología Aplicada (UNA), CEMIC-CONICET, Buenos Aires C1431FWO, Argentina.'}, {'ForeName': 'Marcos Luis', 'Initials': 'ML', 'LastName': 'Pietto', 'Affiliation': 'Unidad de Neurobiología Aplicada (UNA), CEMIC-CONICET, Buenos Aires C1431FWO, Argentina.'}, {'ForeName': 'María Soledad', 'Initials': 'MS', 'LastName': 'Segretín', 'Affiliation': 'Unidad de Neurobiología Aplicada (UNA), CEMIC-CONICET, Buenos Aires C1431FWO, Argentina.'}, {'ForeName': 'Sebastián Javier', 'Initials': 'SJ', 'LastName': 'Lipina', 'Affiliation': 'Unidad de Neurobiología Aplicada (UNA), CEMIC-CONICET, Buenos Aires C1431FWO, Argentina.'}]",International journal of environmental research and public health,['10.3390/ijerph17082912'] 5,32340219,The TTCYB Study Protocol: A Tailored Print Message Intervention to Improve Cardiovascular Patients' Lifestyles.,"This article describes the development of the ""Time to Change Your Behavior"" (TTCYB) study protocol, a theory-based, tailored print message intervention to improve compliance with the self-care regimen in patients with cardiovascular diseases. A design with a baseline measurement and two follow-ups at six and 12 months will be applied. At baseline and the six-month follow-up, patients will complete self-report questionnaires evaluating lifestyle habits and socio-demographic and psychological variables; at the 12-month follow-up, patients will answer a telephone interview assessing lifestyle habits. After the baseline measurement, patients will be randomized into one of three groups: (1) the tailored group, which will receive tailored health brochures; (2) the ""non-tailored"" group, which will receive non-tailored health brochures; or (3) the usual care group, which will receive no print information materials. The effectiveness of the intervention will be assessed through patients' judgments of the brochures and changes in lifestyle. The role of socio-demographic and psychological variables as potential moderators of the materials' effectiveness will be explored. If the TTCYB is efficacious, it will have implications for the design and implementation of tailored communication programs. Concepts from this study can be potentially extended to primary prevention among high-risk groups.",2020,"If the TTCYB is efficacious, it will have implications for the design and implementation of tailored communication programs.","['patients with cardiovascular diseases', ""Cardiovascular Patients' Lifestyles""]","['tailored health brochures; (2) the ""non-tailored"" group, which will receive non-tailored health brochures; or (3) the usual care group, which will receive no print information materials', 'Tailored Print Message Intervention', 'telephone interview assessing lifestyle habits']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0023676', 'cui_str': 'Life style'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0033161', 'cui_str': 'Printing'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0021823', 'cui_str': 'Interviews, Telephone'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0018464', 'cui_str': 'Habits'}]",[],,0.0176912,"If the TTCYB is efficacious, it will have implications for the design and implementation of tailored communication programs.","[{'ForeName': 'Marco', 'Initials': 'M', 'LastName': ""D'Addario"", 'Affiliation': 'Department of Psychology, University of Milano-Bicocca, 20126 Milan, Italy.'}, {'ForeName': 'Erika Rosa', 'Initials': 'ER', 'LastName': 'Cappelletti', 'Affiliation': 'Health Promotion Division, Agenzia Tutela Salute Milano, 20129 Milan, Italy.'}, {'ForeName': 'Marcello', 'Initials': 'M', 'LastName': 'Sarini', 'Affiliation': 'Department of Psychology, University of Milano-Bicocca, 20126 Milan, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Greco', 'Affiliation': 'Department of Human and Social Sciences, University of Bergamo, 24129 Bergamo, Italy.'}, {'ForeName': 'Patrizia', 'Initials': 'P', 'LastName': 'Steca', 'Affiliation': 'Department of Psychology, University of Milano-Bicocca, 20126 Milan, Italy.'}]",International journal of environmental research and public health,['10.3390/ijerph17082919'] 6,32340343,"Combined Black Rice Germ, Bran Supplement and Exercise Intervention Modulate Aging Biomarkers and Improve Physical Performance and Lower-Body Muscle Strength Parameters in Aging Population.","Aging is a time-dependent functional decline in muscle mass and strength, which is reflected in poor physical performances, hormonal imbalance, and development of chronic low-grade inflammation. This study aimed to assess the effectiveness of black rice germ, bran supplement, and exercise program either alone or in combination for 24 weeks on the aging biomarkers (C-reactive protein, Interleukin-6, Insulin-like growth factor-1, and CD4:CD8 T cell ratio) physical performance, muscle strength parameters (walking speed, sit-to-stand time, grip strength) among Thai aging population. A total of 120 healthy volunteers aged 65-74 years were assigned to the exercise group (EX), black rice germ, and bran supplement (BR) group or the combination of BR and EX group (BR + EX). Over the course of the 24-week intervention, compared with baseline data (T0), the combined BR + EX intervention significantly decreased the inflammatory biomarkers (C-reactive protein and interleukin-6 levels, both p < 0.05 vs. T0) and significantly increased the insulin-like growth factor-1 levels ( p < 0.001 vs. T0). Significant improvement in physical performance and muscle strength were also observed in the combined BR + EX group (decrease in sit-to-stand time and gait speed over the 24-week intervention, both p < 0.05 vs. T0, and trend toward grip strength improvement at p = 0.088 vs. T0). Overall, our results indicated a synergistic effect towards the combined intervention with the sustainable improvement in physical performances, lower-body muscle strength, and the modulation of both inflammatory and endocrine biomarkers. This study could encourage older adults to change their lifestyles to improve healthy aging and longevity.",2020,"Significant improvement in physical performance and muscle strength were also observed in the combined BR + EX group (decrease in sit-to-stand time and gait speed over the 24-week intervention, both p < 0.05 vs. T0, and trend toward grip strength improvement at p = 0.088 vs. T0).","['Thai aging population', 'Aging Population', 'older adults', '120 healthy volunteers aged 65-74 years']","['exercise group (EX), black rice germ, and bran supplement (BR) group or the combination of BR and EX group (BR + EX', 'combined BR + EX', 'black rice germ, bran supplement, and exercise program either alone or in combination', 'Combined Black Rice Germ, Bran Supplement and Exercise Intervention', 'combined BR + EX intervention']","['aging biomarkers (C-reactive protein, Interleukin-6, Insulin-like growth factor-1, and CD4:CD8 T cell ratio) physical performance, muscle strength parameters (walking speed, sit-to-stand time, grip strength', 'sit-to-stand time and gait speed', 'insulin-like growth factor-1 levels', 'grip strength improvement', 'physical performance and muscle strength', 'physical performances, lower-body muscle strength, and the modulation of both inflammatory and endocrine biomarkers', 'inflammatory biomarkers (C-reactive protein and interleukin-6 levels']","[{'cui': 'C0039724', 'cui_str': 'Thai language'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C1276393', 'cui_str': 'Group exercise'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C3257691', 'cui_str': 'Rice germ preparation'}, {'cui': 'C0353942', 'cui_str': 'Bran'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0021665', 'cui_str': 'Somatomedin C'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0560801', 'cui_str': 'Does stand from sitting'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0429271', 'cui_str': 'Grip strength'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1268088', 'cui_str': 'Lower body structure'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0014136', 'cui_str': 'Structure of endocrine system'}]",120.0,0.0145485,"Significant improvement in physical performance and muscle strength were also observed in the combined BR + EX group (decrease in sit-to-stand time and gait speed over the 24-week intervention, both p < 0.05 vs. T0, and trend toward grip strength improvement at p = 0.088 vs. T0).","[{'ForeName': 'Mathuramat', 'Initials': 'M', 'LastName': 'Seesen', 'Affiliation': 'Department of Community Medicine, Faculty of Medicine, Chiang Mai University, Chiang Mai 50200, Thailand.'}, {'ForeName': 'Warathit', 'Initials': 'W', 'LastName': 'Semmarath', 'Affiliation': 'Department of Biochemistry, Faculty of Medicine, Chiang Mai University, Chiang Mai 50200, Thailand.'}, {'ForeName': 'Supachai', 'Initials': 'S', 'LastName': 'Yodkeeree', 'Affiliation': 'Department of Biochemistry, Faculty of Medicine, Chiang Mai University, Chiang Mai 50200, Thailand.'}, {'ForeName': 'Ratana', 'Initials': 'R', 'LastName': 'Sapbamrer', 'Affiliation': 'Department of Community Medicine, Faculty of Medicine, Chiang Mai University, Chiang Mai 50200, Thailand.'}, {'ForeName': 'Pisittawoot', 'Initials': 'P', 'LastName': 'Ayood', 'Affiliation': 'Department of Community Medicine, Faculty of Medicine, Chiang Mai University, Chiang Mai 50200, Thailand.'}, {'ForeName': 'Rungnapa', 'Initials': 'R', 'LastName': 'Malasao', 'Affiliation': 'Department of Community Medicine, Faculty of Medicine, Chiang Mai University, Chiang Mai 50200, Thailand.'}, {'ForeName': 'Krongporn', 'Initials': 'K', 'LastName': 'Ongprasert', 'Affiliation': 'Department of Community Medicine, Faculty of Medicine, Chiang Mai University, Chiang Mai 50200, Thailand.'}, {'ForeName': 'Jiraporn', 'Initials': 'J', 'LastName': 'Chittrakul', 'Affiliation': 'Department of Community Medicine, Faculty of Medicine, Chiang Mai University, Chiang Mai 50200, Thailand.'}, {'ForeName': 'Penprapa', 'Initials': 'P', 'LastName': 'Siviroj', 'Affiliation': 'Department of Community Medicine, Faculty of Medicine, Chiang Mai University, Chiang Mai 50200, Thailand.'}, {'ForeName': 'Pornngarm', 'Initials': 'P', 'LastName': 'Limtrakul Dejkriengkraikul', 'Affiliation': 'Department of Biochemistry, Faculty of Medicine, Chiang Mai University, Chiang Mai 50200, Thailand.'}]",International journal of environmental research and public health,['10.3390/ijerph17082931'] 7,32340417,[Clinical effectiveness of super pulsed carbon dioxide fractional laser debridement surgery in treating chronic wounds].,"Objective: To investigate the clinical effectiveness of super pulsed carbon dioxide fractional laser debridement surgery on the treatment of chronic wounds. Methods: From December 2018 to May 2019, 37 patients with chronic wounds who met the inclusion criteria were admitted to the Affiliated Hospital of Southwest Medical University for a prospective randomized controlled study. Using the random number table, the patients were divided into surgical debridement group (19 patients, 4 males and 15 females, aged (58±16) years, 25 wounds) and laser debridement group (18 patients, 9 males and 9 females, aged (58±10) years, 23 wounds). In patients of surgical debridement group, oedematous and aging granulation tissue was scraped from the wound by scalpel handle or curet, and the residual necrotic tissue was removed by sharp surgical instruments. In patients of laser debridement group, oedematous and aging granulation tissue and necrotic tissue was removed by super pulsed carbon dioxide fractional laser therapeutic machine, laser gasification debridement was performed repeatedly till fresh normal tissue layer observed. In patients of the two groups, according to the wound in the first 3 d after the first debridement, debridement dressing was performed twice at least as before, then wound debridement dressing was performed once every 1 to 4 days as before according to the wound conditions. The wound healing rates on 7, 14, 21, and 28 d after the first debridement were calculated. The positive rates of bacterial culture of wounds before and after the first debridement were calculated. The color and texture of the wound granulation tissue before the first debridement and on 7, 14, and 28 d after the first debridement were observed and scored. The pain scores before every debridement, during every debridement, and after every debridement dressing change were evaluated by visual analogue scale. The times of debridement dressing change were recorded. Data were statistically analyzed with two independent sample t test, analysis of variance for repeated measurement, Fisher's exact probability test, Mann-Whitney U test, and Bonferroni correction. Results: (1) On 7, 14, 21, and 28 d after the first debridement, the wound healing rates of patients in laser debridement group (29.5% (24.1%, 36.0%), 47.1% (42.7%, 62.4%), 71.4% (62.2%, 76.8%), and 88.6% (79.2%, 96.3%) were significantly higher than those of surgical debridement group (1.6% (1.0%, 12.8%), 12.7% (2.0%, 16.6%), 24.5% (8.9%, 45.5%), 43.9% (23.2%, 70.8%), Z =3.477, 3.553, 2.721, 2.193, P <0.05 or P <0.01). (2) Before the first debridement, the positive rates of bacterial culture of wounds in patients of laser debridement group and surgical debridement group were 92% (23/25) and 91% (21/23), respectively, which were similar ( P >0.05). After the first debridement, the positive rate of bacterial culture of wounds of patients in surgical debridement group was 64% (16/25), which was significantly higher than 13% (3/23) of laser debridement group ( P <0.01). (3) On 7, 14, and 28 d after the first debridement, the scores of color and texture of wound granulation tissue of patients in laser debridement group were significantly higher than those of surgical debridement group ( Z =3.420, 5.682, 6.142, 4.461, 5.337, 4.458, P <0.01). (4) The pain scores during every debridement and after every debridement dressing change in patients of laser debridement group were significantly lower than those of surgical debridement group ( t =2.847, 5.046, P <0.05 or P <0.01). (5) The time of debridement dressing change in laser debridement group was 8.0 (7.0, 10.0) times, which was significantly less than 10.0 (9.5, 12.5) times in surgical debridement group ( Z =2.261, P <0.05). Conclusions: Compared with traditional surgical debridement method, super pulsed carbon dioxide fractional laser debridement surgery is more effective in treating patients with chronic wounds. Laser debridement makes the wound healing more efficiently with reduced pain and better infection control; significantly reduces the number of dressing changes, and is especially suitable for the wound treatment in outpatients.",2020,"Laser debridement makes the wound healing more efficiently with reduced pain and better infection control; significantly reduces the number of dressing changes, and is especially suitable for the wound treatment in outpatients.","['37 patients with chronic wounds who met the inclusion criteria were admitted to the Affiliated Hospital of Southwest Medical University', 'patients with chronic wounds', '19 patients, 4 males and 15 females, aged (58±16) years, 25 wounds) and laser debridement group (18 patients, 9 males and 9 females, aged (58±10) years, 23 wounds']","['Laser debridement', 'surgical debridement group', 'traditional surgical debridement method, super pulsed carbon dioxide fractional laser debridement surgery', 'super pulsed carbon dioxide fractional laser debridement surgery']","['scores of color and texture of wound granulation tissue', 'pain scores', 'time of debridement dressing change', 'color and texture of the wound granulation tissue', 'visual analogue scale', 'oedematous and aging granulation tissue', 'wound healing rates', 'oedematous and aging granulation tissue and necrotic tissue', 'positive rates of bacterial culture of wounds', 'positive rate of bacterial culture of wounds']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0011079', 'cui_str': 'Debridement'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0011079', 'cui_str': 'Debridement'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0449582', 'cui_str': 'With texture'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0018180', 'cui_str': 'Granulation tissue'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0011079', 'cui_str': 'Debridement'}, {'cui': 'C0013119', 'cui_str': 'Medical dressing'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0013604', 'cui_str': 'Edema'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0027540', 'cui_str': 'Necrosis'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0430402', 'cui_str': 'Bacterial culture'}]",37.0,0.0183105,"Laser debridement makes the wound healing more efficiently with reduced pain and better infection control; significantly reduces the number of dressing changes, and is especially suitable for the wound treatment in outpatients.","[{'ForeName': 'B', 'Initials': 'B', 'LastName': 'Jiang', 'Affiliation': 'Department of Plastic Surgery and Burns, the Affiliated Hospital of Southwest Medical University, Luzhou 646000, China.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Tang', 'Affiliation': 'Department of Plastic Surgery and Burns, the Affiliated Hospital of Southwest Medical University, Luzhou 646000, China.'}, {'ForeName': 'D Y', 'Initials': 'DY', 'LastName': 'Zheng', 'Affiliation': 'Department of Plastic Surgery and Burns, the Affiliated Hospital of Southwest Medical University, Luzhou 646000, China.'}, {'ForeName': 'Y T', 'Initials': 'YT', 'LastName': 'Yang', 'Affiliation': 'Department of Plastic Surgery and Burns, the Affiliated Hospital of Southwest Medical University, Luzhou 646000, China.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Plastic Surgery and Burns, the Affiliated Hospital of Southwest Medical University, Luzhou 646000, China.'}, {'ForeName': 'R R', 'Initials': 'RR', 'LastName': 'Yang', 'Affiliation': 'Department of Plastic Surgery and Burns, the Affiliated Hospital of Southwest Medical University, Luzhou 646000, China.'}, {'ForeName': 'L G', 'Initials': 'LG', 'LastName': 'Liu', 'Affiliation': 'Department of Plastic Surgery and Burns, the Affiliated Hospital of Southwest Medical University, Luzhou 646000, China.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Yan', 'Affiliation': 'Department of Plastic Surgery and Burns, the Affiliated Hospital of Southwest Medical University, Luzhou 646000, China.'}]",Zhonghua shao shang za zhi = Zhonghua shaoshang zazhi = Chinese journal of burns,['10.3760/cma.j.cn501120-20190415-00186'] 8,32340838,The Impact of Extracorporeal Shock Wave Therapy and Dry Needling Combination on Pain and Functionality in the Patients Diagnosed with Plantar Fasciitis.,"This study aimed to evaluate the efficiency of extracorporeal shock wave therapy (ESWT) and dry needling (DN) combination on pain and functionality in plantar fasciitis. Forty patients who were clinically diagnosed with plantar fasciitis were included in the study. The patients were randomly divided into 2 groups. The ESWT-DN group was applied 3 sessions of ESWT to plantar fascia and DN to the trigger points in the gastrosoleus muscles. The ESWT group was applied only ESWT treatment to plantar fascia. We used visual analog scale (VAS) for pain and a pressure algometer for pressure pain threshold. The functionality of the patients was evaluated with Foot Function Index (FFI). Also, maximum painless standing time and maximum painless walking distance were recorded. All assessments were repeated twice; first, pretreatment and second 1 month after the treatment. In both groups, there were statistically significant improvements in VAS, pressure pain threshold, maximum painless standing time, maximum painless walking distance, and FFI's pain, disability, and activity limitation subscales scores (p ≤ .001). In intergroup comparison; it was showed that VAS scores, maximum painless standing time (p = .002), maximum painless walking distance (p ≤ .001), and FFI pain subscale scores (p = .034) were statistically superior in the ESWT-DN group. There was no statistically difference between the groups in pressure pain threshold (p = .132), FFI disability (p = .081), and FFI activity limitation subscale (p = .226) scores. ESWT and DN combination therapy in plantar fasciitis was seen to be superior in the pain scores. Further studies with larger patients' groups and longer term results of this combination are needed for a better comparison.",2020,"There was no statistically difference between the groups in pressure pain threshold (p = .132), FFI disability (p = .081), and FFI activity limitation subscale (p = .226) scores.","['Forty patients who were clinically diagnosed with plantar fasciitis', 'plantar fasciitis', 'Patients Diagnosed with Plantar Fasciitis']","['extracorporeal shock wave therapy (ESWT) and dry needling (DN) combination', 'ESWT and DN combination therapy', 'Extracorporeal Shock Wave Therapy and Dry Needling Combination']","['pain scores', 'maximum painless walking distance', 'Pain and Functionality', 'pressure pain threshold', 'visual analog scale (VAS) for pain', 'maximum painless standing time and maximum painless walking distance', 'FFI activity limitation subscale', 'FFI pain subscale scores', ""VAS, pressure pain threshold, maximum painless standing time, maximum painless walking distance, and FFI's pain, disability, and activity limitation subscales scores"", 'FFI disability', 'Foot Function Index (FFI', 'VAS scores, maximum painless standing time', 'pain and functionality']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0149756', 'cui_str': 'Plantar fasciitis'}]","[{'cui': 'C1737238', 'cui_str': 'Extracorporeal shock wave therapy'}, {'cui': 'C0394648', 'cui_str': 'Dry needle acupuncture'}, {'cui': 'C0011682', 'cui_str': 'Desiccation - action'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0009429', 'cui_str': 'Combination therapy'}]","[{'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0234226', 'cui_str': 'Painless'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C4706287', 'cui_str': 'Foot Function Index'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0459443', 'cui_str': 'Subscale score'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}]",40.0,0.0179388,"There was no statistically difference between the groups in pressure pain threshold (p = .132), FFI disability (p = .081), and FFI activity limitation subscale (p = .226) scores.","[{'ForeName': 'Fatih', 'Initials': 'F', 'LastName': 'Bagcier', 'Affiliation': 'Assistant Professor, Department of Physical Medicine and Rehabilitation, Faculty of Medicine, Biruni University, İstanbul, Turkey. Electronic address: bagcier_42@hotmail.com.'}, {'ForeName': 'Nurdan', 'Initials': 'N', 'LastName': 'Yilmaz', 'Affiliation': 'Assistant Professor, Department of Physical Medicine and Rehabilitation, Medical Faculty, Gaziosmanpaşa University, Tokat, Turkey.'}]",The Journal of foot and ankle surgery : official publication of the American College of Foot and Ankle Surgeons,['10.1053/j.jfas.2019.09.038'] 9,32340423,[Effect of using scenario infiltration joint interactive training mode for junior nurse training in the prevention and treatment of pressure sore].,"Objective: To explore the application effect of scenario infiltration joint interactive training mode for junior nurse training in the prevention and treatment of pressure sore. Methods: A total of 118 junior nurses starting to work in the First Affiliated Hospital of Air Force Medical University from July 2017 to July 2018 met the inclusion criteria and were divided into routine training (RT) group and scenario infiltration joint interactive training (SIJIT) group using the random number table for prospective randomized controlled trial. There were 2 males and 57 females, aged (23.9±1.2) years in RT group and 3 males and 56 females, aged (23.5±1.3) years in SIJIT group. Before the training, nurses in both groups received theory and practical tests for the prevention and treatment of pressure sore with a homemade theory test paper and operation requirements designed by the training group. The training content was drawn up in 3 themes according to the weak points shown in the test. Nurses in RT group were trained in a large classroom with the help of multimedia teaching technique, and one lesson of 2 h targeting one theme was given once a week.Nurses in SIJIT group were trained by using the SIJIT mode, with online self-study for 2 weeks and then multimedia theory and practical teaching, and interaction in scene. After the training, theoretical and practical tests were conducted again in nurses of two groups. Satisfaction scores of nurses for the training mode, training effect, and curriculum design and answers to open questions about the degree of training satisfaction were investigated through homemade questionnaire for satisfaction degree. Homemade training contents and requirements questionnaire designed by the training group was used to understand the demands of nurses for training contents and requirements in 2 groups. Data were statistically analyzed with chi-square test and independent sample t test. Results: (1) The theoretical and practical scores on the prevention and treatment of pressure sore before the training were (78±11) and (83±10) points respectively in RT group, similar to (79±11) and (84±10) points in SIJIT group ( t =0.522, 0.615, P >0.05). The theoretical and operational scores on prevention and treatment of pressure score of nurses after the training were (90±8) and (92±5) points in SIJIT group, significantly higher than (82±10) and (85±9) points in RT group ( t =4.581, 5.259, P <0.01). (2) The satisfaction degree scores for training mode, curriculum design, and training effect of nurses in SIJIT group were significantly higher than those in RT group ( t =5.169, 7.976, 4.463, P <0.01). Nurses in the 2 groups were satisfied with the curriculum content, and unsatisfied with the curriculum time and the ways of test. (3) The top demand of the training nurses for curriculum content was the treatment of phase Ⅱ-Ⅲ pressure sore, accounting for 81.36% (96/118). Conclusions: The SIJIT has flexible training mode, and reasonable curriculum design and content, which significantly improves the theoretical and operational levels on prevention and treatment of pressure sore of the training nurses and receives recognition of the training nurses.",2020,"The theoretical and practical scores on the prevention and treatment of pressure sore before the training were (78±11) and (83±10) points respectively in RT group, similar to (79±11) and (84±10) points in SIJIT group ( t =0.522, 0.615, P >0.05).","['2 males and 57 females, aged (23.9±1.2) years in RT group and 3 males and 56 females, aged (23.5±1.3) years in SIJIT group', '118 junior nurses starting to work in the First Affiliated Hospital of Air Force Medical University from July 2017 to July 2018 met the inclusion criteria and were divided into']","['scenario infiltration joint interactive training mode for junior nurse training', 'routine training (RT) group and scenario infiltration joint interactive training (SIJIT']","['pressure sore', 'satisfaction degree scores']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517542', 'cui_str': '118'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0557351', 'cui_str': 'Employed'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332849', 'cui_str': 'Divide'}]","[{'cui': 'C0332448', 'cui_str': 'Infiltration'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0011127', 'cui_str': 'Pressure ulcer'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",118.0,0.0151408,"The theoretical and practical scores on the prevention and treatment of pressure sore before the training were (78±11) and (83±10) points respectively in RT group, similar to (79±11) and (84±10) points in SIJIT group ( t =0.522, 0.615, P >0.05).","[{'ForeName': 'Q', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': ""Department of Burns and Cutaneous Surgery, Burn Center of PLA, the First Affiliated Hospital, Air Force Medical University, Xi'an 710032, China.""}, {'ForeName': 'Q', 'Initials': 'Q', 'LastName': 'Zhou', 'Affiliation': ""Department of Burns and Cutaneous Surgery, Burn Center of PLA, the First Affiliated Hospital, Air Force Medical University, Xi'an 710032, China.""}, {'ForeName': 'X F', 'Initials': 'XF', 'LastName': 'Luo', 'Affiliation': ""Department of Burns and Cutaneous Surgery, Burn Center of PLA, the First Affiliated Hospital, Air Force Medical University, Xi'an 710032, China.""}, {'ForeName': 'N X', 'Initials': 'NX', 'LastName': 'Ma', 'Affiliation': ""Department of Burns and Cutaneous Surgery, Burn Center of PLA, the First Affiliated Hospital, Air Force Medical University, Xi'an 710032, China.""}, {'ForeName': 'C F', 'Initials': 'CF', 'LastName': 'Tong', 'Affiliation': ""Department of Burns and Cutaneous Surgery, Burn Center of PLA, the First Affiliated Hospital, Air Force Medical University, Xi'an 710032, China.""}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Xue', 'Affiliation': ""Department of Burns and Cutaneous Surgery, Burn Center of PLA, the First Affiliated Hospital, Air Force Medical University, Xi'an 710032, China.""}]",Zhonghua shao shang za zhi = Zhonghua shaoshang zazhi = Chinese journal of burns,['10.3760/cma.j.cn501120-20190108-00001'] 10,32346981,Predicting bone and soft tissue alterations of immediate implant sites in the esthetic zone using clinical parameters.,"BACKGROUND Immediate implantation is generally a predictable treatment, but sometimes there are significant tissue alterations at the surgical site which compromise clinical outcomes. PURPOSE This study aimed to investigate the association between tissue alterations and different clinical parameters in esthetic areas following immediate implant placement and provisionalization. MATERIALS AND METHODS Clinical parameters were measured at 36 non-grafted immediate implant sites enrolled in a randomized controlled trial. Alterations of bone and soft tissue were measured at 12 months after the treatment. Stepwise linear regression analysis was performed to analyze the association between different clinical parameters and outcomes of interest. RESULTS Gingival thickness 3 mm apical to the gingival margin (GT3) was positively associated with recession of mid-buccal gingival margin, while vertical distance between the buccal gingival margin and the crest (GM-bone) was negatively associated (P = .03, .01). Flap elevation and older age were positively associated with recession of the interproximal gingival margin (P = .04, .01). Horizontal defect dimension was positively associated with buccal ridge dimensional reduction while gingival thickness at free gingival margin (GT1) was negatively associated (P = .01, .04). Regarding interproximal bone level change, none of the clinical parameters was significantly associated. CONCLUSIONS Gingival phenotype was the only parameter significantly associated with both buccal gingival recession and buccal ridge dimensional reduction. It is important to assess clinical parameters before and during immediate implant procedure.",2020,"Flap elevation and older age were positively associated with recession of the interproximal gingival margin (P = .04, .01).",['Clinical parameters were measured at 36 non-grafted immediate implant sites enrolled in a randomized controlled trial'],['immediate implant placement and provisionalization'],"['Gingival thickness 3\u2009mm apical to the gingival margin (GT3', 'buccal gingival recession and buccal ridge dimensional reduction', 'Gingival phenotype', 'Flap elevation and older age', 'Alterations of bone and soft tissue', 'buccal ridge dimensional reduction while gingival thickness at free gingival margin (GT1']","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]","[{'cui': 'C0017562', 'cui_str': 'Gingival structure'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0205111', 'cui_str': 'Apical'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0442010', 'cui_str': 'Buccal'}, {'cui': 'C0017572', 'cui_str': 'Gingival recession'}, {'cui': 'C0332243', 'cui_str': 'Ridging'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0031437', 'cui_str': 'Phenotype'}, {'cui': 'C0038925', 'cui_str': 'Flap'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0231337', 'cui_str': 'Senility'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0225317', 'cui_str': 'Soft tissue'}, {'cui': 'C0332296', 'cui_str': 'Free of'}]",36.0,0.0323287,"Flap elevation and older age were positively associated with recession of the interproximal gingival margin (P = .04, .01).","[{'ForeName': 'Chun-Teh', 'Initials': 'CT', 'LastName': 'Lee', 'Affiliation': 'Department of Periodontics and Dental Hygiene, The University of Texas Health Science Center School of Dentistry, Houston, Texas, USA.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Sanz-Miralles', 'Affiliation': 'Division of Periodontics, Section of Oral and Diagnostic Sciences, Columbia University College of Dental Medicine, New York, New York, USA.'}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Zhu', 'Affiliation': 'Biostatistics & Epidemiology Research Design Core, Center for Clinical and Translational Sciences, Department of Internal Medicine, Medical School, The University of Texas Health Science Center at Houston, Houston, Texas, USA.'}, {'ForeName': 'Jaclyn', 'Initials': 'J', 'LastName': 'Glick', 'Affiliation': 'Private practice, Toronto, Ontario, Canada.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Heath', 'Affiliation': ""Department of Pediatric and Special Needs Dentistry, Arkansas Children's Hospital, Little Rock, Arkansas, USA.""}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Stoupel', 'Affiliation': 'Private practice, New York, New York, USA.'}]",Clinical implant dentistry and related research,['10.1111/cid.12910'] 11,32342619,Effect of metformin on cardiovascular risk factors in middle-aged Thai women with metabolic syndrome: A randomized placebo-controlled trial.,"AIM To evaluate the effect of metformin on cardiovascular risk factors in middle-aged Thai women with metabolic syndrome that are in menopausal transition. METHODS This study was double-blind randomized placebo-controlled trial. Metabolic syndrome was diagnosed using American Heart Association and National Heart, Lung, and Blood Institute criteria. After taking metformin 1700 mg/day for 6 months, cardiovascular risk factors were evaluated at baseline and month-6; the values of which were used to calculate delta (Δ, month-6 minus baseline values). RESULTS Forty menopausal participants were equally, randomized into either the placebo or metformin group. The two groups had comparable metabolic parameters at baseline, except that the mean triglyceride level was higher in the metformin group than in the placebo group. The significant improvements found only in the metformin group were body mass index, fasting blood glucose, high-sensitivity C-reactive protein and 10-year risk of coronary heart disease (Framingham heart study) (P = 0.0004, P = 0.049, P = 0.035 and P = 0.029); whereas that only in the placebo group was high density lipoprotein cholesterol. However, there was no statistically significant difference in the improvement between the two groups. CONCLUSION Metformin can improve some parameters of metabolic syndrome in middle-aged Thai women. Metformin is not superior to placebo for the improvement of cardiovascular risk factors.",2020,"The two groups had comparable metabolic parameters at baseline, except that the mean triglyceride level was higher in the metformin group than in the placebo group.","['middle-aged Thai women', 'middle-aged Thai women with metabolic syndrome that are in menopausal transition', 'Forty menopausal participants', 'middle-aged Thai women with metabolic syndrome']","['placebo or metformin', 'Metformin', 'metformin', 'placebo']","['body mass index, fasting blood glucose, high-sensitivity C-reactive protein and 10-year risk of coronary heart disease', 'density lipoprotein cholesterol', 'mean triglyceride level', 'cardiovascular risk factors', 'Metabolic syndrome', 'metabolic syndrome', 'metabolic parameters']","[{'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0039724', 'cui_str': 'Thai language'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}]","[{'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0065055', 'cui_str': 'lipoprotein cholesterol'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0202236', 'cui_str': 'Triglycerides measurement'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",40.0,0.321341,"The two groups had comparable metabolic parameters at baseline, except that the mean triglyceride level was higher in the metformin group than in the placebo group.","[{'ForeName': 'Suchada', 'Initials': 'S', 'LastName': 'Indhavivadhana', 'Affiliation': 'Gynecologic Endocrinology Unit, Department of Obstetrics and Gynecology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Manee', 'Initials': 'M', 'LastName': 'Rattanachaiyanont', 'Affiliation': 'Gynecologic Endocrinology Unit, Department of Obstetrics and Gynecology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Thanyarat', 'Initials': 'T', 'LastName': 'Wongwananurak', 'Affiliation': 'Gynecologic Endocrinology Unit, Department of Obstetrics and Gynecology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Kitirat', 'Initials': 'K', 'LastName': 'Techatraisak', 'Affiliation': 'Gynecologic Endocrinology Unit, Department of Obstetrics and Gynecology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Apiradee', 'Initials': 'A', 'LastName': 'Jirattigalachote', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Naresuan University, Phitsanulok, Thailand.'}, {'ForeName': 'Chongdee', 'Initials': 'C', 'LastName': 'Dangrat', 'Affiliation': 'Gynecologic Endocrinology Unit, Department of Obstetrics and Gynecology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}]",The journal of obstetrics and gynaecology research,['10.1111/jog.14263'] 12,32347208,"Yoga improves balance, mobility, and perceived occupational performance in adults with chronic brain injury: A preliminary investigation.","BACKGROUND AND PURPOSE This was a preliminary investigation to investigate potential benefits of group yoga, as past work has indicated that one-on-one yoga can improve functional deficits in adults with brain injury. MATERIALS AND METHODS Participants served as their own controls. Nine participants with chronic brain injury were recruited, and seven (four female) completed the study. Performance measures of balance and mobility and self-reported measures of balance confidence, pain, and occupational performance and satisfaction were used. Data were collected 3 times: baseline (study onset), pre-yoga (after an 8-week no-contact period), and post-yoga (after 8 weeks of yoga). Group yoga was led by a yoga instructor/occupational therapist, and sessions lasted 1 h and occurred twice a week. RESULTS No participants withdrew due to adverse effects from yoga. There were no significant changes between baseline and pre-yoga. Significant improvement was observed post-yoga in balance (p = 0.05), mobility (p = 0.03), and self-reported occupational performance (p = 0.04). CONCLUSION We observed significant improvements in balance, mobility, and self-reported occupational performance in adults with chronic brain injury.",2020,"Significant improvement was observed post-yoga in balance (p = 0.05), mobility (p = 0.03), and self-reported occupational performance (p = 0.04). ","['Nine participants with chronic brain injury were recruited, and seven (four female) completed the study', 'adults with brain injury', 'Participants served as their own controls', 'adults with chronic brain injury']",[],"['self-reported occupational performance', 'balance confidence, pain, and occupational performance and satisfaction', 'balance, mobility, and perceived occupational performance', 'functional deficits', 'balance, mobility, and self-reported occupational performance', 'mobility']","[{'cui': 'C0751813', 'cui_str': 'Chronic Brain Injury'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0270611', 'cui_str': 'Brain injury'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",[],"[{'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0521127', 'cui_str': 'Occupational'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0205245', 'cui_str': 'Functional'}]",9.0,0.0225685,"Significant improvement was observed post-yoga in balance (p = 0.05), mobility (p = 0.03), and self-reported occupational performance (p = 0.04). ","[{'ForeName': 'J A', 'Initials': 'JA', 'LastName': 'Stephens', 'Affiliation': 'Colorado State University, Department of Occupational Therapy, USA. Electronic address: jaclyn.stephens@colostate.edu.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Van Puymbroeck', 'Affiliation': 'Clemson University, Recreational Therapy Program, USA.'}, {'ForeName': 'P L', 'Initials': 'PL', 'LastName': 'Sample', 'Affiliation': 'Colorado State University, Department of Occupational Therapy, USA. Electronic address: pat.sample@colostate.edu.'}, {'ForeName': 'A A', 'Initials': 'AA', 'LastName': 'Schmid', 'Affiliation': 'Colorado State University, Department of Occupational Therapy, USA. Electronic address: arlene.schmid@colostate.edu.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2020.101172'] 13,32347209,"Evaluation of the effectiveness of self-healing training on self-compassion, body image concern, and recovery process in patients with skin cancer.","BACKGROUND AND PURPOSE The present study aimed to investigate the effect of self-healing training on self-compassion, body image concern, and recovery process in patients with skin cancer. MATERIALS AND METHODS The sample consisted of 34 volunteers who were purposefully selected and then randomly divided into experimental (n = 16) and control (n = 18) groups. The research instrument included the Self-Compassion Scale and Body Image Concern Inventory. The self-healing training intervention was then performed on the experimental group for twelve 90-min sessions. Finally, both groups underwent the post-test. Follow-up was performed two and four months after the post-test. RESULTS Self-healing training significantly increased self-compassion, including self-kindness, self-judgment, and sense of common humanity (p < 0.01), and decreased the level of body image concern, isolation, and over-identification (p < 0.05). CONCLUSION The self-healing is an appropriate intervention method to increase self-compassion and reduce body image concern and thus accelerate the process of skin cancer recovery.",2020,"RESULTS Self-healing training significantly increased self-compassion, including self-kindness, self-judgment, and sense of common humanity (p < 0.01), and decreased the level of body image concern, isolation, and over-identification (p < 0.05). ","['patients with skin cancer', '34 volunteers who were purposefully selected']",['self-healing training'],"['level of body image concern, isolation, and over-identification', 'self-compassion, including self-kindness, self-judgment, and sense of common humanity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007114', 'cui_str': 'Malignant neoplasm of skin'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C0885003', 'cui_str': 'Xiakucao'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0005891', 'cui_str': 'Body image'}, {'cui': 'C0037421', 'cui_str': 'Social isolation'}, {'cui': 'C0020792', 'cui_str': 'Identification - mental defense mechanism'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0022423', 'cui_str': 'Judgement'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0205214', 'cui_str': 'Common'}, {'cui': 'C0020157', 'cui_str': 'Humanities'}]",34.0,0.00947867,"RESULTS Self-healing training significantly increased self-compassion, including self-kindness, self-judgment, and sense of common humanity (p < 0.01), and decreased the level of body image concern, isolation, and over-identification (p < 0.05). ","[{'ForeName': 'Zohreh', 'Initials': 'Z', 'LastName': 'Latifi', 'Affiliation': 'Department of Psychology, Payame Noor University, PO BOX 19395-4697, Tehran, Iran. Electronic address: latifizh@gmail.com.'}, {'ForeName': 'Mozhgan', 'Initials': 'M', 'LastName': 'Soltani', 'Affiliation': 'Department of Psychology, Payame Noor University, PO BOX 19395-4697, Tehran, Iran.'}, {'ForeName': 'Shokoufeh', 'Initials': 'S', 'LastName': 'Mousavi', 'Affiliation': 'Department of Psychology, Payame Noor University, PO BOX 19395-4697, Tehran, Iran.'}]",Complementary therapies in clinical practice,['10.1016/j.ctcp.2020.101180'] 14,32341641,The Effect of Baseline Rescue Medication Use on Efficacy and Safety of Nebulized Glycopyrrolate Treatment in Patients with COPD from the GOLDEN 3 and 4 Studies.,"Purpose Rescue medication use is common in chronic obstructive pulmonary disease (COPD) patients and tends to increase with symptoms and disease severity. An analysis of baseline rescue medication use was conducted to inform on patient phenotypes and subsequent effects on lung function, symptoms, and safety following 12 weeks of nebulized glycopyrrolate (GLY) 25 µg twice daily or placebo in patients with moderate-to-very-severe COPD. Patients and Methods Pooled data from the 12-week, placebo-controlled GOLDEN 3 and 4 studies (n=781) were used to assign patients into quarters based on baseline rescue medication use (ie, average puffs-per-day) during the run-in period. Placebo-adjusted trough forced expiratory volume in 1 second (FEV 1 ), St. George's Respiratory Questionnaire (SGRQ) total score and EXAcerbations of COPD Tool-Respiratory Symptoms (EXACT-RS) total score data were reported; safety was evaluated by reviewing the incidence of adverse events (AEs) and serious AEs (SAEs). Results Baseline rescue medication use was a proxy for disease severity, evidenced by decreased lung function, increased health status scores, symptom scores and use of background long-acting β2-agonists and inhaled corticosteroids across quarters and treatment groups. Treatment with GLY led to greater improvements from baseline in trough FEV 1 , SGRQ and EXACT-RS scores compared with placebo in all rescue medication use quarters. Additionally, the SGRQ and EXACT-RS exhibited greater improvement with increased baseline rescue medication use with GLY treatment. In the Q4 patients, SGRQ (≥4-unit reduction) or EXACT-RS (≥2-unit reduction) responders were significantly greater with GLY compared with placebo. AE and SAE incidences were similar across quartiles. Conclusion These results suggest that baseline rescue medication use assessments may be useful in the management of COPD. Treatment with nebulized GLY improved lung function and symptom scores, regardless of baseline rescue medication use. These results support the use of nebulized GLY for the treatment of COPD, independent of baseline rescue medication use.",2020,"Treatment with GLY led to greater improvements from baseline in trough FEV 1 , SGRQ and EXACT-RS scores compared with placebo in all rescue medication use quarters.","['chronic obstructive pulmonary disease\xa0(COPD) patients', 'Patients with COPD from the GOLDEN 3 and 4 Studies', 'patients with moderate-to-very-severe COPD']","['nebulized GLY', 'Placebo', 'nebulized glycopyrrolate (GLY', 'Nebulized Glycopyrrolate', 'placebo']","['Efficacy and Safety', ""trough forced expiratory volume in 1 second (FEV 1 ), St. George's Respiratory Questionnaire (SGRQ) total score and EXAcerbations of COPD Tool-Respiratory Symptoms (EXACT-RS"", 'AE and SAE incidences', 'trough FEV 1 , SGRQ and EXACT-RS scores', 'lung function and symptom scores', 'lung function, increased health status scores, symptom scores and use of background long-acting β2-agonists and inhaled corticosteroids', 'incidence of adverse events (AEs) and serious AEs (SAEs']","[{'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C3641272', 'cui_str': 'Very severe'}]","[{'cui': 'C0017970', 'cui_str': 'Glycopyrrolate'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444506', 'cui_str': 'Trough'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0037090', 'cui_str': 'Respiratory symptom'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",781.0,0.110616,"Treatment with GLY led to greater improvements from baseline in trough FEV 1 , SGRQ and EXACT-RS scores compared with placebo in all rescue medication use quarters.","[{'ForeName': 'James F', 'Initials': 'JF', 'LastName': 'Donohue', 'Affiliation': 'Department of Pulmonary Diseases and Critical Care Medicine, University of North Carolina School of Medicine, Chapel Hill, NC, USA.'}, {'ForeName': 'Ayca', 'Initials': 'A', 'LastName': 'Ozol-Godfrey', 'Affiliation': 'Sunovion Pharmaceuticals Inc., Marlborough, MA, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Goodin', 'Affiliation': 'Sunovion Pharmaceuticals Inc., Marlborough, MA, USA.'}, {'ForeName': 'Shahin', 'Initials': 'S', 'LastName': 'Sanjar', 'Affiliation': 'Sunovion Pharmaceuticals Inc., Marlborough, MA, USA.'}]",International journal of chronic obstructive pulmonary disease,['10.2147/COPD.S242767'] 15,32346959,"Fixed combination of tazarotene and betamethasone dipropionate for treatment of psoriasis vulgaris: The result of a phase 3, multicenter, randomized controlled trial.","Long-term use of corticosteroids or local use of tazarotene (TAZ) alone for the treatment of psoriasis cause safety issues and low compliance rates. Combining these two may optimize their efficacy and minimize safety concerns. This study aimed to evaluate the clinical efficacy and safety of a fixed combination of TAZ 0.05% and betamethasone dipropionate 0.05% (BM) for psoriasis vulgaris. A multicenter, randomized, single-blinded, controlled phase 3 clinical trial was conducted. A total of 600 Chinese subjects with psoriasis vulgaris were randomized (3:1:1) to TAZ/BM cream, TAZ gel or BM cream groups for 6 weeks with an 8-week follow up. The primary efficacy assessment end-point was 75% improvement in Psoriasis Area and Severity Index (PASI-75) at 6 weeks. Secondary outcome assessments included PASI-90, percentage of PASI decrease and so forth. Safety and treatment-related adverse events were monitored throughout the study. Our results demonstrated that the TAZ/BM group exhibited statistically significant superiority in PASI-75 over TAZ (6.74% vs 1.67%) within 2 weeks. After 6 weeks of treatment, PASI-75 was 44.94% in the TAZ/BM group while 19.17% and 35.00% in the TAZ and BM group, respectively. At the 8-week follow up, the relapse rate of the TAZ/BM group was significantly lower than the BM group (10.62% vs 29.63%, P = 0.0269) though comparable with the TAZ group (10.00%). The most frequently reported treatment-related adverse event was mild to moderate level of skin irritation events. TAZ/BM combination has significant advantages over TAZ, including satisfying efficacy, rapid onset and reduced local stimulation. Meanwhile, compared with BM, it has the advantages of longer relief time and reduced clinical relapse rate. The TAZ/BM combination drug provides psoriatic patients an alternative drug with high efficacy and low relapse rate and safety concerns.",2020,The TAZ/BM combination drug provides psoriatic patients an alternative drug with high efficacy and low relapse rate and safety concerns.,"['600 Chinese subjects with psoriasis vulgaris', 'psoriasis vulgaris']","['betamethasone dipropionate', 'TAZ/BM', 'tazarotene (TAZ', 'TAZ', 'TAZ/BM cream, TAZ gel or BM cream', 'TAZ/BM combination', 'tazarotene and betamethasone dipropionate']","['PASI-90, percentage of PASI decrease and so forth', 'Safety and treatment-related adverse events', 'clinical efficacy and safety', 'Psoriasis Area and Severity Index (PASI-75', 'relapse rate']","[{'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0263361', 'cui_str': 'Psoriasis vulgaris'}]","[{'cui': 'C0053523', 'cui_str': 'Betamethasone dipropionate'}, {'cui': 'C0288792', 'cui_str': 'tazarotene'}, {'cui': 'C4517411', 'cui_str': '0.05'}, {'cui': 'C0775571', 'cui_str': 'Betamethasone (as betamethasone dipropionate) 500 microgram/g cutaneous cream'}, {'cui': 'C0017243', 'cui_str': 'Gel'}]","[{'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0087113', 'cui_str': 'Clinical Efficacy'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}]",600.0,0.0326387,The TAZ/BM combination drug provides psoriatic patients an alternative drug with high efficacy and low relapse rate and safety concerns.,"[{'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'Pathology Department, Institute of Dermatology and Hospital for Skin Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Nanjing, China.'}, {'ForeName': 'Jianfang', 'Initials': 'J', 'LastName': 'Sun', 'Affiliation': 'Pathology Department, Institute of Dermatology and Hospital for Skin Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Nanjing, China.'}, {'ForeName': 'Haizhen', 'Initials': 'H', 'LastName': 'Yang', 'Affiliation': 'Dermatology & STD, Peking University First Hospital, Peking, China.'}, {'ForeName': 'Qiuning', 'Initials': 'Q', 'LastName': 'Sun', 'Affiliation': 'Dermatology Department, Peking Union Medical College Hospital, Peking, China.'}, {'ForeName': 'Jianzhong', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': ""Dermatology Department, Peking University People's Hospital, Peking, China.""}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Gu', 'Affiliation': 'Dermatology Department, Changhai Hospital, Shanghai, China.'}, {'ForeName': 'Hai', 'Initials': 'H', 'LastName': 'Wen', 'Affiliation': 'Dermatology Department, Shanghai Changzheng Hospital, Shanghai, China.'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Li', 'Affiliation': 'Dermatology Department, Zhong Shan Hospital Fudan University, Shanghai, China.'}, {'ForeName': 'Xiaoming', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Dermatology Department, The University of Hong Kong-Shenzhen Hospital, Shenzhen, China.'}, {'ForeName': 'Huilan', 'Initials': 'H', 'LastName': 'Yang', 'Affiliation': 'Dermatology Department, General Hospital of Southern Theater of the Command, Guangzhou, China.'}, {'ForeName': 'Donghua', 'Initials': 'D', 'LastName': 'Lou', 'Affiliation': 'Department of Biostatistics, Nanjing Medical University, Nanjing, China.'}]",The Journal of dermatology,['10.1111/1346-8138.15349'] 16,32347779,"Re: Ejaculatory Hood Sparing versus Standard Laser Photoselective Vaporization of the Prostate: Sexual and Urodynamic Assessment through a Double Blinded, Randomized TrialA. E. Abolazm, A. S. El-Hefnawy, M. Laymon, A. B. Shehab-El-Din and A. M. Elshal J Urol 2020; 203: 792-801.",,2020,,[],['Re: Ejaculatory Hood Sparing Versus Standard Laser Photoselective Vaporization'],[],[],"[{'cui': 'C0013746', 'cui_str': 'Ejaculation'}, {'cui': 'C1843661', 'cui_str': 'Spastic Paraplegia, Ataxia, And Mental Retardation'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0348007', 'cui_str': 'Laser Ablation'}]",[],,0.41547,,"[{'ForeName': 'Sheng', 'Initials': 'S', 'LastName': 'Hu', 'Affiliation': 'Department of Geriatric Urology, Xiangya Hospital of Central South University, Changsha, Hu Nan, China.'}, {'ForeName': 'Xiaobo', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Department of Geriatric Urology, Xiangya Hospital of Central South University, Changsha, Hu Nan, China.'}, {'ForeName': 'Xiong', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Department of Geriatric Urology, Xiangya Hospital of Central South University, Changsha, Hu Nan, China.'}]",The Journal of urology,['10.1097/JU.0000000000001093'] 17,32347781,"Re: Ejaculatory Hood Sparing versus Standard Laser Photoselective Vaporization of the Prostate: Sexual and Urodynamic Assessment through a Double Blinded, Randomized Trial.",,2020,,[],['Re: Ejaculatory Hood Sparing versus Standard Laser Photoselective Vaporization'],[],[],"[{'cui': 'C0013746', 'cui_str': 'Ejaculation'}, {'cui': 'C1843661', 'cui_str': 'Spastic Paraplegia, Ataxia, And Mental Retardation'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0348007', 'cui_str': 'Laser Ablation'}]",[],,0.41547,,"[{'ForeName': 'A E', 'Initials': 'AE', 'LastName': 'Abolazm', 'Affiliation': ''}, {'ForeName': 'A S', 'Initials': 'AS', 'LastName': 'El-Hefnawy', 'Affiliation': ''}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Laymon', 'Affiliation': ''}, {'ForeName': 'A B', 'Initials': 'AB', 'LastName': 'Shehab-El-Din', 'Affiliation': ''}, {'ForeName': 'A M', 'Initials': 'AM', 'LastName': 'Elshal', 'Affiliation': ''}]",The Journal of urology,['10.1097/JU.0000000000001094'] 18,32341121,Dopamine and Risky Decision-Making in Gambling Disorder.,"Gambling disorder is a behavioral addiction associated with impairments in value-based decision-making and cognitive control. These functions are thought to be regulated by dopamine within fronto-striatal circuits, but the role of altered dopamine neurotransmission in the etiology of gambling disorder remains controversial. Preliminary evidence suggests that increasing frontal dopamine tone might improve cognitive functioning in gambling disorder. We therefore examined whether increasing frontal dopamine tone via a single dose of the catechol- O -methyltransferase (COMT) inhibitor tolcapone would reduce risky choice in human gamblers ( n  = 14) in a randomized double-blind placebo-controlled crossover study. Data were analyzed using hierarchical Bayesian parameter estimation and a combined risky choice drift diffusion model (DDM). Model comparison revealed a nonlinear mapping from value differences to trial-wise drift rates, confirming recent findings. An increase in risk-taking under tolcapone versus placebo was about five times more likely, given the data, than a decrease [Bayes factor (BF) = 0.2]. Examination of drug effects on diffusion model parameters revealed that an increase in the value dependency of the drift rate under tolcapone was about thirteen times more likely than a decrease (BF = 0.073). In contrast, a reduction in the maximum drift rate under tolcapone was about seven times more likely than an increase (BF = 7.51). Results add to previous work on COMT inhibitors in behavioral addictions and to mounting evidence for the applicability of diffusion models in value-based decision-making. Future work should focus on individual genetic, clinical and cognitive factors that might account for heterogeneity in the effects of COMT inhibition.",2020,"Gambling disorder is associated with impairments in value-based decision-making and cognitive control, functions regulated by the neurotransmitter dopamine.","['gambling disorder', 'human gamblers (n=14']","['catechol-O-methyltransferase (COMT) inhibitor tolcapone', 'Dopamine', 'frontal dopamine tone via the catechol-O-methyltransferase (COMT) inhibitor tolcapone', 'tolcapone vs. placebo', 'tolcapone', 'placebo']","['maximum drift rate under tolcapone', 'risky choice', 'value-dependency of the drift rate under tolcapone', 'cognitive functioning']","[{'cui': 'C0016995', 'cui_str': 'Gambling'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0858352', 'cui_str': 'Gambler'}]","[{'cui': 'C0007407', 'cui_str': 'Catechol methyltransferase'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0246330', 'cui_str': 'tolcapone'}, {'cui': 'C0013030', 'cui_str': 'Dopamine'}, {'cui': 'C0205123', 'cui_str': 'Coronal'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0246330', 'cui_str': 'tolcapone'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0011546', 'cui_str': 'Dependency, Psychology'}, {'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}]",,0.0953733,"Gambling disorder is associated with impairments in value-based decision-making and cognitive control, functions regulated by the neurotransmitter dopamine.","[{'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Peters', 'Affiliation': 'Department of Psychology, Biological Psychology, University of Cologne, Cologne 50923, Germany jan.peters@uni-koeln.de.'}, {'ForeName': 'Taylor', 'Initials': 'T', 'LastName': 'Vega', 'Affiliation': 'Department of Neurology, VA Northern California Healthcare System, San Francisco, CA 94121.'}, {'ForeName': 'Dawn', 'Initials': 'D', 'LastName': 'Weinstein', 'Affiliation': 'Department of Psychiatry.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Mitchell', 'Affiliation': 'Department of Psychiatry.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Kayser', 'Affiliation': 'Department of Neurology, VA Northern California Healthcare System, San Francisco, CA 94121.'}]",eNeuro,['10.1523/ENEURO.0461-19.2020'] 19,32347624,"Sulforaphane as an adjunctive treatment for irritability in children with autism spectrum disorder: A randomized, double-blind, placebo-controlled clinical trial.","AIM Irritability related to autism spectrum disorder (ASD) complicates the management of ASD patients at home and in clinical settings. In this randomized, double-blind, placebo-controlled clinical trial, we aimed to investigate the beneficial effects of adjuvant treatment with risperidone and sulforaphane in alleviating the irritability of children with ASD. METHODS Sixty drug-free patients aged 4-12 years were randomly assigned to one of two groups receiving risperidone plus sulforaphane or placebo. Risperidone was started with a daily dose of 0.25 mg in patients weighing <20 kg and 0.5 mg in those weighing ≥20 kg and increased stepwise to reach a maximum of 1 mg (<20 kg), 2.5 mg (20-45 kg), and 3.5 mg (>45 kg). Sulforaphane was administered at a daily dose of 50 μmol (≤45 kg) or 100 μmol (>45 kg). The participants were assessed with the Aberrant Behavior Checklist - Community Edition at baseline and at Weeks 5 and 10. RESULTS Compared to the placebo group, ASD patients in the sulforaphane group showed greater improvements in Irritability score (primary outcome measure; P = 0.001) and Hyperactivity/Noncompliance score (secondary outcome measure; P = 0.015), and significant Time × Treatment effect for Irritability (P = 0.007) and Hyperactivity/Noncompliance (P = 0.008). However, no difference was seen in improvements in the other secondary measures: Lethargy/Social Interaction score, Stereotypic Behavior score, Inappropriate Speech score, and frequency of adverse events. CONCLUSION Our results support the safety and efficacy of sulforaphane as an adjuvant to risperidone for improvement of irritability and hyperactivity symptoms in children with ASD.",2020,"However, no difference was seen in improvements in the other secondary measures: lethargy/social interaction, stereotypic behavior, inappropriate speech, and frequency of adverse events. ","['Sixty drug-free patients, aged 4-12\u2009years', 'ASD children', 'autistic patients at home and clinical settings', 'Autism Spectrum Disorder', 'ASD patients']","['risperidone plus sulforaphane or placebo', 'risperidone and sulforaphane', 'sulforaphane', 'Sulforaphane', 'risperidone', 'Risperidone', 'placebo']","['hyperactivity/noncompliance', 'Aberrant Behavior Checklist-Community (ABC-C', 'irritability', 'secondary measures: lethargy/social interaction, stereotypic behavior, inappropriate speech, and frequency of adverse events', 'irritability and hyperactivity symptoms']","[{'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004352', 'cui_str': 'Autistic disorder'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}]","[{'cui': 'C0073393', 'cui_str': 'Risperidone'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0163159', 'cui_str': 'sulforafan'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0424295', 'cui_str': 'Hyperactive behavior'}, {'cui': 'C0376405', 'cui_str': 'Noncompliance with treatment'}, {'cui': 'C0443127', 'cui_str': 'Aberrant'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0022107', 'cui_str': 'Feeling irritable'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0023380', 'cui_str': 'Lethargy'}, {'cui': 'C0037420', 'cui_str': 'Interaction with others'}, {'cui': 'C0038271', 'cui_str': 'Stereotyped routines'}, {'cui': 'C1168248', 'cui_str': 'Inappropriate speech'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",,0.667456,"However, no difference was seen in improvements in the other secondary measures: lethargy/social interaction, stereotypic behavior, inappropriate speech, and frequency of adverse events. ","[{'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Momtazmanesh', 'Affiliation': 'Psychiatric Research Center, Roozbeh Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Zeinab', 'Initials': 'Z', 'LastName': 'Amirimoghaddam-Yazdi', 'Affiliation': 'Psychiatric Research Center, Roozbeh Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hossein Sanjari', 'Initials': 'HS', 'LastName': 'Moghaddam', 'Affiliation': 'Psychiatric Research Center, Roozbeh Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohammad Reza', 'Initials': 'MR', 'LastName': 'Mohammadi', 'Affiliation': 'Psychiatric Research Center, Roozbeh Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Shahin', 'Initials': 'S', 'LastName': 'Akhondzadeh', 'Affiliation': 'Psychiatric Research Center, Roozbeh Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}]",Psychiatry and clinical neurosciences,['10.1111/pcn.13016'] 20,32347763,Dupilumab provides rapid and sustained improvement in SCORAD outcomes in adults with moderate-to-severe atopic dermatitis: combined results of four randomized phase 3 trials.,"Background: Dupilumab, a first-in-class therapy targeting the two key cytokines involved in the persistent underlying inflammatory pathway in atopic dermatitis (AD), is approved for treatment of moderate-to-severe AD in Europe, USA, Japan and several other countries. Objective: To assess dupilumab effects on SCORing Atopic Dermatitis (SCORAD) and component scores (objective and subjective SCORAD) over time in adults with moderate-to-severe AD. Methods: This post hoc analysis included 2,444 patients in four placebo-controlled, double-blind, randomized, phase 3 trials. SOLO 1 and 2 (NCT02277743; NCT02277769) evaluated 16 weeks of dupilumab monotherapy against placebo. CAFÉ (NCT02755649) and CHRONOS (NCT02260986) evaluated dupilumab with concomitant topical corticosteroids (TCS) against TCS alone for 16 and 52 weeks, respectively. Results: 2,444 patients randomized to treatment in SOLO 1 and 2 ( N  = 1,379), CAFÉ ( N  = 325) and CHRONOS ( N  = 740) were analyzed. Dupilumab treatment significantly improved overall SCORAD and individual components as early as Week 1 or 2, with significant and clinically meaningful differences vs. control through end of treatment ( p  < .0001). These results occurred irrespective of dupilumab regimen, 300 mg subcutaneously weekly or every 2 weeks. Conclusions: In four large phase 3 trials in adults with moderate-to-severe AD, dupilumab treatment with or without concomitant TCS resulted in rapid and sustained improvements in all SCORAD outcomes vs. placebo or TCS alone.",2020,"Dupilumab treatment significantly improved overall SCORAD and individual components as early as Week 1 or 2, with significant and clinically meaningful differences vs. control through end of treatment ( p  < 0.0001).","['2,444 patients randomized to treatment in SOLO 1&2', '2,444 patients in four', 'atopic dermatitis (AD', 'adults with moderate-to-severe atopic dermatitis', 'adults with moderate-to-severe AD']","['dupilumab monotherapy against placebo', 'TCS', 'dupilumab with concomitant topical corticosteroids (TCS) against TCS', 'placebo']","['SCORAD outcomes', 'SCORing Atopic Dermatitis (SCORAD) and component scores (objective and subjective SCORAD', 'overall SCORAD and individual components']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0011615', 'cui_str': 'Atopic dermatitis'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}]","[{'cui': 'C3660996', 'cui_str': 'dupilumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0242387', 'cui_str': 'Treacher Collins syndrome'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}]","[{'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0011615', 'cui_str': 'Atopic dermatitis'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0027361', 'cui_str': 'Person'}]",2444.0,0.352091,"Dupilumab treatment significantly improved overall SCORAD and individual components as early as Week 1 or 2, with significant and clinically meaningful differences vs. control through end of treatment ( p  < 0.0001).","[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Barbarot', 'Affiliation': 'Service de Dermatologie, Centre Hospitalier Universitaire de Nantes , Nantes , France.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Wollenberg', 'Affiliation': 'Department of Dermatology and Allergy, Ludwig-Maximilian University , Munich , Germany.'}, {'ForeName': 'J I', 'Initials': 'JI', 'LastName': 'Silverberg', 'Affiliation': 'Department of Dermatology, The George Washington University School of Medicine and Health Sciences , Washington , DC , USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Deleuran', 'Affiliation': 'Department of Dermatology, Aarhus University Hospital , Aarhus , Denmark.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Pellacani', 'Affiliation': 'Department of Dermatology, University of Modena and Reggio Emilia , Modena , Italy.'}, {'ForeName': 'J C', 'Initials': 'JC', 'LastName': 'Armario-Hita', 'Affiliation': 'Service of Dermatology, University Hospital of Puerto Real, University of Cádiz , Cádiz , Spain.'}, {'ForeName': 'Z', 'Initials': 'Z', 'LastName': 'Chen', 'Affiliation': 'Regeneron Pharmaceuticals, Inc. , Tarrytown , NY , USA.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Shumel', 'Affiliation': 'Regeneron Pharmaceuticals, Inc. , Tarrytown , NY , USA.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Eckert', 'Affiliation': 'Sanofi , Chilly-Mazarin , France.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Gadkari', 'Affiliation': 'Regeneron Pharmaceuticals, Inc. , Tarrytown , NY , USA.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Lu', 'Affiliation': 'Regeneron Pharmaceuticals, Inc. , Tarrytown , NY , USA.'}, {'ForeName': 'A B', 'Initials': 'AB', 'LastName': 'Rossi', 'Affiliation': 'Sanofi Genzyme , Cambridge , MA , USA.'}]",The Journal of dermatological treatment,['10.1080/09546634.2020.1750550'] 21,32348007,"A randomized, multicenter and noninferiority study of amoxicillin plus berberine vs tetracycline plus furazolidone in quadruple therapy for Helicobacter pylori rescue treatment.","OBJECTIVE Helicobacter pylori (H. pylori) infection is closely associated with gastric ulcers and gastric adenocarcinomas. We aimed to assess the efficacy and safety of a quadruple regimen with amoxicillin plus berberine vs tetracycline plus furazolidone in rescue therapy for H. pylori eradication. METHODS We conducted a randomized, open-label, multicenter, noninferiority trial. Patients with previous treatment failures recruited from five centers were randomized (1:1) to receive a regimen with esomeprazole and bismuth plus either berberine and amoxicillin (the BA group) or tetracycline and furazolidone (the TF group) for 14 days. Their H. pylori infection status was confirmed 4-8 weeks after treatment. The primary outcome was the eradication rate. The secondary outcomes included the rates of symptom improvement, compliance, and adverse events. This study was registered at ClinicalTrials.gov (NCT03609892). RESULTS Altogether 658 participants were consecutively enrolled. An intention-to-treat analysis demonstrated that the two regimens achieved a similar eradication rate (76.3% vs 77.5%; P = 0.781). The per-protocol analysis reached a similar result (81.5% vs 85.0%; P = 0.278). The eradication rate reached in the BA group was greater than the pre-established margin of noninferiority, at -10% (the lower bounds of the 95% CI were -7.66% and -9.43%, respectively). The rate of adverse events was lower for the BA group than the TF group (18.5% vs 26.1%, P = 0.024). Rates of compliance and symptom improvement were similar for the two therapies. CONCLUSION The efficacy of both regimens in rescue treatment for H. pylori eradication was satisfactory, 14-day BA-based quadruple therapy is noninferior to the TF-based therapy.",2020,"The rate of adverse events was lower for BA than TF therapy (18.5% vs 26.1%, P = 0.024).","['Subjects with previous treatment failures recruited from 5 centers', 'gastric ulcers and gastric adenocarcinoma', '658 subjects were consecutively enrolled in total']","['esomeprazole and bismuth plus either berberine and amoxicillin (BA group) or tetracycline and furazolidone (TF group', 'amoxicillin plus berberine vs tetracycline plus furazolidone', 'Amoxicillin plus Berberine vs Tetracycline plus Furazolidone']","['rate of adverse events', 'rates of symptom improvement, compliance and adverse events', 'rates of compliance and symptom improvement', 'H. pylori infection status', 'eradication rate', 'efficacy and safety']","[{'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0521983', 'cui_str': 'Absence of therapeutic response'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0038358', 'cui_str': 'Gastric ulcer'}, {'cui': 'C0278701', 'cui_str': 'Adenocarcinoma of stomach'}, {'cui': 'C0439810', 'cui_str': 'Total'}]","[{'cui': 'C0937846', 'cui_str': 'Esomeprazole'}, {'cui': 'C0005642', 'cui_str': 'Bismuth'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0005117', 'cui_str': 'Berberine'}, {'cui': 'C0002645', 'cui_str': 'Amoxicillin'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0039644', 'cui_str': 'Tetracycline'}, {'cui': 'C0016855', 'cui_str': 'Furazolidone'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0850666', 'cui_str': 'Infection caused by Helicobacter pylori'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",658.0,0.115176,"The rate of adverse events was lower for BA than TF therapy (18.5% vs 26.1%, P = 0.024).","[{'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': ""State Key Laboratory of Cancer Biology, National Clinical Research Center for Digestive Diseases, Xijing Hospital of Digestive Diseases, Air Force Military Medical University, Xi'an, Shaanxi Province, China.""}, {'ForeName': 'Chuan', 'Initials': 'C', 'LastName': 'Han', 'Affiliation': ""State Key Laboratory of Cancer Biology, National Clinical Research Center for Digestive Diseases, Xijing Hospital of Digestive Diseases, Air Force Military Medical University, Xi'an, Shaanxi Province, China.""}, {'ForeName': 'Wen Quan', 'Initials': 'WQ', 'LastName': 'Lu', 'Affiliation': 'Department of Gastroenterology, First Affiliated Hospital of Zhengzhou University, Zhengzhou, Henan Province, China.'}, {'ForeName': 'Na', 'Initials': 'N', 'LastName': 'Wang', 'Affiliation': ""State Key Laboratory of Cancer Biology, National Clinical Research Center for Digestive Diseases, Xijing Hospital of Digestive Diseases, Air Force Military Medical University, Xi'an, Shaanxi Province, China.""}, {'ForeName': 'Si Ran', 'Initials': 'SR', 'LastName': 'Wu', 'Affiliation': ""State Key Laboratory of Cancer Biology, National Clinical Research Center for Digestive Diseases, Xijing Hospital of Digestive Diseases, Air Force Military Medical University, Xi'an, Shaanxi Province, China.""}, {'ForeName': 'Yong Xi', 'Initials': 'YX', 'LastName': 'Wang', 'Affiliation': 'Department of Gastroenterology, Xianyang Central Hospital, Xianyang, Shaanxi Province, China.'}, {'ForeName': 'Jin Ping', 'Initials': 'JP', 'LastName': 'Ma', 'Affiliation': 'Department of Gastroenterology, Xianyang Central Hospital, Xianyang, Shaanxi Province, China.'}, {'ForeName': 'Jie Hong', 'Initials': 'JH', 'LastName': 'Wang', 'Affiliation': 'Department of Gastroenterology, Affiliated Hospital of Shaanxi University of Chinese Medicine, Xianyang, Shaanxi Province, China.'}, {'ForeName': 'Cheng', 'Initials': 'C', 'LastName': 'Hao', 'Affiliation': 'Department of Gastroenterology, Affiliated Hospital of Shaanxi University of Chinese Medicine, Xianyang, Shaanxi Province, China.'}, {'ForeName': 'Dong Hong', 'Initials': 'DH', 'LastName': 'Yuan', 'Affiliation': ""Department of Gastroenterology, Yan'an University Affiliated Hospital, Yan'an, Shaanxi Province, China.""}, {'ForeName': 'Na', 'Initials': 'N', 'LastName': 'Liu', 'Affiliation': ""Department of Gastroenterology, Second Affiliated Hospital of Xi'an Jiaotong University, Xi'an, Shaanxi Province, China.""}, {'ForeName': 'Yong Quan', 'Initials': 'YQ', 'LastName': 'Shi', 'Affiliation': ""State Key Laboratory of Cancer Biology, National Clinical Research Center for Digestive Diseases, Xijing Hospital of Digestive Diseases, Air Force Military Medical University, Xi'an, Shaanxi Province, China.""}]",Journal of digestive diseases,['10.1111/1751-2980.12870'] 22,32343642,"Irinotecan, Temozolomide, and Dinutuximab With GM-CSF in Children With Refractory or Relapsed Neuroblastoma: A Report From the Children's Oncology Group.","PURPOSE The combination of irinotecan, temozolomide, dintuximab, and granulocyte-macrophage colony-stimulating factor (I/T/DIN/GM-CSF) demonstrated activity in patients with relapsed/refractory neuroblastoma in the randomized Children's Oncology Group ANBL1221 trial. To more accurately assess response rate and toxicity, an expanded cohort was nonrandomly assigned to I/T/DIN/GM-CSF. PATIENTS AND METHODS Patients were eligible at first relapse or first designation of refractory disease. Oral T and intravenous (IV) irinotecan were administered on days 1 to 5 of 21-day cycles. DIN was administered IV (days 2-5), and GM-CSF was administered subcutaneously (days 6-12). The primary end point was objective response, analyzed on an intent-to-treat basis per the International Neuroblastoma Response Criteria. RESULTS Seventeen eligible patients were randomly assigned to I/T/DIN/GM-CSF (February 2013 to March 2015); 36 additional patients were nonrandomly assigned to I/T/DIN/GM-CSF (August 2016 to May 2017). Objective (complete or partial) responses were observed in nine (52.9%) of 17 randomly assigned patients (95% CI, 29.2% to 76.7%) and 13 (36.1%) of 36 expansion patients (95% CI, 20.4% to 51.8%). Objective responses were seen in 22 (41.5%) of 53 patients overall (95% CI, 28.2% to 54.8%); stable disease was also observed in 22 of 53. One-year progression-free and overall survival for all patients receiving I/T/DIN/GM-CSF were 67.9% ± 6.4% (95% CI, 55.4% to 80.5%) and 84.9% ± 4.9% (95% CI, 75.3% to 94.6%), respectively. Two patients did not receive protocol therapy and were evaluable for response but not toxicity. Common grade ≥ 3 toxicities were fever/infection (18 [35.3%] of 51), neutropenia (17 [33.3%] of 51), pain (15 [29.4%] of 51), and diarrhea (10 [19.6%] of 51). One patient met protocol-defined criteria for unacceptable toxicity (grade 4 hypoxia). Higher DIN trough levels were associated with response. CONCLUSION I/T/DIN/GM-CSF has significant antitumor activity in patients with relapsed/refractory neuroblastoma. Study of chemoimmunotherapy in the frontline setting is indicated, as is further evaluation of predictive biomarkers.",2020,"Objective responses were seen in 22 (41.5%) of 53 patients overall (95% CI, 28.2% to 54.8%); stable disease was also observed in 22 of 53.","['Seventeen eligible patients', ""patients with relapsed/refractory neuroblastoma in the randomized Children's Oncology Group"", 'Patients were eligible at first relapse or first designation of refractory disease', 'Children With Refractory or Relapsed Neuroblastoma', 'patients with relapsed/refractory neuroblastoma']","['Irinotecan, Temozolomide, and Dinutuximab With GM-CSF', 'chemoimmunotherapy', 'irinotecan, temozolomide, dintuximab, and granulocyte-macrophage colony-stimulating factor (I/T/DIN/GM-CSF', 'Oral T and intravenous (IV) irinotecan']","['Higher DIN trough levels', 'diarrhea', 'objective response, analyzed on an intent-to-treat basis per the International Neuroblastoma Response Criteria', 'neutropenia', 'response rate and toxicity', 'Objective (complete or partial) responses', 'overall survival', 'toxicity', 'fever/infection', 'stable disease', 'pain', 'antitumor activity', 'Objective responses']","[{'cui': 'C0450331', 'cui_str': '17'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0027819', 'cui_str': 'Neuroblastoma'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0600091', 'cui_str': 'Identifier'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0278695', 'cui_str': 'Neuroblastoma recurrent'}]","[{'cui': 'C0123931', 'cui_str': 'irinotecan'}, {'cui': 'C0076080', 'cui_str': 'temozolomide'}, {'cui': 'C0281581', 'cui_str': 'dinutuximab'}, {'cui': 'C0079460', 'cui_str': 'Colony-stimulating factor, granulocyte-macrophage'}, {'cui': 'C0018183', 'cui_str': 'Granulocyte'}, {'cui': 'C0079784', 'cui_str': 'Colony-stimulating factor, macrophage'}, {'cui': 'C0574277', 'cui_str': 'Dinka language'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0574277', 'cui_str': 'Dinka language'}, {'cui': 'C0444506', 'cui_str': 'Trough'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0027819', 'cui_str': 'Neuroblastoma'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",17.0,0.0930635,"Objective responses were seen in 22 (41.5%) of 53 patients overall (95% CI, 28.2% to 54.8%); stable disease was also observed in 22 of 53.","[{'ForeName': 'Rajen', 'Initials': 'R', 'LastName': 'Mody', 'Affiliation': ""C.S. Mott Children's Hospital, University of Michigan, Ann Arbor, MI.""}, {'ForeName': 'Alice L', 'Initials': 'AL', 'LastName': 'Yu', 'Affiliation': 'University of California San Diego, San Diego, CA.'}, {'ForeName': 'Arlene', 'Initials': 'A', 'LastName': 'Naranjo', 'Affiliation': ""Children's Oncology Group Statistics and Data Center, University of Florida, Gainesville, FL.""}, {'ForeName': 'Fan F', 'Initials': 'FF', 'LastName': 'Zhang', 'Affiliation': ""Children's Oncology Group Statistics and Data Center, Monrovia, CA.""}, {'ForeName': 'Wendy B', 'Initials': 'WB', 'LastName': 'London', 'Affiliation': 'Dana-Farber Cancer Institute and Harvard Medical School, Boston, MA.'}, {'ForeName': 'Barry L', 'Initials': 'BL', 'LastName': 'Shulkin', 'Affiliation': ""St Jude Children's Research Hospital and University of Tennessee Health Science Center, Memphis, TN.""}, {'ForeName': 'Marguerite T', 'Initials': 'MT', 'LastName': 'Parisi', 'Affiliation': ""Seattle Children's Hospital and University of Washington, Seattle, WA.""}, {'ForeName': 'Sabah-E-Noor', 'Initials': 'SE', 'LastName': 'Servaes', 'Affiliation': ""Children's Hospital of Philadelphia and University of Pennsylvania, Philadelphia, PA.""}, {'ForeName': 'Mitchell B', 'Initials': 'MB', 'LastName': 'Diccianni', 'Affiliation': 'University of California San Diego, San Diego, CA.'}, {'ForeName': 'Jacquelyn A', 'Initials': 'JA', 'LastName': 'Hank', 'Affiliation': 'University of Wisconsin, Madison, WI.'}, {'ForeName': 'Mildred', 'Initials': 'M', 'LastName': 'Felder', 'Affiliation': 'University of Wisconsin, Madison, WI.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Birstler', 'Affiliation': 'University of Wisconsin, Madison, WI.'}, {'ForeName': 'Paul M', 'Initials': 'PM', 'LastName': 'Sondel', 'Affiliation': 'University of Wisconsin, Madison, WI.'}, {'ForeName': 'Shahab', 'Initials': 'S', 'LastName': 'Asgharzadeh', 'Affiliation': ""Children's Hospital of Los Angeles and University of Southern California, Los Angeles, CA.""}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Glade-Bender', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'Katzenstein', 'Affiliation': ""Nemour's Children's Clinic, Jacksonville, FL.""}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Maris', 'Affiliation': ""Children's Hospital of Philadelphia and University of Pennsylvania, Philadelphia, PA.""}, {'ForeName': 'Julie R', 'Initials': 'JR', 'LastName': 'Park', 'Affiliation': ""Seattle Children's Hospital and University of Washington, Seattle, WA.""}, {'ForeName': 'Rochelle', 'Initials': 'R', 'LastName': 'Bagatell', 'Affiliation': ""Children's Hospital of Philadelphia and University of Pennsylvania, Philadelphia, PA.""}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.20.00203'] 23,32344650,"The Effect of Vitamin D 3 Supplementation on Hepcidin, Iron, and IL-6 Responses after a 100 km Ultra-Marathon.","Deficiencies in iron and vitamin D are frequently observed in athletes. Therefore, we examined whether different baseline vitamin D 3 levels have any impact on post-exercise serum hepcidin, IL-6 and iron responses in ultra-marathon runners. In this randomized control trial, the subjects (20 male, amateur runners, mean age 40.75 ± 7.15 years) were divided into two groups: experimental (VD) and control (CON). The VD group received vitamin D 3 (10,000 UI/day) and the CON group received a placebo for two weeks before the run. Venous blood samples were collected on three occasions-before the run, after the 100 km ultra-marathon and 12 h after the run-to measure iron metabolism indicators, hepcidin, and IL-6 concentration. After two weeks of supplementation, the intervention group demonstrated a higher level of serum 25(OH)D than the CON group (27.82 ± 5.8 ng/mL vs. 20.41 ± 4.67 ng/mL; p < 0.05). There were no differences between the groups before and after the run in the circulating hepcidin and IL-6 levels. The decrease in iron concentration immediately after the 100-km ultra-marathon was smaller in the VD group than CON ( p < 0.05). These data show that various vitamin D 3 status can affect the post-exercise metabolism of serum iron.",2020,There were no differences between the groups before and after the run in the circulating hepcidin and IL-6 levels.,"['subjects (20 male, amateur runners, mean age 40.75 ± 7.15 years', 'ultra-marathon runners']","['vitamin D', 'CON', 'Vitamin D 3 Supplementation', 'placebo']","['circulating hepcidin and IL-6 levels', 'Venous blood samples', 'higher level of serum 25(OH)D', 'iron metabolism indicators, hepcidin, and IL-6 concentration', 'Hepcidin, Iron, and IL-6 Responses', 'iron concentration']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0168374', 'cui_str': 'Marathon composite resin'}]","[{'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0966897', 'cui_str': 'Hepcidin'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0444255', 'cui_str': 'Venous blood specimen'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",,0.0673047,There were no differences between the groups before and after the run in the circulating hepcidin and IL-6 levels.,"[{'ForeName': 'Katarzyna', 'Initials': 'K', 'LastName': 'Kasprowicz', 'Affiliation': 'Department of Molecular Biology, Gdansk University of Physical Education and Sport, 80-336 Gdansk, Poland.'}, {'ForeName': 'Wojciech', 'Initials': 'W', 'LastName': 'Ratkowski', 'Affiliation': 'Department of Athletics, Gdansk University of Physical Education and Sport, 80-336 Gdansk, Poland.'}, {'ForeName': 'Wojciech', 'Initials': 'W', 'LastName': 'Wołyniec', 'Affiliation': 'Department of Occupational, Metabolic and Internal Diseases, Medical University of Gdansk, 81-519 Gdynia, Poland.'}, {'ForeName': 'Mariusz', 'Initials': 'M', 'LastName': 'Kaczmarczyk', 'Affiliation': 'Department of Clinical and Molecular Biochemistry, Pomeranian Medical University, 70-11 Szczecin, Poland.'}, {'ForeName': 'Konrad', 'Initials': 'K', 'LastName': 'Witek', 'Affiliation': 'Department of Biochemistry, Institute of Sport, National Research Institute, 01-982 Warsaw, Poland.'}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Żmijewski', 'Affiliation': 'Faculty of Physical Education, Jozef Piłsudski University of Physical Education in Warsaw, 01-813 Warsaw, Poland.'}, {'ForeName': 'Marcin', 'Initials': 'M', 'LastName': 'Renke', 'Affiliation': 'Department of Occupational, Metabolic and Internal Diseases, Medical University of Gdansk, 81-519 Gdynia, Poland.'}, {'ForeName': 'Zbigniew', 'Initials': 'Z', 'LastName': 'Jastrzębski', 'Affiliation': 'Department of Physiology, Gdansk University of Physical Education and Sport, 80-336 Gdansk, Poland.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Rosemann', 'Affiliation': 'Institute of Primary Care, University of Zurich, 8091 Zurich, Switzerland.'}, {'ForeName': 'Pantelis T', 'Initials': 'PT', 'LastName': 'Nikolaidis', 'Affiliation': 'Exercise Physiology Laboratory, 18450 Nikaia, Greece.'}, {'ForeName': 'Beat', 'Initials': 'B', 'LastName': 'Knechtle', 'Affiliation': 'Institute of Primary Care, University of Zurich, 8091 Zurich, Switzerland.'}]",International journal of environmental research and public health,['10.3390/ijerph17082962'] 24,32344728,Impact of Active and Passive Hypoxia as Re-Warm-Up Activities on Rugby Players' Performance.,"The aim of this study was to analyse the effect of four types of re-warm-up (R-WU) activity, namely rest in normoxia (RN) at FiO 2 = 20.9%, rest in hypoxia (RH) at FiO 2 = 15%, activity (4 × 5 jumps/15 s) in normoxia (AN) and activity in hypoxia (AH) on physical performance. Ten elite male rugby players completed a 15-min warm-up followed by one of the 15-min randomized R-WU strategies. After R-WU, countermovement jump (CMJ), 20 m sprint and repeat sprint ability (RSA) tests were assessed. Compared to passive strategies (RN and RH), tympanic temperature was higher after active R-WU (AN and AH) ( p = 0.016). Higher values of CMJ height ( p = 0.037) and 20 m sprint ( p = 0.02) were found in AH than in RN. In addition, mean RSA was lower ( p = 0.008) in AH than in RN and RH. Blood lactate concentration was higher ( p = 0.007) after RN and AN strategies than after AH. Muscle O 2 saturation ( p = 0.021) and total Hb ( p = 0.042) were higher after AH than after the other three conditions and after RN, respectively. Therefore, an active R-WU under hypoxia could be useful to elite rugby players, once it had attenuated the decline in tympanic temperature during a 15-min period after warm-up, improving jump, sprint and RSA performance.",2020,"Muscle O 2 saturation ( p = 0.021) and total Hb ( p = 0.042) were higher after AH than after the other three conditions and after RN, respectively.",['Ten elite male rugby players'],"['re-warm-up (R-WU) activity, namely rest in normoxia (RN', 'Active and Passive Hypoxia as Re-Warm-Up Activities']","['mean RSA', 'Muscle O 2 saturation', 'countermovement jump (CMJ), 20 m sprint and repeat sprint ability (RSA) tests', 'CMJ height', 'total Hb', 'normoxia (AN) and activity in hypoxia (AH) on physical performance', 'passive strategies (RN and RH), tympanic temperature', 'Blood lactate concentration']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0035945', 'cui_str': 'Rugby'}]","[{'cui': 'C2350169', 'cui_str': 'Warming-Up Exercise'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0522534', 'cui_str': 'Saturated'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C1532039', 'cui_str': 'Tympanic temperature'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",10.0,0.034329,"Muscle O 2 saturation ( p = 0.021) and total Hb ( p = 0.042) were higher after AH than after the other three conditions and after RN, respectively.","[{'ForeName': 'Domingo Jesús', 'Initials': 'DJ', 'LastName': 'Ramos-Campo', 'Affiliation': 'Faculty of Sports, UCAM, Catholic University San Antonio, 30107 Murcia, Spain.'}, {'ForeName': 'João', 'Initials': 'J', 'LastName': 'Malta', 'Affiliation': 'Departamento de Desporto e Saúde, Escola de Ciências e Tecnologia, Universidade de Évora, 7000-645 Évora, Portugal.'}, {'ForeName': 'Guillermo', 'Initials': 'G', 'LastName': 'Olcina', 'Affiliation': 'Faculty of Sport Sciences, University of Extremadura, 10003 Cáceres, Spain.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Timón', 'Affiliation': 'Faculty of Sport Sciences, University of Extremadura, 10003 Cáceres, Spain.'}, {'ForeName': 'Armando', 'Initials': 'A', 'LastName': 'Raimundo', 'Affiliation': 'Departamento de Desporto e Saúde, Escola de Ciências e Tecnologia, Universidade de Évora, 7000-645 Évora, Portugal.'}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Tomas-Carus', 'Affiliation': 'Departamento de Desporto e Saúde, Escola de Ciências e Tecnologia, Universidade de Évora, 7000-645 Évora, Portugal.'}]",International journal of environmental research and public health,['10.3390/ijerph17082971'] 25,32344167,Umifenovir treatment is not associated with improved outcomes in patients with coronavirus disease 2019: a retrospective study.,"OBJECTIVES Coronavirus disease 2019 (COVID-19) is caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Umifenovir (Arbidol®) is an antiviral drug being used to treat influenza in Russia and China. This study aimed to investigate the effectiveness and safety of umifenovir for COVID-19. METHODS A retrospective study was performed in a non-intensive care unit (ICU) ward in Jinyintan Hospital from 2 February 2020 to 20 March 2020. COVID-19 was confirmed by real-time reverse-transcriptase polymerase chain reaction (RT-PCR) assay of pharyngeal swab specimens. The confirmed patients were divided into the umifenovir group and the control group according to the use of umifenovir. The main outcomes were the rate of negative pharyngeal swab tests for SARS-CoV-2 within 1 week after admission and the time for the virus to turn negative. The negativity time of SARS-CoV-2 was defined as the first day of a negative test if the nucleic acid of SARS-CoV-2 was negative for two consecutive tests. RESULTS A total of 81 COVID-19 patients were included, with 45 in the umifenovir group and 36 in the control group. Baseline clinical and laboratory characteristics were comparable between the two groups. Thirty-three out of 45 (73%) patients in the umifenovir group tested negative for SARS-CoV-2 within 7 days after admission, the number was 28/36 (78%) in the control group (p 0.19). The median time from onset of symptoms to SARS-CoV-2 turning negative was 18 days (interquartile range (IQR) 12-21) in the umifenovir group and 16 days (IQR 11-21) in the control group (p 0.42). Patients in the umifenovir group had a longer hospital stay than patients in the control group (13 days (IQR 9-17) vs 11 days (IQR 9-14), p 0.04). No deaths or severe adverse reactions were found in both groups. DISCUSSION Umifenovir might not improve the prognosis or accelerate SARS-CoV-2 clearance in non-ICU patients. A randomized control clinical trial is needed to assess the efficacy of umifenovir.",2020,"CONCLUSIONS Umifenovir might not improve the prognosis or accelerate the SARS-CoV-2 clearance in non-ICU patients.","['81 COVID-19 patients were included, with 45 in umifenovir group and 36 in control group', 'non-ICU Ward in Jinyintan Hospital from February 2, 2020 to March 20, 2020', 'patients with coronavirus disease 2019']","['umifenovir', 'Umifenovir treatment', 'Umifenovir (Arbidol®']","['deaths or severe adverse reaction', 'SARS-CoV-2 clearance', 'median time from onset of symtoms to SARS-CoV-2 turning negative', ""negative rate of pharyngeal swab's test for SARS-CoV-2 within 1\xa0week after admission, as well as the duration for virus turning negative"", 'negativity time of SARS-CoV-2', 'longer hospital stay', 'SARS-CoV-2']","[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0254211', 'cui_str': 'umifenovir'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}]","[{'cui': 'C0254211', 'cui_str': 'umifenovir'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332162', 'cui_str': 'Onset of'}, {'cui': 'C0541749', 'cui_str': 'Does turn'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0439056', 'cui_str': 'Throat swab'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1442452', 'cui_str': 'One week'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0042769', 'cui_str': 'Viral disease'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}]",81.0,0.0490309,"CONCLUSIONS Umifenovir might not improve the prognosis or accelerate the SARS-CoV-2 clearance in non-ICU patients.","[{'ForeName': 'N', 'Initials': 'N', 'LastName': 'Lian', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, The First Affiliated Hospital of Fujian Medical University, Fuzhou, China.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Xie', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, The First Affiliated Hospital of Fujian Medical University, Fuzhou, China.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Lin', 'Affiliation': 'Liver Research Centre, The First Affiliated Hospital of Fujian Medical University, Fuzhou, China.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Huang', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, The First Affiliated Hospital of Fujian Medical University, Fuzhou, China.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Zhao', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, The First Affiliated Hospital of Fujian Medical University, Fuzhou, China.'}, {'ForeName': 'Q', 'Initials': 'Q', 'LastName': 'Lin', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, The First Affiliated Hospital of Fujian Medical University, Fuzhou, China. Electronic address: linqc_fy@126.com.'}]",Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases,['10.1016/j.cmi.2020.04.026'] 26,32348700,Economic evaluation of a combined screening and stepped-care treatment program targeting psychological distress in patients with metastatic colorectal cancer: A cluster randomized controlled trial.,"BACKGROUND Psychological distress is highly prevalent among patients with metastatic colorectal cancer. AIMS To perform an economic evaluation of a combined screening and treatment program targeting psychological distress in patients with metastatic colorectal cancer in comparison with usual care. DESIGN Societal costs were collected alongside a cluster randomized controlled trial for 48 weeks. A total of 349 participants were included. SETTING Participants were recruited from oncology departments at 16 participating hospitals in the Netherlands. METHODS Outcome measures were the Hospital Anxiety and Depression Scale and quality-adjusted life-years. Missing data were imputed using multiple imputation. Uncertainty was estimated using bootstrapping. Cost-effectiveness planes and cost-effectiveness acceptability curves were estimated to show uncertainty surrounding the cost-effectiveness estimates. Sensitivity analyses were performed to check robustness of results. RESULTS Between treatment arms, no significant differences were found in Hospital Anxiety and Depression Scale score (mean difference: -0.058; 95% confidence interval: -0.13 to 0.011), quality-adjusted life-years (mean difference: 0.042; 95% confidence interval: -0.015 to 0.099), and societal costs (mean difference: -1152; 95% confidence interval: -5058 to 2214). Cost-effectiveness acceptability curves showed that the probability of cost-effectiveness was 0.64 and 0.74 at willingness-to-pay values of €0 and €10,000 per point improvement on the Hospital Anxiety and Depression Scale, respectively. The probability that the intervention was cost-effective compared to usual care for quality-adjusted life-years was 0.64 and 0.79 at willingness-to-pay values of €0 and €20,000 per quality-adjusted life-year, respectively. CONCLUSION The intervention is dominant over usual care, primarily due to lower costs in the intervention group. However, there were no statistically significant differences in clinical effects and the uptake of the intervention was quite low. Therefore, widespread implementation cannot be recommended.",2020,"The probability that the intervention was cost-effective compared to usual care for quality-adjusted life-years was 0.64 and 0.79 at willingness-to-pay values of €0 and €20,000 per quality-adjusted life-year, respectively. ","['A total of 349 participants were included', 'patients with metastatic colorectal cancer in comparison with usual care', 'Participants were recruited from oncology departments at 16 participating hospitals in the Netherlands', 'patients with metastatic colorectal cancer']","['combined screening and treatment program targeting psychological distress', 'combined screening and stepped-care treatment program']","['probability of cost-effectiveness', 'Hospital Anxiety and Depression Scale score', 'Hospital Anxiety and Depression Scale and quality-adjusted life-years', 'cost-effective', 'Hospital Anxiety and Depression Scale', 'Cost-effectiveness planes and cost-effectiveness acceptability curves', 'Cost-effectiveness acceptability', 'quality-adjusted life-years', 'societal costs']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4721579', 'cui_str': 'Secondary malignant neoplasm of colon and/or rectum'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0815107', 'cui_str': 'Emotional Distress'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}]","[{'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C3539657', 'cui_str': 'Hospital anxiety and depression scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0205134', 'cui_str': 'Curved'}]",349.0,0.193851,"The probability that the intervention was cost-effective compared to usual care for quality-adjusted life-years was 0.64 and 0.79 at willingness-to-pay values of €0 and €20,000 per quality-adjusted life-year, respectively. ","[{'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'El Alili', 'Affiliation': 'Department of Health Sciences, Faculty of Science, Amsterdam Public Health Research Institute, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Claudia S E W', 'Initials': 'CSEW', 'LastName': 'Schuurhuizen', 'Affiliation': 'Department of Medical Oncology, Amsterdam UMC, Vrije Universtiteit Amsterdam, Cancer Center Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Annemarie M J', 'Initials': 'AMJ', 'LastName': 'Braamse', 'Affiliation': 'Department of Medical Psychology, Amsterdam UMC, Academic Medical Center, Cancer Center Amsterdam, Amsterdam Public Health Research Institute, Amsterdam, The Netherlands.'}, {'ForeName': 'Aartjan T F', 'Initials': 'ATF', 'LastName': 'Beekman', 'Affiliation': 'Department of Psychiatry, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam Public Health Research institute, Amsterdam, The Netherlands.'}, {'ForeName': 'Mecheline H', 'Initials': 'MH', 'LastName': 'van der Linden', 'Affiliation': 'Department of Medical Psychology, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Inge R', 'Initials': 'IR', 'LastName': 'Konings', 'Affiliation': 'Department of Medical Oncology, Amsterdam UMC, Vrije Universtiteit Amsterdam, Cancer Center Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Joost', 'Initials': 'J', 'LastName': 'Dekker', 'Affiliation': 'Department of Psychiatry, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam Public Health Research institute, Amsterdam, The Netherlands.'}, {'ForeName': 'Judith E', 'Initials': 'JE', 'LastName': 'Bosmans', 'Affiliation': 'Department of Health Sciences, Faculty of Science, Amsterdam Public Health Research Institute, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}]",Palliative medicine,['10.1177/0269216320913463'] 27,32348306,Two-year efficacy of varenicline tartrate and counselling for inpatient smoking cessation (STOP study): A randomized controlled clinical trial.,"INTRODUCTION Varenicline tartrate is superior for smoking cessation to other tobacco cessation therapies by 52 weeks, in the outpatient setting. We aimed to evaluate the long-term (104 week) efficacy following a standard course of inpatient-initiated varenicline tartrate plus Quitline-counselling compared to Quitline-counselling alone. METHODS Adult patients (n = 392, 20-75 years) admitted with a smoking-related illnesses to one of three hospitals, were randomised to receive either 12-weeks of varenicline tartrate (titrated from 0.5mg daily to 1mg twice-daily) plus Quitline-counselling, (n = 196) or Quitline-counselling alone, (n = 196), with continuous abstinence from smoking assessed at 104 weeks. RESULTS A total of 1959 potential participants were screened for eligibility between August 2008 and December 2011. The proportion of participants who remained continuously abstinent (intention-to-treat) at 104 weeks were significantly greater in the varenicline tartrate plus counselling arm (29.2% n = 56) compared to counselling alone (18.8% n = 36; p = 0.02; odds ratio 1.78; 95%CI 1.10 to 2.86, p = 0.02). Twenty-two deaths occurred during the 104 week study (n = 10 for varenicline tartrate plus counselling and n = 12 for Quitline-counselling alone). All of these participants had known or developed underlying co-morbidities. CONCLUSIONS This is the first study to examine the efficacy and safety of varenicline tartrate over 104 weeks within any setting. Varenicline tartrate plus Quitline-counselling was found to be an effective opportunistic treatment when initiated for inpatient smokers who had been admitted with tobacco-related disease.",2020,"INTRODUCTION Varenicline tartrate is superior for smoking cessation to other tobacco cessation therapies by 52 weeks, in the outpatient setting.","['A total of 1959 potential participants were screened for eligibility between August 2008 and December 2011', 'inpatient smoking cessation (STOP study', 'inpatient smokers who had been admitted with tobacco-related disease', 'Adult patients (n = 392, 20-75 years) admitted with a smoking-related illnesses to one of three hospitals']","['varenicline tartrate plus Quitline-counselling compared to Quitline-counselling alone', 'varenicline tartrate', 'Varenicline tartrate plus Quitline-counselling', 'varenicline tartrate plus counselling', 'Quitline-counselling alone', 'varenicline tartrate and counselling', 'Varenicline tartrate', 'varenicline tartrate (titrated from 0.5mg daily to 1mg twice-daily) plus Quitline-counselling']",['efficacy and safety'],"[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0450446', 'cui_str': 'Stops'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0040329', 'cui_str': 'Tobacco'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C1711887', 'cui_str': 'Varenicline tartrate'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.0708476,"INTRODUCTION Varenicline tartrate is superior for smoking cessation to other tobacco cessation therapies by 52 weeks, in the outpatient setting.","[{'ForeName': 'Kristin V', 'Initials': 'KV', 'LastName': 'Carson-Chahhoud', 'Affiliation': 'Australian Centre for Precision Health, School of Health Sciences, The University of South Australia, Adelaide, South Australia, Australia.'}, {'ForeName': 'Brian J', 'Initials': 'BJ', 'LastName': 'Smith', 'Affiliation': 'School of Medicine, The University of Adelaide, Adelaide, South Australia, Australia.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Peters', 'Affiliation': 'Thoracic Medicine, Concord Repatriation General Hospital, Sydney, New South Wales, Australia.'}, {'ForeName': 'Malcolm P', 'Initials': 'MP', 'LastName': 'Brinn', 'Affiliation': 'Australian Centre for Precision Health, School of Health Sciences, The University of South Australia, Adelaide, South Australia, Australia.'}, {'ForeName': 'Faisal', 'Initials': 'F', 'LastName': 'Ameer', 'Affiliation': 'Respiratory Medicine, Ipswich Hospital, Ipswich, Queensland, Australia.'}, {'ForeName': 'Kuljit', 'Initials': 'K', 'LastName': 'Singh', 'Affiliation': 'School of Medicine, The University of Adelaide, Adelaide, South Australia, Australia.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Fitridge', 'Affiliation': 'Division of Surgery, The Queen Elizabeth Hospital, Adelaide, South Australia, Australia.'}, {'ForeName': 'Simon A', 'Initials': 'SA', 'LastName': 'Koblar', 'Affiliation': 'Stroke Research Programme, University of Adelaide, Adelaide, South Australia, Australia.'}, {'ForeName': 'Jim', 'Initials': 'J', 'LastName': 'Jannes', 'Affiliation': 'Stroke Research Programme, University of Adelaide, Adelaide, South Australia, Australia.'}, {'ForeName': 'Antony J', 'Initials': 'AJ', 'LastName': 'Veale', 'Affiliation': 'Respiratory Medicine Department, The Queen Elizabeth Hospital, Adelaide, South Australia, Australia.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Goldsworthy', 'Affiliation': 'Pharmacy Department, The Queen Elizabeth Hospital, Adelaide, South Australia, Australia.'}, {'ForeName': 'Khin', 'Initials': 'K', 'LastName': 'Hnin', 'Affiliation': 'Department of Respiratory and Sleep Medicine, Flinders Medical Centre, Adelaide, South Australia, Australia.'}, {'ForeName': 'Adrian J', 'Initials': 'AJ', 'LastName': 'Esterman', 'Affiliation': 'School of Nursing and Midwifery, The University of South Australia, Adelaide, South Australia, Australia.'}]",PloS one,['10.1371/journal.pone.0231095'] 28,32348359,"Predictive validity in middle childhood of short tests of early childhood development used in large scale studies compared to the Bayley-III, the Family Care Indicators, height-for-age, and stunting: A longitudinal study in Bogota, Colombia.","There is increasing global commitment to establish early childhood interventions that promote the development of the millions of disadvantaged children in low- and middle-income countries not reaching their developmental potential. However, progress is hindered by the lack of valid developmental tests feasible for use at large scale. Consequently, there is an urgent need for such tests. Whilst screeners and single-domain tests ('short tests') are used as alternatives, their predictive validity in these circumstances is unknown. A longitudinal study in Bogota, Colombia began in 2011 when 1,311 children ages 6-42 months were given the Bayley Scales of Infant and Toddler Development (Bayley-III) by psychologists and randomized to receive one of two batteries of short tests under survey conditions. Concurrent validity of the short tests with the Bayley-III ('gold standard') was reported. In 2016, at 6-8 years, 940 of these children were given tests of IQ (Wechsler Intelligence Scale for Children, WISC-V) and school achievement (arithmetic, reading, and vocabulary) by psychologists. We compared the ability of the short tests, the Family Care Indicators (FCI), height-for-age, stunting (median height-for-age <-2 SD), and the Bayley-III to predict IQ and achievement in middle childhood. Predictive validity increased with age for all tests, and cognition and language were usually the highest scales. At 6-18 months, all tests had trivial predictive ability. Thereafter, the Bayley-III had the highest predictive validity, but the Denver Developmental Screening Test was the most feasible and valid short test and could be used with little validity loss compared with the Bayley-III. The MacArthur-Bates Communicative Development Inventory at 19-30 months and the FCI under 31 months predicted IQ and school achievement as well as the Bayley-III. The FCI had higher predictive validity than stunting and height-for-age, and could be added to stunting for use as a population-based indicator of child development.",2020,"The FCI had higher predictive validity than stunting and height-for-age, and could be added to stunting for use as a population-based indicator of child development.","['Bogota, Colombia began in 2011 when 1,311 children ages 6-42 months were given the Bayley Scales of Infant and Toddler Development']",[],"['trivial predictive ability', 'IQ (Wechsler Intelligence Scale for Children, WISC-V) and school achievement (arithmetic, reading, and vocabulary', 'Predictive validity']","[{'cui': 'C3245499', 'cui_str': 'Colombia'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0682053', 'cui_str': 'Toddler'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}]",[],"[{'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0204457', 'cui_str': 'Wechsler intelligence scale for children'}, {'cui': 'C0700132', 'cui_str': 'Academic Achievement'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0042283', 'cui_str': 'Validity (Epidemiology)'}]",1311.0,0.0200179,"The FCI had higher predictive validity than stunting and height-for-age, and could be added to stunting for use as a population-based indicator of child development.","[{'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Rubio-Codina', 'Affiliation': 'Social Protection and Health Division, Inter-American Development Bank, Washington, D.C., United States of America.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Grantham-McGregor', 'Affiliation': 'Faculty of Population Health Sciences, Institute of Child Health, University College London, London, United Kingdom.'}]",PloS one,['10.1371/journal.pone.0231317'] 29,32352368,"Determination of thiorphan, a racecadotril metabolite, in human plasma by LC-MS/MS and its application to a bioequivalence study in Chinese subjects
.","OBJECTIVE The objective of this study was to use LC-MS/MS to compare the pharmacodynamic properties and bioequivalence of two 200-mg formulations of racecadotril: suspension formulation (test) and granule formulation (reference) in healthy Chinese subjects. MATERIALS AND METHODS A single-dose, randomized, two-period crossover study was conducted in fasted healthy Chinese subjects, who received a single oral dose of the test or reference formulation, followed by a 7-day washout period and administration of the alternate formulation. RESULTS The rapid and highly sensitive LC-MS/MS method exhibited a reasonable linearity range (2.324 - 952.000 ng/mL) and high sensitivity (LLOQ of 2.324 ng/mL). The within- and between-run precision, accuracy, and stability results were within the acceptable limits, and no matrix effect was observed. The 90% CI of the ratio of geometric means for AUC 0-t , AUC 0-∞ , and C max were 88.1 - 102.3%, 87.9 - 101.5% and 99.5 - 113%, respectively, which met the regulatory criteria for bioequivalence. CONCLUSION The method is suitable for quantification of thiorphan in human plasma. In addition, the results indicated that the test and reference formulations were bioequivalent in terms of both rate and extent of absorption.",2020,"The within- and between-run precision, accuracy, and stability results were within the acceptable limits, and no matrix effect was observed.","['Chinese subjects\u2029', 'fasted healthy Chinese subjects', 'healthy Chinese subjects']",['racecadotril: suspension formulation (test) and granule formulation (reference'],"['ratio of geometric means for AUC 0-t , AUC 0-∞ , and C max']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}]","[{'cui': 'C0050461', 'cui_str': 'racecadotril'}, {'cui': 'C0007985', 'cui_str': 'Chemical suspension'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0010837', 'cui_str': 'Cytoplasmic Granules'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}]",,0.0279426,"The within- and between-run precision, accuracy, and stability results were within the acceptable limits, and no matrix effect was observed.","[{'ForeName': 'Lan', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'Chenlin', 'Initials': 'C', 'LastName': 'Shen', 'Affiliation': ''}, {'ForeName': 'Lian', 'Initials': 'L', 'LastName': 'Tang', 'Affiliation': ''}, {'ForeName': 'Yanxia', 'Initials': 'Y', 'LastName': 'Yu', 'Affiliation': ''}, {'ForeName': 'Qin', 'Initials': 'Q', 'LastName': 'Zhou', 'Affiliation': ''}, {'ForeName': 'Xiaohui', 'Initials': 'X', 'LastName': 'Huang', 'Affiliation': ''}, {'ForeName': 'Sudong', 'Initials': 'S', 'LastName': 'Xue', 'Affiliation': ''}]",International journal of clinical pharmacology and therapeutics,['10.5414/CP203588'] 30,32349005,A Randomized Controlled Comparison of Epidural Analgesia Onset Time and Adverse Reactions During Labor With Different Dose Combinations of Bupivacaine and Sufentanil.,"OBJECTIVES The purpose was to compare the effects of 3 different dose combinations of bupivacaine and sufentanil on the onset of analgesia and the occurrence of side effects. MATERIALS AND METHODS One hundred sixty-nine pregnant women were randomly assigned to 3 groups: the B1S5 group received 0.1% bupivacaine+5 μg sufentanil in 15 mL; the B125S5 group received 0.125% bupivacaine+5 μg sufentanil in 15 mL; and the B1S10 group received 0.1% bupivacaine+10 μg sufentanil in 15 mL. The primary outcome was the analgesic onset time, and the secondary outcomes were mode of delivery, patient satisfaction, maternal and neonatal side effects (pruritus, hypotension, sedation, motor block, decreased fetal heart rate, fever, and interference with breastfeeding). RESULTS The median (inter-quartile range) time to achieve effective analgesia was significantly faster in the B125S5 group than in the B1S5 group (10 [11-14 {4-30}] min vs. 15 [17-20 {5-30}] min, P<0.001). There was no significant difference in the analgesia onset time between the B1S10 and B125S5 groups (10 [11-14 {4-30}] min vs. 12 [13-15 {3-30}] min, P=0.202). Pruritus, hypotension, motor block, maternal satisfaction, delivery mode, decreased fetal heart rate, total bupivacaine dose and breastfeeding scores were not significantly different among the 3 groups except the sufentanil dosage and incidence of mild drowsiness and fever (the B1S10 group had significantly higher fever than the other groups). DISCUSSION The B125S5 combination may be superior to the B1S5 and B1S10 combinations as an initial dose for epidural analgesia to achieve rapid effective analgesia with minimal side effects.",2020,"There was no significant difference in the analgesia onset time between the B1S10 and B125S5 groups (10 (11-14 [4-30]) min vs. 12 (13-15 [3-30]) min, P=0.202).",['One hundred sixty-nine pregnant women'],"['Bupivacaine and Sufentanil', 'B1S10 group received 0.1% bupivacaine + 10▒μg sufentanil', 'B1S5 group received 0.1% bupivacaine + 5▒μg sufentanil', 'B125S5 group received 0.125% bupivacaine + 5▒μg sufentanil', 'bupivacaine and sufentanil']","['mild drowsiness and fever', 'analgesic onset time, and the secondary outcomes were mode of delivery, patient satisfaction, maternal and neonatal side effects (pruritus, hypotension, sedation, motor block, decreased fetal heart rate, fever and breast feeding', 'Epidural Analgesia Onset Time and Adverse Reactions', 'Pruritus, hypotension, motor block, maternal satisfaction, delivery mode, decreased fetal heart rate, total bupivacaine dose and breastfeeding scores', 'median (IQR [range]) time to achieve effective analgesia', 'analgesia onset time']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0450388', 'cui_str': '69'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}]","[{'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0143993', 'cui_str': 'Sufentanil'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517420', 'cui_str': '0.1'}, {'cui': 'C4517427', 'cui_str': '0.125'}]","[{'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0449244', 'cui_str': 'Time of onset'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0018811', 'cui_str': 'Fetal heart rate'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0002769', 'cui_str': 'Epidural analgesia'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}]",169.0,0.114634,"There was no significant difference in the analgesia onset time between the B1S10 and B125S5 groups (10 (11-14 [4-30]) min vs. 12 (13-15 [3-30]) min, P=0.202).","[{'ForeName': 'Tingting', 'Initials': 'T', 'LastName': 'Wang', 'Affiliation': 'Department of Anaesthesia, Obstetrics and Gynecology Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Yaojun', 'Initials': 'Y', 'LastName': 'Lu', 'Affiliation': 'Department of Anaesthesia, Obstetrics and Gynecology Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Peiwen', 'Initials': 'P', 'LastName': 'Zhou', 'Affiliation': 'Department of Anaesthesia, Obstetrics and Gynecology Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Shaoqiang', 'Initials': 'S', 'LastName': 'Huang', 'Affiliation': 'Department of Anaesthesia, Obstetrics and Gynecology Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Xinhua', 'Initials': 'X', 'LastName': 'Yu', 'Affiliation': 'Division of Epidemiology, Biostatistics, and Environmental Health, School of Public Health, University of Memphis, Memphis, TN.'}]",The Clinical journal of pain,['10.1097/AJP.0000000000000837'] 31,32350413,Scheduling nab-paclitaxel combined with gemcitabine as first-line treatment for metastatic pancreatic adenocarcinoma.,"BACKGROUND Nab-paclitaxel plus gemcitabine (nabP+gemcitabine) offers modest survival gains for patients with metastatic pancreatic ductal adenocarcinoma (PDAC). Sequential scheduling of nabP+gemcitabine in a PDAC mouse model improved efficacy; this hypothesis was tested in a clinical trial. METHODS Patients with previously untreated metastatic PDAC were randomised to receive nabP+gemcitabine administered either concomitantly on the same day, or sequentially, with gemcitabine administered 24 h after nabP. The primary outcome measure was progression-free survival (PFS). Secondary outcome measures were objective response rate (ORR), overall survival (OS), safety, quality of life (QoL) and predictive biomarkers. RESULTS In total, 71 patients received sequential (SEQ) and 75 concomitant (CON) treatment. Six-month PFS was 46% with SEQ and 32% with CON scheduling. Median PFS (5.6 versus 4.0 months, hazard ratio [HR] 0.67, 95% confidence interval [95% CI] 0.47-0.95, p = 0.022) and ORR (52% versus 31%, p = 0.023) favoured the SEQ arm; median OS was 10.2 versus 8.2 months (HR 0.93, 95% CI 0.65-1.33, p = 0.70). CTCAE Grade ≥3 neutropaenia incidence doubled with SEQ therapy but was not detrimental to QoL. Strongly positive tumour epithelial cytidine deaminase (CDA) expression favoured benefit from SEQ therapy (PFS HR 0.31, 95% CI 0.13-0.70). CONCLUSIONS SEQ delivery of nabP+gemcitabine improved PFS and ORR, with manageable toxicity, but did not significantly improve OS. CLINICAL TRIAL REGISTRATION ISRCTN71070888; ClinialTrials.gov (NCT03529175).",2020,"Median PFS (5.6 versus 4.0 months, hazard ratio [HR] 0.67, 95% confidence interval [95% CI] 0.47-0.95, p = 0.022) and ORR (52% versus 31%, p = 0.023) favoured the SEQ arm; median OS was 10.2 versus 8.2 months (HR 0.93, 95% CI 0.65-1.33,","['Patients with previously untreated metastatic PDAC', 'metastatic pancreatic adenocarcinoma', 'patients with metastatic pancreatic ductal adenocarcinoma (PDAC']","['nabP+gemcitabine', 'sequential (SEQ) and 75 concomitant (CON) treatment', 'Scheduling nab-paclitaxel combined with gemcitabine', 'paclitaxel plus gemcitabine (nabP+gemcitabine', 'gemcitabine']","['Median PFS', 'OS', 'CTCAE Grade ≥3 neutropaenia incidence', 'objective response rate (ORR), overall survival (OS), safety, quality of life (QoL) and predictive biomarkers', 'survival gains', 'ORR', 'SEQ arm; median OS', 'efficacy', 'PFS and ORR, with manageable toxicity', 'progression-free survival (PFS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C1335302', 'cui_str': 'Ductal adenocarcinoma of pancreas'}, {'cui': 'C0861727', 'cui_str': 'Pancreatic adenocarcinoma metastatic'}]","[{'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205539', 'cui_str': 'Scheduled - procedure status'}, {'cui': 'C1527223', 'cui_str': '130-nm albumin-bound paclitaxel'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C1516728', 'cui_str': 'National Cancer Institute common terminology criteria for adverse events'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0040539', 'cui_str': 'TO'}]",,0.254728,"Median PFS (5.6 versus 4.0 months, hazard ratio [HR] 0.67, 95% confidence interval [95% CI] 0.47-0.95, p = 0.022) and ORR (52% versus 31%, p = 0.023) favoured the SEQ arm; median OS was 10.2 versus 8.2 months (HR 0.93, 95% CI 0.65-1.33,","[{'ForeName': 'P G', 'Initials': 'PG', 'LastName': 'Corrie', 'Affiliation': ""Cambridge University Hospitals NHS Foundation Trust (Addenbrooke's Hospital), Cambridge, UK. pippa.corrie@addenbrookes.nhs.uk.""}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Qian', 'Affiliation': ""Cambridge University Hospitals NHS Foundation Trust (Addenbrooke's Hospital), Cambridge, UK.""}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Basu', 'Affiliation': ""Cambridge University Hospitals NHS Foundation Trust (Addenbrooke's Hospital), Cambridge, UK.""}, {'ForeName': 'J W', 'Initials': 'JW', 'LastName': 'Valle', 'Affiliation': 'University of Manchester and The Christie NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Falk', 'Affiliation': 'Bristol Haematology and Oncology Centre, Bristol, UK.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Lwuji', 'Affiliation': 'Leicester Royal Infirmary, Leicester, UK.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Wasan', 'Affiliation': 'Hammersmith Hospital, Imperial College, London, UK.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Palmer', 'Affiliation': 'Clatterbridge Cancer Centre, Liverpool, UK.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Scott-Brown', 'Affiliation': 'University Hospital Coventry and Warwickshire, Coventry, UK.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Wadsley', 'Affiliation': 'Weston Park Hospital, Sheffield, UK.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Arif', 'Affiliation': 'Velindre Cancer Centre, Cardiff, UK.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Bridgewater', 'Affiliation': 'UCL Cancer Institute, London, UK.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Propper', 'Affiliation': 'Barts Cancer Institute, London, UK.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Gillmore', 'Affiliation': 'The Royal Free Hospital, London, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Gopinathan', 'Affiliation': 'Cancer Research UK-Cambridge Institute, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Skells', 'Affiliation': ""Cambridge University Hospitals NHS Foundation Trust (Addenbrooke's Hospital), Cambridge, UK.""}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Bundi', 'Affiliation': ""Cambridge University Hospitals NHS Foundation Trust (Addenbrooke's Hospital), Cambridge, UK.""}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Brais', 'Affiliation': ""Cambridge University Hospitals NHS Foundation Trust (Addenbrooke's Hospital), Cambridge, UK.""}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Dalchau', 'Affiliation': ""Cambridge University Hospitals NHS Foundation Trust (Addenbrooke's Hospital), Cambridge, UK.""}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Bax', 'Affiliation': ""Cambridge University Hospitals NHS Foundation Trust (Addenbrooke's Hospital), Cambridge, UK.""}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Chhabra', 'Affiliation': ""Cambridge University Hospitals NHS Foundation Trust (Addenbrooke's Hospital), Cambridge, UK.""}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Machin', 'Affiliation': ""Cambridge University Hospitals NHS Foundation Trust (Addenbrooke's Hospital), Cambridge, UK.""}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Dayim', 'Affiliation': ""Cambridge University Hospitals NHS Foundation Trust (Addenbrooke's Hospital), Cambridge, UK.""}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'McAdam', 'Affiliation': 'Peterborough City Hospital, Peterborough, UK.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Cummins', 'Affiliation': 'Royal Surrey County Hospital, Guildford, UK.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Wall', 'Affiliation': 'Western General Hospital, Edinburgh, UK.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Ellis', 'Affiliation': 'Royal Cornwall Hospitals, Truro, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Anthoney', 'Affiliation': ""St. James's University Hospitals, Leeds, UK.""}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Evans', 'Affiliation': 'Beatson West of Scotland Cancer Centre, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Y T', 'Initials': 'YT', 'LastName': 'Ma', 'Affiliation': 'Queen Elizabeth Hospital, Birmingham, UK.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Isherwood', 'Affiliation': 'Cancer Research UK-Cambridge Institute, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Neesse', 'Affiliation': 'Gastroenterology and Gastrointestinal Cancer Clinic, University of Göttingen, Göttingen, Germany.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Tuveson', 'Affiliation': 'Cold Spring Harbor Laboratory, Cold Spring Harbor, New York, USA.'}, {'ForeName': 'D I', 'Initials': 'DI', 'LastName': 'Jodrell', 'Affiliation': ""Cambridge University Hospitals NHS Foundation Trust (Addenbrooke's Hospital), Cambridge, UK.""}]",British journal of cancer,['10.1038/s41416-020-0846-2'] 32,32349117,One-day tropisetron treatment improves cognitive deficits and P50 inhibition deficits in schizophrenia.,"The core features of schizophrenia (SCZ) include cognitive deficits and impaired sensory gating represented by P50 inhibition deficits, which appear to be related to the α7 nicotinic acetylcholine receptor (nAChR). An agonist of nAChR receptor may improve these defects. This study aimed to investigate how administering multiple doses of tropisetron, a partial agonist of nAChR, for 1 day would affect cognitive deficits and P50 inhibition deficits in SCZ patients. We randomized 40 SCZ non-smokers into a double-blind clinical trial with four groups: placebo, 5 mg/d, 10 mg/d, and 20 mg/d of oral tropisetron. Their P50 ratios were all more than 0.5 and they took risperidone at 3-6 mg/day for at least a month before participating in the experiment. We measured the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) and P50 inhibition before and one day after treatment. After one day of treatment, the total RBANS scores of the 20 mg and 5 mg tropisetron groups, and the immediate memory of the 10 mg group were significantly higher than placebo group. The P50 ratio was smaller in the 5 mg and 10 mg groups than in the placebo group (both p < 0.05) after treatment. Furthermore, the improvement in RBANS total score was correlated with increased S1 latency (p < 0.05), and the increase in immediate memory score was correlated with decreased S2 amplitude. One day of treatment with tropisetron improved both cognitive and P50 inhibition deficits, suggesting that longer term treatment with α7 nAChR agonists for these deficits in SCZ may be promising.",2020,"Furthermore, the improvement in RBANS total score was correlated with increased S1 latency (p < 0.05), and the increase in immediate memory score was correlated with decreased S2 amplitude.","['schizophrenia', 'SCZ patients']","['tropisetron', 'risperidone', 'oral tropisetron', 'placebo']","['S1 latency', 'P50 ratio', 'total RBANS scores', 'cognitive and P50 inhibition deficits', 'immediate memory score', 'P50 ratios', 'Neuropsychological Status (RBANS) and P50 inhibition', 'cognitive deficits and P50 inhibition deficits', 'RBANS total score']","[{'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0063322', 'cui_str': 'tropisetron'}, {'cui': 'C0073393', 'cui_str': 'Risperidone'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0242465', 'cui_str': 'Response Latency'}, {'cui': 'C0219874', 'cui_str': 'p50(csk)'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C2959617', 'cui_str': 'Repeatable battery for the assessment of neuropsychological status score'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C4505412', 'cui_str': 'Repeatable Battery for the Assessment of Neuropsychological Status'}, {'cui': 'C0009241', 'cui_str': 'Cognitive disorder'}]",40.0,0.0632082,"Furthermore, the improvement in RBANS total score was correlated with increased S1 latency (p < 0.05), and the increase in immediate memory score was correlated with decreased S2 amplitude.","[{'ForeName': 'Luyao', 'Initials': 'L', 'LastName': 'Xia', 'Affiliation': 'Institute of Psychology, Chinese Academy of Sciences, Beijing, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Mental Health Center, Shantou University, Shantou, China.'}, {'ForeName': 'Xiaohong', 'Initials': 'X', 'LastName': 'Hong', 'Affiliation': 'Mental Health Center, Shantou University, Shantou, China.'}, {'ForeName': 'Dongmei', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': 'Institute of Psychology, Chinese Academy of Sciences, Beijing, China.'}, {'ForeName': 'Gaoxia', 'Initials': 'G', 'LastName': 'Wei', 'Affiliation': 'Institute of Psychology, Chinese Academy of Sciences, Beijing, China.'}, {'ForeName': 'Jiesi', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Institute of Psychology, Chinese Academy of Sciences, Beijing, China.'}, {'ForeName': 'Huixia', 'Initials': 'H', 'LastName': 'Zhou', 'Affiliation': 'Institute of Psychology, Chinese Academy of Sciences, Beijing, China.'}, {'ForeName': 'Hang', 'Initials': 'H', 'LastName': 'Xu', 'Affiliation': 'Institute of Psychology, Chinese Academy of Sciences, Beijing, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Tian', 'Affiliation': 'Institute of Psychology, Chinese Academy of Sciences, Beijing, China.'}, {'ForeName': 'Qilong', 'Initials': 'Q', 'LastName': 'Dai', 'Affiliation': 'Institute of Psychology, Chinese Academy of Sciences, Beijing, China.'}, {'ForeName': 'Hanjing E', 'Initials': 'HE', 'LastName': 'Wu', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, The University of Texas Health Science Center at Houston, Houston, TX, USA.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Chang', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, The University of Texas Health Science Center at Houston, Houston, TX, USA.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Institute of Psychology, Chinese Academy of Sciences, Beijing, China.'}, {'ForeName': 'Thomas R', 'Initials': 'TR', 'LastName': 'Kosten', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Baylor College of Medicine, Houston, TX, USA.'}, {'ForeName': 'Xiang Yang', 'Initials': 'XY', 'LastName': 'Zhang', 'Affiliation': 'Institute of Psychology, Chinese Academy of Sciences, Beijing, China. zhangxy@psych.ac.cn.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-020-0685-0'] 33,32349752,The use of a task through virtual reality in cerebral palsy using two different interaction devices (concrete and abstract) - a cross-sectional randomized study.,"BACKGROUND Cerebral Palsy (CP) is characterised by variable difficulties in muscular action, resulting in inability of the individual to perform functional movement. An option to provide functionality to the individual with CP is the use of computer innovation. The aim of this paper was to verify if there was any performance improvement in a task performed in a virtual environment and if there was transfer to the task performed in the real environment and vice versa in this population. METHODS A computer program was developed comprising a motor task, but with two possibilities of user interaction: a) concrete interface (with physical contact): in which the individual touches the computer screen to finish the task and b) abstract interface (no physical contact): in which the individual performs a hand movement in front of the Kinect device. Participants were split into two groups. The experimental group consisted of 28 individuals with CP within the ages of 6 and 15 years old. The control group included 28 typically developing individuals mirroring the age and sex of the experimental group. RESULTS Individuals from both groups were able to improve task performance and retain acquired information. The CP group presented worse performance than the control group in all phases of the study. Further findings showed that the CP group presented better performance in the abstract interface than in the concrete interface, whereas, in the control group, the opposite occurred: their best performance was in the concrete. CONCLUSIONS Motor tasks performed by individuals with CP through an interface with a more virtual environment feature (abstract interface: Kinect) provided better performance when compared to an interface with a more real characteristic (concrete interface: Touchscreen). TRIAL REGISTRATION ClinicalTrials.gov Identifier - NCT03352440; Date of registration - November 17, 2017.",2020,The CP group presented worse performance than the control group in all phases of the study.,"['28 individuals with CP within the ages of 6 and 15\u2009years old', '28 typically developing individuals mirroring the age and sex of the experimental group']",['CP'],['task performance and retain acquired information'],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0007789', 'cui_str': 'Cerebral palsy'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0181868', 'cui_str': 'Mirror'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0007789', 'cui_str': 'Cerebral palsy'}]","[{'cui': 'C0039333', 'cui_str': 'Task Performance'}, {'cui': 'C0333118', 'cui_str': 'Retained'}, {'cui': 'C0439661', 'cui_str': 'Acquired'}]",28.0,0.0258486,The CP group presented worse performance than the control group in all phases of the study.,"[{'ForeName': 'Andréa Fernanda', 'Initials': 'AF', 'LastName': 'Leal', 'Affiliation': 'Laboratório de Desenho e Escrita Científica, Departamento de Ciências Básicas, Faculdade de Medicina do ABC, Santo André, SP, Brazil.'}, {'ForeName': 'Talita Dias', 'Initials': 'TD', 'LastName': 'da Silva', 'Affiliation': 'Departamento de Cardiologia, Escola Paulista de Medicina, Universidade Federal de São Paulo, São Paulo, SP, Brazil. ft.talitadias@gmail.com.'}, {'ForeName': 'Priscila Bianchi', 'Initials': 'PB', 'LastName': 'Lopes', 'Affiliation': 'Departamento de Cardiologia, Escola Paulista de Medicina, Universidade Federal de São Paulo, São Paulo, SP, Brazil.'}, {'ForeName': 'Shayan', 'Initials': 'S', 'LastName': 'Bahadori', 'Affiliation': 'Orthopaedic Research Institute, Bournemouth University, Executive Business Centre, Holdenhurst Road, Bournemouth, BH8 8EB, UK.'}, {'ForeName': 'Luciano Vieira', 'Initials': 'LV', 'LastName': 'de Araújo', 'Affiliation': 'Grupo de Pesquisa e Aplicações Tecnológicas em Reabilitação, Escola de Artes, Ciências e Humanidades - EACH - Universidade de São Paulo, São Paulo, SP, Brazil.'}, {'ForeName': 'Murillo Vinicius Brandão', 'Initials': 'MVB', 'LastName': 'da Costa', 'Affiliation': 'Grupo de Pesquisa e Aplicações Tecnológicas em Reabilitação, Escola de Artes, Ciências e Humanidades - EACH - Universidade de São Paulo, São Paulo, SP, Brazil.'}, {'ForeName': 'Íbis Ariana Peña', 'Initials': 'ÍAP', 'LastName': 'de Moraes', 'Affiliation': 'Grupo de Pesquisa e Aplicações Tecnológicas em Reabilitação, Escola de Artes, Ciências e Humanidades - EACH - Universidade de São Paulo, São Paulo, SP, Brazil.'}, {'ForeName': 'Ricardo Henrique', 'Initials': 'RH', 'LastName': 'Marques', 'Affiliation': 'Programa de Pós-Graduação em Bioengenharia, Universidade Brasil, São Paulo, SP, Brazil.'}, {'ForeName': 'Tania Brusque', 'Initials': 'TB', 'LastName': 'Crocetta', 'Affiliation': 'Grupo de Pesquisa e Aplicações Tecnológicas em Reabilitação, Escola de Artes, Ciências e Humanidades - EACH - Universidade de São Paulo, São Paulo, SP, Brazil.'}, {'ForeName': 'Luiz Carlos', 'Initials': 'LC', 'LastName': 'de Abreu', 'Affiliation': 'Laboratório de Desenho e Escrita Científica, Departamento de Ciências Básicas, Faculdade de Medicina do ABC, Santo André, SP, Brazil.'}, {'ForeName': 'Carlos Bandeira de Mello', 'Initials': 'CBM', 'LastName': 'Monteiro', 'Affiliation': 'Laboratório de Desenho e Escrita Científica, Departamento de Ciências Básicas, Faculdade de Medicina do ABC, Santo André, SP, Brazil.'}]",Journal of neuroengineering and rehabilitation,['10.1186/s12984-020-00689-z'] 34,32349761,Stand Out in Class: restructuring the classroom environment to reduce sitting time - findings from a pilot cluster randomised controlled trial.,"BACKGROUND Excessive sedentary behaviour (sitting) is a risk factor for poor health in children and adults. Incorporating sit-stand desks in the classroom environment has been highlighted as a potential strategy to reduce children's sitting time. The primary aim of this study was to examine the feasibility of conducting a cluster randomised controlled trial (RCT) of a sit-stand desk intervention within primary school classrooms. METHODS We conducted a two-armed pilot cluster RCT involving 8 primary schools in Bradford, United Kingdom. Schools were randomised on a 1:1 basis to the intervention or usual practice control arm. All children (aged 9-10 years) in participating classes were eligible to take part. Six sit-stand desks replaced three standard desks (sitting 6 children) in the intervention classrooms for 4.5-months. Teachers were encouraged to use a rotation system to ensure all pupils were exposed to the sit-stand desks for > 1 h/day on average. Trial feasibility outcomes (assessed using quantitative and qualitative measures) included school and participant recruitment and attrition, intervention and outcome measure completion rates, acceptability, and preliminary effectiveness of the intervention for reducing sitting time. A weighted linear regression model compared changes in weekday sitting time (assessed using the activPAL accelerometer) between trial arms. RESULTS School and child recruitment rates were 33% (n = 8) and 75% (n = 176). At follow-up, retention rates were 100% for schools and 97% for children. Outcome measure completion rates ranged from 63 to 97%. A preliminary estimate of intervention effectiveness revealed a mean difference in change in sitting of - 30.6 min/day (95% CI: - 56.42 to - 4.84) in favour of the intervention group, after adjusting for baseline sitting and wear time. Qualitative measures revealed the intervention and evaluation procedures were acceptable to teachers and children, except for some problems with activPAL attachment. CONCLUSION This study provides evidence of the acceptability and feasibility of a sit-stand desk intervention and evaluation methods. Preliminary evidence suggests the intervention showed potential in reducing children's weekday sitting but some adaptations to the desk rotation system are needed to maximize exposure. Lessons learnt from this trial will inform the planning of a definitive trial. TRIAL REGISTRATION ISRCTN12915848 (registered: 09/11/16).",2020,"Qualitative measures revealed the intervention and evaluation procedures were acceptable to teachers and children, except for some problems with activPAL attachment. ","['children and adults', '8 primary schools in Bradford, United Kingdom', 'primary school classrooms', 'All children (aged 9-10\u2009years) in participating classes were eligible to take part']","['sit-stand desk intervention', 'sit-stand desk intervention and evaluation methods']","['weekday sitting time', 'retention rates', 'school and participant recruitment and attrition, intervention and outcome measure completion rates, acceptability, and preliminary effectiveness of the intervention for reducing sitting time']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0033145', 'cui_str': 'Primary school'}, {'cui': 'C0041700', 'cui_str': 'United Kingdom of Great Britain and Northern Ireland'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0456387', 'cui_str': 'Class'}]","[{'cui': 'C0560801', 'cui_str': 'Does stand from sitting'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0025663', 'cui_str': 'Method'}]","[{'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0004277', 'cui_str': 'Dental Attrition'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0439611', 'cui_str': 'Preliminary'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}]",6.0,0.096541,"Qualitative measures revealed the intervention and evaluation procedures were acceptable to teachers and children, except for some problems with activPAL attachment. ","[{'ForeName': 'Stacy A', 'Initials': 'SA', 'LastName': 'Clemes', 'Affiliation': 'National Centre for Sport and Exercise Medicine, School of Sport, Exercise and Health Sciences, Loughborough University, Loughborough, UK. S.A.Clemes@lboro.ac.uk.'}, {'ForeName': 'Daniel D', 'Initials': 'DD', 'LastName': 'Bingham', 'Affiliation': 'Bradford Institute for Health Research, Bradford Teaching Hospitals Foundation Trust, Bradford, UK.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Pearson', 'Affiliation': 'National Centre for Sport and Exercise Medicine, School of Sport, Exercise and Health Sciences, Loughborough University, Loughborough, UK.'}, {'ForeName': 'Yu-Ling', 'Initials': 'YL', 'LastName': 'Chen', 'Affiliation': 'National Centre for Sport and Exercise Medicine, School of Sport, Exercise and Health Sciences, Loughborough University, Loughborough, UK.'}, {'ForeName': 'Charlotte L', 'Initials': 'CL', 'LastName': 'Edwardson', 'Affiliation': 'NIHR Leicester Biomedical Research Centre, Leicester, UK.'}, {'ForeName': 'Rosemary R C', 'Initials': 'RRC', 'LastName': 'McEachan', 'Affiliation': 'Bradford Institute for Health Research, Bradford Teaching Hospitals Foundation Trust, Bradford, UK.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Tolfrey', 'Affiliation': 'National Centre for Sport and Exercise Medicine, School of Sport, Exercise and Health Sciences, Loughborough University, Loughborough, UK.'}, {'ForeName': 'Lorraine', 'Initials': 'L', 'LastName': 'Cale', 'Affiliation': 'National Centre for Sport and Exercise Medicine, School of Sport, Exercise and Health Sciences, Loughborough University, Loughborough, UK.'}, {'ForeName': 'Gerry', 'Initials': 'G', 'LastName': 'Richardson', 'Affiliation': 'Centre for Health Economics, University of York, Heslington, York, UK.'}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Fray', 'Affiliation': 'Loughborough Design School, Loughborough University, Loughborough, UK.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Altunkaya', 'Affiliation': 'Centre for Health Economics, University of York, Heslington, York, UK.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Bandelow', 'Affiliation': 'National Centre for Sport and Exercise Medicine, School of Sport, Exercise and Health Sciences, Loughborough University, Loughborough, UK.'}, {'ForeName': 'Nishal Bhupendra', 'Initials': 'NB', 'LastName': 'Jaicim', 'Affiliation': 'Leicester Clinical Trials Unit, University of Leicester, Leicester, UK.'}, {'ForeName': 'Jo', 'Initials': 'J', 'LastName': 'Salmon', 'Affiliation': 'Institute for Physical Activity and Nutrition, School of Exercise and Nutrition Sciences, Deakin University, Melbourne, Australia.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Dunstan', 'Affiliation': 'Baker Heart and Diabetes Institute, Melbourne, Australia.'}, {'ForeName': 'Sally E', 'Initials': 'SE', 'LastName': 'Barber', 'Affiliation': 'Bradford Institute for Health Research, Bradford Teaching Hospitals Foundation Trust, Bradford, UK.'}]",The international journal of behavioral nutrition and physical activity,['10.1186/s12966-020-00958-z'] 35,32352828,Beyond language: Impacts of shared reading on parenting stress and early parent-child relational health.,"This study examined the interrelated and longitudinal impacts of parent-child shared book reading, parenting stress, and early relational health, as measured by both parental warmth and parent sensitivity, from infancy to toddlerhood. To extend findings from previous studies of collateral effects that have been conducted in parenting interventions, we examined parenting behaviors in a broader context to determine whether shared book reading would confer collateral benefits to the parent and parent-child relationship beyond those expected (i.e., language and literacy). It was hypothesized that positive parent-child interactions, such as shared reading, would have positive impacts on parent outcomes such as parenting stress, parental warmth, and sensitivity. The sample consisted of 293 low-income mothers and their children who participated in a randomized controlled trial. Shared book reading, parenting stress, and parental warmth were assessed when children were 6 and 18 months old. We computed a series of cross-lagged structural equation models to examine longitudinal interrelations among these three factors. Results indicated that shared book reading at 6 months was associated with increases in observed and reported parental warmth and observed sensitivity and decreases in parenting stress at 18 months, controlling for baseline risk factors and treatment group status. These findings suggest that early parent-child book reading can have positive collateral impacts on parents' stress and the parent-child relationship over time. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,"Results indicated that shared book reading at 6 months was associated with increases in observed and reported parental warmth and observed sensitivity and decreases in parenting stress at 18 months, controlling for baseline risk factors and treatment group status.",['293 low-income mothers and their children who participated in a randomized controlled trial'],[],"['Shared book reading, parenting stress, and parental warmth', 'parental warmth and observed sensitivity', 'parenting stress', 'parenting stress and early parent-child relational health']","[{'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]",[],"[{'cui': 'C0006002', 'cui_str': 'Book'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",,0.0423104,"Results indicated that shared book reading at 6 months was associated with increases in observed and reported parental warmth and observed sensitivity and decreases in parenting stress at 18 months, controlling for baseline risk factors and treatment group status.","[{'ForeName': 'Caitlin F', 'Initials': 'CF', 'LastName': 'Canfield', 'Affiliation': 'Department of Pediatrics.'}, {'ForeName': 'Elizabeth B', 'Initials': 'EB', 'LastName': 'Miller', 'Affiliation': 'Department of Applied Psychology.'}, {'ForeName': 'Daniel S', 'Initials': 'DS', 'LastName': 'Shaw', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Morris', 'Affiliation': 'Department of Applied Psychology.'}, {'ForeName': 'Angelica', 'Initials': 'A', 'LastName': 'Alonso', 'Affiliation': 'Department of Pediatrics.'}, {'ForeName': 'Alan L', 'Initials': 'AL', 'LastName': 'Mendelsohn', 'Affiliation': 'Department of Pediatrics.'}]",Developmental psychology,['10.1037/dev0000940'] 36,32358310,"Effects of Training With Free Weights Versus Machines on Muscle Mass, Strength, Free Testosterone, and Free Cortisol Levels.","Schwanbeck, SR, Cornish, SM, Barss, T, and Chilibeck, PD. Effects of training with free weights versus machines on muscle mass, strength, free testosterone, and free cortisol levels. J Strength Cond Res 34(7): 1851-1859, 2020-Free weights offer a more unstable training environment, which enhances muscle recruitment, whereas some machines have the advantage of using a ""cam"" pulley system that better matches strength curves. We compared the effect of training with free weights vs. machines on muscle mass, strength, free testosterone, and free cortisol concentrations. Forty-six subjects (26 women; 22 ± 3 years) were randomized to train using free weights or machines for 8 weeks (with each muscle group trained 2-3/weeks, 3-4 sets of 4-10 repetitions). Muscle thickness and strength were measured at 0 and 8 weeks. Salivary hormone concentrations were assessed before and at the end of workouts at the beginning, midway (4 weeks), and end (8 weeks) of the training intervention. Biceps and quadriceps muscle thickness increased (p < 0.01) with no difference between groups. There was a group × time interaction for machine bench press strength (p = 0.05) with the machine group increasing more than the free-weight group (13.9 vs. 8.6%). Free-weight bench press and squat, and Smith machine squat strength increased in both groups (11-19%; p < 0.01) with no difference between groups. Men in the free-weight group had a greater increase in free testosterone from before to after acute training sessions than men in the machine group and all women (p < 0.01); however, there was no differences between groups in free cortisol response to acute resistance exercise. Training sessions with free weights induced greater increases in free testosterone in men; however, training with free weights or machines resulted in similar increases in muscle mass and strength.",2020,There was a group × time interaction for machine bench press strength (p = 0.05) with the machine group increasing more than the free-weight group (13.9 vs. 8.6%).,['Forty-six subjects (26 women; 22 ± 3 years'],"['J Strength Cond Res XX(X', 'Training With Free Weights Versus Machines']","['Free-weight bench press and squat, and Smith machine squat strength', 'Salivary hormone concentrations', 'Schwanbeck, SR, Cornish, SM, Barss, T, and Chilibeck, PD', 'muscle mass, strength, free testosterone, and free cortisol levels', 'muscle mass and strength', 'free testosterone', 'Muscle Mass, Strength, Free Testosterone, and Free Cortisol Levels', 'Biceps and quadriceps muscle thickness', 'Muscle thickness and strength', 'free cortisol response to acute resistance exercise', 'muscle mass, strength, free testosterone, and free cortisol concentrations', 'time interaction for machine bench press strength']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C1856054', 'cui_str': 'Hutterite cerebroosteonephrodysplasia syndrome'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0336779', 'cui_str': 'Machine'}]","[{'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0454326', 'cui_str': 'Bench press'}, {'cui': 'C0241236', 'cui_str': 'Does squat'}, {'cui': 'C0347795', 'cui_str': ""Reversed Colles' fracture""}, {'cui': 'C0336779', 'cui_str': 'Machine'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0682388', 'cui_str': 'Cornish language'}, {'cui': 'C0240417', 'cui_str': 'Form of muscle'}, {'cui': 'C0202228', 'cui_str': 'Testosterone measurement, unbound'}, {'cui': 'C0236401', 'cui_str': 'Cortisol, free measurement'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0559499', 'cui_str': 'Biceps brachii muscle structure'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}]",46.0,0.0269838,There was a group × time interaction for machine bench press strength (p = 0.05) with the machine group increasing more than the free-weight group (13.9 vs. 8.6%).,"[{'ForeName': 'Shane R', 'Initials': 'SR', 'LastName': 'Schwanbeck', 'Affiliation': 'College of Kinesiology, University of Saskatchewan, Saskatoon, Saskatchewan, Canada.'}, {'ForeName': 'Stephen M', 'Initials': 'SM', 'LastName': 'Cornish', 'Affiliation': 'Faculty of Kinesiology and Recreation Management, University of Manitoba, Winnipeg, Manitoba, Canada.'}, {'ForeName': 'Trevor', 'Initials': 'T', 'LastName': 'Barss', 'Affiliation': 'Faculty of Medicine and Dentistry, Neuroscience and Mental Health Institute, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Philip D', 'Initials': 'PD', 'LastName': 'Chilibeck', 'Affiliation': 'College of Kinesiology, University of Saskatchewan, Saskatoon, Saskatchewan, Canada.'}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000003349'] 37,32242978,Incentive spirometry to prevent acute chest syndrome in adults with sickle cell disease; a randomized controlled trial.,,2020,,['adults with sickle cell disease'],['Incentive spirometry'],[],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0002895', 'cui_str': 'Sickling disorder due to hemoglobin S'}]","[{'cui': 'C0454512', 'cui_str': 'Incentive spirometry'}]",[],,0.151465,,"[{'ForeName': 'Charlotte F J', 'Initials': 'CFJ', 'LastName': 'van Tuijn', 'Affiliation': 'Department of Hematology, Amsterdam University Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'Aafke E', 'Initials': 'AE', 'LastName': 'Gaartman', 'Affiliation': 'Department of Hematology, Amsterdam University Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'Erfan', 'Initials': 'E', 'LastName': 'Nur', 'Affiliation': 'Department of Hematology, Amsterdam University Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'Anita W', 'Initials': 'AW', 'LastName': 'Rijneveld', 'Affiliation': 'Department of Hematology, Erasmus University Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'Bart J', 'Initials': 'BJ', 'LastName': 'Biemond', 'Affiliation': 'Department of Hematology, Amsterdam University Medical Center, Amsterdam, The Netherlands.'}]",American journal of hematology,['10.1002/ajh.25805'] 38,32353277,"Multisystemic therapy versus management as usual in the treatment of adolescent antisocial behaviour (START): 5-year follow-up of a pragmatic, randomised, controlled, superiority trial.","BACKGROUND Multisystemic therapy is a manualised treatment programme for young people aged 11-17 years who exhibit antisocial behaviour. To our knowledge, the Systemic Therapy for At Risk Teens (START) trial is the first large-scale randomised controlled trial of multisystemic therapy in the UK. Previous findings reported to 18 months after baseline (START-I study) did not indicate superiority of multisystemic therapy compared with management as usual. Here, we report outcomes of the trial to 60 months (START-II study). METHODS In this pragmatic, randomised, controlled, superiority trial, young people (aged 11-17 years) with moderate-to-severe antisocial behaviour were recruited from social services, youth offending teams, schools, child and adolescent mental health services, and voluntary services across England, UK. Participants were eligible if they had at least three severity criteria indicating past difficulties across several settings and one of five general inclusion criteria for antisocial behaviour. Eligible families were randomly assigned (1:1), using stochastic minimisation and stratifying for treatment centre, sex, age at enrolment, and age at onset of antisocial behaviour, to management as usual or 3-5 months of multisystemic therapy followed by management as usual. Research assistants and investigators were masked to treatment allocation; the participants could not be masked. For this extension study, the primary outcome was the proportion of participants with offences with convictions in each group at 60 months after randomisation. This study is registered with ISRCTN, ISRCTN77132214, and is closed to accrual. FINDINGS Between Feb 4, 2010, and Sept 1, 2012, 1076 young people and families were assessed for eligibility and 684 were randomly assigned to management as usual (n=342) or multisystemic therapy (n=342). By 60 months' of follow-up, 188 (55%) of 342 people in the multisystemic therapy group had at least one offence with a criminal conviction, compared with 180 (53%) of 341 in the management-as-usual group (odds ratio 1·13, 95% CI 0·82-1·56; p=0·44). INTERPRETATION The results of the 5-year follow-up show no evidence of longer-term superiority for multisystemic therapy compared with management as usual. FUNDING National Institute for Health Research Health Services and Delivery Research programme.",2020,"The results of the 5-year follow-up show no evidence of longer-term superiority for multisystemic therapy compared with management as usual. ","['Participants were eligible if they had at least three severity criteria indicating past difficulties across several settings and one of five general inclusion criteria for antisocial behaviour', 'young people (aged 11-17 years) with moderate-to-severe antisocial behaviour were recruited from social services, youth offending teams, schools, child and adolescent mental health services, and voluntary services across England, UK', '1076 young people and families were assessed for eligibility and 684 were randomly assigned to management as usual (n=342) or', 'young people aged 11-17 years who exhibit antisocial behaviour', 'Eligible families']","['multisystemic therapy', 'multisystemic therapy followed by management as usual', 'Multisystemic therapy']",['proportion of participants with offences with convictions'],"[{'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0233523', 'cui_str': 'Antisocial behavior'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0037441', 'cui_str': 'Social Service'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0025355', 'cui_str': 'Mental health service'}, {'cui': 'C1446401', 'cui_str': 'Voluntary services'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0015272', 'cui_str': 'Exhibits as Topic'}]","[{'cui': 'C3840203', 'cui_str': 'Multisystemic therapy'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]",[],,0.202544,"The results of the 5-year follow-up show no evidence of longer-term superiority for multisystemic therapy compared with management as usual. ","[{'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Fonagy', 'Affiliation': 'Research Department of Clinical, Educational and Health Psychology, University College London, London, UK. Electronic address: p.fonagy@ucl.ac.uk.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Butler', 'Affiliation': 'Research Department of Clinical, Educational and Health Psychology, University College London, London, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Cottrell', 'Affiliation': 'Leeds Institute of Health Sciences, University of Leeds, Leeds, UK.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Scott', 'Affiliation': ""Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Pilling', 'Affiliation': 'Research Department of Clinical, Educational and Health Psychology, University College London, London, UK.'}, {'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Eisler', 'Affiliation': ""Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Fuggle', 'Affiliation': 'Anna Freud National Centre for Children and Families, London, UK.'}, {'ForeName': 'Abdullah', 'Initials': 'A', 'LastName': 'Kraam', 'Affiliation': 'Leeds Institute of Health Sciences, University of Leeds, Leeds, UK; Rotherham Doncaster and South Humber NHS Foundation Trust, Doncaster, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Byford', 'Affiliation': ""Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Wason', 'Affiliation': 'Population Health Sciences Institute, Newcastle University, Newcastle upon Tyne, UK; MRC Biostatistics Unit, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Jonathan A', 'Initials': 'JA', 'LastName': 'Smith', 'Affiliation': 'Department of Psychological Sciences, Birkbeck College, University of London, London, UK.'}, {'ForeName': 'Alisa', 'Initials': 'A', 'LastName': 'Anokhina', 'Affiliation': 'Research Department of Clinical, Educational and Health Psychology, University College London, London, UK.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Ellison', 'Affiliation': 'Research Department of Clinical, Educational and Health Psychology, University College London, London, UK.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Simes', 'Affiliation': 'Research Department of Clinical, Educational and Health Psychology, University College London, London, UK.'}, {'ForeName': 'Poushali', 'Initials': 'P', 'LastName': 'Ganguli', 'Affiliation': ""Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Allison', 'Affiliation': 'Research Department of Clinical, Educational and Health Psychology, University College London, London, UK.'}, {'ForeName': 'Ian M', 'Initials': 'IM', 'LastName': 'Goodyer', 'Affiliation': 'Department of Psychiatry, University of Cambridge, Cambridge, UK.'}]",The lancet. Psychiatry,['10.1016/S2215-0366(20)30131-0'] 39,32359046,Does Unit-Dose Packaging Influence Understanding of Serving Size Information for Cannabis Edibles?,"OBJECTIVE Edible cannabis products have increased in popularity, particularly in jurisdictions that have legalized nonmedical cannabis. Rates of adverse events from cannabis edibles have also increased, in part because of difficulties identifying and titrating tetrahydrocannabinol (THC) levels. The current study tested whether packaging cannabis in separate units enhances consumer understanding of serving sizes. METHOD An experimental task was conducted as part of the 2018 International Cannabis Policy Study online survey. Participants were recruited from the Nielsen Global Insights Consumer Panel. A total of 26,894 participants (61.5% female) ages 16-65 years from Canada and the United States were randomly assigned to view a cannabis brownie packaged according to one of three conditions: (a) multiserving edible (""control condition""), (b) single-serving edible, and (c) single-serving edible packaged separately (""unit-dose packaging""). Participants were asked to identify a standard serving based on information on the product label. Logistic regression was used to test the influence of packaging condition on the likelihood of a correct response, adjusting for key covariates. RESULTS Compared with the multiserving edible control (50.6%), participants were significantly more likely to correctly identify the serving size in the single-serving edible condition (55.3%; adjusted odds ratio = 1.22, CI [1.15, 1.29], p < .001) and the unit-dose packaging condition (54.3%; adjusted odds ratio = 1.17, CI [1.10, 1.24], p < .001). CONCLUSIONS Packaging in which each product unit contained one dose of THC enhanced consumers' ability to identify how much of a product constitutes a standard serving or dose. Packaging products as individual doses eliminates the need for mental math and could reduce the risk of accidental overconsumption of cannabis.",2020,"Compared with the multiserving edible control (50.6%), participants were significantly more likely to correctly identify the serving size in the single-serving edible condition (55.3%; adjusted odds ratio = 1.22, CI [1.15, 1.29], p < .001) and the unit-dose packaging condition (54.3%; adjusted odds ratio = 1.17, CI [1.10, 1.24], p < .001). ","['26,894 participants (61.5% female) ages 16-65 years from Canada and the United States', 'An experimental task was conducted as part of the 2018 International Cannabis Policy Study online survey', 'Participants were recruited from the Nielsen Global Insights Consumer Panel']","['cannabis brownie packaged according to one of three conditions: (a) multiserving edible (""control condition""), (b) single-serving edible, and (c) single-serving edible packaged separately (""unit-dose packaging']",[],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0024808', 'cui_str': 'Marihuana'}, {'cui': 'C0242456', 'cui_str': 'Policy'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0233820', 'cui_str': 'Insight'}, {'cui': 'C0441833', 'cui_str': 'Groups'}]","[{'cui': 'C0024808', 'cui_str': 'Marihuana'}, {'cui': 'C0013194', 'cui_str': 'Packaging, Drug'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}]",[],26894.0,0.0568791,"Compared with the multiserving edible control (50.6%), participants were significantly more likely to correctly identify the serving size in the single-serving edible condition (55.3%; adjusted odds ratio = 1.22, CI [1.15, 1.29], p < .001) and the unit-dose packaging condition (54.3%; adjusted odds ratio = 1.17, CI [1.10, 1.24], p < .001). ","[{'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Goodman', 'Affiliation': 'School of Public Health & Health Systems, University of Waterloo, Waterloo, Ontario, Canada.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Hammond', 'Affiliation': 'School of Public Health & Health Systems, University of Waterloo, Waterloo, Ontario, Canada.'}]",Journal of studies on alcohol and drugs,[] 40,32359042,"Efficacy of the eCHECKUP TO GO for High School Seniors: Sex Differences in Risk Factors, Protective Behavioral Strategies, and Alcohol Use.","OBJECTIVE The purpose of this randomized controlled study was to examine sex as a moderator of the efficacy of a brief, web-based personalized feedback intervention (eCHECKUP TO GO) on decreasing cognitive risk factors for alcohol use, increasing protective behavioral strategies, and reducing alcohol use among high school seniors. METHOD Participants (n = 311) were high school seniors randomized by class period to the eCHECKUP TO GO intervention or assessment-only control group. Participants completed online surveys at baseline and 30-day follow-up (91.0%; n = 283). RESULTS Students in the intervention group reported a significant reduction in normative perceptions of peer drinking, positive alcohol expectancies, and alcohol use relative to those in the control group. Intervention effects for perceptions of frequency of peer drunkenness and frequency of alcohol use were moderated by sex, with results favoring females. In contrast, we did not find evidence for sex as a moderator of intervention effects for normative perceptions of peer drinking frequency, sex-specific perceptions of peer heavy episodic drinking, positive alcohol expectancies, or peak drinking quantity. Further, we did not find significant intervention or moderator effects for protective behavioral strategies. CONCLUSIONS Results of this study extend the literature by demonstrating the efficacy of the eCHECKUP TO GO for both males and females on reducing cognitive risk factors and alcohol use, although results were significant for a broader range of variables for females. Results also indicate that program content regarding normative feedback and protective behavioral strategies may need modification to be more effective for this age group.",2020,"In contrast, we did not find evidence for sex as a moderator of intervention effects for normative perceptions of peer drinking frequency, sex-specific perceptions of peer heavy episodic drinking, positive alcohol expectancies, or peak drinking quantity.","['High School Seniors', 'Participants (n = 311) were high school seniors randomized by class period to the', 'high school seniors']","['eCHECKUP TO GO intervention or assessment-only control group', 'web-based personalized feedback intervention (eCHECKUP TO GO', 'eCHECKUP TO GO']","['normative perceptions of peer drinking, positive alcohol expectancies, and alcohol use relative']","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0456387', 'cui_str': 'Class'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}]","[{'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0679138', 'cui_str': 'Expectations'}, {'cui': 'C0080103', 'cui_str': 'Relative'}]",311.0,0.0172365,"In contrast, we did not find evidence for sex as a moderator of intervention effects for normative perceptions of peer drinking frequency, sex-specific perceptions of peer heavy episodic drinking, positive alcohol expectancies, or peak drinking quantity.","[{'ForeName': 'Diana M', 'Initials': 'DM', 'LastName': 'Doumas', 'Affiliation': 'Institute for the Study of Behavioral Health and Addiction, Boise State University, Boise, Idaho.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Esp', 'Affiliation': 'Institute for the Study of Behavioral Health and Addiction, Boise State University, Boise, Idaho.'}, {'ForeName': 'Rob', 'Initials': 'R', 'LastName': 'Turrisi', 'Affiliation': 'Biobehavioral Health and Prevention Research Center, The Pennsylvania State University, University Park, Pennsylvania.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Bond', 'Affiliation': 'Biomolecular Research Center, Boise State University, Boise, Idaho.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Flay', 'Affiliation': 'Initiative for Healthy Schools, Boise State University, Boise, Idaho.'}]",Journal of studies on alcohol and drugs,[] 41,32361414,Neural correlates of NOS1 ex1f-VNTR allelic variation in panic disorder and agoraphobia during fear conditioning and extinction in fMRI.,"Neuronal nitric oxide synthase (NOS-I) impacts on fear/anxiety-like behavior in animals. In humans, the short (S) allele of a functional promotor polymorphism of NOS1 (NOS1 ex1f-VNTR) has been shown to be associated with higher anxiety and altered fear conditioning in healthy subjects in the amygdala and hippocampus (AMY/HIPP). Here, we explore the role of NOS1 ex1f-VNTR as a pathophysiological correlate of panic disorder and agoraphobia (PD/AG). In a sub-sample of a multicenter cognitive behavioral therapy (CBT) randomized controlled trial in patients with PD/AG (n = 48: S/S-genotype n=15, S/L-genotype n=21, L/L-genotype n=12) and healthy control subjects, HS (n = 34: S/S-genotype n=7, S/L-genotype n=17, L/L-genotype=10), a differential fear conditioning and extinction fMRI-paradigm was used to investigate how NOS1 ex1f-VNTR genotypes are associated with differential neural activation in AMY/HIPP. Prior to CBT, L/L-allele carriers showed higher activation than S/S-allele carriers in AMY/HIPP. A genotype × diagnosis interaction revealed that the S-allele in HS was associated with a pronounced deactivation in AMY/HIPP, while patients showed contrary effects. The interaction of genotype × stimulus type (CS+, conditioned stimulus associated with an aversive stimulus vs. CS-, unassociated) showed effects on differential learning in AMY/HIPP. All effects were predominately found during extinction. Genotype associated effects in patients were not altered after CBT. Low statistical power due to small sample size in each subgroup is a major limitation. However, our findings provide first preliminary evidence for dysfunctional neural fear conditioning/extinction associated with NOS1 ex1f-VNTR genotype in the context of PD/AG, shedding new light on the complex interaction between genetic risk, current psychopathology and treatment-related effects.",2020,Genotype associated effects in patients were not altered after CBT.,"['n\xa0=\xa048', 'healthy subjects', 'animals', 'patients with PD/AG', 'panic disorder and agoraphobia during fear conditioning and extinction in fMRI']",['cognitive behavioral therapy (CBT'],['Neuronal nitric oxide synthase (NOS-I) impacts on fear/anxiety-like behavior'],"[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0003062', 'cui_str': 'Kingdom Animalia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030319', 'cui_str': 'Panic disorder'}, {'cui': 'C0001818', 'cui_str': 'Agoraphobia'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0015347', 'cui_str': 'Psychological Extinction'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C0669368', 'cui_str': 'Nitric Oxide Synthase, Type I'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",,0.0249077,Genotype associated effects in patients were not altered after CBT.,"[{'ForeName': 'Isabelle C', 'Initials': 'IC', 'LastName': 'Ridderbusch', 'Affiliation': 'Department of Psychiatry and Psychotherapy & Center for Mind, Brain and Behavior - CMBB, Philipps-Universität Marburg, Marburg, Germany. Electronic address: isabelle.ridderbusch@med.uni-marburg.de.'}, {'ForeName': 'Yunbo', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Department of Psychiatry and Psychotherapy & Center for Mind, Brain and Behavior - CMBB, Philipps-Universität Marburg, Marburg, Germany.'}, {'ForeName': 'Heike', 'Initials': 'H', 'LastName': 'Weber', 'Affiliation': 'Department of Psychiatry, Psychosomatics, and Psychotherapy, University Hospital of Würzburg, Würzburg, Germany; Department of Psychiatry, Psychosomatic Medicine and Psychotherapy, University Hospital Frankfurt, Frankfurt am Main, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Reif', 'Affiliation': 'Department of Psychiatry, Psychosomatic Medicine and Psychotherapy, University Hospital Frankfurt, Frankfurt am Main, Germany.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Herterich', 'Affiliation': 'Clinical Chemistry and Laboratory Medicine, University Hospital Würzburg, Würzburg, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Ströhle', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Campus Charité Mitte, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany.'}, {'ForeName': 'Bettina', 'Initials': 'B', 'LastName': 'Pfleiderer', 'Affiliation': 'Medical Faculty, University of Münster and Department Clinical Radiology, University Hospital Münster, Münster, Germany.'}, {'ForeName': 'Volker', 'Initials': 'V', 'LastName': 'Arolt', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Hospital Münster, Münster, Germany.'}, {'ForeName': 'Hans-Ulrich', 'Initials': 'HU', 'LastName': 'Wittchen', 'Affiliation': 'Institute of Clinical Psychology and Psychotherapy, Technische Universität Dresden, Dresden, Germany; Department of Psychiatry and Psychotherapy, Ludwig-Maximilians-Universität (LMU), München, Germany.'}, {'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'Lueken', 'Affiliation': 'Department of Psychology, Humboldt-Universität zu Berlin, Berlin, Germany.'}, {'ForeName': 'Tilo', 'Initials': 'T', 'LastName': 'Kircher', 'Affiliation': 'Department of Psychiatry and Psychotherapy & Center for Mind, Brain and Behavior - CMBB, Philipps-Universität Marburg, Marburg, Germany.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Straube', 'Affiliation': 'Department of Psychiatry and Psychotherapy & Center for Mind, Brain and Behavior - CMBB, Philipps-Universität Marburg, Marburg, Germany.'}]",NeuroImage. Clinical,['10.1016/j.nicl.2020.102268'] 42,32301900,Enthusiastic claims for open-label placebo pills ignore the evidence.,,2020,,[],[],[],[],[],[],,0.0910769,,"[{'ForeName': 'Anita B', 'Initials': 'AB', 'LastName': 'Amorim', 'Affiliation': 'The University of Sydney, Sydney School of Public Health, Faculty of Medicine and Health, Sydney, New South Wales, Australia.'}, {'ForeName': 'Gustavo C', 'Initials': 'GC', 'LastName': 'Machado', 'Affiliation': 'The University of Sydney, Sydney School of Public Health, Faculty of Medicine and Health, Sydney, New South Wales, Australia.'}, {'ForeName': 'Chris G', 'Initials': 'CG', 'LastName': 'Maher', 'Affiliation': 'The University of Sydney, Sydney School of Public Health, Faculty of Medicine and Health, Sydney, New South Wales, Australia.'}]",Pain,['10.1097/j.pain.0000000000001803'] 43,32368032,Erratum: Inhaled Corticosteroid Treatment Regimens and Health Outcomes in a UK COPD Population Study [Corrigendum].,[This corrects the article DOI: 10.2147/COPD.S241568.].,2020,[This corrects the article DOI: 10.2147/COPD.S241568.].,[],['Corticosteroid'],[],[],"[{'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}]",[],,0.0212237,[This corrects the article DOI: 10.2147/COPD.S241568.].,[],International journal of chronic obstructive pulmonary disease,['10.2147/COPD.S257551'] 44,32367446,Educational value of telementoring for a simulation-based fundamental use of surgical energy™ (FUSE) curriculum: a randomized controlled trial in surgical trainees.,"INTRODUCTION The SAGES Fundamental Use of Surgical Energy (FUSE) program accompanied by a bench-top simulation has shown to improve knowledge of the safe use of energy devices. However, there are significant barriers and costs associated with delivering an effective structured simulation curriculum to a widespread international audience. The purpose of this study was to evaluate if bench-top simulation FUSE curriculum through telementoring is as effective as a live-in house proctor for electrosurgical training. METHODS A two-armed multi-institutional randomized controlled trial was designed, including a 1-h didactic electrosurgery course (FUSE curriculum), followed by a structured 1-h bench-top simulation training session. For the simulation, participants were randomized to either a live proctor who delivered the course on-site (LIVE group), or a proctor from a remote location using videoconferencing platform (TELEM group). Pre- and post-curriculum (immediate and 6 months) knowledge and self-perceived comfort and competence were assessed. Data are expressed as median [interquartile range], *p < 0.05. RESULTS Sixty-five (35 LIVE; 30 TELEM) surgical trainees from three institutions participated. Baseline characteristics were similar. Total score on the exam improved from 47% [40-54] to 78% [71-84]* amongst all participants, with similar immediate post-curriculum scores in the LIVE group compared to the TELEM group (77% [69-83] vs 80% [75-85]). At 6 months, performance on the exam declined significantly for both groups, but remained similar between the two (LIVE: 59% [51-71] vs TELEM: 71% [57-77]). Participants in both groups reported feeling greater comfort and competence post-curriculum (immediate and at 6 months) compared to baseline, with no difference between the two groups. CONCLUSION A bench-top simulation FUSE course delivered via a telementoring platform seems to improve surgical trainees' knowledge and comfort in the safe use of electrosurgical devices as effectively as when it is delivered by a live proctor, despite long-term decay for both methods.",2020,"Participants in both groups reported feeling greater comfort and competence post-curriculum (immediate and at 6 months) compared to baseline, with no difference between the two groups. ","['surgical trainees from three institutions participated', 'Sixty-five']","['live proctor who delivered the course on-site (LIVE group), or a proctor from a remote location using videoconferencing platform (TELEM group', 'Pre- and post-curriculum ', 'didactic electrosurgery course (FUSE curriculum', 'surgical energy™ (FUSE) curriculum', 'TELEM']","['feeling greater comfort and competence post-curriculum', 'immediate and 6\xa0months) knowledge and self-perceived comfort and competence', 'Total score']","[{'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0450385', 'cui_str': '65'}]","[{'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0450429', 'cui_str': 'Location'}, {'cui': 'C1450048', 'cui_str': 'Videoconferencing'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0010478', 'cui_str': 'Curricula'}, {'cui': 'C0012002', 'cui_str': 'Diathermy'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}]","[{'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0010478', 'cui_str': 'Curricula'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.188381,"Participants in both groups reported feeling greater comfort and competence post-curriculum (immediate and at 6 months) compared to baseline, with no difference between the two groups. ","[{'ForeName': 'Maria S', 'Initials': 'MS', 'LastName': 'Altieri', 'Affiliation': 'Division of General and Bariatric Surgery, Department of Surgery, East Carolina University Brody School of Medicine, 600 Moye Boulevard, Greenville, NC, 27834, USA. altierim19@ecu.edu.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Carmichael', 'Affiliation': 'Department of Surgery, University of Colorado School of Medicine, Aurora, CO, USA.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Jones', 'Affiliation': 'Department of Surgery, University of Colorado School of Medicine, Aurora, CO, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Robinson', 'Affiliation': 'Department of Surgery, University of Colorado School of Medicine, Aurora, CO, USA.'}, {'ForeName': 'Aurora', 'Initials': 'A', 'LastName': 'Pryor', 'Affiliation': 'Department of Surgery, Stony Brook University Medical Center, Stony Brook, NY, USA.'}, {'ForeName': 'Amin', 'Initials': 'A', 'LastName': 'Madani', 'Affiliation': 'Department of Surgery, University Health Network, Toronto, ON, Canada.'}]",Surgical endoscopy,['10.1007/s00464-020-07609-1'] 45,32359153,Substituting Lean Beef for Carbohydrate in a Healthy Dietary Pattern Does Not Adversely Affect the Cardiometabolic Risk Factor Profile in Men and Women at Risk for Type 2 Diabetes.,"BACKGROUND Observational evidence suggests that red meat intake is associated with type 2 diabetes (T2D) and cardiovascular disease incidence, but few randomized controlled trials have assessed effects of lean, unprocessed red meat intake on insulin sensitivity and other cardiometabolic risk factors. OBJECTIVE This study compared the USDA Healthy US-Style Eating Pattern, low in saturated fat and red meat (<40 g/d red meat; USDA-CON), with a modified version with an additional 150 g/d lean beef as an isocaloric replacement for carbohydrate (USDA-LB) on insulin sensitivity and cardiometabolic risk markers. METHODS Participants (7 men, 26 women; 44.4 y old) with overweight/obesity [BMI (kg/m2) = 31.3] and prediabetes and/or metabolic syndrome completed this randomized, crossover, controlled-feeding trial consisting of two 28-d treatments (USDA-CON and USDA-LB) separated by a ≥14-day washout. Insulin sensitivity (primary outcome variable), lipoprotein lipids, apolipoproteins (apoA-I and apoB), and high-sensitivity C-reactive protein (hs-CRP) (secondary outcome variables), in plasma or serum, and blood pressures were assessed at baseline and the end of each diet period. RESULTS USDA-LB and USDA-CON did not differ significantly in effects on whole-body insulin sensitivity and other indicators of carbohydrate metabolism, lipoprotein lipids, apoA-I and apoB, hs-CRP, and blood pressures. USDA-LB produced a shift toward less cholesterol carried by smaller LDL subfractions compared with USDA-CON [least-squares geometric mean ratios for LDL1+2 cholesterol of 1.20 (P = 0.016) and LDL3+4 cholesterol of 0.89 (P = 0.044)] and increased peak LDL time versus USDA-CON (1.01; P = 0.008). CONCLUSIONS Substituting lean, unprocessed beef for carbohydrate in a Healthy US-Style Eating Pattern resulted in a shift toward larger, more buoyant LDL subfractions, but otherwise had no significant effects on the cardiometabolic risk factor profile in men and women with prediabetes and/or metabolic syndrome.This trial was registered at clinicaltrials.gov as NCT03202680.",2020,"RESULTS USDA-LB and USDA-CON did not differ significantly in effects on whole-body insulin sensitivity and other indicators of carbohydrate metabolism, lipoprotein lipids, apoA-I and apoB, hs-CRP, and blood pressures.","['men and women with prediabetes and/or metabolic syndrome', 'Men and Women at Risk for Type 2 Diabetes', 'Substituting Lean Beef for Carbohydrate in a Healthy Dietary Pattern', 'Participants (7 men, 26 women; 44.4 y old) with overweight/obesity [BMI (kg/m2)\xa0=\xa031.3] and prediabetes']",[],"['whole-body insulin sensitivity and other indicators of carbohydrate metabolism, lipoprotein lipids, apoA-I and apoB, hs-CRP, and blood pressures', 'peak LDL time', 'cardiometabolic risk factor profile', 'Insulin sensitivity (primary outcome variable), lipoprotein lipids, apolipoproteins (apoA-I and apoB), and high-sensitivity C-reactive protein (hs-CRP) (secondary outcome variables), in plasma or serum, and blood pressures', 'Cardiometabolic Risk Factor Profile']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0271650', 'cui_str': 'Impaired glucose tolerance'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0452849', 'cui_str': 'Beef'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}]",[],"[{'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0302820', 'cui_str': 'Metabolism, Carbohydrate'}, {'cui': 'C0023820', 'cui_str': 'Lipoprotein'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0085201', 'cui_str': 'Apolipoprotein A-I'}, {'cui': 'C0003593', 'cui_str': 'Apolipoprotein B'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0003591', 'cui_str': 'Apolipoprotein'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0229671', 'cui_str': 'Serum'}]",,0.238139,"RESULTS USDA-LB and USDA-CON did not differ significantly in effects on whole-body insulin sensitivity and other indicators of carbohydrate metabolism, lipoprotein lipids, apoA-I and apoB, hs-CRP, and blood pressures.","[{'ForeName': 'Kevin C', 'Initials': 'KC', 'LastName': 'Maki', 'Affiliation': 'Midwest Biomedical Research Center for Metabolic and Cardiovascular Health, Addison, IL, USA.'}, {'ForeName': 'Meredith L', 'Initials': 'ML', 'LastName': 'Wilcox', 'Affiliation': 'Midwest Biomedical Research Center for Metabolic and Cardiovascular Health, Addison, IL, USA.'}, {'ForeName': 'Mary R', 'Initials': 'MR', 'LastName': 'Dicklin', 'Affiliation': 'Midwest Biomedical Research Center for Metabolic and Cardiovascular Health, Addison, IL, USA.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Buggia', 'Affiliation': 'Midwest Biomedical Research Center for Metabolic and Cardiovascular Health, Addison, IL, USA.'}, {'ForeName': 'Orsolya M', 'Initials': 'OM', 'LastName': 'Palacios', 'Affiliation': 'Midwest Biomedical Research Center for Metabolic and Cardiovascular Health, Addison, IL, USA.'}, {'ForeName': 'Cathleen E', 'Initials': 'CE', 'LastName': 'Maki', 'Affiliation': 'Midwest Biomedical Research Center for Metabolic and Cardiovascular Health, Addison, IL, USA.'}, {'ForeName': 'Melvyn', 'Initials': 'M', 'LastName': 'Kramer', 'Affiliation': 'Midwest Biomedical Research Center for Metabolic and Cardiovascular Health, Addison, IL, USA.'}]",The Journal of nutrition,['10.1093/jn/nxaa116'] 46,32368027,"Efficacy and Safety of Once-Daily Inhaled Umeclidinium in Asian Patients with COPD: Results from a Randomized, Placebo-Controlled Study.","Purpose Previous studies demonstrating efficacy and safety of once-daily umeclidinium (UMEC) in patients with chronic obstructive pulmonary disease (COPD) have included few Asian patients. This study evaluated efficacy and safety of UMEC 62.5 mcg versus placebo in Asian patients with COPD. Patients and Methods A Phase III, randomized, double-blind, parallel-group study. Patients (aged ≥40 years with COPD, pre-, and post-albuterol forced expiratory volume in 1 s [FEV 1 ]/forced vital capacity ratio <0.70 and low risk of exacerbations) were randomized 2:1 to once-daily UMEC 62.5 mcg or placebo via the ELLIPTA inhaler for 24 weeks. Primary endpoint was change from baseline (CFB) in trough FEV 1 on Day 169. Secondary endpoints were weighted mean FEV 1 over 0-6 hrs post-dose on Day 1 and CFB in Transition Dyspnea Index (TDI) focal score on Day 168. Results A total of 306 patients were included in the modified intent-to-treat population (UMEC: 205; placebo: 101). UMEC versus placebo provided a statistically significant improvement in least squares (LS) mean trough FEV 1 between baseline and Day 169 (154 mL [95% confidence interval (CI): 113, 194]; p<0.001). A clinically meaningful difference of 125 mL in favor of UMEC (95% CI: 103, 147; p<0.001) was also seen in LS weighted mean FEV 1 0-6 hrs post-dose on Day 1. A LS mean treatment difference in TDI focal score of 0.9 units in favor of UMEC was seen on Day 168 (95% CI: 0.3, 1.5; p=0.004). Incidence of on-treatment adverse events (AEs) was lower in the placebo (55%) versus UMEC arm (60%); non-fatal serious AEs, drug-related AEs, and AEs leading to withdrawal were similar with UMEC and placebo. Conclusion Once-daily UMEC 62.5 mcg resulted in statistically significant and clinically meaningful improvements in lung function and dyspnea, compared with placebo, in Asian patients with COPD, with no new safety concerns observed.",2020,"Incidence of on-treatment adverse events (AEs) was lower in the placebo (55%) versus UMEC arm (60%); non-fatal serious AEs, drug-related AEs, and AEs leading to withdrawal were similar with UMEC and placebo. ","['Asian patients with COPD', 'patients with chronic obstructive pulmonary disease (COPD) have included few Asian patients', 'Patients (aged ≥40 years with COPD, pre-, and post-albuterol forced expiratory volume in 1 s [FEV 1 ', '306 patients were included in the modified intent-to-treat population (UMEC: 205', 'Asian Patients with COPD']","['Placebo', 'UMEC versus placebo', 'UMEC', 'once-daily umeclidinium (UMEC', 'Once-Daily Inhaled Umeclidinium', 'UMEC 62.5 mcg or placebo', 'placebo']","['Efficacy and Safety', 'Incidence of on-treatment adverse events (AEs', 'lung function and dyspnea', 'weighted mean FEV 1 over 0-6 hrs post-dose on Day 1 and CFB in Transition Dyspnea Index (TDI) focal score', 'change from baseline (CFB', 'TDI focal score', 'least squares (LS) mean trough FEV']","[{'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0001927', 'cui_str': 'Albuterol'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C3661274', 'cui_str': 'umeclidinium'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3661274', 'cui_str': 'umeclidinium'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C4517836', 'cui_str': '62.5'}, {'cui': 'C0439211', 'cui_str': 'mcg'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0439568', 'cui_str': 'Post-dose'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205234', 'cui_str': 'Focal'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205976', 'cui_str': 'Toluene di-isocyanate-containing product'}, {'cui': 'C0023189', 'cui_str': 'Analysis, Least-Squares'}, {'cui': 'C0444506', 'cui_str': 'Trough'}, {'cui': 'C1306036', 'cui_str': 'Forced expiratory volume'}]",306.0,0.732537,"Incidence of on-treatment adverse events (AEs) was lower in the placebo (55%) versus UMEC arm (60%); non-fatal serious AEs, drug-related AEs, and AEs leading to withdrawal were similar with UMEC and placebo. ","[{'ForeName': 'Nanshan', 'Initials': 'N', 'LastName': 'Zhong', 'Affiliation': ""State Key Laboratory of Respiratory Disease, National Clinical Research Centre of Respiratory Disease, Guangzhou Institute of Respiratory Health, First Affiliated Hospital of Guangzhou Medical University, Guangzhou, People's Republic of China.""}, {'ForeName': 'Jinping', 'Initials': 'J', 'LastName': 'Zheng', 'Affiliation': ""State Key Laboratory of Respiratory Disease, National Clinical Research Centre of Respiratory Disease, Guangzhou Institute of Respiratory Health, First Affiliated Hospital of Guangzhou Medical University, Guangzhou, People's Republic of China.""}, {'ForeName': 'Sang Haak', 'Initials': 'SH', 'LastName': 'Lee', 'Affiliation': ""Department of Internal Medicine, Eunpyeong St. Mary's Hospital, College of Medicine, the Catholic University of Korea, Seoul, South Korea.""}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Lipson', 'Affiliation': 'GSK, Collegeville, and Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Du', 'Affiliation': ""GSK, Shanghai, People's Republic of China.""}, {'ForeName': 'Shunquan', 'Initials': 'S', 'LastName': 'Wu', 'Affiliation': ""GSK, Shanghai, People's Republic of China.""}]",International journal of chronic obstructive pulmonary disease,['10.2147/COPD.S215011'] 47,32361220,Clinical impact of lung ultrasound monitoring for diagnosis of ventilator associated pneumonia: A diagnostic randomized controlled trial.,"PURPOSE Studies have shown that lung-ultrasound may be superior to chest x-ray (CXR) in diagnosing ventilator-associated pneumonia (VAP). This study investigated whether the use of lung-ultrasound monitoring could detect VAP earlier and improve patient outcome. METHODS This was a single-center diagnostic randomized controlled trial. In the control group, VAP was diagnosed using a combination of CXR and clinical findings. In the intervention group, VAP was diagnosed using a combination of lung-ultrasound and clinical findings. The primary outcome measured was ventilator free days (VFD). Secondary outcomes were ICU mortality, length of stay in ICU, change in Sequential Organ Failure Score at day 4 compared to day 0 (delta SOFA), antibiotic duration and ventilator days. RESULTS We randomized intubated patients until 44 VAP diagnosis was made in each group. VFD was higher in the intervention group than in the control group (7.80+/- 9.7 days versus 3.7+/- 6.4 days, p = .044). There were no differences between the groups in terms of ICU mortality (p=.104), ICU length of stay, (p = .058), ventilator days, (p = .081), delta SOFA (p = .10) and antibiotic duration (p = .70). CONCLUSION The use of lung-ultrasound monitoring for diagnosis of VAP improves patient outcome when compared to the standard diagnostic strategy that relies on CXR.",2020,"There were no differences between the groups in terms of ICU mortality (p=.104), ICU length of stay, (p = .058), ventilator days, (p = .081), delta SOFA (p = .10) and antibiotic duration (p = .70). ",['diagnosis of ventilator associated pneumonia'],"['VAP', 'lung ultrasound monitoring', 'lung-ultrasound monitoring']","['ICU length of stay', 'delta SOFA', 'ICU mortality, length of stay in ICU, change in Sequential Organ Failure Score at day 4 compared to day 0 (delta SOFA), antibiotic duration and ventilator days', 'ICU mortality', 'antibiotic duration', 'ventilator free days (VFD', 'VFD']","[{'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0087153', 'cui_str': 'Ventilator'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}]","[{'cui': 'C0087153', 'cui_str': 'Ventilator'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C4286019', 'cui_str': 'Lung ultrasound'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}]","[{'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0439097', 'cui_str': 'Delta'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C3494460', 'cui_str': 'Organ Failure Scores'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0087153', 'cui_str': 'Ventilator'}, {'cui': 'C0332296', 'cui_str': 'Free of'}]",,0.170703,"There were no differences between the groups in terms of ICU mortality (p=.104), ICU length of stay, (p = .058), ventilator days, (p = .081), delta SOFA (p = .10) and antibiotic duration (p = .70). ","[{'ForeName': 'Saurabh', 'Initials': 'S', 'LastName': 'Pradhan', 'Affiliation': 'Department of Anaesthesiology, Tribhuvan University Teaching Hospital, Maharajgunj, Kathmandu, Nepal. Electronic address: saurabh_44@hotmail.com.'}, {'ForeName': 'Pramesh Sunder', 'Initials': 'PS', 'LastName': 'Shrestha', 'Affiliation': 'Department of Anaesthesiology, Tribhuvan University Teaching Hospital, Maharajgunj, Kathmandu, Nepal.'}, {'ForeName': 'Gentle Sunder', 'Initials': 'GS', 'LastName': 'Shrestha', 'Affiliation': 'Department of Anaesthesiology, Tribhuvan University Teaching Hospital, Maharajgunj, Kathmandu, Nepal.'}, {'ForeName': 'Moda Nath', 'Initials': 'MN', 'LastName': 'Marhatta', 'Affiliation': 'Department of Anaesthesiology, Tribhuvan University Teaching Hospital, Maharajgunj, Kathmandu, Nepal.'}]",Journal of critical care,['10.1016/j.jcrc.2020.03.012'] 48,32301241,Health professionals' perspectives on delivering home and hospital management at diagnosis for children with type 1 diabetes: A qualitative study from the Delivering Early Care in Diabetes Evaluation trial.,"OBJECTIVE To explore the delivery of home and hospital management at diagnosis of type 1 diabetes in childhood and any impact this had on health professionals delivering care. METHODS This qualitative study was undertaken as part of the Delivering Early Care in Diabetes Evaluation randomized controlled trial where participants were individually randomized to receive initiation of management at diagnosis, to home or hospital. Semi-structured telephone interviews were planned with a purposive sample of health professionals involved with the delivery of home and hospital management, to include consultants, diabetes and research nurses, and dieticians from the eight UK centres taking part. The interview schedule focused on their experiences of delivering the two models of care; preferences, impact, and future plans. Data were subject to thematic analysis. RESULTS Twenty-two health professionals participated, represented by consultants, diabetes and research nurses, and dieticians. Overall, nurses preferred home management and perceived it to be beneficial in terms of facilitating a unique opportunity to understand family life and provide education to extended family members. Nurses described a special bond and lasting relationship that they developed with the home managed children and families. Consultants expressed concern that it jeopardized their relationship with families. Dieticians reported being unable to deliver short bursts of education to families in the home managed arm. All health professionals were equally divided over which was logistically easier to deliver. CONCLUSIONS A hybrid approach, of a brief stay in hospital and early home management, offers a pragmatic solution to the advantages and challenges presented by both systems.",2020,"Overall, nurses preferred home management and perceived it to be beneficial in terms of facilitating a unique opportunity to understand family life and provide education to extended family members.","['children with type 1 diabetes', 'Twenty two health professionals participated, represented by consultants, diabetes and research nurses, and dietitians']",[],[],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C4284772', 'cui_str': '22'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0009817', 'cui_str': 'Consultant'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0687693', 'cui_str': 'Research nurse'}, {'cui': 'C0334932', 'cui_str': 'Dietitian (general)'}]",[],[],,0.0531353,"Overall, nurses preferred home management and perceived it to be beneficial in terms of facilitating a unique opportunity to understand family life and provide education to extended family members.","[{'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Townson', 'Affiliation': 'Centre for Trials Research (CTR), College of Biomedical and Life Sciences, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Lesley', 'Initials': 'L', 'LastName': 'Lowes', 'Affiliation': 'School of Healthcare Sciences, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Robling', 'Affiliation': 'Centre for Trials Research (CTR), College of Biomedical and Life Sciences, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Kerry', 'Initials': 'K', 'LastName': 'Hood', 'Affiliation': 'Centre for Trials Research (CTR), College of Biomedical and Life Sciences, Cardiff University, Cardiff, UK.'}, {'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'Gregory', 'Affiliation': 'Division of Population Medicine, School of Medicine, Cardiff University, Cardiff, UK.'}]",Pediatric diabetes,['10.1111/pedi.13023'] 49,32363775,Patient and clinician experience of a serious illness conversation guide in oncology: A descriptive analysis.,"BACKGROUND/OBJECTIVE Oncology guidelines recommend earlier communication with patients about prognosis and goals-of-care in serious illness. However, current evidence leaves gaps in our understanding of the experience of these conversations. This analysis evaluates the patient and clinician experience of a conversation using a Serious Illness Conversation Guide (SICG). DESIGN/SETTING Secondary analysis from a cluster-randomized clinical trial in a northeastern cancer center. PARTICIPANTS Physicians, advanced practice clinicians, and patients with advanced cancer who received the intervention. INTERVENTION SICG, clinician training, systems-changes. MAIN OUTCOMES AND MEASURES The patient questionnaire assessed perceptions of the conversation and impact on anxiety, hopefulness, peacefulness, sense of control over medical decisions, closeness with their clinician, and behaviors. The clinician questionnaire assessed feasibility, acceptability, and impact on satisfaction in their role. RESULTS We enrolled 54 clinicians and 163 patients; 41 clinicians and 118 patients had a SICG discussion. Most patients described the conversation as worthwhile (79%) and reported no change or improvement in their sense of peacefulness, hopefulness, and anxiety (on average 79%); 56% reported feeling closer with their clinician. Qualitative patient data described positive behavior changes, including enhanced planning for future care and increased focus on personal priorities. Nearly 90% of clinicians agreed that the SICG facilitated timely, effective conversations, and 70% reported increased satisfaction in their role. CONCLUSION Conversations using a SICG were feasible, acceptable, and were associated with positive experiences for both patients and clinicians in oncology in ways that align with national recommendations for serious illness communication. This trial is registered at ClinicalTrials.gov: NCT01786811 https://clinicaltrials.gov/ct2/show/NCT01786811.",2020,"Most patients described the conversation as worthwhile (79%) and reported no change or improvement in their sense of peacefulness, hopefulness, and anxiety (on average 79%); 56% reported feeling closer with their clinician.","['Patient and clinician experience of a serious illness conversation guide in oncology', 'Secondary analysis from a cluster-randomized clinical trial in a northeastern cancer center', 'We enrolled 54 clinicians and 163 patients; 41 clinicians and 118 patients had a SICG discussion', 'Physicians, advanced practice clinicians, and patients with advanced cancer who received the intervention']",[],"['satisfaction', 'clinician questionnaire assessed feasibility, acceptability, and impact on satisfaction', 'sense of peacefulness, hopefulness, and anxiety', 'anxiety, hopefulness, peacefulness, sense of control over medical decisions, closeness with their clinician, and behaviors']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0557061', 'cui_str': 'Discussion'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],"[{'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0392347', 'cui_str': 'Hope'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0021783', 'cui_str': 'External-Internal Control'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",54.0,0.0775545,"Most patients described the conversation as worthwhile (79%) and reported no change or improvement in their sense of peacefulness, hopefulness, and anxiety (on average 79%); 56% reported feeling closer with their clinician.","[{'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Paladino', 'Affiliation': ""Ariadne Labs, Brigham and Women's Hospital, Harvard T.H. Chan School of Public Health, Boston, MA, USA.""}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Koritsanszky', 'Affiliation': ""Ariadne Labs, Brigham and Women's Hospital, Harvard T.H. Chan School of Public Health, Boston, MA, USA.""}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Nisotel', 'Affiliation': ""Ariadne Labs, Brigham and Women's Hospital, Harvard T.H. Chan School of Public Health, Boston, MA, USA.""}, {'ForeName': 'Bridget A', 'Initials': 'BA', 'LastName': 'Neville', 'Affiliation': ""Ariadne Labs, Brigham and Women's Hospital, Harvard T.H. Chan School of Public Health, Boston, MA, USA.""}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Miller', 'Affiliation': ""Ariadne Labs, Brigham and Women's Hospital, Harvard T.H. Chan School of Public Health, Boston, MA, USA.""}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Sanders', 'Affiliation': ""Ariadne Labs, Brigham and Women's Hospital, Harvard T.H. Chan School of Public Health, Boston, MA, USA.""}, {'ForeName': 'Evan', 'Initials': 'E', 'LastName': 'Benjamin', 'Affiliation': ""Ariadne Labs, Brigham and Women's Hospital, Harvard T.H. Chan School of Public Health, Boston, MA, USA.""}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Fromme', 'Affiliation': ""Ariadne Labs, Brigham and Women's Hospital, Harvard T.H. Chan School of Public Health, Boston, MA, USA.""}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Block', 'Affiliation': 'Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Rachelle', 'Initials': 'R', 'LastName': 'Bernacki', 'Affiliation': 'Harvard Medical School, Boston, MA, USA.'}]",Cancer medicine,['10.1002/cam4.3102'] 50,32363614,Statistical properties of minimal sufficient balance and minimization as methods for controlling baseline covariate imbalance at the design stage of sequential clinical trials.,"When the number of baseline covariates whose imbalance needs to be controlled in a sequential randomized controlled trial is large, minimization is the most commonly used method for randomizing treatment assignments. The lack of allocation randomness associated with the minimization method has been the source of controversy, and the need to reduce even minor imbalances inherent in the minimization method has been challenged. The minimal sufficient balance (MSB) method is an alternative to the minimization method. It prevents serious imbalance from a large number of covariates while maintaining a high level of allocation randomness. In this study, the two treatment allocation methods are compared with regards to the effectiveness of balancing covariates across treatment arms and allocation randomness in equal allocation clinical trials. The MSB method proves to be equal or superior in both respects. In addition, type I error rate is preserved in analyses for both balancing methods, when using a binary endpoint.",2020,The MSB method proves to be equal or superior in both respects.,[],[],[],[],[],[],,0.0750872,The MSB method proves to be equal or superior in both respects.,"[{'ForeName': 'Steven D', 'Initials': 'SD', 'LastName': 'Lauzon', 'Affiliation': 'Department of Public Health Sciences, Medical University of South Carolina, Charleston, South Carolina, USA.'}, {'ForeName': 'Viswanathan', 'Initials': 'V', 'LastName': 'Ramakrishnan', 'Affiliation': 'Department of Public Health Sciences, Medical University of South Carolina, Charleston, South Carolina, USA.'}, {'ForeName': 'Paul J', 'Initials': 'PJ', 'LastName': 'Nietert', 'Affiliation': 'Department of Public Health Sciences, Medical University of South Carolina, Charleston, South Carolina, USA.'}, {'ForeName': 'Jody D', 'Initials': 'JD', 'LastName': 'Ciolino', 'Affiliation': 'Department of Preventive Medicine, Northwestern University, Chicago, Illinois, USA.'}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Hill', 'Affiliation': 'Department of Clinical Neuroscience, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Wenle', 'Initials': 'W', 'LastName': 'Zhao', 'Affiliation': 'Department of Public Health Sciences, Medical University of South Carolina, Charleston, South Carolina, USA.'}]",Statistics in medicine,['10.1002/sim.8552'] 51,32366615,Oral nitroglycerin solution for oesophageal food impaction: a prospective single-arm pilot study.,"BACKGROUND Thirteen episodes of oesophageal food impaction (EFI) per 100 000 people present to a medical setting each year. Several pharmacological interventions meant to relieve such impactions have been explored; none have proven superior. OBJECTIVES Perform a single-arm feasibility study of oral nitroglycerin solution for EFI. METHODS Twenty adult patients presenting to a single urban tertiary medical centre thought to have EFI were given up to three doses of 0.4 mg nitroglycerin solution orally and evaluated for resolution of symptoms, new symptoms and vital signs. Patients with intractable vomiting, haemodynamic instability, airway compromise, oesophageal perforation, coronary ischaemia or presentation delayed greater than 12 hours were excluded. RESULTS 17 of 20 enrolled subjects received the intervention. The average duration of symptoms prior to intervention was 285 min (SD=187). Four subjects did not tolerate the intervention (inability to swallow or headache). Two of 17 (11.8%) subjects obtained temporally proximal symptom resolution: 11 min after the second dose, and 7 min after the third dose. Seven also received glucagon during their visit, with 0% temporally proximal symptom resolution. Fifteen underwent endoscopy, with food bolus identified in 12. One subject had brief and mild hypotension with spontaneous resolution. Two subjects developed a headache after nitroglycerin administration. The median length of stay for those who found relief without endoscopy was 195 min (range 129-261) vs 374 min (range 122-525) among those with endoscopy. CONCLUSION The observed rate of relief after oral nitroglycerin solution for EFI is disappointing but comparable to previous glucagon, benzodiazepines and effervescent beverage studies, and that of placebo. Oral nitroglycerin solution appears to be well tolerated among those able to swallow, although in our sample several subjects were unable to tolerate swallowing entirely.",2020,The median length of stay for those who found relief without endoscopy was 195 min (range 129-261),"['Patients with intractable vomiting, haemodynamic instability, airway compromise, oesophageal perforation, coronary ischaemia or presentation delayed greater than 12\u2009hours were excluded', '17 of 20 enrolled subjects', 'oesophageal food impaction', 'range 122-525) among those with endoscopy', 'Twenty adult patients presenting to a single urban tertiary medical centre thought to have EFI were given up to three doses of 0.4', 'Thirteen episodes of oesophageal food impaction (EFI) per 100\u2009000 people present to a medical setting each year']","['Oral nitroglycerin solution', 'oral nitroglycerin solution', 'nitroglycerin', 'glucagon', 'placebo']","['headache', 'average duration of symptoms', 'resolution of symptoms, new symptoms and vital signs', 'median length of stay']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0948268', 'cui_str': 'Hemodynamic instability'}, {'cui': 'C4055482', 'cui_str': 'Airway compromise'}, {'cui': 'C0014860', 'cui_str': 'Perforation of esophagus'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C0449450', 'cui_str': 'Presentation'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C1292430', 'cui_str': '12 hours'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C1695984', 'cui_str': 'Oesophageal food impaction'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0039869', 'cui_str': 'Thinking'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C4517457', 'cui_str': '0.4'}, {'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0017887', 'cui_str': 'Nitroglycerin'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0017687', 'cui_str': 'Glucagon'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0436359', 'cui_str': 'Time symptom lasts'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}]",20.0,0.0584806,The median length of stay for those who found relief without endoscopy was 195 min (range 129-261),"[{'ForeName': 'Benjamin Aaron', 'Initials': 'BA', 'LastName': 'Willenbring', 'Affiliation': 'Department of Emergency Medicine, Regions Hospital, Saint Paul, Minnesota, USA ben.willenbring@gmail.com.'}, {'ForeName': 'Callie Korliss', 'Initials': 'CK', 'LastName': 'Schnitker', 'Affiliation': 'Department of Emergency Medicine, Regions Hospital, Saint Paul, Minnesota, USA.'}, {'ForeName': 'Samuel J', 'Initials': 'SJ', 'LastName': 'Stellpflug', 'Affiliation': 'Department of Emergency Medicine, Regions Hospital, Saint Paul, Minnesota, USA.'}]",Emergency medicine journal : EMJ,['10.1136/emermed-2019-209320'] 52,32363636,Task-specific strength increases after lower-limb compound resistance training occurred in the absence of corticospinal changes in vastus lateralis.,"NEW FINDINGS What is the central question of the study? Are corticospinal responses to acute and short-term squat resistance training task-specific? What is the main finding and its importance? A single bout of resistance training increased spinal excitability, but no changes in corticospinal responses were noted following 4 weeks of squat training despite task-specific increases in strength. The present data suggest that processes along the corticospinal pathway of the knee extensors play a limited role in the task-specific increase in strength following resistance training. ABSTRACT Neural adaptations subserving strength increases have been shown to be task-specific, but responses and adaptation to lower-limb compound exercises such as the squat are commonly assessed in a single-limb isometric task. This two-part study assessed neuromuscular responses to an acute bout (Study A) and 4 weeks (Study B) of squat resistance training at 80% of one-repetition-maximum, with measures taken during a task-specific isometric squat (IS) and non-specific isometric knee extension (KE). Eighteen healthy volunteers (25 ± 5 years) were randomised into either a training (n = 10) or a control (n = 8) group. Neural responses were evoked at the intracortical, corticospinal and spinal levels, and muscle thickness was assessed using ultrasound. The results of Study A showed that the acute bout of squat resistance training decreased maximum voluntary contraction (MVC) for up to 45 min post-exercise (-23%, P < 0.001). From 15-45 min post-exercise, spinally evoked responses were increased in both tasks (P = 0.008); however, no other evoked responses were affected (P ≥ 0.240). Study B demonstrated that following short-term resistance training, participants improved their one repetition maximum squat (+35%, P < 0.001), which was reflected by a task-specific increase in IS MVC (+49%, P = 0.001), but not KE (+1%, P = 0.882). However, no training-induced changes were observed in muscle thickness (P = 0.468) or any evoked responses (P = 0.141). Adjustments in spinal motoneuronal excitability are evident after acute resistance training. After a period of short-term training, there were no changes in the responses to central nervous system stimulation, which suggests that alterations in corticospinal properties of the vastus lateralis might not contribute to increases in strength.",2020,"A single bout of resistance training increased spinal excitability, however no changes in corticospinal responses were noted following 4 weeks of squat training despite task-specific increases in strength.",['Eighteen healthy volunteers (25\xa0±\xa05 years'],"['squat resistance training at 80% of 1-repetition-maximum, with measures taken during a task-specific isometric squat (IS) and non-specific isometric knee extension (KE']","['task-specific increase in IS MVC', 'maximum voluntary contraction (MVC', 'spinal excitability', 'corticospinal responses', 'muscle thickness', 'repetition maximum squat']","[{'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0241236', 'cui_str': 'Does squat'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0205370', 'cui_str': 'Non-specific'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0231448', 'cui_str': 'Extension'}]","[{'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0241236', 'cui_str': 'Does squat'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}, {'cui': 'C0235169', 'cui_str': 'Excitability'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}]",18.0,0.0239771,"A single bout of resistance training increased spinal excitability, however no changes in corticospinal responses were noted following 4 weeks of squat training despite task-specific increases in strength.","[{'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Ansdell', 'Affiliation': 'Faculty of Health and Life Sciences, Northumbria University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Callum G', 'Initials': 'CG', 'LastName': 'Brownstein', 'Affiliation': 'Faculty of Health and Life Sciences, Northumbria University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Jakob', 'Initials': 'J', 'LastName': 'Škarabot', 'Affiliation': 'Faculty of Health and Life Sciences, Northumbria University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Angius', 'Affiliation': 'Faculty of Health and Life Sciences, Northumbria University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Dawson', 'Initials': 'D', 'LastName': 'Kidgell', 'Affiliation': 'Department of Physiotherapy, School of Primary and Allied Health Care, Faculty of Medicine, Nursing and Health Sciences, Monash University, Melbourne, Australia.'}, {'ForeName': 'Ashlyn', 'Initials': 'A', 'LastName': 'Frazer', 'Affiliation': 'Department of Physiotherapy, School of Primary and Allied Health Care, Faculty of Medicine, Nursing and Health Sciences, Monash University, Melbourne, Australia.'}, {'ForeName': 'Kirsty M', 'Initials': 'KM', 'LastName': 'Hicks', 'Affiliation': 'Faculty of Health and Life Sciences, Northumbria University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Rade', 'Initials': 'R', 'LastName': 'Durbaba', 'Affiliation': 'Faculty of Health and Life Sciences, Northumbria University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Glyn', 'Initials': 'G', 'LastName': 'Howatson', 'Affiliation': 'Faculty of Health and Life Sciences, Northumbria University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'Goodall', 'Affiliation': 'Faculty of Health and Life Sciences, Northumbria University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Thomas', 'Affiliation': 'Faculty of Health and Life Sciences, Northumbria University, Newcastle upon Tyne, UK.'}]",Experimental physiology,['10.1113/EP088629'] 53,32361843,Percutaneous vertebroplasty and balloon kyphoplasty in the treatment of osteoporotic vertebral fractures: a prospective randomized comparison.,"PURPOSE The purpose of this study is to compare the efficacy and safety of percutaneous vertebroplasty (PVP) and balloon kyphoplasty (BKP) in the treatment of osteoporotic vertebral compression fractures. MATERIALS AND METHODS Patients with osteoporotic vertebral body fractures (T4-L5) were randomized and not blinded to kyphoplasty (n = 69) or vertebroplasty (n = 70). The postoperative pain score (VAS) at 12 months was the primary end point. The radiographic results were evaluated in relation to the resolution of the fracture and the possible onset of further osteoporotic fractures during follow-up. RESULTS A total of one hundred and thirty-nine patients were eligible for randomization (n = 70 for PVP group and n = 69 for BKP), and twenty-six patients (twenty in the BKP group and six in the PVP group) were excluded. The mean average age of patients was 73 years, and 82% of the patients were females. VAS pain score was significantly reduced after surgery in both groups, and there were no significant differences between the two groups in postoperative VAS score. There was a significant reduction in kyphotic wedge angle and improvement of the sagittal index in both groups, but there was no significant difference between the two groups. There was a significant higher risk incidence of adjacent level fractures in the vertebroplasty group. CONCLUSIONS In terms of clinical outcomes, there were no differences between the two groups. Both showed a significant clinical improvement, vertebral body height restoration and reduction in the kyphotic angle. There was a significant higher risk of adjacent level fractures in the vertebroplasty group.",2020,"VAS pain score was significantly reduced after surgery in both groups, and there were no significant differences between the two groups in postoperative VAS score.","['osteoporotic vertebral compression fractures', 'A total of one hundred and thirty-nine patients were eligible for randomization (n\u2009=\u200970 for PVP group and n\u2009=\u200969 for BKP), and twenty-six patients (twenty in the BKP group and six in the PVP group) were excluded', 'Patients with osteoporotic vertebral body fractures (T4-L5', 'osteoporotic vertebral fractures']","['percutaneous vertebroplasty (PVP) and balloon kyphoplasty (BKP', 'Percutaneous vertebroplasty and balloon kyphoplasty', 'vertebroplasty']","['VAS pain score', 'postoperative pain score (VAS', 'risk of adjacent level fractures', 'kyphotic wedge angle and improvement of the sagittal index', 'vertebral body height restoration and reduction in the kyphotic angle', 'postoperative VAS score', 'risk incidence of adjacent level fractures']","[{'cui': 'C0262431', 'cui_str': 'Compression fracture of vertebral column'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C5191072', 'cui_str': '139'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C1303192', 'cui_str': 'Vertebroplasty'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft'}, {'cui': 'C1455863', 'cui_str': 'Balloon Vertebroplasty'}, {'cui': 'C0450349', 'cui_str': '26'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0223084', 'cui_str': 'Structure of body of vertebra'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0080179', 'cui_str': 'Fracture of vertebral column'}]","[{'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C1303192', 'cui_str': 'Vertebroplasty'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft'}, {'cui': 'C1455863', 'cui_str': 'Balloon Vertebroplasty'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205117', 'cui_str': 'Juxta-posed'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0454239', 'cui_str': 'Wedge angle'}, {'cui': 'C0205129', 'cui_str': 'Sagittal'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0223084', 'cui_str': 'Structure of body of vertebra'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",139.0,0.0214834,"VAS pain score was significantly reduced after surgery in both groups, and there were no significant differences between the two groups in postoperative VAS score.","[{'ForeName': 'C', 'Initials': 'C', 'LastName': 'Griffoni', 'Affiliation': 'Department of Oncological and Degenerative Spine Surgery, IRCCS Istituto Ortopedico Rizzoli, Via G.C. Pupilli, 1, 40136, Bologna, Italy.'}, {'ForeName': 'J N M', 'Initials': 'JNM', 'LastName': 'Lukassen', 'Affiliation': 'Department of Neurosurgery, University Medical Centre Groningen, Groningen, The Netherlands.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Babbi', 'Affiliation': 'GSpine4, IRCCS Istituto Ortopedico Galeazzi, Milan, Italy.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Girolami', 'Affiliation': 'Department of Oncological and Degenerative Spine Surgery, IRCCS Istituto Ortopedico Rizzoli, Via G.C. Pupilli, 1, 40136, Bologna, Italy.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Lamartina', 'Affiliation': 'GSpine4, IRCCS Istituto Ortopedico Galeazzi, Milan, Italy.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Cecchinato', 'Affiliation': 'GSpine4, IRCCS Istituto Ortopedico Galeazzi, Milan, Italy.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Gasbarrini', 'Affiliation': 'Department of Oncological and Degenerative Spine Surgery, IRCCS Istituto Ortopedico Rizzoli, Via G.C. Pupilli, 1, 40136, Bologna, Italy.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Barbanti Brodano', 'Affiliation': 'Department of Oncological and Degenerative Spine Surgery, IRCCS Istituto Ortopedico Rizzoli, Via G.C. Pupilli, 1, 40136, Bologna, Italy. giovanni@barbantibrodano.com.'}]","European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society",['10.1007/s00586-020-06434-3'] 54,32363765,"Immediate vs conventional loading of Facility-Equator system in mandibular overdenture wearers: 1-year RCT with clinical, biological, and functional evaluation.","BACKGROUND The use of immediate loading (IML) is still poorly explored in elderly patients and implant-retained mandibular overdenture (IMO) wearers. For this reason, more comparisons to conventional loading (CL) are required. PURPOSE To evaluate the clinical, biological, functional, and oral health-related quality of life (OHRQOL) influence of CL and IML loading on elders wearing IMO retained by the Facility-Equator system up to 1 year after implant installation. MATERIAL AND METHODS Twenty edentulous patients received two narrow diameter implants in the mandible; the loading type (CL or IML) was randomized. The clinical parameters were monitored along with prosthetic events, marginal bone loss (MBL) and bone level change (BLC), implant stability quotients (ISQ), masticatory performance outcomes, and Interleukin 1 beta (IL-1β) and tumor necrosis factor alpha (TNF-α) levels in the peri-implant crevicular fluid during the first year of loading. The OHRQoL was assessed via the Oral Health Impact Profile-EDENT questionnaire. Data were analyzed by the Mann-Whitney, χ 2 , Wilcoxon paired, and McNemar tests. RESULTS After 1 year, MBL, BLC and ISQ were statistically identical (P > .05) in the CL and IML groups. The probing depth at 12 months in the CL group (2.19 mm) was higher than in the IML group (1.29 mm; P ≤ .0001). TNF-α was 33.6% higher in the CL group at 6 months (P = .043), while IL-1β was significantly higher in the IML group up to 6 months. The survival rate was 90% in the CL group and 85% in the IML group; 33 prosthetic events occurred in CL group and 23 in IML group. CONCLUSIONS After 12 months, both loading protocols are viable and result in similar clinical, biological, functional, and OHRQOL outcomes. However, IML generates better adaptation of the peri-implant tissues, faster improvement in OHRQoL and fewer prosthetic intercurrences than CL.",2020,"TNF-α was 33.6% higher in the CL group at 6 months (P = .043), while IL-1β was significantly higher in the IML group up to 6 months.","['elders wearing IMO retained by the Facility-Equator system up to 1\u2009year after implant installation', 'Twenty edentulous patients received two', 'elderly patients and implant-retained mandibular overdenture (IMO) wearers', 'mandibular overdenture wearers']","['narrow diameter implants in the mandible; the loading type (CL or IML', 'IML', 'CL and IML loading', 'conventional loading (CL', 'immediate loading (IML', 'Immediate vs conventional loading of Facility-Equator system']","['TNF-α', 'IL-1β', 'similar clinical, biological, functional, and OHRQOL outcomes', 'probing depth', 'MBL, BLC and ISQ', 'survival rate', 'prosthetic events, marginal bone loss (MBL) and bone level change (BLC), implant stability quotients (ISQ), masticatory performance outcomes, and Interleukin 1 beta (IL-1β) and tumor necrosis factor alpha (TNF-α) levels']","[{'cui': 'C0331055', 'cui_str': 'Genus Sambucus'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0333118', 'cui_str': 'Retained'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0011459', 'cui_str': 'Overlay denture'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0026644', 'cui_str': 'Edentulous'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0332463', 'cui_str': 'Narrowed structure'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0005515', 'cui_str': 'Biological agent'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0029453', 'cui_str': 'Osteopenia'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0021753', 'cui_str': 'interleukin-1, beta'}, {'cui': 'C1168005', 'cui_str': 'Alpha tumour necrosis factor'}]",20.0,0.0639622,"TNF-α was 33.6% higher in the CL group at 6 months (P = .043), while IL-1β was significantly higher in the IML group up to 6 months.","[{'ForeName': 'Alessandra J', 'Initials': 'AJ', 'LastName': 'Schuster', 'Affiliation': 'Graduate Program in Dentistry, School of Dentistry, Federal University of Pelotas, Rio Grande do Sul, Brazil.'}, {'ForeName': 'Raissa M', 'Initials': 'RM', 'LastName': 'Marcello-Machado', 'Affiliation': 'Department of Prosthodontics and Periodontology, Piracicaba Dental School, State University of Campinas, Piracicaba, São Paulo, Brazil.'}, {'ForeName': 'Amália M', 'Initials': 'AM', 'LastName': 'Bielemann', 'Affiliation': 'Graduate Program in Dentistry, School of Dentistry, Federal University of Pelotas, Rio Grande do Sul, Brazil.'}, {'ForeName': 'Anna Paula da Rosa', 'Initials': 'APDR', 'LastName': 'Possebon', 'Affiliation': 'Graduate Program in Dentistry, School of Dentistry, Federal University of Pelotas, Rio Grande do Sul, Brazil.'}, {'ForeName': 'Otacílio L', 'Initials': 'OL', 'LastName': 'Chagas Júnior', 'Affiliation': 'Department of Oral and Maxillofacial Surgery and Maxillofacial Prosthodontics, School of Dentistry, Federal University of Pelotas, Pelotas, Rio Grande do Sul, Brazil.'}, {'ForeName': 'Fernanda', 'Initials': 'F', 'LastName': 'Faot', 'Affiliation': 'Department of Restorative Dentistry, School of Dentistry, Federal University of Pelotas, Pelotas, Rio Grande do Sul, Brazil.'}]",Clinical implant dentistry and related research,['10.1111/cid.12902'] 55,32372651,"The effectiveness of Kinesio Taping ® for mobility and functioning improvement in knee osteoarthritis: a randomized, double-blind, controlled trial.","OBJECTIVE To evaluate the effectiveness of the Kinesio Taping ® method for mobility and functioning improvement for patients with knee osteoarthritis (KO). DESIGN Randomized, double-blinded, controlled trial. SETTING Outpatient rehabilitation department. SUBJECTS A total of 187 subjects with symptomatic I-III grade KO participated; of these, 157 subjects were included in the analyses (intervention group, n  = 81 (123 knees); control group, n  = 76 (114 knees). INTERVENTION The intervention group received a specific Kinesio Taping application, and the control group received non-specific knee taping for a month. MAIN MEASURES Changes in Knee injury and Osteoarthritis Outcome Scores (KOOS), knee active range of motion, 10-Meter Walk, and the five times sit to stand tests (5xSST) were assessed at baseline, after four weeks of taping, and a month post taping intervention. Subjective participants' experiences and opinions on the effect of knee taping were evaluated. The chosen level of significance was p  < 0.05. RESULTS The mean age of participants was 68.7 ± 9.9 in intervention group and 70.6 ± 8.3 in control group ( p  > 0.05). The change from baseline in gait speed in the intervention group after taping month was +0.04 ± 0.1 m/s, at follow-up +0.06 ± 0.1 m/s; in control group +0.07 ± 0.1 m/s, and +0.09 ± 0.1 m/s; the change in time needed to accomplish 5xSST was -2.2 ± 3.2 seconds, at follow-up -2.4 ± 3.1 seconds; in control group -2.8 ± 3.6 seconds, and -2.4 ± 4 seconds. Improved knee flexion and enhancement in functioning assessed by KOOS were noticed in both groups, with lasting improvement to follow up. No difference in the change in the above-mentioned outcomes was found between groups ( p  > 0.05). Fewer subjects (6.2% (5) vs. 21.1% (16), χ 2  = 7.5, df  = 2, p  = 0.024) from Kinesio Taping group were unsure if taping alleviated their mobility and more intervention group patients indicated higher subjective satisfaction with the effect of knee taping to symptom and mobility alleviation than control group ( p  < 0.005). CONCLUSION Investigated Kinesio Taping technique did not produce better results in mobility and functioning improvement over non-specific knee taping; however, it had higher patient-reported subjective value for symptom attenuation and experienced mobility enhancement.",2020,"Investigated Kinesio Taping technique did not produce better results in mobility and functioning improvement over non-specific knee taping; however, it had higher patient-reported subjective value for symptom attenuation and experienced mobility enhancement.","['knee osteoarthritis', 'Outpatient rehabilitation department', '187 subjects with symptomatic I-III grade KO participated; of these, 157 subjects were included in the analyses (intervention group, n \u2009=\u200981 (123 knees); control group, n\u2009 =\u200976 (114 knees', 'patients with knee osteoarthritis (KO']","['Kinesio Taping technique', 'Kinesio Taping ®', 'specific Kinesio Taping application, and the control group received non-specific knee taping for a month', 'Kinesio Taping ® method']","['Knee injury and Osteoarthritis Outcome Scores (KOOS), knee active range of motion, 10-Meter Walk, and the five times sit to stand tests (5xSST', 'gait speed', 'subjective satisfaction', 'mobility and functioning improvement', 'knee flexion and enhancement in functioning assessed by KOOS', 'knee taping to symptom and mobility alleviation']","[{'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0587478', 'cui_str': 'Rehabilitation department'}, {'cui': 'C4517618', 'cui_str': '187'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4708785', 'cui_str': '114'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0034115', 'cui_str': 'Centesis'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205370', 'cui_str': 'Non-specific'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0025663', 'cui_str': 'Method'}]","[{'cui': 'C3476088', 'cui_str': 'Knee Injury and Osteoarthritis Outcome Score'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0441074', 'cui_str': 'Meters'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0560801', 'cui_str': 'Does stand from sitting'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C1627358', 'cui_str': 'Refractive surgery enhancement'}, {'cui': 'C0034115', 'cui_str': 'Centesis'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",187.0,0.0909194,"Investigated Kinesio Taping technique did not produce better results in mobility and functioning improvement over non-specific knee taping; however, it had higher patient-reported subjective value for symptom attenuation and experienced mobility enhancement.","[{'ForeName': 'Venta', 'Initials': 'V', 'LastName': 'Donec', 'Affiliation': 'Department of Rehabilitation, Medical Academy, Lithuanian University of Health Sciences, Kaunas, Lithuania.'}, {'ForeName': 'Raimondas', 'Initials': 'R', 'LastName': 'Kubilius', 'Affiliation': 'Department of Rehabilitation, Medical Academy, Lithuanian University of Health Sciences, Kaunas, Lithuania.'}]",Clinical rehabilitation,['10.1177/0269215520916859'] 56,32369401,Randomized Trial of Text Messaging to Reduce Early Discontinuation of Adjuvant Aromatase Inhibitor Therapy in Women With Early-Stage Breast Cancer: SWOG S1105.,"PURPOSE Nonadherence to aromatase inhibitors (AIs) for breast cancer is common and increases the risk of recurrence. Text messaging increases adherence to medications for chronic conditions. METHODS We conducted a randomized clinical trial of text messaging (TM) versus no text messaging (No-TM) at 40 sites in the United States. Eligible patients were postmenopausal women with early-stage breast cancer taking an AI for > 30 days with a planned duration of ≥ 36 months. Test messages were sent twice a week over 36 months. Content themes focused on overcoming barriers to medication adherence and included cues to action, statements related to medication efficacy, and reinforcements of the recommendation to take AIs. Both groups were assessed every 3 months. The primary outcome was time to adherence failure (AF), where AF was defined as urine AI metabolite assay results satisfying one of the following: < 10 ng/mL, undetectable, or no submitted specimen. A stratified log-rank test was conducted. Multiple sensitivity analyses were performed. RESULTS In total, 724 patients were registered between May 2012 and September 2013, among whom,702 patients (348 in the text-messaging arm and 354 in the no-text-messaging arm) were eligible at baseline. Observed adherence at 36 months was 55.5% for TM and 55.4% for No-TM. The primary analysis showed no difference in time to AF by arm (3-year AF: 81.9% TM v 85.6% No-TM; HR, 0.89 [95% CI, 0.76 to 1.05]; P = .18). Multiple time to AF sensitivity analyses showed similar nonsignificant results. Three-year self-reported time to AF (10.4% v 10.3%; HR, 1.16 [95% CI, 0.69 to 1.98]; P = .57) and site-reported time to AF (21.9% v 18.9%; HR, 1.31 [95% CI, 0.86 to 2.01]; P = .21) also did not differ by arm. CONCLUSION To our knowledge, this was the first large, long-term, randomized trial of an intervention directed at improving AI adherence. We found high rates of AI AF. Twice-weekly text reminders did not improve adherence to AIs. Improving long-term adherence will likely require personalized and sustained behavioral interventions.",2020,"The primary analysis showed no difference in time to AF by arm (3-year AF: 81.9% TM v 85.6% No-TM; HR, 0.89 [95% CI, 0.76 to 1.05]; P = .18).","['Eligible patients were postmenopausal women with early-stage breast cancer taking an AI for > 30 days with a planned duration of ≥ 36 months', 'Women', '724 patients were registered between May 2012 and September 2013, among whom,702 patients (348 in the text-messaging arm and 354 in the no-text-messaging arm) were eligible at baseline']","['text messaging (TM) versus no text messaging (No-TM', 'Adjuvant Aromatase Inhibitor Therapy', 'Text Messaging']","['time to AF', 'time to adherence failure (AF', 'rates of AI AF']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C4517733', 'cui_str': '348'}, {'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]","[{'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0593802', 'cui_str': 'Aromatase inhibitor'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0231174', 'cui_str': 'Failure'}]",724.0,0.166451,"The primary analysis showed no difference in time to AF by arm (3-year AF: 81.9% TM v 85.6% No-TM; HR, 0.89 [95% CI, 0.76 to 1.05]; P = .18).","[{'ForeName': 'Dawn L', 'Initials': 'DL', 'LastName': 'Hershman', 'Affiliation': 'Columbia University Medical Center, New York, NY.'}, {'ForeName': 'Joseph M', 'Initials': 'JM', 'LastName': 'Unger', 'Affiliation': 'SWOG Statistics and Data Management Center, Seattle, WA.'}, {'ForeName': 'Grace Clarke', 'Initials': 'GC', 'LastName': 'Hillyer', 'Affiliation': 'Columbia University Medical Center, New York, NY.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Moseley', 'Affiliation': 'SWOG Statistics and Data Management Center, Seattle, WA.'}, {'ForeName': 'Kathryn B', 'Initials': 'KB', 'LastName': 'Arnold', 'Affiliation': 'SWOG Statistics and Data Management Center, Seattle, WA.'}, {'ForeName': 'Shaker R', 'Initials': 'SR', 'LastName': 'Dakhil', 'Affiliation': 'Wichita NCORP/Cancer Center of Kansas - Wichita, Wichita, KS.'}, {'ForeName': 'Benjamin T', 'Initials': 'BT', 'LastName': 'Esparaz', 'Affiliation': 'Heartland NCORP/Cancer Care Specialist of Central Illinois, Decatur, IL.'}, {'ForeName': 'Ming C', 'Initials': 'MC', 'LastName': 'Kuan', 'Affiliation': 'Kaiser Permanente NCORP/Kaiser Permanente NCAL, San Leandro, CA.'}, {'ForeName': 'Mark L', 'Initials': 'ML', 'LastName': 'Graham', 'Affiliation': 'Southeast COR NCORP/Waverly Hematology/Oncology, Cary, NC.'}, {'ForeName': 'Douglas M', 'Initials': 'DM', 'LastName': 'Lackowski', 'Affiliation': 'Northwest NCORP/Central Interstate Medical Office Department Hematology/Oncology, Portland, OR.'}, {'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Edenfield', 'Affiliation': 'NCORP of the Carolinas (Greenville Health System), Greenville, SC.'}, {'ForeName': 'Zoneddy R', 'Initials': 'ZR', 'LastName': 'Dayao', 'Affiliation': 'New Mexico Minority Underserved NCORP/University of New Mexico Cancer Center, Albuquerque, NM.'}, {'ForeName': 'N Lynn', 'Initials': 'NL', 'LastName': 'Henry', 'Affiliation': 'University of Michigan, Ann Arbor, MI.'}, {'ForeName': 'Julie R', 'Initials': 'JR', 'LastName': 'Gralow', 'Affiliation': 'Seattle Cancer Care Alliance/University of Washington, Seattle, WA.'}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Ramsey', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Seattle, WA.'}, {'ForeName': 'Alfred I', 'Initials': 'AI', 'LastName': 'Neugut', 'Affiliation': 'Columbia University Medical Center, New York, NY.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.02699'] 57,32369655,Randomized double-blind vehicle controlled study of the effects of topical acetyl zingerone on photoaging.,"OBJECTIVE Acetyl zingerone (AZ), a derivative of the phytochemical zingerone from Zingiber officinale (ginger), is a novel compound that is purported to have antiaging properties. The objective of this clinical study was to assess the role of acetyl zingerone in its ability to improve the appearance of facial skin wrinkles, redness, pigmentation, and photoaging was assessed. METHODS Thirty-one healthy participants (age 44 ± 7 years) were randomized in blinded fashion to apply either 1% AZ or placebo, consisting of the vehicle base cream, to the full face twice daily for 8 weeks with a total of 3 visits. Signs of photoaging, including wrinkles, dyspigmentation, and redness were assessed with facial image analysis photography and software. RESULTS There was a significant decrease in average wrinkle severity (P = .019; Mean=-25.7% change), total wrinkle volume (P = .003; Mean=-30.1% change), pigment intensity (P = .021; Mean=-25.6% change), and redness intensity (P = .035; Mean=-20.7% change) in the AZ group by 8 weeks compared with the placebo. No significant itching, burning, or stinging was noted by study participants. There was also no significant difference between both groups in the clinical assessment of scaling, erythema, hypopigmentation, or hyperpigmentation. CONCLUSIONS AND RELEVANCE Topical AZ improves photodamage and decreases the appearance of wrinkles, dyspigmentation, and redness intensity when compared to placebo (vehicle) formulation. Acetyl zingerone is well tolerated with daily use.",2020,"There was a significant decrease in average wrinkle severity (p=0.019; Mean=-25.7% change), total wrinkle volume (p=0.003; Mean=-30.1 % change), pigment intensity (p=0.021; Mean=-25.6% change), and redness intensity (p=0.035; Mean=-20.7% change) in the AZ group by 8 weeks compared to the placebo.",['Thirty-one healthy participants (age 44 ± 7 years'],"['Acetyl zingerone (AZ', 'AZ or placebo', 'Topical Acetyl Zingerone', 'Acetyl zingerone', 'placebo']","['average wrinkle severity', 'itching, burning, or stinging', 'redness intensity', 'Photoaging', 'Signs of photoaging, including wrinkles, dyspigmentation, and redness', 'clinical assessment of scaling, erythema, hypopigmentation, or hyperpigmentation', 'total wrinkle volume', 'appearance of facial skin wrinkles, redness, pigmentation, and photoaging', 'appearance of wrinkles, dyspigmentation, and redness intensity', 'pigment intensity']","[{'cui': 'C0450355', 'cui_str': '31'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0078809', 'cui_str': 'zingerone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332237', 'cui_str': 'Topical'}]","[{'cui': 'C0037301', 'cui_str': 'Wrinkled skin'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C0000912', 'cui_str': 'Accident caused by unspecified fire'}, {'cui': 'C0677500', 'cui_str': 'Stinging'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1260926', 'cui_str': 'Abnormal pigmentation'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0162835', 'cui_str': 'Hypopigmentation'}, {'cui': 'C0162834', 'cui_str': 'Hyperpigmentation'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0222084', 'cui_str': 'Skin structure of face'}, {'cui': 'C0031911', 'cui_str': 'Pigmentation'}]",31.0,0.321772,"There was a significant decrease in average wrinkle severity (p=0.019; Mean=-25.7% change), total wrinkle volume (p=0.003; Mean=-30.1 % change), pigment intensity (p=0.021; Mean=-25.6% change), and redness intensity (p=0.035; Mean=-20.7% change) in the AZ group by 8 weeks compared to the placebo.","[{'ForeName': 'Simran', 'Initials': 'S', 'LastName': 'Dhaliwal', 'Affiliation': 'Department of Dermatology, University of California-Davis, Sacramento, California, USA.'}, {'ForeName': 'Iryna', 'Initials': 'I', 'LastName': 'Rybak', 'Affiliation': 'Department of Dermatology, University of California-Davis, Sacramento, California, USA.'}, {'ForeName': 'Aunna', 'Initials': 'A', 'LastName': 'Pourang', 'Affiliation': 'Department of Dermatology, University of California-Davis, Sacramento, California, USA.'}, {'ForeName': 'Waqas', 'Initials': 'W', 'LastName': 'Burney', 'Affiliation': 'Department of Dermatology, University of California-Davis, Sacramento, California, USA.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Haas', 'Affiliation': 'Department of Dermatology, University of California-Davis, Sacramento, California, USA.'}, {'ForeName': 'Simran', 'Initials': 'S', 'LastName': 'Sandhu', 'Affiliation': 'School of Medicine, University of California-Davis, Sacramento, California, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Crawford', 'Affiliation': 'Department of Biological Sciences, California State University, Sacramento, California, USA.'}, {'ForeName': 'Raja', 'Initials': 'R', 'LastName': 'K Sivamani', 'Affiliation': 'Department of Dermatology, University of California-Davis, Sacramento, California, USA.'}]",Journal of cosmetic dermatology,['10.1111/jocd.13464'] 58,32379201,Influenza or Meningococcal Immunization During Pregnancy and Mortality in Women and Infants: A Pooled Analysis of Randomized Controlled Trials.,"This analysis includes pooled data from 2 placebo-controlled maternal influenza immunization trials, with a separate analysis on a meningococcal conjugate vaccine-controlled maternal influenza immunization trial. Maternal influenza immunization was not associated with infant or maternal all-cause mortality in placebo-controlled trials. In the meningococcal conjugate vaccine-controlled trial, there were fewer deaths during low or any influenza circulation weeks among infants whose mothers received meningococcal conjugate vaccine. ClinicalTrials.gov identifiers: NCT01430689, NCT01034254 and NCT02465190.",2020,"In the meningococcal conjugate vaccine-controlled trial, there were fewer deaths during low or any influenza circulation weeks among infants whose mothers received meningococcal conjugate vaccine.",['Women and Infants'],"['Influenza or Meningococcal Immunization', 'meningococcal conjugate vaccine']",['Maternal influenza immunization'],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0021270', 'cui_str': 'Infant'}]","[{'cui': 'C0021400', 'cui_str': 'Influenza'}, {'cui': 'C3888669', 'cui_str': 'Meningococcal immunisation'}, {'cui': 'C1660580', 'cui_str': 'Meningococcal conjugate vaccine'}]","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0042200', 'cui_str': 'Influenza vaccination'}]",,0.546968,"In the meningococcal conjugate vaccine-controlled trial, there were fewer deaths during low or any influenza circulation weeks among infants whose mothers received meningococcal conjugate vaccine.","[{'ForeName': 'Dayna R', 'Initials': 'DR', 'LastName': 'Clark', 'Affiliation': 'From the Department of Epidemiology, Emory University Rollins School of Public Health, Atlanta, GA.'}, {'ForeName': 'Saad B', 'Initials': 'SB', 'LastName': 'Omer', 'Affiliation': 'Yale Institute for Global Health.'}, {'ForeName': 'Milagritos D', 'Initials': 'MD', 'LastName': 'Tapia', 'Affiliation': 'Centre pour le Développement des Vaccins, Bamako, Mali.'}, {'ForeName': 'Marta C', 'Initials': 'MC', 'LastName': 'Nunes', 'Affiliation': 'Medical Research Council: Respiratory and Meningeal Pathogens Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Clare L', 'Initials': 'CL', 'LastName': 'Cutland', 'Affiliation': 'Medical Research Council: Respiratory and Meningeal Pathogens Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'James M', 'Initials': 'JM', 'LastName': 'Tielsch', 'Affiliation': 'Department of Global Health, Milken Institute School of Public Health, George Washington University, Washington, Columbia.'}, {'ForeName': 'Niteen', 'Initials': 'N', 'LastName': 'Wairagkar', 'Affiliation': 'Bill & Melinda Gates Foundation, Seattle, WA.'}, {'ForeName': 'Shabir A', 'Initials': 'SA', 'LastName': 'Madhi', 'Affiliation': 'Medical Research Council: Respiratory and Meningeal Pathogens Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Pediatric infectious disease journal,['10.1097/INF.0000000000002629'] 59,32371165,Safety and Efficacy of Tumor Necrosis Factor Antagonists in Older Patients With Ulcerative Colitis: Patient-Level Pooled Analysis of Data From Randomized Trials.,"BACKGROUND & AIMS Treatment of older patients (more than 60 years) with ulcerative colitis (UC) can be a challenge, because they might be more vulnerable to adverse events (AEs). We determined the effects of age on the safety and efficacy of anti-tumor necrosis factor (TNF) therapy in a pooled analysis of data from randomized trials. METHODS We obtained individual patient-level data from 4 trials of anti-TNF therapy for patients with UC from the Yale Open Data Access Project. Participants were assigned to groups of older age (60 years or older) and younger age (younger than 60 years). The primary outcome was difference in serious AEs (SAEs), defined as death, life-threatening event, hospitalization, and/or significant disability. Secondary outcomes were severe infections, non-severe infections, neoplasms, and achievement of clinical remission, defined by trial investigators as Mayo score ≤ 2 with no sub-score >1 at the end of induction or maintenance therapy. A random effects logistic regression model was fitted to estimate the effect of anti-TNF therapy on safety and efficacy by age, adjusting for confounders and trial-level effects. RESULTS The study cohort included 2257 patients (231 60 years or older). Higher proportions of older patients receiving anti-TNF therapy had SAEs (20%) and hospitalizations (14.4%), compared with younger patients (10.2% had SAEs and 5.2% were hospitalized); there were no significant differences between groups in proportions with severe or non-severe infections. Compared with placebo, there was no significant difference in safety risks associated with anti-TNF therapy (SAEs reduced by 5.4% in older patients vs reduction of 2.4% in younger patients; hospitalizations reduced by 6.7% in older patients vs reduction of 2.5% in younger patients; severe infections reduced by 3.1% vs increase of 0.7% in younger patients). There was no significant difference in between older vs younger patients in efficacy of anti-TNF therapy in inducing remission (odds risk ratio, 1.05, 95% CI, 0.33-3.39) or in maintaining remission (odds risk ratio, 0.49; 95% CI, 0.18-1.33). CONCLUSIONS In a pooled analysis of data from randomized trials, we found that older patients with UC have an increased baseline increased risk of SAEs, but no increase in risk can be attributed to anti-TNF therapy in older vs younger patients.",2020,"There was no significant difference in between older vs younger patients in efficacy of anti-TNF therapy in inducing remission (odds risk ratio, 1.05, 95% CI, 0.33-3.39) or in maintaining remission (odds risk ratio, 0.49; 95% CI, 0.18-1.33). ","['Participants were assigned to groups of older age (60 years or older) and younger age (younger than 60 years', 'Older Patients', 'patients with UC from the Yale Open Data Access Project', '2257 patients (231 60 years or older', 'older patients with UC', 'older patients (more than 60 years) with ulcerative colitis (UC', 'With Ulcerative Colitis']","['anti-TNF therapy', 'Tumor Necrosis Factor Antagonists', 'anti-tumor necrosis factor (TNF) therapy', 'placebo']","['proportions with severe or non-severe infections', 'severe infections, non-severe infections, neoplasms, and achievement of clinical remission, defined by trial investigators as Mayo score ≤ 2 with no sub-score >1 at the end of induction or maintenance therapy', 'severe infections', 'risk of SAEs', 'serious AEs (SAEs), defined as death, life-threatening event, hospitalization, and/or significant disability', 'safety and efficacy', 'safety risks associated with anti-TNF therapy (SAEs']","[{'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0231337', 'cui_str': 'Senility'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009324', 'cui_str': 'Ulcerative colitis'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0016538', 'cui_str': 'Projections and Predictions'}, {'cui': 'C0439093', 'cui_str': '>'}]","[{'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C3537192', 'cui_str': 'TNF Antagonists'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0454788', 'cui_str': 'Mayo'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C4280965', 'cui_str': 'Greater than one'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0677908', 'cui_str': 'Maintenance therapy'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C3537125', 'cui_str': 'Common terminology criteria for adverse events grade 4'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]",2257.0,0.224528,"There was no significant difference in between older vs younger patients in efficacy of anti-TNF therapy in inducing remission (odds risk ratio, 1.05, 95% CI, 0.33-3.39) or in maintaining remission (odds risk ratio, 0.49; 95% CI, 0.18-1.33). ","[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Cheng', 'Affiliation': 'Harvard T.H. Chan School of Public Health, Boston, Massachusetts; Massachusetts General Hospital, Division of Gastroenterology, Boston, Massachusetts.'}, {'ForeName': 'Kelly C', 'Initials': 'KC', 'LastName': 'Cushing', 'Affiliation': 'Massachusetts General Hospital, Division of Gastroenterology, Boston, Massachusetts; Harvard University, Boston, Massachusetts; University of Michigan, Division of Gastroenterology, Ann Arbor, Michigan.'}, {'ForeName': 'Tianxi', 'Initials': 'T', 'LastName': 'Cai', 'Affiliation': 'Harvard T.H. Chan School of Public Health, Boston, Massachusetts; Massachusetts General Hospital, Division of Gastroenterology, Boston, Massachusetts.'}, {'ForeName': 'Ashwin N', 'Initials': 'AN', 'LastName': 'Ananthakrishnan', 'Affiliation': 'Massachusetts General Hospital, Division of Gastroenterology, Boston, Massachusetts; Harvard University, Boston, Massachusetts. Electronic address: aananthakrishnan@mgh.harvard.edu.'}]",Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association,['10.1016/j.cgh.2020.04.070'] 60,32371553,Reasons for Not Attending Cervical Cancer Screening and Associated Factors in Rural Ethiopia.,"Social, economic, and cultural factors have been associated with the level of participation in cervical cancer screening programs. This study identified factors associated with nonparticipation in cervical cancer screening, as well as reasons for not attending, in the context of a population-based, cluster-randomized trial in Ethiopia. A total of 2,356 women aged 30 to 49 years in 22 clusters were invited to receive one of two screening approaches, namely human papillomavirus (HPV) self-sampling or visual inspection with acetic acid (VIA). Participants and nonparticipants were analyzed according to their sociodemographic and economic characteristics. Reasons were determined for the refusal of women to participate in either screening method. More women in the VIA arm compared to the HPV arm declined participation in the screening [adjusted OR (AOR) 3.5; 95% confidence interval (CI), 2.6-4.8]. Women who declined attending screening were more often living in rural areas (AOR = 2.0; 95% CI, 1.1-3.5) and were engaged in informal occupations (AOR = 1.6; 95% CI, 1.1-2.4). The majority of nonattendants perceived themselves to be at no risk of cervical cancer (83.1%). The main reasons given for not attending screening for both screening approaches were lack of time to attend screening, self-assertion of being healthy, and fear of screening. We found that perceived time constraints and the perception of being at no risk of getting the disease were the most important barriers to screening. Living in rural settings and informal occupation were also associated with lower participation. Offering a swift and convenient screening service could increase the participation of women in cervical cancer screening at the community level.",2020,The majority of nonattendants perceived themselves to be at no risk of cervical cancer (83.1%).,"['2,356 women aged 30 to 49 years in 22 clusters']","['screening approaches, namely human papillomavirus (HPV) self-sampling or visual inspection with acetic acid (VIA']",[],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}]","[{'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0199219', 'cui_str': 'Inspection'}, {'cui': 'C0000983', 'cui_str': 'Acetic Acid'}]",[],2356.0,0.0669526,The majority of nonattendants perceived themselves to be at no risk of cervical cancer (83.1%).,"[{'ForeName': 'Muluken', 'Initials': 'M', 'LastName': 'Gizaw', 'Affiliation': 'Department of Preventive Medicine, School of Public Health, Addis Ababa University, Addis Ababa, Ethiopia.'}, {'ForeName': 'Brhanu', 'Initials': 'B', 'LastName': 'Teka', 'Affiliation': 'Department of Microbiology, Immunology and Parasitology, School of Medicine, Addis Ababa University, Ethiopia.'}, {'ForeName': 'Friederike', 'Initials': 'F', 'LastName': 'Ruddies', 'Affiliation': 'Institute for Medical Epidemiology, Biometrics and Informatics, Martin-Luther-University, Halle-Wittenberg, Germany.'}, {'ForeName': 'Konjit', 'Initials': 'K', 'LastName': 'Kassahun', 'Affiliation': 'Pathfinder International, Ethiopia.'}, {'ForeName': 'Dawit', 'Initials': 'D', 'LastName': 'Worku', 'Affiliation': 'Department of Gynecology, School of Medicine, Addis Ababa University, Addis Ababa, Ethiopia.'}, {'ForeName': 'Alemayehu', 'Initials': 'A', 'LastName': 'Worku', 'Affiliation': 'Department of Preventive Medicine, School of Public Health, Addis Ababa University, Addis Ababa, Ethiopia.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Wienke', 'Affiliation': 'Institute for Medical Epidemiology, Biometrics and Informatics, Martin-Luther-University, Halle-Wittenberg, Germany.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Mikolajczyk', 'Affiliation': 'Institute for Medical Epidemiology, Biometrics and Informatics, Martin-Luther-University, Halle-Wittenberg, Germany.'}, {'ForeName': 'Ahmedin', 'Initials': 'A', 'LastName': 'Jemal', 'Affiliation': 'Department of Intramural Research, American Cancer Society, Atlanta, Georgia.'}, {'ForeName': 'Andreas M', 'Initials': 'AM', 'LastName': 'Kaufmann', 'Affiliation': 'Clinic for Gynecology, Charité-Universitätmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität Berlin and Berlin Institute of Health, Berlin, Germany.'}, {'ForeName': 'Tamrat', 'Initials': 'T', 'LastName': 'Abebe', 'Affiliation': 'Department of Microbiology, Immunology and Parasitology, School of Medicine, Addis Ababa University, Ethiopia.'}, {'ForeName': 'Adamu', 'Initials': 'A', 'LastName': 'Addissie', 'Affiliation': 'Department of Preventive Medicine, School of Public Health, Addis Ababa University, Addis Ababa, Ethiopia.'}, {'ForeName': 'Eva Johanna', 'Initials': 'EJ', 'LastName': 'Kantelhardt', 'Affiliation': 'Institute for Medical Epidemiology, Biometrics and Informatics, Martin-Luther-University, Halle-Wittenberg, Germany. eva.kantelhardt@uk-halle.de.'}]","Cancer prevention research (Philadelphia, Pa.)",['10.1158/1940-6207.CAPR-19-0485'] 61,32379396,Does the length of uniportal video-assisted thoracoscopic lobectomy affect postoperative pain? Results of a randomized controlled trial.,"BACKGROUND Uniportal video-assisted thoracoscopic surgery (VATS) lobectomy has become a common approach for the treatment of early stage lung cancer. Here, we aimed to establish whether the length of uniportal incision could affect postoperative pain and surgical outcomes in consecutive patients undergoing uniportal VATS lobectomy for early stage lung cancer. METHODS This was a unicenter Randomized Control Trial (NCT03218098). Consecutive patients undergoing uniportal VATS lobectomy for Stage I lung cancer were randomly assigned to a Small Incision group or Long Incision group in 1:1 ratio based on whether patients received a 4 cm or 8 cm incision. The endpoints were to compare the intergroup difference regarding (i) postoperative pain measured by brief pain inventory (BPI) questionnaire (first endpoint); (ii) operative time; (iii) length of chest drainage; (iv) length of hospital stay; (v) postoperative complications; and (vi) pulmonary functional status (secondary endpoints). RESULTS A total of 48 patients were eligible for the study. Four patients were excluded; the study population included 44 patients: 23 within the Small Incision group, and 21 within the Long Incision group. The 11 BPI scores between the two groups showed no significant difference. Small Incision group presented higher operative time than Long Incision group (138.69 vs. 112.14 minutes; P = 0.0001) while no significant differences were found regarding length of hospital stay (P = 0.95); respiratory complications (P = 0.92); FEV1% (P = 0.63), and 6-Minute Walking Test (P = 0.77). CONCLUSIONS A larger incision for uniportal VATS lobectomy significantly reduced the operative time due to better exposure of the anatomical structures without increasing postoperative pain or affecting the surgical outcome. KEY POINTS A larger incision for uniportal VATS lobectomy significantly reduced the operative time due to better exposure of the anatomical structures without increasing postoperative pain or affecting the surgical outcome. To perform a larger incision could be a valuable strategy, particularly in nonexpert hands or when the patient's anatomy or tumor size make exposure of anatomic structures through smaller incisions difficult.",2020,"Small Incision group presented higher operative time than Long Incision group (138.69 vs. 112.14 minutes; P = 0.0001) while no significant differences were found regarding length of hospital stay (P = 0.95); respiratory complications (P = 0.92); FEV1% (P = 0.63), and 6-Minute Walking Test (P = 0.77). ","['48 patients were eligible for the study', 'consecutive patients undergoing uniportal VATS lobectomy for early stage lung cancer', 'I lung cancer', 'early stage lung cancer', 'Consecutive patients undergoing uniportal VATS lobectomy for Stage', 'Four patients were excluded; the study population included 44 patients: 23 within the Small Incision group, and 21 within the Long Incision group']","['Small Incision group or Long Incision group in 1:1 ratio based on whether patients received a 4 cm or 8 cm incision', 'uniportal video-assisted thoracoscopic lobectomy', 'uniportal incision', 'Uniportal video-assisted thoracoscopic surgery (VATS) lobectomy']","['postoperative pain and surgical outcomes', 'respiratory complications', 'intergroup difference regarding (i) postoperative pain measured by brief pain inventory (BPI) questionnaire (first endpoint); (ii) operative time; (iii) length of chest drainage; (iv) length of hospital stay; (v) postoperative complications; and (vi) pulmonary functional status (secondary endpoints', '6-Minute Walking Test', 'length of hospital stay', 'operative time', '11 BPI scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4304660', 'cui_str': 'Uniportal VATS - video assisted thoracoscopic surgery'}, {'cui': 'C0023928', 'cui_str': 'Lobectomy'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205166', 'cui_str': 'Long'}]","[{'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0023928', 'cui_str': 'Lobectomy'}, {'cui': 'C4304660', 'cui_str': 'Uniportal VATS - video assisted thoracoscopic surgery'}, {'cui': 'C0752151', 'cui_str': 'Surgery, Thoracic, Video-Assisted'}]","[{'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0161818', 'cui_str': 'Respiratory complication'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C2732532', 'cui_str': 'Brief pain inventory score'}]",4.0,0.151599,"Small Incision group presented higher operative time than Long Incision group (138.69 vs. 112.14 minutes; P = 0.0001) while no significant differences were found regarding length of hospital stay (P = 0.95); respiratory complications (P = 0.92); FEV1% (P = 0.63), and 6-Minute Walking Test (P = 0.77). ","[{'ForeName': 'Cecilia', 'Initials': 'C', 'LastName': 'Menna', 'Affiliation': 'Division of Thoracic Surgery, Sant\'Andrea Hospital, University of Rome ""Sapienza"", Rome, Italy.'}, {'ForeName': 'Camilla', 'Initials': 'C', 'LastName': 'Poggi', 'Affiliation': 'Division of Thoracic Surgery, Policlinico Umberto I, University of Rome ""Sapienza"", Rome, Italy.'}, {'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Andreetti', 'Affiliation': 'Division of Thoracic Surgery, Sant\'Andrea Hospital, University of Rome ""Sapienza"", Rome, Italy.'}, {'ForeName': 'Giulio', 'Initials': 'G', 'LastName': 'Maurizi', 'Affiliation': 'Division of Thoracic Surgery, Sant\'Andrea Hospital, University of Rome ""Sapienza"", Rome, Italy.'}, {'ForeName': 'Anna Maria', 'Initials': 'AM', 'LastName': 'Ciccone', 'Affiliation': 'Division of Thoracic Surgery, Sant\'Andrea Hospital, University of Rome ""Sapienza"", Rome, Italy.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': ""D'Andrilli"", 'Affiliation': 'Division of Thoracic Surgery, Sant\'Andrea Hospital, University of Rome ""Sapienza"", Rome, Italy.'}, {'ForeName': 'Camilla', 'Initials': 'C', 'LastName': 'Vanni', 'Affiliation': 'Division of Thoracic Surgery, Sant\'Andrea Hospital, University of Rome ""Sapienza"", Rome, Italy.'}, {'ForeName': 'Anna Rita', 'Initials': 'AR', 'LastName': 'Vestri', 'Affiliation': 'Department of Public Health and Infectious Disease, University of Rome ""Sapienza"", Rome, Italy.'}, {'ForeName': 'Alfonso', 'Initials': 'A', 'LastName': 'Fiorelli', 'Affiliation': 'Thoracic surgery Unit, University of Campania Luigi Vanvitelli, Naples, Italy.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Santini', 'Affiliation': 'Thoracic surgery Unit, University of Campania Luigi Vanvitelli, Naples, Italy.'}, {'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Venuta', 'Affiliation': 'Division of Thoracic Surgery, Policlinico Umberto I, University of Rome ""Sapienza"", Rome, Italy.'}, {'ForeName': 'Erino Angelo', 'Initials': 'EA', 'LastName': 'Rendina', 'Affiliation': 'Division of Thoracic Surgery, Sant\'Andrea Hospital, University of Rome ""Sapienza"", Rome, Italy.'}, {'ForeName': 'Mohsen', 'Initials': 'M', 'LastName': 'Ibrahim', 'Affiliation': 'Division of Thoracic Surgery, Sant\'Andrea Hospital, University of Rome ""Sapienza"", Rome, Italy.'}]",Thoracic cancer,['10.1111/1759-7714.13291'] 62,32313503,"Remarkably High Efficacy of Cenobamate in Adults With Focal-Onset Seizures: A Double-Blind, Randomized, Placebo-Controlled Trial.",,2020,,['Adults With Focal-Onset Seizures'],"['Cenobamate', 'Placebo']",[],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0751495', 'cui_str': 'Partial seizure'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.770884,,"[{'ForeName': 'David G', 'Initials': 'DG', 'LastName': 'Vossler', 'Affiliation': ''}]",Epilepsy currents,['10.1177/1535759720903032'] 63,32379238,Intervention for Reducing Sleep Disturbances After a 12-Time Zone Transition.,"Hoshikawa, M, Uchida, S, and Dohi, M. Intervention for reducing sleep disturbances after a 12-time zone transition. J Strength Cond Res 34(7): 1803-1807, 2020-The purpose of this study was to examine the effect of an intervention consisting of bright light exposure, sleep schedule shifts, and ramelteon on sleep disturbances after a transition of 12 time zones. Two groups, which flew from Tokyo to Rio, participated in this study. The experimental group received the treatment, whereas the control group did not receive any treatment. The experimental group members were exposed to bright light at night and their sleep-wake schedules were gradually delayed for 4 days before their flight. They also took 8 mg of ramelteon once a day for 5 days from the day of their first flight. Both groups departed Tokyo at 14:05, transiting through Frankfurt and arriving in Rio at 05:05. In Rio, it was recommended that they go to bed earlier than usual if they experienced sleepiness. Nocturnal sleep variables measured by wristwatch actigraphy and subjective morning tiredness were compared between groups. Statistical analysis revealed shorter sleep onset latencies (SOLs) in the experimental group (p < 0.01). The SOLs in Rio were 7.7 ± 2.5 minutes for the experimental group and 16.3 ± 3.7 minutes for the control group (d = 0.89, effect size: large). Sleep efficiency for the first 3 nights in Rio was 88.5 ± 1.2% for the experimental group and 82.9 ± 3.0% for the control group (p < 0.01, d = 1.09, effect size: large). These results suggest that the intervention reduced sleep disturbances in Rio. Our intervention may increase the options for conditioning methods for athletic events requiring time zone transitions.",2020,Statistical analysis revealed shorter sleep onset latencies (SOLs) in the experimental group (p < 0.01).,[],"['J Strength Cond Res XX(X', 'control group did not receive any treatment', 'bright light at night and their sleep-wake schedules']","['sleep disturbances', 'Sleep efficiency', 'Sleep Disturbances', 'Nocturnal sleep variables measured by wristwatch actigraphy and subjective morning tiredness', 'sleep onset latencies (SOLs']",[],"[{'cui': 'C1856054', 'cui_str': 'Hutterite cerebroosteonephrodysplasia syndrome'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0423899', 'cui_str': 'Above average intellect'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0442696', 'cui_str': 'Waking'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}]","[{'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C1171301', 'cui_str': 'Actigraphy'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0332170', 'cui_str': 'Morning'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C4505222', 'cui_str': 'Sleep Onset Latency'}]",,0.0180782,Statistical analysis revealed shorter sleep onset latencies (SOLs) in the experimental group (p < 0.01).,"[{'ForeName': 'Masako', 'Initials': 'M', 'LastName': 'Hoshikawa', 'Affiliation': 'Department of Sports Research, Japan Institute of Sports Sciences, Tokyo, Japan.'}, {'ForeName': 'Sunao', 'Initials': 'S', 'LastName': 'Uchida', 'Affiliation': 'Faculty of Sport Sciences, Waseda University, Mitakajima, Tokorozawa, Saitama, Japan.'}, {'ForeName': 'Michiko', 'Initials': 'M', 'LastName': 'Dohi', 'Affiliation': 'Sports Medical Center, Japan Institute of Sports Sciences, Tokyo, Japan.'}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000003640'] 64,32378273,"Effects of a cream containing madecassoside, 5% panthenol, and copper-zinc-manganese on improving postlaser resurfacing wound healing: A split-face, randomized trial.",,2020,,['post-laser resurfacing wound healing'],"['cream containing madecassoside, 5% panthenol, and copper-zinc-manganese']",[],"[{'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}]","[{'cui': 'C0700385', 'cui_str': 'Cream'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0297253', 'cui_str': 'madecassoside'}, {'cui': 'C1321598', 'cui_str': 'Panthenol'}, {'cui': 'C0009968', 'cui_str': 'Copper'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C0024706', 'cui_str': 'Manganese'}]",[],,0.0411193,,"[{'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'Department of Medical Cosmetology, Shanghai Dermatology Hospital, Shanghai, China.'}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Yu', 'Affiliation': ""L'Oreal (China) Co., Ltd., Shanghai, China.""}, {'ForeName': 'Zhong', 'Initials': 'Z', 'LastName': 'Shen', 'Affiliation': 'Department of Medical Cosmetology, Shanghai Dermatology Hospital, Shanghai, China.'}, {'ForeName': 'Zhongxing', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Department of Medical Cosmetology, Shanghai Dermatology Hospital, Shanghai, China.'}, {'ForeName': 'Caixia', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'Department of Medical Cosmetology, Shanghai Dermatology Hospital, Shanghai, China.'}, {'ForeName': 'Congying', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'Department of Medical Cosmetology, Shanghai Dermatology Hospital, Shanghai, China.'}, {'ForeName': 'Zongzhou', 'Initials': 'Z', 'LastName': 'Wu', 'Affiliation': 'Department of Medical Cosmetology, Shanghai Dermatology Hospital, Shanghai, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': 'Department of Medical Cosmetology, Shanghai Dermatology Hospital, Shanghai, China.'}]",Dermatologic therapy,['10.1111/dth.13533'] 65,32377773,Discoloration of surface sealants by plaque disclosing solution.,"PURPOSE Surface sealants are widely used as a prevention strategy and are indicated for young patients with insufficient oral hygiene who also need plaque removal by professional tooth cleaning. The aim of this study was to evaluate discoloration of surface sealants by plaque disclosing solutions and to test to what extent this discoloration can be reduced again by professional tooth cleaning. METHODS In all, 96 extracted lesion-free human teeth were randomly assigned to treatment with either Pro Seal® (PS; Opal Orthodontics, South Jordan, UT, USA) or Opal®Seal™ (OS; Reliance Orthodontic Products, Itasca, IL, USA). Color evaluations after application of the plaque disclosing solution Mira-2-Ton® (Hager & Werken, Duisburg, Germany) were performed using a clinical spectrophotometer. Staining and polishing were repeated once. Color differences (∆E) above 3.77 were regarded as clinically relevant. RESULTS All sealants showed high, clinically relevant ∆E values after the first staining. Polishing led to significantly decreased ∆E values on PS-treated teeth; however, the median ∆E value remained above the clinically relevant threshold. Polishing on OS-treated teeth only slightly reduced ∆E values. After professional tooth cleaning both PS and OS showed clinically relevant ∆E values. CONCLUSION Surface sealants show clinically relevant discoloration after exposure to plaque disclosing solution under in vitro conditions. Such discolorations could not be removed by professional tooth cleaning. Thus, in clinical practice, plaque disclosing solutions might cause esthetic deficits in surface sealant-treated teeth. The impact of plaque disclosing solutions under clinical conditions (e.g., in the presence of saliva and by various aspects of a person's nutrition) should be investigated in clinical studies.",2020,"Polishing led to significantly decreased ∆E values on PS-treated teeth; however, the median ∆E value remained above the clinically relevant threshold.","['young patients with insufficient oral hygiene who also need plaque removal by professional tooth cleaning', '96 extracted lesion-free human teeth']","['Pro Seal® (PS; Opal Orthodontics, South Jordan, UT, USA) or Opal®Seal']",['∆E values'],"[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205412', 'cui_str': 'Inadequate'}, {'cui': 'C0029164', 'cui_str': 'Dental Hygiene'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0542277', 'cui_str': 'Cleans drug injection equipment'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}]","[{'cui': 'C1570472', 'cui_str': 'Pro Seal'}, {'cui': 'C0084990', 'cui_str': 'VPDA protocol'}, {'cui': 'C0332276', 'cui_str': 'Orthodontic'}, {'cui': 'C0022418', 'cui_str': 'Jordan'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0036492', 'cui_str': 'Seal'}]","[{'cui': 'C1273875', 'cui_str': 'Values (community)'}]",96.0,0.0759057,"Polishing led to significantly decreased ∆E values on PS-treated teeth; however, the median ∆E value remained above the clinically relevant threshold.","[{'ForeName': 'Sinan', 'Initials': 'S', 'LastName': 'Şen', 'Affiliation': 'Department of Orthodontics and Dentofacial Orthopaedics, Dental School, University of Heidelberg, Im Neuenheimer Feld\xa0400, 69120, Heidelberg, Germany. sinan.sen@med.uni-heidelberg.de.'}, {'ForeName': 'Ralf', 'Initials': 'R', 'LastName': 'Erber', 'Affiliation': 'Department of Orthodontics and Dentofacial Orthopaedics, Dental School, University of Heidelberg, Im Neuenheimer Feld\xa0400, 69120, Heidelberg, Germany.'}, {'ForeName': 'Gözde', 'Initials': 'G', 'LastName': 'Şen', 'Affiliation': 'MVZ Dentale Praxisklinik, Dr. Dilling & Kollegen GmbH, Fleiner Straße\xa03, 74072, Heilbronn, Germany.'}, {'ForeName': 'Nadine', 'Initials': 'N', 'LastName': 'Deurer', 'Affiliation': 'Department of Orthodontics and Dentofacial Orthopaedics, Dental School, University of Heidelberg, Im Neuenheimer Feld\xa0400, 69120, Heidelberg, Germany.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Zingler', 'Affiliation': 'Department of Orthodontics and Dentofacial Orthopaedics, Dental School, University of Heidelberg, Im Neuenheimer Feld\xa0400, 69120, Heidelberg, Germany.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Lux', 'Affiliation': 'Department of Orthodontics and Dentofacial Orthopaedics, Dental School, University of Heidelberg, Im Neuenheimer Feld\xa0400, 69120, Heidelberg, Germany.'}]",Journal of orofacial orthopedics = Fortschritte der Kieferorthopadie : Organ/official journal Deutsche Gesellschaft fur Kieferorthopadie,['10.1007/s00056-020-00227-5'] 66,32376732,"Oral nitrate supplementation to enhance pulmonary rehabilitation in COPD: ON-EPIC a multicentre, double-blind, placebo-controlled, randomised parallel group study.","RATIONALE Dietary nitrate supplementation has been proposed as a strategy to improve exercise performance, both in healthy individuals and in people with COPD. We aimed to assess whether it could enhance the effect of pulmonary rehabilitation (PR) in COPD. METHODS This double-blind, placebo-controlled, parallel group, randomised controlled study performed at four UK centres, enrolled adults with Global Initiative for Chronic Obstructive Lung Disease grade II-IV COPD and Medical Research Council dyspnoea score 3-5 or functional limitation to undertake a twice weekly 8-week PR programme. They were randomly assigned (1:1) to either 140 mL of nitrate-rich beetroot juice (BRJ) (12.9 mmol nitrate), or placebo nitrate-deplete BRJ, consumed 3 hours prior to undertaking each PR session. Allocation used computer-generated block randomisation. MEASUREMENTS The primary outcome was change in incremental shuttle walk test (ISWT) distance. Secondary outcomes included quality of life, physical activity level, endothelial function via flow-mediated dilatation, fat-free mass index and blood pressure parameters. RESULTS 165 participants were recruited, 78 randomised to nitrate-rich BRJ and 87 randomised to placebo. Exercise capacity increased more with active treatment (n=57) than placebo (n=65); median (IQR) change in ISWT distance +60 m (10, 85) vs +30 m (0, 70), estimated treatment effect 30 m (95% CI 10 to 40); p=0.027. Active treatment also impacted on systolic blood pressure: treatment group -5.0 mm Hg (-5.0, -3.0) versus control +6.0 mm Hg (-1.0, 15.5), estimated treatment effect -7 mm Hg (95% CI 7 to -20) (p<0.0005). No significant serious adverse events or side effects were reported. CONCLUSIONS Dietary nitrate supplementation appears to be a well-tolerated and effective strategy to augment the benefits of PR in COPD. TRIAL REGISTRATION NUMBER ISRCTN27860457.",2020,"Exercise capacity increased more with active treatment (n=57) than placebo (n=65); median (IQR) change in ISWT distance +60 m (10, 85) vs +30 m (0, 70), estimated treatment effect 30 m (95% CI 10 to 40); p=0.027.","['healthy individuals and in people with COPD', '165 participants were recruited, 78 randomised to', 'COPD', 'four UK centres, enrolled adults with Global Initiative for Chronic Obstructive Lung Disease grade II-IV COPD and Medical Research Council dyspnoea score 3-5 or functional limitation to undertake a twice weekly 8-week PR programme']","['placebo', 'nitrate-rich BRJ', 'Oral nitrate supplementation', '140\u2009mL of nitrate-rich beetroot juice (BRJ) (12.9\u2009mmol nitrate), or placebo nitrate-deplete BRJ', 'pulmonary rehabilitation (PR']","['serious adverse events or side effects', 'Exercise capacity', 'quality of life, physical activity level, endothelial function via flow-mediated dilatation, fat-free mass index and blood pressure parameters', 'systolic blood pressure', 'incremental shuttle walk test (ISWT) distance', 'median (IQR) change in ISWT distance', 'exercise performance']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C4319555', 'cui_str': '165'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0424093', 'cui_str': 'Initiative'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0079816', 'cui_str': 'Research, Medical'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0442758', 'cui_str': '3/5'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0556985', 'cui_str': 'Twice weekly'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0199529', 'cui_str': 'Pulmonary rehabilitation'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0028125', 'cui_str': 'Nitrate salt'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C1095905', 'cui_str': 'Beets preparation'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0199529', 'cui_str': 'Pulmonary rehabilitation'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0002940', 'cui_str': 'Aneurysm'}, {'cui': 'C0424679', 'cui_str': 'Fat-free mass'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C4280053', 'cui_str': 'Incremental Shuttle Walk Test'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]",165.0,0.764259,"Exercise capacity increased more with active treatment (n=57) than placebo (n=65); median (IQR) change in ISWT distance +60 m (10, 85) vs +30 m (0, 70), estimated treatment effect 30 m (95% CI 10 to 40); p=0.027.","[{'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Pavitt', 'Affiliation': 'National Heart and Lung Institute, Royal Brompton Campus, Imperial College London, London, UK.'}, {'ForeName': 'Rebecca Jayne', 'Initials': 'RJ', 'LastName': 'Tanner', 'Affiliation': 'National Heart and Lung Institute, Royal Brompton Campus, Imperial College London, London, UK.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Lewis', 'Affiliation': 'National Heart and Lung Institute, Royal Brompton Campus, Imperial College London, London, UK.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Buttery', 'Affiliation': 'National Heart and Lung Institute, Royal Brompton Campus, Imperial College London, London, UK.'}, {'ForeName': 'Bhavin', 'Initials': 'B', 'LastName': 'Mehta', 'Affiliation': 'Respiratory Medicine, Royal Brompton and Harefield NHS Foundation Trust, London, UK.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Jefford', 'Affiliation': 'Greenwich Adult Community Health Service, Oxleas NHS Foundation Trust, Dartford, Kent, UK.'}, {'ForeName': 'Katrina J', 'Initials': 'KJ', 'LastName': 'Curtis', 'Affiliation': 'National Heart and Lung Institute, Royal Brompton Campus, Imperial College London, London, UK.'}, {'ForeName': 'Winston A S', 'Initials': 'WAS', 'LastName': 'Banya', 'Affiliation': 'National Heart and Lung Institute, Royal Brompton Campus, Imperial College London, London, UK.'}, {'ForeName': 'Syed', 'Initials': 'S', 'LastName': 'Husain', 'Affiliation': 'Respiratory Medicine, Maidstone and Tunbridge Wells NHS Trust, Maidstone, Kent, UK.'}, {'ForeName': 'Karnan', 'Initials': 'K', 'LastName': 'Satkunam', 'Affiliation': 'Greenwich Adult Community Health Service, Oxleas NHS Foundation Trust, Dartford, Kent, UK.'}, {'ForeName': 'Dinesh', 'Initials': 'D', 'LastName': 'Shrikrishna', 'Affiliation': 'Musgrove Park Hospital, Taunton and Somerset NHS Foundation Trust, Taunton, Somerset, UK.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Man', 'Affiliation': 'National Heart and Lung Institute, Royal Brompton Campus, Imperial College London, London, UK.'}, {'ForeName': 'Michael I', 'Initials': 'MI', 'LastName': 'Polkey', 'Affiliation': 'National Heart and Lung Institute, Royal Brompton Campus, Imperial College London, London, UK.'}, {'ForeName': 'Nicholas S', 'Initials': 'NS', 'LastName': 'Hopkinson', 'Affiliation': 'National Heart and Lung Institute, Royal Brompton Campus, Imperial College London, London, UK n.hopkinson@ic.ac.uk.'}]",Thorax,['10.1136/thoraxjnl-2019-214278'] 67,32376984,"Different exercise training modalities produce similar endothelial function improvements in individuals with prehypertension or hypertension: a randomized clinical trial Exercise, endothelium and blood pressure.","Endothelial dysfunction is a characteristic of systemic arterial hypertension (SAH) and an early marker of atherosclerosis. Aerobic exercise training (AT) improves endothelial function. However, the effects of resistance training (RT) and combined training (CT) on endothelial function remain controversial in individuals with SAH. We determined the effects of AT, RT, and CT on endothelial function and systolic (SBP)/diastolic blood pressure (DBP) in individuals with prehypertension or hypertension. Forty-two participants (54 ± 11 y, resting SBP/DBP 137 ± 9/86 ± 6 mmHg) were randomly allocated into AT (n = 14, 40 min of cycling, 50-75% heart rate reserve), RT (n = 14, 6 resistance exercises, 4 × 12 repetitions, 60% maximum strength) and CT (n = 14, 2 × 12 repetitions of RT + 20 min of AT). All participants performed a 40-minute exercise session twice a week for 8 weeks. Endothelial function was evaluated by brachial artery flow-mediated dilation (FMD). Blood pressure was evaluated through ambulatory monitoring for 24 hours. After 8 weeks of exercise training, blood pressure was reduced in all 3 groups: -5.1 mmHg in SBP (95%CI -10.1, 0.0; p = 0.003) in AT; -4.0 mmHg in SBP (95%CI -7.8, -0.5; p = 0.027) in RT; and -3.2 mmHg in DBP (95%CI -7.9, 1.5; p = 0.001) in CT. All 3 exercise training modalities produced similar improvements in FMD: + 3.2% (95%CI 1.7, 4.6) (p < 0.001) in AT; + 4.0% (95%CI 2.1, 5.7) (p < 0.001) in RT; and +6.8% (95%CI 2.6, 11.1) (p = 0.006) in CT. In conclusion, different exercise training modalities were similarly effective in improving endothelial function but impacts on ambulatory blood pressure appear to be variable in individuals with prehypertension or hypertension.",2020,"After 8 weeks of exercise training, blood pressure was reduced in all 3 groups: -5.1 mmHg in SBP (95%CI -10.1, 0.0; p = 0.003) in AT; -4.0 mmHg in SBP (95%CI -7.8, -0.5; p = 0.027) in RT; and -3.2 mmHg in DBP (95%CI -7.9, 1.5; p = 0.001) in CT.","['Forty-two participants (54\u2009±\u200911\u2009y, resting SBP/DBP 137\u2009±\u20099/86\u2009±\u20096\u2009mmHg', 'individuals with SAH', 'individuals with prehypertension or hypertension']","['AT, RT, and CT', '40-minute exercise session', 'exercise training modalities', 'Aerobic exercise training (AT', 'resistance training (RT) and combined training (CT']","['endothelial function', 'Endothelial function', 'blood pressure', 'endothelial function and systolic (SBP)/diastolic blood pressure (DBP', 'ambulatory blood pressure', 'brachial artery flow-mediated dilation (FMD', 'FMD', 'Blood pressure', 'endothelial function improvements']","[{'cui': 'C4319566', 'cui_str': '42'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0085805', 'cui_str': 'Androgen Binding Protein'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C4517569', 'cui_str': '137'}, {'cui': 'C0439475', 'cui_str': 'mmHg'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C1696708', 'cui_str': 'Prehypertension'}]","[{'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}]","[{'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0855316', 'cui_str': 'Blood pressure ambulatory'}, {'cui': 'C0006087', 'cui_str': 'Structure of brachial artery'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0012359', 'cui_str': 'Dilatation'}]",,0.0337369,"After 8 weeks of exercise training, blood pressure was reduced in all 3 groups: -5.1 mmHg in SBP (95%CI -10.1, 0.0; p = 0.003) in AT; -4.0 mmHg in SBP (95%CI -7.8, -0.5; p = 0.027) in RT; and -3.2 mmHg in DBP (95%CI -7.9, 1.5; p = 0.001) in CT.","[{'ForeName': 'Marinei L', 'Initials': 'ML', 'LastName': 'Pedralli', 'Affiliation': 'Institute of Cardiology of Rio Grande do Sul/University Foundation of Cardiology, Porto Alegre, Brazil.'}, {'ForeName': 'Rafael A', 'Initials': 'RA', 'LastName': 'Marschner', 'Affiliation': 'Thyroid Section, Endocrine Division, Hospital de Clínicas de Porto Alegre, Federal University of Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'Daniel P', 'Initials': 'DP', 'LastName': 'Kollet', 'Affiliation': 'Institute of Cardiology of Rio Grande do Sul/University Foundation of Cardiology, Porto Alegre, Brazil.'}, {'ForeName': 'Salvador G', 'Initials': 'SG', 'LastName': 'Neto', 'Affiliation': 'Institute of Cardiology of Rio Grande do Sul/University Foundation of Cardiology, Porto Alegre, Brazil.'}, {'ForeName': 'Bruna', 'Initials': 'B', 'LastName': 'Eibel', 'Affiliation': 'Institute of Cardiology of Rio Grande do Sul/University Foundation of Cardiology, Porto Alegre, Brazil.'}, {'ForeName': 'Hirofumi', 'Initials': 'H', 'LastName': 'Tanaka', 'Affiliation': 'Cardiovascular Aging Research Laboratory, Department of Kinesiology & Health Education, The University of Texas at Austin, Austin, TX, USA.'}, {'ForeName': 'Alexandre M', 'Initials': 'AM', 'LastName': 'Lehnen', 'Affiliation': 'Institute of Cardiology of Rio Grande do Sul/University Foundation of Cardiology, Porto Alegre, Brazil. amlehnen@gmail.com.'}]",Scientific reports,['10.1038/s41598-020-64365-x'] 68,32379483,A Sensory Stimulation Protocol to Modulate Cough Sensitivity: A Randomized Controlled Trial Safety Study.,"Purpose This study evaluated the safety and efficacy of a sensory stimulation protocol that was designed to modulate citric acid cough thresholds as a potential treatment for silent aspiration. Method Healthy adults ( n = 24) were randomly assigned to one of three sensory stimulation groups: (a) high-intensity ultrasonically nebulized distilled water (UNDW) inhalations (1.6 ml/min); (b) low-intensity UNDW inhalations (0.5 ml/min); and (3) control, 0.9% saline inhalations (1.6 ml/min). Sensory stimulation was delivered once a day, for 4 consecutive days. Citric acid cough thresholds were determined at baseline, Day 3, and Day 5 to evaluate changes in cough sensitivity. Spirometry was undertaken before, during, and after each sensory stimulation session to monitor for bronchoconstriction. Results No participant showed evidence of bronchoconstriction during the sensory stimulation protocol. There was an interaction effect between day and group on suppressed cough thresholds, χ 2 (4) = 11.32, p = .02. When compared to the control group, there was a decrease in citric acid cough thresholds across Days 1-5 in the high-intensity (-1.8 doubling concentrations, 95% confidence interval [-2.88, -0.72], p = .01) and low-intensity (-1.3 doubling concentrations, 95% confidence interval [-2.4, -0.2], p = .03) UNDW inhalation groups, representing a sensitization effect of UNDW inhalations on cough sensitivity. Conclusions The UNDW sensory stimulation protocol was safe in healthy adults. The findings provide preliminary evidence that UNDW inhalations sensitize laryngeal afferents related to citric acid-induced cough induction. The therapeutic potential of the UNDW sensory stimulation protocol will be explored in patients with reduced cough sensitivity who are at risk of silent aspiration and aspiration pneumonia. Plain Language Summary This study explored the safety and efficacy of a sensory stimulation protocol that was designed to modulate cough sensitivity as a potential treatment for silent aspiration. The study revealed that inhalations of nebulized distilled water were safe and increased cough sensitivity, when compared to control saline inhalations.",2020,"The study revealed that inhalations of nebulized distilled water were safe and increased cough sensitivity, when compared to control saline inhalations.","['Method Healthy adults ( n = 24', 'silent aspiration', 'healthy adults', 'patients with reduced cough sensitivity who are at risk of silent aspiration and aspiration pneumonia']","['Sensory Stimulation Protocol', 'sensory stimulation groups: (a) high-intensity ultrasonically nebulized distilled water (UNDW) inhalations (1.6 ml/min); (b) low-intensity UNDW inhalations', 'UNDW inhalations', 'sensory stimulation protocol']","['bronchoconstriction', 'Cough Sensitivity', 'cough sensitivity', 'safety and efficacy', 'Citric acid cough thresholds', 'safe and increased cough sensitivity', 'citric acid cough thresholds', 'low-intensity']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C4324315', 'cui_str': 'Silent aspiration'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0032290', 'cui_str': 'Aspiration pneumonia'}]","[{'cui': 'C0150763', 'cui_str': 'Sensory stimulation'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C4517508', 'cui_str': '1.6'}, {'cui': 'C0439445', 'cui_str': 'mL/min'}, {'cui': 'C0596836', 'cui_str': 'Light intensity'}]","[{'cui': 'C0079043', 'cui_str': 'Bronchial Constriction'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0055819', 'cui_str': 'Citric Acid'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0596836', 'cui_str': 'Light intensity'}]",24.0,0.0962598,"The study revealed that inhalations of nebulized distilled water were safe and increased cough sensitivity, when compared to control saline inhalations.","[{'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Wallace', 'Affiliation': 'Department of Communication Disorders, Rose Centre for Stroke Recovery and Research, University of Canterbury, Christchurch, New Zealand.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Guiu Hernandez', 'Affiliation': 'Department of Communication Disorders, Rose Centre for Stroke Recovery and Research, University of Canterbury, Christchurch, New Zealand.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Epton', 'Affiliation': 'Canterbury Respiratory Research Group, Christchurch Hospital, New Zealand.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Ploen', 'Affiliation': 'Respiratory Physiology Laboratory, Christchurch Hospital, New Zealand.'}, {'ForeName': 'Maggie-Lee', 'Initials': 'ML', 'LastName': 'Huckabee', 'Affiliation': 'Department of Communication Disorders, Rose Centre for Stroke Recovery and Research, University of Canterbury, Christchurch, New Zealand.'}, {'ForeName': 'Phoebe', 'Initials': 'P', 'LastName': 'Macrae', 'Affiliation': 'Department of Communication Disorders, Rose Centre for Stroke Recovery and Research, University of Canterbury, Christchurch, New Zealand.'}]",American journal of speech-language pathology,['10.1044/2020_AJSLP-19-00180'] 69,30778865,Estimating Quality of Life Decrements Due to Diabetes Complications in the United States: The Health Utility Index (HUI) Diabetes Complication Equation.,"OBJECTIVE Health utility decrements associated with diabetes mellitus complications are essential for calculating quality-adjusted life-years (QALYs) in patients for use in economic evaluation of diabetes interventions. Previous studies mostly focused on assessing the impact of complications on health utility at event year based on cross-sectional data. This study aimed to separately estimate health utility decrements associated with current and previous diabetes complications. RESEARCH DESIGN AND METHODS The Health Utilities Index Mark 3 (HUI-3) was used to measure heath utility in the Action to Control Cardiovascular Risk in Diabetes (ACCORD) trial (N = 8713). Five macrovascular complications (myocardial infarction [MI], congestive heart failure [CHF], stroke, angina, and revascularization surgery [RS]) and three microvascular complications (nephropathy [renal failure], retinopathy [severe vision loss], and neuropathy [severe pressure sensation loss]) were included in a set of alternative modelling approaches including the ordinary least squares (OLS) model, fixed effects model, and random effects model to estimate the complication-related health utility decrements. RESULTS All macrovascular complications were associated with decrements of HUI-3 scores: MI (event year: - 0.042, successive years: - 0.011), CHF (event year: - 0.089, successive years: - 0.041), stroke (event year: - 0.204, successive years: - 0.101), angina (event year: - 0.010, successive years: - 0.032), and revascularization (event year: - 0.038, successive years: - 0.016) (all p < 0.05). For microvascular complications, severe vision loss (- 0.057), and severe pressure sensation loss (- 0.066) were significantly associated with decrements of HUI-3 scores (both p < 0.05). Hypoglycemia (both severe and symptomatic) was found to be associated with a 0.036 decrement of health utility at event year, and a 0.033 decrement of health utility at successive years. Results from an OLS model are preferred for supporting a microsimulation model while a fixed effects model is preferred to describe direct health impacts from complications. CONCLUSIONS Macrovascular and microvascular complications caused QALY decrements in patients with type 2 diabetes. While only part of the total impaired QALY is experienced during the event year, further QALY decrements for successive years were quite substantial.",2019,"Hypoglycemia (both severe and symptomatic) was found to be associated with a 0.036 decrement of health utility at event year, and a 0.033 decrement of health utility at successive years.",['patients with type 2 diabetes'],[],"['Hypoglycemia', 'HUI-3 scores', 'severe pressure sensation loss', 'microvascular complications, severe vision loss', 'CHF', 'All macrovascular complications', 'health utility', 'ordinary least squares (OLS) model, fixed effects model, and random effects model to estimate the complication-related health utility decrements', 'Five macrovascular complications (myocardial infarction [MI], congestive heart failure [CHF], stroke, angina, and revascularization surgery [RS]) and three microvascular complications (nephropathy [renal failure], retinopathy [severe vision loss], and neuropathy [severe pressure sensation loss', 'HUI-3 scores: MI']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]",[],"[{'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0522501', 'cui_str': 'Massive'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0234222', 'cui_str': 'Baresthesia'}, {'cui': 'C0443258', 'cui_str': 'Microvascular'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C1301509', 'cui_str': 'Severe visual impairment'}, {'cui': 'C0018802', 'cui_str': 'Congestive heart failure'}, {'cui': 'C0023189', 'cui_str': 'Analysis, Least-Squares'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0002962', 'cui_str': 'Angina pectoris'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0022658', 'cui_str': 'Kidney disease'}, {'cui': 'C0035078', 'cui_str': 'Renal insufficiency'}, {'cui': 'C0035309', 'cui_str': 'Retinal disorder'}, {'cui': 'C0442874', 'cui_str': 'Neuropathy'}]",,0.0222959,"Hypoglycemia (both severe and symptomatic) was found to be associated with a 0.036 decrement of health utility at event year, and a 0.033 decrement of health utility at successive years.","[{'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Shao', 'Affiliation': 'Department of Health Policy and Management, School of Public Health and Tropical Medicine, Tulane University, 1440 Canal Street, Suite 1900, New Orleans, LA, 70112, USA.'}, {'ForeName': 'Shuang', 'Initials': 'S', 'LastName': 'Yang', 'Affiliation': 'Department of Health Policy and Management, School of Public Health and Tropical Medicine, Tulane University, 1440 Canal Street, Suite 1900, New Orleans, LA, 70112, USA.'}, {'ForeName': 'Vivian', 'Initials': 'V', 'LastName': 'Fonseca', 'Affiliation': 'School of Medicine, Tulane University, New Orleans, LA, USA.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Stoecker', 'Affiliation': 'Department of Health Policy and Management, School of Public Health and Tropical Medicine, Tulane University, 1440 Canal Street, Suite 1900, New Orleans, LA, 70112, USA.'}, {'ForeName': 'Lizheng', 'Initials': 'L', 'LastName': 'Shi', 'Affiliation': 'Department of Health Policy and Management, School of Public Health and Tropical Medicine, Tulane University, 1440 Canal Street, Suite 1900, New Orleans, LA, 70112, USA. lshi1@tulane.edu.'}]",PharmacoEconomics,['10.1007/s40273-019-00775-8'] 70,32380852,Enhanced rehabilitation guidance after arthroscopic capsulolabral repair of the shoulder: a randomized controlled trial.,"OBJECTIVE To compare the effects of a 12-month home-based exercise program to usual care in patients after arthroscopic capsulolabral repair of the shoulder. DESIGN Randomized controlled trial. SETTING Outpatient physical and rehabilitation medicine clinic. SUBJECTS Forty-five patients (mean age: 35 years; standard deviation (SD): 10 years) who underwent arthroscopic capsulolabral repair due to labral lesion were randomized into an exercise group (EG) or a control group (CG). INTERVENTION The EG received a 12-month home-based additional exercise program with four physiotherapy follow-up visits, while the CG received standard postoperative exercise instructions. MAIN MEASURES Self-reported shoulder disability was assessed with the American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES) and quality of life with the Short-Form (SF)-36 Health Survey. The function of the operated shoulder was evaluated with strength and range of motion measurements. RESULTS No between-group differences were observed in any of the outcomes at the follow-up. Mean ASES score improved by 16 (95% confidence interval (CI): 10-23) points from the baseline 78 (SD: 17) in the EG and 13 (95% CI: 7-19) points from the baseline 79 (SD: 17) in the CG. Both groups achieved a significant improvement in the dimensions of Physical Functioning, Role-Physical, and Bodily Pain of the SF-36 and in every aspect of strength and range of motion measures. In EG, exercise adherence was moderate (52%) during the first six months and poor (22%) during the last six months. CONCLUSION Home-based additional exercises with four outpatient follow-up visits did not improve outcome after arthroscopic capsular repair of the shoulder.",2020,"Both groups achieved a significant improvement in the dimensions of Physical Functioning, Role-Physical, and Bodily Pain of the SF-36 and in every aspect of strength and range of motion measures.","['arthroscopic capsulolabral repair of the shoulder', 'Outpatient physical and rehabilitation medicine clinic', 'patients after arthroscopic capsulolabral repair of the shoulder', 'Forty-five patients (mean age: 35\u2009years; standard deviation (SD): 10\u2009years) who underwent arthroscopic capsulolabral repair due to labral lesion']","['home-based exercise program', 'home-based additional exercise program with four physiotherapy follow-up visits, while the CG received standard postoperative exercise instructions', 'exercise group (EG) or a control group (CG']","['Self-reported shoulder disability', 'exercise adherence', 'American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES) and quality of life with the Short-Form (SF)-36 Health Survey', 'Mean ASES score', 'dimensions of Physical Functioning, Role-Physical, and Bodily Pain of the SF-36 and in every aspect of strength and range of motion measures']","[{'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0031813', 'cui_str': 'Physical Medicine and Rehabilitation'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C0589121', 'cui_str': 'Follow-up visit'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C1276393', 'cui_str': 'Group exercise'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0013769', 'cui_str': 'Elbow region structure'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",,0.0607013,"Both groups achieved a significant improvement in the dimensions of Physical Functioning, Role-Physical, and Bodily Pain of the SF-36 and in every aspect of strength and range of motion measures.","[{'ForeName': 'Juhani', 'Initials': 'J', 'LastName': 'Multanen', 'Affiliation': 'Faculty of Sport and Health Sciences, University of Jyväskylä, Jyväskylä, Finland.'}, {'ForeName': 'Pauli', 'Initials': 'P', 'LastName': 'Kiuru', 'Affiliation': 'Faculty of Sport and Health Sciences, University of Jyväskylä, Jyväskylä, Finland.'}, {'ForeName': 'Kirsi', 'Initials': 'K', 'LastName': 'Piitulainen', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Central Finland Hospital District, Jyväskylä, Finland.'}, {'ForeName': 'Jari', 'Initials': 'J', 'LastName': 'Ylinen', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Central Finland Hospital District, Jyväskylä, Finland.'}, {'ForeName': 'Juha', 'Initials': 'J', 'LastName': 'Paloneva', 'Affiliation': 'Department of Surgery, Central Finland Hospital District, Jyväskylä, Finland.'}, {'ForeName': 'Arja', 'Initials': 'A', 'LastName': 'Häkkinen', 'Affiliation': 'Faculty of Sport and Health Sciences, University of Jyväskylä, Jyväskylä, Finland.'}]",Clinical rehabilitation,['10.1177/0269215520919472'] 71,32386065,Stereoselective Steady-State Disposition and Bioequivalence of Brand and Generic Bupropion in Adults.,"The antidepressant bupropion is stereoselectively metabolized and metabolite enantiomers have differential pharmacologic effects, but steady-state enantiomeric disposition is unknown. Controversy persists about bupropion XL 300 mg generic equivalence to brand product, and whether generics might have different stereoselective disposition leading to enantiomeric non-bioequivalence and, thus, clinical nonequivalence. This preplanned follow-on analysis of a prospective, randomized, double-blinded, crossover study of brand and 3 generic bupropion XL 300 mg products measured steady-state enantiomeric plasma and urine parent bupropion and primary and secondary metabolite concentrations and evaluated bioequivalence and pharmacokinetics. Steady-state plasma and urine bupropion disposition was markedly stereoselective, with up to 40-fold differences in plasma concentrations of the active metabolite S,S-hydroxybupropion vs. R,R,-hydroxybupropion. Urine metabolite glucuronides were prominent, but glucuronidation was metabolite-specific and enantioselective. There were no differences between any generic and brand, or between generics, in plasma enantiomer concentrations of bupropion or the major metabolites. All generic products satisfied formal bioequivalence criteria (peak plasma concentration (C max ) and area under the plasma concentration-time curve over 24 hours (AUC 0-24 )) using enantiomers for bupropion as well as for metabolites, and generics were comparable to each other, and were considered bioequivalent, based on enantiomeric analysis. Enantiomeric bioequivalence explains the previously observed therapeutic equivalence of bupropion generics and brand in treating major depression. These results have important implications for understanding the clinical therapeutic effects of bupropion based on complex and stereoselective metabolism.",2020,"All generic products satisfied formal bioequivalence criteria (C max and AUC 0-24 ) using enantiomers for bupropion as well as for metabolites, and generics were comparable to each other, and were considered bioequivalent, based on enantiomeric analysis.",['adults'],"['bupropion', 'brand and three generic bupropion XL300']","['steady-state enantiomeric plasma and urine parent bupropion and primary and secondary metabolite concentrations and evaluated bioequivalence and pharmacokinetics', 'Steady-state plasma and urine bupropion disposition', 'Urine metabolite glucuronides']","[{'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0085208', 'cui_str': 'Bupropion'}, {'cui': 'C0085155', 'cui_str': 'Generic Drugs'}]","[{'cui': 'C0205361', 'cui_str': 'Steady'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0085208', 'cui_str': 'Bupropion'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0039789', 'cui_str': 'Equivalencies, Therapeutic'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0184758', 'cui_str': 'Patient disposition'}, {'cui': 'C0752086', 'cui_str': 'Glucuronides'}]",,0.0306987,"All generic products satisfied formal bioequivalence criteria (C max and AUC 0-24 ) using enantiomers for bupropion as well as for metabolites, and generics were comparable to each other, and were considered bioequivalent, based on enantiomeric analysis.","[{'ForeName': 'Evan D', 'Initials': 'ED', 'LastName': 'Kharasch', 'Affiliation': 'Department of Anesthesiology, Duke University School of Medicine, Durham, North Carolina, USA.'}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Neiner', 'Affiliation': 'Department of Anesthesiology, Washington University in St. Louis, St. Louis, Missouri, USA.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Kraus', 'Affiliation': 'Department of Anesthesiology, Washington University in St. Louis, St. Louis, Missouri, USA.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Blood', 'Affiliation': 'Department of Anesthesiology, Washington University in St. Louis, St. Louis, Missouri, USA.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Stevens', 'Affiliation': 'Department of Psychiatry, Washington University in St. Louis, St. Louis, Missouri, USA.'}, {'ForeName': 'J Philip', 'Initials': 'JP', 'LastName': 'Miller', 'Affiliation': 'Division of Biostatistics, Washington University in St. Louis, St. Louis, Missouri, USA.'}, {'ForeName': 'Eric J', 'Initials': 'EJ', 'LastName': 'Lenze', 'Affiliation': 'Department of Psychiatry, Washington University in St. Louis, St. Louis, Missouri, USA.'}]",Clinical pharmacology and therapeutics,['10.1002/cpt.1888'] 72,32384056,Young People's Experience of a Long-Term Social Media-Based Intervention for First-Episode Psychosis: Qualitative Analysis.,"BACKGROUND Digital mental health interventions present a unique opportunity to address the lack of social connection and loneliness experienced by young people with first-episode psychosis (FEP). The first generation of digital interventions, however, is associated with high attrition rates. Social media presents an opportunity to target this issue. A new generation of digital intervention has harnessed the popularity of social media to both promote engagement and foster social connectedness in youth mental health interventions. Despite their potential, little is known about how young people engage with, and experience, social media-based interventions as well as the optimal design, implementation, and management needed to ensure young people with psychosis receive benefit. OBJECTIVE This study aimed to explore how young people engage with, and experience, a long-term social media-based mental health intervention designed to address social functioning in individuals with FEP. METHODS This qualitative study was based on 12 interviews with young people who used Horyzons, a long-term social media-based mental health intervention, as part of a previous randomized controlled trial. A semistructured phenomenological interview guide with open-ended questions was used to explore young people's subjective experience of the intervention. All interviews were recorded and transcribed verbatim. Data were analyzed using interpretative phenomenological analysis. RESULTS A total of 4 superordinate themes emerged during the analysis including (1) shared experience as the catalyst for a cocreated social space, (2) the power of peer support, (3) an upbeat environment, and (4) experiences that interrupt being in Horyzons. CONCLUSIONS We found that Horyzon's therapeutic social network fostered a connection and an understanding among young people. It also aided in the creation of an embodied experience that afforded young people with FEP a sense of self-recognition and belonging over the long term. However, although we found that most young people had strong positive experiences of a social connection on Horyzons, we also found that they experienced significant barriers that could substantively interrupt their ability to use the platform. We found that social anxiety, paranoia, internalized stigma, lack of autonomy, and social protocol confusion interfered with young people's usage of the platform. From a design perspective, digital interventions are flexible and thus equipped to begin addressing these implications by providing customizable and personalized treatment options that account for varying levels of social connection and psychological need that could otherwise interrupt young people's usage of social media-based interventions.",2020,It also aided in the creation of an embodied experience that afforded young people with FEP a sense of self-recognition and belonging over the long term.,"['young people', 'young people engage with, and experience, a long-term social media-based mental health intervention designed to address social functioning in individuals with', 'young people with first-episode psychosis (FEP', '12 interviews with young people who used Horyzons, a long-term social media-based mental health intervention, as part of a previous randomized controlled trial']",['digital intervention'],"['social anxiety, paranoia, internalized stigma, lack of autonomy, and social protocol confusion']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C3179065', 'cui_str': 'Social Medium'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0376649', 'cui_str': 'Addresses'}, {'cui': 'C0037395', 'cui_str': 'Social adjustment'}, {'cui': 'C0439615', 'cui_str': 'First episode'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0424166', 'cui_str': 'Social fear'}, {'cui': 'C1456784', 'cui_str': 'Paranoid disorder'}, {'cui': 'C0277787', 'cui_str': 'Stigma'}, {'cui': 'C0332268', 'cui_str': 'Lacking'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0009676', 'cui_str': 'Confusional state'}]",12.0,0.0185373,It also aided in the creation of an embodied experience that afforded young people with FEP a sense of self-recognition and belonging over the long term.,"[{'ForeName': 'Lee', 'Initials': 'L', 'LastName': 'Valentine', 'Affiliation': 'Orygen, Parkville, Australia.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'McEnery', 'Affiliation': 'Orygen, Parkville, Australia.'}, {'ForeName': 'Shaunagh', 'Initials': 'S', 'LastName': ""O'Sullivan"", 'Affiliation': 'Orygen, Parkville, Australia.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Gleeson', 'Affiliation': 'School of Behavioural and Health Sciences, Australian Catholic University, Melbourne, Australia.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Bendall', 'Affiliation': 'Orygen, Parkville, Australia.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Alvarez-Jimenez', 'Affiliation': 'Orygen, Parkville, Australia.'}]",Journal of medical Internet research,['10.2196/17570'] 73,32386127,Early child development in children who are HIV-exposed uninfected compared to children who are HIV-unexposed: observational sub-study of a cluster-randomized trial in rural Zimbabwe.,"INTRODUCTION Exposure to maternal HIV may affect early child development (ECD), although previous studies have reported heterogeneous findings. We evaluated ECD among children who were HIV-exposed uninfected (CHEU) and children who were HIV-unexposed (CHU) recruited to the SHINE trial in rural Zimbabwe. METHODS SHINE was a community-based cluster-randomized trial of improved infant feeding and/or improved water, sanitation and hygiene. Pregnant women were enrolled between 2012 and 2015. We assessed ECD in a sub-study at 24 months of age, between 2016 and 2017, using the Malawi Developmental Assessment Tool (MDAT; assessing motor, cognitive, language and social development); MacArthur-Bates Communicative Development Inventory (CDI) (assessing vocabulary and grammar); A-not-B test (assessing object permanence); and a self-control task. Mothers and infants were tested longitudinally for HIV. We used generalized estimating equations to compare ECD scores between CHEU and CHU, accounting for the cluster-randomized design. Primary results were adjusted for trial-related factors that could affect measurement reliability of ECD: study nurse, age of child, calendar month of birth, sex and randomized arm. RESULTS A total of 205 CHEU and 1175 CHU were evaluated. Mean total MDAT score was 90.6 (SD 8.7) in CHEU compared to 92.4 (9.1) in CHU (adjusted mean difference -1.3, 95% CI: -2.3, -0.3), driven mostly by differences in gross motor (-0.5, 95% CI: -0.9, -0.2) and language scores (-0.6, 95% CI: -1.1, -0.1). There was evidence that fine motor scores were lower in CHEU (adjusted mean difference -0.4, 95% CI: -0.8, 0.0) but no evidence of a difference in social scores (0.1, 95% CI: -0.2, 0.4). Mean MacArthur-Bates CDI vocabulary score was 57.9 (SD 19.2) in CHEU compared to 61.3 (18.8) in CHU (adjusted mean difference -2.9 words, 95% CI: -5.7, -0.1). Object permanence and self-control scores were similar between groups. CONCLUSIONS CHEU in rural Zimbabwe had total child development and vocabulary scores that were approximately 0.15 standard deviations lower than CHU at two years of age. More detailed and specific studies are now needed to unravel the reasons for developmental delay in CHEU and the likelihood that these delays persist in the longer term.",2020,"There was evidence that fine motor scores were lower in CHEU (adjusted mean difference -0.4, 95% CI: -0.8, 0.0) but no evidence of a difference in social scores (0.1, 95% CI: -0.2, 0.4).","['SHINE was a community-based cluster-randomized trial of improved infant feeding and/or improved water, sanitation and hygiene', 'children who are HIV-exposed uninfected compared to children who are HIV-unexposed: observational sub-study of a cluster-randomized trial in rural Zimbabwe', 'children who were HIV-exposed uninfected (CHEU) and children who were HIV-unexposed (CHU) recruited to the SHINE trial in rural Zimbabwe', 'Pregnant women were enrolled between 2012 and 2015']",[],"['language scores', 'total child development and vocabulary scores', 'Malawi Developmental Assessment Tool (MDAT; assessing motor, cognitive, language and social development); MacArthur-Bates Communicative Development Inventory (CDI) (assessing vocabulary and grammar); A-not-B test (assessing object permanence', 'Mean MacArthur-Bates CDI vocabulary score', 'fine motor scores', 'Object permanence and self-control scores', 'Mean total MDAT score', 'social scores']","[{'cui': 'C1278569', 'cui_str': 'WAS A'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0036172', 'cui_str': 'Sanitation'}, {'cui': 'C0020405', 'cui_str': 'Hygiene'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C1518527', 'cui_str': 'Observational Study'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0043476', 'cui_str': 'Zimbabwe'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}]",[],"[{'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0008071', 'cui_str': 'Child Development'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0024548', 'cui_str': 'Malawi'}, {'cui': 'C0458003', 'cui_str': 'Developmental'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0037409', 'cui_str': 'Social Development'}, {'cui': 'C0006298', 'cui_str': 'Brown fat'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0589514', 'cui_str': 'Object constancy'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205232', 'cui_str': 'Fine'}, {'cui': 'C0684274', 'cui_str': 'Self-control'}]",,0.212219,"There was evidence that fine motor scores were lower in CHEU (adjusted mean difference -0.4, 95% CI: -0.8, 0.0) but no evidence of a difference in social scores (0.1, 95% CI: -0.2, 0.4).","[{'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Ntozini', 'Affiliation': 'Zvitambo Institute for Maternal and Child Health Research, Harare, Zimbabwe.'}, {'ForeName': 'Jaya', 'Initials': 'J', 'LastName': 'Chandna', 'Affiliation': 'Zvitambo Institute for Maternal and Child Health Research, Harare, Zimbabwe.'}, {'ForeName': 'Ceri', 'Initials': 'C', 'LastName': 'Evans', 'Affiliation': 'Zvitambo Institute for Maternal and Child Health Research, Harare, Zimbabwe.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Chasekwa', 'Affiliation': 'Zvitambo Institute for Maternal and Child Health Research, Harare, Zimbabwe.'}, {'ForeName': 'Florence D', 'Initials': 'FD', 'LastName': 'Majo', 'Affiliation': 'Zvitambo Institute for Maternal and Child Health Research, Harare, Zimbabwe.'}, {'ForeName': 'Gwendoline', 'Initials': 'G', 'LastName': 'Kandawasvika', 'Affiliation': 'University of Zimbabwe, Harare, Zimbabwe.'}, {'ForeName': 'Naume V', 'Initials': 'NV', 'LastName': 'Tavengwa', 'Affiliation': 'Zvitambo Institute for Maternal and Child Health Research, Harare, Zimbabwe.'}, {'ForeName': 'Batsirai', 'Initials': 'B', 'LastName': 'Mutasa', 'Affiliation': 'Zvitambo Institute for Maternal and Child Health Research, Harare, Zimbabwe.'}, {'ForeName': 'Kuda', 'Initials': 'K', 'LastName': 'Mutasa', 'Affiliation': 'Zvitambo Institute for Maternal and Child Health Research, Harare, Zimbabwe.'}, {'ForeName': 'Lawrence H', 'Initials': 'LH', 'LastName': 'Moulton', 'Affiliation': 'Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Jean H', 'Initials': 'JH', 'LastName': 'Humphrey', 'Affiliation': 'Zvitambo Institute for Maternal and Child Health Research, Harare, Zimbabwe.'}, {'ForeName': 'Melissa J', 'Initials': 'MJ', 'LastName': 'Gladstone', 'Affiliation': 'University of Liverpool, Liverpool, United Kingdom.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Prendergast', 'Affiliation': 'Zvitambo Institute for Maternal and Child Health Research, Harare, Zimbabwe.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of the International AIDS Society,['10.1002/jia2.25456'] 74,32388538,Serotonin differentially modulates the temporal dynamics of the limbic response to facial emotions in male adults with and without autism spectrum disorder (ASD): a randomised placebo-controlled single-dose crossover trial.,"Emotion processing-including signals from facial expressions-is often altered in individuals with autism spectrum disorder (ASD). The biological basis of this is poorly understood but may include neurochemically mediated differences in the responsivity of key 'limbic' regions (including amygdala, ventromedial prefrontal cortex (vmPFC) and nucleus accumbens (NAc)). Emerging evidence also suggests that ASD may be a disorder of brain temporal dynamics. Moreover, serotonin (5-HT) has been shown to be a key regulator of both facial-emotion processing and brain dynamics, and 5-HT abnormalities have been consistently implicated in ASD. To date, however, no one has examined how 5-HT influences the dynamics of facial-emotion processing in ASD. Therefore, we compared the influence of 5-HT on the responsivity of brain dynamics during facial-emotion processing in individuals with and without ASD. Participants completed a facial-emotion processing fMRI task at least 8 days apart using a randomised double-blind crossover design. At each visit they received either a single 20-mg oral dose of the selective serotonin reuptake inhibitor (SSRI) citalopram or placebo. We found that citalopram (which increases levels of 5-HT) caused sustained activation in key limbic regions during processing of negative facial emotions in adults with ASD-but not in neurotypical adults. The neurotypical adults' limbic response reverted more rapidly to baseline following a 5-HT-challenge. Our results suggest that serotonergic homoeostatic control of the temporal dynamics in limbic regions is altered in adults with ASD, and provide a fresh perspective on the biology of ASD.",2020,We found that citalopram (which increases levels of 5-HT) caused sustained activation in key limbic regions during processing of negative facial emotions in adults with ASD-but not in neurotypical adults.,"['individuals with autism spectrum disorder (ASD', 'individuals with and without ASD', 'male adults with and without autism spectrum disorder (ASD', 'adults with ASD']","['serotonin (5-HT', 'citalopram', 'Serotonin', 'selective serotonin reuptake inhibitor (SSRI) citalopram or placebo', 'Emotion processing-including signals from facial expressions', '5-HT', 'placebo']",['facial-emotion processing fMRI task'],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0036751', 'cui_str': 'Serotonin'}, {'cui': 'C0008845', 'cui_str': 'Citalopram'}, {'cui': 'C0360105', 'cui_str': 'Selective serotonin re-uptake inhibitor'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}]","[{'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}]",,0.311869,We found that citalopram (which increases levels of 5-HT) caused sustained activation in key limbic regions during processing of negative facial emotions in adults with ASD-but not in neurotypical adults.,"[{'ForeName': 'Nichol M L', 'Initials': 'NML', 'LastName': 'Wong', 'Affiliation': ""Department of Forensic and Neurodevelopmental Sciences, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK. nichol.wong@kcl.ac.uk.""}, {'ForeName': 'James L', 'Initials': 'JL', 'LastName': 'Findon', 'Affiliation': ""Department of Forensic and Neurodevelopmental Sciences, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Robert H', 'Initials': 'RH', 'LastName': 'Wichers', 'Affiliation': ""Department of Forensic and Neurodevelopmental Sciences, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Giampietro', 'Affiliation': ""Department of Neuroimaging, Institute of Psychiatry, Psychology, and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Vladimira', 'Initials': 'V', 'LastName': 'Stoencheva', 'Affiliation': ""Department of Forensic and Neurodevelopmental Sciences, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Clodagh M', 'Initials': 'CM', 'LastName': 'Murphy', 'Affiliation': ""Department of Forensic and Neurodevelopmental Sciences, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Blainey', 'Affiliation': ""Department of Forensic and Neurodevelopmental Sciences, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Ecker', 'Affiliation': 'Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, Goethe University Frankfurt am Main, Frankfurt, Germany.'}, {'ForeName': 'Declan G', 'Initials': 'DG', 'LastName': 'Murphy', 'Affiliation': ""Department of Forensic and Neurodevelopmental Sciences, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Grainne M', 'Initials': 'GM', 'LastName': 'McAlonan', 'Affiliation': ""Department of Forensic and Neurodevelopmental Sciences, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Eileen', 'Initials': 'E', 'LastName': 'Daly', 'Affiliation': ""Department of Forensic and Neurodevelopmental Sciences, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-020-0693-0'] 75,32387014,[Repurposing of chlorpromazine in COVID-19 treatment: the reCoVery study].,"OBJECTIVES The ongoing COVID-19 pandemic comprises a total of more than 2,350,000 cases and 160,000 deaths. The interest in anti-coronavirus drug development has been limited so far and effective methods to prevent or treat coronavirus infections in humans are still lacking. Urgent action is needed to fight this fatal coronavirus infection by reducing the number of infected people along with the infection contagiousness and severity. Since the beginning of the COVID-19 outbreak several weeks ago, we observe in GHU PARIS Psychiatrie & Neurosciences (Sainte-Anne hospital, Paris, France) a lower prevalence of symptomatic and severe forms of COVID-19 infections in psychiatric patients (∼4%) compared to health care professionals (∼14%). Similar observations have been noted in other psychiatric units in France and abroad. Our hypothesis is that psychiatric patients could be protected from severe forms of COVID-19 by their psychotropic treatments. Chlorpromazine (CPZ) is a phenothiazine derivative widely used in clinical routine in the treatment of acute and chronic psychoses. This first antipsychotic medication has been discovered in 1952 by Jean Delay and Pierre Deniker at Sainte-Anne hospital. In addition, to its antipsychotic effects, several in vitro studies have also demonstrated a CPZ antiviral activity via the inhibition of clathrin-mediated endocytosis. Recently, independent studies revealed that CPZ is an anti-MERS-CoV and an anti-SARS-CoV-1 drug. In comparison to other antiviral drugs, the main advantages of CPZ lie in its biodistribution: (i) preclinical and clinical studies have reported a high CPZ concentration in the lungs (20-200 times higher than in plasma), which is critical because of the respiratory tropism of SARS-CoV-2; (ii) CPZ is highly concentrated in saliva (30-100 times higher than in plasma) and could therefore reduce the contagiousness of COVID-19; (iii) CPZ can cross the blood-brain barrier and could therefore prevent the neurological forms of COVID-19. METHODS Our hypothesis is that CPZ could decrease the unfavorable evolution of COVID-19 infection in oxygen-requiring patients without the need for intensive care, but also reduce the contagiousness of SARS-CoV-2. At this end, we designed a pilot, phase III, multicenter, single blind, randomized controlled clinical trial. Efficacy of CPZ will be assessed according to clinical, biological and radiological criteria. The main objective is to demonstrate a shorter time to response (TTR) to treatment in the CPZ+standard-of-care (CPZ+SOC) group, compared to the SOC group. Response to treatment is defined by a reduction of at least one level of severity on the WHO-Ordinal Scale for Clinical Improvement (WHO-OSCI). The secondary objectives are to demonstrate in the CPZ+SOC group, compared to the SOC group: (A) superior clinical improvement; (B) a greater decrease in the biological markers of viral attack by SARS-CoV-2 (PCR, viral load); (C) a greater decrease in inflammatory markers (e.g. CRP and lymphopenia); (D) a greater decrease in parenchymal involvement (chest CT) on the seventh day post-randomization; (E) to define the optimal dosage of CPZ and its tolerance; (F) to evaluate the biological parameters of response to treatment, in particular the involvement of inflammatory cytokines. Patient recruitment along with the main and secondary objectives are in line with WHO 2020 COVID-19 guidelines. CONCLUSION This repositioning of CPZ as an anti-SARS-CoV-2 drug offers an alternative and rapid strategy to alleviate the virus propagation and the infection severity and lethality. This CPZ repositioning strategy also avoids numerous developmental and experimental steps and can save precious time to rapidly establish an anti-COVID-19 therapy with well-known, limited and easy to manage side effects. Indeed, CPZ is an FDA-approved drug with an excellent tolerance profile, prescribed for around 70 years in psychiatry but also in clinical routine in nausea and vomiting of pregnancy, in advanced cancer and also to treat headaches in various neurological conditions. The broad spectrum of CPZ treatment - including antipsychotic, anxiolytic, antiemetic, antiviral, immunomodulatory effects along with inhibition of clathrin-mediated endocytosis and modulation of blood-brain barrier - is in line with the historical French commercial name for CPZ, i.e. LARGACTIL, chosen as a reference to its ""LARGe ACTion"" properties. The discovery of those CPZ properties, as for many other molecules in psychiatry, is both the result of serendipity and careful clinical observations. Using this approach, the field of mental illness could provide innovative therapeutic approaches to fight SARS-CoV-2.",2020,The interest in anti-coronavirus drug development has been limited so far and effective methods to prevent or treat coronavirus infections in humans are still lacking.,['psychiatric patients'],"['Chlorpromazine (CPZ', 'CPZ', 'chlorpromazine', 'phenothiazine derivative']","['biological markers of viral attack by SARS-CoV-2 (PCR, viral load); (C) a greater decrease in inflammatory markers (e.g. CRP and lymphopenia', 'parenchymal involvement (chest CT', 'shorter time to response (TTR']","[{'cui': 'C0748064', 'cui_str': 'Psychiatric in-patient'}]","[{'cui': 'C0008286', 'cui_str': 'Chlorpromazine'}, {'cui': 'C0304370', 'cui_str': 'Phenothiazine derivative'}]","[{'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0004063', 'cui_str': 'Assault'}, {'cui': 'C0032520', 'cui_str': 'Polymerase chain reaction'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0024312', 'cui_str': 'Lymphocytopenia'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0202823', 'cui_str': 'CT of chest'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",,0.0622901,The interest in anti-coronavirus drug development has been limited so far and effective methods to prevent or treat coronavirus infections in humans are still lacking.,"[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Plaze', 'Affiliation': 'GHU Paris psychiatrie et neurosciences, site Sainte-Anne, service hospitalo-universitaire, pôle hospitalo-universitaire Paris 15, Paris, France; Université de Paris, Paris, France. Electronic address: m.plaze@ghu-paris.fr.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Attali', 'Affiliation': 'GHU Paris psychiatrie et neurosciences, site Sainte-Anne, service hospitalo-universitaire, pôle hospitalo-universitaire Paris 15, Paris, France; Université de Paris, Paris, France; Physics for medicine Paris, Inserm, ESPCI Paris, CNRS, PSL Research university, université Paris Diderot, Sorbonne Paris Cite, Paris, France.'}, {'ForeName': 'A-C', 'Initials': 'AC', 'LastName': 'Petit', 'Affiliation': 'GHU Paris psychiatrie et neurosciences, site Sainte-Anne, service hospitalo-universitaire, pôle hospitalo-universitaire Paris 15, Paris, France; Institut Pasteur, experimental neuropathology unit, Paris, France.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Blatzer', 'Affiliation': 'Institut Pasteur, experimental neuropathology unit, Paris, France.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Simon-Loriere', 'Affiliation': 'Institut Pasteur, G5 evolutionary genomics of RNA viruses, Paris, France.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Vinckier', 'Affiliation': 'GHU Paris psychiatrie et neurosciences, site Sainte-Anne, service hospitalo-universitaire, pôle hospitalo-universitaire Paris 15, Paris, France; Université de Paris, Paris, France.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Cachia', 'Affiliation': ""Université de Paris, Institut de Psychiatrie et Neurosciences de Paris, INSERM, Paris, France; Université de Paris, Laboratoire de Psychologie du développement et de l'Éducation de l'Enfant, CNRS, Paris, France.""}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Chrétien', 'Affiliation': 'Institut Pasteur, experimental neuropathology unit, Paris, France; GHU PARIS Psychiatrie et Neurosciences, site Sainte-Anne, service de Neuropathologie, Paris, France.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Gaillard', 'Affiliation': 'GHU Paris psychiatrie et neurosciences, site Sainte-Anne, service hospitalo-universitaire, pôle hospitalo-universitaire Paris 15, Paris, France; Université de Paris, Paris, France; Institut Pasteur, experimental neuropathology unit, Paris, France.'}]",L'Encephale,['10.1016/j.encep.2020.04.010'] 76,32387091,The clinical utility of apoB versus LDL-C/non-HDL-C.,"BACKGROUND The ESC/EAS Guidelines and the EAS/EFLM consensus reports state that apoB is a more accurate marker of cardiovascular risk than LDL-C or non-HDL-C and that apoB can be measured accurately and precisely than LDL-C or non-HDL-C. Nevertheless, EAS/EFLM called for a randomized clinical trial and a cost-effective analysis before widespread implementation of apoB. OBJECTIVE To analyse these issues from the perspective of clinical utility as clinical utility would be considered by an informed patient and physician. METHODS AND RESULTS We highlight the biological inaccuracies as well as the laboratory inaccuracies of LDL-C/non-HDL-C versus apoB. We demonstrate why the biological variance in the cholesterol loading per apoB particle makes it impossible to design a randomized clinical trial to compare apoB to LDL-C/non-HDL-C. We further demonstrate that even in the context of the United States, adding apoB to a lipid panel would have only a trivial effect on costs. CONCLUSION We submit that no informed patient or physician would choose a less accurate test over a more accurate test if the more accurate test added only trivially to the total cost of care. For these reasons, the clinical utility of apoB far exceeds the clinical utility of LDL-C/non-HDL-C.",2020,"For these reasons, the clinical utility of apoB far exceeds the clinical utility of LDL-C/non-HDL-C.",[],['apoB versus LDL-C/non-HDL-C'],[],[],"[{'cui': 'C0003593', 'cui_str': 'Apolipoprotein B'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}]",[],,0.0221709,"For these reasons, the clinical utility of apoB far exceeds the clinical utility of LDL-C/non-HDL-C.","[{'ForeName': 'Ciaran N', 'Initials': 'CN', 'LastName': 'Kohli-Lynch', 'Affiliation': 'Division of General Medicine, Columbia University Medical Center, New York, NY, USA; Health Economics and Health Technology Assessment, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Thanassoulis', 'Affiliation': 'Mike and Valeria Rosenbloom Centre for Cardiovascular Prevention, Division of Cardiology, Royal Victoria Hospital - McGill University Health Centre, 1001 Decarie Boulevard, Montreal, Quebec, Canada.'}, {'ForeName': 'Andrew E', 'Initials': 'AE', 'LastName': 'Moran', 'Affiliation': 'Division of General Medicine, Columbia University Medical Center, New York, NY, USA.'}, {'ForeName': 'Allan D', 'Initials': 'AD', 'LastName': 'Sniderman', 'Affiliation': 'Mike and Valeria Rosenbloom Centre for Cardiovascular Prevention, Division of Cardiology, Royal Victoria Hospital - McGill University Health Centre, 1001 Decarie Boulevard, Montreal, Quebec, Canada. Electronic address: allansniderman@hotmail.com.'}]",Clinica chimica acta; international journal of clinical chemistry,['10.1016/j.cca.2020.05.001'] 77,32387140,Religious Coping in Cancer: A Quantitative Analysis of Expressive Writing Samples From Patients With Renal Cell Carcinoma.,"CONTEXT Past religiosity/spirituality (R/S) research has mainly relied on self-report instruments, which may result in self-presentation and defensive biases. OBJECTIVES To address these limitations, we reviewed the writing samples that were generated as part of an expressive writing (EW) trial, coded the samples for R/S content, and examined cross-sectional and prospective associations between R/S content and symptom and psychosocial outcomes. METHODS Participants diagnosed with renal cell carcinoma who were randomized to the EW arm completed a standard writing protocol. Before randomization, they completed validated measures of R/S, depressive symptoms, social support, fatigue, and sleep disturbances and one, four, and 10 months after completing the intervention. Writing samples were coded for positive and negative religious coping (RC), and personal (e.g., private prayer) and collective (e.g., church attendance) religious engagement (RE). RESULTS Of the 138 patients, 117 provided at least one writing sample, and 89% of participants made at least one R/S reference with 70% including at least one positive RC statement, and 45.3% revealed personal and 42.3% collective RE. Negative RC was rare (8%). Although positive RC and RE were significantly associated with the R/S Index (P < 0.01), negative RC was not. In prospective analyses, RE was associated with reduced cancer-related symptoms over time (P = 0.04), and negative RC was associated with increased psychological distress over time (P = 0.004). CONCLUSION Behavioral coding of EW samples supported the literature suggesting that positive RC is common among patients with cancer. Although negative RC may be relatively rare, it may be associated with psychological distress.",2020,"Although positive RC and RE were significantly associated with the R/S Index (P<.01), negative RC was not.","['Cancer', 'Participants diagnosed with renal cell carcinoma', 'cancer patients', 'patients with renal cell carcinoma']",['expressive writing arm completed a standard writing protocol'],"['psychological distress', 'R/S, depressive symptoms, social support, fatigue, and sleep disturbances', 'positive and negative religious coping (RC), and personal (e.g., private prayer) and collective (e.g., church attendance) religious engagement (RE']","[{'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0007134', 'cui_str': 'Renal cell carcinoma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0018582', 'cui_str': 'Handwriting'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0815107', 'cui_str': 'Emotional Distress'}, {'cui': 'C0681189', 'cui_str': 'Religiosity'}, {'cui': 'C0237104', 'cui_str': 'Spirituality'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0557075', 'cui_str': 'Has religious belief'}, {'cui': 'C0033175', 'cui_str': 'Private Room'}, {'cui': 'C0392356', 'cui_str': 'Prayer'}, {'cui': 'C0562324', 'cui_str': 'Church'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}]",138.0,0.0481885,"Although positive RC and RE were significantly associated with the R/S Index (P<.01), negative RC was not.","[{'ForeName': 'Santhosshi', 'Initials': 'S', 'LastName': 'Narayanan', 'Affiliation': 'Department of Palliative, Rehabilitation and Integrative Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA. Electronic address: snarayanan2@mdanderson.org.'}, {'ForeName': 'Kathrin', 'Initials': 'K', 'LastName': 'Milbury', 'Affiliation': 'Department of Palliative, Rehabilitation and Integrative Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Wagner', 'Affiliation': 'Department of Palliative, Rehabilitation and Integrative Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Cohen', 'Affiliation': 'Department of Palliative, Rehabilitation and Integrative Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.'}]",Journal of pain and symptom management,['10.1016/j.jpainsymman.2020.04.029'] 78,32387209,"Invited commentary on ""The effect of increased abdominal pressure on internal jugular vein catheterization under ultrasound-guidance on conscious patients: A randomised controlled trial"".",,2020,,['conscious patients'],['internal jugular vein catheterization under ultrasound-guidance'],[],"[{'cui': 'C0234421', 'cui_str': 'Consciousness'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0226550', 'cui_str': 'Internal jugular vein structure'}, {'cui': 'C0007430', 'cui_str': 'Catheterization'}, {'cui': 'C0442973', 'cui_str': 'Ultrasonic guidance procedure'}]",[],,0.0620143,,"[{'ForeName': 'Meng', 'Initials': 'M', 'LastName': 'Tian', 'Affiliation': 'Department of Critical Care Medicine, Qingpu Branch of Zhongshan Hospital, Fudan University, Shanghai, 201700, China.'}, {'ForeName': 'Haiping', 'Initials': 'H', 'LastName': 'Duan', 'Affiliation': 'Department of Anesthesiology, Wuhan Hospital of Traditional Chinese Medicine, Hubei, 430014, China. Electronic address: dhp19651226@126.com.'}]","International journal of surgery (London, England)",['10.1016/j.ijsu.2020.04.073'] 79,32386395,Δ 9 -Tetrahydrocannabinol (THC) impairs visual working memory performance: a randomized crossover trial.,"With the increasing prevalence of legal cannabis use and availability, there is an urgent need to identify cognitive impairments related to its use. It is widely believed that cannabis, or its main psychoactive component Δ 9 -tetrahydrocannabinol (THC), impairs working memory, i.e., the ability to temporarily hold information in mind. However, our review of the literature yielded surprisingly little empirical support for an effect of THC or cannabis on working memory. We thus conducted a study with three main goals: (1) quantify the effect of THC on visual working memory in a well-powered sample, (2) test the potential role of cognitive effects (mind wandering and metacognition) in disrupting working memory, and (3) demonstrate how insufficient sample size and task duration reduce the likelihood of detecting a drug effect. We conducted two double-blind, randomized crossover experiments in which healthy adults (N = 23, 23) performed a reliable and validated visual working memory task (the ""Discrete Whole Report task"", 90 trials) after administration of THC (7.5 and/or 15 mg oral) or placebo. We also assessed self-reported ""mind wandering"" (Exp 1) and metacognitive accuracy about ongoing task performance (Exp 2). THC impaired working memory performance (d = 0.65), increased mind wandering (Exp 1), and decreased metacognitive accuracy about task performance (Exp 2). Thus, our findings indicate that THC does impair visual working memory, and that this impairment may be related to both increased mind wandering and decreased monitoring of task performance. Finally, we used a down-sampling procedure to illustrate the effects of task length and sample size on power to detect the acute effect of THC on working memory.",2020,"THC impaired working memory performance (d = 0.65), increased mind wandering (Exp 1), and decreased metacognitive accuracy about task performance (Exp 2).","['healthy adults (N\u2009=\u200923, 23) performed a']","['THC', 'reliable and validated visual working memory task (the ""Discrete Whole Report task"", 90 trials) after administration of THC', 'placebo', 'Tetrahydrocannabinol (THC']","['metacognitive accuracy about task performance', 'THC impaired working memory performance', 'visual working memory', 'visual working memory performance']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C0039663', 'cui_str': 'dronabinol'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0443299', 'cui_str': 'Separate'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0039333', 'cui_str': 'Task Performance'}, {'cui': 'C0039663', 'cui_str': 'dronabinol'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}]",,0.14689,"THC impaired working memory performance (d = 0.65), increased mind wandering (Exp 1), and decreased metacognitive accuracy about task performance (Exp 2).","[{'ForeName': 'Kirsten C S', 'Initials': 'KCS', 'LastName': 'Adam', 'Affiliation': 'Department of Psychology, University of California San Diego, San Diego, CA, USA. kadam@ucsd.edu.'}, {'ForeName': 'Manoj K', 'Initials': 'MK', 'LastName': 'Doss', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Pabon', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Edward K', 'Initials': 'EK', 'LastName': 'Vogel', 'Affiliation': 'Grossman Institute for Neuroscience, Quantitative Biology, and Human Behavior, University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Harriet', 'Initials': 'H', 'LastName': 'de Wit', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Chicago, Chicago, IL, USA.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-020-0690-3'] 80,32386720,"Raltegravir versus efavirenz in antiretroviral-naive pregnant women living with HIV (NICHD P1081): an open-label, randomised, controlled, phase 4 trial.","BACKGROUND Although antiretroviral regimens containing integrase inhibitors rapidly suppress HIV viral load in non-pregnant adults, few published data from randomised controlled trials have compared the safety and efficacy of any integrase inhibitor to efavirenz when initiated during pregnancy. We compared safety and efficacy of antiretroviral therapy with either raltegravir or efavirenz in late pregnancy. METHODS An open-label, randomised controlled trial was done at 19 hospitals and clinics in Argentina, Brazil, South Africa, Tanzania, Thailand, and the USA. Antiretroviral-naive pregnant women (20-<37 weeks gestation) living with HIV were assigned to antiretroviral regimens containing either raltegravir (400 mg twice daily) or efavirenz (600 mg each night) plus lamivudine 150 mg and zidovudine 300 mg twice daily (or approved alternative backbone regimen), using a web-based, permuted-block randomisation stratified by gestational age and backbone regimen. The primary efficacy outcome was plasma HIV viral load below 200 copies per mL at (or near) delivery. The primary efficacy analysis included all women with a viral load measurement at (or near) delivery who had viral load of at least 200 copies per mL before treatment and no genotypic resistance to any study drugs; secondary analyses eliminated these exclusion criteria. The primary safety analyses included all women who received study drug, and their infants. This trial is registered with Clinicaltrials.gov, number NCT01618305. FINDINGS From Sep 5, 2013, to Dec 11, 2018, 408 women were enrolled (206 raltegravir, 202 efavirenz) and 394 delivered on-study (200 raltegravir, 194 efavirenz); 307 were included in the primary efficacy analysis (153 raltegravir, 154 efavirenz). 144 (94%) women in the raltegravir group and 129 (84%) in the efavirenz group met the primary efficacy outcome (absolute difference 10%, 95% CI 3-18; p=0·0015); the difference primarily occurred among women enrolling later in pregnancy (interaction p=0·040). Frequencies of severe or life-threatening adverse events were similar among mothers (30% in each group; 61 raltegravir, 59 efavirenz) and infants (25% in each group; 50 raltegravir, 48 efavirenz), with no treatment-related deaths. INTERPRETATION Our findings support major guidelines. The integrase inhibitor dolutegravir is currently a preferred regimen for the prevention of perinatal HIV transmission with raltegravir recommended as a preferred or alternative integrase inhibitor for pregnant women living with HIV. FUNDING Eunice Kennedy Shriver National Institute of Child Health and Human Development and National Institute of Allergy and Infectious Diseases.",2020,"Frequencies of severe or life-threatening adverse events were similar among mothers (30% in each group; 61 raltegravir, 59 efavirenz) and infants (25% in each group; 50 raltegravir, 48 efavirenz), with no treatment-related deaths. ","['non-pregnant adults', 'women with a viral load measurement at (or near) delivery who had viral load of at least 200 copies per mL before treatment and no genotypic resistance to any study drugs; secondary analyses eliminated these exclusion criteria', '19 hospitals and clinics in Argentina, Brazil, South Africa, Tanzania, Thailand, and the USA', 'Antiretroviral-naive pregnant women (20-<37 weeks gestation) living with HIV', 'antiretroviral-naive pregnant women living with HIV (NICHD P1081', 'From Sep 5, 2013, to Dec 11, 2018, 408 women were enrolled (206 raltegravir, 202 efavirenz) and 394 delivered on-study (200 raltegravir, 194 efavirenz); 307 were included in the primary efficacy analysis (153 raltegravir, 154 efavirenz', 'pregnant women living with HIV', '144']","['lamivudine 150 mg and zidovudine', 'raltegravir', 'raltegravir or efavirenz', 'efavirenz', 'Raltegravir versus efavirenz']","['Frequencies of severe or life-threatening adverse events', 'safety and efficacy', 'plasma HIV viral load below 200 copies per mL at (or near) delivery']","[{'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1261478', 'cui_str': 'Viral load'}, {'cui': 'C0475806', 'cui_str': '1/3 meter'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0439526', 'cui_str': '/mL'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0017431', 'cui_str': 'Genotype'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0013175', 'cui_str': 'Clinical drug trial'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0003761', 'cui_str': 'Argentina'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}, {'cui': 'C0037712', 'cui_str': 'South Africa'}, {'cui': 'C0039298', 'cui_str': 'Tanzania'}, {'cui': 'C0039725', 'cui_str': 'Thailand'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0599685', 'cui_str': 'Antiretroviral-containing product'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C1513896', 'cui_str': 'National Institute of Child Health and Human Development'}, {'cui': 'C4517769', 'cui_str': '408'}, {'cui': 'C1871526', 'cui_str': 'raltegravir'}, {'cui': 'C0674428', 'cui_str': 'efavirenz'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C5191279', 'cui_str': '154'}, {'cui': 'C4760627', 'cui_str': '144'}]","[{'cui': 'C0987069', 'cui_str': 'Lamivudine 150 MG'}, {'cui': 'C0043474', 'cui_str': 'Zidovudine'}, {'cui': 'C1871526', 'cui_str': 'raltegravir'}, {'cui': 'C0674428', 'cui_str': 'efavirenz'}]","[{'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C3537125', 'cui_str': 'Common terminology criteria for adverse events grade 4'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C1168369', 'cui_str': 'HIV viral load'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0439526', 'cui_str': '/mL'}, {'cui': 'C0475806', 'cui_str': '1/3 meter'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}]",408.0,0.357245,"Frequencies of severe or life-threatening adverse events were similar among mothers (30% in each group; 61 raltegravir, 59 efavirenz) and infants (25% in each group; 50 raltegravir, 48 efavirenz), with no treatment-related deaths. ","[{'ForeName': 'Esaú C', 'Initials': 'EC', 'LastName': 'João', 'Affiliation': 'Infectious Diseases Department, Hospital Federal dos Servidores do Estado, Rio de Janeiro, Brazil. Electronic address: esaujoao@gmail.com.'}, {'ForeName': 'R Leavitt', 'Initials': 'RL', 'LastName': 'Morrison', 'Affiliation': 'Center for Biostatistics in AIDS Research, Harvard T.H. Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Shapiro', 'Affiliation': 'Center for Biostatistics in AIDS Research, Harvard T.H. Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Nahida', 'Initials': 'N', 'LastName': 'Chakhtoura', 'Affiliation': 'Maternal and Pediatric Infectious Diseases Branch, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, MD, USA.'}, {'ForeName': 'Maria Isabel S', 'Initials': 'MIS', 'LastName': 'Gouvèa', 'Affiliation': 'Infectious Diseases Department, Hospital Federal dos Servidores do Estado, Rio de Janeiro, Brazil; Fundação Oswaldo Cruz, Rio de Janeiro, Brazil.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'de Lourdes B Teixeira', 'Affiliation': 'Infectious Diseases Department, Hospital Federal dos Servidores do Estado, Rio de Janeiro, Brazil; Fundação Oswaldo Cruz, Rio de Janeiro, Brazil.'}, {'ForeName': 'Trevon L', 'Initials': 'TL', 'LastName': 'Fuller', 'Affiliation': 'Infectious Diseases Department, Hospital Federal dos Servidores do Estado, Rio de Janeiro, Brazil.'}, {'ForeName': 'Blandina T', 'Initials': 'BT', 'LastName': 'Mmbaga', 'Affiliation': 'Kilimanjaro Christian Medical University College, Moshi, Tanzania.'}, {'ForeName': 'James S', 'Initials': 'JS', 'LastName': 'Ngocho', 'Affiliation': 'Kilimanjaro Christian Medical University College, Moshi, Tanzania.'}, {'ForeName': 'Boniface N', 'Initials': 'BN', 'LastName': 'Njau', 'Affiliation': 'Kilimanjaro Christian Medical University College, Moshi, Tanzania.'}, {'ForeName': 'Avy', 'Initials': 'A', 'LastName': 'Violari', 'Affiliation': 'Perinatal HIV Research Unit, University of the Witwatersrand, Johanesburg, South Africa.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Mathiba', 'Affiliation': 'Perinatal HIV Research Unit, University of the Witwatersrand, Johanesburg, South Africa.'}, {'ForeName': 'Zaakirah', 'Initials': 'Z', 'LastName': 'Essack', 'Affiliation': 'Perinatal HIV Research Unit, University of the Witwatersrand, Johanesburg, South Africa.'}, {'ForeName': 'Jose Henrique S', 'Initials': 'JHS', 'LastName': 'Pilotto', 'Affiliation': 'Hospital Geral de Nova Iguaçu, Nova Iguaçu, Brazil.'}, {'ForeName': 'Luis Felipe', 'Initials': 'LF', 'LastName': 'Moreira', 'Affiliation': 'Hospital Geral de Nova Iguaçu, Nova Iguaçu, Brazil.'}, {'ForeName': 'Maria Jose', 'Initials': 'MJ', 'LastName': 'Rolon', 'Affiliation': 'Fundacion Huesped, Buenos Aires, Argentina.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Cahn', 'Affiliation': 'Fundacion Huesped, Buenos Aires, Argentina.'}, {'ForeName': 'Sinart', 'Initials': 'S', 'LastName': 'Prommas', 'Affiliation': 'Bhumibol Adulyadej Hospital, Bangkok, Thailand.'}, {'ForeName': 'Timothy R', 'Initials': 'TR', 'LastName': 'Cressey', 'Affiliation': 'PHPT/IRD 174, Faculty of Associated Medical Sciences, Chiang Mai University and Chiangrai Prachanukroh Hospital, Chiang Mai, Thailand.'}, {'ForeName': 'Kulkanya', 'Initials': 'K', 'LastName': 'Chokephaibulkit', 'Affiliation': 'Bhumibol Adulyadej Hospital, Bangkok, Thailand.'}, {'ForeName': 'Peerawong', 'Initials': 'P', 'LastName': 'Werarak', 'Affiliation': 'Bhumibol Adulyadej Hospital, Bangkok, Thailand.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Laimon', 'Affiliation': 'Westat, Rockville, MD, USA.'}, {'ForeName': 'Roslyn', 'Initials': 'R', 'LastName': 'Hennessy', 'Affiliation': 'Westat, Rockville, MD, USA.'}, {'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'Frenkel', 'Affiliation': ""University of Washington and Seattle Children's Hospital, Seattle, WA, USA.""}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Anthony', 'Affiliation': 'University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Brookie M', 'Initials': 'BM', 'LastName': 'Best', 'Affiliation': 'University of California San Diego, San Diego, CA, USA.'}, {'ForeName': 'George K', 'Initials': 'GK', 'LastName': 'Siberry', 'Affiliation': 'US Agency for International Development, Washington, DC, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Mirochnick', 'Affiliation': 'Boston University School of Medicine, Boston, MA, USA.'}]",The lancet. HIV,['10.1016/S2352-3018(20)30038-2'] 81,32386721,"Dolutegravir versus efavirenz in women starting HIV therapy in late pregnancy (DolPHIN-2): an open-label, randomised controlled trial.","BACKGROUND Late initiation of HIV antiretroviral therapy (ART) in pregnancy is associated with not achieving viral suppression before giving birth and increased mother-to-child transmission of HIV. We aimed to investigate virological suppression before giving birth with dolutegravir compared with efavirenz, when initiated during the third trimester. METHODS In this randomised, open-label trial, DolPHIN-2, we recruited pregnant women in South Africa and Uganda aged at least 18 years, with untreated but confirmed HIV infection and an estimated gestation of at least 28 weeks, initiating ART in third trimester. Participants were randomly assigned (1:1) to dolutegravir-based or efavirenz-based therapy. HIV viral load was measured 7 days and 28 days after antiretroviral initiation, at 36 weeks' gestation, and at the post-partum visit (0-14 days post partum). The primary efficacy outcome was a viral load of less than 50 copies per mL at the first post-partum visit, and the primary safety outcome was the occurrence of drug-related adverse events in mothers and infants until the post-partum visit. Longer-term follow-up of mothers and infants continues. This study is registered with ClinicalTrials.gov, NCT03249181. FINDINGS Between Jan 23, and Aug 15, 2018, we randomly assigned 268 mothers to dolutegravir (135) or efavirenz (133). All mothers and their infants were included in the safety analysis, and 250 mothers (125 in the dolutegravir group, 125 in the efavirenz group) and their infants in efficacy analyses, by intention-to-treat analyses. The median duration of maternal therapy at birth was 55 days (IQR 33-77). 89 (74%) of 120 in the dolutegravir group had viral loads less than 50 copies per mL, compared with 50 (43%) of 117 in the efavirenz group (risk ratio 1·64, 95% CI 1·31-2·06). 30 (22%) of 137 mothers in the dolutegravir group reported serious adverse events compared with 14 (11%) of 131 in the efavirenz group (p=0·013), particularly surrounding pregnancy and puerperium. We found no differences in births less than 37 weeks and less than 34 weeks gestation (16·4% vs 3·3%, across both groups). Three stillbirths in the dolutegravir group and one in the efavirenz group were considered unrelated to treatment. Three infant HIV infections were detected, all in the dolutegravir group, and were considered likely to be in-utero transmissions. INTERPRETATION Our data support the revision to WHO guidelines recommending the transition to dolutegravir in first-line ART for all adults, regardless of pregnancy or child-bearing potential. FUNDING Unitaid.",2020,"89 (74%) of 120 in the dolutegravir group had viral loads less than 50 copies per mL, compared with 50 (43%) of 117 in the efavirenz group (risk ratio 1·64, 95% CI 1·31-2·06).","['Between Jan 23, and Aug 15, 2018, we randomly assigned 268 mothers to dolutegravir (135) or', 'All mothers and their infants were included in the safety analysis, and 250 mothers (125 in the dolutegravir group, 125 in the efavirenz group) and their infants in efficacy analyses, by intention-to-treat analyses', 'women starting HIV therapy in late pregnancy (DolPHIN-2', 'recruited pregnant women in South Africa and Uganda aged at least 18 years, with untreated but confirmed HIV infection and an estimated gestation of at least 28 weeks, initiating ART in third trimester']","['efavirenz', 'Dolutegravir versus efavirenz', 'dolutegravir-based or efavirenz-based therapy', 'HIV antiretroviral therapy (ART']","['virological suppression', 'viral loads', 'occurrence of drug-related adverse events', 'viral load of less than 50 copies per mL at the first post-partum visit', 'serious adverse events', 'HIV viral load', 'median duration of maternal therapy']","[{'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C4517673', 'cui_str': '268'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C4319551', 'cui_str': '125'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0013005', 'cui_str': 'Dolphin'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0037712', 'cui_str': 'South Africa'}, {'cui': 'C0041573', 'cui_str': 'Uganda'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0019693', 'cui_str': 'Human immunodeficiency virus infection'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0032981', 'cui_str': 'Third trimester pregnancy'}]","[{'cui': 'C0674428', 'cui_str': 'efavirenz'}, {'cui': 'C3253985', 'cui_str': 'dolutegravir'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}]","[{'cui': 'C0205466', 'cui_str': 'Virologic'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0439526', 'cui_str': '/mL'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C1168369', 'cui_str': 'HIV viral load'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]",268.0,0.259954,"89 (74%) of 120 in the dolutegravir group had viral loads less than 50 copies per mL, compared with 50 (43%) of 117 in the efavirenz group (risk ratio 1·64, 95% CI 1·31-2·06).","[{'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Kintu', 'Affiliation': 'Infectious Diseases Institute, College of Health Sciences, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Thokozile R', 'Initials': 'TR', 'LastName': 'Malaba', 'Affiliation': 'Division of Epidemiology and Biostatistics, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Jesca', 'Initials': 'J', 'LastName': 'Nakibuka', 'Affiliation': 'Infectious Diseases Institute, College of Health Sciences, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Christiana', 'Initials': 'C', 'LastName': 'Papamichael', 'Affiliation': 'Tropical Clinical Trials Unit, Liverpool School of Tropical Medicine, Liverpool, UK.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Colbers', 'Affiliation': 'Radboud Institute for Health Sciences, Radboud University Medical Centre, Nijmegen, Netherlands.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Byrne', 'Affiliation': 'Tropical Clinical Trials Unit, Liverpool School of Tropical Medicine, Liverpool, UK.'}, {'ForeName': 'Kay', 'Initials': 'K', 'LastName': 'Seden', 'Affiliation': 'Molecular and Clinical Pharmacology, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Eva Maria', 'Initials': 'EM', 'LastName': 'Hodel', 'Affiliation': 'Molecular and Clinical Pharmacology, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Chen', 'Affiliation': 'Tropical Clinical Trials Unit, Liverpool School of Tropical Medicine, Liverpool, UK.'}, {'ForeName': 'Adelline', 'Initials': 'A', 'LastName': 'Twimukye', 'Affiliation': 'Infectious Diseases Institute, College of Health Sciences, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Josaphat', 'Initials': 'J', 'LastName': 'Byamugisha', 'Affiliation': 'Infectious Diseases Institute, College of Health Sciences, Makerere University, Kampala, Uganda; Department of Gynaecology and Obstetrics School of Medicine, College of Health Sciences, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Reynolds', 'Affiliation': 'Molecular and Clinical Pharmacology, University of Liverpool, Liverpool, UK; Royal Liverpool and Broadgreen University Hospitals NHS Trust, Liverpool, UK.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Watson', 'Affiliation': 'Tropical Clinical Trials Unit, Liverpool School of Tropical Medicine, Liverpool, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Burger', 'Affiliation': 'Radboud Institute for Health Sciences, Radboud University Medical Centre, Nijmegen, Netherlands.'}, {'ForeName': 'Duolao', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': 'Tropical Clinical Trials Unit, Liverpool School of Tropical Medicine, Liverpool, UK.'}, {'ForeName': 'Catriona', 'Initials': 'C', 'LastName': 'Waitt', 'Affiliation': 'Infectious Diseases Institute, College of Health Sciences, Makerere University, Kampala, Uganda; Molecular and Clinical Pharmacology, University of Liverpool, Liverpool, UK; Royal Liverpool and Broadgreen University Hospitals NHS Trust, Liverpool, UK.'}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Taegtmeyer', 'Affiliation': 'International Public Health, Liverpool School of Tropical Medicine, Liverpool, UK.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Orrell', 'Affiliation': 'School of Public Health & Family Medicine, and Desmond Tutu HIV Centre, Department of Medicine, Institute of Infectious Diseases & Molecular Medicine, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Mohammed', 'Initials': 'M', 'LastName': 'Lamorde', 'Affiliation': 'Infectious Diseases Institute, College of Health Sciences, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Landon', 'Initials': 'L', 'LastName': 'Myer', 'Affiliation': 'Division of Epidemiology and Biostatistics, University of Cape Town, Cape Town, South Africa; Centre for Infectious Diseases Epidemiology and Research, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Saye', 'Initials': 'S', 'LastName': 'Khoo', 'Affiliation': 'Molecular and Clinical Pharmacology, University of Liverpool, Liverpool, UK; Royal Liverpool and Broadgreen University Hospitals NHS Trust, Liverpool, UK. Electronic address: khoo@liverpool.ac.uk.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The lancet. HIV,['10.1016/S2352-3018(20)30050-3'] 82,32393551,Alterations in plasma triglycerides and ceramides: links with cardiac function in humans with type 2 diabetes.,"Cardiac dysfunction in T2D is associated with excessive FA uptake, oxidation, and generation of toxic lipid species by the heart. It is not known whether decreasing lipid delivery to the heart can effect improvement in cardiac function in humans with T2D. Thus, our objective was to test the hypothesis that lowering lipid delivery to the heart would result in evidence of decreased ""lipotoxicity,"" improved cardiac function, and salutary effects on plasma biomarkers of cardiovascular risk. Thus, we performed a double-blind randomized placebo-controlled parallel design study of the effects of 12 weeks of fenofibrate-induced lipid lowering on cardiac function, inflammation, and oxidation biomarkers, and on the ratio of two plasma ceramides, Cer d18:1 (4E) (1OH, 3OH)/24:0 and Cer d18:1 (4E) (1OH, 3OH)/16:0 (i.e., ""C24:0/C16:0""), which is associated with decreased risk of cardiac dysfunction and heart failure. Fenofibrate lowered plasma TG and cholesterol but did not improve heart systolic or diastolic function. Fenofibrate treatment lowered the plasma C24:0/C16:0 ceramide ratio and minimally altered oxidative stress markers but did not alter measures of inflammation. Overall, plasma TG lowering correlated with improvement of cardiac relaxation (diastolic function) as measured by tissue Doppler-derived parameter e'. Moreover, lowering the plasma C24:0/C16:0 ceramide ratio was correlated with worse diastolic function. These findings indicate that fenofibrate treatment per se is not sufficient to effect changes in cardiac function; however, decreases in plasma TG may be linked to improved diastolic function. In contrast, decreases in plasma C24:0/C16:0 are linked with worsening cardiac function.",2020,Fenofibrate treatment lowered the plasma C24:0/C16:0 ceramide ratio and minimally altered oxidative stress markers but did not alter measures of inflammation.,"['humans with type 2 diabetes', 'humans with T2D', 'type 2 diabetes (T2D']","['Fenofibrate', 'fenofibrate', 'fenofibrate-induced lipid-lowering', 'placebo']","['plasma C24:0/C16:0', 'risk of cardiac dysfunction and heart failure', 'cardiac function, inflammation and oxidation biomarkers, and on the ratio of two plasma ceramides - Cer d18:1 (4E) (1OH, 3OH)/24:0 \xa0and Cer d18:1 (4E) ', 'cardiac relaxation (diastolic function', 'plasma C24:0/C16:0 ceramide ratio and minimally altered oxidative stress markers', 'plasma TG and cholesterol', 'Cardiac dysfunction', 'heart systolic or diastolic function', 'plasma C24:0/C16:0 ceramide ratio', 'diastolic function']","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}]","[{'cui': 'C0033228', 'cui_str': 'Fenofibrate'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C3277906', 'cui_str': 'Cardiac dysfunction'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0232164', 'cui_str': 'Cardiac function'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0007745', 'cui_str': 'Ceramides'}, {'cui': 'C0237504', 'cui_str': 'CER'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0039155', 'cui_str': 'Systole'}]",,0.0435397,Fenofibrate treatment lowered the plasma C24:0/C16:0 ceramide ratio and minimally altered oxidative stress markers but did not alter measures of inflammation.,"[{'ForeName': 'Linda R', 'Initials': 'LR', 'LastName': 'Peterson', 'Affiliation': 'Division of Cardiology, Department of Medicine, Washington University School of Medicine, St. Louis, MO 63110 lpeterso@wustl.edu.'}, {'ForeName': 'Xuntian', 'Initials': 'X', 'LastName': 'Jiang', 'Affiliation': 'Division of Cardiology, Department of Medicine, Washington University School of Medicine, St. Louis, MO 63110.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Division of Biostatistics, Washington University School of Medicine, St. Louis, MO 63110.'}, {'ForeName': 'Anne C', 'Initials': 'AC', 'LastName': 'Goldberg', 'Affiliation': 'Division of Endocrinology, Department of Medicine, Washington University School of Medicine, St. Louis, MO 63110.'}, {'ForeName': 'Marsha S', 'Initials': 'MS', 'LastName': 'Farmer', 'Affiliation': 'Division of Cardiology, Department of Medicine, Washington University School of Medicine, St. Louis, MO 63110.'}, {'ForeName': 'Daniel S', 'Initials': 'DS', 'LastName': 'Ory', 'Affiliation': 'Division of Cardiology, Department of Medicine, Washington University School of Medicine, St. Louis, MO 63110.'}, {'ForeName': 'Jean E', 'Initials': 'JE', 'LastName': 'Schaffer', 'Affiliation': 'Joslin Diabetes Center, Harvard Medical School, Boston, MA 02215.'}]",Journal of lipid research,['10.1194/jlr.RA120000669'] 83,32332363,Original Research: Exploring the Effects of a Nurse-Initiated Diary Intervention on Post-Critical Care Posttraumatic Stress Disorder.,"BACKGROUND Critical illness survivors may develop posttraumatic stress disorder (PTSD) following critical illness and hospitalization. Left untreated, PTSD may result in poor health outcomes. PURPOSE This study sought to examine the effects of a nurse-initiated diary intervention on PTSD development and symptom severity in critical illness survivors with varying levels of mentation. METHODS The study used a pretest-posttest control group design. Patients who were hospitalized in a critical care unit for more than 24 hours were recruited at a single medical center with two such units. All participants completed a pretest on day 2 of critical care hospitalization; the intervention group participants also received a diary. All participants received a posttest one month after critical care discharge. The variables examined were PTSD severity and symptoms of avoidance, intrusion, and hyperarousal. Variables were measured using the Impact of Event Scale-Revised. Diaries were written by the patient, visitors, and interdisciplinary team members, and kept by the patient. RESULTS A total of 134 participants completed the study. The intervention group participants experienced significantly fewer PTSD symptoms than the control group participants. PTSD was found to be of concern in 35 (26%) of all participants: five in the intervention group and 30 in the control group. CONCLUSIONS For critical illness survivors, a collaborative diary-writing intervention during hospitalization and after discharge can mitigate post-critical care PTSD. Participants who received diaries had a lower incidence of PTSD symptoms than controls; and at follow-up, they indicated that the diary intervention was worthwhile. We recommend the use of collaborative diary writing to help critical illness survivors in working through their experiences.",2020,The intervention group participants experienced significantly fewer PTSD symptoms than the control group participants.,"['Patients who were hospitalized in a critical care unit for more than 24 hours were recruited at a single medical center with two such units', '134 participants completed the study', 'critical illness survivors with varying levels of mentation', 'Post-Critical Care Posttraumatic Stress Disorder']","['Nurse-Initiated Diary Intervention', 'nurse-initiated diary intervention', 'collaborative diary writing']","['PTSD severity and symptoms of avoidance, intrusion, and hyperarousal', 'PTSD symptoms']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C4517565', 'cui_str': '134'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0010337', 'cui_str': 'Care of intensive care unit patient'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}]","[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018582', 'cui_str': 'Handwriting'}]","[{'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C4552570', 'cui_str': 'Hyperarousal'}]",134.0,0.0386469,The intervention group participants experienced significantly fewer PTSD symptoms than the control group participants.,"[{'ForeName': 'Lorrie', 'Initials': 'L', 'LastName': 'Torres', 'Affiliation': 'Lorrie Torres is a hospital nursing supervisor at Tripler Army Medical Center in Honolulu, HI, where Gordon West is deputy chief of the Center for Nursing Science and Clinical Inquiry. Francine Nelson is associate dean of the graduate and doctoral programs in the School of Nursing, University of Phoenix. Contact author: Lorrie Torres, lorrie.c.torres.civ@mail.mil. The authors have disclosed no potential conflicts of interest, financial or otherwise.'}, {'ForeName': 'Francine', 'Initials': 'F', 'LastName': 'Nelson', 'Affiliation': ''}, {'ForeName': 'Gordon', 'Initials': 'G', 'LastName': 'West', 'Affiliation': ''}]",The American journal of nursing,['10.1097/01.NAJ.0000662804.81454.66'] 84,32394772,Effectiveness of a Theory-Based mHealth Intervention for High-Risk Drinking in College Students.,"Background: College students are among the most vulnerable groups to problems associated with high-risk drinking consequences such as illness, injury, sexual abuse, and death. Promising mobile health (mHealth) approaches, such as smartphone (SP) apps, can be used in interventions to address or prevent excessive drinking. Method : The aim of the investigation was to examine the efficacy of a theoretically based mHealth SP app for alcohol intervention in two independent samples ( N   =   379): Mandated participants (Study 1) and voluntary participants (Study 2). Study 1 included a controlled trial with Mandated participants randomized into either an in-person Brief Motivational Interviewing BMI ( n   =   70) or BMI + SP app intervention ( n   =   71). Study 2 included Voluntary participants who participated in either a Control group ( n   =   157) or the BMI + SP app intervention ( n   =   81). Participants in both studies completed baseline and 6-week assessments. Results : In Study 1, peak Blood Alcohol Concentration (BAC) of participants in the in-person BMI group had increased slightly at six weeks, while it had decreased for the app-based BMI + SP group. Study 2 participants using the BMI + SP app reported significant reductions in drinking and consequences; there were no changes in the (AO) Control group. Conclusions: The BMI + SP app was effective with both Mandated and Voluntary participants. Future testing with the BMI + SP app is needed to assess whether reach, adoptability, portability, and sustainability are greater with the mHealth smartphone app for alcohol intervention than in-person approaches.",2020,Study 2 participants using the BMI + SP app reported significant reductions in drinking and consequences; there were no changes in the (AO) Control group. ,"['High-Risk Drinking in College Students', 'two independent samples ( N \u2009 = \u2009 379): Mandated participants (Study 1) and voluntary participants (Study 2', 'Study 2 included Voluntary participants who participated in either a Control group ( n \u2009 = \u2009 157) or the BMI\u2009+\u2009SP app intervention ( n \u2009 = \u2009 81', 'College students']","['Theory-Based mHealth Intervention', 'person Brief Motivational Interviewing BMI ( n \u2009 = \u2009 70) or BMI\u2009+\u2009SP app intervention']","['peak Blood Alcohol Concentration (BAC', 'drinking and consequences']","[{'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}]","[{'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0684262', 'cui_str': 'Blood Alcohol Concentration'}, {'cui': 'C0004599', 'cui_str': 'Bacitracin'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0686907', 'cui_str': 'Consequence of'}]",379.0,0.024291,Study 2 participants using the BMI + SP app reported significant reductions in drinking and consequences; there were no changes in the (AO) Control group. ,"[{'ForeName': 'Donna M', 'Initials': 'DM', 'LastName': 'Kazemi', 'Affiliation': 'College of Health and Human Services, School of Nursing, University of North Carolina at Charlotte, Charlotte, North Carolina, USA.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Borsari', 'Affiliation': 'Department of Psychiatry, Weill Institute for Neurosciences, University of California, San Francisco, California, USA.'}, {'ForeName': 'Maureen J', 'Initials': 'MJ', 'LastName': 'Levine', 'Affiliation': 'Psychology Department, Central Michigan University, Mount Pleasant, Michigan, USA.'}, {'ForeName': 'Shaoyu', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'Department of Mathematics and Statistics, University of North Carolina at Charlotte, Charlotte, North Carolina, USA.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Shehab', 'Affiliation': 'Department of Software and Information Systems, University of North Carolina at Charlotte, Charlotte, North Carolina, USA.'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Fang', 'Affiliation': 'Department of Mathematics and Statistics, University of North Carolina at Charlotte, Charlotte, North Carolina, USA.'}, {'ForeName': 'Jerika C', 'Initials': 'JC', 'LastName': 'Norona', 'Affiliation': 'Addictions Research Program, Mental Illness Research, Education, and Clinical Center (MIRECC), San Francisco VA Health Care System & University of California, San Francisco, California, USA.'}]",Substance use & misuse,['10.1080/10826084.2020.1756851'] 85,31107728,The Association Between Acculturation and Parental Feeding Practices in Families With Overweight and Obese Hispanic/Latino Children.,"This study examines the association between acculturation and parental feeding practices in low-income Latinos. Overweight/obese children (N = 117), aged 5 to 14 years, and their parents were recruited from a rural health clinic. Findings show that more acculturated parents have greater control over their child's eating behavior (P = .04). Parents who perceive their child as having a weight problem also have more control over their child's eating behavior (P = .02). Control measured from regulation of how much and when the child should eat to offering sweets and screen time for good behavior. Results underscore the need for interventions to consider parental acculturation and perceptions of child weight.",2019,Findings show that more acculturated parents have greater control over their child's eating behavior (P = .04).,"['Overweight/obese children (N = 117), aged 5 to 14 years, and their parents were recruited from a rural health clinic', 'Families With Overweight and Obese Hispanic/Latino Children', 'low-income Latinos']",[],[],"[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0035960', 'cui_str': 'Rural health center'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0086528', 'cui_str': 'Latinos'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}]",[],[],117.0,0.0129166,Findings show that more acculturated parents have greater control over their child's eating behavior (P = .04).,"[{'ForeName': 'Cynthia M', 'Initials': 'CM', 'LastName': 'Mojica', 'Affiliation': 'School of Social and Behavioral Health Sciences, College of Public Health and Human Sciences, Oregon State University, Corvallis (Dr Mojica); Department of Epidemiology and Public Health, University of Maryland School of Medicine, Baltimore (Dr Liang); Division of Hospital Medicine, School of Medicine, Oregon Health & Science University, Portland (Dr Foster); and Director, Latino Research Institute, Mexican American and Latina/o Studies, University of Texas at Austin (Dr Parra-Medina).'}, {'ForeName': 'Yuanyuan', 'Initials': 'Y', 'LastName': 'Liang', 'Affiliation': ''}, {'ForeName': 'Byron A', 'Initials': 'BA', 'LastName': 'Foster', 'Affiliation': ''}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Parra-Medina', 'Affiliation': ''}]",Family & community health,['10.1097/FCH.0000000000000226'] 86,32396205,Effect of Psychoeducation on Stress in Parents of Children With Attention-Deficit/Hyperactivity Disorder: A Randomized Controlled Study.,"The current experimental pre-/posttest study sought to determine the effect of psychoeducation on the stress levels of parents of children with attention-deficit/hyperactivity disorder (ADHD). A total of 172 parents participated and were randomly assigned to experimental (n = 86) and control (n = 86) groups. There was no significant difference between mean pretest scores of parents in the experimental and control groups on the Caregiver Stress Scale (p > 0.005); however, significant differences were found between pre- and posttest scores in the experimental group after psychoeducation and at 6-month follow up (p < 0.001). There were also significant differences between pre- and posttest scores and pretest scores and 6-month follow-up scores in the experimental group (p < 0.05). In the light of the findings, psychiatric nurses can use psychoeducation programs to support families of children with ADHD to reduce their stress levels. [Journal of Psychosocial Nursing and Mental Health Services, 58(7), 34-41.].",2020,There were also significant differences between pre- and posttest scores and pretest scores and 6-month follow-up scores in the experimental group (p < 0.05).,"['parents of children with attention-deficit/hyperactivity disorder (ADHD', '172 parents participated and were randomly assigned to experimental (n = 86) and control (n = 86) groups', 'With Attention-Deficit/Hyperactivity Disorder', 'Parents of Children']","['Psychoeducation', 'psychoeducation']","['Caregiver Stress Scale', 'pre- and posttest scores and pretest scores and 6-month follow-up scores']","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C4517601', 'cui_str': '172'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0871175', 'cui_str': 'Psychoeducation'}]","[{'cui': 'C1998980', 'cui_str': 'Caregiver role strain'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]",172.0,0.0289188,There were also significant differences between pre- and posttest scores and pretest scores and 6-month follow-up scores in the experimental group (p < 0.05).,"[{'ForeName': 'Funda', 'Initials': 'F', 'LastName': 'Gümüs', 'Affiliation': ''}, {'ForeName': 'Gül', 'Initials': 'G', 'LastName': 'Ergün', 'Affiliation': ''}, {'ForeName': 'Gül', 'Initials': 'G', 'LastName': 'Dikeç', 'Affiliation': ''}]",Journal of psychosocial nursing and mental health services,['10.3928/02793695-20200506-01'] 87,32396206,Effectiveness of a Nurse-Led Intervention for Adolescents With Problematic Internet Use.,"The current study assessed the effect of an intervention on problematic internet use (PIU), biopsychosocial functioning, and academic performance in 100 adolescents with PIU in grades 9 and 11 in Ernakulam District, Kerala, India. Students from four comparable schools were randomly assigned to experimental and wait-list control groups after being screened for PIU. The experimental group participated in a 10-week intervention and parents of these adolescents were provided with two sessions. The wait-list control group received the intervention after the posttest. A PIU questionnaire, sociodemographic data, internet usage pattern, a biopsychosocial functioning tool, and academic performance were used to assess participants at baseline and immediately after and 3 months postintervention. Findings revealed significant differences in PIU; physical, psychological, and social functioning; and academic performance immediately and 3 months postintervention (p < 0.05). Thus, the intervention was effective in reducing PIU among adolescents and improved their physical, psychological, and social functioning and academic performance. [Journal of Psychosocial Nursing and Mental Health Services, 58(7), 16-26.].",2020,"Findings revealed significant differences in PIU; physical, psychological, and social functioning; and academic performance immediately and 3 months postintervention (p < 0.05).","['Students from four comparable schools', '100 adolescents with PIU in grades 9 and 11 in Ernakulam District, Kerala, India', 'Adolescents With Problematic Internet Use']",['Nurse-Led Intervention'],"['PIU; physical, psychological, and social functioning; and academic performance', 'physical, psychological, and social functioning and academic performance', 'problematic internet use (PIU), biopsychosocial functioning, and academic performance']","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0443018', 'cui_str': 'Kerala'}, {'cui': 'C0021201', 'cui_str': 'India'}]","[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0037395', 'cui_str': 'Social adjustment'}, {'cui': 'C0036373', 'cui_str': 'Academic Test Performance'}]",100.0,0.0373189,"Findings revealed significant differences in PIU; physical, psychological, and social functioning; and academic performance immediately and 3 months postintervention (p < 0.05).","[{'ForeName': 'Preeti', 'Initials': 'P', 'LastName': 'Mathew', 'Affiliation': ''}, {'ForeName': 'Raman', 'Initials': 'R', 'LastName': 'Krishnan', 'Affiliation': ''}, {'ForeName': 'Adhin', 'Initials': 'A', 'LastName': 'Bhaskar', 'Affiliation': ''}]",Journal of psychosocial nursing and mental health services,['10.3928/02793695-20200506-03'] 88,32398420,Omalizumab and other biologics in drug desensitization.,"PURPOSE OF REVIEW Omalizumab has been proposed for controlling adverse reactions during drug desensitization. Our aim is to know the current evidence involving the use of omalizumab in drug-allergy desensitization. RECENT FINDINGS Drug-allergy desensitization is not risk free, but it is a useful procedure and has been applied for drug hypersensitivity reactions with mast cells degranulation through IgE and non-IgE mechanisms. Since 2007, omalizumab has been considered as a potential strategy to prevent adverse reactions.Our review found few case reports and only one randomized double-blind, placebo-controlled study, using different omalizumab regimens prior to drug desensitization. This scarce evidence is insufficient to predict the effectiveness of omalizumab in rapid drug desensitization procedures, but it may be useful in future studies of omalizumab or related next-generation antibodies. SUMMARY Omalizumab or other IgE-targeting biologics, either a fixed dose of 300 mg omalizumab or a dose-related total IgE level and body mass weight may be an option for patients with IgE-mediated or mast cell drug reactions in troublesome desensitization.",2020,"This scarce evidence is insufficient to predict the effectiveness of omalizumab in rapid drug desensitization procedures, but it may be useful in future studies of omalizumab or related next-generation antibodies. ",[],"['omalizumab', 'Omalizumab', 'placebo']",[],[],"[{'cui': 'C0966225', 'cui_str': 'omalizumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],,0.217773,"This scarce evidence is insufficient to predict the effectiveness of omalizumab in rapid drug desensitization procedures, but it may be useful in future studies of omalizumab or related next-generation antibodies. ","[{'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Fernandez', 'Affiliation': 'Allergy Section, Alicante General University Hospital, ISABIAL-UMH.'}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'Ruano-Zaragoza', 'Affiliation': 'Allergy Section, Alicante General University Hospital, Alicante.'}, {'ForeName': 'Natalia', 'Initials': 'N', 'LastName': 'Blanca-Lopez', 'Affiliation': 'Allergy Service, Infanta Leonor University Hospital.'}]",Current opinion in allergy and clinical immunology,['10.1097/ACI.0000000000000648'] 89,32398441,"Dexmedetomidine 2 ppm Is Appropriate for the Enhancement Effect of Local Anesthetic Action of Lidocaine in Inferior Alveolar Nerve Block: A Preliminary, Randomized Cross-over Study.","OBJECTIVE Local anesthesia is essential for pain management in dentistry. The duration of anesthetic action of the addition of 5.0 and 7.5 ppm of dexmedetomidine (DEX) was significantly longer than the addition of adrenaline, and the mean duration of anesthetic action of the addition of 2.5 ppm DEX was also longer than the addition of adrenaline. We hypothesized that it is possible to safely achieve an equal local anesthesia effect as with 1:80,000 adrenaline, without using adrenaline or felypressin, by the addition of <2.5 ppm DEX to the local anesthetic solution. MATERIALS AND METHODS Nineteen healthy volunteers were randomly assigned by a computer to receive 1.8 mL of 1 of 3 drug combinations (1.8% lidocaine with 1.0 ppm [1.8 μg] DEX, lidocaine with 2.0 ppm [3.6 μg] DEX or lidocaine with 1:80,000 [22.5 μg] adrenaline), to produce inferior alveolar nerve block. Pulp latency and lower lip numbness (for assessing onset and duration of anesthesia) were tested, and sedation level, blood pressure, and heart rate were recorded every 2 minutes for 10 minutes, every 5 minutes from 10 to 20 minutes, and every 10 minutes from 20 to 60 minutes. RESULTS Pulp latency increased compared with the baseline, from 4 minutes until 60 minutes; there were no significant intergroup differences at any timepoint. Anesthesia onset did not differ between groups. Anesthesia duration did not differ between groups. Blood pressure and heart rate did not change in any group. Sedation score did not indicate deep sedation in any of the groups. DISCUSSION DEX at a concentration of 1.0 to 2.0 ppm enhances the local anesthetic action of lidocaine. DEX at 2.0 ppm produces similar enhancement of local anesthesia effect as the addition of 1:80,000 adrenaline.",2020,"RESULTS Pulp latency increased compared to baseline, from 4▒min until 60▒min; there were no significant intergroup differences at any time point.","['Nineteen healthy volunteers', 'Inferior Alveolar Nerve Block', 'pain management in dentistry']","['DEX', 'Lidocaine', 'adrenaline or felypressin', 'Dexmedetomidine', 'lidocaine', 'DEX or lidocaine', 'DEX, lidocaine', 'adrenaline', 'lidocaine with 1.0▒ppm (1.8▒μg']","['Pulp latency', 'Anesthesia duration', 'local anesthesia effect', 'duration of anesthetic action', 'Blood pressure and heart rate', 'Sedation score', 'local anesthetic action', 'mean duration of anesthetic action', 'sedation level, blood pressure and heart rate', 'Pulp latency and lower lip numbness']","[{'cui': 'C0450337', 'cui_str': '19'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0394801', 'cui_str': 'Local anesthetic inferior alveolar nerve block'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0011438', 'cui_str': 'Dentistry'}]","[{'cui': 'C0011816', 'cui_str': 'Dextromethorphan'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0015777', 'cui_str': 'Felypressin'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0439187', 'cui_str': 'ppm'}, {'cui': 'C4068742', 'cui_str': '1.8'}]","[{'cui': 'C0011399', 'cui_str': 'Structure of pulp of tooth'}, {'cui': 'C0242465', 'cui_str': 'Response Latency'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0002930', 'cui_str': 'Anesthetics'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0226942', 'cui_str': 'External lower lip'}, {'cui': 'C0020580', 'cui_str': 'Hypesthesia'}]",19.0,0.121872,"RESULTS Pulp latency increased compared to baseline, from 4▒min until 60▒min; there were no significant intergroup differences at any time point.","[{'ForeName': 'Kentaro', 'Initials': 'K', 'LastName': 'Ouchi', 'Affiliation': 'Department of Dental Anesthesiology, Field of Maxillofacial Diagnostic and Surgical Sciences, Faculty of Dental Science, Kyushu University, Fukuoka, Japan.'}]",The Clinical journal of pain,['10.1097/AJP.0000000000000839'] 90,32398443,"Evaluation of the Efficacy of Prolonged Pregabalin Administration Before and After Surgery in Patients Undergoing Arthroscopic Anterior Cruciate Ligament Repair: A Prospective, Randomized, Double-blind Study.","CONTEXT AND OBJECTIVE Reconstruction of the knee ligament causes postoperative pain and delayed rehabilitation. OBJECTIVE The primary objective of this study was to evaluate the effect of a prolonged preoperative and postoperative pregabalin use for arthroscopic anterior cruciate ligament repair. MATERIALS AND METHODS Group 1 (N=25) patients received pregabalin 75 mg/d, and group 2 (N=25) received placebo, 7 days before and 7 days after surgery. Spinal anesthesia was performed using 0.5% hyperbaric bupivacaine (15 mg). The following were evaluated: pain intensity immediately after the surgery, and 12 hours, 24 hours, 1 week, 2 weeks, 1 month, and 2 months after the surgery using a Numerical Rating Scale; dose of postoperative supplementary analgesic for 2 months; time to first analgesic requirement; and side effects during 2 months. For supplementation, the participants received 1 g dipyrone; if there was no pain control, 100 mg ketoprofen was administered; if there was no effect, 100 mg tramadol was administered; and if there was no pain control, 5 mg intravenous morphine was administered until pain control. RESULTS There was no difference between the groups with regard to pain intensity (P=0.077). In the pregabalin group, morphine consumption was lower at 12 hours (P=0.039) and 24 hours (P=0.044) after surgery, and the consumption of tramadol and ketoprofen was lower 24 hours after surgery. There was no significant difference in the incidence of nausea and vomiting. Dizziness was higher in the pregabalin group (group 1=12 patients; group 2=3 patients; P=0.005). DISCUSSION A prolonged preoperative and postoperative pregabalin prescription for anterior cruciate ligament repair decreased the need for supplementary analgesics during the first 24 postoperative hours but increased dizziness.",2020,"In the pregabalin group, morphine consumption was lower 12 hours (P: 0.039), and 24 hours (P: 0.044) after surgery, and the consumption of tramadol and ketoprofen was lower 24 h after surgery.","['arthroscopic anterior cruciate ligament repair', 'Patients', 'Group 1', 'Undergoing Arthroscopic Anterior Cruciate Ligament Repair']","['morphine', 'tramadol', 'hyperbaric bupivacaine', 'pregabalin', 'Prolonged Pregabalin', 'ketoprofen', 'prolonged pre and postoperative pregabalin', 'dipyrone', 'placebo']","['dizziness', 'pain intensity', 'morphine consumption', 'nausea and vomiting, and dizziness', 'time to first analgesic requirement, and side effects']","[{'cui': 'C0078960', 'cui_str': 'Structure of anterior cruciate ligament of knee joint'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}]","[{'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0040610', 'cui_str': 'Tramadol'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0657912', 'cui_str': 'pregabalin'}, {'cui': 'C0022635', 'cui_str': 'Ketoprofen'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0012586', 'cui_str': 'Dipyrone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",25.0,0.135105,"In the pregabalin group, morphine consumption was lower 12 hours (P: 0.039), and 24 hours (P: 0.044) after surgery, and the consumption of tramadol and ketoprofen was lower 24 h after surgery.","[{'ForeName': 'Alexandro F', 'Initials': 'AF', 'LastName': 'Tobias', 'Affiliation': 'Federal University of São Paulo, São Paulo, SP.'}, {'ForeName': 'Ed C R', 'Initials': 'ECR', 'LastName': 'Moura', 'Affiliation': 'Federal University of Maranhão, São Luís, Maranhão, Brazil.'}, {'ForeName': 'Claudio A D O', 'Initials': 'CADO', 'LastName': 'Honda', 'Affiliation': 'Federal University of Maranhão, São Luís, Maranhão, Brazil.'}, {'ForeName': 'Emanuel C', 'Initials': 'EC', 'LastName': 'Pereira', 'Affiliation': 'Federal University of Maranhão, São Luís, Maranhão, Brazil.'}, {'ForeName': 'Caio M B', 'Initials': 'CMB', 'LastName': 'de Oliveira', 'Affiliation': 'Federal University of Maranhão, São Luís, Maranhão, Brazil.'}, {'ForeName': 'Plinio D C', 'Initials': 'PDC', 'LastName': 'Leal', 'Affiliation': 'Federal University of Maranhão, São Luís, Maranhão, Brazil.'}, {'ForeName': 'Rioko K', 'Initials': 'RK', 'LastName': 'Sakata', 'Affiliation': 'Federal University of São Paulo, São Paulo, SP.'}]",The Clinical journal of pain,['10.1097/AJP.0000000000000841'] 91,32396668,Effectiveness of a short web-based film targeting parental oral health knowledge in a well-child care setting.,"Young children rely on their parents with respect to oral health routines. However, parental knowledge on this topic is often insufficient. Well-child care may be an excellent route to reach parents because almost all of them attend. To evaluate the effectiveness of an 8.5 min web-based film about oral health, provided by well-child care, a non-blinded quasi-experimental study was performed. Parents attending well-child care clinics in the Netherlands were assigned to an intervention (n = 88) or control group (n = 41). The control group received care as usual. We measured parental knowledge of oral health with a questionnaire (range of scores 1-12) before and directly after the intervention, and 6 months later, and assessed differences between the intervention and the control group. Parental oral health knowledge improved after watching the film: the intervention group's mean score of 11.1 (SD 1.3) was greater than the mean score of 7.1 (SD 2.0) of the control group (Cohen's d = 2.64). Scores remained higher in the intervention group 6 months after watching the film (mean 9.1, SD 1.3) than before (Cohen's d = 1.25). A web-based educational film delivered in a well-child care setting can be an effective way to address oral health and to improve parental knowledge.",2020,"Scores remained higher in the intervention group 6 months after watching the film (mean 9.1, SD 1.3) than before (Cohen's d = 1.25).",['Parents attending well-child care clinics in the Netherlands'],['short web-based film targeting parental oral health knowledge'],"['parental knowledge of oral health', 'Parental oral health knowledge']","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0686744', 'cui_str': 'Well child'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1704608', 'cui_str': 'Film'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}]","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",,0.0312641,"Scores remained higher in the intervention group 6 months after watching the film (mean 9.1, SD 1.3) than before (Cohen's d = 1.25).","[{'ForeName': 'Deborah Ashley', 'Initials': 'DA', 'LastName': 'Verlinden', 'Affiliation': 'Centre of Dentistry and Oral Hygiene, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Annemarie A', 'Initials': 'AA', 'LastName': 'Schuller', 'Affiliation': 'Centre of Dentistry and Oral Hygiene, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Gijsbert H W', 'Initials': 'GHW', 'LastName': 'Verrips', 'Affiliation': 'Centre of Dentistry and Oral Hygiene, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Sijmen A', 'Initials': 'SA', 'LastName': 'Reijneveld', 'Affiliation': 'Department of Child Health, Netherlands Organization for Applied Scientific Research TNO, Leiden, the Netherlands.'}]",European journal of oral sciences,['10.1111/eos.12700'] 92,32336678,Generating randomized trial evidence to optimize treatment in the COVID-19 pandemic.,,2020,,[],[],[],[],[],[],,0.190025,,"[{'ForeName': 'Matthew P', 'Initials': 'MP', 'LastName': 'Cheng', 'Affiliation': ""Division of Infectious Diseases (Cheng, Lee), Department of Medicine, and Division of Medical Microbiology (Cheng), Department of Laboratory Medicine, McGill University Health Centre; Clinical Trials Platform (Cheng, Lee), McGill Interdisciplinary Initiative in Infection and Immunity, Montréal, Que.; Division of Infectious Diseases (Tan) and MAP Centre for Urban Health Solutions (Tan), St. Michael's Hospital; Department of Medicine (Tan), University of Toronto, Toronto, Ont.; Department of Pediatrics (Murthy), University of British Columbia, Vancouver, BC.""}, {'ForeName': 'Todd C', 'Initials': 'TC', 'LastName': 'Lee', 'Affiliation': ""Division of Infectious Diseases (Cheng, Lee), Department of Medicine, and Division of Medical Microbiology (Cheng), Department of Laboratory Medicine, McGill University Health Centre; Clinical Trials Platform (Cheng, Lee), McGill Interdisciplinary Initiative in Infection and Immunity, Montréal, Que.; Division of Infectious Diseases (Tan) and MAP Centre for Urban Health Solutions (Tan), St. Michael's Hospital; Department of Medicine (Tan), University of Toronto, Toronto, Ont.; Department of Pediatrics (Murthy), University of British Columbia, Vancouver, BC.""}, {'ForeName': 'Darrell H S', 'Initials': 'DHS', 'LastName': 'Tan', 'Affiliation': ""Division of Infectious Diseases (Cheng, Lee), Department of Medicine, and Division of Medical Microbiology (Cheng), Department of Laboratory Medicine, McGill University Health Centre; Clinical Trials Platform (Cheng, Lee), McGill Interdisciplinary Initiative in Infection and Immunity, Montréal, Que.; Division of Infectious Diseases (Tan) and MAP Centre for Urban Health Solutions (Tan), St. Michael's Hospital; Department of Medicine (Tan), University of Toronto, Toronto, Ont.; Department of Pediatrics (Murthy), University of British Columbia, Vancouver, BC.""}, {'ForeName': 'Srinivas', 'Initials': 'S', 'LastName': 'Murthy', 'Affiliation': ""Division of Infectious Diseases (Cheng, Lee), Department of Medicine, and Division of Medical Microbiology (Cheng), Department of Laboratory Medicine, McGill University Health Centre; Clinical Trials Platform (Cheng, Lee), McGill Interdisciplinary Initiative in Infection and Immunity, Montréal, Que.; Division of Infectious Diseases (Tan) and MAP Centre for Urban Health Solutions (Tan), St. Michael's Hospital; Department of Medicine (Tan), University of Toronto, Toronto, Ont.; Department of Pediatrics (Murthy), University of British Columbia, Vancouver, BC srinivas.murthy@cw.bc.ca.""}]",CMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne,['10.1503/cmaj.200438'] 93,32278278,Neural correlates of emotional reactivity and regulation associated with treatment response in a randomized clinical trial for posttraumatic stress disorder.,"Posttraumatic Stress Disorder (PTSD) is a debilitating condition often associated with difficulty in emotion regulation, including reappraising negative emotions. This study assessed neural mechanisms associated with emotion regulation in veterans prior to and following treatment for PTSD. Participants with PTSD and combat exposed controls (CC) completed diagnostic evaluation and underwent fMRI scanning while completing Emotion Regulation Task (ERT) and Emotional Faces Assessment Task (EFAT). Participants with PTSD were randomly assigned to Prolonged Exposure plus placebo (PE+PLB), Sertraline plus enhanced medication management (SERT+EMM), or PE plus SERT (PE+SERT) and repeated diagnostic evaluation and MRI scanning following treatment. The amygdala, dmPFC, and dlPFC were examined as regions of interest. On ERT, veterans with PTSD showed significantly less dmPFC activation than CCs during reappraisal vs emotional maintenance. Within the PTSD group, results demonstrated a significant association between less activation in the dmPFC during emotion reappraisal vs maintenance trials before treatment and greater reductions in symptoms from pre- to post-treatment. During the EFAT, there were no group differences between participants with PTSD and CCs in brain activation, and no relationships between brain function and PTSD symptoms. These findings suggest that less emotional reactivity might potentially reflect less need for recruitment of prefrontal regions when reappraising negative emotion, and is an individual factor associated with better treatment outcome.",2020,"Within the PTSD group, results demonstrated a significant association between less activation in the dmPFC during emotion reappraisal vs maintenance trials before treatment and greater reductions in symptoms from pre- to post-treatment.","['posttraumatic stress disorder', 'Participants with PTSD and combat exposed controls (CC) completed diagnostic evaluation and underwent', 'Participants with PTSD', 'veterans prior to and following treatment for PTSD', 'Posttraumatic Stress Disorder (PTSD']","['fMRI scanning while completing Emotion Regulation Task (ERT) and Emotional Faces Assessment Task (EFAT', 'Prolonged Exposure plus placebo (PE+PLB), Sertraline plus enhanced medication management (SERT+EMM), or PE plus SERT (PE+SERT) and repeated diagnostic evaluation and MRI scanning']","['dmPFC activation', 'amygdala, dmPFC, and dlPFC']","[{'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0074393', 'cui_str': 'Sertraline'}, {'cui': 'C0150270', 'cui_str': 'Management of drug regimen'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}]","[{'cui': 'C0002708', 'cui_str': 'Amygdaloid structure'}, {'cui': 'C4019080', 'cui_str': 'Prefrontal Cortex, Dorsolateral'}]",,0.020995,"Within the PTSD group, results demonstrated a significant association between less activation in the dmPFC during emotion reappraisal vs maintenance trials before treatment and greater reductions in symptoms from pre- to post-treatment.","[{'ForeName': 'Sonalee A', 'Initials': 'SA', 'LastName': 'Joshi', 'Affiliation': 'VA Ann Arbor Healthcare System, 2215 Fuller Road, Ann Arbor, MI 48105, United States; University of Michigan, Department of Psychiatry, 4250 Plymouth Road, Ann Arbor, MI 48109, United States; University of Michigan, Department of Psychology, 530 Church St, Ann Arbor, MI 48109, United States.'}, {'ForeName': 'Elizabeth R', 'Initials': 'ER', 'LastName': 'Duval', 'Affiliation': 'VA Ann Arbor Healthcare System, 2215 Fuller Road, Ann Arbor, MI 48105, United States; University of Michigan, Department of Psychiatry, 4250 Plymouth Road, Ann Arbor, MI 48109, United States.'}, {'ForeName': 'Jony', 'Initials': 'J', 'LastName': 'Sheynin', 'Affiliation': 'VA Ann Arbor Healthcare System, 2215 Fuller Road, Ann Arbor, MI 48105, United States; University of Michigan, Department of Psychiatry, 4250 Plymouth Road, Ann Arbor, MI 48109, United States; Texas A&M University Health Science Center, Department of Psychiatry, 8441 Riverside Parkway, Bryan, TX 77807, United States.'}, {'ForeName': 'Anthony P', 'Initials': 'AP', 'LastName': 'King', 'Affiliation': 'VA Ann Arbor Healthcare System, 2215 Fuller Road, Ann Arbor, MI 48105, United States; University of Michigan, Department of Psychiatry, 4250 Plymouth Road, Ann Arbor, MI 48109, United States.'}, {'ForeName': 'K Luan', 'Initials': 'KL', 'LastName': 'Phan', 'Affiliation': 'Department of Psychiatry and Behavioral Health, The Ohio State University 1670 Upham Drive, Columbus, OH 43210, United States.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Martis', 'Affiliation': 'University of Michigan, Department of Psychiatry, 4250 Plymouth Road, Ann Arbor, MI 48109, United States; VA San Diego Healthcare System, 3350 Villa La Jolla Drive, San Diego, CA 92161, United States; University of California, San Diego, School of Medicine, 9500 Gilman Drive, La Jolla, CA 92037, United States.'}, {'ForeName': 'Katherine E', 'Initials': 'KE', 'LastName': 'Porter', 'Affiliation': 'VA Ann Arbor Healthcare System, 2215 Fuller Road, Ann Arbor, MI 48105, United States; University of Michigan, Department of Psychiatry, 4250 Plymouth Road, Ann Arbor, MI 48109, United States.'}, {'ForeName': 'Israel', 'Initials': 'I', 'LastName': 'Liberzon', 'Affiliation': 'VA Ann Arbor Healthcare System, 2215 Fuller Road, Ann Arbor, MI 48105, United States; Texas A&M University Health Science Center, Department of Psychiatry, 8441 Riverside Parkway, Bryan, TX 77807, United States. Electronic address: liberzon@tamu.edu.'}, {'ForeName': 'Sheila A M', 'Initials': 'SAM', 'LastName': 'Rauch', 'Affiliation': 'Atlanta VA Medical Center, 1670 Clairmont Road, Decatur, GA 30033, United States; Emory University School of Medicine, 12 Executive Park, 3rd Floor, Atlanta, GA 30029, United States.'}]",Psychiatry research. Neuroimaging,['10.1016/j.pscychresns.2020.111062'] 94,32333897,"Safety and efficacy of tocilizumab versus azathioprine in highly relapsing neuromyelitis optica spectrum disorder (TANGO): an open-label, multicentre, randomised, phase 2 trial.","BACKGROUND Azathioprine is used as a first-line treatment to prevent relapses of neuromyelitis optica spectrum disorder (NMOSD). Tocilizumab has been reported to reduce NMOSD disease activity in retrospective case reports. We aimed to compare the safety and efficacy of tocilizumab and azathioprine in patients with highly relapsing NMOSD. METHODS We did an open-label, multicentre, randomised, phase 2 trial at six hospitals in China. We recruited adult patients (aged ≥18 years) with highly relapsing NMOSD diagnosed according to 2015 International Panel for Neuromyelitis Optica Diagnosis criteria, who had an Expanded Disability Status Scale (EDSS) score of 7·5 or lower, and had a history of at least two clinical relapses during the previous 12 months or three relapses during the previous 24 months with at least one relapse within the previous 12 months. Patients were randomly assigned (1:1) to intravenous tocilizumab (8 mg/kg every 4 weeks) or oral azathioprine (2-3 mg/kg per day) by an independent statistician using computer-generated randomisation software with permuted blocks of four. The central review committee, EDSS raters, laboratory personnel, and radiologists were masked to the treatment assignment, but investigators and patients were aware of treatment allocation. The minimum planned duration of treatment was 60 weeks following randomisation. The primary outcome was time to first relapse in the full analysis set, which included all randomly assigned patients who received at least one dose of study drug, and the per-protocol population, which included all patients who used azathioprine or tocilizumab as monotherapy. For the analyses of the primary outcome, the patients were prespecified into two subgroups according to concomitant autoimmune disease status. Safety was assessed in the full analysis set. This study is registered with ClinicalTrials.gov, NCT03350633. FINDINGS Between Nov 1, 2017, and Aug 3, 2018, we enrolled 118 patients, of whom 59 were randomly assigned to tocilizumab and 59 were randomly assigned to azathioprine. All 118 patients received one dose of study drug and were included in the full analysis set. 108 participants were included in the per-protocol analysis (56 in the tocilizumab group and 52 in the azathioprine group). In the full analysis set, median time to the first relapse was longer in the tocilizumab group than the azathioprine group (78·9 weeks [IQR 58·3-90·6] vs 56·7 [32·9-81·7] weeks; p=0·0026). Eight (14%) of 59 patients in the tocilizumab group and 28 (47%) of 59 patients in the azathioprine group had a relapse at the end of the study (hazard ratio [HR] 0·236 [95% CI 0·107-0·518]; p<0·0001). In the per-protocol analysis, 50 (89%) of 56 patients in the tocilizumab group were relapse-free compared with 29 (56%) of 52 patients in the azathioprine group at the end of the study (HR 0·188 [95% CI 0·076-0·463]; p<0·0001); the median time to first relapse was also longer in the tocilizumab group than the azathioprine group (67·2 weeks [IQR 47·9-77·9] vs 38·0 [23·6-64·9]; p<0·0001). In the prespecified subgroup analysis of the full analysis set stratified by concomitant autoimmune diseases, among patients without concomitant autoimmune diseases, three (9%) of 34 patients in the tocilizumab group and 13 (35%) of 37 patients in the azathioprine group had relapsed by the end of the study. Among patients with concomitant autoimmune diseases, a lower proportion of patients in the tocilizumab group had a relapse than in the azathioprine group (five [20%] of 25 patients vs 15 [68%] of 22 patients; HR 0·192 [95% CI 0·070-0·531]; p=0·0004). 57 (97%) of 59 patients in the tocilizumab group and 56 (95%) of 59 patients in the azathioprine group had adverse events. Treatment-associated adverse events occurred in 36 (61%) of 59 tocilizumab-treated patients and 49 (83%) of 59 azathioprine-treated patients. One death (2%) occurred in the tocilizumab group and one (2%) in the azathioprine group, but neither of the deaths were treatment-related. INTERPRETATION Tocilizumab significantly reduced the risk of a subsequent NMOSD relapse compared with azathioprine. Tocilizumab might therefore be another safe and effective treatment to prevent relapses in patients with NMOSD. FUNDING Tianjin Medical University, Advanced Innovation Center for Human Brain Protection, National Key Research and Development Program of China, National Science Foundation of China.",2020,Treatment-associated adverse events occurred in 36 (61%) of 59 tocilizumab-treated patients and 49 (83%) of 59 azathioprine-treated patients.,"['Between Nov 1, 2017, and Aug 3, 2018, we enrolled 118 patients, of whom 59 were randomly assigned to', 'patients with highly relapsing NMOSD', 'adult patients (aged ≥18 years) with highly relapsing NMOSD diagnosed according to 2015 International Panel for Neuromyelitis Optica', '108 participants were included in the per-protocol analysis (56 in the tocilizumab group and 52 in the azathioprine group', '0·236', 'six hospitals in China', 'highly relapsing neuromyelitis optica spectrum disorder (TANGO', 'patients with NMOSD', 'All 118 patients received one dose of study drug and were included in the full analysis set']","['oral azathioprine', 'Azathioprine', 'Tocilizumab', 'tocilizumab', 'azathioprine', 'intravenous tocilizumab', 'tocilizumab and azathioprine', 'azathioprine or tocilizumab as monotherapy']","['median time to first relapse', 'adverse events', 'Safety', 'risk of a subsequent NMOSD relapse', 'Expanded Disability Status Scale (EDSS) score', 'time to first relapse', 'Safety and efficacy', 'relapse-free', 'safety and efficacy', 'relapse', 'median time to the first relapse']","[{'cui': 'C0949920', 'cui_str': 'Norovirus'}, {'cui': 'C4517542', 'cui_str': '118'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0027873', 'cui_str': 'Neuromyelitis optica'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0441833', 'cui_str': 'Groups'}, {'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C1609165', 'cui_str': 'tocilizumab'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0004482', 'cui_str': 'Azathioprine'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0013175', 'cui_str': 'Clinical drug trial'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0004482', 'cui_str': 'Azathioprine'}, {'cui': 'C1609165', 'cui_str': 'tocilizumab'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C4087551', 'cui_str': 'Neuromyelitis optica spectrum disorder relapse'}, {'cui': 'C0451246', 'cui_str': 'Kurtzke multiple sclerosis rating scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0332296', 'cui_str': 'Free of'}]",118.0,0.235391,Treatment-associated adverse events occurred in 36 (61%) of 59 tocilizumab-treated patients and 49 (83%) of 59 azathioprine-treated patients.,"[{'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Zhang', 'Affiliation': 'Department of Neurology, Tianjin Neurological Institute, Tianjin Medical University General Hospital, Tianjin Medical University, Tianjin, China; China National Clinical Research Center for Neurological Diseases, Advanced Innovation Center for Human Brain Protection, Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Meini', 'Initials': 'M', 'LastName': 'Zhang', 'Affiliation': 'Department of Neurology, First Hospital of Shanxi Medical University, Taiyuan, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Qiu', 'Affiliation': 'Department of Neurology, Third Hospital of Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Hongshan', 'Initials': 'H', 'LastName': 'Ma', 'Affiliation': ""The Third People's Hospital of Datong, School of Clinical Medicine, Shanxi Medical University, Datong, China.""}, {'ForeName': 'Xinghu', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'China National Clinical Research Center for Neurological Diseases, Advanced Innovation Center for Human Brain Protection, Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Zilong', 'Initials': 'Z', 'LastName': 'Zhu', 'Affiliation': 'Department of Neurology, Huanhu Hospital, Tianjin, China.'}, {'ForeName': 'Chun-Sheng', 'Initials': 'CS', 'LastName': 'Yang', 'Affiliation': 'Department of Neurology, Tianjin Neurological Institute, Tianjin Medical University General Hospital, Tianjin Medical University, Tianjin, China.'}, {'ForeName': 'Dongmei', 'Initials': 'D', 'LastName': 'Jia', 'Affiliation': 'Department of Neurology, Tianjin Neurological Institute, Tianjin Medical University General Hospital, Tianjin Medical University, Tianjin, China.'}, {'ForeName': 'Tian-Xiang', 'Initials': 'TX', 'LastName': 'Zhang', 'Affiliation': 'Department of Neurology, Tianjin Neurological Institute, Tianjin Medical University General Hospital, Tianjin Medical University, Tianjin, China.'}, {'ForeName': 'Meng', 'Initials': 'M', 'LastName': 'Yuan', 'Affiliation': 'Department of Neurology, Tianjin Neurological Institute, Tianjin Medical University General Hospital, Tianjin Medical University, Tianjin, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Feng', 'Affiliation': 'Department of Neurology, Tianjin Neurological Institute, Tianjin Medical University General Hospital, Tianjin Medical University, Tianjin, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': 'Department of Neurology, Tianjin Neurological Institute, Tianjin Medical University General Hospital, Tianjin Medical University, Tianjin, China.'}, {'ForeName': 'Wenli', 'Initials': 'W', 'LastName': 'Lu', 'Affiliation': 'School of Public Health, Tianjin Medical University, Tianjin, China.'}, {'ForeName': 'Chunshui', 'Initials': 'C', 'LastName': 'Yu', 'Affiliation': 'Department of Neurology, Tianjin Neurological Institute, Tianjin Medical University General Hospital, Tianjin Medical University, Tianjin, China; School of Radiology, Tianjin Medical University, Tianjin, China.'}, {'ForeName': 'Jeffrey L', 'Initials': 'JL', 'LastName': 'Bennett', 'Affiliation': 'Departments of Neurology and Ophthalmology, Programs in Neuroscience and Immunology, University of Colorado, Denver School of Medicine, Aurora, CO, USA.'}, {'ForeName': 'Fu-Dong', 'Initials': 'FD', 'LastName': 'Shi', 'Affiliation': 'Department of Neurology, Tianjin Neurological Institute, Tianjin Medical University General Hospital, Tianjin Medical University, Tianjin, China; China National Clinical Research Center for Neurological Diseases, Advanced Innovation Center for Human Brain Protection, Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China. Electronic address: fshi@tmu.edu.cn.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Neurology,['10.1016/S1474-4422(20)30070-3'] 95,32333898,"Safety and efficacy of satralizumab monotherapy in neuromyelitis optica spectrum disorder: a randomised, double-blind, multicentre, placebo-controlled phase 3 trial.","BACKGROUND Satralizumab, a humanised monoclonal antibody targeting the interleukin-6 receptor, reduced the risk of relapse in patients with neuromyelitis optica spectrum disorder (NMOSD) when added to immunosuppressant therapy. This study assessed the safety and efficacy of satralizumab monotherapy in patients with the disorder. METHODS In this phase 3, double-blind, placebo-controlled, parallel-group trial, we enrolled adults aged 18-74 years with aquaporin-4 antibody seropositive or seronegative NMOSD at 44 investigational sites in 13 countries. Eligible participants had experienced at least one documented NMOSD attack or relapse in the past 12 months and had a score of 6·5 or less on the Expanded Disability Status Scale. Exclusion criteria included clinical relapse 30 days or fewer before baseline. Participants were randomly assigned (2:1) to receive satralizumab 120 mg or visually matched placebo subcutaneously at weeks 0, 2, 4, and every 4 weeks thereafter. Taking immunosuppressants concomitantly was prohibited. The primary endpoint was time to the first protocol-defined relapse, based on the intention-to-treat population and analysed with stratification for two randomisation factors (previous therapy for prevention of attacks and nature of the most recent attack). Safety was assessed in all participants who received at least one dose of satralizumab or placebo. The double-blind phase was due to last until 44 protocol-defined relapses occurred or 1·5 years after random assignment of the last patient enrolled, whichever occurred first; participants could enter an open-label phase after the occurrence of a protocol-defined relapse or at the end of the double-blind phase. The study is registered with ClinicalTrials.gov, NCT02073279. FINDINGS 95 (57%) of 168 screened participants were randomly assigned to treatment (63 to satralizumab; 32 to placebo) between Aug 5, 2014, and April 2, 2017. Protocol-defined relapses occurred in 19 (30%) patients receiving satralizumab and 16 (50%) receiving placebo (hazard ratio 0·45, 95% CI 0·23-0·89; p=0·018). 473·9 adverse events per 100 patient-years occurred in the satralizumab group, as did 495·2 per 100 patient-years in the placebo group; the incidence of serious adverse events and adverse events leading to withdrawal was similar between groups. INTERPRETATION Satralizumab monotherapy reduced the rate of NMOSD relapse compared with placebo in the overall trial population, with a favourable safety profile. The patient population included a ratio of aquaporin-4 antibody seropositive and seronegative patients that was reflective of clinical practice. Satralizumab has the potential to become a valuable treatment option for patients with NMOSD. FUNDING Chugai Pharmaceutical (Roche).",2020,"BACKGROUND Satralizumab, a humanised monoclonal antibody targeting the interleukin-6 receptor, reduced the risk of relapse in patients with neuromyelitis optica spectrum disorder (NMOSD) when added to immunosuppressant therapy.","['enrolled adults aged 18-74 years with aquaporin-4 antibody seropositive or seronegative NMOSD at 44 investigational sites in 13 countries', 'patients with neuromyelitis optica spectrum disorder (NMOSD', 'neuromyelitis optica spectrum disorder', 'patients with the disorder', '95 (57%) of 168 screened participants', 'patients with NMOSD']","['placebo', 'satralizumab or placebo', 'Satralizumab', 'satralizumab monotherapy', 'satralizumab 120 mg or visually matched placebo']","['473·9 adverse events', 'Expanded Disability Status Scale', 'rate of NMOSD relapse', 'Safety', 'Protocol-defined relapses', 'Safety and efficacy', 'NMOSD attack or relapse', 'safety and efficacy', 'incidence of serious adverse events and adverse events leading to withdrawal', 'time to the first protocol-defined relapse, based on the intention-to-treat population']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C2919772', 'cui_str': 'Aquaporin-4 antibody'}, {'cui': 'C0521143', 'cui_str': 'Seropositive'}, {'cui': 'C0521144', 'cui_str': 'Seronegative'}, {'cui': 'C0027873', 'cui_str': 'Neuromyelitis optica'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C4319556', 'cui_str': '168'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0336766', 'cui_str': 'Matches'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0451246', 'cui_str': 'Kurtzke multiple sclerosis rating scale'}, {'cui': 'C4087551', 'cui_str': 'Neuromyelitis optica spectrum disorder relapse'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C4087481', 'cui_str': 'Neuromyelitis optica spectrum disorder attack'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0032659', 'cui_str': 'Population'}]",,0.694031,"BACKGROUND Satralizumab, a humanised monoclonal antibody targeting the interleukin-6 receptor, reduced the risk of relapse in patients with neuromyelitis optica spectrum disorder (NMOSD) when added to immunosuppressant therapy.","[{'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Traboulsee', 'Affiliation': 'Department of Neurology, University of British Columbia, Vancouver, BC, Canada. Electronic address: t.traboulsee@ubc.ca.'}, {'ForeName': 'Benjamin M', 'Initials': 'BM', 'LastName': 'Greenberg', 'Affiliation': 'Department of Neurology and Neurotherapeutics, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Jeffrey L', 'Initials': 'JL', 'LastName': 'Bennett', 'Affiliation': 'Departments of Neurology and Ophthalmology, University of Colorado School of Medicine, Aurora, CO, USA.'}, {'ForeName': 'Lech', 'Initials': 'L', 'LastName': 'Szczechowski', 'Affiliation': 'Silesian Centre of Neurology, Medical University of Silesia, Katowice, Poland.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Fox', 'Affiliation': 'Central Texas Neurology Consultants, Round Rock, TX, USA.'}, {'ForeName': 'Svitlana', 'Initials': 'S', 'LastName': 'Shkrobot', 'Affiliation': 'Department of Neurology, Psychiatry, Narcology and Medical Psychology, Ternopil State Medical University, Ternopil, Ukraine.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Yamamura', 'Affiliation': 'Department of Immunology, National Institute of Neuroscience, National Center of Neurology and Psychiatry, Tokyo, Japan.'}, {'ForeName': 'Yusuke', 'Initials': 'Y', 'LastName': 'Terada', 'Affiliation': 'Chugai Pharmaceutical, Tokyo, Japan.'}, {'ForeName': 'Yuichi', 'Initials': 'Y', 'LastName': 'Kawata', 'Affiliation': 'Chugai Pharmaceutical, Tokyo, Japan.'}, {'ForeName': 'Padraig', 'Initials': 'P', 'LastName': 'Wright', 'Affiliation': 'Chugai Pharma Europe, London, UK.'}, {'ForeName': 'Athos', 'Initials': 'A', 'LastName': 'Gianella-Borradori', 'Affiliation': 'Servier Laboratories, Suresnes, Paris, France.'}, {'ForeName': 'Hideki', 'Initials': 'H', 'LastName': 'Garren', 'Affiliation': 'Genentech, South San Francisco, CA, USA.'}, {'ForeName': 'Brian G', 'Initials': 'BG', 'LastName': 'Weinshenker', 'Affiliation': 'Department of Neurology, Mayo Clinic, Rochester, MN, USA.'}]",The Lancet. Neurology,['10.1016/S1474-4422(20)30078-8'] 96,32338063,"Efficacy and safety of DBPR108 monotherapy in patients with type 2 diabetes: a 12-week, randomized, double-blind, placebo-controlled, phase II clinical trial.","Objective: DBPR108, a novel dipeptidyl-peptidase-4 inhibitor, has shown great antihyperglycemic effect in animal models. This study was to evaluate the efficacy and safety of DBPR108 monotherapy in type 2 diabetes mellitus (T2DM). Methods: This was a 12-week, double-blind, placebo-controlled phase II clinical trial. The newly diagnosed or inadequately controlled untreated T2DM patients were randomized to receive 50, 100, 200 mg DBPR108 or placebo in a ratio of 1:1:1:1. The primary efficacy outcome was HbA1c change from baseline to week 12. Relevant secondary efficacy parameters and safety were assessed. The clinical trial registration is NCT04124484. Results: Overall, 271 of the 276 randomized patients, who received 50 mg ( n  = 68), 100 mg ( n  = 67), 200 mg ( n  = 69) DBPR108 or placebo ( n  = 67), were included in full analysis set. At week 12, HbA1c change from baseline was -0.04 ± 0.77 in placebo group, -0.51 ± 0.71, -0.75 ± 0.73, and -0.57 ± 0.78 (%, p  < .001 vs. placebo) in 50, 100, and 200 mg DBPR108 groups, respectively. Since week 4, DBPR108 monotherapy resulted in significant improvements in secondary efficacy parameters. At end of 12-week treatment, the goal of HbA1c ≤7% was achieved in 29.85, 58.82, 55.22, and 47.83% of the patients in placebo, 50, 100, and 200 mg DBPR108 groups, respectively. The incidence of adverse events did not show significant difference between DBPR108 and placebo except mild hypoglycemia in DBPR108 200 mg group. Conclusions: The study results support DBPR108 100 mg once daily as the primary dosing regimen for T2DM patients in phase III development program.",2020,The incidence of adverse events did not show significant difference between DBPR108 and placebo except mild hypoglycemia in DBPR108 200 mg group.,"['type 2 diabetes mellitus (T2DM', 'newly diagnosed or inadequately controlled untreated T2DM patients', 'patients with type 2 diabetes', 'T2DM patients in phase III development program']","['DBPR108 or placebo', 'placebo', 'DBPR108 monotherapy']","['secondary efficacy parameters', 'efficacy and safety', 'mild hypoglycemia', 'incidence of adverse events', 'Efficacy and safety']","[{'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0033333', 'cui_str': 'Program development'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",276.0,0.553928,The incidence of adverse events did not show significant difference between DBPR108 and placebo except mild hypoglycemia in DBPR108 200 mg group.,"[{'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'Peking University First Hospital, Beijing, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Yao', 'Affiliation': 'Peking University First Hospital, Beijing, China.'}, {'ForeName': 'Xiaohui', 'Initials': 'X', 'LastName': 'Guo', 'Affiliation': 'Peking University First Hospital, Beijing, China.'}, {'ForeName': 'Yushan', 'Initials': 'Y', 'LastName': 'Guo', 'Affiliation': 'Affiliated Hospital of Beihua University, Jilin, China.'}, {'ForeName': 'Chaoli', 'Initials': 'C', 'LastName': 'Yan', 'Affiliation': 'The Affiliated Hospital of Inner Mongolia Medical University, Inner Mongolia, China.'}, {'ForeName': 'Kuanzhi', 'Initials': 'K', 'LastName': 'Liu', 'Affiliation': 'The Third Hospital of Hebei Medical University, Hebei, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'The Third Affiliated Hospital of Guangzhou Medical University, Guangdong, China.'}, {'ForeName': 'Xiaoyue', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': ""The First People's Hospital of Yueyang, Hunan, China.""}, {'ForeName': 'Hongmei', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Emergency General Hospital, Beijing, China.'}, {'ForeName': 'Zhongyuan', 'Initials': 'Z', 'LastName': 'Wen', 'Affiliation': 'Renmin Hospital of Wuhan University, Hubei, China.'}, {'ForeName': 'Xinling', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': ""Xinjiang Uiger Municipal People's Hospital, Xinjiang, China.""}, {'ForeName': 'Shuangqing', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'West China Hospital, Sichuan University, Sichuan, China.'}, {'ForeName': 'Xinhua', 'Initials': 'X', 'LastName': 'Xiao', 'Affiliation': 'Peking Union Medical College Hospital, Beijing, China.'}, {'ForeName': 'Weijuan', 'Initials': 'W', 'LastName': 'Liu', 'Affiliation': 'Chongqing Three Gorges Central Hospital, Chongqing, China.'}, {'ForeName': 'Ziling', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Inner Mongolia Baogang Hospital, Inner Mongolia, China.'}, {'ForeName': 'Lihui', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'The second Hospital of Hebei Medical University, Hebei, China.'}, {'ForeName': 'Shiying', 'Initials': 'S', 'LastName': 'Shao', 'Affiliation': 'Tongji Medical College of Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Shandong', 'Initials': 'S', 'LastName': 'Ye', 'Affiliation': 'Anhui Provincial Hospital, Anhui, China.'}, {'ForeName': 'Guijun', 'Initials': 'G', 'LastName': 'Qin', 'Affiliation': 'The First Affiliated Hospital of Zhengzhou University, Henan, China.'}, {'ForeName': 'Yiming', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Huashan Hospital Affiliated to Fudan University, Shanghai, China.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Li', 'Affiliation': ""Jining First People's Hospital, Shandong, China.""}, {'ForeName': 'Xiaomei', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'The First Affiliated Hospital of Bengbu Medical College, Anhui, China.'}, {'ForeName': 'Xuefeng', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Shiyan Taihe Hospital, Hubei, China.'}, {'ForeName': 'Yongde', 'Initials': 'Y', 'LastName': 'Peng', 'Affiliation': 'Shanghai General Hospital, Shanghai, China.'}, {'ForeName': 'Hongyan', 'Initials': 'H', 'LastName': 'Deng', 'Affiliation': 'Wuhan Puai Hospital, Hubei, China.'}, {'ForeName': 'Xiangjin', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': '900 Hospital of the Joint Logistics Support Force of Chinese PLA, Fujian, China.'}, {'ForeName': 'Ligang', 'Initials': 'L', 'LastName': 'Zhou', 'Affiliation': 'Shanghai Pudong Hospital, Shanghai, China.'}, {'ForeName': 'Yanli', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': 'CSPC Zhongqi Pharmaceutical Technology (Shijiazhuang) Co, Ltd, Hebei, China.'}, {'ForeName': 'Mengya', 'Initials': 'M', 'LastName': 'Cao', 'Affiliation': 'CSPC Zhongqi Pharmaceutical Technology (Shijiazhuang) Co, Ltd, Hebei, China.'}, {'ForeName': 'Xuefang', 'Initials': 'X', 'LastName': 'Xia', 'Affiliation': 'CSPC Zhongqi Pharmaceutical Technology (Shijiazhuang) Co, Ltd, Hebei, China.'}, {'ForeName': 'Mingbiao', 'Initials': 'M', 'LastName': 'Shi', 'Affiliation': 'CSPC Zhongqi Pharmaceutical Technology (Shijiazhuang) Co, Ltd, Hebei, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Dou', 'Affiliation': 'CSPC Zhongqi Pharmaceutical Technology (Shijiazhuang) Co, Ltd, Hebei, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Yuan', 'Affiliation': 'CSPC Zhongqi Pharmaceutical Technology (Shijiazhuang) Co, Ltd, Hebei, China.'}]",Current medical research and opinion,['10.1080/03007995.2020.1761311'] 97,32314841,Rapid pacing and high-frequency jet ventilation additively improve catheter stability during atrial fibrillation ablation.,"INTRODUCTION Catheter stability during atrial fibrillation ablation is associated with higher ablation success rates. Rapid cardiac pacing and high-frequency jet ventilation (HFJV) independently improve catheter stability. Simultaneous modulation of cardiac and respiratory motion has not been previously studied. The objective of this study was to determine the effect of simultaneous heart rate and respiratory rate modulation on catheter stability. METHODS Forty patients undergoing paroxysmal atrial fibrillation ablation received ablation lesions at 15 prespecified locations (12 left atria, 3 right atria). Patients were randomly assigned to undergo rapid atrial pacing for either the first or the second half of each lesion. Within each group, half of the patients received HFJV and the other half standard ventilation. Contact force and ablation data for all lesions were compared among the study groups. Standard deviation of contact force was the primary endpoint defined to examine contact force variability. RESULTS Lesions with no pacing and standard ventilation had the greatest contact force standard deviation (5.86 ± 3.08 g), compared to lesions with pacing and standard ventilation (5.45 ± 3.28 g; P < .01) or to lesions with no pacing and HFJV (4.92 ± 3.00 g; P < .01). Lesions with both pacing and HFJV had the greatest reduction in contact force standard deviation (4.35 ± 2.81 g; P < .01), confirming an additive benefit of each maneuver. Pacing and HFJV together was also associated with a reduction in the proportion of lesions with excessive maximum contact force (P < .001). DISCUSSION Rapid pacing and HFJV additively improve catheter stability. Simultaneous pacing with HFJV further improves catheter stability over pacing or HFJV alone to optimize ablation lesions.",2020,"Lesions with both pacing and HFJV had the greatest reduction in contact force standard deviation, (4.35+2.81g, p<0.01), confirming an additive benefit of each maneuver.","['Forty patients undergoing paroxysmal atrial fibrillation ablation received ablation lesions at 15 pre-specified locations (12 left atria, 3 right atria']","['Rapid Pacing and High Frequency Jet Ventilation', 'HFJV', 'Rapid cardiac pacing and high frequency jet ventilation (HFJV', 'rapid atrial pacing', 'HFJV and half standard ventilation']","['greatest contact force standard deviation', 'lesions with pacing and standard ventilation', 'catheter stability', 'Catheter Stability']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0235480', 'cui_str': 'Paroxysmal atrial fibrillation'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0450429', 'cui_str': 'Location'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0018792', 'cui_str': 'Atrial structure'}, {'cui': 'C0205090', 'cui_str': 'Right'}]","[{'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0562458', 'cui_str': 'Pacing up and down'}, {'cui': 'C0019540', 'cui_str': 'High frequency jet ventilation'}, {'cui': 'C0199640', 'cui_str': 'Cardiac pacing'}, {'cui': 'C0018792', 'cui_str': 'Atrial structure'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}]","[{'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0562458', 'cui_str': 'Pacing up and down'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0205360', 'cui_str': 'Stable'}]",40.0,0.0253215,"Lesions with both pacing and HFJV had the greatest reduction in contact force standard deviation, (4.35+2.81g, p<0.01), confirming an additive benefit of each maneuver.","[{'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Aizer', 'Affiliation': 'The New York University Cardiac Electrophysiology Service, New York University School of Medicine, New York University Langone Health, New York, New York.'}, {'ForeName': 'Jessica K', 'Initials': 'JK', 'LastName': 'Qiu', 'Affiliation': 'The New York University Cardiac Electrophysiology Service, New York University School of Medicine, New York University Langone Health, New York, New York.'}, {'ForeName': 'Austin V', 'Initials': 'AV', 'LastName': 'Cheng', 'Affiliation': 'The New York University Cardiac Electrophysiology Service, New York University School of Medicine, New York University Langone Health, New York, New York.'}, {'ForeName': 'Patrick B', 'Initials': 'PB', 'LastName': 'Wu', 'Affiliation': 'The New York University Cardiac Electrophysiology Service, New York University School of Medicine, New York University Langone Health, New York, New York.'}, {'ForeName': 'Chirag R', 'Initials': 'CR', 'LastName': 'Barbhaiya', 'Affiliation': 'The New York University Cardiac Electrophysiology Service, New York University School of Medicine, New York University Langone Health, New York, New York.'}, {'ForeName': 'Lior', 'Initials': 'L', 'LastName': 'Jankelson', 'Affiliation': 'The New York University Cardiac Electrophysiology Service, New York University School of Medicine, New York University Langone Health, New York, New York.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Linton', 'Affiliation': 'The New York University Cardiac Electrophysiology Service, New York University School of Medicine, New York University Langone Health, New York, New York.'}, {'ForeName': 'Scott A', 'Initials': 'SA', 'LastName': 'Bernstein', 'Affiliation': 'The New York University Cardiac Electrophysiology Service, New York University School of Medicine, New York University Langone Health, New York, New York.'}, {'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Park', 'Affiliation': 'The New York University Cardiac Electrophysiology Service, New York University School of Medicine, New York University Langone Health, New York, New York.'}, {'ForeName': 'Douglas S', 'Initials': 'DS', 'LastName': 'Holmes', 'Affiliation': 'The New York University Cardiac Electrophysiology Service, New York University School of Medicine, New York University Langone Health, New York, New York.'}, {'ForeName': 'Larry A', 'Initials': 'LA', 'LastName': 'Chinitz', 'Affiliation': 'The New York University Cardiac Electrophysiology Service, New York University School of Medicine, New York University Langone Health, New York, New York.'}]",Journal of cardiovascular electrophysiology,['10.1111/jce.14507'] 98,32315769,"Commentary on ""Visualising improved peritoneal perfusion at lower intra-abdominal pressure by fluorescent imaging during laparoscopic surgery: A randomised controlled study"".",,2020,,[],['Visualising improved peritoneal perfusion at lower intra-abdominal pressure by fluorescent imaging during laparoscopic surgery'],[],[],"[{'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0031153', 'cui_str': 'Peritoneum (serous membrane) structure'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C1512911', 'cui_str': 'Intraabdominal route'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0303920', 'cui_str': 'Fluorescent stain'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C0751429', 'cui_str': 'Laparoscopic surgery'}]",[],,0.158978,,"[{'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'von Bechtolsheim', 'Affiliation': 'Department of Visceral, Thoracic- and Vascular Surgery, University Hospital Carl Gustav Carus, Technical University Dresden, Fetscherstraße 74, 01307, Dresden, Germany. Electronic address: felix.bechtolsheim@uniklinikum-dresden.de.'}, {'ForeName': 'Marius', 'Initials': 'M', 'LastName': 'Distler', 'Affiliation': 'Department of Visceral, Thoracic- and Vascular Surgery, University Hospital Carl Gustav Carus, Technical University Dresden, Fetscherstraße 74, 01307, Dresden, Germany.'}]","International journal of surgery (London, England)",['10.1016/j.ijsu.2020.03.086'] 99,32334622,Exploring the effects of deep brain stimulation and vision on tremor in Parkinson's disease - benefits from objective methods.,"BACKGROUND Tremor is a cardinal symptom of Parkinson's disease (PD) that may cause severe disability. As such, objective methods to determine the exact characteristics of the tremor may improve the evaluation of therapy. This methodology study aims to validate the utility of two objective technical methods of recording Parkinsonian tremor and evaluate their ability to determine the effects of Deep Brain Stimulation (DBS) of the subthalamic nucleus and of vision. METHODS We studied 10 patients with idiopathic PD, who were responsive to L -Dopa and had more than 1 year use of bilateral subthalamic nucleus stimulation. The patients did not have to display visible tremor to be included in the study. Tremor was recorded with two objective methods, a force platform and a 3 dimensional (3D) motion capture system that tracked movements in four key proximal sections of the body (knee, hip, shoulder and head). They were assessed after an overnight withdrawal of anti-PD medications with DBS ON and OFF and with eyes open and closed during unperturbed and perturbed stance with randomized calf vibration, using a randomized test order design. RESULTS Tremor was detected with the Unified Parkinson's Disease Rating Scale (UPDRS) in 6 of 10 patients but only distally (hands and feet) with DBS OFF. With the force platform and the 3D motion capture system, tremor was detected in 6 of 10 and 7 of 10 patients respectively, mostly in DBS OFF but also with DBS ON in some patients. The 3D motion capture system revealed that more than one body section was usually affected by tremor and that the tremor amplitude was non-uniform, but the frequency almost identical, across sites. DBS reduced tremor amplitude non-uniformly across the body. Visual input mostly reduced tremor amplitude with DBS ON. CONCLUSIONS Technical recording methods offer objective and sensitive detection of tremor that provide detailed characteristics such as peak amplitude, frequency and distribution pattern, and thus, provide information that can guide the optimization of treatments. Both methods detected the effects of DBS and visual input but the 3D motion system was more versatile in that it could detail the presence and properties of tremor at individual body sections.",2020,"With the force platform and the 3D motion capture system, tremor was detected in 6 of 10 and 7 of 10 patients respectively, mostly in DBS OFF but also with DBS ON in some patients.","['10 patients with idiopathic PD, who were responsive to L -Dopa and had more than 1 year use of bilateral subthalamic nucleus stimulation']","['deep brain stimulation and vision', 'Deep Brain Stimulation (DBS', 'DBS ON and OFF and with eyes open and closed during unperturbed and perturbed stance with randomized calf vibration']","[""Unified Parkinson's Disease Rating Scale (UPDRS""]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0205342', 'cui_str': 'Responsive'}, {'cui': 'C0023570', 'cui_str': 'Levodopa'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0152355', 'cui_str': 'Nucleus of Luys'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}]","[{'cui': 'C0394162', 'cui_str': 'Deep brain stimulation'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0266574', 'cui_str': 'Ablepharon'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0230445', 'cui_str': 'Structure of calf of leg'}, {'cui': 'C0455941', 'cui_str': 'Vibration - treatment'}]","[{'cui': 'C3639721', 'cui_str': 'UPDRS Panel'}]",10.0,0.0634744,"With the force platform and the 3D motion capture system, tremor was detected in 6 of 10 and 7 of 10 patients respectively, mostly in DBS OFF but also with DBS ON in some patients.","[{'ForeName': 'Per-Anders', 'Initials': 'PA', 'LastName': 'Fransson', 'Affiliation': 'Department of Clinical Sciences, Lund University, S-221 85, Lund, Sweden. Per-Anders.Fransson@med.lu.se.'}, {'ForeName': 'Maria H', 'Initials': 'MH', 'LastName': 'Nilsson', 'Affiliation': 'Department of Health Sciences, Lund University, S-221 85, Lund, Sweden.'}, {'ForeName': 'Diederick C', 'Initials': 'DC', 'LastName': 'Niehorster', 'Affiliation': 'Lund University Humanities Lab, Lund University, S-221 00, Lund, Sweden.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Nyström', 'Affiliation': 'Lund University Humanities Lab, Lund University, S-221 00, Lund, Sweden.'}, {'ForeName': 'Stig', 'Initials': 'S', 'LastName': 'Rehncrona', 'Affiliation': 'Department of Neurosurgery, Lund University, S-221 85, Lund, Sweden.'}, {'ForeName': 'Fredrik', 'Initials': 'F', 'LastName': 'Tjernström', 'Affiliation': 'Department of Clinical Sciences, Lund University, S-221 85, Lund, Sweden.'}, {'ForeName': 'Måns', 'Initials': 'M', 'LastName': 'Magnusson', 'Affiliation': 'Department of Clinical Sciences, Lund University, S-221 85, Lund, Sweden.'}, {'ForeName': 'Rolf', 'Initials': 'R', 'LastName': 'Johansson', 'Affiliation': 'Department of Automatic Control, Lund University, S-221 00, Lund, Sweden.'}, {'ForeName': 'Mitesh', 'Initials': 'M', 'LastName': 'Patel', 'Affiliation': 'Division of Brain Sciences, Imperial College London, London, W6 8RF, UK.'}]",Journal of neuroengineering and rehabilitation,['10.1186/s12984-020-00677-3'] 100,32311521,"A Commentary on the article: Visualising improved peritoneal perfusion at lower intra-abdominal pressure by fluorescent imaging during laparoscopic surgery: A randomised controlled study, Int J Surg. 2020 Mar 17. pii: S1743-9191(20)30231-4. doi: 10.1016/j.ijsu.2020.03.019.",,2020,,['pii'],['fluorescent imaging during laparoscopic surgery'],['peritoneal perfusion'],"[{'cui': 'C2983694', 'cui_str': 'Personally Identifiable Information'}]","[{'cui': 'C0303920', 'cui_str': 'Fluorescent stain'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C0751429', 'cui_str': 'Laparoscopic surgery'}]","[{'cui': 'C0031153', 'cui_str': 'Peritoneum (serous membrane) structure'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}]",,0.0758544,,"[{'ForeName': 'Faramarz', 'Initials': 'F', 'LastName': 'Karimian', 'Affiliation': 'Tehran University of Medical Sciences-TUMS, Iran. Electronic address: faramarz.karimian@gmail.com.'}]","International journal of surgery (London, England)",['10.1016/j.ijsu.2020.03.074'] 101,32304828,"IMPROVE, a community-based exercise intervention versus support group to improve functional and health outcomes among older African American and non-Hispanic White breast cancer survivors from diverse socioeconomic backgrounds: Rationale, design and methods.","BACKGROUND African Americans (AA) and socioeconomic status (SES) disadvantaged older breast cancer survivors (BCS) are more likely to experience poor functional and health outcomes. However, few studies have evaluated the putative beneficial effects of exercise on these outcomes in older racial minority and SES-disadvantaged BCS. METHODS This is a mixed-methods study that includes a randomized-controlled trial, ""IMPROVE"", to evaluate a group-based exercise intervention compared to a support group program in older BCS, followed by post-intervention semi-structured interviews to evaluate the intervention. The trial aims to recruit 220 BCS with 55 in each of four strata defined by race (AA versus Non-Hispanic Whites) and SES (disadvantaged vs. non-disadvantaged). Participants are ≥65 years old and within five years of treatment completion for stage I-III breast cancer. Participants are randomized to a 52-week, three sessions/week, one-hour/session, moderate intensity aerobic and resistance group exercise intervention, (n = 110) or a 52-week, one hour/week, support group intervention [attention-control arm], (n = 110). The first 20 weeks of both programs are supervised and the last 32 weeks, unsupervised. The primary outcome is the change in Short Physical Performance Battery (SPPB) Scores at 20 weeks from baseline, between the two arms. Secondary outcomes include change in SPPB scores at 52 weeks, change in body composition and biomarkers, at 20 and 52 weeks from baseline, between arms. DISCUSSION Results of the trial may contribute to a better understanding of factors associated with recruitment, and acceptability, and will inform future exercise programs to optimally improve health outcomes for older BCS.",2020,"Secondary outcomes include change in SPPB scores at 52 weeks, change in body composition and biomarkers, at 20 and 52 weeks from baseline, between arms. ","['older African American and non-Hispanic White breast cancer survivors from diverse socioeconomic backgrounds', '220 BCS with 55 in each of four strata defined by race (AA versus Non-Hispanic Whites) and SES (disadvantaged vs. non-disadvantaged', 'African Americans (AA) and socioeconomic status (SES) disadvantaged older breast cancer survivors (BCS', 'Participants are ≥65\u202fyears old and within five years of treatment completion for stage I-III breast cancer']","['moderate intensity aerobic and resistance group exercise intervention', 'exercise intervention', 'community-based exercise intervention']","['functional and health outcomes', 'change in Short Physical Performance Battery (SPPB) Scores', 'change in SPPB scores at 52\u202fweeks, change in body composition and biomarkers']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0037464', 'cui_str': 'Factors, Socioeconomic'}, {'cui': 'C4517650', 'cui_str': '220'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0034510', 'cui_str': 'Racial group'}, {'cui': 'C0086996', 'cui_str': 'Socioeconomic Status'}, {'cui': 'C0012613', 'cui_str': 'Disadvantaged'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580352', 'cui_str': 'Treatment completed'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1'}, {'cui': 'C0439070', 'cui_str': 'III'}]","[{'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C1276393', 'cui_str': 'Group exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C4075461', 'cui_str': 'Short Physical Performance Battery'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C4075289', 'cui_str': 'Short Physical Performance Battery score'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}]",220.0,0.0741916,"Secondary outcomes include change in SPPB scores at 52 weeks, change in body composition and biomarkers, at 20 and 52 weeks from baseline, between arms. ","[{'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Owusu', 'Affiliation': 'Division of Hematology/Oncology, Department of Medicine, Case Western Reserve University (CWRU) School of Medicine, Cleveland, OH, United States of America; Case Comprehensive Cancer Center, Case Western Reserve University, Cleveland, OH, United States of America. Electronic address: Cynthia.owusu@case.edu.'}, {'ForeName': 'Nora L', 'Initials': 'NL', 'LastName': 'Nock', 'Affiliation': 'Case Comprehensive Cancer Center, Case Western Reserve University, Cleveland, OH, United States of America; Department of Population and Quantitative Health Sciences, CWRU, Cleveland, OH, United States of America.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Hergenroeder', 'Affiliation': 'Department of Medicine, Division of Hematology/Oncology, MetroHealth Medical Center, Cleveland, OH, United States of America.'}, {'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Austin', 'Affiliation': 'The Gathering Place, Beachwood, OH, United States of America.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Bennet', 'Affiliation': 'The Gathering Place, Beachwood, OH, United States of America.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Cerne', 'Affiliation': 'The Gathering Place, Beachwood, OH, United States of America.'}, {'ForeName': 'Halle', 'Initials': 'H', 'LastName': 'Moore', 'Affiliation': 'Cleveland Clinic, Department of Hematology/Oncology, Cleveland, OH, United States of America.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Petkac', 'Affiliation': 'University Hospitals of Cleveland, Cleveland, OH, United States of America.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Schluchter', 'Affiliation': 'Case Comprehensive Cancer Center, Case Western Reserve University, Cleveland, OH, United States of America; Department of Population and Quantitative Health Sciences, CWRU, Cleveland, OH, United States of America.'}, {'ForeName': 'Kathryn H', 'Initials': 'KH', 'LastName': 'Schmitz', 'Affiliation': 'Penn State University College of Medicine, Hershey, PA, United States of America.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Webb-Hooper', 'Affiliation': 'Case Comprehensive Cancer Center, Case Western Reserve University, Cleveland, OH, United States of America.'}, {'ForeName': 'Lindsay', 'Initials': 'L', 'LastName': 'Atkins', 'Affiliation': 'California Baptist University, Riverside, CA, United States of America.'}, {'ForeName': 'Oghenerukeme', 'Initials': 'O', 'LastName': 'Asagba', 'Affiliation': 'West Virginia University School of Medicine, Morgantown, WV, United States of America.'}, {'ForeName': 'Leonard', 'Initials': 'L', 'LastName': 'Wimbley', 'Affiliation': 'Division of Hematology/Oncology, Department of Medicine, Case Western Reserve University (CWRU) School of Medicine, Cleveland, OH, United States of America.'}, {'ForeName': 'Nathan A', 'Initials': 'NA', 'LastName': 'Berger', 'Affiliation': 'Case Comprehensive Cancer Center, Case Western Reserve University, Cleveland, OH, United States of America.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106001'] 102,32229324,Neurocognitive processes in d-cycloserine augmented single-session exposure therapy for anxiety: A randomized placebo-controlled trial.,"Drugs targeting N-methyl-d-aspartate (NMDA) receptors and the ability to learn new associations have been proposed as adjunct treatments to boost the success of exposure therapy for anxiety disorders. However, the effects of the NMDA partial agonist d-cycloserine on psychological treatment have been mixed. We investigated potential neurocognitive mechanisms underlying the clinical effects of d-cycloserine-augmented exposure, to inform the optimal combination of this and similar agents with psychological treatment. Panic disorder patients were randomised to single-dose d-cycloserine (250 mg; N = 17) or matching placebo (N = 16) 2hrs before one session of exposure therapy. Neurocognitive markers were assessed one day after treatment, including reaction-time based threat bias for fearful faces (primary outcome) and amygdala response to threat (secondary outcome). Clinical symptom severity was measured the day before and after treatment, and at 1- and 6-months follow-up (secondary outcome). d-cycloserine was associated with greater clinical recovery at 1-month follow-up than placebo (d-cyloserine 71% vs placebo 25%), with the placebo group matching the clinical gains of the d-cycloserine group during 6-months follow-up (d-cycloserine 71% vs placebo 44%). One day after treatment, threat bias for fearful faces and amygdala threat response was lower in the drug compared to placebo group. Lower amygdala magnitude predicted greater clinical improvement during follow-up across groups. While this experimental study is of a preliminary nature due to the limited sample size, these findings highlight a neurocognitive potential mechanism by which d-cycloserine may exert its augmentative effects on psychological treatment and bring forward a marker that may help understand and facilitate development of combination treatments for anxiety. (d-cycloserine Augmented CBT for Panic Disorder; clinicaltrials.gov; NCT01680107).",2020,"One day after treatment, threat bias for fearful faces and amygdala threat response was lower in the drug compared to placebo group.","['Panic disorder patients', 'anxiety']","['placebo', 'matching placebo', 'cycloserine augmented single-session exposure therapy', 'NMDA partial agonist d-cycloserine', 'single-dose d-cycloserine']","['threat bias for fearful faces and amygdala threat response', 'Clinical symptom severity', 'clinical recovery', 'reaction-time based threat bias for fearful faces (primary outcome) and amygdala response to threat (secondary outcome', 'Neurocognitive markers', 'Neurocognitive processes']","[{'cui': 'C0030319', 'cui_str': 'Panic Disorder'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0010590', 'cui_str': 'Cycloserine'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0870527', 'cui_str': 'Exposure Therapy'}, {'cui': 'C0079883', 'cui_str': 'N-Methyl-D-aspartate'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}]","[{'cui': 'C0005346', 'cui_str': 'Bias'}, {'cui': 'C0458278', 'cui_str': 'Fearful (qualifier value)'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C0002708', 'cui_str': 'Amygdaloid Body'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity (finding)'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C4521054', 'cui_str': 'Process (qualifier value)'}]",,0.358042,"One day after treatment, threat bias for fearful faces and amygdala threat response was lower in the drug compared to placebo group.","[{'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Reinecke', 'Affiliation': 'Department of Psychiatry, University of Oxford, Oxford, UK. Electronic address: andrea.reinecke@psych.ox.ac.uk.'}, {'ForeName': 'Alecia', 'Initials': 'A', 'LastName': 'Nickless', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK; School of Chemistry, University of Bristol, Bristol, UK.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Browning', 'Affiliation': 'Department of Psychiatry, University of Oxford, Oxford, UK; Oxford Health NHS Foundation Trust, Warneford Hospital, Oxford, UK.'}, {'ForeName': 'Catherine J', 'Initials': 'CJ', 'LastName': 'Harmer', 'Affiliation': 'Department of Psychiatry, University of Oxford, Oxford, UK; Oxford Health NHS Foundation Trust, Warneford Hospital, Oxford, UK.'}]",Behaviour research and therapy,['10.1016/j.brat.2020.103607'] 103,32232363,Acute Effects of Glucagon on Reproductive Hormone Secretion in Healthy Men.,"CONTEXT Glucagon increases energy expenditure; consequently, glucagon receptor agonists are in development for the treatment of obesity. Obesity negatively affects the reproductive axis, and hypogonadism itself can exacerbate weight gain. Therefore, knowledge of the effects of glucagon receptor agonism on reproductive hormones is important for developing therapeutics for obesity; but reports in the literature about the effects of glucagon receptor agonism on the reproductive axis are conflicting. OBJECTIVE The objective of this work is to investigate the effect of glucagon administration on reproductive hormone secretion in healthy young men. DESIGN A single-blinded, randomized, placebo-controlled crossover study was conducted. SETTING The setting of this study was the Clinical Research Facility, Imperial College Healthcare NHS Trust. PARTICIPANTS Eighteen healthy eugonadal men (mean ± SEM: age 25.1 ± 1.0 years; body mass index 22.5 ± 0.4 kg/m2; testosterone 21.2 ± 1.2 nmol/L) participated in this study. INTERVENTION An 8-hour intravenous infusion of 2 pmol/kg/min glucagon or rate-matched vehicle infusion was administered. MAIN OUTCOME MEASURES Luteinizing hormone (LH) pulsatility; LH, follicle-stimulating hormone (FSH), and testosterone levels were measured. RESULTS Although glucagon administration induced metabolic effects (insulin area under the curve: vehicle 1065 ± 292 min.µU/mL vs glucagon 2098 ± 358 min.µU/mL, P < .001), it did not affect LH pulsatility (number of LH pulses/500 min: vehicle 4.7 ± 0.4, glucagon 4.2 ± 0.4, P = .22). Additionally, there were no significant differences in circulating LH, FSH, or testosterone levels during glucagon administration compared with vehicle administration. CONCLUSIONS Acute administration of a metabolically active dose of glucagon does not alter reproductive hormone secretion in healthy men. These data are important for the continued development of glucagon-based treatments for obesity.",2020,"Although glucagon administration induced metabolic effects (insulin AUC: vehicle 1065±292min.µU/mL vs glucagon 2098±358min.µU/mL, p<0.0001), it did not affect LH pulsatility (number of LH pulses/500min: vehicle 4.7±0.4, glucagon 4.2±0.4, p=0.22).","['Healthy Men', 'Eighteen healthy eugonadal men (mean±SEM', 'healthy men', 'healthy young men']","['placebo', 'glucagon receptor agonism', 'glucagon administration', '2pmol/kg/min glucagon or rate-matched vehicle infusion', 'Glucagon', 'glucagon']","['circulating LH, FSH or testosterone levels', 'LH pulsatility', 'Reproductive Hormone Secretion', 'metabolic effects', 'reproductive hormone secretion', 'Luteinizing hormone (LH) pulsatility; LH, follicle stimulating hormone (FSH) and testosterone levels']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C3715206', 'cui_str': 'Eighteen'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0061352', 'cui_str': 'Glucagon Receptor'}, {'cui': 'C0876232', 'cui_str': 'glucagon recombinant'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C1532757', 'cui_str': 'kg/min'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0042444', 'cui_str': 'Drug vehicle (substance)'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}]","[{'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}, {'cui': 'C0733758', 'cui_str': 'Follicle Stimulating Hormone'}, {'cui': 'C0523912', 'cui_str': 'Testosterone measurement (procedure)'}, {'cui': 'C0577317', 'cui_str': 'Pulsatility (attribute)'}, {'cui': 'C1167871', 'cui_str': 'Reproductive hormone'}, {'cui': 'C0036537', 'cui_str': 'Secretions'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0023607', 'cui_str': 'Luteinizing Hormone'}]",18.0,0.287042,"Although glucagon administration induced metabolic effects (insulin AUC: vehicle 1065±292min.µU/mL vs glucagon 2098±358min.µU/mL, p<0.0001), it did not affect LH pulsatility (number of LH pulses/500min: vehicle 4.7±0.4, glucagon 4.2±0.4, p=0.22).","[{'ForeName': 'Chioma', 'Initials': 'C', 'LastName': 'Izzi-Engbeaya', 'Affiliation': 'Section of Endocrinology and Investigative Medicine, Imperial College London, London, UK.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Jones', 'Affiliation': 'Section of Endocrinology and Investigative Medicine, Imperial College London, London, UK.'}, {'ForeName': 'Yoshibye', 'Initials': 'Y', 'LastName': 'Crustna', 'Affiliation': 'Section of Endocrinology and Investigative Medicine, Imperial College London, London, UK.'}, {'ForeName': 'Pratibha C', 'Initials': 'PC', 'LastName': 'Machenahalli', 'Affiliation': 'Section of Endocrinology and Investigative Medicine, Imperial College London, London, UK.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Papadopoulou', 'Affiliation': 'Section of Endocrinology and Investigative Medicine, Imperial College London, London, UK.'}, {'ForeName': 'Manish', 'Initials': 'M', 'LastName': 'Modi', 'Affiliation': 'Section of Endocrinology and Investigative Medicine, Imperial College London, London, UK.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Starikova', 'Affiliation': 'Section of Endocrinology and Investigative Medicine, Imperial College London, London, UK.'}, {'ForeName': 'Derek', 'Initials': 'D', 'LastName': 'Chan', 'Affiliation': 'Section of Endocrinology and Investigative Medicine, Imperial College London, London, UK.'}, {'ForeName': 'Pei Chia', 'Initials': 'PC', 'LastName': 'Eng', 'Affiliation': 'Section of Endocrinology and Investigative Medicine, Imperial College London, London, UK.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Phylactou', 'Affiliation': 'Section of Endocrinology and Investigative Medicine, Imperial College London, London, UK.'}, {'ForeName': 'Risheka', 'Initials': 'R', 'LastName': 'Ratnasabapathy', 'Affiliation': 'Section of Endocrinology and Investigative Medicine, Imperial College London, London, UK.'}, {'ForeName': 'Edouard', 'Initials': 'E', 'LastName': 'Mills', 'Affiliation': 'Section of Endocrinology and Investigative Medicine, Imperial College London, London, UK.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': 'Section of Endocrinology and Investigative Medicine, Imperial College London, London, UK.'}, {'ForeName': 'Ewa', 'Initials': 'E', 'LastName': 'Pacuszka', 'Affiliation': 'Section of Endocrinology and Investigative Medicine, Imperial College London, London, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Bech', 'Affiliation': 'Section of Endocrinology and Investigative Medicine, Imperial College London, London, UK.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Minnion', 'Affiliation': 'Section of Endocrinology and Investigative Medicine, Imperial College London, London, UK.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Tharakan', 'Affiliation': 'Section of Endocrinology and Investigative Medicine, Imperial College London, London, UK.'}, {'ForeName': 'Tricia', 'Initials': 'T', 'LastName': 'Tan', 'Affiliation': 'Section of Endocrinology and Investigative Medicine, Imperial College London, London, UK.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Veldhuis', 'Affiliation': 'Department of Internal Medicine, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Abbara', 'Affiliation': 'Section of Endocrinology and Investigative Medicine, Imperial College London, London, UK.'}, {'ForeName': 'Alexander N', 'Initials': 'AN', 'LastName': 'Comninos', 'Affiliation': 'Section of Endocrinology and Investigative Medicine, Imperial College London, London, UK.'}, {'ForeName': 'Waljit S', 'Initials': 'WS', 'LastName': 'Dhillo', 'Affiliation': 'Section of Endocrinology and Investigative Medicine, Imperial College London, London, UK.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgaa164'] 104,30661082,Dried blood spot compared to plasma measurements of blood-based biomarkers of brain injury in neonatal encephalopathy.,"BACKGROUND Data correlating dried blood spots (DBS) and plasma concentrations for neonatal biomarkers of brain injury are lacking. We hypothesized that candidate biomarker levels determined from DBS can serve as a reliable surrogate for plasma levels. METHODS In the context of a phase II multi-center trial evaluating erythropoietin for neuroprotection in neonatal encephalopathy (NE), DBS were collected at enrollment ( < 24 h), day 2, 4, and 5. Plasma was collected with the first and last DBS. The relationship between paired DBS-plasma determinations of brain-specific proteins and cytokines was assessed by correlation and Bland-Altman analyses. For analytes with consistent DBS-plasma associations, DBS-derived biomarker levels were related to brain injury by MRI and 1-year outcomes. RESULTS We enrolled 50 newborns with NE. While S100B protein, tumor necrosis factor α, interleukin (IL)1 β, IL-6, IL-8 demonstrated significant DBS-plasma correlations, Bland-Altman plots demonstrated that the methods are not interchangeable, with a 2 to 4-fold error between measurements. No significant relationships were found between DBS levels of TNFα, IL-6, and IL-8 and outcomes. CONCLUSION Further work is needed to optimize elution and assay methods before using DBS specimens as a reliable surrogate for plasma levels of candidate brain injury biomarkers in NE.",2019,"While S100B protein, tumor necrosis factor α, interleukin (IL)1 β, IL-6, IL-8 demonstrated significant DBS-plasma correlations,",['50 newborns with NE'],['Dried blood spot'],"['Plasma', 'DBS levels of TNFα, IL-6, and IL-8 and outcomes', 'While S100B protein, tumor necrosis factor α, interleukin (IL)1 β, IL-6, IL-8 demonstrated significant DBS-plasma correlations']","[{'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0235820', 'cui_str': 'Neonatal encephalopathy'}]","[{'cui': 'C0011682', 'cui_str': 'Desiccation - action'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0011682', 'cui_str': 'Desiccation - action'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0021755', 'cui_str': 'Interleukin-1'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0010101', 'cui_str': 'Correlation Studies'}]",50.0,0.106799,"While S100B protein, tumor necrosis factor α, interleukin (IL)1 β, IL-6, IL-8 demonstrated significant DBS-plasma correlations,","[{'ForeName': 'An N', 'Initials': 'AN', 'LastName': 'Massaro', 'Affiliation': ""Pediatrics - Division of Neonatology, Children's National Health Systems and The George Washington University School of Medicine, Washington, DC, USA. anguyenm@cnmc.org.""}, {'ForeName': 'Yvonne W', 'Initials': 'YW', 'LastName': 'Wu', 'Affiliation': 'Neurology and Pediatrics, UCSF, San Francisco, CA, USA.'}, {'ForeName': 'Theo K', 'Initials': 'TK', 'LastName': 'Bammler', 'Affiliation': 'Department of Environmental & Occupational Health Sciences, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'James W', 'Initials': 'JW', 'LastName': 'MacDonald', 'Affiliation': 'Department of Environmental & Occupational Health Sciences, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Mathur', 'Affiliation': 'Pediatrics, Washington University School of Medicine, St. Louis, MO, USA.'}, {'ForeName': 'Taeun', 'Initials': 'T', 'LastName': 'Chang', 'Affiliation': ""Neurology and Pediatrics, Children's National Health Systems and The George Washington University School of Medicine, Washington, DC, USA.""}, {'ForeName': 'Dennis', 'Initials': 'D', 'LastName': 'Mayock', 'Affiliation': 'Pediatrics-Division of Neonatology, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Sarah B', 'Initials': 'SB', 'LastName': 'Mulkey', 'Affiliation': ""Neurology and Pediatrics, Children's National Health Systems and The George Washington University School of Medicine, Washington, DC, USA.""}, {'ForeName': 'Krisa', 'Initials': 'K', 'LastName': 'van Meurs', 'Affiliation': 'Pediatrics, Stanford, Palo Alto, CA, USA.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Afsharinejad', 'Affiliation': 'Department of Environmental & Occupational Health Sciences, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Sandra E', 'Initials': 'SE', 'LastName': 'Juul', 'Affiliation': 'Pediatrics-Division of Neonatology, University of Washington, Seattle, WA, USA.'}]",Pediatric research,['10.1038/s41390-019-0298-7'] 105,32247156,Association between delirium prediction scores and days spent with delirium.,"PURPOSE To determine the correlation and discriminative value of the E-PRE-DELIRIC and PRE-DELIRIC scores with delirium exposure to evaluate the prognostic value of both models. METHODS A secondary analysis of a randomized clinical trial enrolling 1506 delirium-free, critically ill adults with an anticipated ICU stay of ≥2 days. Days spent with delirium (≥1 positive CAM-ICU) or coma (≥1 RASS ≤-4) in the 28-days after ICU admission were calculated. Patients were categorized into four groups: no delirium, short-exposure (1 delirium day), moderate-exposure (2-5 delirium days), and long- exposure (≥6 delirium days) to determine the correlation and discriminative value of the E-PRE-DELIRIC and the PRE-DELIRIC with days spent with delirium. RESULTS The correlation between the overall E-PRE-DELIRIC and PRE-DELIRIC scores and days spent with delirium were: R = 0.08 (P = .005) and R = 0.26 (P < .001), respectively. The correlation between both prediction scores and days spent with coma or delirium were R = 0.21 (P < .0001) and R = 0.46 (P < .0001), respectively. The highest Area Under the Receiver Operating Characteristic for both E-PRE-DELIRIC [0.57 (95% CI:0.51-0.62)] and PRE-DELIRIC [0.58 (95% CI:0.53-0.62)] was found in the long delirium exposure group. CONCLUSION The E-PRE-DELIRIC and PRE-DELIRIC model each poorly correlate and discriminate with days spent with delirium in the 28 days after ICU admission.",2020,The correlation between both prediction scores and days spent with coma or delirium were R = 0.21,"['1506 delirium-free, critically ill adults with an anticipated ICU stay of ≥2\xa0days', 'Patients were categorized into four groups: no delirium, short-exposure (1 delirium day), moderate-exposure (2-5 delirium days), and long- exposure (≥6 delirium days) to determine the correlation and discriminative value of the E-PRE-DELIRIC and the PRE-DELIRIC with days spent with delirium']",[],"['overall E-PRE-DELIRIC and PRE-DELIRIC scores', 'prediction scores and days spent with coma or delirium']","[{'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0010101', 'cui_str': 'Correlation Studies'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}]",[],"[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0009421', 'cui_str': 'Coma'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}]",1506.0,0.138306,The correlation between both prediction scores and days spent with coma or delirium were R = 0.21,"[{'ForeName': 'Hidde', 'Initials': 'H', 'LastName': 'Heesakkers', 'Affiliation': 'Department of Intensive Care Medicine, Radboud university medical center, Radboud Institute for Health Sciences, Nijmegen, the Netherlands.'}, {'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'Devlin', 'Affiliation': 'School of Pharmacy, Northeastern University, Boston, MA, USA.'}, {'ForeName': 'Arjen J C', 'Initials': 'AJC', 'LastName': 'Slooter', 'Affiliation': 'Department of Intensive Care Medicine and UMC Utrecht Brain Center, University Medical Center Utrecht, Utrecht University, the Netherlands.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'van den Boogaard', 'Affiliation': 'Department of Intensive Care Medicine, Radboud university medical center, Radboud Institute for Health Sciences, Nijmegen, the Netherlands. Electronic address: Mark.vandenBoogaard@radboudumc.nl.'}]",Journal of critical care,['10.1016/j.jcrc.2020.03.008'] 106,32305093,"Acalabrutinib with or without obinutuzumab versus chlorambucil and obinutuzmab for treatment-naive chronic lymphocytic leukaemia (ELEVATE TN): a randomised, controlled, phase 3 trial.","BACKGROUND Acalabrutinib is a selective, covalent Bruton tyrosine-kinase inhibitor with activity in chronic lymphocytic leukaemia. We compare the efficacy of acalabrutinib with or without obinutuzumab against chlorambucil with obinutuzumab in patients with treatment-naive chronic lymphocytic leukaemia. METHODS ELEVATE TN is a global, phase 3, multicentre, open-label study in patients with treatment-naive chronic lymphocytic leukaemia done at 142 academic and community hospitals in 18 countries. Eligible patients had untreated chronic lymphocytic leukaemia and were aged 65 years or older, or older than 18 years and younger than 65 years with creatinine clearance of 30-69 mL/min (calculated by use of the Cockcroft-Gault equation) or Cumulative Illness Rating Scale for Geriatrics score greater than 6. Additional criteria included an Eastern Cooperative Oncology Group performance status score of 2 or less and adequate haematologic, hepatic, and renal function. Patients with significant cardiovascular disease were excluded, and concomitant treatment with warfarin or equivalent vitamin K antagonists was prohibited. Patients were randomly assigned (1:1:1) centrally via an interactive voice or web response system to receive acalabrutinib and obinutuzumab, acalabrutinib monotherapy, or obinutuzumab and oral chlorambucil. Treatments were administered in 28-day cycles. To reduce infusion-related reactions, acalabrutinib was administered for one cycle before obinutuzumab administration. Oral acalabrutinib was administered (100 mg) twice a day until progressive disease or unacceptable toxic effects occurred. In the acalabrutinib-obinutuzumab group, intravenous obinutuzumab was given on days 1 (100 mg), 2 (900 mg), 8 (1000 mg), and 15 (1000 mg) of cycle 2 and on day 1 (1000 mg) of cycles 3-7. In the obinutuzumab-chlorambucil group, intravenous obinutuzumab was given on days 1 (100 mg), 2 (900 mg), 8 (1000 mg), and 15 (1000 mg) of cycle 1 and on day 1 (1000 mg) of cycles 2-6. Oral chlorambucil was given (0·5 mg/kg) on days 1 and 15 of each cycle, for six cycles. The primary endpoint was progression-free survival between the two combination-therapy groups, assessed by independent review committee. Crossover to acalabrutinib was allowed in patients who progressed on obinutuzumab-chlorambucil. Safety was assessed in all patients who received at least one dose of treatment. Enrolment for this trial is complete, and the study is registered at ClinicalTrials.gov, NCT02475681. FINDINGS Between Sept 14, 2015, and Feb 8, 2017, we recruited 675 patients for assessment. 140 patients did not meet eligibility criteria, and 535 patients were randomly assigned to treatment. 179 patients were assigned to receive acalabrutinib-obinutuzumab, 179 patients were assigned to receive acalabrutinib monotherapy, and 177 patients were assigned to receive obinutuzumab-chlorambucil. At median follow-up of 28·3 months (IQR 25·6-33·1), median progression-free survival was longer with acalabrutinib-obinutuzumab and acalabrutinib monotherapy, compared with obinutuzumab-chlorambucil (median not reached with acalabrutinib and obinutuzumab vs 22·6 months with obinutuzumab, hazard ratio [HR] 0·1; 95% CI 0·06-0·17, p<0·0001; and not reached with acalabrutinib monotherapy vs 22·6 months with obinutuzumab, 0·20; 0·13-0·3, p<0·0001). Estimated progression-free survival at 24 months was 93% with acalabrutinib-obinutuzumab (95% CI 87-96%), 87% with acalabrutinib monotherapy (81-92%), and 47% with obinutuzumab-chlorambucil (39-55%). The most common grade 3 or higher adverse event across groups was neutropenia (53 [30%] of 178 patients in the acalabrutinib-obinutuzumab group, 17 [9%] of 179 patients in the acalabrutinib group, and 70 [41%] of 169 patients in the obinutuzumab-chlorambucil group). All-grade infusion reactions were less frequent with acalabrutinib-obinutuzumab (24 [13%] of 178 patients) than obinutuzumab-chlorambucil (67 [40%] of 169 patients). Grade 3 or higher infections occurred in 37 (21%) patients given acalabrutinib-obinutuzumab, 25 (14%) patients given acalabrutinib monotherapy, and 14 (8%) patients given obinutuzumab-chlorambucil. Deaths occurred in eight (4%) patients given acalabrutinib-obinutuzumab, 12 (7%) patients given acalabrutinib, and 15 (9%) patients given obinutuzumab-chlorambucil. INTERPRETATION Acalabrutinib with or without obinutuzumab significantly improved progression-free survival over obinutuzumab-chlorambucil chemoimmunotherapy, providing a chemotherapy-free treatment option with an acceptable side-effect profile that was consistent with previous studies. These data support the use of acalabrutinib in combination with obinutuzumab or alone as a new treatment option for patients with treatment-naive symptomatic chronic lymphocytic leukaemia. FUNDING Acerta Pharma, a member of the AstraZeneca Group, and R35 CA198183 (to JCB).",2020,All-grade infusion reactions were less frequent with acalabrutinib-obinutuzumab (24 [13%] of 178 patients) than obinutuzumab-chlorambucil (67 [40%] of 169 patients).,"['Eligible patients had untreated chronic lymphocytic leukaemia and were aged 65 years or older, or older than 18 years and younger than 65 years with creatinine clearance of 30-69 mL/min (calculated by use of the Cockcroft-Gault equation) or Cumulative Illness Rating Scale for Geriatrics score greater than 6', '140 patients did not meet eligibility criteria, and 535 patients', '675 patients for assessment', 'patients with treatment-naive chronic lymphocytic leukaemia', 'Between Sept 14, 2015, and Feb 8, 2017', 'Patients with significant cardiovascular disease', 'patients who progressed on obinutuzumab-chlorambucil', ' and 177 patients', '179 patients', 'patients with treatment-naive symptomatic chronic lymphocytic leukaemia', 'treatment-naive chronic lymphocytic leukaemia (ELEVATE TN', 'Additional criteria included an Eastern Cooperative Oncology Group performance status score of 2 or less and adequate haematologic, hepatic, and renal function', 'chronic lymphocytic leukaemia', 'patients with treatment-naive chronic lymphocytic leukaemia done at 142 academic and community hospitals in 18 countries']","['acalabrutinib-obinutuzumab', 'centrally via an interactive voice or web response system to receive acalabrutinib and obinutuzumab, acalabrutinib monotherapy, or obinutuzumab and oral chlorambucil', 'intravenous obinutuzumab', 'acalabrutinib monotherapy', 'Oral chlorambucil', 'warfarin or equivalent vitamin K antagonists', 'acalabrutinib with or without obinutuzumab against chlorambucil with obinutuzumab', 'Acalabrutinib with or without obinutuzumab versus chlorambucil and obinutuzmab', 'obinutuzumab-chlorambucil chemoimmunotherapy', 'obinutuzumab', 'obinutuzumab-chlorambucil']","['Estimated progression-free survival', 'median progression-free survival', 'Deaths', 'Safety', 'Grade 3 or higher infections', 'progression-free survival', 'neutropenia']","[{'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0023434', 'cui_str': 'Chronic lymphocytic leukemia'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0373595', 'cui_str': 'Measurement of renal clearance of creatinine'}, {'cui': 'C0439445', 'cui_str': 'mL/min'}, {'cui': 'C0444686', 'cui_str': 'Calculated'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0017469', 'cui_str': 'Geriatric medicine'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C4517854', 'cui_str': '675'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C2742503', 'cui_str': 'obinutuzumab'}, {'cui': 'C0008163', 'cui_str': 'Chlorambucil'}, {'cui': 'C4517609', 'cui_str': '179'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1520224', 'cui_str': 'ECOG performance status'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0205488', 'cui_str': 'Hematologic'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C0020003', 'cui_str': 'Community hospital'}, {'cui': 'C0454664', 'cui_str': 'Country'}]","[{'cui': 'C4078312', 'cui_str': 'acalabrutinib'}, {'cui': 'C2742503', 'cui_str': 'obinutuzumab'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0008163', 'cui_str': 'Chlorambucil'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0043031', 'cui_str': 'Warfarin'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C1096489', 'cui_str': 'Vitamin K antagonist'}]","[{'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}]",179.0,0.186592,All-grade infusion reactions were less frequent with acalabrutinib-obinutuzumab (24 [13%] of 178 patients) than obinutuzumab-chlorambucil (67 [40%] of 169 patients).,"[{'ForeName': 'Jeff P', 'Initials': 'JP', 'LastName': 'Sharman', 'Affiliation': 'Willamette Valley Cancer Institute/US Oncology, Eugene, OR, USA.'}, {'ForeName': 'Miklos', 'Initials': 'M', 'LastName': 'Egyed', 'Affiliation': 'Department of Hematology, Somogy County Mór Kaposi General Hospital, Kaposvár, Hungary.'}, {'ForeName': 'Wojciech', 'Initials': 'W', 'LastName': 'Jurczak', 'Affiliation': 'Maria Sklodowska-Curie National Institute of Oncology, Kraków, Poland.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Skarbnik', 'Affiliation': 'Department of Medicine, John Theurer Cancer Center, Hackensack University Medical Center, Hackensack, NJ, USA; Lymphoproliferative Disorders Program, Novant Health Cancer Institute, Charlotte NC, USA.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Pagel', 'Affiliation': 'Swedish Cancer Institute, Center for Blood Disorders and Stem Cell Transplantation, Seattle, WA, USA.'}, {'ForeName': 'Ian W', 'Initials': 'IW', 'LastName': 'Flinn', 'Affiliation': 'Sarah Cannon Research Institute, Tennessee Oncology Nashville, Nashville, TN, USA.'}, {'ForeName': 'Manali', 'Initials': 'M', 'LastName': 'Kamdar', 'Affiliation': 'Division of Hematology, Hematologic Malignancies and Stem Cell Transplantation, University of Colorado Cancer Center, Aurora, CO, USA.'}, {'ForeName': 'Talha', 'Initials': 'T', 'LastName': 'Munir', 'Affiliation': ""Haematological Malignancy Diagnostic Service (HMDS), St James's Institute of Oncology, Leeds, UK.""}, {'ForeName': 'Renata', 'Initials': 'R', 'LastName': 'Walewska', 'Affiliation': 'Molecular Pathology, Royal Bournemouth Hospital, Bournemouth, UK.'}, {'ForeName': 'Gillian', 'Initials': 'G', 'LastName': 'Corbett', 'Affiliation': 'Department of Medicine, Tauranga Hospital, Tauranga, New Zealand.'}, {'ForeName': 'Laura Maria', 'Initials': 'LM', 'LastName': 'Fogliatto', 'Affiliation': 'Universidade Federal do Rio Grande do Sul (UFRGS), Porto Alegre, RS, Brazil.'}, {'ForeName': 'Yair', 'Initials': 'Y', 'LastName': 'Herishanu', 'Affiliation': 'Department of Hematology, Tel Aviv Sourasky Medical Center and Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Versha', 'Initials': 'V', 'LastName': 'Banerji', 'Affiliation': 'Departments of Internal Medicine, Biochemistry & Medical Genetics, Max Rady College of Medicine, Rady Faculty of Health Sciences, University of Manitoba, Research Institute in Oncology and Hematology, CancerCare Manitoba, Winnipeg, MB, Canada.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Coutre', 'Affiliation': 'Stanford University School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Follows', 'Affiliation': ""Department of Haematology, Addenbrooke's Hospital NHS Trust, Cambridge, UK.""}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Walker', 'Affiliation': 'Peninsula Health, and Peninsula Private Hospital, Frankston, Victoria, Australia; Alfred Health, Melbourne, Victoria, Australia.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Karlsson', 'Affiliation': 'Department of Haematology, Oncology and Radiophysics, Skåne University Hospital, Lund, Sweden.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Ghia', 'Affiliation': 'Università Vita-Salute San Raffaele and IRCCS Ospedale San Raffaele, Milano, Italy.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Janssens', 'Affiliation': 'Hematology Department, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'Florence', 'Initials': 'F', 'LastName': 'Cymbalista', 'Affiliation': 'Bobigny: Hématologie, CHU Avicennes, Bobigny, France.'}, {'ForeName': 'Jennifer A', 'Initials': 'JA', 'LastName': 'Woyach', 'Affiliation': 'The Ohio State University Comprehensive Cancer Center and Division of Hematology, Columbus, OH, USA.'}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Salles', 'Affiliation': ""Hospices Civils de Lyon, Centre Hospitalier Lyon Sud, Service d'Hématologie Clinique, Pierre-Bénite, France.""}, {'ForeName': 'William G', 'Initials': 'WG', 'LastName': 'Wierda', 'Affiliation': 'Department of Leukemia, The University of Texas M D Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Raquel', 'Initials': 'R', 'LastName': 'Izumi', 'Affiliation': 'Acerta Pharma, a member of the AstraZeneca Group, South San Francisco, CA, USA.'}, {'ForeName': 'Veerendra', 'Initials': 'V', 'LastName': 'Munugalavadla', 'Affiliation': 'Acerta Pharma, a member of the AstraZeneca Group, South San Francisco, CA, USA.'}, {'ForeName': 'Priti', 'Initials': 'P', 'LastName': 'Patel', 'Affiliation': 'Acerta Pharma, a member of the AstraZeneca Group, South San Francisco, CA, USA.'}, {'ForeName': 'Min Hui', 'Initials': 'MH', 'LastName': 'Wang', 'Affiliation': 'Acerta Pharma, a member of the AstraZeneca Group, South San Francisco, CA, USA.'}, {'ForeName': 'Sofia', 'Initials': 'S', 'LastName': 'Wong', 'Affiliation': 'Acerta Pharma, a member of the AstraZeneca Group, South San Francisco, CA, USA.'}, {'ForeName': 'John C', 'Initials': 'JC', 'LastName': 'Byrd', 'Affiliation': 'The Ohio State University Comprehensive Cancer Center and Division of Hematology, Columbus, OH, USA. Electronic address: john.byrd@osumc.edu.'}]","Lancet (London, England)",['10.1016/S0140-6736(20)30262-2'] 107,32321516,Virtual reality distraction induces hypoalgesia in patients with chronic low back pain: a randomized controlled trial.,"BACKGROUND Attentional distraction from pain has been shown to be largely ineffective for obtaining a hypoalgesic effect in patients with chronic pain when compared to a control condition. It has been hypothesized that this may be due to the non-engaging types of distraction that have been used so far. Moreover, it is suggested that the hypoalgesic effects of distraction may be attenuated by pain-related cognitions and emotions, as they may increase the attention to pain. METHODS In this randomized controlled trial, patients with chronic nonspecific low back pain in the intervention group (n = 42) performed a single exercise session with nonimmersive VR games, while those in the control group (n = 42) performed the same exercises without VR games. We investigated whether VR distraction had a hypoalgesic effect during and immediately after the exercises, and whether it reduced the time spent thinking of pain during the exercises. We further explored whether pain-related fear, pain catastrophizing and baseline pain intensity moderated the effects of VR distraction. RESULTS VR distraction had a hypoalgesic effect during (Cohen's d = 1.29) and immediately after (Cohen's d = 0.85) the exercises, and it also reduced the time spent thinking of pain (Cohen's d = 1.31). Preliminary exploratory analyses showed that pain-related fear, pain catastrophizing and baseline pain intensity did not moderate the effects of VR distraction. CONCLUSIONS Large effect sizes of VR distraction induced hypoalgesia were observed. This suggests that nonimmersive VR games can be used when it is deemed important to reduce the pain during exercises in patients with chronic nonspecific low back pain. TRIAL REGISTRATION NCT02679300. This trial was registered on 10 February 2016.",2020,"RESULTS VR distraction had a hypoalgesic effect during (Cohen's d = 1.29) and immediately after (Cohen's d = 0.85) the exercises, and it also reduced the time spent thinking of pain (Cohen's d = 1.31).","['patients with chronic pain', 'patients with chronic nonspecific low back pain in the intervention group (n\u2009=\u200942', 'patients with chronic low back pain', 'patients with chronic nonspecific low back pain', '10 February 2016']","['single exercise session with nonimmersive VR games, while those in the control group (n\u2009=\u200942) performed the same exercises without VR games', 'VR distraction', 'Virtual reality distraction']","['hypoalgesic effect', 'time spent thinking of pain', 'pain-related fear, pain catastrophizing and baseline pain intensity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0150189', 'cui_str': 'Distraction training'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}]","[{'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C3178745', 'cui_str': 'Pain Catastrophizing'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}]",,0.078121,"RESULTS VR distraction had a hypoalgesic effect during (Cohen's d = 1.29) and immediately after (Cohen's d = 0.85) the exercises, and it also reduced the time spent thinking of pain (Cohen's d = 1.31).","[{'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Matheve', 'Affiliation': 'Faculty of Rehabilitation Sciences, Hasselt University, Agoralaan, building A, 3590, Diepenbeek, Belgium. Thomas.Matheve@uhasselt.be.'}, {'ForeName': 'Katleen', 'Initials': 'K', 'LastName': 'Bogaerts', 'Affiliation': 'Faculty of Rehabilitation Sciences, Hasselt University, Agoralaan, building A, 3590, Diepenbeek, Belgium.'}, {'ForeName': 'Annick', 'Initials': 'A', 'LastName': 'Timmermans', 'Affiliation': 'Faculty of Rehabilitation Sciences, Hasselt University, Agoralaan, building A, 3590, Diepenbeek, Belgium.'}]",Journal of neuroengineering and rehabilitation,['10.1186/s12984-020-00688-0'] 108,32259695,"Initial evidence for pharmacological modulation of observational threat learning by the GABAergic, but not the noradrenergic system in humans.","Threat responses are often shaped by social information, such as observation of aversive outcomes for others. Yet, the neurochemistry regulating observational learning of threats is largely unknown. Here, we examined the impact of the GABAergic and noradrenergic system, which are central in regulating threat learning from first-hand experiences, on observational threat learning in humans. To this end, 61 participants received either 1 mg Lorazepam (enhancing GABAergic signalling N = 18), 20 mg Yohimbine (enhancing Noradrenergic transmission, N = 16), Placebo (double blind and randomized control for Lorazepam and Yohimbine, N = 12) or no treatment (N = 15) prior to observational threat conditioning. Participants acquired conditioned threat responses by observation of another individual who is presented with a conditioned stimulus (CS) and an aversive unconditioned stimulus (US). Participants' threat responses were tested by direct exposure to the CSs immediately after learning, as well as two days later (drug free). Our results indicate decreased fear ratings to socially acquired CSs by enhanced GABAergic transmission as compared to the control group (placebo and no treatment) during the immediate test. We could not provide evidence for noradrenergic modulation of socially acquired threat responses. Further, we found no differences in psychophysiological responses (Skin conductance responses) or long-term persistence of conditioned responses. Our results provide initial evidence for an impact of the GABAergic system on social acquisition of threats.",2020,"Further, we found no differences in psychophysiological responses (Skin conductance responses) or long-term persistence of conditioned responses.","['61 participants received either', 'humans']","['1\xa0mg Lorazepam', 'Yohimbine (enhancing Noradrenergic transmission, N\xa0=\xa016), Placebo (double blind and randomized control for Lorazepam and Yohimbine, N\xa0=\xa012) or no treatment (N\xa0=\xa015) prior to observational threat conditioning']","['psychophysiological responses (Skin conductance responses) or long-term persistence of conditioned responses', 'fear ratings']","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}]","[{'cui': 'C0024002', 'cui_str': 'Lorazepam'}, {'cui': 'C0724441', 'cui_str': 'yohimbine'}, {'cui': 'C0040722', 'cui_str': 'transmission'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C1518527', 'cui_str': 'Observational Study'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0546816', 'cui_str': 'Persistence'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0015726', 'cui_str': 'Fear'}]",,0.0495426,"Further, we found no differences in psychophysiological responses (Skin conductance responses) or long-term persistence of conditioned responses.","[{'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Esser', 'Affiliation': 'Department of Systems Neuroscience, University Medical Center Hamburg-Eppendorf, Germany.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Fuss', 'Affiliation': 'Department of Systems Neuroscience, University Medical Center Hamburg-Eppendorf, Germany; Institute for Sex Research, Sexual Medicine and Forensic Psychiatry, Center of Psychosocial Medicine, University Medical Center Hamburg-Eppendorf, Germany.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Haaker', 'Affiliation': 'Department of Systems Neuroscience, University Medical Center Hamburg-Eppendorf, Germany. Electronic address: j.haaker@uke.de.'}]",Behaviour research and therapy,['10.1016/j.brat.2020.103605'] 109,30702365,Peer Navigator Intervention for Latinos on Hemodialysis: A Single-Arm Clinical Trial.,"Background: Latinos with end-stage renal disease (ESRD) have worse mental and kidney composite health-related quality of life (HRQOL) scores compared to non-Latino ESRD patients. Latino ESRD patients uniquely report that social factors (e.g., lack of care coordination, food insecurity, and low health literacy) and mental health influence their HRQOL. We developed a culturally tailored peer navigator (PN) intervention to improve the HRQOL of Latinos on hemodialysis. Objective: To determine the feasibility of the PN intervention. Design: Single-arm prospective study. The PN provided individualized support with advance care planning, care coordination, and counseling about the importance of diet and mental health. Setting and Participants: Latino with ESRD receiving scheduled outpatient thrice-weekly hemodialysis or reliant on emergency-only hemodialysis in Denver. Main measures: Recruitment, retention rates, data completeness, intervention dose, patient- and staff-reported satisfaction with the intervention. Results: Of 49 eligible patients, 40 (82%) agreed to participate. The majority of participants received scheduled outpatient hemodialysis (75%), 20 were women (50%), with a mean (standard deviation [SD]) age of 56 (13) years. No participants withdrew from the intervention. One participant died. The mean (SD) number of PN visits per participant was 7 (2) and the mean (SD) length of the visits was 97 minutes (49). The majority of visits took place at the hemodialysis facility (59%) and home (27%). The vast majority of participants reported that the PN improved their quality of life as a patient on hemodialysis (95%). Conclusions: The PN intervention achieved feasibility goals and was well received by participants.",2019,(ESRD) have worse mental and kidney composite health-related quality of life (HRQOL) scores compared to non-Latino ESRD patients.,"['Latino with ESRD receiving scheduled outpatient thrice-weekly hemodialysis or reliant on emergency-only hemodialysis in Denver', 'Latinos on Hemodialysis', 'Latino ESRD patients', 'participants received scheduled outpatient hemodialysis (75%), 20 were women (50%), with a mean (standard deviation [SD]) age of 56 (13) years', ': Latinos with end-stage renal disease', '49 eligible patients, 40 (82%) agreed to participate']","['culturally tailored peer navigator (PN) intervention', 'Peer Navigator Intervention']","['Main measures: Recruitment, retention rates, data completeness, intervention dose, patient- and staff-reported satisfaction with the intervention', 'feasibility goals', 'quality of life', 'mean (SD) number of PN visits', 'mental and kidney composite health-related quality of life (HRQOL) scores']","[{'cui': 'C0086528', 'cui_str': 'Latinos'}, {'cui': 'C0022661', 'cui_str': 'End-Stage Kidney Disease'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0556987', 'cui_str': 'Three times weekly (qualifier value)'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0175673', 'cui_str': 'Emergency (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]",[],"[{'cui': 'C0205225', 'cui_str': 'Principal (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0439812', 'cui_str': 'Completeness (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2700616', 'cui_str': 'Manpowers'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0018017', 'cui_str': 'Goals'}, {'cui': 'C0034380'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0022646', 'cui_str': 'Kidney'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",20.0,0.0380135,(ESRD) have worse mental and kidney composite health-related quality of life (HRQOL) scores compared to non-Latino ESRD patients.,"[{'ForeName': 'Lilia', 'Initials': 'L', 'LastName': 'Cervantes', 'Affiliation': '1 Department of Medicine, Denver Health, Denver, Colorado.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Chonchol', 'Affiliation': '2 Department of General Internal Medicine, University of Colorado School of Medicine, Aurora, Colorado.'}, {'ForeName': 'Romana', 'Initials': 'R', 'LastName': 'Hasnain-Wynia', 'Affiliation': '3 Office of Research, Denver Health, Denver, Colorado.'}, {'ForeName': 'John F', 'Initials': 'JF', 'LastName': 'Steiner', 'Affiliation': '4 Institute for Health Research, Kaiser Permanente Colorado, Denver, Colorado.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Havranek', 'Affiliation': '1 Department of Medicine, Denver Health, Denver, Colorado.'}, {'ForeName': 'Madelyne', 'Initials': 'M', 'LastName': 'Hull', 'Affiliation': '1 Department of Medicine, Denver Health, Denver, Colorado.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Rice', 'Affiliation': '5 Colorado School of Public Health, University of Colorado, Denver, Colorado.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Kendrick', 'Affiliation': '2 Department of General Internal Medicine, University of Colorado School of Medicine, Aurora, Colorado.'}, {'ForeName': 'Xochilt', 'Initials': 'X', 'LastName': 'Alamillo', 'Affiliation': '6 Aurora Mental Health Center, Aurora, Colorado.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Camacho', 'Affiliation': '1 Department of Medicine, Denver Health, Denver, Colorado.'}, {'ForeName': 'Stacy', 'Initials': 'S', 'LastName': 'Fischer', 'Affiliation': '7 Division of General Internal Medicine, University of Colorado School of Medicine, Aurora, Colorado.'}]",Journal of palliative medicine,['10.1089/jpm.2018.0439'] 110,32338756,Dietary Intake and Biomarkers of Folate and Cobalamin Status in Norwegian Preschool Children: The FINS-KIDS Study.,"BACKGROUND Folate and cobalamin (vitamin B-12) are essential for growth and development. However, few population-based studies have investigated B-vitamin status in children. OBJECTIVES This study aimed to assess biomarkers of folate and vitamin B-12 status and to explore their dietary determinants in healthy Norwegian children. METHODS Using baseline data obtained from a randomized controlled trial on the effect of fish intake on neurodevelopment in children aged 4-6 y, we measured the plasma concentrations of folate, cobalamin, total plasma homocysteine (tHcy), and methylmalonic acid (MMA). Food-frequency questionnaires (FFQs) were used to assess dietary intake. We used unadjusted and multiple linear regression models to explore the determinants of biomarker concentrations. RESULTS The median (IQR) of plasma folate (n = 197) and plasma cobalamin (n = 195) concentrations were 15.2 (12.2-21.1) nmol/L and 785 (632-905) pmol/L, respectively. Plasma folate concentrations of <10 nmol/L were observed in 13% of the children. No child had a cobalamin concentration <148 pmol/L. Two children were identified with elevated plasma MMA concentrations (>0.26 μmol/L) and 8 children had elevated tHcy concentrations (>6.5 μmol/L). Plasma folate concentration was inversely correlated with tHcy (ρ = -0.24, P < 0.001); we found no correlation between tHcy and cobalamin (ρ = -0.075, P = 0.30). Children who consumed vitamin supplements had 51% higher plasma folate concentrations (P < 0.0001) than those who did not. Consumption of red meat for dinner more than twice a week was associated with 23% lower plasma folate (P < 0.01). No other significant associations between dietary intake and the biomarkers were observed. CONCLUSIONS The Norwegian preschool children from this cohort had adequate vitamin B-12 status. Poor folate status was common and associated with elevated tHcy. The implications of poor folate status during childhood should be a prioritized research question. This trial was registered at ClinicalTrials.gov as NCT02331667.",2020,Children who consumed vitamin supplements had 51% higher plasma folate concentrations (P < 0.0001) than those who did not.,"['Norwegian preschool children', 'healthy Norwegian children', 'Norwegian Preschool Children', 'children aged 4-6 y']","['vitamin supplements', 'Folate and cobalamin (vitamin B-12']","['Plasma folate concentrations', 'Consumption of red meat', 'plasma folate concentrations', 'Plasma folate concentration', 'Poor folate status', 'Food-frequency questionnaires (FFQs', 'median (IQR) of plasma folate', 'plasma folate', 'Dietary Intake and Biomarkers of Folate and Cobalamin Status', 'cobalamin concentration', 'elevated tHcy concentrations', 'elevated plasma MMA concentrations', 'plasma concentrations of folate, cobalamin, total plasma homocysteine (tHcy), and methylmalonic acid (MMA']","[{'cui': 'C0028424', 'cui_str': 'Norwegian language'}, {'cui': 'C0008100', 'cui_str': 'Preschool child'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0301532', 'cui_str': 'Multivitamin preparation'}, {'cui': 'C0178638', 'cui_str': 'Folate'}, {'cui': 'C0042845', 'cui_str': 'Vitamin B 12'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0178638', 'cui_str': 'Folate'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0452848', 'cui_str': 'Red meat'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0042845', 'cui_str': 'Vitamin B 12'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0019878', 'cui_str': 'Homocysteine'}, {'cui': 'C0025787', 'cui_str': 'Methyl malonic acid'}]",2.0,0.0824589,Children who consumed vitamin supplements had 51% higher plasma folate concentrations (P < 0.0001) than those who did not.,"[{'ForeName': 'Beate S', 'Initials': 'BS', 'LastName': 'Solvik', 'Affiliation': 'Innlandet Hospital Trust, Lillehammer, Norway.'}, {'ForeName': 'Tor A', 'Initials': 'TA', 'LastName': 'Strand', 'Affiliation': 'Innlandet Hospital Trust, Lillehammer, Norway.'}, {'ForeName': 'Ingrid', 'Initials': 'I', 'LastName': 'Kvestad', 'Affiliation': 'Regional Center for Child and Youth Mental Health and Child Welfare, NORCE Norwegian Research Center, Bergen, Norway.'}, {'ForeName': 'Maria W', 'Initials': 'MW', 'LastName': 'Markhus', 'Affiliation': 'Institute of Marine Research, Bergen, Norway.'}, {'ForeName': 'Per M', 'Initials': 'PM', 'LastName': 'Ueland', 'Affiliation': 'Bevital AS, Bergen, Norway.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'McCann', 'Affiliation': 'Bevital AS, Bergen, Norway.'}, {'ForeName': 'Jannike', 'Initials': 'J', 'LastName': 'Øyen', 'Affiliation': 'Institute of Marine Research, Bergen, Norway.'}]",The Journal of nutrition,['10.1093/jn/nxaa111'] 111,32187464,A Trial of Lopinavir-Ritonavir in Adults Hospitalized with Severe Covid-19.,"BACKGROUND No therapeutics have yet been proven effective for the treatment of severe illness caused by SARS-CoV-2. METHODS We conducted a randomized, controlled, open-label trial involving hospitalized adult patients with confirmed SARS-CoV-2 infection, which causes the respiratory illness Covid-19, and an oxygen saturation (Sao 2 ) of 94% or less while they were breathing ambient air or a ratio of the partial pressure of oxygen (Pao 2 ) to the fraction of inspired oxygen (Fio 2 ) of less than 300 mm Hg. Patients were randomly assigned in a 1:1 ratio to receive either lopinavir-ritonavir (400 mg and 100 mg, respectively) twice a day for 14 days, in addition to standard care, or standard care alone. The primary end point was the time to clinical improvement, defined as the time from randomization to either an improvement of two points on a seven-category ordinal scale or discharge from the hospital, whichever came first. RESULTS A total of 199 patients with laboratory-confirmed SARS-CoV-2 infection underwent randomization; 99 were assigned to the lopinavir-ritonavir group, and 100 to the standard-care group. Treatment with lopinavir-ritonavir was not associated with a difference from standard care in the time to clinical improvement (hazard ratio for clinical improvement, 1.31; 95% confidence interval [CI], 0.95 to 1.80). Mortality at 28 days was similar in the lopinavir-ritonavir group and the standard-care group (19.2% vs. 25.0%; difference, -5.8 percentage points; 95% CI, -17.3 to 5.7). The percentages of patients with detectable viral RNA at various time points were similar. In a modified intention-to-treat analysis, lopinavir-ritonavir led to a median time to clinical improvement that was shorter by 1 day than that observed with standard care (hazard ratio, 1.39; 95% CI, 1.00 to 1.91). Gastrointestinal adverse events were more common in the lopinavir-ritonavir group, but serious adverse events were more common in the standard-care group. Lopinavir-ritonavir treatment was stopped early in 13 patients (13.8%) because of adverse events. CONCLUSIONS In hospitalized adult patients with severe Covid-19, no benefit was observed with lopinavir-ritonavir treatment beyond standard care. Future trials in patients with severe illness may help to confirm or exclude the possibility of a treatment benefit. (Funded by Major Projects of National Science and Technology on New Drug Creation and Development and others; Chinese Clinical Trial Register number, ChiCTR2000029308.).",2020,"Treatment with lopinavir-ritonavir was not associated with a difference from standard care in the time to clinical improvement (hazard ratio for clinical improvement, 1.24; 95% confidence interval [CI], 0.90 to 1.72).","['Adults Hospitalized with Severe Covid-19', 'hospitalized adult patients with confirmed SARS-CoV-2 infection, which causes the respiratory illness Covid-19, and an oxygen saturation (Sao 2 ) of 94% or less while they were breathing ambient air or a ratio of the partial pressure of oxygen (Pao 2 ) to the fraction of inspired oxygen (Fio 2 ) of less than 300 mm Hg', '199 patients with laboratory-confirmed SARS-CoV-2 infection underwent randomization; 99 were assigned to the', 'patients with severe illness']","['lopinavir-ritonavir', 'Lopinavir-ritonavir', 'Lopinavir-Ritonavir']","['Gastrointestinal adverse events', 'serious adverse events', 'time to clinical improvement, defined as the time from randomization to either an improvement of two points on a seven-category ordinal scale or discharge from the hospital, whichever came first', 'Mortality']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'TS-COV19'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0221423', 'cui_str': 'Illness (finding)'}, {'cui': 'C0523807', 'cui_str': 'Oximetry'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0030604', 'cui_str': 'Partial Pressure'}, {'cui': 'C0232555', 'cui_str': 'Peak gastric acid output (observable entity)'}, {'cui': 'C0428167', 'cui_str': 'FIO2'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}]","[{'cui': 'C0674432', 'cui_str': 'lopinavir'}, {'cui': 'C0292818', 'cui_str': 'Ritonavir'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0222045'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0960273', 'cui_str': 'CAME'}, {'cui': 'C0026566', 'cui_str': 'mortality'}]",199.0,0.162561,"Treatment with lopinavir-ritonavir was not associated with a difference from standard care in the time to clinical improvement (hazard ratio for clinical improvement, 1.24; 95% confidence interval [CI], 0.90 to 1.72).","[{'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Cao', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Yeming', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Danning', 'Initials': 'D', 'LastName': 'Wen', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Liu', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Jingli', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Guohui', 'Initials': 'G', 'LastName': 'Fan', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Lianguo', 'Initials': 'L', 'LastName': 'Ruan', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Song', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Yanping', 'Initials': 'Y', 'LastName': 'Cai', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Wei', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Xingwang', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Jiaan', 'Initials': 'J', 'LastName': 'Xia', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Nanshan', 'Initials': 'N', 'LastName': 'Chen', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Xiang', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Yu', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Bai', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Xuelei', 'Initials': 'X', 'LastName': 'Xie', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Caihong', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Ye', 'Initials': 'Y', 'LastName': 'Yuan', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Huadong', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Hanping', 'Initials': 'H', 'LastName': 'Huang', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Shengjing', 'Initials': 'S', 'LastName': 'Tu', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Fengyun', 'Initials': 'F', 'LastName': 'Gong', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Wei', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Chongya', 'Initials': 'C', 'LastName': 'Dong', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Zhou', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Xiaoying', 'Initials': 'X', 'LastName': 'Gu', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Jiuyang', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Zhibo', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Lianhan', 'Initials': 'L', 'LastName': 'Shang', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Ke', 'Initials': 'K', 'LastName': 'Wang', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Kunxia', 'Initials': 'K', 'LastName': 'Li', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Zhou', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Xuan', 'Initials': 'X', 'LastName': 'Dong', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Zhaohui', 'Initials': 'Z', 'LastName': 'Qu', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Sixia', 'Initials': 'S', 'LastName': 'Lu', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Xujuan', 'Initials': 'X', 'LastName': 'Hu', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Shunan', 'Initials': 'S', 'LastName': 'Ruan', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Shanshan', 'Initials': 'S', 'LastName': 'Luo', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Peng', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Cheng', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Lihong', 'Initials': 'L', 'LastName': 'Pan', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Zou', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Chunmin', 'Initials': 'C', 'LastName': 'Jia', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Shuzhen', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Xudong', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Qin', 'Initials': 'Q', 'LastName': 'Ge', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'He', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Haiyan', 'Initials': 'H', 'LastName': 'Zhan', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Qiu', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Guo', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Chaolin', 'Initials': 'C', 'LastName': 'Huang', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Jaki', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Frederick G', 'Initials': 'FG', 'LastName': 'Hayden', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Peter W', 'Initials': 'PW', 'LastName': 'Horby', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Dingyu', 'Initials': 'D', 'LastName': 'Zhang', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'From the Department of Pulmonary and Critical Care Medicine, Center of Respiratory Medicine, National Clinical Research Center for Respiratory Diseases (B.C., Yeming Wang, G.F., F.Z., X.G., Z.L., Y.Z., Hui Li, L.S., C.W.), and the Institute of Clinical Medical Sciences (G.F., X.G.), China-Japan Friendship Hospital, the Institute of Respiratory Medicine, Chinese Academy of Medical Sciences (B.C., Yeming Wang, F.Z., Z.L., Y.Z., Hui Li, C.W.), the Clinical and Research Center of Infectious Diseases, Beijing Ditan Hospital, Capital Medical University (Xingwang Li), Peking University Clinical Research Institute, Peking University First Hospital (C.D.), Tsinghua University School of Medicine (Jiuyang Xu), Beijing University of Chinese Medicine (L.S.), NHC Key Laboratory of Systems Biology of Pathogens and Christophe Merieux Laboratory, Institute of Pathogen Biology, Chinese Academy of Medical Sciences (L.G.), and Peking Union Medical College (L.G., C.W.), Beijing, and Jin Yin-tan Hospital, Wuhan (D.W., W.L., Jingli Wang, L.R., B.S., Y.C., M.W., Jiaan Xia, N.C., Jie Xiang, T.Y., T.B., X.X., L.Z., C.L., Y.Y., H.C., Huadong Li, H.H., S.T., F.G., Y.L., Yuan Wei, K.W., K.L., X.Z., X.D., Z.Q., Sixia Lu, X.H., S.R., Shanshan Luo, Jing Wu, Lu Peng, F.C., Lihong Pan, J.Z., C.J., Juan Wang, Xia Liu, S.W., X.W., Q.G., J.H., H.Z., F.Q., C.H., D.Z.) - all in China; Lancaster University, Lancaster (T.J.), and the University of Oxford, Oxford (P.W.H.) - both in the United Kingdom; and the University of Virginia School of Medicine, Charlottesville (F.G.H.).'}]",The New England journal of medicine,['10.1056/NEJMoa2001282'] 112,31738014,"Transcutaneous Electrical Nerve Stimulation Reduces Movement-Evoked Pain and Fatigue: A Randomized, Controlled Trial.","OBJECTIVE Fibromyalgia (FM) is characterized by pain and fatigue, particularly during physical activity. Transcutaneous electrical nerve stimulation (TENS) activates endogenous pain inhibitory mechanisms. This study was undertaken to investigate if using TENS during activity would improve movement-evoked pain and other patient-reported outcomes in women with FM. METHODS Participants were randomly assigned to receive active TENS (n = 103), placebo TENS (n = 99), or no TENS (n = 99) and instructed to use it at home during activity 2 hours each day for 4 weeks. TENS was applied to the lumbar and cervicothoracic regions using a modulated frequency (2-125 Hz) at the highest tolerable intensity. Participants rated movement-evoked pain (primary outcome measure) and fatigue on an 11-point scale before and during application of TENS. The primary outcome measure and secondary patient-reported outcomes were assessed at baseline (time of randomization) and at 4 weeks. RESULTS After 4 weeks, a greater reduction in movement-evoked pain was reported in the active TENS group versus the placebo TENS group (group mean difference -1.0 [95% confidence interval -1.8, -0.2]; P = 0.008) and versus the no TENS group (group mean difference -1.8 [95% confidence interval -2.6, -1.0]; P < 0.0001). A reduction in movement-evoked fatigue was also reported in the active TENS group versus the placebo TENS group (group mean difference -1.4 [95% confidence interval -2.4, -0.4]; P = 0.001) and versus the no TENS group (group mean difference -1.9 [95% confidence interval -2.9, -0.9]; P = <0.0001). A greater percentage of the patients in the active TENS group reported improvement on the global impression of change compared to the placebo TENS group (70% versus 31%; P < 0.0001) and the no TENS group (9%; P < 0.0001). There were no TENS-related serious adverse events, and <5% of participants experienced minor adverse events from TENS. CONCLUSION Among women who had FM and were on a stable medication regimen, 4 weeks of active TENS use compared to placebo TENS or no TENS resulted in a significant improvement in movement-evoked pain and other clinical outcomes. Further research is needed to examine effectiveness in a real-world setting to establish the clinical importance of these findings.",2020,"A greater percentage of the active-TENS group reported improvement on the global impression of change when compared to placebo-TENS (70% vs. 31%, p<0.0001) and no-TENS (9%, p<0.0001).","['women with FM', 'Women with Fibromyalgia', 'Participants']","['Transcutaneous electrical nerve stimulation (TENS', 'active-TENS', 'placebo-TENS or no-TENS', 'placebo-TENS (n=99) or no-TENS', 'TENS']","['movement-evoked pain and fatigue', 'movement-evoked pain', 'global impression of change', 'movement-evoked pain (primary outcome) and fatigue on an 11-point scale']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0016053', 'cui_str': 'Fibrositis'}]","[{'cui': 'C0040654', 'cui_str': 'Electric Stimulation, Transcutaneous'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0014518', 'cui_str': ""Lyell's Syndrome""}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C1444748', 'cui_str': 'Provoked by (attribute)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0222045'}]",,0.528626,"A greater percentage of the active-TENS group reported improvement on the global impression of change when compared to placebo-TENS (70% vs. 31%, p<0.0001) and no-TENS (9%, p<0.0001).","[{'ForeName': 'Dana L', 'Initials': 'DL', 'LastName': 'Dailey', 'Affiliation': 'University of Iowa, Iowa City, and St. Ambrose University, Davenport, Iowa.'}, {'ForeName': 'Carol G T', 'Initials': 'CGT', 'LastName': 'Vance', 'Affiliation': 'University of Iowa, Iowa City.'}, {'ForeName': 'Barbara A', 'Initials': 'BA', 'LastName': 'Rakel', 'Affiliation': 'University of Iowa, Iowa City.'}, {'ForeName': 'M Bridget', 'Initials': 'MB', 'LastName': 'Zimmerman', 'Affiliation': 'University of Iowa, Iowa City.'}, {'ForeName': 'Jennie', 'Initials': 'J', 'LastName': 'Embree', 'Affiliation': 'University of Iowa, Iowa City.'}, {'ForeName': 'Ericka N', 'Initials': 'EN', 'LastName': 'Merriwether', 'Affiliation': 'New York University, New York, New York.'}, {'ForeName': 'Katharine M', 'Initials': 'KM', 'LastName': 'Geasland', 'Affiliation': 'University of Iowa, Iowa City.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Chimenti', 'Affiliation': 'University of Iowa, Iowa City.'}, {'ForeName': 'Jon M', 'Initials': 'JM', 'LastName': 'Williams', 'Affiliation': 'Vanderbilt University, Nashville, Tennessee.'}, {'ForeName': 'Meenakshi', 'Initials': 'M', 'LastName': 'Golchha', 'Affiliation': 'Vanderbilt University, Nashville, Tennessee.'}, {'ForeName': 'Leslie J', 'Initials': 'LJ', 'LastName': 'Crofford', 'Affiliation': 'Vanderbilt University, Nashville, Tennessee.'}, {'ForeName': 'Kathleen A', 'Initials': 'KA', 'LastName': 'Sluka', 'Affiliation': 'University of Iowa, Iowa City.'}]","Arthritis & rheumatology (Hoboken, N.J.)",['10.1002/art.41170'] 113,31761974,Predictors of duloxetine response in patients with neuropathic cancer pain: a secondary analysis of a randomized controlled trial-JORTC-PAL08 (DIRECT) study.,"PURPOSE Duloxetine has some effect against cancer neuropathic pain (CNP); however, predictors of duloxetine response are unclear. This study sought to identify predictors of duloxetine response in patients with CNP. METHODS Patients (N = 70) with CNP unresponsive to or intolerant of opioid-pregabalin combination therapy, with a brief pain inventory-short form (BPI-SF) Item 5 score (average pain) ≥ 4, and with a total hospital anxiety and depression scale score < 20, were randomized to a duloxetine or a placebo group. Multiple linear regression analysis was conducted to identify predictors of duloxetine response as a secondary analysis with the change in the average pain score on day 10 from day 0 as the dependent variable, and the following five covariates; baseline (day 0) average pain score, baseline opioid dose, continuation/discontinuation of pregabalin, and items 20 and 21 score of the short-form McGill pain questionnaire 2 (SF-MPQ-2) as independent variables. RESULTS Of the four domains (continuous pain, intermittent pain, neuropathic pain, and affective descriptors) score of SF-MPQ-2 on day 0, significant differences were observed in the neuropathic pain domain (p = 0.040) in change on the average pain between day 10 and day 0 in the duloxetine group. Multiple linear regression analysis revealed that patients with a high score for SF-MPQ-2 Item 21 (tingling pain) on day 0 had a significantly greater change in average pain between day 10 and day 0 (p = 0.046). CONCLUSION Patients with a high score for SF-MPQ-2 Item 21 might benefit more from duloxetine.",2020,"Multiple linear regression analysis revealed that patients with a high score for SF-MPQ-2 Item 21 (tingling pain) on day 0 had a significantly greater change in average pain between day 10 and day 0 (p = 0.046). ","['Patients (N = 70) with CNP unresponsive to or intolerant of opioid-pregabalin combination therapy, with a brief pain inventory-short form', 'patients with CNP', 'patients with neuropathic cancer pain', '≥ 4, and with a total hospital anxiety and depression scale score < 20']","['Duloxetine', 'duloxetine', 'placebo']","['pain score, baseline opioid dose, continuation/discontinuation of pregabalin, and items 20 and 21 score of the short-form McGill pain questionnaire 2 (SF-MPQ-2', 'neuropathic pain domain', 'average pain score', 'pain, intermittent pain, neuropathic pain, and affective descriptors) score of SF-MPQ-2', 'average pain', 'BPI-SF) Item 5 score (average pain']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0237284', 'cui_str': 'Unresponsive'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0657912', 'cui_str': 'pregabalin'}, {'cui': 'C0556895', 'cui_str': 'Combination therapy (regime/therapy)'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0596240', 'cui_str': 'Tumor-Related Pain'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0451221', 'cui_str': 'Hospital anxiety and depression scale (assessment scale)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]","[{'cui': 'C0245561', 'cui_str': 'duloxetine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0657912', 'cui_str': 'pregabalin'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0457972', 'cui_str': 'Short form McGill pain questionnaire (assessment scale)'}, {'cui': 'C0027796', 'cui_str': 'Neurodynia'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1282310', 'cui_str': 'Intermittent pain'}, {'cui': 'C0282354', 'cui_str': 'Descriptors'}]",21.0,0.201097,"Multiple linear regression analysis revealed that patients with a high score for SF-MPQ-2 Item 21 (tingling pain) on day 0 had a significantly greater change in average pain between day 10 and day 0 (p = 0.046). ","[{'ForeName': 'Hiromichi', 'Initials': 'H', 'LastName': 'Matsuoka', 'Affiliation': 'Department of Psychosomatic Medicine, Kindai University Faculty of Medicine, Osaka, Japan. matsuoka_h@med.kindai.ac.jp.'}, {'ForeName': 'Satoru', 'Initials': 'S', 'LastName': 'Iwase', 'Affiliation': 'Department of Palliative Medicine, University of Saitama Medical University, Saitama, Japan.'}, {'ForeName': 'Tempei', 'Initials': 'T', 'LastName': 'Miyaji', 'Affiliation': 'Department of Clinical Trial Data Management, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Kawaguchi', 'Affiliation': 'Department of Practical Pharmacy, Tokyo University of Pharmacy and Life Sciences, Tokyo, Japan.'}, {'ForeName': 'Keisuke', 'Initials': 'K', 'LastName': 'Ariyoshi', 'Affiliation': 'Japanese Organization for Research and Treatment of Cancer (JORTC), JORTC Data Center, Tokyo, Japan.'}, {'ForeName': 'Shunsuke', 'Initials': 'S', 'LastName': 'Oyamada', 'Affiliation': 'Japanese Organization for Research and Treatment of Cancer (JORTC), JORTC Data Center, Tokyo, Japan.'}, {'ForeName': 'Eriko', 'Initials': 'E', 'LastName': 'Satomi', 'Affiliation': 'Department of Palliative Medicine, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Hiroto', 'Initials': 'H', 'LastName': 'Ishiki', 'Affiliation': 'Department of Palliative Medicine, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Hideaki', 'Initials': 'H', 'LastName': 'Hasuo', 'Affiliation': 'Department of Psychosomatic Internal Medicine, Kansai Medical University, Osaka, Japan.'}, {'ForeName': 'Hiroko', 'Initials': 'H', 'LastName': 'Sakuma', 'Affiliation': 'Department of Psychosomatic Internal Medicine, Kansai Medical University, Osaka, Japan.'}, {'ForeName': 'Akihiro', 'Initials': 'A', 'LastName': 'Tokoro', 'Affiliation': 'Department of Psychosomatic Internal Medicine, National Hospital Organization Kinki-Chuo Chest Medical Center, Sakai, Japan.'}, {'ForeName': 'Yoshinobu', 'Initials': 'Y', 'LastName': 'Matsuda', 'Affiliation': 'Department of Psychosomatic Internal Medicine, National Hospital Organization Kinki-Chuo Chest Medical Center, Sakai, Japan.'}, {'ForeName': 'Kazuki', 'Initials': 'K', 'LastName': 'Tahara', 'Affiliation': 'Yamanobe General Hospital Internal medicine, Nara, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Otani', 'Affiliation': 'Department of Palliative Medicine, National Kyushu Cancer Center, Fukuoka, Japan.'}, {'ForeName': 'Yoichi', 'Initials': 'Y', 'LastName': 'Ohtake', 'Affiliation': 'Itami Seifu Hospital Internal medicine, Hyogo, Japan.'}, {'ForeName': 'Hiroaki', 'Initials': 'H', 'LastName': 'Tsukuura', 'Affiliation': 'Nagoya University Hospital, Aichi, Japan.'}, {'ForeName': 'Yoshihisa', 'Initials': 'Y', 'LastName': 'Matsumoto', 'Affiliation': 'Department of Palliative Medicine, National Cancer Center East, Kashiwa, Japan.'}, {'ForeName': 'Yoshikazu', 'Initials': 'Y', 'LastName': 'Hasegawa', 'Affiliation': 'Department of Medical Oncology, Izumi City General Hospital, Izumi, Japan.'}, {'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Kataoka', 'Affiliation': 'Department of Respiratory Medicine, Hyogo Prefectural Amagasaki General Medical Center, Hyogo, Japan.'}, {'ForeName': 'Masatomo', 'Initials': 'M', 'LastName': 'Otsuka', 'Affiliation': 'Department of Palliative Medicine, Kindai University Nara Hospital, Nara, Japan.'}, {'ForeName': 'Kiyohiro', 'Initials': 'K', 'LastName': 'Sakai', 'Affiliation': 'Department of Psychosomatic Medicine, Kindai University Faculty of Medicine, Osaka, Japan.'}, {'ForeName': 'Miki', 'Initials': 'M', 'LastName': 'Nakura', 'Affiliation': 'Department of Psychosomatic Medicine, Kindai University Faculty of Medicine, Osaka, Japan.'}, {'ForeName': 'Tatsuya', 'Initials': 'T', 'LastName': 'Morita', 'Affiliation': 'Palliative and Supportive Care Division, Seirei Mikatahara General Hospital, Hamamatsu, Japan.'}, {'ForeName': 'Takuhiro', 'Initials': 'T', 'LastName': 'Yamaguchi', 'Affiliation': 'Division of Biostatistics, Tohoku University Graduate School of Medicine, Sendai, Japan.'}, {'ForeName': 'Atsuko', 'Initials': 'A', 'LastName': 'Koyama', 'Affiliation': 'Department of Psychosomatic Medicine, Kindai University Faculty of Medicine, Osaka, Japan.'}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-019-05138-9'] 114,31429599,Acute resveratrol supplementation in coronary artery disease: towards patient stratification.,"Objective: Resveratrol (RV) is a polyphenol with antioxidant, anti-inflammatory and cardio-protective properties. Our objective was to investigate whether acute supplementation with high doses of RV would improve flow-mediated dilation (FMD) and oxygen consumption (VO 2 ) kinetics in older coronary artery disease (CAD) patients. Design: We employed a placebo-controlled, single-blind, crossover design in which ten participants (aged 66.6 ± 7.8 years) received either RV or placebo (330 mg, 3× day -1 ) during three consecutive days plus additional 330 mg in the morning of the fourth day with a seven-day wash-out period in-between. On the fourth day, FMD of the brachial artery and VO 2 on-kinetics were determined. Results: RV improved FMD in patients who had undergone coronary artery bypass grafting (CABG; -1.4 vs . 5.0%; p =  .004), but not in those who had undergone percutaneous coronary intervention (PCI; 4.2 vs . -0.2%; NS). Conclusion: Acute high dose supplementation with RV improved FMD in patients after CABG surgery but impaired FMD in patients who underwent PCI. The revascularization method-related differential effects of RV may be due to its direct effects on endothelial-dependent dilator responses. Our findings have important implications for personalized treatment and stratification of older CAD patients.",2020,RV improved FMD in patients who had undergone coronary artery bypass grafting (CABG; -1.4 vs .,"['patients who had undergone coronary artery bypass grafting (CABG; -1.4 vs ', 'older coronary artery disease (CAD) patients', 'older CAD patients', 'ten participants (aged 66.6\u2009±\u20097.8\u2009years', 'coronary artery disease']","['RV or placebo', 'Resveratrol (RV', 'placebo', 'Acute resveratrol supplementation']","['flow-mediated dilation (FMD) and oxygen consumption (VO 2 ) kinetics', 'FMD', 'RV improved FMD', 'FMD of the brachial artery and VO 2 on-kinetics']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0010055', 'cui_str': 'Coronary Artery Bypass Grafting'}, {'cui': 'C4517503', 'cui_str': '1.4 (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2930481', 'cui_str': 'cis-Resveratrol'}]","[{'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}, {'cui': 'C1322279', 'cui_str': 'Dilation'}, {'cui': 'C1305742', 'cui_str': 'Oxygen consumption'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0006087', 'cui_str': 'Brachial Artery'}]",10.0,0.27069,RV improved FMD in patients who had undergone coronary artery bypass grafting (CABG; -1.4 vs .,"[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Diaz', 'Affiliation': 'Department of Life Sciences, Faculty of Science and Engineering, Manchester Metropolitan University, Manchester, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Avila', 'Affiliation': 'Department of Life Sciences, Faculty of Science and Engineering, Manchester Metropolitan University, Manchester, UK.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Degens', 'Affiliation': 'Department of Life Sciences, Faculty of Science and Engineering, Manchester Metropolitan University, Manchester, UK.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Coeckelberghs', 'Affiliation': 'Research Group for Cardiovascular and Respiratory Rehabilitation, Department of Rehabilitation Sciences, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Vanhees', 'Affiliation': 'Research Group for Cardiovascular and Respiratory Rehabilitation, Department of Rehabilitation Sciences, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Cornelissen', 'Affiliation': 'Research Group for Cardiovascular and Respiratory Rehabilitation, Department of Rehabilitation Sciences, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Azzawi', 'Affiliation': 'Department of Life Sciences, Faculty of Science and Engineering, Manchester Metropolitan University, Manchester, UK.'}]",Scandinavian cardiovascular journal : SCJ,['10.1080/14017431.2019.1657584'] 115,30935341,Dry needling versus trigger point compression of the upper trapezius: a randomized clinical trial with two-week and three-month follow-up.,"Objectives : The purpose of this randomized controlled trial was to investigate the long-term clinical effect of dry needling with two-week and three-month follow up, on individuals with myofascial trigger points in the upper trapezius muscle. Methods : A sample of convenience (33 individuals) with a trigger point in the upper trapezius muscle, participated in this study. The individuals were randomly assigned to two groups: trigger point compression ( N  = 17) or dry needling ( N  = 16). Pain intensity, neck disability, and disability of the arm, hand, and shoulder (DASH) were assessed before treatment, after treatment sessions, and at two-week and three-month follow ups. Results : The result of repeated measures ANOVA showed significant group-measurement interaction effect for VAS ( p  = .02). No significant interaction was found for NPQ and DASH ( p  > .05). The main effect of measurements for VAS, NPQ, and DASH were statistically significant ( p  < .0001). The results showed a significant change in pain intensity, neck disability, and DASH after treatment sessions, after two weeks and three months when compared with before treatment scores in both groups.  There was no significant difference in the tested variables after two-week or three-month as compared to after treatment sessions between the two groups. However, pain intensity after treatment sessions was significantly different between the two groups ( p  = .02). Discussion : Dry needling and trigger point compression in individuals with myofascial trigger point in the upper trapezius muscle can lead to three-month improvement in pain intensity and disability.",2019,There was no significant difference in the tested variables after two-week or three-month as compared to after treatment sessions between the two groups.,"['Discussion ', 'individuals with myofascial trigger', 'individuals with myofascial trigger points in the upper trapezius muscle', 'A sample of convenience (33 individuals) with a trigger point in the upper trapezius muscle, participated in this study']","['Dry needling versus trigger point compression of the upper trapezius', 'Dry needling and trigger point compression', 'trigger point compression ( N \xa0=\xa017) or dry needling']","['NPQ and DASH', 'pain intensity and disability', 'Pain intensity, neck disability, and disability of the arm, hand, and shoulder (DASH', 'pain intensity', 'VAS, NPQ, and DASH', 'pain intensity, neck disability, and DASH']","[{'cui': 'C0557061', 'cui_str': 'Discussion (procedure)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C1444748', 'cui_str': 'Provoked by (attribute)'}, {'cui': 'C0458343', 'cui_str': 'Trigger point (body structure)'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0224361', 'cui_str': 'Trapezius'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0394648', 'cui_str': 'Dry needle acupuncture (procedure)'}, {'cui': 'C0458343', 'cui_str': 'Trigger point (body structure)'}, {'cui': 'C0332459', 'cui_str': 'Compression (morphologic abnormality)'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0224361', 'cui_str': 'Trapezius'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0027536', 'cui_str': 'Necking (finding)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0037004', 'cui_str': 'Shoulder'}]",,0.0361532,There was no significant difference in the tested variables after two-week or three-month as compared to after treatment sessions between the two groups.,"[{'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Ziaeifar', 'Affiliation': 'a Department of Physical Therapy , Iran University of Medical Sciences , Tehran , Iran.'}, {'ForeName': 'Amir Massoud', 'Initials': 'AM', 'LastName': 'Arab', 'Affiliation': 'b Department of Physical Therapy , University of Social Welfare and Rehabilitation Sciences , Tehran , Iran.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Mosallanezhad', 'Affiliation': 'b Department of Physical Therapy , University of Social Welfare and Rehabilitation Sciences , Tehran , Iran.'}, {'ForeName': 'Mohammad Reza', 'Initials': 'MR', 'LastName': 'Nourbakhsh', 'Affiliation': 'c Department of Physical Therapy , North Georgia College and State University , Dahlonega , GA , USA.'}]",The Journal of manual & manipulative therapy,['10.1080/10669817.2018.1530421'] 116,31707500,Feasibility of a randomized controlled trial of symptom screening and feedback to healthcare providers compared with standard of care using the SPARK platform.,"PURPOSE Supportive care Prioritization, Assessment and Recommendations for Kids (SPARK) is a web-based application that enables symptom screening and access to clinical practice guidelines for symptom management. Objective was to determine the feasibility of a randomized trial of daily symptom screening for 5 days among children receiving cancer treatments. METHODS We included English-speaking pediatric cancer and hematopoietic stem cell transplantation (HSCT) patients who were 8-18 years of age at enrollment and who were expected to be in the hospital or in clinic daily for five consecutive days. We randomized children to either undergo daily symptom screening with symptom reports provided to the healthcare team using the SPARK vs. standard of care. The primary endpoint was feasibility, defined as being able to enroll at least 30 participants within 1 year, and among those randomized to intervention, at least 75% completing symptom screening on at least 60% of on-study days. RESULTS From July 2018 to November 2018, we enrolled and randomized 30 participants. The median age at enrollment was 12.5 (range 8-18) years. Among the intervention group, the median number of days Symptom Screening in Pediatrics Tool (SSPedi) was completed at least once was 5 (range 4 to 5), with one participant missing 1 day of symptom screening. Among all participants, baseline and day 5 SSPedi scores were obtained in 29/30 participants. CONCLUSION A randomized trial of the SPARK with daily symptom screening for 5 days was feasible. It is now appropriate to proceed toward a definitive multi-center trial to test the efficacy of SPARK to improve symptom control.",2020,"PURPOSE Supportive care Prioritization, Assessment and Recommendations for Kids (SPARK) is a web-based application that enables symptom screening and access to clinical practice guidelines for symptom management.","['Kids (SPARK', 'children receiving cancer treatments', 'From July 2018 to November 2018, we enrolled and randomized 30 participants', 'English-speaking pediatric cancer and hematopoietic stem cell transplantation (HSCT) patients who were 8-18\xa0years of age at enrollment and who were expected to be in the hospital or in clinic daily for five consecutive days']","['daily symptom screening', 'symptom screening and feedback to healthcare providers compared with standard of care using the SPARK platform', 'SPARK with daily symptom screening']",['median number of days Symptom Screening in Pediatrics Tool (SSPedi'],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C3540738', 'cui_str': 'English [International Organization for Standardization 639-1 code en] language reference set (foundation metadata concept)'}, {'cui': 'C0234856', 'cui_str': 'Using spoken communication'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0472699', 'cui_str': 'Hematopoietic Stem Cell Transplantation'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]","[{'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0018724', 'cui_str': 'Healthcare Workers'}, {'cui': 'C2936643', 'cui_str': 'Standard of Care'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0336791', 'cui_str': 'Tool, device (physical object)'}]",30.0,0.21019,"PURPOSE Supportive care Prioritization, Assessment and Recommendations for Kids (SPARK) is a web-based application that enables symptom screening and access to clinical practice guidelines for symptom management.","[{'ForeName': 'Sadie', 'Initials': 'S', 'LastName': 'Cook', 'Affiliation': 'Program in Child Health Evaluative Sciences, The Hospital for Sick Children, Peter Gilgan Centre for Research and Learning, 686 Bay Street, Toronto, Ontario, M5G 0A4, Canada.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Vettese', 'Affiliation': 'Program in Child Health Evaluative Sciences, The Hospital for Sick Children, Peter Gilgan Centre for Research and Learning, 686 Bay Street, Toronto, Ontario, M5G 0A4, Canada.'}, {'ForeName': 'George A', 'Initials': 'GA', 'LastName': 'Tomlinson', 'Affiliation': 'Department of Medicine, Toronto General Hospital, 200 Elizabeth Street, Toronto, Ontario, M5G 2C4, Canada.'}, {'ForeName': 'Dilip', 'Initials': 'D', 'LastName': 'Soman', 'Affiliation': 'Rotman School of Management, University of Toronto, 105 St. George Street, Toronto, Ontario, M5S 3E6, Canada.'}, {'ForeName': 'Tal', 'Initials': 'T', 'LastName': 'Schechter', 'Affiliation': 'Division of Haematology/Oncology, The Hospital for Sick Children, 555 University Avenue, Toronto, Ontario, M5G 1X8, Canada.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Kuczynski', 'Affiliation': 'Ontario Parents Advocating for Children with Cancer (OPACC), 99 Citation Drive, Toronto, Ontario, M2K 1S9, Canada.'}, {'ForeName': 'Brenda', 'Initials': 'B', 'LastName': 'Gladstone', 'Affiliation': 'Dalla Lana School of Public Health, University of Toronto, 105 St. George Street, Toronto, Ontario, M5S 3E6, Canada.'}, {'ForeName': 'L Lee', 'Initials': 'LL', 'LastName': 'Dupuis', 'Affiliation': 'Department of Pharmacy, The Hospital for Sick Children, 555 University Avenue, Toronto, Ontario, M5G 1X8, Canada.'}, {'ForeName': 'Lillian', 'Initials': 'L', 'LastName': 'Sung', 'Affiliation': 'Program in Child Health Evaluative Sciences, The Hospital for Sick Children, Peter Gilgan Centre for Research and Learning, 686 Bay Street, Toronto, Ontario, M5G 0A4, Canada. lillian.sung@sickkids.ca.'}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-019-05115-2'] 117,31769212,"Maintenance of Efficacy and Safety of Ustekinumab Through One Year in a Phase II Multicenter, Prospective, Randomized, Double-Blind, Placebo-Controlled Crossover Trial of Patients With Active Systemic Lupus Erythematosus.","OBJECTIVE To evaluate the efficacy and safety of ustekinumab through 1 year in a phase II trial in patients with systemic lupus erythematosus (SLE). METHODS Eligible patients were diagnosed as having clinically active SLE (based on Systemic Lupus International Collaborating Clinics criteria), despite standard background therapy. Active disease was defined by an SLE Disease Activity Index 2000 (SLEDAI-2K) score of ≥6 as well as having ≥1 British Isles Lupus Assessment Group (BILAG) A organ domain score and/or ≥2 BILAG B organ domain scores present at screening. Patients (n = 102) were randomized (3:2) to receive either ustekinumab (~6 mg/kg of single intravenous infusion at week 0, then 90-mg subcutaneous injections every 8 weeks beginning at week 8) or a matching placebo added to standard therapy. At week 24, the placebo group crossed over to receive a subcutaneous 90-mg dose of ustekinumab every 8 weeks, and the original ustekinumab group continued to receive therapy through week 40. Maintenance of efficacy was assessed using the SLEDAI-2K, the SLE Responder Index 4 (SRI-4), physician global assessment, and mucocutaneous and joint disease measures in a modified intent-to-treat population. RESULTS SRI-4 response rates were significantly greater in the ustekinumab group (62%) versus the placebo group (33%) in the week 24 primary end point analysis (P = 0.006) and were maintained at week 48 (63.3%) in the ustekinumab group. In the ustekinumab group, response rates across other disease measures were also maintained through week 48. Among patients in the placebo group who crossed over to ustekinumab treatment (n = 33), increased response rates across efficacy measures were noted. Among all ustekinumab-treated patients, 81.7% had ≥1 adverse event (AE), and 15.1% had ≥1 serious AE through week 56. No deaths, malignancies, opportunistic infections, or tuberculosis cases were observed. CONCLUSION Ustekinumab provided sustained clinical benefit in patients with SLE through 1 year, with a safety profile consistent with other indications.",2020,"RESULTS SRI-4 response rate was significantly greater (p=0.006) in the ustekinumab group (62%) vs placebo (33%) in the week 24 primary endpoint analysis and maintained at week 48 (63.3%) in the ustekinumab group.","['patients with active systemic lupus erythematosus', 'Patients (n=102', 'Eligible patients had clinically active SLE (SLE International Collaborating Clinics criteria) despite standard background therapy']","['placebo', 'ustekinumab']","['response rates across efficacy measures', ""SLEDAI-2K, SLE Responder Index 4 (SRI-4), Physician's Global Assessment, and mucocutaneous and joint disease measures"", 'efficacy and safety', 'SLE Disease Activity Index 2000 (SLEDAI-2K) score ≥6 and ≥1 British Isles Lupus Assessment Group (BILAG', 'SRI-4 response rate', 'response rates', 'No deaths, malignancies, opportunistic infections, or tuberculosis cases']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0024141', 'cui_str': 'Lupus Erythematosus Disseminatus'}, {'cui': 'C1141000', 'cui_str': 'Sled, device (physical object)'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1608841', 'cui_str': 'ustekinumab'}]","[{'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C1141000', 'cui_str': 'Sled, device (physical object)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0022408', 'cui_str': 'Arthropathy'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0409974', 'cui_str': 'Lupus erythematosus (disorder)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0029118', 'cui_str': 'Opportunistic Infections'}, {'cui': 'C0041296', 'cui_str': 'Mycobacterium tuberculosis Infection'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}]",,0.480577,"RESULTS SRI-4 response rate was significantly greater (p=0.006) in the ustekinumab group (62%) vs placebo (33%) in the week 24 primary endpoint analysis and maintained at week 48 (63.3%) in the ustekinumab group.","[{'ForeName': 'Ronald F', 'Initials': 'RF', 'LastName': 'van Vollenhoven', 'Affiliation': 'University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Bevra H', 'Initials': 'BH', 'LastName': 'Hahn', 'Affiliation': 'University of California, Los Angeles.'}, {'ForeName': 'George C', 'Initials': 'GC', 'LastName': 'Tsokos', 'Affiliation': 'Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Lipsky', 'Affiliation': 'AMPEL BioSolutions, LLC, Charlottesville, Virginia.'}, {'ForeName': 'Kaiyin', 'Initials': 'K', 'LastName': 'Fei', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, Pennsylvania.'}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Gordon', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, Pennsylvania.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Gregan', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, Pennsylvania.'}, {'ForeName': 'Kim Hung', 'Initials': 'KH', 'LastName': 'Lo', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, Pennsylvania.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Chevrier', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, Pennsylvania.'}, {'ForeName': 'Shawn', 'Initials': 'S', 'LastName': 'Rose', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, Pennsylvania.'}]","Arthritis & rheumatology (Hoboken, N.J.)",['10.1002/art.41179'] 118,30935327,"A randomized clinical trial comparing non-thrust manipulation with segmental and distal dry needling on pain, disability, and rate of recovery for patients with non-specific low back pain.","Objective : The purpose of this study was to examine the within and between-group effects of segmental and distal dry needling (DN) without needle manipulation to a semi-standardized non-thrust manipulation (NTM) targeting the symptomatic spinal level for patients with non-specific low back pain (NSLBP). Methods : Sixty-five patients with NSLBP were randomized to receive either DN ( n  = 30) or NTM ( n  = 35) for six sessions over 3 weeks. Outcomes collected included the oswestry disability index (ODI), patient specific functional scale (PSFS), numeric pain rating scale (NPRS), and pain pressure thresholds (PPT). At discharge, patients perceived recovery was assessed. Results : A two-way mixed model ANOVA demonstrated that there was no group*time interaction for PSFS ( p  = 0.26), ODI ( p  = 0.57), NPRS ( p  = 0.69), and PPT ( p  = 0.51). There was significant within group effects for PSFS (3.1 [2.4, 3.8], p  = 0.018), ODI (14.5% [10.0%, 19.0%], p  = 0.015), NPRS (2.2 [1.5, 2.8], p  = 0.009), but not for PPT (3.3 [0.5, 6.0], p  = 0.20). Discussion : The between-group effects were neither clinically nor statistically significant. The within group effects were both significant and exceeded the reported minimum clinically important differences for the outcomes tools except the PPT. DN and NTM produced comparable outcomes in this sample of patients with NSLBP. Level of evidence: 1b.",2019,"There was significant within group effects for PSFS (3.1 [2.4, 3.8], p  = 0.018), ODI (14.5% [10.0%, 19.0%], p  = 0.015), NPRS (2.2 [1.5, 2.8], p  = 0.009), but not for PPT (3.3 [0.5, 6.0], p  = 0.20). ","['patients with non-specific low back pain', 'patients with NSLBP', 'Sixty-five patients with NSLBP', 'patients with non-specific low back pain (NSLBP', 'Discussion ']","['NTM', 'non-thrust manipulation with segmental and distal dry needling', 'DN and NTM', 'segmental and distal dry needling (DN) without needle manipulation to a semi-standardized non-thrust manipulation (NTM', 'DN']","['pain, disability, and rate of recovery', 'group*time interaction for PSFS', 'oswestry disability index (ODI), patient specific functional scale (PSFS), numeric pain rating scale (NPRS), and pain pressure thresholds (PPT', 'PSFS', 'NPRS', 'ODI']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205370', 'cui_str': 'Non-specific (qualifier value)'}, {'cui': 'C0024031', 'cui_str': 'Low Back Ache'}, {'cui': 'C0450385', 'cui_str': '65 (qualifier value)'}, {'cui': 'C0557061', 'cui_str': 'Discussion (procedure)'}]","[{'cui': 'C1265234', 'cui_str': 'Non-Tuberculous Mycobacteria'}, {'cui': 'C0947647', 'cui_str': 'Manipulation - action (qualifier value)'}, {'cui': 'C0205122', 'cui_str': 'Segmental (qualifier value)'}, {'cui': 'C0205108', 'cui_str': 'Distal (qualifier value)'}, {'cui': 'C0394648', 'cui_str': 'Dry needle acupuncture (procedure)'}, {'cui': 'C0398296', 'cui_str': 'Cannulation of vascular fistula, graft or prosthetic device (procedure)'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index (assessment scale)'}, {'cui': 'C4304943', 'cui_str': 'Patient-Specific Functional Scale (assessment scale)'}, {'cui': 'C0222045'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0449864', 'cui_str': 'Threshold (property) (qualifier value)'}]",65.0,0.105789,"There was significant within group effects for PSFS (3.1 [2.4, 3.8], p  = 0.018), ODI (14.5% [10.0%, 19.0%], p  = 0.015), NPRS (2.2 [1.5, 2.8], p  = 0.009), but not for PPT (3.3 [0.5, 6.0], p  = 0.20). ","[{'ForeName': 'D', 'Initials': 'D', 'LastName': 'Griswold', 'Affiliation': 'a Department of Physical Therapy , Youngstown State University , Youngstown , OH , USA.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Gargano', 'Affiliation': 'b President of Integrative Dry Needling , Solon , OH , USA.'}, {'ForeName': 'K E', 'Initials': 'KE', 'LastName': 'Learman', 'Affiliation': 'a Department of Physical Therapy , Youngstown State University , Youngstown , OH , USA.'}]",The Journal of manual & manipulative therapy,['10.1080/10669817.2019.1574389'] 119,31494734,"A randomized, controlled trial of the efficacy of percutaneous transesophageal gastro-tubing (PTEG) as palliative care for patients with malignant bowel obstruction: the JIVROSG0805 trial.","BACKGROUND A randomized, controlled trial to evaluate the superiority of percutaneous transesophageal gastro-tubing over nasogastric tubing as palliative care for bowel obstruction in patients with terminal malignancy was conducted. SUBJECTS AND METHODS The subjects were patients with malignant bowel obstruction with no prospect of improvement, for whom surgery was not indicated and with a Palliative Prognostic Index of < 6. They were randomly allocated in a 1:1 ratio to receive either percutaneous transesophageal gastro-tubing (PTEG group) or nasogastric tubing (NGT group). Their symptom scores (the worst 0 to no symptoms 10) were measured for a 2-week period after enrollment, and the areas under the curves for the two groups were compared. The EQ-5D and SF-8 were also used to assess overall quality of life. RESULTS Forty patients were enrolled between October 2009 and January 2015, with 21 allocated to the PTEG group and 19 to the NGT group. The mean areas under the curves (95% confidence intervals) for the PTEG group and the NGT groups were 149.6 (120.3-178.8) and 44.9 (16.4-73.5), respectively, significantly higher for the NGT group (p < 0.0001). The secondary endpoints of quality of life as assessed by the EQ-5D and SF-8 scores were also significantly higher for patients in the PTEG group (p = 0.0036, p = 0.0020). There was no difference in survival between the groups. No serious adverse events were observed. CONCLUSIONS In terms of quality of life, percutaneous transesophageal gastro-tubing was superior to nasogastric tubing as palliative care for patients with bowel obstruction due to terminal malignancy.",2020,"In terms of quality of life, percutaneous transesophageal gastro-tubing was superior to nasogastric tubing as palliative care for patients with bowel obstruction due to terminal malignancy.","['patients with malignant bowel obstruction', 'patients with bowel obstruction due to terminal malignancy', 'Forty patients were enrolled between October 2009 and January 2015, with 21 allocated to the PTEG group and 19 to the NGT group', 'subjects were patients with malignant bowel obstruction with no prospect of improvement, for whom surgery was not indicated and with a Palliative Prognostic Index of <\u20096', 'patients with terminal malignancy']","['percutaneous transesophageal gastro-tubing (PTEG', 'percutaneous transesophageal gastro-tubing over nasogastric tubing', 'percutaneous transesophageal gastro-tubing was superior to nasogastric tubing', 'percutaneous transesophageal gastro-tubing (PTEG group) or nasogastric tubing (NGT group', 'PTEG']","['quality of life as assessed by the EQ-5D and SF-8 scores', 'overall quality of life', 'serious adverse events', 'survival']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3888580'}, {'cui': 'C0021843', 'cui_str': 'Intestinal Obstruction'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C1444655', 'cui_str': 'Not indicated'}, {'cui': 'C1285530', 'cui_str': 'Palliative'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]","[{'cui': 'C0522523', 'cui_str': 'Percutaneous approach - access (qualifier value)'}, {'cui': 'C0522518', 'cui_str': 'Transesophageal approach (qualifier value)'}, {'cui': 'C0184165', 'cui_str': 'Tubing (physical object)'}, {'cui': 'C4318415', 'cui_str': 'Tube (unit of presentation)'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0034380'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",40.0,0.102998,"In terms of quality of life, percutaneous transesophageal gastro-tubing was superior to nasogastric tubing as palliative care for patients with bowel obstruction due to terminal malignancy.","[{'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Aramaki', 'Affiliation': 'Division of Interventional Radiology, Shizuoka Cancer Center, 1007 Shimonagakubo, Sunto-gun Nagaizumi-cho, Shizuoka, Japan. t.aramaki@scchr.jp.'}, {'ForeName': 'Yasuaki', 'Initials': 'Y', 'LastName': 'Arai', 'Affiliation': 'Department of Diagnostic Radiology, National Cancer Center Hospital, 5-1-1 Tsukiji, Chuo-ku, Tokyo, Japan.'}, {'ForeName': 'Yoshito', 'Initials': 'Y', 'LastName': 'Takeuchi', 'Affiliation': 'Department of Radiology, Fukuchiyama City Hospital, 231 Atsunaka-cho, Fukutiyama, Kyoto, Japan.'}, {'ForeName': 'Miyuki', 'Initials': 'M', 'LastName': 'Sone', 'Affiliation': 'Department of Diagnostic Radiology, National Cancer Center Hospital, 5-1-1 Tsukiji, Chuo-ku, Tokyo, Japan.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Sato', 'Affiliation': 'Division of Interventional Radiology, Shizuoka Cancer Center, 1007 Shimonagakubo, Sunto-gun Nagaizumi-cho, Shizuoka, Japan.'}, {'ForeName': 'Emima', 'Initials': 'E', 'LastName': 'Bekku', 'Affiliation': 'Department of Surgery, Tokyo Dental college Ichikawa General Hospital, 5-11-13 Sugano, Ichikawa, Chiba, Japan.'}, {'ForeName': 'Michihisa', 'Initials': 'M', 'LastName': 'Moriguchi', 'Affiliation': 'Department of Molecular Gastroenterology and Hepatology, Kyoto Prefectural University of Medicine Graduate School of Medical Science, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto, Japan.'}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-019-05066-8'] 120,32331460,"The Effects of Biofeedback Training and Smartphone-Delivered Biofeedback Training on Resilience, Occupational Stress, and Depressive Symptoms among Abused Psychiatric Nurses.","Psychiatric ward (PW) nurses are at a higher risk to encounter workplace violence than are other healthcare providers, and many interventions have been developed to improve their mental health. We compared the effectiveness of biofeedback training (BT) and smartphone-delivered BT (SDBT) interventions on occupational stress, depressive symptoms, resilience, heart rate variability, and respiration rate in a sample of abused PW nurses. This was a quasi-experimental study. Structured questionnaires were administered before and six weeks after the intervention. Data were collected from April 2017 to October 2017. A total of 159 abused PW nurses were randomly assigned to BT, SDBT, and control groups, and 135 of them completed all processes of our protocol, with the study consisting of 119 females (88.1%) and 16 males (11.9%) and their age range being from 22 to 59 with the mean age of 35.61 and a standard deviation of 8.16. Compared to the controls, both the BT and the SDBT intervention groups experienced significant improvements in depressive symptoms, resilience, and respiration rate; and the SDBT group experienced significant reductions in occupational stress. Considering the cost, accessibility, restrictions time and space, SDBT be used as an effective intervention in people with resilience or occupational stress.",2020,"Compared to the controls, both the BT and the SDBT intervention groups experienced significant improvements in depressive symptoms, resilience, and respiration rate; and the SDBT group experienced significant reductions in occupational stress.","['people with resilience or occupational stress', 'Abused Psychiatric Nurses', ' and control groups, and 135 of them completed all processes of our protocol, with the study consisting of 119 females (88.1%) and 16 males (11.9%) and their age range being from 22 to 59 with the mean age of 35.61 and a standard deviation of 8.16', '159 abused PW nurses']","['biofeedback training (BT) and smartphone-delivered BT (SDBT) interventions', 'SDBT intervention', 'Biofeedback Training and Smartphone-Delivered Biofeedback Training', 'BT, SDBT']","['occupational stress, depressive symptoms, resilience, heart rate variability, and respiration rate', 'Resilience, Occupational Stress, and Depressive Symptoms', 'depressive symptoms, resilience, and respiration rate', 'occupational stress']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0683253', 'cui_str': 'Psychological resilience'}, {'cui': 'C0814090', 'cui_str': 'Job-related Stress'}, {'cui': 'C0562381', 'cui_str': 'Victim of abuse'}, {'cui': 'C0033870', 'cui_str': 'Nursing, Psychiatric'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4517566', 'cui_str': '135'}, {'cui': 'C0023449', 'cui_str': 'Acute lymphoid leukemia'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}]","[{'cui': 'C0005491', 'cui_str': 'Biofeedback procedure'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0814090', 'cui_str': 'Job-related Stress'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0683253', 'cui_str': 'Psychological resilience'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0231832', 'cui_str': 'Respiratory rate'}]",,0.0281066,"Compared to the controls, both the BT and the SDBT intervention groups experienced significant improvements in depressive symptoms, resilience, and respiration rate; and the SDBT group experienced significant reductions in occupational stress.","[{'ForeName': 'Hsiu-Fen', 'Initials': 'HF', 'LastName': 'Hsieh', 'Affiliation': 'School of Nursing, College of Nursing, Kaohsiung Medical University, No. 100, Shih-Chuan 1st Road, Kaohsiung 807, Taiwan.'}, {'ForeName': 'I-Chin', 'Initials': 'IC', 'LastName': 'Huang', 'Affiliation': 'School of Nursing, College of Nursing, Kaohsiung Medical University, No. 100, Shih-Chuan 1st Road, Kaohsiung 807, Taiwan.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'School of Nursing, College of Nursing, Kaohsiung Medical University, No. 100, Shih-Chuan 1st Road, Kaohsiung 807, Taiwan.'}, {'ForeName': 'Wen-Ling', 'Initials': 'WL', 'LastName': 'Chen', 'Affiliation': 'Department of Nursing, Tsyr-Huey Mental Hospital, Kaohsiung 831, Taiwan.'}, {'ForeName': 'Yi-Wen', 'Initials': 'YW', 'LastName': 'Lee', 'Affiliation': 'Nursing Department, Kaohsiung Chang Gung Memorial Hospital, Kaohsiung 833, Taiwan.'}, {'ForeName': 'Hsin-Tien', 'Initials': 'HT', 'LastName': 'Hsu', 'Affiliation': 'School of Nursing, College of Nursing, Kaohsiung Medical University, No. 100, Shih-Chuan 1st Road, Kaohsiung 807, Taiwan.'}]",International journal of environmental research and public health,['10.3390/ijerph17082905'] 121,31981516,"Efficacy of three neuroprotective drugs in secondary progressive multiple sclerosis (MS-SMART): a phase 2b, multiarm, double-blind, randomised placebo-controlled trial.","BACKGROUND Neurodegeneration is the pathological substrate that causes major disability in secondary progressive multiple sclerosis. A synthesis of preclinical and clinical research identified three neuroprotective drugs acting on different axonal pathobiologies. We aimed to test the efficacy of these drugs in an efficient manner with respect to time, cost, and patient resource. METHODS We did a phase 2b, multiarm, parallel group, double-blind, randomised placebo-controlled trial at 13 clinical neuroscience centres in the UK. We recruited patients (aged 25-65 years) with secondary progressive multiple sclerosis who were not on disease-modifying treatment and who had an Expanded Disability Status Scale (EDSS) score of 4·0-6·5. Participants were randomly assigned (1:1:1:1) at baseline, by a research nurse using a centralised web-based service, to receive twice-daily oral treatment of either amiloride 5 mg, fluoxetine 20 mg, riluzole 50 mg, or placebo for 96 weeks. The randomisation procedure included minimisation based on sex, age, EDSS score at randomisation, and trial site. Capsules were identical in appearance to achieve masking. Patients, investigators, and MRI readers were unaware of treatment allocation. The primary outcome measure was volumetric MRI percentage brain volume change (PBVC) from baseline to 96 weeks, analysed using multiple regression, adjusting for baseline normalised brain volume and minimisation criteria. The primary analysis was a complete-case analysis based on the intention-to-treat population (all patients with data at week 96). This trial is registered with ClinicalTrials.gov, NCT01910259. FINDINGS Between Jan 29, 2015, and June 22, 2016, 445 patients were randomly allocated amiloride (n=111), fluoxetine (n=111), riluzole (n=111), or placebo (n=112). The primary analysis included 393 patients who were allocated amiloride (n=99), fluoxetine (n=96), riluzole (n=99), and placebo (n=99). No difference was noted between any active treatment and placebo in PBVC (amiloride vs placebo, 0·0% [95% CI -0·4 to 0·5; p=0·99]; fluoxetine vs placebo -0·1% [-0·5 to 0·3; p=0·86]; riluzole vs placebo -0·1% [-0·6 to 0·3; p=0·77]). No emergent safety issues were reported. The incidence of serious adverse events was low and similar across study groups (ten [9%] patients in the amiloride group, seven [6%] in the fluoxetine group, 12 [11%] in the riluzole group, and 13 [12%] in the placebo group). The most common serious adverse events were infections and infestations. Three patients died during the study, from causes judged unrelated to active treatment; one patient assigned amiloride died from metastatic lung cancer, one patient assigned riluzole died from ischaemic heart disease and coronary artery thrombosis, and one patient assigned fluoxetine had a sudden death (primary cause) with multiple sclerosis and obesity listed as secondary causes. INTERPRETATION The absence of evidence for neuroprotection in this adequately powered trial indicates that exclusively targeting these aspects of axonal pathobiology in patients with secondary progressive multiple sclerosis is insufficient to mitigate neuroaxonal loss. These findings argue for investigation of different mechanistic targets and future consideration of combination treatment trials. This trial provides a template for future simultaneous testing of multiple disease-modifying medicines in neurological medicine. FUNDING Efficacy and Mechanism Evaluation (EME) Programme, an MRC and NIHR partnership, UK Multiple Sclerosis Society, and US National Multiple Sclerosis Society.",2020,"No difference was noted between any active treatment and placebo in PBVC (amiloride vs placebo, 0·0% [95% CI -0·4 to 0·5; p=0·99]; fluoxetine vs placebo -0·1% [-0·5 to 0·3; p=0·86]; riluzole vs placebo -0·1% [-0·6 to 0·3; p=0·77]).","['recruited patients (aged 25-65 years) with secondary progressive multiple sclerosis who were not on disease-modifying treatment and who had an Expanded Disability Status Scale (EDSS) score of 4·0-6·5', '13 clinical neuroscience centres in the UK', '393 patients who were allocated', 'secondary progressive multiple sclerosis (MS-SMART', 'primary cause) with multiple sclerosis and obesity listed as secondary causes', 'Between Jan 29, 2015, and June 22, 2016, 445 patients', 'patients with secondary progressive multiple sclerosis']","['PBVC (amiloride vs placebo', 'amiloride 5 mg, fluoxetine 20 mg, riluzole 50 mg, or placebo', 'fluoxetine', 'neuroprotective drugs', 'amiloride', 'placebo', 'riluzole']","['ischaemic heart disease and coronary artery thrombosis', 'sudden death', 'volumetric MRI percentage brain volume change (PBVC', 'incidence of serious adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0751965', 'cui_str': 'Multiple Sclerosis, Secondary Progressive'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0451246', 'cui_str': 'Kurtzke multiple sclerosis rating scale (assessment scale)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0027910', 'cui_str': 'Neurosciences'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C4517754', 'cui_str': 'Three hundred and ninety-three'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0026769', 'cui_str': 'MS (Multiple Sclerosis)'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}]","[{'cui': 'C0002502', 'cui_str': 'Amiloride'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0986112', 'cui_str': 'Fluoxetine 20 MG'}, {'cui': 'C1597541', 'cui_str': 'Riluzole 50 MG [Rilutek]'}, {'cui': 'C0016365', 'cui_str': 'Fluoxetine'}, {'cui': 'C0242912', 'cui_str': 'Neuroprotective Drugs'}, {'cui': 'C0073379', 'cui_str': 'Riluzole'}]","[{'cui': 'C0151744', 'cui_str': 'Ischemic Heart Disease'}, {'cui': 'C0010072', 'cui_str': 'Coronary Thrombosis'}, {'cui': 'C0011071', 'cui_str': 'Sudden death (event)'}, {'cui': 'C0445383', 'cui_str': 'Volumetric (qualifier value)'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",445.0,0.577543,"No difference was noted between any active treatment and placebo in PBVC (amiloride vs placebo, 0·0% [95% CI -0·4 to 0·5; p=0·99]; fluoxetine vs placebo -0·1% [-0·5 to 0·3; p=0·86]; riluzole vs placebo -0·1% [-0·6 to 0·3; p=0·77]).","[{'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Chataway', 'Affiliation': 'Queen Square Multiple Sclerosis Centre, Department of Neuroinflammation, University College London (UCL) Queen Square Institute of Neurology, Faculty of Brain Sciences, UCL, London, UK; National Institute for Health Research, University College London Hospitals, Biomedical Research Centre, London, UK. Electronic address: j.chataway@ucl.ac.uk.'}, {'ForeName': 'Floriana', 'Initials': 'F', 'LastName': 'De Angelis', 'Affiliation': 'Queen Square Multiple Sclerosis Centre, Department of Neuroinflammation, University College London (UCL) Queen Square Institute of Neurology, Faculty of Brain Sciences, UCL, London, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Connick', 'Affiliation': 'Centre for Clinical Brain Sciences, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Parker', 'Affiliation': 'Edinburgh Clinical Trials Unit, Usher Institute, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Domenico', 'Initials': 'D', 'LastName': 'Plantone', 'Affiliation': 'Queen Square Multiple Sclerosis Centre, Department of Neuroinflammation, University College London (UCL) Queen Square Institute of Neurology, Faculty of Brain Sciences, UCL, London, UK.'}, {'ForeName': 'Anisha', 'Initials': 'A', 'LastName': 'Doshi', 'Affiliation': 'Queen Square Multiple Sclerosis Centre, Department of Neuroinflammation, University College London (UCL) Queen Square Institute of Neurology, Faculty of Brain Sciences, UCL, London, UK.'}, {'ForeName': 'Nevin', 'Initials': 'N', 'LastName': 'John', 'Affiliation': 'Queen Square Multiple Sclerosis Centre, Department of Neuroinflammation, University College London (UCL) Queen Square Institute of Neurology, Faculty of Brain Sciences, UCL, London, UK.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Stutters', 'Affiliation': 'Queen Square Multiple Sclerosis Centre, Department of Neuroinflammation, University College London (UCL) Queen Square Institute of Neurology, Faculty of Brain Sciences, UCL, London, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'MacManus', 'Affiliation': 'Queen Square Multiple Sclerosis Centre, Department of Neuroinflammation, University College London (UCL) Queen Square Institute of Neurology, Faculty of Brain Sciences, UCL, London, UK.'}, {'ForeName': 'Ferran', 'Initials': 'F', 'LastName': 'Prados Carrasco', 'Affiliation': 'Queen Square Multiple Sclerosis Centre, Department of Neuroinflammation, University College London (UCL) Queen Square Institute of Neurology, Faculty of Brain Sciences, UCL, London, UK; Department of Medical Physics and Biomedical Engineering, Centre for Medical Image Computing, UCL, London, UK; Universitat Oberta de Catalunya, Barcelona, Spain; National Institute for Health Research, University College London Hospitals, Biomedical Research Centre, London, UK.'}, {'ForeName': 'Frederik', 'Initials': 'F', 'LastName': 'Barkhof', 'Affiliation': 'Queen Square Multiple Sclerosis Centre, Department of Neuroinflammation, University College London (UCL) Queen Square Institute of Neurology, Faculty of Brain Sciences, UCL, London, UK; Department of Medical Physics and Biomedical Engineering, Centre for Medical Image Computing, UCL, London, UK; Department of Radiology and Nuclear Medicine, VU University Medical Centre, Amsterdam, Netherlands; National Institute for Health Research, University College London Hospitals, Biomedical Research Centre, London, UK.'}, {'ForeName': 'Sebastien', 'Initials': 'S', 'LastName': 'Ourselin', 'Affiliation': ""School of Biomedical Engineering & Imaging Sciences, King's College London, London, UK.""}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Braisher', 'Affiliation': 'Queen Square Multiple Sclerosis Centre, Department of Neuroinflammation, University College London (UCL) Queen Square Institute of Neurology, Faculty of Brain Sciences, UCL, London, UK.'}, {'ForeName': 'Moira', 'Initials': 'M', 'LastName': 'Ross', 'Affiliation': 'Edinburgh Clinical Trials Unit, Usher Institute, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Gina', 'Initials': 'G', 'LastName': 'Cranswick', 'Affiliation': 'Edinburgh Clinical Trials Unit, Usher Institute, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Sue H', 'Initials': 'SH', 'LastName': 'Pavitt', 'Affiliation': 'Dental Translational and Clinical Research Unit, University of Leeds, Leeds, UK.'}, {'ForeName': 'Gavin', 'Initials': 'G', 'LastName': 'Giovannoni', 'Affiliation': 'Blizard Institute, Barts and The London School of Medicine and Dentistry, Queen Mary University, London, UK.'}, {'ForeName': 'Claudia Angela', 'Initials': 'CA', 'LastName': 'Gandini Wheeler-Kingshott', 'Affiliation': 'Queen Square Multiple Sclerosis Centre, Department of Neuroinflammation, University College London (UCL) Queen Square Institute of Neurology, Faculty of Brain Sciences, UCL, London, UK; Brain MRI 3T Research Center, IRCCS Mondino Foundation, Pavia, Italy; National Institute for Health Research, University College London Hospitals, Biomedical Research Centre, London, UK.'}, {'ForeName': 'Clive', 'Initials': 'C', 'LastName': 'Hawkins', 'Affiliation': 'Keele Medical School and Institute for Science and Technology in Medicine, Keele University, Keele, UK.'}, {'ForeName': 'Basil', 'Initials': 'B', 'LastName': 'Sharrack', 'Affiliation': 'Department of Neuroscience, Royal Hallamshire Hospital, Sheffield, UK.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Bastow', 'Affiliation': 'Patient Representative, Multiple Sclerosis Society, London, UK.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Weir', 'Affiliation': 'Edinburgh Clinical Trials Unit, Usher Institute, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Nigel', 'Initials': 'N', 'LastName': 'Stallard', 'Affiliation': 'Statistics and Epidemiology, Division of Health Sciences, Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'Siddharthan', 'Initials': 'S', 'LastName': 'Chandran', 'Affiliation': 'Centre for Clinical Brain Sciences, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Neurology,['10.1016/S1474-4422(19)30485-5'] 122,32333159,The Effects of Preferred Music on Laparoscopic Surgical Performance: A Randomized Crossover Study.,"INTRODUCTION Music can have a positive effect on stress and general task performance. This randomized crossover study assessed the effects of preferred music on laparoscopic surgical performance in a simulated setting. METHODS Sixty medical students, inexperienced in laparoscopy, were included between June 2018 and November 2018. A randomized, 4-period, 4-sequence, 2-treatment crossover study design was used, with each participant acting as its own control. Participants performed four periods, consisting of five peg transfer tasks each period, on a laparoscopic box trainer: two periods while wearing active noise-cancelling headphones and two periods during music exposure. Participants were randomly allocated to a sequence determining the order of the four periods. The parameters time to task completion, path length and normalized jerk were assessed. Mental workload was assessed using the Surgical Task Load Index questionnaire. Also, heart rate and blood pressure were assessed. RESULTS Participants performed the peg transfer task significantly faster [median difference: - 0.81 s (interquartile range, - 3.44-0.69) p = 0.037] and handled their instruments significantly more efficient as path length was reduced [median difference, - 52.24 mm (interquartile range, - 196.97-89.81) p = 0.019] when exposed to music. Also, mental workload was significantly reduced during music [median difference, - 2.41 (interquartile range, - 7.17-1.83) p = 0.021)]. No statistically significant effect was observed on heart rate and blood pressure. CONCLUSION Listening to preferred music improves laparoscopic surgical performance and reduces mental workload in a simulated setting. TRIAL REGISTRATION Trial registration number: NCT04111679.",2020,"RESULTS Participants performed the peg transfer task significantly faster [median difference: - 0.81 s (interquartile range, - 3.44-0.69) p = 0.037] and handled their instruments significantly more efficient as path length was reduced [median difference, - 52.24 mm (interquartile range, - 196.97-89.81) p = 0.019] when exposed to music.","['Sixty medical students, inexperienced in laparoscopy, were included between June 2018 and November 2018']","['Preferred Music', 'Listening to preferred music', 'laparoscopic box trainer: two periods while wearing active noise-cancelling headphones and two periods during music exposure']","['Surgical Task Load Index questionnaire', 'Laparoscopic Surgical Performance', 'Mental workload', 'parameters time to task completion, path length and normalized jerk', 'path length', 'mental workload', 'heart rate and blood pressure', 'laparoscopic surgical performance']","[{'cui': 'C0038495', 'cui_str': 'Medical student'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0004309', 'cui_str': 'Auditory Perception'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0006080', 'cui_str': 'Boxing'}, {'cui': 'C0453962', 'cui_str': 'Trainers'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C0205544', 'cui_str': 'Canceled'}, {'cui': 'C0441067', 'cui_str': 'Earphones'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}]","[{'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0085122', 'cui_str': 'Work Load'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0231530', 'cui_str': 'Muscle twitch'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}]",60.0,0.444156,"RESULTS Participants performed the peg transfer task significantly faster [median difference: - 0.81 s (interquartile range, - 3.44-0.69) p = 0.037] and handled their instruments significantly more efficient as path length was reduced [median difference, - 52.24 mm (interquartile range, - 196.97-89.81) p = 0.019] when exposed to music.","[{'ForeName': 'Pim', 'Initials': 'P', 'LastName': 'Oomens', 'Affiliation': 'Department of Surgery, Erasmus MC, University Medical Center Rotterdam, Doctor Molewaterplein 40, 3015 GD, Rotterdam, The Netherlands. pim.oomens@gmail.com.'}, {'ForeName': 'Victor X', 'Initials': 'VX', 'LastName': 'Fu', 'Affiliation': 'Department of Surgery, Erasmus MC, University Medical Center Rotterdam, Doctor Molewaterplein 40, 3015 GD, Rotterdam, The Netherlands.'}, {'ForeName': 'Vincent E E', 'Initials': 'VEE', 'LastName': 'Kleinrensink', 'Affiliation': 'Department of Neuroscience, Erasmus MC, University Medical Center Rotterdam, Doctor Molewaterplein 40, 3015 GD, Rotterdam, The Netherlands.'}, {'ForeName': 'Gert-Jan', 'Initials': 'GJ', 'LastName': 'Kleinrensink', 'Affiliation': 'Department of Neuroscience, Erasmus MC, University Medical Center Rotterdam, Doctor Molewaterplein 40, 3015 GD, Rotterdam, The Netherlands.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Jeekel', 'Affiliation': 'Department of Surgery, Erasmus MC, University Medical Center Rotterdam, Doctor Molewaterplein 40, 3015 GD, Rotterdam, The Netherlands.'}]",World journal of surgery,['10.1007/s00268-020-05523-0'] 123,32329198,Influence of low-level laser therapy on implant stability in implants placed in fresh extraction sockets: A randomized clinical trial.,"BACKGROUND Low-level laser therapy (LLLT) has been suggested to improve primary stability at the early stages of osseointegration in animal models. However, there is still scarce evidence about its influence on implant stability in humans. PURPOSE To assess the influence of LLLT on implant stability in implants placed in fresh extraction sockets. MATERIAL AND METHODS A randomized controlled trial was designed according to the SPIRIT guidelines and is reported following the CONSORT. Patients were randomly allocated according to control or LLLT groups. LLLT consisted in the application of GaAlAs laser (808 nm, avg. power density: 50 mW, circular spot diameter and area: 0.71 cm/0.4cm 2 ) applied in six points in contact mode with peri-implant soft tissue (1.23 minutes in each point of application; dose per point 11 J) before bone perforation and after suturing. The total dose resulted in 66 J per application moment. This LLLT protocol was applied only in the dental implant placement session. Implant stability was by ISQ at implant placement (T 0 ) and the abutment selection (T a ). Digital radiographs for T 0 and T a were used to assess the distance between the implant platform and alveolar bone crest, in millimeters. T-test and Shapiro-Wilk test were used to analyze data between groups using the implant as a unit of analysis. RESULTS Fifty implants were placed in 44 patients. The insertion torque ranged from 15 to 60 N.cm (mean 35.64 ± 13.34). Two implants of the LLLT and one of the control groups were lost to follow-up and one implant of the control group failed to osseointegrate (4.3%). ISQ at T 0 ranged from 17 to 79 (mean 59.33 ± 13.05) and from 40 to 89 (mean 66.46 SD ± 11.56) at T a . No differences were observed when comparing the groups with ISQ difference (P = .433) or radiographical peri-implant alterations (P = .261). CONCLUSIONS LLLT did not influence implant stability in implants placed in fresh extraction sockets when assessed at healing abutment installation.",2020,"No differences were observed when comparing the groups with ISQ difference (P = .433) or radiographical peri-implant alterations (P = .261). ","['implants placed in fresh extraction sockets', 'Fifty implants were placed in 44 patients']","['LLLT', 'GaAlAs laser', 'low-level laser therapy', 'control or LLLT', 'Low-level laser therapy (LLLT']","['Implant stability', 'implant stability', 'Digital radiographs for T 0 and T', 'ISQ']","[{'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0443224', 'cui_str': 'Fresh'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0224517', 'cui_str': 'Gomphosis structure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0279027', 'cui_str': 'Low power laser therapy'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C1306645', 'cui_str': 'Plain radiography'}]",50.0,0.0889852,"No differences were observed when comparing the groups with ISQ difference (P = .433) or radiographical peri-implant alterations (P = .261). ","[{'ForeName': 'Renan Pablo Bittencourt', 'Initials': 'RPB', 'LastName': 'Lobato', 'Affiliation': 'Graduate Program in Dentistry, Federal University of Pelotas, Pelotas, Brazil.'}, {'ForeName': 'Mateus de Azevedo', 'Initials': 'MA', 'LastName': 'Kinalski', 'Affiliation': 'Graduate Program in Dentistry, Federal University of Pelotas, Pelotas, Brazil.'}, {'ForeName': 'Thiago Marchi', 'Initials': 'TM', 'LastName': 'Martins', 'Affiliation': 'Graduate Program in Dentistry, Federal University of Pelotas, Pelotas, Brazil.'}, {'ForeName': 'Bernardo Antonio', 'Initials': 'BA', 'LastName': 'Agostini', 'Affiliation': 'Graduate Program in Dentistry, Meridional Faculty/IMED, Passo Fundo, Brazil.'}, {'ForeName': 'Cesar Dalmolin', 'Initials': 'CD', 'LastName': 'Bergoli', 'Affiliation': 'Graduate Program in Dentistry, Federal University of Pelotas, Pelotas, Brazil.'}, {'ForeName': 'Mateus Bertolini Fernandes', 'Initials': 'MBF', 'LastName': 'Dos Santos', 'Affiliation': 'Graduate Program in Dentistry, Federal University of Pelotas, Pelotas, Brazil.'}]",Clinical implant dentistry and related research,['10.1111/cid.12904'] 124,32325037,"Safety and immunogenicity of a modified vaccinia virus Ankara vector vaccine candidate for Middle East respiratory syndrome: an open-label, phase 1 trial.","BACKGROUND The Middle East respiratory syndrome coronavirus (MERS-CoV) causes a respiratory disease with a case fatality rate of up to 35%. Given its potential to cause a public health emergency and the absence of efficacious drugs or vaccines, MERS is one of the WHO priority diseases warranting urgent research and development of countermeasures. We aimed to assess safety and tolerability of an anti-MERS-CoV modified vaccinia virus Ankara (MVA)-based vaccine candidate that expresses the MERS-CoV spike glycoprotein, MVA-MERS-S, in healthy adults. METHODS This open-label, phase 1 trial was done at the University Medical Center Hamburg-Eppendorf (Hamburg, Germany). Participants were healthy men and women aged 18-55 years with no clinically significant health problems as determined during medical history and physical examination, a body-mass index of 18·5-30·0 kg/m 2 and weight of more than 50 kg at screening, and a negative pregnancy test for women. A key exclusion criterion was a previous MVA vaccination. For the prime immunisation, participants received doses of 1 × 10 7 plaque-forming unit (PFU; low-dose group) or 1 × 10 8 PFU (high-dose group) MVA-MERS-S intramuscularly. A second identical dose was administered intramuscularly as a booster immunisation 28 days after first injection. As a control group for immunogenicity analyses, blood samples were drawn at identical study timepoints from six healthy adults, who did not receive any injections. The primary objectives of the study were safety and tolerability of the two dosage levels and reactogenicity after administration. Immunogenicity was assessed as a secondary endpoint by ELISA and neutralisation tests. T-cell immunity was evaluated by interferon-γ-linked enzyme-linked immune absorbent spot assay. All participants who were vaccinated at least once were included in the safety analysis. Immunogenicity was analysed in the participants who completed 6 months of follow-up. This trial is registered with ClinicalTrials.gov, NCT03615911, and EudraCT, 2014-003195-23 FINDINGS: From Dec 17, 2017, to June 5, 2018, 26 participants (14 in the low-dose group and 12 in the high-dose group) were enrolled and received the first dose of the vaccine according to their group allocation. Of these, 23 participants (12 in the low-dose group and 11 in the high-dose group) received a second dose of MVA-MERS-S according to their group allocation after a 28-day interval and completed follow-up. Homologous prime-boost immunisation with MVA-MERS-S revealed a benign safety profile with only transient mild-to-moderate reactogenicity. Participants had no severe or serious adverse events. 67 vaccine-related adverse events were reported in ten (71%) of 14 participants in the low-dose group, and 111 were reported in ten (83%) of 12 participants in the high-dose group. Solicited local reactions were the most common adverse events: pain was observed in 17 (65%; seven in the low-dose group vs ten in the high-dose group) participants, swelling in ten (38%; two vs eight) participants, and induration in ten (38%; one vs nine) participants. Headaches (observed in seven participants in the low-dose group vs nine in the high-dose group) and fatigue or malaise (ten vs seven participants) were the most common solicited systemic adverse events. All adverse events resolved swiftly (within 1-3 days) and without sequelae. Following booster immunisation, nine (75%) of 12 participants in the low-dose group and 11 (100%) participants in the high-dose group showed seroconversion using a MERS-CoV S1 ELISA at any timepoint during the study. Binding antibody titres correlated with MERS-CoV-specific neutralising antibodies (Spearman's correlation r=0·86 [95% CI 0·6960-0·9427], p=0·0001). MERS-CoV spike-specific T-cell responses were detected in ten (83%) of 12 immunised participants in the low-dose group and ten (91%) of 11 immunised participants in the high-dose group. INTERPRETATION Vaccination with MVA-MERS-S had a favourable safety profile without serious or severe adverse events. Homologous prime-boost immunisation induced humoral and cell-mediated responses against MERS-CoV. A dose-effect relationship was demonstrated for reactogenicity, but not for vaccine-induced immune responses. The data presented here support further clinical testing of MVA-MERS-S in larger cohorts to advance MERS vaccine development. FUNDING German Center for Infection Research.",2020,"Homologous prime-boost immunisation induced humoral and cell-mediated responses against MERS-CoV. A dose-effect relationship was demonstrated for reactogenicity, but not for vaccine-induced immune responses.","['Participants were healthy men and women aged 18-55 years with no clinically significant health problems as determined during medical history and physical examination, a body-mass index of 18·5-30·0 kg/m 2 and weight of more than 50 kg at screening, and a negative pregnancy test for women', 'six healthy adults, who did not receive any injections', 'healthy adults', 'All participants who were vaccinated at least once were included in the safety analysis', 'Middle East respiratory syndrome', 'University Medical Center Hamburg-Eppendorf (Hamburg, Germany', ' From Dec 17, 2017, to June 5, 2018, 26 participants (14 in the low-dose group and 12 in the high-dose group', '2014-003195-23', '23 participants (12 in the low-dose group and 11 in the high-dose group']","['1\u2008×\u200810 7 plaque-forming unit (PFU; low-dose group) or 1\u2008×\u200810 8 PFU (high-dose group) MVA-MERS-S intramuscularly', 'MVA-MERS-S', 'modified vaccinia virus Ankara vector vaccine candidate', 'anti-MERS-CoV modified vaccinia virus Ankara (MVA)-based vaccine']","['adverse events', 'fatigue or malaise', 'Safety and immunogenicity', 'MERS-CoV spike-specific T-cell responses', 'safety and tolerability', 'Immunogenicity', 'severe or serious adverse events', 'seroconversion using a MERS-CoV S1 ELISA', 'Headaches', 'adverse events: pain']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0427780', 'cui_str': 'Pregnancy test negative'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C3694279', 'cui_str': 'Middle East respiratory syndrome'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0444956', 'cui_str': 'High dose'}]","[{'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0042216', 'cui_str': 'Vaccinia virus'}, {'cui': 'C0065973', 'cui_str': 'methanol extraction residue (MER) tubercle bacillus fraction'}, {'cui': 'C0012656', 'cui_str': 'Infectious Disease Vectors'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C3698360', 'cui_str': 'MERS-CoV'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0231218', 'cui_str': 'Malaise'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C3698360', 'cui_str': 'MERS-CoV'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C4042908', 'cui_str': 'Seroconversion'}, {'cui': 'C0014441', 'cui_str': 'Enzyme-linked immunosorbent assay'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",6.0,0.132455,"Homologous prime-boost immunisation induced humoral and cell-mediated responses against MERS-CoV. A dose-effect relationship was demonstrated for reactogenicity, but not for vaccine-induced immune responses.","[{'ForeName': 'Till', 'Initials': 'T', 'LastName': 'Koch', 'Affiliation': 'First Department of Medicine, Division of Infectious Diseases, University Medical Center Hamburg-Eppendorf, Hamburg, Germany; Department for Clinical Immunology of Infectious Diseases, Bernhard Nocht Institute for Tropical Medicine, Hamburg, Germany; German Center for Infection Research, Hamburg-Lubeck-Borstel-Riems, Germany.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Dahlke', 'Affiliation': 'First Department of Medicine, Division of Infectious Diseases, University Medical Center Hamburg-Eppendorf, Hamburg, Germany; Department for Clinical Immunology of Infectious Diseases, Bernhard Nocht Institute for Tropical Medicine, Hamburg, Germany; German Center for Infection Research, Hamburg-Lubeck-Borstel-Riems, Germany.'}, {'ForeName': 'Anahita', 'Initials': 'A', 'LastName': 'Fathi', 'Affiliation': 'First Department of Medicine, Division of Infectious Diseases, University Medical Center Hamburg-Eppendorf, Hamburg, Germany; Department for Clinical Immunology of Infectious Diseases, Bernhard Nocht Institute for Tropical Medicine, Hamburg, Germany; German Center for Infection Research, Hamburg-Lubeck-Borstel-Riems, Germany.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Kupke', 'Affiliation': 'German Center for Infection Research, Gießen-Marburg-Langen, Germany; Institute of Virology, Philipps University Marburg, Marburg, Germany.'}, {'ForeName': 'Verena', 'Initials': 'V', 'LastName': 'Krähling', 'Affiliation': 'German Center for Infection Research, Gießen-Marburg-Langen, Germany; Institute of Virology, Philipps University Marburg, Marburg, Germany.'}, {'ForeName': 'Nisreen M A', 'Initials': 'NMA', 'LastName': 'Okba', 'Affiliation': 'Department of Viroscience, Erasmus Medical Center, Rotterdam, Netherlands.'}, {'ForeName': 'Sandro', 'Initials': 'S', 'LastName': 'Halwe', 'Affiliation': 'German Center for Infection Research, Gießen-Marburg-Langen, Germany; Institute of Virology, Philipps University Marburg, Marburg, Germany.'}, {'ForeName': 'Cornelius', 'Initials': 'C', 'LastName': 'Rohde', 'Affiliation': 'German Center for Infection Research, Gießen-Marburg-Langen, Germany; Institute of Virology, Philipps University Marburg, Marburg, Germany.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Eickmann', 'Affiliation': 'German Center for Infection Research, Gießen-Marburg-Langen, Germany; Institute of Virology, Philipps University Marburg, Marburg, Germany.'}, {'ForeName': 'Asisa', 'Initials': 'A', 'LastName': 'Volz', 'Affiliation': 'German Center for Infection Research, Munich, Germany; Institute of Infectious Diseases and Zoonoses, University of Munich LMU, Munich, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Hesterkamp', 'Affiliation': 'German Center for Infection Research, Hanover-Brunswick, Germany.'}, {'ForeName': 'Alen', 'Initials': 'A', 'LastName': 'Jambrecina', 'Affiliation': 'Clinical Trial Center North, Hamburg, Germany.'}, {'ForeName': 'Saskia', 'Initials': 'S', 'LastName': 'Borregaard', 'Affiliation': 'Clinical Trial Center North, Hamburg, Germany.'}, {'ForeName': 'My L', 'Initials': 'ML', 'LastName': 'Ly', 'Affiliation': 'First Department of Medicine, Division of Infectious Diseases, University Medical Center Hamburg-Eppendorf, Hamburg, Germany; Department for Clinical Immunology of Infectious Diseases, Bernhard Nocht Institute for Tropical Medicine, Hamburg, Germany; German Center for Infection Research, Hamburg-Lubeck-Borstel-Riems, Germany.'}, {'ForeName': 'Madeleine E', 'Initials': 'ME', 'LastName': 'Zinser', 'Affiliation': 'First Department of Medicine, Division of Infectious Diseases, University Medical Center Hamburg-Eppendorf, Hamburg, Germany; Department for Clinical Immunology of Infectious Diseases, Bernhard Nocht Institute for Tropical Medicine, Hamburg, Germany; German Center for Infection Research, Hamburg-Lubeck-Borstel-Riems, Germany.'}, {'ForeName': 'Etienne', 'Initials': 'E', 'LastName': 'Bartels', 'Affiliation': 'First Department of Medicine, Division of Infectious Diseases, University Medical Center Hamburg-Eppendorf, Hamburg, Germany; Department for Clinical Immunology of Infectious Diseases, Bernhard Nocht Institute for Tropical Medicine, Hamburg, Germany; German Center for Infection Research, Hamburg-Lubeck-Borstel-Riems, Germany.'}, {'ForeName': 'Joseph S H', 'Initials': 'JSH', 'LastName': 'Poetsch', 'Affiliation': 'First Department of Medicine, Division of Infectious Diseases, University Medical Center Hamburg-Eppendorf, Hamburg, Germany; Department for Clinical Immunology of Infectious Diseases, Bernhard Nocht Institute for Tropical Medicine, Hamburg, Germany; German Center for Infection Research, Hamburg-Lubeck-Borstel-Riems, Germany.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Neumann', 'Affiliation': 'First Department of Medicine, Division of Infectious Diseases, University Medical Center Hamburg-Eppendorf, Hamburg, Germany; Department for Clinical Immunology of Infectious Diseases, Bernhard Nocht Institute for Tropical Medicine, Hamburg, Germany; German Center for Infection Research, Hamburg-Lubeck-Borstel-Riems, Germany.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Fux', 'Affiliation': 'Institute of Infectious Diseases and Zoonoses, University of Munich LMU, Munich, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Schmiedel', 'Affiliation': 'First Department of Medicine, Division of Infectious Diseases, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Ansgar W', 'Initials': 'AW', 'LastName': 'Lohse', 'Affiliation': 'First Department of Medicine, Division of Infectious Diseases, University Medical Center Hamburg-Eppendorf, Hamburg, Germany; German Center for Infection Research, Hamburg-Lubeck-Borstel-Riems, Germany.'}, {'ForeName': 'Bart L', 'Initials': 'BL', 'LastName': 'Haagmans', 'Affiliation': 'Department of Viroscience, Erasmus Medical Center, Rotterdam, Netherlands.'}, {'ForeName': 'Gerd', 'Initials': 'G', 'LastName': 'Sutter', 'Affiliation': 'German Center for Infection Research, Munich, Germany; Institute of Infectious Diseases and Zoonoses, University of Munich LMU, Munich, Germany.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Becker', 'Affiliation': 'German Center for Infection Research, Gießen-Marburg-Langen, Germany; Institute of Virology, Philipps University Marburg, Marburg, Germany.'}, {'ForeName': 'Marylyn M', 'Initials': 'MM', 'LastName': 'Addo', 'Affiliation': 'First Department of Medicine, Division of Infectious Diseases, University Medical Center Hamburg-Eppendorf, Hamburg, Germany; Department for Clinical Immunology of Infectious Diseases, Bernhard Nocht Institute for Tropical Medicine, Hamburg, Germany; German Center for Infection Research, Hamburg-Lubeck-Borstel-Riems, Germany. Electronic address: m.addo@uke.de.'}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(20)30248-6'] 125,32325038,"Safety and immunogenicity of a candidate Middle East respiratory syndrome coronavirus viral-vectored vaccine: a dose-escalation, open-label, non-randomised, uncontrolled, phase 1 trial.","BACKGROUND Cases of Middle East respiratory syndrome coronavirus (MERS-CoV) infection continue to rise in the Arabian Peninsula 7 years after it was first described in Saudi Arabia. MERS-CoV poses a significant risk to public health security because of an absence of currently available effective countermeasures. We aimed to assess the safety and immunogenicity of the candidate simian adenovirus-vectored vaccine expressing the full-length spike surface glycoprotein, ChAdOx1 MERS, in humans. METHODS This dose-escalation, open-label, non-randomised, uncontrolled, phase 1 trial was done at the Centre for Clinical Vaccinology and Tropical Medicine (Oxford, UK) and included healthy people aged 18-50 years with negative pre-vaccination tests for HIV antibodies, hepatitis B surface antigen, and hepatitis C antibodies (and a negative urinary pregnancy test for women). Participants received a single intramuscular injection of ChAdOx1 MERS at three different doses: the low-dose group received 5 × 10 9 viral particles, the intermediate-dose group received 2·5 × 10 10 viral particles, and the high-dose group received 5 × 10 10 viral particles. The primary objective was to assess safety and tolerability of ChAdOx1 MERS, measured by the occurrence of solicited, unsolicited, and serious adverse events after vaccination. The secondary objective was to assess the cellular and humoral immunogenicity of ChAdOx1 MERS, measured by interferon-γ-linked enzyme-linked immunospot, ELISA, and virus neutralising assays after vaccination. Participants were followed up for up to 12 months. This study is registered with ClinicalTrials.gov, NCT03399578. FINDINGS Between March 14 and Aug 15, 2018, 24 participants were enrolled: six were assigned to the low-dose group, nine to the intermediate-dose group, and nine to the high-dose group. All participants were available for follow-up at 6 months, but five (one in the low-dose group, one in the intermediate-dose group, and three in the high-dose group) were lost to follow-up at 12 months. A single dose of ChAdOx1 MERS was safe at doses up to 5 × 10 10 viral particles with no vaccine-related serious adverse events reported by 12 months. One serious adverse event reported was deemed to be not related to ChAdOx1 MERS. 92 (74% [95% CI 66-81]) of 124 solicited adverse events were mild, 31 (25% [18-33]) were moderate, and all were self-limiting. Unsolicited adverse events in the 28 days following vaccination considered to be possibly, probably, or definitely related to ChAdOx1 MERS were predominantly mild in nature and resolved within the follow-up period of 12 months. The proportion of moderate and severe adverse events was significantly higher in the high-dose group than in the intermediate-dose group (relative risk 5·83 [95% CI 2·11-17·42], p<0·0001) Laboratory adverse events considered to be at least possibly related to the study intervention were self-limiting and predominantly mild in severity. A significant increase from baseline in T-cell (p<0·003) and IgG (p<0·0001) responses to the MERS-CoV spike antigen was observed at all doses. Neutralising antibodies against live MERS-CoV were observed in four (44% [95% CI 19-73]) of nine participants in the high-dose group 28 days after vaccination, and 19 (79% [58-93]) of 24 participants had antibodies capable of neutralisation in a pseudotyped virus neutralisation assay. INTERPRETATION ChAdOx1 MERS was safe and well tolerated at all tested doses. A single dose was able to elicit both humoral and cellular responses against MERS-CoV. The results of this first-in-human clinical trial support clinical development progression into field phase 1b and 2 trials. FUNDING UK Department of Health and Social Care, using UK Aid funding, managed by the UK National Institute for Health Research.",2020,"Neutralising antibodies against live MERS-CoV were observed in four (44% [95% CI 19-73]) of nine participants in the high-dose group 28 days after vaccination, and 19 (79% [58-93]) of 24 participants had antibodies capable of neutralisation in a pseudotyped virus neutralisation assay. ","['healthy people aged 18-50 years with negative pre-vaccination tests for HIV antibodies, hepatitis B surface antigen, and hepatitis C antibodies (and a negative urinary pregnancy test for women', '24 participants were enrolled: six', 'Between March 14 and Aug 15, 2018', 'humans']","['single intramuscular injection of ChAdOx1 MERS', 'low-dose group received 5\u2008×\u200810 9 viral particles, the intermediate-dose group received 2·5\u2008×\u200810 10 viral particles, and the high-dose group received 5\u2008×\u200810 10 viral particles', 'candidate Middle East respiratory syndrome coronavirus viral-vectored vaccine', 'ChAdOx1 MERS']","['Unsolicited adverse events', 'cellular and humoral immunogenicity of ChAdOx1 MERS, measured by interferon-γ-linked enzyme-linked immunospot, ELISA, and virus neutralising assays', 'Safety and immunogenicity', 'safety and tolerability of ChAdOx1 MERS', 'serious adverse events', 'safe and well tolerated', 'safety and immunogenicity', 'Neutralising antibodies against live MERS-CoV', 'T-cell (p<0·003) and IgG (p<0·0001) responses to the MERS-CoV spike antigen', 'occurrence of solicited, unsolicited, and serious adverse events', 'proportion of moderate and severe adverse events']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0019683', 'cui_str': 'Human immunodeficiency virus antibody'}, {'cui': 'C0019168', 'cui_str': 'Hepatitis B surface antigen'}, {'cui': 'C0166049', 'cui_str': 'Antibody to hepatitis C virus'}, {'cui': 'C0032976', 'cui_str': 'Pregnancy detection examination'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0021492', 'cui_str': 'Intramuscular injection'}, {'cui': 'C0065973', 'cui_str': 'methanol extraction residue (MER) tubercle bacillus fraction'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0042760', 'cui_str': 'Virion'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C3698360', 'cui_str': 'MERS-CoV'}, {'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0012656', 'cui_str': 'Infectious Disease Vectors'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0007634', 'cui_str': 'Cell structure'}, {'cui': 'C0065973', 'cui_str': 'methanol extraction residue (MER) tubercle bacillus fraction'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C0014442', 'cui_str': 'Enzyme'}, {'cui': 'C0014441', 'cui_str': 'Enzyme-linked immunosorbent assay'}, {'cui': 'C0042769', 'cui_str': 'Viral disease'}, {'cui': 'C0005507', 'cui_str': 'Bioassay'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0475463', 'cui_str': 'Neutralizing antibody'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C3698360', 'cui_str': 'MERS-CoV'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0003320', 'cui_str': 'Antigen'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C1519275', 'cui_str': 'Common terminology criteria for adverse events grade 3'}]",24.0,0.0881364,"Neutralising antibodies against live MERS-CoV were observed in four (44% [95% CI 19-73]) of nine participants in the high-dose group 28 days after vaccination, and 19 (79% [58-93]) of 24 participants had antibodies capable of neutralisation in a pseudotyped virus neutralisation assay. ","[{'ForeName': 'Pedro M', 'Initials': 'PM', 'LastName': 'Folegatti', 'Affiliation': 'The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Mustapha', 'Initials': 'M', 'LastName': 'Bittaye', 'Affiliation': 'The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Flaxman', 'Affiliation': 'The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Fernando Ramos', 'Initials': 'FR', 'LastName': 'Lopez', 'Affiliation': 'The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Duncan', 'Initials': 'D', 'LastName': 'Bellamy', 'Affiliation': 'The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Kupke', 'Affiliation': 'Institute of Virology, Philipps University of Marburg, Marburg, Germany; German Center for Infection Research, Thematic Translational Unit Emerging Infections, Marburg, Germany.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Mair', 'Affiliation': 'The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Makinson', 'Affiliation': 'The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Sheridan', 'Affiliation': 'The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Cornelius', 'Initials': 'C', 'LastName': 'Rohde', 'Affiliation': 'Institute of Virology, Philipps University of Marburg, Marburg, Germany; German Center for Infection Research, Thematic Translational Unit Emerging Infections, Marburg, Germany.'}, {'ForeName': 'Sandro', 'Initials': 'S', 'LastName': 'Halwe', 'Affiliation': 'Institute of Virology, Philipps University of Marburg, Marburg, Germany; German Center for Infection Research, Thematic Translational Unit Emerging Infections, Marburg, Germany.'}, {'ForeName': 'Yuji', 'Initials': 'Y', 'LastName': 'Jeong', 'Affiliation': 'International Vaccine Institute, Science Unit, Seoul, South Korea.'}, {'ForeName': 'Young-Shin', 'Initials': 'YS', 'LastName': 'Park', 'Affiliation': 'International Vaccine Institute, Science Unit, Seoul, South Korea.'}, {'ForeName': 'Jae-Ouk', 'Initials': 'JO', 'LastName': 'Kim', 'Affiliation': 'International Vaccine Institute, Science Unit, Seoul, South Korea.'}, {'ForeName': 'Manki', 'Initials': 'M', 'LastName': 'Song', 'Affiliation': 'International Vaccine Institute, Science Unit, Seoul, South Korea.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Boyd', 'Affiliation': 'The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Nguyen', 'Initials': 'N', 'LastName': 'Tran', 'Affiliation': 'The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Silman', 'Affiliation': 'The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Poulton', 'Affiliation': 'The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Mehreen', 'Initials': 'M', 'LastName': 'Datoo', 'Affiliation': 'The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Marshall', 'Affiliation': 'The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Yrene', 'Initials': 'Y', 'LastName': 'Themistocleous', 'Affiliation': 'The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Lawrie', 'Affiliation': 'The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Roberts', 'Affiliation': 'The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Eleanor', 'Initials': 'E', 'LastName': 'Berrie', 'Affiliation': 'The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Becker', 'Affiliation': 'Institute of Virology, Philipps University of Marburg, Marburg, Germany; German Center for Infection Research, Thematic Translational Unit Emerging Infections, Marburg, Germany.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Lambe', 'Affiliation': 'The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Hill', 'Affiliation': 'The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Ewer', 'Affiliation': 'The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Gilbert', 'Affiliation': 'The Jenner Institute, Nuffield Department of Medicine, University of Oxford, Oxford, UK. Electronic address: sarah.gilbert@ndm.ox.ac.uk.'}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(20)30160-2'] 126,32333793,"Protective effects of dietary fish-oil supplementation on skin inflammatory and oxidative stress biomarkers induced by fine particulate air pollution: a pilot randomized, double-blind, placebo-controlled trial.","BACKGROUND Exposure to fine particulate matter (with an aerodynamic diameter ≤ 2·5 μm, PM 2·5 ) air pollution has been associated with skin-related diseases or disorders. OBJECTIVES To evaluate the potential skin-protective effects of fish-oil supplementation against PM 2·5 exposure. MATERIALS AND METHODS This is an exploratory analysis based on a pilot randomized, double-blind, placebo-controlled trial among 65 healthy young adults between September 2017 and January 2018 in Shanghai, China. We randomly assigned participants to take either fish oil or placebo 2·5 g daily for four consecutive months. Four rounds of skin D-Squame ® tape samples were collected in the last 2 months, and five secondary biomarkers of skin inflammation and oxidative stress were measured. Fixed-site PM 2·5 concentrations on campus were measured in real time. We used linear mixed-effect models to analyse the associations between short-term PM 2·5 exposure and biomarkers in each group. RESULTS The 24-h average PM 2·5 concentration was 34·68 ± 15·83 μg m -3 . There were generally weaker associations between PM 2·5 and biomarkers in the fish-oil group than in the placebo group, but the associations and the between-group differences varied by biomarkers and lag periods. Compared with the placebo group, for a 10-μg m -3 increase in PM 2·5 concentration, the increments of interleukin-1α and carbonyl protein in the fish-oil group were 41·55% smaller [95% confidence interval (CI) 4·61-78·48%] at lag 0-48 h and 22·01% smaller (95% CI 11·25-32·77%) at lag 0-24 h, respectively. No significant between-group differences were observed for other biomarkers. CONCLUSIONS This study suggested that dietary fish-oil supplementation may improve biomarkers of skin inflammation and oxidative-stress response to short-term PM 2·5 exposure.",2020,"There were generally weaker associations between PM 2.5 and biomarkers in the fish-oil group than in the placebo group, but the associations and the between-group differences varied by biomarkers and lag periods.","['65 healthy young adults between September 2017 and January 2018 in Shanghai, China', 'fine particulate air pollution']","['dietary fish-oil supplementation', 'fish-oil supplementation', 'placebo', 'fish oil or placebo']","['skin inflammation and oxidative stress', 'interleukin-1α and carbonyl protein', 'skin inflammation and oxidative-stress response', 'skin inflammatory and oxidative stress biomarkers']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0205232', 'cui_str': 'Fine'}, {'cui': 'C0457784', 'cui_str': 'Particulate'}, {'cui': 'C0001873', 'cui_str': 'Air pollution'}]","[{'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0016157', 'cui_str': 'Fish Oils'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0011603', 'cui_str': 'Dermatitis'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0021764', 'cui_str': 'Interleukin'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}]",65.0,0.612931,"There were generally weaker associations between PM 2.5 and biomarkers in the fish-oil group than in the placebo group, but the associations and the between-group differences varied by biomarkers and lag periods.","[{'ForeName': 'Z', 'Initials': 'Z', 'LastName': 'Lin', 'Affiliation': 'School of Public Health, Key Lab of Public Health Safety of the Ministry of Education and NHC Key Lab of Health Technology Assessment, Fudan University, Shanghai, 200032, China.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Niu', 'Affiliation': 'School of Public Health, Key Lab of Public Health Safety of the Ministry of Education and NHC Key Lab of Health Technology Assessment, Fudan University, Shanghai, 200032, China.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Jiang', 'Affiliation': 'School of Public Health, Key Lab of Public Health Safety of the Ministry of Education and NHC Key Lab of Health Technology Assessment, Fudan University, Shanghai, 200032, China.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Chen', 'Affiliation': 'School of Public Health, Key Lab of Public Health Safety of the Ministry of Education and NHC Key Lab of Health Technology Assessment, Fudan University, Shanghai, 200032, China.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Peng', 'Affiliation': 'Shanghai Typhoon Institute/CMA, Shanghai Key Laboratory of Meteorology and Health, Shanghai, 200030, China.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Mi', 'Affiliation': 'Unilever Research and Development Center, Shanghai, 200335, China.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Huang', 'Affiliation': 'Unilever Research and Development Center, Shanghai, 200335, China.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'Key Laboratory of Reproduction Regulation of National Population and Family Planning Commission, Shanghai Institute of Planned Parenthood Research, Institute of Reproduction and Development, Fudan University, Shanghai, 200032, China.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Xu', 'Affiliation': 'Department of Toxicology, School of Public Health, Anhui Medical University, Hefei, 230032, China.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Chen', 'Affiliation': 'School of Public Health, Key Lab of Public Health Safety of the Ministry of Education and NHC Key Lab of Health Technology Assessment, Fudan University, Shanghai, 200032, China.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Kan', 'Affiliation': 'School of Public Health, Key Lab of Public Health Safety of the Ministry of Education and NHC Key Lab of Health Technology Assessment, Fudan University, Shanghai, 200032, China.'}]",The British journal of dermatology,['10.1111/bjd.19156'] 127,32333714,Long-term follow-up after radiotherapy for prostate cancer with and without rectal hydrogel spacer: a pooled prospective evaluation of bowel-associated quality of life.,"OBJECTIVE To evaluate the long-term bowel-associated quality of life (QOL) in men after radiotherapy (RT) for prostate cancer with and without the use of rectal hydrogel spacer. PATIENTS AND METHODS The patients' QOL was examined using the Expanded Prostate Cancer Index Composite (EPIC) and mean changes from baseline in EPIC domains were evaluated. A total of 215 patients from a randomised multi-institutional trial of RT, with or without hydrogel spacer, with a QOL endpoint were pooled with 165 non-randomised patients from a single institution with prospective QOL collection in patients with or without hydrogel spacer. The proportions of men with minimally important differences (MIDs) relative to pre-treatment baseline in the bowel domain were tested using repeated measure logistic models with a pre-specified threshold for clinically significant declines (≥5 equivalent to MIDx1 and ≥10 equivalent to MIDx2). RESULTS A total of 380 men were evaluated (64% with spacer and 36% without) with QOL data being available for 199 men with >24 months of follow-up [median (range) 39.5 (31-71.4) months]. Treatment with spacer was associated with less decline in average long-term bowel QOL (89.4 for control and 94.7 for spacer) with differences at >24 months meeting the threshold of a MID difference between cohorts (bowel score difference from baseline: control = -5.1, spacer = 0.3, difference = -5.4; P < 0.001). When evaluated over time men without spacer were more likely to have MIDx1 (5 points) declines in bowel QOL (P = 0.01). At long-term follow-up MIDx1 was 36% without spacer vs 14% with spacer (P <0.001; odds ratio [OR] 3.5, 95% CI 1.7-6.9) while MIDx2 was seen in 19% vs 6% (P = 0.008; OR 3.6, 95% CI 1.4-9.1). The use of spacer was associated with less urgency with bowel movements (P = 0.002) and fewer loose stools (P = 0.009), as well as less bother with urgency (P = 0.007) and frequency of bowel movements (P = 0.009). CONCLUSIONS In this pooled analysis of QOL after prostate RT with up to 5 years of follow-up, use of a rectal spacer was associated with preservation of bowel QOL. This QOL benefit was preserved with long-term follow-up.",2020,"The use of spacer was associated with less urgency with bowel movements (p=0.002) and fewer loose stools (p=0.009) as well as less bother with urgency (0.007) and frequency of bowel movements (p=0.009). ","['A total of 380 men were evaluated (64% with\xa0spacer\xa0and 36% without) with QOL data being available for 199 men beyond 24 months of follow-up (median: 39.5 months, range: 31-71.4 mo', 'men receiving radiotherapy for prostate cancer', 'patients with\xa0or without hydrogel spacer', '215 patients']","['radiation with or without hydrogel spacer with a QOL end-point', 'Radiotherapy']","['loose stools', 'Expanded Prostate Cancer Index Composite (EPIC', 'MIDx2', 'frequency of bowel movements', 'bowel QOL', 'spacer', 'urgency with bowel movements', 'average long-term bowel QOL']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4319693', 'cui_str': '380'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0221874', 'cui_str': 'Spacer'}, {'cui': 'C4759659', 'cui_str': 'With quality'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0063083', 'cui_str': 'Hydrogel'}, {'cui': 'C4709308', 'cui_str': '215'}]","[{'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0063083', 'cui_str': 'Hydrogel'}, {'cui': 'C0221874', 'cui_str': 'Spacer'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}]","[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0205229', 'cui_str': 'Expanding'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0426642', 'cui_str': 'Frequency of bowel action'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0221874', 'cui_str': 'Spacer'}, {'cui': 'C0439609', 'cui_str': 'Urgent'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}]",380.0,0.0484881,"The use of spacer was associated with less urgency with bowel movements (p=0.002) and fewer loose stools (p=0.009) as well as less bother with urgency (0.007) and frequency of bowel movements (p=0.009). ","[{'ForeName': 'Zachary A', 'Initials': 'ZA', 'LastName': 'Seymour', 'Affiliation': 'Department of Radiation Oncology, Beaumont Health, Dearborn, MI, USA.'}, {'ForeName': 'Daniel A', 'Initials': 'DA', 'LastName': 'Hamstra', 'Affiliation': 'Department of Radiation Oncology, Beaumont Health, Dearborn, MI, USA.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Daignault-Newton', 'Affiliation': 'Department of Radiation Oncology, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Bosch', 'Affiliation': 'Department of Radiation Oncology and School of Medicine, Washington University, St. Louis, MO, USA.'}, {'ForeName': 'Jeffery', 'Initials': 'J', 'LastName': 'Michalski', 'Affiliation': 'Department of Radiation Oncology and School of Medicine, Washington University, St. Louis, MO, USA.'}, {'ForeName': 'Hiram A', 'Initials': 'HA', 'LastName': 'Gay', 'Affiliation': 'Department of Radiation Oncology and School of Medicine, Washington University, St. Louis, MO, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Pinkawa', 'Affiliation': 'Department of Radiotherapy, RWTH Aachen University, Aachen, Germany.'}]",BJU international,['10.1111/bju.15097'] 128,30779530,Adjunctive Intermittent Pneumatic Compression for Venous Thromboprophylaxis.,"BACKGROUND Whether adjunctive intermittent pneumatic compression in critically ill patients receiving pharmacologic thromboprophylaxis would result in a lower incidence of deep-vein thrombosis than pharmacologic thromboprophylaxis alone is uncertain. METHODS We randomly assigned patients who were considered adults according to the local standards at the participating sites (≥14, ≥16, or ≥18 years of age) within 48 hours after admission to an intensive care unit (ICU) to receive either intermittent pneumatic compression for at least 18 hours each day in addition to pharmacologic thromboprophylaxis with unfractionated or low-molecular-weight heparin (pneumatic compression group) or pharmacologic thromboprophylaxis alone (control group). The primary outcome was incident (i.e., new) proximal lower-limb deep-vein thrombosis, as detected on twice-weekly lower-limb ultrasonography after the third calendar day since randomization until ICU discharge, death, attainment of full mobility, or trial day 28, whichever occurred first. RESULTS A total of 2003 patients underwent randomization - 991 were assigned to the pneumatic compression group and 1012 to the control group. Intermittent pneumatic compression was applied for a median of 22 hours (interquartile range, 21 to 23) daily for a median of 7 days (interquartile range, 4 to 13). The primary outcome occurred in 37 of 957 patients (3.9%) in the pneumatic compression group and in 41 of 985 patients (4.2%) in the control group (relative risk, 0.93; 95% confidence interval [CI], 0.60 to 1.44; P = 0.74). Venous thromboembolism (pulmonary embolism or any lower-limb deep-vein thrombosis) occurred in 103 of 991 patients (10.4%) in the pneumatic compression group and in 95 of 1012 patients (9.4%) in the control group (relative risk, 1.11; 95% CI, 0.85 to 1.44), and death from any cause at 90 days occurred in 258 of 990 patients (26.1%) and 270 of 1011 patients (26.7%), respectively (relative risk, 0.98; 95% CI, 0.84 to 1.13). CONCLUSIONS Among critically ill patients who were receiving pharmacologic thromboprophylaxis, adjunctive intermittent pneumatic compression did not result in a significantly lower incidence of proximal lower-limb deep-vein thrombosis than pharmacologic thromboprophylaxis alone. (Funded by King Abdulaziz City for Science and Technology and King Abdullah International Medical Research Center; PREVENT ClinicalTrials.gov number, NCT02040103; Current Controlled Trials number, ISRCTN44653506.).",2019,"Venous thromboembolism (pulmonary embolism or any lower-limb deep-vein thrombosis) occurred in 103 of 991 patients (10.4%) in the pneumatic compression group and in 95 of 1012 patients (9.4%) in the control group (relative risk, 1.11; 95% CI, 0.85 to 1.44), and death from any cause at 90 days occurred in 258 of 990 patients (26.1%) and 270 of 1011 patients (26.7%), respectively (relative risk, 0.98; 95% CI, 0.84 to 1.13). ","['We randomly assigned patients who were considered adults according to the local standards at the participating sites (≥14, ≥16, or ≥18 years of age) within 48 hours after admission to an intensive care unit (ICU) to receive either', 'critically ill patients receiving', '2003 patients underwent randomization - 991', 'critically ill patients who were receiving']","['adjunctive intermittent pneumatic compression', 'pneumatic compression', 'Intermittent pneumatic compression', 'intermittent pneumatic compression for at least 18 hours each day in addition to pharmacologic thromboprophylaxis with unfractionated or low-molecular-weight heparin (pneumatic compression group) or pharmacologic thromboprophylaxis alone (control group', 'pharmacologic thromboprophylaxis', 'Adjunctive Intermittent Pneumatic Compression', 'pharmacologic thromboprophylaxis, adjunctive intermittent pneumatic compression']","['Venous thromboembolism (pulmonary embolism or any lower-limb deep-vein thrombosis', 'incident (i.e., new) proximal lower-limb deep-vein thrombosis, as detected on twice-weekly lower-limb ultrasonography after the third calendar day since randomization until ICU discharge, death, attainment of full mobility, or trial day 28, whichever occurred first', 'incidence of proximal lower-limb deep-vein thrombosis', 'death']","[{'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0043237', 'cui_str': 'WHO'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332285', 'cui_str': 'In (attribute)'}, {'cui': 'C0439586', 'cui_str': '48 hours (qualifier value)'}, {'cui': 'C0231290', 'cui_str': 'Status post (contextual qualifier) (qualifier value)'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0010340', 'cui_str': 'Critically Ill'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}]","[{'cui': 'C0205267', 'cui_str': 'Intermittent (qualifier value)'}, {'cui': 'C0332459', 'cui_str': 'Compression (morphologic abnormality)'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0205464', 'cui_str': 'Pharmacologic (qualifier value)'}, {'cui': 'C0019139', 'cui_str': 'LMWH'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C1861172', 'cui_str': 'Venous Thromboembolism'}, {'cui': 'C0034065', 'cui_str': 'Pulmonary Embolism'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0149871', 'cui_str': 'Deep Vein Thrombosis'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0205107', 'cui_str': 'Proximal (qualifier value)'}, {'cui': 'C0442726', 'cui_str': 'Detected (qualifier value)'}, {'cui': 'C0556985', 'cui_str': 'Two times a week'}, {'cui': 'C0041618', 'cui_str': 'Echotomography'}, {'cui': 'C1516147', 'cui_str': 'Calendar'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}]",2003.0,0.255245,"Venous thromboembolism (pulmonary embolism or any lower-limb deep-vein thrombosis) occurred in 103 of 991 patients (10.4%) in the pneumatic compression group and in 95 of 1012 patients (9.4%) in the control group (relative risk, 1.11; 95% CI, 0.85 to 1.44), and death from any cause at 90 days occurred in 258 of 990 patients (26.1%) and 270 of 1011 patients (26.7%), respectively (relative risk, 0.98; 95% CI, 0.84 to 1.13). ","[{'ForeName': 'Yaseen M', 'Initials': 'YM', 'LastName': 'Arabi', 'Affiliation': ""From the College of Medicine, King Saud Bin Abdulaziz University for Health Sciences (Y.M.A., S.J.A., S.A.I.A., A.A.-D.), the Departments of Intensive Care (Y.M.A., S.J.A., S.A.I.A., A.A.-D.) and Emergency Medicine, (S.J.A.), Ministry of National Guard Health Affairs, Military Medical Services, Ministry of Defense (Y. Mandourah), the Department of Intensive Care Services, Prince Sultan Military Medical City (G.A.A.), the Department of Pulmonary and Critical Care Medicine, King Fahad Medical City (M.A., H.L.), Critical Care Medicine Department, King Faisal Specialist Hospital and Research Center (H.H.), and the Department of Biostatistics and Bioinformatics (J.J.) and Research Office (L.Y.A.), King Abdullah International Medical Research Center (Y.M.A., S.J.A., S.A.I.A., A.A.-D.), Riyadh, College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, and the Intensive Care Department, Ministry of National Guard Health Affairs (F.A.-H.), and Critical Care Section, Department of Medicine, King Faisal Specialist Hospital and Research Center (I.K.), Jeddah, the Department of Emergency and Critical Care Medicine, College of Medicine, King Fahd Hospital of the University, Imam Abdulrahman Bin Faisal University (M.S.A.), Dammam, the Department of Critical Care Medicine, King Khalid University, Asir Central Hospital (A.A.B.), Abha, and King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, and the Intensive Care Division, Department of Medicine, King Abdulaziz Hospital (A.A.A.), Al Ahsa - all in Saudi Arabia; St. Michael's Hospital, Li Ka Shing Knowledge Institute (K.E.A.B.), the Department of Medicine, Sinai Health System (S.M.), and Interdepartmental Division of Critical Care Medicine, University of Toronto (K.E.A.B, S.M.) - all in Toronto; the George Institute for Global Health (S.F.), the Department of Intensive Care Medicine, Centre for Applied Medical Research, St. Vincent's Hospital (H.B.), and the University of New South Wales, Sydney (S.F., H.B.), and Intensive Care Department, Gosford Hospital, Gosford, NSW (A.G.) - all in Australia; and the Department of Anesthesiology and Critical Care, King George's Medical University, Lucknow (Z.A.), and Institute of Critical Care and Anesthesiology, Medanta-The Medicity, Gurgaon (Y. Mehta) - both in India.""}, {'ForeName': 'Fahad', 'Initials': 'F', 'LastName': 'Al-Hameed', 'Affiliation': ""From the College of Medicine, King Saud Bin Abdulaziz University for Health Sciences (Y.M.A., S.J.A., S.A.I.A., A.A.-D.), the Departments of Intensive Care (Y.M.A., S.J.A., S.A.I.A., A.A.-D.) and Emergency Medicine, (S.J.A.), Ministry of National Guard Health Affairs, Military Medical Services, Ministry of Defense (Y. Mandourah), the Department of Intensive Care Services, Prince Sultan Military Medical City (G.A.A.), the Department of Pulmonary and Critical Care Medicine, King Fahad Medical City (M.A., H.L.), Critical Care Medicine Department, King Faisal Specialist Hospital and Research Center (H.H.), and the Department of Biostatistics and Bioinformatics (J.J.) and Research Office (L.Y.A.), King Abdullah International Medical Research Center (Y.M.A., S.J.A., S.A.I.A., A.A.-D.), Riyadh, College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, and the Intensive Care Department, Ministry of National Guard Health Affairs (F.A.-H.), and Critical Care Section, Department of Medicine, King Faisal Specialist Hospital and Research Center (I.K.), Jeddah, the Department of Emergency and Critical Care Medicine, College of Medicine, King Fahd Hospital of the University, Imam Abdulrahman Bin Faisal University (M.S.A.), Dammam, the Department of Critical Care Medicine, King Khalid University, Asir Central Hospital (A.A.B.), Abha, and King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, and the Intensive Care Division, Department of Medicine, King Abdulaziz Hospital (A.A.A.), Al Ahsa - all in Saudi Arabia; St. Michael's Hospital, Li Ka Shing Knowledge Institute (K.E.A.B.), the Department of Medicine, Sinai Health System (S.M.), and Interdepartmental Division of Critical Care Medicine, University of Toronto (K.E.A.B, S.M.) - all in Toronto; the George Institute for Global Health (S.F.), the Department of Intensive Care Medicine, Centre for Applied Medical Research, St. Vincent's Hospital (H.B.), and the University of New South Wales, Sydney (S.F., H.B.), and Intensive Care Department, Gosford Hospital, Gosford, NSW (A.G.) - all in Australia; and the Department of Anesthesiology and Critical Care, King George's Medical University, Lucknow (Z.A.), and Institute of Critical Care and Anesthesiology, Medanta-The Medicity, Gurgaon (Y. Mehta) - both in India.""}, {'ForeName': 'Karen E A', 'Initials': 'KEA', 'LastName': 'Burns', 'Affiliation': ""From the College of Medicine, King Saud Bin Abdulaziz University for Health Sciences (Y.M.A., S.J.A., S.A.I.A., A.A.-D.), the Departments of Intensive Care (Y.M.A., S.J.A., S.A.I.A., A.A.-D.) and Emergency Medicine, (S.J.A.), Ministry of National Guard Health Affairs, Military Medical Services, Ministry of Defense (Y. Mandourah), the Department of Intensive Care Services, Prince Sultan Military Medical City (G.A.A.), the Department of Pulmonary and Critical Care Medicine, King Fahad Medical City (M.A., H.L.), Critical Care Medicine Department, King Faisal Specialist Hospital and Research Center (H.H.), and the Department of Biostatistics and Bioinformatics (J.J.) and Research Office (L.Y.A.), King Abdullah International Medical Research Center (Y.M.A., S.J.A., S.A.I.A., A.A.-D.), Riyadh, College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, and the Intensive Care Department, Ministry of National Guard Health Affairs (F.A.-H.), and Critical Care Section, Department of Medicine, King Faisal Specialist Hospital and Research Center (I.K.), Jeddah, the Department of Emergency and Critical Care Medicine, College of Medicine, King Fahd Hospital of the University, Imam Abdulrahman Bin Faisal University (M.S.A.), Dammam, the Department of Critical Care Medicine, King Khalid University, Asir Central Hospital (A.A.B.), Abha, and King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, and the Intensive Care Division, Department of Medicine, King Abdulaziz Hospital (A.A.A.), Al Ahsa - all in Saudi Arabia; St. Michael's Hospital, Li Ka Shing Knowledge Institute (K.E.A.B.), the Department of Medicine, Sinai Health System (S.M.), and Interdepartmental Division of Critical Care Medicine, University of Toronto (K.E.A.B, S.M.) - all in Toronto; the George Institute for Global Health (S.F.), the Department of Intensive Care Medicine, Centre for Applied Medical Research, St. Vincent's Hospital (H.B.), and the University of New South Wales, Sydney (S.F., H.B.), and Intensive Care Department, Gosford Hospital, Gosford, NSW (A.G.) - all in Australia; and the Department of Anesthesiology and Critical Care, King George's Medical University, Lucknow (Z.A.), and Institute of Critical Care and Anesthesiology, Medanta-The Medicity, Gurgaon (Y. Mehta) - both in India.""}, {'ForeName': 'Sangeeta', 'Initials': 'S', 'LastName': 'Mehta', 'Affiliation': ""From the College of Medicine, King Saud Bin Abdulaziz University for Health Sciences (Y.M.A., S.J.A., S.A.I.A., A.A.-D.), the Departments of Intensive Care (Y.M.A., S.J.A., S.A.I.A., A.A.-D.) and Emergency Medicine, (S.J.A.), Ministry of National Guard Health Affairs, Military Medical Services, Ministry of Defense (Y. Mandourah), the Department of Intensive Care Services, Prince Sultan Military Medical City (G.A.A.), the Department of Pulmonary and Critical Care Medicine, King Fahad Medical City (M.A., H.L.), Critical Care Medicine Department, King Faisal Specialist Hospital and Research Center (H.H.), and the Department of Biostatistics and Bioinformatics (J.J.) and Research Office (L.Y.A.), King Abdullah International Medical Research Center (Y.M.A., S.J.A., S.A.I.A., A.A.-D.), Riyadh, College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, and the Intensive Care Department, Ministry of National Guard Health Affairs (F.A.-H.), and Critical Care Section, Department of Medicine, King Faisal Specialist Hospital and Research Center (I.K.), Jeddah, the Department of Emergency and Critical Care Medicine, College of Medicine, King Fahd Hospital of the University, Imam Abdulrahman Bin Faisal University (M.S.A.), Dammam, the Department of Critical Care Medicine, King Khalid University, Asir Central Hospital (A.A.B.), Abha, and King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, and the Intensive Care Division, Department of Medicine, King Abdulaziz Hospital (A.A.A.), Al Ahsa - all in Saudi Arabia; St. Michael's Hospital, Li Ka Shing Knowledge Institute (K.E.A.B.), the Department of Medicine, Sinai Health System (S.M.), and Interdepartmental Division of Critical Care Medicine, University of Toronto (K.E.A.B, S.M.) - all in Toronto; the George Institute for Global Health (S.F.), the Department of Intensive Care Medicine, Centre for Applied Medical Research, St. Vincent's Hospital (H.B.), and the University of New South Wales, Sydney (S.F., H.B.), and Intensive Care Department, Gosford Hospital, Gosford, NSW (A.G.) - all in Australia; and the Department of Anesthesiology and Critical Care, King George's Medical University, Lucknow (Z.A.), and Institute of Critical Care and Anesthesiology, Medanta-The Medicity, Gurgaon (Y. Mehta) - both in India.""}, {'ForeName': 'Sami J', 'Initials': 'SJ', 'LastName': 'Alsolamy', 'Affiliation': ""From the College of Medicine, King Saud Bin Abdulaziz University for Health Sciences (Y.M.A., S.J.A., S.A.I.A., A.A.-D.), the Departments of Intensive Care (Y.M.A., S.J.A., S.A.I.A., A.A.-D.) and Emergency Medicine, (S.J.A.), Ministry of National Guard Health Affairs, Military Medical Services, Ministry of Defense (Y. Mandourah), the Department of Intensive Care Services, Prince Sultan Military Medical City (G.A.A.), the Department of Pulmonary and Critical Care Medicine, King Fahad Medical City (M.A., H.L.), Critical Care Medicine Department, King Faisal Specialist Hospital and Research Center (H.H.), and the Department of Biostatistics and Bioinformatics (J.J.) and Research Office (L.Y.A.), King Abdullah International Medical Research Center (Y.M.A., S.J.A., S.A.I.A., A.A.-D.), Riyadh, College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, and the Intensive Care Department, Ministry of National Guard Health Affairs (F.A.-H.), and Critical Care Section, Department of Medicine, King Faisal Specialist Hospital and Research Center (I.K.), Jeddah, the Department of Emergency and Critical Care Medicine, College of Medicine, King Fahd Hospital of the University, Imam Abdulrahman Bin Faisal University (M.S.A.), Dammam, the Department of Critical Care Medicine, King Khalid University, Asir Central Hospital (A.A.B.), Abha, and King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, and the Intensive Care Division, Department of Medicine, King Abdulaziz Hospital (A.A.A.), Al Ahsa - all in Saudi Arabia; St. Michael's Hospital, Li Ka Shing Knowledge Institute (K.E.A.B.), the Department of Medicine, Sinai Health System (S.M.), and Interdepartmental Division of Critical Care Medicine, University of Toronto (K.E.A.B, S.M.) - all in Toronto; the George Institute for Global Health (S.F.), the Department of Intensive Care Medicine, Centre for Applied Medical Research, St. Vincent's Hospital (H.B.), and the University of New South Wales, Sydney (S.F., H.B.), and Intensive Care Department, Gosford Hospital, Gosford, NSW (A.G.) - all in Australia; and the Department of Anesthesiology and Critical Care, King George's Medical University, Lucknow (Z.A.), and Institute of Critical Care and Anesthesiology, Medanta-The Medicity, Gurgaon (Y. Mehta) - both in India.""}, {'ForeName': 'Mohammed S', 'Initials': 'MS', 'LastName': 'Alshahrani', 'Affiliation': ""From the College of Medicine, King Saud Bin Abdulaziz University for Health Sciences (Y.M.A., S.J.A., S.A.I.A., A.A.-D.), the Departments of Intensive Care (Y.M.A., S.J.A., S.A.I.A., A.A.-D.) and Emergency Medicine, (S.J.A.), Ministry of National Guard Health Affairs, Military Medical Services, Ministry of Defense (Y. Mandourah), the Department of Intensive Care Services, Prince Sultan Military Medical City (G.A.A.), the Department of Pulmonary and Critical Care Medicine, King Fahad Medical City (M.A., H.L.), Critical Care Medicine Department, King Faisal Specialist Hospital and Research Center (H.H.), and the Department of Biostatistics and Bioinformatics (J.J.) and Research Office (L.Y.A.), King Abdullah International Medical Research Center (Y.M.A., S.J.A., S.A.I.A., A.A.-D.), Riyadh, College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, and the Intensive Care Department, Ministry of National Guard Health Affairs (F.A.-H.), and Critical Care Section, Department of Medicine, King Faisal Specialist Hospital and Research Center (I.K.), Jeddah, the Department of Emergency and Critical Care Medicine, College of Medicine, King Fahd Hospital of the University, Imam Abdulrahman Bin Faisal University (M.S.A.), Dammam, the Department of Critical Care Medicine, King Khalid University, Asir Central Hospital (A.A.B.), Abha, and King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, and the Intensive Care Division, Department of Medicine, King Abdulaziz Hospital (A.A.A.), Al Ahsa - all in Saudi Arabia; St. Michael's Hospital, Li Ka Shing Knowledge Institute (K.E.A.B.), the Department of Medicine, Sinai Health System (S.M.), and Interdepartmental Division of Critical Care Medicine, University of Toronto (K.E.A.B, S.M.) - all in Toronto; the George Institute for Global Health (S.F.), the Department of Intensive Care Medicine, Centre for Applied Medical Research, St. Vincent's Hospital (H.B.), and the University of New South Wales, Sydney (S.F., H.B.), and Intensive Care Department, Gosford Hospital, Gosford, NSW (A.G.) - all in Australia; and the Department of Anesthesiology and Critical Care, King George's Medical University, Lucknow (Z.A.), and Institute of Critical Care and Anesthesiology, Medanta-The Medicity, Gurgaon (Y. Mehta) - both in India.""}, {'ForeName': 'Yasser', 'Initials': 'Y', 'LastName': 'Mandourah', 'Affiliation': ""From the College of Medicine, King Saud Bin Abdulaziz University for Health Sciences (Y.M.A., S.J.A., S.A.I.A., A.A.-D.), the Departments of Intensive Care (Y.M.A., S.J.A., S.A.I.A., A.A.-D.) and Emergency Medicine, (S.J.A.), Ministry of National Guard Health Affairs, Military Medical Services, Ministry of Defense (Y. Mandourah), the Department of Intensive Care Services, Prince Sultan Military Medical City (G.A.A.), the Department of Pulmonary and Critical Care Medicine, King Fahad Medical City (M.A., H.L.), Critical Care Medicine Department, King Faisal Specialist Hospital and Research Center (H.H.), and the Department of Biostatistics and Bioinformatics (J.J.) and Research Office (L.Y.A.), King Abdullah International Medical Research Center (Y.M.A., S.J.A., S.A.I.A., A.A.-D.), Riyadh, College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, and the Intensive Care Department, Ministry of National Guard Health Affairs (F.A.-H.), and Critical Care Section, Department of Medicine, King Faisal Specialist Hospital and Research Center (I.K.), Jeddah, the Department of Emergency and Critical Care Medicine, College of Medicine, King Fahd Hospital of the University, Imam Abdulrahman Bin Faisal University (M.S.A.), Dammam, the Department of Critical Care Medicine, King Khalid University, Asir Central Hospital (A.A.B.), Abha, and King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, and the Intensive Care Division, Department of Medicine, King Abdulaziz Hospital (A.A.A.), Al Ahsa - all in Saudi Arabia; St. Michael's Hospital, Li Ka Shing Knowledge Institute (K.E.A.B.), the Department of Medicine, Sinai Health System (S.M.), and Interdepartmental Division of Critical Care Medicine, University of Toronto (K.E.A.B, S.M.) - all in Toronto; the George Institute for Global Health (S.F.), the Department of Intensive Care Medicine, Centre for Applied Medical Research, St. Vincent's Hospital (H.B.), and the University of New South Wales, Sydney (S.F., H.B.), and Intensive Care Department, Gosford Hospital, Gosford, NSW (A.G.) - all in Australia; and the Department of Anesthesiology and Critical Care, King George's Medical University, Lucknow (Z.A.), and Institute of Critical Care and Anesthesiology, Medanta-The Medicity, Gurgaon (Y. Mehta) - both in India.""}, {'ForeName': 'Ghaleb A', 'Initials': 'GA', 'LastName': 'Almekhlafi', 'Affiliation': ""From the College of Medicine, King Saud Bin Abdulaziz University for Health Sciences (Y.M.A., S.J.A., S.A.I.A., A.A.-D.), the Departments of Intensive Care (Y.M.A., S.J.A., S.A.I.A., A.A.-D.) and Emergency Medicine, (S.J.A.), Ministry of National Guard Health Affairs, Military Medical Services, Ministry of Defense (Y. Mandourah), the Department of Intensive Care Services, Prince Sultan Military Medical City (G.A.A.), the Department of Pulmonary and Critical Care Medicine, King Fahad Medical City (M.A., H.L.), Critical Care Medicine Department, King Faisal Specialist Hospital and Research Center (H.H.), and the Department of Biostatistics and Bioinformatics (J.J.) and Research Office (L.Y.A.), King Abdullah International Medical Research Center (Y.M.A., S.J.A., S.A.I.A., A.A.-D.), Riyadh, College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, and the Intensive Care Department, Ministry of National Guard Health Affairs (F.A.-H.), and Critical Care Section, Department of Medicine, King Faisal Specialist Hospital and Research Center (I.K.), Jeddah, the Department of Emergency and Critical Care Medicine, College of Medicine, King Fahd Hospital of the University, Imam Abdulrahman Bin Faisal University (M.S.A.), Dammam, the Department of Critical Care Medicine, King Khalid University, Asir Central Hospital (A.A.B.), Abha, and King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, and the Intensive Care Division, Department of Medicine, King Abdulaziz Hospital (A.A.A.), Al Ahsa - all in Saudi Arabia; St. Michael's Hospital, Li Ka Shing Knowledge Institute (K.E.A.B.), the Department of Medicine, Sinai Health System (S.M.), and Interdepartmental Division of Critical Care Medicine, University of Toronto (K.E.A.B, S.M.) - all in Toronto; the George Institute for Global Health (S.F.), the Department of Intensive Care Medicine, Centre for Applied Medical Research, St. Vincent's Hospital (H.B.), and the University of New South Wales, Sydney (S.F., H.B.), and Intensive Care Department, Gosford Hospital, Gosford, NSW (A.G.) - all in Australia; and the Department of Anesthesiology and Critical Care, King George's Medical University, Lucknow (Z.A.), and Institute of Critical Care and Anesthesiology, Medanta-The Medicity, Gurgaon (Y. Mehta) - both in India.""}, {'ForeName': 'Mohammed', 'Initials': 'M', 'LastName': 'Almaani', 'Affiliation': ""From the College of Medicine, King Saud Bin Abdulaziz University for Health Sciences (Y.M.A., S.J.A., S.A.I.A., A.A.-D.), the Departments of Intensive Care (Y.M.A., S.J.A., S.A.I.A., A.A.-D.) and Emergency Medicine, (S.J.A.), Ministry of National Guard Health Affairs, Military Medical Services, Ministry of Defense (Y. Mandourah), the Department of Intensive Care Services, Prince Sultan Military Medical City (G.A.A.), the Department of Pulmonary and Critical Care Medicine, King Fahad Medical City (M.A., H.L.), Critical Care Medicine Department, King Faisal Specialist Hospital and Research Center (H.H.), and the Department of Biostatistics and Bioinformatics (J.J.) and Research Office (L.Y.A.), King Abdullah International Medical Research Center (Y.M.A., S.J.A., S.A.I.A., A.A.-D.), Riyadh, College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, and the Intensive Care Department, Ministry of National Guard Health Affairs (F.A.-H.), and Critical Care Section, Department of Medicine, King Faisal Specialist Hospital and Research Center (I.K.), Jeddah, the Department of Emergency and Critical Care Medicine, College of Medicine, King Fahd Hospital of the University, Imam Abdulrahman Bin Faisal University (M.S.A.), Dammam, the Department of Critical Care Medicine, King Khalid University, Asir Central Hospital (A.A.B.), Abha, and King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, and the Intensive Care Division, Department of Medicine, King Abdulaziz Hospital (A.A.A.), Al Ahsa - all in Saudi Arabia; St. Michael's Hospital, Li Ka Shing Knowledge Institute (K.E.A.B.), the Department of Medicine, Sinai Health System (S.M.), and Interdepartmental Division of Critical Care Medicine, University of Toronto (K.E.A.B, S.M.) - all in Toronto; the George Institute for Global Health (S.F.), the Department of Intensive Care Medicine, Centre for Applied Medical Research, St. Vincent's Hospital (H.B.), and the University of New South Wales, Sydney (S.F., H.B.), and Intensive Care Department, Gosford Hospital, Gosford, NSW (A.G.) - all in Australia; and the Department of Anesthesiology and Critical Care, King George's Medical University, Lucknow (Z.A.), and Institute of Critical Care and Anesthesiology, Medanta-The Medicity, Gurgaon (Y. Mehta) - both in India.""}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Al Bshabshe', 'Affiliation': ""From the College of Medicine, King Saud Bin Abdulaziz University for Health Sciences (Y.M.A., S.J.A., S.A.I.A., A.A.-D.), the Departments of Intensive Care (Y.M.A., S.J.A., S.A.I.A., A.A.-D.) and Emergency Medicine, (S.J.A.), Ministry of National Guard Health Affairs, Military Medical Services, Ministry of Defense (Y. Mandourah), the Department of Intensive Care Services, Prince Sultan Military Medical City (G.A.A.), the Department of Pulmonary and Critical Care Medicine, King Fahad Medical City (M.A., H.L.), Critical Care Medicine Department, King Faisal Specialist Hospital and Research Center (H.H.), and the Department of Biostatistics and Bioinformatics (J.J.) and Research Office (L.Y.A.), King Abdullah International Medical Research Center (Y.M.A., S.J.A., S.A.I.A., A.A.-D.), Riyadh, College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, and the Intensive Care Department, Ministry of National Guard Health Affairs (F.A.-H.), and Critical Care Section, Department of Medicine, King Faisal Specialist Hospital and Research Center (I.K.), Jeddah, the Department of Emergency and Critical Care Medicine, College of Medicine, King Fahd Hospital of the University, Imam Abdulrahman Bin Faisal University (M.S.A.), Dammam, the Department of Critical Care Medicine, King Khalid University, Asir Central Hospital (A.A.B.), Abha, and King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, and the Intensive Care Division, Department of Medicine, King Abdulaziz Hospital (A.A.A.), Al Ahsa - all in Saudi Arabia; St. Michael's Hospital, Li Ka Shing Knowledge Institute (K.E.A.B.), the Department of Medicine, Sinai Health System (S.M.), and Interdepartmental Division of Critical Care Medicine, University of Toronto (K.E.A.B, S.M.) - all in Toronto; the George Institute for Global Health (S.F.), the Department of Intensive Care Medicine, Centre for Applied Medical Research, St. Vincent's Hospital (H.B.), and the University of New South Wales, Sydney (S.F., H.B.), and Intensive Care Department, Gosford Hospital, Gosford, NSW (A.G.) - all in Australia; and the Department of Anesthesiology and Critical Care, King George's Medical University, Lucknow (Z.A.), and Institute of Critical Care and Anesthesiology, Medanta-The Medicity, Gurgaon (Y. Mehta) - both in India.""}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Finfer', 'Affiliation': ""From the College of Medicine, King Saud Bin Abdulaziz University for Health Sciences (Y.M.A., S.J.A., S.A.I.A., A.A.-D.), the Departments of Intensive Care (Y.M.A., S.J.A., S.A.I.A., A.A.-D.) and Emergency Medicine, (S.J.A.), Ministry of National Guard Health Affairs, Military Medical Services, Ministry of Defense (Y. Mandourah), the Department of Intensive Care Services, Prince Sultan Military Medical City (G.A.A.), the Department of Pulmonary and Critical Care Medicine, King Fahad Medical City (M.A., H.L.), Critical Care Medicine Department, King Faisal Specialist Hospital and Research Center (H.H.), and the Department of Biostatistics and Bioinformatics (J.J.) and Research Office (L.Y.A.), King Abdullah International Medical Research Center (Y.M.A., S.J.A., S.A.I.A., A.A.-D.), Riyadh, College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, and the Intensive Care Department, Ministry of National Guard Health Affairs (F.A.-H.), and Critical Care Section, Department of Medicine, King Faisal Specialist Hospital and Research Center (I.K.), Jeddah, the Department of Emergency and Critical Care Medicine, College of Medicine, King Fahd Hospital of the University, Imam Abdulrahman Bin Faisal University (M.S.A.), Dammam, the Department of Critical Care Medicine, King Khalid University, Asir Central Hospital (A.A.B.), Abha, and King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, and the Intensive Care Division, Department of Medicine, King Abdulaziz Hospital (A.A.A.), Al Ahsa - all in Saudi Arabia; St. Michael's Hospital, Li Ka Shing Knowledge Institute (K.E.A.B.), the Department of Medicine, Sinai Health System (S.M.), and Interdepartmental Division of Critical Care Medicine, University of Toronto (K.E.A.B, S.M.) - all in Toronto; the George Institute for Global Health (S.F.), the Department of Intensive Care Medicine, Centre for Applied Medical Research, St. Vincent's Hospital (H.B.), and the University of New South Wales, Sydney (S.F., H.B.), and Intensive Care Department, Gosford Hospital, Gosford, NSW (A.G.) - all in Australia; and the Department of Anesthesiology and Critical Care, King George's Medical University, Lucknow (Z.A.), and Institute of Critical Care and Anesthesiology, Medanta-The Medicity, Gurgaon (Y. Mehta) - both in India.""}, {'ForeName': 'Zia', 'Initials': 'Z', 'LastName': 'Arshad', 'Affiliation': ""From the College of Medicine, King Saud Bin Abdulaziz University for Health Sciences (Y.M.A., S.J.A., S.A.I.A., A.A.-D.), the Departments of Intensive Care (Y.M.A., S.J.A., S.A.I.A., A.A.-D.) and Emergency Medicine, (S.J.A.), Ministry of National Guard Health Affairs, Military Medical Services, Ministry of Defense (Y. Mandourah), the Department of Intensive Care Services, Prince Sultan Military Medical City (G.A.A.), the Department of Pulmonary and Critical Care Medicine, King Fahad Medical City (M.A., H.L.), Critical Care Medicine Department, King Faisal Specialist Hospital and Research Center (H.H.), and the Department of Biostatistics and Bioinformatics (J.J.) and Research Office (L.Y.A.), King Abdullah International Medical Research Center (Y.M.A., S.J.A., S.A.I.A., A.A.-D.), Riyadh, College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, and the Intensive Care Department, Ministry of National Guard Health Affairs (F.A.-H.), and Critical Care Section, Department of Medicine, King Faisal Specialist Hospital and Research Center (I.K.), Jeddah, the Department of Emergency and Critical Care Medicine, College of Medicine, King Fahd Hospital of the University, Imam Abdulrahman Bin Faisal University (M.S.A.), Dammam, the Department of Critical Care Medicine, King Khalid University, Asir Central Hospital (A.A.B.), Abha, and King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, and the Intensive Care Division, Department of Medicine, King Abdulaziz Hospital (A.A.A.), Al Ahsa - all in Saudi Arabia; St. Michael's Hospital, Li Ka Shing Knowledge Institute (K.E.A.B.), the Department of Medicine, Sinai Health System (S.M.), and Interdepartmental Division of Critical Care Medicine, University of Toronto (K.E.A.B, S.M.) - all in Toronto; the George Institute for Global Health (S.F.), the Department of Intensive Care Medicine, Centre for Applied Medical Research, St. Vincent's Hospital (H.B.), and the University of New South Wales, Sydney (S.F., H.B.), and Intensive Care Department, Gosford Hospital, Gosford, NSW (A.G.) - all in Australia; and the Department of Anesthesiology and Critical Care, King George's Medical University, Lucknow (Z.A.), and Institute of Critical Care and Anesthesiology, Medanta-The Medicity, Gurgaon (Y. Mehta) - both in India.""}, {'ForeName': 'Imran', 'Initials': 'I', 'LastName': 'Khalid', 'Affiliation': ""From the College of Medicine, King Saud Bin Abdulaziz University for Health Sciences (Y.M.A., S.J.A., S.A.I.A., A.A.-D.), the Departments of Intensive Care (Y.M.A., S.J.A., S.A.I.A., A.A.-D.) and Emergency Medicine, (S.J.A.), Ministry of National Guard Health Affairs, Military Medical Services, Ministry of Defense (Y. Mandourah), the Department of Intensive Care Services, Prince Sultan Military Medical City (G.A.A.), the Department of Pulmonary and Critical Care Medicine, King Fahad Medical City (M.A., H.L.), Critical Care Medicine Department, King Faisal Specialist Hospital and Research Center (H.H.), and the Department of Biostatistics and Bioinformatics (J.J.) and Research Office (L.Y.A.), King Abdullah International Medical Research Center (Y.M.A., S.J.A., S.A.I.A., A.A.-D.), Riyadh, College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, and the Intensive Care Department, Ministry of National Guard Health Affairs (F.A.-H.), and Critical Care Section, Department of Medicine, King Faisal Specialist Hospital and Research Center (I.K.), Jeddah, the Department of Emergency and Critical Care Medicine, College of Medicine, King Fahd Hospital of the University, Imam Abdulrahman Bin Faisal University (M.S.A.), Dammam, the Department of Critical Care Medicine, King Khalid University, Asir Central Hospital (A.A.B.), Abha, and King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, and the Intensive Care Division, Department of Medicine, King Abdulaziz Hospital (A.A.A.), Al Ahsa - all in Saudi Arabia; St. Michael's Hospital, Li Ka Shing Knowledge Institute (K.E.A.B.), the Department of Medicine, Sinai Health System (S.M.), and Interdepartmental Division of Critical Care Medicine, University of Toronto (K.E.A.B, S.M.) - all in Toronto; the George Institute for Global Health (S.F.), the Department of Intensive Care Medicine, Centre for Applied Medical Research, St. Vincent's Hospital (H.B.), and the University of New South Wales, Sydney (S.F., H.B.), and Intensive Care Department, Gosford Hospital, Gosford, NSW (A.G.) - all in Australia; and the Department of Anesthesiology and Critical Care, King George's Medical University, Lucknow (Z.A.), and Institute of Critical Care and Anesthesiology, Medanta-The Medicity, Gurgaon (Y. Mehta) - both in India.""}, {'ForeName': 'Yatin', 'Initials': 'Y', 'LastName': 'Mehta', 'Affiliation': ""From the College of Medicine, King Saud Bin Abdulaziz University for Health Sciences (Y.M.A., S.J.A., S.A.I.A., A.A.-D.), the Departments of Intensive Care (Y.M.A., S.J.A., S.A.I.A., A.A.-D.) and Emergency Medicine, (S.J.A.), Ministry of National Guard Health Affairs, Military Medical Services, Ministry of Defense (Y. Mandourah), the Department of Intensive Care Services, Prince Sultan Military Medical City (G.A.A.), the Department of Pulmonary and Critical Care Medicine, King Fahad Medical City (M.A., H.L.), Critical Care Medicine Department, King Faisal Specialist Hospital and Research Center (H.H.), and the Department of Biostatistics and Bioinformatics (J.J.) and Research Office (L.Y.A.), King Abdullah International Medical Research Center (Y.M.A., S.J.A., S.A.I.A., A.A.-D.), Riyadh, College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, and the Intensive Care Department, Ministry of National Guard Health Affairs (F.A.-H.), and Critical Care Section, Department of Medicine, King Faisal Specialist Hospital and Research Center (I.K.), Jeddah, the Department of Emergency and Critical Care Medicine, College of Medicine, King Fahd Hospital of the University, Imam Abdulrahman Bin Faisal University (M.S.A.), Dammam, the Department of Critical Care Medicine, King Khalid University, Asir Central Hospital (A.A.B.), Abha, and King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, and the Intensive Care Division, Department of Medicine, King Abdulaziz Hospital (A.A.A.), Al Ahsa - all in Saudi Arabia; St. Michael's Hospital, Li Ka Shing Knowledge Institute (K.E.A.B.), the Department of Medicine, Sinai Health System (S.M.), and Interdepartmental Division of Critical Care Medicine, University of Toronto (K.E.A.B, S.M.) - all in Toronto; the George Institute for Global Health (S.F.), the Department of Intensive Care Medicine, Centre for Applied Medical Research, St. Vincent's Hospital (H.B.), and the University of New South Wales, Sydney (S.F., H.B.), and Intensive Care Department, Gosford Hospital, Gosford, NSW (A.G.) - all in Australia; and the Department of Anesthesiology and Critical Care, King George's Medical University, Lucknow (Z.A.), and Institute of Critical Care and Anesthesiology, Medanta-The Medicity, Gurgaon (Y. Mehta) - both in India.""}, {'ForeName': 'Atul', 'Initials': 'A', 'LastName': 'Gaur', 'Affiliation': ""From the College of Medicine, King Saud Bin Abdulaziz University for Health Sciences (Y.M.A., S.J.A., S.A.I.A., A.A.-D.), the Departments of Intensive Care (Y.M.A., S.J.A., S.A.I.A., A.A.-D.) and Emergency Medicine, (S.J.A.), Ministry of National Guard Health Affairs, Military Medical Services, Ministry of Defense (Y. Mandourah), the Department of Intensive Care Services, Prince Sultan Military Medical City (G.A.A.), the Department of Pulmonary and Critical Care Medicine, King Fahad Medical City (M.A., H.L.), Critical Care Medicine Department, King Faisal Specialist Hospital and Research Center (H.H.), and the Department of Biostatistics and Bioinformatics (J.J.) and Research Office (L.Y.A.), King Abdullah International Medical Research Center (Y.M.A., S.J.A., S.A.I.A., A.A.-D.), Riyadh, College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, and the Intensive Care Department, Ministry of National Guard Health Affairs (F.A.-H.), and Critical Care Section, Department of Medicine, King Faisal Specialist Hospital and Research Center (I.K.), Jeddah, the Department of Emergency and Critical Care Medicine, College of Medicine, King Fahd Hospital of the University, Imam Abdulrahman Bin Faisal University (M.S.A.), Dammam, the Department of Critical Care Medicine, King Khalid University, Asir Central Hospital (A.A.B.), Abha, and King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, and the Intensive Care Division, Department of Medicine, King Abdulaziz Hospital (A.A.A.), Al Ahsa - all in Saudi Arabia; St. Michael's Hospital, Li Ka Shing Knowledge Institute (K.E.A.B.), the Department of Medicine, Sinai Health System (S.M.), and Interdepartmental Division of Critical Care Medicine, University of Toronto (K.E.A.B, S.M.) - all in Toronto; the George Institute for Global Health (S.F.), the Department of Intensive Care Medicine, Centre for Applied Medical Research, St. Vincent's Hospital (H.B.), and the University of New South Wales, Sydney (S.F., H.B.), and Intensive Care Department, Gosford Hospital, Gosford, NSW (A.G.) - all in Australia; and the Department of Anesthesiology and Critical Care, King George's Medical University, Lucknow (Z.A.), and Institute of Critical Care and Anesthesiology, Medanta-The Medicity, Gurgaon (Y. Mehta) - both in India.""}, {'ForeName': 'Hassan', 'Initials': 'H', 'LastName': 'Hawa', 'Affiliation': ""From the College of Medicine, King Saud Bin Abdulaziz University for Health Sciences (Y.M.A., S.J.A., S.A.I.A., A.A.-D.), the Departments of Intensive Care (Y.M.A., S.J.A., S.A.I.A., A.A.-D.) and Emergency Medicine, (S.J.A.), Ministry of National Guard Health Affairs, Military Medical Services, Ministry of Defense (Y. Mandourah), the Department of Intensive Care Services, Prince Sultan Military Medical City (G.A.A.), the Department of Pulmonary and Critical Care Medicine, King Fahad Medical City (M.A., H.L.), Critical Care Medicine Department, King Faisal Specialist Hospital and Research Center (H.H.), and the Department of Biostatistics and Bioinformatics (J.J.) and Research Office (L.Y.A.), King Abdullah International Medical Research Center (Y.M.A., S.J.A., S.A.I.A., A.A.-D.), Riyadh, College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, and the Intensive Care Department, Ministry of National Guard Health Affairs (F.A.-H.), and Critical Care Section, Department of Medicine, King Faisal Specialist Hospital and Research Center (I.K.), Jeddah, the Department of Emergency and Critical Care Medicine, College of Medicine, King Fahd Hospital of the University, Imam Abdulrahman Bin Faisal University (M.S.A.), Dammam, the Department of Critical Care Medicine, King Khalid University, Asir Central Hospital (A.A.B.), Abha, and King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, and the Intensive Care Division, Department of Medicine, King Abdulaziz Hospital (A.A.A.), Al Ahsa - all in Saudi Arabia; St. Michael's Hospital, Li Ka Shing Knowledge Institute (K.E.A.B.), the Department of Medicine, Sinai Health System (S.M.), and Interdepartmental Division of Critical Care Medicine, University of Toronto (K.E.A.B, S.M.) - all in Toronto; the George Institute for Global Health (S.F.), the Department of Intensive Care Medicine, Centre for Applied Medical Research, St. Vincent's Hospital (H.B.), and the University of New South Wales, Sydney (S.F., H.B.), and Intensive Care Department, Gosford Hospital, Gosford, NSW (A.G.) - all in Australia; and the Department of Anesthesiology and Critical Care, King George's Medical University, Lucknow (Z.A.), and Institute of Critical Care and Anesthesiology, Medanta-The Medicity, Gurgaon (Y. Mehta) - both in India.""}, {'ForeName': 'Hergen', 'Initials': 'H', 'LastName': 'Buscher', 'Affiliation': ""From the College of Medicine, King Saud Bin Abdulaziz University for Health Sciences (Y.M.A., S.J.A., S.A.I.A., A.A.-D.), the Departments of Intensive Care (Y.M.A., S.J.A., S.A.I.A., A.A.-D.) and Emergency Medicine, (S.J.A.), Ministry of National Guard Health Affairs, Military Medical Services, Ministry of Defense (Y. Mandourah), the Department of Intensive Care Services, Prince Sultan Military Medical City (G.A.A.), the Department of Pulmonary and Critical Care Medicine, King Fahad Medical City (M.A., H.L.), Critical Care Medicine Department, King Faisal Specialist Hospital and Research Center (H.H.), and the Department of Biostatistics and Bioinformatics (J.J.) and Research Office (L.Y.A.), King Abdullah International Medical Research Center (Y.M.A., S.J.A., S.A.I.A., A.A.-D.), Riyadh, College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, and the Intensive Care Department, Ministry of National Guard Health Affairs (F.A.-H.), and Critical Care Section, Department of Medicine, King Faisal Specialist Hospital and Research Center (I.K.), Jeddah, the Department of Emergency and Critical Care Medicine, College of Medicine, King Fahd Hospital of the University, Imam Abdulrahman Bin Faisal University (M.S.A.), Dammam, the Department of Critical Care Medicine, King Khalid University, Asir Central Hospital (A.A.B.), Abha, and King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, and the Intensive Care Division, Department of Medicine, King Abdulaziz Hospital (A.A.A.), Al Ahsa - all in Saudi Arabia; St. Michael's Hospital, Li Ka Shing Knowledge Institute (K.E.A.B.), the Department of Medicine, Sinai Health System (S.M.), and Interdepartmental Division of Critical Care Medicine, University of Toronto (K.E.A.B, S.M.) - all in Toronto; the George Institute for Global Health (S.F.), the Department of Intensive Care Medicine, Centre for Applied Medical Research, St. Vincent's Hospital (H.B.), and the University of New South Wales, Sydney (S.F., H.B.), and Intensive Care Department, Gosford Hospital, Gosford, NSW (A.G.) - all in Australia; and the Department of Anesthesiology and Critical Care, King George's Medical University, Lucknow (Z.A.), and Institute of Critical Care and Anesthesiology, Medanta-The Medicity, Gurgaon (Y. Mehta) - both in India.""}, {'ForeName': 'Hani', 'Initials': 'H', 'LastName': 'Lababidi', 'Affiliation': ""From the College of Medicine, King Saud Bin Abdulaziz University for Health Sciences (Y.M.A., S.J.A., S.A.I.A., A.A.-D.), the Departments of Intensive Care (Y.M.A., S.J.A., S.A.I.A., A.A.-D.) and Emergency Medicine, (S.J.A.), Ministry of National Guard Health Affairs, Military Medical Services, Ministry of Defense (Y. Mandourah), the Department of Intensive Care Services, Prince Sultan Military Medical City (G.A.A.), the Department of Pulmonary and Critical Care Medicine, King Fahad Medical City (M.A., H.L.), Critical Care Medicine Department, King Faisal Specialist Hospital and Research Center (H.H.), and the Department of Biostatistics and Bioinformatics (J.J.) and Research Office (L.Y.A.), King Abdullah International Medical Research Center (Y.M.A., S.J.A., S.A.I.A., A.A.-D.), Riyadh, College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, and the Intensive Care Department, Ministry of National Guard Health Affairs (F.A.-H.), and Critical Care Section, Department of Medicine, King Faisal Specialist Hospital and Research Center (I.K.), Jeddah, the Department of Emergency and Critical Care Medicine, College of Medicine, King Fahd Hospital of the University, Imam Abdulrahman Bin Faisal University (M.S.A.), Dammam, the Department of Critical Care Medicine, King Khalid University, Asir Central Hospital (A.A.B.), Abha, and King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, and the Intensive Care Division, Department of Medicine, King Abdulaziz Hospital (A.A.A.), Al Ahsa - all in Saudi Arabia; St. Michael's Hospital, Li Ka Shing Knowledge Institute (K.E.A.B.), the Department of Medicine, Sinai Health System (S.M.), and Interdepartmental Division of Critical Care Medicine, University of Toronto (K.E.A.B, S.M.) - all in Toronto; the George Institute for Global Health (S.F.), the Department of Intensive Care Medicine, Centre for Applied Medical Research, St. Vincent's Hospital (H.B.), and the University of New South Wales, Sydney (S.F., H.B.), and Intensive Care Department, Gosford Hospital, Gosford, NSW (A.G.) - all in Australia; and the Department of Anesthesiology and Critical Care, King George's Medical University, Lucknow (Z.A.), and Institute of Critical Care and Anesthesiology, Medanta-The Medicity, Gurgaon (Y. Mehta) - both in India.""}, {'ForeName': 'Abdulsalam', 'Initials': 'A', 'LastName': 'Al Aithan', 'Affiliation': ""From the College of Medicine, King Saud Bin Abdulaziz University for Health Sciences (Y.M.A., S.J.A., S.A.I.A., A.A.-D.), the Departments of Intensive Care (Y.M.A., S.J.A., S.A.I.A., A.A.-D.) and Emergency Medicine, (S.J.A.), Ministry of National Guard Health Affairs, Military Medical Services, Ministry of Defense (Y. Mandourah), the Department of Intensive Care Services, Prince Sultan Military Medical City (G.A.A.), the Department of Pulmonary and Critical Care Medicine, King Fahad Medical City (M.A., H.L.), Critical Care Medicine Department, King Faisal Specialist Hospital and Research Center (H.H.), and the Department of Biostatistics and Bioinformatics (J.J.) and Research Office (L.Y.A.), King Abdullah International Medical Research Center (Y.M.A., S.J.A., S.A.I.A., A.A.-D.), Riyadh, College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, and the Intensive Care Department, Ministry of National Guard Health Affairs (F.A.-H.), and Critical Care Section, Department of Medicine, King Faisal Specialist Hospital and Research Center (I.K.), Jeddah, the Department of Emergency and Critical Care Medicine, College of Medicine, King Fahd Hospital of the University, Imam Abdulrahman Bin Faisal University (M.S.A.), Dammam, the Department of Critical Care Medicine, King Khalid University, Asir Central Hospital (A.A.B.), Abha, and King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, and the Intensive Care Division, Department of Medicine, King Abdulaziz Hospital (A.A.A.), Al Ahsa - all in Saudi Arabia; St. Michael's Hospital, Li Ka Shing Knowledge Institute (K.E.A.B.), the Department of Medicine, Sinai Health System (S.M.), and Interdepartmental Division of Critical Care Medicine, University of Toronto (K.E.A.B, S.M.) - all in Toronto; the George Institute for Global Health (S.F.), the Department of Intensive Care Medicine, Centre for Applied Medical Research, St. Vincent's Hospital (H.B.), and the University of New South Wales, Sydney (S.F., H.B.), and Intensive Care Department, Gosford Hospital, Gosford, NSW (A.G.) - all in Australia; and the Department of Anesthesiology and Critical Care, King George's Medical University, Lucknow (Z.A.), and Institute of Critical Care and Anesthesiology, Medanta-The Medicity, Gurgaon (Y. Mehta) - both in India.""}, {'ForeName': 'Sheryl A I', 'Initials': 'SAI', 'LastName': 'Abdukahil', 'Affiliation': ""From the College of Medicine, King Saud Bin Abdulaziz University for Health Sciences (Y.M.A., S.J.A., S.A.I.A., A.A.-D.), the Departments of Intensive Care (Y.M.A., S.J.A., S.A.I.A., A.A.-D.) and Emergency Medicine, (S.J.A.), Ministry of National Guard Health Affairs, Military Medical Services, Ministry of Defense (Y. Mandourah), the Department of Intensive Care Services, Prince Sultan Military Medical City (G.A.A.), the Department of Pulmonary and Critical Care Medicine, King Fahad Medical City (M.A., H.L.), Critical Care Medicine Department, King Faisal Specialist Hospital and Research Center (H.H.), and the Department of Biostatistics and Bioinformatics (J.J.) and Research Office (L.Y.A.), King Abdullah International Medical Research Center (Y.M.A., S.J.A., S.A.I.A., A.A.-D.), Riyadh, College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, and the Intensive Care Department, Ministry of National Guard Health Affairs (F.A.-H.), and Critical Care Section, Department of Medicine, King Faisal Specialist Hospital and Research Center (I.K.), Jeddah, the Department of Emergency and Critical Care Medicine, College of Medicine, King Fahd Hospital of the University, Imam Abdulrahman Bin Faisal University (M.S.A.), Dammam, the Department of Critical Care Medicine, King Khalid University, Asir Central Hospital (A.A.B.), Abha, and King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, and the Intensive Care Division, Department of Medicine, King Abdulaziz Hospital (A.A.A.), Al Ahsa - all in Saudi Arabia; St. Michael's Hospital, Li Ka Shing Knowledge Institute (K.E.A.B.), the Department of Medicine, Sinai Health System (S.M.), and Interdepartmental Division of Critical Care Medicine, University of Toronto (K.E.A.B, S.M.) - all in Toronto; the George Institute for Global Health (S.F.), the Department of Intensive Care Medicine, Centre for Applied Medical Research, St. Vincent's Hospital (H.B.), and the University of New South Wales, Sydney (S.F., H.B.), and Intensive Care Department, Gosford Hospital, Gosford, NSW (A.G.) - all in Australia; and the Department of Anesthesiology and Critical Care, King George's Medical University, Lucknow (Z.A.), and Institute of Critical Care and Anesthesiology, Medanta-The Medicity, Gurgaon (Y. Mehta) - both in India.""}, {'ForeName': 'Jesna', 'Initials': 'J', 'LastName': 'Jose', 'Affiliation': ""From the College of Medicine, King Saud Bin Abdulaziz University for Health Sciences (Y.M.A., S.J.A., S.A.I.A., A.A.-D.), the Departments of Intensive Care (Y.M.A., S.J.A., S.A.I.A., A.A.-D.) and Emergency Medicine, (S.J.A.), Ministry of National Guard Health Affairs, Military Medical Services, Ministry of Defense (Y. Mandourah), the Department of Intensive Care Services, Prince Sultan Military Medical City (G.A.A.), the Department of Pulmonary and Critical Care Medicine, King Fahad Medical City (M.A., H.L.), Critical Care Medicine Department, King Faisal Specialist Hospital and Research Center (H.H.), and the Department of Biostatistics and Bioinformatics (J.J.) and Research Office (L.Y.A.), King Abdullah International Medical Research Center (Y.M.A., S.J.A., S.A.I.A., A.A.-D.), Riyadh, College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, and the Intensive Care Department, Ministry of National Guard Health Affairs (F.A.-H.), and Critical Care Section, Department of Medicine, King Faisal Specialist Hospital and Research Center (I.K.), Jeddah, the Department of Emergency and Critical Care Medicine, College of Medicine, King Fahd Hospital of the University, Imam Abdulrahman Bin Faisal University (M.S.A.), Dammam, the Department of Critical Care Medicine, King Khalid University, Asir Central Hospital (A.A.B.), Abha, and King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, and the Intensive Care Division, Department of Medicine, King Abdulaziz Hospital (A.A.A.), Al Ahsa - all in Saudi Arabia; St. Michael's Hospital, Li Ka Shing Knowledge Institute (K.E.A.B.), the Department of Medicine, Sinai Health System (S.M.), and Interdepartmental Division of Critical Care Medicine, University of Toronto (K.E.A.B, S.M.) - all in Toronto; the George Institute for Global Health (S.F.), the Department of Intensive Care Medicine, Centre for Applied Medical Research, St. Vincent's Hospital (H.B.), and the University of New South Wales, Sydney (S.F., H.B.), and Intensive Care Department, Gosford Hospital, Gosford, NSW (A.G.) - all in Australia; and the Department of Anesthesiology and Critical Care, King George's Medical University, Lucknow (Z.A.), and Institute of Critical Care and Anesthesiology, Medanta-The Medicity, Gurgaon (Y. Mehta) - both in India.""}, {'ForeName': 'Lara Y', 'Initials': 'LY', 'LastName': 'Afesh', 'Affiliation': ""From the College of Medicine, King Saud Bin Abdulaziz University for Health Sciences (Y.M.A., S.J.A., S.A.I.A., A.A.-D.), the Departments of Intensive Care (Y.M.A., S.J.A., S.A.I.A., A.A.-D.) and Emergency Medicine, (S.J.A.), Ministry of National Guard Health Affairs, Military Medical Services, Ministry of Defense (Y. Mandourah), the Department of Intensive Care Services, Prince Sultan Military Medical City (G.A.A.), the Department of Pulmonary and Critical Care Medicine, King Fahad Medical City (M.A., H.L.), Critical Care Medicine Department, King Faisal Specialist Hospital and Research Center (H.H.), and the Department of Biostatistics and Bioinformatics (J.J.) and Research Office (L.Y.A.), King Abdullah International Medical Research Center (Y.M.A., S.J.A., S.A.I.A., A.A.-D.), Riyadh, College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, and the Intensive Care Department, Ministry of National Guard Health Affairs (F.A.-H.), and Critical Care Section, Department of Medicine, King Faisal Specialist Hospital and Research Center (I.K.), Jeddah, the Department of Emergency and Critical Care Medicine, College of Medicine, King Fahd Hospital of the University, Imam Abdulrahman Bin Faisal University (M.S.A.), Dammam, the Department of Critical Care Medicine, King Khalid University, Asir Central Hospital (A.A.B.), Abha, and King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, and the Intensive Care Division, Department of Medicine, King Abdulaziz Hospital (A.A.A.), Al Ahsa - all in Saudi Arabia; St. Michael's Hospital, Li Ka Shing Knowledge Institute (K.E.A.B.), the Department of Medicine, Sinai Health System (S.M.), and Interdepartmental Division of Critical Care Medicine, University of Toronto (K.E.A.B, S.M.) - all in Toronto; the George Institute for Global Health (S.F.), the Department of Intensive Care Medicine, Centre for Applied Medical Research, St. Vincent's Hospital (H.B.), and the University of New South Wales, Sydney (S.F., H.B.), and Intensive Care Department, Gosford Hospital, Gosford, NSW (A.G.) - all in Australia; and the Department of Anesthesiology and Critical Care, King George's Medical University, Lucknow (Z.A.), and Institute of Critical Care and Anesthesiology, Medanta-The Medicity, Gurgaon (Y. Mehta) - both in India.""}, {'ForeName': 'Abdulaziz', 'Initials': 'A', 'LastName': 'Al-Dawood', 'Affiliation': ""From the College of Medicine, King Saud Bin Abdulaziz University for Health Sciences (Y.M.A., S.J.A., S.A.I.A., A.A.-D.), the Departments of Intensive Care (Y.M.A., S.J.A., S.A.I.A., A.A.-D.) and Emergency Medicine, (S.J.A.), Ministry of National Guard Health Affairs, Military Medical Services, Ministry of Defense (Y. Mandourah), the Department of Intensive Care Services, Prince Sultan Military Medical City (G.A.A.), the Department of Pulmonary and Critical Care Medicine, King Fahad Medical City (M.A., H.L.), Critical Care Medicine Department, King Faisal Specialist Hospital and Research Center (H.H.), and the Department of Biostatistics and Bioinformatics (J.J.) and Research Office (L.Y.A.), King Abdullah International Medical Research Center (Y.M.A., S.J.A., S.A.I.A., A.A.-D.), Riyadh, College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, and the Intensive Care Department, Ministry of National Guard Health Affairs (F.A.-H.), and Critical Care Section, Department of Medicine, King Faisal Specialist Hospital and Research Center (I.K.), Jeddah, the Department of Emergency and Critical Care Medicine, College of Medicine, King Fahd Hospital of the University, Imam Abdulrahman Bin Faisal University (M.S.A.), Dammam, the Department of Critical Care Medicine, King Khalid University, Asir Central Hospital (A.A.B.), Abha, and King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, and the Intensive Care Division, Department of Medicine, King Abdulaziz Hospital (A.A.A.), Al Ahsa - all in Saudi Arabia; St. Michael's Hospital, Li Ka Shing Knowledge Institute (K.E.A.B.), the Department of Medicine, Sinai Health System (S.M.), and Interdepartmental Division of Critical Care Medicine, University of Toronto (K.E.A.B, S.M.) - all in Toronto; the George Institute for Global Health (S.F.), the Department of Intensive Care Medicine, Centre for Applied Medical Research, St. Vincent's Hospital (H.B.), and the University of New South Wales, Sydney (S.F., H.B.), and Intensive Care Department, Gosford Hospital, Gosford, NSW (A.G.) - all in Australia; and the Department of Anesthesiology and Critical Care, King George's Medical University, Lucknow (Z.A.), and Institute of Critical Care and Anesthesiology, Medanta-The Medicity, Gurgaon (Y. Mehta) - both in India.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa1816150'] 129,31537010,"The developing gut-lung axis: postnatal growth restriction, intestinal dysbiosis, and pulmonary hypertension in a rodent model.","BACKGROUND Postnatal growth restriction (PNGR) in premature infants increases risk of pulmonary hypertension (PH). In a rodent model, PNGR causes PH, while combining PNGR and hyperoxia increases PH severity. We hypothesized that PNGR causes intestinal dysbiosis and that treatment with a probiotic attenuates PNGR-associated PH. METHOD Pups were randomized at birth to room air or 75% oxygen (hyperoxia), to normal milk intake (10 pups/dam) or PNGR (17 pups/dam), and to probiotic Lactobacillus reuteri DSM 17938 or phosphate-buffered saline. After 14 days, PH was assessed by echocardiography and right ventricular hypertrophy (RVH) was assessed by Fulton's index (right ventricular weight/left ventricle + septal weight). The small bowel and cecum were analyzed by high-throughput 16S ribosomal RNA gene sequencing. RESULTS PNGR with or without hyperoxia (but not hyperoxia alone) altered the microbiota of the distal small bowel and cecum. Treatment with DSM 17938 attenuated PH and RVH in pups with PNGR, but not hyperoxia alone. DSM 17938 treatment decreased α-diversity. The intestinal microbiota differed based on oxygen exposure, litter size, and probiotic treatment. CONCLUSION PNGR causes intestinal dysbiosis and PH. Treatment with DSM 17938 prevents PNGR-associated RVH and PH. Changes in the developing intestine and intestinal microbiota impact the developing lung vasculature and RV.",2020,DSM 17938 treatment decreased α-diversity.,"['Pups were randomized at birth to', 'premature infants increases risk of pulmonary hypertension (PH']","['room air or 75% oxygen (hyperoxia), to normal milk intake (10 pups/dam) or PNGR', 'probiotic Lactobacillus reuteri DSM 17938 or phosphate-buffered saline', 'DSM', 'Postnatal growth restriction (PNGR']","['PNGR-associated RVH and PH', 'PH severity', 'echocardiography and right ventricular hypertrophy (RVH', 'small bowel and cecum', 'α-diversity', 'microbiota of the distal small bowel and cecum']","[{'cui': 'C1744681', 'cui_str': 'Congenital (qualifier value)'}, {'cui': 'C4048294', 'cui_str': 'Preterm Infant'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C1963999', 'cui_str': 'Pulmonary hypertension (SMQ)'}]","[{'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0556180', 'cui_str': 'Milk intake (observable entity)'}, {'cui': 'C0525033', 'cui_str': 'Probiotics'}, {'cui': 'C0317625', 'cui_str': 'Lactobacillus reuteri'}, {'cui': 'C1601799', 'cui_str': 'phosphate ion'}, {'cui': 'C0006353', 'cui_str': 'Buffers'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0243109', 'cui_str': 'postnatal growth'}]","[{'cui': 'C0162770', 'cui_str': 'Right Ventricular Hypertrophy'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0013516', 'cui_str': 'Transthoracic Echocardiography'}, {'cui': 'C0021852', 'cui_str': 'Intestines, Small'}, {'cui': 'C0007531', 'cui_str': 'Cecum'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C0205108', 'cui_str': 'Distal (qualifier value)'}]",,0.025137,DSM 17938 treatment decreased α-diversity.,"[{'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Wedgwood', 'Affiliation': 'Department of Pediatrics, UC Davis School of Medicine, Sacramento, CA, USA.'}, {'ForeName': 'Cris', 'Initials': 'C', 'LastName': 'Warford', 'Affiliation': 'Department of Pediatrics, UC Davis School of Medicine, Sacramento, CA, USA.'}, {'ForeName': 'Sharleen R', 'Initials': 'SR', 'LastName': 'Agvatisiri', 'Affiliation': 'Department of Pediatrics, UC Davis School of Medicine, Sacramento, CA, USA.'}, {'ForeName': 'Phung N', 'Initials': 'PN', 'LastName': 'Thai', 'Affiliation': 'Department of Internal Medicine, Division of Cardiovascular Medicine, UC Davis Health System, Sacramento, CA, USA.'}, {'ForeName': 'Nipavan', 'Initials': 'N', 'LastName': 'Chiamvimonvat', 'Affiliation': 'Department of Internal Medicine, Division of Cardiovascular Medicine, UC Davis Health System, Sacramento, CA, USA.'}, {'ForeName': 'Karen M', 'Initials': 'KM', 'LastName': 'Kalanetra', 'Affiliation': 'Department of Food Science and Technology, UC Davis, Davis, CA, USA.'}, {'ForeName': 'Satyan', 'Initials': 'S', 'LastName': 'Lakshminrusimha', 'Affiliation': 'Department of Pediatrics, UC Davis School of Medicine, Sacramento, CA, USA.'}, {'ForeName': 'Robin H', 'Initials': 'RH', 'LastName': 'Steinhorn', 'Affiliation': ""Department of Hospitalist Medicine, Children's National Health System, Washington, DC, USA.""}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Mills', 'Affiliation': 'Department of Food Science and Technology, UC Davis, Davis, CA, USA.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Underwood', 'Affiliation': 'Department of Pediatrics, UC Davis School of Medicine, Sacramento, CA, USA. munderwood@ucdavis.edu.'}]",Pediatric research,['10.1038/s41390-019-0578-2'] 130,32328782,Comparison of Lobectomy and Total Thyroidectomy in Unilateral Papillary Thyroid Microcarcinoma Patients with Ipsilateral Lateral Lymph Node Metastasis Without Gross Extrathyroidal Extension.,"BACKGROUND Lateral lymph node metastasis (LLNM) occurs in a few of papillary thyroid microcarcinoma (PTMC) cases by the time of diagnosis. Total thyroidectomy (TT) is recommended in the 2015 American Thyroid Association guidelines as the initial surgical procedure for thyroid carcinoma patients with clinically apparent cervical lymph node metastasis. However, none of the controlled studies have focused on the proper extent of surgery for patients who have PTMC with concomitant LLNM without gross extrathyroidal extension (ETE). METHODS A total of 2373 consecutive patients with PTMC were retrospectively reviewed. Finally, 129 unilateral PTMC patients with ipsilateral LLNM without gross ETE were enrolled in this study and classified into two groups: those who underwent unilateral lobectomy (LT) plus lymph node dissection (LND) (Group I) and those who underwent TT plus LND (Group II). Surgical outcomes and recurrence-free survival (RFS) during the follow-up period were compared between the two groups. RESULTS There were 62 patients in Group I and 67 patients in Group II. Cases in Group II had a longer median operation time (150 min vs. 120 min, p < 0.001) and a higher incidence of postoperative hypoparathyroidism (p < 0.001), especially permanent hypoparathyroidism, than cases in Group I. But the RFS showed no statistically significant difference (p = 0.6005) between the two groups during a median follow-up period of 60 months. CONCLUSION Thyroid LT alone plus ipsilateral LND may be an optimum initial procedure for unilateral PTMC patients with ipsilateral LLNM without gross ETE. A long-term follow-up, prospective, randomized controlled trial is warranted.",2020,"Cases in Group II had a longer median operation time (150 min vs. 120 min, p < 0.001) and a higher incidence of postoperative hypoparathyroidism (p < 0.001), especially permanent hypoparathyroidism, than cases in Group I.","['thyroid carcinoma patients with clinically apparent cervical lymph node metastasis', '2373 consecutive patients with PTMC', 'Unilateral Papillary Thyroid Microcarcinoma Patients with Ipsilateral Lateral Lymph Node Metastasis Without Gross Extrathyroidal Extension', 'unilateral PTMC patients with ipsilateral LLNM without gross ETE', 'patients who have PTMC with concomitant LLNM without gross extrathyroidal extension (ETE', '129 unilateral PTMC patients with ipsilateral LLNM without gross ETE']","['unilateral lobectomy (LT) plus lymph node dissection (LND', 'Lobectomy and Total Thyroidectomy', 'Total thyroidectomy (TT', 'TT plus LND', 'Thyroid LT alone plus ipsilateral LND']","['permanent hypoparathyroidism', 'postoperative hypoparathyroidism', 'longer median operation time', 'Surgical outcomes and recurrence-free survival (RFS']","[{'cui': 'C0549473', 'cui_str': 'Thyroid Cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0588054', 'cui_str': 'Cervical lymph node group'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1709457', 'cui_str': 'Papillary Thyroid Microcarcinoma'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0441989', 'cui_str': 'Ipsilateral'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0686619', 'cui_str': 'Secondary malignant neoplasm of lymph node'}, {'cui': 'C0439806', 'cui_str': 'Gross'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C1520439', 'cui_str': '129 Strain Mouse'}]","[{'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0023928', 'cui_str': 'Lobectomy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0024203', 'cui_str': 'Excision of lymph node'}, {'cui': 'C0193788', 'cui_str': 'Total thyroidectomy'}, {'cui': 'C0040145', 'cui_str': 'Thyroidectomy'}, {'cui': 'C0405532', 'cui_str': 'Lobectomy of thyroid gland'}, {'cui': 'C0441989', 'cui_str': 'Ipsilateral'}]","[{'cui': 'C0205355', 'cui_str': 'Permanent'}, {'cui': 'C0020626', 'cui_str': 'Hypoparathyroidism'}, {'cui': 'C0342341', 'cui_str': 'Post-surgical hypoparathyroidism'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C2919733', 'cui_str': 'Surviving free of recurrence of neoplastic disease'}]",2373.0,0.0291085,"Cases in Group II had a longer median operation time (150 min vs. 120 min, p < 0.001) and a higher incidence of postoperative hypoparathyroidism (p < 0.001), especially permanent hypoparathyroidism, than cases in Group I.","[{'ForeName': 'Jianlu', 'Initials': 'J', 'LastName': 'Song', 'Affiliation': ""Center of Thyroid and Parathyroid, Department of Thyroid, Parathyroid, Breast and Hernia Surgery, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, 600 Yi-Shan Road, Shanghai, 200233, People's Republic of China.""}, {'ForeName': 'Wangwang', 'Initials': 'W', 'LastName': 'Qiu', 'Affiliation': ""Center of Thyroid and Parathyroid, Department of Thyroid, Parathyroid, Breast and Hernia Surgery, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, 600 Yi-Shan Road, Shanghai, 200233, People's Republic of China.""}, {'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Yan', 'Affiliation': ""Center of Thyroid and Parathyroid, Department of Thyroid, Parathyroid, Breast and Hernia Surgery, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, 600 Yi-Shan Road, Shanghai, 200233, People's Republic of China.""}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Wu', 'Affiliation': ""Center of Thyroid and Parathyroid, Department of Thyroid, Parathyroid, Breast and Hernia Surgery, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, 600 Yi-Shan Road, Shanghai, 200233, People's Republic of China.""}, {'ForeName': 'Minggao', 'Initials': 'M', 'LastName': 'Guo', 'Affiliation': ""Center of Thyroid and Parathyroid, Department of Thyroid, Parathyroid, Breast and Hernia Surgery, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, 600 Yi-Shan Road, Shanghai, 200233, People's Republic of China.""}, {'ForeName': 'Youben', 'Initials': 'Y', 'LastName': 'Fan', 'Affiliation': ""Center of Thyroid and Parathyroid, Department of Thyroid, Parathyroid, Breast and Hernia Surgery, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, 600 Yi-Shan Road, Shanghai, 200233, People's Republic of China. fanyouben2006@163.com.""}, {'ForeName': 'Zhili', 'Initials': 'Z', 'LastName': 'Yang', 'Affiliation': ""Center of Thyroid and Parathyroid, Department of Thyroid, Parathyroid, Breast and Hernia Surgery, Shanghai Jiao Tong University Affiliated Sixth People's Hospital, 600 Yi-Shan Road, Shanghai, 200233, People's Republic of China. yangzhililaoshi@126.com.""}]",World journal of surgery,['10.1007/s00268-020-05514-1'] 131,32004693,One-month follow up of a randomized clinical trial-phase II study in 6 to <24 months old Indonesian subjects: Safety and immunogenicity of Vi-DT Typhoid Conjugate Vaccine.,"INTRODUCTION World Health Organization estimates the annual global incidence of typhoid fever at 11-21 million cases and approximately 128 000 to 161 000 deaths. The currently used Vi-polysaccharides (Vi-PS) vaccines have been proven to be safe and efficacious in children 2 years and above. However, poor immunogenicity of Vi-PS was observed in children below 2 years of age. This Phase II study is the continuation of the previously published Phase I study that aims to evaluate the safety and immunogenicity of a novel Vi-DT Typhoid Conjugate Vaccine (Bio Farma) in subjects 6 to <24 months. METHODS An interventional, blinded, comparative, randomized phase II study was conducted from July 2018 until January 2019. There were 200 healthy subjects divided into two groups: trial and control groups. Inactivated poliovirus vaccine was given to control group. Immediate and delayed local and systemic reactions up to 28 days post vaccination were recorded. Antibody titers were measured prior to vaccination (V1) and 28 days post vaccination (V2). RESULT The study showed that the seroconversion of Vi-DT vaccine 98.99%. One dose of Vi-DT vaccine induced higher geometric mean titers (GMT) in all subjects compared to that of baseline. Pain was the most common immediate and delayed local reaction. Immediate and delayed systemic reactions that mostly occurred was fever. There were no serious adverse events reported within 28 days post vaccination. CONCLUSION The novel typhoid Vi-DT conjugate vaccine is safe and immunogenic in children 6 to <24 months. TRIAL REGISTRATION NUMBER NCT03460405.",2020,One dose of Vi-DT vaccine induced higher geometric mean titers (GMT) in all subjects compared to that of baseline.,"['200 healthy subjects divided into two groups: trial and control groups', '6-<24 months old Indonesian subjects', 'July 2018 until January 2019', 'subjects 6-<24 months', 'typhoid fever at 11-21 million cases and approximately 128 000 to 161 000 deaths', 'children 6 to <24 months']","['Vi-polysaccharides (Vi-PS) vaccines', 'novel Vi-DT Typhoid Conjugate Vaccine (Bio Farma', 'Inactivated poliovirus vaccine', 'Vi-DT Typhoid Conjugate Vaccine', 'Vi-DT vaccine']","['immunogenicity of Vi-PS', 'Immediate and delayed local and systemic reactions', 'Pain', 'Antibody titers', 'Immediate and delayed systemic reactions', 'serious adverse events', 'geometric mean titers (GMT', 'safety and immunogenicity']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0337900', 'cui_str': 'Indonesians (ethnic group)'}, {'cui': 'C0041466', 'cui_str': 'Salmonella typhi Infection'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0332232', 'cui_str': 'Approximate (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0041466', 'cui_str': 'Salmonella typhi Infection'}, {'cui': 'C0206515', 'cui_str': 'Vaccines, Conjugate'}, {'cui': 'C0718003', 'cui_str': 'Poliovirus Vaccine, Inactivated'}, {'cui': 'C0058773', 'cui_str': 'DT Vaccine'}]","[{'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0443286', 'cui_str': 'Reaction (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1287242', 'cui_str': 'Finding of antibody titer (finding)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0475208', 'cui_str': 'TITR'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",200.0,0.147747,One dose of Vi-DT vaccine induced higher geometric mean titers (GMT) in all subjects compared to that of baseline.,"[{'ForeName': 'Bernie Endyarni', 'Initials': 'BE', 'LastName': 'Medise', 'Affiliation': 'Department of Child Health, Faculty of Medicine Universitas Indonesia, Dr. Cipto Mangunkusumo General National Hospital, Jakarta, Indonesia. Electronic address: bernie.medise@yahoo.com.'}, {'ForeName': 'Soedjatmiko', 'Initials': 'S', 'LastName': 'Soedjatmiko', 'Affiliation': 'Department of Child Health, Faculty of Medicine Universitas Indonesia, Dr. Cipto Mangunkusumo General National Hospital, Jakarta, Indonesia.'}, {'ForeName': 'Hartono', 'Initials': 'H', 'LastName': 'Gunardi', 'Affiliation': 'Department of Child Health, Faculty of Medicine Universitas Indonesia, Dr. Cipto Mangunkusumo General National Hospital, Jakarta, Indonesia.'}, {'ForeName': 'Rini', 'Initials': 'R', 'LastName': 'Sekartini', 'Affiliation': 'Department of Child Health, Faculty of Medicine Universitas Indonesia, Dr. Cipto Mangunkusumo General National Hospital, Jakarta, Indonesia.'}, {'ForeName': 'Hindra Irawan', 'Initials': 'HI', 'LastName': 'Satari', 'Affiliation': 'Department of Child Health, Faculty of Medicine Universitas Indonesia, Dr. Cipto Mangunkusumo General National Hospital, Jakarta, Indonesia.'}, {'ForeName': 'Sri Rezeki', 'Initials': 'SR', 'LastName': 'Hadinegoro', 'Affiliation': 'Department of Child Health, Faculty of Medicine Universitas Indonesia, Dr. Cipto Mangunkusumo General National Hospital, Jakarta, Indonesia.'}, {'ForeName': 'Angga', 'Initials': 'A', 'LastName': 'Wirahmadi', 'Affiliation': 'Department of Child Health, Faculty of Medicine Universitas Indonesia, Dr. Cipto Mangunkusumo General National Hospital, Jakarta, Indonesia.'}, {'ForeName': 'Mita', 'Initials': 'M', 'LastName': 'Puspita', 'Affiliation': 'PT. Bio Farma, Bandung, Indonesia.'}, {'ForeName': 'Rini Mulia', 'Initials': 'RM', 'LastName': 'Sari', 'Affiliation': 'PT. Bio Farma, Bandung, Indonesia.'}, {'ForeName': 'Jae Seung', 'Initials': 'JS', 'LastName': 'Yang', 'Affiliation': 'International Vaccine Institute, Seoul, Republic of Korea.'}, {'ForeName': 'Arijit', 'Initials': 'A', 'LastName': 'Sil', 'Affiliation': 'International Vaccine Institute, Seoul, Republic of Korea.'}, {'ForeName': 'Sushant', 'Initials': 'S', 'LastName': 'Sahastrabuddhe', 'Affiliation': 'International Vaccine Institute, Seoul, Republic of Korea.'}, {'ForeName': 'Novilia Sjafri', 'Initials': 'NS', 'LastName': 'Bachtiar', 'Affiliation': 'PT. Bio Farma, Bandung, Indonesia.'}]",International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases,['10.1016/j.ijid.2020.01.045'] 132,31641214,Preoperative liking and wanting for sweet beverages as predictors of body weight loss after Roux-en-Y gastric bypass and sleeve gastrectomy.,"BACKGROUND/OBJECTIVES Patients who receive Roux-en-Y gastric bypass (RYGB) lose more weight than those who receive vertical sleeve gastrectomy (VSG). RYGB and VSG alter hedonic responses to sweet flavor, but whether baseline differences in hedonic responses modulate weight loss after RYGB or VSG remains untested. PARTICIPANTS/METHODS Male and female candidates (n = 66) for RYGB or VSG were recruited and tested for their subjective liking and wanting ratings of sucrose solutions and flavored beverages sweetened with aspartame. Participants were classified by unsupervised hierarchical clustering for their liking and wanting ratings of sucrose and aspartame. Participant liking ratings were also used in a supervised classification using pre-established categories of liking ratings (liker, disliker, and inverted u-shape). Effects of categories obtained from unsupervised or supervised classification on body weight loss and their interaction with surgery type were analyzed separately at 3 and 12 months after surgery using linear models corrected for sex and age. RESULTS RYGB participants lost more body weight compared with VSG participants at 3 and 12 months after surgery (P < 0.001 for both time points). Unsupervised clustering analysis identified clusters corresponding to high and low wanting or liking ratings for sucrose or aspartame. RYGB participants in high-wanting clusters based on sucrose, but not aspartame, lost more weight than VSG at both 3 (P = 0.01) and 12 months (P = 0.03), yielding a significant cluster by surgery interaction. Categories based on supervised classification using liking ratings for sucrose or aspartame showed no significant effects on body weight loss between RYGB and VSG participants. CONCLUSIONS Classification of patients into high/low-wanting ratings for sucrose before surgery can predict differential body weight loss after RYGB or VSG in adults and could be used to advise on surgery type.",2020,"Categories based on supervised classification using liking ratings for sucrose or aspartame showed no significant effects on body weight loss between RYGB and VSG participants. ","['Patients who receive', 'Male and female candidates (n\u2009=\u200966) for RYGB or VSG']","['Roux-en-Y gastric bypass and sleeve gastrectomy', 'Preoperative liking and wanting for sweet beverages', 'RYGB and VSG', 'Roux-en-Y gastric bypass (RYGB', 'vertical sleeve gastrectomy (VSG', 'sucrose solutions and flavored beverages sweetened with aspartame', 'Unsupervised clustering analysis identified clusters corresponding to high and low wanting or liking ratings for sucrose or aspartame']","['Participant liking ratings', 'body weight', 'body weight loss']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}]","[{'cui': 'C0585179', 'cui_str': 'Roux-en-Y Gastric Bypass'}, {'cui': 'C3160799', 'cui_str': 'Sleeve gastrectomy'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C1444647', 'cui_str': 'Wanted'}, {'cui': 'C0453447', 'cui_str': 'Sugar candy'}, {'cui': 'C0005329', 'cui_str': 'Beverages'}, {'cui': 'C0205128', 'cui_str': 'Vertical (qualifier value)'}, {'cui': 'C0038636', 'cui_str': 'Sucrose'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}, {'cui': 'C0003999', 'cui_str': 'Aspartame'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}]","[{'cui': 'C0005910', 'cui_str': 'Body Weight'}]",,0.0158572,"Categories based on supervised classification using liking ratings for sucrose or aspartame showed no significant effects on body weight loss between RYGB and VSG participants. ","[{'ForeName': 'Claudio E', 'Initials': 'CE', 'LastName': 'Perez-Leighton', 'Affiliation': 'Department of Physiology, School of Biological Sciences, Pontificia Universidad Católica, Santiago, Chile.'}, {'ForeName': 'Jeon D', 'Initials': 'JD', 'LastName': 'Hamm', 'Affiliation': 'Department of Medicine, New York Nutrition Obesity Research Center and Division of Endocrinology, Vagelos College of Physicians and Surgeons, Columbia University Irving Medical Center, New York, NY, USA.'}, {'ForeName': 'Ari', 'Initials': 'A', 'LastName': 'Shechter', 'Affiliation': 'Department of Medicine, New York Nutrition Obesity Research Center and Division of Endocrinology, Vagelos College of Physicians and Surgeons, Columbia University Irving Medical Center, New York, NY, USA.'}, {'ForeName': 'Shoran', 'Initials': 'S', 'LastName': 'Tamura', 'Affiliation': 'Department of Medicine, New York Nutrition Obesity Research Center and Division of Endocrinology, Vagelos College of Physicians and Surgeons, Columbia University Irving Medical Center, New York, NY, USA.'}, {'ForeName': 'Blandine', 'Initials': 'B', 'LastName': 'Laferrère', 'Affiliation': 'Department of Medicine, New York Nutrition Obesity Research Center and Division of Endocrinology, Vagelos College of Physicians and Surgeons, Columbia University Irving Medical Center, New York, NY, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': 'Xavier Pi-Sunyer', 'Affiliation': 'Department of Medicine, New York Nutrition Obesity Research Center and Division of Endocrinology, Vagelos College of Physicians and Surgeons, Columbia University Irving Medical Center, New York, NY, USA.'}, {'ForeName': 'Jeanine', 'Initials': 'J', 'LastName': 'Albu', 'Affiliation': ""Mt. Sinai St. Luke's Hospital, New York, NY, USA.""}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Greenberg', 'Affiliation': 'NutriSci Incorporated, Mt. Kisco, NY, USA.'}, {'ForeName': 'Harry R', 'Initials': 'HR', 'LastName': 'Kissileff', 'Affiliation': 'Department of Medicine, New York Nutrition Obesity Research Center and Division of Endocrinology, Vagelos College of Physicians and Surgeons, Columbia University Irving Medical Center, New York, NY, USA. Harry.Kissileff2@mountsinai.org.'}]",International journal of obesity (2005),['10.1038/s41366-019-0474-1'] 133,31758523,"The effects of a comprehensive rehabilitation and intensive education program on anxiety, depression, quality of life, and major adverse cardiac and cerebrovascular events in unprotected left main coronary artery disease patients who underwent coronary artery bypass grafting.","OBJECTIVE This study aimed to explore the effect of a comprehensive rehabilitation and intensive education (CRIE) program on anxiety, depression, quality of life (QoL), and major adverse cardiac and cerebrovascular events (MACCE) risk in unprotected left main coronary artery disease (ULMCAD) patients who underwent coronary artery bypass grafting (CABG). METHODS In total, 300 ULMCAD patients who underwent CABG were randomly assigned to the CRIE group or usual care (UC) group in a 1:1 ratio. During a 12-month intervention, anxiety and depression were evaluated by Hospital Anxiety and Depression Scale (HADS), QoL was evaluated by 12-Item Short-Form Health Survey (SF-12), on discharge day from hospital (M0), and at 3 months after the discharge (M3), M6, and M12. All patients were further followed up until occurrence of MACCE or for an additional 24 months, and MACCE accumulating occurrence rate was calculated. RESULTS At M12, HADS-anxiety score and anxiety prevalence (17.3% vs. 29.3%) were decreased in the CRIE group than those in the UC group, meanwhile HADS-depression score and depression prevalence (15.3% vs. 24.7%) were also reduced in the CRIE group than those in the UC group. For QoL, SF-12 Physical Component Summary (PCS) score at M6/M12, and SF-12 PCS score change (M12 - M0) were increased in the CRIE group than those in the UC group; meanwhile, SF-12 Mental Component Summary (MCS) score at M12 and SF-12 PCS score change (M12 - M0) were increased in the CRIE group than those in the UC group as well. Besides, MACCE accumulating occurrence rate was numerically lower in the CRIE group compared with that in the UC group but without statistical significance. CONCLUSIONS CRIE is an effective approach in improving anxiety, depression, and QoL in ULMCAD patients who underwent CABG.",2020,"At M12, HADS-anxiety score and anxiety prevalence (17.3% vs. 29.3%) were decreased in the CRIE group than those in the UC group, meanwhile HADS-depression score and depression prevalence (15.3% vs. 24.7%) were also reduced in the CRIE group than those in the UC group.","['ULMCAD patients who underwent CABG', 'unprotected left main coronary artery disease patients who underwent coronary artery bypass grafting', '300 ULMCAD patients who underwent CABG']","['CRIE group or usual care (UC', 'comprehensive rehabilitation and intensive education (CRIE) program', 'CRIE', 'coronary artery bypass grafting (CABG', 'comprehensive rehabilitation and intensive education program']","['For QoL, SF-12 Physical Component Summary (PCS) score at M6/M12, and SF-12 PCS score change (M12 - M0', 'meanwhile HADS-depression score and depression prevalence', 'HADS-anxiety score and anxiety prevalence', 'anxiety, depression, and QoL', 'MACCE accumulating occurrence rate', 'SF-12 Mental Component Summary (MCS) score at M12 and SF-12 PCS score change (M12 - M0', 'Hospital Anxiety and Depression Scale (HADS), QoL was evaluated by 12-Item Short-Form Health Survey (SF-12), on discharge day from hospital (M0), and at 3 months after the discharge (M3), M6, and M12', 'anxiety, depression, quality of life (QoL), and major adverse cardiac and cerebrovascular events (MACCE) risk', 'anxiety, depression, quality of life, and major adverse cardiac and cerebrovascular events']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0010055', 'cui_str': 'Coronary Artery Bypass Grafting'}, {'cui': 'C1299433', 'cui_str': 'Left main coronary artery disease'}, {'cui': 'C4319604', 'cui_str': '300'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0729314', 'cui_str': 'Education provision (procedure)'}, {'cui': 'C0010055', 'cui_str': 'Coronary Artery Bypass Grafting'}]","[{'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0048008', 'cui_str': 'Benzenamine, 4-((4-aminophenyl)sulfonyl)-N-hydroxy-'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0451221', 'cui_str': 'Hospital anxiety and depression scale (assessment scale)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",,0.0241555,"At M12, HADS-anxiety score and anxiety prevalence (17.3% vs. 29.3%) were decreased in the CRIE group than those in the UC group, meanwhile HADS-depression score and depression prevalence (15.3% vs. 24.7%) were also reduced in the CRIE group than those in the UC group.","[{'ForeName': 'Liyuan', 'Initials': 'L', 'LastName': 'Ma', 'Affiliation': 'Department of Cardiovascular Surgery, The First Affiliated Hospital of Harbin Medical University, 23 Youzheng Street, Harbin, 150001, Heilongjiang, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Deng', 'Affiliation': 'Department of Cardiovascular Surgery, The First Affiliated Hospital of Harbin Medical University, 23 Youzheng Street, Harbin, 150001, Heilongjiang, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Yu', 'Affiliation': 'Department of Cardiovascular Surgery, The First Affiliated Hospital of Harbin Medical University, 23 Youzheng Street, Harbin, 150001, Heilongjiang, China. Yuhui6677@126.com.'}]",Irish journal of medical science,['10.1007/s11845-019-02129-x'] 134,31958404,"Effectiveness of post-partum family planning interventions on contraceptive use and method mix at 1 year after childbirth in Kinshasa, DR Congo (Yam Daabo): a single-blind, cluster-randomised controlled trial.","BACKGROUND In rural Burkina Faso, a package of six low-technology, post-partum contraceptive interventions (ie, refresher training for providers, a counselling tool, supportive supervision, daily availability of contraceptive services, client appointment cards, and invitation letters to attend appointments for partners), aimed at strengthening existing primary health-care services and enhancing demand for them, doubled the use of modern contraceptives at 12 months post partum (ie, 55% uptake in intervention recipients vs 29% in routine-care users). This study assessed the effect of a similar package but in urban settings of Kinshasa province, Democratic Republic of the Congo, in an effort to reduce the unmet need for post-partum family planning. METHODS Yam Daabo was a multi-intervention, single-blinded, cluster-randomised controlled trial done in six primary health-care centres (clusters) in Kinshasa. Centres were randomly allocated to receive the six-component intervention or standard antenatal and postnatal care in matched pairs (1:1) on the basis of number of monthly births, the ratio of health workers per population in the health zone, and the urban and suburban settings. Only data analysts could be masked to cluster allocation. Health-care facilities were eligible if they provided a continuum of antenatal, delivery, and postnatal care, were well stocked with contraceptives, and were situated close to the main study centre. All pregnant women presenting to the six centres were eligible if they were in their third pregnancy trimester and had no counterindications to deliver in the facility. The main outcome was prevalence of use of modern contraceptives at 12 months after delivery. Analysis was by modified intention-to-treat using generalised linear mixed models or Fisher's exact test for small groups. Prevalence ratios were adjusted for cluster effects and baseline characteristics. This study was registered with the Pan-African Clinical Trials Registry (PACTR201609001784334). FINDINGS From July 1, 2016, to Feb 2, 2017, eight of 52 clinics assessed for eligibility met the criteria and were randomised. Of 690 women approached, 576 (83%) women were enrolled: 286 in the four intervention clusters and 290 in the four control clusters. Of them, 519 (90%) completed the 12-month study exit interview (252 in the intervention group and 267 in the control group) and were included in the intention-to-treat analysis. At 12 months, 115 (46%) of 252 women in the intervention group and 94 (35%) of 267 in the control group were using modern contraceptives (adjusted prevalence ratio [PR] 1·58, 95% CI 0·74-3·38), with significant differences in the use of contraceptive implants (22% vs 6%; adjusted PR 4·36, 95% CI 1·96-9·70), but without difference in the use of short-acting contraceptives (23% vs 28%; 0·92, 0·29-2·98) and non-modern or inappropriate methods (7% vs 18%; 0·45, 0·13-1·54). There were no serious adverse events or maternal deaths related to the study. INTERPRETATION The Yam Daabo intervention package did not have a significant effect on the overall use of effective modern contraceptives but significantly increased implant use in women post partum who live in urban settings in Kinshasa up to a year after childbirth. However, interferences from external family planning initiatives in the control group might have diminished differences between the services received. Such an intervention could be potentially relevant in similar contexts in DR Congo and other countries. FUNDING Government of France; UNDP/UNFPA/UNICEF/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction.",2020,The Yam Daabo intervention package did not have a significant effect on the overall use of effective modern contraceptives but significantly increased implant use in women post partum who live in urban settings in Kinshasa up to a year after childbirth.,"['urban settings of Kinshasa province, Democratic Republic of the Congo', 'From July 1, 2016, to Feb 2, 2017, eight of 52 clinics assessed for eligibility met the criteria and were randomised', '690 women approached, 576 (83%) women were enrolled: 286 in the four intervention clusters and 290 in the four control clusters', 'Of them, 519 (90%) completed the 12-month study exit interview (252 in the intervention group and 267 in the control group) and were included in the intention-to-treat analysis', 'Government of France', 'six primary health-care centres (clusters) in Kinshasa', 'All pregnant women presenting to the six centres were eligible if they were in their third pregnancy trimester and had no counterindications to deliver in the facility']","['six-component intervention or standard antenatal and postnatal care in matched pairs (1:1) on the basis of number of monthly births, the ratio of health workers per population in the health zone, and the urban and suburban settings', 'post-partum family planning interventions']","['serious adverse events or maternal deaths', 'overall use of effective modern contraceptives', 'use of contraceptive implants', 'prevalence of use of modern contraceptives', 'Prevalence ratios']","[{'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0043444', 'cui_str': 'Belgian Congo'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0337094', 'cui_str': 'Exit (qualifier value)'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C0018104', 'cui_str': 'Government'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0032981', 'cui_str': 'Last Trimester'}]","[{'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C2828394', 'cui_str': 'Antenatal (qualifier value)'}, {'cui': 'C0032782', 'cui_str': 'Postpartum Care'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C1626935', 'cui_str': 'Base'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0009861', 'cui_str': 'Family Planning Services'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C3494405', 'cui_str': 'Maternal Death'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C0009871', 'cui_str': 'Contraceptives'}, {'cui': 'C1657106', 'cui_str': 'Contraceptive implant'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",690.0,0.242724,The Yam Daabo intervention package did not have a significant effect on the overall use of effective modern contraceptives but significantly increased implant use in women post partum who live in urban settings in Kinshasa up to a year after childbirth.,"[{'ForeName': 'Nguyen Toan', 'Initials': 'NT', 'LastName': 'Tran', 'Affiliation': 'Department of Reproductive Health and Research, World Health Organization, Geneva, Switzerland; Australian Centre for Public and Population Health Research, Faculty of Health, University of Technology, Sydney, NSW, Australia. Electronic address: nguyen-toan.tran@unige.ch.'}, {'ForeName': 'Armando', 'Initials': 'A', 'LastName': 'Seuc', 'Affiliation': 'Department of Reproductive Health and Research, World Health Organization, Geneva, Switzerland.'}, {'ForeName': 'Béatrice', 'Initials': 'B', 'LastName': 'Tshikaya', 'Affiliation': 'Programme National de Santé de la Reproduction, Kinshasa, Democratic Republic of the Congo.'}, {'ForeName': 'Maurice', 'Initials': 'M', 'LastName': 'Mutuale', 'Affiliation': 'School of Public Health, University of Kinshasa, Kinshasa, Democratic Republic of the Congo.'}, {'ForeName': 'Sihem', 'Initials': 'S', 'LastName': 'Landoulsi', 'Affiliation': 'Department of Reproductive Health and Research, World Health Organization, Geneva, Switzerland.'}, {'ForeName': 'Brigitte', 'Initials': 'B', 'LastName': 'Kini', 'Affiliation': 'World Health Organization Country Office in the Democratic Republic of the Congo, Kinshasa, Democratic Republic of the Congo.'}, {'ForeName': 'Bernadette', 'Initials': 'B', 'LastName': 'Mbu Nkolomonyi', 'Affiliation': 'World Health Organization Country Office in the Democratic Republic of the Congo, Kinshasa, Democratic Republic of the Congo.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Nyandwe Kyloka', 'Affiliation': 'School of Public Health, University of Kinshasa, Kinshasa, Democratic Republic of the Congo.'}, {'ForeName': 'Félicité', 'Initials': 'F', 'LastName': 'Langwana', 'Affiliation': 'School of Public Health, University of Kinshasa, Kinshasa, Democratic Republic of the Congo.'}, {'ForeName': 'Asa', 'Initials': 'A', 'LastName': 'Cuzin-Kihl', 'Affiliation': 'Department of Reproductive Health and Research, World Health Organization, Geneva, Switzerland.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Kiarie', 'Affiliation': 'Department of Reproductive Health and Research, World Health Organization, Geneva, Switzerland.'}, {'ForeName': 'Mary Eluned', 'Initials': 'ME', 'LastName': 'Gaffield', 'Affiliation': 'Department of Reproductive Health and Research, World Health Organization, Geneva, Switzerland.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Yodi', 'Affiliation': 'Programme National de Santé de la Reproduction, Kinshasa, Democratic Republic of the Congo.'}, {'ForeName': 'Désiré', 'Initials': 'D', 'LastName': 'Mashinda Kulimba', 'Affiliation': 'School of Public Health, University of Kinshasa, Kinshasa, Democratic Republic of the Congo.'}]",The Lancet. Global health,['10.1016/S2214-109X(19)30546-7'] 135,30652920,The impact of person-centred care on patients' care experiences in relation to educational level after acute coronary syndrome: secondary outcome analysis of a randomised controlled trial.,"BACKGROUND Research supporting the benefits of person-centred care is growing, still knowledge about patients' experiences of person-centred care is limited. AIM To evaluate the effects of person-centred care on patients' experiences of care, and also in relation to educational level, after an acute coronary syndrome. METHOD A total of 199 patients aged less than 75 years, hospitalised for acute coronary syndrome, were randomly assigned to either standard cardiac care ( n=105) or person-centred care plus standard cardiac care ( n=94). Experience of care was assessed at three healthcare settings (hospital, outpatient and primary care) using the 15-item Picker patient experience questionnaire plus two questions concerning information and documentation. RESULTS No significant difference was found at the three healthcare settings between the two study groups in the Picker patient experience questionnaire total score. Item level analysis showed that the person-centred care group significantly improved at all three healthcare settings on information received and in documentation of care compared with the standard cardiac care group ( P<0.05). In outpatient care, the person-centred care group reported significantly better family-physician communication ( P=0.004) and information for the family ( P=0.007) compared with the standard cardiac care group. In patients without postsecondary education, the corresponding figures were even more in favour of the person-centred care group ( P=0.0005 and P=0.0049, respectively), and they also reported higher involvement in care decisions ( P=0.023). CONCLUSION A person-centred care approach after an event of acute coronary syndrome improves patients' care experiences for information, shared documentation and involvement of family and friends. This effect was especially prominent in patients with a low educational level, who were also more involved in care decisions. TRIAL REGISTRATION Swedish registry, Researchweb.org , ID NR 65 791.",2019,No significant difference was found at the three healthcare settings between the two study groups in the Picker patient experience questionnaire total score.,"[""patients' care experiences in relation to educational level after acute coronary syndrome"", 'patients with a low educational level, who were also more involved in care decisions', '199 patients aged less than 75 years, hospitalised for acute coronary syndrome']","['person-centred care', 'standard cardiac care ( n=105) or person-centred care plus standard cardiac care']","['Picker patient experience questionnaire total score', 'care decisions', 'family-physician communication']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0948089', 'cui_str': 'Acute Coronary Syndrome'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0580931', 'cui_str': 'In care (finding)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0150158', 'cui_str': 'Cardiac care treatments and procedures'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1704221', 'cui_str': 'Physicians, Family'}, {'cui': 'C0009452', 'cui_str': 'Communication'}]",199.0,0.0784143,No significant difference was found at the three healthcare settings between the two study groups in the Picker patient experience questionnaire total score.,"[{'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Wolf', 'Affiliation': '1 Institute of Health and Care Sciences, University of Gothenburg, Sweden.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Vella', 'Affiliation': '2 Centre for Person-Centred Care (GPCC), University of Gothenburg, Sweden.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Fors', 'Affiliation': '1 Institute of Health and Care Sciences, University of Gothenburg, Sweden.'}]",European journal of cardiovascular nursing : journal of the Working Group on Cardiovascular Nursing of the European Society of Cardiology,['10.1177/1474515118821242'] 136,32053828,Global connectivity and local excitability changes underlie antidepressant effects of repetitive transcranial magnetic stimulation.,"Repetitive transcranial magnetic stimulation (rTMS) is a commonly- used treatment for major depressive disorder (MDD). However, our understanding of the mechanism by which TMS exerts its antidepressant effect is minimal. Furthermore, we lack brain signals that can be used to predict and track clinical outcome. Such signals would allow for treatment stratification and optimization. Here, we performed a randomized, sham-controlled clinical trial and measured electrophysiological, neuroimaging, and clinical changes before and after rTMS. Patients (N = 36) were randomized to receive either active or sham rTMS to the left dorsolateral prefrontal cortex (dlPFC) for 20 consecutive weekdays. To capture the rTMS-driven changes in connectivity and causal excitability, resting fMRI and TMS/EEG were performed before and after the treatment. Baseline causal connectivity differences between depressed patients and healthy controls were also evaluated with concurrent TMS/fMRI. We found that active, but not sham rTMS elicited (1) an increase in dlPFC global connectivity, (2) induction of negative dlPFC-amygdala connectivity, and (3) local and distributed changes in TMS/EEG potentials. Global connectivity changes predicted clinical outcome, while both global connectivity and TMS/EEG changes tracked clinical outcome. In patients but not healthy participants, we observed a perturbed inhibitory effect of the dlPFC on the amygdala. Taken together, rTMS induced lasting connectivity and excitability changes from the site of stimulation, such that after active treatment, the dlPFC appeared better able to engage in top-down control of the amygdala. These measures of network functioning both predicted and tracked clinical outcome, potentially opening the door to treatment optimization.",2020,Patients (N = 36) were randomized to receive either active or sham rTMS to the left dorsolateral prefrontal cortex (dlPFC) for 20 consecutive weekdays.,"['Patients (N\u2009=\u200936', 'depressed patients and healthy controls', 'major depressive disorder (MDD']","['Repetitive transcranial magnetic stimulation (rTMS', 'active or sham rTMS to the left dorsolateral prefrontal cortex (dlPFC', 'TMS', 'repetitive transcranial magnetic stimulation', 'rTMS']","['connectivity and causal excitability, resting fMRI and TMS/EEG', 'global connectivity and TMS/EEG changes tracked clinical outcome', 'dlPFC global connectivity, (2) induction of negative dlPFC-amygdala connectivity, and (3) local and distributed changes in TMS/EEG potentials']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}]","[{'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0450424', 'cui_str': 'To the left (qualifier value)'}, {'cui': 'C4019080', 'cui_str': 'Dorsolateral Prefrontal Cortex'}]","[{'cui': 'C0235169', 'cui_str': 'Excitability (finding)'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0376335', 'cui_str': 'fMRI'}, {'cui': 'C0013819', 'cui_str': 'EEG'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0040594', 'cui_str': 'Track'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0002708', 'cui_str': 'Amygdaloid Body'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}]",36.0,0.0327488,Patients (N = 36) were randomized to receive either active or sham rTMS to the left dorsolateral prefrontal cortex (dlPFC) for 20 consecutive weekdays.,"[{'ForeName': 'Neir', 'Initials': 'N', 'LastName': 'Eshel', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, 94305, USA.'}, {'ForeName': 'Corey J', 'Initials': 'CJ', 'LastName': 'Keller', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, 94305, USA.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Wu', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, 94305, USA.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Jiang', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, 94305, USA.'}, {'ForeName': 'Colleen', 'Initials': 'C', 'LastName': 'Mills-Finnerty', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, 94305, USA.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Huemer', 'Affiliation': 'Department of Child and Adolescent Psychiatry, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Rachael', 'Initials': 'R', 'LastName': 'Wright', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, 94305, USA.'}, {'ForeName': 'Gregory A', 'Initials': 'GA', 'LastName': 'Fonzo', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, 94305, USA.'}, {'ForeName': 'Naho', 'Initials': 'N', 'LastName': 'Ichikawa', 'Affiliation': 'Department of Psychiatry and Neurosciences, Hiroshima University, Hiroshima, Japan.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Carreon', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, 94305, USA.'}, {'ForeName': 'Melinda', 'Initials': 'M', 'LastName': 'Wong', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, 94305, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Yee', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, 94305, USA.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Shpigel', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, 94305, USA.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Guo', 'Affiliation': ""Department of Neurology, Shenzhen People's Hospital, Shenzhen, China.""}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'McTeague', 'Affiliation': 'Department of Psychiatry, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Adi', 'Initials': 'A', 'LastName': 'Maron-Katz', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, 94305, USA.'}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Etkin', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, 94305, USA. amitetkin@stanford.edu.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-020-0633-z'] 137,31086274,The effect of paired corticospinal-motoneuronal stimulation on maximal voluntary elbow flexion in cervical spinal cord injury: an experimental study.,"STUDY DESIGN Randomised, controlled, crossover study. OBJECTIVES Paired corticospinal-motoneuronal stimulation (PCMS) involves repeatedly pairing stimuli to corticospinal neurones and motoneurones to induce changes in corticospinal transmission. Here, we examined whether PCMS could enhance maximal voluntary elbow flexion in people with cervical spinal cord injury. SETTING Neuroscience Research Australia, Sydney, Australia. METHODS PCMS comprised 100 pairs of transcranial magnetic and electrical peripheral nerve stimulation (0.1 Hz), timed so corticospinal potentials arrived at corticospinal-motoneuronal synapses 1.5 ms before antidromic motoneuronal potentials. On two separate days, sets of five maximal elbow flexions were performed by 11 individuals with weak elbow flexors post C4 or C5 spinal cord injury before and after PCMS or control (100 peripheral nerve stimuli) conditioning. During contractions, supramaximal biceps brachii stimulation elicited superimposed twitches, which were expressed as a proportion of resting twitches to give maximal voluntary activation. Maximal torque and electromyographic activity were also assessed. RESULTS Baseline median (range) maximal torque was 11 Nm (6-41 Nm) and voluntary activation was 92% (62-99%). Linear mixed modelling revealed no significant differences between PCMS and control protocols after conditioning (maximal torque: p = 0.87, superimposed twitch: p = 0.87, resting twitch: p = 0.44, voluntary activation: p = 0.36, biceps EMG: p = 0.25, brachioradialis EMG: 0.67). CONCLUSIONS Possible explanations for the lack of effect include a potential ceiling effect for voluntary activation, or that PCMS may be less effective for elbow flexors than distal muscles. Despite results, previous studies suggest that PCMS is worthy of further investigation.",2019,"Linear mixed modelling revealed no significant differences between PCMS and control protocols after conditioning (maximal torque: p = 0.87, superimposed twitch: p = 0.87, resting twitch: p = 0.44, voluntary activation: p = 0.36, biceps EMG: p = 0.25, brachioradialis EMG: 0.67). ","['cervical spinal cord injury', 'Neuroscience Research Australia, Sydney, Australia', '11 individuals with weak elbow flexors post C4 or C5 spinal cord injury before and after', 'people with cervical spinal cord injury', 'PCMS comprised 100 pairs of']","['PCMS or control (100 peripheral nerve stimuli) conditioning', 'Paired corticospinal-motoneuronal stimulation (PCMS', 'PCMS', 'transcranial magnetic and electrical peripheral nerve stimulation (0.1\u2009Hz), timed so corticospinal potentials arrived at corticospinal-motoneuronal synapses 1.5\u2009ms before antidromic motoneuronal potentials', 'paired corticospinal-motoneuronal stimulation']","['maximal voluntary elbow flexion', 'voluntary activation', 'Maximal torque and electromyographic activity', 'Baseline median (range) maximal torque']","[{'cui': 'C0840414', 'cui_str': 'Cervical spinal cord injury'}, {'cui': 'C0027910', 'cui_str': 'Neurosciences'}, {'cui': 'C0035168'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C1762617', 'cui_str': 'Weak (qualifier value)'}, {'cui': 'C0013769', 'cui_str': 'Elbow'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0037929', 'cui_str': 'Spinal Cord Trauma'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0031119', 'cui_str': 'Peripheral Nerves'}, {'cui': 'C0234402', 'cui_str': 'Stimulus, function (observable entity)'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0442348', 'cui_str': 'Transcranial approach (qualifier value)'}, {'cui': 'C0024488', 'cui_str': 'Magnetics'}, {'cui': 'C0436544', 'cui_str': 'Electrical peripheral nerve stimulation (procedure)'}, {'cui': 'C4517420', 'cui_str': 'Zero point one'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0039062', 'cui_str': 'Synapses'}, {'cui': 'C3844012', 'cui_str': '1.5'}]","[{'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0439656', 'cui_str': 'Voluntary (qualifier value)'}, {'cui': 'C0013769', 'cui_str': 'Elbow'}, {'cui': 'C0231452', 'cui_str': 'Flexion, function (observable entity)'}, {'cui': 'C0376590', 'cui_str': 'Torque'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]",,0.0859074,"Linear mixed modelling revealed no significant differences between PCMS and control protocols after conditioning (maximal torque: p = 0.87, superimposed twitch: p = 0.87, resting twitch: p = 0.44, voluntary activation: p = 0.36, biceps EMG: p = 0.25, brachioradialis EMG: 0.67). ","[{'ForeName': 'Siobhan C', 'Initials': 'SC', 'LastName': 'Dongés', 'Affiliation': 'Neuroscience Research Australia, Sydney, Australia.'}, {'ForeName': 'Claire L', 'Initials': 'CL', 'LastName': 'Boswell-Ruys', 'Affiliation': 'Neuroscience Research Australia, Sydney, Australia.'}, {'ForeName': 'Jane E', 'Initials': 'JE', 'LastName': 'Butler', 'Affiliation': 'Neuroscience Research Australia, Sydney, Australia.'}, {'ForeName': 'Janet L', 'Initials': 'JL', 'LastName': 'Taylor', 'Affiliation': 'Neuroscience Research Australia, Sydney, Australia. janet.taylor@ecu.edu.au.'}]",Spinal cord,['10.1038/s41393-019-0291-3'] 138,32320139,The Effect of Acupressure on Acute Pain During Venipuncture in Children: Implications for Evidence-Based Practice.,"AIMS The study was conducted as a randomized controlled trial in order to determine the effects of acupressure on acute pain during venipuncture in children. METHODS The population of the study consisted of children, aged between 9 and 12 years, who received venipuncture between September 2015 and June 2016 at a university hospital in Istanbul. The sample consisted of a total of 90 children, including 45 children in the acupressure group and 45 children in the control group, who met the sample inclusion criteria. The results of the study were obtained by using an information form, the State Anxiety Inventory for Children (STAIC), the visual analog scale (VAS), and the Faces Pain Scale-Revised (FPS-R). Acupressure was applied to the children in the acupressure group for 10 min before the venipuncture procedure. Pain, heart rate, and oxygen saturation levels of the children in the acupressure and control groups were evaluated both before and after the venipuncture procedure. RESULTS The children in the acupressure and control groups were found to be similar in terms of age, gender, parents' educational levels and working status, number of venipuncture procedures, and mean anxiety scores. In the evaluation that was conducted before the venipuncture procedure, no statistically significant differences were observed between the heat rates, oxygen saturation levels, and expected pain scores from the venipuncture procedure in the children in the acupressure and control groups. On the other hand, it was observed that the children in the acupressure group (VAS: 19.51 ± 4.98; FPS-R: 2.08 ± 0.41) experienced less pain than the children in the control group (VAS: 47.37 ± 9.89; FPS-R: 4.84 ± 1.08), and there was a significant difference between the two groups (p< .000). LINKING EVIDENCE TO ACTION Acupressure administration is effective in reducing the pain that is experienced by children during a venipuncture procedure.",2020,"The children in the acupressure and control groups were found to be similar in terms of age, gender, parents' educational levels and working status, number of venipuncture procedures, and mean anxiety scores.","['90 children, including 45 children in the acupressure group and 45 children in the control group, who met the sample inclusion criteria', 'children', 'children, aged between 9 and 12\xa0years, who received venipuncture between September 2015 and June 2016 at a university hospital in Istanbul', 'Children']","['acupressure', 'Acupressure']","['Pain, heart rate, and oxygen saturation levels', 'Acute Pain', 'State Anxiety Inventory for Children (STAIC), the visual analog scale (VAS), and the Faces Pain Scale-Revised (FPS-R', 'acute pain', 'heat rates, oxygen saturation levels, and expected pain scores', 'pain', 'educational levels and working status, number of venipuncture procedures, and mean anxiety scores']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0282614', 'cui_str': 'Acupressure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0190979', 'cui_str': 'Phlebotomy'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}]","[{'cui': 'C0282614', 'cui_str': 'Acupressure'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0184567', 'cui_str': 'Acute pain'}, {'cui': 'C0700613', 'cui_str': 'Anxiety state'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0015468', 'cui_str': 'Pain in face'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0013658', 'cui_str': 'Educational achievement'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0600406', 'cui_str': 'Venipuncture'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",90.0,0.0468035,"The children in the acupressure and control groups were found to be similar in terms of age, gender, parents' educational levels and working status, number of venipuncture procedures, and mean anxiety scores.","[{'ForeName': 'Tuba', 'Initials': 'T', 'LastName': 'Koç Özkan', 'Affiliation': 'Midwifery Department, Adiyaman University Faculty of Health Sciences, Adiyaman, Turkey.'}, {'ForeName': 'Serap', 'Initials': 'S', 'LastName': 'Balcı', 'Affiliation': 'Department of Child Health and Diseases Nursing, Florence Nightingale Faculty of Nursing, Istanbul University, Istanbul, Turkey.'}]",Worldviews on evidence-based nursing,['10.1111/wvn.12437'] 139,31626568,"Effects of Motor Imagery and Action Observation on Lumbo-pelvic Motor Control, Trunk Muscles Strength and Level of Perceived Fatigue: A Randomized Controlled Trial.","Purpose : The aim of the study was to evaluate the effects of motor imagery (MI) and action observation (AO) combined with a motor control exercises program for the lumbopelvic region. Method : Forty-five asymptomatic individuals were randomized into three groups: MI (n = 15), AO (n = 15) or control group (CG) (n = 15). The outcome measures included lumbopelvic motor control measured with a stabilizer pressure biofeedback, trunk muscle strength using a dynamometer and the perceived fatigue using a visual analogue scale. Participants were assessed at pre-intervention, at first week of intervention (mid) and post-intervention. Results : Regarding lumbopelvic motor control, we observed significant within-group differences between pre- and the mid and post-intervention assessment in AO group ( p < .001, d > 0.80). MI and CG groups showed significant differences between pre- and post-intervention assessment (p < .05, d > 0.80). Regarding the direct comparison in the ΔMid-Pre differences between groups, only the AO group was superior to the CG with a large effect size (d > 0.80). Regarding trunk muscle strength, significant within-group differences between pre- and post-intervention assessments were observed in AO (p < .001, d = -1.25) and MI (p < .05, d = -1.00) groups. In relation to the perceived fatigue, statistically significant within-group differences were found in all groups (p < .05, d > 0.60). Conclusion : AO training caused faster changes in lumbopelvic motor control compared with the CG group. The AO strategy could be used as a guideline for teaching lumbopelvic motor control exercises.",2020,"In relation to the perceived fatigue, statistically significant within-group differences were found in all groups (p < .05, d > 0.60). ",['Method : Forty-five asymptomatic individuals'],"['Motor Imagery and Action Observation', 'motor imagery (MI) and action observation (AO) combined with a motor control exercises program', 'control group (CG']","['lumbopelvic motor control measured with a stabilizer pressure biofeedback, trunk muscle strength using a dynamometer and the perceived fatigue using a visual analogue scale', 'lumbopelvic motor control', 'Lumbo-pelvic Motor Control, Trunk Muscles Strength and Level of Perceived Fatigue']","[{'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic (finding)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C0150627', 'cui_str': 'Imagery'}, {'cui': 'C0441472', 'cui_str': 'Action (qualifier value)'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0678663', 'cui_str': 'Biofeedback, function (observable entity)'}, {'cui': 'C0460005', 'cui_str': 'Torso'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0180572', 'cui_str': 'Dynamometer (physical object)'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0030797', 'cui_str': 'Pelvic Region'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",,0.0224723,"In relation to the perceived fatigue, statistically significant within-group differences were found in all groups (p < .05, d > 0.60). ","[{'ForeName': 'Ferran', 'Initials': 'F', 'LastName': 'Cuenca-Martínez', 'Affiliation': 'Universidad Autónoma de Madrid.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Suso-Martí', 'Affiliation': 'Universidad Autónoma de Madrid.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Sánchez-Martín', 'Affiliation': 'Universidad Autónoma de Madrid.'}, {'ForeName': 'Clara', 'Initials': 'C', 'LastName': 'Soria-Soria', 'Affiliation': 'Universidad Autónoma de Madrid.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Serrano-Santos', 'Affiliation': 'Universidad Autónoma de Madrid.'}, {'ForeName': 'Alba', 'Initials': 'A', 'LastName': 'Paris-Alemany', 'Affiliation': 'Universidad Autónoma de Madrid.'}, {'ForeName': 'Roy', 'Initials': 'R', 'LastName': 'La Touche', 'Affiliation': 'Universidad Autónoma de Madrid.'}, {'ForeName': 'Jose Vicente', 'Initials': 'JV', 'LastName': 'León-Hernández', 'Affiliation': 'Universidad Autónoma de Madrid.'}]",Research quarterly for exercise and sport,['10.1080/02701367.2019.1645941'] 140,32311700,Effects of vitamin D supplementation on circulating concentrations of growth factors and immune-mediators in healthy women during pregnancy.,"BACKGROUND For the second aim of the Kellogg Foundation grant, this double-blind RCT investigated the impact of plasma vitamin D metabolite 25-hydroxyvitamin D (25(OH)D) on plasma immune-mediators during pregnancy. We hypothesized that higher 25(OH)D concentrations would associate with reduced pro-inflammatory and increased tolerogenic immune-mediator concentrations. METHODS Pregnant women enrolled at 10-14 weeks gestation were randomized to 400 or 4400 IU vitamin D 3 /day. Data on health, safety, circulating 25(OH)D, and 9 immune-mediators were collected at each trimester. Associations between immune-mediators and 25(OH)D at baseline and at second and third trimesters were examined. RESULTS Baseline TGF-β and second and third trimesters IFN-γ and IL-2 were associated with baseline 25(OH)D. Baseline immune-mediators were associated with immune-mediators at second and third trimesters for all immune-mediators except IL-5 and IL-10. Race was associated with baseline TGF-β, VEGF and IL-10 and with IL-10 at second and third trimesters. CONCLUSIONS Both treatment groups had increased 25(OH)D at second and third trimesters, greatest in the 4400 IU group. Though associations between baseline 25(OH)D and baseline TGF-β and second and third trimester IFN-γ and IL-2 were noted, vitamin D supplementation throughout pregnancy did not impact immune-mediators at later trimesters. Supplementing with vitamin D before conception conceivably influences immune-mediator responses during pregnancy. IMPACT In this vitamin D supplementation clinical trial, baseline (first trimester) but not increasing plasma 25(OH)D concentration impacted select plasma immune-mediator profiles in pregnant women. Baseline 25(OH)D was associated with baseline TGF-β and with IFN-γ and IL-2 at second and third trimesters. Baseline IFN-γ, CRP, TGF-β, TNF-α, VEGF, IL-2, and IL-4 were associated with concentrations at second and third trimesters for respective immune-mediators; however, 25(OH)D concentration at second and third trimesters were not. Some racial differences existed in immune-mediator concentrations at baseline and at second and third trimesters. This study assesses the impact of vitamin D supplementation on multiple immune-mediators in pregnant women of different racial/ethnic groups using longitudinal data from a relatively large randomized controlled trial. This study found that race was associated with baseline TGF-β, VEGF, and IL-10 and with IL-10 at second and third trimesters, a novel finding that sheds light where relationships were less well defined. The results of this study suggest that vitamin D supplementation before conception or early in pregnancy, rather than during pregnancy, may be necessary to significantly impact immune-mediator response. This study sets premise for future clinical trials to evaluate the effect of vitamin D supplementation before conception or prior to pregnancy.",2020,"IL-10. Race was associated with baseline TGF-β, VEGF and IL-10 and with IL-10 at second and third trimesters. ","['pregnant women', 'Pregnant women enrolled at 10-14 weeks gestation', 'pregnant women of different racial/ethnic groups', 'healthy women during pregnancy']","['vitamin D 3 /day', 'vitamin D supplementation', 'plasma vitamin D metabolite 25-hydroxyvitamin D (25(OH)D', 'vitamin D']","['Baseline IFN-γ, CRP, TGF-β, TNF-α, VEGF, IL-2, and IL-4', 'baseline TGF-β, VEGF and IL-10 and with IL-10 at second and third trimesters', 'immune-mediator concentrations', 'health, safety, circulating 25(OH)D, and 9 immune-mediators', 'multiple immune-mediators', '25(OH)D concentration', 'immune-mediator responses', 'baseline TGF-β, VEGF, and IL-10 and with IL-10', 'circulating concentrations of growth factors and immune-mediators']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0591126', 'cui_str': 'AT-10'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0015031', 'cui_str': 'Ethnic group'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0006657', 'cui_str': 'Calcifediol'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0040691', 'cui_str': 'Transforming Growth Factor'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0078058', 'cui_str': 'Vascular endothelial growth factor'}, {'cui': 'C0021756', 'cui_str': 'Interleukin-2'}, {'cui': 'C0021758', 'cui_str': 'Interleukin-4'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0032981', 'cui_str': 'Third trimester pregnancy'}, {'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0018284', 'cui_str': 'Growth factor'}]",,0.420897,"IL-10. Race was associated with baseline TGF-β, VEGF and IL-10 and with IL-10 at second and third trimesters. ","[{'ForeName': 'Aastha', 'Initials': 'A', 'LastName': 'Khatiwada', 'Affiliation': 'Department of Public Health Sciences, Medical University of South Carolina, Charleston, SC, 29425, USA.'}, {'ForeName': 'Bethany J', 'Initials': 'BJ', 'LastName': 'Wolf', 'Affiliation': 'Department of Public Health Sciences, Medical University of South Carolina, Charleston, SC, 29425, USA.'}, {'ForeName': 'Jennifer K', 'Initials': 'JK', 'LastName': 'Mulligan', 'Affiliation': 'Department of Otolaryngology - Head & Neck Surgery, Medical University of South Carolina, Charleston, SC, 29425, USA.'}, {'ForeName': 'Judy R', 'Initials': 'JR', 'LastName': 'Shary', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, Medical University of South Carolina, Charleston, SC, 29425, USA.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Hewison', 'Affiliation': 'Institute of Metabolism and Systems Research, University of Birmingham, Medical School, IBR Tower, Level 2, Birmingham, B15 2TT, UK.'}, {'ForeName': 'John E', 'Initials': 'JE', 'LastName': 'Baatz', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, Medical University of South Carolina, Charleston, SC, 29425, USA.'}, {'ForeName': 'Danforth A', 'Initials': 'DA', 'LastName': 'Newton', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, Medical University of South Carolina, Charleston, SC, 29425, USA.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Hawrylowicz', 'Affiliation': ""Division of Asthma, Allergy and Lung Biology, King's College London, Guy's Hospital, London, UK.""}, {'ForeName': 'Bruce W', 'Initials': 'BW', 'LastName': 'Hollis', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, Medical University of South Carolina, Charleston, SC, 29425, USA.'}, {'ForeName': 'Carol L', 'Initials': 'CL', 'LastName': 'Wagner', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, Medical University of South Carolina, Charleston, SC, 29425, USA. wagnercl@musc.edu.'}]",Pediatric research,['10.1038/s41390-020-0885-7'] 141,32331270,Change in the Mindset of a Paediatric Exercise Physiologist: A Review of Fifty Years Research.,"In this review, the career of a pediatric exercise physiologist (HCGK) is given over a period of almost 50 years. His research was concentrated on the relationship of physical activity (physical education, sport, and daily physical activity) with health and fitness in teenagers in secondary schools. (1) His first experiment was an exercise test on a bicycle ergometer to measure aerobic fitness by estimating physical work capacity at a heart rate of 170 beats/minute (PWC 170 ). (2) Secondly, a randomized control trial (RCT) was performed with an intervention of more intensive physical education (PE) with circuit interval training during three lessons per week over a period of six weeks. (3) Thereafter, a second RCT was performed with an intervention of two extra PE lessons per week over a whole school year. The results of these two RCTs appeared to be small or nonsignificant, probably because the effects were confounded by differences in maturation and the habitual physical activity of these teenagers. (4) Therefore, the scope of the research was changed into the direction of a long-term longitudinal study (the Amsterdam Growth And Health Longitudinal Study). This study included male and female teenagers that were followed over many years to get insight into the individual changes in biological factors (growth, fitness, obesity, hypercholesterolemia, and hypertension) and lifestyle parameters such as nutrition, smoking, alcohol usage, and daily physical activity. With the help of new advanced statistical methods (generalized estimating equations, random coefficient analysis, and autoregression analysis) suitable for longitudinal data, research questions regarding repeated measurements, tracking, or stability were answered. New measurement techniques such as mineral bone density by means of dual-energy X-ray absorptiometry (DEXA) showed that bone can also be influenced by short bursts of mechanical load. This changed his mind: In children and adolescents, not only can daily aerobic exercise of at least 30 to 60 minutes duration increase the aerobic power of muscles, but very short highly intensive bursts of less than one minute per day can also increase the strength of their bones.",2020,"His research was concentrated on the relationship of physical activity (physical education, sport, and daily physical activity) with health and fitness in teenagers in secondary schools.","['male and female teenagers', 'teenagers in secondary schools']","['intensive physical education (PE) with circuit interval training', 'pediatric exercise physiologist (HCGK']","['habitual physical activity', 'strength of their bones', 'biological factors (growth, fitness, obesity, hypercholesterolemia, and hypertension) and lifestyle parameters such as nutrition, smoking, alcohol usage, and daily physical activity']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0036530', 'cui_str': 'Secondary school'}]","[{'cui': 'C0031805', 'cui_str': 'Education, Physical'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0260141', 'cui_str': 'Physiologist'}]","[{'cui': 'C0205353', 'cui_str': 'Habitual'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0005515', 'cui_str': 'Biological agent'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0020443', 'cui_str': 'Hypercholesterolemia'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0457083', 'cui_str': 'Usage'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",,0.0270298,"His research was concentrated on the relationship of physical activity (physical education, sport, and daily physical activity) with health and fitness in teenagers in secondary schools.","[{'ForeName': 'Han C G', 'Initials': 'HCG', 'LastName': 'Kemper', 'Affiliation': 'Emeritus Professor in Health and Physical Activity, Amsterdam UMC, Amsterdam Public Health Research Institute, 1081 BT Amsterdam, The Netherlands.'}]",International journal of environmental research and public health,['10.3390/ijerph17082888'] 142,32139250,Letter to the Editor: Effect of fatty fish or nut consumption on concentrations of persistent organic pollutants in overweight or obese men and women: A randomized controlled clinical trial.,,2020,,['overweight or obese men and women'],['fatty fish or nut consumption'],[],"[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C0453017', 'cui_str': 'Fatty fish (substance)'}, {'cui': 'C0028723', 'cui_str': 'Nuts'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]",[],,0.124,,"[{'ForeName': 'Yu-Mi', 'Initials': 'YM', 'LastName': 'Lee', 'Affiliation': 'Department of Preventive Medicine, School of Medicine, Kyungpook National University, Daegu, Republic of Korea.'}, {'ForeName': 'Duk-Hee', 'Initials': 'DH', 'LastName': 'Lee', 'Affiliation': 'Department of Preventive Medicine, School of Medicine, Kyungpook National University, Daegu, Republic of Korea; BK21 Plus KNU Biomedical Convergence Program, Department of Biomedical Science, Kyungpook National University, Republic of Korea. Electronic address: lee_dh@knu.ac.kr.'}]","Nutrition, metabolism, and cardiovascular diseases : NMCD",['10.1016/j.numecd.2020.01.015'] 143,32297396,Effects of an intervention combining self-care and self-hypnosis on fatigue and associated symptoms in post-treatment cancer patients: A randomized-controlled trial.,"OBJECTIVE Cancer has a lot of consequences such as fatigue, sleep disturbances, emotional distress, cognitive impairment and reduced physical activity. Some hypnosis-based psychological interventions showed positive effects on fatigue, sleep and emotional distress, but generally focused on breast cancer patients. Our study aimed at assessing the effects of a group intervention combining self-care and self-hypnosis on quality of life of cancer patients. METHODS Our longitudinal randomized-controlled trial assessed the benefits of the intervention first on fatigue and secondly on associated symptoms (sleep, emotional distress, cognitive impairment and reduced physical activity) of post-treatment cancer patients, and investigated predictors of the evolution of fatigue. All variables were measured with questionnaires and an actigraph (for sleep and physical activity). RESULTS Ninety five women with different cancers were included in our study. Group-by-time effects were showed for fatigue, sleep, emotional distress and cognitive functioning: symptoms have improved in the intervention group compared to wait-list control group. Three predictors of the evolution of fatigue were revealed: depression, anxiety and worry. CONCLUSIONS Our group intervention had benefits for post-treatment cancer patients' quality of life. Impacting emotional distress could be important in order to decrease fatigue. Further studies are needed to replicate our results. This intervention could be easily implemented to improve quality of life of cancer patients. Registration: ClinicalTrials.gov (NCT03144154). Retrospectively registered on the 1st of May, 2017.",2020,"Group-by-time effects were showed for fatigue, sleep, emotional distress and cognitive functioning: symptoms have improved in the intervention group compared to wait-list control group.","['post-treatment cancer patients', '95 women with different cancers', 'breast cancer patients', 'cancer patients']","['intervention combining self-care and self-hypnosis', 'group intervention combining self-care and self-hypnosis']","['fatigue and associated symptoms', 'questionnaires and an actigraph (for sleep and physical activity', 'quality of life of cancer patients', 'associated symptoms (sleep, emotional distress, cognitive impairment and reduced physical activity', 'fatigue, sleep, emotional distress and cognitive functioning: symptoms', 'fatigue, sleep and emotional distress', 'quality of life', 'depression, anxiety, and worry']","[{'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0036592', 'cui_str': 'Self-care interventions'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0020587', 'cui_str': 'Hypnotherapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0521989', 'cui_str': 'Associated symptom'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0700361', 'cui_str': 'Emotional distress'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0233481', 'cui_str': 'Worried'}]",95.0,0.0905398,"Group-by-time effects were showed for fatigue, sleep, emotional distress and cognitive functioning: symptoms have improved in the intervention group compared to wait-list control group.","[{'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Grégoire', 'Affiliation': 'Faculty of Psychology, Speech therapy and Educational Sciences, and Sensation and Perception Research Group, GIGA Research, University of Liège, Liège, Belgium.'}, {'ForeName': 'Marie-Elisabeth', 'Initials': 'ME', 'LastName': 'Faymonville', 'Affiliation': 'Interdisciplinary Algology Centre, CHU Liège, and Sensation and Perception Research Group, GIGA Research, University of Liège, Liège, Belgium.'}, {'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'Vanhaudenhuyse', 'Affiliation': 'Interdisciplinary Algology Centre, CHU Liège, and Sensation and Perception Research Group, GIGA Research, University of Liège, Liège, Belgium.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Charland-Verville', 'Affiliation': 'GIGA-Consciousness, Coma Science Group & Neurology Department, University and CHU of Liège, Liège, Belgium.'}, {'ForeName': 'Guy', 'Initials': 'G', 'LastName': 'Jerusalem', 'Affiliation': 'Medical Oncology Department, CHU Liège and University of Liège, Liège, Belgium.'}, {'ForeName': 'Sylvie', 'Initials': 'S', 'LastName': 'Willems', 'Affiliation': 'Faculty of Psychology, Speech therapy and Educational Sciences, University of Liège, Liège, Belgium.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Bragard', 'Affiliation': 'Research and Continuing Education Departement, and CRIG Research Center, Haute Ecole Libre Mosane (HELMo), Liège, Belgium.'}]",Psycho-oncology,['10.1002/pon.5395'] 144,31485039,Posterior capsule opacification and Nd:YAG laser rates with two hydrophobic acrylic single-piece IOLs.,"OBJECTIVES To evaluate the development of posterior capsule opacification (PCO) and Nd:YAG capsulotomy rates following implantation of two hydrophobic acrylic IOLs. METHODS In a randomized, controlled trial, 80 patients with bilateral senile cataract were implanted with the hydrophobic acrylic single-piece intraocular Lenses (IOLs) EyeCee One in one eye and iMics1 in the other. Outcomes of 39 patients (78 eyes) were evaluated after 3 years. Automated Quantification of After-Cataract (AQUA; for PCO occurrence), visual acuity, anterior fibrosis, capsule-optic edge interaction and distance between anterior and posterior capsule IOL surface were analysed. RESULTS After a mean follow-up of 38 ± 1.95 months, Nd:YAG capsulotomy occurred at a rate of 15.4% and 46.2% in the EyeCee One and iMics1 groups, respectively (p < 0.01). Respective mean PCO scores measured by AQUA were 1.57 ± 1.63 and 2.45 ± 1.44 (p = 0.019). A distinct gap between the anterior capsule and the IOL optic was present in 89% of eyes implanted with EyeCee One and 13% of iMics1 eyes. A gap between the posterior capsule and the posterior surface of the lens was observed in 76% of EyeCee One eyes and 35% of iMics1 eyes. CONCLUSIONS Study findings suggest that PCO and Nd:YAG capsulotomy rates are significantly lower in eyes implanted with the EyeCee One IOL compared to the iMics1 IOL. Optic sharpness and lens material seem to be the decisive factors, while the stepped edge beneath the haptic junction appeared to be ineffective.",2020,A distinct gap between the anterior capsule and the IOL optic was present in 89% of eyes implanted with EyeCee One and 13% of iMics1 eyes.,"['80 patients with bilateral senile cataract', '39 patients (78 eyes) were evaluated after 3 years']","['hydrophobic acrylic single-piece intraocular Lenses (IOLs', 'hydrophobic acrylic single-piece IOLs', 'posterior capsule opacification (PCO) and Nd']","['PCO and Nd:YAG capsulotomy rates', 'Respective mean PCO scores', 'visual acuity, anterior fibrosis, capsule-optic edge interaction and distance between anterior and posterior capsule IOL surface', 'IOL optic', 'YAG capsulotomy rates', 'YAG capsulotomy']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2025430', 'cui_str': 'Senile cataract of both eyes'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0440181', 'cui_str': 'Acrylic dental material (substance)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0023319', 'cui_str': 'Lenses, Intraocular'}, {'cui': 'C1444680', 'cui_str': 'Posterior capsule opacification'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0042812', 'cui_str': 'Visual Acuity'}, {'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C4319574', 'cui_str': 'Capsule'}, {'cui': 'C0205154', 'cui_str': 'Along edge (qualifier value)'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0205148', 'cui_str': 'Surface (attribute)'}]",80.0,0.0689483,A distinct gap between the anterior capsule and the IOL optic was present in 89% of eyes implanted with EyeCee One and 13% of iMics1 eyes.,"[{'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Schartmüller', 'Affiliation': 'Department of Ophthalmology and Optometry of the Medical University of Vienna, Spitalgasse 23, 1090, Vienna, Austria.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Schriefl', 'Affiliation': 'Department of Ophthalmology and Optometry of the Medical University of Vienna, Spitalgasse 23, 1090, Vienna, Austria.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Schwarzenbacher', 'Affiliation': 'Department of Ophthalmology and Optometry of the Medical University of Vienna, Spitalgasse 23, 1090, Vienna, Austria.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Leydolt', 'Affiliation': 'Department of Ophthalmology and Optometry of the Medical University of Vienna, Spitalgasse 23, 1090, Vienna, Austria.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Kundi', 'Affiliation': 'Center for Public Health, Medical University of Vienna, Kinderspitalgasse 15, 1090, Vienna, Austria.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Pieh', 'Affiliation': 'Department of Ophthalmology and Optometry of the Medical University of Vienna, Spitalgasse 23, 1090, Vienna, Austria.'}, {'ForeName': 'Rupert', 'Initials': 'R', 'LastName': 'Menapace', 'Affiliation': 'Department of Ophthalmology and Optometry of the Medical University of Vienna, Spitalgasse 23, 1090, Vienna, Austria. rupert.menapace@meduniwien.ac.at.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Kriechbaum', 'Affiliation': 'Department of Ophthalmology and Optometry of the Medical University of Vienna, Spitalgasse 23, 1090, Vienna, Austria.'}]","Eye (London, England)",['10.1038/s41433-019-0569-x'] 145,31860566,"Design of a 3-Arm Randomized Trial for Posthysterectomy Vault Prolapse Involving Sacral Colpopexy, Transvaginal Mesh, and Native Tissue Apical Repair: The Apical Suspension Repair for Vault Prolapse in a Three-Arm Randomized Trial.","OBJECTIVE The objective of this study was to present the design of the Apical Suspension Repair for Vault Prolapse in a Three-Arm Randomized Trial (ASPIRe), which compares the efficacy and safety of 3 apical repairs: native tissue (NT) transvaginal repair, transvaginal mesh, and sacral colpopexy. METHODS Patient selection criteria, primary and secondary outcome measures including patient-reported outcome questionnaires, masking, surgeon certification, procedure standardization, adverse events collection and adjudication, and cost analysis will be described for this multi-centered randomized trial. Given the unique risks/benefits of each technique, a noninferiority design will be used to compare apical transvaginal mesh to mesh sacral colpopexy. A superiority design will be used to compare the 2 mesh repairs to NT transvaginal apical repair. Survival analysis will be used to assess a composite primary outcome for success composed of a subjective measure (no prolapse symptoms), objective measure (no prolapse beyond the hymen), and no prolapse retreatment, with a minimum follow-up of 36 months. Secondary outcome measures collected every 6 months include assessment of validated general and condition-specific quality of life measures, global impression of improvement, satisfaction and regret, body image, and sexual function. RESULTS Randomization and surgical treatment of 360 participants are complete, and the study is in the follow-up phase. CONCLUSIONS This report will provide valuable insight on the design of a novel 3-arm surgical trial using mesh versus NT to repair vaginal vault prolapse. This trial will provide level 1 evidence on the risks and benefits of mesh augmented versus NT apical repairs.",2020,This report will provide valuable insight on the design of a novel 3-arm surgical trial using mesh versus NT to repair vaginal vault prolapse.,['360 participants'],"['Posthysterectomy Vault Prolapse Involving Sacral Colpopexy, Transvaginal Mesh, and Native Tissue Apical Repair', 'NT transvaginal apical repair', 'NT', 'Apical Suspension Repair', '3 apical repairs: native tissue (NT) transvaginal repair, transvaginal mesh, and sacral colpopexy']","['patient-reported outcome questionnaires, masking, surgeon certification, procedure standardization, adverse events collection and adjudication, and cost analysis', 'efficacy and safety', 'assessment of validated general and condition-specific quality of life measures, global impression of improvement, satisfaction and regret, body image, and sexual function']","[{'cui': 'C4319607', 'cui_str': '360 (qualifier value)'}]","[{'cui': 'C0033377', 'cui_str': 'Prolapse'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C1536162', 'cui_str': 'Sacral colpopexy'}, {'cui': 'C0175672', 'cui_str': 'Vaginal approach (qualifier value)'}, {'cui': 'C0181805', 'cui_str': 'Mesh (physical object)'}, {'cui': 'C0302891', 'cui_str': 'Native (qualifier value)'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C0205111', 'cui_str': 'Apical (qualifier value)'}, {'cui': 'C0374711', 'cui_str': 'Surgical repair (procedure)'}, {'cui': 'C1382107', 'cui_str': 'Suspension'}]","[{'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0582175', 'cui_str': 'Surgeon (occupation)'}, {'cui': 'C0007836', 'cui_str': 'Certification'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0038136', 'cui_str': 'Standardization'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0600644', 'cui_str': 'Collection'}, {'cui': 'C0010171', 'cui_str': 'Cost Analysis'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0034380'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0080101', 'cui_str': 'Regret'}, {'cui': 'C0005891', 'cui_str': 'Body Image'}, {'cui': 'C0278092', 'cui_str': 'Sexual function (observable entity)'}]",360.0,0.177031,This report will provide valuable insight on the design of a novel 3-arm surgical trial using mesh versus NT to repair vaginal vault prolapse.,"[{'ForeName': 'Shawn', 'Initials': 'S', 'LastName': 'Menefee', 'Affiliation': 'From the Division of Female Pelvic Medicine and Reconstructive Surgery, Department of Obstetrics and Gynecology, Kaiser Permanente San Diego, San Diego, CA.'}, {'ForeName': 'Holly E', 'Initials': 'HE', 'LastName': 'Richter', 'Affiliation': 'Division of Urogynecology and Pelvic Reconstructive Surgery, Department of Obstetrics and Gynecology, University of Alabama at Birmingham, Birmingham, AL.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Myers', 'Affiliation': 'Division of Urogynecology and Reconstructive Pelvic Surgery, Department of Obstetrics and Gynecology, Brown University, Providence, RI.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Weidner', 'Affiliation': 'Division of Urogynecology, Department of Obstetrics and Gynecology, Duke University Medical Center, Durham, NC.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Moalli', 'Affiliation': ""Women's Center for Bladder and Pelvic Health, Division of Urogynecology and Reconstructive Pelvic Surgery, Department of Obstetrics, Gynecology and Reproductive Sciences, University of Pittsburgh Medical Center, Pittsburgh.""}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Harvie', 'Affiliation': 'Division of Urogynecology and Pelvic Reconstructive Surgery, Department of Obstetrics and Gynecology, University of Pennsylvania Health System, Philadelphia, PA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Rahn', 'Affiliation': 'Division of Female Pelvic Medicine and Reconstructive Surgery, University of Texas, Southwestern, Dallas, TX.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Jeppson', 'Affiliation': 'Division of Urogynecology, Department of Obstetrics and Gynecology, University of New.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Paraiso', 'Affiliation': ""Center for Urogynecology and Reconstructive Pelvic Surgery, Obstetrics, Gynecology and Women's Health Institute, Cleveland Clinic, Cleveland, OH.""}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Thomas', 'Affiliation': 'RTI International, Research Triangle Park, NC.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Mazloomdoost', 'Affiliation': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, MD.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Female pelvic medicine & reconstructive surgery,['10.1097/SPV.0000000000000803'] 146,32272389,Heterogeneous peer effects on marijuana use: Evidence from a natural experiment.,"Causal peer influence on marijuana use is difficult to identify, largely due to selection-marijuana users tend to select marijuana users to be friends. This study takes advantage of a natural experiment of randomly assigned college roommates (n = 1953) in the United States to investigate peer influence on marijuana use. The randomized roommate assignment eliminates selection bias. Compared to behaviors such as drinking and smoking, marijuana use is less legally and socially acceptable. Therefore, peer influence on marijuana use may not be pervasive. To identify the potential peer effects, we considered both heterogeneity in respondents and heterogeneity in peers. We found that peer influence depended on respondent's predisposition to marijuana use. Results showed that peer effects only existed among those who used marijuana before college. For respondents who did not use marijuana before college, monthly marijuana use in college was close to zero and no peer effect was found. Further analysis revealed that marijuana use was contingent on roommate's history of marijuana use. For respondents who used marijuana before college, their college marijuana use decreased substantially if they were assigned roommates who desisted from using marijuana (i.e., used marijuana before college but stopped using in college) than if they were assigned roommates who never used marijuana, always used, or started using after entering college.",2020,"For respondents who did not use marijuana before college, monthly marijuana use in college was close to zero and no peer effect was found.","['For respondents who used marijuana before college, their college marijuana use decreased substantially if they were assigned roommates who desisted from using marijuana (i.e., used marijuana before college but stopped using in college) than if they were assigned roommates who never used marijuana, always used, or started using after entering college', 'randomly assigned college roommates (n\xa0=\xa01953) in the United States to investigate peer influence on marijuana use', 'For respondents who did not use marijuana before college, monthly marijuana use in college']",[],[],"[{'cui': 'C0282122', 'cui_str': 'Respondents'}, {'cui': 'C0024810', 'cui_str': 'Marihuana Smoking'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0450446', 'cui_str': 'Stops'}, {'cui': 'C2003901', 'cui_str': 'Never'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C1522196', 'cui_str': 'Enteral route'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C1292732', 'cui_str': 'Investigates'}, {'cui': 'C0683549', 'cui_str': 'Peer Influence'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]",[],[],,0.0194397,"For respondents who did not use marijuana before college, monthly marijuana use in college was close to zero and no peer effect was found.","[{'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Sociology, University of Macau, Macau, China. Electronic address: yili@um.mo.edu.'}, {'ForeName': 'Guang', 'Initials': 'G', 'LastName': 'Guo', 'Affiliation': 'Department of Sociology, University of North Carolina at Chapel Hill, USA; Carolina Population Center, University of North Carolina at Chapel Hill, USA; Carolina Center for Genome Sciences, University of North Carolina at Chapel Hill, USA.'}]",Social science & medicine (1982),['10.1016/j.socscimed.2020.112907'] 147,31666688,"Inhaled nitric oxide as an adjunct to neonatal resuscitation in premature infants: a pilot, double blind, randomized controlled trial.","BACKGROUND Nitric oxide (NO) plays an important role in normal postnatal transition. Our aims were to determine whether adding inhaled NO (iNO) decreases supplemental oxygen exposure in preterm infants requiring positive pressure ventilation (PPV) during resuscitation and to study iNO effects on heart rate (HR), oxygen saturation (SpO 2 ), and need for intubation during the first 20 min of life. METHODS This was a pilot, double-blind, randomized, placebo-controlled trial. Infants 25 0/7-31 6/7 weeks' gestational age requiring PPV with supplemental oxygen during resuscitation were enrolled. PPV was initiated with either oxygen (FiO 2 -0.30) + iNO at 20 ppm (iNO group) or oxygen (FiO 2 -0.30) + nitrogen (placebo group). Oxygen was titrated targeting defined SpO 2 per current guidelines. After 10 min, iNO/nitrogen was weaned stepwise per protocol and terminated at 17 min. RESULTS Twenty-eight infants were studied (14 per group). The mean gestational age in both groups was similar. Cumulative FiO 2 and rate of exposure to high FiO 2 (>0.60) were significantly lower in the iNO group. There were no differences in HR, SpO 2 , and need for intubation. CONCLUSIONS Administration of iNO as an adjunct during neonatal resuscitation is feasible without side effects. It diminishes exposure to high levels of supplemental oxygen.",2020,Cumulative FiO 2 and rate of exposure to high FiO 2 (>0.60) were significantly lower in the iNO group.,"['premature infants', 'preterm infants requiring positive pressure ventilation (PPV', ""Infants 25 0/7-31 6/7 weeks' gestational age requiring PPV with supplemental oxygen during resuscitation were enrolled""]","['placebo', 'inhaled NO (iNO', 'Inhaled nitric oxide', 'oxygen (FiO 2 -0.30)\u2009+\u2009iNO at 20\u2009ppm (iNO group) or oxygen (FiO 2 -0.30)\u2009+\u2009nitrogen (placebo']","['mean gestational age', 'heart rate (HR), oxygen saturation (SpO 2 ), and need for intubation', 'Cumulative FiO 2 and rate of exposure to high FiO 2', 'HR, SpO 2 , and need for intubation']","[{'cui': 'C4048294', 'cui_str': 'Preterm Infant'}, {'cui': 'C3266857', 'cui_str': 'Positive-Pressure Ventilation'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0017504', 'cui_str': 'Fetal Maturity, Chronologic'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0035273', 'cui_str': 'Resuscitation'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0004048', 'cui_str': 'Inhalation'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0439187', 'cui_str': 'parts per million'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0028158', 'cui_str': 'Nitrogen'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0017504', 'cui_str': 'Fetal Maturity, Chronologic'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0523807', 'cui_str': 'Oximetry'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0332157', 'cui_str': 'Exposure to (contextual qualifier) (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]",28.0,0.552969,Cumulative FiO 2 and rate of exposure to high FiO 2 (>0.60) were significantly lower in the iNO group.,"[{'ForeName': 'Krishnamurthy', 'Initials': 'K', 'LastName': 'Sekar', 'Affiliation': 'Neonatal Perinatal Section, Department of Pediatrics, University of Oklahoma Health Sciences Center, Oklahoma City, OK, USA. Kris-Sekar@ouhsc.edu.'}, {'ForeName': 'Edgardo', 'Initials': 'E', 'LastName': 'Szyld', 'Affiliation': 'Neonatal Perinatal Section, Department of Pediatrics, University of Oklahoma Health Sciences Center, Oklahoma City, OK, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'McCoy', 'Affiliation': 'Neonatal Perinatal Section, Department of Pediatrics, University of Oklahoma Health Sciences Center, Oklahoma City, OK, USA.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Wlodaver', 'Affiliation': 'Neonatal Perinatal Section, Department of Pediatrics, University of Oklahoma Health Sciences Center, Oklahoma City, OK, USA.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Dannaway', 'Affiliation': 'Neonatal Perinatal Section, Department of Pediatrics, University of Oklahoma Health Sciences Center, Oklahoma City, OK, USA.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Helmbrecht', 'Affiliation': 'Neonatal Perinatal Section, Department of Pediatrics, University of Oklahoma Health Sciences Center, Oklahoma City, OK, USA.'}, {'ForeName': 'Julee', 'Initials': 'J', 'LastName': 'Riley', 'Affiliation': 'Neonatal Perinatal Section, Department of Pediatrics, University of Oklahoma Health Sciences Center, Oklahoma City, OK, USA.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Manfredo', 'Affiliation': 'Neonatal Perinatal Section, Department of Pediatrics, University of Oklahoma Health Sciences Center, Oklahoma City, OK, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Anderson', 'Affiliation': 'Neonatal Perinatal Section, Department of Pediatrics, University of Oklahoma Health Sciences Center, Oklahoma City, OK, USA.'}, {'ForeName': 'Satyan', 'Initials': 'S', 'LastName': 'Lakshminrusimha', 'Affiliation': 'Department of Pediatrics, UC Davis Health, Sacramento, CA, USA.'}, {'ForeName': 'Shahab', 'Initials': 'S', 'LastName': 'Noori', 'Affiliation': ""Fetal and Neonatal Institute, Division of Neonatology, Children's Hospital of Los Angeles, Department of Pediatrics, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.""}]",Pediatric research,['10.1038/s41390-019-0643-x'] 148,32302347,"Clinical impact of melatonin on breast cancer patients undergoing chemotherapy; effects on cognition, sleep and depressive symptoms: A randomized, double-blind, placebo-controlled trial.","This randomized, double-blinded, placebo-controlled trial tested the hypothesis that 20mg of melatonin before and during the first cycle of adjuvant chemotherapy for breast cancer (ACBC) reduced the side effects associated with cognitive impairment. We evaluated the effects of melatonin on cognition, depressive symptoms and sleep quality, and whether these effects were related to serum levels of Brain Derived Neurotrophic Factor (BDNF) and its receptor, tropomyosin kinase B (TrkB). Thirty-six women were randomly assigned to receive melatonin or placebo for 10 days. To evaluate cognitive performance, we used the Trail-Making-Test Parts A and B (A-B), Rey Auditory-Verbal Learning Test (RAVLT), Controlled Oral Word Association Test (COWAT) and an inhibitory task type Go / No-Go. Our results revealed that melatonin improved executive function on TMT scores, enhanced episodic memory (immediate and delayed) and recognition on RAVLT, and increased verbal fluency in the orthographic COWAT. The TMT-A-B(A-B) were negatively correlated with baseline levels of TrkB and BDNF, respectively. At the end of treatment, changes in TrkB and BDNF were inversely associated with depressive symptoms and sleep quality, but not with the TMT scores. These results suggest a neuroprotective effect of melatonin to counteract the adverse effects of ACBC on cognitive function, sleep quality and depressive symptoms.",2020,"Our results revealed that melatonin improved executive function on TMT scores, enhanced episodic memory (immediate and delayed) and recognition on RAVLT, and increased verbal fluency in the orthographic COWAT.","['Thirty-six women', 'breast cancer (ACBC', 'breast cancer patients undergoing']","['melatonin or placebo', 'Trail-Making-Test Parts A and B (A-B), Rey Auditory-Verbal Learning Test (RAVLT), Controlled Oral Word Association Test (COWAT) and an inhibitory task type', 'placebo', 'chemotherapy', 'melatonin']","['cognitive function, sleep quality and depressive symptoms', 'executive function on TMT scores, enhanced episodic memory (immediate and delayed) and recognition on RAVLT, and increased verbal fluency', 'cognition, depressive symptoms and sleep quality', 'depressive symptoms and sleep quality', 'changes in TrkB and BDNF', 'cognition, sleep and depressive symptoms', 'serum levels of Brain Derived Neurotrophic Factor (BDNF) and its receptor, tropomyosin kinase B (TrkB']","[{'cui': 'C4319606', 'cui_str': '36'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0025219', 'cui_str': 'Melatonin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0385242', 'cui_str': 'Apo-2 Ligand'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0449719', 'cui_str': 'Part'}, {'cui': 'C4505058', 'cui_str': 'Rey Auditory Verbal Learning Test'}, {'cui': 'C3827022', 'cui_str': 'Controlled Oral Word Association Test'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0040604', 'cui_str': 'Trail making test'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0561843', 'cui_str': 'Episodic memory'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0524637', 'cui_str': 'Recognition'}, {'cui': 'C4505058', 'cui_str': 'Rey Auditory Verbal Learning Test'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0077397', 'cui_str': 'Tropomyosin kinase'}, {'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",36.0,0.466551,"Our results revealed that melatonin improved executive function on TMT scores, enhanced episodic memory (immediate and delayed) and recognition on RAVLT, and increased verbal fluency in the orthographic COWAT.","[{'ForeName': 'Ana Claudia Souza', 'Initials': 'ACS', 'LastName': 'Palmer', 'Affiliation': 'Department of Pharmacology, Universidade Federal do Rio Grande do Sul (UFRGS), Porto Alegre, RS, Brazil.'}, {'ForeName': 'Maxciel', 'Initials': 'M', 'LastName': 'Zortea', 'Affiliation': 'School of Medicine, Universidade Federal do Rio Grande do Sul (UFRGS), Porto Alegre, RS, Brazil.'}, {'ForeName': 'Andressa', 'Initials': 'A', 'LastName': 'Souza', 'Affiliation': 'La Salle University Center, Canoas, RS, Brazil.'}, {'ForeName': 'Vinicius', 'Initials': 'V', 'LastName': 'Santos', 'Affiliation': 'School of Medicine, Universidade Federal do Rio Grande do Sul (UFRGS), Porto Alegre, RS, Brazil.'}, {'ForeName': 'Jorge Villanova', 'Initials': 'JV', 'LastName': 'Biazús', 'Affiliation': 'Division of Breast Surgery, Hospital de Clinicas de Porto Alegre (HCPA), Post-graduate Program in Gynecology and Obstetrics, Universidade Federal do Rio Grande do Sul (UFRGS), Porto Alegre, RS, Brazil.'}, {'ForeName': 'Iraci L S', 'Initials': 'ILS', 'LastName': 'Torres', 'Affiliation': 'Department of Pharmacology, Universidade Federal do Rio Grande do Sul (UFRGS), Porto Alegre, RS, Brazil.'}, {'ForeName': 'Felipe', 'Initials': 'F', 'LastName': 'Fregni', 'Affiliation': 'Spaulding Neuromodulation Center, Spaulding Rehabilitation Hospital, Harvard Medical School, Boston, MA, United States of America.'}, {'ForeName': 'Wolnei', 'Initials': 'W', 'LastName': 'Caumo', 'Affiliation': 'Department of Pharmacology, Universidade Federal do Rio Grande do Sul (UFRGS), Porto Alegre, RS, Brazil.'}]",PloS one,['10.1371/journal.pone.0231379'] 149,32275653,"The impact of insecticide treated curtains on dengue virus transmission: A cluster randomized trial in Iquitos, Peru.","Dengue is one of the most important vector-borne diseases, resulting in an estimated hundreds of millions of infections annually throughout the tropics. Control of dengue is heavily dependent upon control of its primary mosquito vector, Aedes aegypti. Innovative interventions that are effective at targeting the adult stage of the mosquito are needed to increase the options for effective control. The use of insecticide-treated curtains (ITCs) has previously been shown to significantly reduce the abundance of Ae. aegypti in and around homes, but the impact of ITCs on dengue virus (DENV) transmission has not been rigorously quantified. A parallel arm cluster-randomized controlled trial was conducted in Iquitos, Peru to quantify the impact of ITCs on DENV seroconversion as measured through plaque-reduction neutralization tests. Seroconversion data showed that individuals living in the clusters that received ITCs were at greater risk to seroconverting to DENV, with an average seroconversion rate of 50.6 per 100 person-years (PY) (CI: 29.9-71.9), while those in the control arm had an average seroconversion rate of 37.4 per 100 PY (CI: 15.2-51.7). ITCs lost their insecticidal efficacy within 6 months of deployment, necessitating re-treatment with insecticide. Entomological indicators did not show statistically significant differences between ITC and non-ITC clusters. It's unclear how the lack of protective efficacy reported here is attributable to simple failure of the intervention to protect against Ae. aegypti bites, or the presence of a faulty intervention during much of the follow-up period. The higher risk of dengue seroconversion that was detected in the ITC clusters may have arisen due to a false sense of security that inadvertently led to less routine protective behaviors on the part of households that received the ITCs. Our study provides important lessons learned for conducting cluster randomized trials for vector control interventions against Aedes-transmitted virus infections.",2020,"Seroconversion data showed that individuals living in the clusters that received ITCs were at greater risk to seroconverting to DENV, with an average seroconversion rate of 50.6 per 100 person-years (PY) (CI: 29.9-71.9), while those in the control arm had an average seroconversion rate of 37.4 per 100 PY (CI: 15.2-51.7).",[],['insecticide-treated curtains (ITCs'],['average seroconversion rate'],[],"[{'cui': 'C0021576', 'cui_str': 'Insecticide'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0180239', 'cui_str': 'Curtain'}]","[{'cui': 'C4042908', 'cui_str': 'Seroconversion'}]",,0.0895834,"Seroconversion data showed that individuals living in the clusters that received ITCs were at greater risk to seroconverting to DENV, with an average seroconversion rate of 50.6 per 100 person-years (PY) (CI: 29.9-71.9), while those in the control arm had an average seroconversion rate of 37.4 per 100 PY (CI: 15.2-51.7).","[{'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'Lenhart', 'Affiliation': 'Vector Biology Department, Liverpool School of Tropical Medicine, Liverpool, United Kingdom.'}, {'ForeName': 'Amy C', 'Initials': 'AC', 'LastName': 'Morrison', 'Affiliation': 'Department of Pathology, Microbiology, and Immunology, School of Veterinary Medicine, University of California, Davis, California, United States of America.'}, {'ForeName': 'Valerie A', 'Initials': 'VA', 'LastName': 'Paz-Soldan', 'Affiliation': 'Department of Global Community Health and Behavioral Sciences, Tulane School of Public Health and Tropical Medicine, New Orleans, Louisiana, United States of America.'}, {'ForeName': 'Brett M', 'Initials': 'BM', 'LastName': 'Forshey', 'Affiliation': 'Department of Virology, U.S. Naval Medical Research Unit-6, Lima and Iquitos, Peru.'}, {'ForeName': 'Jhonny J', 'Initials': 'JJ', 'LastName': 'Cordova-Lopez', 'Affiliation': 'Department of Pathology, Microbiology, and Immunology, School of Veterinary Medicine, University of California, Davis, California, United States of America.'}, {'ForeName': 'Helvio', 'Initials': 'H', 'LastName': 'Astete', 'Affiliation': 'Department of Virology, U.S. Naval Medical Research Unit-6, Lima and Iquitos, Peru.'}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Elder', 'Affiliation': 'San Diego State University, San Diego, California, United States of America.'}, {'ForeName': 'Moises', 'Initials': 'M', 'LastName': 'Sihuincha', 'Affiliation': 'Director, Department of Internal Medicine, Hospital de Apoyo Iquitos, Peru.'}, {'ForeName': 'Esther E', 'Initials': 'EE', 'LastName': 'Gotlieb', 'Affiliation': 'Department of Global Community Health and Behavioral Sciences, Tulane School of Public Health and Tropical Medicine, New Orleans, Louisiana, United States of America.'}, {'ForeName': 'Eric S', 'Initials': 'ES', 'LastName': 'Halsey', 'Affiliation': 'Department of Virology, U.S. Naval Medical Research Unit-6, Lima and Iquitos, Peru.'}, {'ForeName': 'Tadeusz J', 'Initials': 'TJ', 'LastName': 'Kochel', 'Affiliation': 'Department of Virology, U.S. Naval Medical Research Unit-6, Lima and Iquitos, Peru.'}, {'ForeName': 'Thomas W', 'Initials': 'TW', 'LastName': 'Scott', 'Affiliation': 'Department of Entomology and Nematology, University of California, Davis, California, United States of America.'}, {'ForeName': 'Neal', 'Initials': 'N', 'LastName': 'Alexander', 'Affiliation': 'MRC Tropical Epidemiology Group, London School of Hygiene & Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Philip J', 'Initials': 'PJ', 'LastName': 'McCall', 'Affiliation': 'Vector Biology Department, Liverpool School of Tropical Medicine, Liverpool, United Kingdom.'}]",PLoS neglected tropical diseases,['10.1371/journal.pntd.0008097'] 150,30768418,A Randomized Controlled Trial: Attachment-Based Family and Nondirective Supportive Treatments for Youth Who Are Suicidal.,"OBJECTIVE To evaluate the efficacy of attachment-based family therapy (ABFT) compared with a family-enhanced nondirective supportive therapy (FE-NST) for decreasing adolescents' suicide ideation and depressive symptoms. METHOD A randomized controlled trial of 129 adolescents who are suicidal ages 12- to 18-years-old (49% were African American) were randomized to ABFT (n = 66) or FE-NST (n = 63) for 16 weeks of treatment. Assessments occurred at baseline and 4, 8, 12, and 16 weeks. Trajectory of change and clinical recovery were calculated for suicidal ideation and depressive symptoms. RESULTS There was no significant between-group difference in the rate of change in self-reported ideation (Suicidal Ideation Questionnaire-Jr; F 1,127  = 181, p = .18). Similar results were found for depressive symptoms. However, adolescents receiving ABFT showed a significant decrease in suicide ideation (t 127  = 12.61, p < .0001; effect size, d = 2.24). Adolescents receiving FE-NST showed a similar significant decrease (t 127  = 10.88, p < .0001; effect size, d = 1.93). Response rates (ie, ≥50% decrease in suicide ideation symptoms from baseline) at post-treatment were 69.1% for ABFT versus 62.3% for FE-NST. CONCLUSION Contrary to expectations, ABFT did not perform better than FE-NST. The 2 treatments produced substantial decreases in suicidal ideation and depressive symptoms that were comparable to or better than those reported in other more intensive, multicomponent treatments. The equivalent outcomes could be attributed to common treatment elements, different active mechanisms, or regression to the mean. Future studies will explore long-term follow up, secondary outcomes, and potential moderators and mediators. CLINICAL TRIAL REGISTRATION INFORMATION Attachment-Based Family Therapy for Suicidal Adolescents; http://clinicaltrials.gov; NCT01537419.",2019,"Adolescents receiving FE-NST showed a similar significant decrease (t 127  = 10.88, p < .0001; effect size, d = 1.93).","['129 adolescents who are suicidal ages', ""adolescents' suicide ideation and depressive symptoms"", 'Youth', '12- to 18-years-old (49% were African American']","['family-enhanced nondirective supportive therapy (FE-NST', 'FE-NST', 'ABFT', 'attachment-based family therapy (ABFT']","['Response rates', 'suicidal ideation and depressive symptoms', 'depressive symptoms', 'suicide ideation symptoms', 'suicide ideation', 'rate of change in self-reported ideation (Suicidal Ideation Questionnaire']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0438696', 'cui_str': 'Suicidal (finding)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0852733', 'cui_str': 'Suicide (accomplished)'}, {'cui': 'C0392348', 'cui_str': 'Ideation, function (observable entity)'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}]","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0015618', 'cui_str': 'Family Therapy'}]","[{'cui': 'C0424000', 'cui_str': 'Suicidal Ideation'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0852733', 'cui_str': 'Suicide (accomplished)'}, {'cui': 'C0392348', 'cui_str': 'Ideation, function (observable entity)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",129.0,0.263649,"Adolescents receiving FE-NST showed a similar significant decrease (t 127  = 10.88, p < .0001; effect size, d = 1.93).","[{'ForeName': 'Guy S', 'Initials': 'GS', 'LastName': 'Diamond', 'Affiliation': 'Center for Family Intervention Science, Drexel University, Philadelphia, PA. Electronic address: guy.diamond@drexel.edu.'}, {'ForeName': 'R Roger', 'Initials': 'RR', 'LastName': 'Kobak', 'Affiliation': 'University of Delaware, Newark.'}, {'ForeName': 'E Stephanie', 'Initials': 'ES', 'LastName': 'Krauthamer Ewing', 'Affiliation': 'Center for Family Intervention Science, Drexel University, Philadelphia, PA.'}, {'ForeName': 'Suzanne A', 'Initials': 'SA', 'LastName': 'Levy', 'Affiliation': 'Center for Family Intervention Science, Drexel University, Philadelphia, PA.'}, {'ForeName': 'Joanna L', 'Initials': 'JL', 'LastName': 'Herres', 'Affiliation': 'The College of New Jersey, Ewing Township.'}, {'ForeName': 'Jody M', 'Initials': 'JM', 'LastName': 'Russon', 'Affiliation': 'Virginia Tech, Blacksburg.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Gallop', 'Affiliation': 'Applied Statistics Program, West Chester University, PA.'}]",Journal of the American Academy of Child and Adolescent Psychiatry,['10.1016/j.jaac.2018.10.006'] 151,32321161,Evenly Distributed Protein Intake over 3 Meals Augments Resistance Exercise-Induced Muscle Hypertrophy in Healthy Young Men.,"BACKGROUND Although daily protein intake (PI) has been reported to be essential for regulating muscle mass, the distribution of daily PI in individuals is typically the lowest at breakfast and skewed toward dinner. Skewed protein intake patterns and inadequate PI at breakfast were reported to be negative factors for muscle maintenance. OBJECTIVES This study examined whether a protein-enriched meal at breakfast is more effective for muscle accretion compared with the typical skewed PI pattern. METHODS This 12-wk, parallel-group, randomized clinical trial included 26 men (means ± SEs; age: 20.8 ± 0.4 y; BMI: 21.8 ± 0.4 kg/m2). The ""high breakfast"" (HBR) group (n = 12) consumed a protein-enriched meal at breakfast providing a PI of 0.33 g/kg body weight (BW); their PI at lunch (0.46 g/kg BW) and dinner (0.48 g/kg BW) provided an adequate overall daily PI (1.30 g/kg BW/d). The ""low breakfast"" (LBR) group (n = 14) consumed 0.12 g protein/kg BW at breakfast; intakes at lunch (0.45 g/kg BW) and dinner (0.83 g/kg BW) yielded the same daily PI as in the HBR group. The participants performed supervised resistance training (RT) 3 times per week (75-80% 1-repetition maximum; 3 sets × 10 repetitions). DXA was used to measure the primary outcome variable, that is, total lean soft tissue mass (LTM). RESULTS The total LTM at baseline did not differ between the HBR (52.4 ± 1.3 kg) and LBR (53.4 ± 1.2 kg) groups. After the intervention, increases in total LTM were significant in both groups, with that in the HBR group (2.5 ± 0.3 kg) tending to be greater than that in the LBR group (1.8 ± 0.3 kg) (P = 0.06), with a large effect size (Cohen d = 0.795). CONCLUSIONS For RT-induced muscle hypertrophy in healthy young men, consuming a protein-enriched meal at breakfast and less protein at dinner while achieving an adequate overall PI is more effective than consuming more protein at dinner.This study was registered at University hospital Medical Information Network (UMIN) Clinical Trials Registry as UMIN000037583 (https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042763).",2020,The total LTM at baseline did not differ between the HBR (52.4 ± 1.3 kg) and LBR (53.4 ± 1.2 kg) groups.,"['Healthy Young Men', '26 men (means\xa0±\xa0SEs; age: 20.8\xa0±\xa00.4 y; BMI: 21.8\xa0±\xa00.4\xa0kg/m2', 'healthy young men', 'registered at University hospital Medical Information Network (UMIN']","['protein-enriched meal at breakfast', 'DXA', 'low breakfast"" (LBR', 'Evenly Distributed Protein Intake over 3 Meals Augments Resistance Exercise-Induced Muscle Hypertrophy', 'supervised resistance training (RT', 'high breakfast"" (HBR']","['total LTM', 'total lean soft tissue mass (LTM']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517457', 'cui_str': '0.4'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0021419', 'cui_str': 'Information Networks'}]","[{'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C2698559', 'cui_str': 'Breakfast time'}, {'cui': 'C1510486', 'cui_str': 'Dual energy X-ray absorptiometry'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0236033', 'cui_str': 'Muscle hypertrophy'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0205250', 'cui_str': 'High'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0457193', 'cui_str': 'Soft tissue mass'}]",26.0,0.0519553,The total LTM at baseline did not differ between the HBR (52.4 ± 1.3 kg) and LBR (53.4 ± 1.2 kg) groups.,"[{'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Yasuda', 'Affiliation': 'Faculty of Sport and Health Science, Ritsumeikan University, Nojihigashi, Kusatsu, Shiga, Japan.'}, {'ForeName': 'Toshiki', 'Initials': 'T', 'LastName': 'Tomita', 'Affiliation': 'Faculty of Sport and Health Science, Ritsumeikan University, Nojihigashi, Kusatsu, Shiga, Japan.'}, {'ForeName': 'Takuma', 'Initials': 'T', 'LastName': 'Arimitsu', 'Affiliation': 'Faculty of Sport and Health Science, Ritsumeikan University, Nojihigashi, Kusatsu, Shiga, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Fujita', 'Affiliation': 'Faculty of Sport and Health Science, Ritsumeikan University, Nojihigashi, Kusatsu, Shiga, Japan.'}]",The Journal of nutrition,['10.1093/jn/nxaa101'] 152,31248863,Quantitative Delta T1 (dT1) as a Replacement for Adjudicated Central Reader Analysis of Contrast-Enhancing Tumor Burden: A Subanalysis of the American College of Radiology Imaging Network 6677/Radiation Therapy Oncology Group 0625 Multicenter Brain Tumor Trial.,"BACKGROUND AND PURPOSE Brain tumor clinical trials requiring solid tumor assessment typically rely on the 2D manual delineation of enhancing tumors by ≥2 expert readers, a time-consuming step with poor interreader agreement. As a solution, we developed quantitative dT1 maps for the delineation of enhancing lesions. This retrospective analysis compares dT1 with 2D manual delineation of enhancing tumors acquired at 2 time points during the post therapeutic surveillance period of the American College of Radiology Imaging Network 6677/Radiation Therapy Oncology Group 0625 (ACRIN 6677/RTOG 0625) clinical trial. MATERIALS AND METHODS Patients enrolled in ACRIN 6677/RTOG 0625, a multicenter, randomized Phase II trial of bevacizumab in recurrent glioblastoma, underwent standard MR imaging before and after treatment initiation. For 123 patients from 23 institutions, both 2D manual delineation of enhancing tumors and dT1 datasets were evaluable at weeks 8 ( n = 74) and 16 ( n = 57). Using dT1, we assessed the radiologic response and progression at each time point. Percentage agreement with adjudicated 2D manual delineation of enhancing tumor reads and association between progression status and overall survival were determined. RESULTS For identification of progression, dT1 and adjudicated 2D manual delineation of enhancing tumor reads were in perfect agreement at week 8, with 73.7% agreement at week 16. Both methods showed significant differences in overall survival at each time point. When nonprogressors were further divided into responders versus nonresponders/nonprogressors, the agreement decreased to 70.3% and 52.6%, yet dT1 showed a significant difference in overall survival at week 8 ( P = .01), suggesting that dT1 may provide greater sensitivity for stratifying subpopulations. CONCLUSIONS This study shows that dT1 can predict early progression comparable with the standard method but offers the potential for substantial time and cost savings for clinical trials.",2019,"For 123 patients from 23 institutions, both 2D manual delineation of enhancing tumors and dT1 datasets were evaluable at weeks 8 ( n = 74) and 16 ( n = 57).","['Patients enrolled in ACRIN 6677/RTOG 0625', '123 patients from 23 institutions, both 2D manual delineation of enhancing tumors and dT1 datasets were evaluable at weeks 8 ( n = 74) and 16 ( n = 57', 'American College of Radiology Imaging Network']",['bevacizumab'],"['progression status and overall survival', 'Quantitative Delta T1 (dT1', 'radiologic response and progression', 'overall survival']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1272753', 'cui_str': 'Institution'}, {'cui': 'C0175674', 'cui_str': 'Manual (qualifier value)'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0150098', 'cui_str': 'Data Set'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0034599', 'cui_str': 'Radiology'}]","[{'cui': 'C0796392', 'cui_str': 'bevacizumab'}]","[{'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0392762', 'cui_str': 'Quantitative (qualifier value)'}, {'cui': 'C0439097', 'cui_str': 'Delta'}, {'cui': 'C0205483', 'cui_str': 'Radiologic (qualifier value)'}]",,0.0573702,"For 123 patients from 23 institutions, both 2D manual delineation of enhancing tumors and dT1 datasets were evaluable at weeks 8 ( n = 74) and 16 ( n = 57).","[{'ForeName': 'K M', 'Initials': 'KM', 'LastName': 'Schmainda', 'Affiliation': 'From the Departments of Biophysics (K.M.S., M.A.P.) kathleen@mcw.edu.'}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Prah', 'Affiliation': 'From the Departments of Biophysics (K.M.S., M.A.P.).'}, {'ForeName': 'Z', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Department of Biostatistics (Z.Z.).'}, {'ForeName': 'B S', 'Initials': 'BS', 'LastName': 'Snyder', 'Affiliation': 'Center for Statistical Sciences (Z.Z., B.S.S.), Brown University School of Public Health, Providence, Rhode Island.'}, {'ForeName': 'S D', 'Initials': 'SD', 'LastName': 'Rand', 'Affiliation': 'Radiology (K.M.S., S.D.R.), Medical College of Wisconsin, Milwaukee, Wisconsin.'}, {'ForeName': 'T R', 'Initials': 'TR', 'LastName': 'Jensen', 'Affiliation': 'Jensen Informatics LLC (T.R.J.), Brookfield, Wisconsin.'}, {'ForeName': 'D P', 'Initials': 'DP', 'LastName': 'Barboriak', 'Affiliation': 'Department of Radiology (D.P.B.), Duke University Medical Center, Durham, North Carolina.'}, {'ForeName': 'J L', 'Initials': 'JL', 'LastName': 'Boxerman', 'Affiliation': 'Department of Diagnostic Imaging (D.P.B., J.L.B.), Rhode Island Hospital, Providence, Rhode Island.'}]",AJNR. American journal of neuroradiology,['10.3174/ajnr.A6110'] 153,30883839,"Effects of cladribine tablets on heart rate, atrio-ventricular conduction and cardiac repolarization in patients with relapsing multiple sclerosis.","AIMS Cladribine tablets have shown significant efficacy for the treatment of relapsing multiple sclerosis, a chronic and debilitating immune-mediated disorder. This study was conducted to examine acute and/or cumulative effects of cladribine tablets 10 mg (3.5 or 5.25 mg/kg cumulative dose over 2 years) on heart rate, AV conduction and cardiac repolarization in patients with relapsing-remitting multiple sclerosis (RRMS). METHODS CLARITY was a 96-week, double-blind, placebo-controlled, multicentre trial which evaluated the safety and efficacy of cladribine tablets 3.5 and 5.25 mg/kg body weight in patients with RRMS. A total of 135 patients were included in the ECG substudy, providing a total of 1534 post-dose ECGs. ECG data were collected 15 minutes pre-dose and between 0.5 and 3 hours post-dose at pre-study evaluation, study Day 1 and Weeks 5, 9, 13, 48 and 52. RESULTS For cladribine tablets 3.5 mg/kg, the maximum change in placebo-adjusted post-dose QTcF vs. visit-baseline (BL) was -0.42 ms (90% CI: -3.61-4.44) at Week 1 (acute effects), and 3.20 ms (90% CI: -0.08-6.33) for cladribine tablets 5.25 mg/kg. The greatest observed differences in post-dose QTcF vs. study BL occurred at Week 48 for both the 3.5 and 5.25 mg/kg doses of cladribine tablets with 5.99 ms (90% CI: 0.53-11.44) and 8.74 ms (90% CI: 3.18-14.31), respectively. No significant changes were observed in T-wave morphology in either treatment group. CONCLUSIONS Cladribine tablets 3.5 mg/kg (approved dose in Europe/other regions) did not confer clinically meaningful effects on heart rate, AV conduction and ventricular repolarization.",2019,"No significant changes were observed in T-wave morphology in either treatment group. ","['patients with relapsing multiple sclerosis', 'patients with relapsing-remitting multiple sclerosis (RRMS', 'A total of 135 patients were included in the ECG substudy, providing a total of 1534 post-dose ECGs', 'patients with RRMS']","['Cladribine', 'placebo', 'cladribine', 'cladribine tablets', 'Cladribine tablets']","['heart rate, atrio-ventricular conduction and cardiac repolarization', 'heart rate, AV conduction and cardiac repolarization', 'safety and efficacy', 'heart rate, AV conduction and ventricular repolarization']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0856120', 'cui_str': 'Multiple sclerosis relapse'}, {'cui': 'C0751967', 'cui_str': 'Multiple Sclerosis, Relapsing-Remitting'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4517566', 'cui_str': '135'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1623258', 'cui_str': 'ECG'}, {'cui': 'C0439568', 'cui_str': 'Post-dose (qualifier value)'}]","[{'cui': 'C0092801', 'cui_str': 'Cladribine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}]","[{'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0457405', 'cui_str': 'Conduction (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",135.0,0.284969,"No significant changes were observed in T-wave morphology in either treatment group. ","[{'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Hermann', 'Affiliation': 'cr-appliance, Gelnhausen, Germany.'}, {'ForeName': 'Jeffrey S', 'Initials': 'JS', 'LastName': 'Litwin', 'Affiliation': 'WCG Clinical, Princeton, NJ, USA.'}, {'ForeName': 'Lena E', 'Initials': 'LE', 'LastName': 'Friberg', 'Affiliation': 'Department of Pharmaceutical Biosciences, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Dangond', 'Affiliation': 'EMD Serono Inc., Billerica, MA, USA.'}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Munafo', 'Affiliation': 'Quantitative Pharmacology, Merck Institute for Pharmacometrics, Lausanne, Switzerland.'}]",British journal of clinical pharmacology,['10.1111/bcp.13919'] 154,30883864,Pharmacokinetics and subjective effects of a novel oral LSD formulation in healthy subjects.,"AIMS The aim of the present study was to characterize the pharmacokinetics and exposure-subjective response relationship of a novel oral solution of lysergic acid diethylamide (LSD) that was developed for clinical use in research and patients. METHOD LSD (100 μg) was administered in 27 healthy subjects using a placebo-controlled, double-blind, cross-over design. Plasma levels of LSD, nor-LSD, and 2-oxo-3-hydroxy-LSD (O-H-LSD) and subjective drug effects were assessed up to 11.5 hours. RESULTS First-order elimination kinetics were observed for LSD. Geometric mean maximum concentration (C max ) values (range) of 1.7 (1.0-2.9) ng/mL were reached at a t max (range) of 1.7 (1.0-3.4) hours after drug administration. The plasma half-life (t 1/2 ) was 3.6 (2.4-7.3) hours. The AUC ∞ was 13 (7.1-28) ng·h/mL. No differences in these pharmacokinetic parameters were found between male and female subjects. Plasma O-H-LSD but not nor-LSD (< 0.01 ng/mL) concentrations could be quantified in all subjects. Geometric mean O-H-LSD C max values (range) of 0.11 (0.07-0.19) ng/mL were reached at a t max (range) of 5 (3.2-8) hours. The t 1/2 and AUC ∞ values of O-H-LSD were 5.2 (2.6-21) hours and 1.7 (0.85-4.3) ng·h/mL, respectively. The subjective effects of LSD lasted (mean ± SD) for 8.5 ± 2.0 hours (range: 5.3-12.8 h), and peak effects were reached 2.5 ± 0.6 hours (range 1.6-4.3 h) after drug administration. EC 50 values were 1.0 ± 0.5 ng/mL and 1.9 ± 1.0 ng/mL for ""good"" and ""bad"" subjective drug effects, respectively. CONCLUSION The present study characterized the pharmacokinetics of LSD and its main metabolite O-H-LSD. The subjective effects of LSD were closely associated with changes in plasma concentrations over time.",2019,Plasma O-H-LSD but not nor-LSD (< 0.01 ,"['male and female subjects', 'LSD (100\xa0μg) was administered in 27 healthy subjects using a', 'healthy subjects']","['novel oral solution of lysergic acid diethylamide (LSD', 'placebo', 'novel oral LSD formulation']","['Geometric mean maximum concentration (C max ) values', 'plasma half-life', 'peak effects', 'Geometric mean O-H-LSD C max values (range', 'plasma concentrations', 'Plasma O-H-LSD', 'Plasma levels of LSD, nor-LSD, and 2-oxo-3-hydroxy-LSD (O-H-LSD) and subjective drug effects']","[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0024334', 'cui_str': 'LSD'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0991536', 'cui_str': 'Oral Solution'}, {'cui': 'C0024334', 'cui_str': 'LSD'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0018517', 'cui_str': 'Halflife'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0024334', 'cui_str': 'LSD'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1143262', 'cui_str': 'nor-LSD'}, {'cui': 'C0766594', 'cui_str': '2-oxo-3-hydroxy-lysergide'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0728867', 'cui_str': 'Drug action (finding)'}]",27.0,0.186405,Plasma O-H-LSD but not nor-LSD (< 0.01 ,"[{'ForeName': 'Friederike', 'Initials': 'F', 'LastName': 'Holze', 'Affiliation': 'Division of Clinical Pharmacology and Toxicology, Department of Biomedicine and Department of Clinical Research, University Hospital Basel, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Urs', 'Initials': 'U', 'LastName': 'Duthaler', 'Affiliation': 'Division of Clinical Pharmacology and Toxicology, Department of Biomedicine and Department of Clinical Research, University Hospital Basel, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Vizeli', 'Affiliation': 'Division of Clinical Pharmacology and Toxicology, Department of Biomedicine and Department of Clinical Research, University Hospital Basel, University of Basel, Basel, Switzerland.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Müller', 'Affiliation': 'Department of Psychiatry (UPK), University of Basel, Basel, Switzerland.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Borgwardt', 'Affiliation': 'Department of Psychiatry (UPK), University of Basel, Basel, Switzerland.'}, {'ForeName': 'Matthias E', 'Initials': 'ME', 'LastName': 'Liechti', 'Affiliation': 'Division of Clinical Pharmacology and Toxicology, Department of Biomedicine and Department of Clinical Research, University Hospital Basel, University of Basel, Basel, Switzerland.'}]",British journal of clinical pharmacology,['10.1111/bcp.13918'] 155,31707465,"Relationship between P1NP, a biochemical marker of bone turnover, and bone mineral density in patients transitioned from alendronate to romosozumab or teriparatide: a post hoc analysis of the STRUCTURE trial.","INTRODUCTION Procollagen type I N-terminal propeptide (P1NP), a bone formation marker, reportedly predicts bone mineral density (BMD) response to teriparatide treatment in treatment-naive patients with osteoporosis. Results from a randomized, phase 3, open-label, active-controlled trial- STRUCTURE-showed that in patients previously treated with bisphosphonates, romosozumab led to gains in hip BMD, which were not observed with teriparatide. This post hoc analysis investigated the comparative utility of early changes in P1NP in predicting BMD response in patients who participated in the STRUCTURE trial, which enrolled patients who switched treatment from bisphosphonates to romosozumab/teriparatide. MATERIALS AND METHODS Postmenopausal women (aged 55-90 years) with osteoporosis who had previously taken bisphosphonates were randomized to receive open-label subcutaneous romosozumab (210 mg once monthly; n = 218) or teriparatide (20 µg once daily; n = 218) for 12 months. BMD was assessed by dual-energy X-ray absorptiometry at the proximal femur and lumbar spine (LS) at baseline and months 6 and 12. To assess the utility of P1NP, the positive predictive value of increase from baseline in P1NP of > 10 µg/L at month 1 and achievement of various thresholds of percent change from baseline in BMD at month 12 were evaluated. RESULTS Overall, 95% (191/202) of patients in the romosozumab group and 91% (183/201) in the teriparatide group demonstrated an increase in P1NP of > 10 µg/L from baseline at month 1. Among these patients, 18% and 3% of romosozumab-treated patients versus 60% and 12% of teriparatide-treated patients showed no increase from baseline (i.e., ≤ 0%) in total hip and LS BMD, respectively, at month 12. These data indicate that in patients switching from bisphosphonates to a bone-forming therapy, increases in P1NP do not help predict the hip BMD response. Although most patients treated with either teriparatide or romosozumab showed an increase in P1NP, the majority of patients on romosozumab showed an increase in hip BMD, while more than half of the patients on teriparatide did not. Teriparatide therapy did not increase total hip BMD in the majority of patients who transitioned from bisphosphonates to teriparatide. CONCLUSIONS Thus, increases in P1NP were not predictive of BMD response in the teriparatide group because in approximately 60% of the patients who were administered teriparatide, the hip BMD decreased independent of the change in P1NP levels.",2020,"Teriparatide therapy did not increase total hip BMD in the majority of patients who transitioned from bisphosphonates to teriparatide. ","['patients who participated in the STRUCTURE trial, which enrolled patients who switched treatment from bisphosphonates to romosozumab/teriparatide', 'patients transitioned from', 'treatment-naive patients with osteoporosis', 'P1NP of\u2009>\u200910', 'Postmenopausal women (aged 55-90\xa0years) with osteoporosis who had previously taken bisphosphonates']","['open-label subcutaneous romosozumab', 'alendronate to romosozumab or teriparatide', 'bisphosphonates, romosozumab', 'teriparatide', 'Teriparatide therapy', 'teriparatide or romosozumab']","['P1NP', 'total hip BMD', 'BMD', 'hip BMD', 'BMD response', 'bone turnover, and bone mineral density', 'bone mineral density (BMD) response', 'P1NP levels', 'hip BMD response']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0012544', 'cui_str': 'Bisphosphonates'}, {'cui': 'C3661283'}, {'cui': 'C0070093', 'cui_str': 'Teriparatide'}, {'cui': 'C4019079', 'cui_str': 'Care Transition'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1515187', 'cui_str': 'Take'}]","[{'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C1522438', 'cui_str': 'SC use'}, {'cui': 'C3661283'}, {'cui': 'C0102118', 'cui_str': 'Alendronate'}, {'cui': 'C0070093', 'cui_str': 'Teriparatide'}, {'cui': 'C0012544', 'cui_str': 'Bisphosphonates'}, {'cui': 'C1562708', 'cui_str': 'Teriparatide therapy'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0085268', 'cui_str': 'Bone Turnover'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",,0.0457693,"Teriparatide therapy did not increase total hip BMD in the majority of patients who transitioned from bisphosphonates to teriparatide. ","[{'ForeName': 'Junichi', 'Initials': 'J', 'LastName': 'Takada', 'Affiliation': 'Kitago Orthopedic Clinic, Hokkaido, Japan. jtakada@kitago-ortho.com.'}, {'ForeName': 'Rajani', 'Initials': 'R', 'LastName': 'Dinavahi', 'Affiliation': 'Amgen Inc., Thousand Oaks, CA, USA.'}, {'ForeName': 'Akimitsu', 'Initials': 'A', 'LastName': 'Miyauchi', 'Affiliation': 'Miyauchi Medical Center, Osaka, Japan.'}, {'ForeName': 'Etsuro', 'Initials': 'E', 'LastName': 'Hamaya', 'Affiliation': 'Amgen Astellas BioPharma K.K., Tokyo, Japan.'}, {'ForeName': 'Toshiyasu', 'Initials': 'T', 'LastName': 'Hirama', 'Affiliation': 'Amgen Astellas BioPharma K.K., Tokyo, Japan.'}, {'ForeName': 'Cesar', 'Initials': 'C', 'LastName': 'Libanati', 'Affiliation': 'UCB Pharma, Brussels, Belgium.'}, {'ForeName': 'Yoichi', 'Initials': 'Y', 'LastName': 'Nakamura', 'Affiliation': 'Amgen Astellas BioPharma K.K., Tokyo, Japan.'}, {'ForeName': 'Cassandra E', 'Initials': 'CE', 'LastName': 'Milmont', 'Affiliation': 'Amgen Inc., Thousand Oaks, CA, USA.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Grauer', 'Affiliation': 'Amgen Inc., Thousand Oaks, CA, USA.'}]",Journal of bone and mineral metabolism,['10.1007/s00774-019-01057-1'] 156,31897748,Effects of whole-body vibration and high impact exercises on the bone metabolism and functional mobility in postmenopausal women.,"INTRODUCTION This study determined the effects of whole-body vibration (WBV) and high-impact exercises on postmenopausal women. MATERIALS AND METHODS In this randomized controlled 6-month interventional trial, 58 eligible postmenopausal women were assigned to WBV training group, high-impact training group, or control group. Bone mineral density (BMD) of the lumbar spine and femur were measured by dual-energy X-ray absorptiometry. Additionally, the serum osteocalcin (OC) and C-terminal telopeptide of type I collagen levels were also measured. The functional mobility was assessed using the Timed Up and Go (TUG) test, and fall index was measured using static posturography. The health-related quality of life (HRQoL) and depressive symptoms were assessed using the Quality of Life Questionnaire of the European Foundation for Osteoporosis and Beck Depression Inventory, respectively. RESULTS The BMD at the femoral neck (p = 0.003) and L 2 -L 4 (p = 0.005) regions increased significantly in the WBV group compared to the control group. However, in the high-impact exercise group there were no significant effects on the lumbar spine and femoral neck. The serum OC decreased significantly in the WBV group and increased significantly in both the high-impact exercise and control groups (p < 0.001). The TUG scores decreased significantly in both training groups compared to the control group (p < 0.05). Finally, in both exercise groups, HRQoL and depressive symptoms improved (p < 0.001). CONCLUSIONS Our data suggest that the WBV can prevent bone loss in postmenopausal women. These findings also indicate that WBV and high-impact training programs improve functional mobility, HRQoL and depressive symptoms in postmenopausal women.",2020,The serum OC decreased significantly in the WBV group and increased significantly in both the high-impact exercise and control groups (p < 0.001).,"['58 eligible postmenopausal women', 'postmenopausal women']","['whole-body vibration and high impact exercises', 'WBV', 'whole-body vibration (WBV) and high-impact exercises', 'WBV training group, high-impact training group, or control group']","['health-related quality of life (HRQoL) and depressive symptoms', 'TUG scores', 'bone metabolism and functional mobility', 'functional mobility, HRQoL and depressive symptoms', 'lumbar spine and femoral neck', 'I collagen levels', 'serum osteocalcin (OC) and C-terminal telopeptide of type', 'Quality of Life Questionnaire of the European Foundation for Osteoporosis and Beck Depression Inventory', 'BMD at the femoral neck', 'HRQoL and depressive symptoms', 'Bone mineral density (BMD) of the lumbar spine and femur', 'bone loss', 'functional mobility', 'serum OC', 'Timed Up and Go (TUG) test, and fall index']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C0444584', 'cui_str': 'Whole body (qualifier value)'}, {'cui': 'C0459800', 'cui_str': 'Vibration'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0025520', 'cui_str': 'metabolism'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C3887615', 'cui_str': 'Lumbar spine structure (body structure)'}, {'cui': 'C0015815', 'cui_str': 'Femoral Neck'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0373691', 'cui_str': 'Osteocalcin measurement (procedure)'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0239307', 'cui_str': 'European (ethnic group)'}, {'cui': 'C0016617', 'cui_str': 'Foundations'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory (assessment scale)'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0015811', 'cui_str': 'Femur'}, {'cui': 'C0029453', 'cui_str': 'Osteopenia'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0000921', 'cui_str': 'Falls'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",58.0,0.0203392,The serum OC decreased significantly in the WBV group and increased significantly in both the high-impact exercise and control groups (p < 0.001).,"[{'ForeName': 'Ekin Ilke', 'Initials': 'EI', 'LastName': 'Sen', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Istanbul Faculty of Medicine, Istanbul University, Millet Cad, 34093, Istanbul, Turkey. ekinozgorgu@gmail.com.'}, {'ForeName': 'Sina', 'Initials': 'S', 'LastName': 'Esmaeilzadeh', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Istanbul Faculty of Medicine, Istanbul University, Millet Cad, 34093, Istanbul, Turkey.'}, {'ForeName': 'Nurten', 'Initials': 'N', 'LastName': 'Eskiyurt', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Istanbul Faculty of Medicine, Istanbul University, Millet Cad, 34093, Istanbul, Turkey.'}]",Journal of bone and mineral metabolism,['10.1007/s00774-019-01072-2'] 157,31912320,Comparison of radial extracorporeal shockwave therapy with ultrasound therapy in patients with lateral epicondylitis.,"PURPOSE Patients suffering from lateral epicondylitis exhibit diminished mobility due to pain. The aim of the study was to compare the efficacy of both shockwave and ultrasound therapies in patients with lateral epicondylitis. METHODS The shockwave group consisted of 117 patients, 63 patients constituted the ultrasound group, and 18 patients made up the control group. The ""University of Peloponnese Pain, Functionality and Quality of Life Questionnaire"" was used for the evaluation of pain, functionality, and quality of life on a five-point Likert scale, pre-treatment, post-treatment, and at 4-week follow-up. RESULTS The pain was reduced and the functionality and quality of life were improved in both the shockwave and ultrasound groups post-treatment (p < 0.001) and at 4-week follow-up (p < 0.001), but the results in the ultrasound group were not as pronounced as in the shockwave group (p < 0.001). CONCLUSION Both radial shockwave and ultrasound therapies were significantly effective in patients with lateral epicondylitis. However, ultrasound therapy was less effective than shockwave therapy.",2020,"The pain was reduced and the functionality and quality of life were improved in both the shockwave and ultrasound groups post-treatment (p < 0.001) and at 4-week follow-up (p < 0.001), but the results in the ultrasound group were not as pronounced as in the shockwave group (p < 0.001). ","['patients with lateral epicondylitis', '117 patients, 63 patients constituted the ultrasound group, and 18 patients made up the control group', 'Patients suffering from lateral epicondylitis exhibit diminished mobility due to pain']","['radial shockwave and ultrasound therapies', 'shockwave therapy', 'shockwave and ultrasound therapies', 'radial extracorporeal shockwave therapy with ultrasound therapy', 'ultrasound therapy']","['pain', 'pain, functionality, and quality of life', 'functionality and quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0039516', 'cui_str': 'Lateral Epicondylitis'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0015272', 'cui_str': 'Exhibits'}, {'cui': 'C0205216', 'cui_str': 'Decreased (qualifier value)'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]","[{'cui': 'C0442038', 'cui_str': 'Radial (qualifier value)'}, {'cui': 'C0041620', 'cui_str': 'Ultrasonic Therapy'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1737238', 'cui_str': 'Extracorporeal Shockwave Therapy'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0034380'}]",117.0,0.0265122,"The pain was reduced and the functionality and quality of life were improved in both the shockwave and ultrasound groups post-treatment (p < 0.001) and at 4-week follow-up (p < 0.001), but the results in the ultrasound group were not as pronounced as in the shockwave group (p < 0.001). ","[{'ForeName': 'Vasileios', 'Initials': 'V', 'LastName': 'Dedes', 'Affiliation': 'Laboratory of Physiology-Pharmacology, Department of Nursing, Faculty of Human Movement and Quality of Life Sciences, University of Peloponnese, Efstathiou and Stamatikis Valioti and Plateon, 23 100, Sparta, Greece.'}, {'ForeName': 'Konstantinos', 'Initials': 'K', 'LastName': 'Tzirogiannis', 'Affiliation': 'Laboratory of Physiology-Pharmacology, Department of Nursing, Faculty of Human Movement and Quality of Life Sciences, University of Peloponnese, Efstathiou and Stamatikis Valioti and Plateon, 23 100, Sparta, Greece.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Polikandrioti', 'Affiliation': 'Department of Nursing, Faculty of Health and Caring Professions, University of West Attica, Athens, Greece.'}, {'ForeName': 'Ariadni Maria', 'Initials': 'AM', 'LastName': 'Dede', 'Affiliation': 'Engineering in Biotechnology Department, Absalon University College, Kalundborg, Sjelland, Denmark.'}, {'ForeName': 'Athanasios', 'Initials': 'A', 'LastName': 'Mitseas', 'Affiliation': 'Orthopaedic Department, Messinion Therapeutirion, Kalamata, Greece.'}, {'ForeName': 'Georgios I', 'Initials': 'GI', 'LastName': 'Panoutsopoulos', 'Affiliation': 'Laboratory of Physiology-Pharmacology, Department of Nursing, Faculty of Human Movement and Quality of Life Sciences, University of Peloponnese, Efstathiou and Stamatikis Valioti and Plateon, 23 100, Sparta, Greece. gpanouts@uop.gr.'}]",Journal of medical ultrasonics (2001),['10.1007/s10396-019-01002-9'] 158,32331356,Connectivity of Real-Time Video Counselling Versus Telephone Counselling for Smoking Cessation in Rural and Remote Areas: An Exploratory Study.,"This study compared the connectivity of video sessions to telephone sessions delivered to smokers in rural areas and whether remoteness and video app (video only) were associated with the connectivity of video or telephone sessions. Participants were recruited into a randomised trial where two arms offered smoking cessation counselling via: (a) real-time video communication software (201 participants) or (b) telephone (229 participants). Participants were offered up to six video or telephone sessions and the connectivity of each session was recorded. A total of 456 video sessions and 606 telephone sessions were completed. There was adequate connectivity of the video intervention in terms of no echoing noise (97.8%), no loss of internet connection during the session (88.6%), no difficulty hearing the participant (88.4%) and no difficulty seeing the participant (87.5%). In more than 94% of telephone sessions, there was no echoing noise, no difficulty hearing the participant and no loss of telephone line connection. Video sessions had significantly greater odds of experiencing connectivity difficulties than telephone sessions in relation to connecting to the participant at the start (odds ratio, OR = 5.13, 95% confidence interval, CI 1.88-14.00), loss of connection during the session (OR = 11.84, 95% CI 4.80-29.22) and hearing the participant (OR = 2.53, 95% CI 1.41-4.55). There were no significant associations between remoteness and video app and connectivity difficulties in the video or telephone sessions. Real-time video sessions are a feasible option for smoking cessation providers to provide support in rural areas.",2020,"Video sessions had significantly greater odds of experiencing connectivity difficulties than telephone sessions in relation to connecting to the participant at the start (odds ratio, OR = 5.13, 95% confidence interval, CI 1.88-14.00), loss of connection during the session (OR = 11.84, 95% CI 4.80-29.22) and hearing the participant (OR = 2.53, 95% CI 1.41-4.55).","['229 participants', 'Smoking Cessation in Rural and Remote Areas']","['Real-Time Video Counselling Versus Telephone Counselling', 'smoking cessation counselling via: (a) real-time video communication software (201 participants) or (b) telephone']","['loss of connection', 'no loss of internet connection', 'remoteness and video app and connectivity difficulties', 'experiencing connectivity difficulties']","[{'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0037585', 'cui_str': 'Software'}]","[{'cui': 'C0449379', 'cui_str': 'Connection'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}]",,0.0278314,"Video sessions had significantly greater odds of experiencing connectivity difficulties than telephone sessions in relation to connecting to the participant at the start (odds ratio, OR = 5.13, 95% confidence interval, CI 1.88-14.00), loss of connection during the session (OR = 11.84, 95% CI 4.80-29.22) and hearing the participant (OR = 2.53, 95% CI 1.41-4.55).","[{'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Byaruhanga', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, University Drive, Callaghan, New South Wales 2308, Australia.'}, {'ForeName': 'Christine L', 'Initials': 'CL', 'LastName': 'Paul', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, University Drive, Callaghan, New South Wales 2308, Australia.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Wiggers', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, University Drive, Callaghan, New South Wales 2308, Australia.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Byrnes', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, University Drive, Callaghan, New South Wales 2308, Australia.'}, {'ForeName': 'Aimee', 'Initials': 'A', 'LastName': 'Mitchell', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, University Drive, Callaghan, New South Wales 2308, Australia.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Lecathelinais', 'Affiliation': 'Hunter New England Population Health, Hunter New England Local Health District, Locked Mail Bag 10, Wallsend, New South Wales 2287, Australia.'}, {'ForeName': 'Flora', 'Initials': 'F', 'LastName': 'Tzelepis', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, University Drive, Callaghan, New South Wales 2308, Australia.'}]",International journal of environmental research and public health,['10.3390/ijerph17082891'] 159,32331366,"Effects of the Healthy Children, Healthy Families, Healthy Communities Program for Obesity Prevention among Vulnerable Children: A Cluster-Randomized Controlled Trial.","Background : We aimed to examine whether the Healthy Children, Healthy Families, and Healthy Communities Program, consisting of multi-level strategies for obesity prevention tailoring the context of socioeconomically vulnerable children based on an ecological perspective, would be effective on improving their healthy lifestyle behaviors and obesity status. Methods : Participants were 104 children (and 59 parents) enrolled in public welfare systems in Seoul, South Korea. Based on a cluster-randomized controlled trial (no. ISRCTN11347525), eight centers were randomly assigned to intervention (four centers, 49 children, 27 parents) versus control groups (four centers, 55 children, 32 parents). Multi-level interventions of child-, parent-, and center-level strategies were conducted for 12 weeks. Children's healthy lifestyle behaviors and obesity status were assessed as daily recommended levels and body mass index ≥85th percentile, respectively. Parents' parenting behaviors were measured by the Family Nutrition and Physical Activity scale. Results : Compared to the control group, the intervention group showed significant improvements in total composite scores of healthy-lifestyle behaviors-including 60-min of moderate physical activity-but not in obesity status among children. Moreover, the intervention group showed significant improvements in parenting behaviors among parents. Conclusion : The multi-level strategies for obesity prevention based on an ecological perspective may be effective for promoting healthy lifestyles among socioeconomically vulnerable children.",2020,"Compared to the control group, the intervention group showed significant improvements in total composite scores of healthy-lifestyle behaviors-including 60-min of moderate physical activity-but not in obesity status among children.","['Participants were 104 children (and 59 parents) enrolled in public welfare systems in Seoul, South Korea', 'socioeconomically vulnerable children', 'Healthy Children, Healthy Families, and Healthy Communities Program', 'Healthy Children, Healthy Families, Healthy Communities Program for Obesity Prevention among Vulnerable Children']",[],"['total composite scores of healthy-lifestyle behaviors-including 60-min of moderate physical activity', 'Family Nutrition and Physical Activity scale', 'parenting behaviors', ""Children's healthy lifestyle behaviors and obesity status"", ""Parents' parenting behaviors""]","[{'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0037440', 'cui_str': 'Social services'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C3850150', 'cui_str': 'Seoul'}, {'cui': 'C0022773', 'cui_str': 'Republic of Korea'}, {'cui': 'C0425119', 'cui_str': 'Child at risk'}, {'cui': 'C0686744', 'cui_str': 'Well child'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}]",[],"[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C4277664', 'cui_str': 'Healthy Lifestyles'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0686744', 'cui_str': 'Well child'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}]",104.0,0.03545,"Compared to the control group, the intervention group showed significant improvements in total composite scores of healthy-lifestyle behaviors-including 60-min of moderate physical activity-but not in obesity status among children.","[{'ForeName': 'Jina', 'Initials': 'J', 'LastName': 'Choo', 'Affiliation': 'Department of Community Health Nursing, College of Nursing, Korea University, Seoul 02841, Korea.'}, {'ForeName': 'Hwa-Mi', 'Initials': 'HM', 'LastName': 'Yang', 'Affiliation': 'Department of Community Health Nursing, College of Nursing, Korea University, Seoul 02841, Korea.'}, {'ForeName': 'Sae-Young', 'Initials': 'SY', 'LastName': 'Jae', 'Affiliation': 'Department of Sport Science, University of Seoul, Seoul 02504, Korea.'}, {'ForeName': 'Hye-Jin', 'Initials': 'HJ', 'LastName': 'Kim', 'Affiliation': 'Department of Community Health Nursing, College of Nursing, Korea University, Seoul 02841, Korea.'}, {'ForeName': 'Jihyun', 'Initials': 'J', 'LastName': 'You', 'Affiliation': 'Department of Community Health Nursing, College of Nursing, Korea University, Seoul 02841, Korea.'}, {'ForeName': 'Juneyoung', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'Department of Biostatistics, College of Medicine, Korea University, Seoul 02841, Korea.'}]",International journal of environmental research and public health,['10.3390/ijerph17082895'] 160,32087357,The World-wide Randomized Antibiotic Envelope Infection Prevention (WRAP-IT) trial: Long-term follow-up.,"BACKGROUND The World-wide Randomized Antibiotic Envelope Infection Prevention trial reported a 40% reduction in major cardiac implantable electronic device (CIED) infections within 12 months of the procedure with the use of an antibacterial-eluting envelope (TYRX Absorbable Antibacterial Envelope, Medtronic, Mounds View, MN). OBJECTIVE The purpose of this report was to describe the longer-term (>12 months) envelope effects on infection reduction and complications. METHODS All trial patients who underwent CIED replacement, upgrade, revision, or initial cardiac resynchronization therapy - defibrillator implantation received standard-of-care infection prophylaxis and were randomized in a 1:1 ratio to receive the envelope or not. CIED infection incidence and procedure and system-related complications were characterized through all follow-up (36 months) by using Cox proportional hazards regression modeling. RESULTS In total, 6800 patients received their intended randomized treatment (3371 envelope; 3429 control; mean follow-up period 21.0 ± 8.3 months). Major CIED-related infections occurred in 32 envelope patients and 51 control patients (Kaplan-Meier [KM] estimate 1.3% vs 1.9%; hazard ratio [HR] 0.64; 95% confidence interval [CI] 0.41-0.99; P = .046). Any CIED-related infection occurred in 57 envelope patients and 84 control patients (KM estimate 2.1% vs 2.8%; HR 0.69; 95% CI 0.49-0.97; P = .030). System- or procedure-related complications occurred in 235 envelope patients and 252 control patients (KM estimate 8.0% vs 8.2%; HR 0.95; 95% CI 0.79-1.13; P < .001 for noninferiority); the most common were lead dislodgment (1.1%), device lead damage (0.5%), and implant site hematoma (0.4%). Implant site pain occurred less frequently in the envelope group (0.1% vs 0.4%; P = .067). There were no (0.0%) reports of allergic reactions to the components of the envelope (mesh, polymer, or antibiotics). CONCLUSION The effects of the TYRX envelope on the reduction of the risk of CIED infection are sustained beyond the first year postprocedure, without an increased risk of complications.",2020,"Implant site pain occurred less frequently in the envelope group (0.1% vs. 0.4%, P=0.067).","['All trial patients that underwent', '6800 patients received their intended randomized treatment (3371 envelope; 3429 control; mean follow-up 21.0±8.3 months']","['CIED replacement, upgrade, revision, or initial CRT-D implant received standard-of-care infection prophylaxis', 'TYRX', 'Antibiotic Envelope Infection Prevention (WRAP-IT']","['allergic reactions', 'implant site hematoma', 'CIED-related infection', 'Major CIED-related infection', 'Implant site pain', 'risk of CIED infection', 'System- or procedure-related complications', 'lead dislodgement', 'device lead damage', 'CIED infection incidence, and procedure and system-related complications', 'infection reduction and complications']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0439617', 'cui_str': 'Revision - value'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C2828363', 'cui_str': 'Implant'}, {'cui': 'C2936643', 'cui_str': 'Standard of Care'}, {'cui': 'C0877629', 'cui_str': 'Infection prophylaxis'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0445414', 'cui_str': 'Wrapping (procedure)'}]","[{'cui': 'C1527304', 'cui_str': 'Allergic Reaction'}, {'cui': 'C1504450', 'cui_str': 'Implant site haematoma'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C1504452', 'cui_str': 'Implant site pain'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C1868842', 'cui_str': 'Lead dislodgement'}, {'cui': 'C1735592', 'cui_str': 'Device lead damage'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}]",6800.0,0.16719,"Implant site pain occurred less frequently in the envelope group (0.1% vs. 0.4%, P=0.067).","[{'ForeName': 'Suneet', 'Initials': 'S', 'LastName': 'Mittal', 'Affiliation': 'Department of Cardiology, Valley Health System, Ridgewood New Jersey. Electronic address: MITTSU@Valleyhealth.com.'}, {'ForeName': 'Bruce L', 'Initials': 'BL', 'LastName': 'Wilkoff', 'Affiliation': 'Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland Ohio.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Kennergren', 'Affiliation': 'Sahlgrenska Medical Faculty, University of Göteborg, Göteborg, Sweden.'}, {'ForeName': 'Jeanne E', 'Initials': 'JE', 'LastName': 'Poole', 'Affiliation': 'Division of Cardiology, University of Washington School of Medicine, Seattle, Washington.'}, {'ForeName': 'Ralph', 'Initials': 'R', 'LastName': 'Corey', 'Affiliation': 'Department of Medicine, Duke Clinical Research Institute, Durham, North Carolina.'}, {'ForeName': 'Frank A', 'Initials': 'FA', 'LastName': 'Bracke', 'Affiliation': 'Department of Cardiology, Catharina Hospital, Eindhoven, Netherlands.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Curnis', 'Affiliation': 'Department of Clinical and Experimental Sciences, University of Brescia, Brescia, Italy.'}, {'ForeName': 'Kamel', 'Initials': 'K', 'LastName': 'Addo', 'Affiliation': 'Cardiology Division, Mount Carmel Health System, Columbus, Ohio.'}, {'ForeName': 'Joaquin', 'Initials': 'J', 'LastName': 'Martinez-Arraras', 'Affiliation': 'Department of Cardiology, Amarillo Heart Clinical Research Institute, Amarillo, Texas.'}, {'ForeName': 'Ziad F', 'Initials': 'ZF', 'LastName': 'Issa', 'Affiliation': 'Department of Cardiology, Prairie Education & Research Cooperative, Springfield, Illinois.'}, {'ForeName': 'Calum', 'Initials': 'C', 'LastName': 'Redpath', 'Affiliation': 'Division of Cardiology, University of Ottawa Heart Institute, Ottawa, Ontario, Canada.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Moubarak', 'Affiliation': 'Division of Cardiology, UPMC, Hamot Medical Center, Erie, Pennsylvania.'}, {'ForeName': 'Surinder Kaur', 'Initials': 'SK', 'LastName': 'Khelae', 'Affiliation': 'Department of Electrophysiology, Institute Jantung Negara, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Lucas V A', 'Initials': 'LVA', 'LastName': 'Boersma', 'Affiliation': 'Department of Cardiology, St. Antonius Hospital, Nieuwegein, Netherlands; Amsterdam University Medical Centers, Amsterdam, The Netherlands.'}, {'ForeName': 'Panagiotis', 'Initials': 'P', 'LastName': 'Korantzopoulos', 'Affiliation': 'First Department of Cardiology, University of Ioannina Medical School, Ioannina, Greece.'}, {'ForeName': 'Jo', 'Initials': 'J', 'LastName': 'Krueger', 'Affiliation': 'Cardiac Rhythm and Heart Failure (CRHF) Clinical, Medtronic, Mounds View, Minnesota.'}, {'ForeName': 'Jeff D', 'Initials': 'JD', 'LastName': 'Lande', 'Affiliation': 'Cardiac Rhythm and Heart Failure (CRHF) Clinical, Medtronic, Mounds View, Minnesota.'}, {'ForeName': 'Gina M', 'Initials': 'GM', 'LastName': 'Morss', 'Affiliation': 'Cardiac Rhythm and Heart Failure (CRHF) Clinical, Medtronic, Mounds View, Minnesota.'}, {'ForeName': 'Swathi', 'Initials': 'S', 'LastName': 'Seshadri', 'Affiliation': 'Cardiac Rhythm and Heart Failure (CRHF) Clinical, Medtronic, Mounds View, Minnesota.'}, {'ForeName': 'Khaldoun G', 'Initials': 'KG', 'LastName': 'Tarakji', 'Affiliation': 'Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland Ohio.'}]",Heart rhythm,['10.1016/j.hrthm.2020.02.011'] 161,32163837,Graph theoretical measures of the uncinate fasciculus subnetwork as predictors and correlates of treatment response in a transdiagnostic psychiatric cohort.,"The internalizing psychopathologies (IP) are a highly prevalent group of disorders for which little data exists to guide treatment selection. We examine whether graph theoretical metrics from white matter connectomes may serve as biomarkers of disease and predictors of treatment response. We focus on the uncinate fasciculus subnetwork, which has been previously implicated in these disorders. We compared baseline graph measures from a transdiagnostic IP cohort with controls. Patients were randomized to either SSRI or cognitive behavioral therapy and we determined if graph theory metrics change following treatment, and whether these changes correlated with treatment response. Lastly, we investigated whether baseline metrics correlated with treatment response. Several baseline nodal graph metrics differed at baseline. Of note, right amygdala betweenness centrality was increased in patients relative to controls. In addition, white matter integrity of the uncinate fasciculus was decreased at baseline in patients versus controls. The SSRI and CBT cohorts had increased left frontal superior orbital betweenness centrality and left frontal medial orbital clustering coefficient, respectively, suggesting the presence of treatment specific neural correlates of treatment response. This study provides insight on shared white matter network features of IPs and elucidates potential biomarkers of treatment response that may be modality-specific.",2020,"The SSRI and CBT cohorts had increased left frontal superior orbital betweenness centrality and left frontal medial orbital clustering coefficient, respectively, suggesting the presence of treatment specific neural correlates of treatment response.",[],['SSRI or cognitive behavioral therapy'],['white matter integrity of the uncinate fasciculus'],[],"[{'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}]","[{'cui': 'C0682708'}, {'cui': 'C0205266', 'cui_str': 'Intact (qualifier value)'}, {'cui': 'C0228271', 'cui_str': 'Structure of uncinate fasciculus'}]",,0.0831979,"The SSRI and CBT cohorts had increased left frontal superior orbital betweenness centrality and left frontal medial orbital clustering coefficient, respectively, suggesting the presence of treatment specific neural correlates of treatment response.","[{'ForeName': 'Paul J', 'Initials': 'PJ', 'LastName': 'Thomas', 'Affiliation': 'Department of Psychiatry, University of Illinois at Chicago, Chicago, IL, USA; Department of Bioengineering, University of Illinois at Chicago, Chicago, IL, USA.'}, {'ForeName': 'Srinivas', 'Initials': 'S', 'LastName': 'Panchamukhi', 'Affiliation': 'Department of Psychiatry, University of Illinois at Chicago, Chicago, IL, USA.'}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Nathan', 'Affiliation': 'Lake County Health Department, Waukeegan, IL, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Francis', 'Affiliation': 'Department of Behavioral Sciences, Rush University, Chicago, IL, USA.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Langenecker', 'Affiliation': 'Department of Psychiatry, University of Utah, UT, USA.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Gorka', 'Affiliation': 'Department of Psychiatry, University of Illinois at Chicago, Chicago, IL, USA.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Leow', 'Affiliation': 'Department of Psychiatry, University of Illinois at Chicago, Chicago, IL, USA; Department of Bioengineering, University of Illinois at Chicago, Chicago, IL, USA.'}, {'ForeName': 'Heide', 'Initials': 'H', 'LastName': 'Klumpp', 'Affiliation': 'Department of Psychiatry, University of Illinois at Chicago, Chicago, IL, USA.'}, {'ForeName': 'K Luan', 'Initials': 'KL', 'LastName': 'Phan', 'Affiliation': 'Department of Psychiatry, University of Illinois at Chicago, Chicago, IL, USA.'}, {'ForeName': 'Olusola A', 'Initials': 'OA', 'LastName': 'Ajilore', 'Affiliation': 'Department of Psychiatry, University of Illinois at Chicago, Chicago, IL, USA. Electronic address: oajilore@uic.edu.'}]",Psychiatry research. Neuroimaging,['10.1016/j.pscychresns.2020.111064'] 162,32322697,Resveratrol plus carboxymethyl-β-glucan in infants with common cold: a randomized double-blind trial.,"Objectives To evaluate effectiveness of a nasal resveratrol/carboxymethyl-β-glucan solution compared to nasal saline solution: a) on common cold symptoms by means of a validated measure scale (CARIFS score), b) on Rhinovirus infection and CCL2, CCL5, IL8, IL6, CXCL10 and TLR2 expression in nasal swabs, c) on frequency of relapses after 30 days of follow-up. Methods 89 infants with respiratory infection symptoms were randomly assigned to receive either a nasal resveratrol/carboxymethyl-β-glucan solution or nasal saline solution. All patients were evaluated with CARIFS score at enrollment, after 48 hours, 7 and 30 days by physicians and parents. Nasal swabs were obtained at enrollment, after 48 hours and after one week. Results CARIFS score improved in both groups. Episodes of sneezing and cough were fewer in study group after 7 days of follow-up (p<001). No significant differences were found on nasopharyngeal swabs in Rhinovirus detection and cytokines expression after 48 hours, nor in 30 days relapses. TLR2 expression was significantly higher in Rhinovirus infected children of the study group. No adverse effects occurred. Conclusions These data suggest that a solution containing resveratrol plus carboxymethyl-β-glucan might be have a positive impact on both clinical and socio-economic burden due to infant common cold.",2020,Episodes of sneezing and cough were fewer in study group after 7 days of follow-up (p<001).,"['89 infants with respiratory infection symptoms', 'infants with common cold']","['nasal resveratrol/carboxymethyl-β-glucan solution', 'nasal saline solution', 'nasal resveratrol/carboxymethyl-β-glucan solution or nasal saline solution', 'Resveratrol plus carboxymethyl-β-glucan']","['TLR2 expression', 'Episodes of sneezing and cough', 'measure scale (CARIFS score), b) on Rhinovirus infection and CCL2, CCL5, IL8, IL6, CXCL10 and TLR2 expression in nasal swabs, c) on frequency of relapses', 'nasopharyngeal swabs in Rhinovirus detection and cytokines expression', 'CARIFS score']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0035243', 'cui_str': 'Respiratory tract infection'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0009443', 'cui_str': 'Common cold'}]","[{'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0073096', 'cui_str': 'resveratrol'}, {'cui': 'C0017692', 'cui_str': 'Glucan (BO)'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0754727', 'cui_str': 'TLR2 protein, human'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0037383', 'cui_str': 'Sneezing'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0276447', 'cui_str': 'Disease due to Rhinovirus'}, {'cui': 'C1449159', 'cui_str': 'CCL2 protein, human'}, {'cui': 'C1436337', 'cui_str': 'CCL5 protein, human'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C1308752', 'cui_str': 'CXCL10 protein, human'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0183753', 'cui_str': 'Swab'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0444192', 'cui_str': 'Nasopharyngeal swab'}, {'cui': 'C0035473', 'cui_str': 'Rhinovirus'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}]",89.0,0.492629,Episodes of sneezing and cough were fewer in study group after 7 days of follow-up (p<001).,"[{'ForeName': 'Maria Elisabetta', 'Initials': 'ME', 'LastName': 'Baldassarre', 'Affiliation': 'Department of Biomedical Science and Human Oncology, Neonatology and Neonatal Intensive Care Unit, ""Aldo Moro"" University of Bari, Bari 70100, Italy.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Di Mauro', 'Affiliation': 'Department of Biomedical Science and Human Oncology, Neonatology and Neonatal Intensive Care Unit, ""Aldo Moro"" University of Bari, Bari 70100, Italy.'}, {'ForeName': 'Grazia', 'Initials': 'G', 'LastName': 'Labellarte', 'Affiliation': 'Department of Biomedical Science and Human Oncology, Neonatology and Neonatal Intensive Care Unit, ""Aldo Moro"" University of Bari, Bari 70100, Italy.'}, {'ForeName': 'Mariacristina', 'Initials': 'M', 'LastName': 'Pignatelli', 'Affiliation': 'Department of Biomedical Science and Human Oncology, Neonatology and Neonatal Intensive Care Unit, ""Aldo Moro"" University of Bari, Bari 70100, Italy.'}, {'ForeName': 'Margherita', 'Initials': 'M', 'LastName': 'Fanelli', 'Affiliation': 'Department of Interdisciplinary Medicine, ""Aldo Moro"" University of Bari, Bari 70100, Italy.'}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Schiavi', 'Affiliation': 'Department of Public Health and Infectious Disease, ""Sapienza"" University of Rome, Rome 00100, Italy.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Mastromarino', 'Affiliation': 'Department of Public Health and Infectious Disease, ""Sapienza"" University of Rome, Rome 00100, Italy.'}, {'ForeName': 'Manuela', 'Initials': 'M', 'LastName': 'Capozza', 'Affiliation': 'Department of Biomedical Science and Human Oncology, Neonatology and Neonatal Intensive Care Unit, ""Aldo Moro"" University of Bari, Bari 70100, Italy.'}, {'ForeName': 'Raffaella', 'Initials': 'R', 'LastName': 'Panza', 'Affiliation': 'Department of Biomedical Science and Human Oncology, Neonatology and Neonatal Intensive Care Unit, ""Aldo Moro"" University of Bari, Bari 70100, Italy.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Laforgia', 'Affiliation': 'Department of Biomedical Science and Human Oncology, Neonatology and Neonatal Intensive Care Unit, ""Aldo Moro"" University of Bari, Bari 70100, Italy.'}]",Heliyon,['10.1016/j.heliyon.2020.e03814'] 163,32131611,Activated Platelets Induce Endothelial Cell Inflammatory Response in Psoriasis via COX-1.,"OBJECTIVE Patients with psoriasis have impaired vascular health and increased cardiovascular disease (CVD). Platelets are key players in the pathogenesis of vascular dysfunction in cardiovascular disease and represent therapeutic targets in cardiovascular prevention. The object of this study was to define the platelet phenotype and effector cell properties on vascular health in psoriasis and evaluate whether aspirin modulates the platelet-induced phenotype. Approach and Results: Platelets from psoriasis patients (n=45) exhibited increased platelet activation (relative to age- and gender-matched controls, n=18), which correlated with psoriasis skin severity. Isolated platelets from psoriasis patients demonstrated a 2- to 3-fold ( P <0.01) increased adhesion to human aortic endothelial cells and induced proinflammatory transcriptional changes, including upregulation of IL 8 (interleukin 8), IL1β , and Cox (cyclooxygenase)-2 Platelet RNA sequencing revealed an interferon signature and elevated expression of COX-1 , which correlated with psoriasis disease severity ( r =0.83, P =0.01). In a randomized trial of patients with psoriasis, 2 weeks of 81 mg low-dose aspirin, a COX-1 inhibitor, reduced serum thromboxane (Tx) B 2 and reduced brachial vein endothelial proinflammatory transcript expression >70% compared with the no-treatment group ( P <0.01). Improvement in brachial vein endothelial cell inflammation significantly correlated with change in serum TxB 2 ( r =0.48, P =0.02). CONCLUSIONS In patients with psoriasis, platelets are activated and induce endothelial cell inflammation. Low-dose aspirin improved endothelial cell health in psoriasis via platelet COX-1 inhibition. These data demonstrate a previously unappreciated role of platelets in psoriasis and endothelial cell inflammation and suggests that aspirin may be effective in improving vascular health in patients with psoriasis. Registration: URL: http://www.clinicaltrials.gov. Unique identifier: NCT03228017.",2020,(Tx) B 2 and reduced brachial vein endothelial proinflammatory transcript expression >70% compared with the no-treatment group ( P <0.01).,"['psoriasis patients (n=45', 'Patients with psoriasis have impaired vascular health and increased cardiovascular disease (CVD', 'Psoriasis Via COX-1 (Cyclooxygenase-2', 'patients with psoriasis']","['aspirin', 'Low-dose aspirin', 'aspirin, a COX-1 inhibitor, reduced serum thromboxane']","['adhesion to human aortic endothelial cells and induced proinflammatory transcriptional changes, including upregulation of IL 8 (interleukin 8), IL1β , and COX-2 (cyclooxygenase-2', 'endothelial cell health', 'vascular health', 'psoriasis skin severity', 'Tx) B 2 and reduced brachial vein endothelial proinflammatory transcript expression', 'platelet activation', 'psoriasis disease severity', 'interferon signature and elevated expression of COX-1', 'brachial vein endothelial cell inflammation']","[{'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0221099', 'cui_str': 'Impaired (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}, {'cui': 'C0442996', 'cui_str': 'Cox (qualifier value)'}, {'cui': 'C0387583', 'cui_str': 'COX-2 Prostaglandin Synthase'}]","[{'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0442996', 'cui_str': 'Cox (qualifier value)'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0040061', 'cui_str': 'Thromboxanes'}]","[{'cui': 'C0001511', 'cui_str': 'Tissue Adhesions'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0003483', 'cui_str': 'Aorta'}, {'cui': 'C0225336', 'cui_str': 'Endothelial Cells'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0041904', 'cui_str': 'Up-Regulation (Physiology)'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C0021764', 'cui_str': 'Interleukins'}, {'cui': 'C0442996', 'cui_str': 'Cox (qualifier value)'}, {'cui': 'C0387583', 'cui_str': 'COX-2 Prostaglandin Synthase'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0045550', 'cui_str': 'sodium 2,5-dichloro-4-bromophenol'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0226812', 'cui_str': 'Structure of brachial vein'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0032173', 'cui_str': 'Platelet Activation'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0021747', 'cui_str': 'Interferons'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}]",,0.0576413,(Tx) B 2 and reduced brachial vein endothelial proinflammatory transcript expression >70% compared with the no-treatment group ( P <0.01).,"[{'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Garshick', 'Affiliation': 'From the Department of Medicine, Center for the Prevention of Cardiovascular Disease (M.S.G., E.A.F., J.S.B.), New York University School of Medicine.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Tawil', 'Affiliation': 'Leon H. Charney Division of Cardiology, Department of Medicine (M.S.G., M.T., T.J.B., M.E., A.L., E.A.F., J.S.B.), New York University School of Medicine.'}, {'ForeName': 'Tessa J', 'Initials': 'TJ', 'LastName': 'Barrett', 'Affiliation': 'Leon H. Charney Division of Cardiology, Department of Medicine (M.S.G., M.T., T.J.B., M.E., A.L., E.A.F., J.S.B.), New York University School of Medicine.'}, {'ForeName': 'Charissa M', 'Initials': 'CM', 'LastName': 'Salud-Gnilo', 'Affiliation': 'Laboratory for Investigative Dermatology, Rockefeller University, New York (C.M.S.-G, J.G.K.).'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Eppler', 'Affiliation': 'Leon H. Charney Division of Cardiology, Department of Medicine (M.S.G., M.T., T.J.B., M.E., A.L., E.A.F., J.S.B.), New York University School of Medicine.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Lee', 'Affiliation': 'Leon H. Charney Division of Cardiology, Department of Medicine (M.S.G., M.T., T.J.B., M.E., A.L., E.A.F., J.S.B.), New York University School of Medicine.'}, {'ForeName': 'Jose U', 'Initials': 'JU', 'LastName': 'Scher', 'Affiliation': 'Division of Rheumatology, Department of Medicine, Psoriatic Arthritis Center (J.U.S.), New York University School of Medicine.'}, {'ForeName': 'Andrea L', 'Initials': 'AL', 'LastName': 'Neimann', 'Affiliation': 'Ronald O. Perelman Department of Dermatology (A.L.N.), New York University School of Medicine.'}, {'ForeName': 'Sanja', 'Initials': 'S', 'LastName': 'Jelic', 'Affiliation': 'Division of Pulmonary, Allergy & Critical Care Medicine, Department of Medicine, Columbia University Medical Center, New York (S.J.).'}, {'ForeName': 'Nehal N', 'Initials': 'NN', 'LastName': 'Mehta', 'Affiliation': 'Section of Inflammation and Cardiometabolic Diseases, National Heart, Lung and Blood Institute, National Institutes of Health, Bethesda, MD (N.N.M.).'}, {'ForeName': 'Edward A', 'Initials': 'EA', 'LastName': 'Fisher', 'Affiliation': 'From the Department of Medicine, Center for the Prevention of Cardiovascular Disease (M.S.G., E.A.F., J.S.B.), New York University School of Medicine.'}, {'ForeName': 'James G', 'Initials': 'JG', 'LastName': 'Krueger', 'Affiliation': 'Laboratory for Investigative Dermatology, Rockefeller University, New York (C.M.S.-G, J.G.K.).'}, {'ForeName': 'Jeffrey S', 'Initials': 'JS', 'LastName': 'Berger', 'Affiliation': 'From the Department of Medicine, Center for the Prevention of Cardiovascular Disease (M.S.G., E.A.F., J.S.B.), New York University School of Medicine.'}]","Arteriosclerosis, thrombosis, and vascular biology",['10.1161/ATVBAHA.119.314008'] 164,32278103,The effect of increased abdominal pressure on internal jugular vein catheterization under ultrasound-guidance on conscious patients: A randomised controlled trial.,"BACKGROUND The shape and cross-sectional area (CSA) of internal jugular vein (IJV) are easily affected by external factors. That causes venous collapsibility. We tried to distend IJV by increasing the pressure on patients' abdomen in order to improve the success rate of internal jugular vein catheterization (IJVC). MATERIALS AND METHODS Patients undergoing IJVC were randomly allocated to two groups: Group 1 and Group 2. For patients in Group 1, the pressure on abdomen was increased by placing a 3000 ml bag of normal saline (NS). No special treatment was arranged for patients in Group 2. Transverse images of right IJV were captured at the outer edge which was parallel to the cricoid by ultrasonography. CSA, circumference (CF), transverse diameter (TD) and anteroposterior diameter (APD) of right IJV were measured and compared. All patients underwent ultrasound-guided short-axis puncturing. The success rates of one-off puncturing in two groups were recorded and compared. RESULTS The results under ultrasonography assessments show that CF, CSA, APD and success rate of puncturing in Group 1 were significantly higher than that of Group 2 (P < 0.05), while TD was not significantly increased (P > 0.05). There was no significant difference in complications between two groups (P > 0.05). CONCLUSION Pressure on the abdomen could significantly increase CSA of IJV. That helps improving the success rate of one-off puncturing.",2020,"There was no significant difference in complications between two groups (P>0.05). ","['Patients undergoing IJVC', 'conscious patients']","['ultrasound-guided short-axis puncturing', 'internal jugular vein catheterization under ultrasound-guidance']","['CSA of IJV', 'Transverse images of right IJV', 'success rates of one-off puncturing', 'success rate', 'success rate of internal jugular vein catheterization (IJVC', 'CSA, circumference (CF), transverse diameter (TD) and anteroposterior diameter (APD) of right IJV', 'CF, CSA, APD and success rate of puncturing', 'pressure on abdomen', 'complications']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0226550', 'cui_str': 'Internal jugular vein structure'}, {'cui': 'C0007430', 'cui_str': 'Catheterization'}, {'cui': 'C0234421', 'cui_str': 'Consciousness'}]","[{'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0522488', 'cui_str': 'Short axis'}, {'cui': 'C0226550', 'cui_str': 'Internal jugular vein structure'}, {'cui': 'C0007430', 'cui_str': 'Catheterization'}, {'cui': 'C0442973', 'cui_str': 'Ultrasonic guidance procedure'}]","[{'cui': 'C0010362', 'cui_str': 'Cross Sectional Analysis'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0226550', 'cui_str': 'Internal jugular vein structure'}, {'cui': 'C0205106', 'cui_str': 'Transverse plane'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0033119', 'cui_str': 'Puncture'}, {'cui': 'C0007430', 'cui_str': 'Catheterization'}, {'cui': 'C0332520', 'cui_str': 'Circumference'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",,0.0313309,"There was no significant difference in complications between two groups (P>0.05). ","[{'ForeName': 'Jing-Li', 'Initials': 'JL', 'LastName': 'Yang', 'Affiliation': 'Department of Anesthesiology, Shanghai Pudong Hospital, Fudan University Pudong Medical Center, 2800 Gongwei Road, Huinan Town, Pudong, Shanghai, 201399, China.'}, {'ForeName': 'Peng-Cheng', 'Initials': 'PC', 'LastName': 'Xie', 'Affiliation': 'Department of Anesthesiology, Shanghai Pudong Hospital, Fudan University Pudong Medical Center, 2800 Gongwei Road, Huinan Town, Pudong, Shanghai, 201399, China. Electronic address: xpch-xz@163.com.'}, {'ForeName': 'Guo-Ping', 'Initials': 'GP', 'LastName': 'Ma', 'Affiliation': 'Department of Anesthesiology, Shanghai University of Medicine & Health Sciences Affiliated Zhoupu Hospital, No.1500 Zhouyuan Road, Pudong, Shanghai, 201318, China. Electronic address: gpmshiyan@126.com.'}, {'ForeName': 'Zhan-Fang', 'Initials': 'ZF', 'LastName': 'Li', 'Affiliation': 'Department of Anesthesiology, Shanghai Pudong Hospital, Fudan University Pudong Medical Center, 2800 Gongwei Road, Huinan Town, Pudong, Shanghai, 201399, China.'}]","International journal of surgery (London, England)",['10.1016/j.ijsu.2020.03.069'] 165,31217579,Management of primary pterygium with intra-lesional injection of 5 flurouracil and bevacizumab (Avastin).,"BACKGROUND To assess the efficacy of combined 5FU and Avastin injections in the treatment of primary pterygium METHODS: Sixteen eyes with primary pterygium received intralesional 5 fluorouracil and Avastin (2.5-5 mg) injections every 2 weeks for a maximum of five injections. Fourteen eyes of 14 patients received five injections, one eye received three injections and one eye received two injections. All eyes were followed at monthly intervals for 3 months after last injection. Tissue was obtained by surgical excision of primary pterygium from four eyes who received injections and three eyes with primary pterygium who did not receive injections (control) and subjected to immunohistological examination for beta fibroblast growth factor (bFGF), vascular endothelial growth factor (VEGF), epidermal growth factor (EGF), von-Willebrand factor (vWF), lymphatic vessel endothelial hyaluronan receptor (LYVE-1) and collagen-I. RESULTS Pterygium progression was arrested in all patients. Sixty-two percent of patients had improvement of redness while 89% had reduced thickness of the lesion. VEGF, bFGF, EGF, vWF, LYVE-1 and collagen-I were all reduced in the injected samples. CONCLUSIONS The injection of 5 fluorouracil and Avastin act synergistically to arrest progression and induce atrophy in primary pterygium. This is related to the effect of agents on fibroblasts, collagen, and vascular tissues. Such medical intervention is a safe and viable option in the management of primary pterygium though excision of residual tissue is still required in some cases. Longer follow up is needed to ascertain whether this will reduce the recurrence rate following excision.",2019,"VEGF, bFGF, EGF, vWF, LYVE-1 and collagen-I were all reduced in the injected samples. ","['primary pterygium', 'Fourteen eyes of 14 patients', 'primary pterygium with intra-lesional injection of 5', 'Sixteen eyes with primary pterygium']","['combined 5FU and Avastin injections', 'intralesional 5 fluorouracil and Avastin', 'primary pterygium who did not receive injections (control) and subjected to immunohistological examination for beta fibroblast growth factor (bFGF', 'fluorouracil and Avastin', 'flurouracil and bevacizumab (Avastin']","['Pterygium progression', 'vascular endothelial growth factor (VEGF), epidermal growth factor (EGF), von-Willebrand factor (vWF), lymphatic vessel endothelial hyaluronan receptor (LYVE-1) and collagen-I', 'redness', 'VEGF, bFGF, EGF, vWF, LYVE-1 and collagen-I', 'recurrence rate']","[{'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0033999', 'cui_str': 'Pterygium'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C3715157', 'cui_str': '16'}]","[{'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C1135130', 'cui_str': 'Avastin'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0033999', 'cui_str': 'Pterygium'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C1273867', 'cui_str': 'Examination (heading)'}, {'cui': 'C0330390', 'cui_str': 'Beta (organism)'}, {'cui': 'C0016026', 'cui_str': 'DNA Synthesis Factor'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}]","[{'cui': 'C0033999', 'cui_str': 'Pterygium'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0078058', 'cui_str': 'Vascular Endothelial Growth Factor A'}, {'cui': 'C0242275', 'cui_str': 'Epidermal Growth Factor'}, {'cui': 'C0042971', 'cui_str': 'von Willebrand factor'}, {'cui': 'C0229889', 'cui_str': 'Structure of lymphatic vessel'}, {'cui': 'C0243982', 'cui_str': 'Hyaluronan Receptors'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0332575', 'cui_str': 'Red color (finding)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}]",,0.0193891,"VEGF, bFGF, EGF, vWF, LYVE-1 and collagen-I were all reduced in the injected samples. ","[{'ForeName': 'Noha', 'Initials': 'N', 'LastName': 'Ghoz', 'Affiliation': 'Academic section of ophthalmology, Division of Clinical Neuroscience, University of Nottingham and Department of Ophthalmology, Nottingham University Hospitals, NHS Trust, Nottingham, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Britton', 'Affiliation': 'Academic section of ophthalmology, Division of Clinical Neuroscience, University of Nottingham and Department of Ophthalmology, Nottingham University Hospitals, NHS Trust, Nottingham, UK.'}, {'ForeName': 'Andrew R', 'Initials': 'AR', 'LastName': 'Ross', 'Affiliation': 'Academic section of ophthalmology, Division of Clinical Neuroscience, University of Nottingham and Department of Ophthalmology, Nottingham University Hospitals, NHS Trust, Nottingham, UK.'}, {'ForeName': 'Imran', 'Initials': 'I', 'LastName': 'Mohammed', 'Affiliation': 'Academic section of ophthalmology, Division of Clinical Neuroscience, University of Nottingham and Department of Ophthalmology, Nottingham University Hospitals, NHS Trust, Nottingham, UK.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Hogan', 'Affiliation': 'Academic section of ophthalmology, Division of Clinical Neuroscience, University of Nottingham and Department of Ophthalmology, Nottingham University Hospitals, NHS Trust, Nottingham, UK.'}, {'ForeName': 'Dalia G', 'Initials': 'DG', 'LastName': 'Said', 'Affiliation': 'Academic section of ophthalmology, Division of Clinical Neuroscience, University of Nottingham and Department of Ophthalmology, Nottingham University Hospitals, NHS Trust, Nottingham, UK.'}, {'ForeName': 'Harminder S', 'Initials': 'HS', 'LastName': 'Dua', 'Affiliation': 'Academic section of ophthalmology, Division of Clinical Neuroscience, University of Nottingham and Department of Ophthalmology, Nottingham University Hospitals, NHS Trust, Nottingham, UK. harminder.dua@nottingham.ac.uk.'}]","Eye (London, England)",['10.1038/s41433-019-0493-0'] 166,32307828,"Efficacy of health coaching and a web-based program on physical activity, weight, and distress management among cancer survivors: A multi-centered randomised controlled trial.","OBJECTIVES To investigate the efficacy of health coaching and a web-based program on survivor physical activity (PA), weight, and distress management among stomach, colon, lung and breast cancer patients. METHODS This randomised, controlled, 1-year trial conducted in five hospitals recruited cancer survivors within 2 months of completing primary cancer treatment who had not met ≥1 of these behavioural goals: (i) conducting moderate PA for at least 150 minutes/week or strenuous exercise for over 75 minutes per week or, in the case of lung cancer patients, low or moderate intensity exercise for over 12.5 MET per week, (ii) maintaining normal weight, and (iii) attaining a score >72 in the Post Traumatic Growth Inventory (PTGI). Participants were randomly assigned to one of three groups: the control group, a web-only group, or a health coaching + web group. The primary endpoint was based on a composite of PA, weight, and PTGI score at 12 months. RESULTS Patients in the health coaching + web group (difference = 6.6%, P = .010) and the web-only group (difference = 5.9%, P = .031) had greater overall improvements across the three-outcome composite than the control group. The health coaching + web group had greater overall improvement in PTGI (difference = 12.6%; P < .001) than the control group, but not in PA and weight. CONCLUSION The web-based program, with or without health coaching, may improve health behaviours including PA, weight, and distress management among cancer survivors within 2 months of completing primary cancer treatment. The web-based program with health coaching was mainly effective for reducing psychological distress.",2020,"RESULTS Patients in the health coaching+web group (difference = 6·6%, P=0.010) and the Web-only group (difference = 5·9%, P=0.031) had greater overall improvements across the 3-outcome composite than the control group.","['cancer survivors', '5 hospitals recruited cancer survivors within 2 months of completing primary cancer treatment who had not met ≥1 of these behavioral goals: i) conducting moderate PA for at least 150 min/week or', 'stomach, colon, lung and breast cancer patients', 'cancer survivors within 2 months of completing primary cancer treatment']","['lung cancer patients, low or moderate intensity exercise for over 12·5 MET per week, ii) maintaining normal weight, and iii) attaining a score >72 in the Post Traumatic Growth Inventory (PTGI', 'health coaching and a Web-based program', 'strenuous exercise', 'control group, a Web-only group, or a health coaching + Web group']","['composite of PA, weight, and PTGI score', 'overall improvement in PTGI', 'survivor physical activity (PA), weight, and distress management', 'psychological distress', 'physical activity, weight, and distress management']","[{'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0038351', 'cui_str': 'Stomach'}, {'cui': 'C0009368', 'cui_str': 'Colonic'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C2712185', 'cui_str': 'Normal weight'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0332663', 'cui_str': 'Traumatic'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0815107', 'cui_str': 'Emotional Distress'}]",5.0,0.0411775,"RESULTS Patients in the health coaching+web group (difference = 6·6%, P=0.010) and the Web-only group (difference = 5·9%, P=0.031) had greater overall improvements across the 3-outcome composite than the control group.","[{'ForeName': 'Young Ho', 'Initials': 'YH', 'LastName': 'Yun', 'Affiliation': 'Department of Family Medicine, Seoul National University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Cheol Il', 'Initials': 'CI', 'LastName': 'Lim', 'Affiliation': 'Department of Education, Seoul National University College of Education, Seoul, South Korea.'}, {'ForeName': 'Eun Sook', 'Initials': 'ES', 'LastName': 'Lee', 'Affiliation': 'Research Institute and Hospital, National Cancer Center, Goyang, South Korea.'}, {'ForeName': 'Young Tae', 'Initials': 'YT', 'LastName': 'Kim', 'Affiliation': 'Department of Cardiovascular and Thoracic Surgery, Seoul National University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Kyung Hwan', 'Initials': 'KH', 'LastName': 'Shin', 'Affiliation': 'Department of Radiation Oncology, Seoul National University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Young-Woo', 'Initials': 'YW', 'LastName': 'Kim', 'Affiliation': 'Research Institute and Hospital, National Cancer Center, Goyang, South Korea.'}, {'ForeName': 'Kyu Joo', 'Initials': 'KJ', 'LastName': 'Park', 'Affiliation': 'Department of Surgery, Seoul National University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Seung-Yong', 'Initials': 'SY', 'LastName': 'Jeong', 'Affiliation': 'Department of Surgery, Seoul National University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Keun Won', 'Initials': 'KW', 'LastName': 'Ryu', 'Affiliation': 'Research Institute and Hospital, National Cancer Center, Goyang, South Korea.'}, {'ForeName': 'Wonshik', 'Initials': 'W', 'LastName': 'Han', 'Affiliation': 'Department of Surgery, Seoul National University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Kyung Hae', 'Initials': 'KH', 'LastName': 'Jung', 'Affiliation': 'Department of Oncology, University of Ulsan College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Sung Chan', 'Initials': 'SC', 'LastName': 'Park', 'Affiliation': 'Research Institute and Hospital, National Cancer Center, Goyang, South Korea.'}, {'ForeName': 'Moon Soo', 'Initials': 'MS', 'LastName': 'Kim', 'Affiliation': 'Research Institute and Hospital, National Cancer Center, Goyang, South Korea.'}, {'ForeName': 'Sung', 'Initials': 'S', 'LastName': 'Kim', 'Affiliation': 'Department of Surgery, Sungkyunkwan University School of Medicine, Seoul, South Korea.'}, {'ForeName': 'Young Mog', 'Initials': 'YM', 'LastName': 'Shim', 'Affiliation': 'Department of Cardiovascular and Thoracic Surgery, Sungkyunkwan University School of Medicine, Seoul, South Korea.'}, {'ForeName': 'Jae Hwan', 'Initials': 'JH', 'LastName': 'Oh', 'Affiliation': 'Research Institute and Hospital, National Cancer Center, Goyang, South Korea.'}, {'ForeName': 'Jong Mog', 'Initials': 'JM', 'LastName': 'Lee', 'Affiliation': 'Research Institute and Hospital, National Cancer Center, Goyang, South Korea.'}, {'ForeName': 'Seung-Bum', 'Initials': 'SB', 'LastName': 'Ryoo', 'Affiliation': 'Department of Surgery, Seoul National University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Joohyun', 'Initials': 'J', 'LastName': 'Woo', 'Affiliation': 'Department of Oncology, Ewha Womans University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Dong-Young', 'Initials': 'DY', 'LastName': 'Noh', 'Affiliation': 'Department of Surgery, Seoul National University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Ji Won', 'Initials': 'JW', 'LastName': 'Park', 'Affiliation': 'Department of Surgery, Seoul National University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Byung', 'Initials': 'B', 'LastName': 'In Moon', 'Affiliation': 'Department of Oncology, Ewha Womans University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Hak Jae', 'Initials': 'HJ', 'LastName': 'Kim', 'Affiliation': 'Department of Radiation Oncology, Seoul National University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Seok Jin', 'Initials': 'SJ', 'LastName': 'Nam', 'Affiliation': 'Department of Surgery, Sungkyunkwan University School of Medicine, Seoul, South Korea.'}, {'ForeName': 'Dae Ho', 'Initials': 'DH', 'LastName': 'Lee', 'Affiliation': 'Department of Oncology, University of Ulsan College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Jae Il', 'Initials': 'JI', 'LastName': 'Zo', 'Affiliation': 'Department of Cardiovascular and Thoracic Surgery, Sungkyunkwan University School of Medicine, Seoul, South Korea.'}, {'ForeName': 'Sang Min', 'Initials': 'SM', 'LastName': 'Park', 'Affiliation': 'Department of Family Medicine, Seoul National University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'EunKyo', 'Initials': 'E', 'LastName': 'Kang', 'Affiliation': 'Department of Family Medicine, Seoul National University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'YeEun', 'Initials': 'Y', 'LastName': 'Rhee', 'Affiliation': 'Department of Family Medicine, Seoul National University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Ju Youn', 'Initials': 'JY', 'LastName': 'Jung', 'Affiliation': 'Department of Family Medicine, Seoul National University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Jin Ah', 'Initials': 'JA', 'LastName': 'Sim', 'Affiliation': 'Department of Family Medicine, Seoul National University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Joonki', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'Department of Preventive Medicine, Seoul National University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Aesun', 'Initials': 'A', 'LastName': 'Shin', 'Affiliation': 'Department of Preventive Medicine, Seoul National University College of Medicine, Seoul, South Korea.'}]",Psycho-oncology,['10.1002/pon.5394'] 167,32322811,HIV self-testing among young women in rural South Africa: A randomized controlled trial comparing clinic-based HIV testing to the choice of either clinic testing or HIV self-testing with secondary distribution to peers and partners.,"Background HIV testing rates in many hyper-endemic areas are lower than needed to curtail the HIV epidemic. New HIV testing strategies are needed to overcome barriers to traditional clinic based testing; HIV self-testing is one modality that offers promise in reaching individuals who experience barriers to clinic-based testing. Methods We conducted a randomized control trial among young women ages 18-26 living in rural Mpumalanga, South Africa where they were randomized in a 1:1 allocation to either the: (1) HIV Counseling and Testing (HCT) arm: an invitation to test at one of the 9 local government clinics where free HCT is provided and is standard of care (SOC), or (2) choice arm: choice of either a clinic-based HCT invitation or oral HIV Self-Testing (HIVST) kits. Depending on the arm, participants were also provided either: (1) 4 HCT invitations to provide to peers/partners for HIV testing at one of the 9 local clinics, or (2) 4 HIV self-test kits to provide to peers/partners (thus 5 total HIVST kits or HCT invitations). Young women were asked to return 3 months and 9 months after enrollment to assess testing uptake and invitation or kit distribution to peers and partners and experiences with testing. Peers and partners who were reported by index participants to have received kits/invitations during follow-up visits were also invited to attend a study visit to assess their testing experiences. The trial is registered at clinical trials.gov NCT03162965. Findings 287 young women were enrolled and randomized, with 146 randomized to the HCT arm and 141 to the choice (HCT or HIVST) arm. Of those randomized to the choice arm, over 95% (n=135) chose the HIV self-testing kit and only 6 individuals chose HCT. At the 3-month follow-up visit, 92% of index participants in the choice arm reported having tested for HIV compared to 43% of participants in the HCT arm, resulting in a significant risk difference of 49% (95% CI 40%, 58%). By 9 months, this difference decreased to a risk difference of 25% (95% CI 17%, 33%) between arms (96% in the choice arm and 72% in the HCT arm). Participants in the choice arm were also more likely to invite peers and partners to test compared to the HCT arm (94% vs. 76% or an average of 4.97 vs 2.79 tests). Few male partners were invited to test by index participants; however, index participants in the choice arm were more likely to have their male partners test than index participants in the HCT arm (RR 2.99, 95% CI 1.45, 6.16). Interpretation When given a choice between clinic-based HIV testing and HIV oral self-testing, the overwhelming majority of young women chose HIVST. In addition, those offered a choice of HIV testing modality were much more likely to test, distribute test kits to peers and partners, and to have peers and partners who reported testing compared to the HCT arm. Self-testing offers an important opportunity to significantly increase testing rates among young women and their peers and partners compared to clinic-based HCT. Other strategies to reach men with testing are needed. Funding US National Institutes of Health.",2020,Self-testing offers an important opportunity to significantly increase testing rates among young women and their peers and partners compared to clinic-based HCT.,"['Peers and partners who were reported by index participants to have received kits/invitations during follow-up visits', 'Few male partners', 'Young women', '287 young women', 'young women in rural South Africa', 'young women ages 18-26 living in rural Mpumalanga, South Africa']","['HCT', 'HCT invitations to provide to peers/partners for HIV testing at one of the 9 local clinics, or (2) 4 HIV self-test kits to provide to peers/partners (thus 5 total HIVST kits or HCT invitations', 'clinic-based HCT invitation or oral HIV Self-Testing (HIVST) kits', 'HIV self-testing kit and only 6 individuals chose HCT', 'HIV Counseling and Testing (HCT', 'choice (HCT or HIVST']",['testing rates'],"[{'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0812225', 'cui_str': 'Device kit'}, {'cui': 'C0589121', 'cui_str': 'Follow-up visit'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517682', 'cui_str': '287'}, {'cui': 'C0037712', 'cui_str': 'South Africa'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}]","[{'cui': 'C0730426', 'cui_str': 'Human immunodeficiency virus counseling'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0459958', 'cui_str': 'HIV screening'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1272835', 'cui_str': 'Test kit'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0812225', 'cui_str': 'Device kit'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}]","[{'cui': 'C0392366', 'cui_str': 'Tests'}]",287.0,0.0557704,Self-testing offers an important opportunity to significantly increase testing rates among young women and their peers and partners compared to clinic-based HCT.,"[{'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'Pettifor', 'Affiliation': 'Department of Epidemiology, University of North Carolina at Chapel Hill, United States.'}, {'ForeName': 'Sheri A', 'Initials': 'SA', 'LastName': 'Lippman', 'Affiliation': 'Center for AIDS Prevention Studies, University of California, San Francisco, United States.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Kimaru', 'Affiliation': 'Department of Epidemiology, University of North Carolina at Chapel Hill, United States.'}, {'ForeName': 'Noah', 'Initials': 'N', 'LastName': 'Haber', 'Affiliation': 'Carolina Population Center, University of North Carolina at Chapel Hill, United States.'}, {'ForeName': 'Zola', 'Initials': 'Z', 'LastName': 'Mayakayaka', 'Affiliation': 'MRC/Wits Rural Public Health and Health Transitions Research Unit, School of Public Health, University of the Witwatersrand, South Africa.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Selin', 'Affiliation': 'Carolina Population Center, University of North Carolina at Chapel Hill, United States.'}, {'ForeName': 'Rhian', 'Initials': 'R', 'LastName': 'Twine', 'Affiliation': 'MRC/Wits Rural Public Health and Health Transitions Research Unit, School of Public Health, University of the Witwatersrand, South Africa.'}, {'ForeName': 'Hailey', 'Initials': 'H', 'LastName': 'Gilmore', 'Affiliation': 'Center for AIDS Prevention Studies, University of California, San Francisco, United States.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Westreich', 'Affiliation': 'Department of Epidemiology, University of North Carolina at Chapel Hill, United States.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Mdaka', 'Affiliation': 'MRC/Wits Rural Public Health and Health Transitions Research Unit, School of Public Health, University of the Witwatersrand, South Africa.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Wagner', 'Affiliation': 'MRC/Wits Rural Public Health and Health Transitions Research Unit, School of Public Health, University of the Witwatersrand, South Africa.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Gomez-Olive', 'Affiliation': 'MRC/Wits Rural Public Health and Health Transitions Research Unit, School of Public Health, University of the Witwatersrand, South Africa.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Tollman', 'Affiliation': 'MRC/Wits Rural Public Health and Health Transitions Research Unit, School of Public Health, University of the Witwatersrand, South Africa.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Kahn', 'Affiliation': 'MRC/Wits Rural Public Health and Health Transitions Research Unit, School of Public Health, University of the Witwatersrand, South Africa.'}]",EClinicalMedicine,['10.1016/j.eclinm.2020.100327'] 168,31586170,Comment on: A trial of a mechanical device for the treatment of blepharospasm.,,2020,,[],['mechanical device'],[],[],"[{'cui': 'C0443254', 'cui_str': 'Mechanical (qualifier value)'}, {'cui': 'C0220819', 'cui_str': 'devices'}]",[],,0.0269564,,"[{'ForeName': 'Jonathan A', 'Initials': 'JA', 'LastName': 'Go', 'Affiliation': 'Baylor College of Medicine, 1 Baylor Plaza, Houston, TX, 77030, USA.'}, {'ForeName': 'Ashley N', 'Initials': 'AN', 'LastName': 'Anderson', 'Affiliation': 'Baylor College of Medicine, 1 Baylor Plaza, Houston, TX, 77030, USA.'}, {'ForeName': 'Ashwini', 'Initials': 'A', 'LastName': 'Kini', 'Affiliation': 'Department of Ophthalmology, Blanton Eye Institute, Houston Methodist Hospital, 6550 Fannin St, Houston, TX, 77030, USA.'}, {'ForeName': 'Bayan', 'Initials': 'B', 'LastName': 'Al Othman', 'Affiliation': 'Department of Ophthalmology, Blanton Eye Institute, Houston Methodist Hospital, 6550 Fannin St, Houston, TX, 77030, USA.'}, {'ForeName': 'Andrew G', 'Initials': 'AG', 'LastName': 'Lee', 'Affiliation': 'Baylor College of Medicine, 1 Baylor Plaza, Houston, TX, 77030, USA. aglee@houstonmethodist.org.'}]","Eye (London, England)",['10.1038/s41433-019-0621-x'] 169,30707970,Soy isoflavones reduce asthma exacerbation in asthmatic patients with high PAI-1-producing genotypes.,"BACKGROUND The 4G4G genotype of plasminogen activator inhibitor 1 (PAI-1) is associated with increased plasma PAI-1 levels and poor asthma control. Previous studies suggest that soy isoflavones can reduce PAI-1 levels. OBJECTIVE We sought to investigate PAI-1 genotype-specific differences of the soy isoflavone response in asthma outcomes. METHODS A PAI-1 functional polymorphism (rs1799768, 4G5G) was characterized in subjects with poorly controlled asthma enrolled in a randomized clinical trial of soy isoflavones (n = 265). Genotype-specific treatment responses on asthma outcomes were compared between soy isoflavones and placebo. Normal human bronchial epithelial cells were cultured with or without TGF-β1, genistein, or both, and PAI-1 levels were measured. RESULTS The 4G4G/4G5G genotype was associated with a greater risk for allergy-related worsened asthma symptoms and eczema at baseline compared with the 5G5G genotype. There was a significant interaction between the genotype and soy isoflavone intervention on oral corticosteroid use for asthma exacerbation (P = .005). In a subgroup analysis soy isoflavones significantly reduced the use of oral corticosteroids (number of events/person-year) by 4-fold compared with placebo in the 4G4G/4G5G genotype (0.2 vs 0.8; relative risk, 0.28; P < .001) but not in the 5G5G genotype. Soy isoflavones reduced plasma PAI-1 levels compared with placebo. Genistein treatment reduced TGF-β1-induced PAI-1 production in normal human bronchial epithelial cells. CONCLUSIONS This study demonstrates that soy isoflavone treatment provides a significant benefit in reducing the number of severe asthma exacerbations in asthmatic patients with the high PAI-1-producing genotype. PAI-1 polymorphisms can be used as a genetic biomarker for soy isoflavone-responsive patients with asthma.",2019,The 4G4G/4G5G genotype was associated with a greater risk for allergy-related worsened asthma symptoms and eczema at baseline compared with the 5G5G genotype.,"['responsive patients with asthma', 'normal human bronchial epithelial cells', 'A PAI-1 functional polymorphism (rs1799768, 4G5G) was characterized in subjects with poorly controlled asthma enrolled', 'asthmatic patients with high PAI-1-producing genotypes', 'asthmatic patients with the high PAI-1-producing genotype']","['placebo', 'Genistein', 'soy isoflavones and placebo', 'soy isoflavone', 'soy isoflavones', 'soy isoflavone intervention', 'Soy isoflavones']","['Normal human bronchial epithelial cells', 'plasma PAI-1 levels', 'number of severe asthma exacerbations', 'TGF-β1-induced PAI-1 production', 'oral corticosteroids']","[{'cui': 'C0205342', 'cui_str': 'Responsive (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0205039', 'cui_str': 'Bronchial (qualifier value)'}, {'cui': 'C0014597', 'cui_str': 'Epithelial Cells'}, {'cui': 'C0030190', 'cui_str': 'SERPINE1 Protein'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0032529', 'cui_str': 'Polymorphism (Genetics)'}, {'cui': 'C3875152', 'cui_str': 'Characterizes'}, {'cui': 'C3853134', 'cui_str': 'Poorly controlled'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C1285573', 'cui_str': 'Genotype determination'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0061202', 'cui_str': 'Genistein'}, {'cui': 'C4076257', 'cui_str': 'Soy isoflavone (substance)'}]","[{'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0205039', 'cui_str': 'Bronchial (qualifier value)'}, {'cui': 'C0014597', 'cui_str': 'Epithelial Cells'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0030190', 'cui_str': 'SERPINE1 Protein'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0581126', 'cui_str': 'Severe asthma'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0033268'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}]",,0.185136,The 4G4G/4G5G genotype was associated with a greater risk for allergy-related worsened asthma symptoms and eczema at baseline compared with the 5G5G genotype.,"[{'ForeName': 'Seong H', 'Initials': 'SH', 'LastName': 'Cho', 'Affiliation': 'Division of Allergy-Immunology, Department of Internal Medicine, Morsani College of Medicine, University of South Florida, Tampa, Fla; Division of Rheumatology, Department of Internal Medicine, School of Medicine, Kyung Hee University, Seoul, Korea. Electronic address: scho2@health.usf.edu.'}, {'ForeName': 'Ara', 'Initials': 'A', 'LastName': 'Jo', 'Affiliation': 'Division of Allergy-Immunology, Department of Internal Medicine, Morsani College of Medicine, University of South Florida, Tampa, Fla.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Casale', 'Affiliation': 'Division of Allergy-Immunology, Department of Internal Medicine, Morsani College of Medicine, University of South Florida, Tampa, Fla.'}, {'ForeName': 'Su J', 'Initials': 'SJ', 'LastName': 'Jeong', 'Affiliation': 'Department of Statistics Support, Medical Science Research Institute, School of Medicine, Kyung Hee University, Seoul, Korea.'}, {'ForeName': 'Seung-Jae', 'Initials': 'SJ', 'LastName': 'Hong', 'Affiliation': 'Division of Rheumatology, Department of Internal Medicine, School of Medicine, Kyung Hee University, Seoul, Korea.'}, {'ForeName': 'Joong K', 'Initials': 'JK', 'LastName': 'Cho', 'Affiliation': 'Division of Allergy-Immunology, Department of Internal Medicine, Morsani College of Medicine, University of South Florida, Tampa, Fla.'}, {'ForeName': 'Janet T', 'Initials': 'JT', 'LastName': 'Holbrook', 'Affiliation': 'Center for Clinical Trials and Evidence Synthesis Bloomberg School of Public Health, Johns Hopkins University, Baltimore, Md.'}, {'ForeName': 'Rajesh', 'Initials': 'R', 'LastName': 'Kumar', 'Affiliation': 'Division of Allergy-Immunology, Department of Pediatrics, Feinberg School of Medicine, Northwestern University, Chicago, Ill.'}, {'ForeName': 'Lewis J', 'Initials': 'LJ', 'LastName': 'Smith', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Department of Medicine, Feinberg School of Medicine, Northwestern University, Chicago, Ill.'}]",The Journal of allergy and clinical immunology,['10.1016/j.jaci.2019.01.020'] 170,31548349,Plasma 25-Hydroxyvitamin D Levels and Survival in Patients with Advanced or Metastatic Colorectal Cancer: Findings from CALGB/SWOG 80405 (Alliance).,"PURPOSE Previous studies have suggested that higher circulating 25-hydroxyvitamin D [25(OH)D] levels are associated with decreased colorectal cancer risk and improved survival. However, the influence of vitamin D status on disease progression and patient survival remains largely unknown for patients with advanced or metastatic colorectal cancer. EXPERIMENTAL DESIGN We prospectively collected blood samples in 1,041 patients with previously untreated advanced or metastatic colorectal cancer participating in a randomized phase III clinical trial of first-line chemotherapy plus biologic therapy. We examined the association of baseline plasma 25(OH)D levels with overall survival (OS) and progression-free survival (PFS). Cox proportional hazards models were used to calculate hazard ratios (HRs) and confidence intervals (CIs), adjusted for prognostic factors and confounders. RESULTS At study entry, 63% of patients were vitamin D deficient (<20 ng/mL) and 31% were vitamin D insufficient (20-<30 ng/mL). Higher 25(OH)D levels were associated with an improvement in OS and PFS ( P trend = 0.0009 and 0.03, respectively). Compared with patients in the bottom quintile of 25(OH)D (≤10.8 ng/mL), those in the top quintile (≥24.1 ng/mL) had a multivariable-adjusted HR of 0.66 (95% CI, 0.53-0.83) for OS and 0.81 (95% CI, 0.66-1.00) for PFS. The improved survival associated with higher 25(OH)D levels was consistent across patient subgroups of prognostic patient and tumor characteristics. CONCLUSIONS In this large cohort of patients with advanced or metastatic colorectal cancer, higher plasma 25(OH)D levels were associated with improved OS and PFS. Clinical trials assessing the benefit of vitamin D supplementation in patients with colorectal cancer are warranted.",2019,"Higher 25(OH)D levels were associated with an improvement in OS and PFS ( P trend =0.0009 and 0.03, respectively).","['Patients with Advanced or Metastatic Colorectal Cancer', 'CRC patients', '1,041 patients with previously untreated advanced or metastatic CRC participating in a randomized phase III clinical trial of first-line', 'patients with advanced or metastatic CRC']","['chemotherapy plus biologic therapy', 'vitamin D supplementation']","['colorectal cancer (CRC) risk and improved survival', 'survival', 'Plasma 25-Hydroxyvitamin D Levels and Survival', 'circulating 25-hydroxyvitamin D [25(OH)D] levels', 'OS and PFS', 'Higher 25(OH)D levels', 'baseline plasma 25(OH)D levels with overall survival (OS) and progression-free survival (PFS', 'plasma 25(OH)D levels']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0346973', 'cui_str': 'Secondary malignant neoplasm of large intestine'}, {'cui': 'C0170127', 'cui_str': 'Calcibiotic Root Canal Sealer'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C1096780', 'cui_str': 'Clinical Trial, Phase 3'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}]","[{'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0005527', 'cui_str': 'Biologic Therapy'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}]","[{'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0535968', 'cui_str': '25-hydroxyvitamin D'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",1041.0,0.182611,"Higher 25(OH)D levels were associated with an improvement in OS and PFS ( P trend =0.0009 and 0.03, respectively).","[{'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Yuan', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute and Harvard Medical School, Boston, Massachusetts. chen_yuan@dfci.harvard.edu.'}, {'ForeName': 'Kaori', 'Initials': 'K', 'LastName': 'Sato', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute and Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Bruce W', 'Initials': 'BW', 'LastName': 'Hollis', 'Affiliation': 'Department of Pediatrics, Medical University of South Carolina, Charleston, South Carolina.'}, {'ForeName': 'Sui', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute and Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Niedzwiecki', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Duke University School of Medicine, Durham, North Carolina.'}, {'ForeName': 'Fang-Shu', 'Initials': 'FS', 'LastName': 'Ou', 'Affiliation': 'Alliance Statistics and Data Center, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'I-Wen', 'Initials': 'IW', 'LastName': 'Chang', 'Affiliation': 'Southeast Clinical Oncology Research (SCOR) Consortium, Winston-Salem, North Carolina.'}, {'ForeName': 'Bert H', 'Initials': 'BH', 'LastName': ""O'Neil"", 'Affiliation': 'Department of Medicine, Indiana University School of Medicine, Indianapolis, Indiana.'}, {'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Innocenti', 'Affiliation': 'Eshelman School of Pharmacy and Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.'}, {'ForeName': 'Heinz-Josef', 'Initials': 'HJ', 'LastName': 'Lenz', 'Affiliation': 'Division of Medical Oncology, Norris Comprehensive Cancer Center, Keck School of Medicine, University of Southern California, Los Angeles, California.'}, {'ForeName': 'Charles D', 'Initials': 'CD', 'LastName': 'Blanke', 'Affiliation': ""SWOG Group Chair's Office/Knight Cancer Institute, Oregon Health and Science University, Portland, Oregon.""}, {'ForeName': 'Richard M', 'Initials': 'RM', 'LastName': 'Goldberg', 'Affiliation': 'West Virginia University Cancer Institute, Morgantown, West Virginia.'}, {'ForeName': 'Alan P', 'Initials': 'AP', 'LastName': 'Venook', 'Affiliation': 'Department of Medicine, University of California San Francisco (UCSF) School of Medicine, San Francisco, California.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Mayer', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute and Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Charles S', 'Initials': 'CS', 'LastName': 'Fuchs', 'Affiliation': 'Yale Cancer Center and Smilow Cancer Hospital, New Haven, Connecticut.'}, {'ForeName': 'Jeffrey A', 'Initials': 'JA', 'LastName': 'Meyerhardt', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute and Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Kimmie', 'Initials': 'K', 'LastName': 'Ng', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute and Harvard Medical School, Boston, Massachusetts.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-19-0877'] 171,32328912,Effects of a Decision-Making Intervention to Help Decide Whether to Disclose HIV-Positive Status to Family Members on Well-Being and Sexual Behavior.,"An HIV diagnosis is often followed by uncertainty, questions over next steps, and concerns over how to share the diagnosis with others. The goal of the current study was to investigate the effects of an intervention designed to help people living with HIV decide whether or not they want to disclose their status to family members (i.e., decision-making process rather than actual disclosure) and the subsequent decision on their well-being and sexual behavior. Additionally, differences in outcomes among men who have sex with men (MSM), heterosexual men (HSM), and women were examined. A total of 346 women and men living in the Southeastern part of the United States. Participated in the study, which consisted of a baseline assessment, followed by randomization into either the disclosure intervention or attention control case management group. Both treatments consisted of seven sessions over a 12-month period. Results from repeated measures ANOVA indicated that although there was no significant intervention effect, participants in both groups reported some improvements in well-being and decreases in risky sexual behavior. However, no consistent differences in outcomes emerged among MSM, HSM, and women. Assisting with the disclosure decision-making process and reducing HIV transmission risk should continue to be an essential focus in future research endeavors and for frontline professionals dedicated to HIV-related care and prevention.",2020,"Results from repeated measures ANOVA indicated that although there was no significant intervention effect, participants in both groups reported some improvements in well-being and decreases in risky sexual behavior.","['346 women and men living in the Southeastern part of the United States', 'men who have sex with men (MSM), heterosexual men (HSM), and women were examined']","['Decision-Making Intervention', 'disclosure intervention or attention control case management group']",['risky sexual behavior'],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}, {'cui': 'C0019421', 'cui_str': 'Heterosexuality'}, {'cui': 'C0332128', 'cui_str': 'Examined for'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0012625', 'cui_str': 'Information Disclosure'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0085971', 'cui_str': 'Case management'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0036864', 'cui_str': 'Sexual behavior'}]",346.0,0.0273878,"Results from repeated measures ANOVA indicated that although there was no significant intervention effect, participants in both groups reported some improvements in well-being and decreases in risky sexual behavior.","[{'ForeName': 'Julianne M', 'Initials': 'JM', 'LastName': 'Serovich', 'Affiliation': 'College of Behavioral and Community Sciences, University of South Florida, Tampa, FL, 33612, USA. jserovich@usf.edu.'}, {'ForeName': 'Tanja C', 'Initials': 'TC', 'LastName': 'Laschober', 'Affiliation': 'College of Behavioral and Community Sciences, University of South Florida, Tampa, FL, 33612, USA.'}, {'ForeName': 'Monique J', 'Initials': 'MJ', 'LastName': 'Brown', 'Affiliation': 'Department of Epidemiology and Biostatistics, Arnold School of Public Health, University of South Carolina, Columbia, SC, USA.'}, {'ForeName': 'Judy A', 'Initials': 'JA', 'LastName': 'Kimberly', 'Affiliation': 'Division of Biology and Medicine, Brown University, Providence, RI, USA.'}, {'ForeName': 'Celia M', 'Initials': 'CM', 'LastName': 'Lescano', 'Affiliation': 'Department of Mental Health Law and Policy, College of Behavioral and Community Sciences, University of South Florida, Tampa, FL, USA.'}]",Archives of sexual behavior,['10.1007/s10508-020-01703-0'] 172,32320285,Dexamethasone Sodium Phosphate Penetration During Phonophoresis at 2 Ultrasound Frequencies.,"CONTEXT The effect of ultrasound frequency on phonophoresis drug delivery in humans is unknown. OBJECTIVE To determine if a low (45-kHz) or high (1-MHz) frequency delivered a higher dexamethasone (Dex) concentration through the skin. DESIGN Controlled laboratory study. SETTING Laboratory. PATIENTS OR OTHER PARTICIPANTS A total of 40 healthy men between the ages of 18 and 45 years (age = 23.1 ± 2.6 years, height = 176.1 ± 7.2 cm, mass = 88.5 ± 19.4 kg, posterior calf subcutaneous thickness measured using musculoskeletal ultrasound imaging = 0.6 ± 0.2 cm). INTERVENTION(S) Participants were randomly assigned to 1 of 4 groups (ultrasound frequency at microdialysis probe depth): (1) 45-kHz frequency at 1 mm, (2) 45-kHz frequency at 4 mm, (3) 1-MHz frequency at 1 mm, or (4) 1-MHz frequency at 4 mm (n = 10 in each group). Three linear microdialysis probes were inserted at the desired tissue depth. We rubbed dexamethasone sodium phosphate (Dex-P) into the skin and then applied a 15-minute phonophoresis treatment. MAIN OUTCOME MEASURE(S) Dialysate was collected during the treatment and 60 minutes posttreatment and analyzed for Dex-P, Dex, and the metabolite form of Dex. The sum of the 3 analytes was calculated as total dexamethasone (Dex-total), and differences between the 45-kHz and 1-MHz treatment groups were determined by a repeated-measures analysis of variance. RESULTS At 1 mm, 3 (30%) participants in the 45-kHz and 4 (40%) participants in the 1-MHz group had measurable levels of Dex-P. Total dexamethasone increased after the treatment ceased, independent of ultrasound frequency (P < .001), with a trend of the 45-kHz treatment to produce a greater increase in drug concentration (P = .006). At 4 mm, 5 (50%) participants in the 45-kHz and 1 (10%) participant in the 1-MHz group had measurable levels of Dex-P. We observed no difference in Dex-total concentration between treatment groups at 4 mm (P = .72). CONCLUSIONS Phonophoresis provided a mechanism for Dex-total delivery at the 1- and 4-mm tissue depths. However, the effectiveness of the ultrasound frequencies varied between the 2 measured tissue depths.",2020,"P < .001), with a trend of the 45-kHz treatment to produce a greater increase in drug concentration ( P = .006).","['40 healthy men between the ages of 18 and 45 years (age = 23.1 ± 2.6 years, height = 176.1 ± 7.2 cm, mass = 88.5 ± 19.4 kg, posterior calf subcutaneous thickness measured using musculoskeletal imaging ultrasound = 0.6 ± 0.2 cm']","['Dexamethasone Sodium Phosphate Penetration', 'low (45-kHz) or high (1-MHz) frequency delivered a higher dexamethasone (Dex', 'dexamethasone sodium phosphate (Dex-P']","['Dialysate', 'measurable levels of Dex-P', 'measurable levels of Dex-P. Total dexamethasone', 'total dexamethasone (Dex-total', 'drug concentration', 'Dex-total concentration', 'ultrasound frequency ']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517633', 'cui_str': '2.6'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C4517857', 'cui_str': '7.2'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C4709305', 'cui_str': '19.4'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0230445', 'cui_str': 'Structure of calf of leg'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C4068883', 'cui_str': '0.6'}, {'cui': 'C4517436', 'cui_str': '0.2'}]","[{'cui': 'C0113286', 'cui_str': 'Dexamethasone sodium phosphate'}, {'cui': 'C0205321', 'cui_str': 'Penetrating'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0556965', 'cui_str': 'kHz'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0556962', 'cui_str': 'MHz'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}]","[{'cui': 'C0011947', 'cui_str': 'Dialysis fluid'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}]",40.0,0.0591625,"P < .001), with a trend of the 45-kHz treatment to produce a greater increase in drug concentration ( P = .006).","[{'ForeName': 'Justin H', 'Initials': 'JH', 'LastName': 'Rigby', 'Affiliation': 'University of Utah, Salt Lake City.'}, {'ForeName': 'Austin M', 'Initials': 'AM', 'LastName': 'Hagan', 'Affiliation': 'Texas State University, San Marcos.'}, {'ForeName': 'Austin R', 'Initials': 'AR', 'LastName': 'Kelcher', 'Affiliation': 'Texas State University, San Marcos.'}, {'ForeName': 'Chang', 'Initials': 'C', 'LastName': 'Ji', 'Affiliation': 'Texas State University, San Marcos.'}]",Journal of athletic training,['10.4085/1062-6050-556-18'] 173,31427252,"Efficacy of oral amoxicillin-clavulanate or azithromycin for non-severe respiratory exacerbations in children with bronchiectasis (BEST-1): a multicentre, three-arm, double-blind, randomised placebo-controlled trial.","BACKGROUND Bronchiectasis guidelines recommend antibiotics for the treatment of acute respiratory exacerbations, but randomised placebo-controlled trials in children are lacking. We hypothesised that oral amoxicillin-clavulanate and azithromycin would each be superior to placebo in achieving symptom resolution of non-severe exacerbations in children by day 14 of treatment. METHODS In this multicentre, three-arm, parallel, double-dummy, double-blind, randomised placebo-controlled trial at four paediatric centres in Australia and New Zealand, we enrolled children aged 1-18 years with CT-confirmed bronchiectasis unrelated to cystic fibrosis, who were under the care of a respiratory physician and who had had at least two respiratory exacerbations in the 18 months before study entry. Participants were allocated (1:1:1) at exacerbation onset to receive oral suspensions of amoxicillin-clavulanate (45 mg/kg per day) plus placebo azithromycin, azithromycin (5 mg/kg per day) plus placebo amoxicillin-clavulanate, or both placebos for 14 days. An independent statistician prepared a computer-generated, permuted-block (size 2-8) randomisation sequence, stratified by centre, age, and cause. Participants, caregivers, study coordinators, and investigators were masked to treatment assignment until data analysis was completed. The primary outcome was the proportion of children with exacerbation resolution by day 14 in the intention-to-treat population. Treatment groups were compared using generalised linear models. Statistical significance was set at p<0·0245 to account for multiple comparisons. This trial is registered with the Australian New Zealand Clinical Trials Registry (ACTRN12612000011886) and is completed. FINDINGS Between April 17, 2012, and March 1, 2017, 604 children were screened and 252 were enrolled. Between July 31, 2012, and June 26, 2017, 197 children were allocated at the start of an exacerbation (63 to the amoxicillin-clavulanate group, 67 to the azithromycin group, and 67 to the placebo group). Respiratory viruses were identified in 82 (53%) of 154 children with available nasal swabs on day 1 of treatment. Primary outcome data were available for 196 (99%) children (one child with missing data [placebo group] was recorded as non-resolved according to criteria defined a priori). By day 14, exacerbations had resolved in 41 (65%) children in the amoxicillin-clavulanate group, 41 (61%) in the azithromycin group, and 29 (43%) in the placebo group. Compared with placebo, relative risk for resolution by day 14 was 1·50 (95% CI 1·08-2·09, p=0·015; number-needed-to-treat [NNT] 5 [95% CI 3-20]) in the amoxicillin-clavulanate group and 1·41 (1·01-1·97, p=0·042; NNT 6 [3-79]) in the azithromycin group. Adverse events were recorded in 19 (30%) children in the amoxicillin-clavulanate group, 20 (30%) in the azithromycin group, and 14 (21%) in the placebo group, but no events were severe or life-threatening. INTERPRETATION Amoxicillin-clavulanate treatment is beneficial in terms of resolution of non-severe exacerbations of bronchiectasis in children, and should remain the first-line oral antibiotic in this setting. FUNDING National Health and Medical Research Council (Australia), Cure Kids (New Zealand).",2019,Respiratory viruses were identified in 82 (53%) of 154 children with available nasal swabs on day 1 of treatment.,"['154 children with available nasal swabs on day 1 of treatment', 'controlled trial at four paediatric centres in Australia and New Zealand, we enrolled children aged 1-18 years with CT-confirmed bronchiectasis unrelated to cystic fibrosis, who were under the care of a respiratory physician and who had had at least two respiratory exacerbations in the 18 months before study entry', 'Between April 17, 2012, and March 1, 2017, 604 children were screened and 252 were enrolled', 'children with bronchiectasis (BEST-1', 'Between July 31, 2012, and June 26, 2017, 197 children were allocated at the start of an exacerbation (63 to the']","['placebo', 'placebo azithromycin, azithromycin', 'amoxicillin-clavulanate', 'amoxicillin-clavulanate and azithromycin', 'amoxicillin', 'oral suspensions of amoxicillin-clavulanate', 'azithromycin', 'oral amoxicillin-clavulanate or azithromycin', 'placebo amoxicillin-clavulanate, or both placebos', 'Amoxicillin-clavulanate treatment']","[' number-needed-to-treat [NNT', 'Adverse events', 'proportion of children with exacerbation resolution', 'severe or life-threatening']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C4520890', 'cui_str': 'Nasal'}, {'cui': 'C1261188', 'cui_str': 'Swab (physical object)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0006267', 'cui_str': 'Bronchiectasis'}, {'cui': 'C0445356', 'cui_str': 'Unrelated (finding)'}, {'cui': 'C0010674', 'cui_str': 'Mucoviscidosis'}, {'cui': 'C0043237', 'cui_str': 'WHO'}, {'cui': 'C0586859', 'cui_str': 'Pulmonologists'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C1272689', 'cui_str': 'Started'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C0002645', 'cui_str': 'Amoxicillin'}, {'cui': 'C0110038', 'cui_str': 'Clavulanate'}, {'cui': 'C0991537', 'cui_str': 'Oral Suspension'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C3179138', 'cui_str': 'Numbers Needed To Treat'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0376558', 'cui_str': 'Life'}]",604.0,0.726983,Respiratory viruses were identified in 82 (53%) of 154 children with available nasal swabs on day 1 of treatment.,"[{'ForeName': 'Vikas', 'Initials': 'V', 'LastName': 'Goyal', 'Affiliation': ""Department of Respiratory and Sleep Medicine, Queensland Children's Hospital, Brisbane, QLD, Australia; Department of Paediatrics, Gold Coast Health, Gold Coast, QLD, Australia; School of Medicine, The University of Queensland Brisbane, QLD, Australia; Centre for Children's Health Research, Queensland University of Technology, Brisbane, QLD, Australia. Electronic address: drvikasgoyal@gmail.com.""}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Grimwood', 'Affiliation': 'Department of Paediatrics, Gold Coast Health, Gold Coast, QLD, Australia; Department of Infectious Diseases, Gold Coast Health, Gold Coast, QLD, Australia; School of Medicine, Griffith University, Gold Coast, QLD, Australia; Menzies Health Institute Queensland, Griffith University, Gold Coast, QLD, Australia.'}, {'ForeName': 'Robert S', 'Initials': 'RS', 'LastName': 'Ware', 'Affiliation': 'Menzies Health Institute Queensland, Griffith University, Gold Coast, QLD, Australia.'}, {'ForeName': 'Catherine A', 'Initials': 'CA', 'LastName': 'Byrnes', 'Affiliation': ""Department of Paediatrics, University of Auckland, Auckland, New Zealand; Respiratory Department, Starship Children's Hospital, Auckland, New Zealand.""}, {'ForeName': 'Peter S', 'Initials': 'PS', 'LastName': 'Morris', 'Affiliation': 'Menzies School of Health Research, Charles Darwin University, Darwin, NT, Australia; Department of Paediatrics, Royal Darwin Hospital, Darwin, NT, Australia.'}, {'ForeName': 'I Brent', 'Initials': 'IB', 'LastName': 'Masters', 'Affiliation': ""Department of Respiratory and Sleep Medicine, Queensland Children's Hospital, Brisbane, QLD, Australia; Centre for Children's Health Research, Queensland University of Technology, Brisbane, QLD, Australia.""}, {'ForeName': 'Gabrielle B', 'Initials': 'GB', 'LastName': 'McCallum', 'Affiliation': 'Child Health Division, Charles Darwin University, Darwin, NT, Australia.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Binks', 'Affiliation': 'Child Health Division, Charles Darwin University, Darwin, NT, Australia.'}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Smith-Vaughan', 'Affiliation': 'School of Medicine, Griffith University, Gold Coast, QLD, Australia; Child Health Division, Charles Darwin University, Darwin, NT, Australia.'}, {'ForeName': 'Kerry-Ann F', 'Initials': 'KF', 'LastName': ""O'Grady"", 'Affiliation': ""Centre for Children's Health Research, Queensland University of Technology, Brisbane, QLD, Australia.""}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Champion', 'Affiliation': ""Pharmacy Department, Queensland Children's Hospital, Brisbane, QLD, Australia.""}, {'ForeName': 'Helen M', 'Initials': 'HM', 'LastName': 'Buntain', 'Affiliation': ""Department of Respiratory and Sleep Medicine, Queensland Children's Hospital, Brisbane, QLD, Australia.""}, {'ForeName': 'André', 'Initials': 'A', 'LastName': 'Schultz', 'Affiliation': ""Telethon Kids Institute, Perth, WA, Australia; Division of Paediatrics, School of Medicine, University of Western Australia, Perth, WA, Australia; Department of Respiratory and Sleep Medicine, Perth Children's Hospital, Perth, WA, Australia.""}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Chatfield', 'Affiliation': 'Centre for Health Services Research, Faculty of Medicine, The University of Queensland Brisbane, QLD, Australia.'}, {'ForeName': 'Paul J', 'Initials': 'PJ', 'LastName': 'Torzillo', 'Affiliation': 'Central Clinical School, University of Sydney, Sydney, NSW, Australia; Department of Respiratory Medicine, Royal Prince Alfred Hospital, Sydney, NSW, Australia.'}, {'ForeName': 'Anne B', 'Initials': 'AB', 'LastName': 'Chang', 'Affiliation': ""Department of Respiratory and Sleep Medicine, Queensland Children's Hospital, Brisbane, QLD, Australia; Centre for Children's Health Research, Queensland University of Technology, Brisbane, QLD, Australia; Menzies School of Health Research, Charles Darwin University, Darwin, NT, Australia.""}]",The Lancet. Respiratory medicine,['10.1016/S2213-2600(19)30254-1'] 174,31794974,One-year clinical outcomes following theta burst stimulation for post-traumatic stress disorder.,"Theta burst transcranial magnetic stimulation (TBS) is a potential new treatment for post-traumatic stress disorder (PTSD). We previously reported active intermittent TBS (iTBS) was associated with superior clinical outcomes for up to 1-month, in a sample of fifty veterans with PTSD, using a crossover design. In that study, participants randomized to the active group received a total of 4-weeks of active iTBS, or 2-weeks if randomized to sham. Results were superior with greater exposure to active iTBS, which raised the question of whether observed effects persisted over the longer-term. This study reviewed naturalistic outcomes up to 1-year from study endpoint, to test the hypothesis that greater exposure to active iTBS would be associated with superior outcomes. The primary outcome measure was clinical relapse, defined as any serious adverse event (e.g., suicide, psychiatric hospitalization, etc.,) or need for retreatment with repetitive transcranial magnetic stimulation (rTMS). Forty-six (92%) of the initial study's intent-to-treat participants were included. Mean age was 51.0 ± 12.3 years and seven (15.2%) were female. The group originally randomized to active iTBS (4-weeks active iTBS) demonstrated superior outcomes at one year compared to those originally randomized to sham (2-weeks active iTBS); log-rank ChiSq = 5.871, df = 1, p = 0.015; OR = 3.50, 95% CI = 1.04-11.79. Mean days to relapse were 296.0 ± 22.1 in the 4-week group, and 182.0 ± 31.9 in the 2-week group. When used, rTMS retreatment was generally effective. Exploratory neuroimaging revealed default mode network connectivity was predictive of 1-year outcomes (corrected p < 0.05). In summary, greater accumulated exposure to active iTBS demonstrated clinically meaningful improvements in the year following stimulation, and default mode connectivity could be used to predict longer-term outcomes.",2020,"The group originally randomized to active iTBS (4-weeks active iTBS) demonstrated superior outcomes at one year compared to those originally randomized to sham (2-weeks active iTBS); log-rank ChiSq = 5.871, df = 1, p = 0.015; OR = 3.50, 95% CI = 1.04-11.79.","['post-traumatic stress disorder (PTSD', 'Mean age was 51.0\u2009±\u200912.3 years and seven (15.2%) were female', 'fifty veterans with PTSD', ""Forty-six (92%) of the initial study's intent-to-treat participants were included""]","['total of 4-weeks of active iTBS', 'active iTBS (4-weeks active iTBS', 'theta burst stimulation', 'active intermittent TBS (iTBS', 'Theta burst transcranial magnetic stimulation (TBS', 'TMS']","['clinical relapse, defined as any serious adverse event (e.g., suicide, psychiatric hospitalization, etc.,) or need for retreatment with repetitive transcranial magnetic stimulation (rTMS', 'Mean days to relapse']","[{'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1283828', 'cui_str': 'Intentional'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0205267', 'cui_str': 'Intermittent (qualifier value)'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation (procedure)'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0852733', 'cui_str': 'Suicide (accomplished)'}, {'cui': 'C0205487', 'cui_str': 'Psychiatric (qualifier value)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}, {'cui': 'C0376495', 'cui_str': 'Retreatments'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]",50.0,0.149203,"The group originally randomized to active iTBS (4-weeks active iTBS) demonstrated superior outcomes at one year compared to those originally randomized to sham (2-weeks active iTBS); log-rank ChiSq = 5.871, df = 1, p = 0.015; OR = 3.50, 95% CI = 1.04-11.79.","[{'ForeName': 'Nicholas J', 'Initials': 'NJ', 'LastName': 'Petrosino', 'Affiliation': 'From the VA RR&D Center for Neurorestoration and Neurotechnology, Providence VA Medical Center, and The Department of Psychiatry and Human Behavior, Alpert Medical School of Brown University, Providence, RI, 02903, USA.'}, {'ForeName': ""Mascha van 't"", 'Initials': ""MV'"", 'LastName': 'Wout-Frank', 'Affiliation': 'From the VA RR&D Center for Neurorestoration and Neurotechnology, Providence VA Medical Center, and The Department of Psychiatry and Human Behavior, Alpert Medical School of Brown University, Providence, RI, 02903, USA.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Aiken', 'Affiliation': 'From the VA RR&D Center for Neurorestoration and Neurotechnology, Providence VA Medical Center, and The Department of Psychiatry and Human Behavior, Alpert Medical School of Brown University, Providence, RI, 02903, USA.'}, {'ForeName': 'Hannah R', 'Initials': 'HR', 'LastName': 'Swearingen', 'Affiliation': 'From the VA RR&D Center for Neurorestoration and Neurotechnology, Providence VA Medical Center, and The Department of Psychiatry and Human Behavior, Alpert Medical School of Brown University, Providence, RI, 02903, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Barredo', 'Affiliation': 'From the VA RR&D Center for Neurorestoration and Neurotechnology, Providence VA Medical Center, and The Department of Psychiatry and Human Behavior, Alpert Medical School of Brown University, Providence, RI, 02903, USA.'}, {'ForeName': 'Amin', 'Initials': 'A', 'LastName': 'Zandvakili', 'Affiliation': 'From the VA RR&D Center for Neurorestoration and Neurotechnology, Providence VA Medical Center, and The Department of Psychiatry and Human Behavior, Alpert Medical School of Brown University, Providence, RI, 02903, USA.'}, {'ForeName': 'Noah S', 'Initials': 'NS', 'LastName': 'Philip', 'Affiliation': 'From the VA RR&D Center for Neurorestoration and Neurotechnology, Providence VA Medical Center, and The Department of Psychiatry and Human Behavior, Alpert Medical School of Brown University, Providence, RI, 02903, USA. noah_philip@brown.edu.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0584-4'] 175,32092760,Modulation of the antidepressant effects of ketamine by the mTORC1 inhibitor rapamycin.,"Twenty-four hours after administration, ketamine exerts rapid and robust antidepressant effects that are thought to be mediated by activation of the mechanistic target of rapamycin complex 1 (mTORC1). To test this hypothesis, depressed patients were pretreated with rapamycin, an mTORC1 inhibitor, prior to receiving ketamine. Twenty patients suffering a major depressive episode were randomized to pretreatment with oral rapamycin (6 mg) or placebo 2 h prior to the intravenous administration of ketamine 0.5 mg/kg in a double-blind cross-over design with treatment days separated by at least 2 weeks. Depression severity was assessed using Montgomery-Åsberg Depression Rating Scale (MADRS). Rapamycin pretreatment did not alter the antidepressant effects of ketamine at the 24-h timepoint. Over the subsequent 2-weeks, we found a significant treatment by time interaction (F (8,245)  = 2.02, p = 0.04), suggesting a prolongation of the antidepressant effects of ketamine by rapamycin. Two weeks following ketamine administration, we found higher response (41%) and remission rates (29%) following rapamycin + ketamine compared to placebo + ketamine (13%, p = 0.04, and 7%, p = 0.003, respectively). In summary, single dose rapamycin pretreatment failed to block the antidepressant effects of ketamine, but it prolonged ketamine's antidepressant effects. This observation raises questions about the role of systemic vs. local blockade of mTORC1 in the antidepressant effects of ketamine, provides preliminary evidence that rapamycin may extend the benefits of ketamine, and thereby potentially sheds light on mechanisms that contribute to depression relapse after ketamine administration.",2020,"Two weeks following ketamine administration, we found higher response (41%) and remission rates (29%) following rapamycin + ketamine compared to placebo + ketamine (13%, p = 0.04, and 7%, p = 0.003, respectively).",['Twenty patients suffering a major depressive episode'],"['rapamycin\u2009+\u2009ketamine', 'placebo', 'ketamine', 'Rapamycin', 'rapamycin', 'placebo\u2009+\u2009ketamine', 'rapamycin, an mTORC1 inhibitor, prior to receiving ketamine', 'oral rapamycin']","['remission rates', 'Montgomery-Åsberg Depression Rating Scale (MADRS', 'Depression severity']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0349217', 'cui_str': 'Depressive episode'}]","[{'cui': 'C0072980', 'cui_str': 'Sirolimus'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3888046', 'cui_str': 'mTORC1 Complex'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}]","[{'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C2960593', 'cui_str': 'Montgomery-Åsberg depression rating scale'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}]",,0.0810233,"Two weeks following ketamine administration, we found higher response (41%) and remission rates (29%) following rapamycin + ketamine compared to placebo + ketamine (13%, p = 0.04, and 7%, p = 0.003, respectively).","[{'ForeName': 'Chadi G', 'Initials': 'CG', 'LastName': 'Abdallah', 'Affiliation': 'National Center for PTSD - Clinical Neurosciences Division, US Department of Veterans Affairs, West Haven, CT, USA. chadi.abdallah@yale.edu.'}, {'ForeName': 'Lynnette A', 'Initials': 'LA', 'LastName': 'Averill', 'Affiliation': 'National Center for PTSD - Clinical Neurosciences Division, US Department of Veterans Affairs, West Haven, CT, USA.'}, {'ForeName': 'Ralitza', 'Initials': 'R', 'LastName': 'Gueorguieva', 'Affiliation': 'Department of Biostatistics, Yale University School of Public Health, New Haven, CT, USA.'}, {'ForeName': 'Selin', 'Initials': 'S', 'LastName': 'Goktas', 'Affiliation': 'National Center for PTSD - Clinical Neurosciences Division, US Department of Veterans Affairs, West Haven, CT, USA.'}, {'ForeName': 'Prerana', 'Initials': 'P', 'LastName': 'Purohit', 'Affiliation': 'National Center for PTSD - Clinical Neurosciences Division, US Department of Veterans Affairs, West Haven, CT, USA.'}, {'ForeName': 'Mohini', 'Initials': 'M', 'LastName': 'Ranganathan', 'Affiliation': 'Departments of Psychiatry, Neuroscience, and Psychology Yale University, New Haven, CT, USA.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Sherif', 'Affiliation': 'Departments of Psychiatry, Neuroscience, and Psychology Yale University, New Haven, CT, USA.'}, {'ForeName': 'Kyung-Heup', 'Initials': 'KH', 'LastName': 'Ahn', 'Affiliation': 'Departments of Psychiatry, Neuroscience, and Psychology Yale University, New Haven, CT, USA.'}, {'ForeName': 'Deepak Cyril', 'Initials': 'DC', 'LastName': ""D'Souza"", 'Affiliation': 'Departments of Psychiatry, Neuroscience, and Psychology Yale University, New Haven, CT, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Formica', 'Affiliation': 'Department of Internal Medicine, Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Steven M', 'Initials': 'SM', 'LastName': 'Southwick', 'Affiliation': 'National Center for PTSD - Clinical Neurosciences Division, US Department of Veterans Affairs, West Haven, CT, USA.'}, {'ForeName': 'Ronald S', 'Initials': 'RS', 'LastName': 'Duman', 'Affiliation': 'National Center for PTSD - Clinical Neurosciences Division, US Department of Veterans Affairs, West Haven, CT, USA.'}, {'ForeName': 'Gerard', 'Initials': 'G', 'LastName': 'Sanacora', 'Affiliation': 'National Center for PTSD - Clinical Neurosciences Division, US Department of Veterans Affairs, West Haven, CT, USA.'}, {'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'Krystal', 'Affiliation': 'National Center for PTSD - Clinical Neurosciences Division, US Department of Veterans Affairs, West Haven, CT, USA.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-020-0644-9'] 176,32298025,A cost-effectiveness analysis comparing a conventional mechanical needle to a radiofrequency device for transseptal punctures.,"INTRODUCTION Transseptal puncture is an integral step in various catheter-based cardiac procedures and can be performed with either the conventional mechanical needle or an FDA-cleared device utilizing radiofrequency (RF) energy. Although a previous randomized trial suggested that the RF transseptal device may be faster and more often successful, the increased equipment costs may dissuade operators from routine use. This analysis compares the cost-effectiveness of the mechanical needle to the RF device during pulmonary vein isolation. METHODS The rates of successful transseptal punctures for each device and transseptal-related complications were determined from the peer-reviewed medical literature. Procedural, equipment, and complication costs were obtained from peer-reviewed medical literature and the Healthcare Cost and Utilization Project. The effectiveness was defined as the probability of 30-day survival following a successful transseptal puncture. Monte Carlo probabilistic analyses tested variable effects of costs and complication rates on the incremental cost-effectiveness ratio. RESULTS The 30-day effectiveness of the RF device vs the mechanical needle was 99.7% and 98.8%, respectively. After accounting for all costs of performing a single transseptal puncture, the cost at 30 days associated with the RF device was $41 less than the mechanical needle ($21 096 vs $21 137). The RF device was similarly dominant to the mechanical needle in double transseptal puncture scenarios. Finally, the RF device was more cost-effective than the mechanical needle at any willingness-to-pay in Monte Carlo probabilistic sensitivity analyses. CONCLUSIONS Despite greater equipment costs, the RF device costs less and provides better effectiveness at 30 days than the conventional mechanical needle.",2020,"Finally, the RF device was more cost-effective than the mechanical needle at any willingness-to-pay in Monte-Carlo probabilistic sensitivity analyses. ",[],"['RF transseptal device', 'RF device vs. the mechanical needle', 'mechanical needle to the RF device', 'conventional mechanical needle or an FDA-cleared device utilizing radiofrequency (RF) energy', 'Conventional Mechanical Needle to a Radiofrequency Device']","['Procedural, equipment, and complication costs', 'cost-effective', 'incremental cost-effectiveness ratio (ICER', '30-day effectiveness', 'cost-effectiveness', 'costs and complication rates', 'probability of 30-day survival', 'rates of successful transseptal punctures', 'RF device']",[],"[{'cui': 'C0442381', 'cui_str': 'Transseptal nasal approach'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0007431', 'cui_str': 'Insertion of catheter into artery'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0041714', 'cui_str': 'United States Food, Drug Administration'}]","[{'cui': 'C0014672', 'cui_str': 'Equipment'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0442381', 'cui_str': 'Transseptal nasal approach'}, {'cui': 'C0033119', 'cui_str': 'Puncture'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]",,0.0363538,"Finally, the RF device was more cost-effective than the mechanical needle at any willingness-to-pay in Monte-Carlo probabilistic sensitivity analyses. ","[{'ForeName': 'José M', 'Initials': 'JM', 'LastName': 'Sanchez', 'Affiliation': 'Section of Cardiac Electrophysiology, Division of Cardiology, University of California, San Francisco, California.'}, {'ForeName': 'Rahil', 'Initials': 'R', 'LastName': 'Shah', 'Affiliation': 'Department of Clinical Pharmacy, University of California, San Francisco, California.'}, {'ForeName': 'Yao', 'Initials': 'Y', 'LastName': 'Kouassi', 'Affiliation': 'Department of Clinical Pharmacy, University of California, San Francisco, California.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Chronowic', 'Affiliation': 'Baylis Medical Company, Mississauga, Ontario, Canada.'}, {'ForeName': 'Leslie', 'Initials': 'L', 'LastName': 'Wilson', 'Affiliation': 'Department of Clinical Pharmacy, University of California, San Francisco, California.'}, {'ForeName': 'Gregory M', 'Initials': 'GM', 'LastName': 'Marcus', 'Affiliation': 'Section of Cardiac Electrophysiology, Division of Cardiology, University of California, San Francisco, California.'}]",Journal of cardiovascular electrophysiology,['10.1111/jce.14500'] 177,32298272,Can rhythm-induced attention improve the perceptual representation?,"Temporal attention can be entrained exogenously to rhythms. Indeed, faster and more accurate responses were previously found when the target appeared in-phase with a preceding rhythm in comparison to when it was out of phase. However, the nature of this rhythm-induced attentional effect is not well understood. To better understand the processes underlying rhythm-induced attention, we employed a continuous measure of perceived orientation and a mixture-model analysis. A trial in our study started with a sequence of auditory beeps separated by a fixed inter-beeps interval in the regular (rhythmic) condition or by variable inter-beeps intervals in the irregular condition. A visual target-a line embedded in a circle-followed the sequence. The 'critical' interval between the last beep and the target was chosen randomly from several possible Inter-Onset Intervals (IOIs), of which only one was in-phase with the rhythm. The target was followed by a probe line, and the participants were asked to rotate it to reproduce the target's orientation. The measure of performance for a given trial was the difference in degrees between the orientation of the target and that reproduced by the observer. We found that guessing rate was lower with regular than irregular rhythms. However, there was no effect of rhythm type (regular vs irregular) on the quality of representation (measured as the variability in reproducing the target). Furthermore, the rhythm effect was present only when rhythm type was fixed within a block, and it was found with all IOIs, not just the in-phase IOI. This lack of specificity suggests that these results reflect a general effect of rhythm on alertness.",2020,"However, there was no effect of rhythm type (regular vs irregular) on the quality of representation (measured as the variability in reproducing the target).",[],[],"['guessing rate', 'quality of representation']",[],[],"[{'cui': 'C0332306', 'cui_str': 'Quality'}]",,0.0298252,"However, there was no effect of rhythm type (regular vs irregular) on the quality of representation (measured as the variability in reproducing the target).","[{'ForeName': 'Asaf', 'Initials': 'A', 'LastName': 'Elbaz', 'Affiliation': 'Department of Psychology & Institute of Information Processing and Decision Making, University of Haifa, Mount Carmel, Haifa, Israel.'}, {'ForeName': 'Yaffa', 'Initials': 'Y', 'LastName': 'Yeshurun', 'Affiliation': 'Department of Psychology & Institute of Information Processing and Decision Making, University of Haifa, Mount Carmel, Haifa, Israel.'}]",PloS one,['10.1371/journal.pone.0231200'] 178,32315444,Adjunctive effect of mouthrinse on treatment of peri-implant mucositis using mechanical debridement: A randomized clinical trial.,"AIM To study effect of delmopinol hydrochloride (DEL) in comparison with chlorhexidine digluconate (CHX) and a placebo (PLA) in addition to non-surgical mechanical debridement in patients with peri-implant mucositis. MATERIALS AND METHODS Eighty-nine patients with at least one implant diagnosed with peri-implant mucositis were randomly assigned to one of three study groups (DEL, CHX and PLA). Professional non-surgical mechanical debridement was performed at baseline. Mouth rinsing was carried out by the patients twice a day in addition to their regular oral hygiene practices. Assessments of efficacy were performed for the primary outcome - Implant bleeding on probing (IBOP%) and secondary outcomes - modified Bleeding Index (mBI) and modified Plaque Index (mPI) at 1 and 3 months. RESULTS At 3 months, there was statistically significant reduction in IBOP% and mBI within the study groups compared to baseline. However, there was no statistically significant difference between the study groups at 3 months follow-up. Moreover, there was a statistically significant difference according to mPI at 1 month between the chlorhexidine and placebo group (p = .004). CONCLUSIONS This study confirms that mechanical debridement combined with oral hygiene instruction is effective in treatment of peri-implant mucositis. The clinical effects between groups were comparable.",2020,This study confirms that mechanical debridement combined with oral hygiene instruction is effective in treatment of peri-implant mucositis.,"['Eighty-nine patients with at least one implant diagnosed with peri-implant mucositis', 'patients with peri-implant mucositis']","['mechanical debridement combined with oral hygiene instruction', 'mouthrinse', 'mechanical debridement', 'placebo', 'delmopinol hydrochloride (DEL', 'chlorhexidine', 'placebo (PLA', 'chlorhexidine digluconate (CHX']","['Implant bleeding on probing sites (IBOP%) and secondary outcomes the modified Bleeding Index (mBI), modified Plaque Index (mPI', 'IBOP% and mBI', 'peri-implant mucositis']","[{'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C3698407', 'cui_str': 'Peri-implant mucositis'}]","[{'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0011079', 'cui_str': 'Debridement'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0204131', 'cui_str': 'Oral hygiene education'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0166532', 'cui_str': 'delmopinol'}, {'cui': 'C0008196', 'cui_str': 'Chlorhexidine'}, {'cui': 'C0055361', 'cui_str': 'Chlorhexidine gluconate'}]","[{'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0449996', 'cui_str': 'Probe location'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0011390', 'cui_str': 'Dental Plaque Indices'}, {'cui': 'C3698407', 'cui_str': 'Peri-implant mucositis'}]",89.0,0.0295568,This study confirms that mechanical debridement combined with oral hygiene instruction is effective in treatment of peri-implant mucositis.,"[{'ForeName': 'Juliana', 'Initials': 'J', 'LastName': 'Philip', 'Affiliation': 'Department of Oral Implantology and Prosthetic Dentistry, Academic Center for Dentistry Amsterdam (ACTA), University of Amsterdam and Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Marja L', 'Initials': 'ML', 'LastName': 'Laine', 'Affiliation': 'Department of Periodontology, Academic Center for Dentistry Amsterdam (ACTA), University of Amsterdam and Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Daniël', 'Initials': 'D', 'LastName': 'Wismeijer', 'Affiliation': 'Department of Oral Implantology and Prosthetic Dentistry, Academic Center for Dentistry Amsterdam (ACTA), University of Amsterdam and Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}]",Journal of clinical periodontology,['10.1111/jcpe.13295'] 179,32310620,Efficacy and safety of linaclotide for opioid-induced constipation in patients with chronic noncancer pain syndromes from a phase 2 randomized study.,"Constipation is the most common adverse event (AE) of opioid therapy. This multicenter, phase 2 study evaluated the efficacy and safety of linaclotide in treating opioid-induced constipation (OIC) in patients with chronic noncancer pain syndromes (NCT02270983). Adults with OIC (<3 spontaneous bowel movements [SBMs]/week) related to chronic noncancer pain were randomized 1:1:1 to receive linaclotide 145 µg, linaclotide 290 µg, or placebo once daily for 8 weeks. The primary endpoint was change from baseline in 8-week SBM frequency rate (SBMs/week). Secondary efficacy endpoints included 6/8-week SBM 3 + 1 responders, time to first SBM, and changes from baseline in 8-week stool consistency, abdominal bloating, and straining. Additional endpoints included treatment satisfaction and adequate relief responders. In total, 254 patients were randomized: 87, 88, and 79 received linaclotide 145 µg, linaclotide 290 µg, and placebo, respectively. The mean changes from baseline in SBMs/week during the treatment period were 2.9 and 3.5 in the linaclotide 145 and 290 µg groups (P < 0.01 for both doses), respectively, vs 1.6 in the placebo group. Diarrhea, the most common AE, was generally mild, resulting in 1.1%, 5.7%, and 1.3% of patients discontinuing in the linaclotide 145 μg, linaclotide 290 μg, and placebo groups, respectively. No serious AEs related to diarrhea were reported in any treatment group. Compared with placebo, linaclotide-treated patients had significant improvements in stool consistency, straining, abdominal bloating, and treatment satisfaction scores (P < 0.05). Linaclotide significantly improved OIC symptoms and was well tolerated in patients with chronic noncancer pain.",2020,"Compared with placebo, linaclotide-treated patients had significant improvements in stool consistency, straining, abdominal bloating, and treatment satisfaction scores (P < 0.05).","['254 patients were randomized: 87, 88, and 79 received', 'patients with chronic noncancer pain syndromes (NCT02270983', 'patients with chronic noncancer pain', 'Adults with OIC (<3 spontaneous bowel movements [SBMs]/week) related to chronic noncancer pain', 'patients with chronic noncancer pain syndromes']","['placebo', 'linaclotide 145 µg, linaclotide 290 µg, or placebo', 'opioid-induced constipation', 'linaclotide 145 µg, linaclotide 290 µg, and placebo', 'linaclotide', 'Linaclotide']","['diarrhea', 'constipation (OIC', 'Efficacy and safety', 'stool consistency, straining, abdominal bloating, and treatment satisfaction scores', 'SBM 3 + 1 responders, time to first SBM, and changes from baseline in 8-week stool consistency, abdominal bloating, and straining', 'Diarrhea', 'OIC symptoms', '8-week SBM frequency rate (SBMs/week', 'efficacy and safety', 'treatment satisfaction and adequate relief responders']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0391976', 'cui_str': 'Pain Disorder'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C2000261', 'cui_str': 'linaclotide'}, {'cui': 'C4517577', 'cui_str': '145'}, {'cui': 'C5191218', 'cui_str': '290'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}]","[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0426740', 'cui_str': 'Consistency of stool'}, {'cui': 'C0000731', 'cui_str': 'Swollen abdomen'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C3179739', 'cui_str': 'lanthanum citrate'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0564405', 'cui_str': 'Feeling relief'}]",254.0,0.186671,"Compared with placebo, linaclotide-treated patients had significant improvements in stool consistency, straining, abdominal bloating, and treatment satisfaction scores (P < 0.05).","[{'ForeName': 'Darren M', 'Initials': 'DM', 'LastName': 'Brenner', 'Affiliation': 'Department of Medicine, Division of Gastroenterology and Hepatology, Northwestern University Feinberg School of Medicine, Chicago, IL, United States.'}, {'ForeName': 'Charles E', 'Initials': 'CE', 'LastName': 'Argoff', 'Affiliation': 'Comprehensive Pain Center, Albany Medical College, Albany, NY, United States.'}, {'ForeName': 'Susan M', 'Initials': 'SM', 'LastName': 'Fox', 'Affiliation': 'Clinical Development Department, Allergan plc, Madison, NJ, United States.'}, {'ForeName': 'Wieslaw', 'Initials': 'W', 'LastName': 'Bochenek', 'Affiliation': 'Clinical Development Department, Allergan plc, Madison, NJ, United States.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'DʼAstoli', 'Affiliation': 'Clinical Development Department, Allergan plc, Madison, NJ, United States.'}, {'ForeName': 'Rick E', 'Initials': 'RE', 'LastName': 'Blakesley', 'Affiliation': 'Biostatistics Department, Allergan plc, Madison, NJ, United States. Dr. Blakesley is now with Biostatistics, Alnylam Pharmaceuticals, Cambridge, MA, United States.'}, {'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Reasner', 'Affiliation': 'Data Science Department, Ironwood Pharmaceuticals, Inc, Cambridge, MA, United States. Dr. Reasner is now with Data Science and Analytics, Imbria Pharmaceuticals, Boston, MA, United States.'}, {'ForeName': 'Christopher R', 'Initials': 'CR', 'LastName': 'OʼDea', 'Affiliation': 'Clinical Development Department, Ironwood Pharmaceuticals, Inc, Cambridge, MA, United States.'}, {'ForeName': 'Brooks D', 'Initials': 'BD', 'LastName': 'Cash', 'Affiliation': 'Ertan Digestive Disease Center, University of Texas Health Science Center, Houston, TX, United States.'}]",Pain,['10.1097/j.pain.0000000000001754'] 180,32312713,Randomized Phase IIB Trial of the Lignan Secoisolariciresinol Diglucoside in Premenopausal Women at Increased Risk for Development of Breast Cancer.,"We conducted a multiinstitutional, placebo-controlled phase IIB trial of the lignan secoisolariciresinol diglucoside (SDG) found in flaxseed. Benign breast tissue was acquired by random periareolar fine needle aspiration (RPFNA) from premenopausal women at increased risk for breast cancer. Those with hyperplasia and ≥2% Ki-67 positive cells were eligible for randomization 2:1 to 50 mg SDG/day (Brevail) versus placebo for 12 months with repeat bio-specimen acquisition. The primary endpoint was difference in change in Ki-67 between randomization groups. A total of 180 women were randomized, with 152 ultimately evaluable for the primary endpoint. Median baseline Ki-67 was 4.1% with no difference between arms. Median Ki-67 change was -1.8% in the SDG arm ( P = 0.001) and -1.2% for placebo ( P = 0.034); with no significant difference between arms. As menstrual cycle phase affects proliferation, secondary analysis was performed for 117 women who by progesterone levels were in the same phase of the menstrual cycle at baseline and off-study tissue sampling. The significant Ki-67 decrease persisted for SDG (median = -2.2%; P = 0.002) but not placebo (median = -1.0%). qRT-PCR was performed on 77 pairs of tissue specimens. Twenty-two had significant ERα gene expression changes (<0.5 or >2.0) with 7 of 10 increases in placebo and 10 of 12 decreases for SDG ( P = 0.028), and a difference between arms ( P = 0.017). Adverse event incidence was similar in both groups, with no evidence that 50 mg/day SDG is harmful. Although the proliferation biomarker analysis showed no difference between the treatment group and the placebo, the trial demonstrated use of SDG is tolerable and safe.",2020,Median Ki-67 change was -1.8% in the SDG arm (P=0.001) and -1.2% for placebo (P=0.034); with no significant difference between arms.,"['Pre-menopausal Women at Increased Risk for Development of Breast Cancer', '117 women who by progesterone levels', '180 women were randomized, with 152 ultimately evaluable for the primary endpoint', 'Those with hyperplasia and ≥2% Ki-67 positive cells']","['SDG', 'RT-qPCR', 'Lignan Secoisolariciresinol Diglucoside', 'random periareolar fine needle aspiration (RPFNA', 'lignan secoisolariciresinol diglucoside (SDG', 'placebo']","['SDG', 'change in Ki-67', 'Adverse event incidence', 'ERα gene expression changes', 'Median Ki-67 change', 'Median baseline Ki-67']","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0428409', 'cui_str': 'Progesterone level'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0020507', 'cui_str': 'Hyperplasia'}, {'cui': 'C0439178', 'cui_str': '% positive cells'}]","[{'cui': 'C0290196', 'cui_str': 'secoisolariciresinol diglucoside'}, {'cui': 'C1709846', 'cui_str': 'Real-Time PCR'}, {'cui': 'C0064971', 'cui_str': 'Lignans'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C1510483', 'cui_str': 'Fine needle aspiration biopsy - action'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0290196', 'cui_str': 'secoisolariciresinol diglucoside'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]",180.0,0.408017,Median Ki-67 change was -1.8% in the SDG arm (P=0.001) and -1.2% for placebo (P=0.034); with no significant difference between arms.,"[{'ForeName': 'Carol J', 'Initials': 'CJ', 'LastName': 'Fabian', 'Affiliation': 'Department of Internal Medicine, University of Kansas Medical Center, Kansas City, Kansas.'}, {'ForeName': 'Seema A', 'Initials': 'SA', 'LastName': 'Khan', 'Affiliation': 'Northwestern University, Chicago, Illinois.'}, {'ForeName': 'Judy E', 'Initials': 'JE', 'LastName': 'Garber', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, Massachusetts.'}, {'ForeName': 'William C', 'Initials': 'WC', 'LastName': 'Dooley', 'Affiliation': 'University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma.'}, {'ForeName': 'Lisa D', 'Initials': 'LD', 'LastName': 'Yee', 'Affiliation': 'Ohio State University, Columbus, Ohio.'}, {'ForeName': 'Jennifer R', 'Initials': 'JR', 'LastName': 'Klemp', 'Affiliation': 'Department of Internal Medicine, University of Kansas Medical Center, Kansas City, Kansas.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Nydegger', 'Affiliation': 'Department of Internal Medicine, University of Kansas Medical Center, Kansas City, Kansas.'}, {'ForeName': 'Kandy R', 'Initials': 'KR', 'LastName': 'Powers', 'Affiliation': 'Department of Internal Medicine, University of Kansas Medical Center, Kansas City, Kansas.'}, {'ForeName': 'Amy L', 'Initials': 'AL', 'LastName': 'Kreutzjans', 'Affiliation': 'Department of Internal Medicine, University of Kansas Medical Center, Kansas City, Kansas.'}, {'ForeName': 'Carola M', 'Initials': 'CM', 'LastName': 'Zalles', 'Affiliation': 'Department of Pathology, Boca Raton Hospital, Boca Raton, Florida.'}, {'ForeName': 'Trina', 'Initials': 'T', 'LastName': 'Metheny', 'Affiliation': 'Department of Internal Medicine, University of Kansas Medical Center, Kansas City, Kansas.'}, {'ForeName': 'Teresa A', 'Initials': 'TA', 'LastName': 'Phillips', 'Affiliation': 'Department of Internal Medicine, University of Kansas Medical Center, Kansas City, Kansas.'}, {'ForeName': 'Jinxiang', 'Initials': 'J', 'LastName': 'Hu', 'Affiliation': 'Department of Biostatistics & Data Science, University of Kansas Medical Center, Kansas City, Kansas.'}, {'ForeName': 'Devin C', 'Initials': 'DC', 'LastName': 'Koestler', 'Affiliation': 'Department of Biostatistics & Data Science, University of Kansas Medical Center, Kansas City, Kansas.'}, {'ForeName': 'Prabhakar', 'Initials': 'P', 'LastName': 'Chalise', 'Affiliation': 'Department of Biostatistics & Data Science, University of Kansas Medical Center, Kansas City, Kansas.'}, {'ForeName': 'Nanda Kumar', 'Initials': 'NK', 'LastName': 'Yellapu', 'Affiliation': 'Department of Biostatistics & Data Science, University of Kansas Medical Center, Kansas City, Kansas.'}, {'ForeName': 'Cheryl', 'Initials': 'C', 'LastName': 'Jernigan', 'Affiliation': 'University of Kansas Cancer Center, University of Kansas Medical Center, Kansas City, Kansas.'}, {'ForeName': 'Brian K', 'Initials': 'BK', 'LastName': 'Petroff', 'Affiliation': 'Veterinary Diagnostic Laboratory, Michigan State University, Lansing, Michigan.'}, {'ForeName': 'Stephen D', 'Initials': 'SD', 'LastName': 'Hursting', 'Affiliation': 'Department of Nutrition, University of North Carolina, Chapel Hill, North Carolina.'}, {'ForeName': 'Bruce F', 'Initials': 'BF', 'LastName': 'Kimler', 'Affiliation': 'Department of Radiation Oncology, University of Kansas Medical Center, Kansas City, Kansas. bkimler@kumc.edu.'}]","Cancer prevention research (Philadelphia, Pa.)",['10.1158/1940-6207.CAPR-20-0050'] 181,32312759,Serum Metabolomic Response to Low- and High-Dose Vitamin E Supplementation in Two Randomized Controlled Trials.,"BACKGROUND Vitamin E is an essential micronutrient and critical human antioxidant previously tested for cancer preventative effects with conflicting clinical trial results that have yet to be explained biologically. METHODS We examined baseline and on-trial serum samples for 154 men randomly assigned to receive 400 IU vitamin E (as alpha-tocopheryl acetate; ATA) or placebo daily in the Vitamin E Atherosclerosis Prevention Study (VEAPS), and for 100 men administered 50 IU ATA or placebo daily in the Alpha-Tocopherol, Beta-Carotene Cancer Prevention Study (ATBC). Over 970 metabolites were identified using ultrahigh-performance LC/MS-MS. Linear regression models estimated the change in serum metabolites of men supplemented with vitamin E versus those receiving placebo in VEAPS as compared with ATBC. RESULTS Serum alpha-carboxyethyl hydrochroman (CEHC) sulfate, alpha-tocopherol, and beta/gamma-tocopherol were significantly altered by ATA supplementation in both trials (all P values ≤5.1 × 10 -5 , the Bonferroni multiple comparisons corrected statistical threshold). Serum C 22 lactone sulfate was significantly decreased in response to the high-dose vitamin E in VEAPS (β = -0.70, P = 8.1 × 10 -6 ), but not altered by the low dose in ATBC (β = -0.17, P = 0.4). In addition, changes in androgenic steroid metabolites were strongly correlated with the vitamin E supplement-associated change in C 22 lactone sulfate only in the VEAPS trial. CONCLUSIONS We found evidence of a dose-dependent vitamin E supplementation effect on a novel C 22 lactone sulfate compound that was correlated with several androgenic steroids. IMPACT Our data add information on a differential hormonal response based on vitamin E dose that could have direct relevance to opposing prostate cancer incidence results from previous large controlled trials.",2020,"Serum C22 lactone sulfate was significantly decreased in response to the high-dose vitamin E in VEAPS (β=-0.70, p-value=8.1×10-6) but not altered by the low-dose in ATBC (","['100 men administered', '154 men randomly assigned to receive']","['placebo', '50 IU ATA or placebo', '400 IU vitamin E (as alpha-tocopheryl acetate; ATA) or placebo', 'Low- and High-Dose Vitamin E Supplementation', 'vitamin E']","['Serum Metabolomic Response', 'Serum C22 lactone sulfate', 'Serum alpha-carboxyethyl hydrochroman (CEHC) sulfate, alpha-tocopherol, and beta-/gamma-tocopherol', 'androgenic steroid metabolites', 'C22 lactone sulfate']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C5191279', 'cui_str': '154'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0002602', 'cui_str': 'Aminotriazole'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0042874', 'cui_str': 'Vitamin E'}, {'cui': 'C1999896', 'cui_str': 'Alpha tocopherol acetate'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C4524012', 'cui_str': 'Vitamin E supplementation'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C1328813', 'cui_str': 'Metabolomics'}, {'cui': 'C0754985', 'cui_str': ""N,N'-ethylenebis(benzohydroxamamide)""}, {'cui': 'C0022947', 'cui_str': 'Lactone'}, {'cui': 'C0038720', 'cui_str': 'Inorganic sulfate'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0969677', 'cui_str': 'alpha Tocopherol'}, {'cui': 'C0330390', 'cui_str': 'Beta'}, {'cui': 'C0042874', 'cui_str': 'Vitamin E'}, {'cui': 'C0038317', 'cui_str': 'Steroid'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}]",970.0,0.292577,"Serum C22 lactone sulfate was significantly decreased in response to the high-dose vitamin E in VEAPS (β=-0.70, p-value=8.1×10-6) but not altered by the low-dose in ATBC (","[{'ForeName': 'Jiaqi', 'Initials': 'J', 'LastName': 'Huang', 'Affiliation': 'Division of Cancer Epidemiology and Genetics, National Cancer Institute, National Institutes of Health, Rockville, Maryland. jiaqi.huang@nih.gov daa@nih.gov.'}, {'ForeName': 'Howard N', 'Initials': 'HN', 'LastName': 'Hodis', 'Affiliation': 'Atherosclerosis Research Unit, Department of Preventive Medicine, Keck School of Medicine, University of Southern California (USC), Los Angeles, California.'}, {'ForeName': 'Stephanie J', 'Initials': 'SJ', 'LastName': 'Weinstein', 'Affiliation': 'Division of Cancer Epidemiology and Genetics, National Cancer Institute, National Institutes of Health, Rockville, Maryland.'}, {'ForeName': 'Wendy J', 'Initials': 'WJ', 'LastName': 'Mack', 'Affiliation': 'Atherosclerosis Research Unit, Department of Preventive Medicine, Keck School of Medicine, University of Southern California (USC), Los Angeles, California.'}, {'ForeName': 'Joshua N', 'Initials': 'JN', 'LastName': 'Sampson', 'Affiliation': 'Division of Cancer Epidemiology and Genetics, National Cancer Institute, National Institutes of Health, Rockville, Maryland.'}, {'ForeName': 'Alison M', 'Initials': 'AM', 'LastName': 'Mondul', 'Affiliation': 'Department of Epidemiology, University of Michigan School of Public Health, Ann Arbor, Michigan.'}, {'ForeName': 'Demetrius', 'Initials': 'D', 'LastName': 'Albanes', 'Affiliation': 'Division of Cancer Epidemiology and Genetics, National Cancer Institute, National Institutes of Health, Rockville, Maryland. jiaqi.huang@nih.gov daa@nih.gov.'}]","Cancer epidemiology, biomarkers & prevention : a publication of the American Association for Cancer Research, cosponsored by the American Society of Preventive Oncology",['10.1158/1055-9965.EPI-20-0187'] 182,31944276,"Efficacy and safety of adjunctive perampanel 4 mg/d for the treatment of focal seizures: A pooled post hoc analysis of four randomized, double-blind, phase III studies.","OBJECTIVE This post hoc analysis evaluated the efficacy and safety of adjunctive perampanel 4 mg/d received as modal dose, which may have differed from randomized dose, for treatment of focal seizures. METHODS Data were pooled from four randomized, double-blind, placebo-controlled, phase III studies of adjunctive perampanel in patients (aged ≥12 years) with focal seizures, with/without focal to bilateral tonic-clonic (FBTC) seizures: studies 304 (NCT00699972), 305 (NCT00699582), 306 (NCT00700310), and 335 (NCT01618695). Efficacy assessments included median percentage reductions in seizure frequency per 28 days and seizure-freedom rates for patients receiving placebo and perampanel 4 mg/d (modal dose). Treatment-emergent adverse events (TEAEs) were assessed in patients receiving perampanel 4 mg/d at their TEAE onset. Outcomes were also assessed with/without enzyme-inducing antiseizure medications (EIASMs). RESULTS The full analysis set included 979 patients with focal seizures (placebo: n = 616 [235 with FBTC seizures]; perampanel 4 mg/d: n = 363 [134 with FBTC seizures]). Compared with placebo, perampanel 4 mg/d conferred significantly greater median percentage reductions in seizure frequency per 28 days for focal (12.6% vs 21.1%; P = .0004) and FBTC seizures (17.4% vs 49.8%; P < .0001), and seizure-freedom rates for focal (0.8% vs 3.6%; P = .0018) and FBTC seizures (11.1% vs 18.7%; P = .0424). Seizure improvements with perampanel 4 mg/d were greater without EIASMs than with EIASMs. For assessment of TEAEs, overall 1376 patients with focal seizures received perampanel 4 mg/d at any time (FBTC seizures, n = 499). TEAEs with perampanel 4 mg/d occurred in 419 of 1376 (30.5%) and 148 of 499 (29.7%) patients with focal and FBTC seizures, respectively; most common was dizziness. The proportion of TEAEs was similar with or without EIASMs. SIGNIFICANCE This post hoc analysis showed adjunctive perampanel 4 mg/d was efficacious and well tolerated in patients with focal seizures, with or without FBTC seizures. This dose may be a valuable treatment option in patients unable to tolerate higher perampanel doses up to 12 mg/d.",2020,"Compared with placebo, perampanel 4 mg/d conferred significantly greater median percentage reductions in seizure frequency per 28 days for focal (12.6% vs 21.1%; P = .0004) and FBTC seizures (17.4% vs 49.8%; P < .0001), and seizure-freedom rates for focal (0.8% vs 3.6%; P = .0018) and FBTC seizures (11.1% vs 18.7%; P = .0424).","['patients with focal seizures, with or without FBTC seizures', '979 patients with focal seizures (placebo: n\xa0=\xa0616 [235 with FBTC seizures', '1376 patients with focal seizures', 'focal seizures', 'in patients (aged\xa0≥12\xa0years) with focal seizures, with/without focal to bilateral tonic-clonic (FBTC) seizures', 'd: n\xa0=\xa0363']","['placebo', 'perampanel 4\xa0mg', 'perampanel', 'placebo, perampanel', 'adjunctive perampanel']","['efficacious and well tolerated', 'FBTC seizures', 'efficacy and safety', 'Efficacy and safety', 'seizure frequency per 28\xa0days and seizure-freedom rates', 'dizziness', 'antiseizure medications (EIASMs', 'seizure frequency', 'seizure-freedom rates for focal']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0751495', 'cui_str': 'Seizures, Focal'}, {'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205234', 'cui_str': 'Focal (qualifier value)'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0494475', 'cui_str': 'Generalized Tonic-Clonic Seizures'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3504770', 'cui_str': 'perampanel 4 MG [FYCOMPA]'}, {'cui': 'C2698764', 'cui_str': 'perampanel'}]","[{'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0205234', 'cui_str': 'Focal (qualifier value)'}]",979.0,0.632538,"Compared with placebo, perampanel 4 mg/d conferred significantly greater median percentage reductions in seizure frequency per 28 days for focal (12.6% vs 21.1%; P = .0004) and FBTC seizures (17.4% vs 49.8%; P < .0001), and seizure-freedom rates for focal (0.8% vs 3.6%; P = .0018) and FBTC seizures (11.1% vs 18.7%; P = .0424).","[{'ForeName': 'Bernhard J', 'Initials': 'BJ', 'LastName': 'Steinhoff', 'Affiliation': 'Kork Epilepsy Center, Kehl-Kork, Germany.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Patten', 'Affiliation': 'Eisai Ltd, Hatfield, UK.'}, {'ForeName': 'Betsy', 'Initials': 'B', 'LastName': 'Williams', 'Affiliation': 'Formerly with Eisai Inc, Woodcliff Lake, New Jersey.'}, {'ForeName': 'Manoj', 'Initials': 'M', 'LastName': 'Malhotra', 'Affiliation': 'Eisai Inc, Woodcliff Lake, New Jersey.'}]",Epilepsia,['10.1111/epi.16428'] 183,31846501,"Implementation of a Cost-Effective Physical Therapy Approach (Coach2Move) to Improve Physical Activity in Community-Dwelling Older Adults With Mobility Problems: Protocol for a Cluster-Randomized, Stepped Wedge Trial.","BACKGROUND Coach2Move is a personalized treatment strategy by physical therapists to elicit physical activity in community-dwelling older adults with mobility problems. OBJECTIVE The primary objective of this study is to assess the effectiveness and cost-effectiveness of the implementation of Coach2Move compared with regular care physical therapy in daily clinical practice. DESIGN, SETTING, PARTICIPANTS, AND INTERVENTION A multicenter cluster-randomized stepped wedge trial is being implemented in 16 physical therapist practices (4 clusters of 4 practices in 4 steps) in the Netherlands. The study aims to include 400 older adults (≥70 years) living independently with mobility problems and/or physically inactive lifestyles. The intervention group receives physical therapy conforming to the Coach2Move strategy; the usual care group receives typical physical therapist care. MEASUREMENTS Measurements are taken at baseline and 3, 6, and 12 months after the start of treatment. The primary outcomes for effectiveness are the amount of physical activity (LASA Physical Activity Questionnaire) and functional mobility (Timed Up and Go test). Trial success can be declared if at least 1 parameter improves while another does not deteriorate. Secondary outcomes are level of frailty (Evaluative Frailty Index for Physical Activity), perceived effect (Global Perceived Effect and Patient Specific Complaints questionnaire), quality of life (EQ-5D-5 L), and health care expenditures. Multilevel linear regression analyses are used to compare the outcomes between treatment groups according to an intention-to-treat approach. Alongside the trial, a mixed-methods process evaluation is performed to understand the outcomes, evaluate therapist fidelity to the strategy, and detect barriers and facilitators in implementation. LIMITATIONS An important limitation of the study design is the inability to blind treating therapists to study allocation. DISCUSSION The trial provides insight into the effectiveness and cost-effectiveness of the Coach2Move strategy compared with usual care. The process evaluation provides insight into influencing factors related to outcomes and implementation.",2020,The primary outcomes for effectiveness are the amount of physical activity (LASA Physical Activity Questionnaire) and functional mobility (Timed Up and Go test).,"['Community-Dwelling Older Adults With Mobility Problems', '16 physical therapy practices (4 clusters of 4 practices in 4 steps) in the Netherlands', 'community-dwelling older adults with mobility problems', '400 older adults (≥70\xa0years), living independently with mobility problems and/or physically inactive lifestyles']","['physical therapy conforming to the Coach2Move strategy; the usual care group receives typical physical therapy care', 'regular care physical therapy', 'Cost-Effective Physical Therapy Approach (Coach2Move']","['effectiveness and cost-effectiveness', 'amount of physical activity (LASA Physical Activity Questionnaire) and functional mobility (Timed Up and Go test', 'level of frailty (Evaluative Frailty Index for Physical Activity), perceived effect (Global Perceived Effect and Patient Specific Complaints questionnaire), quality of life (EQ-5D-5\xa0L), and healthcare expenditures', 'Physical Activity']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}]","[{'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205272', 'cui_str': 'Regular (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0065034', 'cui_str': 'lipid-associated sialic acid'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C4075886', 'cui_str': 'Frailty Index'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0277786', 'cui_str': 'Presenting complaint'}, {'cui': 'C0034380'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C0015316', 'cui_str': 'Expenditures'}]",400.0,0.098777,The primary outcomes for effectiveness are the amount of physical activity (LASA Physical Activity Questionnaire) and functional mobility (Timed Up and Go test).,"[{'ForeName': 'Ward', 'Initials': 'W', 'LastName': 'Heij', 'Affiliation': 'Radboud university medical center, Radboud Institute for Health Sciences, IQ healthcare, PO Box 9101, 6500 HB, Nijmegen, the Netherlands.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Teerenstra', 'Affiliation': 'Radboud university medical center, Radboud Institute for Health Sciences, Department of Health Evidence, Section Biostatistics.'}, {'ForeName': 'Lieke', 'Initials': 'L', 'LastName': 'Sweerts', 'Affiliation': 'Radboud university medical center, Radboud Institute for Health Sciences, IQ healthcare; Radboud university medical center, Radboud Institute for Health Sciences, Department of Orthopaedics.'}, {'ForeName': 'J Bart', 'Initials': 'JB', 'LastName': 'Staal', 'Affiliation': 'Radboud university medical center, Radboud Institute for Health Sciences, IQ healthcare; and HAN University of Applied Sciences, Research Group Musculoskeletal Rehabilitation, Nijmegen, the Netherlands.'}, {'ForeName': 'Maria W G', 'Initials': 'MWG', 'LastName': 'Nijhuis-van der Sanden', 'Affiliation': 'Radboud university medical center, Radboud Institute for Health Sciences, IQ healthcare.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Hoogeboom', 'Affiliation': 'Radboud university medical center, Radboud Institute for Health Sciences, IQ healthcare.'}]",Physical therapy,['10.1093/ptj/pzz183'] 184,31732234,Lung Ultrasound-Guided Dry Weight Assessment and Echocardiographic Measures in Hypertensive Hemodialysis Patients: A Randomized Controlled Study.,"RATIONALE & OBJECTIVE Left ventricular (LV) hypertrophy and dysfunction are associated with adverse outcomes in hemodialysis patients. Hypertension and hypervolemia play important roles in these cardiac abnormalities. We report on the prespecified secondary outcome, echocardiographic indexes of LV function, from a previously reported study of the effect of lung ultrasound (US)-guided dry weight reduction on systolic blood pressure. STUDY DESIGN Single-blind randomized trial. SETTINGS & PARTICIPANTS 71 clinically euvolemic hypertensive hemodialysis patients in Greece and Slovenia. INTERVENTION The active intervention group's (n=35) volume removal was guided by the total number of lung US B-lines observed every week before a midweek dialysis session. The usual-care group (n=36) was treated using standard-of-care processes that did not include acquisition of US data. OUTCOMES 2-dimensional and tissue Doppler echocardiographic indexes at baseline and study end (8 weeks) that evaluated left and right heart chamber sizes, as well as systolic and diastolic function. RESULTS Overall, 19 (54%) patients in the active intervention and 5 (14%) in the usual-care group had ultrafiltration intensification (P<0.001) during follow-up; changes in US B-lines (-5.3±12.5 vs+2.2±7.6; P<0.001) and dry weight (-0.71±1.39 vs+0.51±0.98kg; P<0.001) significantly differed between the active and usual-care groups. Inferior vena cava diameter decreased in the active compared with the usual-care group (-0.43±4.00 vs 0.71±4.82cm; P=0.03) at study end. Left (LA) and right (RA) atrial dimensions decreased more in the active group (LA surface, -1.09±4.61 vs 0.93±3.06cm 2 ; P=0.03; RA surface -1.56±6.17 vs 0.47±2.31; P=0.02). LA volume index nominally decreased more in the active group (-2.43±13.14 vs 2.95±9.42mL/m 2 ), though this was of borderline statistical significance (P=0.05). Reductions in LV end-diastolic diameter and volume were marginally greater in the active group. The change in LV filling pressures was significantly different in the active compared with the usual-care group (early transmitral diastolic velocities ratio [E/e'], -0.38±3.14 vs 1.36±3.54; P=0.03; E wave deceleration time, 35.43±85.25 vs-18.44±50.69; P=0.002]. Systolic function indexes were unchanged in both groups. In multivariable analysis, US B-line reduction was associated with a reduction in the E/e' LV ratio (OR, 4.542; 95% CI, 1.266-16.292; P=0.02). LIMITATIONS Exploratory study; small sample size. CONCLUSIONS A US-guided strategy for dry weight reduction is associated with decreased cardiac chamber dimensions and LV filling pressure, but no difference in systolic performance compared with usual care in hypertensive hemodialysis patients. FUNDING European Renal Association-European Dialysis and Transplant Association. TRIAL REGISTRATION Registered at ClinicalTrials.gov with study number NCT03058874.",2020,"Left (LA) and right (RA) atrial dimensions decreased more in the active group (LA surface, -1.09±4.61 vs 0.93±3.06cm 2 ; P=0.03; RA surface -1.56±6.17 vs 0.47±2.31; P=0.02).","['hemodialysis patients', '71 clinically euvolemic hypertensive hemodialysis patients in Greece and Slovenia', 'hypertensive hemodialysis patients', 'Hypertensive Hemodialysis Patients']","['Lung Ultrasound-Guided Dry Weight Assessment and Echocardiographic Measures', 'lung ultrasound (US)-guided dry weight reduction']","['ultrafiltration intensification', 'systolic performance', 'LA volume index', 'cardiac chamber dimensions and LV filling pressure', 'dry weight', 'evaluated left and right heart chamber sizes, as well as systolic and diastolic function', 'Systolic function indexes', '2-dimensional and tissue Doppler echocardiographic indexes', 'change in LV filling\xa0pressures', 'Reductions in LV\xa0end-diastolic diameter and volume', 'Inferior vena cava diameter', 'systolic blood pressure', 'Left (LA) and right (RA) atrial dimensions']","[{'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0018226', 'cui_str': 'Greece'}, {'cui': 'C0037334', 'cui_str': 'Slovenia'}]","[{'cui': 'C4286019', 'cui_str': 'Lung ultrasound'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C2709005', 'cui_str': 'Dry body weight (observable entity)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}]","[{'cui': 'C0041612', 'cui_str': 'Ultrafiltration'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0729936', 'cui_str': 'Intracardiac (qualifier value)'}, {'cui': 'C0439534', 'cui_str': 'Dimensions (qualifier value)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C2709005', 'cui_str': 'Dry body weight (observable entity)'}, {'cui': 'C0205090', 'cui_str': 'Right (qualifier value)'}, {'cui': 'C0018787', 'cui_str': 'Heart'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C1301886', 'cui_str': 'Diameter (qualifier value)'}, {'cui': 'C0042458', 'cui_str': 'Vena Cava, Inferior'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}]",71.0,0.0828408,"Left (LA) and right (RA) atrial dimensions decreased more in the active group (LA surface, -1.09±4.61 vs 0.93±3.06cm 2 ; P=0.03; RA surface -1.56±6.17 vs 0.47±2.31; P=0.02).","[{'ForeName': 'Charalampos', 'Initials': 'C', 'LastName': 'Loutradis', 'Affiliation': 'Department of Nephrology, Hippokration Hospital, Aristotle University of Thessaloniki, Thessaloniki, Greece.'}, {'ForeName': 'Christodoulos E', 'Initials': 'CE', 'LastName': 'Papadopoulos', 'Affiliation': 'Third Department of Cardiology, Hippokration Hospital, Aristotle University of Thessaloniki, Thessaloniki, Greece.'}, {'ForeName': 'Vassilios', 'Initials': 'V', 'LastName': 'Sachpekidis', 'Affiliation': 'Department of Cardiology, Papageorgiou Hospital, Thessaloniki, Greece.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Ekart', 'Affiliation': 'Department of Dialysis, University Clinical Centre Maribor, Clinic for Internal Medicine, Maribor, Slovenia.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Krunic', 'Affiliation': 'Department of Cardiology, University Clinical Centre Maribor, Clinic for Internal Medicine, Maribor, Slovenia.'}, {'ForeName': 'Antonios', 'Initials': 'A', 'LastName': 'Karpetas', 'Affiliation': 'Department of Nephrology, Hippokration Hospital, Aristotle University of Thessaloniki, Thessaloniki, Greece; Therapeutiki Hemodialysis Unit, Thessaloniki, Greece.'}, {'ForeName': 'Athanasios', 'Initials': 'A', 'LastName': 'Bikos', 'Affiliation': 'Department of Nephrology, Hippokration Hospital, Aristotle University of Thessaloniki, Thessaloniki, Greece; Protypo Hemodialysis Unit, Thessaloniki, Greece.'}, {'ForeName': 'Ioannis', 'Initials': 'I', 'LastName': 'Tsouchnikas', 'Affiliation': 'Department of Nephrology, Hippokration Hospital, Aristotle University of Thessaloniki, Thessaloniki, Greece.'}, {'ForeName': 'Efstathios', 'Initials': 'E', 'LastName': 'Mitsopoulos', 'Affiliation': 'Department of Nephrology, Papageorgiou Hospital, Thessaloniki, Greece.'}, {'ForeName': 'Aikaterini', 'Initials': 'A', 'LastName': 'Papagianni', 'Affiliation': 'Department of Nephrology, Hippokration Hospital, Aristotle University of Thessaloniki, Thessaloniki, Greece.'}, {'ForeName': 'Carmine', 'Initials': 'C', 'LastName': 'Zoccali', 'Affiliation': 'CNR-IFC Clinical Epidemiology of Renal Diseases and Hypertension, Reggio Calabria, Italy.'}, {'ForeName': 'Pantelis', 'Initials': 'P', 'LastName': 'Sarafidis', 'Affiliation': 'Department of Nephrology, Hippokration Hospital, Aristotle University of Thessaloniki, Thessaloniki, Greece. Electronic address: psarafidis11@yahoo.gr.'}]",American journal of kidney diseases : the official journal of the National Kidney Foundation,['10.1053/j.ajkd.2019.07.025'] 185,31160146,Neuroimaging findings from an experimental pharmacology trial of naltrexone in heavy drinkers of East Asian descent.,"BACKGROUND Despite known genetic variation across races, studies examining pharmacogenetics of a single nucleotide polymorphism (SNP) of the mu-opioid receptor gene (OPRM1) on clinical response to naltrexone have been conducted in predominantly Caucasian samples. Evidence is mixed for pharmacogenetic OPRM1 and naltrexone effects on neural responses to alcohol cues. The current study tests the pharmacogenetic effects of naltrexone and OPRM1 on neural responses to alcohol taste cues in heavy drinkers of East Asian descent. METHODS Participants (N = 41) completed two double-blinded and counterbalanced functional magnetic resonance imaging (fMRI) sessions: one after taking naltrexone (50 mg/day) for four days and one after taking placebo for four days. Following titration, participants completed an fMRI alcohol taste-cues task. Analyses tested effects of naltrexone, OPRM1, and their interaction in whole-brain and region of interest (ROI) analyses of functional activation and functional connectivity in response to alcohol versus water taste cues. RESULTS We found no effects of naltrexone orOPRM1 on neural activation in whole-brain and ROI analyses, which included left and right ventral striatum (VS), anterior cingulate cortex (ACC), and orbitofrontal cortex (OFC). Naltrexone increased functional connectivity between left VS and clusters in medial prefrontal cortex, posterior cingulate gyrus, as well as right VS and occipital cortex, compared to placebo. CONCLUSIONS Naltrexone treatment enhanced functional connectivity in a key reinforcement-related pathway during alcohol versus water taste cues, corroborating neuroimaging work with other substances. Null medication and pharmacogenetics effects on functional activation add to a mixed naltrexone literature and may underscore the modest size of these effects in East Asians.",2019,"We found no effects of naltrexone orOPRM1 on neural activation in whole-brain and ROI analyses, which included left and right ventral striatum (VS), anterior cingulate cortex (ACC), and orbitofrontal cortex (OFC).","['East Asians', 'heavy drinkers of East Asian descent', 'Participants (N\u2009=\u200941']","['counterbalanced functional magnetic resonance imaging (fMRI) sessions: one after taking naltrexone', 'placebo', 'fMRI alcohol taste-cues task', 'naltrexone, OPRM1', 'naltrexone', 'naltrexone orOPRM1', 'Naltrexone', 'naltrexone and OPRM1']","['left and right ventral striatum (VS), anterior cingulate cortex (ACC), and orbitofrontal cortex (OFC', 'functional connectivity']","[{'cui': 'C0337678', 'cui_str': 'Heavy drinker (finding)'}, {'cui': 'C0078988', 'cui_str': 'Asians'}]","[{'cui': 'C0376335', 'cui_str': 'fMRI'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0027360', 'cui_str': 'Naltrexone'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0039336', 'cui_str': 'Gustation'}, {'cui': 'C0010439', 'cui_str': 'Cues'}]","[{'cui': 'C0205090', 'cui_str': 'Right (qualifier value)'}, {'cui': 'C0750950', 'cui_str': 'Ventral Striatum'}, {'cui': 'C0175190', 'cui_str': 'Anterior Cingulate'}, {'cui': 'C2331062', 'cui_str': 'Orbital Area'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}]",,0.0705927,"We found no effects of naltrexone orOPRM1 on neural activation in whole-brain and ROI analyses, which included left and right ventral striatum (VS), anterior cingulate cortex (ACC), and orbitofrontal cortex (OFC).","[{'ForeName': 'Aaron C', 'Initials': 'AC', 'LastName': 'Lim', 'Affiliation': 'Department of Psychology, University of California, Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Dara G', 'Initials': 'DG', 'LastName': 'Ghahremani', 'Affiliation': 'Department of Psychiatry and Biobehavioral Sciences, University of California, Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Erica N', 'Initials': 'EN', 'LastName': 'Grodin', 'Affiliation': 'Department of Psychology, University of California, Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'ReJoyce', 'Initials': 'R', 'LastName': 'Green', 'Affiliation': 'Department of Psychology, University of California, Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Spencer', 'Initials': 'S', 'LastName': 'Bujarski', 'Affiliation': 'Department of Psychology, University of California, Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Emily E', 'Initials': 'EE', 'LastName': 'Hartwell', 'Affiliation': 'Department of Psychology, University of California, Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Kelly E', 'Initials': 'KE', 'LastName': 'Courtney', 'Affiliation': 'Department of Psychology, University of California, San Diego, San Diego, CA, USA.'}, {'ForeName': 'Kent', 'Initials': 'K', 'LastName': 'Hutchison', 'Affiliation': 'Department of Psychology, University of Colorado, Boulder, CO, USA.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Miotto', 'Affiliation': 'Department of Psychiatry and Biobehavioral Sciences, University of California, Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Lara A', 'Initials': 'LA', 'LastName': 'Ray', 'Affiliation': 'Department of Psychology, University of California, Los Angeles, Los Angeles, CA, USA; Department of Psychiatry and Biobehavioral Sciences, University of California, Los Angeles, Los Angeles, CA, USA. Electronic address: lararay@psych.ucla.edu.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2019.02.028'] 186,31504090,Acute Effect of Eating Sweets on Alcohol Cravings in a Sample with At-Risk Drinking.,"BACKGROUND Alcohol craving, or the desire to drink alcohol, has been identified as a key experience preceding alcohol use. Alcoholics Anonymous has long claimed that individuals can allay alcohol cravings by eating sweets. Empirical tests of this strategy are limited to a few preclinical studies in rats, and there is no existing experiment testing the acute effect of eating sweets on alcohol cravings in humans. PURPOSE The current study sought to experimentally test the acute effect of eating sweets on alcohol cravings in a sample with at-risk drinking. METHODS After being exposed to an alcohol cue, individuals with at-risk drinking (N = 150) were randomly assigned to eat sweets (n = 60), eat calorie-equivalent bland food (n = 60), or watch a video (n = 30). Caloric amounts were manipulated. Individuals with at-risk drinking were then exposed to a second alcohol cue. Changes in alcohol cravings from after the first to after the second alcohol cue were measured via visual analog scale and heart rate. RESULTS There were no significant between-group differences in changes in alcohol cravings. Caloric amounts did not modify effects. CONCLUSIONS Experimental findings did not provide evidence to support the clinical lore that eating sweets can reduce alcohol cravings, albeit only acutely and for those with at-risk drinking. Other empirically supported strategies for managing alcohol cravings (e.g., pharmacotherapies, mindfulness) could instead be promoted.",2020,There were no significant between-group differences in changes in alcohol cravings.,"['individuals with at-risk drinking (N = 150', 'a Sample with At-Risk Drinking', 'Individuals with at-risk drinking']","['Eating Sweets', 'eat calorie-equivalent bland food', 'eating sweets', 'eat sweets']","['alcohol cravings', 'visual analog scale and heart rate', 'Alcohol Cravings']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0684271', 'cui_str': 'Drinkings'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}]","[{'cui': 'C0013470', 'cui_str': 'Food Intake'}, {'cui': 'C0453447', 'cui_str': 'Sugar candy'}, {'cui': 'C1879985', 'cui_str': 'calorie'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0016452', 'cui_str': 'Food'}]","[{'cui': 'C0556385', 'cui_str': 'Craving for alcohol (finding)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}]",,0.0125672,There were no significant between-group differences in changes in alcohol cravings.,"[{'ForeName': 'Jenna R', 'Initials': 'JR', 'LastName': 'Cummings', 'Affiliation': 'Department of Psychology, University of California, Los Angeles, CA, USA.'}, {'ForeName': 'Lara A', 'Initials': 'LA', 'LastName': 'Ray', 'Affiliation': 'Department of Psychology, University of California, Los Angeles, CA, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Nooteboom', 'Affiliation': 'Department of Psychology, University of California, Los Angeles, CA, USA.'}, {'ForeName': 'A Janet', 'Initials': 'AJ', 'LastName': 'Tomiyama', 'Affiliation': 'Department of Psychology, University of California, Los Angeles, CA, USA.'}]",Annals of behavioral medicine : a publication of the Society of Behavioral Medicine,['10.1093/abm/kaz031'] 187,32233107,Patient-reported outcomes in a phase 2 study comparing atezolizumab alone or with bevacizumab vs sunitinib in previously untreated metastatic renal cell carcinoma.,"OBJECTIVE To evaluate patient-reported outcome (PRO) data from the IMmotion150 study. The phase 2 IMmotion150 study showed improved progression-free survival with atezolizumab plus bevacizumab vs sunitinib in patients with programmed death-ligand 1 (PD-L1)+ tumours and suggested activity of atezolizumab monotherapy in previously untreated metastatic renal cell carcinoma (mRCC). PATIENTS AND METHODS Patients with previously untreated mRCC were randomised to atezolizumab 1200 mg intravenously (i.v.) every 3 weeks (n = 103), the atezolizumab regimen plus bevacizumab 15 mg/kg i.v. every 3 weeks (n = 101), or sunitinib 50 mg orally daily (4 weeks on, 2 weeks off; n = 101). The MD Anderson Symptom Inventory (MDASI) and Brief Fatigue Inventory (BFI) were administered on days 1 and 22 of each 6-week cycle. Time to deterioration (TTD), change from baseline in MDASI core and RCC symptom severity, interference with daily life, and BFI fatigue severity and interference scores were reported for all comers. The TTD was the first ≥2-point score increase over baseline. Absolute effect size ≥0.2 suggested a clinically important difference with checkpoint inhibitor therapy vs sunitinib. RESULTS Completion rates were >90% at baseline and ≥80% at most visits. Delayed TTD in core and RCC symptoms, symptom interference, fatigue, and fatigue-related interference was observed with atezolizumab (both alone and in combination) vs sunitinib. Improved TTD (hazard ratio [HR], 95% confidence interval [CI]) was more pronounced with atezolizumab monotherapy: core symptoms, 0.39 (0.22-0.71); RCC symptoms, 0.22 (0.12-0.41); and symptom interference, 0.36 (0.22-0.58). Change from baseline by visit, evaluated by the MDASI, also showed a trend favouring atezolizumab monotherapy vs sunitinib. Small sample sizes may have limited the ability to draw definitive conclusions. CONCLUSION PROs suggested that atezolizumab alone or with bevacizumab maintained daily function compared with sunitinib. Notably, symptoms were least severe with atezolizumab alone vs sunitinib (IMmotion150; ClinicalTrials.gov Identifier: NCT01984242).",2020,MD Anderson Symptom Inventory (MDASI) and Brief Fatigue Inventory (BFI) were administered on days 1 and 22 of each 6-week cycle.,"['Previously Untreated Metastatic Renal Cell Carcinoma', 'patients with PD-L1+ tumours', 'Patients with previously untreated mRCC']","['bevacizumab', 'Bevacizumab Versus Sunitinib', 'Atezolizumab', 'atezolizumab alone versus sunitinib', 'atezolizumab monotherapy', 'atezolizumab plus bevacizumab', 'atezolizumab regimen plus bevacizumab', 'atezolizumab']","['progression-free survival', 'MD Anderson Symptom Inventory (MDASI) and Brief Fatigue Inventory (BFI', 'Time to deterioration (TTD), change from baseline in MDASI core and RCC symptom severity, interference with daily life, and BFI fatigue severity and interference scores', 'Delayed TTD in core and RCC symptoms, symptom interference, fatigue, and fatigue-related interference', 'Completion rates']","[{'cui': 'C0278678', 'cui_str': 'Metastatic renal cell carcinoma'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}]","[{'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C1176020', 'cui_str': 'sunitinib'}, {'cui': 'C4055433', 'cui_str': 'atezolizumab'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0444669', 'cui_str': 'Core (qualifier value)'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity (finding)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.19299,MD Anderson Symptom Inventory (MDASI) and Brief Fatigue Inventory (BFI) were administered on days 1 and 22 of each 6-week cycle.,"[{'ForeName': 'Sumanta K', 'Initials': 'SK', 'LastName': 'Pal', 'Affiliation': 'Department of Medical Oncology and Experimental Therapeutics, City of Hope Comprehensive Cancer Center, Duarte, CA, USA.'}, {'ForeName': 'David F', 'Initials': 'DF', 'LastName': 'McDermott', 'Affiliation': 'Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Michael B', 'Initials': 'MB', 'LastName': 'Atkins', 'Affiliation': 'Georgetown Lombardi Comprehensive Cancer Center, Georgetown University, Washington, DC, USA.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Escudier', 'Affiliation': 'Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Brian I', 'Initials': 'BI', 'LastName': 'Rini', 'Affiliation': 'Taussig Cancer Institute, Cleveland Clinic, Cleveland, OH, USA.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Motzer', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Fong', 'Affiliation': 'School of Medicine, University of California, San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Richard W', 'Initials': 'RW', 'LastName': 'Joseph', 'Affiliation': 'Mayo Clinic Hospital, Jacksonville, FL, USA.'}, {'ForeName': 'Stephane', 'Initials': 'S', 'LastName': 'Oudard', 'Affiliation': 'Department of Medical Oncology, Georges Pompidou Hospital, Paris Descartes University, Paris, France.'}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Ravaud', 'Affiliation': 'CHU H__pitaux de Bordeaux, Hôpital Saint-André, Bordeaux, France.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Bracarda', 'Affiliation': 'Azienda Ospedaliera S. Maria, Terni, Italy.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Suárez', 'Affiliation': ""Vall d'Hebron University Hospital and Institute of Oncology, Barcelona, Spain.""}, {'ForeName': 'Elaine T', 'Initials': 'ET', 'LastName': 'Lam', 'Affiliation': 'Anschutz Medical Campus, University of Colorado, Aurora, CO, USA.'}, {'ForeName': 'Toni K', 'Initials': 'TK', 'LastName': 'Choueiri', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, MA, USA.'}, {'ForeName': 'Beiying', 'Initials': 'B', 'LastName': 'Ding', 'Affiliation': 'Genentech, Inc., South San Francisco, CA, USA.'}, {'ForeName': 'Caroleen', 'Initials': 'C', 'LastName': 'Quach', 'Affiliation': 'Genentech, Inc., South San Francisco, CA, USA.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Hashimoto', 'Affiliation': 'Roche Products Ltd, Welwyn Garden City, UK.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Schiff', 'Affiliation': 'Genentech, Inc., South San Francisco, CA, USA.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Piault-Louis', 'Affiliation': 'Genentech, Inc., South San Francisco, CA, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Powles', 'Affiliation': 'Barts Cancer Institute, Royal Free Hospital, Queen Mary University of London, London, UK.'}]",BJU international,['10.1111/bju.15058'] 188,31944869,Exploring Input Parameters in an Expressive Vocabulary Treatment With Late Talkers.,"Purpose The aims of this study were (a) to assess the efficacy of the Vocabulary Acquisition and Usage for Late Talkers (VAULT) treatment and (b) to compare treatment outcomes for expressive vocabulary acquisition in late talkers in 2 conditions: 3 target words/90 doses per word per session versus 6 target words/45 doses per word per session. Method We ran the treatment protocol for 16 sessions with 24 primarily monolingual English-speaking late talkers. We calculated a d score for each child, compared treatment to control effect sizes, and assessed the number of words per week children acquired outside treatment. We compared treatment effect sizes of children in the condition of 3 target words/90 doses per word to those in the condition of 6 target words/45 doses per word. We used Bayesian repeated-measures analysis of variance and Bayesian t tests to answer our condition-level questions. Results With an average treatment effect size of almost 1.0, VAULT was effective relative to the no-treatment condition. There were no differences between the different dose conditions. Discussion The VAULT protocol was an efficacious treatment that has the potential to increase the spoken vocabulary of late-talking toddlers and provides clinicians some flexibility in terms of number of words targeted and dose number, keeping in mind the interconnectedness of treatment parameters. Supplemental Material https://doi.org/10.23641/asha.11593323.",2020,"The VAULT protocol was an efficacious treatment that has the potential to increase the spoken vocabulary of late-talking toddlers and provides clinicians some flexibility in terms of number of words targeted and dose number, keeping in mind the interconnectedness of treatment parameters.","['16 sessions with 24 primarily monolingual English-speaking late talkers', 'late talkers in 2 conditions']",['Vocabulary Acquisition and Usage for Late Talkers (VAULT'],[],"[{'cui': 'C3540738', 'cui_str': 'English [International Organization for Standardization 639-1 code en] language reference set (foundation metadata concept)'}, {'cui': 'C0234856', 'cui_str': 'Using spoken communication'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0457083', 'cui_str': 'Usage (attribute)'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}]",[],,0.0318903,"The VAULT protocol was an efficacious treatment that has the potential to increase the spoken vocabulary of late-talking toddlers and provides clinicians some flexibility in terms of number of words targeted and dose number, keeping in mind the interconnectedness of treatment parameters.","[{'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Alt', 'Affiliation': 'Department of Speech, Language, and Hearing Sciences, The University of Arizona, Tucson.'}, {'ForeName': 'Heidi M', 'Initials': 'HM', 'LastName': 'Mettler', 'Affiliation': 'Department of Speech, Language, and Hearing Sciences, The University of Arizona, Tucson.'}, {'ForeName': 'Jessie A', 'Initials': 'JA', 'LastName': 'Erikson', 'Affiliation': 'Department of Speech, Language, and Hearing Sciences, The University of Arizona, Tucson.'}, {'ForeName': 'Cecilia R', 'Initials': 'CR', 'LastName': 'Figueroa', 'Affiliation': 'Department of Speech, Language, and Hearing Sciences, The University of Arizona, Tucson.'}, {'ForeName': 'Sarah E', 'Initials': 'SE', 'LastName': 'Etters-Thomas', 'Affiliation': 'Department of Speech, Language, and Hearing Sciences, The University of Arizona, Tucson.'}, {'ForeName': 'Genesis D', 'Initials': 'GD', 'LastName': 'Arizmendi', 'Affiliation': 'Department of Speech, Language, and Hearing Sciences, The University of Arizona, Tucson.'}, {'ForeName': 'Trianna', 'Initials': 'T', 'LastName': 'Oglivie', 'Affiliation': 'Department of Speech, Language, and Hearing Sciences, The University of Arizona, Tucson.'}]","Journal of speech, language, and hearing research : JSLHR",['10.1044/2019_JSLHR-19-00219'] 189,32163799,Effect of sugar administration on cortisol responses to acute psychosocial stress.,"Sugar administration prior acute psychosocial stress exposure was shown to enhance subsequent salivary cortisol responses. However, this finding is based on studies that have administered high doses of glucose to male subjects after long fasting periods. Therefore, in the present study, we investigated the effect of different sugar-containing drinks on acute cortisol stress responses under experimental conditions that are commonplace in stress research and our sample included females and males. Our primary aim was to derive feasible recommendations for a standardized sugar administration in future studies. Of the 103 healthy young participants (49 females, 54 males), 72 were confronted with the Trier Social Stress Test after being randomly assigned to one of three sugar conditions (200 ml of grape juice, a 75 g glucose or a 75 g maltodextrin drink); 31 subjects served as control sample and were exposed to the TSST without sugar administration. Cortisol stress responses were significantly enhanced in the grape juice as well as the glucose group as compared to the control group. Post hoc analysis revealed that this effect seemed to be more pronounced in males than in females. We did not find a significant effect of maltodextrin. Cortisol responder rates in all three experimental groups were higher than in the control group. Our results suggest that, at least in males, the administration of 200 ml of grape juice is sufficient to facilitate HPA axis reactivity and to minimize confounding effects due to interindividual differences in energy availability while being exposed to a laboratory stress paradigm. The unexpected gender-specific effect is of potential relevance and should be scrutinized in future studies.",2020,Cortisol stress responses were significantly enhanced in the grape juice as well as the glucose group as compared to the control group.,"['sample included females and males', '103\u202fhealthy young participants (49 females, 54 males), 72 were confronted with the Trier Social Stress Test after being randomly assigned to one of three', 'male subjects after long fasting periods', 'acute psychosocial stress']","['sugar conditions (200\u202fml of grape juice, a 75\u202fg glucose or a 75\u202fg maltodextrin drink); 31 subjects served as control sample and were exposed to the TSST without sugar administration', 'maltodextrin', 'sugar administration', 'sugar-containing drinks']","['Cortisol stress responses', 'subsequent salivary cortisol responses', 'cortisol responses', 'Cortisol responder rates', 'acute cortisol stress responses']","[{'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C4517526', 'cui_str': 'One hundred and three'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0065404', 'cui_str': 'Tri (L)'}, {'cui': 'C0015260', 'cui_str': 'Exercise Test'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}]","[{'cui': 'C0242209', 'cui_str': 'Sugars'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0452455', 'cui_str': 'Grape juice (substance)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0065601', 'cui_str': 'maltodextrin'}, {'cui': 'C0452428', 'cui_str': 'Drinks (substance)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0332157', 'cui_str': 'Exposure to (contextual qualifier) (qualifier value)'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}]","[{'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0442040', 'cui_str': 'Salivary (qualifier value)'}]",,0.027942,Cortisol stress responses were significantly enhanced in the grape juice as well as the glucose group as compared to the control group.,"[{'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Zänkert', 'Affiliation': 'University of Regensburg, Germany.'}, {'ForeName': 'Brigitte M', 'Initials': 'BM', 'LastName': 'Kudielka', 'Affiliation': 'University of Regensburg, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Wüst', 'Affiliation': 'University of Regensburg, Germany. Electronic address: stefan.wuest@ur.de.'}]",Psychoneuroendocrinology,['10.1016/j.psyneuen.2020.104607'] 190,31357206,Pharmacological mechanisms of interhemispheric signal propagation: a TMS-EEG study.,"Interhemispheric connections across the corpus callosum have a predominantly inhibitory effect. Previous electrophysiology studies imply that local inhibitory circuits are responsible for inducing transcallosal inhibition, likely through inhibitory GABA B -mediated neurotransmission. We investigated the neurochemical mechanisms involved in interhemispheric connectivity by measuring transcranial magnetic stimulation (TMS)-induced interhemispheric signal propagation (ISP) in the motor cortex and dorsolateral prefrontal cortex (DLPFC) with electroencephalography (EEG) recordings under the pharmacological effects of baclofen, L-DOPA, dextromethorphan, and rivastigmine. We hypothesized that for both stimulated regions, GABA B receptor agonist baclofen would decrease ISP when compared against baseline while drugs that target other neurotransmitter systems (dopaminergic, acetylcholinergic, and glutamatergic systems) would have no effect on ISP. Twelve right-handed healthy volunteers completed this study and underwent TMS across five sessions in a randomized order. In the motor cortex, participants showed a significant decrease in ISP under baclofen, but not in the other drug conditions. There were no drug-induced changes in ISP in the DLPFC and baseline ISP did not differ across experimental sessions for both brain regions. Together, our results suggest that the inhibitory effects observed with interhemispheric signal transmission are mediated by a population of interneurons involving GABA B receptor neurotransmission. Inhibitory mechanisms of ISP may be more salient for motor-related functions in the motor cortex than for cognitive control in the DLPFC. These findings are a fundamental step in advancing our understanding of interhemispheric connectivity and may be used to identify treatments for disorders in which transcallosal transmission is dysfunctional.",2020,"In the motor cortex, participants showed a significant decrease in ISP under baclofen, but not in the other drug conditions.",['Twelve right-handed healthy volunteers'],"['baclofen, L-DOPA, dextromethorphan, and rivastigmine', 'TMS', 'transcranial magnetic stimulation (TMS)-induced interhemispheric signal propagation (ISP']","['ISP under baclofen', 'ISP']","[{'cui': 'C0344333', 'cui_str': 'Right handed (finding)'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0004609', 'cui_str': 'Baclofen'}, {'cui': 'C0023570', 'cui_str': 'Levodopa'}, {'cui': 'C0011816', 'cui_str': 'Dextromethorphan'}, {'cui': 'C0649350', 'cui_str': 'rivastigmine'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation (procedure)'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}]","[{'cui': 'C0004609', 'cui_str': 'Baclofen'}]",12.0,0.0545946,"In the motor cortex, participants showed a significant decrease in ISP under baclofen, but not in the other drug conditions.","[{'ForeName': 'Jeanette', 'Initials': 'J', 'LastName': 'Hui', 'Affiliation': 'Temerty Centre for Therapeutic Brain Intervention, Centre for Addiction and Mental Health, Toronto, ON, Canada.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Zomorrodi', 'Affiliation': 'Temerty Centre for Therapeutic Brain Intervention, Centre for Addiction and Mental Health, Toronto, ON, Canada.'}, {'ForeName': 'Pantelis', 'Initials': 'P', 'LastName': 'Lioumis', 'Affiliation': 'Temerty Centre for Therapeutic Brain Intervention, Centre for Addiction and Mental Health, Toronto, ON, Canada.'}, {'ForeName': 'Bahar', 'Initials': 'B', 'LastName': 'Salavati', 'Affiliation': 'Institute of Medical Science, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Tarek K', 'Initials': 'TK', 'LastName': 'Rajji', 'Affiliation': 'Temerty Centre for Therapeutic Brain Intervention, Centre for Addiction and Mental Health, Toronto, ON, Canada.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Chen', 'Affiliation': 'Institute of Medical Science, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Daniel M', 'Initials': 'DM', 'LastName': 'Blumberger', 'Affiliation': 'Temerty Centre for Therapeutic Brain Intervention, Centre for Addiction and Mental Health, Toronto, ON, Canada.'}, {'ForeName': 'Zafiris J', 'Initials': 'ZJ', 'LastName': 'Daskalakis', 'Affiliation': 'Temerty Centre for Therapeutic Brain Intervention, Centre for Addiction and Mental Health, Toronto, ON, Canada. Jeff.Daskalakis@camh.ca.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0468-7'] 191,30663898,Sedentary lifestyle associated with mortality in rural patients with heart failure.,"BACKGROUND The incidence of mortality five years after the onset of symptomatic heart failure is about 50%. Lifestyle behaviors differ substantially and likely lead to prognostic differences. AIMS We sought to determine the factors associated with all-cause mortality in patients with heart failure, particularly the impact of a sedentary lifestyle on mortality. METHODS This is a secondary analysis of a randomized controlled trial (REMOTE-HF) to improve self-care through education and counseling ( N=602). We conducted an unadjusted Cox proportional hazards regression analysis with sedentary lifestyle as a predictor of mortality, then added depressive symptoms as a confounder. A Kaplan-Meier survival analysis assessed time to event comparing sedentary lifestyle. Cox models included variables of clinical relevance as well as all significant variables from baseline characteristics associated with all-cause mortality. RESULTS The mean ± SD age was 66 ± 12.4 years, 41% were women, and 90% were of white race. There were 125 all-cause deaths over 24 months. Sedentary lifestyle was associated with a 75% increase in the expected hazard of all-cause mortality (hazards ratio 1.75; p = 0.003; 95% CI 1.21-2.54) after adjusting for moderate to severe depressive symptoms. Two Cox models showed an 89 and 95% increase, respectively, in all-cause mortality in sedentary participants holding all other variables constant. CONCLUSIONS Sedentary lifestyle is strongly associated with all-cause mortality, independent of having moderate to severe depressive symptoms. Clinicians and researchers have an important role in promoting sustained and safe physical activity to improve survival. Other important modifiable targets to improve survival include depressive symptoms, low literacy, and low body mass index. Clinical Trial Registration- URL: https://www.clinicaltrials.gov . Unique Identifier: NCT00415545.",2019,Sedentary lifestyle was associated with a 75% increase in the expected hazard of all-cause mortality (hazards ratio 1.75; p = 0.003; 95% CI 1.21-2.54) after adjusting for moderate to severe depressive symptoms.,"['rural patients with heart failure', 'The mean ± SD age was 66 ± 12.4 years, 41% were women, and 90% were of white race', 'patients with heart failure']",[],['expected hazard of all-cause mortality'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517543', 'cui_str': '12.4 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C3853635', 'cui_str': 'Race (observable entity)'}]",[],"[{'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}]",,0.222812,Sedentary lifestyle was associated with a 75% increase in the expected hazard of all-cause mortality (hazards ratio 1.75; p = 0.003; 95% CI 1.21-2.54) after adjusting for moderate to severe depressive symptoms.,"[{'ForeName': 'Linda G', 'Initials': 'LG', 'LastName': 'Park', 'Affiliation': '1 Department of Community Health Systems, University of California, San Francisco, School of Nursing, San Francisco Veterans Affairs Medical Center, USA.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Dracup', 'Affiliation': '2 University of California, San Francisco, School of Nursing, USA.'}, {'ForeName': 'Mary A', 'Initials': 'MA', 'LastName': 'Whooley', 'Affiliation': '3 Department of Medicine and Epidemiology & Biostatistics, University of California, San Francisco, San Francisco Veterans Affairs Medical Center, USA.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'McCulloch', 'Affiliation': '4 Department of Epidemiology & Biostatistics, University of California, San Francisco, USA.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Lai', 'Affiliation': '2 University of California, San Francisco, School of Nursing, USA.'}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Howie-Esquivel', 'Affiliation': '5 University of Virginia, School of Nursing, USA.'}]",European journal of cardiovascular nursing : journal of the Working Group on Cardiovascular Nursing of the European Society of Cardiology,['10.1177/1474515118822967'] 192,30726109,Nurse-performed venous sheath removal in patients undergoing radiofrequency catheter ablation for atrial fibrillation: a randomised study.,"BACKGROUND Catheter ablation procedures have recently become a widely accepted method for treating cardiac arrhythmias, and referrals for these procedures have been steadily increasing. As a result, it is now common that sheath removal is handled as a nursing procedure. Regardless of who performs the sheath removal, it is important to extract ablation sheaths without any early or late complications. OBJECTIVE The aim of this randomised study was to determine the safety of sheath extraction after heparin reversal with low-dose protamine sulfate in patients undergoing radiofrequency catheter ablation for atrial fibrillation and whether these sheaths can be safely removed by nurses. METHODS Eighty-one patients were randomly assigned to either receiving protamine to reverse heparin after an ablation ( n=40) or to the standard protocol without heparin reversal ( n=41). Nurse-led sheath removal was done in the cath lab (protamine group) or on the ward (standard group) as soon as activated partial thromboplastin time dropped below 60 s. All adverse events, groin compression time, immobilisation time and procedure characteristics were recorded. RESULTS The manual compression time for the standard group was significantly longer than for the protamine group (15.9 ± 2.5 vs. 21.9 ± 3.1 minutes, P<0.001) as well as the total immobilisation time (13.2 ± 2.4 vs. 20.3 ± 3.8 hours, P=0.01). Minor groin haematomas occurred less frequently in the protamine group (4 vs. 12, P=0.02) and the haematomas tended to be smaller (4.1 ± 2.1 vs. 5.2 ± 2.5 cm, P=0.09). No serious adverse events were observed when the femoral sheaths were extracted by specially trained staff nurses. CONCLUSION Fewer and milder complications and shorter immobilisation times were reported with protamine reversal compared to the conventional method. Staff nurses can safely remove femoral venous sheaths after a radiofrequency ablation for atrial fibrillation.",2019,"Minor groin haematomas occurred less frequently in the protamine group (4 vs. 12, P=0.02) and the haematomas tended to be smaller (4.1 ± 2.1 vs. 5.2 ± 2.5 cm, P=0.09).","['for atrial fibrillation', 'patients undergoing radiofrequency catheter ablation for atrial fibrillation', 'patients undergoing', '\n\n\nEighty-one patients']","['protamine to reverse heparin after an ablation ( n=40) or to the standard protocol without heparin reversal', 'heparin reversal with low-dose protamine sulfate', 'radiofrequency catheter ablation', 'Nurse-performed venous sheath removal']","['Minor groin haematomas', 'milder complications and shorter immobilisation times', 'total immobilisation time', 'adverse events, groin compression time, immobilisation time and procedure characteristics', 'serious adverse events', 'manual compression time']","[{'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0162561', 'cui_str': 'Catheter Ablation, Radiofrequency'}, {'cui': 'C4517884', 'cui_str': '81'}]","[{'cui': 'C0033603', 'cui_str': 'Protamines'}, {'cui': 'C0019134', 'cui_str': 'heparin'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0033602', 'cui_str': 'Protamine Sulfate (USP)'}, {'cui': 'C0162561', 'cui_str': 'Catheter Ablation, Radiofrequency'}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0348013', 'cui_str': 'Venous (qualifier value)'}, {'cui': 'C0009653', 'cui_str': 'Condoms'}, {'cui': 'C0015252', 'cui_str': 'Removal - action (qualifier value)'}]","[{'cui': 'C0026193', 'cui_str': 'Minors'}, {'cui': 'C0018246', 'cui_str': 'Groin'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0020944', 'cui_str': 'Immobilization'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0332459', 'cui_str': 'Compression (morphologic abnormality)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0175674', 'cui_str': 'Manual (qualifier value)'}]",81.0,0.0598886,"Minor groin haematomas occurred less frequently in the protamine group (4 vs. 12, P=0.02) and the haematomas tended to be smaller (4.1 ± 2.1 vs. 5.2 ± 2.5 cm, P=0.09).","[{'ForeName': 'Lucie', 'Initials': 'L', 'LastName': 'Rolantova', 'Affiliation': '1 Faculty of Health and Social Sciences, The University of South Bohemia in Ceske Budejovice, Czech Republic.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Bulava', 'Affiliation': '1 Faculty of Health and Social Sciences, The University of South Bohemia in Ceske Budejovice, Czech Republic.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Eisenberger', 'Affiliation': '2 Department of Cardiology, Ceske Budejovice Hospital, Czech Republic.'}, {'ForeName': 'Ivana', 'Initials': 'I', 'LastName': 'Chloubova', 'Affiliation': '1 Faculty of Health and Social Sciences, The University of South Bohemia in Ceske Budejovice, Czech Republic.'}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Tothova', 'Affiliation': '1 Faculty of Health and Social Sciences, The University of South Bohemia in Ceske Budejovice, Czech Republic.'}, {'ForeName': 'Jiri', 'Initials': 'J', 'LastName': 'Hanis', 'Affiliation': '2 Department of Cardiology, Ceske Budejovice Hospital, Czech Republic.'}]",European journal of cardiovascular nursing : journal of the Working Group on Cardiovascular Nursing of the European Society of Cardiology,['10.1177/1474515119830297'] 193,31298628,A Digital Preprocedure Instruction Program for Outpatient Colonoscopy.,"Introduction: Many patients struggle with colonoscopy preparation, which is complex and can be an uncomfortable as well as a time-consuming process. The confusion and anxiety from the preprocedure process may lead patients to delay their colonoscopy or skip it altogether. Digital health technology that focuses on patient engagement can play an important role in promoting colorectal cancer screening. Methods: A digital preprocedure instruction program was implemented for outpatient colonoscopy by sending critical reminders and instructions to patients through a series of short message service messages and/or emails. Eligible patients included English speakers on GoLYTELY ® /NuLYTELY ® or MiraLAX ® preparation regimens with a valid cellphone or email address in the electronic health record. We examined the impact of digital instructions on bowel preparation quality, no-show and same-day cancellations over a 3-month period between an intervention group of 756 patients and a control group of 2,103 patients. Patients who enrolled in the digital instructions also received a patient satisfaction survey. Results: Our controlled study demonstrated the effectiveness of digital instructions to reduce no-show and same-day cancellation rates for outpatient colonoscopy from 10.40% to 6.08% ( p < 0.001). Bowel preparation quality was not significantly different between the two groups ( p  = 0.23). However, 90% of patients who enrolled in the program rated their satisfaction with the digital reminders very highly. Discussion: A digital preprocedure instruction program can have a positive impact on operational efficiency, quality of care, and patient satisfaction. This study shows how digital health tools can effectively engage patients scheduled for a colonoscopy, increase appointment adherence, and, therefore, lead to better cancer screening.",2020,Our controlled study demonstrated the effectiveness of digital instructions to reduce no-show and same-day cancellation rates for outpatient colonoscopy from 10.40% to 6.08% ( p < 0.001).,"['Patients who enrolled in the digital instructions also received a patient satisfaction survey', '756 patients and a control group of 2,103 patients', 'Eligible patients included English speakers on GoLYTELY ® /NuLYTELY ® or MiraLAX ® preparation regimens with a valid cellphone or email address in the electronic health record']",[],"['Bowel preparation quality', 'operational efficiency, quality of care, and patient satisfaction']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray (qualifier value)'}, {'cui': 'C0039401', 'cui_str': 'Teaching'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C3540738', 'cui_str': 'English [International Organization for Standardization 639-1 code en] language reference set (foundation metadata concept)'}, {'cui': 'C0061795', 'cui_str': 'Golytely'}, {'cui': 'C0876088', 'cui_str': 'Miralax'}, {'cui': 'C0013849', 'cui_str': 'Email'}, {'cui': 'C0376649', 'cui_str': 'Address'}, {'cui': 'C2362543', 'cui_str': 'Electronic Medical Record'}]",[],"[{'cui': 'C0455052', 'cui_str': 'Preparation of bowel for procedure (procedure)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0034379', 'cui_str': 'Quality of Care'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}]",2103.0,0.0228979,Our controlled study demonstrated the effectiveness of digital instructions to reduce no-show and same-day cancellation rates for outpatient colonoscopy from 10.40% to 6.08% ( p < 0.001).,"[{'ForeName': 'James M', 'Initials': 'JM', 'LastName': 'Richter', 'Affiliation': 'Division of Gastroenterology, Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Jasmine B', 'Initials': 'JB', 'LastName': 'Ha', 'Affiliation': 'Division of Gastroenterology, Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Madeline', 'Initials': 'M', 'LastName': 'Marx', 'Affiliation': 'Division of Gastroenterology, Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Emily J', 'Initials': 'EJ', 'LastName': 'Campbell', 'Affiliation': 'Division of Gastroenterology, Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Michael C', 'Initials': 'MC', 'LastName': 'Pandolfi', 'Affiliation': 'Division of Gastroenterology, Massachusetts General Hospital, Boston, Massachusetts.'}]",Telemedicine journal and e-health : the official journal of the American Telemedicine Association,['10.1089/tmj.2019.0050'] 194,32320088,"Efficacy of risankizumab in patients with moderate-to-severe plaque psoriasis by baseline demographics, disease characteristics and prior biologic therapy: an integrated analysis of the phase III UltIMMa-1 and UltIMMa-2 studies.","BACKGROUND Risankizumab is a humanized IgG monoclonal antibody that selectively inhibits interleukin-23 through binding the p19 subunit. In Phase 3 trials, risankizumab demonstrated superior efficacy compared with adalimumab and ustekinumab in patients with moderate-to-severe plaque psoriasis. Here, we evaluated the impact of baseline characteristics on efficacy of risankizumab compared with ustekinumab in patients with moderate-to-severe plaque psoriasis. METHODS This analysis included all patients initially randomized to risankizumab or ustekinumab from the replicate, double-blinded, randomized, placebo-controlled phase 3 trials, UltIMMa-1 (NCT02684370) and UltIMMa-2 (NCT02684357). Patients received either risankizumab (150 mg) or ustekinumab (weight-based; 45 or 90 mg per label) at weeks 0, 4, 16, 28 and 40. Efficacy was assessed as the proportion of patients achieving ≥90% improvement in Psoriasis Area and Severity Index (PASI 90) at weeks 16 and 52 by baseline patient demographics, disease characteristics and prior biologic exposure. Mean per cent improvement in PASI was calculated by body weight and body mass index at week 52. Missing efficacy data were imputed as non-responders for categorical variables and last observation carried forward for continuous variables. Logistic regression analyses assessed for interactions between treatment and five independent variables (age, sex, weight, baseline PASI score and presence of psoriatic arthritis) at both weeks 16 and 52. RESULTS Baseline patient demographics, disease characteristics and prior biologic exposure were similar between patients randomized to risankizumab (n = 598) and ustekinumab (n = 199). At weeks 16 and 52, risankizumab demonstrated superior efficacy compared with ustekinumab across these patient characteristics (P < 0.01). Logistic regression analyses demonstrated that risankizumab was superior to ustekinumab at weeks 16 and 52 in all models tested (P < 0.0001 for all). CONCLUSIONS Risankizumab demonstrated consistent and superior efficacy compared with ustekinumab regardless of patient demographics, disease characteristics or prior biologic exposure.",2020,"Logistic regression analyses demonstrated that risankizumab was superior to ustekinumab at weeks 16 and 52 in all models tested (P<0.0001 for all). ","['patients with moderate-to-severe plaque psoriasis', 'Patients with Moderate-to-Severe Plaque Psoriasis by Baseline Demographics, Disease Characteristics and Prior Biologic Therapy']","['adalimumab and ustekinumab', 'ustekinumab', 'Risankizumab', 'placebo', 'risankizumab', 'risankizumab or ustekinumab']","['PASI', 'Psoriasis Area and Severity Index', 'Efficacy']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0406317', 'cui_str': 'Chronic small plaque psoriasis'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0005527', 'cui_str': 'Biotherapy'}]","[{'cui': 'C1122087', 'cui_str': 'adalimumab'}, {'cui': 'C1608841', 'cui_str': 'ustekinumab'}, {'cui': 'C4505511', 'cui_str': 'risankizumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",,0.135887,"Logistic regression analyses demonstrated that risankizumab was superior to ustekinumab at weeks 16 and 52 in all models tested (P<0.0001 for all). ","[{'ForeName': 'B', 'Initials': 'B', 'LastName': 'Strober', 'Affiliation': 'Yale University, New Haven, CT, USA.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Menter', 'Affiliation': 'Baylor Scott and White, Dallas, TX, USA.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Leonardi', 'Affiliation': 'Central Dermatology, Richmond Heights, MO, USA.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Gordon', 'Affiliation': 'Medical College of Wisconsin, Milwaukee, WI, USA.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Lambert', 'Affiliation': 'Ghent University, Ghent, Belgium.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Puig', 'Affiliation': 'Hospital de la Santa Creu i Sant Pau, Barcelona, Spain.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Photowala', 'Affiliation': 'AbbVie, Inc., North Chicago, IL, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Longcore', 'Affiliation': 'AbbVie, Inc., North Chicago, IL, USA.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Zhan', 'Affiliation': 'AbbVie, Inc., North Chicago, IL, USA.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Foley', 'Affiliation': ""St. Vincent's Hospital Melbourne, Probity Medical Research, Skin Health Institute, The University of Melbourne, Melbourne, VIC, Australia.""}]",Journal of the European Academy of Dermatology and Venereology : JEADV,['10.1111/jdv.16521'] 195,31961967,Six-dimensional quantitative DCE MR Multitasking of the entire abdomen: Method and application to pancreatic ductal adenocarcinoma.,"PURPOSE To develop a quantitative DCE MRI technique enabling entire-abdomen coverage, free-breathing acquisition, 1-second temporal resolution, and T 1 -based quantification of contrast agent concentration and kinetic modeling for the characterization of pancreatic ductal adenocarcinoma (PDAC). METHODS Segmented FLASH readouts following saturation-recovery preparation with randomized 3D Cartesian undersampling was used for incoherent data acquisition. MR Multitasking was used to reconstruct 6-dimensional images with 3 spatial dimensions, 1 T 1 recovery dimension for dynamic T 1 quantification, 1 respiratory dimension to resolve respiratory motion, and 1 DCE time dimension to capture the contrast kinetics. Sixteen healthy subjects and 14 patients with pathologically confirmed PDAC were recruited for the in vivo studies, and kinetic parameters v p , K trans , v e , and K ep were evaluated for each subject. Intersession repeatability of Multitasking DCE was assessed in 8 repeat healthy subjects. One-way unbalanced analysis of variance was performed between control and patient groups. RESULTS In vivo studies demonstrated that v p , K trans , and K ep of PDAC were significantly lower compared with nontumoral regions in the patient group (P = .002, .003, .004, respectively) and normal pancreas in the control group (P = .011, <.001, <.001, respectively), while v e was significantly higher than nontumoral regions (P < .001) and healthy pancreas (P < .001). The kinetic parameters showed good in vivo repeatability (interclass correlation coefficient: v p , 0.95; K trans , 0.98; v e , 0.96; K ep , 0.99). CONCLUSION The proposed Multitasking DCE is promising for the quantification of vascular properties of PDAC. Quantitative DCE parameters were repeatable in vivo and showed significant differences between normal pancreas and both tumor and nontumoral regions in patients with PDAC.",2020,while v e was significantly higher than nontumoral regions (P < .001) and healthy pancreas (P < .001).,"['8 repeat healthy subjects', 'patients with PDAC', 'Sixteen healthy subjects and 14 patients with pathologically confirmed PDAC', 'entire abdomen', 'pancreatic ductal adenocarcinoma']",['Multitasking DCE'],"['healthy pancreas', 'K trans , and K ep of PDAC', 'vivo repeatability']","[{'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0439751', 'cui_str': 'Entire (qualifier value)'}, {'cui': 'C0000726', 'cui_str': 'Abdomen'}, {'cui': 'C0001418', 'cui_str': 'Adenoma, Malignant'}]",[],[],16.0,0.0351948,while v e was significantly higher than nontumoral regions (P < .001) and healthy pancreas (P < .001).,"[{'ForeName': 'Nan', 'Initials': 'N', 'LastName': 'Wang', 'Affiliation': 'Biomedical Imaging Research Institute, Cedars-Sinai Medical Center, Los Angeles, California.'}, {'ForeName': 'Srinivas', 'Initials': 'S', 'LastName': 'Gaddam', 'Affiliation': 'Division of Digestive and Liver Diseases, Cedars-Sinai Medical Center, Los Angeles, California.'}, {'ForeName': 'Lixia', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Biomedical Imaging Research Institute, Cedars-Sinai Medical Center, Los Angeles, California.'}, {'ForeName': 'Yibin', 'Initials': 'Y', 'LastName': 'Xie', 'Affiliation': 'Biomedical Imaging Research Institute, Cedars-Sinai Medical Center, Los Angeles, California.'}, {'ForeName': 'Zhaoyang', 'Initials': 'Z', 'LastName': 'Fan', 'Affiliation': 'Biomedical Imaging Research Institute, Cedars-Sinai Medical Center, Los Angeles, California.'}, {'ForeName': 'Wensha', 'Initials': 'W', 'LastName': 'Yang', 'Affiliation': 'Department of Clinical Radiation Oncology, University of Southern California, Los Angeles, California.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Tuli', 'Affiliation': 'Department of Radiation Oncology, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Lo', 'Affiliation': 'Division of Digestive and Liver Diseases, Cedars-Sinai Medical Center, Los Angeles, California.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Hendifar', 'Affiliation': 'Department of Gastrointestinal Malignancies, Cedars-Sinai Medical Center, Los Angeles, California.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Pandol', 'Affiliation': 'Division of Digestive and Liver Diseases, Cedars-Sinai Medical Center, Los Angeles, California.'}, {'ForeName': 'Anthony G', 'Initials': 'AG', 'LastName': 'Christodoulou', 'Affiliation': 'Biomedical Imaging Research Institute, Cedars-Sinai Medical Center, Los Angeles, California.'}, {'ForeName': 'Debiao', 'Initials': 'D', 'LastName': 'Li', 'Affiliation': 'Biomedical Imaging Research Institute, Cedars-Sinai Medical Center, Los Angeles, California.'}]",Magnetic resonance in medicine,['10.1002/mrm.28167'] 196,32301894,"Effect of Chinese herbal medicine on serum lipids in postmenopausal women with mild dyslipidemia: a randomized, placebo-controlled clinical trial.","OBJECTIVE Previous studies have shown the association between menopause and dyslipidemia. This study was aimed to evaluate the effect of Chinese herbal medicine, tonifying kidney and descending turbidity (TKDT) granule, on serum lipid profiles in postmenopausal women with dyslipidemia. METHODS A double-blind randomized, placebo-controlled trial was conducted among 104 postmenopausal Chinese women with mild dyslipidemia. Participants were randomized into treatment group (n = 53) and control group (n = 51). The participants in the treatment group received TKDT granule once per day for 24 weeks, whereas the control group received placebo in the same manner. All participants were subjected to healthy lifestyle during the study. Serum lipid profiles, body weight, waist circumference, and safety indicators were measured both at baseline and 24 weeks after admission. RESULTS Compared with placebo, significant improvements in total cholesterol, low-density lipoprotein cholesterol, apolipoprotein-B (Apo-B), weight, and waist circumference in the TKDT group (P < 0.05) were observed after 24 weeks of treatment. Total cholesterol, low-density lipoprotein cholesterol, and Apo-B were decreased by 0.84 (0.77) mmol/L, 0.72 (0.77) mmol/L, and 0.12 (0.27) mmol/L, mean ± SD respectively. The weight, waist circumference, and body mass index were decreased by 4.07 (3.01) kg, 3.10 (2.95) cm, 1.60 (1.13), respectively. There were no significant differences in triglycerides, high-density lipoprotein cholesterol, and Apo-A between the two groups. Seven participants in the treatment group and six participants in the placebo group had mild or moderate adverse reactions. CONCLUSION TKDT granule improved the lipid profile and reduced the related metabolic abnormalities in postmenopausal women with mild dyslipidemia based on lifestyle changes.",2020,"Compared with placebo, significant improvements in total cholesterol, low-density lipoprotein cholesterol, apolipoprotein-B (Apo-B), weight, and waist circumference in the TKDT group (P < 0.05) were observed after 24 weeks of treatment.","['postmenopausal women with mild dyslipidemia based on lifestyle changes', '104 postmenopausal Chinese women with mild dyslipidemia', 'postmenopausal women with mild dyslipidemia', 'postmenopausal women with dyslipidemia', 'All participants were subjected to healthy lifestyle during the study']","['TKDT granule', 'Chinese herbal medicine, tonifying kidney and descending turbidity (TKDT', 'placebo', 'Chinese herbal medicine']","['triglycerides, high-density lipoprotein cholesterol, and Apo-A', 'Total cholesterol, low-density lipoprotein cholesterol, and Apo-B', 'serum lipid profiles, body weight, waist circumference, and safety indicators', 'lipid profile', 'metabolic abnormalities', 'serum lipid profiles', 'total cholesterol, low-density lipoprotein cholesterol, apolipoprotein-B (Apo-B), weight, and waist circumference', 'mild or moderate adverse reactions', 'serum lipids', 'weight, waist circumference, and body mass index']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0242339', 'cui_str': 'Dyslipidemia'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C4277664', 'cui_str': 'Healthy Lifestyles'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0205386', 'cui_str': 'Descending'}, {'cui': 'C4319582', 'cui_str': 'Turbidity (property)'}, {'cui': 'C0010837', 'cui_str': 'Cytoplasmic Granules'}, {'cui': 'C1273412', 'cui_str': 'Chinese herbal medicine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0023822', 'cui_str': 'HDL cholesterol'}, {'cui': 'C0003592', 'cui_str': 'Apolipoprotein A'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0003593', 'cui_str': 'Apolipoprotein B'}, {'cui': 'C0428462', 'cui_str': 'Measurement of serum lipid level'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0000768', 'cui_str': 'Congenital malformation'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]",104.0,0.39623,"Compared with placebo, significant improvements in total cholesterol, low-density lipoprotein cholesterol, apolipoprotein-B (Apo-B), weight, and waist circumference in the TKDT group (P < 0.05) were observed after 24 weeks of treatment.","[{'ForeName': 'Guangning', 'Initials': 'G', 'LastName': 'Nie', 'Affiliation': 'Department of Gynecology, Second Affiliated Hospital of Guangzhou University of Chinese Medicine (Guangdong Provincial Hospital of Chinese Medicine), Guangzhou, China.'}, {'ForeName': 'Hongyan', 'Initials': 'H', 'LastName': 'Yang', 'Affiliation': ''}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': ''}, {'ForeName': 'Xiaojing', 'Initials': 'X', 'LastName': 'Cao', 'Affiliation': ''}, {'ForeName': 'Fangping', 'Initials': 'F', 'LastName': 'Cheng', 'Affiliation': ''}, {'ForeName': 'Qiaolin', 'Initials': 'Q', 'LastName': 'Du', 'Affiliation': ''}, {'ForeName': 'Xiaoyun', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': ''}]","Menopause (New York, N.Y.)",['10.1097/GME.0000000000001539'] 197,30797707,Clinical prognostic model for older patients with advanced non-small cell lung cancer.,"BACKGROUND Older patients with non-small cell lung cancer (NSCLC) are often not prescribed standard therapy. It is important to know which older patients would be candidates for aggressive therapy based on their prognosis, and to develop a model that can help determine prognosis. METHODS Data on older patients (≥70 years) enrolled on 38 NCI cooperative group trials of advanced NSCLC from 1991 to 2011 were analyzed. Multivariable Cox PH model was built with a stepwise selection. We derived a prognostic score using the estimated Cox PH regression coefficient. We then calculated the area under receiver operating characteristic (ROC) curve of survival in the testing set. RESULTS The final analysis included 1467 patients, who were randomly divided into a training (n = 963) and a testing set (n = 504). The prognostic risk score was calculated as: 3 (if male) + 3 (if PS = 1) + 8 (if PS = 2) + 11 (if initial stage = IV) + 4 (if weight loss). Patients were classified into two prognostic groups: good (0-8) and poor (≥9). The median survival in the two groups in the testing set were 13.15 (95% CI, 10.82-15.91) and 8.52 months (95% CI, 7.5-9.63), respectively. The model had area under the 1-year and 2-year ROCs (0.6 and 0.65, respectively) that were higher than existing models. CONCLUSIONS Male gender, poor performance status, distant metastases and recent weight loss predict for poor overall survival (OS) in older patients with advanced NSCLC. This study proposes a simple prognostic model for older adults with advanced NSCLC.",2019,"The median survival in the two groups in the testing set were 13.15 (95% CI, 10.82-15.91) and 8.52 months (95% CI, 7.5-9.63), respectively.","['older patients with advanced non-small cell lung cancer', 'older adults with advanced NSCLC', 'older patients (≥70\u202fyears) enrolled on 38 NCI cooperative group trials of advanced NSCLC from 1991 to 2011 were analyzed', 'Older patients with non-small cell lung cancer (NSCLC', '1467 patients', 'older patients', 'older patients with advanced NSCLC']",[],"['prognostic risk score', '1-year and 2-year ROCs', 'median survival']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1513882', 'cui_str': 'National Cancer Institute'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]",[],"[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",,0.0838813,"The median survival in the two groups in the testing set were 13.15 (95% CI, 10.82-15.91) and 8.52 months (95% CI, 7.5-9.63), respectively.","[{'ForeName': 'Apar Kishor', 'Initials': 'AK', 'LastName': 'Ganti', 'Affiliation': 'VA-Nebraska Western Iowa Health Care System; University of Nebraska Medical Center, Omaha, NE, USA. Electronic address: aganti@unmc.edu.'}, {'ForeName': 'Xiaofei', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Thomas E', 'Initials': 'TE', 'LastName': 'Stinchcombe', 'Affiliation': 'Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Yinpeng', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Bradley', 'Affiliation': 'Washington University School of Medicine, St. Louis, MO. USA.'}, {'ForeName': 'Harvey J', 'Initials': 'HJ', 'LastName': 'Cohen', 'Affiliation': 'Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Kelly', 'Affiliation': 'University of California Davis Cancer Center, Sacramento, CA. USA.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Paulus', 'Affiliation': 'NRG Oncology Statistics and Data Management Center, Pittsburgh, PA, USA.'}, {'ForeName': 'Suresh S', 'Initials': 'SS', 'LastName': 'Ramalingam', 'Affiliation': 'Winship Cancer Institute of Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Everett E', 'Initials': 'EE', 'LastName': 'Vokes', 'Affiliation': 'University of Chicago, Chicago, IL. USA.'}, {'ForeName': 'Herbert', 'Initials': 'H', 'LastName': 'Pang', 'Affiliation': 'Duke University Medical Center, Durham, NC, USA; Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong, China.'}]",Journal of geriatric oncology,['10.1016/j.jgo.2019.02.007'] 198,30919998,"A randomized double-blind, placebo-controlled clinical phase IIa trial on safety, immunomodulatory effects and pharmacokinetics of EA-230 during experimental human endotoxaemia.","AIMS EA-230 is a human chorionic gonadotropin hormone-derived linear tetrapeptide, developed for the treatment of systemic inflammation-related disorders. EA-230 has shown promising immunomodulatory and tissue-protective effects in animals and an excellent safety profile in human phase I studies that we performed. The present phase IIa study follows-up on these results by investigating the safety, efficacy and pharmacokinetics of EA-230 under systemic inflammatory conditions induced by experimental human endotoxaemia. METHODS In this randomized, double blind, placebo-controlled phase IIa study, systemic inflammation was induced by intravenous administration of Escherichia coli-derived lipopolysaccharide (LPS). At t = 0 hours, 36 healthy male volunteers received 2 ng/kg LPS, followed by a 2-hour continuous infusion of EA-230 (15, 45 and 90 mg/kg/h, n = 8 per group) or placebo (n = 12). RESULTS EA-230 was well tolerated and showed a favourable safety profile. Treatment with the highest dose of EA-230 resulted in a significant attenuation of the LPS-induced increase in plasma levels of inflammatory mediators interleukin (IL)-6, IL-8, IL-1 receptor antagonist, monocyte chemoattractant protein-1, macrophage inflammatory proteins-1α and -1β, and vascular cell adhesion protein-1 (% reduction of 48, 28, 33, 28, 14, 16 and 19 respectively, p < .01), and reduced fever (peak decrease from 1.8 ± 0.1°C to 1.3 ± 0.2°C, P < .05) and symptom scores (peak decrease from 7.4 ± 1.0 to 4.0 ± 1.2 points, P < .05). EA-230 exhibited a very short elimination half-life and a large volume of distribution in the highest dosage group (geometric mean and 95% confidence interval: 0.17 [0.12-0.24] hours and 2.2 [1.3-3.8] L/kg, respectively). CONCLUSION Administration of EA-230 is safe and results in attenuation of the systemic inflammatory response in humans.",2019,"Treatment with the highest dose of EA-230 resulted in a significant attenuation of the LPS-induced increase in plasma levels of inflammatory mediators interleukin (IL)-6, IL-8, IL-1 receptor antagonist, monocyte chemoattractant protein-1, macrophage inflammatory proteins-1α and -1β, and vascular cell adhesion protein-1 (% reduction of 48, 28, 33, 28, 14, 16 and 19 respectively, p < .01), and reduced fever (peak decrease from 1.8 ± 0.1°C to 1.3 ± 0.2°C, P ","['humans', '36 healthy male volunteers']","['Escherichia coli-derived lipopolysaccharide (LPS', 'placebo', 'EA-230']","['plasma levels of inflammatory mediators interleukin (IL)-6, IL-8, IL-1 receptor antagonist, monocyte chemoattractant protein-1, macrophage inflammatory proteins-1α and -1β, and vascular cell adhesion protein-1', 'reduced fever', 'symptom scores']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}]","[{'cui': 'C0014834', 'cui_str': 'Escherichia coli'}, {'cui': 'C0023810', 'cui_str': 'Lipoglycans'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4079739', 'cui_str': 'EA-230'}]","[{'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C0063710', 'cui_str': 'Receptors, IL-1'}, {'cui': 'C0243076', 'cui_str': 'antagonists'}, {'cui': 'C0128897', 'cui_str': 'Chemokine (C-C Motif) Ligand 2'}, {'cui': 'C0376579', 'cui_str': 'Macrophage Inflammatory Proteins'}, {'cui': 'C0007577', 'cui_str': 'Cell Adhesion'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0015967', 'cui_str': 'Hyperthermia'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",36.0,0.516988,"Treatment with the highest dose of EA-230 resulted in a significant attenuation of the LPS-induced increase in plasma levels of inflammatory mediators interleukin (IL)-6, IL-8, IL-1 receptor antagonist, monocyte chemoattractant protein-1, macrophage inflammatory proteins-1α and -1β, and vascular cell adhesion protein-1 (% reduction of 48, 28, 33, 28, 14, 16 and 19 respectively, p < .01), and reduced fever (peak decrease from 1.8 ± 0.1°C to 1.3 ± 0.2°C, P ","[{'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'van Groenendael', 'Affiliation': 'Department of Intensive Care Medicine, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Matthijs', 'Initials': 'M', 'LastName': 'Kox', 'Affiliation': 'Department of Intensive Care Medicine, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Guus', 'Initials': 'G', 'LastName': 'Leijte', 'Affiliation': 'Department of Intensive Care Medicine, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Bouke', 'Initials': 'B', 'LastName': 'Koeneman', 'Affiliation': 'Department of Intensive Care Medicine, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Jelle', 'Initials': 'J', 'LastName': 'Gerretsen', 'Affiliation': 'Department of Intensive Care Medicine, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Lucas', 'Initials': 'L', 'LastName': 'van Eijk', 'Affiliation': 'Department of Intensive Care Medicine, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Pickkers', 'Affiliation': 'Department of Intensive Care Medicine, Radboud University Medical Center, Nijmegen, The Netherlands.'}]",British journal of clinical pharmacology,['10.1111/bcp.13941'] 199,29332989,Art Therapy and Cognitive Processing Therapy for Combat-Related PTSD: A Randomized Controlled Trial.,"This randomized controlled trial was designed to determine if art therapy in conjunction with Cognitive Processing Therapy (CPT) was more effective for reducing symptoms of combat posttraumatic stress disorder (PTSD) than CPT alone. Veterans ( N = 11) were randomized to receive either individual CPT, or individual CPT in conjunction with individual art therapy. PTSD Checklist-Military Version and Beck Depression Inventory-II scores improved with treatment in both groups with no significant difference in improvement between the experimental and control groups. Art therapy in conjunction with CPT was found to improve trauma processing and veterans considered it to be an important part of their treatment as it provided healthy distancing, enhanced trauma recall, and increased access to emotions.",2016,PTSD Checklist-Military Version and Beck Depression Inventory-II scores improved with treatment in both groups with no significant difference in improvement between the experimental and control groups.,"['Veterans ( N = 11', 'Combat-Related PTSD']","['Cognitive Processing Therapy (CPT', 'individual CPT, or individual CPT in conjunction with individual art therapy', 'Art Therapy and Cognitive Processing Therapy']",['PTSD Checklist-Military Version and Beck Depression Inventory-II scores'],"[{'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4521399', 'cui_str': 'LT'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0003827', 'cui_str': 'Art Therapy'}]","[{'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0026126', 'cui_str': 'Armed Forces Personnel'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C4273555', 'cui_str': 'BDI-II (Beck Depression Inventory Second Edition) score'}]",11.0,0.0332411,PTSD Checklist-Military Version and Beck Depression Inventory-II scores improved with treatment in both groups with no significant difference in improvement between the experimental and control groups.,"[{'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Campbell', 'Affiliation': 'Art therapist at the University Neuro-psychiatric Institute, University of Utah, Salt Lake City.'}, {'ForeName': 'Kathleen P', 'Initials': 'KP', 'LastName': 'Decker', 'Affiliation': 'Staff psychiatrist at the Hampton VA Medical Center, Hampton, VA, and faculty member in the Department of Psychiatry at Eastern Virginia Medical School, Norfolk.'}, {'ForeName': 'Kerry', 'Initials': 'K', 'LastName': 'Kruk', 'Affiliation': 'Community faculty.'}, {'ForeName': 'Sarah P', 'Initials': 'SP', 'LastName': 'Deaver', 'Affiliation': 'Professor in the Graduate Art Therapy and Counseling Professions Program, Eastern Virginia Medical School.'}]",Art therapy : journal of the American Art Therapy Association,['10.1080/07421656.2016.1226643'] 200,31634898,A multipredictor model to predict the conversion of mild cognitive impairment to Alzheimer's disease by using a predictive nomogram.,"Predicting the probability of converting from mild cognitive impairment (MCI) to Alzheimer's disease (AD) is still a challenging task. This study aims at providing a personalized MCI-to-AD conversion estimation by using a multipredictor nomogram that integrates neuroimaging features, cerebrospinal fluid (CSF) biomarker, and clinical assessments. To do so, 290 MCI patients were collected from the Alzheimer's Disease Neuroimaging Initiative (ADNI), of whom 76 has converted to AD and 214 remained with MCI. All subjects were randomly divided into a primary and validation cohort. Radiomics signature (Rad-sig) was obtained based on 17 cerebral cortex features selected by using Least Absolute Shrinkage and Selection Operator (LASSO) algorithm. Clinical factors and amyloid-beta peptide (Aβ) concentration were selected by using Spearman correlation between the converted and not-converted patients. Then, a nomogram that combines image features, clinical factor, and Aβ concentration was constructed and validated. Furthermore, we explored the associations between various predictors from the macro- to the microperspective by assessing gene expression patterns. Our results showed that the multipredictor nomogram (C-index 0.978 and 0.956 in both cohorts, respectively) outperformed the nomogram using either Rad-sig or Aβ concentration as individual predictors. Significant associations were found between neuropsychological scores, cerebral cortex features, Aβ levels, and underlying gene pathways. Our study may have a clinical impact as a powerful predictive tool for predicting the conversion probability of MCI and providing associations between cognitive impairment, structural changes, Aβ levels, and underlying biological patterns from the macro- to the microperspective.",2020,"Significant associations were found between neuropsychological scores, cerebral cortex features, Aβ levels, and underlying gene pathways.","[""290 MCI patients were collected from the Alzheimer's Disease Neuroimaging Initiative (ADNI), of whom 76 has converted to AD and 214 remained with MCI""]",[],"['neuropsychological scores, cerebral cortex features, Aβ levels, and underlying gene pathways', 'Clinical factors and amyloid-beta peptide (Aβ) concentration']","[{'cui': 'C0560005', 'cui_str': 'millicurie'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0002395', 'cui_str': 'Alzheimer Dementia'}, {'cui': 'C0424093', 'cui_str': 'Initiative (observable entity)'}]",[],"[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0007776', 'cui_str': 'Cortical Plate'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0017337', 'cui_str': 'Genes'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0078939', 'cui_str': ""Alzheimer's ABP""}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",,0.0173736,"Significant associations were found between neuropsychological scores, cerebral cortex features, Aβ levels, and underlying gene pathways.","[{'ForeName': 'Kexin', 'Initials': 'K', 'LastName': 'Huang', 'Affiliation': ""School of Life Science and Technology, Xidian University, Xi'an, Shaanxi, 710071, P. R. China.""}, {'ForeName': 'Yanyan', 'Initials': 'Y', 'LastName': 'Lin', 'Affiliation': ""School of Life Science and Technology, Xidian University, Xi'an, Shaanxi, 710071, P. R. China.""}, {'ForeName': 'Lifeng', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': ""School of Life Science and Technology, Xidian University, Xi'an, Shaanxi, 710071, P. R. China.""}, {'ForeName': 'Yubo', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ""School of Life Science and Technology, Xidian University, Xi'an, Shaanxi, 710071, P. R. China.""}, {'ForeName': 'Suping', 'Initials': 'S', 'LastName': 'Cai', 'Affiliation': ""School of Life Science and Technology, Xidian University, Xi'an, Shaanxi, 710071, P. R. China.""}, {'ForeName': 'Liaojun', 'Initials': 'L', 'LastName': 'Pang', 'Affiliation': ""School of Life Science and Technology, Xidian University, Xi'an, Shaanxi, 710071, P. R. China.""}, {'ForeName': 'Xiaoming', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': ""The Key Laboratory of Biomedical Information Engineering of Ministry of Education, School of Life Sciences and Technology, Xi'an Jiaotong University, Xi'an, 710049, P. R. China.""}, {'ForeName': 'Liyu', 'Initials': 'L', 'LastName': 'Huang', 'Affiliation': ""School of Life Science and Technology, Xidian University, Xi'an, Shaanxi, 710071, P. R. China. huangly@mail.xidian.edu.cn.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0551-0'] 201,32324065,Efficacy and safety of ertugliflozin in Hispanic/Latino patients with type 2 diabetes mellitus.,"Objective: To assess the efficacy and safety of ertugliflozin in Hispanic/Latino patients with type 2 diabetes (T2DM). Methods: Analysis of data from Hispanic/Latino patients who participated in randomized, double-blind phase III studies. Ertugliflozin efficacy was evaluated when initiated as a single agent (as monotherapy or add-on therapy) and when initiated in combination with sitagliptin. Least-squares mean change from baseline was calculated for glycated hemoglobin (HbA1c), body weight (BW), and systolic blood pressure (SBP). Safety evaluation included overall and prespecified adverse events (AEs). Results: Analyses included 1178 Hispanic/Latino patients. In a pooled analysis of three placebo-controlled studies where ertugliflozin was initiated as a single agent, the placebo-corrected change from baseline in HbA1c at week 26 for ertugliflozin 5 and 15 mg was -0.8 and -1.0%, respectively. In an active-comparator study, when initiated as a single agent, the change from baseline in HbA1c at week 52 was -0.5, -0.7, and -0.5% for ertugliflozin 5 mg, ertugliflozin 15 mg, and glimepiride, respectively. In a placebo-controlled study, when initiated in combination with sitagliptin, the placebo-corrected change from baseline in HbA1c at week 26 for ertugliflozin 5 mg/sitagliptin and ertugliflozin 15 mg/sitagliptin was -1.3 and -1.6%, respectively. In an active-comparator study, when initiated in combination with sitagliptin, the change from baseline in HbA1c at week 26 was -1.4, -1.6, and -0.9 for ertugliflozin 5 mg/sitagliptin, ertugliflozin 15 mg/sitagliptin, and sitagliptin alone, respectively. Reductions in BW and SBP were observed with ertugliflozin as a single agent or combined with sitagliptin. The incidences of overall and prespecified AEs in Hispanic/Latino patients were generally consistent with the known safety profile of ertugliflozin. Conclusion: Ertugliflozin, administered as a single agent or as a combination with sitagliptin, improved HbA1c, BW, and SBP. Ertugliflozin was generally well-tolerated in Hispanic/Latino patients with T2DM. Clinicaltrials.gov identifiers: NCT01986855, NCT01999218, NCT01958671, NCT02099110, NCT02036515, NCT02033889, and NCT02226003.",2020,Reductions in BW and SBP were observed with ertugliflozin as a single agent or combined with sitagliptin.,"['1178 Hispanic/Latino patients', 'Hispanic/Latino patients with type 2 diabetes (T2DM', 'Hispanic/Latino patients with type 2 diabetes mellitus', 'Hispanic/Latino patients', 'Hispanic/Latino patients with T2DM', 'data from Hispanic/Latino patients who participated in randomized, double-blind phase III studies']","['placebo', 'Ertugliflozin', 'glimepiride', 'ertugliflozin']","['Ertugliflozin efficacy', 'efficacy and safety', 'HbA1c, BW, and SBP', 'glycated hemoglobin (HbA1c), body weight (BW), and systolic blood pressure (SBP', 'Reductions in BW and SBP', 'Efficacy and safety']","[{'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0086528', 'cui_str': 'Latinos'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}, {'cui': 'C0282461', 'cui_str': 'Clinical Trials, Phase 3 as Topic'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4079805', 'cui_str': 'ertugliflozin'}, {'cui': 'C0061323', 'cui_str': 'glimepiride'}]","[{'cui': 'C4079805', 'cui_str': 'ertugliflozin'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0085805', 'cui_str': 'Androgen Binding Protein'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",,0.084421,Reductions in BW and SBP were observed with ertugliflozin as a single agent or combined with sitagliptin.,"[{'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Merck & Co., Inc, Kenilworth, NJ, USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Tarasenko', 'Affiliation': 'Pfizer Inc., New York, NY, USA.'}, {'ForeName': 'Annpey', 'Initials': 'A', 'LastName': 'Pong', 'Affiliation': 'Merck & Co., Inc, Kenilworth, NJ, USA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Huyck', 'Affiliation': 'Merck & Co., Inc, Kenilworth, NJ, USA.'}, {'ForeName': 'Shrita', 'Initials': 'S', 'LastName': 'Patel', 'Affiliation': 'Merck & Co., Inc, Kenilworth, NJ, USA.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Hickman', 'Affiliation': 'Pfizer Inc., Groton, CT, USA.'}, {'ForeName': 'James P', 'Initials': 'JP', 'LastName': 'Mancuso', 'Affiliation': 'Pfizer Inc., Groton, CT, USA.'}, {'ForeName': 'Misoo C', 'Initials': 'MC', 'LastName': 'Ellison', 'Affiliation': 'Merck & Co., Inc, Kenilworth, NJ, USA.'}, {'ForeName': 'Ira', 'Initials': 'I', 'LastName': 'Gantz', 'Affiliation': 'Merck & Co., Inc, Kenilworth, NJ, USA.'}, {'ForeName': 'Steven G', 'Initials': 'SG', 'LastName': 'Terra', 'Affiliation': 'Pfizer Inc., Andover, MA, USA.'}]",Current medical research and opinion,['10.1080/03007995.2020.1760227'] 202,32120018,Single dose testosterone administration increases men's facial femininity preference in a Chinese population.,"Sex hormones are thought to influence human mate preferences. Previous studies have reported mixed results regarding the association between men's testosterone levels and their mate preferences. The present study investigated the effect of testosterone administration on men's facial femininity preference. Heterosexual Chinese male participants (n = 140) received a single dose of 150 mg testosterone or placebo gel in a double-blind, placebo-controlled, between-participant design. Results showed that Chinese men demonstrated general preferences for feminized women's faces, consistent with previous results from the Western population. More importantly, men showed stronger attraction to femininity in women's faces three hours after testosterone administration than at the beginning of the session. In the placebo group, no significant change in facial femininity preferences was found between time points. These results indicate that exogenous testosterone increases men's facial femininity preferences in a Chinese population.",2020,"In the placebo group, no significant change in facial femininity preferences was found between time points.","[""men's facial femininity preference in a Chinese population"", 'Heterosexual Chinese male participants (n = 140', ""men's facial femininity preference""]","['placebo', 'exogenous testosterone', 'testosterone or placebo gel', 'testosterone']","['general preferences', 'facial femininity preferences']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0233894', 'cui_str': 'Femininity'}, {'cui': 'C0558295', 'cui_str': 'Preferences (qualifier value)'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C1527360', 'cui_str': 'Heterosexuals'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0205228', 'cui_str': 'Exogenous (qualifier value)'}, {'cui': 'C0523912', 'cui_str': 'Testosterone measurement (procedure)'}, {'cui': 'C0017243', 'cui_str': 'Gel (basic dose form)'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0233894', 'cui_str': 'Femininity'}, {'cui': 'C0558295', 'cui_str': 'Preferences (qualifier value)'}]",,0.332003,"In the placebo group, no significant change in facial femininity preferences was found between time points.","[{'ForeName': 'Chengyang', 'Initials': 'C', 'LastName': 'Han', 'Affiliation': 'Shenzhen Key Laboratory of Affective and Social Cognitive Science, Shenzhen University, Shenzhen, China; School of Psychology, Shenzhen University, Shenzhen, China.'}, {'ForeName': 'Yinhua', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Shenzhen Key Laboratory of Affective and Social Cognitive Science, Shenzhen University, Shenzhen, China; School of Psychology, Shenzhen University, Shenzhen, China.'}, {'ForeName': 'Xue', 'Initials': 'X', 'LastName': 'Lei', 'Affiliation': 'School of Psychology & Neuroscience, University of St Andrews, St Andrews, United Kingdom.'}, {'ForeName': 'Xiangqian', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Department of Psychology, School of Social Development and Public Policy, Fudan University, Shanghai, China.'}, {'ForeName': 'Edward R', 'Initials': 'ER', 'LastName': 'Morrison', 'Affiliation': 'Centre for Comparative and Evolutionary Psychology, University of Portsmouth, Portsmouth, UK.'}, {'ForeName': 'Yin', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'Shenzhen Key Laboratory of Affective and Social Cognitive Science, Shenzhen University, Shenzhen, China; School of Psychology, Shenzhen University, Shenzhen, China. Electronic address: yinwu0407@gmail.com.'}]",Psychoneuroendocrinology,['10.1016/j.psyneuen.2020.104630'] 203,28054910,Examining Effects of Physical Exertion on the Dynamic Visual Acuity Test in Collegiate Athletes.,"BACKGROUND Acute symptoms of dizziness and/or imbalance commonly experienced in athletes postconcussion are speculated to arise from dysfunction at multiple levels (i.e., inner ear or central vestibular system) to appropriately integrate afferent sensory information. Disruption along any pathway of the balance system can result in symptoms of dizziness, decreased postural control function (vestibulospinal reflex), and reduced vestibulo-ocular reflex function. This may also lead to decreased gaze stability with movements of the head and may account for symptoms of blurred vision or diplopia reported in almost half of athletes sustaining a concussion. Current concussion position statements include measures of postural control to examine changes to the balance system postconcussion. The Balance Error Scoring System (BESS) is a commonly used low-cost postural control measure for concussion assessment. Although this is a widely used measure for documenting balance function on both immediate (sideline) and recovery monitoring, the BESS has been shown to be affected by physical exertion. Therefore, the BESS may not be the most efficient means of examining functional changes to the balance system immediately after head injury. Dynamic Visual Acuity Test (DVAT) has been found to effectively evaluate and monitor changes to the gaze stability system postinjury. Thus, DVAT may be an additional measure in the concussion assessment battery, as well as an alternative for more immediate sideline assessment to help make objective return-to-play decisions. PURPOSE The aim of the study was to determine the effects of physical exertion on a clinical vestibular assessment, the DVAT, in collegiate athletes, as a first step in defining the role of this measure in the concussion assessment battery. RESEARCH DESIGN Cross-sectional, repeated-measures design. STUDY SAMPLE Twenty-eight healthy collegiate athletes (20 males, 8 females; age = 20.25 ± 1.46 yr, range = 18-25 yr) volunteered to participate in the study. DATA COLLECTION AND ANALYSIS Participants were randomly assigned to complete a 20-min protocol of physical exertion or rest. DVAT was completed pre-exertion or rest (pre-DVAT), immediately following the 20-min protocol (post-DVAT I), and again 10 min after the completion of the 20-min protocol (post-DVAT II). Ratings of perceived exertion (RPE) and heart rate (HR) were monitored throughout testing. Repeated-measures analysis of the variance were used to examine the effects of exertion on DVAT. Additionally, intraclass correlation coefficients were used to examine test reliability. RESULTS No significant main effect was observed for right and left DVAT logarithm of the minimal angle of resolution loss between groups or across time points (p > 0.05). A significant main effect was observed for RPE and HR for groups and time points (p < 0.001), indicating adequate physical exertion and rest. Fair to good reliability (intraclass correlation coefficient values between 0.4 and 0.74) was observed for both rightward and leftward movements of the head across the three time points. CONCLUSIONS Findings from this study suggest that DVAT is not affected by physical exertion and may provide a more immediate assessment of the balance system that may be of use for the sideline concussion assessment. Future studies will be performed to examine additional factors (e.g., background noise, complex visual backgrounds) that may affect DVAT performance in the sideline environment.",2017,No significant main effect was observed for right and left DVAT logarithm of the minimal angle of resolution loss between groups or across time points (p > 0.05).,"['SAMPLE\n\n\nTwenty-eight healthy collegiate athletes (20 males, 8 females; age = 20.25 ± 1.46', 'yr, range = 18-25 yr) volunteered to participate in the study', 'Collegiate Athletes']","['physical exertion', 'Dynamic Visual Acuity Test (DVAT', 'Physical Exertion', 'DVAT', '20-min protocol of physical exertion or rest']","['postural control function (vestibulospinal reflex), and reduced vestibulo-ocular reflex function', 'Ratings of perceived exertion (RPE) and heart rate (HR', 'Dynamic Visual Acuity Test', 'adequate physical exertion and rest', 'right and left DVAT logarithm of the minimal angle of resolution loss', 'gaze stability']","[{'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0031807', 'cui_str': 'Physical Effort'}, {'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C0200150', 'cui_str': 'Visual acuity testing (procedure)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0035253', 'cui_str': 'Rest'}]","[{'cui': 'C0205278', 'cui_str': 'Postural (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0034929', 'cui_str': 'Reflex'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0034944', 'cui_str': 'Reflexes, Vestibo-Ocular'}, {'cui': 'C0015264', 'cui_str': 'Exertion, function (observable entity)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C0200150', 'cui_str': 'Visual acuity testing (procedure)'}, {'cui': 'C0205411', 'cui_str': 'Adequate (qualifier value)'}, {'cui': 'C0031807', 'cui_str': 'Physical Effort'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0547040', 'cui_str': 'Minimal (qualifier value)'}, {'cui': 'C0205143', 'cui_str': 'Angular (qualifier value)'}, {'cui': 'C0553544', 'cui_str': 'Gaze (finding)'}]",28.0,0.0394736,No significant main effect was observed for right and left DVAT logarithm of the minimal angle of resolution loss between groups or across time points (p > 0.05).,"[{'ForeName': 'Jessie N', 'Initials': 'JN', 'LastName': 'Patterson', 'Affiliation': 'Department of Special Education and Communication Disorders, University of Nebraska-Lincoln, Lincoln, NE.'}, {'ForeName': 'Anna M', 'Initials': 'AM', 'LastName': 'Murphy', 'Affiliation': 'Department of Special Education and Communication Disorders, University of Nebraska-Lincoln, Lincoln, NE.'}, {'ForeName': 'Julie A', 'Initials': 'JA', 'LastName': 'Honaker', 'Affiliation': 'Department of Special Education and Communication Disorders, University of Nebraska-Lincoln, Lincoln, NE.'}]",Journal of the American Academy of Audiology,['10.3766/jaaa.15110'] 204,31995812,Evaluating global brain connectivity as an imaging marker for depression: influence of preprocessing strategies and placebo-controlled ketamine treatment.,"Major depressive disorder (MDD) is associated with altered global brain connectivity (GBC), as assessed via resting-state functional magnetic resonance imaging (rsfMRI). Previous studies found that antidepressant treatment with ketamine normalized aberrant GBC changes in the prefrontal and cingulate cortices, warranting further investigations of GBC as a putative imaging marker. These results were obtained via global signal regression (GSR). This study is an independent replication of that analysis using a separate dataset. GBC was analyzed in 28 individuals with MDD and 22 healthy controls (HCs) at baseline, post-placebo, and post-ketamine. To investigate the effects of preprocessing, three distinct pipelines were used: (1) regression of white matter (WM)/cerebrospinal fluid (CSF) signals only (BASE); (2) WM/CSF + GSR (GSR); and (3) WM/CSF + physiological parameter regression (PHYSIO). Reduced GBC was observed in individuals with MDD only at baseline in the anterior and medial cingulate cortices, as well as in the prefrontal cortex only after regressing the global signal. Ketamine had no effect compared to baseline or placebo in either group in any pipeline. PHYSIO did not resemble GBC preprocessed with GSR. These results concur with several studies that used GSR to study GBC. Further investigations are warranted into disease-specific components of global fMRI signals that may drive these results and of GBCr as a potential imaging marker in MDD.",2020,"Reduced GBC was observed in individuals with MDD only at baseline in the anterior and medial cingulate cortices, as well as in the prefrontal cortex only after regressing the global signal.","['Major depressive disorder (MDD', '28 individuals with MDD and 22 healthy controls (HCs) at baseline, post']","['placebo', 'Ketamine', 'placebo-controlled ketamine', 'ketamine', 'white matter (WM)/cerebrospinal fluid (CSF) signals only (BASE); (2) WM/CSF\u2009+\u2009GSR (GSR); and (3) WM/CSF\u2009+\u2009physiological parameter regression (PHYSIO']","['GBC', 'Reduced GBC']","[{'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0682708'}, {'cui': 'C0444611', 'cui_str': 'Fluid - descriptor'}, {'cui': 'C0205463', 'cui_str': 'Physiologic (qualifier value)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0684321', 'cui_str': 'Regression'}]","[{'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}]",28.0,0.0521611,"Reduced GBC was observed in individuals with MDD only at baseline in the anterior and medial cingulate cortices, as well as in the prefrontal cortex only after regressing the global signal.","[{'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Kraus', 'Affiliation': 'Section on the Neurobiology and Treatment of Mood Disorders, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA. christoph.kraus@nih.gov.'}, {'ForeName': 'Anahit', 'Initials': 'A', 'LastName': 'Mkrtchian', 'Affiliation': 'Section on the Neurobiology and Treatment of Mood Disorders, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Bashkim', 'Initials': 'B', 'LastName': 'Kadriu', 'Affiliation': 'Section on the Neurobiology and Treatment of Mood Disorders, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Allison C', 'Initials': 'AC', 'LastName': 'Nugent', 'Affiliation': 'Section on the Neurobiology and Treatment of Mood Disorders, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Carlos A', 'Initials': 'CA', 'LastName': 'Zarate', 'Affiliation': 'Section on the Neurobiology and Treatment of Mood Disorders, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Jennifer W', 'Initials': 'JW', 'LastName': 'Evans', 'Affiliation': 'Section on the Neurobiology and Treatment of Mood Disorders, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-020-0624-0'] 205,31995813,"Modafinil enhances cognitive, but not emotional conflict processing via enhanced inferior frontal gyrus activation and its communication with the dorsomedial prefrontal cortex.","Cognitive control regulates cognitive and emotional systems to facilitate goal-directed behavior in the context of task-irrelevant distractors. Cognitive control deficits contribute to residual functional impairments across psychiatric disorders and represent a promising novel treatment target. Translational evidence suggests that modafinil may enhance performance in executive functions; however, differential effects on regulatory control in cognitive and emotional domains have not been examined. The present pre-registered randomized-controlled pharmacological fMRI trial examined differential effects of modafinil (single-dose, 200 mg) on cognitive and emotional conflict processing. To further separate objective cognitive enhancing effects from subjective performance perception, a metacognitive paradigm was employed. Results indicated that modafinil specifically enhanced cognitive conflict performance and concomitantly increased activation in the inferior frontal gyrus and its functional communication with the dorsomedial prefrontal cortex. Exploratory analysis further revealed modafinil-enhanced basolateral amygdala reactivity to cognitive conflict, with stronger reactivity being associated with higher cognitive conflict performance. Whereas modafinil enhanced cognitive performance in the metacognitive paradigm, confidence indices remained unaffected. Overall, the present results suggest that modafinil has the potential to enhance cognitive conflict processing while leaving emotional conflict processing unaffected. On the neural level modafinil enhanced the recruitment of a network engaged in general conflict and regulatory control processes, whereas effects on the amygdala may reflect improved arousal-mediated attention processes for conflicting information. The pattern of cognitive enhancing effects in the absence of effects on affective processing suggests a promising potential to enhance cognitive control in clinical populations.",2020,"On the neural level modafinil enhanced the recruitment of a network engaged in general conflict and regulatory control processes, whereas effects on the amygdala may reflect improved arousal-mediated attention processes for conflicting information.",[],"['Modafinil', 'modafinil']","['cognitive performance', 'cognitive and emotional conflict processing', 'cognitive conflict performance']",[],"[{'cui': 'C0066677', 'cui_str': 'modafinil'}]","[{'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0009671', 'cui_str': 'Conflict'}]",,0.0288783,"On the neural level modafinil enhanced the recruitment of a network engaged in general conflict and regulatory control processes, whereas effects on the amygdala may reflect improved arousal-mediated attention processes for conflicting information.","[{'ForeName': 'Jialin', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'The Clinical Hospital of the Chengdu Brain Science Institute, MOE Key Laboratory for Neuroinformation, University of Electronic Science and Technology of China, Chengdu, China.'}, {'ForeName': 'Xi', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': 'The Clinical Hospital of the Chengdu Brain Science Institute, MOE Key Laboratory for Neuroinformation, University of Electronic Science and Technology of China, Chengdu, China.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Zhou', 'Affiliation': 'The Clinical Hospital of the Chengdu Brain Science Institute, MOE Key Laboratory for Neuroinformation, University of Electronic Science and Technology of China, Chengdu, China.'}, {'ForeName': 'Congcong', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': 'The Clinical Hospital of the Chengdu Brain Science Institute, MOE Key Laboratory for Neuroinformation, University of Electronic Science and Technology of China, Chengdu, China.'}, {'ForeName': 'Zhenyu', 'Initials': 'Z', 'LastName': 'Wei', 'Affiliation': 'The Clinical Hospital of the Chengdu Brain Science Institute, MOE Key Laboratory for Neuroinformation, University of Electronic Science and Technology of China, Chengdu, China.'}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Xin', 'Affiliation': 'The Clinical Hospital of the Chengdu Brain Science Institute, MOE Key Laboratory for Neuroinformation, University of Electronic Science and Technology of China, Chengdu, China.'}, {'ForeName': 'Bianca', 'Initials': 'B', 'LastName': 'Daumann', 'Affiliation': 'LVR Clinics of Cologne, Cologne, Germany.'}, {'ForeName': 'Jörg', 'Initials': 'J', 'LastName': 'Daumann', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Keith M', 'Initials': 'KM', 'LastName': 'Kendrick', 'Affiliation': 'The Clinical Hospital of the Chengdu Brain Science Institute, MOE Key Laboratory for Neuroinformation, University of Electronic Science and Technology of China, Chengdu, China.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Becker', 'Affiliation': 'The Clinical Hospital of the Chengdu Brain Science Institute, MOE Key Laboratory for Neuroinformation, University of Electronic Science and Technology of China, Chengdu, China. ben_becker@gmx.de.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-020-0625-z'] 206,32321387,Improved Glycemic Control in Adults With Serious Mental Illness and Diabetes With a Behavioral and Educational Intervention.,"OBJECTIVE The purpose of this study was to evaluate a 16-week, reverse-integrated care (bringing primary care interventions/services into the psychiatric setting) behavioral and educational group intervention for individuals with serious mental illness and diabetes. METHODS The primary outcome was change in glycated hemoglobin (HbA1c). Secondary outcomes included body mass index (BMI), blood pressure, lipid levels, physical activity, diabetes knowledge, and self-care. RESULTS Thirty-five participants attended at least one group and were included in a modified intent-to-treat analysis. From baseline to week 16, HbA1c improved, from 7.5±1.6 to 7.1±1.4, p=0.01, and BMI improved, from 33.3±3.8 to 32.9±4.1, p<0.001, as did measures of diabetes knowledge and self-care. One-year follow-up in a subset of participants showed no evidence of rebound in HbA1c. CONCLUSIONS This 16-week behavioral and educational group intervention resulted in improvements in glycemic control, BMI, diabetes knowledge, and self-care. The results warrant larger-scale, controlled trial testing of this intervention to improve diabetes-related health outcomes in those with serious mental illness.",2020,"From baseline to week 16, HbA1c improved, from 7.5±1.6 to 7.1±1.4, p=0.01, and BMI improved, from 33.3±3.8 to 32.9±4.1, p<0.001, as did measures of diabetes knowledge and self-care.","['Adults With Serious Mental Illness and Diabetes With a Behavioral and Educational Intervention', 'individuals with serious mental illness and diabetes']","['behavioral and educational group intervention', 'reverse-integrated care (bringing primary care interventions/services into the psychiatric setting) behavioral and educational group intervention']","['diabetes knowledge and self-care', 'glycated hemoglobin (HbA1c', 'BMI', 'body mass index (BMI), blood pressure, lipid levels, physical activity, diabetes knowledge, and self-care', 'glycemic control, BMI, diabetes knowledge, and self-care']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332302', 'cui_str': 'Brought on by'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}]","[{'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0036592', 'cui_str': 'Self-care interventions'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0428460', 'cui_str': 'Lipid level - finding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",35.0,0.0533,"From baseline to week 16, HbA1c improved, from 7.5±1.6 to 7.1±1.4, p=0.01, and BMI improved, from 33.3±3.8 to 32.9±4.1, p<0.001, as did measures of diabetes knowledge and self-care.","[{'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Schnitzer', 'Affiliation': 'Center for Addiction Medicine, Department of Psychiatry (Schnitzer, Cather, Vilme, Dechert, Evins), Schizophrenia Research Program (Schnitzer, Cather, Freudenreich, MacLaurin, Vilme, Dechert, Evins), Diabetes Center, Department of Medicine (Wexler) and General Medicine Division, Department of Medicine (Thorndike), Department of Biostatistics (Potter), all at Massachusetts General Hospital (MGH), Boston; Erich Lindemann Mental Health Center, Freedom Trail Clinic, Boston (Freudenreich, MacLaurin).'}, {'ForeName': 'Corrine', 'Initials': 'C', 'LastName': 'Cather', 'Affiliation': 'Center for Addiction Medicine, Department of Psychiatry (Schnitzer, Cather, Vilme, Dechert, Evins), Schizophrenia Research Program (Schnitzer, Cather, Freudenreich, MacLaurin, Vilme, Dechert, Evins), Diabetes Center, Department of Medicine (Wexler) and General Medicine Division, Department of Medicine (Thorndike), Department of Biostatistics (Potter), all at Massachusetts General Hospital (MGH), Boston; Erich Lindemann Mental Health Center, Freedom Trail Clinic, Boston (Freudenreich, MacLaurin).'}, {'ForeName': 'Anne N', 'Initials': 'AN', 'LastName': 'Thorndike', 'Affiliation': 'Center for Addiction Medicine, Department of Psychiatry (Schnitzer, Cather, Vilme, Dechert, Evins), Schizophrenia Research Program (Schnitzer, Cather, Freudenreich, MacLaurin, Vilme, Dechert, Evins), Diabetes Center, Department of Medicine (Wexler) and General Medicine Division, Department of Medicine (Thorndike), Department of Biostatistics (Potter), all at Massachusetts General Hospital (MGH), Boston; Erich Lindemann Mental Health Center, Freedom Trail Clinic, Boston (Freudenreich, MacLaurin).'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Potter', 'Affiliation': 'Center for Addiction Medicine, Department of Psychiatry (Schnitzer, Cather, Vilme, Dechert, Evins), Schizophrenia Research Program (Schnitzer, Cather, Freudenreich, MacLaurin, Vilme, Dechert, Evins), Diabetes Center, Department of Medicine (Wexler) and General Medicine Division, Department of Medicine (Thorndike), Department of Biostatistics (Potter), all at Massachusetts General Hospital (MGH), Boston; Erich Lindemann Mental Health Center, Freedom Trail Clinic, Boston (Freudenreich, MacLaurin).'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Freudenreich', 'Affiliation': 'Center for Addiction Medicine, Department of Psychiatry (Schnitzer, Cather, Vilme, Dechert, Evins), Schizophrenia Research Program (Schnitzer, Cather, Freudenreich, MacLaurin, Vilme, Dechert, Evins), Diabetes Center, Department of Medicine (Wexler) and General Medicine Division, Department of Medicine (Thorndike), Department of Biostatistics (Potter), all at Massachusetts General Hospital (MGH), Boston; Erich Lindemann Mental Health Center, Freedom Trail Clinic, Boston (Freudenreich, MacLaurin).'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'MacLaurin', 'Affiliation': 'Center for Addiction Medicine, Department of Psychiatry (Schnitzer, Cather, Vilme, Dechert, Evins), Schizophrenia Research Program (Schnitzer, Cather, Freudenreich, MacLaurin, Vilme, Dechert, Evins), Diabetes Center, Department of Medicine (Wexler) and General Medicine Division, Department of Medicine (Thorndike), Department of Biostatistics (Potter), all at Massachusetts General Hospital (MGH), Boston; Erich Lindemann Mental Health Center, Freedom Trail Clinic, Boston (Freudenreich, MacLaurin).'}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Vilme', 'Affiliation': 'Center for Addiction Medicine, Department of Psychiatry (Schnitzer, Cather, Vilme, Dechert, Evins), Schizophrenia Research Program (Schnitzer, Cather, Freudenreich, MacLaurin, Vilme, Dechert, Evins), Diabetes Center, Department of Medicine (Wexler) and General Medicine Division, Department of Medicine (Thorndike), Department of Biostatistics (Potter), all at Massachusetts General Hospital (MGH), Boston; Erich Lindemann Mental Health Center, Freedom Trail Clinic, Boston (Freudenreich, MacLaurin).'}, {'ForeName': 'Alyson', 'Initials': 'A', 'LastName': 'Dechert', 'Affiliation': 'Center for Addiction Medicine, Department of Psychiatry (Schnitzer, Cather, Vilme, Dechert, Evins), Schizophrenia Research Program (Schnitzer, Cather, Freudenreich, MacLaurin, Vilme, Dechert, Evins), Diabetes Center, Department of Medicine (Wexler) and General Medicine Division, Department of Medicine (Thorndike), Department of Biostatistics (Potter), all at Massachusetts General Hospital (MGH), Boston; Erich Lindemann Mental Health Center, Freedom Trail Clinic, Boston (Freudenreich, MacLaurin).'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Wexler', 'Affiliation': 'Center for Addiction Medicine, Department of Psychiatry (Schnitzer, Cather, Vilme, Dechert, Evins), Schizophrenia Research Program (Schnitzer, Cather, Freudenreich, MacLaurin, Vilme, Dechert, Evins), Diabetes Center, Department of Medicine (Wexler) and General Medicine Division, Department of Medicine (Thorndike), Department of Biostatistics (Potter), all at Massachusetts General Hospital (MGH), Boston; Erich Lindemann Mental Health Center, Freedom Trail Clinic, Boston (Freudenreich, MacLaurin).'}, {'ForeName': 'Anne Eden', 'Initials': 'AE', 'LastName': 'Evins', 'Affiliation': 'Center for Addiction Medicine, Department of Psychiatry (Schnitzer, Cather, Vilme, Dechert, Evins), Schizophrenia Research Program (Schnitzer, Cather, Freudenreich, MacLaurin, Vilme, Dechert, Evins), Diabetes Center, Department of Medicine (Wexler) and General Medicine Division, Department of Medicine (Thorndike), Department of Biostatistics (Potter), all at Massachusetts General Hospital (MGH), Boston; Erich Lindemann Mental Health Center, Freedom Trail Clinic, Boston (Freudenreich, MacLaurin).'}]","Psychiatric services (Washington, D.C.)",['10.1176/appi.ps.201900336'] 207,32060099,"Routine-Dose and High-Dose Icotinib in Patients with Advanced Non-Small Cell Lung Cancer Harboring EGFR Exon 21-L858R Mutation: the Randomized, Phase II, INCREASE Trial.","PURPOSE Our primary purpose is to explore safety and efficacy of high-dose icotinib in comparison with routine-dose icotinib in patients with non-small cell lung cancer (NSCLC) harboring 21-L858R mutation. PATIENTS AND METHODS Patients with treatment-naïve, EGFR-mutant (21-L858R or exon 19 deletion at 2:1) NSCLC were enrolled. Patients with 21-L858R mutation were randomized to receive routine-dose icotinib (125 mg, thrice daily; L858R-RD) or high-dose icotinib (250 mg, thrice daily; L858R-HD), whereas patients with exon 19 deletion received only routine-dose icotinib (19-Del-RD) until progression, death, or unacceptable toxicity. The primary endpoint was median progression-free survival (mPFS), assessed by an independent review committee. RESULTS From May 2015 to November 2017, 253 patients (86 in L858R-RD; 90 in L858R-HD; and 77 in 19-Del-RD) were enrolled. The mPFS in L858R-HD group was similar to that in 19-Del-RD group (12.9 months and 12.5 months, respectively) and was significantly longer than that in L858R-RD group [12.9 months vs. 9.2 months, hazard ratio (HR): 0.75; 95% confidence interval (CI), 0.53-1.05]. A longer but statistically nonsignificant mPFS was observed between 19-Del-RD and L858R-RD groups (12.5 months vs. 9.2 months, HR: 0.80; 95% CI, 0.57-1.13). A higher objective response rate (ORR) was observed in L858R-HD group compared with L858R-RD group (73% vs. 48%), also between 19-Del-RD and L858R-RD groups (75% vs. 48%). Similar incidences of grade 3/4 toxicities were observed among the three treatment groups. CONCLUSIONS High-dose icotinib improved mPFS and ORR in patients with NSCLC harboring 21-L858R mutation with acceptable tolerability, which could be a new therapeutic option for this patient population.",2020,"A longer but statistically non-significant mPFS was observed between 19-Del-RD and L858R-RD groups (12.5 months vs. 9.2 months, HR: 0.80; 95% CI: 0.57 to 1.13).","['Patients with 21-L858R mutation', '253 patients (86 in L858R-RD; 90 in L858R-HD; 77 in 19-Del-RD) were enrolled', 'Treatment-naïve, EGFR-mutant ', 'Advanced Non-Small Cell Lung Cancer Patients harboring EGFR', 'NSCLC patients were enrolled', 'non-small cell lung cancer (NSCLC) patients harboring 21-L858R mutation', 'NSCLC patients harboring 21-L858R mutation']","['routine-dose icotinib', 'Routine-dose and High-dose Icotinib']","['median progression-free survival (mPFS), assessed by an independent review committee (IRC', 'grade 3/4 toxicities', 'objective response rate (ORR', 'mPFS and ORR']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0026882', 'cui_str': 'Mutation'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}, {'cui': 'C0475311', 'cui_str': 'Harbor (environment)'}]","[{'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C2604307', 'cui_str': '4-((3-ethynylphenyl)amino)-6,7-benzo-12-crown-4-quinazoline'}, {'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0949759', 'cui_str': 'Review Committees'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0442757', 'cui_str': '3/4'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}]",,0.100607,"A longer but statistically non-significant mPFS was observed between 19-Del-RD and L858R-RD groups (12.5 months vs. 9.2 months, HR: 0.80; 95% CI: 0.57 to 1.13).","[{'ForeName': 'Xi', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Department of Medical Oncology, Beijing Chest Hospital, Capital Medical University, Beijing Tuberculosis and Thoracic Tumor Research Institute, Beijing, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Respiratory Medicine, Chinese Academy of Medical Sciences & Peking Union Medical College Hospital, Beijing, China.'}, {'ForeName': 'Da', 'Initials': 'D', 'LastName': 'Jiang', 'Affiliation': 'Department of Medical Oncology, The Forth Hospital of Hebei Medical University, Tumor Hospital of Hebei Province, Shijiazhuang, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'State Key Laboratory of Molecular Oncology, Department of Medical Oncology, National Cancer Center and Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Aimin', 'Initials': 'A', 'LastName': 'Zang', 'Affiliation': 'Hebei Key Laboratory of Cancer Radiotherapy and Chemotherapy, Department of Medical Oncology, Affiliated Hospital of Hebei University, Baoding, China.'}, {'ForeName': 'Cuimin', 'Initials': 'C', 'LastName': 'Ding', 'Affiliation': 'Department of Respiratory Medicine, The Fourth Hospital of Hebei Medical University, Shijiazhuang, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Zhao', 'Affiliation': 'Department of Oncology, Hebei Chest Hospital, Shijiazhuang, Hebei, China.'}, {'ForeName': 'Wuyun', 'Initials': 'W', 'LastName': 'Su', 'Affiliation': 'Department of Medical Oncology, The Affiliated Hospital of Inner Mongolia Medical University, Hohhot, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': ""Department of Oncology, Affiliated People's Hospital of Hebei Medical University, Shijiazhuang, China.""}, {'ForeName': 'Diansheng', 'Initials': 'D', 'LastName': 'Zhong', 'Affiliation': 'Department of Oncology, Tianjin Medical University General Hospital, Tianjin, China.'}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'Department of Head and Neck and Genito-Urinary Oncology, Harbin Medical University Cancer Hospital, Harbin, China.'}, {'ForeName': 'Cuiying', 'Initials': 'C', 'LastName': 'Zhang', 'Affiliation': ""Department of Medical Oncology, People's Hospital of Inner Mongolia Autonomous Region, Hohhot, China.""}, {'ForeName': 'Guangyu', 'Initials': 'G', 'LastName': 'An', 'Affiliation': 'Department of Medical Oncology, Beijing Chao-Yang Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Xingsheng', 'Initials': 'X', 'LastName': 'Hu', 'Affiliation': 'State Key Laboratory of Molecular Oncology, Department of Medical Oncology, National Cancer Center and Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Cheng', 'Affiliation': 'Department of Oncology, Beijing Hospital, National Center of Gerontology, Beijing, China.'}, {'ForeName': 'Huaqing', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': ""Department of Respiratory Medicine, Tianjin People's Hospital, Tianjin, China.""}, {'ForeName': 'Yongqun', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Respiratory Department, Sixth Medical Center of PLA General Hospital, Beijing, China.'}, {'ForeName': 'Xiaohui', 'Initials': 'X', 'LastName': 'He', 'Affiliation': 'State Key Laboratory of Molecular Oncology, Department of Medical Oncology, National Cancer Center and Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Junli', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': ""Department of Medical Oncology, Xingtai People's Hospital of Hebei Medical University, Xingtai, China.""}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Liang', 'Affiliation': 'Department of Oncology, Peking University Third Hospital, Beijing, China.'}, {'ForeName': 'Lieming', 'Initials': 'L', 'LastName': 'Ding', 'Affiliation': 'Betta Pharmaceutical Co., Ltd., Hangzhou, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Mao', 'Affiliation': 'Betta Pharmaceutical Co., Ltd., Hangzhou, China.'}, {'ForeName': 'Shucai', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': 'Department of Medical Oncology, Beijing Chest Hospital, Capital Medical University, Beijing Tuberculosis and Thoracic Tumor Research Institute, Beijing, China. sczhang6304@163.com.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-19-3064'] 208,32312147,Nomogram for predicting overall survival of patients with bladder cancer: A population-based study.,"OBJECTIVE The aim of this study was to develop and validate a reliable nomogram to estimate overall survival in bladder cancer. METHOD Patients diagnosed with bladder cancer identified in the Surveillance, Epidemiology, and End Results database were randomly divided into training and validation cohorts. The powerful prognostic variables were examined using Cox regression analyses. A nomogram was developed on the prognostic factors. RESULTS The results suggested that age, sex, race, grade, histologic type, primary site, pathological stage, surgical treatment, and number of primary tumors, were the powerful prognostic factors. All these factors were integrated to construct the nomogram. The nomogram for predicting overall survival showed better discrimination power than the tumor-node-metastasis (TNM) stage system 8th edition. CONCLUSION The nomogram has the potential to provide an individualized prediction of overall survival in patients with bladder cancer.",2020,"The nomogram for predicting overall survival showed better discrimination power than the tumor-node-metastasis (TNM) stage system 8th edition. ","['Patients diagnosed with bladder cancer identified in the Surveillance, Epidemiology, and End Results database', 'patients with bladder cancer']",[],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0005684', 'cui_str': 'Malignant tumor of urinary bladder'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0220920', 'cui_str': 'surveillance'}, {'cui': 'C0014507', 'cui_str': 'Epidemiology'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}]",[],[],,0.0463231,"The nomogram for predicting overall survival showed better discrimination power than the tumor-node-metastasis (TNM) stage system 8th edition. ","[{'ForeName': 'Jiawu', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Urology, the First Affiliated Hospital of Chongqing Medical University, Yuzhong District, Chongqing, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'Department of General Surgery, University-town Hospital of Chongqing Medical University, Shapingba District, Chongqing, China.'}, {'ForeName': 'Weiyang', 'Initials': 'W', 'LastName': 'He', 'Affiliation': 'Department of Urology, the First Affiliated Hospital of Chongqing Medical University, Yuzhong District, Chongqing, China.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Yang', 'Affiliation': 'Department of Urology, The General Hospital of Chongqing Steel Company, Chongqing, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Gou', 'Affiliation': 'Department of Urology, the First Affiliated Hospital of Chongqing Medical University, Yuzhong District, Chongqing, China.'}]",The International journal of biological markers,['10.1177/1724600820907605'] 209,32312562,Predicting the outcome of respiratory disease in wheezing infants using tidal flow-volume loop shape.,"INTRODUCTION AND OBJECTIVES Wheezing (RW) infants with a positive asthma predictive index (API+) have a lower lung function as measured by forced expiratory techniques. Tidal flow-volume loops (TFVL) are easy to perform in infants, and sedation is not necessary. MATERIALS AND METHODS A total of 216 wheezing infants were successfully measured, and 183 of them were followed for over a year. TFVL loops were classified into one of three categories depending of their geometric shape (symmetric, convex, and concave). Respiratory rate (Rr), presence of API+, and the number of exacerbations during the following year were also recorded. RESULTS Children with concave loops had more exacerbations in the following year (OR = 6.8 [IC95% 3.33;13.91]). Infants API + were also significantly more related to concave loops (OR = 10.02 [IC 95% 4.53; 22.15]). Rr was higher in infants with concave loops (44+/-15.5 vs. 36.6 +/-12.6; p < 0.01). CONCLUSION Infants with a concave TFVL have a higher probability of experiencing exacerbations in the following year, and are at a higher risk of suffering asthma.",2020,Infants API + were also significantly more related to concave loops (OR = 10.02,"['216 wheezing infants', 'Wheezing (RW) infants with a positive asthma predictive index (API']",['Tidal flow-volume loops (TFVL'],"['probability of experiencing exacerbations', 'Respiratory rate (Rr), presence of API+, and the number of exacerbations', 'exacerbations']","[{'cui': 'C4708905', 'cui_str': '216'}, {'cui': 'C0043144', 'cui_str': 'Wheezing'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C4759620', 'cui_str': 'Asthma Predictive Index'}, {'cui': 'C0002191', 'cui_str': 'alpha 1-Antitrypsin'}]","[{'cui': 'C0428734', 'cui_str': 'Flow volume loop'}]","[{'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0231832', 'cui_str': 'Respiratory rate'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0237753', 'cui_str': 'Number'}]",216.0,0.132283,Infants API + were also significantly more related to concave loops (OR = 10.02,"[{'ForeName': 'E', 'Initials': 'E', 'LastName': 'Keklikian', 'Affiliation': 'Paediatric Pulmonology Unit, Paediatric Department, Hospital Quirón Palmaplanas, Palma de Mallorca, Spain. Electronic address: ekekli@gmail.com.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Cornes', 'Affiliation': 'Universidad Favaloro, Buenos Aires, Argentina.'}, {'ForeName': 'C J', 'Initials': 'CJ', 'LastName': 'Cela', 'Affiliation': 'Paediatric Pulmonology Unit, Paediatric Department, Hospital Quirón Palmaplanas, Palma de Mallorca, Spain.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Sanchez Solis', 'Affiliation': ""Paediatric Pulmonology Unit, Virgen de la Arrixaca University Children's Hospital, Murcia, Spain.""}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'García Marcos', 'Affiliation': ""Paediatric Pulmonology Unit, Virgen de la Arrixaca University Children's Hospital, Murcia, Spain.""}, {'ForeName': 'J A', 'Initials': 'JA', 'LastName': 'Castro-Rodriguez', 'Affiliation': 'Paediatric Pulmonology Unit, Division of Pediatrics, Pontificia Universidad Católica de Chile, Santiago, Chile.'}]",Allergologia et immunopathologia,['10.1016/j.aller.2019.12.002'] 210,32040523,The long-term effects of a family based economic empowerment intervention (Suubi+Adherence) on suppression of HIV viral loads among adolescents living with HIV in southern Uganda: Findings from 5-year cluster randomized trial.,"BACKGROUND The rapid scale-up of HIV therapy across Africa has failed to adequately engage adolescents living with HIV (ALWHIV). Retention and viral suppression for this group (ALWHIV) is 50% lower than for adults. Indeed, on the African continent, HIV remains the single leading cause of mortality among adolescents. Strategies tailored to the unqiue developmental and social vulnerabilities of this group are urgently needed to enhance successful treatment. METHODS We carried out a five-year longitudinal cluster randomized trial (ClinicalTrials.gov ID: NCT01790373) with adolescents living with HIV (ALWHIV) ages 10 to 16 years clustered at health care clinics to test the effect of a family economic empowerment (EE) intervention on viral suppression in five districuts in Uganda. In total, 39 accredited health care clinics from study districts with existing procedures tailored to adolescent adherence were eligible to participate in the trial. We used data from 288 youth with detectable HIV viral loads (VL) at baseline (158 -intervention group from 20 clinics, 130 -non-intervention group from 19 clinics). The primary end point was undetectable plasma HIV RNA levels, defined as < 40 copies/ml. We used Kaplan-Meier (KM) analysis and Cox proportional hazard models to estimate intervention effects. FINDINGS The Kaplan-Meier (KM) analysis indicated that an incidence of undetectable VL (0.254) was significantly higher in the intervention condition compared to 0.173 (in non-intervention arm) translated into incidence rate ratio of 1.468 (CI: 1.064-2.038), p = 0.008. Cox regression results showed that along with the family-based EE intervention (adj. HR = 1.446, CI: 1.073-1.949, p = 0.015), higher number of medications per day had significant positive effects on the viral suppression (adj.HR = 1.852, CI: 1.275-2.690, p = 0.001). INTERPRETATION A family economic empowerment intervention improved treatment success for ALWHIV in Uganda. Analyses of cost effectiveness and scalability are needed to advance incorporation of this intervention into routine practice in low and middle-income countries.",2020,"HR = 1.852, CI: 1.275-2.690, p = 0.001). ","['adolescents living with HIV (ALWHIV) ages 10 to 16 years clustered at health care clinics', '288 youth with detectable HIV viral loads (VL) at baseline (158 -intervention group from 20 clinics, 130 -non-intervention group from 19 clinics', 'In total, 39 accredited health care clinics from study districts with existing procedures tailored to adolescent adherence were eligible to participate in the trial', 'adolescents living with HIV in southern Uganda']","['family based economic empowerment intervention (Suubi+Adherence', 'family economic empowerment (EE) intervention']","['Retention and viral suppression', 'viral suppression', 'suppression of HIV viral loads', 'undetectable plasma HIV RNA levels']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C1168369', 'cui_str': 'HIV viral load'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4319552', 'cui_str': '130 (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0041573', 'cui_str': 'Republic of Uganda'}]","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0013557', 'cui_str': 'economics'}, {'cui': 'C0679959', 'cui_str': 'Empowerment'}]","[{'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression (disorder)'}, {'cui': 'C1168369', 'cui_str': 'HIV viral load'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0035668', 'cui_str': 'RNA'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",288.0,0.0770241,"HR = 1.852, CI: 1.275-2.690, p = 0.001). ","[{'ForeName': 'Fred M', 'Initials': 'FM', 'LastName': 'Ssewamala', 'Affiliation': 'Washington University School of Medicine, Washington University in St. Louis, St. Louis, MO, United States of America.'}, {'ForeName': 'Darejan', 'Initials': 'D', 'LastName': 'Dvalishvili', 'Affiliation': 'International Center for Child Health and Development (ICHAD), Brown School, Washington University in St. Louis, St. Louis, MO, United States of America.'}, {'ForeName': 'Claude A', 'Initials': 'CA', 'LastName': 'Mellins', 'Affiliation': 'Department of Psychiatry, New York State Psychiatric Institute, HIV Center for Clinical and Behavioral Studies at Columbia University Medical Center, The City of New York, NY, United States of America.'}, {'ForeName': 'Elvin H', 'Initials': 'EH', 'LastName': 'Geng', 'Affiliation': 'Division of Infectious Diseases, John T. Milliken Department of Internal Medicine, Washington University in St. Louis, St. Louis, MO, United States of America.'}, {'ForeName': 'Fredderick', 'Initials': 'F', 'LastName': 'Makumbi', 'Affiliation': 'School of Public Health, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Torsten B', 'Initials': 'TB', 'LastName': 'Neilands', 'Affiliation': 'Division of Prevention Science, Center for AIDS Prevention Studies (CAPS), Department of Medicine, University of California, San Francisco, San Francisco, CA, United States of America.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'McKay', 'Affiliation': 'International Center for Child Health and Development (ICHAD), Brown School, Washington University in St. Louis, St. Louis, MO, United States of America.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Damulira', 'Affiliation': 'International Center for Child Health and Development (ICHAD), Uganda Office, Masaka, Uganda.'}, {'ForeName': 'Proscovia', 'Initials': 'P', 'LastName': 'Nabunya', 'Affiliation': 'International Center for Child Health and Development (ICHAD), Brown School, Washington University in St. Louis, St. Louis, MO, United States of America.'}, {'ForeName': 'Ozge', 'Initials': 'O', 'LastName': 'Sensoy Bahar', 'Affiliation': 'International Center for Child Health and Development (ICHAD), Brown School, Washington University in St. Louis, St. Louis, MO, United States of America.'}, {'ForeName': 'Gertrude', 'Initials': 'G', 'LastName': 'Nakigozi', 'Affiliation': 'Rakai Health Sciences Program, Kalisizo, Uganda.'}, {'ForeName': 'Godfrey', 'Initials': 'G', 'LastName': 'Kigozi', 'Affiliation': 'Rakai Health Sciences Program, Kalisizo, Uganda.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Byansi', 'Affiliation': 'International Center for Child Health and Development (ICHAD), Brown School, Washington University in St. Louis, St. Louis, MO, United States of America.'}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Mukasa', 'Affiliation': 'International Center for Child Health and Development (ICHAD), Uganda Office, Masaka, Uganda.'}, {'ForeName': 'Flavia', 'Initials': 'F', 'LastName': 'Namuwonge', 'Affiliation': 'International Center for Child Health and Development (ICHAD), Uganda Office, Masaka, Uganda.'}]",PloS one,['10.1371/journal.pone.0228370'] 211,30875097,Effects of Nigella sativa seeds (black cumin) on insulin secretion and lipid profile: A pilot study in healthy volunteers.,"It has been claimed that Nigella sativa seeds (NSS), also known as black cumin, have antidiabetic and lipid-lowering properties. Our pilot study investigated the effects of powdered NSS on insulin secretion and lipid profile in healthy male volunteers. We conducted a double-blind, randomized, placebo-controlled 4-week trial in 30 subjects, receiving NSS powder (1 g/day) or placebo orally (15 subjects/group). Insulin secretion as determined by the hyperglycaemic clamp technique, insulin sensitivity as well as cholesterol and triglycerides serum concentrations, were measured before and after treatment. NSS powder administration was clinically well tolerated. It did not modify fasting glycaemia and insulinaemia, and was ineffective on glucose-induced insulin secretion and insulin sensitivity. No significant changes on serum lipids were observed after treatment in any treatment groups, nor between the two treatment groups. However, in the treated group only, there was a significant correlation between total cholesterol change after treatment and its baseline level (r = -0.71, P = 0.006, n = 13), and between low-density lipoprotein (LDL) cholesterol change after treatment and its baseline level (r = -0.74, P = 0.004, n = 13). No such correlations were found for high-density lipoprotein (HDL) cholesterol, and for triglycerides. These results do not confirm any NSS effect on glucose regulation; however, they suggest that NSS powder may be of interest in lowering lipid concentrations in hyperlipidaemic subjects.",2019,"It did not modify fasting glycaemia and insulinaemia, and was ineffective on glucose-induced insulin secretion and insulin sensitivity.","['30 subjects, receiving NSS powder (1\xa0g/day) or', 'orally (15 subjects/group', 'healthy volunteers', 'healthy male volunteers', 'hyperlipidaemic subjects']","['powdered NSS', 'Nigella sativa seeds (black cumin', 'placebo']","['cholesterol and triglycerides serum concentrations', 'tolerated', 'low-density lipoprotein (LDL) cholesterol change', 'serum lipids', 'fasting glycaemia and insulinaemia', 'glucose-induced insulin secretion and insulin sensitivity', 'Insulin secretion', 'high-density lipoprotein (HDL) cholesterol, and for triglycerides', 'lipid concentrations', 'total cholesterol change', 'insulin secretion and lipid profile']","[{'cui': 'C0032861', 'cui_str': 'Powdered drug preparation'}, {'cui': 'C0439417', 'cui_str': 'g/day'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}]","[{'cui': 'C0032861', 'cui_str': 'Powdered drug preparation'}, {'cui': 'C1140702', 'cui_str': 'Cumin, Black'}, {'cui': 'C0036563', 'cui_str': 'Zygotes, Plant'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C1256369', 'cui_str': 'Insulin Secretion'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0023822', 'cui_str': 'High Density Lipoprotein Cholesterol'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]",30.0,0.105619,"It did not modify fasting glycaemia and insulinaemia, and was ineffective on glucose-induced insulin secretion and insulin sensitivity.","[{'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Pelegrin', 'Affiliation': ""Centre d'Investigation Clinique, CHU de Montpellier, Montpellier, France.""}, {'ForeName': 'Florence', 'Initials': 'F', 'LastName': 'Galtier', 'Affiliation': ""Centre d'Investigation Clinique, CHU de Montpellier, Montpellier, France.""}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Chalançon', 'Affiliation': ""Centre d'Investigation Clinique, CHU de Montpellier, Montpellier, France.""}, {'ForeName': 'Jean-Pierre', 'Initials': 'JP', 'LastName': 'Gagnol', 'Affiliation': ""Centre d'Investigation Clinique, CHU de Montpellier, Montpellier, France.""}, {'ForeName': 'Anne-Marie', 'Initials': 'AM', 'LastName': 'Barbanel', 'Affiliation': 'Pharmacie Saint Eloi, CHU de Montpellier, Montpellier, France.'}, {'ForeName': 'Yves', 'Initials': 'Y', 'LastName': 'Pélissier', 'Affiliation': 'Faculté de Pharmacie, Laboratoire de Pharmacognosie & UMR Qualisud, Université de Montpellier, Montpellier, France.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Larroque', 'Affiliation': 'Faculté de Pharmacie, Laboratoire de Chimie analytique et Bromatologie & UMR Qualisud, Université de Montpellier, Montpellier, France.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Lepape', 'Affiliation': ""Centre d'Investigation Clinique, CHU de Montpellier, Montpellier, France.""}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Faucanié', 'Affiliation': ""Centre d'Investigation Clinique, CHU de Montpellier, Montpellier, France.""}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Gabillaud', 'Affiliation': ""Centre d'Investigation Clinique, CHU de Montpellier, Montpellier, France.""}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Petit', 'Affiliation': ""Centre d'Investigation Clinique, CHU de Montpellier, Montpellier, France.""}, {'ForeName': 'Hugues', 'Initials': 'H', 'LastName': 'Chevassus', 'Affiliation': ""Centre d'Investigation Clinique, CHU de Montpellier, Montpellier, France.""}]",British journal of clinical pharmacology,['10.1111/bcp.13922'] 212,30924163,"Pharmacokinetics, safety and tolerability of the novel β-hCG derived immunomodulatory compound, EA-230.","AIMS EA-230 is a newly developed synthetic linear tetrapeptide (AQGV) derived from the chorionic gonadotropin hormone (β-hCG). We investigated the pharmacokinetics, safety and tolerability of EA-230 in healthy subjects using different administration strategies. METHODS Double-blind, randomized, placebo-controlled, dose-escalating phase I studies in healthy subjects using intravenous administration were conducted. In the single dosage study, 32 subjects were assigned to four single dosage groups (1, 3, 10 or 30 mg/kg). In the multiple dosage study, 24 subjects were assigned to three dosage groups (10, 20 or 30 mg/kg, thrice daily for 3 days). In the continuous dosage study, 24 subjects were assigned to three dosage groups (15, 30, or 90 mg/kg/hour for 2 hours). Pharmacokinetics, safety and tolerability assessments were performed up to 14 days. RESULTS The highest dosage of EA-230 (continuous infusion of 90 mg/kg/hour for 2 hours) showed more than proportional increases in exposure (C max 136%; AUC 0-last 137%), a large volume of distribution (geometric mean and 95% CI: 13 [3-58] L/kg), a high clearance rate (26 [15-43] L/h/kg), and a short half-life (0.35 [0.13-1.0] minutes). EA-230 was well tolerated and no safety concerns were observed. CONCLUSION These dose-escalating phase I studies with different administration strategies reveal a pharmacokinetic profile of EA-230 with a large volume of distribution and a short half-life. Furthermore, EA-230 was well tolerated and no safety issues emerged. These results have enabled further clinical development in a phase IIa trial assessing the pharmacodynamics of this compound during systemic inflammation described elsewhere in this issue.",2019,"EA-230 was well tolerated and no safety concerns were observed. ","['24 subjects', '32 subjects', 'healthy subjects']","['placebo', 'EA-230']","['Pharmacokinetics, safety and tolerability assessments', 'pharmacokinetics, safety and tolerability', 'Pharmacokinetics, safety and tolerability', 'high clearance rate', 'tolerated and no safety concerns']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4079739', 'cui_str': 'EA-230'}]","[{'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}]",32.0,0.0411006,"EA-230 was well tolerated and no safety concerns were observed. ","[{'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'van Groenendael', 'Affiliation': 'Department of Intensive Care Medicine, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Rob', 'Initials': 'R', 'LastName': 'Aarnoutse', 'Affiliation': 'Radboud Institute for Molecular Life Sciences, Radboud Center for Infectious Diseases (RCI), Nijmegen, The Netherlands.'}, {'ForeName': 'Matthijs', 'Initials': 'M', 'LastName': 'Kox', 'Affiliation': 'Department of Intensive Care Medicine, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Lucas', 'Initials': 'L', 'LastName': 'van Eijk', 'Affiliation': 'Department of Intensive Care Medicine, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Pickkers', 'Affiliation': 'Department of Intensive Care Medicine, Radboud University Medical Center, Nijmegen, The Netherlands.'}]",British journal of clinical pharmacology,['10.1111/bcp.13942'] 213,31097609,The Primary-Secondary Care Partnership to Improve Outcomes in Chronic Kidney Disease (PSP-CKD) Study: A Cluster Randomized Trial in Primary Care.,"BACKGROUND Most patients with CKD are managed in the community. Whether nurse-led CKD management programs improve outcomes in patients with CKD in primary care is unclear. METHODS To assess the effect of such a program on the rate of renal function decline in patients with CKD (stages 3-5) in primary care in the United Kingdom, we conducted a cluster randomized trial, the Primary-Secondary Care Partnership to Improve Outcomes in Chronic Kidney Disease study. A software program designed for the study created a data file of patients with CKD in participating practices. In 23 intervention practices (11,651 patients), a CKD nurse practitioner worked with nominated practice leads to interpret the data file and implement guideline-based patient-level CKD management interventions. The 23 control practices (11,706 patients) received a data file but otherwise, continued usual CKD care. The primary outcome was defined at the cluster (practice) level as the change from baseline of the mean eGFR of the patients with CKD at 6-month intervals up to 42 months. Secondary outcomes included numbers of patients coded for CKD, mean BP, numbers of patients achieving National Institute for Health and Care Excellence BP targets for CKD, and proteinuria measurement. RESULTS After 42 months, eGFR did not differ significantly between control and intervention groups. CKD- and proteinuria-related coding improved significantly along with the number of patients achieving BP targets in the intervention group versus usual care. CONCLUSIONS CKD management programs in primary care may not slow progression of CKD, but they may significantly improve processes of care and potentially decrease the cardiovascular disease burden in CKD and related costs.",2019,"CKD- and proteinuria-related coding improved significantly along with the number of patients achieving BP targets in the intervention group versus usual care. ","['patients with CKD (stages 3-5) in primary care in the United Kingdom', 'patients with CKD in participating practices', 'patients with CKD in primary care']","['nurse-led CKD management programs', 'data file but otherwise, continued usual CKD care', 'Primary-Secondary Care Partnership', 'CKD nurse practitioner worked with nominated practice leads to interpret the data file and implement guideline-based patient-level CKD management interventions']","['numbers of patients coded for CKD, mean BP, numbers of patients achieving National Institute for Health and Care Excellence BP targets for CKD, and proteinuria measurement', 'cluster (practice) level as the change from baseline of the mean eGFR', 'CKD- and proteinuria-related coding', 'eGFR', 'Chronic Kidney Disease (PSP-CKD']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3 (qualifier value)'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0041700', 'cui_str': 'United Kingdom'}]","[{'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0242193', 'cui_str': 'Data Files'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C3494402', 'cui_str': 'Secondary Care'}, {'cui': 'C0028657', 'cui_str': 'Nurse practitioner (occupation)'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C1285553', 'cui_str': 'Interprets'}, {'cui': 'C0180853', 'cui_str': 'File, device (physical object)'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C0220845', 'cui_str': 'guidelines'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0009219', 'cui_str': 'Coding'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0033687', 'cui_str': 'Proteinuria'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0025320', 'cui_str': 'Change of Life, Female'}, {'cui': 'C1561643', 'cui_str': 'Chronic Kidney Diseases'}, {'cui': 'C1868193', 'cui_str': 'PSP'}]",,0.0263545,"CKD- and proteinuria-related coding improved significantly along with the number of patients achieving BP targets in the intervention group versus usual care. ","[{'ForeName': 'Rupert W', 'Initials': 'RW', 'LastName': 'Major', 'Affiliation': 'Departments of Health Sciences and.'}, {'ForeName': 'Celia', 'Initials': 'C', 'LastName': 'Brown', 'Affiliation': 'Division of Health Sciences, Warwick Medical School, University of Warwick, Coventry, United Kingdom; and.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Shepherd', 'Affiliation': 'Departments of Health Sciences and.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Rogers', 'Affiliation': 'Departments of Health Sciences and.'}, {'ForeName': 'Warren', 'Initials': 'W', 'LastName': 'Pickering', 'Affiliation': 'Department of Nephrology, Northampton General Hospital, Northampton, Northants, United Kingdom.'}, {'ForeName': 'Graham L', 'Initials': 'GL', 'LastName': 'Warwick', 'Affiliation': 'Department of Nephrology, University Hospitals of Leicester National Health Service Trust, Leicester, United Kingdom.'}, {'ForeName': 'Shaun', 'Initials': 'S', 'LastName': 'Barber', 'Affiliation': 'Leicester Clinical Trials Unit, University of Leicester, Leicester, United Kingdom.'}, {'ForeName': 'Nuzhat B', 'Initials': 'NB', 'LastName': 'Ashra', 'Affiliation': 'Leicester Clinical Trials Unit, University of Leicester, Leicester, United Kingdom.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Morris', 'Affiliation': 'Leicester Clinical Trials Unit, University of Leicester, Leicester, United Kingdom.'}, {'ForeName': 'Nigel J', 'Initials': 'NJ', 'LastName': 'Brunskill', 'Affiliation': 'Department of Nephrology, University Hospitals of Leicester National Health Service Trust, Leicester, United Kingdom; njb18@le.ac.uk.'}]",Journal of the American Society of Nephrology : JASN,['10.1681/ASN.2018101042'] 214,32307515,"A multicentre, pragmatic, cluster randomised, controlled feasibility trial of the POD system of care.","OBJECTIVE to provide a preliminary estimate of the effectiveness of the prevention of delirium (POD) system of care in reducing incident delirium in acute hospital wards and gather data for a future definitive randomised controlled trial. DESIGN cluster randomised and controlled feasibility trial. SETTING sixteen acute care of older people and orthopaedic trauma wards in eight hospitals in England and Wales. PARTICIPANTS patients 65 years and over admitted to participating wards during the trial period. INTERVENTIONS participating wards were randomly assigned to either the POD programme or usual care, determined by existing local policies and practices. The POD programme is a manualised multicomponent delirium prevention intervention that targets 10 risk factors for delirium. The intervention wards underwent a 6-month implementation period before trial recruitment commenced. Main outcome measure incidence of new-onset delirium measured using the Confusion Assessment Method (CAM) measured daily for up to 10 days post consent. RESULTS out of 4449, 3274 patients admitted to the wards were eligible. In total, 714 patients consented (713 registered) to the trial, thirty-three participants (4.6%) withdrew. Adherence to the intervention was classified as at least medium for seven wards. Rates of new-onset delirium were lower than expected and did not differ between groups (24 (7.0%) of participants in the intervention group versus 33 (8.9%) in the control group; odds ratio (95% confidence interval) 0.68 (0.37-1.26); P = 0.2225). CONCLUSIONS based on these findings, a definitive trial is achievable and would need to recruit 5220 patients in 26 two-ward hospital clusters. Trial registration: ISRCTN01187372. Registered 13 March 2014.",2020,"Rates of new-onset delirium were lower than expected and did not differ between groups (24 (7.0%) of participants in the intervention group versus 33 (8.9%) in the control group; odds ratio (95% confidence interval) 0.68 (0.37-1.26); P = 0.2225). ","['sixteen acute care of older people and orthopaedic trauma wards in eight hospitals in England and Wales', 'patients 65\xa0years and over admitted to participating wards during the trial period', '5220 patients in 26 two-ward hospital clusters', 'out of 4449', '714 patients consented (713 registered) to the trial, thirty-three participants (4.6%) withdrew', '3274 patients admitted to the wards were eligible']","['delirium (POD) system of care', 'POD programme or usual care, determined by existing local policies and practices']","['Rates of new-onset delirium', 'incidence of new-onset delirium measured using the Confusion Assessment Method (CAM) measured daily for up to 10\xa0days post consent']","[{'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0419193', 'cui_str': 'Care of aged'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1274117', 'cui_str': 'Trauma & orthopedics'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C0043015', 'cui_str': 'Wales'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0450358', 'cui_str': '33'}, {'cui': 'C4517764', 'cui_str': '4.6'}, {'cui': 'C0424092', 'cui_str': 'Withdrawn'}]","[{'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0242456', 'cui_str': 'Policy'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0009676', 'cui_str': 'Confusional state'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C2711213', 'cui_str': 'Consented'}]",33.0,0.217047,"Rates of new-onset delirium were lower than expected and did not differ between groups (24 (7.0%) of participants in the intervention group versus 33 (8.9%) in the control group; odds ratio (95% confidence interval) 0.68 (0.37-1.26); P = 0.2225). ","[{'ForeName': 'John', 'Initials': 'J', 'LastName': 'Young', 'Affiliation': 'Academic Unit for Ageing and Stroke Research, University of Leeds, Bradford Teaching Hospitals NHS Foundation Trust, Bradford, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Green', 'Affiliation': 'Academic Unit for Ageing and Stroke Research, Bradford Institute for Health Research, Bradford Teaching Hospitals NHS Foundation Trust, Bradford, UK.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Farrin', 'Affiliation': 'Clinical Trials Research Unit, Leeds Institute for Clinical Trials Research, University of Leeds, Leeds, UK.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Collinson', 'Affiliation': 'Clinical Trials Research Unit, Leeds Institute for Clinical Trials Research, University of Leeds, Leeds, UK.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Hartley', 'Affiliation': 'Clinical Trials Research Unit, Leeds Institute for Clinical Trials Research, University of Leeds, Leeds, UK.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Smith', 'Affiliation': 'Academic Unit for Ageing and Stroke Research, Bradford Institute for Health Research, Bradford Teaching Hospitals NHS Foundation Trust, Bradford, UK.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Teale', 'Affiliation': 'Academic Unit for Ageing and Stroke Research, University of Leeds, Bradford Teaching Hospitals NHS Foundation Trust, Bradford, UK.'}, {'ForeName': 'Najma', 'Initials': 'N', 'LastName': 'Siddiqi', 'Affiliation': 'Hull York Medical School, University of York, York, UK.'}, {'ForeName': 'Sharon K', 'Initials': 'SK', 'LastName': 'Inouye', 'Affiliation': 'Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.'}]",Age and ageing,['10.1093/ageing/afaa044'] 215,30652422,Effects of ursodeoxycholic acid on the gut microbiome and colorectal adenoma development.,"It has been previously reported that ursodeoxycholic acid (UDCA), a therapeutic bile acid, reduced risk for advanced colorectal adenoma in men but not women. Interactions between the gut microbiome and fecal bile acid composition as a factor in colorectal cancer neoplasia have been postulated but evidence is limited to small cohorts and animal studies. Using banked stool samples collected as part of a phase III randomized clinical trial of UDCA for the prevention of colorectal adenomatous polyps, we compared change in the microbiome composition after a 3-year intervention in a subset of participants randomized to oral UDCA at 8-10 mg/kg of body weight per day (n = 198) or placebo (n = 203). Study participants randomized to UDCA experienced compositional changes in their microbiome that were statistically more similar to other individuals in the UDCA arm than to those in the placebo arm. This reflected a UDCA-associated shift in microbial community composition (P < 0.001), independent of sex, with no evidence of a UDCA effect on microbial richness (P > 0.05). These UDCA-associated shifts in microbial community distance metrics from baseline to end-of-study were not associated with risk of any or advanced adenoma (all P > 0.05) in men or women. Separate analyses of microbial networks revealed an overrepresentation of Faecalibacterium prausnitzii in the post-UDCA arm and an inverse relationship between F prausnitzii and Ruminococcus gnavus. In men who received UDCA, the overrepresentation of F prausnitzii and underrepresentation of R gnavus were more prominent in those with no adenoma recurrence at follow-up compared to men with recurrence. This relationship was not observed in women. Daily UDCA use modestly influences the relative abundance of microbial species in stool and affects the microbial network composition with suggestive evidence for sex-specific effects of UDCA on stool microbial community composition as a modifier of colorectal adenoma risk.",2019,Separate analyses of microbial networks revealed an overrepresentation of Faecalibacterium prausnitzii in the post-UDCA arm and an inverse relationship between F prausnitzii and Ruminococcus gnavus.,['advanced colorectal adenoma in men but not women'],"['placebo', 'oral UDCA', 'ursodeoxycholic acid (UDCA', 'UDCA', 'ursodeoxycholic acid']","['microbial community distance metrics', 'gut microbiome and colorectal adenoma development', 'microbial richness', 'risk of any or advanced adenoma']","[{'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0555952', 'cui_str': 'Colorectal (qualifier value)'}, {'cui': 'C0001430', 'cui_str': 'Adenoma'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0042105', 'cui_str': 'ursodesoxycholic acid'}]","[{'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C0699680', 'cui_str': 'Metric'}, {'cui': 'C4018878', 'cui_str': 'Gastrointestinal Microbial Community'}, {'cui': 'C0555952', 'cui_str': 'Colorectal (qualifier value)'}, {'cui': 'C0001430', 'cui_str': 'Adenoma'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}]",203.0,0.192193,Separate analyses of microbial networks revealed an overrepresentation of Faecalibacterium prausnitzii in the post-UDCA arm and an inverse relationship between F prausnitzii and Ruminococcus gnavus.,"[{'ForeName': 'Talima', 'Initials': 'T', 'LastName': 'Pearson', 'Affiliation': 'Pathogen and Microbiome Institute, Northern Arizona University, Flagstaff, Arizona.'}, {'ForeName': 'J Gregory', 'Initials': 'JG', 'LastName': 'Caporaso', 'Affiliation': 'Pathogen and Microbiome Institute, Northern Arizona University, Flagstaff, Arizona.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Yellowhair', 'Affiliation': 'University of Arizona Cancer Center, University of Arizona, Tucson, Arizona.'}, {'ForeName': 'Nicholas A', 'Initials': 'NA', 'LastName': 'Bokulich', 'Affiliation': 'Pathogen and Microbiome Institute, Northern Arizona University, Flagstaff, Arizona.'}, {'ForeName': 'Megha', 'Initials': 'M', 'LastName': 'Padi', 'Affiliation': 'Department of Molecular and Cellular Biology, University of Arizona, Tucson, Arizona.'}, {'ForeName': 'Denise J', 'Initials': 'DJ', 'LastName': 'Roe', 'Affiliation': 'University of Arizona Cancer Center, University of Arizona, Tucson, Arizona.'}, {'ForeName': 'Betsy C', 'Initials': 'BC', 'LastName': 'Wertheim', 'Affiliation': 'University of Arizona Cancer Center, University of Arizona, Tucson, Arizona.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Linhart', 'Affiliation': 'Pathogen and Microbiome Institute, Northern Arizona University, Flagstaff, Arizona.'}, {'ForeName': 'Jessica A', 'Initials': 'JA', 'LastName': 'Martinez', 'Affiliation': 'University of Arizona Cancer Center, University of Arizona, Tucson, Arizona.'}, {'ForeName': 'Cherae', 'Initials': 'C', 'LastName': 'Bilagody', 'Affiliation': 'Pathogen and Microbiome Institute, Northern Arizona University, Flagstaff, Arizona.'}, {'ForeName': 'Heidie', 'Initials': 'H', 'LastName': 'Hornstra', 'Affiliation': 'Pathogen and Microbiome Institute, Northern Arizona University, Flagstaff, Arizona.'}, {'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Alberts', 'Affiliation': 'University of Arizona Cancer Center, University of Arizona, Tucson, Arizona.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Lance', 'Affiliation': 'University of Arizona Cancer Center, University of Arizona, Tucson, Arizona.'}, {'ForeName': 'Patricia A', 'Initials': 'PA', 'LastName': 'Thompson', 'Affiliation': 'University of Arizona Cancer Center, University of Arizona, Tucson, Arizona.'}]",Cancer medicine,['10.1002/cam4.1965'] 216,30891820,"Coadministration of the prostaglandin F2α receptor antagonist preterm labour drug candidate OBE022 with magnesium sulfate, atosiban, nifedipine and betamethasone.","AIMS To investigate presence or absence of clinically relevant drug interactions (pharmacokinetic and safety/tolerability) of OBE022 with standard-of-care medicines for preterm labour, enabling coadministration and further clinical development. METHODS Part A: open-label, randomized, 3-period crossover assessing coadministration of single doses of OBE022 (1100 mg) and MgSO 4 . Part B: open-label, single-sequence crossover assessing the interactions following administration of OBE022 (1000 mg/day) at steady state coadministered with single doses of atosiban, nifedipine and betamethasone. Twenty-five healthy nonpregnant women of reproductive age were enrolled (Part A: n = 12; Part B: n = 13). RESULTS OBE022, alone or in combination with standard-of-care medications, was well tolerated. Headache and dizziness were the most frequently reported adverse events; dizziness occurred more often with the nifedipine/OBE022 combination. There were no clinically significant pharmacokinetic interactions when coadministered with MgSO 4 . Co-administration had no notable effect on atosiban exposure. Atosiban reduced exposure to OBE002 (peak concentration [C max ] 22%, area under the concentration-time curve [AUC] 19%). Coadministration with betamethasone slightly increased betamethasone exposure (C max  + 18%, AUC +27%) and OBE002 exposure (C max  + 35%, AUC +15%). These changes were not considered clinically significant. Coadministration with nifedipine slightly increased OBE002 exposure (C max  + 29%, AUC +24%) and markedly increased nifedipine exposure (C max by 2-fold and AUC by 2-fold), which may be clinically significant. CONCLUSIONS The use of OBE022, a PGF2α antagonist prodrug, in combination with standard-of-care medicines may provide new treatment alternatives for preterm labour. All tested combinations were well tolerated. Nifedipine doses could potentially be reduced or staggered when coadministered with OBE022.",2019,"Coadministration with nifedipine slightly increased OBE002 exposure (C max  + 29%, AUC +24%) and markedly increased nifedipine exposure (C max by 2-fold and AUC by 2-fold), which may be clinically significant. ","['Twenty-five healthy nonpregnant women of reproductive age were enrolled ', 'Part A: n\xa0=\xa012']","['betamethasone', 'nifedipine', 'OBE022', 'OBE022 with standard-of-care medicines', 'atosiban, nifedipine and betamethasone', 'magnesium sulfate, atosiban, nifedipine and betamethasone', 'Nifedipine']","['tolerated', 'nifedipine exposure (C max', 'Headache and dizziness', 'adverse events; dizziness', 'OBE002 exposure (C max', 'atosiban exposure', 'betamethasone exposure']","[{'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0005308', 'cui_str': 'Betamethasone'}, {'cui': 'C0028066', 'cui_str': 'Nifedipine'}, {'cui': 'C2936643', 'cui_str': 'Standard of Care'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C0164398', 'cui_str': 'Atosiban'}, {'cui': 'C0024480', 'cui_str': 'Magnesium Sulfate'}]","[{'cui': 'C0028066', 'cui_str': 'Nifedipine'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0164398', 'cui_str': 'Atosiban'}, {'cui': 'C0005308', 'cui_str': 'Betamethasone'}]",,0.0847074,"Coadministration with nifedipine slightly increased OBE002 exposure (C max  + 29%, AUC +24%) and markedly increased nifedipine exposure (C max by 2-fold and AUC by 2-fold), which may be clinically significant. ","[{'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Pohl', 'Affiliation': 'ObsEva SA, 1228, Plan-les-Ouates, Switzerland.'}, {'ForeName': 'Line', 'Initials': 'L', 'LastName': 'Marchand', 'Affiliation': 'ObsEva SA, 1228, Plan-les-Ouates, Switzerland.'}, {'ForeName': 'Jean-Pierre', 'Initials': 'JP', 'LastName': 'Gotteland', 'Affiliation': 'ObsEva SA, 1228, Plan-les-Ouates, Switzerland.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Coates', 'Affiliation': ""Richmond Pharmacology, St. George's University London, UK.""}, {'ForeName': 'Jörg', 'Initials': 'J', 'LastName': 'Täubel', 'Affiliation': ""Richmond Pharmacology, St. George's University London, UK.""}, {'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'Lorch', 'Affiliation': ""Richmond Pharmacology, St. George's University London, UK.""}]",British journal of clinical pharmacology,['10.1111/bcp.13925'] 217,31053766,Androgen decline and survival during docetaxel therapy in metastatic castration resistant prostate cancer (mCRPC).,"BACKGROUND Multiple androgens drive prostate cancer progression and higher pre-treatment levels of androgens, even within the castrate range, have been previously shown to be associated with an improved overall survival (OS) in mCRPC. Docetaxel impairs microtubules, has androgen receptor (AR) inhibitory effects and is used in both the castration resistant and sensitive settings, where androgen dynamics may impact outcome. The present analysis evaluates the association of decline in serum androgen levels (Testosterone (T), Androstenedione (A) and DHEA in docetaxel-treated mCRPC patients with OS. METHODS Data from 1050 men treated on CALGB 90401 with docetaxel, prednisone and either bevacizumab or placebo were evaluated. Eligibility required progressive mCRPC and no prior chemotherapy. Pre-treatment, 6 week and progression serum assays for T, A and DHEA were performed via tandem Liquid Chromatography-Mass Spectrometry (LC-MS/MS). Changes in T, A and DHEA levels from baseline to 6 weeks were calculated as the ratio of 6-week over baseline. The proportional hazards model was used to assess the prognostic significance of changes in T, A, and DHEA from baseline to 6 weeks in predicting OS adjusting for known prognostic factors. RESULTS Median baseline values for T, A, and, DHEA were 1.0, 13.5, and 8.1 ng/dL respectively while 6 week levels were 0.64, 7.0, and 6.8 ng/dL respectively. Median OS for low testosterone decline is 20.9 months vs 26.3 months for high testosterone decline. In multivariable analysis including known prognostic variables, change in testosterone levels was independently associated with greater OS; the hazard ratio for death with each unit increase in the 6-week/baseline ratio is 1.02 (95% CI = 1.01-1.03, p = 0.001). Decline in A and DHEA were not significant predictors of OS. In multivariable analysis change in the serum changes did not predict PFS however the ratio of T at 6-weeks over baseline was prognostic of ≥50% decline in PSA with an odds ratio of 0.93 (95% CI = 0.85-0.98, p-value = 0.039). CONCLUSIONS Declines in testosterone during docetaxel treatment is associated with a longer survival, consistent with a favorable prognostic significance of higher serum androgens in the CRPC.",2020,"In multivariable analysis including known prognostic variables, change in testosterone levels was independently associated with greater OS; the hazard ratio for death with each unit increase in the 6-week/baseline ratio is 1.02 (95% CI = 1.01-1.03, p = 0.001).","['Data from 1050 men treated on CALGB 90401 with', 'metastatic castration resistant prostate cancer (mCRPC']","['Docetaxel', 'Androstenedione (A) and DHEA in docetaxel-treated mCRPC', 'docetaxel therapy', 'docetaxel, prednisone and either bevacizumab or placebo']","['testosterone levels', 'Median OS for low testosterone decline', 'serum androgen levels (Testosterone (T', 'overall survival (OS', 'hazard ratio for death', 'Androgen decline and survival', 'Changes in T, A and DHEA levels']","[{'cui': 'C4517528', 'cui_str': '1050'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C4721208', 'cui_str': 'Metastatic castration-resistant prostate cancer'}]","[{'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0002860', 'cui_str': 'androstanedione'}, {'cui': 'C0011185', 'cui_str': 'prasterone'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0523912', 'cui_str': 'Testosterone measurement (procedure)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1295654', 'cui_str': 'Decreased testosterone level'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0919646', 'cui_str': 'Androgen level'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0002844', 'cui_str': 'Androgenic Compounds'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0011185', 'cui_str': 'prasterone'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",,0.188418,"In multivariable analysis including known prognostic variables, change in testosterone levels was independently associated with greater OS; the hazard ratio for death with each unit increase in the 6-week/baseline ratio is 1.02 (95% CI = 1.01-1.03, p = 0.001).","[{'ForeName': 'Charles J', 'Initials': 'CJ', 'LastName': 'Ryan', 'Affiliation': 'University of Minnesota and Masonic Cancer Center, Minneapolis, MN, USA. ryanc@umn.edu.'}, {'ForeName': 'Sandipan', 'Initials': 'S', 'LastName': 'Dutta', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'William K', 'Initials': 'WK', 'LastName': 'Kelly', 'Affiliation': 'Thomas Jefferson University, Philadelphia, PA, USA.'}, {'ForeName': 'Carly', 'Initials': 'C', 'LastName': 'Russell', 'Affiliation': 'University of California-San Francisco Helen Diller Comprehensive Cancer Center, San Francisco, CA, USA.'}, {'ForeName': 'Eric J', 'Initials': 'EJ', 'LastName': 'Small', 'Affiliation': 'University of California-San Francisco Helen Diller Comprehensive Cancer Center, San Francisco, CA, USA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Morris', 'Affiliation': 'Memorial Sloan Kettering Cancer, New York, NY, USA.'}, {'ForeName': 'Mary-Ellen', 'Initials': 'ME', 'LastName': 'Taplin', 'Affiliation': 'Dana-Farber/Partners Cancer Care, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Halabi', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Prostate cancer and prostatic diseases,['10.1038/s41391-019-0152-3'] 218,30414797,Effect of Intravascular Cooling on Microvascular Obstruction (MVO) in Conscious Patients with ST-Elevation Myocardial Infarction Undergoing Primary PCI: Results from the COOL AMI EU Pilot Study.,"OBJECTIVE COOL AMI EU pilot was a multi-center, randomized controlled trial to assess feasibility and safety of rapid intravascular therapeutic hypothermia (TH) in conscious patients with anterior ST-elevation myocardial infarction (STEMI) undergoing primary PCI (PPCI). We report the effect of hypothermia upon microvascular obstruction (MVO). METHODS Conscious patients with anterior STEMI and symptom duration <6 h were recruited and randomized to PPCI + TH or PPCI alone. TH was induced using the ZOLL® Proteus™ intravascular temperature management system and rapid infusion of 1 L of cold normal saline, with a target temperature of 32 °C. MVO was measured by cardiac magnetic resonance (CMR) at 4 to 6 days post-MI. MVO larger than 3.9% of LV was considered as extensive MVO. RESULTS 50 patients were randomized; mean age was 58 years, and 86% were men. At reperfusion, mean intravascular temperature for the TH group was 33.6 ± 1 °C. The presence of MVO was high and not different in both groups (74% vs. 77%, p = 0.79). The proportion of patients with extensive MVO was 11% in the TH group and 23% in the control group (OR 0.4 95%CI 0.07-2.35, p = 0.30). Patients with extensive MVO showed reduced EF at 4-6 days (34% versus 43%, p = 0.01). The percentage of patients with EF <35% at 30 days was 6% in the TH group versus 24% in the control group (p = 0.19). CONCLUSION In the COOL-AMI Pilot Trial, the presence of MVO in both test groups was high and extensive MVO was related with reduced LVEF. The efficacy of therapeutic hypothermia (TH) in MVO reduction should be tested in a pivotal trial.",2019,"Patients with extensive MVO showed reduced EF at 4-6 days (34% versus 43%, p = 0.01).","['conscious patients with ST-elevation myocardial infarction undergoing primary PCI', 'conscious patients with anterior ST-elevation myocardial infarction (STEMI) undergoing primary PCI (PPCI', 'Conscious patients with anterior STEMI and symptom duration <6\u202fh', '50 patients were randomized; mean age was 58\u202fyears, and 86% were men']","['hypothermia', 'PPCI\u202f+\u202fTH or PPCI alone', 'therapeutic hypothermia (TH', 'intravascular cooling', 'rapid intravascular therapeutic hypothermia (TH']","['mean intravascular temperature', 'cardiac magnetic resonance (CMR', 'presence of MVO', 'reduced EF', 'proportion of patients with extensive MVO', 'MVO', 'microvascular obstruction (MVO']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1536220', 'cui_str': 'ST Elevated Myocardial Infarction'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C0413252', 'cui_str': 'Hypothermia due to exposure'}, {'cui': 'C0020674', 'cui_str': 'Targeted Temperature Management'}, {'cui': 'C0442123', 'cui_str': 'Intravascular (qualifier value)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0442123', 'cui_str': 'Intravascular (qualifier value)'}, {'cui': 'C0039476', 'cui_str': 'Temperature'}, {'cui': 'C0917874', 'cui_str': 'Magnetic Resonance'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205231', 'cui_str': 'Extensive (qualifier value)'}, {'cui': 'C0443258', 'cui_str': 'Microvascular (qualifier value)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}]",50.0,0.113306,"Patients with extensive MVO showed reduced EF at 4-6 days (34% versus 43%, p = 0.01).","[{'ForeName': 'Thomas R', 'Initials': 'TR', 'LastName': 'Keeble', 'Affiliation': 'Department of Cardiology, Essex Cardiothoracic Centre, Basildon & Anglia Ruskin School of Medicine, Chelmsford, UK. Electronic address: Thomas.keeble@btuh.nhs.uk.'}, {'ForeName': 'Grigoris V', 'Initials': 'GV', 'LastName': 'Karamasis', 'Affiliation': 'Department of Cardiology, Essex Cardiothoracic Centre, Basildon & Anglia Ruskin School of Medicine, Chelmsford, UK.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Noc', 'Affiliation': 'University Medical Center Ljubljana, Ljubljana, Slovenia.'}, {'ForeName': 'Beata', 'Initials': 'B', 'LastName': 'Sredniawa', 'Affiliation': 'Department of Cardiology, Silesian Center for Heart Diseases, Medical University of Silesia, SMDZ, Zabrze, Poland.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Aradi', 'Affiliation': 'Heart Center Balatonfüred, Hungary.'}, {'ForeName': 'Aleksandar N', 'Initials': 'AN', 'LastName': 'Neskovic', 'Affiliation': 'Clinical Hospital Center Zemun, Faculty of Medicine, University of Belgrade, Belgrade, Serbia.'}, {'ForeName': 'Håkan', 'Initials': 'H', 'LastName': 'Arheden', 'Affiliation': 'Department of Clinical Physiology, Skane University Hospital, Lund University, Lund, Sweden.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Erlinge', 'Affiliation': 'Department of Cardiology, Skane University Hospital, Lund University, Lund, Sweden.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Holzer', 'Affiliation': 'Department of Emergency Medicine, Medical University of Vienna, Vienna, Austria.'}]",Cardiovascular revascularization medicine : including molecular interventions,['10.1016/j.carrev.2018.09.014'] 219,31221679,Safety of a Restrictive versus Liberal Approach to Red Blood Cell Transfusion on the Outcome of AKI in Patients Undergoing Cardiac Surgery: A Randomized Clinical Trial.,"BACKGROUND Safely reducing red blood cell transfusions can prevent transfusion-related adverse effects, conserve the blood supply, and reduce health care costs. Both anemia and red blood cell transfusion are independently associated with AKI, but observational data are insufficient to determine whether a restrictive approach to transfusion can be used without increasing AKI risk. METHODS In a prespecified kidney substudy of a randomized noninferiority trial, we compared a restrictive threshold for red blood cell transfusion (transfuse if hemoglobin<7.5 g/dl, intraoperatively and postoperatively) with a liberal threshold (transfuse if hemoglobin<9.5 g/dl in the operating room or intensive care unit, or if hemoglobin<8.5 g/dl on the nonintensive care ward). We studied 4531 patients undergoing cardiac surgery with cardiopulmonary bypass who had a moderate-to-high risk of perioperative death. The substudy's primary outcome was AKI, defined as a postoperative increase in serum creatinine of ≥0.3 mg/dl within 48 hours of surgery, or ≥50% within 7 days of surgery. RESULTS Patients in the restrictive-threshold group received significantly fewer transfusions than patients in the liberal-threshold group (1.8 versus 2.9 on average, or 38% fewer transfusions in the restricted-threshold group compared with the liberal-threshold group; P <0.001). AKI occurred in 27.7% of patients in the restrictive-threshold group (624 of 2251) and in 27.9% of patients in the liberal-threshold group (636 of 2280). Similarly, among patients with preoperative CKD, AKI occurred in 33.6% of patients in the restrictive-threshold group (258 of 767) and in 32.5% of patients in the liberal-threshold group (252 of 775). CONCLUSIONS Among patients undergoing cardiac surgery, a restrictive transfusion approach resulted in fewer red blood cell transfusions without increasing the risk of AKI.",2019,AKI occurred in 27.7% of patients in the restrictive-threshold group (624 of 2251) and in 27.9% of patients in the liberal-threshold group (636 of 2280).,"['Patients Undergoing Cardiac Surgery', '4531 patients undergoing cardiac surgery with cardiopulmonary bypass who had a moderate-to-high risk of perioperative death', 'patients undergoing cardiac surgery']","['restrictive threshold for red blood cell transfusion (transfuse if hemoglobin<7.5 g/dl, intraoperatively and postoperatively) with a liberal threshold (transfuse if hemoglobin<9.5 g/dl in the operating room or intensive care unit, or if hemoglobin<8.5 g/dl on the nonintensive care ward', 'Restrictive versus Liberal Approach to Red Blood Cell Transfusion']","['AKI', 'AKI, defined as a postoperative increase in serum creatinine', 'transfusions', 'red blood cell transfusions']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0524727', 'cui_str': 'Surgery, Cardiac'}, {'cui': 'C0007202', 'cui_str': 'Heart-Lung Bypass'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0332167', 'cui_str': 'High risk of (contextual qualifier) (qualifier value)'}, {'cui': 'C1301895', 'cui_str': 'Perioperative death (event)'}]","[{'cui': 'C0449864', 'cui_str': 'Threshold (property) (qualifier value)'}, {'cui': 'C0086252', 'cui_str': 'Red Blood Cell Transfusion'}, {'cui': 'C0439267', 'cui_str': 'g/dL'}, {'cui': 'C0029064', 'cui_str': 'Operating Room'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C1305702', 'cui_str': 'Ward (environment)'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}]","[{'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum (procedure)'}, {'cui': 'C0199960', 'cui_str': 'Transfusion - action (qualifier value)'}, {'cui': 'C0086252', 'cui_str': 'Red Blood Cell Transfusion'}]",4531.0,0.0593935,AKI occurred in 27.7% of patients in the restrictive-threshold group (624 of 2251) and in 27.9% of patients in the liberal-threshold group (636 of 2280).,"[{'ForeName': 'Amit X', 'Initials': 'AX', 'LastName': 'Garg', 'Affiliation': 'Division of Nephrology, Department of Medicine, London Health Sciences Centre and Western University, London, Ontario, Canada; amit.garg@lhsc.on.ca.'}, {'ForeName': 'Neal', 'Initials': 'N', 'LastName': 'Badner', 'Affiliation': 'Department of Anesthesia & Clinical Pharmacology, University of British Columbia, Kelowna, British Columbia, Canada.'}, {'ForeName': 'Sean M', 'Initials': 'SM', 'LastName': 'Bagshaw', 'Affiliation': 'Department of Critical Care Medicine, University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Meaghan S', 'Initials': 'MS', 'LastName': 'Cuerden', 'Affiliation': 'Division of Nephrology, Department of Medicine, London Health Sciences Centre and Western University, London, Ontario, Canada.'}, {'ForeName': 'Dean A', 'Initials': 'DA', 'LastName': 'Fergusson', 'Affiliation': 'Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.'}, {'ForeName': 'Alexander J', 'Initials': 'AJ', 'LastName': 'Gregory', 'Affiliation': 'Department of Anesthesiology, Perioperative and Pain Medicine, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Hall', 'Affiliation': ""Li Ka Shing Knowledge Institute, St. Michael's Hospital, University of Toronto, Toronto, Ontario, Canada.""}, {'ForeName': 'Gregory M T', 'Initials': 'GMT', 'LastName': 'Hare', 'Affiliation': ""Li Ka Shing Knowledge Institute, St. Michael's Hospital, University of Toronto, Toronto, Ontario, Canada.""}, {'ForeName': 'Boris', 'Initials': 'B', 'LastName': 'Khanykin', 'Affiliation': 'Cardiothoracic Anesthesiology Department, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Shay', 'Initials': 'S', 'LastName': 'McGuinness', 'Affiliation': 'Cardiothoracic and Vascular Intensive Care and High Dependency Unit, Auckland City Hospital, Auckland, New Zealand.'}, {'ForeName': 'Chirag R', 'Initials': 'CR', 'LastName': 'Parikh', 'Affiliation': 'Division of Nephrology, Department of Medicine, Johns Hopkins School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Pavel S', 'Initials': 'PS', 'LastName': 'Roshanov', 'Affiliation': 'Population Health Research Institute, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Nadine', 'Initials': 'N', 'LastName': 'Shehata', 'Affiliation': 'Department of Medicine, Mount Sinai Hospital, University of Toronto, Toronto, Ontario, Canada; and.'}, {'ForeName': 'Jessica M', 'Initials': 'JM', 'LastName': 'Sontrop', 'Affiliation': 'Division of Nephrology, Department of Medicine, London Health Sciences Centre and Western University, London, Ontario, Canada.'}, {'ForeName': 'Summer', 'Initials': 'S', 'LastName': 'Syed', 'Affiliation': 'Population Health Research Institute, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'George I', 'Initials': 'GI', 'LastName': 'Tagarakis', 'Affiliation': 'Department of Cardiothoracic Surgery, Aristotle University Hospital of Thessaloniki, Thessaloniki, Greece.'}, {'ForeName': 'Kevin E', 'Initials': 'KE', 'LastName': 'Thorpe', 'Affiliation': ""Li Ka Shing Knowledge Institute, St. Michael's Hospital, University of Toronto, Toronto, Ontario, Canada.""}, {'ForeName': 'Subodh', 'Initials': 'S', 'LastName': 'Verma', 'Affiliation': ""Li Ka Shing Knowledge Institute, St. Michael's Hospital, University of Toronto, Toronto, Ontario, Canada.""}, {'ForeName': 'Ron', 'Initials': 'R', 'LastName': 'Wald', 'Affiliation': ""Li Ka Shing Knowledge Institute, St. Michael's Hospital, University of Toronto, Toronto, Ontario, Canada.""}, {'ForeName': 'Richard P', 'Initials': 'RP', 'LastName': 'Whitlock', 'Affiliation': 'Population Health Research Institute, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'C David', 'Initials': 'CD', 'LastName': 'Mazer', 'Affiliation': ""Li Ka Shing Knowledge Institute, St. Michael's Hospital, University of Toronto, Toronto, Ontario, Canada.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of the American Society of Nephrology : JASN,['10.1681/ASN.2019010004'] 220,31487383,Rituximab is an effective treatment in patients with pemphigus vulgaris and demonstrates a steroid-sparing effect.,"BACKGROUND Corticosteroids (CS) with or without adjuvant immunosuppressant agents are standard treatment for pemphigus vulgaris (PV). The efficacy of adjuvant therapies in minimizing steroid-related adverse events (AEs) is unproven. OBJECTIVES To utilize data collected in a French investigator-initiated, phase III, open-label, randomized controlled trial to demonstrate the efficacy and safety of rituximab and seek approval for its use in PV. METHODS This was an independently conducted post hoc analysis of the moderate-to-severe PV subset enrolled in the Ritux 3 study. Patients were randomized to rituximab plus 0·5 or 1·0 mg kg -1 per day prednisone tapered over 3 or 6 months, or 1·0 or 1·5 mg kg -1 per day prednisone alone tapered over 12 or 18 months, respectively (according to disease severity). The primary end point was complete remission at month 24 without CS (CRoff) for ≥ 2 months, and 24-month efficacy and safety results were also reported. RESULTS At month 24, 34 of 38 patients (90%) on rituximab plus prednisone achieved CRoff ≥ 2 months vs. 10 of 36 patients (28%) on prednisone alone. Median total cumulative prednisone dose was 5800 mg in the rituximab plus prednisone arm vs. 20 520 mg for prednisone alone. Eight of 36 patients (22%) who received prednisone alone withdrew from treatment owing to AEs; one rituximab-plus-prednisone patient withdrew due to pregnancy. Overall, 24 of 36 patients (67%) on prednisone alone experienced a grade 3/4 CS-related AE vs. 13 of 38 patients (34%) on rituximab plus prednisone. CONCLUSIONS In patients with moderate-to-severe PV, rituximab plus short-term prednisone was more effective than prednisone alone. Patients treated with rituximab had less CS exposure and were less likely to experience severe or life-threatening CS-related AEs. What's already known about this topic? Pemphigus vulgaris (PV) is the most common type of pemphigus. Corticosteroids, a standard first-line treatment for PV, have significant side-effects. Although their effects are unproven, adjuvant corticosteroid-sparing agents are routinely used to minimize steroid exposure and corticosteroid-related side-effects. There is evidence that the anti-CD20 antibody rituximab is effective in the treatment of patients with severe recalcitrant pemphigus and in patients with newly diagnosed pemphigus. What does this study add? This study provides a more detailed analysis of patients with PV enrolled in an investigator-initiated trial. Rituximab plus prednisone had a steroid-sparing effect and more patients achieved complete remission off prednisone. Fewer patients experienced grade 3 or grade 4 steroid-related adverse events than those on prednisone alone. This collaboration between academia and industry, utilizing independent post hoc analyses, led to regulatory authority approvals of rituximab in moderate-to-severe PV.",2020,Rituximab-treated patients had less CS exposure and were less likely to experience severe or life-threatening CS-related AEs.,"['moderate to severe PV subset enrolled in the Ritux-3 study (ClinicalTrials', 'pemphigus vulgaris (PV', 'Patients with Pemphigus Vulgaris']","['rituximab plus short-term prednisone', 'rituximab', 'rituximab-plus-prednisone', 'Corticosteroids (CS) with or without adjuvant immunosuppressant agents', 'Rituximab', 'rituximab plus 0.5 or 1.0 mg/kg/day prednisone', 'rituximab plus prednisone', 'prednisone']","['experience severe or life-threatening CS-related AEs', 'complete remission at Month 24 without CS (CRoff']","[{'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0030809', 'cui_str': 'Pemphigus Vulgaris'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}, {'cui': 'C0021081', 'cui_str': 'Immunosuppressants'}, {'cui': 'C0450442', 'cui_str': 'Agent (attribute)'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C3665414', 'cui_str': 'mg/kg/day'}]","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]",,0.042923,Rituximab-treated patients had less CS exposure and were less likely to experience severe or life-threatening CS-related AEs.,"[{'ForeName': 'D M', 'Initials': 'DM', 'LastName': 'Chen', 'Affiliation': 'Genentech, Inc., South San Francisco, CA, U.S.A.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Odueyungbo', 'Affiliation': 'Roche Products Ltd, Mississauga, ON, L5N 5M8, Canada.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Csinady', 'Affiliation': 'F. Hoffmann-La Roche, Basel, Switzerland.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Gearhart', 'Affiliation': 'F. Hoffmann-La Roche, Basel, Switzerland.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Lehane', 'Affiliation': 'Roche Products Ltd, Welwyn Garden City, AL7 1TW, U.K.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Cheu', 'Affiliation': 'Genentech, Inc., South San Francisco, CA, U.S.A.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Maho-Vaillant', 'Affiliation': 'Department of Dermatology, Rouen University Hospital and INSERM U 1234, National Reference Centre on Autoimmune Bullous Disease, Normandy University, 76000, Rouen, France.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Prost-Squarcioni', 'Affiliation': 'Department of Biostatistics, Rouen University Hospital and INSERM U1181, National Reference Centre on Autoimmune Bullous Disease, Normandy University, 76000, Rouen, France.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Hebert', 'Affiliation': 'Department of Dermatology, Rouen University Hospital and INSERM U 1234, National Reference Centre on Autoimmune Bullous Disease, Normandy University, 76000, Rouen, France.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Houivet', 'Affiliation': 'Department of Dermatology, Avicenne Hospital and INSERM UMR1125, Paris 13 University, 93000, Bobigny, France.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Calbo', 'Affiliation': 'Department of Dermatology, Rouen University Hospital and INSERM U 1234, National Reference Centre on Autoimmune Bullous Disease, Normandy University, 76000, Rouen, France.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Caillot', 'Affiliation': 'Department of Dermatology, Rouen University Hospital and INSERM U 1234, National Reference Centre on Autoimmune Bullous Disease, Normandy University, 76000, Rouen, France.'}, {'ForeName': 'M L', 'Initials': 'ML', 'LastName': 'Golinski', 'Affiliation': 'Department of Dermatology, Rouen University Hospital and INSERM U 1234, National Reference Centre on Autoimmune Bullous Disease, Normandy University, 76000, Rouen, France.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Labeille', 'Affiliation': 'Department of Dermatology, University of Saint Etienne, 42023, Saint Etienne, France.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Picard-Dahan', 'Affiliation': 'Department of Dermatology, Bichat - Claude Bernard Hospital, 75018, Paris, France.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Paul', 'Affiliation': 'Department of Dermatology, University of Toulouse, 31013, Toulouse, France.'}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Richard', 'Affiliation': 'Department of Dermatology, Assistance Publique des Hôpitaux de Marseille, Aix Marseille University, UMR 911, INSERM CRO2, 13007, Marseille, France.'}, {'ForeName': 'J D', 'Initials': 'JD', 'LastName': 'Bouaziz', 'Affiliation': 'Department of Dermatology of Saint Louis Hospital, Paris 7 Sorbonne Paris Cité University, 75010, Paris, France.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Duvert-Lehembre', 'Affiliation': 'Department of Dermatology, Rouen University Hospital and INSERM U 1234, National Reference Centre on Autoimmune Bullous Disease, Normandy University, 76000, Rouen, France.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Bernard', 'Affiliation': 'Department of Dermatology, University of Reims, 51100, Reims, France.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Caux', 'Affiliation': 'Department of Biostatistics, Rouen University Hospital and INSERM U1181, National Reference Centre on Autoimmune Bullous Disease, Normandy University, 76000, Rouen, France.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Alexandre', 'Affiliation': 'Department of Biostatistics, Rouen University Hospital and INSERM U1181, National Reference Centre on Autoimmune Bullous Disease, Normandy University, 76000, Rouen, France.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Ingen-Housz-Oro', 'Affiliation': 'Department of Dermatology, APHP, Henri Mondor Hospital, 94010, Créteil, France.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Vabres', 'Affiliation': 'Department of Dermatology, Dijon University Hospital, 21079, Dijon, France.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Delaporte', 'Affiliation': 'Department of Dermatology, University of Lille and Claude-Huriez Hospital, 59037, Lille, France.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Quereux', 'Affiliation': 'Department of Dermatology, University of Nantes, 44035, Nantes, France.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Dupuy', 'Affiliation': 'Department of Dermatology, University of Rennes, 35042, Rennes, France.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Debarbieux', 'Affiliation': 'Department of Dermatology, Centre Hospitalier Lyon Sud, 69310, Pierre Bénite, France.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Avenel-Audran', 'Affiliation': 'Department of Dermatology, University of Angers, 49035, Angers, France.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': ""D'Incan"", 'Affiliation': 'Department of Dermatology, University of Clermont-Ferrand, 63001, Clermont-Ferrand, France.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Bedane', 'Affiliation': 'Department of Dermatology, University of Limoges, 87032, Limoges, France.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Bénéton', 'Affiliation': 'Department of Dermatology, Le Mans General Hospital, 72037, Le Mans, France.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Jullien', 'Affiliation': 'Department of Dermatology, Edouard Herriot Hospital, Lyon Claude Bernard University, 69003, Lyon, France.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Dupin', 'Affiliation': 'Department of Dermatology, Cochin Hospital, University of Paris V, 75006, Paris, France.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Misery', 'Affiliation': 'Department of Dermatology and, Brest University Hospital, 29200, Brest, France.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Machet', 'Affiliation': 'Department of Dermatology, Tours University Hospital, 37044, Tours, France.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Beylot-Barry', 'Affiliation': 'Department of Dermatology, University of Bordeaux, 33076, Bordeaux, France.'}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Dereure', 'Affiliation': 'Department of Dermatology, University of Montpellier, 34090, Montpellier, France.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Sassolas', 'Affiliation': 'Department of Internal Medicine, Brest University Hospital, 29200, Brest, France.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Benichou', 'Affiliation': 'Department of Dermatology, Avicenne Hospital and INSERM UMR1125, Paris 13 University, 93000, Bobigny, France.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Musette', 'Affiliation': 'Department of Dermatology, Rouen University Hospital and INSERM U 1234, National Reference Centre on Autoimmune Bullous Disease, Normandy University, 76000, Rouen, France.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Joly', 'Affiliation': 'Department of Dermatology, Rouen University Hospital and INSERM U 1234, National Reference Centre on Autoimmune Bullous Disease, Normandy University, 76000, Rouen, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The British journal of dermatology,['10.1111/bjd.18482'] 221,31611635,A pilot trial of pembrolizumab plus prostatic cryotherapy for men with newly diagnosed oligometastatic hormone-sensitive prostate cancer.,"BACKGROUND Monotherapy with immune checkpoint inhibitors has generally been unsuccessful in men with advanced prostate cancer. Preclinical data support the notion that cryotherapy may improve immune-mediated and anti-tumor responses. The objective of this study was to assess the safety and feasibility of whole-prostate gland cryotherapy combined with pembrolizumab and androgen deprivation in men with oligometastatic hormone-sensitive prostate cancer. METHODS This single-institution, pilot trial recruited 12 patients with newly diagnosed oligometastatic prostate cancer between 2015 and 2016. Patients underwent whole-prostate cryoablation combined with short-term androgen deprivation (eight months) and pembrolizumab (6 doses). The primary clinical endpoints were the number of patients with a PSA level of <0.6 ng/mL at one year and the frequency of adverse events. Other outcome measures included progression-free survival and systemic therapy-free survival. Exploratory analyses included PD-L1 protein expression. RESULTS Forty two percent (5/12) of patients had a PSAs of <0.6 ng/mL at one year though only 2 of these patients had recovered their testosterone at this time point. Median progression-free survival was 14 months, and median systemic therapy-free survival was 17.5 months. PD-L1 expression was not detectable by IHC in patients with evaluable tissue. All adverse events were grade ≤2, and there were no apparent complications from cryotherapy. CONCLUSIONS Whole-prostate cryoablation combined with short-term androgen deprivation and pembrolizumab treatment was well tolerated and no safety concerns were observed in men with oligometastatic prostate cancer. Though local disease appeared effectively treated in the majority of men, the regimen only infrequency led to sustained disease control following testosterone recovery.",2020,"All adverse events were grade ≤2, and there were no apparent complications from cryotherapy. ","['12 patients with newly diagnosed oligometastatic prostate cancer between 2015 and 2016', 'men with oligometastatic hormone-sensitive prostate cancer', 'patients with evaluable tissue', 'men with newly diagnosed oligometastatic hormone-sensitive prostate cancer', 'men with advanced prostate cancer', 'men with oligometastatic prostate cancer']","['pembrolizumab plus prostatic cryotherapy', 'whole-prostate cryoablation combined with short-term androgen deprivation (eight months) and pembrolizumab', 'whole-prostate gland cryotherapy combined with pembrolizumab and androgen deprivation', 'Whole-prostate cryoablation combined with short-term androgen deprivation and pembrolizumab']","['frequency of adverse events', 'Median progression-free survival', 'tolerated and no safety concerns', 'safety and feasibility', 'progression-free survival and systemic therapy-free survival', 'number of patients with a PSA level', 'median systemic therapy-free survival', 'PD-L1 protein expression', 'PD-L1 expression']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C4302896', 'cui_str': 'Hormone sensitive prostate cancer (disorder)'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}]","[{'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0033572', 'cui_str': 'Prostate'}, {'cui': 'C4551716', 'cui_str': 'Cryotherapy'}, {'cui': 'C0843747', 'cui_str': 'Prostate cryoablation'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0002844', 'cui_str': 'Androgenic Compounds'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0201544', 'cui_str': 'Prostate specific antigen measurement (procedure)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C3854321', 'cui_str': 'Expression'}]",,0.114774,"All adverse events were grade ≤2, and there were no apparent complications from cryotherapy. ","[{'ForeName': 'Ashley E', 'Initials': 'AE', 'LastName': 'Ross', 'Affiliation': 'Department of Urology, The James Buchanan Brady Urological Institute, Johns Hopkins School of Medicine, Baltimore, MD, USA. ashley.ross@usoncology.com.'}, {'ForeName': 'Paula J', 'Initials': 'PJ', 'LastName': 'Hurley', 'Affiliation': 'Department of Urology, The James Buchanan Brady Urological Institute, Johns Hopkins School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Phuoc T', 'Initials': 'PT', 'LastName': 'Tran', 'Affiliation': 'The Sidney Kimmel Cancer Center, Johns Hopkins School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Steven P', 'Initials': 'SP', 'LastName': 'Rowe', 'Affiliation': 'The Russell H. Morgan Department of Radiology and Radiological Sciences, Johns Hopkins School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Benzon', 'Affiliation': 'Department of Urology, The James Buchanan Brady Urological Institute, Johns Hopkins School of Medicine, Baltimore, MD, USA.'}, {'ForeName': ""Tanya O'"", 'Initials': 'TO', 'LastName': 'Neal', 'Affiliation': 'The Department of Oncology, Johns Hopkins School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Chapman', 'Affiliation': 'The Department of Oncology, Johns Hopkins School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Rana', 'Initials': 'R', 'LastName': 'Harb', 'Affiliation': 'The Department of Oncology, Johns Hopkins School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Yelena', 'Initials': 'Y', 'LastName': 'Milman', 'Affiliation': 'The Department of Oncology, Johns Hopkins School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Bruce J', 'Initials': 'BJ', 'LastName': 'Trock', 'Affiliation': 'Department of Urology, The James Buchanan Brady Urological Institute, Johns Hopkins School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Charles G', 'Initials': 'CG', 'LastName': 'Drake', 'Affiliation': 'The Department of Medicine, Columbia University, New York, NY, USA.'}, {'ForeName': 'Emmanuel S', 'Initials': 'ES', 'LastName': 'Antonarakis', 'Affiliation': 'Department of Urology, The James Buchanan Brady Urological Institute, Johns Hopkins School of Medicine, Baltimore, MD, USA.'}]",Prostate cancer and prostatic diseases,['10.1038/s41391-019-0176-8'] 222,31734103,"Safety and efficacy of adjunctive cenobamate (YKP3089) in patients with uncontrolled focal seizures: a multicentre, double-blind, randomised, placebo-controlled, dose-response trial.","BACKGROUND More than a third of patients with epilepsy are treatment resistant, and thus new, more effective therapies to achieve seizure freedom are needed. Cenobamate (YKP3089), an investigational antiepileptic drug, has shown broad-spectrum anticonvulsant activity in preclinical studies and seizure models. We aimed to evaluate the safety, efficacy, and tolerability of adjunctive cenobamate in patients with uncontrolled focal (partial)-onset epilepsy. METHODS We did a multicentre, double-blind, randomised, placebo-controlled, dose-response study at 107 epilepsy and neurology centres in 16 countries. Adult patients (aged 18-70 years) with focal seizures despite treatment with 1-3 antiepileptic drugs were randomly assigned (1:1:1:1) via an interactive web response system, by block sizes of 4 within each country, to adjuvant once daily oral cenobamate at dose groups of 100 mg, 200 mg, or 400 mg, or placebo following an 8-week baseline assessment. Patients, investigators, and study personnel were masked to treatment assignment. The study included a 6-week titration phase and 12-week maintenance phase. The primary efficacy outcomes were percentage change in 28-day focal seizure frequency (focal aware motor, focal impaired awareness, or focal to bilateral tonic-clonic seizures) from baseline analysed in the modified intention-to-treat population (≥1 dose and any post-baseline seizure data) and responder rates (≥50% reduction) analysed in the maintenance phase population (≥1 dose in the maintenance phase and any maintenance phase seizure data). The primary efficacy outcomes were analysed using a hierarchal step-down procedure comparing 200 mg versus placebo, 400 mg versus placebo, then 100 mg versus placebo. Safety and tolerability were compared descriptively across treatment groups for all randomised patients. This study is registered with ClinicalTrials.gov, number NCT01866111. FINDINGS Between July 31, 2013, and June 22, 2015, 437 patients were randomly assigned to either placebo (n=108) or cenobamate 100 mg (n=108), 200 mg (n=110), or 400 mg (n=111). Of these patients, 434 (106 [98%] in placebo group, 108 [100%] in 100 mg group, 109 [99%] in 200 mg group, and 111 [100%] in 400 mg group) were included in the modified intention-to-treat population, and 397 (102 [94%] in placebo group, 102 [94%] in 100 mg group, 98 [89%] in 200 mg group, and 95 [86%] in 400 mg group) were included in the modified intention-to-treat maintenance phase population. Median percentage changes in seizure frequency were -24·0% (IQR -45·0 to -7·0%) for the placebo group compared with -35·5% (-62·5 to -15·0%; p=0·0071) for the 100 mg dose group, -55·0% (-73·0 to -23·0%; p<0·0001) for the 200 mg dose group, and -55·0% (-85·0 to -28·0%; p<0·0001) for the 400 mg dose group. Responder rates during the maintenance phase were 25% (26 of 102 patients) for the placebo group compared with 40% (41 of 102; odds ratio 1·97, 95% CI 1·08-3·56; p=0·0365) for the 100 mg dose group, 56% (55 of 98; 3·74, 2·06-6·80; p<0·0001) for the 200 mg dose group, and 64% (61 of 95; 5·24, 2·84-9·67; p<0·0001) for the 400 mg dose group. Treatment-emergent adverse events occurred in 76 (70%) of 108 patients in the placebo group, 70 (65%) of 108 in the 100 mg group, 84 (76%) of 110 in the 200 mg group, and 100 (90%) of 111 in the 400 mg group. Treatment-emergent adverse events led to discontinuation in five (5%) patients in the placebo group, 11 (10%) in the 100 mg dose group, 15 (14%) in the 200 mg dose group, and 22 (20%) in the 400 mg dose group. One serious case of drug reaction with eosinophilia and systemic symptoms occurred in the 200 mg cenobamate group. No deaths were reported. INTERPRETATION Adjunctive cenobamate reduced focal (partial)-onset seizure frequency, in a dose-related fashion. Treatment-emergent adverse events were most frequent in the highest dose group. Cenobamate appears to be an effective treatment option in patients with uncontrolled focal seizures. FUNDING SK Life Science.",2020,"Responder rates during the maintenance phase were 25% (26 of 102 patients) for the placebo group compared with 40% (41 of 102; odds ratio 1·97, 95% CI 1·08-3·56; p=0·0365) for the 100 mg dose group, 56% (55 of 98; 3·74, 2·06-6·80; p<0·0001) for the 200 mg dose group, and 64% (61 of 95; 5·24, 2·84-9·67; p<0·0001) for the 400 mg dose group.","['107 epilepsy and neurology centres in 16 countries', 'Between July 31, 2013, and June 22, 2015, 437 patients', 'patients with uncontrolled focal (partial)-onset epilepsy', 'Adult patients (aged 18-70 years) with focal seizures despite treatment with 1-3 antiepileptic drugs', 'patients with uncontrolled focal seizures']","['placebo', 'Cenobamate (YKP3089', 'adjunctive cenobamate', 'adjunctive cenobamate (YKP3089', 'cenobamate']","['seizure frequency', 'adverse events', 'safety, efficacy, and tolerability', 'eosinophilia and systemic symptoms', 'Safety and efficacy', 'modified intention-to-treat population (≥1 dose and any post-baseline seizure data) and responder rates', 'percentage change in 28-day focal seizure frequency (focal aware motor, focal impaired awareness, or focal to bilateral tonic-clonic seizures', 'Safety and tolerability', 'Responder rates']","[{'cui': 'C4517529', 'cui_str': 'One hundred and seven'}, {'cui': 'C0014544', 'cui_str': 'Seizure Disorder'}, {'cui': 'C0027855', 'cui_str': 'Neurology'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205234', 'cui_str': 'Focal (qualifier value)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0751495', 'cui_str': 'Seizures, Focal'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0003299', 'cui_str': 'Antiepileptic Agents'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C2240374', 'cui_str': 'Eosinophil count raised (finding)'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0751495', 'cui_str': 'Seizures, Focal'}, {'cui': 'C0205234', 'cui_str': 'Focal (qualifier value)'}, {'cui': 'C0004448', 'cui_str': 'Situational Awareness'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0494475', 'cui_str': 'Generalized Tonic-Clonic Seizures'}]",437.0,0.775707,"Responder rates during the maintenance phase were 25% (26 of 102 patients) for the placebo group compared with 40% (41 of 102; odds ratio 1·97, 95% CI 1·08-3·56; p=0·0365) for the 100 mg dose group, 56% (55 of 98; 3·74, 2·06-6·80; p<0·0001) for the 200 mg dose group, and 64% (61 of 95; 5·24, 2·84-9·67; p<0·0001) for the 400 mg dose group.","[{'ForeName': 'Gregory L', 'Initials': 'GL', 'LastName': 'Krauss', 'Affiliation': 'Department of Neurology, Johns Hopkins University School of Medicine, Baltimore, MD, USA. Electronic address: gkrauss@jhmi.edu.'}, {'ForeName': 'Pavel', 'Initials': 'P', 'LastName': 'Klein', 'Affiliation': 'Mid-Atlantic Epilepsy and Sleep Center, Bethesda, MD, USA.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Brandt', 'Affiliation': 'Department of General Epileptology, Bethel Epilepsy Centre, Mara Hospital, Bielefeld, Germany.'}, {'ForeName': 'Sang Kun', 'Initials': 'SK', 'LastName': 'Lee', 'Affiliation': 'Department of Neurology, Adult Comprehensive Epilepsy Center, Seoul National University Hospital, Seoul, South Korea.'}, {'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Milanov', 'Affiliation': 'Neurology Clinic, Medical University of Sofia, Sofia, Bulgaria.'}, {'ForeName': 'Maja', 'Initials': 'M', 'LastName': 'Milovanovic', 'Affiliation': 'Department for Epilepsies and Clinical Neurophysiology, Institute of Mental Health, Faculty for Special Education and Rehabilitation, University of Belgrade, Belgrade, Serbia.'}, {'ForeName': 'Bernhard J', 'Initials': 'BJ', 'LastName': 'Steinhoff', 'Affiliation': 'Department for Adults, Kork Epilepsy Center, Kehl-Kork, Germany.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Kamin', 'Affiliation': 'Medical Affairs, SK Life Science, Paramus, NJ, USA.'}]",The Lancet. Neurology,['10.1016/S1474-4422(19)30399-0'] 223,32306485,Neural function during emotion processing and modulation associated with treatment response in a randomized clinical trial for posttraumatic stress disorder.,"BACKGROUND Posttraumatic stress disorder (PTSD) has been associated with exaggerated threat processing and deficits in emotion modulation circuitry. It remains unknown how neural circuits are associated with response to evidence-based treatments for PTSD. METHOD We examined associations between PTSD symptoms and indicators of neural response in key emotion processing and modulation regions. Fifty-six military Veterans with PTSD were randomly assigned to one of three evidence-based treatments (prolonged exposure, sertraline, and PE plus sertraline) in a randomized clinical trial (""PROGrESS""; 2018, Contemp Clin Trials, 64, 128-138). Twenty-seven combat-exposed controls (CCs) served as a comparison group at pretreatment. Before and after PTSD treatment, functional magnetic resonance imaging was used to assess brain activation and connectivity during the validated Shifted Attention Emotion Appraisal Task (2003, J Neurosci, 23, 5627-5633; 2013, Biol Psychiatry, 73, 1045-1053). RESULTS Greater activation in emotion processing (anterior insula) and modulation (prefrontal cortex) regions and increased connectivity between attentional control (dorsolateral prefrontal cortex and superior parietal cortex) and emotion processing (amygdala) regions, at pretreatment, were associated with subsequent PTSD symptom improvement. CONCLUSIONS This study is one of the first to examine task-based activation and functional connectivity in a PTSD treatment trial, and provides evidence to suggest that activation in and connectivity between emotion processing and modulation regions are important predictors of treatment response.",2020,"RESULTS Greater activation in emotion processing (anterior insula) and modulation (prefrontal cortex) regions and increased connectivity between attentional control (dorsolateral prefrontal cortex and superior parietal cortex) and emotion processing (amygdala) regions, at pretreatment, were associated with subsequent PTSD symptom improvement. ","['posttraumatic stress disorder', 'Posttraumatic stress disorder (PTSD', 'Fifty-six military Veterans with PTSD']","['evidence-based treatments (prolonged exposure, sertraline, and PE plus sertraline']","['emotion processing (anterior insula) and modulation (prefrontal cortex) regions and increased connectivity between attentional control (dorsolateral prefrontal cortex and superior parietal cortex) and emotion processing (amygdala) regions', 'brain activation and connectivity', 'subsequent PTSD symptom improvement']","[{'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0026126', 'cui_str': 'Military personnel'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}]","[{'cui': 'C1740791', 'cui_str': 'Evidence based treatment'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0074393', 'cui_str': 'Sertraline'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0228259', 'cui_str': 'Anterior insula'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0162783', 'cui_str': 'Prefrontal Cortex'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4019080', 'cui_str': 'Prefrontal Cortex, Dorsolateral'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0030560', 'cui_str': 'Parietal lobe structure'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",56.0,0.0198617,"RESULTS Greater activation in emotion processing (anterior insula) and modulation (prefrontal cortex) regions and increased connectivity between attentional control (dorsolateral prefrontal cortex and superior parietal cortex) and emotion processing (amygdala) regions, at pretreatment, were associated with subsequent PTSD symptom improvement. ","[{'ForeName': 'Elizabeth R', 'Initials': 'ER', 'LastName': 'Duval', 'Affiliation': 'VA Ann Arbor Healthcare System, Ann Arbor, Michigan.'}, {'ForeName': 'Jony', 'Initials': 'J', 'LastName': 'Sheynin', 'Affiliation': 'VA Ann Arbor Healthcare System, Ann Arbor, Michigan.'}, {'ForeName': 'Anthony P', 'Initials': 'AP', 'LastName': 'King', 'Affiliation': 'VA Ann Arbor Healthcare System, Ann Arbor, Michigan.'}, {'ForeName': 'K Luan', 'Initials': 'KL', 'LastName': 'Phan', 'Affiliation': 'Department of Psychiatry and Behavioral Health, The Ohio State University, Columbus, Ohio.'}, {'ForeName': 'Naomi M', 'Initials': 'NM', 'LastName': 'Simon', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, Massachusetts.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Martis', 'Affiliation': 'Department of Psychiatry, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Katherine E', 'Initials': 'KE', 'LastName': 'Porter', 'Affiliation': 'VA Ann Arbor Healthcare System, Ann Arbor, Michigan.'}, {'ForeName': 'Sonya B', 'Initials': 'SB', 'LastName': 'Norman', 'Affiliation': 'Research Service, VA San Diego Healthcare System, San Diego, California.'}, {'ForeName': 'Israel', 'Initials': 'I', 'LastName': 'Liberzon', 'Affiliation': 'VA Ann Arbor Healthcare System, Ann Arbor, Michigan.'}, {'ForeName': 'Sheila A M', 'Initials': 'SAM', 'LastName': 'Rauch', 'Affiliation': 'Mental Health Service Line, VA Atlanta Healthcare System, Decatur, Georgia.'}]",Depression and anxiety,['10.1002/da.23022'] 224,32276003,The beneficial role of FeNO in association with GINA guidelines for titration of inhaled corticosteroids in adult asthma: A randomized study.,"PURPOSE This study aimed to demonstrate the role of fractional concentration of exhaled nitric oxide (FeNO) in association with Global Initiative for Asthma (GINA) guidelines for treatment of adult patients with asthma. METHODS It was a prospective and randomized study. The symptomatic asthmatic patients were randomly divided into two groups: GINA group (followed GINA guidelines; N = 86) or GINA + FeNO group (followed GINA guidelines + FeNO for titration of inhaled corticosteroids - ICS; N = 90). They were followed-up for 9 months. RESULTS In GINA group, 37.2% patients had no treatment and 62.8% patients discontinued treatment vs. 40.0% and 60.0% in GINA + FeNO, respectively. After 3, 6 and 9 months of treatment, the percentage of mild, moderate and severe asthma showed no significant difference between the two groups. At 9th month, Δ moderate asthma (reduction) in GINA + FeNO group was significantly higher than in the GINA group (-22.0% vs. -11.6%; P = 0.018). The improvement of asthma control test (ACT) score was not different between the groups at 9th month (12 ± 6 vs. 10 ± 5; P > 0.05); the level of FeNO reduction in GINA + FeNO group was significantly higher than that in GINA group (-42 ± 11 vs. -35 ± 9; P = 0.022). The daily dose of ICS in GINA + FeNO group was significantly lower than that in GINA group (397 ± 171 vs. 482 ± 240 mcg and 375 ± 203 vs. 424 ± 221 mcg; respectively) at the end of 6 and 9 months. CONCLUSION The use of FeNO in association with GINA guidelines has a beneficial role for accurate daily dose of ICS in adult patients with asthma.",2020,"After 3, 6 and 9 months of treatment, the percentage of mild, moderate and severe asthma showed no significant difference between the two groups.","['symptomatic asthmatic patients', 'adult asthma', 'adult patients with asthma']","['GINA group (followed GINA guidelines; N\xa0=\xa086) or GINA\xa0+\xa0FeNO group (followed GINA guidelines\xa0+\xa0FeNO for titration of inhaled corticosteroids - ICS; N\xa0=\xa090', 'exhaled nitric oxide (FeNO', 'GINA']","['percentage of mild, moderate and severe asthma', 'level of FeNO reduction', 'improvement of asthma control test (ACT) score']","[{'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0424093', 'cui_str': 'Initiative'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0162621', 'cui_str': 'Titration method'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}]","[{'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0581126', 'cui_str': 'Severe asthma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C2733224', 'cui_str': 'Asthma control test score'}]",,0.0308658,"After 3, 6 and 9 months of treatment, the percentage of mild, moderate and severe asthma showed no significant difference between the two groups.","[{'ForeName': 'Tung', 'Initials': 'T', 'LastName': 'Truong-Thanh', 'Affiliation': 'Department of Internal Medicine, Thanh Hoa General Hospital, Thanh Hoa City, Vietnam.'}, {'ForeName': 'Anh', 'Initials': 'A', 'LastName': 'Vo-Thi-Kim', 'Affiliation': 'Department of Public Health, Thang Long University, Hanoi City, Vietnam.'}, {'ForeName': 'Thuc', 'Initials': 'T', 'LastName': 'Vu-Minh', 'Affiliation': 'Department of Airway Diseases, ENT Institute, Hanoi City, Vietnam.'}, {'ForeName': 'Dung', 'Initials': 'D', 'LastName': 'Truong-Viet', 'Affiliation': 'Department of Public Health, Thang Long University, Hanoi City, Vietnam.'}, {'ForeName': 'Huong', 'Initials': 'H', 'LastName': 'Tran-Van', 'Affiliation': 'Department of Public Health, Thang Long University, Hanoi City, Vietnam.'}, {'ForeName': 'Sy', 'Initials': 'S', 'LastName': 'Duong-Quy', 'Affiliation': 'Department of Respiratory Diseases, Lam Dong Medical College, Dalat City, Vietnam; Department of Immuno-Allergology, Penn State Medical College, Hershey, USA. Electronic address: sduongquy.jfvp@gmail.com.'}]",Advances in medical sciences,['10.1016/j.advms.2020.03.001'] 225,32276664,Transfer of motor skill between virtual reality viewed using a head-mounted display and conventional screen environments.,"BACKGROUND Virtual reality viewed using a head-mounted display (HMD-VR) has the potential to be a useful tool for motor learning and rehabilitation. However, when developing tools for these purposes, it is important to design applications that will effectively transfer to the real world. Therefore, it is essential to understand whether motor skills transfer between HMD-VR and conventional screen-based environments and what factors predict transfer. METHODS We randomized 70 healthy participants into two groups. Both groups trained on a well-established measure of motor skill acquisition, the Sequential Visual Isometric Pinch Task (SVIPT), either in HMD-VR or in a conventional environment (i.e., computer screen). We then tested whether the motor skills transferred from HMD-VR to the computer screen, and vice versa. After the completion of the experiment, participants responded to questions relating to their presence in their respective training environment, age, gender, video game use, and previous HMD-VR experience. Using multivariate and univariate linear regression, we then examined whether any personal factors from the questionnaires predicted individual differences in motor skill transfer between environments. RESULTS Our results suggest that motor skill acquisition of this task occurs at the same rate in both HMD-VR and conventional screen environments. However, the motor skills acquired in HMD-VR did not transfer to the screen environment. While this decrease in motor skill performance when moving to the screen environment was not significantly predicted by self-reported factors, there were trends for correlations with presence and previous HMD-VR experience. Conversely, motor skills acquired in a conventional screen environment not only transferred but improved in HMD-VR, and this increase in motor skill performance could be predicted by self-reported factors of presence, gender, age and video game use. CONCLUSIONS These findings suggest that personal factors may predict who is likely to have better transfer of motor skill to and from HMD-VR. Future work should examine whether these and other predictors (i.e., additional personal factors such as immersive tendencies and task-specific factors such as fidelity or feedback) also apply to motor skill transfer from HMD-VR to more dynamic physical environments.",2020,"While this decrease in motor skill performance when moving to the screen environment was not significantly predicted by self-reported factors, there were trends for correlations with presence and previous HMD-VR experience.",['70 healthy participants into two groups'],"['Sequential Visual Isometric Pinch Task (SVIPT), either in HMD-VR or in a conventional environment (i.e., computer screen']","['HMD-VR', 'motor skill performance']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0418416', 'cui_str': 'Pinched'}, {'cui': 'C0030072', 'cui_str': 'Oxymetholone'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}]","[{'cui': 'C0030072', 'cui_str': 'Oxymetholone'}, {'cui': 'C0026612', 'cui_str': 'Motor Skills'}]",70.0,0.0157684,"While this decrease in motor skill performance when moving to the screen environment was not significantly predicted by self-reported factors, there were trends for correlations with presence and previous HMD-VR experience.","[{'ForeName': 'Julia M', 'Initials': 'JM', 'LastName': 'Juliano', 'Affiliation': 'Neural Plasticity and Neurorehabilitation Laboratory, Neuroscience Graduate Program, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Sook-Lei', 'Initials': 'SL', 'LastName': 'Liew', 'Affiliation': 'Neural Plasticity and Neurorehabilitation Laboratory, Division of Occupational Science and Occupational Therapy, University of Southern California, Los Angeles, CA, USA. sliew@usc.edu.'}]",Journal of neuroengineering and rehabilitation,['10.1186/s12984-020-00678-2'] 226,31899491,Effect of Senior Dance (DanSE) on Fall Risk Factors in Older Adults: A Randomized Controlled Trial.,"BACKGROUND Older people's participation in structured exercise programs to improve balance and mobility is low. Senior Dance is an alternative option, as it may provide a safe and fun way of targeting balance. OBJECTIVE The aim was to investigate the effect of Senior Dance on balance, mobility, and cognitive function compared with a control intervention. DESIGN The study was a randomized controlled trial. SETTING/PATIENTS Eighty-two community-dwelling older people aged 60 years or over and cognitively intact were recruited in Brazil. INTERVENTION Participants were randomly allocated to 2 groups: Dance plus education (intervention group) and education alone (control group). The Senior Dance program consisted of 12 weeks of twice-weekly group-based dance classes. Participants in both groups attended a single 1-hour educational session on prevention of falls. MEASUREMENTS The primary outcome was single-leg stance with eyes closed. Secondary outcomes were timed sit-to-stand test, standing balance test, timed 4-m walk, and cognitive function tests, for example, Trail Making Test and Montreal Cognitive Assessment. RESULTS Of the 82 participants randomized, 71 (87%) completed the 12-week follow-up. Single-leg stance with eyes closed (primary outcome) improved in the Senior Dance group (mean difference [MD] = 2.3 seconds, 95% confidence interval [CI] = 1.1 to 3.6) compared with the control group at follow-up. Senior Dance group performed better in the standing balance tests (MD = 3.7 seconds, 95% CI = 0.6 to 6.8) and were faster in the sit-to-stand test (MD = - 3.1 seconds, 95% CI = -4.8 to -1.4) and 4-m walk test (MD = -0.6 seconds, 95% CI = -1.0 to -0.1). There were no significant between-group differences for cognitive function tests. LIMITATIONS Participants and therapists were not blinded. CONCLUSION Senior Dance was effective in improving balance and mobility but not cognitive function in community-dwelling older people.",2020,"Senior Dance group performed better in the standing balance tests (MD = 3.7 seconds, 95% CI: 0.6 to 6.8), were faster in the sit-to-stand test (MD = - 3.1 seconds, 95% CI: -4.8 to -1.4), and 4-meter walk test (MD = ","['Of the 82 participants randomized, 71 (87%) completed the 12-week follow-up', 'Eighty-two community-dwelling older people aged 60\xa0years or over and cognitively intact were recruited in Brazil', 'community-dwelling older people', 'Older Adults']","['Senior Dance (DanSE', 'structured exercise programs', 'Senior Dance plus education (intervention group) and education alone (control group']","['balance, mobility, and cognitive function', 'Fall Risk Factors', 'cognitive function tests', 'single-leg stance with eyes closed', 'balance and mobility', 'timed sit-to-stand test, standing balance test, timed 4-meter walk, and cognitive function tests, eg, Trail Making test and Montreal Cognitive Assessment']","[{'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205266', 'cui_str': 'Intact (qualifier value)'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0010963', 'cui_str': 'Dancing'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}, {'cui': 'C1268740', 'cui_str': 'Fall risk'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0587267', 'cui_str': 'Closed (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C2584297', 'cui_str': 'Seated Position'}, {'cui': 'C3888057', 'cui_str': 'Stand'}, {'cui': 'C0475209', 'cui_str': 'm'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C3496286'}]",82.0,0.111345,"Senior Dance group performed better in the standing balance tests (MD = 3.7 seconds, 95% CI: 0.6 to 6.8), were faster in the sit-to-stand test (MD = - 3.1 seconds, 95% CI: -4.8 to -1.4), and 4-meter walk test (MD = ","[{'ForeName': 'Marcia R', 'Initials': 'MR', 'LastName': 'Franco', 'Affiliation': 'Department of Physical Therapy, Centro Universitário UNA, Minas Gerais, Brazil; Department of Physical Therapy, Faculdade de Ciências e Tecnologia, Universidade Estadual Paulista (UNESP), Presidente Prudente, Sao Paulo, Brazil; Department of Physical Therapy, Regional Public Hospital of Betim, Minas Gerais, Brazil.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Sherrington', 'Affiliation': 'Institute for Musculoskeletal Health, School of Public Health, Faculty of Medicine and Health, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Tiedemann', 'Affiliation': 'Institute for Musculoskeletal Health, School of Public Health, Faculty of Medicine and Health, The University of Sydney.'}, {'ForeName': 'Leani S', 'Initials': 'LS', 'LastName': 'Pereira', 'Affiliation': 'Department of Physical Therapy, Universidade Federal de Minas Gerais (UFMG), Belo Horizonte, Minas Gerais, Brazil.'}, {'ForeName': 'Monica R', 'Initials': 'MR', 'LastName': 'Perracini', 'Affiliation': 'Department of Physical Therapy, Universidade Cidade de São Paulo (UNICID), São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Claudia S G', 'Initials': 'CSG', 'LastName': 'Faria', 'Affiliation': 'Department of Physical Therapy, Faculdade de Ciências e Tecnologia, Universidade Estadual Paulista (UNESP), Presidente Prudente, Sao Paulo, Brazil.'}, {'ForeName': 'Ruben F', 'Initials': 'RF', 'LastName': 'Negrão-Filho', 'Affiliation': 'Department of Physical Therapy, Faculdade de Ciências e Tecnologia, Universidade Estadual Paulista (UNESP), Presidente Prudente, Sao Paulo, Brazil.'}, {'ForeName': 'Rafael Z', 'Initials': 'RZ', 'LastName': 'Pinto', 'Affiliation': 'Department of Physical Therapy, Universidade Federal de Minas Gerais (UFMG), Belo Horizonte, Minas Gerais, Brazil.'}, {'ForeName': 'Carlos M', 'Initials': 'CM', 'LastName': 'Pastre', 'Affiliation': 'Department of Physical Therapy, Faculdade de Ciências e Tecnologia, Universidade Estadual Paulista (UNESP), Presidente Prudente, Sao Paulo, Brazil.'}]",Physical therapy,['10.1093/ptj/pzz187'] 227,31899499,The Effects of Home Exercise in Older Women With Vertebral Fractures: A Pilot Randomized Controlled Trial.,"BACKGROUND Regular exercise is advocated in osteoporosis guidelines to prevent fractures. Few studies have evaluated the effect of exercise on functional performance, posture, and other outcomes that are important to patients after vertebral fractures. OBJECTIVE This pilot study will explore the effect of home exercise versus control on functional performance, posture, and patient-reported outcome measures. DESIGN This study was a parallel 2-arm pilot feasibility trial with 1:1 randomization to exercise or attentional control groups. SETTING This study took place in 5 Canadian and 2 Australian academic or community hospitals/centers. PARTICIPANTS This study included 141 women ≥65 years of age with radiographically confirmed vertebral fractures. INTERVENTION A physical therapist delivered exercise and behavioral counseling in 6 home visits over 8 months and monthly calls. Participants were to exercise ≥3 times weekly. Controls received equal attention. MEASUREMENTS Functional performance, posture, quality of life, pain, and behavior-change outcomes were assessed at baseline and after 6 (questionnaires only) and 12 months. Adherence to exercise was assessed by calendar diary. All t tests examined between-group mean differences (MD) in change from baseline in intention-to-treat and per-protocol analyses. RESULTS There was a small effect of exercise on 5 times sit-to-stand test versus control (MD = -1.58 [95% CI = -3.09 to -0.07], intention-to-treat; MD = -1.49 [95% CI = -3.12 to 0.16], per-protocol). There were no other major or statistically significant MDs for any other measured outcomes after follow-up. Adherence declined over time. LIMITATIONS Treatment effects on variables may have been underestimated due to multiple comparisons and underpowered analyses. CONCLUSIONS Our exploratory estimate of the effect of exercise on functional leg muscle strength was consistent in direction and magnitude with other trials in individuals with vertebral fractures. Declining adherence to home exercise suggests that strategies to enhance long-term adherence might be important in future confirmatory trials.",2020,There was a small effect of exercise on five times sit-to-stand test versus control (MD:,"['patients after vertebral fractures', '141 women ≥65\xa0years with radiographically confirmed vertebral fractures', 'individuals with vertebral fractures', '5 Canadian and 2 Australian academic or community hospitals/centers', 'Older Women With Vertebral Fractures']","['control (MD', 'equal attention', 'home exercise versus control', 'exercise', 'physical therapist delivered exercise and behavioral counseling', 'Home Exercise', 'exercise or attentional control groups']","['Adherence', 'functional leg muscle strength', 'Functional performance, posture, quality of life, pain and behavior-change outcomes']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0080179', 'cui_str': 'Spinal Fractures'}, {'cui': 'C4517572', 'cui_str': 'One hundred and forty-one'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C0020003', 'cui_str': 'Hospitals, Community'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapists'}, {'cui': 'C4546207', 'cui_str': 'Behavioral counseling (procedure)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C3853978'}, {'cui': 'C1262869', 'cui_str': 'Posture'}, {'cui': 'C0034380'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]",141.0,0.179121,There was a small effect of exercise on five times sit-to-stand test versus control (MD:,"[{'ForeName': 'Jenna C', 'Initials': 'JC', 'LastName': 'Gibbs', 'Affiliation': 'Department of Kinesiology and Physical Education, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Caitlin', 'Initials': 'C', 'LastName': 'McArthur', 'Affiliation': 'Department of Medicine, McMaster University, Hamilton, Ontario, Canada; and GERAS Centre for Aging Research, Hamilton Health Sciences, Hamilton, Ontario, Canada.'}, {'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Wark', 'Affiliation': 'Department of Medicine, University of Melbourne, Parkville, Victoria, Australia; and Bone and Mineral Medicine, Royal Melbourne Hospital, Parkville, Victoria, Australia.'}, {'ForeName': 'Lehana', 'Initials': 'L', 'LastName': 'Thabane', 'Affiliation': 'Department of Health Research Methods, Evidence, and Impact, McMaster University.'}, {'ForeName': 'Samuel C', 'Initials': 'SC', 'LastName': 'Scherer', 'Affiliation': 'Department of Medicine, University of Melbourne; Royal Melbourne Hospital; and Broadmeadows Health Services, Northern Health, Melbourne, Australia.'}, {'ForeName': 'Sadhana', 'Initials': 'S', 'LastName': 'Prasad', 'Affiliation': 'Department of Medicine, McMaster University.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Papaioannou', 'Affiliation': 'Department of Medicine, McMaster University; GERAS Centre for Aging Research, Hamilton Health Sciences; and Department of Health Research Methods, Evidence, and Impact, McMaster University.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Mittmann', 'Affiliation': 'Sunnybrook Research Institute, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada.'}, {'ForeName': 'Judi', 'Initials': 'J', 'LastName': 'Laprade', 'Affiliation': 'Department of Surgery, University of Toronto, Toronto, Ontario, Canada; and Ontario Osteoporosis Strategy, Osteoporosis Canada, Toronto, Ontario, Canada.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Kim', 'Affiliation': ""Department of Medicine, University of Toronto; and Centre for Osteoporosis and Bone Health, Women's College Hospital, Toronto, Ontario, Canada.""}, {'ForeName': 'Aliya', 'Initials': 'A', 'LastName': 'Khan', 'Affiliation': 'Department of Medicine, McMaster University.'}, {'ForeName': 'David L', 'Initials': 'DL', 'LastName': 'Kendler', 'Affiliation': 'Department of Medicine, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Keith D', 'Initials': 'KD', 'LastName': 'Hill', 'Affiliation': 'Grad Dip Physio, BAppSc (Physio), School of Primary and Allied Health Care, Peninsula Campus, Monash University, Frankston, Australia.'}, {'ForeName': 'Angela M', 'Initials': 'AM', 'LastName': 'Cheung', 'Affiliation': 'Department of Medicine, University of Toronto; and Osteoporosis Program and Centre of Excellence in Skeletal Health Assessment, University Health Network and Sinai Health System, Toronto, Ontario, Canada.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Bleakney', 'Affiliation': 'Department of Medical Imaging, University of Toronto; and Centre of Excellence in Skeletal Health Assessment, University Health Network and Sinai Health System.'}, {'ForeName': 'Maureen C', 'Initials': 'MC', 'LastName': 'Ashe', 'Affiliation': 'Department of Family Practice, University of British Columbia; and Centre for Hip Health and Mobility, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Jonathan D', 'Initials': 'JD', 'LastName': 'Adachi', 'Affiliation': 'Department of Medicine, McMaster University.'}, {'ForeName': 'Lora M', 'Initials': 'LM', 'LastName': 'Giangregorio', 'Affiliation': 'Department of Kinesiology, University of Waterloo; and Schlegel-University of Waterloo Research Institute for Aging, Waterloo, Ontario, Canada; and KITE, Toronto Rehab-University Health Network, Toronto, Ontario, Canada.'}]",Physical therapy,['10.1093/ptj/pzz188'] 228,32220635,"An Invited Commentary on ""Comparison of the safety and efficacy of single-stage endoscopic retrograde cholangiopancreatography plus laparoscopic cholecystectomy versus two-stage ERCP followed by laparoscopic cholecystectomy six-to-eight weeks later: A randomized controlled trial"" (Int J Surg. 2020;76:37-44).",,2020,,[],['single-stage endoscopic retrograde cholangiopancreatography plus laparoscopic cholecystectomy versus two-stage ERCP'],[],[],"[{'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0008310', 'cui_str': 'ERCP'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0162522', 'cui_str': 'Cholecystectomy, Celioscopic'}]",[],,0.137814,,"[{'ForeName': 'Damiano', 'Initials': 'D', 'LastName': 'Caputo', 'Affiliation': 'Department of Surgery, University Campus Bio-Medico of Rome, Rome, Italy.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Coppola', 'Affiliation': 'Department of Surgery, University Campus Bio-Medico of Rome, Rome, Italy. Electronic address: a.coppola@unicampus.it.'}]","International journal of surgery (London, England)",['10.1016/j.ijsu.2020.03.040'] 229,32012251,"A phase 1, randomized, pharmacokinetic trial of the effect of different meal compositions, whole milk, and alcohol on cannabidiol exposure and safety in healthy subjects.","OBJECTIVE The pharmacokinetics (PK) and safety of single oral 750-mg doses of a plant-derived pharmaceutical formulation of highly purified cannabidiol (CBD; Epidiolex in the USA and Epidyolex in Europe; 100-mg/mL oral solution) were assessed in healthy adults following a high-fat/calorie meal (n = 15), a low-fat/calorie meal (n = 14), whole milk (n = 15), or alcohol (n = 14), relative to the fasted state (n = 29). METHODS Blood samples were collected until 96 hours postdose in each period and evaluated by liquid chromatography and tandem mass spectrometry. PK parameters (maximum observed plasma concentration [C max ], area under the plasma concentration-time curve from time zero to the last observed quantifiable concentration, area under the concentration-time curve from time zero to infinity [AUC 0-∞ ], and time to maximum plasma concentration [t max ]) of CBD and its major metabolites were derived using noncompartmental analysis. RESULTS CBD exposure increased by 3.8-fold for AUC 0-∞ and 5.2-fold for C max when CBD was administered with a high-fat/calorie meal versus fasted. To a lesser extent, a low-fat/calorie meal enhanced CBD exposure versus fasted with a 2.7-fold increase in AUC 0-∞ and a 3.8-fold increase in C max . Similarly, when dosed with whole milk, CBD exposure increased versus fasted by 2.4-fold for AUC 0-∞ and 3.1-fold for C max . Modest elevations in CBD exposure occurred when it was dosed with alcohol: 1.6-fold for AUC 0-∞ and 1.9-fold for C max . No clinically relevant effect of any test condition on CBD t max or t ½ versus the fasted state was apparent. The same trend was seen for the CBD metabolites, except that 7-carboxy-cannabidiol t max was considerably longer when CBD was administered with alcohol (14 vs 4 hours fasted). Inter- and intrasubject variability in PK parameters was moderate to high during the trial. SIGNIFICANCE CBD and metabolite exposures were most affected by a high-fat/calorie meal. CBD exposures also increased with a low-fat/calorie meal, whole milk, or alcohol, but to a lesser extent. CBD was tolerated, and there were no severe or serious adverse events during the trial.",2020,No clinically relevant effect of any test condition on CBD t max or t ½ versus the fasted state was apparent.,"['healthy subjects', 'healthy adults following a high-fat/calorie meal (n\xa0=\xa015), a low-fat/calorie meal (n\xa0=\xa014), whole milk (n\xa0=\xa015), or alcohol (n\xa0=\xa014), relative to the fasted state (n\xa0=\xa029']","['alcohol', 'CBD', 'meal compositions, whole milk, and alcohol']","['severe or serious adverse events', 'CBD exposures', 'CBD exposure', 'PK parameters (maximum observed plasma concentration [C max ], area under the plasma concentration-time curve', 'time to maximum plasma concentration [t max ]) of CBD and its major metabolites', 'CBD metabolites']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C1879985', 'cui_str': 'calorie'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0452717', 'cui_str': 'Whole milk (substance)'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C3875154', 'cui_str': 'Relative to (attribute)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C1301808', 'cui_str': 'State'}]","[{'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0452717', 'cui_str': 'Whole milk (substance)'}]","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C3875135', 'cui_str': 'Observes (attribute)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}]",,0.0351745,No clinically relevant effect of any test condition on CBD t max or t ½ versus the fasted state was apparent.,"[{'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Crockett', 'Affiliation': 'GW Research Ltd, Cambridge, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Critchley', 'Affiliation': 'GW Research Ltd, Cambridge, UK.'}, {'ForeName': 'Bola', 'Initials': 'B', 'LastName': 'Tayo', 'Affiliation': 'GW Research Ltd, Cambridge, UK.'}, {'ForeName': 'Joris', 'Initials': 'J', 'LastName': 'Berwaerts', 'Affiliation': 'GW Research Ltd, Cambridge, UK.'}, {'ForeName': 'Gilmour', 'Initials': 'G', 'LastName': 'Morrison', 'Affiliation': 'GW Research Ltd, Cambridge, UK.'}]",Epilepsia,['10.1111/epi.16419'] 230,31231780,Immunogenicity noninferiority study of 2 doses and 3 doses of an Escherichia coli-produced HPV bivalent vaccine in girls vs. 3 doses in young women.,"A new HPV-16/18 bivalent vaccine expressed by the Escherichia coli has been proven to be efficacious in adult women. A randomized, immunogenicity noninferiority study of this candidate vaccine was conducted in December 2015 in China. Girls aged 9-14 years were randomized to receive 2 doses at months 0 and 6 (n=301) or 3 doses at months 0, 1 and 6 (n=304). Girls aged 15-17 years (n=149) and women aged 18-26 years (n=225) received 3 doses. The objectives included noninferiority analysis of the IgG geometric mean concentration (GMC) ratio (95% CI, lower bound>0.5) to HPV-16 and HPV-18 at month 7 in girls compared with women. In the per-protocol set, the GMC ratio of IgG was noninferior for girls aged 9-17 years receiving 3 doses compared with women (1.76 (95% CI, 1.56, 1.99) for HPV-16 and 1.93 (95% CI, 1.69, 2.21) for HPV-18) and noninferior for girls aged 9-14 years receiving 2 doses compared with women (1.45 (95% CI, 1.25, 1.62) for HPV-16 and 1.17 (95% CI, 1.02, 1.33) for HPV-18). Noninferiority was also demonstrated for neutralizing antibodies. The immunogenicity of the HPV vaccine in girls receiving 3 or 2 doses was noninferior compared with that in young adult women.",2020,The immunogenicity of the HPV vaccine in girls receiving 3 or 2 doses was noninferior compared with that in young adult women.,"['Girls aged 15-17 years (n=149) and women aged 18-26 years (n=225) received 3 doses', 'girls receiving 3 or 2 doses was noninferior compared with that in young adult women', 'girls vs. 3 doses in young women', 'Girls aged 9-14 years', 'December 2015 in China', 'adult women']","['Escherichia coli-produced HPV bivalent vaccine', 'HPV vaccine']","['IgG geometric mean concentration (GMC) ratio', 'GMC ratio of IgG', 'neutralizing antibodies']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0014834', 'cui_str': 'Escherichia coli'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C1512511', 'cui_str': 'HPV Vaccines'}]","[{'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C1142254', 'cui_str': 'Neutralising antibodies'}]",,0.320641,The immunogenicity of the HPV vaccine in girls receiving 3 or 2 doses was noninferior compared with that in young adult women.,"[{'ForeName': 'Yue-Mei', 'Initials': 'YM', 'LastName': 'Hu', 'Affiliation': 'Jiangsu Provincial Center for Disease Control and Prevention, Nanjing, 210009, China.'}, {'ForeName': 'Meng', 'Initials': 'M', 'LastName': 'Guo', 'Affiliation': 'The State Key Laboratory of Molecular Vaccinology and Molecular Diagnostics, National Institute of Diagnostics and Vaccine Development in Infectious Diseases, Collaborative Innovation Center of Biologic Products, School of Public Health, Xiamen University, Xiamen, 361102, China.'}, {'ForeName': 'Chang-Gui', 'Initials': 'CG', 'LastName': 'Li', 'Affiliation': 'National Institute for Food and Drug Control, Beijing, 102629, China.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Chu', 'Affiliation': 'Jiangsu Provincial Center for Disease Control and Prevention, Nanjing, 210009, China.'}, {'ForeName': 'Wen-Gang', 'Initials': 'WG', 'LastName': 'He', 'Affiliation': 'The State Key Laboratory of Molecular Vaccinology and Molecular Diagnostics, National Institute of Diagnostics and Vaccine Development in Infectious Diseases, Collaborative Innovation Center of Biologic Products, School of Public Health, Xiamen University, Xiamen, 361102, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Sheyang Center for Disease Control and Prevention, Sheyang, 244300, China.'}, {'ForeName': 'Jian-Xiang', 'Initials': 'JX', 'LastName': 'Gu', 'Affiliation': 'Sheyang Center for Disease Control and Prevention, Sheyang, 244300, China.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'National Institute for Food and Drug Control, Beijing, 102629, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Zhao', 'Affiliation': 'National Institute for Food and Drug Control, Beijing, 102629, China.'}, {'ForeName': 'Xiang-Hong', 'Initials': 'XH', 'LastName': 'Wu', 'Affiliation': 'Sheyang Center for Disease Control and Prevention, Sheyang, 244300, China.'}, {'ForeName': 'BiZhen', 'Initials': 'B', 'LastName': 'Lin', 'Affiliation': 'Xiamen Innovax Biotech Company, Xiamen, 361022, China.'}, {'ForeName': 'Zhi-Jie', 'Initials': 'ZJ', 'LastName': 'Lin', 'Affiliation': 'Xiamen Innovax Biotech Company, Xiamen, 361022, China.'}, {'ForeName': 'Xing-Mei', 'Initials': 'XM', 'LastName': 'Yao', 'Affiliation': 'The State Key Laboratory of Molecular Vaccinology and Molecular Diagnostics, National Institute of Diagnostics and Vaccine Development in Infectious Diseases, Collaborative Innovation Center of Biologic Products, School of Public Health, Xiamen University, Xiamen, 361102, China.'}, {'ForeName': 'Ya-Fei', 'Initials': 'YF', 'LastName': 'Li', 'Affiliation': 'The State Key Laboratory of Molecular Vaccinology and Molecular Diagnostics, National Institute of Diagnostics and Vaccine Development in Infectious Diseases, Collaborative Innovation Center of Biologic Products, School of Public Health, Xiamen University, Xiamen, 361102, China.'}, {'ForeName': 'FeiXue', 'Initials': 'F', 'LastName': 'Wei', 'Affiliation': 'The State Key Laboratory of Molecular Vaccinology and Molecular Diagnostics, National Institute of Diagnostics and Vaccine Development in Infectious Diseases, Collaborative Innovation Center of Biologic Products, School of Public Health, Xiamen University, Xiamen, 361102, China.'}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': 'The State Key Laboratory of Molecular Vaccinology and Molecular Diagnostics, National Institute of Diagnostics and Vaccine Development in Infectious Diseases, Collaborative Innovation Center of Biologic Products, School of Public Health, Xiamen University, Xiamen, 361102, China.'}, {'ForeName': 'Ying-Ying', 'Initials': 'YY', 'LastName': 'Su', 'Affiliation': 'The State Key Laboratory of Molecular Vaccinology and Molecular Diagnostics, National Institute of Diagnostics and Vaccine Development in Infectious Diseases, Collaborative Innovation Center of Biologic Products, School of Public Health, Xiamen University, Xiamen, 361102, China.'}, {'ForeName': 'Feng-Cai', 'Initials': 'FC', 'LastName': 'Zhu', 'Affiliation': 'Jiangsu Provincial Center for Disease Control and Prevention, Nanjing, 210009, China.'}, {'ForeName': 'Shou-Jie', 'Initials': 'SJ', 'LastName': 'Huang', 'Affiliation': 'The State Key Laboratory of Molecular Vaccinology and Molecular Diagnostics, National Institute of Diagnostics and Vaccine Development in Infectious Diseases, Collaborative Innovation Center of Biologic Products, School of Public Health, Xiamen University, Xiamen, 361102, China.'}, {'ForeName': 'Hui-Rong', 'Initials': 'HR', 'LastName': 'Pan', 'Affiliation': 'Xiamen Innovax Biotech Company, Xiamen, 361022, China.'}, {'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Wu', 'Affiliation': 'The State Key Laboratory of Molecular Vaccinology and Molecular Diagnostics, National Institute of Diagnostics and Vaccine Development in Infectious Diseases, Collaborative Innovation Center of Biologic Products, School of Public Health, Xiamen University, Xiamen, 361102, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'The State Key Laboratory of Molecular Vaccinology and Molecular Diagnostics, National Institute of Diagnostics and Vaccine Development in Infectious Diseases, Collaborative Innovation Center of Biologic Products, School of Public Health, Xiamen University, Xiamen, 361102, China. zhangj@xmu.edu.cn.'}, {'ForeName': 'Ning-Shao', 'Initials': 'NS', 'LastName': 'Xia', 'Affiliation': 'The State Key Laboratory of Molecular Vaccinology and Molecular Diagnostics, National Institute of Diagnostics and Vaccine Development in Infectious Diseases, Collaborative Innovation Center of Biologic Products, School of Public Health, Xiamen University, Xiamen, 361102, China. nsxia@xmu.edu.cn.'}]",Science China. Life sciences,['10.1007/s11427-019-9547-7'] 231,31631570,A new risk score for patients after first recurrence of stage 4 neuroblastoma aged ≥18 months at first diagnosis.,"BACKGROUND The prognosis of patients with recurrences from stage 4 neuroblastoma is not uniformly dismal. The evaluation of new therapies therefore needs to consider the individual risks of the treated patients. This study aims to define clinically useful risk criteria. PATIENTS AND METHODS Inclusion criteria were: first recurrence of neuroblastoma stage 4 aged ≥18 months and enrollment in first line trials between 1997 and 2016. Patients were randomized into a training set (N = 310) and an independent validation set (N = 159). The primary endpoint was secondary event-free survival. The individual treatment elements the patients received during initial and recurrent disease were analyzed as binary and time-dependent variables. A five-step multiple time-dependent Cox regression analysis was performed on the training set to identify prognostic variables adjusted for the individual frontline treatment. The selected variables resulted in a prognostic index (PI) and were used to build a risk score system. The score was validated with the validation set. RESULTS Of the 469 patients, 372 were treated with curative intent and 97 with palliative intent. The PI included the variables number of recurrence organs (hazard ratio [HR] = 2.27), time to recurrence (HR = 2.03), liver metastasis at diagnosis (HR = 1.77), first recurrence at site of the primary tumor (HR = 1.55), and age (HR = 1.29). Three risk groups were built and confirmed in the validation set. The scoring system was likewise useful for the curatively or palliatively treated subgroups. CONCLUSION A new risk score system for patients with first recurrence of stage 4 neuroblastoma aged ≥18 months at diagnosis is proposed.",2019,"The scoring system was likewise useful for the curatively or palliatively treated subgroups. ","['469 patients, 372 were treated with curative intent and 97 with palliative intent', 'patients with first recurrence of stage 4 neuroblastoma aged ≥18\xa0months at diagnosis', 'patients with recurrences from stage 4 neuroblastoma', 'patients after first recurrence of stage 4 neuroblastoma aged ≥18\xa0months at first diagnosis', 'Inclusion criteria were: first recurrence of neuroblastoma stage 4 aged ≥18\xa0months and enrollment in first line trials between 1997 and 2016']",[],"['liver metastasis', 'secondary event-free survival', 'prognostic index (PI', 'time to recurrence']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C1276305', 'cui_str': 'Curative procedure'}, {'cui': 'C1283828', 'cui_str': 'Intentional'}, {'cui': 'C1285530', 'cui_str': 'Palliative'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0441772', 'cui_str': 'Stage level 4 (qualifier value)'}, {'cui': 'C0027819', 'cui_str': 'Neuroblastoma'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0730225', 'cui_str': '1997 (qualifier value)'}]",[],"[{'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}]",372.0,0.0545839,"The scoring system was likewise useful for the curatively or palliatively treated subgroups. ","[{'ForeName': 'Kiana', 'Initials': 'K', 'LastName': 'Kreitz', 'Affiliation': 'Institute of Medical Statistics and Clinical Research, University of Muenster, Muenster, Germany.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Ernst', 'Affiliation': 'Institute of Medical Statistics and Computational Biology, University of Cologne, Cologne, Germany.'}, {'ForeName': 'René', 'Initials': 'R', 'LastName': 'Schmidt', 'Affiliation': 'Institute of Medical Statistics and Clinical Research, University of Muenster, Muenster, Germany.'}, {'ForeName': 'Thorsten', 'Initials': 'T', 'LastName': 'Simon', 'Affiliation': 'Department of Pediatric Oncology and Hematology, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Fischer', 'Affiliation': 'Department of Pediatric Oncology and Hematology, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Volland', 'Affiliation': 'Department of Pediatric Oncology and Hematology, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Hero', 'Affiliation': 'Department of Pediatric Oncology and Hematology, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Berthold', 'Affiliation': 'Department of Pediatric Oncology and Hematology, University of Cologne, Cologne, Germany.'}]",Cancer medicine,['10.1002/cam4.2562'] 232,32310260,"Investigation of ward fidelity to a multicomponent delirium prevention intervention during a multicentre, pragmatic, cluster randomised, controlled feasibility trial.","BACKGROUND delirium is a frequent complication of hospital admission for older people and can be reduced by multicomponent interventions, but implementation and delivery of such interventions is challenging. OBJECTIVE to investigate fidelity to the prevention of delirium system of care within a multicentre, pragmatic, cluster randomised, controlled feasibility trial. SETTING five care of older people and three orthopaedic trauma wards in eight hospitals in England and Wales. DATA COLLECTION research nurse observations of ward practice; case note reviews and examination of documentation. ASSESSMENT 10 health care professionals with experience in older people's care assessed the fidelity to 21 essential implementation components within four domains: intervention installation (five items; maximum score = 5); intervention delivery (12 items; maximum score = 48); intervention coverage (three items; maximum score = 16); and duration of delivery (one item; maximum score = 1). RESULTS the mean score (range) for each domain was: installation 4.5 (3.5-5); delivery 32.6 (range 27.3-38.3); coverage 7.9 (range 4.2-10.1); and duration 0.38 (0-1). Of the 10 delirium risk factors, infection, nutrition, hypoxia and pain were the most and cognitive impairment, sensory impairment and multiple medications the least consistently addressed. Overall fidelity to the intervention was assessed as high (≥80%) in two wards, medium (51-79%) in five wards and low (≤50%) in one ward. CONCLUSION the trial was designed as a pragmatic evaluation, and the findings of medium intervention fidelity are likely to be generalisable to delirium prevention in routine care and provide an important context to interpret the trial outcomes.",2020,"10 health care professionals with experience in older people's care assessed the fidelity to 21 essential implementation components within four domains: intervention installation (five items; maximum score = 5); intervention delivery (12 items; maximum score = 48); intervention coverage (three items; maximum score = 16); and duration of delivery (one item; maximum score = 1). ","[""10 health care professionals with experience in older people's"", 'five care of older people and three orthopaedic trauma wards in eight hospitals in England and Wales']",['multicomponent delirium prevention intervention'],"['Overall fidelity', '10 delirium risk factors, infection, nutrition, hypoxia and pain']","[{'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0419193', 'cui_str': 'Care of aged'}, {'cui': 'C1274117', 'cui_str': 'Trauma & orthopedics'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C0043015', 'cui_str': 'Wales'}]","[{'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",,0.116063,"10 health care professionals with experience in older people's care assessed the fidelity to 21 essential implementation components within four domains: intervention installation (five items; maximum score = 5); intervention delivery (12 items; maximum score = 48); intervention coverage (three items; maximum score = 16); and duration of delivery (one item; maximum score = 1). ","[{'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Smith', 'Affiliation': 'Academic Unit for Ageing and Stroke Research, Bradford Institute for Health Research, Bradford Teaching Hospitals NHS Foundation Trust, Bradford, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Green', 'Affiliation': 'Academic Unit for Ageing and Stroke Research, Bradford Institute for Health Research, Bradford Teaching Hospitals NHS Foundation Trust, Bradford, UK.'}, {'ForeName': 'Najma', 'Initials': 'N', 'LastName': 'Siddiqi', 'Affiliation': 'Hull York Medical School, University of York, York, UK.'}, {'ForeName': 'Sharon K', 'Initials': 'SK', 'LastName': 'Inouye', 'Affiliation': 'Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Collinson', 'Affiliation': 'Clinical Trials Research Unit, Leeds Institute for Clinical Trials Research, University of Leeds, Leeds, UK.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Farrin', 'Affiliation': 'Clinical Trials Research Unit, Leeds Institute for Clinical Trials Research, University of Leeds, Leeds, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Young', 'Affiliation': 'Academic Unit for Ageing and Stroke Research, University of Leeds, Bradford Teaching Hospitals NHS Foundation Trust, Bradford, UK.'}]",Age and ageing,['10.1093/ageing/afaa042'] 233,32305292,Type 2 Diabetes in Older Adults in Long-Term Care Homes: An Educational Intervention to Improve Diabetes Care.,"OBJECTIVES Over 25% of nursing home residents have diabetes. Nurses (registered nurses and registered practical nurses), registered dietitians and personal support workers (PSWs) provide the bulk of diabetes care in long-term care (LTC) homes, but their self-rated diabetes knowledge is poor. In this study, we evaluated the impact of an educational intervention on comfort with, and knowledge of, diabetes management among frontline LTC staff. METHODS We implemented an educational intervention in 2 LTC homes in Ontario that targeted nurses and dietitians, PSWs and physicians. A self-assessment questionnaire and a knowledge test were administered to nurses and dietitians and PSWs before and after the intervention. We also measured pre- and postintervention glycated hemoglobin levels, use of sliding scale insulin and type and dose of diabetes medications prescribed. RESULTS After the intervention, both the nurses and dietitians and PSWs groups demonstrated increased comfort with diabetes management and improved self-appraised knowledge. Among PSWs, knowledge of foot care improved the most, and the nurses and dietitians group had the greatest improvement in knowledge of blood glucose monitoring. In addition, there was reduced use of sliding scale insulin, and in the number of residents requiring renal-based dose reductions of glucose-lowering medications. This intervention was innovative as it targeted different LTC health-care providers; it demonstrated the potential to increase LTC health-care providers' confidence in diabetes management. Future studies could assess the clinical benefits of an educational intervention on rates of hypoglycemia and improving A1C targets. CONCLUSIONS An educational intervention can improve knowledge and comfort of diabetes management of frontline LTC staff.",2020,"Among PSWs, knowledge of foot care improved the most, and the nurses and dietitians group had the greatest improvement in knowledge of blood glucose monitoring.","['Nurses (registered nurses and registered practical nurses), registered dietitians and personal support workers (PSWs', 'Type 2 Diabetes in Older Adults in Long-Term Care Homes', '2 LTC homes in Ontario that targeted nurses and dietitians, PSWs and physicians']",['educational intervention'],"['sliding scale insulin', 'comfort with diabetes management and improved self-appraised knowledge', 'knowledge of blood glucose monitoring', 'rates of hypoglycemia and improving A1C targets', 'pre- and postintervention glycated hemoglobin levels, use of sliding scale insulin and type and dose of diabetes medications prescribed']","[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0687673', 'cui_str': 'Registered nurse'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0334932', 'cui_str': 'Dietitian (general)'}, {'cui': 'C1277251', 'cui_str': 'Has support worker'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C0031831', 'cui_str': 'Physician'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0332246', 'cui_str': 'Sliding'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C4521595', 'cui_str': 'US Military enlisted E3'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0518015', 'cui_str': 'Haemoglobin'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C2239117', 'cui_str': 'Prescription of drug'}]",,0.0202795,"Among PSWs, knowledge of foot care improved the most, and the nurses and dietitians group had the greatest improvement in knowledge of blood glucose monitoring.","[{'ForeName': 'Iliana C', 'Initials': 'IC', 'LastName': 'Lega', 'Affiliation': ""Division of Endocrinology, Women's College Hospital, Toronto, Ontario, Canada; Women's College Research Institute, Women's College Hospital, Toronto, Ontario, Canada; Department of Medicine, University of Toronto, Toronto, Ontario, Canada. Electronic address: iliana.lega@wchospital.ca.""}, {'ForeName': 'Alisha', 'Initials': 'A', 'LastName': 'Kapur', 'Affiliation': ""Women's College Research Institute, Women's College Hospital, Toronto, Ontario, Canada.""}, {'ForeName': 'Freda', 'Initials': 'F', 'LastName': 'Leung', 'Affiliation': 'Scarborough and Rouge Hospital, Toronto, Ontario, Canada.'}, {'ForeName': 'Afshan', 'Initials': 'A', 'LastName': 'Zahedi', 'Affiliation': ""Division of Endocrinology, Women's College Hospital, Toronto, Ontario, Canada; Department of Medicine, University of Toronto, Toronto, Ontario, Canada.""}]",Canadian journal of diabetes,['10.1016/j.jcjd.2020.01.009'] 234,32306296,Safety and Efficacy of Exenatide Once Weekly in Participants with Type 2 Diabetes and Stage 2/3 Chronic Kidney Disease.,"INTRODUCTION The safety and efficacy of exenatide once weekly (EQW) is overall well established. EQW is primarily renally eliminated. In this study, the efficacy and renal and gastrointestinal tolerability of EQW were summarised in participants with type 2 diabetes and chronic kidney disease stage 3 (CKD3; moderate renal impairment; estimated glomerular filtration rate [eGFR] ≥ 30 to < 60 mL/min/1.73 m 2 ) or CKD stage 2 (CKD2; mild renal impairment; eGFR ≥ 60 to < 90 mL/min/1.73 m 2 ). METHODS Data on participants with type 2 diabetes and baseline CKD3 or CKD2 from eight phase 3, double-blind or open-label studies with 26- or 28-week controlled treatment periods were pooled. Participants received EQW or a placebo/non-glucagon-like peptide-1 receptor agonist comparator (sitagliptin, metformin, pioglitazone, dapagliflozin and insulin). RESULTS Participants with baseline CKD3 (N = 182) or CKD2 (N = 772) receiving EQW differed in a number of baseline characteristics, such as age < 65 years, race, mean body mass index and mean type 2 diabetes duration, whereas mean blood pressure and glycated haemoglobin (HbA 1c ) were similar. Mean reductions in HbA 1c , body weight and systolic blood pressure from baseline to week 26/28 in participants receiving EQW were similar between the CKD subgroups. The proportions of participants (CKD3 and CKD2) with any adverse event (AE) were 81% and 72%, respectively, for EQW and 74% and 68%, respectively, for all comparators; those for serious AEs were 2.7% and 3.4%, respectively, for EQW and 6% and 5%, respectively, for all comparators. Gastrointestinal AE rates were higher in the EQW CKD3 subgroup (42.2% of participants) than in the CKD2 (32.8%) subgroup, although rates for nausea and vomiting were similar. There were no dehydration events; one participant in each treatment group had a serious AE of acute kidney injury (EQW with CKD3, n = 1; pioglitazone with CKD2, n = 1). CONCLUSION Exenatide once weekly was well tolerated and demonstrated similar efficacy in participants with type 2 diabetes with mild and moderate renal impairment. TRIAL REGISTRATION ClinicalTrials.gov identifiers: NCT00637273, NCT00676338, NCT02229383, NCT02229396, NCT00641056, NCT01652729, NCT00935532, NCT01003184.",2020,"Gastrointestinal AE rates were higher in the EQW CKD3 subgroup (42.2% of participants) than in the CKD2 (32.8%) subgroup, although rates for nausea and vomiting were similar.","['Participants with baseline', 'participants with type 2 diabetes and chronic kidney disease stage 3 (CKD3; moderate renal impairment; estimated glomerular filtration rate [eGFR]\u2009≥\u200930 to\u2009<\u200960\xa0mL', 'participants with type 2 diabetes and', 'participants with type 2 diabetes with mild and moderate renal impairment', 'Participants with Type 2 Diabetes and Stage 2/3 Chronic Kidney Disease']","['EQW', 'exenatide', 'pioglitazone', 'Exenatide', 'CKD3', 'EQW or a placebo/non-glucagon-like peptide-1 receptor agonist comparator (sitagliptin, metformin, pioglitazone, dapagliflozin and insulin']","['Safety and Efficacy', 'mean blood pressure and glycated haemoglobin (HbA 1c ', 'safety and efficacy', 'nausea and vomiting', 'Gastrointestinal AE rates', 'efficacy and renal and gastrointestinal tolerability', 'adverse event (AE', 'serious AE of acute kidney injury', 'Mean reductions in HbA 1c , body weight and systolic blood pressure']","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C2316787', 'cui_str': 'Chronic kidney disease stage 3'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C1565489', 'cui_str': 'Renal impairment'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}]","[{'cui': 'C0167117', 'cui_str': 'exenatide'}, {'cui': 'C0071097', 'cui_str': 'pioglitazone'}, {'cui': 'C2316787', 'cui_str': 'Chronic kidney disease stage 3'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1562104', 'cui_str': 'Glucagon-like peptide 1 receptor agonist-containing product'}, {'cui': 'C1565750', 'cui_str': 'sitagliptin'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}]",,0.191815,"Gastrointestinal AE rates were higher in the EQW CKD3 subgroup (42.2% of participants) than in the CKD2 (32.8%) subgroup, although rates for nausea and vomiting were similar.","[{'ForeName': 'Cristian', 'Initials': 'C', 'LastName': 'Guja', 'Affiliation': '""Carol Davila"" University of Medicine and Pharmacy, Bucharest, Romania. cristian.guja@b.astral.ro.'}, {'ForeName': 'Juan P', 'Initials': 'JP', 'LastName': 'Frías', 'Affiliation': 'National Research Institute, Los Angeles, CA, USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Suchower', 'Affiliation': 'Kelly Services, Gaithersburg, MD, USA.'}, {'ForeName': 'Elise', 'Initials': 'E', 'LastName': 'Hardy', 'Affiliation': 'AstraZeneca, Gaithersburg, MD, USA.'}, {'ForeName': 'Galina', 'Initials': 'G', 'LastName': 'Marr', 'Affiliation': 'AstraZeneca, Gaithersburg, MD, USA.'}, {'ForeName': 'C David', 'Initials': 'CD', 'LastName': 'Sjöström', 'Affiliation': 'AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Serge A', 'Initials': 'SA', 'LastName': 'Jabbour', 'Affiliation': 'Thomas Jefferson University, Philadelphia, PA, USA.'}]","Diabetes therapy : research, treatment and education of diabetes and related disorders",['10.1007/s13300-020-00815-z'] 235,32306477,The association between anti-insulin aspart antibodies and the pharmacokinetic and pharmacodynamic characteristics of fast-acting insulin aspart in children and adolescents with type 1 diabetes.,"BACKGROUND Fast-acting insulin aspart (faster aspart) is a novel formulation of insulin aspart (IAsp) ensuring ultrafast absorption and effect. AIM To compare the pharmacokinetics between faster aspart and IAsp, based on free or total IAsp measurement, and investigate the association between anti-IAsp antibodies and faster aspart and IAsp pharmacological properties in children and adolescents with type 1 diabetes (T1D). METHODS In a randomized, two-period crossover trial, 12 children, 16 adolescents, and 15 adults (6-11, 12-17, and 18-64 years) received 0.2 U/kg double-blindsingle-dose subcutaneous faster aspart or IAsp followed by a standardized liquid meal test. RESULTS Across age groups, the pharmacokinetic profile was left-shifted including greater early exposure for faster aspart vs IAsp irrespective of free or total IAsp assay. Onset of appearance occurred 2.4 to 5.0 minutes (free) or 1.8 to 3.0 minutes (total) earlier for faster aspart vs IAsp (P < .05). Treatment ratios (faster aspart/IAsp) for 0 to 30 minutes IAsp exposure were 1.60 to 2.11 and 1.62 to 1.96, respectively (children, free: P = .062; otherwise P < .05). The ratio of free/total IAsp for overall exposure (AUC IAsp,0-t ) was negatively associated with anti-IAsp antibody level across age. Pooling with a previous similar trial showed no clear association between anti-IAsp antibodies and meal test 1- or 2-hour postprandial glucose increment independent of age and insulin treatment (R 2 ≤ .070; P ≥ .17). CONCLUSIONS In children and adolescents with T1D, faster aspart provides ultrafast pharmacokinetics irrespective of free or total IAsp assay. Elevated anti-IAsp antibodies are associated with higher total IAsp concentration, but do not impact faster aspart and IAsp glucose-lowering effect.",2020,"The ratio of free/total IAsp for overall exposure (AUC IAsp,0-t ) was negatively associated with anti-IAsp antibody level across age.","['children and adolescents with type 1 diabetes', 'children and adolescents with type 1 diabetes (T1D', '12 children, 16 adolescents and 15 adults (6-11, 12-17 and 18-64 years) received']","['0.2 U/kg double-blind single-dose subcutaneous faster aspart or IAsp followed by a standardized liquid meal test', 'fast-acting insulin aspart', 'Fast-acting insulin aspart (faster aspart']",['Onset of appearance'],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C4517436', 'cui_str': '0.2'}, {'cui': 'C1300561', 'cui_str': 'U/kg'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0123677', 'cui_str': 'Insulin, Aspart, Human'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0301571', 'cui_str': 'Liquid diet'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}]","[{'cui': 'C0332162', 'cui_str': 'Onset of'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}]",12.0,0.0243365,"The ratio of free/total IAsp for overall exposure (AUC IAsp,0-t ) was negatively associated with anti-IAsp antibody level across age.","[{'ForeName': 'Torben', 'Initials': 'T', 'LastName': 'Biester', 'Affiliation': 'Diabetes Centre for Children and Adolescents, Kinder- und Jugendkrankenhaus AUF DER BULT, Hannover, Germany.'}, {'ForeName': 'Thekla', 'Initials': 'T', 'LastName': 'von dem Berge', 'Affiliation': 'Diabetes Centre for Children and Adolescents, Kinder- und Jugendkrankenhaus AUF DER BULT, Hannover, Germany.'}, {'ForeName': 'Line Quist', 'Initials': 'LQ', 'LastName': 'Bendtsen', 'Affiliation': 'Clinical Pharmacology, Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Mette Dahl', 'Initials': 'MD', 'LastName': 'Bendtsen', 'Affiliation': 'Biostatistics, Novo Nordisk A/S, Aalborg Ø, Denmark.'}, {'ForeName': 'Naveen', 'Initials': 'N', 'LastName': 'Rathor', 'Affiliation': 'Global Medical Affairs, Novo Nordisk Service Centre India Private Ltd., Bangalore, India.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Danne', 'Affiliation': 'Diabetes Centre for Children and Adolescents, Kinder- und Jugendkrankenhaus AUF DER BULT, Hannover, Germany.'}, {'ForeName': 'Hanne', 'Initials': 'H', 'LastName': 'Haahr', 'Affiliation': 'Clinical Pharmacology, Novo Nordisk A/S, Søborg, Denmark.'}]",Pediatric diabetes,['10.1111/pedi.13026'] 236,32216784,Correction to: Study protocol for a randomized control trial to investigate the effectiveness of an 8-week mindfulness-integrated cognitive behavior therapy (MiCBT) transdiagnostic group intervention for primary care patients.,After publication of our article [1] the authors have notified us that one of the names has been incorrectly spelled.,2020,After publication of our article [1] the authors have notified us that one of the names has been incorrectly spelled.,['primary care patients'],['8-week mindfulness-integrated cognitive behavior therapy (MiCBT) transdiagnostic group intervention'],[],"[{'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]",[],,0.0161287,After publication of our article [1] the authors have notified us that one of the names has been incorrectly spelled.,"[{'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Francis', 'Affiliation': 'Southern Synergy, Department of Psychiatry, School of Clinical Sciences at Monash Health, Monash University, Clayton, Victoria, 3800, Australia. sefra3@student.monash.edu.'}, {'ForeName': 'Frances', 'Initials': 'F', 'LastName': 'Shawyer', 'Affiliation': 'Southern Synergy, Department of Psychiatry, School of Clinical Sciences at Monash Health, Monash University, Clayton, Victoria, 3800, Australia.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Cayoun', 'Affiliation': 'Mindfulness-integrated Cognitive Behavior Therapy Institute, Hobart, Tasmania, Australia.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Enticott', 'Affiliation': 'Southern Synergy, Department of Psychiatry, School of Clinical Sciences at Monash Health, Monash University, Clayton, Victoria, 3800, Australia.'}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'Meadows', 'Affiliation': 'Southern Synergy, Department of Psychiatry, School of Clinical Sciences at Monash Health, Monash University, Clayton, Victoria, 3800, Australia.'}]",BMC psychiatry,['10.1186/s12888-020-02534-y'] 237,31951263,The Sensor Technology and Rehabilitative Timing (START) Protocol: A Randomized Controlled Trial for the Rehabilitation of Mild Traumatic Brain Injury.,"BACKGROUND Clinical practice for rehabilitation after mild traumatic brain injury (mTBI) is variable, and guidance on when to initiate physical therapy is lacking. Wearable sensor technology may aid clinical assessment, performance monitoring, and exercise adherence, potentially improving rehabilitation outcomes during unsupervised home exercise programs. OBJECTIVE The objectives of this study were to: (1) determine whether initiating rehabilitation earlier than typical will improve outcomes after mTBI, and (2) examine whether using wearable sensors during a home-exercise program will improve outcomes in participants with mTBI. DESIGN This was a randomized controlled trial. SETTING This study will take place within an academic hospital setting at Oregon Health & Science University and Veterans Affairs Portland Health Care System, and in the home environment. PARTICIPANTS This study will include 160 individuals with mTBI. INTERVENTION The early intervention group (n = 80) will receive one-on-one physical therapy 8 times over 6 weeks and complete daily home exercises. The standard care group (n = 80) will complete the same intervention after a 6- to 8-week wait period. One-half of each group will receive wearable sensors for therapist monitoring of patient adherence and quality of movements during their home exercise program. MEASUREMENTS The primary outcome measure will be the Dizziness Handicap Inventory score. Secondary outcome measures will include symptomatology, static and dynamic postural control, central sensorimotor integration posturography, and vestibular-ocular-motor function. LIMITATIONS Potential limitations include variable onset of care, a wide range of ages, possible low adherence and/or withdrawal from the study in the standard of care group, and low Dizziness Handicap Inventory scores effecting ceiling for change after rehabilitation. CONCLUSIONS If initiating rehabilitation earlier improves primary and secondary outcomes post-mTBI, this could help shape current clinical care guidelines for rehabilitation. Additionally, using wearable sensors to monitor performance and adherence may improve home exercise outcomes.",2020,The standard care group (n = 80) will complete the same intervention after a 6 to 8-week wait period.,"['160 individuals with mTBI', 'mild traumatic brain injury (mTBI', 'participants with mTBI', 'Mild Traumatic Brain Injury', 'Academic hospital; Oregon Health & Science University, Portland Veterans Affairs Health Care System, and in the home environment']","['receive one-on-one physical therapy 8 times over 6 weeks and complete daily home-exercises', 'Sensor Technology and Rehabilitative Timing (START', 'Protocol']","['Dizziness Handicap Inventory score', ' symptomatology, static and dynamic postural control, central sensorimotor integration posturography, and vestibular-ocular-motor function']","[{'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C3508472', 'cui_str': 'Mild Traumatic Brain Injury'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0029195', 'cui_str': 'Oregon'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0036397', 'cui_str': 'Science'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0018696', 'cui_str': 'Health Care Systems'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0014406', 'cui_str': 'Environment'}]","[{'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0449243', 'cui_str': 'Timing (attribute)'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}]","[{'cui': 'C4304791', 'cui_str': 'Dizziness Handicap Inventory score'}, {'cui': 'C0441463', 'cui_str': 'Static (qualifier value)'}, {'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C0205278', 'cui_str': 'Postural (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0919611', 'cui_str': 'Posturography'}, {'cui': 'C4521296', 'cui_str': 'Ocular (intended site)'}, {'cui': 'C0234130', 'cui_str': 'Motor function (observable entity)'}]",160.0,0.127954,The standard care group (n = 80) will complete the same intervention after a 6 to 8-week wait period.,"[{'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Parrington', 'Affiliation': 'Department of Neurology, Oregon Health & Science University, Portland, Oregon; and Veterans Affairs Portland Health Care System, Portland, Oregon.'}, {'ForeName': 'Deborah A', 'Initials': 'DA', 'LastName': 'Jehu', 'Affiliation': 'Department of Neurology, Oregon Health & Science University; Djavad Mowafaghian Centre for Brain Health, Centre for Hip Health and Mobility, and Department of Physical Therapy, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Peter C', 'Initials': 'PC', 'LastName': 'Fino', 'Affiliation': 'Department of Neurology, Oregon Health & Science University; Veterans Affairs Portland Health Care System; and Department of Health, Kinesiology, and Recreation, University of Utah, Salt Lake City, Utah.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Stuart', 'Affiliation': 'Department of Neurology, Oregon Health & Science University; and Department of Sport, Exercise and Rehabilitation, Northumbria University, Newcastle upon Tyne, United Kingdom.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Wilhelm', 'Affiliation': 'Department of Neurology, Oregon Health & Science University.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Pettigrew', 'Affiliation': 'Department of Neurology, Oregon Health & Science University.'}, {'ForeName': 'Charles F', 'Initials': 'CF', 'LastName': 'Murchison', 'Affiliation': 'Department of Neurology, Oregon Health & Science University; and Department of Biostatistics at the University of Alabama, Birmingham, Alabama.'}, {'ForeName': 'Mahmoud', 'Initials': 'M', 'LastName': 'El-Gohary', 'Affiliation': 'ADPM Inc, Portland, Oregon.'}, {'ForeName': 'Jess', 'Initials': 'J', 'LastName': 'VanDerwalker', 'Affiliation': 'ADPM Inc.'}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'Pearson', 'Affiliation': 'ADPM Inc.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Hullar', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Oregon Health & Science University.'}, {'ForeName': 'James C', 'Initials': 'JC', 'LastName': 'Chesnutt', 'Affiliation': 'Departments of Family Medicine, Neurology, and Orthopedics & Rehabilitation, Oregon Health & Science University.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Peterka', 'Affiliation': 'National Center for Rehabilitative Auditory Research, Veterans Affairs Portland Health Care System.'}, {'ForeName': 'Fay B', 'Initials': 'FB', 'LastName': 'Horak', 'Affiliation': 'Department of Neurology, Oregon Health & Science University; Veterans Affairs Portland Health Care System; and APDM Inc.'}, {'ForeName': 'Laurie A', 'Initials': 'LA', 'LastName': 'King', 'Affiliation': 'Department of Neurology, Oregon Health & Science University, 3181 SW Sam Jackson Park Rd, Portland, OR 97239 (USA); Veterans Affairs Portland Health Care System; and National Center for Rehabilitative Auditory Research, Veterans Affairs Portland Health Care System.'}]",Physical therapy,['10.1093/ptj/pzaa007'] 238,32042108,Interplay of chronotype and school timing predicts school performance.,"Most adolescents exhibit very late chronotypes and attend school early in the morning, a misalignment that can affect their health and psychological well-being. Here we examine how the interaction between the chronotype and school timing of an individual influences academic performance, studying a unique sample of 753 Argentinian students who were randomly assigned to start school in the morning (07:45), afternoon (12:40) or evening (17:20). Although chronotypes tend to align partially with class time, this effect is insufficient to fully account for the differences with school start time. We show that (1) for morning-attending students, early chronotypes perform better than late chronotypes in all school subjects, an effect that is largest for maths; (2) this effect vanishes for students who attend school in the afternoon; and (3) late chronotypes benefit from evening classes. Together, these results demonstrate that academic performance is improved when school times are better aligned with the biological rhythms of adolescents.",2020,"We show that (1) for morning-attending students, early chronotypes perform better than late chronotypes in all school subjects, an effect that is largest for maths; (2) this effect vanishes for students who attend school in the afternoon; and (3) late chronotypes benefit from evening classes.","['753 Argentinian students who were randomly assigned to start school in the morning (07:45), afternoon (12:40) or evening (17:20']",[],[],"[{'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0332170', 'cui_str': 'Morning (qualifier value)'}, {'cui': 'C0439550', 'cui_str': 'Afternoon (qualifier value)'}, {'cui': 'C0587117', 'cui_str': 'Evening (qualifier value)'}]",[],[],753.0,0.0255991,"We show that (1) for morning-attending students, early chronotypes perform better than late chronotypes in all school subjects, an effect that is largest for maths; (2) this effect vanishes for students who attend school in the afternoon; and (3) late chronotypes benefit from evening classes.","[{'ForeName': 'Andrea P', 'Initials': 'AP', 'LastName': 'Goldin', 'Affiliation': 'Universidad Torcuato Di Tella, CONICET, Laboratorio de Neurociencia, Buenos Aires, Argentina.'}, {'ForeName': 'Mariano', 'Initials': 'M', 'LastName': 'Sigman', 'Affiliation': 'Universidad Torcuato Di Tella, CONICET, Laboratorio de Neurociencia, Buenos Aires, Argentina.'}, {'ForeName': 'Gisela', 'Initials': 'G', 'LastName': 'Braier', 'Affiliation': 'Universidad Torcuato Di Tella, CONICET, Laboratorio de Neurociencia, Buenos Aires, Argentina.'}, {'ForeName': 'Diego A', 'Initials': 'DA', 'LastName': 'Golombek', 'Affiliation': 'Universidad Nacional de Quilmes, CONICET, Laboratorio de Cronobiología, Departamento de Ciencia y Tecnología, Buenos Aires, Argentina.'}, {'ForeName': 'María J', 'Initials': 'MJ', 'LastName': 'Leone', 'Affiliation': 'Universidad Torcuato Di Tella, CONICET, Laboratorio de Neurociencia, Buenos Aires, Argentina. mleone@utdt.edu.'}]",Nature human behaviour,['10.1038/s41562-020-0820-2'] 239,31385428,Chronic obstructive pulmonary disease exacerbation episodes derived from electronic health record data validated using clinical trial data.,"PURPOSE To validate an algorithm for acute exacerbations of chronic obstructive pulmonary disease (AECOPD) episodes derived in an electronic health record (EHR) database, against AECOPD episodes collected in a randomized clinical trial using an electronic case report form (eCRF). METHODS We analyzed two data sources from the Salford Lung Study in COPD: trial eCRF and the Salford Integrated Record, a linked primary-secondary routine care EHR database of all patients in Salford. For trial participants, AECOPD episodes reported in eCRF were compared with algorithmically derived moderate/severe AECOPD episodes identified in EHR. Episode characteristics (frequency, duration), sensitivity, and positive predictive value (PPV) were calculated. A match between eCRF and EHR episodes was defined as at least 1-day overlap. RESULTS In the primary effectiveness analysis population (n = 2269), 3791 EHR episodes (mean [SD] length: 15.1 [3.59] days; range: 14-54) and 4403 moderate/severe AECOPD eCRF episodes (mean length: 13.8 [16.20] days; range: 1-372) were identified. eCRF episodes exceeding 28 days were usually broken up into shorter episodes in the EHR. Sensitivity was 63.6% and PPV 71.1%, where concordance was defined as at least 1-day overlap. CONCLUSIONS The EHR algorithm performance was acceptable, indicating that EHR-derived AECOPD episodes may provide an efficient, valid method of data collection. Comparing EHR-derived AECOPD episodes with those collected by eCRF resulted in slightly fewer episodes, and eCRF episodes of extreme lengths were poorly captured in EHR. Analysis of routinely collected EHR data may be reasonable when relative, rather than absolute, rates of AECOPD are relevant for stakeholders' decision making.",2019,"Sensitivity was 63.6% and PPV 71.1%, where concordance was defined as at least 1-day overlap. ","['Chronic obstructive pulmonary disease exacerbation episodes', 'population (n = 2269), 3791 EHR episodes (mean [SD] length: 15.1 [3.59] days; range: 14-54) and 4403 moderate/severe AECOPD eCRF episodes (mean length: 13.8 [16.20] days; range: 1-372) were identified']",[],"['eCRF episodes', 'Sensitivity', 'Episode characteristics (frequency, duration), sensitivity, and positive predictive value (PPV']","[{'cui': 'C3508933', 'cui_str': 'Chronic obstructive pulmonary disease exacerbation'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C4517561', 'cui_str': '13.8 (qualifier value)'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}]",[],"[{'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",,0.351937,"Sensitivity was 63.6% and PPV 71.1%, where concordance was defined as at least 1-day overlap. ","[{'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Sperrin', 'Affiliation': 'School of Health Sciences, Faculty of Biology, Medicine and Health, University of Manchester, Manchester, UK.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Webb', 'Affiliation': 'Real-World Data and Analytics, GlaxoSmithKline plc., Harlow, UK.'}, {'ForeName': 'Pinal', 'Initials': 'P', 'LastName': 'Patel', 'Affiliation': 'Clinical Statistics (Respiratory), GlaxoSmithKline plc., Uxbridge, UK.'}, {'ForeName': 'Kourtney J', 'Initials': 'KJ', 'LastName': 'Davis', 'Affiliation': 'Real-World Data and Analytics, GlaxoSmithKline plc., Collegeville, PA, USA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Collier', 'Affiliation': 'Respiratory Therapy Area Unit, GlaxoSmithKline plc., Brentford, UK.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Pate', 'Affiliation': 'School of Health Sciences, Faculty of Biology, Medicine and Health, University of Manchester, Manchester, UK.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Leather', 'Affiliation': 'Respiratory Therapy Area Unit, GlaxoSmithKline plc., Brentford, UK.'}, {'ForeName': 'Jeanne M', 'Initials': 'JM', 'LastName': 'Pimenta', 'Affiliation': 'Epidemiology, Global Medical, GlaxoSmithKline plc., Uxbridge, UK.'}]",Pharmacoepidemiology and drug safety,['10.1002/pds.4883'] 240,31443102,Colonization by B. infantis EVC001 modulates enteric inflammation in exclusively breastfed infants.,"BACKGROUND Infant gut dysbiosis, often associated with low abundance of bifidobacteria, is linked to impaired immune development and inflammation-a risk factor for increased incidence of several childhood diseases. We investigated the impact of B. infantis EVC001 colonization on enteric inflammation in a subset of exclusively breastfed term infants from a larger clinical study. METHODS Stool samples (n = 120) were collected from infants randomly selected to receive either 1.8 × 10 10 CFU B. infantis EVC001 daily for 21 days (EVC001) or breast milk alone (controls), starting at day 7 postnatal. The fecal microbiome was analyzed using 16S ribosomal RNA, proinflammatory cytokines using multiplexed immunoassay, and fecal calprotectin using ELISA at three time points: days 6 (Baseline), 40, and 60 postnatal. RESULTS Fecal calprotectin concentration negatively correlated with Bifidobacterium abundance (P < 0.0001; ρ = -0.72), and proinflammatory cytokines correlated with Clostridiaceae and Enterobacteriaceae, yet negatively correlated with Bifidobacteriaceae abundance. Proinflammatory cytokines were significantly lower in EVC001-fed infants on days 40 and 60 postnatally compared to baseline and compared to control infants. CONCLUSION Our findings indicate that gut dysbiosis (absence of B. infantis) is associated with increased intestinal inflammation. Early addition of EVC001 to diet represents a novel strategy to prevent enteric inflammation during a critical developmental phase.",2019,"Proinflammatory cytokines were significantly lower in EVC001-fed infants on days 40 and 60 postnatally compared to baseline and compared to control infants. ","['exclusively breastfed infants', 'Stool samples (n\u2009=\u2009120']","['CFU B. infantis EVC001 daily for 21 days (EVC001) or breast milk alone (controls), starting at day 7 postnatal']","['Proinflammatory cytokines', 'intestinal inflammation', 'fecal microbiome', 'Fecal calprotectin concentration', 'enteric inflammation', 'proinflammatory cytokines']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C1550661', 'cui_str': 'Feces specimen'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}]","[{'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0026140', 'cui_str': 'Breast Milk'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0443281', 'cui_str': 'Postnatal (qualifier value)'}]","[{'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}, {'cui': 'C3889047', 'cui_str': 'Intestinal inflammation'}, {'cui': 'C1956108', 'cui_str': 'Microbiome'}, {'cui': 'C1964053', 'cui_str': 'Faecal calprotectin'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}]",1010.0,0.0603489,"Proinflammatory cytokines were significantly lower in EVC001-fed infants on days 40 and 60 postnatally compared to baseline and compared to control infants. ","[{'ForeName': 'Bethany M', 'Initials': 'BM', 'LastName': 'Henrick', 'Affiliation': 'Evolve Biosystems, Inc, Davis, CA, USA. bhenrick2@unl.edu.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Chew', 'Affiliation': 'Evolve Biosystems, Inc, Davis, CA, USA.'}, {'ForeName': 'Giorgio', 'Initials': 'G', 'LastName': 'Casaburi', 'Affiliation': 'Evolve Biosystems, Inc, Davis, CA, USA.'}, {'ForeName': 'Heather K', 'Initials': 'HK', 'LastName': 'Brown', 'Affiliation': 'Evolve Biosystems, Inc, Davis, CA, USA.'}, {'ForeName': 'Steven A', 'Initials': 'SA', 'LastName': 'Frese', 'Affiliation': 'Evolve Biosystems, Inc, Davis, CA, USA.'}, {'ForeName': 'You', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'Morrison Microscopy Core Research Facility, University of Nebraska, Lincoln, NE, USA.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Underwood', 'Affiliation': 'Foods for Health Institute, University of California Davis, Davis, CA, USA.'}, {'ForeName': 'Jennifer T', 'Initials': 'JT', 'LastName': 'Smilowitz', 'Affiliation': 'Foods for Health Institute, University of California Davis, Davis, CA, USA.'}]",Pediatric research,['10.1038/s41390-019-0533-2'] 241,31590179,Influence of combined treatment with naltrexone and memantine on alcohol drinking behaviors: a phase II randomized crossover trial.,"Glutamate and opioid systems play important roles in alcohol drinking behaviors. We examined if combined treatment with the NMDA antagonist memantine and the opioid antagonist naltrexone, when compared with naltrexone alone, would have a greater influence on alcohol drinking behaviors. Fifty-six, non-treatment-seeking heavy drinkers, with alcohol dependence and a positive family history (FHP) of alcoholism, participated in a randomized, double-blind, crossover trial, including two 6-8 days treatment periods, separated by a 6-day washout, and 3 alcohol drinking paradigm (ADP) sessions. After the first baseline (BAS) ADP1 session, participants were randomized to receive either naltrexone (NTX; 50 mg/day) + placebo memantine, or NTX (50 mg/day) + memantine (MEM; 20 mg/day), during the first treatment period, following which they completed ADP2. After a 6-day washout, participants were crossed over to the treatment they did not receive during the first treatment period, following which they completed ADP3. During each ADP, participants received a priming drink of alcohol followed by 3 1-hour, self-administration periods during which they had ad-lib access to 12 drinks. Individually, both NTX and NTX + MEM, when compared to BAS ADP1, significantly reduced the number of drinks consumed (p's < 0.001) and craving (p's < 0.001). When comparing NTX + MEM vs. NTX on number of drinks consumed, there was a significant treatment* sequence interaction (p = 0.004). Specifically, when NTX + MEM followed NTX alone, NTX + MEM resulted in a further reduction in drinking (mean: -1.94; 95% CI: -2.6, -0.8, p = 0.0005). However, when NTX alone followed NTX + MEM, NTX alone did not lead to further reduction in drinking (mean: 0.59; 95% CI: -0.67, 1.43, p = 0.47). Similar patterns were observed for alcohol craving; specifically, a significant reduction in craving was observed when NTX + MEM followed NTX alone (p = 0.009), but craving reduction was maintained when NTX + MEM was followed by NTX alone. Neither treatment condition significantly influenced alcohol-induced stimulation or sedation. Memantine (at a dose of 20 mg/day) enhances the efficacy of naltrexone (50 mg/day) in reducing alcohol drinking and craving among FHP drinkers with beneficial effects that appear to carryover after discontinuation of memantine treatment.",2020,"When comparing NTX + MEM vs. NTX on number of drinks consumed, there was a significant treatment* sequence interaction (p = 0.004).","['Fifty-six, non-treatment-seeking heavy drinkers, with alcohol dependence and a positive family history (FHP) of alcoholism']","['Memantine', 'naltrexone', 'NTX\u2009+\u2009MEM vs. NTX', 'NMDA antagonist memantine', 'NTX', 'alcohol drinking paradigm (ADP) sessions', 'naltrexone (NTX; 50\u2009mg/day)\u2009+\u2009placebo memantine, or NTX (50\u2009mg/day)\u2009+\u2009memantine (MEM', 'opioid antagonist naltrexone', 'naltrexone and memantine', 'priming drink of alcohol']","['craving', 'alcohol craving', 'alcohol drinking behaviors', 'craving reduction', 'number of drinks consumed', 'alcohol drinking and craving', 'alcohol-induced stimulation or sedation']","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0337678', 'cui_str': 'Heavy drinker (finding)'}, {'cui': 'C0001973', 'cui_str': 'Alcohol Dependence'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0559555', 'cui_str': 'FH - Alcoholism'}]","[{'cui': 'C0025242', 'cui_str': 'Memantine'}, {'cui': 'C0027360', 'cui_str': 'Naltrexone'}, {'cui': 'C1979923', 'cui_str': 'Micro-Electro-Mechanical Systems'}, {'cui': 'C0079883', 'cui_str': 'N-Methyl-D-aspartate'}, {'cui': 'C0243076', 'cui_str': 'antagonists'}, {'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C0439422', 'cui_str': 'mg/day'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0027410', 'cui_str': 'Opioid Receptor Antagonists'}, {'cui': 'C0452428', 'cui_str': 'Drinks (substance)'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}]","[{'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0556385', 'cui_str': 'Craving for alcohol (finding)'}, {'cui': 'C0565662', 'cui_str': 'Finding relating to alcohol drinking behavior'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0452428', 'cui_str': 'Drinks (substance)'}, {'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}]",12.0,0.0285429,"When comparing NTX + MEM vs. NTX on number of drinks consumed, there was a significant treatment* sequence interaction (p = 0.004).","[{'ForeName': 'Suchitra', 'Initials': 'S', 'LastName': 'Krishnan-Sarin', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, Connecticut Mental Health Center, Office S-208, 34 Park Street, New Haven, CT, 06519, USA. suchitra.krishnan-sarin@yale.edu.'}, {'ForeName': 'Stephanie S', 'Initials': 'SS', 'LastName': ""O'Malley"", 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, Connecticut Mental Health Center, Office S-208, 34 Park Street, New Haven, CT, 06519, USA.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Franco', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, Connecticut Mental Health Center, Office S-208, 34 Park Street, New Haven, CT, 06519, USA.'}, {'ForeName': 'Dana A', 'Initials': 'DA', 'LastName': 'Cavallo', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, Connecticut Mental Health Center, Office S-208, 34 Park Street, New Haven, CT, 06519, USA.'}, {'ForeName': 'Jeanette M', 'Initials': 'JM', 'LastName': 'Tetrault', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, Connecticut Mental Health Center, Office S-208, 34 Park Street, New Haven, CT, 06519, USA.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Shi', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, Connecticut Mental Health Center, Office S-208, 34 Park Street, New Haven, CT, 06519, USA.'}, {'ForeName': 'Ralitza', 'Initials': 'R', 'LastName': 'Gueorguieva', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, Connecticut Mental Health Center, Office S-208, 34 Park Street, New Haven, CT, 06519, USA.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Pittman', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, Connecticut Mental Health Center, Office S-208, 34 Park Street, New Haven, CT, 06519, USA.'}, {'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'Krystal', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, Connecticut Mental Health Center, Office S-208, 34 Park Street, New Haven, CT, 06519, USA.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0536-z'] 242,31595716,"A prospective clinical trial of the second-look procedure for transoral surgery in patients with T1 and T2 laryngeal, oropharyngeal, and hypopharyngeal cancer.","BACKGROUND Transoral surgery (TOS) has been widely applied for early T-stage head and neck cancer (HNC). The resection is performed with a minimum safety margin for function preservation under a limited surgical field; therefore, it is difficult to have a strong conviction about the complete resection. This study aims to evaluate the completeness of the initial TOS procedure; possibility of primary control by TOS alone; and predictive factors in patients with early T-stage laryngeal, oropharyngeal, and hypopharyngeal cancer. METHODS Patients were treated by TOS at the primary site with or without neck dissection. The patients were divided into two groups based on the pathological evaluation of their surgical specimens: the control (observation) group, in that the resection was considered complete and the intervention (second-look procedure) group, in that incomplete tumor resection was suspected. The predictive factors for the possibility and/or limitations of complete resection by TOS were then analyzed. RESULTS The study enrolled 26 and 25 patients in the control and intervention group, respectively. The success rate for single resection was 66% and the predictive factor was tumor depth obtained by enhanced computed tomography (CT) examination (odds ratio, 7.870, P = .0243). The success rate for definitive therapy by TOS alone was 83% and the predictive factor was poor differentiation observed on pathological examination (odds ratio, 6.800, P = .0248). CONCLUSIONS TOS has the potential for both definitive resection and function preservation with minimal invasiveness. Identification of the risk factors for TOS is advantageous for accurate treatment selection in patients with early T-stage HNC.",2019,Identification of the risk factors for TOS is advantageous for accurate treatment selection in patients with early T-stage HNC.,"['patients with early T-stage HNC', 'The study enrolled 26 and 25 patients in the control and intervention group, respectively', 'patients with T1 and T2 laryngeal, oropharyngeal, and hypopharyngeal cancer', 'patients with early T-stage laryngeal, oropharyngeal, and hypopharyngeal cancer', 'Patients were treated by TOS at the primary site with or without neck dissection', 'early T-stage head and neck cancer (HNC']","['Transoral surgery (TOS', 'transoral surgery']","['success rate', 'success rate for single resection']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0475455', 'cui_str': 'T category'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0023078', 'cui_str': 'Larynx'}, {'cui': 'C1522409', 'cui_str': 'Oropharyngeal route (qualifier value)'}, {'cui': 'C0153398', 'cui_str': 'Hypopharyngeal Cancer'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0449695', 'cui_str': 'Site of primary lesion (attribute)'}, {'cui': 'C0398395', 'cui_str': 'Neck Dissection'}, {'cui': 'C0278996', 'cui_str': 'Cancer of Head and Neck'}]","[{'cui': 'C0442366', 'cui_str': 'Transoral approach (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}]",,0.0180819,Identification of the risk factors for TOS is advantageous for accurate treatment selection in patients with early T-stage HNC.,"[{'ForeName': 'Goshi', 'Initials': 'G', 'LastName': 'Nishimura', 'Affiliation': 'Department of Otorhinolaryngology, Head and Neck Surgery, School of Medicine, Yokohama City University, Yokohama, Japan.'}, {'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Sano', 'Affiliation': 'Department of Otorhinolaryngology, Head and Neck Surgery, School of Medicine, Yokohama City University, Yokohama, Japan.'}, {'ForeName': 'Yasuhiro', 'Initials': 'Y', 'LastName': 'Arai', 'Affiliation': 'Department of Otorhinolaryngology, Head and Neck Surgery, School of Medicine, Yokohama City University, Yokohama, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Hatano', 'Affiliation': 'Department of Otorhinolaryngology, Head and Neck Surgery, School of Medicine, Yokohama City University, Yokohama, Japan.'}, {'ForeName': 'Hideaki', 'Initials': 'H', 'LastName': 'Takahashi', 'Affiliation': 'Department of Otorhinolaryngology, Head and Neck Surgery, School of Medicine, Yokohama City University, Yokohama, Japan.'}, {'ForeName': 'Teruhiko', 'Initials': 'T', 'LastName': 'Tanabe', 'Affiliation': 'Department of Otorhinolaryngology, Head and Neck Surgery, School of Medicine, Yokohama City University, Yokohama, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Wada', 'Affiliation': 'Department of Otorhinolaryngology, Head and Neck Surgery, School of Medicine, Yokohama City University, Yokohama, Japan.'}, {'ForeName': 'Daiki', 'Initials': 'D', 'LastName': 'Morishita', 'Affiliation': 'Department of Otorhinolaryngology, Head and Neck Surgery, School of Medicine, Yokohama City University, Yokohama, Japan.'}, {'ForeName': 'Nobuhiko', 'Initials': 'N', 'LastName': 'Oridate', 'Affiliation': 'Department of Otorhinolaryngology, Head and Neck Surgery, School of Medicine, Yokohama City University, Yokohama, Japan.'}]",Cancer medicine,['10.1002/cam4.2588'] 243,31944251,Responsiveness and Interpretability of 2 Measures of Physical Function in Patients With Spondyloarthritis.,"BACKGROUND Maintenance or improvement of physical function is an important treatment target in the management of patients with axial spondyloarthritis (axSpA); measurement tools that can detect changes in physical function are therefore important. OBJECTIVES The objective of this study was to compare responsiveness and interpretability of the patient-reported Bath Ankylosing Spondylitis Functional Index (BASFI) and the Ankylosing Spondylitis Performed-Based Improvement (ASPI) in measuring change in physical function after exercise in patients with axSpA. DESIGN This was a sub-study of 58 patients nested within a randomized controlled trial comparing the effect of 12 weeks of exercise with usual care. METHODS Responsiveness and interpretability were assessed according to the Consensus-based Standards for the selection of health status Measurement Instrument. Responsiveness was assessed by testing 8 predefined hypotheses for ASPI and BASFI. Interpretability was assessed by: (1) using patients' reported change as an anchor (""a little better"" = minimal important change) and (2) by categorizing patients with a 20% improvement as responders. RESULTS For ASPI and BASFI, 5 of 8 (63%) versus 2 of 8 (25%) of the predefined hypotheses for responsiveness were confirmed. The minimal important change values for improvement in physical function were 3.7 seconds in ASPI and 0.8 points (on a scale from 0 to 10) for BASFI. In the intervention group, 21 of 30 (70%) and 13 of 30 (43%) of the patients were categorized as responders measured with ASPI and BASFI, respectively. There was a tendency towards a floor effect in BASFI, as 8 of 58 (14%) patients scored the lowest value at baseline. LIMITATIONS This study was limited by its moderate sample size. CONCLUSIONS Our findings suggest that ASPI is preferable over BASFI when evaluating physical function after exercise interventions in patients with axSpA.",2020,"There was a tendency towards a floor effect in BASFI, as 8 of 58 (14%) patients scored the lowest value at baseline. ","['patients with axSpA', 'Patients With Spondyloarthritis', 'patients with axSpA.\nDESIGN', 'patients with axial spondyloarthritis (axSpA', '58 patients nested']","['12-weeks exercise with usual care', 'BASFI', 'ASPI']","['Interpretability', 'responsiveness and interpretability of the patient reported Bath Ankylosing Spondylitis (AS) Functional Index (BASFI']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0949690', 'cui_str': 'Spinal Arthritis'}, {'cui': 'C3203547', 'cui_str': 'Axial spondyloarthritis (disorder)'}]","[{'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0150141'}, {'cui': 'C0038013', 'cui_str': 'Spondylarthritis Ankylopoietica'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",,0.0536311,"There was a tendency towards a floor effect in BASFI, as 8 of 58 (14%) patients scored the lowest value at baseline. ","[{'ForeName': 'Camilla', 'Initials': 'C', 'LastName': 'Fongen', 'Affiliation': 'Department of Rheumatology, National Advisory Unit on Rehabilitation in Rheumatology, Diakonhjemmet Hospital, Oslo, Norway.'}, {'ForeName': 'Hanne', 'Initials': 'H', 'LastName': 'Dagfinrud', 'Affiliation': 'Department of Rheumatology, National Advisory Unit on Rehabilitation in Rheumatology, Diakonhjemmet Hospital.'}, {'ForeName': 'Annelie', 'Initials': 'A', 'LastName': 'Bilberg', 'Affiliation': 'Institute of Neuroscience and Physiology, Section of Health and Rehabilitation, Physiotherapy, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden, and Department of Physiotherapy, Sahlgrenska University Hospital, Gothenburg, Sweden.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Pedersen', 'Affiliation': 'Department of Rheumatology, University Hospital of North Norway, Tromsø, Norway.'}, {'ForeName': 'Melissa Woll', 'Initials': 'MW', 'LastName': 'Johansen', 'Affiliation': 'Department of Rheumatology, Martina Hansens Hospital, Bærum, Norway.'}, {'ForeName': 'Salima', 'Initials': 'S', 'LastName': 'van Weely', 'Affiliation': 'Department of Orthopaedics, Rehabilitation and Physical Therapy, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Kåre Birger', 'Initials': 'KB', 'LastName': 'Hagen', 'Affiliation': 'Department of Rheumatology, National Advisory Unit on Rehabilitation in Rheumatology, Diakonhjemmet Hospital.'}, {'ForeName': 'Silje Halvorsen', 'Initials': 'SH', 'LastName': 'Sveaas', 'Affiliation': 'Department of Rheumatology, National Advisory Unit on Rehabilitation in Rheumatology, Diakonhjemmet Hospital, PO Box 23 Vinderen, 0319 Oslo, Norway.'}]",Physical therapy,['10.1093/ptj/pzaa004'] 244,31944252,A Randomized Controlled Trial Assessing the Evolution of the Weight-Bearing Ankle Dorsiflexion Range of Motion Over 6 Sessions of Talus Mobilizations in Older Adults.,"BACKGROUND Ankle range of motion declines with age, affecting mobility and postural control. OBJECTIVE The objective of this study was to investigate the effects of a talus mobilization-based intervention among healthy community-dwelling older adults presenting with limited weight-bearing ankle dorsiflexion range of motion and determine how ankle mobility evolved over the treatment. DESIGN This was a randomized clinical trial. SETTING This study was conducted in an outpatient clinic. PARTICIPANTS Community-dwelling, older adults over 60 years of age who had limited ankle mobility participated in this study. INTERVENTIONS The experimental intervention consisted of 6 sessions of manual therapy applied in the ankle joint. The control group received the same volume of sham treatment. MEASUREMENTS The primary outcome was the weight-bearing ankle dorsiflexion range of motion as measured using the lunge test. Data were collected at 9 time points: baseline, after each session, and follow-up. RESULTS A total of 36 participants were analyzed. A single session of mobilization increased ankle range of motion by 8 degrees (95% confidence interval = 6 to 11). At the end of the sixth session, this effect had increased slightly to 11 degrees (95% confidence interval = 9 to 13). Significant between-group differences were found throughout the intervention. LIMITATIONS Optimal dose and effects from follow-up evaluations for treatment volumes of fewer than 6 sessions remain unknown. CONCLUSIONS Six sessions of a talus mobilization-based intervention in healthy community-dwelling older adults found that the greatest mobility gain in terms of the weight-bearing ankle dorsiflexion range of motion is produced after the first session. Additional sessions produce smaller improvements with a slight upward trend. Importantly, the restoration of joint mobility is enhanced over time after the end of the intervention.",2020,The primary outcome was the weight-bearing ankle dorsiflexion range of motion as measured using the lunge test.,"['Thirty-six participants were analyzed', 'Older Adults', 'outpatient clinic', 'healthy community-dwelling older adults presenting with limited weight-bearing ankle dorsiflexion range of motion', 'healthy community-dwelling older adults', 'Community-dwelling, older adults over age 60 who had limited ankle mobility participated in this study']","['Weight-Bearing Ankle Dorsiflexion Range of Motion', 'talus mobilization-based intervention']","['weight-bearing ankle dorsiflexion range of motion as measured using the lunge test', 'joint mobility']","[{'cui': 'C4319606', 'cui_str': 'Thirty-six'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0002424', 'cui_str': 'Outpatient Clinics'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0085086', 'cui_str': 'Finding of weight-bearing'}, {'cui': 'C0003086', 'cui_str': 'Regio tarsalis'}, {'cui': 'C0080078', 'cui_str': 'Range of Motion'}, {'cui': 'C4045975', 'cui_str': 'Community Dwelling'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439801', 'cui_str': 'Limited (qualifier value)'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0085086', 'cui_str': 'Finding of weight-bearing'}, {'cui': 'C0003086', 'cui_str': 'Regio tarsalis'}, {'cui': 'C0080078', 'cui_str': 'Range of Motion'}, {'cui': 'C0039277', 'cui_str': 'Astragalus Bone'}, {'cui': 'C0300926', 'cui_str': 'mobilization'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0085086', 'cui_str': 'Finding of weight-bearing'}, {'cui': 'C0003086', 'cui_str': 'Regio tarsalis'}, {'cui': 'C0080078', 'cui_str': 'Range of Motion'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0022417', 'cui_str': 'Joints'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}]",36.0,0.100207,The primary outcome was the weight-bearing ankle dorsiflexion range of motion as measured using the lunge test.,"[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Hernández-Guillén', 'Affiliation': 'Group in Physiotherapy in the Ageing Process, Social and Health Care Strategies, Department of Physiotherapy, University of Valencia, Calle Gascó Oliag 5, 46010 Valencia, Spain.'}, {'ForeName': 'José-María', 'Initials': 'JM', 'LastName': 'Blasco', 'Affiliation': 'Group in Physiotherapy in the Ageing Process, Social and Health Care Strategies, Department of Physiotherapy, University of Valencia.'}]",Physical therapy,['10.1093/ptj/pzaa003'] 245,31486777,Magnetic seizure therapy (MST) for major depressive disorder.,"Electroconvulsive therapy (ECT) is effective for major depressive disorder (MDD) but its effects on memory limit its widespread use. Magnetic seizure therapy (MST) is a potential alternative to ECT that may not adversely affect memory. In the current trial, consecutive patients with MDD consented to receive MST applied over the prefrontal cortex according to an open-label protocol. Depressive symptoms and cognition were assessed prior to, during and at the end of treatment. Patients were treated two to three times per week with high-frequency MST (i.e., 100 Hz) (N = 24), medium frequency MST (i.e., 60 or 50 Hz) (N = 26), or low-frequency MST (i.e., 25 Hz MST) (N = 36) using 100% stimulator output. One hundred and forty patients were screened; 86 patients with MDD received a minimum of eight treatments and were deemed to have an adequate course of MST; and 47 completed the trial per protocol, either achieving remission (i.e., 24-item Hamilton Rating Scale for Depression score <10 and a relative reduction of >60% at two consecutive assessments; n = 17) or received a maximum of 24 sessions (n = 30). High-frequency (100 Hz) MST produced the highest remission rate (33.3%). Performance on most cognitive measures remained stable, with the exception of significantly worsened recall consistency of autobiographical information and significantly improved brief visuospatial memory task performance. Under open conditions, MST led to clinically meaningful reduction in depressive symptoms in patients with MDD and produced minimal cognitive impairment. Future studies should compare MST and ECT under double-blind randomized condition.",2020,"Performance on most cognitive measures remained stable, with the exception of significantly worsened recall consistency of autobiographical information and significantly improved brief visuospatial memory task performance.","['consecutive patients with MDD consented to receive', 'major depressive disorder', 'One hundred and forty patients were screened; 86 patients with MDD received a minimum of eight treatments and were deemed to have an adequate course of MST; and 47 completed the trial per protocol, either achieving remission (i.e., 24-item Hamilton Rating Scale for Depression score <10 and a relative reduction of >60% at two consecutive assessments; n\u2009=\u200917) or received a maximum of 24 sessions (n\u2009=\u200930']","['Magnetic seizure therapy (MST', 'Electroconvulsive therapy (ECT', 'MST']","['depressive symptoms', 'High-frequency', 'Depressive symptoms and cognition', 'minimal cognitive impairment', 'highest remission rate', 'brief visuospatial memory task performance']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205411', 'cui_str': 'Adequate (qualifier value)'}, {'cui': 'C0750729', 'cui_str': 'Courses (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C4545802', 'cui_str': 'HAM-D (Hamilton Rating Scale for Depression) score'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]","[{'cui': 'C0024488', 'cui_str': 'Magnetics'}, {'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0013806', 'cui_str': 'Electroshock Therapy'}]","[{'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0205212', 'cui_str': 'High frequency (qualifier value)'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C1291708', 'cui_str': 'Minimal cognitive impairment'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0039333', 'cui_str': 'Task Performance'}]",140.0,0.0334955,"Performance on most cognitive measures remained stable, with the exception of significantly worsened recall consistency of autobiographical information and significantly improved brief visuospatial memory task performance.","[{'ForeName': 'Zafiris J', 'Initials': 'ZJ', 'LastName': 'Daskalakis', 'Affiliation': 'Centre for Addiction and Mental Health, Department of Psychiatry, University of Toronto, Toronto, ON, Canada. Jeff.Daskalakis@camh.ca.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Dimitrova', 'Affiliation': 'Centre for Addiction and Mental Health, Department of Psychiatry, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Shawn M', 'Initials': 'SM', 'LastName': 'McClintock', 'Affiliation': 'Neurocognitive Research Laboratory, Department of Psychiatry, University of Texas Southwestern Medical Center, and Department of Psychiatry and Behavioral Sciences, Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Yinming', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'Centre for Addiction and Mental Health, Department of Psychiatry, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Daphne', 'Initials': 'D', 'LastName': 'Voineskos', 'Affiliation': 'Centre for Addiction and Mental Health, Department of Psychiatry, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Tarek K', 'Initials': 'TK', 'LastName': 'Rajji', 'Affiliation': 'Centre for Addiction and Mental Health, Department of Psychiatry, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Goldbloom', 'Affiliation': 'Centre for Addiction and Mental Health, Department of Psychiatry, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Albert H C', 'Initials': 'AHC', 'LastName': 'Wong', 'Affiliation': 'Centre for Addiction and Mental Health, Department of Psychiatry, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Yuliya', 'Initials': 'Y', 'LastName': 'Knyahnytska', 'Affiliation': 'Centre for Addiction and Mental Health, Department of Psychiatry, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Benoit H', 'Initials': 'BH', 'LastName': 'Mulsant', 'Affiliation': 'Centre for Addiction and Mental Health, Department of Psychiatry, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Downar', 'Affiliation': 'Toronto General Hospital, University Health Network, Department of Psychiatry, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Paul B', 'Initials': 'PB', 'LastName': 'Fitzgerald', 'Affiliation': 'Epworth Centre for Innovation in Mental Health, Epworth Healthcare and Monash Alfred Psychiatry Research Centre, The Alfred and Monash University Central Clinical School, Commercial Rd Melbourne, VIC, Australia.'}, {'ForeName': 'Daniel M', 'Initials': 'DM', 'LastName': 'Blumberger', 'Affiliation': 'Centre for Addiction and Mental Health, Department of Psychiatry, University of Toronto, Toronto, ON, Canada.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0515-4'] 246,32147873,Application of inter-professional care model in patients with aneurysmal subarachnoid haemorrhage.,"OBJECTIVE To explore the feasibility and effect of the inter-professional care model in patients with aneurysmal subarachnoid haemorrhage. METHODS A convenient sampling method was used to recruit inpatients of a hospital as subjects from July 2016 to July 2018. According to the even/odd attribute of admission number, subjects were divided into a control group and an observation group. The number of recruited subjects was 311: the control group comprised 135 participants and the observation group 176. The average length of hospital stay, hospital fees, quality of life, and satisfaction with the quality of nursing were compared between the two groups. SPIRIT checklist was completed (see File S1). RESULTS After intervention, patients in the observation group had shorter average hospital stay (15.98 ± 2.7), lower hospital fees (81,018 ± 1.3), higher satisfaction with the quality of nursing (98.3%), lower incidence of complications (19.89%), improved ability to perform activities of daily living, and lower rate of disease outcome and re-admission, with statistically significant differences from the control group (p < .05). CONCLUSION The application of inter-professional care model in single disease patients with aneurysmal subarachnoid haemorrhage can shorten the average hospital stay, reduce hospital fees, improve the quality of life of patients, and increase patients' satisfaction with the quality of nursing, which is worthy of clinical promotion and application. IMPLICATIONS FOR NURSING MANAGEMENT SECTION Nursing managers can use this model to improve the ability to ensure coordination between medical professionals and integrate the ability of nursing problems, the ability to make rational distribution of nursing human resources, and the ability of critical thinking. It can be used as reference to improve the nursing management of all kinds of single diseases.",2020,"After intervention, patients in the observation group had shorter average hospital stay (15.98±2.7), lower hospital fees (81018±1.3), higher satisfaction with the quality of nursing (98.3%), lower incidence of complications (19.89%), improved ability to perform activities of daily living , and lower rate of disease outcome and re-admission, with statistically significant differences from the control group (p < 0.05). ","['patients with aneurysmal subarachnoid hemorrhage', 'single disease patients with aneurysmal subarachnoid hemorrhage', 'recruit inpatients of a hospital as subjects from July 2016 to July 2018', '176']",['observation group'],"['incidence of complications', 'lower hospital fees', 'ability to perform activities of daily living , and lower rate of disease outcome and re-admission', 'average length of hospital stay, hospital fees, quality of life, and satisfaction with the quality of nursing', 'shorter average hospital stay', 'higher satisfaction with the quality of nursing']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0751530', 'cui_str': 'Subarachnoid Hemorrhage, Aneurysmal'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}]","[{'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0015751', 'cui_str': 'Fees'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0001288', 'cui_str': 'ADL'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0034380'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0028678', 'cui_str': 'nursing care'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]",,0.0158111,"After intervention, patients in the observation group had shorter average hospital stay (15.98±2.7), lower hospital fees (81018±1.3), higher satisfaction with the quality of nursing (98.3%), lower incidence of complications (19.89%), improved ability to perform activities of daily living , and lower rate of disease outcome and re-admission, with statistically significant differences from the control group (p < 0.05). ","[{'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': ""Shanxi People's Hospital, Taiyuan, China.""}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'Graduate School of Shanxi, University of Traditional Chinese Medicine, Taiyuan, China.'}, {'ForeName': 'Haihua', 'Initials': 'H', 'LastName': 'Yan', 'Affiliation': ""Shanxi People's Hospital, Taiyuan, China.""}]",Journal of nursing management,['10.1111/jonm.12993'] 247,32149954,Ingenol Mebutate Gel 0.05% in the Treatment of Anogenital Warts: A Prospective Controlled Trial Comparing It With Topical Podophyllin Solution 25.,"BACKGROUND Anogenital warts (AGWs) are a common therapeutic challenge. All therapies are associated with burning, pain, and frustrating high rate of recurrence. The search for a new alternative continues. Recently, a diterpene ester extracted from the Euphorbia peplus plant (ingenol mebutate [IM]) has been shown to possess activity against AGWs. OBJECTIVE This study aimed to compare and evaluate the therapeutic efficacy and safety of topical 0.05% ingenol gel with another herbal extract medication (topical 25% podophyllin solution) in treatment of AGWs. METHODS This was a comparative single blinded nonrandomized, 2-arm trial of ingenol 0.05% gel versus podophyllin solution 25% administered up to 6 times to patients with AGWs. To evaluate the therapeutic efficacy, the complete clearance rate and recurrence rate were assessed 1 and 12 weeks after last treatment, respectively. Safety was assessed by occurrence and severity of pain and local skin reaction (LSR). RESULTS Of 31 and 36 patients in the IM group and podophyllin group who completed the study, initial complete resolution was observed in 20 (64.5%) and 14 (38.9%) patients, respectively (P = 0.03). The initial clearance was faster in the IM group (2.00 ± 0.91 weeks) compared with the podophyllin group (4.21 ± 1.05 weeks, P = 0.00). After 3 months, recurrence was seen in 13 (65.0%) of 20 patients in the IM group and 6 (42.8%) of 14 in the podophyllin group (P = 0.20). The number of patients with complete resolution after 3 months was not different between the 2 groups (7/31 in the IM group and 8/36 in the podophyllin group, P = 0.97). The mean ± SD severity scores for LSR and pain in the IM group were 6.65 ± 1.76 and 6.13 ± 2.57, respectively, which was significantly higher than their scores (3.39 ± 1.57 and 2.58 ± 1.38) in the podophyllin group (P = 0.00). CONCLUSION Ingenol mebutate 0.05% gel is effective as podophyllin 25% solution in treating AGWs, with further benefit of being much more rapid. However, high recurrence rate, sever pain, and LSR limit its use.",2020,"After 3 months, recurrence was seen in 13/20 (65.0%) patients in IM group and 6/14 (42.8%) in podophyllin group, P=0.20.The number of patients with complete resolution after 3 months was not different between two groups ( 7/31 in IM group and 8/36 in podophyllin group, P=0.9).","['patients with AGWs', 'anogenital warts', 'Out of 31 and 36 patients in IM group and podophyllin group who completed the study']","['topical podophyllin solution', 'topical .05% ingenol gel with another herbal extract medication ( topical 25% podophyllin solution', 'Ingenol .05% gel versus podophyllin solution']","['mean±SD severity score for LSR and pain', 'occurrence and severity of pain and local skin reaction (LSR', 'initial complete resolution', 'high recurrence rate, sever pain and local skin reaction limit', 'therapeutic efficacy', 'initial clearance', 'therapeutic efficacy and safety', 'clearance rate and recurrence rate', 'recurrence']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0043237', 'cui_str': 'WHO'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0032333', 'cui_str': 'podophyllum resin'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}, {'cui': 'C0063537', 'cui_str': 'ingenol'}, {'cui': 'C0017243', 'cui_str': 'Gel (basic dose form)'}, {'cui': 'C0376667', 'cui_str': 'Herbal'}, {'cui': 'C2752151', 'cui_str': 'Extract (qualifier value)'}]","[{'cui': 'C0457451', 'cui_str': 'Severity score (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0221743', 'cui_str': 'Skin reaction (observable entity)'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0439801', 'cui_str': 'Limited (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.0469115,"After 3 months, recurrence was seen in 13/20 (65.0%) patients in IM group and 6/14 (42.8%) in podophyllin group, P=0.20.The number of patients with complete resolution after 3 months was not different between two groups ( 7/31 in IM group and 8/36 in podophyllin group, P=0.9).","[{'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Shahidi Dadras', 'Affiliation': 'From the Skin Research Center, Shahid Beheshti University of Medical Sciences.'}, {'ForeName': 'Zeinab', 'Initials': 'Z', 'LastName': 'Bizaval', 'Affiliation': 'From the Skin Research Center, Shahid Beheshti University of Medical Sciences.'}, {'ForeName': 'Mahmood', 'Initials': 'M', 'LastName': 'Hoormand', 'Affiliation': 'Department of Pharmacology, School of Medicine, Iran University of Medical Sciences.'}, {'ForeName': 'Nikoo', 'Initials': 'N', 'LastName': 'Mozafari', 'Affiliation': 'From the Skin Research Center, Shahid Beheshti University of Medical Sciences.'}]",Sexually transmitted diseases,['10.1097/OLQ.0000000000001165'] 248,31274189,Primaquine at alternative dosing schedules for preventing relapse in people with Plasmodium vivax malaria.,"BACKGROUND Malaria caused by Plasmodium vivax requires treatment of the blood-stage infection and treatment of the hypnozoites that develop in the liver. This is a challenge to effective case management of P vivax malaria, as well as being a more general substantial impediment to malaria control. The World Health Organization (WHO) recommends a 14-day drug course with primaquine, an 8-aminoquinoline, at 0.25 mg/kg/day in most of the world (standard course), or 0.5 mg/kg/day in East Asia and Oceania (high-standard course). This long treatment course can be difficult to complete, and primaquine can cause dangerous haemolysis in individuals with glucose-6-phosphate dehydrogenase (G6PD) deficiency, meaning that physicians may be reluctant to prescribe in areas where G6PD testing is not available. This Cochrane Review evaluated whether more patient-friendly alternative regimens are as efficacious as the standard regimen for radical cure ofP vivax malaria. OBJECTIVES To assess the efficacy and safety of alternative primaquine regimens for radical cure of P vivax malaria compared to the standard or high-standard 14 days of primaquine (0.25 or 0.5 mg/kg/day), as well as comparison of these two WHO-recommended regimens. SEARCH METHODS We searched the Cochrane Infectious Diseases Group (CIDG) Specialized Register; the Cochrane Central Register of Controlled Trials (CENTRAL); MEDLINE (PubMed); Embase (Ovid); and LILACS (BIREME) up to 17 December 2018. We also searched the WHO International Clinical Trials Registry Platform (ICTRP) and ClinicalTrials.gov, and checked the reference lists of all studies identified by the above methods. SELECTION CRITERIA Randomized controlled trials (RCTs) of adults and children with P vivax malaria using any regimen of either chloroquine or an artemisinin-based combination therapy (ACT) plus primaquine with either higher daily doses for 14 days, shorter regimens with the same total dose, or using weekly dosing regimens; compared with the usual standard regimens recommended by the WHO (0.25 or 0.5 mg/kg/day for 14 days), or a comparison of these two WHO-recommended regimens. DATA COLLECTION AND ANALYSIS Two review authors independently assessed trial eligibility and quality, and extracted data. We calculated risk ratios (RRs) with 95% confidence intervals (CIs) for dichotomous data. We grouped efficacy data according to length of follow-up. We analysed safety data where this information was included. MAIN RESULTS High-standard 14-day course versus standard 14-day courseTwo RCTs compared the high-standard 14-day regimen with the standard 14-day regimen. People with G6PD deficiency and pregnant or lactating women were excluded. We do not know if there is any difference in P vivax recurrences at 6 months with 0.5 mg/kg/day primaquine therapy for 14 days compared to 0.25 mg/kg/day primaquine therapy for 14 days (with chloroquine: RR 0.82, 95% CI 0.47 to 1.43, 639 participants, very low-certainty evidence; with chloroquine or an ACT: RR 1.11, 95% CI 0.17 to 7.09, 38 participants, very low-certainty evidence). No serious adverse events were reported. We do not know whether there is a difference in adverse events with the higher dosage (very low-certainty evidence).0.5 mg/kg/day primaquine for 7 days versus standard 14-day courseFive RCTs compared 0.5 mg/kg/day primaquine for 7 days with the standard 14-day course. There may be little or no difference in P vivax recurrences at 6 to 7 months when using the same total dose (0.5 mg/kg/day to 210 mg) over 7 days as compared to 14 days (RR 0.96, 95% CI 0.66 to 1.39; 1211 participants; low-certainty evidence). No serious adverse events were reported. There may be little or no difference in the number of adverse events known to occur with primaquine between the primaquine shorter regimen as compared to the longer regimen (RR 1.06, 95% CI 0.64 to 1.76; 1154 participants; low-certainty evidence). We do not know whether there is any difference in the frequency of anaemia or discontinuation of treatment between groups (very low-certainty evidence). Three trials excluded people with G6PD deficiency, and two did not provide this information. Pregnant and lactating women were either excluded or no details were provided regarding their inclusion or exclusion.0.75 mg/kg primaquine/week for 8 weeks versus high-standard course One RCT compared weekly primaquine with the high-standard 14-day course. G6PD-deficient patients were not randomized but were included in the weekly primaquine group. Only one G6PD-deficient participant was detected during the trial. We do not know whether weekly primaquine increases or decreases recurrences of P vivax compared to the 14-day regimen at 11 months' follow-up (RR 3.18, 95% CI 0.37 to 27.6; 122 participants; very low-certainty evidence). No serious adverse events and no episodes of anaemia were reported.Three other RCTs evaluated different alternative regimens and doses of primaquine, but one of these RCTs did not have results available, and two used regimens that have not been widely used and the evidence was of very low certainty. AUTHORS' CONCLUSIONS Although limited data were available, the analysis did not detect a difference in recurrence between the 7-day regimen and the standard 14-day regimen of 0.5 mg/kg/day primaquine, and no serious adverse events were reported in G6PD-normal participants taking 0.5 mg/kg/day of primaquine. This shorter regimen may be useful in G6PD-normal patients if there are treatment adherence concerns. Further large high-quality RCTs are needed, such as the IMPROV trial, with more standardised comparison regimens and longer follow-up to help resolve uncertainties.",2019,"There may be little or no difference in P vivax recurrences at 6 to 7 months when using the same total dose (0.5 mg/kg/day to 210 mg) over 7 days as compared to 14 days (RR 0.96, 95% CI 0.66 to 1.39; 1211 participants; low-certainty evidence).","['adults and children with P vivax malaria using any regimen of either', 'G6PD-deficient patients', 'people with Plasmodium vivax malaria', 'People with G6PD deficiency and pregnant or lactating women', 'individuals with glucose-6-phosphate dehydrogenase (G6PD) deficiency', 'Pregnant and lactating women']","['Cochrane Infectious Diseases Group (CIDG', 'primaquine, an 8-aminoquinoline', 'Primaquine', 'chloroquine or an artemisinin-based combination therapy (ACT) plus primaquine', 'chloroquine: RR', 'chloroquine', 'primaquine']","['recurrence', 'calculated risk ratios (RRs', 'radical cure of P vivax malaria', 'serious adverse events and no episodes of anaemia', 'P vivax recurrences', 'efficacy and safety', 'serious adverse events', 'recurrences of P vivax']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0024537', 'cui_str': 'Plasmodium vivax Malaria'}, {'cui': 'C0011155', 'cui_str': 'Deficient (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2939465', 'cui_str': 'GPD Deficiency'}, {'cui': 'C0549206', 'cui_str': 'Pregnancy not delivered'}, {'cui': 'C0202115', 'cui_str': 'Lactic acid measurement (procedure)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C1273849', 'cui_str': 'Infectious Diseases Specialty'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0033126', 'cui_str': 'Primaquine'}, {'cui': 'C0658114', 'cui_str': '8-aminoquinoline'}, {'cui': 'C0008269', 'cui_str': 'Chloroquine'}, {'cui': 'C1136174', 'cui_str': 'Artemisinins'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0556895', 'cui_str': 'Combination therapy (regime/therapy)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0028873', 'cui_str': 'Risk Ratio'}, {'cui': 'C0439807', 'cui_str': 'Radical - extent'}, {'cui': 'C0024537', 'cui_str': 'Plasmodium vivax Malaria'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.139455,"There may be little or no difference in P vivax recurrences at 6 to 7 months when using the same total dose (0.5 mg/kg/day to 210 mg) over 7 days as compared to 14 days (RR 0.96, 95% CI 0.66 to 1.39; 1211 participants; low-certainty evidence).","[{'ForeName': 'Rachael', 'Initials': 'R', 'LastName': 'Milligan', 'Affiliation': 'Cochrane Infectious Diseases Group, Liverpool School of Tropical Medicine, Pembroke Place, Liverpool, UK, L3 5QA.'}, {'ForeName': 'André', 'Initials': 'A', 'LastName': 'Daher', 'Affiliation': ''}, {'ForeName': 'Patricia M', 'Initials': 'PM', 'LastName': 'Graves', 'Affiliation': ''}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD012656.pub2'] 249,31514201,The effect of methylphenidate on social cognition and oxytocin in children with attention deficit hyperactivity disorder.,"The current study aimed to explore the possible effect of stimulants on oxytocin (OT), a neuropeptide which regulates social behavior, as a mediator of the pro-social effect of methylphenidate (MPH) in children with attention deficit hyperactivity disorder (ADHD) compared to healthy controls (HCs). Utilizing a double-blind placebo-controlled design, we compared the performance of 50 children with ADHD and 40 HCs in ""theory of mind"" (ToM) tasks and examined the effect of a single dose of MPH/placebo on ToM and salivary OT levels in children with ADHD at baseline and following an interpersonal interaction. Children with ADHD displayed significantly poorer ToM performance; however, following MPH administration, their performance normalized and differences between children with ADHD and HC were no longer found. Salivary OT levels at baseline did not differ between children with ADHD and HCs. However, after a parent-child interaction, OT levels were significantly higher in the HC group compared to children with ADHD. Administration of MPH attenuated this difference such that after parent-child interaction differences in OT levels between children with ADHD and HC were no longer found. In the ADHD group, OT levels decreased from administration of placebo to the parent-child interaction. However, the administration of MPH to children with ADHD was associated with an increase in OT levels after the parent-child interaction. We conclude that OT might play a role as a mediator of social deficits in children with ADHD and that the reactivity of the OT system to social interaction in children with ADHD might be impaired. Stimulants may improve ToM and social functions in children with ADHD via its impact on the OT system. PRS: OT and Social Cognition in Children with ADHD: Impact of MPH.",2020,"However, after a parent-child interaction, OT levels were significantly higher in the HC group compared to children with ADHD.","['Children with ADHD', 'children with attention deficit hyperactivity disorder (ADHD', '50 children with ADHD and 40 HCs in ""theory of mind"" (ToM) tasks', 'children with ADHD at baseline and following an interpersonal interaction', 'children with attention deficit hyperactivity disorder', 'children with ADHD']","['methylphenidate', 'HC', 'MPH', 'MPH/placebo', 'oxytocin (OT', 'placebo', 'methylphenidate (MPH']","['ToM and social functions', 'poorer ToM performance', 'Salivary OT levels', 'social cognition and oxytocin', 'ToM and salivary OT levels', 'OT levels']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C0935573', 'cui_str': 'Mentalizing'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}]","[{'cui': 'C0025810', 'cui_str': 'Methylphenidate'}, {'cui': 'C0048853', 'cui_str': 'MPH'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}]","[{'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0442040', 'cui_str': 'Salivary (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}]",50.0,0.04804,"However, after a parent-child interaction, OT levels were significantly higher in the HC group compared to children with ADHD.","[{'ForeName': 'Orit', 'Initials': 'O', 'LastName': 'Levi-Shachar', 'Affiliation': 'Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Hila Z', 'Initials': 'HZ', 'LastName': 'Gvirts', 'Affiliation': 'Department of Behavioral Sciences and Psychology, Ariel University, Ariel, Israel.'}, {'ForeName': 'Yiftach', 'Initials': 'Y', 'LastName': 'Goldwin', 'Affiliation': 'Shalvata Mental Health Center, Hod-Hasharon, Israel.'}, {'ForeName': 'Yuval', 'Initials': 'Y', 'LastName': 'Bloch', 'Affiliation': 'Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Shamay-Tsoory', 'Affiliation': 'Department of Psychology, Haifa University, Haifa, Israel.'}, {'ForeName': 'Orna', 'Initials': 'O', 'LastName': 'Zagoory-Sharon', 'Affiliation': 'Baruch Ivcher School of Psychology, Interdisciplinary Center, Herzlia, Israel.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Feldman', 'Affiliation': 'Baruch Ivcher School of Psychology, Interdisciplinary Center, Herzlia, Israel.'}, {'ForeName': 'Hagai', 'Initials': 'H', 'LastName': 'Maoz', 'Affiliation': 'Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel. hagaima@gmail.com.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0522-5'] 250,32171774,The Impact of Levothyroxine on Cardiac Function in Older Adults With Mild Subclinical Hypothyroidism: A Randomized Clinical Trial.,"BACKGROUND Subclinical hypothyroidism has been associated with heart failure, but only small trials assessed whether treatment with levothyroxine has an impact on cardiac function. METHODS In a randomized, double-blind, placebo-controlled, trial nested within the TRUST trial, Swiss participants ages ≥65 years with subclinical hypothyroidism (thyroid-stimulating hormone [TSH] 4.60-19.99 mIU/L; free thyroxine level within reference range) were randomized to levothyroxine (starting dose of 50 µg daily) to achieve TSH normalization or placebo. The primary outcomes were the left ventricular ejection fraction for systolic function and the ratio between mitral peak velocity of early filling to early diastolic mitral annular velocity (E/e' ratio) for diastolic function. Secondary outcomes included e' lateral/septal, left atrial volume index, and systolic pulmonary artery pressure. RESULTS A total of 185 participants (mean age 74.1 years, 47% women) underwent echocardiography at the end of the trial. After a median treatment duration of 18.4 months, the mean TSH decreased from 6.35 mIU/L to 3.55 mIU/L with levothyroxine (n = 96), and it remained elevated at 5.29 mIU/L with placebo (n = 89). The adjusted between-group difference was not significant for the mean left ventricular ejection fraction (62.7% vs 62.5%, difference = 0.4%, 95% confidence interval -1.8% to 2.5%, P = 0.72) and the E/e' ratio (10.6 vs 10.1, difference 0.4, 95% confidence interval -0.7 to 1.4, P = 0.47). No differences were found for the secondary diastolic function parameters or for interaction according to sex, baseline TSH, preexisting heart failure, and treatment duration (P value >0.05). CONCLUSION Systolic and diastolic heart function did not differ after treatment with levothyroxine compared with placebo in older adults with mild subclinical hypothyroidism.",2020,"No differences were found for the secondary diastolic function parameters, nor for interaction according to sex, baseline TSH, preexisting heart failure and treatment duration (P-value >0.05). ","['mean age 74.1 years, 47% women) underwent', '185 participants ', 'Older Adults with Mild Subclinical Hypothyroidism', 'older adults with mild subclinical hypothyroidism', 'Swiss participants aged ≥65 years with subclinical hypothyroidism (thyroid-stimulating hormone, TSH, 4.60-19.99 mIU/L; free thyroxine level within reference range']","['TSH normalization, or placebo', 'placebo', 'Levothyroxine', 'echocardiography', 'levothyroxine']","[""e' lateral/septal, left atrial volume index and systolic pulmonary artery pressure"", 'mean TSH', 'mean left ventricular ejection fraction', 'secondary diastolic function parameters, nor for interaction according to sex, baseline TSH, preexisting heart failure and treatment duration', 'Cardiac Function', ""left ventricular ejection fraction for systolic function, and the ratio between mitral peak velocity of early filling to early diastolic mitral annular velocity (E/e' ratio) for diastolic function"", 'Systolic and diastolic heart function']","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C4517617', 'cui_str': '185 (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0271790', 'cui_str': 'Subclinical hypothyroidism (disorder)'}, {'cui': 'C0241315', 'cui_str': 'Swiss (ethnic group)'}, {'cui': 'C0040134', 'cui_str': 'thyroid (USP)'}, {'cui': 'C0019932', 'cui_str': 'Hormones'}, {'cui': 'C0202230', 'cui_str': 'Thyroid stimulating hormone measurement (procedure)'}, {'cui': 'C0439462', 'cui_str': 'milliinternational unit/liter'}, {'cui': 'C0312452', 'cui_str': 'Free thyroxin (substance)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0460094', 'cui_str': 'Within reference range (qualifier value)'}]","[{'cui': 'C0202230', 'cui_str': 'Thyroid stimulating hormone measurement (procedure)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1881373', 'cui_str': ""L-3,5,3',5'-Tetraiodothyronine""}, {'cui': 'C0013516', 'cui_str': 'Transthoracic Echocardiography'}]","[{'cui': 'C0205093', 'cui_str': 'Lateral (qualifier value)'}, {'cui': 'C0442004', 'cui_str': 'Septal (qualifier value)'}, {'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428642', 'cui_str': 'Pulmonary artery pressure (observable entity)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0202230', 'cui_str': 'Thyroid stimulating hormone measurement (procedure)'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction (observable entity)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0232164', 'cui_str': 'Cardiac function (observable entity)'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0521164', 'cui_str': 'Annular shape (qualifier value)'}, {'cui': 'C4521692', 'cui_str': 'Cardiac physiological function (observable entity)'}]",185.0,0.763923,"No differences were found for the secondary diastolic function parameters, nor for interaction according to sex, baseline TSH, preexisting heart failure and treatment duration (P-value >0.05). ","[{'ForeName': 'Baris', 'Initials': 'B', 'LastName': 'Gencer', 'Affiliation': ""Service of Cardiology, University Hospitals of Geneva, University of Geneva, Switzerland; TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, United States.""}, {'ForeName': 'Elisavet', 'Initials': 'E', 'LastName': 'Moutzouri', 'Affiliation': 'Institute of Primary Health Care (BIHAM), University of Bern, Bern, Switzerland; Department of General Internal Medicine, Inselspital, Bern University Hospital, University of Bern, Switzerland.'}, {'ForeName': 'Manuel R', 'Initials': 'MR', 'LastName': 'Blum', 'Affiliation': 'Department of General Internal Medicine, Inselspital, Bern University Hospital, University of Bern, Switzerland; Department of Health Research & Policy, Stanford University School of Medicine, Stanford, Calif.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Feller', 'Affiliation': 'Institute of Primary Health Care (BIHAM), University of Bern, Bern, Switzerland; Department of General Internal Medicine, Inselspital, Bern University Hospital, University of Bern, Switzerland.'}, {'ForeName': 'Tinh-Hai', 'Initials': 'TH', 'LastName': 'Collet', 'Affiliation': 'Service of Endocrinology, Diabetes and Metabolism, Department of Medicine, Lausanne University Hospital, University of Lausanne, Switzerland.'}, {'ForeName': 'Cinzia', 'Initials': 'C', 'LastName': 'Delgiovane', 'Affiliation': 'Institute of Primary Health Care (BIHAM), University of Bern, Bern, Switzerland.'}, {'ForeName': 'Bruno R', 'Initials': 'BR', 'LastName': 'da Costa', 'Affiliation': ""Institute of Primary Health Care (BIHAM), University of Bern, Bern, Switzerland; Applied Health Research Centre (AHRC), Li Ka Shing Knowledge Institute of St. Michael's Hospital, Institute of Health Policy, Management, and Evaluation, University of Toronto, Toronto, Ontario, Canada.""}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Buffle', 'Affiliation': 'Department of Cardiology, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Monney', 'Affiliation': 'Service of Cardiology, Department of Heart and Vessels, Lausanne University Hospital, University of Lausanne, Switzerland.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Gabus', 'Affiliation': 'Service of Cardiology, Department of Heart and Vessels, Lausanne University Hospital, University of Lausanne, Switzerland.'}, {'ForeName': 'Hajo', 'Initials': 'H', 'LastName': 'Müller', 'Affiliation': 'Service of Cardiology, University Hospitals of Geneva, University of Geneva, Switzerland.'}, {'ForeName': 'Gerasimos P', 'Initials': 'GP', 'LastName': 'Sykiotis', 'Affiliation': 'Service of Endocrinology, Diabetes and Metabolism, Department of Medicine, Lausanne University Hospital, University of Lausanne, Switzerland.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Kearney', 'Affiliation': 'University College Cork, Cork, Ireland.'}, {'ForeName': 'Jacobijn', 'Initials': 'J', 'LastName': 'Gussekloo', 'Affiliation': 'Leiden University Medical Center, Leiden, Netherlands.'}, {'ForeName': 'Rudi', 'Initials': 'R', 'LastName': 'Westendorp', 'Affiliation': 'Center for Healthy Aging, University of Copenhagen, Denmark.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Stott', 'Affiliation': 'Institute of Cardiovascular and Medical Sciences, University of Glasgow, Scotland, UK.'}, {'ForeName': 'Douglas C', 'Initials': 'DC', 'LastName': 'Bauer', 'Affiliation': 'University of San Francisco, California, United States.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Rodondi', 'Affiliation': 'Institute of Primary Health Care (BIHAM), University of Bern, Bern, Switzerland; Department of General Internal Medicine, Inselspital, Bern University Hospital, University of Bern, Switzerland. Electronic address: nicolas.rodondi@insel.ch.'}]",The American journal of medicine,['10.1016/j.amjmed.2020.01.018'] 251,30796153,Minimally Invasive Cordotomy for Refractory Cancer Pain: A Randomized Controlled Trial.,"BACKGROUND Up to 30% of patients with cancer continue to suffer from pain despite aggressive supportive care. The present study aimed to determine whether cordotomy can improve cancer pain refractory to interdisciplinary palliative care. MATERIALS AND METHODS In this randomized controlled trial, we recruited patients with refractory unilateral somatic pain, defined as a pain intensity (PI) ≥4, after more than three palliative care evaluations. Patients were randomized to percutaneous computed tomography-guided cordotomy or continued interdisciplinary palliative care. The primary outcome was 33% improvement in PI at 1 week after cordotomy or study enrollment as measured by the Edmonton Symptom Assessment Scale. RESULTS Sixteen patients were enrolled (nine female, median age 58 years). Six of seven patients (85.7%) randomized to cordotomy experienced >33% reduction in PI (median preprocedure PI = 7, range 6-10; 1 week after cordotomy median PI = 1, range 0-6; p = .022). Zero of nine patients randomized to palliative care achieved a 33% reduction in PI. Seven patients (77.8%) randomized to palliative care elected to undergo cordotomy after 1 week. All of these patients experienced >33% reduction in PI (median preprocedure PI = 8, range 4-10; 1 week after cordotomy median PI = 0, range 0-1; p = .022). No patients were withdrawn from the study because of adverse effects of the intervention. CONCLUSION These data support the use of cordotomy for pain refractory to optimal palliative care. The findings of this study justify a large-scale randomized controlled trial of percutaneous cordotomy. IMPLICATIONS FOR PRACTICE This prospective clinical trial was designed to determine the improvement in pain intensity in patients randomized to either undergo cordotomy or comprehensive palliative care for medically refractory cancer pain. This study shows that cordotomy is effective in reducing pain for medically refractory cancer pain, and these results can be used to design a large-scale comparative randomized controlled trial that could provide the evidence needed to include cordotomy as a treatment modality in the guidelines for cancer pain management.",2019,"Six of seven patients (85.7%) randomized to cordotomy experienced >33% reduction in PI (median preprocedure PI = 7, range 6-10; 1 week after cordotomy median PI = 1, range 0-6; p = .022).","['Refractory Cancer Pain', 'medically refractory cancer pain', 'Sixteen patients were enrolled (nine female, median age 58\u2009years', 'patients with cancer continue to suffer from pain despite aggressive supportive care', 'patients with refractory unilateral somatic pain, defined as a pain intensity (PI)\u2009≥4, after more than three palliative care evaluations']","['cordotomy', 'percutaneous cordotomy', 'undergo cordotomy or comprehensive palliative care', 'percutaneous computed tomography-guided cordotomy or continued interdisciplinary palliative care']","['PI', 'Edmonton Symptom Assessment Scale', 'pain intensity']","[{'cui': 'C0677936', 'cui_str': 'Refractory cancer'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C0234244', 'cui_str': 'Somatic Pain'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0700049', 'cui_str': 'Palliative care'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]","[{'cui': 'C0010009', 'cui_str': 'Cordotomy'}, {'cui': 'C0196243', 'cui_str': 'Spinal percutaneous cordotomy (procedure)'}, {'cui': 'C0700049', 'cui_str': 'Palliative care'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach - access (qualifier value)'}, {'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}]","[{'cui': 'C3494437', 'cui_str': 'Symptom Assessment'}, {'cui': 'C0222045'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}]",9.0,0.160036,"Six of seven patients (85.7%) randomized to cordotomy experienced >33% reduction in PI (median preprocedure PI = 7, range 6-10; 1 week after cordotomy median PI = 1, range 0-6; p = .022).","[{'ForeName': 'Ashwin', 'Initials': 'A', 'LastName': 'Viswanathan', 'Affiliation': 'Department of Neurosurgery, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA Aviswanathan@mdanderson.org.'}, {'ForeName': 'Aditya', 'Initials': 'A', 'LastName': 'Vedantam', 'Affiliation': 'Department of Neurosurgery, Baylor College of Medicine, Houston, Texas, USA.'}, {'ForeName': 'Kenneth R', 'Initials': 'KR', 'LastName': 'Hess', 'Affiliation': 'Department of Biostatistics, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Jewel', 'Initials': 'J', 'LastName': 'Ochoa', 'Affiliation': 'Department of Palliative Care and Rehabilitation Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Patrick M', 'Initials': 'PM', 'LastName': 'Dougherty', 'Affiliation': 'Department of Pain Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Akhila S', 'Initials': 'AS', 'LastName': 'Reddy', 'Affiliation': 'Department of Palliative Care and Rehabilitation Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Dhanalakshmi', 'Initials': 'D', 'LastName': 'Koyyalagunta', 'Affiliation': 'Department of Pain Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Suresh', 'Initials': 'S', 'LastName': 'Reddy', 'Affiliation': 'Department of Palliative Care and Rehabilitation Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Bruera', 'Affiliation': 'Department of Palliative Care and Rehabilitation Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.'}]",The oncologist,['10.1634/theoncologist.2018-0570'] 252,32282842,Yoga in school sports improves functioning of autonomic nervous system in young adults: A non-randomized controlled pilot study.,"BACKGROUND Yoga in school is a beneficial tool to promote the good health and well-being of students by changing the way they react to stress. The positive effects of yoga-taught in schools-on children, youth and young adults have been demonstrated in former studies using mostly subjective psychometric data. AIM The present trial aims to evaluate the potential effects of yoga on autonomic regulation in young adults by analyzing heart rate variability (HRV). METHODS This study is a non-randomized, explorative, two-arm-pilot study with an active control group. Fourteen healthy young adults took part in a 10-week yoga program (90 min once a week) in school and were compared to a control group of 11 students who participated in conventional school sports (90 min once a week over 10 weeks). 24-hour electrocardiograms (ECGs) were recorded at baseline and following the 10-week intervention. From 20-minute of nocturnal sleep phases, HRV parameters were calculated from linear (time and frequency domain) and nonlinear dynamics (such as symbolic dynamics and Poincaré plot analysis). Analyses of variance (ANOVA) followed by t-tests as post-hoc tests estimating both statistical significance and effect size were used to compare pre-post-intervention for the two groups. RESULTS The statistical analysis of the interaction effects did not reveal a significant group and time interaction for the individual nocturnal HRV indices. Almost all indices revealed medium and large effects regarding the time main effects. The changes in the HRV indices following the intervention were more dramatic for the yoga group than for the control group which is reflected in predominantly higher significances and stronger effect sizes in the yoga group. CONCLUSION In this explorative pilot trial, an increase of HRV (more parasympathetic dominance and overall higher HRV) after ten weeks of yoga in school in comparison to regular school sports was demonstrated, showing an improved self-regulation of the autonomic nervous system.",2020,"The changes in the HRV indices following the intervention were more dramatic for the yoga group than for the control group which is reflected in predominantly higher significances and stronger effect sizes in the yoga group. ","['schools-on children, youth and young adults', 'Fourteen healthy young adults', 'young adults', '11 students who participated in']","['conventional school sports', 'school sports', 'yoga program', 'yoga-taught']","['functioning of autonomic nervous system', 'HRV (more parasympathetic dominance and overall higher HRV', 'HRV indices', 'autonomic regulation', '24-hour electrocardiograms (ECGs']","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0038492', 'cui_str': 'Student'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0038039', 'cui_str': 'Sport'}, {'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0039401', 'cui_str': 'Education'}]","[{'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C1287621', 'cui_str': 'Eye dominance - finding'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0430461', 'cui_str': '24 Hour ECG'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}]",14.0,0.0330619,"The changes in the HRV indices following the intervention were more dramatic for the yoga group than for the control group which is reflected in predominantly higher significances and stronger effect sizes in the yoga group. ","[{'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Frank', 'Affiliation': 'Department of Pediatrics, Jena University Hospital, Jena, Germany.'}, {'ForeName': 'Georg', 'Initials': 'G', 'LastName': 'Seifert', 'Affiliation': 'Department of Pediatrics, Division of Oncology and Hematology, Charité - Universitätsmedizin, Berlin, Germany.'}, {'ForeName': 'Rico', 'Initials': 'R', 'LastName': 'Schroeder', 'Affiliation': 'Institute of Innovative Health Technologies IGHT, Ernst-Abbe-Hochschule Jena, Jena, Germany.'}, {'ForeName': 'Bernd', 'Initials': 'B', 'LastName': 'Gruhn', 'Affiliation': 'Department of Pediatrics, Jena University Hospital, Jena, Germany.'}, {'ForeName': 'Wiebke', 'Initials': 'W', 'LastName': 'Stritter', 'Affiliation': 'Department of Pediatrics, Division of Oncology and Hematology, Charité - Universitätsmedizin, Berlin, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Jeitler', 'Affiliation': 'Institute for Social Medicine, Epidemiology and Health Economics, Charité - Universitätsmedizin, Berlin, Germany.'}, {'ForeName': 'Nico', 'Initials': 'N', 'LastName': 'Steckhan', 'Affiliation': 'Institute for Social Medicine, Epidemiology and Health Economics, Charité - Universitätsmedizin, Berlin, Germany.'}, {'ForeName': 'Christian S', 'Initials': 'CS', 'LastName': 'Kessler', 'Affiliation': 'Institute for Social Medicine, Epidemiology and Health Economics, Charité - Universitätsmedizin, Berlin, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Michalsen', 'Affiliation': 'Institute for Social Medicine, Epidemiology and Health Economics, Charité - Universitätsmedizin, Berlin, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Voss', 'Affiliation': 'Institute of Innovative Health Technologies IGHT, Ernst-Abbe-Hochschule Jena, Jena, Germany.'}]",PloS one,['10.1371/journal.pone.0231299'] 253,32282852,"Early prevention of diabetes microvascular complications in people with hyperglycaemia in Europe. ePREDICE randomized trial. Study protocol, recruitment and selected baseline data.","OBJECTIVES To assess the effects of early management of hyperglycaemia with antidiabetic drugs plus lifestyle intervention compared with lifestyle alone, on microvascular function in adults with pre-diabetes. METHODS Trial design: International, multicenter, randomised, partially double-blind, placebo-controlled, clinical trial. PARTICIPANTS Males and females aged 45-74 years with IFG, IGT or IFG+IGT, recruited from primary care centres in Australia, Austria, Bulgaria, Greece, Kuwait, Poland, Serbia, Spain and Turkey. INTERVENTION Participants were randomized to placebo; metformin 1.700 mg/day; linagliptin 5 mg/day or fixed-dose combination of linagliptin/metformin. All patients were enrolled in a lifestyle intervention program (diet and physical activity). Drug intervention will last 2 years. Primary Outcome: composite end-point of diabetic retinopathy estimated by the Early Treatment Diabetic Retinopathy Study Score, urinary albumin to creatinine ratio, and skin conductance in feet estimated by the sudomotor index. Secondary outcomes in a subsample include insulin sensitivity, beta-cell function, biomarkers of inflammation and fatty liver disease, quality of life, cognitive function, depressive symptoms and endothelial function. RESULTS One thousand three hundred ninety one individuals with hyperglycaemia were assessed for eligibility, 424 excluded after screening, 967 allocated to placebo, metformin, linagliptin or to fixed-dose combination of metformin + linagliptin. A total of 809 people (91.1%) accepted and initiated the assigned treatment. Study sample after randomization was well balanced among the four groups. No statistical differences for the main risk factors analysed were observed between those accepting or rejecting treatment initiation. At baseline prevalence of diabetic retinopathy was 4.2%, severe neuropathy 5.3% and nephropathy 5.7%. CONCLUSIONS ePREDICE is the first -randomized clinical trial with the aim to assess effects of different interventions (lifestyle and pharmacological) on microvascular function in people with pre-diabetes. The trial will provide novel data on lifestyle modification combined with glucose lowering drugs for the prevention of early microvascular complications and diabetes. REGISTRATION - ClinicalTrials.Gov Identifier: NCT03222765 - EUDRACT Registry Number: 2013-000418-39.",2020,"At baseline prevalence of diabetic retinopathy was 4.2%, severe neuropathy 5.3% and nephropathy 5.7%. ","['people with pre-diabetes', 'One thousand three hundred ninety one individuals with hyperglycaemia were assessed for eligibility, 424 excluded after screening, 967 allocated to', 'Males and females aged 45-74 years with IFG, IGT or IFG+IGT, recruited from primary care centres in Australia, Austria, Bulgaria, Greece, Kuwait, Poland, Serbia, Spain and Turkey', '809 people (91.1%) accepted and initiated the assigned treatment', 'people with hyperglycaemia in Europe', 'adults with pre-diabetes']","['placebo; metformin', 'placebo', 'hyperglycaemia with antidiabetic drugs plus lifestyle intervention', 'interventions (lifestyle and pharmacological', 'glucose lowering drugs', 'linagliptin/metformin', 'linagliptin', 'lifestyle intervention program (diet and physical activity', 'placebo, metformin, linagliptin or to fixed-dose combination of metformin + linagliptin']","['microvascular function', 'subsample include insulin sensitivity, beta-cell function, biomarkers of inflammation and fatty liver disease, quality of life, cognitive function, depressive symptoms and endothelial function', 'diabetic retinopathy', 'composite end-point of diabetic retinopathy estimated by the Early Treatment Diabetic Retinopathy Study Score, urinary albumin to creatinine ratio, and skin conductance in feet estimated by the sudomotor index']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0004348', 'cui_str': 'Austria'}, {'cui': 'C0006368', 'cui_str': 'Bulgaria'}, {'cui': 'C0018226', 'cui_str': 'Greece'}, {'cui': 'C0022804', 'cui_str': 'Kuwait'}, {'cui': 'C0032356', 'cui_str': 'Poland'}, {'cui': 'C0036708', 'cui_str': 'Republic of Serbia'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C0041400', 'cui_str': 'Turkey - country'}, {'cui': 'C1272684', 'cui_str': 'Accepted'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0935929', 'cui_str': 'Antidiabetic agent'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0031330', 'cui_str': 'Pharmacology'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C3264599', 'cui_str': 'metformin and linagliptin'}, {'cui': 'C2746078', 'cui_str': 'Linagliptin'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]","[{'cui': 'C0443258', 'cui_str': 'Microvascular'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0030281', 'cui_str': 'Structure of beta Cell of islet'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0015695', 'cui_str': 'Fatty Liver'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0011884', 'cui_str': 'Retinopathy due to diabetes mellitus'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",1391.0,0.37646,"At baseline prevalence of diabetic retinopathy was 4.2%, severe neuropathy 5.3% and nephropathy 5.7%. ","[{'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Gabriel', 'Affiliation': 'Departamento de Salud Internacional, Escuela Nacional de Sanidad, Instituto de Salud Carlos III, Madrid, Spain.'}, {'ForeName': 'Nisa', 'Initials': 'N', 'LastName': 'Boukichou Abdelkader', 'Affiliation': 'EVIDEM CONSULTORES, Madrid, Spain.'}, {'ForeName': 'Tania', 'Initials': 'T', 'LastName': 'Acosta', 'Affiliation': 'EVIDEM CONSULTORES, Madrid, Spain.'}, {'ForeName': 'Aleksandra', 'Initials': 'A', 'LastName': 'Gilis-Januszewska', 'Affiliation': 'Uniwersytet Jagiellonski, Collegium Medicum, Krakow, Poland.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Gómez-Huelgas', 'Affiliation': 'Fundación FIMABIS. Servicio Andaluz de Salud (SAS), Malaga, Spain.'}, {'ForeName': 'Konstantinos', 'Initials': 'K', 'LastName': 'Makrilakis', 'Affiliation': 'National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Zdravko', 'Initials': 'Z', 'LastName': 'Kamenov', 'Affiliation': 'University Multi-Profile Hospital for Active Treatment Alexandrovska EAD, Sofia, Bulgaria.'}, {'ForeName': 'Bernhard', 'Initials': 'B', 'LastName': 'Paulweber', 'Affiliation': 'Gemeinnuetzige Salzburger Landeskliniken Betriebsgesellschaft, (SALK) Salzburg, Austria.'}, {'ForeName': 'Ilhan', 'Initials': 'I', 'LastName': 'Satman', 'Affiliation': 'Istanbul University, Istanbul, Turkey.'}, {'ForeName': 'Predrag', 'Initials': 'P', 'LastName': 'Djordjevic', 'Affiliation': 'General Hospital Medical System Beograd-MSB Belgrade Serbia, Beograd, Serbia.'}, {'ForeName': 'Abdullah', 'Initials': 'A', 'LastName': 'Alkandari', 'Affiliation': 'Dasman Diabetes Research Institute, Kuwait, Kuwait.'}, {'ForeName': 'Asimina', 'Initials': 'A', 'LastName': 'Mitrakou', 'Affiliation': 'Alexandra Hospital, University of Athens, Athens, Greece.'}, {'ForeName': 'Nebojsa', 'Initials': 'N', 'LastName': 'Lalic', 'Affiliation': 'Faculty of Medicine, University of Belgrade, Belgrade, Serbia.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Colagiuri', 'Affiliation': 'The University of Sydney, Boden Institute of Obesity, Nutrition, Exercise & Eating Disorders, Sydney, Australia.'}, {'ForeName': 'Jaana', 'Initials': 'J', 'LastName': 'Lindström', 'Affiliation': 'National Institute for Health and Welfare, Helsinki, Finland.'}, {'ForeName': 'Jesús', 'Initials': 'J', 'LastName': 'Egido', 'Affiliation': 'Renal, Vascular and Diabetes Research Laboratory, Spanish Biomedical Research Centre in Diabetes and Associated Metabolic Disorders (CIBERDEM), Instituto de Investigación Sanitaria Fundación Jiménez Díaz, Universidad Autónoma, Madrid, Spain.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Natali', 'Affiliation': 'Department of Internal Medicine, Universita di Pisa, Pisa, Italy.'}, {'ForeName': 'J Carlos', 'Initials': 'JC', 'LastName': 'Pastor', 'Affiliation': 'Instituto Universitario de Oftalmobiología Aplicada (IOBA), Universidad de Valladolid, Hospital Clínico Universitario, Valladolid, Spain.'}, {'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'Teuschl', 'Affiliation': 'Department for Clinical Neurosciences and Preventive Medicine, Danube University Krems, Krems, Austria.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Lind', 'Affiliation': 'Västra Götalands Läns Landsting, Gothenburg, Sweden.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Silva', 'Affiliation': 'EVIDEM CONSULTORES, Madrid, Spain.'}, {'ForeName': 'Ruy', 'Initials': 'R', 'LastName': 'López-Ridaura', 'Affiliation': 'Instituto Nacional de Salud Púbica, Cuernavaca, México.'}, {'ForeName': 'Jaakko', 'Initials': 'J', 'LastName': 'Tuomilehto', 'Affiliation': 'Departamento de Salud Internacional, Escuela Nacional de Sanidad, Instituto de Salud Carlos III, Madrid, Spain.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",PloS one,['10.1371/journal.pone.0231196'] 254,30845346,"Acute interaction between oral glucose (75 g as Lucozade) and inorganic nitrate: Decreased insulin clearance, but lack of blood pressure-lowering.","AIMS Dietary inorganic nitrate (NO 3 - ) lowers peripheral blood pressure (BP) in healthy volunteers, but lacks such effect in individuals with, or at risk of, type 2 diabetes mellitus (T2DM). Whilst this is commonly assumed to be a consequence of chronic hyperglycaemia/hyperinsulinaemia, we hypothesized that acute physiological elevations in plasma [glucose]/[insulin] blunt the haemodynamic responses to NO 3 - , a pertinent question for carbohydrate-rich Western diets. METHODS We conducted an acute, randomized, placebo-controlled, double-blind, crossover study on the haemodynamic and metabolic effects of potassium nitrate (8 or 24 mmol KNO 3 ) vs. potassium chloride (KCl; placebo) administered 1 hour prior to an oral glucose tolerance test in 33 healthy volunteers. RESULTS Compared to placebo, there were no significant differences in systolic or diastolic BP (P = 0.27 and P = 0.30 on ANOVA, respectively) with KNO 3 , nor in pulse wave velocity or central systolic BP (P = 0.99 and P = 0.54 on ANOVA, respectively). Whilst there were significant elevations from baseline for plasma [glucose] and [C-peptide], no differences between interventions were observed. A significant increase in plasma [insulin] was observed with KNO 3 vs. KCl (n = 33; P = 0.014 on ANOVA) with the effect driven by the high-dose cohort (24 mmol, n = 13; P < 0.001 on ANOVA; at T = 0.75 h mean difference 210.4 pmol/L (95% CI 28.5 to 392.3), P = 0.012). CONCLUSIONS In healthy adults, acute physiological elevations of plasma [glucose] and [insulin] result in a lack of BP-lowering with dietary nitrate. The increase in plasma [insulin] without a corresponding change in [C-peptide] or [glucose] suggests that high-dose NO 3 - decreases insulin clearance. A likely mechanism is via NO-dependent inhibition of insulin-degrading enzyme.",2019,"Whilst there were significant elevations from baseline for plasma [glucose] and [C-peptide], no differences between interventions were observed.","['healthy adults', '33 healthy volunteers', 'healthy volunteers', 'individuals with, or at risk of, type 2 diabetes mellitus (T2DM']","['potassium nitrate (8 or 24\xa0mmol KNO 3 ) vs. potassium chloride (KCl; placebo', 'oral glucose (75\xa0g as Lucozade) and inorganic nitrate', 'placebo', 'Dietary inorganic nitrate (NO 3 - ']","['blood pressure-lowering', 'pulse wave velocity or central systolic BP', 'peripheral blood pressure (BP', 'plasma [glucose] and [C-peptide', 'insulin clearance', 'plasma [insulin', 'systolic or diastolic BP']","[{'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0011860', 'cui_str': 'Diabetes Mellitus, Type 2'}]","[{'cui': 'C0071772', 'cui_str': 'potassium nitrate'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0032825', 'cui_str': 'Potassium Chloride'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0028125', 'cui_str': 'Nitrates'}]","[{'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C3494431', 'cui_str': 'Pulse Wave Velocity'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood (substance)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0006558', 'cui_str': 'Proinsulin C-Peptide'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}]",33.0,0.340369,"Whilst there were significant elevations from baseline for plasma [glucose] and [C-peptide], no differences between interventions were observed.","[{'ForeName': 'Christopher N', 'Initials': 'CN', 'LastName': 'Floyd', 'Affiliation': ""School of Cardiovascular Medicine and Sciences, Department of Clinical Pharmacology, King's College London British Heart Foundation Centre, London, UK.""}, {'ForeName': 'Satnam', 'Initials': 'S', 'LastName': 'Lidder', 'Affiliation': ""School of Cardiovascular Medicine and Sciences, Department of Clinical Pharmacology, King's College London British Heart Foundation Centre, London, UK.""}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Hunt', 'Affiliation': ""School of Cardiovascular Medicine and Sciences, Department of Clinical Pharmacology, King's College London British Heart Foundation Centre, London, UK.""}, {'ForeName': 'Sami A', 'Initials': 'SA', 'LastName': 'Omar', 'Affiliation': ""School of Cardiovascular Medicine and Sciences, Department of Clinical Pharmacology, King's College London British Heart Foundation Centre, London, UK.""}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'McNeill', 'Affiliation': ""School of Cardiovascular Medicine and Sciences, Department of Clinical Pharmacology, King's College London British Heart Foundation Centre, London, UK.""}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Webb', 'Affiliation': ""School of Cardiovascular Medicine and Sciences, Department of Clinical Pharmacology, King's College London British Heart Foundation Centre, London, UK.""}]",British journal of clinical pharmacology,['10.1111/bcp.13913'] 255,30729418,Implementation of a Systematic Tumor Screening Program for Lynch Syndrome in an Integrated Health Care Setting.,"A subset of colorectal cancer (CRC) cases are attributable to Lynch syndrome (LS), a hereditary form of CRC. Effective evaluation for LS can be done on CRC tumors to guide diagnostic testing. Increased diagnosis of LS allows for surveillance and risk reduction, which can mitigate CRC-related burden and prevent cancer-related deaths. We evaluated participation in LS screening among newly diagnosed adult CRC patients. Some cases were referred for genetics evaluation prior to study recruitment (selective screening). Those not referred directly were randomized to the intervention or control (usual care) arms. Control cases were observed for one year, then given information about LS screening. Patients who declined participation were followed through the medical record. Of 601 cases of CRC, 194 (32%) enrolled in our study and were offered LS screening, 43 (7%) were followed as a control group, 148 (25%) declined participation and 216 (36%) were ineligible [63 (10%) of which received prior selective screening]. Six and nine cases of LS were identified through the intervention and selective screening groups, respectively. Overall, a higher proportion of PMS2 variants were identified in the intervention (3/6, 50%) versus selective screening groups (2/9, 22%) (not statistically significant). Eighty-eight percent and 23% of intervention and control patients, respectively, received LS screening. No control patients were found to have LS. Systems-based approaches are needed to ensure we fully identify LS cases. The proportion of LS cases from this program was 4% of newly diagnosed cases of CRC, similar to other programs.",2019,No control patients were found to have LS.,"['Patients who declined participation were followed through the medical record', 'Of 601 cases of CRC, 194 (32%) enrolled in our study and were offered LS screening, 43 (7%) were followed as a control group, 148 (25%) declined participation and 216 (36%) were ineligible [63 (10%) of which received prior selective screening', 'newly diagnosed adult CRC patients']","['LS', 'Systematic Tumor Screening Program']",['proportion of PMS2 variants'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0025102', 'cui_str': 'Medical Records'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0170127', 'cui_str': 'Calcibiotic Root Canal Sealer'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0220922', 'cui_str': 'systematics'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0205419', 'cui_str': 'Variant (qualifier value)'}]",,0.0123846,No control patients were found to have LS.,"[{'ForeName': 'Elizabeth V', 'Initials': 'EV', 'LastName': 'Clarke', 'Affiliation': 'Center for Health Research, Kaiser Permanente Northwest, 3800 N. Interstate Avenue, Portland, OR, 97227, USA.'}, {'ForeName': 'Kristin R', 'Initials': 'KR', 'LastName': 'Muessig', 'Affiliation': 'Center for Health Research, Kaiser Permanente Northwest, 3800 N. Interstate Avenue, Portland, OR, 97227, USA.'}, {'ForeName': 'Jamilyn', 'Initials': 'J', 'LastName': 'Zepp', 'Affiliation': 'Center for Health Research, Kaiser Permanente Northwest, 3800 N. Interstate Avenue, Portland, OR, 97227, USA.'}, {'ForeName': 'Jessica E', 'Initials': 'JE', 'LastName': 'Hunter', 'Affiliation': 'Center for Health Research, Kaiser Permanente Northwest, 3800 N. Interstate Avenue, Portland, OR, 97227, USA.'}, {'ForeName': 'Sapna', 'Initials': 'S', 'LastName': 'Syngal', 'Affiliation': ""Dana-Farber Cancer Institute, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Louise S', 'Initials': 'LS', 'LastName': 'Acheson', 'Affiliation': 'Case Western Reserve University, University Hospitals Cleveland Medical Center, Cleveland, OH, USA.'}, {'ForeName': 'Georgia L', 'Initials': 'GL', 'LastName': 'Wiesner', 'Affiliation': 'Vanderbilt Hereditary Cancer Program, Vanderbilt-Ingram Cancer Center, Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Susan K', 'Initials': 'SK', 'LastName': 'Peterson', 'Affiliation': 'The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Kellene M', 'Initials': 'KM', 'LastName': 'Bergen', 'Affiliation': 'Center for Health Research, Kaiser Permanente Northwest, 3800 N. Interstate Avenue, Portland, OR, 97227, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Shuster', 'Affiliation': 'Center for Health Research, Kaiser Permanente Northwest, 3800 N. Interstate Avenue, Portland, OR, 97227, USA.'}, {'ForeName': 'James V', 'Initials': 'JV', 'LastName': 'Davis', 'Affiliation': 'Center for Health Research, Kaiser Permanente Northwest, 3800 N. Interstate Avenue, Portland, OR, 97227, USA.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Schneider', 'Affiliation': 'Center for Health Research, Kaiser Permanente Northwest, 3800 N. Interstate Avenue, Portland, OR, 97227, USA.'}, {'ForeName': 'Tia L', 'Initials': 'TL', 'LastName': 'Kauffman', 'Affiliation': 'Center for Health Research, Kaiser Permanente Northwest, 3800 N. Interstate Avenue, Portland, OR, 97227, USA.'}, {'ForeName': 'Marian J', 'Initials': 'MJ', 'LastName': 'Gilmore', 'Affiliation': 'Center for Health Research, Kaiser Permanente Northwest, 3800 N. Interstate Avenue, Portland, OR, 97227, USA.'}, {'ForeName': 'Jacob A', 'Initials': 'JA', 'LastName': 'Reiss', 'Affiliation': 'Center for Health Research, Kaiser Permanente Northwest, 3800 N. Interstate Avenue, Portland, OR, 97227, USA.'}, {'ForeName': 'Alan F', 'Initials': 'AF', 'LastName': 'Rope', 'Affiliation': 'Northwest Permanente, Kaiser Permanente Northwest, Portland, OR, USA.'}, {'ForeName': 'Jennifer E', 'Initials': 'JE', 'LastName': 'Cook', 'Affiliation': 'Center for Health Research, Kaiser Permanente Northwest, 3800 N. Interstate Avenue, Portland, OR, 97227, USA.'}, {'ForeName': 'Katrina A B', 'Initials': 'KAB', 'LastName': 'Goddard', 'Affiliation': 'Center for Health Research, Kaiser Permanente Northwest, 3800 N. Interstate Avenue, Portland, OR, 97227, USA. Katrina.AB.Goddard@kpchr.org.'}]",Familial cancer,['10.1007/s10689-019-00123-x'] 256,32302682,No Increased Cardiac Mortality or Morbidity of Radiation Therapy in Breast Cancer Patients After Breast-Conserving Surgery: 20-Year Follow-up of the Randomized SweBCGRT Trial.,"PURPOSE Radiation therapy (RT) after breast-conserving surgery reduces locoregional recurrences and improves survival but may cause late side effects. The main purpose of this paper was to investigate long-term side effects after whole breast RT in a randomized clinical trial initiated in 1991 and to report dose-volume data based on individual 3-dimensional treatment plans for organs at risk. METHODS AND MATERIALS The trial included 1187 patients with T1-2 N0 breast cancer randomized to postoperative tangential whole breast RT or no further treatment. The prescription dose to the clinical target volume was 48 to 54 Gy. We present 20-year follow-up on survival, cause of death, morbidity, and later malignancies. For a cohort of patients (n = 157) with accessible computed tomography-based 3-dimensional treatment plans in Dicom-RT format, dose-volume descriptors for organs at risk were derived. In addition, these were compared with dose-volume data for a cohort of patients treated with contemporary RT techniques. RESULTS The cumulative incidence of cardiac mortality was 12.4% in the control group and 13.0% in the RT group (P = .8). There was an increase in stroke mortality: 3.4% in the control group versus 6.7% in the RT group (P = .018). Incidences of contralateral breast cancer and lung cancer were similar between groups. The median D mean (range) heart dose for left-sided treatments was 3.0 Gy (1.1-8.1), and the corresponding value for patients treated in 2017 was 1.5 Gy (0.4-6.0). CONCLUSIONS In this trial, serious late side effects of whole breast RT were limited and less than previously reported in large meta-analyses. We observed no increase in cardiac mortality in irradiated patients. Doses to the heart were a median D mean of 3.0 Gy for left-sided RT. The observed increase in stroke mortality may partly be secondary to cardiac side effects, complications to anticoagulant treatment, or to chance, rather than a direct side effect of tangential whole breast irradiation.",2020,We observed no increased cardiac mortality in irradiated patients with doses to the heart were median,"['1187 T1-2 N0 breast cancer patients randomised to', 'breast cancer patients after breast conserving surgery', 'organs at risk (OR']","['radiotherapy', 'Radiotherapy (RT', 'postoperative tangential whole breast radiotherapy or no further treatment', 'whole breast radiotherapy']","['stroke mortality', 'cardiac mortality', 'median D mean (range) heart dose', 'cardiac mortality or morbidity', 'loco-regional recurrences and improves survival', 'Incidences of contra lateral breast cancer and lung cancer', 'cumulative incidence of cardiac mortality', 'survival, cause of death, morbidity and later malignancies']","[{'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0917927', 'cui_str': 'Breast conserving surgery'}, {'cui': 'C2936599', 'cui_str': 'Organs at Risk'}]","[{'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0457102', 'cui_str': 'Whole breast'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}]",1187.0,0.0509719,We observed no increased cardiac mortality in irradiated patients with doses to the heart were median,"[{'ForeName': 'Fredrika', 'Initials': 'F', 'LastName': 'Killander', 'Affiliation': 'Department of Clinical Sciences, Faculty of Medicine, Lund, Lund University, Sweden; Department of Haematology, Oncology and Radiation Physics, Skåne University Hospital, Lund, Sweden. Electronic address: fredrika.killander@med.lu.se.'}, {'ForeName': 'Elinore', 'Initials': 'E', 'LastName': 'Wieslander', 'Affiliation': 'Department of Haematology, Oncology and Radiation Physics, Skåne University Hospital, Lund, Sweden.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Karlsson', 'Affiliation': 'Department of Oncology, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Holmberg', 'Affiliation': 'Department of Oncology, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden; Region Västra Götaland, Regional Oncologic Centre West, Gothenburg, Sweden.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Lundstedt', 'Affiliation': 'Department of Oncology, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Holmberg', 'Affiliation': 'Department of Surgical Sciences, Uppsala University, Uppsala, Sweden; Translational Oncology & Urology Research (TOUR), School of Cancer and Pharmaceutical Sciences, Kingś College London, London, United Kingdom.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Werner', 'Affiliation': 'Department of Clinical Sciences, Faculty of Medicine, Lund, Lund University, Sweden.'}, {'ForeName': 'Sasha', 'Initials': 'S', 'LastName': 'Koul', 'Affiliation': 'Department of Cardiology, Lund University, Skåne University Hospital, Lund, Sweden.'}, {'ForeName': 'Mahnaz', 'Initials': 'M', 'LastName': 'Haghanegi', 'Affiliation': 'Department of Haematology, Oncology and Radiation Physics, Skåne University Hospital, Lund, Sweden.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Kjellen', 'Affiliation': 'Department of Clinical Sciences, Faculty of Medicine, Lund, Lund University, Sweden; Department of Haematology, Oncology and Radiation Physics, Skåne University Hospital, Lund, Sweden.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Nilsson', 'Affiliation': 'Department of Haematology, Oncology and Radiation Physics, Skåne University Hospital, Lund, Sweden; Department of Clinical Sciences, Faculty of Medicine, Lund University, Lund, Sweden.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Malmström', 'Affiliation': 'Department of Clinical Sciences, Faculty of Medicine, Lund, Lund University, Sweden; Department of Haematology, Oncology and Radiation Physics, Skåne University Hospital, Lund, Sweden.'}]","International journal of radiation oncology, biology, physics",['10.1016/j.ijrobp.2020.04.003'] 257,31013363,MRI Assessment of Treatment Response in HIV-associated NAFLD: A Randomized Trial of a Stearoyl-Coenzyme-A-Desaturase-1 Inhibitor (ARRIVE Trial).,"Aramchol, an oral stearoyl-coenzyme-A-desaturase-1 inhibitor, has been shown to reduce hepatic fat content in patients with primary nonalcoholic fatty liver disease (NAFLD); however, its effect in patients with human immunodeficiency virus (HIV)-associated NAFLD is unknown. The aramchol for HIV-associated NAFLD and lipodystrophy (ARRIVE) trial was a double-blind, randomized, investigator-initiated, placebo-controlled trial to test the efficacy of 12 weeks of treatment with aramchol versus placebo in HIV-associated NAFLD. Fifty patients with HIV-associated NAFLD, defined by magnetic resonance imaging (MRI)-proton density fat fraction (PDFF) ≥5%, were randomized to receive either aramchol 600 mg daily (n = 25) or placebo (n = 25) for 12 weeks. The primary endpoint was a change in hepatic fat as measured by MRI-PDFF in colocalized regions of interest. Secondary endpoints included changes in liver stiffness using magnetic resonance elastography (MRE) and vibration-controlled transient elastography (VCTE), and exploratory endpoints included changes in total-body fat and muscle depots on dual-energy X-ray absorptiometry (DXA), whole-body MRI, and cardiac MRI. The mean (± standard deviation) of age and body mass index were 48.2 ± 10.3 years and 30.7 ± 4.6 kg/m 2 , respectively. There was no difference in the reduction in mean MRI-PDFF between the aramchol group at -1.3% (baseline MRI-PDFF 15.6% versus end-of-treatment MRI-PDFF 14.4%, P = 0.24) and the placebo group at -1.4% (baseline MRI-PDFF 13.3% versus end-of-treatment MRI-PDFF 11.9%, P = 0.26). There was no difference in the relative decline in mean MRI-PDFF between the aramchol and placebo groups (6.8% versus 1.1%, P = 0.68). There were no differences in MRE-derived and VCTE-derived liver stiffness and whole-body (fat and muscle) composition analysis by MRI or DXA. Compared to baseline, end-of-treatment aminotransferases were lower in the aramchol group but not in the placebo arm. There were no significant adverse events. Conclusion: Aramchol, over a 12-week period, did not reduce hepatic fat or change body fat and muscle composition by using MRI-based assessment in patients with HIV-associated NAFLD (clinicaltrials.gov ID:NCT02684591).",2019,"Secondary endpoints included changes in liver stiffness using magnetic resonance elastography (MRE) and vibration-controlled transient elastography (VCTE), and exploratory endpoints included changes in total-body fat and muscle depots on dual-energy X-ray absorptiometry (DXA), whole-body MRI, and cardiac MRI.","['Fifty patients with HIV-associated NAFLD, defined by magnetic resonance imaging (MRI)-proton density fat fraction (PDFF) ≥5', 'patients with primary nonalcoholic fatty liver disease (NAFLD', 'HIV-associated NAFLD']","['placebo', 'Aramchol, an oral stearoyl-coenzyme-A-desaturase-1 inhibitor', 'aramchol 600 mg daily (n\xa0=\xa025) or placebo', 'aramchol versus placebo', 'Stearoyl-Coenzyme-A-Desaturase-1 Inhibitor']","['hepatic fat or change body fat and muscle composition', 'MRE-derived and VCTE-derived liver stiffness and whole-body (fat and muscle) composition analysis by MRI or DXA', 'change in hepatic fat', 'changes in liver stiffness using magnetic resonance elastography (MRE) and vibration-controlled transient elastography (VCTE), and exploratory endpoints included changes in total-body fat and muscle depots on dual-energy X-ray absorptiometry (DXA), whole-body MRI, and cardiac MRI', 'mean (± standard deviation) of age and body mass index', 'mean MRI-PDFF']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0400966', 'cui_str': 'NAFLD'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C1552358', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0033727', 'cui_str': 'Hydrogen Ions'}, {'cui': 'C0178587', 'cui_str': 'Mass to volume ratio'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C1264633', 'cui_str': 'Fractions of (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1122583', 'cui_str': '(3beta,5beta,7alpha,12alpha)-7,12-dihydroxy-3-(icosanoylamino)cholan-24-oic acid'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0075202', 'cui_str': 'stearyl-CoA'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}]","[{'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0344335', 'cui_str': 'Body Fat'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C0427008', 'cui_str': 'Stiffness (finding)'}, {'cui': 'C0444584', 'cui_str': 'Whole body (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C1518156', 'cui_str': 'Magnetic Resonance Elastography'}, {'cui': 'C3854624', 'cui_str': 'Vibration controlled transient elastography'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0424677', 'cui_str': 'Total body fat (observable entity)'}, {'cui': 'C1510486', 'cui_str': 'Dual X-Ray Absorptiometry'}, {'cui': 'C1142375', 'cui_str': 'Magnetic resonance imaging of whole body'}, {'cui': 'C0412692', 'cui_str': 'Magnetic resonance imaging of heart'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]",50.0,0.376089,"Secondary endpoints included changes in liver stiffness using magnetic resonance elastography (MRE) and vibration-controlled transient elastography (VCTE), and exploratory endpoints included changes in total-body fat and muscle depots on dual-energy X-ray absorptiometry (DXA), whole-body MRI, and cardiac MRI.","[{'ForeName': 'Veeral H', 'Initials': 'VH', 'LastName': 'Ajmera', 'Affiliation': 'NAFLD Research Center, University of California San Diego Health, La Jolla, CA.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Cachay', 'Affiliation': 'Division of Infectious Diseases, Owen Clinic, University of California San Diego, San Diego, CA.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Ramers', 'Affiliation': 'Family Health Center, San Diego, CA.'}, {'ForeName': 'Irine', 'Initials': 'I', 'LastName': 'Vodkin', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, University of California San Diego Health, La Jolla, CA.'}, {'ForeName': 'Shirin', 'Initials': 'S', 'LastName': 'Bassirian', 'Affiliation': 'NAFLD Research Center, University of California San Diego Health, La Jolla, CA.'}, {'ForeName': 'Seema', 'Initials': 'S', 'LastName': 'Singh', 'Affiliation': 'NAFLD Research Center, University of California San Diego Health, La Jolla, CA.'}, {'ForeName': 'Neeraj', 'Initials': 'N', 'LastName': 'Mangla', 'Affiliation': 'NAFLD Research Center, University of California San Diego Health, La Jolla, CA.'}, {'ForeName': 'Richele', 'Initials': 'R', 'LastName': 'Bettencourt', 'Affiliation': 'NAFLD Research Center, University of California San Diego Health, La Jolla, CA.'}, {'ForeName': 'Jeannette L', 'Initials': 'JL', 'LastName': 'Aldous', 'Affiliation': 'San Ysidro Health, San Diego, CA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Park', 'Affiliation': 'San Ysidro Health, San Diego, CA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Lee', 'Affiliation': 'Division of Infectious Diseases, Owen Clinic, University of California San Diego, San Diego, CA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Blanchard', 'Affiliation': 'Division of Infectious Diseases, Owen Clinic, University of California San Diego, San Diego, CA.'}, {'ForeName': 'Adrija', 'Initials': 'A', 'LastName': 'Mamidipalli', 'Affiliation': 'Liver Imaging Group, University of California San Diego, La Jolla, CA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Boehringer', 'Affiliation': 'Liver Imaging Group, University of California San Diego, La Jolla, CA.'}, {'ForeName': 'Saima', 'Initials': 'S', 'LastName': 'Aslam', 'Affiliation': 'Division of Infectious Diseases and Global Public Health, University of California San Diego, San Diego, CA.'}, {'ForeName': 'Olof Dahlqvist', 'Initials': 'OD', 'LastName': 'Leinhard', 'Affiliation': 'AMRA Medical AB, Linköping, Sweden.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Richards', 'Affiliation': 'NAFLD Research Center, University of California San Diego Health, La Jolla, CA.'}, {'ForeName': 'Claude', 'Initials': 'C', 'LastName': 'Sirlin', 'Affiliation': 'Liver Imaging Group, University of California San Diego, La Jolla, CA.'}, {'ForeName': 'Rohit', 'Initials': 'R', 'LastName': 'Loomba', 'Affiliation': 'NAFLD Research Center, University of California San Diego Health, La Jolla, CA.'}]","Hepatology (Baltimore, Md.)",['10.1002/hep.30674'] 258,32304832,"Efficacy and Safety of Ragweed SLIT-Tablet in Children with Allergic Rhinoconjunctivitis in a Randomized, Placebo-Controlled Trial.","BACKGROUND Ragweed sublingual immunotherapy (SLIT) tablet reduces symptoms and symptom-relieving medication use in adults with allergic rhinitis with or without conjunctivitis (AR/C) but has not been evaluated in children. OBJECTIVE This international, multicenter, double-blind, placebo-controlled trial evaluated the efficacy and safety of ragweed SLIT-tablet in children with AR/C. METHODS Children (N = 1025; 77.7% polysensitized) aged 5 to 17 years with ragweed pollen-induced AR/C with or without asthma (FEV 1 ≥80% predicted) were randomized 1:1 to daily ragweed SLIT-tablet (12 Amb a 1-Unit) or placebo for up to 28 weeks (NCT02478398). The primary end point was the average total combined score (TCS; sum of rhinoconjunctivitis daily symptom score [DSS] and daily medication score [DMS]) during peak ragweed pollen season (RPS). Key secondary end points were TCS during the entire RPS, and DSS and DMS during the peak RPS. RESULTS Relative TCS (95% CI) improvements with ragweed SLIT-tablet versus placebo were -38.3% (-46.0% to -29.7%; least square [LS] mean difference, -2.73; P < .001) during peak RPS and -32.4% (-40.7% to -23.3%; LS mean difference, -1.86; P < .001) during the entire RPS. DSS and DMS during peak RPS improved with SLIT-tablet versus placebo by -35.4% (-43.2% to -26.1%; LS mean difference, -1.40; P < .001) and -47.7% (-59.8% to -32.5%; LS mean difference, -1.84; P < .001), respectively. Asthma DSS, short-acting β-agonist use, and nocturnal awakenings during peak RPS improved with SLIT-tablet versus placebo by -30.7%, -68.1%, and -75.1%, respectively (all nominal P ≤ .02). No events of anaphylaxis, airway compromise, or severe treatment-related systemic allergic reactions were reported. CONCLUSIONS Ragweed SLIT-tablet significantly improved symptoms and decreased symptom-relieving medication use in children with ragweed pollen-induced AR/C and was well tolerated.",2020,Ragweed SLIT-tablet significantly improved symptoms and decreased symptom-relieving medication use in children with ragweed pollen-induced AR/C and was well tolerated.,"['Children with Allergic Rhinoconjunctivitis', 'children with AR/C.\nMETHODS\n\n\nChildren (N=1025; 77.7% polysensitized) aged 5-17 years with ragweed pollen-induced AR/C with or without asthma (FEV 1 ≥80% predicted', 'adults with allergic rhinitis with or without conjunctivitis (AR/C']","['Ragweed SLIT-Tablet', 'ragweed SLIT-tablet', 'placebo', 'SLIT-tablet versus placebo', 'Ragweed SLIT-tablet', 'Placebo', 'daily ragweed SLIT-tablet (12 Amb a 1-Unit ) or placebo']","['Efficacy and Safety', 'average total combined score (TCS; sum of rhinoconjunctivitis daily symptom score [DSS] and daily medication score [DMS]) during peak ragweed pollen season (RPS', 'DSS and DMS during peak RPS', 'anaphylaxis, airway compromise, or severe treatment-related systemic allergic reactions', 'tolerated', 'TCS during the entire RPS, and DSS and DMS during peak RPS', 'Asthma DSS, short-acting beta-agonist use, and nocturnal awakenings during peak RPS', 'efficacy and safety']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0861154', 'cui_str': 'Allergic rhinoconjunctivitis'}, {'cui': 'C0009763', 'cui_str': 'Conjunctivitis'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0440357', 'cui_str': 'Ragweed pollen'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C2607914', 'cui_str': 'Allergic rhinitis'}]","[{'cui': 'C0331432', 'cui_str': 'Ambrosia'}, {'cui': 'C0184904', 'cui_str': 'Slitting'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0439148', 'cui_str': 'Unit'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0242387', 'cui_str': 'Treacher Collins syndrome'}, {'cui': 'C0861155', 'cui_str': 'Rhinoconjunctivitis'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0440357', 'cui_str': 'Ragweed pollen'}, {'cui': 'C0036497', 'cui_str': 'Seasons'}, {'cui': 'C0011195', 'cui_str': 'Déjérine-Sottas disease'}, {'cui': 'C0012384', 'cui_str': 'Succimer'}, {'cui': 'C0002792', 'cui_str': 'Anaphylaxis'}, {'cui': 'C4055482', 'cui_str': 'Airway compromise'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1736167', 'cui_str': 'Systemic allergic reaction'}, {'cui': 'C0439751', 'cui_str': 'Entire'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0330390', 'cui_str': 'Beta'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0860510', 'cui_str': 'Nocturnal awakening'}]",,0.42318,Ragweed SLIT-tablet significantly improved symptoms and decreased symptom-relieving medication use in children with ragweed pollen-induced AR/C and was well tolerated.,"[{'ForeName': 'Hendrik', 'Initials': 'H', 'LastName': 'Nolte', 'Affiliation': 'ALK, Bedminster, NJ. Electronic address: Hendrik.nolte@alk.net.'}, {'ForeName': 'David I', 'Initials': 'DI', 'LastName': 'Bernstein', 'Affiliation': 'Division of Immunology, Allergy and Rheumatology, University of Cincinnati College of Medicine, Cincinnati, Ohio.'}, {'ForeName': 'Harold S', 'Initials': 'HS', 'LastName': 'Nelson', 'Affiliation': 'Department of Medicine, Allergy/Immunology Service, National Jewish Health, Denver, Colo.'}, {'ForeName': 'Anne K', 'Initials': 'AK', 'LastName': 'Ellis', 'Affiliation': ""Division of Allergy & Immunology, Department of Medicine, Queen's University, Kingston, ON, Canada.""}, {'ForeName': 'Jörg', 'Initials': 'J', 'LastName': 'Kleine-Tebbe', 'Affiliation': 'Allergy & Asthma Center Westend, Berlin, Germany.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Lu', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ.'}]",The journal of allergy and clinical immunology. In practice,['10.1016/j.jaip.2020.03.041'] 259,32301166,A multi-center international study of acupuncture for lateral elbow pain - Results of a randomized controlled trial.,"BACKGROUND Lateral elbow pain (LEP) due to tendinosis is one of the most common musculoskeletal pains of the upper limbs, yet there is no satisfactory treatment. This study was an international, prospective, multi-centre, randomized, controlled, clinical trial to evaluate the efficacy of acupuncture compared to sham laser in the treatment of LEP. METHODS The study used a parallel and stratified design (1:1 allocation using a computer-generated sequence) and was participant-, outcome assessor- and statistician-blinded. Subjects from 18 to 80 years with unilateral chronic LEP (minimum three months) were recruited at four centres in Australia, China, Hong Kong and Italy. The treatment group received manual acupuncture at acupoints LI 10 and LI 11 on the affected side whereas the control group received sham laser acupuncture at the same acupoints. The primary endpoint was disabilities of the arm, shoulder, and hand (DASH) questionnaire score at the three-week post-treatment follow-up visit. Three VAS scales (pain at rest, pain on motion and pain during exertion) were secondary outcomes measures. Ninety-six subjects were allocated to either the treatment group (n = 47) or control group (n = 49) and were all included in the analysis. RESULTS At the follow-up visit, we found significant differences in DASH score between the two groups (p = .015). The median change to baseline for the treatment group was -11.7 (interval: -50.83 to 23.33), and for the control group -7.50 (interval: -36.67 to 29.10). The estimated effect size was 0.47, indicating a medium effect. Significant differences were also found for secondary outcome measures for VAS of pain. There were no severe adverse events. Our findings suggest that acupuncture has a moderate efficacy in the treatment of LEP. CONCLUSIONS Acupuncture was shown to be efficacious in improving the function of the arm associated with lateral elbow tendinosis. Both the DASH score and the pain VAS on two occasions (at rest and during motion) showed a significant change over time indicating acupuncture as a potential treatment for LEP due to tendinosis.",2020,"At the follow-up visit, we found significant differences in DASH score between the two groups (P = 0.015).","['lateral elbow pain ', 'Subjects from 18 to 80 years with unilateral chronic LEP (minimum three months) were recruited at four centers in Australia, China, Hong Kong and Italy', 'Ninety-six subjects']","['acupuncture', 'Acupuncture', 'manual acupuncture at acupoints LI 10 and LI 11 on the affected side whereas the control group received sham-laser acupuncture']","['VAS scales (pain at rest, pain on motion and pain during exertion', 'severe adverse events', 'disabilities of the arm, shoulder, and hand (DASH) questionnaire score', 'DASH score and the VAS pain', 'VAS pain', 'DASH score']","[{'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0239266', 'cui_str': 'Pain in elbow'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C4082119', 'cui_str': 'Three months'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0019907', 'cui_str': 'Hong Kong'}, {'cui': 'C0022277', 'cui_str': 'Italy'}, {'cui': 'C4319625', 'cui_str': '96'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0001302', 'cui_str': 'Acupuncture point'}, {'cui': 'C0392760', 'cui_str': 'Affecting'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0394654', 'cui_str': 'Laser acupuncture'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0234253', 'cui_str': 'Rest pain'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0026597', 'cui_str': 'Motion'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C1519275', 'cui_str': 'Common terminology criteria for adverse events grade 3'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",96.0,0.137827,"At the follow-up visit, we found significant differences in DASH score between the two groups (P = 0.015).","[{'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Gadau', 'Affiliation': 'School of Chinese Medicine, Hong Kong Baptist University, Kowloon Tong, Hong Kong.'}, {'ForeName': 'Shi Ping', 'Initials': 'SP', 'LastName': 'Zhang', 'Affiliation': 'School of Chinese Medicine, Hong Kong Baptist University, Kowloon Tong, Hong Kong.'}, {'ForeName': 'Fu Chun', 'Initials': 'FC', 'LastName': 'Wang', 'Affiliation': 'Changchun University of Traditional Chinese Medicine, Changchun, China.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Liguori', 'Affiliation': 'Istituto Paracelso, Rome, Italy.'}, {'ForeName': 'Wei Hong', 'Initials': 'WH', 'LastName': 'Li', 'Affiliation': 'School of Life Sciences, University of Technology Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Wei Hong', 'Initials': 'WH', 'LastName': 'Liu', 'Affiliation': 'World Federation of Acupuncture and Moxibustion Societies, Beijing, China.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Bangrazi', 'Affiliation': 'Istituto Paracelso, Rome, Italy.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Berle', 'Affiliation': 'World Federation of Acupuncture and Moxibustion Societies, Beijing, China.'}, {'ForeName': 'Shohreh', 'Initials': 'S', 'LastName': 'Razavy', 'Affiliation': 'School of Life Sciences, University of Technology Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Zhao Xiang', 'Initials': 'ZX', 'LastName': 'Bian', 'Affiliation': 'School of Chinese Medicine, Hong Kong Baptist University, Kowloon Tong, Hong Kong.'}, {'ForeName': 'Petti', 'Initials': 'P', 'LastName': 'Filomena', 'Affiliation': 'Istituto Paracelso, Rome, Italy.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Hao', 'Affiliation': 'World Federation of Acupuncture and Moxibustion Societies, Beijing, China.'}, {'ForeName': 'Hai Lin', 'Initials': 'HL', 'LastName': 'Jiang', 'Affiliation': 'Changchun University of Traditional Chinese Medicine, Changchun, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Lei', 'Affiliation': 'World Federation of Acupuncture and Moxibustion Societies, Beijing, China.'}, {'ForeName': 'Tie', 'Initials': 'T', 'LastName': 'Li', 'Affiliation': 'Changchun University of Traditional Chinese Medicine, Changchun, China.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Zaslawski', 'Affiliation': 'School of Life Sciences, University of Technology Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Aldo', 'Initials': 'A', 'LastName': 'Liguori', 'Affiliation': 'Istituto Paracelso, Rome, Italy.'}, {'ForeName': 'Yan Song', 'Initials': 'YS', 'LastName': 'Liu', 'Affiliation': 'Changchun University of Traditional Chinese Medicine, Changchun, China.'}, {'ForeName': 'Ai Ping', 'Initials': 'AP', 'LastName': 'Lu', 'Affiliation': 'School of Chinese Medicine, Hong Kong Baptist University, Kowloon Tong, Hong Kong.'}, {'ForeName': 'Yuan Sheng', 'Initials': 'YS', 'LastName': 'Tan', 'Affiliation': 'World Federation of Acupuncture and Moxibustion Societies, Beijing, China.'}, {'ForeName': 'Wendy Wansze', 'Initials': 'WW', 'LastName': 'Yim', 'Affiliation': 'School of Chinese Medicine, Hong Kong Baptist University, Kowloon Tong, Hong Kong.'}, {'ForeName': 'Chuan Long', 'Initials': 'CL', 'LastName': 'Xie', 'Affiliation': 'College of Economics, Jinan University, Guangzhou, China.'}]","European journal of pain (London, England)",['10.1002/ejp.1574'] 260,32299852,Short-term and long-term effect of a high-intensity pulmonary rehabilitation programme in obese patients with asthma: a randomised controlled trial.,"OBJECTIVE To determine the short-term and long-term effects of a high intensity pulmonary rehabilitation programme on asthma control, body composition, lung function and exercise capacity in obese asthma patients. METHODS Patients with obesity (body mass index (BMI)≥30 kg·m -2 ) and suboptimal controlled asthma (Asthma Control Questionnaire (ACQ)≥0.75) were randomly assigned to a 3-month pulmonary rehabilitation programme (PR only), pulmonary rehabilitation programme with the use of an internet based self-management support programme (PR+SMS) or usual care. The pulmonary rehabilitation programme included high-intensity interval training, nutritional intervention and psychological group sessions. Patients in the usual care group were advised to lose weight and to exercise. The primary outcome was the difference of change of ACQ between PR only and PR+SMS after 3 months. Total follow-up was 12 months. RESULTS 34 patients were included in the study (14 PR only, nine PR+SMS, 11 control). Compared with patients in usual care, patients in the PR only group had a significant reduction in BMI and significant improvements in asthma control, exercise capacity and aerobic capacity after 3 months. These improvements persisted during 12 months of follow-up. No difference in ACQ between PR+SMS and PR only groups was observed. However, users of the SMS programme had a significantly lower BMI after 12 months compared with subjects in the PR only group. CONCLUSION A high-intensity pulmonary rehabilitation programme provides sustained improvements in asthma control, body composition and exercise capacity in obese asthmatics that are not optimally controlled and, therefore, should be considered in the treatment of these patients.",2020,"A high intensity pulmonary rehabilitation program provides sustained improvements in asthma control, body composition and exercise capacity in obese asthmatics that are not optimally controlled and, therefore, should be considered in the treatment of these patients.","['obese asthmatics', 'obese patients with asthma', 'obese asthma patients', 'Thirty-four patients were included in the study (14 PRonly, 9 PR+SMS, 11 control', 'Patients with obesity (BMI≥30\u2005kg·m -2 ) and suboptimal controlled asthma (Asthma Control Questionnaire (ACQ)≥0.75']","['high intensity pulmonary rehabilitation program', 'pulmonary rehabilitation program (PR only), pulmonary rehabilitation program with the use of an internet based self-management support program (PR+SMS) or usual care', 'high intensity pulmonary rehabilitation (PR) program']","['asthma control, body composition and exercise capacity', 'ACQ', 'BMI', 'asthma control, exercise capacity and aerobic capacity', 'asthma control, body composition, lung function and exercise capacity', 'change of ACQ between PRonly and PR+SMS']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C2919686', 'cui_str': 'Asthma control questionnaire'}]","[{'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0199529', 'cui_str': 'Pulmonary rehabilitation'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}]","[{'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C2919686', 'cui_str': 'Asthma control questionnaire'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}]",34.0,0.0270779,"A high intensity pulmonary rehabilitation program provides sustained improvements in asthma control, body composition and exercise capacity in obese asthmatics that are not optimally controlled and, therefore, should be considered in the treatment of these patients.","[{'ForeName': 'Yasemin', 'Initials': 'Y', 'LastName': 'Türk', 'Affiliation': 'Dept of Pulmonology Franciscus Gasthuis & Vlietland Rotterdam The Netherlands y.turk@franciscus.nl.'}, {'ForeName': 'Willy', 'Initials': 'W', 'LastName': 'Theel', 'Affiliation': 'Dept of Physiotherapy, Franciscus Gasthuis & Vlietland, Rotterdam, The Netherlands.'}, {'ForeName': 'Astrid', 'Initials': 'A', 'LastName': 'van Huisstede', 'Affiliation': 'Dept of Pulmonology Franciscus Gasthuis & Vlietland Rotterdam The Netherlands.'}, {'ForeName': 'Gert-Jan M', 'Initials': 'GM', 'LastName': 'van de Geijn', 'Affiliation': 'Dept of Clinical Chemistry, Franciscus Gasthuis & Vlietland, Rotterdam, The Netherlands.'}, {'ForeName': 'Erwin', 'Initials': 'E', 'LastName': 'Birnie', 'Affiliation': 'Dept of Genetics, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Pieter S', 'Initials': 'PS', 'LastName': 'Hiemstra', 'Affiliation': 'Dept of Pulmonology, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Jacob K', 'Initials': 'JK', 'LastName': 'Sont', 'Affiliation': 'Dept of Biomedical Data Sciences, Section Medical Decision Making, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Taube', 'Affiliation': 'Dept of Pulmonology, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Gert-Jan', 'Initials': 'GJ', 'LastName': 'Braunstahl', 'Affiliation': 'Dept of Pulmonology Franciscus Gasthuis & Vlietland Rotterdam The Netherlands.'}]",The European respiratory journal,['10.1183/13993003.01820-2019'] 261,31825647,Lung Screen Uptake Trial (LSUT): Randomized Controlled Clinical Trial Testing Targeted Invitation Materials.,"Rationale: Low uptake of low-dose computed tomography (LDCT) lung cancer screening, particularly by current smokers of a low socioeconomic position, compromises effectiveness and equity. Objectives: To compare the effect of a targeted, low-burden, and stepped invitation strategy versus control on uptake of hospital-based Lung Health Check appointments offering LDCT screening. Methods: In a two-arm, blinded, between-subjects, randomized controlled trial, 2,012 participants were selected from 16 primary care practices using these criteria: 1 ) aged 60 to 75 years, 2 ) recorded as a current smoker within the last 7 years, and 3 ) no prespecified exclusion criteria contraindicating LDCT screening. Both groups received a stepped sequence of preinvitation, invitation, and reminder letters from their primary care practitioner offering prescheduled appointments. The key manipulation was the accompanying leaflet. The intervention group's leaflet targeted psychological barriers and provided low-burden information, mimicking the concept of the U.K. Ministry of Transport's annual vehicle test (""M.O.T. For Your Lungs""). Measurements and Main Results: Uptake was 52.6%, with no difference between intervention (52.3%) and control (52.9%) groups in unadjusted (odds ratio [OR], 0.98; 95% confidence interval [CI], 0.82-1.16) or adjusted (OR, 0.98; 95% CI, 0.82-1.17) analyses. Current smokers were less likely to attend (adjusted OR, 0.70; 95% CI, 0.56-0.86) than former smokers. Socioeconomic deprivation was significantly associated with lower uptake for the control group only ( P  < 0.01). Conclusions: The intervention did not improve uptake. Regardless of trial arm, uptake was considerably higher than previous clinical and real-world studies, particularly given that the samples were predominantly lower socioeconomic position smokers. Strategies common to both groups, including a Lung Health Check approach, could represent a minimum standard.Clinical trial registered with www.clinicaltrials.gov (NCT02558101) and registered prospectively with the International Standard Registered Clinical/Social Study (N21774741).",2020,"Current smokers were less likely to attend (adjusted OR, 0.70; 95% CI, 0.56-0.86) than former smokers.","['Lung Screen Uptake Trial (LSUT', '2,012 participants were selected from 16 primary care practices using these criteria: 1 ) aged 60 to 75 years, 2 ) recorded as a current smoker within the last 7 years, and 3 ']","['low-dose computed tomography (LDCT) lung cancer screening', 'stepped sequence of preinvitation, invitation, and reminder letters from their primary care practitioner offering prescheduled appointments', 'intervention group\'s leaflet targeted psychological barriers and provided low-burden information, mimicking the concept of the U.K. Ministry of Transport\'s annual vehicle test (""M.O.T. For Your Lungs']","['Socioeconomic deprivation', 'uptake']","[{'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}]","[{'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0281477', 'cui_str': 'Screening for malignant neoplasm of lung'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0004793', 'cui_str': 'Base sequence'}, {'cui': 'C0282413', 'cui_str': 'Letters as Topic'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0003629', 'cui_str': 'Appointments'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0005528', 'cui_str': 'Biological transport'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0042444', 'cui_str': 'Drug vehicle'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}]","[{'cui': 'C0037464', 'cui_str': 'Factors, Socioeconomic'}]",2012.0,0.164682,"Current smokers were less likely to attend (adjusted OR, 0.70; 95% CI, 0.56-0.86) than former smokers.","[{'ForeName': 'Samantha L', 'Initials': 'SL', 'LastName': 'Quaife', 'Affiliation': 'Research Department of Behavioural Science and Health and.'}, {'ForeName': 'Mamta', 'Initials': 'M', 'LastName': 'Ruparel', 'Affiliation': 'Lungs for Living Research Centre, UCL Respiratory, Division of Medicine, University College London, London, United Kingdom.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Dickson', 'Affiliation': 'Lungs for Living Research Centre, UCL Respiratory, Division of Medicine, University College London, London, United Kingdom.'}, {'ForeName': 'Rebecca J', 'Initials': 'RJ', 'LastName': 'Beeken', 'Affiliation': 'Research Department of Behavioural Science and Health and.'}, {'ForeName': 'Andy', 'Initials': 'A', 'LastName': 'McEwen', 'Affiliation': 'National Centre for Smoking Cessation and Training, Dorchester, United Kingdom.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Baldwin', 'Affiliation': 'Respiratory Medicine Unit, David Evans Research Centre, Nottingham University Hospitals, Nottingham, United Kingdom.'}, {'ForeName': 'Angshu', 'Initials': 'A', 'LastName': 'Bhowmik', 'Affiliation': 'Department of Thoracic Medicine, Homerton University Hospital, London, United Kingdom.'}, {'ForeName': 'Neal', 'Initials': 'N', 'LastName': 'Navani', 'Affiliation': 'Department of Thoracic Medicine, University College London Hospital, London, United Kingdom.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Sennett', 'Affiliation': 'Killick Street Health Centre, London, United Kingdom.'}, {'ForeName': 'Stephen W', 'Initials': 'SW', 'LastName': 'Duffy', 'Affiliation': 'Wolfson Institute of Preventive Medicine, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, United Kingdom; and.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Wardle', 'Affiliation': 'Research Department of Behavioural Science and Health and.'}, {'ForeName': 'Jo', 'Initials': 'J', 'LastName': 'Waller', 'Affiliation': 'Research Department of Behavioural Science and Health and.'}, {'ForeName': 'Samuel M', 'Initials': 'SM', 'LastName': 'Janes', 'Affiliation': 'Lungs for Living Research Centre, UCL Respiratory, Division of Medicine, University College London, London, United Kingdom.'}]",American journal of respiratory and critical care medicine,['10.1164/rccm.201905-0946OC'] 262,31512258,Final analysis from RESONATE: Up to six years of follow-up on ibrutinib in patients with previously treated chronic lymphocytic leukemia or small lymphocytic lymphoma.,"Ibrutinib, a once-daily oral inhibitor of Bruton's tyrosine kinase, is approved in the United States and Europe for treatment of patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). The phase 3 RESONATE study showed improved efficacy of single-agent ibrutinib over ofatumumab in patients with relapsed/refractory CLL/SLL, including those with high-risk features. Here we report the final analysis from RESONATE with median follow-up on study of 65.3 months (range, 0.3-71.6) in the ibrutinib arm. Median progression-free survival (PFS) remained significantly longer for patients randomized to ibrutinib vs ofatumumab (44.1 vs 8.1 months; hazard ratio [HR]: 0.148; 95% confidence interval [CI]: 0.113-0.196; P˂.001). The PFS benefit with ibrutinib vs ofatumumab was preserved in the genomic high-risk population with del(17p), TP53 mutation, del(11q), and/or unmutated IGHV status (median PFS 44.1 vs 8.0 months; HR: 0.110; 95% CI: 0.080-0.152), which represented 82% of patients. Overall response rate with ibrutinib was 91% (complete response/complete response with incomplete bone marrow recovery, 11%). Overall survival, censored for crossover, was better with ibrutinib than ofatumumab (HR: 0.639; 95% CI: 0.418-0.975). With up to 71 months (median 41 months) of ibrutinib therapy, the safety profile remained consistent with prior reports; cumulatively, all-grade (grade ≥3) hypertension and atrial fibrillation occurred in 21% (9%) and 12% (6%) of patients, respectively. Only 16% discontinued ibrutinib because of adverse events (AEs). These long-term results confirm the robust efficacy of ibrutinib in relapsed/refractory CLL/SLL irrespective of high-risk clinical or genomic features, with no unexpected AEs. This trial is registered at www.clinicaltrials.gov (NCT01578707).",2019,"Overall survival, censored for crossover, was better with ibrutinib than ofatumumab (HR: 0.639; 95% CI: 0.418-0.975).","['patients with relapsed/refractory CLL/SLL, including those with high-risk features', 'patients with previously treated chronic lymphocytic leukemia or small lymphocytic lymphoma', 'patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL']",[],"['PFS benefit', 'Median progression-free survival (PFS', 'Overall response rate', 'Overall survival', 'grade (grade ≥3) hypertension and atrial fibrillation']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0023434', 'cui_str': 'Lymphoma, Small Lymphocytic'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0855095', 'cui_str': 'Malignant lymphoma, small lymphocytic (morphologic abnormality)'}]",[],"[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}]",,0.215249,"Overall survival, censored for crossover, was better with ibrutinib than ofatumumab (HR: 0.639; 95% CI: 0.418-0.975).","[{'ForeName': 'Talha', 'Initials': 'T', 'LastName': 'Munir', 'Affiliation': ""Department of Haematology, St. James's University Hospital, Leeds, UK.""}, {'ForeName': 'Jennifer R', 'Initials': 'JR', 'LastName': 'Brown', 'Affiliation': 'CLL Center, Dana-Farber Cancer Institute, Boston, Massachusetts.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': ""O'Brien"", 'Affiliation': 'UC Irvine, Chao Family Comprehensive Cancer Center, Irvine, California.'}, {'ForeName': 'Jacqueline C', 'Initials': 'JC', 'LastName': 'Barrientos', 'Affiliation': 'Division of Medical Oncology and Hematology Northwell Health Cancer Institute, Lake Success, New York.'}, {'ForeName': 'Paul M', 'Initials': 'PM', 'LastName': 'Barr', 'Affiliation': 'Wilmot Cancer Institute, University of Rochester Medical Center, Rochester, New York.'}, {'ForeName': 'Nishitha M', 'Initials': 'NM', 'LastName': 'Reddy', 'Affiliation': 'Vanderbilt-Ingram Cancer Center, Nashville, Tennessee.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Coutre', 'Affiliation': 'Stanford Cancer Center, Stanford University School of Medicine, Stanford, California.'}, {'ForeName': 'Constantine S', 'Initials': 'CS', 'LastName': 'Tam', 'Affiliation': ""Peter MacCallum Cancer Centre, St. Vincent's Hospital and University of Melbourne, Melbourne, Australia.""}, {'ForeName': 'Stephen P', 'Initials': 'SP', 'LastName': 'Mulligan', 'Affiliation': 'Royal North Shore Hospital, Sydney, Australia.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Jaeger', 'Affiliation': 'Division of Hematology and Hemostaseology, Medical University of Vienna, Wien, Austria.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Kipps', 'Affiliation': 'UCSD Moores Cancer Center, San Diego, California.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Moreno', 'Affiliation': 'Hospital de la Santa Creu i Sant Pau, Autonomous University of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Montillo', 'Affiliation': ""Niguarda Ca' Granda Hospital, Milan, Italy.""}, {'ForeName': 'Jan A', 'Initials': 'JA', 'LastName': 'Burger', 'Affiliation': 'Department of Leukemia, University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'John C', 'Initials': 'JC', 'LastName': 'Byrd', 'Affiliation': 'The Ohio State University Comprehensive Cancer Center, Columbus, Ohio.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Hillmen', 'Affiliation': 'The Leeds Teaching Hospitals, St. James Institute of Oncology, Leeds, UK.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Dai', 'Affiliation': 'Pharmacyclics LLC, an AbbVie Company, Sunnyvale, California.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Szoke', 'Affiliation': 'Pharmacyclics LLC, an AbbVie Company, Sunnyvale, California.'}, {'ForeName': 'James P', 'Initials': 'JP', 'LastName': 'Dean', 'Affiliation': 'Pharmacyclics LLC, an AbbVie Company, Sunnyvale, California.'}, {'ForeName': 'Jennifer A', 'Initials': 'JA', 'LastName': 'Woyach', 'Affiliation': 'The Ohio State University Comprehensive Cancer Center, Columbus, Ohio.'}]",American journal of hematology,['10.1002/ajh.25638'] 263,32301592,The safety and efficacy of zero-fluoroscopy ablation versus conventional ablation in patients with supraventricular tachycardia.,"BACKGROUND A zero fluoroscopy approach guided by a 3‑dimensional navigation system is an alternative to the traditional conventional fluoroscopy‑navigation approach for ablation of tachycardia. AIMS To compare the safety and efficacy of zero fluoroscopy ablation of supraventricular tachycardia (SVT) guided by the CARTO mapping system (CZF) alone, the EnSite zero fluoroscopy mapping system (EZF) alone, or the conventional fluoroscopy (CF) ablation method. METHODS From July 2015 to March 2017, patients admitted for SVT ablation were prospectively and consecutively enrolled in the CF, EZF, and CZF groups in a 1:1:1 ratio. The procedures for the CF group were performed using the traditional fluoroscopy method or the 3‑dimensional mapping method. All data were prospectively recorded by independent researchers. Procedure and fluoroscopic time as well as rate of success, recurrence, and complications in the 3 groups were analyzed. RESULTS One patient from the CZF group was moved to the CF group due to a severe venous malformation during catheter insertion. A total of 100 patients (100%) in the CF group, 100 patients (100%) in the EZF group (100%), and 99 patients (99%) in the CZF group successfully completed the electrophysiology study. There were no severe complications in any of the groups. The mean (SD) procedure time was 61.8 (36.2), 66.5 (24.2), and 65.4 (27.5) minutes in the CF, EZF, and CZF group, respectively. The median (interquartile range) fluoroscopy time of the CF group was 3.6 (2.1-8.8) minutes. CONCLUSIONS The zero fluoroscopy approach guided by the CARTO system is not inferior to the zero fluoroscopy approach guided by the EnSite system or a conventional fluoroscopic approach in terms of the efficiency and safety for ablation of SVT.",2020,A zero--fluoroscopic approach guided by the CARTOTM system is not inferior to a zero--fluoroscopic approach guided by the EnSiteTM system or a conventional fluoroscopic approach in terms of efficiency and safety for SVT ablation.,"['patients with supraventricular tachycardia', 'From July 2015 to March 2017, patients admitted for SVT ablation were consecutively enrolled in the CF, EZF, and CZF groups in a 1:1:1 ratio']","['zero fluoroscopic ablation of supraventricular tachycardia (SVT) guided by the CARTOTM mapping system (CZF) alone, the EnSiteTM zero fluoroscopic mapping system (EZF) alone, or the conventional fluoroscopy (CF) ablation method', 'CZF', 'CF', 'zero-fluoroscopy ablation versus conventional ablation', 'fluoroscopy radiofrequency catheter ablation']","['median/quartile fluoroscopy time', 'severe complications', 'safety and efficacy', 'severe venous malformation', 'mean (SD) procedure time', 'Procedure and fluoroscopic time, and rate of success, recurrence, and complications']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039240', 'cui_str': 'Supraventricular tachycardia'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0016356', 'cui_str': 'Fluoroscopy'}, {'cui': 'C0919414', 'cui_str': '0'}, {'cui': 'C1283195', 'cui_str': 'Mapping - action'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]","[{'cui': 'C0919414', 'cui_str': '0'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0039240', 'cui_str': 'Supraventricular tachycardia'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C1283195', 'cui_str': 'Mapping - action'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0016356', 'cui_str': 'Fluoroscopy'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0162561', 'cui_str': 'Radiofrequency Catheter Ablation'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0016356', 'cui_str': 'Fluoroscopy'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0265950', 'cui_str': 'Venous malformation'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}]",,0.0263017,A zero--fluoroscopic approach guided by the CARTOTM system is not inferior to a zero--fluoroscopic approach guided by the EnSiteTM system or a conventional fluoroscopic approach in terms of efficiency and safety for SVT ablation.,"[{'ForeName': 'Alselmi', 'Initials': 'A', 'LastName': 'Fadhle', 'Affiliation': ''}, {'ForeName': 'Mei', 'Initials': 'M', 'LastName': 'Hu', 'Affiliation': ''}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ''}]",Kardiologia polska,['10.33963/KP.15293'] 264,32299734,A randomized double-blinded non-inferiority trial comparing fentanyl and midazolam with pethidine and diazepam for pain relief during oocyte retrieval.,"RESEARCH QUESTION Is fentanyl and midazolam non-inferior to pethidine and diazepam in pain relief during oocyte retrieval under conscious sedation? DESIGN A randomized double-blinded non-inferiority trial of 170 infertile women undergoing oocyte retrieval under conscious sedation in an assisted reproduction centre. The women were randomized to receive intravenously either 0.1 mg fentanyl and 5 mg midazolam or 25 mg pethidine and 5 mg diazepam, plus paracervical block with 10 ml 1% lignocaine. The primary outcome was abdominal pain level during retrieval assessed by linear visual analogue scale from 0-10. Secondary outcomes included vaginal pain levels during and after retrieval and postoperative abdominal pain levels and side-effects, satisfaction level, clinical pregnancy and ongoing pregnancy rates. A pre-defined non-inferiority margin of 1 for the difference in pain levels between two groups was set. RESULTS Vaginal and abdominal pain levels during retrieval were significantly lower in the fentanyl and midazolam group compared with the pethidine and diazepam group (per-protocol analysis, vaginal pain: 1.6 versus 4.3; mean difference: -2.7, 95% CI -3.7, -1.8; P < 0.001; abdominal pain: 2.9 versus 5.2; mean difference: -2.3, 95% CI -3.3 to -1.3; P < 0.001 for non-inferiority). No differences were observed in these pain levels after retrieval. Most women experienced no postoperative side-effects. The fentanyl and midazolam group had better sedation level, satisfaction level on pain relief and satisfaction on the overall retrieval procedure than the pethidine and diazepam group. No significant differences were found in clinical pregnancy and ongoing pregnancy rates between the two groups. CONCLUSION The fentanyl and midazolam group had significantly lower vaginal and abdominal pain levels during oocyte retrieval than the pethidine and diazepam group.",2020,The fentanyl and midazolam group had significantly lower vaginal and abdominal pain levels during oocyte retrieval than the pethidine and diazepam group.,"['pain relief during oocyte retrieval', '170 infertile women undergoing oocyte retrieval under conscious sedation in an assisted reproduction centre']","['pethidine and 5 mg diazepam, plus paracervical block with 10 ml 1% lignocaine', 'fentanyl and 5 mg midazolam', 'pethidine', 'pethidine and diazepam', 'midazolam', 'diazepam', 'fentanyl and midazolam']","['postoperative side-effects', 'clinical pregnancy and ongoing pregnancy rates', 'pain levels', 'Vaginal and abdominal pain levels', 'vaginal and abdominal pain levels', 'vaginal pain levels during and after retrieval and postoperative abdominal pain levels and side-effects, satisfaction level, clinical pregnancy and ongoing pregnancy rates', 'abdominal pain', 'abdominal pain level during retrieval assessed by linear visual analogue scale', 'sedation level, satisfaction level on pain relief and satisfaction on the overall retrieval procedure']","[{'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0404268', 'cui_str': 'Oocyte recovery'}, {'cui': 'C4517599', 'cui_str': '170'}, {'cui': 'C0021359', 'cui_str': 'Sterility'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0079159', 'cui_str': 'Conscious sedation'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0035150', 'cui_str': 'Reproduction'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0025376', 'cui_str': 'Meperidine'}, {'cui': 'C0012010', 'cui_str': 'Diazepam'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0030401', 'cui_str': 'Paracervical block anesthesia'}, {'cui': 'C2744579', 'cui_str': 'ATP8A2 protein, human'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0026056', 'cui_str': 'Midazolam'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rates'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0000737', 'cui_str': 'Abdominal pain'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0236082', 'cui_str': 'Vaginal pain'}, {'cui': 'C4047372', 'cui_str': 'Postoperative abdominal pain'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0025664', 'cui_str': 'methods'}]",170.0,0.597173,The fentanyl and midazolam group had significantly lower vaginal and abdominal pain levels during oocyte retrieval than the pethidine and diazepam group.,"[{'ForeName': 'Shui Fan', 'Initials': 'SF', 'LastName': 'Lai', 'Affiliation': 'Department of Obstetrics and Gynaecology, Kwong Wah Hospital, 25 Waterloo Road, Yau Ma Tei Kowloon, Hong Kong; Department of Obstetrics and Gynaecology, the University of Hong Kong, Hong Kong. Electronic address: lsf087@ha.org.hk.'}, {'ForeName': 'Mei Ting', 'Initials': 'MT', 'LastName': 'Lam', 'Affiliation': 'Department of Obstetrics and Gynaecology, Kwong Wah Hospital, 25 Waterloo Road, Yau Ma Tei Kowloon, Hong Kong; Department of Obstetrics and Gynaecology, the University of Hong Kong, Hong Kong.'}, {'ForeName': 'Hang Wun Raymond', 'Initials': 'HWR', 'LastName': 'Li', 'Affiliation': 'Department of Obstetrics and Gynaecology, Kwong Wah Hospital, 25 Waterloo Road, Yau Ma Tei Kowloon, Hong Kong; Department of Obstetrics and Gynaecology, the University of Hong Kong, Hong Kong.'}, {'ForeName': 'Ernest Hung Yu', 'Initials': 'EHY', 'LastName': 'Ng', 'Affiliation': 'Department of Obstetrics and Gynaecology, the University of Hong Kong, Hong Kong.'}]",Reproductive biomedicine online,['10.1016/j.rbmo.2020.01.021'] 265,31573746,"Response-adapted treatment with rituximab, bendamustine, mitoxantrone, and dexamethasone followed by rituximab maintenance in patients with relapsed or refractory follicular lymphoma after first-line immunochemotherapy: Results of the RBMDGELTAMO08 phase II trial.","BACKGROUND Consensus is lacking regarding the optimal salvage therapy for patients with follicular lymphoma who relapse after or are refractory to immunochemotherapy. METHODS This phase II trial evaluated the efficacy and safety of response-adapted therapy with rituximab, bendamustine, mitoxantrone, and dexamethasone (RBMD) in follicular lymphoma patients who relapsed after or were refractory to first-line immunochemotherapy. Sixty patients received three treatment cycles, and depending on their response received an additional one (complete/unconfirmed complete response) or three (partial response) cycles. Patients who responded to induction received rituximab maintenance therapy for 2 years. RESULTS Thirty-three (55%) and 42 (70%) patients achieved complete/unconfirmed complete response after three cycles and on completing induction therapy (4-6 cycles), respectively (final overall response rate, 88.3%). Median progression-free survival was 56.4 months (median follow-up, 28.3 months; 95% CI, 15.6-51.2). Overall survival was not reached. Progression-free survival did not differ between patients who received four vs six cycles (P = .6665), nor between patients who did/did not receive rituximab maintenance after first-line therapy (P = .5790). Median progression-free survival in the 10 refractory patients was 25.5 months (95% CI, 0.6-N/A) and was longer in patients who had shown progression of disease after 24 months of first-line therapy (median, 56.4 months; 95% CI, 19.8-56.4) than in those who showed early progression (median, 42.31 months; 95% CI, 24.41-NA) (P = .4258). Thirty-six (60%) patients had grade 3/4 neutropenia. Grade 3/4 febrile neutropenia and infection were recorded during induction (4/60 [6.7%] and 5/60 [8.3%] patients, respectively) and maintenance (2/43 [4.5%] and 4/43 [9.1%] patients, respectively). CONCLUSIONS This response-adapted treatment with RBMD followed by rituximab maintenance is an effective and well-tolerated salvage treatment for relapsed/refractory follicular lymphoma following first-line immunochemotherapy. CLINICAL TRIAL REGISTRATION ClinicalTrials.gov # NCT01133158.",2019,"Progression-free survival did not differ between patients who received four vs six cycles (P = .6665), nor between patients who did/did not receive rituximab maintenance after first-line therapy (P = .5790).","['follicular lymphoma patients who relapsed after or were refractory to first-line immunochemotherapy', 'Thirty-three (55%) and 42 (70%) patients', 'patients with follicular lymphoma who relapse after or are refractory to immunochemotherapy', 'patients with relapsed or refractory follicular lymphoma after first-line immunochemotherapy']","['rituximab maintenance therapy', 'rituximab, bendamustine, mitoxantrone, and dexamethasone (RBMD', 'rituximab, bendamustine, mitoxantrone, and dexamethasone']","['Median progression-free survival', 'Progression-free survival', 'Grade 3/4 febrile neutropenia and infection', 'grade 3/4 neutropenia', 'progression of disease', 'Overall survival']","[{'cui': 'C0024301', 'cui_str': 'Brill-Symmers Disease'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C4087148', 'cui_str': 'Immunochemotherapy'}, {'cui': 'C0450358', 'cui_str': '33 (qualifier value)'}]","[{'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0677908', 'cui_str': 'Maintenance therapy'}, {'cui': 'C0525079', 'cui_str': 'bendamustine'}, {'cui': 'C0026259', 'cui_str': 'Mitoxantrone'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0442757', 'cui_str': '3/4'}, {'cui': 'C0746883', 'cui_str': 'Febrile Neutropenia'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",60.0,0.11169,"Progression-free survival did not differ between patients who received four vs six cycles (P = .6665), nor between patients who did/did not receive rituximab maintenance after first-line therapy (P = .5790).","[{'ForeName': 'Francisco-Javier', 'Initials': 'FJ', 'LastName': 'Peñalver', 'Affiliation': 'Hospital Universitario Fundación Alcorcón, Alcorcón, Madrid, Spain.'}, {'ForeName': 'José-Antonio', 'Initials': 'JA', 'LastName': 'Márquez', 'Affiliation': 'Hospital de Basurto, Vizcaya, Spain.'}, {'ForeName': 'Soledad', 'Initials': 'S', 'LastName': 'Durán', 'Affiliation': 'Complejo Hospitalario de Jaén, Jaén, Spain.'}, {'ForeName': 'Pilar', 'Initials': 'P', 'LastName': 'Giraldo', 'Affiliation': 'Hospital Universitario Miguel Servet, Zaragoza, Spain.'}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Martín', 'Affiliation': 'Hospital Universitario de Salamanca, IBSAL, CIBERONC, Salamanca, Spain.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Montalbán', 'Affiliation': 'Hospital Universitario Ramón y Cajal, Madrid, Spain.'}, {'ForeName': 'Juan-Manuel', 'Initials': 'JM', 'LastName': 'Sancho', 'Affiliation': 'ICO-IJC Hospital Germans Trias i Pujol, Badalona, Barcelona, Spain.'}, {'ForeName': 'María-José', 'Initials': 'MJ', 'LastName': 'Ramírez', 'Affiliation': 'Hospital de Especialidades de Jerez de la Frontera, Cádiz, Spain.'}, {'ForeName': 'María-José', 'Initials': 'MJ', 'LastName': 'Terol', 'Affiliation': 'Hospital Clínico Universitario de Valencia, Valencia, Spain.'}, {'ForeName': 'Francisco-Javier', 'Initials': 'FJ', 'LastName': 'Capote', 'Affiliation': 'Hospital Puerta del Mar, Cádiz, Spain.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Gutiérrez', 'Affiliation': 'Hospital Universitario Son Dureta, Palma de Mallorca, Spain.'}, {'ForeName': 'Blanca', 'Initials': 'B', 'LastName': 'Sánchez', 'Affiliation': 'Hospital del Mar, Barcelona, Spain.'}, {'ForeName': 'Andrés', 'Initials': 'A', 'LastName': 'López', 'Affiliation': ""Hospital Vall d'Hebron, Barcelona, Spain.""}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Salar', 'Affiliation': 'Hospital del Mar, Barcelona, Spain.'}, {'ForeName': 'Gil', 'Initials': 'G', 'LastName': 'Rodríguez-Caravaca', 'Affiliation': 'Universidad Rey Juan Carlos, Madrid, Spain.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Canales', 'Affiliation': 'Hospital Universitario La Paz, Madrid, Spain.'}, {'ForeName': 'María-Dolores', 'Initials': 'MD', 'LastName': 'Caballero', 'Affiliation': 'Hospital Universitario de Salamanca, IBSAL, CIBERONC, Salamanca, Spain.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Cancer medicine,['10.1002/cam4.2555'] 266,32303867,First trial outcome but not training difficulty predicts performance in goldfish visual discrimination.,"The easy-to-hard effect in perceptual learning shows that training with easier examples can facilitate initially difficult or impossible distinctions between very similar stimuli. This effect has been reported in humans and other species. We tested whether easy-to-hard training could facilitate visual discrimination in common goldfish (Carassius auratus). Fish (n = 6) performed a two-alternative forced choice discrimination task, which consisted of simultaneously presenting two striped patterns at a constant distance away on the outside of the tank. Fish were required to approach and bite a porthole corresponding to one of the stimuli for a food reward. Half of the fish were randomly assigned to a training schedule where stimuli became more similar as training progressed. The rest were trained only on the most difficult to distinguish version of the stimuli. All fish received a similar total amount of training regardless of the assigned schedule. We also examined whether performance on the first training trial for a given day was related to overall performance. Contrary to our hypothesis, fish in the easy-to-hard group did not perform significantly better than those in the constant-hard group. However, performance was found to be significantly higher on days when the first trial was correct compared to days on which it was incorrect, regardless of the type of training schedule. The current results contribute to understanding individual differences in perceptual learning in fish, and are consistent with research in humans, and other species, reporting better learning after initial reward.",2020,"Contrary to our hypothesis, fish in the easy-to-hard group did not perform significantly better than those in the constant-hard group.",['Fish (n\u2009'],[],['goldfish visual discrimination'],"[{'cui': 'C0016163', 'cui_str': 'Fish'}]",[],"[{'cui': 'C0018038', 'cui_str': 'Carassius auratus'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0012632', 'cui_str': 'Cognitive discrimination'}]",,0.0379904,"Contrary to our hypothesis, fish in the easy-to-hard group did not perform significantly better than those in the constant-hard group.","[{'ForeName': 'Milen L', 'Initials': 'ML', 'LastName': 'Radell', 'Affiliation': 'Department of Psychology, Niagara University, Lewiston, NY, 14109, USA. mradell@niagara.edu.'}, {'ForeName': 'Brian M', 'Initials': 'BM', 'LastName': 'McGuire', 'Affiliation': 'Department of Psychology, Niagara University, Lewiston, NY, 14109, USA.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Fisher-Thompson', 'Affiliation': 'Department of Psychology, Niagara University, Lewiston, NY, 14109, USA.'}]",Animal cognition,['10.1007/s10071-020-01380-5'] 267,31429205,Phase I trial of TAK-385 in hormone treatment-naïve Japanese patients with nonmetastatic prostate cancer.,"This open-label, phase I dose-finding study evaluated the gonadotropin-releasing hormone antagonist, TAK-385, in Japanese patients with nonmetastatic prostate cancer. In a two-part design, patients received daily oral TAK-385 at doses of 320 (loading, day 1)/80 (maintenance, day 2 and thereafter), 320/120, 320/160, or 360/120 mg for 28 days in a dose-escalation phase (part A, n = 13), and at 320/80 or 320/120 mg for up to 96 weeks in a randomized expansion phase (part B, n = 30). Primary endpoint in both parts was safety, including dose-limiting toxicity in part A. Secondary endpoints included pharmacokinetics, pharmacodynamics, and prostate-specific antigen concentration. Ten (77%) patients in part A and all patients in part B experienced an adverse event; hot flush (part A, n = 4; part B, n = 15), viral upper respiratory tract infection (part A, n = 1; part B, n = 10), and diarrhea (part B, n = 8) were most frequent. No dose-limiting toxicities were observed (part A). In 12 evaluable patients (part A), TAK-385 was rapidly absorbed after a single loading dose; on day 28 (maintenance dose), median steady-state T max was ~1-2 hours and mean t 1/2z was 67-79 hours. All doses rapidly reduced testosterone concentrations to castration levels within 1 week. Durable reductions in prostate-specific antigen of >90% from baseline were observed through 96 weeks. TAK-385 appeared tolerable and resulted in sustained reductions in testosterone to castration levels at all doses. The lowest loading/maintenance dose required for a clinical effect was 320/80 mg. ClinicalTrials.gov: NCT02141659.",2019,"Ten (77%) patients in part A and all patients in part B experienced an adverse event; hot flush (part A, n = 4; part B, n = 15), viral upper respiratory tract infection (part A, n = 1; part B, n = 10), and diarrhea (part B, n = 8) were most frequent.","['Japanese patients with nonmetastatic prostate cancer', 'hormone treatment-naïve Japanese patients with nonmetastatic prostate cancer']","['gonadotropin-releasing hormone antagonist, TAK-385', 'TAK-385', 'daily oral TAK-385']","['viral upper respiratory tract infection', 'testosterone concentrations to castration levels', 'No dose-limiting toxicities', 'pharmacokinetics, pharmacodynamics, and prostate-specific antigen concentration', 'safety, including dose-limiting toxicity', 'diarrhea', 'median steady-state T max']","[{'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C0019932', 'cui_str': 'Hormones'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C4543260', 'cui_str': 'Gonadotropin'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0522259', 'cui_str': 'Hormone antagonist'}, {'cui': 'C3252109', 'cui_str': 'TAK 385'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}]","[{'cui': 'C0339916', 'cui_str': 'Viral upper respiratory tract infection (disorder)'}, {'cui': 'C0523912', 'cui_str': 'Testosterone measurement (procedure)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0007344', 'cui_str': 'Gonadectomy'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0439801', 'cui_str': 'Limited (qualifier value)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0138741', 'cui_str': 'gamma-Seminoprotein'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0205361', 'cui_str': 'Steady (qualifier value)'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0806909', 'cui_str': 'Max'}]",,0.0198171,"Ten (77%) patients in part A and all patients in part B experienced an adverse event; hot flush (part A, n = 4; part B, n = 15), viral upper respiratory tract infection (part A, n = 1; part B, n = 10), and diarrhea (part B, n = 8) were most frequent.","[{'ForeName': 'Hiroyoshi', 'Initials': 'H', 'LastName': 'Suzuki', 'Affiliation': 'Department of Urology, Toho University Sakura Medical Center, Chiba, Japan.'}, {'ForeName': 'Hiroji', 'Initials': 'H', 'LastName': 'Uemura', 'Affiliation': 'Department of Urology and Renal Transplantation, Yokohama City University Medical Center, Yokohama, Japan.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Mizokami', 'Affiliation': 'Department of Integrative Cancer Therapy and Urology, Graduate School of Medical Sciences, Kanazawa University, Kanazawa, Japan.'}, {'ForeName': 'Narihiko', 'Initials': 'N', 'LastName': 'Hayashi', 'Affiliation': 'Department of Urology, Public University Corporation Yokohama City University Hospital, Yokohama, Japan.'}, {'ForeName': 'Yasuhide', 'Initials': 'Y', 'LastName': 'Miyoshi', 'Affiliation': 'Department of Urology and Renal Transplantation, Yokohama City University Medical Center, Yokohama, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Nagamori', 'Affiliation': 'Department of Urology, Incorporated Administrative Agency National Hospital Organization Hokkaido Cancer Center, Sapporo, Japan.'}, {'ForeName': 'Yutaka', 'Initials': 'Y', 'LastName': 'Enomoto', 'Affiliation': 'Department of Urology, Mitsui Memorial Hospital, Tokyo, Japan.'}, {'ForeName': 'Hideyuki', 'Initials': 'H', 'LastName': 'Akaza', 'Affiliation': 'Department of Strategic Investigation on Comprehensive Cancer Network, Interfaculty Initiative in Information Studies/Graduate School of Interdisciplinary Information Studies, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Takayuki', 'Initials': 'T', 'LastName': 'Asato', 'Affiliation': 'Oncology Clinical Research Department, Oncology Therapeutic Area Unit for Japan and Asia, Takeda Pharmaceutical Company Limited, Osaka, Japan.'}, {'ForeName': 'Tadayuki', 'Initials': 'T', 'LastName': 'Kitagawa', 'Affiliation': 'Japan Development Center, Takeda Pharmaceutical Company Limited, Osaka, Japan.'}, {'ForeName': 'Kazuhiro', 'Initials': 'K', 'LastName': 'Suzuki', 'Affiliation': 'Department of Urology, Graduate School of Medicine, National University Corporation Gunma University, Maebashi, Japan.'}]",Cancer medicine,['10.1002/cam4.2442'] 268,32301137,Overall safety of relamorelin in adults with diabetic gastroparesis: Analysis of phase 2a and 2b trial data.,"BACKGROUND Relamorelin, a pentapeptide ghrelin receptor agonist, accelerated gastric emptying significantly and improved symptoms in adults with diabetic gastroparesis in phase 2 trials. AIM To assess the safety and tolerability of relamorelin across phase 2 trials. METHODS Safety assessments in patients aged 18-75 years (weight, adverse events [AEs] and laboratory tests) from two randomised, double-blind phase 2 trials (NCT01571297, NCT02357420; results published previously) were reviewed descriptively. Analysis of covariance assessed treatment effect on glycated haemoglobin (HbA1c) and blood glucose post hoc. Phase 2a and 2b trial durations were, respectively, 4 weeks (relamorelin 10 µg once or twice daily [b.d.] or placebo b.d.) and 12 weeks (relamorelin 10, 30 or 100 µg or placebo b.d.) with 1- and 2-week, single-blind placebo run-ins. RESULTS Among 204 phase 2a and 393 phase 2b patients, respectively, 67% and 62% were female, and 88% and 89% had type 2 diabetes. Proportions of patients reporting serious AEs were similar across treatment groups, as were those with ≥1 treatment-emergent AE (TEAE). TEAE-related discontinuations were proportionally higher in relamorelin groups than placebo. Of 12 serious TEAEs in phase 2a, none occurred in >1 patient. In phase 2b, five serious TEAEs were reported in >1 patient, and one (100 µg) died (urosepsis), all unrelated to relamorelin. In phase 2b, increased HbA1c and fasting blood glucose levels were dose-related (P < 0.0001 and P = 0.0043, respectively). CONCLUSIONS Relamorelin showed acceptable safety and tolerability in phase 2 trials. Relamorelin may elevate blood glucose: this should be managed proactively in relamorelin-treated patients.",2020,"In phase 2b, increased HbA1c and fasting blood glucose levels were dose-related (P < 0.0001 and P = 0.0043, respectively). ","['adults with diabetic gastroparesis', '204 phase 2a and 393 phase 2b patients, respectively, 67% and 62% were female, and 88% and 89% had type 2 diabetes', 'adults with diabetic gastroparesis in phase\xa02 trials', 'patients aged 18-75\xa0years (weight, adverse events [AEs] and laboratory tests']","['Relamorelin', 'placebo', 'relamorelin', 'placebo b.d.) and 12\xa0weeks (relamorelin 10, 30 or 100\xa0µg or placebo b.d.) with 1- and 2-week, single-blind placebo run-ins']","['Overall safety', 'glycated haemoglobin (HbA1c) and blood glucose post hoc', 'TEAE-related discontinuations', 'blood glucose', 'safety and tolerability', 'acceptable safety and tolerability', 'HbA1c and fasting blood glucose levels']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0267176', 'cui_str': 'Gastroparesis with diabetes mellitus'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C4517754', 'cui_str': '393'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0282460', 'cui_str': 'Clinical Trials, Phase II as Topic'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0022885', 'cui_str': 'Laboratory procedure'}]","[{'cui': 'C4045486', 'cui_str': 'relamorelin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0242570', 'cui_str': 'Single-Masked Study'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C3539083', 'cui_str': 'Acceptable'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}]",,0.432022,"In phase 2b, increased HbA1c and fasting blood glucose levels were dose-related (P < 0.0001 and P = 0.0043, respectively). ","[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Camilleri', 'Affiliation': 'Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Lembo', 'Affiliation': 'Division of Gastroenterology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'McCallum', 'Affiliation': 'Division of Gastroenterology, Texas Tech University Health Sciences Center, El Paso, TX, USA.'}, {'ForeName': 'Stavros', 'Initials': 'S', 'LastName': 'Tourkodimitris', 'Affiliation': 'Biostatistics, Allergan plc, Madison, NJ, USA.'}, {'ForeName': 'Lara', 'Initials': 'L', 'LastName': 'Kemps', 'Affiliation': 'Clinical Development, Allergan plc, Madison, NJ, USA.'}, {'ForeName': 'Matthew B', 'Initials': 'MB', 'LastName': 'Miller', 'Affiliation': 'Chemistry, Manufacturing and Controls, Allergan plc, Madison, NJ, USA.'}, {'ForeName': 'Kirk', 'Initials': 'K', 'LastName': 'Bertelsen', 'Affiliation': 'Clinical Pharmacology, Allergan plc, Madison, NJ, USA.'}, {'ForeName': 'Alexandru', 'Initials': 'A', 'LastName': 'Iacob', 'Affiliation': 'Medical Safety, Allergan plc, Madison, NJ, USA.'}]",Alimentary pharmacology & therapeutics,['10.1111/apt.15711'] 269,31436395,Burden of hospitalization in acute lymphoblastic leukemia patients treated with Inotuzumab Ozogamicin versus standard chemotherapy treatment.,"BACKGROUND Inotuzumab Ozogamicin (INO), has demonstrated an improvement in overall survival, high rate of complete remission, favorable patient-reported outcomes, and manageable safety profile vs standard of care (SoC; intensive chemotherapy) for relapsed/refractory (R/R) acute lymphoblastic leukemia (ALL) in the phase 3 INO-VATE trial. With a one-hour weekly dosing schedule, INO might be associated with lower healthcare system burden. This study analyses hospitalizations for INO vs SoC. METHODS All patients receiving study treatment in the INO-VATE trial were included. The days hospitalized during study treatment was calculated. Due to different treatment durations for INO and SoC (median of 3 vs 1 cycles), number of hospital days was mainly reported per observed patient month. Hospital days per patient month were analyzed for different treatment cycles, subgroups, and main reasons for hospitalization. Differences between treatments were analyzed by the incidence rate ratio (IRR). RESULTS Overall, 82.9% and 94.4% INO and SoC patients experienced at least one hospitalization. The mean hospitalization days per patient month was 7.6 and 18.4 days for INO and SoC (IRR = 0.413, P < .001), which corresponds to patients spending 25.0% and 60.5% of their treatment time in a hospital. Main hospitalization reasons were R/R ALL treatment (5.2 (INO) vs 14.0 (SoC) days, IRR = 0.368, P < .001), treatment toxicities (1.4 vs 2.8 days, IRR = 0.516, P < .001) or other reasons (1.0 vs 1.6 days, IRR 0.629, P < .001). CONCLUSIONS Inotuzumab Ozogamicin treatment in R/R ALL is associated with a lower hospitalization burden compared with SoC. It is likely this lower burden has a favorable impact on healthcare budgets and cost-effectiveness considerations.",2019,"CONCLUSIONS Inotuzumab Ozogamicin treatment in R/R ALL is associated with a lower hospitalization burden compared with SoC.","['All patients receiving study treatment in the INO-VATE trial were included', 'acute lymphoblastic leukemia patients treated with']","['Inotuzumab Ozogamicin', 'Inotuzumab Ozogamicin versus standard chemotherapy treatment']","['number of hospital days', 'incidence rate ratio (IRR', 'overall survival', 'treatment toxicities', 'mean hospitalization days per patient month', 'Burden of hospitalization']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1961102', 'cui_str': 'Lymphocytic Leukemia, Acute'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}]","[{'cui': 'C1567130', 'cui_str': 'inotuzumab ozogamicin'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0083017', 'cui_str': 'IRR'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]",,0.0439669,"CONCLUSIONS Inotuzumab Ozogamicin treatment in R/R ALL is associated with a lower hospitalization burden compared with SoC.","[{'ForeName': 'David I', 'Initials': 'DI', 'LastName': 'Marks', 'Affiliation': 'Bristol Haematology and Oncology Centre, University Hospitals Bristol NHS Foundation Trust, Bristol, UK.'}, {'ForeName': 'Ilse', 'Initials': 'I', 'LastName': 'van Oostrum', 'Affiliation': 'Ingress-Health Nederland B.V., Rotterdam, The Netherlands.'}, {'ForeName': 'Sabrina', 'Initials': 'S', 'LastName': 'Mueller', 'Affiliation': 'Ingress-Health HWM GmbH, Wismar, Germany.'}, {'ForeName': 'Verna', 'Initials': 'V', 'LastName': 'Welch', 'Affiliation': 'Pfizer Global HEOR, New York, NY, USA.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Vandendries', 'Affiliation': 'Pfizer Inc, Cambridge, MA, USA.'}, {'ForeName': 'Fausto R', 'Initials': 'FR', 'LastName': 'Loberiza', 'Affiliation': 'Pfizer Inc, Pharma GmbH, Berlin, Germany.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Böhme', 'Affiliation': 'Pfizer Deutschland GmbH, Berlin, Germany.'}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Su', 'Affiliation': 'Independent, Bridgewater, NJ, USA.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Stelljes', 'Affiliation': 'Universitätsklinikum Münster, Münster, Germany.'}, {'ForeName': 'Hagop M', 'Initials': 'HM', 'LastName': 'Kantarjian', 'Affiliation': 'University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}]",Cancer medicine,['10.1002/cam4.2480'] 270,32303737,"Within-Patient, Single-Blinded, Randomized Controlled Clinical Trial to Evaluate the Efficacy of Triamcinolone Acetonide Injections for the Treatment of Hypertrophic Scar in Adult Burn Survivors.","Intralesional corticosteroid (triamcinolone acetonide [TAC]) injections have become one of the cornerstone treatments of hypertrophic scar (HSc). However, the evidence is of limited-quality, and published investigations have almost exclusively been performed in linear scars rather than hypertrophic burn scars. Thus, the aim of this study was to perform an appropriately powered, single-blinded, randomized controlled trial to evaluate the impact of TAC injections on burn HSc compared with patient-matched usual care control scars. Fifty burn survivors with two scars (separated by nonscarred skin preferably on the contralateral side or an anatomically similar site) were selected based on high-frequency ultrasound thickness (>2.034 mm to ensure that the site was outside of the range of normal scar). Pretreatment thickness measurements of the two sites were within 0.5 mm of each other, to ensure homogeneity and an erythema index >300 to establish they were immature HSc. The sites were randomly assigned to treatment or control. The treatment HSc received a 10 mg/ml TAC. When necessary, the injection was repeated after 6 weeks and a third final injection 6 weeks later. Objective evaluation of thickness, elasticity, erythema, and melanin was obtained at the treatment and control sites at pretreatment, posttreatment, and follow-up 6 weeks after the last injection. Thirty participants completed the study, reaching the required number for an adequately powered sample based on pilot study data analyses. Ten participants received only one injection, 27 received only two injections, and 13 received three injections of TAC. Analysis of covariance comparing the treatment vs control HSc posttreatment, controlling for pretreatment values and Fitzpatrick skin type, revealed a significant decrease in thickness and increase in elasticity of the treated compared with control HSc (P = .0003), but no significant difference in erythema or melanin. Pretreatment to posttreatment comparisons using paired t-tests revealed a significant decrease in thickness of both the treated and control HSc, an increase in elasticity of the treated HSc during the treatment period, but no significant change in the control HSc elasticity or erythema of either site, and a significant increase in melanin of both the treated (P < .001) and control (P = .02) HSc. A regression model for repeated measures, controlling for pretreatment values and skin type, revealed no significant change in thickness, elasticity, erythema, or melanin during the 6-week follow-up. Although thickness decreased at both the treated and control HSc across time, there was a significantly greater reduction at the TAC injected HSc and a significantly greater increase in elasticity. Melanin significantly increased at both the treatment and control site. There was no significant change during the follow-up period of any of the HSc characteristics.",2020,"Pretreatment to posttreatment comparisons using paired t-tests revealed a significant decrease in thickness of both the treated and control HSc, an increase in elasticity of the treated HSc during the treatment period, but no significant change in the control HSc elasticity or erythema of either site, and a significant increase in melanin of both the treated (P < .001) and control (P = .02) HSc.","['Fifty burn survivors with two scars (separated by nonscarred skin preferably on the contralateral side or an anatomically similar site) were selected based on high-frequency ultrasound thickness (>2.034 mm to ensure that the site was outside of the range of normal scar', 'Thirty participants completed the study, reaching the required number for an adequately powered sample based on pilot study data analyses', 'patient-matched usual care control scars', 'Adult Burn Survivors']","['Intralesional corticosteroid (triamcinolone acetonide [TAC]) injections', 'TAC', 'ml TAC', 'TAC injections', 'Triamcinolone Acetonide Injections']","['thickness of both the treated and control HSc', 'elasticity', 'erythema or melanin', 'thickness, elasticity, erythema, or melanin', 'thickness, elasticity, erythema, and melanin', 'Melanin', 'melanin', 'elasticity of the treated HSc', 'control HSc elasticity or erythema']","[{'cui': 'C0000912', 'cui_str': 'Accident caused by unspecified fire'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0008767', 'cui_str': 'Scarring'}, {'cui': 'C0443299', 'cui_str': 'Separate'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0441988', 'cui_str': 'Contralateral'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205212', 'cui_str': 'High frequency'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0032863', 'cui_str': 'Power (Psychology)'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0031928', 'cui_str': 'Pilot Study'}, {'cui': 'C0010992', 'cui_str': 'Data Analysis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C1512955', 'cui_str': 'Intralesional route'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0040866', 'cui_str': 'Triamcinolone acetonide'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C3489891', 'cui_str': 'TAC Alternate'}]","[{'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0162810', 'cui_str': 'Hypertrophic scar'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0025196', 'cui_str': 'Melanin'}]",,0.0315162,"Pretreatment to posttreatment comparisons using paired t-tests revealed a significant decrease in thickness of both the treated and control HSc, an increase in elasticity of the treated HSc during the treatment period, but no significant change in the control HSc elasticity or erythema of either site, and a significant increase in melanin of both the treated (P < .001) and control (P = .02) HSc.","[{'ForeName': 'Bernadette', 'Initials': 'B', 'LastName': 'Nedelec', 'Affiliation': 'School of Physical and Occupational Therapy, McGill University, Montreal, Canada.'}, {'ForeName': 'Leo', 'Initials': 'L', 'LastName': 'LaSalle', 'Affiliation': 'Hôpital de réadaptation Villa Medica, Montreal, Canada.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'de Oliveira', 'Affiliation': 'Hôpital de réadaptation Villa Medica, Montreal, Canada.'}, {'ForeName': 'José A', 'Initials': 'JA', 'LastName': 'Correa', 'Affiliation': 'Department of Mathematics and Statistics, McGill University, Montreal, Canada.'}]",Journal of burn care & research : official publication of the American Burn Association,['10.1093/jbcr/iraa057'] 271,31568675,Testosterone therapy induces molecular programming augmenting physiological adaptations to resistance exercise in older men.,"BACKGROUND The andropause is associated with declines in serum testosterone (T), loss of muscle mass (sarcopenia), and frailty. Two major interventions purported to offset sarcopenia are anabolic steroid therapies and resistance exercise training (RET). Nonetheless, the efficacy and physiological and molecular impacts of T therapy adjuvant to short-term RET remain poorly defined. METHODS Eighteen non-hypogonadal healthy older men, 65-75 years, were assigned in a random double-blinded fashion to receive, biweekly, either placebo (P, saline, n = 9) or T (Sustanon 250 mg, n = 9) injections over 6 week whole-body RET (three sets of 8-10 repetitions at 80% one-repetition maximum). Subjects underwent dual-energy X-ray absorptiometry, ultrasound of vastus lateralis (VL) muscle architecture, and knee extensor isometric muscle force tests; VL muscle biopsies were taken to quantify myogenic/anabolic gene expression, anabolic signalling, muscle protein synthesis (D 2 O), and breakdown (extrapolated). RESULTS Testosterone adjuvant to RET augmented total fat-free mass (P=0.007), legs fat-free mass (P=0.02), and appendicular fat-free mass (P=0.001) gains while decreasing total fat mass (P=0.02). Augmentations in VL muscle thickness, fascicle length, and quadriceps cross-section area with RET occured to a greater extent in T (P < 0.05). Sum strength (P=0.0009) and maximal voluntary contract (e.g. knee extension at 70°) (P=0.002) increased significantly more in the T group. Mechanistically, both muscle protein synthesis rates (T: 2.13 ± 0.21%·day -1 vs. P: 1.34 ± 0.13%·day -1 , P=0.0009) and absolute breakdown rates (T: 140.2 ± 15.8 g·day -1 vs. P: 90.2 ± 11.7 g·day -1 , P=0.02) were elevated with T therapy, which led to higher net turnover and protein accretion in the T group (T: 8.3 ± 1.4 g·day -1 vs. P: 1.9 ± 1.2 g·day -1 , P=0.004). Increases in ribosomal biogenesis (RNA:DNA ratio); mRNA expression relating to T metabolism (androgen receptor: 1.4-fold; Srd5a1: 1.6-fold; AKR1C3: 2.1-fold; and HSD17β3: two-fold); insulin-like growth factor (IGF)-1 signalling [IGF-1Ea (3.5-fold) and IGF-1Ec (three-fold)] and myogenic regulatory factors; and the activity of anabolic signalling (e.g. mTOR, AKT, and RPS6; P < 0.05) were all up-regulated with T therapy. Only T up-regulated mitochondrial citrate synthase activity (P=0.03) and transcription factor A (1.41 ± 0.2-fold, P=0.0002), in addition to peroxisome proliferator-activated receptor-γ co-activator 1-α mRNA (1.19 ± 0.21-fold, P=0.037). CONCLUSIONS Administration of T adjuvant to RET enhanced skeletal muscle mass and performance, while up-regulating myogenic gene programming, myocellular translational efficiency and capacity, collectively resulting in higher protein turnover, and net protein accretion. T coupled with RET is an effective short-term intervention to improve muscle mass/function in older non-hypogonadal men.",2019,Sum strength (P=0.0009) and maximal voluntary contract (e.g. knee extension at 70°) (P=0.002) increased significantly more in the T group.,"['Eighteen non-hypogonadal healthy older men, 65-75 years', 'older non-hypogonadal men', 'older men']","['placebo (P, saline, n = 9) or T (Sustanon 250 mg, n = 9) injections over 6 week whole-body RET', 'RET', 'sarcopenia are anabolic steroid therapies and resistance exercise training (RET', 'dual-energy X-ray absorptiometry, ultrasound of vastus lateralis (VL) muscle architecture, and knee extensor isometric muscle force tests; VL muscle biopsies', 'Testosterone therapy']","['Sum strength', 'muscle protein synthesis rates', 'total fat-free mass', 'serum testosterone (T), loss of muscle mass (sarcopenia), and frailty', 'absolute breakdown rates', 'legs fat-free mass', 'mitochondrial citrate synthase activity', 'net turnover and protein accretion', 'total fat mass', 'maximal voluntary contract', 'VL muscle thickness, fascicle length, and quadriceps cross-section area with RET']","[{'cui': 'C3715206', 'cui_str': 'Eighteen'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0075665', 'cui_str': 'Sustanon'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0444584', 'cui_str': 'Whole body (qualifier value)'}, {'cui': 'C0543431', 'cui_str': 'ret (qualifier value)'}, {'cui': 'C0872084', 'cui_str': 'Sarcopenias'}, {'cui': 'C0002845', 'cui_str': 'Anabolic Steroids'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C1510486', 'cui_str': 'Dual X-Ray Absorptiometry'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0224444', 'cui_str': 'Vastus Lateralis'}, {'cui': 'C0003737', 'cui_str': 'Architecture'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0443221', 'cui_str': 'Forced (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0185283', 'cui_str': 'Biopsy of muscle (procedure)'}, {'cui': 'C0523912', 'cui_str': 'Testosterone measurement (procedure)'}]","[{'cui': 'C0026832', 'cui_str': 'Muscle Proteins'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0424679', 'cui_str': 'Fat-free mass (observable entity)'}, {'cui': 'C0428413', 'cui_str': 'Serum testosterone measurement'}, {'cui': 'C0240417', 'cui_str': 'Form of muscle (finding)'}, {'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0312285', 'cui_str': 'Citrate (re)-synthase (substance)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0443331', 'cui_str': 'Turnover technique (qualifier value)'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0333038', 'cui_str': 'Accretion'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0439656', 'cui_str': 'Voluntary (qualifier value)'}, {'cui': 'C0332522', 'cui_str': 'Contracts'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0205203', 'cui_str': 'Crossed (qualifier value)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0543431', 'cui_str': 'ret (qualifier value)'}]",,0.0510255,Sum strength (P=0.0009) and maximal voluntary contract (e.g. knee extension at 70°) (P=0.002) increased significantly more in the T group.,"[{'ForeName': 'Nima', 'Initials': 'N', 'LastName': 'Gharahdaghi', 'Affiliation': 'MRC-ARUK Centre for Musculoskeletal Ageing Research and Nottingham NIHR BRC, School of Medicine, University of Nottingham, Derby, UK.'}, {'ForeName': 'Supreeth', 'Initials': 'S', 'LastName': 'Rudrappa', 'Affiliation': 'MRC-ARUK Centre for Musculoskeletal Ageing Research and Nottingham NIHR BRC, School of Medicine, University of Nottingham, Derby, UK.'}, {'ForeName': 'Matthew S', 'Initials': 'MS', 'LastName': 'Brook', 'Affiliation': 'MRC-ARUK Centre for Musculoskeletal Ageing Research and Nottingham NIHR BRC, School of Medicine, University of Nottingham, Derby, UK.'}, {'ForeName': 'Iskandar', 'Initials': 'I', 'LastName': 'Idris', 'Affiliation': 'MRC-ARUK Centre for Musculoskeletal Ageing Research and Nottingham NIHR BRC, School of Medicine, University of Nottingham, Derby, UK.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Crossland', 'Affiliation': 'MRC-ARUK Centre for Musculoskeletal Ageing Research and Nottingham NIHR BRC, School of Medicine, University of Nottingham, Derby, UK.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Hamrock', 'Affiliation': 'Institute of Food and Health, University College Dublin, Belfield, Dublin, Ireland.'}, {'ForeName': 'Muhammad Hariz', 'Initials': 'MH', 'LastName': 'Abdul Aziz', 'Affiliation': 'MRC-ARUK Centre for Musculoskeletal Ageing Research and Nottingham NIHR BRC, School of Medicine, University of Nottingham, Derby, UK.'}, {'ForeName': 'Fawzi', 'Initials': 'F', 'LastName': 'Kadi', 'Affiliation': 'Division of Sports Sciences, School of Health and Medical Sciences, Örebro University, Örebro, Sweden.'}, {'ForeName': 'Janelle', 'Initials': 'J', 'LastName': 'Tarum', 'Affiliation': 'Division of Sports Sciences, School of Health and Medical Sciences, Örebro University, Örebro, Sweden.'}, {'ForeName': 'Paul L', 'Initials': 'PL', 'LastName': 'Greenhaff', 'Affiliation': 'MRC-ARUK Centre for Musculoskeletal Ageing Research, School of Life Sciences, University of Nottingham, Nottingham, Nottingham, UK.'}, {'ForeName': 'Dumitru', 'Initials': 'D', 'LastName': 'Constantin-Teodosiu', 'Affiliation': 'MRC-ARUK Centre for Musculoskeletal Ageing Research, School of Life Sciences, University of Nottingham, Nottingham, Nottingham, UK.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Cegielski', 'Affiliation': 'MRC-ARUK Centre for Musculoskeletal Ageing Research and Nottingham NIHR BRC, School of Medicine, University of Nottingham, Derby, UK.'}, {'ForeName': 'Bethan E', 'Initials': 'BE', 'LastName': 'Phillips', 'Affiliation': 'MRC-ARUK Centre for Musculoskeletal Ageing Research and Nottingham NIHR BRC, School of Medicine, University of Nottingham, Derby, UK.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Wilkinson', 'Affiliation': 'MRC-ARUK Centre for Musculoskeletal Ageing Research and Nottingham NIHR BRC, School of Medicine, University of Nottingham, Derby, UK.'}, {'ForeName': 'Nathaniel J', 'Initials': 'NJ', 'LastName': 'Szewczyk', 'Affiliation': 'MRC-ARUK Centre for Musculoskeletal Ageing Research and Nottingham NIHR BRC, School of Medicine, University of Nottingham, Derby, UK.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Smith', 'Affiliation': 'MRC-ARUK Centre for Musculoskeletal Ageing Research and Nottingham NIHR BRC, School of Medicine, University of Nottingham, Derby, UK.'}, {'ForeName': 'Philip J', 'Initials': 'PJ', 'LastName': 'Atherton', 'Affiliation': 'MRC-ARUK Centre for Musculoskeletal Ageing Research and Nottingham NIHR BRC, School of Medicine, University of Nottingham, Derby, UK.'}]","Journal of cachexia, sarcopenia and muscle",['10.1002/jcsm.12472'] 272,31568698,"Whey protein isolate supplementation improves body composition, muscle strength, and treatment tolerance in malnourished advanced cancer patients undergoing chemotherapy.","In recent years, whey proteins (WP) have attracted increasing attention in health and disease for their bioactive functions. The aim of this study was to evaluate the benefit of WP isolate (WPI) supplementation in addition to nutritional counseling in malnourished advanced cancer patients undergoing chemotherapy (CT). In a single-center, randomized, pragmatic, and parallel-group controlled trial (ClinicalTrials.gov: NCT02065726), 166 malnourished advanced cancer patients with mixed tumor entities candidate to or undergoing CT were randomly assigned to receive nutritional counseling with (N = 82) or without (N = 84) WPI supplementation (20 g/d) for 3 months. The primary endpoint was the change in phase angle (PhA). Secondary endpoints included changes in standardized PhA (SPA), fat-free mass index (FFMI), body weight, muscle strength, and CT toxicity (CTCAE 4.0 events). In patients with the primary endpoint assessed (modified intention-to-treat population), counseling plus WPI (N = 66) resulted in improved PhA compared to nutritional counseling alone (N = 69): mean difference, 0.48° (95% CI, 0.05 to 0.90) (P = .027). WPI supplementation also resulted in improved SPA (P = .021), FFMI (P = .041), body weight (P = .023), muscle strength (P < .001), and in a reduced risk of CT toxicity (risk difference, -9.8% [95% CI, -16.9 to -2.6]; P = .009), particularly of severe (grade ≥ 3) events (risk difference, -30.4% [95% CI, -44.4 to -16.5]; P = .001). In malnourished advanced cancer patients undergoing CT, receiving nutritional counseling, a 3-month supplementation with WPI resulted in improved body composition, muscle strength, body weight, and reduced CT toxicity. Further trials, aimed at verifying the efficacy of this nutritional intervention on mid- and long-term primary clinical endpoints in newly diagnosed specific cancer types, are warranted.",2019,"WPI supplementation also resulted in improved SPA (P = .021), FFMI (P = .041), body weight (P = .023), muscle strength (P < .001), and in a reduced risk of CT toxicity (risk difference, -9.8% [95% CI, -16.9 to -2.6]; P = .009), particularly of severe (grade ≥ ","['malnourished advanced cancer patients undergoing', 'malnourished advanced cancer patients undergoing chemotherapy (CT', '166 malnourished advanced cancer patients with mixed tumor entities candidate to or undergoing CT', 'malnourished advanced cancer patients undergoing chemotherapy', 'newly diagnosed specific cancer types']","['WP isolate (WPI) supplementation', 'nutritional counseling with (N\xa0=\xa082) or without (N\xa0=\xa084) WPI supplementation', 'nutritional intervention', 'CT, receiving nutritional counseling', 'Whey protein isolate supplementation']","['FFMI', 'change in phase angle (PhA', 'SPA', 'modified intention-to-treat population), counseling plus WPI', 'body composition, muscle strength, body weight, and reduced CT toxicity', 'body weight', 'body composition, muscle strength, and treatment tolerance', 'changes in standardized PhA (SPA), fat-free mass index (FFMI), body weight, muscle strength, and CT toxicity (CTCAE 4.0 events', 'muscle strength', 'risk of CT toxicity']","[{'cui': 'C0162429', 'cui_str': 'Malnutrition'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0026277', 'cui_str': 'Syringoma, Chondroid'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}]","[{'cui': 'C0205409', 'cui_str': 'Isolated (qualifier value)'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0078479', 'cui_str': 'Whey Proteins'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0205143', 'cui_str': 'Angular (qualifier value)'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0231197', 'cui_str': 'Tolerance, function (observable entity)'}, {'cui': 'C0424679', 'cui_str': 'Fat-free mass (observable entity)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",,0.127147,"WPI supplementation also resulted in improved SPA (P = .021), FFMI (P = .041), body weight (P = .023), muscle strength (P < .001), and in a reduced risk of CT toxicity (risk difference, -9.8% [95% CI, -16.9 to -2.6]; P = .009), particularly of severe (grade ≥ ","[{'ForeName': 'Emanuele', 'Initials': 'E', 'LastName': 'Cereda', 'Affiliation': 'Clinical Nutrition and Dietetics Unit, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.'}, {'ForeName': 'Annalisa', 'Initials': 'A', 'LastName': 'Turri', 'Affiliation': 'Clinical Nutrition and Dietetics Unit, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Klersy', 'Affiliation': 'Biometry and Clinical Epidemiology Service, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Cappello', 'Affiliation': 'Clinical Nutrition and Dietetics Unit, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Ferrari', 'Affiliation': 'Medical Oncology Unit, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.'}, {'ForeName': 'Andrea Riccardo', 'Initials': 'AR', 'LastName': 'Filippi', 'Affiliation': 'Radiation Oncology Unit, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Brugnatelli', 'Affiliation': 'Medical Oncology Unit, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.'}, {'ForeName': 'Marilisa', 'Initials': 'M', 'LastName': 'Caraccia', 'Affiliation': 'Clinical Nutrition and Dietetics Unit, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Chiellino', 'Affiliation': 'Medical Oncology Unit, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.'}, {'ForeName': 'Valeria', 'Initials': 'V', 'LastName': 'Borioli', 'Affiliation': 'Clinical Nutrition and Dietetics Unit, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Monaco', 'Affiliation': 'Medical Oncology Unit, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.'}, {'ForeName': 'Giulia Maria', 'Initials': 'GM', 'LastName': 'Stella', 'Affiliation': 'Unit of Respiratory System Diseases, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Arcaini', 'Affiliation': 'Division of Hematology, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Benazzo', 'Affiliation': 'Department of Otolaryngology, University of Pavia, Pavia, Italy.'}, {'ForeName': 'Giuseppina', 'Initials': 'G', 'LastName': 'Grugnetti', 'Affiliation': 'Nursing Technical and Rehabilitation Service, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Pedrazzoli', 'Affiliation': 'Medical Oncology Unit, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.'}, {'ForeName': 'Riccardo', 'Initials': 'R', 'LastName': 'Caccialanza', 'Affiliation': 'Clinical Nutrition and Dietetics Unit, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.'}]",Cancer medicine,['10.1002/cam4.2517'] 273,31407876,Inter-individual variability in response to exercise intervention or usual care in hospitalized older adults.,"BACKGROUND Exercise protocols applied during hospitalization can prevent functional and cognitive decline in older adults. The purpose of this study was to examine the individual response of acutely hospitalized patients to usual care and to physical exercise on functional capacity, muscle strength, and cognitive function and to assess the relationship with mortality at 1 year post-discharge. METHODS In a single-blind randomized clinical trial, 370 hospitalized patients [56.5% women; mean age (standard deviation) 87.3 (4.9) years] were allocated to an exercise intervention group (IG, n = 185) or a control group (CG, n = 185). The participants were older adults aged 75 years or older in an acute care unit in a tertiary public hospital in Navarra, Spain. The usual care group received habitual hospital care, which included physical rehabilitation when needed. The in-hospital intervention included individualized multicomponent exercise training programme performed during 5-7 consecutive days (two sessions/day). Functional capacity was assessed with the Short Physical Performance Battery (SPPB) test and the Gait Velocity Test (GVT). Handgrip strength and cognitive function were also measured at admission and discharge. Patients in both groups were categorized as responders (Rs), non-responders (NRs), and adverse responders (ARs) based on the individual response to each treatment during hospitalization. RESULTS The prevalence of Rs was higher and the prevalence of NRs and ARs was lower in the intervention group than in the control group for functional capacity (SPPB IG: Rs 85.3%, NRs 8.7%, ARs 6.0% vs. CG: Rs 37.9%, NRs 28.8%, ARs 33.3% and GVT IG: Rs 51.2%, NRs 47.3, ARs 1.6% vs. CG: Rs 18.0%, NRs 67.7%, ARs 14.3%), muscle strength (IG: Rs 62.3%, NRs 26.5%, ARs 11.3% vs. CG: Rs 20.0%, NRs 38.0%, ARs 42.0%), and cognition (IG: Rs 41.5%, NRs 57.1%, ARs 1.4% vs. CG: Rs 13.8%, NRs 76.6%, ARs 9.7%) (all P < 0.001). The ARs for the GVT in the control group and the ARs for the SPPB in the intervention group had a significantly higher rate of mortality than the NRs and Rs in the equivalent groups (0.01 and 0.03, respectively) at follow-up. CONCLUSIONS Older patients performing an individualized exercise intervention presented higher prevalence of Rs and a lower prevalence of NRs and ARs for functional capacity, muscle strength, and cognitive function than those who were treated with usual care during acute hospitalization. An adverse response on functional capacity in older patients to physical exercise or usual care during hospitalization was associated with mortality at 1 year post-discharge.",2019,"The prevalence of Rs was higher and the prevalence of NRs and ARs was lower in the intervention group than in the control group for functional capacity (SPPB IG: Rs 85.3%, NRs 8.7%, ARs 6.0% vs. CG: Rs 37.9%, NRs 28.8%, ARs 33.3% and GVT IG: Rs 51.2%, NRs 47.3, ARs 1.6% vs. CG:","['acutely hospitalized patients to usual care and to', '370 hospitalized patients [56.5% women; mean age (standard deviation) 87.3 (4.9) years', 'hospitalized older adults', 'older patients', 'Older patients performing an', 'older adults', 'participants were older adults aged 75 years or older in an acute care unit in a tertiary public hospital in Navarra, Spain']","['individualized exercise intervention', 'habitual hospital care, which included physical rehabilitation', 'physical exercise', 'exercise intervention', 'CG', 'individualized multicomponent exercise training programme']","['Functional capacity', 'Short Physical Performance Battery (SPPB) test and the Gait Velocity Test (GVT', 'functional capacity, muscle strength, and cognitive function', 'rate of mortality', 'prevalence of NRs and ARs', 'Handgrip strength and cognitive function', 'muscle strength']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4517743', 'cui_str': 'Three hundred and seventy'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0205372', 'cui_str': 'Tertiary (qualifier value)'}, {'cui': 'C0020022', 'cui_str': 'Hospitals, Public'}, {'cui': 'C0037747', 'cui_str': 'Spain'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0205353', 'cui_str': 'Habitual (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}]","[{'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C4075461', 'cui_str': 'Short Physical Performance Battery'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}]",370.0,0.0321945,"The prevalence of Rs was higher and the prevalence of NRs and ARs was lower in the intervention group than in the control group for functional capacity (SPPB IG: Rs 85.3%, NRs 8.7%, ARs 6.0% vs. CG: Rs 37.9%, NRs 28.8%, ARs 33.3% and GVT IG: Rs 51.2%, NRs 47.3, ARs 1.6% vs. CG:","[{'ForeName': 'Mikel L', 'Initials': 'ML', 'LastName': 'Sáez de Asteasu', 'Affiliation': 'Department of Health Sciences, Public University of Navarra, Pamplona, Navarra, Spain.'}, {'ForeName': 'Nicolás', 'Initials': 'N', 'LastName': 'Martínez-Velilla', 'Affiliation': 'Navarrabiomed, IdiSNA, Navarra Institute for Health Research, Pamplona, Navarra, Spain.'}, {'ForeName': 'Fabricio', 'Initials': 'F', 'LastName': 'Zambom-Ferraresi', 'Affiliation': 'Navarrabiomed, IdiSNA, Navarra Institute for Health Research, Pamplona, Navarra, Spain.'}, {'ForeName': 'Álvaro', 'Initials': 'Á', 'LastName': 'Casas-Herrero', 'Affiliation': 'Navarrabiomed, IdiSNA, Navarra Institute for Health Research, Pamplona, Navarra, Spain.'}, {'ForeName': 'Eduardo L', 'Initials': 'EL', 'LastName': 'Cadore', 'Affiliation': 'Federal University of the Rio Grande of Sul, Porto Alegre, Brazil.'}, {'ForeName': 'Robinson', 'Initials': 'R', 'LastName': 'Ramirez-Velez', 'Affiliation': 'Department of Health Sciences, Public University of Navarra, Pamplona, Navarra, Spain.'}, {'ForeName': 'Mikel', 'Initials': 'M', 'LastName': 'Izquierdo', 'Affiliation': 'Department of Health Sciences, Public University of Navarra, Pamplona, Navarra, Spain.'}]","Journal of cachexia, sarcopenia and muscle",['10.1002/jcsm.12481'] 274,31081593,Sodium-glucose co-transporter inhibitors as adjunctive treatment to insulin in type 1 diabetes: A review of randomized controlled trials.,"Many patients with type 1 diabetes (T1D) struggle to achieve glycaemic control and experience significant fluctuations in glucose concentrations, despite insulin treatment. Sodium-glucose co-transporter (SGLT)-2 inhibitors and dual SGLT-1/2 inhibitors increase glucose elimination via the kidneys and reduce hyperglycaemia via insulin-independent mechanisms. This review examines available efficacy and safety data for these agents under investigation as adjunctive therapy for T1D. Across randomized trials of up to 52 weeks, SGLT-2 inhibitors or SGLT-1/2 inhibitors as an adjunct to insulin demonstrated significant reductions in glycated haemoglobin, glucose exposure, and measures of glycaemic variability, as well as increased time in the target glycaemic range, compared with placebo. Non-glycaemic benefits included reductions in body weight and insulin doses, as well as improvements in some cardiovascular risk factors and treatment satisfaction. SGLT-2 inhibitors and SGLT-1/2 inhibitors were associated with similar rates of hypoglycaemia but a higher incidence of genitourinary infections, compared with placebo. Diabetic ketoacidosis occurred more often with SGLT-2 inhibitors and SGLT-1/2 inhibitors vs placebo, although the incidence was generally low. Risk mitigation strategies in light of clinical trial data are also discussed. Positive data from randomized controlled trials of the SGLT-2 inhibitor dapagliflozin have led to the approval of dapagliflozin as an adjunct to insulin in adults with T1D having body mass index ≥27 kg/m 2 in whom insulin does not provide adequate glycaemic control in Europe and to approval as an adjunct to insulin for adults with T1D in Japan.",2019,"SGLT-2 inhibitors and SGLT-1/2 inhibitors were associated with similar rates of hypoglycaemia but a higher incidence of genitourinary infections, compared with placebo.","['adults with T1D having body mass index ≥27\u2009kg/m 2 in whom', 'type 1 diabetes', 'adults with T1D in Japan']","['placebo', 'SGLT-2 inhibitor dapagliflozin', 'insulin', 'Sodium-glucose co-transporter (SGLT)-2 inhibitors and dual SGLT-1/2 inhibitors', 'Sodium-glucose co-transporter inhibitors']","['glycated haemoglobin, glucose exposure, and measures of glycaemic variability', 'Diabetic ketoacidosis', 'hypoglycaemia']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0441729', 'cui_str': 'Type 1 (qualifier value)'}, {'cui': 'C0022341', 'cui_str': 'Japan'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3273807', 'cui_str': 'Gliflozins'}, {'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C4301634', 'cui_str': 'Sodium-glucose co-transporter 2 (SGLT2) inhibitors'}, {'cui': 'C0580272', 'cui_str': '1/2'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C3541959', 'cui_str': 'Sodium supplement (substance)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0598849', 'cui_str': 'Co-Transporters'}]","[{'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0011880', 'cui_str': 'Ketosis, Diabetic'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}]",,0.209386,"SGLT-2 inhibitors and SGLT-1/2 inhibitors were associated with similar rates of hypoglycaemia but a higher incidence of genitourinary infections, compared with placebo.","[{'ForeName': 'Schafer', 'Initials': 'S', 'LastName': 'Boeder', 'Affiliation': 'Division of Endocrinology and Metabolism, University of California San Diego, San Diego, California.'}, {'ForeName': 'Steven V', 'Initials': 'SV', 'LastName': 'Edelman', 'Affiliation': 'Division of Endocrinology and Metabolism, University of California San Diego, San Diego, California.'}]","Diabetes, obesity & metabolism",['10.1111/dom.13749'] 275,31094083,Skeletal muscle mass loss and dose-limiting toxicities in metastatic colorectal cancer patients.,"BACKGROUND Increasing evidence suggests that severe skeletal muscle index (SMI) loss (sarcopenia) is associated with poor overall survival in metastatic colorectal cancer patients, but its mechanisms are unknown. We recently found, using data of the randomized phase 3 CAIRO3 study, that SMI loss was related with shorter time to disease progression and overall survival during first-line maintenance treatment with capecitabine + bevacizumab (CAP-B) or observation and during more intensive capecitabine + oxaliplatin + bevacizumab (CAPOX-B) reintroduction treatment. As a potential risk factor for reduced survival, we explored whether sarcopenia and SMI loss were associated with dose-limiting toxicities (DLTs) during CAP-B and CAPOX-B. METHODS Sarcopenia status and SMI loss were assessed by using consecutive computed tomography scans. DLTs were defined as any dose delay/reduction/discontinuation of systemic treatment because of reported CTCAE (version 3.0) toxicities at the start or during treatment. Poisson regression models were used to study whether sarcopenia and body mass index (BMI) at the start of treatment and SMI and BMI loss during treatment were associated with DLTs. RESULTS One hundred eighty-two patients (mean age 63.0 ± 8.8 years, 37% female) received CAP-B, and 232 patients (mean age 63.0 ± 9.0 years, 34% female) received CAPOX-B. At the start of CAP-B and CAPOX-B, 54% and 46% of patients were sarcopenic, respectively. Mean BMI was lower in sarcopenic patients, although patients were on average still overweight (sarcopenic vs. non-sarcopenic at the start of CAP-B 25.0 ± 3.9 vs. 26.7 ± 4.1 and CAPOX-B 25.8 ± 3.8 vs. 27.1 ± 3.8 kg/m 2 ). Sarcopenia at the start of CAP-B was not associated with DLTs [relative risk 0.87 (95% confidence interval 0.64-1.19)], whereas patients with >2% SMI loss had a significantly higher risk of DLTs [1.29 (1.01-1.66)]. At the start of subsequent CAPOX-B, 25% of patients received a dose reduction, and the risk of dose reduction was significantly higher for patients with preceding SMI loss [1.78 (1.06-3.01)] or sarcopenia [1.75 (1.08-2.86)]. After the received dose reductions, sarcopenia or SMI loss was not significantly associated with a higher risk of DLTs during CAPOX-B [sarcopenia vs. non-sarcopenic: 0.86 (0.69-1.08) and SMI loss vs. stable/gain: 0.83 (0.65-1.07)]. In contrast, BMI (loss) at the start or during either treatment was not associated with an increased risk of DLTs. CONCLUSIONS In this large longitudinal study in metastatic colorectal cancer patients during palliative systemic treatment, sarcopenia and/or muscle loss was associated with an increased risk of DLTs. BMI was not associated with DLTs and could not detect sarcopenia or SMI loss. Prospective (randomized) studies should reveal whether normalizing chemotherapeutic doses to muscle mass or muscle mass preservation (by exercise and nutritional interventions) increases chemotherapeutic tolerance and improves survival.",2019,"After the received dose reductions, sarcopenia or SMI loss was not significantly associated with a higher risk of DLTs during CAPOX-B [sarcopenia vs. non-sarcopenic: 0.86 (0.69-1.08) and SMI loss vs. stable/gain: 0.83 (0.65-1.07)].","['One hundred eighty-two patients (mean age 63.0\xa0±\xa08.8\xa0years, 37% female) received CAP-B, and 232 patients (mean age 63.0\xa0±\xa09.0\xa0years, 34% female) received', 'metastatic colorectal cancer patients']","['capecitabine\xa0+\xa0bevacizumab (CAP-B) or observation and during more intensive capecitabine\xa0+\xa0oxaliplatin\xa0+\xa0bevacizumab (CAPOX-B) reintroduction treatment', 'CAPOX-B']","['chemotherapeutic tolerance and improves survival', 'BMI', 'sarcopenia or SMI loss', 'Mean BMI', 'risk of dose reduction', 'toxicities', 'shorter time to disease progression and overall survival', 'SMI and BMI loss', 'sarcopenia and body mass index (BMI', 'risk of DLTs', 'Skeletal muscle mass loss and dose-limiting toxicities']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517882', 'cui_str': '8.8 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0179586', 'cui_str': 'Cap (physical object)'}, {'cui': 'C0346973', 'cui_str': 'Secondary malignant neoplasm of large intestine'}]","[{'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0179586', 'cui_str': 'Cap (physical object)'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0231197', 'cui_str': 'Tolerance, function (observable entity)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0872084', 'cui_str': 'Sarcopenias'}, {'cui': 'C0915075', 'cui_str': 'samarium diiodide'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0242656', 'cui_str': 'Disease Progression'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0242692', 'cui_str': 'Muscle, Voluntary'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}]",,0.0768099,"After the received dose reductions, sarcopenia or SMI loss was not significantly associated with a higher risk of DLTs during CAPOX-B [sarcopenia vs. non-sarcopenic: 0.86 (0.69-1.08) and SMI loss vs. stable/gain: 0.83 (0.65-1.07)].","[{'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Kurk', 'Affiliation': 'Department of Medical Oncology, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Peeters', 'Affiliation': 'Department of Epidemiology, Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Stellato', 'Affiliation': 'Department of Statistics, Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Dorresteijn', 'Affiliation': 'Danone Nutricia Research, Nutricia Advanced Medical Nutrition, Utrecht, The Netherlands.'}, {'ForeName': 'Pim', 'Initials': 'P', 'LastName': 'de Jong', 'Affiliation': 'Department of Radiology, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'Marion', 'Initials': 'M', 'LastName': 'Jourdan', 'Affiliation': 'Danone Nutricia Research, Nutricia Advanced Medical Nutrition, Utrecht, The Netherlands.'}, {'ForeName': 'Geert-Jan', 'Initials': 'GJ', 'LastName': 'Creemers', 'Affiliation': 'Department of Medical Oncology, Catharina Hospital, Eindhoven, The Netherlands.'}, {'ForeName': 'Frans', 'Initials': 'F', 'LastName': 'Erdkamp', 'Affiliation': 'Department of Medical Oncology, Zuyderland Hospital, Sittard-Geleen, The Netherlands.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'de Jongh', 'Affiliation': 'Department of Internal Medicine and Medical Oncology, Ikazia Hospital, Rotterdam, The Netherlands.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Kint', 'Affiliation': 'Department of Radiology, Amphia Hospital, Breda, The Netherlands.'}, {'ForeName': 'Lieke', 'Initials': 'L', 'LastName': 'Simkens', 'Affiliation': 'Department of Medical Oncology, Maxima Medical Center, Eindhoven, The Netherlands.'}, {'ForeName': 'Bea', 'Initials': 'B', 'LastName': 'Tanis', 'Affiliation': 'Department of Medical Oncology, Groenehart Hospital, Gouda, The Netherlands.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Tjin-A-Ton', 'Affiliation': 'Department of Medical Oncology, Rivierenland Hospital, Tiel, The Netherlands.'}, {'ForeName': 'Ankie', 'Initials': 'A', 'LastName': 'Van Der Velden', 'Affiliation': 'Department of Medical Oncology, Tergooi Hospital, Hilversum, The Netherlands.'}, {'ForeName': 'Cornelis', 'Initials': 'C', 'LastName': 'Punt', 'Affiliation': 'Department of Medical Oncology, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Koopman', 'Affiliation': 'Department of Medical Oncology, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'May', 'Affiliation': 'Department of Epidemiology, Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.'}]","Journal of cachexia, sarcopenia and muscle",['10.1002/jcsm.12436'] 276,31109915,Integrated stepped alcohol treatment for patients with HIV and alcohol use disorder: a randomised controlled trial.,"BACKGROUND We examined the effectiveness of integrated stepped alcohol treatment (ISAT) on alcohol use and HIV outcomes among patients living with HIV and alcohol use disorder. METHODS In this multisite, randomised controlled trial, conducted in five Veterans Affairs-based HIV clinics in the USA (Atlanta, GA; Brooklyn-Manhattan, NY; Dallas and Houston, TX; and Washington, DC), we recruited people living with HIV and an alcohol use disorder who were not otherwise receiving formal alcohol treatment. Patients were eligible if they were aged 18 years or older, HIV positive, English speaking, and met criteria for alcohol use disorder by the Diagnostic and Statistical Manual for Mental Disorders-IV criteria for alcohol abuse or dependence. Key exclusion criteria included if the patient was acutely suicidal or had a psychiatric condition that affected their ability to participate in counselling interventions, or if they had any medical conditions that would preclude completing the study or cause harm during the course of the study. Using a web-based clinical trial management system, we randomly assigned participants (1:1) to receive ISAT or treatment as usual; patients, investigators, and clinicians were unmasked to allocation. ISAT involved three steps: step 1, addiction physician management, comprising eight sessions; step 2, addiction physician management plus motivational enhancement therapy, comprising four sessions; and step 3, specialty referral. Participants were stepped up at weeks 4 and 12 if they exceeded a priori drinking criteria. Treatment as usual involved referral to substance use treatment services. The primary outcome was number of drinks per week over the past 30 days at week 24 by use of the timeline followback method, assessed in the intention-to-treat population. Adverse events were tracked throughout the study period in all randomly assigned participants. This trial is registered at ClinicalTrials.gov, number NCT01410123. FINDINGS Between Jan 28, 2013, and July 14, 2017, 128 of 351 patients assessed for eligibility were eligible and randomly assigned to receive ISAT (n=63) or treatment as usual (n=65). Mean age was 54 years (range 23-70), 125 (98%) of 128 participants were men, and 101 (79%) were black. 25 (20%) were lost to follow-up. In the ISAT group, of 57 participants who did not die or withdraw, 30 (52%) advanced to step 2, and 17 (57%) of 30 advanced to step 3. 32 (51%) of 63 participants assigned to ISAT versus 17 (26%) of 65 assigned to treatment as usual received at least one alcohol treatment medication (p=0·004). Participants in both groups decreased their alcohol consumption, but at week 24 we did not detect a difference in number of drinks per week between the groups (least squares mean 10·4 drinks per week [SD 16·5] in the ISAT group vs 15·6 drinks per week [SD 17·6] in the treatment as usual group; adjusted mean difference -4·2, 95% CI -9·4 to 0·9; p=0·11). One adverse event occurred that was possibly related to treatment occurred in the ISAT group (headache). INTERPRETATION ISAT increases the receipt of alcohol treatment medications and counselling without changes in drinking at week 24. Strategies to implement and enhance ISAT are needed. Future efforts should focus on promoting ISAT with attention to enhancing patient engagement and retention in alcohol-related care. FUNDING US National Institute on Alcohol Abuse and Alcoholism.",2019,"Participants in both groups decreased their alcohol consumption, but at week 24 we did not detect a difference in number of drinks per week between the groups (least squares mean 10·4 drinks per week [SD 16·5] in the ISAT group vs 15·6 drinks per week [SD 17·6] in the treatment as usual group; adjusted mean difference -4·2, 95% CI -9·4 to 0·9; p=0·11).","['patients living with HIV and alcohol use disorder', 'Between Jan 28, 2013, and July 14, 2017', 'Key exclusion criteria included if the patient was acutely suicidal or had a psychiatric condition that affected their ability to participate in counselling interventions, or if they had any medical conditions that would preclude completing the study or cause harm during the course of the study', 'Mean age was 54 years (range 23-70), 125 (98%) of 128 participants were men, and 101 (79%) were black', '57 participants who did not die or withdraw, 30 (52%) advanced to step 2, and 17 (57%) of 30 advanced to step 3', 'patients with HIV and alcohol use disorder', 'five Veterans Affairs-based HIV clinics in the USA (Atlanta, GA; Brooklyn-Manhattan, NY; Dallas and Houston, TX; and Washington, DC), we recruited people living with HIV and an alcohol use disorder who were not otherwise receiving formal alcohol treatment', '128 of 351 patients assessed for eligibility were eligible', 'Patients were eligible if they were aged 18 years or older, HIV positive, English speaking, and met criteria for alcohol use disorder by the Diagnostic and Statistical Manual for Mental Disorders-IV criteria for alcohol abuse or dependence']","['integrated stepped alcohol treatment (ISAT', 'ISAT', 'addiction physician management plus motivational enhancement therapy', 'Integrated stepped alcohol treatment']","['number of drinks', 'number of drinks per week over the past 30 days', 'alcohol consumption', 'Adverse events', 'alcohol use and HIV outcomes']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0001956', 'cui_str': 'Alcohol Use Disorder'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0438696', 'cui_str': 'Suicidal (finding)'}, {'cui': 'C0205487', 'cui_str': 'Psychiatric (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0347984', 'cui_str': 'During (attribute)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C4319551', 'cui_str': 'One hundred and twenty-five'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C1546956', 'cui_str': 'Dead (finding)'}, {'cui': 'C0424092', 'cui_str': 'Withdrawn (finding)'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0043038', 'cui_str': 'Washington'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0043237', 'cui_str': 'WHO'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0019699', 'cui_str': 'HTLV-III Seroconversion'}, {'cui': 'C3540738', 'cui_str': 'English [International Organization for Standardization 639-1 code en] language reference set (foundation metadata concept)'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}, {'cui': 'C0175674', 'cui_str': 'Manual (qualifier value)'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder (disorder)'}, {'cui': 'C0085762', 'cui_str': 'Alcohol abuse (disorder)'}, {'cui': 'C0439857', 'cui_str': 'Patient dependence on (contextual qualifier) (qualifier value)'}]","[{'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0085281', 'cui_str': 'Addictive Behavior'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1627358', 'cui_str': 'Refractive surgery enhancement'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0452428', 'cui_str': 'Drinks (substance)'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C1444637', 'cui_str': 'In the past'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}]",128.0,0.136665,"Participants in both groups decreased their alcohol consumption, but at week 24 we did not detect a difference in number of drinks per week between the groups (least squares mean 10·4 drinks per week [SD 16·5] in the ISAT group vs 15·6 drinks per week [SD 17·6] in the treatment as usual group; adjusted mean difference -4·2, 95% CI -9·4 to 0·9; p=0·11).","[{'ForeName': 'E Jennifer', 'Initials': 'EJ', 'LastName': 'Edelman', 'Affiliation': 'Yale School of Medicine, New Haven, CT, USA; Center for Interdisciplinary Research on AIDS, Yale School of Public Health, New Haven, CT, USA. Electronic address: ejennifer.edelman@yale.edu.'}, {'ForeName': 'Stephen A', 'Initials': 'SA', 'LastName': 'Maisto', 'Affiliation': 'Syracuse University, Syracuse, NY, USA.'}, {'ForeName': 'Nathan B', 'Initials': 'NB', 'LastName': 'Hansen', 'Affiliation': 'Center for Interdisciplinary Research on AIDS, Yale School of Public Health, New Haven, CT, USA; College of Public Health, University of Georgia, Athens, GA, USA.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Cutter', 'Affiliation': 'Yale School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Dziura', 'Affiliation': 'Yale School of Medicine, New Haven, CT, USA; Yale Center for Analytic Sciences, Yale University School of Public Health, New Haven, CT, USA.'}, {'ForeName': 'Yanhong', 'Initials': 'Y', 'LastName': 'Deng', 'Affiliation': 'Yale Center for Analytic Sciences, Yale University School of Public Health, New Haven, CT, USA.'}, {'ForeName': 'Lynn E', 'Initials': 'LE', 'LastName': 'Fiellin', 'Affiliation': 'Yale School of Medicine, New Haven, CT, USA; Center for Interdisciplinary Research on AIDS, Yale School of Public Health, New Haven, CT, USA.'}, {'ForeName': 'Patrick G', 'Initials': 'PG', 'LastName': ""O'Connor"", 'Affiliation': 'Yale School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Bedimo', 'Affiliation': 'Veterans Affairs North Texas Health Care System and UT Southwestern, Dallas, TX, USA.'}, {'ForeName': 'Cynthia L', 'Initials': 'CL', 'LastName': 'Gibert', 'Affiliation': 'Washington DC Veterans Affairs Medical Center and George Washington University School of Medicine and Health Sciences, Washington, DC, USA.'}, {'ForeName': 'Vincent C', 'Initials': 'VC', 'LastName': 'Marconi', 'Affiliation': 'Atlanta Veterans Affairs Medical Center and Emory University School of Medicine, Atlanta, GA, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Rimland', 'Affiliation': 'Atlanta Veterans Affairs Medical Center and Emory University School of Medicine, Atlanta, GA, USA.'}, {'ForeName': 'Maria C', 'Initials': 'MC', 'LastName': 'Rodriguez-Barradas', 'Affiliation': 'Michael E DeBakey Veterans Affairs Medical Center and Baylor College of Medicine, Houston, TX, USA.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Simberkoff', 'Affiliation': 'Veterans Affairs NY Harbor Healthcare System and New York University School of Medicine, New York, NY, USA.'}, {'ForeName': 'Janet P', 'Initials': 'JP', 'LastName': 'Tate', 'Affiliation': 'Yale School of Medicine, New Haven, CT, USA; Veterans Affairs Connecticut Healthcare System, Veterans Aging Cohort Study, West Haven, CT, USA.'}, {'ForeName': 'Amy C', 'Initials': 'AC', 'LastName': 'Justice', 'Affiliation': 'Yale School of Medicine, New Haven, CT, USA; Center for Interdisciplinary Research on AIDS, Yale School of Public Health, New Haven, CT, USA; Veterans Affairs Connecticut Healthcare System, Veterans Aging Cohort Study, West Haven, CT, USA.'}, {'ForeName': 'Kendall J', 'Initials': 'KJ', 'LastName': 'Bryant', 'Affiliation': 'National Institute on Alcohol Abuse and Alcoholism HIV/AIDS Program, Bethesda, MD, USA.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Fiellin', 'Affiliation': 'Yale School of Medicine, New Haven, CT, USA; Center for Interdisciplinary Research on AIDS, Yale School of Public Health, New Haven, CT, USA.'}]",The lancet. HIV,['10.1016/S2352-3018(19)30076-1'] 277,31358922,Progression and new onset of macular retinoschisis in myopic choroidal neovascularization eyes after Conbercept therapy: a post-hoc analysis.,"OBJECTIVES The objective of this study is to evaluate the progression and new onset of macular retinoschisis (MRS) in the patients treated with intravitreal Conbercept injections for myopic choroidal neovascularization (mCNV). METHODS Post-hoc analysis of 160 mCNV patients included in SHINY study was performed to evaluate the impact of Conbercept injection on MRS in patients with mCNV undergoing intravitreal Conbercept injections. The patients were 3:1 randomized to the study group (three loading dose and thereafter pro re nata [PRN]) and the control group (3 months' sham injection, then one Conbercept injection at month 4 and thereafter PRN). MRS was assessed with optical coherence tomography by masked graders. RESULTS At baseline, 28 of 122 eyes in study group and 10 of 38 eyes in control group had MRS. At month 3, two patients showed MRS progression and one patient had new onset MRS in study group. No MRS progression nor new onset MRS was found in the control group. At final visit, the cumulative incidence of MRS was 1.3% (2/160). Both Spearman's correlation and multiple logistic regression demonstrated no association between the progression and new onset of MRS and intravitreal injection frequency (correlation coefficient = 0.017, P = 0.851 and odds ratio = 0.996, P = 0.982). In addition, baseline vitreoretinal adhesion was the most likely potential risk factor resulting in MRS progression (odds ratio = 4.566, P = 0.027). Furthermore, MRS progression was more likely to take place in outer retinal layers. CONCLUSIONS The progression and new onset of MRS was not associated with the frequency of intravitreal Conbercept injections.",2020,No MRS progression nor new onset MRS was found in the control group.,"['myopic choroidal neovascularization eyes after Conbercept therapy', '160 mCNV patients included in SHINY study', 'for myopic choroidal neovascularization (mCNV', 'patients with mCNV undergoing intravitreal Conbercept injections']","['Conbercept injection on MRS', 'intravitreal Conbercept injections']","['MRS', 'cumulative incidence of MRS', 'progression and new onset of MRS and intravitreal injection frequency', 'MRS progression nor new\xa0onset MRS', 'MRS progression', 'new onset MRS']","[{'cui': 'C3665926', 'cui_str': 'Myopic choroidal neovascularization'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C2352201', 'cui_str': 'KH902 fusion protein'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}]","[{'cui': 'C2352201', 'cui_str': 'KH902 fusion protein'}, {'cui': 'C1272883', 'cui_str': 'Injection'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0332162', 'cui_str': 'Onset of (contextual qualifier) (qualifier value)'}, {'cui': 'C1554888', 'cui_str': 'Intravitreal Injections'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}]",,0.0474506,No MRS progression nor new onset MRS was found in the control group.,"[{'ForeName': 'Yanping', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': ""Department of Ophthalmology, Shanghai General Hospital (Shanghai First People's Hospital), Shanghai Jiao Tong University School of Medicine, Shanghai, China.""}, {'ForeName': 'Shiqi', 'Initials': 'S', 'LastName': 'Yang', 'Affiliation': ""Department of Ophthalmology, Shanghai General Hospital (Shanghai First People's Hospital), Shanghai Jiao Tong University School of Medicine, Shanghai, China.""}, {'ForeName': 'Yuanzhi', 'Initials': 'Y', 'LastName': 'Yuan', 'Affiliation': 'Department of Ophthalmology, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Minlu', 'Initials': 'M', 'LastName': 'Song', 'Affiliation': ""Department of Ophthalmology, Shanghai General Hospital (Shanghai First People's Hospital), Shanghai Jiao Tong University School of Medicine, Shanghai, China.""}, {'ForeName': 'Fenglei', 'Initials': 'F', 'LastName': 'Kuang', 'Affiliation': 'R&D Center, Chengdu Kanghong Biotech Ltd., Sichuan, China.'}, {'ForeName': 'Kun', 'Initials': 'K', 'LastName': 'Liu', 'Affiliation': ""Department of Ophthalmology, Shanghai General Hospital (Shanghai First People's Hospital), Shanghai Jiao Tong University School of Medicine, Shanghai, China.""}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Zhang', 'Affiliation': 'Department of Ophthalmology, Beijing Tongren Hospital, Capital Medical University, Peking, China.'}, {'ForeName': 'Fenghua', 'Initials': 'F', 'LastName': 'Wang', 'Affiliation': ""Department of Ophthalmology, Shanghai General Hospital (Shanghai First People's Hospital), Shanghai Jiao Tong University School of Medicine, Shanghai, China. shretina@sjtu.edu.cn.""}, {'ForeName': 'Xiaodong', 'Initials': 'X', 'LastName': 'Sun', 'Affiliation': ""Department of Ophthalmology, Shanghai General Hospital (Shanghai First People's Hospital), Shanghai Jiao Tong University School of Medicine, Shanghai, China. xdsun@sjtu.edu.cn.""}]","Eye (London, England)",['10.1038/s41433-019-0516-x'] 278,31320735,Intravitreal dexamethasone implant as an alternative to systemic steroids as prophylaxis for uveitic cataract surgery: a randomized trial.,"PURPOSE To determine the utility of the dexamethasone implant (IVD) as an alternative to systemic steroids as prophylaxis against cystoid macular edema (CMO) in patients with chronic, recurrent CMO associated intermediate or posterior uveitis (IU/PU), and cataract undergoing cataract surgery. METHODS This was a randomized, parallel design, and clinical trial. Patients with IU/PU and cataract scheduled for cataract surgery were randomly assigned to receive the IVD concurrently with cataract surgery (Group 1: 20 patients) or systemic steroids (Group 2: 23 patients) tapered over 4-6 weeks along with uneventful cataract surgery and routine postoperative care. Patients with glaucoma/contraindications to steroids were excluded. All patients were followed up for 6 months. OUTCOME MEASURE Primary-incidence of postoperative CMO. Secondary-the change in BCVA (corrected distance visual acuity) and Central Subfield thickness (CST) and complications. Appropriate statistical analysis was done. RESULTS The median age was 47.3 ± 4.23 years (group 1) and 49.12 ± 5.32 years (Group 2). One patient (Group 1) and two (Group 2) developed CMO. The BCVA improved significantly in both groups (p = 0.013). The CST change was insignificant. Four patients (Group 1) required intraocular pressure (IOP) lowering medications. Three patients (Group 2) required early steroid taper. CONCLUSIONS IVD is a good alternative as prophylaxis in IU/PU and cataract in preventing postoperative CMO.",2020,The BCVA improved significantly in both groups (p = 0.013).,"['uveitic cataract surgery', 'Patients with IU/PU and cataract scheduled for cataract surgery', 'The median age was 47.3\u2009±\u20094.23 years (group 1) and 49.12\u2009±\u20095.32 years (Group 2', 'Patients with glaucoma/contraindications to steroids were excluded', 'patients with chronic, recurrent CMO associated intermediate or posterior uveitis (IU/PU), and cataract undergoing cataract surgery']","['dexamethasone implant (IVD', 'IVD concurrently with cataract surgery', 'systemic steroids (Group 2: 23 patients) tapered over 4-6 weeks along with uneventful cataract surgery and routine postoperative care', 'Intravitreal dexamethasone implant']","['CMO', 'BCVA', 'postoperative CMO', 'BCVA (corrected distance visual acuity) and Central Subfield thickness (CST) and complications', 'intraocular pressure (IOP) lowering medications']","[{'cui': 'C2004600', 'cui_str': 'Cataract surgery specialty'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0856347', 'cui_str': 'Right cataract'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0441861', 'cui_str': 'Group 1 (qualifier value)'}, {'cui': 'C0441865', 'cui_str': 'Group 2 (qualifier value)'}, {'cui': 'C2242746', 'cui_str': 'Glaucoma (SMQ)'}, {'cui': 'C0522473', 'cui_str': 'Contraindication to (contextual qualifier) (qualifier value)'}, {'cui': 'C0038317', 'cui_str': 'Steroids'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0042167', 'cui_str': 'Uveitis, Posterior'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C2828363', 'cui_str': 'Implant'}, {'cui': 'C2004600', 'cui_str': 'Cataract surgery specialty'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0038317', 'cui_str': 'Steroids'}, {'cui': 'C0441865', 'cui_str': 'Group 2 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0032786', 'cui_str': 'Postoperative Care'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}, {'cui': 'C0429537', 'cui_str': 'Distance visual acuity (observable entity)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0021888', 'cui_str': 'Ocular Tension'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}]",,0.0567074,The BCVA improved significantly in both groups (p = 0.013).,"[{'ForeName': 'Aditya', 'Initials': 'A', 'LastName': 'Sudhalkar', 'Affiliation': 'Raghudeep Eye Hospital and Ila Devi Cataract and IOL Research Centre, Ahmedabad, India. adityasudhalkar@yahoo.com.'}, {'ForeName': 'Abhay', 'Initials': 'A', 'LastName': 'Vasavada', 'Affiliation': 'Raghudeep Eye Hospital and Ila Devi Cataract and IOL Research Centre, Ahmedabad, India.'}, {'ForeName': 'Deepak', 'Initials': 'D', 'LastName': 'Bhojwani', 'Affiliation': 'Raghudeep Eye Hospital and Ila Devi Cataract and IOL Research Centre, Ahmedabad, India.'}, {'ForeName': 'Viraj', 'Initials': 'V', 'LastName': 'Vasavada', 'Affiliation': 'Raghudeep Eye Hospital and Ila Devi Cataract and IOL Research Centre, Ahmedabad, India.'}, {'ForeName': 'Shail', 'Initials': 'S', 'LastName': 'Vasavada', 'Affiliation': 'Raghudeep Eye Hospital and Ila Devi Cataract and IOL Research Centre, Ahmedabad, India.'}, {'ForeName': 'Vaishali', 'Initials': 'V', 'LastName': 'Vasavada', 'Affiliation': 'Raghudeep Eye Hospital and Ila Devi Cataract and IOL Research Centre, Ahmedabad, India.'}, {'ForeName': 'Samaresh', 'Initials': 'S', 'LastName': 'Srivastava', 'Affiliation': 'Raghudeep Eye Hospital and Ila Devi Cataract and IOL Research Centre, Ahmedabad, India.'}]","Eye (London, England)",['10.1038/s41433-019-0534-8'] 279,31320738,Relationship between duration and extent of oedema and visual acuity outcome with ranibizumab in diabetic macular oedema: A post hoc analysis of Protocol I data.,"BACKGROUND/OBJECTIVES This post hoc analysis explores the relationship between residual oedema exposure after ranibizumab treatment initiation and long-term visual acuity outcome in eyes with centre-involved diabetic macular oedema (DMO). SUBJECTS/METHODS Eyes randomised to the ranibizumab + prompt or deferred laser treatment arms in the Protocol I trial and with observed central retinal thickness (CRT) readings at baseline and ≥1 follow-up visits (n = 367) were stratified by 1) oedema duration (number of study visits with CRT ≥ 250 µm during the first 52 weeks of ranibizumab treatment); and 2) oedema extent (amount of excess CRT [≥ 250 µm] at each study visit, averaged over the first 52 weeks). Associations between measures of residual oedema and best-corrected visual acuity (BCVA) were assessed in multiple regression analyses. RESULTS Oedema duration and oedema extent during the first 52 weeks of ranibizumab treatment showed significant negative associations with BCVA improvement at weeks 52, 104 and 156. Eyes with the most persistent oedema gained (mean) 4.4 (95% CI 0.1─8.7) fewer Early Treatment Diabetic Retinopathy Study (ETDRS) letters at week 156 than eyes with the least persistent oedema (P = 0.044). Eyes with the greatest amount of oedema gained (mean) 9.3 (95% CI 4.0─14.5) fewer ETDRS letters at week 156 than eyes with the least amount of oedema (P < 0.001). CONCLUSIONS Macular oedema exposure over the first 52 weeks of ranibizumab treatment is a negative prognostic factor for long-term visual acuity improvement in centre-involved DMO.",2020,"Oedema duration and oedema extent during the first 52 weeks of ranibizumab treatment showed significant negative associations with BCVA improvement at weeks 52, 104 and 156.","['diabetic macular oedema', 'eyes with centre-involved diabetic macular oedema (DMO']","['ranibizumab + prompt or deferred laser treatment', 'ranibizumab']","['oedema and visual acuity outcome', 'residual oedema and best-corrected visual acuity (BCVA', 'Oedema duration and oedema extent', 'ETDRS letters']","[{'cui': 'C0730285', 'cui_str': 'Diabetic macular edema'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}]","[{'cui': 'C1566537', 'cui_str': 'ranibizumab'}, {'cui': 'C0023089', 'cui_str': 'Lasers'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0013604', 'cui_str': 'Hydrops'}, {'cui': 'C0042812', 'cui_str': 'Visual Acuity'}, {'cui': 'C1609982', 'cui_str': 'Residual (qualifier value)'}, {'cui': 'C1690532', 'cui_str': 'Best corrected visual acuity'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0439792', 'cui_str': 'Extents (qualifier value)'}, {'cui': 'C1096774', 'cui_str': 'Letter'}]",367.0,0.11728,"Oedema duration and oedema extent during the first 52 weeks of ranibizumab treatment showed significant negative associations with BCVA improvement at weeks 52, 104 and 156.","[{'ForeName': 'Srinivas R', 'Initials': 'SR', 'LastName': 'Sadda', 'Affiliation': 'Doheny Eye Institute, Los Angeles, CA, USA. SSadda@doheny.org.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Campbell', 'Affiliation': 'Allergan plc, Irvine, CA, USA.'}, {'ForeName': 'Pravin U', 'Initials': 'PU', 'LastName': 'Dugel', 'Affiliation': 'Retinal Consultants of Arizona, Phoenix, AZ, USA.'}, {'ForeName': 'Nancy M', 'Initials': 'NM', 'LastName': 'Holekamp', 'Affiliation': 'Pepose Vision Institute and Washington University School of Medicine, St. Louis, MO, USA.'}, {'ForeName': 'Szilárd', 'Initials': 'S', 'LastName': 'Kiss', 'Affiliation': 'Weill Cornell Medical College, New York, NY, USA.'}, {'ForeName': 'Anat', 'Initials': 'A', 'LastName': 'Loewenstein', 'Affiliation': 'Department of Ophthalmology, Tel Aviv Medical Center and Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Albert J', 'Initials': 'AJ', 'LastName': 'Augustin', 'Affiliation': 'Department of Ophthalmology, Staedtisches Klinikum Karlsruhe, Karlsruhe, Germany.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Shih', 'Affiliation': 'Allergan plc, Irvine, CA, USA.'}, {'ForeName': 'Xiaoshu', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': 'Allergan plc, Irvine, CA, USA.'}, {'ForeName': 'Charles C', 'Initials': 'CC', 'LastName': 'Wykoff', 'Affiliation': 'Retina Consultants of Houston, Blanton Eye Institute, Houston Methodist Hospital, Houston, TX, USA.'}, {'ForeName': 'Scott M', 'Initials': 'SM', 'LastName': 'Whitcup', 'Affiliation': 'Jules Stein Eye Institute, David Geffen School of Medicine at UCLA, Los Angeles, CA, USA.'}]","Eye (London, England)",['10.1038/s41433-019-0522-z'] 280,32296925,Anterior or posterior SWL in proximal ureteral stones opposite to 4th and 5th lumbar vertebrae?,"BACKGROUND Results of SWL in treatment of upper ureteral calculi are conflicting which is definitely affected by stone locations along the proximal ureter, which is may be due to the more deep and medial course of the ureter distally over the thick and strong abdominal back wall which may hinder shock waves. METHODOLOGY One hundred patients with radiopaque proximal ureteral stone opposite 4th and 5th lumbar vertebrae who had SWL were randomized into two groups. First group had SWL through anterior belly wall in supine position with countertraction, the second group had standard posterior SWL. Patient's demographics and stone characters were evaluated assessing stone burden and calculating S.T.O.N.E score. Patients were followed up to assess stone-free rate using serial digital plain X-ray KUB. RESULTS Anterior approach needed less power to reach SFR (p = 0.05) in less number of sessions where 90% of cases in anterior group had only one session to reach SFR versus 52% in posterior group (p = 0.001). Also, post-SWL pain, hematuria, obstruction and infection were significantly less in anterior group (p = 0.005). Although patients who had anterior approach showed statistically significant shorter time to stone expulsion. SFR does not differed significantly between study groups (p = 0.02). On further analysis; anterior SWL had a better chance to reach SFR (HR = 1.6, p = 0.001). CONCLUSION It seems that anterior SWL approach in supine position is safe and effective especially in mild obese patient with floppy abdomen. Patients who had anterior SWL approach had a better chance to achieve stone-free rate.",2020,"RESULTS Anterior approach needed less power to reach SFR (p = 0.05) in less number of sessions where 90% of cases in anterior group had only one session to reach SFR versus 52% in posterior group (p = 0.001).","['One hundred patients with radiopaque proximal ureteral stone opposite 4th and 5th lumbar vertebrae who had SWL', 'mild obese patient with floppy abdomen']","['SWL', 'Anterior or posterior SWL']","['power to reach SFR', 'post-SWL pain, hematuria, obstruction and infection', 'time to stone expulsion', 'SFR', 'stone-free rate']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0041952', 'cui_str': 'Ureteric stone'}, {'cui': 'C0205438', 'cui_str': 'Fourth'}, {'cui': 'C0205439', 'cui_str': 'Fifth'}, {'cui': 'C0024091', 'cui_str': 'Bone structure of lumbar vertebra'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0857516', 'cui_str': 'Floppy'}, {'cui': 'C0607422', 'cui_str': 'Abdoman (drug)'}]","[{'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}]","[{'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C1264665', 'cui_str': 'Substance fraction'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0018965', 'cui_str': 'Blood in urine'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0006736', 'cui_str': 'Calculus'}, {'cui': 'C1293107', 'cui_str': 'Expulsion'}, {'cui': 'C0332296', 'cui_str': 'Free of'}]",100.0,0.0291843,"RESULTS Anterior approach needed less power to reach SFR (p = 0.05) in less number of sessions where 90% of cases in anterior group had only one session to reach SFR versus 52% in posterior group (p = 0.001).","[{'ForeName': 'Tarek Khalaf', 'Initials': 'TK', 'LastName': 'Fathelbab', 'Affiliation': 'Urology Department, Minia Urology & Nephrology University Hospital, School of Medicine, Minia University, Minia, Egypt.'}, {'ForeName': 'Mohammed G S', 'Initials': 'MGS', 'LastName': 'Hasanein', 'Affiliation': 'Specialized SWL Center, Nile SWL, Minia, Egypt.'}, {'ForeName': 'Ahmed M', 'Initials': 'AM', 'LastName': 'Fawzy', 'Affiliation': 'Urology Department, Minia Urology & Nephrology University Hospital, School of Medicine, Minia University, Minia, Egypt. ahmed.fawzi@mu.edu.eg.'}]",World journal of urology,['10.1007/s00345-020-03174-3'] 281,31617335,Effects of ketamine on circadian rhythm and synaptic homeostasis in patients with treatment-resistant depression: A protocol for mechanistic studies of its rapid and sustained antidepressant actions in humans.,"BACKGROUND The breakthrough discovery has been made that a single dose of ketamine, an N-methyl-D-aspartate receptor antagonist, achieves rapid and sustained (~7 days) antidepressant activity in patients with major depressive disorder (MDD). This discovery has ushered in an exciting era of research and brought new hope for patients with MDD. However, the mechanisms underlying the specific antidepressant actions of ketamine in humans remain to be elucidated. OBJECTIVES This study protocol was designed to test the main hypothesis that ketamine could rapidly reverse depression- and stress-associated synaptic loss and deficits in resting-state functional connectivity and that this action could be affected by circadian rhythm, in patients with treatment-resistant depression. METHODS/STUDY DESIGN In this clinical study, adults (aged 18-65 years) with treatment-resistant depression will be randomized to intravenous administration of placebo (control group) or ketamine (0.5 mg/kg body weight) at 11 a.m. (daytime group), or 6 p.m. (nighttime group) for 24 weeks. The primary outcome will be the change from baseline to 24 weeks in the total Montgomery-Asberg Depression Rating Scale score. Brain imaging, sleep, and genetic studies, including functional magnetic resonance imaging, positron emission tomography, polysomnography, and genetic analyses, will be performed to examine whether and how ketamine can rapidly reverse deficits in synaptic function and to identify objective markers for the assessment of ketamine infusion therapy for treatment-resistant depression. CONCLUSIONS This clinical study protocol is the first, to our knowledge, to describe the prospective testing of the hypothesis that daytime and nighttime administrations of ketamine would have different antidepressant effects. The brain imaging, sleep, and genetic findings from patients with treatment-resistant depression are expected to shed new light on the mechanisms of ketamine and its interaction with target sites in the brain, which can be used for objective evaluation of the efficacy of ketamine.",2019,"This study protocol was designed to test the main hypothesis that ketamine could rapidly reverse depression- and stress-associated synaptic loss and deficits in resting-state functional connectivity and that this action could be affected by circadian rhythm, in patients with treatment-resistant depression. ","['patients with treatment-resistant depression', 'patients with major depressive disorder (MDD', 'adults (aged 18-65\xa0years) with treatment-resistant depression', 'humans', 'patients with MDD']","['placebo (control group) or ketamine', 'ketamine']","['total Montgomery-Asberg Depression Rating Scale score', 'circadian rhythm and synaptic homeostasis']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2063866', 'cui_str': 'Refractory Depression'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4706358', 'cui_str': 'MADRS (Montgomery-Asberg Depression Rating Scale) score'}, {'cui': 'C0008810', 'cui_str': 'Nycthemeral Rhythm'}, {'cui': 'C0019868', 'cui_str': 'Autoregulation'}]",,0.0385002,"This study protocol was designed to test the main hypothesis that ketamine could rapidly reverse depression- and stress-associated synaptic loss and deficits in resting-state functional connectivity and that this action could be affected by circadian rhythm, in patients with treatment-resistant depression. ","[{'ForeName': 'Chuanjun', 'Initials': 'C', 'LastName': 'Zhuo', 'Affiliation': 'School of Mental Health, Jining Medical University, Jining, China.'}, {'ForeName': 'Hongjun', 'Initials': 'H', 'LastName': 'Tian', 'Affiliation': 'Psychiatric-Neuroimaging-Genetics-Comorbidity Laboratory (PNGC_Lab), Tianjin Mental Health Centre, Mental Health Teaching Hospital of Tianjin Medical University, Tianjin Anding Hospital, Tianjin, China.'}, {'ForeName': 'Gongying', 'Initials': 'G', 'LastName': 'Li', 'Affiliation': 'School of Mental Health, Jining Medical University, Jining, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Chen', 'Affiliation': 'School of Mental Health, Jining Medical University, Jining, China.'}, {'ForeName': 'Deguo', 'Initials': 'D', 'LastName': 'Jiang', 'Affiliation': ""Psychiatric-Neuroimaging-Genetics Laboratory, Wenzhou Seventh People's Hospital, Wenzhou, China.""}, {'ForeName': 'Xiaodong', 'Initials': 'X', 'LastName': 'Lin', 'Affiliation': ""Psychiatric-Neuroimaging-Genetics Laboratory, Wenzhou Seventh People's Hospital, Wenzhou, China.""}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Xu', 'Affiliation': 'Department of Psychiatry, First Hospital/First Clinical Medical College of Shanxi Medical University, Taiyuan, China.'}, {'ForeName': 'Wenqiang', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'Co-collaboration Laboratory of China and Canada, Xiamen Xianyue Hospital and University of Alberta, Xiamen, China.'}]",Brain and behavior,['10.1002/brb3.1423'] 282,31305011,"Efficacy, immunogenicity and safety of the AS04-HPV-16/18 vaccine in Chinese women aged 18-25 years: End-of-study results from a phase II/III, randomised, controlled trial.","BACKGROUND Cervical cancer is a major public health concern in China. We report the end-of-study results of a phase II/III trial to assess the efficacy, immunogenicity, and safety of the AS04-human papillomavirus (HPV)-16/18 vaccine in Chinese women aged 18-25 years followed for up to 72 months after first vaccination. Results of approximately 57 months following first vaccination have been previously reported. METHODS Healthy 18-25-year-old women (N = 6051) were randomized (1:1) to receive three doses of AS04-HPV-16/18 vaccine or Al(OH) 3 (control) at Months 0-1-6. Vaccine efficacy against HPV-16/18 infection and cervical intraepithelial neoplasia (CIN), cross-protective vaccine efficacy against infections and lesions associated with nonvaccine oncogenic HPV types, immunogenicity, and safety were assessed. Efficacy was assessed in the according-to-protocol efficacy (ATP-E) cohort (vaccine N = 2888; control N = 2892), total vaccinated cohort for efficacy (TVC-E; vaccine N = 2987; control N = 2985) and TVC-naïve (vaccine N = 1660; control N = 1587). RESULTS In initially HPV-16/18 seronegative/DNA-negative women, vaccine efficacy against HPV-16/18-associated CIN grade 2 or worse was 87.3% (95% CI: 5.5, 99.7) in the ATP-E, 88.7% (95% CI: 18.5, 99.7) in the TVC-E, and 100% (95% CI: 17.9, 100) in the TVC-naïve. Cross-protective efficacy against incident infection with HPV-31, HPV-33 and HPV-45 was 59.6% (95% CI: 39.4, 73.5), 42.7% (95% CI: 15.6, 61.6), and 54.8% (95% CI: 19.3, 75.6), respectively (ATP-E). At Month 72, >95% of initially seronegative women who received HPV vaccine in the ATP cohort for immunogenicity (N = 664) remained seropositive for anti-HPV-16/18 antibodies; anti-HPV-16 and anti-HPV-18 geometric mean titers were 678.1 EU/mL (95% CI: 552.9, 831.5) and 343.7 EU/mL (95% CI: 291.9, 404.8), respectively. Serious adverse events were infrequent (1.9% vaccine group [N = 3026]; 2.7% control group [N = 3025]). Three and zero women died in the control group and the vaccine group respectively. New onset autoimmune disease was reported in two women in the vaccine group and two in the control group. CONCLUSIONS This is the first large-scale randomized clinical trial of HPV vaccination in China. High and sustained vaccine efficacy against HPV-16/18-associated infection and cervical lesions was demonstrated up to Month 72. The vaccine had an acceptable safety profile. Combined with screening, prophylactic HPV vaccination could potentially reduce the high burden of HPV infection and cervical cancer in China. TRIAL REGISTRATION NCT00779766.",2019,High and sustained vaccine efficacy against HPV-16/18-associated infection and cervical lesions was demonstrated up to Month 72.,"['Chinese women aged 18-25\xa0years', 'Healthy 18-25-year-old women (N\xa0=\xa06051', 'Chinese women aged 18-25\xa0years followed for up to 72\xa0months after first vaccination']","['prophylactic HPV vaccination', 'total vaccinated cohort for efficacy (TVC-E; vaccine N\xa0=\xa02987; control N\xa0=\xa02985) and TVC-naïve (vaccine N\xa0=\xa01660; control N\xa0=\xa01587', 'AS04-human papillomavirus (HPV)-16/18 vaccine', 'AS04-HPV-16/18 vaccine', 'HPV vaccine', 'AS04-HPV-16/18 vaccine or Al(OH) 3 (control) at Months 0-1-6']","['Efficacy, immunogenicity and safety', 'New onset autoimmune disease', 'efficacy, immunogenicity, and safety', 'Vaccine efficacy against HPV-16/18 infection and cervical intraepithelial neoplasia (CIN', 'Serious adverse events', 'high burden of HPV infection and cervical cancer', 'Efficacy']","[{'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]","[{'cui': 'C0445202', 'cui_str': 'Prophylactic (qualifier value)'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C1512511', 'cui_str': 'HPV Vaccines'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0004364', 'cui_str': 'Autoimmune Diseases'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0206708', 'cui_str': 'Cervical Intraepithelial Neoplasms'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0343641', 'cui_str': 'HPV Infection'}, {'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix (disorder)'}]",,0.449819,High and sustained vaccine efficacy against HPV-16/18-associated infection and cervical lesions was demonstrated up to Month 72.,"[{'ForeName': 'Feng-Cai', 'Initials': 'FC', 'LastName': 'Zhu', 'Affiliation': 'Jiangsu Province Center for Disease Prevention and Control, Nanjing, China.'}, {'ForeName': 'Shang-Ying', 'Initials': 'SY', 'LastName': 'Hu', 'Affiliation': 'National Cancer Center - Cancer Hospital, Chinese Academy of Medical Sciences (CAMS) & Peking Union Medical College (PUMC), Beijing, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Hong', 'Affiliation': 'Affiliated Drum Tower Hospital of Nanjing University Medical School, Nanjing, China.'}, {'ForeName': 'Yue-Mei', 'Initials': 'YM', 'LastName': 'Hu', 'Affiliation': 'Jiangsu Province Center for Disease Prevention and Control, Nanjing, China.'}, {'ForeName': 'Xun', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'National Cancer Center - Cancer Hospital, Chinese Academy of Medical Sciences (CAMS) & Peking Union Medical College (PUMC), Beijing, China.'}, {'ForeName': 'Yi-Ju', 'Initials': 'YJ', 'LastName': 'Zhang', 'Affiliation': 'Jiangsu Province Center for Disease Prevention and Control, Nanjing, China.'}, {'ForeName': 'Qin-Jing', 'Initials': 'QJ', 'LastName': 'Pan', 'Affiliation': 'National Cancer Center - Cancer Hospital, Chinese Academy of Medical Sciences (CAMS) & Peking Union Medical College (PUMC), Beijing, China.'}, {'ForeName': 'Wen-Hua', 'Initials': 'WH', 'LastName': 'Zhang', 'Affiliation': 'National Cancer Center - Cancer Hospital, Chinese Academy of Medical Sciences (CAMS) & Peking Union Medical College (PUMC), Beijing, China.'}, {'ForeName': 'Fang-Hui', 'Initials': 'FH', 'LastName': 'Zhao', 'Affiliation': 'National Cancer Center - Cancer Hospital, Chinese Academy of Medical Sciences (CAMS) & Peking Union Medical College (PUMC), Beijing, China.'}, {'ForeName': 'Cheng-Fu', 'Initials': 'CF', 'LastName': 'Zhang', 'Affiliation': 'Lianshui Center for Disease Prevention and Control, Lianshui, China.'}, {'ForeName': 'Xiaoping', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': 'Jintan Center for Disease Prevention and Control, Jintan, China.'}, {'ForeName': 'Jia-Xi', 'Initials': 'JX', 'LastName': 'Yu', 'Affiliation': 'Xuzhou Center for Disease Prevention and Control, Xuzhou, China.'}, {'ForeName': 'Jiahong', 'Initials': 'J', 'LastName': 'Zhu', 'Affiliation': 'Lianshui Center for Disease Prevention and Control, Lianshui, China.'}, {'ForeName': 'Yejiang', 'Initials': 'Y', 'LastName': 'Zhu', 'Affiliation': 'Binhai Center for Disease Prevention and Control, Yancheng, China.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Chen', 'Affiliation': 'National Cancer Center - Cancer Hospital, Chinese Academy of Medical Sciences (CAMS) & Peking Union Medical College (PUMC), Beijing, China.'}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': 'National Cancer Center - Cancer Hospital, Chinese Academy of Medical Sciences (CAMS) & Peking Union Medical College (PUMC), Beijing, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'National Cancer Center - Cancer Hospital, Chinese Academy of Medical Sciences (CAMS) & Peking Union Medical College (PUMC), Beijing, China.'}, {'ForeName': 'Changrong', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'Jintan Center for Disease Prevention and Control, Jintan, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Bi', 'Affiliation': 'Xuzhou Center for Disease Prevention and Control, Xuzhou, China.'}, {'ForeName': 'Shiyin', 'Initials': 'S', 'LastName': 'Xue', 'Affiliation': 'Lianshui Center for Disease Prevention and Control, Lianshui, China.'}, {'ForeName': 'Lingling', 'Initials': 'L', 'LastName': 'Shen', 'Affiliation': 'Xuzhou Center for Disease Prevention and Control, Xuzhou, China.'}, {'ForeName': 'Yan-Shu', 'Initials': 'YS', 'LastName': 'Zhang', 'Affiliation': 'Binhai Center for Disease Prevention and Control, Yancheng, China.'}, {'ForeName': 'Yunkun', 'Initials': 'Y', 'LastName': 'He', 'Affiliation': 'GSK, Shanghai, China.'}, {'ForeName': 'Haiwen', 'Initials': 'H', 'LastName': 'Tang', 'Affiliation': 'GSK, Shanghai, China.'}, {'ForeName': 'Naveen', 'Initials': 'N', 'LastName': 'Karkada', 'Affiliation': 'GSK, Bangalore, India.'}, {'ForeName': 'Pemmaraju', 'Initials': 'P', 'LastName': 'Suryakiran', 'Affiliation': 'GSK, Bangalore, India.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Bi', 'Affiliation': 'GSK, Wavre, Belgium.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Struyf', 'Affiliation': 'GSK, Wavre, Belgium.'}]",Cancer medicine,['10.1002/cam4.2399'] 283,32149773,Effectiveness of glucocorticoid therapy in patients with severe coronavirus disease 2019: protocol of a randomized controlled trial.,"BACKGROUND At the end of 2019, a novel coronavirus outbreak causative organism has been subsequently designated the 2019 novel coronavirus (2019-nCoV). The effectiveness of adjunctive glucocorticoid therapy in the management of 2019-nCoV-infected patients with severe lower respiratory tract infections is not clear, and warrants further investigation. METHODS The present study will be conducted as an open-labeled, randomized, controlled trial. We will enrol 48 subjects from Chongqing Public Health Medical Center. Each eligible subject will be assigned to an intervention group (methylprednisolone via intravenous injection at a dose of 1-2 mg/kg/day for 3 days) or a control group (no glucocorticoid use) randomly, at a 1:1 ratio. Subjects in both groups will be invited for 28 days of follow-up which will be scheduled at four consecutive visit points. We will use the clinical improvement rate as our primary endpoint. Secondary endpoints include the timing of clinical improvement after intervention, duration of mechanical ventilation, duration of hospitalization, overall incidence of adverse events, as well as rate of adverse events at each visit, and mortality at 2 and 4 weeks. DISCUSSION The present coronavirus outbreak is the third serious global coronavirus outbreak in the past two decades. Oral and parenteral glucocorticoids have been used in the management of severe respiratory symptoms in coronavirus-infected patients in the past. However, there remains no definitive evidence in the literature for or against the utilization of systemic glucocorticoids in seriously ill patients with coronavirus-related severe respiratory disease, or indeed in other types of severe respiratory disease. In this study, we hope to discover evidence either supporting or opposing the systemic therapeutic administration of glucocorticoids in patients with severe coronavirus disease 2019. TRIAL REGISTRATION ClinicalTrials.gov, ChiCTR2000029386, http://www.chictr.org.cn/showproj.aspx?proj=48777.",2020,Oral and parenteral glucocorticoids have been used in the management of severe respiratory symptoms in coronavirus-infected patients in the past.,"['48 subjects from Chongqing Public Health Medical Center', 'Patients who become infected with 2019-nCoV may initially develop mild upper respiratory tract symptoms', '2019-nCoV infected patients with severe lower respiratory tract infections', 'patients with severe novel coronavirus pneumonia', 'severe coronavirus disease 2019 (COVID-19) patients', 'seriously ill patients with coronavirus-related severe respiratory disease']","['adjunctive glucocorticoid therapy', 'glucocorticoid therapy', 'glucocorticoids', 'Oral and parenteral glucocorticoids', 'intervention group (methylprednisolone', 'control group (no glucocorticoid']","['timing of clinical improvement after intervention, duration of mechanical ventilation, duration of hospitalization, overall incidence of adverse events, as well as rate of adverse events at each visit, and mortality at 2 and 4 weeks']","[{'cui': 'C0034019', 'cui_str': 'Community Health'}, {'cui': 'C0565990', 'cui_str': 'Medical center (environment)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'TS-COV19'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0458578', 'cui_str': 'Upper respiratory tract structure'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0035243', 'cui_str': 'Infections, Respiratory'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0035204', 'cui_str': 'Respiration Disorders'}]","[{'cui': 'C0744425', 'cui_str': 'Glucocorticoid therapy'}, {'cui': 'C3540778', 'cui_str': 'Glucocorticoids'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C4522267', 'cui_str': 'Parenteral (intended site)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0025815', 'cui_str': 'Methylprednisolone'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0449243', 'cui_str': 'Timing (attribute)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0199470', 'cui_str': 'Mechanically assisted ventilation'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]",48.0,0.138429,Oral and parenteral glucocorticoids have been used in the management of severe respiratory symptoms in coronavirus-infected patients in the past.,"[{'ForeName': 'Yuan-Yuan', 'Initials': 'YY', 'LastName': 'Qin', 'Affiliation': 'Division of Infectious Diseases, Chongqing Public Health Medical Center, Chongqing 400036, China.'}, {'ForeName': 'Yi-Hong', 'Initials': 'YH', 'LastName': 'Zhou', 'Affiliation': ''}, {'ForeName': 'Yan-Qiu', 'Initials': 'YQ', 'LastName': 'Lu', 'Affiliation': ''}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Sun', 'Affiliation': ''}, {'ForeName': 'Sen', 'Initials': 'S', 'LastName': 'Yang', 'Affiliation': ''}, {'ForeName': 'Vijay', 'Initials': 'V', 'LastName': 'Harypursat', 'Affiliation': ''}, {'ForeName': 'Yao-Kai', 'Initials': 'YK', 'LastName': 'Chen', 'Affiliation': ''}]",Chinese medical journal,['10.1097/CM9.0000000000000791'] 284,31663683,Worse characteristics can predict survival effectively in bilateral primary breast cancer: A competing risk nomogram using the SEER database.,"OBJECTIVE There is limited information from population-based cancer registries regarding prognostic features of bilateral primary breast cancer (BPBC). METHODS Female patients diagnosed with BPBC between 2004 and 2014 were randomly divided into training (n = 7740) and validation (n = 2579) cohorts from the Surveillance, Epidemiology, and End Results Database. We proposed five various models. Multivariate Cox hazard regression and competing risk analysis were to explore prognosis factors in training cohort. Competing risk nomograms were constructed to combine significant prognostic factors to predict the 3-year and the 5-year survival of patients with BPBC. At last, in the validation cohort, the new score performance was evaluated with respect to the area under curve, concordance index, net reclassification index and calibration curve. RESULTS We found out that age, interval time, lymph nodes invasion, tumor size, tumor grade and estrogen receptor status were independent prognostic factors in both multivariate Cox hazard regression analysis and competing risk analysis. Concordance index in the model of the worse characteristics was 0.816 (95% CI: 0.791-0.840), of the bilateral tumors was 0.819 (95% CI: 0.793-0.844), of the worse tumor was 0.807 (0.782-0.832), of the first tumor was 0.744 (0.728-0.763) and of the second tumor was 0.778 (0.762-0.794). Net reclassification index of the 3-year and the 5-year between them was 2.7% and -1.0%. The calibration curves showed high concordance between the nomogram prediction and actual observation. CONCLUSION The prognosis of BPBC depended on bilateral tumors. The competing risk nomogram of the model of the worse characteristics may help clinicians predict survival simply and effectively. Metachronous bilateral breast cancer presented poorer survival than synchronous bilateral breast cancer.",2019,Concordance index in the model of the worse characteristics was 0.816,"['bilateral primary breast cancer', 'Female patients diagnosed with BPBC between 2004 and 2014']",[],"['interval time, lymph nodes invasion, tumor size, tumor grade and estrogen receptor status', 'Concordance index', '5-year survival']","[{'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]",[],"[{'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0024204', 'cui_str': 'Lymphatic gland'}, {'cui': 'C0475440', 'cui_str': 'Tumor size'}, {'cui': 'C3179006', 'cui_str': 'Tumor Grading'}, {'cui': 'C0034804', 'cui_str': 'Estrogen Receptors'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",2014.0,0.0417756,Concordance index in the model of the worse characteristics was 0.816,"[{'ForeName': 'Kaiwen', 'Initials': 'K', 'LastName': 'Shen', 'Affiliation': 'Yangzhou University Medical Academy, Yangzhou, Jiangsu, China.'}, {'ForeName': 'Longdi', 'Initials': 'L', 'LastName': 'Yao', 'Affiliation': 'The Second Clinical College of Dalian Medical University, Dalian, Liaoning, China.'}, {'ForeName': 'Jinli', 'Initials': 'J', 'LastName': 'Wei', 'Affiliation': ""Department of Thyroid and Breast Surgery, Yangzhou University Affiliated Northern Jiangsu People's Hospital, Yangzhou, Jiangsu, China.""}, {'ForeName': 'Zhou', 'Initials': 'Z', 'LastName': 'Luo', 'Affiliation': ""Department of Thyroid and Breast Surgery, Yangzhou University Affiliated Northern Jiangsu People's Hospital, Yangzhou, Jiangsu, China.""}, {'ForeName': 'Wang', 'Initials': 'W', 'LastName': 'Yu', 'Affiliation': 'Department of Thyroid and Breast Surgery, The Second Xiangya Hospital of Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Huamin', 'Initials': 'H', 'LastName': 'Zhai', 'Affiliation': 'Yangzhou University Medical Academy, Yangzhou, Jiangsu, China.'}, {'ForeName': 'Jianwen', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Yangzhou University Medical Academy, Yangzhou, Jiangsu, China.'}, {'ForeName': 'Luhong', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Yangzhou University Medical Academy, Yangzhou, Jiangsu, China.'}, {'ForeName': 'Deyuan', 'Initials': 'D', 'LastName': 'Fu', 'Affiliation': 'Yangzhou University Medical Academy, Yangzhou, Jiangsu, China.'}]",Cancer medicine,['10.1002/cam4.2662'] 285,31663690,Effects of serum from breast cancer surgery patients receiving perioperative dexmedetomidine on breast cancer cell malignancy: A prospective randomized controlled trial.,"Adrenergic receptors (ARs) have gained attention for their involvement in breast cancer (BC) progression. Dexmedetomidine, a selective α 2 -AR agonist, has been reported to increase the malignancy of BC cells in vitro or stimulate tumor growth in mice. However, clinical evidence is lacking. Clinical research in this area is important as dexmedetomidine is widely used in BC surgery patients. Here we allocated 24 women with primary BC to the dexmedetomidine group (who received a total dose of 2 μg kg -1 dexmedetomidine perioperatively) or to the control group (who received the same volume of normal saline). Venous blood was obtained from all patients immediately upon entering the operating room and 24 hours postoperatively. Serum was then exposed to MCF-7 cells at a concentration of 10% for 24 hours. Cell proliferation, migration, and invasion were analyzed using EdU, Transwell, and Matrigel methods, respectively. We found that postoperative serum from those who received dexmedetomidine was associated with significantly increased cell proliferation, migration, and invasion compared with preoperative serum when used to culture MCF-7 cells. The mean percentage change from post to preoperative values in these cell functions was significantly larger in the dexmedetomidine group than in the control group (proliferation, 30.44% vs 8.45%, P = .0024; migration, 15.90% vs 3.25%, P = .0015; invasion, 8.17% vs 2.13%, P = .04). In conclusion, these findings suggest that in patients undergoing surgery for primary BC, perioperative administration of dexmedetomidine might influence the serum milieu in a way that favors the malignancy of MCF-7 cells. Clinical trial registration: NCT03108937.",2019,"We found that postoperative serum from those who received dexmedetomidine was associated with significantly increased cell proliferation, migration, and invasion compared with preoperative serum when used to culture MCF-7 cells.","['breast cancer surgery patients receiving', '24 women with primary BC to the', 'BC surgery patients', 'breast cancer cell malignancy', 'patients undergoing surgery for primary BC']","['dexmedetomidine', 'total dose of 2\xa0μg\xa0kg -1 dexmedetomidine perioperatively) or to the control group (who received the same volume of normal saline', 'Dexmedetomidine', 'perioperative dexmedetomidine', 'Adrenergic receptors (ARs']","['cell proliferation, migration, and invasion', 'Venous blood', 'Cell proliferation, migration, and invasion']","[{'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}]","[{'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C0034783', 'cui_str': 'Adrenoceptors'}]","[{'cui': 'C0596290', 'cui_str': 'Cell Proliferation'}, {'cui': 'C1533574', 'cui_str': 'Migration, function (observable entity)'}, {'cui': 'C0229667', 'cui_str': 'VB - Venous blood'}]",24.0,0.0717347,"We found that postoperative serum from those who received dexmedetomidine was associated with significantly increased cell proliferation, migration, and invasion compared with preoperative serum when used to culture MCF-7 cells.","[{'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Anesthesiology, Renji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Jiaxin', 'Initials': 'J', 'LastName': 'Sun', 'Affiliation': 'Department of Anesthesiology, Renji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Tong', 'Initials': 'T', 'LastName': 'Wu', 'Affiliation': 'Department of Anesthesiology, Renji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Xiaoying', 'Initials': 'X', 'LastName': 'Lu', 'Affiliation': 'Department of Anesthesiology, Shanghai Pudong Hospital, Fudan University Pudong Medical Center, Shanghai, China.'}, {'ForeName': 'Yueyao', 'Initials': 'Y', 'LastName': 'Du', 'Affiliation': 'Department of Breast, Renji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Hongwei', 'Initials': 'H', 'LastName': 'Duan', 'Affiliation': 'Department of Anesthesiology, Shanghai Pudong Hospital, Fudan University Pudong Medical Center, Shanghai, China.'}, {'ForeName': 'Weifeng', 'Initials': 'W', 'LastName': 'Yu', 'Affiliation': 'Department of Anesthesiology, Renji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Diansan', 'Initials': 'D', 'LastName': 'Su', 'Affiliation': 'Department of Anesthesiology, Renji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Jinsong', 'Initials': 'J', 'LastName': 'Lu', 'Affiliation': 'Department of Breast, Renji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Tian', 'Affiliation': 'Department of Anesthesiology, Renji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}]",Cancer medicine,['10.1002/cam4.2654'] 286,31697242,Electronic Screening for Alcohol Use and Brief Intervention by Email for University Students: Reanalysis of Findings From a Randomized Controlled Trial Using a Bayesian Framework.,"BACKGROUND Almost a decade ago, Sweden became the first country to implement a national system enabling student health care centers across all universities to routinely administer (via email) an electronic alcohol screening and brief intervention to their students. The Alcohol email assessment and feedback study dismantling effectiveness for university students (AMADEUS-1) trial aimed to assess the effect of the student health care centers' routine practices by exploiting the lack of any standard timing for the email invitation and by masking trial participation from students. The original analyses adopted the conventional null hypothesis framework, and the results were consistently in the expected direction. However, since for some tests the P values did not pass the conventional .05 threshold, some of the analyses were necessarily inconclusive. OBJECTIVE The outcomes of the AMADEUS-1 trial were derived from the first 3 items of the Alcohol Use Disorders Identification Test (AUDIT-C). The aim of this paper was to reanalyze the two primary outcomes of the AMADEUS-1 trial (AUDIT-C scores and prevalence of risky drinking), using the same models used in the original publication but applying a Bayesian inference framework and interpretation. METHODS The same regression models used in the original analysis were employed in this reanalysis (linear and logistic regression). Model parameters were given uniform priors. Markov chain Monte Carlo was used for Bayesian inference, and posterior probabilities were calculated for prespecified thresholds of interest. RESULTS Where the null hypothesis tests showed inconclusive results, the Bayesian analysis showed that offering an intervention at baseline was preferable compared to offering nothing. At follow-up, the probability of a lower AUDIT-C score among those who had been offered an intervention at baseline was greater than 95%, as was the case when comparing the prevalence of risky drinking. CONCLUSIONS The Bayesian analysis allows for a more consistent perspective of the data collected in the trial, since dichotomization of evidence is not looked for at some arbitrary threshold. Results are presented that represent the data collected in the trial rather than trying to make conclusions about the existence of a population effect. Thus, policy makers can think about the value of keeping the national system without having to navigate the treacherous landscape of statistical significance. TRIAL REGISTRATION ISRCTN Registry ISRCTN28328154; http://www.isrctn.com/ISRCTN28328154.",2019,"At follow-up, the probability of a lower AUDIT-C score among those who had been offered an intervention at baseline was greater than 95%, as was the case when comparing the prevalence of risky drinking. ","['for University Students', 'university students']",['Electronic Screening for Alcohol Use and Brief Intervention by Email'],['probability of a lower AUDIT-C score'],"[{'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}]","[{'cui': 'C4281784', 'cui_str': 'Electronics'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0013849', 'cui_str': 'Email'}]","[{'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.0519014,"At follow-up, the probability of a lower AUDIT-C score among those who had been offered an intervention at baseline was greater than 95%, as was the case when comparing the prevalence of risky drinking. ","[{'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Bendtsen', 'Affiliation': 'Department of Medical and Health Sciences, Linköping University, Linköping, Sweden.'}]",Journal of medical Internet research,['10.2196/14419'] 287,31335588,Short- and Long-Term Pharmacologic Measures of HIV Pre-exposure Prophylaxis Use Among High-Risk Men Who Have Sex With Men in HPTN 067/ADAPT.,"BACKGROUND The effectiveness of oral emtricitabine (FTC)/tenofovir (TFV) disoproxil fumarate-based HIV pre-exposure prophylaxis (PrEP) depends on adherence. Pharmacologic measures help interpret patterns and predictors of PrEP adherence. SETTING We analyzed data from the subsample of men who have sex with men enrolled in HPTN 067/ADAPT in Bangkok, Thailand, and Harlem, NY, U.S. METHODS After a 5-week directly observed therapy period, participants were randomized to daily, time-driven, or event-driven PrEP. Follow-up occurred at weeks 4, 12, and 24 after randomization. Plasma and hair FTC/TFV levels indicated short- and long-term PrEP use, respectively. Electronic pill bottle data (Wisepill) were collected weekly. Pearson correlation coefficients between PrEP use measures were calculated; linear mixed models assessed predictors of plasma and hair drug concentrations. RESULTS Among 350 participants (median age: 31 years, interquartile range: 25-38), 49.7% were from Harlem, half had less than college education, and 21% reported heavy alcohol use. In multivariable models, being enrolled in Harlem, being in non-daily arms, and having less than college education were associated with lower hair FTC/TFV concentrations; heavy alcohol use was associated with higher concentrations. Similar results were found for plasma concentrations by site and arm, but older age and greater number of sex partners were associated with higher concentrations. Hair and plasma FTC/TFV concentrations were moderately correlated with Wisepill data (r ≥ 0.29) across visits. CONCLUSIONS In HPTN067, plasma, hair, and Wisepill data correlated with one another and served as complementary adherence measures. Site, arm, education, age, alcohol, and sexual behavior influenced patterns of adherence.",2019,"Similar results were found for plasma concentrations by site and arm, but older age and greater number of sex partners were associated with higher concentrations.","['high-risk men who have sex with men in HPTN 067/ADAPT', 'sub-sample of men who have sex with men (MSM) enrolled in HPTN 067/ADAPT in Bangkok, Thailand, and Harlem, NY, U.S.\nMETHODS', '350 participants (median age 31 years, interquartile range [IQR]: 25-38), 49.7% were from Harlem, half had less than college education, and 21% reported heavy alcohol use']","['oral emtricitabine (FTC)/tenofovir (TFV) disoproxil fumarate (TDF)-based HIV pre-exposure prophylaxis (PrEP', 'HIV pre-exposure prophylaxis']","['Plasma and hair FTC/TFV levels', 'Hair and plasma', 'plasma concentrations', 'FTC/TFV concentrations']","[{'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}, {'cui': 'C1264637', 'cui_str': 'Substance amount'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0039725', 'cui_str': 'Kingdom of Thailand'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C4517735', 'cui_str': '350'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0439539', 'cui_str': 'Heavy sensation quality'}, {'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0909839', 'cui_str': 'emtricitabine'}, {'cui': 'C0220833', 'cui_str': 'fumarate'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1096319', 'cui_str': 'HIV pre-exposure prophylaxis'}]","[{'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0018494', 'cui_str': 'Hair'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",350.0,0.0409221,"Similar results were found for plasma concentrations by site and arm, but older age and greater number of sex partners were associated with higher concentrations.","[{'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Velloza', 'Affiliation': 'Department of Global Health, University of Washington, Seattle, WA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Bacchetti', 'Affiliation': 'School of Medicine, University of California at San Francisco, San Francisco, CA.'}, {'ForeName': 'Craig W', 'Initials': 'CW', 'LastName': 'Hendrix', 'Affiliation': 'Department of Medicine, Johns Hopkins University, Baltimore, MD.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Murnane', 'Affiliation': 'School of Medicine, University of California at San Francisco, San Francisco, CA.'}, {'ForeName': 'James P', 'Initials': 'JP', 'LastName': 'Hughes', 'Affiliation': 'Department of Global Health, University of Washington, Seattle, WA.'}, {'ForeName': 'Maoji', 'Initials': 'M', 'LastName': 'Li', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Seattle, WA.'}, {'ForeName': 'Marcel E', 'Initials': 'ME', 'LastName': 'Curlin', 'Affiliation': 'U.S. Centers for Disease Control and Prevention, Atlanta, GA.'}, {'ForeName': 'Timothy H', 'Initials': 'TH', 'LastName': 'Holtz', 'Affiliation': 'U.S. Centers for Disease Control and Prevention, Atlanta, GA.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Mannheimer', 'Affiliation': 'Columbia University, New York, NY.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Marzinke', 'Affiliation': 'Department of Medicine, Johns Hopkins University, Baltimore, MD.'}, {'ForeName': 'K Rivet', 'Initials': 'KR', 'LastName': 'Amico', 'Affiliation': 'Department of Health Behavior and Health Education, School of Public Health, University of Michigan, Ann Arbor, MI.'}, {'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Liu', 'Affiliation': 'San Francisco Department of Public Health, San Francisco, CA.'}, {'ForeName': 'Estelle', 'Initials': 'E', 'LastName': 'Piwowar-Manning', 'Affiliation': 'Department of Medicine, Johns Hopkins University, Baltimore, MD.'}, {'ForeName': 'Susan H', 'Initials': 'SH', 'LastName': 'Eshleman', 'Affiliation': 'Department of Medicine, Johns Hopkins University, Baltimore, MD.'}, {'ForeName': 'Bonnie J', 'Initials': 'BJ', 'LastName': 'Dye', 'Affiliation': 'FHI 360, Durham, NC.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Gandhi', 'Affiliation': 'School of Medicine, University of California at San Francisco, San Francisco, CA.'}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Grant', 'Affiliation': 'School of Medicine, University of California at San Francisco, San Francisco, CA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of acquired immune deficiency syndromes (1999),['10.1097/QAI.0000000000002128'] 288,31240854,Placental growth factor testing for suspected pre-eclampsia: a cost-effectiveness analysis.,"OBJECTIVE To calculate the cost-effectiveness of implementing PlGF testing alongside a clinical management algorithm in maternity services in the UK, compared with current standard care. DESIGN Cost-effectiveness analysis. SETTING Eleven maternity units participating in the PARROT stepped-wedge cluster-randomised controlled trial. POPULATION Women presenting with suspected pre-eclampsia between 20 +0 and 36 +6  weeks' gestation. METHODS Monte Carlo simulation utilising resource use data and maternal adverse outcomes. MAIN OUTCOME MEASURES Cost per maternal adverse outcome prevented. RESULTS Clinical care with PlGF testing costs less than current standard practice and resulted in fewer maternal adverse outcomes. There is a total cost-saving of UK£149 per patient tested, when including the cost of the test. This represents a potential cost-saving of UK£2,891,196 each year across the NHS in England. CONCLUSIONS Clinical care with PlGF testing is associated with the potential for cost-savings per participant tested when compared with current practice via a reduction in outpatient attendances, and improves maternal outcomes. This economic analysis supports a role for implementation of PlGF testing in antenatal services for the assessment of women with suspected pre-eclampsia. TWEETABLE ABSTRACT Placental growth factor testing for suspected pre-eclampsia is cost-saving and improves maternal outcomes.",2019,This economic analysis supports a role for implementation of PlGF testing into antenatal services for the assessment of women with suspected preeclampsia.,"['Suspected Preeclampsia', ""women presenting with suspected preeclampsia between 20 +0 and 36 +6 weeks' gestation"", 'women with suspected preeclampsia', 'Setting 11 maternity units participating in the PARROT stepped wedge cluster randomised controlled trial']",['Placental Growth Factor Testing'],"['cost per maternal adverse outcome prevented', 'maternal adverse outcomes', 'maternal outcomes', 'total cost saving']","[{'cui': 'C0750491', 'cui_str': 'Suspected (qualifier value)'}, {'cui': 'C0032914', 'cui_str': 'EPH Toxemias'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C1384490', 'cui_str': 'Psittacidae'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0439639', 'cui_str': 'Wedge (physical object)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0018284', 'cui_str': 'Growth factor (substance)'}]","[{'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0085550', 'cui_str': 'Saving, Cost'}]",,0.183715,This economic analysis supports a role for implementation of PlGF testing into antenatal services for the assessment of women with suspected preeclampsia.,"[{'ForeName': 'K E', 'Initials': 'KE', 'LastName': 'Duhig', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, King's College London, London, UK.""}, {'ForeName': 'P T', 'Initials': 'PT', 'LastName': 'Seed', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, King's College London, London, UK.""}, {'ForeName': 'J E', 'Initials': 'JE', 'LastName': 'Myers', 'Affiliation': 'The Division of Developmental Biology and Medicine, University of Manchester, Manchester, UK.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Bahl', 'Affiliation': 'University Hospitals Bristol NHS Foundation Trust, Bristol, UK.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Bambridge', 'Affiliation': 'Kingston Hospital NHS Foundation Trust, Kingston upon Thames, UK.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Barnfield', 'Affiliation': 'North Bristol NHS Trust, Bristol, UK.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Ficquet', 'Affiliation': 'Royal United Hospitals Bath, Bath, UK.'}, {'ForeName': 'J C', 'Initials': 'JC', 'LastName': 'Girling', 'Affiliation': 'West Middlesex University Hospital, Chelsea and Westminster Hospital NHS Foundation Trust, London, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Khalil', 'Affiliation': ""Fetal Medicine Unit, St George's Hospital, St George's University of London, London, UK.""}, {'ForeName': 'A H', 'Initials': 'AH', 'LastName': 'Shennan', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, King's College London, London, UK.""}, {'ForeName': 'L C', 'Initials': 'LC', 'LastName': 'Chappell', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, King's College London, London, UK.""}, {'ForeName': 'R M', 'Initials': 'RM', 'LastName': 'Hunter', 'Affiliation': 'Research Department of Primary Care and Population Health, University College London, London, UK.'}]",BJOG : an international journal of obstetrics and gynaecology,['10.1111/1471-0528.15855'] 289,32297162,"Lidocaine as an element of multimodal analgesic therapy in major spine surgical procedures in children: a prospective, randomized, double-blind study.","BACKGROUND Introducing the principles of multimodal analgesic therapy is necessary to provide appropriate comfort for the patient after surgery. The main objective of the study was evaluating the influence of perioperative intravenous (i.v.) lidocaine infusion on postoperative morphine requirements during the first 48 h postoperatively in children undergoing major spine surgery. MATERIALS AND METHODS Prospective, randomized, double-blind study: 41 children, qualified to multilevel spine surgery, were randomly divided into two treatment groups: lidocaine and placebo (control). The lidocaine group received lidocaine as a bolus of 1.5 mg/kg over 30 minutes, followed by a continuous infusion at 1 mg/kg/h to 6 hours after surgery. The protocol of perioperative management was identical for all patients. MEASUREMENTS morphine demand, intensity of postoperative pain (the Numerical Rating Scale), oral feeding initiation time, first attempts at assuming erect position, postoperative quality of life (the Acute Short-form /SF-12/ health survey). RESULTS Patient data did not differ demographically. Compared to the control group, lidocaine treatment reduced the demand for morphine during the first 24h [95% CI 0.13 (0.11-0.28) mg/kg, p = 0.0122], 48h [95% CI 0.46 (0.22-0.52) mg/kg, p = 0.0299] after surgery and entire hospitalization [95% CI 0.58 (0.19-0.78) mg/kg, p = 0.04]; postoperative pain intensity; nutritional withdrawal period [introduction of liquid diet (p = 0.024) and solid diet (p = 0.012)], and accelerated the adoption of an upright position [sitting (p = 0.048); walking (p = 0.049)]. The SF-12 generic health survey did not differ between groups before operation, 2 months and 4 years after surgery. CONCLUSIONS Perioperative lidocaine administration, as a part of the applied analgesic therapy regimen, may decrease postoperative opioid demand and accelerates convalescence of children undergoing major surgery.",2020,"Compared to the control group, lidocaine treatment reduced the demand for morphine during the first 24h [95% CI 0.13 (0.11-0.28) mg/kg, p = 0.0122], 48h [95% CI 0.46 (0.22-0.52) mg/kg, p = 0.0299] after surgery and entire hospitalization","['children undergoing major surgery', '41 children, qualified to multilevel spine surgery', 'major spine surgical procedures in children', 'children undergoing major spine surgery']","['Lidocaine', 'lidocaine', 'lidocaine and placebo (control']","['demand for morphine', 'postoperative morphine requirements', 'entire hospitalization', 'postoperative pain intensity; nutritional withdrawal period [introduction of liquid diet', 'SF-12 generic health survey', 'morphine demand, intensity of postoperative pain (the Numerical Rating Scale), oral feeding initiation time, first attempts at assuming erect position, postoperative quality of life (the Acute Short-form /SF-12/ health survey', 'adoption of an upright position [sitting']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0920347', 'cui_str': 'Procedure on spinal cord'}, {'cui': 'C0037949', 'cui_str': 'Structure of vertebral column'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}]","[{'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0439751', 'cui_str': 'Entire'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C0301571', 'cui_str': 'Liquid diet'}, {'cui': 'C0085155', 'cui_str': 'Generic Drugs'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0001593', 'cui_str': 'Adoption'}, {'cui': 'C0037216', 'cui_str': 'SITS'}]",41.0,0.143157,"Compared to the control group, lidocaine treatment reduced the demand for morphine during the first 24h [95% CI 0.13 (0.11-0.28) mg/kg, p = 0.0122], 48h [95% CI 0.46 (0.22-0.52) mg/kg, p = 0.0299] after surgery and entire hospitalization","[{'ForeName': 'Ilona', 'Initials': 'I', 'LastName': 'Batko', 'Affiliation': ""Department of Anesthesiology and Intensive Care, University Children's Hospital, 265 Wielicka St, 30-663, Cracow, Poland. ilona.batko@poczta.onet.pl.""}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Kościelniak-Merak', 'Affiliation': ""Department of Clinical Biochemistry, University Children's Hospital, Jagiellonian University Medical College, Cracow, Poland.""}, {'ForeName': 'Przemysław J', 'Initials': 'PJ', 'LastName': 'Tomasik', 'Affiliation': ""Department of Clinical Biochemistry, University Children's Hospital, Jagiellonian University Medical College, Cracow, Poland.""}, {'ForeName': 'Krzysztof', 'Initials': 'K', 'LastName': 'Kobylarz', 'Affiliation': ""Department of Anesthesiology and Intensive Care, University Children's Hospital, 265 Wielicka St, 30-663, Cracow, Poland.""}, {'ForeName': 'Jerzy', 'Initials': 'J', 'LastName': 'Wordliczek', 'Affiliation': 'Department of Anesthesiology and Intensive Care, Jagiellonian University Medical College, Cracow, Poland.'}]",Pharmacological reports : PR,['10.1007/s43440-020-00100-7'] 290,32297937,Galactose Ingested with a High-Fat Beverage Increases Postprandial Lipemia Compared with Glucose but Not Fructose Ingestion in Healthy Men.,"BACKGROUND Fructose ingestion with a high-fat beverage increases postprandial lipemia when compared with glucose. It is unknown whether other sugars, such as galactose, also increase postprandial lipemia. OBJECTIVES The objective was to assess whether galactose ingestion within a high-fat beverage increases postprandial lipemia relative to glucose or fructose. METHODS Two experiments were conducted, which contrasted different test drinks under otherwise standardized conditions. In Experiment 1, 10 nonobese men (age: 22 ± 1 y; BMI, 23.5 ± 2.2 kg/2) ingested either galactose or glucose (0.75 g supplemented carbohydrate per⋅kilogram body mass) within a high-fat test drink (0.94 g fat per kilogram body mass). In Experiment 2, a separate group of 9 nonobese men (age: 26 ± 6 y; BMI: 23.5 ± 2.6 kg/m2) ingested either galactose or fructose (identical doses as those in Experiment 1) within the same high-fat test drink. Capillary blood was sampled before and at frequent intervals after ingestion of the test drinks for a 300-min period to determine plasma triacylglycerol, glucose, lactate, nonesterified fatty acid, and insulin concentrations. Paired t tests and 2-way, repeated-measures ANOVA were used to compare conditions within each experiment. RESULTS The incremental AUC for triacylglycerol was greater following galactose ingestion compared with glucose (127 ± 59 compared with 80 ± 48 mmol⋅L-1 × 300 min, respectively; P = 0.04) but not compared with fructose (136 ± 74 compared with 133 ± 63 mmol⋅L-1 ×300 min, respectively; P = 0.91). Plasma lactate concentrations also increased to a greater extent with galactose compared with glucose ingestion (time-condition interaction: P < 0.001) but not fructose ingestion (time-condition interaction: P = 0.17). CONCLUSIONS Galactose ingestion within a high-fat beverage exacerbates postprandial lipemia and plasma lactate concentrations compared with glucose but not fructose in nonobese men. These data suggest that galactose metabolism may be more similar to fructose than to glucose, providing a rationale to reassess the metabolic fate of galactose ingestion in humans. This trial was registered at clinicaltrials.gov as NCT03439878.",2020,"Plasma lactate concentrations also increased to a greater extent with galactose compared with glucose ingestion (time-condition interaction: P < 0.001) but not fructose ingestion (time-condition interaction: P = 0.17). ","['10 nonobese men (age: 22\xa0±\xa01 y; BMI, 23.5\xa0±\xa02.2 kg/2) ingested either', 'nonobese men', '9 nonobese men (age: 26\xa0±\xa06 y; BMI: 23.5\xa0±\xa02.6 kg/m2) ingested either', 'Healthy Men']","['galactose or glucose (0.75 g supplemented carbohydrate per⋅kilogram body mass) within a high-fat test drink', 'galactose or fructose (identical doses as those in Experiment 1) within the same high-fat test drink']","['postprandial lipemia relative to glucose or fructose', 'Capillary blood', 'Plasma lactate concentrations', 'incremental AUC for triacylglycerol', 'postprandial lipemia', 'Postprandial Lipemia', 'plasma triacylglycerol, glucose, lactate, nonesterified fatty acid, and insulin concentrations']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517629', 'cui_str': '2.2'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C4517633', 'cui_str': '2.6'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}]","[{'cui': 'C0016945', 'cui_str': 'Galactose'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C4068882', 'cui_str': '0.75'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0016745', 'cui_str': 'Fructose'}, {'cui': 'C0205280', 'cui_str': 'Identical'}]","[{'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0020473', 'cui_str': 'Hyperlipidemia'}, {'cui': 'C3875154', 'cui_str': 'Relative to'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0016745', 'cui_str': 'Fructose'}, {'cui': 'C0229666', 'cui_str': 'Capillary blood'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}]",2.0,0.0461634,"Plasma lactate concentrations also increased to a greater extent with galactose compared with glucose ingestion (time-condition interaction: P < 0.001) but not fructose ingestion (time-condition interaction: P = 0.17). ","[{'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Watkins', 'Affiliation': 'Department for Health, University of Bath, Bath, United Kingdom.'}, {'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'Simpson', 'Affiliation': 'Institute for Sport, Physical Activity & Leisure, Leeds Beckett University, Leeds, United Kingdom.'}, {'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'Betts', 'Affiliation': 'Department for Health, University of Bath, Bath, United Kingdom.'}, {'ForeName': 'Dylan', 'Initials': 'D', 'LastName': 'Thompson', 'Affiliation': 'Department for Health, University of Bath, Bath, United Kingdom.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Holliday', 'Affiliation': 'Institute for Sport, Physical Activity & Leisure, Leeds Beckett University, Leeds, United Kingdom.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Deighton', 'Affiliation': 'Institute for Sport, Physical Activity & Leisure, Leeds Beckett University, Leeds, United Kingdom.'}, {'ForeName': 'Javier T', 'Initials': 'JT', 'LastName': 'Gonzalez', 'Affiliation': 'Department for Health, University of Bath, Bath, United Kingdom.'}]",The Journal of nutrition,['10.1093/jn/nxaa105'] 291,31765640,Impact of treatment for fecal incontinence on constipation symptoms.,"OBJECTIVE Defecatory symptoms, such as a sense of incomplete emptying and straining with bowel movements, are paradoxically present in women with fecal incontinence. Treatments for fecal incontinence, such as loperamide and biofeedback, can worsen or improve defecatory symptoms, respectively. The primary aim of this study was to compare changes in constipation symptoms in women undergoing treatment for fecal incontinence with education only, loperamide, anal muscle exercises with biofeedback or both loperamide and biofeedback. Our secondary aim was to compare changes in constipation symptoms among responders and nonresponders to fecal incontinence treatment. STUDY DESIGN This was a planned secondary analysis of a randomized controlled trial comparing 2 first-line therapies for fecal incontinence in a 2 × 2 factorial design. Women with at least monthly fecal incontinence and normal stool consistency were randomized to 4 groups: (1) oral placebo plus education only, (2) oral loperamide plus education only, (3) placebo plus anorectal manometry-assisted biofeedback, and (4) loperamide plus biofeedback. Defecatory symptoms were measured using the Patient Assessment of Constipation Symptoms questionnaire at baseline, 12 weeks, and 24 weeks. The Patient Assessment of Constipation Symptoms consists of 12 items that contribute to a global score and 3 subscales: stool characteristics/symptoms (hardness of stool, size of stool, straining, inability to pass stool), rectal symptoms (burning, pain, bleeding, incomplete bowel movement), and abdominal symptoms (discomfort, pain, bloating, cramps). Scores for each subscale as well as the global score range from 0 (no symptoms) to 4 (maximum score), with negative change scores representing improvement in defecatory symptoms. Responders to fecal incontinence treatment were defined as women with a minimally important clinical improvement of ≥5 points on the St Mark's (Vaizey) scale between baseline and 24 weeks. Intent-to-treat analysis was performed using a longitudinal mixed model, controlling for baseline scores, to estimate changes in Patient Assessment of Constipation Symptoms scores from baseline through 24 weeks. RESULTS At 24 weeks, there were small changes in Patient Assessment of Constipation Symptoms global scores in all 4 groups: oral placebo plus education (-0.3; 95% confidence interval, -0.5 to -0.1), loperamide plus education (-0.1, 95% confidence interval, -0.3 to0.0), oral placebo plus biofeedback (-0.3, 95% confidence interval, -0.4 to -0.2), and loperamide plus biofeedback (-0.3, 95% confidence interval, -0.4 to -0.2). No differences were observed in change in Patient Assessment of Constipation Symptoms scores between women randomized to placebo plus education and those randomized to loperamide plus education (P = .17) or placebo plus biofeedback (P = .82). Change in Patient Assessment of Constipation Symptoms scores in women randomized to combination loperamide plus biofeedback therapy was not different from that of women randomized to treatment with loperamide or biofeedback alone. Responders had greater improvement in Patient Assessment of Constipation Symptoms scores than nonresponders (-0.4; 95% confidence interval, -0.5 to -0.3 vs -0.2; 95% confidence interval, -0.3 to -0.0, P < .01, mean difference, 0.2, 95% confidence interval, 0.1-0.4). CONCLUSION Change in constipation symptoms following treatment of fecal incontinence in women are small and are not significantly different between groups. Loperamide treatment for fecal incontinence does not worsen constipation symptoms among women with normal consistency stool. Women with clinically significant improvement in fecal incontinence symptoms report greater improvement in constipation symptoms.",2020,No differences were observed in change in PAC-SYM scores between women randomized to placebo plus education and those randomized to loperamide plus education (p=0.17) or placebo plus biofeedback (p=0.82).,"['Women with at least monthly FI and normal stool consistency', 'Fecal Incontinence on Constipation Symptoms', 'women with fecal incontinence (FI', 'women undergoing treatment for FI with education only', 'women with normal consistency stool']","['placebo', 'placebo plus biofeedback', 'loperamide, anal muscle exercises with biofeedback, or both loperamide and biofeedback', 'combination loperamide plus biofeedback therapy', 'oral placebo plus education only, 2) oral loperamide plus education only, 3) placebo plus anorectal manometry-assisted biofeedback and 4) loperamide plus biofeedback']","['PAC-SYM scores', 'PAC-SYM global scores', 'constipation symptoms', 'loperamide plus biofeedback', 'FI symptoms', 'loperamide plus education', 'Constipation Symptoms (PAC-SYM) questionnaire', 'global score and 3 subscales: stool characteristics/symptoms (hardness of stool, size of stool, straining, inability to pass stool), rectal symptoms (burning, pain, bleeding, incomplete bowel movement), and abdominal symptoms (discomfort, pain, bloating, cramps', ""St. Mark's (Vaizey) scale"", 'Defecatory symptoms']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0332529', 'cui_str': 'Consistency finding'}, {'cui': 'C0015732', 'cui_str': 'Bowel Incontinence'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0332530', 'cui_str': 'Normal consistency (finding)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0678663', 'cui_str': 'Biofeedback, function (observable entity)'}, {'cui': 'C0023992', 'cui_str': 'Loperamide'}, {'cui': 'C2939124', 'cui_str': 'Anal (qualifier value)'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C3652856', 'cui_str': 'loperamide, combinations'}, {'cui': 'C0005491', 'cui_str': 'Feedback, Psychophysiologic'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0374190', 'cui_str': 'Anorectal manometry'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}]","[{'cui': 'C0182281', 'cui_str': 'Picture Archiving and Communication Systems'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0023992', 'cui_str': 'Loperamide'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0678663', 'cui_str': 'Biofeedback, function (observable entity)'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0018599', 'cui_str': 'Hardness'}, {'cui': 'C0426739', 'cui_str': 'Stool size'}, {'cui': 'C0558921', 'cui_str': 'Rectal symptoms (finding)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205257', 'cui_str': 'Incomplete (qualifier value)'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0740651', 'cui_str': 'Abdominal symptom'}, {'cui': 'C2364135', 'cui_str': 'Discomfort (finding)'}, {'cui': 'C1446787', 'cui_str': 'Cramping'}, {'cui': 'C0522501', 'cui_str': 'Massive (qualifier value)'}, {'cui': 'C0222045'}]",,0.676002,No differences were observed in change in PAC-SYM scores between women randomized to placebo plus education and those randomized to loperamide plus education (p=0.17) or placebo plus biofeedback (p=0.82).,"[{'ForeName': 'Uduak U', 'Initials': 'UU', 'LastName': 'Andy', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Pennsylvania, Philadelphia, PA. Electronic address: uduakumoh.andy@uphs.upenn.edu.'}, {'ForeName': 'J Eric', 'Initials': 'JE', 'LastName': 'Jelovsek', 'Affiliation': 'Department of Obstetrics and Gynecology, Duke University Medical Center, Durham, NC.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Carper', 'Affiliation': 'RTI International, Research Triangle Park, NC.'}, {'ForeName': 'Isuzu', 'Initials': 'I', 'LastName': 'Meyer', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Alabama at Birmingham, Birmingham, AL.'}, {'ForeName': 'Keisha Y', 'Initials': 'KY', 'LastName': 'Dyer', 'Affiliation': 'Department of Obstetrics and Gynecology, Kaiser Permanente, San Diego, CA.'}, {'ForeName': 'Rebecca G', 'Initials': 'RG', 'LastName': 'Rogers', 'Affiliation': ""Department of Women's Health, Dell Medical School, University of Texas at Austin. Austin, TX; University of New Mexico Health Sciences Center, Albuquerque, NM.""}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Mazloomdoost', 'Affiliation': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, MD.'}, {'ForeName': 'Nicole B', 'Initials': 'NB', 'LastName': 'Korbly', 'Affiliation': 'Department of Obstetrics and Gynecology, Alpert Medical School of Brown University, Providence, RI.'}, {'ForeName': 'Jessica C', 'Initials': 'JC', 'LastName': 'Sassani', 'Affiliation': 'Department of Obstetrics, Gynecology, and Reproductive Sciences, University of Pittsburgh Medical Center, Pittsburgh, PA.'}, {'ForeName': 'Marie G', 'Initials': 'MG', 'LastName': 'Gantz', 'Affiliation': 'RTI International, Research Triangle Park, NC.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American journal of obstetrics and gynecology,['10.1016/j.ajog.2019.11.1256'] 292,31810378,Impact of Sleep Deprivation on Respiratory Motor Output and Endurance. A Physiological Study.,"Rationale: Sleep deprivation can alter endurance of skeletal muscles, but its impact on respiratory command is unknown. Objectives: We aimed to assess the effect of sleep deprivation on respiratory motor output and inspiratory endurance. Methods: Inspiratory endurance was investigated twice in random order, following a normal sleep night and a sleepless night. Healthy participants were asked to breathe as long as possible until task failure against a moderate inspiratory threshold constraint. Transdiaphragmatic pressure and diaphragm electrical activity were measured throughout the trial to assess pressure output of the diaphragm and overall respiratory motor output. Cortical contribution to respiratory motor output was assessed by measurement of preinspiratory motor potential amplitude and by cervical magnetic simulation. Measurements and Main Results: Twenty healthy male participants were studied. Time to task failure was significantly shorter after sleep deprivation than after normal sleep: (30 min [interquartile range [IQR], 17-41] vs. 60 min [IQR, 45-60], P  = 0.002). At the beginning of the trial, preinspiratory motor potential amplitude was significantly lower in the sleep-deprivation condition (4.5 μV [IQR, 2.5-6.4] vs. 7.3 μV [IQR, 4.3-10.4], P  = 0.02) and correlated significantly with the duration of the endurance trial. In the sleep-deprivation condition, preinspiratory motor potential amplitude, electrical activity of the diaphragm, pressure output of the diaphragm, and Vt decreased and the respiratory rate increased significantly from the beginning to the end of the trial. Such decreases did not occur in the normal-sleep condition. Conclusions: One night of sleep deprivation reduces respiratory motor output by altering its cortical component with subsequent reduction of inspiratory endurance by half. These results suggest that altered sleep triggers severe brain dysfunctions that could precipitate respiratory failure.",2020,"At the beginning of the trial, preinspiratory motor potential amplitude was significantly lower in the sleep-deprivation condition (4.5 μV [IQR, 2.5-6.4] vs. 7.3 μV [IQR, 4.3-10.4], P  = 0.02) and correlated significantly with the duration of the endurance trial.","['Healthy participants', 'Twenty healthy male participants']","['Sleep Deprivation', 'sleep deprivation']","['sleep-deprivation condition', 'Time to task failure', 'Transdiaphragmatic pressure and diaphragm electrical activity', 'respiratory motor output and inspiratory endurance', 'Respiratory Motor Output and Endurance', 'sleep-deprivation condition, preinspiratory motor potential amplitude, electrical activity of the diaphragm, pressure output of the diaphragm, and Vt decreased and the respiratory rate']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0037316', 'cui_str': 'Sleep deprivation'}]","[{'cui': 'C0037316', 'cui_str': 'Sleep deprivation'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0205504', 'cui_str': 'Transdiaphragmatic approach'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0011980', 'cui_str': 'Diaphragm structure'}, {'cui': 'C0234388', 'cui_str': 'Electrical activity of brain'}, {'cui': 'C3251815', 'cui_str': 'Measurement of fluid output'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0429441', 'cui_str': 'Motor-potential'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0231832', 'cui_str': 'Respiratory rate'}]",20.0,0.107918,"At the beginning of the trial, preinspiratory motor potential amplitude was significantly lower in the sleep-deprivation condition (4.5 μV [IQR, 2.5-6.4] vs. 7.3 μV [IQR, 4.3-10.4], P  = 0.02) and correlated significantly with the duration of the endurance trial.","[{'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Rault', 'Affiliation': 'INSERM, CIC 1402, Equipe Alive, Faculté de Médecine et de Pharmacie, Université de Poitiers, Poitiers, France.'}, {'ForeName': 'Aude', 'Initials': 'A', 'LastName': 'Sangaré', 'Affiliation': 'Service de Neurophysiologie Clinique.'}, {'ForeName': 'Véronique', 'Initials': 'V', 'LastName': 'Diaz', 'Affiliation': 'INSERM, CIC 1402, Equipe Alive, Faculté de Médecine et de Pharmacie, Université de Poitiers, Poitiers, France.'}, {'ForeName': 'Stéphanie', 'Initials': 'S', 'LastName': 'Ragot', 'Affiliation': 'INSERM, CIC 1402, Equipe Alive, Faculté de Médecine et de Pharmacie, Université de Poitiers, Poitiers, France.'}, {'ForeName': 'Jean-Pierre', 'Initials': 'JP', 'LastName': 'Frat', 'Affiliation': 'INSERM, CIC 1402, Equipe Alive, Faculté de Médecine et de Pharmacie, Université de Poitiers, Poitiers, France.'}, {'ForeName': 'Mathieu', 'Initials': 'M', 'LastName': 'Raux', 'Affiliation': 'Sorbonne Universités, INSERM, UMRS1158 Neurophysiologie Respiratoire Expérimentale et Clinique, Paris, France.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Similowski', 'Affiliation': 'Sorbonne Universités, INSERM, UMRS1158 Neurophysiologie Respiratoire Expérimentale et Clinique, Paris, France.'}, {'ForeName': 'René', 'Initials': 'R', 'LastName': 'Robert', 'Affiliation': 'INSERM, CIC 1402, Equipe Alive, Faculté de Médecine et de Pharmacie, Université de Poitiers, Poitiers, France.'}, {'ForeName': 'Arnaud W', 'Initials': 'AW', 'LastName': 'Thille', 'Affiliation': 'INSERM, CIC 1402, Equipe Alive, Faculté de Médecine et de Pharmacie, Université de Poitiers, Poitiers, France.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Drouot', 'Affiliation': 'INSERM, CIC 1402, Equipe Alive, Faculté de Médecine et de Pharmacie, Université de Poitiers, Poitiers, France.'}]",American journal of respiratory and critical care medicine,['10.1164/rccm.201904-0819OC'] 293,31016887,Muscle wasting and function after muscle activation and early protocol-based physiotherapy: an explorative trial.,"BACKGROUND Early mobilization improves physical independency of critically ill patients at hospital discharge in a general intensive care unit (ICU)-cohort. We aimed to investigate clinical and molecular benefits or detriments of early mobilization and muscle activating measures in a high-risk ICU-acquired weakness cohort. METHODS Fifty patients with a SOFA score ≥9 within 72 h after ICU admission were randomized to muscle activating measures such as neuromuscular electrical stimulation or whole-body vibration in addition to early protocol-based physiotherapy (intervention) or early protocol-based physiotherapy alone (control). Muscle strength and function were assessed by Medical Research Council (MRC) score, handgrip strength and Functional Independence Measure at first awakening, ICU discharge, and 12 month follow-up. Patients underwent open surgical muscle biopsy on day 15. We investigated the impact of muscle activating measures in addition to early protocol-based physiotherapy on muscle strength and function as well as on muscle wasting, morphology, and homeostasis in patients with sepsis and ICU-acquired weakness. We compared the data with patients treated with common physiotherapeutic practice (CPP) earlier. RESULTS ICU-acquired weakness occurs within the entire cohort, and muscle activating measures did not improve muscle strength or function at first awakening (MRC median [IQR]: CPP 3.3 [3.0-4.3]; control 3.0 [2.7-3.4]; intervention 3.0 [2.1-3.8]; P > 0.05 for all), ICU discharge (MRC median [IQR]: CPP 3.8 [3.4-4.4]; control 3.9 [3.3-4.0]; intervention 3.6 [2.8-4.0]; P > 0.05 for all), and 12 month follow-up (MRC median [IQR]: control 5.0 [4.3-5.0]; intervention 4.8 [4.3-5.0]; P = 0.342 for all). No signs of necrosis or inflammatory infiltration were present in the histological analysis. Myocyte cross-sectional area in the intervention group was significantly larger in comparison with the control group (type I +10%; type IIa +13%; type IIb +3%; P < 0.001 for all) and CPP (type I +36%; type IIa +49%; type IIb +65%; P < 0.001 for all). This increase was accompanied by an up-regulated gene expression for myosin heavy chains (fold change median [IQR]: MYH1 2.3 [1.1-2.7]; MYH2 0.7 [0.2-1.8]; MYH4 5.1 [2.2-15.3]) and an unaffected gene expression for TRIM63, TRIM62, and FBXO32. CONCLUSIONS In our patients with sepsis syndrome at high risk for ICU-acquired weakness muscle activating measures in addition to early protocol-based physiotherapy did not improve muscle strength or function at first awakening, ICU discharge, or 12 month follow-up. Yet it prevented muscle atrophy.",2019,Myocyte cross-sectional area in the intervention group was significantly larger in comparison with the control group (type I +10%; type IIa +13%; type IIb +3%; P < 0.001 for all) and CPP (type I +36%; type IIa +49%; type IIb +65%; P < 0.001 for all).,"['Fifty patients with a SOFA score ≥9 within 72\xa0h after ICU admission', 'patients treated with common physiotherapeutic practice (CPP) earlier', 'patients with sepsis and ICU-acquired weakness', 'critically ill patients at hospital discharge in a general intensive care unit (ICU)-cohort']","['muscle activation and early protocol-based physiotherapy', 'muscle activating measures such as neuromuscular electrical stimulation or whole-body vibration in addition to early protocol-based physiotherapy (intervention) or early protocol-based physiotherapy alone (control', 'open surgical muscle biopsy']","['Muscle strength and function', 'Myocyte cross-sectional area', 'unaffected gene expression for TRIM63, TRIM62, and FBXO32', 'muscle strength or function', 'Medical Research Council (MRC) score, handgrip strength and Functional Independence Measure at first awakening, ICU discharge', 'necrosis or inflammatory infiltration', 'ICU discharge']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0205214', 'cui_str': 'Common (qualifier value)'}, {'cui': 'C0243026', 'cui_str': 'Sepsis'}, {'cui': 'C4087120', 'cui_str': 'Intensive care unit acquired weakness'}, {'cui': 'C0010340', 'cui_str': 'Critically Ill'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}]","[{'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0013786', 'cui_str': 'Electrical Stimulation'}, {'cui': 'C0444584', 'cui_str': 'Whole body (qualifier value)'}, {'cui': 'C0459800', 'cui_str': 'Vibration'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0185283', 'cui_str': 'Biopsy of muscle (procedure)'}]","[{'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0596981', 'cui_str': 'Myocytes'}, {'cui': 'C0205203', 'cui_str': 'Crossed (qualifier value)'}, {'cui': 'C0205155', 'cui_str': 'Sectional (qualifier value)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0017262', 'cui_str': 'Gene Expression'}, {'cui': 'C0079816', 'cui_str': 'Medical Research'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0451172', 'cui_str': 'Functional independence measure (assessment scale)'}, {'cui': 'C1720052', 'cui_str': 'Awakening'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0027540', 'cui_str': 'Necrosis'}, {'cui': 'C0302158', 'cui_str': 'Inflammatory infiltration'}]",50.0,0.064542,Myocyte cross-sectional area in the intervention group was significantly larger in comparison with the control group (type I +10%; type IIa +13%; type IIb +3%; P < 0.001 for all) and CPP (type I +36%; type IIa +49%; type IIb +65%; P < 0.001 for all).,"[{'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Wollersheim', 'Affiliation': 'Department of Anesthesiology and Operative Intensive Care Medicine (CCM, CVK), Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany.'}, {'ForeName': 'Julius J', 'Initials': 'JJ', 'LastName': 'Grunow', 'Affiliation': 'Department of Anesthesiology and Operative Intensive Care Medicine (CCM, CVK), Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany.'}, {'ForeName': 'Niklas M', 'Initials': 'NM', 'LastName': 'Carbon', 'Affiliation': 'Department of Anesthesiology and Operative Intensive Care Medicine (CCM, CVK), Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany.'}, {'ForeName': 'Kurt', 'Initials': 'K', 'LastName': 'Haas', 'Affiliation': 'Department of Anesthesiology and Operative Intensive Care Medicine (CCM, CVK), Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Malleike', 'Affiliation': 'Department of Anesthesiology and Operative Intensive Care Medicine (CCM, CVK), Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany.'}, {'ForeName': 'Sara F', 'Initials': 'SF', 'LastName': 'Ramme', 'Affiliation': 'Department of Anesthesiology and Operative Intensive Care Medicine (CCM, CVK), Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Schneider', 'Affiliation': 'Berlin Institute of Health (BIH), Berlin, Germany.'}, {'ForeName': 'Claudia D', 'Initials': 'CD', 'LastName': 'Spies', 'Affiliation': 'Department of Anesthesiology and Operative Intensive Care Medicine (CCM, CVK), Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany.'}, {'ForeName': 'Sven', 'Initials': 'S', 'LastName': 'Märdian', 'Affiliation': 'Center for Musculoskeletal Surgery, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany.'}, {'ForeName': 'Knut', 'Initials': 'K', 'LastName': 'Mai', 'Affiliation': 'Berlin Institute of Health (BIH), Berlin, Germany.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Spuler', 'Affiliation': 'Charité-Universitätsmedizin Berlin and Max Delbrück Center for Molecular Medicine in the Helmholtz Association, Experimental and Clinical Research Center (ECRC), Berlin, Germany.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Fielitz', 'Affiliation': 'Berlin Institute of Health (BIH), Berlin, Germany.'}, {'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Weber-Carstens', 'Affiliation': 'Department of Anesthesiology and Operative Intensive Care Medicine (CCM, CVK), Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt Universität zu Berlin, and Berlin Institute of Health, Berlin, Germany.'}]","Journal of cachexia, sarcopenia and muscle",['10.1002/jcsm.12428'] 294,31016897,Effectiveness of a multimodal intervention in functionally impaired older people with type 2 diabetes mellitus.,"BACKGROUND Type 2 diabetes, a highly prevalent chronic disease, is associated with increasing frailty and functional decline in older people. We aimed to evaluate the effectiveness of a multimodal intervention on functional performance in frail and pre-frail participants aged ≥70 years with type 2 diabetes mellitus. METHODS The MID-Frail study was a cluster-randomized multicenter clinical trial conducted in 74 trial sites across seven European countries. The trial recruited 964 participants who were aged >70 years [mean age in intervention group, 78.4 (SD 5.6) years, 49.2% male and 77.6 (SD 5.29) years, 52.4% male in usual care group], with type diabetes mellitus and determined to be frail or pre-frail using Fried's frailty phenotype. Participants were allocated by trial site to follow either usual care (UCG) or intervention procedures (IG). Intervention group participants received a multimodal intervention composed of (i) an individualized and progressive resistance exercise programme for 16 weeks; (ii) a structured diabetes and nutritional educational programme over seven sessions; and (iii) Investigator-linked training to ensure optimal diabetes care. Short Physical Performance Battery (SPPB) scores were used to assess change in functional performance at 12 months between the groups. An analysis of the cost-effectiveness of the intervention was undertaken using the incremental cost-effectiveness ratio (ICER). Secondary outcomes included mortality, hospitalization, institutionalization, quality of life, burden on caregivers, the frequency and severity of hypoglycaemia episodes, and the cost-effectiveness of the intervention. RESULTS After 12 months, IG participants had mean SPPB scores 0.85 points higher than those in the UCG (95% CI, 0.44 to 1.26, P < 0.0001). Dropouts were higher in frail participants and in the intervention group, but significant differences in SPPB between treatment groups remained consistent after sensitivity analysis. Estimates suggest a mean saving following intervention of 428.02 EUR (2016) per patient per year, with ICER analysis indicating a consistent benefit of the described health care intervention over usual care. No statistically significant differences between groups were detected in any of the other secondary outcomes. CONCLUSIONS We have demonstrated that a 12 month structured multimodal intervention programme across several clinical settings in different European countries leads to a clinically relevant and cost-effective improvement in the functional status of older frail and pre-frail participants with type 2 diabetes mellitus.",2019,"Dropouts were higher in frail participants and in the intervention group, but significant differences in SPPB between treatment groups remained consistent after sensitivity analysis.","['older frail and pre-frail participants with type 2 diabetes mellitus', 'older people with type 2 diabetes mellitus', 'frail and pre-frail participants aged ≥70\xa0years with type 2 diabetes mellitus', ""964 participants who were aged >70\xa0years [mean age in intervention group, 78.4 (SD 5.6)\xa0years, 49.2% male and 77.6 (SD 5.29)\xa0years, 52.4% male in usual care group], with type diabetes mellitus and determined to be frail or pre-frail using Fried's frailty phenotype"", '74 trial sites across seven European countries']","['usual care (UCG) or intervention procedures (IG', 'multimodal intervention composed of (i) an individualized and progressive resistance exercise programme for 16\xa0weeks; (ii) a structured diabetes and nutritional educational programme over seven sessions; and (iii) Investigator-linked training to ensure optimal diabetes care', 'multimodal intervention programme', 'multimodal intervention']","['incremental cost-effectiveness ratio (ICER', 'mortality, hospitalization, institutionalization, quality of life, burden on caregivers, the frequency and severity of hypoglycaemia episodes, and the cost-effectiveness of the intervention', 'SPPB', 'functional performance', 'Short Physical Performance Battery (SPPB) scores', 'mean SPPB scores']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4517794', 'cui_str': '5.6 (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C1510451', 'cui_str': 'Fries'}, {'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C1314763', 'cui_str': 'Phenotyping (qualifier value)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0454713', 'cui_str': 'European country (geographic location)'}]","[{'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0205329', 'cui_str': 'Progressive (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0035173', 'cui_str': 'Investigators'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0021629', 'cui_str': 'Institutionalization'}, {'cui': 'C0034380'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C3853978'}, {'cui': 'C4075289', 'cui_str': 'Short Physical Performance Battery score (observable entity)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",964.0,0.128605,"Dropouts were higher in frail participants and in the intervention group, but significant differences in SPPB between treatment groups remained consistent after sensitivity analysis.","[{'ForeName': 'Leocadio', 'Initials': 'L', 'LastName': 'Rodriguez-Mañas', 'Affiliation': 'Servicio de Geriatría, Hospital Universitario de Getafe, Madrid, Spain.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Laosa', 'Affiliation': 'Foundation for Biomedical Research-Hospital Universitario de Getafe, Madrid, Spain.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Vellas', 'Affiliation': 'Centre Hospitalier Universitaire de Toulouse, Toulouse, France.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Paolisso', 'Affiliation': 'University of Campania-Luigi Vanvitelli, Naples, Italy.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Topinkova', 'Affiliation': 'First Faculty of Medicine, Charles University, Prague, Czech Republic.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Oliva-Moreno', 'Affiliation': 'University Castilla La Mancha University, Toledo, Spain.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Bourdel-Marchasson', 'Affiliation': 'Centre Hospitalier Universitaire de Bordeaux, Bordeaux, France.'}, {'ForeName': 'Mikel', 'Initials': 'M', 'LastName': 'Izquierdo', 'Affiliation': 'IdiSNA, Navarra Institute for Health Research, Public University of Navarra, Pamplona, Spain.'}, {'ForeName': 'Kerry', 'Initials': 'K', 'LastName': 'Hood', 'Affiliation': 'Centre for Trials Research, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Andrej', 'Initials': 'A', 'LastName': 'Zeyfang', 'Affiliation': 'Ulm University, Ulm, Germany.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Gambassi', 'Affiliation': 'Università Cattolica Sacro Cuore, Rome, Italy.'}, {'ForeName': 'Mirko', 'Initials': 'M', 'LastName': 'Petrovic', 'Affiliation': 'Department of Geriatrics, Ghent University Hospital, Ghent, Belgium.'}, {'ForeName': 'Tim C', 'Initials': 'TC', 'LastName': 'Hardman', 'Affiliation': 'Niche Science & Technology Ltd, Richmond, UK.'}, {'ForeName': 'Mark J', 'Initials': 'MJ', 'LastName': 'Kelson', 'Affiliation': 'Department of Mathematics, University of Exeter, Exeter, UK.'}, {'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Bautmans', 'Affiliation': 'Gerontology Department, Vrije Universiteit Brussel, Brussels, Belgium.'}, {'ForeName': 'Gabor', 'Initials': 'G', 'LastName': 'Abellan', 'Affiliation': 'Centre Hospitalier Universitaire de Toulouse, Toulouse, France.'}, {'ForeName': 'Michelangela', 'Initials': 'M', 'LastName': 'Barbieri', 'Affiliation': 'University of Campania-Luigi Vanvitelli, Naples, Italy.'}, {'ForeName': 'Luz M', 'Initials': 'LM', 'LastName': 'Peña-Longobardo', 'Affiliation': 'University Castilla La Mancha University, Toledo, Spain.'}, {'ForeName': 'Sophie C', 'Initials': 'SC', 'LastName': 'Regueme', 'Affiliation': 'Centre Hospitalier Universitaire de Bordeaux, Bordeaux, France.'}, {'ForeName': 'Riccardo', 'Initials': 'R', 'LastName': 'Calvani', 'Affiliation': 'Università Cattolica Sacro Cuore, Rome, Italy.'}, {'ForeName': 'Stefanie', 'Initials': 'S', 'LastName': 'De Buyser', 'Affiliation': 'Department of Geriatrics, Ghent University Hospital, Ghent, Belgium.'}, {'ForeName': 'Alan J', 'Initials': 'AJ', 'LastName': 'Sinclair', 'Affiliation': 'Foundation for Diabetes Research in Older People, Diabetes Frail Ltd, Luton, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Journal of cachexia, sarcopenia and muscle",['10.1002/jcsm.12432'] 295,31138522,Randomized Double-Blind Placebo-Controlled Biomarker Modulation Study of Vitamin D Supplementation in Premenopausal Women at High Risk for Breast Cancer (SWOG S0812).,"Observational studies have reported an inverse association between vitamin D intake and breast cancer risk. We examined whether vitamin D supplementation in high-risk premenopausal women reduces mammographic density (MD), an established breast cancer risk factor. We conducted a multicenter randomized double-blind placebo-controlled trial in premenopausal women at high risk for breast cancer [5-year risk ≥ 1.67%, lifetime risk ≥ 20%, lobular carcinoma in situ , prior stage 0-II breast cancer, hereditary breast cancer syndrome, or high MD (heterogeneously/extremely dense)], with a baseline serum 25-hydroxyvitamin D [25(OH)D] ≤ 32 ng/mL. Participants were randomized to 12 months of vitamin D3 20,000 IU/week or matching placebo. The primary endpoint was change in MD from baseline to 12 months using the Cumulus technique. Secondary endpoints included serial blood biomarkers [25(OH)D, 1,25-dihydroxyvitamin D (1,25(OH)D), insulin-like growth factor (IGF)-1, IGF-binding protein-3] and MD change at 24 months. Among 208 women randomized, median age was 44.6 years, 84% were white, 33% had baseline 25(OH)D < 20 ng/mL, and 78% had high baseline MD. Comparing the active and placebo groups at 12 months, MD changes were small and did not significantly differ. Mean MD changes at 12 and 24 months were -0.3% and -1.2%, respectively, in the active arm and +1.5% and +1.6% with placebo ( P > 0.05). We observed a mean change in serum 25(OH)D of +18.9 versus +2.8 ng/mL ( P < 0.01) and IGF-1 of -9.8 versus -1.8 ng/mL ( P = 0.28), respectively. At 12 months, MD was positively correlated with serum IGF-1 and IGF-1/IGFBP-3 ( P < 0.01). This trial does not support the use of vitamin D supplementation for breast cancer risk reduction.",2019,"At 12 months, MD was positively correlated with serum IGF-1 and IGF-1/IGFBP-3 ( P < 0.01).","['Premenopausal Women at High Risk for Breast Cancer (SWOG S0812', 'high-risk premenopausal women reduces mammographic density (MD), an established breast cancer risk factor', 'premenopausal women at high risk for breast cancer [5-year risk ≥ 1.67%, lifetime risk ≥ 20%, lobular carcinoma in situ , prior stage 0-II', '208 women randomized, median age was 44.6 years, 84% were white, 33% had baseline 25(OH)D < 20 ng/mL, and 78% had high baseline MD']","['vitamin D supplementation', 'placebo', 'Placebo', 'Vitamin D Supplementation', 'vitamin D3 20,000 IU/week or matching placebo']","['mean change in serum 25(OH)D', 'Mean MD changes', 'serial blood biomarkers [25(OH)D, 1,25-dihydroxyvitamin D (1,25(OH)D), insulin-like growth factor (IGF)-1, IGF-binding protein-3] and MD change', 'MD changes', 'serum 25-hydroxyvitamin D [25(OH)D', 'IGF-1', 'serum IGF-1 and IGF-1/IGFBP-3', 'change in MD']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C4047809', 'cui_str': 'At high risk for breast cancer'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C1268717', 'cui_str': 'Mammographic Density'}, {'cui': 'C0443211', 'cui_str': 'Established (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C4517511', 'cui_str': 'One point six seven'}, {'cui': 'C0334381', 'cui_str': 'Lobular carcinoma in situ (morphologic abnormality)'}, {'cui': 'C0441763', 'cui_str': 'Stage 0 (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0439275', 'cui_str': 'ug/L'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]","[{'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3265062', 'cui_str': 'vitamin D3'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0005768'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0370232', 'cui_str': '1,25-dihydroxyvitamin D'}, {'cui': 'C0021665', 'cui_str': 'Somatomedin C'}, {'cui': 'C0123707', 'cui_str': 'IGF-Binding Protein 3'}, {'cui': 'C0535968', 'cui_str': '25-hydroxyvitamin D'}]",208.0,0.707928,"At 12 months, MD was positively correlated with serum IGF-1 and IGF-1/IGFBP-3 ( P < 0.01).","[{'ForeName': 'Katherine D', 'Initials': 'KD', 'LastName': 'Crew', 'Affiliation': 'Columbia University Irving Medical Center, New York, New York. kd59@cumc.columbia.edu.'}, {'ForeName': 'Garnet L', 'Initials': 'GL', 'LastName': 'Anderson', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Seattle, Washington.'}, {'ForeName': 'Dawn L', 'Initials': 'DL', 'LastName': 'Hershman', 'Affiliation': 'Columbia University Irving Medical Center, New York, New York.'}, {'ForeName': 'Mary Beth', 'Initials': 'MB', 'LastName': 'Terry', 'Affiliation': 'Columbia University Irving Medical Center, New York, New York.'}, {'ForeName': 'Parisa', 'Initials': 'P', 'LastName': 'Tehranifar', 'Affiliation': 'Columbia University Irving Medical Center, New York, New York.'}, {'ForeName': 'Danika L', 'Initials': 'DL', 'LastName': 'Lew', 'Affiliation': 'SWOG Statistics and Data Management Center, Seattle, Washington.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Yee', 'Affiliation': 'SWOG Statistics and Data Management Center, Seattle, Washington.'}, {'ForeName': 'Eric A', 'Initials': 'EA', 'LastName': 'Brown', 'Affiliation': 'William Beaumont Hospital, Beaumont NCORP, Troy, Michigan.'}, {'ForeName': 'Sebastien S', 'Initials': 'SS', 'LastName': 'Kairouz', 'Affiliation': 'Cancer Care Specialists of Central Illinois, Heartland NCORP, Decatur, Illinois.'}, {'ForeName': 'Nafisa', 'Initials': 'N', 'LastName': 'Kuwajerwala', 'Affiliation': 'William Beaumont Hospital, Beaumont NCORP, Troy, Michigan.'}, {'ForeName': 'Therese', 'Initials': 'T', 'LastName': 'Bevers', 'Affiliation': 'University of Texas, MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'John E', 'Initials': 'JE', 'LastName': 'Doster', 'Affiliation': 'Anderson Area Cancer Center, Southeast Clinical Oncology Research (SCOR) Consortium NCORP, Anderson, South Carolina.'}, {'ForeName': 'Corrine', 'Initials': 'C', 'LastName': 'Zarwan', 'Affiliation': 'Lahey Hospital and Medical Center, Burlington, Massachusetts.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Kruper', 'Affiliation': 'City of Hope Medical Center, Duarte, California.'}, {'ForeName': 'Lori M', 'Initials': 'LM', 'LastName': 'Minasian', 'Affiliation': 'Division of Cancer Prevention, National Cancer Institute, Bethesda, Maryland.'}, {'ForeName': 'Leslie', 'Initials': 'L', 'LastName': 'Ford', 'Affiliation': 'Division of Cancer Prevention, National Cancer Institute, Bethesda, Maryland.'}, {'ForeName': 'Banu', 'Initials': 'B', 'LastName': 'Arun', 'Affiliation': 'University of Texas, MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Marian', 'Initials': 'M', 'LastName': 'Neuhouser', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Seattle, Washington.'}, {'ForeName': 'Gary E', 'Initials': 'GE', 'LastName': 'Goodman', 'Affiliation': 'Swedish Cancer Institute, Pacific Cancer Research Consortium NCORP, Seattle, Washington.'}, {'ForeName': 'Powel H', 'Initials': 'PH', 'LastName': 'Brown', 'Affiliation': 'University of Texas, MD Anderson Cancer Center, Houston, Texas.'}]","Cancer prevention research (Philadelphia, Pa.)",['10.1158/1940-6207.CAPR-18-0444'] 296,31403327,Considering anticipated regret may reduce colorectal cancer screening intentions: a randomised controlled trial.,"Objective: Regular screening for colorectal cancer (CRC) can substantially improve outcomes. This study investigated how measuring regret expected from failing to screen might lead to stronger screening intentions. Five potential moderators were evaluated: perceived threat, psychological reactance, prior screening participation, concurrently measuring faecal aversion (FA) and anticipated regret (AR). Design: A 2 (AR measured pre/post intention) × 2 (FA measured pre/post intention) single blind parallel randomised controlled trial was used. Australians aged 45 and over completed an online survey measuring AR, FA, intention, theory of planned behaviour variables and potential moderators. Main outcome measures: The primary outcome was CRC screening intention. Results: Eight hundred and three participants were randomised, with 666 analysed. Measuring AR prior to intention unexpectedly resulted in a significantly lower intention to screen ( d  = 0.18, 95% CI [0.03, 0.33]) compared to measuring after intention. Trait reactance predicted a significantly lower intention when it was at least 0.52 SD above the mean; other moderators were not supported. Conclusion: The processes underlying anticipated regret manipulations must be better understood in order to have practical value in health promotion. More research is required to determine how to minimise or avoid the apparent negative effects of psychological reactance in CRC screening communication. Trial registration: Australian New Zealand Clinical Trials Registry: ACTRN12618001098224 http://www.ANZCTR.org.au/ACTRN12618001098224.aspx.",2020,Trait reactance predicted a significantly lower intention when it was at least 0.52 SD above the mean; other moderators were not supported. ,"['Eight hundred and three participants were randomised, with 666 analysed', 'colorectal cancer (CRC']",['Regular screening'],"['threat, psychological reactance, prior screening participation, concurrently measuring faecal aversion (FA) and anticipated regret (AR', 'colorectal cancer screening intentions', 'CRC screening intention', 'Trait reactance']","[{'cui': 'C3844106', 'cui_str': 'Eight hundred'}, {'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C0170127', 'cui_str': 'Calcibiotic Root Canal Sealer'}]","[{'cui': 'C0205272', 'cui_str': 'Regular (qualifier value)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}]","[{'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0233496', 'cui_str': 'Aversion (finding)'}, {'cui': 'C0080101', 'cui_str': 'Regret'}, {'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0170127', 'cui_str': 'Calcibiotic Root Canal Sealer'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}]",803.0,0.174368,Trait reactance predicted a significantly lower intention when it was at least 0.52 SD above the mean; other moderators were not supported. ,"[{'ForeName': 'Hugh', 'Initials': 'H', 'LastName': 'Hunkin', 'Affiliation': 'School of Psychology, University of Adelaide, Adelaide, SA, Australia.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Turnbull', 'Affiliation': 'School of Psychology, University of Adelaide, Adelaide, SA, Australia.'}, {'ForeName': 'Ian T', 'Initials': 'IT', 'LastName': 'Zajac', 'Affiliation': 'School of Psychology, University of Adelaide, Adelaide, SA, Australia.'}]",Psychology & health,['10.1080/08870446.2019.1649407'] 297,31135552,Small Social Incentives Did Not Improve the Survey Response Rate of Patients Who Underwent Orthopaedic Surgery: A Randomized Trial.,"BACKGROUND The generalizability of data derived from patient-reported outcome measures (PROMs) depends largely on the proportion of the relevant population that completes PROM surveys. However, PROM survey responses remain low, despite efforts to increase participation. Social incentives, such as the offer to make a charitable donation on behalf of the survey respondent, have generally not been effective where online surveys are concerned, but this has not been extensively tested in medicine. QUESTIONS/PURPOSES (1) Do personalized social incentives increase response rates or response completeness for postoperative PROM surveys in an orthopaedic population? (2) Are there demographic factors associated with response and nonresponse to postoperative PROM surveys? (3) Are some demographic factors associated with increased response to social incentive offers? METHODS Participants were selected from an institutional orthopaedics database. Patients were older than 18 years, had an email address on file, and had undergone one of the following procedures 1 to 2 years ago: Achilles tendon repair, ACL reconstruction, meniscectomy, hip arthroscopy, TKA, or THA. Of 4685 eligible patients, 3000 (64%) were randomly selected for inclusion in the study. Participants were randomized to one of four groups: (1) control: no incentive (n = 750); (2) patient donation: offer of a USD 5 donation to provide medical supplies to a pediatric orthopaedic patient (n = 751); (3) research donation: offer of a USD 5 donation to a procedure-specific research program (n = 749); or (4) explanation: explanation that response supports quality improvement (n = 750). The four groups did not differ regarding patient age, gender, race, procedure type, or time since procedure. All patients were sent an email invitation with the same PROM survey link. The proportion of patients who responded (defined here as the response rate) was measured at 4 weeks and compared between intervention groups. We used a logistic regression analysis to identify demographic factors associated with response while controlling for confounding variables and performed subgroup analyses to determine any demographic factors associated with increased response to social incentives. RESULTS There was no difference in the overall response rate (research donation: 49% [353 of 725], patient donation: 45% [333 of 734], control: 45% [322 of 723], explanation: 44% [314 of 719]; p = 0.239) or response completeness (research donation: 89% [315 of 353], patient donation: 90% [301 of 333], control: 89% [287 of 322], explanation: 87% [274 of 314]; p = 0.647) between the four groups. Women (odds ratio [OR], 1.175; p = 0.042), older patients (< 58 years: OR, 1.016 per 1-year increase; p = 0.001; 58-64 years: OR, 1.023 per 1-year increase; p < 0.001; > 64 years: OR, 1.021 per 1-year increase; p < 0.001), and white patients (OR 2.034 compared with black patients, p < 0.001) were slightly more likely to respond, after controlling for potential confounding variables such as gender, age, race, and procedure type. In subgroup analyses, men (research donation: 49% [155 of 316], patient donation: 45% [146 of 328], control: 40% [130 of 325], explanation: 39% [127 of 325]; p = 0.041) and patients younger than 58 years (research donation: 40% [140 of 351], control: 35% [130 of 371], patient donation: 32% [113 of 357], explanation: 27% [93 of 340]; p = 0.004) were slightly more likely to respond to the research donation than those with other interventions were. CONCLUSIONS Despite small effects in specific subgroups, personalized social incentives did not increase the overall response to postoperative orthopaedic surveys. Novel and targeted strategies will be necessary to reach response thresholds that enable healthcare stakeholders to use PROMs effectively. LEVEL OF EVIDENCE Level I, therapeutic study.",2019,"There was no difference in the overall response rate (research donation: 49% [353 of 725], patient donation: 45% [333 of 734], control: 45% [322 of 723], explanation: 44% [314 of 719]; p = 0.239) or response completeness (research donation: 89% [315 of 353], patient donation: 90% [301 of 333], control: 89% [287 of 322], explanation: 87% [274 of 314]; p = 0.647) between the four groups.","['4685 eligible patients, 3000 (64%) were randomly selected for inclusion in the study', 'Participants were selected from an institutional orthopaedics database', 'patients younger than 58 years (research donation: 40% [140 of 351], control: 35% [130 of 371], patient donation: 32% [113 of 357], explanation: 27% [93 of 340]; p = 0.004) were slightly more likely to respond to the research donation than those with other interventions were', 'All patients were sent an email invitation with the same PROM survey link', 'Patients were older than 18 years, had an email address on file, and had undergone one of the following procedures 1 to 2 years ago']","['Orthopaedic Surgery', 'USD 5 donation to a procedure-specific research program (n = 749); or (4) explanation: explanation that response supports quality improvement', 'control: no incentive (n = 750); (2) patient donation: offer of a USD 5 donation to provide medical supplies to a pediatric orthopaedic patient (n = 751); (3) research donation']","['Achilles tendon repair, ACL reconstruction, meniscectomy, hip arthroscopy, TKA, or THA', 'overall response rate', 'response rate', 'Survey Response Rate']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0470279', 'cui_str': 'Three thousand'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0035168'}, {'cui': 'C4049936', 'cui_str': 'Donation'}, {'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C4319552', 'cui_str': '130 (qualifier value)'}, {'cui': 'C4517730', 'cui_str': '340'}, {'cui': 'C0750482', 'cui_str': 'Slightly (qualifier value)'}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis (contextual qualifier) (qualifier value)'}, {'cui': 'C0013849', 'cui_str': 'Email'}, {'cui': 'C0015944', 'cui_str': 'Premature Rupture of Membrane (Pregnancy)'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0376649', 'cui_str': 'Address'}, {'cui': 'C0180853', 'cui_str': 'File, device (physical object)'}, {'cui': 'C0580203', 'cui_str': 'Postprocedural period (qualifier value)'}]","[{'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C4049936', 'cui_str': 'Donation'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0035168'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C2936612', 'cui_str': 'Quality Improvement'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C4517868', 'cui_str': '750 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C1875802', 'cui_str': 'Healthcare supplies'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}]","[{'cui': 'C0565350', 'cui_str': 'Repair of tendon (procedure)'}, {'cui': 'C0524865', 'cui_str': 'Reconstructive Surgery'}, {'cui': 'C0187901', 'cui_str': 'Meniscal Resection'}, {'cui': 'C0186190', 'cui_str': 'Arthroscopy of hip (procedure)'}, {'cui': 'C0642413', 'cui_str': 'THAS'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}]",4685.0,0.063268,"There was no difference in the overall response rate (research donation: 49% [353 of 725], patient donation: 45% [333 of 734], control: 45% [322 of 723], explanation: 44% [314 of 719]; p = 0.239) or response completeness (research donation: 89% [315 of 353], patient donation: 90% [301 of 333], control: 89% [287 of 322], explanation: 87% [274 of 314]; p = 0.647) between the four groups.","[{'ForeName': 'Hunter', 'Initials': 'H', 'LastName': 'Warwick', 'Affiliation': 'H. Warwick, C. Hutyra, C. Politzer, A. Francis, T. Risoli, Jr, C. Green, R. C. Mather III, Department of Orthopaedic Surgery, Duke University Medical Center, Durham, NC, USA N. Verma, Department of Orthopaedic Surgery, Rush University Medical Center, Chicago, IL, USA S. Huettel, Department of Psychology and Neuroscience, Duke University, Durham, NC, USA.'}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Hutyra', 'Affiliation': ''}, {'ForeName': 'Cary', 'Initials': 'C', 'LastName': 'Politzer', 'Affiliation': ''}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Francis', 'Affiliation': ''}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Risoli', 'Affiliation': ''}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Green', 'Affiliation': ''}, {'ForeName': 'Nikhil', 'Initials': 'N', 'LastName': 'Verma', 'Affiliation': ''}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Huettel', 'Affiliation': ''}, {'ForeName': 'Richard C', 'Initials': 'RC', 'LastName': 'Mather', 'Affiliation': ''}]",Clinical orthopaedics and related research,['10.1097/CORR.0000000000000732'] 298,31587565,High-Sensitivity Cardiac Troponin and the Universal Definition of Myocardial Infarction.,"BACKGROUND The introduction of more sensitive cardiac troponin assays has led to increased recognition of myocardial injury in acute illnesses other than acute coronary syndrome. The Universal Definition of Myocardial Infarction recommends high-sensitivity cardiac troponin testing and classification of patients with myocardial injury based on pathogenesis, but the clinical implications of implementing this guideline are not well understood. METHODS In a stepped-wedge cluster randomized, controlled trial, we implemented a high-sensitivity cardiac troponin assay and the recommendations of the Universal Definition in 48 282 consecutive patients with suspected acute coronary syndrome. In a prespecified secondary analysis, we compared the primary outcome of myocardial infarction or cardiovascular death and secondary outcome of noncardiovascular death at 1 year across diagnostic categories. RESULTS Implementation increased the diagnosis of type 1 myocardial infarction by 11% (510/4471), type 2 myocardial infarction by 22% (205/916), and acute and chronic myocardial injury by 36% (443/1233) and 43% (389/898), respectively. Compared with those without myocardial injury, the rate of the primary outcome was highest in those with type 1 myocardial infarction (cause-specific hazard ratio [HR] 5.64 [95% CI, 5.12-6.22]), but was similar across diagnostic categories, whereas noncardiovascular deaths were highest in those with acute myocardial injury (cause specific HR 2.65 [95% CI, 2.33-3.01]). Despite modest increases in antiplatelet therapy and coronary revascularization after implementation in patients with type 1 myocardial infarction, the primary outcome was unchanged (cause specific HR 1.00 [95% CI, 0.82-1.21]). Increased recognition of type 2 myocardial infarction and myocardial injury did not lead to changes in investigation, treatment or outcomes. CONCLUSIONS Implementation of high-sensitivity cardiac troponin assays and the recommendations of the Universal Definition of Myocardial Infarction identified patients at high-risk of cardiovascular and noncardiovascular events but was not associated with consistent increases in treatment or improved outcomes. Trials of secondary prevention are urgently required to determine whether this risk is modifiable in patients without type 1 myocardial infarction. CLINICAL TRIAL REGISTRATION https://www.clinicaltrials.gov. Unique identifier: NCT01852123.",2020,"Implementation increased the diagnosis of type 1 myocardial infarction by 11% (510/4,471), type 2 myocardial infarction by 22% (205/916), and acute and chronic myocardial injury by 36% (443/1,233) and 43% (389/898), respectively.","['patients with type 1 myocardial infarction', 'patients without type 1 myocardial infarction', '48,282 consecutive patients with suspected acute coronary syndrome', 'patients with myocardial injury']",[],"['myocardial infarction or cardiovascular death and secondary outcome of non-cardiovascular death at one year across diagnostic categories', 'non-cardiovascular deaths', 'type 2 myocardial infarction', 'diagnosis of type 1 myocardial infarction', 'myocardial infarction (cause-specific hazard ratio [csHR', 'acute and chronic myocardial injury', 'anti-platelet therapy and coronary revascularization']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0441729', 'cui_str': 'Type 1 (qualifier value)'}, {'cui': 'C0750491', 'cui_str': 'Suspected (qualifier value)'}, {'cui': 'C0948089', 'cui_str': 'Acute Coronary Syndrome'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}]",[],"[{'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C0348026', 'cui_str': 'Diagnostic'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0441729', 'cui_str': 'Type 1 (qualifier value)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0005821', 'cui_str': 'Platelets'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0877341', 'cui_str': 'Coronary revascularisation'}]",,0.358692,"Implementation increased the diagnosis of type 1 myocardial infarction by 11% (510/4,471), type 2 myocardial infarction by 22% (205/916), and acute and chronic myocardial injury by 36% (443/1,233) and 43% (389/898), respectively.","[{'ForeName': 'Andrew R', 'Initials': 'AR', 'LastName': 'Chapman', 'Affiliation': 'BHF Centre for Cardiovascular Science (A.R.C., P.D.A., A.S.V.S., A.A., F.E.S., A.V.F., K.K.L., K.A.A.F., D.E.N., N.L.M.), University of Edinburgh, United Kingdom.'}, {'ForeName': 'Philip D', 'Initials': 'PD', 'LastName': 'Adamson', 'Affiliation': 'BHF Centre for Cardiovascular Science (A.R.C., P.D.A., A.S.V.S., A.A., F.E.S., A.V.F., K.K.L., K.A.A.F., D.E.N., N.L.M.), University of Edinburgh, United Kingdom.'}, {'ForeName': 'Anoop S V', 'Initials': 'ASV', 'LastName': 'Shah', 'Affiliation': 'BHF Centre for Cardiovascular Science (A.R.C., P.D.A., A.S.V.S., A.A., F.E.S., A.V.F., K.K.L., K.A.A.F., D.E.N., N.L.M.), University of Edinburgh, United Kingdom.'}, {'ForeName': 'Atul', 'Initials': 'A', 'LastName': 'Anand', 'Affiliation': 'BHF Centre for Cardiovascular Science (A.R.C., P.D.A., A.S.V.S., A.A., F.E.S., A.V.F., K.K.L., K.A.A.F., D.E.N., N.L.M.), University of Edinburgh, United Kingdom.'}, {'ForeName': 'Fiona E', 'Initials': 'FE', 'LastName': 'Strachan', 'Affiliation': 'BHF Centre for Cardiovascular Science (A.R.C., P.D.A., A.S.V.S., A.A., F.E.S., A.V.F., K.K.L., K.A.A.F., D.E.N., N.L.M.), University of Edinburgh, United Kingdom.'}, {'ForeName': 'Amy V', 'Initials': 'AV', 'LastName': 'Ferry', 'Affiliation': 'BHF Centre for Cardiovascular Science (A.R.C., P.D.A., A.S.V.S., A.A., F.E.S., A.V.F., K.K.L., K.A.A.F., D.E.N., N.L.M.), University of Edinburgh, United Kingdom.'}, {'ForeName': 'Kuan', 'Initials': 'K', 'LastName': 'Ken Lee', 'Affiliation': 'BHF Centre for Cardiovascular Science (A.R.C., P.D.A., A.S.V.S., A.A., F.E.S., A.V.F., K.K.L., K.A.A.F., D.E.N., N.L.M.), University of Edinburgh, United Kingdom.'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'Berry', 'Affiliation': 'Institute of Cardiovascular and Medical Sciences (C.B.), University of Glasgow, United Kingdom.'}, {'ForeName': 'Iain', 'Initials': 'I', 'LastName': 'Findlay', 'Affiliation': 'Department of Cardiology, Royal Alexandra Hospital, Paisley, United Kingdom (I.F.).'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Cruikshank', 'Affiliation': 'Department of Biochemistry, Queen Elizabeth University Hospital, Glasgow, United Kingdom (A.C., A.R.).'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Reid', 'Affiliation': 'Department of Biochemistry, Queen Elizabeth University Hospital, Glasgow, United Kingdom (A.C., A.R.).'}, {'ForeName': 'Alasdair', 'Initials': 'A', 'LastName': 'Gray', 'Affiliation': 'Emergency Medicine Research Group Edinburgh, Royal Infirmary of Edinburgh, United Kingdom (A.G.).'}, {'ForeName': 'Paul O', 'Initials': 'PO', 'LastName': 'Collinson', 'Affiliation': ""Departments of Clinical Blood Sciences and Cardiology, St George's, University Hospitals NHS Trust and St George's University of London, United Kingdom (P.O.C.).""}, {'ForeName': 'Fred', 'Initials': 'F', 'LastName': 'Apple', 'Affiliation': 'Department of Laboratory Medicine and Pathology, Hennepin Healthcare/Hennepin County Medical Center & University of Minnesota, Minneapolis (F.A.).'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'McAllister', 'Affiliation': 'Institute of Health and Wellbeing (D.A.McA.), University of Glasgow, United Kingdom.'}, {'ForeName': 'Donogh', 'Initials': 'D', 'LastName': 'Maguire', 'Affiliation': 'Emergency Medicine Department, Glasgow Royal Infirmary, United Kingdom (D.M).'}, {'ForeName': 'Keith A A', 'Initials': 'KAA', 'LastName': 'Fox', 'Affiliation': 'BHF Centre for Cardiovascular Science (A.R.C., P.D.A., A.S.V.S., A.A., F.E.S., A.V.F., K.K.L., K.A.A.F., D.E.N., N.L.M.), University of Edinburgh, United Kingdom.'}, {'ForeName': 'Catalina A', 'Initials': 'CA', 'LastName': 'Vallejos', 'Affiliation': 'MRC Human Genetics Unit (C.A.V.), University of Edinburgh, United Kingdom.'}, {'ForeName': 'Catriona', 'Initials': 'C', 'LastName': 'Keerie', 'Affiliation': 'Edinburgh Clinical Trials Unit (C.K., C.J.W.), University of Edinburgh, United Kingdom.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Weir', 'Affiliation': 'Edinburgh Clinical Trials Unit (C.K., C.J.W.), University of Edinburgh, United Kingdom.'}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Newby', 'Affiliation': 'BHF Centre for Cardiovascular Science (A.R.C., P.D.A., A.S.V.S., A.A., F.E.S., A.V.F., K.K.L., K.A.A.F., D.E.N., N.L.M.), University of Edinburgh, United Kingdom.'}, {'ForeName': 'Nicholas L', 'Initials': 'NL', 'LastName': 'Mills', 'Affiliation': 'BHF Centre for Cardiovascular Science (A.R.C., P.D.A., A.S.V.S., A.A., F.E.S., A.V.F., K.K.L., K.A.A.F., D.E.N., N.L.M.), University of Edinburgh, United Kingdom.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Circulation,['10.1161/CIRCULATIONAHA.119.042960'] 299,31606589,Effect of lofexidine on cardiac repolarization during treatment of opioid withdrawal.,"BACKGROUND Lofexidine is a non-opioid treatment for opioid withdrawal syndrome. Its sympatholytic actions counteract the nor-adrenergic hyperactivity that occurs during abrupt opioid withdrawal. METHODS The effect of lofexidine 2.16 and 2.88 mg/day on QTcF (QT interval, heart-rate corrected, Fridericia formula) was studied as part of a large, double-blind, placebo-controlled trial (ClinicalTrials.gov identifier: NCT01863186). ECGs were time-matched to blood sampling for lofexidine concentration and were collected at prespecified timepoints over a 7-day inpatient period. Analyses included mean change-from-baseline QTcF and exposure-response modeling to predict QTcF at relevant lofexidine concentrations. RESULTS A total of 681 adult men and women received at least 1 dose of study drug; 566 qualified for inclusion in the concentration-QTcF analysis. Most subjects were withdrawing from heroin. During the first 24 h (Days 1-2) post-baseline, small increases in QTcF were observed in all groups: 4.7 ms for lofexidine 2.16 mg, 7.4 ms for lofexidine 2.88 mg and 1.4 ms for placebo. These increases were transient; by Day 4, when lofexidine levels had reached steady-state, QTcF increases were not present. By Day 7, QTcF was decreased from baseline in all groups. Exposure-response modeling predicted <10 ms increases in QTcF at lofexidine concentrations 3 times those obtained at maximal recommended dose. CONCLUSIONS Lofexidine was associated with small, transient QTcF increases. Decreases in QTcF that occurred with higher lofexidine concentrations argue for an indirect QTcF effect, potentially from changes in autonomic tone. Both opioid withdrawal and lofexidine's sympatholytic actions would be expected to alter sympathetic outflow over the 7-day withdrawal.",2019,"The effect of lofexidine 2.16 and 2.88 mg/day on QTcF (QT interval, heart-rate corrected, Fridericia formula) was studied as part of a large, double-blind, placebo-controlled trial (ClinicalTrials.gov identifier: NCT01863186).",['681 adult men and women received at least 1 dose of study drug; 566 qualified for inclusion in the concentration-QTcF analysis'],"['Lofexidine', 'placebo', ""lofexidine's sympatholytic actions"", 'lofexidine']","['cardiac repolarization', 'autonomic tone', 'QTcF', 'QTcF (QT interval, heart-rate corrected, Fridericia formula', 'sympathetic outflow']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1524024', 'cui_str': 'analysis'}]","[{'cui': 'C0065152', 'cui_str': 'lofexidine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0039051', 'cui_str': 'Sympatholytic Agents'}, {'cui': 'C0441472', 'cui_str': 'Action (qualifier value)'}]","[{'cui': 'C0429028', 'cui_str': 'QT interval feature'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}]",681.0,0.161758,"The effect of lofexidine 2.16 and 2.88 mg/day on QTcF (QT interval, heart-rate corrected, Fridericia formula) was studied as part of a large, double-blind, placebo-controlled trial (ClinicalTrials.gov identifier: NCT01863186).","[{'ForeName': 'Börje', 'Initials': 'B', 'LastName': 'Darpö', 'Affiliation': ""Department of Clinical Sciences, Karolinska Institute, Danderyd's Hospital, 182 88 Stockholm, Sweden. Electronic address: borje.darpo@telia.com.""}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Pirner', 'Affiliation': 'Department of Clinical Research and Medical Affairs, US WorldMeds, LLC, 4441 Springdale Rd, Louisville, KY 40241, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Longstreth', 'Affiliation': 'Longstreth and Associates, Inc., 450 N Lakeshore Dr, Mundelein, IL 60060, USA.'}, {'ForeName': 'Georg', 'Initials': 'G', 'LastName': 'Ferber', 'Affiliation': 'Statistik Georg Ferber GmbH, Cagliostrostrasse 14, 4125 Riehen, Switzerland.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2019.107596'] 300,30733088,"Parent report of provider HPV vaccine communication strategies used during a randomized, controlled trial of a provider communication intervention.","OBJECTIVE To assess secondary, parent-reported outcomes from a randomized controlled trial (RCT) of a provider communication intervention aimed at improving adolescent HPV vaccination. METHODS A paper survey was provided to a random sample of 777 parents of adolescents from 8 control and 8 intervention clinics participating in the larger trial. Chi-square or Fisher's exact tests assessed associations between study arm and providers' HPV vaccine communication strategies, parents' vaccination attitudes and parent's HPV vaccine acceptance. Exploratory analyses assessed the association between receipt of 'very strong' or presumptive HPV vaccine recommendation (regardless of study arm) and parent's perceptions about their providers' vaccine communication, and parents' attitudes and acceptance of the HPV vaccine. RESULTS The response rate was 47%. There were no differences between study arms in parents' report of how their provider communicated about the HPV vaccine, parent vaccination attitudes, or uptake of the HPV vaccine. Receipt of a 'very strong' recommendation was associated with greater perceived urgency for getting vaccinated, greater trust in the information received from the provider, decreased vaccine hesitancy, and increased vaccine receipt. Receipt of a presumptive recommendation was associated with a lower likelihood of having concerns about the vaccine's safety, lower vaccine hesitancy, and an increased likelihood of vaccination. Neither recommendation strategy appeared to negatively impact parents' visit experience or trust in the information being provided. Similar results were found in sub-analyses of vaccine hesitant parents. CONCLUSIONS Providing very strong, presumptive HPV vaccine recommendations is associated with improved parent vaccination attitudes and acceptance, and does not seem to have significant negative impacts, even among parents who are vaccine hesitant. Response bias in our sample could explain why there were no reported differences between study arms in parents' reports of how their adolescent's providers communicated about the HPV vaccine.",2019,"There were no differences between study arms in parents' report of how their provider communicated about the HPV vaccine, parent vaccination attitudes, or uptake of the HPV vaccine.",['777 parents of adolescents from 8 control and 8 intervention clinics participating in the larger trial'],"['provider HPV vaccine communication strategies', 'provider communication intervention']","['HPV vaccine, parent vaccination attitudes, or uptake of the HPV vaccine', 'response rate']","[{'cui': 'C0030551', 'cui_str': 'Parent of (observable entity)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}]","[{'cui': 'C1512511', 'cui_str': 'HPV Vaccines'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C1274143', 'cui_str': 'Communication treatments and procedures'}]","[{'cui': 'C1512511', 'cui_str': 'HPV Vaccines'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}]",777.0,0.10398,"There were no differences between study arms in parents' report of how their provider communicated about the HPV vaccine, parent vaccination attitudes, or uptake of the HPV vaccine.","[{'ForeName': 'A F', 'Initials': 'AF', 'LastName': 'Dempsey', 'Affiliation': 'Adult and Child Consortium for Outcomes Research and Delivery Science (ACCORDS), University of Colorado Denver, United States. Electronic address: Amanda.dempsey@ucdenver.edu.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Pyrzanowski', 'Affiliation': 'Adult and Child Consortium for Outcomes Research and Delivery Science (ACCORDS), University of Colorado Denver, United States.'}, {'ForeName': 'E J', 'Initials': 'EJ', 'LastName': 'Campagna', 'Affiliation': 'Adult and Child Consortium for Outcomes Research and Delivery Science (ACCORDS), University of Colorado Denver, United States.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Lockhart', 'Affiliation': 'Adult and Child Consortium for Outcomes Research and Delivery Science (ACCORDS), University of Colorado Denver, United States.'}, {'ForeName': 'S T', 'Initials': 'ST', 'LastName': ""O'Leary"", 'Affiliation': 'Adult and Child Consortium for Outcomes Research and Delivery Science (ACCORDS), University of Colorado Denver, United States.'}]",Vaccine,['10.1016/j.vaccine.2019.01.051'] 301,31021123,Identifying pathways to quitting smoking via telemedicine-delivered care.,"OBJECTIVE A randomized controlled trial of quitline-like phone counseling (QL) versus telemedicine integrated into primary care (ITM) compared the effectiveness of these modalities for smoking cessation. Study design and components were based on self-determination theory (SDT). The purpose of this study was to test our SDT-based model in which perceived health care provider autonomy support, working alliance, autonomous motivation, and perceived competence were hypothesized to mediate the effects of ITM on smoking cessation. METHOD Rural smokers ( n = 560) were randomized to receive 4 sessions over a 3-month period of either QL or ITM. Follow-up assessments were conducted at Months 3, 6, and 12. The primary outcome was biochemically verified 7-day point prevalence at 12 -months. Structural equation modeling with latent change scores was used for the analysis. RESULTS Participants in the ITM condition reported greater increases in perceived health care provider autonomy support (PAS) at end of treatment, which in turn was associated with enhanced perceived competence to quit smoking (PC). Increased PC was associated with a higher likelihood of cessation at 12-months. Mediation analysis demonstrated significant indirect effects, including a path from ITM to increases in PAS to increases in PC to cessation at 12-months (indirect effect = 0.0183, 95% confidence interval [.003, .0434]). CONCLUSIONS When integrated into primary care, ITM may influence smoking cessation by enhancing the extent to which smokers feel supported by their providers and thereby increase their perceived ability to quit. Findings suggest that locating tobacco treatment services in health care provider offices imparts a motivational benefit for cessation. (PsycINFO Database Record (c) 2019 APA, all rights reserved).",2019,"Mediation analysis demonstrated significant indirect effects, including a path from ITM to increases in PAS to increases in PC to cessation at 12-months (indirect effect = 0.0183, 95% confidence interval [.003, .0434]). ",['Rural smokers ( n = 560'],"['QL or ITM', 'quitline-like phone counseling (QL) versus telemedicine integrated into primary care (ITM']","['7-day point prevalence at 12 -months', 'enhanced perceived competence to quit smoking (PC', 'PAS', 'perceived health care provider autonomy support (PAS']","[{'cui': 'C0337664', 'cui_str': 'Smoker'}]","[{'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}]","[{'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C0018724', 'cui_str': 'Healthcare Workers'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}]",560.0,0.0494606,"Mediation analysis demonstrated significant indirect effects, including a path from ITM to increases in PAS to increases in PC to cessation at 12-months (indirect effect = 0.0183, 95% confidence interval [.003, .0434]). ","[{'ForeName': 'Edward P', 'Initials': 'EP', 'LastName': 'Liebmann', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Kristopher J', 'Initials': 'KJ', 'LastName': 'Preacher', 'Affiliation': 'Department of Psychology & Human Development.'}, {'ForeName': 'Kimber P', 'Initials': 'KP', 'LastName': 'Richter', 'Affiliation': 'Department of Public Health & Preventive Medicine.'}, {'ForeName': 'A Paula', 'Initials': 'AP', 'LastName': 'Cupertino', 'Affiliation': 'Cancer Prevention & Control Program.'}, {'ForeName': 'Delwyn', 'Initials': 'D', 'LastName': 'Catley', 'Affiliation': ""Children's Mercy Hospital.""}]","Health psychology : official journal of the Division of Health Psychology, American Psychological Association",['10.1037/hea0000740'] 302,32145111,c-MYC expression and maturity phenotypes are associated with outcome benefit from addition of ixazomib to lenalidomide-dexamethasone in myeloma.,"OBJECTIVES In the TOURMALINE-MM1 phase 3 trial in relapsed/refractory multiple myeloma, ixazomib-lenalidomide-dexamethasone (IRd) showed different magnitudes of progression-free survival (PFS) benefit vs placebo-Rd according to number and type of prior therapies, with greater benefit seen in patients with >1 prior line of therapy or 1 prior line of therapy without stem cell transplantation (SCT). METHODS RNA sequencing data were used to investigate the basis of these differences. RESULTS The PFS benefit of IRd vs placebo-Rd was greater in patients with tumors expressing high c-MYC levels (median not reached vs 11.3 months; hazard ratio [HR] 0.42; 95% CI, 0.26, 0.66; P < .001) compared with in those expressing low c-MYC levels (median 20.6 vs 16.6 months; HR 0.75; 95% CI, 0.42, 1.2). Expression of c-MYC in tumors varied based on the number and type of prior therapy received, with the lowest levels observed in tumors of patients who had received 1 prior line of therapy including SCT. These tumors also had higher expression levels of CD19 and CD81. CONCLUSIONS PFS analyses suggest that lenalidomide and ixazomib target tumors with different levels of c-MYC, CD19, and CD81 expression, thus providing a potential rationale for the differential benefits observed in the TOURMALINE-MM1 study. This trial was registered at www.clinicaltrials.gov as: NCT01564537.",2020,"Expression of c-MYC in tumors varied based on the number and type of prior therapy received, with the lowest levels observed in tumors of patients who had received 1 prior line of therapy including SCT.",['patients with >1 prior line of therapy or 1 prior line of therapy without stem cell transplantation (SCT'],[],[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4280965', 'cui_str': '>1'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1504389', 'cui_str': 'Stem Cell Transplantation'}]",[],[],,0.125194,"Expression of c-MYC in tumors varied based on the number and type of prior therapy received, with the lowest levels observed in tumors of patients who had received 1 prior line of therapy including SCT.","[{'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Di Bacco', 'Affiliation': 'Millennium Pharmaceuticals, Inc. (a wholly owned subsidiary of Takeda Pharmaceutical Company Limited), Cambridge, MA, USA.'}, {'ForeName': 'Nizar J', 'Initials': 'NJ', 'LastName': 'Bahlis', 'Affiliation': 'Southern Alberta Cancer Research Institute, University of Calgary, Calgary, AB, Canada.'}, {'ForeName': 'Nikhil C', 'Initials': 'NC', 'LastName': 'Munshi', 'Affiliation': 'Hematologic Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.'}, {'ForeName': 'Hervé', 'Initials': 'H', 'LastName': 'Avet-Loiseau', 'Affiliation': 'Hematology, IUC-Oncopole, Toulouse, France.'}, {'ForeName': 'Tamás', 'Initials': 'T', 'LastName': 'Masszi', 'Affiliation': 'Department of Haematology and Stem Cell Transplantation, St. István and St. László Hospital of Budapest, Budapest, Hungary.'}, {'ForeName': 'Luísa', 'Initials': 'L', 'LastName': 'Viterbo', 'Affiliation': 'Instituto Português de Oncologia do Porto Francisco Gentil, Entidade Pública Empresarial (IPOPFG, EPE), Porto, Portugal.'}, {'ForeName': 'Ludek', 'Initials': 'L', 'LastName': 'Pour', 'Affiliation': 'Hematology and Oncology, University Hospital Brno, Brno, Czech Republic.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Ganly', 'Affiliation': 'Department of Haematology, Christchurch Hospital, Christchurch, New Zealand.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Cavo', 'Affiliation': 'Institute of Hematology and Medical Oncology ""Seràgnoli"", Bologna University School of Medicine, S.Orsola\'s University Hospital, Bologna, Italy.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Langer', 'Affiliation': 'University Hospital of Ulm, Ulm, Germany.'}, {'ForeName': 'Shaji K', 'Initials': 'SK', 'LastName': 'Kumar', 'Affiliation': 'Division of Hematology, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'S Vincent', 'Initials': 'SV', 'LastName': 'Rajkumar', 'Affiliation': 'Division of Hematology, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Jonathan J', 'Initials': 'JJ', 'LastName': 'Keats', 'Affiliation': 'Translational Genomics Research Institute (TGEN), Phoenix, AZ, USA.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Berg', 'Affiliation': 'Millennium Pharmaceuticals, Inc. (a wholly owned subsidiary of Takeda Pharmaceutical Company Limited), Cambridge, MA, USA.'}, {'ForeName': 'Jianchang', 'Initials': 'J', 'LastName': 'Lin', 'Affiliation': 'Millennium Pharmaceuticals, Inc. (a wholly owned subsidiary of Takeda Pharmaceutical Company Limited), Cambridge, MA, USA.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Li', 'Affiliation': 'Millennium Pharmaceuticals, Inc. (a wholly owned subsidiary of Takeda Pharmaceutical Company Limited), Cambridge, MA, USA.'}, {'ForeName': 'Sunita', 'Initials': 'S', 'LastName': 'Badola', 'Affiliation': 'Millennium Pharmaceuticals, Inc. (a wholly owned subsidiary of Takeda Pharmaceutical Company Limited), Cambridge, MA, USA.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Shen', 'Affiliation': 'Millennium Pharmaceuticals, Inc. (a wholly owned subsidiary of Takeda Pharmaceutical Company Limited), Cambridge, MA, USA.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Millennium Pharmaceuticals, Inc. (a wholly owned subsidiary of Takeda Pharmaceutical Company Limited), Cambridge, MA, USA.'}, {'ForeName': 'Dixie-Lee', 'Initials': 'DL', 'LastName': 'Esseltine', 'Affiliation': 'Millennium Pharmaceuticals, Inc. (a wholly owned subsidiary of Takeda Pharmaceutical Company Limited), Cambridge, MA, USA.'}, {'ForeName': 'Katarina', 'Initials': 'K', 'LastName': 'Luptakova', 'Affiliation': 'Millennium Pharmaceuticals, Inc. (a wholly owned subsidiary of Takeda Pharmaceutical Company Limited), Cambridge, MA, USA.'}, {'ForeName': 'Helgi', 'Initials': 'H', 'LastName': 'van de Velde', 'Affiliation': 'Millennium Pharmaceuticals, Inc. (a wholly owned subsidiary of Takeda Pharmaceutical Company Limited), Cambridge, MA, USA.'}, {'ForeName': 'Paul G', 'Initials': 'PG', 'LastName': 'Richardson', 'Affiliation': 'Hematologic Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Moreau', 'Affiliation': 'Department of Hematology, University Hospital Hôtel Dieu, University of Nantes, Nantes, France.'}]",European journal of haematology,['10.1111/ejh.13405'] 303,30797638,"Efficacy, safety, and immunogenicity of a quadrivalent HPV vaccine in Japanese men: A randomized, Phase 3, placebo-controlled study.","BACKGROUND The quadrivalent (q) human papillomavirus (HPV) vaccine protects against infection and disease related to HPV types 6, 11, 16, and 18. We report efficacy, immunogenicity, and safety of qHPV vaccine in a Phase 3 study in Japanese men. METHODS In this randomized, double-blind trial (NCT01862874), Japanese men (aged 16-26 years) were randomized in a 1:1 ratio to receive three doses of qHPV vaccine or placebo (Day 1, Month 2, Month 6). The primary efficacy endpoint was the combined incidence of HPV6/11/16/18-related persistent anogenital infection (detected at ≥2 consecutive visits ≥6 months apart), assessed in the per-protocol population of men who received all three vaccinations, and were seronegative at Day 1 and PCR negative from Day 1 to Month 7 to the relevant HPV type. Results are from the interim and final analyses. RESULTS In total, 1124 participants were randomized. The vaccine demonstrated 83.3% (95% confidence interval: 24.9, 98.2; p = 0.007) and 85.9% (95% confidence interval: 52.7, 97.3; p < 0.001) efficacy against HPV6/11/16/18-related persistent infection in the interim and final analyses, respectively. Two cases of HPV6/11/16/18-related external genital lesions (condyloma and PIN 1) were observed in the placebo group and none in the qHPV vaccine group at study end. At Month 7, >97% of participants who received qHPV vaccine seroconverted to each of the vaccine HPV types. Most participants remained seropositive at Month 36, although the seropositivity rate declined between Months 7 and 36. Vaccination-related adverse events were reported in 60.8% and 56.5% of participants in the qHPV vaccine and placebo groups, respectively; most commonly mild to moderate injection-site pain, erythema, and swelling. Injection-site pain and swelling were more common with qHPV vaccine than placebo (each p < 0.05). CONCLUSIONS Results suggest qHPV vaccine is efficacious against HPV6/11/16/18-related persistent infections, immunogenic, and well-tolerated in Japanese men. Clinical trial registration identifier: NCT01862874.",2019,"Injection-site pain and swelling were more common with qHPV vaccine than placebo (each p < 0.05). ","['Japanese men', 'Japanese men (aged 16-26\u202fyears', '1124 participants were randomized']","['placebo', 'qHPV vaccine or placebo', 'qHPV vaccine', 'quadrivalent (q) human papillomavirus (HPV) vaccine', 'quadrivalent HPV vaccine']","['combined incidence of HPV6/11/16/18-related persistent anogenital infection', 'seropositivity rate', 'Vaccination-related adverse events', 'moderate injection-site pain, erythema, and swelling', 'Injection-site pain and swelling', 'Efficacy, safety, and immunogenicity']","[{'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C1512511', 'cui_str': 'HPV Vaccines'}]","[{'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0151828', 'cui_str': 'Injection site pain (disorder)'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0038999', 'cui_str': 'Bulging (morphologic abnormality)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",1124.0,0.63454,"Injection-site pain and swelling were more common with qHPV vaccine than placebo (each p < 0.05). ","[{'ForeName': 'Hiroshige', 'Initials': 'H', 'LastName': 'Mikamo', 'Affiliation': 'Aichi Medical University Hospital, Nagakute, Japan.'}, {'ForeName': 'Yuka', 'Initials': 'Y', 'LastName': 'Yamagishi', 'Affiliation': 'Aichi Medical University Hospital, Nagakute, Japan.'}, {'ForeName': 'Shinya', 'Initials': 'S', 'LastName': 'Murata', 'Affiliation': 'MSD K.K., Tokyo, Japan. Electronic address: shinya.murata@merck.com.'}, {'ForeName': 'Ruriko', 'Initials': 'R', 'LastName': 'Yokokawa', 'Affiliation': 'MSD K.K., Tokyo, Japan.'}, {'ForeName': 'Shi Rong', 'Initials': 'SR', 'LastName': 'Han', 'Affiliation': 'MSD K.K., Tokyo, Japan.'}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Wakana', 'Affiliation': 'MSD K.K., Tokyo, Japan.'}, {'ForeName': 'Miyuki', 'Initials': 'M', 'LastName': 'Sawata', 'Affiliation': 'MSD K.K., Tokyo, Japan.'}, {'ForeName': 'Yoshiyuki', 'Initials': 'Y', 'LastName': 'Tanaka', 'Affiliation': 'MSD K.K., Tokyo, Japan.'}]",Vaccine,['10.1016/j.vaccine.2019.01.069'] 304,32087337,N-acetylcysteine for the treatment of comorbid alcohol use disorder and posttraumatic stress disorder: Design and methodology of a randomized clinical trial.,"Alcohol use disorder (AUD) and posttraumatic stress disorder (PTSD) are two prevalent psychiatric conditions in the U.S. The co-occurrence of AUD and PTSD is also common, and associated with a more severe clinical presentation and worse treatment outcomes across the biopsychosocial spectrum (e.g., social and vocational functioning, physical health) as compared to either disorder alone. Despite the high co-occurrence and negative outcomes, research on effective medications for AUD/PTSD is sparse and there is little empirical evidence to guide treatment decisions. The study described in this paper addresses this knowledge gap by testing the efficacy of N-acetylcysteine (NAC) in reducing alcohol use and PTSD symptoms. Animal studies and prior clinical research suggest a role for NAC in the treatment of substance use disorders and PTSD via glutamate modulation. NAC is a cysteine pro-drug that stimulates the cystine-glutamate exchanger, normalizes glial glutamate transporters, and restores glutamatergic tone on presynaptic receptors in reward regions of the brain. Moreover, NAC is available over-the-counter, has a long-established safety record, and does not require titration to achieve the target dose. This paper describes the rationale, study design, and methodology of a 12-week, randomized, double-blind, placebo-controlled trial of NAC (2400 mg/day) among adults with co-occurring AUD and PTSD. Functional magnetic resonance imaging (fMRI) and proton magnetic resonance spectroscopy ( 1 H-MRS) are utilized to investigate the neural circuitry and neurochemistry underlying comorbid AUD/PTSD and identify predictors of treatment outcome. This study is designed to determine the efficacy of NAC in the treatment of co-occurring AUD/PTSD and provide new information regarding mechanisms of action implicated in co-occurring AUD/PTSD.",2020,Animal studies and prior clinical research suggest a role for NAC in the treatment of substance use disorders and PTSD via glutamate modulation.,"['adults with co-occurring AUD and PTSD', 'comorbid alcohol use disorder and posttraumatic stress disorder']","['placebo', 'NAC', 'N-acetylcysteine', 'Functional magnetic resonance imaging (fMRI) and proton magnetic resonance spectroscopy ( 1 H-MRS', 'N-acetylcysteine (NAC']",['alcohol use and PTSD symptoms'],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0001956', 'cui_str': 'Alcohol Use Disorder'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0001047', 'cui_str': 'Acetylcysteine'}, {'cui': 'C0376335', 'cui_str': 'fMRI'}, {'cui': 'C3850002', 'cui_str': '1H-MRS'}, {'cui': 'C0700308', 'cui_str': 'Protium (substance)'}]","[{'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",,0.0324161,Animal studies and prior clinical research suggest a role for NAC in the treatment of substance use disorders and PTSD via glutamate modulation.,"[{'ForeName': 'Sudie E', 'Initials': 'SE', 'LastName': 'Back', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, USA; Ralph H. Johnson Veterans Affairs Medical Center, Charleston, SC, USA. Electronic address: backs@musc.edu.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Gray', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, USA. Electronic address: graykm@musc.edu.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Santa Ana', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, USA; Ralph H. Johnson Veterans Affairs Medical Center, Charleston, SC, USA. Electronic address: santaana@musc.edu.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Jones', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, USA. Electronic address: jonjen@musc.edu.'}, {'ForeName': 'Amber M', 'Initials': 'AM', 'LastName': 'Jarnecke', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, USA. Electronic address: jarnecka@musc.edu.'}, {'ForeName': 'Jane E', 'Initials': 'JE', 'LastName': 'Joseph', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, USA. Electronic address: josep@musc.edu.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Prisciandaro', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, USA. Electronic address: priscian@musc.edu.'}, {'ForeName': 'Therese', 'Initials': 'T', 'LastName': 'Killeen', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, USA. Electronic address: killeent@musc.edu.'}, {'ForeName': 'Delisa G', 'Initials': 'DG', 'LastName': 'Brown', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, USA. Electronic address: browdg@musc.edu.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Taimina', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, USA. Electronic address: taimina@musc.edu.'}, {'ForeName': 'Ebele', 'Initials': 'E', 'LastName': 'Compean', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Malcolm', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, USA. Electronic address: malcolmr@musc.edu.'}, {'ForeName': 'Julianne C', 'Initials': 'JC', 'LastName': 'Flanagan', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, USA. Electronic address: hellmuth@musc.edu.'}, {'ForeName': 'Peter W', 'Initials': 'PW', 'LastName': 'Kalivas', 'Affiliation': 'Department of Neuroscience, College of Medicine, Medical University of South Carolina, Charleston, SC, USA. Electronic address: kalivasp@musc.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.105961'] 305,32252062,"Ketamine metabolites, clinical response, and gamma power in a randomized, placebo-controlled, crossover trial for treatment-resistant major depression.","A single, subanesthetic dose of (R,S)-ketamine (ketamine) exerts rapid and robust antidepressant effects. Several groups previously reported that (2S,6S;2R,6R)-hydroxynorketamine (HNK) had antidepressant effects in rodents, and that (2R,6R)-HNK increased cortical electroencephalographic gamma power. This exploratory study examined the relationship between ketamine metabolites, clinical response, psychotomimetic symptoms, and gamma power changes in 34 individuals (ages 18-65) with treatment-resistant depression (TRD) who received a single ketamine infusion (0.5 mg/kg) over 40 min. Plasma concentrations of ketamine, norketamine, and HNKs were measured at 40, 80, 120, and 230 min and at 1, 2, and 3 days post-infusion. Linear mixed models evaluated ketamine metabolites as mediators of antidepressant and psychotomimetic effects and their relationship to resting-state whole-brain magnetoencephalography (MEG) gamma power 6-9 h post-infusion. Three salient findings emerged. First, ketamine concentration positively predicted distal antidepressant response at Day 11 post-infusion, and an inverse relationship was observed between (2S,6S;2R,6R)-HNK concentration and antidepressant response at 3 and 7 days post-infusion. Norketamine concentration was not associated with antidepressant response. Second, ketamine, norketamine, and (2S,6S;2R,6R)-HNK concentrations at 40 min were positively associated with contemporaneous psychotomimetic symptoms; post-hoc analysis revealed that ketamine was the predominant contributor. Third, increased (2S,6S;2R,6R)-HNK maximum observed concentration (C max ) was associated with increased MEG gamma power. While contrary to preclinical observations and our a priori hypotheses, these exploratory results replicate those of a recently published study documenting a relationship between higher (2S,6S;2R,6R)-HNK concentrations and weaker antidepressant response in humans and provide further rationale for studying gamma power changes as potential biomarkers of antidepressant response.",2020,Norketamine concentration was not associated with antidepressant response.,['34 individuals (ages 18-65) with treatment-resistant depression (TRD) who received a'],"['placebo', 'ketamine', 'subanesthetic dose of (R,S)-ketamine (ketamine', '2S,6S;2R,6R)-hydroxynorketamine (HNK', 'Ketamine', 'single ketamine infusion']","['Plasma concentrations of ketamine, norketamine, and HNKs', '2S,6S;2R,6R)-HNK concentration and antidepressant response', 'ketamine, norketamine, and (2S,6S;2R,6R)-HNK concentrations', 'distal antidepressant response', 'Norketamine concentration', 'cortical electroencephalographic gamma power']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C2063866', 'cui_str': 'Therapy-Resistant Depression'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0068996', 'cui_str': 'norketamine'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C0017011', 'cui_str': 'Gamma radiation'}]",,0.0410552,Norketamine concentration was not associated with antidepressant response.,"[{'ForeName': 'Cristan A', 'Initials': 'CA', 'LastName': 'Farmer', 'Affiliation': 'Section on the Neurobiology and Treatment of Mood Disorders, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Jessica R', 'Initials': 'JR', 'LastName': 'Gilbert', 'Affiliation': 'Section on the Neurobiology and Treatment of Mood Disorders, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Ruin', 'Initials': 'R', 'LastName': 'Moaddel', 'Affiliation': 'National Institute on Aging, National Institutes of Health, Baltimore, MD, USA.'}, {'ForeName': 'Jomy', 'Initials': 'J', 'LastName': 'George', 'Affiliation': 'Clinical Pharmacokinetics Research Unit, Pharmacy Department, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Lilian', 'Initials': 'L', 'LastName': 'Adeojo', 'Affiliation': 'Clinical Pharmacokinetics Research Unit, Pharmacy Department, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Lovett', 'Affiliation': 'National Institute on Aging, National Institutes of Health, Baltimore, MD, USA.'}, {'ForeName': 'Allison C', 'Initials': 'AC', 'LastName': 'Nugent', 'Affiliation': 'Section on the Neurobiology and Treatment of Mood Disorders, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Bashkim', 'Initials': 'B', 'LastName': 'Kadriu', 'Affiliation': 'Section on the Neurobiology and Treatment of Mood Disorders, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Peixiong', 'Initials': 'P', 'LastName': 'Yuan', 'Affiliation': 'Section on the Neurobiology and Treatment of Mood Disorders, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Todd D', 'Initials': 'TD', 'LastName': 'Gould', 'Affiliation': 'Departments of Psychiatry, Pharmacology, and Anatomy and Neurobiology, University of Maryland School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Lawrence T', 'Initials': 'LT', 'LastName': 'Park', 'Affiliation': 'Section on the Neurobiology and Treatment of Mood Disorders, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Carlos A', 'Initials': 'CA', 'LastName': 'Zarate', 'Affiliation': 'Section on the Neurobiology and Treatment of Mood Disorders, National Institute of Mental Health, National Institutes of Health, Bethesda, MD, USA. zaratec@mail.nih.gov.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-020-0663-6'] 306,32265361,"Early Progression and Immune Reconstitution Inflammatory Syndrome During Treatment of Mild-To-Moderate Kaposi Sarcoma in Sub-Saharan Africa and South America: Incidence, Long-Term Outcomes, and Effects of Early Chemotherapy.","BACKGROUND Early progression of AIDS-associated Kaposi sarcoma (KS-PD) and immune reconstitution inflammatory syndrome (KS-IRIS) sometimes occur after the initiation of antiretroviral therapy (ART). METHODS Early KS-PD and KS-IRIS were assessed in the A5264/AMC-067 trial in which participants with mild-to-moderate AIDS-KS were randomized to initiate ART with either immediate or as-needed oral etoposide. Early KS-PD was defined as tumor progression within 12 weeks of ART initiation. When investigators had concern that early KS-PD was KS-IRIS, additional evaluations were performed. Suspected KS-IRIS was defined as early KS-PD accompanied by a CD4 count increase of ≥50 cells per cubic millimeter or plasma HIV-1 RNA decrease of ≥0.5 log10 copies/mL. Clinical outcome was a composite end point categorized as failure, stable, and response at 48 and 96 weeks compared with baseline. RESULTS Fifty of 190 participants had early KS-PD (27%): 28 had KS-IRIS and 22 were not evaluated for KS-IRIS. Early KS-PD and KS-IRIS incidences with immediate etoposide versus ART alone were 16% versus 39%, and 7% versus 21%, respectively. Week 48 clinical outcome was 45% failure, 18% stable, and 37% response for no early KS-PD; 82% failure, 2% stable, and 16% response for early KS-PD; and 88% failure, 0% stable, and 12% response for KS-IRIS. Cumulative incidence of KS tumor response by week 96 was 64% for no early KS-PD, 22% with early KS-PD, and 18% with KS-IRIS. CONCLUSIONS Early KS-PD, including suspected KS-IRIS, was common after starting ART for AIDS-KS and was associated with worse long-term clinical outcomes. Starting ART concurrently with etoposide reduced the incidence of both early KS-PD and KS-IRIS compared with ART alone.",2020,Week 48 clinical outcome was 45%,"['mild-to-moderate Kaposi sarcoma in sub-Saharan Africa and South America', 'Fifty of 190 participants had early KS-PD (27%): 28 had KS-IRIS, 22 were not evaluated for KS-IRIS', 'participants with mild-to-moderate AIDS-KS']","['immediate etoposide', 'early chemotherapy', 'etoposide']","['incidence of both early KS-PD and KS-IRIS', 'Early KS-PD and KS-IRIS incidences', 'Early KS-PD and KS-IRIS', 'Cumulative incidence of KS tumor response', 'plasma HIV-1']","[{'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0036220', 'cui_str': ""Kaposi's sarcoma""}, {'cui': 'C0001738', 'cui_str': 'Sub-Saharan Africa'}, {'cui': 'C0037713', 'cui_str': 'South America'}, {'cui': 'C4517622', 'cui_str': '190'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C3495846', 'cui_str': ""Immune reconstitution inflammatory syndrome associated Kaposi's sarcoma""}, {'cui': 'C0001175', 'cui_str': 'AIDS'}]","[{'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0015133', 'cui_str': 'Etoposide'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C3495846', 'cui_str': ""Immune reconstitution inflammatory syndrome associated Kaposi's sarcoma""}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0019704', 'cui_str': 'Human immunodeficiency virus type I'}]",,0.10907,Week 48 clinical outcome was 45%,"[{'ForeName': 'Mulinda', 'Initials': 'M', 'LastName': 'Nyirenda', 'Affiliation': 'Johns Hopkins Project, University of Malawi College of Medicine, Blantyre, Malawi.'}, {'ForeName': 'McNeil', 'Initials': 'M', 'LastName': 'Ngongondo', 'Affiliation': 'UNC Project Malawi, Lilongwe, Malawi.'}, {'ForeName': 'Minhee', 'Initials': 'M', 'LastName': 'Kang', 'Affiliation': 'Center for Biostatistics in AIDS Research, Harvard T.H. Chan School of Public Health, Boston, MA.'}, {'ForeName': 'Triin', 'Initials': 'T', 'LastName': 'Umbleja', 'Affiliation': 'Center for Biostatistics in AIDS Research, Harvard T.H. Chan School of Public Health, Boston, MA.'}, {'ForeName': 'Susan E', 'Initials': 'SE', 'LastName': 'Krown', 'Affiliation': 'AIDS Malignancy Consortium, New York, NY.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Godfrey', 'Affiliation': 'Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD.'}, {'ForeName': 'Wadzanai', 'Initials': 'W', 'LastName': 'Samaneka', 'Affiliation': 'Department of Medicine, University of Zimbabwe College of Health Sciences, Harare, Zimbabwe.'}, {'ForeName': 'Rosie', 'Initials': 'R', 'LastName': 'Mngqibisa', 'Affiliation': 'Durban International Clinical Research Site, Enhancing Care Foundation, Durban, South Africa.'}, {'ForeName': 'Brenda', 'Initials': 'B', 'LastName': 'Hoagland', 'Affiliation': 'Oswaldo Cruz Foundation, Evandro Chagas National Institute of Infectious Diseases, Rio de Janeiro, Brazil.'}, {'ForeName': 'Noluthando', 'Initials': 'N', 'LastName': 'Mwelase', 'Affiliation': 'University of Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Caruso', 'Affiliation': 'Frontier Science Foundation, Amherst, New York, NY.'}, {'ForeName': 'Oto', 'Initials': 'O', 'LastName': 'Martinez-Maza', 'Affiliation': 'Department of Obstetrics and Gynecology, David Geffen School of Medicine at UCLA, University of California, Los Angeles, CA.'}, {'ForeName': 'Dirk P', 'Initials': 'DP', 'LastName': 'Dittmer', 'Affiliation': 'Department of Microbiology & Immunology, University of North Carolina School of Medicine, and Lineberger Comprehensive Cancer Center, Chapel Hill, NC.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Borok', 'Affiliation': 'Department of Medicine, University of Zimbabwe College of Health Sciences, Harare, Zimbabwe.'}, {'ForeName': 'Mina C', 'Initials': 'MC', 'LastName': 'Hosseinipour', 'Affiliation': 'UNC Project Malawi, Lilongwe, Malawi.'}, {'ForeName': 'Thomas B', 'Initials': 'TB', 'LastName': 'Campbell', 'Affiliation': 'Department of Medicine/Division of Infectious Diseases, University of Colorado School of Medicine, Aurora, CO.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of acquired immune deficiency syndromes (1999),['10.1097/QAI.0000000000002361'] 307,32271843,Adaptive responses of histone modifications to resistance exercise in human skeletal muscle.,"Exercise training causes epigenetic changes in skeletal muscle, although it is unclear how resistance exercise (RE) affects histone modifications. The present study was carried out to investigate the effects of acute RE and RE training on gene expression profiles and histone modifications in human skeletal muscle. Healthy male adults were assigned to acute RE (n = 9, age = 20.5±4.3yr, BMI = 28.0±6.8kg/m2) or RE training (n = 21, age = 23.7±2.5yr, BMI = 24.2±2.7kg/m2) groups. Biopsy samples were obtained from the vastus lateralis muscle before and three hours after a single bout of acute RE, or 3-days after 10 weeks of RE training. RNA sequencing analysis revealed that 153 genes with GO terms including muscle development, stress response, metabolism, cell death, and transcription factor were significantly up-regulated (+291% vs. pre-acute RE) upon acute RE. Expressions of these genes were also greater (+9.6% vs. pre-RE training, p<0.05) in RE trained subjects. Significant up-regulation of acetylated histone 3 (H3) (+235%) and H3 mono-methylated at lysine 4 (+290%) and tri-methylated at lysine 27 (+849%), whereas down-regulation of H3.3 variant (-39%) distributions relative to total H3 were observed at transcriptionally activated loci after acute RE compared to pre-acute RE levels. Interestingly, the distribution of acetylated H3 was found to be up-regulated as compared to the level of total H3 after RE training (+40%, p<0.05). These results indicate that a single bout of RE drastically alters both gene expressions and histone modifications in human skeletal muscle. It is also suggested that enhanced histone acetylation is closely related to up-regulation of gene expressions after RE training.",2020,"Significant up-regulation of acetylated histone 3 (H3) (+235%) and H3 mono-methylated at lysine 4 (+290%) and tri-methylated at lysine 27 (+849%), whereas down-regulation of H3.3 variant (-39%) distributions relative to total H3 were observed at transcriptionally activated loci after acute RE compared to pre-acute RE levels.","['human skeletal muscle', 'Healthy male adults were assigned to acute RE (n = 9, age ']","['Exercise training', 'RE training', 'resistance exercise']","['muscle development, stress response, metabolism, cell death, and transcription factor']","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0686751', 'cui_str': 'Well male adult'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0949649', 'cui_str': 'Muscular Development'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0007587', 'cui_str': 'Cell death'}, {'cui': 'C0040649', 'cui_str': 'Genetic transcription'}]",,0.0231295,"Significant up-regulation of acetylated histone 3 (H3) (+235%) and H3 mono-methylated at lysine 4 (+290%) and tri-methylated at lysine 27 (+849%), whereas down-regulation of H3.3 variant (-39%) distributions relative to total H3 were observed at transcriptionally activated loci after acute RE compared to pre-acute RE levels.","[{'ForeName': 'Changhyun', 'Initials': 'C', 'LastName': 'Lim', 'Affiliation': 'Department of Kinesiology, McMaster University, Ontario, Canada.'}, {'ForeName': 'Junya', 'Initials': 'J', 'LastName': 'Shimizu', 'Affiliation': 'Department of Sports and Health Science, Matsumoto University, Nagano, Japan.'}, {'ForeName': 'Fuminori', 'Initials': 'F', 'LastName': 'Kawano', 'Affiliation': 'Department of Sports and Health Science, Matsumoto University, Nagano, Japan.'}, {'ForeName': 'Hyo Jeong', 'Initials': 'HJ', 'LastName': 'Kim', 'Affiliation': 'Department of Healthy Ageing, Korea National Sport University, Seoul, Korea.'}, {'ForeName': 'Chang Keun', 'Initials': 'CK', 'LastName': 'Kim', 'Affiliation': 'Exercise and Metabolism Research Center, Zhejiang Normal University, Jinhua, China.'}]",PloS one,['10.1371/journal.pone.0231321'] 308,32271833,A resilience group training program for people with multiple sclerosis: Results of a pilot single-blind randomized controlled trial and nested qualitative study.,"INTRODUCTION An Australian case series study demonstrated the effectiveness of the REsilience and Activities for every DaY for people with multiple sclerosis (READY for MS), a resilience group training program based on Acceptance and Commitment Therapy, in improving quality of life in people with MS. This study aimed to evaluate the feasibility and acceptability of the Italian READY for MS program, and to preliminary assess its efficacy when compared to an active control intervention (group relaxation). METHODS Single-blind phase II randomized controlled trial (RCT) and nested qualitative study (ISRCTN registration number: 38971970). Health-related quality of life (primary study outcome), mood, resilience, psychological flexibility and its protective factors were measured at baseline, after seven, 12 and 24 weeks. READY participants completed the purpose-built satisfaction questionnaire after 12 weeks. After trial completion, the control group also received READY. One-to-one participant interviews were conducted within three months of finishing the READY groups. RESULTS Four intervention groups were conducted with 39 participants (20 READY, 19 relaxation). Two patients (READY) withdrew before beginning the intervention due to unexpected work commitments. Feasibility and acceptability of READY were good, with high participant engagement and satisfaction. No statistical effects of READY were detected vs relaxation. Thirty participants were interviewed (18 READY; 12 relaxation + READY). Content data analysis revealed seven overarching themes: ""Attitudes towards participation""; ""Perceptions of program composition""; ""Program impacts on life domains""; ""Program active elements""; ""Program improvement trajectories""; ""Program differences and similarities""; ""Suggested READY improvements"". CONCLUSION READY was well accepted by MS patients with varied socio-demographic and clinical characteristics. Qualitative (but not quantitative) data provided evidence in favour of READY. Our findings will inform methodological and intervention refinements for the multi-centre RCT that will follow.",2020,No statistical effects of READY were detected vs relaxation.,"['people with multiple sclerosis', 'people with MS', 'Thirty participants', 'people with multiple sclerosis (READY for MS']",['active control intervention'],"['Health-related quality of life (primary study outcome), mood, resilience, psychological flexibility and its protective factors', 'feasibility and acceptability']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C3816446', 'cui_str': '30'}]","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0543472', 'cui_str': 'Outcome Studies'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0683253', 'cui_str': 'Psychological resilience'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0679688', 'cui_str': 'Protective Factors'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}]",30.0,0.0652054,No statistical effects of READY were detected vs relaxation.,"[{'ForeName': 'Ambra Mara', 'Initials': 'AM', 'LastName': 'Giovannetti', 'Affiliation': 'Unit of Neuroepidemiology, Fondazione IRCCS Istituto Neurologico Carlo Besta, Milan, Italy.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Quintas', 'Affiliation': 'Unit of Neuroimmunology and Neuromuscular Diseases, Fondazione IRCCS Istituto Neurologico Carlo Besta, Milan, Italy.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Tramacere', 'Affiliation': 'Department of Research and Clinical Development, Scientific Directorate, Fondazione IRCCS Istituto Neurologico Carlo Besta, Milan, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Giordano', 'Affiliation': 'Unit of Neuroepidemiology, Fondazione IRCCS Istituto Neurologico Carlo Besta, Milan, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Confalonieri', 'Affiliation': 'Unit of Neuroimmunology and Neuromuscular Diseases, Fondazione IRCCS Istituto Neurologico Carlo Besta, Milan, Italy.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Messmer Uccelli', 'Affiliation': 'Italian Multiple Sclerosis Society and Research Foundation (FISM), Genoa, Italy.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Solari', 'Affiliation': 'Unit of Neuroepidemiology, Fondazione IRCCS Istituto Neurologico Carlo Besta, Milan, Italy.'}, {'ForeName': 'Kenneth Ian', 'Initials': 'KI', 'LastName': 'Pakenham', 'Affiliation': 'School of Psychology, Faculty of Health and Behavioural Sciences, University of Queensland, Brisbane, QLD, Australia.'}]",PloS one,['10.1371/journal.pone.0231380'] 309,32275730,Effects of peer tutoring on middle school students' mathematics self-concepts.,"The effects of peer tutoring on students' mathematics self-concepts were examined. The Marsh questionnaire was used to measure students' mathematics self-concepts before and after implementation of a peer tutoring program. A pretest posttest control group design was employed. Study participants included 376 students from grades 7 to 9 (12 to 15 years old). No statistically significant differences were reported between the pretest and the posttest for any of the control groups. Statistically significant improvements were reported for all grades for the experimental groups. An average increment of 13.4% was reported for students in the experimental group, and the overall effect size was reported to be medium (Hedges' g = 0.48). No statistically significant differences were reported across grades for the experimental group. The main conclusion of this study is that same-age and reciprocal peer tutoring may be very beneficial for middle school students' mathematics self-concepts. Several recommendations for field practitioners emanated from the study: use same-age and reciprocal tutoring over cross-age and fixed peer tutoring; schedule tutoring programs for four weeks or less with two to four sessions of 25 minutes or less per week for each tutoring session; and, include a control group in research studies.",2020,The Marsh questionnaire was used to measure students' mathematics self-concepts before and after implementation of a peer tutoring program.,"[""middle school students' mathematics self-concepts"", 'Study participants included 376 students from grades 7 to 9 (12 to 15 years old']",['peer tutoring'],['overall effect size'],"[{'cui': 'C0557797', 'cui_str': 'Middle school'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0024934', 'cui_str': 'Mathematics'}, {'cui': 'C0036594', 'cui_str': 'Self Concept'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]",[],"[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0456389', 'cui_str': 'Size'}]",376.0,0.0160382,The Marsh questionnaire was used to measure students' mathematics self-concepts before and after implementation of a peer tutoring program.,"[{'ForeName': 'Lidon', 'Initials': 'L', 'LastName': 'Moliner', 'Affiliation': 'Department of Education, Jaume I University, Castellon, Spain.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Alegre', 'Affiliation': 'Department of Education, Valladolid University, Valladolid, Spain.'}]",PloS one,['10.1371/journal.pone.0231410'] 310,32289474,"5-Year Update of a Multi-Institution, Prospective Phase 2 Hypofractionated Postmastectomy Radiation Therapy Trial.","PURPOSE Hypofractionation in the setting of postmastectomy radiation (PMRT) is not currently the standard of care in most countries. Here we present a 5-year update of our multi-institutional, phase 2 prospective trial evaluating a novel 15-day hypofractionated PMRT regimen. METHODS AND MATERIALS Patients were enrolled to receive 3.33 Gy daily to the chest wall (or reconstructed breast) and regional lymphatics in 11 fractions with an optional 4-fraction mastectomy scar boost. The primary endpoint was freedom from grade 3 or higher late non-reconstruction-related radiation toxicities. Toxicities were scored using Common Terminology Criteria for Adverse Events v4.0. Secondary endpoints included local and locoregional recurrence rates, cosmesis, and reconstruction complications. RESULTS After enrolling 69 patients with stage II-IIIa breast cancer, 67 women were eligible for analysis. At a median follow up of 54 months, there were no acute or late grade 3 and 4 nonreconstruction reported toxicities. The grade 2 or greater late toxicity rate was only 12% and comprised grade 2 pain, fatigue, and lymphedema that persisted beyond 6 months after completion of radiation therapy. Only 3 women (4.6%) experienced a chest wall or nodal recurrence as a first site of relapse. Freedom from local failure, including local failure after distant relapse, was 92% at 5 years, and the 5-year overall survival was 90%. CONCLUSIONS This is the first prospective trial conducted in the United States to demonstrate the safe and effective use of hypofractionated PMRT. We have demonstrated a low complication rate while achieving excellent local control. Toxicity was better than anticipated based on previously published series of PMRT toxicities. Although our fractionation was novel, the radiobiological equivalent dose is similar to other hypofractionation schedules. This trial was the basis for the creation of Alliance A221505 (RT CHARM), which is currently accruing patients in a phase 3 randomized design.",2020,"Freedom from local failure, including local failure after distant relapse was 92% at 5 years and the 5-year overall survival was 90%. ","['Patients were enrolled to receive 3.33 Gray (Gy) daily to the', '69 patients with stage II-IIIa breast cancer, 67 women were eligible for analysis']","['post mastectomy radiation (PMRT', 'chest wall (or reconstructed breast) and regional lymphatics in 11 fractions with an optional 4 fraction mastectomy scar boost', 'Alliance Axxxxx (xxxxx', 'hypofractionated PMRT']","['late toxicity rate', 'low complication rate', 'toxicities', 'local failure after distant relapse', 'chest wall or nodal recurrence', 'Toxicities', 'Toxicity', 'freedom from grade 3 or higher late non-reconstruction related radiation toxicities', 'pain, fatigue and lymphedema', 'local and locoregional recurrence rates, cosmesis and reconstruction complications', '5-year overall survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517690', 'cui_str': '3.33'}, {'cui': 'C0556636', 'cui_str': 'Gy'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0024881', 'cui_str': 'Mastectomy'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0205076', 'cui_str': 'Chest wall structure'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0024235', 'cui_str': 'Structure of lymphatic system'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C0008767', 'cui_str': 'Scarring'}]","[{'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0443203', 'cui_str': 'Distant'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0205076', 'cui_str': 'Chest wall structure'}, {'cui': 'C0443268', 'cui_str': 'Nodal'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C1510432', 'cui_str': 'Radiation sickness'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0024236', 'cui_str': 'Lymphedema'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",69.0,0.105768,"Freedom from local failure, including local failure after distant relapse was 92% at 5 years and the 5-year overall survival was 90%. ","[{'ForeName': 'Matthew M', 'Initials': 'MM', 'LastName': 'Poppe', 'Affiliation': 'Huntsman Cancer Hospital, University of Utah, Salt Lake City, Utah. Electronic address: matthew.poppe@hci.utah.edu.'}, {'ForeName': 'Zeinab A', 'Initials': 'ZA', 'LastName': 'Yehia', 'Affiliation': 'Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Baker', 'Affiliation': 'Huntsman Cancer Hospital, University of Utah, Salt Lake City, Utah.'}, {'ForeName': 'Sharad', 'Initials': 'S', 'LastName': 'Goyal', 'Affiliation': 'George Washington University, Washington, DC.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Toppmeyer', 'Affiliation': 'Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey.'}, {'ForeName': 'Laurie', 'Initials': 'L', 'LastName': 'Kirstein', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York City, New York.'}, {'ForeName': 'Chunxia', 'Initials': 'C', 'LastName': 'Chen', 'Affiliation': 'Rutgers School of Public Health, Piscataway, New Jersey.'}, {'ForeName': 'D F', 'Initials': 'DF', 'LastName': 'Moore', 'Affiliation': 'Rutgers School of Public Health, Piscataway, New Jersey.'}, {'ForeName': 'Bruce G', 'Initials': 'BG', 'LastName': 'Haffty', 'Affiliation': 'Rutgers Cancer Institute of New Jersey, New Brunswick, New Jersey.'}, {'ForeName': 'Atif J', 'Initials': 'AJ', 'LastName': 'Khan', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York City, New York.'}]","International journal of radiation oncology, biology, physics",['10.1016/j.ijrobp.2020.03.020'] 311,32018189,No changes in gut microbiota after two-week sleep extension in chronically sleep-deprived individuals.,"BACKGROUND Gut microbiota has been linked to obesity and glucose metabolism. Insufficient sleep is also known to be associated with insulin resistance, and sleep extension was reported to improve glucose metabolism in short sleepers. This study aimed to explore whether sleep extension was associated with changes in gut microbiota and whether there was a relationship with glucose parameters. METHODS We performed a secondary analysis of eight short-seeping but otherwise healthy subjects who participated in a cross over study of two-week home sleep extension and two weeks of habitual sleep. After each sleep condition, stool samples were collected and glucose parameters were obtained. Stool DNA extraction was performed and 16S rRNA was sequenced by MiSeq™. The resulting sequence data were processed to infer relative abundances of taxa present and then analyzed to detect any differences in the abundances of the taxa or overall diversity of the microbiome. RESULTS Mean (SD) sleep duration during habitual sleep and sleep extension was 5.58 (0.53) and 6.60 (0.43) hours/night, respectively. Using the Bray-Curtis index, there was no significant dissimilarity of the genus-level microbial community between the two sleeping conditions (ADONIS, R 2  = 0.017, p = 0.988 and ANOSIM, R = -0.131, p = 0.991). Within-sample microbial diversity (ie, the Shannon index) also did not find significant differences (p = 0.861). There was no significant relationship between per-individual dissimilarity and objective and subjective sleep variables, or glycemic parameters. Only higher sleep efficiency was related to higher abundance of the phyla Tenericutes. CONCLUSION Two-week sleep extension in short sleepers was not associated with changes in gut microbiota.",2020,"Within-sample microbial diversity (ie, the Shannon index) also did not find significant differences (p = 0.861).","['chronically sleep-deprived individuals', 'eight short-seeping but otherwise healthy subjects who participated in a cross over study of two-week home sleep extension and two weeks of habitual sleep']",[],"['sleep efficiency', 'per-individual dissimilarity and objective and subjective sleep variables, or glycemic parameters', 'gut microbiota', 'Mean (SD) sleep duration during habitual sleep and sleep extension']","[{'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0150097', 'cui_str': 'Crossover Trials'}, {'cui': 'C4082118', 'cui_str': 'Two weeks'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C0205353', 'cui_str': 'Habitual (qualifier value)'}]",[],"[{'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C4018878', 'cui_str': 'Gastrointestinal Microbial Community'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0205353', 'cui_str': 'Habitual (qualifier value)'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}]",,0.0206521,"Within-sample microbial diversity (ie, the Shannon index) also did not find significant differences (p = 0.861).","[{'ForeName': 'Sirimon', 'Initials': 'S', 'LastName': 'Reutrakul', 'Affiliation': 'Division of Endocrinology and Metabolism, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, Thailand; Division of Endocrinology, Diabetes and Metabolism, Department of Medicine, University of Illinois at Chicago, Chicago, IL, USA. Electronic address: sreutrak10800@gmail.com.'}, {'ForeName': 'Apichart', 'Initials': 'A', 'LastName': 'So-Ngern', 'Affiliation': 'Division of Sleep Medicine, Department of Medicine, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand.'}, {'ForeName': 'Naricha', 'Initials': 'N', 'LastName': 'Chirakalwasan', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Department of Medicine, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand; Excellence Center for Sleep Disorders, King Chulalongkorn Memorial Hospital, Thai Red Cross Society, Bangkok, Thailand.'}, {'ForeName': 'Sunee', 'Initials': 'S', 'LastName': 'Saetung', 'Affiliation': 'Division of Endocrinology and Metabolism, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Suwannee', 'Initials': 'S', 'LastName': 'Chanprasertyothin', 'Affiliation': 'Research Center, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Ammarin', 'Initials': 'A', 'LastName': 'Thakkinstian', 'Affiliation': 'Section for Clinical Epidemiology and Biostatistics, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'George E', 'Initials': 'GE', 'LastName': 'Chlipala', 'Affiliation': 'Research Informatics Core, Research Resources Center, University of Illinois at Chicago, Chicago, IL, USA.'}]",Sleep medicine,['10.1016/j.sleep.2019.08.022'] 312,32052468,Linguistic predictability influences auditory stimulus classification within two concurrent speech streams.,"Acoustic predictability has been shown to affect auditory stream segregation, while linguistic predictability is known to be an important factor in speech comprehension. We tested the effects of linguistic predictability on auditory stream segregation and target detection by assessing the event-related potentials elicited by targets and distractors in participants presented with two concurrent speech streams. The linguistic cues of predictability varied over four levels. In the three real speech conditions, natural speech was presented with intact phonotactics and sentence prosody: normal speech, word-salad (randomized word order within each sentence), and pseudo-words (randomized syllable order within each sentence). The fourth (control) condition delivered a spectrally rotated version of the normal speech condition. Participants were instructed to attend one stream and respond to the natural cough sounds embedded in it. Coughs were present in both streams, serving as targets in the attended and as distractors in the unattended stream. We expected improved target detection with increasing linguistic predictability. The target-related N2b component's amplitude monotonically increased from the pseudo-word to the word-salad and normal speech condition, while no predictability effects were observed for the P3b amplitude or for behavioral responses. The dissociation between the N2b and P3b/behavioral effect suggests that while linguistic predictability enhanced the process of classifying stimuli as potential targets, this did not affect their detection. Furthermore, the observed nonmonotonic distractor N2 (probably MMN) amplitude increase with increasing linguistic predictability is compatible with the notion that linguistic predictability can modulate auditory stream segregation and/or stream selection.",2020,"The target-related N2b component's amplitude monotonically increased from the pseudo-word to the word-salad and normal speech condition, while no predictability effects were observed for the P3b amplitude or for behavioral responses.",['participants presented with two concurrent speech streams'],"['natural speech was presented with intact phonotactics and sentence prosody: normal speech, word-salad (randomized word order within each sentence), and pseudo-words (randomized syllable order within each sentence']",['linguistic predictability'],"[{'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0205420', 'cui_str': 'Concurrent (qualifier value)'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0442540', 'cui_str': 'Streams'}]","[{'cui': 'C0205296', 'cui_str': 'Natural (qualifier value)'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0205266', 'cui_str': 'Intact (qualifier value)'}, {'cui': 'C0233743', 'cui_str': 'Prosody, function (observable entity)'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0233648', 'cui_str': 'Word salad (finding)'}, {'cui': 'C4284072', 'cui_str': 'Order (record artifact)'}, {'cui': 'C0205237', 'cui_str': 'False (qualifier value)'}]","[{'cui': 'C0023741', 'cui_str': 'Linguistics'}]",,0.0294384,"The target-related N2b component's amplitude monotonically increased from the pseudo-word to the word-salad and normal speech condition, while no predictability effects were observed for the P3b amplitude or for behavioral responses.","[{'ForeName': 'Orsolya', 'Initials': 'O', 'LastName': 'Szalárdy', 'Affiliation': 'Faculty of Medicine, Institute of Behavioural Sciences, Semmelweis University, Budapest, Hungary.'}, {'ForeName': 'Brigitta', 'Initials': 'B', 'LastName': 'Tóth', 'Affiliation': 'Institute of Cognitive Neuroscience and Psychology, Research Centre for Natural Sciences, Hungarian Academy of Sciences, Budapest, Hungary.'}, {'ForeName': 'Dávid', 'Initials': 'D', 'LastName': 'Farkas', 'Affiliation': 'Analytics Development, Performance Management and Analytics, Business Development, Integrated Supply Chain Management, Nokia Business Services, Nokia Operations, Nokia, Budapest, Hungary.'}, {'ForeName': 'Gábor', 'Initials': 'G', 'LastName': 'Orosz', 'Affiliation': 'Department of Psychology, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Ferenc', 'Initials': 'F', 'LastName': 'Honbolygó', 'Affiliation': 'Brain Imaging Centre, Research Centre for Natural Sciences, Hungarian Academy of Sciences, Budapest, Hungary.'}, {'ForeName': 'István', 'Initials': 'I', 'LastName': 'Winkler', 'Affiliation': 'Institute of Cognitive Neuroscience and Psychology, Research Centre for Natural Sciences, Hungarian Academy of Sciences, Budapest, Hungary.'}]",Psychophysiology,['10.1111/psyp.13547'] 313,32053298,Plasma Exchange and Glucocorticoids in Severe ANCA-Associated Vasculitis.,"BACKGROUND More effective and safer treatments are needed for antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis. METHODS We conducted a randomized trial with a 2-by-2 factorial design to evaluate the use of plasma exchange and two regimens of oral glucocorticoids in patients with severe ANCA-associated vasculitis (defined by an estimated glomerular filtration rate of <50 ml per minute per 1.73 m 2 of body-surface area or diffuse pulmonary hemorrhage). Patients were randomly assigned to undergo plasma exchange (seven plasma exchanges within 14 days after randomization) or no plasma exchange (control group). Patients were also randomly assigned to follow either a standard-dose regimen or a reduced-dose regimen of oral glucocorticoids. Patients were followed for up to 7 years for the primary composite outcome of death from any cause or end-stage kidney disease (ESKD). RESULTS Death from any cause or ESKD occurred in 100 of 352 patients (28.4%) in the plasma-exchange group and in 109 of 352 patients (31.0%) in the control group (hazard ratio, 0.86; 95% confidence interval [CI], 0.65 to 1.13; P = 0.27). The results were similar in subgroup analyses and in analyses of secondary outcomes. We also assessed the noninferiority of a reduced-dose regimen of glucocorticoids to a standard-dose regimen, using a noninferiority margin of 11 percentage points. Death from any cause or ESKD occurred in 92 of 330 patients (27.9%) in the reduced-dose group and in 83 of 325 patients (25.5%) in the standard-dose group (absolute risk difference, 2.3 percentage points; 90% CI, -3.4 to 8.0), which met the criterion for noninferiority. Serious infections at 1 year were less common in the reduced-dose group than in the standard-dose group (incidence rate ratio, 0.69; 95% CI, 0.52 to 0.93), but other secondary outcomes were similar in the two groups. CONCLUSIONS Among patients with severe ANCA-associated vasculitis, the use of plasma exchange did not reduce the incidence of death or ESKD. A reduced-dose regimen of glucocorticoids was noninferior to a standard-dose regimen with respect to death or ESKD. (Funded by the U.K. National Institute for Health Research and others; PEXIVAS Current Controlled Trials number, ISRCTN07757494; ClinicalTrials.gov number, NCT00987389.).",2020,A reduced-dose regimen of glucocorticoids was noninferior to a standard-dose regimen with respect to death or ESKD.,"['patients with severe ANCA-associated vasculitis (defined by an estimated glomerular filtration rate of <50 ml per minute per 1.73 m 2 of body-surface area or diffuse pulmonary hemorrhage', 'patients with severe ANCA-associated vasculitis']","['plasma exchange (seven plasma exchanges within 14 days after randomization) or no plasma exchange (control group', 'standard-dose regimen or a reduced-dose regimen of oral glucocorticoids', 'glucocorticoids', 'oral glucocorticoids']","['Serious infections', 'Death', 'Death from any cause or ESKD', 'incidence of death or ESKD', 'death from any cause or end-stage kidney disease (ESKD']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C2717865', 'cui_str': 'Pauci-Immune Vasculitis'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C3811844'}, {'cui': 'C0702093', 'cui_str': '/min'}, {'cui': 'C0005902', 'cui_str': 'Body Surface Area'}, {'cui': 'C0205219', 'cui_str': 'Diffuse (qualifier value)'}, {'cui': 'C0151701', 'cui_str': 'Pulmonary hemorrhage (disorder)'}]","[{'cui': 'C0032113', 'cui_str': 'Plasma Exchange'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C3540778', 'cui_str': 'Glucocorticoids'}]","[{'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0022661', 'cui_str': 'End-Stage Kidney Disease'}]",,0.369926,A reduced-dose regimen of glucocorticoids was noninferior to a standard-dose regimen with respect to death or ESKD.,"[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Walsh', 'Affiliation': ""From the Population Health Research Institute, McMaster University-Hamilton Health Sciences (M.W.), and the Departments of Medicine (M.W., N.K.) and Health Research Methods, Evidence, and Impact (M.W.), McMaster University, and St. Joseph's Healthcare (M.W., N.K., A.M.), Hamilton, ON, the Division of Nephrology and the Li Ka Shing Knowledge Institute, St. Michael's Hospital (R.W.), and the Department of Medicine (R.W.), the Vasculitis Clinic, Department of Rheumatology (C.P., S.C.), and Mount Sinai Hospital, Division of Rheumatology (C.P., S.C.), University of Toronto, Toronto, the Department of Medicine, University of Calgary, Calgary, AB (L.P.G.), the Department of Medicine, University of British Columbia, Vancouver (A.L.), and the Department of Medicine, University of Western Ontario, London (W.F.C.) - all in Canada; the Division of Rheumatology, Departments of Medicine and Biostatistics, Epidemiology, and Informatics, University of Pennsylvania, Philadelphia (P.A.M., C.A.M.); Royal Adelaide Hospital and the University of Adelaide, Adelaide (C.-A.P.), and the Australasian Kidney Trials Network, University of Queensland, Brisbane (C.M.H., D.R.) - all in Australia; Rigshospitalet University Hospital, Department of Nephrology, Copenhagen (W.M.S.); Assistance Publique-Hôpitaux de Paris, Hôpital Cochin, Université Paris Descartes, Paris (X.P., L.G.); the Faculty of Medicine, University of Miyazaki, Miyazaki (S.F.), and the Institute for Advancement of Clinical and Translational Science, Kyoto University Hospital, and the Clinical and Translational Research Center, University Hospital, Kyoto Prefectural University of Medicine, Kyoto (T.I.-I.) - all in Japan; Royal Berkshire Hospital, Reading (O.F.), the Institute of Clinical Sciences (L.H.) and the Birmingham Clinical Trials Unit, Institute of Applied Health Research (S.M., N.I.), University of Birmingham, Birmingham, the Royal Devon and Exeter NHS Foundation Trust, Exeter (L.S.), the Department of Medicine, Imperial College London (C.D.P.), and Guys and St. Thomas' NHS Foundation Trust (A.L.C.), London, and the Department of Medicine, University of Cambridge (B.B., E.B., D.R.W.J.), and Addenbrooke's Hospital (D.R.W.J.), Cambridge - all in the United Kingdom; Spedali Civili di Brescia, Università di Brescia, Brescia, Italy (G.G.); the Division of Pulmonary and Critical Care Medicine, Mayo Clinic, Rochester, MN (U.S.); the Department of Nephrology, General University Hospital, Charles University, Prague, Czech Republic (V.T.); the Renal Service, Waitemata District Health Board, and the Department of Medicine, University of Auckland, Auckland, New Zealand (J.R.Z.); Jagiellonian University Medical College, Krakow, Poland (W.S.); and the Primary Systemic Vasculitides Clinic, Instituto Nacional de Enfermedades Respiratorias, Mexico City (L.F.F.-S.).""}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Merkel', 'Affiliation': ""From the Population Health Research Institute, McMaster University-Hamilton Health Sciences (M.W.), and the Departments of Medicine (M.W., N.K.) and Health Research Methods, Evidence, and Impact (M.W.), McMaster University, and St. Joseph's Healthcare (M.W., N.K., A.M.), Hamilton, ON, the Division of Nephrology and the Li Ka Shing Knowledge Institute, St. Michael's Hospital (R.W.), and the Department of Medicine (R.W.), the Vasculitis Clinic, Department of Rheumatology (C.P., S.C.), and Mount Sinai Hospital, Division of Rheumatology (C.P., S.C.), University of Toronto, Toronto, the Department of Medicine, University of Calgary, Calgary, AB (L.P.G.), the Department of Medicine, University of British Columbia, Vancouver (A.L.), and the Department of Medicine, University of Western Ontario, London (W.F.C.) - all in Canada; the Division of Rheumatology, Departments of Medicine and Biostatistics, Epidemiology, and Informatics, University of Pennsylvania, Philadelphia (P.A.M., C.A.M.); Royal Adelaide Hospital and the University of Adelaide, Adelaide (C.-A.P.), and the Australasian Kidney Trials Network, University of Queensland, Brisbane (C.M.H., D.R.) - all in Australia; Rigshospitalet University Hospital, Department of Nephrology, Copenhagen (W.M.S.); Assistance Publique-Hôpitaux de Paris, Hôpital Cochin, Université Paris Descartes, Paris (X.P., L.G.); the Faculty of Medicine, University of Miyazaki, Miyazaki (S.F.), and the Institute for Advancement of Clinical and Translational Science, Kyoto University Hospital, and the Clinical and Translational Research Center, University Hospital, Kyoto Prefectural University of Medicine, Kyoto (T.I.-I.) - all in Japan; Royal Berkshire Hospital, Reading (O.F.), the Institute of Clinical Sciences (L.H.) and the Birmingham Clinical Trials Unit, Institute of Applied Health Research (S.M., N.I.), University of Birmingham, Birmingham, the Royal Devon and Exeter NHS Foundation Trust, Exeter (L.S.), the Department of Medicine, Imperial College London (C.D.P.), and Guys and St. Thomas' NHS Foundation Trust (A.L.C.), London, and the Department of Medicine, University of Cambridge (B.B., E.B., D.R.W.J.), and Addenbrooke's Hospital (D.R.W.J.), Cambridge - all in the United Kingdom; Spedali Civili di Brescia, Università di Brescia, Brescia, Italy (G.G.); the Division of Pulmonary and Critical Care Medicine, Mayo Clinic, Rochester, MN (U.S.); the Department of Nephrology, General University Hospital, Charles University, Prague, Czech Republic (V.T.); the Renal Service, Waitemata District Health Board, and the Department of Medicine, University of Auckland, Auckland, New Zealand (J.R.Z.); Jagiellonian University Medical College, Krakow, Poland (W.S.); and the Primary Systemic Vasculitides Clinic, Instituto Nacional de Enfermedades Respiratorias, Mexico City (L.F.F.-S.).""}, {'ForeName': 'Chen-Au', 'Initials': 'CA', 'LastName': 'Peh', 'Affiliation': ""From the Population Health Research Institute, McMaster University-Hamilton Health Sciences (M.W.), and the Departments of Medicine (M.W., N.K.) and Health Research Methods, Evidence, and Impact (M.W.), McMaster University, and St. Joseph's Healthcare (M.W., N.K., A.M.), Hamilton, ON, the Division of Nephrology and the Li Ka Shing Knowledge Institute, St. Michael's Hospital (R.W.), and the Department of Medicine (R.W.), the Vasculitis Clinic, Department of Rheumatology (C.P., S.C.), and Mount Sinai Hospital, Division of Rheumatology (C.P., S.C.), University of Toronto, Toronto, the Department of Medicine, University of Calgary, Calgary, AB (L.P.G.), the Department of Medicine, University of British Columbia, Vancouver (A.L.), and the Department of Medicine, University of Western Ontario, London (W.F.C.) - all in Canada; the Division of Rheumatology, Departments of Medicine and Biostatistics, Epidemiology, and Informatics, University of Pennsylvania, Philadelphia (P.A.M., C.A.M.); Royal Adelaide Hospital and the University of Adelaide, Adelaide (C.-A.P.), and the Australasian Kidney Trials Network, University of Queensland, Brisbane (C.M.H., D.R.) - all in Australia; Rigshospitalet University Hospital, Department of Nephrology, Copenhagen (W.M.S.); Assistance Publique-Hôpitaux de Paris, Hôpital Cochin, Université Paris Descartes, Paris (X.P., L.G.); the Faculty of Medicine, University of Miyazaki, Miyazaki (S.F.), and the Institute for Advancement of Clinical and Translational Science, Kyoto University Hospital, and the Clinical and Translational Research Center, University Hospital, Kyoto Prefectural University of Medicine, Kyoto (T.I.-I.) - all in Japan; Royal Berkshire Hospital, Reading (O.F.), the Institute of Clinical Sciences (L.H.) and the Birmingham Clinical Trials Unit, Institute of Applied Health Research (S.M., N.I.), University of Birmingham, Birmingham, the Royal Devon and Exeter NHS Foundation Trust, Exeter (L.S.), the Department of Medicine, Imperial College London (C.D.P.), and Guys and St. Thomas' NHS Foundation Trust (A.L.C.), London, and the Department of Medicine, University of Cambridge (B.B., E.B., D.R.W.J.), and Addenbrooke's Hospital (D.R.W.J.), Cambridge - all in the United Kingdom; Spedali Civili di Brescia, Università di Brescia, Brescia, Italy (G.G.); the Division of Pulmonary and Critical Care Medicine, Mayo Clinic, Rochester, MN (U.S.); the Department of Nephrology, General University Hospital, Charles University, Prague, Czech Republic (V.T.); the Renal Service, Waitemata District Health Board, and the Department of Medicine, University of Auckland, Auckland, New Zealand (J.R.Z.); Jagiellonian University Medical College, Krakow, Poland (W.S.); and the Primary Systemic Vasculitides Clinic, Instituto Nacional de Enfermedades Respiratorias, Mexico City (L.F.F.-S.).""}, {'ForeName': 'Wladimir M', 'Initials': 'WM', 'LastName': 'Szpirt', 'Affiliation': ""From the Population Health Research Institute, McMaster University-Hamilton Health Sciences (M.W.), and the Departments of Medicine (M.W., N.K.) and Health Research Methods, Evidence, and Impact (M.W.), McMaster University, and St. Joseph's Healthcare (M.W., N.K., A.M.), Hamilton, ON, the Division of Nephrology and the Li Ka Shing Knowledge Institute, St. Michael's Hospital (R.W.), and the Department of Medicine (R.W.), the Vasculitis Clinic, Department of Rheumatology (C.P., S.C.), and Mount Sinai Hospital, Division of Rheumatology (C.P., S.C.), University of Toronto, Toronto, the Department of Medicine, University of Calgary, Calgary, AB (L.P.G.), the Department of Medicine, University of British Columbia, Vancouver (A.L.), and the Department of Medicine, University of Western Ontario, London (W.F.C.) - all in Canada; the Division of Rheumatology, Departments of Medicine and Biostatistics, Epidemiology, and Informatics, University of Pennsylvania, Philadelphia (P.A.M., C.A.M.); Royal Adelaide Hospital and the University of Adelaide, Adelaide (C.-A.P.), and the Australasian Kidney Trials Network, University of Queensland, Brisbane (C.M.H., D.R.) - all in Australia; Rigshospitalet University Hospital, Department of Nephrology, Copenhagen (W.M.S.); Assistance Publique-Hôpitaux de Paris, Hôpital Cochin, Université Paris Descartes, Paris (X.P., L.G.); the Faculty of Medicine, University of Miyazaki, Miyazaki (S.F.), and the Institute for Advancement of Clinical and Translational Science, Kyoto University Hospital, and the Clinical and Translational Research Center, University Hospital, Kyoto Prefectural University of Medicine, Kyoto (T.I.-I.) - all in Japan; Royal Berkshire Hospital, Reading (O.F.), the Institute of Clinical Sciences (L.H.) and the Birmingham Clinical Trials Unit, Institute of Applied Health Research (S.M., N.I.), University of Birmingham, Birmingham, the Royal Devon and Exeter NHS Foundation Trust, Exeter (L.S.), the Department of Medicine, Imperial College London (C.D.P.), and Guys and St. Thomas' NHS Foundation Trust (A.L.C.), London, and the Department of Medicine, University of Cambridge (B.B., E.B., D.R.W.J.), and Addenbrooke's Hospital (D.R.W.J.), Cambridge - all in the United Kingdom; Spedali Civili di Brescia, Università di Brescia, Brescia, Italy (G.G.); the Division of Pulmonary and Critical Care Medicine, Mayo Clinic, Rochester, MN (U.S.); the Department of Nephrology, General University Hospital, Charles University, Prague, Czech Republic (V.T.); the Renal Service, Waitemata District Health Board, and the Department of Medicine, University of Auckland, Auckland, New Zealand (J.R.Z.); Jagiellonian University Medical College, Krakow, Poland (W.S.); and the Primary Systemic Vasculitides Clinic, Instituto Nacional de Enfermedades Respiratorias, Mexico City (L.F.F.-S.).""}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Puéchal', 'Affiliation': ""From the Population Health Research Institute, McMaster University-Hamilton Health Sciences (M.W.), and the Departments of Medicine (M.W., N.K.) and Health Research Methods, Evidence, and Impact (M.W.), McMaster University, and St. Joseph's Healthcare (M.W., N.K., A.M.), Hamilton, ON, the Division of Nephrology and the Li Ka Shing Knowledge Institute, St. Michael's Hospital (R.W.), and the Department of Medicine (R.W.), the Vasculitis Clinic, Department of Rheumatology (C.P., S.C.), and Mount Sinai Hospital, Division of Rheumatology (C.P., S.C.), University of Toronto, Toronto, the Department of Medicine, University of Calgary, Calgary, AB (L.P.G.), the Department of Medicine, University of British Columbia, Vancouver (A.L.), and the Department of Medicine, University of Western Ontario, London (W.F.C.) - all in Canada; the Division of Rheumatology, Departments of Medicine and Biostatistics, Epidemiology, and Informatics, University of Pennsylvania, Philadelphia (P.A.M., C.A.M.); Royal Adelaide Hospital and the University of Adelaide, Adelaide (C.-A.P.), and the Australasian Kidney Trials Network, University of Queensland, Brisbane (C.M.H., D.R.) - all in Australia; Rigshospitalet University Hospital, Department of Nephrology, Copenhagen (W.M.S.); Assistance Publique-Hôpitaux de Paris, Hôpital Cochin, Université Paris Descartes, Paris (X.P., L.G.); the Faculty of Medicine, University of Miyazaki, Miyazaki (S.F.), and the Institute for Advancement of Clinical and Translational Science, Kyoto University Hospital, and the Clinical and Translational Research Center, University Hospital, Kyoto Prefectural University of Medicine, Kyoto (T.I.-I.) - all in Japan; Royal Berkshire Hospital, Reading (O.F.), the Institute of Clinical Sciences (L.H.) and the Birmingham Clinical Trials Unit, Institute of Applied Health Research (S.M., N.I.), University of Birmingham, Birmingham, the Royal Devon and Exeter NHS Foundation Trust, Exeter (L.S.), the Department of Medicine, Imperial College London (C.D.P.), and Guys and St. Thomas' NHS Foundation Trust (A.L.C.), London, and the Department of Medicine, University of Cambridge (B.B., E.B., D.R.W.J.), and Addenbrooke's Hospital (D.R.W.J.), Cambridge - all in the United Kingdom; Spedali Civili di Brescia, Università di Brescia, Brescia, Italy (G.G.); the Division of Pulmonary and Critical Care Medicine, Mayo Clinic, Rochester, MN (U.S.); the Department of Nephrology, General University Hospital, Charles University, Prague, Czech Republic (V.T.); the Renal Service, Waitemata District Health Board, and the Department of Medicine, University of Auckland, Auckland, New Zealand (J.R.Z.); Jagiellonian University Medical College, Krakow, Poland (W.S.); and the Primary Systemic Vasculitides Clinic, Instituto Nacional de Enfermedades Respiratorias, Mexico City (L.F.F.-S.).""}, {'ForeName': 'Shouichi', 'Initials': 'S', 'LastName': 'Fujimoto', 'Affiliation': ""From the Population Health Research Institute, McMaster University-Hamilton Health Sciences (M.W.), and the Departments of Medicine (M.W., N.K.) and Health Research Methods, Evidence, and Impact (M.W.), McMaster University, and St. Joseph's Healthcare (M.W., N.K., A.M.), Hamilton, ON, the Division of Nephrology and the Li Ka Shing Knowledge Institute, St. Michael's Hospital (R.W.), and the Department of Medicine (R.W.), the Vasculitis Clinic, Department of Rheumatology (C.P., S.C.), and Mount Sinai Hospital, Division of Rheumatology (C.P., S.C.), University of Toronto, Toronto, the Department of Medicine, University of Calgary, Calgary, AB (L.P.G.), the Department of Medicine, University of British Columbia, Vancouver (A.L.), and the Department of Medicine, University of Western Ontario, London (W.F.C.) - all in Canada; the Division of Rheumatology, Departments of Medicine and Biostatistics, Epidemiology, and Informatics, University of Pennsylvania, Philadelphia (P.A.M., C.A.M.); Royal Adelaide Hospital and the University of Adelaide, Adelaide (C.-A.P.), and the Australasian Kidney Trials Network, University of Queensland, Brisbane (C.M.H., D.R.) - all in Australia; Rigshospitalet University Hospital, Department of Nephrology, Copenhagen (W.M.S.); Assistance Publique-Hôpitaux de Paris, Hôpital Cochin, Université Paris Descartes, Paris (X.P., L.G.); the Faculty of Medicine, University of Miyazaki, Miyazaki (S.F.), and the Institute for Advancement of Clinical and Translational Science, Kyoto University Hospital, and the Clinical and Translational Research Center, University Hospital, Kyoto Prefectural University of Medicine, Kyoto (T.I.-I.) - all in Japan; Royal Berkshire Hospital, Reading (O.F.), the Institute of Clinical Sciences (L.H.) and the Birmingham Clinical Trials Unit, Institute of Applied Health Research (S.M., N.I.), University of Birmingham, Birmingham, the Royal Devon and Exeter NHS Foundation Trust, Exeter (L.S.), the Department of Medicine, Imperial College London (C.D.P.), and Guys and St. Thomas' NHS Foundation Trust (A.L.C.), London, and the Department of Medicine, University of Cambridge (B.B., E.B., D.R.W.J.), and Addenbrooke's Hospital (D.R.W.J.), Cambridge - all in the United Kingdom; Spedali Civili di Brescia, Università di Brescia, Brescia, Italy (G.G.); the Division of Pulmonary and Critical Care Medicine, Mayo Clinic, Rochester, MN (U.S.); the Department of Nephrology, General University Hospital, Charles University, Prague, Czech Republic (V.T.); the Renal Service, Waitemata District Health Board, and the Department of Medicine, University of Auckland, Auckland, New Zealand (J.R.Z.); Jagiellonian University Medical College, Krakow, Poland (W.S.); and the Primary Systemic Vasculitides Clinic, Instituto Nacional de Enfermedades Respiratorias, Mexico City (L.F.F.-S.).""}, {'ForeName': 'Carmel M', 'Initials': 'CM', 'LastName': 'Hawley', 'Affiliation': ""From the Population Health Research Institute, McMaster University-Hamilton Health Sciences (M.W.), and the Departments of Medicine (M.W., N.K.) and Health Research Methods, Evidence, and Impact (M.W.), McMaster University, and St. Joseph's Healthcare (M.W., N.K., A.M.), Hamilton, ON, the Division of Nephrology and the Li Ka Shing Knowledge Institute, St. Michael's Hospital (R.W.), and the Department of Medicine (R.W.), the Vasculitis Clinic, Department of Rheumatology (C.P., S.C.), and Mount Sinai Hospital, Division of Rheumatology (C.P., S.C.), University of Toronto, Toronto, the Department of Medicine, University of Calgary, Calgary, AB (L.P.G.), the Department of Medicine, University of British Columbia, Vancouver (A.L.), and the Department of Medicine, University of Western Ontario, London (W.F.C.) - all in Canada; the Division of Rheumatology, Departments of Medicine and Biostatistics, Epidemiology, and Informatics, University of Pennsylvania, Philadelphia (P.A.M., C.A.M.); Royal Adelaide Hospital and the University of Adelaide, Adelaide (C.-A.P.), and the Australasian Kidney Trials Network, University of Queensland, Brisbane (C.M.H., D.R.) - all in Australia; Rigshospitalet University Hospital, Department of Nephrology, Copenhagen (W.M.S.); Assistance Publique-Hôpitaux de Paris, Hôpital Cochin, Université Paris Descartes, Paris (X.P., L.G.); the Faculty of Medicine, University of Miyazaki, Miyazaki (S.F.), and the Institute for Advancement of Clinical and Translational Science, Kyoto University Hospital, and the Clinical and Translational Research Center, University Hospital, Kyoto Prefectural University of Medicine, Kyoto (T.I.-I.) - all in Japan; Royal Berkshire Hospital, Reading (O.F.), the Institute of Clinical Sciences (L.H.) and the Birmingham Clinical Trials Unit, Institute of Applied Health Research (S.M., N.I.), University of Birmingham, Birmingham, the Royal Devon and Exeter NHS Foundation Trust, Exeter (L.S.), the Department of Medicine, Imperial College London (C.D.P.), and Guys and St. Thomas' NHS Foundation Trust (A.L.C.), London, and the Department of Medicine, University of Cambridge (B.B., E.B., D.R.W.J.), and Addenbrooke's Hospital (D.R.W.J.), Cambridge - all in the United Kingdom; Spedali Civili di Brescia, Università di Brescia, Brescia, Italy (G.G.); the Division of Pulmonary and Critical Care Medicine, Mayo Clinic, Rochester, MN (U.S.); the Department of Nephrology, General University Hospital, Charles University, Prague, Czech Republic (V.T.); the Renal Service, Waitemata District Health Board, and the Department of Medicine, University of Auckland, Auckland, New Zealand (J.R.Z.); Jagiellonian University Medical College, Krakow, Poland (W.S.); and the Primary Systemic Vasculitides Clinic, Instituto Nacional de Enfermedades Respiratorias, Mexico City (L.F.F.-S.).""}, {'ForeName': 'Nader', 'Initials': 'N', 'LastName': 'Khalidi', 'Affiliation': ""From the Population Health Research Institute, McMaster University-Hamilton Health Sciences (M.W.), and the Departments of Medicine (M.W., N.K.) and Health Research Methods, Evidence, and Impact (M.W.), McMaster University, and St. Joseph's Healthcare (M.W., N.K., A.M.), Hamilton, ON, the Division of Nephrology and the Li Ka Shing Knowledge Institute, St. Michael's Hospital (R.W.), and the Department of Medicine (R.W.), the Vasculitis Clinic, Department of Rheumatology (C.P., S.C.), and Mount Sinai Hospital, Division of Rheumatology (C.P., S.C.), University of Toronto, Toronto, the Department of Medicine, University of Calgary, Calgary, AB (L.P.G.), the Department of Medicine, University of British Columbia, Vancouver (A.L.), and the Department of Medicine, University of Western Ontario, London (W.F.C.) - all in Canada; the Division of Rheumatology, Departments of Medicine and Biostatistics, Epidemiology, and Informatics, University of Pennsylvania, Philadelphia (P.A.M., C.A.M.); Royal Adelaide Hospital and the University of Adelaide, Adelaide (C.-A.P.), and the Australasian Kidney Trials Network, University of Queensland, Brisbane (C.M.H., D.R.) - all in Australia; Rigshospitalet University Hospital, Department of Nephrology, Copenhagen (W.M.S.); Assistance Publique-Hôpitaux de Paris, Hôpital Cochin, Université Paris Descartes, Paris (X.P., L.G.); the Faculty of Medicine, University of Miyazaki, Miyazaki (S.F.), and the Institute for Advancement of Clinical and Translational Science, Kyoto University Hospital, and the Clinical and Translational Research Center, University Hospital, Kyoto Prefectural University of Medicine, Kyoto (T.I.-I.) - all in Japan; Royal Berkshire Hospital, Reading (O.F.), the Institute of Clinical Sciences (L.H.) and the Birmingham Clinical Trials Unit, Institute of Applied Health Research (S.M., N.I.), University of Birmingham, Birmingham, the Royal Devon and Exeter NHS Foundation Trust, Exeter (L.S.), the Department of Medicine, Imperial College London (C.D.P.), and Guys and St. Thomas' NHS Foundation Trust (A.L.C.), London, and the Department of Medicine, University of Cambridge (B.B., E.B., D.R.W.J.), and Addenbrooke's Hospital (D.R.W.J.), Cambridge - all in the United Kingdom; Spedali Civili di Brescia, Università di Brescia, Brescia, Italy (G.G.); the Division of Pulmonary and Critical Care Medicine, Mayo Clinic, Rochester, MN (U.S.); the Department of Nephrology, General University Hospital, Charles University, Prague, Czech Republic (V.T.); the Renal Service, Waitemata District Health Board, and the Department of Medicine, University of Auckland, Auckland, New Zealand (J.R.Z.); Jagiellonian University Medical College, Krakow, Poland (W.S.); and the Primary Systemic Vasculitides Clinic, Instituto Nacional de Enfermedades Respiratorias, Mexico City (L.F.F.-S.).""}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Floßmann', 'Affiliation': ""From the Population Health Research Institute, McMaster University-Hamilton Health Sciences (M.W.), and the Departments of Medicine (M.W., N.K.) and Health Research Methods, Evidence, and Impact (M.W.), McMaster University, and St. Joseph's Healthcare (M.W., N.K., A.M.), Hamilton, ON, the Division of Nephrology and the Li Ka Shing Knowledge Institute, St. Michael's Hospital (R.W.), and the Department of Medicine (R.W.), the Vasculitis Clinic, Department of Rheumatology (C.P., S.C.), and Mount Sinai Hospital, Division of Rheumatology (C.P., S.C.), University of Toronto, Toronto, the Department of Medicine, University of Calgary, Calgary, AB (L.P.G.), the Department of Medicine, University of British Columbia, Vancouver (A.L.), and the Department of Medicine, University of Western Ontario, London (W.F.C.) - all in Canada; the Division of Rheumatology, Departments of Medicine and Biostatistics, Epidemiology, and Informatics, University of Pennsylvania, Philadelphia (P.A.M., C.A.M.); Royal Adelaide Hospital and the University of Adelaide, Adelaide (C.-A.P.), and the Australasian Kidney Trials Network, University of Queensland, Brisbane (C.M.H., D.R.) - all in Australia; Rigshospitalet University Hospital, Department of Nephrology, Copenhagen (W.M.S.); Assistance Publique-Hôpitaux de Paris, Hôpital Cochin, Université Paris Descartes, Paris (X.P., L.G.); the Faculty of Medicine, University of Miyazaki, Miyazaki (S.F.), and the Institute for Advancement of Clinical and Translational Science, Kyoto University Hospital, and the Clinical and Translational Research Center, University Hospital, Kyoto Prefectural University of Medicine, Kyoto (T.I.-I.) - all in Japan; Royal Berkshire Hospital, Reading (O.F.), the Institute of Clinical Sciences (L.H.) and the Birmingham Clinical Trials Unit, Institute of Applied Health Research (S.M., N.I.), University of Birmingham, Birmingham, the Royal Devon and Exeter NHS Foundation Trust, Exeter (L.S.), the Department of Medicine, Imperial College London (C.D.P.), and Guys and St. Thomas' NHS Foundation Trust (A.L.C.), London, and the Department of Medicine, University of Cambridge (B.B., E.B., D.R.W.J.), and Addenbrooke's Hospital (D.R.W.J.), Cambridge - all in the United Kingdom; Spedali Civili di Brescia, Università di Brescia, Brescia, Italy (G.G.); the Division of Pulmonary and Critical Care Medicine, Mayo Clinic, Rochester, MN (U.S.); the Department of Nephrology, General University Hospital, Charles University, Prague, Czech Republic (V.T.); the Renal Service, Waitemata District Health Board, and the Department of Medicine, University of Auckland, Auckland, New Zealand (J.R.Z.); Jagiellonian University Medical College, Krakow, Poland (W.S.); and the Primary Systemic Vasculitides Clinic, Instituto Nacional de Enfermedades Respiratorias, Mexico City (L.F.F.-S.).""}, {'ForeName': 'Ron', 'Initials': 'R', 'LastName': 'Wald', 'Affiliation': ""From the Population Health Research Institute, McMaster University-Hamilton Health Sciences (M.W.), and the Departments of Medicine (M.W., N.K.) and Health Research Methods, Evidence, and Impact (M.W.), McMaster University, and St. Joseph's Healthcare (M.W., N.K., A.M.), Hamilton, ON, the Division of Nephrology and the Li Ka Shing Knowledge Institute, St. Michael's Hospital (R.W.), and the Department of Medicine (R.W.), the Vasculitis Clinic, Department of Rheumatology (C.P., S.C.), and Mount Sinai Hospital, Division of Rheumatology (C.P., S.C.), University of Toronto, Toronto, the Department of Medicine, University of Calgary, Calgary, AB (L.P.G.), the Department of Medicine, University of British Columbia, Vancouver (A.L.), and the Department of Medicine, University of Western Ontario, London (W.F.C.) - all in Canada; the Division of Rheumatology, Departments of Medicine and Biostatistics, Epidemiology, and Informatics, University of Pennsylvania, Philadelphia (P.A.M., C.A.M.); Royal Adelaide Hospital and the University of Adelaide, Adelaide (C.-A.P.), and the Australasian Kidney Trials Network, University of Queensland, Brisbane (C.M.H., D.R.) - all in Australia; Rigshospitalet University Hospital, Department of Nephrology, Copenhagen (W.M.S.); Assistance Publique-Hôpitaux de Paris, Hôpital Cochin, Université Paris Descartes, Paris (X.P., L.G.); the Faculty of Medicine, University of Miyazaki, Miyazaki (S.F.), and the Institute for Advancement of Clinical and Translational Science, Kyoto University Hospital, and the Clinical and Translational Research Center, University Hospital, Kyoto Prefectural University of Medicine, Kyoto (T.I.-I.) - all in Japan; Royal Berkshire Hospital, Reading (O.F.), the Institute of Clinical Sciences (L.H.) and the Birmingham Clinical Trials Unit, Institute of Applied Health Research (S.M., N.I.), University of Birmingham, Birmingham, the Royal Devon and Exeter NHS Foundation Trust, Exeter (L.S.), the Department of Medicine, Imperial College London (C.D.P.), and Guys and St. Thomas' NHS Foundation Trust (A.L.C.), London, and the Department of Medicine, University of Cambridge (B.B., E.B., D.R.W.J.), and Addenbrooke's Hospital (D.R.W.J.), Cambridge - all in the United Kingdom; Spedali Civili di Brescia, Università di Brescia, Brescia, Italy (G.G.); the Division of Pulmonary and Critical Care Medicine, Mayo Clinic, Rochester, MN (U.S.); the Department of Nephrology, General University Hospital, Charles University, Prague, Czech Republic (V.T.); the Renal Service, Waitemata District Health Board, and the Department of Medicine, University of Auckland, Auckland, New Zealand (J.R.Z.); Jagiellonian University Medical College, Krakow, Poland (W.S.); and the Primary Systemic Vasculitides Clinic, Instituto Nacional de Enfermedades Respiratorias, Mexico City (L.F.F.-S.).""}, {'ForeName': 'Louis P', 'Initials': 'LP', 'LastName': 'Girard', 'Affiliation': ""From the Population Health Research Institute, McMaster University-Hamilton Health Sciences (M.W.), and the Departments of Medicine (M.W., N.K.) and Health Research Methods, Evidence, and Impact (M.W.), McMaster University, and St. Joseph's Healthcare (M.W., N.K., A.M.), Hamilton, ON, the Division of Nephrology and the Li Ka Shing Knowledge Institute, St. Michael's Hospital (R.W.), and the Department of Medicine (R.W.), the Vasculitis Clinic, Department of Rheumatology (C.P., S.C.), and Mount Sinai Hospital, Division of Rheumatology (C.P., S.C.), University of Toronto, Toronto, the Department of Medicine, University of Calgary, Calgary, AB (L.P.G.), the Department of Medicine, University of British Columbia, Vancouver (A.L.), and the Department of Medicine, University of Western Ontario, London (W.F.C.) - all in Canada; the Division of Rheumatology, Departments of Medicine and Biostatistics, Epidemiology, and Informatics, University of Pennsylvania, Philadelphia (P.A.M., C.A.M.); Royal Adelaide Hospital and the University of Adelaide, Adelaide (C.-A.P.), and the Australasian Kidney Trials Network, University of Queensland, Brisbane (C.M.H., D.R.) - all in Australia; Rigshospitalet University Hospital, Department of Nephrology, Copenhagen (W.M.S.); Assistance Publique-Hôpitaux de Paris, Hôpital Cochin, Université Paris Descartes, Paris (X.P., L.G.); the Faculty of Medicine, University of Miyazaki, Miyazaki (S.F.), and the Institute for Advancement of Clinical and Translational Science, Kyoto University Hospital, and the Clinical and Translational Research Center, University Hospital, Kyoto Prefectural University of Medicine, Kyoto (T.I.-I.) - all in Japan; Royal Berkshire Hospital, Reading (O.F.), the Institute of Clinical Sciences (L.H.) and the Birmingham Clinical Trials Unit, Institute of Applied Health Research (S.M., N.I.), University of Birmingham, Birmingham, the Royal Devon and Exeter NHS Foundation Trust, Exeter (L.S.), the Department of Medicine, Imperial College London (C.D.P.), and Guys and St. Thomas' NHS Foundation Trust (A.L.C.), London, and the Department of Medicine, University of Cambridge (B.B., E.B., D.R.W.J.), and Addenbrooke's Hospital (D.R.W.J.), Cambridge - all in the United Kingdom; Spedali Civili di Brescia, Università di Brescia, Brescia, Italy (G.G.); the Division of Pulmonary and Critical Care Medicine, Mayo Clinic, Rochester, MN (U.S.); the Department of Nephrology, General University Hospital, Charles University, Prague, Czech Republic (V.T.); the Renal Service, Waitemata District Health Board, and the Department of Medicine, University of Auckland, Auckland, New Zealand (J.R.Z.); Jagiellonian University Medical College, Krakow, Poland (W.S.); and the Primary Systemic Vasculitides Clinic, Instituto Nacional de Enfermedades Respiratorias, Mexico City (L.F.F.-S.).""}, {'ForeName': 'Adeera', 'Initials': 'A', 'LastName': 'Levin', 'Affiliation': ""From the Population Health Research Institute, McMaster University-Hamilton Health Sciences (M.W.), and the Departments of Medicine (M.W., N.K.) and Health Research Methods, Evidence, and Impact (M.W.), McMaster University, and St. Joseph's Healthcare (M.W., N.K., A.M.), Hamilton, ON, the Division of Nephrology and the Li Ka Shing Knowledge Institute, St. Michael's Hospital (R.W.), and the Department of Medicine (R.W.), the Vasculitis Clinic, Department of Rheumatology (C.P., S.C.), and Mount Sinai Hospital, Division of Rheumatology (C.P., S.C.), University of Toronto, Toronto, the Department of Medicine, University of Calgary, Calgary, AB (L.P.G.), the Department of Medicine, University of British Columbia, Vancouver (A.L.), and the Department of Medicine, University of Western Ontario, London (W.F.C.) - all in Canada; the Division of Rheumatology, Departments of Medicine and Biostatistics, Epidemiology, and Informatics, University of Pennsylvania, Philadelphia (P.A.M., C.A.M.); Royal Adelaide Hospital and the University of Adelaide, Adelaide (C.-A.P.), and the Australasian Kidney Trials Network, University of Queensland, Brisbane (C.M.H., D.R.) - all in Australia; Rigshospitalet University Hospital, Department of Nephrology, Copenhagen (W.M.S.); Assistance Publique-Hôpitaux de Paris, Hôpital Cochin, Université Paris Descartes, Paris (X.P., L.G.); the Faculty of Medicine, University of Miyazaki, Miyazaki (S.F.), and the Institute for Advancement of Clinical and Translational Science, Kyoto University Hospital, and the Clinical and Translational Research Center, University Hospital, Kyoto Prefectural University of Medicine, Kyoto (T.I.-I.) - all in Japan; Royal Berkshire Hospital, Reading (O.F.), the Institute of Clinical Sciences (L.H.) and the Birmingham Clinical Trials Unit, Institute of Applied Health Research (S.M., N.I.), University of Birmingham, Birmingham, the Royal Devon and Exeter NHS Foundation Trust, Exeter (L.S.), the Department of Medicine, Imperial College London (C.D.P.), and Guys and St. Thomas' NHS Foundation Trust (A.L.C.), London, and the Department of Medicine, University of Cambridge (B.B., E.B., D.R.W.J.), and Addenbrooke's Hospital (D.R.W.J.), Cambridge - all in the United Kingdom; Spedali Civili di Brescia, Università di Brescia, Brescia, Italy (G.G.); the Division of Pulmonary and Critical Care Medicine, Mayo Clinic, Rochester, MN (U.S.); the Department of Nephrology, General University Hospital, Charles University, Prague, Czech Republic (V.T.); the Renal Service, Waitemata District Health Board, and the Department of Medicine, University of Auckland, Auckland, New Zealand (J.R.Z.); Jagiellonian University Medical College, Krakow, Poland (W.S.); and the Primary Systemic Vasculitides Clinic, Instituto Nacional de Enfermedades Respiratorias, Mexico City (L.F.F.-S.).""}, {'ForeName': 'Gina', 'Initials': 'G', 'LastName': 'Gregorini', 'Affiliation': ""From the Population Health Research Institute, McMaster University-Hamilton Health Sciences (M.W.), and the Departments of Medicine (M.W., N.K.) and Health Research Methods, Evidence, and Impact (M.W.), McMaster University, and St. Joseph's Healthcare (M.W., N.K., A.M.), Hamilton, ON, the Division of Nephrology and the Li Ka Shing Knowledge Institute, St. Michael's Hospital (R.W.), and the Department of Medicine (R.W.), the Vasculitis Clinic, Department of Rheumatology (C.P., S.C.), and Mount Sinai Hospital, Division of Rheumatology (C.P., S.C.), University of Toronto, Toronto, the Department of Medicine, University of Calgary, Calgary, AB (L.P.G.), the Department of Medicine, University of British Columbia, Vancouver (A.L.), and the Department of Medicine, University of Western Ontario, London (W.F.C.) - all in Canada; the Division of Rheumatology, Departments of Medicine and Biostatistics, Epidemiology, and Informatics, University of Pennsylvania, Philadelphia (P.A.M., C.A.M.); Royal Adelaide Hospital and the University of Adelaide, Adelaide (C.-A.P.), and the Australasian Kidney Trials Network, University of Queensland, Brisbane (C.M.H., D.R.) - all in Australia; Rigshospitalet University Hospital, Department of Nephrology, Copenhagen (W.M.S.); Assistance Publique-Hôpitaux de Paris, Hôpital Cochin, Université Paris Descartes, Paris (X.P., L.G.); the Faculty of Medicine, University of Miyazaki, Miyazaki (S.F.), and the Institute for Advancement of Clinical and Translational Science, Kyoto University Hospital, and the Clinical and Translational Research Center, University Hospital, Kyoto Prefectural University of Medicine, Kyoto (T.I.-I.) - all in Japan; Royal Berkshire Hospital, Reading (O.F.), the Institute of Clinical Sciences (L.H.) and the Birmingham Clinical Trials Unit, Institute of Applied Health Research (S.M., N.I.), University of Birmingham, Birmingham, the Royal Devon and Exeter NHS Foundation Trust, Exeter (L.S.), the Department of Medicine, Imperial College London (C.D.P.), and Guys and St. Thomas' NHS Foundation Trust (A.L.C.), London, and the Department of Medicine, University of Cambridge (B.B., E.B., D.R.W.J.), and Addenbrooke's Hospital (D.R.W.J.), Cambridge - all in the United Kingdom; Spedali Civili di Brescia, Università di Brescia, Brescia, Italy (G.G.); the Division of Pulmonary and Critical Care Medicine, Mayo Clinic, Rochester, MN (U.S.); the Department of Nephrology, General University Hospital, Charles University, Prague, Czech Republic (V.T.); the Renal Service, Waitemata District Health Board, and the Department of Medicine, University of Auckland, Auckland, New Zealand (J.R.Z.); Jagiellonian University Medical College, Krakow, Poland (W.S.); and the Primary Systemic Vasculitides Clinic, Instituto Nacional de Enfermedades Respiratorias, Mexico City (L.F.F.-S.).""}, {'ForeName': 'Lorraine', 'Initials': 'L', 'LastName': 'Harper', 'Affiliation': ""From the Population Health Research Institute, McMaster University-Hamilton Health Sciences (M.W.), and the Departments of Medicine (M.W., N.K.) and Health Research Methods, Evidence, and Impact (M.W.), McMaster University, and St. Joseph's Healthcare (M.W., N.K., A.M.), Hamilton, ON, the Division of Nephrology and the Li Ka Shing Knowledge Institute, St. Michael's Hospital (R.W.), and the Department of Medicine (R.W.), the Vasculitis Clinic, Department of Rheumatology (C.P., S.C.), and Mount Sinai Hospital, Division of Rheumatology (C.P., S.C.), University of Toronto, Toronto, the Department of Medicine, University of Calgary, Calgary, AB (L.P.G.), the Department of Medicine, University of British Columbia, Vancouver (A.L.), and the Department of Medicine, University of Western Ontario, London (W.F.C.) - all in Canada; the Division of Rheumatology, Departments of Medicine and Biostatistics, Epidemiology, and Informatics, University of Pennsylvania, Philadelphia (P.A.M., C.A.M.); Royal Adelaide Hospital and the University of Adelaide, Adelaide (C.-A.P.), and the Australasian Kidney Trials Network, University of Queensland, Brisbane (C.M.H., D.R.) - all in Australia; Rigshospitalet University Hospital, Department of Nephrology, Copenhagen (W.M.S.); Assistance Publique-Hôpitaux de Paris, Hôpital Cochin, Université Paris Descartes, Paris (X.P., L.G.); the Faculty of Medicine, University of Miyazaki, Miyazaki (S.F.), and the Institute for Advancement of Clinical and Translational Science, Kyoto University Hospital, and the Clinical and Translational Research Center, University Hospital, Kyoto Prefectural University of Medicine, Kyoto (T.I.-I.) - all in Japan; Royal Berkshire Hospital, Reading (O.F.), the Institute of Clinical Sciences (L.H.) and the Birmingham Clinical Trials Unit, Institute of Applied Health Research (S.M., N.I.), University of Birmingham, Birmingham, the Royal Devon and Exeter NHS Foundation Trust, Exeter (L.S.), the Department of Medicine, Imperial College London (C.D.P.), and Guys and St. Thomas' NHS Foundation Trust (A.L.C.), London, and the Department of Medicine, University of Cambridge (B.B., E.B., D.R.W.J.), and Addenbrooke's Hospital (D.R.W.J.), Cambridge - all in the United Kingdom; Spedali Civili di Brescia, Università di Brescia, Brescia, Italy (G.G.); the Division of Pulmonary and Critical Care Medicine, Mayo Clinic, Rochester, MN (U.S.); the Department of Nephrology, General University Hospital, Charles University, Prague, Czech Republic (V.T.); the Renal Service, Waitemata District Health Board, and the Department of Medicine, University of Auckland, Auckland, New Zealand (J.R.Z.); Jagiellonian University Medical College, Krakow, Poland (W.S.); and the Primary Systemic Vasculitides Clinic, Instituto Nacional de Enfermedades Respiratorias, Mexico City (L.F.F.-S.).""}, {'ForeName': 'William F', 'Initials': 'WF', 'LastName': 'Clark', 'Affiliation': ""From the Population Health Research Institute, McMaster University-Hamilton Health Sciences (M.W.), and the Departments of Medicine (M.W., N.K.) and Health Research Methods, Evidence, and Impact (M.W.), McMaster University, and St. Joseph's Healthcare (M.W., N.K., A.M.), Hamilton, ON, the Division of Nephrology and the Li Ka Shing Knowledge Institute, St. Michael's Hospital (R.W.), and the Department of Medicine (R.W.), the Vasculitis Clinic, Department of Rheumatology (C.P., S.C.), and Mount Sinai Hospital, Division of Rheumatology (C.P., S.C.), University of Toronto, Toronto, the Department of Medicine, University of Calgary, Calgary, AB (L.P.G.), the Department of Medicine, University of British Columbia, Vancouver (A.L.), and the Department of Medicine, University of Western Ontario, London (W.F.C.) - all in Canada; the Division of Rheumatology, Departments of Medicine and Biostatistics, Epidemiology, and Informatics, University of Pennsylvania, Philadelphia (P.A.M., C.A.M.); Royal Adelaide Hospital and the University of Adelaide, Adelaide (C.-A.P.), and the Australasian Kidney Trials Network, University of Queensland, Brisbane (C.M.H., D.R.) - all in Australia; Rigshospitalet University Hospital, Department of Nephrology, Copenhagen (W.M.S.); Assistance Publique-Hôpitaux de Paris, Hôpital Cochin, Université Paris Descartes, Paris (X.P., L.G.); the Faculty of Medicine, University of Miyazaki, Miyazaki (S.F.), and the Institute for Advancement of Clinical and Translational Science, Kyoto University Hospital, and the Clinical and Translational Research Center, University Hospital, Kyoto Prefectural University of Medicine, Kyoto (T.I.-I.) - all in Japan; Royal Berkshire Hospital, Reading (O.F.), the Institute of Clinical Sciences (L.H.) and the Birmingham Clinical Trials Unit, Institute of Applied Health Research (S.M., N.I.), University of Birmingham, Birmingham, the Royal Devon and Exeter NHS Foundation Trust, Exeter (L.S.), the Department of Medicine, Imperial College London (C.D.P.), and Guys and St. Thomas' NHS Foundation Trust (A.L.C.), London, and the Department of Medicine, University of Cambridge (B.B., E.B., D.R.W.J.), and Addenbrooke's Hospital (D.R.W.J.), Cambridge - all in the United Kingdom; Spedali Civili di Brescia, Università di Brescia, Brescia, Italy (G.G.); the Division of Pulmonary and Critical Care Medicine, Mayo Clinic, Rochester, MN (U.S.); the Department of Nephrology, General University Hospital, Charles University, Prague, Czech Republic (V.T.); the Renal Service, Waitemata District Health Board, and the Department of Medicine, University of Auckland, Auckland, New Zealand (J.R.Z.); Jagiellonian University Medical College, Krakow, Poland (W.S.); and the Primary Systemic Vasculitides Clinic, Instituto Nacional de Enfermedades Respiratorias, Mexico City (L.F.F.-S.).""}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Pagnoux', 'Affiliation': ""From the Population Health Research Institute, McMaster University-Hamilton Health Sciences (M.W.), and the Departments of Medicine (M.W., N.K.) and Health Research Methods, Evidence, and Impact (M.W.), McMaster University, and St. Joseph's Healthcare (M.W., N.K., A.M.), Hamilton, ON, the Division of Nephrology and the Li Ka Shing Knowledge Institute, St. Michael's Hospital (R.W.), and the Department of Medicine (R.W.), the Vasculitis Clinic, Department of Rheumatology (C.P., S.C.), and Mount Sinai Hospital, Division of Rheumatology (C.P., S.C.), University of Toronto, Toronto, the Department of Medicine, University of Calgary, Calgary, AB (L.P.G.), the Department of Medicine, University of British Columbia, Vancouver (A.L.), and the Department of Medicine, University of Western Ontario, London (W.F.C.) - all in Canada; the Division of Rheumatology, Departments of Medicine and Biostatistics, Epidemiology, and Informatics, University of Pennsylvania, Philadelphia (P.A.M., C.A.M.); Royal Adelaide Hospital and the University of Adelaide, Adelaide (C.-A.P.), and the Australasian Kidney Trials Network, University of Queensland, Brisbane (C.M.H., D.R.) - all in Australia; Rigshospitalet University Hospital, Department of Nephrology, Copenhagen (W.M.S.); Assistance Publique-Hôpitaux de Paris, Hôpital Cochin, Université Paris Descartes, Paris (X.P., L.G.); the Faculty of Medicine, University of Miyazaki, Miyazaki (S.F.), and the Institute for Advancement of Clinical and Translational Science, Kyoto University Hospital, and the Clinical and Translational Research Center, University Hospital, Kyoto Prefectural University of Medicine, Kyoto (T.I.-I.) - all in Japan; Royal Berkshire Hospital, Reading (O.F.), the Institute of Clinical Sciences (L.H.) and the Birmingham Clinical Trials Unit, Institute of Applied Health Research (S.M., N.I.), University of Birmingham, Birmingham, the Royal Devon and Exeter NHS Foundation Trust, Exeter (L.S.), the Department of Medicine, Imperial College London (C.D.P.), and Guys and St. Thomas' NHS Foundation Trust (A.L.C.), London, and the Department of Medicine, University of Cambridge (B.B., E.B., D.R.W.J.), and Addenbrooke's Hospital (D.R.W.J.), Cambridge - all in the United Kingdom; Spedali Civili di Brescia, Università di Brescia, Brescia, Italy (G.G.); the Division of Pulmonary and Critical Care Medicine, Mayo Clinic, Rochester, MN (U.S.); the Department of Nephrology, General University Hospital, Charles University, Prague, Czech Republic (V.T.); the Renal Service, Waitemata District Health Board, and the Department of Medicine, University of Auckland, Auckland, New Zealand (J.R.Z.); Jagiellonian University Medical College, Krakow, Poland (W.S.); and the Primary Systemic Vasculitides Clinic, Instituto Nacional de Enfermedades Respiratorias, Mexico City (L.F.F.-S.).""}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Specks', 'Affiliation': ""From the Population Health Research Institute, McMaster University-Hamilton Health Sciences (M.W.), and the Departments of Medicine (M.W., N.K.) and Health Research Methods, Evidence, and Impact (M.W.), McMaster University, and St. Joseph's Healthcare (M.W., N.K., A.M.), Hamilton, ON, the Division of Nephrology and the Li Ka Shing Knowledge Institute, St. Michael's Hospital (R.W.), and the Department of Medicine (R.W.), the Vasculitis Clinic, Department of Rheumatology (C.P., S.C.), and Mount Sinai Hospital, Division of Rheumatology (C.P., S.C.), University of Toronto, Toronto, the Department of Medicine, University of Calgary, Calgary, AB (L.P.G.), the Department of Medicine, University of British Columbia, Vancouver (A.L.), and the Department of Medicine, University of Western Ontario, London (W.F.C.) - all in Canada; the Division of Rheumatology, Departments of Medicine and Biostatistics, Epidemiology, and Informatics, University of Pennsylvania, Philadelphia (P.A.M., C.A.M.); Royal Adelaide Hospital and the University of Adelaide, Adelaide (C.-A.P.), and the Australasian Kidney Trials Network, University of Queensland, Brisbane (C.M.H., D.R.) - all in Australia; Rigshospitalet University Hospital, Department of Nephrology, Copenhagen (W.M.S.); Assistance Publique-Hôpitaux de Paris, Hôpital Cochin, Université Paris Descartes, Paris (X.P., L.G.); the Faculty of Medicine, University of Miyazaki, Miyazaki (S.F.), and the Institute for Advancement of Clinical and Translational Science, Kyoto University Hospital, and the Clinical and Translational Research Center, University Hospital, Kyoto Prefectural University of Medicine, Kyoto (T.I.-I.) - all in Japan; Royal Berkshire Hospital, Reading (O.F.), the Institute of Clinical Sciences (L.H.) and the Birmingham Clinical Trials Unit, Institute of Applied Health Research (S.M., N.I.), University of Birmingham, Birmingham, the Royal Devon and Exeter NHS Foundation Trust, Exeter (L.S.), the Department of Medicine, Imperial College London (C.D.P.), and Guys and St. Thomas' NHS Foundation Trust (A.L.C.), London, and the Department of Medicine, University of Cambridge (B.B., E.B., D.R.W.J.), and Addenbrooke's Hospital (D.R.W.J.), Cambridge - all in the United Kingdom; Spedali Civili di Brescia, Università di Brescia, Brescia, Italy (G.G.); the Division of Pulmonary and Critical Care Medicine, Mayo Clinic, Rochester, MN (U.S.); the Department of Nephrology, General University Hospital, Charles University, Prague, Czech Republic (V.T.); the Renal Service, Waitemata District Health Board, and the Department of Medicine, University of Auckland, Auckland, New Zealand (J.R.Z.); Jagiellonian University Medical College, Krakow, Poland (W.S.); and the Primary Systemic Vasculitides Clinic, Instituto Nacional de Enfermedades Respiratorias, Mexico City (L.F.F.-S.).""}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Smyth', 'Affiliation': ""From the Population Health Research Institute, McMaster University-Hamilton Health Sciences (M.W.), and the Departments of Medicine (M.W., N.K.) and Health Research Methods, Evidence, and Impact (M.W.), McMaster University, and St. Joseph's Healthcare (M.W., N.K., A.M.), Hamilton, ON, the Division of Nephrology and the Li Ka Shing Knowledge Institute, St. Michael's Hospital (R.W.), and the Department of Medicine (R.W.), the Vasculitis Clinic, Department of Rheumatology (C.P., S.C.), and Mount Sinai Hospital, Division of Rheumatology (C.P., S.C.), University of Toronto, Toronto, the Department of Medicine, University of Calgary, Calgary, AB (L.P.G.), the Department of Medicine, University of British Columbia, Vancouver (A.L.), and the Department of Medicine, University of Western Ontario, London (W.F.C.) - all in Canada; the Division of Rheumatology, Departments of Medicine and Biostatistics, Epidemiology, and Informatics, University of Pennsylvania, Philadelphia (P.A.M., C.A.M.); Royal Adelaide Hospital and the University of Adelaide, Adelaide (C.-A.P.), and the Australasian Kidney Trials Network, University of Queensland, Brisbane (C.M.H., D.R.) - all in Australia; Rigshospitalet University Hospital, Department of Nephrology, Copenhagen (W.M.S.); Assistance Publique-Hôpitaux de Paris, Hôpital Cochin, Université Paris Descartes, Paris (X.P., L.G.); the Faculty of Medicine, University of Miyazaki, Miyazaki (S.F.), and the Institute for Advancement of Clinical and Translational Science, Kyoto University Hospital, and the Clinical and Translational Research Center, University Hospital, Kyoto Prefectural University of Medicine, Kyoto (T.I.-I.) - all in Japan; Royal Berkshire Hospital, Reading (O.F.), the Institute of Clinical Sciences (L.H.) and the Birmingham Clinical Trials Unit, Institute of Applied Health Research (S.M., N.I.), University of Birmingham, Birmingham, the Royal Devon and Exeter NHS Foundation Trust, Exeter (L.S.), the Department of Medicine, Imperial College London (C.D.P.), and Guys and St. Thomas' NHS Foundation Trust (A.L.C.), London, and the Department of Medicine, University of Cambridge (B.B., E.B., D.R.W.J.), and Addenbrooke's Hospital (D.R.W.J.), Cambridge - all in the United Kingdom; Spedali Civili di Brescia, Università di Brescia, Brescia, Italy (G.G.); the Division of Pulmonary and Critical Care Medicine, Mayo Clinic, Rochester, MN (U.S.); the Department of Nephrology, General University Hospital, Charles University, Prague, Czech Republic (V.T.); the Renal Service, Waitemata District Health Board, and the Department of Medicine, University of Auckland, Auckland, New Zealand (J.R.Z.); Jagiellonian University Medical College, Krakow, Poland (W.S.); and the Primary Systemic Vasculitides Clinic, Instituto Nacional de Enfermedades Respiratorias, Mexico City (L.F.F.-S.).""}, {'ForeName': 'Vladimir', 'Initials': 'V', 'LastName': 'Tesar', 'Affiliation': ""From the Population Health Research Institute, McMaster University-Hamilton Health Sciences (M.W.), and the Departments of Medicine (M.W., N.K.) and Health Research Methods, Evidence, and Impact (M.W.), McMaster University, and St. Joseph's Healthcare (M.W., N.K., A.M.), Hamilton, ON, the Division of Nephrology and the Li Ka Shing Knowledge Institute, St. Michael's Hospital (R.W.), and the Department of Medicine (R.W.), the Vasculitis Clinic, Department of Rheumatology (C.P., S.C.), and Mount Sinai Hospital, Division of Rheumatology (C.P., S.C.), University of Toronto, Toronto, the Department of Medicine, University of Calgary, Calgary, AB (L.P.G.), the Department of Medicine, University of British Columbia, Vancouver (A.L.), and the Department of Medicine, University of Western Ontario, London (W.F.C.) - all in Canada; the Division of Rheumatology, Departments of Medicine and Biostatistics, Epidemiology, and Informatics, University of Pennsylvania, Philadelphia (P.A.M., C.A.M.); Royal Adelaide Hospital and the University of Adelaide, Adelaide (C.-A.P.), and the Australasian Kidney Trials Network, University of Queensland, Brisbane (C.M.H., D.R.) - all in Australia; Rigshospitalet University Hospital, Department of Nephrology, Copenhagen (W.M.S.); Assistance Publique-Hôpitaux de Paris, Hôpital Cochin, Université Paris Descartes, Paris (X.P., L.G.); the Faculty of Medicine, University of Miyazaki, Miyazaki (S.F.), and the Institute for Advancement of Clinical and Translational Science, Kyoto University Hospital, and the Clinical and Translational Research Center, University Hospital, Kyoto Prefectural University of Medicine, Kyoto (T.I.-I.) - all in Japan; Royal Berkshire Hospital, Reading (O.F.), the Institute of Clinical Sciences (L.H.) and the Birmingham Clinical Trials Unit, Institute of Applied Health Research (S.M., N.I.), University of Birmingham, Birmingham, the Royal Devon and Exeter NHS Foundation Trust, Exeter (L.S.), the Department of Medicine, Imperial College London (C.D.P.), and Guys and St. Thomas' NHS Foundation Trust (A.L.C.), London, and the Department of Medicine, University of Cambridge (B.B., E.B., D.R.W.J.), and Addenbrooke's Hospital (D.R.W.J.), Cambridge - all in the United Kingdom; Spedali Civili di Brescia, Università di Brescia, Brescia, Italy (G.G.); the Division of Pulmonary and Critical Care Medicine, Mayo Clinic, Rochester, MN (U.S.); the Department of Nephrology, General University Hospital, Charles University, Prague, Czech Republic (V.T.); the Renal Service, Waitemata District Health Board, and the Department of Medicine, University of Auckland, Auckland, New Zealand (J.R.Z.); Jagiellonian University Medical College, Krakow, Poland (W.S.); and the Primary Systemic Vasculitides Clinic, Instituto Nacional de Enfermedades Respiratorias, Mexico City (L.F.F.-S.).""}, {'ForeName': 'Toshiko', 'Initials': 'T', 'LastName': 'Ito-Ihara', 'Affiliation': ""From the Population Health Research Institute, McMaster University-Hamilton Health Sciences (M.W.), and the Departments of Medicine (M.W., N.K.) and Health Research Methods, Evidence, and Impact (M.W.), McMaster University, and St. Joseph's Healthcare (M.W., N.K., A.M.), Hamilton, ON, the Division of Nephrology and the Li Ka Shing Knowledge Institute, St. Michael's Hospital (R.W.), and the Department of Medicine (R.W.), the Vasculitis Clinic, Department of Rheumatology (C.P., S.C.), and Mount Sinai Hospital, Division of Rheumatology (C.P., S.C.), University of Toronto, Toronto, the Department of Medicine, University of Calgary, Calgary, AB (L.P.G.), the Department of Medicine, University of British Columbia, Vancouver (A.L.), and the Department of Medicine, University of Western Ontario, London (W.F.C.) - all in Canada; the Division of Rheumatology, Departments of Medicine and Biostatistics, Epidemiology, and Informatics, University of Pennsylvania, Philadelphia (P.A.M., C.A.M.); Royal Adelaide Hospital and the University of Adelaide, Adelaide (C.-A.P.), and the Australasian Kidney Trials Network, University of Queensland, Brisbane (C.M.H., D.R.) - all in Australia; Rigshospitalet University Hospital, Department of Nephrology, Copenhagen (W.M.S.); Assistance Publique-Hôpitaux de Paris, Hôpital Cochin, Université Paris Descartes, Paris (X.P., L.G.); the Faculty of Medicine, University of Miyazaki, Miyazaki (S.F.), and the Institute for Advancement of Clinical and Translational Science, Kyoto University Hospital, and the Clinical and Translational Research Center, University Hospital, Kyoto Prefectural University of Medicine, Kyoto (T.I.-I.) - all in Japan; Royal Berkshire Hospital, Reading (O.F.), the Institute of Clinical Sciences (L.H.) and the Birmingham Clinical Trials Unit, Institute of Applied Health Research (S.M., N.I.), University of Birmingham, Birmingham, the Royal Devon and Exeter NHS Foundation Trust, Exeter (L.S.), the Department of Medicine, Imperial College London (C.D.P.), and Guys and St. Thomas' NHS Foundation Trust (A.L.C.), London, and the Department of Medicine, University of Cambridge (B.B., E.B., D.R.W.J.), and Addenbrooke's Hospital (D.R.W.J.), Cambridge - all in the United Kingdom; Spedali Civili di Brescia, Università di Brescia, Brescia, Italy (G.G.); the Division of Pulmonary and Critical Care Medicine, Mayo Clinic, Rochester, MN (U.S.); the Department of Nephrology, General University Hospital, Charles University, Prague, Czech Republic (V.T.); the Renal Service, Waitemata District Health Board, and the Department of Medicine, University of Auckland, Auckland, New Zealand (J.R.Z.); Jagiellonian University Medical College, Krakow, Poland (W.S.); and the Primary Systemic Vasculitides Clinic, Instituto Nacional de Enfermedades Respiratorias, Mexico City (L.F.F.-S.).""}, {'ForeName': 'Janak Rashme', 'Initials': 'JR', 'LastName': 'de Zoysa', 'Affiliation': ""From the Population Health Research Institute, McMaster University-Hamilton Health Sciences (M.W.), and the Departments of Medicine (M.W., N.K.) and Health Research Methods, Evidence, and Impact (M.W.), McMaster University, and St. Joseph's Healthcare (M.W., N.K., A.M.), Hamilton, ON, the Division of Nephrology and the Li Ka Shing Knowledge Institute, St. Michael's Hospital (R.W.), and the Department of Medicine (R.W.), the Vasculitis Clinic, Department of Rheumatology (C.P., S.C.), and Mount Sinai Hospital, Division of Rheumatology (C.P., S.C.), University of Toronto, Toronto, the Department of Medicine, University of Calgary, Calgary, AB (L.P.G.), the Department of Medicine, University of British Columbia, Vancouver (A.L.), and the Department of Medicine, University of Western Ontario, London (W.F.C.) - all in Canada; the Division of Rheumatology, Departments of Medicine and Biostatistics, Epidemiology, and Informatics, University of Pennsylvania, Philadelphia (P.A.M., C.A.M.); Royal Adelaide Hospital and the University of Adelaide, Adelaide (C.-A.P.), and the Australasian Kidney Trials Network, University of Queensland, Brisbane (C.M.H., D.R.) - all in Australia; Rigshospitalet University Hospital, Department of Nephrology, Copenhagen (W.M.S.); Assistance Publique-Hôpitaux de Paris, Hôpital Cochin, Université Paris Descartes, Paris (X.P., L.G.); the Faculty of Medicine, University of Miyazaki, Miyazaki (S.F.), and the Institute for Advancement of Clinical and Translational Science, Kyoto University Hospital, and the Clinical and Translational Research Center, University Hospital, Kyoto Prefectural University of Medicine, Kyoto (T.I.-I.) - all in Japan; Royal Berkshire Hospital, Reading (O.F.), the Institute of Clinical Sciences (L.H.) and the Birmingham Clinical Trials Unit, Institute of Applied Health Research (S.M., N.I.), University of Birmingham, Birmingham, the Royal Devon and Exeter NHS Foundation Trust, Exeter (L.S.), the Department of Medicine, Imperial College London (C.D.P.), and Guys and St. Thomas' NHS Foundation Trust (A.L.C.), London, and the Department of Medicine, University of Cambridge (B.B., E.B., D.R.W.J.), and Addenbrooke's Hospital (D.R.W.J.), Cambridge - all in the United Kingdom; Spedali Civili di Brescia, Università di Brescia, Brescia, Italy (G.G.); the Division of Pulmonary and Critical Care Medicine, Mayo Clinic, Rochester, MN (U.S.); the Department of Nephrology, General University Hospital, Charles University, Prague, Czech Republic (V.T.); the Renal Service, Waitemata District Health Board, and the Department of Medicine, University of Auckland, Auckland, New Zealand (J.R.Z.); Jagiellonian University Medical College, Krakow, Poland (W.S.); and the Primary Systemic Vasculitides Clinic, Instituto Nacional de Enfermedades Respiratorias, Mexico City (L.F.F.-S.).""}, {'ForeName': 'Wojciech', 'Initials': 'W', 'LastName': 'Szczeklik', 'Affiliation': ""From the Population Health Research Institute, McMaster University-Hamilton Health Sciences (M.W.), and the Departments of Medicine (M.W., N.K.) and Health Research Methods, Evidence, and Impact (M.W.), McMaster University, and St. Joseph's Healthcare (M.W., N.K., A.M.), Hamilton, ON, the Division of Nephrology and the Li Ka Shing Knowledge Institute, St. Michael's Hospital (R.W.), and the Department of Medicine (R.W.), the Vasculitis Clinic, Department of Rheumatology (C.P., S.C.), and Mount Sinai Hospital, Division of Rheumatology (C.P., S.C.), University of Toronto, Toronto, the Department of Medicine, University of Calgary, Calgary, AB (L.P.G.), the Department of Medicine, University of British Columbia, Vancouver (A.L.), and the Department of Medicine, University of Western Ontario, London (W.F.C.) - all in Canada; the Division of Rheumatology, Departments of Medicine and Biostatistics, Epidemiology, and Informatics, University of Pennsylvania, Philadelphia (P.A.M., C.A.M.); Royal Adelaide Hospital and the University of Adelaide, Adelaide (C.-A.P.), and the Australasian Kidney Trials Network, University of Queensland, Brisbane (C.M.H., D.R.) - all in Australia; Rigshospitalet University Hospital, Department of Nephrology, Copenhagen (W.M.S.); Assistance Publique-Hôpitaux de Paris, Hôpital Cochin, Université Paris Descartes, Paris (X.P., L.G.); the Faculty of Medicine, University of Miyazaki, Miyazaki (S.F.), and the Institute for Advancement of Clinical and Translational Science, Kyoto University Hospital, and the Clinical and Translational Research Center, University Hospital, Kyoto Prefectural University of Medicine, Kyoto (T.I.-I.) - all in Japan; Royal Berkshire Hospital, Reading (O.F.), the Institute of Clinical Sciences (L.H.) and the Birmingham Clinical Trials Unit, Institute of Applied Health Research (S.M., N.I.), University of Birmingham, Birmingham, the Royal Devon and Exeter NHS Foundation Trust, Exeter (L.S.), the Department of Medicine, Imperial College London (C.D.P.), and Guys and St. Thomas' NHS Foundation Trust (A.L.C.), London, and the Department of Medicine, University of Cambridge (B.B., E.B., D.R.W.J.), and Addenbrooke's Hospital (D.R.W.J.), Cambridge - all in the United Kingdom; Spedali Civili di Brescia, Università di Brescia, Brescia, Italy (G.G.); the Division of Pulmonary and Critical Care Medicine, Mayo Clinic, Rochester, MN (U.S.); the Department of Nephrology, General University Hospital, Charles University, Prague, Czech Republic (V.T.); the Renal Service, Waitemata District Health Board, and the Department of Medicine, University of Auckland, Auckland, New Zealand (J.R.Z.); Jagiellonian University Medical College, Krakow, Poland (W.S.); and the Primary Systemic Vasculitides Clinic, Instituto Nacional de Enfermedades Respiratorias, Mexico City (L.F.F.-S.).""}, {'ForeName': 'Luis Felipe', 'Initials': 'LF', 'LastName': 'Flores-Suárez', 'Affiliation': ""From the Population Health Research Institute, McMaster University-Hamilton Health Sciences (M.W.), and the Departments of Medicine (M.W., N.K.) and Health Research Methods, Evidence, and Impact (M.W.), McMaster University, and St. Joseph's Healthcare (M.W., N.K., A.M.), Hamilton, ON, the Division of Nephrology and the Li Ka Shing Knowledge Institute, St. Michael's Hospital (R.W.), and the Department of Medicine (R.W.), the Vasculitis Clinic, Department of Rheumatology (C.P., S.C.), and Mount Sinai Hospital, Division of Rheumatology (C.P., S.C.), University of Toronto, Toronto, the Department of Medicine, University of Calgary, Calgary, AB (L.P.G.), the Department of Medicine, University of British Columbia, Vancouver (A.L.), and the Department of Medicine, University of Western Ontario, London (W.F.C.) - all in Canada; the Division of Rheumatology, Departments of Medicine and Biostatistics, Epidemiology, and Informatics, University of Pennsylvania, Philadelphia (P.A.M., C.A.M.); Royal Adelaide Hospital and the University of Adelaide, Adelaide (C.-A.P.), and the Australasian Kidney Trials Network, University of Queensland, Brisbane (C.M.H., D.R.) - all in Australia; Rigshospitalet University Hospital, Department of Nephrology, Copenhagen (W.M.S.); Assistance Publique-Hôpitaux de Paris, Hôpital Cochin, Université Paris Descartes, Paris (X.P., L.G.); the Faculty of Medicine, University of Miyazaki, Miyazaki (S.F.), and the Institute for Advancement of Clinical and Translational Science, Kyoto University Hospital, and the Clinical and Translational Research Center, University Hospital, Kyoto Prefectural University of Medicine, Kyoto (T.I.-I.) - all in Japan; Royal Berkshire Hospital, Reading (O.F.), the Institute of Clinical Sciences (L.H.) and the Birmingham Clinical Trials Unit, Institute of Applied Health Research (S.M., N.I.), University of Birmingham, Birmingham, the Royal Devon and Exeter NHS Foundation Trust, Exeter (L.S.), the Department of Medicine, Imperial College London (C.D.P.), and Guys and St. Thomas' NHS Foundation Trust (A.L.C.), London, and the Department of Medicine, University of Cambridge (B.B., E.B., D.R.W.J.), and Addenbrooke's Hospital (D.R.W.J.), Cambridge - all in the United Kingdom; Spedali Civili di Brescia, Università di Brescia, Brescia, Italy (G.G.); the Division of Pulmonary and Critical Care Medicine, Mayo Clinic, Rochester, MN (U.S.); the Department of Nephrology, General University Hospital, Charles University, Prague, Czech Republic (V.T.); the Renal Service, Waitemata District Health Board, and the Department of Medicine, University of Auckland, Auckland, New Zealand (J.R.Z.); Jagiellonian University Medical College, Krakow, Poland (W.S.); and the Primary Systemic Vasculitides Clinic, Instituto Nacional de Enfermedades Respiratorias, Mexico City (L.F.F.-S.).""}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Carette', 'Affiliation': ""From the Population Health Research Institute, McMaster University-Hamilton Health Sciences (M.W.), and the Departments of Medicine (M.W., N.K.) and Health Research Methods, Evidence, and Impact (M.W.), McMaster University, and St. Joseph's Healthcare (M.W., N.K., A.M.), Hamilton, ON, the Division of Nephrology and the Li Ka Shing Knowledge Institute, St. Michael's Hospital (R.W.), and the Department of Medicine (R.W.), the Vasculitis Clinic, Department of Rheumatology (C.P., S.C.), and Mount Sinai Hospital, Division of Rheumatology (C.P., S.C.), University of Toronto, Toronto, the Department of Medicine, University of Calgary, Calgary, AB (L.P.G.), the Department of Medicine, University of British Columbia, Vancouver (A.L.), and the Department of Medicine, University of Western Ontario, London (W.F.C.) - all in Canada; the Division of Rheumatology, Departments of Medicine and Biostatistics, Epidemiology, and Informatics, University of Pennsylvania, Philadelphia (P.A.M., C.A.M.); Royal Adelaide Hospital and the University of Adelaide, Adelaide (C.-A.P.), and the Australasian Kidney Trials Network, University of Queensland, Brisbane (C.M.H., D.R.) - all in Australia; Rigshospitalet University Hospital, Department of Nephrology, Copenhagen (W.M.S.); Assistance Publique-Hôpitaux de Paris, Hôpital Cochin, Université Paris Descartes, Paris (X.P., L.G.); the Faculty of Medicine, University of Miyazaki, Miyazaki (S.F.), and the Institute for Advancement of Clinical and Translational Science, Kyoto University Hospital, and the Clinical and Translational Research Center, University Hospital, Kyoto Prefectural University of Medicine, Kyoto (T.I.-I.) - all in Japan; Royal Berkshire Hospital, Reading (O.F.), the Institute of Clinical Sciences (L.H.) and the Birmingham Clinical Trials Unit, Institute of Applied Health Research (S.M., N.I.), University of Birmingham, Birmingham, the Royal Devon and Exeter NHS Foundation Trust, Exeter (L.S.), the Department of Medicine, Imperial College London (C.D.P.), and Guys and St. Thomas' NHS Foundation Trust (A.L.C.), London, and the Department of Medicine, University of Cambridge (B.B., E.B., D.R.W.J.), and Addenbrooke's Hospital (D.R.W.J.), Cambridge - all in the United Kingdom; Spedali Civili di Brescia, Università di Brescia, Brescia, Italy (G.G.); the Division of Pulmonary and Critical Care Medicine, Mayo Clinic, Rochester, MN (U.S.); the Department of Nephrology, General University Hospital, Charles University, Prague, Czech Republic (V.T.); the Renal Service, Waitemata District Health Board, and the Department of Medicine, University of Auckland, Auckland, New Zealand (J.R.Z.); Jagiellonian University Medical College, Krakow, Poland (W.S.); and the Primary Systemic Vasculitides Clinic, Instituto Nacional de Enfermedades Respiratorias, Mexico City (L.F.F.-S.).""}, {'ForeName': 'Loïc', 'Initials': 'L', 'LastName': 'Guillevin', 'Affiliation': ""From the Population Health Research Institute, McMaster University-Hamilton Health Sciences (M.W.), and the Departments of Medicine (M.W., N.K.) and Health Research Methods, Evidence, and Impact (M.W.), McMaster University, and St. Joseph's Healthcare (M.W., N.K., A.M.), Hamilton, ON, the Division of Nephrology and the Li Ka Shing Knowledge Institute, St. Michael's Hospital (R.W.), and the Department of Medicine (R.W.), the Vasculitis Clinic, Department of Rheumatology (C.P., S.C.), and Mount Sinai Hospital, Division of Rheumatology (C.P., S.C.), University of Toronto, Toronto, the Department of Medicine, University of Calgary, Calgary, AB (L.P.G.), the Department of Medicine, University of British Columbia, Vancouver (A.L.), and the Department of Medicine, University of Western Ontario, London (W.F.C.) - all in Canada; the Division of Rheumatology, Departments of Medicine and Biostatistics, Epidemiology, and Informatics, University of Pennsylvania, Philadelphia (P.A.M., C.A.M.); Royal Adelaide Hospital and the University of Adelaide, Adelaide (C.-A.P.), and the Australasian Kidney Trials Network, University of Queensland, Brisbane (C.M.H., D.R.) - all in Australia; Rigshospitalet University Hospital, Department of Nephrology, Copenhagen (W.M.S.); Assistance Publique-Hôpitaux de Paris, Hôpital Cochin, Université Paris Descartes, Paris (X.P., L.G.); the Faculty of Medicine, University of Miyazaki, Miyazaki (S.F.), and the Institute for Advancement of Clinical and Translational Science, Kyoto University Hospital, and the Clinical and Translational Research Center, University Hospital, Kyoto Prefectural University of Medicine, Kyoto (T.I.-I.) - all in Japan; Royal Berkshire Hospital, Reading (O.F.), the Institute of Clinical Sciences (L.H.) and the Birmingham Clinical Trials Unit, Institute of Applied Health Research (S.M., N.I.), University of Birmingham, Birmingham, the Royal Devon and Exeter NHS Foundation Trust, Exeter (L.S.), the Department of Medicine, Imperial College London (C.D.P.), and Guys and St. Thomas' NHS Foundation Trust (A.L.C.), London, and the Department of Medicine, University of Cambridge (B.B., E.B., D.R.W.J.), and Addenbrooke's Hospital (D.R.W.J.), Cambridge - all in the United Kingdom; Spedali Civili di Brescia, Università di Brescia, Brescia, Italy (G.G.); the Division of Pulmonary and Critical Care Medicine, Mayo Clinic, Rochester, MN (U.S.); the Department of Nephrology, General University Hospital, Charles University, Prague, Czech Republic (V.T.); the Renal Service, Waitemata District Health Board, and the Department of Medicine, University of Auckland, Auckland, New Zealand (J.R.Z.); Jagiellonian University Medical College, Krakow, Poland (W.S.); and the Primary Systemic Vasculitides Clinic, Instituto Nacional de Enfermedades Respiratorias, Mexico City (L.F.F.-S.).""}, {'ForeName': 'Charles D', 'Initials': 'CD', 'LastName': 'Pusey', 'Affiliation': ""From the Population Health Research Institute, McMaster University-Hamilton Health Sciences (M.W.), and the Departments of Medicine (M.W., N.K.) and Health Research Methods, Evidence, and Impact (M.W.), McMaster University, and St. Joseph's Healthcare (M.W., N.K., A.M.), Hamilton, ON, the Division of Nephrology and the Li Ka Shing Knowledge Institute, St. Michael's Hospital (R.W.), and the Department of Medicine (R.W.), the Vasculitis Clinic, Department of Rheumatology (C.P., S.C.), and Mount Sinai Hospital, Division of Rheumatology (C.P., S.C.), University of Toronto, Toronto, the Department of Medicine, University of Calgary, Calgary, AB (L.P.G.), the Department of Medicine, University of British Columbia, Vancouver (A.L.), and the Department of Medicine, University of Western Ontario, London (W.F.C.) - all in Canada; the Division of Rheumatology, Departments of Medicine and Biostatistics, Epidemiology, and Informatics, University of Pennsylvania, Philadelphia (P.A.M., C.A.M.); Royal Adelaide Hospital and the University of Adelaide, Adelaide (C.-A.P.), and the Australasian Kidney Trials Network, University of Queensland, Brisbane (C.M.H., D.R.) - all in Australia; Rigshospitalet University Hospital, Department of Nephrology, Copenhagen (W.M.S.); Assistance Publique-Hôpitaux de Paris, Hôpital Cochin, Université Paris Descartes, Paris (X.P., L.G.); the Faculty of Medicine, University of Miyazaki, Miyazaki (S.F.), and the Institute for Advancement of Clinical and Translational Science, Kyoto University Hospital, and the Clinical and Translational Research Center, University Hospital, Kyoto Prefectural University of Medicine, Kyoto (T.I.-I.) - all in Japan; Royal Berkshire Hospital, Reading (O.F.), the Institute of Clinical Sciences (L.H.) and the Birmingham Clinical Trials Unit, Institute of Applied Health Research (S.M., N.I.), University of Birmingham, Birmingham, the Royal Devon and Exeter NHS Foundation Trust, Exeter (L.S.), the Department of Medicine, Imperial College London (C.D.P.), and Guys and St. Thomas' NHS Foundation Trust (A.L.C.), London, and the Department of Medicine, University of Cambridge (B.B., E.B., D.R.W.J.), and Addenbrooke's Hospital (D.R.W.J.), Cambridge - all in the United Kingdom; Spedali Civili di Brescia, Università di Brescia, Brescia, Italy (G.G.); the Division of Pulmonary and Critical Care Medicine, Mayo Clinic, Rochester, MN (U.S.); the Department of Nephrology, General University Hospital, Charles University, Prague, Czech Republic (V.T.); the Renal Service, Waitemata District Health Board, and the Department of Medicine, University of Auckland, Auckland, New Zealand (J.R.Z.); Jagiellonian University Medical College, Krakow, Poland (W.S.); and the Primary Systemic Vasculitides Clinic, Instituto Nacional de Enfermedades Respiratorias, Mexico City (L.F.F.-S.).""}, {'ForeName': 'Alina L', 'Initials': 'AL', 'LastName': 'Casian', 'Affiliation': ""From the Population Health Research Institute, McMaster University-Hamilton Health Sciences (M.W.), and the Departments of Medicine (M.W., N.K.) and Health Research Methods, Evidence, and Impact (M.W.), McMaster University, and St. Joseph's Healthcare (M.W., N.K., A.M.), Hamilton, ON, the Division of Nephrology and the Li Ka Shing Knowledge Institute, St. Michael's Hospital (R.W.), and the Department of Medicine (R.W.), the Vasculitis Clinic, Department of Rheumatology (C.P., S.C.), and Mount Sinai Hospital, Division of Rheumatology (C.P., S.C.), University of Toronto, Toronto, the Department of Medicine, University of Calgary, Calgary, AB (L.P.G.), the Department of Medicine, University of British Columbia, Vancouver (A.L.), and the Department of Medicine, University of Western Ontario, London (W.F.C.) - all in Canada; the Division of Rheumatology, Departments of Medicine and Biostatistics, Epidemiology, and Informatics, University of Pennsylvania, Philadelphia (P.A.M., C.A.M.); Royal Adelaide Hospital and the University of Adelaide, Adelaide (C.-A.P.), and the Australasian Kidney Trials Network, University of Queensland, Brisbane (C.M.H., D.R.) - all in Australia; Rigshospitalet University Hospital, Department of Nephrology, Copenhagen (W.M.S.); Assistance Publique-Hôpitaux de Paris, Hôpital Cochin, Université Paris Descartes, Paris (X.P., L.G.); the Faculty of Medicine, University of Miyazaki, Miyazaki (S.F.), and the Institute for Advancement of Clinical and Translational Science, Kyoto University Hospital, and the Clinical and Translational Research Center, University Hospital, Kyoto Prefectural University of Medicine, Kyoto (T.I.-I.) - all in Japan; Royal Berkshire Hospital, Reading (O.F.), the Institute of Clinical Sciences (L.H.) and the Birmingham Clinical Trials Unit, Institute of Applied Health Research (S.M., N.I.), University of Birmingham, Birmingham, the Royal Devon and Exeter NHS Foundation Trust, Exeter (L.S.), the Department of Medicine, Imperial College London (C.D.P.), and Guys and St. Thomas' NHS Foundation Trust (A.L.C.), London, and the Department of Medicine, University of Cambridge (B.B., E.B., D.R.W.J.), and Addenbrooke's Hospital (D.R.W.J.), Cambridge - all in the United Kingdom; Spedali Civili di Brescia, Università di Brescia, Brescia, Italy (G.G.); the Division of Pulmonary and Critical Care Medicine, Mayo Clinic, Rochester, MN (U.S.); the Department of Nephrology, General University Hospital, Charles University, Prague, Czech Republic (V.T.); the Renal Service, Waitemata District Health Board, and the Department of Medicine, University of Auckland, Auckland, New Zealand (J.R.Z.); Jagiellonian University Medical College, Krakow, Poland (W.S.); and the Primary Systemic Vasculitides Clinic, Instituto Nacional de Enfermedades Respiratorias, Mexico City (L.F.F.-S.).""}, {'ForeName': 'Biljana', 'Initials': 'B', 'LastName': 'Brezina', 'Affiliation': ""From the Population Health Research Institute, McMaster University-Hamilton Health Sciences (M.W.), and the Departments of Medicine (M.W., N.K.) and Health Research Methods, Evidence, and Impact (M.W.), McMaster University, and St. Joseph's Healthcare (M.W., N.K., A.M.), Hamilton, ON, the Division of Nephrology and the Li Ka Shing Knowledge Institute, St. Michael's Hospital (R.W.), and the Department of Medicine (R.W.), the Vasculitis Clinic, Department of Rheumatology (C.P., S.C.), and Mount Sinai Hospital, Division of Rheumatology (C.P., S.C.), University of Toronto, Toronto, the Department of Medicine, University of Calgary, Calgary, AB (L.P.G.), the Department of Medicine, University of British Columbia, Vancouver (A.L.), and the Department of Medicine, University of Western Ontario, London (W.F.C.) - all in Canada; the Division of Rheumatology, Departments of Medicine and Biostatistics, Epidemiology, and Informatics, University of Pennsylvania, Philadelphia (P.A.M., C.A.M.); Royal Adelaide Hospital and the University of Adelaide, Adelaide (C.-A.P.), and the Australasian Kidney Trials Network, University of Queensland, Brisbane (C.M.H., D.R.) - all in Australia; Rigshospitalet University Hospital, Department of Nephrology, Copenhagen (W.M.S.); Assistance Publique-Hôpitaux de Paris, Hôpital Cochin, Université Paris Descartes, Paris (X.P., L.G.); the Faculty of Medicine, University of Miyazaki, Miyazaki (S.F.), and the Institute for Advancement of Clinical and Translational Science, Kyoto University Hospital, and the Clinical and Translational Research Center, University Hospital, Kyoto Prefectural University of Medicine, Kyoto (T.I.-I.) - all in Japan; Royal Berkshire Hospital, Reading (O.F.), the Institute of Clinical Sciences (L.H.) and the Birmingham Clinical Trials Unit, Institute of Applied Health Research (S.M., N.I.), University of Birmingham, Birmingham, the Royal Devon and Exeter NHS Foundation Trust, Exeter (L.S.), the Department of Medicine, Imperial College London (C.D.P.), and Guys and St. Thomas' NHS Foundation Trust (A.L.C.), London, and the Department of Medicine, University of Cambridge (B.B., E.B., D.R.W.J.), and Addenbrooke's Hospital (D.R.W.J.), Cambridge - all in the United Kingdom; Spedali Civili di Brescia, Università di Brescia, Brescia, Italy (G.G.); the Division of Pulmonary and Critical Care Medicine, Mayo Clinic, Rochester, MN (U.S.); the Department of Nephrology, General University Hospital, Charles University, Prague, Czech Republic (V.T.); the Renal Service, Waitemata District Health Board, and the Department of Medicine, University of Auckland, Auckland, New Zealand (J.R.Z.); Jagiellonian University Medical College, Krakow, Poland (W.S.); and the Primary Systemic Vasculitides Clinic, Instituto Nacional de Enfermedades Respiratorias, Mexico City (L.F.F.-S.).""}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Mazzetti', 'Affiliation': ""From the Population Health Research Institute, McMaster University-Hamilton Health Sciences (M.W.), and the Departments of Medicine (M.W., N.K.) and Health Research Methods, Evidence, and Impact (M.W.), McMaster University, and St. Joseph's Healthcare (M.W., N.K., A.M.), Hamilton, ON, the Division of Nephrology and the Li Ka Shing Knowledge Institute, St. Michael's Hospital (R.W.), and the Department of Medicine (R.W.), the Vasculitis Clinic, Department of Rheumatology (C.P., S.C.), and Mount Sinai Hospital, Division of Rheumatology (C.P., S.C.), University of Toronto, Toronto, the Department of Medicine, University of Calgary, Calgary, AB (L.P.G.), the Department of Medicine, University of British Columbia, Vancouver (A.L.), and the Department of Medicine, University of Western Ontario, London (W.F.C.) - all in Canada; the Division of Rheumatology, Departments of Medicine and Biostatistics, Epidemiology, and Informatics, University of Pennsylvania, Philadelphia (P.A.M., C.A.M.); Royal Adelaide Hospital and the University of Adelaide, Adelaide (C.-A.P.), and the Australasian Kidney Trials Network, University of Queensland, Brisbane (C.M.H., D.R.) - all in Australia; Rigshospitalet University Hospital, Department of Nephrology, Copenhagen (W.M.S.); Assistance Publique-Hôpitaux de Paris, Hôpital Cochin, Université Paris Descartes, Paris (X.P., L.G.); the Faculty of Medicine, University of Miyazaki, Miyazaki (S.F.), and the Institute for Advancement of Clinical and Translational Science, Kyoto University Hospital, and the Clinical and Translational Research Center, University Hospital, Kyoto Prefectural University of Medicine, Kyoto (T.I.-I.) - all in Japan; Royal Berkshire Hospital, Reading (O.F.), the Institute of Clinical Sciences (L.H.) and the Birmingham Clinical Trials Unit, Institute of Applied Health Research (S.M., N.I.), University of Birmingham, Birmingham, the Royal Devon and Exeter NHS Foundation Trust, Exeter (L.S.), the Department of Medicine, Imperial College London (C.D.P.), and Guys and St. Thomas' NHS Foundation Trust (A.L.C.), London, and the Department of Medicine, University of Cambridge (B.B., E.B., D.R.W.J.), and Addenbrooke's Hospital (D.R.W.J.), Cambridge - all in the United Kingdom; Spedali Civili di Brescia, Università di Brescia, Brescia, Italy (G.G.); the Division of Pulmonary and Critical Care Medicine, Mayo Clinic, Rochester, MN (U.S.); the Department of Nephrology, General University Hospital, Charles University, Prague, Czech Republic (V.T.); the Renal Service, Waitemata District Health Board, and the Department of Medicine, University of Auckland, Auckland, New Zealand (J.R.Z.); Jagiellonian University Medical College, Krakow, Poland (W.S.); and the Primary Systemic Vasculitides Clinic, Instituto Nacional de Enfermedades Respiratorias, Mexico City (L.F.F.-S.).""}, {'ForeName': 'Carol A', 'Initials': 'CA', 'LastName': 'McAlear', 'Affiliation': ""From the Population Health Research Institute, McMaster University-Hamilton Health Sciences (M.W.), and the Departments of Medicine (M.W., N.K.) and Health Research Methods, Evidence, and Impact (M.W.), McMaster University, and St. Joseph's Healthcare (M.W., N.K., A.M.), Hamilton, ON, the Division of Nephrology and the Li Ka Shing Knowledge Institute, St. Michael's Hospital (R.W.), and the Department of Medicine (R.W.), the Vasculitis Clinic, Department of Rheumatology (C.P., S.C.), and Mount Sinai Hospital, Division of Rheumatology (C.P., S.C.), University of Toronto, Toronto, the Department of Medicine, University of Calgary, Calgary, AB (L.P.G.), the Department of Medicine, University of British Columbia, Vancouver (A.L.), and the Department of Medicine, University of Western Ontario, London (W.F.C.) - all in Canada; the Division of Rheumatology, Departments of Medicine and Biostatistics, Epidemiology, and Informatics, University of Pennsylvania, Philadelphia (P.A.M., C.A.M.); Royal Adelaide Hospital and the University of Adelaide, Adelaide (C.-A.P.), and the Australasian Kidney Trials Network, University of Queensland, Brisbane (C.M.H., D.R.) - all in Australia; Rigshospitalet University Hospital, Department of Nephrology, Copenhagen (W.M.S.); Assistance Publique-Hôpitaux de Paris, Hôpital Cochin, Université Paris Descartes, Paris (X.P., L.G.); the Faculty of Medicine, University of Miyazaki, Miyazaki (S.F.), and the Institute for Advancement of Clinical and Translational Science, Kyoto University Hospital, and the Clinical and Translational Research Center, University Hospital, Kyoto Prefectural University of Medicine, Kyoto (T.I.-I.) - all in Japan; Royal Berkshire Hospital, Reading (O.F.), the Institute of Clinical Sciences (L.H.) and the Birmingham Clinical Trials Unit, Institute of Applied Health Research (S.M., N.I.), University of Birmingham, Birmingham, the Royal Devon and Exeter NHS Foundation Trust, Exeter (L.S.), the Department of Medicine, Imperial College London (C.D.P.), and Guys and St. Thomas' NHS Foundation Trust (A.L.C.), London, and the Department of Medicine, University of Cambridge (B.B., E.B., D.R.W.J.), and Addenbrooke's Hospital (D.R.W.J.), Cambridge - all in the United Kingdom; Spedali Civili di Brescia, Università di Brescia, Brescia, Italy (G.G.); the Division of Pulmonary and Critical Care Medicine, Mayo Clinic, Rochester, MN (U.S.); the Department of Nephrology, General University Hospital, Charles University, Prague, Czech Republic (V.T.); the Renal Service, Waitemata District Health Board, and the Department of Medicine, University of Auckland, Auckland, New Zealand (J.R.Z.); Jagiellonian University Medical College, Krakow, Poland (W.S.); and the Primary Systemic Vasculitides Clinic, Instituto Nacional de Enfermedades Respiratorias, Mexico City (L.F.F.-S.).""}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Broadhurst', 'Affiliation': ""From the Population Health Research Institute, McMaster University-Hamilton Health Sciences (M.W.), and the Departments of Medicine (M.W., N.K.) and Health Research Methods, Evidence, and Impact (M.W.), McMaster University, and St. Joseph's Healthcare (M.W., N.K., A.M.), Hamilton, ON, the Division of Nephrology and the Li Ka Shing Knowledge Institute, St. Michael's Hospital (R.W.), and the Department of Medicine (R.W.), the Vasculitis Clinic, Department of Rheumatology (C.P., S.C.), and Mount Sinai Hospital, Division of Rheumatology (C.P., S.C.), University of Toronto, Toronto, the Department of Medicine, University of Calgary, Calgary, AB (L.P.G.), the Department of Medicine, University of British Columbia, Vancouver (A.L.), and the Department of Medicine, University of Western Ontario, London (W.F.C.) - all in Canada; the Division of Rheumatology, Departments of Medicine and Biostatistics, Epidemiology, and Informatics, University of Pennsylvania, Philadelphia (P.A.M., C.A.M.); Royal Adelaide Hospital and the University of Adelaide, Adelaide (C.-A.P.), and the Australasian Kidney Trials Network, University of Queensland, Brisbane (C.M.H., D.R.) - all in Australia; Rigshospitalet University Hospital, Department of Nephrology, Copenhagen (W.M.S.); Assistance Publique-Hôpitaux de Paris, Hôpital Cochin, Université Paris Descartes, Paris (X.P., L.G.); the Faculty of Medicine, University of Miyazaki, Miyazaki (S.F.), and the Institute for Advancement of Clinical and Translational Science, Kyoto University Hospital, and the Clinical and Translational Research Center, University Hospital, Kyoto Prefectural University of Medicine, Kyoto (T.I.-I.) - all in Japan; Royal Berkshire Hospital, Reading (O.F.), the Institute of Clinical Sciences (L.H.) and the Birmingham Clinical Trials Unit, Institute of Applied Health Research (S.M., N.I.), University of Birmingham, Birmingham, the Royal Devon and Exeter NHS Foundation Trust, Exeter (L.S.), the Department of Medicine, Imperial College London (C.D.P.), and Guys and St. Thomas' NHS Foundation Trust (A.L.C.), London, and the Department of Medicine, University of Cambridge (B.B., E.B., D.R.W.J.), and Addenbrooke's Hospital (D.R.W.J.), Cambridge - all in the United Kingdom; Spedali Civili di Brescia, Università di Brescia, Brescia, Italy (G.G.); the Division of Pulmonary and Critical Care Medicine, Mayo Clinic, Rochester, MN (U.S.); the Department of Nephrology, General University Hospital, Charles University, Prague, Czech Republic (V.T.); the Renal Service, Waitemata District Health Board, and the Department of Medicine, University of Auckland, Auckland, New Zealand (J.R.Z.); Jagiellonian University Medical College, Krakow, Poland (W.S.); and the Primary Systemic Vasculitides Clinic, Instituto Nacional de Enfermedades Respiratorias, Mexico City (L.F.F.-S.).""}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Reidlinger', 'Affiliation': ""From the Population Health Research Institute, McMaster University-Hamilton Health Sciences (M.W.), and the Departments of Medicine (M.W., N.K.) and Health Research Methods, Evidence, and Impact (M.W.), McMaster University, and St. Joseph's Healthcare (M.W., N.K., A.M.), Hamilton, ON, the Division of Nephrology and the Li Ka Shing Knowledge Institute, St. Michael's Hospital (R.W.), and the Department of Medicine (R.W.), the Vasculitis Clinic, Department of Rheumatology (C.P., S.C.), and Mount Sinai Hospital, Division of Rheumatology (C.P., S.C.), University of Toronto, Toronto, the Department of Medicine, University of Calgary, Calgary, AB (L.P.G.), the Department of Medicine, University of British Columbia, Vancouver (A.L.), and the Department of Medicine, University of Western Ontario, London (W.F.C.) - all in Canada; the Division of Rheumatology, Departments of Medicine and Biostatistics, Epidemiology, and Informatics, University of Pennsylvania, Philadelphia (P.A.M., C.A.M.); Royal Adelaide Hospital and the University of Adelaide, Adelaide (C.-A.P.), and the Australasian Kidney Trials Network, University of Queensland, Brisbane (C.M.H., D.R.) - all in Australia; Rigshospitalet University Hospital, Department of Nephrology, Copenhagen (W.M.S.); Assistance Publique-Hôpitaux de Paris, Hôpital Cochin, Université Paris Descartes, Paris (X.P., L.G.); the Faculty of Medicine, University of Miyazaki, Miyazaki (S.F.), and the Institute for Advancement of Clinical and Translational Science, Kyoto University Hospital, and the Clinical and Translational Research Center, University Hospital, Kyoto Prefectural University of Medicine, Kyoto (T.I.-I.) - all in Japan; Royal Berkshire Hospital, Reading (O.F.), the Institute of Clinical Sciences (L.H.) and the Birmingham Clinical Trials Unit, Institute of Applied Health Research (S.M., N.I.), University of Birmingham, Birmingham, the Royal Devon and Exeter NHS Foundation Trust, Exeter (L.S.), the Department of Medicine, Imperial College London (C.D.P.), and Guys and St. Thomas' NHS Foundation Trust (A.L.C.), London, and the Department of Medicine, University of Cambridge (B.B., E.B., D.R.W.J.), and Addenbrooke's Hospital (D.R.W.J.), Cambridge - all in the United Kingdom; Spedali Civili di Brescia, Università di Brescia, Brescia, Italy (G.G.); the Division of Pulmonary and Critical Care Medicine, Mayo Clinic, Rochester, MN (U.S.); the Department of Nephrology, General University Hospital, Charles University, Prague, Czech Republic (V.T.); the Renal Service, Waitemata District Health Board, and the Department of Medicine, University of Auckland, Auckland, New Zealand (J.R.Z.); Jagiellonian University Medical College, Krakow, Poland (W.S.); and the Primary Systemic Vasculitides Clinic, Instituto Nacional de Enfermedades Respiratorias, Mexico City (L.F.F.-S.).""}, {'ForeName': 'Samir', 'Initials': 'S', 'LastName': 'Mehta', 'Affiliation': ""From the Population Health Research Institute, McMaster University-Hamilton Health Sciences (M.W.), and the Departments of Medicine (M.W., N.K.) and Health Research Methods, Evidence, and Impact (M.W.), McMaster University, and St. Joseph's Healthcare (M.W., N.K., A.M.), Hamilton, ON, the Division of Nephrology and the Li Ka Shing Knowledge Institute, St. Michael's Hospital (R.W.), and the Department of Medicine (R.W.), the Vasculitis Clinic, Department of Rheumatology (C.P., S.C.), and Mount Sinai Hospital, Division of Rheumatology (C.P., S.C.), University of Toronto, Toronto, the Department of Medicine, University of Calgary, Calgary, AB (L.P.G.), the Department of Medicine, University of British Columbia, Vancouver (A.L.), and the Department of Medicine, University of Western Ontario, London (W.F.C.) - all in Canada; the Division of Rheumatology, Departments of Medicine and Biostatistics, Epidemiology, and Informatics, University of Pennsylvania, Philadelphia (P.A.M., C.A.M.); Royal Adelaide Hospital and the University of Adelaide, Adelaide (C.-A.P.), and the Australasian Kidney Trials Network, University of Queensland, Brisbane (C.M.H., D.R.) - all in Australia; Rigshospitalet University Hospital, Department of Nephrology, Copenhagen (W.M.S.); Assistance Publique-Hôpitaux de Paris, Hôpital Cochin, Université Paris Descartes, Paris (X.P., L.G.); the Faculty of Medicine, University of Miyazaki, Miyazaki (S.F.), and the Institute for Advancement of Clinical and Translational Science, Kyoto University Hospital, and the Clinical and Translational Research Center, University Hospital, Kyoto Prefectural University of Medicine, Kyoto (T.I.-I.) - all in Japan; Royal Berkshire Hospital, Reading (O.F.), the Institute of Clinical Sciences (L.H.) and the Birmingham Clinical Trials Unit, Institute of Applied Health Research (S.M., N.I.), University of Birmingham, Birmingham, the Royal Devon and Exeter NHS Foundation Trust, Exeter (L.S.), the Department of Medicine, Imperial College London (C.D.P.), and Guys and St. Thomas' NHS Foundation Trust (A.L.C.), London, and the Department of Medicine, University of Cambridge (B.B., E.B., D.R.W.J.), and Addenbrooke's Hospital (D.R.W.J.), Cambridge - all in the United Kingdom; Spedali Civili di Brescia, Università di Brescia, Brescia, Italy (G.G.); the Division of Pulmonary and Critical Care Medicine, Mayo Clinic, Rochester, MN (U.S.); the Department of Nephrology, General University Hospital, Charles University, Prague, Czech Republic (V.T.); the Renal Service, Waitemata District Health Board, and the Department of Medicine, University of Auckland, Auckland, New Zealand (J.R.Z.); Jagiellonian University Medical College, Krakow, Poland (W.S.); and the Primary Systemic Vasculitides Clinic, Instituto Nacional de Enfermedades Respiratorias, Mexico City (L.F.F.-S.).""}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Ives', 'Affiliation': ""From the Population Health Research Institute, McMaster University-Hamilton Health Sciences (M.W.), and the Departments of Medicine (M.W., N.K.) and Health Research Methods, Evidence, and Impact (M.W.), McMaster University, and St. Joseph's Healthcare (M.W., N.K., A.M.), Hamilton, ON, the Division of Nephrology and the Li Ka Shing Knowledge Institute, St. Michael's Hospital (R.W.), and the Department of Medicine (R.W.), the Vasculitis Clinic, Department of Rheumatology (C.P., S.C.), and Mount Sinai Hospital, Division of Rheumatology (C.P., S.C.), University of Toronto, Toronto, the Department of Medicine, University of Calgary, Calgary, AB (L.P.G.), the Department of Medicine, University of British Columbia, Vancouver (A.L.), and the Department of Medicine, University of Western Ontario, London (W.F.C.) - all in Canada; the Division of Rheumatology, Departments of Medicine and Biostatistics, Epidemiology, and Informatics, University of Pennsylvania, Philadelphia (P.A.M., C.A.M.); Royal Adelaide Hospital and the University of Adelaide, Adelaide (C.-A.P.), and the Australasian Kidney Trials Network, University of Queensland, Brisbane (C.M.H., D.R.) - all in Australia; Rigshospitalet University Hospital, Department of Nephrology, Copenhagen (W.M.S.); Assistance Publique-Hôpitaux de Paris, Hôpital Cochin, Université Paris Descartes, Paris (X.P., L.G.); the Faculty of Medicine, University of Miyazaki, Miyazaki (S.F.), and the Institute for Advancement of Clinical and Translational Science, Kyoto University Hospital, and the Clinical and Translational Research Center, University Hospital, Kyoto Prefectural University of Medicine, Kyoto (T.I.-I.) - all in Japan; Royal Berkshire Hospital, Reading (O.F.), the Institute of Clinical Sciences (L.H.) and the Birmingham Clinical Trials Unit, Institute of Applied Health Research (S.M., N.I.), University of Birmingham, Birmingham, the Royal Devon and Exeter NHS Foundation Trust, Exeter (L.S.), the Department of Medicine, Imperial College London (C.D.P.), and Guys and St. Thomas' NHS Foundation Trust (A.L.C.), London, and the Department of Medicine, University of Cambridge (B.B., E.B., D.R.W.J.), and Addenbrooke's Hospital (D.R.W.J.), Cambridge - all in the United Kingdom; Spedali Civili di Brescia, Università di Brescia, Brescia, Italy (G.G.); the Division of Pulmonary and Critical Care Medicine, Mayo Clinic, Rochester, MN (U.S.); the Department of Nephrology, General University Hospital, Charles University, Prague, Czech Republic (V.T.); the Renal Service, Waitemata District Health Board, and the Department of Medicine, University of Auckland, Auckland, New Zealand (J.R.Z.); Jagiellonian University Medical College, Krakow, Poland (W.S.); and the Primary Systemic Vasculitides Clinic, Instituto Nacional de Enfermedades Respiratorias, Mexico City (L.F.F.-S.).""}, {'ForeName': 'David R W', 'Initials': 'DRW', 'LastName': 'Jayne', 'Affiliation': ""From the Population Health Research Institute, McMaster University-Hamilton Health Sciences (M.W.), and the Departments of Medicine (M.W., N.K.) and Health Research Methods, Evidence, and Impact (M.W.), McMaster University, and St. Joseph's Healthcare (M.W., N.K., A.M.), Hamilton, ON, the Division of Nephrology and the Li Ka Shing Knowledge Institute, St. Michael's Hospital (R.W.), and the Department of Medicine (R.W.), the Vasculitis Clinic, Department of Rheumatology (C.P., S.C.), and Mount Sinai Hospital, Division of Rheumatology (C.P., S.C.), University of Toronto, Toronto, the Department of Medicine, University of Calgary, Calgary, AB (L.P.G.), the Department of Medicine, University of British Columbia, Vancouver (A.L.), and the Department of Medicine, University of Western Ontario, London (W.F.C.) - all in Canada; the Division of Rheumatology, Departments of Medicine and Biostatistics, Epidemiology, and Informatics, University of Pennsylvania, Philadelphia (P.A.M., C.A.M.); Royal Adelaide Hospital and the University of Adelaide, Adelaide (C.-A.P.), and the Australasian Kidney Trials Network, University of Queensland, Brisbane (C.M.H., D.R.) - all in Australia; Rigshospitalet University Hospital, Department of Nephrology, Copenhagen (W.M.S.); Assistance Publique-Hôpitaux de Paris, Hôpital Cochin, Université Paris Descartes, Paris (X.P., L.G.); the Faculty of Medicine, University of Miyazaki, Miyazaki (S.F.), and the Institute for Advancement of Clinical and Translational Science, Kyoto University Hospital, and the Clinical and Translational Research Center, University Hospital, Kyoto Prefectural University of Medicine, Kyoto (T.I.-I.) - all in Japan; Royal Berkshire Hospital, Reading (O.F.), the Institute of Clinical Sciences (L.H.) and the Birmingham Clinical Trials Unit, Institute of Applied Health Research (S.M., N.I.), University of Birmingham, Birmingham, the Royal Devon and Exeter NHS Foundation Trust, Exeter (L.S.), the Department of Medicine, Imperial College London (C.D.P.), and Guys and St. Thomas' NHS Foundation Trust (A.L.C.), London, and the Department of Medicine, University of Cambridge (B.B., E.B., D.R.W.J.), and Addenbrooke's Hospital (D.R.W.J.), Cambridge - all in the United Kingdom; Spedali Civili di Brescia, Università di Brescia, Brescia, Italy (G.G.); the Division of Pulmonary and Critical Care Medicine, Mayo Clinic, Rochester, MN (U.S.); the Department of Nephrology, General University Hospital, Charles University, Prague, Czech Republic (V.T.); the Renal Service, Waitemata District Health Board, and the Department of Medicine, University of Auckland, Auckland, New Zealand (J.R.Z.); Jagiellonian University Medical College, Krakow, Poland (W.S.); and the Primary Systemic Vasculitides Clinic, Instituto Nacional de Enfermedades Respiratorias, Mexico City (L.F.F.-S.).""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa1803537'] 314,31629656,"Short-term androgen deprivation therapy combined with radiotherapy as salvage treatment after radical prostatectomy for prostate cancer (GETUG-AFU 16): a 112-month follow-up of a phase 3, randomised trial.","BACKGROUND Radiotherapy is the standard salvage treatment after radical prostatectomy. To date, the role of androgen deprivation therapy has not been formally shown. In this follow-up study, we aimed to update the results of the GETUG-AFU 16 trial, which assessed the efficacy of radiotherapy plus androgen suppression versus radiotherapy alone. METHODS GETUG-AFU 16 was an open-label, multicentre, phase 3, randomised, controlled trial that enrolled men (aged ≥18 years) with Eastern Cooperative Oncology Group performance status of 0 or 1, with histologically confirmed adenocarcinoma of the prostate (but no previous androgen suppression or pelvic radiotherapy), stage pT2, T3, or T4a (bladder neck involvement only) and pN0 or pNx according to the tumour, node, metastasis (TNM) staging system, whose prostate-specific antigen (PSA) concentration increased from 0·1 ng/mL to between 0·2 ng/mL and 2·0 ng/mL after radical prostatectomy, without evidence of clinical disease. Patients were assigned through central randomisation (1:1) to short-term androgen suppression (subcutaneous injection of 10·8 mg goserelin on the first day of irradiation and 3 months later) plus radiotherapy (3D conformal radiotherapy or intensity modulated radiotherapy of 66 Gy in 33 fractions, 5 days a week for 7 weeks) or radiotherapy alone. Randomisation was stratified using a permuted block method (block sizes of two and four) according to investigational site, radiotherapy modality, and prognosis. The primary endpoint was progression-free survival in the intention-to-treat population. This post-hoc one-shot data collection done 4 years after last data cutoff included patients who were alive at the time of the primary analysis and updated long-term patient status by including dates for first local progression, metastatic disease diagnosis, or death (if any of these had occurred) or the date of the last tumour evaluation or last PSA measurement. Survival at 120 months was reported. Late serious adverse effects were assessed. This trial is registered on ClinicalTrials.gov, NCT00423475. FINDINGS Between Oct 19, 2006, and March 30, 2010, 743 patients were randomly assigned, 374 to radiotherapy alone and 369 to radiotherapy plus goserelin. At the time of data cutoff (March 12, 2019), the median follow-up was 112 months (IQR 102-123). The 120-month progression-free survival was 64% (95% CI 58-69) for patients treated with radiotherapy plus goserelin and 49% (43-54) for patients treated with radiotherapy alone (hazard ratio 0·54, 0·43-0·68; stratified log-rank test p<0·0001). Two cases of secondary cancer occurred since the primary analysis, but were not considered to be treatment related. No treatment-related deaths occurred. INTERPRETATION The 120-month progression-free survival confirmed the results from the primary analysis. Salvage radiotherapy combined with short-term androgen suppression significantly reduced risk of biochemical or clinical progression and death compared with salvage radiotherapy alone. The results of the GETUG-AFU 16 trial confirm the efficacy of androgen suppression plus radiotherapy as salvage treatment in patients with increasing PSA concentration after radical prostatectomy for prostate cancer. FUNDING The French Health ministry, AstraZeneca, la Ligue Contre le Cancer, and La Ligue de Haute-Savoie.",2019,Salvage radiotherapy combined with short-term androgen suppression significantly reduced risk of biochemical or clinical progression and death compared with salvage radiotherapy alone.,"['743 patients were randomly assigned, 374 to', 'enrolled men (aged ≥18 years) with Eastern Cooperative Oncology Group performance status of 0 or 1, with histologically confirmed adenocarcinoma of the prostate (but no previous androgen suppression or pelvic radiotherapy), stage pT2, T3, or T4a (bladder neck involvement only) and pN0 or pNx according to the tumour, node, metastasis (TNM) staging system, whose prostate-specific antigen (PSA) concentration increased from 0·1', 'Between Oct 19, 2006, and March 30, 2010', 'patients with increasing PSA concentration after radical prostatectomy for prostate cancer', 'patients who were alive at the time of the primary analysis and updated long-term patient status by including dates for first local progression, metastatic disease diagnosis, or death (if any of these had occurred) or the date of the last tumour evaluation or last PSA measurement']","['radiotherapy alone and 369 to radiotherapy plus goserelin', 'radiotherapy plus goserelin', 'Salvage radiotherapy combined with short-term androgen suppression', 'Short-term androgen deprivation therapy combined with radiotherapy', 'radiotherapy alone', 'Radiotherapy', 'salvage radiotherapy', 'radiotherapy plus androgen suppression versus radiotherapy alone', 'radiotherapy (3D conformal radiotherapy or intensity modulated radiotherapy', 'short-term androgen suppression (subcutaneous injection of 10·8 mg goserelin', 'androgen deprivation therapy', 'androgen suppression plus radiotherapy', 'radiotherapy']","['120-month progression-free survival', 'progression-free survival', 'risk of biochemical or clinical progression and death', 'Late serious adverse effects', 'Survival']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1520224', 'cui_str': 'Eastern Cooperative Oncology Group performance status'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0001418', 'cui_str': 'Adenoma, Malignant'}, {'cui': 'C0033572', 'cui_str': 'Prostate'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0002844', 'cui_str': 'Androgenic Compounds'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression (disorder)'}, {'cui': 'C0030797', 'cui_str': 'Pelvic Region'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C4042485', 'cui_str': 'Pt(acac)2'}, {'cui': 'C0227716', 'cui_str': 'Structure of neck of urinary bladder'}, {'cui': 'C0205428', 'cui_str': 'Involvements (qualifier value)'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0138741', 'cui_str': 'gamma-Seminoprotein'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0201544', 'cui_str': 'Prostate specific antigen measurement (procedure)'}, {'cui': 'C0194810', 'cui_str': 'Radical prostatectomy (procedure)'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C2584946', 'cui_str': 'Alive'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0449437', 'cui_str': 'Patient status (attribute)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0011008', 'cui_str': 'Dates'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C2939420', 'cui_str': 'Metastatic disease'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]","[{'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0120107', 'cui_str': 'Goserelin'}, {'cui': 'C0442967', 'cui_str': 'Salvage procedure (qualifier value)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0002844', 'cui_str': 'Androgenic Compounds'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression (disorder)'}, {'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy (procedure)'}, {'cui': 'C0600521', 'cui_str': 'Three-Dimensional Conformal Radiotherapy'}, {'cui': 'C1512814', 'cui_str': 'Radiotherapy, Intensity-Modulated'}, {'cui': 'C0021499', 'cui_str': 'Subcutaneous Injections'}]","[{'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0205474', 'cui_str': 'Biochemical (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",743.0,0.219457,Salvage radiotherapy combined with short-term androgen suppression significantly reduced risk of biochemical or clinical progression and death compared with salvage radiotherapy alone.,"[{'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Carrie', 'Affiliation': 'Radiotherapy Department, Léon Bérard Center, Lyon, France; CNRS UMR 5220, INSERM U1044, INSA, University of Lyon, Lyon, France. Electronic address: christian.carrie@lyon.unicancer.fr.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Magné', 'Affiliation': 'Cellular and Molecular Radiobiology, Lucien Neuwirth Cancer Institute, and Institute of Nuclear Physics of Lyon, Lyon-Sud Faculty of Medicine, Lyon, France.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Burban-Provost', 'Affiliation': ""private hospital of Cotes D'armor, Plerin, France.""}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Sargos', 'Affiliation': 'Radiotherapy Department, Bergonié Institute, Bordeaux, France.'}, {'ForeName': 'Igor', 'Initials': 'I', 'LastName': 'Latorzeff', 'Affiliation': 'Clinique Pasteur Groupe Oncorad Garonne, Toulouse, France.'}, {'ForeName': 'Jean-Léon', 'Initials': 'JL', 'LastName': 'Lagrange', 'Affiliation': 'Henri Mondor Breast Center, Créteil, France.'}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Supiot', 'Affiliation': 'René Gauducheau cancer Institute, Nantes, France.'}, {'ForeName': 'Yazid', 'Initials': 'Y', 'LastName': 'Belkacemi', 'Affiliation': 'Department of Radiation Oncology and Henri Mondor Breast Center, University of Paris-Est, Créteil, France.'}, {'ForeName': 'Didier', 'Initials': 'D', 'LastName': 'Peiffert', 'Affiliation': 'Lorraine Cancer Institute, Alexis Vautrin Cancer Center, Université de Lorraine, Faculté de Médecine, Vandoeuvre-les-Nancy, France.'}, {'ForeName': 'Nedla', 'Initials': 'N', 'LastName': 'Allouache', 'Affiliation': 'François Baclesse Cancer Center, Caen, France.'}, {'ForeName': 'Bernard M', 'Initials': 'BM', 'LastName': 'Dubray', 'Affiliation': 'Henri Becquerel Cancer Center, Rouen, France.'}, {'ForeName': 'Stéphanie', 'Initials': 'S', 'LastName': 'Servagi-Vernat', 'Affiliation': 'Jean Godinot Institute, Reims, France.'}, {'ForeName': 'Jean-Philippe', 'Initials': 'JP', 'LastName': 'Suchaud', 'Affiliation': 'Radiotherapy Department, Roanne hospital center, Roanne, France.'}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Crehange', 'Affiliation': 'Georges-François Leclerc Cancer Center, Dijon, France.'}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Guerif', 'Affiliation': 'University hospital of Poitiers, Poitiers, France.'}, {'ForeName': 'Meryem', 'Initials': 'M', 'LastName': 'Brihoum', 'Affiliation': 'UNICANCER, Paris, France.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Barbier', 'Affiliation': 'Catalan Cancer Center, Perpignan, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Graff-Cailleaud', 'Affiliation': 'University Institute of Cancer Toulouse-Oncopôle, Toulouse, France.'}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Ruffion', 'Affiliation': 'Urology Department, Hospices Civils de Lyon, Pierre-Bénite, France.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Dussart', 'Affiliation': 'Biostatistics Unit, Clinical Research and Innovation Department, Léon Bérard Cancer Centre, Lyon, France.'}, {'ForeName': 'Céline', 'Initials': 'C', 'LastName': 'Ferlay', 'Affiliation': 'Biostatistics Unit, Clinical Research and Innovation Department, Léon Bérard Cancer Centre, Lyon, France.'}, {'ForeName': 'Sylvie', 'Initials': 'S', 'LastName': 'Chabaud', 'Affiliation': 'Biostatistics Unit, Clinical Research and Innovation Department, Léon Bérard Cancer Centre, Lyon, France.'}]",The Lancet. Oncology,['10.1016/S1470-2045(19)30486-3'] 315,30959514,Neurophysiological signature of gamma-hydroxybutyrate augmented sleep in male healthy volunteers may reflect biomimetic sleep enhancement: a randomized controlled trial.,"Gamma-hydroxybutyrate (GHB) is an endogenous GHB/GABA B receptor agonist, which has demonstrated potency in consolidating sleep and reducing excessive daytime sleepiness in narcolepsy. Little is known whether GHB's efficacy reflects the promotion of physiological sleep mechanisms and no study has investigated its sleep consolidating effects under low sleep pressure. GHB (50 mg/kg p.o.) and placebo were administered in 20 young male volunteers at 2:30 a.m., the time when GHB is typically given in narcolepsy, in a randomized, double-blinded, crossover manner. Drug effects on sleep architecture and electroencephalographic (EEG) sleep spectra were analyzed. In addition, current source density (CSD) analysis was employed to identify the effects of GHB on the brain electrical sources of neuronal oscillations. Moreover, lagged-phase synchronization (LPS) analysis was applied to quantify the functional connectivity among sleep-relevant brain regions. GHB prolonged slow-wave sleep (stage N3) at the cost of rapid eye movement (REM) sleep. Furthermore, it enhanced delta-theta (0.5-8 Hz) activity in NREM and REM sleep, while reducing activity in the spindle frequency range (13-15 Hz) in sleep stage N2. The increase in delta power predominated in medial prefrontal cortex, parahippocampal and fusiform gyri, and posterior cingulate cortex. Theta power was particularly increased in the prefrontal cortex and both temporal poles. Moreover, the brain areas that showed increased theta power after GHB also exhibited increased lagged-phase synchronization among each other. Our study in healthy men revealed distinct similarities between GHB-augmented sleep and physiologically augmented sleep as seen in recovery sleep after prolonged wakefulness. The promotion of the sleep neurophysiological mechanisms by GHB may thus provide a rationale for GHB-induced sleep and waking quality in neuropsychiatric disorders beyond narcolepsy.",2019,"The increase in delta power predominated in medial prefrontal cortex, parahippocampal and fusiform gyri, and posterior cingulate cortex.","['20 young male volunteers', 'healthy men', 'male healthy volunteers']","['gamma-hydroxybutyrate augmented sleep', 'placebo', 'GHB', 'Gamma-hydroxybutyrate (GHB']","['sleep architecture and electroencephalographic (EEG) sleep spectra', 'delta power predominated in medial prefrontal cortex, parahippocampal and fusiform gyri, and posterior cingulate cortex', 'biomimetic sleep enhancement', 'GHB prolonged slow-wave sleep (stage N3', 'Theta power']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0000503', 'cui_str': '4-Hydroxybutyrate (substance)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0003737', 'cui_str': 'Architecture'}, {'cui': 'C0439097', 'cui_str': 'Delta'}, {'cui': 'C0332251', 'cui_str': 'Predominate (qualifier value)'}, {'cui': 'C0205098', 'cui_str': 'Medial (qualifier value)'}, {'cui': 'C0162783', 'cui_str': 'Prefrontal Cortex'}, {'cui': 'C0228243', 'cui_str': 'Gyrus Fusiformis'}, {'cui': 'C0175191', 'cui_str': 'Posterior Cingulate'}, {'cui': 'C0872312', 'cui_str': 'Biomimicry Engineering'}, {'cui': 'C0184578', 'cui_str': 'Sleep/wake cycle facilitation'}, {'cui': 'C0000503', 'cui_str': '4-Hydroxybutyrate (substance)'}, {'cui': 'C0439590', 'cui_str': 'Prolonged (qualifier value)'}, {'cui': 'C0234451', 'cui_str': 'Sleep, Slow-Wave'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0439101', 'cui_str': 'Theta'}]",20.0,0.0596478,"The increase in delta power predominated in medial prefrontal cortex, parahippocampal and fusiform gyri, and posterior cingulate cortex.","[{'ForeName': 'Dario A', 'Initials': 'DA', 'LastName': 'Dornbierer', 'Affiliation': 'Institute of Pharmacology and Toxicology, University of Zürich, Zürich, Switzerland. dornbierer@pharma.uzh.ch.'}, {'ForeName': 'Diego M', 'Initials': 'DM', 'LastName': 'Baur', 'Affiliation': 'Institute of Pharmacology and Toxicology, University of Zürich, Zürich, Switzerland.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Stucky', 'Affiliation': 'Institute of Pharmacology and Toxicology, University of Zürich, Zürich, Switzerland.'}, {'ForeName': 'Boris B', 'Initials': 'BB', 'LastName': 'Quednow', 'Affiliation': 'Department of Psychiatry, Psychotherapy and Psychosomatics, Psychiatric Hospital, University of Zürich, Lenggstrasse 31, Zürich, CH-8032, Switzerland.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Kraemer', 'Affiliation': 'Department of Forensic Pharmacology and Toxicology, Zurich Institute of Forensic Medicine, University of Zürich, Zürich, Switzerland.'}, {'ForeName': 'Erich', 'Initials': 'E', 'LastName': 'Seifritz', 'Affiliation': 'Department of Psychiatry, Psychotherapy and Psychosomatics, Psychiatric Hospital, University of Zürich, Lenggstrasse 31, Zürich, CH-8032, Switzerland.'}, {'ForeName': 'Oliver G', 'Initials': 'OG', 'LastName': 'Bosch', 'Affiliation': 'Department of Psychiatry, Psychotherapy and Psychosomatics, Psychiatric Hospital, University of Zürich, Lenggstrasse 31, Zürich, CH-8032, Switzerland.'}, {'ForeName': 'Hans-Peter', 'Initials': 'HP', 'LastName': 'Landolt', 'Affiliation': 'Institute of Pharmacology and Toxicology, University of Zürich, Zürich, Switzerland.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0382-z'] 316,32286132,Enhanced Attention Using Head-mounted Virtual Reality.,"Some evidence suggests that experiencing a given scenario using virtual reality (VR) may engage greater attentional resources than experiencing the same scenario on a 2D computer monitor. However, the underlying neural processes associated with these VR-related effects, especially those pertaining to current consumer-friendly head-mounted displays of virtual reality (HMD-VR), remain unclear. Here, two experiments were conducted to compare task performance and EEG-based neural metrics captured during a perceptual discrimination task presented on two different viewing platforms. Forty participants (20-25 years old) completed this task using both an HMD-VR and traditional computer monitor in a within-group, randomized design. Although Experiment I ( n = 20) was solely behavioral in design, Experiment II ( n = 20) utilized combined EEG recordings to interrogate the neural correlates underlying potential performance differences across platforms. These experiments revealed that (1) there was no significant difference in the amount of arousal measured between platforms and (2) selective attention abilities in HMD-VR environment were enhanced from both a behavioral and neural perspective. These findings suggest that the allocation of attentional resources in HMD-VR may be superior to approaches more typically used to assess these abilities (e.g., desktop/laptop/tablet computers with 2D screens).",2020,"These findings suggest that the allocation of attentional resources in HMD-VR may be superior to approaches more typically used to assess these abilities (e.g., desktop/laptop/tablet computers with 2D screens).",['Forty participants (20-25 years old'],['HMD-VR and traditional computer monitor'],"['amount of arousal measured between platforms and (2) selective attention abilities in HMD-VR environment', 'attentional resources']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0030072', 'cui_str': 'Oxymetholone'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}]","[{'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0233421', 'cui_str': 'Selective inattention'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0030072', 'cui_str': 'Oxymetholone'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0035201', 'cui_str': 'Resources'}]",40.0,0.0169519,"These findings suggest that the allocation of attentional resources in HMD-VR may be superior to approaches more typically used to assess these abilities (e.g., desktop/laptop/tablet computers with 2D screens).","[{'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Li', 'Affiliation': 'Shanghai Jiao Tong University.'}, {'ForeName': 'Joaquin A', 'Initials': 'JA', 'LastName': 'Anguera', 'Affiliation': 'University of California, San Francisco.'}, {'ForeName': 'Samirah V', 'Initials': 'SV', 'LastName': 'Javed', 'Affiliation': 'University of California, San Francisco.'}, {'ForeName': 'Muḥammad Adeel', 'Initials': 'MA', 'LastName': 'Khan', 'Affiliation': 'Shanghai Jiao Tong University.'}, {'ForeName': 'Guoxing', 'Initials': 'G', 'LastName': 'Wang', 'Affiliation': 'Shanghai Jiao Tong University.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Gazzaley', 'Affiliation': 'University of California, San Francisco.'}]",Journal of cognitive neuroscience,['10.1162/jocn_a_01560'] 317,29286983,Aerobic Exercise Sustains Performance of Instrumental Activities of Daily Living in Early-Stage Alzheimer Disease.,"BACKGROUND AND PURPOSE Individuals with Alzheimer disease (AD) experience progressive loss of independence-performing activities of daily living. Identifying interventions to support independence and reduce the economic and psychosocial burden of caregiving for individuals with AD is imperative. The purpose of this analysis was to examine functional disability and caregiver time in individuals with early-stage AD. METHODS This was a secondary analysis of a randomized controlled trial of 26 weeks of aerobic exercise (AEx) versus stretching and toning (ST). We measured functional dependence using the Disability Assessment for Dementia, informal caregiver time required using the Resources Utilization in Dementia Lite, and cognition using a standard cognitive battery. RESULTS We saw a stable function in the AEx group compared with a significant decline in the ST group (4%; F = 4.2, P = .04). This was especially evident in more complex, instrumental activities of daily living, with individuals in the AEx group increasing 1% compared with an 8% loss in the ST group over 26 weeks (F = 8.3, P = .006). Change in memory was a significant predictor of declining instrumental activities of daily living performance (r = 0.28, 95% confidence interval = 0.08 ∞, P = .01). Informal caregiver time was not different between the AEx and ST groups. CONCLUSIONS Our analysis extends recent work by revealing specific benefits for instrumental activities of daily living for individuals in the early stages of AD and supports the value of exercise for individuals with cognitive impairment.",2019,"Change in memory was a significant predictor of declining instrumental activities of daily living performance (r = 0.28, 95% confidence interval = 0.08 ∞, P = .01).","['Individuals with Alzheimer disease (AD) experience progressive loss of independence-performing activities of daily living', 'Daily Living in Early-Stage Alzheimer Disease', 'individuals with early-stage AD', 'individuals with cognitive impairment']","['aerobic exercise (AEx) versus stretching and toning (ST', 'Aerobic Exercise']","['functional disability and caregiver time', 'instrumental activities of daily living performance', 'Informal caregiver time']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0002395', 'cui_str': 'Alzheimer Dementia'}, {'cui': 'C0205329', 'cui_str': 'Progressive (qualifier value)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0001288', 'cui_str': 'ADL'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C2363430', 'cui_str': 'Early stage (qualifier value)'}, {'cui': 'C0338656', 'cui_str': 'Cognitive Dysfunction'}]","[{'cui': 'C0001701', 'cui_str': 'Exercise, Aerobic'}, {'cui': 'C0600080', 'cui_str': 'Stretching procedure (procedure)'}]","[{'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1290928', 'cui_str': 'Instrumental activity of daily living (observable entity)'}]",,0.178348,"Change in memory was a significant predictor of declining instrumental activities of daily living performance (r = 0.28, 95% confidence interval = 0.08 ∞, P = .01).","[{'ForeName': 'Eric D', 'Initials': 'ED', 'LastName': 'Vidoni', 'Affiliation': ""University of Kansas Alzheimer's Disease Center, Fairway.""}, {'ForeName': 'Jaime', 'Initials': 'J', 'LastName': 'Perales', 'Affiliation': ""University of Kansas Alzheimer's Disease Center, Fairway.""}, {'ForeName': 'Mohammed', 'Initials': 'M', 'LastName': 'Alshehri', 'Affiliation': 'Department of Physical Therapy and Rehabilitation Science, University of Kansas Medical Center, Kansas City.'}, {'ForeName': 'Abdul-Mannaan', 'Initials': 'AM', 'LastName': 'Giles', 'Affiliation': 'Department of Medical Laboratory Sciences, Wichita State University, Kansas.'}, {'ForeName': 'Catherine F', 'Initials': 'CF', 'LastName': 'Siengsukon', 'Affiliation': 'Department of Physical Therapy and Rehabilitation Science, University of Kansas Medical Center, Kansas City.'}, {'ForeName': 'Jeffrey M', 'Initials': 'JM', 'LastName': 'Burns', 'Affiliation': ""University of Kansas Alzheimer's Disease Center, Fairway.""}]",Journal of geriatric physical therapy (2001),['10.1519/JPT.0000000000000172'] 318,31727538,"Optimal sequencing of enzalutamide and abiraterone acetate plus prednisone in metastatic castration-resistant prostate cancer: a multicentre, randomised, open-label, phase 2, crossover trial.","BACKGROUND Abiraterone acetate plus prednisone and enzalutamide are both used for the treatment of metastatic castration-resistant prostate cancer. We aimed to determine the best sequence in which to use both drugs, as well as their second-line efficacy. METHODS In this multicentre, randomised, open-label, phase 2, crossover trial done in six cancer centres in British Columbia, Canada, we recruited patients aged 18 years or older with newly-diagnosed metastatic castration-resistant prostate cancer without neuroendocrine differentiation and Eastern Cooperative Oncology Group performance status 2 or less. Patients were randomly assigned (1:1) using a computer-generated random number table to receive either abiraterone acetate 1000 mg orally once daily plus prednisone 5 mg orally twice daily until PSA progression followed by crossover to enzalutamide 160 mg orally once daily (group A), or the opposite sequence (group B). Treatment was not masked to investigators or participants. Primary endpoints were time to second PSA progression and PSA response (≥30% decline from baseline) on second-line therapy, analysed by intention-to-treat in all randomly assigned patients and in patients who crossed over, respectively. The trial is registered with ClinicalTrials.gov, NCT02125357. FINDINGS Between Oct 21, 2014, and Dec 13, 2016, 202 patients were enrolled and randomly assigned to either group A (n=101) or group B (n=101). At the time of data cutoff, 73 (72%) patients in group A and 75 (74%) patients in group B had crossed over. Time to second PSA progression was longer in group A than in group B (median 19·3 months [95% CI 16·0-30·5] vs 15·2 months [95% CI 11·9-19·8] months; hazard ratio 0·66, 95% CI 0·45-0·97, p=0·036), at a median follow-up of 22·8 months (IQR 10·3-33·4). PSA responses to second-line therapy were seen in 26 (36%) of 73 patients for enzalutamide and three (4%) of 75 for abiraterone (χ 2 p<0·0001). The most common grade 3-4 adverse events throughout the trial were hypertension (27 [27%] of 101 patients in group A vs 18 [18%] of 101 patients in group B) and fatigue (six [10%] vs four [4%]). Serious adverse events were reported in 15 (15%) of 101 patients in group A and 20 (20%) of 101 patients in group B. There were no treatment-related deaths. INTERPRETATION Enzalutamide showed activity as a second-line novel androgen receptor pathway inhibitor, whereas abiraterone acetate did not, leading to a longer time to second PSA progression for the sequence of abiraterone followed by enzalutamide than with the opposite treatment sequence. Our data suggest that using a sequencing strategy of abiraterone acetate followed by enzalutamide provides the greatest clinical benefit. FUNDING Canadian Cancer Society Research Institute, Prostate Cancer Canada, Movember Foundation, Prostate Cancer Foundation, Terry Fox New Frontiers Program, BC Cancer Foundation, Jane and Aatos Erkko Foundation, Janssen, and Astellas.",2019,PSA responses to second-line therapy were seen in 26 (36%) of 73 patients for enzalutamide and three (4%) of 75 for abiraterone (χ 2 p<0·0001).,"['six cancer centres in British Columbia, Canada, we recruited patients aged 18 years or older with newly-diagnosed metastatic castration-resistant prostate cancer without neuroendocrine differentiation and Eastern Cooperative Oncology Group performance status 2 or less', 'metastatic castration-resistant prostate cancer', 'Between Oct 21, 2014, and Dec 13, 2016, 202 patients']","['Abiraterone acetate plus prednisone and enzalutamide', 'enzalutamide', 'enzalutamide and abiraterone acetate plus prednisone', 'abiraterone acetate', 'abiraterone acetate 1000 mg orally once daily plus prednisone']","['Time to second PSA progression', 'PSA responses', 'Serious adverse events', 'fatigue', 'time to second PSA progression and PSA response']","[{'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0006193', 'cui_str': 'British Columbia'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C4721208', 'cui_str': 'Metastatic castration-resistant prostate cancer'}, {'cui': 'C0332288', 'cui_str': 'Without (attribute)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C1520224', 'cui_str': 'Eastern Cooperative Oncology Group performance status'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}]","[{'cui': 'C2607886', 'cui_str': 'abiraterone acetate'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C3496793', 'cui_str': 'enzalutamide'}, {'cui': 'C1883310', 'cui_str': '1000 (qualifier value)'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0201544', 'cui_str': 'Prostate specific antigen measurement (procedure)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}]",202.0,0.17203,PSA responses to second-line therapy were seen in 26 (36%) of 73 patients for enzalutamide and three (4%) of 75 for abiraterone (χ 2 p<0·0001).,"[{'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Khalaf', 'Affiliation': 'Division of Medical Oncology, BC Cancer, Vancouver, BC, Canada.'}, {'ForeName': 'Matti', 'Initials': 'M', 'LastName': 'Annala', 'Affiliation': 'Vancouver Prostate Centre, Vancouver, BC, Canada; Faculty of Medicine and Health Technology, Tampere University, Tampere, Finland.'}, {'ForeName': 'Sinja', 'Initials': 'S', 'LastName': 'Taavitsainen', 'Affiliation': 'Vancouver Prostate Centre, Vancouver, BC, Canada; Faculty of Medicine and Health Technology, Tampere University, Tampere, Finland.'}, {'ForeName': 'Daygen L', 'Initials': 'DL', 'LastName': 'Finch', 'Affiliation': 'BC Cancer, Kelowna, BC, Canada.'}, {'ForeName': 'Conrad', 'Initials': 'C', 'LastName': 'Oja', 'Affiliation': 'BC Cancer, Surrey, BC, Canada.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Vergidis', 'Affiliation': 'BC Cancer, Victoria, BC, Canada.'}, {'ForeName': 'Muhammad', 'Initials': 'M', 'LastName': 'Zulfiqar', 'Affiliation': 'BC Cancer, Abbotsford, BC, Canada.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Sunderland', 'Affiliation': 'Division of Cancer Surveillance and Outcomes, BC Cancer, Vancouver, BC, Canada.'}, {'ForeName': 'Arun A', 'Initials': 'AA', 'LastName': 'Azad', 'Affiliation': 'Peter MacCallum Cancer Centre, Melbourne, VIC, Australia.'}, {'ForeName': 'Christian K', 'Initials': 'CK', 'LastName': 'Kollmannsberger', 'Affiliation': 'Division of Medical Oncology, BC Cancer, Vancouver, BC, Canada.'}, {'ForeName': 'Bernhard J', 'Initials': 'BJ', 'LastName': 'Eigl', 'Affiliation': 'Division of Medical Oncology, BC Cancer, Vancouver, BC, Canada.'}, {'ForeName': 'Krista', 'Initials': 'K', 'LastName': 'Noonan', 'Affiliation': 'BC Cancer, Surrey, BC, Canada.'}, {'ForeName': 'Deepa', 'Initials': 'D', 'LastName': 'Wadhwa', 'Affiliation': 'BC Cancer, Kelowna, BC, Canada.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Attwell', 'Affiliation': 'BC Cancer, Victoria, BC, Canada.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Keith', 'Affiliation': 'BC Cancer, Abbotsford, BC, Canada.'}, {'ForeName': 'Susan L', 'Initials': 'SL', 'LastName': 'Ellard', 'Affiliation': 'BC Cancer, Kelowna, BC, Canada.'}, {'ForeName': 'Lyly', 'Initials': 'L', 'LastName': 'Le', 'Affiliation': 'BC Cancer, Surrey, BC, Canada.'}, {'ForeName': 'Martin E', 'Initials': 'ME', 'LastName': 'Gleave', 'Affiliation': 'Vancouver Prostate Centre, Vancouver, BC, Canada.'}, {'ForeName': 'Alexander W', 'Initials': 'AW', 'LastName': 'Wyatt', 'Affiliation': 'Vancouver Prostate Centre, Vancouver, BC, Canada.'}, {'ForeName': 'Kim N', 'Initials': 'KN', 'LastName': 'Chi', 'Affiliation': 'Division of Medical Oncology, BC Cancer, Vancouver, BC, Canada; Vancouver Prostate Centre, Vancouver, BC, Canada. Electronic address: kchi@bccancer.bc.ca.'}]",The Lancet. Oncology,['10.1016/S1470-2045(19)30688-6'] 319,31103018,Neural and behavioral effects of oxytocin administration during theory of mind in schizophrenia and controls: a randomized control trial.,"Social cognitive impairments, including theory of mind (ToM), in schizophrenia more strongly predict functional outcomes than psychotic symptoms or nonsocial cognitive deficits. Despite their clinical importance, current medications do not improve these deficits. The current study investigated the hypothesis that oxytocin, a neuropeptide implicated in social behavior, would normalize neural abnormalities in schizophrenia during ToM, and that this normalization would correlate improvement in ToM behavior. In this cross-over, double-blind, and placebo-controlled functional magnetic resonance imaging study, a single dose of 40 IU of oxytocin was administered via nasal spray to male individuals with a schizophrenia spectrum disorder (schizophrenia and schizoaffective disorder, n = 23) and healthy controls (n = 25). Participants completed two ToM tasks in the scanner, the False Belief and Person Description tasks. During both tasks, on placebo day, schizophrenia was associated with reduced accuracy, hypo-activity in the right temporo-parietal junction (rTPJ; extended into the posterior superior temporal sulcus), and hypo-connectivity between the rTPJ and medial prefrontal cortex (mPFC) compared to healthy controls. Oxytocin, relative to placebo, significantly increased accuracy and rTPJ activation for ToM but not control stories in schizophrenia. Furthermore, a significant positive correlation was found between oxytocin induced increases in rTPJ activity and accuracy, indicating that oxytocin improved rTPJ activity in schizophrenia predicted behavioral improvement. Oxytocin also significantly improved connectivity between rTPJ and mPFC in schizophrenia. These findings suggest that rTPJ activity during ToM might be a potential neural target for the treatment of social cognitive deficits in schizophrenia.",2019,"During both tasks, on placebo day, schizophrenia was associated with reduced accuracy, hypo-activity in the right temporo-parietal junction (rTPJ; extended into the posterior superior temporal sulcus), and hypo-connectivity between the rTPJ and medial prefrontal cortex (mPFC) compared to healthy controls.","['schizophrenia and controls', 'male\xa0individuals with a schizophrenia spectrum disorder (schizophrenia and schizoaffective disorder, n\u2009=\u200923) and healthy controls (n\u2009=\u200925']","['Oxytocin', 'placebo', 'oxytocin']","['rTPJ activity and accuracy', 'accuracy and rTPJ activation', 'Social cognitive impairments, including theory of mind (ToM', 'connectivity', 'reduced accuracy, hypo-activity', 'rTPJ activity']","[{'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0036337', 'cui_str': 'Schizoaffective Disorder'}]","[{'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0338656', 'cui_str': 'Cognitive Dysfunction'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0935573', 'cui_str': 'Mentalizing'}]",,0.12082,"During both tasks, on placebo day, schizophrenia was associated with reduced accuracy, hypo-activity in the right temporo-parietal junction (rTPJ; extended into the posterior superior temporal sulcus), and hypo-connectivity between the rTPJ and medial prefrontal cortex (mPFC) compared to healthy controls.","[{'ForeName': 'Lize', 'Initials': 'L', 'LastName': 'De Coster', 'Affiliation': 'University of California, San Francisco, CA, USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Lin', 'Affiliation': 'University of California, San Francisco, CA, USA.'}, {'ForeName': 'Daniel H', 'Initials': 'DH', 'LastName': 'Mathalon', 'Affiliation': 'University of California, San Francisco, CA, USA.'}, {'ForeName': 'Joshua D', 'Initials': 'JD', 'LastName': 'Woolley', 'Affiliation': 'University of California, San Francisco, CA, USA. josh.woolley@ucsf.edu.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0417-5'] 320,31112370,Impact of Intensive Lifestyle Intervention on Neural Food Cue Reactivity: Action for Health in Diabetes Brain Ancillary Study.,"OBJECTIVE The Action for Health in Diabetes (Look AHEAD) research study was a randomized trial comparing the effects of an intensive lifestyle intervention (ILI) versus a diabetes support and education (DSE) control group in adults with type 2 diabetes and overweight or obesity. Functional magnetic resonance imaging was used to determine whether neural food cue reactivity differed for these groups 10 years after randomization. METHODS A total of 232 participants (ILI, n = 125, 72% female; DSE, n = 107, 64% female) were recruited at three of the Look AHEAD sites for functional magnetic resonance imaging. Neural response to high-calorie foods compared with nonfoods was assessed in DSE versus ILI. Exploratory correlations were conducted within ILI to identify regions in which activity was associated with degree of weight loss. RESULTS Voxel-wise whole-brain comparisons revealed greater reward-processing activity in left caudate for DSE compared with ILI and greater activity in attention- and visual-processing regions for ILI than DSE (P < 0.05, family-wise error corrected). Exploratory analyses revealed that greater weight loss among ILI participants from baseline was associated with brain activation indicative of increased cognitive control and attention and visual processing in response to high-calorie food cues (P < 0.001, uncorrected). CONCLUSIONS These findings suggest there may be legacy effects of participation in a behavioral weight loss intervention, with reduced reward-related activity and enhanced attention or visual processing in response to high-calorie foods.",2019,"Exploratory analyses revealed that greater weight loss among ILI participants from baseline was associated with brain activation indicative of increased cognitive control and attention and visual processing in response to high-calorie food cues (P < 0.001, uncorrected). ","['adults with type 2 diabetes and overweight or obesity', '232 participants (ILI, n\u2009=\u2009125, 72% female; DSE, n\u2009=\u2009107, 64% female', 'Diabetes']","['intensive lifestyle intervention (ILI) versus a diabetes support and education (DSE) control group', 'Intensive Lifestyle Intervention']","['weight loss', 'brain activation indicative of increased cognitive control and attention and visual processing', 'reward-processing activity', 'Neural response', 'neural food cue reactivity']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C4319551', 'cui_str': 'One hundred and twenty-five'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C4517529', 'cui_str': 'One hundred and seven'}]","[{'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0589087', 'cui_str': 'Visual processing, function (observable entity)'}, {'cui': 'C0035397', 'cui_str': 'Rewards'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0010439', 'cui_str': 'Cues'}]",232.0,0.0712925,"Exploratory analyses revealed that greater weight loss among ILI participants from baseline was associated with brain activation indicative of increased cognitive control and attention and visual processing in response to high-calorie food cues (P < 0.001, uncorrected). ","[{'ForeName': 'Kathryn Demos', 'Initials': 'KD', 'LastName': 'McDermott', 'Affiliation': 'Department of Psychiatry and Human Behavior, Warren Alpert Medical School of Brown University, The Miriam Hospital/Weight Control and Diabetes Research Center, Providence, Rhode Island, USA.'}, {'ForeName': 'Samantha E', 'Initials': 'SE', 'LastName': 'Williams', 'Affiliation': 'Department of Psychiatry and Human Behavior, Warren Alpert Medical School of Brown University, The Miriam Hospital/Weight Control and Diabetes Research Center, Providence, Rhode Island, USA.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Espeland', 'Affiliation': 'Department of Biostatistical Sciences, Wake Forest School of Medicine, Winston-Salem, North Carolina, USA.'}, {'ForeName': 'Kirk', 'Initials': 'K', 'LastName': 'Erickson', 'Affiliation': 'Department of Psychology, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Neiberg', 'Affiliation': 'Department of Psychology, Saint Louis University, St. Louis, Missouri, USA.'}, {'ForeName': 'Thomas A', 'Initials': 'TA', 'LastName': 'Wadden', 'Affiliation': 'Department of Radiology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'R Nick', 'Initials': 'RN', 'LastName': 'Bryan', 'Affiliation': 'Department of Radiology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Desiderio', 'Affiliation': 'Department of Radiology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Regina L', 'Initials': 'RL', 'LastName': 'Leckie', 'Affiliation': 'Department of Psychology, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Lucy H', 'Initials': 'LH', 'LastName': 'Falconbridge', 'Affiliation': 'Department of Radiology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Jakicic', 'Affiliation': 'Department of Health and Physical Activity, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Alonso-Alonso', 'Affiliation': 'Department of Surgery, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Rena R', 'Initials': 'RR', 'LastName': 'Wing', 'Affiliation': 'Department of Psychiatry and Human Behavior, Warren Alpert Medical School of Brown University, The Miriam Hospital/Weight Control and Diabetes Research Center, Providence, Rhode Island, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Obesity (Silver Spring, Md.)",['10.1002/oby.22496'] 321,32286620,Early Child Development Outcomes of a Randomized Trial Providing 1 Egg Per Day to Children Age 6 to 15 Months in Malawi.,"BACKGROUND Eggs are a rich source of nutrients important for brain development, including choline, riboflavin, vitamins B-6 and B-12, folate, zinc, protein, and DHA. OBJECTIVE Our objective was to evaluate the effect of the consumption of 1 egg per day over a 6-mo period on child development. METHODS In the Mazira Project randomized controlled trial, 660 children aged 6-9 mo were randomly allocated into an intervention or control group. Eggs were provided to intervention households during twice-weekly home visits for 6 mo. Control households were visited at the same frequency. At enrollment, blinded assessors administered the Malawi Developmental Assessment Tool (MDAT), and 2 eye-tracking tasks using a Tobii-Pro X2-60 eye tracker: a visual paired comparison memory task and an Infant Orienting with Attention task. At endline, 6-mo later, blinded assessors administered the MDAT and eye-tracking tasks plus an additional elicited imitation memory task. RESULTS At endline, intervention and control groups did not significantly differ in any developmental score, with the exception that a smaller percentage of children were delayed in fine motor development in the intervention group (10.6%) compared with the control group (16.5%; prevalence ratio: 0.59, 95% CI: 0.38-0.91). Among 10 prespecified effect modifiers for the 8 primary developmental outcomes, we found 7 significant interactions demonstrating a consistent pattern that children who were less vulnerable, for example, those with higher household wealth and maternal education, showed positive effects of the intervention. Given multiple hypothesis testing, some findings may have been due to chance. CONCLUSION The provision of 1 egg per day had no overall effect on child development in this population of children, however, some benefits may be seen among children in less vulnerable circumstances. This trial was registered at clinicaltrials.gov as NCT03385252.",2020,"At endline, intervention and control groups did not significantly differ in any developmental score, with the exception that a smaller percentage of children were delayed in fine motor development in the intervention group (10.6%) compared with the control group (16.5%; prevalence ratio: 0.59, 95% CI: 0.38-0.91).",['660 children aged 6-9 mo'],"['Malawi Developmental Assessment Tool (MDAT), and 2 eye-tracking tasks using a Tobii-Pro X2-60 eye tracker: a visual paired comparison memory task and an Infant Orienting with Attention task']","['developmental score', 'fine motor development']","[{'cui': 'C4517845', 'cui_str': '660'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0442751', 'cui_str': 'Distance vision 6/9'}]","[{'cui': 'C0024548', 'cui_str': 'Malawi'}, {'cui': 'C0458003', 'cui_str': 'Developmental'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0086766', 'cui_str': 'Paired Comparisons'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C1704322', 'cui_str': 'Spatial orientation'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]","[{'cui': 'C0458003', 'cui_str': 'Developmental'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205232', 'cui_str': 'Fine'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}]",660.0,0.253052,"At endline, intervention and control groups did not significantly differ in any developmental score, with the exception that a smaller percentage of children were delayed in fine motor development in the intervention group (10.6%) compared with the control group (16.5%; prevalence ratio: 0.59, 95% CI: 0.38-0.91).","[{'ForeName': 'Elizabeth L', 'Initials': 'EL', 'LastName': 'Prado', 'Affiliation': 'Department of Nutrition and Institute for Global Nutrition, University of California Davis, Davis, CA, USA.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Maleta', 'Affiliation': 'School of Public Health and Family Medicine, University of Malawi College of Medicine, Blantyre, Malawi.'}, {'ForeName': 'Bess L', 'Initials': 'BL', 'LastName': 'Caswell', 'Affiliation': 'Department of Nutrition and Institute for Global Nutrition, University of California Davis, Davis, CA, USA.'}, {'ForeName': 'Matthews', 'Initials': 'M', 'LastName': 'George', 'Affiliation': 'School of Public Health and Family Medicine, University of Malawi College of Medicine, Blantyre, Malawi.'}, {'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'Oakes', 'Affiliation': 'Department of Psychology and Center for Mind and Brain, University of California Davis, Davis, CA, USA.'}, {'ForeName': 'Michaela C', 'Initials': 'MC', 'LastName': 'DeBolt', 'Affiliation': 'Department of Psychology and Center for Mind and Brain, University of California Davis, Davis, CA, USA.'}, {'ForeName': 'Megan G', 'Initials': 'MG', 'LastName': 'Bragg', 'Affiliation': 'Department of Nutrition and Institute for Global Nutrition, University of California Davis, Davis, CA, USA.'}, {'ForeName': 'Charles D', 'Initials': 'CD', 'LastName': 'Arnold', 'Affiliation': 'Department of Nutrition and Institute for Global Nutrition, University of California Davis, Davis, CA, USA.'}, {'ForeName': 'Lora L', 'Initials': 'LL', 'LastName': 'Iannotti', 'Affiliation': 'Brown School, Institute for Public Health, Washington University in St. Louis, St. Louis, MO, USA.'}, {'ForeName': 'Chessa K', 'Initials': 'CK', 'LastName': 'Lutter', 'Affiliation': 'RTI International, Washington DC, School of Public Health, University of Maryland, College Park, MD, USA.'}, {'ForeName': 'Christine P', 'Initials': 'CP', 'LastName': 'Stewart', 'Affiliation': 'Department of Nutrition and Institute for Global Nutrition, University of California Davis, Davis, CA, USA.'}]",The Journal of nutrition,['10.1093/jn/nxaa088'] 322,32284181,Effect of probiotics on gut microbiome in patients with administration of surgical antibiotic prophylaxis: A randomized controlled study.,"Surgical antibiotic prophylaxis (SAP) is recommended for the prevention of surgical site infections. However, there is a concern about adverse effects of SAP, such as antibiotic-associated diarrhea (AAD). To prevent AAD, administration of probiotics has been investigated. Although recent advances in next-generation sequencing makes it possible to analyze the gut microbiome, the effect of probiotics on the gut microbiome in the patients with SAP remains unknown. To test a hypothesis that SAP influences the gut microbiome and probiotics prevent the influence, a randomized controlled study was conducted with patients who underwent spinal surgery at Nagasaki University Hospital. After obtaining informed consent, the patients were automatically classified into the non-probiotics group and the probiotics group. In the probiotics group, the patients took 1 g of Enterococcus faecium 129 BIO 3B-R, 3 times a day on postoperative days (PODs) 1-5. The feces of all patients were sampled before administration of SAP and on PODs 5 and 10. We compared alpha and beta diversity and differential abundance analysis of the gut microbiome before and after SAP. During the study period, a total of 33 patients were evaluated, comprising 17 patients in the non-probiotics group and 16 in the probiotics group. There was no significant difference between the groups regarding patient characteristics. In alpha and beta diversity, there were no significant differences among all combinations. In differential abundance analysis at operational taxonomic unit level, Streptococcus gallolyticus and Roseburia were significantly increased in the non-probiotics group and significantly decreased in the probiotics group.",2020,"In differential abundance analysis at operational taxonomic unit level, Streptococcus gallolyticus and Roseburia were significantly increased in the non-probiotics group and significantly decreased in the probiotics group.","['33 patients were evaluated, comprising 17 patients in the non-probiotics group and 16 in the probiotics group', 'patients with administration of surgical antibiotic prophylaxis', 'patients who underwent spinal surgery at Nagasaki University Hospital']","['probiotics', 'Surgical antibiotic prophylaxis (SAP']","['operational taxonomic unit level, Streptococcus gallolyticus and Roseburia']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0282638', 'cui_str': 'Antibiotic prophylaxis'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}]","[{'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0282638', 'cui_str': 'Antibiotic prophylaxis'}]","[{'cui': 'C0008903', 'cui_str': 'classification'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1017328', 'cui_str': 'Streptococcus gallolyticus'}, {'cui': 'C0995401', 'cui_str': 'Roseburia'}]",33.0,0.0277709,"In differential abundance analysis at operational taxonomic unit level, Streptococcus gallolyticus and Roseburia were significantly increased in the non-probiotics group and significantly decreased in the probiotics group.","[{'ForeName': 'Norihito', 'Initials': 'N', 'LastName': 'Kaku', 'Affiliation': 'Department of Laboratory Medicine, Nagasaki University Hospital, Nagasaki, Japan; Department of Laboratory Medicine, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan. Electronic address: kaku-ngs@umin.ac.jp.'}, {'ForeName': 'Nariyoshi', 'Initials': 'N', 'LastName': 'Matsumoto', 'Affiliation': 'Department of Laboratory Medicine, Nagasaki University Hospital, Nagasaki, Japan.'}, {'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Sasaki', 'Affiliation': 'Department of Laboratory Medicine, Nagasaki University Hospital, Nagasaki, Japan.'}, {'ForeName': 'Keiichi', 'Initials': 'K', 'LastName': 'Tsuda', 'Affiliation': 'Department of Orthopaedic Surgery, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan.'}, {'ForeName': 'Kosuke', 'Initials': 'K', 'LastName': 'Kosai', 'Affiliation': 'Department of Laboratory Medicine, Nagasaki University Hospital, Nagasaki, Japan; Department of Laboratory Medicine, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan.'}, {'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Uno', 'Affiliation': 'Department of Laboratory Medicine, Nagasaki University Hospital, Nagasaki, Japan; Department of Laboratory Medicine, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan.'}, {'ForeName': 'Yoshitomo', 'Initials': 'Y', 'LastName': 'Morinaga', 'Affiliation': 'Department of Laboratory Medicine, Nagasaki University Hospital, Nagasaki, Japan; Department of Laboratory Medicine, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Tagami', 'Affiliation': 'Department of Orthopaedic Surgery, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan.'}, {'ForeName': 'Shinji', 'Initials': 'S', 'LastName': 'Adachi', 'Affiliation': 'Department of Orthopaedic Surgery, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan.'}, {'ForeName': 'Hiroo', 'Initials': 'H', 'LastName': 'Hasegawa', 'Affiliation': 'Department of Laboratory Medicine, Nagasaki University Hospital, Nagasaki, Japan; Department of Laboratory Medicine, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan.'}, {'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Osaki', 'Affiliation': 'Department of Orthopaedic Surgery, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan.'}, {'ForeName': 'Katsunori', 'Initials': 'K', 'LastName': 'Yanagihara', 'Affiliation': 'Department of Laboratory Medicine, Nagasaki University Hospital, Nagasaki, Japan; Department of Laboratory Medicine, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki, Japan.'}]",Journal of infection and chemotherapy : official journal of the Japan Society of Chemotherapy,['10.1016/j.jiac.2020.03.008'] 323,32286687,Patient-reported outcomes from KATHERINE: A phase 3 study of adjuvant trastuzumab emtansine versus trastuzumab in patients with residual invasive disease after neoadjuvant therapy for human epidermal growth factor receptor 2-positive breast cancer.,"BACKGROUND The phase 3 KATHERINE trial demonstrated significantly improved invasive disease-free survival with adjuvant trastuzumab emtansine (T-DM1) versus trastuzumab in patients with HER2-positive early breast cancer and residual invasive disease after neoadjuvant chemotherapy plus HER2-targeted therapy. METHODS Patients who received taxane- and trastuzumab-containing neoadjuvant therapy (with/without anthracyclines) and had residual invasive disease (breast and/or axillary nodes) at surgery were randomly assigned to 14 cycles of adjuvant T-DM1 (3.6 mg/kg intravenously every 3 weeks) or trastuzumab (6 mg/kg intravenously every 3 weeks). The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (QLQ-C30) and breast cancer module (QLQ-BR23) were completed at screening, at day 1 of cycles 5 and 11, within 30 days after study drug completion, and at 6- and 12-month follow-up visits. RESULTS Of patients who were randomly assigned to T-DM1 (n = 743) and trastuzumab (n = 743), 612 (82%) and 640 (86%), respectively, had valid baseline and ≥1 postbaseline assessments. No clinically meaningful changes (≥10 points) from baseline in mean QLQ-C30 and QLQ-BR23 scores occurred in either arm. More patients receiving T-DM1 reported clinically meaningful deterioration at any assessment point in role functioning (49% vs 41%), appetite loss (38% vs 28%), constipation (47% vs 38%), fatigue (66% vs 60%), nausea/vomiting (39% vs 30%), and systemic therapy side effects (49% vs 36%). These differences were no longer apparent at the 6-month follow-up assessment, except for role functioning (23% vs 16%). CONCLUSION These data suggest that health-related quality of life was generally maintained in both study arms over the course of treatment.",2020,No clinically meaningful changes (≥10 points) from baseline in mean QLQ-C30 and QLQ-BR23 scores occurred in either arm.,"['Patients who received', 'patients with residual invasive disease after neoadjuvant therapy for human epidermal growth factor receptor 2-positive breast cancer', 'patients with HER2-positive early breast cancer and residual invasive disease after neoadjuvant chemotherapy plus HER2-targeted therapy', 'with/without anthracyclines) and had residual invasive disease (breast and/or axillary nodes) at surgery']","['adjuvant trastuzumab emtansine versus trastuzumab', 'adjuvant T-DM1', 'adjuvant trastuzumab emtansine (T-DM1) versus trastuzumab', 'taxane- and trastuzumab-containing neoadjuvant therapy', 'trastuzumab']","['meaningful deterioration', 'appetite loss', 'mean QLQ-C30 and QLQ-BR23 scores', 'invasive disease-free survival', 'systemic therapy side effects', 'Cancer Quality of Life Questionnaire-Core 30 (QLQ-C30) and breast cancer module (QLQ-BR23', 'fatigue', 'constipation', 'quality of life', 'nausea/vomiting']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0242957', 'cui_str': 'Genes, erbb2'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0069515', 'cui_str': 'Oncogene protein HER-2/neu'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0003234', 'cui_str': 'Anthracycline'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0729594', 'cui_str': 'Axillary lymph node group'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C2935436', 'cui_str': 'ado-trastuzumab emtansine'}, {'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C0215136', 'cui_str': 'taxane'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}]","[{'cui': 'C0003123', 'cui_str': 'Anorexia'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C3542953', 'cui_str': 'Module'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}]",743.0,0.0808795,No clinically meaningful changes (≥10 points) from baseline in mean QLQ-C30 and QLQ-BR23 scores occurred in either arm.,"[{'ForeName': 'PierFranco', 'Initials': 'P', 'LastName': 'Conte', 'Affiliation': 'DiSCOG, University of Padova and Division of Medical Oncology 2, Istituto Oncologico Veneto, IRCCS, Padova, Italy.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Schneeweiss', 'Affiliation': 'National Center for Tumor Diseases, Heidelberg University Hospital and German Cancer Research Center, Heidelberg, Germany.'}, {'ForeName': 'Sibylle', 'Initials': 'S', 'LastName': 'Loibl', 'Affiliation': 'GBG, Neu-Isenburg, Germany.'}, {'ForeName': 'Eleftherios P', 'Initials': 'EP', 'LastName': 'Mamounas', 'Affiliation': 'NSABP Foundation and Orlando Health University of Florida Health Cancer Center, Orlando, Florida.'}, {'ForeName': 'Gunter', 'Initials': 'G', 'LastName': 'von Minckwitz', 'Affiliation': 'GBG, Neu-Isenburg, Germany.'}, {'ForeName': 'Max S', 'Initials': 'MS', 'LastName': 'Mano', 'Affiliation': 'Instituto do Câncer do Estado de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Untch', 'Affiliation': 'AGO-B and HELIOS Klinikum Berlin Buch, Berlin, Germany.'}, {'ForeName': 'Chiun-Sheng', 'Initials': 'CS', 'LastName': 'Huang', 'Affiliation': 'National Taiwan University Hospital and National Taiwan University College of Medicine, Taipei, Taiwan.'}, {'ForeName': 'Norman', 'Initials': 'N', 'LastName': 'Wolmark', 'Affiliation': 'NSABP Foundation and University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Priya', 'Initials': 'P', 'LastName': 'Rastogi', 'Affiliation': 'NSABP Foundation and University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Veronique', 'Initials': 'V', 'LastName': ""D'Hondt"", 'Affiliation': 'Institut Régional du Cancer de Montpellier, Montpellier, France.'}, {'ForeName': 'Andrés', 'Initials': 'A', 'LastName': 'Redondo', 'Affiliation': 'Hospital Universitario La Paz-IdiPAZ, Madrid, Spain.'}, {'ForeName': 'Ljiljana', 'Initials': 'L', 'LastName': 'Stamatovic', 'Affiliation': 'Institute for Oncology and Radiology of Serbia, Belgrade, Serbia.'}, {'ForeName': 'Hervé', 'Initials': 'H', 'LastName': 'Bonnefoi', 'Affiliation': 'Institut Bergonié Unicancer and Bordeaux University, Bordeaux, France.'}, {'ForeName': 'Hugo', 'Initials': 'H', 'LastName': 'Castro-Salguero', 'Affiliation': 'Grupo Medico Angeles, Guatemala City, Guatemala.'}, {'ForeName': 'Hans H', 'Initials': 'HH', 'LastName': 'Fischer', 'Affiliation': 'GBG and Evangelische Kliniken Gelsenkirchen, Gelsenkirchen, Germany.'}, {'ForeName': 'Tanya', 'Initials': 'T', 'LastName': 'Wahl', 'Affiliation': 'Swedish Cancer Institute, Issaquah, Washington.'}, {'ForeName': 'Chunyan', 'Initials': 'C', 'LastName': 'Song', 'Affiliation': 'Genentech, Inc., South San Francisco, California.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Boulet', 'Affiliation': 'F. Hoffmann-La Roche, Basel, Switzerland.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Trask', 'Affiliation': 'Genentech, Inc., South San Francisco, California.'}, {'ForeName': 'Charles E', 'Initials': 'CE', 'LastName': 'Geyer', 'Affiliation': 'NSABP Foundation and Houston Methodist Cancer Center, Houston, Texas.'}]",Cancer,['10.1002/cncr.32873'] 324,31180829,Assessment of the Efficacy of EEG-Based MI-BCI With Visual Feedback and EEG Correlates of Mental Fatigue for Upper-Limb Stroke Rehabilitation.,"OBJECTIVE This single-arm multisite trial investigates the efficacy of the neurostyle brain exercise therapy towards enhanced recovery (nBETTER) system, an electroencephalogram (EEG)-based motor imagery brain-computer interface (MI-BCI) employing visual feedback for upper-limb stroke rehabilitation, and the presence of EEG correlates of mental fatigue during BCI usage. METHODS A total of 13 recruited stroke patients underwent thrice-weekly nBETTER therapy coupled with standard arm therapy over six weeks. Upper-extremity Fugl-Meyer motor assessment (FMA) scores were measured at baseline (week 0), post-intervention (week 6), and follow-ups (weeks 12 and 24). In total, 11/13 patients (mean age 55.2 years old, mean post-stroke duration 333.7 days, mean baseline FMA 35.5) completed the study. RESULTS Significant FMA gains relative to baseline were observed at weeks 6 and 24. Retrospectively comparing to the standard arm therapy (SAT) control group and BCI with haptic knob (BCI-HK) intervention group from a previous similar study, the SAT group had no significant gains, whereas the BCI-HK group had significant gains at weeks 6, 12, and 24. EEG analysis revealed significant positive correlations between relative beta power and BCI performance in the frontal and central brain regions, suggesting that mental fatigue may contribute to poorer BCI performance. CONCLUSION nBETTER, an EEG-based MI-BCI employing only visual feedback, helps stroke survivors sustain short-term FMA improvement. Analysis of EEG relative beta power indicates that mental fatigue may be present. SIGNIFICANCE This study adds nBETTER to the growing literature of safe and effective stroke rehabilitation MI-BCI, and suggests an additional fatigue-monitoring role in future such BCI.",2020,"EEG analysis revealed significant positive correlations between relative beta power and BCI performance in the frontal and central brain regions, suggesting that mental fatigue may contribute to poorer BCI performance. ","['Mental Fatigue for Upper-Limb Stroke Rehabilitation', '11/13 patients (mean age 55.2 years old, mean post-stroke duration 333.7 days, mean baseline FMA 35.5) completed the study', 'Thirteen recruited stroke patients']","['EEG-based MI-BCI with Visual Feedback and EEG', 'Neurostyle Brain Exercise Therapy', 'standard arm therapy (SAT) control group and BCI with haptic knob (BCI-HK) intervention']",['Upper-extremity Fugl-Meyer Motor Assessment (FMA) scores'],"[{'cui': 'C0015676', 'cui_str': 'Mental Fatigue'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0204097', 'cui_str': 'Stroke Rehabilitation'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C3715149', 'cui_str': '13'}]","[{'cui': 'C0013819', 'cui_str': 'EEG'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C2936181', 'cui_str': 'Visual Feedback'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0452240', 'cui_str': 'Rehabilitation Exercise'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",13.0,0.0392515,"EEG analysis revealed significant positive correlations between relative beta power and BCI performance in the frontal and central brain regions, suggesting that mental fatigue may contribute to poorer BCI performance. ","[{'ForeName': 'Ruyi', 'Initials': 'R', 'LastName': 'Foong', 'Affiliation': ''}, {'ForeName': 'Kai Keng', 'Initials': 'KK', 'LastName': 'Ang', 'Affiliation': ''}, {'ForeName': 'Chai', 'Initials': 'C', 'LastName': 'Quek', 'Affiliation': ''}, {'ForeName': 'Cuntai', 'Initials': 'C', 'LastName': 'Guan', 'Affiliation': ''}, {'ForeName': 'Kok Soon', 'Initials': 'KS', 'LastName': 'Phua', 'Affiliation': ''}, {'ForeName': 'Christopher Wee Keong', 'Initials': 'CWK', 'LastName': 'Kuah', 'Affiliation': ''}, {'ForeName': 'Vishwanath Arun', 'Initials': 'VA', 'LastName': 'Deshmukh', 'Affiliation': ''}, {'ForeName': 'Lester Hon Lum', 'Initials': 'LHL', 'LastName': 'Yam', 'Affiliation': ''}, {'ForeName': 'Deshan Kumar', 'Initials': 'DK', 'LastName': 'Rajeswaran', 'Affiliation': ''}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Tang', 'Affiliation': ''}, {'ForeName': 'Effie', 'Initials': 'E', 'LastName': 'Chew', 'Affiliation': ''}, {'ForeName': 'Karen Sui Geok', 'Initials': 'KSG', 'LastName': 'Chua', 'Affiliation': ''}]",IEEE transactions on bio-medical engineering,['10.1109/TBME.2019.2921198'] 325,32152642,Impact of whey protein isolate and eccentric training on quadriceps mass and strength in patients with anterior cruciate ligament rupture: A randomized controlled trial.,"OBJECTIVE To examine the effects of combining whey protein isolate supplement with preoperative isokinetic eccentric training on quadriceps mass and strength following anterior cruciate ligament rupture. DESIGN Randomized controlled trial. SUBJECTS A total of 37 male subjects with anterior cruciate ligament rupture. METHODS Participants were randomly assigned to an isokinetic eccentric training group (n = 19) or an isokinetic eccentric training + whey protein isolate group (n = 18). Both groups received isokinetic eccentric training for 6 weeks. The isokinetic eccentric training + whey protein isolate group received 22 g whey protein isolate daily. RESULTS After the intervention, the cross-sectional area of the affected quadriceps had increased only in the isokinetic eccentric training + whey protein isolate group (7.6 ± 6.8%; p = 0.012), whereas there was no change in the isokinetic eccentric training group (3.7 ± 4.5%; p = 0.11). Both groups showed increased quadriceps strength; however, there were no further effects for the isokinetic eccentric training + whey protein isolate group. Lysholm and IKDC 2000 knee function scores increased only in the isokinetic eccentric training + whey protein isolate group (p < 0.01). CONCLUSION Although the study showed numerically better outcomes for the combination of whey protein isolate supplement with isokinetic eccentric training compared with isokinetic eccentric training alone, no statistically significant differences were demonstrated between the groups.",2020,"Lysholm and IKDC 2000 knee function scores increased only in the isokinetic eccentric training + whey protein isolate group (p < 0.01). ","['37 male subjects with anterior cruciate ligament rupture', 'anterior cruciate ligament rupture', 'Participants', 'patients with anterior cruciate ligament rupture']","['whey protein isolate and eccentric training', 'combining whey protein isolate supplement with preoperative isokinetic eccentric training', 'isokinetic eccentric training', 'isokinetic eccentric training + whey protein isolate group received 22 g whey protein isolate daily', 'isokinetic eccentric training group (n\u2009=\u200919) or an isokinetic eccentric training + whey protein isolate group']","['Lysholm and IKDC 2000 knee function scores', 'quadriceps mass and strength', 'quadriceps strength']","[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0409312', 'cui_str': 'Anterior Cruciate Ligament Tear'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0078479', 'cui_str': 'Whey Proteins'}, {'cui': 'C0205409', 'cui_str': 'Isolated (qualifier value)'}, {'cui': 'C0439740', 'cui_str': 'Eccentric (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0450404', 'cui_str': '22G (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}]","[{'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}]",37.0,0.0177142,"Lysholm and IKDC 2000 knee function scores increased only in the isokinetic eccentric training + whey protein isolate group (p < 0.01). ","[{'ForeName': 'Xiaoyuan', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': ''}, {'ForeName': 'Hongshi', 'Initials': 'H', 'LastName': 'Huang', 'Affiliation': ''}, {'ForeName': 'Yuanyuan', 'Initials': 'Y', 'LastName': 'Yu', 'Affiliation': ''}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': ''}, {'ForeName': 'Zixuan', 'Initials': 'Z', 'LastName': 'Liang', 'Affiliation': ''}, {'ForeName': 'Cuiqing', 'Initials': 'C', 'LastName': 'Chang', 'Affiliation': ''}]",Journal of rehabilitation medicine,['10.2340/16501977-2664'] 326,30822774,"Randomized, double-blind, placebo-controlled study of F17464, a preferential D 3 antagonist, in the treatment of acute exacerbation of schizophrenia.","F17464, a highly potent preferential D3 antagonist, is a novel compound in development for schizophrenia treatment. This phase II, double-blind, randomized, placebo-controlled, parallel-group study in five European countries evaluated the efficacy and safety of F17464, 20 mg twice daily, versus placebo over 6 weeks in patients with acute exacerbation of schizophrenia. Change from baseline to Day 43 of the Positive and Negative Syndrome Scale (PANSS) total score was the primary outcome. The data from 134 randomized patients (67 per group) were analyzed (efficacy/safety). Using analysis of covariance (ANCOVA) after last observation carried forward (LOCF) imputation (primary analysis), the PANSS total score reduction was statistically significantly greater for F17464 than placebo treated subjects at endpoint (p = 0.014); using ANCOVA with Multiple Imputation (MI) method, the between-group difference was in favor of F17464 but did not reach statistical significance. Differences in PANSS positive and general psychopathology subscale score, Marder positive factor score, PANSS response, and PANSS resolution criteria were also statistically significant in favor of F17464 (p values < 0.05) using the LOCF method, with similar results as for the primary analysis using the MI method. Treatment-related adverse events (AEs) were reported in 49.3% and 46.3% of patients on F17464 and placebo, respectively. The most common AEs in F17464 group: insomnia, agitation, and increased triglycerides; worsening of schizophrenia/drug ineffective was less frequent in F17464. Interestingly, no weight gain, no extrapyramidal disorder except rare akathisia were observed under F17464. This 6-week trial demonstrated therapeutic efficacy of 40 mg/day F17464 in improving symptoms of acute exacerbation of schizophrenia with a favorable safety profile.",2019,"Interestingly, no weight gain, no extrapyramidal disorder except rare akathisia were observed under F17464.","['acute exacerbation of schizophrenia', 'patients with acute exacerbation of schizophrenia']",['placebo'],"['weight gain, no extrapyramidal disorder except rare akathisia', 'insomnia, agitation, and increased triglycerides; worsening of schizophrenia/drug ineffective', 'PANSS positive and general psychopathology subscale score, Marder positive factor score, PANSS response, and PANSS resolution criteria', 'adverse events (AEs', 'PANSS total score reduction', 'therapeutic efficacy', 'Positive and Negative Syndrome Scale (PANSS) total score']","[{'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0043094', 'cui_str': 'Weight Gain'}, {'cui': 'C0015371', 'cui_str': 'Extrapyramidal Disorders'}, {'cui': 'C0522498', 'cui_str': 'Uncommon (qualifier value)'}, {'cui': 'C0392156', 'cui_str': 'Akathisia'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0085631', 'cui_str': 'Feeling agitated (finding)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C0852908', 'cui_str': 'Drug ineffective'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0033927', 'cui_str': 'Psychopathology'}, {'cui': 'C0459443', 'cui_str': 'Subscale score (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0451383', 'cui_str': 'Positive and negative syndrome scale (assessment scale)'}]",134.0,0.307203,"Interestingly, no weight gain, no extrapyramidal disorder except rare akathisia were observed under F17464.","[{'ForeName': 'Istvan', 'Initials': 'I', 'LastName': 'Bitter', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Semmelweis University, Balassa u.6, Budapest, 1083, Hungary.'}, {'ForeName': 'Jeffrey A', 'Initials': 'JA', 'LastName': 'Lieberman', 'Affiliation': 'New York Presbyterian Hospital - Columbia University Medical Center, 1051 Riverside Drive, New York, NY, 10032, USA.'}, {'ForeName': 'Florence', 'Initials': 'F', 'LastName': 'Gaudoux', 'Affiliation': 'Institut de Recherche Pierre Fabre, 3 avenue Hubert Curien, Toulouse, 31000, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Sokoloff', 'Affiliation': 'PSAdvice, Impasse Larosa, Ile-aux-Moines, 56780, France.'}, {'ForeName': 'Mélanie', 'Initials': 'M', 'LastName': 'Groc', 'Affiliation': 'Institut de Recherche Pierre Fabre, 3 avenue Hubert Curien, Toulouse, 31000, France.'}, {'ForeName': 'Rajeev', 'Initials': 'R', 'LastName': 'Chavda', 'Affiliation': ""Galderma, Rue D'Entre-deux-Villes 10, La Tour de Peilz, 1814, Switzerland.""}, {'ForeName': 'Cécile', 'Initials': 'C', 'LastName': 'Delsol', 'Affiliation': 'Institut de Recherche Pierre Fabre, 3 avenue Hubert Curien, Toulouse, 31000, France.'}, {'ForeName': 'Laurence', 'Initials': 'L', 'LastName': 'Barthe', 'Affiliation': 'Institut de Recherche Pierre Fabre, 3 avenue Hubert Curien, Toulouse, 31000, France.'}, {'ForeName': 'Valérie', 'Initials': 'V', 'LastName': 'Brunner', 'Affiliation': 'IRIS Servier, 50 rue Carot, Suresnes Cedex, 92284, France.'}, {'ForeName': 'Carine', 'Initials': 'C', 'LastName': 'Fabre', 'Affiliation': 'Institut de Recherche Pierre Fabre, 3 avenue Hubert Curien, Toulouse, 31000, France.'}, {'ForeName': 'Marine', 'Initials': 'M', 'LastName': 'Fagard', 'Affiliation': 'Institut de Recherche Pierre Fabre, 3 avenue Hubert Curien, Toulouse, 31000, France.'}, {'ForeName': 'Agnès', 'Initials': 'A', 'LastName': 'Montagne', 'Affiliation': 'Institut de Recherche Pierre Fabre, 3 avenue Hubert Curien, Toulouse, 31000, France.'}, {'ForeName': 'Françoise', 'Initials': 'F', 'LastName': 'Tonner', 'Affiliation': 'Institut de Recherche Pierre Fabre, 3 avenue Hubert Curien, Toulouse, 31000, France. francoise.tonner@pierre-fabre.com.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0355-2'] 327,31974590,Does inspiration efficiency influence the stability limits of the trunk in patients with chronic low back pain?,"OBJECTIVE To determine the effects of diaphragm-strengthening training on the stability limits of the trunk and inspiratory function in patients with low back pain. DESIGN A randomized comparative trial including a diaphragm training group that took part in conventional training together with diaphragm strengthening, and a control group that took part in conventional training only. Both groups participated in an 8-week training, 2 times/week. All subjects underwent the same measurement protocol before and after the intervention. PATIENTS The study included 52 subjects with chronic low back pain. METHODS The inspiratory functions (chest excursion, maximal inspiratory pressure, peak inspiratory flow, and volume of inspired air) and stability limits of the trunk with the subject in the sitting position (modified functional and lateral reach test) were assessed. RESULTS Maximal inspiratory pressure and stability limit tests showed a statistically significant improvement only in the diaphragm training group. Statistically significant improvements in chest excursion and peak expiratory flow tests were found in both groups; however, the improvement was more greater in the diaphragm training group. CONCLUSION Conventional exercises together with diaphragm training result in a greater improvement than conventional exercises alone in patients with chronic low back pain.",2020,"Statistically discernible improvements in chest excursion and peak expiratory flow tests were found in both groups; however, the improvement was more meaningful in the diaphragm training group. ","['patients with chronic low back pain', 'patients with low back pain', '52 subjects with chronic low back pain']","['diaphragm-strengthening training', 'diaphragm training', 'conventional training together with diaphragm strengthening']","['inspiratory functions (chest excursion, maximal inspiratory pressure, peak inspiratory flow, and volume of inspired air) and stability limits of the trunk with the subject in the sitting position (modified functional and lateral reach test', 'chest excursion and peak expiratory flow tests', 'Maximal inspiratory pressure and stability limit tests']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain (finding)'}, {'cui': 'C0024031', 'cui_str': 'Low Back Ache'}]","[{'cui': 'C0011980', 'cui_str': 'Respiratory Diaphragm'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}]","[{'cui': 'C0004048', 'cui_str': 'Inhalation'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C4083126', 'cui_str': 'Maximum Inspiratory Pressure'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0439801', 'cui_str': 'Limited (qualifier value)'}, {'cui': 'C0460005', 'cui_str': 'Torso'}, {'cui': 'C0277814', 'cui_str': 'Sitting position (finding)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0205093', 'cui_str': 'Lateral (qualifier value)'}, {'cui': 'C0596012', 'cui_str': 'Does reach (finding)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0231800', 'cui_str': 'Exhalation'}]",52.0,0.014004,"Statistically discernible improvements in chest excursion and peak expiratory flow tests were found in both groups; however, the improvement was more meaningful in the diaphragm training group. ","[{'ForeName': 'Regina', 'Initials': 'R', 'LastName': 'Finta', 'Affiliation': 'Occupational Therapy Division, School of Health and Rehabilitation Sciences, The Ohio State University, , Columbus, USA. spageneuro@gmail.com.'}, {'ForeName': 'Krisztina', 'Initials': 'K', 'LastName': 'Boda', 'Affiliation': ''}, {'ForeName': 'Edit', 'Initials': 'E', 'LastName': 'Nagy', 'Affiliation': ''}, {'ForeName': 'Tamás', 'Initials': 'T', 'LastName': 'Bender', 'Affiliation': ''}]",Journal of rehabilitation medicine,['10.2340/16501977-2645'] 328,30932953,Risk factors for antiretroviral therapy (ART) discontinuation in a large multinational trial of early ART initiators.,"OBJECTIVE We aimed to investigate potential causes of higher risk of treatment interruptions within the multicountry Strategic Timing of AntiRetroviral Treatment (START) trial in 2015. METHODS We defined baseline as the date of starting antiretroviral therapy (ART) and a treatment interruption as discontinuing ART for at least 2 weeks. Participants were stratified by randomization arm and followed from baseline to earliest end date of the initial phase of START, death, date of consent withdrawn or date of first treatment interruption. Cox regression was used to calculate hazard ratios and 95% confidence intervals for factors that may predict treatment interruptions in each arm. RESULTS Of the 3438 participants who started ART, 2286 were in the immediate arm and 1152 in the deferred arm. 12.9% of people in the immediate arm and 10.5% of people in the deferred arm experienced at least one treatment interruption by 3 years after starting ART. In adjusted analyses, age [hazard ratio for 35-50 years: 0.75 (95% confidence interval: 0.59-0.97) and >50 years: 0.53 (0.33-0.80) vs. <35 years], education status [hazard ratio for postgraduate education vs. less than high-school education (0.23 (0.10-0.50))] and region [hazard ratio for United States vs. Europe/Israel (3.16 (2.09-4.77))] were significantly associated with treatment interruptions in the immediate arm. In the deferred arm, age and education status were significantly associated with treatment interruptions. CONCLUSION Within START, we identified younger age and lower educational attainment as potential causes of ART interruption. There is a need to strengthen adherence advice and wider social support in younger people and those of lower education status.",2019,"In adjusted analyses, age [hazard ratio for 35-50 years: 0.75 (95% confidence interval: 0.59-0.97) and >50 years: 0.53 (0.33-0.80) vs. <35 years], education status [hazard ratio for postgraduate education vs. less than high-school education (0.23 (0.10-0.50))] and region [hazard ratio for United States vs. Europe/Israel (3.16 (2.09-4.77))] were significantly associated with treatment interruptions in the immediate arm.","['2015', '3438 participants who started ART']",['antiretroviral therapy (ART) discontinuation'],[],"[{'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0003826', 'cui_str': 'Arts'}]","[{'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}]",[],3438.0,0.235235,"In adjusted analyses, age [hazard ratio for 35-50 years: 0.75 (95% confidence interval: 0.59-0.97) and >50 years: 0.53 (0.33-0.80) vs. <35 years], education status [hazard ratio for postgraduate education vs. less than high-school education (0.23 (0.10-0.50))] and region [hazard ratio for United States vs. Europe/Israel (3.16 (2.09-4.77))] were significantly associated with treatment interruptions in the immediate arm.","[{'ForeName': 'Loveleen', 'Initials': 'L', 'LastName': 'Bansi-Matharu', 'Affiliation': 'Institute for Global Health, UCL, London, UK.'}, {'ForeName': 'Gabriela', 'Initials': 'G', 'LastName': 'Rodriguez Loria', 'Affiliation': 'Fundacion IBIS, Research, Buenos Aires, Argentina.'}, {'ForeName': 'Stephen R', 'Initials': 'SR', 'LastName': 'Cole', 'Affiliation': 'Johann Wolfgang Goethe University Hospital, Frankfurt, Germany.'}, {'ForeName': 'Henry', 'Initials': 'H', 'LastName': 'Mugerwa', 'Affiliation': 'Joint Clinical Research Centre, Kampala, Uganda.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Vecino', 'Affiliation': 'University of North Texas HSC, Fort Worth, Texas, USA.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Lundgren', 'Affiliation': 'CHIP, Department of Infectious Diseases, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Pulik', 'Affiliation': 'Hospital for Infectious Diseases, HIV Out-Patient Clinic, Warsaw, Poland.'}, {'ForeName': 'Colette', 'Initials': 'C', 'LastName': 'Smith', 'Affiliation': 'Institute for Global Health, UCL, London, UK.'}, {'ForeName': 'Andrew N', 'Initials': 'AN', 'LastName': 'Phillips', 'Affiliation': 'Institute for Global Health, UCL, London, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","AIDS (London, England)",['10.1097/QAD.0000000000002210'] 329,32283078,Is There a Difference in Volumetric Change and Effectiveness Comparing Pedicled Buccal Fat Pad and Abdominal Fat When Used as Interpositional Arthroplasty in the Treatment of Temporomandibular Joint Ankylosis?,"PURPOSE There is limited evidence in the literature about fat grafting in the management of temporomandibular joint ankylosis (TMJA). The purpose was to investigate which interpositional fat grafting technique is superior in the operative management of TMJA. The specific aim was to compare the volumetric change and maximal mouth opening (MIO) when pedicled buccal fat or abdominal fat is interposed in patients being treated for TMJA. PATIENTS AND METHODS A randomized controlled trial was conducted on TMJA patients divided into 2 groups: Pedicled buccal fat pad was used for interposition in group A, whereas abdominal fat was used in group B. At the end of 1 year, the volumetric change in fat was analyzed by comparing immediate postoperative and 1-year follow-up magnetic resonance imaging (MRI). MIO and re-ankylosis were recorded. Categorical variables were analyzed by the χ 2 test or Fisher exact test. Continuous variables were compared using the t test and Wilcoxon signed rank test. Linear regression analysis was performed. RESULTS A total of 36 patients (51 joints [15 bilateral and 21 unilateral]) were included, comprising 18 in group A and 18 in group B. The mean preoperative MIO measured 6.8 mm in group A and 4.2 mm in group B. The mean immediate postoperative MRI fat volume was 4.3 cm 3 in group A and 10.8 cm 3 in group B. One-year follow-up MRI showed a fat retention rate of 32.44% in group A and 58.17% in group B. The rate of volumetric shrinkage was 67.5% in group A and 41.9% in group B (P < .001). Analysis of variance showed a statistically significant difference between volumetric shrinkage and both treatment groups (P < .001). MIO improved to 30.6 mm in the pedicled buccal fat pad group (group A) and 41.9 mm in the abdominal fat group (group B) (P < .001). No re-ankylosis occurred in either group at 1-year follow-up. CONCLUSIONS Our study results suggest that the percentage of retention of interposed abdominal fat at 1 year is more than that of pedicled buccal fat pad. Volumetric shrinkage is greater with buccal fat pad, which is a paradox considering the pedicled blood supply. Abdominal fat is better than pedicled buccal fat pad when used for interposition in TMJA treatment.",2020,The rate of volumetric shrinkage was 67.5% in group A and 41.9% in group B (P < .001).,"['36 patients (51 joints [15 bilateral and 21 unilateral', 'patients being treated for TMJA', 'TMJA patients divided into 2 groups']",['Pedicled buccal fat pad was used for interposition'],"['fat retention rate', 'mean preoperative MIO', 'Volumetric Change and Effectiveness Comparing Pedicled Buccal Fat Pad and Abdominal Fat', 'MIO', 'percentage of retention of interposed abdominal fat', 'mean immediate postoperative MRI fat volume', 're-ankylosis', 'volumetric shrinkage', 'volumetric change and maximal mouth opening (MIO', 'Volumetric shrinkage', 'MIO and re-ankylosis', 'volumetric change in fat', 'rate of volumetric shrinkage']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for'}, {'cui': 'C2931375', 'cui_str': 'Ankylosis of temporomandibular joint'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0226900', 'cui_str': 'Buccal fat pad'}]","[{'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0445383', 'cui_str': 'Volumetric'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0226900', 'cui_str': 'Buccal fat pad'}, {'cui': 'C1563742', 'cui_str': 'Fat, Abdominal'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0028580', 'cui_str': 'Nuclear Magnetic Resonance'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0003090', 'cui_str': 'Ankylosis'}, {'cui': 'C0332513', 'cui_str': 'Shrinkage'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0240379', 'cui_str': 'Open mouth'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]",36.0,0.055982,The rate of volumetric shrinkage was 67.5% in group A and 41.9% in group B (P < .001).,"[{'ForeName': 'Ajoy', 'Initials': 'A', 'LastName': 'Roychoudhury', 'Affiliation': 'Professor and Head, Department of Oral & Maxillofacial Surgery, All India Institute of Medical Sciences, New Delhi, India. Electronic address: ajoyroy@hotmail.com.'}, {'ForeName': 'Surendra', 'Initials': 'S', 'LastName': 'Acharya', 'Affiliation': 'Ex-Junior Resident, Department of Oral & Maxillofacial surgery, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Ongkila', 'Initials': 'O', 'LastName': 'Bhutia', 'Affiliation': 'Professor, Department of Oral & Maxillofacial Surgery, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Ashu', 'Initials': 'A', 'LastName': 'Seith Bhalla', 'Affiliation': 'Professor, Department of Radiodiagnosis, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Smita', 'Initials': 'S', 'LastName': 'Manchanda', 'Affiliation': 'Associate Professor, Department of Radiodiagnosis, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Ravindra Mohan', 'Initials': 'RM', 'LastName': 'Pandey', 'Affiliation': 'Professor and Head, Department of Biostatistics, All India Institute of Medical Sciences, New Delhi, India.'}]",Journal of oral and maxillofacial surgery : official journal of the American Association of Oral and Maxillofacial Surgeons,['10.1016/j.joms.2020.03.006'] 330,31263231,Reaching measures and feedback effects in auditory peripersonal space.,"We analyse the effects of exploration feedback on reaching measures of perceived auditory peripersonal space (APS) boundary and the auditory distance perception (ADP) of sound sources located within it. We conducted an experiment in which the participants had to estimate if a sound source was (or not) reachable and to estimate its distance (40 to 150 cm in 5-cm steps) by reaching to a small loudspeaker. The stimulus consisted of a train of three bursts of Gaussian broadband noise. Participants were randomly assigned to two groups: Experimental (EG) and Control (CG). There were three phases in the following order: Pretest-Test-Posttest. For all phases, the listeners performed the same task except for the EG-Test phase where the participants reach in order to touch the sound source. We applied models to characterise the participants' responses and provide evidence that feedback significantly reduces the response bias of both the perceived boundary of the APS and the ADP of sound sources located within reach. In the CG, the repetition of the task did not affect APS and ADP accuracy, but it improved the performance consistency: the reachable uncertainty zone in APS was reduced and there was a tendency to decrease variability in ADP.",2019,"In the CG, the repetition of the task did not affect APS and ADP accuracy, but it improved the performance consistency: the reachable uncertainty zone in APS was reduced and there was a tendency to decrease variability in ADP.",['participants had to estimate if a sound source was (or not) reachable and to estimate its distance (40 to 150\u2009cm in 5-cm steps) by reaching to a small loudspeaker'],['exploration feedback'],"['APS and ADP accuracy', 'auditory peripersonal space (APS) boundary\xa0and the auditory distance perception (ADP']","[{'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C1293120', 'cui_str': 'Sounding'}, {'cui': 'C4521696', 'cui_str': 'Source (property)'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C3879138', 'cui_str': 'Loudspeaker (physical object)'}]","[{'cui': 'C1280903', 'cui_str': 'Exploration procedure'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}]","[{'cui': 'C0085409', 'cui_str': 'Polyendocrinopathies, Autoimmune'}, {'cui': 'C0001459', 'cui_str': ""Adenosine 5'-Pyrophosphate""}, {'cui': 'C0439825', 'cui_str': 'Auditory (qualifier value)'}, {'cui': 'C0031207', 'cui_str': 'Peripersonal Space'}, {'cui': 'C0012752', 'cui_str': 'Distance Perception'}]",,0.0218906,"In the CG, the repetition of the task did not affect APS and ADP accuracy, but it improved the performance consistency: the reachable uncertainty zone in APS was reduced and there was a tendency to decrease variability in ADP.","[{'ForeName': 'Mercedes X', 'Initials': 'MX', 'LastName': 'Hüg', 'Affiliation': 'Centro de Investigación y Transferencia en Acústica (CINTRA), Universidad Tecnológica Nacional - Facultad Regional Córdoba, CONICET, 5000, Córdoba, Argentina. mercehug@unc.edu.ar.'}, {'ForeName': 'Ramiro O', 'Initials': 'RO', 'LastName': 'Vergara', 'Affiliation': 'Consejo Nacional de Investigaciones Científicas y Tecnológicas (CONICET), Buenos Aires, Argentina.'}, {'ForeName': 'Fabián C', 'Initials': 'FC', 'LastName': 'Tommasini', 'Affiliation': 'Centro de Investigación y Transferencia en Acústica (CINTRA), Universidad Tecnológica Nacional - Facultad Regional Córdoba, CONICET, 5000, Córdoba, Argentina.'}, {'ForeName': 'Pablo E', 'Initials': 'PE', 'LastName': 'Etchemendy', 'Affiliation': 'Consejo Nacional de Investigaciones Científicas y Tecnológicas (CONICET), Buenos Aires, Argentina.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Bermejo', 'Affiliation': 'Centro de Investigación y Transferencia en Acústica (CINTRA), Universidad Tecnológica Nacional - Facultad Regional Córdoba, CONICET, 5000, Córdoba, Argentina.'}, {'ForeName': 'Laura G', 'Initials': 'LG', 'LastName': 'Fernandez', 'Affiliation': 'Centro de Investigación y Transferencia en Acústica (CINTRA), Universidad Tecnológica Nacional - Facultad Regional Córdoba, CONICET, 5000, Córdoba, Argentina.'}]",Scientific reports,['10.1038/s41598-019-45755-2'] 331,30760846,A randomised controlled trial of nasal decongestant to treat obstructive sleep apnoea in people with cervical spinal cord injury.,"STUDY DESIGN Prospective, double-blind, randomised, placebo-controlled, cross-over trial of nasal decongestion in tetraplegia. OBJECTIVES Tetraplegia is complicated by severe, predominantly obstructive, sleep apnoea. First-line therapy for obstructive sleep apnoea is nasal continuous positive airway pressure, but this is poorly tolerated. High nasal resistance associated with unopposed parasympathetic activation of the upper airway contributes to poor adherence. This preliminary study tested whether reducing nasal decongestion improved sleep. SETTING Participants' homes in Melbourne and Sydney, Australia. METHODS Two sleep studies were performed in participants' homes separated by 1 week. Participants were given a nasal spray (0.5 mL of 5% phenylephrine or placebo) in random order and posterior nasal resistance measured immediately. Outcomes included sleep apnoea severity, perceived nasal congestion, sleep quality and oxygenation during sleep. RESULTS Twelve middle-aged (average (SD) 52 (12) years) overweight (body mass index 25.3 (6.7) kg/m 2 ) men (C4-6, AIS A and B) participated. Nasal resistance was reduced following administration of phenylephrine (p = 0.02; mean between treatment group difference -5.20: 95% confidence interval -9.09, -1.32 cmH 2 O/L/s). No differences were observed in the apnoea hypopnoea index (p = 0.15; -6.37: -33.3, 20.6 events/h), total sleep time (p = 0.49; -1.33: -51.8, 49.1 min), REM sleep% (p = 0.50; 2.37: -5.6, 10.3), arousal index (p = 0.76; 1.15: -17.45, 19.75), 4% oxygen desaturation index (p = 0.88; 0.63: -23.5, 24.7 events/h), or the percentage of mouth breathing events (p = 0.4; -8.07: -29.2, 13.0) between treatments. The apnoea hypopnoea index did differ between groups, however, all except one participant had proportionally more hypopnoeas than apnoeas during sleep after decongestion. CONCLUSIONS These preliminary data found that phenylephrine acutely reduced nasal resistance but did not significantly change sleep-disordered breathing severity.",2019,Nasal resistance was reduced following administration of phenylephrine (p = 0.02;,"['people with cervical spinal cord injury', ""Participants' homes in Melbourne and Sydney, Australia"", 'Twelve middle-aged (average (SD) 52 (12) years', 'overweight (body mass index 25.3 (6.7)\u2009kg/m 2 ) men ']","['nasal decongestant', 'placebo', 'phenylephrine', 'nasal spray (0.5\u2009mL of 5% phenylephrine or placebo']","['sleep apnoea severity, perceived nasal congestion, sleep quality and oxygenation during sleep', 'percentage of mouth breathing events', 'apnoea hypopnoea index', 'oxygen desaturation index ', 'obstructive sleep apnoea', 'Nasal resistance', 'change sleep-disordered breathing severity', 'nasal resistance', 'arousal index', 'total sleep time']","[{'cui': 'C0840414', 'cui_str': 'Cervical spinal cord injury'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0205847', 'cui_str': 'Middle Aged'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C0042398', 'cui_str': 'Nasal Decongestants'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0031469', 'cui_str': 'Phenylephrine'}, {'cui': 'C0461725', 'cui_str': 'Nasal Spray'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}]","[{'cui': 'C0037315', 'cui_str': 'Sleep Hypopnea'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0027424', 'cui_str': 'Nasal congestion (finding)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0587116', 'cui_str': 'During sleep (qualifier value)'}, {'cui': 'C0026635', 'cui_str': 'Mouth Breathing'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C2111846', 'cui_str': 'Apnea-hypopnea index'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0520679', 'cui_str': 'Syndrome, Sleep Apnea, Obstructive'}, {'cui': 'C0429208', 'cui_str': 'Nasal resistance (observable entity)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0851578', 'cui_str': 'Sleep Disorders'}, {'cui': 'C0035203', 'cui_str': 'Breathing'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",,0.138264,Nasal resistance was reduced following administration of phenylephrine (p = 0.02;,"[{'ForeName': 'Nirupama S', 'Initials': 'NS', 'LastName': 'Wijesuriya', 'Affiliation': 'Neuroscience Research Australia (NeuRA), Randwick, NSW, Australia.'}, {'ForeName': 'Danny J', 'Initials': 'DJ', 'LastName': 'Eckert', 'Affiliation': 'Neuroscience Research Australia (NeuRA), Randwick, NSW, Australia.'}, {'ForeName': 'Amy S', 'Initials': 'AS', 'LastName': 'Jordan', 'Affiliation': 'Institute of Breathing and Sleep (IBAS), Melbourne, VIC, Australia.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Schembri', 'Affiliation': 'Institute of Breathing and Sleep (IBAS), Melbourne, VIC, Australia.'}, {'ForeName': 'Chaminda', 'Initials': 'C', 'LastName': 'Lewis', 'Affiliation': 'Neuroscience Research Australia (NeuRA), Randwick, NSW, Australia.'}, {'ForeName': 'Hailey', 'Initials': 'H', 'LastName': 'Meaklim', 'Affiliation': 'Institute of Breathing and Sleep (IBAS), Melbourne, VIC, Australia.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Booker', 'Affiliation': 'Institute of Breathing and Sleep (IBAS), Melbourne, VIC, Australia.'}, {'ForeName': 'Doug', 'Initials': 'D', 'LastName': 'Brown', 'Affiliation': 'Spinal Research Institute, Heidelberg, VIC, Australia.'}, {'ForeName': 'Marnie', 'Initials': 'M', 'LastName': 'Graco', 'Affiliation': 'Institute of Breathing and Sleep (IBAS), Melbourne, VIC, Australia.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Berlowitz', 'Affiliation': 'Institute of Breathing and Sleep (IBAS), Melbourne, VIC, Australia. david.berlowitz@austin.org.au.'}]",Spinal cord,['10.1038/s41393-019-0256-6'] 332,32111373,"Impact of intraoperative noise measurement on the surgeon stress and patient outcomes. A prospective, controlled, single-center clinical trial with 664 patients.","BACKGROUND The impact of sound-activated noise meters to decrease the noise level in the operating room is not clear. The aim of this study was to determine whether a sound-activated, visual noise meter would decrease noise levels, decrease postoperative morbidity, and improve surgeons' feelings of well-being. METHODS This prospective, single-center study proceeded in 2 phases. First, sound levels were compared during a 6-month period with noise measurement only and without a visual feedback function. Second, we conducted a subsequent 6-month phase with noise meters providing direct feedback. Surgeon disturbance during the operation was assessed by a questionnaire after each procedure. RESULTS Of the 664 procedures included in this analysis, 447 (67.3%) were in phase 1 and 217 (32.7%) in phase 2. The noise levels in the operating room were decreased by 3.8 dB(A) from 54.6 ± 4.5 dB(A) in phase 1 to 50.8 ± 2.8 dB(A) in phase 2 after intervention with the feedback device (P < .001). During the procedures, there was an increase of 0.7 dB(A) (P < .001), with mean noise levels of 53.5 dB(A) at the beginning of the procedures and 54.2 dB(A) at the end. There was a correlation between the disturbance of the surgeon and the noise level (P < .001). CONCLUSION The application of a visual noise warning device in an operating room decreased both the noise levels and surgeon stress and may offer sustained decreases in ambient and peak sound levels, potentially leading to improved quality outcomes in visceral surgery.",2020,"(P < .001), with mean noise levels of 53.5 dB(A) at the beginning of the procedures and 54.2 dB(A) at the end.",['664 patients'],"['sound-activated, visual noise meter', 'intraoperative noise measurement', 'noise meters providing direct feedback', 'visual noise warning device']","['0.7 dB(A', ""postoperative morbidity, and improve surgeons' feelings of well-being"", 'Surgeon disturbance', 'noise levels', 'disturbance of the surgeon and the noise level']","[{'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1293120', 'cui_str': 'Sounding'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C0475209', 'cui_str': 'm'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0220819', 'cui_str': 'devices'}]","[{'cui': 'C4517474', 'cui_str': '0.7 (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0582175', 'cui_str': 'Surgeon (occupation)'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",,0.0203565,"(P < .001), with mean noise levels of 53.5 dB(A) at the beginning of the procedures and 54.2 dB(A) at the end.","[{'ForeName': 'Kristjan', 'Initials': 'K', 'LastName': 'Ukegjini', 'Affiliation': 'Department of General, Visceral, Endocrine, and Transplant Surgery, Kantonsspital St. Gallen, Switzerland. Electronic address: kristjan.ukegjini@kssg.ch.'}, {'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Kastiunig', 'Affiliation': 'Department of General, Visceral, Endocrine, and Transplant Surgery, Kantonsspital St. Gallen, Switzerland.'}, {'ForeName': 'Bernhard', 'Initials': 'B', 'LastName': 'Widmann', 'Affiliation': 'Department of General, Visceral, Endocrine, and Transplant Surgery, Kantonsspital St. Gallen, Switzerland; Department of Surgery, Paracelsus Medical University, Salzburg, Austria.'}, {'ForeName': 'Rene', 'Initials': 'R', 'LastName': 'Warschkow', 'Affiliation': 'Department of General, Visceral, Endocrine, and Transplant Surgery, Kantonsspital St. Gallen, Switzerland.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Steffen', 'Affiliation': 'Department of General, Visceral, Endocrine, and Transplant Surgery, Kantonsspital St. Gallen, Switzerland.'}]",Surgery,['10.1016/j.surg.2019.12.010'] 333,32115879,Nasal glucagon as a viable alternative for treating insulin-induced hypoglycaemia in Japanese patients with type 1 or type 2 diabetes: A phase 3 randomized crossover study.,"AIM To compare nasal glucagon (NG) with intramuscular glucagon (IMG) for the treatment of insulin-induced hypoglycaemia in Japanese patients with type 1 (T1DM) or type 2 diabetes mellitus (T2DM). MATERIALS AND METHODS This phase 3, randomized, open-label, two-treatment, two-period crossover non-inferiority study enrolled Japanese adults with T1DM or T2DM on insulin therapy, with glycated haemoglobin levels ≤86 mmol/mol (≤10%). After ≥8 hours of fasting, hypoglycaemia was induced with human regular insulin (intravenous infusion). Patients received NG 3 mg or IMG 1 mg approximately 5 minutes after insulin termination. The primary endpoint was the proportion of patients achieving treatment success [plasma glucose (PG) increase to ≥3.9 mmol/L (≥70 mg/dL) or ≥1.1 mmol/L (≥20 mg/dL) increase from the PG nadir within 30 minutes of receiving glucagon]. Non-inferiority was declared if the upper limit of the two-sided 95% confidence interval (CI) of the mean difference in the percentage of patients achieving treatment success (IMG minus NG) was <10%. RESULTS Seventy-five patients with T1DM (n = 34) or T2DM (n = 41) were enrolled; 72 patients (50 men, 22 women) received ≥1 study drug dose (T1DM, n = 33; T2DM, n = 39). Sixty-eight patients completed the study and were evaluable. All NG- and IMG-treated patients achieved treatment success (treatment arm difference: 0%; upper limit of two-sided 95% CI 1.47%); NG met prespecified conditions defining non-inferiority versus IMG. Glucagon was rapidly absorbed after both nasal and intramuscular administration; PG profiles were similar between administration routes during the first 60 minutes post dose. Study drug-related treatment-emergent adverse events affecting >2 patients were rhinalgia, increased blood pressure, nausea, ear pain and vomiting in the NG group, and nausea and vomiting in the IMG group. CONCLUSION Nasal glucagon was non-inferior to IMG for successful treatment of insulin-induced hypoglycaemia in Japanese patients with T1DM/T2DM, supporting use of NG as a rescue treatment for severe hypoglycaemia.",2020,,['Japanese Patients with Type 1 and Type 2 Diabetes'],['Nasal Glucagon'],[],"[{'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}]","[{'cui': 'C4520890', 'cui_str': 'Nasal'}, {'cui': 'C0876232', 'cui_str': 'glucagon recombinant'}]",[],,0.0960908,,"[{'ForeName': 'Munehide', 'Initials': 'M', 'LastName': 'Matsuhisa', 'Affiliation': 'Diabetes Therapeutics and Research Centre, Institute of Advanced Medical Sciences, Tokushima University, Tokushima, Japan.'}, {'ForeName': 'Yasushi', 'Initials': 'Y', 'LastName': 'Takita', 'Affiliation': 'Medicine Development Unit-Japan and Medical Affairs, Eli Lilly Japan K.K., Kobe, Japan.'}, {'ForeName': 'Risa', 'Initials': 'R', 'LastName': 'Nasu', 'Affiliation': 'Medicine Development Unit-Japan and Medical Affairs, Eli Lilly Japan K.K., Kobe, Japan.'}, {'ForeName': 'Yukiko', 'Initials': 'Y', 'LastName': 'Nagai', 'Affiliation': 'Medicine Development Unit-Japan and Medical Affairs, Eli Lilly Japan K.K., Kobe, Japan.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Ohwaki', 'Affiliation': 'Medicine Development Unit-Japan and Medical Affairs, Eli Lilly Japan K.K., Kobe, Japan.'}, {'ForeName': 'Hirotaka', 'Initials': 'H', 'LastName': 'Nagashima', 'Affiliation': 'Shinjuku Research Park Clinic, Tokyo, Japan.'}]","Diabetes, obesity & metabolism",['10.1111/dom.14019'] 334,32273696,Effect of Panax Ginseng (G115) Capsules versus Placebo on Acute Exacerbations in Patients with Moderate to Very Severe COPD: A Randomized Controlled Trial.,"Purpose Herbal medicines are commonly used by people with chronic obstructive pulmonary disease (COPD) but high quality randomized controlled trials are limited. This study evaluated the therapeutic value of ginseng capsules in reducing acute exacerbations and improving the quality of life in people with COPD. Patients and Methods This randomized, double-blind and placebo-controlled trial assessed ginseng's effects on 200 patients with moderate to very severe COPD. Ginseng capsules (200 mg, twice per day) were compared to placebo over 24 weeks. Patients were followed up for a further 24 weeks after the treatment period. The primary outcome measure was acute COPD exacerbation rate over 12 months. Secondary outcome measures were health-related quality of life, including the St George's Respiratory Questionnaire (SGRQ), COPD Assessment Test (CAT) and the Short Form 36 Health Survey (SF-36). We also assessed lung function, walking distance and use of relief medication. Results Baseline characteristics were balanced between groups. The rate of COPD exacerbations was not statistically significant between groups after 1 year (62 participants in the ginseng group and 63 in the placebo group). Secondary outcome measures showed improvements after ginseng and placebo but results were not clinically significant. The incidence of adverse events in the two groups was similar and events were unrelated to the intervention. Conclusion Compared with placebo, ginseng did not reduce the rate of acute COPD exacerbations over 12 months. It was safe and well tolerated by people with moderate to very severe COPD.",2020,The rate of COPD exacerbations was not statistically significant between groups after 1 year (62 participants in the ginseng group and 63 in the placebo group).,"['Patients with Moderate to Very Severe COPD', 'people with chronic obstructive pulmonary disease (COPD', 'people with COPD', '200 patients with moderate to very severe COPD']","['placebo', 'ginseng capsules', 'placebo, ginseng', 'Panax Ginseng (G115) Capsules versus Placebo', 'Ginseng capsules', 'Herbal medicines', 'ginseng and placebo']","['acute COPD exacerbation rate', 'rate of COPD exacerbations', 'incidence of adverse events', 'lung function, walking distance and use of relief medication', 'Acute Exacerbations', 'rate of acute COPD exacerbations', ""health-related quality of life, including the St George's Respiratory Questionnaire (SGRQ), COPD Assessment Test (CAT) and the Short Form 36 Health Survey (SF-36"", 'safe and well tolerated', 'acute exacerbations', 'quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C3641272', 'cui_str': 'Very severe'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C4319558', 'cui_str': '200'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0086767', 'cui_str': 'Ginseng'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0025125', 'cui_str': 'Herbs, Medicinal'}]","[{'cui': 'C0439588', 'cui_str': 'Acute-on-chronic'}, {'cui': 'C0600260', 'cui_str': 'Obstructive airways disorder'}, {'cui': 'C3508933', 'cui_str': 'Chronic obstructive pulmonary disease exacerbation'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0429886', 'cui_str': 'Walking distance'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0564405', 'cui_str': 'Feeling relief'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C4284282', 'cui_str': 'COPD assessment test'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}]",200.0,0.750482,The rate of COPD exacerbations was not statistically significant between groups after 1 year (62 participants in the ginseng group and 63 in the placebo group).,"[{'ForeName': 'Yuanbin', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': ""The Second Clinical College of Guangzhou University of Chinese Medicine, Guangdong Provincial Hospital of Chinese Medicine and Guangdong Provincial Academy of Chinese Medical Sciences, Guangzhou, People's Republic of China.""}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Lin', 'Affiliation': ""The Second Clinical College of Guangzhou University of Chinese Medicine, Guangdong Provincial Hospital of Chinese Medicine and Guangdong Provincial Academy of Chinese Medical Sciences, Guangzhou, People's Republic of China.""}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Wu', 'Affiliation': ""The Second Clinical College of Guangzhou University of Chinese Medicine, Guangdong Provincial Hospital of Chinese Medicine and Guangdong Provincial Academy of Chinese Medical Sciences, Guangzhou, People's Republic of China.""}, {'ForeName': 'Yinji', 'Initials': 'Y', 'LastName': 'Xu', 'Affiliation': ""The Second Clinical College of Guangzhou University of Chinese Medicine, Guangdong Provincial Hospital of Chinese Medicine and Guangdong Provincial Academy of Chinese Medical Sciences, Guangzhou, People's Republic of China.""}, {'ForeName': 'Johannah L', 'Initials': 'JL', 'LastName': 'Shergis', 'Affiliation': 'School of Health and Biomedical Sciences, RMIT University, Bundoora, Victoria, Australia.'}, {'ForeName': 'Anthony L', 'Initials': 'AL', 'LastName': 'Zhang', 'Affiliation': 'School of Health and Biomedical Sciences, RMIT University, Bundoora, Victoria, Australia.'}, {'ForeName': 'Zehuai', 'Initials': 'Z', 'LastName': 'Wen', 'Affiliation': ""The Second Clinical College of Guangzhou University of Chinese Medicine, Guangdong Provincial Hospital of Chinese Medicine and Guangdong Provincial Academy of Chinese Medical Sciences, Guangzhou, People's Republic of China.""}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Worsnop', 'Affiliation': 'Institute of Breathing and Sleep, Austin Health, Heidelberg, Victoria, Australia.'}, {'ForeName': 'Cliff', 'Initials': 'C', 'LastName': 'Da Costa', 'Affiliation': 'School of Science, RMIT University, Bundoora, Victoria, Australia.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Thien', 'Affiliation': 'Department of Respiratory Medicine, Eastern Health, Victoria, Australia, and Faculty of Medicine, Nursing and Health Sciences, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Charlie C', 'Initials': 'CC', 'LastName': 'Xue', 'Affiliation': ""The Second Clinical College of Guangzhou University of Chinese Medicine, Guangdong Provincial Hospital of Chinese Medicine and Guangdong Provincial Academy of Chinese Medical Sciences, Guangzhou, People's Republic of China.""}]",International journal of chronic obstructive pulmonary disease,['10.2147/COPD.S236425'] 335,32147225,"Cardiopulmonary dysfunction in adults with a small, unrepaired ventricular septal defect: A long-term follow-up.","BACKGROUND There are increasing reports of cardiac and exercise dysfunction in adults with small, unrepaired ventricular septal defects (VSDs). The primary aim of this study was to evaluate pulmonary function in adults with unrepaired VSDs, and secondly to assess the effects of 900 μg salbutamol on lung function and exercise capacity. METHODS Young adult patients with small, unrepaired VSDs and healthy age- and gender-matched controls were included in a double-blinded, randomised, cross-over study. Participants underwent static and dynamic spirometry, impulse oscillometry, multiple breath washout, diffusion capacity for carbon monoxide, and ergometer bicycle cardiopulmonary exercise test. RESULTS We included 30 patients with VSD (age 27 ± 6 years) and 30 controls (age 27 ± 6 years). Patients tended to have lower FEV 1 , 104 ± 11% of predicted, compared with healthy controls, 110 ± 14% (p = 0.069). Furthermore, the patient group had lower peak expiratory flow (PEF), 108 ± 20% predicted, compared with the control group, 118 ± 17% (p = 0.039), and showed tendencies towards lower forced vital capacity and increased airway resistance compared with controls. During exercise, the patients had lower oxygen uptake, 35 ± 8 ml/min/kg (vs 47 ± 7 ml/min/kg, p < 0.001), minute ventilation, 1.5 ± 0.5 l/min/kg (vs 2.1 ± 0.3 l/min/kg, p < 0.001) and breath rate, 48 ± 11 breaths/min (vs 55 ± 8 breaths/min, p = 0.008), than controls. CONCLUSION At rest, young adults with unrepaired VSDs are no different in pulmonary function from controls. However, when the cardiorespiratory system is stressed, VSD patients demonstrate significantly impaired minute ventilation and peak oxygen uptake, which may be early signs of parenchymal dysfunction and restrictive airway disease. These abnormalities were unaffected by the inhalation of salbutamol.",2020,"Patients tended to have lower FEV 1 , 104 ± 11% of predicted, compared with healthy controls, 110 ± 14% (p = 0.069).","['Young adult patients with small, unrepaired VSDs and healthy age- and gender-matched controls', 'adults with small, unrepaired ventricular septal defects (VSDs', '30 patients with VSD (age 27\u202f±\u202f6\u202fyears) and 30 controls (age 27\u202f±\u202f6\u202fyears', 'adults with unrepaired VSDs', 'adults with a small, unrepaired ventricular septal defect']","['static and dynamic spirometry, impulse oscillometry, multiple breath washout, diffusion capacity for carbon monoxide, and ergometer bicycle cardiopulmonary exercise test']","['minute ventilation and peak oxygen uptake', 'lower peak expiratory flow (PEF', 'pulmonary function', 'Cardiopulmonary dysfunction', 'airway resistance', 'breath rate']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0018818', 'cui_str': 'Intraventricular Septal Defects'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0441463', 'cui_str': 'Static (qualifier value)'}, {'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C0037981', 'cui_str': 'Spirometry'}, {'cui': 'C0443235', 'cui_str': 'Impulse (qualifier value)'}, {'cui': 'C0029375', 'cui_str': 'Oscillometry'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0225386', 'cui_str': 'Breath (substance)'}, {'cui': 'C0012222', 'cui_str': 'Diffusion'}, {'cui': 'C0007018', 'cui_str': 'Carbon Monoxide'}, {'cui': 'C0005375', 'cui_str': 'Bicycle, device (physical object)'}, {'cui': 'C2959886', 'cui_str': 'Cardiopulmonary Exercise Test'}]","[{'cui': 'C1301655', 'cui_str': 'Minute ventilation'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake (observable entity)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0231800', 'cui_str': 'Exhalation'}, {'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C0031847', 'cui_str': 'pathophysiology'}, {'cui': 'C0001884', 'cui_str': 'Airway Resistance'}, {'cui': 'C0225386', 'cui_str': 'Breath (substance)'}]",30.0,0.0862747,"Patients tended to have lower FEV 1 , 104 ± 11% of predicted, compared with healthy controls, 110 ± 14% (p = 0.069).","[{'ForeName': 'Filip', 'Initials': 'F', 'LastName': 'Eckerström', 'Affiliation': 'Dept. of Cardiothoracic & Vascular Surgery, Aarhus University Hospital, Denmark; Dept. of Clinical Medicine, Aarhus University Hospital, Denmark. Electronic address: filip.eckerstrom@clin.au.dk.'}, {'ForeName': 'Christian Emil', 'Initials': 'CE', 'LastName': 'Rex', 'Affiliation': 'Dept. of Cardiothoracic & Vascular Surgery, Aarhus University Hospital, Denmark; Dept. of Clinical Medicine, Aarhus University Hospital, Denmark.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Maagaard', 'Affiliation': 'Dept. of Cardiothoracic & Vascular Surgery, Aarhus University Hospital, Denmark; Dept. of Clinical Medicine, Aarhus University Hospital, Denmark.'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Heiberg', 'Affiliation': 'Dept. of Cardiothoracic & Vascular Surgery, Aarhus University Hospital, Denmark; Dept. of Clinical Medicine, Aarhus University Hospital, Denmark.'}, {'ForeName': 'Sune', 'Initials': 'S', 'LastName': 'Rubak', 'Affiliation': 'Dept. of Clinical Medicine, Aarhus University Hospital, Denmark; Dept. of Child and Adolescent Health, Danish Center of Pediatric Pulmonology and Allergology, Aarhus University Hospital, Denmark.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Redington', 'Affiliation': ""The Heart Institute, Cincinnati Children's, Cincinnati, OH, USA.""}, {'ForeName': 'Vibeke Elisabeth', 'Initials': 'VE', 'LastName': 'Hjortdal', 'Affiliation': 'Dept. of Cardiothoracic & Vascular Surgery, Aarhus University Hospital, Denmark; Dept. of Clinical Medicine, Aarhus University Hospital, Denmark.'}]",International journal of cardiology,['10.1016/j.ijcard.2020.02.069'] 336,30814670,Probiotics [LGG-BB12 or RC14-GR1] versus placebo as prophylaxis for urinary tract infection in persons with spinal cord injury [ProSCIUTTU]: a randomised controlled trial.,"STUDY DESIGN Randomised double-blind factorial-design placebo-controlled trial. OBJECTIVE Urinary tract infections (UTIs) are common in people with spinal cord injury (SCI). UTIs are increasingly difficult to treat due to emergence of multi-resistant organisms. Probiotics are efficacious in preventing UTIs in post-menopausal women. We aimed to determine whether probiotic therapy with Lactobacillus reuteri RC-14+Lactobacillus GR-1 (RC14-GR1) and/or Lactobacillus rhamnosus GG+Bifidobacterium BB-12 (LGG-BB12) are effective in preventing UTI in people with SCI. SETTING Spinal units in New South Wales, Australia with their rural affiliations. METHODS We recruited 207 eligible participants with SCI and stable neurogenic bladder management. They were randomised to one of four arms: RC14-GR1+LGG-BB12, RC14-GR1+placebo, LGG-BB12+ placebo or double placebos for 6 months. Randomisation was stratified by bladder management type and inpatient or outpatient status. The primary outcome was time to occurrence of symptomatic UTI. RESULTS Analysis was based on intention to treat. Participants randomised to RC14-GR1 had a similar risk of UTI as those not on RC14-GR1 (HR 0.67; 95% CI: 0.39-1.18; P = 0.17) after allowing for pre-specified covariates. Participants randomised to LGG-BB12 also had a similar risk of UTI as those not on LGG-BB12 (HR 1.29; 95% CI: 0.74-2.25; P = 0.37). Multivariable post hoc survival analysis for RC14-GR1 only vs. the other three groups showed a potential protective effect (HR 0.46; 95% CI: 0.21-0.99; P = 0.03), but this result would need to be confirmed before clinical application. CONCLUSION In this RCT, there was no effect of RC14-GR1 or LGG-BB12 in preventing UTI in people with SCI.",2019,Participants randomised to RC14-GR1 had a similar risk of UTI as those not on RC14-GR1 (HR 0.67; 95% CI: 0.39-1.18; P = 0.17) after allowing for pre-specified covariates.,"['post-menopausal women', 'people with SCI', 'persons with spinal cord injury [ProSCIUTTU', 'people with spinal cord injury (SCI', '207 eligible participants with SCI and stable neurogenic bladder management', 'Spinal units in New South Wales, Australia with their rural affiliations']","['Probiotics', 'placebo', 'Probiotics [LGG-BB12 or RC14-GR1', 'probiotic therapy with Lactobacillus reuteri RC-14+Lactobacillus GR-1 (RC14-GR1) and/or Lactobacillus rhamnosus GG+Bifidobacterium BB-12 (LGG-BB12', 'RC14-GR1', 'RC14-GR1+LGG-BB12, RC14-GR1+placebo, LGG-BB12+ placebo or double placebos']","['potential protective effect', 'RC14-GR1 or LGG-BB12', 'time to occurrence of symptomatic UTI']","[{'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0025320', 'cui_str': 'Change of Life, Female'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0037929', 'cui_str': 'Spinal Cord Trauma'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0005697', 'cui_str': 'Neurogenic Bladder'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0004340', 'cui_str': 'Australia'}]","[{'cui': 'C0525033', 'cui_str': 'Probiotics'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2242626', 'cui_str': 'Probiotic therapy (regime/therapy)'}, {'cui': 'C0317625', 'cui_str': 'Lactobacillus reuteri'}, {'cui': 'C0317597', 'cui_str': 'Lactobacillus casei rhamnosus'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease (disorder)'}]",207.0,0.746012,Participants randomised to RC14-GR1 had a similar risk of UTI as those not on RC14-GR1 (HR 0.67; 95% CI: 0.39-1.18; P = 0.17) after allowing for pre-specified covariates.,"[{'ForeName': 'Swee-Ling', 'Initials': 'SL', 'LastName': 'Toh', 'Affiliation': 'Department of Spinal and Rehabilitation Medicine, Prince of Wales Hospital, Sydney, Australia. SweeLing.Toh@health.nsw.gov.au.'}, {'ForeName': 'Bonsan Bonne', 'Initials': 'BB', 'LastName': 'Lee', 'Affiliation': 'Department of Spinal and Rehabilitation Medicine, Prince of Wales Hospital, Sydney, Australia.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Ryan', 'Affiliation': 'Neuroscience Research Australia [NeuRA] and the University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Judy M', 'Initials': 'JM', 'LastName': 'Simpson', 'Affiliation': 'School of Public Health, University of Sydney, Sydney, Australia.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Clezy', 'Affiliation': 'Department of Infectious Diseases, Prince of Wales Hospital, Sydney, Australia.'}, {'ForeName': 'Laetitia', 'Initials': 'L', 'LastName': 'Bossa', 'Affiliation': 'Neuroscience Research Australia [NeuRA] and the University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Scott Alan', 'Initials': 'SA', 'LastName': 'Rice', 'Affiliation': 'Centre for Marine Bio-Innovation, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Obaydullah', 'Initials': 'O', 'LastName': 'Marial', 'Affiliation': 'Neuroscience Research Australia [NeuRA] and the University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Gerard Hogan', 'Initials': 'GH', 'LastName': 'Weber', 'Affiliation': 'Royal Rehabilitation Centre Sydney, Sydney, Australia.'}, {'ForeName': 'Jasbeer', 'Initials': 'J', 'LastName': 'Kaur', 'Affiliation': 'Royal North Shore Hospital, Sydney, Australia.'}, {'ForeName': 'Claire Louise', 'Initials': 'CL', 'LastName': 'Boswell-Ruys', 'Affiliation': 'Department of Spinal and Rehabilitation Medicine, Prince of Wales Hospital, Sydney, Australia.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Goodall', 'Affiliation': 'Centre for Health Economics Research and Evaluation [CHERE], University of Technology Sydney, Sydney, Australia.'}, {'ForeName': 'James Walter', 'Initials': 'JW', 'LastName': 'Middleton', 'Affiliation': 'John Walsh Centre for Rehabilitation Research, Kolling Institute, Northern Sydney Local Health District, St Leonards, NSW, 2065, Australia.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Tuderhope', 'Affiliation': 'Royal North Shore Hospital, Sydney, Australia.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Kotsiou', 'Affiliation': 'Royal North Shore Hospital, Sydney, Australia.'}]",Spinal cord,['10.1038/s41393-019-0251-y'] 337,32053276,Anti-platelet antibodies in childhood immune thrombocytopenia: Prevalence and prognostic implications.,"BACKGROUND Anti-platelet antibody testing may be useful for the diagnosis and management of childhood immune thrombocytopenia (ITP). OBJECTIVES Here we aimed to assess the prevalence and prognostic significance of anti-platelet glycoprotein-specific IgM and IgG antibodies. METHODS Children with newly diagnosed ITP were included at diagnosis and randomized to an intravenous immunoglobulins (IVIg) or careful observation group (TIKI trial). In this well-defined and longitudinally followed cohort (N = 179), anti-platelet glycoprotein-specific IgM and IgG antibodies were determined by monoclonal antibody-immobilization of platelet antigens. RESULTS The dominant circulating anti-platelet antibody class in childhood ITP was IgM (62% of patients); but IgG antibodies were also found (10%). Children without IgM platelet antibodies were older and more often female. There was weak evidence for an association between IgM anti-GP IIb/IIIa antibodies and an increased bleeding severity (P = .03). The IgM and IgG anti-platelet responses partially overlapped, and reactivity was frequently directed against multiple glycoproteins. During 1-year follow-up, children with IgM antibodies in the observation group displayed a faster platelet recovery compared to children without, also after adjustment for age and preceding infections (P = 7.1 × 10 -5 ). The small group of patients with detectable IgG anti-platelet antibodies exhibited an almost complete response to IVIg treatment (N = 12; P = .02), suggesting that IVIg was particularly efficacious in these children. CONCLUSIONS Testing for circulating anti-platelet antibodies may be helpful for the clinical prognostication and the guidance of treatment decisions in newly diagnosed childhood ITP. Our data suggest that the development of even more sensitive tests may further improve the clinical value of antibody testing.",2020,"During one year follow-up, children with IgM antibodies in the observation group displayed a faster platelet recovery compared to children without IgM, also after adjustment for age and preceding infections (P=7.1x10 -5 ).","['Childhood Immune Thrombocytopenia', 'Children with newly diagnosed ITP were included at diagnosis and randomized to an']",['intravenous immunoglobulins (IVIg) or careful observation'],"['anti-platelet glycoprotein-specific IgM and IgG antibodies', 'IgM and IgG anti-platelet responses', 'bleeding severity', 'platelet recovery', 'IgG antibodies']","[{'cui': 'C0231335', 'cui_str': 'Childhood (finding)'}, {'cui': 'C0272286', 'cui_str': 'Thrombocytopenia due to immune destruction'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0021540', 'cui_str': 'ITP'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}]","[{'cui': 'C0085297', 'cui_str': 'Immunoglobulins, Intravenous'}, {'cui': 'C0302523', 'cui_str': 'Observation'}]","[{'cui': 'C0086816', 'cui_str': 'Platelet Glycoproteins'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0020861', 'cui_str': 'IgM'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C0005821', 'cui_str': 'Platelets'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}]",179.0,0.0261397,"During one year follow-up, children with IgM antibodies in the observation group displayed a faster platelet recovery compared to children without IgM, also after adjustment for age and preceding infections (P=7.1x10 -5 ).","[{'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Schmidt', 'Affiliation': 'Department of Experimental Immunohematology, Sanquin Research, Amsterdam, the Netherlands.'}, {'ForeName': 'Katja M J', 'Initials': 'KMJ', 'LastName': 'Heitink-Polle', 'Affiliation': 'Department of Pediatric Hematology, University Medical Center Utrecht, Utrecht, the Netherlands.'}, {'ForeName': 'Leendert', 'Initials': 'L', 'LastName': 'Porcelijn', 'Affiliation': 'Laboratory for Platelet and Leukocyte Serology, Department of Immunohematology Diagnostics, Sanquin Diagnostic Services, Amsterdam, the Netherlands.'}, {'ForeName': 'C Ellen', 'Initials': 'CE', 'LastName': 'van der Schoot', 'Affiliation': 'Department of Experimental Immunohematology, Sanquin Research, Amsterdam, the Netherlands.'}, {'ForeName': 'Gestur', 'Initials': 'G', 'LastName': 'Vidarsson', 'Affiliation': 'Department of Experimental Immunohematology, Sanquin Research, Amsterdam, the Netherlands.'}, {'ForeName': 'Marrie C A', 'Initials': 'MCA', 'LastName': 'Bruin', 'Affiliation': 'Department of Pediatric Hematology, University Medical Center Utrecht, Utrecht, the Netherlands.'}, {'ForeName': 'Masja', 'Initials': 'M', 'LastName': 'de Haas', 'Affiliation': 'Laboratory for Platelet and Leukocyte Serology, Department of Immunohematology Diagnostics, Sanquin Diagnostic Services, Amsterdam, the Netherlands.'}]",Journal of thrombosis and haemostasis : JTH,['10.1111/jth.14762'] 338,31273283,Modafinil treatment modulates functional connectivity in stroke survivors with severe fatigue.,"Post-stroke fatigue has a significant impact on stroke survivors' mental and physical well-being. Our recent clinical trial showed significant reduction of post-stroke fatigue with modafinil treatment, however functional connectivity changes in response to modafinil have not yet been explored in stroke survivors with post-stroke fatigue. Twenty-eight participants (multidimensional fatigue inventory-20 ≥ 60) had MRI scans at baseline, and during modafinil and placebo treatment. Resting-state functional MRI data were obtained, and independent component analysis was used to extract functional networks. Resting-state functional connectivity (rsFC) was examined between baseline, modafinil and placebo treatment using permutation testing with threshold-free cluster enhancement. Overall twenty-eight participants (mean age: 62 ± 14.3, mean baseline MFI-20: 72.3 ± 9.24) were included. During modafinil treatment, increased rsFC was observed in the right hippocampus (p = 0.004, 11 voxels) compared to placebo. This coincided with lower rsFC in the left frontoparietal (inferior parietal lobule, p = 0.023, 13 voxels), somatosensory (primary somatosensory cortex; p = 0.009, 32 voxels) and mesolimbic network (temporal pole, p = 0.016, 35 voxels). In conclusion, modafinil treatment induces significant changes in rsFC in post-stroke fatigue. This modulation of rsFC may relate to a reduction of post-stroke fatigue; however, the relationship between sensory processing, neurotransmitter expression and fatigue requires further exploration.",2019,"During modafinil treatment, increased rsFC was observed in the right hippocampus (p = 0.004, 11 voxels) compared to placebo.","['stroke survivors with severe fatigue', 'Overall twenty-eight participants (mean age: 62\u2009±\u200914.3, mean baseline MFI-20: 72.3\u2009±\u20099.24) were included', 'Twenty-eight participants (multidimensional fatigue inventory-20']","['modafinil and placebo', 'modafinil', 'placebo', 'Modafinil']","['MRI scans', 'rsFC', 'functional connectivity', 'Resting-state functional connectivity (rsFC']","[{'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}]","[{'cui': 'C0066677', 'cui_str': 'modafinil'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}]",,0.122712,"During modafinil treatment, increased rsFC was observed in the right hippocampus (p = 0.004, 11 voxels) compared to placebo.","[{'ForeName': 'Milanka M', 'Initials': 'MM', 'LastName': 'Visser', 'Affiliation': 'School of Medicine and Public Health, Faculty of Health and Medicine, University of Newcastle, University Drive, Callaghan, 2308, New South Wales, Australia. milanka.visser@unimelb.edu.au.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Goodin', 'Affiliation': 'Department of Neurology, Royal Melbourne Hospital, University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Mark W', 'Initials': 'MW', 'LastName': 'Parsons', 'Affiliation': 'Department of Neurology, Royal Melbourne Hospital, University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Lillicrap', 'Affiliation': 'Department of Neurology, John Hunter Hospital, University of Newcastle, Newcastle, Australia.'}, {'ForeName': 'Neil J', 'Initials': 'NJ', 'LastName': 'Spratt', 'Affiliation': 'Department of Neurology, John Hunter Hospital, University of Newcastle, Newcastle, Australia.'}, {'ForeName': 'Christopher R', 'Initials': 'CR', 'LastName': 'Levi', 'Affiliation': 'Department of Neurology, John Hunter Hospital, University of Newcastle, Newcastle, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Bivard', 'Affiliation': 'Department of Neurology, Royal Melbourne Hospital, University of Melbourne, Melbourne, Australia.'}]",Scientific reports,['10.1038/s41598-019-46149-0'] 339,31278280,"Safety and Metabolism of Long-term Administration of NIAGEN (Nicotinamide Riboside Chloride) in a Randomized, Double-Blind, Placebo-controlled Clinical Trial of Healthy Overweight Adults.","Nicotinamide riboside (NR) is a newly discovered nicotinamide adenine dinucleotide (NAD + ) precursor vitamin. A crystal form of NR chloride termed NIAGEN is generally recognized as safe (GRAS) for use in foods and the subject of two New Dietary Ingredient Notifications for use in dietary supplements. To evaluate the kinetics and dose-dependency of NR oral availability and safety in overweight, but otherwise healthy men and women, an 8-week randomized, double-blind, placebo-controlled clinical trial was conducted. Consumption of 100, 300 and 1000 mg NR dose-dependently and significantly increased whole blood NAD + (i.e., 22%, 51% and 142%) and other NAD + metabolites within 2 weeks. The increases were maintained throughout the remainder of the study. There were no reports of flushing and no significant differences in adverse events between the NR and placebo-treated groups or between groups at different NR doses. NR also did not elevate low density lipoprotein cholesterol or dysregulate 1-carbon metabolism. Together these data support the development of a tolerable upper intake limit for NR based on human data.",2019,There were no reports of flushing and no significant differences in adverse events between the NR and placebo-treated groups or between groups at different NR doses.,"['overweight, but otherwise healthy men and women', 'Healthy Overweight Adults']","['Placebo', 'NIAGEN (Nicotinamide Riboside Chloride', 'Nicotinamide riboside (NR', 'placebo']","['whole blood NAD ', 'low density lipoprotein cholesterol or dysregulate 1-carbon metabolism', 'adverse events']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0068711', 'cui_str': 'pyridinium, 3-(aminocarbonyl)-1-beta-D-ribofuranosyl-'}, {'cui': 'C0008203', 'cui_str': 'Chlorides'}]","[{'cui': 'C0370231', 'cui_str': 'Whole blood (substance)'}, {'cui': 'C0621630', 'cui_str': 'NAD(S)'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0007009', 'cui_str': 'Carbon-12'}, {'cui': 'C0025520', 'cui_str': 'metabolism'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.38731,There were no reports of flushing and no significant differences in adverse events between the NR and placebo-treated groups or between groups at different NR doses.,"[{'ForeName': 'Dietrich', 'Initials': 'D', 'LastName': 'Conze', 'Affiliation': 'Chromadex Spherix Consulting, 11821 Parklawn Drive, Suite 310, Rockville, MD, 20852, United States.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Brenner', 'Affiliation': 'Department of Biochemistry, University of Iowa, 4-403 BSB, Iowa City, IA, 52242, United States. charles-brenner@uiowa.edu.'}, {'ForeName': 'Claire L', 'Initials': 'CL', 'LastName': 'Kruger', 'Affiliation': 'Chromadex Spherix Consulting, 11821 Parklawn Drive, Suite 310, Rockville, MD, 20852, United States. clairek@chromadex.com.'}]",Scientific reports,['10.1038/s41598-019-46120-z'] 340,31278329,Synergistic mechanisms of Sanghuang-Danshen phytochemicals on postprandial vascular dysfunction in healthy subjects: A network biology approach based on a clinical trial.,"With the increased risk of cardiovascular disease, the use of botanicals for vascular endothelial dysfunction has intensified. Here, we explored the synergistic mechanisms of Sanghuang-Danshen (SD) phytochemicals on the homeostatic protection against high-fat-induced vascular dysfunction in healthy subjects, using a network biology approach, based on a randomised crossover clinical trial. Seventeen differential markers identified in blood samples taken at 0, 3 and 6 h post-treatment, together with 12SD phytochemicals, were mapped onto the network platform, termed the context-oriented directed associations. The resulting vascular sub-networks illustrated associations between 10 phytochemicals with 32 targets implicated in 143 metabolic/signalling pathways. The three key events included adhesion molecule production (ellagic acid, fumaric acid and cryptotanshinone; VCAM-1, ICAM-1 and PLA2G2A; fatty acid metabolism), platelet activation (ellagic acid, protocatechuic acid and tanshinone IIA; VEGFA, APAF1 and ATF3; mTOR, p53, Rap1 and VEGF signalling pathways) and endothelial inflammation (all phytochemicals, except cryptotanshinone; 29 targets, including TP53 and CASP3; MAPK and PI3K-Akt signalling pathways, among others). Our collective findings demonstrate a potential of SD to protect unintended risks of vascular dysfunction in healthy subjects, providing a deeper understanding of the complicated synergistic mechanisms of signature phytochemicals in SD.",2019,The resulting vascular sub-networks illustrated associations between 10 phytochemicals with 32 targets implicated in 143 metabolic/signalling pathways.,['healthy subjects'],"['Sanghuang-Danshen phytochemicals', 'Sanghuang-Danshen (SD) phytochemicals']","['adhesion molecule production (ellagic acid, fumaric acid and cryptotanshinone; VCAM-1, ICAM-1 and PLA2G2A; fatty acid metabolism), platelet activation (ellagic acid, protocatechuic acid and tanshinone IIA; VEGFA, APAF1 and ATF3; mTOR, p53, Rap1 and VEGF signalling pathways) and endothelial inflammation (all phytochemicals, except cryptotanshinone; 29 targets, including TP53 and CASP3; MAPK and PI3K-Akt signalling pathways, among others', 'postprandial vascular dysfunction']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0696940', 'cui_str': 'Dan-Shen'}, {'cui': 'C0577749', 'cui_str': 'Plant Bioactive Compounds'}]","[{'cui': 'C0001511', 'cui_str': 'Tissue Adhesions'}, {'cui': 'C0567416', 'cui_str': 'Molecule (substance)'}, {'cui': 'C0033268'}, {'cui': 'C0013900', 'cui_str': 'Ellagic Acid'}, {'cui': 'C0060825', 'cui_str': 'Fumaric acid'}, {'cui': 'C0056557', 'cui_str': 'cryptotanshinone'}, {'cui': 'C0078056', 'cui_str': 'CD106 Antigens'}, {'cui': 'C0063695', 'cui_str': 'CD54 Antigens'}, {'cui': 'C0015684', 'cui_str': 'Fatty Acids'}, {'cui': 'C0025520', 'cui_str': 'metabolism'}, {'cui': 'C0032173', 'cui_str': 'Platelet Activation'}, {'cui': 'C0072489', 'cui_str': 'protocatechuic acid'}, {'cui': 'C0897640', 'cui_str': 'tanshinone II A'}, {'cui': 'C0078058', 'cui_str': 'Vascular Endothelial Growth Factor A'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0577749', 'cui_str': 'Plant Bioactive Compounds'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0291573', 'cui_str': 'CASP3'}, {'cui': 'C0037080', 'cui_str': 'Signal Pathways'}, {'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C0031847', 'cui_str': 'pathophysiology'}]",17.0,0.0284745,The resulting vascular sub-networks illustrated associations between 10 phytochemicals with 32 targets implicated in 143 metabolic/signalling pathways.,"[{'ForeName': 'Yeni', 'Initials': 'Y', 'LastName': 'Lim', 'Affiliation': 'Department of Nutritional Science and Food Management, Ewha Womans University, Seoul, 03760, Republic of Korea.'}, {'ForeName': 'Woochang', 'Initials': 'W', 'LastName': 'Hwang', 'Affiliation': 'Department of Bio and Brain Engineering, KAIST, Daejeon, 34141, Republic of Korea.'}, {'ForeName': 'Ji Yeon', 'Initials': 'JY', 'LastName': 'Kim', 'Affiliation': 'Department of Food Science and Technology, Seoul National University of Science and Technology, Seoul, 01811, Republic of Korea.'}, {'ForeName': 'Choong Hwan', 'Initials': 'CH', 'LastName': 'Lee', 'Affiliation': 'Department of Bioscience and Biotechnology, Konkuk University, Seoul, 05029, Republic of Korea.'}, {'ForeName': 'Yong-Jae', 'Initials': 'YJ', 'LastName': 'Kim', 'Affiliation': 'Department of Neurology, Ewha Womans University School of Medicine, Seoul, 07985, Republic of Korea.'}, {'ForeName': 'Doheon', 'Initials': 'D', 'LastName': 'Lee', 'Affiliation': 'Department of Bio and Brain Engineering, KAIST, Daejeon, 34141, Republic of Korea. dhlee@kaist.ac.kr.'}, {'ForeName': 'Oran', 'Initials': 'O', 'LastName': 'Kwon', 'Affiliation': 'Department of Nutritional Science and Food Management, Ewha Womans University, Seoul, 03760, Republic of Korea. orank@ewha.ac.kr.'}]",Scientific reports,['10.1038/s41598-019-46289-3'] 341,32278669,Effects of medicated enema and nasal drops using Triphaladi oil in the management of obesity - A pilot study.,"An open label, randomized, comparative, interventional pilot study was done to assess the effect of Lekhana Basti (medicated enema) and Rechana Nasya Karma (Errhine therapy) in the management of Sthoulya with special reference to obesity. In the study 30 clinically diagnosed patient of either sex were randomly divided into two groups. In Basti group, Lekhana Basti in Karma Basti manner was given for 30 days. Anuvasana Basti (enema with Triphaladi Taila) in the dose of 120 mL and Asthapana Basti (enema with Triphaladi decoction etc.) in the dose of approximately 960 mL was given. In Nasya group, Rechananasya on alternate days was given with Triphaladi (oil) in the dose of 0.5 mL per nostril for total 28 days. The patients were assessed on objective criteria such as such as weight, chest circumference, mid-arm circumference, mid-thigh circumference, triceps skin fold thickness, sub-scapular skin fold thickness, abdominal skin fold thickness, waist-hip ratio and lipid profile. It was observed that Basti group was a better intervention in providing relief, however there intergroup standard deviation was low on most of the variable expect the lipid profile. The results suggest that the Nasya Karma may be developed as a better practical approach in obesity management.",2020,"It was observed that Basti group was a better intervention in providing relief, however there intergroup standard deviation was low on most of the variable expect the lipid profile.","['Sthoulya with special reference to obesity', '30 clinically diagnosed patient of either sex']","['Asthapana Basti (enema with Triphaladi decoction etc', 'medicated enema and nasal drops using Triphaladi oil', 'Lekhana Basti (medicated enema) and Rechana Nasya Karma (Errhine therapy', 'Anuvasana Basti (enema with Triphaladi Taila', 'Triphaladi (oil']","['objective criteria such as such as weight, chest circumference, mid-arm circumference, mid-thigh circumference, triceps skin fold thickness, sub-scapular skin fold thickness, abdominal skin fold thickness, waist-hip ratio and lipid profile']","[{'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}]","[{'cui': 'C0014268', 'cui_str': 'Giving patient an enema'}, {'cui': 'C0991524', 'cui_str': 'Nasal drops'}, {'cui': 'C0028908', 'cui_str': 'Oil'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0424683', 'cui_str': 'Chest circumference'}, {'cui': 'C0444598', 'cui_str': 'Mid'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0332520', 'cui_str': 'Circumference'}, {'cui': 'C0039866', 'cui_str': 'Thigh structure'}, {'cui': 'C0424680', 'cui_str': 'Skin-fold thickness'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0578529', 'cui_str': 'Scapular skin fold thickness'}, {'cui': 'C0578530', 'cui_str': 'Abdominal skin fold thickness'}, {'cui': 'C0205682', 'cui_str': 'Waist/hip ratio'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}]",30.0,0.0370078,"It was observed that Basti group was a better intervention in providing relief, however there intergroup standard deviation was low on most of the variable expect the lipid profile.","[{'ForeName': 'Sarvesh Kumar', 'Initials': 'SK', 'LastName': 'Singh', 'Affiliation': 'Department of Panchakarma, National Institute of Ayurveda, Jaipur, Rajasthan, India. Electronic address: sarveshksingh21@gmail.com.'}, {'ForeName': 'Preeti', 'Initials': 'P', 'LastName': 'Swami', 'Affiliation': 'Department of Panchakarma, Dr.S.S.R.A.U, Jodhpur, Rajasthan, India.'}, {'ForeName': 'Kshipra', 'Initials': 'K', 'LastName': 'Rajoria', 'Affiliation': 'Department of Panchakarma, National Institute of Ayurveda, Jaipur, Rajasthan, India.'}]",Journal of Ayurveda and integrative medicine,['10.1016/j.jaim.2020.02.001'] 342,32279367,"An extension of the RITUX-ERAH study, multicenter randomized clinical trial comparing rituximab to placebo in acute antibody-mediated rejection after renal transplantation.","The treatment of active antibody-mediated rejection (ABMR) is still a matter of debate, the place of rituximab remaining controversial. The French multicenter double-blind RITUX-ERAH study included 38 patients with ABMR in the first year of renal transplantation. All patients received plasma exchanges, intravenous immunoglobulins, and corticosteroids and were randomly assigned rituximab or placebo infusion at day 5. Additional rituximab infusions were allowed. In the intention-to-treat analysis, 12-month graft survival and renal function were not different between the rituximab and placebo groups. Long-term data are needed to conclude. Evaluation of the 7-year outcomes of the RITUX-ERAH study patients according to the rituximab or placebo treatment received. Eleven patients received placebo and 27 at least one infusion of rituximab. Seven years after ABMR, death-censored kidney allograft survival and renal function were not different between the groups. The evolution of anti-HLA sensitization was similar. There was no statistically significant difference in the incidence of infectious or neoplastic complications, but to be noted, seven cancers developed in six patients treated with rituximab (mean period of 44 months post-ABMR). In this cohort, there was no benefit 7 years after ABMR of rituximab in addition to plasma exchanges, intravenous immunoglobulins, and steroids.",2020,"In the intention-to-treat analysis, 12-month graft survival and renal function were not different between the rituximab and placebo groups.","['38 patients with ABMR in the first year of renal transplantation', 'acute antibody-mediated rejection after renal transplantation']","['plasma exchanges, intravenous immunoglobulins, corticosteroids and were randomly assigned rituximab or placebo', 'rituximab or placebo', 'placebo', 'rituximab']","['death-censored kidney allograft survival and renal function', 'graft survival and renal function', 'incidence of infectious or neoplastic complications']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1608421', 'cui_str': 'Antibody-mediated rejection'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}]","[{'cui': 'C0032113', 'cui_str': 'Plasma exchange'}, {'cui': 'C0085297', 'cui_str': 'Intravenous Immunoglobulins'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0040739', 'cui_str': 'Allogeneic transplantation'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C0018131', 'cui_str': 'Graft Survival'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",38.0,0.401729,"In the intention-to-treat analysis, 12-month graft survival and renal function were not different between the rituximab and placebo groups.","[{'ForeName': 'Elodie', 'Initials': 'E', 'LastName': 'Bailly', 'Affiliation': 'Department of Nephrology, Hypertension, Dialysis and Kidney Transplantation, University hospital of Tours, Tours, France.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Ville', 'Affiliation': 'Institut de Transplantation Urologie Néphrologie (ITUN), CHU Nantes and Centre de Recherche en Transplantation et Immunologie UMR1064, INSERM, Université de Nantes, Nantes, France.'}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Blancho', 'Affiliation': 'Institut de Transplantation Urologie Néphrologie (ITUN), CHU Nantes and Centre de Recherche en Transplantation et Immunologie UMR1064, INSERM, Université de Nantes, Nantes, France.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Morelon', 'Affiliation': 'Department of Nephrology and Kidney Transplantation, University hospital of Lyon Edouard Herriot, Lyon, France.'}, {'ForeName': 'Jamal', 'Initials': 'J', 'LastName': 'Bamoulid', 'Affiliation': 'Department of Nephrology and Kidney Transplantation, University hospital of Besançon, Besançon, France.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Caillard', 'Affiliation': 'Nephrology-Transplantation Department, University Hospital, Strasbourg, France.'}, {'ForeName': 'Valérie', 'Initials': 'V', 'LastName': 'Chatelet', 'Affiliation': 'Centre Universitaire des Maladies Rénales, CHU de Caen, Caen, France.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Malvezzi', 'Affiliation': 'Department of Nephrology and Kidney Transplantation, University hospital of Grenoble, Grenoble, France.'}, {'ForeName': 'Jérôme', 'Initials': 'J', 'LastName': 'Tourret', 'Affiliation': 'Department of Nephrology and Kidney Transplantation, Assistance Publique - Hôpitaux de Paris, Pitié Salpêtrière Hospital, Paris, France.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Vuiblet', 'Affiliation': 'Department of Nephrology and Kidney Transplantation, University hospital of Reims, Reims, France.'}, {'ForeName': 'Dany', 'Initials': 'D', 'LastName': 'Anglicheau', 'Affiliation': 'Department of Nephrology and Kidney Transplantation, Assistance Publique - Hôpitaux de Paris, Necker Hospital, Paris, France.'}, {'ForeName': 'Dominique', 'Initials': 'D', 'LastName': 'Bertrand', 'Affiliation': 'Department of Nephrology and Kidney Transplantation, University hospital of Rouen, Rouen, France.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Grimbert', 'Affiliation': 'Service de Néphrologie et Transplantation, Pôle Cancérologie-Immunité-Transplantation-Infectiologie et Unité INSERM 955, CHU Henri Mondor et Université Paris-Est, Creteil, France.'}, {'ForeName': 'Fadi', 'Initials': 'F', 'LastName': 'Haidar', 'Affiliation': 'Department of Hemodialysis, CHT Noumea, Noumea, France.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Hazzan', 'Affiliation': 'Service de Néphrologie, CHU Lille and Inserm U995, Lille, France.'}, {'ForeName': 'Nassim', 'Initials': 'N', 'LastName': 'Kamar', 'Affiliation': 'Department of Nephrology and Kidney Transplantation, University Hospital of Toulouse, Toulouse, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Merville', 'Affiliation': 'Department of Nephrology, Transplantation, Dialysis and Apheresis, Bordeaux University Hospital, Bordeaux, France.'}, {'ForeName': 'Christiane', 'Initials': 'C', 'LastName': 'Mousson', 'Affiliation': 'Department of Nephrology and Kidney Transplantation, University Hospital of Dijon, Dijon, France.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Pernin', 'Affiliation': 'Department of Nephrology and Kidney Transplantation, University Hospital of Montpellier, Montpellier, France.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Pouteil-Noble', 'Affiliation': 'Department of Nephrology and Kidney Transplantation, E. Herriot Hospital, Université Lyon I, Lyon, France.'}, {'ForeName': 'Raj', 'Initials': 'R', 'LastName': 'Purgus', 'Affiliation': 'Department of Nephrology and Kidney Transplantation, University Hospital of Marseille, Marseille, France.'}, {'ForeName': 'Johnny', 'Initials': 'J', 'LastName': 'Sayegh', 'Affiliation': 'Department of Nephrology and Kidney Transplantation, University Hospital of Angers, Angers, France.'}, {'ForeName': 'Pierre-François', 'Initials': 'PF', 'LastName': 'Westeel', 'Affiliation': 'Department of Nephrology and Kidney Transplantation, University Hospital of Amiens, Amiens, France.'}, {'ForeName': 'Bénédicte', 'Initials': 'B', 'LastName': 'Sautenet', 'Affiliation': 'Department of Nephrology, Hypertension, Dialysis and Kidney Transplantation, University hospital of Tours, Tours, France.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Gatault', 'Affiliation': 'Department of Nephrology, Hypertension, Dialysis and Kidney Transplantation, University hospital of Tours, Tours, France.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Büchler', 'Affiliation': 'Department of Nephrology, Hypertension, Dialysis and Kidney Transplantation, University hospital of Tours, Tours, France.'}]",Transplant international : official journal of the European Society for Organ Transplantation,['10.1111/tri.13613'] 343,32278783,"Re-evaluation of the Uplift Clinical Trial, Using Age-Appropriate Spirometric Criteria.","BACKGROUND The clinical trial of tiotropium in COPD, UPLIFT, enrolled adults with a mean age of 65 years and moderate-to-severe airflow obstruction, based on criteria from the Global Initiative for Chronic Obstructive Lung Disease (GOLD). For the UPLIFT cohort, however, GOLD-based criteria are not age-appropriate. RESEARCH QUESTION Will the use of more age-appropriate criteria for airflow obstruction from the Global Lung Function Initiative (GLI) modify the spirometric classification of the UPLIFT cohort and, in turn, the mortality effect of tiotropium in COPD? STUDY DESIGN AND METHODS Baseline spirometric classifications were first cross-tabulated by GLI- and GOLD-based criteria. Next, in GLI- and GOLD-based airflow obstruction, modified intention-to-treat analyses evaluated differences in time to death over 4 years, comparing tiotropium vs placebo. Because treatment response may differ by COPD severity, the mortality effect also was evaluated within stratum defined by GLI- and GOLD-based moderate and severe airflow obstruction. RESULTS Of 5,898 participants with GOLD-based airflow-obstruction, staged as moderate in 2,739 (46.4%) and severe in 3,156 (53.5%), GLI-based criteria established airflow obstruction in 5,750 (97.5%), staged as moderate in 795 (13.5%) and severe in 4,947 (83.9%). Relative to placebo, tiotropium yielded statistically nonsignificant adjusted hazard ratios (adjHRs) (95% CI) for death of 0.91 (0.80-1.04) and 0.91 (0.79-1.03) in GLI- and GOLD-based airflow obstruction, respectively. However, statistically significant effect modification was observed, but only in GLI-based moderate and severe airflow-obstruction, with tiotropium yielding adjHRs for death of 0.53 (0.34-0.81) and 0.99 (0.86-1.13), respectively. The P value for interaction was .007. INTERPRETATION Mortality reduction by tiotropium was only statistically significant in GLI-based moderate airflow-obstruction, a group that was underrepresented in UPLIFT because of severity misclassification by the original GOLD-based enrollment criteria.",2020,"Relative to placebo, tiotropium yielded statistically non-significant adjusted hazard ratios (adjHRs) (95% confidence interval) for death of 0.91 (0.80, 1.04) and 0.91 (0.79, 1.03) in GLI- and GOLD-based airflow-obstruction, respectively.","['and Methods', 'chronic obstructive pulmonary disease (COPD), i.e. UPLIFT, enrolled adults with a mean age of 65 years and moderate-to-severe airflow-obstruction, based on criteria from the Global Initiative for Chronic Obstructive Lung Disease (GOLD', '5898 participants with GOLD-based']","['placebo, tiotropium', 'tiotropium', 'tiotropium vs. placebo']","['GLI-based moderate and severe airflow-obstruction', 'GLI-based criteria established airflow-obstruction', 'hazard ratios (adjHRs', 'mortality effect', 'Mortality reduction', 'airflow-obstruction']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0231999', 'cui_str': 'Airflow'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0424093', 'cui_str': 'Initiative'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0213771', 'cui_str': 'tiotropium'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0424093', 'cui_str': 'Initiative'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0231999', 'cui_str': 'Airflow'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0443211', 'cui_str': 'Established'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",5898.0,0.179374,"Relative to placebo, tiotropium yielded statistically non-significant adjusted hazard ratios (adjHRs) (95% confidence interval) for death of 0.91 (0.80, 1.04) and 0.91 (0.79, 1.03) in GLI- and GOLD-based airflow-obstruction, respectively.","[{'ForeName': 'Carlos A', 'Initials': 'CA', 'LastName': 'Vaz Fragoso', 'Affiliation': 'Veterans Affairs (VA) Connecticut Healthcare System, West Haven; Yale University School of Medicine, Department of Internal Medicine, New Haven, CT. Electronic address: carlos.fragoso@yale.edu.'}, {'ForeName': 'Linda S', 'Initials': 'LS', 'LastName': 'Leo-Summers', 'Affiliation': 'Yale University School of Medicine, Department of Internal Medicine, New Haven, CT.'}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Gill', 'Affiliation': 'Yale University School of Medicine, Department of Internal Medicine, New Haven, CT.'}, {'ForeName': 'Gail J', 'Initials': 'GJ', 'LastName': 'McAvay', 'Affiliation': 'Yale University School of Medicine, Department of Internal Medicine, New Haven, CT.'}]",Chest,['10.1016/j.chest.2020.02.070'] 344,32277008,Effects of Weight Loss and Weight Regain on Circulating Biomarkers in Overweight/Obese Breast Cancer Survivors Enrolled in a Weight Loss Trial in the Rural Midwest.,"BACKGROUND Obesity is associated with worse breast cancer prognosis, however little is known about the level of weight loss required to improve pathway biomarkers. The effects of weight regain on biomarkers are also largely unknown. METHODS Overweight/obese breast cancer survivors enrolled in an 18-month behavioral weight loss trial provided weight and serum biomarkers [leptin, adiponectin, insulin, plasminogen activator inhibitor-1 (PAI-1), IL-6, TNFα, and hepatocyte growth factor HGF] at baseline, 6, and 18 months ( n = 138). Change in biomarkers over time and by weight loss thresholds were examined. RESULTS Mean weight loss at 6 months was 13.3 ± 5.0 kg; from 6 to 18 months, mean regain was 4.0 ± 5.2 kg. Favorable biomarker modulations were observed at 6 months for leptin, adiponectin, insulin, PAI-1, IL-6, and HGF ( P < 0.006 to P < 0.0001). These changes remained significant overall at 18 months despite attenuation in some. Women who lost <10% of baseline weight showed significantly smaller modulation effects for leptin ( P < 0.0001), adiponectin:leptin (A/L) ratio ( P < 0.0001), PAI-1 ( P < 0.001), and insulin ( P = 0.003) compared with women who lost >10%. Women who lost >10% observed a significant increase in adiponectin ( P < 0.0001), and these women continued to show improved adiponectin from 6 to 18 months despite weight regain. Physical activity contributed additional effects on biomarker change for leptin, A/L ratio, and PAI-1. CONCLUSIONS These findings are consistent with a clinical target of 10% weight. IMPACT Sustained increases in adiponectin likely confer benefits for breast cancer prognosis even with weight regain.",2020,"Favorable biomarker modulations were observed at 6 months for leptin, adiponectin, insulin, PAI-1, IL-6, and HGF (p<0.006 to p<0.0001).","['Overweight/Obese Breast Cancer Survivors Enrolled in a Weight Loss Trial in the Rural Midwest', 'Overweight/obese breast cancer survivors enrolled in an 18-month behavioral weight loss trial provided']",['Weight Loss and Weight Regain'],"['Favorable biomarker modulations', 'smaller modulation effects for leptin (p<0.0001), adiponectin:leptin (A/L) ratio (p<0.0001), PAI-1', 'biomarker change for leptin, A/L ratio, and PAI-1', 'leptin, adiponectin, insulin, PAI-1, IL-6, and HGF', 'PAI-1], interleukin-6 [IL-6], tumor necrosis factor alpha [TNFα], and hepatocyte growth factor [HGF', 'Mean weight loss', 'adiponectin', 'weight and serum biomarkers (leptin, adiponectin, insulin, plasminogen activator inhibitor-1']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}]","[{'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0030190', 'cui_str': 'Plasminogen activator inhibitor-1'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C1168005', 'cui_str': 'Alpha tumour necrosis factor'}, {'cui': 'C0062534', 'cui_str': 'Scatter Factor'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0229671', 'cui_str': 'Serum'}]",138.0,0.0228327,"Favorable biomarker modulations were observed at 6 months for leptin, adiponectin, insulin, PAI-1, IL-6, and HGF (p<0.006 to p<0.0001).","[{'ForeName': 'Christie A', 'Initials': 'CA', 'LastName': 'Befort', 'Affiliation': 'University of Kansas Medical Center, University of Kansas Cancer Center, Kansas City, Kansas. cbefort@kumc.edu.'}, {'ForeName': 'Bruce F', 'Initials': 'BF', 'LastName': 'Kimler', 'Affiliation': 'University of Kansas Medical Center, University of Kansas Cancer Center, Kansas City, Kansas.'}, {'ForeName': 'Leonidas E', 'Initials': 'LE', 'LastName': 'Bantis', 'Affiliation': 'University of Kansas Medical Center, University of Kansas Cancer Center, Kansas City, Kansas.'}, {'ForeName': 'Teresa A', 'Initials': 'TA', 'LastName': 'Phillips', 'Affiliation': 'University of Kansas Medical Center, University of Kansas Cancer Center, Kansas City, Kansas.'}, {'ForeName': 'Carol J', 'Initials': 'CJ', 'LastName': 'Fabian', 'Affiliation': 'University of Kansas Medical Center, University of Kansas Cancer Center, Kansas City, Kansas.'}]","Cancer epidemiology, biomarkers & prevention : a publication of the American Association for Cancer Research, cosponsored by the American Society of Preventive Oncology",['10.1158/1055-9965.EPI-19-1572'] 345,32270133,"""When I Eat Well, I Will Be Healthy, and the Child Will Also Be Healthy"": Maternal Nutrition among HIV-Infected Women Enrolled in a Livelihood Intervention in Western Kenya.","Background Food insecurity remains a major obstacle to achieving health and well-being for individuals living with HIV in western Kenya. Studies have shown that pregnant women are vulnerable to experiencing food insecurity worldwide, with significant consequences for both maternal and child health. The Shamba Maisha cluster randomized controlled trial in western Kenya (which means ""farming for life"" in Swahili) tested the effects of a multisectoral livelihood intervention consisting of agricultural and finance trainings, farm inputs, and a loan on health and food security among 746 farmers living with HIV in Kisumu, Homa Bay, and Migori Counties. Objectives We conducted a qualitative substudy within the Shamba Maisha trial to understand the experiences and perspectives of pregnant women living with HIV enrolled in the trial. Methods Thirty women who had experienced a pregnancy during the Shamba Maisha study period, comprising 20 women in the intervention arm and 10 women in the control arm, completed in-depth interviews using a semistructured interview guide. Results Intervention participants interviewed noted improvements in maternal nutrition compared with previous pregnancies, which they attributed to the livelihood intervention. Key identified pathways to improved nutrition included improved access to vegetables, increased variety of diet through vegetable sales, and improved nutritional awareness. Women in the intervention arm also perceived increased weight gain compared with prior pregnancies and increased strength and energy throughout pregnancy. Conclusions Livelihood interventions represent a promising solution to alleviate food insecurity for pregnant women in order to improve maternal and child health outcomes.This trial was registered at clinicaltrials.gov as NCT02815579.",2020,"Conclusions Livelihood interventions represent a promising solution to alleviate food insecurity for pregnant women in order to improve maternal and child health outcomes.","['pregnant women living with HIV enrolled in the trial', 'Thirty women who had experienced a pregnancy during the Shamba Maisha study period, comprising 20 women in the intervention arm and 10 women in the control arm, completed in-depth interviews using a semistructured interview guide', 'pregnant women', 'western Kenya (which means ""farming for life"" in Swahili', 'HIV-Infected Women Enrolled in a Livelihood Intervention in Western Kenya', 'individuals living with HIV in western Kenya', '746 farmers living with HIV in Kisumu, Homa Bay, and Migori Counties']",['multisectoral livelihood intervention'],"['nutritional awareness', 'strength and energy throughout pregnancy', 'maternal nutrition', 'weight gain']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0022558', 'cui_str': 'Kenya'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0557759', 'cui_str': 'Farming environment'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0038977', 'cui_str': 'Swahili language'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0221460', 'cui_str': 'Farmer'}, {'cui': 'C3203003', 'cui_str': 'Bays'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C1720845', 'cui_str': 'Maternal Nutritional Physiological Phenomenon'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}]",20.0,0.0842693,"Conclusions Livelihood interventions represent a promising solution to alleviate food insecurity for pregnant women in order to improve maternal and child health outcomes.","[{'ForeName': 'Annie', 'Initials': 'A', 'LastName': 'McDonough', 'Affiliation': 'San Francisco School of Medicine, University of California, San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Sheri D', 'Initials': 'SD', 'LastName': 'Weiser', 'Affiliation': 'Division of HIV, Infectious Diseases, and Global Medicine, University of California, San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Afkera', 'Initials': 'A', 'LastName': 'Daniel', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Elly', 'Initials': 'E', 'LastName': 'Weke', 'Affiliation': 'Centre for Microbiology Research, Kenya Medical Research Institute, Nairobi, Kenya.'}, {'ForeName': 'Pauline', 'Initials': 'P', 'LastName': 'Wekesa', 'Affiliation': 'Centre for Microbiology Research, Kenya Medical Research Institute, Nairobi, Kenya.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Burger', 'Affiliation': 'Department of Obstetrics, Gynecology & Reproductive Sciences, University of California, San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Lila', 'Initials': 'L', 'LastName': 'Sheira', 'Affiliation': 'Division of HIV, Infectious Diseases, and Global Medicine, University of California, San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Bukusi', 'Affiliation': 'Centre for Microbiology Research, Kenya Medical Research Institute, Nairobi, Kenya.'}, {'ForeName': 'Craig R', 'Initials': 'CR', 'LastName': 'Cohen', 'Affiliation': 'Department of Obstetrics, Gynecology & Reproductive Sciences, University of California, San Francisco, San Francisco, CA, USA.'}]",Current developments in nutrition,['10.1093/cdn/nzaa032'] 346,32278779,"Association of Guideline-Recommended COPD Inhaler Regimens With Mortality, Respiratory Exacerbations, and Quality of Life: A Secondary Analysis of the Long-Term Oxygen Treatment Trial.","BACKGROUND Although inhaled therapy reduces exacerbations among patients with COPD, the effectiveness of providing inhaled treatment per risk stratification models remains unclear. RESEARCH QUESTION Are inhaled regimens that align with the 2017 Global Initiative for Chronic Obstructive Lung Disease (GOLD) strategy associated with clinically important outcomes? STUDY DESIGN AND METHODS We conducted secondary analyses of Long-term Oxygen Treatment Trial (LOTT) data. The trial enrolled patients with COPD with moderate resting or exertional hypoxemia between 2009 and 2015. Our exposure was the patient-reported inhaled regimen at enrollment, categorized as either aligning with, undertreating, or potentially overtreating per the 2017 GOLD strategy. Our primary composite outcome was time to death or first hospitalization for COPD. Additional outcomes included individual components of the composite outcome and time to first exacerbation. We generated multivariable Cox proportional hazard models across strata of GOLD-predicted exacerbation risk (high vs low) to estimate between-group hazard ratios for time to event outcomes. We adjusted models a priori for potential confounders, clustered by site. RESULTS The trial enrolled 738 patients (73.4% men; mean age, 68.8 years). Of the patients, 571 (77.4%) were low risk for future exacerbations. Of the patients, 233 (31.6%) reported regimens aligning with GOLD recommendations; most regimens (54.1%) potentially overtreated. During a 2.3-year median follow-up, 332 patients (44.9%) experienced the composite outcome. We found no difference in time to composite outcome or death among patients reporting regimens aligning with recommendations compared with undertreated patients. Among patients at low risk, potential overtreatment was associated with higher exacerbation risk (hazard ratio, 1.42; 95% CI, 1.09-1.87), whereas inhaled corticosteroid treatment was associated with 64% higher risk of pneumonia (incidence rate ratio, 1.64; 95% CI, 1.01-2.66). INTERPRETATION Among patients with COPD with moderate hypoxemia, we found no difference in clinical outcomes between inhaled regimens aligning with the 2017 GOLD strategy compared with those that were undertreated. These findings suggest the need to reevaluate the effectiveness of risk stratification model-based inhaled treatment strategies.",2020,We found no difference in time-to composite outcome or death among patients reporting regimens aligning with recommendations compared to undertreated patients.,"['COPD patients with moderate hypoxemia', 'enrolled COPD patients with moderate resting or exertional hypoxemia between 2009-2015', 'and Methods', 'COPD patients', '571 patients (77.4%) were low-risk for future exacerbations', '738 patients; 73.4% were male with mean age 68.8 years']",[],"['individual components of the composite outcome and time-to first exacerbation', 'exacerbation risk', 'COPD Inhaler Regimenswith Mortality, Respiratory Exacerbations, and Quality of Life', 'risk of pneumonia', 'time-to composite outcome or death', 'time-to death or first hospitalization for COPD']","[{'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0700292', 'cui_str': 'Hypoxemia'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0016884', 'cui_str': 'Future'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]",[],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0021461', 'cui_str': 'Inhaler'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}]",738.0,0.234867,We found no difference in time-to composite outcome or death among patients reporting regimens aligning with recommendations compared to undertreated patients.,"[{'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Keller', 'Affiliation': 'Division of Pulmonary, Critical Care, and Sleep Medicine, Department of Medicine, University of Washington, Seattle, WA. Electronic address: tlk33@uw.edu.'}, {'ForeName': 'Laura J', 'Initials': 'LJ', 'LastName': 'Spece', 'Affiliation': 'Division of Pulmonary, Critical Care, and Sleep Medicine, Department of Medicine, University of Washington, Seattle, WA; Health Services Research & Development Center of Innovation for Veteran-centered and Value-driven Care, VA Puget Sound Healthcare System, Seattle, WA.'}, {'ForeName': 'Lucas M', 'Initials': 'LM', 'LastName': 'Donovan', 'Affiliation': 'Division of Pulmonary, Critical Care, and Sleep Medicine, Department of Medicine, University of Washington, Seattle, WA; Health Services Research & Development Center of Innovation for Veteran-centered and Value-driven Care, VA Puget Sound Healthcare System, Seattle, WA.'}, {'ForeName': 'Edmunds', 'Initials': 'E', 'LastName': 'Udris', 'Affiliation': 'Health Services Research & Development Center of Innovation for Veteran-centered and Value-driven Care, VA Puget Sound Healthcare System, Seattle, WA.'}, {'ForeName': 'Scott S', 'Initials': 'SS', 'LastName': 'Coggeshall', 'Affiliation': 'Health Services Research & Development Center of Innovation for Veteran-centered and Value-driven Care, VA Puget Sound Healthcare System, Seattle, WA.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Griffith', 'Affiliation': 'Division of Pulmonary, Critical Care, and Sleep Medicine, Department of Medicine, University of Washington, Seattle, WA; Health Services Research & Development Center of Innovation for Veteran-centered and Value-driven Care, VA Puget Sound Healthcare System, Seattle, WA.'}, {'ForeName': 'Alexander D', 'Initials': 'AD', 'LastName': 'Bryant', 'Affiliation': 'Division of Pulmonary, Critical Care, and Sleep Medicine, Department of Medicine, University of Washington, Seattle, WA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Casaburi', 'Affiliation': 'Los Angeles Biomedical Research Institute at Harbor - UCLA Medical Center, Torrance, CA.'}, {'ForeName': 'J Allen', 'Initials': 'JA', 'LastName': 'Cooper', 'Affiliation': 'Birmingham VA Medical Center and the Lung Health Center, University of Alabama Birmingham, Birmingham, AL.'}, {'ForeName': 'Gerard J', 'Initials': 'GJ', 'LastName': 'Criner', 'Affiliation': 'Temple University School of Medicine, Philadelphia, PA.'}, {'ForeName': 'Philip T', 'Initials': 'PT', 'LastName': 'Diaz', 'Affiliation': '201 Heart Lung Institute, Ohio State University School of Medicine, Columbus, OH.'}, {'ForeName': 'Anne L', 'Initials': 'AL', 'LastName': 'Fuhlbrigge', 'Affiliation': 'University of Colorado School of Medicine, Aurora, CO.'}, {'ForeName': 'Steven E', 'Initials': 'SE', 'LastName': 'Gay', 'Affiliation': 'University of Michigan School of Medicine, Ann Arbor, MI.'}, {'ForeName': 'Richard E', 'Initials': 'RE', 'LastName': 'Kanner', 'Affiliation': 'University of Utah Health Sciences Center, Salt Lake City, UT.'}, {'ForeName': 'Fernando J', 'Initials': 'FJ', 'LastName': 'Martinez', 'Affiliation': 'Weill Cornell Medical College, New York, NY.'}, {'ForeName': 'Ralph J', 'Initials': 'RJ', 'LastName': 'Panos', 'Affiliation': 'Cincinnati VA Medical Center and University of Cincinnati College of Medicine, Cincinnati, OH.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Shade', 'Affiliation': 'Johns Hopkins University Bloomberg School of Public Health, Baltimore, MD.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Sternberg', 'Affiliation': 'Johns Hopkins University Bloomberg School of Public Health, Baltimore, MD.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Stibolt', 'Affiliation': 'Kaiser Permanente Center for Health Research, Portland, OR.'}, {'ForeName': 'James K', 'Initials': 'JK', 'LastName': 'Stoller', 'Affiliation': 'Cleveland Clinic Foundation, Cleveland, OH.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Tonascia', 'Affiliation': 'Johns Hopkins University Bloomberg School of Public Health, Baltimore, MD.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Wise', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD.'}, {'ForeName': 'Roger D', 'Initials': 'RD', 'LastName': 'Yusen', 'Affiliation': 'Washington University School of Medicine, Saint Louis, MO.'}, {'ForeName': 'David H', 'Initials': 'DH', 'LastName': 'Au', 'Affiliation': 'Division of Pulmonary, Critical Care, and Sleep Medicine, Department of Medicine, University of Washington, Seattle, WA; Health Services Research & Development Center of Innovation for Veteran-centered and Value-driven Care, VA Puget Sound Healthcare System, Seattle, WA.'}, {'ForeName': 'Laura C', 'Initials': 'LC', 'LastName': 'Feemster', 'Affiliation': 'Division of Pulmonary, Critical Care, and Sleep Medicine, Department of Medicine, University of Washington, Seattle, WA; Health Services Research & Development Center of Innovation for Veteran-centered and Value-driven Care, VA Puget Sound Healthcare System, Seattle, WA.'}]",Chest,['10.1016/j.chest.2020.02.073'] 347,32278781,"Effect of Venlafaxine on Apnea-Hypopnea Index in Patients With Sleep Apnea: A Randomized, Double-Blind Crossover Study.","BACKGROUND One of the key mechanisms underlying OSA is reduced pharyngeal muscle tone during sleep. Data suggest that pharmacologic augmentation of central serotonergic/adrenergic tone increases pharyngeal muscle tone. RESEARCH QUESTION We hypothesized that venlafaxine, a serotonin-norepinephrine reuptake inhibitor, would improve OSA severity. STUDY DESIGN AND METHODS In this mechanistic, randomized, double-blind, placebo-controlled crossover trial, 20 patients with OSA underwent two overnight polysomnograms ≥ 4 days apart, receiving either 50 mg of immediate-release venlafaxine or placebo before bedtime. Primary outcomes were the apnea-hypopnea index (AHI) and peripheral oxygen saturation (Spo 2 ) nadir, and secondary outcomes included sleep parameters and pathophysiologic traits with a view toward understanding the impact of venlafaxine on mechanisms underlying OSA. RESULTS Overall, there was no significant difference between venlafaxine and placebo regarding AHI (mean reduction, -5.6 events/h [95% CI, -12.0 to 0.9]; P = .09) or Spo 2 nadir (median increase, +1.0% [-0.5 to 5]; P = .11). Venlafaxine reduced total sleep time, sleep efficiency, and rapid eye movement (REM) sleep, while increasing non-REM stage 1 sleep (P all  < .05). On the basis of exploratory post hoc analyses venlafaxine decreased (""improved"") the ventilatory response to arousal (-30%; P = .049) and lowered (""worsened"") the predicted arousal threshold (-13%; [P = .02]; ie, more arousable), with no effects on other pathophysiologic traits (P all  ≥ .3). Post hoc analyses further suggested effect modification by arousal threshold (P = .002): AHI improved by 19% in patients with a high arousal threshold (-10.9 events/h [-3.9 to -17.9]) but tended to increase in patients with a low arousal threshold (+7 events/h [-2.0 to 16]). Other predictors of response were elevated AHI and less collapsible upper airway anatomy at baseline (|r| > 0.5, P ≤ .02). INTERPRETATION In unselected patients, venlafaxine simultaneously worsened and improved various pathophysiologic traits, resulting in a zero net effect. Careful patient selection based on pathophysiologic traits, or combination therapy with drugs countering its alerting effects, may produce a more robust response. TRIAL REGISTRY ClinicalTrials.gov; No.: NCT02714400; URL: www.clinicaltrials.gov.",2020,"Based on exploratory post hoc analyses venlafaxine decreased (""improved"") the ventilatory response to arousal (-30%, P=.049) and lowered (""worsened"") the predicted arousal threshold (-13%, P=.02; i.e. more arousable), with no effects on other pathophysiological traits (P all ≥.3).","['and Methods', 'obstructive sleep apnea (OSA', 'Patients with Sleep Apnea ', '20 OSA patients underwent two', 'patients with a high arousal threshold (-10.9/h']","['venlafaxine', 'Venlafaxine', 'overnight polysomnograms >4days apart receiving either 50mg immediate-release venlafaxine or placebo', 'placebo']","['Apnea Hypopnea Index', 'ventilatory response to arousal', 'total sleep time, sleep efficiency and rapid eye movement (REM) sleep', 'pathophysiological traits', 'apnea hypopnea index (AHI) and SpO 2 nadir; secondary outcomes included sleep parameters and pathophysiological traits with a view towards understanding its impact on mechanisms underlying OSA']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037315', 'cui_str': 'Sleep apnea'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}]","[{'cui': 'C0078569', 'cui_str': 'venlafaxine'}, {'cui': 'C0439583', 'cui_str': 'Overnight'}, {'cui': 'C0162701', 'cui_str': 'Polysomnography'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C2111846', 'cui_str': 'Apnea Hypopnea Index'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0037322', 'cui_str': 'Rapid eye movement sleep'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0449911', 'cui_str': 'View'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}]",20.0,0.290939,"Based on exploratory post hoc analyses venlafaxine decreased (""improved"") the ventilatory response to arousal (-30%, P=.049) and lowered (""worsened"") the predicted arousal threshold (-13%, P=.02; i.e. more arousable), with no effects on other pathophysiological traits (P all ≥.3).","[{'ForeName': 'Christopher N', 'Initials': 'CN', 'LastName': 'Schmickl', 'Affiliation': 'Division of Pulmonary, Critical Care and Sleep Medicine, University of California, San Diego, San Diego, CA.'}, {'ForeName': 'Yanru', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Division of Pulmonary, Critical Care and Sleep Medicine, University of California, San Diego, San Diego, CA; Department of Otorhinolaryngology Head and Neck Surgery, Sleep Medicine Center, Beijing Tongren Hospital, Capital Medical University, Beijing, China. Electronic address: liyanruru@aliyun.com.'}, {'ForeName': 'Jeremy E', 'Initials': 'JE', 'LastName': 'Orr', 'Affiliation': 'Division of Pulmonary, Critical Care and Sleep Medicine, University of California, San Diego, San Diego, CA.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Jen', 'Affiliation': 'Division of Respiratory Medicine, University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'Scott A', 'Initials': 'SA', 'LastName': 'Sands', 'Affiliation': ""Division of Sleep and Circadian Disorders, Brigham and Women's Hospital and Harvard Medical School, Boston, MA.""}, {'ForeName': 'Bradley A', 'Initials': 'BA', 'LastName': 'Edwards', 'Affiliation': 'Sleep and Circadian Medicine Laboratory, Department of Physiology, School of Biomedical Sciences and Biomedical Discovery Institute, Monash University, Melbourne, VIC, Australia; Turner Institute for Brain and Mental Health, Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'DeYoung', 'Affiliation': 'Division of Pulmonary, Critical Care and Sleep Medicine, University of California, San Diego, San Diego, CA.'}, {'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Owens', 'Affiliation': 'Division of Pulmonary, Critical Care and Sleep Medicine, University of California, San Diego, San Diego, CA.'}, {'ForeName': 'Atul', 'Initials': 'A', 'LastName': 'Malhotra', 'Affiliation': 'Division of Pulmonary, Critical Care and Sleep Medicine, University of California, San Diego, San Diego, CA.'}]",Chest,['10.1016/j.chest.2020.02.074'] 348,31591483,Role of appetitive phenotype trajectory groups on child body weight during a family-based treatment for children with overweight or obesity.,"OBJECTIVE Emerging evidence suggests that individual appetitive traits may usefully explain patterns of weight loss in behavioral weight loss treatments for children. The objective of this study was to identify trajectories of child appetitive traits and the impact on child weight changes over time. METHODS Secondary data analyses of a randomized noninferiority trial conducted between 2011 and 2015 evaluated children's appetitive traits and weight loss. Children with overweight and obesity (mean age = 10.4; mean BMI z = 2.0; 67% girls; 32% Hispanic) and their parent (mean age = 42.9; mean BMI = 31.9; 87% women; 31% Hispanic) participated in weight loss programs and completed assessments at baseline, 3, 6,12, and 24 months. Repeated assessments of child appetitive traits, including satiety responsiveness, food responsiveness and emotional eating, were used to identify parsimonious grouping of change trajectories. Linear mixed-effects models were used to identify the impact of group trajectory on child BMIz change over time. RESULTS One hundred fifty children and their parent enrolled in the study. The three-group trajectory model was the most parsimonious and included a high satiety responsive group (HighSR; 47.4%), a high food responsive group (HighFR; 34.6%), and a high emotional eating group (HighEE; 18.0%). Children in all trajectories lost weight at approximately the same rate during treatment, however, only the HighSR group maintained their weight loss during follow-ups, while the HighFR and HighEE groups regained weight (adjusted p-value < 0.05). CONCLUSIONS Distinct trajectories of child appetitive traits were associated with differential weight loss maintenance. Identified high-risk subgroups may suggest opportunities for targeted intervention and maintenance programs.",2019,"Repeated assessments of child appetitive traits, including satiety responsiveness, food responsiveness and emotional eating, were used to identify parsimonious grouping of change trajectories.","['children', 'children with overweight or obesity', 'Children with overweight and obesity (mean age\u2009', 'One hundred fifty children and their parent enrolled in the study', ""2011 and 2015 evaluated children's appetitive traits and weight loss""]",['appetitive phenotype trajectory'],"['child body weight', 'differential weight loss maintenance', 'child BMIz change over time', 'weight loss', 'child appetitive traits, including satiety responsiveness, food responsiveness and emotional eating']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}]","[{'cui': 'C1314763', 'cui_str': 'Phenotyping (qualifier value)'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0443199', 'cui_str': 'Differential (qualifier value)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0036239', 'cui_str': 'Satiations'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}]",150.0,0.0200187,"Repeated assessments of child appetitive traits, including satiety responsiveness, food responsiveness and emotional eating, were used to identify parsimonious grouping of change trajectories.","[{'ForeName': 'Kerri N', 'Initials': 'KN', 'LastName': 'Boutelle', 'Affiliation': 'Department of Pediatrics, UC San Diego, La Jolla, CA, USA. kboutelle@ucsd.edu.'}, {'ForeName': 'D Eastern', 'Initials': 'DE', 'LastName': 'Kang Sim', 'Affiliation': 'Department of Pediatrics, UC San Diego, La Jolla, CA, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Manzano', 'Affiliation': 'Department of Pediatrics, UC San Diego, La Jolla, CA, USA.'}, {'ForeName': 'Kyung E', 'Initials': 'KE', 'LastName': 'Rhee', 'Affiliation': 'Department of Pediatrics, UC San Diego, La Jolla, CA, USA.'}, {'ForeName': 'Scott J', 'Initials': 'SJ', 'LastName': 'Crow', 'Affiliation': 'Department of Psychiatry, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Strong', 'Affiliation': 'Department of Family Medicine and Public Health, UC San Diego, La Jolla, CA, USA.'}]",International journal of obesity (2005),['10.1038/s41366-019-0463-4'] 349,32255785,Effects of photobiomodulation on interleukin-10 and nitrites in individuals with relapsing-remitting multiple sclerosis - Randomized clinical trial.,"OBJECTIVE Investigate the effects of photobiomodulation (PBM) on the expression of IL-10 and nitrites in individuals with Relapsing-Remitting multiple sclerosis (MS), as these biomarkers play a fundamental role in the physiopathology of the disease. The modulation of IL-10 and nitrites through treatment with PBM may be a novel treatment modality for MS. METHODS A randomized, uncontrolled, clinical trial was conducted involving 14 individuals with a diagnosis of Relapsing-Remitting MS and a score of up to 6.0 on the Expanded Disability Status Scale (EDSS). THE PARTICIPANTS WERE RANDOMIZED TO TWO GROUPS Group 1 -PBM in the sublingual region; Group 2 -PBM over the radial artery. Irradiation was administered with a wavelength of 808 nm and output power of 100 mW for 360 seconds twice a week, totaling 24 sessions. Peripheral blood was analyzed for the determination of serum levels of IL-10 and nitrites. RESULTS After treatment with PBM, the expression of IL-10 increased in both the sublingual group (pre-treatment: 2.8 ± 1.4 pg/ml; post-treatment: 8.3 ± 2.4 pg/ml) and the radial artery group (pre-treatment: 2.7 pg/ml ± 1.4; post-treatment: 11.7 ± 3.8 pg/ml). In contrast, nitrite levels were not modulated in the sublingual group (pre-treatment: 65 ± 50 nmol/mg protein; post-treatment: 51 ± 42 nmol/mg protein) or the radial artery group (pre-treatment: 51 ± 16 nmol/mg protein; post-treatment: 42 ± 7 nmol/mg protein). CONCLUSION Treatment with PBM positively modulated the expression of IL-10 but had no effect on nitrite levels. Further studies should be conducted with a larger sample and a control group, as PBM may be a promising complementary treatment for the management of MS. This trial is registered at ClinicalTrials.gov. Identifier: NCT03360487.",2020,"Investigate the effects of photobiomodulation (PBM) on the expression of IL-10 and nitrites in individuals with Relapsing-Remitting multiple sclerosis (MS), as these biomarkers play a fundamental role in the physiopathology of the disease.","['individuals with Relapsing-Remitting multiple sclerosis (MS', '14 individuals with a diagnosis of Relapsing-Remitting MS and a score of up to 6.0 on the Expanded Disability Status Scale (EDSS', 'individuals with relapsing-remitting multiple sclerosis']","['radial artery group (pre-treatment: 51 ± 16 nmol/mg protein; post-treatment: 42 ± 7 nmol/mg protein', 'photobiomodulation', 'photobiomodulation (PBM']","['expression of IL-10', 'Peripheral blood', 'interleukin-10 and nitrites', 'nitrite levels']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0751967', 'cui_str': 'Relapsing remitting multiple sclerosis'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0439600', 'cui_str': 'Remitting'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0451246', 'cui_str': 'Kurtzke multiple sclerosis rating scale'}]","[{'cui': 'C0162857', 'cui_str': 'Structure of radial artery'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439291', 'cui_str': 'mmol/kg'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0065764', 'cui_str': 'MBD protocol'}]","[{'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood'}, {'cui': 'C0028137', 'cui_str': 'Nitrite salt'}, {'cui': 'C0580333', 'cui_str': 'Urine nitrite'}]",14.0,0.0615259,"Investigate the effects of photobiomodulation (PBM) on the expression of IL-10 and nitrites in individuals with Relapsing-Remitting multiple sclerosis (MS), as these biomarkers play a fundamental role in the physiopathology of the disease.","[{'ForeName': 'Tamiris', 'Initials': 'T', 'LastName': 'Silva', 'Affiliation': 'Universidade Nove de Julho, UNINOVE, São Paulo, SP, Brazil.'}, {'ForeName': 'Yara Dadalti', 'Initials': 'YD', 'LastName': 'Fragoso', 'Affiliation': 'Universidade Metropolitana de Santos, UNIMES, Santos, SP, Brasil.'}, {'ForeName': 'Maria Fernanda Setúbal', 'Initials': 'MFS', 'LastName': 'Destro Rodrigues', 'Affiliation': 'Universidade Nove de Julho, UNINOVE, São Paulo, SP, Brazil.'}, {'ForeName': 'Andréa Oliver', 'Initials': 'AO', 'LastName': 'Gomes', 'Affiliation': 'Universidade Nove de Julho, UNINOVE, São Paulo, SP, Brazil.'}, {'ForeName': 'Fernanda Cordeiro', 'Initials': 'FC', 'LastName': 'da Silva', 'Affiliation': 'Universidade Nove de Julho, UNINOVE, São Paulo, SP, Brazil.'}, {'ForeName': 'Lucas', 'Initials': 'L', 'LastName': 'Andreo', 'Affiliation': 'Universidade Nove de Julho, UNINOVE, São Paulo, SP, Brazil.'}, {'ForeName': 'Ariane', 'Initials': 'A', 'LastName': 'Viana', 'Affiliation': 'Universidade Nove de Julho, UNINOVE, São Paulo, SP, Brazil.'}, {'ForeName': 'Daniela de Fátima', 'Initials': 'DF', 'LastName': 'Teixeira da Silva', 'Affiliation': 'Universidade Nove de Julho, UNINOVE, São Paulo, SP, Brazil.'}, {'ForeName': 'Maria Cristina', 'Initials': 'MC', 'LastName': 'Chavantes', 'Affiliation': 'Universidade Nove de Julho, UNINOVE, São Paulo, SP, Brazil.'}, {'ForeName': 'Anna Carolina Ratto', 'Initials': 'ACR', 'LastName': 'Tempestini Horliana', 'Affiliation': 'Universidade Nove de Julho, UNINOVE, São Paulo, SP, Brazil.'}, {'ForeName': 'Kátia', 'Initials': 'K', 'LastName': 'De Angelis', 'Affiliation': 'Universidade Nove de Julho, UNINOVE, São Paulo, SP, Brazil.'}, {'ForeName': 'Alessandro Melo', 'Initials': 'AM', 'LastName': 'Deana', 'Affiliation': 'Universidade Nove de Julho, UNINOVE, São Paulo, SP, Brazil.'}, {'ForeName': 'Luciana Prats', 'Initials': 'LP', 'LastName': 'Branco', 'Affiliation': 'Universidade Metropolitana de Santos, UNIMES, Santos, SP, Brasil.'}, {'ForeName': 'Kristianne Porta', 'Initials': 'KP', 'LastName': 'Santos Fernandes', 'Affiliation': 'Universidade Nove de Julho, UNINOVE, São Paulo, SP, Brazil.'}, {'ForeName': 'Lara Jansiski', 'Initials': 'LJ', 'LastName': 'Motta', 'Affiliation': 'Universidade Nove de Julho, UNINOVE, São Paulo, SP, Brazil.'}, {'ForeName': 'Raquel Agnelli', 'Initials': 'RA', 'LastName': 'Mesquita-Ferrari', 'Affiliation': 'Universidade Nove de Julho, UNINOVE, São Paulo, SP, Brazil.'}, {'ForeName': 'Sandra Kalil', 'Initials': 'SK', 'LastName': 'Bussadori', 'Affiliation': 'Universidade Nove de Julho, UNINOVE, São Paulo, SP, Brazil.'}]",PloS one,['10.1371/journal.pone.0230551'] 350,32243432,"Investigating the impact of early-life adversity on physiological, immune, and gene expression responses to acute stress: A pilot feasibility study.","OBJECTIVE Exposure to early-life adversity (ELA) can result in long-term changes to physiological systems, which predispose individuals to negative health outcomes. This biological embedding of stress-responsive systems may operate via dysregulation of physiological resources in response to common stressors. The present pilot study outlines a novel experimental design to test how young adults' exposure to ELA influences neuroendocrine and inflammatory responses to acute stress. MATERIALS AND METHODS Participants were 12 males (mean age = 21.25), half of whom endorsed at least three significant adverse events up to age 18 years ('ELA group'), and half who confirmed zero ('controls'). Using a randomized within-subjects, between-groups experimental design, we induced acute psychosocial stress (Trier Social Stress Test, TSST), and included a no-stress control condition one week apart. During these sessions, we obtained repeated measurements of physiological reactivity, gene expression of the glucocorticoid receptor (NR3C1), and plasma levels of pro-inflammatory cytokines (IL-1β, IL-6, IL-8 and TNFα) over a 4-hour window post-test. RESULTS In this pilot study, the ELA group evinced higher cortisol response and blunted NR3C1 gene expression in response to the TSST compared with controls, while no differences were observed in the no-stress condition. For pro-inflammatory cytokines, only IL-6 increased significantly in response to the TSST, with no differences between the two groups. CONCLUSION Overall, this pilot feasibility study provides a framework to investigate the biological embedding of early-adversity via dysregulation across physiological and genomic systems in response to acute psychosocial stress. ELA may program such systems in a maladaptive manner more likely to manifest during times of duress, predisposing individuals to the negative health consequences of everyday stressors. Future studies with larger sample size including both males and females are needed to replicate and expand upon these preliminary findings.",2020,"For pro-inflammatory cytokines, only IL-6 increased significantly in response to the TSST, with no differences between the two groups. ","['young adults', 'acute stress', ""Participants were 12 males (mean age = 21.25), half of whom endorsed at least three significant adverse events up to age 18 years ('ELA group'), and half who confirmed zero ('controls""]","['TSST', 'ELA']","['physiological reactivity, gene expression of the glucocorticoid receptor (NR3C1), and plasma levels of pro-inflammatory cytokines (IL-1β, IL-6, IL-8 and TNFα', 'cortisol response and blunted NR3C1 gene expression', 'acute psychosocial stress (Trier Social Stress Test, TSST']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0919414', 'cui_str': '0'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",[],"[{'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0034809', 'cui_str': 'Glucocorticoid receptor'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C1997138', 'cui_str': 'Blunted'}, {'cui': 'C1370369', 'cui_str': 'NR3C1 protein, human'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0065404', 'cui_str': 'lysyl-5-fluorotryptophyl-lysine'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}]",12.0,0.0355585,"For pro-inflammatory cytokines, only IL-6 increased significantly in response to the TSST, with no differences between the two groups. ","[{'ForeName': 'Idan', 'Initials': 'I', 'LastName': 'Shalev', 'Affiliation': 'Department of Biobehavioral Health, The Pennsylvania State University, University Park, PA, United States of America.'}, {'ForeName': 'Waylon J', 'Initials': 'WJ', 'LastName': 'Hastings', 'Affiliation': 'Department of Biobehavioral Health, The Pennsylvania State University, University Park, PA, United States of America.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Etzel', 'Affiliation': 'Department of Biobehavioral Health, The Pennsylvania State University, University Park, PA, United States of America.'}, {'ForeName': 'Salomon', 'Initials': 'S', 'LastName': 'Israel', 'Affiliation': 'Department of Psychology, The Hebrew University of Jerusalem, Jerusalem, Israel.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Russell', 'Affiliation': 'Department of Biobehavioral Health, The Pennsylvania State University, University Park, PA, United States of America.'}, {'ForeName': 'Kelsie A', 'Initials': 'KA', 'LastName': 'Hendrick', 'Affiliation': 'Department of Biobehavioral Health, The Pennsylvania State University, University Park, PA, United States of America.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Zinobile', 'Affiliation': 'Department of Biobehavioral Health, The Pennsylvania State University, University Park, PA, United States of America.'}, {'ForeName': 'Sue Rutherford', 'Initials': 'SR', 'LastName': 'Siegel', 'Affiliation': 'Department of Biobehavioral Health, The Pennsylvania State University, University Park, PA, United States of America.'}]",PloS one,['10.1371/journal.pone.0221310'] 351,32248760,The impact of a randomized dietary and physical activity intervention on chronic inflammation among obese African-American women.,"Lifestyle interventions may reduce inflammation and lower breast cancer (BrCa) risk. This randomized trial assessed the impact of the Sistas Inspiring Sistas Through Activity and Support (SISTAS) study on plasma C-reactive protein (CRP), interleukin-6 (IL-6) and Dietary Inflammatory Index (DII). This unblinded, dietary and physical activity trial was implemented in 337 obese (body mass index [BMI] ≥30 kg/m 2 ) African American (AA) women recruited between 2011 and 2015 in South Carolina through a community-based participatory approach with measurements at baseline, 3 months, and 12 months. Participants were randomized into either intervention (n = 176) or wait-list control group (n = 161). Linear mixed-effect models were used for analyses of CRP and IL-6. Baseline CRP was significantly higher in those with greater obesity, body fat percentage, and waist circumference (all p <.01). No difference was observed between groups for CRP or IL-6 at 3 or 12 months; however, improvements in diet were observed in the intervention group compared to the control group ( p  = .02) at 3 months but were not sustained at 12 months. Although the intervention was not successful at reducing levels of CRP or IL-6, a significant decrease was observed in DII score for the intervention group, indicating short-term positive dietary change.",2020,"No difference was observed between groups for CRP or IL-6 at 3 or 12 months; however, improvements in diet were observed in the intervention group compared to the control group ( p  = .02) at 3 months but were not sustained at 12 months.","['obese African-American women', '337 obese (body mass index [BMI] ≥30 kg/m 2 ) African American (AA) women recruited between 2011 and 2015 in South Carolina through a community-based participatory approach with measurements at baseline, 3\xa0months, and 12\xa0months']","['Lifestyle interventions', 'intervention (n\xa0=\xa0176) or wait-list control group', 'randomized dietary and physical activity intervention']","['Baseline CRP', 'levels of CRP or IL-6', 'chronic inflammation', 'inflammation and lower breast cancer (BrCa) risk', 'DII score', 'improvements in diet', 'CRP or IL-6', 'plasma C-reactive protein (CRP), interleukin-6 (IL-6) and Dietary Inflammatory Index (DII']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0037716', 'cui_str': 'South Carolina'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0021376', 'cui_str': 'Chronic inflammation'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0385506', 'cui_str': 'didodecylindocarbocyanine'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",,0.059447,"No difference was observed between groups for CRP or IL-6 at 3 or 12 months; however, improvements in diet were observed in the intervention group compared to the control group ( p  = .02) at 3 months but were not sustained at 12 months.","[{'ForeName': 'Oluwole Adeyemi', 'Initials': 'OA', 'LastName': 'Babatunde', 'Affiliation': 'Cancer Prevention and Control Program, University of South Carolina , Columbia, South Carolina, USA.'}, {'ForeName': 'Swann', 'Initials': 'S', 'LastName': 'Arp Adams', 'Affiliation': 'Cancer Prevention and Control Program, University of South Carolina , Columbia, South Carolina, USA.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Truman', 'Affiliation': 'Department of Epidemiology and Biostatistics, Arnold School of Public Health, University of South Carolina , Columbia, South Carolina, USA.'}, {'ForeName': 'Erica', 'Initials': 'E', 'LastName': 'Sercy', 'Affiliation': 'Cancer Prevention and Control Program, University of South Carolina , Columbia, South Carolina, USA.'}, {'ForeName': 'Angela E', 'Initials': 'AE', 'LastName': 'Murphy', 'Affiliation': 'Department of Pathology, Microbiology and Immunology, School of Medicine, University of South Carolina , Columbia, South Carolina, USA.'}, {'ForeName': 'Samira', 'Initials': 'S', 'LastName': 'Khan', 'Affiliation': 'Cancer Prevention and Control Program, University of South Carolina , Columbia, South Carolina, USA.'}, {'ForeName': 'Thomas G', 'Initials': 'TG', 'LastName': 'Hurley', 'Affiliation': 'Cancer Prevention and Control Program, University of South Carolina , Columbia, South Carolina, USA.'}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Wirth', 'Affiliation': 'Cancer Prevention and Control Program, University of South Carolina , Columbia, South Carolina, USA.'}, {'ForeName': 'Seul Ki', 'Initials': 'SK', 'LastName': 'Choi', 'Affiliation': 'Cancer Prevention and Control Program, University of South Carolina , Columbia, South Carolina, USA.'}, {'ForeName': 'Hiluv', 'Initials': 'H', 'LastName': 'Johnson', 'Affiliation': 'Cancer Prevention and Control Program, University of South Carolina , Columbia, South Carolina, USA.'}, {'ForeName': 'James R', 'Initials': 'JR', 'LastName': 'Hebert', 'Affiliation': 'Cancer Prevention and Control Program, University of South Carolina , Columbia, South Carolina, USA.'}]",Women & health,['10.1080/03630242.2020.1746950'] 352,31900761,Expressive writing intervention for posttraumatic stress disorder among Chinese American breast cancer survivors: the moderating role of social constraints.,"PURPOSE Posttraumatic stress disorder (PTSD) is a significant condition among breast cancer survivors (BCSs). However, few intervention studies for cancer-related PTSD were conducted among Asian cancer survivors. We evaluated a culturally sensitive expressive writing intervention, which combined cognitive reappraisal and emotional disclosure, in reducing PTSD among Chinese American BCSs. We also tested social constraints (defined as social conditions when individuals feel misunderstood or alienated when they desire to disclose their thoughts and feelings) as a moderator. METHODS Chinese American BCSs (n = 136) were randomly assigned to three groups with assigned writing topics for 3 weeks: a self-regulation group, which wrote about the deepest feelings related to cancer in week 1, cognitive reappraisal about stress and coping in week 2, and benefit finding in week 3; an enhanced self-regulation group, with the same instructions, except weeks 1 and 2 were reversed; and a cancer-fact group, which wrote about cancer experiences objectively for 3 weeks. PTSD symptoms were measured at baseline and 1-, 3-, and 6-month follow-ups. Social constraints were measured at baseline. RESULTS Both the self-regulation and enhanced self-regulation groups showed reduced PTSD symptoms compared to the cancer-fact group. For reexperiencing and hyperarousal symptoms, expressive writing was more effective for BCSs who experienced high vs. low levels of social constraints; the opposite was found for avoidance symptoms. CONCLUSION Findings demonstrated the effectiveness of expressive writing intervention in reducing PTSD for this minority population, and that the moderating role of survivors' social network varies among different PTSD symptom clusters. ClinicalTrials.gov Identifier: NCT02946619.",2020,"We evaluated a culturally sensitive expressive writing intervention, which combined cognitive reappraisal and emotional disclosure, in reducing PTSD among Chinese American BCSs.","['Chinese American breast cancer survivors', 'breast cancer survivors (BCSs', 'Chinese American BCSs (n\u2009=\u2009136']","['culturally sensitive expressive writing intervention, which combined cognitive reappraisal and emotional disclosure', 'Expressive writing intervention', 'self-regulation group, which wrote about the deepest feelings related to cancer in week 1, cognitive reappraisal about stress and coping in week 2, and benefit finding in week 3; an enhanced self-regulation group, with the same instructions, except weeks 1 and 2 were reversed; and a cancer-fact group, which wrote about cancer experiences objectively for 3\xa0weeks', 'expressive writing intervention']","['PTSD symptoms', 'Social constraints']","[{'cui': 'C0008121', 'cui_str': 'Chinese Americans'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C4517568', 'cui_str': 'One hundred and thirty-six'}]","[{'cui': 'C0332324', 'cui_str': 'Sensitive (qualifier value)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0012625', 'cui_str': 'Information Disclosure'}, {'cui': 'C0684274', 'cui_str': 'Self Regulation'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C2607943', 'cui_str': 'findings'}, {'cui': 'C0039401', 'cui_str': 'Teaching'}]","[{'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",,0.0173267,"We evaluated a culturally sensitive expressive writing intervention, which combined cognitive reappraisal and emotional disclosure, in reducing PTSD among Chinese American BCSs.","[{'ForeName': 'Qiao', 'Initials': 'Q', 'LastName': 'Chu', 'Affiliation': 'School of Public Health, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Ivan H C', 'Initials': 'IHC', 'LastName': 'Wu', 'Affiliation': 'Department of Health Disparities Research, The University of Texas MD Anderson Cancer Center, 1400 Pressler St., Houston, TX, 77030, USA.'}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Lu', 'Affiliation': 'Department of Health Disparities Research, The University of Texas MD Anderson Cancer Center, 1400 Pressler St., Houston, TX, 77030, USA. qlu@mdanderson.org.'}]","Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation",['10.1007/s11136-019-02385-5'] 353,31136202,Heat therapy improves glucose tolerance and adipose tissue insulin signaling in polycystic ovary syndrome.,"Polycystic ovary syndrome (PCOS) is associated with high rates of obesity and metabolic dysfunction. Repeated passive heat exposure (termed heat therapy) is a novel lifestyle intervention for improving health in obese women with PCOS. The purpose of this study was to examine changes in metabolic function in obese women with PCOS following heat therapy. Eighteen age- and BMI-matched obese women with PCOS (age: 27 ± 1 yr, BMI: 41.3 ± 1.1 kg/m -2 ) were assigned to heat therapy (HT) or time control (CON). HT participants underwent 30 one-hour hot tub sessions over 8-10 wk, while CON participants completed all testing but did not undergo heat therapy. Before (Pre), at the mid-point (Mid), and following (Post) 8-10 wk of heat therapy, metabolic health was assessed using a 2-h oral glucose tolerance test, a subcutaneous abdominal fat biopsy (Pre-Post only), and other blood markers relating to metabolic function. HT participants exhibited improved fasting glucose (Pre: 105 ± 3, Post: 89 ± 5mg/dl; P = 0.001), glucose area under the curve (AUC) (Pre: 18,698 ± 1,045, Post: 16,987 ± 1,017 mg·dl -1 ·min -1 ; P = 0.028) and insulin AUC (Pre: 126,924 ± 11,730, Post: 91,233 ± 14,429 IU l -1 ·min -1 ; P = 0.012). Adipocyte insulin signaling (p-AKT at Ser-473 with 1.2 nM insulin) increased in HT (Pre: 0.29 ± 0.14, Post: 0.93 ± 0.29 AU; P = 0.021). Additionally, serum testosterone declined in HT participants (Pre: 51 ± 7, Post: 34 ± 4 ng/dl; P = 0.033). No parameters changed over time in CON, and no change in BMI was observed in either group. HT substantially improved metabolic risk profile in obese women with PCOS. HT also reduced androgen excess and may improve PCOS symptomology.",2019,"Adipocyte insulin signaling (p-AKT at Ser-473 with 1.2 nM insulin) increased in HT (Pre: 0.29 ± 0.14, Post: 0.93 ± 0.29 AU; P = 0.021).","['obese women with PCOS', 'obese women with PCOS following heat therapy', 'polycystic ovary syndrome', 'Polycystic ovary syndrome (PCOS', 'Eighteen age- and BMI-matched obese women with PCOS (age: 27\u2009±']","['Repeated passive heat exposure (termed heat therapy', 'Heat therapy', 'heat therapy (HT) or time control (CON', 'HT']","['metabolic function', 'serum testosterone', 'BMI', 'metabolic risk profile', 'fasting glucose', 'Adipocyte insulin signaling', 'PCOS symptomology', 'glucose area under the curve (AUC', 'time in CON', 'glucose tolerance and adipose tissue insulin signaling']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0150611', 'cui_str': 'Heat therapy (procedure)'}, {'cui': 'C0032460', 'cui_str': 'Sclerocystic Ovary Syndrome'}, {'cui': 'C3715206', 'cui_str': 'Eighteen'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0336766', 'cui_str': 'Matches'}]","[{'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C0239930', 'cui_str': 'Exposure to heat (event)'}, {'cui': 'C0150611', 'cui_str': 'Heat therapy (procedure)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0428413', 'cui_str': 'Serum testosterone measurement'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0206131', 'cui_str': 'Fat Cells'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0231197', 'cui_str': 'Tolerance, function (observable entity)'}, {'cui': 'C0001527', 'cui_str': 'Fatty Tissue'}]",,0.0948154,"Adipocyte insulin signaling (p-AKT at Ser-473 with 1.2 nM insulin) increased in HT (Pre: 0.29 ± 0.14, Post: 0.93 ± 0.29 AU; P = 0.021).","[{'ForeName': 'Brett R', 'Initials': 'BR', 'LastName': 'Ely', 'Affiliation': 'Department of Human Physiology, University of Oregon , Eugene, Oregon.'}, {'ForeName': 'Zachary S', 'Initials': 'ZS', 'LastName': 'Clayton', 'Affiliation': 'Department of Human Physiology, University of Oregon , Eugene, Oregon.'}, {'ForeName': 'Carrie E', 'Initials': 'CE', 'LastName': 'McCurdy', 'Affiliation': 'Department of Human Physiology, University of Oregon , Eugene, Oregon.'}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Pfeiffer', 'Affiliation': 'PeaceHealth Medical Group, Oregon Bariatric Center , Springfield, Oregon.'}, {'ForeName': 'Karen Wiedenfeld', 'Initials': 'KW', 'LastName': 'Needham', 'Affiliation': 'Department of Human Physiology, University of Oregon , Eugene, Oregon.'}, {'ForeName': 'Lindan N', 'Initials': 'LN', 'LastName': 'Comrada', 'Affiliation': 'Department of Human Physiology, University of Oregon , Eugene, Oregon.'}, {'ForeName': 'Christopher T', 'Initials': 'CT', 'LastName': 'Minson', 'Affiliation': 'Department of Human Physiology, University of Oregon , Eugene, Oregon.'}]",American journal of physiology. Endocrinology and metabolism,['10.1152/ajpendo.00549.2018'] 354,30974986,Efficacy and Safety of Degludec Compared to Glargine 300 Units/mL in Insulin-Experienced Patients With Type 2 Diabetes: Trial Protocol Amendment (NCT03078478).,"BACKGROUND A head-to-head trial (NCT03078478) between insulin degludec and insulin glargine U300 with the primary objective of comparing the risk of hypoglycemia is being conducted. During trial conduct, safety concerns related to the glycemic data collection system led to a postinitiation protocol amendment, described here. METHODS This randomized (1:1), open-label, treat-to-target, multinational trial was initiated in March 2017 with a planned treatment period of 52 weeks (16 weeks titration + 36 weeks maintenance). Overall, ~1600 insulin-experienced patients at risk of developing hypoglycemia based on predefined risk factors were included. The protocol amendment implemented in February 2018 resulted in assuring patient safety and an extension of the total treatment period up to 88 weeks (16 weeks titration + variable maintenance 1 + 36 weeks maintenance 2). The original glycemic data collection system (MyGlucoHealth blood glucose meter + electronic diary) was discontinued because of safety concerns and replaced with an Abbott blood glucose meter and paper diary to collect self-measured blood glucose and hypoglycemic episodes. The primary endpoint of number of severe or blood-glucose confirmed symptomatic hypoglycemic episodes will be evaluated with the same analysis duration and statistical methods as the original protocol. Only relevant changes were implemented to maintain patient safety while permitting evaluation of the scientific objectives of the trial. CONCLUSIONS These observations highlight the importance of safety surveillance during trial conduct despite the use of currently marketed glucose monitoring devices. The prompt protocol amendment and ensuing actions ensured that the scientific integrity of the trial was not compromised.",2019,The original glycemic data collection system (MyGlucoHealth blood glucose meter + electronic diary) was discontinued because of safety concerns and replaced with an Abbott blood glucose meter and paper diary to collect self-measured blood glucose and hypoglycemic episodes.,['Insulin-Experienced Patients With Type 2 Diabetes'],"['Glargine 300 Units/mL', 'titration + variable maintenance 1 ']","['Efficacy and Safety', 'Abbott blood glucose meter and paper diary to collect self-measured blood glucose and hypoglycemic episodes', 'number of severe or blood-glucose confirmed symptomatic hypoglycemic episodes']","[{'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C2945590', 'cui_str': 'unit/mL'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0472226', 'cui_str': 'Blood glucose meters (physical object)'}, {'cui': 'C0030351', 'cui_str': 'Paper'}, {'cui': 'C0376660', 'cui_str': 'Diary'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C0745153', 'cui_str': 'Hypoglycemic attack'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}]",,0.0951741,The original glycemic data collection system (MyGlucoHealth blood glucose meter + electronic diary) was discontinued because of safety concerns and replaced with an Abbott blood glucose meter and paper diary to collect self-measured blood glucose and hypoglycemic episodes.,"[{'ForeName': 'Athena', 'Initials': 'A', 'LastName': 'Philis-Tsimikas', 'Affiliation': '1 Scripps Whittier Diabetes Institute, La Jolla, CA, USA.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Stratton', 'Affiliation': '2 Gloucestershire Retinal Research Group, Cheltenham General Hospital, Gloucestershire, UK.'}, {'ForeName': 'Lone', 'Initials': 'L', 'LastName': 'Nørgård Troelsen', 'Affiliation': '3 Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Britta', 'Initials': 'B', 'LastName': 'Anker Bak', 'Affiliation': '3 Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Lawrence A', 'Initials': 'LA', 'LastName': 'Leiter', 'Affiliation': ""4 Li Ka Shing Knowledge Institute, Division of Endocrinology and Metabolism, St Michael's Hospital, University of Toronto, Toronto, Canada.""}]",Journal of diabetes science and technology,['10.1177/1932296819841585'] 355,32240228,Randomized pilot trial for the efficacy of the MMF07 foot massager and heat therapy for restless legs syndrome.,"BACKGROUND Restless Legs Syndrome (RLS) is a sensorimotor condition with a wide range of severity. Symptoms negatively affect sleep and quality of life. Pharmacologic options are not universally effective and side effects are common. Objective data regarding non-pharmacologic treatment is limited. The study objective was to evaluate the efficacy of the MMF07 foot massager and heat therapy on the severity of RLS symptoms. METHODS In this pilot randomized controlled trial, twenty-eight patients with diagnosed, bothersome RLS were randomized to four treatment arms: no active intervention (n = 7), foot massager (n = 8), heat therapy (n = 6), and foot massager plus heat therapy (n = 7). Participants completed the RLS Severity Scale, RLS Quality of Life questionnaire, and the Medical Outcomes Study Sleep scale at the baseline visit and at the 4-week follow up visit. RESULTS Four weeks post randomization, participants in the massager group had significant improvement in the RLS severity score (average difference: -9.0, 95% CI: -16.3, -1.7, p = 0.017) and sleep scale (average difference: -22.0, 95% CI: -36.5, -7.5, p = 0.005) compared to the no intervention group. The heat alone group had a significant improvement in the sleep scale compared to the no-intervention group (average difference: -17.4, 95% CI: -32.5, -2.3, p = 0.026). Quality of life improved in the massage only group compared to control (average difference 25.3, 95% CI: -2.4, 53.0, p = 0.072). CONCLUSIONS Results suggest that the MMF07 foot massage device and heat therapy may be feasible and effective treatment options to improve RSL symptoms.",2020,"Quality of life improved in the massage only group compared to control (average difference 25.3, 95% CI: -2.4, 53.0, p = 0.072). ","['restless legs syndrome', 'twenty-eight patients with diagnosed, bothersome RLS']","['MMF07 foot massager and heat therapy', 'foot massager (n = 8), heat therapy (n = 6), and foot massager plus heat therapy', 'no active intervention']","['sleep scale', 'RSL symptoms', 'sleep and quality of life', 'RLS Severity Scale, RLS Quality of Life questionnaire, and the Medical Outcomes Study Sleep scale', 'Quality of life', 'RLS severity score']","[{'cui': 'C0035258', 'cui_str': 'Restless legs'}, {'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0020548', 'cui_str': 'Thermotherapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0035258', 'cui_str': 'Restless legs'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0543472', 'cui_str': 'Outcome Studies'}, {'cui': 'C0457451', 'cui_str': 'Severity score'}]",28.0,0.104081,"Quality of life improved in the massage only group compared to control (average difference 25.3, 95% CI: -2.4, 53.0, p = 0.072). ","[{'ForeName': 'Ariane', 'Initials': 'A', 'LastName': 'Park', 'Affiliation': ""Department of Neurology, Madden Center for Parkinson's Disease and Related Disorders, The Ohio State University Wexner Medical Center, Columbus, Ohio, United States of America.""}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Ambrogi', 'Affiliation': ""Department of Neurology, Madden Center for Parkinson's Disease and Related Disorders, The Ohio State University Wexner Medical Center, Columbus, Ohio, United States of America.""}, {'ForeName': 'Erinn M', 'Initials': 'EM', 'LastName': 'Hade', 'Affiliation': 'Department of Biomedical Informatics, Center for Biostatistics, The Ohio State University Wexner Medical Center, Columbus, Ohio, United States of America.'}]",PloS one,['10.1371/journal.pone.0230951'] 356,32271718,Exebacase for patients with Staphylococcus aureus bloodstream infection and endocarditis.,"BACKGROUNDNovel therapeutic approaches are critically needed for Staphylococcus aureus bloodstream infections (BSIs), particularly for methicillin-resistant S. aureus (MRSA). Exebacase, a first-in-class antistaphylococcal lysin, is a direct lytic agent that is rapidly bacteriolytic, eradicates biofilms, and synergizes with antibiotics.METHODSIn this superiority-design study, we randomly assigned 121 patients with S. aureus BSI/endocarditis to receive a single dose of exebacase or placebo. All patients received standard-of-care antibiotics. The primary efficacy endpoint was clinical outcome (responder rate) on day 14.RESULTSClinical responder rates on day 14 were 70.4% and 60.0% in the exebacase + antibiotics and antibiotics-alone groups, respectively (difference = 10.4, 90% CI [-6.3, 27.2], P = 0.31), and were 42.8 percentage points higher in the prespecified exploratory MRSA subgroup (74.1% vs. 31.3%, difference = 42.8, 90% CI [14.3, 71.4], ad hoc P = 0.01). Rates of adverse events (AEs) were similar in both groups. No AEs of hypersensitivity to exebacase were reported. Thirty-day all-cause mortality rates were 9.7% and 12.8% in the exebacase + antibiotics and antibiotics-alone groups, respectively, with a notable difference in MRSA patients (3.7% vs. 25.0%, difference = -21.3, 90% CI [-45.1, 2.5], ad hoc P = 0.06). Among MRSA patients in the United States, median length of stay was 4 days shorter and 30-day hospital readmission rates were 48% lower in the exebacase-treated group compared with antibiotics alone.CONCLUSIONThis study establishes proof of concept for exebacase and direct lytic agents as potential therapeutics and supports conduct of a confirmatory study focused on exebacase to treat MRSA BSIs.TRIAL REGISTRATIONClinicaltrials.gov NCT03163446.FUNDINGContraFect Corporation.",2020,"Thirty-day all-cause mortality rates were 9.7% and 12.8% in the exebacase + antibiotics and antibiotics alone groups, respectively, with a notable difference in MRSA (3.7% vs. 25.0%, difference= -21.3, 90% CI [-45.1, 2.5], ad hoc p-value=0.06).",['121 patients with S. aureus BSI/endocarditis to receive a single dose of'],"['MRSA', 'standard-of-care antibiotics', 'exebacase or placebo']","['30-day hospital readmission rates', 'Rates of adverse events (AEs', 'median length-of-stay', 'MRSA', 'mortality rates', 'clinical outcome (responder rate) at Day 14.RESULTSClinical responder rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038172', 'cui_str': 'Staphylococcus aureus'}, {'cui': 'C2316160', 'cui_str': 'Infection of bloodstream'}, {'cui': 'C0014118', 'cui_str': 'Endocarditis'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]","[{'cui': 'C1955827', 'cui_str': 'Methicillin-Resistant'}, {'cui': 'C0038172', 'cui_str': 'Staphylococcus aureus'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0587438', 'cui_str': 'Day hospital'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C1955827', 'cui_str': 'Methicillin-Resistant'}, {'cui': 'C0038172', 'cui_str': 'Staphylococcus aureus'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",121.0,0.153962,"Thirty-day all-cause mortality rates were 9.7% and 12.8% in the exebacase + antibiotics and antibiotics alone groups, respectively, with a notable difference in MRSA (3.7% vs. 25.0%, difference= -21.3, 90% CI [-45.1, 2.5], ad hoc p-value=0.06).","[{'ForeName': 'Vance G', 'Initials': 'VG', 'LastName': 'Fowler', 'Affiliation': 'Duke University Medical Center, Durham, North Carolina, USA.'}, {'ForeName': 'Anita F', 'Initials': 'AF', 'LastName': 'Das', 'Affiliation': 'AD Stat Consulting, Guerneville, California, USA.'}, {'ForeName': 'Joy', 'Initials': 'J', 'LastName': 'Lipka-Diamond', 'Affiliation': 'Lipka Consulting, Mullica Hill, New Jersey, USA.'}, {'ForeName': 'Raymond', 'Initials': 'R', 'LastName': 'Schuch', 'Affiliation': 'ContraFect Corporation, Yonkers, New York, USA.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Pomerantz', 'Affiliation': 'ContraFect Corporation, Yonkers, New York, USA.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Jáuregui-Peredo', 'Affiliation': 'Mercy Health-St. Vincent Medical Center, Toledo, Ohio, USA.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Bressler', 'Affiliation': 'Infectious Disease Specialists of Atlanta, Georgia, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Evans', 'Affiliation': 'The Ohio State University, Columbus, Ohio, USA.'}, {'ForeName': 'Gregory J', 'Initials': 'GJ', 'LastName': 'Moran', 'Affiliation': 'Olive View-UCLA Medical Center, Sylmar, California, USA.'}, {'ForeName': 'Mark E', 'Initials': 'ME', 'LastName': 'Rupp', 'Affiliation': 'University of Nebraska Medical Center, Omaha, Nebraska, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Wise', 'Affiliation': 'Johns Hopkins Bayview Medical Center, Baltimore, Maryland, USA.'}, {'ForeName': 'G Ralph', 'Initials': 'GR', 'LastName': 'Corey', 'Affiliation': 'Duke University Medical Center, Durham, North Carolina, USA.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Zervos', 'Affiliation': 'Henry Ford Health System, Detroit, Michigan, USA.'}, {'ForeName': 'Pamela S', 'Initials': 'PS', 'LastName': 'Douglas', 'Affiliation': 'Duke University Medical Center, Durham, North Carolina, USA.'}, {'ForeName': 'Cara', 'Initials': 'C', 'LastName': 'Cassino', 'Affiliation': 'ContraFect Corporation, Yonkers, New York, USA.'}]",The Journal of clinical investigation,['10.1172/JCI136577'] 357,32271919,Bioavailable Methionine Assessed Using the Indicator Amino Acid Oxidation Method Is Greater When Cooked Chickpeas and Steamed Rice Are Combined in Healthy Young Men.,"BACKGROUND In general, pulse protein is limiting in the indispensable amino acid methionine, and antinutritional factors in pulses can affect methionine bioavailability. Complementation with grains such as rice can improve pulse protein quality, but knowledge of methionine bioavailability in pulses and grains is necessary to correct for available methionine when planning and assessing dietary protein intake. OBJECTIVES The study objectives were to determine the bioavailability of methionine in rice and chickpeas separately and to assess the effect of complementation of chickpeas and rice. METHODS Eleven healthy young men (<30 y, BMI <25 kg/m2) were studied in a repeated-measures design using the indicator amino acid oxidation (IAAO) method, with l-[1-13C]phenylalanine as the indicator. Each received 7 or 10 methionine intakes in random order: 4 intakes of l-methionine-0.5, 1, 2, and 3 mg⋅kg-1⋅d-1 (reference diet); 3 intakes of methionine from rice and from chickpeas; and 3 intakes from the mixed meal of chickpeas plus rice (test diets). The bioavailability of methionine and the effect of complementation were assessed by comparing the IAAO response to varying intakes of methionine in rice, in cooked Canadian chickpeas, and in rice plus chickpeas combined compared with the IAAO response to l-methionine intakes in the reference protein (crystalline amino acid mixture patterned after egg protein) using the slope ratio method. RESULTS The bioavailability of methionine from rice and from chickpeas was 100% and 63%, respectively. Complementation of cooked chickpeas with rice decreased the oxidation of l-[1-13C]phenylalanine by up to 14% (P < 0.05), suggesting an improved protein quality of the combined chickpeas plus rice protein. CONCLUSIONS When chickpeas are the main protein source in the diet of young adult men, the combination of rice and chickpeas in a 3:1 ratio is recommended to improve dietary protein quality. This trial was registered at clinicaltrials.gov as NCT03339154 and NCT03674736.",2020,"Complementation of cooked chickpeas with rice decreased the oxidation of l-[1-13C]phenylalanine by up to 14% (P < 0.05), suggesting an improved protein quality of the combined chickpeas plus rice protein. ","['young adult men', 'Eleven healthy young men (<30 y, BMI <25 kg/m2', 'Healthy Young Men']","['Cooked Chickpeas and Steamed Rice', '10 methionine intakes in random order: 4 intakes of l-methionine-0.5, 1, 2, and 3 mg⋅kg-1⋅d-1 (reference diet); 3 intakes of methionine from rice and from chickpeas; and 3 intakes from the mixed meal of chickpeas plus rice (test diets', 'indicator amino acid oxidation (IAAO) method, with l-[1-13C]phenylalanine', 'Bioavailable Methionine']","['oxidation of l-[1-13C]phenylalanine', 'bioavailability of methionine', 'protein quality', 'pulse protein quality']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}]","[{'cui': 'C0335326', 'cui_str': 'Cookery'}, {'cui': 'C0950052', 'cui_str': 'Chick peas'}, {'cui': 'C0038225', 'cui_str': 'Steam'}, {'cui': 'C0035567', 'cui_str': 'Rice'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C4284072', 'cui_str': 'Order document'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0452401', 'cui_str': 'Test diet'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0002520', 'cui_str': 'amino acids'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0935763', 'cui_str': 'Bioavailable'}]","[{'cui': 'C0030011', 'cui_str': 'Oxidation'}, {'cui': 'C0005508', 'cui_str': 'Availability, Biological'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0034107', 'cui_str': 'Pulse taking'}]",11.0,0.0349997,"Complementation of cooked chickpeas with rice decreased the oxidation of l-[1-13C]phenylalanine by up to 14% (P < 0.05), suggesting an improved protein quality of the combined chickpeas plus rice protein. ","[{'ForeName': 'Mahroukh', 'Initials': 'M', 'LastName': 'Rafii', 'Affiliation': 'Research Institute, Hospital for Sick Children, Toronto, Ontario, Canada.'}, {'ForeName': 'Paul B', 'Initials': 'PB', 'LastName': 'Pencharz', 'Affiliation': 'Research Institute, Hospital for Sick Children, Toronto, Ontario, Canada.'}, {'ForeName': 'Ronald O', 'Initials': 'RO', 'LastName': 'Ball', 'Affiliation': 'Department of Nutritional Sciences, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Tomlinson', 'Affiliation': 'Research Institute, Hospital for Sick Children, Toronto, Ontario, Canada.'}, {'ForeName': 'Rajavel', 'Initials': 'R', 'LastName': 'Elango', 'Affiliation': 'Department of Pediatrics, School of Population and Public Health, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Glenda', 'Initials': 'G', 'LastName': 'Courtney-Martin', 'Affiliation': 'Research Institute, Hospital for Sick Children, Toronto, Ontario, Canada.'}]",The Journal of nutrition,['10.1093/jn/nxaa086'] 358,32100192,InRange: Comparison of the Second-Generation Basal Insulin Analogues Glargine 300 U/mL and Degludec 100 U/mL in Persons with Type 1 Diabetes Using Continuous Glucose Monitoring-Study Design.,"INTRODUCTION Suboptimal glycaemic control among people with type 1 diabetes (T1D) is known to lead to long-term micro- and macrovascular complications and, unfortunately, it is still prevalent even in the most affluent societies. Although glycated haemoglobin monitoring is considered to be the gold standard for assessing glycaemic control, such monitoring is unable to reliably measure acute glycaemic excursions. Continuous glucose monitoring (CGM) has been shown to improve glucose control and reduce the incidence of hypoglycaemia, and also allow a more complete assessment of overall glycaemic control and hyper- and hypoglycaemic excursions. The use of CGM has led to time-in-range, which is the time that a patient is within the glycaemic range of 70 to 180 mg/dL, to be adopted as a treatment target. To date, only limited data comparing the second-generation insulins glargine 300 U/mL (Gla-300) and degludec 100 U/mL (IDeg-100) in people with T1D are available, and there is no CGM literature on comparisons of the use of CGM results to assess primary, secondary and tertiary endpoints. The aim of the InRange study was to address this unmet need. METHODS InRange is a multicentre, randomised, active-controlled, parallel-group, 12-week, open-label, phase 4, comparative study. Adults with T1D will be randomised to receive once-daily Gla-300 or IDeg-100 by subcutaneous injection in the morning. Following an 8-week titration period, CGM data will be collected over 20 consecutive days. PLANNED OUTCOMES The primary objective is to demonstrate that Gla-300 is noninferior to IDeg-100 in terms of glycaemic control [time-in-range ≥ 70 to ≤ 180 mg/dL (≥ 3.9 to ≤ 10 mmol/L)] and variability, as assessed using CGM, in adults with T1D. The results are expected to help confirm the utility of CGM in clinical practice in this population and provide insight into its application as an outcome measure in clinical practice. TRIAL REGISTRATION NCT04075513.",2020,"Continuous glucose monitoring (CGM) has been shown to improve glucose control and reduce the incidence of hypoglycaemia, and also allow a more complete assessment of overall glycaemic control and hyper- and hypoglycaemic excursions.","['Adults with T1D', 'adults with T1D', 'Persons with Type 1 Diabetes Using Continuous Glucose Monitoring-Study Design', 'people with type 1 diabetes (T1D']","['CGM', 'Gla-300', 'U/mL', 'Second-Generation Basal Insulin Analogues Glargine 300 U/mL and Degludec 100 U/mL', 'Continuous glucose monitoring (CGM']",[],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C4523945', 'cui_str': 'Continuous glucose monitoring'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C2945590', 'cui_str': 'unit/mL'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C0205112', 'cui_str': 'Basal (qualifier value)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C3491971', 'cui_str': 'insulin degludec'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C4523945', 'cui_str': 'Continuous glucose monitoring'}]",[],,0.065702,"Continuous glucose monitoring (CGM) has been shown to improve glucose control and reduce the incidence of hypoglycaemia, and also allow a more complete assessment of overall glycaemic control and hyper- and hypoglycaemic excursions.","[{'ForeName': 'Tadej', 'Initials': 'T', 'LastName': 'Battelino', 'Affiliation': ""UMC-University Children's Hospital, Faculty of Medicine, University of Ljubljana, Ljubljana, Slovenia. tadej.battelino@mf.uni-lj.si.""}, {'ForeName': 'Zsolt', 'Initials': 'Z', 'LastName': 'Bosnyak', 'Affiliation': 'Sanofi S.A., Paris, France.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Danne', 'Affiliation': 'Diabetes Centre for Children and Adolescents, Children\'s and Youth Hospital ""Auf Der Bult"", Hannover, Germany.'}, {'ForeName': 'Bhaswati', 'Initials': 'B', 'LastName': 'Mukherjee', 'Affiliation': 'Sanofi S.A., Paris, France.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Edelman', 'Affiliation': 'University of California, San Diego, CA, USA.'}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Pilorget', 'Affiliation': 'Sanofi S.A., Paris, France.'}, {'ForeName': 'Pratik', 'Initials': 'P', 'LastName': 'Choudhary', 'Affiliation': ""King's College Hospital NHS Foundation Trust, London, UK.""}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Renard', 'Affiliation': 'Department of Endocrinology, Diabetes and Nutrition, Montpellier University Hospital, University of Montpellier, Montpellier, France.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Bergenstal', 'Affiliation': 'International Diabetes Center at Park Nicollet, Minneapolis, USA.'}]","Diabetes therapy : research, treatment and education of diabetes and related disorders",['10.1007/s13300-020-00781-6'] 359,31641887,Effects of sitagliptin on exercise capacity and hemodynamics in patients with type 2 diabetes mellitus and coronary artery disease.,"Sitagliptin attenuates left ventricular (LV) dysfunction and may improve oxygen uptake in animals. The effects of sitagliptin on oxygen uptake (VO 2 ) and exercise hemodynamics have been unclear in patients with type 2 diabetes mellitus (T2DM) and coronary artery disease (CAD). Thirty patients with T2DM and CAD were randomized into a sitagliptin (50 mg/day) or voglibose (0.6 mg/day) group. Patients underwent maximal cardiopulmonary exercise testing. VO 2 and hemodynamics were evaluated at rest, anaerobic threshold and peak exercise. Resting LV diastolic function (E', peak early diastolic mitral annular velocity) and geometry were evaluated by echocardiography, and endothelial function by reactive hyperemia peripheral arterial tonometry. A total of 24 patients (69 ± 9 years) completed 6 months of intervention. Peak VO 2 in the sitagliptin and voglibose groups (25.3 ± 7.3 vs. 24.0 ± 7.4, 22.7 ± 4.8 vs. 22.1 ± 5.2 ml/kg/min) was slightly decreased after 6 months (time effect p = 0.051; group × time effect p = 0.49). No effects were observed on LV ejection fraction, E', or reactive hyperemia index in either group. Heart rate during exercise was unaffected in both groups. Systolic blood pressure was unchanged by sitagliptin at rest and during exercise, but slightly lowered by voglibose at anaerobic threshold and peak exercise. In patients with T2DM and CAD, sitagliptin had little effect on resting LV and arterial function, exercise capacity, or exercise hemodynamics. Further studies need to be conducted with more patients as the number of the patients in this study was limited.",2020,"No effects were observed on LV ejection fraction, E', or reactive hyperemia index in either group.","['24 patients (69\u2009±\u20099 years) completed 6 months of intervention', 'animals', 'Thirty patients with T2DM and CAD', 'patients with type 2 diabetes mellitus (T2DM) and coronary artery disease (CAD', 'patients with type 2 diabetes mellitus and coronary artery disease']","['voglibose', 'sitagliptin', 'maximal cardiopulmonary exercise testing']","['Heart rate during exercise', 'Sitagliptin attenuates left ventricular (LV) dysfunction', 'resting LV and arterial function, exercise capacity, or exercise hemodynamics', 'exercise capacity and hemodynamics', 'Systolic blood pressure', 'oxygen uptake', 'VO 2 and hemodynamics', ""Resting LV diastolic function (E', peak early diastolic mitral annular velocity) and geometry were evaluated by echocardiography, and endothelial function by reactive hyperemia peripheral arterial tonometry"", 'Peak VO 2', ""LV ejection fraction, E', or reactive hyperemia index""]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0003062', 'cui_str': 'Animals'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}]","[{'cui': 'C0532578', 'cui_str': '3,4-dideoxy-4-((2-hydroxy-1-(hydroxymethyl)ethyl)amino)-2-C-(hydroxymethyl)-D-epi-inositol'}, {'cui': 'C1565750', 'cui_str': 'sitagliptin'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0587107', 'cui_str': 'During exercise (qualifier value)'}, {'cui': 'C1565750', 'cui_str': 'sitagliptin'}, {'cui': 'C0332161', 'cui_str': 'Attenuated by (contextual qualifier) (qualifier value)'}, {'cui': 'C0242698', 'cui_str': 'Ventricular Dysfunction, Left'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0221464', 'cui_str': 'Arterial (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake (observable entity)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0521164', 'cui_str': 'Annular shape (qualifier value)'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C0449829', 'cui_str': 'Geometry (attribute)'}, {'cui': 'C0013516', 'cui_str': 'Transthoracic Echocardiography'}, {'cui': 'C0178824', 'cui_str': 'Reactive Hyperemia'}, {'cui': 'C0205100', 'cui_str': 'Peripheral (qualifier value)'}, {'cui': 'C0040420', 'cui_str': 'Tonometry'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",,0.026279,"No effects were observed on LV ejection fraction, E', or reactive hyperemia index in either group.","[{'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Fujimoto', 'Affiliation': 'Department of Cardiology and Nephrology, Mie University Graduate School of Medicine, 2-174 Edobashi, Tsu, 514-8507, Japan. naokifujimo@clin.medic.mie-u.ac.jp.'}, {'ForeName': 'Keishi', 'Initials': 'K', 'LastName': 'Moriwaki', 'Affiliation': 'Department of Cardiology and Nephrology, Mie University Graduate School of Medicine, 2-174 Edobashi, Tsu, 514-8507, Japan.'}, {'ForeName': 'Tetsushiro', 'Initials': 'T', 'LastName': 'Takeuchi', 'Affiliation': 'Department of Cardiology and Nephrology, Mie University Graduate School of Medicine, 2-174 Edobashi, Tsu, 514-8507, Japan.'}, {'ForeName': 'Toshiki', 'Initials': 'T', 'LastName': 'Sawai', 'Affiliation': 'Department of Cardiology and Nephrology, Mie University Graduate School of Medicine, 2-174 Edobashi, Tsu, 514-8507, Japan.'}, {'ForeName': 'Yuichi', 'Initials': 'Y', 'LastName': 'Sato', 'Affiliation': 'Department of Cardiology and Nephrology, Mie University Graduate School of Medicine, 2-174 Edobashi, Tsu, 514-8507, Japan.'}, {'ForeName': 'Naoto', 'Initials': 'N', 'LastName': 'Kumagai', 'Affiliation': 'Department of Cardiology and Nephrology, Mie University Graduate School of Medicine, 2-174 Edobashi, Tsu, 514-8507, Japan.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Masuda', 'Affiliation': 'Department of Cardiology and Nephrology, Mie University Graduate School of Medicine, 2-174 Edobashi, Tsu, 514-8507, Japan.'}, {'ForeName': 'Shiro', 'Initials': 'S', 'LastName': 'Nakamori', 'Affiliation': 'Department of Cardiology and Nephrology, Mie University Graduate School of Medicine, 2-174 Edobashi, Tsu, 514-8507, Japan.'}, {'ForeName': 'Masaaki', 'Initials': 'M', 'LastName': 'Ito', 'Affiliation': 'Department of Cardiology and Nephrology, Mie University Graduate School of Medicine, 2-174 Edobashi, Tsu, 514-8507, Japan.'}, {'ForeName': 'Kaoru', 'Initials': 'K', 'LastName': 'Dohi', 'Affiliation': 'Department of Cardiology and Nephrology, Mie University Graduate School of Medicine, 2-174 Edobashi, Tsu, 514-8507, Japan.'}]",Heart and vessels,['10.1007/s00380-019-01526-7'] 360,32272284,Omalizumab Re-Treatment and Step-Up in Patients with Chronic Spontaneous Urticaria: OPTIMA Trial.,"BACKGROUND Omalizumab shows greater clinical benefit with 300 mg dose than with the 150 mg dose. OBJECTIVE To determine outcomes postwithdrawal, relapse, and re-treatment in omalizumab responders, and from stepping up to 300 mg after insufficient symptom control with 150 mg. METHODS This was a prospective, randomized (3:4), open-label, noncomparator study (clinicaltrials.gov: NCT02161562). A total of 314 adult patients with chronic spontaneous urticaria and symptomatic on H 1 -antihistamines were enrolled between August 1, 2014, and November 6, 2015. Patients received 150 mg/300 mg omalizumab, every 4 weeks for 24 weeks. Omalizumab 150 mg dose could be stepped up to 300 mg between week 8 and week 24, if the 7-day sum of the daily Urticaria Activity Score (UAS7) was more than 6. If patients relapsed after treatment withdrawal at week 24, they could be re-treated with the same dose on which omalizumab was started. Patients on 300 mg could extend treatment by 12 weeks if they did not achieve symptom control on 300 mg in the initial dosing phase. The primary end point was the proportion of well-controlled patients who relapsed postwithdrawal, and achieved symptom control at the end of re-treatment. Symptom control was assessed using UAS7 (UAS7 ≤ 6 = well controlled). RESULTS Overall, 115 of 314 patients had adequate symptom control at week 24 (end of the initial dosing period) and 56 were re-treated after relapse postwithdrawal; 87.8% (95% CI, 78.6%-96.9%) regained symptomatic control (UAS7 ≤ 6). Most (141 of 178) patients initially treated with 150 mg required step-up to 300 mg, which resulted in a 9.5-point (95% CI, 7.6-11.3) improvement in UAS7 over the mean change observed initially on 150 mg. CONCLUSIONS Step-up to 300 mg helps a greater proportion of patients achieve symptom control, and re-treatment with omalizumab is as effective as initial therapy.",2020,"Symptom control was assessed using the 7-day sum of daily Urticaria Activity Score (UAS7; UAS7 ≤6 = well-controlled). ","['314 adult patients with chronic spontaneous/idiopathic urticaria (CSU) and symptomatic on H 1 -antihistamines were enrolled between August 1, 2014 and November 6, 2015', 'Patients with Chronic Spontaneous Urticaria']","['omalizumab', 'Omalizumab', 'Omalizumab Retreatment and Step-Up']","['7-day sum of daily Urticaria Activity Score', 'adequate symptom control', 'UAS7 scores', 'proportion of well-controlled patients who relapsed post-withdrawal, and achieved symptom control']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0157741', 'cui_str': 'Idiopathic urticaria'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0700308', 'cui_str': 'Protium'}, {'cui': 'C0019590', 'cui_str': 'Histamine receptor antagonist'}, {'cui': 'C0578870', 'cui_str': 'Chronic idiopathic urticaria'}]","[{'cui': 'C0966225', 'cui_str': 'omalizumab'}, {'cui': 'C0376495', 'cui_str': 'Retreatments'}, {'cui': 'C0454366', 'cui_str': 'Step ups'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0042109', 'cui_str': 'Urticaria'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C1274136', 'cui_str': 'Symptom control'}, {'cui': 'C3853142', 'cui_str': 'Well controlled'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}]",314.0,0.0925635,"Symptom control was assessed using the 7-day sum of daily Urticaria Activity Score (UAS7; UAS7 ≤6 = well-controlled). ","[{'ForeName': 'Gordon', 'Initials': 'G', 'LastName': 'Sussman', 'Affiliation': 'Department of Medicine, University of Toronto, Toronto, ON, Canada. Electronic address: gsussman@rogers.com.'}, {'ForeName': 'Jacques', 'Initials': 'J', 'LastName': 'Hébert', 'Affiliation': ""Department of Medicine, Centre Hospitalier de l'Université Laval, Québec, QC, Canada.""}, {'ForeName': 'Wayne', 'Initials': 'W', 'LastName': 'Gulliver', 'Affiliation': ""Faculty of Medicine, Memorial University of Newfoundland, St John's, NL, Canada.""}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Lynde', 'Affiliation': 'Lynde Institute for Dermatology, Markham, ON, Canada.'}, {'ForeName': 'William H', 'Initials': 'WH', 'LastName': 'Yang', 'Affiliation': 'Ottawa Allergy Research Corporation, Department of Medicine, University of Ottawa Medical School, Ottawa, ON, Canada.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Papp', 'Affiliation': 'Clinical Research and Probity Medical Research, Waterloo, ON, Canada.'}, {'ForeName': 'Melinda', 'Initials': 'M', 'LastName': 'Gooderham', 'Affiliation': ""SKiN Center for Dermatology, Queen's University and Probity Medical Research, Peterborough, ON, Canada.""}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Chambenoit', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ.'}, {'ForeName': 'Sam', 'Initials': 'S', 'LastName': 'Khalil', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Frederica', 'Initials': 'F', 'LastName': 'DeTakacsy', 'Affiliation': 'Novartis Pharmaceuticals Canada Inc, Dorval, QC, Canada.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Vieira', 'Affiliation': 'Novartis Pharmaceuticals Canada Inc, Dorval, QC, Canada.'}, {'ForeName': 'Lenka', 'Initials': 'L', 'LastName': 'Rihakova', 'Affiliation': 'Novartis Pharmaceuticals Canada Inc, Dorval, QC, Canada.'}]",The journal of allergy and clinical immunology. In practice,['10.1016/j.jaip.2020.03.022'] 361,32272458,Refinement of a protocol to induce reliable muscle cramps in the abductor hallucis.,"OBJECTIVE To test the reliability of immediate replication of muscle cramp characteristics induced with different electrical stimulation protocols. APPROACH Five (age 33.8 ± 5.7 y, 60% male) and ten (age 47.4 ± 11.7 y, 60% male) participants completed independent discovery and validation cohorts, respectively. This was to identify a protocol that resulted in consistent muscle cramp characteristics (discovery), and to examine the test-retest reliability of the identified protocol (validation). Electrical stimulation (150 burst) at abductor hallucis motor-point was used to induce muscle cramps with 4 Hz increments in stimulation frequency (8-32 Hz) or until muscle cramp was first evident, followed by refinement (2 and 1 Hz) until at least two muscle cramps occurred. This defined the cramp threshold frequency, and concurrent electromyogram activity and duration of the cramp were quantified. The discovery cohort involved three separate randomised sessions where intervals between stimulation was 60, 90, and 120 s respectively. In each session, four randomised electrical stimulation protocols were completed. Stimulation current was fixed at 10, 20, and 30% higher than m-wave stimulation current (protocols 1-3 respectively), or randomised within 4 Hz steps (protocol 4) to minimise any order effect. MAIN RESULTS We were able to immediately replicate tolerable muscle cramp at least twice. Discovery cohort demonstrated (i) incremental changes in stimulation frequency (protocols 1-3 vs. protocol 4, i.e. order effect), and (ii) changes in stimulation current with differing protocols did not significantly alter the prevailing muscle cramp characteristics, and (iii) defining the muscle cramp characteristics elicits good-to-excellent inter-observer reliability. The validation cohort's test-retest reliability and the minimum detectable change were improved for all muscle cramp characteristics when immediately replicated more than twice at the lowest stimulation frequency. SIGNIFICANCE This study provides evidence for a reliable method for inducing repeatable muscle cramps in abductor hallucis.",2020,"The validation cohort's test-retest reliability and the minimum detectable change were improved for all muscle cramp characteristics when immediately replicated more than twice at the lowest stimulation frequency. ","['abductor hallucis', 'APPROACH\n\n\nFive (age 33.8 ± 5.7 y, 60% male) and ten (age 47.4 ± 11.7 y, 60% male']",['Electrical stimulation'],['muscle cramps'],"[{'cui': 'C0224490', 'cui_str': 'Structure of abductor hallucis muscle'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517795', 'cui_str': '5.7'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C4517535', 'cui_str': '11.7'}]","[{'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}]","[{'cui': 'C0026821', 'cui_str': 'Cramp'}]",,0.0496055,"The validation cohort's test-retest reliability and the minimum detectable change were improved for all muscle cramp characteristics when immediately replicated more than twice at the lowest stimulation frequency. ","[{'ForeName': 'Ashley P', 'Initials': 'AP', 'LastName': 'Akerman', 'Affiliation': 'Department of Medicine, Dunedin School of Medicine, University of Otago, New Zealand.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Walker', 'Affiliation': ''}, {'ForeName': 'John B W', 'Initials': 'JBW', 'LastName': 'Schollum', 'Affiliation': ''}, {'ForeName': 'Tracey L', 'Initials': 'TL', 'LastName': 'Putt', 'Affiliation': ''}, {'ForeName': 'Luke C', 'Initials': 'LC', 'LastName': 'Wilson', 'Affiliation': ''}]",Physiological measurement,['10.1088/1361-6579/ab8855'] 362,32166619,"Model-based Prediction of the Long-term Glucose-Lowering Effects of Ipragliflozin, a Selective Sodium-Glucose Cotransporter 2 (SGLT2) Inhibitor, in Patients with Type 2 Diabetes Mellitus.","INTRODUCTION Sodium-dependent glucose cotransporter 2 (SGLT2) inhibitors inhibit the reabsorption of glucose from the kidneys and increase urinary glucose excretion (UGE), thereby lowering the blood glucose concentration in people suffering from type 1 and type 2 diabetes mellitus (T2DM). In a previous study, we reported a pharmacokinetics/pharmacodynamics model to estimate individual change in UGE (ΔUGE), which is a direct pharmacological effect of SGLT2 inhibitors. In this study, we report our enhancement of the previous model to predict the long-term effects of ipragliflozin on clinical outcomes in patients with T2DM. METHODS The time course of fasting plasma glucose (FPG) and hemoglobin A1c (HbA1c) in patients with T2DM following ipragliflozin treatment that had been observed in earlier clinical trials was modeled using empirical models combined with the maximum drug effect (E max ) model and disease progression model. As a predictive factor of drug effect, estimated ΔUGE was introduced into the E max model, instead of ipragliflozin exposure. The developed models were used to simulate the time course of FPG and HbA1c following once-daily treatment with placebo or ipragliflozin at doses of 12.5, 25, 50 and 100 mg, and the changes at 52 weeks at the approved dose of 50 mg were summarized by renal function category. RESULTS The developed models that included UGE as a dependent variable of response were found to well describe observed time courses in FPG and HbA1c. Baseline blood glucose level and renal function had significant effects on the glucose-lowering effect of ipragliflozin, and these models enabled quantification of these impacts on clinical outcomes. Simulated median changes in HbA1c in T2DM patients with mild and moderate renal impairment were 25 and 63% lower, respectively, than those in T2DM patients with normal renal function. These results are consistent with the observed clinical data from a previous renal impairment study. CONCLUSIONS Empirical models established based on the effect of UGE well predicted the renal function-dependent long-term glucose-lowering effects of ipragliflozin in patients with T2DM.",2020,"Baseline blood glucose level and renal function had significant effects on the glucose-lowering effect of ipragliflozin, and these models enabled quantification of these impacts on clinical outcomes.","['patients with T2DM', 'Patients with Type 2 Diabetes Mellitus', 'patients with T2DM following', 'people suffering from type 1 and type 2 diabetes mellitus (T2DM']","['Sodium-dependent glucose cotransporter 2 (SGLT2) inhibitors', 'ipragliflozin', 'placebo or ipragliflozin', 'Ipragliflozin, a Selective Sodium-Glucose Cotransporter 2']","['Baseline blood glucose level and renal function', 'time course of fasting plasma glucose (FPG) and hemoglobin A1c (HbA1c', 'moderate renal impairment']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0441729', 'cui_str': 'Type 1 (qualifier value)'}, {'cui': 'C0011860', 'cui_str': 'Diabetes Mellitus, Type 2'}]","[{'cui': 'C3541959', 'cui_str': 'Sodium supplement (substance)'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C3492889', 'cui_str': 'ipragliflozin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0017739', 'cui_str': 'Sodium-Glucose Transport Proteins'}]","[{'cui': 'C0428554', 'cui_str': 'Blood glucose result - finding'}, {'cui': 'C0232804', 'cui_str': 'Renal function (observable entity)'}, {'cui': 'C0449247', 'cui_str': 'Time course (attribute)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma (procedure)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C4521595', 'cui_str': 'Lcpl'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C1565489', 'cui_str': 'Renal Insufficiency'}]",,0.036441,"Baseline blood glucose level and renal function had significant effects on the glucose-lowering effect of ipragliflozin, and these models enabled quantification of these impacts on clinical outcomes.","[{'ForeName': 'Masako', 'Initials': 'M', 'LastName': 'Saito', 'Affiliation': 'Astellas Pharma Inc., Tokyo, Japan. masako.saito@astellas.com.'}, {'ForeName': 'Atsunori', 'Initials': 'A', 'LastName': 'Kaibara', 'Affiliation': 'Astellas Pharma Inc., Tokyo, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Kadokura', 'Affiliation': 'Astellas Pharma Inc., Tokyo, Japan.'}, {'ForeName': 'Junko', 'Initials': 'J', 'LastName': 'Toyoshima', 'Affiliation': 'Astellas Pharma Inc., Tokyo, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Yoshida', 'Affiliation': 'Astellas Pharma Inc., Tokyo, Japan.'}, {'ForeName': 'Kenichi', 'Initials': 'K', 'LastName': 'Kazuta', 'Affiliation': 'Astellas Pharma Inc., Tokyo, Japan.'}, {'ForeName': 'Eiji', 'Initials': 'E', 'LastName': 'Ueyama', 'Affiliation': 'Astellas Pharma Inc., Tokyo, Japan.'}]","Diabetes therapy : research, treatment and education of diabetes and related disorders",['10.1007/s13300-020-00785-2'] 363,32274541,[Treatment concepts for primary oligometastatic prostate cancer].,"BACKGROUND About 5% of prostate cancer patients have distant metastases at diagnosis. In these metastatic hormone-sensitive prostate cancers (mHSPC), systemic therapy is recommended, according to the guidelines. Moreover, metastasis-directed therapy (MDT) is discussed to prolong survival. OBJECTIVES The contemporary literature concerning local therapy and MDT in patients with mHSPC is summarized. METHODS Selective literature search. RESULTS In 2018, randomized controlled data on local therapy in mHSPC patients were published by the authors of the STAMPEDE study. Here, patients were randomized between standard of care (SOC) ± radiotherapy to the prostate (RT). Within the overall cohort, no difference regarding 3‑year overall survival (OS) was observed. Within a prespecified subgroup of patients with low metastatic burden. Similar results were observed in numerous retrospective studies analyzing radical prostatectomy; prospective randomized studies are pending. For MDT, there are no sufficient data in mHSPC patients yet. CONCLUSIONS In the current guidelines, systematic therapy is standard of care in mHSPC patients. In patients with low metastatic burden, a survival benefit was observed when adding percutaneous RT to the prostate. Retrospective studies also suggest a benefit when adding RP. However, whether MDT prolongs survival is still unknown.",2020,"Within the overall cohort, no difference regarding 3‑year overall survival (OS) was observed.","['patients with low metastatic burden', 'primary oligometastatic prostate cancer', 'patients with mHSPC', 'mHSPC patients']","['MDT', 'standard of care (SOC)\u202f±\u2009radiotherapy to the prostate (RT']","['survival benefit', '3‑year overall survival (OS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C4302896', 'cui_str': 'Hormone sensitive prostate cancer'}]","[{'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0033572', 'cui_str': 'Prostatic'}]","[{'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",,0.121008,"Within the overall cohort, no difference regarding 3‑year overall survival (OS) was observed.","[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Knipper', 'Affiliation': 'Martini-Klinik Prostatakarzinomzentrum, Universitätsklinikum Hamburg-Eppendorf, Martinistr.\xa052, 20246, Hamburg, Deutschland. a.knipper@uke.de.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Graefen', 'Affiliation': 'Martini-Klinik Prostatakarzinomzentrum, Universitätsklinikum Hamburg-Eppendorf, Martinistr.\xa052, 20246, Hamburg, Deutschland.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Hadaschik', 'Affiliation': 'Klinik und Poliklinik für Urologie, Kinderurologie und Uroonkologie, Universitätsklinikum Essen, Essen, Deutschland.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Wiegel', 'Affiliation': 'Klinik für Radioonkologie und Strahlentherapie, Universitätsklinikum Ulm, Ulm, Deutschland.'}]",Der Urologe. Ausg. A,['10.1007/s00120-020-01186-w'] 364,32267771,The REMAP-CAP (Randomized Embedded Multifactorial Adaptive Platform for Community-acquired Pneumonia) Study. Rationale and Design.,"There is broad interest in improved methods to generate robust evidence regarding best practice, especially in settings where patient conditions are heterogenous and require multiple concomitant therapies. Here, we present the rationale and design of a large, international trial that combines features of adaptive platform trials with pragmatic point-of-care trials to determine best treatment strategies for patients admitted to an intensive care unit with severe community-acquired pneumonia. The trial uses a novel design, entitled ""a randomized embedded multifactorial adaptive platform."" The design has five key features: 1 ) randomization, allowing robust causal inference; 2 ) embedding of study procedures into routine care processes, facilitating enrollment, trial efficiency, and generalizability; 3 ) a multifactorial statistical model comparing multiple interventions across multiple patient subgroups; 4 ) response-adaptive randomization with preferential assignment to those interventions that appear most favorable; and 5 ) a platform structured to permit continuous, potentially perpetual enrollment beyond the evaluation of the initial treatments. The trial randomizes patients to multiple interventions within four treatment domains: antibiotics, antiviral therapy for influenza, host immunomodulation with extended macrolide therapy, and alternative corticosteroid regimens, representing 240 treatment regimens. The trial generates estimates of superiority, inferiority, and equivalence between regimens on the primary outcome of 90-day mortality, stratified by presence or absence of concomitant shock and proven or suspected influenza infection. The trial will also compare ventilatory and oxygenation strategies, and has capacity to address additional questions rapidly during pandemic respiratory infections. As of January 2020, REMAP-CAP (Randomized Embedded Multifactorial Adaptive Platform for Community-acquired Pneumonia) was approved and enrolling patients in 52 intensive care units in 13 countries on 3 continents. In February, it transitioned into pandemic mode with several design adaptations for coronavirus disease 2019. Lessons learned from the design and conduct of this trial should aid in dissemination of similar platform initiatives in other disease areas.Clinical trial registered with www.clinicaltrials.gov (NCT02735707).",2020,"The trial generates estimates of superiority, inferiority and equivalence between regimens on the primary outcome of 90-day mortality, stratified by presence or absence of concomitant shock and proven or suspected influenza infection.","['multiple patient subgroups', 'Community-acquired Pneumonia (REMAP-CAP', 'patients admitted to an intensive care unit with severe community-acquired pneumonia (CAP']","['antibiotics, antiviral therapy for influenza, host immunomodulation with extended macrolide therapy, and alternative corticosteroid regimens']","['90-day mortality, stratified by presence or absence of concomitant shock and proven or suspected influenza infection']","[{'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0694549', 'cui_str': 'Community acquired pneumonia'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]","[{'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0280274', 'cui_str': 'Antiviral therapy'}, {'cui': 'C0021400', 'cui_str': 'Influenza'}, {'cui': 'C1963758', 'cui_str': 'Immunomodulatory therapy'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0003240', 'cui_str': 'Macrolide antibiotic product'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0036974', 'cui_str': 'Shock'}, {'cui': 'C0456369', 'cui_str': 'Proven'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0021400', 'cui_str': 'Influenza'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}]",,0.108372,"The trial generates estimates of superiority, inferiority and equivalence between regimens on the primary outcome of 90-day mortality, stratified by presence or absence of concomitant shock and proven or suspected influenza infection.","[{'ForeName': 'Derek C', 'Initials': 'DC', 'LastName': 'Angus', 'Affiliation': 'The Clinical Research Investigation and Systems Modeling of Acute Illness Center, Department of Critical Care Medicine, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Berry', 'Affiliation': 'Berry Consultants, LLC, Austin, Texas.'}, {'ForeName': 'Roger J', 'Initials': 'RJ', 'LastName': 'Lewis', 'Affiliation': 'Berry Consultants, LLC, Austin, Texas.'}, {'ForeName': 'Farah', 'Initials': 'F', 'LastName': 'Al-Beidh', 'Affiliation': 'Division of Anaesthetics, Pain Medicine and Intensive Care Medicine, Department of Surgery and Cancer, Imperial College London and Imperial College Healthcare National Health Service Trust, London, United Kingdom.'}, {'ForeName': 'Yaseen', 'Initials': 'Y', 'LastName': 'Arabi', 'Affiliation': 'Intensive Care Department, College of Medicine, King Saud Bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, King Abdulaziz Medical City, Riyadh, Saudi Arabia.'}, {'ForeName': 'Wilma', 'Initials': 'W', 'LastName': 'van Bentum-Puijk', 'Affiliation': 'Julius Center for Health Sciences and Primary Care.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Bhimani', 'Affiliation': ""Li Ka Shing Knowledge Institute, St. Michael's Hospital, Toronto, Ontario, Canada.""}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Bonten', 'Affiliation': 'Julius Center for Health Sciences and Primary Care.'}, {'ForeName': 'Kristine', 'Initials': 'K', 'LastName': 'Broglio', 'Affiliation': 'Berry Consultants, LLC, Austin, Texas.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Brunkhorst', 'Affiliation': 'Center for Clinical Studies and Center for Sepsis Control and Care, Department of Anesthesiology and Intensive Care Medicine, Jena University Hospital, Jena, Germany.'}, {'ForeName': 'Allen C', 'Initials': 'AC', 'LastName': 'Cheng', 'Affiliation': 'Infection Prevention and Healthcare Epidemiology Unit, Alfred Health, Melbourne, Victoria, Australia.'}, {'ForeName': 'Jean-Daniel', 'Initials': 'JD', 'LastName': 'Chiche', 'Affiliation': 'Medical Intensive Care Unit, Hôpital Cochin, Paris Descartes University, Paris, France.'}, {'ForeName': 'Menno', 'Initials': 'M', 'LastName': 'De Jong', 'Affiliation': 'Department of Medical Microbiology, Amsterdam University Medical Center, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Detry', 'Affiliation': 'Berry Consultants, LLC, Austin, Texas.'}, {'ForeName': 'Herman', 'Initials': 'H', 'LastName': 'Goossens', 'Affiliation': 'Department of Microbiology, Antwerp University Hospital, Antwerp, Belgium.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Gordon', 'Affiliation': 'Division of Anaesthetics, Pain Medicine and Intensive Care Medicine, Department of Surgery and Cancer, Imperial College London and Imperial College Healthcare National Health Service Trust, London, United Kingdom.'}, {'ForeName': 'Cameron', 'Initials': 'C', 'LastName': 'Green', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, School of Epidemiology and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Alisa M', 'Initials': 'AM', 'LastName': 'Higgins', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, School of Epidemiology and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Sebastiaan J', 'Initials': 'SJ', 'LastName': 'Hullegie', 'Affiliation': 'Julius Center for Health Sciences and Primary Care.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Kruger', 'Affiliation': 'Intensive Care Unit, Princess Alexandra Hospital, Brisbane, Queensland, Australia.'}, {'ForeName': 'Francois', 'Initials': 'F', 'LastName': 'Lamontagne', 'Affiliation': 'Université de Sherbrooke, Sherbrooke, Quebec, Canada.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Litton', 'Affiliation': 'School of Medicine and Pharmacology, University of Western Australia, Crawley, Western Australia, Australia.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Marshall', 'Affiliation': ""Li Ka Shing Knowledge Institute, St. Michael's Hospital, Toronto, Ontario, Canada.""}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'McGlothlin', 'Affiliation': 'Berry Consultants, LLC, Austin, Texas.'}, {'ForeName': 'Shay', 'Initials': 'S', 'LastName': 'McGuinness', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, School of Epidemiology and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Mouncey', 'Affiliation': 'Clinical Trials Unit, Intensive Care National Audit & Research Centre, London, United Kingdom.'}, {'ForeName': 'Srinivas', 'Initials': 'S', 'LastName': 'Murthy', 'Affiliation': 'University of British Columbia School of Medicine, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Alistair', 'Initials': 'A', 'LastName': 'Nichol', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, School of Epidemiology and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Genevieve K', 'Initials': 'GK', 'LastName': ""O'Neill"", 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, School of Epidemiology and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Rachael', 'Initials': 'R', 'LastName': 'Parke', 'Affiliation': 'Cardiothoracic and Vascular Intensive Care Unit and.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Parker', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, School of Epidemiology and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Gernot', 'Initials': 'G', 'LastName': 'Rohde', 'Affiliation': 'Department of Respiratory Medicine, University Hospital Frankfurt, Frankfurt, Germany.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Rowan', 'Affiliation': 'Clinical Trials Unit, Intensive Care National Audit & Research Centre, London, United Kingdom.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Turner', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington, New Zealand.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Young', 'Affiliation': 'Medical Research Institute of New Zealand, Wellington, New Zealand.'}, {'ForeName': 'Lennie', 'Initials': 'L', 'LastName': 'Derde', 'Affiliation': 'Julius Center for Health Sciences and Primary Care.'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'McArthur', 'Affiliation': 'Department of Critical Care Medicine, Auckland City Hospital, Auckland, New Zealand.'}, {'ForeName': 'Steven A', 'Initials': 'SA', 'LastName': 'Webb', 'Affiliation': 'Australian and New Zealand Intensive Care Research Centre, School of Epidemiology and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}]",Annals of the American Thoracic Society,['10.1513/AnnalsATS.202003-192SD'] 365,32273276,Evaluation of Cyclophosphamide/GVAX Pancreas Followed by Listeria-Mesothelin (CRS-207) with or without Nivolumab in Patients with Pancreatic Cancer.,"PURPOSE Two studies in previously treated metastatic pancreatic cancer have been completed combining GVAX pancreas vaccine (GM-CSF-secreting allogeneic pancreatic tumor cells) with cyclophosphamide (Cy) and CRS-207 (live, attenuated Listeria monocytogenes -expressing mesothelin). In the current study, we compared Cy/GVAX followed by CRS-207 with (Arm A) or without nivolumab (Arm B). EXPERIMENTAL DESIGN Patients with pancreatic adenocarcinoma who received one prior therapy for metastatic disease and RECIST measurable disease were randomized 1:1 to receive treatment on Arm A or Arm B. The primary objective was to compare overall survival (OS) between the arms. Additional objectives included assessment of progression-free survival, safety, tumor responses, CA19-9 responses, and immunologic correlates. RESULTS Ninety-three patients were treated (Arm A, 51; Arm B, 42). The median OS in Arms A and B were 5.9 [95% confidence interval (CI), 4.7-8.6] and 6.1 (95% CI, 3.5-7.0) months, respectively, with an HR of 0.86 (95% CI, 0.55-1.34). Objective responses were seen in 3 patients using immune-related response criteria (4%, 2/51, Arm A; 2%, 1/42, Arm B). The grade ≥3 related adverse event rate, whereas higher in Arm A (35.3% vs. 11.9%) was manageable. Changes in the microenvironment, including increase in CD8 + T cells and a decrease in CD68 + myeloid cells, were observed in long-term survivors in Arm A only. CONCLUSIONS Although the study did not meet its primary endpoint of improvement in OS of Arm A over Arm B, the OS was comparable with standard therapy. Objective responses and immunologic changes in the tumor microenvironment were evident.",2020,"Changes in the microenvironment, including increase in CD8 + T cells and a decrease in CD68 + myeloid cells, were observed in long-term survivors in Arm A only. ","['previously-treated metastatic pancreatic cancer', 'Patients with pancreatic adenocarcinoma who received one prior therapy for metastatic disease and RECIST measurable disease', 'Patients with Pancreatic Cancer']","['Cyclophosphamide/GVAX Pancreas Followed by Listeria-mesothelin (CRS-207', 'GVAX pancreas vaccine (granulocyte-macrophage colony-stimulating factor-secreting allogeneic pancreatic tumor cells) with cyclophosphamide (Cy) and CRS-207']","['adverse event rate', 'CD8 + T cells', 'progression-free survival, safety, tumor responses, CA19-9 responses and immunologic correlates', 'overall survival (OS', 'Objective responses', 'CD68 + myeloid cells', 'median OS']","[{'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0346976', 'cui_str': 'Secondary malignant neoplasm of pancreas'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0281361', 'cui_str': 'Adenocarcinoma of pancreas'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1709926', 'cui_str': 'RECIST'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0235974', 'cui_str': 'Carcinoma of pancreas'}]","[{'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0771711', 'cui_str': 'Pancreas extract'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0023859', 'cui_str': 'Listeria'}, {'cui': 'C0380162', 'cui_str': 'mesothelin'}, {'cui': 'C0010278', 'cui_str': 'Craniosynostosis syndrome'}, {'cui': 'C0030274', 'cui_str': 'Pancreatic structure'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0018183', 'cui_str': 'Granulocyte'}, {'cui': 'C0079784', 'cui_str': 'Colony-stimulating factor, macrophage'}, {'cui': 'C0030297', 'cui_str': 'Neoplasm of pancreas'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0242629', 'cui_str': 'Lymphocyte positive for CD8 antigen'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0006613', 'cui_str': 'Cancer antigen 19-9'}, {'cui': 'C0152036', 'cui_str': 'Immunology'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0108799', 'cui_str': 'Lymphocyte antigen CD68'}, {'cui': 'C0596993', 'cui_str': 'Stem Cells, Myeloid'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",93.0,0.0916246,"Changes in the microenvironment, including increase in CD8 + T cells and a decrease in CD68 + myeloid cells, were observed in long-term survivors in Arm A only. ","[{'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Tsujikawa', 'Affiliation': 'Oregon Health and Science University, Portland, Oregon.'}, {'ForeName': 'Todd', 'Initials': 'T', 'LastName': 'Crocenzi', 'Affiliation': 'Providence Portland Medical Center, Portland, Oregon.'}, {'ForeName': 'Jennifer N', 'Initials': 'JN', 'LastName': 'Durham', 'Affiliation': 'Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Sugar', 'Affiliation': 'Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland.'}, {'ForeName': 'Annie A', 'Initials': 'AA', 'LastName': 'Wu', 'Affiliation': 'Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland.'}, {'ForeName': 'Beth', 'Initials': 'B', 'LastName': 'Onners', 'Affiliation': 'Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland.'}, {'ForeName': 'Julie M', 'Initials': 'JM', 'LastName': 'Nauroth', 'Affiliation': 'Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Anders', 'Affiliation': 'Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland.'}, {'ForeName': 'Elana J', 'Initials': 'EJ', 'LastName': 'Fertig', 'Affiliation': 'Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland.'}, {'ForeName': 'Daniel A', 'Initials': 'DA', 'LastName': 'Laheru', 'Affiliation': 'Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Reiss', 'Affiliation': 'Abramson Cancer Center at the University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Robert H', 'Initials': 'RH', 'LastName': 'Vonderheide', 'Affiliation': 'Abramson Cancer Center at the University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Andrew H', 'Initials': 'AH', 'LastName': 'Ko', 'Affiliation': 'University of California San Francisco, San Francisco, California.'}, {'ForeName': 'Margaret A', 'Initials': 'MA', 'LastName': 'Tempero', 'Affiliation': 'University of California San Francisco, San Francisco, California.'}, {'ForeName': 'George A', 'Initials': 'GA', 'LastName': 'Fisher', 'Affiliation': 'Stanford University, Palo Alto, California.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Considine', 'Affiliation': 'Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland.'}, {'ForeName': 'Ludmila', 'Initials': 'L', 'LastName': 'Danilova', 'Affiliation': 'Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland.'}, {'ForeName': 'Dirk G', 'Initials': 'DG', 'LastName': 'Brockstedt', 'Affiliation': 'Aduro Biotech Inc., Berkeley, California.'}, {'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'Coussens', 'Affiliation': 'Oregon Health and Science University, Portland, Oregon.'}, {'ForeName': 'Elizabeth M', 'Initials': 'EM', 'LastName': 'Jaffee', 'Affiliation': 'Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland.'}, {'ForeName': 'Dung T', 'Initials': 'DT', 'LastName': 'Le', 'Affiliation': 'Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland. dle@jhmi.edu.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-19-3978'] 366,32065359,Comparison of the Efficacy and Safety of Rosuvastatin/Ezetimibe Combination Therapy and Rosuvastatin Monotherapy on Lipoprotein in Patients With Type 2 Diabetes: Multicenter Randomized Controlled Study.,"INTRODUCTION Ezetimibe/statin combination therapy has been reported to provide additional cardioprotective effects compared to statin monotherapy. The apolipoprotein B/A1 (apoB/A1) ratio is an effective predictor of cardiovascular diseases. The aim of this study was to compare the efficacy and safety of rosuvastatin/ezetimibe combination therapy versus rosuvastatin monotherapy using the apoB/A1 ratio in patients with diabetes and hypercholesterolemia. METHODS In this randomized, multicenter, open-label, parallel-group study, patients were randomly assigned to receive the combination therapy of rosuvastatin 5 mg/ezetimibe 10 mg once daily (n = 68) or monotherapy with rosuvastatin 10 mg once daily (n = 68), for 8 weeks. RESULTS After the 8-week treatment, percentage change (least-square means ± standard error) in the apoB/A1 ratio in the rosuvastatin/ezetimibe group was significantly decreased compared to the rosuvastatin group (- 46.14 ± 1.58% vs.  - 41.30 ± 1.58%, respectively; P = 0.03). In addition, the proportion of patients achieving > 50% reduction in low-density lipoprotein-cholesterol (LDL-C) and in the comprehensive lipid target (LDL-C < 70 mg/dL, non-HDL-cholesterol [non-HDL-C] < 100 mg/dL, and apoB < 80 mg/dL) was significantly different between the two groups (76.5 and 73.5% in the rosuvastatin/ezetimibe group and 47.1 and 45.6% in the rosuvastatin group, respectively; P < 0.001). The reduction in total cholesterol, non-HDL-C, LDL-C, and apoB were greater in the rosuvastatin/ezetimibe group than in the rosuvastatin group. Both treatments were well tolerated, and no between-group differences in drug-related adverse events were observed. CONCLUSION The apoB/A1 ratio was significantly reduced in patients receiving combination therapy with ezetimibe and rosuvastatin compared to those receiving rosuvastatin monotherapy. Both treatments were well tolerated in patients with type 2 diabetes and hypercholesterolemia. TRIAL REGISTRATION NCT03446261.",2020,"The reduction in total cholesterol, non-HDL-C, LDL-C, and apoB were greater in the rosuvastatin/ezetimibe group than in the rosuvastatin group.","['Patients With Type 2 Diabetes', 'patients with diabetes and hypercholesterolemia', 'patients with type 2 diabetes and hypercholesterolemia']","['monotherapy with rosuvastatin', 'rosuvastatin 5\xa0mg/ezetimibe', 'Ezetimibe/statin combination therapy', 'ezetimibe and rosuvastatin', 'rosuvastatin/ezetimibe combination therapy versus rosuvastatin monotherapy', 'Rosuvastatin/Ezetimibe Combination Therapy and Rosuvastatin Monotherapy', 'rosuvastatin/ezetimibe', 'rosuvastatin', 'rosuvastatin monotherapy']","['drug-related adverse events', 'efficacy and safety', 'tolerated', 'apoB/A1 ratio', 'total cholesterol, non-HDL-C, LDL-C, and apoB', 'low-density lipoprotein-cholesterol (LDL-C']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0020443', 'cui_str': 'High Cholesterol Levels'}]","[{'cui': 'C0965129', 'cui_str': 'rosuvastatin'}, {'cui': 'C1142985', 'cui_str': 'ezetimibe'}, {'cui': 'C0360714', 'cui_str': 'Statins'}, {'cui': 'C0556895', 'cui_str': 'Combination therapy (regime/therapy)'}]","[{'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0003593', 'cui_str': 'ApoB'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement (procedure)'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}]",,0.0149835,"The reduction in total cholesterol, non-HDL-C, LDL-C, and apoB were greater in the rosuvastatin/ezetimibe group than in the rosuvastatin group.","[{'ForeName': 'Jiwoo', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, Asan Medical Center, University of Ulsan College of Medicine, 88, Olympic-ro 43-gil, Songpa-gu, Seoul, 05505, Korea.'}, {'ForeName': 'You-Cheol', 'Initials': 'YC', 'LastName': 'Hwang', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Medicine, Kyung Hee University Hospital at Gangdong, Kyung Hee University School of Medicine, 892, Dongnam-ro, Gangdong-gu, Seoul, 05278, Korea.'}, {'ForeName': 'Woo Je', 'Initials': 'WJ', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, Asan Medical Center, University of Ulsan College of Medicine, 88, Olympic-ro 43-gil, Songpa-gu, Seoul, 05505, Korea.'}, {'ForeName': 'Jong Chul', 'Initials': 'JC', 'LastName': 'Won', 'Affiliation': 'Department of Internal Medicine, Sanggye Paik Hospital, Inje University College of Medicine, 1342, Dongil-ro, Nowon-gu, Seoul, 01757, Korea.'}, {'ForeName': 'Kee-Ho', 'Initials': 'KH', 'LastName': 'Song', 'Affiliation': 'Division of Endocrinology and Metabolism, Konkuk University Medical Center, Konkuk University School of Medicine, 120, Neungdong-ro, Gwangjin-gu, Seoul, 05029, Korea.'}, {'ForeName': 'Cheol-Young', 'Initials': 'CY', 'LastName': 'Park', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Internal Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, 29, Saemunan-ro, Jongno-gu, Seoul, 03181, Korea.'}, {'ForeName': 'Kyu Jeung', 'Initials': 'KJ', 'LastName': 'Ahn', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Medicine, Kyung Hee University Hospital at Gangdong, Kyung Hee University School of Medicine, 892, Dongnam-ro, Gangdong-gu, Seoul, 05278, Korea. ahnkj@khu.ac.kr.'}, {'ForeName': 'Joong-Yeol', 'Initials': 'JY', 'LastName': 'Park', 'Affiliation': 'Department of Internal Medicine, Asan Medical Center, University of Ulsan College of Medicine, 88, Olympic-ro 43-gil, Songpa-gu, Seoul, 05505, Korea. jypark@amc.seoul.kr.'}]","Diabetes therapy : research, treatment and education of diabetes and related disorders",['10.1007/s13300-020-00778-1'] 367,32269052,"Impact of Neoadjuvant Durvalumab with or without Tremelimumab on CD8 + Tumor Lymphocyte Density, Safety, and Efficacy in Patients with Oropharynx Cancer: CIAO Trial Results.","PURPOSE In oropharyngeal squamous cell carcinoma (OPC), high CD8 + tumor-infiltrating lymphocyte (CD8 + TIL) density confers improved prognosis. We compared neoadjuvant durvalumab (PD-L1 inhibitor) with durvalumab + tremelimumab (CTLA-4 inhibitor) in terms of impact on CD8 + TIL density, safety, and efficacy in patients with OPC. PATIENTS AND METHODS Patients with newly diagnosed stage II-IVA OPC or locoregionally recurrent OPC amenable to resection were included. Patients were randomized to two cycles of durvalumab or durvalumab + tremelimumab before surgery. The primary endpoint was change between baseline and resection specimen in CD8 + TIL density between arms. Secondary endpoints included safety, response rate per RECIST, major pathologic response (MPR; ≤10% viable tumor cells) rate, and patient-reported outcomes. RESULTS Of 28 eligible patients (14/arm), 20 (71%) had newly diagnosed OPC, and 24 (86%) were p16-positive. The posttreatment to pretreatment median CD8 + TIL density ratio was 1.31 for durvalumab and 1.15 for combination treatment ( P = 0.97; 95% CI: -1.07-2.28). In each group, 6 patients (43%, 95% CI: 17.66-71.14) had a response. Eight patients (29%) had a MPR at the primary tumor and/or nodal metastases. Neither baseline CD8 + TIL density nor PD-L1 expression level correlated with overall response, but a trend toward greater CD8 + TIL change in patients with a MPR was seen ( P = 0.059; 95% CI: -0.33-3.46). Four patients (14%) had grade ≥3 adverse events. At median follow-up time of 15.79 months, all patients were alive, and one had an additional recurrence. CONCLUSIONS Durvalumab + tremelimumab did not increase CD8 + TIL density more than durvalumab alone did. The observed safety and activity support further investigation of neoadjuvant checkpoint inhibitor for OPC.",2020,"The posttreatment to pretreatment median CD8 + TIL density ratio was 1.31 for durvalumab and 1.15 for combination treatment ( P =.97, 95%CI:(-1.07,2.28)).","['Patients with newly diagnosed stage II-IVA OPC or locoregionally-recurrent OPC amenable to resection were included', 'OPC patients', 'patients with oropharynx cancer', '28 eligible patients (14 per arm), 20 (71%) had newly diagnosed OPC, and 24 (86%) were p16-positive', 'oropharyngeal squamous cell carcinoma (OPC']","['durvalumab or durvalumab plus tremelimumab', 'neoadjuvant durvalumab (PD-L1 inhibitor) with durvalumab plus tremelimumab (CTLA-4 inhibitor', 'neoadjuvant durvalumab with or without tremelimumab']","['change between baseline and resection specimen in CD8 + TIL density', 'CD8+ tumor lymphocyte density, safety, and efficacy', 'median CD8 + TIL density ratio', 'CD8 + TIL density', 'safety, response rate per RECIST, major pathologic response (MPR; ≤10% viable tumor cells) rate, and patient-reported outcomes', 'additional recurrence', 'CD8 + TIL density, safety, and efficacy', 'CD8 + TIL change', 'baseline CD8 + TIL density nor PD-L1 expression level', 'grade ≥3 adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2'}, {'cui': 'C0268575', 'cui_str': 'Isovaleryl-CoA dehydrogenase deficiency'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0153382', 'cui_str': 'Malignant tumor of oropharynx'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0249880', 'cui_str': 'Cdk4-Associated Protein p16'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0280313', 'cui_str': 'Squamous cell carcinoma of oropharynx'}]","[{'cui': 'C4055109', 'cui_str': 'durvalumab'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C2351038', 'cui_str': 'tremelimumab'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0965245', 'cui_str': 'CD274 protein, human'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0111208', 'cui_str': 'Cytotoxic T-Lymphocyte Antigen 4'}]","[{'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0085358', 'cui_str': 'Lymphocyte antigen CD8'}, {'cui': 'C0079722', 'cui_str': 'Tumor-Infiltrating Lymphocytes'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0024264', 'cui_str': 'Lymphocyte'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C1709926', 'cui_str': 'RECIST'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1521733', 'cui_str': 'Pathologic'}, {'cui': 'C1431543', 'cui_str': 'PGRMC1 protein, human'}, {'cui': 'C0443348', 'cui_str': 'Viable'}, {'cui': 'C0431085', 'cui_str': 'Tumor cells, uncertain whether benign or malignant'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0965245', 'cui_str': 'CD274 protein, human'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",28.0,0.159168,"The posttreatment to pretreatment median CD8 + TIL density ratio was 1.31 for durvalumab and 1.15 for combination treatment ( P =.97, 95%CI:(-1.07,2.28)).","[{'ForeName': 'Renata', 'Initials': 'R', 'LastName': 'Ferrarotto', 'Affiliation': 'Department of Thoracic/Head and Neck Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas. rferrarotto@mdanderson.org.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Bell', 'Affiliation': 'Department of Pathology, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Maria L', 'Initials': 'ML', 'LastName': 'Rubin', 'Affiliation': 'Department of Biostatistics, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Katherine A', 'Initials': 'KA', 'LastName': 'Hutcheson', 'Affiliation': 'Department of Head and Neck Surgery, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Jason M', 'Initials': 'JM', 'LastName': 'Johnson', 'Affiliation': 'Department of Neuroradiology, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Ryan P', 'Initials': 'RP', 'LastName': 'Goepfert', 'Affiliation': 'Department of Head and Neck Surgery, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Jack', 'Initials': 'J', 'LastName': 'Phan', 'Affiliation': 'Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Yasir Y', 'Initials': 'YY', 'LastName': 'Elamin', 'Affiliation': 'Department of Thoracic/Head and Neck Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Danice K', 'Initials': 'DK', 'LastName': 'Torman', 'Affiliation': 'Department of Thoracic/Head and Neck Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Carla L', 'Initials': 'CL', 'LastName': 'Warneke', 'Affiliation': 'Department of Biostatistics, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Amy C', 'Initials': 'AC', 'LastName': 'Hessel', 'Affiliation': 'Department of Head and Neck Surgery, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Adam S', 'Initials': 'AS', 'LastName': 'Garden', 'Affiliation': 'Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Jeffrey N', 'Initials': 'JN', 'LastName': 'Myers', 'Affiliation': 'Department of Head and Neck Surgery, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Faye M', 'Initials': 'FM', 'LastName': 'Johnson', 'Affiliation': 'Department of Thoracic/Head and Neck Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'J Jack', 'Initials': 'JJ', 'LastName': 'Lee', 'Affiliation': 'Department of Biostatistics, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Andrew G', 'Initials': 'AG', 'LastName': 'Sikora', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Baylor College of Medicine, Houston, Texas.'}, {'ForeName': 'Maura L', 'Initials': 'ML', 'LastName': 'Gillison', 'Affiliation': 'Department of Thoracic/Head and Neck Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Bonnie S', 'Initials': 'BS', 'LastName': 'Glisson', 'Affiliation': 'Department of Thoracic/Head and Neck Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Neil D', 'Initials': 'ND', 'LastName': 'Gross', 'Affiliation': 'Department of Head and Neck Surgery, The University of Texas MD Anderson Cancer Center, Houston, Texas.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-19-3977'] 368,32269170,"Correction: Regular, sustained-release morphine for chronic breathlessness: a multicentre, double-blind, randomised, placebo-controlled trial .",,2020,,['chronic breathlessness'],"['placebo', 'Correction: Regular, sustained-release morphine']",[],"[{'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}]",[],,0.761976,,[],Thorax,['10.1136/thoraxjnl-2019-213681corr1'] 369,32192925,"Titanium-Prepared Platelet-Rich Fibrin Versus Connective Tissue Graft on Peri-Implant Soft Tissue Thickening and Keratinized Mucosa Width: A Randomized, Controlled Trial.","PURPOSE The health of peri-implant tissues is associated with the peri-implant soft tissue thickness (STT) and keratinized tissue width (KTW). Resorptive changes in the crestal bone around implant sites will be affected by the STT. The present randomized prospective study compared the effectiveness of titanium-prepared platelet-rich fibrin (T-PRF) with that of connective tissue graft (CTG) on peri-implant STT, KMW, and crestal bone level. PATIENTS AND METHODS Through simultaneous augmentation of the soft tissue using T-PRF or CTG, 30 implants were placed in 30 patients. The implants were placed in thin, soft tissue areas and thickened simultaneously with a T-PRF membrane in the test group and a CTG in the control group. During surgery (T 0 ) and at 3 months postoperatively (T 1 ), the KTW and peri-implant STT were measured at 3 points: occlusal part of the alveolar crest (OAC), midbuccal mucosa level (MBML), and 1 mm above the mucogingival junction (MGJ1). The crestal bone changes were evaluated from a periapical radiograph at 3 months postoperatively. RESULTS The baseline STT and KTW measurements showed no significant differences between the 2 groups (P < .05). Comparison of the T 0 and T 1 measurements from the 2 groups showed a significant increase in KTW and STT (P < .001). Compared with the test group, the control group showed a highly significant increase in the peri-implant STT at the MBML, MGJ1, and KTW levels (P < .05). No significant difference was found between the 2 groups in terms of the OAC changes (P > .05). No crestal bone loss was observed in any of the dental implants. CONCLUSIONS Both groups experienced a greater increase in peri-implant STT at the OAC level, and T-PRF can be considered as an autogenous alternative to CTG. Also, peri-implant STT might prevent crestal bone resorption in the osseointegration period.",2020,"Both groups experienced a greater increase in peri-implant STT at the OAC level, and T-PRF can be considered as an autogenous alternative to CTG.","['Through simultaneous augmentation of the soft tissue using T-PRF or CTG, 30 implants were placed in 30 patients', 'Peri-Implant Soft Tissue Thickening and Keratinized Mucosa Width']","['Connective Tissue Graft', 'Titanium-Prepared Platelet-Rich Fibrin', 'connective tissue graft (CTG', 'titanium-prepared platelet-rich fibrin (T-PRF']","['peri-implant STT, KMW, and crestal bone level', 'peri-implant STT at the MBML, MGJ1, and KTW levels', 'OAC changes', 'KTW and STT', 'crestal bone resorption', 'baseline STT and KTW measurements', 'crestal bone loss', 'peri-implant STT', 'crestal bone changes']","[{'cui': 'C0521115', 'cui_str': 'Simultaneous (qualifier value)'}, {'cui': 'C1293122', 'cui_str': 'Augmentation procedure'}, {'cui': 'C0225317', 'cui_str': 'Soft tissues (body structure)'}, {'cui': 'C0033374', 'cui_str': 'Prolactin-Releasing Peptide'}, {'cui': 'C2828363', 'cui_str': 'Implant'}, {'cui': 'C1704765', 'cui_str': 'Place - dosing instruction imperative'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C0205400', 'cui_str': 'Thickened (qualifier value)'}, {'cui': 'C0026724', 'cui_str': 'Mucosal Tissue'}, {'cui': 'C0487742', 'cui_str': 'Width (qualifier value)'}]","[{'cui': 'C0009780', 'cui_str': 'Connective Tissue'}, {'cui': 'C1527362', 'cui_str': 'grafts'}, {'cui': 'C0040302', 'cui_str': 'Titanium'}, {'cui': 'C4082130', 'cui_str': 'Prepared (qualifier value)'}, {'cui': 'C4505052', 'cui_str': 'L-PRF'}, {'cui': 'C0033374', 'cui_str': 'Prolactin-Releasing Peptide'}]","[{'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C2828363', 'cui_str': 'Implant'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0005974', 'cui_str': 'Osteoclastic Bone Loss'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0029453', 'cui_str': 'Osteopenia'}]",30.0,0.0285614,"Both groups experienced a greater increase in peri-implant STT at the OAC level, and T-PRF can be considered as an autogenous alternative to CTG.","[{'ForeName': 'Gülbahar', 'Initials': 'G', 'LastName': 'Ustaoğlu', 'Affiliation': 'Assistant Professor, Department of Periodontology, Faculty of Dentistry, Abant Izzet Baysal University, Bolu, Turkey.'}, {'ForeName': 'Tuğçe', 'Initials': 'T', 'LastName': 'Paksoy', 'Affiliation': 'Assistant Professor, Department of Periodontology, Faculty of Dentistry, Beykent University, Istanbul, Turkey. Electronic address: tugcepaksoy@beykent.edu.tr.'}, {'ForeName': 'Kerem Çağlar', 'Initials': 'KÇ', 'LastName': 'Gümüş', 'Affiliation': 'Private Practice in Periodontology, Kocaeli, Turkey.'}]",Journal of oral and maxillofacial surgery : official journal of the American Association of Oral and Maxillofacial Surgeons,['10.1016/j.joms.2020.02.019'] 370,31558416,DASH diet decreases CXCL4 plasma concentration in patients diagnosed with coronary atherosclerotic lesions.,"BACKGROUND AND AIMS Aim of this study involved assessment of the intensive intervention concerning lifestyle based on the DASH diet model on plasma concentration of CXCL4 chemokine among patients with coronary atherosclerosis. METHODS AND RESULTS The Dietary Intervention to Stop Coronary Atherosclerosis in Computed Tomography Study randomized patients with stable CAD to an interventional group (n = 41), where DASH diet was implemented and the control group (n = 40) without dietary intervention. Dietary counselling was provided to DASH group during all 6 control visits within 6 months of observation. During the study, body weight and body composition were controlled using the bioimpedance method. CXCL4 concentration was determined with the use of ELISA test. Within the DASH group, a significant decrease in body weight, a decrease in high sensitivity C-reactive protein concentration (-0.32 ± 2.8 mg/l; p < 0.05), as well as a decrease in CXCL4 concentration (-3.35 ± 3.4 ng/ml; p < 0.0001) were observed. Occurring changes were not statistically significant within the control group. CONCLUSIONS DASH diet lessens CXCL4 concentration among patients with a stable CAD, however, further research is necessary in order to confirm aforementioned results and evaluate the impact on atherosclerotic plaque. THIS TRIAL WAS REGISTERED AT: www.clinicaltrials.gov as NCT02571803.",2020,"Within the DASH group, a significant decrease in body weight, a decrease in high sensitivity C-reactive protein concentration (-0.32 ± ","['patients with coronary atherosclerosis', 'patients with a stable CAD', 'patients diagnosed with coronary atherosclerotic lesions']","['Dietary Intervention', 'DASH diet was implemented and the control group (n\xa0=\xa040) without dietary intervention', 'DASH diet']","['body weight and body composition', 'body weight', 'plasma concentration of CXCL4 chemokine', 'high sensitivity C-reactive protein concentration', 'CXCL4 concentration', 'CXCL4 plasma concentration']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0010054', 'cui_str': 'Coronary Atherosclerosis'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}]","[{'cui': 'C4053458', 'cui_str': 'Dietary Approaches To Stop Hypertension Diet'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0032183', 'cui_str': 'Antiheparin Factor'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}]",,0.0263136,"Within the DASH group, a significant decrease in body weight, a decrease in high sensitivity C-reactive protein concentration (-0.32 ± ","[{'ForeName': 'Magdalena', 'Initials': 'M', 'LastName': 'Makarewicz-Wujec', 'Affiliation': 'Department of Clinical Pharmacy and Pharmaceutical Care, Medical University of Warsaw, Poland. Electronic address: magdalena.wujec@wum.edu.pl.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Henzel', 'Affiliation': 'Department of Coronary and Structural Heart Diseases, Cardinal Stefan Wyszynski Institute of Cardiology, Warsaw, Poland.'}, {'ForeName': 'Mariusz', 'Initials': 'M', 'LastName': 'Kruk', 'Affiliation': 'Department of Coronary and Structural Heart Diseases, Cardinal Stefan Wyszynski Institute of Cardiology, Warsaw, Poland.'}, {'ForeName': 'Cezary', 'Initials': 'C', 'LastName': 'Kępka', 'Affiliation': 'Department of Coronary and Structural Heart Diseases, Cardinal Stefan Wyszynski Institute of Cardiology, Warsaw, Poland.'}, {'ForeName': 'Łukasz', 'Initials': 'Ł', 'LastName': 'Wardziak', 'Affiliation': 'Department of Coronary and Structural Heart Diseases, Cardinal Stefan Wyszynski Institute of Cardiology, Warsaw, Poland.'}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Trochimiuk', 'Affiliation': 'Department of Coronary and Structural Heart Diseases, Cardinal Stefan Wyszynski Institute of Cardiology, Warsaw, Poland.'}, {'ForeName': 'Andrzej', 'Initials': 'A', 'LastName': 'Parzonko', 'Affiliation': 'Department of Pharmacognosy and Molecular Basis of Phytotherapy, Medical University of Warsaw, Poland.'}, {'ForeName': 'Marcin', 'Initials': 'M', 'LastName': 'Demkow', 'Affiliation': 'Department of Coronary and Structural Heart Diseases, Cardinal Stefan Wyszynski Institute of Cardiology, Warsaw, Poland.'}, {'ForeName': 'Małgorzata', 'Initials': 'M', 'LastName': 'Kozłowska-Wojciechowska', 'Affiliation': 'Department of Clinical Pharmacy and Pharmaceutical Care, Medical University of Warsaw, Poland.'}]","Nutrition, metabolism, and cardiovascular diseases : NMCD",['10.1016/j.numecd.2019.07.013'] 371,32150549,Fecal microbiota transplantation for the improvement of metabolism in obesity: The FMT-TRIM double-blind placebo-controlled pilot trial.,"BACKGROUND There is intense interest about whether modulating gut microbiota can impact systemic metabolism. We investigated the safety of weekly oral fecal microbiota transplantation (FMT) capsules from healthy lean donors and their ability to alter gut microbiota and improve metabolic outcomes in patients with obesity. METHODS AND FINDINGS FMT-TRIM was a 12-week double-blind randomized placebo-controlled pilot trial of oral FMT capsules performed at a single US academic medical center. Between August 2016 and April 2018, we randomized 24 adults with obesity and mild-moderate insulin resistance (homeostatic model assessment of insulin resistance [HOMA-IR] between 2.0 and 8.0) to weekly healthy lean donor FMT versus placebo capsules for 6 weeks. The primary outcome, assessed by intention to treat, was change in insulin sensitivity between 0 and 6 weeks as measured by hyperinsulinemic euglycemic clamps. Additional metabolic parameters were evaluated at 0, 6, and 12 weeks, including HbA1c, body weight, body composition by dual-energy X-ray absorptiometry, and resting energy expenditure by indirect calorimetry. Fecal samples were serially collected and evaluated via 16S V4 rRNA sequencing. Our study population was 71% female, with an average baseline BMI of 38.8 ± 6.7 kg/m2 and 41.3 ± 5.1 kg/m2 in the FMT and placebo groups, respectively. There were no statistically significant improvements in insulin sensitivity in the FMT group compared to the placebo group (+5% ± 12% in FMT group versus -3% ± 32% in placebo group, mean difference 9%, 95% CI -5% to 28%, p = 0.16). There were no statistically significant differences between groups for most of the other secondary metabolic outcomes, including HOMA-IR (mean difference 0.2, 95% CI -0.9 to 0.9, p = 0.96) and body composition (lean mass mean difference -0.1 kg, 95% CI -1.9 to 1.6 kg, p = 0.87; fat mass mean difference 1.2 kg, 95% CI -0.6 to 3.0 kg, p = 0.18), over the 12-week study. We observed variable engraftment of donor bacterial groups among FMT recipients, which persisted throughout the 12-week study. There were no significant differences in adverse events (AEs) (10 versus 5, p = 0.09), and no serious AEs related to FMT. Limitations of this pilot study are the small sample size, inclusion of participants with relatively mild insulin resistance, and lack of concurrent dietary intervention. CONCLUSIONS Weekly administration of FMT capsules in adults with obesity results in gut microbiota engraftment in most recipients for at least 12 weeks. Despite engraftment, we did not observe clinically significant metabolic effects during the study. TRIAL REGISTRATION ClinicalTrials.gov NCT02530385.",2020,"There were no significant differences in adverse events (AEs) (10 versus 5, p = 0.09), and no serious AEs related to FMT.","['participants with relatively mild insulin resistance, and lack of concurrent dietary intervention', 'healthy lean donors', 'Between August 2016 and April 2018, we randomized 24 adults with obesity and mild-moderate insulin resistance (homeostatic model assessment of insulin resistance [HOMA-IR] between 2.0 and 8.0) to weekly healthy lean donor', 'patients with obesity', 'obesity', 'Our study population was 71% female, with an average baseline BMI of 38.8 ± 6.7 kg/m2 and 41.3 ± 5.1 kg/m2 in the FMT and placebo groups, respectively', 'FMT-TRIM']","['FMT capsules', 'oral FMT', 'placebo', 'FMT', 'FMT versus placebo', 'oral fecal microbiota transplantation (FMT) capsules', 'Fecal microbiota transplantation']","['hyperinsulinemic euglycemic clamps', 'insulin sensitivity', 'HbA1c, body weight, body composition by dual-energy X-ray absorptiometry, and resting energy expenditure by indirect calorimetry', 'gut microbiota engraftment', 'body composition', 'HOMA-IR', 'adverse events (AEs', 'metabolic outcomes']","[{'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C0332268', 'cui_str': 'Lacking (qualifier value)'}, {'cui': 'C0205420', 'cui_str': 'Concurrent (qualifier value)'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0441645', 'cui_str': 'Trimming - action (qualifier value)'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2242628', 'cui_str': 'Fecal Transplantation'}, {'cui': 'C4319574', 'cui_str': 'Capsule'}]","[{'cui': 'C0079318', 'cui_str': 'Glucose Clamp'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C1510486', 'cui_str': 'Dual X-Ray Absorptiometry'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0014272', 'cui_str': 'Energy Expenditure'}, {'cui': 'C0006781', 'cui_str': 'Calorimetry, Respiration'}, {'cui': 'C4018878', 'cui_str': 'Gastrointestinal Microbial Community'}, {'cui': 'C0301944', 'cui_str': 'Graft acceptance (finding)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",24.0,0.712521,"There were no significant differences in adverse events (AEs) (10 versus 5, p = 0.09), and no serious AEs related to FMT.","[{'ForeName': 'Elaine W', 'Initials': 'EW', 'LastName': 'Yu', 'Affiliation': 'Endocrine Unit, Division of Endocrinology and Metabolism, Massachusetts General Hospital, Boston, Massachusetts, United States of America.'}, {'ForeName': 'Liu', 'Initials': 'L', 'LastName': 'Gao', 'Affiliation': 'Endocrine Unit, Division of Endocrinology and Metabolism, Massachusetts General Hospital, Boston, Massachusetts, United States of America.'}, {'ForeName': 'Petr', 'Initials': 'P', 'LastName': 'Stastka', 'Affiliation': 'Endocrine Unit, Division of Endocrinology and Metabolism, Massachusetts General Hospital, Boston, Massachusetts, United States of America.'}, {'ForeName': 'Michael C', 'Initials': 'MC', 'LastName': 'Cheney', 'Affiliation': 'Endocrine Unit, Division of Endocrinology and Metabolism, Massachusetts General Hospital, Boston, Massachusetts, United States of America.'}, {'ForeName': 'Jasmin', 'Initials': 'J', 'LastName': 'Mahabamunuge', 'Affiliation': 'Division of Infectious Diseases, Massachusetts General Hospital, Boston, Massachusetts, United States of America.'}, {'ForeName': 'Mariam', 'Initials': 'M', 'LastName': 'Torres Soto', 'Affiliation': 'Division of Infectious Diseases, Massachusetts General Hospital, Boston, Massachusetts, United States of America.'}, {'ForeName': 'Christopher B', 'Initials': 'CB', 'LastName': 'Ford', 'Affiliation': 'Seres Therapeutics, Cambridge, Massachusetts, United States of America.'}, {'ForeName': 'Jessica A', 'Initials': 'JA', 'LastName': 'Bryant', 'Affiliation': 'Seres Therapeutics, Cambridge, Massachusetts, United States of America.'}, {'ForeName': 'Matthew R', 'Initials': 'MR', 'LastName': 'Henn', 'Affiliation': 'Seres Therapeutics, Cambridge, Massachusetts, United States of America.'}, {'ForeName': 'Elizabeth L', 'Initials': 'EL', 'LastName': 'Hohmann', 'Affiliation': 'Harvard Medical School, Boston, Massachusetts, United States of America.'}]",PLoS medicine,['10.1371/journal.pmed.1003051'] 372,30613000,Factors Associated With Efficacy of Cognitive Behavior Therapy vs Education for Patients With Irritable Bowel Syndrome.,"BACKGROUND & AIMS Among patients with irritable bowel syndrome (IBS), it would be helpful to identify those most likely to respond to specific treatments, yet few factors have been identified that reliably predict positive outcome. We sought to identify pretreatment baseline characteristics that associate with gastrointestinal symptom improvement in patients who received empirically validated regimens of cognitive behavior therapy (CBT) or IBS education. METHODS We analyzed data from the IBS Outcome Study, in which 436 patients with IBS (average age, 41 years; 80%, female) were randomly assigned to groups that received 4 or 10 sessions of cognitive behavior therapy or education over 10 weeks. Baseline data were collected from all participants on sociodemographic and clinical features and comorbidities. Interaction analyses used a modified linear probability model with Huber-White robust estimators to identify baseline factors that moderated as a function of treatment condition GI symptom improvement based on the IBS-version of the Clinical Global Impressions-Improvement Scale. RESULTS Whether the primary outcome of IBS symptom improvement was rated by patients or physician assessors blind to treatment 2 weeks after it ended, higher percentages of patients had symptom improvement after CBT compared with EDU among those with low levels of trait anxiety (71.3% vs 34.9%; P < .05) or anxiety sensitivity (71.7% vs 38.6%; P < .05) and for those with baseline typical levels of trait anxiety (66.0% vs 47.1%; P < .05) or anxiety sensitivity (66.3% vs 47.1%; P < .05). For patients with high trait anxiety or anxiety sensitivity, the difference in percentage of responders to CBT vs EDU was non-significant for trait anxiety (60.6% vs 59.2%) and anxiety sensitivity (60.9% vs 55.9%). If patients scored at or below 22 on the Trait Anxiety Inventory, CBT had a statistically significant advantage over EDU. If patients scored at or below 29 on the Anxiety Sensitivity Inventory, there was a statistically significant advantage for CBT vs EDU. CONCLUSIONS In analyses of outcomes of patients with treatment-refractory IBS, baseline levels of trait anxiety and anxiety sensitivity (fear of arousal symptoms) were associated with improved gastrointestinal symptoms following CBT compared to IBS education. These findings and approaches might be used to optimize selection of treatment for patients with IBS.",2019,"If patients scored at or below 22 on the Trait Anxiety Inventory, CBT had a statistically significant advantage over EDU.","['patients who received empirically validated regimens of cognitive behavior therapy (CBT) or IBS education', 'patients with IBS', '436 patients with IBS (average age, 41\xa0years; 80%, female', 'patients with irritable bowel syndrome (IBS', 'Patients With Irritable Bowel\xa0Syndrome']","['cognitive behavior therapy or education over 10 weeks', 'Cognitive Behavior Therapy vs Education']","['trait anxiety', 'gastrointestinal symptoms', 'anxiety sensitivity', 'trait anxiety and anxiety sensitivity (fear of arousal symptoms', 'trait anxiety or anxiety sensitivity', 'IBS symptom improvement']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0022104', 'cui_str': 'Irritable Bowel Syndrome'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",436.0,0.0709497,"If patients scored at or below 22 on the Trait Anxiety Inventory, CBT had a statistically significant advantage over EDU.","[{'ForeName': 'Jeffrey M', 'Initials': 'JM', 'LastName': 'Lackner', 'Affiliation': 'Divisions of Behavioral Medicine and Gastroenterology, Department of Medicine, Jacobs School of Medicine, University at Buffalo, Buffalo, New York. Electronic address: lackner@buffalo.edu.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Jaccard', 'Affiliation': 'School of Social Work, New York University, New York, New York.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association,['10.1016/j.cgh.2018.10.033'] 373,32236116,Glycemic effect of post-meal walking compared to one prandial insulin injection in type 2 diabetic patients treated with basal insulin: A randomized controlled cross-over study.,"Studies demonstrate that post-meal walking decreases postprandial hyperglycemia in type 2 diabetic patients but it has never been tested with the active treatment comparator. The objective of this study was to determine the effect of post-meal walking on glycemic control compared with one prandial insulin in type 2 diabetic patients who failed basal insulin. A randomized controlled cross-over study of post-meal walking or one prandial insulin was done in type 2 diabetic patients who were being treated with basal insulin between May 2017 and March 2018. In post-meal walking group, patients walked after meal for 15-20 minutes one meal a day every day for 6 weeks. In prandial insulin (basal plus) group, one prandial insulin was injected before breakfast or main meal with rapid-acting insulin. The primary outcome was a difference in HbA1c reduction in post-meal walking compared with basal plus groups. Fourteen patients completed the study. By intention-to-treat analysis, HbA1c was reduced by -0.05(range:-1.08 to 0.74) and -0.19(range:-0.8 to 0.56) % in post-meal walking and basal plus groups respectively. By per-protocol analysis, post-meal walking and basal plus groups decreased HbA1c by 0.13(range:-0.74 to 1.08) and 0.2(range:-0.56 to 0.8) %, respectively. There was were no significant differences in HbA1c reduction from baseline in each group and between groups in both intention-to-treat and per-protocol analysis. Fructosamine levels were decreased by 17.5(-59 to 43) and 10(-15 to 40) μmol/L, respectively at 3 and 6 weeks in post-meal walking group whereas the respective changes in basal plus group were 12.5(-17 to 64) and 17.5(-28 to 38) μmol/L and there were no significant differences in fructosamine reduction from baseline in each group and between groups. In conclusion, although post-meal walking might be as effective as one prandial insulin to improve glycemic control in type 2 diabetic patients who failed basal insulin but the magnitude of reduction was small. A longer-term study with a larger sample size or with a different walking protocol is required.",2020,There was were no significant differences in HbA1c reduction from baseline in each group and between groups in both intention-to-treat and per-protocol analysis.,"['type 2 diabetic patients treated with basal insulin', 'type 2 diabetic patients who were being treated with basal insulin between May 2017 and March 2018', 'type 2 diabetic patients who failed basal insulin', 'Fourteen patients completed the study', 'type 2 diabetic patients']","['prandial insulin (basal plus) group, one prandial insulin was injected before breakfast or main meal with rapid-acting insulin', 'prandial insulin injection', 'post-meal walking', 'post-meal walking or one prandial insulin']","['Glycemic effect', 'postprandial hyperglycemia', 'fructosamine reduction', 'Fructosamine levels', 'HbA1c reduction']","[{'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1720154', 'cui_str': 'Inject'}, {'cui': 'C1549040', 'cui_str': 'Before breakfast'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0199782', 'cui_str': 'Administration of insulin'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0080331', 'cui_str': 'Walking'}]","[{'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C1855520', 'cui_str': 'Postprandial Hyperglycemia'}, {'cui': 'C0060765', 'cui_str': 'Fructosamine'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}]",,0.0623641,There was were no significant differences in HbA1c reduction from baseline in each group and between groups in both intention-to-treat and per-protocol analysis.,"[{'ForeName': 'Onnicha', 'Initials': 'O', 'LastName': 'Suntornlohanakul', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Chatvara', 'Initials': 'C', 'LastName': 'Areevut', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Sunee', 'Initials': 'S', 'LastName': 'Saetung', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Atiporn', 'Initials': 'A', 'LastName': 'Ingsathit', 'Affiliation': 'Division of Nephrology, Department of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Chatchalit', 'Initials': 'C', 'LastName': 'Rattarasarn', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand.'}]",PloS one,['10.1371/journal.pone.0230554'] 374,32025843,Impact of oral carbohydrate consumption prior to cesarean delivery on preoperative well-being: a randomized interventional study.,"PURPOSE Oral carbohydrate consumption before surgery improves insulin sensitivity, cardiac output and well-being, and shortens hospital stays without adverse effects. No work has compared higher-dose carbohydrate beverages made for preoperative consumption to common, commercial oral rehydration solutions with lower carbohydrate concentrations. METHODS We recruited low-risk women undergoing scheduled cesarean deliveries with planned spinal anesthesia. Participants were randomized to one of three groups: those who consumed Clearfast ® beverage, those who consumed Gatorade Thirst Quencher ® beverage, or fasting control. Participants in the two beverage groups received 710 mL of the appropriate beverage the night before surgery and 355 mL 2 h before surgery. Participants in the control group fasted after midnight the night before surgery. Two hours before surgery, we recorded baseline patient well-being using visual analogue scales, followed by beverage consumption for subjects in the beverage groups. One hour later, we repeated the same assessment. Additional recorded measures included cord blood glucose level, intraoperative variables, breastfeeding success, and a quality of recovery assessment administered 1 day after surgery. RESULTS Forty-seven patients were recruited: 15 received Clearfast ® , 17 received Gatorade Thirst Quencher ® , and 15 patients fasted after midnight. Group differences in change in patient well-being using visual analog scales were analyzed using linear regression. Both beverage-consuming groups showed significant improvements in patient well-being using visual analog scales while fasted patients showed no change. CONCLUSION Either a common oral rehydration beverage or a higher-dose carbohydrate beverage consumed preoperatively resulted in superior well-being compared to fasting. No differences in other outcomes were noted. TRIAL REGISTRATION This study was registered on ClinicalTrials.gov with clinical trial registration number: NCT02684513.",2020,"Both beverage-consuming groups showed significant improvements in patient well-being using visual analog scales while fasted patients showed no change. ","['Forty-seven patients were recruited: 15 received', 'low-risk women undergoing scheduled cesarean deliveries with planned spinal anesthesia']","['consumed Clearfast ® beverage, those who consumed Gatorade Thirst Quencher ® beverage, or fasting control', 'Clearfast ®', '710\xa0mL of the appropriate beverage the night before surgery and 355', 'oral carbohydrate consumption']","['insulin sensitivity, cardiac output and well-being, and shortens hospital stays without adverse effects', 'cord blood glucose level, intraoperative variables, breastfeeding success, and a quality of recovery assessment administered 1\xa0day after surgery', 'patient well-being using visual analog scales']","[{'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3538919', 'cui_str': 'Low risk (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C1384674', 'cui_str': 'Deliveries by cesarean (finding)'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C0002928', 'cui_str': 'Spinal Anesthesia'}]","[{'cui': 'C0005329', 'cui_str': 'Beverages'}, {'cui': 'C0206948', 'cui_str': 'gatorade'}, {'cui': 'C0039971', 'cui_str': 'Thirst'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]","[{'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0007165', 'cui_str': 'Cardiac Output'}, {'cui': 'C1282927', 'cui_str': 'Shortened (qualifier value)'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0162371', 'cui_str': 'Cord Blood'}, {'cui': 'C0428548', 'cui_str': 'Glucose level - finding'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C1623040', 'cui_str': 'Breastfeeding (mother)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}]",47.0,0.406642,"Both beverage-consuming groups showed significant improvements in patient well-being using visual analog scales while fasted patients showed no change. ","[{'ForeName': 'Adam L', 'Initials': 'AL', 'LastName': 'Wendling', 'Affiliation': 'Department of Anesthesiology, University of Florida College of Medicine, 1600 SW Archer Road, PO Box 100254, Gainesville, FL, 32610, USA. awendling@anest.ufl.edu.'}, {'ForeName': 'Sharon Y', 'Initials': 'SY', 'LastName': 'Byun', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Florida College of Medicine, Gainesville, FL, USA.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Koenig', 'Affiliation': 'Department of Anesthesiology, University of Florida College of Medicine, 1600 SW Archer Road, PO Box 100254, Gainesville, FL, 32610, USA.'}, {'ForeName': 'Terrie', 'Initials': 'T', 'LastName': 'Vasilopoulos', 'Affiliation': 'Departments of Anesthesiology and Orthopedics, University of Florida College of Medicine, Gainesville, FL, USA.'}]",Archives of gynecology and obstetrics,['10.1007/s00404-020-05455-z'] 375,32268799,Comparison of Message and Effects Perceptions for The Real Cost E-Cigarette Prevention Ads.,"Perceived message effectiveness (PME) is commonly used in health communication research and practice, yet there has been a dearth of studies comparing different operationalizations of the PME construct. In the present study, we compared the two major types of PME - message perceptions and effects perceptions - among N = 557 young adults. Participants were randomized to one of two conditions: 1) The Real Cost e-cigarette prevention ads developed by the Food and Drug Administration (FDA condition) or 2) information-only e-cigarette control ads developed by the Mayo Clinic (control ad condition). Study predictors were message and effects perceptions measures and actual message effectiveness (AME) outcomes were risk beliefs about vaping and intentions to vape. Results showed that both message perceptions ( M = 3.82 vs M = 3.29; p < .001) and effects perceptions ( M = 4.13 vs M = 3.82; p < .001) were higher in the FDA ad condition compared to control. Risk beliefs about vaping were also higher in the FDA ad condition than control ( M = 3.95 vs M = 3.79; p =.022), but we found no differences in participants' intentions to vape, which were low overall ( M = 1.59 in FDA vs M = 1.58 in control). In multivariate analyses adjusting for covariates and including both types of PME, only effects perceptions (not message perceptions) were associated with risk beliefs about vaping ( b =.37, p < .001) and intentions to vape ( b = -.26, p < .001). Our findings advance PME research by demonstrating the differing nature of message and effects perceptions, and suggest that effects perceptions should be utilized during message pretesting.",2020,Results showed that both message perceptions ( M = 3.82 vs M = 3.29; p < .001) and effects perceptions ( M = 4.13 vs M = 3.82; ,['557 young adults'],['Real Cost e-cigarette prevention ads developed by the Food and Drug Administration (FDA condition) or 2) information-only e-cigarette control ads developed by the Mayo Clinic (control ad condition'],"['message and effects perceptions measures and actual message effectiveness', 'risk beliefs about vaping and intentions to vape']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C3849993', 'cui_str': 'Electronic cigarette'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0041714', 'cui_str': 'United States Food, Drug Administration'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0454788', 'cui_str': 'Mayo'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}]","[{'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C4083280', 'cui_str': 'Vape'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0291011', 'cui_str': 'VAPE protocol'}]",557.0,0.0319582,Results showed that both message perceptions ( M = 3.82 vs M = 3.29; p < .001) and effects perceptions ( M = 4.13 vs M = 3.82; ,"[{'ForeName': 'Jacob A', 'Initials': 'JA', 'LastName': 'Rohde', 'Affiliation': 'Hussman School of Journalism and Media, University of North Carolina.'}, {'ForeName': 'Seth M', 'Initials': 'SM', 'LastName': 'Noar', 'Affiliation': 'Hussman School of Journalism and Media, University of North Carolina.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Prentice-Dunn', 'Affiliation': 'Lineberger Comprehensive Cancer Center, University of North Carolina.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Kresovich', 'Affiliation': 'Hussman School of Journalism and Media, University of North Carolina.'}, {'ForeName': 'Marissa G', 'Initials': 'MG', 'LastName': 'Hall', 'Affiliation': 'Lineberger Comprehensive Cancer Center, University of North Carolina.'}]",Health communication,['10.1080/10410236.2020.1749353'] 376,32188326,Healthcare resource utilization in a phase 3 study of CPX-351 in patients with newly diagnosed high-risk/secondary acute myeloid leukemia.,"Aims: Treatment of acute myeloid leukemia (AML) requires significant healthcare resource utilization (HRU), including lengthy hospitalizations. In a phase 3 study (NCT01696084), CPX-351 (Vyxeos) showed significant benefits to overall survival and complete remission versus conventional 7 + 3 cytarabine/daunorubicin. This analysis evaluated HRU in patients aged 60-75 years with newly diagnosed high-risk/secondary AML treated with CPX-351 versus 7 + 3 in the phase 3 study. Materials and methods: Patients were randomized to receive up to two induction cycles with CPX-351 or 7 + 3. Responders could receive up to two cycles of consolidation. To normalize HRU to length of treatment, patients were assessed on a per patient-year (PPY) basis. HRU analyses included hospital and intensive care unit (ICU) stays, anti-infective use, transfusions, and white blood cell colony-stimulating factor (CSF). Results: The median (range) total duration of hospitalization was 39 (3-110) days with CPX-351 ( n  = 153) and 32 (2-83) days with 7 + 3 ( n  = 151); the estimated durations of hospitalization PPY were 198.4 and 240.5 days, respectively. The median (range) total duration of ICU stays was 0 (0-45) days with CPX-351 and 0 (0-17) days with 7 + 3; the estimated durations of ICU stays PPY were 6.7 and 10.5 days, respectively. When comparing supportive care use during CPX-351 and 7 + 3 treatment, the estimated number PPY of bags of platelets used (24.6 vs 26.9, respectively), bags of packed red blood cells used (13.0 vs 13.9), days of anti-infectives (162.0 vs 159.2), and days of CSF (4.0 vs 2.4) were not notably different. Limitations: This clinical study analysis may not represent real-world HRU patterns or be generalizable to a broader AML population. Conclusions: These PPY data, showing shorter durations of hospitalization and similar use of supportive care with CPX-351 versus 7 + 3, suggest CPX-351 is not associated with increased HRU in older patients with newly diagnosed high-risk/secondary AML.",2020,"The median (range) total duration of hospitalization was 39 (3-110) days with CPX-351 (n = 153) and 32 (2-83) days with 7 + 3 (n = 151); the estimated durations of hospitalization PPY were 198.4 and 240.5 days, respectively.","['patients with newly diagnosed high-risk/secondary acute myeloid leukemia', 'acute myeloid leukemia (AML', 'patients aged 60-75 years with newly diagnosed high-risk/secondary AML treated with CPX-351 versus 7\u2009+\u20093 in the phase 3 study', 'older patients with newly diagnosed high-risk/secondary AML']","['cytarabine/daunorubicin', 'CPX-351 (Vyxeos®', 'CPX-351', 'CPX-351 or 7\u2009+\u20093']","['durations of ICU stays PPY', 'hospital and intensive care unit (ICU) stays, anti-infective use, transfusions, and white blood cell colony stimulating factor (CSF', 'overall survival and complete remission', 'estimated durations of hospitalization PPY', 'median (range) total duration of ICU stays', 'median (range) total duration of hospitalization']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0023467', 'cui_str': 'Nonlymphoblastic Leukemia, Acute'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0439561', 'cui_str': 'Phase 3 (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C0010711', 'cui_str': 'Cytarabine'}, {'cui': 'C0011015', 'cui_str': 'Daunorubicin'}, {'cui': 'C4520103', 'cui_str': 'Vyxeos'}]","[{'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0003204', 'cui_str': 'Antiinfective Agents'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0199960', 'cui_str': 'Transfusion - action (qualifier value)'}, {'cui': 'C0023516', 'cui_str': 'Blood Corpuscles, White'}, {'cui': 'C0439158', 'cui_str': 'colonies (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]",,0.0565637,"The median (range) total duration of hospitalization was 39 (3-110) days with CPX-351 (n = 153) and 32 (2-83) days with 7 + 3 (n = 151); the estimated durations of hospitalization PPY were 198.4 and 240.5 days, respectively.","[{'ForeName': 'Kathleen F', 'Initials': 'KF', 'LastName': 'Villa', 'Affiliation': 'Health Economics & Outcomes Research, Jazz Pharmaceuticals, Palo Alto, CA, USA.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Ryan', 'Affiliation': 'Biostatistics, Jazz Pharmaceuticals, Philadelphia, PA, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Chiarella', 'Affiliation': 'Clinical Development, Jazz Pharmaceuticals, Palo Alto, CA, USA.'}, {'ForeName': 'Arthur C', 'Initials': 'AC', 'LastName': 'Louie', 'Affiliation': 'Clinical Development, Jazz Pharmaceuticals, Palo Alto, CA, USA.'}]",Journal of medical economics,['10.1080/13696998.2020.1744613'] 377,32189446,Simulation in Urological Training and Education (SIMULATE): Protocol and curriculum development of the first multicentre international randomized controlled trial assessing the transferability of simulation-based surgical training.,"OBJECTIVES To report the study protocol for the first international multicentre randomized controlled trial investigating the effectiveness of simulation-based surgical training and the development process for an evidence-based training curriculum, to be delivered as an educational intervention. PARTICIPANTS AND METHODS This prospective, international, multicentre randomized controlled clinical and educational trial will recruit urology surgical trainees who must not have performed ≥10 of the selected index procedure, ureterorenoscopy (URS). Participants will be randomized to simulation-based training (SBT) or non-simulation-based training (NSBT), the latter of which is the current sole standard of training globally. The primary outcome is the number of procedures required to achieve proficiency, where proficiency is defined as achieving a learning curve plateau of 28 or more on an Objective Structured Assessment of Technical Skills (OSATS) assessment scale, for three consecutive operations, without any complications. All participants will be followed up either until they complete 25 procedures or for 18 months. Development of the URS SBT curriculum took place through a two-round Delphi process. RESULTS A total of 47 respondents, consisting of trainees (n = 24) with URS experience and urolithiasis specialists (n = 23), participated in round 1 of the Delphi process. Specialists (n = 10) finalized the content of the curriculum in round 2. The developed interventional curriculum consists of initial theoretic knowledge through didactic lectures followed by select tasks and cases on the URO-Mentor (Simbionix, Lod, Israel) VR Simulator, Uro-Scopic Trainer (Limbs & Things, Bristol, UK) and Scope Trainer (Mediskills, Manchester, UK) models for both semi-rigid and flexible URS. Respondents also selected relevant non-technical skills scenarios and cadaveric simulation tasks as additional components, with delivery subject to local availability. CONCLUSIONS SIMULATE is the first multicentre trial investigating the effect and transferability of supplementary SBT on operating performance and patient outcomes. An evidence-based training curriculum is presented, developed with expert and trainee input. Participants will be followed and the primary outcome, number of procedures required to proficiency, will be reported alongside key clinical secondary outcomes, (ISCRTN 12260261).",2020,"Participants will be randomised to simulation-based training (SBT) or non-simulation-based training (NSBT), the latter of which is the current sole standard of training globally.","['47 respondents consisting of trainees (n=24), with URS experience, and urolithiasis specialists (n=23) participated in round-1 of the Delphi process', 'Surgery', 'urology surgical trainees who must not have performed ≥ 10 of the selected index procedure, ureterorenoscopy (URS']","['Transferability of Simulation-based Training', 'simulation-based surgical training', 'simulation-based training (SBT) or non-simulation-based training (NSBT']","['number of procedures required to achieve proficiency, where proficiency is defined as achieving a learning curve plateau of 28 or more on an Objective Structured Assessment of Technical Skill (OSATS) assessment scale, on 3 consecutive operations, without any complications']","[{'cui': 'C0282122', 'cui_str': 'Respondents'}, {'cui': 'C0451641', 'cui_str': 'Urinary Lithiasis'}, {'cui': 'C0087009', 'cui_str': 'Specialists'}, {'cui': 'C4521054', 'cui_str': 'Process (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0042077', 'cui_str': 'Urology'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C1270970', 'cui_str': 'Ureterorenoscopy (procedure)'}]","[{'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C2936637', 'cui_str': 'Learning Curve'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales (assessment scale)'}, {'cui': 'C0038895', 'cui_str': 'operative therapy'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}]",,0.182342,"Participants will be randomised to simulation-based training (SBT) or non-simulation-based training (NSBT), the latter of which is the current sole standard of training globally.","[{'ForeName': 'Abdullatif', 'Initials': 'A', 'LastName': 'Aydin', 'Affiliation': ""MRC Centre for Transplantation, King's College London, London, UK.""}, {'ForeName': 'Kamran', 'Initials': 'K', 'LastName': 'Ahmed', 'Affiliation': ""MRC Centre for Transplantation, King's College London, London, UK.""}, {'ForeName': 'Mieke', 'Initials': 'M', 'LastName': 'Van Hemelrijck', 'Affiliation': ""School of Cancer and Pharmaceutical Studies, King's College London, London, UK.""}, {'ForeName': 'Hashim U', 'Initials': 'HU', 'LastName': 'Ahmed', 'Affiliation': 'Department of Surgery and Cancer, Imperial College London, UK.'}, {'ForeName': 'Muhammad Shamim', 'Initials': 'MS', 'LastName': 'Khan', 'Affiliation': ""MRC Centre for Transplantation, King's College London, London, UK.""}, {'ForeName': 'Prokar', 'Initials': 'P', 'LastName': 'Dasgupta', 'Affiliation': ""MRC Centre for Transplantation, King's College London, London, UK.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BJU international,['10.1111/bju.15056'] 378,31173362,"Overall survival and histology-specific subgroup analyses from a phase 3, randomized controlled study of trabectedin or dacarbazine in patients with advanced liposarcoma or leiomyosarcoma.","BACKGROUND We performed a randomized phase 3 study of trabectedin versus dacarbazine in previously-treated patients with liposarcoma/leiomyosarcoma (LPS/LMS). METHODS Patients were randomized 2:1 to trabectedin (n = 384) or dacarbazine (n = 193) administered intravenously every 3 weeks. The primary objective was overall survival (OS). Secondary objectives were progression-free survival, objective response rate, safety, and patient-reported outcomes, all previously reported and demonstrating superior disease control with trabectedin. Results of the final OS analysis in preplanned subgroups of patients with LPS/LMS are presented. RESULTS At the time of the final OS analysis, 577 patients had been assigned randomly, including 423 (73%) with LMS and 154 (27%) with LPS. The median duration of treatment exposure was higher in the trabectedin arm compared with the dacarbazine arm (4 vs 2 cycles), as was the proportion of patients receiving an extended number of therapy courses (≥6 cycles: 42% vs 22%). This pattern was consistent across histological subgroups: the median number of treatment cycles (4 vs 2 for both subgroups) and proportion of patients with ≥6 treatment cycles (LMS, 43% vs 24%; LPS, 40% vs 16%). Despite improved disease control by trabectedin, no improvement in OS was observed; the final median OS for trabectedin versus dacarbazine was 13.7 versus 13.1 months (P = .49). Sensitivity analyses of OS suggest confounding by post-study anticancer therapies, which were utilized in most patients in both treatment arms (71% vs 69%, respectively). CONCLUSION The final OS results demonstrated comparable survival between LPS/LMS patients receiving trabectedin or dacarbazine, which is consistent with the interim analysis results. Both LPS and LMS demonstrated improved disease control with trabectedin.",2019,"Despite improved disease control by trabectedin, no improvement in OS was observed; the final median OS for trabectedin versus dacarbazine was 13.7 versus 13.1 months (P = .49).","['Patients', 'previously-treated patients with liposarcoma/leiomyosarcoma (LPS/LMS', 'patients with advanced liposarcoma or leiomyosarcoma']","['LPS and LMS', 'dacarbazine', 'trabectedin versus dacarbazine', 'trabectedin', 'trabectedin or dacarbazine']","['survival', 'OS', 'progression-free survival, objective response rate, safety, and patient-reported outcomes', 'overall survival (OS', 'Overall survival', 'final median OS', 'median duration of treatment exposure']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0023827', 'cui_str': 'Liposarcoma (disorder)'}, {'cui': 'C0023269', 'cui_str': 'LMS - Leiomyosarcoma'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}]","[{'cui': 'C0010927', 'cui_str': 'Dacarbazine'}, {'cui': 'C1311070', 'cui_str': 'trabectedin'}]","[{'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0444921', 'cui_str': 'Duration of treatment (qualifier value)'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}]",577.0,0.194281,"Despite improved disease control by trabectedin, no improvement in OS was observed; the final median OS for trabectedin versus dacarbazine was 13.7 versus 13.1 months (P = .49).","[{'ForeName': 'Shreyaskumar', 'Initials': 'S', 'LastName': 'Patel', 'Affiliation': 'The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'von Mehren', 'Affiliation': 'Fox Chase Cancer Center, Philadelphia, Pennsylvania.'}, {'ForeName': 'Damon R', 'Initials': 'DR', 'LastName': 'Reed', 'Affiliation': 'Moffitt Cancer Center, Tampa, Florida.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Kaiser', 'Affiliation': 'Lutheran General Advanced Care Center, Park Ridge, Illinois.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Charlson', 'Affiliation': 'Medical College of Wisconsin, Milwaukee, Wisconsin.'}, {'ForeName': 'Christopher W', 'Initials': 'CW', 'LastName': 'Ryan', 'Affiliation': 'Knight Cancer Institute, Oregon Health and Science University, Portland, Oregon.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Rushing', 'Affiliation': 'Simon Cancer Center, Indiana University, Indianapolis, Indiana.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Livingston', 'Affiliation': 'Blumenthal Cancer Center, Carolinas HealthCare System, Charlotte, North Carolina.'}, {'ForeName': 'Arun', 'Initials': 'A', 'LastName': 'Singh', 'Affiliation': 'UCLA Medical Center, Los Angeles, California.'}, {'ForeName': 'Rahul', 'Initials': 'R', 'LastName': 'Seth', 'Affiliation': 'SUNY Upstate University Hospital, Syracuse, New York.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Forscher', 'Affiliation': 'Cedars-Sinai Medical Center, Los Angeles, California.'}, {'ForeName': 'Gina', 'Initials': 'G', 'LastName': ""D'Amato"", 'Affiliation': 'Georgia Cancer Specialists, Northside Hospital Cancer Institute, Atlanta, Georgia.'}, {'ForeName': 'Sant P', 'Initials': 'SP', 'LastName': 'Chawla', 'Affiliation': 'Sarcoma Oncology Center, Santa Monica, California.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'McCarthy', 'Affiliation': 'Janssen Research & Development, LLC, Raritan, New Jersey.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Wang', 'Affiliation': 'Janssen Research & Development, LLC, Raritan, New Jersey.'}, {'ForeName': 'Trilok', 'Initials': 'T', 'LastName': 'Parekh', 'Affiliation': 'Janssen Research & Development, LLC, Raritan, New Jersey.'}, {'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Knoblauch', 'Affiliation': 'Janssen Research & Development, LLC, Raritan, New Jersey.'}, {'ForeName': 'Martee L', 'Initials': 'ML', 'LastName': 'Hensley', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Robert G', 'Initials': 'RG', 'LastName': 'Maki', 'Affiliation': 'Mount Sinai Medical Center, New York, New York.'}, {'ForeName': 'George D', 'Initials': 'GD', 'LastName': 'Demetri', 'Affiliation': 'Center for Sarcoma and Bone Oncology, Dana-Farber Cancer Institute and Ludwig Center at Harvard, Harvard Medical School, Boston, Massachusetts.'}]",Cancer,['10.1002/cncr.32117'] 379,29801011,Effect of Intravesical Instillation of Gemcitabine vs Saline Immediately Following Resection of Suspected Low-Grade Non-Muscle-Invasive Bladder Cancer on Tumor Recurrence: SWOG S0337 Randomized Clinical Trial.,"Importance Low-grade non-muscle-invasive urothelial cancer frequently recurs after excision by transurethral resection of bladder tumor (TURBT). Objective To determine whether immediate post-TURBT intravesical instillation of gemcitabine reduces recurrence of suspected low-grade non-muscle-invasive urothelial cancer compared with saline. Design, Setting, and Participants Randomized double-blind clinical trial conducted at 23 US centers. Patients with suspected low-grade non-muscle-invasive urothelial cancer based on cystoscopic appearance without any high-grade or without more than 2 low-grade urothelial cancer episodes within 18 months before index TURBT were enrolled between January 23, 2008, and August 14, 2012, and followed up every 3 months with cystoscopy and cytology for 2 years and then semiannually for 2 years. Patients were monitored for tumor recurrence, progression to muscle invasion, survival, and toxic effects. The final date of follow-up was August 14, 2016. Interventions Participants were randomly assigned to receive intravesical instillation of gemcitabine (2 g in 100 mL of saline) (n = 201) or saline (100 mL) (n = 205) for 1 hour immediately following TURBT. Main Outcomes and Measures The primary outcome was time to recurrence of cancer. Secondary end points were time to muscle invasion and death due to any cause. Results Among 406 randomized eligible patients (median age, 66 years; 84.7% men), 383 completed the trial. In the intention-to-treat analysis, 67 of 201 patients (4-year estimate, 35%) in the gemcitabine group and 91 of 205 patients (4-year estimate, 47%) in the saline group had cancer recurrence within 4.0 years (hazard ratio, 0.66; 95% CI, 0.48-0.90; P<.001 by 1-sided log-rank test for time to recurrence). Among the 215 patients with low-grade non-muscle-invasive urothelial cancer who underwent TURBT and drug instillation, 34 of 102 patients (4-year estimate, 34%) in the gemcitabine group and 59 of 113 patients (4-year estimate, 54%) in the saline group had cancer recurrence (hazard ratio, 0.53; 95% CI, 0.35-0.81; P = .001 by 1-sided log-rank test for time to recurrence). Fifteen patients had tumors that progressed to muscle invasion (5 in the gemcitabine group and 10 in the saline group; P = .22 by 1-sided log-rank test) and 42 died of any cause (17 in the gemcitabine group and 25 in the saline group; P = .12 by 1-sided log-rank test). There were no grade 4 or 5 adverse events and no significant differences in adverse events of grade 3 or lower. Conclusions and Relevance Among patients with suspected low-grade non-muscle-invasive urothelial cancer, immediate postresection intravesical instillation of gemcitabine, compared with instillation of saline, significantly reduced the risk of recurrence over a median of 4.0 years. These findings support using this therapy, but further research is needed to compare gemcitabine with other intravesical agents. Trial Registration clinicaltrials.gov Identifier: NCT00445601.",2018,"There were no grade 4 or 5 adverse events and no significant differences in adverse events of grade 3 or lower. ","['Patients with suspected low-grade non-muscle-invasive urothelial cancer based on cystoscopic appearance without any high-grade or without more than 2 low-grade urothelial cancer episodes within 18 months before index TURBT were enrolled between January 23, 2008, and August 14, 2012, and followed up every 3 months with cystoscopy and cytology for 2 years and then semiannually for 2 years', 'Tumor Recurrence', 'suspected low-grade non-muscle-invasive urothelial cancer', 'patients with suspected low-grade non-muscle-invasive urothelial cancer', '406 randomized eligible patients (median age, 66 years; 84.7% men', '215 patients with low-grade non-muscle-invasive urothelial cancer']","['Gemcitabine vs Saline', 'gemcitabine', 'intravesical instillation of gemcitabine (2 g in 100 mL of saline', 'saline']","['time to muscle invasion and death due to any cause', 'adverse events', 'time to recurrence of cancer', 'tumor recurrence, progression to muscle invasion, survival, and toxic effects', 'muscle invasion', 'cancer recurrence', 'risk of recurrence']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0750491', 'cui_str': 'Suspected (qualifier value)'}, {'cui': 'C1962916', 'cui_str': 'Low grade (lymphoma)'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0700364', 'cui_str': 'Appearances (qualifier value)'}, {'cui': 'C1962917', 'cui_str': 'High grade (lymphoma)'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0401496', 'cui_str': 'Transurethral resection of bladder neoplasm'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0010702', 'cui_str': 'Cystoscopy'}, {'cui': 'C0010820', 'cui_str': 'cytology'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C4709308', 'cui_str': '215 (qualifier value)'}]","[{'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0021917', 'cui_str': 'Instillation, Bladder'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",215.0,0.269559,"There were no grade 4 or 5 adverse events and no significant differences in adverse events of grade 3 or lower. ","[{'ForeName': 'Edward M', 'Initials': 'EM', 'LastName': 'Messing', 'Affiliation': 'University of Rochester, Rochester, New York.'}, {'ForeName': 'Catherine M', 'Initials': 'CM', 'LastName': 'Tangen', 'Affiliation': 'SWOG Statistical Center, Seattle, Washington.'}, {'ForeName': 'Seth P', 'Initials': 'SP', 'LastName': 'Lerner', 'Affiliation': 'Baylor College of Medicine, Houston, Texas.'}, {'ForeName': 'Deepak M', 'Initials': 'DM', 'LastName': 'Sahasrabudhe', 'Affiliation': 'University of Rochester, Rochester, New York.'}, {'ForeName': 'Theresa M', 'Initials': 'TM', 'LastName': 'Koppie', 'Affiliation': 'Oregon Health & Science University, Portland.'}, {'ForeName': 'David P', 'Initials': 'DP', 'LastName': 'Wood', 'Affiliation': 'Beaumont Health, Royal Oak, Michigan.'}, {'ForeName': 'Philip C', 'Initials': 'PC', 'LastName': 'Mack', 'Affiliation': 'University of California Davis, Sacramento.'}, {'ForeName': 'Robert S', 'Initials': 'RS', 'LastName': 'Svatek', 'Affiliation': 'University of Texas-San Antonio, San Antonio.'}, {'ForeName': 'Christopher P', 'Initials': 'CP', 'LastName': 'Evans', 'Affiliation': 'University of California Davis, Sacramento.'}, {'ForeName': 'Khaled S', 'Initials': 'KS', 'LastName': 'Hafez', 'Affiliation': 'University of Michigan, Ann Arbor.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Culkin', 'Affiliation': 'University of Oklahoma, Oklahoma City.'}, {'ForeName': 'Timothy C', 'Initials': 'TC', 'LastName': 'Brand', 'Affiliation': 'Madigan Army Medical Center, Tacoma, Washington.'}, {'ForeName': 'Lawrence I', 'Initials': 'LI', 'LastName': 'Karsh', 'Affiliation': 'Urology Center of Colorado, Denver.'}, {'ForeName': 'Jeffrey M', 'Initials': 'JM', 'LastName': 'Holzbeierlein', 'Affiliation': 'University of Kansas Cancer Center, Kansas City.'}, {'ForeName': 'Shandra S', 'Initials': 'SS', 'LastName': 'Wilson', 'Affiliation': 'University of Colorado, Aurora.'}, {'ForeName': 'Guan', 'Initials': 'G', 'LastName': 'Wu', 'Affiliation': 'University of Rochester, Rochester, New York.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Plets', 'Affiliation': 'SWOG Statistical Center, Seattle, Washington.'}, {'ForeName': 'Nicholas J', 'Initials': 'NJ', 'LastName': 'Vogelzang', 'Affiliation': 'Comprehensive Cancer Centers of Nevada, Las Vegas.'}, {'ForeName': 'Ian M', 'Initials': 'IM', 'LastName': 'Thompson', 'Affiliation': 'CHRISTUS Santa Rosa Medical Center, San Antonio, Texas.'}]",JAMA,['10.1001/jama.2018.4657'] 380,31032543,Effects of psychosensory stimulation on anal pressures: Effects of alfuzosin.,"BACKGROUND Our aim is to explain the lack of clarity in the ways in which anxiety and depression, which are common in defecatory disorders (DD), may contribute to the disorder. In this study, we evaluate the effects of mental stress and relaxation on anal pressures and the mechanisms thereof. METHODS In 38 healthy women and 36 DD patients, rectoanal pressures were assessed at rest and during mental stressors (ie, word-color conflict [Stroop] and mental arithmetic tests) and mental relaxation, before and after randomization to placebo or the adrenergic α 1 -antagonist alfuzosin. KEY RESULTS During the baseline Stroop test, the anal pressure increased by 6 ± 13 mm Hg (mean ± SD, P = 0.004) in healthy women and 9 ± 10 mm Hg (P = 0.0001) in constipated women. During mental arithmetic, the anal pressure increased in healthy (4 ± 8 mm Hg, P = 0.002) and constipated women (5 ± 9 mm Hg, P = 0.004). After relaxation, anal pressure declined (P = 0.0004) by 3 ± 4 mm Hg in DD patients but not in controls. Alfuzosin reduced (P = 0.0001) anal resting pressure (by 31 ± 19 mm Hg) vs placebo (16 ± 18 mm Hg). However, during the postdrug Stroop test, anal pressure increased (P = 0.0001) in participants who received alfuzosin but not placebo. CONCLUSIONS & INFERENCES In healthy controls and DD patients, mental stressors likely increased anal pressure by contracting the internal anal sphincter; relaxation reduced anal pressure in DD patients. Alfuzosin reduced anal resting pressure but did not block the Stroop-mediated contractile response, which suggests that this response is not entirely mediated by adrenergic α 1 receptors.",2019,"During mental arithmetic, the anal pressure increased in healthy (4 ± 8 mm Hg, P = 0.002) and constipated women (5 ± 9 mm Hg, P = 0.004).","['38 healthy women and 36 DD patients', 'healthy women and 9\xa0±']","['placebo', 'alfuzosin', 'psychosensory stimulation', 'Alfuzosin', 'placebo or the adrenergic α 1 -antagonist alfuzosin']","['anal pressure', 'rectoanal pressures', 'anal resting pressure', 'anal pressures']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0051150', 'cui_str': 'alfuzosin'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0001637', 'cui_str': 'Adrenergic Drugs'}, {'cui': 'C0243076', 'cui_str': 'antagonists'}]","[{'cui': 'C2939124', 'cui_str': 'Anal (qualifier value)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}]",38.0,0.303136,"During mental arithmetic, the anal pressure increased in healthy (4 ± 8 mm Hg, P = 0.002) and constipated women (5 ± 9 mm Hg, P = 0.004).","[{'ForeName': 'Anjani', 'Initials': 'A', 'LastName': 'Muthyala', 'Affiliation': 'Clinical Enteric Neuroscience Translational and Epidemiological Research Program, Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Kelly J', 'Initials': 'KJ', 'LastName': 'Feuerhak', 'Affiliation': 'Clinical Enteric Neuroscience Translational and Epidemiological Research Program, Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'William S', 'Initials': 'WS', 'LastName': 'Harmsen', 'Affiliation': 'Division of Biomedical Statistics and Informatics, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Subhankar', 'Initials': 'S', 'LastName': 'Chakraborty', 'Affiliation': 'Clinical Enteric Neuroscience Translational and Epidemiological Research Program, Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Kent R', 'Initials': 'KR', 'LastName': 'Bailey', 'Affiliation': 'Division of Biomedical Statistics and Informatics, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Adil E', 'Initials': 'AE', 'LastName': 'Bharucha', 'Affiliation': 'Clinical Enteric Neuroscience Translational and Epidemiological Research Program, Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota.'}]",Neurogastroenterology and motility : the official journal of the European Gastrointestinal Motility Society,['10.1111/nmo.13618'] 381,32255919,The effect of combined corticotomy and low level laser therapy on the rate of orthodontic tooth movement: split mouth randomized clinical trial.,"Purpose The aim of this study was to evaluate the combined effect of corticotomy and Low-Level Laser Therapy(LLLT) on the rate of orthodontic tooth movement. Methods A randomized split-mouth design for 16 female patients compared the rate of maxillary canine retraction using corticotomy combined with LLLT versus corticotomy only. The device used in the present study was an In-Ga-As semiconductor diode laser emitting at 940 nm (IR) with these parameters: 0.5 W/ cm 2 power density, 5 J/cm 2 Fluence, CW, 240 sec time irradiation, weekly for the first month and twice monthly for the next three months. Assessment of the rate of canine retraction was carried out via a series of dental models. Results A non-significant statistical rate of canine retraction was achieved by LLLT combined to corticotomy compared with the corticotomy technique alone. Conclusion Low-Level Laser Therapy combined to corticotomy could not achieve a higher rate of canine retraction compared to the golden standard corticotomy technique alone. No long-term adverse effects on the alveolar mucosa were detected following both techniques.",2019,"A non-significant statistical rate of canine retraction was achieved by LLLT combined to corticotomy compared with the corticotomy technique alone. ",['16 female patients'],"['corticotomy and Low-Level Laser Therapy(LLLT', 'combined corticotomy and low level laser therapy', 'LLLT']","['canine retraction', 'alveolar mucosa', 'rate of maxillary canine retraction', 'rate of canine retraction']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0279027', 'cui_str': 'Low power laser therapy'}]","[{'cui': 'C0010482', 'cui_str': 'Structure of canine tooth'}, {'cui': 'C0332523', 'cui_str': 'Retraction'}, {'cui': 'C0026724', 'cui_str': 'Mucosal'}, {'cui': 'C0024947', 'cui_str': 'Bone structure of maxilla'}]",16.0,0.0896618,"A non-significant statistical rate of canine retraction was achieved by LLLT combined to corticotomy compared with the corticotomy technique alone. ","[{'ForeName': 'Karim A', 'Initials': 'KA', 'LastName': 'Farid', 'Affiliation': 'PhD researcher, Orthodontic department, Faculty of Dentistry, Cairo University, Assistant Lecturer in MSA University, Egypt.'}, {'ForeName': 'Ahmed A', 'Initials': 'AA', 'LastName': 'Eid', 'Affiliation': 'Professor, Orthodontic department, Faculty of Dentistry, Cairo University, Egypt.'}, {'ForeName': 'Mohammed A', 'Initials': 'MA', 'LastName': 'Kaddah', 'Affiliation': 'Professor, Orthodontic department, Faculty of Dentistry, Cairo University, Egypt.'}, {'ForeName': 'Foad A', 'Initials': 'FA', 'LastName': 'Elsharaby', 'Affiliation': 'Assistant Professor, Orthodontic department, Faculty of Dentistry, Cairo University, Egypt.'}]",Laser therapy,['10.5978/islsm.19-OR-19'] 382,31679677,"Acute Achilles Tendon Ruptures: Efficacy of Conservative and Surgical (Percutaneous, Open) Treatment-A Randomized, Controlled, Clinical Trial.","There is controversy regarding the best treatment for acute ruptures of the Achilles tendon. Multiple treatments present good results in the short and long term, none being superior to the other if a protocol of rehabilitation with full early weightbearing rehabilitation is followed. The objective of this study was to provide evidence on the efficacy and safety of conservative or surgical (percutaneous or open) treatment for acute Achilles tendon rupture. A randomized, controlled, parallel-groups, pilot clinical trial was performed in patients aged ≥18 years who arrived at the emergency room of our center experiencing acute Achilles tendon rupture. Patients were randomized via a computer-generated list to receive 1 of 3 treatments (conservative, percutaneous surgery, or open surgery). All patients followed the same protocol of rehabilitation with early weightbearing. A responder (i.e., successful treatment) was defined as capable of standing heelrise mono- and bipodally for 3 seconds, having a pain score ≤2 (verbal numerical rating scale) after walking, and having returned to active previous life (sport) at 1-year follow-up. From 2014 to 2017, 34 consecutive patients (median age, 41 years [range 18 to 59]; 32 male [94%]) were included: 11 conservative treatment, 11 percutaneous surgery, and 12 open surgery. At 1-year follow-up, the proportion of responders was 100% (11/11, 95% confidence interval [CI] 74% to 100%), 82% (9/11, 95% CI 52% to 95%), and 83% (10/12, 95% CI 55% to 95%), respectively. There was no case of total rerupture. Similar efficacy was found for conservative, percutaneous, and open surgery treatments for acute Achilles tendon rupture at 1-year follow-up with an early weightbearing rehabilitation program.",2019,"Similar efficacy was found for conservative, percutaneous, and open surgery treatments for acute Achilles tendon rupture at 1-year follow-up with an early weightbearing rehabilitation program.","['patients aged ≥18 years who arrived at the emergency room of our center experiencing acute Achilles tendon rupture', 'acute Achilles tendon rupture', 'Acute Achilles Tendon Ruptures', 'From 2014 to 2017, 34 consecutive patients (median age, 41 years [range 18 to 59]; 32 male [94%]) were included: 11 conservative treatment, 11 percutaneous surgery, and 12 open surgery']","['computer-generated list to receive 1 of 3 treatments (conservative, percutaneous surgery, or open surgery', 'conservative or surgical (percutaneous or open) treatment', 'Conservative and Surgical (Percutaneous, Open']","['efficacy and safety', 'total rerupture', 'pain score ≤2 (verbal numerical rating scale']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0263970', 'cui_str': 'Rupture of Achilles tendon'}, {'cui': 'C0151937', 'cui_str': 'Traumatic rupture of tendon'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0459914', 'cui_str': 'Conservative Management'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach - access (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0348025', 'cui_str': 'Open approach - access (qualifier value)'}]","[{'cui': 'C0009622', 'cui_str': 'Computers'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach - access (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0348025', 'cui_str': 'Open approach - access (qualifier value)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0439824', 'cui_str': 'Verbal (qualifier value)'}, {'cui': 'C0222045'}]",34.0,0.106292,"Similar efficacy was found for conservative, percutaneous, and open surgery treatments for acute Achilles tendon rupture at 1-year follow-up with an early weightbearing rehabilitation program.","[{'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Manent', 'Affiliation': 'Surgeon, Orthopaedic and Trauma Surgery Department, Hospital Consorci Sanitari Integral, Sant Joan Despí, Barcelona, Catalonia, Spain. Electronic address: amanentm@gmail.com.'}, {'ForeName': 'Laia', 'Initials': 'L', 'LastName': 'López', 'Affiliation': 'Surgeon, Orthopaedic and Trauma Surgery Department, Hospital Consorci Sanitari Integral, Sant Joan Despí, Barcelona, Catalonia, Spain.'}, {'ForeName': 'Héctor', 'Initials': 'H', 'LastName': 'Coromina', 'Affiliation': 'Medical Doctor, Rheumatology Department, Hospital de la Santa Creu i Sant Pau, Barcelona, Catalonia, Spain.'}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Santamaría', 'Affiliation': 'Surgeon, Orthopaedic and Trauma Surgery Department, Hospital Consorci Sanitari Integral, Sant Joan Despí, Barcelona, Catalonia, Spain.'}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Domínguez', 'Affiliation': 'Surgeon, Orthopaedic and Trauma Surgery Department, Hospital Consorci Sanitari Integral, Sant Joan Despí, Barcelona, Catalonia, Spain.'}, {'ForeName': 'Natalia', 'Initials': 'N', 'LastName': 'Llorens', 'Affiliation': 'Surgeon, Orthopaedic and Trauma Surgery Department, Hospital Consorci Sanitari Integral, Sant Joan Despí, Barcelona, Catalonia, Spain.'}, {'ForeName': 'Miquel', 'Initials': 'M', 'LastName': 'Sales', 'Affiliation': 'Surgeon, Orthopaedic and Trauma Surgery Department, Hospital Consorci Sanitari Integral, Sant Joan Despí, Barcelona, Catalonia, Spain.'}, {'ForeName': 'Sebastián', 'Initials': 'S', 'LastName': 'Videla', 'Affiliation': ""Associate, Clinical Research Support Unit, Clinical Pharmacology Department, Bellvitge University Hospital/Bellvitge Biomedical Research Institute/University of Barcelona, L'Hospitalet del Llobregat, Barcelona, Catalonia, Spain.""}]",The Journal of foot and ankle surgery : official publication of the American College of Foot and Ankle Surgeons,['10.1053/j.jfas.2019.02.002'] 383,31910992,Long-Term Neurobehavioral and Quality of Life Outcomes of Critically Ill Children after Glycemic Control.,"OBJECTIVES To investigate adaptive skills, behavior, and quality health-related quality of life in children from 32 centers enrolling in the Heart And Lung Failure-Pediatric INsulin Titration randomized controlled trial. STUDY DESIGN This prospective longitudinal cohort study compared the effect of 2 tight glycemic control ranges (lower target, 80-100 mg/dL vs higher target, 150-180 mg/dL) 1-year neurobehavioral and health-related quality of life outcomes. Subjects had confirmed hyperglycemia and cardiac and/or respiratory failure. Patients aged 2-16 years old enrolled between April 2012 and September 2016 were studied at 1 year after intensive care discharge. The primary outcome, adaptive skills, was assessed using the Vineland Adaptive Behavior Scale. Behavior and health-related quality of life outcomes were assessed as secondary outcomes using the Pediatric Quality of Life and Child Behavior Checklist at baseline and 1-year follow-up. Group differences were evaluated using regression models adjusting for age category, baseline overall performance, and risk of mortality. RESULTS Of 369 eligible children, 358 survived after hospital discharge and 214 (60%) completed follow-up. One-year Vineland Adaptive Behavior Scale-II composite scores were not different (mean ± SD, 79.9 ± 25.5 vs 79.4 ± 26.9, lower vs higher target; P = .20). Improvement in Pediatric Quality of Life total health from baseline was greater in the higher target group (adjusted mean difference, 8.2; 95% CI, 1.1-15.3; P = .02). CONCLUSIONS One-year adaptive behavior in critically ill children with lower vs higher target glycemic control did not differ. The higher target group demonstrated improvement from baseline in overall health. This study affirms the lack of benefit of lower glucose targeting. TRIAL REGISTRATION ClinicalTrials.gov: NCT01565941.",2020,"One-year Vineland Adaptive Behavior Scale-II composite scores were not different (mean ± SD, 79.9 ± ","['Subjects had confirmed hyperglycemia and cardiac and/or respiratory failure', 'Patients aged 2-16\xa0years old enrolled between April 2012 and September 2016 were studied at 1\xa0year after intensive care discharge', '369 eligible children, 358 survived after hospital discharge and 214 (60%) completed follow-up', 'children from 32 centers enrolling in the Heart And Lung Failure-Pediatric INsulin Titration randomized controlled trial', 'Critically Ill Children after Glycemic Control']",[],"['neurobehavioral and health-related quality of life outcomes', 'Behavior and health-related quality of life outcomes', 'adaptive skills', 'Vineland Adaptive Behavior Scale', 'adaptive skills, behavior, and quality health-related quality of life', 'overall performance, and risk of mortality', 'Pediatric Quality of Life and Child Behavior Checklist', 'One-year Vineland Adaptive Behavior Scale-II composite scores', 'Pediatric Quality of Life total health', 'overall health']","[{'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C3889105', 'cui_str': 'Respiratory failure (SMQ)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0085559'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0018787', 'cui_str': 'Heart'}, {'cui': 'C0024109', 'cui_str': 'Lung'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C1096777', 'cui_str': 'Randomized Controlled Trial'}, {'cui': 'C0010340', 'cui_str': 'Critically Ill'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]",[],"[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0582680', 'cui_str': 'Vineland adaptive behavior scales (assessment scale)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0008065', 'cui_str': 'Child Behavior'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]",369.0,0.429229,"One-year Vineland Adaptive Behavior Scale-II composite scores were not different (mean ± SD, 79.9 ± ","[{'ForeName': 'Katherine V', 'Initials': 'KV', 'LastName': 'Biagas', 'Affiliation': ""Department of Pediatrics, Stony Brook Children's Hospital and the Renaissance School of Medicine, Stony Brook, NY. Electronic address: katherine.biagas@stonybrookmedicine.edu.""}, {'ForeName': 'Veronica J', 'Initials': 'VJ', 'LastName': 'Hinton', 'Affiliation': 'Department of Psychology, Queens College and the Graduate Center of the City University of New York, New York, NY.'}, {'ForeName': 'Natalie R', 'Initials': 'NR', 'LastName': 'Hasbani', 'Affiliation': ""Department of Cardiology, Boston Children's Hospital and Harvard Medical School, Boston, MA.""}, {'ForeName': 'Peter M', 'Initials': 'PM', 'LastName': 'Luckett', 'Affiliation': ""Department of Pediatrics, University of Texas Southwestern Medical Center and Children's Health, Dallas, TX.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Wypij', 'Affiliation': ""Department of Cardiology, Boston Children's Hospital and Harvard Medical School, Boston, MA.""}, {'ForeName': 'Vinay M', 'Initials': 'VM', 'LastName': 'Nadkarni', 'Affiliation': ""Department of Anesthesiology and Critical Care Medicine, Children's Hospital of Philadelphia and the University of Pennsylvania, Philadelphia, PA.""}, {'ForeName': 'Michael S D', 'Initials': 'MSD', 'LastName': 'Agus', 'Affiliation': ""Division of Medical Critical Care, Department of Pediatrics, Boston Children's Hospital and Harvard Medical School, Boston, MA.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Journal of pediatrics,['10.1016/j.jpeds.2019.10.055'] 384,31891601,Evaluation of a savings-led family-based economic empowerment intervention for AIDS-affected adolescents in Uganda: A four-year follow-up on efficacy and cost-effectiveness.,"BACKGROUND Children who have lost a parent to HIV/AIDS, known as AIDS orphans, face multiple stressors affecting their health and development. Family economic empowerment (FEE) interventions have the potential to improve these outcomes and mitigate the risks they face. We present efficacy and cost-effectiveness analyses of the Bridges study, a savings-led FEE intervention among AIDS-orphaned adolescents in Uganda at four-year follow-up. METHODS Intent-to-treat analyses using multilevel models compared the effects of two savings-led treatment arms: Bridges (1:1 matched incentive) and BridgesPLUS (2:1 matched incentive) to a usual care control group on the following outcomes: self-rated health, sexual health, and mental health functioning. Total per-participant costs for each arm were calculated using the treatment-on-the-treated sample. Intervention effects and per-participant costs were used to calculate incremental cost-effectiveness ratios (ICERs). FINDINGS Among 1,383 participants, 55% were female, 20% were double orphans. Mean age was 12 years at baseline. At 48-months, BridgesPLUS significantly improved self-rated health, (0.25, 95% CI 0.06, 0.43), HIV knowledge (0.21, 95% CI 0.01, 0.41), self-concept (0.26, 95% CI 0.09, 0.44), and self-efficacy (0.26, 95% CI 0.09, 0.43) and lowered hopelessness (-0.28, 95% CI -0.43, -0.12); whereas Bridges improved self-rated health (0.26, 95% CI 0.08, 0.43) and HIV knowledge (0.22, 95% CI 0.05, 0.39). ICERs ranged from $224 for hopelessness to $298 for HIV knowledge per 0.2 standard deviation change. CONCLUSIONS Most intervention effects were sustained in both treatment arms at two years post-intervention. Higher matching incentives yielded a significant and lasting effect on a greater number of outcomes among adolescents compared to lower matching incentives at a similar incremental cost per unit effect. These findings contribute to the evidence supporting the incorporation of FEE interventions within national social protection frameworks.",2019,Higher matching incentives yielded a significant and lasting effect on a greater number of outcomes among adolescents compared to lower matching incentives at a similar incremental cost per unit effect.,"['AIDS-affected adolescents in Uganda', 'AIDS-orphaned adolescents in Uganda at four-year follow-up', 'Mean age was 12 years at baseline', 'Children who have lost a parent to HIV/AIDS, known as AIDS orphans', '1,383 participants, 55% were female, 20% were double orphans']","['savings-led FEE intervention', 'two savings-led treatment arms: Bridges (1:1 matched incentive) and BridgesPLUS (2:1 matched incentive) to a usual care control group on the following outcomes: self-rated health, sexual health, and mental health functioning', 'savings-led family-based economic empowerment intervention']","['Total per-participant costs', 'ICERs', 'lowered hopelessness', 'efficacy and cost-effectiveness', 'incremental cost-effectiveness ratios (ICERs', 'self-rated health', 'HIV knowledge', 'self-efficacy', 'Bridges improved self-rated health']","[{'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0041573', 'cui_str': 'Republic of Uganda'}, {'cui': 'C0242299', 'cui_str': 'Orphans'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0205309', 'cui_str': 'Known (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}]","[{'cui': 'C0036245', 'cui_str': 'Savings'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0015751', 'cui_str': 'Fees'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0456378', 'cui_str': 'Type of bridge (attribute)'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C2362326', 'cui_str': 'Sexual Health'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0013557', 'cui_str': 'economics'}, {'cui': 'C0679959', 'cui_str': 'Empowerment'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C0150041', 'cui_str': 'Feeling of hopelessness'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0456378', 'cui_str': 'Type of bridge (attribute)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}]",1383.0,0.147934,Higher matching incentives yielded a significant and lasting effect on a greater number of outcomes among adolescents compared to lower matching incentives at a similar incremental cost per unit effect.,"[{'ForeName': 'Yesim', 'Initials': 'Y', 'LastName': 'Tozan', 'Affiliation': 'College of Global Public Health, New York University, New York, New York, United States of America.'}, {'ForeName': 'Sicong', 'Initials': 'S', 'LastName': 'Sun', 'Affiliation': 'International Center for Child Health and Development, Brown School, Washington University in Saint Louis, Saint Louis, Missouri, United States of America.'}, {'ForeName': 'Ariadna', 'Initials': 'A', 'LastName': 'Capasso', 'Affiliation': 'College of Global Public Health, New York University, New York, New York, United States of America.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Shu-Huah Wang', 'Affiliation': 'Department of Social Work and Social Administration, The University of Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'Torsten B', 'Initials': 'TB', 'LastName': 'Neilands', 'Affiliation': 'Center for AIDS Prevention Studies, School of Medicine, University of California, San Francisco, San Francisco, California, United States of America.'}, {'ForeName': 'Ozge Sensoy', 'Initials': 'OS', 'LastName': 'Bahar', 'Affiliation': 'International Center for Child Health and Development, Brown School, Washington University in Saint Louis, Saint Louis, Missouri, United States of America.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Damulira', 'Affiliation': 'International Center for Child Health and Development, Brown School, Washington University in Saint Louis, Saint Louis, Missouri, United States of America.'}, {'ForeName': 'Fred M', 'Initials': 'FM', 'LastName': 'Ssewamala', 'Affiliation': 'International Center for Child Health and Development, Brown School, Washington University in Saint Louis, Saint Louis, Missouri, United States of America.'}]",PloS one,['10.1371/journal.pone.0226809'] 385,31600598,A two-part phase 1 study to establish and compare the safety and local tolerability of two nasal formulations of XF-73 for decolonisation of Staphylococcus aureus: A previously investigated 0.5mg/g viscosified gel formulation versus a modified formulation.,"OBJECTIVES Successful decolonisation of nasal Staphylococcus aureus (SA) carriage by mupirocin is limited by increasing drug resistance. This randomised, open-label, phase 1 study compared the safety and local tolerability of two nasal formulations of XF-73, a novel porphyrinic antibacterial with rapid intrinsic activity against SA. METHODS The study was performed in 60 healthy adults. In Part 1, eight non-SA carriers were randomised to groups of four subjects each and were treated with XF-73 concentrations of 0.5mg/g 2% gel or 2.0mg/g 2% gel. In Part 2, 52 persistent SA carriers were randomised to groups of 13 subjects each and were treated with XF-73 concentrations of 0.5mg/g 2% gel, 2.0mg/g 2% gel, 0.5mg/g 4% gel or 4% viscosified placebo gel. Plasma pharmacokinetic and pharmacodynamic studies were performed. Antistaphylococcal activity was assessed as the presence/absence of SA and by quantification of colonisation using a semiquantitative scale (SA score). RESULTS 56 subjects (8/8 from Part 1 and 48/52 from Part 2) completed the study, with 47/60 comprising the pharmacokinetic population and 48/60 the pharmacodynamic population. There was no measurable systemic absorption of XF-73. XF-73 treatment was associated with rapid reduction in SA score in all subjects. The most common treatment-emergent adverse events (TEAEs) were rhinorrhoea and nasal dryness (15.5% each in Parts 1 and 2). TEAEs were mild and resolved spontaneously. CONCLUSION XF-73 was well tolerated with minimal side effects at doses of 0.5mg/g 2% gel and 2.0mg/g 2% gel. These findings support further development of XF-73.",2020,"CONCLUSION XF-73 was found to be safe and was tolerated with minimal side effects at doses of 0.5 mg/g 2% gel and 2 mg/g 2% gel in healthy volunteers.","['2 dosing cohorts, and enrolled 60 healthy adults', '56 subjects (8/8 from Part 1 and 48/52 from Part 2) completed the study, with 47/60 comprising the PK population and 48/60 the PD population', '52 healthy persistent SA carriers', 'Staphylococcus aureus', 'healthy volunteers']","['XF-73 in concentrations of 0.5\u2009mg/g 2% gel and 2\u2009mg/g 2% gel, respectively', 'XF-73', 'XF-73 (0.5\u2009mg/g 2% gel, 2\u2009mg/g 2% gel and 0.5\u2009mg/g 4% gel) or a 4% viscosified placebo gel']","['systemic absorption of XF-73', 'safety and local tolerability', 'Anti-staphylococcal activity', 'rhinorrhea and nasal dryness', 'SA scores', 'Plasma pharmacokinetics (PK) and pharmacodynamics (PD) studies']","[{'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0560175', 'cui_str': 'Carrier State'}, {'cui': 'C0038172', 'cui_str': 'Staphylococcus aureus'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C1300563', 'cui_str': 'ug/mg'}, {'cui': 'C0017243', 'cui_str': 'Gel (basic dose form)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C3850076', 'cui_str': 'Systemic Absorption'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C1260880', 'cui_str': 'Nasal catarrh'}, {'cui': 'C0231919', 'cui_str': 'Nasal mucosa dry (finding)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]",60.0,0.0287411,"CONCLUSION XF-73 was found to be safe and was tolerated with minimal side effects at doses of 0.5 mg/g 2% gel and 2 mg/g 2% gel in healthy volunteers.","[{'ForeName': 'George A', 'Initials': 'GA', 'LastName': 'Yendewa', 'Affiliation': 'Department of Medicine and Division of Infectious Diseases and HIV Medicine, University Hospitals Cleveland Medical Center, Case Western Reserve University, Cleveland, OH, USA. Electronic address: gay7@case.edu.'}, {'ForeName': 'J McLeod', 'Initials': 'JM', 'LastName': 'Griffiss', 'Affiliation': 'ClinicalRM, Hinckley, OH, USA.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Jacobs', 'Affiliation': 'Department of Pathology, Case Western Reserve University, University Hospitals Cleveland Medical Center, Cleveland, OH, USA.'}, {'ForeName': 'Scott A', 'Initials': 'SA', 'LastName': 'Fulton', 'Affiliation': 'Department of Medicine and Division of Infectious Diseases and HIV Medicine, University Hospitals Cleveland Medical Center, Case Western Reserve University, Cleveland, OH, USA.'}, {'ForeName': 'Mary Ann', 'Initials': 'MA', 'LastName': ""O'Riordan"", 'Affiliation': 'Department of Pediatrics, Case Western Reserve University, Cleveland, OH, USA.'}, {'ForeName': 'Wesley A', 'Initials': 'WA', 'LastName': 'Gray', 'Affiliation': 'Department of Pediatrics, University of Toledo, Toledo, OH, USA.'}, {'ForeName': 'Howard M', 'Initials': 'HM', 'LastName': 'Proskin', 'Affiliation': 'Howard M. Proskin and Associates, Incorporated, Rochester, NY, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Winkle', 'Affiliation': 'Anaheim Clinical Trials, Anaheim, CA, USA.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Salata', 'Affiliation': 'Department of Medicine and Division of Infectious Diseases and HIV Medicine, University Hospitals Cleveland Medical Center, Case Western Reserve University, Cleveland, OH, USA.'}]",Journal of global antimicrobial resistance,['10.1016/j.jgar.2019.09.017'] 386,31109198,Cannabidiol for the Reduction of Cue-Induced Craving and Anxiety in Drug-Abstinent Individuals With Heroin Use Disorder: A Double-Blind Randomized Placebo-Controlled Trial.,"OBJECTIVE Despite the staggering consequences of the opioid epidemic, limited nonopioid medication options have been developed to treat this medical and public health crisis. This study investigated the potential of cannabidiol (CBD), a nonintoxicating phytocannabinoid, to reduce cue-induced craving and anxiety, two critical features of addiction that often contribute to relapse and continued drug use, in drug-abstinent individuals with heroin use disorder. METHODS This exploratory double-blind randomized placebo-controlled trial assessed the acute (1 hour, 2 hours, and 24 hours), short-term (3 consecutive days), and protracted (7 days after the last of three consecutive daily administrations) effects of CBD administration (400 or 800 mg, once daily for 3 consecutive days) on drug cue-induced craving and anxiety in drug-abstinent individuals with heroin use disorder. Secondary measures assessed participants' positive and negative affect, cognition, and physiological status. RESULTS Acute CBD administration, in contrast to placebo, significantly reduced both craving and anxiety induced by the presentation of salient drug cues compared with neutral cues. CBD also showed significant protracted effects on these measures 7 days after the final short-term (3-day) CBD exposure. In addition, CBD reduced the drug cue-induced physiological measures of heart rate and salivary cortisol levels. There were no significant effects on cognition, and there were no serious adverse effects. CONCLUSIONS CBD's potential to reduce cue-induced craving and anxiety provides a strong basis for further investigation of this phytocannabinoid as a treatment option for opioid use disorder.",2019,"There were no significant effects on cognition, and there were no serious adverse effects. ","['in drug-abstinent individuals with heroin use disorder', 'abstinent individuals with heroin use disorder', 'Drug-Abstinent Individuals With Heroin Use Disorder']","['Placebo', 'CBD administration (400 or 800 mg, once daily for 3 consecutive days) on drug cue-induced craving and anxiety', 'placebo', 'cannabidiol (CBD']","['serious adverse effects', 'CBD reduced the drug cue-induced physiological measures of heart rate and salivary cortisol levels', 'craving and anxiety', ""participants' positive and negative affect, cognition, and physiological status""]","[{'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0457801', 'cui_str': 'Current non-drinker of alcohol (finding)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0011892', 'cui_str': 'diamorphine'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C3844106', 'cui_str': 'Eight hundred'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0006863', 'cui_str': '1,3-Benzenediol, 2-(3-methyl-6-(1-methylethenyl)-2-cyclohexen-1-yl)-5-pentyl-, (1R-trans)-'}]","[{'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0205463', 'cui_str': 'Physiologic (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0442040', 'cui_str': 'Salivary (qualifier value)'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}]",,0.409529,"There were no significant effects on cognition, and there were no serious adverse effects. ","[{'ForeName': 'Yasmin L', 'Initials': 'YL', 'LastName': 'Hurd', 'Affiliation': 'Department of Psychiatry and Department of Neuroscience (Hurd, Spriggs, Oprescu) and Department of Population and Health Sciences (Winkel), Icahn School of Medicine at Mount Sinai, New York; Addiction Institute at Mount Sinai, New York (Hurd, Spriggs, Oprescu, Salsitz); Mount Sinai Beth Israel Hospital, New York (Alishayev, Gurgov, Kudrich, Salsitz).'}, {'ForeName': 'Sharron', 'Initials': 'S', 'LastName': 'Spriggs', 'Affiliation': 'Department of Psychiatry and Department of Neuroscience (Hurd, Spriggs, Oprescu) and Department of Population and Health Sciences (Winkel), Icahn School of Medicine at Mount Sinai, New York; Addiction Institute at Mount Sinai, New York (Hurd, Spriggs, Oprescu, Salsitz); Mount Sinai Beth Israel Hospital, New York (Alishayev, Gurgov, Kudrich, Salsitz).'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Alishayev', 'Affiliation': 'Department of Psychiatry and Department of Neuroscience (Hurd, Spriggs, Oprescu) and Department of Population and Health Sciences (Winkel), Icahn School of Medicine at Mount Sinai, New York; Addiction Institute at Mount Sinai, New York (Hurd, Spriggs, Oprescu, Salsitz); Mount Sinai Beth Israel Hospital, New York (Alishayev, Gurgov, Kudrich, Salsitz).'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Winkel', 'Affiliation': 'Department of Psychiatry and Department of Neuroscience (Hurd, Spriggs, Oprescu) and Department of Population and Health Sciences (Winkel), Icahn School of Medicine at Mount Sinai, New York; Addiction Institute at Mount Sinai, New York (Hurd, Spriggs, Oprescu, Salsitz); Mount Sinai Beth Israel Hospital, New York (Alishayev, Gurgov, Kudrich, Salsitz).'}, {'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Gurgov', 'Affiliation': 'Department of Psychiatry and Department of Neuroscience (Hurd, Spriggs, Oprescu) and Department of Population and Health Sciences (Winkel), Icahn School of Medicine at Mount Sinai, New York; Addiction Institute at Mount Sinai, New York (Hurd, Spriggs, Oprescu, Salsitz); Mount Sinai Beth Israel Hospital, New York (Alishayev, Gurgov, Kudrich, Salsitz).'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Kudrich', 'Affiliation': 'Department of Psychiatry and Department of Neuroscience (Hurd, Spriggs, Oprescu) and Department of Population and Health Sciences (Winkel), Icahn School of Medicine at Mount Sinai, New York; Addiction Institute at Mount Sinai, New York (Hurd, Spriggs, Oprescu, Salsitz); Mount Sinai Beth Israel Hospital, New York (Alishayev, Gurgov, Kudrich, Salsitz).'}, {'ForeName': 'Anna M', 'Initials': 'AM', 'LastName': 'Oprescu', 'Affiliation': 'Department of Psychiatry and Department of Neuroscience (Hurd, Spriggs, Oprescu) and Department of Population and Health Sciences (Winkel), Icahn School of Medicine at Mount Sinai, New York; Addiction Institute at Mount Sinai, New York (Hurd, Spriggs, Oprescu, Salsitz); Mount Sinai Beth Israel Hospital, New York (Alishayev, Gurgov, Kudrich, Salsitz).'}, {'ForeName': 'Edwin', 'Initials': 'E', 'LastName': 'Salsitz', 'Affiliation': 'Department of Psychiatry and Department of Neuroscience (Hurd, Spriggs, Oprescu) and Department of Population and Health Sciences (Winkel), Icahn School of Medicine at Mount Sinai, New York; Addiction Institute at Mount Sinai, New York (Hurd, Spriggs, Oprescu, Salsitz); Mount Sinai Beth Israel Hospital, New York (Alishayev, Gurgov, Kudrich, Salsitz).'}]",The American journal of psychiatry,['10.1176/appi.ajp.2019.18101191'] 387,31026780,"Effect of a 10-day transcutaneous trigeminal nerve stimulation (TNS) protocol for depression amelioration: A randomized, double blind, and sham-controlled phase II clinical trial.","BACKGROUND Major depressive disorder (MDD) is one of the leading causes of disability in the world. However, treatment options are still limited, and marked by high refractoriness rates, new approaches are needed to optimize clinical improvement. Trigeminal nerve stimulation (TNS) is an innovative neuromodulation strategy consisting on the application of an electric current over the trigeminal nerve that propagates stimuli towards brain areas involved in mood control. OBJECTIVE We examined the effects of TNS in MDD after a 10-day experimental protocol. METHODS This was a randomized, double blind, and sham-controlled phase II study with 24 patients with severe MDD. Patients underwent a 10-day intervention protocol and were assessed with the 17-item Hamilton Depression Rating Scale (HDRS-17) at following three observation points: baseline (T1), after 10 days (T2), and after one month of the last stimulation session (T3). Main clinical outcome analysis of variance (ANOVA) was performed. RESULTS Patients in the active group presented a mean reduction of 36.15% in depressive symptoms after the stimulation protocol. There was a significant interaction between group and time regarding HDRS-17 scores (F = 3.18; df = 2; p = 0.0456). Post hoc analyses exhibited a statistically significant difference between active and sham group symptoms at T2 (p = 0.040) and T3 (p = 0.026), which highlights the sustained amelioration of depressive symptoms. CONCLUSION The present study found amelioration of depressive symptoms for patients undergoing a 10-day stimulation protocol of TNS, and this was sustained after one month of follow-up.",2019,"Post hoc analyses exhibited a statistically significant difference between active and sham group symptoms at T2 (p = 0.040) and T3 (p = 0.026), which highlights the sustained amelioration of depressive symptoms. ","['patients undergoing a 10-day stimulation protocol of TNS, and this was sustained after one month of follow-up', '24 patients with severe MDD', 'Major depressive disorder (MDD', 'depression amelioration']","['10-day transcutaneous trigeminal nerve stimulation (TNS) protocol', 'Trigeminal nerve stimulation (TNS', 'TNS']","['time regarding HDRS-17 scores', 'depressive symptoms', '17-item Hamilton Depression Rating Scale (HDRS-17']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0052080', 'cui_str': '3-((phenylacetyl)amino)-2,6-piperidinedione'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0045733', 'cui_str': 'mansic acid'}, {'cui': 'C0443318', 'cui_str': 'Sustained (qualifier value)'}, {'cui': 'C4082115', 'cui_str': 'One month (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}]","[{'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0040996', 'cui_str': 'Cranial Nerve V'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0045733', 'cui_str': 'mansic acid'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0222045'}]",24.0,0.487494,"Post hoc analyses exhibited a statistically significant difference between active and sham group symptoms at T2 (p = 0.040) and T3 (p = 0.026), which highlights the sustained amelioration of depressive symptoms. ","[{'ForeName': 'Marcelo B', 'Initials': 'MB', 'LastName': 'Generoso', 'Affiliation': 'Department of Psychiatry and Medical Psychology, Faculty of Medical Sciences of Santa Casa de São Paulo, São Paulo, Brazil. Electronic address: marcelobrunogeneroso@gmail.com.'}, {'ForeName': 'Ivan T', 'Initials': 'IT', 'LastName': 'Taiar', 'Affiliation': 'Department of Psychiatry and Medical Psychology, Faculty of Medical Sciences of Santa Casa de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Lucas P', 'Initials': 'LP', 'LastName': 'Garrocini', 'Affiliation': 'Department of Psychiatry and Medical Psychology, Faculty of Medical Sciences of Santa Casa de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Bernardon', 'Affiliation': 'Department of Psychiatry and Medical Psychology, Faculty of Medical Sciences of Santa Casa de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Quirino', 'Initials': 'Q', 'LastName': 'Cordeiro', 'Affiliation': 'Department of Psychiatry and Medical Psychology, Faculty of Medical Sciences of Santa Casa de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Ricardo R', 'Initials': 'RR', 'LastName': 'Uchida', 'Affiliation': 'Department of Psychiatry and Medical Psychology, Faculty of Medical Sciences of Santa Casa de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Shiozawa', 'Affiliation': 'Department of Psychiatry and Medical Psychology, Faculty of Medical Sciences of Santa Casa de São Paulo, São Paulo, Brazil. Electronic address: pedroshiozawa@gmail.com.'}]",Epilepsy & behavior : E&B,['10.1016/j.yebeh.2019.03.025'] 388,31010876,Prevalence and Prognosis of Unrecognized Myocardial Infarction in Asymptomatic Patients With Diabetes: A Two-Center Study With Up to 5 Years of Follow-up.,"OBJECTIVE To determine the prevalence and prognostic significance of unrecognized myocardial infarction (MI) by delayed-enhancement MRI (DE-MRI) in asymptomatic patients with diabetes. RESEARCH DESIGN AND METHODS In this prospective, two-center study of asymptomatic patients without known cardiac disease ( n = 120), two prespecified cohorts underwent a research MRI: 1 ) a high-risk group with type 1 diabetes and chronic renal insufficiency ( n = 50) and 2 ) an average-risk group with type 2 diabetes ( n = 70). The primary end point was a composite of all-cause mortality and clinical MI. RESULTS Overall, the prevalence of unrecognized MI was 19% by DE-MRI (28% high-risk group and 13% average-risk group) and 5% by electrocardiography. During up to 5 years of follow-up with a total of 460 patient-years of follow-up, the rate of death/MI was markedly higher in patients with diabetes with (vs. without) unrecognized MI (all 44% vs. 7%, high-risk group 43% vs. 6%, and average-risk group 44% vs. 8%; all P < 0.01). After adjustment for Framingham risk score, left ventricular ejection fraction, and diabetes type, the presence of unrecognized MI by DE-MRI conferred an eightfold increase in risk of death/MI (95% CI 3.0-21.1, P < 0.0001). Addition of unrecognized MI to clinical indices significantly improved model discrimination for adverse events (integrated discrimination improvement = 0.156, P = 0.001). CONCLUSIONS Unrecognized MI is prevalent in asymptomatic patients with diabetes without a history of cardiac disease and confers a markedly increased risk of death and clinical MI.",2019,"Addition of unrecognized MI to clinical indices significantly improved model discrimination for adverse events (integrated discrimination improvement = 0.156, P = 0.001). ","['asymptomatic patients without known cardiac disease ( n = 120), two prespecified cohorts underwent a research MRI: 1 ) a high-risk group with type 1 diabetes and chronic renal insufficiency ( n = 50) and 2 ) an average-risk group with type 2 diabetes ( n = 70', 'asymptomatic patients with diabetes', 'Asymptomatic Patients With Diabetes']",['delayed-enhancement MRI (DE-MRI'],"['rate of death/MI', 'prevalence of unrecognized MI', 'model discrimination for adverse events', 'risk of death/MI', 'risk of death and clinical MI', 'Framingham risk score, left ventricular ejection fraction, and diabetes type', 'composite of all-cause mortality and clinical MI']","[{'cui': 'C0231221', 'cui_str': 'Asymptomatic (finding)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205309', 'cui_str': 'Known (qualifier value)'}, {'cui': 'C0018799', 'cui_str': 'Cardiac Diseases'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0035168'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0403447', 'cui_str': 'Renal Insufficiency, Chronic'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}]","[{'cui': 'C1627358', 'cui_str': 'Refractive surgery enhancement'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C0012632', 'cui_str': 'Discrimination'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction (observable entity)'}, {'cui': 'C1320657', 'cui_str': 'Diabetes type'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}]",,0.0525878,"Addition of unrecognized MI to clinical indices significantly improved model discrimination for adverse events (integrated discrimination improvement = 0.156, P = 0.001). ","[{'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Elliott', 'Affiliation': 'Duke Cardiovascular Magnetic Resonance Center and Division of Cardiology, Duke University Medical Center, Durham, NC michael.elliott@atriumhealth.org.'}, {'ForeName': 'John F', 'Initials': 'JF', 'LastName': 'Heitner', 'Affiliation': 'Duke Cardiovascular Magnetic Resonance Center and Division of Cardiology, Duke University Medical Center, Durham, NC.'}, {'ForeName': 'Han', 'Initials': 'H', 'LastName': 'Kim', 'Affiliation': 'Duke Cardiovascular Magnetic Resonance Center and Division of Cardiology, Duke University Medical Center, Durham, NC.'}, {'ForeName': 'Edwin', 'Initials': 'E', 'LastName': 'Wu', 'Affiliation': 'Division of Cardiology, Northwestern University Feinberg School of Medicine, Chicago, IL.'}, {'ForeName': 'Michele A', 'Initials': 'MA', 'LastName': 'Parker', 'Affiliation': 'Duke Cardiovascular Magnetic Resonance Center and Division of Cardiology, Duke University Medical Center, Durham, NC.'}, {'ForeName': 'Daniel C', 'Initials': 'DC', 'LastName': 'Lee', 'Affiliation': 'Division of Cardiology, Northwestern University Feinberg School of Medicine, Chicago, IL.'}, {'ForeName': 'Dixon B', 'Initials': 'DB', 'LastName': 'Kaufman', 'Affiliation': 'Division of Organ Transplantation, Department of Surgery, Northwestern University Feinberg School of Medicine, Chicago, IL.'}, {'ForeName': 'Robert O', 'Initials': 'RO', 'LastName': 'Bonow', 'Affiliation': 'Division of Cardiology, Northwestern University Feinberg School of Medicine, Chicago, IL.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Judd', 'Affiliation': 'Duke Cardiovascular Magnetic Resonance Center and Division of Cardiology, Duke University Medical Center, Durham, NC.'}, {'ForeName': 'Raymond J', 'Initials': 'RJ', 'LastName': 'Kim', 'Affiliation': 'Duke Cardiovascular Magnetic Resonance Center and Division of Cardiology, Duke University Medical Center, Durham, NC.'}]",Diabetes care,['10.2337/dc18-2266'] 389,31078935,A pilot study of combined endurance and resistance exercise rehabilitation for verbal memory and functional connectivity improvement in epilepsy.,"Memory impairment is common in persons with epilepsy (PWE), and exercise may be a strategy for its improvement. In this pilot study, we hypothesized that exercise rehabilitation would improve physical fitness and verbal memory and induce changes in brain networks involved in memory processes. We examined the effects of combined endurance and resistance exercise rehabilitation on memory and resting state functional connectivity (rsFC). Participants were randomized to exercise (PWE-E) or control (PWE-noE). The exercise intervention consisted of 18 supervised sessions on nonconsecutive days over 6 weeks. Before and after the intervention period, both groups completed self-report assessments (Short Form-36 (SF-36), Baecke Questionnaire (BQ) of habitual physical activity, and Profile of Mood States (POMS)), cognitive testing (California Verbal Learning Test-II (CVLT-II)), and magnetic resonance imaging (MRI); PWE-E also completed exercise performance tests. After completing the study, PWE-noE were offered cross-over to the exercise arm. There were no differences in baseline demographic, clinical, or assessment variables between 8 PWE-noE and 9 PWE-E. Persons with epilepsy that participated in exercise intervention increased maximum voluntary strength (all strength tests p < 0.05) and exhibited nonsignificant improvement in cardiorespiratory fitness (p = 0.15). Groups did not show significant changes in quality of life (QOL) or habitual physical activity between visits. However, there was an effect of visit on POMS total mood disturbance (TMD) measure showing improvement from baseline to visit 2 (p = 0.023). There were significant group by visit interactions on CVLT-II learning score (p = 0.044) and total recognition discriminability (d') (p = 0.007). Persons with epilepsy that participated in exercise intervention had significant reductions in paracingulate rsFC with the anterior cingulate and increases in rsFC for the cerebellum, thalamus, posterior cingulate cortex (PCC), and left and right inferior parietal lobule (IPL) (corrected p < 0.05). Change in CVLT-II learning score was associated with rsFC changes for the paracingulate cortex (r S  = -0.67; p = 0.0033), left IPL (r S  = 0.70; p = 0.0019), and right IPL (r S  = 0.71; p = 0.0015) while change in d' was associated with change in cerebellum rsFC to angular/middle occipital gyrus (r S  = 0.68; p = 0.0025). Our conclusion is that exercise rehabilitation may facilitate verbal memory improvement and brain network functional connectivity changes in PWE and that improved memory performance is associated with changes in rsFC. A larger randomized controlled trial of exercise rehabilitation for cognitive improvement in PWE is warranted.",2019,"Persons with epilepsy that participated in exercise intervention had significant reductions in paracingulate rsFC with the anterior cingulate and increases in rsFC for the cerebellum, thalamus, posterior cingulate cortex (PCC), and left and right inferior parietal lobule (IPL) (corrected p < 0.05).","['persons with epilepsy (PWE', 'Persons with epilepsy', 'epilepsy']","['exercise (PWE-E) or control (PWE-noE', 'exercise rehabilitation', 'exercise intervention', 'combined endurance and resistance exercise rehabilitation']","['left IPL', 'visit interactions on CVLT-II learning score', 'paracingulate rsFC', 'Change in CVLT-II learning score', 'cardiorespiratory fitness', 'self-report assessments (Short Form-36 (SF-36), Baecke Questionnaire (BQ) of habitual physical activity, and Profile of Mood States (POMS)), cognitive testing (California Verbal Learning Test-II (CVLT-II)), and magnetic resonance imaging (MRI); PWE-E also completed exercise performance tests', 'physical fitness and verbal memory', 'right IPL', 'memory and resting state functional connectivity (rsFC', 'maximum voluntary strength', 'rsFC for the cerebellum, thalamus, posterior cingulate cortex (PCC), and left and right inferior parietal lobule (IPL', 'POMS total mood disturbance (TMD', 'total recognition discriminability', 'quality of life (QOL) or habitual physical activity']","[{'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0014544', 'cui_str': 'Seizure Disorder'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0518031', 'cui_str': 'Endurance capacity'}]","[{'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205353', 'cui_str': 'Habitual (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0451394', 'cui_str': 'Profile of mood states (assessment scale)'}, {'cui': 'C0589055', 'cui_str': 'TOMAL'}, {'cui': 'C1552358', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0561770', 'cui_str': 'Verbal memory observable'}, {'cui': 'C0205090', 'cui_str': 'Right (qualifier value)'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0439656', 'cui_str': 'Voluntary (qualifier value)'}, {'cui': 'C0007765', 'cui_str': 'Parencephalon'}, {'cui': 'C0039729', 'cui_str': 'Thalamencephalon'}, {'cui': 'C0175191', 'cui_str': 'Posterior Cingulate'}, {'cui': 'C0152304', 'cui_str': 'Inferior parietal lobule structure'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0524637', 'cui_str': 'Recognition (Psychology)'}, {'cui': 'C0034380'}]",,0.0393721,"Persons with epilepsy that participated in exercise intervention had significant reductions in paracingulate rsFC with the anterior cingulate and increases in rsFC for the cerebellum, thalamus, posterior cingulate cortex (PCC), and left and right inferior parietal lobule (IPL) (corrected p < 0.05).","[{'ForeName': 'Jane B', 'Initials': 'JB', 'LastName': 'Allendorfer', 'Affiliation': 'Department of Neurology, University of Alabama at Birmingham, Birmingham, AL, USA; UAB Center for Exercise Medicine, University of Alabama at Birmingham, Birmingham, AL, USA. Electronic address: jallendorfer@uabmc.edu.'}, {'ForeName': 'Gabrielle A', 'Initials': 'GA', 'LastName': 'Brokamp', 'Affiliation': 'Department of Neurology, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Rodolphe', 'Initials': 'R', 'LastName': 'Nenert', 'Affiliation': 'Department of Neurology, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Jerzy P', 'Initials': 'JP', 'LastName': 'Szaflarski', 'Affiliation': 'Department of Neurology, University of Alabama at Birmingham, Birmingham, AL, USA; Department of Neurobiology, University of Alabama at Birmingham, Birmingham, AL, USA; UAB Epilepsy Center, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Charity J', 'Initials': 'CJ', 'LastName': 'Morgan', 'Affiliation': 'Department of Biostatistics, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'S Craig', 'Initials': 'SC', 'LastName': 'Tuggle', 'Affiliation': 'Department of Cell, Developmental and Integrative Biology, University of Alabama at Birmingham, Birmingham, AL, USA; UAB Center for Exercise Medicine, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Ver Hoef', 'Affiliation': 'Department of Neurology, University of Alabama at Birmingham, Birmingham, AL, USA; UAB Epilepsy Center, University of Alabama at Birmingham, Birmingham, AL, USA; Birmingham VA Medical Center, Birmingham, AL, USA.'}, {'ForeName': 'Roy C', 'Initials': 'RC', 'LastName': 'Martin', 'Affiliation': 'Department of Neurology, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Basia A', 'Initials': 'BA', 'LastName': 'Szaflarski', 'Affiliation': 'Department of Neurology, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Manmeet', 'Initials': 'M', 'LastName': 'Kaur', 'Affiliation': 'Department of Neurology, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Adrienne C', 'Initials': 'AC', 'LastName': 'Lahti', 'Affiliation': 'Department of Psychiatry and Behavioral Neurobiology, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Marcas M', 'Initials': 'MM', 'LastName': 'Bamman', 'Affiliation': 'Department of Cell, Developmental and Integrative Biology, University of Alabama at Birmingham, Birmingham, AL, USA; UAB Center for Exercise Medicine, University of Alabama at Birmingham, Birmingham, AL, USA; Birmingham VA Medical Center, Birmingham, AL, USA.'}]",Epilepsy & behavior : E&B,['10.1016/j.yebeh.2019.04.020'] 390,32264800,Trajectories of Homeless Shelter Utilization in the At Home/Chez Soi Trial of Housing First.,"OBJECTIVE Studies have shown that Housing First, a recovery-oriented housing intervention, is effective in reducing service utilization among homeless individuals with mental illness, but less is known about how Housing First affects patterns of service use over time and about characteristics associated with various utilization trajectories. This analysis aimed to explore latent class trajectories of shelter utilization in a randomized controlled trial of Housing First conducted across five Canadian cities. METHODS Data from the At Home/Chez Soi trial were analyzed (N=2,058). Latent class growth analysis was performed using days of shelter utilization to identify trajectories over 24 months. Multinomial logistic regression was used to determine which baseline variables, including treatment group, could predict class membership. RESULTS Four shelter use trajectories were identified: consistently low (N=1,631, 79%); mostly low (N=120, 6%); early temporary increase (N=179, 9%); and higher use, late temporary increase (N=128, 6%). Treatment group was a significant predictor of class membership. Those enrolled in Housing First had lower odds of experiencing higher shelter use trajectories (mostly low: odds ratio [OR]=0.50, 95% confidence interval [CI]=0.34-0.72; early temporary increase: OR=0.21, 95% CI=0.15-0.31; higher use, late temporary increase: OR=0.14, 95% CI=0.09-0.22). Other variables associated with trajectory classes included older age and longer time homeless, both of which were associated with higher shelter use. CONCLUSIONS Several participant characteristics were associated with different shelter use patterns. Knowledge of variables associated with more favorable trajectories may help to inform service planning and contribute to modeling efforts for homelessness.",2020,"OBJECTIVE Studies have shown that Housing First, a recovery-oriented housing intervention, is effective in reducing service utilization among homeless individuals with mental illness, but less is known about how Housing First affects patterns of service use over time and about characteristics associated with various utilization trajectories.","['Homeless Shelter Utilization in the At Home/Chez Soi Trial of Housing First', 'homeless individuals with mental illness', 'Housing First conducted across five Canadian cities', 'Data from the At Home/Chez Soi trial were analyzed (N=2,058']",[],['class membership'],"[{'cui': 'C0237154', 'cui_str': 'Homeless'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0676803', 'cui_str': 'Styrene-oxide isomerase'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0020056', 'cui_str': 'Housed'}, {'cui': 'C0425242', 'cui_str': 'Homeless single person'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C0008848', 'cui_str': 'Cities'}]",[],"[{'cui': 'C0456387', 'cui_str': 'Class'}]",,0.0836163,"OBJECTIVE Studies have shown that Housing First, a recovery-oriented housing intervention, is effective in reducing service utilization among homeless individuals with mental illness, but less is known about how Housing First affects patterns of service use over time and about characteristics associated with various utilization trajectories.","[{'ForeName': 'Cherry M T', 'Initials': 'CMT', 'LastName': 'Chu', 'Affiliation': 'Department of Epidemiology, Biostatistics, and Occupational Health (Chu, Moodie), and Department of Psychiatry (Latimer), McGill University, Montreal; Douglas Mental Health University Institute, Montreal (Chu, Latimer); Department of Psychiatry and Behavioural Neurosciences, McMaster University, Hamilton, Canada (Streiner).'}, {'ForeName': 'Erica E M', 'Initials': 'EEM', 'LastName': 'Moodie', 'Affiliation': 'Department of Epidemiology, Biostatistics, and Occupational Health (Chu, Moodie), and Department of Psychiatry (Latimer), McGill University, Montreal; Douglas Mental Health University Institute, Montreal (Chu, Latimer); Department of Psychiatry and Behavioural Neurosciences, McMaster University, Hamilton, Canada (Streiner).'}, {'ForeName': 'David L', 'Initials': 'DL', 'LastName': 'Streiner', 'Affiliation': 'Department of Epidemiology, Biostatistics, and Occupational Health (Chu, Moodie), and Department of Psychiatry (Latimer), McGill University, Montreal; Douglas Mental Health University Institute, Montreal (Chu, Latimer); Department of Psychiatry and Behavioural Neurosciences, McMaster University, Hamilton, Canada (Streiner).'}, {'ForeName': 'Eric A', 'Initials': 'EA', 'LastName': 'Latimer', 'Affiliation': 'Department of Epidemiology, Biostatistics, and Occupational Health (Chu, Moodie), and Department of Psychiatry (Latimer), McGill University, Montreal; Douglas Mental Health University Institute, Montreal (Chu, Latimer); Department of Psychiatry and Behavioural Neurosciences, McMaster University, Hamilton, Canada (Streiner).'}]","Psychiatric services (Washington, D.C.)",['10.1176/appi.ps.201900260'] 391,32266572,Near Infrared (NIR) Fluorescence is Not a Substitute for Lymphoscintigraphy and Gamma Probe for Melanoma Sentinel Node Detection: Results from a Prospective Trial.,"BACKGROUND Sentinel lymph node (SLN) biopsy is the standard care for early detection and staging of lymph node metastasis in melanomas. Radiocolloids (RC) and blue dyes are used for SLN detection. Recently, near infrared (NIR) fluorescence tracing using indocyanine green has been developed as an alternative method for SLN detection. The relatively high tissue penetration depth of several millimeters and the ability to detect low concentrations of tracer both suggest that NIR may have significant advantages over RC and the blue dye methods. The objective of this study was to prospectively compare the performance of all three SLN detection techniques using them sequentially to evaluate the same group of patients. METHODS One hundred twenty-one primary cutaneous melanoma patients with an indication for SLN biopsy were assigned to the procedure following NIR, blue dye, and RC detection techniques. RESULTS No adverse event was reported. SLN was not detected in only 4.1% of cases. In 90.9%, an SLN was identified with NIR, but without any auxiliary technique in only 70.2% of cases. RC detected the SLN in 92.6% of cases. Patent blue was found in the sentinel node in 76.9%. The combination of all three techniques detected an SLN in 95.9% of cases. Metastases were present in 26.7%. The false-negative rate was 8.8%, with a negative predictive value of 91.2%. CONCLUSIONS RC was the only technique with high SLN detection. Both the blue dye and NIR methods added sensitivity to the detection rate but should not be a substitute for RC.",2020,No adverse event was reported.,"['One hundred twenty-one primary cutaneous melanoma patients with an indication for SLN biopsy', 'Melanoma Sentinel Node Detection']","['procedure following NIR, blue dye, and RC detection techniques']","['SLN', 'false-negative rate']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C3715213', 'cui_str': '21'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0025202', 'cui_str': 'Malignant melanoma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C1522495', 'cui_str': 'Sentinal Node'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0677944', 'cui_str': 'Sentinel node'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}]","[{'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C1260957', 'cui_str': 'Blue color'}, {'cui': 'C0013343', 'cui_str': 'Dye'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}]","[{'cui': 'C1522495', 'cui_str': 'Sentinal Node'}, {'cui': 'C0205558', 'cui_str': 'False negative'}]",121.0,0.0539327,No adverse event was reported.,"[{'ForeName': 'Carlos Eduardo Barbosa', 'Initials': 'CEB', 'LastName': 'de Carvalho', 'Affiliation': 'Department of Surgery, Melanoma and Sarcoma, Barretos Cancer Hospital, Barretos, SP, Brazil.'}, {'ForeName': 'Renato', 'Initials': 'R', 'LastName': 'Capuzzo', 'Affiliation': 'Department of Head and Neck, Barretos Cancer Hospital, Barretos, SP, Brazil.'}, {'ForeName': 'Camila', 'Initials': 'C', 'LastName': 'Crovador', 'Affiliation': 'Institute of Education and Research, Barretos Cancer Hospital, Barretos, SP, Brazil.'}, {'ForeName': 'Renan J', 'Initials': 'RJ', 'LastName': 'Teixeira', 'Affiliation': 'Institute of Education and Research, Barretos Cancer Hospital, Barretos, SP, Brazil.'}, {'ForeName': 'Ana Carolina', 'Initials': 'AC', 'LastName': 'Laus', 'Affiliation': 'Institute of Education and Research, Barretos Cancer Hospital, Barretos, SP, Brazil.'}, {'ForeName': 'Andre Lopes', 'Initials': 'AL', 'LastName': 'Carvalho', 'Affiliation': 'Institute of Education and Research, Barretos Cancer Hospital, Barretos, SP, Brazil.'}, {'ForeName': 'Vinicius L', 'Initials': 'VL', 'LastName': 'Vazquez', 'Affiliation': 'Department of Surgery, Melanoma and Sarcoma, Barretos Cancer Hospital, Barretos, SP, Brazil. viniciusvazquez@gmail.com.'}]",Annals of surgical oncology,['10.1245/s10434-020-08409-6'] 392,32265240,"Biomarker-guided implementation of the KDIGO guidelines to reduce the occurrence of acute kidney injury in patients after cardiac surgery (PrevAKI-multicentre): protocol for a multicentre, observational study followed by randomised controlled feasibility trial.","INTRODUCTION Acute kidney injury (AKI) is a frequent complication after cardiac surgery with adverse short-term and long-term outcomes. Although prevention of AKI (PrevAKI) is strongly recommended, the optimal strategy is uncertain. The Kidney Disease: Improving Global Outcomes (KDIGO) guideline recommended a bundle of supportive measures in high-risk patients. In a single-centre trial, we recently demonstrated that the strict implementation of the KDIGO bundle significantly reduced the occurrence of AKI after cardiac surgery. In this feasibility study, we aim to evaluate whether the study protocol can be implemented in a multicentre setting in preparation for a large multicentre trial. METHODS AND ANALYSIS We plan to conduct a prospective, observational survey followed by a randomised controlled, multicentre, multinational clinical trial including 280 patients undergoing cardiac surgery with cardiopulmonary bypass. The purpose of the observational survey is to explore the adherence to the KDIGO recommendations in routine clinical practice. The second phase is a randomised controlled trial. The objective is to investigate whether the trial protocol is implementable in a large multicentre, multinational setting. The primary endpoint of the interventional part is the compliance rate with the protocol. Secondary endpoints include the occurrence of any AKI and moderate/severe AKI as defined by the KDIGO criteria within 72 hours after surgery, renal recovery at day 90, use of renal replacement therapy (RRT) and mortality at days 30, 60 and 90, the combined endpoint major adverse kidney events consisting of persistent renal dysfunction, RRT and mortality at day 90 and safety outcomes. ETHICS AND DISSEMINATION The PrevAKI multicentre study has been approved by the leading Research Ethics Committee of the University of Münster and the respective Research Ethics Committee at each participating site. The results will be used to design a large, definitive trial. TRIAL REGISTRATION NUMBER NCT03244514.",2020,"Secondary endpoints include the occurrence of any AKI and moderate/severe AKI as defined by the KDIGO criteria within 72 hours after surgery, renal recovery at day 90, use of renal replacement therapy (RRT) and mortality at days 30, 60 and 90, the combined endpoint major adverse kidney events consisting of persistent renal dysfunction, RRT and mortality at day 90 and safety outcomes. ETHICS AND DISSEMINATION ","['patients after cardiac surgery (PrevAKI-multicentre', 'high-risk patients', 'Kidney Disease', '280 patients undergoing cardiac surgery with cardiopulmonary bypass']",[],"['occurrence of any AKI and moderate/severe AKI as defined by the KDIGO criteria within 72 hours after surgery, renal recovery at day 90, use of renal replacement therapy (RRT) and mortality', 'combined endpoint major adverse kidney events consisting of persistent renal dysfunction, RRT and mortality at day 90 and safety outcomes.\nETHICS AND DISSEMINATION', 'occurrence of AKI', 'compliance rate with the protocol']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0022658', 'cui_str': 'Kidney disease'}, {'cui': 'C0007202', 'cui_str': 'Cardiopulmonary bypass operation'}]",[],"[{'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C1292423', 'cui_str': '72 hours'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0206074', 'cui_str': 'Renal replacement therapy'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C1565489', 'cui_str': 'Renal impairment'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0015000', 'cui_str': 'Ethics'}, {'cui': 'C0205221', 'cui_str': 'Disseminated'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]",280.0,0.211025,"Secondary endpoints include the occurrence of any AKI and moderate/severe AKI as defined by the KDIGO criteria within 72 hours after surgery, renal recovery at day 90, use of renal replacement therapy (RRT) and mortality at days 30, 60 and 90, the combined endpoint major adverse kidney events consisting of persistent renal dysfunction, RRT and mortality at day 90 and safety outcomes. ETHICS AND DISSEMINATION ","[{'ForeName': 'Mira', 'Initials': 'M', 'LastName': 'Küllmar', 'Affiliation': 'Anesthesiology, Intensive Care and Pain Medicine, Universitatsklinikum Munster, Munster, Nordrhein-Westfalen, Germany.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Massoth', 'Affiliation': 'Anesthesiology, Intensive Care and Pain Medicine, Universitatsklinikum Munster, Munster, Nordrhein-Westfalen, Germany.'}, {'ForeName': 'Marlies', 'Initials': 'M', 'LastName': 'Ostermann', 'Affiliation': ""Department of Critical Care, King's College London, Guy's & St Thomas' Hospital, London, UK.""}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Campos', 'Affiliation': ""Department of Critical Care, King's College London, Guy's & St Thomas' Hospital, London, UK.""}, {'ForeName': 'Neus', 'Initials': 'N', 'LastName': 'Grau Novellas', 'Affiliation': ""Department of Critical Care, King's College London, Guy's & St Thomas' Hospital, London, UK.""}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Thomson', 'Affiliation': ""Department of Critical Care, King's College London, Guy's & St Thomas' Hospital, London, UK.""}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Haffner', 'Affiliation': ""Department of Critical Care, King's College London, Guy's & St Thomas' Hospital, London, UK.""}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Arndt', 'Affiliation': 'Department of Anesthesiology and Operative Intensive Care, University Hospital Marburg, Marburg, UK.'}, {'ForeName': 'Hinnerk', 'Initials': 'H', 'LastName': 'Wulf', 'Affiliation': 'Anesthesiology & Intensive Care Medicine, Philipps-Universitat Marburg Fachbereich Medizin, Marburg, Germany.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Irqsusi', 'Affiliation': 'Department of Cardiothoracic Surgery, Philipps-Universitat Marburg Fachbereich Medizin, Marburg, Germany.'}, {'ForeName': 'Fabrizio', 'Initials': 'F', 'LastName': 'Monaco', 'Affiliation': 'Intensive Care and Anesthesia Unit, Scientific Institute San Raffaele, Milano, Italy.'}, {'ForeName': 'Ambra', 'Initials': 'A', 'LastName': 'Di Prima', 'Affiliation': 'Intensive Care and Anesthesia Unit, Scientific Institute San Raffaele, Milano, Italy.'}, {'ForeName': 'Mercedes', 'Initials': 'M', 'LastName': 'Garcia Alvarez', 'Affiliation': 'Department of Anesthesiology, Hospital de la Santa Creu i Sant Pau, Barcelona, Catalunya, Spain.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Italiano', 'Affiliation': 'Department of Anesthesiology, Hospital de la Santa Creu i Sant Pau, Barcelona, Catalunya, Spain.'}, {'ForeName': 'Virginia', 'Initials': 'V', 'LastName': 'Cegarra SanMartin', 'Affiliation': 'Department of Anesthesiology, Hospital de la Santa Creu i Sant Pau, Barcelona, Catalunya, Spain.'}, {'ForeName': 'Gudrun', 'Initials': 'G', 'LastName': 'Kunst', 'Affiliation': ""Department of Anesthesia, Critical Care and Pain, King's College London, London, UK.""}, {'ForeName': 'Shrijit', 'Initials': 'S', 'LastName': 'Nair', 'Affiliation': ""Department of Anesthesia, Critical Care and Pain, King's College London, London, UK.""}, {'ForeName': 'Camilla', 'Initials': 'C', 'LastName': ""L'Acqua"", 'Affiliation': 'Department of Anesthesia and Critical Care, Centro Cardiologico Monzino IRCCS, Milano, Lombardia, Italy.'}, {'ForeName': 'Eric A J', 'Initials': 'EAJ', 'LastName': 'Hoste', 'Affiliation': 'ICU, Universiteit Gent, Gent, Belgium.'}, {'ForeName': 'Wim', 'Initials': 'W', 'LastName': 'Vandenberghe', 'Affiliation': 'ICU, Universiteit Gent, Gent, Belgium.'}, {'ForeName': 'Patrick M', 'Initials': 'PM', 'LastName': 'Honore', 'Affiliation': 'Department of Intensive Care, CHU Brugmann, Brussels, Belgium.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Kellum', 'Affiliation': 'Center for Critical Care Nephrology, Department of Critical Care Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Lui', 'Initials': 'L', 'LastName': 'Forni', 'Affiliation': 'Department of Intensive Care Medicine, Royal Surrey County Hospital NHS Trust, Guildford, Surrey, UK.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Grieshaber', 'Affiliation': 'Department of Cardiac Surgery, Justus Liebig Universität Giessen Fachbereich Medizin, Giessen, Hessen, Germany.'}, {'ForeName': 'Raphael', 'Initials': 'R', 'LastName': 'Weiss', 'Affiliation': 'Department of Anaesthesiology, University Hospital Münster, Münster, Germany.'}, {'ForeName': 'Joachim', 'Initials': 'J', 'LastName': 'Gerss', 'Affiliation': 'Institute of Biostatistics and Clinical Research, Westfälische Wilhelms-Universität Münster, Münster, Germany.'}, {'ForeName': 'Carola', 'Initials': 'C', 'LastName': 'Wempe', 'Affiliation': 'Anesthesiology, Intensive Care and Pain Medicine, Universitatsklinikum Munster, Munster, Nordrhein-Westfalen, Germany.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Meersch', 'Affiliation': 'Anesthesiology, Intensive Care and Pain Medicine, Universitatsklinikum Munster, Munster, Nordrhein-Westfalen, Germany.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Zarbock', 'Affiliation': 'Anesthesiology, Intensive Care and Pain Medicine, Universitatsklinikum Munster, Munster, Nordrhein-Westfalen, Germany zarbock@uni-muenster.de.'}]",BMJ open,['10.1136/bmjopen-2019-034201'] 393,32266595,Dynamic prediction of cancer-specific survival for primary hypopharyngeal squamous cell carcinoma.,"OBJECTIVES This study investigated a large cohort of patients to construct a predictive nomogram and a web-based survival rate calculator for dynamically predicting the cancer-specific survival of patients with primary hypopharyngeal squamous cell carcinoma (HSCC). METHODS Patients (n = 2007) initially diagnosed with primary HSCC from 2004 to 2015 were extracted from the Surveillance, Epidemiology, and End Results (SEER) database. All patients were randomly divided into the training and validation cohorts (1:1). The Lasso Cox regression model was applied to identify independent risk factors of cancer-specific survival for a predictive nomogram and a web-based calculator. The model was evaluated by concordance index, calibration, and decision curve analysis. RESULTS Cancer-specific survival rates decreased with time, while 3-year conditional survival increased. Cancer-specific deaths evolved from relatively high within the first 3 years to low thereafter. Age, race, T stage, N stage, M stage, surgery, radiotherapy, chemotherapy, and marital status were identified as independent risk factors. We constructed a predictive nomogram for survival and a web-based calculator ( https://linzhongyang.shinyapps.io/Hypopharyngeal/ ). Additionally, a prognostic risk stratification was developed according to nomogram total points. CONCLUSIONS Patients with primary HSCC were found at a high risk of cancer-specific death during the first 3 years, indicating that additional effective follow-up strategies should be implemented over the period. This is the first study to construct a predictive nomogram and a web-based calculator for all patients with HSCC.",2020,The Lasso Cox regression model was applied to identify independent risk factors of cancer-specific survival for a predictive nomogram and a web-based calculator.,"['patients with primary hypopharyngeal squamous cell carcinoma (HSCC', 'Patients with primary HSCC', 'Patients (n\u2009=\u20092007) initially diagnosed with primary HSCC from 2004 to 2015 were extracted from the Surveillance, Epidemiology, and End Results (SEER) database', 'primary hypopharyngeal squamous cell carcinoma', 'patients with HSCC']",[],"['3-year conditional survival', 'Cancer-specific survival rates', 'Cancer-specific deaths', 'cancer-specific death']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0280321', 'cui_str': 'Squamous cell carcinoma of the hypopharynx'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0220920', 'cui_str': 'surveillance'}, {'cui': 'C0014507', 'cui_str': 'Epidemiology'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}]",[],"[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",2015.0,0.0289534,The Lasso Cox regression model was applied to identify independent risk factors of cancer-specific survival for a predictive nomogram and a web-based calculator.,"[{'ForeName': 'Zhongyang', 'Initials': 'Z', 'LastName': 'Lin', 'Affiliation': 'Department of Otolaryngology, The First Affiliated Hospital of Fujian Medical University, No. 20 Chazhong Road, Fuzhou, 350005, Fujian, China.'}, {'ForeName': 'Hanqing', 'Initials': 'H', 'LastName': 'Lin', 'Affiliation': 'Department of Otolaryngology, Eye Ear Nose and Throat Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Chang', 'Initials': 'C', 'LastName': 'Lin', 'Affiliation': 'Department of Otolaryngology, The First Affiliated Hospital of Fujian Medical University, No. 20 Chazhong Road, Fuzhou, 350005, Fujian, China. linc301@yahoo.com.'}]",International journal of clinical oncology,['10.1007/s10147-020-01671-4'] 394,30767563,Novel Prevention Procedure for Inguinal Hernia after Robot-Assisted Radical Prostatectomy: Results from a Prospective Randomized Trial.,"OBJECTIVE To conduct a prospective randomized trial to evaluate the efficacy of a novel prophylactic procedure for inguinal hernia (IH) after transperitoneal robot-assisted radical prostatectomy (RARP). METHODS The prophylactic procedure for IH after RARP involved the dissection of the peritoneum ∼5 cm outward from internal inguinal ring (IIR), separating the spermatic cord and vessels from the peritoneum. This was randomly performed on one side (left or right). RESULTS A total of 148 cases were included, and IH after RARP was observed in 19 (12.8%) cases, with 11 (7.4%) cases in the right side only, 3 (2.0%) in the left side only, and 5 (3.4%) bilaterally. IHs developed in 9 (6.1%) sides that underwent prophylactic procedure and in 15 (10.1%) that did not. Kaplan-Meier curve analysis revealed no significant difference between the preventive and nonpreventive sides (p = 0.197). Based on the observation during laparoscopic hernioplasty, the prophylactic procedure that strengthened the abdominal wall was by adhesion conglutination of the exfoliated peritoneum in the effective side, and IIRs were opened and developed IH in the ineffective sides. Predictive factors for IH after RARP were not found using Cox proportional hazard model. CONCLUSION The preventive procedure for IH used in this study reduced the incidence of IH after RARP, but the difference was not significant.",2019,Kaplan-Meier curve analysis revealed no significant difference between the preventive and nonpreventive sides (p = 0.197).,['Inguinal Hernia after Robot-Assisted Radical Prostatectomy'],"['transperitoneal robot-assisted radical prostatectomy (RARP', 'novel prophylactic procedure']",['inguinal hernia (IH'],"[{'cui': 'C0019294', 'cui_str': 'Hernia, Inguinal'}, {'cui': 'C0336537', 'cui_str': 'Robot, device (physical object)'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0194810', 'cui_str': 'Radical prostatectomy (procedure)'}]","[{'cui': 'C0205501', 'cui_str': 'Transperitoneal approach (qualifier value)'}, {'cui': 'C0336537', 'cui_str': 'Robot, device (physical object)'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0194810', 'cui_str': 'Radical prostatectomy (procedure)'}, {'cui': 'C0445202', 'cui_str': 'Prophylactic (qualifier value)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}]","[{'cui': 'C0019294', 'cui_str': 'Hernia, Inguinal'}]",148.0,0.0372248,Kaplan-Meier curve analysis revealed no significant difference between the preventive and nonpreventive sides (p = 0.197).,"[{'ForeName': 'Yoshifumi', 'Initials': 'Y', 'LastName': 'Kadono', 'Affiliation': 'Department of Integrative Cancer Therapy and Urology, Graduate School of Medical Sciences, Kanazawa University, Kanazawa, Japan.'}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Nohara', 'Affiliation': 'Department of Integrative Cancer Therapy and Urology, Graduate School of Medical Sciences, Kanazawa University, Kanazawa, Japan.'}, {'ForeName': 'Shohei', 'Initials': 'S', 'LastName': 'Kawaguchi', 'Affiliation': 'Department of Integrative Cancer Therapy and Urology, Graduate School of Medical Sciences, Kanazawa University, Kanazawa, Japan.'}, {'ForeName': 'Jiro', 'Initials': 'J', 'LastName': 'Sakamoto', 'Affiliation': 'Department of Integrative Cancer Therapy and Urology, Graduate School of Medical Sciences, Kanazawa University, Kanazawa, Japan.'}, {'ForeName': 'Hiroaki', 'Initials': 'H', 'LastName': 'Iwamoto', 'Affiliation': 'Department of Integrative Cancer Therapy and Urology, Graduate School of Medical Sciences, Kanazawa University, Kanazawa, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Yaegashi', 'Affiliation': 'Department of Integrative Cancer Therapy and Urology, Graduate School of Medical Sciences, Kanazawa University, Kanazawa, Japan.'}, {'ForeName': 'Kazufumi', 'Initials': 'K', 'LastName': 'Nakashima', 'Affiliation': 'Department of Integrative Cancer Therapy and Urology, Graduate School of Medical Sciences, Kanazawa University, Kanazawa, Japan.'}, {'ForeName': 'Masashi', 'Initials': 'M', 'LastName': 'Iijima', 'Affiliation': 'Department of Integrative Cancer Therapy and Urology, Graduate School of Medical Sciences, Kanazawa University, Kanazawa, Japan.'}, {'ForeName': 'Kazuyoshi', 'Initials': 'K', 'LastName': 'Shigehara', 'Affiliation': 'Department of Integrative Cancer Therapy and Urology, Graduate School of Medical Sciences, Kanazawa University, Kanazawa, Japan.'}, {'ForeName': 'Kouji', 'Initials': 'K', 'LastName': 'Izumi', 'Affiliation': 'Department of Integrative Cancer Therapy and Urology, Graduate School of Medical Sciences, Kanazawa University, Kanazawa, Japan.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Mizokami', 'Affiliation': 'Department of Integrative Cancer Therapy and Urology, Graduate School of Medical Sciences, Kanazawa University, Kanazawa, Japan.'}]",Journal of endourology,['10.1089/end.2018.0898'] 395,32267601,A reduced healing protocol for sinus floor elevation in a staged approach with deproteinized bovine bone mineral alone: A randomized controlled clinical trial of a 5-month healing in comparison to the 8-month healing.,"PURPOSE To investigate the feasibility of reducing the healing time of maxillary sinus floor elevation (MSFE) by a two-stage approach using deproteinized bovine bone mineral (DBBM) alone, based on clinical, histomorphometric, and microradiographic evaluations. MATERIALS AND METHODS Twenty consecutive cases with an atrophic posterior edentulous maxilla were randomly assigned to two groups at a ratio of 1:1. The lateral window approach to MSFE with DBBM alone was followed by an 8-month bone-healing period in the control group compared to 5 months in the test group. During implant placement, bone biopsies were harvested from implant osteotomy sites for micro-computed tomography (CT), histological, and histomorphometric evaluations. Cone beam CT (CBCT) scans were performed before and immediately after MSFE and after the bone-healing periods. The implant stability quotient (ISQ) was measured sequentially at implant placement and 1, 3, and 6 months thereafter. RESULTS The histomorphometric and microradiographic results showed no significant differences in new bone formation on the augmented sinus floor between the two groups (all Ps > .05), except that trabecular thickness was significantly reduced and trabecular separation significantly increased in the test group (both Ps < .05). The ISQs of both groups increased continuously after implant placement, but the difference was not significant between the groups at each time point. CBCT analyses showed that the extent of volumetric loss was comparable after bone healing for 5 and 8 months (P > .05). CONCLUSIONS Within the limitations of this study, the bone-healing time of MSFE with DBBM alone for staged implant placement could be reduced to 5 months instead of 8 or 9 months, based on the histomorphometric, microradiographic, and clinical outcomes; however, impact on long-term implant survival remains unknown and needs further investigation with long-term follow-ups.",2020,"The histomorphometric and microradiographic results showed no significant differences in new bone formation on the augmented sinus floor between the two groups (all Ps > .05), except that trabecular thickness was significantly reduced and trabecular separation significantly increased in the test group (both Ps < .05).",['Twenty consecutive cases with an atrophic posterior edentulous maxilla'],"['deproteinized bovine bone mineral (DBBM', 'deproteinized bovine bone mineral alone', 'Cone beam CT (CBCT) scans']","['trabecular thickness', 'trabecular separation', 'implant stability quotient (ISQ', 'volumetric loss', 'new bone formation', 'healing time of maxillary sinus floor elevation (MSFE']","[{'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0333641', 'cui_str': 'Atrophy'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0026644', 'cui_str': 'Edentulous'}, {'cui': 'C0024947', 'cui_str': 'Bone structure of maxilla'}]","[{'cui': 'C0007452', 'cui_str': 'Cattle'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0006660', 'cui_str': 'Physiologic Calcification'}, {'cui': 'C1956110', 'cui_str': 'Cone beam CT'}]","[{'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0036679', 'cui_str': 'Separation'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0445383', 'cui_str': 'Volumetric'}, {'cui': 'C0334168', 'cui_str': 'New bone formation'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0024957', 'cui_str': 'Maxillary sinus structure'}, {'cui': 'C0016249', 'cui_str': 'Walking surface of room'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}]",20.0,0.0236259,"The histomorphometric and microradiographic results showed no significant differences in new bone formation on the augmented sinus floor between the two groups (all Ps > .05), except that trabecular thickness was significantly reduced and trabecular separation significantly increased in the test group (both Ps < .05).","[{'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': ""Department of Oral Implants, School of Stomatology, State Key Laboratory of Military Stomatology, The Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': ""Department of Oral Implants, School of Stomatology, State Key Laboratory of Military Stomatology, The Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Chen', 'Affiliation': ""Department of Oral Implants, School of Stomatology, State Key Laboratory of Military Stomatology, The Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Feng', 'Affiliation': ""Department of Oral Implants, School of Stomatology, State Key Laboratory of Military Stomatology, The Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Xie', 'Affiliation': ""Department of Oral Implants, School of Stomatology, State Key Laboratory of Military Stomatology, The Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Dehua', 'Initials': 'D', 'LastName': 'Li', 'Affiliation': ""Department of Oral Implants, School of Stomatology, State Key Laboratory of Military Stomatology, The Fourth Military Medical University, Xi'an, China.""}]",Clinical implant dentistry and related research,['10.1111/cid.12906'] 396,30793924,Ureteral Catheter Versus Nephrostomy Tube for Patients Undergoing Percutaneous Nephrolithotomy Under Spinal Anesthesia: A Prospectively Randomized Trial.,"PURPOSE The aim of this study is to evaluate overnight ureteral catheterization vs nephrostomy tube for urinary diversion in patients undergoing percutaneous nephrolithotomy (PNL) under spinal anesthesia. MATERIALS AND METHODS Patients were enrolled using block randomization between February 2016 and July 2016. Patients with renal stones >2 cm confirmed via noncontrast-enhanced CT were included. All patients underwent PNL under spinal anesthesia. Group 1 refers to patients who had a nephrostomy tube following PNL, whereas group 2 refers to overnight ureteral catheterization. Those who refuse spinal anesthesia, <18 years of age, >70 years of age, and anomalous kidneys (ectopic pelvic kidney, horseshoe kidney, etc.) were excluded. In group 1, nephrostomy tube (14F) was removed 48 hours after surgery, whereas the ureteral catheter (6F) was removed at postoperative 12th hour in group 2. Visual analogue scores (VASs) at 24th hour and mean narcotic analgesic (tramadol) amounts were compared. RESULTS There were 30 patients in both groups. Mean age, mean body mass index, and stone area were not significant between groups (p > 0.05, for all). With regard to operative measures, mean duration of surgery, mean number of accesses, and mean drop in Hb levels were comparable. Besides, mean hospitalization period in group 1 was 68.8 ± 12 hours, whereas it was 54.5 ± 10 hours in group 2 (p < 0.001). No patients in either group needed transfusion. Stone-free rates were similar in both groups (83% vs 90%, p = 0.391). Mean 24th hour VAS was 6.17 ± 1.4 in group 1 and 3.37 ± 1.4 in group 2 (p < 0.001). Also, there was a statistically significant difference in mean tramadol requirements between groups (181.67 ± 56.45 vs 86.67 ± 57.13, groups 1 and 2, respectively). CONCLUSION In patients undergoing PNL under spinal anesthesia, using an open-ended ureteral catheter to be removed at early postoperative period reduces analgesic requirement and duration of hospital stay without compromising surgical outcomes and complication rates.",2019,"Stone-free rates were similar in both groups (83% vs 90%, p = 0.391).","['patients undergoing percutaneous nephrolithotomy (PNL) under spinal anesthesia', 'patients undergoing PNL under spinal anesthesia', 'Patients Undergoing Percutaneous Nephrolithotomy', 'Those who refuse spinal anesthesia, <18 years of age, >70 years of age, and anomalous kidneys (ectopic pelvic kidney, horseshoe kidney, etc.) were excluded', 'Under Spinal Anesthesia', 'All patients underwent PNL under spinal anesthesia', 'Patients were enrolled using block randomization between February 2016 and July 2016', 'Patients with renal stones >2\u2009cm confirmed via noncontrast-enhanced CT were included']","['nephrostomy tube (14F', 'overnight ureteral catheterization vs nephrostomy tube for urinary diversion', 'overnight ureteral catheterization', 'Ureteral Catheter Versus Nephrostomy Tube', 'nephrostomy tube following PNL']","['Mean age, mean body mass index, and stone area', 'Mean 24th hour VAS', 'mean tramadol requirements', 'mean hospitalization period', 'analgesic requirement and duration of hospital stay without compromising surgical outcomes and complication rates', 'operative measures, mean duration of surgery, mean number of accesses, and mean drop in Hb levels', 'Stone-free rates', 'transfusion', 'Visual analogue scores (VASs) at 24th hour and mean narcotic analgesic (tramadol']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0162428', 'cui_str': 'Nephrolithotomy, Percutaneous'}, {'cui': 'C0002928', 'cui_str': 'Spinal Anesthesia'}, {'cui': 'C1705116', 'cui_str': 'Refused (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0022646', 'cui_str': 'Kidney'}, {'cui': 'C0340464', 'cui_str': 'Premature Cardiac Complex'}, {'cui': 'C0221209', 'cui_str': 'Congenital pelvic kidney (disorder)'}, {'cui': 'C0221353', 'cui_str': 'Horseshoe Kidney'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0022650', 'cui_str': 'Kidney Stones'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C0184149', 'cui_str': 'Nephrostomy tube (physical object)'}, {'cui': 'C0439583', 'cui_str': 'Overnight (qualifier value)'}, {'cui': 'C0041953', 'cui_str': 'Catheterization, Ureteral'}, {'cui': 'C0042020', 'cui_str': 'Urinary Diversion'}, {'cui': 'C0179799', 'cui_str': 'Ureteral Catheters'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0006736', 'cui_str': 'Biliary or Urinary Stones'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C0040610', 'cui_str': 'Tramadol'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C4318619', 'cui_str': 'Drop (unit of presentation)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0199960', 'cui_str': 'Transfusion - action (qualifier value)'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0027409', 'cui_str': 'Narcotic Analgesics'}]",,0.0253104,"Stone-free rates were similar in both groups (83% vs 90%, p = 0.391).","[{'ForeName': 'Murat', 'Initials': 'M', 'LastName': 'Gönen', 'Affiliation': '1 Department of Urology, Konya Training and Research Hospital, Konya, Turkey.'}, {'ForeName': 'Ömer Erkam', 'Initials': 'ÖE', 'LastName': 'Arslan', 'Affiliation': '1 Department of Urology, Konya Training and Research Hospital, Konya, Turkey.'}, {'ForeName': 'M İrfan', 'Initials': 'Mİ', 'LastName': 'Dönmez', 'Affiliation': '2 Department of Pediatric Urology, Konya Training and Research Hospital, Konya, Turkey.'}, {'ForeName': 'Ahmed Ömer', 'Initials': 'AÖ', 'LastName': 'Halat', 'Affiliation': '1 Department of Urology, Konya Training and Research Hospital, Konya, Turkey.'}, {'ForeName': 'Tezcan', 'Initials': 'T', 'LastName': 'Sezgin', 'Affiliation': '1 Department of Urology, Konya Training and Research Hospital, Konya, Turkey.'}]",Journal of endourology,['10.1089/end.2018.0875'] 397,30793929,Cystoscopy Real-Time Self-Visualization and Its Impact in Patient's Pain Perception.,"OBJECTIVES To determine if self-visualization of ambulatory cystoscopy provides a decrease in pain perception in male and female patients. METHODS A quasi-randomized controlled trial involving patients scheduled for ambulatory cystoscopy from August to November 2017. The indications were: hematuria, bladder cancer surveillance, lower urinary tract symptoms, and incontinence. The patients were quasi-randomized into two groups by scheduled date. Both groups received the same explanation before and during cystoscopy. The variables analyzed were gender, age, Visual Analog Scale (VAS) score, number of previous cystoscopies, and indication and positivity of the test for bladder neoplasia. All patients were analyzed by group and gender separately. The statistical tests used were: Wilcoxon rank-sum, Kruskal-Wallis, Mann-Whitney U test, Pearson correlation, and linear regression. RESULTS Four hundred four patients were included (318 males and 86 females) and divided into two groups, group A (no self-visualization, n = 239) and group B (self-visualization, n = 165). In males, mean VAS score was 2.6 for group A and 2.5 for group B (p = 0.276); in females, VAS score was 2.78 for group A and 1.64 for group B (p = 0.008). Regarding the remaining variables analyzed, neither positivity of the test for neoplasia (p = 0.14) nor cystoscopy indication (p = 0.597) had any influence. In patients with two or more previous cystoscopies, a reduction in mean VAS score was seen in both genders. In males having their first cystoscopy the mean VAS score was 3.1 and decreased to 2.1 for the third or more (p = 0.001); in females the mean VAS score was 2.89 for the first and 1.56 for the third or more (p = 0.02), although this benefit tended to disappear when the number of previous cystoscopies was taken into account. CONCLUSION In male patients, self-visualization of cystoscopy did not impact pain perception, while in female patients, it seemed to provide a benefit. The number of previous cystoscopies had an influence, diminishing the perception of pain, regardless of whether the patient visualized the procedure or not.",2019,"In patients with two or more previous cystoscopies, a reduction in mean VAS score was seen in both genders.","[""Patient's Pain Perception"", 'Four hundred four patients were included (318 males and 86 females', 'male and female patients', 'patients scheduled for ambulatory cystoscopy from August to November 2017']",['ambulatory cystoscopy'],"['hematuria, bladder cancer surveillance, lower urinary tract symptoms, and incontinence', 'Wilcoxon rank-sum, Kruskal-Wallis, Mann-Whitney U test, Pearson correlation, and linear regression', 'pain perception', 'VAS score', 'Visual Analog Scale (VAS) score, number of previous cystoscopies, and indication and positivity of the test for bladder neoplasia', 'mean VAS score']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3714605', 'cui_str': 'Pain Perception'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0030703', 'cui_str': 'Schedules, Patient'}, {'cui': 'C0439841', 'cui_str': 'Ambulatory'}, {'cui': 'C0010702', 'cui_str': 'Cystoscopy'}]","[{'cui': 'C0439841', 'cui_str': 'Ambulatory'}, {'cui': 'C0010702', 'cui_str': 'Cystoscopy'}]","[{'cui': 'C0018965', 'cui_str': 'Hematuria'}, {'cui': 'C0005684', 'cui_str': 'Malignant Tumor of Urinary Bladder'}, {'cui': 'C0733511', 'cui_str': 'Surveillance (regime/therapy)'}, {'cui': 'C0574785', 'cui_str': 'Lower Urinary Tract Symptoms'}, {'cui': 'C0021167', 'cui_str': 'Incontinence (finding)'}, {'cui': 'C0699794', 'cui_str': 'Rank (attribute)'}, {'cui': 'C0242927', 'cui_str': 'Mann-Whitney U Test'}, {'cui': 'C0023733', 'cui_str': 'Linear Regression'}, {'cui': 'C3714605', 'cui_str': 'Pain Perception'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0010702', 'cui_str': 'Cystoscopy'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0005682', 'cui_str': 'Bladder'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",404.0,0.0318413,"In patients with two or more previous cystoscopies, a reduction in mean VAS score was seen in both genders.","[{'ForeName': 'Daniel A', 'Initials': 'DA', 'LastName': 'González-Padilla', 'Affiliation': '1 Department of Urology, University Hospital 12 de Octubre, Madrid, Spain.'}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'González-Díaz', 'Affiliation': '1 Department of Urology, University Hospital 12 de Octubre, Madrid, Spain.'}, {'ForeName': 'Borja', 'Initials': 'B', 'LastName': 'García-Gómez', 'Affiliation': '1 Department of Urology, University Hospital 12 de Octubre, Madrid, Spain.'}, {'ForeName': 'Felipe', 'Initials': 'F', 'LastName': 'Villacampa-Aubá', 'Affiliation': '2 Department of Urology, University Clinic of Navarra, Madrid, Spain.'}, {'ForeName': 'Natalia', 'Initials': 'N', 'LastName': 'Miranda-Utrera', 'Affiliation': '1 Department of Urology, University Hospital 12 de Octubre, Madrid, Spain.'}, {'ForeName': 'Alfredo', 'Initials': 'A', 'LastName': 'Rodríguez-Antolín', 'Affiliation': '1 Department of Urology, University Hospital 12 de Octubre, Madrid, Spain.'}, {'ForeName': 'Félix', 'Initials': 'F', 'LastName': 'Guerrero-Ramos', 'Affiliation': '1 Department of Urology, University Hospital 12 de Octubre, Madrid, Spain.'}]",Journal of endourology,['10.1089/end.2018.0768'] 398,32252983,Telemedicine to follow patients in a general surgery department. A randomized controlled trial.,"BACKGROUND Telemedicine is becoming more popular in many medical specialties but few studies have been conducted in General Surgery. This study aims to evaluate the feasibility of its introduction in this specialty. METHODS A prospective randomized clinical trial (RCT) was conducted in 200 patients to compare conventional vs telemedicine follow-up in the outpatient clinics. The primary outcome was the feasibility of telemedicine follow-up and the secondary outcomes were its clinical impact and patient satisfaction. RESULTS Patients were enrolled between March 2017 and April 2018 and there were no statistically significant differences between the groups' characteristics. The primary outcome was achieved in 90% of the conventional follow-up group and in 74% of the telemedicine group (P = 0.003). No differences were found in clinical outcomes (P = 0.832) or patient satisfaction (P = 0.099). CONCLUSION Telemedicine is a good complementary service to facilitate follow-up management in selected patients from a General Surgery department.",2020,The primary outcome was achieved in 90% of the conventional follow-up group and in 74% of the telemedicine group (P = 0.003).,"['selected patients from a General Surgery department', '200 patients to compare conventional vs telemedicine follow-up in the outpatient clinics']","['telemedicine', 'Telemedicine']","['patient satisfaction', 'clinical outcomes', 'clinical impact and patient satisfaction', 'feasibility of telemedicine follow-up and the secondary outcomes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1274039', 'cui_str': 'General surgery'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}]","[{'cui': 'C0162648', 'cui_str': 'Telemedicine'}]","[{'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}]",,0.181944,The primary outcome was achieved in 90% of the conventional follow-up group and in 74% of the telemedicine group (P = 0.003).,"[{'ForeName': 'Manel', 'Initials': 'M', 'LastName': 'Cremades', 'Affiliation': 'General Surgery, Hospital Universitari Germans Trias I Pujol, Spain. Electronic address: cirurgiageneral.germanstrias@gencat.cat.'}, {'ForeName': 'Georgina', 'Initials': 'G', 'LastName': 'Ferret', 'Affiliation': 'General Surgery, Hospital Universitari Doctor Josep Trueta, Spain.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Parés', 'Affiliation': 'General Surgery, Hospital Universitari Germans Trias I Pujol, Spain.'}, {'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Navinés', 'Affiliation': 'General Surgery, Hospital Universitari Germans Trias I Pujol, Spain.'}, {'ForeName': 'Franc', 'Initials': 'F', 'LastName': 'Espin', 'Affiliation': 'General Surgery, Hospital Universitari Germans Trias I Pujol, Spain.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Pardo', 'Affiliation': 'General Surgery, Hospital Universitari Germans Trias I Pujol, Spain.'}, {'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Caballero', 'Affiliation': 'General Surgery, Hospital Universitari Germans Trias I Pujol, Spain.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Viciano', 'Affiliation': 'General Surgery, Hospital Universitari Germans Trias I Pujol, Spain.'}, {'ForeName': 'Joan Francesc', 'Initials': 'JF', 'LastName': 'Julian', 'Affiliation': 'General Surgery, Hospital Universitari Germans Trias I Pujol, Spain.'}]",American journal of surgery,['10.1016/j.amjsurg.2020.03.023'] 399,32255212,Influence of a customized three-dimensionally printed drill guide on the accuracy of pedicle screw placement in lumbosacral vertebrae: An ex vivo study.,"OBJECTIVE To compare the accuracy of pedicle screw insertion (PSI) into canine lumbosacral vertebrae with custom-made three-dimensionally (3D)-printed drill guides or freehand insertion. STUDY DESIGN Ex vivo study. SAMPLE POPULATION Nineteen canine lumbosacral specimens. METHODS Drill guides for PSI were designed on the basis of safe screw insertion trajectories by using preoperative computed tomography (CT) and produced by 3D printing of templates. Right and left sides of the specimens were randomly allocated to two groups; 4-mm pedicle screws were inserted in L5-L6 and L7-S1 spinal segments either freehand (control group) or with custom-made drill guides (guide group). Sixty-six screws were inserted with each method. Insertion angles (α, β), bone stock, and vertebral canal breach were assessed according to postoperative CT. χ 2 Tests were used to compare vertebral canal breach between groups and vertebrae. RESULTS Breaches in the vertebral canal were less common (P < .001) when screws were placed with a guide in the guide group (9/66, 14%) than without a guide (30/66, 45%). The rate of vertebral canal breach differed at L5 (P = .021) but not at L6 (P = .05), L7 (P = .075) or S1 (P = .658). The angle of insertion (α) did not differ between specimens with and without breaches (guide, P = .068; control, P = .394). CONCLUSION The use of a customized 3D-printed guide generally improved the accuracy of PSI in canine lumbosacral vertebrae, although statistical significance was reached only at L5. CLINICAL SIGNIFICANCE The use of customized drill guides may be considered as an alternative to freehand PSI in the lumbosacral area, especially for L5-L6 vertebrae.",2020,"The rate of vertebral canal breach differed at L5 (P = .021) but not at L6 (P = .05), L7 (P = .075) or S1 (P = .658).","['Nineteen canine lumbosacral specimens', 'lumbosacral vertebrae']","['preoperative computed tomography (CT', '4-mm pedicle screws were inserted in L5-L6 and L7-S1 spinal segments either freehand (control group) or with custom-made drill guides (guide group', 'pedicle screw insertion (PSI) into canine lumbosacral vertebrae with custom-made three-dimensionally (3D)-printed drill guides or freehand insertion', 'pedicle screw placement']","['rate of vertebral canal breach', 'accuracy of PSI in canine lumbosacral vertebrae', 'vertebral canal breach', 'Insertion angles (α, β), bone stock, and vertebral canal breach', 'angle of insertion (α']","[{'cui': 'C0450337', 'cui_str': '19'}, {'cui': 'C0010482', 'cui_str': 'Structure of canine tooth'}, {'cui': 'C0450206', 'cui_str': 'Lumbosacral'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0223603', 'cui_str': 'Structure of lumbosacral vertebrae'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C1961768', 'cui_str': 'Pedicle Screws'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0441635', 'cui_str': 'Segment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0162343', 'cui_str': 'Customs'}, {'cui': 'C0324815', 'cui_str': 'Mandrillus leucophaeus'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0010482', 'cui_str': 'Structure of canine tooth'}, {'cui': 'C0223603', 'cui_str': 'Structure of lumbosacral vertebrae'}, {'cui': 'C0033161', 'cui_str': 'Printing'}]","[{'cui': 'C0037922', 'cui_str': 'Spinal canal structure'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0439472', 'cui_str': 'lb/sq. in'}, {'cui': 'C0010482', 'cui_str': 'Structure of canine tooth'}, {'cui': 'C0223603', 'cui_str': 'Structure of lumbosacral vertebrae'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0453908', 'cui_str': 'Stocking'}]",66.0,0.0278726,"The rate of vertebral canal breach differed at L5 (P = .021) but not at L6 (P = .05), L7 (P = .075) or S1 (P = .658).","[{'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Beer', 'Affiliation': 'Clinic for Small Animal Surgery, Vetsuisse Faculty University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Brian H', 'Initials': 'BH', 'LastName': 'Park', 'Affiliation': 'Clinic for Small Animal Surgery, Vetsuisse Faculty University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Steffen', 'Affiliation': 'Clinic for Small Animal Surgery, Vetsuisse Faculty University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Decvn Lucas A', 'Initials': 'DLA', 'LastName': 'Smolders', 'Affiliation': 'Clinic for Small Animal Surgery, Vetsuisse Faculty University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Pozzi', 'Affiliation': 'Clinic for Small Animal Surgery, Vetsuisse Faculty University of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Sebastian C', 'Initials': 'SC', 'LastName': 'Knell', 'Affiliation': 'Clinic for Small Animal Surgery, Vetsuisse Faculty University of Zurich, Zurich, Switzerland.'}]",Veterinary surgery : VS,['10.1111/vsu.13417'] 400,32253894,"A multi-modal exercise intervention that improves cognitive function and physical performance, elderly with mobility-related disability: a randomized controlled trial.","BACKGROUND Physical exercise interventions have showed improvement on cognitive performance and mobility of old people. However, the results regarding the inclusion of cognitive activities into exercise were not evaluated simultaneously. Therefore, the aim of this study was to investigate the effect of multimodal exercise program on cognitive function and physical performance in elderly people with mobility disabilities. METHODS The sample of the study consisted of 70 old people randomly appointed to the exercise and control groups (35 people for each) with mobility disabilities. A new exercise program was conducted for old people in the exercise group for 6 months. Evaluation between 1st and 24th week included cognitive change, mobility, balance and walking parameters. RESULTS Exercise group showed better performance on orientation, memory and language point than before the intervention (P<0.05). Again, the total mental test score of the exercise group significantly increased from 18.7±3.5 to 20.1±3.5 after the intervention (P<0.001). People without a cognitive disorder increased from 8 to 11 in the exercise group (P<0.001), while the number did not change in control group. Correlation was found between exercise group and activities such as mobility, walking and balance performance (r=0.81; P<0.001). CONCLUSIONS A multimodal exercise program with intense mental activities enabled an improvement in both cognitive and physical performance in old people with loss of competences due to mobility.",2020,"RESULTS Exercise group showed better performance on orientation, memory and language point than before the intervention (p<0.05).","['old people in the exercise group for 6 months', 'old people with loss of competences due to mobility', 'elderly people with mobility disabilities', 'elderly with mobility-related disability', '70 old people randomly appointed to the exercise and control groups (35 people for each) with mobility disabilities']","['multimodal exercise program', 'modal exercise intervention', 'Physical exercise interventions', 'new exercise program']","['cognitive and physical performance', 'total mental test score', 'better performance on orientation, memory and language point', 'activities such as mobility, walking and balance performance', 'cognitive disorder', 'cognitive performance and mobility of old people', 'cognitive function and physical performance', 'cognitive change, mobility, balance and walking parameters']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1276393', 'cui_str': 'Group exercise'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205314', 'cui_str': 'New'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0451292', 'cui_str': 'Mental test score'}, {'cui': 'C0205170', 'cui_str': 'Good'}, {'cui': 'C0029266', 'cui_str': 'Orientation'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0009241', 'cui_str': 'Cognitive disorder'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",70.0,0.0554885,"RESULTS Exercise group showed better performance on orientation, memory and language point than before the intervention (p<0.05).","[{'ForeName': 'Serap', 'Initials': 'S', 'LastName': 'Canli', 'Affiliation': 'Department of Elderly Care Program, University of Ankara, Ankara, Turkey - seunal@ankara.edu.tr.'}, {'ForeName': 'Ferda', 'Initials': 'F', 'LastName': 'Ozyurda', 'Affiliation': 'Faculty of Medicine, Department of Internal Medical Sciences, University of Ankara, Ankara, Turkey.'}]",The Journal of sports medicine and physical fitness,['10.23736/S0022-4707.20.10286-X'] 401,31454829,Acute kidney injury risk-based screening in pediatric inpatients: a pragmatic randomized trial.,"BACKGROUND Pediatric acute kidney injury (AKI) is common and associated with increased morbidity, mortality, and length of stay. We performed a pragmatic randomized trial testing the hypothesis that AKI risk alerts increase AKI screening. METHODS All intensive care and ward admissions of children aged 28 days through 21 years without chronic kidney disease from 12/6/2016 to 11/1/2017 were included. The intervention alert displayed if calculated AKI risk was > 50% and no serum creatinine (SCr) was ordered within 24 h. The primary outcome was SCr testing within 48 h of AKI risk > 50%. RESULTS Among intensive care admissions, 973/1909 (51%) were randomized to the intervention. Among those at risk, more SCr tests were ordered for the intervention group than for controls (418/606, 69% vs. 361/597, 60%, p = 0.002). AKI incidence and severity were the same in intervention and control groups. Among ward admissions, 5492/10997 (50%) were randomized to the intervention, and there were no differences between groups in SCr testing, AKI incidence, or severity of AKI. CONCLUSIONS Alerts based on real-time prediction of AKI risk increased screening rates in intensive care but not pediatric ward settings. Pragmatic clinical trials provide the opportunity to assess clinical decision support and potentially eliminate ineffective alerts.",2020,AKI incidence and severity were the same in intervention and control groups.,"['pediatric inpatients', 'All intensive care and ward admissions of children aged 28 days through 21 years without chronic kidney disease from 12/6/2016 to 11/1/2017 were included']",[],"['serum creatinine (SCr', 'SCr tests', 'AKI incidence and severity', 'morbidity, mortality, and length of stay', 'SCr testing within 48\u2009h of AKI risk', 'SCr testing, AKI incidence, or severity of AKI', 'calculated AKI risk']","[{'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0085559'}, {'cui': 'C1305702', 'cui_str': 'Ward (environment)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1561643', 'cui_str': 'Chronic Kidney Diseases'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]",[],"[{'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum (procedure)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",,0.192399,AKI incidence and severity were the same in intervention and control groups.,"[{'ForeName': 'Sara L', 'Initials': 'SL', 'LastName': 'Van Driest', 'Affiliation': 'Department of Pediatrics, Vanderbilt University School of Medicine, Nashville, TN, USA. sara.van.driest@vumc.org.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Department of Biostatistics, Vanderbilt University School of Medicine, Nashville, TN, USA.'}, {'ForeName': 'Michael F', 'Initials': 'MF', 'LastName': 'McLemore', 'Affiliation': 'Health Information Technology, Vanderbilt University School of Medicine, Nashville, TN, USA.'}, {'ForeName': 'Brian C', 'Initials': 'BC', 'LastName': 'Bridges', 'Affiliation': 'Department of Pediatrics, Vanderbilt University School of Medicine, Nashville, TN, USA.'}, {'ForeName': 'Geoffrey M', 'Initials': 'GM', 'LastName': 'Fleming', 'Affiliation': 'Department of Pediatrics, Vanderbilt University School of Medicine, Nashville, TN, USA.'}, {'ForeName': 'Tracy L', 'Initials': 'TL', 'LastName': 'McGregor', 'Affiliation': 'Department of Pediatrics, Vanderbilt University School of Medicine, Nashville, TN, USA.'}, {'ForeName': 'Deborah P', 'Initials': 'DP', 'LastName': 'Jones', 'Affiliation': 'Department of Pediatrics, Vanderbilt University School of Medicine, Nashville, TN, USA.'}, {'ForeName': 'Jana', 'Initials': 'J', 'LastName': 'Shirey-Rice', 'Affiliation': 'Institute for Clinical and Translational Research, Vanderbilt University School of Medicine, Nashville, TN, USA.'}, {'ForeName': 'Cheryl L', 'Initials': 'CL', 'LastName': 'Gatto', 'Affiliation': 'Institute for Clinical and Translational Research, Vanderbilt University School of Medicine, Nashville, TN, USA.'}, {'ForeName': 'James C', 'Initials': 'JC', 'LastName': 'Gay', 'Affiliation': 'Department of Pediatrics, Vanderbilt University School of Medicine, Nashville, TN, USA.'}, {'ForeName': 'Daniel W', 'Initials': 'DW', 'LastName': 'Byrne', 'Affiliation': 'Department of Biostatistics, Vanderbilt University School of Medicine, Nashville, TN, USA.'}, {'ForeName': 'Asli', 'Initials': 'A', 'LastName': 'Weitkamp', 'Affiliation': 'Department of Biomedical Informatics, Vanderbilt University School of Medicine, Nashville, TN, USA.'}, {'ForeName': 'Dan M', 'Initials': 'DM', 'LastName': 'Roden', 'Affiliation': 'Department of Medicine, Vanderbilt University School of Medicine, Nashville, TN, USA.'}, {'ForeName': 'Gordon', 'Initials': 'G', 'LastName': 'Bernard', 'Affiliation': 'Department of Medicine, Vanderbilt University School of Medicine, Nashville, TN, USA.'}]",Pediatric research,['10.1038/s41390-019-0550-1'] 402,32251641,"Safety and immunogenicity of a parenteral trivalent P2-VP8 subunit rotavirus vaccine: a multisite, randomised, double-blind, placebo-controlled trial.","BACKGROUND A monovalent, parenteral, subunit rotavirus vaccine was well tolerated and immunogenic in adults in the USA and in toddlers and infants in South Africa, but elicited poor responses against heterotypic rotavirus strains. We aimed to evaluate safety and immunogenicity of a trivalent vaccine formulation (P2-VP8-P[4],[6],[8]). METHODS A double-blind, randomised, placebo-controlled, dose-escalation, phase 1/2 study was done at three South African research sites. Healthy adults (aged 18-45 years), toddlers (aged 2-3 years), and infants (aged 6-8 weeks, ≥37 weeks' gestation, and without previous receipt of rotavirus vaccination), all without HIV infection, were eligible for enrolment. In the dose-escalation phase, adults and toddlers were randomly assigned in blocks (block size of five) to receive 30 μg or 90 μg of vaccine, or placebo, and infants were randomly assigned in blocks (block size of four) to receive 15 μg, 30 μg, or 90 μg of vaccine, or placebo. In the expanded phase, infants were randomly assigned in a 1:1:1:1 ratio to receive 15 μg, 30 μg, or 90 μg of vaccine, or placebo, in block sizes of four. Participants, parents of participants, and clinical, data, and laboratory staff were masked to treatment assignment. Adults received an intramuscular injection of vaccine or placebo in the deltoid muscle on the day of randomisation (day 0), day 28, and day 56; toddlers received a single injection of vaccine or placebo in the anterolateral thigh on day 0. Infants in both phases received an injection of vaccine or placebo in the anterolateral thigh on days 0, 28, and 56, at approximately 6, 10, and 14 weeks of age. Primary safety endpoints were local and systemic reactions (grade 2 or worse) within 7 days and adverse events and serious adverse events within 28 days after each injection in all participants who received at least one injection. Primary immunogenicity endpoints were analysed in infants in either phase who received all planned injections, had blood samples analysed at the relevant timepoints, and presented no major protocol violations considered to have an effect on the immunogenicity results of the study, and included serum anti-P2-VP8 IgA, IgG, and neutralising antibody geometric mean titres and responses measured 4 weeks after the final injection in vaccine compared with placebo groups. This trial is registered with ClinicalTrials.gov, NCT02646891. FINDINGS Between Feb 15, 2016, and Dec 22, 2017, 30 adults (12 each in the 30 μg and 90 μg groups and six in the placebo group), 30 toddlers (12 each in the 30 μg and 90 μg groups and six in the placebo group), and 557 infants (139 in the 15 μg group, 140 in the 30 μg group, 139 in the 90 μg group, and 139 in the placebo group) were randomly assigned, received at least one dose, and were assessed for safety. There were no significant differences in local or systemic adverse events, or unsolicited adverse events, between vaccine and placebo groups. There were no serious adverse events within 28 days of injection in adults, whereas one serious adverse event occurred in a toddler (febrile convulsion in the 30 μg group) and 23 serious adverse events (four in placebo, ten in 15 μg, four in 30 μg, and five in 90 μg groups) occurred among 20 infants, most commonly respiratory tract infections. One death occurred in an infant within 28 days of injection due to pneumococcal meningitis. In 528 infants (130 in placebo, 132 in 15 μg, 132 in 30 μg, and 134 in 90 μg groups), adjusted anti-P2-VP8 IgG seroresponses (≥4-fold increase from baseline) to P[4], P[6], and P[8] antigens were significantly higher in the 15 μg, 30 μg, and 90 μg groups (99-100%) than in the placebo group (10-29%; p<0·0001). Although significantly higher than in placebo recipients (9-10%), anti-P2-VP8 IgA seroresponses (≥4-fold increase from baseline) to each individual antigen were modest (20-34%) across the 15 μg, 30 μg, and 90 μg groups. Adjusted neutralising antibody seroresponses in infants (≥2·7-fold increase from baseline) to DS-1 (P[4]), 1076 (P[6]), and Wa (P[8]) were higher in vaccine recipients than in placebo recipients: p<0·0001 for all comparisons. INTERPRETATION The trivalent P2-VP8 vaccine was well tolerated, with promising anti-P2-VP8 IgG and neutralising antibody responses across the three vaccine P types. Our findings support advancing the vaccine to efficacy testing. FUNDING Bill & Melinda Gates Foundation.",2020,"There were no significant differences in local or systemic adverse events, or unsolicited adverse events, between vaccine and placebo groups.","['528 infants (130 in', '140 in the 30 μg group, 139 in the 90 μg group, and 139 in the placebo group', ""Healthy adults (aged 18-45 years), toddlers (aged 2-3 years), and infants (aged 6-8 weeks, ≥37 weeks' gestation, and without previous receipt of rotavirus vaccination), all without HIV infection, were eligible for enrolment"", 'adults in the USA and in toddlers and infants in South Africa', 'Between Feb 15, 2016, and Dec 22, 2017, 30 adults (12 each in the 30 μg and 90 μg groups and six in the placebo group), 30 toddlers (12 each in the 30 μg and 90 μg groups and six in the placebo group), and 557 infants (139 in the 15 μg group', 'three South African research sites', 'adults and toddlers']","['vaccine or placebo', 'parenteral trivalent P2-VP8 subunit rotavirus vaccine', 'placebo', 'intramuscular injection of vaccine or placebo', 'vaccine, or placebo', 'blocks (block size of five) to receive 30 μg or 90 μg of vaccine, or placebo, and infants were randomly assigned in blocks (block size of four) to receive 15 μg, 30 μg, or 90 μg of vaccine, or placebo', 'trivalent vaccine formulation (P2-VP8-P[4],[6],[8']","['serum anti-P2-VP8 IgA, IgG, and neutralising antibody geometric mean titres and responses', 'serious adverse events', 'One death', 'local or systemic adverse events, or unsolicited adverse events', 'safety and immunogenicity', 'Safety and immunogenicity', '23 serious adverse events', 'Adjusted neutralising antibody seroresponses', 'local and systemic reactions (grade 2 or worse) within 7 days and adverse events and serious adverse events', 'adjusted anti-P2-VP8 IgG seroresponses', 'anti-P2-VP8 IgA seroresponses']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C5191072', 'cui_str': '139'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0682053', 'cui_str': 'Toddler'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C1532786', 'cui_str': 'Rotavirus vaccination'}, {'cui': 'C0019693', 'cui_str': 'Human immunodeficiency virus infection'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0037712', 'cui_str': 'South Africa'}, {'cui': 'C0027567', 'cui_str': 'African race'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0205145', 'cui_str': 'Site'}]","[{'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0030547', 'cui_str': 'Parenteral nutrition'}, {'cui': 'C0599220', 'cui_str': 'Protein Subunit'}, {'cui': 'C0597418', 'cui_str': 'Rotavirus vaccine'}, {'cui': 'C0021492', 'cui_str': 'Intramuscular injection'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0020835', 'cui_str': 'Immunoglobulin A'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0475463', 'cui_str': 'Neutralizing antibody'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0475208', 'cui_str': 'Titer'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0475270', 'cui_str': 'G2 grade'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",4.0,0.743237,"There were no significant differences in local or systemic adverse events, or unsolicited adverse events, between vaccine and placebo groups.","[{'ForeName': 'Michelle J', 'Initials': 'MJ', 'LastName': 'Groome', 'Affiliation': 'South African Medical Research Council (SAMRC): Respiratory and Meningeal Pathogens Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa; Department of Science and Technology/National Research Foundation (DST/NRF): Vaccine Preventable Diseases, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa. Electronic address: groomem@rmpru.co.za.'}, {'ForeName': 'Lee', 'Initials': 'L', 'LastName': 'Fairlie', 'Affiliation': 'Wits Reproductive Health and HIV Institute, School of Clinical Medicine, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Morrison', 'Affiliation': 'Family Clinical Research Unit, Department of Paediatrics and Child Health, Stellenbosch University, Stellenbosch, South Africa.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Fix', 'Affiliation': 'PATH, Washington, DC, USA.'}, {'ForeName': 'Anthonet', 'Initials': 'A', 'LastName': 'Koen', 'Affiliation': 'South African Medical Research Council (SAMRC): Respiratory and Meningeal Pathogens Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa; Department of Science and Technology/National Research Foundation (DST/NRF): Vaccine Preventable Diseases, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Maysseb', 'Initials': 'M', 'LastName': 'Masenya', 'Affiliation': 'Wits Reproductive Health and HIV Institute, School of Clinical Medicine, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Jose', 'Affiliation': 'South African Medical Research Council (SAMRC): Respiratory and Meningeal Pathogens Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa; Department of Science and Technology/National Research Foundation (DST/NRF): Vaccine Preventable Diseases, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Shabir A', 'Initials': 'SA', 'LastName': 'Madhi', 'Affiliation': 'South African Medical Research Council (SAMRC): Respiratory and Meningeal Pathogens Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa; Department of Science and Technology/National Research Foundation (DST/NRF): Vaccine Preventable Diseases, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Page', 'Affiliation': 'National Institute for Communicable Diseases, National Health Laboratory Service, Johannesburg, South Africa; Department of Medical Virology, Faculty of Health Sciences, University of Pretoria, Pretoria, South Africa.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'McNeal', 'Affiliation': ""Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, OH, USA; Division of Infectious Diseases, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.""}, {'ForeName': 'Len', 'Initials': 'L', 'LastName': 'Dally', 'Affiliation': 'The Emmes Corporation, Rockville, MD, USA.'}, {'ForeName': 'Iksung', 'Initials': 'I', 'LastName': 'Cho', 'Affiliation': 'PATH, Washington, DC, USA; Novavax, Gaithersburg, MD, USA.'}, {'ForeName': 'Maureen', 'Initials': 'M', 'LastName': 'Power', 'Affiliation': 'PATH, Washington, DC, USA.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Flores', 'Affiliation': 'PATH, Washington, DC, USA.'}, {'ForeName': 'Stanley', 'Initials': 'S', 'LastName': 'Cryz', 'Affiliation': 'PATH, Washington, DC, USA.'}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(20)30001-3'] 403,32252049,The Effect of Lactofem Oral Probiotic Capsule on Lactobacilli Colonization and Some Vaginal Health Parameters.,"BACKGROUND AND OBJECTIVE Healthy vaginal ecosystem is conserved with the connection of vaginal epithelium and flora in which lactobacilli play a significant role. The present study aimed to examine the effect of lactofem oral probiotic capsule on Lactobacillus colonization and some other vaginal health indices in women aged 18-55 years. MATERIALS AND METHODS This interventional, double-blind controlled clinical trial was conducted on 70 women with Nugent score = 4-6 and vaginal pH >4.5. The participants were divided into an oral probiotic group and a control group. The oral probiotic group was required to take one 500 mg lactofem capsule daily for 2 months, while placebo was prescribed for the control group. Samples from 6 visits were examined during the period of prescription. The data were analyzed using the SPSS statistical software, version 18. RESULTS The results showed no significant difference in the average colonization of vaginal Lactobacillus in the 2 groups before and during the intervention (p = 0.26). Also, no significant difference was observed in the 2 groups' Nugent mean scores before and after the intervention up to the 60th day. However, a statistically significant difference was found in this regard on the 70th day (p = 0.032). Moreover, the results indicated no significant difference in the 2 groups' mean vaginal pH before and after the intervention (p = 0.101). CONCLUSION Lactofem oral capsule could improve the participants' Nugent scores, but caused no change in Lactobacillus colonization or vaginal pH.",2020,"However, a statistically significant difference was found in this regard on the 70th day (p = 0.032).","['70 women with Nugent score\xa0= 4-6 and vaginal pH >4.5', 'women aged 18-55 years']","['lactofem oral probiotic capsule', 'Lactofem Oral Probiotic Capsule', 'placebo']","['vaginal health indices', 'average colonization of vaginal Lactobacillus', 'mean vaginal pH', 'Lactobacilli Colonization and Some Vaginal Health Parameters', 'Lactobacillus colonization or vaginal pH']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0429263', 'cui_str': 'Vaginal pH'}, {'cui': 'C3844009', 'cui_str': '4.5'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0022938', 'cui_str': 'Lactobacillus'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0429263', 'cui_str': 'Vaginal pH'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",70.0,0.0317616,"However, a statistically significant difference was found in this regard on the 70th day (p = 0.032).","[{'ForeName': 'Zohreh', 'Initials': 'Z', 'LastName': 'Balaghi', 'Affiliation': 'Student Research Committee, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Azima', 'Affiliation': 'Department of Midwifery, School of Nursing and Midwifery, Shiraz University of Medical Sciences, Shiraz, Iran, azimas@sums.ac.ir.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Motamedifar', 'Affiliation': 'Department of Bacteriology and Virology, School of Medicine, and HIV/AIDS Research Center (SHARC), Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Maasumeh', 'Initials': 'M', 'LastName': 'Kaviani', 'Affiliation': 'Department of Midwifery, School of Nursing and Midwifery, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Tahereh', 'Initials': 'T', 'LastName': 'Poordast', 'Affiliation': 'Department of Obstetrics and Gynecology, School of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Najaf', 'Initials': 'N', 'LastName': 'Zare', 'Affiliation': 'Department of Biostatistics, Infertility Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}]",Gynecologic and obstetric investigation,['10.1159/000506802'] 404,32149863,Learning mechanisms in nocebo hyperalgesia: the role of conditioning and extinction processes.,"Nocebo hyperalgesia is a clinically relevant phenomenon and may be formed as a result of associative learning, implemented by classical conditioning. This study explored for the first time distinct nocebo conditioning methods and their consequences for nocebo attenuation methods. Healthy participants (N = 140) were recruited and randomized to the following nocebo hyperalgesia induction groups: conditioning with continuous reinforcement (CRF), conditioning with partial reinforcement (PRF), and a sham-conditioning control group. In the attenuation phase, counterconditioning was compared with extinction. During induction, participants experienced increased thermal pain in 100% of nocebo trials in the CRF groups, while in only 70% of nocebo trials in the PRF groups. During evocation, pain stimulation was equivalent across all trials. During attenuation, pain stimulation was decreased on nocebo trials relative to control trials for the counterconditioning groups, while pain remained equivalent across all trials for the extinction groups. Results showed that both PRF and CRF significantly induced nocebo hyperalgesia, but CRF was a more potent nocebo induction method, as compared to PRF. Counterconditioning was more effective than extinction in attenuating nocebo hyperalgesia. Neither CRF nor PRF resulted in resistance to extinction. However, compared with CRF, conditioning with PRF resulted in more resistance to counterconditioning. These findings demonstrate that the more ambiguous learning method of PRF can induce nocebo hyperalgesia and may potentially explain the treatment resistance and chronification seen in clinical practice. Further research is required to establish whether attenuation with counterconditioning is generalizable to clinical settings.",2020,"During attenuation, pain stimulation was decreased on nocebo trials relative to control trials for the counterconditioning groups, while pain remained equivalent across all trials for the extinction groups.","['Healthy participants (N = 140', 'nocebo hyperalgesia']","['nocebo hyperalgesia induction groups: conditioning with continuous reinforcement (CRF), conditioning with partial reinforcement (PRF), and a sham-conditioning control group', 'PRF and CRF']","['nocebo hyperalgesia', 'pain stimulation', 'thermal pain']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C3658218', 'cui_str': 'Nocebo'}, {'cui': 'C0020429', 'cui_str': 'Hyperalgesic Sensations'}]","[{'cui': 'C3658218', 'cui_str': 'Nocebo'}, {'cui': 'C0020429', 'cui_str': 'Hyperalgesic Sensations'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0035007', 'cui_str': 'Reinforcement'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0033374', 'cui_str': 'Prolactin-Releasing Peptide'}, {'cui': 'C0010132', 'cui_str': 'corticorelin'}]","[{'cui': 'C3658218', 'cui_str': 'Nocebo'}, {'cui': 'C0020429', 'cui_str': 'Hyperalgesic Sensations'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}]",140.0,0.0465884,"During attenuation, pain stimulation was decreased on nocebo trials relative to control trials for the counterconditioning groups, while pain remained equivalent across all trials for the extinction groups.","[{'ForeName': 'Mia Athina', 'Initials': 'MA', 'LastName': 'Thomaidou', 'Affiliation': 'Health, Medical and Neuropsychology Unit, Leiden University, Leiden, the Netherlands.'}, {'ForeName': 'Dieuwke Swaantje', 'Initials': 'DS', 'LastName': 'Veldhuijzen', 'Affiliation': 'Health, Medical and Neuropsychology Unit, Leiden University, Leiden, the Netherlands.'}, {'ForeName': 'Kaya Joanne', 'Initials': 'KJ', 'LastName': 'Peerdeman', 'Affiliation': 'Health, Medical and Neuropsychology Unit, Leiden University, Leiden, the Netherlands.'}, {'ForeName': 'Naomi Zoë Sifra', 'Initials': 'NZS', 'LastName': 'Wiebing', 'Affiliation': 'Health, Medical and Neuropsychology Unit, Leiden University, Leiden, the Netherlands.'}, {'ForeName': 'Joseph Sullivan', 'Initials': 'JS', 'LastName': 'Blythe', 'Affiliation': 'Health, Medical and Neuropsychology Unit, Leiden University, Leiden, the Netherlands.'}, {'ForeName': 'Andrea Walbruga Maria', 'Initials': 'AWM', 'LastName': 'Evers', 'Affiliation': 'Health, Medical and Neuropsychology Unit, Leiden University, Leiden, the Netherlands.'}]",Pain,['10.1097/j.pain.0000000000001861'] 405,30617704,Reliability and between-group stability of a health-related quality of life symptom index for persons with anal high-grade squamous intraepithelial lesions: an AIDS Malignancy Consortium Study (AMC-A03).,"PURPOSE The Anal Cancer HSIL Outcomes Research (ANCHOR) trial aims to determine whether treating precancerous anal high-grade squamous intraepithelial lesions (HSIL), versus active surveillance, is effective in reducing anal cancer incidence in HIV-infected individuals. We evaluated the reliability (i.e., internal consistency, test-retest) and between-group stability of a 25-item ANCHOR Health-Related Symptom Index (A-HRSI). METHODS ANCHOR participants at least 1-month post-randomization to treatment or active surveillance completed the A-HRSI via telephone. Participants were contacted 7-10 days later to complete the A-HRSI and a participant global impression of change (PGIC) item. RESULTS Participants (n = 100) were enrolled (mean age = 51.4, 79% cisgender-male, 73% African American, 9% Hispanic) from five ANCHOR sites. Cronbach's α was good for the physical symptoms (0.82) domain and fair for the physical impacts (0.79) and psychological symptoms (0.73) domains. Intraclass correlation coefficients were good for each of respective domains (i.e., 0.80, 0.85, and 0.82). There were no significant differences in PGIC between the treatment (n = 56) and active surveillance (n = 44) groups (F(1,98) = 2.03, p = 0.16). CONCLUSIONS The A-HRSI is able to reliably assess participant-reported symptoms and impacts of anal HSIL across a 7-10 days of timeframe. Future work will involve the establishment of construct and discriminant validity prior to inclusion in the full ANCHOR trial.",2019,"There were no significant differences in PGIC between the treatment (n = 56) and active surveillance (n = 44) groups (F(1,98) = 2.03, p = 0.16). ","['persons with anal high-grade squamous intraepithelial lesions', 'HIV-infected individuals', 'Participants (n\u2009=\u2009100) were enrolled (mean age\u2009=\u200951.4, 79% cisgender-male, 73% African American, 9% Hispanic) from five ANCHOR sites', 'ANCHOR participants at least 1-month post-randomization to treatment or active surveillance completed the A-HRSI via telephone', 'precancerous anal high-grade squamous intraepithelial lesions (HSIL']",[],"['psychological symptoms', '25-item ANCHOR Health-Related Symptom Index (A-HRSI', 'anal cancer incidence', 'health-related quality of life symptom index', 'PGIC']","[{'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C1735618', 'cui_str': 'Anal high grade squamous intraepithelial lesion'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C1293132', 'cui_str': 'Anchoring'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1827061', 'cui_str': 'Active surveillance'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0333875', 'cui_str': 'HSIL, High-Grade Squamous Intraepithelial Lesions'}]",[],"[{'cui': 'C0233397', 'cui_str': 'Psychological symptom'}, {'cui': 'C1293132', 'cui_str': 'Anchoring'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0279637', 'cui_str': 'Anal Cancer'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0034380'}]",100.0,0.0625723,"There were no significant differences in PGIC between the treatment (n = 56) and active surveillance (n = 44) groups (F(1,98) = 2.03, p = 0.16). ","[{'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Atkinson', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY, USA. atkinsot@mskcc.org.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Palefsky', 'Affiliation': 'University of California-San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Yuelin', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Webb', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'J Michael', 'Initials': 'JM', 'LastName': 'Berry', 'Affiliation': 'University of California-San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Goldstone', 'Affiliation': 'Laser Surgery Care, New York, NY, USA.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Levine', 'Affiliation': 'Montefiore Medical Center, New York, NY, USA.'}, {'ForeName': 'Timothy J', 'Initials': 'TJ', 'LastName': 'Wilkin', 'Affiliation': 'Weill Cornell Medicine, New York, NY, USA.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Bucher', 'Affiliation': 'Anal Dysplasia Clinic Midwest, Chicago, IL, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Cella', 'Affiliation': 'Northwestern University Feinberg School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Jack E', 'Initials': 'JE', 'LastName': 'Burkhalter', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation",['10.1007/s11136-018-2089-8'] 406,31483448,Patterns of Recurrence After Resection of Pancreatic Ductal Adenocarcinoma: A Secondary Analysis of the ESPAC-4 Randomized Adjuvant Chemotherapy Trial.,"Importance The patterns of disease recurrence after resection of pancreatic ductal adenocarcinoma with adjuvant chemotherapy remain unclear. Objective To define patterns of recurrence after adjuvant chemotherapy and the association with survival. Design, Setting, and Participants Prospectively collected data from the phase 3 European Study Group for Pancreatic Cancer 4 adjuvant clinical trial, an international multicenter study. The study included 730 patients who had resection and adjuvant chemotherapy for pancreatic cancer. Data were analyzed between July 2017 and May 2019. Interventions Randomization to adjuvant gemcitabine or gemcitabine plus capecitabine. Main Outcomes and Measures Overall survival, recurrence, and sites of recurrence. Results Of the 730 patients, median age was 65 years (range 37-81 years), 414 were men (57%), and 316 were women (43%). The median follow-up time from randomization was 43.2 months (95% CI, 39.7-45.5 months), with overall survival from time of surgery of 27.9 months (95% CI, 24.8-29.9 months) with gemcitabine and 30.2 months (95% CI, 25.8-33.5 months) with the combination (HR, 0.81; 95% CI, 0.68-0.98; P = .03). The 5-year survival estimates were 17.1% (95% CI, 11.6%-23.5%) and 28.0% (22.0%-34.3%), respectively. Recurrence occurred in 479 patients (65.6%); another 78 patients (10.7%) died without recurrence. Local recurrence occurred at a median of 11.63 months (95% CI, 10.05-12.19 months), significantly different from those with distant recurrence with a median of 9.49 months (95% CI, 8.44-10.71 months) (HR, 1.21; 95% CI, 1.01-1.45; P = .04). Following recurrence, the median survival was 9.36 months (95% CI, 8.08-10.48 months) for local recurrence and 8.94 months (95% CI, 7.82-11.17 months) with distant recurrence (HR, 0.89; 95% CI, 0.73-1.09; P = .27). The median overall survival of patients with distant-only recurrence (23.03 months; 95% CI, 19.55-25.85 months) or local with distant recurrence (23.82 months; 95% CI, 17.48-28.32 months) was not significantly different from those with only local recurrence (24.83 months; 95% CI, 22.96-27.63 months) (P = .85 and P = .35, respectively). Gemcitabine plus capecitabine had a 21% reduction of death following recurrence compared with monotherapy (HR, 0.79; 95% CI, 0.64-0.98; P = .03). Conclusions and Relevance There were no significant differences between the time to recurrence and subsequent and overall survival between local and distant recurrence. Pancreatic cancer behaves as a systemic disease requiring effective systemic therapy after resection. Trial Registration ClinicalTrials.gov identifier: NCT00058201, EudraCT 2007-004299-38, and ISRCTN 96397434.",2019,"Conclusions and Relevance There were no significant differences between the time to recurrence and subsequent and overall survival between local and distant recurrence.","[' median age was 65 years (range 37-81 years), 414 were men (57%), and 316 were women (43', '730 patients who had resection and adjuvant chemotherapy for pancreatic cancer', 'Pancreatic Ductal Adenocarcinoma', '730 patients']","['Gemcitabine plus capecitabine', 'gemcitabine', 'gemcitabine or gemcitabine plus capecitabine']","['local recurrence', 'median overall survival', 'Measures\n\n\nOverall survival, recurrence, and sites of recurrence', 'overall survival', 'median survival', 'death following recurrence', 'local with distant recurrence', 'time to recurrence and subsequent and overall survival', 'Recurrence', 'distant recurrence', 'median follow-up time', 'Local recurrence', '5-year survival estimates']","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C4517771', 'cui_str': 'Four hundred and fourteen'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0450356', 'cui_str': '316'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0346647', 'cui_str': 'Cancer of Pancreas'}, {'cui': 'C0001418', 'cui_str': 'Adenoma, Malignant'}]","[{'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}]","[{'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C2945843', 'cui_str': 'Site of (attribute)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0443203', 'cui_str': 'Distant (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}]",730.0,0.440122,"Conclusions and Relevance There were no significant differences between the time to recurrence and subsequent and overall survival between local and distant recurrence.","[{'ForeName': 'Robert P', 'Initials': 'RP', 'LastName': 'Jones', 'Affiliation': 'The Royal Liverpool University Hospital, Liverpool, England.'}, {'ForeName': 'Eftychia-Eirini', 'Initials': 'EE', 'LastName': 'Psarelli', 'Affiliation': 'University of Liverpool, Liverpool, England.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Jackson', 'Affiliation': 'University of Liverpool, Liverpool, England.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Ghaneh', 'Affiliation': 'The Royal Liverpool University Hospital, Liverpool, England.'}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': 'Halloran', 'Affiliation': 'The Royal Liverpool University Hospital, Liverpool, England.'}, {'ForeName': 'Daniel H', 'Initials': 'DH', 'LastName': 'Palmer', 'Affiliation': 'University of Liverpool, Liverpool, England.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Campbell', 'Affiliation': 'The Royal Liverpool University Hospital, Liverpool, England.'}, {'ForeName': 'Juan W', 'Initials': 'JW', 'LastName': 'Valle', 'Affiliation': 'University of Manchester/The Christie, Manchester, England.'}, {'ForeName': 'Olusola', 'Initials': 'O', 'LastName': 'Faluyi', 'Affiliation': 'The Clatterbridge Cancer Centre, Wirral, England.'}, {'ForeName': 'Derek A', 'Initials': 'DA', 'LastName': ""O'Reilly"", 'Affiliation': 'Manchester University Foundation Trust, Manchester, England.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Cunningham', 'Affiliation': 'Royal Marsden Hospital, London, England.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Wadsley', 'Affiliation': 'Weston Park Hospital, Sheffield, England.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Darby', 'Affiliation': 'Weston Park Hospital, Sheffield, England.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Meyer', 'Affiliation': 'Royal Free Hospital, London, England.'}, {'ForeName': 'Roopinder', 'Initials': 'R', 'LastName': 'Gillmore', 'Affiliation': 'Royal Free Hospital, London, England.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Anthoney', 'Affiliation': ""St. James's University Hospital, Leeds, England.""}, {'ForeName': 'Pehr', 'Initials': 'P', 'LastName': 'Lind', 'Affiliation': 'Clinical Research Sörmland, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Bengt', 'Initials': 'B', 'LastName': 'Glimelius', 'Affiliation': 'Clinical Research Sörmland, University of Uppsala, Uppsala, Sweden.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Falk', 'Affiliation': 'Bristol Haematology and Oncology Centre, Bristol, England.'}, {'ForeName': 'Jakob R', 'Initials': 'JR', 'LastName': 'Izbicki', 'Affiliation': 'University of Hamburg Medical Institutions UKE, Hamburg, Germany.'}, {'ForeName': 'Gary William', 'Initials': 'GW', 'LastName': 'Middleton', 'Affiliation': 'Royal Surrey County Hospital, Guildford, England.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Cummins', 'Affiliation': 'Royal Surrey County Hospital, Guildford, England.'}, {'ForeName': 'Paul J', 'Initials': 'PJ', 'LastName': 'Ross', 'Affiliation': ""Guy's Hospital, London, England.""}, {'ForeName': 'Harpreet', 'Initials': 'H', 'LastName': 'Wasan', 'Affiliation': 'Hammersmith Hospital, London, England.'}, {'ForeName': 'Alec', 'Initials': 'A', 'LastName': 'McDonald', 'Affiliation': 'The Beatson West of Scotland Cancer Centre, Glasgow, Scotland.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Crosby', 'Affiliation': 'Velindre Hospital, Cardiff, Wales.'}, {'ForeName': 'Yuk', 'Initials': 'Y', 'LastName': 'Ting', 'Affiliation': 'Queen Elizabeth Hospital, Birmingham, England.'}, {'ForeName': 'Kinnari', 'Initials': 'K', 'LastName': 'Patel', 'Affiliation': 'Churchill Hospital, Oxford, England.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Sherriff', 'Affiliation': 'Derriford Hospital, Plymouth, England.'}, {'ForeName': 'Rubin', 'Initials': 'R', 'LastName': 'Soomal', 'Affiliation': 'Jersey General Hospital, Jersey, England.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Borg', 'Affiliation': 'Skåne University Hospital, Lund, Sweden.'}, {'ForeName': 'Sharmila', 'Initials': 'S', 'LastName': 'Sothi', 'Affiliation': 'University Hospital Coventry, Coventry, England.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Hammel', 'Affiliation': 'Hôpital Beaujon, Clichy, France.'}, {'ForeName': 'Markus M', 'Initials': 'MM', 'LastName': 'Lerch', 'Affiliation': 'Greifswald University, Medicine, Greifswald, Germany.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Mayerle', 'Affiliation': 'Greifswald University, Medicine, Greifswald, Germany.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Tjaden', 'Affiliation': 'University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Strobel', 'Affiliation': 'University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Thilo', 'Initials': 'T', 'LastName': 'Hackert', 'Affiliation': 'University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Markus W', 'Initials': 'MW', 'LastName': 'Büchler', 'Affiliation': 'University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Neoptolemos', 'Affiliation': 'University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA surgery,['10.1001/jamasurg.2019.3337'] 407,31277077,Cardiorespiratory behavior of preterm infants receiving continuous positive airway pressure and high flow nasal cannula post extubation: randomized crossover study.,"BACKGROUND Nasal continuous positive airway pressure (NCPAP) and high flow nasal cannula (HFNC) are modes of non-invasive respiratory support commonly used after extubation in extremely preterm infants. However, the cardiorespiratory physiology of these infants on each mode is unknown. METHODS Prospective, randomized crossover study in infants with birth weight ≤1250 g undergoing their first extubation attempt. NCPAP and HFNC were applied randomly for 45 min each, while ribcage and abdominal movements, electrocardiogram, oxygen saturation, and fraction of inspired oxygen (FiO 2 ) were recorded. Respiratory signals were analyzed using an automated method, and differences between NCPAP and HFNC features and changes in FiO 2 were analyzed. RESULTS A total of 30 infants with median [interquartile range] gestational age of 27 weeks [25.7, 27.9] and birth weight of 930 g [780, 1090] were studied. Infants were extubated at 5 days [2, 13] of life with 973 g [880, 1170] and three failed (10%). No differences in cardiorespiratory behavior were noted, except for longer respiratory pauses (9.2 s [5.0, 11.5] vs. 7.3 s [4.6, 9.3]; p = 0.04) and higher FiO 2 levels (p = 0.02) during HFNC compared to NCPAP. CONCLUSIONS In extremely preterm infants studied shortly after extubation, the use of HFNC was associated with longer respiratory pauses and higher FiO 2 requirements.",2020,"No differences in cardiorespiratory behavior were noted, except for longer respiratory pauses (9.2 s [5.0, 11.5] vs. 7.3 s [4.6, 9.3]; p = 0.04) and higher FiO 2 levels (p = 0.02) during HFNC compared to NCPAP. ","['extremely preterm infants', 'infants with birth weight ≤1250', 'preterm infants receiving continuous positive airway pressure and high flow nasal cannula post extubation', '30 infants with median [interquartile range] gestational age of 27 weeks [25.7, 27.9] and birth weight of 930\u2009g [780, 1090']","['HFNC', 'NCPAP and HFNC', 'Nasal continuous positive airway pressure (NCPAP) and high flow nasal cannula (HFNC']","['longer respiratory pauses', 'ribcage and abdominal movements, electrocardiogram, oxygen saturation, and fraction of inspired oxygen (FiO 2 ', 'cardiorespiratory behavior']","[{'cui': 'C3494262', 'cui_str': 'Extremely Preterm Infants'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0005612', 'cui_str': 'Birth Weight'}, {'cui': 'C4048294', 'cui_str': 'Preterm Infant'}, {'cui': 'C0199451', 'cui_str': 'Continuous Positive Airway Pressure'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0179574', 'cui_str': 'Nasal Cannula'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0553891', 'cui_str': 'Tracheal Extubation'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0017504', 'cui_str': 'Fetal Maturity, Chronologic'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C1258045', 'cui_str': 'Nasal Continuous Positive Airway Pressure'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0179574', 'cui_str': 'Nasal Cannula'}]","[{'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0222762', 'cui_str': 'Thoracic Cage'}, {'cui': 'C1286159', 'cui_str': 'Movement of abdomen'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0523807', 'cui_str': 'Oximetry'}, {'cui': 'C0428167', 'cui_str': 'FIO2'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}]",30.0,0.118465,"No differences in cardiorespiratory behavior were noted, except for longer respiratory pauses (9.2 s [5.0, 11.5] vs. 7.3 s [4.6, 9.3]; p = 0.04) and higher FiO 2 levels (p = 0.02) during HFNC compared to NCPAP. ","[{'ForeName': 'Lara J', 'Initials': 'LJ', 'LastName': 'Kanbar', 'Affiliation': 'Department of Biomedical Engineering, Montreal, QC, Canada.'}, {'ForeName': 'Wissam', 'Initials': 'W', 'LastName': 'Shalish', 'Affiliation': 'Department of Pediatrics, Neonatal Division, Montreal, QC, Canada.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Latremouille', 'Affiliation': 'Department of Pediatrics, Neonatal Division, Montreal, QC, Canada.'}, {'ForeName': 'Smita', 'Initials': 'S', 'LastName': 'Rao', 'Affiliation': 'Department of Pediatrics, Neonatal Division, Montreal, QC, Canada.'}, {'ForeName': 'Karen A', 'Initials': 'KA', 'LastName': 'Brown', 'Affiliation': 'Department of Anesthesia, McGill University, Montreal, QC, Canada.'}, {'ForeName': 'Robert E', 'Initials': 'RE', 'LastName': 'Kearney', 'Affiliation': 'Department of Biomedical Engineering, Montreal, QC, Canada.'}, {'ForeName': 'Guilherme M', 'Initials': 'GM', 'LastName': ""Sant'Anna"", 'Affiliation': 'Department of Pediatrics, Neonatal Division, Montreal, QC, Canada. guilherme.santanna@mcgill.ca.'}]",Pediatric research,['10.1038/s41390-019-0494-5'] 408,30959274,Coping with stress: A pilot study of a self-help stress management intervention for patients with epileptic or psychogenic nonepileptic seizures.,"PURPOSE Many patients with epilepsy or psychogenic nonepileptic seizures (PNES) experience high levels of stress. Although psychological interventions have been developed for seizure disorders, few patients can currently access them. We aimed to assess the acceptability and feasibility of a self-help intervention targeting stress in patients with seizures, and to provide preliminary evidence for its effectiveness. METHOD Patients were recruited from outpatient neurology clinics and randomized to an immediate intervention group (n = 39), who received the intervention at baseline, or a delayed intervention group (n = 43), who received the intervention one-month postbaseline. Participants completed self-report questionnaires measuring stress (Smith Stress Symptom Inventory [SSSI]), anxiety (Generalized Anxiety Disorder 7-item Scale [GAD-7]), depression (Neurological Disorders Depression Inventory for Epilepsy [NDDI-E]), quality of life (European Quality of Life - 5 Dimensions [EQ-5D]), and seizure severity and frequency (Liverpool Seizure Severity Scale [LSSS-3]) at baseline, and at one- and two-month follow-up. Participants also provided telephone feedback. The intervention consisted of a self-help stress management workbook based on an integrative stress model framework. RESULTS Although the rate of participants failing to return follow-up information at two months was approximately 50%, those who completed the trial found the intervention acceptable; with the majority rating it as helpful (63.6%) and that they would recommend it to others with seizures (88.1%). A significant reduction in self-reported stress (P = .01) with a medium effect size (d z  = 0.51) was observed one-month postintervention. There were no significant changes in any other measures. CONCLUSION The intervention was perceived to be acceptable, safe, and helpful by participants. It could be a useful complementary treatment option for reducing stress experienced by patients living with seizure disorders. Further evaluation in a larger trial is warranted.",2019,A significant reduction in self-reported stress (P = .01) with a medium effect size (d z  = 0.51) was observed one-month postintervention.,"['Patients were recruited from outpatient neurology clinics and randomized to an', 'patients with epileptic or psychogenic nonepileptic seizures', 'patients living with seizure disorders', 'patients with seizures', 'patients with epilepsy or psychogenic nonepileptic seizures (PNES) experience high levels of stress']","['self-help stress management intervention', 'self-help intervention', 'self-help stress management workbook based on an integrative stress model framework', 'immediate intervention group (n\u202f=\u202f39), who received the intervention at baseline, or a delayed intervention group (n\u202f=\u202f43), who received the intervention one-month postbaseline']","['self-report questionnaires measuring stress (Smith Stress Symptom Inventory [SSSI]), anxiety (Generalized Anxiety Disorder 7-item Scale [GAD-7]), depression (Neurological Disorders Depression Inventory for Epilepsy [NDDI-E]), quality of life (European Quality of Life - 5 Dimensions [EQ-5D]), and seizure severity and frequency (Liverpool Seizure Severity Scale [LSSS-3']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C3814532', 'cui_str': 'Neurology clinic (environment)'}, {'cui': 'C0014544', 'cui_str': 'Seizure Disorder'}, {'cui': 'C0458006', 'cui_str': 'Psychogenic (qualifier value)'}, {'cui': 'C3495874', 'cui_str': 'Nonepileptic Seizures'}, {'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C1319127', 'cui_str': 'Level of stress'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0150788', 'cui_str': 'Manage stress control'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4082115', 'cui_str': 'One month (qualifier value)'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0554249', 'cui_str': 'Smith (occupation)'}, {'cui': 'C0521991', 'cui_str': 'Symptoms of stress (finding)'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0003469', 'cui_str': 'Anxiety Disorders'}, {'cui': 'C0222045'}, {'cui': 'C3641330', 'cui_str': 'GAD-7'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0027765', 'cui_str': 'Neurologic Disorders'}, {'cui': 'C0014544', 'cui_str': 'Seizure Disorder'}, {'cui': 'C0034380'}, {'cui': 'C0239307', 'cui_str': 'European (ethnic group)'}, {'cui': 'C0439534', 'cui_str': 'Dimensions (qualifier value)'}, {'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}]",,0.0327759,A significant reduction in self-reported stress (P = .01) with a medium effect size (d z  = 0.51) was observed one-month postintervention.,"[{'ForeName': 'Barbora', 'Initials': 'B', 'LastName': 'Novakova', 'Affiliation': 'Academic Neurology Unit, University of Sheffield, Royal Hallamshire Hospital, Glossop Road, Sheffield S10 2JF, UK. Electronic address: barbora.novakova@nhs.net.'}, {'ForeName': 'Peter R', 'Initials': 'PR', 'LastName': 'Harris', 'Affiliation': 'School of Psychology, University of Sussex, Falmer, Brighton BN1 9QH, UK.'}, {'ForeName': 'Gregg H', 'Initials': 'GH', 'LastName': 'Rawlings', 'Affiliation': 'Clinical Psychology Unit, University of Sheffield, Cathedral Court, 1 Vicar Lane, Sheffield S1 2LT, UK.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Reuber', 'Affiliation': 'Academic Neurology Unit, University of Sheffield, Royal Hallamshire Hospital, Glossop Road, Sheffield S10 2JF, UK.'}]",Epilepsy & behavior : E&B,['10.1016/j.yebeh.2019.03.002'] 409,31322552,Anesthesia of the conditioned limb does not abolish the remote ischemic conditioning stimulus on cutaneous microcirculation in humans.,"BACKGROUND Mechanism of remote ischemic conditioning (RIC) remain not fully understood yet. Thus, a clinical trial was performed to assess the neuronal influence on its signal induction. METHODS RIC was conducted on 45 patients who were randomized into 3 groups. Group A and B underwent brachial plexus anesthesia while RIC was performed on the blocked (A) and non-blocked side (B), respectively. In group C, RIC was conducted before regional anesthesia, thus serving as control group. All measurements were taken contralateral to RIC. The relative increase of microcirculatory parameters compared to baseline was evaluated and compared between the groups. RESULTS Superficial blood flow (sBF) significantly increased in group A and C but values were higher among group C. Compared to group A, group C showed a significant increase of sBF during the initial 5 minutes of reperfusion (1.75; CI 1.139 - 2.361 vs. 0.97, CI 0.864 - 1.076, p < 0.05). Deep blood flow, tissue oxygen saturation and relative hemoglobin content were marginally influenced by RIC irrespectively of the presence of regional anesthesia. CONCLUSION Despite regional anesthesia a significant RIC stimulus can be induced although its microcirculatory response is attenuated compared to control. Hence, RIC induction does not merely depend on neuronal signaling.",2020,"Deep blood flow, tissue oxygen saturation and relative hemoglobin content were marginally influenced by RIC irrespectively of the presence of regional anesthesia. ","['45 patients who were randomized into 3 groups', 'cutaneous microcirculation in humans']",['brachial plexus anesthesia while RIC'],"['Deep blood flow, tissue oxygen saturation and relative hemoglobin content', 'sBF', 'microcirculatory parameters', 'Superficial blood flow (sBF']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4521174', 'cui_str': 'Cutaneous'}, {'cui': 'C0025962', 'cui_str': 'Microcirculation'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C0394697', 'cui_str': 'Brachial Plexus Anesthesia'}]","[{'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow, function (observable entity)'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C0523807', 'cui_str': 'Oximetry'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0205124', 'cui_str': 'Superficial (qualifier value)'}]",,0.0149768,"Deep blood flow, tissue oxygen saturation and relative hemoglobin content were marginally influenced by RIC irrespectively of the presence of regional anesthesia. ","[{'ForeName': 'I A', 'Initials': 'IA', 'LastName': 'Ederer', 'Affiliation': 'Department of Hand, Plastic and Reconstructive Surgery, BG Unfallklinik Tuebingen, Eberhard Karls University Tuebingen, Tuebingen, Germany.'}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Goertz', 'Affiliation': 'Department of Plastic Surgery, Burn Center, BG University Hospital Bergmannsheil, Ruhr-University Bochum, Bochum, Germany.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Bosselmann', 'Affiliation': 'Centre of Plastic, Aesthetic, Hand and Reconstructive Surgery, University of Regensburg, Regensburg, Germany.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Sogorski', 'Affiliation': 'Department of Plastic Surgery, Burn Center, BG University Hospital Bergmannsheil, Ruhr-University Bochum, Bochum, Germany.'}, {'ForeName': 'P K', 'Initials': 'PK', 'LastName': 'Zahn', 'Affiliation': 'Department of Anesthesiology and Intensive Care Medicine, BG University Hospital Bergmannsheil, Ruhr-University Bochum, Bochum, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Lehnhardt', 'Affiliation': 'Department of Plastic Surgery, Burn Center, BG University Hospital Bergmannsheil, Ruhr-University Bochum, Bochum, Germany.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Daigeler', 'Affiliation': 'Department of Hand, Plastic and Reconstructive Surgery, BG Unfallklinik Tuebingen, Eberhard Karls University Tuebingen, Tuebingen, Germany.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Kolbenschlag', 'Affiliation': 'Department of Hand, Plastic and Reconstructive Surgery, BG Unfallklinik Tuebingen, Eberhard Karls University Tuebingen, Tuebingen, Germany.'}]",Clinical hemorheology and microcirculation,['10.3233/CH-190626'] 410,30939410,Comparative neuropsychological effects of carbamazepine and eslicarbazepine acetate.,"People with epilepsy are at increased risk for neuropsychological dysfunction due to multiple factors, of which the most amendable are antiseizure medications (ASMs). Antiseizure medication effectiveness is frequently determined by tolerability. In this study, we compared the neuropsychological effects of eslicarbazepine acetate (ESL) and carbamazepine immediate-release (CBZ) using a randomized, double-blind, crossover design in healthy volunteers with a 2-week titration and 4-week maintenance phase in each treatment arm (CBZ = 400 mg BID and ESL = 800 mg qAM). Neuropsychological testing was performed at the initial visit, repeated at 1st baseline nondrug condition, end treatment #1, 2nd nondrug condition one month after treatment #1, end treatment #2, and 3rd nondrug condition one month after treatment #2. Neuropsychological testing was conducted 2 h after morning dose and included computer (i.e., dual task test, selective attention test, symbol digit, verbal memory, visuospatial memory, and 1- & 2-back continuous performance) and noncomputer tasks (i.e., Medical College of Georgia (MCG) paragraph memory, Stroop, Symbol Digit Modalities Test, Profile of Mood States). z-Scores calculated from nondrug conditions were used to compare ESL and CBZ for the 23 completers. Follow-up analyses included individual test scores and distribution of individual raw means. Mean blood levels on test day were CBZ = 8.9 μg/ml and ESL = 15.3 μg/ml. Omnibus z-score was significantly better for ESL (p = .0001). For individual measures, executive function and selective attention tests were statistically significantly better for ESL. Individual test raw means favored ESL over CBZ on 22 of 30 measures (p = .016, 2-tailed sign test). Eslicarbazepine acetate demonstrated less adverse neuropsychological effects than CBZ.",2019,"Individual test raw means favored ESL over CBZ on 22 of 30 measures (p = .016, 2-tailed sign test).",['healthy volunteers with a 2-week titration and 4-week maintenance phase in each treatment arm '],"['CBZ', 'CBZ\u202f=\u202f400\u202fmg BID and ESL\u202f=\u202f800\u202fmg qAM', 'eslicarbazepine acetate (ESL) and carbamazepine immediate-release (CBZ', 'Eslicarbazepine acetate', 'carbamazepine and eslicarbazepine acetate']","['executive function and selective attention tests', 'adverse neuropsychological effects', 'Mean blood levels', 'dual task test, selective attention test, symbol digit, verbal memory, visuospatial memory, and 1- & 2-back continuous performance) and noncomputer tasks (i.e., Medical College of Georgia (MCG) paragraph memory, Stroop, Symbol Digit Modalities Test, Profile of Mood States', 'Antiseizure medication effectiveness']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}]","[{'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C0048106', 'cui_str': 'BIDS'}, {'cui': 'C3844106', 'cui_str': 'Eight hundred'}, {'cui': 'C2725262', 'cui_str': 'eslicarbazepine acetate'}, {'cui': 'C0006949', 'cui_str': 'Carbamazepine'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}]","[{'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0233421', 'cui_str': 'Selective inattention (finding)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0005768'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0582802', 'cui_str': 'Digit'}, {'cui': 'C0561770', 'cui_str': 'Verbal memory observable'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0017454', 'cui_str': 'Georgian S.S.R.'}, {'cui': 'C0451522', 'cui_str': 'Symbol Digit Modalities Test'}, {'cui': 'C0451394', 'cui_str': 'Profile of mood states (assessment scale)'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}]",,0.153677,"Individual test raw means favored ESL over CBZ on 22 of 30 measures (p = .016, 2-tailed sign test).","[{'ForeName': 'Kimford J', 'Initials': 'KJ', 'LastName': 'Meador', 'Affiliation': 'Department of Neurology and Neurological Sciences, Stanford University, Stanford, CA, USA. Electronic address: kmeador@stanford.edu.'}, {'ForeName': 'Jordan', 'Initials': 'J', 'LastName': 'Seliger', 'Affiliation': 'Department of Neurology and Neurological Sciences, Stanford University, Stanford, CA, USA. Electronic address: jseliger@stanford.edu.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Boyd', 'Affiliation': 'CNS Vital Signs, Morrisville, NC, USA. Electronic address: aboyd@cnsvs.com.'}, {'ForeName': 'Babak', 'Initials': 'B', 'LastName': 'Razavi', 'Affiliation': 'Department of Neurology and Neurological Sciences, Stanford University, Stanford, CA, USA. Electronic address: Brazavi@stanford.edu.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Falco-Walter', 'Affiliation': 'Department of Neurology and Neurological Sciences, Stanford University, Stanford, CA, USA. Electronic address: jessica.walter@stanford.edu.'}, {'ForeName': 'Scheherazade', 'Initials': 'S', 'LastName': 'Le', 'Affiliation': 'Department of Neurology and Neurological Sciences, Stanford University, Stanford, CA, USA. Electronic address: schele@stanford.edu.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Loring', 'Affiliation': 'Department of Neurology, Emory University, Atlanta, GA, USA. Electronic address: dloring@emory.edu.'}]",Epilepsy & behavior : E&B,['10.1016/j.yebeh.2019.02.034'] 411,30939411,Can behavioral strategies increase physical activity and influence depressive symptoms and quality of life among children with epilepsy? Results of a randomized controlled trial.,"PURPOSE This study examined whether increasing physical activity (PA) through 6 months of behavioral counseling positively influenced depressive symptoms and quality of life (QoL) over 12 months among children with epilepsy (CWE). METHODS A longitudinal multisite randomized controlled trial (RCT) was conducted with 8-14-year-old children with active epilepsy. Participants wore a pedometer to track daily PA and completed 3 measures at 4 time points to examine depressive symptoms and QoL. Stratified by site and activity level, participants were randomized to an intervention or control group. The 6-month intervention included 11 behavioral counseling sessions targeting self-regulation of PA. To assess the associations among PA, depression scores, and QoL, primary analysis involved mixed-effects models. RESULTS We recruited 122 CWE, of whom 115 were randomized (M age  = 11 ± 2; 50% female) and included in the analysis. The intervention did not increase PA in the treatment compared with the control group. No differences were found between groups over time during the subsequent 6 months, where PA decreased among all participants. Results did not show differences between the groups and over time for measures of depressive symptoms and QoL. SIGNIFICANCE The intervention did not improve or sustain PA levels over 12 months. Both groups demonstrated declines in PA over one year, but there were no changes in depression scores or QoL. As most participants were already nearly reaching the Canadian average of step counts of children their age, with a baseline daily step count of over 9000, there may be a challenge for further increasing PA over a longer period.",2019,"Results did not show differences between the groups and over time for measures of depressive symptoms and QoL. SIGNIFICANCE The intervention did not improve or sustain PA levels over 12 months.","['children with epilepsy', '8-14-year-old children with active epilepsy', 'We recruited 122 CWE, of whom 115 were randomized (M age \u202f=\u202f11\u202f±\u202f2; 50% female) and included in the analysis', 'children with epilepsy (CWE']",['behavioral counseling sessions targeting self-regulation of PA'],"['depressive symptoms and quality of life (QoL', 'PA', 'sustain PA levels', 'depressive symptoms and quality of life', 'depression scores or QoL']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0014544', 'cui_str': 'Seizure Disorder'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C1524024', 'cui_str': 'analysis'}]","[{'cui': 'C4546207', 'cui_str': 'Behavioral counseling (procedure)'}, {'cui': 'C0684274', 'cui_str': 'Self Regulation'}]","[{'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0034380'}, {'cui': 'C0443318', 'cui_str': 'Sustained (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.110137,"Results did not show differences between the groups and over time for measures of depressive symptoms and QoL. SIGNIFICANCE The intervention did not improve or sustain PA levels over 12 months.","[{'ForeName': 'Denver M Y', 'Initials': 'DMY', 'LastName': 'Brown', 'Affiliation': 'Department of Kinesiology, McMaster University, 1280 Main Street W, Hamilton, ON L8S 4L8, Canada. Electronic address: brownd32@mcmaster.ca.'}, {'ForeName': 'Nadilein', 'Initials': 'N', 'LastName': 'Mahlberg', 'Affiliation': 'Department of Pediatrics, McMaster University, 1400 Main Street W, Institute for Applied Health Sciences, Room 408, Hamilton, ON L8S 1C7, Canada. Electronic address: mahlbn@mcmaster.ca.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Pohl', 'Affiliation': ""Division of Neurology, Children's Hospital of Eastern Ontario, University of Ottawa, 401 Smyth Road, Ottawa, ON K1H 8L1, Canada. Electronic address: dpohl@cheo.on.ca.""}, {'ForeName': 'Brian W', 'Initials': 'BW', 'LastName': 'Timmons', 'Affiliation': 'Department of Pediatrics, McMaster University, 1400 Main Street W, Institute for Applied Health Sciences, Room 408, Hamilton, ON L8S 1C7, Canada. Electronic address: timmonsbw@mcmaster.ca.'}, {'ForeName': 'Steven R', 'Initials': 'SR', 'LastName': 'Bray', 'Affiliation': 'Department of Kinesiology, McMaster University, 1280 Main Street W, Hamilton, ON L8S 4L8, Canada. Electronic address: sbray@mcmaster.ca.'}, {'ForeName': 'David L', 'Initials': 'DL', 'LastName': 'Streiner', 'Affiliation': 'Department of Psychiatry and Behavioural Neurosciences, McMaster University, 100 West 5th Street, Hamilton, ON L9C 3N6, Canada; Department of Psychiatry, University of Toronto, 250 College Street, Toronto, ON M5T 1R8, Canada. Electronic address: streiner@mcmaster.ca.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Ferro', 'Affiliation': 'School of Public Health and Health Systems, University of Waterloo, 200 University Avenue W, Waterloo, ON N2L 3G1, Canada. Electronic address: mark.ferro@uwaterloo.ca.'}, {'ForeName': 'Sabrina', 'Initials': 'S', 'LastName': 'Hamer', 'Affiliation': ""Children's Hospital of Eastern Ontario Research Institute, 401 Smyth Road, Research Institute Building 2, Room R2109, Ottawa, ON K1H 8L1, Canada. Electronic address: shamer@cheo.on.ca.""}, {'ForeName': 'Peter L', 'Initials': 'PL', 'LastName': 'Rosenbaum', 'Affiliation': 'Department of Pediatrics, McMaster University, 1400 Main Street W, Institute for Applied Health Sciences, Room 408, Hamilton, ON L8S 1C7, Canada. Electronic address: rosenbau@mcmaster.ca.'}, {'ForeName': 'Gabriel M', 'Initials': 'GM', 'LastName': 'Ronen', 'Affiliation': 'Department of Pediatrics, McMaster University, 1400 Main Street W, Institute for Applied Health Sciences, Room 408, Hamilton, ON L8S 1C7, Canada. Electronic address: roneng@mcmaster.ca.'}]",Epilepsy & behavior : E&B,['10.1016/j.yebeh.2019.03.011'] 412,31505367,Blame-rebalance fMRI neurofeedback in major depressive disorder: A randomised proof-of-concept trial.,"Previously, using fMRI, we demonstrated lower connectivity between right anterior superior temporal (ATL) and anterior subgenual cingulate (SCC) regions while patients with major depressive disorder (MDD) experience guilt. This neural signature was detected despite symptomatic remission which suggested a putative role in vulnerability. This randomised controlled double-blind parallel group clinical trial investigated whether patients with MDD are able to voluntarily modulate this neural signature. To this end, we developed a fMRI neurofeedback software (FRIEND), which measures ATL-SCC coupling and displays its levels in real time. Twenty-eight patients with remitted MDD were randomised to two groups, each receiving one session of fMRI neurofeedback whilst retrieving guilt and indignation/anger-related autobiographical memories. They were instructed to feel the emotion whilst trying to increase the level of a thermometer-like display on a screen. Active intervention group: The thermometer levels increased with increasing levels of ATL-SCC correlations in the guilt condition. Control intervention group: The thermometer levels decreased when correlation levels deviated from the previous baseline level in the guilt condition, thus reinforcing stable correlations. Both groups also received feedback during the indignation condition reinforcing stable correlations. We confirmed our predictions that patients in the active intervention group were indeed able to increase levels of ATL-SCC correlations for guilt vs. indignation and their self-esteem after training compared to before training and that this differed significantly from the control intervention group. These data provide proof-of-concept for a novel treatment target for MDD patients and are in keeping with the hypothesis that ATL-SCC connectivity plays a key role in self-worth. https://clinicaltrials.gov/ct2/show/results/NCT01920490.",2019,This randomised controlled double-blind parallel group clinical trial investigated whether patients with MDD are able to voluntarily modulate this neural signature.,"['patients with major depressive disorder (MDD) experience guilt', 'major depressive disorder', 'patients with MDD', 'Twenty-eight patients with remitted MDD']","['fMRI neurofeedback whilst retrieving guilt and indignation/anger-related autobiographical memories', 'Control intervention']","['levels of ATL-SCC correlations', 'lower connectivity between right anterior superior temporal (ATL) and anterior subgenual cingulate (SCC) regions', 'levels of ATL-SCC correlations for guilt vs. indignation and their self-esteem']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C0018379', 'cui_str': 'Guilt'}, {'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0439600', 'cui_str': 'Remitting (qualifier value)'}]","[{'cui': 'C0376335', 'cui_str': 'fMRI'}, {'cui': 'C2713543', 'cui_str': 'Neurofeedback'}, {'cui': 'C0018379', 'cui_str': 'Guilt'}, {'cui': 'C0002957', 'cui_str': 'Anger'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0561843', 'cui_str': 'Autobiographical Memory'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0441997', 'cui_str': 'Right anterior (qualifier value)'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0442043', 'cui_str': 'Temporal (qualifier value)'}, {'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C0018427', 'cui_str': 'Cingulate Body'}, {'cui': 'C0018379', 'cui_str': 'Guilt'}, {'cui': 'C0036597', 'cui_str': 'Self Esteem'}]",28.0,0.0826356,This randomised controlled double-blind parallel group clinical trial investigated whether patients with MDD are able to voluntarily modulate this neural signature.,"[{'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Zahn', 'Affiliation': ""Centre for Affective Disorders, Institute of Psychiatry, Psychology & Neuroscience, King's College London, United Kingdom.""}, {'ForeName': 'Julie H', 'Initials': 'JH', 'LastName': 'Weingartner', 'Affiliation': ""Cognitive and Behavioral Neuroscience Unit, Neuroinformatics Workgroup, D'Or Institute for Research and Education (IDOR), Rio de Janeiro, Brazil.""}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Basilio', 'Affiliation': ""Cognitive and Behavioral Neuroscience Unit, Neuroinformatics Workgroup, D'Or Institute for Research and Education (IDOR), Rio de Janeiro, Brazil.""}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Bado', 'Affiliation': ""Cognitive and Behavioral Neuroscience Unit, Neuroinformatics Workgroup, D'Or Institute for Research and Education (IDOR), Rio de Janeiro, Brazil; Instituto de Ciências Biomédicas (ICB), Universidade Federal do Rio de Janeiro, Rio de Janeiro, Brazil.""}, {'ForeName': 'Paulo', 'Initials': 'P', 'LastName': 'Mattos', 'Affiliation': ""Cognitive and Behavioral Neuroscience Unit, Neuroinformatics Workgroup, D'Or Institute for Research and Education (IDOR), Rio de Janeiro, Brazil.""}, {'ForeName': 'João R', 'Initials': 'JR', 'LastName': 'Sato', 'Affiliation': ""Cognitive and Behavioral Neuroscience Unit, Neuroinformatics Workgroup, D'Or Institute for Research and Education (IDOR), Rio de Janeiro, Brazil; Center for Mathematics, Computation, and Cognition, Universidade Federal do ABC, Santo André, Brazil.""}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'de Oliveira-Souza', 'Affiliation': ""Cognitive and Behavioral Neuroscience Unit, Neuroinformatics Workgroup, D'Or Institute for Research and Education (IDOR), Rio de Janeiro, Brazil; Gaffrée e Guinle University Hospital, Federal University of the State of Rio de Janeiro, Rio de Janeiro, Brazil.""}, {'ForeName': 'Leo F', 'Initials': 'LF', 'LastName': 'Fontenelle', 'Affiliation': ""Cognitive and Behavioral Neuroscience Unit, Neuroinformatics Workgroup, D'Or Institute for Research and Education (IDOR), Rio de Janeiro, Brazil.""}, {'ForeName': 'Allan H', 'Initials': 'AH', 'LastName': 'Young', 'Affiliation': ""Centre for Affective Disorders, Institute of Psychiatry, Psychology & Neuroscience, King's College London, United Kingdom.""}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Moll', 'Affiliation': ""Cognitive and Behavioral Neuroscience Unit, Neuroinformatics Workgroup, D'Or Institute for Research and Education (IDOR), Rio de Janeiro, Brazil; Scients Institute, Palo Alto, USA. Electronic address: jorge.moll@idor.org.""}]",NeuroImage. Clinical,['10.1016/j.nicl.2019.101992'] 413,31352467,Neural responses during extinction learning predict exposure therapy outcome in phobia: results from a randomized-controlled trial.,"Extinction learning is assumed to represent a core mechanism underlying exposure therapy. Empirical evaluations of this assumption, however, are largely lacking. The current study investigated whether neural activations and self-report outcomes during extinction learning and extinction recall could specifically predict exposure therapy response in specific phobia. In this double-blind randomized controlled trial, individuals with spider phobia (N = 45; female/male = 41/4) were on group basis randomly allocated to exposure therapy (n = 25; female/male = 24/1) or progressive muscle relaxation (PMR; n = 20; female/male = 17/3). Intervention effects were measured with the Fears of Spiders questionnaire. Participants also underwent a three-day fear conditioning, extinction learning, and extinction recall paradigm during functional magnetic resonance imaging at baseline. Extinction outcomes were self-reported fear and threat expectancy, and neural responses during conditioned stimulus processing and during extinction-related prediction errors (US omissions) in regions of interest (ventromedial prefrontal cortex (vmPFC) and nucleus accumbens). Results showed that exposure therapy resulted in stronger symptom reductions than PMR (Cohen's d = 0.90). Exposure therapy response was specifically predicted by prediction-error related vmPFC activation during early extinction. There were also indications vmPFC activations during conditioned safety stimulus processing at early extinction predicted therapy outcome. Neural activations during extinction recall and self-report data did however not predict therapy outcome. These findings indicate that exposure therapy may rely on neural extinction learning processes. Prediction errors are thought to drive the extinction learning process, and prediction error-related vmPFC activation specifically predicted therapy outcome. The extent to which vmPFC processes safety signals may additionally be predictive of exposure therapy response, but the specificity is less clear.",2020,Results showed that exposure therapy resulted in stronger symptom reductions than PMR (Cohen's d = 0.90).,"['specific phobia', 'n\u2009=\u200920; female/male\u2009=\u200917/3', 'individuals with spider phobia (N\u2009=\u200945; female/male\u2009=\u200941/4', 'phobia']","['exposure therapy (n\u2009=\u200925; female/male\u2009=\u200924/1) or progressive muscle relaxation (PMR', 'extinction learning and extinction recall', 'extinction learning']","['stronger symptom reductions', 'Fears of Spiders questionnaire', 'self-reported fear and threat expectancy, and neural responses during conditioned stimulus processing and during extinction-related prediction errors (US omissions) in regions of interest', 'Neural responses']","[{'cui': 'C0236801', 'cui_str': 'Phobia, Specific'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0037913', 'cui_str': 'Spiders'}, {'cui': 'C0349231', 'cui_str': 'Phobias'}]","[{'cui': 'C0870527', 'cui_str': 'Exposure Therapy'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0004361', 'cui_str': 'Progressive Relaxation'}, {'cui': 'C0015347', 'cui_str': 'Extinction (Psychology)'}]","[{'cui': 'C0442821', 'cui_str': 'Strong (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0392331', 'cui_str': 'Arachnophobia (finding)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0234404', 'cui_str': 'Conditioned stimulus, function (observable entity)'}, {'cui': 'C0015347', 'cui_str': 'Extinction (Psychology)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}]",,0.103046,Results showed that exposure therapy resulted in stronger symptom reductions than PMR (Cohen's d = 0.90).,"[{'ForeName': 'Iris', 'Initials': 'I', 'LastName': 'Lange', 'Affiliation': 'Department of Psychiatry and Psychology, School for Mental Health and Neuroscience, EURON, Maastricht University Medical Centre, Maastricht, the Netherlands. i.lange@maastrichtuniversity.nl.'}, {'ForeName': 'Liesbet', 'Initials': 'L', 'LastName': 'Goossens', 'Affiliation': 'Department of Psychiatry and Psychology, School for Mental Health and Neuroscience, EURON, Maastricht University Medical Centre, Maastricht, the Netherlands.'}, {'ForeName': 'Stijn', 'Initials': 'S', 'LastName': 'Michielse', 'Affiliation': 'Department of Psychiatry and Psychology, School for Mental Health and Neuroscience, EURON, Maastricht University Medical Centre, Maastricht, the Netherlands.'}, {'ForeName': 'Jindra', 'Initials': 'J', 'LastName': 'Bakker', 'Affiliation': 'Department of Psychiatry and Psychology, School for Mental Health and Neuroscience, EURON, Maastricht University Medical Centre, Maastricht, the Netherlands.'}, {'ForeName': 'Bram', 'Initials': 'B', 'LastName': 'Vervliet', 'Affiliation': 'Faculty of Psychology and Educational Sciences, Laboratory of Biological Psychology, University of Leuven, Leuven, Belgium.'}, {'ForeName': 'Machteld', 'Initials': 'M', 'LastName': 'Marcelis', 'Affiliation': 'Department of Psychiatry and Psychology, School for Mental Health and Neuroscience, EURON, Maastricht University Medical Centre, Maastricht, the Netherlands.'}, {'ForeName': 'Marieke', 'Initials': 'M', 'LastName': 'Wichers', 'Affiliation': 'Department of Psychiatry, Interdisciplinary Center Psychopathology and Emotion Regulation (ICPE), University of Groningen, University Medical Center Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Jim', 'Initials': 'J', 'LastName': 'van Os', 'Affiliation': 'Department of Psychiatry and Psychology, School for Mental Health and Neuroscience, EURON, Maastricht University Medical Centre, Maastricht, the Netherlands.'}, {'ForeName': 'Therese', 'Initials': 'T', 'LastName': 'van Amelsvoort', 'Affiliation': 'Department of Psychiatry and Psychology, School for Mental Health and Neuroscience, EURON, Maastricht University Medical Centre, Maastricht, the Netherlands.'}, {'ForeName': 'Koen', 'Initials': 'K', 'LastName': 'Schruers', 'Affiliation': 'Department of Psychiatry and Psychology, School for Mental Health and Neuroscience, EURON, Maastricht University Medical Centre, Maastricht, the Netherlands.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0467-8'] 414,30484332,Impact of Combination of Local Anesthetic Wounds Infiltration and Ultrasound Transversus Abdominal Plane Block in Patients Undergoing Robot-Assisted Radical Prostatectomy: Perioperative Results of a Double-Blind Randomized Controlled Trial.,"OBJECTIVE To determinate benefits of the combination of local anesthetic wounds infiltration and ultrasound transversus abdominal plane (US-TAP) block with ropivacaine on postoperative pain, early recovery, and hospital stay in patients undergoing robot-assisted radical prostatectomy (RARP). METHODS The study is double-blinded randomized controlled trial. Our hypothesis was that the combination of wound infiltration and US-TAP block with ropivacaine would decrease immediate postoperative pain and opioids use. Primary outcomes included postoperative pain and opioids demand during the hospital stay. Secondary outcomes were nausea/vomiting rate, stool passing time, use of prokinetics, length of hospital stay (LOS), and 30-days readmission to the hospital for pain or other US-TAP block-related complications. RESULTS A total of 100 patients who underwent RARP were eligible for the analysis; 57 received the US-TAP block with 20 mL of 0.35% ropivacaine (US-TAP block group) and 43 did not receive US-TAP block (no-US-TAP group). All the patients received the local wound anesthetic infiltration with 20 mL of 0.35% ropivacaine. US-TAP block group showed a decreased mean Numerical Rating Scale (NRS) within 12 hours after surgery (1.6 vs 2.6; p = 0.02) and mean NRS (1.8 vs 2.7; p = 0.04) with lesser number of patients who used opioid (3.5% vs 18.6%; p = 0.01) during the first 24 hours. Moreover, we found a shorter mean LOS (4.27 vs 4.72, days; p = 0.04) with a lower requirement of prokinetics administration during the hospital stay (21% vs 72%; p < 0.001). No US-TAP block-related complications were reported. CONCLUSION Combination of anesthetic wound infiltration and US-TAP block with ropivacaine as part of a multimodal analgesic regimen can be safely offered to patients undergoing RARP and extended pelvic lymph node dissection. It improves the immediate postoperative pain control, reducing opioids administration and is associated to a decreased use of prokinetics and shorter hospital stay.",2019,"No US-TAP block-related complications were reported. ","['patients undergoing RARP and extended pelvic lymph node dissection', 'patients undergoing robot-assisted radical prostatectomy (RARP', '100 patients who underwent RARP were eligible for the analysis; 57 received the', 'Patients Undergoing Robot-Assisted Radical Prostatectomy']","['local anesthetic wounds infiltration and ultrasound transversus abdominal plane (US-TAP) block with ropivacaine', 'ropivacaine', 'US-TAP block with 20\u2009mL of 0.35% ropivacaine (US-TAP block group) and 43 did not receive US-TAP block', 'Local Anesthetic Wounds Infiltration and Ultrasound Transversus Abdominal Plane Block']","['postoperative pain, early recovery, and hospital stay', 'postoperative pain and opioids demand during the hospital stay', 'mean NRS', 'mean Numerical Rating Scale (NRS', 'nausea/vomiting rate, stool passing time, use of prokinetics, length of hospital stay (LOS), and 30-days readmission to the hospital for pain or other US-TAP block-related complications', 'shorter mean LOS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0729595', 'cui_str': 'Pelvic lymph node structure (body structure)'}, {'cui': 'C0012737', 'cui_str': 'Dissection'}, {'cui': 'C0336537', 'cui_str': 'Robot, device (physical object)'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0194810', 'cui_str': 'Radical prostatectomy (procedure)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}]","[{'cui': 'C0002921', 'cui_str': 'Local anesthesia (procedure)'}, {'cui': 'C0394871', 'cui_str': 'Wound infiltration (procedure)'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0000726', 'cui_str': 'Abdomen'}, {'cui': 'C0444660', 'cui_str': 'Plane (attribute)'}, {'cui': 'C0034115', 'cui_str': 'Puncture and Drainage'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C4517451', 'cui_str': 'Zero point three five'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}]","[{'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0030700', 'cui_str': 'Thirty Day Readmission'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0034115', 'cui_str': 'Puncture and Drainage'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}]",100.0,0.134726,"No US-TAP block-related complications were reported. ","[{'ForeName': 'Giovanni Enrico', 'Initials': 'GE', 'LastName': 'Cacciamani', 'Affiliation': '1 Departments of Urology, Italy.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Menestrina', 'Affiliation': '2 Department of Anesthesiologist and Intensive Care University of Verona, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Pirozzi', 'Affiliation': '1 Departments of Urology, Italy.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Tafuri', 'Affiliation': '1 Departments of Urology, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Corsi', 'Affiliation': '1 Departments of Urology, Italy.'}, {'ForeName': 'Davide', 'Initials': 'D', 'LastName': 'De Marchi', 'Affiliation': '1 Departments of Urology, Italy.'}, {'ForeName': 'Davide', 'Initials': 'D', 'LastName': 'Inverardi', 'Affiliation': '1 Departments of Urology, Italy.'}, {'ForeName': 'Tania', 'Initials': 'T', 'LastName': 'Processali', 'Affiliation': '1 Departments of Urology, Italy.'}, {'ForeName': ""Nicolo'"", 'Initials': 'N', 'LastName': 'Trabacchin', 'Affiliation': '1 Departments of Urology, Italy.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'De Michele', 'Affiliation': '1 Departments of Urology, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Sebben', 'Affiliation': '1 Departments of Urology, Italy.'}, {'ForeName': 'Maria Angela', 'Initials': 'MA', 'LastName': 'Cerruto', 'Affiliation': '1 Departments of Urology, Italy.'}, {'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'De Marco', 'Affiliation': '1 Departments of Urology, Italy.'}, {'ForeName': 'Filippo', 'Initials': 'F', 'LastName': 'Migliorini', 'Affiliation': '1 Departments of Urology, Italy.'}, {'ForeName': 'Antonio Benito', 'Initials': 'AB', 'LastName': 'Porcaro', 'Affiliation': '1 Departments of Urology, Italy.'}, {'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Artibani', 'Affiliation': '1 Departments of Urology, Italy.'}]",Journal of endourology,['10.1089/end.2018.0761'] 415,31634897,"Augmenting extinction learning with D-cycloserine reduces return of fear: a randomized, placebo-controlled fMRI study.","D-cycloserine (DCS), a partial NMDA-receptor agonist, seems to be a promising enhancer for exposure therapy in anxiety disorders. It has been tested successfully in animal models of fear extinction, where DCS enhanced extinction learning. Applied in clinical studies, results of DCS-augmented exposure therapy remain ambiguous, calling for a deeper understanding of the underlying mechanisms of DCS and its exact effect on extinction learning and return of fear (ROF) in humans. In the present study, we investigated the effect of DCS-augmented extinction learning on behavioral, psychophysiological, and neural indices of ROF during a 24-h delayed recall test. Thirty-seven participants entered a randomized, placebo-controlled, double-blind, 3-day fear conditioning and delayed extinction fMRI design. One hour before extinction training, participants received an oral dose of 50 mg of DCS or a placebo. Behavioral arousal ratings revealed a generalized ROF during extinction recall in the placebo but not DCS group. Furthermore, participants receiving DCS compared to placebo showed attenuated differential BOLD responses in left posterior hippocampus and amygdala from extinction learning to extinction recall, due to increased hippocampal recruitment in placebo and trendwise decreased amygdala responding in DCS subjects. Our finding that DCS reduces ROF in arousal ratings and neural structures subserving defensive reactions support a role for NMDA receptors in extinction memory consolidation and encourage further translational research.",2020,"Furthermore, participants receiving DCS compared to placebo showed attenuated differential BOLD responses in left posterior hippocampus and amygdala from extinction learning to extinction recall, due to increased hippocampal recruitment in placebo and trendwise decreased amygdala responding in DCS subjects.",['Thirty-seven participants'],"['placebo-controlled, double-blind, 3-day fear conditioning and delayed extinction fMRI design', 'DCS-augmented extinction learning', 'DCS', 'placebo', 'D-cycloserine (DCS']","['hippocampal recruitment', 'return of fear', 'behavioral, psychophysiological, and neural indices of ROF', 'extinction learning and return of fear (ROF', 'Behavioral arousal ratings', 'differential BOLD responses']","[{'cui': 'C4319569', 'cui_str': '37 (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0015347', 'cui_str': 'Extinction (Psychology)'}, {'cui': 'C0376335', 'cui_str': 'fMRI'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0010590', 'cui_str': 'Cycloserine'}]","[{'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0015347', 'cui_str': 'Extinction (Psychology)'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0443199', 'cui_str': 'Differential (qualifier value)'}]",37.0,0.340641,"Furthermore, participants receiving DCS compared to placebo showed attenuated differential BOLD responses in left posterior hippocampus and amygdala from extinction learning to extinction recall, due to increased hippocampal recruitment in placebo and trendwise decreased amygdala responding in DCS subjects.","[{'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Ebrahimi', 'Affiliation': 'Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Charitéplatz 1, 10117, Berlin, Germany. claudia.ebrahimi@charite.de.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Gechter', 'Affiliation': 'Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Charitéplatz 1, 10117, Berlin, Germany.'}, {'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'Lueken', 'Affiliation': 'Department of Psychology, Humboldt-Universität zu Berlin, Berlin, Germany.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Schlagenhauf', 'Affiliation': 'Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Charitéplatz 1, 10117, Berlin, Germany.'}, {'ForeName': 'Hans-Ulrich', 'Initials': 'HU', 'LastName': 'Wittchen', 'Affiliation': 'Institute of Clinical Psychology and Psychotherapy, Technische Universität Dresden, Dresden, Germany.'}, {'ForeName': 'Alfons O', 'Initials': 'AO', 'LastName': 'Hamm', 'Affiliation': 'Department of Biological and Clinical Psychology/Psychotherapy, University of Greifswald, Greifswald, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Ströhle', 'Affiliation': 'Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Charitéplatz 1, 10117, Berlin, Germany.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0552-z'] 416,31655485,Angiotensin involvement in trauma processing-exploring candidate neurocognitive mechanisms of preventing post-traumatic stress symptoms.,"The angiotensin-II antagonist losartan is a promising candidate that has enhanced extinction in a post-traumatic stress disorder (PTSD) animal model and was related to reducing PTSD symptom development in humans. Here, we investigate the neurocognitive mechanisms underlying these results, testing the effect of losartan on data-driven and contextual processing of traumatic material, mechanisms proposed to be relevant for PTSD development. In a double-blind between-subject design, 40 healthy participants were randomised to a single oral dose of losartan (50 mg) or placebo, 1 h before being exposed to distressing films as a trauma analogue while heart rate (HR) was measured. Peritraumatic processing was investigated using blurry picture stimuli from the films, which transformed into clear images. Data-driven processing was measured by the level of blurriness at which contents were recognised. Contextual processing was measured as the amount of context information retrieved when describing the pictures' contents. Negative-matched control images were used to test perceptual processing of peripheral trauma-cues. Post-traumatic stress symptoms were assessed via self-report questionnaires after analogue trauma and an intrusion diary completed over 4 days following the experiment. Compared to placebo, losartan facilitated contextual processing and enhanced detail perception in the negative-match pictures. During the films, the losartan group recorded lower HR and higher HR variability, reflecting lower autonomic stress responses. We discuss potential mechanisms of losartan in preventing PTSD symptomatology, including the role of reduced arousal and increased contextual processing during trauma exposure, as well as increased threat-safety differentiation when encountering peripheral trauma-cues in the aftermaths of traumatic events.",2020,"Compared to placebo, losartan facilitated contextual processing and enhanced detail perception in the negative-match pictures.",['40 healthy participants'],"['placebo', 'losartan', 'placebo, losartan', 'angiotensin-II antagonist losartan']","['contextual processing and enhanced detail perception', 'Contextual processing', 'lower HR and higher HR variability, reflecting lower autonomic stress responses']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0126174', 'cui_str': 'Losartan'}, {'cui': 'C0373546', 'cui_str': 'Angiotensin II measurement (procedure)'}, {'cui': 'C0243076', 'cui_str': 'antagonists'}]","[{'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0558058', 'cui_str': 'Reflecting (finding)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}]",40.0,0.0689031,"Compared to placebo, losartan facilitated contextual processing and enhanced detail perception in the negative-match pictures.","[{'ForeName': 'Lorika', 'Initials': 'L', 'LastName': 'Shkreli', 'Affiliation': 'Department of Psychiatry, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Marcella Lydia', 'Initials': 'ML', 'LastName': 'Woud', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Ruhr-Universität Bochum, Bochum, Germany.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Ramsbottom', 'Affiliation': 'Faculty of Health and Life Sciences, Oxford Brookes University, Oxford, UK.'}, {'ForeName': 'Aleksandra Ewa', 'Initials': 'AE', 'LastName': 'Rupietta', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Ruhr-Universität Bochum, Bochum, Germany.'}, {'ForeName': 'Gerd Thomas', 'Initials': 'GT', 'LastName': 'Waldhauser', 'Affiliation': 'Department of Neuropsychology, Ruhr-Universität Bochum, Bochum, Germany.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Kumsta', 'Affiliation': 'Genetic Psychology, Ruhr-Universität Bochum, Bochum, Germany.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Reinecke', 'Affiliation': 'Department of Psychiatry, Warneford Hospital, University of Oxford, Oxford, OX37JX, UK. andrea.reinecke@psych.ox.ac.uk.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0553-y'] 417,31913191,Primary Needle-Knife Fistulotomy Versus Conventional Cannulation Method in a High-Risk Cohort of Post-Endoscopic Retrograde Cholangiopancreatography Pancreatitis.,"OBJECTIVES Successful biliary cannulation is a prerequisite and important component of endoscopic retrograde cholangiopancreatography, but conventional cannulation methods (CCMs) have a postendoscopic retrograde cholangiopancreatography pancreatitis (PEP) rate of 14.1% in patients at high risk for PEP. The aim of this study was to evaluate the effectiveness and safety of needle-knife fistulotomy (NKF), compared with a CCM, when used for primary biliary access in patients at high risk for developing PEP. METHODS A total of 207 patients with one or more risk factors for PEP were prospectively enrolled. The patients were randomly allocated to one of 2 groups according to the primary biliary cannulation technique (NKF or CCM). We compared biliary cannulation success rates, cannulation and procedure times, and the incidence of adverse events, including PEP, between the groups. RESULTS The mean number of PEP risk factors was similar between the groups (NKF, 2.2 ± 1.0; CCM, 2.2 ± 0.9). PEP occurred in 8 patients in the CCM group and in no patients in the NKF group (9.2% vs 0%, P < 0.001). The rates of other adverse events did not differ between the groups. The biliary cannulation success rate was high in the NKF group, but relatively low in the CCM group, possibly because of the stringent failure criteria aimed at reducing PEP. However, the mean cannulation and total procedural times were longer in the NKF group than in the CCM group. DISCUSSION NKF is an effective and safe procedure to gain primary biliary access in patients at high risk for developing PEP. ClinicalTrials.gov, NCT02916199.",2020,"The biliary cannulation success rate was high in the NKF group, but relatively low in the CCM group, possibly because of the stringent failure criteria aimed at reducing PEP.","['High-Risk Cohort of Post-Endoscopic Retrograde Cholangiopancreatography Pancreatitis', '207 patients with one or more risk factors for PEP were prospectively enrolled', 'patients at high risk for developing PEP']","['primary biliary cannulation technique (NKF or CCM', 'Primary Needle-Knife Fistulotomy Versus Conventional Cannulation Method', 'needle-knife fistulotomy (NKF', 'CCM', 'NKF']","['PEP', 'mean cannulation and total procedural times', 'biliary cannulation success rates, cannulation and procedure times, and the incidence of adverse events, including PEP', 'mean number of PEP risk factors', 'rates of other adverse events', 'effectiveness and safety', 'biliary cannulation success rate']","[{'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0008310', 'cui_str': 'ERCP'}, {'cui': 'C0030305', 'cui_str': 'Pancreatitis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0359587', 'cui_str': 'Peptamen'}]","[{'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0917707', 'cui_str': 'Cannulation'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0181464', 'cui_str': 'Pre-cut needle knife'}, {'cui': 'C0744044', 'cui_str': 'Fistulotomy'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}]","[{'cui': 'C0359587', 'cui_str': 'Peptamen'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0917707', 'cui_str': 'Cannulation'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",207.0,0.0445235,"The biliary cannulation success rate was high in the NKF group, but relatively low in the CCM group, possibly because of the stringent failure criteria aimed at reducing PEP.","[{'ForeName': 'Sung Ill', 'Initials': 'SI', 'LastName': 'Jang', 'Affiliation': 'Department of Internal Medicine, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Dong Uk', 'Initials': 'DU', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Biomedical Research Institute, Pusan National University Hospital, Pusan National University School of Medicine, Pusan, South Korea.'}, {'ForeName': 'Jae Hee', 'Initials': 'JH', 'LastName': 'Cho', 'Affiliation': 'Department of Internal Medicine, Gachon University Gil Medical Center, Incheon, South Korea.'}, {'ForeName': 'Seok', 'Initials': 'S', 'LastName': 'Jeong', 'Affiliation': 'Department of Internal Medicine, Inha University School of Medicine, Incheon, South Korea.'}, {'ForeName': 'Jin-Seok', 'Initials': 'JS', 'LastName': 'Park', 'Affiliation': 'Department of Internal Medicine, Inha University School of Medicine, Incheon, South Korea.'}, {'ForeName': 'Don Haeng', 'Initials': 'DH', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, Inha University School of Medicine, Incheon, South Korea.'}, {'ForeName': 'Chang-Il', 'Initials': 'CI', 'LastName': 'Kwon', 'Affiliation': 'Digestive Disease Center, CHA Bundang Medical Center, CHA University, Seongnam, South Korea.'}, {'ForeName': 'Dong Hee', 'Initials': 'DH', 'LastName': 'Koh', 'Affiliation': 'Department of Internal Medicine, Hallym University Dongtan Sacred Heart Hospital, Hallym University College of Medicine, South Korea.'}, {'ForeName': 'Se Woo', 'Initials': 'SW', 'LastName': 'Park', 'Affiliation': 'Department of Internal Medicine, Hallym University Dongtan Sacred Heart Hospital, Hallym University College of Medicine, South Korea.'}, {'ForeName': 'Tae Hoon', 'Initials': 'TH', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, Soonchunhyang University College of Medicine, Cheonan Hospital, Cheonan, South Korea.'}, {'ForeName': 'Hye Sun', 'Initials': 'HS', 'LastName': 'Lee', 'Affiliation': 'Biostatistics Collaboration Unit, Yonsei University College of Medicine, Seoul, Korea.'}]",The American journal of gastroenterology,['10.14309/ajg.0000000000000480'] 418,32250250,Fractional flow reserve-guided multivessel angioplasty in myocardial infarction: three-year follow-up with cost benefit analysis of the Compare-Acute trial.,"AIMS The Compare-Acute trial showed superiority of fractional flow reserve (FFR)-guided acute complete revascularisation compared to culprit-only treatment in patients with ST-segment elevation myocardial infarction (STEMI) and multivessel disease (MVD) at one year. The aim of this study was to investigate the outcome at three years, together with cost analysis of this strategy. METHODS AND RESULTS After primary percutaneous coronary intervention (PCI), 885 patients with STEMI and MVD were randomised (1:2 ratio) to FFR-guided complete revascularisation (295 patients) or infarct-related artery (IRA)-only treatment (590 patients). After 36 months, the primary endpoint (composite of death, myocardial infarction, revascularisation, stroke) occurred significantly less frequently in the FFR-guided complete revascularisation group: 46/295 patients (15.6%) versus 178/590 patients (30.2%) (HR 0.46, 95% CI: 0.33-0.64; p<0.001). This benefit was driven mainly by the reduction of revascularisations in the follow-up (12.5% vs 25.2%; HR 0.45, 95% CI: 0.31-0.64; p<0.001). Cost analysis shows benefit of the FFR-guided complete revascularisation strategy, which can reduce the cost per patient by up to 21% at one year (8,150€ vs 10,319€) and by 22% at three years (8,653€ vs 11,100€). CONCLUSIONS In patients with STEMI and MVD, FFR-guided complete revascularisation is more beneficial in terms of outcome and healthcare costs compared to IRA-only revascularisation at 36 months.",2020,"In patients with STEMI and MVD, FFR-guided complete revascularization is more beneficial in terms of outcome and health-care costs compared to IRA-only revascularization at 36 months.","['Myocardial Infarction', 'patients with ST-segment elevation myocardial infarction (STEMI) and multivessel disease (MVD) at 1 year', '885 patients with STEMI and MVD']","['FFR-guided complete revascularization (295 patients) or infarct-related artery (IRA)-only treatment', 'Fractional Flow Reserve-Guided Multivessel Angioplasty', 'percutaneous coronary intervention (PCI', 'fractional flow reserve (FFR)-guided acute complete revascularization']","['point (composite of death, myocardial infarction, revascularization, stroke']","[{'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1536220', 'cui_str': 'ST Segment Elevation Myocardial Infarction'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021308', 'cui_str': 'Infarct'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1299469', 'cui_str': 'Fractional flow reserve'}, {'cui': 'C0162577', 'cui_str': 'Angioplasty of blood vessel'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}]",885.0,0.074449,"In patients with STEMI and MVD, FFR-guided complete revascularization is more beneficial in terms of outcome and health-care costs compared to IRA-only revascularization at 36 months.","[{'ForeName': 'Pieter C', 'Initials': 'PC', 'LastName': 'Smits', 'Affiliation': 'Department of Cardiology, Maastad Ziekenhuis, Rotterdam, the Netherlands.'}, {'ForeName': 'Pietro L', 'Initials': 'PL', 'LastName': 'Laforgia', 'Affiliation': ''}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Abdel-Wahab', 'Affiliation': ''}, {'ForeName': 'Franz-Josef', 'Initials': 'FJ', 'LastName': 'Neumann', 'Affiliation': ''}, {'ForeName': 'Gert', 'Initials': 'G', 'LastName': 'Richardt', 'Affiliation': ''}, {'ForeName': 'Bianca', 'Initials': 'B', 'LastName': 'Boxma-de Klerk', 'Affiliation': ''}, {'ForeName': 'Ketil', 'Initials': 'K', 'LastName': 'Lunde', 'Affiliation': ''}, {'ForeName': 'Carl E', 'Initials': 'CE', 'LastName': 'Schotborgh', 'Affiliation': ''}, {'ForeName': 'Zsolt', 'Initials': 'Z', 'LastName': 'Piroth', 'Affiliation': ''}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Horak', 'Affiliation': ''}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Wlodarczak', 'Affiliation': ''}, {'ForeName': 'Geert W', 'Initials': 'GW', 'LastName': 'Frederix', 'Affiliation': ''}, {'ForeName': 'Elmir', 'Initials': 'E', 'LastName': 'Omerovic', 'Affiliation': ''}]",EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology,['10.4244/EIJ-D-20-00012'] 419,32231293,Dose-dense adjuvant chemotherapy in early breast cancer patients: 15-year results of the Phase 3 Mammella InterGruppo (MIG)-1 study.,"BACKGROUND Adjuvant chemotherapy is the standard of care in high-risk early breast cancer patients. Dose-dense should be the preferred schedule of administration. However, its long-term benefit is unknown. METHODS In the Italian multicentre Phase 3 randomised MIG-1 trial, node-positive and high-risk node- negative breast cancer patients were randomised to receive six cycles of adjuvant fluorouracil, epirubicin and cyclophosphamide regimen administered every 3 (FEC21) or 2 (FEC14) weeks. The primary endpoint was overall survival (OS), and the secondary endpoint was event-free survival (EFS). RESULTS From 1992 to 1997, 1214 patients were included. Median follow-up was 15.8 years. In all, 15-year OS was 71% and 68% in the FEC14 and FEC21 groups, respectively (HR = 0.89; p = 0.25). In all, 15-year EFS was 47% and 43% in the FEC14 and FEC21 groups, respectively (HR = 0.87; p = 0.18). In a pre-planned subgroup analysis, among patients with hormone receptor-negative tumours, 15-year OS was 70% and 65% in the FEC14 and FEC21 groups, respectively (HR = 0.73; 95% CI: 0.51-1.06); 15-year EFS was 58% and 43% in the FEC14 and FEC21 groups, respectively (HR = 0.70; 95% CI: 0.51-0.96). CONCLUSIONS Updated results from the MIG-1 study are numerically in favour of dose-dense chemotherapy, and suggest a long-term benefit of this approach in high-risk early breast cancer patients.",2020,"In all, 15-year OS was 71% and 68% in the FEC14 and FEC21 groups, respectively (HR = 0.89; p = 0.25).","['From 1992 to 1997, 1214 patients were included', 'node-positive and high-risk node- negative breast cancer patients', 'high-risk early breast cancer patients', 'early breast cancer patients']","['adjuvant fluorouracil, epirubicin and cyclophosphamide', 'Dose-dense adjuvant chemotherapy']","['15-year OS', 'overall survival (OS), and the secondary endpoint was event-free survival (EFS', '15-year EFS']","[{'cui': 'C0456592', 'cui_str': '1992 (qualifier value)'}, {'cui': 'C0730225', 'cui_str': '1997 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C3160889', 'cui_str': 'Node-negative breast cancer'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}]","[{'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0014582', 'cui_str': 'Epirubicin'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0439794', 'cui_str': 'Dense (qualifier value)'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}]","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}]",1214.0,0.167571,"In all, 15-year OS was 71% and 68% in the FEC14 and FEC21 groups, respectively (HR = 0.89; p = 0.25).","[{'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Blondeaux', 'Affiliation': 'Department of Medical Oncology U.O. Oncologia Medica 2, IRCCS Ospedale Policlinico San Martino, Largo R. Benzi 10, 16132, Genova, Italy.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Lambertini', 'Affiliation': 'Department of Medical Oncology U.O.C. Clinica di Oncologia Medica, IRCCS Ospedale Policlinico San Martino, Largo R. Benzi 10, 16132, Genova, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Michelotti', 'Affiliation': 'Department of Oncology, Transplants and new Technologies U.O. Oncologia Medica I, Ospedale S. Chiara, Azienda Ospedaliera Universitaria Pisana, Via Roma 67, 56100, Pisa, Italy.'}, {'ForeName': 'Benedetta', 'Initials': 'B', 'LastName': 'Conte', 'Affiliation': 'Department of Medical Oncology U.O. Oncologia Medica 2, IRCCS Ospedale Policlinico San Martino, Largo R. Benzi 10, 16132, Genova, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Benasso', 'Affiliation': 'Medical Oncology, Ospedale San Paolo, Via Genova 30, 17100, Savona, Italy.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Dellepiane', 'Affiliation': 'Department of Medical Oncology U.O. Oncologia Medica 2, IRCCS Ospedale Policlinico San Martino, Largo R. Benzi 10, 16132, Genova, Italy.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Bighin', 'Affiliation': 'Department of Medical Oncology U.O. Oncologia Medica 2, IRCCS Ospedale Policlinico San Martino, Largo R. Benzi 10, 16132, Genova, Italy.'}, {'ForeName': 'Simona', 'Initials': 'S', 'LastName': 'Pastorino', 'Affiliation': 'Department of Medical Oncology U.O. Oncologia Medica 2, IRCCS Ospedale Policlinico San Martino, Largo R. Benzi 10, 16132, Genova, Italy.'}, {'ForeName': 'Alessia', 'Initials': 'A', 'LastName': 'Levaggi', 'Affiliation': 'Department of Medical Oncology U.O.C. Clinica di Oncologia Medica, IRCCS Ospedale Policlinico San Martino, Largo R. Benzi 10, 16132, Genova, Italy.'}, {'ForeName': ""Alessia D'"", 'Initials': 'A', 'LastName': 'Alonzo', 'Affiliation': 'Department of Medical Oncology U.O. Oncologia Medica 2, IRCCS Ospedale Policlinico San Martino, Largo R. Benzi 10, 16132, Genova, Italy.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Poggio', 'Affiliation': 'Department of Medical Oncology U.O. Oncologia Medica 2, IRCCS Ospedale Policlinico San Martino, Largo R. Benzi 10, 16132, Genova, Italy.'}, {'ForeName': 'Giulia', 'Initials': 'G', 'LastName': 'Buzzatti', 'Affiliation': 'Department of Medical Oncology U.O. Oncologia Medica 2, IRCCS Ospedale Policlinico San Martino, Largo R. Benzi 10, 16132, Genova, Italy.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Molinelli', 'Affiliation': 'Department of Medical Oncology U.O. Oncologia Medica 2, IRCCS Ospedale Policlinico San Martino, Largo R. Benzi 10, 16132, Genova, Italy.'}, {'ForeName': 'Piero', 'Initials': 'P', 'LastName': 'Fregatti', 'Affiliation': 'Department of Integrated Diagnostic Surgical Sciences, U.O. Clinica di chirurgia senologica, IRCCS Ospedale Policlinico San Martino, Largo R. Benzi 10, 16132, Genova, Italy.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Bertoglio', 'Affiliation': 'Department of Surgical Sciences (DISC), University of Genova, Largo Rosanna Benzi 10, 16132, Genova, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Boccardo', 'Affiliation': 'Department of Medical Oncology U.O.C. Clinica di Oncologia Medica, IRCCS Ospedale Policlinico San Martino, Largo R. Benzi 10, 16132, Genova, Italy.'}, {'ForeName': 'Lucia', 'Initials': 'L', 'LastName': 'Del Mastro', 'Affiliation': 'Department of Medical Oncology U.O. Oncologia Medica 2, IRCCS Ospedale Policlinico San Martino, Largo R. Benzi 10, 16132, Genova, Italy. lucia.delmastro@hsanmartino.it.'}]",British journal of cancer,['10.1038/s41416-020-0816-8'] 420,32251265,Blood-based biomarkers for prediction of intracranial hemorrhage and outcome in patients with moderate or severe traumatic brain injury.,"BACKGROUND Early identification of traumatic intracranial hemorrhage (ICH) has implications for triage and intervention. Blood-based biomarkers were recently approved by the Food and Drug Administration (FDA) for prediction of ICH in patients with mild traumatic brain injury (TBI). We sought to determine if biomarkers measured early after injury improve prediction of mortality and clinical/radiologic outcomes compared with Glasgow Coma Scale (GCS) alone in patients with moderate or severe TBI (MS-TBI). METHODS We measured glial fibrillary acidic protein (GFAP), ubiquitin C-terminal hydrolase L1 (UCH-L1), and microtubule-associated protein-2 (MAP-2) on arrival to the emergency department (ED) in patients with blunt TBI enrolled in the placebo arm of the Prehospital TXA for TBI Trial (prehospital GCS score, 3-12; SPB, > 90). Biomarkers were modeled individually and together with prehospital predictor variables [PH] (GCS score, age, sex). Data were divided into a training data set and test data set for model derivation and evaluation. Models were evaluated for prediction of ICH, mass lesion, 48-hour and 28-day mortality, and 6-month Glasgow Outcome Scale-Extended (GOS-E) and Disability Rating Scale (DRS). Area under the curve (AUC) was evaluated in test data for PH alone, PH + individual biomarkers, and PH + three biomarkers. RESULTS Of 243 patients with baseline samples (obtained a median of 84 minutes after injury), prehospital GCS score was 8 (interquartile range, 5-10), 55% had ICH, and 48-hour and 28-day mortality were 7% and 13%, respectively. Poor neurologic outcome at 6 months was observed in 34% based on GOS-E of 4 or less, and 24% based on DRS greater than or equal to7. Addition of each biomarker to PH improved AUC in the majority of predictive models. GFAP+PH compared with PH alone significantly improved AUC in all models (ICH, 0.82 vs. 0.64; 48-hour mortality, 0.84 vs. 0.71; 28-day mortality, 0.84 vs. 0.66; GOS-E, 0.78 vs. 0.69; DRS, 0.84 vs. 0.81, all p < 0.001). CONCLUSION Circulating blood-based biomarkers may improve prediction of neurological outcomes and mortality in patients with MS-TBI over prehospital characteristics alone. Glial fibrillary acidic protein appears to be the most promising. Future evaluation in the prehospital setting is warranted. LEVEL OF EVIDENCE Prospective, Prognostic and Epidemiological, level II.",2020,"GFAP+PH compared to PH alone significantly improved AUC in all models [ICH: 0.82 vs 0.64; 48-hour mortality 0.84 vs 0.71; 28-day mortality: 0.84 vs 0.66; GOSE: 0.78 vs 0.69; DRS 0.84 vs 0.81, all p<0.001]. ","['patients with mild TBI', 'traumatic intracranial hemorrhage (ICH', '243 patients with baseline samples', 'patients with moderate or severe TBI (MS-TBI', 'patients with blunt TBI enrolled in the placebo arm of the Prehospital TXA for TBI Trial (prehospital GCS 3-12, SPB > 90', 'patients with MS-TBI over prehospital characteristics alone']","['GCS', 'GFAP', 'GFAP+PH']","['AUC', 'prediction of ICH, mass lesion, 48-hour and 28-day mortality, and 6-month Glasgow Outcome Scale-Extended [GOSE] and Disability Rating Scale [DRS', 'Poor neurologic outcome', 'glial-fibrillary-acidic-protein (GFAP), ubiquitin-C-terminal-hydrolase-L1 (UCH-L1), and microtubule-associated-protein-2 (MAP-2', 'prehospital GCS', 'mortality and clinical/radiologic outcomes', 'ICH, and 48-hr and 28-day mortality']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0043162', 'cui_str': 'Total body irradiation'}, {'cui': 'C0273058', 'cui_str': 'Intracranial hemorrhage following injury'}, {'cui': 'C0019191', 'cui_str': 'Infectious Canine Hepatitis'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1997138', 'cui_str': 'Blunted'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1522376', 'cui_str': 'GCLC protein, human'}, {'cui': 'C0597729', 'cui_str': 'Spindle Pole Body'}, {'cui': 'C0439083', 'cui_str': '>90'}]","[{'cui': 'C1522376', 'cui_str': 'GCLC protein, human'}, {'cui': 'C0017626', 'cui_str': 'Glial fibrillary acidic protein'}]","[{'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0019191', 'cui_str': 'Infectious Canine Hepatitis'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0439586', 'cui_str': '48 hours'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0701887', 'cui_str': 'Glasgow outcome scale'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0451125', 'cui_str': 'Disability rating scale'}, {'cui': 'C0013261', 'cui_str': ""Duane's syndrome""}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0017626', 'cui_str': 'Glial fibrillary acidic protein'}, {'cui': 'C0164005', 'cui_str': 'Ubiquitin thiolesterase'}, {'cui': 'C1436157', 'cui_str': 'UCHL1 protein, human'}, {'cui': 'C0024773', 'cui_str': 'MAP2 Microtubule-Associated Protein'}, {'cui': 'C1433609', 'cui_str': 'METAP2 protein, human'}, {'cui': 'C1522376', 'cui_str': 'GCLC protein, human'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0034599', 'cui_str': 'Radiology - specialty'}]",243.0,0.0609947,"GFAP+PH compared to PH alone significantly improved AUC in all models [ICH: 0.82 vs 0.64; 48-hour mortality 0.84 vs 0.71; 28-day mortality: 0.84 vs 0.66; GOSE: 0.78 vs 0.69; DRS 0.84 vs 0.81, all p<0.001]. ","[{'ForeName': 'Taylor N', 'Initials': 'TN', 'LastName': 'Anderson', 'Affiliation': 'From the School of Medicine (T.N.A.), Department of Neurology (H.E.H.), Department of Surgery (S.E.R.), Oregon Health and Science University, Portland, Oregon; Department of Biostatistics (J.H.), University of Washington, Seattle, Washington; College of Pharmacy (M.M.), Oregon State University, Corvallis, Oregon; Department of Emergency Medicine (L.P.), Orlando Regional Medical Center, Orlando, Florida; Department of Surgery (A.V.), Mercer University School of Medicine, Macon, Georgia; and Department of Surgery (S.E.R.), Duke University Medical Center, Durham, North Carolina.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Hwang', 'Affiliation': ''}, {'ForeName': 'Myrna', 'Initials': 'M', 'LastName': 'Munar', 'Affiliation': ''}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Papa', 'Affiliation': ''}, {'ForeName': 'Holly E', 'Initials': 'HE', 'LastName': 'Hinson', 'Affiliation': ''}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Vaughan', 'Affiliation': ''}, {'ForeName': 'Susan E', 'Initials': 'SE', 'LastName': 'Rowell', 'Affiliation': ''}]",The journal of trauma and acute care surgery,['10.1097/TA.0000000000002706'] 421,32141709,"Mesh inlay, mesh kit or native tissue repair for women having repeat anterior or posterior prolapse surgery: randomised controlled trial (PROSPECT).","OBJECTIVE To compare standard (native tissue) repair with synthetic mesh inlays or mesh kits. DESIGN Randomised controlled trial. SETTING Thirty-three UK hospitals. POPULATION Women having surgery for recurrent prolapse. METHODS Women recruited using remote randomisation. MAIN OUTCOME MEASURES Prolapse symptoms, condition-specific quality-of-life and serious adverse effects. RESULTS A Mean Pelvic Organ Prolapse Symptom Score at 1 year was similar for each comparison (standard 6.6 versus mesh inlay 6.1, mean difference [MD] -0.41, 95% CI -2.92 to 2.11: standard 6.6 versus mesh kit 5.9, MD -1.21 , 95% CI -4.13 to 1.72) but the confidence intervals did not exclude a minimally important clinical difference. There was no evidence of difference in any other outcome measure at 1 or 2 years. Serious adverse events, excluding mesh exposure, were similar at 1 year (standard 7/55 [13%] versus mesh inlay 5/52 [10%], risk ratio [RR] 1.05 [0.66-1.68]: standard 3/25 [12%] versus mesh kit 3/46 [7%], RR 0.49 [0.11-2.16]). Cumulative mesh exposure rates over 2 years were 7/52 (13%) in the mesh inlay arm, of whom four women required surgical revision; and 4/46 in the mesh kit arm (9%), of whom two required surgical revision. CONCLUSIONS We did not find evidence of a difference in terms of prolapse symptoms from the use of mesh inlays or mesh kits in women undergoing repeat prolapse surgery. Although the sample size was too small to be conclusive, the results provide a substantive contribution to future meta-analysis. TWEETABLE ABSTRACT There is not enough evidence to support use of synthetic mesh inlay or mesh kits for repeat prolapse surgery.",2020,We did not find evidence of a difference in terms of prolapse symptoms from the use of mesh inlays or mesh kits in women undergoing repeat prolapse surgery.,"['Women having surgery for recurrent prolapse', 'women undergoing repeat prolapse surgery', 'Women recruited using remote randomisation', '33 UK hospitals', 'women having repeat anterior or posterior prolapse surgery']","['standard (native tissue) repair against synthetic mesh inlays or mesh kits', 'Mesh inlay, mesh kit or native tissue repair']","['Mean Pelvic Organ Prolapse Symptom Score', 'surgical revision', 'prolapse symptoms', 'Prolapse symptoms, condition specific quality-of-life and serious adverse effects', 'Cumulative mesh exposure rates']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0033377', 'cui_str': 'Prolapse'}, {'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C0205157', 'cui_str': 'Remote (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0302891', 'cui_str': 'Native (qualifier value)'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C0374711', 'cui_str': 'Surgical repair (procedure)'}, {'cui': 'C0181805', 'cui_str': 'Mesh (physical object)'}, {'cui': 'C0021513', 'cui_str': 'Dental Inlays'}, {'cui': 'C1690540', 'cui_str': 'Kit'}, {'cui': 'C0043240', 'cui_str': 'Wound Healing'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0877015', 'cui_str': 'Urogenital Prolapse'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0035110', 'cui_str': 'Revision Surgery'}, {'cui': 'C0033377', 'cui_str': 'Prolapse'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0034380'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0181805', 'cui_str': 'Mesh (physical object)'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}]",4.0,0.336306,We did not find evidence of a difference in terms of prolapse symptoms from the use of mesh inlays or mesh kits in women undergoing repeat prolapse surgery.,"[{'ForeName': 'Cma', 'Initials': 'C', 'LastName': 'Glazener', 'Affiliation': 'Health Services Research Unit, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Breeman', 'Affiliation': 'Health Services Research Unit, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Elders', 'Affiliation': 'NMAHP Research Unit, Glasgow Caledonian University, Glasgow, UK.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Hemming', 'Affiliation': 'Department of Obstetrics and Gynaecology, Aberdeen Royal Infirmary, Aberdeen, UK.'}, {'ForeName': 'K G', 'Initials': 'KG', 'LastName': 'Cooper', 'Affiliation': 'Department of Obstetrics and Gynaecology, Aberdeen Royal Infirmary, Aberdeen, UK.'}, {'ForeName': 'R M', 'Initials': 'RM', 'LastName': 'Freeman', 'Affiliation': 'Department of Obstetrics and Gynaecology, Plymouth Hospitals NHS Trust, Plymouth, UK.'}, {'ForeName': 'Arb', 'Initials': 'A', 'LastName': 'Smith', 'Affiliation': ""St Mary's Hospital, Manchester University Hospitals NHS Foundation Trust, Manchester Academic Health Science Centre, Manchester, UK.""}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Hagen', 'Affiliation': 'NMAHP Research Unit, Glasgow Caledonian University, Glasgow, UK.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Montgomery', 'Affiliation': 'Health Services Research Unit, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Kilonzo', 'Affiliation': 'Health Economics Research Unit, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Boyers', 'Affiliation': 'Health Economics Research Unit, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'McDonald', 'Affiliation': 'Health Services Research Unit, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'McPherson', 'Affiliation': 'Health Services Research Unit, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'MacLennan', 'Affiliation': 'Health Services Research Unit, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Norrie', 'Affiliation': 'Usher Institute of Population Health Sciences & Informatics, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'F M', 'Initials': 'FM', 'LastName': 'Reid', 'Affiliation': ""St Mary's Hospital, Manchester University Hospitals NHS Foundation Trust, Manchester Academic Health Science Centre, Manchester, UK.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BJOG : an international journal of obstetrics and gynaecology,['10.1111/1471-0528.16197'] 422,32092160,Optimising epilepsy management with a smartphone application: a randomised controlled trial.,"OBJECTIVE To assess whether a practical intervention based upon a smartphone application (app) would improve self-management and seizure control in adults with epilepsy. DESIGN, SETTING Randomised, controlled trial in western China, December 2017 to August 2018. PARTICIPANTS 380 eligible people with epilepsy were recruited; 327 completed the 6-month follow-up (176 in the app group, 151 in the control group). MAIN OUTCOME MEASURES Self-management of epilepsy (measured with the validated Chinese Epilepsy Self-Management Scale, C-ESMS) and self-reported seizure frequency. RESULTS In the intention-to-treat analysis, the mean C-ESMS score increased significantly in the app group between baseline and the 6-month evaluation (from 121.7 [SD, 12.1] to 144.4 [SD, 10.0]; P < 0.001); improvements on the information management, medication management, and safety management subscales were also statistically significant. At 6 months, the mean overall C-ESMS score for the app group was significantly higher than that for the control group (125.4 [SD, 1.5];  P < 0.001). The proportion of patients who were seizure-free at the 6-month follow-up was larger for the app than the control group (54 of 190, 28% v 22 of 190, 12%), as was the proportion with reductions in frequency of between 75 and 100% (22 of 190, 12% v 8 of 190, 4%). Changes in C-ESMS score were not statistically associated with seizure frequency. CONCLUSIONS Using a smartphone app improved epilepsy self-management scores in people in western China. It should be further tested in larger populations in other areas. Our preliminary investigation of building digital communities for people with epilepsy should encourage similar approaches to managing other chronic diseases. TRIAL REGISTRATION Chinese Clinical Trial Registry, ChiCTR1900026864, 24 October 2019.",2020,"In the intention-to-treat analysis, the mean C-ESMS score increased significantly in the app group between baseline and the 6-month evaluation (from 121.7 [SD, 12.1] to 144.4 [SD, 10.0]; P < 0.001); improvements on the information management, medication management, and safety management subscales were also statistically significant.","['people with epilepsy', 'adults with epilepsy', 'western China, December 2017 to August 2018', '24 October 2019', '380 eligible people with epilepsy were recruited; 327 completed the 6-month follow-up (176 in the app group, 151 in the control group', 'people in western China']","['smartphone', 'smartphone application', 'smartphone application (app']","['information management, medication management, and safety management subscales', 'epilepsy self-management scores', 'Self-management of epilepsy (measured with the validated Chinese Epilepsy Self-Management Scale, C-ESMS) and self-reported seizure frequency', 'mean overall C-ESMS score', 'mean C-ESMS score', 'Changes in C-ESMS score']","[{'cui': 'C0014544', 'cui_str': 'Seizure Disorder'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}, {'cui': 'C4319693', 'cui_str': 'Three hundred and eighty'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}]","[{'cui': 'C0012972', 'cui_str': 'Information Management'}, {'cui': 'C0150270', 'cui_str': 'Medication administration case management'}, {'cui': 'C0206216', 'cui_str': 'Safety Management'}, {'cui': 'C0014544', 'cui_str': 'Seizure Disorder'}, {'cui': 'C0086969', 'cui_str': 'Self-Management'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0222045'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0443172', 'cui_str': 'State changes'}]",,0.118807,"In the intention-to-treat analysis, the mean C-ESMS score increased significantly in the app group between baseline and the 6-month evaluation (from 121.7 [SD, 12.1] to 144.4 [SD, 10.0]; P < 0.001); improvements on the information management, medication management, and safety management subscales were also statistically significant.","[{'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Si', 'Affiliation': ""Sichuan Academy of Medical Sciences and Sichuan People's Hospital, Chengdu, Sichuan, China.""}, {'ForeName': 'Xiaoqiang', 'Initials': 'X', 'LastName': 'Xiao', 'Affiliation': ""Sichuan Academy of Medical Sciences and Sichuan People's Hospital, Chengdu, Sichuan, China.""}, {'ForeName': 'Cai', 'Initials': 'C', 'LastName': 'Xia', 'Affiliation': ""Sichuan Provincial Center for Mental Health, Sichuan Academy of Medical Sciences and Sichuan People's Hospital, Chengdu, Sichuan, China.""}, {'ForeName': 'Jiang', 'Initials': 'J', 'LastName': 'Guo', 'Affiliation': ""Sichuan Academy of Medical Sciences and Sichuan People's Hospital, Chengdu, Sichuan, China.""}, {'ForeName': 'Qiukui', 'Initials': 'Q', 'LastName': 'Hao', 'Affiliation': 'National Clinical Research Center for Geriatrics, Sichuan University West China Hospital, Chengdu, Sichuan, China.'}, {'ForeName': 'Qianning', 'Initials': 'Q', 'LastName': 'Mo', 'Affiliation': ""Sichuan Academy of Medical Sciences and Sichuan People's Hospital, Chengdu, Sichuan, China.""}, {'ForeName': 'Yulong', 'Initials': 'Y', 'LastName': 'Niu', 'Affiliation': 'Key Laboratory of Bio-Resource and Eco-Environment, College of Life Sciences, Sichuan University, Chengdu, Sichuan, China.'}, {'ForeName': 'Hongbin', 'Initials': 'H', 'LastName': 'Sun', 'Affiliation': ""Sichuan Academy of Medical Sciences and Sichuan People's Hospital, Chengdu, Sichuan, China.""}]",The Medical journal of Australia,['10.5694/mja2.50520'] 423,32224082,Orthognathic Surgery-Induced Fibrinolytic Shutdown Is Amplified by Tranexamic Acid.,"PURPOSE Little is known of the systemic effects of oral and maxillofacial surgery on the hemostatic balance, including the biochemical effects of tranexamic acid (TXA), on fibrin clot lysis. The present study investigated the effects of orthognathic surgery on fibrin lysis, fibrin structure, and D-dimer and evaluated the effect of TXA on these fibrinolytic measures. MATERIALS AND METHODS The present double-blind, controlled, and randomized, placebo study included patients referred to the Department of Oral and Maxillofacial Surgery at the University Hospital of Southern Denmark-Esbjerg from August 2014 through September 2016. The patients were elective and had a diagnosis of maxillary or mandibular deficiency, either excessive or asymmetric. All patients underwent bimaxillary orthognathic surgery (OS) with or without maxillary segmentation or additional genioplasty. The patients were blindly randomized to treatment with TXA or placebo. The primary predictor variable was OS. The secondary predictor variable was an intravenous dose of 1 g of TXA or equivalent placebo preoperatively. Blood samples were collected before surgery and 5 hours after the initiation of surgery. The primary outcome variable was lysis of fibrin. The fibrin structure properties and D-dimer were secondary outcome measures. The Mann-Whitney U test was used for the within-group comparisons. The Wilcoxon signed rank test was used for the between-group comparisons. RESULTS The sample included 96 patients; 45 received placebo and 51 received TXA. Fibrin lysis decreased after OS (P < .001). The fibrinolytic shutdown decreased significantly more in the TXA group than in the placebo group (P < .001). OS altered the fibrin structure properties with comparable effects in the 2 groups. D-dimer increased postoperatively but significantly less so in the TXA group than in the control group (P < .001). CONCLUSIONS OS is associated with fibrinolytic shutdown and alters fibrin structure properties, driving the hemostatic balance in a prothrombotic direction. The fibrinolytic shutdown is significantly amplified by TXA.",2020,"D-dimer increased postoperatively but significantly less so in the TXA group than in the control group (P < .001). ","['patients were elective and had a diagnosis of maxillary or mandibular deficiency, either excessive or asymmetric', 'patients referred to the Department of Oral and Maxillofacial Surgery at the University Hospital of Southern Denmark-Esbjerg from August 2014 through September 2016', 'The sample included 96 patients; 45 had received']","['Tranexamic Acid', 'placebo', 'maxillofacial surgery', 'bimaxillary orthognathic surgery (OS) with or without maxillary segmentation or additional genioplasty', 'TXA', 'TXA or placebo', 'tranexamic acid (TXA', 'orthognathic surgery']","['Blood samples', 'Fibrin lysis', 'lysis of fibrin', 'OS', 'fibrinolytic shutdown', 'fibrin lysis, fibrin structure, and D-dimer']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0011155', 'cui_str': 'Deficient (qualifier value)'}, {'cui': 'C0442802', 'cui_str': 'Excessive (qualifier value)'}, {'cui': 'C0812928', 'cui_str': 'Oral and maxillofacial surgery'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0038908', 'cui_str': 'Surgery, Maxillofacial'}, {'cui': 'C0185624', 'cui_str': 'Orthognathic Surgery'}, {'cui': 'C0700381', 'cui_str': 'Segmentation (qualifier value)'}, {'cui': 'C0398907', 'cui_str': 'Chin Repositioning'}]","[{'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0015982', 'cui_str': 'Fibrin'}, {'cui': 'C0024348', 'cui_str': 'Lysis (morphologic abnormality)'}, {'cui': 'C0060323', 'cui_str': 'D-dimer fragments'}]",96.0,0.195453,"D-dimer increased postoperatively but significantly less so in the TXA group than in the control group (P < .001). ","[{'ForeName': 'Johannes J', 'Initials': 'JJ', 'LastName': 'Sidelmann', 'Affiliation': 'Associate Professor, Unit for Thrombosis Research, Department of Regional Health Research, University of Southern Denmark; and Department of Clinical Biochemistry, University Hospital of Southern Denmark - Esbjerg, Esbjerg, Denmark. Electronic address: johannes.sidelmann@rsyd.dk.'}, {'ForeName': 'Jørgen B', 'Initials': 'JB', 'LastName': 'Gram', 'Affiliation': 'Professor, Unit for Thrombosis Research, Department of Regional Health Research, University of Southern Denmark; and Department of Clinical Biochemistry, University Hospital of Southern Denmark - Esbjerg, Esbjerg, Denmark.'}, {'ForeName': 'Anne C M', 'Initials': 'ACM', 'LastName': 'Godtfredsen', 'Affiliation': 'Research Fellow, Unit for Thrombosis Research, Department of Regional Health Research, University of Southern Denmark; and Department of Clinical Biochemistry, University Hospital of Southern Denmark - Esbjerg, Esbjerg, Denmark.'}, {'ForeName': 'Jens J', 'Initials': 'JJ', 'LastName': 'Thorn', 'Affiliation': 'Head of Department, Department of Oral and Maxillofacial Surgery, University Hospital of Southern Denmark - Esbjerg, Esbjerg, Denmark.'}, {'ForeName': 'Janne', 'Initials': 'J', 'LastName': 'Ingerslev', 'Affiliation': 'Senior Consultant, Department of Oral and Maxillofacial Surgery, University Hospital of Southern Denmark - Esbjerg, Esbjerg, Denmark.'}, {'ForeName': 'Else M', 'Initials': 'EM', 'LastName': 'Pinholt', 'Affiliation': 'Professor, Department of Oral and Maxillofacial Surgery, University Hospital of Southern Denmark - Esbjerg; and Department of Regional Health Research, University of Southern Denmark, Esbjerg, Denmark.'}]",Journal of oral and maxillofacial surgery : official journal of the American Association of Oral and Maxillofacial Surgeons,['10.1016/j.joms.2020.02.026'] 424,32105893,"Invited commentary on ""Topical 5% minoxidil versus topical 0.2% glyceryl trinitrate in treatment of chronic anal fissure: A randomized clinical trial"".",,2020,,['Chronic Anal Fissure'],['Topical 5% Minoxidil versus Topical 0.2% Glyceryl Trinitrate'],[],"[{'cui': 'C0349071', 'cui_str': 'Chronic anal fissure (disorder)'}]","[{'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0026196', 'cui_str': 'Minoxidil'}, {'cui': 'C4517436', 'cui_str': '0.2'}, {'cui': 'C0017887', 'cui_str': 'glyceryl trinitrate'}]",[],,0.0400785,,"[{'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Williams', 'Affiliation': 'Formerly General Surgeon at the Kent and Sussex Hospital in Tunbridge Wells, Kent, UK. Electronic address: twill30999@aol.com.'}]","International journal of surgery (London, England)",['10.1016/j.ijsu.2020.02.028'] 425,31733631,"Distinct acute effects of LSD, MDMA, and D-amphetamine in healthy subjects.","Lysergic acid diethylamide (LSD) is a classic psychedelic, 3,4-methylenedioxymethamphetamine (MDMA) is an empathogen, and D-amphetamine is a classic stimulant. All three substances are used recreationally. LSD and MDMA are being investigated as medications to assist psychotherapy, and D-amphetamine is used for the treatment of attention-deficit/hyperactivity disorder. All three substances induce distinct acute subjective effects. However, differences in acute responses to these prototypical psychoactive substances have not been characterized in a controlled study. We investigated the acute autonomic, subjective, and endocrine effects of single doses of LSD (0.1 mg), MDMA (125 mg), D-amphetamine (40 mg), and placebo in a randomized, double-blind, cross-over study in 28 healthy subjects. All of the substances produced comparable increases in hemodynamic effects, body temperature, and pupil size, indicating equivalent autonomic responses at the doses used. LSD and MDMA increased heart rate more than D-amphetamine, and D-amphetamine increased blood pressure more than LSD and MDMA. LSD induced significantly higher ratings on the 5 Dimensions of Altered States of Consciousness scale and Mystical Experience Questionnaire than MDMA and D-amphetamine. LSD also produced greater subjective drug effects, ego dissolution, introversion, emotional excitation, anxiety, and inactivity than MDMA and D-amphetamine. LSD also induced greater impairments in subjective ratings of concentration, sense of time, and speed of thinking compared with MDMA and D-amphetamine. MDMA produced greater ratings of good drug effects, liking, high, and ego dissolution compared with D-amphetamine. D-Amphetamine increased ratings of activity and concentration compared with LSD. MDMA but not LSD or D-amphetamine increased plasma concentrations of oxytocin. None of the substances altered plasma concentrations of brain-derived neurotrophic factor. These results indicate clearly distinct acute effects of LSD, MDMA, and D-amphetamine and may assist the dose-finding in substance-assisted psychotherapy research.",2020,LSD induced significantly higher ratings on the 5 Dimensions of Altered States of Consciousness scale and Mystical Experience Questionnaire than MDMA and D-amphetamine.,"['healthy subjects', '28 healthy subjects']","['3,4-methylenedioxymethamphetamine', 'LSD, MDMA, and D-amphetamine', 'LSD', 'MDMA', 'placebo', 'Lysergic acid diethylamide (LSD', 'D-amphetamine, and D-amphetamine', 'D-amphetamine']","['hemodynamic effects, body temperature, and pupil size, indicating equivalent autonomic responses', 'blood pressure', 'subjective ratings of concentration, sense of time, and speed of thinking', 'ratings of activity and concentration', 'plasma concentrations of oxytocin', 'subjective drug effects, ego dissolution, introversion, emotional excitation, anxiety, and inactivity than MDMA and D-amphetamine', 'LSD and MDMA increased heart rate', 'Consciousness scale and Mystical Experience Questionnaire', 'ratings of good drug effects, liking, high, and ego dissolution']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0115471', 'cui_str': 'MDMA'}, {'cui': 'C0024334', 'cui_str': 'LSD'}, {'cui': 'C0011812', 'cui_str': 'dexamfetamine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0886414', 'cui_str': 'Body temperature'}, {'cui': 'C0034121', 'cui_str': 'Pupil'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0728867', 'cui_str': 'Drug action (finding)'}, {'cui': 'C0013712', 'cui_str': 'Ego'}, {'cui': 'C0021924', 'cui_str': 'Introversion'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0115471', 'cui_str': 'MDMA'}, {'cui': 'C0011812', 'cui_str': 'dexamfetamine'}, {'cui': 'C0024334', 'cui_str': 'LSD'}, {'cui': 'C0039231', 'cui_str': 'Tachycardia'}, {'cui': 'C0234421', 'cui_str': 'Consciousness'}, {'cui': 'C0222045'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]",28.0,0.0410698,LSD induced significantly higher ratings on the 5 Dimensions of Altered States of Consciousness scale and Mystical Experience Questionnaire than MDMA and D-amphetamine.,"[{'ForeName': 'Friederike', 'Initials': 'F', 'LastName': 'Holze', 'Affiliation': 'Department of Biomedicine and Department of Clinical Research, Division of Clinical Pharmacology and Toxicology, University Hospital Basel, University of Basel, Basel, 4056, Switzerland.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Vizeli', 'Affiliation': 'Department of Biomedicine and Department of Clinical Research, Division of Clinical Pharmacology and Toxicology, University Hospital Basel, University of Basel, Basel, 4056, Switzerland.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Müller', 'Affiliation': 'Psychiatric University Hospital (UPK), University of Basel, Basel, 4012, Switzerland.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Ley', 'Affiliation': 'Department of Biomedicine and Department of Clinical Research, Division of Clinical Pharmacology and Toxicology, University Hospital Basel, University of Basel, Basel, 4056, Switzerland.'}, {'ForeName': 'Raoul', 'Initials': 'R', 'LastName': 'Duerig', 'Affiliation': 'Department of Biomedicine and Department of Clinical Research, Division of Clinical Pharmacology and Toxicology, University Hospital Basel, University of Basel, Basel, 4056, Switzerland.'}, {'ForeName': 'Nimmy', 'Initials': 'N', 'LastName': 'Varghese', 'Affiliation': 'Psychiatric University Hospital (UPK), University of Basel, Basel, 4012, Switzerland.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Eckert', 'Affiliation': 'Psychiatric University Hospital (UPK), University of Basel, Basel, 4012, Switzerland.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Borgwardt', 'Affiliation': 'Psychiatric University Hospital (UPK), University of Basel, Basel, 4012, Switzerland.'}, {'ForeName': 'Matthias E', 'Initials': 'ME', 'LastName': 'Liechti', 'Affiliation': 'Department of Biomedicine and Department of Clinical Research, Division of Clinical Pharmacology and Toxicology, University Hospital Basel, University of Basel, Basel, 4056, Switzerland. matthias.liechti@usb.ch.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0569-3'] 426,32118347,Comparable efficacy with similarly low risk of hypoglycaemia in patient- vs physician-managed basal insulin initiation and titration in insulin-naïve type 2 diabetic subjects: The Italian Titration Approach Study.,"AIMS People with uncontrolled type 2 diabetes (T2DM) often delay initiating and titrating basal insulin. Patient-managed titration may reduce such deferral. The Italian Titration Approach Study (ITAS) compared the efficacy and safety of insulin glargine 300 U/mL (Gla-300) initiation and titration using patient- (nurse-supported) or physician-management in insulin-naïve patients with uncontrolled T2DM. MATERIALS AND METHODS ITAS was a multicentre, phase IV, 24-week, open-label, randomized (1:1), parallel-group study. Insulin-naïve adults with T2DM for ≥1 year with poor metabolic control initiated Gla-300 after discontinuation of SU/glinides, and were randomized to self-titrate insulin dose (nurse-assisted) or have it done by the physician. The primary endpoint was change in HbA 1c . Secondary outcomes included hypoglycaemia incidence and rate, change in fasting self-monitored plasma glucose, patient-reported outcomes (PROs), and adverse events. RESULTS Three hundred and fifty five participants were included in the intention-to-treat population. At Week 24, HbA 1c reduction from baseline was non-inferior in patient- vs physician-managed arms [least squares mean (LSM) change (SE): -1.60% (0.06) vs -1.49% (0.06), respectively; LSM difference: -0.11% (95% CI: -0.26 to 0.04)]. The incidence and rates of hypoglycaemia were similarly low in both arms: relative risk of confirmed and/or severe nocturnal (00:00-05:59 hours) hypoglycaemia was 0.77 (95% CI: 0.27 to 2.18). No differences were observed for improvement in PROs. No safety concerns were reported. CONCLUSIONS In the T2DM insulin-naïve, SU/glinides discontinued population, patient-managed (nurse-assisted) titration of Gla-300 may be a suitable option as it provides improved glycaemic control with low risk of hypoglycaemia, similar to physician-managed titration.",2020,"At Week 24, HbA 1c reduction from baseline was non-inferior in patient- vs physician-managed arms","['355 participants were included in the intention-to-treat population', 'Insulin-naïve adults with T2DM for ≥1\u2009year with poor metabolic control initiated Gla-300 after discontinuation of SU/glinides', 'People with uncontrolled type 2 diabetes (T2DM) often delay initiating and titrating basal insulin', 'insulin-naïve type 2 diabetic subjects', 'naïve patients with uncontrolled T2DM']","['insulin glargine', 'Gla-300) initiation and titration using patient- (nurse-supported) or physician-management in insulin']","['incidence and rates of hypoglycaemia', 'hypoglycaemia incidence and rate, change in fasting self-monitored plasma glucose, patient-reported outcomes (PROs) and adverse events', 'PROs', 'hypoglycaemia', 'change in HbA 1c ']","[{'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0011860', 'cui_str': 'Diabetes Mellitus, Type 2'}, {'cui': 'C0205112', 'cui_str': 'Basal (qualifier value)'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation (observable entity)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0181904', 'cui_str': 'Monitor, device (physical object)'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma (procedure)'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}]",355.0,0.0960344,"At Week 24, HbA 1c reduction from baseline was non-inferior in patient- vs physician-managed arms","[{'ForeName': 'Riccardo C', 'Initials': 'RC', 'LastName': 'Bonadonna', 'Affiliation': 'Division of Endocrinology and Metabolic Diseases and Department of Medicine and Surgery, University of Parma and AOU of Parma Italy, Parma, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Giaccari', 'Affiliation': 'Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome and Università Cattolica del Sacro Cuore, Rome, Italy.'}, {'ForeName': 'Raffaella', 'Initials': 'R', 'LastName': 'Buzzetti', 'Affiliation': 'Sapienza University of Rome, Rome, Italy.'}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Perseghin', 'Affiliation': 'University of Milan Bicocca, Milan, Italy.'}, {'ForeName': 'Domenico', 'Initials': 'D', 'LastName': 'Cucinotta', 'Affiliation': 'University of Messina, Messina, Italy.'}, {'ForeName': 'Angelo', 'Initials': 'A', 'LastName': 'Avogaro', 'Affiliation': 'University of Padua, Padova, Italy.'}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Aimaretti', 'Affiliation': 'University of the Eastern Piedmont, Vercelli, Italy.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Larosa', 'Affiliation': 'Sanofi, Milan, Italy.'}, {'ForeName': 'Carmine G', 'Initials': 'CG', 'LastName': 'Fanelli', 'Affiliation': 'Section of Endocrinology and Metabolism, Department of Medicine, Perugia University Medical School, Perugia, Italy.'}, {'ForeName': 'Geremia B', 'Initials': 'GB', 'LastName': 'Bolli', 'Affiliation': 'Section of Endocrinology and Metabolism, Department of Medicine, Perugia University Medical School, Perugia, Italy.'}]",Diabetes/metabolism research and reviews,['10.1002/dmrr.3304'] 427,31206400,Effects of the DASH Diet and Sodium Intake on Bloating: Results From the DASH-Sodium Trial.,"INTRODUCTION Bloating is one of the most common gastrointestinal complaints. Evidence has linked fiber and sodium to bloating; however, randomized trials examining these diet components are lacking. Here, we used a randomized trial to examine the effects of the high-fiber DASH diet and dietary sodium intake on abdominal bloating. We hypothesized that both the high-fiber DASH diet and higher sodium intake would increase bloating. METHODS The DASH-Sodium trial (1998-1999) randomized healthy adults to a high-fiber (32 g/d) DASH or low-fiber (11 g/d) Western diet (control). On their assigned diet, participants ate 3 sodium levels (50, 100, and 150 mmol/d at 2100 kcal) in 30-day periods in random order, with 5-day breaks between each period. The participants reported the presence of bloating at baseline and after each feeding period. Statistical analyses included log-binomial models to evaluate the risk of bloating. RESULTS Of 412 participants (mean age 48 years; 57% women; 57% black), 36.7% reported bloating at baseline. Regardless of the diet, high sodium intake increased the risk of bloating (risk ratio = 1.27; 95% confidence interval: 1.06-1.52; P = 0.01). The high-fiber DASH diet also increased the risk of bloating over all sodium levels (risk ratio = 1.41; 95% confidence interval: 1.22-1.64; P < 0.001). The effect of high-fiber DASH on bloating was greater in men than in women (P for interaction = 0.001). DISCUSSION Higher dietary sodium increased bloating, as did the high-fiber DASH diet. Although healthful high-fiber diets may increase bloating, these effects may be partially mitigated by decreasing dietary sodium intake. Future research is needed to explore mechanisms by which sodium intake and diet can influence bloating.",2019,"The effect of high-fiber DASH on bloating was greater in men than in women (P for interaction = 0.001). ","['1998-1999) randomized healthy adults to a high-fiber (32 g/d) DASH or low-fiber', 'Of 412 participants (mean age 48 years; 57% women; 57% black']","['DASH-Sodium trial', 'healthful high-fiber diets', 'DASH Diet and Sodium Intake', 'high-fiber DASH diet and dietary sodium intake']","['risk of bloating', 'bloating', 'presence of bloating', 'Bloating', 'abdominal bloating']","[{'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0225326', 'cui_str': 'Fiber'}, {'cui': 'C2711872', 'cui_str': '32G'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}]","[{'cui': 'C3541959', 'cui_str': 'Sodium supplement (substance)'}, {'cui': 'C0301568', 'cui_str': 'High residue diet (finding)'}, {'cui': 'C4053458', 'cui_str': 'Dietary Approaches To Stop Hypertension Diet'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0225326', 'cui_str': 'Fiber'}, {'cui': 'C0425433', 'cui_str': 'Dietary sodium intake (observable entity)'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C1291077', 'cui_str': 'Abdomen feels bloated'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}]",,0.0212397,"The effect of high-fiber DASH on bloating was greater in men than in women (P for interaction = 0.001). ","[{'ForeName': 'Allison W', 'Initials': 'AW', 'LastName': 'Peng', 'Affiliation': 'The Johns Hopkins University School of Medicine, The Johns Hopkins Bloomberg School of Public Health, and The Welch Center for Prevention, Epidemiology and Clinical Research, Baltimore, Maryland, USA.'}, {'ForeName': 'Stephen P', 'Initials': 'SP', 'LastName': 'Juraschek', 'Affiliation': 'Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Lawrence J', 'Initials': 'LJ', 'LastName': 'Appel', 'Affiliation': 'The Johns Hopkins University School of Medicine, The Johns Hopkins Bloomberg School of Public Health, and The Welch Center for Prevention, Epidemiology and Clinical Research, Baltimore, Maryland, USA.'}, {'ForeName': 'Edgar R', 'Initials': 'ER', 'LastName': 'Miller', 'Affiliation': 'The Johns Hopkins University School of Medicine, The Johns Hopkins Bloomberg School of Public Health, and The Welch Center for Prevention, Epidemiology and Clinical Research, Baltimore, Maryland, USA.'}, {'ForeName': 'Noel T', 'Initials': 'NT', 'LastName': 'Mueller', 'Affiliation': 'The Johns Hopkins University School of Medicine, The Johns Hopkins Bloomberg School of Public Health, and The Welch Center for Prevention, Epidemiology and Clinical Research, Baltimore, Maryland, USA.'}]",The American journal of gastroenterology,['10.14309/ajg.0000000000000283'] 428,32246743,Rivaroxaban for treatment of pediatric venous thromboembolism. An Einstein-Jr phase 3 dose-exposure-response evaluation.,"BACKGROUND Recently, the randomized EINSTEIN-Jr study showed similar efficacy and safety for rivaroxaban and standard anticoagulation for treatment of pediatric venous thromboembolism (VTE). The rivaroxaban dosing strategy was established based on phase 1 and 2 data in children and through pharmacokinetic (PK) modeling. METHODS Rivaroxaban treatment with tablets or the newly developed granules-for-oral suspension formulation was bodyweight-adjusted and administered once-daily, twice-daily, or thrice-daily for children with bodyweights of ≥30, ≥12 to <30, and <12 kg, respectively. Previously, these regimens were confirmed for children weighing ≥20 kg but only predicted in those <20 kg. Based on sparse blood sampling, the daily area under the plasma concentration-time curve [AUC (0-24)ss ] and trough [C trough,ss ] and maximum [C max,ss ] steady-state plasma concentrations were derived using population PK modeling. Exposure-response graphs were generated to evaluate the potential relationship of individual PK parameters with recurrent VTE, repeat imaging outcomes, and bleeding or adverse events. A taste-and-texture questionnaire was collected for suspension-recipients. RESULTS Of the 335 children (aged 0-17 years) allocated to rivaroxaban, 316 (94.3%) were evaluable for PK analyses. Rivaroxaban exposures were within the adult exposure range. No clustering was observed for any of the PK parameters with efficacy, bleeding, or adverse event outcomes. Results were similar for the tablet and suspension formulation. Acceptability and palatability of the suspension were favorable. DISCUSSION Based on this analysis and the recently documented similar efficacy and safety of rivaroxaban compared with standard anticoagulation, we conclude that bodyweight-adjusted pediatric rivaroxaban regimens with either tablets or suspension are validated and provide for appropriate treatment of children with VTE.",2020,"No clustering was observed for any of the PK parameters with efficacy, bleeding, or adverse event outcomes.","['pediatric venous thromboembolism', 'children with VTE', 'pediatric venous thromboembolism (VTE', '335 children (aged 0-17 years) allocated to']","['Rivaroxaban', 'rivaroxaban']","['Acceptability and palatability', 'individual PK parameters with recurrent VTE, repeat imaging outcomes, and bleeding or adverse events', 'plasma concentration-time curve [AUC (0-24)ss ] and trough [C trough,ss ] and maximum [C max,ss ] steady-state plasma concentrations', 'PK parameters with efficacy, bleeding, or adverse event outcomes']","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C1861172', 'cui_str': 'Thromboembolism, Venous'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0630906', 'cui_str': 'vinyltriethoxysilane'}, {'cui': 'C4709307', 'cui_str': '335'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C1739768', 'cui_str': 'rivaroxaban'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0630906', 'cui_str': 'vinyltriethoxysilane'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0444506', 'cui_str': 'Trough'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0205361', 'cui_str': 'Steady'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",335.0,0.0324861,"No clustering was observed for any of the PK parameters with efficacy, bleeding, or adverse event outcomes.","[{'ForeName': 'Guy', 'Initials': 'G', 'LastName': 'Young', 'Affiliation': ""Children's Hospital Los Angeles, University of Southern California Keck School of Medicine, Los Angeles, CA, USA.""}, {'ForeName': 'Anthonie W A', 'Initials': 'AWA', 'LastName': 'Lensing', 'Affiliation': 'Bayer AG, Wuppertal, Germany.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Monagle', 'Affiliation': ""Department of Clinical Haematology, Royal Children's Hospital, Haematology Research Murdoch Children's Research Institute, Parkville, Vic., Australia.""}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Male', 'Affiliation': 'Department of Paediatrics, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Kirstin', 'Initials': 'K', 'LastName': 'Thelen', 'Affiliation': 'Bayer AG, Wuppertal, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Willmann', 'Affiliation': 'Bayer AG, Wuppertal, Germany.'}, {'ForeName': 'Joseph S', 'Initials': 'JS', 'LastName': 'Palumbo', 'Affiliation': ""Cancer and Blood Diseases Institute, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.""}, {'ForeName': 'Riten', 'Initials': 'R', 'LastName': 'Kumar', 'Affiliation': ""Nationwide Children's Hospital, The Ohio State University, Columbus, OH, USA.""}, {'ForeName': 'Ildar', 'Initials': 'I', 'LastName': 'Nurmeev', 'Affiliation': 'Kazan State Medical University, Kazan, Russia.'}, {'ForeName': 'Kerry', 'Initials': 'K', 'LastName': 'Hege', 'Affiliation': 'Riley Hospital For Children at IU Health, Indianapolis, IN, USA.'}, {'ForeName': 'Fanny', 'Initials': 'F', 'LastName': 'Bajolle', 'Affiliation': 'M3C-Necker Enfants malades, Université Paris Descartes, Sorbonne Paris Cité, Paris, France.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Connor', 'Affiliation': ""The Noah's Ark Children's Hospital for Wales, Cardiff, UK.""}, {'ForeName': 'Hélène L', 'Initials': 'HL', 'LastName': 'Hooimeijer', 'Affiliation': ""Department of Hematology and Oncology, Beatrix Children's Hospital, University Medical Center Groningen, Groningen, The Netherlands.""}, {'ForeName': 'Marcela', 'Initials': 'M', 'LastName': 'Torres', 'Affiliation': ""Department of Hematology and Oncology, Cook Children's Medical Center, Fort Worth, TX, USA.""}, {'ForeName': 'Anthony K C', 'Initials': 'AKC', 'LastName': 'Chan', 'Affiliation': ""McMaster Children's Hospital, Hamilton, ON, Canada.""}, {'ForeName': 'Gili', 'Initials': 'G', 'LastName': 'Kenet', 'Affiliation': 'Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Holzhauer', 'Affiliation': 'Department of Pediatric Hematology and Oncology, Charité University Medicine, Berlin, Germany.'}, {'ForeName': 'Amparo', 'Initials': 'A', 'LastName': 'Santamaría', 'Affiliation': ""Hemostasis and Thrombosis Unit, Department of Hematology, University Hospital Vall d'Hebron, Barcelona, Spain.""}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Amedro', 'Affiliation': 'Paediatric and Congenital Cardiology Department, M3C Regional Reference Centre, Montpellier University Hospital, PhyMedExp, INSERM, CNRS, Montpellier, France.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Beyer-Westendorf', 'Affiliation': 'Division of Haematology and Haemostaseology, Department of Medicine I, Department of Haematology, University Hospital ""Carl Gustav Carus"" Dresden, King\'s Thrombosis Service, King\'s College London, London, UK.'}, {'ForeName': 'Ida', 'Initials': 'I', 'LastName': 'Martinelli', 'Affiliation': ""A. Bianchi Bonomi Hemophilia and Thrombosis Center, Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico, Milano, Italy.""}, {'ForeName': 'M Patricia', 'Initials': 'MP', 'LastName': 'Massicotte', 'Affiliation': 'Department of Paediatrics, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'William T', 'Initials': 'WT', 'LastName': 'Smith', 'Affiliation': 'Bayer U.S., LLC, Whippany, NJ, USA.'}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Berkowitz', 'Affiliation': 'Bayer U.S., LLC, Whippany, NJ, USA.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Schmidt', 'Affiliation': 'Department of Pharmaceutics, Center for Pharmacometrics and Systems Pharmacology, University of Florida, OR, USA.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Price', 'Affiliation': 'Division of Pediatric Hematology/Oncology, Department of Pediatrics, Dalhousie University, IWK Health Centre, Halifax, NS, Canada.'}, {'ForeName': 'Martin H', 'Initials': 'MH', 'LastName': 'Prins', 'Affiliation': 'Department of Clinical Epidemiology and Medical Technology Assessment, Maastricht University Medical Center, Maastricht, The Netherlands.'}, {'ForeName': 'Dagmar', 'Initials': 'D', 'LastName': 'Kubitza', 'Affiliation': 'Bayer AG, Wuppertal, Germany.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of thrombosis and haemostasis : JTH,['10.1111/jth.14813'] 429,32226019,Bright light therapy for depressive symptoms in hospitalized cardiac patients: A randomized controlled pilot trial.,"Depression is common among cardiac patients and associated with adverse cardiovascular outcomes. Bright light therapy has emerged as a promising treatment for depressive symptoms, however it has not yet been investigated in this population. We conducted a double-blind, randomized, placebo-controlled pilot trial to assess the feasibility of a larger-scale trial testing bright light therapy for depressive symptoms in cardiac patients. Patients hospitalized for an acute coronary syndrome or undergoing cardiac surgery were randomized to either bright light (10,000 lux) or dim light placebo (500 lux) lamps for 30 minutes each day over 4 weeks, beginning in-hospital. Depression was quantified using the Patient Health Questionnaire 9 (PHQ-9) and Depression Anxiety and Stress Scales (DASS-21). The Short-Form Health Survey 36 (SF-36) was used to measure quality of life. A total of 175 patients were screened and 15 were randomized (8 treatment, 7 placebo) (8.6%) over 10 months. Despite protocol amendments which broadened the inclusion criteria, the trial was terminated early for infeasibility based on the rate of enrollment (1-2 participants/month), with 39.5% of the target sample (38 participants) enrolled. Future trials should take into account the timing of the onset of depressive symptoms in these patients, and consider a less conservative approach to eligibility as well as ways to increase the acceptability of bright light therapy in hospitalized cardiac patients. Once enrolled, our findings suggest that most participants will adhere to the assigned treatment and complete follow-up.",2020,"A total of 175 patients were screened and 15 were randomized (8 treatment, 7 placebo) (8.6%) over 10 months.","['Patients hospitalized for an acute coronary syndrome or undergoing cardiac surgery', 'hospitalized cardiac patients', 'A total of 175 patients were screened and 15 were randomized (8 treatment, 7', 'cardiac patients']","['bright light therapy', 'placebo', 'Bright light therapy', 'bright light (10,000 lux) or dim light placebo']","['depressive symptoms', 'Patient Health Questionnaire 9 (PHQ-9) and Depression Anxiety and Stress Scales (DASS-21', 'Depression', 'quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0948089', 'cui_str': 'Acute Coronary Syndrome'}, {'cui': 'C0524727', 'cui_str': 'Surgery, Cardiac'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4517605', 'cui_str': '175'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0423899', 'cui_str': 'Gifted (observable entity)'}, {'cui': 'C0031765', 'cui_str': 'Photoradiation Therapy'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332264', 'cui_str': 'Light (weight) (qualifier value)'}, {'cui': 'C0560137', 'cui_str': 'lux (qualifier value)'}]","[{'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0222045'}, {'cui': 'C0034380'}]",175.0,0.586791,"A total of 175 patients were screened and 15 were randomized (8 treatment, 7 placebo) (8.6%) over 10 months.","[{'ForeName': 'Mark J', 'Initials': 'MJ', 'LastName': 'Eisenberg', 'Affiliation': 'Center for Clinical Epidemiology, Jewish General Hospital, Lady Davis Institute, Montreal, QC, Canada.'}, {'ForeName': 'Bettina', 'Initials': 'B', 'LastName': 'Habib', 'Affiliation': 'Center for Clinical Epidemiology, Jewish General Hospital, Lady Davis Institute, Montreal, QC, Canada.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Alcaraz', 'Affiliation': 'Center for Clinical Epidemiology, Jewish General Hospital, Lady Davis Institute, Montreal, QC, Canada.'}, {'ForeName': 'Brett D', 'Initials': 'BD', 'LastName': 'Thombs', 'Affiliation': 'Center for Clinical Epidemiology, Jewish General Hospital, Lady Davis Institute, Montreal, QC, Canada.'}, {'ForeName': 'Kristian B', 'Initials': 'KB', 'LastName': 'Filion', 'Affiliation': 'Center for Clinical Epidemiology, Jewish General Hospital, Lady Davis Institute, Montreal, QC, Canada.'}]",PloS one,['10.1371/journal.pone.0230839'] 430,32124514,CALIBER: a phase II randomized feasibility trial of chemoablation with mitomycin-C vs surgical management in low-risk non-muscle-invasive bladder cancer.,"OBJECTIVES To evaluate the activity of intravesical mitomycin-C (MMC) to ablate recurrent low-risk non-muscle-invasive bladder cancer (NMIBC) and assess whether it may enable patients to avoid surgical intervention for treatment of recurrence. PATIENTS AND METHODS CALIBER is a phase II feasibility study. Participants were randomized (2:1) to treatment with four once-weekly MMC 40-mg intravesical instillations (chemoablation arm) or to surgical management. The surgical group was included to assess the feasibility of randomization. The primary endpoint was complete response to intravesical MMC in the chemoablation arm at 3 months, reported with exact 95% confidence intervals (CIs). Secondary endpoints included time to subsequent recurrence, summarized by Kaplan-Meier methods. RESULTS Between February 2015 and August 2017, 82 patients with visual diagnosis of recurrent low-risk NMIBC were enrolled from 24 UK hospitals (chemoablation, n = 54; surgical management, n =28). The median follow-up was 24 months. Complete response at 3 months was 37.0% (20/54; 95% CI 24.3-51.3) with chemoablation and 80.8% (21/26; 95% CI 60.6-93.4) with surgical management. Amongst patients with complete response at 3 months, a similar proportion was recurrence-free by 12 months in both groups (84%). Amongst those with residual disease at 3 months, the 12-month recurrence-free proportion was lower in the surgical management group (40.0%) than in the chemoablation group (84%). Recruitment stopped early as chemoablation did not meet the prespecified threshold of 45% complete responses at 3 months. CONCLUSION Intravesical chemoablation in low-risk NMIBC is feasible and safe, but did not demonstrate sufficient response in the present trial. After chemoablation there may be a reduction in recurrence rate, even in non-responders, that is greater than with surgery alone. Further research is required to investigate the role and optimal schedule of neoadjuvant intravesical chemotherapy prior to surgery for NMIBC.",2020,"Intravesical chemoablation in low risk NMIBC is feasible and safe, but did not demonstrate sufficient response in this trial.","['Between February 2015 and August 2017', 'low risk non-muscle invasive bladder cancer', '82 patients with visual diagnosis of recurrent low risk NMIBC were enrolled from 24 UK hospitals (54 chemoablation, 28 surgical management']","['intravesical mitomycin C (MMC', 'mitomycin', 'MMC 40mg intravesical instillations (chemoablation arm) or surgical management']","['recurrence rate', 'Complete response', 'time to subsequent recurrence, summarised by Kaplan-Meier methods', '12-month recurrence-free proportion', 'complete response to intravesical MMC', 'recurrence-free']","[{'cui': 'C3538919', 'cui_str': 'Low risk (qualifier value)'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C1827293', 'cui_str': 'Invasive bladder cancer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}]","[{'cui': 'C0442124', 'cui_str': 'Intravesical approach (qualifier value)'}, {'cui': 'C0002475', 'cui_str': 'Mitomycin'}, {'cui': 'C0021917', 'cui_str': 'Instillation, Bladder'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}]","[{'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0442124', 'cui_str': 'Intravesical approach (qualifier value)'}]",82.0,0.125464,"Intravesical chemoablation in low risk NMIBC is feasible and safe, but did not demonstrate sufficient response in this trial.","[{'ForeName': 'A Hugh', 'Initials': 'AH', 'LastName': 'Mostafid', 'Affiliation': 'Royal Surrey County Hospital NHS Foundation Trust, Guildford, UK.'}, {'ForeName': 'Nuria', 'Initials': 'N', 'LastName': 'Porta', 'Affiliation': 'Institute of Cancer Research, London, UK.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Cresswell', 'Affiliation': 'South Tees Hospitals NHS Foundation Trust, Middlesbrough, UK.'}, {'ForeName': 'Thomas R L', 'Initials': 'TRL', 'LastName': 'Griffiths', 'Affiliation': 'University Hospitals of Leicester NHS Trust, Leicester, UK.'}, {'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Kelly', 'Affiliation': 'University College London, London, UK.'}, {'ForeName': 'Steven R', 'Initials': 'SR', 'LastName': 'Penegar', 'Affiliation': 'Institute of Cancer Research, London, UK.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Davenport', 'Affiliation': 'Gloucestershire Hospitals NHS Foundation Trust, Cheltenham, UK.'}, {'ForeName': 'John S', 'Initials': 'JS', 'LastName': 'McGrath', 'Affiliation': 'Royal Devon and Exeter NHS Foundation Trust, Exeter, UK.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Campain', 'Affiliation': 'Royal Devon and Exeter NHS Foundation Trust, Exeter, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Cooke', 'Affiliation': 'Royal Wolverhampton Hospitals NHS Trust, Wolverhampton, UK.'}, {'ForeName': 'Shikohe', 'Initials': 'S', 'LastName': 'Masood', 'Affiliation': 'Medway NHS Foundation Trust, Gillingham, UK.'}, {'ForeName': 'Margaret A', 'Initials': 'MA', 'LastName': 'Knowles', 'Affiliation': 'University of Leeds, Leeds, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Feber', 'Affiliation': 'University College London, London, UK.'}, {'ForeName': 'Allen', 'Initials': 'A', 'LastName': 'Knight', 'Affiliation': 'Action Bladder Cancer UK, Gloucestershire, UK.'}, {'ForeName': 'James W F', 'Initials': 'JWF', 'LastName': 'Catto', 'Affiliation': 'University of Sheffield, Sheffield, UK.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Lewis', 'Affiliation': 'Institute of Cancer Research, London, UK.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Hall', 'Affiliation': 'Institute of Cancer Research, London, UK.'}]",BJU international,['10.1111/bju.15038'] 431,32214333,Electronic charts do not facilitate the recognition of patient hazards by advanced medical students: A randomized controlled study.,"Chart review is an important tool to identify patient hazards. Most advanced medical students perform poorly during chart review but can learn how to identify patient hazards context-independently. Many hospitals have implemented electronic health records, which enhance patient safety but also pose challenges. We investigated whether electronic charts impair advanced medical students' recognition of patient hazards compared with traditional paper charts. Fifth-year medical students were randomized into two equal groups. Both groups attended a lecture on patient hazards and a training session on handling electronic health records. One group reviewed an electronic chart with 12 standardized patient hazards and then reviewed another case in a paper chart; the other group reviewed the charts in reverse order. The two case scenarios (diabetes and gastrointestinal bleeding) were used as the first and second case equally often. After each case, the students were briefed about the patient safety hazards. In total, 78.5% of the students handed in their notes for evaluation. Two blinded raters independently assessed the number of patient hazards addressed in the students' notes. For the diabetes case, the students identified a median of 4.0 hazards [25%-75% quantiles (Q25-Q75): 2.0-5.5] in the electronic chart and 5.0 hazards (Q25-Q75: 3.0-6.75) in the paper chart (equivalence testing, p = 0.005). For the gastrointestinal bleeding case, the students identified a median of 5.0 hazards (Q25-Q75: 4.0-6.0) in the electronic chart and 5.0 hazards (Q25-Q75: 3.0-6.0) in the paper chart (equivalence testing, p < 0.001). We detected no improvement between the first case [median 5.0 (Q25-Q75: 3.0-6.0)] and second case [median, 5.0 (Q25-Q75: 3.0-6.0); p < 0.001, test for equivalence]. Electronic charts do not seem to facilitate advanced medical students' recognition of patient hazards during chart review and may impair expertise formation.",2020,Electronic charts do not seem to facilitate advanced medical students' recognition of patient hazards during chart review and may impair expertise formation.,"['advanced medical students', 'Fifth-year medical students']",[],[],"[{'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0038495', 'cui_str': 'Students, Medical'}, {'cui': 'C0205439', 'cui_str': 'Fifth (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]",[],[],,0.0199588,Electronic charts do not seem to facilitate advanced medical students' recognition of patient hazards during chart review and may impair expertise formation.,"[{'ForeName': 'Friederike', 'Initials': 'F', 'LastName': 'Holderried', 'Affiliation': 'Department of Anaesthesiology, University Hospital Tübingen, Tübingen, Baden-Württemberg, Germany.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Herrmann-Werner', 'Affiliation': 'Department of Internal Medicine VI, Psychosomatic Medicine, University Hospital Tübingen, Baden-Württemberg, Tübingen, Germany.'}, {'ForeName': 'Moritz', 'Initials': 'M', 'LastName': 'Mahling', 'Affiliation': 'Department of Diabetology, Endocrinology, Nephrology, Section of Nephrology and Hypertension, University Hospital Tübingen, Tübingen, Baden-Württemberg, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Holderried', 'Affiliation': 'Department of Quality Management, Medical and Business Development, University Hospital of Tübingen, Tübingen, Baden-Württemberg, Germany.'}, {'ForeName': 'Reimer', 'Initials': 'R', 'LastName': 'Riessen', 'Affiliation': 'Department of Internal Medicine VIII, Intensive Care Unit, University Hospital Tübingen, Tübingen, Baden-Württemberg, Germany.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Zipfel', 'Affiliation': 'Department of Internal Medicine VI, Psychosomatic Medicine, University Hospital Tübingen, Baden-Württemberg, Tübingen, Germany.'}, {'ForeName': 'Nora', 'Initials': 'N', 'LastName': 'Celebi', 'Affiliation': 'PHV Dialysis Center Waiblingen, Waiblingen, Germany.'}]",PloS one,['10.1371/journal.pone.0230522'] 432,31664343,Effect of Leap Motion-based 3D Immersive Virtual Reality Usage on Upper Extremity Function in Ischemic Stroke Patients.,"Immersive virtual reality (VR) is a technology that provides a more realistic environmental design and object tracking than ordinary VR. The aim of this study was to investigate the effectiveness of immersive VR on upper extremity function in patients with ischemic stroke. Sixty-five patients with ischemic stroke were included in this randomized, controlled, double-blind study. Patients were randomly divided into VR (n = 33) and control (n = 32) groups. The VR group received 60 minutes of the upper extremity immersive VR rehabilitation program and the control group received 45 minutes of conventional therapy and 15 minutes of a sham VR program. Rehabilitation consisted of 18 sessions of therapy, three days per week, for six weeks. The outcome measures were the Action Research Arm Test (ARAT), Functional Independence Measure (FIM), Fugl-Meyer Upper Extremity Scale (FMUE) and Performance Assessment of Self-Care Skills (PASS). In both the VR and control groups all parameters except the PASS improved over time. However independent t-test results showed that all of the FMUE, ARAT, FIM and PASS scores were significantly higher in the VR group compared with the control (p < 0.05). The minimal clinically important difference (MCID) scores of the FMUE and ARAT were higher than the cut-off MCID scores described in the literature in the VR group, whereas the FIM scores were below the cut-off MCID scores. All scores in the control group were below the cut-off scores. Immersive VR rehabilitation appeared to be effective in improving upper extremity function and self-care skills, but it did not improve functional independence.",2019,"Immersive VR rehabilitation appeared to be effective in improving upper extremity function and self-care skills, but it did not improve functional independence.","['patients with ischemic stroke', 'Sixty-five patients with ischemic stroke', 'Ischemic Stroke Patients']","['upper extremity immersive VR rehabilitation program and the control group received 45 minutes of conventional therapy and 15 minutes of a sham VR program', 'Leap Motion-based 3D Immersive Virtual Reality Usage', 'immersive VR', 'Immersive VR rehabilitation', 'Immersive virtual reality (VR']","['functional independence', 'upper extremity function and self-care skills', 'Action Research Arm Test (ARAT), Functional Independence Measure (FIM), Fugl-Meyer Upper Extremity Scale (FMUE) and Performance Assessment of Self-Care Skills (PASS', 'FMUE, ARAT, FIM and PASS scores', 'minimal clinically important difference (MCID) scores of the FMUE and ARAT', 'FIM scores']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C0450385', 'cui_str': '65 (qualifier value)'}]","[{'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1442463', 'cui_str': 'Forty-five minutes (qualifier value)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1442447', 'cui_str': 'Fifteen minutes (qualifier value)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0687704', 'cui_str': 'Motions (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0457083', 'cui_str': 'Usage (attribute)'}]","[{'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0036592', 'cui_str': 'Self Care'}, {'cui': 'C4720875', 'cui_str': 'Action research arm test'}, {'cui': 'C0451172', 'cui_str': 'Functional independence measure (assessment scale)'}, {'cui': 'C0222045'}, {'cui': 'C0549077', 'cui_str': 'Assessment of self care (procedure)'}, {'cui': 'C1264673', 'cui_str': 'Arbitrary rate'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C4277733', 'cui_str': 'Minimal Clinically Important Difference'}]",65.0,0.0115916,"Immersive VR rehabilitation appeared to be effective in improving upper extremity function and self-care skills, but it did not improve functional independence.","[{'ForeName': 'Muhammed Nur', 'Initials': 'MN', 'LastName': 'Ögün', 'Affiliation': 'Bolu Abant Izzet Baysal Universitesi; Nöroloji Anabilim Dalı, Bolu, Türkiye.'}, {'ForeName': 'Ramazan', 'Initials': 'R', 'LastName': 'Kurul', 'Affiliation': 'Bolu Abant Izzet Baysal Universitesi; Sağlık Bilimleri Fakültesi, Fizik Tedavi ve Rehabilitasyon Yüksekokulu, Bolu, Türkiye.'}, {'ForeName': 'Mustafa Fatih', 'Initials': 'MF', 'LastName': 'Yaşar', 'Affiliation': 'Bolu Abant Izzet Baysal Universitesi; Fizik Tedavi ve Rehabilitasyon Anabilim Dalı, Bolu, Türkiye.'}, {'ForeName': 'Sule Aydin', 'Initials': 'SA', 'LastName': 'Turkoglu', 'Affiliation': 'Bolu Abant Izzet Baysal Universitesi; Nöroloji Anabilim Dalı, Bolu, Türkiye.'}, {'ForeName': 'Şebnem', 'Initials': 'Ş', 'LastName': 'Avci', 'Affiliation': 'Bolu Abant Izzet Baysal Universitesi; Sağlık Bilimleri Fakültesi, Fizik Tedavi ve Rehabilitasyon Yüksekokulu, Bolu, Türkiye.'}, {'ForeName': 'Nebil', 'Initials': 'N', 'LastName': 'Yildiz', 'Affiliation': 'Bolu Abant Izzet Baysal Universitesi; Nöroloji Anabilim Dalı, Bolu, Türkiye.'}]",Arquivos de neuro-psiquiatria,['10.1590/0004-282X20190129'] 433,31712987,Preventing acute kidney injury and improving outcome in critically ill patients utilizing risk prediction score (PRAIOC-RISKS) study. A prospective controlled trial of AKI prevention.,"BACKGROUND Acute kidney injury (AKI) has significant impact on mortality and morbidity in critically ill patients. METHODS A prospective controlled interventional pilot study composed of observation and intervention arms was run at two different Intensive care unit (ICU) sites. A recently validated risk prediction score was used to predict the AKI in critically ill patients at high risk of developing AKI. All patients with established AKI at the time of recruitment were excluded from the study. A package of early preventive measures, including an early nephrology review was applied to high risk patients in the intervention arm to prevent AKI development. RESULTS We have recruited 108 patients at the intervention site and 98 patients at the observation site. The primary outcome measure was the AKI incidence. AKI incidence was significantly lower in the intervention arm than its incidence in the observation arm (11% vs 26%, p = 0.002). The median Time till recovery of AKI episodes was significantly lower in the intervention arm (3(1) vs. 5(2) days, p = 0.014) 0.30 day mortality was lower in the intervention arm, however, not statistically significant. CONCLUSION Our pilot study showed that it was feasible to apply a simple risk score to implement early preventive measures to high risk patients, consequently, mitigating the risk of AKI development and reducing the time till recovery of AKI episodes. Multicentre studies are needed to confirm this favourable effect.",2020,"AKI incidence was significantly lower in the intervention arm than its incidence in the observation arm (11% vs 26%, p = 0.002).","['All patients with established AKI at the time of recruitment were excluded from the study', 'critically ill patients at high risk of developing AKI', 'critically ill patients', 'critically ill patients utilizing risk prediction score (PRAIOC-RISKS) study', '108 patients at the intervention site and 98 patients at the observation site']",[],"['AKI incidence', 'median Time till recovery of AKI episodes', 'mortality and morbidity']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0443211', 'cui_str': 'Established (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0010340', 'cui_str': 'Critically Ill'}, {'cui': 'C0332167', 'cui_str': 'High risk of (contextual qualifier) (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C4517530', 'cui_str': 'One hundred and eight'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0302523', 'cui_str': 'Observation'}]",[],"[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}]",108.0,0.102574,"AKI incidence was significantly lower in the intervention arm than its incidence in the observation arm (11% vs 26%, p = 0.002).","[{'ForeName': 'Tarek Samy', 'Initials': 'TS', 'LastName': 'Abdelaziz', 'Affiliation': 'Department of Internal Medicine, KasrAlainy Hospitals, Cairo University Hospitals, Cairo, Egypt. taroukah5070@kasralainy.edu.eg.'}, {'ForeName': 'Ragai', 'Initials': 'R', 'LastName': 'Fouda', 'Affiliation': 'Medical ICU, KasrAlainy Hospitals, Cairo University Hospitals, Cairo, Egypt.'}, {'ForeName': 'Wessam M', 'Initials': 'WM', 'LastName': 'Hussin', 'Affiliation': 'Department of Internal Medicine, KasrAlainy Hospitals, Cairo University Hospitals, Cairo, Egypt.'}, {'ForeName': 'Mohamed S', 'Initials': 'MS', 'LastName': 'Elyamny', 'Affiliation': 'Department of Internal Medicine, KasrAlainy Hospitals, Cairo University Hospitals, Cairo, Egypt.'}, {'ForeName': 'Yasser M', 'Initials': 'YM', 'LastName': 'Abdelhamid', 'Affiliation': 'Department of Internal Medicine, KasrAlainy Hospitals, Cairo University Hospitals, Cairo, Egypt.'}]",Journal of nephrology,['10.1007/s40620-019-00671-6'] 434,32205642,"Optimal Timing of Feeding After Endoscopic Hemostasis in Patients With Peptic Ulcer Bleeding: A Randomized, Noninferiority Trial (CRIS KCT0001019).","OBJECTIVES The optimal duration of fasting after endoscopic hemostasis in patients with peptic ulcer bleeding has not yet been determined. We investigated the appropriate timing of feeding after endoscopic hemostasis in patients with high-risk peptic ulcer bleeding. METHODS This study was a randomized, single center, noninferiority trial. Between February 2014 and March 2019, consecutive patients with peptic ulcer bleeding were randomized to resume feeding either 24 or 48 hours after successful endoscopic hemostasis. A total of 209 eligible patients were included in the intention-to-treat analysis and 200 in the per-protocol (PP) analysis. The primary outcome measure was recurrent bleeding within 7 days of hemostasis. Noninferiority testing was performed in the PP population, and the noninferiority margin was set at 10%. Secondary outcomes included 30-day rebleeding and mortality, transfusion requirements, and length of hospital stay. RESULTS Recurrent bleeding rates at 7 days were 7.9% in the 24-hour group and 4.0% in the 48-hour group in the PP analysis; tests for noninferiority did not reach statistical significance (difference: 3.9%, 95% confidence interval [CI]: -2.7 to 10.5, P value for noninferiority = 0.034). The recurrent bleeding rates within 30 days were 10.9% and 4.0% in the 24- and 48-hour groups (difference: 6.9%, 95% CI: -0.5 to 14.2), and the 30-day mortality rates were 5.9% and 14.1%, respectively (difference: -8.2%, 95% CI: -16.5 to 0.1) in the PP analysis. The transfusion requirement and the length of hospital stay were similar between the 2 groups. DISCUSSION Early refeeding at 24 hours after endoscopic hemostasis is not noninferior to later refeeding at 48 hours for rebleeding in patients with high-risk peptic ulcer bleeding. Our results do not allow a recommendation of refeeding at 24 hours, rather than later refeeding in this population.",2020,Early refeeding at 24 hours after endoscopic hemostasis is not noninferior to later refeeding at 48 hours for rebleeding in patients with high-risk peptic ulcer bleeding.,"['209 eligible patients were included in the intention-to-treat analysis and 200 in the per-protocol (PP) analysis', 'patients with peptic ulcer bleeding', 'Between February 2014 and March 2019, consecutive patients with peptic ulcer bleeding', 'patients with high-risk peptic ulcer bleeding', 'Patients With Peptic Ulcer Bleeding']",[],"['transfusion requirement and the length of hospital stay', 'Recurrent bleeding rates', '30-day mortality rates', '30-day rebleeding and mortality, transfusion requirements, and length of hospital stay', 'recurrent bleeding within 7 days of hemostasis', 'recurrent bleeding rates']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0030920', 'cui_str': 'Gastroduodenal Ulcer'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}]",[],"[{'cui': 'C0199960', 'cui_str': 'Transfusion - action (qualifier value)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0205848', 'cui_str': 'Death Rate'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0740166', 'cui_str': 'Haemostasis'}]",209.0,0.218447,Early refeeding at 24 hours after endoscopic hemostasis is not noninferior to later refeeding at 48 hours for rebleeding in patients with high-risk peptic ulcer bleeding.,"[{'ForeName': 'Eun Jeong', 'Initials': 'EJ', 'LastName': 'Gong', 'Affiliation': 'Department of Internal Medicine, Gangneung Asan Hoapital, University of Ulsan College of Medicine, Gangneung, Korea.'}, {'ForeName': 'Sang Jin', 'Initials': 'SJ', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, Gangneung Asan Hoapital, University of Ulsan College of Medicine, Gangneung, Korea.'}, {'ForeName': 'Baek Gyu', 'Initials': 'BG', 'LastName': 'Jun', 'Affiliation': 'Department of Internal Medicine, Gangneung Asan Hoapital, University of Ulsan College of Medicine, Gangneung, Korea.'}, {'ForeName': 'Hyun Il', 'Initials': 'HI', 'LastName': 'Seo', 'Affiliation': 'Department of Internal Medicine, Gangneung Asan Hoapital, University of Ulsan College of Medicine, Gangneung, Korea.'}, {'ForeName': 'Jong Kyu', 'Initials': 'JK', 'LastName': 'Park', 'Affiliation': 'Department of Internal Medicine, Gangneung Asan Hoapital, University of Ulsan College of Medicine, Gangneung, Korea.'}, {'ForeName': 'Koon Hee', 'Initials': 'KH', 'LastName': 'Han', 'Affiliation': 'Department of Internal Medicine, Gangneung Asan Hoapital, University of Ulsan College of Medicine, Gangneung, Korea.'}, {'ForeName': 'Young Don', 'Initials': 'YD', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Gangneung Asan Hoapital, University of Ulsan College of Medicine, Gangneung, Korea.'}, {'ForeName': 'Woo Jin', 'Initials': 'WJ', 'LastName': 'Jeong', 'Affiliation': 'Department of Internal Medicine, Gangneung Asan Hoapital, University of Ulsan College of Medicine, Gangneung, Korea.'}, {'ForeName': 'Gab Jin', 'Initials': 'GJ', 'LastName': 'Cheon', 'Affiliation': 'Department of Internal Medicine, Gangneung Asan Hoapital, University of Ulsan College of Medicine, Gangneung, Korea.'}, {'ForeName': 'Seo Young', 'Initials': 'SY', 'LastName': 'Park', 'Affiliation': 'Department of Clinical Epidemiology and Biostatistics, Asan Medical Center, Seoul, Korea.'}]",The American journal of gastroenterology,['10.14309/ajg.0000000000000584'] 435,32222056,Improving pediatric endocrinology trainees' knowledge about insulin pumps and continuous glucose monitors with online spaced education: Technology Knowledge Optimization in T1D (TeKnO T1D).,"OBJECTIVE We explored the impact of TeKnO T1D, an online, case-based, spaced education curriculum about insulin pump and continuous glucose monitor (CGM) use in pediatric type 1 diabetes management. METHODS Pediatric endocrinology fellows (n = 64) were randomized to receive an educational curriculum focused on either insulin pumps or CGMs. Fellows received interactive questions twice weekly via email or mobile app. Median time to completion was 76.5 days. The primary outcome was change in knowledge as measured by performance on multiple-choice questions (MCQ) from the pre-test to the post-test. RESULTS Forty-eight of 64 (75%) learners completed the curriculum and assessments. The pump group improved from 35.0 ± 15% on the pre-test MCQs to 61.1 ± 17% on the post-test, a 12.2 absolute percentage point greater improvement on pump-specific items than the CGM group (P = .03). The CGM group improved from 30.3 ± 15% on the pre-test MCQs to 61.4 ± 21% on the post-test, a 28.7 absolute percentage point greater improvement on CGM-specific items than the pump group (P < .001). Both groups were more likely to report an appropriate level of understanding of their respective technologies after completing the corresponding curriculum. In thematic analysis of qualitative data, fellows indicated that knowledge gains led to improved patient care. There was universal agreement about enjoyment and effectiveness of the curricula. CONCLUSIONS TeKnO T1D proved to be an engaging, effective way to improve endocrinology fellows' knowledge and confidence about insulin pumps and CGM use in the management of pediatric type 1 diabetes.",2020,"T1D proved to be an engaging, effective way to improve endocrinology fellows' knowledge and confidence about insulin pumps and CGM use in the management of pediatric type 1 diabetes.","['Pediatric endocrinology fellows (n\xa0=\xa064', 'T1D', 'pediatric type 1 diabetes management', 'Forty-eight of 64 (75']","['CGM', 'insulin pump and continuous glucose monitor (CGM', 'educational curriculum focused on either insulin pumps or CGMs', 'interactive questions twice weekly via email or mobile app', 'Insulin Pumps and Continuous Glucose Monitors with Online Spaced Education']","['Median time to completion', 'CGM-specific items', 'pump-specific items', 'change in knowledge as measured by performance on multiple-choice questions (MCQ']","[{'cui': 'C1658521', 'cui_str': 'Pediatric endocrinology'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0441729', 'cui_str': 'Type 1 (qualifier value)'}, {'cui': 'C4319608', 'cui_str': 'Forty-eight'}]","[{'cui': 'C1140609', 'cui_str': 'Insulin pump'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0181904', 'cui_str': 'Monitor, device (physical object)'}, {'cui': 'C0220815', 'cui_str': 'curriculum'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C0556985', 'cui_str': 'Two times a week'}, {'cui': 'C0013849', 'cui_str': 'Email'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}]",64.0,0.0403653,"T1D proved to be an engaging, effective way to improve endocrinology fellows' knowledge and confidence about insulin pumps and CGM use in the management of pediatric type 1 diabetes.","[{'ForeName': 'Brynn E', 'Initials': 'BE', 'LastName': 'Marks', 'Affiliation': ""Division of Endocrinology, Boston Children's Hospital, Boston, Massachusetts, USA.""}, {'ForeName': 'Gretchen', 'Initials': 'G', 'LastName': 'Waldman', 'Affiliation': ""Division of Endocrinology, Boston Children's Hospital, Boston, Massachusetts, USA.""}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Reardon', 'Affiliation': ""Division of Endocrinology, Boston Children's Hospital, Boston, Massachusetts, USA.""}, {'ForeName': 'Shannon', 'Initials': 'S', 'LastName': 'Terrio', 'Affiliation': ""Division of Endocrinology, Boston Children's Hospital, Boston, Massachusetts, USA.""}, {'ForeName': 'Anshul', 'Initials': 'A', 'LastName': 'Kumar', 'Affiliation': 'MGH Institute of Health Professions, Charlestown, Massachusetts, USA.'}, {'ForeName': 'Diane E J', 'Initials': 'DEJ', 'LastName': 'Stafford', 'Affiliation': ""Division of Endocrinology, Boston Children's Hospital, Boston, Massachusetts, USA.""}, {'ForeName': 'Katharine C', 'Initials': 'KC', 'LastName': 'Garvey', 'Affiliation': ""Division of Endocrinology, Boston Children's Hospital, Boston, Massachusetts, USA.""}, {'ForeName': 'Joseph I', 'Initials': 'JI', 'LastName': 'Wolfsdorf', 'Affiliation': ""Division of Endocrinology, Boston Children's Hospital, Boston, Massachusetts, USA.""}]",Pediatric diabetes,['10.1111/pedi.13010'] 436,32214373,Precision nicotine metabolism-informed care for smoking cessation in Crohn's disease: A pilot study.,"INTRODUCTION Smoking is a strong risk factor for disease severity in Crohn's disease (CD) and cessation improves outcomes. The nicotine metabolite ratio (NMR) predicts cessation success with pharmacotherapy: varenicline doubles cessation over nicotine replacement therapy (NRT) for ""normal"", but not ""slow"" metabolizers. Varenicline side effects are heightened in slow metabolizers. Methods using NMR to optimize cessation pharmacotherapy have not been evaluated in CD. AIMS We aim to determine the prevalence of smoking in a CD population and then assess these smokers' attitudes toward a personalized metabolism-informed care (MIC) approach to cessation. METHODS In this observational study, we surveyed 1098 patients visiting an inflammatory bowel disease center about their smoking history. We then evaluated a subgroup of individuals with CD (n = 32) who participated in a randomized controlled trial of smoking cessation using MIC versus usual care. For MIC, medication selection was informed by the NMR (normal ≥0.31 vs. slow <0.31). The primary outcomes were intervention satisfaction and match rates between NMR and medication choice. RESULTS The baseline prevalence of smoking in our CD population was 13%. Intervention participants reported high rates of satisfaction (85%) and chose a medication that matched their NMR result more often in the MIC group (100% vs. 64%, p = 0.01). Six of 16 (37.5%) patients prescribed varenicline discontinued due to side effects. CONCLUSION MIC produced high rates of satisfaction and matching between NMR and medication in CD patients, supporting patient acceptance and feasibility of precision smoking cessation in this population. To reduce smoking in CD, therapies such as MIC are needed to maximize efficacy and minimize side effects.",2020,"The nicotine metabolite ratio (NMR) predicts cessation success with pharmacotherapy: varenicline doubles cessation over nicotine replacement therapy (NRT) for ""normal"", but not ""slow"" metabolizers.","[""Crohn's disease"", '1098 patients visiting an inflammatory bowel disease center about their smoking history', 'subgroup of individuals with CD (n = 32) who participated in a randomized controlled trial of smoking cessation using MIC versus usual care']","['Varenicline', 'nicotine metabolite ratio (NMR', 'nicotine replacement therapy (NRT', 'varenicline', 'Precision nicotine metabolism-informed care']","['intervention satisfaction and match rates between NMR and medication choice', 'high rates of satisfaction']","[{'cui': 'C0156147', 'cui_str': 'Colitis, Granulomatous'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0021390', 'cui_str': 'Inflammatory Bowel Diseases'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0019665', 'cui_str': 'historical aspects'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C0427978', 'cui_str': 'Minimum Inhibitory Concentration'}]","[{'cui': 'C1569608', 'cui_str': 'varenicline'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C1278444', 'cui_str': 'Nicotine replacement therapy'}, {'cui': 'C0025520', 'cui_str': 'metabolism'}, {'cui': 'C0700287', 'cui_str': 'Informing (procedure)'}]","[{'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]",1098.0,0.030592,"The nicotine metabolite ratio (NMR) predicts cessation success with pharmacotherapy: varenicline doubles cessation over nicotine replacement therapy (NRT) for ""normal"", but not ""slow"" metabolizers.","[{'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Scoville', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, Vanderbilt University Medical Center, Nashville, Tennessee, United States of America.'}, {'ForeName': 'Hilary A', 'Initials': 'HA', 'LastName': 'Tindle', 'Affiliation': 'Department of Medicine, Vanderbilt University Medical Center, Nashville, Tennessee, United States of America.'}, {'ForeName': 'Quinn S', 'Initials': 'QS', 'LastName': 'Wells', 'Affiliation': 'Division of Cardiology, Department of Medicine, Vanderbilt University Medical Center, Nashville, Tennessee, United States of America.'}, {'ForeName': 'Shannon C', 'Initials': 'SC', 'LastName': 'Peyton', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, Vanderbilt University Medical Center, Nashville, Tennessee, United States of America.'}, {'ForeName': 'Shelly', 'Initials': 'S', 'LastName': 'Gurwara', 'Affiliation': 'Division of Gastroenterology, Wake Forest School of Medicine, Winston-Salem, North Carolina, United States of America.'}, {'ForeName': 'Stephanie O', 'Initials': 'SO', 'LastName': 'Pointer', 'Affiliation': 'Division of Gastroenterology, The Ohio State University Wexner Medical Center, Columbus, Ohio, United States of America.'}, {'ForeName': 'Sara N', 'Initials': 'SN', 'LastName': 'Horst', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, Vanderbilt University Medical Center, Nashville, Tennessee, United States of America.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Schwartz', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, Vanderbilt University Medical Center, Nashville, Tennessee, United States of America.'}, {'ForeName': 'Dawn W', 'Initials': 'DW', 'LastName': 'Adams', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, Vanderbilt University Medical Center, Nashville, Tennessee, United States of America.'}, {'ForeName': 'Matthew S', 'Initials': 'MS', 'LastName': 'Freiberg', 'Affiliation': 'Geriatric Research Education and Clinical Centers (GRECC), Veterans Affairs Tennessee Valley Healthcare System, Nashville, Tennessee, United States of America.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Gatskie', 'Affiliation': 'Department of Pediatrics, Vanderbilt University Medical Center, Nashville, Tennessee, United States of America.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'King', 'Affiliation': 'Department of Medicine, Vanderbilt University Medical Center, Nashville, Tennessee, United States of America.'}, {'ForeName': 'Lesa R', 'Initials': 'LR', 'LastName': 'Abney', 'Affiliation': 'Department of Medicine, Vanderbilt University Medical Center, Nashville, Tennessee, United States of America.'}, {'ForeName': 'Dawn B', 'Initials': 'DB', 'LastName': 'Beaulieu', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, Vanderbilt University Medical Center, Nashville, Tennessee, United States of America.'}]",PloS one,['10.1371/journal.pone.0230656'] 437,30852173,The Effect of Text Messaging on Medication Adherence After Outpatient Knee Arthroscopy: A Randomized Controlled Trial.,"PURPOSE The purpose of this project was to examine if text message reminders can increase postoperative adherence to treatment with acetaminophen among outpatients undergoing arthroscopic knee surgery. DESIGN A nonblinded randomized control trial. METHODS In this study, 187 patients were randomized to either an intervention group (text message reminders) or a control group (no text message reminders). On the fourth postoperative day, all patients received an electronic questionnaire concerning (1) adherence to treatment with acetaminophen (main outcome), (2) pain intensity, and (3) unscheduled health care contacts. FINDINGS Data were available from 134 patients (intervention group, n = 70; control group, n = 64). No significant differences between groups were found regarding the median number of missed acetaminophen doses (1 vs 2.5; P = .06), pain intensity at rest and during walking, or the number of unscheduled health care contacts (7 vs 4; P = .35). CONCLUSIONS A nonsignificant trend toward an increased medication adherence of acetaminophen was found.",2019,"No significant differences between groups were found regarding the median number of missed acetaminophen doses (1 vs 2.5; P = .06), pain intensity at rest and during walking, or the number of unscheduled health care contacts (7 vs 4; P = .35). ","['134 patients (intervention group, n\xa0=\xa070; control group, n = 64', 'After Outpatient Knee Arthroscopy', '187 patients', 'outpatients undergoing arthroscopic knee surgery']","['Text Messaging', 'intervention group (text message reminders) or a control group (no text message reminders', 'acetaminophen', 'electronic questionnaire concerning (1) adherence to treatment with acetaminophen (main outcome), (2) pain intensity, and (3) unscheduled health care contacts']","['Medication Adherence', 'medication adherence', 'pain intensity at rest and during walking, or the number of unscheduled health care contacts', 'median number of missed acetaminophen doses', 'postoperative adherence']","[{'cui': 'C4517565', 'cui_str': 'One hundred and thirty-four'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0187970', 'cui_str': 'Diagnostic arthroscopy of knee'}, {'cui': 'C4517618', 'cui_str': '187 (qualifier value)'}, {'cui': 'C0187769', 'cui_str': 'Operative procedure on knee'}]","[{'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C4281784', 'cui_str': 'Electronics'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205225', 'cui_str': 'Principal (qualifier value)'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}]","[{'cui': 'C2364172', 'cui_str': 'Medication Adherence'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0443144', 'cui_str': 'At rest (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}]",187.0,0.0957448,"No significant differences between groups were found regarding the median number of missed acetaminophen doses (1 vs 2.5; P = .06), pain intensity at rest and during walking, or the number of unscheduled health care contacts (7 vs 4; P = .35). ","[{'ForeName': 'Lone D', 'Initials': 'LD', 'LastName': 'Brix', 'Affiliation': ''}, {'ForeName': 'Karen T', 'Initials': 'KT', 'LastName': 'Bjørnholdt', 'Affiliation': ''}, {'ForeName': 'Theis M', 'Initials': 'TM', 'LastName': 'Thillemann', 'Affiliation': ''}, {'ForeName': 'Lone', 'Initials': 'L', 'LastName': 'Nikolajsen', 'Affiliation': ''}]",Journal of perianesthesia nursing : official journal of the American Society of PeriAnesthesia Nurses,['10.1016/j.jopan.2018.11.011'] 438,30853329,Effects of Vibration and Cold Application on Pain and Anxiety During Intravenous Catheterization.,"PURPOSE To determine the effects of vibration and cold gel pack application on pain and anxiety levels of patients undergoing intravenous (IV) catheterization. DESIGN A randomized controlled, pretest and post-test experimental study. METHODS Catheterization was performed 60 seconds before the IV catheterization procedure was started by applying vibration and cold gel pack to patients in the experimental group. Patients in the control group underwent catheterization using standard procedures. FINDINGS The mean pain scores of patients in the experimental group were lower than those of the patients in the control group. Intragroup analysis demonstrated that the mean scores obtained from the state anxiety and trait anxiety inventories after the study were not significantly different from those obtained before the study. CONCLUSIONS Vibration and cold gel pack application is suggested to relive pain during IV catheterization in adults.",2019,The mean pain scores of patients in the experimental group were lower than those of the patients in the control group.,"['patients undergoing intravenous (IV) catheterization', 'adults']","['vibration and cold gel pack application', 'Vibration and Cold Application', 'Vibration and cold gel pack application']","['pain and anxiety levels', 'Pain and Anxiety', 'state anxiety and trait anxiety inventories', 'mean pain scores']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0007430', 'cui_str': 'Catheterization'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0459800', 'cui_str': 'Vibration'}, {'cui': 'C0009443', 'cui_str': 'Common Cold'}, {'cui': 'C0017243', 'cui_str': 'Gel (basic dose form)'}, {'cui': 'C1968515', 'cui_str': 'Pack (physical object)'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety (observable entity)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}]",,0.0264679,The mean pain scores of patients in the experimental group were lower than those of the patients in the control group.,"[{'ForeName': 'Sevgi', 'Initials': 'S', 'LastName': 'Pakiş Çetin', 'Affiliation': ''}, {'ForeName': 'Kıvan', 'Initials': 'K', 'LastName': 'Çevik', 'Affiliation': ''}]",Journal of perianesthesia nursing : official journal of the American Society of PeriAnesthesia Nurses,['10.1016/j.jopan.2018.12.005'] 439,31039250,Featured Article: Behavior Interventions Addressing Obesity in Rural Settings: The E-FLIP for Kids Trial.,"OBJECTIVE To assess the effectiveness of behavioral parent-only (PO) and family-based (FB) interventions on child weight, dietary intake, glycated hemoglobin, and quality of life in rural settings. METHODS This study was a three-armed, randomized controlled trial. Participants were children (age 8-12 years) with overweight or obesity and their parents. A FB (n = 88), a PO (n = 78) and a health education condition (HEC) (n = 83) each included 20 group contacts over 1 year. Assessment and treatment contacts occurred at Cooperative Extension Service offices. The main outcome was change in child body mass index z-score (BMIz) from baseline to year 2. RESULTS Parents in all conditions reported high treatment satisfaction (mean of 3.5 or higher on a 4-point scale). A linear mixed model analysis of change in child BMIz from baseline to year 1 and year 2 found that there were no significant group by time differences in child BMIz (year 2 change in BMIz for FB = -0.03 [-0.1, 0.04], PO = -0.01 [-0.08, 0.06], and HEC = -0.09 [-0.15, -0.02]). While mean attendance across conditions was satisfactory during months 1-4 (69%), it dropped during the maintenance phase (42%). High attendance for the PO intervention was related to greater changes in child BMIz (p < .02). Numerous barriers to participation were reported. CONCLUSION Many barriers exist that inhibit regular attendance at in-person contacts for many families. Innovative delivery strategies are needed that balance treatment intensity with feasibility and acceptability to families and providers to facilitate broad dissemination in underserved rural settings.ClinicalTrials.gov Identifier: NCT01820338.",2019,"RESULTS Parents in all conditions reported high treatment satisfaction (mean of 3.5 or higher on a 4-point scale).","['Rural Settings', 'Participants were children (age 8-12 years) with overweight or obesity and their parents']","['behavioral parent-only (PO) and family-based (FB) interventions', 'health education condition (HEC) (n\u2009']","['treatment satisfaction', 'child BMIz', 'child body mass index z-score (BMIz', 'child weight, dietary intake, glycated hemoglobin, and quality of life']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}]","[{'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0018701'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0017853', 'cui_str': 'Hemoglobin, Glycosylated'}, {'cui': 'C0034380'}]",,0.153368,"RESULTS Parents in all conditions reported high treatment satisfaction (mean of 3.5 or higher on a 4-point scale).","[{'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Janicke', 'Affiliation': 'University of Florida.'}, {'ForeName': 'Crystal S', 'Initials': 'CS', 'LastName': 'Lim', 'Affiliation': 'University of Mississippi Medical Center.'}, {'ForeName': 'Michael G', 'Initials': 'MG', 'LastName': 'Perri', 'Affiliation': 'University of Florida.'}, {'ForeName': 'Anne E', 'Initials': 'AE', 'LastName': 'Mathews', 'Affiliation': 'University of Florida.'}, {'ForeName': 'Linda B', 'Initials': 'LB', 'LastName': 'Bobroff', 'Affiliation': 'University of Florida.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Gurka', 'Affiliation': 'University of Florida.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Parish', 'Affiliation': 'Duke University.'}, {'ForeName': 'Babette A', 'Initials': 'BA', 'LastName': 'Brumback', 'Affiliation': 'University of Florida.'}, {'ForeName': 'Marilyn', 'Initials': 'M', 'LastName': 'Dumont-Driscoll', 'Affiliation': 'University of Florida.'}, {'ForeName': 'Janet H', 'Initials': 'JH', 'LastName': 'Silverstein', 'Affiliation': 'University of Florida.'}]",Journal of pediatric psychology,['10.1093/jpepsy/jsz029'] 440,30840084,Randomized Trial of a Positive Psychology Intervention for Adolescents With Type 1 Diabetes.,"OBJECTIVE To evaluate the effects of a positive psychology intervention for adolescents with type 1 diabetes (T1D) on adherence, glycemic control, and quality of life. METHODS Adolescents with T1D (n = 120) and their caregivers were randomized to either an Education (EDU) (n = 60) or Positive Affect (PA) intervention (n = 60). Adolescents in the PA group received the intervention reminders (gratitude, self-affirmation, parental affirmation, and small gifts) via text messages or phone calls over 8 weeks. Questionnaires were completed by adolescents and caregivers and clinical data (glucometer and HbA1c) were collected at baseline 3 and 6 months. Data were analyzed using generalized linear modeling. RESULTS After adjusting for covariates, adolescents in the PA group demonstrated significant improvement in quality of life at 3 months, compared to the EDU group, but this was not sustained at 6 months. Similarly, the PA group showed a significant decrease in disengagement coping at 3 months but not at 6 months. There was no significant intervention effect on blood glucose monitoring, but the odds of clinically significantly improvement (checking at least one more time/day) were about twice as high in the PA group as the EDU group. No significant effects were found for glycemic control. CONCLUSIONS A positive psychology intervention had initial significant, positive effects on coping and quality of life in adolescents with T1D. A more intensive or longer-lasting intervention may be needed to sustain these effects and to improve adherence and glycemic control.",2019,"After adjusting for covariates, adolescents in the PA group demonstrated significant improvement in quality of life at 3 months, compared to the EDU group, but this was not sustained at 6 months.","['adolescents with T1D', 'Adolescents With Type 1 Diabetes', 'Adolescents with T1D (n\u2009=\u2009120) and their caregivers', 'adolescents with type 1 diabetes (T1D']","['Education (EDU) (n\u2009=\u200960) or Positive Affect (PA) intervention', 'positive psychology intervention', 'intervention reminders (gratitude, self-affirmation, parental affirmation, and small gifts) via text messages or phone calls over 8\u2009weeks', 'Positive Psychology Intervention']","['disengagement coping', 'coping and quality of life', 'glycemic control', 'blood glucose monitoring', 'quality of life', 'adherence, glycemic control, and quality of life']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}]","[{'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}, {'cui': 'C0033909', 'cui_str': 'Psychology'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C1136188', 'cui_str': 'Gifts'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C0034380'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C0181904', 'cui_str': 'Monitor, device (physical object)'}]",,0.0449269,"After adjusting for covariates, adolescents in the PA group demonstrated significant improvement in quality of life at 3 months, compared to the EDU group, but this was not sustained at 6 months.","[{'ForeName': 'Sarah S', 'Initials': 'SS', 'LastName': 'Jaser', 'Affiliation': 'Department of Pediatrics, Vanderbilt University Medical Center.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Whittemore', 'Affiliation': 'School of Nursing, Yale University.'}, {'ForeName': 'Leena', 'Initials': 'L', 'LastName': 'Choi', 'Affiliation': 'Department of Biostatistics, Vanderbilt University Medical Center.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Nwosu', 'Affiliation': 'Department of Biostatistics, Vanderbilt University Medical Center.'}, {'ForeName': 'William E', 'Initials': 'WE', 'LastName': 'Russell', 'Affiliation': 'Department of Pediatrics, Vanderbilt University Medical Center.'}]",Journal of pediatric psychology,['10.1093/jpepsy/jsz006'] 441,32238341,Testing a Real-Time Tenofovir Urine Adherence Assay for Monitoring and Providing Feedback to Preexposure Prophylaxis in Kenya (PUMA): Protocol for a Pilot Randomized Controlled Trial.,"BACKGROUND The worldwide expansion of preexposure prophylaxis (PrEP) with oral tenofovir-disoproxil-fumarate/emtricitabine will be critical to ending the HIV epidemic. However, maintaining daily adherence to PrEP can be difficult, and the accuracy of self-reported adherence is often limited by social desirability bias. Pharmacologic adherence monitoring (measuring drug levels in a biomatrix) has been critical to interpreting PrEP trials, but testing usually requires expensive equipment and skilled personnel. We have recently developed a point-of-care (POC) immunoassay to measure tenofovir in urine, allowing real-time adherence monitoring for the first time. OBJECTIVE The goal of this study is to examine a point-of-care adherence metric in PrEP to support and increase adherence via a randomized controlled trial. METHODS The paper describes the protocol for a pilot randomized controlled trial to test the acceptability, feasibility, and impact on long-term adherence of implementing a POC urine test to provide real-time adherence feedback among women on PrEP. Eligible women (n=100) will be HIV-negative, ≥18 years old, and recruited from a clinic in Kenya that provides PrEP. Participants will be randomized 1:1 to the intervention of providing real-time feedback via the assay versus standard of care adherence counseling. Acceptability by participants will be assessed by a quantitative survey, as well as by qualitative data collected via in-depth interviews (n=20) and focus group discussions (n=4 groups, 5-10 women each). Feasibility will be assessed by the proportion of women retained in the study, the mean number of missed visits, the proportion of planned urine assessments completed, and messages delivered, while in-depth interviews with providers (n=8) will explore the ease of administering the urine test. Tenofovir levels in hair will serve as long-term adherence metrics. A linear mixed-effects model will estimate the effect of the intervention versus standard of care on logarithmically transformed levels of tenofovir in hair. RESULTS This study has been funded by the National Institute of Health, approved by the Kenya Medical Research Institute Institutional Review Board, and will commence in June 2020. CONCLUSIONS A novel urine assay to measure and deliver information on adherence to PrEP in real-time will be tested for the first time in this trial planned among women on PrEP in Kenya. Study findings will inform a larger-scale trial assessing the impact of real-time adherence monitoring/feedback on HIV prevention. Improving adherence to PrEP will have long-term implications for efforts to end the HIV epidemic worldwide. TRIAL REGISTRATION ClinicalTrials.gov NCT03935464; https://clinicaltrials.gov/ct2/show/NCT03935464. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID) PRR1-10.2196/15029.",2020,Participants will be randomized 1:1 to the intervention of providing real-time feedback via the assay versus standard of care adherence counseling.,"['Eligible women (n=100) will be HIV-negative, ≥18 years old, and recruited from a clinic in Kenya that provides PrEP', 'Kenya (PUMA', 'in hair', 'women on PrEP', 'women on PrEP in Kenya']","['intervention of providing real-time feedback via the assay versus standard of care adherence counseling', 'Tenofovir', 'tenofovir', 'oral tenofovir-disoproxil-fumarate/emtricitabine']",[],"[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0481430', 'cui_str': 'HIV negative'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0022558', 'cui_str': 'Kenya'}, {'cui': 'C1070653', 'cui_str': 'Genus Puma'}, {'cui': 'C0018494', 'cui_str': 'Hair structure'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0005507', 'cui_str': 'Bioassay'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0384228', 'cui_str': 'Tenofovir'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C1099776', 'cui_str': 'Tenofovir disoproxil fumarate'}, {'cui': 'C0909839', 'cui_str': 'emtricitabine'}]",[],,0.233658,Participants will be randomized 1:1 to the intervention of providing real-time feedback via the assay versus standard of care adherence counseling.,"[{'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Drain', 'Affiliation': 'University of Washington, Seattle, WA, United States.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Ngure', 'Affiliation': 'Jomo Kenyatta University of Agriculture and Technology, Nairobi, Kenya.'}, {'ForeName': 'Nelly', 'Initials': 'N', 'LastName': 'Mugo', 'Affiliation': 'Kenya Medical Research Institute, Nairobi, Kenya.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Spinelli', 'Affiliation': 'University of California, San Francisco, CA, United States.'}, {'ForeName': 'Purba', 'Initials': 'P', 'LastName': 'Chatterjee', 'Affiliation': 'University of California, San Francisco, CA, United States.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Bacchetti', 'Affiliation': 'University of California, San Francisco, CA, United States.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Glidden', 'Affiliation': 'University of California, San Francisco, CA, United States.'}, {'ForeName': 'Jared', 'Initials': 'J', 'LastName': 'Baeten', 'Affiliation': 'University of Washington, Seattle, WA, United States.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Gandhi', 'Affiliation': 'University of California, San Francisco, CA, United States.'}]",JMIR research protocols,['10.2196/15029'] 442,32238343,"A Smartphone App (mDASHNa-CC) to Support Healthy Diet and Hypertension Control for Chinese Canadian Seniors: Protocol for Design, Usability and Feasibility Testing.","BACKGROUND This proposed study aims to translate the Dietary Approach to Stop Hypertension with Sodium (Na) Reduction for Chinese Canadians (DASHNa-CC), a classroom-based, antihypertensive, dietary educational intervention, to an innovative smartphone app (mDASHNa-CC). This study will enable Chinese Canadian seniors to access antihypertensive dietary interventions anytime, regardless of where they are. It is hypothesized that senior Chinese Canadians will be satisfied with their experiences using the mDASHNa-CC app and that the use of this app could lead to a decrease in their blood pressure and improvement in their health-related quality of life. OBJECTIVE The goal of this study is to design and test the usability and feasibility of a smartphone-based dietary educational app to support a healthy diet and hypertension control for Chinese Canadian seniors. METHODS A mixed-method two-phase design will be used. The study will be conducted in a Chinese immigrant community in Toronto, Ontario, Canada. Chinese Canadian seniors, who are at least 65 years old, self-identified as Chinese, living in Canada, and with elevated blood pressure, will be recruited. In Phase I, we will design and test the usability of the app using a user-centered approach. In Phase II, we will test the feasibility of the app, including implementation (primary outcomes of accrual and attrition rates, technical issues, acceptability of the app, and adherence to the intervention) and preliminary effectiveness (secondary outcomes of systolic and diastolic blood pressure, weight, waist circumference, health-related quality of life, and health service utilization), using a pilot, two-group, randomized controlled trial with a sample size of 60 participants in a Chinese Canadian community. RESULTS The study is supported by the Startup Research Grant from Nipissing University, Canada. The research ethics application is under review by a university research ethics review board. CONCLUSIONS The study results will make several contributions to the existing literature, including illustrating the rigorous design and testing of smartphone app technology for hypertension self-management in the community, exploring an approach to incorporating traditional medicine into chronic illness management in minority communities and promoting equal access to current technology among minority immigrant senior groups. TRIAL REGISTRATION Clinicaltrials.gov NCT03988894; https://clinicaltrials.gov/ct2/show/NCT03988894. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID) PRR1-10.2196/15545.",2020,"It is hypothesized that senior Chinese Canadians will be satisfied with their experiences using the mDASHNa-CC app and that the use of this app could lead to a decrease in their blood pressure and improvement in their health-related quality of life. ","['Chinese Canadian Seniors', 'minority immigrant senior groups', 'Chinese Canadian seniors, who are at least 65 years old, self-identified as Chinese, living in Canada, and with elevated blood pressure, will be recruited', 'Chinese immigrant community in Toronto, Ontario, Canada', '60 participants in a Chinese Canadian community', 'Chinese Canadian seniors']","['Smartphone App (mDASHNa-CC', 'smartphone-based dietary educational app to support a healthy diet and hypertension control', 'smartphone app technology']","['systolic and diastolic blood pressure, weight, waist circumference, health-related quality of life, and health service utilization', 'blood pressure', 'accrual and attrition rates, technical issues, acceptability of the app, and adherence']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C0026192', 'cui_str': 'Minority Groups'}, {'cui': 'C0282163', 'cui_str': 'Immigrant'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0029040', 'cui_str': 'Ontario'}]","[{'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0452415', 'cui_str': 'Healthy diet'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0039421', 'cui_str': 'Technology'}]","[{'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0030672', 'cui_str': 'Health Care Utilization'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0004277', 'cui_str': 'Dental Attrition'}, {'cui': 'C0449851', 'cui_str': 'Technique'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}]",,0.0927861,"It is hypothesized that senior Chinese Canadians will be satisfied with their experiences using the mDASHNa-CC app and that the use of this app could lead to a decrease in their blood pressure and improvement in their health-related quality of life. ","[{'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Zou', 'Affiliation': 'School of Nursing, Nipissing University, Toronto, ON, Canada.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Stinson', 'Affiliation': 'Lawrence Bloomberg Faculty of Nursing, University of Toronto, Hospital for Sick Children, Toronto, ON, Canada.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Parry', 'Affiliation': 'Lawrence Bloomberg Faculty of Nursing, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Cindy-Lee', 'Initials': 'CL', 'LastName': 'Dennis', 'Affiliation': 'Lawrence Bloomberg Faculty of Nursing and Department of Psychiatry, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Yeqin', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'School of Nursing, Wenzhou Medical University, Wenzhou, China.'}, {'ForeName': 'Zhongqiu', 'Initials': 'Z', 'LastName': 'Lu', 'Affiliation': 'School of Nursing, Wenzhou Medical University, Wenzhou, China.'}]",JMIR research protocols,['10.2196/15545'] 443,31944617,Who benefits from the intervention? Correlates of successful BMI reduction in the Texas Childhood Obesity Demonstration Project (TX-CORD).,"BACKGROUND Many childhood obesity intervention studies report mean outcomes but do not explore the variation in responses and the characteristics of those who respond well. OBJECTIVE To identify child and family characteristics associated with improvement in the primary outcome, %BMI p95 , of the Texas Childhood Obesity Research Demonstration project (TX-CORD). METHODS The 12-month TX-CORD secondary prevention study randomized 549 children, ages 2 to 12 years, with BMI ≥85th percentile to the intensive intervention vs. the comparison program, with measurements at baseline, 3-, and 12-months. A growth mixture model was used to identify mutually exclusive latent %BMI p95 trajectories. Latent class regression tested associations between baseline characteristics and latent class membership. RESULTS A 2-class solution emerged after accounting for the effect of intervention randomization. Latent Class 1 participants (86% of sample) were characterized by mild-to-moderate obesity and demonstrated a significantly greater response to the intensive intervention between 0 and 3 months (slope-on-group = -0.931, p = 0.03). A rebound between 3 and 12 months was not significantly different between arms. Latent Class 2 participants (14%), who had severe obesity, demonstrated no difference in response between intervention groups. Characteristics associated with Class 1 membership included younger age (2-5 years vs. 6-12 years: OR 3.70, p = .035) and lower maternal BMI category (< 35 kg/m 2 vs. ≥ 35 kg/m 2 : OR 7.14, p < .0001). CONCLUSIONS The optimal target population for the intensive intervention are children who have milder obesity, are younger, and do not have a mother with severe obesity. Children with severe obesity may require different approaches.",2020,A rebound between 3 and 12 months was not significantly different between arms.,"['Children with severe obesity', '549 children, ages 2 to 12 years, with BMI ≥85th percentile to the intensive intervention vs. the comparison program, with measurements at baseline, 3-, and 12-months', 'children who have milder obesity, are younger, and do not have a mother with severe obesity']",[],"['lower maternal BMI category', 'response to the intensive intervention']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0028756', 'cui_str': 'Obesity, Severe'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1264641', 'cui_str': 'Percentile'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}]",[],"[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}]",549.0,0.0796709,A rebound between 3 and 12 months was not significantly different between arms.,"[{'ForeName': 'Sarah E', 'Initials': 'SE', 'LastName': 'Barlow', 'Affiliation': 'Baylor College of Medicine, Houston, Texas.'}, {'ForeName': 'Casey', 'Initials': 'C', 'LastName': 'Durand', 'Affiliation': 'University of Texas Health Science Center at Houston (UTHealth) School of Public Health, Houston, Texas.'}, {'ForeName': 'Meliha', 'Initials': 'M', 'LastName': 'Salahuddin', 'Affiliation': 'Michael and Susan Dell Center for Healthy Living, University of Texas Health Science Center at Houston (UTHealth) School of Public Health, Austin Regional Campus, Austin, Texas.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Pont', 'Affiliation': 'University of Texas at Austin Dell Medical School, Austin, Texas.'}, {'ForeName': 'Nancy F', 'Initials': 'NF', 'LastName': 'Butte', 'Affiliation': ""USDA/ARS Children's Nutrition Research Center, Baylor College of Medicine, Houston, Texas.""}, {'ForeName': 'Deanna M', 'Initials': 'DM', 'LastName': 'Hoelscher', 'Affiliation': 'Michael and Susan Dell Center for Healthy Living, University of Texas Health Science Center at Houston (UTHealth) School of Public Health, Austin Regional Campus, Austin, Texas.'}]",Pediatric obesity,['10.1111/ijpo.12609'] 444,31181564,A randomized trial of an NMDA receptor antagonist for reversing corticosteroid effects on the human hippocampus.,"Preclinical and clinical research indicates that excess corticosteroid is associated with adverse effects on the hippocampus. Animal model data suggest that N-methyl-D-aspartate (NMDA) receptor antagonists may block corticosteroid effect on the hippocampus. This translational clinical trial investigated the effect of memantine vs. placebo on hippocampal subfield volume in humans receiving chronic corticosteroid therapy. Men and women (N = 46) receiving chronic prescription corticosteroid therapy were randomized to memantine or placebo in a double-blind, crossover design (two 24-week treatment periods, separated by a 4-week washout) for 52 weeks. Structural magnetic resonance imaging was obtained at baseline and after each treatment. Data were analyzed using repeated measures analysis of variance. Mean corticosteroid dose was 7.69 ± 6.41 mg/day and mean duration 4.90 ± 5.61 years. Controlling for baseline volumes, the left DG/CA3 region was significantly larger following memantine than placebo (p = .011). The findings suggest that an NMDA receptor antagonist attenuates corticosteroid effect in the same hippocampal subfields in humans as in animal models. This finding has both mechanistic and clinical implications. Attenuation of the effect of corticosteroids on the human DG/CA3 region implicates the NMDA receptor in human hippocampal volume losses with corticosteroids. In addition, by suggesting a drug class that may, at least in part, block the effects of corticosteroids on the human DG/CA3 subfield, these results may have clinical relevance for people receiving prescription corticosteroids, as well as to those with cortisol elevations due to medical or psychiatric conditions.",2019,"Controlling for baseline volumes, the left DG/CA3 region was significantly larger following memantine than placebo (p = .011).","['Men and women (N\u2009=\u200946) receiving chronic prescription corticosteroid therapy', 'humans receiving chronic corticosteroid therapy']","['NMDA receptor antagonist', 'placebo', 'memantine or placebo', 'memantine vs. placebo', 'memantine', 'corticosteroids']","['left DG/CA3 region', 'hippocampal subfield volume']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0033080', 'cui_str': 'Prescriptions'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0598695', 'cui_str': 'NMDA receptor antagonist'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0025242', 'cui_str': 'Memantine'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}]","[{'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}]",,0.420896,"Controlling for baseline volumes, the left DG/CA3 region was significantly larger following memantine than placebo (p = .011).","[{'ForeName': 'E Sherwood', 'Initials': 'ES', 'LastName': 'Brown', 'Affiliation': 'Department of Psychiatry, The University of Texas Southwestern Medical Center, Dallas, TX, 75390, USA. Sherwood.Brown@UTSouthwestern.edu.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Kulikova', 'Affiliation': 'Department of Psychiatry, The University of Texas Southwestern Medical Center, Dallas, TX, 75390, USA.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Van Enkevort', 'Affiliation': 'Department of Psychiatry, The University of Texas Southwestern Medical Center, Dallas, TX, 75390, USA.'}, {'ForeName': 'Alyson', 'Initials': 'A', 'LastName': 'Nakamura', 'Affiliation': 'Department of Psychiatry, The University of Texas Southwestern Medical Center, Dallas, TX, 75390, USA.'}, {'ForeName': 'Elena I', 'Initials': 'EI', 'LastName': 'Ivleva', 'Affiliation': 'Department of Psychiatry, The University of Texas Southwestern Medical Center, Dallas, TX, 75390, USA.'}, {'ForeName': 'Nicholas J', 'Initials': 'NJ', 'LastName': 'Tustison', 'Affiliation': 'Department of Neurobiology and Behavior, Center for the Neurobiology of Learning and Memory, University of California at Irvine, Irvine, CA, 92697, USA.'}, {'ForeName': 'Jared', 'Initials': 'J', 'LastName': 'Roberts', 'Affiliation': 'Department of Neurobiology and Behavior, Center for the Neurobiology of Learning and Memory, University of California at Irvine, Irvine, CA, 92697, USA.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Yassa', 'Affiliation': 'Department of Neurobiology and Behavior, Center for the Neurobiology of Learning and Memory, University of California at Irvine, Irvine, CA, 92697, USA.'}, {'ForeName': 'Changho', 'Initials': 'C', 'LastName': 'Choi', 'Affiliation': 'Departments of Radiology and the Advanced Imaging Research Center, The University of Texas Southwestern Medical Center, Dallas, TX, 75390, USA.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Frol', 'Affiliation': 'Department of Psychiatry, The University of Texas Southwestern Medical Center, Dallas, TX, 75390, USA.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Khan', 'Affiliation': 'Department of Internal Medicine, The University of Texas Southwestern Medical Center, Dallas, TX, 75390, USA.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Vazquez', 'Affiliation': 'Department of Internal Medicine, The University of Texas Southwestern Medical Center, Dallas, TX, 75390, USA.'}, {'ForeName': 'Traci', 'Initials': 'T', 'LastName': 'Holmes', 'Affiliation': 'Department of Psychiatry, The University of Texas Southwestern Medical Center, Dallas, TX, 75390, USA.'}, {'ForeName': 'Kendra', 'Initials': 'K', 'LastName': 'Malone', 'Affiliation': 'Department of Psychiatry, The University of Texas Southwestern Medical Center, Dallas, TX, 75390, USA.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0430-8'] 445,31221698,Aerobic Fitness and Adherence to Guideline-Recommended Minimum Physical Activity Among Ambulatory Patients With Type 2 Diabetes Mellitus.,"OBJECTIVE Lifestyle intervention remains the cornerstone of management of type 2 diabetes mellitus (T2DM). However, adherence to physical activity (PA) recommendations and the impact of that adherence on cardiorespiratory fitness in this population have been poorly described. We sought to investigate adherence to PA recommendations and its association with cardiorespiratory fitness in a population of patients with T2DM. RESEARCH DESIGN AND METHODS A cross-sectional analysis of baseline data from a randomized clinical trial (NCT00424762) was performed. A total of 150 individuals with medically treated T2DM and atherosclerotic cardiovascular disease (ASCVD) or risk factors for ASCVD were recruited from outpatient clinics at a single academic medical center. All individuals underwent a graded maximal exercise treadmill test to exhaustion with breath-by-breath gas exchange analysis to determine VO 2peak . PA was estimated using a structured 7-Day Physical Activity Recall interview. RESULTS Participants had a mean ± SD age of 54.9 ± 9.0 years; 41% were women, 40% were black, and 21% were Hispanic. The mean HbA 1c was 7.7 ± 1.8% and the mean BMI, 34.5 ± 7.2 kg/m 2 . A total of 72% had hypertension, 73% had hyperlipidemia, and 35% had prevalent ASCVD. The mean ± SD reported daily PA was 34.3 ± 4 kcal/kg, only 7% above a sedentary state; 47% of the cohort failed to achieve the minimum recommended PA. Mean ± SD VO 2peak was 27.4 ± 6.5 mL/kg fat-free mass/min (18.8 ± 5.0 mL/kg/min). CONCLUSIONS On average, patients with T2DM who have or are at risk for ASCVD report low levels of PA and have low measured cardiopulmonary fitness. This underscores the importance of continued efforts to close this therapeutic gap.",2019,"Mean ± SD VO 2peak was 27.4 ± 6.5 mL/kg fat-free mass/min (18.8 ± 5.0 mL/kg/min). ","['Ambulatory Patients With Type 2 Diabetes Mellitus', 'A total of 72% had hypertension, 73% had hyperlipidemia, and 35% had prevalent ASCVD', 'patients with T2DM who have or are at risk for ASCVD report low levels of PA and have low measured cardiopulmonary fitness', '150 individuals with medically treated T2DM and atherosclerotic cardiovascular disease (ASCVD) or risk factors for ASCVD were recruited from outpatient clinics at a single academic medical center', 'Participants had a mean ± SD age of 54.9 ± 9.0 years; 41% were women, 40% were black, and 21% were Hispanic', 'population of patients with T2DM']","['graded maximal exercise treadmill test to exhaustion with breath-by-breath gas exchange analysis to determine VO 2peak ', 'Lifestyle intervention']","['Aerobic Fitness and Adherence to Guideline-Recommended Minimum Physical Activity', 'Mean ± SD VO 2peak']","[{'cui': 'C0439841', 'cui_str': 'Ambulatory'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0020473', 'cui_str': 'Hyperlipemia'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0004153', 'cui_str': 'Atherosclerosis'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0002424', 'cui_str': 'Outpatient Clinics'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0000872', 'cui_str': 'University Medical Centers'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0087110', 'cui_str': 'Treadmill Test'}, {'cui': 'C0392674', 'cui_str': 'Exhaustion (finding)'}, {'cui': 'C0225386', 'cui_str': 'Breath (substance)'}, {'cui': 'C0596601', 'cui_str': 'Gas'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}]","[{'cui': 'C0220845', 'cui_str': 'guidelines'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",150.0,0.0445548,"Mean ± SD VO 2peak was 27.4 ± 6.5 mL/kg fat-free mass/min (18.8 ± 5.0 mL/kg/min). ","[{'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Jarvie', 'Affiliation': 'Division of Cardiology, University of Colorado School of Medicine, Aurora, CO.'}, {'ForeName': 'Ambarish', 'Initials': 'A', 'LastName': 'Pandey', 'Affiliation': 'Division of Cardiology, University of Texas Southwestern Medical Center, Dallas, TX.'}, {'ForeName': 'Colby R', 'Initials': 'CR', 'LastName': 'Ayers', 'Affiliation': 'Department of Clinical Sciences, University of Texas Southwestern Medical Center, Dallas, TX.'}, {'ForeName': 'Jonathan M', 'Initials': 'JM', 'LastName': 'McGavock', 'Affiliation': 'Manitoba Institute of Child Health, Winnipeg, Manitoba, Canada.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Sénéchal', 'Affiliation': 'Cardio-Metabolic Exercise and Lifestyle Laboratory, Fredericton, New Brunswick, Canada.'}, {'ForeName': 'Jarett D', 'Initials': 'JD', 'LastName': 'Berry', 'Affiliation': 'Division of Cardiology, University of Texas Southwestern Medical Center, Dallas, TX.'}, {'ForeName': 'Kershaw V', 'Initials': 'KV', 'LastName': 'Patel', 'Affiliation': 'Division of Cardiology, University of Texas Southwestern Medical Center, Dallas, TX.'}, {'ForeName': 'Darren K', 'Initials': 'DK', 'LastName': 'McGuire', 'Affiliation': 'Division of Cardiology, University of Texas Southwestern Medical Center, Dallas, TX darren.mcguire@utsouthwestern.edu.'}]",Diabetes care,['10.2337/dc18-2634'] 446,32240304,Supplementation with Fortified Lipid-Based and Blended Complementary Foods has Variable Impact on Body Composition Among Rural Bangladeshi Children: A Cluster-Randomized Controlled Trial.,"BACKGROUND Complementary food supplementation enhances linear growth and may affect body composition in children. OBJECTIVE We aimed to determine the effect of complementary food supplements provided from the age of 6 to 18 mo on fat-free mass (FFM) and fat mass (FM) gain among children in rural Bangladesh. METHODS In an unblinded, cluster-randomized, controlled trial we tested the effects of 4 complementary food supplements for 1 y [chickpea, rice lentil, Plumpy'doz, and wheat-soy-blend++ (WSB++)] compared with no supplements on linear growth. Body composition was estimated using weight-length-based, age- and sex-specific equations at 6, 9, 12, 15, and 18 mo and postintervention aged 24 mo. Generalized estimating equations (GEEs) were applied to estimate the effect of each complementary food on mean FFM and FM from 9 to 18 and 24 mo compared with the control, adjusting for baseline measures. Sex interactions were also explored. RESULTS In total, 3592 (65.9% of enrolled) children completed all anthropometric assessments. Estimated FFM and FM (mean ± SD) were 5.3 ± 0.6 kg and 1.4 ± 0.4 kg, respectively, at the age of 6 mo. Mean ± SE FFM and FM from 9 to 18 mo were 75.4 ± 14.0 g and 32.9 ± 7.1 g, and 61.0 ± 16.6 g and 30.0 ± 8.4 g, higher with Plumpy'doz and chickpea foods, respectively, than the control (P < 0.001). Estimated FFM was 41.5 ± 16.6 g higher in rice-lentil-fed versus control (P < 0.05) children. WSB++ had no impact on FFM or FM. A group-sex interaction (P < 0.1) was apparent with Plumpy'doz and rice-lentil foods, with girls involved in the intervention having higher estimated FFM and FM than control girls compared with no significant effect in boys. At 24 mo, FFM and FM remained higher only in girls eating Plumpy'doz compared with the controls (P < 0.01). CONCLUSIONS In this randomized trial, supplementation effected small shifts in apparent body composition in rural Bangladeshi children. Where seen, FFM increments were twice that of FM, in proportion to these compartments, and more pronounced in girls. FFM increased in line with reported improvements in length. This trial was registered at clinicaltrials.gov as NCT01562379.",2020,"At 24 mo, FFM and FM remained higher only in girls eating Plumpy'doz compared with the controls (P < 0.01). ","['Rural Bangladeshi Children', 'children', 'rural Bangladeshi children']","['Fortified Lipid-Based and Blended Complementary Foods', ""4 complementary food supplements for 1 y [chickpea, rice lentil, Plumpy'doz, and wheat-soy-blend++ (WSB"", 'WSB']","['FFM or FM', 'Body composition', 'Estimated FFM and FM (mean\xa0±\xa0SD', 'fat-free mass (FFM) and fat mass (FM) gain', 'Mean\xa0±', 'Body Composition', 'length', 'FFM', 'FFM and FM']","[{'cui': 'C0422784', 'cui_str': 'Bangladeshi'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0950052', 'cui_str': 'Chick peas'}, {'cui': 'C0035567', 'cui_str': 'Rice'}, {'cui': 'C0023323', 'cui_str': 'Lentils'}, {'cui': 'C0043137', 'cui_str': 'Wheat'}, {'cui': 'C0037733', 'cui_str': 'Soya bean'}]","[{'cui': 'C0271093', 'cui_str': ""Stargardt's disease""}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0424679', 'cui_str': 'Fat-free mass'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C1444754', 'cui_str': 'Length'}]",3592.0,0.190282,"At 24 mo, FFM and FM remained higher only in girls eating Plumpy'doz compared with the controls (P < 0.01). ","[{'ForeName': 'Saijuddin', 'Initials': 'S', 'LastName': 'Shaikh', 'Affiliation': 'The JiVitA Project of Johns Hopkins University, Bangladesh, Gaibandha, Bangladesh.'}, {'ForeName': 'Rebecca K', 'Initials': 'RK', 'LastName': 'Campbell', 'Affiliation': 'Center for Human Nutrition, Department of International Health, Johns Hopkins University Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Sucheta', 'Initials': 'S', 'LastName': 'Mehra', 'Affiliation': 'Center for Human Nutrition, Department of International Health, Johns Hopkins University Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Alamgir', 'Initials': 'A', 'LastName': 'Kabir', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Bangladesh, Mohakhali, Dhaka, Bangladesh.'}, {'ForeName': 'Kerry J', 'Initials': 'KJ', 'LastName': 'Schulze', 'Affiliation': 'Center for Human Nutrition, Department of International Health, Johns Hopkins University Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Lee', 'Initials': 'L', 'LastName': 'Wu', 'Affiliation': 'Center for Human Nutrition, Department of International Health, Johns Hopkins University Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Hasmot', 'Initials': 'H', 'LastName': 'Ali', 'Affiliation': 'The JiVitA Project of Johns Hopkins University, Bangladesh, Gaibandha, Bangladesh.'}, {'ForeName': 'Abu Ahmed', 'Initials': 'AA', 'LastName': 'Shamim', 'Affiliation': 'James P Grant School of Public Health, Bangladesh Rural Advancement Committee (BRAC), University, Dhaka, Bangladesh.'}, {'ForeName': 'Keith P', 'Initials': 'KP', 'LastName': 'West', 'Affiliation': 'Center for Human Nutrition, Department of International Health, Johns Hopkins University Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Parul', 'Initials': 'P', 'LastName': 'Christian', 'Affiliation': 'Center for Human Nutrition, Department of International Health, Johns Hopkins University Bloomberg School of Public Health, Baltimore, MD, USA.'}]",The Journal of nutrition,['10.1093/jn/nxaa061'] 447,32240370,Sustained remission of child depression despite drift in parent emotion management skills 18 weeks following Parent Child Interaction Therapy: emotion development.,"Whether effects of psychotherapies for depression are sustained after treatment is an important clinical issue. In older depressed children and adolescents such treatments have been shown to be sustained for several months. Rates of remission ranged from 62-69% at 3 months-1 year in one large scale study. To date there has been no data to inform whether the effects of earlier interventions for depression in the preschool period are sustained. To address this, we used data from a randomized controlled trial of a novel early intervention for depression called ""Parent Child Interaction Therapy Emotion Development"" (PCIT-ED) that has shown efficacy for depression, parenting stress and parenting practices. Participants and their caregivers were re-assessed 18 weeks after treatment completion. All study procedures were approved by the Washington University School of Medicine Internal Review Board prior to data collection. Study findings demonstrated a high rate of sustained gains in remission from depression, decreased parenting stress and parental depression 18 weeks after completion of a trial of PCIT-ED in a population of young children. Parental response to the child expression of emotion, a key treatment target drifted back towards baseline after 3 months. Relapse rates were 17% and predictors of relapse were the presence of an externalizing disorder, a higher number of co-morbid disorders and poorer guilt reparation and emotion regulation measured at treatment completion. This extends the body of literature demonstrating parent-child interaction therapy (PCIT) to have sustained effects on targeted disruptive symptom profiles to early childhood depression. This relatively low relapse rate after 18 weeks is comparable or better than many empirically proven treatments for depression in older children.",2020,"Study findings demonstrated a high rate of sustained gains in remission from depression, decreased parenting stress and parental depression 18 weeks after completion of a trial of PCIT-ED in a population of young children.","['older children', 'All study procedures were approved by the Washington University School of Medicine Internal Review Board prior to data collection']","['PCIT-ED', 'parent-child interaction therapy (PCIT', 'psychotherapies', 'novel early intervention for depression called ""Parent Child Interaction Therapy Emotion Development"" (PCIT-ED']","['Rates of remission', 'Relapse rates', 'number of co-morbid disorders and poorer guilt reparation and emotion regulation']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0205540', 'cui_str': 'Approved'}, {'cui': 'C0043038', 'cui_str': 'Washington'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0010995', 'cui_str': 'Data Collection'}]","[{'cui': 'C0030542', 'cui_str': 'Parent-Child Relationship'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0033968', 'cui_str': 'Psychotherapy'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0242687', 'cui_str': 'Provision of early intervention service for child'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}]","[{'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0018379', 'cui_str': 'Feeling guilt'}, {'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}]",,0.0754405,"Study findings demonstrated a high rate of sustained gains in remission from depression, decreased parenting stress and parental depression 18 weeks after completion of a trial of PCIT-ED in a population of young children.","[{'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Luby', 'Affiliation': 'Washington University School of Medicine, Child Psychiatry, St. Louis, MO, 63130, USA. lubyj@wustl.edu.'}, {'ForeName': 'Meghan Rose', 'Initials': 'MR', 'LastName': 'Donohue', 'Affiliation': 'Washington University School of Medicine, Child Psychiatry, St. Louis, MO, 63130, USA.'}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Gilbert', 'Affiliation': 'Washington University School of Medicine, Child Psychiatry, St. Louis, MO, 63130, USA.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Tillman', 'Affiliation': 'Washington University School of Medicine, Child Psychiatry, St. Louis, MO, 63130, USA.'}, {'ForeName': 'Deanna M', 'Initials': 'DM', 'LastName': 'Barch', 'Affiliation': 'Department of Psychological and Brain Sciences, Washington University in St. Louis, St. Louis, MO, 63130, USA.'}]",European child & adolescent psychiatry,['10.1007/s00787-020-01522-7'] 448,32030526,Few Aggressive or Violent Incidents are Associated with the Use of HIV Self-tests to Screen Sexual Partners Among Key Populations.,"Men who have sex with men and transgender women who had multiple sexual partners in the prior 3 months participated in ISUM, a randomized, controlled trial of self- and partner-testing in New York City and San Juan, PR. Only 2% of screened participants were ineligible to enroll due to anticipating they would find it very hard to avoid or handle violence. The intervention group received free rapid HIV self-test kits. During the trial, 114 (88%) of intervention participants who were assessed at follow-up used self-tests with at least one potential partner. Only 6% of participants who asked a partner in person to test reported that at least one of their partners got physically violent, some in the context of sex work. In total, 16 (2%) partners reacted violently. Post-trial, only one participant reported finding it very hard to handle violence, and none found it very hard to avoid potential violence.",2020,"During the trial, 114 (88%) of intervention participants who were assessed at follow-up used self-tests with at least one potential partner.",['Men who have sex with men and transgender women who had multiple sexual partners in the prior 3\xa0months participated in'],"['ISUM', 'free rapid HIV self-test kits', 'self- and partner-testing in New York City and San Juan, PR']",[],"[{'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}, {'cui': 'C1319927', 'cui_str': 'Male-to-female transsexual'}, {'cui': 'C0558265', 'cui_str': 'Multiple sexual contacts (finding)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1272835', 'cui_str': 'Test kit'}, {'cui': 'C0682323', 'cui_str': 'Companion'}, {'cui': 'C0027977', 'cui_str': 'New York City'}]",[],114.0,0.0231364,"During the trial, 114 (88%) of intervention participants who were assessed at follow-up used self-tests with at least one potential partner.","[{'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Carballo-Diéguez', 'Affiliation': 'HIV Center for Clinical and Behavioral Studies, Division of Gender, Sexuality and Health, NY State Psychiatric Institute and Columbia University, 1051 Riverside Drive, Unit 15, New York, NY, 10032, USA.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Giguere', 'Affiliation': 'HIV Center for Clinical and Behavioral Studies, Division of Gender, Sexuality and Health, NY State Psychiatric Institute and Columbia University, 1051 Riverside Drive, Unit 15, New York, NY, 10032, USA. rebecca.giguere@nyspi.columbia.edu.'}, {'ForeName': 'Iván C', 'Initials': 'IC', 'LastName': 'Balán', 'Affiliation': 'HIV Center for Clinical and Behavioral Studies, Division of Gender, Sexuality and Health, NY State Psychiatric Institute and Columbia University, 1051 Riverside Drive, Unit 15, New York, NY, 10032, USA.'}, {'ForeName': 'Curtis', 'Initials': 'C', 'LastName': 'Dolezal', 'Affiliation': 'HIV Center for Clinical and Behavioral Studies, Division of Gender, Sexuality and Health, NY State Psychiatric Institute and Columbia University, 1051 Riverside Drive, Unit 15, New York, NY, 10032, USA.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Brown', 'Affiliation': 'HIV Center for Clinical and Behavioral Studies, Division of Gender, Sexuality and Health, NY State Psychiatric Institute and Columbia University, 1051 Riverside Drive, Unit 15, New York, NY, 10032, USA.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Lopez-Rios', 'Affiliation': 'HIV Center for Clinical and Behavioral Studies, Division of Gender, Sexuality and Health, NY State Psychiatric Institute and Columbia University, 1051 Riverside Drive, Unit 15, New York, NY, 10032, USA.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Sheinfil', 'Affiliation': 'Department of Psychology, Syracuse University, Syracuse, USA.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Frasca', 'Affiliation': 'HIV Center for Clinical and Behavioral Studies, Division of Gender, Sexuality and Health, NY State Psychiatric Institute and Columbia University, 1051 Riverside Drive, Unit 15, New York, NY, 10032, USA.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Rael', 'Affiliation': 'HIV Center for Clinical and Behavioral Studies, Division of Gender, Sexuality and Health, NY State Psychiatric Institute and Columbia University, 1051 Riverside Drive, Unit 15, New York, NY, 10032, USA.'}, {'ForeName': 'Cody', 'Initials': 'C', 'LastName': 'Lentz', 'Affiliation': 'HIV Center for Clinical and Behavioral Studies, Division of Gender, Sexuality and Health, NY State Psychiatric Institute and Columbia University, 1051 Riverside Drive, Unit 15, New York, NY, 10032, USA.'}, {'ForeName': 'Raynier', 'Initials': 'R', 'LastName': 'Crespo', 'Affiliation': 'Department of Pediatrics, University of Puerto Rico Medical Sciences Campus, San Juan, USA.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Cruz Torres', 'Affiliation': 'Department of Pediatrics, University of Puerto Rico Medical Sciences Campus, San Juan, USA.'}, {'ForeName': 'Cheng-Shiun', 'Initials': 'CS', 'LastName': 'Leu', 'Affiliation': 'HIV Center for Clinical and Behavioral Studies, Division of Gender, Sexuality and Health, NY State Psychiatric Institute and Columbia University, 1051 Riverside Drive, Unit 15, New York, NY, 10032, USA.'}, {'ForeName': 'Irma', 'Initials': 'I', 'LastName': 'Febo', 'Affiliation': 'Department of Pediatrics, University of Puerto Rico Medical Sciences Campus, San Juan, USA.'}]",AIDS and behavior,['10.1007/s10461-020-02809-1'] 449,30797673,Comparison of the Effectiveness of Two Different Methods of Decreasing Pain During Phlebotomy in Children: A Randomized Controlled Trial.,"PURPOSE The purpose of this study was to examine the effect of the applications of external cold and vibration and blowing soap bubbles during phlebotomy in children aged between 3 and 6 years. DESIGN This study is a randomized controlled trial. METHODS The sample was obtained using block randomization. Children were divided into three groups: ""external cold and vibration group,"" ""blowing soap bubbles group,"" and ""control group."" Children, their parents, the nurse, and the researcher rated the children's pain during phlebotomy. FINDINGS A statistically significant difference between groups was found on pain scores. Pain scores were lower in the groups of external cold and vibration, and blowing soap bubbles than the control group. CONCLUSIONS The methods of external cold and vibration and blowing soap bubbles had a pain relieving effect in children aged between 3 and 6 years during phlebotomy.",2019,"Pain scores were lower in the groups of external cold and vibration, and blowing soap bubbles than the control group. ","['Children', 'children aged between 3 and 6\xa0years', 'children aged between 3 and 6\xa0years during phlebotomy']","['external cold and vibration and blowing soap bubbles', 'external cold and vibration group,"" ""blowing soap bubbles group,"" and ""control group']","['Pain', 'Pain scores', 'pain relieving effect', 'pain scores']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0190979', 'cui_str': 'Venesection'}]","[{'cui': 'C0205101', 'cui_str': 'External (qualifier value)'}, {'cui': 'C0009443', 'cui_str': 'Common Cold'}, {'cui': 'C0459800', 'cui_str': 'Vibration'}, {'cui': 'C0037392', 'cui_str': 'Soap'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}]",,0.0516521,"Pain scores were lower in the groups of external cold and vibration, and blowing soap bubbles than the control group. ","[{'ForeName': 'Şeyda', 'Initials': 'Ş', 'LastName': 'Binay', 'Affiliation': ''}, {'ForeName': 'Elif', 'Initials': 'E', 'LastName': 'Bilsin', 'Affiliation': ''}, {'ForeName': 'Gülçin Ö', 'Initials': 'GÖ', 'LastName': 'Gerçeker', 'Affiliation': ''}, {'ForeName': 'Ayşe', 'Initials': 'A', 'LastName': 'Kahraman', 'Affiliation': ''}, {'ForeName': 'Hatice', 'Initials': 'H', 'LastName': 'Bal-Yılmaz', 'Affiliation': ''}]",Journal of perianesthesia nursing : official journal of the American Society of PeriAnesthesia Nurses,['10.1016/j.jopan.2018.11.010'] 450,31961448,A fully Bayesian mixture model approach for identifying noncompliance in a regulatory tobacco clinical trial.,"Identifying noncompliance in a randomized trial is challenging, but could be improved by leveraging biomarker data to identify participants that did not comply with their assigned treatment. For randomized trials of very low nicotine content (VLNC) cigarettes, the biomarker of total nicotine equivalents (TNE) could be used to identify noncompliance. Compliant participants should have lower levels of TNEs than participants that did not comply and smoked normal nicotine content cigarettes, resulting in a mixture of compliant and noncompliant participants at each dose level. Thresholds of TNE could then be identified from the compliant groups at each dose level and used to determine which study participants were compliant. Furthermore, proposed biological relationships of TNE with nicotine dose could be incorporated into improve the efficiency of estimation, but may introduce bias if misspecified. To account for multiple modeling assumptions across dose levels, we explore model averaging via reversible jump markov chain monte carlo (MCMC) within each dose level to take advantage of improvements in efficiency when the proposed relationship is true and to downweight the biological model when it is misspecified. In simulation studies, we demonstrate that model averaging in the presence of a correct biological relationship results in a decrease in the mean square error (MSE) of up to 85%, but downweights the model in dose levels where the relationship is not appropriate. We apply our approach to data from a randomized trial of VLNC cigarettes to estimate TNE thresholds and probability of compliance curves as a function of TNEs for each nicotine dose used in the trial.",2020,"In simulation studies, we demonstrate that model averaging in the presence of a correct biological relationship results in a decrease in the mean square error (MSE) of up to 85%, but downweights the model in dose levels where the relationship is not appropriate.",[],"['VLNC', 'total nicotine equivalents (TNE', 'low nicotine content (VLNC) cigarettes', 'TNE']",['mean square error (MSE'],[],"[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0205120', 'cui_str': 'Square (qualifier value)'}]",,0.0934155,"In simulation studies, we demonstrate that model averaging in the presence of a correct biological relationship results in a decrease in the mean square error (MSE) of up to 85%, but downweights the model in dose levels where the relationship is not appropriate.","[{'ForeName': 'Alexander M', 'Initials': 'AM', 'LastName': 'Kaizer', 'Affiliation': 'Department of Biostatistics and Informatics, University of Colorado-Anschutz Medical Campus, Aurora, Colorado.'}, {'ForeName': 'Joseph S', 'Initials': 'JS', 'LastName': 'Koopmeiners', 'Affiliation': 'Division of Biostatistics, University of Minnesota, Minneapolis, Minnesota.'}]",Statistics in medicine,['10.1002/sim.8478'] 451,32243582,Enhanced serotonin availability amplifies fatigue perception and modulates the TMS-induced silent period during sustained low-intensity elbow flexions.,"KEY POINTS During maximal effort contractions, intense serotonin release via the raphe-spinal pathway spills over from the somato-dendritic compartment to activate inhibitory 5-HT 1A receptors on the axon initial segment of motoneurons to reduce motoneuronal output. We investigated whether the same mechanism of central fatigue is present for low-intensity contractions, whereby weak serotonergic drive over an extended period may cause accumulation of serotonin and exacerbate central fatigue. Enhanced availability of serotonin did not directly influence motor pathways or motor performance during prolonged submaximal contraction. However, perceptions of muscle fatigue were greater, and the fatigue-induced lengthening of the silent period elicited via motor cortical stimulation was reduced with enhanced availability of serotonin. We propose that sustained low-intensity serotonergic neurotransmission influences supraspinal processes associated with fatigue, without directly influencing the output of the motor system during submaximal exercise. ABSTRACT Enhanced availability of serotonin (5-HT) exacerbates central fatigue that occurs during maximal effort contractions. However, it is unknown if 5-HT release contributes to central fatigue during prolonged submaximal contractions. Hence, we assessed the effect that enhanced availability of 5-HT has on sustained low-intensity fatiguing contractions. Fifteen individuals (22.3 ± 2.1 years) ingested the 5-HT reuptake inhibitor paroxetine in a human, double-blinded, placebo-controlled, repeated-measures design. Participants performed a low-intensity isometric elbow flexion for 30 min (15% of maximal voluntary contraction, MVC). Throughout the protocol, brief MVCs were performed and muscle responses to transcranial magnetic stimulation (TMS) of the motor cortex, electrical stimulation of the brachial plexus, and motor point stimulation of the biceps were obtained. Ratings of perceived fatigue were also acquired. Paroxetine did not influence torque or voluntary activation during brief MVCs performed throughout the low-intensity contraction. However, paroxetine increased the perception of fatigue throughout the contraction (P = 0.005), and shortened the biceps silent period elicited via TMS during sustained submaximal contraction (P = 0.003) and brief MVCs (P = 0.011). Overall, it appears that prolonged low-intensity contractions do not cause intense 5-HT release onto motoneurons, and therefore, 5-HT does not activate inhibitory extra-synaptic 5-HT 1A receptors of motoneurons to reduce their output. Although motor performance was unaffected by paroxetine, perceived fatigue was greater and intracortical inhibitory activity was reduced following the enhancement of endogenous concentrations of 5-HT during sustained submaximal contraction. Thus, 5-HT affects supraspinal processes during low-intensity contractions without directly altering motor pathways projecting to the muscle.",2020,"Although motor performance was unaffected by paroxetine, perceived fatigue was greater and intracortical inhibitory activity was reduced following the enhancement of endogenous concentrations of 5-HT during sustained submaximal contraction.",['Fifteen individuals (22.3\xa0±\xa02.1\xa0yr) ingested the'],"['low-intensity isometric elbow flexion', 'serotonin (5-HT', 'Paroxetine', 'paroxetine', 'serotonin', '5-HT', '5-HT reuptake inhibitor paroxetine']","['perception of fatigue', 'Ratings of perceived fatigue', 'brief MVCs', 'muscle fatigue', 'intracortical inhibitory activity', 'torque or voluntary activation']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C4068876', 'cui_str': '2.1'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}]","[{'cui': 'C0596836', 'cui_str': 'Light intensity'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0013769', 'cui_str': 'Elbow region structure'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0036751', 'cui_str': 'Serotonin'}, {'cui': 'C0070122', 'cui_str': 'Paroxetine'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0242979', 'cui_str': 'Muscle fatigue'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0318082', 'cui_str': 'Ruminococcus torques'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}]",,0.04441,"Although motor performance was unaffected by paroxetine, perceived fatigue was greater and intracortical inhibitory activity was reduced following the enhancement of endogenous concentrations of 5-HT during sustained submaximal contraction.","[{'ForeName': 'Jacob R', 'Initials': 'JR', 'LastName': 'Thorstensen', 'Affiliation': 'Menzies Health Institute Queensland, Griffith University, Gold Coast, Australia.'}, {'ForeName': 'Janet L', 'Initials': 'JL', 'LastName': 'Taylor', 'Affiliation': 'School of Medical and Health Sciences, Edith Cowan University, Perth, Australia.'}, {'ForeName': 'Murray G', 'Initials': 'MG', 'LastName': 'Tucker', 'Affiliation': 'Mental Health, Drugs and Alcohol Service, Barwon Health, University Hospital Geelong, Geelong, Victoria, Australia.'}, {'ForeName': 'Justin J', 'Initials': 'JJ', 'LastName': 'Kavanagh', 'Affiliation': 'Menzies Health Institute Queensland, Griffith University, Gold Coast, Australia.'}]",The Journal of physiology,['10.1113/JP279347'] 452,31826731,Neuroimaging in Ischemic Stroke Is Different Between Men and Women in the DEFUSE 3 Cohort.,"Background and Purpose- Clinical deficits from ischemic stroke are more severe in women, but the pathophysiological basis of this sex difference is unknown. Sex differences in core and penumbral volumes and their relation to outcome were assessed in this substudy of the DEFUSE 3 clinical trial (Endovascular Therapy Following Imaging Evaluation for Ischemic Stroke). Methods- DEFUSE 3 randomized patients to thrombectomy or medical management who presented 6 to 16 hours from last known well with proximal middle cerebral artery or internal carotid artery occlusion and had target core and perfusion mismatch volumes on computed tomography or magnetic resonance imaging. Using univariate and adjusted regression models, the effect of sex was assessed on prerandomization measures of core, perfusion, and mismatch volumes and hypoperfusion intensity ratio, and on core volume growth using 24-hour scans. Results- All patients were included in the analysis (n=182) with 90 men and 92 women. There was no sex difference in the site of baseline arterial occlusion. Adjusted by age, baseline National Institutes of Health Stroke Scale, baseline modified Rankin Scale score, time to randomization, and imaging modality, women had smaller core, hypoperfusion, and penumbral volumes than men. Median (interquartile range) volumes for core were 8.0 mL (1.9-18.4) in women versus 12.6 mL (2.7-29.6) in men, for T max >6 seconds 89.0 mL (63.8-131.7) versus 133.9 mL (87.0-175.4), and for mismatch 82.1mL (53.8-112.8) versus 108.2 (64.1-149.2). The hypoperfusion intensity ratio was lower in women, 0.31 (0.15-0.46) versus 0.39 (0.26-0.57), P =0.006, indicating better collateral circulation, which was consistent with the observed slower ischemic core growth than men within the medical group ( P =0.003). Conclusions- In the large vessel ischemic stroke cohort selected for DEFUSE 3, women had imaging evidence of better collateral circulation, smaller baseline core volumes, and slower ischemic core growth. These observations suggest sex differences in hemodynamic and temporal features of anterior circulation large artery occlusions. Registration- URL: https://www.clinicaltrials.gov. Unique identifier: NCT02586415.",2020,"The hypoperfusion intensity ratio was lower in women, 0.31 (0.15-0.46) versus 0.39 (0.26-0.57), P =0.006, indicating better collateral circulation, which was consistent with the observed slower ischemic core growth than men within the medical group ( P =0.003).","['All patients were included in the analysis (n=182) with 90 men and 92 women', 'Men and Women in the DEFUSE 3 Cohort', 'patients to thrombectomy or medical management who presented 6 to 16 hours from last known well with proximal middle cerebral artery or internal carotid artery occlusion and had target core and perfusion mismatch volumes on computed tomography or magnetic resonance imaging']","[' and Purpose', 'Conclusions', 'Methods']","['prerandomization measures of core, perfusion, and mismatch volumes and hypoperfusion intensity ratio, and on core volume growth using 24-hour scans', 'Median (interquartile range) volumes', 'Health Stroke Scale, baseline modified Rankin Scale score, time to randomization, and imaging modality, women had smaller core, hypoperfusion, and penumbral volumes', 'hypoperfusion intensity ratio']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0162578', 'cui_str': 'Thrombectomy'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C0205309', 'cui_str': 'Known (qualifier value)'}, {'cui': 'C0205107', 'cui_str': 'Proximal (qualifier value)'}, {'cui': 'C0149566', 'cui_str': 'Middle Cerebral Artery'}, {'cui': 'C0007276', 'cui_str': 'Carotid Artery, Internal'}, {'cui': 'C0441597', 'cui_str': 'Occlusion - action (qualifier value)'}, {'cui': 'C0444669', 'cui_str': 'Core (qualifier value)'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}, {'cui': 'C1552358', 'cui_str': 'Magnetic resonance imaging'}]","[{'cui': 'C1285529', 'cui_str': 'Purpose (attribute)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}]","[{'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0444669', 'cui_str': 'Core (qualifier value)'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0442856', 'cui_str': 'Hypoperfusion (qualifier value)'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C0441633'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0222045'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C1275506', 'cui_str': 'Imaging modality'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}]",182.0,0.369744,"The hypoperfusion intensity ratio was lower in women, 0.31 (0.15-0.46) versus 0.39 (0.26-0.57), P =0.006, indicating better collateral circulation, which was consistent with the observed slower ischemic core growth than men within the medical group ( P =0.003).","[{'ForeName': 'Adrienne N', 'Initials': 'AN', 'LastName': 'Dula', 'Affiliation': 'From the Department of Neurology (A.N.D., N.D.Z., S.J.W.), Dell Medical School at The University of Texas, Austin.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Mlynash', 'Affiliation': 'Stanford Stroke Center, Stanford University, Palo Alto, CA (M.M., G.W.A.).'}, {'ForeName': 'Nathan D', 'Initials': 'ND', 'LastName': 'Zuck', 'Affiliation': 'From the Department of Neurology (A.N.D., N.D.Z., S.J.W.), Dell Medical School at The University of Texas, Austin.'}, {'ForeName': 'Gregory W', 'Initials': 'GW', 'LastName': 'Albers', 'Affiliation': 'Stanford Stroke Center, Stanford University, Palo Alto, CA (M.M., G.W.A.).'}, {'ForeName': 'Steven J', 'Initials': 'SJ', 'LastName': 'Warach', 'Affiliation': 'From the Department of Neurology (A.N.D., N.D.Z., S.J.W.), Dell Medical School at The University of Texas, Austin.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Stroke,['10.1161/STROKEAHA.119.028205'] 453,30946599,Parental Defensiveness about Multifactorial Genomic and Environmental Causes of Children's Obesity Risk.,"Background: Future integration of genomics into weight management may target children with overweight given prospects for prevention. Meanwhile, parents learn about weight-related genomics primarily through the media, and little is known about parental reactions to complex genomic and environmental causes underlying children's obesity risk. Methods: Three hundred twenty-four parents with overweight who have a child 3-13 years of age were recruited through Amazon Mechanical Turk. Parents were randomized to read an article highlighting one of three causes of obesity risk: genetics only, family environment only, gene-family environment interactions (G × FE), or read a control article. Results: Parents who perceived their child to be overweight exhibited increased risk perception and guilt over parents of lean children overall, but exhibited decreased worry in response to the G × FE message. Furthermore, parents of children with overweight who received the G × FE message did not exhibit heightened risk perception or guilt, reported that the message was less relevant, and that they paid less attention to it. Conclusions: Multifactorial causal information about children's obesity risk elicits unintended consequences among parents whose children are most at-risk for obesity in adulthood. As these messages are most accurate, it is crucial to investigate effective ways to communicate the holistic nature of obesity risk to parents.",2019,"Results: Parents who perceived their child to be overweight exhibited increased risk perception and guilt over parents of lean children overall, but exhibited decreased worry in response to the G × FE message.","['parents of children with overweight', ""Children's Obesity Risk"", 'Methods: Three hundred twenty-four parents with overweight who have a child 3-13 years of age were recruited through Amazon Mechanical Turk']","['family environment only, gene-family environment interactions (G\u2009×\u2009FE), or read a control article']",['risk perception and guilt'],"[{'cui': 'C0030551', 'cui_str': 'Parent of (observable entity)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C2362324', 'cui_str': 'Childhood Onset Obesity'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C3715070', 'cui_str': '24 (qualifier value)'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0443254', 'cui_str': 'Mechanical (qualifier value)'}, {'cui': 'C0337911', 'cui_str': 'Turks (ethnic group)'}]","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0017337', 'cui_str': 'Genes'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0018379', 'cui_str': 'Guilt'}]",324.0,0.0271307,"Results: Parents who perceived their child to be overweight exhibited increased risk perception and guilt over parents of lean children overall, but exhibited decreased worry in response to the G × FE message.","[{'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Persky', 'Affiliation': '1 Social and Behavioral Research Branch, National Human Genome Research Institute, Bethesda, MD.'}, {'ForeName': 'Megan R', 'Initials': 'MR', 'LastName': 'Goldring', 'Affiliation': '2 Department of Psychology, Columbia University, New York, NY.'}, {'ForeName': 'Sherine', 'Initials': 'S', 'LastName': 'El-Toukhy', 'Affiliation': '3 Division of Intramural Research, National Institute on Minority Health and Health Disparities, Bethesda, MD.'}, {'ForeName': 'Rebecca A', 'Initials': 'RA', 'LastName': 'Ferrer', 'Affiliation': '4 Behavioral Research Program, National Cancer Institute, Bethesda, MD.'}, {'ForeName': 'Brittany', 'Initials': 'B', 'LastName': 'Hollister', 'Affiliation': '1 Social and Behavioral Research Branch, National Human Genome Research Institute, Bethesda, MD.'}]",Childhood obesity (Print),['10.1089/chi.2018.0315'] 454,31517773,Effects of prophylactic iron supplementation on outcome of nonanemic pregnant women: A non-randomized clinical trial.,"BACKGROUND The aim of the current study was to investigate the effects of prophylactic iron supplementation on the pregnancy outcome of nonanemic pregnant women in a sample of Iranian population. METHODS This non-randomized clinical trial was conducted during a 2-year period in obstetrics clinics of Shiraz, southern Iran. We included a sample of singleton pregnancies registered in our clinics. Those with comorbidities were excluded. Serum ferritin was measured at baseline and participants were classified accordingly: those with normal serum ferritin levels (≥30 µg/dL) who received standard prophylactic iron supplementation during the pregnancy (Group 1); those who had minor thalassemia and elevated serum ferritin levels (≥30 µg/dL) who did not receive prophylactic iron supplementation or those with normal ferritin levels (≥30 µg/dL) who refused to receive iron supplementation due to gastrointestinal upset (Group 2); and those with iron deficiency anemia with low serum ferritin levels (<30 µg/dL) who received standard iron supplementation during pregnancy (Group 3). All the participants were followed to the delivery and maternal and neonatal outcomes were recorded and compared between three study groups. RESULTS Overall we included 30 pregnant women in each group with mean age of the participants was 28.66 ± 6.02 years. There was no significant difference between three study groups regarding gestational age at delivery (p = 0.250), birthweight (p = 0.893), Apgar at 1 (p = 0.532) and 5 (p = 0.590) minutes, and route of delivery (p = 0.590). The overall rate of maternal complication of the pregnancy was comparable between the three study groups (p = 0.188). However, those in group 1, had significantly higher rate of gestational diabetes mellitus (GDM) when compared to other two groups (p = 0.038). CONCLUSION Prophylactic iron supplementation in pregnant women with normal ferritin levels is associated with increased risk of GDM. Other pregnancy and neonatal outcomes are not affected by the prophylactic iron supplementation.",2019,The overall rate of maternal complication of the pregnancy was comparable between the three study groups (p=0.188).,"['Nonanemic Pregnant Women', 'singleton pregnancies registered in our clinics', 'nonanemic pregnant women in a sample of Iranian population', '30 pregnant women in each group with mean age of the participants was 28.66 ±\u20096.02 years', 'during the pregnancy (Group 1); those who had minor thalassemia and elevated serum ferritin levels (≥30 µg/dL) who did not receive', 'obstetrics clinics of Shiraz, southern Iran', 'pregnant women with normal ferritin levels']","['prophylactic iron supplementation', 'Prophylactic iron supplementation', 'Prophylactic Iron Supplementation', 'standard prophylactic iron supplementation', 'prophylactic iron supplementation or those with normal ferritin levels (≥30 µg/dL) who refused to receive iron supplementation due to gastrointestinal upset (Group 2); and those with iron deficiency anemia with low serum ferritin levels (<30 µg/dL) who received standard iron supplementation']","['overall rate of maternal complication of the pregnancy', 'rate of gestational diabetes mellitus', 'Serum ferritin', 'risk of gestational diabetes mellitus (GDM']","[{'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0554962', 'cui_str': 'Iranian (NMO) (ethnic group)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0441861', 'cui_str': 'Group 1 (qualifier value)'}, {'cui': 'C0026193', 'cui_str': 'Minors'}, {'cui': 'C0039730', 'cui_str': 'Thalassemia'}, {'cui': 'C0696113', 'cui_str': 'Serum ferritin measurement'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C0022065', 'cui_str': 'Islamic Republic of Iran'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0373607', 'cui_str': 'Ferritin measurement (procedure)'}]","[{'cui': 'C0445202', 'cui_str': 'Prophylactic (qualifier value)'}, {'cui': 'C3537005', 'cui_str': 'Iron supplement therapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0373607', 'cui_str': 'Ferritin measurement (procedure)'}, {'cui': 'C1705116', 'cui_str': 'Refused (qualifier value)'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C2697368', 'cui_str': 'Gastrointestinal irritation (disorder)'}, {'cui': 'C0441865', 'cui_str': 'Group 2 (qualifier value)'}, {'cui': 'C0162316', 'cui_str': 'Iron deficiency anemia (disorder)'}, {'cui': 'C4076066', 'cui_str': 'Serum ferritin level low (finding)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0085207', 'cui_str': 'Diabetes, Pregnancy-Induced'}, {'cui': 'C0696113', 'cui_str': 'Serum ferritin measurement'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",30.0,0.275818,The overall rate of maternal complication of the pregnancy was comparable between the three study groups (p=0.188).,"[{'ForeName': 'Nasrin', 'Initials': 'N', 'LastName': 'Asadi', 'Affiliation': 'Maternal-Fetal Medicine Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Homeira', 'Initials': 'H', 'LastName': 'Vafaei', 'Affiliation': 'Maternal-Fetal Medicine Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Kasraeian', 'Affiliation': 'Maternal-Fetal Medicine Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Sedigeh', 'Initials': 'S', 'LastName': 'Yoosefi', 'Affiliation': 'Perinatology Division, Maternal-Fetal Medicine Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Azam', 'Initials': 'A', 'LastName': 'Faraji', 'Affiliation': 'Perinatology Division, Maternal-Fetal Medicine Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Lilia', 'Initials': 'L', 'LastName': 'Abbasi', 'Affiliation': 'Department of Obstetrics and Gynecology, Shiraz University of Medical Sciences, Shiraz, Iran.'}]",Journal of the Chinese Medical Association : JCMA,['10.1097/JCMA.0000000000000184'] 455,32142970,Daily watermelon consumption decreases plasma sVCAM-1 levels in overweight and obese postmenopausal women.,"Postmenopausal status is associated with an increase in total and abdominal body fat as well as increased incidence of insulin resistance and cardiovascular disease. The purpose of this study was to determine if watermelon supplementation affects select systemic markers of atherosclerosis and measures of insulin resistance in overweight and obese postmenopausal women. We hypothesized that overweight and obese postmenopausal women consuming 100% watermelon puree daily for 6 weeks would have improved levels of select systemic markers connected with cardiovascular disease without changing markers of insulin resistance. To test this hypothesis, overweight and obese postmenopausal women were recruited to participate in this study. Participants were randomly assigned to either the control group (no intervention) or the watermelon puree group (WM) for 6 weeks. Plasma concentration of markers connected with atherosclerosis and glycemic control were measured pre- and poststudy. A significant 6% decrease in soluble vascular cell adhesion molecule-1 occurred pre- to poststudy in WM, P = .003. The pattern of change in fasting blood glucose (P = .633), insulin (P = .158), and homeostatic model assessment-estimated insulin resistance (P = .174) did not differ between groups. Pre- to poststudy increases were measured in the fasting plasma concentration of l-arginine (8%, P = .005), cis-lycopene (32%, P = .003), and trans-lycopene (42%, P = .003) in WM. We conclude that 6 weeks of watermelon supplementation improved soluble vascular cell adhesion molecule-1 levels, a marker connected to atherogenesis, independent of changes in body composition or glycemic control.",2020,"The pattern of change in fasting blood glucose (P = .633), insulin (P = .158), and homeostatic model assessment-estimated insulin resistance (P = .174) did not differ between groups.",['overweight and obese postmenopausal women'],"['control group (no intervention) or the watermelon puree', 'watermelon supplementation', 'Daily watermelon consumption']","['soluble vascular cell adhesion molecule-1', 'soluble vascular cell adhesion molecule-1 levels', 'body composition or glycemic control', 'homeostatic model assessment-estimated insulin resistance', 'total and abdominal body fat', 'Plasma concentration of markers connected with atherosclerosis and glycemic control', 'fasting plasma concentration of l-arginine', 'trans-lycopene', 'plasma sVCAM-1 levels', 'fasting blood glucose']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0973455', 'cui_str': 'Watermelon'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]","[{'cui': 'C0078056', 'cui_str': 'CD106 Antigens'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0000726', 'cui_str': 'Abdomen'}, {'cui': 'C0344335', 'cui_str': 'Body Fat'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0004153', 'cui_str': 'Atherosclerosis'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0003765', 'cui_str': 'Arginine'}, {'cui': 'C0065331', 'cui_str': 'lycopene'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}]",,0.0557965,"The pattern of change in fasting blood glucose (P = .633), insulin (P = .158), and homeostatic model assessment-estimated insulin resistance (P = .174) did not differ between groups.","[{'ForeName': 'R Andrew', 'Initials': 'RA', 'LastName': 'Shanely', 'Affiliation': 'Appalachian State University, Department of Health and Exercise Science, 1179 State Farm Rd, Boone, NC 28608. Electronic address: shanelyra@appstate.edu.'}, {'ForeName': 'Jennifer J', 'Initials': 'JJ', 'LastName': 'Zwetsloot', 'Affiliation': 'Appalachian State University, Department of Health and Exercise Science, 1179 State Farm Rd, Boone, NC 28608. Electronic address: zwetslootjj@appstate.edu.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Jurrissen', 'Affiliation': 'Appalachian State University, Department of Health and Exercise Science, 1179 State Farm Rd, Boone, NC 28608. Electronic address: tjjmy9@mail.missouri.edu.'}, {'ForeName': 'Lauren C', 'Initials': 'LC', 'LastName': 'Hannan', 'Affiliation': 'Appalachian State University, Department of Health and Exercise Science, 1179 State Farm Rd, Boone, NC 28608. Electronic address: lauren.hannan@performance-therapy.com.'}, {'ForeName': 'Kevin A', 'Initials': 'KA', 'LastName': 'Zwetsloot', 'Affiliation': 'Appalachian State University, Department of Health and Exercise Science, 1179 State Farm Rd, Boone, NC 28608. Electronic address: zwetslootka@appstate.edu.'}, {'ForeName': 'Alan R', 'Initials': 'AR', 'LastName': 'Needle', 'Affiliation': 'Appalachian State University, Department of Health and Exercise Science, 1179 State Farm Rd, Boone, NC 28608. Electronic address: needlear@appstate.edu.'}, {'ForeName': 'Anna E', 'Initials': 'AE', 'LastName': 'Bishop', 'Affiliation': 'Appalachian State University, Department of Health and Exercise Science, 1179 State Farm Rd, Boone, NC 28608. Electronic address: abishop@highpoint.edu.'}, {'ForeName': 'Guoyao', 'Initials': 'G', 'LastName': 'Wu', 'Affiliation': 'Texas A&M University, Department of Animal Science, 2471 TAMU, College Station, TX, 77843. Electronic address: g-wu@exchange.tamu.edu.'}, {'ForeName': 'Penelope', 'Initials': 'P', 'LastName': 'Perkins-Veazie', 'Affiliation': 'North Carolina State University, Department of Horticultural Science, Plants for Human Health Institute, North Carolina Research Campus, 600 Laureate Way, Kannapolis, NC 28081. Electronic address: penelope_perkins@ncsu.edu.'}]","Nutrition research (New York, N.Y.)",['10.1016/j.nutres.2020.02.005'] 456,32239210,Effect of Delayed Targeted Intraoperative Radiotherapy vs Whole-Breast Radiotherapy on Local Recurrence and Survival: Long-term Results From the TARGIT-A Randomized Clinical Trial in Early Breast Cancer.,"Importance Conventional adjuvant radiotherapy for breast cancer given daily for several weeks is onerous and expensive. Some patients may be obliged to choose a mastectomy instead, and some may forgo radiotherapy altogether. We proposed a clinical trial to test whether radiotherapy could be safely limited to the tumor bed. Objective To determine whether delayed second-procedure targeted intraoperative radiotherapy (TARGIT-IORT) is noninferior to whole-breast external beam radiotherapy (EBRT) in terms of local control. Design, Setting, and Participants In this prospective, randomized (1:1 ratio) noninferiority trial, 1153 patients aged 45 years or older with invasive ductal breast carcinoma smaller than 3.5 cm treated with breast conservation were enrolled from 28 centers in 9 countries. Data were locked in on July 3, 2019. Interventions The TARGIT-A trial was started in March 2000; patients were randomized after needle biopsy to receive TARGIT-IORT immediately after lumpectomy under the same anesthetic vs EBRT and results have been shown to be noninferior. A parallel study, described in this article, was initiated in 2004; patients who had their cancer excised were randomly allocated using separate randomization tables to receive EBRT or delayed TARGIT-IORT given as a second procedure by reopening the lumpectomy wound. Main Outcomes and Measures A noninferiority margin for local recurrence rate of 2.5% at 5 years, and long-term survival outcomes. Results Overall, 581 women (mean [SD] age, 63 [7] years) were randomized to delayed TARGIT-IORT and 572 patients (mean [SD] age, 63 [8] years) were randomized to EBRT. Sixty patients (5%) had tumors larger than 2 cm, or had positive nodes and only 32 (2.7%) were younger than 50 years. Delayed TARGIT-IORT was not noninferior to EBRT. The local recurrence rates at 5-year complete follow-up were: delayed TARGIT-IORT vs EBRT (23/581 [3.96%] vs 6/572 [1.05%], respectively; difference, 2.91%; upper 90% CI, 4.4%). With long-term follow-up (median [IQR], 9.0 [7.5-10.5] years), there was no statistically significant difference in local recurrence-free survival (HR, 0.75; 95% CI, 0.57-1.003; P = .052), mastectomy-free survival (HR, 0.88; 95% CI, 0.65-1.18; P = .38), distant disease-free survival (HR, 1.00; 95% CI, 0.72-1.39; P = .98), or overall survival (HR, 0.96; 95% CI, 0.68-1.35; P = .80). Conclusions and Relevance These long-term data show that despite an increase in the number of local recurrences with delayed TARGIT-IORT, there was no statistically significant decrease in mastectomy-free survival, distant disease-free survival, or overall survival. Trial Registration ISRCTN34086741, ClinicalTrials.gov Identifier: NCT00983684.",2020,"The local recurrence rates at 5-year complete follow-up were: delayed TARGIT-IORT vs EBRT (23/581 [3.96%] vs 6/572 [1.05%], respectively; difference, 2.91%; upper 90% CI, 4.4%).","['1153 patients aged 45 years or older with invasive ductal breast carcinoma smaller than 3.5 cm treated with breast conservation', 'Sixty patients (5%) had tumors larger than 2 cm, or had positive nodes and only 32 (2.7%) were younger than 50 years', 'Early Breast Cancer', '581 women (mean [SD] age, 63 [7] years', 'and 572 patients (mean [SD] age, 63 [8] years', '2004; patients who had their cancer excised']","['EBRT', 'radiotherapy', 'delayed TARGIT-IORT', 'Conventional adjuvant radiotherapy', 'EBRT or delayed TARGIT-IORT given as a second procedure by reopening the lumpectomy wound', 'delayed second-procedure targeted intraoperative radiotherapy (TARGIT-IORT', 'Delayed Targeted Intraoperative Radiotherapy vs Whole-Breast Radiotherapy', 'needle biopsy to receive TARGIT-IORT', 'breast external beam radiotherapy (EBRT']","['mastectomy-free survival', 'Local Recurrence and Survival', 'distant disease-free survival', 'mastectomy-free survival, distant disease-free survival, or overall survival', 'local recurrence rates', 'local recurrence rate', 'number of local recurrences', 'local recurrence-free survival', 'overall survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C1134719', 'cui_str': 'Infiltrating ductular carcinoma'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C3844010', 'cui_str': '3.5'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C4517635', 'cui_str': '2.7'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]","[{'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0338240', 'cui_str': 'Intraoperative radiation therapy'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0242939', 'cui_str': 'Adjuvant Radiotherapy'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0851238', 'cui_str': 'Lumpectomy of breast'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0457102', 'cui_str': 'Whole breast'}, {'cui': 'C0005560', 'cui_str': 'Needle biopsy'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0419095', 'cui_str': 'Teleradiotherapy procedure'}]","[{'cui': 'C0024881', 'cui_str': 'Mastectomy'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0443203', 'cui_str': 'Distant'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C2919733', 'cui_str': 'Surviving free of recurrence of neoplastic disease'}]",1153.0,0.381474,"The local recurrence rates at 5-year complete follow-up were: delayed TARGIT-IORT vs EBRT (23/581 [3.96%] vs 6/572 [1.05%], respectively; difference, 2.91%; upper 90% CI, 4.4%).","[{'ForeName': 'Jayant S', 'Initials': 'JS', 'LastName': 'Vaidya', 'Affiliation': 'Division of Surgery and Interventional Science, University College London, London, United Kingdom.'}, {'ForeName': 'Max', 'Initials': 'M', 'LastName': 'Bulsara', 'Affiliation': 'Division of Surgery and Interventional Science, University College London, London, United Kingdom.'}, {'ForeName': 'Christobel', 'Initials': 'C', 'LastName': 'Saunders', 'Affiliation': 'University of Western Australia School of Surgery, West Australia, Australia.'}, {'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Flyger', 'Affiliation': 'Department of Breast Surgery, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Jeffrey S', 'Initials': 'JS', 'LastName': 'Tobias', 'Affiliation': 'Department of Clinical Oncology, University College London Hospitals, London, United Kingdom.'}, {'ForeName': 'Tammy', 'Initials': 'T', 'LastName': 'Corica', 'Affiliation': 'Department of Radiation Oncology, Sir Charles Gairdner Hospital, Perth, West Australia, Australia.'}, {'ForeName': 'Samuele', 'Initials': 'S', 'LastName': 'Massarut', 'Affiliation': 'Department of Surgery, Centro di Riferimento Oncologico di Aviano (CRO) IRCCS, Aviano, Italy.'}, {'ForeName': 'Frederik', 'Initials': 'F', 'LastName': 'Wenz', 'Affiliation': 'University Medical Center Mannheim, Department of Radiation Oncology, Medical Faculty Mannheim, Heidelberg University, Germany.'}, {'ForeName': 'Steffi', 'Initials': 'S', 'LastName': 'Pigorsch', 'Affiliation': 'Red Cross Hospital, Department of Gynecology and Obstetrics, Technical University of Munich, Munich, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Alvarado', 'Affiliation': 'Department of Surgery, University of California, San Francisco.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Douek', 'Affiliation': 'Nuffield Department of Surgical Sciences, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Eiermann', 'Affiliation': 'Red Cross Hospital, Department of Gynecology and Obstetrics, Technical University of Munich, Munich, Germany.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Brew-Graves', 'Affiliation': 'Division of Surgery and Interventional Science, University College London, London, United Kingdom.'}, {'ForeName': 'Norman', 'Initials': 'N', 'LastName': 'Williams', 'Affiliation': 'Division of Surgery and Interventional Science, University College London, London, United Kingdom.'}, {'ForeName': 'Ingrid', 'Initials': 'I', 'LastName': 'Potyka', 'Affiliation': 'Division of Surgery and Interventional Science, University College London, London, United Kingdom.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Roberts', 'Affiliation': 'Division of Surgery and Interventional Science, University College London, London, United Kingdom.'}, {'ForeName': 'Marcelle', 'Initials': 'M', 'LastName': 'Bernstein', 'Affiliation': 'Patient Advocate and Writer, London, United Kingdom.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Brown', 'Affiliation': 'Department of Surgery, Ninewells Hospital, Dundee, United Kingdom.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Sperk', 'Affiliation': 'University Medical Center Mannheim, Department of Radiation Oncology, Medical Faculty Mannheim, Heidelberg University, Germany.'}, {'ForeName': 'Siobhan', 'Initials': 'S', 'LastName': 'Laws', 'Affiliation': 'Department of Surgery, Royal Hampshire County Hospital, Winchester, United Kingdom.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Sütterlin', 'Affiliation': 'University Medical Center Mannheim, Department of Gynecology and Obstetrics, Medical Faculty Mannheim, Heidelberg University, Germany.'}, {'ForeName': 'Steinar', 'Initials': 'S', 'LastName': 'Lundgren', 'Affiliation': ""Department of Oncology, St Olav's University Hospital, Trondheim, Norway.""}, {'ForeName': 'Dennis', 'Initials': 'D', 'LastName': 'Holmes', 'Affiliation': 'Helen Rey Breast Cancer Foundation, John Wayne Cancer Institute, University of Southern California, Los Angeles.'}, {'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Vinante', 'Affiliation': 'Department of Radiation Oncology, Centro di Riferimento Oncologico di Aviano (CRO) IRCCS, Aviano, Italy.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Bozza', 'Affiliation': 'Instituto Oncologico Veneto, Padoa, Italy.'}, {'ForeName': 'Montserrat', 'Initials': 'M', 'LastName': 'Pazos', 'Affiliation': 'University Hospital, Department of Radiation Oncology, Ludwig Maximilians Universitat, Munich, Germany.'}, {'ForeName': 'Magali', 'Initials': 'M', 'LastName': 'Le Blanc-Onfroy', 'Affiliation': ""Oncologue radiothérapeute, Institut de Cancérologie de l'Ouest, Nantes, France.""}, {'ForeName': 'Günther', 'Initials': 'G', 'LastName': 'Gruber', 'Affiliation': 'Brust Zentrum Seefeld, Zurich, Zurich, Switzerland.'}, {'ForeName': 'Wojciech', 'Initials': 'W', 'LastName': 'Polkowski', 'Affiliation': 'Department of Surgical Oncology, Medical University of Lublin, Lublin, Poland.'}, {'ForeName': 'Konstantin J', 'Initials': 'KJ', 'LastName': 'Dedes', 'Affiliation': 'Breast Center, Universitätsspital Zürich, Zurich, Switzerland.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Niewald', 'Affiliation': 'Saarland University Medical Center, Homberg, Germany.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Blohmer', 'Affiliation': 'Sankt Gertrauden-Krankenhaus, and The Charité - Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'McCready', 'Affiliation': 'Princess Margaret Cancer Centre Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Hoefer', 'Affiliation': 'Sentara Surgery Specialists, Hampton, Virginia.'}, {'ForeName': 'Pond', 'Initials': 'P', 'LastName': 'Kelemen', 'Affiliation': 'Ashikari Breast Center, New York Medical College, New York, New York.'}, {'ForeName': 'Gloria', 'Initials': 'G', 'LastName': 'Petralia', 'Affiliation': 'Department of Surgery, University College London Hospitals, London, United Kingdom.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Falzon', 'Affiliation': 'Department of Pathology, University College London Hospitals, London, United Kingdom.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Baum', 'Affiliation': 'Division of Surgery and Interventional Science, University College London, London, United Kingdom.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Joseph', 'Affiliation': 'Department of Radiation Oncology, Sir Charles Gairdner Hospital, Perth, West Australia, Australia.'}]",JAMA oncology,['10.1001/jamaoncol.2020.0249'] 457,32052217,Obesity and efficacy of vitamin D 3 supplementation in healthy black adults.,"PURPOSE Results from recent clinical trials suggest that vitamin D efficacy against cancer may be influenced by body mass index. As suppression of parathyroid hormone (PTH) is one indicator of vitamin D efficacy, we examined to what extent doses of vitamin D 3 supplementation suppress PTH levels in individuals with and without obesity. METHODS A total of 328 healthy African Americans were randomized into the following four groups and treated for 3 months: placebo, 1,000, 2,000, or 4,000 IU/day of vitamin D 3 supplementation. RESULTS Among the participants, 250 individuals with PTH measurements were included in the analysis. Obese individuals (n = 141) experienced a steep reduction of 3-month PTH from placebo to 1,000 IU/day of vitamin D 3 supplementation, but no further reduction at 2,000 or 4,000 IU/day. For non-obese individuals (n = 109), the reduction of 3-month PTH was approximately linear for increasing vitamin D 3 doses. At supplementation of 2,000 to 4,000 IU/day, 3-month 25(OH)vitamin D levels were high in both non-obese and obese individuals, but the 3-month PTH levels remained about 10 pg/mL higher in individuals with obesity. CONCLUSION Our findings suggest that excess adiposity confers resistance to vitamin D efficacy in suppressing PTH levels, even when given at high doses.",2020,"Obese individuals (n = 141) experienced a steep reduction of 3-month PTH from placebo to 1,000 IU/day of vitamin D 3 supplementation, but no further reduction at 2,000 or 4,000 IU/day.","['250 individuals with PTH measurements', 'individuals with and without obesity', 'healthy black adults', 'Obese individuals (n\u2009=\u2009141', '328 healthy African Americans']","['placebo', 'vitamin D 3 supplementation']","['Obesity and efficacy', 'reduction of 3-month PTH', '3-month PTH levels']","[{'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0202159', 'cui_str': 'Parathyroid hormone measurement (procedure)'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4517572', 'cui_str': 'One hundred and forty-one'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}]","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0202159', 'cui_str': 'Parathyroid hormone measurement (procedure)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",328.0,0.276674,"Obese individuals (n = 141) experienced a steep reduction of 3-month PTH from placebo to 1,000 IU/day of vitamin D 3 supplementation, but no further reduction at 2,000 or 4,000 IU/day.","[{'ForeName': 'Hanseul', 'Initials': 'H', 'LastName': 'Kim', 'Affiliation': 'Department of Epidemiology, Harvard T.H. Chan School of Public Health, Boston, MA, 02115, USA.'}, {'ForeName': 'Paulette', 'Initials': 'P', 'LastName': 'Chandler', 'Affiliation': ""Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, 02115, USA.""}, {'ForeName': 'Kimmie', 'Initials': 'K', 'LastName': 'Ng', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, 02215, USA.'}, {'ForeName': 'JoAnn E', 'Initials': 'JE', 'LastName': 'Manson', 'Affiliation': 'Department of Epidemiology, Harvard T.H. Chan School of Public Health, Boston, MA, 02115, USA.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Giovannucci', 'Affiliation': 'Department of Epidemiology, Harvard T.H. Chan School of Public Health, Boston, MA, 02115, USA. egiovann@hsph.harvard.edu.'}]",Cancer causes & control : CCC,['10.1007/s10552-020-01275-3'] 458,32233959,Immunogenicity and safety of a quadrivalent meningococcal tetanus toxoid-conjugate vaccine (MenACYW-TT) in healthy toddlers: a Phase II randomized study.,"NEISSERIA MENINGITIDIS can lead to invasive meningococcal disease to which young children are particularly vulnerable. We assessed the immunogenicity and safety of Sanofi Pasteur's investigational quadrivalent (serogroups A, C, Y, and W) meningococcal tetanus-toxoid conjugate vaccine, MenACYW-TT, as a single dose, in healthy meningococcal vaccine-naïve toddlers versus a licensed conjugate vaccine MCV4-TT (NCT03205358). In this Phase II study conducted in Finland, 188 toddlers aged 12-24 months were randomized 1:1 to MenACYW-TT or MCV4-TT. Serum bactericidal antibody assays using human complement (hSBA) and baby rabbit complement (rSBA) measured antibodies against each serogroup before and 30 days after vaccination. Participants were monitored for immediate adverse events (AEs) and post-vaccination AEs for 30 days. All analyses were descriptive. All 188 participants completed the study. The Day 30 hSBA seroresponses (hSBA titer <8 at baseline and post-vaccination titer ≥8, or ≥8 at baseline and ≥4-fold increase post-vaccination) were comparable between participants receiving MenACYW-TT (96.7-100%), and MCV4-TT (86.0-100.0%) for each serogroup. Most unsolicited AEs were of Grade 1 or Grade 2 intensity. There were no immediate hypersensitivity reactions, and no AEs or serious AEs leading to discontinuation from the study. In this exploratory study, MenACYW-TT vaccine was well tolerated and immunogenic. If confirmed in Phase III, a single dose of the MenACYW-TT vaccine may show promise as an alternative vaccine option for toddlers receiving meningococcal vaccination for the first time.",2020,"There were no immediate hypersensitivity reactions, and no AEs or serious AEs leading to discontinuation from the study.","['All 188 participants completed the study', 'healthy meningococcal vaccine-naïve toddlers', 'healthy toddlers', '188 toddlers aged 12-24\xa0months']","['quadrivalent meningococcal tetanus toxoid-conjugate vaccine (MenACYW-TT', 'MCV4-TT']","['tolerated and immunogenic', 'immediate hypersensitivity reactions', 'Immunogenicity and safety', 'immunogenicity and safety', 'immediate adverse events (AEs) and post-vaccination AEs']","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0700144', 'cui_str': 'Meningococcus vaccine'}, {'cui': 'C0682053', 'cui_str': 'Toddler'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0127526', 'cui_str': 'Meningococcal polysaccharide vaccine'}, {'cui': 'C0039620', 'cui_str': 'Tetanus vaccine'}, {'cui': 'C0206515', 'cui_str': 'Vaccines, Conjugate'}]","[{'cui': 'C0020523', 'cui_str': 'IgE-mediated allergic disorder'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]",188.0,0.211319,"There were no immediate hypersensitivity reactions, and no AEs or serious AEs leading to discontinuation from the study.","[{'ForeName': 'Timo', 'Initials': 'T', 'LastName': 'Vesikari', 'Affiliation': 'Vaccine Research Center, University of Tampere , Tampere, Finland.'}, {'ForeName': 'Ray', 'Initials': 'R', 'LastName': 'Borrow', 'Affiliation': 'Vaccine Evaluation Unit, Public Health England , Manchester, UK.'}, {'ForeName': 'Aino', 'Initials': 'A', 'LastName': 'Forsten', 'Affiliation': 'Vaccine Research Center, University of Tampere , Tampere, Finland.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Findlow', 'Affiliation': 'Vaccine Evaluation Unit, Public Health England , Manchester, UK.'}, {'ForeName': 'Mandeep S', 'Initials': 'MS', 'LastName': 'Dhingra', 'Affiliation': 'Global Clinical Sciences, Sanofi Pasteur , Swiftwater, PA, USA.'}, {'ForeName': 'Emilia', 'Initials': 'E', 'LastName': 'Jordanov', 'Affiliation': 'Global Clinical Sciences, Sanofi Pasteur , Swiftwater, PA, USA.'}]",Human vaccines & immunotherapeutics,['10.1080/21645515.2020.1733869'] 459,32233961,Immunogenicity and safety of a quadrivalent meningococcal tetanus toxoid-conjugate vaccine (MenACYW-TT) in adults 56 years of age and older: a Phase II randomized study.,"MenACYW-TT is an investigational quadrivalent meningococcal conjugate vaccine intended for the prevention of invasive meningococcal disease (IMD) caused by serogroups A, C, W, and Y in individuals aged 6 weeks and above. This Phase II, randomized, open-label, multicenter, exploratory study assessed the safety and immunogenicity of MenACYW-TT compared with a quadrivalent meningococcal polysaccharide vaccine (MPSV4) in 301 healthy adults aged ≥56 y in the US (NCT01732627). Participants were randomized 2:1 to receive MenACYW-TT or MPSV4. Serum bactericidal assays using human (hSBA) or baby rabbit (rSBA) complement were used to measure functional antibodies against meningococcal serogroups A, C, W, and Y at baseline and 30 d post-vaccination. Safety data were collected up to 30 d post-vaccination. Proportions of study participants with hSBA titers ≥1:8 against serogroups A, C, W, and Y were increased at Day 30 compared with baseline in both vaccine groups. The proportions of participants with hSBA titers ≥1:8 after MenACYW-TT vaccination were comparable to those after MPSV4 vaccination for serogroups A and C (A: 93.8% vs. 85.1%; C: 74.9% vs. 62.8%) and distinctly higher than after MPSV4 for serogroups W and Y (W: 79.5% vs. 60.6%; Y: 80.5% vs. 59.6%). Proportions of participants with rSBA titers ≥1:8 were comparable between vaccine groups for all four serogroups. The reactogenicity profiles of both vaccines were similar. Most unsolicited adverse events (AEs) were of Grade 1 or Grade 2 intensity, and no serious AEs were reported. The MenACYW-TT conjugate vaccine was well tolerated and immunogenic in adults aged ≥56 y.",2020,The MenACYW-TT conjugate vaccine was well tolerated and immunogenic in adults aged ≥56 ,"['adults 56 years of age and older', 'adults aged ≥56', '301 healthy adults aged ≥56\xa0y in the US (NCT01732627']","['quadrivalent meningococcal tetanus toxoid-conjugate vaccine (MenACYW-TT', 'Serum bactericidal assays using human (hSBA) or baby rabbit (rSBA', 'quadrivalent meningococcal polysaccharide vaccine (MPSV4', 'MenACYW-TT or MPSV4']","['Immunogenicity and safety', 'safety and immunogenicity', 'tolerated and immunogenic']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C0127526', 'cui_str': 'Meningococcal polysaccharide vaccine'}, {'cui': 'C0039620', 'cui_str': 'Tetanus vaccine'}, {'cui': 'C0206515', 'cui_str': 'Vaccines, Conjugate'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0005507', 'cui_str': 'Bioassay'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0324889', 'cui_str': 'Oryctolagus cuniculus'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}]",301.0,0.147645,The MenACYW-TT conjugate vaccine was well tolerated and immunogenic in adults aged ≥56 ,"[{'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Kirstein', 'Affiliation': 'Advanced Clinical Research , West Jordan, UT, USA.'}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Pina', 'Affiliation': 'Clinical Development, Sanofi Pasteur , Swiftwater, PA, USA.'}, {'ForeName': 'Judy', 'Initials': 'J', 'LastName': 'Pan', 'Affiliation': 'Clinical Development, Sanofi Pasteur , Swiftwater, PA, USA.'}, {'ForeName': 'Emilia', 'Initials': 'E', 'LastName': 'Jordanov', 'Affiliation': 'Clinical Development, Sanofi Pasteur , Swiftwater, PA, USA.'}, {'ForeName': 'Mandeep S', 'Initials': 'MS', 'LastName': 'Dhingra', 'Affiliation': 'Clinical Development, Sanofi Pasteur , Swiftwater, PA, USA.'}]",Human vaccines & immunotherapeutics,['10.1080/21645515.2020.1733868'] 460,31721257,"A randomized, placebo-controlled crossover trial of phentermine-topiramate ER in patients with binge-eating disorder and bulimia nervosa.","OBJECTIVE Open trials suggest phentermine/topiramate ER (PHEN/TPM-ER), food and drug administration (FDA) approved for obesity, has utility for binge eating. With no randomized controlled trials (RCTs) yet performed, this trial aimed to evaluate PHEN/TPM-ERs efficacy and safety in a crossover RCT for patients with binge-eating disorder (BED) or bulimia nervosa (BN). METHOD Participants were randomized to 12-weeks PHEN/TPM-ER (3.75 mg/23 mg-15 mg/92 mg) or placebo followed by 2-weeks drug washout, then 12-week crossover. Demographics, vitals, eating disorder behaviors, mood, and side effects were measured. Primary outcome was objective binge-eating (OBE) days/4-weeks; secondary outcomes included binge abstinence. Mixed-effect models estimated treatment effects, with fixed effects adjusting for treatment, study period, and diagnosis. RESULTS The 22 adults (BED = 18, BN = 4) were female (96%), Caucasian (55%), aged 42.9 (SD = 10.1) years with body mass index = 31.1 (SD = 6.2) kg/m 2 . Baseline OBE days/4-weeks decreased from 16.2 (SD = 7.8) to 4.2 (SD = 8.4) after PHEN/TPM-ER versus 13.2 (SD = 9.1) after placebo (p < .0001), with abstinence rates = 63.6% on PHEN/TPM-ER versus 9.1% on placebo (p < .0001). Weight changes = -5.8 kg on PHEN/ TPM-ER versus +0.4 kg on placebo. Drop-out = 2 (9%) on PHEN/TPM-ER and 2 (9%) on placebo, with few side effects. Vital sign changes with PHEN/TPM-ER were minimal and similar to placebo. Responses were not significantly different for BED versus BN. DISCUSSION This first RCT to evaluate the efficacy and safety of PHEN/TPM-ER for BED/BN found this drug combination significantly more effective at reducing binge eating than placebo and well tolerated. However, with only four participants with BN, findings regarding the safety of PHEN/TPM-ER in patients with BN must be taken with caution. TRIAL REGISTRATION Clinicaltrials.gov identifier NCT02553824 registered on 9/17/2015. https://clinicaltrials.gov/ct2/show/NCT02553824.",2020,63.6% on PHEN/TPM-ER versus 9.1% on placebo (p < .0001).,"['Participants', 'patients with binge-eating disorder and bulimia nervosa', 'patients with binge-eating disorder (BED) or bulimia nervosa (BN', '3.75\u2009mg/23', '22 adults (BED = 18, BN = 4) were female (96%), Caucasian (55%), aged 42.9 (SD = 10.1) years with body mass index = 31.1 (SD = 6.2) kg/m 2 ']","['RCT', 'placebo', 'phentermine-topiramate ER', 'phentermine/topiramate ER (PHEN/TPM-ER), Food and Drug Administration (FDA', 'PHEN/TPM-ER']","['objective binge-eating (OBE) days/4-weeks; secondary outcomes included binge abstinence', 'Demographics, vitals, eating disorder behaviors, mood, and side effects', 'Baseline OBE days/4-weeks', 'tolerated', 'binge eating', 'safety of PHEN/TPM-ER']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0596170', 'cui_str': 'Binge overeating'}, {'cui': 'C2267227', 'cui_str': 'Bulimia Nervosa'}, {'cui': 'C4517697', 'cui_str': 'Three point seven five'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0004916', 'cui_str': 'Beds'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C4517773', 'cui_str': 'Forty-two point nine'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517820', 'cui_str': '6.2'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0031447', 'cui_str': 'Phentermine'}, {'cui': 'C0076829', 'cui_str': 'topiramate'}, {'cui': 'C3475162', 'cui_str': 'Phentermine / topiramate'}, {'cui': 'C0041714', 'cui_str': 'Food and Drug Administration'}]","[{'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0596170', 'cui_str': 'Binge overeating'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0442732', 'cui_str': 'Vital (qualifier value)'}, {'cui': 'C0013473', 'cui_str': 'Eating Disorders'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.663233,63.6% on PHEN/TPM-ER versus 9.1% on placebo (p < .0001).,"[{'ForeName': 'Debra L', 'Initials': 'DL', 'LastName': 'Safer', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, Stanford, California.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Adler', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, Stanford, California.'}, {'ForeName': 'Shebani Sethi', 'Initials': 'SS', 'LastName': 'Dalai', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, Stanford, California.'}, {'ForeName': 'Jason P', 'Initials': 'JP', 'LastName': 'Bentley', 'Affiliation': 'Quantitative Sciences Unit, Stanford University School of Medicine, Stanford, California.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Toyama', 'Affiliation': 'Department of Psychology, Palo Alto University, Palo Alto, California.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Pajarito', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, Stanford, California.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Najarian', 'Affiliation': 'Najarian Center for Obesity, Los Osos, California.'}]",The International journal of eating disorders,['10.1002/eat.23192'] 461,32238920,Ki-67 response-guided preoperative chemotherapy for HER2-positive breast cancer: results of a randomised Phase 2 study.,"BACKGROUND The effectiveness of a therapeutic strategy that switches chemotherapy, based on Ki-67 tumour expression after initial therapy, relative to that of standard chemotherapy, has not been evaluated. METHODS Patients were randomly assigned to the control arm or the Ki-67 response-guided arm (Ki-67 arm). Primary tumour biopsies were obtained before treatment, and after three once-weekly doses of paclitaxel and trastuzumab to assess the interim Ki-67 index. In the control arm, paclitaxel and trastuzumab were continued for a total of 12 doses, regardless of the interim Ki-67 index. In the Ki-67 arm, subsequent treatment was based on the interim Ki-67 index. Ki-67 early responder is defined as the absolute Ki-67 value that was <10%, and the percentage of Ki-67-positive tumour cells was reduced by >30% compared with before treatment. Early Ki-67 responders continued to receive the same treatment, while early Ki-67 non-responders were switched to epirubicin plus cyclophosphamide. The primary endpoint was the pathological complete response (pCR) rate. RESULTS A total of 237 patients were randomised. There was almost linear correlation between the Ki-67 reduction rate at interim assessment and the pCR rate. The pCR rate in Ki-67 early non-responders in the Ki-67 arm was inferior to that in the control arm (44.1%; 31.4-56.7; P = 0.025). CONCLUSIONS The standard chemotherapy protocol remains as the recommended strategy for patients with HER2-positive breast cancer. CLINICAL TRIAL REGISTRATION Clinical Trial Registration: UMIN-CTR as UMIN000007074.",2020,"The pCR rate in Ki-67 early non-responders in the Ki-67 arm was inferior to that in the control arm (44.1%; 31.4-56.7; P = 0.025). ","['patients with HER2-positive breast cancer', '237 patients were randomised', 'HER2-positive breast cancer', 'Patients']","['paclitaxel and trastuzumab', 'Ki-67 response-guided preoperative chemotherapy', 'epirubicin plus cyclophosphamide', 'Ki-67 response-guided arm (Ki-67 arm']","['pathological complete response (pCR) rate', 'absolute Ki-67 value', 'pCR rate', 'Ki-67 reduction rate', 'percentage of Ki-67-positive tumour cells']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1960398', 'cui_str': 'HER2-positive carcinoma of breast'}]","[{'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0014582', 'cui_str': 'Epirubicin'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]","[{'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0032520', 'cui_str': 'Polymerase chain reaction'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0431085', 'cui_str': 'Tumor cells, uncertain whether benign or malignant'}]",237.0,0.0497755,"The pCR rate in Ki-67 early non-responders in the Ki-67 arm was inferior to that in the control arm (44.1%; 31.4-56.7; P = 0.025). ","[{'ForeName': 'Hirofumi', 'Initials': 'H', 'LastName': 'Mukai', 'Affiliation': 'National Cancer Center Hospital East, Kashiwa, Chiba, 277-8577, Japan. hrmukai@east.ncc.go.jp.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Yamaguchi', 'Affiliation': 'Musashino Red Cross Hospital, Musashino, Tokyo, 180-0023, Japan.'}, {'ForeName': 'Masato', 'Initials': 'M', 'LastName': 'Takahashi', 'Affiliation': 'National Hospital Organization Hokkaido Cancer Center, Sapporo, Hokkaido, 003-0804, Japan.'}, {'ForeName': 'Yasuo', 'Initials': 'Y', 'LastName': 'Hozumi', 'Affiliation': 'University of Tsukuba Hospital, Tsukuba, Ibaraki, 305-8576, Japan.'}, {'ForeName': 'Tomomi', 'Initials': 'T', 'LastName': 'Fujisawa', 'Affiliation': 'Gunma Prefectural Cancer Center, Ota, Gunma, 373-0828, Japan.'}, {'ForeName': 'Shozo', 'Initials': 'S', 'LastName': 'Ohsumi', 'Affiliation': 'National Hospital Organization Shikoku Cancer Center, Matsuyama, Ehime, 791-0245, Japan.'}, {'ForeName': 'Hiromitsu', 'Initials': 'H', 'LastName': 'Akabane', 'Affiliation': 'Asahikawa-Kosei General Hospital, Hokkaido, Asahikawa, Japan.'}, {'ForeName': 'Reiki', 'Initials': 'R', 'LastName': 'Nishimura', 'Affiliation': 'Kumamoto Shinto General Hospital, Chuo Ward, Kumamoto, 862-8655, Japan.'}, {'ForeName': 'Tsutomu', 'Initials': 'T', 'LastName': 'Takashima', 'Affiliation': 'Osaka City University Graduate School of Medicine, Sumiyoshi Ward, Osaka, 558-0022, Japan.'}, {'ForeName': 'Youngjin', 'Initials': 'Y', 'LastName': 'Park', 'Affiliation': 'Tohoku Medical and Pharmaceutical University Hospital, Sendai, Miyagi, 981-8558, Japan.'}, {'ForeName': 'Yasuaki', 'Initials': 'Y', 'LastName': 'Sagara', 'Affiliation': 'Hakuaikai Medical Corp Sagara Hospital, Kagoshima, Japan.'}, {'ForeName': 'Tatsuya', 'Initials': 'T', 'LastName': 'Toyama', 'Affiliation': 'Nagoya City University Graduate School of Medical Sciences, Aichi, Nagoya, 467-8601, Japan.'}, {'ForeName': 'Shigeru', 'Initials': 'S', 'LastName': 'Imoto', 'Affiliation': 'Kyorin University Hospital, Mitaka, Tokyo, 181-8611, Japan.'}, {'ForeName': 'Toshiro', 'Initials': 'T', 'LastName': 'Mizuno', 'Affiliation': 'Mie University Hospital, Tsu, Mie, 514-8507, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Yamashita', 'Affiliation': 'National Cancer Center Research Institute, Chuo-ku, Tokyo, 104-0045, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Fujii', 'Affiliation': 'Division of Pathology, Exploratory Oncology Research & Clinical Trial Center, National Cancer Center, Kashiwa, Chiba, 277-8577, Japan.'}, {'ForeName': 'Yukari', 'Initials': 'Y', 'LastName': 'Uemura', 'Affiliation': 'National Center for Global Health and Medicine, Tokyo, Japan.'}]",British journal of cancer,['10.1038/s41416-020-0815-9'] 462,32237005,A behavioral economics-based telehealth intervention to improve aspirin adherence following hospitalization for acute coronary syndrome.,"PURPOSE A significant number of patients with acute coronary syndrome (ACS) are nonadherent to aspirin after hospital discharge, with an associated increased risk of subsequent cardiovascular events. The purpose of this pilot study was to test the efficacy of a telehealth intervention based on behavioral economics to improve aspirin adherence following hospitalization for ACS. METHODS We enrolled 130 participants (c¯X = 58 ± 10.7 years of age, 38% female, 45% black) from two hospitals. Patients were eligible if they owned a smartphone and were admitted to the hospital for ACS, prescribed aspirin at discharge, and responsible for administering their own medications. Consenting participants were randomized to the intervention or usual care group. The intervention group was eligible to receive up to $50 per month if they took their medicine daily, with $2 per day deducted if a dose was missed. All participants received an electronic monitoring (EM) pill bottle containing a 90-day supply of aspirin, which was used to measure adherence calculated as the proportion of prescribed drug taken using the EM device. Based on the skewness in the adherence distribution, quantile regression was used to evaluate the effect of the intervention on median adherence over time. RESULTS After 90 days, adherence fell in the control group but remained high in the intervention group (median adherence 81% vs 90%, P = .18). Rehospitalization was higher in the control group (24% vs 13%, P = .17). CONCLUSION A loss aversion behavioral economics-based telehealth intervention is a promising approach to improving aspirin adherence following hospitalization for ACS.",2020,"Rehospitalization was higher in the control group (24% vs 13%, P = .17). ","['acute coronary syndrome', 'Patients were eligible if they owned a smartphone and were admitted to the hospital for ACS, prescribed aspirin at discharge, and responsible for administering their own medications', 'patients with acute coronary syndrome (ACS', '130 participants (c¯X = 58\u2009±\u200910.7\u2009years of age, 38% female, 45% black) from two hospitals', 'Consenting participants']","['aspirin', 'intervention or usual care group', 'behavioral economics-based telehealth intervention', 'electronic monitoring (EM) pill bottle containing a 90-day supply of aspirin', 'telehealth intervention']","['Rehospitalization', 'aspirin adherence', 'median adherence over time', 'adherence fell']","[{'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C2239117', 'cui_str': 'Prescription of drug'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C3871203', 'cui_str': 'At discharge'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0002455', 'cui_str': 'American Cancer Society'}, {'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C5191365', 'cui_str': '10.7'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C2711213', 'cui_str': 'Consented'}]","[{'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0013556', 'cui_str': 'Economics'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0336646', 'cui_str': 'Electronic monitor'}, {'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}, {'cui': 'C0179376', 'cui_str': 'Bottle'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}]","[{'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}]",130.0,0.040123,"Rehospitalization was higher in the control group (24% vs 13%, P = .17). ","[{'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Riegel', 'Affiliation': 'School of Nursing at the University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Alisa', 'Initials': 'A', 'LastName': 'Stephens-Shields', 'Affiliation': 'Department of Biostatistics, Epidemiology and Informatics, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Jaskowiak-Barr', 'Affiliation': 'Department of Biostatistics, Epidemiology and Informatics, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Marguerite', 'Initials': 'M', 'LastName': 'Daus', 'Affiliation': 'School of Nursing at the University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Stephen E', 'Initials': 'SE', 'LastName': 'Kimmel', 'Affiliation': 'Department of Biostatistics, Epidemiology and Informatics, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania.'}]",Pharmacoepidemiology and drug safety,['10.1002/pds.4988'] 463,30664661,Psychiatric adverse events and effects on mood with prolonged-release naltrexone/bupropion combination therapy: a pooled analysis.,"BACKGROUND/OBJECTIVES Prolonged-release (PR) naltrexone 32 mg/bupropion 360 mg (NB) is approved for chronic weight management as an adjunct to reduced-calorie diet and increased physical activity. Central nervous system-active medications have the potential to affect mood; therefore, post hoc analysis of clinical trial data was conducted to evaluate psychiatric adverse events (PAEs) and effects on mood of NB therapy versus placebo. SUBJECTS/METHODS Data were pooled from 5 prospective, double-blind, randomized, placebo-controlled clinical trials (duration range, 24-56 weeks) of NB in subjects with overweight or obesity. PAEs were collected via AE preferred terms, organized into major subtopics (e.g., anxiety, depression, sleep disorders), and divided into category terms (e.g., anxiety, potential anxiety symptoms). Additionally, the Inventory of Depressive Symptomatology Self Report (IDS-SR; score range 0-84) and the Columbia Classification Algorithm of Suicide Assessment (C-CASA) evaluated treatment-emergent depressive/anxiety symptoms and suicidal behavior/ideation, respectively. RESULTS Baseline characteristics and comorbidities were comparable for placebo (n = 1515) and NB (n = 2545). Most common PAEs in the NB group (using category grouping; NB vs placebo) were sleep disorders (12.7 vs 7.9%, P < 0.001), anxiety (5.4 vs 3.3%, P = 0.029), and depression (1.8 vs 2.7%, P = 0.014); PAEs were more frequent during dose escalation and generally mild or moderate. Mean (SD) changes in IDS-SR total score from baseline to endpoint were small in both groups: 0.13 (5.83) for NB and -0.45 (5.65) for placebo. Retrospective AE categorization via C-CASA confirmed no completed suicides, suicide attempts, or preparatory acts toward imminent suicidal behavior. CONCLUSIONS This large pooled analysis of 5 clinical trials provides additional safety information about the NB PAE profile. Anxiety and sleep disorder-related PAEs were more frequent with NB versus placebo but were mostly mild to moderate and generally occurred early. Depression-related PAEs were less common with NB than placebo, and NB was not associated with suicidal ideation or behavior in this patient population.",2019,"Depression-related PAEs were less common with NB than placebo, and NB was not associated with suicidal ideation or behavior in this patient population.",['subjects with overweight or obesity'],"['naltrexone/bupropion combination therapy', 'bupropion 360\u2009mg (NB', 'placebo']","['Depression-related PAEs', 'depression', 'suicidal ideation or behavior', 'Inventory of Depressive Symptomatology Self Report (IDS-SR; score range 0-84) and the Columbia Classification Algorithm of Suicide Assessment (C-CASA) evaluated treatment-emergent depressive/anxiety symptoms and suicidal behavior/ideation, respectively', 'Psychiatric adverse events', 'Mean (SD) changes in IDS-SR total score', 'Anxiety and sleep disorder-related PAEs', 'anxiety', 'sleep disorders']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0027360', 'cui_str': 'Naltrexone'}, {'cui': 'C0085208', 'cui_str': 'Bupropion'}, {'cui': 'C0556895', 'cui_str': 'Combination therapy (regime/therapy)'}, {'cui': 'C4319607', 'cui_str': '360 (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0424000', 'cui_str': 'Suicidal Ideation'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0008903', 'cui_str': 'taxonomy'}, {'cui': 'C0002045'}, {'cui': 'C3494753', 'cui_str': 'Suicide evaluation'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C1760428', 'cui_str': 'Suicidal behavior (finding)'}, {'cui': 'C0392348', 'cui_str': 'Ideation, function (observable entity)'}, {'cui': 'C0205487', 'cui_str': 'Psychiatric (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0851578', 'cui_str': 'Sleep Disorders'}]",,0.497082,"Depression-related PAEs were less common with NB than placebo, and NB was not associated with suicidal ideation or behavior in this patient population.","[{'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Pi-Sunyer', 'Affiliation': 'Columbia University Medical Center, New York, NY, USA.'}, {'ForeName': 'Caroline M', 'Initials': 'CM', 'LastName': 'Apovian', 'Affiliation': 'Boston University School of Medicine and Department of Medicine Section of Endocrinology, Diabetes and Nutrition, Boston Medical Center, Boston, MA, USA.'}, {'ForeName': 'Susan L', 'Initials': 'SL', 'LastName': 'McElroy', 'Affiliation': 'Lindner Center of HOPE, Mason, and Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, Cincinnati, OH, USA.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Dunayevich', 'Affiliation': 'Annexon Biosciences, South San Francisco, CA, USA.'}, {'ForeName': 'Lisette M', 'Initials': 'LM', 'LastName': 'Acevedo', 'Affiliation': 'Nalpropion Pharmaceuticals, Inc, La Jolla, CA, USA.'}, {'ForeName': 'Frank L', 'Initials': 'FL', 'LastName': 'Greenway', 'Affiliation': 'Pennington Biomedical Research Center, Louisiana State University, Baton Rouge, LA, USA. frank.greenway@pbrc.edu.'}]",International journal of obesity (2005),['10.1038/s41366-018-0302-z'] 464,31821220,"Psychological Function, Iyengar Yoga, and Coherent Breathing: A Randomized Controlled Dosing Study.","BACKGROUND Evidence suggests that yoga may be an effective treatment for major depressive disorder (MDD). Studies evaluating the ""dosing"" of yoga treatment and efficacy for MDD are needed. The goal of this study was to assess the effects of an intervention combining Iyengar yoga and coherent breathing in participants with MDD and determine the optimal intervention dose. METHODS Thirty-two participants (18 to 65 y of age) diagnosed with MDD were randomized to a high-dose group (HDG) or a low-dose group (LDG) of yoga and coherent breathing for 12 weeks. The HDG (n=15) involved three 90-minute yoga classes and four 30-minute homework sessions per week. The LDG (n=15) involved two 90-minute yoga classes and three 30-minute homework sessions per week. Participants were evaluated at baseline, week 4, week 8, and week 12 with the following instruments: Positivity Self-Test, Spielberger State Anxiety Inventory, Patient Health Questionnaire-9, Pittsburgh Sleep Quality Index, and Exercise-induced Feeling Inventory. Data were analyzed using intent-to-treat methods. RESULTS Significant improvements in all outcome measures were found for both groups, with acute and cumulative benefits. Although the HDG showed greater improvements on all scales, between-group differences did not reach significance, possibly due to lack of power because of the small sample size. Cumulative yoga minutes were correlated with improvement in outcome measures. LIMITATION This dosing study did not include a non-yoga control. CONCLUSIONS Improvement in psychological symptoms correlated with cumulative yoga practice. Both interventions reduced symptoms of depression and anxiety and increased feelings of positivity. The time commitment for yoga practice needs to be weighed against benefits when designing yoga interventions.",2019,"Although the HDG showed greater improvements on all scales, between-group differences did not reach significance, possibly due to lack of power because of the small sample size.","['Thirty-two participants (18 to 65\u2009y of age) diagnosed with MDD', 'participants with MDD and determine the optimal intervention dose', 'major depressive disorder (MDD']","['LDG', 'intervention combining Iyengar yoga and coherent breathing', 'HDG', 'high-dose group (HDG) or a low-dose group (LDG) of yoga and coherent breathing', 'Psychological Function, Iyengar Yoga, and Coherent Breathing']","['symptoms of depression and anxiety and increased feelings of positivity', 'Positivity Self-Test, Spielberger State Anxiety Inventory, Patient Health Questionnaire-9, Pittsburgh Sleep Quality Index, and Exercise-induced Feeling Inventory']","[{'cui': 'C0450357', 'cui_str': '32 (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}]","[{'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0035203', 'cui_str': 'Breathing'}, {'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0233398', 'cui_str': 'Psychological function'}]","[{'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C3697468', 'cui_str': 'PSQI - Pittsburgh sleep quality index'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}]",32.0,0.0762643,"Although the HDG showed greater improvements on all scales, between-group differences did not reach significance, possibly due to lack of power because of the small sample size.","[{'ForeName': 'Tammy M', 'Initials': 'TM', 'LastName': 'Scott', 'Affiliation': 'SCOTT: Department of Psychiatry, Boston University School of Medicine, and Department of Psychiatry, Boston Medical Center, Friedman School of Nutrition Science and Policy, Tufts University, and Tufts University School of Medicine, Boston, MA GERBARG: Department of Psychiatry, New York Medical College, Valhalla, NY SILVERI: Department of Psychiatry, Harvard School of Medicine, Boston, MA, and Department of Psychiatry, McLean Hospital, Belmont, MA NIELSEN and OWEN: Departments of Psychiatry and Neurology, Boston University School of Medicine, Boston, MA NYER: Department of Psychiatry, Harvard School of Medicine, and Department of Psychiatry, Massachusetts General Hospital, Boston, MA BROWN: Department of Psychiatry, Columbia University College of Physicians and Surgeons, New York, NY STREETER: Departments of Psychiatry and Neurology, Boston University School of Medicine, Department of Psychiatry, Harvard School of Medicine, and Department of Psychiatry, Boston Medical Center, Boston, MA, Department of Psychiatry, McLean Hospital, Belmont, MA, and Department of Psychiatry, Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA.'}, {'ForeName': 'Patricia L', 'Initials': 'PL', 'LastName': 'Gerbarg', 'Affiliation': ''}, {'ForeName': 'Marisa M', 'Initials': 'MM', 'LastName': 'Silveri', 'Affiliation': ''}, {'ForeName': 'Greylin H', 'Initials': 'GH', 'LastName': 'Nielsen', 'Affiliation': ''}, {'ForeName': 'Liz', 'Initials': 'L', 'LastName': 'Owen', 'Affiliation': ''}, {'ForeName': 'Maren', 'Initials': 'M', 'LastName': 'Nyer', 'Affiliation': ''}, {'ForeName': 'Richard P', 'Initials': 'RP', 'LastName': 'Brown', 'Affiliation': ''}, {'ForeName': 'Chris C', 'Initials': 'CC', 'LastName': 'Streeter', 'Affiliation': ''}]",Journal of psychiatric practice,['10.1097/PRA.0000000000000435'] 465,30793375,Comparing web-based video interventions to enhance university student willingness to donate organs: A randomized controlled trial.,"BACKGROUND The efficacy of video interventions to increase organ donation willingness remains unclear. METHODS Three-arm web-based randomized controlled trial involving 2261 students at 3 northeastern Ohio universities. Intervention students watched a live-action (n = 755) or animated (n = 753) donation video. Control students (n = 753) viewed wellness information from the Centers for Disease Control and Prevention (CDC). The primary outcome was proportion of students who visited their state electronic donor registry to consent. The secondary outcome was intervention quality. Logistic regression assessed the effects of interventions on visiting the state registry to provide donation consent while controlling for baseline variables. RESULTS Students in the live-action video arm visited their state registry more frequently than students in the CDC arm (OR = 1.86, 95% CI = 1.20-2.88). There was no difference between students in the animated video and CDC arms (OR = 1.10, 95% CI = 0.69-1.76). The quality of the live-action video was rated lower than the animated video and the CDC text (75% ± 18, 84% ± 16, 80% ± 16, respectively; P < 0.001). CONCLUSION Students who watched the live-action video were more willing to visit their electronic donor registry to register as organ donors, but rated it lower in satisfaction. Future work should identify the most potent components of organ donation interventions.",2019,"There was no difference between students in the animated video and CDC arms (OR = 1.10, 95% CI = 0.69-1.76).","['2261 students at 3 northeastern Ohio universities', 'Control students (n\xa0=\xa0753']","['live-action (n\xa0=\xa0755) or animated (n\xa0=\xa0753) donation video', 'web-based video interventions', 'video interventions', 'viewed wellness information from the Centers for Disease Control and Prevention (CDC']","['quality of the live-action video', 'proportion of students who visited their state electronic donor registry to consent']","[{'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0028905', 'cui_str': 'Ohio'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0441472', 'cui_str': 'Action (qualifier value)'}, {'cui': 'C4517872', 'cui_str': 'Seven hundred and fifty-five'}, {'cui': 'C4049936', 'cui_str': 'Donation'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0449911', 'cui_str': 'View (attribute)'}, {'cui': 'C0007670', 'cui_str': 'CDC'}]","[{'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0441472', 'cui_str': 'Action (qualifier value)'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C4281784', 'cui_str': 'Electronics'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}]",2261.0,0.110195,"There was no difference between students in the animated video and CDC arms (OR = 1.10, 95% CI = 0.69-1.76).","[{'ForeName': 'J Daryl', 'Initials': 'JD', 'LastName': 'Thornton', 'Affiliation': 'Center for Reducing Health Disparities, MetroHealth Campus of Case Western Reserve University, Cleveland, Ohio.'}, {'ForeName': 'Bridget', 'Initials': 'B', 'LastName': 'Patrick', 'Affiliation': 'Department of Surgery, University Hospitals Cleveland Medical Center, Cleveland, Ohio.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Sullivan', 'Affiliation': 'Center for Reducing Health Disparities, MetroHealth Campus of Case Western Reserve University, Cleveland, Ohio.'}, {'ForeName': 'Jeffrey M', 'Initials': 'JM', 'LastName': 'Albert', 'Affiliation': 'Department of Population and Quantitative Health Sciences, Case Western Reserve University, Cleveland, Ohio.'}, {'ForeName': 'Kristine A', 'Initials': 'KA', 'LastName': 'Wong', 'Affiliation': 'Oakland, California.'}, {'ForeName': 'Margaret D', 'Initials': 'MD', 'LastName': 'Allen', 'Affiliation': 'Benaroya Research Institute, Seattle, Washington.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Kimble', 'Affiliation': 'Cleveland Minority Organ Tissue Transplant Education Program (MOTTEP), Cleveland, Ohio.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Mekesa', 'Affiliation': 'LifeBanc, Cleveland, Ohio.'}, {'ForeName': 'Gordon', 'Initials': 'G', 'LastName': 'Bowen', 'Affiliation': 'LifeBanc, Cleveland, Ohio.'}, {'ForeName': 'Ashwini R', 'Initials': 'AR', 'LastName': 'Sehgal', 'Affiliation': 'Center for Reducing Health Disparities, MetroHealth Campus of Case Western Reserve University, Cleveland, Ohio.'}]",Clinical transplantation,['10.1111/ctr.13506'] 466,30799154,Achieving self-management goals among low income older adults with functional limitations.,"Although self-management interventions can improve symptoms and disease among older adults, there is a dearth of literature on how self-management behaviors may improve factors related to the older adults' physical function. To fill this gap in the literature, we describe the patient-directed self-management goals in nursing visits that relate to physical function as part of a multi-component program. We analyze the self-management goals and outcomes of 367 low- income older adults with functional limitations who participated in the CAPABLE program: a program to reduce the health effects of impaired physical function in low-income older adults. We focus on the following self-management goals that participants chose with the nurses: pain management, depressive symptoms, incontinence, fall prevention, and communication with healthcare providers. The majority of participants chose pain (50%) or fall prevention (51%) as goals and partially or fully met their goals. Improvements across these areas may lead to improved physical function.",2019,The majority of participants chose pain (50%) or fall prevention (51%) as goals and partially or fully met their goals.,"['older adults', 'low-income older adults', 'low- income older adults with functional limitations who participated in the CAPABLE program', 'participants chose with the nurses: pain management, depressive symptoms, incontinence, fall prevention, and communication with healthcare providers', 'low income older adults with functional limitations', '367']",[],['physical function'],"[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0302604', 'cui_str': 'Low income'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0449295', 'cui_str': 'Limitation (attribute)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0002766', 'cui_str': 'Pain management (procedure)'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0021167', 'cui_str': 'Incontinence (finding)'}, {'cui': 'C0150223', 'cui_str': 'Fall prevention (procedure)'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0018724', 'cui_str': 'Healthcare Workers'}]",[],"[{'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}]",,0.0136326,The majority of participants chose pain (50%) or fall prevention (51%) as goals and partially or fully met their goals.,"[{'ForeName': 'Janiece L', 'Initials': 'JL', 'LastName': 'Taylor', 'Affiliation': 'Johns Hopkins School of Nursing, USA; Johns Hopkins School of Nursing Center of Innovative Care in Aging, USA. Electronic address: jwalke90@jhu.edu.'}, {'ForeName': 'Laken', 'Initials': 'L', 'LastName': 'Roberts', 'Affiliation': 'Johns Hopkins School of Nursing, USA.'}, {'ForeName': 'Melissa D', 'Initials': 'MD', 'LastName': 'Hladek', 'Affiliation': 'Johns Hopkins School of Nursing, USA.'}, {'ForeName': 'Minhui', 'Initials': 'M', 'LastName': 'Liu', 'Affiliation': 'Johns Hopkins School of Nursing, USA; Johns Hopkins School of Nursing Center of Innovative Care in Aging, USA.'}, {'ForeName': 'Manka', 'Initials': 'M', 'LastName': 'Nkimbeng', 'Affiliation': 'Johns Hopkins School of Nursing, USA.'}, {'ForeName': 'Cynthia M', 'Initials': 'CM', 'LastName': 'Boyd', 'Affiliation': 'Johns Hopkins School of Medicine, USA.'}, {'ForeName': 'Sarah L', 'Initials': 'SL', 'LastName': 'Szanton', 'Affiliation': 'Johns Hopkins School of Nursing, USA; Johns Hopkins School of Nursing Center of Innovative Care in Aging, USA.'}]","Geriatric nursing (New York, N.Y.)",['10.1016/j.gerinurse.2019.01.003'] 467,32078256,Long-term safety and efficacy of rIX-FP prophylaxis with extended dosing intervals up to 21 days in adults/adolescents with hemophilia B.,"BACKGROUND An international, multicenter extension study evaluated recombinant fusion protein linking recombinant coagulation factor IX (FIX) with recombinant human albumin (rIX-FP) in hemophilia B (FIX ≤ 2%) patients previously enrolled in a phase III study or who initiated rIX-FP prophylaxis following surgery. OBJECTIVES To investigate the long-term safety and efficacy of rIX-FP prophylaxis in adult previously treated patients (PTPs) with hemophilia B. METHODS Male PTPs were treated with a 7- (35-50 IU/kg), 10- or 14-day regimen (50-75 IU/kg). Patients ≥18 years who were well-controlled on a 14-day regimen for ≥6 months could switch to a 21-day regimen (100 IU/kg). RESULTS A total of 59 patients (aged 13-63 years) participated in the study. Following a single dose of 100 IU/kg rIX-FP, in patients eligible for the 21-day regimen, the mean terminal half-life was 143.2 hours. Mean steady-state FIX trough activity levels ranged from 22% with the 7-day regimen to 7.6% with the 21-day regimen. Median (Q1, Q3) annualized spontaneous bleeding rates were 0.00 (0.00, 1.67), 0.28 (0.00, 1.10), 0.37 (0.00, 1.68), and 0.00 (0.00, 0.45) for the 7-, 10-, 14-, and 21-day regimens, respectively. Comparable efficacy was demonstrated for both the 14- and 21-day regimens compared to the 7-day regimen. Overall, 96.5% of bleeding episodes were treated successfully with 1 to 2 rIX-FP infusions. No patients developed an inhibitor and treatment was well tolerated. CONCLUSIONS rIX-FP extended interval prophylaxis provides dosing flexibility and, in selected patients, a 21-day regimen may provide an alternative option to minimize treatment burden and individualize treatment.",2020,Comparable efficacy was demonstrated for both the 14- and 21-day regimens compared to the 7-day regimen.,"['adult previously treated patients (PTPs) with hemophilia B.\nMETHODS\n\n\nMale PTPs', 'hemophilia\xa0B (FIX ≤2%) patients previously enrolled in a phase III study or who initiated rIX-FP prophylaxis following surgery', '59 patients (aged 13-63 years) participated in the study', 'adults/adolescents with hemophilia', 'Patients ≥18 years who were well-controlled on a 14-day regimen for ≥6 months could switch to a 21-day regimen (100 IU/kg']","['recombinant fusion protein linking recombinant coagulation factor IX (FIX) with recombinant human albumin (rIX-FP', 'rIX-FP prophylaxis']","['Mean steady-state FIX trough activity levels', 'bleeding episodes', 'Median (Q1, Q3) annualized spontaneous bleeding rates', 'tolerated']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1321589', 'cui_str': 'Hemophilia - specialty'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0284927', 'cui_str': 'PTPS'}, {'cui': 'C0008533', 'cui_str': 'Christmas Disease'}, {'cui': 'C0443218', 'cui_str': 'Fixed (qualifier value)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0033107', 'cui_str': 'prophylaxis'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C3853142', 'cui_str': 'Well controlled'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0439463', 'cui_str': 'international unit/kilogram'}]","[{'cui': 'C0034857', 'cui_str': 'Recombinant Fusion Proteins'}, {'cui': 'C2826076', 'cui_str': 'nonacog alfa'}, {'cui': 'C0304925', 'cui_str': 'Albumin Human, USP'}, {'cui': 'C0033107', 'cui_str': 'prophylaxis'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0205361', 'cui_str': 'Steady (qualifier value)'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0443218', 'cui_str': 'Fixed (qualifier value)'}, {'cui': 'C0444506', 'cui_str': 'Trough (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous (qualifier value)'}]",59.0,0.0348372,Comparable efficacy was demonstrated for both the 14- and 21-day regimens compared to the 7-day regimen.,"[{'ForeName': 'Maria Elisa', 'Initials': 'ME', 'LastName': 'Mancuso', 'Affiliation': ""Angelo Bianchi Bonomi Hemophilia and Thrombosis Center, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, Milan, Italy.""}, {'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'Lubetsky', 'Affiliation': 'The Israeli National Haemophilia Center, Chaim Sheba Medical Center, Tel Hashomer, Israel.'}, {'ForeName': 'Brigitte', 'Initials': 'B', 'LastName': 'Pan-Petesch', 'Affiliation': 'Centre Hospitalier Régional Universitaire de Brest, Hôpital A. Morvan, Brest, France.'}, {'ForeName': 'Toshko', 'Initials': 'T', 'LastName': 'Lissitchkov', 'Affiliation': 'Department of Coagulation Disorders and Anemia, Specialized Hospital for Active Treatment Joan Pavel, Sofia, Bulgaria.'}, {'ForeName': 'Azusa', 'Initials': 'A', 'LastName': 'Nagao', 'Affiliation': 'Department of Blood Coagulation, Ogikubo Hospital, Tokyo, Japan.'}, {'ForeName': 'Wilfried', 'Initials': 'W', 'LastName': 'Seifert', 'Affiliation': 'CSL Behring, Marburg, Germany.'}, {'ForeName': 'Yanyan', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'CSL Behring, King of Prussia, PA, USA.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Santagostino', 'Affiliation': ""Angelo Bianchi Bonomi Hemophilia and Thrombosis Center, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, Milan, Italy.""}]",Journal of thrombosis and haemostasis : JTH,['10.1111/jth.14778'] 468,32228124,Effect of time restricted feeding on the gut microbiome in adults with obesity: A pilot study.,"BACKGROUND Time restricted feeding is a form of intermittent fasting where participants shorten the daily window in which they eat. AIM This is the first study to examine the effects of intermittent fasting on changes in the gut microbiome. METHODS Adults with obesity ( n = 14) participated in a daily 8-hour time restricted feeding intervention (8-hour feeding window/16-hour fasting window) for 12 weeks. Fecal microbiota were determined by 16 S rRNA (ribosomal ribonucleic acid) gene sequencing of stool samples. RESULTS Body weight decreased ( P < 0.05) by -2 ± 1 kg. Gut microbiota phylogenetic diversity remained unchanged. The two most common phyla were Firmicutes and Bacteroidetes accounting for 61.2% and 26.9% of total abundance at baseline. No significant alterations in the abundance of Firmicutes, Bacteroidetes, or any other phyla were detected after 12 weeks of time restricted feeding. CONCLUSIONS Time restricted feeding did not significantly alter the diversity or overall composition of the gut microbiome.",2020,"No significant alterations in the abundance of Firmicutes, Bacteroidetes, or any other phyla were detected after 12 weeks of time restricted feeding. ","['Adults with obesity ( n = 14) participated in a', 'adults with obesity']",['daily 8-hour time restricted feeding intervention'],"['Fecal microbiota', 'Gut microbiota phylogenetic diversity', 'Body weight', 'abundance of Firmicutes, Bacteroidetes, or any other phyla']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C1292429', 'cui_str': '8 hours (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0443288', 'cui_str': 'Restricted (qualifier value)'}, {'cui': 'C2987508', 'cui_str': 'Feeding (observable entity)'}]","[{'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C4018878', 'cui_str': 'Gastrointestinal Microbial Community'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C1254144', 'cui_str': 'Firmicutes'}, {'cui': 'C0995456', 'cui_str': 'Bacteroidetes'}]",,0.020168,"No significant alterations in the abundance of Firmicutes, Bacteroidetes, or any other phyla were detected after 12 weeks of time restricted feeding. ","[{'ForeName': 'Kelsey', 'Initials': 'K', 'LastName': 'Gabel', 'Affiliation': 'Department of Kinesiology and Nutrition, University of Illinois at Chicago, USA.'}, {'ForeName': 'Jarrad', 'Initials': 'J', 'LastName': 'Marcell', 'Affiliation': 'Department of Kinesiology and Nutrition, University of Illinois at Chicago, USA.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Cares', 'Affiliation': 'Department of Kinesiology and Nutrition, University of Illinois at Chicago, USA.'}, {'ForeName': 'Faiza', 'Initials': 'F', 'LastName': 'Kalam', 'Affiliation': 'Department of Kinesiology and Nutrition, University of Illinois at Chicago, USA.'}, {'ForeName': 'Sofia', 'Initials': 'S', 'LastName': 'Cienfuegos', 'Affiliation': 'Department of Kinesiology and Nutrition, University of Illinois at Chicago, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Ezpeleta', 'Affiliation': 'Department of Kinesiology and Nutrition, University of Illinois at Chicago, USA.'}, {'ForeName': 'Krista A', 'Initials': 'KA', 'LastName': 'Varady', 'Affiliation': 'Department of Kinesiology and Nutrition, University of Illinois at Chicago, USA.'}]",Nutrition and health,['10.1177/0260106020910907'] 469,32223724,"Effect of Zephyr Endobronchial Valves on Dyspnea, Activity Levels, and Quality of Life at One Year. Results from a Randomized Clinical Trial.","Rationale: Bronchoscopic lung volume reduction with Zephyr Valves improves lung function, exercise tolerance, and quality of life of patients with hyperinflated emphysema and little to no collateral ventilation. Objectives: Post hoc analysis of patient-reported outcomes (PROs), including multidimensional measures of dyspnea, activity, and quality of life, in the LIBERATE (Lung Function Improvement after Bronchoscopic Lung Volume Reduction with Pulmonx Endobronchial Valves used in Treatment of Emphysema) study are reported. Methods: A total of 190 patients with severe heterogeneous emphysema and little to no collateral ventilation in the target lobe were randomized 2:1 to the Zephyr Valve or standard of care. Changes in PROs at 12 months in the two groups were compared: dyspnea with the Transitional Dyspnea Index (TDI), focal score; the Chronic Obstructive Pulmonary Disease Assessment Test (CAT; breathlessness on hill/stairs); Borg; the EXAcerbations of Chronic pulmonary disease Tool-PRO, dyspnea domain; activity with the TDI, magnitude of task/effort/functional impairment, CAT (limited activities), and the St. George's Respiratory Questionnaire (SGRQ), activity domain; and psychosocial status with the SGRQ, impacts domain, and CAT (confidence and energy). Results: At 12 months, patients using the Zephyr Valve achieved statistically significant and clinically meaningful improvements in the SGRQ; CAT; and the TDI, focal score, compared with standard of care. Improvements in the SGRQ were driven by the impacts and activity domains ( P  < 0.05 and P  < 0.001, respectively). Reduction in CAT was through improvements in breathlessness ( P  < 0.05), energy level ( P  < 0.05), activities ( P  < 0.001), and increased confidence when leaving home ( P  < 0.05). The TDI measures of effort, task, and functional impairment were uniformly improved ( P  < 0.001). The EXAcerbations of Chronic Pulmonary Disease Tool (EXACT)-PRO, dyspnea domain, was significantly improved in the Zephyr Valve group. Improvements correlated with changes in residual volume and residual volume/TLC ratio. Conclusions: Patients with severe hyperinflated emphysema achieving lung volume reductions with Zephyr Valves experience improvements in multidimensional scores for breathlessness, activity, and psychosocial parameters out to at least 12 months.Clinical trial registered with www.clinicaltrials.gov (NCT01796392).",2020,"Reduction in CAT was through improvements in breathlessness (p<0.05), energy level (p<0.05), activities (p<0.001) and increased confidence when leaving home (p<0.05).","['patients with hyperinflated emphysema and little to no collateral ventilation (CV', '190 patients with severe heterogeneous emphysema and little to no CV in the target lobe', 'Severe hyperinflated emphysema patients']","['Zephyr Valve or Standard of Care (SoC', 'Zephyr Endobronchial Valves', 'Bronchoscopic Lung Volume Reduction (BLVR) with Zephyr® Valves']","['breathlessness (p<0.05), energy level (p<0.05), activities (p<0.001) and increased confidence', 'EXACT-PRO dyspnea domain', 'SGRQ, CAT, and TDI Focal score', 'TDI measures of effort, task, and functional impairment', 'Dyspnea: Transitional Dyspnea Index (TDI) focal score, COPD Assessment Test (CAT; breathlessness on hill/stairs), BORG, EXACT-PRO dyspnea domain; activity: TDI magnitude of task/effort/functional impairment, CAT (limited activities), SGRQ-activity domain; and psychosocial status', 'Dyspnea, Activity Levels and Quality of Life', 'multidimensional measures of dyspnea, activity, and QoL', ""St George's Respiratory Questionnaire (SGRQ) - impacts domain, CAT (confidence and energy"", 'residual volume (RV) and RV/TLC ratio.\nCONCLUSION', 'lung function, exercise tolerance and quality of life (QoL', 'multidimensional scores for breathlessness, activity and psychosocial parameters']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0013990', 'cui_str': 'Emphysema'}, {'cui': 'C0700321', 'cui_str': 'Small (qualifier value)'}, {'cui': 'C1275670', 'cui_str': 'Collateral'}, {'cui': 'C2945579', 'cui_str': 'Ventilation, function (observable entity)'}, {'cui': 'C4517622', 'cui_str': 'One hundred and ninety'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}]","[{'cui': 'C3888056', 'cui_str': 'Valve (physical object)'}, {'cui': 'C2936643', 'cui_str': 'Standard of Care'}, {'cui': 'C3880733', 'cui_str': 'Endobronchial valve'}, {'cui': 'C3697654', 'cui_str': 'BLVR - Bronchoscopic lung volume reduction'}]","[{'cui': 'C0013404', 'cui_str': 'Breathlessness'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0237529', 'cui_str': 'Self Confidence'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0524517', 'cui_str': 'Felis'}, {'cui': 'C0205234', 'cui_str': 'Focal (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C4284282', 'cui_str': 'COPD assessment test'}, {'cui': 'C0442532', 'cui_str': 'Hill (environment)'}, {'cui': 'C1704240', 'cui_str': 'Magnitudes (qualifier value)'}, {'cui': 'C0337459', 'cui_str': 'Psychosocial status (social concept)'}, {'cui': 'C0034380'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0035190', 'cui_str': 'Residual respiratory volume (observable entity)'}, {'cui': 'C0040509', 'cui_str': 'Total Lung Capacity'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0024119', 'cui_str': 'Lung Function Tests'}, {'cui': 'C0162521', 'cui_str': 'Exercise Tolerance'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",190.0,0.0340375,"Reduction in CAT was through improvements in breathlessness (p<0.05), energy level (p<0.05), activities (p<0.001) and increased confidence when leaving home (p<0.05).","[{'ForeName': 'Mark T', 'Initials': 'MT', 'LastName': 'Dransfield', 'Affiliation': 'Lung Health Center, University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': 'Justin L', 'Initials': 'JL', 'LastName': 'Garner', 'Affiliation': 'Royal Brompton Hospital and Imperial College, London, United Kingdom.'}, {'ForeName': 'Surya P', 'Initials': 'SP', 'LastName': 'Bhatt', 'Affiliation': 'Lung Health Center, University of Alabama at Birmingham, Birmingham, Alabama.'}, {'ForeName': 'Dirk-Jan', 'Initials': 'DJ', 'LastName': 'Slebos', 'Affiliation': 'Department of Pulmonary Diseases, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Klooster', 'Affiliation': 'Department of Pulmonary Diseases, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Frank C', 'Initials': 'FC', 'LastName': 'Sciurba', 'Affiliation': 'Division of Pulmonary, Allergy and Critical Care Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Pallav L', 'Initials': 'PL', 'LastName': 'Shah', 'Affiliation': 'Royal Brompton Hospital and Imperial College, London, United Kingdom.'}, {'ForeName': 'Nathaniel T', 'Initials': 'NT', 'LastName': 'Marchetti', 'Affiliation': 'Department of Thoracic Medicine and Surgery, Lewis Katz School of Medicine at Temple University, Philadelphia, Pennsylvania.'}, {'ForeName': 'Richard D', 'Initials': 'RD', 'LastName': 'Sue', 'Affiliation': ""St. Joseph's Hospital and Medical Center, Phoenix, Arizona.""}, {'ForeName': 'Shawn', 'Initials': 'S', 'LastName': 'Wright', 'Affiliation': ""St. Joseph's Hospital and Medical Center, Phoenix, Arizona.""}, {'ForeName': 'Hiram', 'Initials': 'H', 'LastName': 'Rivas-Perez', 'Affiliation': 'Department of Medicine, University of Louisville, Louisville, Kentucky.'}, {'ForeName': 'Tanya A', 'Initials': 'TA', 'LastName': 'Wiese', 'Affiliation': 'Norton Healthcare, Louisville, Kentucky.'}, {'ForeName': 'Momen M', 'Initials': 'MM', 'LastName': 'Wahidi', 'Affiliation': 'Duke University Medical Center, Duke University, Durham, North Carolina.'}, {'ForeName': 'Hugo', 'Initials': 'H', 'LastName': 'Goulart de Oliveira', 'Affiliation': 'Hospital de Clinicas de Porto Alegre, Porto Alegre, Brazil.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Armstrong', 'Affiliation': 'QST Consultations Ltd., Allendale, Michigan; and.'}, {'ForeName': 'Sri', 'Initials': 'S', 'LastName': 'Radhakrishnan', 'Affiliation': 'Pulmonx Corporation, Redwood City, California.'}, {'ForeName': 'Narinder S', 'Initials': 'NS', 'LastName': 'Shargill', 'Affiliation': 'Pulmonx Corporation, Redwood City, California.'}, {'ForeName': 'Gerard J', 'Initials': 'GJ', 'LastName': 'Criner', 'Affiliation': 'Department of Thoracic Medicine and Surgery, Lewis Katz School of Medicine at Temple University, Philadelphia, Pennsylvania.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Annals of the American Thoracic Society,['10.1513/AnnalsATS.201909-666OC'] 470,32223446,Peripheral Artery Disease and Venous Thromboembolic Events After Acute Coronary Syndrome: Role of Lipoprotein(a) and Modification by Alirocumab: Prespecified Analysis of the ODYSSEY OUTCOMES Randomized Clinical Trial.,"BACKGROUND Patients with acute coronary syndrome are at risk for peripheral artery disease (PAD) events and venous thromboembolism (VTE). PCSK9 (proprotein convertase subtilisin/kexin type 9) inhibitors reduce lipoprotein(a) and low-density lipoprotein cholesterol (LDL-C) levels. Our objective was to ascertain whether PCSK9 inhibition reduces the risk of PAD events or VTE after acute coronary syndrome, and if such effects are related to levels of lipoprotein(a) or LDL-C. METHODS This was a prespecified analysis of the ODYSSEY OUTCOMES randomized clinical trial (Evaluation of Cardiovascular Outcomes After an Acute Coronary Syndrome), which was conducted in 18 924 patients with recent acute coronary syndrome on intensive or maximum-tolerated statin treatment who were randomized to the PCSK9 inhibitor alirocumab or placebo. In a prespecified analysis, PAD events (critical limb ischemia, limb revascularization, or amputation for ischemia) and VTE (deep vein thrombosis or pulmonary embolism) were assessed. LDL-C was corrected (LDL-C corrected ) for cholesterol content in lipoprotein(a). RESULTS At baseline, median lipoprotein(a) and LDL-C corrected were 21 and 75 mg/dL, respectively; with alirocumab, median relative reductions were 23.5% and 70.6%, respectively. PAD events and VTE occurred in 246 and 92 patients, respectively. In the placebo group, risk of PAD events was related to baseline quartile of lipoprotein(a) ( P trend =0.0021), and tended to associate with baseline quartile of LDL-C corrected ( P trend =0.06); VTE tended to associate with baseline quartile of lipoprotein(a) ( P trend =0.06), but not LDL-C corrected ( P trend =0.85). Alirocumab reduced risk of PAD events (hazard ratio [HR], 0.69 [95% CI, 0.54-0.89]; P =0.004), with nonsignificantly fewer VTE events (HR, 0.67 [95% CI, 0.44-1.01]; P =0.06). Reduction in PAD events with alirocumab was associated with baseline quartile of lipoprotein(a) ( P trend =0.03), but not LDL-C corrected ( P trend =0.50). With alirocumab, the change from baseline to Month 4 in lipoprotein(a), but not LDL-C corrected , was associated with the risk of VTE and the composite of VTE and PAD events. CONCLUSIONS In statin-treated patients with recent acute coronary syndrome, risk of PAD events is related to lipoprotein(a) level and is reduced by alirocumab, particularly among those with high lipoprotein(a). Further study is required to confirm whether risk of VTE is related to lipoprotein(a) level and its reduction with alirocumab. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT01663402.",2020,"Alirocumab reduced risk of PAD events (hazard ratio [HR], 0.69; 95% confidence interval [CI], 0.54-0.89; P =0.004), with non-significantly fewer VTE events (HR, 0.67; 95% CI, 0.44-1.01; P =0.06).","['Patients with acute coronary syndrome (ACS', '18 924 patients with recent ACS on intensive or maximum-tolerated statin treatment who were randomized to the']","['Alirocumab', 'PCSK9 inhibitor alirocumab or placebo', 'placebo', 'PCSK9 inhibition']","['PAD events', 'lipoprotein(a) and low-density lipoprotein cholesterol (LDL-C) levels', 'PAD events and VTE', 'risk of VTE and the composite of VTE and PAD events', 'peripheral artery disease (PAD) events and venous thromboembolism (VTE', 'VTE events', 'median lipoprotein(a) and LDL-C corrected', 'Peripheral Artery Disease and Venous Thromboembolic Events', 'PAD events (critical limb ischemia, limb revascularization, or amputation for ischemia) and VTE (deep vein thrombosis or pulmonary embolism', 'risk of PAD events']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0948089', 'cui_str': 'Acute Coronary Syndrome'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C0360714', 'cui_str': 'Statins'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C3491162', 'cui_str': 'alirocumab'}, {'cui': 'C4522007', 'cui_str': 'Proprotein convertase subtilisin/kexin type 9 inhibitor'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}]","[{'cui': 'C0441601', 'cui_str': 'Padding (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0023820', 'cui_str': 'Circulating Lipoproteins'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0630906', 'cui_str': 'triethoxyvinylsilane'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C1704436', 'cui_str': 'Peripheral Artery Disease'}, {'cui': 'C1861172', 'cui_str': 'Venous Thromboembolism'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}, {'cui': 'C0348013', 'cui_str': 'Venous (qualifier value)'}, {'cui': 'C0040038', 'cui_str': 'Thromboembolism'}, {'cui': 'C1142264', 'cui_str': 'Critical limb ischemia'}, {'cui': 'C0472662', 'cui_str': 'Limb revascularization (procedure)'}, {'cui': 'C0002688', 'cui_str': 'Amputation'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C0149871', 'cui_str': 'Deep Vein Thrombosis'}, {'cui': 'C0034065', 'cui_str': 'Pulmonary Embolism'}]",18924.0,0.568608,"Alirocumab reduced risk of PAD events (hazard ratio [HR], 0.69; 95% confidence interval [CI], 0.54-0.89; P =0.004), with non-significantly fewer VTE events (HR, 0.67; 95% CI, 0.44-1.01; P =0.06).","[{'ForeName': 'Gregory G', 'Initials': 'GG', 'LastName': 'Schwartz', 'Affiliation': 'Division of Cardiology, University of Colorado School of Medicine, Aurora (G.G.S.).'}, {'ForeName': 'Philippe Gabriel', 'Initials': 'PG', 'LastName': 'Steg', 'Affiliation': 'Université de Paris, Assistance Publique-Hôpitaux de Paris, Hôpital Bichat, France (P.G.S.).'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Szarek', 'Affiliation': 'State University of New York, Downstate School of Public Health, Brooklyn (M.S.).'}, {'ForeName': 'Vera A', 'Initials': 'VA', 'LastName': 'Bittner', 'Affiliation': 'University of Alabama at Birmingham (V.A.B.).'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Diaz', 'Affiliation': 'Estudios Cardiológicos Latinoamérica, Instituto Cardiovascular de Rosario, Argentina (R.D.).'}, {'ForeName': 'Shaun G', 'Initials': 'SG', 'LastName': 'Goodman', 'Affiliation': 'Canadian VIGOUR Centre, University of Alberta, Edmonton, Canada (S.G.G.).'}, {'ForeName': 'Yong-Un', 'Initials': 'YU', 'LastName': 'Kim', 'Affiliation': 'Sanofi, Paris, France (Y.-U.K.).'}, {'ForeName': 'J Wouter', 'Initials': 'JW', 'LastName': 'Jukema', 'Affiliation': 'Leiden University Medical Center, The Netherlands (J.W.J.).'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Pordy', 'Affiliation': 'Regeneron Pharmaceuticals, Tarrytown, NY (R.P.).'}, {'ForeName': 'Matthew T', 'Initials': 'MT', 'LastName': 'Roe', 'Affiliation': 'Duke Clinical Research Institute, Duke University Medical Center, Durham, NC (M.T.R.).'}, {'ForeName': 'Harvey D', 'Initials': 'HD', 'LastName': 'White', 'Affiliation': 'Green Lane Cardiovascular Services Auckland City Hospital, New Zealand (H.D.W.).'}, {'ForeName': 'Deepak L', 'Initials': 'DL', 'LastName': 'Bhatt', 'Affiliation': ""Brigham and Women's Hospital Heart & Vascular Center and Harvard Medical School, Boston, MA (D.L.B.).""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Circulation,['10.1161/CIRCULATIONAHA.120.046524'] 471,31085097,Acceptability and Feasibility of a Mindfulness-Based Intervention for Pain Catastrophizing among Persons with Sickle Cell Disease.,"BACKGROUND Few investigators have developed and tested nonpharmacological interventions for helping persons with sickle cell disease (SCD) manage persistent pain. AIMS The purpose of this pilot study was to examine the feasibility and acceptability of a mindfulness-based intervention (MBI) in adults with SCD and chronic pain and to gather preliminary data on its efficacy. DESIGN Data on feasibility and acceptability, including recruitment, retention, and attendance rates, were collected during a single-site, randomized control trial. Participants were randomly assigned to either a 6-session group telephonic MBI or a wait-listed control. Pain catastrophizing was assessed at baseline and at weeks 1, 3, and 6. SETTING Outpatient, comprehensive, interdisciplinary sickle cell disease center in the Southeast. PARTICIPANTS/SUBJECTS Adults at least 18 years of age with a self-reported diagnosis of sickle cell disease who self-identified as having chronic, non-cancer pain that persisted on most days for at least 6 months and adversely affected function and/or well-being. METHODS Seventy-eight adults were recruited; 18 (23%) declined to participate; 60 were randomly assigned to either the MBI (N = 40) or control (N = 20). Of those, 14 (35%) from the MBI and 12 (60%) from the control group withdrew immediately after random allocation, resulting in 34 evaluable cases (MBI: N = 26; control: N = 8). RESULTS Among the 26 assigned to MBI, the median number of sessions attended per person was 4; 7 (27%) attended all six sessions. Qualitative findings indicated that MBI participants viewed the program as acceptable and liked the telephonic format, community, and content. Reductions in pain catastrophizing outcomes were identified after intervention. CONCLUSIONS An MBI is feasible and acceptable for persons with SCD experiencing chronic pain. A larger randomized controlled trial to establish MBI efficacy on pain and related outcomes for SCD will provide nonpharmacologic, behavioral pain management options for nurses and other clinicians caring for persons with SCD and chronic pain.",2019,"Qualitative findings indicated that MBI participants viewed the program as acceptable and liked the telephonic format, community, and content.","['persons with SCD experiencing chronic pain', 'Persons with Sickle Cell Disease', 'Seventy-eight adults were recruited; 18 (23%) declined to participate; 60', 'Outpatient, comprehensive, interdisciplinary sickle cell disease center in the Southeast', 'adults with SCD and chronic pain', 'Adults at least 18 years of age with a self-reported diagnosis of sickle cell disease who self-identified as having chronic, non-cancer pain that persisted on most days for at least 6 months and adversely affected function and/or well-being', 'persons with sickle cell disease (SCD) manage persistent pain', 'persons with SCD and chronic pain']","['mindfulness-based intervention (MBI', 'MBI', '6-session group telephonic MBI or a wait-listed control', 'Mindfulness-Based Intervention']","['Pain catastrophizing', 'feasibility and acceptability', 'feasibility and acceptability, including recruitment, retention, and attendance rates', 'Acceptability and Feasibility', 'pain catastrophizing outcomes']","[{'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0964695', 'cui_str': 's(7)(beta)CD'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain (finding)'}, {'cui': 'C0002895', 'cui_str': 'Sickle Cell Disease'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0596240', 'cui_str': 'Tumor-Related Pain'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]","[{'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C0035280', 'cui_str': 'Retention'}]",78.0,0.0852438,"Qualitative findings indicated that MBI participants viewed the program as acceptable and liked the telephonic format, community, and content.","[{'ForeName': 'Leigh Ann', 'Initials': 'LA', 'LastName': 'Simmons', 'Affiliation': 'Duke University School of Nursing, Durham, North Carolina. Electronic address: leighann.simmons@duke.edu.'}, {'ForeName': 'Hants', 'Initials': 'H', 'LastName': 'Williams', 'Affiliation': 'BioVirtua, San Francisco, California.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Silva', 'Affiliation': 'Duke University School of Nursing, Durham, North Carolina; Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, North Carolina.'}, {'ForeName': 'Francis', 'Initials': 'F', 'LastName': 'Keefe', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, North Carolina.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Tanabe', 'Affiliation': 'Duke University School of Nursing, Durham, North Carolina.'}]",Pain management nursing : official journal of the American Society of Pain Management Nurses,['10.1016/j.pmn.2018.10.002'] 472,31540617,Integrated stepped alcohol treatment for patients with HIV and liver disease: A randomized trial.,"BACKGROUND There is no known safe level of alcohol use among patients with HIV and liver disease. We examined the effectiveness of integrated stepped alcohol treatment (ISAT) on alcohol use, HIV, and liver outcomes among patients with HIV and liver disease. METHODS In this multi-site, randomized trial conducted between January 28, 2013 through July 15, 2016, we enrolled 95 patients with HIV and liver disease [defined as having active hepatitis C infection or FIB-4 score > 1.45]. ISAT (n = 49) involved: Step 1- Brief Negotiated Interview with telephone booster, Step 2- Motivational Enhancement Therapy, and Step 3- Addiction Physician Management. Treatment as usual (TAU) (n = 46) involved receipt of a health handout plus routine care. Analyses were conducted based on intention to treat. RESULTS Among ISAT participants, 55% advanced to Step 2, among whom 70% advanced to Step 3. Participants randomized to ISAT and TAU increased abstinence (primary outcome) over time. Abstinence rates were non-significantly higher by self-report (38% vs. 23%, adjusted odds ratio [AOR] [95% CI] = 2.6 [0.8, 9.0]) and phosphatidylethanol (43% vs. 32%, AOR [95% CI] = 1.8 [0.5, 6.3] among those randomized to ISAT vs. TAU at week 24. VACS Index scores (AMD [95% CI] = 1.1 [-3.2, 5.5]) and the proportion with an undetectable HIV viral load (AOR [95% CI] = 0.3 [0.1, 1.3]) did not differ by group at week 24 (p values >0.05). ISAT had non-significantly lower FIB-4 scores (adjusted mean difference [AMD] [95% CI] = -0.2 [-0.9, 0.5]), ALT (AMD [95% CI] = -7 [-20, 7]) and AST (AMD [95% CI] = -4 [-15, 7]) at week 24 compared to TAU. CONCLUSION ISAT is feasible and potentially effective at enhancing delivery of evidence-based alcohol treatment to promote alcohol abstinence and improve liver biomarkers among patients with HIV and liver disease.",2019,"Abstinence rates were non-significantly higher by self-report (38% vs. 23%, adjusted odds ratio [AOR] [95% CI] = 2.6 [0.8, 9.0]) and phosphatidylethanol (43% vs. 32%, AOR [95% CI] = 1.8 [0.5, 6.3] among those randomized to ISAT vs. TAU at week 24.","['patients with HIV and liver disease', 'January 28, 2013 through July 15, 2016, we enrolled 95 patients with HIV and liver disease [defined as having active hepatitis C infection or FIB-4 score\u202f>\u202f1.45']","['ISAT', 'Integrated stepped alcohol treatment', 'health handout plus routine care', 'integrated stepped alcohol treatment (ISAT', 'ISAT and TAU']","['liver biomarkers', 'Abstinence rates', 'proportion with an undetectable HIV viral load', 'alcohol use, HIV, and liver outcomes', 'VACS Index scores', 'FIB-4 scores']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0023895', 'cui_str': 'Disorder of liver (disorder)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0019196', 'cui_str': 'Parenterally-Transmitted Non-A, Non-B Hepatitis'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C4517505', 'cui_str': '1.45'}]","[{'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C1720655', 'cui_str': 'Tau'}]","[{'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C1168369', 'cui_str': 'HIV viral load'}, {'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",95.0,0.155409,"Abstinence rates were non-significantly higher by self-report (38% vs. 23%, adjusted odds ratio [AOR] [95% CI] = 2.6 [0.8, 9.0]) and phosphatidylethanol (43% vs. 32%, AOR [95% CI] = 1.8 [0.5, 6.3] among those randomized to ISAT vs. TAU at week 24.","[{'ForeName': 'E Jennifer', 'Initials': 'EJ', 'LastName': 'Edelman', 'Affiliation': 'Yale School of Medicine, New Haven, CT 06510, United States of America; Center for Interdisciplinary Research on AIDS, Yale School of Public Health, New Haven, CT 06510, United States of America. Electronic address: ejennifer.edelman@yale.edu.'}, {'ForeName': 'Stephen A', 'Initials': 'SA', 'LastName': 'Maisto', 'Affiliation': 'Syracuse University, Syracuse, NY 13244, United States of America.'}, {'ForeName': 'Nathan B', 'Initials': 'NB', 'LastName': 'Hansen', 'Affiliation': 'Center for Interdisciplinary Research on AIDS, Yale School of Public Health, New Haven, CT 06510, United States of America; College of Public Health, University of Georgia, Athens, GA 30602, United States of America.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Cutter', 'Affiliation': 'Yale School of Medicine, New Haven, CT 06510, United States of America.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Dziura', 'Affiliation': 'Yale Center for Analytic Sciences, Yale School of Public Health, New Haven, CT 06511, United States of America.'}, {'ForeName': 'Yanhong', 'Initials': 'Y', 'LastName': 'Deng', 'Affiliation': 'Yale Center for Analytic Sciences, Yale School of Public Health, New Haven, CT 06511, United States of America.'}, {'ForeName': 'Lynn E', 'Initials': 'LE', 'LastName': 'Fiellin', 'Affiliation': 'Yale School of Medicine, New Haven, CT 06510, United States of America; Center for Interdisciplinary Research on AIDS, Yale School of Public Health, New Haven, CT 06510, United States of America.'}, {'ForeName': 'Patrick G', 'Initials': 'PG', 'LastName': ""O'Connor"", 'Affiliation': 'Yale School of Medicine, New Haven, CT 06510, United States of America.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Bedimo', 'Affiliation': 'Veterans Affairs North Texas Health Care System, UT Southwestern, Dallas, TX 75216, United States of America.'}, {'ForeName': 'Cynthia L', 'Initials': 'CL', 'LastName': 'Gibert', 'Affiliation': 'D.C. VAMC, George Washington University School of Medicine and Health Sciences, Washington, DC 20422, United States of America.'}, {'ForeName': 'Vincent C', 'Initials': 'VC', 'LastName': 'Marconi', 'Affiliation': 'Atlanta VAMC, Emory University School of Medicine, Atlanta, GA 30033, United States of America.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Rimland', 'Affiliation': 'Atlanta VAMC, Emory University School of Medicine, Atlanta, GA 30033, United States of America.'}, {'ForeName': 'Maria C', 'Initials': 'MC', 'LastName': 'Rodriguez-Barradas', 'Affiliation': 'Michael E. DeBakey VAMC, Baylor College of Medicine, Houston, TX 77030, United States of America.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Simberkoff', 'Affiliation': 'VA NY Harbor Healthcare System, New York University School of Medicine, New York, NY 10010, United States of America.'}, {'ForeName': 'Janet P', 'Initials': 'JP', 'LastName': 'Tate', 'Affiliation': 'Yale School of Medicine, New Haven, CT 06510, United States of America.'}, {'ForeName': 'Amy C', 'Initials': 'AC', 'LastName': 'Justice', 'Affiliation': 'Yale School of Medicine, New Haven, CT 06510, United States of America; VA Connecticut Healthcare System, Veterans Aging Cohort Study, West Haven, CT 06516, United States of America.'}, {'ForeName': 'Kendall J', 'Initials': 'KJ', 'LastName': 'Bryant', 'Affiliation': 'National Institute on Alcohol Abuse and Alcoholism HIV/AIDS Program, Bethesda, MD 20892-7003, United States of America.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Fiellin', 'Affiliation': 'Yale School of Medicine, New Haven, CT 06510, United States of America; Center for Interdisciplinary Research on AIDS, Yale School of Public Health, New Haven, CT 06510, United States of America.'}]",Journal of substance abuse treatment,['10.1016/j.jsat.2019.08.007'] 473,31278458,Short-term outcomes of radical excision vs. phenolisation of the sinus tract in primary sacrococcygeal pilonidal sinus disease: a randomized-controlled trial.,"BACKGROUND Phenolisation of Sacrococcygeal pilonidal sinus disease (SPSD) seems to have advantages over radical excision; however, a randomized-controlled trial (RCT) comparing both techniques is lacking. The aim of our study was to compare sinus pit excision and phenolisation of the sinus tract with radical excision in SPSD in terms of return to normal daily activities. METHODS This study was a single-center RCT. Fifty patients who presented with primary SPSD were randomized to phenolisation and 50 patients to excision. The primary endpoint was time to return to normal daily activities. Secondary endpoints were quality of life, complaints related to SPSD, surgical site infection, and wound epithelialization. Patients were treated in a 1-day surgery setting. Complaints related to SPSD were evaluated and symptoms were scored by the participants on a 6-point scale before surgery, and patients kept a diary for 2 weeks on complaints related to the surgical treatment (the same scoring system as preoperatively) and pain, evaluated with a VAS. Quality of life (QoL) was measured preoperatively with a VAS and the Short Form-36 Health Survey (SF-36). At 2, 6, and 12 weeks after surgery, patients were evaluated using a questionnaire containing the following items: patients' satisfaction (disease, compared with preoperatively, scored as cured, improved, unchanged or worsened), five complaints related to the surgical treatment (the same scoring system as preoperatively and in the diary), QoL (VAS and SF-36), and return to normal daily activities. The wound was assessed 2, 6, and 12 weeks postoperatively by one of the investigators (EF or NS), using an assessment form RESULTS: The mean time to return to normal daily activities was significantly shorter after phenolisation (5.2 ± SD 6.6 days vs. 14.5 ± 25.0 days, p = 0.023). 2 weeks after surgery, all patients in the phenolisation group and 85.4% of patients in the excision group returned to normal daily activities (p = 0.026). Pain was significantly lower after phenolisation at 2 weeks postoperatively (0.8 ± 1.0 vs. 1.6 ± 1.3, p = 0.003). Surgical site infection occurred significantly more often after radical excision (n = 10, 21.7% vs. n = 2, 4.0%, p = 0.020). At 6 and 12 weeks, complete wound epithelialization was more frequently achieved after phenolisation (69.0% vs. 37.0%, p = 0.003 and 81.0% vs. 60.9%, p = 0.039, respectively). CONCLUSIONS Pit excision with phenolisation of SPSD resulted in a quicker return to normal daily activities, less pain, and quicker wound epithelialization compared to radical excision. Surgeons should consider phenolisation in patients with primary SPSD.",2019,"2 weeks after surgery, all patients in the phenolisation group and 85.4% of patients in the excision group returned to normal daily activities (p = 0.026).","['Fifty patients who presented with primary SPSD', 'patients with primary SPSD', 'primary sacrococcygeal pilonidal sinus disease']","['radical excision vs. phenolisation of the sinus tract', 'radical excision']","['mean time to return to normal daily activities', 'quicker return to normal daily activities, less pain, and quicker wound epithelialization', 'normal daily activities', 'quality of life, complaints related to SPSD, surgical site infection, and wound epithelialization', 'Pain', 'complete wound epithelialization', 'time to return to normal daily activities', 'Quality of life (QoL', 'Surgical site infection']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0031925', 'cui_str': 'Pilonidal Cyst'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0184918', 'cui_str': 'Radical excision (procedure)'}, {'cui': 'C0016169', 'cui_str': 'Fistula'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0332156', 'cui_str': 'Return to (contextual qualifier) (qualifier value)'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C3266038', 'cui_str': 'Wound Epithelialization'}, {'cui': 'C0034380'}, {'cui': 'C0277786', 'cui_str': 'Presenting complaint'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0038941', 'cui_str': 'Postoperative Wound Infection'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]",50.0,0.0463757,"2 weeks after surgery, all patients in the phenolisation group and 85.4% of patients in the excision group returned to normal daily activities (p = 0.026).","[{'ForeName': 'A A', 'Initials': 'AA', 'LastName': 'Pronk', 'Affiliation': 'Department of Surgery, Diakonessenhuis, Bosboomstraat 1, P.O. Box 80250, 3508 TG, Utrecht, The Netherlands. apronk1@diakhuis.nl.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Smakman', 'Affiliation': 'Department of Surgery, Diakonessenhuis, Bosboomstraat 1, P.O. Box 80250, 3508 TG, Utrecht, The Netherlands.'}, {'ForeName': 'E J B', 'Initials': 'EJB', 'LastName': 'Furnee', 'Affiliation': 'Department of Abdominal Surgery, University Medical Center Groningen, Groningen, The Netherlands.'}]",Techniques in coloproctology,['10.1007/s10151-019-02030-w'] 474,30661240,Demonstrating Heterogeneity of Treatment Effects Among Patients: An Overlooked but Important Step Toward Precision Medicine.,"Although heterogeneity in the observed outcomes in clinical trials is often assumed to reflect a true heterogeneous response, it could actually be due to random variability. This retrospective analysis of four randomized, double-blind, placebo-controlled multiperiod (i.e., episode) crossover trials of fentanyl for breakthrough cancer pain illustrates the use of multiperiod crossover trials to examine heterogeneity of treatment response. A mixed-effects model, including fixed effects for treatment and episode and random effects for patient and treatment-by-patient interaction, was used to assess the heterogeneity in patients' responses to treatment during each episode. A significant treatment-by-patient interaction was found for three of four trials (P < 0.05), suggesting heterogeneity of the effect of fentanyl among different patients in each trial. Similar analyses in other therapeutic areas could identify conditions and therapies that should be investigated further for predictors of treatment response in efforts to maximize the efficiency of developing precision medicine strategies.",2019,"A significant treatment-by-patient interaction was found for three of four trials (P < 0.05), suggesting heterogeneity of the effect of fentanyl among different patients in each trial.",['Patients'],"['placebo-controlled multiperiod', 'fentanyl']",[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}]",[],4.0,0.168579,"A significant treatment-by-patient interaction was found for three of four trials (P < 0.05), suggesting heterogeneity of the effect of fentanyl among different patients in each trial.","[{'ForeName': 'Jennifer S', 'Initials': 'JS', 'LastName': 'Gewandter', 'Affiliation': 'Department of Anesthesiology and Perioperative Medicine, University of Rochester, Rochester, New York, USA.'}, {'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'McDermott', 'Affiliation': 'Department of Biostatistics and Computational Biology, University of Rochester, Rochester, New York, USA.'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'He', 'Affiliation': 'Department of Epidemiology, Tulane University, New Orleans, Louisiana, USA.'}, {'ForeName': 'Shan', 'Initials': 'S', 'LastName': 'Gao', 'Affiliation': 'Department of Biostatistics and Computational Biology, University of Rochester, Rochester, New York, USA.'}, {'ForeName': 'Xueya', 'Initials': 'X', 'LastName': 'Cai', 'Affiliation': 'Department of Biostatistics and Computational Biology, University of Rochester, Rochester, New York, USA.'}, {'ForeName': 'John T', 'Initials': 'JT', 'LastName': 'Farrar', 'Affiliation': 'Department of Biostatistics and Epidemiology, University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Nathaniel P', 'Initials': 'NP', 'LastName': 'Katz', 'Affiliation': 'Analgesic Solutions, Natick, Massachusetts, USA.'}, {'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Markman', 'Affiliation': 'Department of Neurosurgery, University of Rochester, Rochester, New York, USA.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Senn', 'Affiliation': 'Luxembourg Institute of Health, Strassen, Luxembourg.'}, {'ForeName': 'Dennis C', 'Initials': 'DC', 'LastName': 'Turk', 'Affiliation': 'Department of Anesthesiology & Pain Medicine, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Robert H', 'Initials': 'RH', 'LastName': 'Dworkin', 'Affiliation': 'Department of Anesthesiology and Perioperative Medicine, University of Rochester, Rochester, New York, USA.'}]",Clinical pharmacology and therapeutics,['10.1002/cpt.1372'] 475,32228288,Does Diabetes Distress Influence Clinical Response to an mHealth Diabetes Self-Management Education and Support Intervention?,"PURPOSE The purpose of this study was to examine whether baseline levels of diabetes distress (DD) impacted clinical benefit from a mobile health (mHealth) diabetes self-management education and support (DSME/S) intervention (""Dulce Digital""). METHODS This secondary analysis included the full sample of 126 Hispanic adults (mean age = 48.43 years, SD = 9.80) with type 2 diabetes and glycosylated hemoglobin A1C >7.5% enrolled from a Federally Qualified Health Center in a randomized, nonblinded clinical trial that compared Dulce Digital to usual care. Dulce Digital participants received educational/motivational, medication reminders, and blood glucose monitoring prompt text messages over 6 months. RESULTS Baseline levels of DD prospectively moderated the effect of Dulce Digital (vs usual care) on glycemic control over 6 months, such that Dulce Digital participants with higher DD experienced relatively greater benefit from the intervention. The effect of the intervention on A1C change was 178% larger among individuals experiencing moderate/high versus no/low DD. CONCLUSIONS Although research has found DD to be associated with poorer self-management and clinical outcomes, individuals already distressed about their diabetes may benefit from a lower-burden mHealth DSME/S approach.",2020,"Dulce Digital participants received educational/motivational, medication reminders, and blood glucose monitoring prompt text messages over 6 months. ","['126 Hispanic adults (mean age = 48.43 years, SD = 9.80) with type 2 diabetes and glycosylated hemoglobin A1C >7.5% enrolled from a Federally Qualified Health Center', 'individuals experiencing moderate/high versus no/low DD']","['Dulce Digital to usual care', 'educational/motivational, medication reminders, and blood glucose monitoring prompt text messages over 6 months', 'mobile health (mHealth) diabetes self-management education and support (DSME/S) intervention (""Dulce Digital']",['A1C change'],"[{'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C4505389', 'cui_str': 'Glycosylated Hemoglobin A1c'}, {'cui': 'C4517859', 'cui_str': 'Seven point five'}, {'cui': 'C0475309', 'cui_str': 'Health center (environment)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}]","[{'cui': 'C0442015', 'cui_str': 'Digital X-ray (qualifier value)'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C0181904', 'cui_str': 'Monitor, device (physical object)'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0086969', 'cui_str': 'Self-Management'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}]","[{'cui': 'C4521595', 'cui_str': 'Lcpl'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]",126.0,0.0383404,"Dulce Digital participants received educational/motivational, medication reminders, and blood glucose monitoring prompt text messages over 6 months. ","[{'ForeName': 'Taylor L', 'Initials': 'TL', 'LastName': 'Clark', 'Affiliation': 'San Diego Joint Doctoral Program in Clinical Psychology, San Diego State University/University of California, San Diego, California.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Gallo', 'Affiliation': 'Department of Psychology, San Diego State University, San Diego, California.'}, {'ForeName': 'Johanna A', 'Initials': 'JA', 'LastName': 'Euyoque', 'Affiliation': 'Scripps Whittier Diabetes Institute, Scripps Health, San Diego, California.'}, {'ForeName': 'Athena', 'Initials': 'A', 'LastName': 'Philis-Tsimikas', 'Affiliation': 'Scripps Whittier Diabetes Institute, Scripps Health, San Diego, California.'}, {'ForeName': 'Addie', 'Initials': 'A', 'LastName': 'Fortmann', 'Affiliation': 'Scripps Whittier Diabetes Institute, Scripps Health, San Diego, California.'}]",The Diabetes educator,['10.1177/0145721720913276'] 476,31495379,Prevention of Alcohol and Other Drug Overuse Among Nightclub Patrons: A Randomized Trial of a Group-Based Mobile Intervention at Nightclubs.,"OBJECTIVE Electronic music dance events (EMDEs) at nightclubs attract young adults engaging in high-risk alcohol and other drug (AOD) use. Studies show that most patrons arrive at clubs in groups and that these peer groups influence drinking. Therefore, peer groups are a natural context for preventing risk behaviors. This article examined outcomes of a randomized controlled trial of a group-based mobile intervention at nightclubs, Nightlife Safety Plans (NSP). METHOD The sample comprised 352 groups, consisting of 959 participants (45.3% female) at 41 events across seven nightclubs hosting EMDEs. Club patrons were surveyed anonymously and completed breath tests as they entered and exited clubs. Oral fluid samples collected from patrons at exit assessed drug use. Analyses examining assignment to NSP versus a control condition on fire safety predicted individual- and group-level protective strategy use and AOD use, controlling for background variables. RESULTS At the individual level, participation in NSP was related to increased protective actions to keep group members safe. No effects were found on actions to keep oneself safe or in response to overuse. At the group level, assignment to NSP was related to a higher average number of group safety strategies. Participation in NSP was associated with lower blood alcohol concentration but unrelated to tetrahydrocannabinol and cocaine. CONCLUSIONS NSP appears to be efficacious for increased protective actions to keep group members safe from overuse and for reduced blood alcohol concentration among EMDE patrons. The findings support the use of an intervention utilizing group-based strategies presented proximal to risk settings.",2019,"CONCLUSIONS NSP appears to be efficacious for increased protective actions to keep group members safe from overuse and for reduced blood alcohol concentration among EMDE patrons.","['The sample comprised 352 groups, consisting of 959 participants (45.3% female) at 41 events across seven nightclubs hosting EMDEs', 'nightclubs attract young adults engaging in high-risk alcohol and other drug (AOD) use', 'Nightclub Patrons']","['Group-Based Mobile Intervention', 'group-based mobile intervention at nightclubs, Nightlife Safety Plans (NSP']",['blood alcohol concentration'],"[{'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0442567', 'cui_str': 'Nightclub (environment)'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married (finding)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0449889', 'cui_str': 'Drug used (attribute)'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0442567', 'cui_str': 'Nightclub (environment)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1301732', 'cui_str': 'Planned'}]","[{'cui': 'C0684262', 'cui_str': 'Blood Alcohol Level'}]",959.0,0.0245119,"CONCLUSIONS NSP appears to be efficacious for increased protective actions to keep group members safe from overuse and for reduced blood alcohol concentration among EMDE patrons.","[{'ForeName': 'Hilary F', 'Initials': 'HF', 'LastName': 'Byrnes', 'Affiliation': 'Prevention Research Center, Pacific Institute for Research and Evaluation, Berkeley, California.'}, {'ForeName': 'Brenda A', 'Initials': 'BA', 'LastName': 'Miller', 'Affiliation': 'Prevention Research Center, Pacific Institute for Research and Evaluation, Berkeley, California.'}, {'ForeName': 'Beth', 'Initials': 'B', 'LastName': 'Bourdeau', 'Affiliation': 'Division of Prevention Science, University of California San Francisco, San Francisco, California.'}, {'ForeName': 'Mark B', 'Initials': 'MB', 'LastName': 'Johnson', 'Affiliation': 'Pacific Institute for Research and Evaluation, Calverton, Maryland.'}, {'ForeName': 'David B', 'Initials': 'DB', 'LastName': 'Buller', 'Affiliation': 'Klein Buendel, Inc., Golden, Colorado.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Berteletti', 'Affiliation': 'Klein Buendel, Inc., Golden, Colorado.'}, {'ForeName': 'Veronica A', 'Initials': 'VA', 'LastName': 'Rogers', 'Affiliation': 'Prevention Research Center, Pacific Institute for Research and Evaluation, Berkeley, California.'}]",Journal of studies on alcohol and drugs,[] 477,31778659,Predictors of Improved Aerobic Capacity in Individuals With Chronic Stroke Participating in Cycling Interventions.,"OBJECTIVE To determine demographic and physiological factors that predict improvement in aerobic capacity among individuals with chronic stroke participating in cycling interventions. DESIGN Secondary analysis of data from 2 randomized clinical trials. SETTING Research laboratory. PARTICIPANTS Individuals with chronic stroke (N=44). INTERVENTIONS Participants were randomized to one of the following interventions: forced aerobic exercise and upper extremity repetitive task practice (FE+UERTP, n=16), voluntary aerobic exercise and upper extremity repetitive task practice (VE+UERTP, n=15), or a nonaerobic control group (control, n=13). All interventions were time-matched and occurred 3 times per week for 8 weeks. MAIN OUTCOME MEASURE Aerobic capacity as measured by peak oxygen consumption per unit time (VO 2peak ) during maximal cardiopulmonary exercise stress testing. RESULTS Significant improvements in VO 2peak were observed from baseline to postintervention in the VE+UERTP group (P<.001). Considerable variability was observed among participants relating to postintervention change in VO 2peak . Among aerobic exercise participants, a multivariate regression analysis revealed that cycling cadence, baseline VO 2peak , and group allocation were significant predictors of change in VO 2peak . CONCLUSIONS High exercise rate (cycling cadence) appears to be an important variable in improving aerobic capacity and should be considered when prescribing aerobic exercise for individuals with chronic stroke. Those with low VO 2peak at baseline may benefit the most from aerobic interventions as it relates to cardiorespiratory fitness. Further investigation is warranted to understand the precise role of other exercise and demographic variables in the prescription of aerobic exercise for this population and their effects on secondary stroke prevention and mortality.",2020,"RESULTS Significant improvements in VO 2 peak were observed from baseline to post-intervention in the VE+RTP group (p<0.001).","['Individuals with chronic stroke (N=44', 'individuals with chronic stroke participating in cycling interventions', 'individuals with chronic stroke']","['High exercise rate (cycling cadence', 'aerobic exercise', 'interventions: forced-rate aerobic exercise and upper extremity repetitive task practice (FE+RTP, n=16), voluntary-rate aerobic exercise and upper extremity repetitive task practice (VE+RTP, n=15), or a non-aerobic control', 'VE+RTP']","['peak oxygen consumption (VO 2peak ', 'aerobic capacity', 'VO 2 peak']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C3536593', 'cui_str': 'Chronic stroke'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0001701', 'cui_str': 'Exercise, Aerobic'}, {'cui': 'C0443221', 'cui_str': 'Forced (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0439656', 'cui_str': 'Voluntary (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C1305742', 'cui_str': 'Oxygen consumption'}]",,0.116552,"RESULTS Significant improvements in VO 2 peak were observed from baseline to post-intervention in the VE+RTP group (p<0.001).","[{'ForeName': 'Susan M', 'Initials': 'SM', 'LastName': 'Linder', 'Affiliation': 'Department of Biomedical Engineering, Cleveland Clinic, Cleveland, Ohio; Concussion Center, Cleveland Clinic, Cleveland, Ohio; Department of Physical Medicine and Rehabilitation, Cleveland Clinic, Cleveland, Ohio. Electronic address: linders@ccf.org.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Davidson', 'Affiliation': 'Concussion Center, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Anson', 'Initials': 'A', 'LastName': 'Rosenfeldt', 'Affiliation': 'Department of Biomedical Engineering, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Penko', 'Affiliation': 'Department of Biomedical Engineering, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Mandy Miller', 'Initials': 'MM', 'LastName': 'Koop', 'Affiliation': 'Department of Biomedical Engineering, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Dermot', 'Initials': 'D', 'LastName': 'Phelan', 'Affiliation': 'Sports Cardiology Center, Heart and Vascular Institute, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Jay L', 'Initials': 'JL', 'LastName': 'Alberts', 'Affiliation': 'Department of Biomedical Engineering, Cleveland Clinic, Cleveland, Ohio; Concussion Center, Cleveland Clinic, Cleveland, Ohio; Center for Neurologic Restoration, Cleveland Clinic, Cleveland, Ohio.'}]",Archives of physical medicine and rehabilitation,['10.1016/j.apmr.2019.10.187'] 478,31450171,"Afatinib as second-line treatment in patients with recurrent/metastatic squamous cell carcinoma of the head and neck: Subgroup analyses of treatment adherence, safety and mode of afatinib administration in the LUX-Head and Neck 1 trial.","OBJECTIVES Patients with head and neck squamous cell carcinoma (HNSCC) can experience severe symptom burden and/or difficulty swallowing, leading to problems with treatment adherence/administration. In LUX-Head and Neck 1 (LH&N1; NCT01345682), second-line afatinib improved progression-free survival (PFS) versus methotrexate in patients with recurrent/metastatic HNSCC. We report adherence and safety across pre-specified and additional subgroups potentially linked to afatinib PFS benefit in LH&N1 (p16 status, smoking history), and afatinib adherence, safety and efficacy by administration (oral versus feeding tube; post-hoc analysis). METHODS Patients were randomized (2:1) to afatinib (40 mg/day) or intravenous methotrexate (40 mg/m 2 /week). RESULTS Among 320 afatinib-treated and 160 methotrexate-treated patients, 83-92% and 76-92% (of patients with data available) across all subgroups took ≥80% of treatment. Across p16 status and smoking history subgroups, the most common treatment-related adverse events (AEs) were diarrhea (70-91%), rash/acne (72-84%), stomatitis (34-73%) with afatinib; and included stomatitis (39-100%), fatigue (22-50%), nausea (19-36%) with methotrexate. Dose reduction decreased AE incidence/severity. Baseline characteristics were generally similar between oral/feeding tube (n = 276/n = 46) groups. 89%/89% (of patients with data available) took ≥80% of assigned afatinib. Median PFS was 2.6 versus 2.7 months (hazard ratio: 0.997; 95% confidence interval: 0.72-1.38). The most common afatinib-related AEs were: rash/acne (74% versus 74%), diarrhea (73% versus 65%), stomatitis (40% versus 30%). CONCLUSION Subgroup analyses of LH&N1 demonstrate that afatinib has predictable and manageable safety across patient subgroups, with high treatment adherence, and is effective via oral and feeding tube administration.",2019,Median PFS was 2.6 versus 2.7 months (hazard ratio: 0.997; 95% confidence interval: 0.72-1.38).,"['Patients', 'patients with recurrent/metastatic squamous cell carcinoma of the head and neck', 'patients with recurrent/metastatic HNSCC', 'Patients with head and neck squamous cell carcinoma (HNSCC']","['afatinib', 'methotrexate', 'intravenous methotrexate', 'Afatinib']","['fatigue', 'stomatitis', 'rash/acne', 'nausea', 'included stomatitis', 'Median PFS', 'progression-free survival (PFS', 'AE incidence/severity', 'diarrhea', 'afatinib adherence, safety and efficacy']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0334246', 'cui_str': 'Squamous cell carcinoma, metastatic (morphologic abnormality)'}, {'cui': 'C0018670', 'cui_str': 'Head'}, {'cui': 'C0027536', 'cui_str': 'Necking (finding)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C1168401', 'cui_str': 'Squamous cell carcinoma of head and neck (disorder)'}]","[{'cui': 'C2987648', 'cui_str': 'Afatinib'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}]","[{'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0038362', 'cui_str': 'Stomatitis'}, {'cui': 'C0015230', 'cui_str': 'Skin Rash'}, {'cui': 'C0702166', 'cui_str': 'Acne'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C2987648', 'cui_str': 'Afatinib'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.102395,Median PFS was 2.6 versus 2.7 months (hazard ratio: 0.997; 95% confidence interval: 0.72-1.38).,"[{'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Haddad', 'Affiliation': ""Department of Medical Oncology, Dana-Farber Cancer Institute, Harvard Medical School and Department of Medicine, Brigham and Women's Hospital, Boston, MA, USA. Electronic address: robert_haddad@dfci.harvard.edu.""}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Guigay', 'Affiliation': ""Centre Antoine Lacassagne, FHU OncoAge, Université Côte d'Azur, Nice, France.""}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Keilholz', 'Affiliation': 'Medical Department, Charité Comprehensive Cancer Center, Berlin, Germany.'}, {'ForeName': 'Paul M', 'Initials': 'PM', 'LastName': 'Clement', 'Affiliation': 'Department of Oncology, KU Leuven, Leuven Cancer Institute, Leuven, Belgium.'}, {'ForeName': 'Jérôme', 'Initials': 'J', 'LastName': 'Fayette', 'Affiliation': 'Medical Oncology, Centre Léon Bérard, Lyon, France.'}, {'ForeName': 'Luciano', 'Initials': 'L', 'LastName': 'de Souza Viana', 'Affiliation': 'Department of Medical Oncology, Hospital de Câncer de Barretos, Barretos, São Paulo, Brazil.'}, {'ForeName': 'Frédéric', 'Initials': 'F', 'LastName': 'Rolland', 'Affiliation': ""Department of Medical Oncology, Institut de Cancérologie de l'Ouest, Nantes, France.""}, {'ForeName': 'Didier', 'Initials': 'D', 'LastName': 'Cupissol', 'Affiliation': ""Institut du Cancer de Montpellier Val d'Aurelle, Montpellier, France.""}, {'ForeName': 'Lionnel', 'Initials': 'L', 'LastName': 'Geoffrois', 'Affiliation': 'Department of Medical Oncology, Institut de Cancérologie de Lorraine, Vandœuvre-lès-Nancy, France.'}, {'ForeName': 'Gabriela', 'Initials': 'G', 'LastName': 'Kornek', 'Affiliation': 'Klinische Abteilung für Onkologie, Universitätsklinik für Innere Medizin, Vienna, Austria.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Licitra', 'Affiliation': 'Department of Head and Neck Medical Oncology, Fondazione IRCCS Istituto Nazionale Tumori, and University of Milan, Milan, Italy.'}, {'ForeName': 'Bohuslav', 'Initials': 'B', 'LastName': 'Melichar', 'Affiliation': 'Department of Oncology, Palacky University Medical School, Olomouc, Czech Republic.'}, {'ForeName': 'Ulisses', 'Initials': 'U', 'LastName': 'Ribaldo Nicolau', 'Affiliation': 'Department of Oncology, AC Camargo Cancer Center, São Paulo, SP, Brazil.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Rauch', 'Affiliation': 'Swiss Group for Clinical Cancer Research, Bern, Switzerland.'}, {'ForeName': 'Sylvie', 'Initials': 'S', 'LastName': 'Zanetta-Devauges', 'Affiliation': ""Service d'Oncologie Médicale, Centre Georges François Leclerc, Dijon Cedex, France.""}, {'ForeName': 'Ezra E W', 'Initials': 'EEW', 'LastName': 'Cohen', 'Affiliation': 'Moores Cancer Center, University of California San Diego, La Jolla, CA, USA.'}, {'ForeName': 'Jean-Pascal', 'Initials': 'JP', 'LastName': 'Machiels', 'Affiliation': ""Institut Roi Albert II, Service d'Oncologie Médicale, Cliniques Universitaires Saint-Luc and Institut de Recherche Clinique et Expérimentale (Pole MIRO), Université Catholique de Louvain, Brussels, Belgium.""}, {'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Tahara', 'Affiliation': 'Department of Head and Neck Medical Oncology, National Cancer Center Hospital East, Kashiwa, Japan.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Vermorken', 'Affiliation': 'Department of Medical Oncology, Antwerp University Hospital, Edegem, Belgium.'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Geng', 'Affiliation': 'Boehringer Ingelheim (China) Investment Co., Ltd., Shanghai, China.'}, {'ForeName': 'Eleftherios', 'Initials': 'E', 'LastName': 'Zografos', 'Affiliation': 'Boehringer Ingelheim Ltd., Berkshire, UK.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Gauler', 'Affiliation': 'Department of Medicine, West German Cancer Center, University Hospital Essen of the University Duisburg-Essen, Essen, Germany.'}]",Oral oncology,['10.1016/j.oraloncology.2019.08.004'] 479,30226112,A Comparative Effectiveness Trial of Depression Collaborative Care: Subanalysis of Comorbid Anxiety.,"The purpose of this exploratory subanalysis was to compare the effects of two depression quality improvement approaches on clinical outcomes and service utilization for individuals with comorbid depression/anxiety. This study used data from Community Partners in Care (CPIC), a cluster-randomized comparative effectiveness trial ( N = 1,018; depression = 360; comorbid depression/anxiety = 658). Each intervention arm received the same quality improvement materials, plus either technical support (Resources for Services, RS) or support for collaborative implementation planning (Community Engagement and Planning, CEP). For the comorbid depression/anxiety subgroup, the collaborative planning arm was superior at improving mental health-related quality of life and mental wellness, as well as decreasing behavioral hospitalizations and homelessness risk at 6 months. The effects were not significant at 12 months. A collaborative planning process versus technical support for depression quality improvement can have short-term effects on mental wellness and social determinants of health among those with comorbid depression/anxiety.",2019,"For the comorbid depression/anxiety subgroup, the collaborative planning arm was superior at improving mental health-related quality of life and mental wellness, as well as decreasing behavioral hospitalizations and homelessness risk at 6 months.","['individuals with comorbid depression/anxiety', 'Community Partners in Care (CPIC), a cluster-randomized comparative effectiveness trial ( N = 1,018; depression = 360; comorbid depression/anxiety = 658']","['same quality improvement materials, plus either technical support (Resources for Services, RS) or support for collaborative implementation planning (Community Engagement and Planning, CEP', 'depression quality improvement approaches']","['behavioral hospitalizations and homelessness risk', 'mental health-related quality of life and mental wellness']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0682323', 'cui_str': 'Companion'}, {'cui': 'C0580931', 'cui_str': 'In care (finding)'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C4319607', 'cui_str': '360 (qualifier value)'}]","[{'cui': 'C2936612', 'cui_str': 'Quality Improvement'}, {'cui': 'C0520510', 'cui_str': 'Material (attribute)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning (observable entity)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}]","[{'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0237154', 'cui_str': 'Homelessness'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}]",,0.0486457,"For the comorbid depression/anxiety subgroup, the collaborative planning arm was superior at improving mental health-related quality of life and mental wellness, as well as decreasing behavioral hospitalizations and homelessness risk at 6 months.","[{'ForeName': 'Kristen R', 'Initials': 'KR', 'LastName': 'Choi', 'Affiliation': '1 Division of General Internal Medicine & Health Services Research, University of California, Los Angeles, CA, USA.'}, {'ForeName': 'Cathy', 'Initials': 'C', 'LastName': 'Sherbourne', 'Affiliation': '2 RAND Corporation, Santa Monica, CA, USA.'}, {'ForeName': 'Lingqi', 'Initials': 'L', 'LastName': 'Tang', 'Affiliation': '3 David Geffen School of Medicine at UCLA, CA, USA.'}, {'ForeName': 'Enrico', 'Initials': 'E', 'LastName': 'Castillo', 'Affiliation': '5 Los Angeles County Department of Mental Health, CA, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Dixon', 'Affiliation': '6 UCLA School of Nursing, CA, USA.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Jones', 'Affiliation': '7 Charles R. Drew University of Medicine and Science, Los Angeles, CA, USA.'}, {'ForeName': 'Bowen', 'Initials': 'B', 'LastName': 'Chung', 'Affiliation': '2 RAND Corporation, Santa Monica, CA, USA.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Eisen', 'Affiliation': '5 Los Angeles County Department of Mental Health, CA, USA.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Wells', 'Affiliation': '2 RAND Corporation, Santa Monica, CA, USA.'}]",Western journal of nursing research,['10.1177/0193945918800333'] 480,32227432,Empagliflozin reduces the risk of mortality and hospitalization for heart failure across Thrombolysis In Myocardial Infarction Risk Score for Heart Failure in Diabetes categories: Post hoc analysis of the EMPA-REG OUTCOME trial.,"AIM To investigate the association of the Thrombolysis In Myocardial Infarction (TIMI) Risk Score for Heart Failure in Diabetes (TRS-HF DM ) with mortality using data from the EMPA-REG OUTCOME trial. MATERIALS AND METHODS In EMPA-REG OUTCOME, patients with type 2 diabetes and atherosclerotic cardiovascular (CV) disease (N = 7020) received the sodium-glucose co-transporter-2 inhibitor, empagliflozin, 10 or 25 mg or placebo. Post hoc, patients were stratified into risk categories (low-intermediate, high, very-high risk scores) using baseline TRS-HF DM . Cox regression analyses evaluated the association of TRS-HF DM categories with all-cause mortality (ACM), CV death, hospitalization for heart failure (HHF) and CV death (excluding fatal stroke) or HHF, and whether empagliflozin reduced the risk of CV outcomes across these risk categories. RESULTS In placebo patients, increasing risk category was associated with a higher risk of ACM, CV death, and HHF. Empagliflozin reduced the risk of ACM (low-intermediate HR 0.68 [95% CI 0.48, 0.97] and very-high 0.69 [0.52, 0.91]), CV death (0.75 [0.48, 1.18] and 0.56 [0.41, 0.78]), HHF (0.53 [0.28, 1.01] and 0.67 [0.48, 0.96]), and CV death or HHF (0.69 [0.46, 1.03]) and (0.64 [0.49, 0.82]) across all risk categories versus placebo. Higher absolute risk reductions (ARRs) were observed for CV death in the very-high versus low-intermediate category (P = 0.01). CONCLUSIONS Applied to EMPA-REG OUTCOME, higher TRS-HF DM was associated with increased HHF and mortality risk. Empagliflozin reduced CV outcomes across TRS-HF DM categories. Higher ARRs were associated with higher risk scores.",2020,"Higher absolute risk reductions (ARRs) were observed for CV death in the very-high versus low-intermediate category (P = 0.01). ","['patients with type 2 diabetes and atherosclerotic cardiovascular (CV) disease (N = 7020', 'Heart Failure in Diabetes categories', 'Diabetes']","['Empagliflozin', 'placebo', 'Thrombolysis', 'sodium-glucose co-transporter-2 inhibitor, empagliflozin, 10 or 25\u2009mg or placebo', 'empagliflozin']","['risk of CV outcomes', 'CV death', 'HHF and mortality risk', 'Myocardial Infarction (TIMI', 'HHF', 'higher risk of ACM, CV death, and HHF', 'risk of mortality and hospitalization for heart failure across Thrombolysis', 'CV death or HHF', 'TRS-HF DM categories with all-cause mortality (ACM), CV death, hospitalization for heart failure (HHF) and CV death (excluding fatal stroke) or HHF', 'risk of ACM', 'Higher absolute risk reductions (ARRs']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0004153', 'cui_str': 'Atherosclerosis'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}]","[{'cui': 'C3490348', 'cui_str': 'empagliflozin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0520997', 'cui_str': 'Thrombolysis, function (observable entity)'}, {'cui': 'C4301634', 'cui_str': 'Sodium-glucose co-transporter 2 (SGLT2) inhibitors'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0332167', 'cui_str': 'High risk of (contextual qualifier) (qualifier value)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0520997', 'cui_str': 'Thrombolysis, function (observable entity)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C3179139', 'cui_str': 'Absolute Risk Reduction'}]",,0.169317,"Higher absolute risk reductions (ARRs) were observed for CV death in the very-high versus low-intermediate category (P = 0.01). ","[{'ForeName': 'Subodh', 'Initials': 'S', 'LastName': 'Verma', 'Affiliation': ""Division of Cardiac Surgery, St. Michael's Hospital, University of Toronto, Toronto, Ontario, Canada.""}, {'ForeName': 'Abhinav', 'Initials': 'A', 'LastName': 'Sharma', 'Affiliation': 'McGill University Health Centre, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Zinman', 'Affiliation': 'Lunenfeld-Tanenbaum Research Institute, Mount Sinai Hospital, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Anne Pernille', 'Initials': 'AP', 'LastName': 'Ofstad', 'Affiliation': 'Boehringer Ingelheim Norway KS, Asker, Norway.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Fitchett', 'Affiliation': ""Division of Cardiology, St. Michael's Hospital, University of Toronto, Toronto, Ontario, Canada.""}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Brueckmann', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Wanner', 'Affiliation': 'Würzburg University Clinic, Würzburg, Germany.'}, {'ForeName': 'Isabella', 'Initials': 'I', 'LastName': 'Zwiener', 'Affiliation': 'Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, Germany.'}, {'ForeName': 'Jyothis T', 'Initials': 'JT', 'LastName': 'George', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim, Germany.'}, {'ForeName': 'Silvio E', 'Initials': 'SE', 'LastName': 'Inzucchi', 'Affiliation': 'Yale University School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Javed', 'Initials': 'J', 'LastName': 'Butler', 'Affiliation': 'Department of Medicine, University of Mississippi Medical Center, Jackson, Mississippi.'}, {'ForeName': 'C David', 'Initials': 'CD', 'LastName': 'Mazer', 'Affiliation': ""Department of Anesthesia, St. Michael's Hospital, University of Toronto, Toronto, Ontario, Canada.""}]","Diabetes, obesity & metabolism",['10.1111/dom.14015'] 481,32224119,Effectiveness of Manual and Electrical Acupuncture for Chronic Non-specific Low Back Pain: A Randomized Controlled Trial.,"BACKGROUND Low back pain is a common condition that can be effectively treated by acupuncture. However, several treatment point prescriptions and further electrical needle stimulation (i.e., local acupoints, distal acupoints, and sensitized acupoints) may be used. There is an implicit yet unexplored assumption about the evidence on manual and electrical stimulation techniques. OBJECTIVE The present study aims to identify effectiveness of electroacupuncture (EA) and manual acupuncture (MA) on pain and disability in patients with chronic nonspecific low back. METHODS This study is a randomized controlled clinical trial. Sixty-six patients between 20 and 60 years of age with non-specific chronic low back pain experiencing low back pain lasting for at least the previous three months and ≥3 points on a 10 numerical analogic scale. Patients diagnosed with chronic LBP were assigned to receive either 12 sessions of MA or EA. The primary outcomes measurements were pain intensity on Numeric Rating Scale and disability by Roland Morris Disability Questionnaire. RESULTS The participants reported improvements post-treatment to pain intensity and disability respectively; however, no differences between groups were observed. Regarding the secondary outcomes, we observed a between-group difference only for kinesiophobia in favor of the manual acupuncture group (difference = -4.1 points, 95% CI = -7.0 to -1.1). The results were maintained after 3 months of follow-up. CONCLUSION The study provides evidence that EA is not superior to MA treatment. Both therapies had similar efficacy in reducing pain and disability for chronic nonspecific low back pain.",2020,"Regarding the secondary outcomes, we observed a between-group difference only for kinesiophobia in favor of the manual acupuncture group (difference = -4.1 points, 95% CI = -7.0 to -1.1).","['chronic nonspecific low back pain', 'patients with chronic low back', '66 randomly allocated patients diagnosed with chronic LBP']","['manual and electrical needle stimulation', 'electroacupuncture (EA) and manual acupuncture (MA', 'acupuncture or electr LINK Word', 'acupuncture', 'electroacupuncture']","['intensity pain and disability', 'intensity pain (NRS) and disability (RMQ', 'pain and disability', 'kinesiophobia']","[{'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0024031', 'cui_str': 'Low Back Ache'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2939142', 'cui_str': 'Lower back (surface region)'}]","[{'cui': 'C0175674', 'cui_str': 'Manual (qualifier value)'}, {'cui': 'C0442828', 'cui_str': 'Electrical (qualifier value)'}, {'cui': 'C0398296', 'cui_str': 'Cannulation of vascular fistula, graft or prosthetic device (procedure)'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0013794', 'cui_str': 'Electroacupuncture'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}]","[{'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C4285782', 'cui_str': 'Kinesiophobia'}]",66.0,0.286124,"Regarding the secondary outcomes, we observed a between-group difference only for kinesiophobia in favor of the manual acupuncture group (difference = -4.1 points, 95% CI = -7.0 to -1.1).","[{'ForeName': 'Josielli', 'Initials': 'J', 'LastName': 'Comachio', 'Affiliation': 'Physical Therapy, Speech and Occupational Therapy Department, School of Medicine, University of Sao Paulo, Sao Paulo, Brazil. Electronic address: josiecomachio@gmail.com.'}, {'ForeName': 'Carla C', 'Initials': 'CC', 'LastName': 'Oliveira', 'Affiliation': 'Physical Therapy, Speech and Occupational Therapy Department, School of Medicine, University of Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Ilton F R', 'Initials': 'IFR', 'LastName': 'Silva', 'Affiliation': 'Physical Therapy, Speech and Occupational Therapy Department, School of Medicine, University of Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Mauricio O', 'Initials': 'MO', 'LastName': 'Magalhães', 'Affiliation': 'Physical Therapy, Speech and Occupational Therapy Department, School of Medicine, University of Sao Paulo, Sao Paulo, Brazil; Physical Therapy, Speech and Occupational Therapy Department, University of Para, Belem, Brazil.'}, {'ForeName': 'Amélia P', 'Initials': 'AP', 'LastName': 'Marques', 'Affiliation': 'Physical Therapy, Speech and Occupational Therapy Department, School of Medicine, University of Sao Paulo, Sao Paulo, Brazil.'}]",Journal of acupuncture and meridian studies,['10.1016/j.jams.2020.03.064'] 482,31485929,"Surgeon-delivered laparoscopic transversus abdominis plane blocks are non-inferior to anesthesia-delivered ultrasound-guided transversus abdominis plane blocks: a blinded, randomized non-inferiority trial.","BACKGROUND The transversus abdominis plane (TAP) block is an important non-narcotic adjunct for post-operative pain control in abdominal surgery. Surgeons can use laparoscopic guidance for TAP block placement (LTAP), however, direct comparisons to conventional ultrasound-guided TAP (UTAPs) have been lacking. The aim of this study is to determine if surgeon placed LTAPs were non-inferior to anesthesia placed UTAPs for post-operative pain control in laparoscopic colorectal surgery. METHODS This was a prospective, randomized, patient and observer blinded parallel-arm non-inferiority trial conducted at a single tertiary academic center between 2016 and 2018 on adult patients undergoing laparoscopic colorectal surgery. Narcotic consumption and pain scores were compared for LTAP vs. UTAP for 48 h post-operatively. RESULTS 60 patients completed the trial (31 UTAP, 29 LTAP) of which 25 patients were female (15 UTAP, 10 LTAP) and the mean ages (SD) were 60.0 (13.6) and 61.5 (14.3) in the UTAP and LTAP groups, respectively. There was no significant difference in post-operative narcotic consumption between UTAP and LTAP at the time of PACU discharge (median [IQR] milligrams of morphine, 1.8 [0-4.5] UTAP vs. 0 [0-8.7] LTAP P = .32), 6 h post-operatively (5.4 [1.8-17.1] UTAP vs. 3.6 [0-12.6] LTAP P = .28), at 12 h post-operatively (9.0 [3.6-29.4] UTAP vs. 7.2 [0.9-22.5] LTAP P = .51), at 24 h post-operatively (9.0 [3.6-29.4] UTAP vs. 7.2 [0.9-22.5] LTAP P = .63), and 48 h post-operatively (39.9 [7.5-70.2] UTAP vs. 22.2 [7.5-63.8] LTAP P = .41). Patient-reported pain scores as well as pre-, intra-, and post-operative course were similar between groups. Non-inferiority criteria were met at all post-op time points up to and including 24 h but not at 48 h. CONCLUSIONS Surgeon-delivered LTAPs are safe, effective, and non-inferior to anesthesia-administered UTAPs in the immediate post-operative period. TRIAL REGISTRY The trial was registered at clinicaltrials.gov Identifier NCT03577912.",2020,"inferiority criteria were met at all post-op time points up to and including 24 h but not at 48 h. CONCLUSIONS Surgeon-delivered LTAPs are safe, effective, and non-inferior to anesthesia-administered UTAPs in the immediate post-operative period. ","['patient and observer blinded parallel-arm non-inferiority trial conducted at a single tertiary academic center between 2016 and 2018 on adult patients undergoing', '60 patients completed the trial (31 UTAP, 29 LTAP) of which 25 patients were female (15 UTAP, 10 LTAP) and the mean ages (SD) were 60.0 (13.6) and 61.5 (14.3) in the UTAP and LTAP groups, respectively']","['LTAP vs. UTAP', 'Surgeon-delivered laparoscopic transversus abdominis plane blocks', 'laparoscopic guidance for TAP block placement (LTAP', 'conventional ultrasound-guided TAP (UTAPs', 'anesthesia-delivered ultrasound-guided transversus abdominis plane blocks', 'laparoscopic colorectal surgery', 'transversus abdominis plane (TAP) block']","['pain scores', 'time of PACU discharge', 'Narcotic consumption and pain scores', 'post-operative narcotic consumption']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C4505128', 'cui_str': 'Noninferiority Trial'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0205372', 'cui_str': 'Tertiary (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517560', 'cui_str': '13.6'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0582175', 'cui_str': 'Surgeon (occupation)'}, {'cui': 'C0444660', 'cui_str': 'Plane (attribute)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0034115', 'cui_str': 'Puncture and Drainage'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C0009369', 'cui_str': 'Colon and Rectal Surgery Specialty'}]","[{'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0034871', 'cui_str': 'Hospital Recovery Rooms'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0027415', 'cui_str': 'Narcotics'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}]",60.0,0.348947,"inferiority criteria were met at all post-op time points up to and including 24 h but not at 48 h. CONCLUSIONS Surgeon-delivered LTAPs are safe, effective, and non-inferior to anesthesia-administered UTAPs in the immediate post-operative period. ","[{'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Wong', 'Affiliation': 'Division of Colon & Rectum Surgery, Beth Israel Lahey Health Medical Center, Harvard Medical School, Boston, MA, 02215, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Curran', 'Affiliation': 'Division of Colon & Rectum Surgery, Beth Israel Lahey Health Medical Center, Harvard Medical School, Boston, MA, 02215, USA.'}, {'ForeName': 'Vitaliy Y', 'Initials': 'VY', 'LastName': 'Poylin', 'Affiliation': 'Division of Colon & Rectum Surgery, Beth Israel Lahey Health Medical Center, Harvard Medical School, Boston, MA, 02215, USA.'}, {'ForeName': 'Thomas E', 'Initials': 'TE', 'LastName': 'Cataldo', 'Affiliation': 'Division of Colon & Rectum Surgery, Beth Israel Lahey Health Medical Center, Harvard Medical School, Boston, MA, 02215, USA. Tcatald1@bidmc.harvard.edu.'}]",Surgical endoscopy,['10.1007/s00464-019-07097-y'] 483,30637887,Pilot Trial of an Emergency Department-based Intervention to Promote Child Passenger Safety Best Practices.,"BACKGROUND Despite demonstrated effectiveness of child restraint systems (CRSs), use remains suboptimal. In this randomized pilot trial, we sought to determine the feasibility, acceptability, and potential efficacy of ""Tiny Cargo, Big Deal"" an ED-based intervention to promote guideline-concordant size-appropriate CRS use. METHODS Parents of children < 11 years old were recruited in two EDs and randomized in a 2 × 2 factorial design to four conditions: 1) generic information sheet, 2) tailored brochure mailed after the ED visit, 3) a single motivational interviewing-based counseling session in the ED, and 4) full intervention (counseling session plus tailored brochure). We assessed feasibility (recruitment, completion, follow-up rates) and acceptability (parent attitudes, uptake of information) in the ED, at 1 month and at 6 months. We obtained preliminary estimates of effect sizes of the intervention components on appropriate CRS use at 6-month follow-up. RESULTS Of the 514 parents assessed for eligibility, 456 met inclusion criteria and 347 consented to participate. Enrolled parents were mostly mothers (88.1%); 48.7% were 18 to 29 years old; 52.5% were non-Hispanic, white; and 65.2% reported size-appropriate CRS use. Completion rates were 97.7% for baseline survey, 81.6% for counseling, 51.9% for 1-month follow-up, and 59.3% for 6-month follow-up. In the ED, 70.5% rated thinking about child passenger safety in the ED as very helpful. At 1 month, 70.0% expressed positive attitudes toward the study. Of 132 parents who reported receiving study mailings, 78.9% reviewed the information. Parents randomized to the full intervention demonstrated an increase (+6.12 percentage points) and other groups a decrease (-1.69 to -9.3 percentage points) in the proportion of children reported to use a size-appropriate CRS at 6-month follow-up. CONCLUSIONS Suboptimal CRS use can be identified and intervened upon during a child's ED visit. A combined approach with ED-based counseling and mailed tailored brochures shows promise to improve size-appropriate CRS use.",2019,"Parents randomized to the full intervention demonstrated an increase (+6.12 percentage points) and other groups a decrease (-1.69 to -9.3 percentage points) in the proportion of children reported to use a size-appropriate CRS at 6-month follow-up. ","['Parents of children\xa0<\xa011 years old', '132 parents who reported receiving study mailings, 78.9% reviewed the information', 'Of the 514 parents assessed for eligibility, 456 met inclusion criteria and 347 consented to participate', 'Enrolled parents were mostly mothers (88.1%); 48.7% were 18 to 29 years old; 52.5% were non-Hispanic, white; and 65.2% reported size-appropriate CRS use']","['child restraint systems (CRSs', 'generic information sheet, 2) tailored brochure mailed after the ED visit, 3) a single motivational interviewing-based counseling session in the ED, and 4) full intervention (counseling session plus tailored brochure', 'Emergency Department-based Intervention', 'ED-based counseling and mailed tailored brochures']","['feasibility (recruitment, completion, follow-up rates) and acceptability (parent attitudes, uptake of information', 'Completion rates']","[{'cui': 'C0030551', 'cui_str': 'Parent of (observable entity)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C4517802', 'cui_str': '52.5 (qualifier value)'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C1947944', 'cui_str': 'Use'}]","[{'cui': 'C2718030', 'cui_str': 'Child Restraint Systems'}, {'cui': 'C0439643', 'cui_str': 'Sheets (qualifier value)'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0024492', 'cui_str': 'Mail'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}]","[{'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}]",514.0,0.0669276,"Parents randomized to the full intervention demonstrated an increase (+6.12 percentage points) and other groups a decrease (-1.69 to -9.3 percentage points) in the proportion of children reported to use a size-appropriate CRS at 6-month follow-up. ","[{'ForeName': 'Michelle L', 'Initials': 'ML', 'LastName': 'Macy', 'Affiliation': 'Department of Emergency Medicine, Michigan Medicine, Ann Arbor, MI.'}, {'ForeName': 'Deepika', 'Initials': 'D', 'LastName': 'Kandasamy', 'Affiliation': 'The Child Health Evaluation and Research (CHEAR) Center, Division of General Pediatrics, Ann Arbor, MI.'}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Resnicow', 'Affiliation': 'School of Public Health, University of Michigan, Ann Arbor, MI.'}, {'ForeName': 'Rebecca M', 'Initials': 'RM', 'LastName': 'Cunningham', 'Affiliation': 'Department of Emergency Medicine, Michigan Medicine, Ann Arbor, MI.'}]",Academic emergency medicine : official journal of the Society for Academic Emergency Medicine,['10.1111/acem.13687'] 484,32203971,Interactive Motion-Assisted Exposure Therapy for Veterans with Treatment-Resistant Posttraumatic Stress Disorder: A Randomized Controlled Trial.,"BACKGROUND Veterans with posttraumatic stress disorder (PTSD) tend to benefit less from evidence-based treatments than other PTSD populations. A novel virtual reality and motion-assisted exposure therapy, called 3MDR, provides treatment in an immersive, personalized and activating context. OBJECTIVE To study the efficacy of 3MDR for veterans with treatment-resistant PTSD. METHOD In a randomized controlled trial (n = 43) 3MDR was compared to a non-specific treatment component control group. Primary outcome was clinician-rated PTSD symptoms at baseline, after 3MDR, and at the 12-week and 16-week follow-up (primary end point). Intention-to-treat analyses of covariance and mixed models were applied to study differences between groups at the end point and over the course of intervention, controlling for baseline scores. RESULTS The decrease in PTSD symptom severity from baseline to end point was significantly greater for 3MDR as compared to the control group, with a large effect size (F[1, 37] = 6.43, p = 0.016, d = 0.83). No significant between-group difference was detected in the course of PTSD symptoms during treatment when including all time points. The dropout rate was low (7%), and 45% of the patients in the 3MDR group improved clinically. The number needed to treat was 2.86. CONCLUSIONS In this trial, 3MDR significantly decreased PTSD symptoms in veterans with, on average, a history of 4 unsuccessful treatments. The low dropout rate may be indicative of high engagement. However, a lack of significant differences on secondary outcomes limits conclusions that can be drawn on its efficacy and underlines the need for larger phase III trials. These data show emerging evidence for 3MDR and its potential to progress PTSD treatment for veterans (Dutch Trial Register Identifier: NL5126).",2020,"The decrease in PTSD symptom severity from baseline to end point was significantly greater for 3MDR as compared to the control group, with a large effect size (F[1, 37] = 6.43, p = 0.016, d = 0.83).","['Veterans with Treatment-Resistant Posttraumatic Stress Disorder', 'veterans with treatment-resistant PTSD', 'n = 43', 'Veterans with posttraumatic stress disorder (PTSD']","['Interactive Motion-Assisted Exposure Therapy', '3MDR']","['PTSD symptoms', 'PTSD symptom severity', 'dropout rate', 'course of PTSD symptoms', '3MDR', 'clinician-rated PTSD symptoms']","[{'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332325', 'cui_str': 'Resistant (qualifier value)'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}]","[{'cui': 'C0687704', 'cui_str': 'Motions (qualifier value)'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0870527', 'cui_str': 'Exposure Therapy'}]","[{'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity (finding)'}, {'cui': 'C0750729', 'cui_str': 'Courses (qualifier value)'}]",,0.0316866,"The decrease in PTSD symptom severity from baseline to end point was significantly greater for 3MDR as compared to the control group, with a large effect size (F[1, 37] = 6.43, p = 0.016, d = 0.83).","[{'ForeName': 'Marieke J', 'Initials': 'MJ', 'LastName': 'van Gelderen', 'Affiliation': ""ARQ Centrum'45, Diemen, The Netherlands, m.van.gelderen@centrum45.nl.""}, {'ForeName': 'Mirjam J', 'Initials': 'MJ', 'LastName': 'Nijdam', 'Affiliation': ""ARQ Centrum'45, Diemen, The Netherlands.""}, {'ForeName': 'Joris F G', 'Initials': 'JFG', 'LastName': 'Haagen', 'Affiliation': 'ARQ Centre of Expertise Impact, Diemen, The Netherlands.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Vermetten', 'Affiliation': 'Department of Psychiatry, Leiden University Medical Center, Leiden, The Netherlands.'}]",Psychotherapy and psychosomatics,['10.1159/000505977'] 485,31904342,Association Between Exercise Capacity and Health-Related Quality of Life During and After Cardiac Rehabilitation in Acute Coronary Syndrome Patients: A Substudy of the OPTICARE Randomized Controlled Trial.,"OBJECTIVE To examine the strength of the association between exercise capacity and health-related quality of life (HRQOL) during and after cardiac rehabilitation (CR) in patients with acute coronary syndrome (ACS) who completed CR. DESIGN Prospective cohort study. SETTING Outpatient CR center. PARTICIPANTS Patients (N=607) with ACS who completed CR. INTERVENTIONS Multidisciplinary 12-week exercise-based CR program. MAIN OUTCOME MEASURES At baseline (pre-CR), the 6-Minute Walk Test (6MWT) was performed to determine exercise capacity, and the MacNew Heart Disease Health-related Quality of Life questionnaire was used to assess HRQOL. Measurements were repeated immediately after completion of CR (post-CR): at 12 months and 18 months follow-up. Multivariable linear regression, including an interaction term for time and exercise capacity, was applied to study the association between exercise capacity and HRQOL at different time points relative to CR, whereas model parameters were estimated by methods that accounted for dependency of repeated observations within individuals. RESULTS Mean age in years ± SD was 58±8.9 and 82% of participants were male. Baseline mean 6MWT distance in meters ± SD was 563±77 and median (25th-75th percentile) global HRQOL was 5.5 (4.6-6.1) points. Mean 6MWT distance (P<.001) and the global (P<.001), physical (P<.001), emotional (P<.001) and social (P<.001) domains of HRQOL improved significantly during CR and continued to improve during follow-up post-CR. Independent of the timing relative to CR (ie, pre-CR, post-CR, or during follow-up), a difference of 10 m 6MWT distance was associated with a mean difference in the global HRQOL domain of 0.007 (95% confidence interval [CI], 0.001-0.014) points (P=.029) and a mean difference in the physical domain of 0.009 (95% CI, 0.001-0.017) points (P=.023). CONCLUSIONS Better exercise capacity was significantly associated with higher scores on the global and physical domains of HRQOL, irrespective of the timing relative to CR, albeit these associations were weak. Hence, CR programs in secondary prevention should continue to aim at enhancing both HRQOL and exercise capacity.",2020,"Mean 6MWT distance(P<0.001) and the global(P<0.001), physical(P<0.001), emotional(P<0.001) and social(P<0.001) domains of HRQOL improved significantly during CR and continued to improve during follow-up post-CR.","['Mean(standard deviation) age was 58(8.9) years and 82% were male', 'Patients(N=607) with ACS who completed CR', 'Acute Coronary Syndrome Patients', 'Outpatient CR center', 'patients with acute coronary syndrome (ACS), who completed CR']","['cardiac rehabilitation (CR', 'Multidisciplinary 12-week exercise-based CR program']","['exercise capacity, and the MacNew Heart Disease Health-related Quality of Life questionnaire', 'global HRQOL', 'At baseline(pre-CR), the six-minute walk test(6MWT', 'Mean 6MWT distance(P<0.001) and the global(P<0.001), physical(P<0.001), emotional(P<0.001) and social(P<0.001) domains of HRQOL', 'Exercise Capacity and Health-Related Quality of Life']","[{'cui': 'C0012727', 'cui_str': 'Displacement (morphologic abnormality)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0948089', 'cui_str': 'Acute Coronary Syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]","[{'cui': 'C0700431', 'cui_str': 'Cardiovascular Rehabilitation'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0018799', 'cui_str': 'Cardiac Diseases'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C3541951', 'cui_str': 'Domain'}]",607.0,0.127582,"Mean 6MWT distance(P<0.001) and the global(P<0.001), physical(P<0.001), emotional(P<0.001) and social(P<0.001) domains of HRQOL improved significantly during CR and continued to improve during follow-up post-CR.","[{'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'de Bakker', 'Affiliation': 'Department of Cardiology, Erasmus MC, University Medical Center Rotterdam, Rotterdam. Electronic address: m.debakker@erasmusmc.nl.'}, {'ForeName': 'Iris', 'Initials': 'I', 'LastName': 'den Uijl', 'Affiliation': 'Capri Cardiac Rehabilitation Rotterdam, Rotterdam; Department of Rehabilitation Medicine, Erasmus MC, University Medical Center Rotterdam, Rotterdam, the Netherlands.'}, {'ForeName': 'Nienke', 'Initials': 'N', 'LastName': 'Ter Hoeve', 'Affiliation': 'Capri Cardiac Rehabilitation Rotterdam, Rotterdam; Department of Rehabilitation Medicine, Erasmus MC, University Medical Center Rotterdam, Rotterdam, the Netherlands.'}, {'ForeName': 'Ron T', 'Initials': 'RT', 'LastName': 'van Domburg', 'Affiliation': 'Department of Cardiology, Erasmus MC, University Medical Center Rotterdam, Rotterdam.'}, {'ForeName': 'Marcel L', 'Initials': 'ML', 'LastName': 'Geleijnse', 'Affiliation': 'Department of Cardiology, Erasmus MC, University Medical Center Rotterdam, Rotterdam.'}, {'ForeName': 'Rita J', 'Initials': 'RJ', 'LastName': 'van den Berg-Emons', 'Affiliation': 'Department of Rehabilitation Medicine, Erasmus MC, University Medical Center Rotterdam, Rotterdam, the Netherlands.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Boersma', 'Affiliation': 'Department of Cardiology, Erasmus MC, University Medical Center Rotterdam, Rotterdam.'}, {'ForeName': 'Madoka', 'Initials': 'M', 'LastName': 'Sunamura', 'Affiliation': 'Capri Cardiac Rehabilitation Rotterdam, Rotterdam.'}]",Archives of physical medicine and rehabilitation,['10.1016/j.apmr.2019.11.017'] 486,32220283,"Safety and immunogenicity of the tetravalent, live-attenuated dengue vaccine Butantan-DV in adults in Brazil: a two-step, double-blind, randomised placebo-controlled phase 2 trial.","BACKGROUND The Butantan Institute has manufactured a lyophilised tetravalent live-attenuated dengue vaccine Butantan-DV, which is analogous to the US National Institutes of Health (NIH) TV003 admixture. We aimed to assess the safety and immunogenicity of Butantan-DV. METHODS We did a two-step, double-blind, randomised placebo-controlled phase 2 trial at two clinical sites in São Paulo, Brazil. We recruited healthy volunteers aged 18-59 years; pregnant women, individuals with a history of neurological, heart, lung, liver or kidney disease, diabetes, cancer, or autoimmune diseases, and individuals with HIV or hepatitis C were excluded. Step A was designed as a small bridge-study between Butantan-DV and TV003 in DENV-naive participants. In step A, we planned to randomly assign 50 dengue virus (DENV)-naive individuals to receive two doses of Butantan-DV, TV003, or placebo, given 6 months apart. In step B, we planned to randomly assign 250 participants (DENV-naive and DENV-exposed) to receive one dose of Butantan-DV or placebo. Participants were randomly assigned, by computer-generated block randomisation (block sizes of five); participants in step A were randomly assigned (2:2:1) to receive Butantan-DV, TV003, or placebo and participants in step B were randomly assigned (4:1) to receive Butantan-DV or placebo. Participants and study staff were unaware of treatment allocation. The primary safety outcome was the frequency of solicited and unsolicited local and systemic adverse reactions within 21 days of the first vaccination, analysed by intention to treat. The primary immunogenicity outcome was seroconversion rates of the DENV-1-4 serotypes measured 91 days after the first vaccination, analysed in the per-protocol population, which included all participants in step A, and all participants included in step B who completed all study visits with serology sample collection. This trial is registered with ClinicalTrials.gov, NCT01696422. FINDINGS Between Nov 5, 2013, and Sept 21, 2015, 300 individuals were enrolled and randomly assigned: 155 (52%) DENV-naive participants and 145 (48%) DENV-exposed participants. Of the 155 DENV-naive participants, 97 (63%) received Butantan-DV, 17 (11%) received TV003, and 41 (27%) received placebo. Of the 145 DENV-exposed participants, 113 (78%) received Butantan-DV, three (2%) received TV003, and 29 (20%) received placebo. Butantan-DV and TV003 were both immunogenic, well-tolerated, and no serious adverse reactions were observed. In step A, rash was the most frequent adverse event (16 [845] of 19 participants in the Butantan-DV group and 13 [76%] of 17 participants in the TV003 group). Viraemia was similar between the Butantan-DV and TV003 groups. Of the 85 DENV-naive participants in the Butantan-DV group who attended all visits for sample collection for seroconversion analysis and thus were included in the per-protocol analysis population, 74 (87%) achieved seroconversion to DENV-1, 78 (92%) to DENV-2, 65 (76%) to DENV-3, and 76 (89%) to DENV-4. Of the 101 DENV-exposed participants in the Butantan-DV group who attended all visits for sample collection for seroconversion analysis, 82 (81%) achieved seroconversion to DENV-1, 79 (78%) to DENV-2, 83 (82%) to DENV-3, and 78 (77%) to DENV-4. INTERPRETATION Butantan-DV and TV003 were safe and induced robust, balanced neutralising antibody responses against the four DENV serotypes. Efficacy evaluation of the Butantan-DV vaccine is ongoing. FUNDING Intramural Research Program US NIH National Institute of Allergy and Infectious Diseases, Brazilian National Bank for Economic and Social Development, Fundação de Amparo à Pesquisa do Estado de São Paulo, and Fundação Butantan.",2020,"The primary safety outcome was the frequency of solicited and unsolicited local and systemic adverse reactions within 21 days of the first vaccination, analysed by intention to treat.","['healthy volunteers aged 18-59 years; pregnant women, individuals with a history of neurological, heart, lung, liver or kidney disease, diabetes, cancer, or autoimmune diseases, and individuals with HIV or hepatitis C were excluded', 'adults in Brazil', 'Between Nov 5, 2013, and Sept 21, 2015, 300 individuals were enrolled and randomly assigned: 155 (52%) DENV-naive participants and 145 (48%) DENV-exposed participants']","['placebo', 'Butantan-DV or placebo', 'Butantan-DV, TV003, or placebo', 'tetravalent, live-attenuated dengue vaccine Butantan-DV', 'computer-generated block randomisation (block sizes of five); participants in step A were randomly assigned (2:2:1) to receive Butantan-DV, TV003, or placebo and participants in step B were randomly assigned (4:1) to receive Butantan-DV or placebo', 'Butantan-DV vaccine']","['Safety and immunogenicity', 'Viraemia', 'seroconversion to DENV-1', 'frequency of solicited and unsolicited local and systemic adverse reactions', 'seroconversion rates of the DENV-1-4 serotypes']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0205494', 'cui_str': 'Neurologic (qualifier value)'}, {'cui': 'C0018787', 'cui_str': 'Heart'}, {'cui': 'C0024109', 'cui_str': 'Lung'}, {'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C0022658', 'cui_str': 'Kidney Diseases'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0004364', 'cui_str': 'Autoimmune Diseases'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0019196', 'cui_str': 'Parenterally-Transmitted Non-A, Non-B Hepatitis'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C4517577', 'cui_str': '145'}, {'cui': 'C0332157', 'cui_str': 'Exposure to (contextual qualifier) (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1548477', 'cui_str': 'Dengue Vaccines'}, {'cui': 'C0009622', 'cui_str': 'Computers'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0042749', 'cui_str': 'Viremia'}, {'cui': 'C4042908', 'cui_str': 'Seroconversion'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction (disorder)'}, {'cui': 'C0580278', 'cui_str': '4 serotype'}]",300.0,0.486172,"The primary safety outcome was the frequency of solicited and unsolicited local and systemic adverse reactions within 21 days of the first vaccination, analysed by intention to treat.","[{'ForeName': 'Esper G', 'Initials': 'EG', 'LastName': 'Kallas', 'Affiliation': 'Department of Infectious and Parasitic Diseases, School of Medicine, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Alexander Roberto', 'Initials': 'AR', 'LastName': 'Precioso', 'Affiliation': 'Department of Infectious and Parasitic Diseases, School of Medicine, University of São Paulo, São Paulo, Brazil; Division of Clinical Trials and Pharmacovigilance, Instituto Butantan, São Paulo, Brazil. Electronic address: alexander.precioso@butantan.gov.br.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Palacios', 'Affiliation': 'Division of Clinical Trials and Pharmacovigilance, Instituto Butantan, São Paulo, Brazil.'}, {'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Thomé', 'Affiliation': 'Preventive Medicine Department, Federal University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Patrícia Emília', 'Initials': 'PE', 'LastName': 'Braga', 'Affiliation': 'Division of Clinical Trials and Pharmacovigilance, Instituto Butantan, São Paulo, Brazil.'}, {'ForeName': 'Tazio', 'Initials': 'T', 'LastName': 'Vanni', 'Affiliation': 'Division of Clinical Trials and Pharmacovigilance, Instituto Butantan, São Paulo, Brazil.'}, {'ForeName': 'Lúcia M A', 'Initials': 'LMA', 'LastName': 'Campos', 'Affiliation': 'Department of Pediatrics, School of Medicine, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Lilian', 'Initials': 'L', 'LastName': 'Ferrari', 'Affiliation': 'Division of Clinical Immunology and Allergy, School of Medicine, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Gabriella', 'Initials': 'G', 'LastName': 'Mondini', 'Affiliation': 'Division of Clinical Trials and Pharmacovigilance, Instituto Butantan, São Paulo, Brazil.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'da Graça Salomão', 'Affiliation': 'Division of Clinical Trials and Pharmacovigilance, Instituto Butantan, São Paulo, Brazil.'}, {'ForeName': 'Anderson', 'Initials': 'A', 'LastName': 'da Silva', 'Affiliation': 'Division of Clinical Trials and Pharmacovigilance, Instituto Butantan, São Paulo, Brazil.'}, {'ForeName': 'Heloisa M', 'Initials': 'HM', 'LastName': 'Espinola', 'Affiliation': 'Division of Clinical Trials and Pharmacovigilance, Instituto Butantan, São Paulo, Brazil.'}, {'ForeName': 'Joane', 'Initials': 'J', 'LastName': 'do Prado Santos', 'Affiliation': 'Division of Clinical Trials and Pharmacovigilance, Instituto Butantan, São Paulo, Brazil.'}, {'ForeName': 'Cecilia L S', 'Initials': 'CLS', 'LastName': 'Santos', 'Affiliation': 'Instituto Adolfo Lutz, São Paulo, Brazil.'}, {'ForeName': 'Maria do Carmo S T', 'Initials': 'MDCST', 'LastName': 'Timenetsky', 'Affiliation': 'Instituto Adolfo Lutz, São Paulo, Brazil.'}, {'ForeName': 'João Luiz', 'Initials': 'JL', 'LastName': 'Miraglia', 'Affiliation': 'Division of Clinical Trials and Pharmacovigilance, Instituto Butantan, São Paulo, Brazil.'}, {'ForeName': 'Neuza M F', 'Initials': 'NMF', 'LastName': 'Gallina', 'Affiliation': 'Division of Clinical Trials and Pharmacovigilance, Instituto Butantan, São Paulo, Brazil.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Weiskopf', 'Affiliation': 'Division of Vaccine Discovery, La Jolla Institute for Allergy and Immunology, San Diego, CA, USA.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Sette', 'Affiliation': 'Division of Vaccine Discovery, La Jolla Institute for Allergy and Immunology, San Diego, CA, USA.'}, {'ForeName': 'Raphaella', 'Initials': 'R', 'LastName': 'Goulart', 'Affiliation': 'Division of Clinical Immunology and Allergy, School of Medicine, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Rafael Tavares', 'Initials': 'RT', 'LastName': 'Salles', 'Affiliation': 'Division of Clinical Immunology and Allergy, School of Medicine, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Alvino', 'Initials': 'A', 'LastName': 'Maestri', 'Affiliation': 'Division of Clinical Immunology and Allergy, School of Medicine, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Adriana Maluf Elias', 'Initials': 'AME', 'LastName': 'Sallum', 'Affiliation': 'Department of Pediatrics, School of Medicine, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Sylvia Costa Lima', 'Initials': 'SCL', 'LastName': 'Farhat', 'Affiliation': 'Department of Pediatrics, School of Medicine, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Neusa K', 'Initials': 'NK', 'LastName': 'Sakita', 'Affiliation': 'Department of Pediatrics, School of Medicine, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Juliana C O A', 'Initials': 'JCOA', 'LastName': 'Ferreira', 'Affiliation': 'Department of Pediatrics, School of Medicine, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Cassia G T', 'Initials': 'CGT', 'LastName': 'Silveira', 'Affiliation': 'Division of Clinical Immunology and Allergy, School of Medicine, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Priscilla R', 'Initials': 'PR', 'LastName': 'Costa', 'Affiliation': 'Division of Clinical Immunology and Allergy, School of Medicine, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Isaias', 'Initials': 'I', 'LastName': 'Raw', 'Affiliation': 'Division of Clinical Trials and Pharmacovigilance, Instituto Butantan, São Paulo, Brazil.'}, {'ForeName': 'Stephen S', 'Initials': 'SS', 'LastName': 'Whitehead', 'Affiliation': 'Laboratory of Viral Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Anna P', 'Initials': 'AP', 'LastName': 'Durbin', 'Affiliation': 'Center for Immunization Research, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Kalil', 'Affiliation': 'Division of Clinical Immunology and Allergy, School of Medicine, University of São Paulo, São Paulo, Brazil.'}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(20)30023-2'] 487,31311674,"Efficacy, safety, and tolerability of rimegepant orally disintegrating tablet for the acute treatment of migraine: a randomised, phase 3, double-blind, placebo-controlled trial.","BACKGROUND Rimegepant, a small molecule calcitonin gene-related peptide receptor antagonist, has shown efficacy in the acute treatment of migraine using a standard tablet formulation. The objective of this trial was to compare the efficacy, safety, and tolerability of a novel orally disintegrating tablet formulation of rimegepant at 75 mg with placebo in the acute treatment of migraine. METHODS In this double-blind, randomised, placebo-controlled, multicentre phase 3 trial, adults aged 18 years or older with history of migraine of at least 1 year were recruited to 69 study centres in the USA. Participants were randomly assigned to receive rimegepant (75 mg orally disintegrating tablet) or placebo and instructed to treat a single migraine attack of moderate or severe pain intensity. The randomisation was stratified by the use of prophylactic medication (yes or no), and was carried out using an interactive web response system that was accessed by each clinical site. All participants, investigators, and the sponsor were masked to treatment group assignment. The coprimary endpoints were freedom from pain and freedom from the most bothersome symptom at 2 h postdose. The efficacy analyses used the modified intention-to-treat population, which included all patients who were randomly assigned, had a migraine attack with pain of moderate or severe intensity, took a dose of rimegepant or placebo, and had at least one efficacy assessment after administration of the dose. The safety analyses included all randomly assigned participants who received at least one dose of study medication. This study is registered with ClinicalTrials.gov, number NCT03461757, and is closed to accrual. FINDINGS Between Feb 27 and Aug 28, 2018, 1811 participants were recruited and assessed for eligibility. 1466 participants were randomly assigned to the rimegepant (n=732) or placebo (n=734) groups, of whom 1375 received treatment with rimegepant (n=682) or placebo (n=693), and 1351 were evaluated for efficacy (rimegepant n=669, placebo n=682). At 2 h postdose, rimegepant orally disintegrating tablet was superior to placebo for freedom from pain (21% vs 11%, p<0·0001; risk difference 10, 95% CI 6-14) and freedom from the most bothersome symptom (35% vs 27%, p=0·0009; risk difference 8, 95% CI 3-13). The most common adverse events were nausea (rimegepant n=11 [2%]; placebo n=3 [<1%]) and urinary tract infection (rimegepant n=10 [1%]; placebo n=4 [1%]). One participant in each treatment group had a transaminase concentration of more than 3 × the upper limit of normal; neither was related to study medication, and no elevations in bilirubin greater than 2 × the upper limit of normal were reported. Treated participants reported no serious adverse events. INTERPRETATION In the acute treatment of migraine, a single 75 mg dose of rimegepant in an orally disintegrating tablet formulation was more effective than placebo. Tolerability was similar to placebo, with no safety concerns. FUNDING Biohaven Pharmaceuticals.",2019,"At 2 h postdose, rimegepant orally disintegrating tablet was superior to placebo for freedom from pain (21% vs 11%, p<0·0001; risk difference 10, 95% CI 6-14) and freedom from the most bothersome symptom (35% vs 27%, p=0·0009; risk difference 8, 95% CI 3-13).","['n=734) groups, of whom 1375 received treatment with rimegepant (n=682) or', 'Between Feb 27 and Aug 28, 2018, 1811 participants were recruited and assessed for eligibility', '1466 participants', 'migraine', 'patients who were randomly assigned, had a migraine attack with pain of moderate or severe intensity, took a dose of rimegepant or placebo, and had at least one efficacy assessment after administration of the dose', 'adults aged 18 years or older with history of migraine of at least 1 year were recruited to 69 study centres in the USA']","['rimegepant orally disintegrating tablet', 'rimegepant (75 mg orally disintegrating tablet) or placebo', 'placebo']","['serious adverse events', 'efficacy, safety, and tolerability', 'Efficacy, safety, and tolerability', 'bothersome symptom', 'freedom from pain and freedom from the most bothersome symptom at 2 h postdose', 'urinary tract infection', 'transaminase concentration', 'Tolerability', 'nausea']","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0149931', 'cui_str': 'Migraine Disorders'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C1304680', 'cui_str': 'Attack (finding)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0455512', 'cui_str': 'H/O: migraine'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]","[{'cui': 'C1705223', 'cui_str': 'Tablet'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0011744', 'cui_str': 'Hydrogen-2'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease (disorder)'}, {'cui': 'C0002594', 'cui_str': 'Aminotransferases'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}]",1466.0,0.722446,"At 2 h postdose, rimegepant orally disintegrating tablet was superior to placebo for freedom from pain (21% vs 11%, p<0·0001; risk difference 10, 95% CI 6-14) and freedom from the most bothersome symptom (35% vs 27%, p=0·0009; risk difference 8, 95% CI 3-13).","[{'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Croop', 'Affiliation': 'Biohaven Pharmaceuticals, New Haven, CT, USA. Electronic address: robert.croop@biohavenpharma.com.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Goadsby', 'Affiliation': ""NIHR-Wellcome Trust King's Clinical Research Facility, King's College Hospital/SLaM Biomedical Research Centre, King's College London, UK; Department of Neurology, University of California, San Francisco, San Francisco, CA, USA.""}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Stock', 'Affiliation': 'Biohaven Pharmaceuticals, New Haven, CT, USA.'}, {'ForeName': 'Charles M', 'Initials': 'CM', 'LastName': 'Conway', 'Affiliation': 'Biohaven Pharmaceuticals, New Haven, CT, USA.'}, {'ForeName': 'Micaela', 'Initials': 'M', 'LastName': 'Forshaw', 'Affiliation': 'Biohaven Pharmaceuticals, New Haven, CT, USA.'}, {'ForeName': 'Elyse G', 'Initials': 'EG', 'LastName': 'Stock', 'Affiliation': 'Biohaven Pharmaceuticals, New Haven, CT, USA.'}, {'ForeName': 'Vladimir', 'Initials': 'V', 'LastName': 'Coric', 'Affiliation': 'Biohaven Pharmaceuticals, New Haven, CT, USA.'}, {'ForeName': 'Richard B', 'Initials': 'RB', 'LastName': 'Lipton', 'Affiliation': 'Department of Neurology, Albert Einstein College of Medicine, Bronx, NY, USA.'}]","Lancet (London, England)",['10.1016/S0140-6736(19)31606-X'] 488,29444275,"E-cigarette Advertising Exposure, Explicit and Implicit Harm Perceptions, and E-cigarette Use Susceptibility Among Nonsmoking Young Adults.","Introduction This study tested whether exposure to e-cigarette advertising increases e-cigarette use susceptibility among nonsmoking young adults by promoting explicit and implicit attitudes toward e-cigarettes as a safer and healthier alternative to combustible cigarettes. Methods Young adult current nonsmokers who had never used an e-cigarette (n = 393; mean age = 22.1, standard deviation = 3.9; 66% women) were randomly assigned to one of the three conditions that involved viewing real-world, print e-cigarette ads. Two of the three conditions were experimental conditions where ads with different predominant themes (harm reduction [""Health""] versus social enhancement [""Social""] focused) were interspersed among ads of everyday objects. The third condition was the Control condition involving ads of everyday objects only. Participants provided data on explicit (ie, self-reported harm perceptions) and implicit (ie, Implicit Association Test) attitudes toward e-cigarette use and e-cigarette use intentions. Hypotheses were tested using structural equation modeling. Results Relative to Control participants, participants in Health and Social conditions were more likely to show higher implicit attitudes toward e-cigarettes as a safer alternative to cigarettes. Only the Social condition, relative to Control, had a significant effect on lower explicit harm perceptions of e-cigarette versus cigarette use. The Social condition had a significant indirect effect on e-cigarette use susceptibility, mediated by explicit harm perceptions. Conclusions Social enhancement-themed ads may communicate the reduced harm messages more strongly among young adults so as to affect both explicit and implicit attitudes and, through these, e-cigarette use susceptibility. Regulatory bodies may need to scrutinize reduced harm claims communicated through social enhancement-themed ads. Implications The findings imply that implicit and explicit health benefit or reduced harm claims in e-cigarette marketing may be propagated via ads that use social enhancement gimmicks to attract youth and young adults. As the US Food and Drug Administration develops regulations on e-cigarette marketing, informed decisions need to be made that address harm reduction needs of current smokers as well as e-cigarette use onset among nonsmokers. In regard to the latter, e-cigarette marketing may need to be studied closely to monitor implicit and explicit health benefit claims that are coupled with the use of visual and textual gimmicks in ads that intend to make e-cigarettes more appealing to youth and young adults.",2019,"Relative to Control participants, participants in Health and Social conditions were more likely to show higher implicit attitudes toward e-cigarettes as a safer alternative to cigarettes.","['Young adult current nonsmokers who had never used an e-cigarette (n = 393; mean age = 22.1, standard deviation = 3.9; 66% women', 'Nonsmoking Young Adults', 'nonsmoking young adults']",[],"['data on explicit (ie, self-reported harm perceptions) and implicit (ie, Implicit Association Test) attitudes toward e-cigarette use and e-cigarette use intentions']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C4554605', 'cui_str': 'Nonsmokers'}, {'cui': 'C3849993', 'cui_str': 'Electronic Cigarettes'}, {'cui': 'C4517754', 'cui_str': 'Three hundred and ninety-three'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C4517698', 'cui_str': '3.9 (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]",[],"[{'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C4280017', 'cui_str': 'E-Cig Use'}, {'cui': 'C0162425', 'cui_str': 'Intention'}]",393.0,0.0117607,"Relative to Control participants, participants in Health and Social conditions were more likely to show higher implicit attitudes toward e-cigarettes as a safer alternative to cigarettes.","[{'ForeName': 'Pallav', 'Initials': 'P', 'LastName': 'Pokhrel', 'Affiliation': 'Cancer Prevention in Pacific Program, University of Hawaii Cancer Center, University of Hawaii at Manoa, Honolulu, HI.'}, {'ForeName': 'Thaddeus A', 'Initials': 'TA', 'LastName': 'Herzog', 'Affiliation': 'Cancer Prevention in Pacific Program, University of Hawaii Cancer Center, University of Hawaii at Manoa, Honolulu, HI.'}, {'ForeName': 'Pebbles', 'Initials': 'P', 'LastName': 'Fagan', 'Affiliation': 'Center for the Study of Tobacco, Department of Health Behavior and Health Education, Fay W. Boozman College of Public Health, University of Arkansas for Medical Sciences, Little Rock, AR.'}, {'ForeName': 'Jennifer B', 'Initials': 'JB', 'LastName': 'Unger', 'Affiliation': 'Department of Preventive Medicine, University of Southern California, Los Angeles, CA.'}, {'ForeName': 'Alan W', 'Initials': 'AW', 'LastName': 'Stacy', 'Affiliation': 'School of Community and Global Health, Claremont Graduate University, Claremont, CA.'}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/nty030'] 489,30985449,The Restrictive IV Fluid Trial in Severe Sepsis and Septic Shock (RIFTS): A Randomized Pilot Study.,"OBJECTIVES It is unclear if a low- or high-volume IV fluid resuscitation strategy is better for patients with severe sepsis and septic shock. DESIGN Prospective randomized controlled trial. SETTING Two adult acute care hospitals within a single academic system. PATIENTS Patients with severe sepsis and septic shock admitted from the emergency department to the ICU from November 2016 to February 2018. INTERVENTIONS Patients were randomly assigned to a restrictive IV fluid resuscitation strategy (≤ 60 mL/kg of IV fluid) or usual care for the first 72 hours of care. MEASUREMENTS AND MAIN RESULTS We enrolled 109 patients, of whom 55 were assigned to the restrictive resuscitation group and 54 to the usual care group. The restrictive group received significantly less resuscitative IV fluid than the usual care group (47.1 vs 61.1 mL/kg; p = 0.01) over 72 hours. By 30 days, there were 12 deaths (21.8%) in the restrictive group and 12 deaths (22.2%) in the usual care group (odds ratio, 1.02; 95% CI, 0.41-2.53). There were no differences between groups in the rate of new organ failure, hospital or ICU length of stay, or serious adverse events. CONCLUSIONS This pilot study demonstrates that a restrictive resuscitation strategy can successfully reduce the amount of IV fluid administered to patients with severe sepsis and septic shock compared with usual care. Although limited by the sample size, we observed no increase in mortality, organ failure, or adverse events. These findings further support that a restrictive IV fluid strategy should be explored in a larger multicenter trial.",2019,"There were no differences between groups in the rate of new organ failure, hospital or ICU length of stay, or serious adverse events. ","['109 patients, of whom 55 were assigned to the restrictive resuscitation group and 54 to the usual care group', 'Two adult acute care hospitals within a single academic system', 'Severe Sepsis and Septic Shock (RIFTS', 'patients with severe sepsis and septic shock compared with usual care', 'patients with severe sepsis and septic shock', 'Patients with severe sepsis and septic shock admitted from the emergency department to the ICU from November 2016 to February 2018']",['restrictive IV fluid resuscitation strategy (≤ 60\u2009mL/kg of IV fluid) or usual care for the first 72 hours of care'],"['rate of new organ failure, hospital or ICU length of stay, or serious adverse events', 'resuscitative IV fluid', 'mortality, organ failure, or adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0035273', 'cui_str': 'Resuscitation'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C3661916', 'cui_str': 'Acute care hospital'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C1719672', 'cui_str': 'Severe Sepsis'}, {'cui': 'C0036983', 'cui_str': 'Septic Shock'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}]","[{'cui': 'C1289919', 'cui_str': 'Intravenous fluid'}, {'cui': 'C0035273', 'cui_str': 'Resuscitation'}, {'cui': 'C1300574', 'cui_str': 'microliter/g'}, {'cui': 'C1292423', 'cui_str': '72 hours (qualifier value)'}]","[{'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0349410', 'cui_str': 'Single organ dysfunction (disorder)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1289919', 'cui_str': 'Intravenous fluid'}, {'cui': 'C0026566', 'cui_str': 'mortality'}]",109.0,0.17073,"There were no differences between groups in the rate of new organ failure, hospital or ICU length of stay, or serious adverse events. ","[{'ForeName': 'Keith A', 'Initials': 'KA', 'LastName': 'Corl', 'Affiliation': 'Department of Medicine, Division of Pulmonary Critical Care and Sleep, Alpert Medical School of Brown University, Providence, RI.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Prodromou', 'Affiliation': 'Department of Medicine, Division of Pulmonary Critical Care and Sleep, Alpert Medical School of Brown University, Providence, RI.'}, {'ForeName': 'Roland C', 'Initials': 'RC', 'LastName': 'Merchant', 'Affiliation': 'Brown School of Public Health, Providence, RI.'}, {'ForeName': 'Ilana', 'Initials': 'I', 'LastName': 'Gareen', 'Affiliation': 'Brown School of Public Health, Providence, RI.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Marks', 'Affiliation': ""Department of Emergency Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA.""}, {'ForeName': 'Debasree', 'Initials': 'D', 'LastName': 'Banerjee', 'Affiliation': 'Department of Medicine, Division of Pulmonary Critical Care and Sleep, Alpert Medical School of Brown University, Providence, RI.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Amass', 'Affiliation': 'Department of Medicine, Division of Pulmonary Critical Care and Sleep, Alpert Medical School of Brown University, Providence, RI.'}, {'ForeName': 'Adeel', 'Initials': 'A', 'LastName': 'Abbasi', 'Affiliation': 'Department of Medicine, Division of Pulmonary Critical Care and Sleep, Alpert Medical School of Brown University, Providence, RI.'}, {'ForeName': 'Cesar', 'Initials': 'C', 'LastName': 'Delcompare', 'Affiliation': 'Department of Medicine, Division of Pulmonary Critical Care and Sleep, Alpert Medical School of Brown University, Providence, RI.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Palmisciano', 'Affiliation': 'Department of Medicine, Division of Pulmonary Critical Care and Sleep, Alpert Medical School of Brown University, Providence, RI.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Aliotta', 'Affiliation': 'Department of Medicine, Division of Pulmonary Critical Care and Sleep, Alpert Medical School of Brown University, Providence, RI.'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Jay', 'Affiliation': 'Department of Emergency Medicine, Alpert Medical School of Brown University, Providence, RI.'}, {'ForeName': 'Mitchell M', 'Initials': 'MM', 'LastName': 'Levy', 'Affiliation': 'Department of Medicine, Division of Pulmonary Critical Care and Sleep, Alpert Medical School of Brown University, Providence, RI.'}]",Critical care medicine,['10.1097/CCM.0000000000003779'] 490,31935353,Effects of Geriatric Interdisciplinary Home Rehabilitation on Independence in Activities of Daily Living in Older People With Hip Fracture: A Randomized Controlled Trial.,"OBJECTIVE To evaluate the effects of early discharge followed by geriatric interdisciplinary home rehabilitation for older people with hip fracture on independence in activities of daily living (ADL) compared with inhospital geriatric care according to a multifactorial rehabilitation program. DESIGN Planned analysis of a randomized controlled trial with 3- and 12-month follow-ups. SETTING Geriatric ward, ordinary housing, and residential care facilities. PARTICIPANTS Of 466 people screened for eligibility, participants (N=205) with acute hip fracture, aged 70 years or older, including those with cognitive impairment and those living in residential care facilities, were randomized to intervention or control groups. INTERVENTION Individually designed interdisciplinary home rehabilitation for a maximum of 10 weeks. The intervention aimed at early hospital discharge and focused on prevention of falls, independence in daily activities, and walking ability indoors and outdoors. MAIN OUTCOME MEASURES Independence in ADL was measured using the Barthel ADL Index, and the ADL Staircase including the Katz ADL Index during hospital stay (prefracture performance) and at the follow-up visits in the participants' homes. RESULTS There were no significant differences in ADL performance between the groups, and they recovered their prefracture level of independence in personal and instrumental ADL comparably. At 12 months, 33 (41.3%) in the intervention group vs 33 (41.8%) in the control group (P=.99) had regained or improved their prefracture ADL performance according to the Barthel ADL Index, and 27 (37.0%) vs 36 (48.6%) according to the ADL Staircase (P=.207). CONCLUSIONS In older people with hip fracture, early discharge followed by geriatric interdisciplinary home rehabilitation resulted in a comparable recovery of independence in ADL at 3 and 12 months as inhospital geriatric care and rehabilitation.",2020,"There were no significant differences in ADL performance between the groups, and they recovered their pre-fracture level of independence in personal and instrumental ADLs comparably.","['older people with hip fracture, early discharge followed by geriatric interdisciplinary home rehabilitation', 'Of 466 people screened for eligibility, 205 participants with acute hip fracture, aged 70 or older, including those with cognitive impairment, and those living in residential care facilities', 'older people with hip fracture on independence in Activities of Daily Living (ADLs) compared with in-hospital geriatric care according to a multifactorial rehabilitation program', 'Older People with Hip Fracture', 'Geriatric ward, ordinary housing and residential care facilities', ""participants' homes""]","['geriatric interdisciplinary home rehabilitation', 'Geriatric Interdisciplinary Home Rehabilitation']","['ADL performance', 'pre-fracture ADL performance', 'Independence in Activities of Daily Living']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0019557', 'cui_str': 'Hip Fractures'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0017469', 'cui_str': 'Geriatrics'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0338656', 'cui_str': 'Cognitive Dysfunction'}, {'cui': 'C0001288', 'cui_str': 'ADL'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C1305702', 'cui_str': 'Ward (environment)'}, {'cui': 'C0020056', 'cui_str': 'Housing'}]","[{'cui': 'C0017469', 'cui_str': 'Geriatrics'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}]","[{'cui': 'C0001288', 'cui_str': 'ADL'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}]",205.0,0.126941,"There were no significant differences in ADL performance between the groups, and they recovered their pre-fracture level of independence in personal and instrumental ADLs comparably.","[{'ForeName': 'Åsa', 'Initials': 'Å', 'LastName': 'Karlsson', 'Affiliation': 'Department of Community Medicine and Rehabilitation, Geriatric Medicine, Umeå University, Umeå, Sweden; Department of Community Medicine and Rehabilitation, Physiotherapy, Umeå University, Umeå, Sweden. Electronic address: asa.karlsson@umu.se.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Lindelöf', 'Affiliation': 'Department of Community Medicine and Rehabilitation, Geriatric Medicine, Umeå University, Umeå, Sweden; Department of Community Medicine and Rehabilitation, Physiotherapy, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Birgitta', 'Initials': 'B', 'LastName': 'Olofsson', 'Affiliation': 'Department of Nursing, Umeå University, Umeå, Sweden; Department of Surgical and Perioperative Science, Orthopedics, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Berggren', 'Affiliation': 'Department of Community Medicine and Rehabilitation, Geriatric Medicine, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Yngve', 'Initials': 'Y', 'LastName': 'Gustafson', 'Affiliation': 'Department of Community Medicine and Rehabilitation, Geriatric Medicine, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Nordström', 'Affiliation': 'Department of Community Medicine and Rehabilitation, Geriatric Medicine, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Stenvall', 'Affiliation': 'Department of Community Medicine and Rehabilitation, Geriatric Medicine, Umeå University, Umeå, Sweden.'}]",Archives of physical medicine and rehabilitation,['10.1016/j.apmr.2019.12.007'] 491,31370751,Comparison of epidural anesthesia with chloroprocaine and lidocaine for outpatient knee arthroscopy.,"This study aimed to compare clinical efficacy and safety of chloroprocaine and lidocaine in epidural anesthesia for outpatient knee arthroscopy. Eighty patients undergoing knee arthroscopy were randomly allocated to receive 3% 2-chloroprocaine (group C, n = 40) or 2% lidocaine (group L, n = 40) for epidural block. Latency to anesthesia onset, highest block level, time to achieve peak effect, time to complete sensory and motor block regression, vital signs including respiration and hemodynamics, and complications during follow-up were recorded. No significant differences were found in the latency to anesthesia onset and peak effect, duration of anesthesia efficacy, and the time for recovery of sensory function between the two groups. However, the latency to maximal block of pain sensation and the time needed to recover motor function were significantly shorter in group C than in group L ( p < 0.05). No adverse effects or neurologic complications were found in both groups. In conclusion, epidural chloroprocaine elicits rapid anesthetic effects, fast sensor and motor block, and faster recovery of motor function compared to lidocaine. These characteristics make chloroprocaine better than lidocaine as the choice of epidural anesthesia in short clinical operations such as knee arthroscopy.",2019,No adverse effects or neurologic complications were found in both groups.,"['outpatient knee arthroscopy', 'Eighty patients undergoing knee arthroscopy']","['chloroprocaine and lidocaine', 'epidural anesthesia with chloroprocaine and lidocaine', '2-chloroprocaine', 'epidural chloroprocaine', 'lidocaine', 'chloroprocaine']","['Latency to anesthesia onset, highest block level, time to achieve peak effect, time to complete sensory and motor block regression, vital signs including respiration and hemodynamics, and complications', 'anesthetic effects, fast sensor and motor block, and faster recovery of motor function', 'latency to anesthesia onset and peak effect, duration of anesthesia efficacy, and the time for recovery of sensory function', 'clinical efficacy and safety', 'adverse effects or neurologic complications', 'latency to maximal block of pain sensation and the time needed to recover motor function']","[{'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0187970', 'cui_str': 'Diagnostic arthroscopy of knee'}, {'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0055443', 'cui_str': 'chloroprocaine'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0002913', 'cui_str': 'Anesthesia, Extradural'}]","[{'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0445254', 'cui_str': 'Sensory (qualifier value)'}, {'cui': 'C0684321', 'cui_str': 'Regression'}, {'cui': 'C0518766'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0035203', 'cui_str': 'Breathing'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C3179301', 'cui_str': 'Anesthetic Effect'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0234130', 'cui_str': 'Motor function (observable entity)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0036658', 'cui_str': 'Sensory Function'}, {'cui': 'C0087113', 'cui_str': 'Treatment Efficacy'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0205494', 'cui_str': 'Neurologic (qualifier value)'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0027552', 'cui_str': 'Needs'}]",80.0,0.0365734,No adverse effects or neurologic complications were found in both groups.,"[{'ForeName': 'Zhengchao', 'Initials': 'Z', 'LastName': 'Yang', 'Affiliation': '1 Department of Anesthesiology, Wuhan No. 1 Hospital, Wuhan, Hubei, China.'}, {'ForeName': 'Dezhan', 'Initials': 'D', 'LastName': 'Li', 'Affiliation': '2 Department of Anesthesiology, Jingzhou Central Hospital, The Second Clinical Medical College, Yangtze University, Jingzhou, Hubei, China.'}, {'ForeName': 'Kun', 'Initials': 'K', 'LastName': 'Zhang', 'Affiliation': '2 Department of Anesthesiology, Jingzhou Central Hospital, The Second Clinical Medical College, Yangtze University, Jingzhou, Hubei, China.'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Yang', 'Affiliation': '3 Department of Clinical Oncology, Taihe Hospital, Hubei University of Medicine, Shiyan, Hubei, China.'}, {'ForeName': 'Man', 'Initials': 'M', 'LastName': 'Li', 'Affiliation': '4 Department of Oncology, Jingzhou Central Hospital, The Second Clinical Medical College, Yangtze University, Jingzhou, Hubei, China.'}, {'ForeName': 'Lishen', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': '2 Department of Anesthesiology, Jingzhou Central Hospital, The Second Clinical Medical College, Yangtze University, Jingzhou, Hubei, China.'}]",Journal of orthopaedic surgery (Hong Kong),['10.1177/2309499019865534'] 492,31382815,Clinical research about the improved PVP method in treatment of acute osteoporotic vertebral compression fractures.,"OBJECTIVE The traditional percutaneous vertebroplasty (PVP) could induce massive radiation and side injuries to the tissues around the fractured centrum. This study was designed to reduce the radiation and damage and improve the treatment efficiency of PVP. METHODS Forty four patients who diagnosed to be acute osteoporotic single vertebral compression fractures were collected and randomly divided into traditional group and improved group, and these two groups were separately treated by the traditional and improved PVP which assisted by the preoperative digital design. The treatment outcome between these two groups was compared and analyzed by Students' t test and χ 2 test. RESULTS Compared with the traditional PVP, the improved PVP could significantly reduce the X-ray fluoroscopy times for determining puncture point (14.41 ± 4.00 vs. 6.82 ± 2.15, p < 0.001) and puncture route (22.73 ± 3.89 vs. 13.36 ± 3.39, p < 0.001), the X-ray fluoroscopy times during the operation (76.59 ± 12.4 vs. 34.82 ± 6.74, p < 0.001), operation duration (28.64 ± 7.43 min vs. 15.23 ± 4.4 min, p < 0.001), and total radiological dose (588.85 ± 53.86 cGycm 2 vs. 276.5 ± 58.17 cGycm 2 , p < 0.001). The improved PVP could also significantly decrease the visual analog score at intra-operation (7.68 ± 0.78 vs. 4.50 ± 0.67, p < 0.001) and 1 day after the operation (2.45 ± 0.51 vs. 2.16 ± 0.36, p < 0.05). Besides, the improved PVP could not significantly affect the Oswestry disability index after operation ( p > 0.05). CONCLUSION The improved PVP operation could significantly reduce the total radiological dose and X-ray fluoroscopy times, protect the patients and medical staff, and reduce the pain caused by the operation. TRIAL REGISTRATION This trial was registered in China clinical trial registration center and the registration number was ChiCTR-INR-17011557.",2019,"The improved PVP operation could significantly reduce the total radiological dose and X-ray fluoroscopy times, protect the patients and medical staff, and reduce the pain caused by the operation. ","['Forty four patients who diagnosed to be acute osteoporotic single vertebral compression fractures', 'acute osteoporotic vertebral compression fractures']",['traditional percutaneous vertebroplasty (PVP'],"['operation duration', 'pain', 'total radiological dose and X-ray fluoroscopy times', 'visual analog score', 'Oswestry disability index', 'total radiological dose']","[{'cui': 'C4319568', 'cui_str': '44'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0521169', 'cui_str': 'Compression fracture (morphologic abnormality)'}]","[{'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach - access (qualifier value)'}, {'cui': 'C1303192', 'cui_str': 'Vertebroplasty'}]","[{'cui': 'C0038895', 'cui_str': 'operative therapy'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0034571', 'cui_str': 'radiography'}, {'cui': 'C0016356', 'cui_str': 'Fluoroscopy'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index (assessment scale)'}]",44.0,0.0186586,"The improved PVP operation could significantly reduce the total radiological dose and X-ray fluoroscopy times, protect the patients and medical staff, and reduce the pain caused by the operation. ","[{'ForeName': 'Yao', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Spine Surgery Department, Beijing ShiJiTan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'JiPeng', 'Initials': 'J', 'LastName': 'Song', 'Affiliation': 'Spine Surgery Department, Beijing ShiJiTan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Hou', 'Affiliation': 'Spine Surgery Department, Beijing ShiJiTan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'GenAi', 'Initials': 'G', 'LastName': 'Zhang', 'Affiliation': 'Spine Surgery Department, Beijing ShiJiTan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'LiXiang', 'Initials': 'L', 'LastName': 'Ding', 'Affiliation': 'Spine Surgery Department, Beijing ShiJiTan Hospital, Capital Medical University, Beijing, China.'}]",Journal of orthopaedic surgery (Hong Kong),['10.1177/2309499019864667'] 493,31926142,Acute Hemodynamic Effects of Virtual Reality-Based Therapy in Patients of Cardiovascular Rehabilitation: A Cluster Randomized Crossover Trial.,"OBJECTIVE To analyze the acute hemodynamic effects of adding virtual reality-based therapy (VRBT) using exergames for patients undergoing cardiac rehabilitation (CR). DESIGN Crossover trial. SETTING Outpatient rehabilitation center. PARTICIPANTS Patients (N=27) with a diagnosis of cardiovascular disease or cardiovascular risk factors. Mean age (years) ± SD was 63.4±12.7 and mean body mass index (kg/m2) ± SD was 29.0±4.0. INTERVENTIONS Patients performed 1 VRBT session and 1 CR session on 2 nonconsecutive days. Each session comprised an initial rest, warm-up, conditioning, and recovery. During warm-up, in the VRBT session, games were performed with sensors to reproduce the movements of avatars and, in the CR session, patients were required to reproduce the movements of the physiotherapists. In the conditioning phase for VRBT, games were also played with motion sensors, dumbbells, and shin guards. The CR session consisted of exercises performed on a treadmill. The intensity of training was prescribed by heart rate reserve (HRR; 40%-70%). MAIN OUTCOME MEASURES The primary outcomes were heart rate, blood pressure, respiratory rate (RR), rating of perceived exertion (RPE), and peripheral oxygen saturation, evaluated before, during, and after the VRBT or CR session on 2 nonconsecutive days. The secondary outcome was to evaluate whether the patients achieved the prescribed HRR and the percentage of time they maintained this level during the VRBT session. RESULTS VRBT produces a physiological similar pattern of acute hemodynamic effects in CR. However, there was greater magnitude of heart rate, RR, and RPE (P<.01) during the execution of VRBT and until 5 minutes of recovery, observed at the moments of rest, and 1, 3, and 5 minutes of recovery. CONCLUSIONS Although the VRBT session produces similar physiological acute hemodynamic effects in CR, greater magnitudes of heart rate, RR, and RPE were observed during its execution and up to 5 minutes after the session.",2020,"However, there was greater magnitude of HR, RR, and RPE (p<0.01) during the execution of VRBT and until 5 minutes of recovery, observed at the moments of rest, and the 1st, 3rd, and 5th minutes of recovery. ","['patients of cardiovascular rehabilitation', 'outpatient rehabilitation center', 'patients (n=27, 63.4±12.7y, 29.0±4.0kg/m2) with a diagnosis of cardiovascular disease or cardiovascular risk factors', 'cardiac patients undergoing CR']","['VRBT session and one CR session', 'virtual reality based-therapy', 'VRBT', 'VRBT session']","['prescribed HRR and the percentage of time they maintained this level during the VRBT session', 'heart rate (HR), blood pressure, respiratory rate (RR), rating of perceived exertion (RPE), and peripheral oxygen saturation, evaluated before, during, and after the VRBT or CR session', 'magnitude of HR, RR, and RPE (p<0.01', 'magnitudes of HR, RR, and RPE']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0700431', 'cui_str': 'Cardiovascular Rehabilitation'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0034993', 'cui_str': 'Rehabilitation Centers'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}]","[{'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0347984', 'cui_str': 'During (attribute)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0231832', 'cui_str': 'Respiration Rate'}, {'cui': 'C0015264', 'cui_str': 'Exertion, function (observable entity)'}, {'cui': 'C2317096', 'cui_str': 'Peripheral oxygen saturation'}, {'cui': 'C1704240', 'cui_str': 'Magnitudes (qualifier value)'}, {'cui': 'C0445208', 'cui_str': 'RPE'}]",,0.0844307,"However, there was greater magnitude of HR, RR, and RPE (p<0.01) during the execution of VRBT and until 5 minutes of recovery, observed at the moments of rest, and the 1st, 3rd, and 5th minutes of recovery. ","[{'ForeName': 'Mayara Moura', 'Initials': 'MM', 'LastName': 'Alves da Cruz', 'Affiliation': 'Department of Physiotherapy, São Paulo State University, School of Technology and Sciences, Presidente Prudente, Brazil. Electronic address: maya_bilac@hotmail.com.'}, {'ForeName': 'Ana Laura', 'Initials': 'AL', 'LastName': 'Ricci-Vitor', 'Affiliation': 'Department of Physiotherapy, São Paulo State University, School of Technology and Sciences, Presidente Prudente, Brazil.'}, {'ForeName': 'Giovanna Lombardi', 'Initials': 'GL', 'LastName': 'Bonini Borges', 'Affiliation': 'Department of Physiotherapy, São Paulo State University, School of Technology and Sciences, Presidente Prudente, Brazil.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Fernanda da Silva', 'Affiliation': 'Department of Physiotherapy, São Paulo State University, School of Technology and Sciences, Presidente Prudente, Brazil.'}, {'ForeName': 'Felipe', 'Initials': 'F', 'LastName': 'Ribeiro', 'Affiliation': 'Department of Physiotherapy, São Paulo State University, School of Technology and Sciences, Presidente Prudente, Brazil.'}, {'ForeName': 'Luiz Carlos', 'Initials': 'LC', 'LastName': 'Marques Vanderlei', 'Affiliation': 'Department of Physiotherapy, São Paulo State University, School of Technology and Sciences, Presidente Prudente, Brazil.'}]",Archives of physical medicine and rehabilitation,['10.1016/j.apmr.2019.12.006'] 494,32221582,Effects of dapagliflozin in DAPA-HF according to background heart failure therapy.,"AIMS In the DAPA-HF trial, the SGLT2 inhibitor dapagliflozin reduced the risk of worsening heart failure (HF) and death in patients with HF and reduced ejection fraction. We examined whether this benefit was consistent in relation to background HF therapy. METHODS AND RESULTS In this post hoc analysis, we examined the effect of study treatment in the following yes/no subgroups: diuretic, digoxin, mineralocorticoid receptor antagonist (MRA), sacubitril/valsartan, ivabradine, implanted cardioverter-defibrillating (ICD) device, and cardiac resynchronization therapy. We also examined the effect of study drug according to angiotensin-converting enzyme inhibitor/angiotensin receptor blocker dose, beta-blocker (BB) dose, and MRA (≥50% and <50% of target dose). We analysed the primary composite endpoint of cardiovascular death or a worsening HF event. Most randomized patients (n = 4744) were treated with a diuretic (84%), renin-angiotensin system (RAS) blocker (94%), and BB (96%); 52% of those taking a BB and 38% taking a RAS blocker were treated with ≥50% of the recommended dose. Overall, the dapagliflozin vs. placebo hazard ratio (HR) was 0.74 [95% confidence interval (CI) 0.65-0.85] for the primary composite endpoint (P < 0.0001). The effect of dapagliflozin was consistent across all subgroups examined: the HR ranged from 0.57 to 0.86 for primary endpoint, with no significant randomized treatment-by-subgroup interaction. For example, the HR in patients taking a RAS blocker, BB, and MRA at baseline was 0.72 (95% CI 0.61-0.86) compared with 0.77 (95% CI 0.63-0.94) in those not on all three of these treatments (P-interaction 0.64). CONCLUSION The benefit of dapagliflozin was consistent regardless of background therapy for HF.",2020,"Overall, the dapagliflozin vs. placebo hazard ratio (HR) was 0.74 [95% confidence interval (CI) 0.65-0.85] for the primary composite endpoint (P < 0.0001).",[],"['angiotensin-converting enzyme inhibitor/angiotensin receptor blocker dose, beta-blocker (BB', 'dapagliflozin vs. placebo', 'diuretic', 'renin-angiotensin system', 'diuretic, digoxin, mineralocorticoid receptor antagonist (MRA), sacubitril/valsartan, ivabradine, implanted cardioverter-defibrillating (ICD) device, and cardiac resynchronization therapy', 'SGLT2 inhibitor dapagliflozin', 'dapagliflozin']","['risk of worsening heart failure (HF) and death', 'cardiovascular death or a worsening HF event']",[],"[{'cui': 'C0003015', 'cui_str': 'ACE Inhibitors'}, {'cui': 'C0815017', 'cui_str': 'Angiotensin Receptor Blockers'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0330390', 'cui_str': 'Beta (organism)'}, {'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0012798', 'cui_str': 'Diuretics'}, {'cui': 'C0035096'}, {'cui': 'C0012265', 'cui_str': 'Digoxin'}, {'cui': 'C1579268', 'cui_str': 'Mineralocorticoid Antagonists'}, {'cui': 'C4033631', 'cui_str': 'sacubitril / valsartan'}, {'cui': 'C0257190', 'cui_str': 'ivabradine'}, {'cui': 'C2828363', 'cui_str': 'Implant'}, {'cui': 'C0180307', 'cui_str': 'Defibrillators'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C1167956', 'cui_str': 'Cardiac Resynchronization'}, {'cui': 'C3273807', 'cui_str': 'Gliflozins'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}]",4744.0,0.252091,"Overall, the dapagliflozin vs. placebo hazard ratio (HR) was 0.74 [95% confidence interval (CI) 0.65-0.85] for the primary composite endpoint (P < 0.0001).","[{'ForeName': 'Kieran F', 'Initials': 'KF', 'LastName': 'Docherty', 'Affiliation': 'BHF Cardiovascular Research Centre, University of Glasgow, 126 University Place, Glasgow G12 8TA, UK.'}, {'ForeName': 'Pardeep S', 'Initials': 'PS', 'LastName': 'Jhund', 'Affiliation': 'BHF Cardiovascular Research Centre, University of Glasgow, 126 University Place, Glasgow G12 8TA, UK.'}, {'ForeName': 'Silvio E', 'Initials': 'SE', 'LastName': 'Inzucchi', 'Affiliation': 'Section of Endocrinology, Yale University School of Medicine, 333 Cedar Street, New Haven, CT 06510 USA.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Køber', 'Affiliation': 'Rigshospitalet Copenhagen University Hospital, Blegdamsvej 9, 2100 Copenhagen, Denmark.'}, {'ForeName': 'Mikhail N', 'Initials': 'MN', 'LastName': 'Kosiborod', 'Affiliation': ""Saint Luke's Mid America Heart Institute and University of Missouri-Kansas City, 4401 Wornall Road, Kansas City, MO 64111, USA.""}, {'ForeName': 'Felipe A', 'Initials': 'FA', 'LastName': 'Martinez', 'Affiliation': 'National University of Cordoba, Av.Colon 2057, Cordoba X5003DSE, Argentina.'}, {'ForeName': 'Piotr', 'Initials': 'P', 'LastName': 'Ponikowski', 'Affiliation': 'Wroclaw Medical University, Borowska 213, Wroclaw 50-556, Poland.'}, {'ForeName': 'David L', 'Initials': 'DL', 'LastName': 'DeMets', 'Affiliation': 'Department of Biostatistics & Medical Informatics, University of Wisconsin, 610 Walnut Street, 250 WARF, Madison, WI 53726, USA.'}, {'ForeName': 'Marc S', 'Initials': 'MS', 'LastName': 'Sabatine', 'Affiliation': ""TIMI Study Group, Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, 60 Fenwood Road, Boston, MA 02115 USA.""}, {'ForeName': 'Olof', 'Initials': 'O', 'LastName': 'Bengtsson', 'Affiliation': 'Late Stage Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Pepparedsleden 1, Mölndal 431 83, Sweden.'}, {'ForeName': 'Mikaela', 'Initials': 'M', 'LastName': 'Sjöstrand', 'Affiliation': 'Late Stage Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Pepparedsleden 1, Mölndal 431 83, Sweden.'}, {'ForeName': 'Anna Maria', 'Initials': 'AM', 'LastName': 'Langkilde', 'Affiliation': 'Late Stage Development, Cardiovascular, Renal and Metabolism, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Pepparedsleden 1, Mölndal 431 83, Sweden.'}, {'ForeName': 'Akshay S', 'Initials': 'AS', 'LastName': 'Desai', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital, 75 Francis Street, Boston, MA 02115, USA.""}, {'ForeName': 'Mirta', 'Initials': 'M', 'LastName': 'Diez', 'Affiliation': 'Division of Cardiology, Institute Cardiovascular de Buenos Aires, Av. Libertador 6302, C1428ART - Buenos Aires, Argentina.'}, {'ForeName': 'Jonathan G', 'Initials': 'JG', 'LastName': 'Howlett', 'Affiliation': 'University of Calgary, Cardiac Sciences and Medicine, Room c838, 1403- 29th street NW, Calgary Alberta Canada, T2N2Y9.'}, {'ForeName': 'Tzvetana', 'Initials': 'T', 'LastName': 'Katova', 'Affiliation': 'Clinic of Cardiology, National Cardiology Hospital, 65 Konyovitsa Str., Sofia 1309, Bulgaria.'}, {'ForeName': 'Charlotta E A', 'Initials': 'CEA', 'LastName': 'Ljungman', 'Affiliation': 'Department of Molecular and Clinical Medicine and Cardiology, Sahlgrenska Academy, Gothenburg 413 45, Sweden.'}, {'ForeName': 'Eileen', 'Initials': 'E', 'LastName': ""O'Meara"", 'Affiliation': 'Montreal Heart Institute, University of Montreal, 5000 Belanger, Montreal, Quebec H1T1C8, Canada.'}, {'ForeName': 'Mark C', 'Initials': 'MC', 'LastName': 'Petrie', 'Affiliation': 'BHF Cardiovascular Research Centre, University of Glasgow, 126 University Place, Glasgow G12 8TA, UK.'}, {'ForeName': 'Morten', 'Initials': 'M', 'LastName': 'Schou', 'Affiliation': 'Department of Cardiology, Gentofte University Hospital, Herlev Ringvej 75, 2730 Herlev, Denmark.'}, {'ForeName': 'Subodh', 'Initials': 'S', 'LastName': 'Verma', 'Affiliation': ""Division of Cardiac Surgery, St. Michael's Hospital, University of Toronto, 30 Bond Street, Toronto, Canada M5B 1W8.""}, {'ForeName': 'Pham Nguyen', 'Initials': 'PN', 'LastName': 'Vinh', 'Affiliation': 'Department of Internal Medicine, Tan Tao University, Tan Duc Cardiology Hospital, No. 04 Nguyen Luong Bang, Tan Phu Ward, District 7, Ho Chi Minh City 70000, Vietnam.'}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Solomon', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital, 75 Francis Street, Boston, MA 02115, USA.""}, {'ForeName': 'John J V', 'Initials': 'JJV', 'LastName': 'McMurray', 'Affiliation': 'BHF Cardiovascular Research Centre, University of Glasgow, 126 University Place, Glasgow G12 8TA, UK.'}]",European heart journal,['10.1093/eurheartj/ehaa183'] 495,32221596,A putative placebo analysis of the effects of sacubitril/valsartan in heart failure across the full range of ejection fraction.,"AIMS The PARADIGM-HF and PARAGON-HF trials tested sacubitril/valsartan against active controls given renin-angiotensin system inhibitors (RASi) are ethically mandated in heart failure (HF) with reduced ejection fraction and are used in the vast majority of patients with HF with preserved ejection fraction. To estimate the effects of sacubitril/valsartan had it been tested against a placebo control, we made indirect comparisons of the effects of sacubitril/valsartan with putative placebos in HF across the full range of left ventricular ejection fraction (LVEF). METHODS AND RESULTS We analysed patient-level data from the PARADIGM-HF and PARAGON-HF trials (n = 13 194) and the CHARM-Alternative and CHARM-Preserved trials (n = 5050, candesartan vs. placebo). The rate ratio (RR) of sacubitril/valsartan vs. putative placebo was estimated by the product of the RR for sacubitril/valsartan vs. RASi and the RR for RASi vs. placebo. Total HF hospitalizations and cardiovascular death were analysed using the negative binomial method. Treatment effects were estimated using cubic spline methods by ejection fraction as a continuous measure. Across the range of LVEF, sacubitril/valsartan was associated with a RR 0.54 [95% confidence interval (CI) 0.45-0.65] for the recurrent primary endpoint compared with putative placebo (P < 0.001). Treatment benefits of sacubitril/valsartan vs. putative placebo varied non-linearly with LVEF with attenuation of effects observed at LVEF above 60%. When analyzing data from PARADIGM-HF and CHARM-Alternative, the estimated risk reduction of sacubitril/valsartan vs. putative placebo was 48% (95% CI 35-58%); P < 0.001. When analyzing data from PARAGON-HF and CHARM-Preserved (with LVEF ≥ 45%), the estimated risk reduction of sacubitril/valsartan vs. putative placebo was 29% (95% CI 7-46%); P = 0.013. Across the full range of LVEF, consistent effects were observed for time-to-first endpoints: first primary endpoint (RR 0.72, 95% CI 0.64-0.82), first HF hospitalization (RR 0.67, 95% CI 0.58-0.78), cardiovascular death (RR 0.76, 95% CI 0.64-0.89), and all-cause death (RR 0.83, 95% CI 0.71-0.96); all P < 0.02. CONCLUSION This putative placebo analysis reinforces the treatment benefits of sacubitril/valsartan on risk of adverse cardiovascular events across the full range of LVEF, with most pronounced effects observed at a LVEF up to 60%.",2020,"Across the full range of LVEF, consistent effects were observed for time-to-first endpoints: first primary endpoint (RR 0.72, 95% CI 0.64-0.82), first HF hospitalization (RR 0.67, 95% CI 0.58-0.78), cardiovascular death (RR 0.76, 95% CI 0.64-0.89), and all-cause death (RR 0.83, 95% CI 0.71-0.96); all P < 0.02. CONCLUSION ",['patients with HF with preserved ejection fraction'],"['placebo', 'sacubitril/valsartan vs. putative placebo', 'valsartan against active controls given renin-angiotensin system inhibitors (RASi', 'sacubitril/valsartan', 'sacubitril/valsartan with putative placebos', 'CHARM-Alternative and CHARM-Preserved trials (n\u2009=\u20095050, candesartan vs. placebo']","['heart failure across the full range of ejection fraction', 'Total HF hospitalizations and cardiovascular death', 'HF hospitalization', 'cause death', 'rate ratio (RR', 'cardiovascular death']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0728887', 'cui_str': 'Preserving (attribute)'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4033631', 'cui_str': 'sacubitril / valsartan'}, {'cui': 'C0216784', 'cui_str': 'valsartan'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0035096'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0728887', 'cui_str': 'Preserving (attribute)'}, {'cui': 'C0717550', 'cui_str': 'candesartan'}]","[{'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",,0.430989,"Across the full range of LVEF, consistent effects were observed for time-to-first endpoints: first primary endpoint (RR 0.72, 95% CI 0.64-0.82), first HF hospitalization (RR 0.67, 95% CI 0.58-0.78), cardiovascular death (RR 0.76, 95% CI 0.64-0.89), and all-cause death (RR 0.83, 95% CI 0.71-0.96); all P < 0.02. CONCLUSION ","[{'ForeName': 'Muthiah', 'Initials': 'M', 'LastName': 'Vaduganathan', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, 75 Francis St, Boston, MA 02115, USA.""}, {'ForeName': 'Pardeep S', 'Initials': 'PS', 'LastName': 'Jhund', 'Affiliation': 'British Heart Foundation Cardiovascular Research Centre, Institute of Cardiovascular and Medical Sciences, University of Glasgow, 126 University Place, Glasgow G12 8TA, UK.'}, {'ForeName': 'Brian L', 'Initials': 'BL', 'LastName': 'Claggett', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, 75 Francis St, Boston, MA 02115, USA.""}, {'ForeName': 'Milton', 'Initials': 'M', 'LastName': 'Packer', 'Affiliation': 'Baylor Heart and Vascular Institute, Baylor University Medical Center, 3500 Gaston Avenue, Dallas, TX 75246, USA.'}, {'ForeName': 'Jiri', 'Initials': 'J', 'LastName': 'Widimský', 'Affiliation': 'Department of Medicine III, Charles University in Prague, First Faculty of Medicine, Katerinská 32, CZ-121 08 Prague 2, Czech Republic.'}, {'ForeName': 'Petar', 'Initials': 'P', 'LastName': 'Seferovic', 'Affiliation': 'Heart Failure Center, Faculty of Medicine, University of Belgrade, 8 Koste Todorovića, Belgrade 11000, Serbia.'}, {'ForeName': 'Adel', 'Initials': 'A', 'LastName': 'Rizkala', 'Affiliation': 'Global Drug Development, Novartis Pharmaceuticals, 1 Health Plaza, East Hanover, NJ 07936, USA.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Lefkowitz', 'Affiliation': 'Global Drug Development, Novartis Pharmaceuticals, 1 Health Plaza, East Hanover, NJ 07936, USA.'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Shi', 'Affiliation': 'Global Drug Development, Novartis Pharmaceuticals, 1 Health Plaza, East Hanover, NJ 07936, USA.'}, {'ForeName': 'John J V', 'Initials': 'JJV', 'LastName': 'McMurray', 'Affiliation': 'British Heart Foundation Cardiovascular Research Centre, Institute of Cardiovascular and Medical Sciences, University of Glasgow, 126 University Place, Glasgow G12 8TA, UK.'}, {'ForeName': 'Scott D', 'Initials': 'SD', 'LastName': 'Solomon', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, 75 Francis St, Boston, MA 02115, USA.""}]",European heart journal,['10.1093/eurheartj/ehaa184'] 496,32030863,Association between uric acid levels and cardio-renal outcomes and death in patients with type 2 diabetes: A subanalysis of EMPA-REG OUTCOME.,"In the EMPA-REG OUTCOME trial, we explored the association between pre-randomization uric acid level tertile (<309.30 μmol/L; 309.30 to <387.21 μmol/L; ≥387.21 μmol/L) and cardiovascular (CV) death, hospitalization for heart failure (HHF), HHF or CV death, all-cause mortality, three-point major adverse CV events (MACE), and incident or worsening nephropathy. Patients with type 2 diabetes and CV disease received empagliflozin or placebo. The median baseline plasma uric acid level was 344.98 μmol/L, and patients' baseline characteristics were mainly balanced across tertiles. Baseline uric acid levels were associated with cardio-renal outcomes: in the placebo group, for the highest versus lowest tertile, the multivariable hazard ratios for three-point MACE, HHF or CV death, and incident or worsening nephropathy were 1.22 (95% confidence interval [CI] 0.89-1.67; P = 0.2088), 1.51 (95% CI 1.02-2.23; P = 0.0396) and 1.77 (95% CI 1.33-2.34; P < 0.0001), respectively. When tested as a continuous variable, baseline uric acid was associated with all outcomes in the placebo group. Empagliflozin improved all cardio-renal outcomes across tertiles, with all interaction P values >0.05. Further investigation of these relationships is required.",2020,"Empagliflozin improved all cardio-renal outcomes across tertiles, with all interaction P values > 0.05.","['Patients with type 2 diabetes and CV disease received', 'Patients with Type 2 Diabetes']","['empagliflozin or placebo', 'placebo', 'Empagliflozin']","['cardiovascular (CV) death, hospitalization for heart failure (HHF), HHF or CV death, all-cause mortality, 3-point major adverse CV events (3P-MACE), and incident or worsening nephropathy', 'cardio-renal outcomes', 'Baseline uric acid levels', 'Uric Acid Levels and Cardio-renal Outcomes and Death', 'pre-randomization uric acid levels tertiles', 'multivariable hazard ratios for 3P-MACE, HHF or CV death, and incident or worsening nephropathy', 'Median baseline plasma uric acid']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C3490348', 'cui_str': 'empagliflozin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0349381', 'cui_str': 'Mace (substance)'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0022658', 'cui_str': 'Kidney Diseases'}, {'cui': 'C0041980', 'cui_str': 'Uric Acid'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0857451', 'cui_str': 'Plasma uric acid'}]",,0.353279,"Empagliflozin improved all cardio-renal outcomes across tertiles, with all interaction P values > 0.05.","[{'ForeName': 'Subodh', 'Initials': 'S', 'LastName': 'Verma', 'Affiliation': ""St Michael's Hospital, Division of Cardiac Surgery, University of Toronto, Toronto, Ontario, Canada.""}, {'ForeName': 'Qiuhe', 'Initials': 'Q', 'LastName': 'Ji', 'Affiliation': ""Xijing Hospital, Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Deepak L', 'Initials': 'DL', 'LastName': 'Bhatt', 'Affiliation': ""Brigham and Women's Hospital Heart and Vascular Centre and Harvard Medical School, Boston, Massachusetts, USA.""}, {'ForeName': 'C David', 'Initials': 'CD', 'LastName': 'Mazer', 'Affiliation': ""St Michael's Hospital, Department of Anaesthesia, University of Toronto, Toronto, Ontario, Canada.""}, {'ForeName': 'Mohammed', 'Initials': 'M', 'LastName': 'Al-Omran', 'Affiliation': ""St Michael's Hospital, Division of Vascular Surgery, University of Toronto, Toronto, Ontario, Canada.""}, {'ForeName': 'Silvio E', 'Initials': 'SE', 'LastName': 'Inzucchi', 'Affiliation': 'Yale University School of Medicine, New Haven, Connecticut, USA.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Wanner', 'Affiliation': 'Würzburg University Clinic, Würzburg, Germany.'}, {'ForeName': 'Anne Pernille', 'Initials': 'AP', 'LastName': 'Ofstad', 'Affiliation': 'Boehringer Ingelheim Norway KS, Asker, Norway.'}, {'ForeName': 'Isabella', 'Initials': 'I', 'LastName': 'Zwiener', 'Affiliation': 'Boehringer Ingelheim Pharma GmbH & Co KG, Ingelheim, Germany.'}, {'ForeName': 'Jyothis T', 'Initials': 'JT', 'LastName': 'George', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim, Germany.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Zinman', 'Affiliation': 'Lunenfeld-Tanenbaum Research Institute, Mount Sinai Hospital, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Fitchett', 'Affiliation': ""St Michael's Hospital, Division of Cardiology, University of Toronto, Toronto, Ontario, Canada.""}]","Diabetes, obesity & metabolism",['10.1111/dom.13991'] 497,32166899,"Angiogenic T cells are decreased in people with type 2 diabetes mellitus and recruited by the dipeptidyl peptidase-4 inhibitor Linagliptin: A subanalysis from a randomized, placebo-controlled trial (RELEASE study).","Angiogenic T (Tang) cells are mediators of vascular repair, and are characterized by surface expression of CXCR4. This receptor for stromal cell-derived factor-1α (SDF-1α) is cleaved by dipeptidyl peptidase-4 (DPP-4). Tang cell levels were investigated in people with type 2 diabetes mellitus (T2DM) compared with matched healthy controls and after treatment with the DPP-4 inhibitor Linagliptin. People with T2DM were randomized to 5 mg/day Linagliptin (n = 20) or placebo (n = 21) for 26 weeks. Tang cell frequency was identified in peripheral blood mononuclear cells (CD3 + CD31 + CXCR4 + ) and levels of endothelial progenitor cells (EPCs) (CD34 + CD133 + KDR + ) were also assessed in whole blood. Circulating Tang cell levels were significantly lower in people with T2DM compared with the healthy control group. SDF-1α levels increased significantly in Linagliptin-treated people with T2DM compared to placebo, and a trend was observed in change of Tang cell levels, while EPC count did not change. In conclusion, circulating Tang cell levels were considerably lower in people with T2DM, while a trend was observed in recruitment of Tang cells after 26 weeks of treatment with Linagliptin. These data suggest that DPP-4 inhibitors may potentially exert beneficial effects on bone marrow-driven vascular repair.",2020,"SDF-1α levels increased significantly in Linagliptin treated people with T2DM compared to placebo, and a trend was observed in change of Tang cells, while EPC count did not change.","['people with type 2 diabetes mellitus', 'people with type 2 diabetes mellitus (T2DM) compared with matched healthy controls (HC) and after treatment with the', 'People with T2DM']","['dipeptidyl peptidase-4 inhibitor Linagliptin', 'Linagliptin', 'placebo', 'DPP4-inhibitor Linagliptin']","['change of Tang cells, while EPC count', 'Circulating Tang cell levels', 'circulating Tang cells', 'SDF-1α levels', 'Angiogenic T (Tang) cells', 'Angiogenic T cells', 'recruitment of Tang cells', 'peripheral blood mononuclear cells (CD3\u2009+\u2009CD31 + CXCR4 + ) and levels of endothelial progenitor cells (EPCs, CD34 + CD133 + KDR + ']","[{'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0001758', 'cui_str': 'Follow-Up Care'}]","[{'cui': 'C1827106', 'cui_str': 'Dipeptidyl-Peptidase 4 Inhibitors'}, {'cui': 'C2746078', 'cui_str': 'Linagliptin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0169014', 'cui_str': 'erucylphosphocholine'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0039194', 'cui_str': 'Thymus-Dependent Lymphocytes'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C1321301', 'cui_str': 'Peripheral blood mononuclear cell'}, {'cui': 'C3850017', 'cui_str': 'Circulating Endothelial Progenitor Cells'}]",,0.187892,"SDF-1α levels increased significantly in Linagliptin treated people with T2DM compared to placebo, and a trend was observed in change of Tang cells, while EPC count did not change.","[{'ForeName': 'Stefanie A', 'Initials': 'SA', 'LastName': 'de Boer', 'Affiliation': 'Department of Internal Medicine, Division of Vascular Medicine, University of Groningen, University Medical Centre Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Reijrink', 'Affiliation': 'Department of Internal Medicine, Division of Vascular Medicine, University of Groningen, University Medical Centre Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Wayel H', 'Initials': 'WH', 'LastName': 'Abdulahad', 'Affiliation': 'Department of Rheumatology and Clinical Immunology, University of Groningen, University Medical Centre Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Elisa S', 'Initials': 'ES', 'LastName': 'Hoekstra', 'Affiliation': 'Department of Rheumatology and Clinical Immunology, University of Groningen, University Medical Centre Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Riemer H J A', 'Initials': 'RHJA', 'LastName': 'Slart', 'Affiliation': 'Department of Nuclear Medicine and Molecular Imaging, University of Groningen, University Medical Centre Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Hiddo J L', 'Initials': 'HJL', 'LastName': 'Heerspink', 'Affiliation': 'Department of Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Centre Groningen, Groningen, Netherlands.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Westra', 'Affiliation': 'Department of Rheumatology and Clinical Immunology, University of Groningen, University Medical Centre Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Douwe J', 'Initials': 'DJ', 'LastName': 'Mulder', 'Affiliation': 'Department of Internal Medicine, Division of Vascular Medicine, University of Groningen, University Medical Centre Groningen, Groningen, The Netherlands.'}]","Diabetes, obesity & metabolism",['10.1111/dom.14024'] 498,31830433,Two Weeks of Wearing a Knee Brace Compared With Minimal Intervention on Kinesiophobia at 2 and 6 Weeks in People With Patellofemoral Pain: A Randomized Controlled Trial.,"OBJECTIVE To investigate the effect of a knee brace compared with minimal intervention on self-reported kinesiophobia and function, objective function, and physical activity level in people with patellofemoral pain (PFP). DESIGN Single-blind randomized controlled trial (1:1), parallel. PARTICIPANTS Individuals with PFP (N=50). MAIN OUTCOME MEASURES Primary: kinesiophobia (Tampa Scale for Kinesiophobia). Secondary: self-reported function (Anterior Knee Pain Scale), physical activity level (International Physical Activity Questionnaire), and objective function (forward step-down test). Outcomes were assessed at baseline (T 0 ), at the end of the intervention (2wk) (T 1 ), and at 6 weeks after baseline (T 2 ). INTERVENTION Participants were randomly assigned to 1 of 2 interventions groups: (1) use of knee brace for 2 weeks during daily living, sports, or painful tasks (brace group) and (2) educational leaflet with information about PFP (leaflet group). RESULTS The knee brace reduced kinesiophobia in people with PFP compared with minimal intervention with moderate effect size at T 1 =mean difference (95% CI) -5.56 (-9.18 to -1.93) and T 2 =-5.24 (-8.58 to -1.89). There was no significant difference in self-reported and objective function and physical activity level. CONCLUSIONS The knee brace improved kinesiophobia immediately after intervention (at 2wk) and at 6-week follow-up in people with PFP compared with minimal intervention. A knee brace may be considered within clinically reasoned paradigms to facilitate exercise therapy interventions for people with PFP.",2020,The knee brace reduced kinesiophobia in people with PFP compared with minimal intervention with moderate effect size at T 1 =mean difference (95% CI),"['people with PFP', 'people with patellofemoral pain (PFP', 'Individuals with PFP (N=50', 'People With Patellofemoral Pain']","['Wearing a Knee Brace Compared With Minimal Intervention on Kinesiophobia', 'knee brace for 2 weeks during daily living, sports, or painful tasks (brace group) and (2) educational leaflet with information about PFP (leaflet group', 'minimal intervention', 'knee brace']","['self-reported and objective function and physical activity level', 'self-reported kinesiophobia and function, objective function, and physical activity level', 'Secondary: self-reported function (Anterior Knee Pain Scale), physical activity level (International Physical Activity Questionnaire), and objective function (forward step-down test']","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0006086', 'cui_str': 'Braces'}, {'cui': 'C0547040', 'cui_str': 'Minimal (qualifier value)'}, {'cui': 'C4285782', 'cui_str': 'Kinesiophobia'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0038039', 'cui_str': 'Sports'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C4285782', 'cui_str': 'Kinesiophobia'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0409326', 'cui_str': 'Anterior knee pain (finding)'}, {'cui': 'C0222045'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439780', 'cui_str': 'Forward (qualifier value)'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}]",,0.11886,The knee brace reduced kinesiophobia in people with PFP compared with minimal intervention with moderate effect size at T 1 =mean difference (95% CI),"[{'ForeName': 'Liliam B', 'Initials': 'LB', 'LastName': 'Priore', 'Affiliation': 'Department of Physiotherapy, School of Science and Technology, Sao Paulo State University (UNESP), Presidente Prudente, Brazil.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Lack', 'Affiliation': 'Sports and Exercise Medicine, William Harvey Research Institute, School of Medicine and Dentistry, Queen Mary University London, London, United Kingdom.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Garcia', 'Affiliation': 'Department of Physiotherapy, School of Science and Technology, Sao Paulo State University (UNESP), Presidente Prudente, Brazil.'}, {'ForeName': 'Fabio M', 'Initials': 'FM', 'LastName': 'Azevedo', 'Affiliation': 'Department of Physiotherapy, School of Science and Technology, Sao Paulo State University (UNESP), Presidente Prudente, Brazil.'}, {'ForeName': 'Danilo', 'Initials': 'D', 'LastName': 'de Oliveira Silva', 'Affiliation': 'Department of Physiotherapy, School of Science and Technology, Sao Paulo State University (UNESP), Presidente Prudente, Brazil; La Trobe Sport and Exercise Medicine Research Centre (LASEM), School of Allied Health, La Trobe University, Melbourne, Australia. Electronic address: danilo110190@hotmail.com.'}]",Archives of physical medicine and rehabilitation,['10.1016/j.apmr.2019.10.190'] 499,30705390,Screening and brief intervention for obesity in primary care: cost-effectiveness analysis in the BWeL trial.,"BACKGROUND The Brief Intervention for Weight Loss Trial enrolled 1882 consecutively attending primary care patients who were obese and participants were randomised to physicians opportunistically endorsing, offering, and facilitating a referral to a weight loss programme (support) or recommending weight loss (advice). After one year, the support group lost 1.4 kg more (95%CI 0.9 to 2.0): 2.4 kg versus 1.0 kg. We use a cohort simulation to predict effects on disease incidence, quality of life, and healthcare costs over 20 years. METHODS Randomly sampling from the trial population, we created a virtual cohort of 20 million adults and assigned baseline morbidity. We applied the weight loss observed in the trial and assumed weight regain over four years. Using epidemiological data, we assigned the incidence of 12 weight-related diseases depending on baseline disease status, age, gender, body mass index. From a healthcare perspective, we calculated the quality adjusted life years (QALYs) accruing and calculated the incremental difference between trial arms in costs expended in delivering the intervention and healthcare costs accruing. We discounted future costs and benefits at 1.5% over 20 years. RESULTS Compared with advice, the support intervention reduced the cumulative incidence of weight-related disease by 722/100,000 people, 0.33% of all weight-related disease. The incremental cost of support over advice was £2.01million/100,000. However, the support intervention reduced health service costs by £5.86 million/100,000 leading to a net saving of £3.85 million/100,000. The support intervention produced 992 QALYs/100,000 people relative to advice. CONCLUSIONS A brief intervention in which physicians opportunistically endorse, offer, and facilitate a referral to a behavioural weight management service to patients with a BMI of at least 30 kg/m 2 reduces healthcare costs and improves health more than advising weight loss.",2019,"Compared with advice, the support intervention reduced the cumulative incidence of weight-related disease by 722/100,000 people, 0.33% of all weight-related disease.","['Randomly sampling from the trial population, we created a virtual cohort of 20 million adults and assigned baseline morbidity', 'patients with a BMI of at least 30\u2009kg/m 2 reduces healthcare costs and improves health more than advising weight loss', '1882 consecutively attending primary care patients who were obese and participants']","['physicians opportunistically endorsing, offering, and facilitating a referral to a weight loss programme (support) or recommending weight loss (advice']","['disease incidence, quality of life, and healthcare costs', 'cumulative incidence of weight-related disease', 'weight loss', 'health service costs']","[{'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0085552', 'cui_str': 'Healthcare Costs'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C2585021', 'cui_str': 'Referral to'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}]","[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0034380'}, {'cui': 'C0085552', 'cui_str': 'Healthcare Costs'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0018747', 'cui_str': 'Health Services'}, {'cui': 'C0010186', 'cui_str': 'Cost'}]",1882.0,0.159942,"Compared with advice, the support intervention reduced the cumulative incidence of weight-related disease by 722/100,000 people, 0.33% of all weight-related disease.","[{'ForeName': 'Lise', 'Initials': 'L', 'LastName': 'Retat', 'Affiliation': 'UK Health Forum, Fleetbank House, 2-6 Salisbury Square, London, EC4Y 8JX, UK.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Pimpin', 'Affiliation': 'UK Health Forum, Fleetbank House, 2-6 Salisbury Square, London, EC4Y 8JX, UK.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Webber', 'Affiliation': 'UK Health Forum, Fleetbank House, 2-6 Salisbury Square, London, EC4Y 8JX, UK.'}, {'ForeName': 'Abbygail', 'Initials': 'A', 'LastName': 'Jaccard', 'Affiliation': 'UK Health Forum, Fleetbank House, 2-6 Salisbury Square, London, EC4Y 8JX, UK.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Lewis', 'Affiliation': 'Population Health Sciences, Bristol Medical School, University of Bristol, Canynge Hall, 39 Whatley Road, Bristol, BS8 2PS, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Tearne', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Radcliffe Observatory Quarter, Woodstock Road, Oxford, OX2 6GG, UK.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Hood', 'Affiliation': 'Population Health Sciences, Bristol Medical School, University of Bristol, Canynge Hall, 39 Whatley Road, Bristol, BS8 2PS, UK.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Christian-Brown', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Radcliffe Observatory Quarter, Woodstock Road, Oxford, OX2 6GG, UK.'}, {'ForeName': 'Peymane', 'Initials': 'P', 'LastName': 'Adab', 'Affiliation': 'Institute of Applied Health Research, University of Birmingham, Edgbaston, Birmingham, West Midlands, B15 2TT, UK.'}, {'ForeName': 'Rachna', 'Initials': 'R', 'LastName': 'Begh', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Radcliffe Observatory Quarter, Woodstock Road, Oxford, OX2 6GG, UK.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Jolly', 'Affiliation': 'Institute of Applied Health Research, University of Birmingham, Edgbaston, Birmingham, West Midlands, B15 2TT, UK.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Daley', 'Affiliation': 'School of Sport, Exercise and Health Sciences, Loughborough University, Ashby Road, Loughborough, Leicestershire, LE11 3TU, UK.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Farley', 'Affiliation': 'Institute of Applied Health Research, University of Birmingham, Edgbaston, Birmingham, West Midlands, B15 2TT, UK.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Lycett', 'Affiliation': 'Faculty of Health and Life Sciences, Coventry University, Priory Street, Coventry, CV1 5FB, UK.'}, {'ForeName': 'Alecia', 'Initials': 'A', 'LastName': 'Nickless', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Radcliffe Observatory Quarter, Woodstock Road, Oxford, OX2 6GG, UK.'}, {'ForeName': 'Ly-Mee', 'Initials': 'LM', 'LastName': 'Yu', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Radcliffe Observatory Quarter, Woodstock Road, Oxford, OX2 6GG, UK.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Jebb', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Radcliffe Observatory Quarter, Woodstock Road, Oxford, OX2 6GG, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Aveyard', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Radcliffe Observatory Quarter, Woodstock Road, Oxford, OX2 6GG, UK. paul.aveyard@phc.ox.ac.uk.'}]",International journal of obesity (2005),['10.1038/s41366-018-0295-7'] 500,32213141,"Effect of soluble-viscous dietary fibre on coronary heart disease risk score across 3 population health categories: data from randomized, double-blind, placebo-controlled trials.","We applied the Framingham risk equation in healthy, metabolic syndrome, and diabetes populations, following treatment with viscous fibre from konjac-based blend (KBB). KBB yielded reduction in estimated risk score by 16% (1.04 ± 0.03 vs. 0.87 ± 0.04, p < 0.01) in type 2 diabetes, 24% (1.08 ± 0.01 vs. 0.82 ± 0.02, p < 0.01) in metabolic syndrome, and 25% (1.09 ± 0.05 vs. 0.82 ± 0.06, p < 0.01) in healthy individuals. Drivers for decreased risk were improvements in blood cholesterol and systolic blood pressure. The composite coronary heart disease risk across populations was reduced 22% ( p < 0.01). Novelty Viscous fibre from konjac-xanthan reduced 10-year relative coronary heart disease using Framingham Risk Score across the glycemic status spectrum.",2020,The composite coronary heart disease risk across populations was reduced 22% (p<0.01).,['coronary heart disease risk score across three population health categories'],"['viscous fibre from konjac-based blend (KBB', 'soluble-viscous dietary fibre', 'Novelty Bullet: Viscous fibre from konjac-xanthan', 'placebo']","['estimated risk score', 'blood cholesterol and systolic blood pressure']","[{'cui': 'C1277690', 'cui_str': 'Coronary heart disease risk'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C3242284', 'cui_str': 'Population Health'}]","[{'cui': 'C0225326', 'cui_str': 'Fiber'}, {'cui': 'C1135791', 'cui_str': 'Konjac'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0012173', 'cui_str': 'Dietary Fiber'}, {'cui': 'C0336699', 'cui_str': 'Bullet, device (physical object)'}, {'cui': 'C0078596', 'cui_str': 'xanthan gum'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0518017', 'cui_str': 'Blood cholesterol'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}]",,0.15749,The composite coronary heart disease risk across populations was reduced 22% (p<0.01).,"[{'ForeName': 'Vladimir', 'Initials': 'V', 'LastName': 'Vuksan', 'Affiliation': ""Clinical Nutrition and Risk Factor Modification Center, St. Michael's Hospital, Toronto, ON M5B 1W8, Canada.""}, {'ForeName': 'John L', 'Initials': 'JL', 'LastName': 'Sievenpiper', 'Affiliation': ""Clinical Nutrition and Risk Factor Modification Center, St. Michael's Hospital, Toronto, ON M5B 1W8, Canada.""}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Jovanovski', 'Affiliation': ""Clinical Nutrition and Risk Factor Modification Center, St. Michael's Hospital, Toronto, ON M5B 1W8, Canada.""}, {'ForeName': 'Alexandra L', 'Initials': 'AL', 'LastName': 'Jenkins', 'Affiliation': ""Clinical Nutrition and Risk Factor Modification Center, St. Michael's Hospital, Toronto, ON M5B 1W8, Canada.""}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Komishon', 'Affiliation': ""Clinical Nutrition and Risk Factor Modification Center, St. Michael's Hospital, Toronto, ON M5B 1W8, Canada.""}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Au-Yeung', 'Affiliation': ""Clinical Nutrition and Risk Factor Modification Center, St. Michael's Hospital, Toronto, ON M5B 1W8, Canada.""}, {'ForeName': 'Andreea', 'Initials': 'A', 'LastName': 'Zurbau', 'Affiliation': ""Clinical Nutrition and Risk Factor Modification Center, St. Michael's Hospital, Toronto, ON M5B 1W8, Canada.""}, {'ForeName': 'Hoang V T', 'Initials': 'HVT', 'LastName': 'Ho', 'Affiliation': ""Clinical Nutrition and Risk Factor Modification Center, St. Michael's Hospital, Toronto, ON M5B 1W8, Canada.""}, {'ForeName': 'Dandan', 'Initials': 'D', 'LastName': 'Li', 'Affiliation': ""Clinical Nutrition and Risk Factor Modification Center, St. Michael's Hospital, Toronto, ON M5B 1W8, Canada.""}, {'ForeName': 'Lea', 'Initials': 'L', 'LastName': 'Smircic-Duvnjak', 'Affiliation': 'Clinic for Diabetes, Endocrinology & Metabolic Diseases Vuk Vrhovac, University Hospital Merkur, University of Zagreb, School of Medicine, Zagreb, Croatia.'}]","Applied physiology, nutrition, and metabolism = Physiologie appliquee, nutrition et metabolisme",['10.1139/apnm-2019-0728'] 501,30538282,Prefronto-cerebellar neuromodulation affects appetite in obesity.,"Human neuroimaging studies have consistently reported changes in cerebellar function and integrity in association with obesity. To date, however, the nature of this link has not been studied directly. Emerging evidence suggests a role for the cerebellum in higher cognitive functions through reciprocal connections with the prefrontal cortex. The purpose of this exploratory study was to examine appetite changes associated with noninvasive prefronto-cerebellar neuromodulation in obesity. Totally, 12 subjects with class I obesity (mean body mass index 32.9 kg/m 2 ) underwent a randomized, single-blinded, sham-controlled, crossover study, during which they received transcranial direct current stimulation ((tDCS); active/sham) aimed at simultaneously enhancing the activity of the prefrontal cortex and decreasing the activity of the cerebellum. Changes in appetite (state and food-cue-triggered) and performance in a food-modified working memory task were evaluated. We found that active tDCS caused an increase in hunger and desire to eat following food-cue exposure. In line with these data, subjects also tended to make more errors during the working memory task. No changes in basic motor performance occurred. This study represents the first demonstration that prefronto-cerebellar neuromodulation can influence appetite in individuals with obesity. While preliminary, our findings support a potential role for prefronto-cerebellar pathways in the behavioral manifestations of obesity.",2019,Changes in appetite (state and food-cue-triggered) and performance in a food-modified working memory task were evaluated.,"['individuals with obesity', '12 subjects with class']","['transcranial direct current stimulation ((tDCS); active/sham', 'active tDCS', 'prefronto-cerebellar neuromodulation', 'Prefronto-cerebellar neuromodulation']","['basic motor performance', 'appetite (state and food-cue-triggered) and performance', 'hunger and desire to eat']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}]","[{'cui': 'C0003618', 'cui_str': 'Appetite'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C1444748', 'cui_str': 'Provoked by (attribute)'}, {'cui': 'C0020175', 'cui_str': 'Hunger'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}]",12.0,0.0223505,Changes in appetite (state and food-cue-triggered) and performance in a food-modified working memory task were evaluated.,"[{'ForeName': 'Elena M', 'Initials': 'EM', 'LastName': 'Marron', 'Affiliation': 'Cognitive NeuroLab, Faculty of Health Sciences, Universitat Oberta de Catalunya (UOC), Barcelona, Spain. emunozmarr@uoc.edu.'}, {'ForeName': 'Raquel', 'Initials': 'R', 'LastName': 'Viejo-Sobera', 'Affiliation': 'Cognitive NeuroLab, Faculty of Health Sciences, Universitat Oberta de Catalunya (UOC), Barcelona, Spain.'}, {'ForeName': 'Guillem', 'Initials': 'G', 'LastName': 'Cuatrecasas', 'Affiliation': 'Endocrinology Department, Clínica Sagrada Familia. Faculty of Health Sciences, Universitat Oberta de Catalunya (UOC), Barcelona, Spain.'}, {'ForeName': 'Diego', 'Initials': 'D', 'LastName': 'Redolar-Ripoll', 'Affiliation': 'Cognitive NeuroLab, Faculty of Health Sciences, Universitat Oberta de Catalunya (UOC), Barcelona, Spain.'}, {'ForeName': 'Pilar García', 'Initials': 'PG', 'LastName': 'Lorda', 'Affiliation': 'Cognitive NeuroLab, Faculty of Health Sciences, Universitat Oberta de Catalunya (UOC), Barcelona, Spain.'}, {'ForeName': 'Abhishek', 'Initials': 'A', 'LastName': 'Datta', 'Affiliation': 'Soterix Medical, New York City, NY, USA.'}, {'ForeName': 'Marom', 'Initials': 'M', 'LastName': 'Bikson', 'Affiliation': 'Department of Biomedical Engineering, City College of New York (CCNY), New York, NY, USA.'}, {'ForeName': 'Greta', 'Initials': 'G', 'LastName': 'Magerowski', 'Affiliation': 'Laboratory of Bariatric and Nutritional Neuroscience, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Alonso-Alonso', 'Affiliation': 'Laboratory of Bariatric and Nutritional Neuroscience, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA. malonso@bidmc.harvard.edu.'}]",International journal of obesity (2005),['10.1038/s41366-018-0278-8'] 502,30568260,Personalized nutrition: pretreatment glucose metabolism determines individual long-term weight loss responsiveness in individuals with obesity on low-carbohydrate versus low-fat diet.,"BACKGROUND/OBJECTIVES The interaction between fasting plasma glucose (FPG) and fasting insulin (FI) concentrations and diets with different carbohydrate content were studied as prognostic markers of weight loss as recent studies up to 6 months of duration have suggested the importance of these biomarkers. SUBJECTS/METHODS This was a retrospective analysis of a clinical trial where participants with obesity were randomized to an ad libitum low-carbohydrate diet or a low-fat diet with low energy content (1200-1800 kcal/day [≈ 5.0-7.5 MJ/d]; ≤ 30% calories from fat) for 24 months. Participants were categorized (pretreatment) as normoglycemic (FPG < 5.6 mmol/L) or prediabetic (FPG ≥ 5.6-6.9 mmol/L) and further stratified by median FI. Linear mixed models were used to examine outcomes by FPG and FI values. RESULTS After 2 years, participants with prediabetes and high FI lost 7.2  kg (95% CI 2.1;12.2, P = 0.005) more with the low-fat than low-carbohydrate diet, whereas those with prediabetes and low FI tended to lose 6.2  kg (95% CI -0.9;13.3, P = 0.088) more on the low-carbohydrate diet than low-fat diet [mean difference: 13.3 kg (95% CI 4.6;22.0, P = 0.003)]. No differences between diets were found among participants with normoglycemia and either high or low FI (both P ≥ 0.16). CONCLUSIONS Fasting plasma glucose and insulin are strong predictors of the weight loss response to diets with different macronutrient composition and might be a useful approach for personalized weight management.",2019,"No differences between diets were found among participants with normoglycemia and either high or low FI (both P ≥ 0.16). ","['Participants were categorized (pretreatment) as normoglycemic (FPG\u2009<\u20095.6\u2009mmol/L) or prediabetic (FPG\u2009≥\u20095.6-6.9\u2009mmol/L) and further stratified by median FI', 'individuals with obesity on low-carbohydrate versus low-fat diet', 'participants with obesity']",['ad libitum low-carbohydrate diet or a low-fat diet with low energy content'],['fasting plasma glucose (FPG) and fasting insulin (FI) concentrations'],"[{'cui': 'C0580545', 'cui_str': 'Blood glucose normal (finding)'}, {'cui': 'C4517794', 'cui_str': '5.6 (qualifier value)'}, {'cui': 'C1532563', 'cui_str': 'umol/mL'}, {'cui': 'C4517826', 'cui_str': 'Six point nine'}, {'cui': 'C0205363', 'cui_str': 'Stratified (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}, {'cui': 'C0242970', 'cui_str': 'Fat-Restricted Diet'}]","[{'cui': 'C0259836', 'cui_str': 'Diet, Carbohydrate-Restricted'}, {'cui': 'C0242970', 'cui_str': 'Fat-Restricted Diet'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}]","[{'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma (procedure)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",,0.0200382,"No differences between diets were found among participants with normoglycemia and either high or low FI (both P ≥ 0.16). ","[{'ForeName': 'Mads F', 'Initials': 'MF', 'LastName': 'Hjorth', 'Affiliation': 'Department of Nutrition, Exercise and Sports, Faculty of Sciences, University of Copenhagen, Copenhagen, Denmark. madsfiil@nexs.ku.dk.'}, {'ForeName': 'Arne', 'Initials': 'A', 'LastName': 'Astrup', 'Affiliation': 'Department of Nutrition, Exercise and Sports, Faculty of Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Yishai', 'Initials': 'Y', 'LastName': 'Zohar', 'Affiliation': 'Gelesis, Boston, MA, USA.'}, {'ForeName': 'Lorien E', 'Initials': 'LE', 'LastName': 'Urban', 'Affiliation': 'Gelesis, Boston, MA, USA.'}, {'ForeName': 'R Drew', 'Initials': 'RD', 'LastName': 'Sayer', 'Affiliation': 'University of Colorado Anschutz Medical Campus, Aurora, CO, USA.'}, {'ForeName': 'Bruce W', 'Initials': 'BW', 'LastName': 'Patterson', 'Affiliation': 'Washington University School of Medicine, St. Louis, MO, USA.'}, {'ForeName': 'Sharon J', 'Initials': 'SJ', 'LastName': 'Herring', 'Affiliation': 'Temple University, Philadelphia, PA, USA.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Klein', 'Affiliation': 'Washington University School of Medicine, St. Louis, MO, USA.'}, {'ForeName': 'Babette S', 'Initials': 'BS', 'LastName': 'Zemel', 'Affiliation': 'University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Gary D', 'Initials': 'GD', 'LastName': 'Foster', 'Affiliation': 'University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Holly R', 'Initials': 'HR', 'LastName': 'Wyatt', 'Affiliation': 'University of Colorado Anschutz Medical Campus, Aurora, CO, USA.'}, {'ForeName': 'James O', 'Initials': 'JO', 'LastName': 'Hill', 'Affiliation': 'University of Colorado Anschutz Medical Campus, Aurora, CO, USA.'}]",International journal of obesity (2005),['10.1038/s41366-018-0298-4'] 503,31874153,Effect of Telenursing and Face-to-Face Training Techniques on Quality of Life in Burn Patients: A Clinical Trial.,"OBJECTIVE To compare the effect of telenursing and face-to-face training on the quality of life (QOL) of patients with a burn injury. DESIGN This clinical trial with pretest-posttest design on 3 groups was conducted in Kermanshah, Iran, from 2017 to 2018. Convenience sampling was used. SETTING A tertiary hospital in Kermanshah, west of Iran. PARTICIPANTS A total of 90 patients with burns of grade 2 and 3 after discharge from the hospital were randomly assigned to 3 groups including telenursing (30), face-to-face training (30), and control (30). INTERVENTIONS Each intervention group received 1-on-1 telephone training and face-to-face training in 8 sessions (2 sessions of 15 to 20min/wk). The control group received regular care. MAIN OUTCOME MEASURES QOL was evaluated by the Burn Specific Health Scale-Brief (BSHS-B). RESULTS The mean BSHS-B scores before and after intervention for telenursing, face-to-face, and the control group were 71.43±21.92 and 133.06±11.97; 64.83±26.16 and 124.83±23.05; and 58.63±20.89 and 73.13±33.04, respectively. There was a statistically significant difference among the 3 groups with respect to the training methods after intervention (P<.001). In addition, post hoc test did not show a significant difference between the telenursing and face-to-face groups (P=.244). CONCLUSIONS Educational methods in the form of telenursing and face-to-face training were effective and promoted QOL in survivors of burn injuries. Both telenursing and face-to-face training can be used to improve the QOL of survivors of burn injuries during the rehabilitation phase.",2020,Both telenursing and face-to-face training can be used to improve the quality of life of burn survivors during rehabilitation phase.,"['A total of 90 burn patients with grade 2 and 3 after discharge from hospital', 'burn patients', 'three groups was conducted in Kermanshah (Iran) from 2017 to 2018', 'a tertiary hospital at Kermanshah, west of Iran']","['one-on-one telephone training and face-to-face training', 'tele-nursing and face-to-face training techniques', 'telenursing and face-to-face training', 'face-to-face training (30) and control (30', 'regular care']","['quality of life', 'mean BSHS-B scores', 'Burn Specific Health Scale-Brief (BSHS-B', 'quality of life of burn survivors', 'Quality of life', 'quality of life of burn injured']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0006434', 'cui_str': 'Burns'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0438953', 'cui_str': 'Discharged from hospital (finding)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0587437', 'cui_str': 'Tertiary Hospital'}, {'cui': 'C0022065', 'cui_str': 'Islamic Republic of Iran'}]","[{'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C0028678', 'cui_str': 'nursing care'}, {'cui': 'C0080236', 'cui_str': 'Training Technics'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205272', 'cui_str': 'Regular (qualifier value)'}]","[{'cui': 'C0034380'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0006434', 'cui_str': 'Burns'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0222045'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}]",90.0,0.0248646,Both telenursing and face-to-face training can be used to improve the quality of life of burn survivors during rehabilitation phase.,"[{'ForeName': 'Mohsen', 'Initials': 'M', 'LastName': 'Rezaei', 'Affiliation': 'Nursing Department, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}, {'ForeName': 'Rostam', 'Initials': 'R', 'LastName': 'Jalali', 'Affiliation': 'Department of Nursing, Kermanshah University of Medical Sciences, Kermanshah, Iran. Electronic address: ks_jalali@yahoo.com.'}, {'ForeName': 'Nastaran', 'Initials': 'N', 'LastName': 'Heydarikhayat', 'Affiliation': 'Nursing Department, Iranshahr University of Medical Sciences, Iranshahr, Iran.'}, {'ForeName': 'Nader', 'Initials': 'N', 'LastName': 'Salari', 'Affiliation': 'Biostatistics Department, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}]",Archives of physical medicine and rehabilitation,['10.1016/j.apmr.2019.10.197'] 504,32201122,"A Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy of Steroid Supplementation After Temporomandibular Joint Arthrocentesis.","PURPOSE In patients with unilateral intra-articular temporomandibular joint (TMJ) pain, the efficacy of steroid supplementation compared with placebo after TMJ arthrocentesis was examined in a randomized, double-blind, placebo-controlled clinical trial. PATIENTS AND METHODS Female patients unsuccessfully treated by usual therapy were recruited. After informed consent was obtained, 24 patients were randomly assigned to either the experimental group or placebo group. After local anesthesia, TMJ arthrocentesis, consisting of joint lavage using 100 mL of lactated Ringer solution, was performed by a single investigator. Depending on group assignment, triamcinolone acetonide (steroid) or lactated Ringer solution (placebo) was infused into the superior joint space. Patients, blinded to the procedure, were evaluated at baseline and 2, 6, and 12 weeks after arthrocentesis using a visual analog scale for primary outcome pain measures (pain intensity, pain unpleasantness, and chewing pain). A clinical examination using the Research Diagnostic Criteria for Temporomandibular Disorders was performed at each time point by a separate calibrated, blinded examiner. Data were analyzed using an intention-to-treat model. RESULTS Significant decreases in visual analog scale pain scores over time were found between baseline and the post-arthrocentesis time points for both groups. The steroid group had significantly less chewing pain at 6 and 12 weeks than the placebo group. Mean maximum mandibular openings without pain or with pain were significantly greater at all post-arthrocentesis time points than at baseline in the steroid group, whereas the placebo group had a larger mandibular opening at 6 weeks. At 12 weeks, significantly more patients in the steroid group (75%) had a nearly normal mandibular opening without pain (38 mm) compared with the placebo group (20%). In addition, the proportion of patients with a greater than 50% improvement in chewing pain in the steroid group (90%) was significantly higher than that in the placebo group (<40%). CONCLUSIONS The results of this randomized controlled trial support steroid supplementation after TMJ arthrocentesis to achieve longer-lasting pain management and increased pain-free mandibular mobility.",2020,"Mean maximum mandibular openings without pain or with pain were significantly greater at all post-arthrocentesis time points than at baseline in the steroid group, whereas the placebo group had a larger mandibular opening at 6 weeks.","['24 patients', 'Female patients unsuccessfully treated by usual therapy were recruited', 'patients with unilateral intra-articular temporomandibular joint (TMJ) pain']","['Steroid Supplementation', 'placebo', 'steroid supplementation', 'lactated Ringer solution', 'Placebo', 'triamcinolone acetonide (steroid) or lactated Ringer solution (placebo']","['chewing pain', 'normal mandibular opening without pain', 'Mean maximum mandibular openings without pain or with pain', 'visual analog scale for primary outcome pain measures (pain intensity, pain unpleasantness, and chewing pain', 'visual analog scale pain scores', 'pain-free mandibular mobility']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C0442108', 'cui_str': 'Intra-articular (qualifier value)'}, {'cui': 'C0039493', 'cui_str': 'TMJ'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]","[{'cui': 'C0038317', 'cui_str': 'Steroids'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0073385', 'cui_str': ""Hartmann's Solution""}, {'cui': 'C0040866', 'cui_str': 'Triamcinolone Acetonide'}]","[{'cui': 'C0699816', 'cui_str': 'Does chew (finding)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C2732809', 'cui_str': 'Visual analog scale pain score (observable entity)'}, {'cui': 'C0908489', 'cui_str': 'Pain-Free'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}]",24.0,0.673487,"Mean maximum mandibular openings without pain or with pain were significantly greater at all post-arthrocentesis time points than at baseline in the steroid group, whereas the placebo group had a larger mandibular opening at 6 weeks.","[{'ForeName': 'M Franklin', 'Initials': 'MF', 'LastName': 'Dolwick', 'Affiliation': 'Professor and Academy 100 Eminent Scholar, Department of Oral and Maxillofacial Surgery, College of Dentistry, University of Florida, Gainesville, FL.'}, {'ForeName': 'Daili', 'Initials': 'D', 'LastName': 'Diaz', 'Affiliation': 'Resident, Department of Oral and Maxillofacial Surgery, College of Dentistry, University of Florida, Gainesville, FL.'}, {'ForeName': 'Danielle L', 'Initials': 'DL', 'LastName': 'Freburg-Hoffmeister', 'Affiliation': 'Clinical Assistant Professor, Department of Oral and Maxillofacial Surgery, College of Dentistry, University of Florida, Gainesville, FL.'}, {'ForeName': 'Charles G', 'Initials': 'CG', 'LastName': 'Widmer', 'Affiliation': 'Associate Professor and Parker E. Mahan Facial Pain Endowed Professor, Department of Orthodontics, College of Dentistry, University of Florida, Gainesville, FL. Electronic address: widmer@dental.ufl.edu.'}]",Journal of oral and maxillofacial surgery : official journal of the American Association of Oral and Maxillofacial Surgeons,['10.1016/j.joms.2020.02.022'] 505,31753674,Antibody-dependent cell-mediated cytotoxicity antibody responses to inactivated and live-attenuated influenza vaccination in children during 2014-15.,"BACKGROUND Seasonal influenza vaccines aim to induce strain-specific neutralizing antibodies. Non-neutralizing antibodies may be more broadly cross-reactive and still protect through mechanisms including antibody-dependent cell-mediated cytotoxicity (ADCC). Influenza vaccines may stimulate ADCC antibodies in adults, but whether they do so in children is unknown. Here we examined how vaccination affects cross-reactive ADCC antibody responses in children after receipt of inactivated trivalent vaccine (IIV3) or quadrivalent live-attenuated vaccine (LAIV4). METHODS Children aged 5-17 were recruited in fall 2014 to provide pre- and post-vaccination serum samples. Children aged 5-9 received LAIV4 based on then-current recommendation, and older children were randomly assigned to IIV3 or LAIV4. We used microtiter-plate-based flow cytometry with an NK cell line to examine ADCC antibody responses to the 2014-15 H3N2 vaccine component (A/Texas/50/2012 [TX12]) and a drifted strain, A/Switzerland/9715293/2013 (SW13). Responses were stratified by two-season (2013-14 and 2014-15) vaccine sequence. RESULTS Eighty-five children received LAIV4 and 45 received IIV3. Prevaccination ADCC activity was highest in children who had received any vaccine in the prior season. Increase in ADCC antibody responses against the vaccine strain TX12 following vaccination was greatest for participants who received IIV3 in 2014-15 and LAIV4 in the prior season (geometric mean fold rise [MFR] = 1.6, 95% CI. 1.23-2.11). This group also had a detectable ADCC response to the drifted SW13 strain. There was a modest ADCC response against SW13 in LAIV4 recipients who were unvaccinated in the previous season (MFR = 1.18, 95% CI 1.10-1.25). There were no significant changes in 2014-15 ADCC response to vaccination among children who had received IIV3 in 2013-14. CONCLUSIONS Vaccinating children with IIV3 after prior receipt of LAIV4 generated a modest increase in ADCC antibodies, including some cross-reactivity with an emerging drift variant. Other vaccine-induced ADCC responses were minimal and not affected by vaccine type or sequence.",2020,"Increase in ADCC antibody responses against the vaccine strain TX12 following vaccination was greatest for participants who received IIV3 in 2014-15 and LAIV4 in the prior season (geometric mean fold rise [MFR] = 1.6, 95% CI.","['Children aged 5-9 received LAIV4 based on then-current recommendation, and older children', 'children who had received any vaccine in the prior season', 'children after receipt of', 'Children aged 5-17 were recruited in fall 2014 to provide pre- and post-vaccination serum samples', 'children during 2014-15']","['microtiter-plate-based flow cytometry with an NK cell line', 'IIV3 or LAIV4', 'Influenza vaccines', 'inactivated trivalent vaccine (IIV3) or quadrivalent live-attenuated vaccine (LAIV4', 'drifted strain, A/Switzerland/9715293/2013 (SW13', 'inactivated and live-attenuated influenza vaccination']","['Prevaccination ADCC activity', 'ADCC antibody responses', 'ADCC response against SW13', 'ADCC antibodies', 'ADCC responses', 'detectable ADCC response']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0036497', 'cui_str': 'Seasons'}, {'cui': 'C0000921', 'cui_str': 'Falls'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C1550100', 'cui_str': 'Serum specimen'}]","[{'cui': 'C0407295', 'cui_str': 'Fixation of fracture using plate (procedure)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0016263', 'cui_str': 'Flow Microfluorimetry'}, {'cui': 'C0022688', 'cui_str': 'NK Cells'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0021403', 'cui_str': 'Influenza Vaccines'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0080194', 'cui_str': 'Strains'}, {'cui': 'C3652556', 'cui_str': 'influenza, live attenuated'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]","[{'cui': 'C0003272', 'cui_str': 'ADCC'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0003261', 'cui_str': 'Antibody Response'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}]",85.0,0.0689224,"Increase in ADCC antibody responses against the vaccine strain TX12 following vaccination was greatest for participants who received IIV3 in 2014-15 and LAIV4 in the prior season (geometric mean fold rise [MFR] = 1.6, 95% CI.","[{'ForeName': 'Kelsey', 'Initials': 'K', 'LastName': 'Florek', 'Affiliation': 'Wisconsin State Laboratory of Hygiene, Madison, WI 53714, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Mutschler', 'Affiliation': 'Department of Pathobiological Sciences, University of Wisconsin School of Veterinary Medicine, Madison, WI 53706, USA.'}, {'ForeName': 'Huong Q', 'Initials': 'HQ', 'LastName': 'McLean', 'Affiliation': 'Center for Clinical Epidemiology and Population Health, Marshfield Clinic Research Institute, 1000 North Oak Ave, Marshfield 54449, WI, USA.'}, {'ForeName': 'Jennifer P', 'Initials': 'JP', 'LastName': 'King', 'Affiliation': 'Center for Clinical Epidemiology and Population Health, Marshfield Clinic Research Institute, 1000 North Oak Ave, Marshfield 54449, WI, USA.'}, {'ForeName': 'Brendan', 'Initials': 'B', 'LastName': 'Flannery', 'Affiliation': 'Centers for Disease Control and Prevention, 1600 Clifton Rd, Atlanta 30333, GA, USA.'}, {'ForeName': 'Edward A', 'Initials': 'EA', 'LastName': 'Belongia', 'Affiliation': 'Center for Clinical Epidemiology and Population Health, Marshfield Clinic Research Institute, 1000 North Oak Ave, Marshfield 54449, WI, USA. Electronic address: belongia.edward@marshfieldclinic.org.'}, {'ForeName': 'Thomas C', 'Initials': 'TC', 'LastName': 'Friedrich', 'Affiliation': 'Department of Pathobiological Sciences, University of Wisconsin School of Veterinary Medicine, Madison, WI 53706, USA; Wisconsin National Primate Research Center, Madison, WI 53715, USA. Electronic address: thomasf@primate.wisc.edu.'}]",Vaccine,['10.1016/j.vaccine.2019.10.060'] 506,32103160,Oral dextrose reduced procedural pain without altering cellular ATP metabolism in preterm neonates: a prospective randomized trial.,"OBJECTIVE To examine the effects of 30% oral dextrose on biochemical markers of pain, adenosine triphosphate (ATP) degradation, and oxidative stress in preterm neonates experiencing a clinically required heel lance. STUDY DESIGN Utilizing a prospective study design, preterm neonates that met study criteria (n = 169) were randomized to receive either (1) 30% oral dextrose, (2) facilitated tucking, or (3) 30% oral dextrose and facilitated tucking 2 min before heel lance. Plasma markers of ATP degradation (hypoxanthine, uric acid) and oxidative stress (allantoin) were measured before and after the heel lance. Pain was measured using the premature infant pain profile-revised (PIPP-R). RESULTS Oral dextrose, administered alone or with facilitated tucking, did not alter plasma markers of ATP utilization and oxidative stress. CONCLUSION A single dose of 30% oral dextrose, given before a clinically required heel lance, decreased signs of pain without increasing ATP utilization and oxidative stress in premature neonates.",2020,"Plasma markers of ATP degradation (hypoxanthine, uric acid) and oxidative stress (allantoin) were measured before and after the heel lance.","['preterm neonates that met study criteria (n\u2009=\u2009169', 'premature neonates', 'preterm neonates', 'preterm neonates experiencing a clinically required heel lance']","['Oral dextrose', 'oral dextrose, (2) facilitated tucking, or (3) 30% oral dextrose and facilitated tucking 2\u2009min before heel lance', '30% oral dextrose']","['premature infant pain profile-revised (PIPP-R', 'plasma markers of ATP utilization and oxidative stress', 'biochemical markers of pain, adenosine triphosphate (ATP) degradation, and oxidative stress', 'Pain', 'procedural pain', 'Plasma markers of ATP degradation (hypoxanthine, uric acid) and oxidative stress (allantoin']","[{'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0205252', 'cui_str': 'Immature (qualifier value)'}, {'cui': 'C0018870', 'cui_str': 'Heel'}, {'cui': 'C0522666', 'cui_str': 'Lance, device (physical object)'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0017725', 'cui_str': 'dextrose'}, {'cui': 'C3179031', 'cui_str': 'Facilitated Tucking'}, {'cui': 'C0185026', 'cui_str': 'Plication - action (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0018870', 'cui_str': 'Heel'}, {'cui': 'C0522666', 'cui_str': 'Lance, device (physical object)'}]","[{'cui': 'C4048294', 'cui_str': 'Preterm Infant'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0001480', 'cui_str': 'ATP'}, {'cui': 'C0042153', 'cui_str': 'use'}, {'cui': 'C0242606', 'cui_str': 'Oxidative Stress'}, {'cui': 'C0206015', 'cui_str': 'Biochemical Marker'}, {'cui': 'C0243125', 'cui_str': 'degradation'}, {'cui': 'C1619712', 'cui_str': 'Pain, Procedural'}, {'cui': 'C0020684', 'cui_str': 'Hypoxanthine'}, {'cui': 'C0041980', 'cui_str': 'Uric Acid'}, {'cui': 'C0002083', 'cui_str': 'Allantoin'}]",169.0,0.263784,"Plasma markers of ATP degradation (hypoxanthine, uric acid) and oxidative stress (allantoin) were measured before and after the heel lance.","[{'ForeName': 'Danilyn M', 'Initials': 'DM', 'LastName': 'Angeles', 'Affiliation': 'Department of Basic Sciences, School of Medicine, Loma Linda University, Loma Linda, CA, USA. dangeles@llu.edu.'}, {'ForeName': 'Danilo S', 'Initials': 'DS', 'LastName': 'Boskovic', 'Affiliation': 'Department of Basic Sciences, School of Medicine, Loma Linda University, Loma Linda, CA, USA.'}, {'ForeName': 'John C', 'Initials': 'JC', 'LastName': 'Tan', 'Affiliation': 'Department of Basic Sciences, School of Medicine, Loma Linda University, Loma Linda, CA, USA.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Shih', 'Affiliation': 'School of Public Health, Loma Linda Univeristy, Loma Linda, CA, USA.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Hoch', 'Affiliation': ""Loma Linda University Children's Hospital, Loma Linda, CA, USA.""}, {'ForeName': 'Dorothy', 'Initials': 'D', 'LastName': 'Forde', 'Affiliation': 'School of Nursing, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Raylene M', 'Initials': 'RM', 'LastName': 'Phillips', 'Affiliation': 'Department of Pediatrics, School of Medicine, Loma Linda University, Loma Linda, CA, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Hopper', 'Affiliation': 'Department of Pediatrics, School of Medicine, Loma Linda University, Loma Linda, CA, USA.'}, {'ForeName': 'Douglas D', 'Initials': 'DD', 'LastName': 'Deming', 'Affiliation': 'Department of Pediatrics, School of Medicine, Loma Linda University, Loma Linda, CA, USA.'}, {'ForeName': 'Mitchell', 'Initials': 'M', 'LastName': 'Goldstein', 'Affiliation': 'Department of Pediatrics, School of Medicine, Loma Linda University, Loma Linda, CA, USA.'}, {'ForeName': 'Giang', 'Initials': 'G', 'LastName': 'Truong', 'Affiliation': 'Department of Pediatrics, School of Medicine, Loma Linda University, Loma Linda, CA, USA.'}, {'ForeName': 'Aprille', 'Initials': 'A', 'LastName': 'Febre', 'Affiliation': 'Department of Pediatrics, School of Medicine, Loma Linda University, Loma Linda, CA, USA.'}, {'ForeName': 'Priscilla', 'Initials': 'P', 'LastName': 'Pegis', 'Affiliation': ""Loma Linda University Children's Hospital, Loma Linda, CA, USA.""}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Lavery', 'Affiliation': 'Department of Pediatrics, School of Medicine, Loma Linda University, Loma Linda, CA, USA.'}, {'ForeName': 'Munaf', 'Initials': 'M', 'LastName': 'Kadri', 'Affiliation': 'Department of Pediatrics, School of Medicine, Loma Linda University, Loma Linda, CA, USA.'}, {'ForeName': 'Anamika', 'Initials': 'A', 'LastName': 'Banerji', 'Affiliation': 'Department of Pediatrics, School of Medicine, Loma Linda University, Loma Linda, CA, USA.'}, {'ForeName': 'Iman', 'Initials': 'I', 'LastName': 'Mousselli', 'Affiliation': 'Department of Basic Sciences, School of Medicine, Loma Linda University, Loma Linda, CA, USA.'}, {'ForeName': 'Vora', 'Initials': 'V', 'LastName': 'Farha', 'Affiliation': 'Department of Pediatrics, School of Medicine, Loma Linda University, Loma Linda, CA, USA.'}, {'ForeName': 'Elba', 'Initials': 'E', 'LastName': 'Fayard', 'Affiliation': 'Department of Pediatrics, School of Medicine, Loma Linda University, Loma Linda, CA, USA.'}]",Journal of perinatology : official journal of the California Perinatal Association,['10.1038/s41372-020-0634-0'] 507,32149451,"Emergency Potassium Normalization Treatment Including Sodium Zirconium Cyclosilicate: A Phase II, Randomized, Double-blind, Placebo-controlled Study (ENERGIZE).","OBJECTIVES Sodium zirconium cyclosilicate (SZC) is a novel, highly selective potassium binder currently approved in the United States and European Union for treatment of hyperkalemia. This pilot evaluation explored the efficacy of SZC with insulin and glucose as hyperkalemia treatment in the emergency department (ED). METHODS This exploratory, phase II, multicenter, randomized, double-blind, placebo-controlled study (NCT03337477) enrolled adult ED patients with blood potassium ≥ 5.8 mmol/L. Patients were randomized 1:1 to receive SZC 10 g or placebo, up to three times during a 10-hour period, with insulin and glucose. The primary efficacy outcome was the mean change in serum potassium (sK + ) from baseline until 4 hours after start of dosing. RESULTS Overall, 70 patients were randomized (SZC n = 33, placebo n = 37), of whom 50.0% were male. Their mean (± standard deviation [±SD]) age was 59.0 (±13.8) years and mean initial sK + was similar between groups (SZC 6.4 mmol/L, placebo 6.5 mmol/L). The least squares mean (±SD) sK + change from baseline to 4 hours was -0.41 (±0.11) mmol/L and -0.27 (±0.10) mmol/L with SZC and placebo, respectively (difference = -0.13 mmol/L, 95% confidence interval [CI] = -0.44 to 0.17). A greater reduction in mean (±SD) sK + from baseline occurred with SZC compared with placebo at 2 hours: -0.72 (±0.12) versus -0.36 (±0.11) mmol/L (LSM difference = -0.35 mmol/L, 95% CI = -0.68 to -0.02), respectively. A numerically lower proportion of patients in the SZC group required additional potassium-lowering therapy due to hyperkalemia at 0 to 4 hours versus placebo (15.6% vs. 30.6%, respectively; odds ratio = 0.40, 95% CI = 0.09 to 1.77). Comparable proportions of patients experienced adverse events in both treatment groups at 0 to 24 hours. CONCLUSIONS This pilot study suggested that SZC with insulin and glucose may provide an incremental benefit in the emergency treatment of hyperkalemia over insulin and glucose alone.",2020,A greater reduction in mean sK + from baseline occurred with SZC compared with placebo at 2 hours: -0.72 (0.12) versus -0.36,"['enrolled adult ED patients with blood potassium', '70 patients were randomized (SZC n = 33; placebo n = 37), of which 50.0% were male']","['SZC 10 g or placebo', 'Emergency Potassium Normalization Treatment Including Sodium Zirconium Cyclosilicate', 'SZC with insulin and glucose', 'placebo', 'Sodium zirconium cyclosilicate (SZC', 'SZC and placebo', 'Placebo']","['adverse events', 'additional potassium-lowering therapy due to hyperkalemia', 'mean change in serum potassium (sK + ', 'mean sK ', 'least squares mean (SD) sK + change']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0853173', 'cui_str': 'Blood potassium'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0086582', 'cui_str': 'Males'}]","[{'cui': 'C1318182', 'cui_str': '10G'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0175673', 'cui_str': 'Emergency (qualifier value)'}, {'cui': 'C0304475', 'cui_str': 'Potassium supplement'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C4045824', 'cui_str': 'sodium zirconium cyclosilicate'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0304475', 'cui_str': 'Potassium supplement'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0020461', 'cui_str': 'Hyperpotassemia'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0302353', 'cui_str': 'Serum potassium measurement'}, {'cui': 'C0023189', 'cui_str': 'Least Squares'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]",70.0,0.712986,A greater reduction in mean sK + from baseline occurred with SZC compared with placebo at 2 hours: -0.72 (0.12) versus -0.36,"[{'ForeName': 'W Frank', 'Initials': 'WF', 'LastName': 'Peacock', 'Affiliation': 'From the, Baylor College of Medicine, Ben Taub General Hospital, Houston, TX.'}, {'ForeName': 'Zubaid', 'Initials': 'Z', 'LastName': 'Rafique', 'Affiliation': 'From the, Baylor College of Medicine, Ben Taub General Hospital, Houston, TX.'}, {'ForeName': 'Konstantin', 'Initials': 'K', 'LastName': 'Vishnevskiy', 'Affiliation': 'the, First Pavlov State, Medical University of St. Petersburg, St. Petersburg, Russia.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Michelson', 'Affiliation': 'the, Department of Emergency Medicine, Texas Tech University Health Sciences Center, El Paso, TX.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Vishneva', 'Affiliation': ""the, Scientific Centre of Children's Health, Russian Academy of Medical Science, Moscow, Russia.""}, {'ForeName': 'Tatiana', 'Initials': 'T', 'LastName': 'Zvereva', 'Affiliation': 'the, Scientific Research Institution for Complex Issues of Cardiovascular Disease, Kemerovo Medical University, Kemerovo, Russia.'}, {'ForeName': 'Rajaa', 'Initials': 'R', 'LastName': 'Nahra', 'Affiliation': 'AstraZeneca, Gaithersburg, MD.'}, {'ForeName': 'Dao', 'Initials': 'D', 'LastName': 'Li', 'Affiliation': 'AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Miller', 'Affiliation': 'and the, Department of Emergency Medicine, Henry Ford Hospital, Detroit, MI.'}]",Academic emergency medicine : official journal of the Society for Academic Emergency Medicine,['10.1111/acem.13954'] 508,32216143,"Effects of Narrative Exposure Therapy on Posttraumatic Stress Disorder, Depression, and Insomnia in Traumatized North Korean Refugee Youth.","Refugees affected by multiple traumatic stressors are at high risk for developing trauma-related mental disorders, including posttraumatic stress disorder (PTSD), depression, and insomnia, which is sometimes overlooked. The present study examined the effectiveness of narrative exposure therapy (NET) on trauma-related symptoms in a sample of North Korean refugee youth. We focused on sleep patterns in addition to changes in symptom severity for PTSD, depression, and internalizing and externalizing symptoms. North Korean refugee youth (N = 20) with PTSD were assigned to either an NET-based treatment group or a control group, which consisted of treatment as usual (TAU). There were clinically significant reductions in PTSD, depression, and internalizing and externalizing symptoms for the NET group, Hedges' g = 3.6, but not the TAU group. The change in diagnostic status for PTSD was more notable for participants in the NET group compared to the TAU group. Of note, NET also produced a significant improvement in insomnia symptoms and sleep quality, Hedges' g = 2.1. The substantial recovery regarding overall posttraumatic symptoms in the NET group was observed 2 weeks after the end of treatment and remained stable at 6-month follow-up. The results of the present study suggest that NET may be a treatment option for traumatized North Korean refugee youth and may also be effective for the treatment of sleep problems that arise from traumatic experiences.",2020,"There were clinically significant reductions in PTSD, depression, and internalizing and externalizing symptoms for the NET group, Hedges' g = 3.6, but not the TAU group.","['Traumatized North Korean Refugee Youth', 'trauma-related symptoms in a sample of North Korean refugee youth', 'North Korean refugee youth (N = 20) with PTSD']","['NET', 'narrative exposure therapy (NET', 'NET-based treatment group or a control group, which consisted of treatment as usual (TAU', 'Narrative Exposure Therapy']","['symptom severity for PTSD, depression, and internalizing and externalizing symptoms', 'diagnostic status for PTSD', 'PTSD, depression, and internalizing and externalizing symptoms', 'Posttraumatic Stress Disorder, Depression, and Insomnia', 'overall posttraumatic symptoms', 'insomnia symptoms and sleep quality']","[{'cui': 'C1556095', 'cui_str': 'Koreans'}, {'cui': 'C0034961', 'cui_str': 'Refugees'}, {'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0043251', 'cui_str': 'Trauma'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}]","[{'cui': 'C0870527', 'cui_str': 'Exposure Therapy'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1720655', 'cui_str': 'Tau'}]","[{'cui': 'C1319166', 'cui_str': 'Symptom severity (finding)'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0348026', 'cui_str': 'Diagnostic'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}]",20.0,0.0228226,"There were clinically significant reductions in PTSD, depression, and internalizing and externalizing symptoms for the NET group, Hedges' g = 3.6, but not the TAU group.","[{'ForeName': 'Jinme K', 'Initials': 'JK', 'LastName': 'Park', 'Affiliation': 'Department of Psychology, University of Konstanz, Konstanz, Germany.'}, {'ForeName': 'Jinah', 'Initials': 'J', 'LastName': 'Park', 'Affiliation': 'Department of Counseling, Kyonggy University, Suwon, Republic of Korea.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Elbert', 'Affiliation': 'Department of Psychology, University of Konstanz, Konstanz, Germany.'}, {'ForeName': 'Seog Ju', 'Initials': 'SJ', 'LastName': 'Kim', 'Affiliation': 'Department of Psychiatry, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.'}]",Journal of traumatic stress,['10.1002/jts.22492'] 509,32219557,"Efficacy and safety of incobotulinumtoxinA in post-stroke upper-limb spasticity in Japanese subjects: results from a randomized, double-blind, placebo-controlled study (J-PURE).","BACKGROUND Upper-limb spasticity frequently occurs after stroke and there is a clinical need for more effective therapies. The Phase III J-PURE study assessed the efficacy and safety of incobotulinumtoxinA up to 400 U for post-stroke upper-limb spasticity in Japan. METHODS In the 12-week main period (MP) of this double-blind, placebo-controlled study, Japanese subjects with upper-limb spasticity received one injection cycle of incobotulinumtoxinA 400 U, 250 U, or matching placebo. Eligible subjects enrolled in an open-label extension (OLEX) period of three injection cycles of incobotulinumtoxinA 400 U (32-40 weeks). The primary objective was to establish the efficacy of a single incobotulinumtoxinA injection using the Modified Ashworth Scale (MAS) wrist score. Secondary efficacy outcomes and safety were also assessed. RESULTS Among 100 treated subjects, AUCs for incobotulinumtoxinA 400 and 250 U were significantly different versus placebo (p = 0.0014 and p = 0.0031, respectively) for change from baseline in MAS wrist score to the end of the MP, with similar results from baseline to week 4. IncobotulinumtoxinA 400 U was superior versus placebo across other spasticity patterns and at most study visits. Improvements were maintained throughout the OLEX period. Disability Assessment Scale and Investigator's Clinical Global Impression scores improved significantly for incobotulinumtoxinA 400 U versus placebo from baseline to week 4 (p = 0.0067 and p < 0.0001, respectively). IncobotulinumtoxinA was well tolerated up to 52 weeks, with no unexpected adverse events. CONCLUSION IncobotulinumtoxinA reduced (pathologically) increased muscle tone, improved functionality and was well tolerated in Japanese subjects with post-stroke upper-limb spasticity.",2020,"Disability Assessment Scale and Investigator's Clinical Global Impression scores improved significantly for incobotulinumtoxinA 400 U versus placebo from baseline to week 4 (p = 0.0067 and p < 0.0001, respectively).","['Eligible subjects enrolled in an open-label extension (OLEX) period of three injection cycles of incobotulinumtoxinA 400 U (32-40\xa0weeks', 'Japanese subjects with post-stroke upper-limb spasticity', 'Japanese subjects', 'Japan', 'Japanese subjects with upper-limb spasticity']","['incobotulinumtoxinA', 'single incobotulinumtoxinA injection', 'placebo', 'IncobotulinumtoxinA 400 U was superior versus placebo', 'IncobotulinumtoxinA', 'incobotulinumtoxinA 400 U, 250 U, or matching placebo']","['Efficacy and safety', 'efficacy and safety', 'Modified Ashworth Scale (MAS) wrist score', 'muscle tone, improved functionality and was well tolerated', 'MAS wrist score', ""Disability Assessment Scale and Investigator's Clinical Global Impression scores""]","[{'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C2930113', 'cui_str': 'incobotulinumtoxinA'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C1273957', 'cui_str': 'Upper limb spasticity'}, {'cui': 'C0022341', 'cui_str': 'Japan'}]","[{'cui': 'C2930113', 'cui_str': 'incobotulinumtoxinA'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0336766', 'cui_str': 'Matches'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C4707572', 'cui_str': 'Modified Ashworth Scale (assessment scale)'}, {'cui': 'C0043262', 'cui_str': 'Wrist'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0549465', 'cui_str': 'Muscle tone (observable entity)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C3854497', 'cui_str': 'Disability assessment scale'}, {'cui': 'C0035173', 'cui_str': 'Investigators'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}]",,0.358522,"Disability Assessment Scale and Investigator's Clinical Global Impression scores improved significantly for incobotulinumtoxinA 400 U versus placebo from baseline to week 4 (p = 0.0067 and p < 0.0001, respectively).","[{'ForeName': 'Yoshihisa', 'Initials': 'Y', 'LastName': 'Masakado', 'Affiliation': 'Department of Rehabilitation Medicine, Tokai University School of Medicine, Kanagawa, Japan.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Abo', 'Affiliation': 'Department of Rehabilitation Medicine, The Jikei University Hospital, Tokyo, Japan.'}, {'ForeName': 'Kunitsugu', 'Initials': 'K', 'LastName': 'Kondo', 'Affiliation': 'Department of Rehabilitation Medicine, Tokyo Bay Rehabilitation Hospital, Chiba, Japan.'}, {'ForeName': 'Satoru', 'Initials': 'S', 'LastName': 'Saeki', 'Affiliation': 'Department of Rehabilitation Medicine, Hospital of the University of Occupational and Environmental Health, Fukuoka, Japan.'}, {'ForeName': 'Eiichi', 'Initials': 'E', 'LastName': 'Saitoh', 'Affiliation': 'Department of Rehabilitation Medicine I, School of Medicine, Fujita Health University, Aichi, Japan.'}, {'ForeName': 'Andrzej', 'Initials': 'A', 'LastName': 'Dekundy', 'Affiliation': 'Merz Pharmaceuticals GmbH, Frankfurt am Main, Germany.'}, {'ForeName': 'Angelika', 'Initials': 'A', 'LastName': 'Hanschmann', 'Affiliation': 'Merz Pharmaceuticals GmbH, Frankfurt am Main, Germany.'}, {'ForeName': 'Ryuji', 'Initials': 'R', 'LastName': 'Kaji', 'Affiliation': 'Department of Neurology, Tokushima University Hospital, Tokushima City, Tokushima, Japan. rkaji@tokushima-u.ac.jp.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of neurology,['10.1007/s00415-020-09777-5'] 510,32093664,A quasi-experiment assessing the six-months effects of a nurse care coordination program on patient care experiences and clinician teamwork in community health centers.,"BACKGROUND Recognition that coordination among healthcare providers is associated with better quality of care and lower costs has increased interest in interventions designed to improve care coordination. One intervention is to add care coordination to nurses' role in a formal way. Little is known about effects of this approach, which tends to be pursued by small organizations and those in lower-resource settings. We assessed effects of this approach on care experiences of high-risk patients (those most in need of care coordination) and clinician teamwork during the first 6 months of use. METHODS We conducted a quasi-experimental study using a clustered, controlled pre-post design. Changes in staff and patient experiences at six community health center practice locations that introduced the added-role approach for high-risk patients were compared to changes in six locations without the program in the same health system. In the pre-period (6 months before intervention training) and post-period (about 6 months after intervention launch, following 3 months of training), we surveyed clinical staff (N = 171) and program-qualifying patients (3007 pre-period; 2101 post-period, including 113 who were enrolled during the program's first 6 months). Difference-in-differences models examined study outcomes: patient reports about care experiences and clinician-reported teamwork. We assessed frequency of patient office visits to validate access and implementation, and contextual factors (training, resources, and compatibility with other work) that might explain results. RESULTS Patient care experiences across all high-risk patients did not improve significantly (p > 0.05). They improved somewhat for program enrollees, 5% above baseline reports (p = 0.07). Staff-perceived teamwork did not change significantly (p = 0.12). Office visits increased significantly for enrolled patients (p < 0.001), affirming program implementation (greater accessing of care). Contextual factors were not reported as problematic, except that 41% of nurses reported incompatibility between care coordination and other job demands. Over 75% of nurses reported adequate training and resources. CONCLUSIONS There were some positive effects of adding care coordination to nurses' role within 6 months of implementation, suggesting value in this improvement strategy. Addressing compatibility between coordination and other job demands is important when implementing this approach to coordination.",2020,"Office visits increased significantly for enrolled patients (p < 0.001), affirming program implementation (greater accessing of care).",['patient care experiences and clinician teamwork in community health centers'],['nurse care coordination program'],['Office visits'],"[{'cui': 'C0017313'}, {'cui': 'C0009469', 'cui_str': 'Satellite Centers'}]","[{'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0242414', 'cui_str': 'Coordination (observable entity)'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0028900', 'cui_str': 'Office Visits'}]",,0.018514,"Office visits increased significantly for enrolled patients (p < 0.001), affirming program implementation (greater accessing of care).","[{'ForeName': 'Ingrid M', 'Initials': 'IM', 'LastName': 'Nembhard', 'Affiliation': 'The Wharton School, University of Pennsylvania, Health Care Management Department, 3641 Locust Walk, 207 Colonial Penn Center, Philadelphia, PA, 19104, USA. ingridn@wharton.upenn.edu.'}, {'ForeName': 'Eugenia', 'Initials': 'E', 'LastName': 'Buta', 'Affiliation': 'Yale Center for Analytical Sciences (YCAS), 300 George Street, Suite 555, New Haven, CT, 06519, USA.'}, {'ForeName': 'Yuna S H', 'Initials': 'YSH', 'LastName': 'Lee', 'Affiliation': 'Columbia University Mailman School of Public Health, Department of Health Policy & Management, 722 West 168th Street, R476, New York, NY, 10032, USA.'}, {'ForeName': 'Daren', 'Initials': 'D', 'LastName': 'Anderson', 'Affiliation': 'Weitzman Institute, Community Health Center, Inc., 631 Main St., Middletown, CT, 06457, USA.'}, {'ForeName': 'Ianita', 'Initials': 'I', 'LastName': 'Zlateva', 'Affiliation': 'Weitzman Institute, Community Health Center, Inc., 631 Main St., Middletown, CT, 06457, USA.'}, {'ForeName': 'Paul D', 'Initials': 'PD', 'LastName': 'Cleary', 'Affiliation': 'Yale School of Public Health, 60 College St., P.O. Box 208034, New Haven, CT, 06520-8034, USA.'}]",BMC health services research,['10.1186/s12913-020-4986-0'] 511,30776911,Ancillary service needs among persons new to HIV care and the relationship between needs and late presentation to care.,"Ancillary service needs likely influence time to diagnosis and presentation for HIV care. The effect of both met and unmet needs on late presentation to HIV care is not well understood. We used baseline data from 348 people with HIV (PWH) with no prior HIV care who enrolled in iENGAGE (a randomized controlled trial (RCT) of an intervention to support retention in care) at one of four HIV clinics in the US. A standardized baseline questionnaire collected information on ancillary service needs, and whether each need was presently unmet. We examined covariates known to be associated with disease stage at presentation to care and their association with needs. We subsequently assessed the relationship of needs with CD4 accounting for those other covariates by estimating prevalence ratios (PR) using inverse probability weights. Most patients enrolling in the RCT were male (79%) and the majority were Black (62%); median age was 34 years. Prevalence of any reported individual need was 69%. One-third of the sample had a baseline CD4 cell count <200, 42% between 200 and 499 and 27% ≥500. There was no statistically significant association between need or unmet need and baseline CD4. In general, psychiatric health and SU issues (depression, anxiety, and drug use) were consistently associated with higher prevalence of need (met and unmet). Additionally, the Black race was associated with higher basic resource needs (housing: PR 1.67, 95%CI 1.08-2.59; transportation: PR 1.65, 95% CI 1.12-2.45). Ancillary service needs (met and unmet) were common among patients new to HIV care and impacted vulnerable subgroups. However, we found no evidence that reporting a specific individual need, whether met or unmet, was associated with a timely presentation to HIV care. The impact of needs on subsequent steps of the HIV care continuum will be examined with longitudinal data.",2019,"Additionally, the Black race was associated with higher basic resource needs (housing: PR 1.67, 95%CI 1.08-2.59; transportation: PR 1.65, 95% CI 1.12-2.45).","['348 people with HIV (PWH) with no prior HIV care who enrolled', 'Most patients enrolling in the RCT were male (79%) and the majority were Black (62%); median age was 34 years']",[],['baseline CD4 cell count'],"[{'cui': 'C4517733', 'cui_str': '348'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]",[],"[{'cui': 'C0243009', 'cui_str': 'CD4+ Counts'}]",,0.135374,"Additionally, the Black race was associated with higher basic resource needs (housing: PR 1.67, 95%CI 1.08-2.59; transportation: PR 1.65, 95% CI 1.12-2.45).","[{'ForeName': 'Anne K', 'Initials': 'AK', 'LastName': 'Monroe', 'Affiliation': 'a Johns Hopkins University School of Medicine , Baltimore , MD , USA.'}, {'ForeName': 'Catherine R', 'Initials': 'CR', 'LastName': 'Lesko', 'Affiliation': 'c Johns Hopkins Bloomberg School of Public Health , Baltimore , MD , USA.'}, {'ForeName': 'Geetanjali', 'Initials': 'G', 'LastName': 'Chander', 'Affiliation': 'a Johns Hopkins University School of Medicine , Baltimore , MD , USA.'}, {'ForeName': 'Bryan', 'Initials': 'B', 'LastName': 'Lau', 'Affiliation': 'c Johns Hopkins Bloomberg School of Public Health , Baltimore , MD , USA.'}, {'ForeName': 'Jeanne', 'Initials': 'J', 'LastName': 'Keruly', 'Affiliation': 'd Adult Ryan White Services , Johns Hopkins University , Baltimore , MD , USA.'}, {'ForeName': 'Heidi M', 'Initials': 'HM', 'LastName': 'Crane', 'Affiliation': 'e Harborview Medical Center , University of Washington , Seattle , WA , USA.'}, {'ForeName': 'K Rivet', 'Initials': 'KR', 'LastName': 'Amico', 'Affiliation': 'f Department of Health Behavior and Health Education , School of Public Health, University of Michigan , Ann Arbor , MI , USA.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Napravnik', 'Affiliation': 'g School of Medicine , Chapel Hill , NC , USA.'}, {'ForeName': 'E Byrd', 'Initials': 'EB', 'LastName': 'Quinlivan', 'Affiliation': 'h Institute for Global Health and Infectious Diseases , University of North Carolina at Chapel Hill , Chapel Hill , NC , USA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Mugavero', 'Affiliation': 'i Division of Infectious Diseases , University of Alabama at Birmingham (UAB) , Birmingham , AL , USA.'}]",AIDS care,['10.1080/09540121.2019.1576840'] 512,30783259,Oral fluoxetine in the management of amblyopic patients aged between 10 and 40 years old: a randomized clinical trial.,"OBJECTIVE The objective of this study is to assess the efficacy of oral fluoxetine therapy in improving the visual function of amblyopic patients aged between 10 and 40 years old. METHODS In this double-blinded, randomized, controlled trial (IRCT2016052428046N1; registered retrospectively), 40 eligible participants with anisometropic or mixed amblyopia were randomly assigned to either fluoxetine or placebo groups. Participants with anisometropia and logMAR best spectacle-corrected visual acuity (BSCVA) worse than 0.2 logMAR in the amblyopic eye or at least a two-line of difference in the BSCVA between the fellow eyes were included. Participants with significant ocular or systemic diseases were excluded. In both groups, the better eye of each patient was patched for 4-6 h a day during the study period. Participants in the treatment group were treated with oral fluoxetine for 3 months. Change in the Snellen BSCVA (after 3 months) was regarded as the primary outcome measure. RESULTS Data from 20 participants in the fluoxetine group and 15 participants from the placebo group were analyzed (aged 11-37 years). The magnitude of improvement in visual acuity (from baseline to 3 months after treatment) was significantly higher in the fluoxetine group (0.240 ± 0.068 logMAR; 2.4 line-gain) compared with the control group (0.120 ± 0.086 logMAR; 1.2 line-gain). CONCLUSIONS This study suggests beneficial effects of fluoxetine in the management of adult and adolescent amblyopia.",2019,"The magnitude of improvement in visual acuity (from baseline to 3 months after treatment) was significantly higher in the fluoxetine group (0.240 ± 0.068 logMAR; 2.4 line-gain) compared with the control group (0.120 ± 0.086 logMAR; 1.2 line-gain). ","['amblyopic patients aged between 10 and 40 years old', '40 eligible participants with anisometropic or mixed amblyopia', 'adult and adolescent amblyopia', 'Participants with significant ocular or systemic diseases were excluded', '20 participants in the fluoxetine group and 15 participants from the placebo group were analyzed (aged 11-37 years']","['oral fluoxetine', 'fluoxetine', 'Oral fluoxetine', 'fluoxetine therapy', 'fluoxetine or placebo']","['anisometropia and logMAR best spectacle-corrected visual acuity (BSCVA', 'visual acuity']","[{'cui': 'C0002418', 'cui_str': 'Amblyopia'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C4521296', 'cui_str': 'Ocular (intended site)'}, {'cui': 'C0442893', 'cui_str': 'Systemic illness (qualifier value)'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0016365', 'cui_str': 'Fluoxetine'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0016365', 'cui_str': 'Fluoxetine'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0003081', 'cui_str': 'Anisometropia'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0015421', 'cui_str': 'Glasses'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity (observable entity)'}, {'cui': 'C0042812', 'cui_str': 'Visual Acuity'}]",40.0,0.22094,"The magnitude of improvement in visual acuity (from baseline to 3 months after treatment) was significantly higher in the fluoxetine group (0.240 ± 0.068 logMAR; 2.4 line-gain) compared with the control group (0.120 ± 0.086 logMAR; 1.2 line-gain). ","[{'ForeName': 'Mohammad Hossein', 'Initials': 'MH', 'LastName': 'Sharif', 'Affiliation': 'Department of Physiology, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Mohammad Reza', 'Initials': 'MR', 'LastName': 'Talebnejad', 'Affiliation': 'Poostchi Ophthalmology Research Center, Department of Ophthalmology, Shiraz University of Medical Sciences, Shiraz, Iran. talebnejadmr@yahoo.com.'}, {'ForeName': 'Karim', 'Initials': 'K', 'LastName': 'Rastegar', 'Affiliation': 'Department of Physiology, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Mohammad Reza', 'Initials': 'MR', 'LastName': 'Khalili', 'Affiliation': 'Poostchi Ophthalmology Research Center, Department of Ophthalmology, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'M Hossein', 'Initials': 'MH', 'LastName': 'Nowroozzadeh', 'Affiliation': 'Poostchi Ophthalmology Research Center, Department of Ophthalmology, Shiraz University of Medical Sciences, Shiraz, Iran.'}]","Eye (London, England)",['10.1038/s41433-019-0360-z'] 513,31125086,Impact of window views on recovery-an example of post-cesarean section women.,"OBJECTIVE The objective of this study was to examine the impact of urban landscape from window views on quality of care for women who underwent Cesarean Section (C-section) in Taiwan. DESIGN The participants were randomly assigned into 46 different hospital rooms to see the effects of various window views and daylight exposure on women's recovery from post C-section care. SETTING We carried out this study in the obstetrics departments of three tertiary hospitals located in two major cities of Taiwan: Taipei City and New Taipei City. PARTICIPANTS A total of 296 women who underwent C-sections and used patient-controlled analgesic (PCA) for pain control after their surgery during the 10-month data collection period were recruited for this study. INTERVENTION The 46 different patient rooms provided diverse window views and different daylight exposure for the participants. MAIN OUTCOME MEASURES Recovery for the women who underwent C-sections in this study was defined as PCA usage and perceived pain measured by Brief Pain Inventory (BFI). RESULTS Higher satisfaction of window view significantly decreased analgesic usage (P = 0.057), reduced the scores of overall perceived pain (P = 0.046), pain severity (P = 0.004), and 'pain's interference with relations with others, enjoyment of life, and mood (REM).' (P = 0.095). CONCLUSIONS To maximize benefit and well-being of patients recovering from surgery, health care architects should design patient rooms to create maximum satisfaction with visual impacts and optimize window views. By doing so, it may decrease the use of pain medication and substantially reduce healthcare costs.",2019,"RESULTS Higher satisfaction of window view significantly decreased analgesic usage (P = 0.057), reduced the scores of overall perceived pain (P = 0.046), pain severity (P = 0.004), and 'pain's interference with relations with others, enjoyment of life, and mood (REM).'","['post-cesarean section women', 'A total of 296 women who underwent C-sections and used patient-controlled analgesic (PCA) for pain control after their surgery during the 10-month data collection period were recruited for this study', 'obstetrics departments of three tertiary hospitals located in two major cities of Taiwan: Taipei City and New Taipei City', 'women who underwent Cesarean Section (C-section) in Taiwan']","[""various window views and daylight exposure on women's recovery from post C-section care"", 'urban landscape from window views']","['PCA usage and perceived pain measured by Brief Pain Inventory (BFI', 'analgesic usage', 'healthcare costs', 'scores of overall perceived pain', ""pain's interference with relations with others, enjoyment of life, and mood (REM"", 'pain severity', 'quality of care']","[{'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0007876', 'cui_str': 'C-Section (OB)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C1304888', 'cui_str': 'Pain control (procedure)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0347984', 'cui_str': 'During (attribute)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0010995', 'cui_str': 'Data Collection'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0028775', 'cui_str': 'Obstetrics Department'}, {'cui': 'C0587437', 'cui_str': 'Tertiary Hospital'}, {'cui': 'C0332285', 'cui_str': 'In (attribute)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0039260', 'cui_str': 'Formosa'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}]","[{'cui': 'C0557702', 'cui_str': 'Window (physical object)'}, {'cui': 'C0449911', 'cui_str': 'View (attribute)'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0007876', 'cui_str': 'C-Section (OB)'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}]","[{'cui': 'C0030625', 'cui_str': 'PCA'}, {'cui': 'C0457083', 'cui_str': 'Usage (attribute)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0085552', 'cui_str': 'Healthcare Costs'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0424131', 'cui_str': 'Enjoyment of life (observable entity)'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0560134', 'cui_str': 'rem'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0034379', 'cui_str': 'Quality of Care'}]",296.0,0.110289,"RESULTS Higher satisfaction of window view significantly decreased analgesic usage (P = 0.057), reduced the scores of overall perceived pain (P = 0.046), pain severity (P = 0.004), and 'pain's interference with relations with others, enjoyment of life, and mood (REM).'","[{'ForeName': 'Chia-Hui', 'Initials': 'CH', 'LastName': 'Wang', 'Affiliation': 'Department of Urban Development, University of Taipei, No.101, Sec. 2, Zhongcheng Rd., Taipei, Taiwan.'}, {'ForeName': 'Nai-Wen', 'Initials': 'NW', 'LastName': 'Kuo', 'Affiliation': 'College of Public Health, Taipei Medical University, 250 Wu-Xing St., Taipei, Taiwan.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Anthony', 'Affiliation': 'School of Architecture, University of Illinois at Urbana-Champaign, 611 Lorado Taft Drive, Champaign, Illinois, USA.'}]",International journal for quality in health care : journal of the International Society for Quality in Health Care,['10.1093/intqhc/mzz046'] 514,31906903,Study protocol for a randomized control trial to investigate the effectiveness of an 8-week mindfulness-integrated cognitive behavior therapy (MiCBT) transdiagnostic group intervention for primary care patients.,"BACKGROUND Effective transdiagnostic treatments for patients presenting with principal or comorbid symptoms of anxiety and depression enable more efficient provision of mental health care and may be particularly suitable for the varied population seen in primary healthcare settings. Mindfulness-integrated cognitive behavior therapy (MiCBT) is a transdiagnostic intervention that integrates aspects of CBT, including exposure skills targeting avoidance, with training in mindfulness meditation skills adopted from the Vipassana or insight tradition taught by the Burmese teachers U Ba Khin and Goenka. MiCBT is distinguished from both cognitive therapy and mindfulness-based cognitive therapy by the use of a theoretical framework which proposes that the locus of reinforcement of behavior is the interoceptive experience (body sensations) that co-arises with self-referential thinking. Consequently, MiCBT has a strong focus on body scanning to develop interoceptive awareness and equanimity. Designed for clinical purposes, the four-stage systemic approach of MiCBT, comprising intra-personal (Stage 1) exposure (Stage 2), interpersonal (Stage 3), and empathic (Stage 4) skillsets, is a distinguishing feature among other mindfulness-based interventions (MBIs). The aim of this study is to investigate whether and how group MiCBT decreases depression and anxiety symptoms for patients with a range of common mental health conditions. METHODS Participants (n = 120) recruited via medical practitioner referral will be randomized to MiCBT or a wait-list control. Inclusion criteria are age 18-75; fluent in English and having a Kessler Psychological Distress Scale (K10) score of 20 or more. The MiCBT treatment group receive an 8-week MiCBT intervention delivered in a private psychology practice. Participants complete a suite of online self-report measures and record the amount of meditation practice undertaken each week. The control group receive usual treatment and complete the measures at the same time points. Primary outcome measures are the Depression Anxiety Stress Scale-21 (DASS-21) and K10. Analysis will use mixed-model repeated measures. DISCUSSION The potential ability of MiCBT to provide a comprehensive therapeutic system that is applicable across diagnostic groups would make it an attractive addition to the available MBIs. TRIAL REGISTRATION This trial is registered with the Australia and New Zealand Clinical Trials Registry: ACTRN12617000061336; Date of registration: 11th January 2017.",2020,MiCBT is distinguished from both cognitive therapy and mindfulness-based cognitive therapy by the use of a theoretical framework which proposes that the locus of reinforcement of behavior is the interoceptive experience (body sensations) that co-arises with self-referential thinking.,"['primary care patients', 'patients presenting with principal or comorbid symptoms of anxiety and depression', 'patients with a range of common mental health conditions', 'Participants (n\xa0=\u2009120) recruited via medical practitioner referral', 'Inclusion criteria are age 18-75; fluent in English and having a Kessler Psychological Distress Scale (K10) score of 20 or more']","['MiCBT or a wait-list control', 'MiCBT', 'Mindfulness-integrated cognitive behavior therapy (MiCBT', '8-week mindfulness-integrated cognitive behavior therapy (MiCBT) transdiagnostic group intervention', 'MiCBT intervention']","['depression and anxiety symptoms', 'Depression Anxiety Stress Scale-21 (DASS-21) and K10']","[{'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0401925', 'cui_str': 'Teaching principal (occupation)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0205214', 'cui_str': 'Common (qualifier value)'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C1306754', 'cui_str': 'Medical practitioner (occupation)'}, {'cui': 'C0034927', 'cui_str': 'Referral'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3540738', 'cui_str': 'English [International Organization for Standardization 639-1 code en] language reference set (foundation metadata concept)'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]","[{'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0222045'}]",,0.0452718,MiCBT is distinguished from both cognitive therapy and mindfulness-based cognitive therapy by the use of a theoretical framework which proposes that the locus of reinforcement of behavior is the interoceptive experience (body sensations) that co-arises with self-referential thinking.,"[{'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Frances', 'Affiliation': 'Southern Synergy, Department of Psychiatry, School of Clinical Sciences at Monash Health, Monash University, Clayton, Victoria, 3800, Australia. sefra3@student.monash.edu.'}, {'ForeName': 'Frances', 'Initials': 'F', 'LastName': 'Shawyer', 'Affiliation': 'Southern Synergy, Department of Psychiatry, School of Clinical Sciences at Monash Health, Monash University, Clayton, Victoria, 3800, Australia.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Cayoun', 'Affiliation': 'Mindfulness-integrated Cognitive Behavior Therapy Institute, Hobart, Tasmania, Australia.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Enticott', 'Affiliation': 'Southern Synergy, Department of Psychiatry, School of Clinical Sciences at Monash Health, Monash University, Clayton, Victoria, 3800, Australia.'}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'Meadows', 'Affiliation': 'Southern Synergy, Department of Psychiatry, School of Clinical Sciences at Monash Health, Monash University, Clayton, Victoria, 3800, Australia.'}]",BMC psychiatry,['10.1186/s12888-019-2411-1'] 515,31602573,Adhesion Evaluation of AG200-15: An Investigational Transdermal Contraceptive Delivery System.,"INTRODUCTION AG200-15, an investigational transdermal contraceptive delivery system or patch, is designed to be a low-dose, non-daily, combined hormonal contraceptive option for women. In this phase 1 study, the in vivo adhesion of the AG200-15 patch was compared to Xulane ® , the only contraceptive patch available in the USA. METHODS This phase 1, randomized, open-label, single-dose, two-treatment, two-period crossover adhesion study compared the 7-day adhesion of the AG200-15 and Xulane contraceptive patches. Eighty-three women, ages 18 to 35 years old, with body mass index (BMI) ≥ 19 kg/m 2 and < 35 kg/m 2 , and weight ≥ 48 kg and < 90 kg were enrolled. Trained study site personnel used a five-point scale to assess patch adhesion daily. A score of 0 reflected at least 90% adhesion; while a score of 4 represented complete detachment of the patch. The primary objective was to compare the adhesion properties of the two patches; AG200-15 would be considered statistically non-inferior to Xulane if the upper 95% confidence limit (CL) of the mean difference in adhesion scores was below + 0.15. RESULTS The overall mean (standard deviation) scores for AG200-15 (N = 78) and Xulane (N = 77) were 0.14 (0.28) and 0.39 (0.40), respectively (lower scores on the adhesion scale indicate better adhesion). The study demonstrated a difference in mean adhesion scores of - 0.24, meeting the prespecified non-inferiority criterion by demonstrating a one-sided upper CL of - 0.16. Thus, the in vivo adhesion of AG200-15 was shown to be non-inferior to that of Xulane. Most subjects experienced no skin irritation at the application site for either patch and no serious adverse event was reported in the study. CONCLUSION The in vivo adhesion of AG200-15 is non-inferior to that of Xulane on the basis of the prespecified criterion of the upper bound of the one-sided 95% CL for the mean adhesion score difference being below + 0.15. Both patches were generally well tolerated. FUNDING Agile Therapeutics, Inc.",2019,"Most subjects experienced no skin irritation at the application site for either patch and no serious adverse event was reported in the study. ","['Eighty-three women, ages 18 to 35\xa0years old, with body mass index (BMI)\u2009≥\u200919\xa0kg/m 2 and <\u200935\xa0kg/m 2 , and weight ≥\u200948\xa0kg and <\u200990\xa0kg were enrolled', 'women']",['AG200-15 and Xulane contraceptive patches'],"['tolerated', 'adhesion properties', 'skin irritation', 'adhesion scores', 'mean adhesion scores', 'overall mean (standard deviation) scores']","[{'cui': 'C4517888', 'cui_str': '83'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0439087', 'cui_str': '<90 (qualifier value)'}]","[{'cui': 'C3819061', 'cui_str': 'Xulane'}, {'cui': 'C2985284', 'cui_str': 'Contraceptive patch'}]","[{'cui': 'C0001511', 'cui_str': 'Tissue Adhesions'}, {'cui': 'C0871161', 'cui_str': 'Property (attribute)'}, {'cui': 'C0152030', 'cui_str': 'Skin irritation (disorder)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}]",83.0,0.0401896,"Most subjects experienced no skin irritation at the application site for either patch and no serious adverse event was reported in the study. ","[{'ForeName': 'Terrance', 'Initials': 'T', 'LastName': 'Ocheltree', 'Affiliation': 'PharmTree Consultants, LLC, Libertyville, IL, USA.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Wittes', 'Affiliation': 'Statistics Collaborative, Inc., Washington, DC, USA.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Case', 'Affiliation': 'Statistics Collaborative, Inc., Washington, DC, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Tuley', 'Affiliation': 'TKL Research Inc., Fair Lawn, NJ, USA.'}, {'ForeName': 'Irina', 'Initials': 'I', 'LastName': 'Krause', 'Affiliation': 'TKL Research Inc., Fair Lawn, NJ, USA.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Chiodo', 'Affiliation': 'Agile Therapeutics Inc., Princeton, NJ, USA. jachiodo@agiletherapeutics.com.'}, {'ForeName': 'Elizabeth I O', 'Initials': 'EIO', 'LastName': 'Garner', 'Affiliation': 'Agile Therapeutics Inc., Princeton, NJ, USA.'}]",Advances in therapy,['10.1007/s12325-019-01108-z'] 516,30872770,Safety and efficacy of intravitreal conbercept injection after vitrectomy for the treatment of proliferative diabetic retinopathy.,"BACKGROUND/OBJECTIVES The aim of this study was to evaluate the safety and efficacy of intravitreal conbercept (a recombinant fusion protein that primarily targets vascular endothelial growth factors) after vitrectomy for the management of proliferative diabetic retinopathy without tractional retinal detachment (TRD). SUBJECTS/METHODS Fifty patients with non-clearing vitreous haemorrhage (VH) due to proliferative diabetic retinopathy without TRD were enroled. They were randomly divided into control and treatment groups (25 eyes to each group) after they provided informed consent. The treatment group received intravitreal conbercept (10 mg/mL, 0.5 mg) immediately after surgery, while the control group did not. The best corrected visual acuity (BCVA) and the central retinal thickness were measured. RESULTS There were no significant between-group differences in baseline characteristics (P > 0.05), except in age (P = 0.003). Improvement in BCVA was significantly greater at 1, 4, 12, and 24 weeks post surgery in the treatment group than it was in the control group (P < 0.001). There were more cases in the control group who developed recurrent VH, but the recurrence rate of VH was not significantly different between the two groups at 12 and 24 weeks post surgery (P = 0.192 and  0.103). Central retinal thickness was lower in the treatment group than in the control group at 1 week (P = 0.012), 4 weeks (P = 0.01), 12 weeks (P = 0.001), and 24 weeks (P = 0.004) post surgery, which were statistically significant. CONCLUSIONS An intravitreal injection of conbercept after vitrectomy improved visual acuity and seemed to reduce the recurrence of VH resulting in prompt visual recovery in the PDR patients.",2019,"Central retinal thickness was lower in the treatment group than in the control group at 1 week (P = 0.012), 4 weeks","['proliferative diabetic retinopathy', 'proliferative diabetic retinopathy without tractional retinal detachment (TRD', 'Fifty patients with non-clearing vitreous haemorrhage (VH) due to proliferative diabetic retinopathy without TRD were enroled']","['intravitreal conbercept (a recombinant fusion protein', 'intravitreal conbercept', 'intravitreal conbercept injection after vitrectomy']","['recurrence of VH', 'safety and efficacy', 'corrected visual acuity (BCVA) and the central retinal thickness', 'visual acuity', 'recurrent VH', 'recurrence rate of VH', 'BCVA', 'Central retinal thickness', 'Safety and efficacy']","[{'cui': 'C0154830', 'cui_str': 'PDR - proliferative diabetic retinopathy'}, {'cui': 'C0154828', 'cui_str': 'Traction detachment of retina (disorder)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2963144', 'cui_str': 'Clear (qualifier value)'}, {'cui': 'C0042909', 'cui_str': 'Vitreous Hemorrhage'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}]","[{'cui': 'C2352201', 'cui_str': 'KH902 fusion protein'}, {'cui': 'C0034857', 'cui_str': 'Recombinant Fusion Proteins'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0042903', 'cui_str': 'Vitrectomy'}]","[{'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity (observable entity)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0035331', 'cui_str': 'Retinal'}, {'cui': 'C0042812', 'cui_str': 'Visual Acuity'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}]",50.0,0.060211,"Central retinal thickness was lower in the treatment group than in the control group at 1 week (P = 0.012), 4 weeks","[{'ForeName': 'Xinjun', 'Initials': 'X', 'LastName': 'Ren', 'Affiliation': 'Tianjin Medical University Eye Hospital & Tianjin Medical University Eye Institute, Tianjin, China.'}, {'ForeName': 'Shaochong', 'Initials': 'S', 'LastName': 'Bu', 'Affiliation': 'Tianjin Medical University Eye Hospital & Tianjin Medical University Eye Institute, Tianjin, China.'}, {'ForeName': 'Xiaomin', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Tianjin Medical University Eye Hospital & Tianjin Medical University Eye Institute, Tianjin, China.'}, {'ForeName': 'Yuanfeng', 'Initials': 'Y', 'LastName': 'Jiang', 'Affiliation': 'Tianjin Medical University Eye Hospital & Tianjin Medical University Eye Institute, Tianjin, China.'}, {'ForeName': 'Liangzhang', 'Initials': 'L', 'LastName': 'Tan', 'Affiliation': 'Tianjin Medical University Eye Hospital & Tianjin Medical University Eye Institute, Tianjin, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Tianjin Medical University Eye Hospital & Tianjin Medical University Eye Institute, Tianjin, China.'}, {'ForeName': 'Xiaorong', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Tianjin Medical University Eye Hospital & Tianjin Medical University Eye Institute, Tianjin, China. xiaorli@163.com.'}]","Eye (London, England)",['10.1038/s41433-019-0396-0'] 517,31023863,"A Pilot, Phase II, Randomized, Open-Label Clinical Trial Comparing the Neurotoxicity of Three Dose Regimens of Nab-Paclitaxel to That of Solvent-Based Paclitaxel as the First-Line Treatment for Patients with Human Epidermal Growth Factor Receptor Type 2-Negative Metastatic Breast Cancer.","BACKGROUND This study aimed to characterize the neurotoxicity of three different regimens of nab-paclitaxel compared with a standard regimen of solvent-based (sb) paclitaxel for the first-line treatment of HER2-negative metastatic breast cancer based on the Total Neurotoxicity Score (TNS), a tool specifically developed to assess chemotherapy-induced neurotoxicity. MATERIALS AND METHODS This was a randomized, open-label study testing 4-week cycles of 80 mg/m 2 sb-paclitaxel (PACL80/w) on days 1, 8, and 15; 100 mg/m 2 nab-paclitaxel on days 1, 8, and 15 (NAB100/w); 150 mg/m 2 nab-paclitaxel on days 1, 8, and 15 (NAB150/w); and 150 mg/m 2 nab-paclitaxel on days 1 and 15 (NAB150/2w). In addition to the TNS, neuropathy was assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE). Tumor response and quality of life were also evaluated. RESULTS Neurotoxicity, as evaluated by the TNS, did not significantly differ between the sb-paclitaxel group and any of the nab-paclitaxel groups. The frequency of (any grade) polyneuropathy, as measured by the NCI-CTCAE, was lower in the PACL80/w ( n = 7, 50%) and NAB150/2w ( n = 10, 62.5%) groups than in the NAB100/w ( n = 13, 81.3%) or NAB150/w ( n = 11, 78.6%) group. Although the differences were not statistically significant, compared with the other groups, in the NAB150/w group, the time to occurrence of grade ≥2 polyneuropathy was shorter, and the median time to recovery from grade ≥2 polyneuropathy was longer. Dose delays and reductions due to neurotoxicity and impact of neurotoxicity on the patients' experience of symptoms and functional limitations was greater with NAB150/w. Among the seven polymorphisms selected for genotyping, the variant alleles of EPHA5 -rs7349683, EPHA6 -rs301927, and EPHA8 -rs209709 were associated with an increased risk of paclitaxel-induced neuropathy. CONCLUSION The results of this exploratory study showed that, regardless of the dose, nab-paclitaxel did not differ from sb-paclitaxel in terms of neurotoxicity as evaluated with the TNS. However, results from NCI-CTCAE, dose delays and reductions, and functional tools consistently indicate that NAB150/w regimen is associated with a greater risk of chemotherapy-induced neuropathy. Thus, our results question the superiority of the TNS over NCI-CTCAE for evaluating chemotherapy-induced neuropathy and guiding treatment decisions in this context. The selection of the nab-paclitaxel regimen should be individualized based on the clinical context and potentially supported by pharmacogenetic analysis. Registry: EudraCT, 2012-002361-36; NCT01763710 IMPLICATIONS FOR PRACTICE: The results of this study call into question the superiority of the Total Neurotoxicity Score over the National Cancer Institute Common Terminology Criteria for Adverse Events for evaluating chemotherapy-induced neuropathy and guiding treatment decisions in this context and suggest that a regimen of 150 mg/m 2 nab-paclitaxel administered on days 1, 8, and 15 is associated with a greater risk of chemotherapy-induced neuropathy and hematological toxicity compared with other lower-dose nab-paclitaxel regimens or a standard regimen of solvent-based paclitaxel. The selection of the nab-paclitaxel regimen should be individualized based on the clinical context and could benefit from pharmacogenetics analysis.",2019,"Although the differences were not statistically significant, compared with the other groups, in the NAB150/w group, the time to occurrence of grade ≥2 polyneuropathy was shorter, and the median time to recovery from grade ≥2 polyneuropathy was longer.","['HER2-negative metastatic breast cancer', 'Patients with Human Epidermal Growth Factor Receptor Type 2-Negative Metastatic Breast Cancer']","['EPHA6', 'solvent-based (sb) paclitaxel', 'Nab-Paclitaxel to That of Solvent-Based Paclitaxel', '80 mg/m 2 sb-paclitaxel (PACL80/w', 'EPHA5', 'nab-paclitaxel', 'solvent-based paclitaxel', 'EPHA8']","['Tumor response and quality of life', 'neurotoxicity and impact of neurotoxicity', 'Total Neurotoxicity Score', 'risk of paclitaxel-induced neuropathy', 'frequency of (any grade) polyneuropathy', 'neurotoxicity', 'neuropathy and hematological toxicity', 'time to occurrence of grade ≥2 polyneuropathy', 'Total Neurotoxicity Score (TNS']","[{'cui': 'C4087376', 'cui_str': 'HER2 negative'}, {'cui': 'C0278488', 'cui_str': 'Breast cancer metastatic'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1509244', 'cui_str': 'nepidermin'}, {'cui': 'C0597357', 'cui_str': 'Receptor (substance)'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}]","[{'cui': 'C0037638', 'cui_str': 'Solvents'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C1527223', 'cui_str': '130-nm albumin-bound paclitaxel'}]","[{'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0034380'}, {'cui': 'C0235032', 'cui_str': 'Neurotoxin Diseases'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0442874', 'cui_str': 'Neuropathy (disorder)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0152025', 'cui_str': 'Polyneuropathy'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0045733', 'cui_str': 'mansic acid'}]",,0.0191775,"Although the differences were not statistically significant, compared with the other groups, in the NAB150/w group, the time to occurrence of grade ≥2 polyneuropathy was shorter, and the median time to recovery from grade ≥2 polyneuropathy was longer.","[{'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Ciruelos', 'Affiliation': 'Medical Oncology Department, Hospital Universitario 12 de Octubre, Madrid, Spain eva.ciruelos@gmail.com.'}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'Apellániz-Ruiz', 'Affiliation': 'Hereditary Endocrine Cancer Group, Human Cancer Genetics Programme, Spanish National Cancer Research Center (CNIO), Madrid, Spain.'}, {'ForeName': 'Blanca', 'Initials': 'B', 'LastName': 'Cantos', 'Affiliation': 'Oncosur Study Group, Madrid, Spain.'}, {'ForeName': 'Noelia', 'Initials': 'N', 'LastName': 'Martinez-Jáñez', 'Affiliation': 'Oncosur Study Group, Madrid, Spain.'}, {'ForeName': 'Coralia', 'Initials': 'C', 'LastName': 'Bueno-Muiño', 'Affiliation': 'Oncosur Study Group, Madrid, Spain.'}, {'ForeName': 'Maria-Jose', 'Initials': 'MJ', 'LastName': 'Echarri', 'Affiliation': 'Oncosur Study Group, Madrid, Spain.'}, {'ForeName': 'Santos', 'Initials': 'S', 'LastName': 'Enrech', 'Affiliation': 'Oncosur Study Group, Madrid, Spain.'}, {'ForeName': 'Juan-Antonio', 'Initials': 'JA', 'LastName': 'Guerra', 'Affiliation': 'Oncosur Study Group, Madrid, Spain.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Manso', 'Affiliation': 'Medical Oncology Department, Hospital Universitario 12 de Octubre, Madrid, Spain.'}, {'ForeName': 'Tomas', 'Initials': 'T', 'LastName': 'Pascual', 'Affiliation': 'Medical Oncology Department, Hospital Universitario 12 de Octubre, Madrid, Spain.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Dominguez', 'Affiliation': 'Medical Oncology Department, Hospital Universitario 12 de Octubre, Madrid, Spain.'}, {'ForeName': 'Juan-Francisco', 'Initials': 'JF', 'LastName': 'Gonzalo', 'Affiliation': 'Medical Oncology Department, Hospital Universitario 12 de Octubre, Madrid, Spain.'}, {'ForeName': 'Juan-Luis', 'Initials': 'JL', 'LastName': 'Sanz', 'Affiliation': 'Clinical Research Department, Apoyo a la Investigación Clínica en España (APICES), Madrid, Spain.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Rodriguez-Antona', 'Affiliation': 'Hereditary Endocrine Cancer Group, Human Cancer Genetics Programme, Spanish National Cancer Research Center (CNIO), Madrid, Spain.'}, {'ForeName': 'Juan-Manuel', 'Initials': 'JM', 'LastName': 'Sepúlveda', 'Affiliation': 'Medical Oncology Department, Hospital Universitario 12 de Octubre, Madrid, Spain.'}]",The oncologist,['10.1634/theoncologist.2017-0664'] 518,32215634,"Association of Race and Ethnicity With Late-Life Depression Severity, Symptom Burden, and Care.","Importance Knowledge gaps persist regarding racial and ethnic variation in late-life depression, including differences in specific depressive symptoms and disparities in care. Objective To examine racial/ethnic differences in depression severity, symptom burden, and care. Design, Setting, and Participants This cross-sectional study included 25 503 of 25 871 community-dwelling older adults who participated in the Vitamin D and Omega-3 Trial (VITAL), a randomized trial of cancer and cardiovascular disease prevention conducted from November 2011 to December 2017. Data analysis was conducted from June to September 2018. Exposure Racial/ethnic group (ie, non-Hispanic white; black; Hispanic; Asian; and other, multiple, or unspecified race). Main Outcomes and Measures Depressive symptoms, assessed using the Patient Health Questionnaire-8 (PHQ-8); participant-reported diagnosis, medication, and/or counseling for depression. Differences across racial/ethnic groups were evaluated using multivariable zero-inflated negative binomial regression to compare PHQ-8 scores and multivariable logistic regression to estimate odds of item-level symptom burden and odds of depression treatment among those with diagnosed depression. Results There were 25 503 VITAL participants with adequate depression data (mean [SD] age, 67.1 [7.1] years) including 12 888 [50.5%] women, 17 828 [69.9%] non-Hispanic white participants, 5004 [19.6%] black participants, 1001 [3.9%] Hispanic participants, 377 [1.5%] Asian participants, and 1293 participants [5.1%] who were categorized in the other, multiple, or unspecified race group. After adjustment for sociodemographic, lifestyle, and health confounders, black participants had a 10% higher severity level of PHQ-8 scores compared with non-Hispanic white participants (rate ratio [RR], 1.10; 95% CI, 1.04-1.17; P < .001); Hispanic participants had a 23% higher severity level of PHQ-8 scores compared with non-Hispanic white participants (RR, 1.23; 95% CI, 1.10-1.38; P < .001); and participants in the other, multiple, or unspecified group had a 14% higher severity level of PHQ-8 scores compared with non-Hispanic white participants (RR, 1.14; 95% CI, 1.04-1.25; P = .007). Compared with non-Hispanic white participants, participants belonging to minority groups had 1.5-fold to 2-fold significantly higher fully adjusted odds of anhedonia (among black participants: odds ratio [OR], 1.76; 95% CI, 1.47-2.11; among Hispanic participants: OR, 1.96; 95% CI, 1.43-2.69), sadness (among black participants: OR, 1.31; 95% CI, 1.07-1.60; among Hispanic participants: OR, 2.09; 95% CI, 1.51-2.88), and psychomotor symptoms (among black participants: OR, 1.77; 95% CI, 1.31-2.39; among Hispanic participants: OR, 2.12; 95% CI, 1.28-3.50); multivariable-adjusted odds of sleep problems and guilt appeared higher among Hispanic vs non-Hispanic white participants (sleep: OR, 1.24; 95% CI, 1.01-1.52; guilt: 1.84; 95% CI, 1.31-2.59). Among those with clinically significant depressive symptoms (ie, PHQ-8 score ≥10) and/or those with diagnosed depression, black participants were 61% less likely to report any treatment (ie, medications and/or counseling) than non-Hispanic white participants after adjusting for confounders (adjusted OR, 0.39; 95% CI, 0.27-0.56). Conclusions and Relevance In this cross-sectional study, significant racial and ethnic differences in late-life depression severity, item-level symptom burden, and depression care were observed after adjustment for numerous confounders. These findings suggest a need for further examination of novel patient-level and clinician-level factors underlying these associations.",2020,"Compared with non-Hispanic white participants, participants belonging to minority groups had 1.5-fold to 2-fold significantly higher fully adjusted odds of anhedonia (among black participants: odds ratio [OR], 1.76; 95% CI, 1.47-2.11; among Hispanic participants: OR, 1.96; 95% CI, 1.43-2.69), sadness (among black participants: OR, 1.31; 95% CI, 1.07-1.60; among Hispanic participants: OR, 2.09; 95% CI, 1.51-2.88), and psychomotor symptoms (among black participants: OR, 1.77; 95% CI, 1.31-2.39; among Hispanic participants: OR, 2.12; 95% CI, 1.28-3.50); multivariable-adjusted odds of sleep problems and guilt appeared higher among Hispanic vs non-Hispanic white participants (sleep: OR, 1.24; 95% CI, 1.01-1.52; guilt: 1.84; 95% CI, 1.31-2.59).","['There were 25\u202f503 VITAL participants with adequate depression data (mean [SD] age, 67.1 [7.1] years) including 12\u202f888 [50.5%] women, 17\u202f828 [69.9%] non-Hispanic white participants, 5004 [19.6%] black participants, 1001 [3.9%] Hispanic participants, 377 [1.5%] Asian participants, and 1293 participants [5.1%] who were categorized in the other, multiple, or unspecified race group', 'Participants\n\n\nThis cross-sectional study included 25\u202f503 of 25\u202f871 community-dwelling older adults who participated in the Vitamin D and Omega-3 Trial (VITAL), a randomized trial of cancer and cardiovascular disease prevention conducted from November 2011 to December 2017']",[],"['late-life depression severity, item-level symptom burden, and depression care', 'severity level of PHQ-8 scores', 'anhedonia', 'Measures\n\n\nDepressive symptoms, assessed using the Patient Health Questionnaire-8 (PHQ-8); participant-reported diagnosis, medication, and/or counseling for depression', 'depression severity, symptom burden, and care', 'psychomotor symptoms', 'depressive symptoms']","[{'cui': 'C0442732', 'cui_str': 'Vital (qualifier value)'}, {'cui': 'C0205411', 'cui_str': 'Adequate (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C4517698', 'cui_str': '3.9 (qualifier value)'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0078988', 'cui_str': 'Asians'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0205370', 'cui_str': 'Non-specific (qualifier value)'}, {'cui': 'C3853635', 'cui_str': 'Race (observable entity)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0010362', 'cui_str': 'Disease Frequency Surveys'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C1719844', 'cui_str': 'Greek letter omega'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}]",[],"[{'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0178417', 'cui_str': 'Anhedonia'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C1879301', 'cui_str': 'Patient Health Questionnaire'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0341618', 'cui_str': 'Counsel (occupation)'}]",25503.0,0.25102,"Compared with non-Hispanic white participants, participants belonging to minority groups had 1.5-fold to 2-fold significantly higher fully adjusted odds of anhedonia (among black participants: odds ratio [OR], 1.76; 95% CI, 1.47-2.11; among Hispanic participants: OR, 1.96; 95% CI, 1.43-2.69), sadness (among black participants: OR, 1.31; 95% CI, 1.07-1.60; among Hispanic participants: OR, 2.09; 95% CI, 1.51-2.88), and psychomotor symptoms (among black participants: OR, 1.77; 95% CI, 1.31-2.39; among Hispanic participants: OR, 2.12; 95% CI, 1.28-3.50); multivariable-adjusted odds of sleep problems and guilt appeared higher among Hispanic vs non-Hispanic white participants (sleep: OR, 1.24; 95% CI, 1.01-1.52; guilt: 1.84; 95% CI, 1.31-2.59).","[{'ForeName': 'Chirag M', 'Initials': 'CM', 'LastName': 'Vyas', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, Boston.'}, {'ForeName': 'Macarius', 'Initials': 'M', 'LastName': 'Donneyong', 'Affiliation': 'College of Pharmacy, The Ohio State University, Columbus.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Mischoulon', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, Boston.'}, {'ForeName': 'Grace', 'Initials': 'G', 'LastName': 'Chang', 'Affiliation': 'Department of Psychiatry, VA Boston Healthcare System, Brockton, Massachusetts.'}, {'ForeName': 'Heike', 'Initials': 'H', 'LastName': 'Gibson', 'Affiliation': ""Division of Preventive Medicine, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Nancy R', 'Initials': 'NR', 'LastName': 'Cook', 'Affiliation': ""Division of Preventive Medicine, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'JoAnn E', 'Initials': 'JE', 'LastName': 'Manson', 'Affiliation': ""Division of Preventive Medicine, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Charles F', 'Initials': 'CF', 'LastName': 'Reynolds', 'Affiliation': 'Department of Psychiatry, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Olivia I', 'Initials': 'OI', 'LastName': 'Okereke', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, Boston.'}]",JAMA network open,['10.1001/jamanetworkopen.2020.1606'] 519,32215653,"Histological Evaluation of the Skin After Fat Grafting: A Blinded, Randomized, Controlled Clinical Study.","BACKGROUND Autologous fat graft is often employed to treat body contour defects. There is currently increased interest in the regenerative properties of fat grafting. OBJECTIVES The authors evaluated the histological changes of fat grafting in a blinded randomized controlled trial of staged fat grafting-abdominoplasty. METHODS Ten women between 24 and 55 years of age with a body mass index <30 kg/m2 and previous cesarean scar were submitted to fat grafting followed by staged abdominoplasty. The C-section scar served as a landmark for standardization of fat grafting site and control. One side of the abdomen was fat grafted and the other was left intact (control). At the time of abdominoplasty, 4 months later, a full-thickness skin sample from each hemi abdomen (fat-grafted area and control) was collected and sent to histological analysis. RESULTS All of the fat-grafted samples showed extracellular lipids and signs of fat graft viability, whereas no such changes occurred in the control group. There were no statistically significant differences in fat-grafted vs control samples regarding skin inflammatory infiltrate (P = 0.582), dermis thickness (P = 0.973), vascular density (P = 0.326), and amount of elastic fibers (P = 1). CONCLUSIONS The histological evaluation of women's abdominoplasty surgical site skin after 4 months of fat grafting showed signs of fat graft in 100% of the grafted sides but no change in skin inflammatory infiltrate, dermis thickness, vascularity density, or elastic fiber quantity.",2020,"There were no statistically significant differences in fat-grafted vs control samples regarding skin inflammatory infiltrate (P = 0.582), dermis thickness (P = 0.973), vascular density (P = 0.326), and amount of elastic fibers (P = 1). ",['Ten women between 24 and 55 years of age with a body mass index <30 kg/m2 and previous cesarean scar'],"['Skin', 'fat grafting followed by staged abdominoplasty', 'staged fat grafting-abdominoplasty']","['vascular density', 'extracellular lipids and signs of fat graft viability', 'dermis thickness', 'skin inflammatory infiltrate', 'signs of fat graft', 'amount of elastic fibers', 'skin inflammatory infiltrate, dermis thickness, vascularity density, or elastic fiber quantity']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0008767', 'cui_str': 'Cicatrization'}]","[{'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0198542', 'cui_str': 'Abdominoplasty'}, {'cui': 'C1527362', 'cui_str': 'grafts'}]","[{'cui': 'C0178587', 'cui_str': 'Mass to volume ratio'}, {'cui': 'C0521119', 'cui_str': 'Extracellular (qualifier value)'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0311392', 'cui_str': 'Sign'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C1527362', 'cui_str': 'grafts'}, {'cui': 'C0011646', 'cui_str': 'Corium'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0332448', 'cui_str': 'Tissue infiltration'}, {'cui': 'C0230899', 'cui_str': 'Elastic Fibers'}, {'cui': 'C1265611', 'cui_str': 'Quantity finding'}]",10.0,0.0776158,"There were no statistically significant differences in fat-grafted vs control samples regarding skin inflammatory infiltrate (P = 0.582), dermis thickness (P = 0.973), vascular density (P = 0.326), and amount of elastic fibers (P = 1). ","[{'ForeName': 'Juan P B R', 'Initials': 'JPBR', 'LastName': 'Maricevich', 'Affiliation': 'Department of Plastic Surgery, Hospital das Clínicas - UFPE, Recife, Pernambuco, Brazil.'}, {'ForeName': 'Marcel F M B', 'Initials': 'MFMB', 'LastName': 'Lima', 'Affiliation': 'Department of Plastic Surgery, Hospital das Clínicas - UFPE, Recife, Pernambuco, Brazil.'}, {'ForeName': 'Ana Carolina', 'Initials': 'AC', 'LastName': 'Maricevich', 'Affiliation': ''}, {'ForeName': 'Marco A B R', 'Initials': 'MABR', 'LastName': 'Maricevich', 'Affiliation': 'Division of Plastic Surgery, Baylor College of Medicine, Houston, TX.'}, {'ForeName': 'Larissa F J', 'Initials': 'LFJ', 'LastName': 'Silva', 'Affiliation': 'Department of Pathology, Hospital das Clínicas - UFPE, Recife, Pernambuco, Brazil.'}, {'ForeName': 'Daniela M', 'Initials': 'DM', 'LastName': 'Takano', 'Affiliation': 'Department of Pathology, Hospital das Clínicas - UFPE, Recife, Pernambuco, Brazil.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Anlicoara', 'Affiliation': 'Department of Plastic Surgery, Hospital das Clínicas - UFPE, Recife, Pernambuco, Brazil.'}, {'ForeName': 'Álvaro Antônio Bandeira', 'Initials': 'ÁAB', 'LastName': 'Ferraz', 'Affiliation': 'Hospital das Clínicas - UFPE, Recife, Pernambuco, Brazil.'}]",Aesthetic surgery journal,['10.1093/asj/sjz327'] 520,31667490,Depression and Incident HIV in Adolescent Girls and Young Women in HIV Prevention Trials Network 068: Targets for Prevention and Mediating Factors.,"The human immunodeficiency virus (HIV) epidemic among adolescent girls and young women (AGYW) in sub-Saharan Africa is a critical public health problem. We assessed whether depressive symptoms in AGYW were longitudinally associated with incident HIV, and identified potential social and behavioral mediators. Data came from a randomized trial of a cash transfer conditional on school attendance among AGYW (ages 13-21 years) in rural Mpumalanga Province, South Africa, during 2011-2017. We estimated the relationship between depressive symptoms and cumulative HIV incidence using a linear probability model, and we assessed mediation using inverse odds ratio weighting. Inference was calculated using the nonparametric bootstrap. AGYW with depressive symptoms had higher cumulative incidence of HIV compared with those without (risk difference = 3.5, 95% confidence interval (CI): 0.1, 7.0). The strongest individual mediators of this association were parental monitoring and involvement (indirect effect = 1.6, 95% CI: 0.0, 3.3) and reporting a partner would hit her if she asked him to wear a condom (indirect effect = 1.5, 95% CI: -0.3, 3.3). All mediators jointly explained two-thirds (indirect effect = 2.4, 95% CI: 0.2, 4.5) of the association between depressive symptoms and HIV incidence. Interventions addressing mental health might reduce risk of acquiring HIV among AGYW.",2020,"AGYW with depressive symptoms had higher cumulative incidence of HIV compared to those without (risk difference = 3.5 [95% CI 0.1, 7.0]).","['adolescent girls and young women', 'adolescent girls and young women in HPTN 068', 'on school attendance among AGYW (ages 13 - 21) in rural Mpumalanga Province, South Africa during 2011-2017']",['cash transfer conditional'],"['Depression and incident HIV', 'depressive symptoms', 'cumulative incidence of HIV', 'depressive symptoms and HIV incidence', 'depressive symptoms and cumulative HIV incidence']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0237484', 'cui_str': 'School attendance (observable entity)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0037712', 'cui_str': 'Union of South Africa'}]","[{'cui': 'C0040671', 'cui_str': 'Transfer'}]","[{'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0220856', 'cui_str': 'incidence'}]",,0.25429,"AGYW with depressive symptoms had higher cumulative incidence of HIV compared to those without (risk difference = 3.5 [95% CI 0.1, 7.0]).","[{'ForeName': 'Dana E', 'Initials': 'DE', 'LastName': 'Goin', 'Affiliation': 'Division of Epidemiology & Biostatistics, School of Public Health, University of California, Berkeley, Berkeley, California.'}, {'ForeName': 'Rebecca M', 'Initials': 'RM', 'LastName': 'Pearson', 'Affiliation': 'Centre for Academic Mental Health, Population Health Sciences, Bristol Medical School, Bristol University, Bristol, United Kingdom.'}, {'ForeName': 'Michelle G', 'Initials': 'MG', 'LastName': 'Craske', 'Affiliation': 'Department of Psychology, University of California, Los Angeles, Los Angeles, California.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Stein', 'Affiliation': 'Medical Research Council/Wits University Rural Public Health and Health Transitions Research Unit (Agincourt), School of Public Health, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'Pettifor', 'Affiliation': 'Medical Research Council/Wits University Rural Public Health and Health Transitions Research Unit (Agincourt), School of Public Health, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Sheri A', 'Initials': 'SA', 'LastName': 'Lippman', 'Affiliation': 'Medical Research Council/Wits University Rural Public Health and Health Transitions Research Unit (Agincourt), School of Public Health, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Kahn', 'Affiliation': 'Medical Research Council/Wits University Rural Public Health and Health Transitions Research Unit (Agincourt), School of Public Health, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Torsten B', 'Initials': 'TB', 'LastName': 'Neilands', 'Affiliation': 'Division of Prevention Science, Department of Medicine, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Erica L', 'Initials': 'EL', 'LastName': 'Hamilton', 'Affiliation': 'HIV Prevention Trials Network Leadership and Operations Center, Science Facilitation Department, FHI 360, Durham, North Carolina.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Selin', 'Affiliation': 'Medical Research Council/Wits University Rural Public Health and Health Transitions Research Unit (Agincourt), School of Public Health, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'MacPhail', 'Affiliation': 'Medical Research Council/Wits University Rural Public Health and Health Transitions Research Unit (Agincourt), School of Public Health, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Ryan G', 'Initials': 'RG', 'LastName': 'Wagner', 'Affiliation': 'Medical Research Council/Wits University Rural Public Health and Health Transitions Research Unit (Agincourt), School of Public Health, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'F Xavier', 'Initials': 'FX', 'LastName': 'Gomez-Olive', 'Affiliation': 'Medical Research Council/Wits University Rural Public Health and Health Transitions Research Unit (Agincourt), School of Public Health, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Rhian', 'Initials': 'R', 'LastName': 'Twine', 'Affiliation': 'Medical Research Council/Wits University Rural Public Health and Health Transitions Research Unit (Agincourt), School of Public Health, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'James P', 'Initials': 'JP', 'LastName': 'Hughes', 'Affiliation': 'Department of Biostatistics, School of Public Health, University of Washington, Seattle, Washington.'}, {'ForeName': 'Yaw', 'Initials': 'Y', 'LastName': 'Agyei', 'Affiliation': 'Department of Pathology, School of Medicine, Johns Hopkins University, Baltimore, Maryland.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Laeyendecker', 'Affiliation': 'Laboratory of Immunoregulation, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Tollman', 'Affiliation': 'Medical Research Council/Wits University Rural Public Health and Health Transitions Research Unit (Agincourt), School of Public Health, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Ahern', 'Affiliation': 'Division of Epidemiology & Biostatistics, School of Public Health, University of California, Berkeley, Berkeley, California.'}]",American journal of epidemiology,['10.1093/aje/kwz238'] 521,31668476,"Randomized, Sham-Controlled Trial of Real-Time Functional Magnetic Resonance Imaging Neurofeedback for Tics in Adolescents With Tourette Syndrome.","BACKGROUND Activity in the supplementary motor area (SMA) has been associated with tics in Tourette syndrome (TS). The aim of this study was to test a novel intervention-real-time functional magnetic resonance imaging neurofeedback from the SMA-for reduction of tics in adolescents with TS. METHODS Twenty-one adolescents with TS were enrolled in a double-blind, randomized, sham-controlled, crossover study involving two sessions of neurofeedback from their SMA. The primary outcome measure of tic severity was the Yale Global Tic Severity Scale administered by an independent evaluator before and after each arm. The secondary outcome was control over the SMA assessed in neuroimaging scans, in which subjects were cued to increase/decrease activity in SMA without receiving feedback. RESULTS All 21 subjects completed both arms of the study and all assessments. Participants had significantly greater reduction of tics on the Yale Global Tic Severity Scale after real neurofeedback as compared with the sham control (p < .05). Mean Yale Global Tic Severity Scale Total Tic score decreased from 25.2 ± 4.6 at baseline to 19.9 ± 5.7 at end point in the neurofeedback condition and from 24.8 ± 8.1 to 23.3 ± 8.5 in the sham control condition. The 3.8-point difference is clinically meaningful and corresponds to an effect size of 0.59. However, there were no differences in changes on the secondary measure of control over the SMA. CONCLUSIONS This first randomized controlled trial of real-time functional magnetic resonance imaging neurofeedback in adolescents with TS suggests that this neurofeedback intervention may be helpful for improving tic symptoms. However, no effects were found in terms of change in control over the SMA, the hypothesized mechanism of action.",2020,Participants had significantly greater reduction of tics on the Yale Global Tic Severity Scale after real neurofeedback as compared with the sham control (p < .05).,"['Adolescents With Tourette Syndrome', 'Twenty-one adolescents with TS', 'adolescents with TS']",['Real-Time Functional Magnetic Resonance Imaging Neurofeedback'],"['Yale Global Tic Severity Scale administered by an independent evaluator', 'reduction of tics on the Yale Global Tic Severity Scale', 'tic severity', 'control over the SMA assessed in neuroimaging scans', 'Mean Yale Global Tic Severity Scale Total Tic score']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0040517', 'cui_str': 'Chronic Motor and Vocal Tic Disorder'}, {'cui': 'C3715213', 'cui_str': '21 (qualifier value)'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0376335', 'cui_str': 'fMRI'}, {'cui': 'C2713543', 'cui_str': 'Neurofeedback'}]","[{'cui': 'C4720888', 'cui_str': 'Yale global tic severity scale (assessment scale)'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0278076', 'cui_str': 'Habit Chorea'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0679575', 'cui_str': 'Neuroimaging'}, {'cui': 'C0441633'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",21.0,0.452751,Participants had significantly greater reduction of tics on the Yale Global Tic Severity Scale after real neurofeedback as compared with the sham control (p < .05).,"[{'ForeName': 'Denis G', 'Initials': 'DG', 'LastName': 'Sukhodolsky', 'Affiliation': 'Child Study Center, Yale School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Walsh', 'Affiliation': 'Department of Radiology and Biomedical Imaging, Yale School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'William N', 'Initials': 'WN', 'LastName': 'Koller', 'Affiliation': 'Department of Radiology and Biomedical Imaging, Yale School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Eilbott', 'Affiliation': 'SurveyBott LLC, Brooklyn, New York.'}, {'ForeName': 'Mariela', 'Initials': 'M', 'LastName': 'Rance', 'Affiliation': 'Department of Radiology and Biomedical Imaging, Yale School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Robert K', 'Initials': 'RK', 'LastName': 'Fulbright', 'Affiliation': 'Department of Radiology and Biomedical Imaging, Yale School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Zhiying', 'Initials': 'Z', 'LastName': 'Zhao', 'Affiliation': 'Department of Radiology and Biomedical Imaging, Yale School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Michael H', 'Initials': 'MH', 'LastName': 'Bloch', 'Affiliation': 'Child Study Center, Yale School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'King', 'Affiliation': 'Child Study Center, Yale School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'James F', 'Initials': 'JF', 'LastName': 'Leckman', 'Affiliation': 'Child Study Center, Yale School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Dustin', 'Initials': 'D', 'LastName': 'Scheinost', 'Affiliation': 'Child Study Center, Yale School of Medicine, New Haven, Connecticut; Department of Radiology and Biomedical Imaging, Yale School of Medicine, New Haven, Connecticut; Department of Statistics and Data Science, Yale University, New Haven, Connecticut.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Pittman', 'Affiliation': 'Department of Psychiatry, Yale School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Hampson', 'Affiliation': 'Child Study Center, Yale School of Medicine, New Haven, Connecticut; Department of Radiology and Biomedical Imaging, Yale School of Medicine, New Haven, Connecticut; Department of Psychiatry, Yale School of Medicine, New Haven, Connecticut. Electronic address: michelle.hampson@yale.edu.'}]",Biological psychiatry,['10.1016/j.biopsych.2019.07.035'] 522,30404548,A mixed-methods process evaluation of Family Navigation implementation for autism spectrum disorder.,"There is growing interest in Family Navigation as an approach to improving access to care for children with autism spectrum disorder, yet little data exist on the implementation of Family Navigation. The aim of this study was to identify potential failures in implementing Family Navigation for children with autism spectrum disorder, using a failure modes and effects analysis. This mixed-methods study was set within a randomized controlled trial testing the effectiveness of Family Navigation in reducing the time from screening to diagnosis and treatment for autism spectrum disorder across three states. Using standard failure modes and effects analysis methodology, experts in Family Navigation for autism spectrum disorder (n = 9) rated potential failures in implementation on a 10-point scale in three categories: likelihood of the failure occurring, likelihood of not detecting the failure, and severity of failure. Ratings were then used to create a risk priority number for each failure. The failure modes and effects analysis detected five areas for potential ""high priority"" failures in implementation: (1) setting up community-based services, (2) initial family meeting, (3) training, (4) fidelity monitoring, and (5) attending testing appointments. Reasons for failure included families not receptive, scheduling, and insufficient training time. The process with the highest risk profile was ""setting up community-based services."" Failure in ""attending testing appointment"" was rated as the most severe potential failure. A number of potential failures in Family Navigation implementation-along with strategies for mitigation-were identified. These data can guide those working to implement Family Navigation for children with autism spectrum disorder.",2019,"There is growing interest in Family Navigation as an approach to improving access to care for children with autism spectrum disorder, yet little data exist on the implementation of Family Navigation.","['autism spectrum disorder', 'children with autism spectrum disorder']","['Family Navigation implementation', 'implementing Family Navigation', 'Family Navigation']",[' Failure'],"[{'cui': 'C1510586', 'cui_str': 'Autism Spectrum Disorders'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}]","[{'cui': 'C0231174', 'cui_str': 'Failure (finding)'}]",,0.0747241,"There is growing interest in Family Navigation as an approach to improving access to care for children with autism spectrum disorder, yet little data exist on the implementation of Family Navigation.","[{'ForeName': 'Sarabeth', 'Initials': 'S', 'LastName': 'Broder-Fingert', 'Affiliation': '1 Boston University School of Medicine, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Qin', 'Affiliation': ""2 The Children's Hospital of Philadelphia, USA.""}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Goupil', 'Affiliation': ""2 The Children's Hospital of Philadelphia, USA.""}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Rosenberg', 'Affiliation': ""2 The Children's Hospital of Philadelphia, USA.""}, {'ForeName': 'Marilyn', 'Initials': 'M', 'LastName': 'Augustyn', 'Affiliation': '1 Boston University School of Medicine, USA.'}, {'ForeName': 'Nate', 'Initials': 'N', 'LastName': 'Blum', 'Affiliation': '3 Boston Medical Center, USA.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Bennett', 'Affiliation': '3 Boston Medical Center, USA.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Weitzman', 'Affiliation': '4 Yale School of Medicine, USA.'}, {'ForeName': 'James P', 'Initials': 'JP', 'LastName': 'Guevara', 'Affiliation': '3 Boston Medical Center, USA.'}, {'ForeName': 'Ada', 'Initials': 'A', 'LastName': 'Fenick', 'Affiliation': '4 Yale School of Medicine, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Silverstein', 'Affiliation': '1 Boston University School of Medicine, USA.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Feinberg', 'Affiliation': '1 Boston University School of Medicine, USA.'}]",Autism : the international journal of research and practice,['10.1177/1362361318808460'] 523,32217654,The natural history of progressive fibrosing interstitial lung diseases.,"We used data from the INBUILD and INPULSIS trials to investigate the natural history of progressive fibrosing interstitial lung diseases (ILDs).Subjects in the two INPULSIS trials had a clinical diagnosis of idiopathic pulmonary fibrosis (IPF) while subjects in the INBUILD trial had a progressive fibrosing ILD other than IPF and met protocol-defined criteria for ILD progression despite management. Using data from the placebo groups, we compared the rate of decline in forced vital capacity (FVC) (mL·year -1 ) and mortality over 52 weeks in the INBUILD trial with pooled data from the INPULSIS trials.The adjusted mean annual rate of decline in FVC in the INBUILD trial (n=331) was similar to that observed in the INPULSIS trials (n=423) (-192.9 mL·year -1 and -221.0 mL·year -1 , respectively; nominal p-value=0.19). The proportion of subjects who had a relative decline in FVC >10% predicted at Week 52 was 48.9% in the INBUILD trial and 48.7% in the INPULSIS trials, and the proportion who died over 52 weeks was 5.1% in the INBUILD trial and 7.8% in the INPULSIS trials. A relative decline in FVC >10% predicted was associated with an increased risk of death in the INBUILD trial (hazard ratio 3.64) and the INPULSIS trials (hazard ratio 3.95).These findings indicate that patients with fibrosing ILDs other than IPF, who are progressing despite management, have a subsequent clinical course similar to patients with untreated IPF, with a high risk of further ILD progression and early mortality.",2020,"The proportion of subjects who had a relative decline in FVC >10% predicted at week 52 was 48.9% in the INBUILD trial and 48.7% in the INPULSIS trials, and the proportion who died over 52 weeks was 5.1% in the INBUILD trial and 7.8% in the INPULSIS trials.",[],['placebo'],"['rate of decline in forced vital capacity (FVC) (mL·year -1 ) and mortality', 'risk of death']",[],"[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C3714541', 'cui_str': 'Forced Vital Capacity'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",,0.169527,"The proportion of subjects who had a relative decline in FVC >10% predicted at week 52 was 48.9% in the INBUILD trial and 48.7% in the INPULSIS trials, and the proportion who died over 52 weeks was 5.1% in the INBUILD trial and 7.8% in the INPULSIS trials.","[{'ForeName': 'Kevin K', 'Initials': 'KK', 'LastName': 'Brown', 'Affiliation': 'Dept of Medicine, National Jewish Health, Denver, CO, USA brownk@njhealth.org.'}, {'ForeName': 'Fernando J', 'Initials': 'FJ', 'LastName': 'Martinez', 'Affiliation': 'Dept of Medicine, Weill Cornell Medicine, New York, NY, USA.'}, {'ForeName': 'Simon L F', 'Initials': 'SLF', 'LastName': 'Walsh', 'Affiliation': 'National Heart and Lung Institute, Imperial College, London, UK.'}, {'ForeName': 'Victor J', 'Initials': 'VJ', 'LastName': 'Thannickal', 'Affiliation': 'Division of Pulmonary, Allergy and Critical Care Medicine, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Antje', 'Initials': 'A', 'LastName': 'Prasse', 'Affiliation': 'Dept of Respiratory Medicine, MHH Hannover Medical School and Biomedical Research in Endstage and Obstructive Lung Disease (BREATH), Deutsches Zentrum für Lungenforschung (DZL), Hannover, Germany.'}, {'ForeName': 'Rozsa', 'Initials': 'R', 'LastName': 'Schlenker-Herceg', 'Affiliation': 'Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT, USA.'}, {'ForeName': 'Rainer-Georg', 'Initials': 'RG', 'LastName': 'Goeldner', 'Affiliation': 'Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach, Germany.'}, {'ForeName': 'Emmanuelle', 'Initials': 'E', 'LastName': 'Clerisme-Beaty', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany.'}, {'ForeName': 'Kay', 'Initials': 'K', 'LastName': 'Tetzlaff', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Cottin', 'Affiliation': 'National Reference Centre for Rare Pulmonary Diseases, Louis Pradel Hospital, Hospices Civils de Lyon, UMR 754, Claude Bernard University Lyon 1, Lyon, France.'}, {'ForeName': 'Athol U', 'Initials': 'AU', 'LastName': 'Wells', 'Affiliation': 'National Heart and Lung Institute, Imperial College, London, UK.'}]",The European respiratory journal,['10.1183/13993003.00085-2020'] 524,30817018,Longitudinal Findings from a Randomized Clinical Trial of Varenicline for Alcohol Use Disorder with Comorbid Cigarette Smoking.,"BACKGROUND This study is the first to examine longitudinal posttreatment outcomes of a placebo-controlled trial of varenicline for alcohol use disorder (AUD) with comorbid cigarette smoking. METHODS Participants were 131 adults (n = 39 female) seeking alcohol treatment in a randomized, double-blind, parallel group, placebo-controlled, 16-week multisite trial of varenicline combined with medical management (MM). Timeline follow-back assessments of alcohol and smoking behavior were conducted at the end of treatment (4 months), with follow-ups at 6, 9, and 12 months. Outcomes were percentage of heavy drinking days (PHDD), percent of participants with no heavy drinking days (NHDD), cotinine-confirmed prolonged smoking abstinence (PA), and good clinical outcome on either NHDD or PA. RESULTS Treatment improvements were maintained posttreatment. For the sample overall, PHDD or NHDD did not differ significantly by treatment condition (ps > 0.13), but varenicline produced higher rates of PA versus placebo at 4, 9, and 12 months (p < 0.05). Significant differences were observed by sex: Males had higher rates of NHDD with varenicline (28.9%) versus placebo (6.4%) at the end of treatment (p = 0.004), and these effects were maintained at 12 months (varenicline: 40.0% vs. placebo: 19.2%, p = 0.03). Higher rates of PA were seen for varenicline in both males (8.9%) and females (21.1%) versus placebo (males/females: 0%) at the end of treatment (p = 0.05), and this effect was maintained at 12 months for females (varenicline: 21.1% vs. placebo, 0.0%, p = 0.05). CONCLUSIONS Varenicline treatment combined with MM appears to have enduring benefits for patients with co-occurring AUD and cigarette smoking, and these effects may differ by sex.",2019,"For the sample overall, PHDD or NHDD did not differ significantly by treatment condition (ps > 0.13), but varenicline produced higher rates of PA versus placebo at 4, 9, and 12 months (p < 0.05).","['Alcohol Use Disorder with Comorbid Cigarette Smoking', 'patients with co-occurring AUD and cigarette smoking', 'Participants were 131 adults (n\xa0=\xa039 female) seeking']","['Varenicline', 'varenicline combined with medical management (MM', 'placebo', 'varenicline', 'alcohol treatment']","['percentage of heavy drinking days (PHDD), percent of participants with no heavy drinking days (NHDD), cotinine-confirmed prolonged smoking abstinence (PA), and good clinical outcome on either NHDD or PA', 'PHDD or NHDD', 'Higher rates of PA', 'rates of NHDD']","[{'cui': 'C0001956', 'cui_str': 'Alcohol Use Disorder'}, {'cui': 'C0700219', 'cui_str': 'Cigarette Smoking'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086287', 'cui_str': 'Females'}]","[{'cui': 'C1569608', 'cui_str': 'varenicline'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0439539', 'cui_str': 'Heavy sensation quality'}, {'cui': 'C0684271', 'cui_str': 'Drinkings'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0439165', 'cui_str': 'Percent (property) (qualifier value)'}, {'cui': 'C0010194', 'cui_str': 'Scotine'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]",131.0,0.102834,"For the sample overall, PHDD or NHDD did not differ significantly by treatment condition (ps > 0.13), but varenicline produced higher rates of PA versus placebo at 4, 9, and 12 months (p < 0.05).","[{'ForeName': 'Krysten W', 'Initials': 'KW', 'LastName': 'Bold', 'Affiliation': 'Department of Psychiatry , Yale School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Allen', 'Initials': 'A', 'LastName': 'Zweben', 'Affiliation': 'School of Social Work , Columbia University, New York, New York.'}, {'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'Fucito', 'Affiliation': 'Department of Psychiatry , Yale School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Mary E', 'Initials': 'ME', 'LastName': 'Piepmeier', 'Affiliation': 'School of Social Work , Columbia University, New York, New York.'}, {'ForeName': 'Srinivas', 'Initials': 'S', 'LastName': 'Muvvala', 'Affiliation': 'Department of Psychiatry , Yale School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Ran', 'Initials': 'R', 'LastName': 'Wu', 'Affiliation': 'Department of Psychiatry , Yale School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Ralitza', 'Initials': 'R', 'LastName': 'Gueorguieva', 'Affiliation': 'Department of Psychiatry , Yale School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Stephanie S', 'Initials': 'SS', 'LastName': ""O'Malley"", 'Affiliation': 'Department of Psychiatry , Yale School of Medicine, New Haven, Connecticut.'}]","Alcoholism, clinical and experimental research",['10.1111/acer.13994'] 525,30916742,Combined Surgery and Extensive Intraoperative Peritoneal Lavage vs Surgery Alone for Treatment of Locally Advanced Gastric Cancer: The SEIPLUS Randomized Clinical Trial.,"Importance Peritoneal metastasis is the most frequent pattern of postoperative recurrence in patients with gastric cancer. Extensive intraoperative peritoneal lavage (EIPL) is a new prophylactic strategy for treatment of peritoneal metastasis of locally advanced gastric cancer; however, the safety and efficacy of EIPL is currently unknown. Objective To evaluate short-term outcomes of patients with advanced gastric cancer who received combined surgery and EIPL or surgery alone. Design, Setting, and Participants From March 2016 to November 2017, 662 patients with advanced gastric cancer receiving D2 gastrectomy were enrolled in a large, multicenter, randomized clinical trial from 11 centers across China. In total, 329 patients were randomly assigned to receive surgery alone, and 333 patients were randomly assigned to receive surgery plus EIPL. Clinical characteristics, operative findings, and postoperative short-term outcomes were compared between the 2 groups in the intent-to-treat population. Main Outcomes and Measures Short-term postoperative complications and mortality. Results The present analysis included data from 550 patients, 390 men and 160 women, with a mean (SD) age of 60.8 (10.7) years in the surgery alone group and 60.6 (10.8) in the surgery plus EIPL group. Patients assigned to the surgery plus EIPL group exhibited reduced mortality (0 of 279 patients) compared with those assigned to surgery alone (5 of 271 patients [1.9%]) (difference, 1.9%; 95% CI, 0.3%-3.4%; P = .02). A significant difference in the overall postoperative complication rate was observed between patients receiving surgery alone (46 patients [17.0%]) and those receiving surgery plus EIPL (31 patients [11.1%]) (difference, 5.9%; 95% CI, 0.1%-11.6%; P = .04). Postoperative pain occurred more often following surgery alone (48 patients [17.7%]) than following surgery plus EIPL (30 patients [10.8%]) (difference, 7.0%; 95% CI, 0.8%-13.1%; P = .02). Conclusions and Relevance Inclusion of EIPL can increase the safety of D2 gastrectomy and decrease postoperative short-term complications and wound pain. As a new, safe, and simple procedure, EIPL therapy is easily performed anywhere and does not require any special devices or techniques. Our study suggests that patients with advanced gastric cancer appear to be candidates for the EIPL approach. Trial Registration ClinicalTrials.gov identifier: NCT02745509.",2019,"Extensive intraoperative peritoneal lavage (EIPL) is a new prophylactic strategy for treatment of peritoneal metastasis of locally advanced gastric cancer; however, the safety and efficacy of EIPL is currently unknown. ","['patients with advanced gastric cancer', 'Participants\n\n\nFrom March 2016 to November 2017, 662 patients with advanced gastric cancer receiving D2 gastrectomy', 'patients with gastric cancer', '550 patients, 390 men and 160 women, with a mean (SD) age of 60.8 (10.7) years in the surgery alone group and 60.6 (10.8) in the surgery plus EIPL group', 'peritoneal metastasis of locally advanced gastric cancer', 'patients with advanced gastric cancer who received', '329 patients were randomly assigned to receive surgery alone, and 333 patients', 'Locally Advanced Gastric Cancer']","['Combined Surgery and Extensive Intraoperative Peritoneal Lavage vs Surgery Alone', 'surgery plus EIPL', 'combined surgery and EIPL or surgery alone', 'Extensive intraoperative peritoneal lavage (EIPL']","['Main Outcomes and Measures\n\n\nShort-term postoperative complications and mortality', 'Postoperative pain', 'mortality', 'overall postoperative complication rate', 'safety of D2 gastrectomy and decrease postoperative short-term complications and wound pain']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0024623', 'cui_str': 'Cancer of Stomach'}, {'cui': 'C0017118', 'cui_str': 'Gastrectomy'}, {'cui': 'C3844103', 'cui_str': '550 (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4517523', 'cui_str': '10.8'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0346989', 'cui_str': 'Secondary malignant peritoneal deposit'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C4517724', 'cui_str': 'Three hundred and thirty-three'}]","[{'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0205231', 'cui_str': 'Extensive (qualifier value)'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0031148', 'cui_str': 'Peritoneal Irrigation'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0205225', 'cui_str': 'Principal (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0017118', 'cui_str': 'Gastrectomy'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0241745', 'cui_str': 'Wound pain (finding)'}]",329.0,0.302794,"Extensive intraoperative peritoneal lavage (EIPL) is a new prophylactic strategy for treatment of peritoneal metastasis of locally advanced gastric cancer; however, the safety and efficacy of EIPL is currently unknown. ","[{'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Guo', 'Affiliation': 'State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, and Department of Gastric Surgery, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, China.'}, {'ForeName': 'Aman', 'Initials': 'A', 'LastName': 'Xu', 'Affiliation': 'Department of Gastrointestinal Surgery, The First Affiliated Hospital of Anhui Medical University, HeFei, Anhui, China.'}, {'ForeName': 'Xiaowei', 'Initials': 'X', 'LastName': 'Sun', 'Affiliation': 'State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, and Department of Gastric Surgery, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, China.'}, {'ForeName': 'Xuhui', 'Initials': 'X', 'LastName': 'Zhao', 'Affiliation': 'Department of General Surgery, The First Affiliated Hospital of University of Science and Technology of China, Anhui Provincial Cancer Hospital, Hefei, Anhui, China.'}, {'ForeName': 'Yabin', 'Initials': 'Y', 'LastName': 'Xia', 'Affiliation': 'Department of General Surgery, The First Affiliated Hospital of Wannan Medical College, Wuhu, Anhui, China.'}, {'ForeName': 'Huamin', 'Initials': 'H', 'LastName': 'Rao', 'Affiliation': 'Department of Abdominal Surgery, Jiangxi Provincial Cancer Hospital, Nanchang, Jiangxi, China.'}, {'ForeName': 'Yaming', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Surgical Oncology, Anqing Municipal Hospital, Anqing, Anhui, China.'}, {'ForeName': 'Rupeng', 'Initials': 'R', 'LastName': 'Zhang', 'Affiliation': 'Department of Gastric Surgery, Tianjin Medical University Cancer Institute and Hospital, Tianjin, Tianjin, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Department of General Surgery, The Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, Zhejiang, China.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Zhang', 'Affiliation': ""Department of Gastrointestinal Surgery, Yuebei People's Hospital, Shaoguan, Guangdong, China.""}, {'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Li', 'Affiliation': 'Department of General Surgery, Jiangsu Cancer Hospital, Nanjing, Jiangsu, China.'}, {'ForeName': 'Hongtao', 'Initials': 'H', 'LastName': 'Xu', 'Affiliation': 'Department of General Surgery, Lishui Municipal Central Hospital, Lishui, Zhejiang, China.'}, {'ForeName': 'Dazhi', 'Initials': 'D', 'LastName': 'Xu', 'Affiliation': 'State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, and Department of Gastric Surgery, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, China.'}]",JAMA surgery,['10.1001/jamasurg.2019.0153'] 526,31500854,Randomized Crossover Trial of Phosphate-binding Medication on Serum Phosphate Levels in Patients With Aortic Stenosis.,"PURPOSE Aortic stenosis is a common cause of valvular heart disease with no means of prevention. The recognized association between aortic stenosis and serum phosphate raises the possibility of preventing progression of the disorder by using phosphate-binding drugs, but there is uncertainty whether such treatment lowers serum phosphate levels in patients without diagnosed renal failure. This pilot study was conducted to answer this question in patients with aortic stenosis. METHODS A randomized, double-blind, crossover trial of the phosphate-binding drug sevelamer was conducted in 72 patients. Patients were prescribed sevelamer 0.8 g (low-dose), sevelamer 2.4 g (high-dose), and matching placebo, 3 times daily with food; each regimen lasted 6 weeks and was allocated at random. Serum phosphate levels were measured at the end of each treatment period, and within-person levels were compared. FINDINGS Sixty-one patients completed the 3 treatment periods. There was no significant difference in the mean end-treatment phosphate levels across all patients (3.38, 3.36, and 3.31 mg/dL with placebo, low-dose sevelamer, and high-dose sevelamer, respectively). Post hoc analysis showed a reduction in phosphate levels with increasing sevelamer dose in the highest baseline phosphate quartile group; a 0.3 mg/dL reduction (mean, 4.09 mg/dL with placebo, 3.95 mg/dL with low-dose sevelamer, and 3.79 mg/dL with high-dose sevelamer; P trend  = 0.027). IMPLICATIONS Sevelamer had no overall statistically significant effect in lowering serum phosphate levels, but a reduction was observed in patients with phosphate levels in the highest quartile group of the population distribution. This hypothesis-generating result requires confirmation in an independent study. If confirmed, a trial of sevelamer in preventing the progression of aortic stenosis may be justified in patients with high phosphate levels. ISRCTN Registry identifier: ISRCTN17365679.",2019,"IMPLICATIONS Sevelamer had no overall statistically significant effect in lowering serum phosphate levels, but a reduction was observed in patients with phosphate levels in the highest quartile group of the population distribution.","['patients with aortic stenosis', '72 patients', 'Patients With Aortic Stenosis', 'patients with high phosphate levels', 'patients without diagnosed renal failure']","['sevelamer 0.8\xa0g (low-dose), sevelamer 2.4\xa0g (high-dose), and matching placebo', 'phosphate-binding drug sevelamer', 'placebo', 'Phosphate-binding Medication', 'sevelamer']","['Serum Phosphate Levels', 'phosphate levels', 'lowering serum phosphate levels', 'Serum phosphate levels', 'mean end-treatment phosphate levels']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0003507', 'cui_str': 'Aortic Stenosis'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0523826', 'cui_str': 'Phosphate measurement (procedure)'}, {'cui': 'C0035078', 'cui_str': 'Kidney Failure'}]","[{'cui': 'C4517481', 'cui_str': '0.8'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C4517631', 'cui_str': '2.4 (qualifier value)'}, {'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1601799', 'cui_str': 'phosphate ion'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}]","[{'cui': 'C0036820', 'cui_str': 'Serum phosphate'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0523826', 'cui_str': 'Phosphate measurement (procedure)'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]",61.0,0.0844807,"IMPLICATIONS Sevelamer had no overall statistically significant effect in lowering serum phosphate levels, but a reduction was observed in patients with phosphate levels in the highest quartile group of the population distribution.","[{'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Wald', 'Affiliation': 'Wolfson Institute of Preventive Medicine, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, United Kingdom. Electronic address: d.s.wald@qmul.ac.uk.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Chambers', 'Affiliation': 'Department of Cardiology, St Thomas Hospital, London, United Kingdom. Electronic address: john.chambers@gstt.nhs.uk.'}, {'ForeName': 'Jonathan P', 'Initials': 'JP', 'LastName': 'Bestwick', 'Affiliation': 'Wolfson Institute of Preventive Medicine, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, United Kingdom. Electronic address: j.p.bestwick@qmul.ac.uk.'}, {'ForeName': 'Nicholas J', 'Initials': 'NJ', 'LastName': 'Wald', 'Affiliation': 'Wolfson Institute of Preventive Medicine, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, United Kingdom. Electronic address: n.j.wald@qmul.ac.uk.'}]",Clinical therapeutics,['10.1016/j.clinthera.2019.08.004'] 527,30951210,Maintenance of World Health Organization Risk Drinking Level Reductions and Posttreatment Functioning Following a Large Alcohol Use Disorder Clinical Trial.,"BACKGROUND Reductions in the World Health Organization (WHO) risk drinking levels have been proposed as an alternative primary outcome for alcohol clinical trials. Yet, little is known about whether reductions in WHO risk drinking levels can be maintained over time. The current study examined whether reductions in WHO risk drinking levels were maintained for up to 1 year following treatment, and whether reductions over time were associated with improvements in functioning. METHODS Secondary data analysis of individuals with alcohol dependence (n = 1,226) enrolled in the COMBINE study, a multisite, randomized, placebo-controlled clinical trial. Logistic regression was used to examine the maintenance of end-of-treatment WHO risk level reductions and WHO risk level reductions at the 1-year follow-up. Repeated-measures mixed models were used to examine the association between WHO risk level reductions and functional outcomes over time. RESULTS Achieving at least a 1- or 2-level reduction in risk by the end of treatment was significantly associated with WHO risk level reductions at the 1-year follow-up assessment (p < 0.001). Among individuals who achieved at least a 1-level reduction by the end of treatment, 85.5% reported at least a 1-level reduction at the 1-year follow-up. Among individuals who achieved at least a 2-level reduction by the end of treatment, 77.8% reported at least a 2-level reduction at the 1-year follow-up. WHO risk level reductions were associated with significantly lower alcohol consumption, better physical health (p < 0.01), and fewer alcohol-related consequences (p < 0.001) up to 1 year following treatment. CONCLUSIONS One- and 2-level reductions in WHO risk levels during alcohol treatment were maintained after treatment and associated with better functioning over time. These findings support the use of the WHO risk level reductions as an outcome measure that reflects clinically significant improvement in how individuals seeking treatment for alcohol use disorder feel and function.",2019,"WHO risk level reductions were associated with significantly lower alcohol consumption, better physical health (p < 0.01), and fewer alcohol-related consequences (p < 0.001) up to 1 year following treatment. ","['Secondary data analysis of individuals with alcohol dependence (n\xa0=\xa01,226']",['placebo'],"['WHO risk level reductions', 'WHO risk levels', '2-level reduction', '1-level reduction', 'alcohol consumption, better physical health', 'WHO risk drinking levels']","[{'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0010992', 'cui_str': 'Data Analysis'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0001973', 'cui_str': 'Alcohol Dependence'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0684271', 'cui_str': 'Drinkings'}]",1226.0,0.0422356,"WHO risk level reductions were associated with significantly lower alcohol consumption, better physical health (p < 0.01), and fewer alcohol-related consequences (p < 0.001) up to 1 year following treatment. ","[{'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Witkiewitz', 'Affiliation': 'Department of Psychology, University of New Mexico, Albuquerque, New Mexico.'}, {'ForeName': 'Daniel E', 'Initials': 'DE', 'LastName': 'Falk', 'Affiliation': 'National Institute on Alcohol Abuse and Alcoholism, Bethesda, Maryland.'}, {'ForeName': 'Raye Z', 'Initials': 'RZ', 'LastName': 'Litten', 'Affiliation': 'National Institute on Alcohol Abuse and Alcoholism, Bethesda, Maryland.'}, {'ForeName': 'Deborah S', 'Initials': 'DS', 'LastName': 'Hasin', 'Affiliation': 'Department of Epidemiology, Columbia University, New York, New York.'}, {'ForeName': 'Henry R', 'Initials': 'HR', 'LastName': 'Kranzler', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Karl F', 'Initials': 'KF', 'LastName': 'Mann', 'Affiliation': 'Medical Faculty Mannheim, Central Institute of Mental Health, Heidelberg University, Mannheim, Germany.'}, {'ForeName': 'Stephanie S', 'Initials': 'SS', 'LastName': ""O'Malley"", 'Affiliation': 'Yale School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Raymond F', 'Initials': 'RF', 'LastName': 'Anton', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, South Carolina.'}]","Alcoholism, clinical and experimental research",['10.1111/acer.14018'] 528,32055002,Survival outcomes and risk group validation from SWOG S0925: a randomized phase II study of cixutumumab in new metastatic hormone-sensitive prostate cancer.,"BACKGROUND Cixutumumab, a monoclonal antibody targeting insulin-like growth factor I receptor, did not improve undetectable prostate-specific antigen (PSA) rate at 28 weeks when combined with androgen deprivation in the randomized phase II SWOG S0925 trial for patients with new metastatic hormone-sensitive prostate cancer. We now present mature survival analyses, along with pre-specified secondary and exploratory endpoints. METHODS We randomized 210 patients to androgen deprivation with or without cixutumumab, 105 per treatment arm. We used Kaplan-Meier curves to analyze overall survival, radiographic progression-free survival, and castration resistance-free survival by treatment arm, disease volume, and risk group. We explored differences in survival by treatment arm via covariate-adjusted Cox proportional hazards models adjusted for disease volume and risk. RESULTS No difference was seen between treatment arms in overall survival (HR 1.01 [0.70-1.45]; p = 0.97), radiographic progression-free survival (HR 1.17 [0.85-1.60]; p = 0.35), or castration resistance-free survival (HR 1.02 [0.75-1.41]; p = 0.88). At baseline, 105/198 (53.0%) patients had high-risk features and 119/210 (56.7%) had high-volume disease; 16.7% of patients had discordant classifications of high or low category for risk and volume. Adjusting for risk or volume yielded no differences in overall survival between arms. Inferior survival was observed in high-risk (HR 1.89 [1.29-2.80]; p = 0.001) and high-volume (HR 2.75 [1.84-4.10]; p < 0.0001) disease. Disease volume was a better fit to survival data than risk group (AIC 878.3 vs. 889.2). Compared to patients achieving undetectable PSA at 28 weeks, inferior survival was observed in patients whose PSA was >0.2 to ≤4.0 ng/mL (HR 3.72 [1.99-6.95]; p < 0.0001) or >4.0 ng/mL (HR 7.13 [4.24-11.9]; p < 0.0001). CONCLUSIONS In new metastatic hormone-sensitive prostate cancer, addition of cixutumumab to androgen deprivation did not improve survival. Baseline risk and disease volume carried prognostic value for this distinct trial population, although disease volume added more prognostic information. PSA treatment response was a strong intermediate endpoint for survival.",2020,"No difference was seen between treatment arms in overall survival (HR 1.01 [0.70-1.45]; p = 0.97), radiographic progression-free survival (HR 1.17 [0.85-1.60]; p = 0.35), or castration resistance-free survival (HR 1.02 [0.75-1.41]; p = 0.88).","['patients with new metastatic hormone-sensitive prostate cancer', '210 patients to androgen deprivation with or without cixutumumab, 105 per treatment arm', 'new metastatic hormone-sensitive prostate cancer']",['cixutumumab'],"['Inferior survival', 'radiographic progression-free survival', 'inferior survival', 'Survival outcomes', 'overall survival, radiographic progression-free survival, and castration resistance-free survival', 'castration resistance-free survival', 'survival', 'overall survival']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C4302896', 'cui_str': 'Hormone sensitive prostate cancer (disorder)'}, {'cui': 'C4319559', 'cui_str': '210'}, {'cui': 'C0002844', 'cui_str': 'Androgenic Compounds'}, {'cui': 'C2699335'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}]",[{'cui': 'C2699335'}],"[{'cui': 'C0542339', 'cui_str': 'Below (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0007344', 'cui_str': 'Gonadectomy'}]",210.0,0.28146,"No difference was seen between treatment arms in overall survival (HR 1.01 [0.70-1.45]; p = 0.97), radiographic progression-free survival (HR 1.17 [0.85-1.60]; p = 0.35), or castration resistance-free survival (HR 1.02 [0.75-1.41]; p = 0.88).","[{'ForeName': 'Risa L', 'Initials': 'RL', 'LastName': 'Wong', 'Affiliation': 'Division of Oncology, Department of Medicine, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Mai T', 'Initials': 'MT', 'LastName': 'Duong', 'Affiliation': 'Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Catherine M', 'Initials': 'CM', 'LastName': 'Tangen', 'Affiliation': 'Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Neeraj', 'Initials': 'N', 'LastName': 'Agarwal', 'Affiliation': 'Huntsman Cancer Institute, University of Utah, Salt Lake City, UT, USA.'}, {'ForeName': 'Heather H', 'Initials': 'HH', 'LastName': 'Cheng', 'Affiliation': 'Division of Oncology, Department of Medicine, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Nicholas J', 'Initials': 'NJ', 'LastName': 'Vogelzang', 'Affiliation': 'US Oncology, Las Vegas, NV, USA.'}, {'ForeName': 'Maha', 'Initials': 'M', 'LastName': 'Hussain', 'Affiliation': 'Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.'}, {'ForeName': 'Ian M', 'Initials': 'IM', 'LastName': 'Thompson', 'Affiliation': 'CHRISTUS Santa Rosa Medical Center Hospital, San Antonio, TX, USA.'}, {'ForeName': 'David I', 'Initials': 'DI', 'LastName': 'Quinn', 'Affiliation': 'Norris Comprehensive Cancer Center, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Evan Y', 'Initials': 'EY', 'LastName': 'Yu', 'Affiliation': 'Division of Oncology, Department of Medicine, University of Washington, Seattle, WA, USA. evanyu@uw.edu.'}]",Prostate cancer and prostatic diseases,['10.1038/s41391-020-0210-x'] 529,32058675,"Efficacy of indoor air purification in the treatment of Artemisia pollen-allergic rhinitis: A randomised, double-blind, clinical controlled trial.","OBJECTIVES To evaluate the clinical efficacy of a high-efficiency air purifier in patients with allergic rhinitis. DESIGN We conducted a randomised, double-blind, clinical controlled trial with active and inactive versions of an air purifier. Our study included patients with allergic rhinitis who were sensitive to Artemisia pollen and treatment of the indoor environment using air filtration at night. We evaluated the clinical efficacy of indoor air filtration during the Artemisia pollen scattering season in Yulin City in Shanxi Province, China. SETTING The First Hospital of Yulin (Yulin City, Shanxi Province, China). PARTICIPANTS A total of 90 patients with allergic rhinitis who were sensitive to allergens of Artemisia pollen were randomly assigned to one of two groups in equal numbers. MAIN OUTCOME MEASURES The primary outcome measure was the difference in visual analogue scale scores from baseline. Secondary outcomes were changes from baseline in nasal symptoms, allergy symptom scores, responses to the Rhinoconjunctivitis Quality of Life Questionnaire, Epworth Sleepiness Scale scores and tolerability scores for the air purifier. RESULTS Based on the allergy symptom score, we found significant differences in rhinitis symptoms between the groups who used the active versus the inactive air purifier. CONCLUSIONS The results of our investigation demonstrated the health benefits of particle filtration.",2020,"Secondary outcomes were changes from baseline in nasal symptoms, allergy symptom scores, responses to the Rhinoconjunctivitis Quality of Life Questionnaire, Epworth Sleepiness Scale scores, and tolerability scores for the air purifier. ","['patients with allergic rhinitis', 'The First Hospital of Yulin', 'patients with allergic rhinitis who were sensitive to Artemisia pollen and treatment of the indoor environment using air filtration at night', 'A total of 90 patients with allergic rhinitis who were sensitive to allergens of Artemisia pollen', 'Yulin City in Shangxi Province, China', 'Artemisia pollen allergic rhinitis']","['indoor air filtration', 'indoor air purification']","['visual analog scale scores', 'changes from baseline in nasal symptoms, allergy symptom scores, responses to the Rhinoconjunctivitis Quality of Life Questionnaire, Epworth Sleepiness Scale scores, and tolerability scores for the air purifier', 'allergy symptom score', 'rhinitis symptoms']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2607914', 'cui_str': 'Rhinitis, Allergic'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0332324', 'cui_str': 'Sensitive (qualifier value)'}, {'cui': 'C4520779', 'cui_str': 'Artemisia pollen (substance)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0016107', 'cui_str': 'Filtration - action'}, {'cui': 'C0240526', 'cui_str': 'Night time (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0002092', 'cui_str': 'Allergens'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}]","[{'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0016107', 'cui_str': 'Filtration - action'}, {'cui': 'C0243114', 'cui_str': 'purification'}]","[{'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0231918', 'cui_str': 'Nasal symptom'}, {'cui': 'C0002111', 'cui_str': 'Allergy Specialty'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0861155', 'cui_str': 'Rhinoconjunctivitis'}, {'cui': 'C0034380'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C4706348', 'cui_str': 'Epworth Sleepiness Scale score (observable entity)'}, {'cui': 'C0262774', 'cui_str': 'Air Purifiers'}, {'cui': 'C0009443', 'cui_str': 'Common Cold'}]",90.0,0.136846,"Secondary outcomes were changes from baseline in nasal symptoms, allergy symptom scores, responses to the Rhinoconjunctivitis Quality of Life Questionnaire, Epworth Sleepiness Scale scores, and tolerability scores for the air purifier. ","[{'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': ""The First Hospital of Yulin, The Second Affiliated Hospital, Yanan University, Yan'an, China.""}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': ""The First Hospital of Yulin, The Second Affiliated Hospital, Yanan University, Yan'an, China.""}, {'ForeName': 'Jin-Han', 'Initials': 'JH', 'LastName': 'Mo', 'Affiliation': 'Beijing Key Laboratory of Indoor Air Quality Evaluation and Control, Tsinghua University, Beijing, China.'}, {'ForeName': 'Yun-Ying', 'Initials': 'YY', 'LastName': 'Li', 'Affiliation': 'Guangdong Provincial Hospital of Chinese Medicine, The Second Affiliated Hospital, Guangzhou University of Chinese Medicine, Guangzhou, China.'}, {'ForeName': 'Ji-Yan', 'Initials': 'JY', 'LastName': 'Xia', 'Affiliation': 'Guangdong Provincial Hospital of Chinese Medicine, The Second Affiliated Hospital, Guangzhou University of Chinese Medicine, Guangzhou, China.'}, {'ForeName': 'Xiao-Bing', 'Initials': 'XB', 'LastName': 'Bai', 'Affiliation': ""The First Hospital of Yulin, The Second Affiliated Hospital, Yanan University, Yan'an, China.""}, {'ForeName': 'Pei-Fang', 'Initials': 'PF', 'LastName': 'Xie', 'Affiliation': 'State Key Laboratory of Respiratory Diseases, Guangzhou Institute of Respiratory Disease, National Clinical Centre of Respiratory Disease, The First Affiliated Hospital, Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Jing-Yi', 'Initials': 'JY', 'LastName': 'Liang', 'Affiliation': 'State Key Laboratory of Respiratory Diseases, Guangzhou Institute of Respiratory Disease, National Clinical Centre of Respiratory Disease, The First Affiliated Hospital, Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Zi-Feng', 'Initials': 'ZF', 'LastName': 'Yang', 'Affiliation': 'State Key Laboratory of Respiratory Diseases, Guangzhou Institute of Respiratory Disease, National Clinical Centre of Respiratory Disease, The First Affiliated Hospital, Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Qiao-Yan', 'Initials': 'QY', 'LastName': 'Chen', 'Affiliation': 'Guangdong Provincial Hospital of Chinese Medicine, The Second Affiliated Hospital, Guangzhou University of Chinese Medicine, Guangzhou, China.'}]",Clinical otolaryngology : official journal of ENT-UK ; official journal of Netherlands Society for Oto-Rhino-Laryngology & Cervico-Facial Surgery,['10.1111/coa.13514'] 530,32115853,A metabolomics-based molecular pathway analysis of how the sodium-glucose co-transporter-2 inhibitor dapagliflozin may slow kidney function decline in patients with diabetes.,"AIM To investigate which metabolic pathways are targeted by the sodium-glucose co-transporter-2 inhibitor dapagliflozin to explore the molecular processes involved in its renal protective effects. METHODS An unbiased mass spectrometry plasma metabolomics assay was performed on baseline and follow-up (week 12) samples from the EFFECT II trial in patients with type 2 diabetes with non-alcoholic fatty liver disease receiving dapagliflozin 10 mg/day (n = 19) or placebo (n = 6). Transcriptomic signatures from tubular compartments were identified from kidney biopsies collected from patients with diabetic kidney disease (DKD) (n = 17) and healthy controls (n = 30) from the European Renal cDNA Biobank. Serum metabolites that significantly changed after 12 weeks of dapagliflozin were mapped to a metabolite-protein interaction network. These proteins were then linked with intra-renal transcripts that were associated with DKD or estimated glomerular filtration rate (eGFR). The impacted metabolites and their protein-coding transcripts were analysed for enriched pathways. RESULTS Of all measured (n = 812) metabolites, 108 changed (P < 0.05) during dapagliflozin treatment and 74 could be linked to 367 unique proteins/genes. Intra-renal mRNA expression analysis of the genes encoding the metabolite-associated proteins using kidney biopsies resulted in 105 genes that were significantly associated with eGFR in patients with DKD, and 135 genes that were differentially expressed between patients with DKD and controls. The combination of metabolites and transcripts identified four enriched pathways that were affected by dapagliflozin and associated with eGFR: glycine degradation (mitochondrial function), TCA cycle II (energy metabolism), L-carnitine biosynthesis (energy metabolism) and superpathway of citrulline metabolism (nitric oxide synthase and endothelial function). CONCLUSION The observed molecular pathways targeted by dapagliflozin and associated with DKD suggest that modifying molecular processes related to energy metabolism, mitochondrial function and endothelial function may contribute to its renal protective effect.",2020,108 changed (p<0.05) during dapagliflozin treatment and 74 could be linked to 367 unique proteins/genes.,"['patients with diabetes', 'diabetic kidney disease (DKD', 'n=6) Transcriptomic signatures from tubular compartments were identified from kidney biopsies collected from patients with DKD (n=17) and healthy controls (n=30) from the European Renal cDNA Biobank (ERCB', 'type 2 diabetes patients with non-alcoholic fatty liver disease receiving']","['placebo', 'dapagliflozin']",['Serum metabolites'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0011881', 'cui_str': 'Diabetic Nephropathy'}, {'cui': 'C0332208', 'cui_str': 'Tubular (qualifier value)'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0194073', 'cui_str': 'Kidney biopsy (procedure)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0239307', 'cui_str': 'European (ethnic group)'}, {'cui': 'C0006556', 'cui_str': 'cDNA'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0400966', 'cui_str': 'NAFLD'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2353951', 'cui_str': 'dapagliflozin'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}]",,0.0506005,108 changed (p<0.05) during dapagliflozin treatment and 74 could be linked to 367 unique proteins/genes.,"[{'ForeName': 'Skander', 'Initials': 'S', 'LastName': 'Mulder', 'Affiliation': 'Department of Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Hammarstedt', 'Affiliation': 'AstraZeneca, BioPharmaceuticals R&D, Mölndal, Sweden.'}, {'ForeName': 'Sunil B', 'Initials': 'SB', 'LastName': 'Nagaraj', 'Affiliation': 'Department of Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Viji', 'Initials': 'V', 'LastName': 'Nair', 'Affiliation': 'Michigan University, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Wenjun', 'Initials': 'W', 'LastName': 'Ju', 'Affiliation': 'Michigan University, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Jonatan', 'Initials': 'J', 'LastName': 'Hedberg', 'Affiliation': 'AstraZeneca, BioPharmaceuticals R&D, Mölndal, Sweden.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Greasley', 'Affiliation': 'AstraZeneca, BioPharmaceuticals R&D, Mölndal, Sweden.'}, {'ForeName': 'Jan W', 'Initials': 'JW', 'LastName': 'Eriksson', 'Affiliation': 'Department of Medical Sciences, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Oscarsson', 'Affiliation': 'AstraZeneca, BioPharmaceuticals R&D, Mölndal, Sweden.'}, {'ForeName': 'Hiddo J L', 'Initials': 'HJL', 'LastName': 'Heerspink', 'Affiliation': 'Department of Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands.'}]","Diabetes, obesity & metabolism",['10.1111/dom.14018'] 531,32209015,Immunogenicity and safety of a booster dose of a quadrivalent meningococcal tetanus toxoid-conjugate vaccine (MenACYW-TT) in adolescents and adults: a Phase III randomized study.,"The quadrivalent meningococcal tetanus toxoid-conjugate vaccine (MenACYW-TT) was assessed as a booster in this Phase III trial (NCT02752906). Quadrivalent meningococcal conjugate vaccine (MCV4)-primed individuals aged ≥15 y (n = 810) were randomized 1:1 to receive a single booster dose of MenACYW-TT (n = 403) or a licensed MCV4 (Menactra®; MCV4-DT [n = 407]). Serum bactericidal antibody assay with human complement (hSBA) was used to measure functional antibodies against serogroups A, C, W, and Y at baseline and Day 30 post-vaccination. Proportions of participants achieving seroresponse (post-vaccination titer ≥1:16 for those with baseline titer <1:8 or ≥4-fold increase in post-vaccination titer for those with baseline titer ≥1:8) were determined. Safety data were collected for 180 d post-vaccination. Non-inferiority of the immune response was demonstrated for MenACYW-TT compared with MCV4-DT based on the proportion of participants achieving hSBA vaccine seroresponse for each of the meningococcal serogroups at Day 30. Moreover, ≥99% of participants in both study groups had hSBA titers ≥1:8 for the four meningococcal serogroups at Day 30. Reactogenicity profiles were comparable between groups. These Phase III data in adolescents and adults show that MenACYW-TT boosts the immune response in those primed with MCV4 vaccines 4-10 y previously, irrespective of whether MCV4-DT or MCV4-CRM was used for priming.",2020,inferiority of the immune response was demonstrated for MenACYW-TT compared with MCV4-DT based on the proportion of participants achieving hSBA vaccine seroresponse for each of the meningococcal serogroups at Day 30.,"['Quadrivalent meningococcal conjugate vaccine (MCV4)-primed individuals aged ≥15\xa0y (n\xa0=\xa0810', 'adolescents and adults']","['single booster dose of MenACYW-TT', 'quadrivalent meningococcal tetanus toxoid-conjugate vaccine (MenACYW-TT', 'MCV4-DT or MCV4-CRM', 'MCV4-DT', 'licensed MCV4 (Menactra®; MCV4-DT']","['Immunogenicity and safety', 'Reactogenicity profiles', 'hSBA titers']","[{'cui': 'C1660580', 'cui_str': 'Meningococcal conjugate vaccine'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C1697762', 'cui_str': 'Booster'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0305062', 'cui_str': 'Clostridium tetani toxoid antigen, inactivated'}, {'cui': 'C0206515', 'cui_str': 'Vaccines, Conjugate'}, {'cui': 'C1567129', 'cui_str': 'Menactra'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0475208', 'cui_str': 'TITR'}]",810.0,0.186252,inferiority of the immune response was demonstrated for MenACYW-TT compared with MCV4-DT based on the proportion of participants achieving hSBA vaccine seroresponse for each of the meningococcal serogroups at Day 30.,"[{'ForeName': 'Germán', 'Initials': 'G', 'LastName': 'Áñez', 'Affiliation': 'Global Clinical Sciences, Sanofi Pasteur , Swiftwater, PA, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Hedrick', 'Affiliation': 'Kentucky Pediatric/Adult Research , Bardstown, KY, USA.'}, {'ForeName': 'Michael W', 'Initials': 'MW', 'LastName': 'Simon', 'Affiliation': 'Private Practice , Nicholasville, KY, USA.'}, {'ForeName': 'Shane', 'Initials': 'S', 'LastName': 'Christensen', 'Affiliation': 'J. Lewis Research , Salt Lake City, UT, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Jeanfreau', 'Affiliation': 'MedPharmics , Metairie, LA, USA.'}, {'ForeName': 'Eddy', 'Initials': 'E', 'LastName': 'Yau', 'Affiliation': 'Global Biostatistical Sciences, Sanofi Pasteur , Toronto, ON, Canada.'}, {'ForeName': 'Judy', 'Initials': 'J', 'LastName': 'Pan', 'Affiliation': 'Global Biostatistical Sciences, Sanofi Pasteur , Swiftwater, PA, USA.'}, {'ForeName': 'Emilia', 'Initials': 'E', 'LastName': 'Jordanov', 'Affiliation': 'Global Clinical Sciences, Sanofi Pasteur , Swiftwater, PA, USA.'}, {'ForeName': 'Mandeep S', 'Initials': 'MS', 'LastName': 'Dhingra', 'Affiliation': 'Global Clinical Sciences, Sanofi Pasteur , Swiftwater, PA, USA.'}]",Human vaccines & immunotherapeutics,['10.1080/21645515.2020.1733867'] 532,31229618,Rationale and design of an integrated bio-behavioral approach to improve adherence to pre-exposure prophylaxis and HIV risk reduction among opioid-dependent people who use drugs: The CHRP-BB study.,"BACKGROUND Few primary HIV prevention strategies have successfully integrated both behavioral and biomedical components, with modest HIV risk reduction outcomes among opioid-dependent people who use drugs (PWUD). In response to this unmet need, we developed a brief, bio-behavioral intervention to simultaneously promote PrEP adherence and reduce HIV risk among opioid-dependent PWUD. METHODS Using a Hybrid Type I implementation science design, we will examine the efficacy of the integrated bio-behavioral, Community-friendly Health Recovery Program (CHRP-BB) compared to a time-and-attention matched control condition among HIV-negative, opioid-dependent PWUD who are prescribed PrEP and enrolled in a methadone maintenance program (MMP) using a randomized controlled trial (RCT). Participants are assessed at baseline, immediately post-intervention (8 weeks) and follow-ups at weeks 20, 32, and 44 post-intervention. The primary outcome is biomedical (PrEP adherence), with secondary outcomes including behavioral (self-reported drug- and sex-related HIV risk behaviors), ongoing drug use (confirmed with urine drug testing), and related domains of the theoretical information-motivation-behavioral skills (IMB) model of behavior change related to PrEP adherence and HIV-transmission-risk reduction. Additionally, we will conduct a process evaluation of delivery/implementation of the intervention to collect valuable information to be used in future implementation. CONCLUSIONS This study will be among the first prospective trial to test an integrated bio-behavioral intervention to improve adherence to PrEP and HIV risk reduction among opioid-dependent PWUD.",2019,"BACKGROUND Few primary HIV prevention strategies have successfully integrated both behavioral and biomedical components, with modest HIV risk reduction outcomes among opioid-dependent people who use drugs (PWUD).","['Using a Hybrid Type', 'HIV-negative, opioid-dependent PWUD who are prescribed PrEP and enrolled in a methadone maintenance program (MMP']","['integrated bio-behavioral intervention', 'integrated bio-behavioral approach', 'integrated bio-behavioral, Community-friendly Health Recovery Program (CHRP-BB']","['biomedical (PrEP adherence), with secondary outcomes including behavioral (self-reported drug- and sex-related HIV risk behaviors), ongoing drug use (confirmed with urine drug testing), and related domains of the theoretical information-motivation-behavioral skills (IMB) model of behavior change related to PrEP adherence and HIV-transmission-risk reduction', 'adherence to PrEP and HIV risk reduction']","[{'cui': 'C0020205', 'cui_str': 'Hybrids'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0481430', 'cui_str': 'HTLV-3 antibody negative'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}, {'cui': 'C0025605', 'cui_str': 'Methadone'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0623362', 'cui_str': 'MMPs'}]","[{'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0086931', 'cui_str': 'Risk Behavior'}, {'cui': 'C0449889', 'cui_str': 'Drug used (attribute)'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0042037'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0040722', 'cui_str': 'transmission'}, {'cui': 'C1137094', 'cui_str': 'Risk Reduction'}]",,0.0525199,"BACKGROUND Few primary HIV prevention strategies have successfully integrated both behavioral and biomedical components, with modest HIV risk reduction outcomes among opioid-dependent people who use drugs (PWUD).","[{'ForeName': 'Roman', 'Initials': 'R', 'LastName': 'Shrestha', 'Affiliation': 'Section of Infectious Diseases, AIDS Program, Yale University School of Medicine, New Haven, CT, USA. Electronic address: roman.shrestha@yale.edu.'}, {'ForeName': 'Frederick L', 'Initials': 'FL', 'LastName': 'Altice', 'Affiliation': 'Section of Infectious Diseases, AIDS Program, Yale University School of Medicine, New Haven, CT, USA; Division of Epidemiology of Microbial Diseases, Yale University School of Public Health, New Haven, CT, USA.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Sibilio', 'Affiliation': 'Department of Allied Health Sciences, University of Connecticut, Storrs, CT, USA.'}, {'ForeName': 'Jude', 'Initials': 'J', 'LastName': 'Ssenyonjo', 'Affiliation': 'Department of Allied Health Sciences, University of Connecticut, Storrs, CT, USA.'}, {'ForeName': 'Michael M', 'Initials': 'MM', 'LastName': 'Copenhaver', 'Affiliation': 'Department of Allied Health Sciences, University of Connecticut, Storrs, CT, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2019.06.012'] 533,31233478,Strengths and Limitations of a Small Randomized Trial Comparing Manual and Vacuum Drainage in Thoracentesis.,,2019,,[],['Manual and Vacuum Drainage'],[],[],"[{'cui': 'C0175674', 'cui_str': 'Manual (qualifier value)'}, {'cui': 'C0042221', 'cui_str': 'Vacuum'}, {'cui': 'C0013103', 'cui_str': 'Drainage'}]",[],,0.115838,,"[{'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Senitko', 'Affiliation': 'Division of Pulmonary, Critical Care and Sleep Medicine, University of Mississippi Medical Center School of Medicine Jackson, MS.'}, {'ForeName': 'Terrence E', 'Initials': 'TE', 'LastName': 'Murphy', 'Affiliation': 'Claude D. Pepper Older Americans Independence Center at Yale, Program on Aging, Yale School of Medicine New Haven, CT.'}, {'ForeName': 'Jonathan T', 'Initials': 'JT', 'LastName': 'Puchalski', 'Affiliation': 'Division of Pulmonary Critical Care and Sleep Medicine Yale University School of Medicine.'}]",Journal of bronchology & interventional pulmonology,['10.1097/LBR.0000000000000583'] 534,31679747,A Walking Intervention to Increase Weekly Steps in Dialysis Patients: A Pilot Randomized Controlled Trial.,"RATIONALE & OBJECTIVE Patients receiving dialysis report very low physical activity. We implemented a pilot trial to assess the feasibility of a pedometer-based intervention to gather preliminary evidence about its impact on physical activity, symptoms, and surrogates of cardiovascular risk. STUDY DESIGN Pilot randomized controlled trial. SETTING & PARTICIPANTS 60 dialysis patients from San Francisco dialysis clinics. INTERVENTION Participants were randomly assigned 1:1 to receiving pedometers with weekly step goals or usual care for 3 months. OUTCOMES The primary outcome was step counts, measured using pedometers. Secondary outcomes included physical performance using the Short Physical Performance Battery, the Physical Function and Vitality scales of the 36-Item Short Form Health Survey, the Dialysis Symptoms Index, and the Center for Epidemiologic Studies-Depression Scale, with endothelial function as a secondary and heart rate variability as an exploratory surrogate measure of cardiovascular risk. Targeted enrollment was 50% and targeted completion was 85%. RESULTS 49% of approached patients were enrolled, and 92% completed the study. After 3 months, patients randomly assigned to the intervention (n=30) increased their average daily steps by 2,256 (95% CI, 978-3,537) more than the 30 controls (P<0.001). Heart rate variability (standard deviation of N-N intervals) increased by 14.94 (95% CI, 0.31-33.56) millisecondsin the intervention group as compared with controls (P = 0.05). There were no statistically significant differences across intervention groups in symptoms, physical performance, or endothelial function. Participants in the intervention group reverted to baseline steps during the postintervention follow-up. LIMITATIONS The Northern California study setting may limit generalizability. Walking does not capture the full spectrum of physical activity. CONCLUSIONS A short-term pedometer-based intervention led to increased step counts in dialysis patients, but the increase was not sustained. Pedometer-based interventions are feasible for dialysis patients, but future studies are needed to address whether more prolonged interventions can improve physical function or symptoms. FUNDING Supported by grants from the American Kidney Fund, National Institutes of Health-National Institute of Diabetes and Digestive and Kidney Diseases, and International Society of Nephrology. TRIAL REGISTRATION Registered at ClinicalTrials.gov with study identifier NCT02623348.",2020,"Heart rate variability (standard deviation of N-N intervals) increased by 14.94 (95% CI, 0.31-33.56) millisecondsin the intervention group as compared with controls (P = 0.05).","['Patients receiving dialysis report very low physical activity', 'Dialysis Patients', '60 dialysis patients from San Francisco dialysis clinics']","['receiving pedometers with weekly step goals or usual care for 3 months', 'Walking Intervention', 'pedometer-based intervention']","['physical activity, symptoms, and surrogates of cardiovascular risk', 'physical performance using the Short Physical Performance Battery, the Physical Function and Vitality scales of the 36-Item Short Form Health Survey, the Dialysis Symptoms Index, and the Center for Epidemiologic Studies-Depression Scale, with endothelial function as a secondary and heart rate variability as an exploratory surrogate measure of cardiovascular risk', 'symptoms, physical performance, or endothelial function', 'Heart rate variability (standard deviation of N-N intervals']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4551529', 'cui_str': 'Renal Dialysis'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0442811', 'cui_str': 'Very low (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0036152', 'cui_str': 'San Francisco'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}]","[{'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0018017', 'cui_str': 'Goals'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C2607857'}, {'cui': 'C4075461', 'cui_str': 'Short Physical Performance Battery'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0222045'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C4551529', 'cui_str': 'Renal Dialysis'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C1272706', 'cui_str': 'Interval'}]",,0.118622,"Heart rate variability (standard deviation of N-N intervals) increased by 14.94 (95% CI, 0.31-33.56) millisecondsin the intervention group as compared with controls (P = 0.05).","[{'ForeName': 'Anoop', 'Initials': 'A', 'LastName': 'Sheshadri', 'Affiliation': 'Division of Nephrology, University of California, San Francisco, San Francisco, CA. Electronic address: anoop.sheshadri@ucsf.edu.'}, {'ForeName': 'Piyawan', 'Initials': 'P', 'LastName': 'Kittiskulnam', 'Affiliation': 'Division of Internal Medicine-Nephrology, Chulalongkorn University, Bangkok, Thailand; Special Task Force for Activating Research in Renal Nutrition, (Renal Nutrition Research Group), Office of Research Affairs, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Ann A', 'Initials': 'AA', 'LastName': 'Lazar', 'Affiliation': 'Department of Epidemiology and Biostatistics, University of California, San Francisco, San Francisco, CA.'}, {'ForeName': 'Kirsten L', 'Initials': 'KL', 'LastName': 'Johansen', 'Affiliation': 'Division of Nephrology, University of California, San Francisco, San Francisco, CA.'}]",American journal of kidney diseases : the official journal of the National Kidney Foundation,['10.1053/j.ajkd.2019.07.026'] 535,30763527,Titanium Lag Screw Versus Miniplate Fixation in the Treatment of Anterior Mandibular Fractures.,"PURPOSE The use of plates for open reduction and internal fixation of mandibular fractures has become a widely accepted method in the past 3 decades. However, the anterior mandible is well suited to lag screw fixation owing to the thickness of its bony cortices. Hence, the purpose of the present study was to comparatively evaluate clinical outcomes of fixation using lag screws and miniplates in anterior mandibular fractures. PATIENTS AND METHODS Fifty patients reporting to the department of oral and maxillofacial surgery with noncomminuted anterior mandibular fractures were randomly divided into 2 groups of 25 patients each. Patients in group A were treated with 2.5-mm lag screws 22 to 26 mm in length and those in group B were treated with 2.0-mm 4-hole miniplates with a gap using monocortical screws. Subsequent follow-up was performed at 3, 6, 12, and 24 weeks postoperatively. The primary determinants included radiographic analysis of the fracture gap and biting efficiency of the patients in groups A and B. The secondary determinants included evaluation of duration of surgery, occlusion before and after injury, and postoperative complications. Results were evaluated using χ 2 and unpaired t tests. RESULTS The mean age of the patients in this study was 29.1 ± 8.32 years (range, 18 to 67 yr). The mean postoperative fracture gap was considerably larger in group B. The mean duration of surgery (minutes) was 37.60 ± 9.30 for group A and 47 ± 6.55 for group B. The difference was statistically significant (P = .001). The lag screw group showed faster improvement in biting efficiency compared with the miniplate group. CONCLUSIONS Lag screw fixation was found to have good stability and rigidity, was inexpensive, and was less time consuming in treating anterior mandibular fractures compared with miniplates.",2019,The mean postoperative fracture gap was considerably larger in group,"['Fifty patients reporting to the department of oral and maxillofacial surgery with noncomminuted anterior mandibular fractures', 'Anterior Mandibular Fractures', 'The mean age of the patients in this study was 29.1\xa0±\xa08.32\xa0years (range, 18 to 67\xa0yr']","['2.5-mm lag screws 22 to 26\xa0mm in length and those in group B were treated with 2.0-mm 4-hole miniplates with a gap using monocortical screws', 'Lag screw fixation', 'Titanium Lag Screw Versus Miniplate Fixation']","['radiographic analysis of the fracture gap and biting efficiency', 'biting efficiency', 'evaluation of duration of surgery, occlusion before and after injury, and postoperative complications', 'mean duration of surgery', 'mean postoperative fracture gap']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0812928', 'cui_str': 'Oral and maxillofacial surgery'}, {'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C0024692', 'cui_str': 'Mandibular Fractures'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}]","[{'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0301559', 'cui_str': 'Screw (physical object)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0441836', 'cui_str': 'Group B (qualifier value)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C0040302', 'cui_str': 'Titanium'}]","[{'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0005658', 'cui_str': 'Bites'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0441597', 'cui_str': 'Occlusion - action (qualifier value)'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}]",50.0,0.0158749,The mean postoperative fracture gap was considerably larger in group,"[{'ForeName': 'Manish', 'Initials': 'M', 'LastName': 'Tiwari', 'Affiliation': 'Fellow, Department of Oral and Maxillofacial Surgery, SDKS Dental College, Nagpur, India; Fellow, Oral Oncology, Park Clinic, Kolkata, West Bengal, India. Electronic address: drmanishstiwari@gmail.com.'}, {'ForeName': 'Vikas', 'Initials': 'V', 'LastName': 'Meshram', 'Affiliation': 'Associate Professor, Department of Oral and Maxillofacial Surgery, Government Dental College, Mumbai, India.'}, {'ForeName': 'Pravin', 'Initials': 'P', 'LastName': 'Lambade', 'Affiliation': 'Consultant Oral and Maxillofacial Surgeon and Former Head of Department, Oral and Maxillofacial Surgery, SDKS Dental College, Nagpur, India.'}, {'ForeName': 'Gabriela', 'Initials': 'G', 'LastName': 'Fernandes', 'Affiliation': 'Resident and Postdoctoral Researcher, Departments of Periodontics and Endodontics and Oral Biology, School of Dental Medicine, SUNY Buffalo, Buffalo, NY.'}]",Journal of oral and maxillofacial surgery : official journal of the American Association of Oral and Maxillofacial Surgeons,['10.1016/j.joms.2019.01.001'] 536,30796907,Locking Miniplate Osteosynthesis of Anterior Mandibular Fractures-Quo Vadis?,"PURPOSE This study compared the clinical stability and efficacy of locking miniplates with those of standard miniplates in the osteosynthesis of anterior mandibular fractures using bite force recordings and other clinical parameters. MATERIALS AND METHODS A prospective randomized double-blinded clinical trial was carried out in patients from various hospitals of Hassan (India). Patients were randomly divided into 2 groups of locking (test) and standard (control) miniplate osteosynthesis. Bite force measurements were performed preoperatively and postoperatively at weekly intervals for 6 weeks using a bite force recorder. As a secondary outcome, patients also were assessed for other clinical parameters that might interfere with successful osteosynthesis at the fracture site. Appropriate statistical testing for intra- and intergroup measurements was carried out. RESULTS Forty-eight men 28 ± 12.3 years old met the inclusion criteria (24 patients in each group). A statistically significant difference (P < .05) was found in the incisor bite force between the 2 groups, with values in the locking group exceeding those in the standard group at postoperative weeks 2 and 5. Duration of surgery was shorter in the locking group (P = .015). No relevant difference was found for the other clinical parameters. CONCLUSIONS Bite force statistically increased at progressive follow-up visits compared with the preoperative recording in the locking group. Bite force recordings of patients treated with locking plates were higher and statistically relevant compared with those of patients treated with standard miniplates at the incisor region at postoperative weeks 2 and 5. The clinical outcomes of the 2 miniplate systems in the present study were similar; however, the locking miniplates required a relatively shorter operating time, produced less trauma to the periosteum and soft tissues with less hardware, and can be used as a ""1-plate-for-all"" system.",2019,Bite force recordings of patients treated with locking plates were higher and statistically relevant compared with those of patients treated with standard miniplates at the incisor region at postoperative weeks 2 and 5.,"['12.3\xa0years old met the inclusion criteria (24 patients in each group', 'Forty-eight men 28\xa0±', 'patients from various hospitals of Hassan (India']","['locking miniplates', 'locking (test) and standard (control) miniplate osteosynthesis', 'Locking Miniplate Osteosynthesis']","['Duration of surgery', 'incisor bite force', 'Bite force recordings']","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4319608', 'cui_str': 'Forty-eight'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0021201', 'cui_str': 'Republic of India'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0016642', 'cui_str': 'Osteosynthesis, Fracture'}]","[{'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0021156', 'cui_str': 'Incisor'}, {'cui': 'C0005654', 'cui_str': 'Occlusal Force'}]",,0.0313745,Bite force recordings of patients treated with locking plates were higher and statistically relevant compared with those of patients treated with standard miniplates at the incisor region at postoperative weeks 2 and 5.,"[{'ForeName': 'Vyoma', 'Initials': 'V', 'LastName': 'Desai', 'Affiliation': 'Former Senior Resident, Department of Oral and Maxillofacial Surgery, Sri Hasanamba Dental College and Hospital, Hassan, Karnataka, India.'}, {'ForeName': 'Manoj Kumar', 'Initials': 'MK', 'LastName': 'Jain', 'Affiliation': 'Former Associate Professor, Department of Oral and Maxillofacial Surgery, Sri Hasanamba Dental College and Hospital, Hassan, Karnataka, India. Electronic address: lovingjain15@yahoo.com.'}]",Journal of oral and maxillofacial surgery : official journal of the American Association of Oral and Maxillofacial Surgeons,['10.1016/j.joms.2019.01.029'] 537,32402732,Transversus abdominis plane block with liposomal bupivacaine and its effect on opiate use after weight loss surgery: a randomized controlled trial.,"BACKGROUND Liposomal bupivacaine (LB), as an extended-release local anesthetic, may provide lasting pain control and therefore decrease the need for narcotics in the immediate postoperative period. OBJECTIVES The aim of this study was to evaluate whether transversus abdominis plane (TAP) block with LB decreased the use of postoperative narcotics compared with regular bupivacaine (RB) and no TAP block in patients undergoing weight loss procedures. SETTING A large, metropolitan, university-affiliated, tertiary hospital. METHODS Patients undergoing laparoscopic Roux-en-Y gastric bypass, sleeve gastrectomy, or sleeve-to-bypass conversion over 1 year were randomized to receive TAP block using LB, TAP block with RB, or no block in a double-blind, randomized controlled trial. The outcomes measured were postoperative use of opiates, pain score, length of stay, time to ambulation, and nausea. Data were analyzed using χ 2 test and analysis of variance F test. RESULTS Two hundred nineteen patients were included in the study. Fentanyl patient-controlled analgesia usage was not significantly different between the groups (LB 351.4 versus RB 360.7 versus no TAP block 353.9, P = .97) at 48 hours post operation. The pain scores (scale 1-10) were similar among the groups with the mean for the LB group at 4.3, and RB and no TAP block groups both at 4.7 (P = .35). The type of block or lack of block did not significantly impact the length of stay, time to ambulation, or presence of nausea. CONCLUSION The LB TAP block did not significantly reduce the total opiate pain medication consumption nor did it reduce pain scores among bariatric surgery patients.",2020,The LB TAP block did not significantly reduce the total opiate pain medication consumption nor did it reduce pain scores among bariatric surgery patients.,"['A large, metropolitan, university-affiliated, tertiary hospital', 'opiate use after weight loss surgery', 'patients undergoing weight loss procedures', 'Two hundred nineteen patients were included in the study', 'Patients undergoing laparoscopic Roux-en-Y gastric bypass, sleeve gastrectomy, or sleeve-to-bypass conversion over 1 year']","['transversus abdominis plane (TAP) block with LB', 'regular bupivacaine (RB) and no TAP block', 'Liposomal bupivacaine (LB', 'TAP block using LB, TAP block with RB, or no block', 'liposomal bupivacaine']","['Fentanyl patient-controlled analgesia usage', 'pain scores', 'length of stay, time to ambulation, or presence of nausea', 'postoperative use of opiates, pain score, length of stay, time to ambulation, and nausea', 'total opiate pain medication consumption']","[{'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0242401', 'cui_str': 'Opiates'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C1456587', 'cui_str': 'Metabolic surgery'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0450337', 'cui_str': '19'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0399839', 'cui_str': 'Bypass gastrojejunostomy'}, {'cui': 'C3160799', 'cui_str': 'Sleeve gastrectomy'}, {'cui': 'C0183336', 'cui_str': 'Sleeve'}, {'cui': 'C0741847', 'cui_str': 'Bypass'}, {'cui': 'C0439836', 'cui_str': 'Conversions'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0023828', 'cui_str': 'Liposomes'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0205272', 'cui_str': 'Regular'}]","[{'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0078944', 'cui_str': 'Patient controlled analgesia'}, {'cui': 'C0457083', 'cui_str': 'Usage'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0242401', 'cui_str': 'Opiates'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]",219.0,0.208823,The LB TAP block did not significantly reduce the total opiate pain medication consumption nor did it reduce pain scores among bariatric surgery patients.,"[{'ForeName': 'Kristen A', 'Initials': 'KA', 'LastName': 'Wong', 'Affiliation': 'Department of Surgery, Montefiore Medical Center/Albert Einstein College of Medicine, Bronx, New York.'}, {'ForeName': 'Ana Garcia', 'Initials': 'AG', 'LastName': 'Cabrera', 'Affiliation': 'Department of Surgery, Montefiore Medical Center/Albert Einstein College of Medicine, Bronx, New York.'}, {'ForeName': 'Alexandra L', 'Initials': 'AL', 'LastName': 'Argiroff', 'Affiliation': 'Department of Surgery, Montefiore Medical Center/Albert Einstein College of Medicine, Bronx, New York.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Pechman', 'Affiliation': 'Department of Surgery, Montefiore Medical Center/Albert Einstein College of Medicine, Bronx, New York.'}, {'ForeName': 'Michael K', 'Initials': 'MK', 'LastName': 'Parides', 'Affiliation': 'Department of Surgery, Montefiore Medical Center/Albert Einstein College of Medicine, Bronx, New York; Department of Epidemiology and Population Health, Albert Einstein College of Medicine, Bronx, New York.'}, {'ForeName': 'Joseph T', 'Initials': 'JT', 'LastName': 'Vazzana', 'Affiliation': 'Department of Surgery, Montefiore Medical Center/Albert Einstein College of Medicine, Bronx, New York.'}, {'ForeName': 'Erin M', 'Initials': 'EM', 'LastName': 'Moran-Atkin', 'Affiliation': 'Department of Surgery, Montefiore Medical Center/Albert Einstein College of Medicine, Bronx, New York.'}, {'ForeName': 'Jenny J', 'Initials': 'JJ', 'LastName': 'Choi', 'Affiliation': 'Department of Surgery, Montefiore Medical Center/Albert Einstein College of Medicine, Bronx, New York.'}, {'ForeName': 'Diego R', 'Initials': 'DR', 'LastName': 'Camacho', 'Affiliation': 'Department of Surgery, Montefiore Medical Center/Albert Einstein College of Medicine, Bronx, New York. Electronic address: Dicamach@montefiore.org.'}]",Surgery for obesity and related diseases : official journal of the American Society for Bariatric Surgery,['10.1016/j.soard.2020.03.031'] 538,32405121,Does moral reasoning influence public values for health care priority setting?: A population-based randomized stated preference survey.,"OBJECTIVE Preferences of members of the public are recognized as important inputs into health care priority-setting, though knowledge of such preferences is scant. We sought to generate evidence of public preferences related to healthcare resource allocation among adults and children. METHODS We conducted an experimental stated preference survey in a national sample of Canadian adults. Preferences were elicited across a range of scenarios and scored on a visual analogue scale. Intervention group participants were randomized to a moral reasoning exercise prior to each choice task. The main outcomes were the differences in mean preference scores by group, scenario, and demographics. RESULTS Our results demonstrate a consistent preference by participants to allocate scarce health system resources to children. Exposure to the moral reasoning exercise weakened but did not eliminate this preference. Younger respondent age and parenthood were associated with greater preference for children. The top principles guiding participants' allocative decisions were treat equally, relieve suffering, and rescue those at risk of dying. CONCLUSIONS Our study affirms the relevance of age in public preferences for the allocation of scarce health care resources, demonstrating a significant preference by participants to allocate healthcare resources to children. However, this preference diminishes when challenged by exposure to a range of moral principles, revealing a strong public endorsement of equality of access. Definitions of value in healthcare based on clinical benefit and cost-effectiveness may exclude moral considerations that the public values, such as equality and humanitarianism, highlighting opportunities to enrich healthcare priority-setting through public engagement.",2020,"However, this preference diminishes when challenged by exposure to a range of moral principles, revealing a strong public endorsement of equality of access.","['experimental stated preference survey in a national sample of Canadian adults', 'adults and children']","['moral reasoning exercise', 'moral reasoning exercise prior to each choice task']","['mean preference scores by group, scenario, and demographics']","[{'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0558295', 'cui_str': 'Preferences'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0026531', 'cui_str': 'Morality'}, {'cui': 'C0684328', 'cui_str': 'Reasoning'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0558295', 'cui_str': 'Preferences'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}]",,0.0701692,"However, this preference diminishes when challenged by exposure to a range of moral principles, revealing a strong public endorsement of equality of access.","[{'ForeName': 'Avram E', 'Initials': 'AE', 'LastName': 'Denburg', 'Affiliation': 'Department of Paediatrics, The Hospital for Sick Children, University of Toronto, Toronto, M5G 1X8, Canada. Electronic address: avram.denburg@sickkids.ca.'}, {'ForeName': 'Wendy J', 'Initials': 'WJ', 'LastName': 'Ungar', 'Affiliation': 'Institute of Health Policy, Management, and Evaluation, University of Toronto, Toronto, M5T 3M6, Canada.'}, {'ForeName': 'Shiyi', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': 'Biostatistician, Biostatistics, Design and Analysis, Peter Gilgan Centre for Research and Learning, The Hospital for Sick Children, Toronto, M5G 1X8, Canada.'}, {'ForeName': 'Jeremiah', 'Initials': 'J', 'LastName': 'Hurley', 'Affiliation': 'Department of Economics, McMaster University, Hamilton, L8S 4L8, Canada.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Abelson', 'Affiliation': 'Department of Health Research Methods, Evidence and Impact, McMaster University, Hamilton, L8S 4L8, Canada.'}]","Health policy (Amsterdam, Netherlands)",['10.1016/j.healthpol.2020.04.007'] 539,32046418,An Integrated Efficacy and Safety Analysis of Single-Dose Secnidazole 2 g in the Treatment of Bacterial Vaginosis.,"Bacterial vaginosis (BV) is the most common gynecologic infection in women aged 14 to 49 years. Currently recommended treatments require extended dosing and are thus associated with poor adherence. A single-dose oral granule formulation of secnidazole 2 g (SOLOSEC™ [secnidazole], Symbiomix Therapeutics, a Lupin company, Baltimore, MD), a 5-nitroimidazole antibiotic with antimicrobial activity, has been approved by the US Food and Drug Administration for the treatment of BV in adult women. As part of the US registration package, two randomized, double-blind, placebo-controlled clinical studies were conducted to confirm the efficacy and safety of a novel single-dose oral formulation of secnidazole 2 g. This is an integrated analysis of efficacy and safety results from these studies, pivotal study 1 and pivotal study 2. By combining the results of the two studies, relevant information is presented especially when considering the effect of secnidazole on patients with recurrent episodes of BV and the difference in effect on patients of black race. Single-dose secnidazole 2 g was statistically superior to placebo on all primary and secondary efficacy outcomes in both trials, including clinical outcome responder rate (P < 0.001), achievement of Nugent scores in the normal range of 0 to 3 (P < 0.001), greater numbers of patients as therapeutic outcome responders at the test of cure/end of study visit on days 21-30 (P < 0.001), and fewer patients requiring additional treatment at the test of cure/end of study visit (P < 0.001), supporting the role for single oral dose secnidazole 2 g granules as treatment for women with BV.",2020,"g was statistically superior to placebo on all primary and secondary efficacy outcomes in both trials, including clinical outcome responder rate (P < 0.001), achievement of Nugent scores in the normal range of 0 to 3 (P < 0.001), greater numbers of patients as therapeutic outcome responders at the test of cure/end of study visit on days 21-30 (P < 0.001), and fewer patients requiring additional treatment at the test of cure/end of study visit (P < 0.001), supporting the role for single oral dose secnidazole 2 g granules as treatment for women with BV.","['women aged 14 to 49\xa0years', 'Bacterial Vaginosis', 'women with BV', 'adult women']","['placebo', 'secnidazole 2', 'Single-Dose Secnidazole', 'secnidazole']","['Bacterial vaginosis (BV', 'achievement of Nugent scores', 'clinical outcome responder rate', 'efficacy and safety']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0085166', 'cui_str': 'Vaginitis, Nonspecific'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0074246', 'cui_str': 'secnidazole'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}]","[{'cui': 'C0085166', 'cui_str': 'Vaginitis, Nonspecific'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.140457,"g was statistically superior to placebo on all primary and secondary efficacy outcomes in both trials, including clinical outcome responder rate (P < 0.001), achievement of Nugent scores in the normal range of 0 to 3 (P < 0.001), greater numbers of patients as therapeutic outcome responders at the test of cure/end of study visit on days 21-30 (P < 0.001), and fewer patients requiring additional treatment at the test of cure/end of study visit (P < 0.001), supporting the role for single oral dose secnidazole 2 g granules as treatment for women with BV.","[{'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Pentikis', 'Affiliation': 'Symbiomix Therapeutics, LLC, 1101 E 33rd St, Suite E306, Baltimore, MD, 21218, USA. helenpentikis@lupin.com.'}, {'ForeName': 'Nikki', 'Initials': 'N', 'LastName': 'Adetoro', 'Affiliation': 'Symbiomix Therapeutics, LLC, 1101 E 33rd St, Suite E306, Baltimore, MD, 21218, USA.'}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Tipping', 'Affiliation': 'Prosoft Clinical, Wayne, PA, USA.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Levy', 'Affiliation': 'Prosoft Clinical, Wayne, PA, USA.'}]","Reproductive sciences (Thousand Oaks, Calif.)",['10.1007/s43032-019-00048-x'] 540,30433893,Safety and Tolerability of Vacuum Versus Manual Drainage During Thoracentesis: A Randomized Trial.,"BACKGROUND Pleural effusions may be aspirated manually or via vacuum during thoracentesis. This study compares the safety, pain level, and time involved in these techniques. METHODS We randomized 100 patients receiving ultrasound-guided unilateral thoracentesis in an academic medical center from December 2015 through September 2017 to either vacuum or manual drainage. Without using pleural manometry, the effusion was drained completely or until the development of refractory symptoms. Measurements included self-reported pain before and during the procedure (from 0 to 10), time for completion of drainage, and volume removed. Primary outcomes were rates of all-cause complications and of early termination of the procedure with secondary outcomes of change in pain score, drainage time, volume removed, and inverse rate of removal. RESULTS Patient characteristics in the manual (n=49) and vacuum (n=51) groups were similar. Rate of all-cause complications was higher in the vacuum group (5 vs. 0; P=0.03): pneumothorax (n=3), surgically treated hemothorax with subsequent death (n=1) and reexpansion pulmonary edema causing respiratory failure (n=1), as was rate of early termination (8 vs. 1; P=0.018). The vacuum group exhibited greater pain during drainage (P<0.05), shorter drainage time (P<0.01), no association with volume removed (P>0.05), and lower inverse rate of removal (P≤0.01). CONCLUSION Despite requiring less time, vacuum aspiration during thoracentesis was associated with higher rates of complication and of early termination of the procedure and greater pain. Although larger studies are needed, this pilot study suggests that manual aspiration provides greater safety and patient comfort.",2019,"The vacuum group exhibited greater pain during drainage (P<0.05), shorter drainage time (P<0.01), no association with volume removed (P>0.05), and lower inverse rate of removal (P≤0.01). ","['Patient characteristics in the manual (n=49) and vacuum (n=51) groups were similar', '100 patients receiving ultrasound-guided unilateral thoracentesis in an academic medical center from December 2015 through September 2017 to either']","['vacuum or manual drainage', 'Vacuum Versus Manual Drainage']","['self-reported pain', 'Safety and Tolerability', 'rates of all-cause complications and of early termination of the procedure with secondary outcomes of change in pain score, drainage time, volume removed, and inverse rate of removal', 'time for completion of drainage, and volume removed', 'pain during drainage', 'shorter drainage time', 'Rate of all-cause complications', 'rates of complication and of early termination of the procedure and greater pain', 'rate of early termination', 'safety, pain level']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0175674', 'cui_str': 'Manual (qualifier value)'}, {'cui': 'C0042221', 'cui_str': 'Vacuum'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C0189477', 'cui_str': 'Thoracocentesis'}, {'cui': 'C0000872', 'cui_str': 'University Medical Centers'}]","[{'cui': 'C0042221', 'cui_str': 'Vacuum'}, {'cui': 'C0175674', 'cui_str': 'Manual (qualifier value)'}, {'cui': 'C0013103', 'cui_str': 'Drainage'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0013103', 'cui_str': 'Drainage'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C1883720', 'cui_str': 'Removes'}, {'cui': 'C0439850', 'cui_str': 'Inverse (qualifier value)'}, {'cui': 'C0015252', 'cui_str': 'Removal - action (qualifier value)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}]",100.0,0.381985,"The vacuum group exhibited greater pain during drainage (P<0.05), shorter drainage time (P<0.01), no association with volume removed (P>0.05), and lower inverse rate of removal (P≤0.01). ","[{'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Senitko', 'Affiliation': 'Division of Pulmonary, Critical Care and Sleep Medicine, University of Mississippi Medical Center School of Medicine, Jackson, MS.'}, {'ForeName': 'Amrik S', 'Initials': 'AS', 'LastName': 'Ray', 'Affiliation': 'Division of Pulmonary, Critical Care and Sleep Medicine, Yale University School of Medicine.'}, {'ForeName': 'Terrence E', 'Initials': 'TE', 'LastName': 'Murphy', 'Affiliation': 'Claude D. Pepper Older Americans Independence Center at Yale, Program on Aging, Yale School of Medicine, New Haven, CT.'}, {'ForeName': 'Katy L B', 'Initials': 'KLB', 'LastName': 'Araujo', 'Affiliation': 'Claude D. Pepper Older Americans Independence Center at Yale, Program on Aging, Yale School of Medicine, New Haven, CT.'}, {'ForeName': 'Kyle', 'Initials': 'K', 'LastName': 'Bramley', 'Affiliation': 'Division of Pulmonary, Critical Care and Sleep Medicine, Yale University School of Medicine.'}, {'ForeName': 'Erin M', 'Initials': 'EM', 'LastName': 'DeBiasi', 'Affiliation': 'Division of Pulmonary, Critical Care and Sleep Medicine, Yale University School of Medicine.'}, {'ForeName': 'Margaret A', 'Initials': 'MA', 'LastName': 'Pisani', 'Affiliation': 'Division of Pulmonary, Critical Care and Sleep Medicine, Yale University School of Medicine.'}, {'ForeName': 'Kelsey', 'Initials': 'K', 'LastName': 'Cameron', 'Affiliation': 'Division of Pulmonary, Critical Care and Sleep Medicine, Yale University School of Medicine.'}, {'ForeName': 'Jonathan T', 'Initials': 'JT', 'LastName': 'Puchalski', 'Affiliation': 'Division of Pulmonary, Critical Care and Sleep Medicine, Yale University School of Medicine.'}]",Journal of bronchology & interventional pulmonology,['10.1097/LBR.0000000000000556'] 541,31553945,Parent Perceptions on a Walking School Bus Program Among Low-Income Families: A Qualitative Study.,"BACKGROUND The walking school bus (WSB) is a promising intervention to increase walking to school and physical activity in school-age children. The aim of this qualitative study was to assess parent perceptions of a WSB program that was part of a randomized controlled trial to inform future programs. METHODS The authors interviewed 45 parents whose children had participated in a WSB program in the Seattle area, in which third- and fifth-grade students walked to/from school with adult chaperones along a set route. The authors performed a qualitative analysis of the interview transcripts and coded interview segments into 4 broad categories as follows: facilitators, barriers, general positive sentiments, and proposals. RESULTS Most parents spoke of the benefits of the WSB program; in particular, parents frequently applauded exercise/physical health benefits. Of the barriers, the most frequently cited was time, with work schedule and commute changes leading some families to walk less frequently. CONCLUSIONS Most parents voiced support for the WSB program as a means to improve child health, to learn pedestrian safety, and to interact with positive adult role models. Parents made several suggestions to improve the program, including better recruitment methods, logistical improvements, and a platform for communicating with other parents.",2019,"CONCLUSIONS Most parents voiced support for the WSB program as a means to improve child health, to learn pedestrian safety, and to interact with positive adult role models.","['school-age children', '45 parents whose children had participated in a WSB program in the Seattle area, in which third- and fifth-grade students walked to/from school with adult chaperones along a set route', 'Low-Income Families']",['walking school bus (WSB'],[],"[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0205439', 'cui_str': 'Fifth (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0302604', 'cui_str': 'Low income'}, {'cui': 'C0015576', 'cui_str': 'Family'}]","[{'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0336816', 'cui_str': 'School bus, device (physical object)'}]",[],45.0,0.0365653,"CONCLUSIONS Most parents voiced support for the WSB program as a means to improve child health, to learn pedestrian safety, and to interact with positive adult role models.","[{'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Teller', 'Affiliation': ''}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Abbey-Lambertz', 'Affiliation': ''}, {'ForeName': 'Nasira', 'Initials': 'N', 'LastName': 'Sharma', 'Affiliation': ''}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Waite', 'Affiliation': ''}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Ickes', 'Affiliation': ''}, {'ForeName': 'Jason A', 'Initials': 'JA', 'LastName': 'Mendoza', 'Affiliation': ''}]",Journal of physical activity & health,['10.1123/jpah.2018-0637'] 542,32206987,"Effects of Xuezhitong in Patients with Hypertriglyceridemia: a Multicentre, Randomized, Double-Blind, Double Simulation, Positive Drug and Placebo Parallel Control Study.","BACKGROUD Xuezhitong (XZT) is an extract of Allium macrostemon Bunge that has lipid-lowering properties. OBJECTIVE To evaluate the effects of XZT on lipids in subjects with hypertriglyceridemia (HTG) without severe dyslipidaemia. METHODS A total of 358 subjects with HTG were enrolled and randomly assigned to receive XZT (2700 mg daily), xuezhikang (XZK) (1200 mg daily) or placebo. The primary endpoint was the reduction or percent reduction in the TG level over 12 weeks of treatment. RESULTS At the 12-week follow-up, a reduction in the TG level from baseline was observed in both groups, but the XZT and XZK groups demonstrated a significantly greater reduction than the placebo group (30.77%, 24.02% vs 11.59%, P < 0.0167); 70.54% of subjects in the XZT group and 62.30% of subjects in the XZK group demonstrated reductions in TG levels of at least 20%, compared with 41.67% of the subjects in the placebo group (P < 0.0167). Treatment with XZT capsules also demonstrated superior performance compared with the placebo with respect to the control of lipids (17.97% vs 5.00%), total cholesterol (TC) (14.18% vs 3.89%), low-density lipoprotein cholesterol (LDL-C) (17.98% vs 2.95%), and high-density lipoprotein cholesterol (HDL-C) (21.47% vs 2.16%). Daily use of XZT for 12 weeks resulted in statistically significant (65.22% vs 38.30%, 25.00%; P < 0.0167) and clinically meaningful increases in HDL-C levels by ≥4 mg/dl compared with XZK and placebo. XZT was safe and well tolerated; the safety and tolerability profiles were similar across treatment groups. No subject experienced myopathy or markedly elevated liver transaminases or creatine kinase. CONCLUSIONS XZT significantly reduced TG levels and was well tolerated. Longer-term studies in more diverse patient populations are needed to corroborate these findings. CLINICAL TRIAL REGISTRATION www.chictr.org.cn Identifier: ChiCTR1900025854.",2020,"At the 12-week follow-up, a reduction in the TG level from baseline was observed in both groups, but the XZT and XZK groups demonstrated a significantly greater reduction than the placebo group (30.77%, 24.02% vs 11.59%, P < 0.0167); 70.54% of subjects in the XZT group and 62.30% of subjects in the XZK group demonstrated reductions in TG levels of at least 20%, compared with 41.67% of the subjects in the placebo group (P < 0.0167).","['subjects with hypertriglyceridemia (HTG) without severe dyslipidaemia', '358 subjects with HTG', 'Patients with Hypertriglyceridemia']","['Xuezhitong (XZT', 'placebo', 'XZK', 'Xuezhitong', 'XZT', 'xuezhikang (XZK', 'XZK and placebo']","['reduction or percent reduction in the TG level', 'tolerated', 'high-density lipoprotein cholesterol (HDL-C', 'safe and well tolerated; the safety and tolerability profiles', 'total cholesterol (TC', 'HDL-C levels', 'TG levels', 'TG level', 'superior performance', 'low-density lipoprotein cholesterol (LDL-C']","[{'cui': 'C0020557', 'cui_str': 'Hypertriglyceridemia'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1869029', 'cui_str': 'Dyslipidaemia (SMQ)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1566069', 'cui_str': 'xuezhikang'}]","[{'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0439165', 'cui_str': 'Percent (property) (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0023822', 'cui_str': 'High Density Lipoprotein Cholesterol'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement (procedure)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}]",358.0,0.475119,"At the 12-week follow-up, a reduction in the TG level from baseline was observed in both groups, but the XZT and XZK groups demonstrated a significantly greater reduction than the placebo group (30.77%, 24.02% vs 11.59%, P < 0.0167); 70.54% of subjects in the XZT group and 62.30% of subjects in the XZK group demonstrated reductions in TG levels of at least 20%, compared with 41.67% of the subjects in the placebo group (P < 0.0167).","[{'ForeName': 'Wenhao', 'Initials': 'W', 'LastName': 'Jia', 'Affiliation': 'Beijing University of Chinese Medicine, Beijing, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Dongfang Hospital, Beijing University of Chinese Medicine, Beijing, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Wan', 'Affiliation': 'Dongfang Hospital, Beijing University of Chinese Medicine, Beijing, China.'}, {'ForeName': 'Xiaoyun', 'Initials': 'X', 'LastName': 'Cui', 'Affiliation': 'Dongfang Hospital, Beijing University of Chinese Medicine, Beijing, China.'}, {'ForeName': 'Jinjin', 'Initials': 'J', 'LastName': 'Lu', 'Affiliation': 'Dongfang Hospital, Beijing University of Chinese Medicine, Beijing, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Dongfang Hospital, Beijing University of Chinese Medicine, Beijing, China.'}, {'ForeName': 'Dong', 'Initials': 'D', 'LastName': 'Li', 'Affiliation': 'Dongfang Hospital, Beijing University of Chinese Medicine, Beijing, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Technology Center for Drug Research and Evaluation, Chinese Association of Traditional Chinese Medicine, Beijing, China.'}, {'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Zou', 'Affiliation': 'Beijing Compete Pharmaceutical Technology Development Co. LTD, Beijing, China.'}, {'ForeName': 'Junpin', 'Initials': 'J', 'LastName': 'Ding', 'Affiliation': 'Harbin kansaisi Pharmaceutical Technology Development co. LTD, Harbin, China.'}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Lin', 'Affiliation': 'Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, China. linqian62@126.com.'}]",Cardiovascular drugs and therapy,['10.1007/s10557-020-06965-3'] 543,32403207,The effect of insemination methods on in vitro maturation outcomes.,"OBJECTIVE The aim of this study was to compare the effects of conventional insemination (in vitro fertilization [IVF]) and intracytoplasmic sperm injection (ICSI) on the fertilization, developmental competence, implantation potential, and clinical pregnancy rate of embryos derived from in vitro matured oocytes of patients with polycystic ovary syndrome (PCOS). METHODS A prospective study was carried out among 38 PCOS patients who had undergone in vitro maturation (IVM) treatment. In total, 828 immature oocytes were collected from 42 cycles and randomly assigned for insemination by IVF (416 oocytes) or ICSI (412 oocytes). After fertilization, the embryos were cultured until the blastocyst stage and single embryos were transferred after endometrial preparation and under ultrasound guidance. RESULTS No significant differences were found in the maturation rate (78.1% vs. 72.6% for IVF and ICSI insemination, respectively; p= 0.076), fertilization rate (59.4% vs. 66.9% for IVF and ICSI insemination, respectively; p= 0.063), or the formation of good-quality blastocysts (40.9% vs. 46.5% for IVF and ICSI insemination, respectively; p= 0.314). Implantation and clinical pregnancy also did not show significant differences. CONCLUSION There was a comparable yield of in vitro matured oocytes derived from PCOS patients in terms of fertilization, blastocyst formation, implantation rate, and clinical pregnancy between IVF and ICSI insemination. These findings provide valuable insights for choosing assisted reproductive treatment in women with PCOS, as IVM offers promising outcomes and is less invasive and less costly.",2020,"There was a comparable yield of in vitro matured oocytes derived from PCOS patients in terms of fertilization, blastocyst formation, implantation rate, and clinical pregnancy between IVF and ICSI insemination.","['women with PCOS', '38 PCOS patients who had undergone in vitro maturation (IVM) treatment', '828 immature oocytes were collected from 42 cycles and randomly assigned for insemination by IVF (416 oocytes) or ICSI (412 oocytes', 'patients with polycystic ovary syndrome (PCOS']",['conventional insemination (in vitro fertilization [IVF]) and intracytoplasmic sperm injection (ICSI'],"['fertilization rate', 'maturation rate', 'fertilization, developmental competence, implantation potential, and clinical pregnancy rate of embryos', 'fertilization, blastocyst formation, implantation rate, and clinical pregnancy', 'formation of good-quality blastocysts']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032460', 'cui_str': 'Polycystic ovary syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021135', 'cui_str': 'In Vitro'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205252', 'cui_str': 'Immature'}, {'cui': 'C0029045', 'cui_str': 'Oocyte'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0021586', 'cui_str': 'Insemination'}, {'cui': 'C0015915', 'cui_str': 'In vitro fertilization'}, {'cui': 'C0455164', 'cui_str': 'IVF - In vitro fertilization with intracytoplasmic sperm injection (ICSI)'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0021586', 'cui_str': 'Insemination'}, {'cui': 'C0015915', 'cui_str': 'In vitro fertilization'}, {'cui': 'C0455164', 'cui_str': 'IVF - In vitro fertilization with intracytoplasmic sperm injection (ICSI)'}]","[{'cui': 'C0015914', 'cui_str': 'Fertilization'}, {'cui': 'C0458003', 'cui_str': 'Developmental'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rates'}, {'cui': 'C0013935', 'cui_str': 'Embryos'}, {'cui': 'C1281743', 'cui_str': 'Blastocyst structure'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0332306', 'cui_str': 'Quality'}]",38.0,0.185798,"There was a comparable yield of in vitro matured oocytes derived from PCOS patients in terms of fertilization, blastocyst formation, implantation rate, and clinical pregnancy between IVF and ICSI insemination.","[{'ForeName': 'Pallop', 'Initials': 'P', 'LastName': 'Pongsuthirak', 'Affiliation': 'Department of Obstetrics and Gynecology, Buddhachinaraj Hospital Medical School, Phitsanulok, Thailand.'}]",Clinical and experimental reproductive medicine,['10.5653/cerm.2019.03300'] 544,32404035,Antithrombotic Treatment of Embolic Stroke of Undetermined Source: RE-SPECT ESUS Elderly and Renally Impaired Subgroups.,"Background and Purpose- The RE-SPECT ESUS trial (Randomized, Double-Blind, Evaluation in Secondary Stroke Prevention Comparing the Efficacy and Safety of the Oral Thrombin Inhibitor Dabigatran Etexilate Versus Acetylsalicylic Acid in Patients With Embolic Stroke of Undetermined Source) tested the hypothesis that dabigatran would be superior to aspirin for the prevention of recurrent stroke in patients with embolic stroke of undetermined source. This exploratory subgroup analysis investigates the impact of age, renal function (both predefined), and dabigatran dose (post hoc) on the rates of recurrent stroke and major bleeding. Methods- RE-SPECT ESUS was a multicenter, randomized, double-blind trial of dabigatran 150 or 110 mg (for patients aged ≥75 years and/or with creatinine clearance 30 to <50 mL/minute) twice daily compared with aspirin 100 mg once daily. The primary outcome was recurrent stroke. Results- The trial, which enrolled 5390 patients from December 2014 to January 2018, did not demonstrate superiority of dabigatran versus aspirin for prevention of recurrent stroke in patients with embolic stroke of undetermined source. However, among the population qualifying for the lower dabigatran dose, the rate of recurrent stroke was reduced with dabigatran versus aspirin (7.4% versus 13.0%; hazard ratio, 0.57 [95% CI, 0.39-0.82]; interaction P =0.01). This was driven mainly by the subgroup aged ≥75 years (7.8% versus 12.4%; hazard ratio, 0.63 [95% CI, 0.43-0.94]; interaction P =0.10). Stroke rates tended to be lower with dabigatran versus aspirin with declining renal function. Risks for major bleeding were similar between treatments, irrespective of renal function, but with a trend for lower bleeding rates with dabigatran versus aspirin in older patients. Conclusions- In subgroup analyses of RE-SPECT ESUS, dabigatran reduced the rate of recurrent stroke compared with aspirin in patients qualifying for the lower dose of dabigatran. These results are hypothesis-generating. Aspirin remains the standard antithrombotic treatment for patients with embolic stroke of undetermined source. Registration- URL: https://www.clinicaltrials.gov; Unique identifier: NCT02239120.",2020,"Risks for major bleeding were similar between treatments, irrespective of renal function, but with a trend for lower bleeding rates with dabigatran versus aspirin in older patients.","['patients aged ≥75 years and/or with creatinine clearance 30 to <50 mL/minute) twice daily compared with', 'older patients', 'patients with embolic stroke of undetermined source', 'Patients With Embolic Stroke of Undetermined Source', '5390 patients from December 2014 to January 2018']","['Oral Thrombin Inhibitor Dabigatran Etexilate Versus Acetylsalicylic Acid', 'aspirin 100 mg once daily', 'Methods- RE-SPECT ESUS', 'Aspirin', ' and Purpose', 'dabigatran versus aspirin', 'aspirin', 'Conclusions', 'dabigatran']","['Stroke rates', 'Risks for major bleeding', 'recurrent stroke', 'rates of recurrent stroke and major bleeding', 'rate of recurrent stroke', 'bleeding rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0373595', 'cui_str': 'Measurement of renal clearance of creatinine'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C3888970', 'cui_str': 'Embolic stroke of undetermined source'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0040018', 'cui_str': 'Thrombin'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C1571583', 'cui_str': 'dabigatran etexilate'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C1124475', 'cui_str': 'Aspirin 100 MG'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0040399', 'cui_str': 'Single photon emission computerized tomography'}, {'cui': 'C1285529', 'cui_str': 'Purpose'}, {'cui': 'C2348066', 'cui_str': 'dabigatran'}]","[{'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1836785', 'cui_str': 'Recurrent stroke'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}]",5390.0,0.375563,"Risks for major bleeding were similar between treatments, irrespective of renal function, but with a trend for lower bleeding rates with dabigatran versus aspirin in older patients.","[{'ForeName': 'Hans-Christoph', 'Initials': 'HC', 'LastName': 'Diener', 'Affiliation': 'From the Faculty of Medicine, Institute for Medical Informatics, Biometry and Epidemiology, University Duisburg-Essen, Germany (H.-C.D.).'}, {'ForeName': 'Ralph L', 'Initials': 'RL', 'LastName': 'Sacco', 'Affiliation': 'Clinical and Translational Science, Miller School of Medicine, University of Miami, FL (R.L.S.).'}, {'ForeName': 'J Donald', 'Initials': 'JD', 'LastName': 'Easton', 'Affiliation': 'Department of Neurology, University of California, San Francisco (J.D.E.).'}, {'ForeName': 'Christopher B', 'Initials': 'CB', 'LastName': 'Granger', 'Affiliation': 'Duke Clinical Research Institute, Duke University Medical Center, Durham, NC (C.B.G.).'}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Bar', 'Affiliation': 'Department of Neurology, University Hospital Ostrava, Ostrava-Poruba-Poruba, Czech Republic (M. Bar).'}, {'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Bernstein', 'Affiliation': 'Department of Neurology, Northwestern University, Chicago, IL (R.A.B.).'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Brainin', 'Affiliation': 'Department of Neurosciences and Preventive Medicine, Danube University Krems, Krems an der Donau, Austria (M. Brainin).'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Brueckmann', 'Affiliation': 'Metabolism Medicine, Boehringer Ingelheim International GmbH, Germany (M. Brueckmann).'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Cronin', 'Affiliation': 'Cardiometabolic Medicine, Boehringer Ingelheim Ltd, Burlington, ON, Canada (L.C.).'}, {'ForeName': 'Geoffrey', 'Initials': 'G', 'LastName': 'Donnan', 'Affiliation': 'Department of Neurology, Melbourne Brain Centre, University of Melbourne, Parkville, VIC, Australia (G.D.).'}, {'ForeName': 'Zuzana', 'Initials': 'Z', 'LastName': 'Gdovinová', 'Affiliation': 'Department of Neurology, Pavol Jozef Šafárik University in Košice, University Hospital L. Pasteur, Košice, Slovak Republic (Z.G.).'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Grauer', 'Affiliation': 'Clinical Operations Global, Boehringer Ingelheim Pharma GmbH & Co. K.G., Biberach, Germany (C.G.).'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Kleine', 'Affiliation': 'Biostatistics and Data Sciences, Boehringer Ingelheim Pharma GmbH & Co. K.G., Ingelheim, Germany (E.K.).'}, {'ForeName': 'Timothy J', 'Initials': 'TJ', 'LastName': 'Kleinig', 'Affiliation': 'Department of Neurology, Royal Adelaide Hospital, Adelaide, South Australia, Australia (T.J.K.).'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Lyrer', 'Affiliation': 'Division of Neurology, Stroke Center, University Hospital Basel, Switzerland (P.L.).'}, {'ForeName': 'Sheila', 'Initials': 'S', 'LastName': 'Martins', 'Affiliation': 'Neurology Service, Hospital de Clínicas de Porto Alegre, Brazil (S.M.).'}, {'ForeName': 'Juliane', 'Initials': 'J', 'LastName': 'Meyerhoff', 'Affiliation': 'Cardiology Medicine, Boehringer Ingelheim International GmbH, Germany (J.M.).'}, {'ForeName': 'Truman', 'Initials': 'T', 'LastName': 'Milling', 'Affiliation': 'Department of Neurology, Department of Surgery and Perioperative Care, Seton Dell Medical School Stroke Institute, Austin, TX (T.M.).'}, {'ForeName': 'Waltraud', 'Initials': 'W', 'LastName': 'Pfeilschifter', 'Affiliation': 'Center of Neurology and Neurosurgery, Goethe University Frankfurt, Frankfurt am Main, Germany (W.P.).'}, {'ForeName': 'Sven', 'Initials': 'S', 'LastName': 'Poli', 'Affiliation': 'Department of Neurology with Focus on Neurovascular Diseases and Neurooncology, University of Tübingen, and Hertie Institute for Clinical Brain Research, Germany (S.P.).'}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Reif', 'Affiliation': 'Department of Neurology, Cerebrovaskulární ambulance s.r.o., Brno, Czech Republic (M.R.).'}, {'ForeName': 'David Z', 'Initials': 'DZ', 'LastName': 'Rose', 'Affiliation': 'Department of Neurology, Morsani College of Medicine, University of South Florida, Tampa (D.Z.R.).'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Šaňák', 'Affiliation': 'Comprehensive Stroke Center, Department of Neurology, Palacky University, Olomouc, Czech Republic (D.S.).'}, {'ForeName': 'Wolf-Rüdiger', 'Initials': 'WR', 'LastName': 'Schäbitz', 'Affiliation': 'Department of Neurology, Evangelisches Klinikum Bethel, Bielefeld, Germany (W.-R.S.).'}]",Stroke,['10.1161/STROKEAHA.119.028643'] 545,32406100,Comparison between minimal fluoroscopy and conventional approaches for visually guided laser balloon pulmonary vein isolation ablation.,"INTRODUCTION Although balloon-based techniques, such as the laser balloon (LB) ablation have simplified pulmonary vein isolation (PVI), procedural fluoroscopy usage remains higher in comparison to radiofrequency PVI approaches due to limited 3-dimensional mapping system integration. METHODS In this prospective study, 50 consecutive patients were randomly assigned in alternating fashion to a low fluoroscopy group (LFG; n = 25) or conventional fluoroscopy group (CFG; n = 25) and underwent de novo PVI procedures using visually guided LB technique. RESULTS There was no statistical difference in baseline characteristics or cross-overs between treatment groups. Acute PVI was accomplished in all patients. Mean follow up was 318 ± 69 days. Clinical recurrence of atrial fibrillation after PVI was similar between groups (CFG: 19% vs LFG: 15%; P = .72). Total fluoroscopy time was significantly lower in the LFG than the CFG (1.7 ± 1.4  vs 16.9 ± 5.9 minutes; P < .001) despite similar total procedure duration (143 ± 22 vs 148 ± 22 minutes; P = .42) and mean LA dwell time (63 ± 15 vs 59 ± 10 minutes; P = .28). Mean dose area product was significantly lower in the LFG (181 ± 125 vs 1980 ± 750 μGym 2 ; P < .001). Fluoroscopy usage after transseptal access was substantially lower in the LFG (0.63 ± 0.43 vs 11.70 ± 4.32 minutes; P < .001). Complications rates were similar between both groups (4% vs 2%; P = .57). CONCLUSIONS This study demonstrates that LB PVI can be safely achieved using a novel low fluoroscopy protocol while also substantially reducing fluoroscopy usage and radiation exposure in comparison to conventional approaches for LB ablation.",2020,Clinical recurrence of AF after PVI was similar between groups (CFG: 19% vs LFG: 15%; p=0.72).,['50 consecutive patients'],"['Minimal Fluoroscopy and Conventional Approaches for Visually Guided Laser Balloon Pulmonary Vein Isolation Ablation', 'LB PVI', 'LFG', 'laser balloon (LB) ablation', 'low fluoroscopy group (LFG, n=25) or conventional fluoroscopy group (CFG, n=25) and underwent de novo PVI procedures using visually guided LB technique']","['Acute PVI', 'Mean DAP', 'Fluoroscopy usage after transseptal access', 'Clinical recurrence of AF after PVI', 'mean LA dwell time', 'Total fluoroscopy time', 'Complications rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0016356', 'cui_str': 'Fluoroscopy'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft'}, {'cui': 'C3544330', 'cui_str': 'Pulmonary vein isolation'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C3544330', 'cui_str': 'Pulmonary vein isolation'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0045587', 'cui_str': '2,6-diaminopurine'}, {'cui': 'C0016356', 'cui_str': 'Fluoroscopy'}, {'cui': 'C0457083', 'cui_str': 'Usage'}, {'cui': 'C0442381', 'cui_str': 'Transseptal nasal approach'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0429659', 'cui_str': 'Dwell time'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",50.0,0.0493569,Clinical recurrence of AF after PVI was similar between groups (CFG: 19% vs LFG: 15%; p=0.72).,"[{'ForeName': 'Henry D', 'Initials': 'HD', 'LastName': 'Huang', 'Affiliation': 'Division of Cardiology, Rush University Medical Center, Chicago, Illinois.'}, {'ForeName': 'Jason M', 'Initials': 'JM', 'LastName': 'Rodriguez', 'Affiliation': 'Division of Cardiology, Rush University Medical Center, Chicago, Illinois.'}, {'ForeName': 'Nicholas J', 'Initials': 'NJ', 'LastName': 'Serafini', 'Affiliation': 'Division of Cardiology, Rush University Medical Center, Chicago, Illinois.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Macias', 'Affiliation': 'Division of Cardiology, UCLA Cardiac Arrhythmia Center, Ronald Reagan UCLA Medical Center, Los Angeles, California.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Winterfield', 'Affiliation': 'Division of Cardiology, Medical University of South Carolina, Charleston, South Carolina.'}, {'ForeName': 'Parikshit S', 'Initials': 'PS', 'LastName': 'Sharma', 'Affiliation': 'Division of Cardiology, Rush University Medical Center, Chicago, Illinois.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Larsen', 'Affiliation': 'Division of Cardiology, Rush University Medical Center, Chicago, Illinois.'}, {'ForeName': 'Kousik', 'Initials': 'K', 'LastName': 'Krishnan', 'Affiliation': 'Division of Cardiology, Rush University Medical Center, Chicago, Illinois.'}, {'ForeName': 'Richard G', 'Initials': 'RG', 'LastName': 'Trohman', 'Affiliation': 'Division of Cardiology, Rush University Medical Center, Chicago, Illinois.'}]",Journal of cardiovascular electrophysiology,['10.1111/jce.14546'] 546,30060681,Nonsurgical Treatment of De Quervain Tenosynovitis: A Prospective Randomized Trial.,"Background: De Quervain tenosynovitis is commonly seen in patients who perform repetitive wrist ulnar deviation with thumb abduction and extension. Previous studies comparing nonsurgical options have contributed to a lack of consensus about ideal management. This study's purpose was to analyze results in prospectively randomized patients treated with either corticosteroid injection (CSI) alone versus CSI with immobilization. Methods: Radial sided wrist pain, first dorsal compartment tenderness, and positive Finkelstein test were used to define De Quervain. Pain score of 4 or higher on a visual analog scale (VAS) was utilized for inclusion. Following exclusion criteria, patients underwent randomization into groups: (1) CSI alone; or (2) CSI with 3 weeks of immobilization. We followed at 3 weeks and 6 months for further evaluation, where resolution of symptoms and improvements in VAS and Disabilities of the Arm, Shoulder, and Hand (DASH) scores were assessed to evaluate treatment success. Results: Nine patients with CSI alone and 11 patients with CSI and immobilization were followed. At 6 months in both groups, patients experienced significant improvement in VAS and DASH scores, while 88% of patients with CSI alone and 73% of patients with CSI and immobilization experienced complete resolution of at least 2 out of 3 of their pretreatment symptoms. Between groups, outcomes were comparable except for resolution of radial-sided wrist pain, which was superior in patients with CSI alone (100% vs 64%). Conclusions: Immobilization following injection increases costs, may hinder activities of daily living, and did not contribute to improved patient outcomes in this study. Further prospective studies are warranted.",2020,"Between groups, outcomes were comparable except for resolution of radial-sided wrist pain, which was superior in patients with CSI alone (100% vs 64%). ","['patients who perform repetitive wrist ulnar deviation with thumb abduction and extension', 'De Quervain Tenosynovitis', 'Nine patients with CSI alone and 11 patients with CSI and immobilization']",['corticosteroid injection (CSI) alone versus CSI with immobilization'],"['VAS and DASH scores', 'resolution of symptoms and improvements in VAS and Disabilities of the Arm, Shoulder, and Hand (DASH) scores', 'resolution of radial-sided wrist pain', 'visual analog scale (VAS', 'Pain score']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0043262', 'cui_str': 'Wrist'}, {'cui': 'C0449752', 'cui_str': 'Ulnar deviation (qualifier value)'}, {'cui': 'C0040067', 'cui_str': 'Thumb'}, {'cui': 'C0231456', 'cui_str': 'Abduction, function (observable entity)'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C0149870', 'cui_str': 'Stenosing Tenosynovitis, De Quervain'}, {'cui': 'C0020944', 'cui_str': 'Immobilization'}]","[{'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0020944', 'cui_str': 'Immobilization'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0037004', 'cui_str': 'Shoulder'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0442038', 'cui_str': 'Radial (qualifier value)'}, {'cui': 'C0221785', 'cui_str': 'Wrist joint pain (finding)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}]",9.0,0.0772992,"Between groups, outcomes were comparable except for resolution of radial-sided wrist pain, which was superior in patients with CSI alone (100% vs 64%). ","[{'ForeName': 'Joseph A', 'Initials': 'JA', 'LastName': 'Ippolito', 'Affiliation': 'Rutgers New Jersey Medical School, Newark, USA.'}, {'ForeName': 'Spencer', 'Initials': 'S', 'LastName': 'Hauser', 'Affiliation': 'Rutgers New Jersey Medical School, Newark, USA.'}, {'ForeName': 'Jay', 'Initials': 'J', 'LastName': 'Patel', 'Affiliation': 'Rutgers New Jersey Medical School, Newark, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Vosbikian', 'Affiliation': 'Rutgers New Jersey Medical School, Newark, USA.'}, {'ForeName': 'Irfan', 'Initials': 'I', 'LastName': 'Ahmed', 'Affiliation': 'Rutgers New Jersey Medical School, Newark, USA.'}]","Hand (New York, N.Y.)",['10.1177/1558944718791187'] 547,32207636,Resource utilization associated with hospital and office-based insertion of a miniaturized insertable cardiac monitor: results from the RIO 2 randomized US study.,"Background: Previous studies support operational benefits when moving insertable cardiac monitor (ICM) insertions outside the cardiac catheterization/electrophysiology laboratories, but this has not been directly assessed in a randomized trial or when the procedure is specifically moved to the office setting. To gain insight, the RIO 2 US study collected resource utilization and procedure time intervals for ICM insertion in-office and in-hospital and these data were used to calculate costs associated with staff time and supply use in each setting. Methods and results: The Reveal LINQ In-Office 2 US study (randomized [1:1], multicenter, unblinded) included 482 patients to undergo insertion of the ICM in-hospital (in an operating room or CATH/EP laboratory) ( n  = 251) or in-office ( n  = 231). Detailed information on resource utilization was collected prospectively by the study and used to compare resource utilization and procedure time intervals during ICM insertion procedures performed in-office vs. in-hospital. In addition, costs associated with staff time and supply use in each setting were calculated retrospectively. Total visit duration (check-in to discharge) was 107 min shorter in-office vs. in-hospital (95% CI = 97-116 min; p  < 0.001). Patient preparation and education in-office were more likely to occur in the same room as the procedure, compared with in-hospital (91.6% vs. 34.2%, p  < 0.001 and 87.3% vs. 22.1%, p  < 0.001, respectively). There was a reduction in registered nurse and cardiovascular/operating room technologist involvement in-office, accompanied by higher physician and medical assistant participation. Overall staff time spent per case was 75% higher in-hospital, leading to 50% higher staffing costs compared to in-office. Conclusions: ICM insertion in a physician's office vs. a hospital setting resulted in reduced patient visit time and reduced overall staff time, with a consequent reduction in staffing costs. Clinical trial registration: ClinicalTrials.gov NCT02395536.",2020,"Overall staff time spent per case was 75% higher in-hospital, leading to 50% higher staffing costs compared to in-office.","['482 patients to undergo insertion of the ICM in-hospital (in an operating room, or CATH/EP laboratory) (n\u2009=\u2009251) or in-office (n\u2009=\u2009231']",['LINQ'],"['Total visit duration (check-in to discharge', 'Overall staff time spent per case', 'patient visit time and reduced overall staff time']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0029064', 'cui_str': 'Operating Room'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0761050', 'cui_str': '(GVGVP)251'}, {'cui': 'C0442603', 'cui_str': 'Office (environment)'}]",[],"[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C2700616', 'cui_str': 'Manpowers'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}]",482.0,0.0912432,"Overall staff time spent per case was 75% higher in-hospital, leading to 50% higher staffing costs compared to in-office.","[{'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Rogers', 'Affiliation': 'Department of Cardiology, Scripps Green Hospital, La Jolla, CA, USA.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Piorkowski', 'Affiliation': 'Department of Electrophysiology, Herzzentrum Dresden, Dresden, Germany.'}, {'ForeName': 'M Rizwan', 'Initials': 'MR', 'LastName': 'Sohail', 'Affiliation': 'Divisions of Infectious Diseases and Cardiovascular Diseases, Mayo Clinic College of Medicine, Rochester, MN, USA.'}, {'ForeName': 'Rishi', 'Initials': 'R', 'LastName': 'Anand', 'Affiliation': 'Electrophysiology Laboratory, Holy Cross Hospital, Fort Lauderdale, FL, USA.'}, {'ForeName': 'Marcin', 'Initials': 'M', 'LastName': 'Kowalski', 'Affiliation': 'Division of Electrophysiology, Department of Cardiology, Staten Island University Hospital and Northwell Health System, Manhasset, NY, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Rosemas', 'Affiliation': 'Cardiac Rhythm and Heart Failure, Medtronic, Inc, Mounds View, MN, USA.'}, {'ForeName': 'Kurt', 'Initials': 'K', 'LastName': 'Stromberg', 'Affiliation': 'Cardiac Rhythm and Heart Failure, Medtronic, Inc, Mounds View, MN, USA.'}, {'ForeName': 'Prashanthan', 'Initials': 'P', 'LastName': 'Sanders', 'Affiliation': 'Department of Cardiology, Royal Adelaide Hospital, Centre for Heart Rhythm Disorders, University of Adelaide, Adelaide, Australia.'}]",Journal of medical economics,['10.1080/13696998.2020.1746548'] 548,32402931,Long-term outcome of perioperative low cardiac output syndrome in cardiac surgery: 1-year results of a multicenter randomized trial.,"PURPOSE Perioperative myocardial dysfunction occurs frequently in cardiac surgery, and is a risk factor for morbidity and mortality. Levosimendan has been suggested to reduce mortality of patients with perioperative myocardial dysfunction. However, long-term outcome data on its efficacy in cardiac surgery are lacking. MATERIALS AND METHODS Cardiac surgery patients with perioperative myocardial dysfunction were randomized to levosimendan or placebo, in addition to standard inotropic care. One-year mortality data were collected. RESULTS We randomized 506 patients (248 to levosimendan 258 to placebo). At 1-year follow-up, 41 patients (16.5%) died in the levosimendan group, while 47 (18.3%) died in the placebo group (absolute risk difference -1.8; 95% CI -8.4 to 4.9; P = .60). Female sex, history of chronic obstructive pulmonary disease, previous myocardial infarction, serum creatinine, hematocrit, mean arterial pressure, and duration of cardiopulmonary bypass were independently associated with 1-year mortality. CONCLUSIONS Levosimendan administration does not improve 1-year survival in cardiac surgery patients with perioperative myocardial dysfunction. One-year mortality in these patients is 17%. Six predictive factors for long-term mortality were identified. STUDY REGISTRATION NUMBER NCT00994825 (ClinicalTrials.gov).",2020,"At 1-year follow-up, 41 patients (16.5%) died in the levosimendan group, while 47 (18.3%) died in the placebo group (absolute risk difference -1.8; 95% CI -8.4 to 4.9; P = .60).","['Cardiac surgery patients with perioperative myocardial dysfunction', 'cardiac surgery', 'cardiac surgery patients with perioperative myocardial dysfunction', '506 patients (248 to', 'patients with perioperative myocardial dysfunction']","['Levosimendan', 'perioperative low cardiac output syndrome', 'levosimendan', 'levosimendan 258 to placebo', 'levosimendan or placebo']","['Female sex, history of chronic obstructive pulmonary disease, previous myocardial infarction, serum creatinine, hematocrit, mean arterial pressure, and duration of cardiopulmonary bypass', '1-year survival']","[{'cui': 'C0018821', 'cui_str': 'Operation on heart'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0340515', 'cui_str': 'Myocardial dysfunction'}]","[{'cui': 'C0246904', 'cui_str': 'Levosimendan'}, {'cui': 'C0600177', 'cui_str': 'Low cardiac output syndrome'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0086287', 'cui_str': 'Female'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0155668', 'cui_str': 'Old myocardial infarction'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum'}, {'cui': 'C0018935', 'cui_str': 'Hematocrit determination'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0007202', 'cui_str': 'Cardiopulmonary bypass operation'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",506.0,0.403453,"At 1-year follow-up, 41 patients (16.5%) died in the levosimendan group, while 47 (18.3%) died in the placebo group (absolute risk difference -1.8; 95% CI -8.4 to 4.9; P = .60).","[{'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Zangrillo', 'Affiliation': 'Department of Anesthesia and Intensive Care, IRCCS San Raffaele Scientific Institute, Milan, Italy; Vita-Salute San Raffaele University, Milan, Italy.'}, {'ForeName': 'Vladimir V', 'Initials': 'VV', 'LastName': 'Lomivorotov', 'Affiliation': 'Department of Anesthesiology and Intensive Care, E. Meshalkin National Medical Research Center, Novosibirsk, Russia; Novosibirsk State University, Novosibirsk, Russia.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Pisano', 'Affiliation': 'Division of Cardiac Anesthesia and Intensive Care Unit, AORN dei Colli - Monaldi Hospital, Naples, Italy.'}, {'ForeName': 'Maria Grazia', 'Initials': 'MG', 'LastName': 'Calabrò', 'Affiliation': 'Department of Anesthesia and Intensive Care, IRCCS San Raffaele Scientific Institute, Milan, Italy.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Belletti', 'Affiliation': 'Department of Anesthesia and Intensive Care, IRCCS San Raffaele Scientific Institute, Milan, Italy.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Brazzi', 'Affiliation': 'Department of Anesthesia, Intensive Care and Emergency, Città della Salute e della Scienza Hospital, Turin, Italy; Department of Surgical Sciences, University of Turin, Turin, Italy.'}, {'ForeName': 'Evgeny V', 'Initials': 'EV', 'LastName': 'Grigoryev', 'Affiliation': 'Intensive Care Unit, Scientific Research Institute for Complex Issues of Cardiovascular Diseases, Kemerovo, Russia.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Guarracino', 'Affiliation': 'Division of Cardiothoracic Anesthesia and Intensive Care, Department of Anesthesia and Critical Care Medicine, AOU Pisana, Pisa, Italy.'}, {'ForeName': 'Fabrizio', 'Initials': 'F', 'LastName': 'Monaco', 'Affiliation': 'Department of Anesthesia and Intensive Care, IRCCS San Raffaele Scientific Institute, Milan, Italy.'}, {'ForeName': 'Eugenio', 'Initials': 'E', 'LastName': 'Garofalo', 'Affiliation': 'Department of Anesthesia and Intensive Care, AOU Mater Domini Germaneto, Catanzaro, Italy.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Crivellari', 'Affiliation': 'Department of Anesthesia and Intensive Care, IRCCS San Raffaele Scientific Institute, Milan, Italy.'}, {'ForeName': 'Valery V', 'Initials': 'VV', 'LastName': 'Likhvantsev', 'Affiliation': 'Department of Anesthesiology and Intensive Care, First Moscow State Medical University, Moscow, Russia; V. Negovsky Reanimatology Research Institute, Moscow, Russia.'}, {'ForeName': 'Evgeny V', 'Initials': 'EV', 'LastName': 'Fominskiy', 'Affiliation': 'Department of Anesthesia and Intensive Care, IRCCS San Raffaele Scientific Institute, Milan, Italy.'}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Paternoster', 'Affiliation': 'Department of Anesthesia and Intensive Care, San Carlo Hospital, Potenza, Italy.'}, {'ForeName': 'Andrey', 'Initials': 'A', 'LastName': 'Yavorovskiy', 'Affiliation': 'Department of Anesthesiology and Intensive Care, First Moscow State Medical University, Moscow, Russia.'}, {'ForeName': 'Vadim V', 'Initials': 'VV', 'LastName': 'Pasyuga', 'Affiliation': 'Department of Anesthesiology and Intensive Care, Federal Center for Cardiovascular Surgery Astrakhan, Astrakhan, Russia.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Oriani', 'Affiliation': 'Department of Anesthesia and Intensive Care, IRCCS San Raffaele Scientific Institute, Milan, Italy.'}, {'ForeName': 'Rosalba', 'Initials': 'R', 'LastName': 'Lembo', 'Affiliation': 'Department of Anesthesia and Intensive Care, IRCCS San Raffaele Scientific Institute, Milan, Italy.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Bianchi', 'Affiliation': 'Department of Cardiovascular Anesthesia and Intensive Care, AO Ordine Mauriziano, Turin, Italy.'}, {'ForeName': 'A Mara', 'Initials': 'AM', 'LastName': 'Scandroglio', 'Affiliation': 'Department of Anesthesia and Intensive Care, IRCCS San Raffaele Scientific Institute, Milan, Italy.'}, {'ForeName': 'Marat N', 'Initials': 'MN', 'LastName': 'Abubakirov', 'Affiliation': 'Department of Anesthesiology and Intensive Care, E. Meshalkin National Medical Research Center, Novosibirsk, Russia.'}, {'ForeName': 'Nora', 'Initials': 'N', 'LastName': 'Di Tomasso', 'Affiliation': 'Department of Anesthesia and Intensive Care, IRCCS San Raffaele Scientific Institute, Milan, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Landoni', 'Affiliation': 'Department of Anesthesia and Intensive Care, IRCCS San Raffaele Scientific Institute, Milan, Italy; Vita-Salute San Raffaele University, Milan, Italy. Electronic address: landoni.giovanni@hsr.it.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of critical care,['10.1016/j.jcrc.2020.04.005'] 549,32403938,Effectiveness of embedding a specialist preventive care clinician in a community mental health service in increasing preventive care provision: A randomised controlled trial.,"OBJECTIVE Clinical practice guidelines recommend that community mental health services provide preventive care for clients' chronic disease risk behaviours; however, such care is often not routinely provided. This study aimed to assess the effectiveness of offering clients an additional consultation with a specialist clinician embedded within a community mental health service, in increasing client-reported receipt of, and satisfaction with, preventive care. METHOD A randomised controlled trial was undertaken in one Australian community mental health service. Participants ( N  = 811) were randomised to receive usual care (preventive care in routine consultations; n  = 405) or usual care plus the offer of an additional consultation with a specialist preventive care clinician ( n  = 406). Blinded interviewers assessed at baseline and 1-month follow-up the client-reported receipt of preventive care (assessment, advice and referral) for four key risk behaviours individually (smoking, poor nutrition, alcohol overconsumption and physical inactivity) and all applicable risks combined, acceptance of referrals and satisfaction with preventive care received. RESULTS Analyses indicated significantly greater increases in 12 of the 18 preventive care delivery outcomes in the intervention compared to the usual care condition from baseline to follow-up, including assessment for all risks combined (risk ratio = 4.00; 95% confidence interval = [1.57, 10.22]), advice for all applicable risks combined (risk ratio = 2.40; 95% confidence interval = [1.89, 6.47]) and offer of referral to applicable telephone services combined (risk ratio = 20.13; 95% confidence interval = [2.56, 158.04]). For each component of care, there was a significant intervention effect for at least one of the individual risk behaviours. Participants reported high levels of satisfaction with preventive care received, ranging from 77% (assessment) to 87% (referral), with no significant differences between conditions. CONCLUSION The intervention had a significant effect on the provision of the majority of recommended elements of preventive care. Further research is needed to maximise its impact, including identifying strategies to increase client uptake.",2020,"RESULTS Analyses indicated significantly greater increases in 12 of the 18 preventive care delivery outcomes in the intervention compared to the usual care condition from baseline to follow-up, including assessment for all risks combined (risk ratio = 4.00; 95% confidence interval = [1.57, 10.22]), advice for all applicable risks combined (risk ratio = 2.40; 95% confidence interval = [1.89, 6.47]) and offer of referral to applicable telephone services combined (risk ratio = 20.13; 95% confidence interval = [2.56, 158.04]).","['one Australian community mental health service', 'Participants ( N \u2009=\u2009811', ""clients' chronic disease risk behaviours""]","['embedding a specialist preventive care clinician', 'preventive care (assessment, advice and referral) for four key risk behaviours individually (smoking, poor nutrition, alcohol overconsumption and physical inactivity', 'usual care (preventive care in routine consultations; n \u2009=\u2009405) or usual care plus the offer of an additional consultation with a specialist preventive care clinician']","['18 preventive care delivery outcomes', 'provision of the majority of recommended elements of preventive care']","[{'cui': 'C0009475', 'cui_str': 'Mental Health Services, Community'}, {'cui': 'C0008942', 'cui_str': 'Clients'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]","[{'cui': 'C0087009', 'cui_str': 'Hospital specialist'}, {'cui': 'C4277527', 'cui_str': 'Preventative Care'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0162429', 'cui_str': 'Undernourished'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C3890554', 'cui_str': 'Physical Inactivity'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C4517768', 'cui_str': '405'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C2090905', 'cui_str': 'Specialist consultation'}]","[{'cui': 'C4277527', 'cui_str': 'Preventative Care'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0013879', 'cui_str': 'Chemical element'}]",811.0,0.0905598,"RESULTS Analyses indicated significantly greater increases in 12 of the 18 preventive care delivery outcomes in the intervention compared to the usual care condition from baseline to follow-up, including assessment for all risks combined (risk ratio = 4.00; 95% confidence interval = [1.57, 10.22]), advice for all applicable risks combined (risk ratio = 2.40; 95% confidence interval = [1.89, 6.47]) and offer of referral to applicable telephone services combined (risk ratio = 20.13; 95% confidence interval = [2.56, 158.04]).","[{'ForeName': 'Caitlin Mc', 'Initials': 'CM', 'LastName': 'Fehily', 'Affiliation': 'School of Psychology, Faculty of Science and Information Technology, The University of Newcastle, Callaghan, NSW, Australia.'}, {'ForeName': 'Kate M', 'Initials': 'KM', 'LastName': 'Bartlem', 'Affiliation': 'School of Psychology, Faculty of Science and Information Technology, The University of Newcastle, Callaghan, NSW, Australia.'}, {'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'Wiggers', 'Affiliation': 'The Australian Prevention Partnership Centre (TAPPC), Sax Institute, Ultimo, NSW, Australia.'}, {'ForeName': 'Paula M', 'Initials': 'PM', 'LastName': 'Wye', 'Affiliation': 'School of Psychology, Faculty of Science and Information Technology, The University of Newcastle, Callaghan, NSW, Australia.'}, {'ForeName': 'Richard V', 'Initials': 'RV', 'LastName': 'Clancy', 'Affiliation': 'Hunter Medical Research Institute, New Lambton Heights, NSW, Australia.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Castle', 'Affiliation': 'Department of Psychiatry, The University of Melbourne, Parkville, VIC, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Wilson', 'Affiliation': 'The Australian Prevention Partnership Centre (TAPPC), Sax Institute, Ultimo, NSW, Australia.'}, {'ForeName': 'Chris E', 'Initials': 'CE', 'LastName': 'Rissel', 'Affiliation': 'School of Public Health, Faculty of Medicine and Health, The University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Wutzke', 'Affiliation': 'The Australian Prevention Partnership Centre (TAPPC), Sax Institute, Ultimo, NSW, Australia.'}, {'ForeName': 'Rebecca K', 'Initials': 'RK', 'LastName': 'Hodder', 'Affiliation': 'School of Psychology, Faculty of Science and Information Technology, The University of Newcastle, Callaghan, NSW, Australia.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Colyvas', 'Affiliation': 'School of Mathematical and Physical Sciences, Faculty of Science and Information Technology, The University of Newcastle, Callaghan, NSW, Australia.'}, {'ForeName': 'Fionna', 'Initials': 'F', 'LastName': 'Murphy', 'Affiliation': 'Hunter Medical Research Institute, New Lambton Heights, NSW, Australia.'}, {'ForeName': 'Jenny A', 'Initials': 'JA', 'LastName': 'Bowman', 'Affiliation': 'School of Psychology, Faculty of Science and Information Technology, The University of Newcastle, Callaghan, NSW, Australia.'}]",The Australian and New Zealand journal of psychiatry,['10.1177/0004867420914741'] 550,32200481,Phase II study of S-1-based sequential combination chemotherapy including oxaliplatin plus bevacizumab and irinotecan with or without cetuximab for metastatic colorectal cancer: the SOBIC trial.,"BACKGROUND Fluorouracil and leucovorin combined with oxaliplatin or irinotecan plus bevacizumab (Bmab) or cetuximab (Cmab) are now widely accepted treatment options as first-line or second-line chemotherapy for metastatic colorectal cancer (mCRC). Sequential chemotherapy with oral 5-FU backbone for mCRC without using central venous ports is beneficial for both patients and physicians. We designed the SOBIC trial to validate the effectiveness of the first- and second-line oral combination chemotherapy for mCRC. PATIENTS AND METHODS From May 2010 through March 2013, 52 patients were enrolled from 47 institutions in the Hyogo Colorectal Cancer Surgery Group. First-line chemotherapy was S-1 + oxaliplatin (SOX) plus Bmab, and second-line chemotherapy after first-line failure was irinotecan + S-1 (IRIS) + Cmab, IRIS + Bmab, or IRIS based on the KRAS status. RESULTS The 50 finally included patients received first-line chemotherapy. Second-line therapy was administered to 20 patients (40%): 12 patients received IRIS + Cmab and 8 patients received IRIS + Bmab. The median follow-up period was 48.6 months (range 35-67 months). The median second progression-free survival was 24.2 months (95% confidence interval [CI] 17.7-35.2). The response rate after first- and second-line chemotherapy was 46.7% and 15%, respectively. The median overall survival was 35.2 months (95% CI: 27.8 to not reached). The main grade 3-4 adverse events were sensory neuropathy (18%) and fatigue (10%). There were no treatment-related deaths. CONCLUSION Sequential S-1-based combination regimens including oxaliplatin, irinotecan, Bmab, and Cmab were beneficial for patients with mCRC.",2020,The median second progression-free survival was 24.2 months (95% confidence interval [CI] 17.7-35.2).,"['From May 2010 through March 2013, 52 patients were enrolled from 47 institutions in the Hyogo Colorectal Cancer Surgery Group', 'metastatic colorectal cancer', 'patients with mCRC', 'metastatic colorectal cancer (mCRC']","['First-line chemotherapy was S-1\u2009+\u2009oxaliplatin (SOX) plus Bmab, and second-line chemotherapy', 'oxaliplatin, irinotecan, Bmab, and Cmab', 'first- and second-line oral combination chemotherapy', 'IRIS\u2009+\u2009Cmab and 8 patients received IRIS\u2009+\u2009Bmab', 'oxaliplatin plus bevacizumab and irinotecan with or without cetuximab', 'Sequential chemotherapy with oral 5-FU backbone', 'irinotecan\u2009+\u2009S-1 (IRIS)\u2009+\u2009Cmab, IRIS\u2009+\u2009Bmab, or IRIS', 'first-line chemotherapy', 'Fluorouracil and leucovorin combined with oxaliplatin or irinotecan plus bevacizumab (Bmab) or cetuximab (Cmab']","['median second progression-free survival', 'median overall survival', 'response rate']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1272753', 'cui_str': 'Institution'}, {'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0346973', 'cui_str': 'Secondary malignant neoplasm of large intestine'}]","[{'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0879262', 'cui_str': 'TS-1 cpd'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0123931', 'cui_str': 'irinotecan'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0013218', 'cui_str': 'Combination Drug Therapy'}, {'cui': 'C0022077', 'cui_str': 'Iris'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0995188', 'cui_str': 'cetuximab'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C2721771', 'cui_str': 'levoleucovorin'}, {'cui': 'C0336789', 'cui_str': 'Combine'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",52.0,0.054877,The median second progression-free survival was 24.2 months (95% confidence interval [CI] 17.7-35.2).,"[{'ForeName': 'Yoshihiko', 'Initials': 'Y', 'LastName': 'Nakamoto', 'Affiliation': 'Department of Surgery, Meiwa Hospital, Nishinomiya, Hyogo, 663-8186, Japan. myy2000815@gmail.com.'}, {'ForeName': 'Masafumi', 'Initials': 'M', 'LastName': 'Noda', 'Affiliation': 'Division of Lower GI Surgery, Department of Surgery, Hyogo College of Medicine, Nishinomiya, Japan.'}, {'ForeName': 'Ryuichi', 'Initials': 'R', 'LastName': 'Mikami', 'Affiliation': 'Department of Surgery, Kobe City Medical Center West Hospital, Kobe, Japan.'}, {'ForeName': 'Yukihiko', 'Initials': 'Y', 'LastName': 'Tokunaga', 'Affiliation': 'Department of Surgery, Japan Post Kyoto Teishin Hospital, Kyoto, Japan.'}, {'ForeName': 'Tatsuo', 'Initials': 'T', 'LastName': 'Okumoto', 'Affiliation': ""Department of Surgery, Himeji St. Mary's Hospital, Himeji, Japan.""}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Kawamura', 'Affiliation': 'Department of Surgery, Kakogawa City Hospital, Kakogawa, Japan.'}, {'ForeName': 'Hidetoshi', 'Initials': 'H', 'LastName': 'Fujiwara', 'Affiliation': 'Department of Surgery, Sanda City Hospital, Sanda, Japan.'}, {'ForeName': 'Sadayuki', 'Initials': 'S', 'LastName': 'Doi', 'Affiliation': 'Department of Surgery, Kawanishi City Hospital, Kawanishi, Japan.'}, {'ForeName': 'Naohiro', 'Initials': 'N', 'LastName': 'Tomita', 'Affiliation': 'Division of Lower GI Surgery, Department of Surgery, Hyogo College of Medicine, Nishinomiya, Japan.'}]",International journal of clinical oncology,['10.1007/s10147-020-01657-2'] 551,31495201,GENESIS: Phase III trial evaluating BL-8040 + G-CSF to mobilize hematopoietic cells for autologous transplant in myeloma.,"Effective hematopoietic cell transplantation relies upon collecting adequate numbers of CD34 + hematopoietic stem cells, typically from peripheral blood. A minimum of ≥2 × 10 6 CD34 + cells/kg are necessary, while transplants of ≥5-6 × 10 6 CD34 + cells/kg are associated with improved hematopoietic recovery. Granulocyte colony stimulating factor (G-CSF) remains the gold standard for hematopoietic stem cell mobilization. However, in randomized trials for autologous-hematopoietic cell transplantation in multiple myeloma, approximately 45% of patients remain unable to optimally mobilize with G-CSF alone despite multiple injections and apheresis days. Therefore, reducing mobilization failures remains an unmet need. The study objective is to evaluate the superiority of one dose of BL-8040 plus G-CSF over placebo plus G-CSF to mobilize ≥6.0 × 10 6 CD34 + cells/kg in up to two apheresis days. ClinicalTrials.gov: NCT03246529.",2019,The study objective is to evaluate the superiority of one dose of BL-8040 plus G-CSF over placebo plus G-CSF to mobilize ≥6.0 × 10 6 CD34 + cells/kg in up to two apheresis days.,['autologous transplant in myeloma'],"['Granulocyte colony stimulating factor (G-CSF', 'BL-8040 plus G-CSF over placebo plus G-CSF', 'autologous-hematopoietic cell transplantation', 'BL-8040\xa0+\xa0G-CSF']",['hematopoietic recovery'],"[{'cui': 'C0559189', 'cui_str': 'Autotransplants'}, {'cui': 'C0026764', 'cui_str': 'Myelomatosis'}]","[{'cui': 'C0018183', 'cui_str': 'Granulocytic cell'}, {'cui': 'C0439158', 'cui_str': 'colonies (qualifier value)'}, {'cui': 'C0079459', 'cui_str': 'G-CSF'}, {'cui': 'C4521107', 'cui_str': 'BL-8040'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C0206153', 'cui_str': 'Cell Transplantation'}]",[],,0.113349,The study objective is to evaluate the superiority of one dose of BL-8040 plus G-CSF over placebo plus G-CSF to mobilize ≥6.0 × 10 6 CD34 + cells/kg in up to two apheresis days.,"[{'ForeName': 'Zachary D', 'Initials': 'ZD', 'LastName': 'Crees', 'Affiliation': 'Department of Medicine, Division of Oncology, Washington University School of Medicine, St. Louis, MO 63108, USA.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Stockerl-Goldstein', 'Affiliation': 'Department of Medicine, Division of Oncology, Washington University School of Medicine, St. Louis, MO 63108, USA.'}, {'ForeName': 'Abi', 'Initials': 'A', 'LastName': 'Vainstein', 'Affiliation': ""BioLineRx, Ltd, Modi'in, Israel.""}, {'ForeName': 'Hemda', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': ""BioLineRx, Ltd, Modi'in, Israel.""}, {'ForeName': 'John F', 'Initials': 'JF', 'LastName': 'DiPersio', 'Affiliation': 'Department of Medicine, Division of Oncology, Washington University School of Medicine, St. Louis, MO 63108, USA.'}]","Future oncology (London, England)",['10.2217/fon-2019-0380'] 552,32402609,Feasibility and efficacy of remotely supervised cranial electrical stimulation for pain in older adults with knee osteoarthritis: A randomized controlled pilot study.,"Cranial electrical stimulation (CES) is a noninvasive brain stimulation technique that has been shown to improve pain. However, few studies have investigated the potential benefits associated with remotely supervised CES in older adults with knee osteoarthritis (OA). The aim of this study was to examine the feasibility and preliminary efficacy of remotely supervised CES via secure videoconferencing software on clinical pain severity, experimental pain sensitivity, and pain-related cortical response in older adults with knee OA. Thirty participants with symptomatic knee OA pain were randomly assigned to receive 10 daily sessions (60 min each) of remotely supervised CES (n = 15) or sham CES (n = 15) over two weeks. We measured clinical pain severity via a Numeric Rating Scale, experimental pain sensitivity (e.g., heat pain sensitivity, pressure pain sensitivity, and conditioned pain modulation) using quantitative sensory testing, and pain-related cortical response via functional near-infrared spectroscopy imaging. We also measured participant satisfaction with treatment using the Client Satisfaction Questionnaire. Active CES significantly reduced scores on the Numeric Rating Scale and increased heat pain threshold, pressure pain thresholds, and conditioned pain modulation. We also found significant changes in pain-related cortical hemodynamic activity after CES. Participants tolerated CES well without serious adverse effects and were satisfied with the treatment. Our findings demonstrate promising clinical efficacy of remotely supervised CES for older adults with knee OA.",2020,"Active CES significantly reduced scores on the Numeric Rating Scale and increased heat pain threshold, pressure pain thresholds, and conditioned pain modulation.","['older adults with knee osteoarthritis (OA', 'older adults with knee OA', 'older adults with knee osteoarthritis', 'Thirty participants with symptomatic knee OA pain']","['Cranial electrical stimulation (CES', 'Active CES', 'remotely supervised CES (n\xa0=\xa015) or sham CES', 'remotely supervised CES via secure videoconferencing software', 'remotely supervised CES', 'remotely supervised cranial electrical stimulation']","['clinical pain severity, experimental pain sensitivity, and pain-related cortical response', 'pain-related cortical hemodynamic activity', 'Numeric Rating Scale and increased heat pain threshold, pressure pain thresholds, and conditioned pain modulation', 'clinical pain severity via a Numeric Rating Scale, experimental pain sensitivity (e.g., heat pain sensitivity, pressure pain sensitivity, and conditioned pain modulation) using quantitative sensory testing, and pain-related cortical response via functional near-infrared spectroscopy imaging', 'Participants tolerated CES well without serious adverse effects', 'Feasibility and efficacy']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]","[{'cui': 'C0037303', 'cui_str': 'Bone structure of cranium'}, {'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C1450048', 'cui_str': 'Videoconferencing'}, {'cui': 'C0037585', 'cui_str': 'Software'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0430838', 'cui_str': 'Quantitative sensory test'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0376519', 'cui_str': 'Near-infrared spectroscopy'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C0037303', 'cui_str': 'Bone structure of cranium'}, {'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",30.0,0.10685,"Active CES significantly reduced scores on the Numeric Rating Scale and increased heat pain threshold, pressure pain thresholds, and conditioned pain modulation.","[{'ForeName': 'Hyochol', 'Initials': 'H', 'LastName': 'Ahn', 'Affiliation': 'Department of Research, Cizik School of Nursing, The University of Texas Health Science Center at Houston, Houston, TX, USA. Electronic address: Hyochol.Ahn@uth.tmc.edu.'}, {'ForeName': 'Kelli', 'Initials': 'K', 'LastName': 'Galle', 'Affiliation': 'Department of Research, Cizik School of Nursing, The University of Texas Health Science Center at Houston, Houston, TX, USA.'}, {'ForeName': 'Kenneth B', 'Initials': 'KB', 'LastName': 'Mathis', 'Affiliation': 'Department of Orthopedic Surgery, School of Medicine, The University of Texas Health Science Center at Houston, Houston, TX, USA.'}, {'ForeName': 'Hongyu', 'Initials': 'H', 'LastName': 'Miao', 'Affiliation': 'Department of Biostatistics and Data Science, School of Public Health, The University of Texas Health Science Center at Houston, Houston, TX, USA.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Montero-Hernandez', 'Affiliation': 'Department of Engineering Technology, University of Houston, Houston, TX, USA.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Jackson', 'Affiliation': 'Department of Research, Cizik School of Nursing, The University of Texas Health Science Center at Houston, Houston, TX, USA.'}, {'ForeName': 'Hsiao-Hui', 'Initials': 'HH', 'LastName': 'Ju', 'Affiliation': 'Department of Research, Cizik School of Nursing, The University of Texas Health Science Center at Houston, Houston, TX, USA.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'McCrackin', 'Affiliation': 'Department of Research, Cizik School of Nursing, The University of Texas Health Science Center at Houston, Houston, TX, USA.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Goodwin', 'Affiliation': 'Department of Research, Cizik School of Nursing, The University of Texas Health Science Center at Houston, Houston, TX, USA.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Hargraves', 'Affiliation': 'Department of Research, Cizik School of Nursing, The University of Texas Health Science Center at Houston, Houston, TX, USA.'}, {'ForeName': 'Bhawna', 'Initials': 'B', 'LastName': 'Jain', 'Affiliation': 'Department of Research, Cizik School of Nursing, The University of Texas Health Science Center at Houston, Houston, TX, USA.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Dinh', 'Affiliation': 'Department of Research, Cizik School of Nursing, The University of Texas Health Science Center at Houston, Houston, TX, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Abdul-Mooti', 'Affiliation': 'Department of Research, Cizik School of Nursing, The University of Texas Health Science Center at Houston, Houston, TX, USA.'}, {'ForeName': 'Lindsey', 'Initials': 'L', 'LastName': 'Park', 'Affiliation': 'Department of Research, Cizik School of Nursing, The University of Texas Health Science Center at Houston, Houston, TX, USA.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Pollonini', 'Affiliation': 'Department of Engineering Technology, University of Houston, Houston, TX, USA.'}]",Journal of clinical neuroscience : official journal of the Neurosurgical Society of Australasia,['10.1016/j.jocn.2020.05.003'] 553,32272022,Circulating MicroRNAs and Treatment Response in Childhood Asthma.,"Rationale: Inhaled corticosteroids (ICS) are key treatments for controlling asthma and preventing asthma attacks. However, the responsiveness to ICS varies among individuals. MicroRNAs (miRNAs) have been lauded for their prognostic utility. Objectives: We hypothesized that circulating miRNAs obtained at baseline/prerandomization in the Childhood Asthma Management Program (CAMP) could serve as biomarkers and biologic mediators of ICS clinical response over the 4-year clinical trial period. Methods: We selected baseline serum samples from 462 CAMP subjects subsequently randomized to either ICS (budesonide) or placebo. Samples underwent small RNA sequencing, and read counts were normalized and filtered by depth and coverage. Linear regression was used to associate miRNAs with change in FEV 1 % (prebronchodilator FEV 1 as a percent predicted) over the 4-year treatment period in both main effects and interaction models. We validated the function of the top associated miRNAs by luciferase reporter assays of glucocorticoid-mediated transrepression and predicted response to ICS through logistic regression models. Measurements and Main Results: We identified 7 miRNAs significantly associated with FEV 1 % change ( P  ≤ 0.05) and 15 miRNAs with significant interaction ( P  ≤ 0.05) to ICS versus placebo treatments. We selected three miRNAs for functional validation, of which hsa-miR-155-5p and hsa-miR-532-5p were significantly associated with changes in dexamethasone-induced transrepression of NF-κB. Combined, these two miRNAs were predictive of ICS response over the course of the clinical trial, with an area under the receiver operating characteristic curve of 0.86. Conclusions: We identified two functional circulating miRNAs predictive of asthma ICS treatment response over time.",2020,We identified 7 miRNAs significantly associated with FEV1% change (p<=0.05) and 15 miRNAs with significant interaction (p<=0.05) to ICS versus placebo treatments.,"['Childhood Asthma', '462 CAMP subjects subsequently randomized to either']","['corticosteroids (ICS', 'placebo', 'ICS (budesonide) or placebo']",['ICS response'],"[{'cui': 'C0264408', 'cui_str': 'Childhood asthma'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}]",462.0,0.187332,We identified 7 miRNAs significantly associated with FEV1% change (p<=0.05) and 15 miRNAs with significant interaction (p<=0.05) to ICS versus placebo treatments.,"[{'ForeName': 'Jiang', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Channing Division of Network Medicine and.'}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'Panganiban', 'Affiliation': 'Program in Molecular and Integrative Physiological Sciences, Harvard T.H. Chan School of Public Health, Boston, Massachusetts; and.'}, {'ForeName': 'Alvin T', 'Initials': 'AT', 'LastName': 'Kho', 'Affiliation': ""Boston Children's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'McGeachie', 'Affiliation': 'Channing Division of Network Medicine and.'}, {'ForeName': 'Leanna', 'Initials': 'L', 'LastName': 'Farnam', 'Affiliation': 'Channing Division of Network Medicine and.'}, {'ForeName': 'Robert P', 'Initials': 'RP', 'LastName': 'Chase', 'Affiliation': 'Channing Division of Network Medicine and.'}, {'ForeName': 'Scott T', 'Initials': 'ST', 'LastName': 'Weiss', 'Affiliation': 'Channing Division of Network Medicine and.'}, {'ForeName': 'Quan', 'Initials': 'Q', 'LastName': 'Lu', 'Affiliation': 'Program in Molecular and Integrative Physiological Sciences, Harvard T.H. Chan School of Public Health, Boston, Massachusetts; and.'}, {'ForeName': 'Kelan G', 'Initials': 'KG', 'LastName': 'Tantisira', 'Affiliation': 'Channing Division of Network Medicine and.'}]",American journal of respiratory and critical care medicine,['10.1164/rccm.201907-1454OC'] 554,32401600,"Efficacy and safety of a booster dose of the meningococcal A, C, W, Y-tetanus toxoid conjugate vaccine administered 10 years after primary vaccination and long-term persistence of tetanus toxoid conjugate or polysaccharide vaccine.","A previous phase 3, randomized, multicenter study showed the immunogenicity of a primary vaccination of subjects aged 11 to 17 years with the quadrivalent meningococcal vaccine conjugated to tetanus toxoid (MenACWY-TT) or the quadrivalent meningococcal polysaccharide vaccine (MenACWY-PS). This extension study evaluated the safety and immunogenicity of a MenACWY-TT booster 10 years after receiving a primary dose of either MenACWY-TT or MenACWY-PS. The primary immunogenicity endpoint was booster response, evaluated using serum bactericidal antibody assays with rabbit complement (rSBA), 1 month postbooster. Safety endpoints included the percentage of subjects experiencing local and general adverse events (AEs) ≤4 days after MenACWY-TT booster. Of 229 subjects enrolled, 169 and 58 in the MenACWY-TT and MenACWY-PS groups, respectively, completed the booster phase. The 1 month postbooster response for each serogroup ranged from 81.5% to 95.7% for MenACWY-TT and 66.7% to 94.1% for MenACWY-PS. Similar percentages of MenACWY-TT and MenACWY-PS recipients had a booster response to serogroups A, W, and Y, whereas more MenACWY-TT recipients than MenACWY-PS recipients had a booster response to serogroup C. For the MenACWY-TT and MenACWY-PS groups, respectively, the MenACWY-TT booster elicited rSBA titers ≥1:8 in 100% and ≥98.0% of subjects across all serogroups; 100% and ≥96.1% of all subjects had titers ≥1:128. No new safety signals were observed during the booster phase. In conclusion, a MenACWY-TT booster dose after receiving either a primary dose of MenACWY-TT or MenACWY-PS elicited robust immune responses and was well tolerated. Functional antibody responses last up to 10 years after primary MenACWY-TT vaccination.",2020,"Similar percentages of MenACWY-TT and MenACWY-PS recipients had a booster response to serogroups A, W, and Y, whereas more MenACWY-TT recipients than MenACWY-PS recipients had a booster response to serogroup C. For the MenACWY-TT and MenACWY-PS groups, respectively, the MenACWY-TT booster elicited rSBA titers ≥1:8 in 100% and ≥98.0% of subjects across all serogroups; 100% and ≥96.1% of all subjects had titers ≥1:128.","['229 subjects enrolled, 169 and 58 in the MenACWY-TT and MenACWY-PS groups, respectively, completed the booster phase', 'subjects aged 11 to 17\xa0years with the']","['quadrivalent meningococcal vaccine conjugated to tetanus toxoid (MenACWY-TT) or the quadrivalent meningococcal polysaccharide vaccine (MenACWY-PS', 'tetanus toxoid conjugate or polysaccharide vaccine', 'MenACWY-TT or MenACWY-PS']","['new safety signals', 'booster response, evaluated using serum bactericidal antibody assays with rabbit complement (rSBA), 1\xa0month postbooster', 'tolerated', 'Efficacy and safety', 'safety and immunogenicity', 'Functional antibody responses', 'percentage of subjects experiencing local and general adverse events (AEs']","[{'cui': 'C3529849', 'cui_str': 'tetravalent meningococcal serogroups A, C, W-135 and Y tetanus toxoid conjugate vaccine'}, {'cui': 'C2003457', 'cui_str': 'MenACWY'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0020975', 'cui_str': 'Booster vaccination'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0700144', 'cui_str': 'Meningococcus vaccine'}, {'cui': 'C0301869', 'cui_str': 'Conjugate'}, {'cui': 'C0039620', 'cui_str': 'Tetanus vaccine'}, {'cui': 'C3529849', 'cui_str': 'tetravalent meningococcal serogroups A, C, W-135 and Y tetanus toxoid conjugate vaccine'}, {'cui': 'C0127526', 'cui_str': 'Meningococcal polysaccharide vaccine'}, {'cui': 'C2003457', 'cui_str': 'MenACWY'}, {'cui': 'C0032594', 'cui_str': 'Polysaccharide'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}, {'cui': 'C0020975', 'cui_str': 'Booster vaccination'}, {'cui': 'C2936353', 'cui_str': 'Serum Bactericidal Antibody Assays'}, {'cui': 'C0324889', 'cui_str': 'Oryctolagus cuniculus'}, {'cui': 'C0009498', 'cui_str': 'Complement'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0003261', 'cui_str': 'Antibody Production'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",229.0,0.0353615,"Similar percentages of MenACWY-TT and MenACWY-PS recipients had a booster response to serogroups A, W, and Y, whereas more MenACWY-TT recipients than MenACWY-PS recipients had a booster response to serogroup C. For the MenACWY-TT and MenACWY-PS groups, respectively, the MenACWY-TT booster elicited rSBA titers ≥1:8 in 100% and ≥98.0% of subjects across all serogroups; 100% and ≥96.1% of all subjects had titers ≥1:128.","[{'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Quiambao', 'Affiliation': 'Clinical Research Division, Research Institute for Tropical Medicine , Alabang, Muntinlupa City, Philippines.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Peyrani', 'Affiliation': 'Pfizer Vaccine Clinical Research and Development, Pfizer Inc , Collegeville, PA, USA.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Li', 'Affiliation': 'Pfizer Vaccine Clinical Research and Development, Pfizer Inc , Collegeville, PA, USA.'}, {'ForeName': 'Mark W', 'Initials': 'MW', 'LastName': 'Cutler', 'Affiliation': 'Pfizer Vaccine Research and Development, Pfizer Inc , Pearl River, NY, USA.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Van Der Wielen', 'Affiliation': 'Vaccines R & D, GlaxoSmithKline , Wavre, Belgium.'}, {'ForeName': 'John L', 'Initials': 'JL', 'LastName': 'Perez', 'Affiliation': 'Pfizer Vaccine Clinical Research and Development, Pfizer Inc , Collegeville, PA, USA.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Webber', 'Affiliation': 'Pfizer Vaccine Clinical Research and Development, Pfizer Inc , Hurley, UK.'}]",Human vaccines & immunotherapeutics,['10.1080/21645515.2020.1744363'] 555,32183815,Effectiveness of prescribing physical activity in parks to improve health and wellbeing - the park prescription randomized controlled trial.,"BACKGROUND Programs promoting population health through physical activity (PA) and exposure to nature are popular, but few have been evaluated in randomized-controlled trials (RCTs). OBJECTIVE To investigate the effectiveness of a park prescription intervention (PPI) for improving total moderate-to-vigorous PA (MVPA), other PA related behaviors, quality of life (QoL) and cardio-metabolic health among adults. METHODS Healthy individuals aged 40 to 65 years were recruited through community health screenings and randomly assigned to 1) PPI: face-to-face Park Prescription + invitation to weekly exercise sessions in parks, or 2) control: standard PA materials. After the six-month intervention, participants completed accelerometer assessments, questionnaires on health behaviors and QoL, and health screenings. Independent sample t-tests were used to compare outcomes between groups, with secondary analysis adjusted for co-variates via multiple linear regression. A p-value <0.05 was considered statistically significant. RESULTS Eighty participants were allocated to each group. Participants with mean age of 51.1 (Standard Deviation: 6.3) years were predominantly female (79%) and of Chinese ethnicity (81%). Participation in the group exercise started at 48% and declined to 24% by week 26. At six-months, 145 (91%) participants attended health screenings for outcome measure collection, and 126 (79%) provided valid accelerometer data. Time spent in MVPA favored the PPI group but this difference was not statistically significant (4.4 (- 43.8, 52.7) minutes/week; when removing 2 extreme outliers 26.8 (- 9.7, 63.4) minutes/week). Time spent in parks (147.5 (2.1, 292.9) minutes/month), PA in parks (192.5 (59.5, 325.5) minutes/month), and recreational PA (48.7 (1.4, 96.0) minutes/week) were significantly greater in the PPI group. PPI also significantly improved psychological QoL (4.0 (0.0, 8.0). DISCUSSION PPI improved park use, PA in parks, recreational PA, and psychological QoL but not total MVPA. Future RCTs' are warranted to investigate PPI in different target populations and to provide further evidence for improvements in health outcomes. TRIAL REGISTRATION ClinicalTrials.gov NCT02615392, 26 November 2015.",2020,"Time spent in MVPA favored the PPI group but this difference was not statistically significant (4.4 (- 43.8, 52.7) minutes/week; when removing 2 extreme outliers 26.8 (- 9.7, 63.4) minutes/week).","['6.3) years were predominantly female (79%) and of Chinese ethnicity (81', 'Healthy individuals aged 40 to 65\u2009years', 'Eighty participants', 'adults', 'Participants with mean age of 51.1 (Standard Deviation', '26 November 2015']","['park prescription intervention (PPI', 'prescribing physical activity', 'community health screenings and randomly assigned to 1) PPI: face-to-face Park Prescription + invitation to weekly exercise sessions in parks, or 2) control: standard PA materials']","['recreational PA', 'psychological QoL', 'health behaviors and QoL, and health screenings', 'Time spent in MVPA', 'Time spent in parks', 'total moderate-to-vigorous PA (MVPA), other PA related behaviors, quality of life (QoL) and cardio-metabolic health', 'park use, PA in parks, recreational PA, and psychological QoL']","[{'cui': 'C4319697', 'cui_str': '6.3'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0243103', 'cui_str': 'ethnicity'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}]","[{'cui': 'C0562547', 'cui_str': 'Park (environment)'}, {'cui': 'C0033080', 'cui_str': 'Prescriptions'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0034019', 'cui_str': 'Community Health'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0520510', 'cui_str': 'Material (attribute)'}]","[{'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0018687'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0562547', 'cui_str': 'Park (environment)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0034380'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1947944', 'cui_str': 'Use'}]",80.0,0.0981709,"Time spent in MVPA favored the PPI group but this difference was not statistically significant (4.4 (- 43.8, 52.7) minutes/week; when removing 2 extreme outliers 26.8 (- 9.7, 63.4) minutes/week).","[{'ForeName': 'Falk', 'Initials': 'F', 'LastName': 'Müller-Riemenschneider', 'Affiliation': 'Saw Swee Hock School of Public Health, National University of Singapore, Tahir Foundation Building, Block MD1, 12 Science Drive 2, #09-01V, Singapore, 117549, Singapore. ephmf@nuhs.edu.sg.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Petrunoff', 'Affiliation': 'Saw Swee Hock School of Public Health, National University of Singapore, Tahir Foundation Building, Block MD1, 12 Science Drive 2, #09-01V, Singapore, 117549, Singapore.'}, {'ForeName': 'Jiali', 'Initials': 'J', 'LastName': 'Yao', 'Affiliation': 'Saw Swee Hock School of Public Health, National University of Singapore, Tahir Foundation Building, Block MD1, 12 Science Drive 2, #09-01V, Singapore, 117549, Singapore.'}, {'ForeName': 'Alwyn', 'Initials': 'A', 'LastName': 'Ng', 'Affiliation': 'Saw Swee Hock School of Public Health, National University of Singapore, Tahir Foundation Building, Block MD1, 12 Science Drive 2, #09-01V, Singapore, 117549, Singapore.'}, {'ForeName': 'Angelia', 'Initials': 'A', 'LastName': 'Sia', 'Affiliation': 'Centre for Urban Greenery & Ecology, National Parks Board Singapore, 1E Cluny Rd, Singapore Botanic Gardens, Singapore, 259569, Singapore.'}, {'ForeName': 'Anbumalar', 'Initials': 'A', 'LastName': 'Ramiah', 'Affiliation': 'Health for Life Centre, Alexandra Health Pte Ltd, 90 Yishun Central, Khoo Teck Puat Hospital, Singapore, 768828, Singapore.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Wong', 'Affiliation': 'Health for Life Centre, Alexandra Health Pte Ltd, 90 Yishun Central, Khoo Teck Puat Hospital, Singapore, 768828, Singapore.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Han', 'Affiliation': 'Health for Life Centre, Alexandra Health Pte Ltd, 90 Yishun Central, Khoo Teck Puat Hospital, Singapore, 768828, Singapore.'}, {'ForeName': 'Bee Choo', 'Initials': 'BC', 'LastName': 'Tai', 'Affiliation': 'Saw Swee Hock School of Public Health, National University of Singapore, Tahir Foundation Building, Block MD1, 12 Science Drive 2, #09-01V, Singapore, 117549, Singapore.'}, {'ForeName': 'Léonie', 'Initials': 'L', 'LastName': 'Uijtdewilligen', 'Affiliation': 'Saw Swee Hock School of Public Health, National University of Singapore, Tahir Foundation Building, Block MD1, 12 Science Drive 2, #09-01V, Singapore, 117549, Singapore.'}]",The international journal of behavioral nutrition and physical activity,['10.1186/s12966-020-00941-8'] 556,30985534,Metabolic Syndrome and the Effectiveness of Low-dose Aspirin on Reproductive Outcomes.,"BACKGROUND Metabolic syndrome is associated with increases in both inflammation and aspirin resistance, but effectiveness of aspirin in improving reproductive health among women with metabolic syndrome is unknown. We evaluated the effectiveness of low-dose aspirin in improving reproductive outcomes across metabolic syndrome score. METHODS The EAGeR trial randomly assigned 1228 women with a history of pregnancy loss to receive 81 mg aspirin or placebo for up to six menstrual cycles of attempting pregnancy and, if they became pregnant, throughout pregnancy. We assessed components of metabolic syndrome at enrollment, including: waist circumference ≥88 cm, triglycerides ≥150 mg/dl, high-density lipoprotein ≤50 mg/dl, blood pressure ≥130 mmHg systolic or ≥85 mmHg diastolic, and glucose ≥100 mg/dl. We summed components to calculate metabolic syndrome score. RESULTS A total of 229 participants (20%) met full criteria for metabolic syndrome, 207 (18%) had two components, 366 (31%) one component, and 372 (32%) no components. Among those without any component of metabolic syndrome, aspirin was associated with 10.7 [95% confidence interval (CI) = 1.2, 20.2] more pregnancies and 13.7 (95% CI = 3.3, 24.0) more live births per 100 couples. Effects were attenuated as metabolic syndrome score increased and we observed no clear effect of aspirin on pregnancy or live birth among women with metabolic syndrome. CONCLUSIONS Low-dose aspirin is most effective in increasing pregnancy and live birth among women with no or few components of metabolic syndrome. Reduced effectiveness among women with metabolic syndrome may be due to differences in effective dose or aspirin resistance.",2019,"Effects were attenuated as metabolic syndrome score increased and we observed no clear effect of aspirin on pregnancy or live birth among women with metabolic syndrome. ","['1228 women with a history of pregnancy loss to receive 81\u2009mg', 'women with no or few components of metabolic syndrome', 'women with metabolic syndrome', '229 participants (20%) met full criteria for metabolic syndrome, 207 (18%) had two components, 366 (31%) one component, and 372 (32%) no components', 'metabolic syndrome at enrollment, including: waist circumference ≥88\u2009cm, triglycerides ≥150\u2009mg/dl, high-density lipoprotein ≤50\u2009mg/dl, blood pressure ≥130 mmHg systolic or ≥85 mmHg diastolic, and glucose ≥100\u2009mg/dl']","['Low-dose Aspirin', 'aspirin or placebo', 'low-dose aspirin', 'aspirin']","['metabolic syndrome score', 'pregnancy or live birth', 'Reproductive Outcomes']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0032967', 'cui_str': 'Pregnancy History'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0524620', 'cui_str': 'Metabolic Syndrome X'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement (procedure)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0439475', 'cui_str': 'torr (qualifier value)'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}]","[{'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0524620', 'cui_str': 'Metabolic Syndrome X'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0481667', 'cui_str': 'Live Birth'}]",1228.0,0.171766,"Effects were attenuated as metabolic syndrome score increased and we observed no clear effect of aspirin on pregnancy or live birth among women with metabolic syndrome. ","[{'ForeName': 'Carrie J', 'Initials': 'CJ', 'LastName': 'Nobles', 'Affiliation': 'From the Epidemiology Branch, Division of Intramural Population Health Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, MD.'}, {'ForeName': 'Pauline', 'Initials': 'P', 'LastName': 'Mendola', 'Affiliation': 'From the Epidemiology Branch, Division of Intramural Population Health Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, MD.'}, {'ForeName': 'Sunni L', 'Initials': 'SL', 'LastName': 'Mumford', 'Affiliation': 'From the Epidemiology Branch, Division of Intramural Population Health Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, MD.'}, {'ForeName': 'Keewan', 'Initials': 'K', 'LastName': 'Kim', 'Affiliation': 'From the Epidemiology Branch, Division of Intramural Population Health Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, MD.'}, {'ForeName': 'Lindsey', 'Initials': 'L', 'LastName': 'Sjaarda', 'Affiliation': 'From the Epidemiology Branch, Division of Intramural Population Health Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, MD.'}, {'ForeName': 'Micah', 'Initials': 'M', 'LastName': 'Hill', 'Affiliation': 'Department of Obstetrics and Gynecology, Walter Reed National Military Medical Center, Bethesda, MD.'}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Silver', 'Affiliation': 'Obstetrics and Gynecology, School of Medicine, University of Utah, Salt Lake City, UT.'}, {'ForeName': 'Ashley I', 'Initials': 'AI', 'LastName': 'Naimi', 'Affiliation': 'Department of Epidemiology, School of Public Health, University of Pittsburgh, Pittsburgh, PA.'}, {'ForeName': 'Neil J', 'Initials': 'NJ', 'LastName': 'Perkins', 'Affiliation': 'From the Epidemiology Branch, Division of Intramural Population Health Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, MD.'}, {'ForeName': 'Enrique F', 'Initials': 'EF', 'LastName': 'Schisterman', 'Affiliation': 'From the Epidemiology Branch, Division of Intramural Population Health Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, MD.'}]","Epidemiology (Cambridge, Mass.)",['10.1097/EDE.0000000000001019'] 557,32203109,Effects of an antenatal dietary intervention in women with obesity or overweight on child outcomes at 3-5 years of age: LIMIT randomised trial follow-up.,"While the effects of an antenatal dietary intervention for women with obesity or overweight on pregnancy and newborn health have been extensively studied, the longer-term effects into childhood are unknown. We followed children born to women who participated in the LIMIT randomised trial, where pregnant women were randomised to an antenatal dietary and lifestyle intervention or standard antenatal care. Our aim was to assess the effect of the intervention, on child outcomes at 3-5 years of age on children whose mothers provided consent. We assessed 1418 (Lifestyle Advice n = 727; Standard Care n = 691) (66.9%) of the 2121 eligible children. There were no statistically significant differences in the incidence of child BMI z-score >85th centile for children born to women in the Lifestyle Advice Group, compared with the Standard Care group (Lifestyle Advice 444 (41.73%) versus Standard Care 417 (39.51%); adjusted relative risk (aRR) 1.05; 95% confidence intervals 0.93-1.19; p = 0.42). There were no significant effects on measures of child growth, adiposity, neurodevelopment, or dietary intake. There is no evidence that an antenatal dietary intervention altered child growth and adiposity at age 3-5 years. This cohort of children remains at high risk of obesity, and warrants ongoing follow-up.",2020,"There were no statistically significant differences in the incidence of child BMI z-score >85th centile for children born to women in the Lifestyle Advice Group, compared with the Standard Care group (Lifestyle Advice 444 (41.73%) versus Standard Care 417 (39.51%); adjusted relative risk (aRR) 1.05; 95% confidence intervals 0.93-1.19; p = 0.42).","['1418 (Lifestyle Advice n\u2009=\u2009727; Standard Care n\u2009=\u2009691) (66.9%) of the 2121 eligible children', 'children born to women who participated in the LIMIT randomised trial, where pregnant women', 'women with obesity or overweight on child outcomes at 3-5 years of age', 'women with obesity or overweight on pregnancy and newborn health']","['antenatal dietary and lifestyle intervention or standard antenatal care', 'antenatal dietary intervention']","['child growth and adiposity', 'incidence of child BMI z-score >85th centile', 'child growth, adiposity, neurodevelopment, or dietary intake']","[{'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439801', 'cui_str': 'Limited (qualifier value)'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C4042838', 'cui_str': 'Health of Newborn Infants'}]","[{'cui': 'C2828394', 'cui_str': 'Antenatal (qualifier value)'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0033052', 'cui_str': 'Antenatal Care'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C1563743', 'cui_str': 'Adiposis'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}]",2121.0,0.104863,"There were no statistically significant differences in the incidence of child BMI z-score >85th centile for children born to women in the Lifestyle Advice Group, compared with the Standard Care group (Lifestyle Advice 444 (41.73%) versus Standard Care 417 (39.51%); adjusted relative risk (aRR) 1.05; 95% confidence intervals 0.93-1.19; p = 0.42).","[{'ForeName': 'Jodie M', 'Initials': 'JM', 'LastName': 'Dodd', 'Affiliation': ""The University of Adelaide, Department of Women's and Children's Health and The Robinson Research Institute, Adelaide, SA, Australia. jodie.dodd@adelaide.edu.au.""}, {'ForeName': 'Andrea R', 'Initials': 'AR', 'LastName': 'Deussen', 'Affiliation': ""The University of Adelaide, Department of Women's and Children's Health and The Robinson Research Institute, Adelaide, SA, Australia.""}, {'ForeName': 'Jennie', 'Initials': 'J', 'LastName': 'Louise', 'Affiliation': ""The University of Adelaide, Department of Women's and Children's Health and The Robinson Research Institute, Adelaide, SA, Australia.""}]",International journal of obesity (2005),['10.1038/s41366-020-0560-4'] 558,32402523,Treatment Adequacy and Adherence as Predictors of Depression Response in Primary Care.,"OBJECTIVE Primary care is the de facto mental health system in the United States where physicians treat large numbers of depressed older adults with antidepressant medication. This study aimed to examine whether antidepressant dosage adequacy and patient adherence are associated with depression response among middle-aged and older adults prescribed with antidepressants by their primary care provider. DESIGN A secondary analysis was conducted on a sample drawn from a randomized controlled trial comparing Treatment as Usual to Treatment Initiation Program, an adherence intervention. Treatment Initiation Program improved adherence but not depression compared to Treatment as Usual (Sirey et al., 2017). For this analysis, we examined dosing adequacy and adherence at 6 and 12 weeks as predictors of depression response in both groups at 12 and 24 weeks. SETTING Primary care practices. PARTICIPANTS One hundred eighty-seven older adults with depression prescribed an antidepressant for depression by their primary care provider. MEASUREMENTS Depression response was defined as 50% reduction on the Hamilton Rating Scale for Depression. Adherence was defined as taking 80% of doses at follow-up interviews (6 and 12 weeks). Patient-reported dosage and duration of antidepressant therapy was collected using the Composite Antidepressant Score (adequacy score of >3) at follow-up. RESULTS Greater adherence, but not receipt of adequate dosage, was associated with higher likelihood of treatment response at both 12 (Odds ratio (OR) = 2.63; 95% Confidence Interval (CI), 1.19-5.84) and 24 weeks (OR = 3.09; 95% CI, 1.46-6.55). CONCLUSION As physicians prescribe antidepressants to the diverse group of adults seen in primary care, special attention to patients' views and approach to adherence may improve depression outcomes.",2020,"Greater adherence, but not receipt of adequate dosage, was associated with higher likelihood of treatment response at both 12 (Odds ratio (OR) = 2.63; 95% Confidence Interval (CI), 1.19-5.84) and 24 weeks (OR = 3.09; 95% CI, 1.46-6.55). ","['middle-aged and older adults prescribed with antidepressants by their primary care provider', 'One hundred eighty-seven older adults with depression prescribed an antidepressant for depression by their primary care provider', 'depressed older adults with antidepressant medication', 'Primary care practices']",[],"['Greater adherence', 'Depression response', 'Hamilton Rating Scale for Depression', 'depression response', 'Adherence']","[{'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C2239117', 'cui_str': 'Prescription of drug'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant'}, {'cui': 'C2735026', 'cui_str': 'Primary care provider'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C4517895', 'cui_str': '87'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}]",[],"[{'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}]",187.0,0.0742356,"Greater adherence, but not receipt of adequate dosage, was associated with higher likelihood of treatment response at both 12 (Odds ratio (OR) = 2.63; 95% Confidence Interval (CI), 1.19-5.84) and 24 weeks (OR = 3.09; 95% CI, 1.46-6.55). ","[{'ForeName': 'Jo Anne', 'Initials': 'JA', 'LastName': 'Sirey', 'Affiliation': 'Department of Psychiatry, Weill Cornell Medical College (JAS, AW, NS, PZ, GA). Electronic address: jsirey@med.cornell.edu.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Woods', 'Affiliation': 'Department of Psychiatry, Weill Cornell Medical College (JAS, AW, NS, PZ, GA).'}, {'ForeName': 'Nili', 'Initials': 'N', 'LastName': 'Solomonov', 'Affiliation': 'Department of Psychiatry, Weill Cornell Medical College (JAS, AW, NS, PZ, GA).'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Evans', 'Affiliation': 'Department of Healthcare Policy & Research, Weill Cornell Medicine (LE, SB).'}, {'ForeName': 'Samprit', 'Initials': 'S', 'LastName': 'Banerjee', 'Affiliation': 'Department of Healthcare Policy & Research, Weill Cornell Medicine (LE, SB).'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Zanotti', 'Affiliation': 'Department of Psychiatry, Weill Cornell Medical College (JAS, AW, NS, PZ, GA).'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Alexopoulos', 'Affiliation': 'Department of Psychiatry, Weill Cornell Medical College (JAS, AW, NS, PZ, GA).'}, {'ForeName': 'Helen C', 'Initials': 'HC', 'LastName': 'Kales', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of California at Davis (HCK).'}]",The American journal of geriatric psychiatry : official journal of the American Association for Geriatric Psychiatry,['10.1016/j.jagp.2020.04.014'] 559,30738059,Comparison of Piezosurgery and Conventional Osteotomy Post Rhinoplasty Morbidities: A Double-Blind Randomized Controlled Trial.,"PURPOSE Several approaches have been introduced to decrease soft tissue injury during rhinoplasty. The piezoelectric ultrasonic device can be used to perform more precise bone surgeries and avoid soft tissue perforation. This study compared postoperative pain, edema, and ecchymosis in internal lateral osteotomies performed by the piezosurgery device with the conventional method. MATERIALS AND METHODS In this double-blind randomized controlled trial, patients who underwent an osteotomy of the lateral nasal walls were randomly assigned to a conventional intranasal lateral osteotomy method using an osteotome (group A) or an internal lateral osteotomy using the piezosurgery device (group B). Postoperative pain was assessed 1, 2, and 3 days after surgery using the visual analog scale, edema was graded based on a 4-grade visual scale, and ecchymosis was assessed by a 3-grade visual scale 2 and 7 days after surgery. Data were analyzed by the Mann-Whitney U test with a significance level of .05. RESULTS Overall, 20 patients (10 per group) were included in this study. Postoperative pain and ecchymosis were significantly decreased in group B at all time points (P < .05). Edema was significantly decreased in group B after 2 days (P = .043), although the difference was not significant after 7 days (P = .280). CONCLUSIONS Performing an internal lateral osteotomy using the piezosurgery device is associated with decreased postoperative pain, edema, and ecchymosis compared with a conventional osteotomy.",2019,Postoperative pain and ecchymosis were significantly decreased in group B at all time points (P < .05).,"['20 patients (10 per group) were included in this study', 'patients who underwent an osteotomy of the lateral nasal walls']","['conventional intranasal lateral osteotomy method using an osteotome (group A) or an internal lateral osteotomy using the piezosurgery device', 'Piezosurgery and Conventional Osteotomy Post']","['postoperative pain, edema, and ecchymosis', 'visual analog scale, edema was graded based on a 4-grade visual scale, and ecchymosis', 'Postoperative pain and ecchymosis', 'Edema', 'Postoperative pain', 'Rhinoplasty Morbidities']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0029468', 'cui_str': 'Osteotomy'}, {'cui': 'C0456482', 'cui_str': 'Structure of lateral nasal wall'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach (qualifier value)'}, {'cui': 'C0205093', 'cui_str': 'Lateral (qualifier value)'}, {'cui': 'C0029468', 'cui_str': 'Osteotomy'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0182092', 'cui_str': 'Osteotome (physical object)'}, {'cui': 'C0441835', 'cui_str': 'Group A (qualifier value)'}, {'cui': 'C0205102', 'cui_str': 'Internal (qualifier value)'}, {'cui': 'C3178856', 'cui_str': 'Piezo-Electric Surgery'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}]","[{'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0013604', 'cui_str': 'Hydrops'}, {'cui': 'C0013491', 'cui_str': 'Ecchymosis'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0035467', 'cui_str': 'Plastic operation on nose'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}]",20.0,0.152041,Postoperative pain and ecchymosis were significantly decreased in group B at all time points (P < .05).,"[{'ForeName': 'Hamid Reza', 'Initials': 'HR', 'LastName': 'Fallahi', 'Affiliation': 'Assistant Professor, Department of Oral and Maxillofacial Surgery, Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Seied Omid', 'Initials': 'SO', 'LastName': 'Keyhan', 'Affiliation': 'Oral and Maxillofacial surgeon as a private practitioner.'}, {'ForeName': 'Tirbod', 'Initials': 'T', 'LastName': 'Fattahi', 'Affiliation': 'Chief and Professor, Division of Oral and Maxillofacial Surgery, University of Florida, Jacksonville, FL.'}, {'ForeName': 'Amir Khosrow', 'Initials': 'AK', 'LastName': 'Mohiti', 'Affiliation': 'Resident, Department of Oral and Maxillofacial Surgery, Jundishapur University of Medical Sciences, Ahvaz, Iran. Electronic address: amir.khosro.m@gmail.com.'}]",Journal of oral and maxillofacial surgery : official journal of the American Association of Oral and Maxillofacial Surgeons,['10.1016/j.joms.2019.01.004'] 560,32403115,Delayed iron does not alter cognition or behavior among children with severe malaria and iron deficiency.,"BACKGROUND Malaria and iron deficiency (ID) in childhood are both associated with cognitive and behavioral dysfunction. The current standard of care for children with malaria and ID is concurrent antimalarial and iron therapy. Delaying iron therapy until inflammation subsides could increase iron absorption but also impair cognition. METHODS In this study, Ugandan children 18 months to 5 years old with cerebral malaria (CM, n = 79), severe malarial anemia (SMA, n = 77), or community children (CC, n = 83) were enrolled and tested for ID. Children with ID were randomized to immediate vs. 28-day delayed iron therapy. Cognitive and neurobehavioral outcomes were assessed at baseline and 6 and 12 months (primary endpoint) after enrollment. RESULTS All children with CM or SMA and 35 CC had ID (zinc protoporphyrin concentration ≥80 μmol/mol heme). No significant differences were seen at 12-month follow-up in overall cognitive ability, attention, associative memory, or behavioral outcomes between immediate and delayed iron treatment (mean difference (standard error of mean) ranged from -0.2 (0.39) to 0.98 (0.5), all P ≥ 0.06). CONCLUSIONS Children with CM or SMA and ID who received immediate vs. delayed iron therapy had similar cognitive and neurobehavioral outcomes at 12-month follow-up. IMPACT The optimal time to provide iron therapy in children with severe malaria is not known. The present study shows that delay of iron treatment to 28 days after the malaria episode, does not lead to worse cognitive or behavioral outcomes at 12-month follow-up. The study contributes new data to the ongoing discussion of how best to treat ID in children with severe malaria.",2020,"No significant differences were seen at 12-month follow-up in overall cognitive ability, attention, associative memory, or behavioral outcomes between immediate and delayed iron treatment (mean difference (standard error of mean) ranged from -0.2 (0.39) to 0.98 (0.5), all P ≥ 0.06). ","['children with severe malaria and iron deficiency', 'Ugandan children 18 months to 5 years old with cerebral malaria (CM, n\u2009=\u200979), severe malarial anemia (SMA, n\u2009=\u200977), or community children (CC, n\u2009=\u200983) were enrolled and tested for ID', 'Children with ID', 'children with severe malaria']",['immediate vs. 28-day delayed iron therapy'],"['cognitive and neurobehavioral outcomes', 'Cognitive and neurobehavioral outcomes', 'cognition or behavior', 'cognitive or behavioral outcomes', 'overall cognitive ability, attention, associative memory, or behavioral outcomes between immediate and delayed iron treatment']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C2747816', 'cui_str': 'Complicated malaria'}, {'cui': 'C0162316', 'cui_str': 'Iron deficiency anemia'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0024534', 'cui_str': 'Cerebral malaria'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0026847', 'cui_str': 'Spinal muscular atrophy'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]","[{'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",83.0,0.106877,"No significant differences were seen at 12-month follow-up in overall cognitive ability, attention, associative memory, or behavioral outcomes between immediate and delayed iron treatment (mean difference (standard error of mean) ranged from -0.2 (0.39) to 0.98 (0.5), all P ≥ 0.06). ","[{'ForeName': 'Andrew S', 'Initials': 'AS', 'LastName': 'Ssemata', 'Affiliation': 'Department of Psychiatry, College of Health Sciences, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Meredith', 'Initials': 'M', 'LastName': 'Hickson', 'Affiliation': ""Division of General Pediatrics, Children's Hospital of Philadelphia, Philadelphia, PA, USA.""}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Ssenkusu', 'Affiliation': 'Department of Epidemiology and Biostatistics, College of Health Sciences, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Sarah E', 'Initials': 'SE', 'LastName': 'Cusick', 'Affiliation': 'Department of Pediatrics, University of Minnesota Medical School, Minneapolis, MN, USA.'}, {'ForeName': 'Noeline', 'Initials': 'N', 'LastName': 'Nakasujja', 'Affiliation': 'Department of Psychiatry, College of Health Sciences, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Robert O', 'Initials': 'RO', 'LastName': 'Opoka', 'Affiliation': 'Department of Pediatrics and Child Health, College of Health Sciences, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Kroupina', 'Affiliation': 'Department of Pediatrics, University of Minnesota Medical School, Minneapolis, MN, USA.'}, {'ForeName': 'Michael K', 'Initials': 'MK', 'LastName': 'Georgieff', 'Affiliation': 'Department of Pediatrics, University of Minnesota Medical School, Minneapolis, MN, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Bangirana', 'Affiliation': 'Department of Psychiatry, College of Health Sciences, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Chandy C', 'Initials': 'CC', 'LastName': 'John', 'Affiliation': 'Department of Pediatrics, University of Minnesota Medical School, Minneapolis, MN, USA. chjohn@iu.edu.'}]",Pediatric research,['10.1038/s41390-020-0957-8'] 561,32403118,Proof of mechanism and target engagement of glutamatergic drugs for the treatment of schizophrenia: RCTs of pomaglumetad and TS-134 on ketamine-induced psychotic symptoms and pharmacoBOLD in healthy volunteers.,"Glutamate neurotransmission is a prioritized target for antipsychotic drug development. Two metabotropic glutamate receptor 2/3 (mGluR2/3) agonists (pomaglumetad [POMA] and TS-134) were assessed in two Phase Ib proof of mechanism studies of comparable designs and using identical clinical assessments and pharmacoBOLD methodology. POMA was examined in a randomized controlled trial under double-blind conditions for 10-days at doses of 80 or 320 mg/d POMA versus placebo (1:1:1 ratio). The TS-134 trial was a randomized, single-blind, 6-day study of 20 or 60 mg/d TS-134 versus placebo (5:5:2 ratio). Primary outcomes were ketamine-induced changes in pharmacoBOLD in the dorsal anterior cingulate cortex (dACC) and symptoms reflected on the Brief Psychiatric Rating Scale (BPRS). Both trials were conducted contemporaneously. 95 healthy volunteers were randomized to POMA and 63 to TS-134. High-dose POMA significantly reduced ketamine-induced BPRS total symptoms within and between-groups (p < 0.01, d = -0.41; p = 0.04, d = -0.44, respectively), but neither POMA dose significantly suppressed ketamine-induced dACC pharmacoBOLD. In contrast, low-dose TS-134 led to moderate to large within and between group reductions in both BPRS positive symptoms (p = 0.02, d = -0.36; p = 0.008, d = -0.82, respectively) and dACC pharmacoBOLD (p = 0.004, d = -0.56; p = 0.079, d = -0.50, respectively) using pooled across-study placebo data. High-dose POMA exerted significant effects on clinical symptoms, but not on target engagement, suggesting a higher dose may yet be needed, while the low dose of TS-134 showed evidence of symptom reduction and target engagement. These results support further investigation of mGluR2/3 and other glutamate-targeted treatments for schizophrenia.",2020,"High-dose POMA significantly reduced ketamine-induced BPRS total symptoms within and between-groups (p < 0.01, d ","['healthy volunteers', '95 healthy volunteers']","['POMA versus placebo', 'TS-134 versus placebo', 'Two metabotropic glutamate receptor 2/3 (mGluR2/3) agonists (pomaglumetad [POMA] and TS-134', 'ketamine']","['BPRS positive symptoms', 'dACC pharmacoBOLD', 'BPRS total symptoms', 'clinical symptoms', 'ketamine-induced changes in pharmacoBOLD in the dorsal anterior cingulate cortex (dACC) and symptoms reflected on the Brief Psychiatric Rating Scale (BPRS']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C1098057', 'cui_str': 'poly(n-octyl methacrylate)'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4517565', 'cui_str': '134'}, {'cui': 'C0206529', 'cui_str': 'Metabotropic Glutamate Receptor'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}]","[{'cui': 'C0029941', 'cui_str': 'Brief psychiatric rating scale'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0175190', 'cui_str': 'Anterior Cingulate Gyrus'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0558058', 'cui_str': 'Reflecting'}]",95.0,0.504117,"High-dose POMA significantly reduced ketamine-induced BPRS total symptoms within and between-groups (p < 0.01, d ","[{'ForeName': 'Joshua T', 'Initials': 'JT', 'LastName': 'Kantrowitz', 'Affiliation': 'Columbia University, New York, NY, USA.'}, {'ForeName': 'Jack', 'Initials': 'J', 'LastName': 'Grinband', 'Affiliation': 'Columbia University, New York, NY, USA.'}, {'ForeName': 'Donald C', 'Initials': 'DC', 'LastName': 'Goff', 'Affiliation': 'Nathan Kline Institute, Orangeburg, NY, USA.'}, {'ForeName': 'Adrienne C', 'Initials': 'AC', 'LastName': 'Lahti', 'Affiliation': 'University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Stephen R', 'Initials': 'SR', 'LastName': 'Marder', 'Affiliation': 'UCLA, Los Angeles, CA, USA.'}, {'ForeName': 'Lawrence S', 'Initials': 'LS', 'LastName': 'Kegeles', 'Affiliation': 'Columbia University, New York, NY, USA.'}, {'ForeName': 'Ragy R', 'Initials': 'RR', 'LastName': 'Girgis', 'Affiliation': 'Columbia University, New York, NY, USA.'}, {'ForeName': 'Tarek', 'Initials': 'T', 'LastName': 'Sobeih', 'Affiliation': 'Nathan Kline Institute, Orangeburg, NY, USA.'}, {'ForeName': 'Melanie M', 'Initials': 'MM', 'LastName': 'Wall', 'Affiliation': 'Columbia University, New York, NY, USA.'}, {'ForeName': 'Tse-Hwei', 'Initials': 'TH', 'LastName': 'Choo', 'Affiliation': 'Columbia University, New York, NY, USA.'}, {'ForeName': 'Michael F', 'Initials': 'MF', 'LastName': 'Green', 'Affiliation': 'UCLA, Los Angeles, CA, USA.'}, {'ForeName': 'Yvonne S', 'Initials': 'YS', 'LastName': 'Yang', 'Affiliation': 'UCLA, Los Angeles, CA, USA.'}, {'ForeName': 'Junghee', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'UCLA, Los Angeles, CA, USA.'}, {'ForeName': 'Guillermo', 'Initials': 'G', 'LastName': 'Horga', 'Affiliation': 'Columbia University, New York, NY, USA.'}, {'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'Krystal', 'Affiliation': 'Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'William Z', 'Initials': 'WZ', 'LastName': 'Potter', 'Affiliation': 'National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Daniel C', 'Initials': 'DC', 'LastName': 'Javitt', 'Affiliation': 'Columbia University, New York, NY, USA.'}, {'ForeName': 'Jeffrey A', 'Initials': 'JA', 'LastName': 'Lieberman', 'Affiliation': 'Columbia University, New York, NY, USA. Jeffrey.Lieberman@nyspi.columbia.edu.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-020-0706-z'] 562,32404599,Effect of blood insulin level on postprandial hypotension in elderly people.,"OBJECTIVES The aim of the study is to discuss the effect of postprandial insulin level on blood pressure in elderly patients by comparing the blood pressure, blood glucose, and insulin levels between patients with postprandial hypotension (PPH) and non-PPH over 80 years old during fasting and within 2 h after meal, and observing the changes of parameters in patients with PPH before and after treatment with acarbose. METHODS AND MATERIALS Twenty-five PPH patients and 27 non-PPH patients were selected. The blood pressure, blood glucose, and insulin levels during fasting and within 2 h after meal were monitored. Patients with PPH were treated with acarbose. All parameters were checked one week later. RESULTS (1) Preprandial blood pressure in PPH group was significantly higher than that in non-PPH group (152.00 ± 15.62 mmHg vs. 136.40 ± 14.12 mmHg, P < 0.05). (2) The maximum decrease of postprandial systolic blood pressure (SBP) in PPH group was significantly increased compared with that of the control group (32.20 ± 13.19 mmHg vs. 9.67 ± 8.38 mmHg, P < 0.05). The maximum increases of postprandial blood glucose and insulin levels were significantly higher in PPH group than in the control group (P < 0.05). (3) After acarbose treatment, the decrease of postprandial SBP in PPH group was significantly reduced compared with that before treatment (22.67 ± 6.98 mmHg vs. 32.60 ± 9.55 mmHg, P < 0.05); the increase of postprandial blood glucose was also significantly reduced in PPH group (2.37 ± 1.63 mmol/L vs. 3.39 ± 1.62 mmol/L, P < 0.05); the increase of postprandial insulin level was reduced significantly in PPH group (12.09 ± 3.96 mU/L vs. 22.33 ± 1.78 mU/L, P < 0.05). (4) There was no correlation between the maximum decrease of postprandial SBP and the maximum increase of blood glucose (r = -0.008, P = 0.961), but the maximum decrease of postprandial SBP was positively correlated with the maximum increase of insulin (r = 0.381, P = 0.032). CONCLUSION PPH tends to occur in elderly people with elevated basal blood pressure before meal. PPH is associated with an abnormal increase of postprandial insulin secretion. Reducing the increase of postprandial insulin is one of the mechanisms of acarbose in the treatment of PPH.",2020,The maximum increases of postprandial blood glucose and insulin levels were significantly higher in PPH group than in the control group (P < 0.05).,"['elderly people with elevated basal blood pressure before meal', 'patients with postprandial hypotension (PPH) and non-PPH over 80\u2009years old during fasting and within 2\u2009h after meal, and observing the changes of parameters in patients with PPH before and after treatment with', 'Twenty-five PPH patients and 27 non-PPH patients were selected', 'Patients with PPH', 'elderly people', 'elderly patients']","['blood insulin level', 'PPH', 'postprandial insulin level', 'acarbose']","['postprandial insulin', 'postprandial hypotension', 'blood pressure', 'postprandial insulin level', 'blood glucose', 'Preprandial blood pressure', 'postprandial systolic blood pressure (SBP', 'postprandial blood glucose', 'postprandial blood glucose and insulin levels', 'postprandial SBP', 'blood pressure, blood glucose, and insulin levels', 'postprandial insulin secretion']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C1550738', 'cui_str': 'Before food'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0011744', 'cui_str': 'Deuterium'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0001758', 'cui_str': 'Aftercare'}, {'cui': 'C3715062', 'cui_str': '25'}]","[{'cui': 'C0853230', 'cui_str': 'Blood insulin'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement'}, {'cui': 'C0050393', 'cui_str': 'Acarbose'}]","[{'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C1550738', 'cui_str': 'Before food'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C1256369', 'cui_str': 'Insulin Secretion'}]",25.0,0.0150893,The maximum increases of postprandial blood glucose and insulin levels were significantly higher in PPH group than in the control group (P < 0.05).,"[{'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Hu', 'Affiliation': 'The Six Department of Cardiac Surgery, Beijing An Zhen Hospital, Capital Medical University.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Qiao', 'Affiliation': 'The Second Department of Health Care, China-Japan Friendship Hospital, Beijng, China.'}, {'ForeName': 'Xi', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'The Second Department of Health Care, China-Japan Friendship Hospital, Beijng, China.'}, {'ForeName': 'Yunyun', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'The Second Department of Health Care, China-Japan Friendship Hospital, Beijng, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'The Second Department of Health Care, China-Japan Friendship Hospital, Beijng, China.'}, {'ForeName': 'Kejing', 'Initials': 'K', 'LastName': 'Wang', 'Affiliation': 'The Second Department of Health Care, China-Japan Friendship Hospital, Beijng, China.'}, {'ForeName': 'Shuang', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': 'The Second Department of Health Care, China-Japan Friendship Hospital, Beijng, China.'}]",Blood pressure monitoring,['10.1097/MBP.0000000000000450'] 563,32198095,Effect of Transcutaneous Electrical Nerve Stimulation on the Pain Intensity During Insertion of Needle in Patients Undergoing Spinal Anesthesia: A Randomized Controlled Study.,"BACKGROUND AND OBJECTIVES Needle insertion pain during spinal anesthesia is an unpleasant experience for patients. This study aimed to investigate the effects of Transcutaneous Electrical Nerve Stimulation (TENS) on the pain intensity during the insertion of spinal needles in patients undergoing spinal anesthesia. MATERIALS AND METHODS In a double-blind clinical trial, 60 candidates for elective Trans Ureteral Lithotripsy surgery under spinal anesthesia were randomly divided into intervention and control groups. The electrodes of the TENS device were placed in the space between L3-L4 and L5-S1 vertebrae. The intensity of pain during insertion of the spinal needle by Visual Analog Scale and the frequency of attempts were recorded. RESULTS The mean age of the study samples was 34.26 ± 5.07 and 32.8 ± 5.28 in the control and intervention group, respectively. The pain intensity during insertion of spinal needles was less significant in the intervention group compared to the control group (p = 0.001). The number of attempts to insert the spinal needle between the two groups was not statistically significant (p = 0.51). The duration of spinal anesthesia implementation procedure by physician in the intervention group was significantly shorter than that of the control group (p = 0.001). CONCLUSION The use of TENS effectively reduced the pain of spinal needle insertion. Considering these beneficial effects, it is suggested that this procedure be used to relive pain in patients with spinal anesthesia.",2020,The number of attempts to insert the spinal needle between the two groups was not statistically significant (P = 0.51).,"['patients', 'The study samples were 41.66% female and 58.33% male', 'patients with spinal anesthesia', '60 candidates for elective Trans Ureteral Lithotripsy surgery under spinal anesthesia', 'Patients Undergoing Spinal anesthesia', 'patients undergoing spinal anesthesia, ImamReza hospital in Kermanshah, Iran, in 2018']","['TENS', 'Transcutaneous Electrical Nerve Stimulation (TENS']","['Pain Intensity', 'pain of spinal needle insertion', 'intensity of pain', 'pain intensity', 'duration of implementation spinal anesthesia procedure by physician', 'number of attempts to insert the spinal needle', 'pain intensity during insertion of spinal needles']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0002928', 'cui_str': 'Spinal Anesthesia'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0023878', 'cui_str': 'Litholapaxy'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0022065', 'cui_str': 'Islamic Republic of Iran'}]","[{'cui': 'C0040654', 'cui_str': 'Electric Stimulation, Transcutaneous'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0181982', 'cui_str': 'Spinal needle (physical object)'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0002928', 'cui_str': 'Spinal Anesthesia'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1881217', 'cui_str': 'Insert - unit of product usage'}]",60.0,0.0273415,The number of attempts to insert the spinal needle between the two groups was not statistically significant (P = 0.51).,"[{'ForeName': 'Javad', 'Initials': 'J', 'LastName': 'AminiSaman', 'Affiliation': 'Department of Anesthesia, School of Medicine, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}, {'ForeName': 'Hasan A', 'Initials': 'HA', 'LastName': 'Karimpour', 'Affiliation': 'Department of Anesthesia, School of Medicine, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}, {'ForeName': 'Behzad', 'Initials': 'B', 'LastName': 'Hemmatpour', 'Affiliation': 'Department of Nursing, School of Nursing, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}, {'ForeName': 'Saeed', 'Initials': 'S', 'LastName': 'Mohammadi', 'Affiliation': 'Department of Anesthesia, School of Medicine, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}, {'ForeName': 'Saeed', 'Initials': 'S', 'LastName': 'Darvishi', 'Affiliation': 'School of Allied Medical Sciences, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}, {'ForeName': 'Rasool', 'Initials': 'R', 'LastName': 'Kawyannejad', 'Affiliation': 'Department of Anesthesia, School of Allied Medical Sciences, Kermanshah University of Medical Sciences, Kermanshah, Iran; Department of Physiology, School of Medicine, Tehran University of Medical Sciences, Tehran, Iran. Electronic address: r.kaviannezhad@kums.ac.ir.'}]",Journal of acupuncture and meridian studies,['10.1016/j.jams.2020.03.062'] 564,32199123,Randomised comparison of two household survey modules for measuring stillbirths and neonatal deaths in five countries: the Every Newborn-INDEPTH study.,"BACKGROUND An estimated 5·1 million stillbirths and neonatal deaths occur annually. Household surveys, most notably the Demographic and Health Survey (DHS), run in more than 90 countries and are the main data source from the highest burden regions, but data-quality concerns remain. We aimed to compare two questionnaires: a full birth history module with additional questions on pregnancy losses (FBH+; the current DHS standard) and a full pregnancy history module (FPH), which collects information on all livebirths, stillbirths, miscarriages, and neonatal deaths. METHODS Women residing in five Health and Demographic Surveillance System sites within the INDEPTH Network (Bandim in Guinea-Bissau, Dabat in Ethiopia, IgangaMayuge in Uganda, Matlab in Bangladesh, and Kintampo in Ghana) were randomly assigned (individually) to be interviewed using either FBH+ or FPH between July 28, 2017, and Aug 13, 2018. The primary outcomes were stillbirths and neonatal deaths in the 5 years before the survey interview (measured by stillbirth rate [SBR] and neonatal mortality rate [NMR]) and mean time taken to complete the maternity history section of the questionnaire. We also assessed between-site heterogeneity. This study is registered with the Research Registry, 4720. FINDINGS 69 176 women were allocated to be interviewed by either FBH+ (n=34 805) or FPH (n=34 371). The mean time taken to complete FPH (10·5 min) was longer than for FBH+ (9·1 min; p<0·0001). Using FPH, the estimated SBR was 17·4 per 1000 total births, 21% (95% CI -10 to 62) higher than with FBH+ (15·2 per 1000 total births; p=0·20) in the 5 years preceding the survey interview. There was strong evidence of between-site heterogeneity (I 2 =80·9%; p<0·0001), with SBR higher for FPH than for FBH+ in four of five sites. The estimated NMR did not differ between modules (FPH 25·1 per 1000 livebirths vs FBH+ 25·4 per 1000 livebirths), with no evidence of between-site heterogeneity (I 2 =0·7%; p=0·40). INTERPRETATION FPH takes an average of 1·4 min longer to complete than does FBH+, but has the potential to increase reporting of stillbirths in high burden contexts. The between-site heterogeneity we found might reflect variations in interviewer training and survey implementation, emphasising the importance of interviewer skills, training, and consistent implementation in data quality. FUNDING Children's Investment Fund Foundation.",2020,"There was strong evidence of between-site heterogeneity (I 2 =80·9%; p<0·0001), with SBR higher for FPH than for FBH+ in four of five sites.","['69', '176 women', 'Women residing in five Health and Demographic Surveillance System sites within the INDEPTH Network (Bandim in Guinea-Bissau, Dabat in Ethiopia, IgangaMayuge in Uganda, Matlab in Bangladesh, and Kintampo in Ghana']","['FBH', 'full birth history module with additional questions on pregnancy losses (FBH+; the current DHS standard) and a full pregnancy history module (FPH', 'FPH', 'FBH+ or FPH']","['estimated NMR', 'mean time taken to complete FPH', 'stillbirths and neonatal deaths in the 5 years before the survey interview (measured by stillbirth rate [SBR] and neonatal mortality rate [NMR]) and mean time taken to complete the maternity history section of the questionnaire', 'SBR higher for FPH']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0733511', 'cui_str': 'Surveillance (regime/therapy)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0018387', 'cui_str': 'Portuguese Guinea'}, {'cui': 'C0015024', 'cui_str': 'Federal Democratic Republic of Ethiopia'}, {'cui': 'C0041573', 'cui_str': 'Republic of Uganda'}, {'cui': 'C0004732', 'cui_str': 'Bangladesh'}, {'cui': 'C0017516', 'cui_str': 'Republic of Ghana'}]","[{'cui': 'C0005603', 'cui_str': 'Birth History'}, {'cui': 'C3542953', 'cui_str': 'Module (core metadata concept)'}, {'cui': 'C0687675', 'cui_str': 'Pregnancy loss'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0032967', 'cui_str': 'Pregnancy History'}]","[{'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0595939', 'cui_str': 'Stillbirth'}, {'cui': 'C0410916', 'cui_str': 'Neonatal Death'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0027616', 'cui_str': 'Neonatal Mortality'}, {'cui': 'C0019665', 'cui_str': 'historical aspects'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]",69176.0,0.0722441,"There was strong evidence of between-site heterogeneity (I 2 =80·9%; p<0·0001), with SBR higher for FPH than for FBH+ in four of five sites.","[{'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Akuze', 'Affiliation': 'Maternal, Adolescent, Reproductive, and Child Health Centre, London School of Hygiene & Tropical Medicine, London, UK; Center of Excellence for Maternal Newborn and Child Health Research, School of Public Health, Makerere University, Kampala, Uganda. Electronic address: jakuze@musph.ac.ug.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Blencowe', 'Affiliation': 'Maternal, Adolescent, Reproductive, and Child Health Centre, London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Waiswa', 'Affiliation': 'Center of Excellence for Maternal Newborn and Child Health Research, School of Public Health, Makerere University, Kampala, Uganda; Department of Global Public Health, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Baschieri', 'Affiliation': 'Maternal, Adolescent, Reproductive, and Child Health Centre, London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Vladimir S', 'Initials': 'VS', 'LastName': 'Gordeev', 'Affiliation': 'Maternal, Adolescent, Reproductive, and Child Health Centre, London School of Hygiene & Tropical Medicine, London, UK; The Institute of Population Health Sciences, Queen Mary University of London, London, UK.'}, {'ForeName': 'Doris', 'Initials': 'D', 'LastName': 'Kwesiga', 'Affiliation': 'Center of Excellence for Maternal Newborn and Child Health Research, School of Public Health, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Ane B', 'Initials': 'AB', 'LastName': 'Fisker', 'Affiliation': 'Bandim Health Project, Bissau, Guinea-Bissau; Research Center for Vitamins and Vaccines, Bandim Health Project, Statens Serum Institut, Copenhagen, Denmark; Odense Patient data Explorative Network, Odense University Hospital/Institute of Clinical Research, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Sanne M', 'Initials': 'SM', 'LastName': 'Thysen', 'Affiliation': 'Bandim Health Project, Bissau, Guinea-Bissau; Research Center for Vitamins and Vaccines, Bandim Health Project, Statens Serum Institut, Copenhagen, Denmark; Center for Global Health, Department of Public Health, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Amabelia', 'Initials': 'A', 'LastName': 'Rodrigues', 'Affiliation': 'Bandim Health Project, Bissau, Guinea-Bissau.'}, {'ForeName': 'Gashaw A', 'Initials': 'GA', 'LastName': 'Biks', 'Affiliation': 'Institute of Public Health, College of Medicine and Health Sciences, University of Gondar, Gondar, Ethiopia.'}, {'ForeName': 'Solomon M', 'Initials': 'SM', 'LastName': 'Abebe', 'Affiliation': 'Institute of Public Health, College of Medicine and Health Sciences, University of Gondar, Gondar, Ethiopia.'}, {'ForeName': 'Kassahun A', 'Initials': 'KA', 'LastName': 'Gelaye', 'Affiliation': 'Institute of Public Health, College of Medicine and Health Sciences, University of Gondar, Gondar, Ethiopia.'}, {'ForeName': 'Mezgebu Y', 'Initials': 'MY', 'LastName': 'Mengistu', 'Affiliation': 'Institute of Public Health, College of Medicine and Health Sciences, University of Gondar, Gondar, Ethiopia.'}, {'ForeName': 'Bisrat M', 'Initials': 'BM', 'LastName': 'Geremew', 'Affiliation': 'Institute of Public Health, College of Medicine and Health Sciences, University of Gondar, Gondar, Ethiopia.'}, {'ForeName': 'Tadesse G', 'Initials': 'TG', 'LastName': 'Delele', 'Affiliation': 'Institute of Public Health, College of Medicine and Health Sciences, University of Gondar, Gondar, Ethiopia.'}, {'ForeName': 'Adane K', 'Initials': 'AK', 'LastName': 'Tesega', 'Affiliation': 'Institute of Public Health, College of Medicine and Health Sciences, University of Gondar, Gondar, Ethiopia.'}, {'ForeName': 'Temesgen A', 'Initials': 'TA', 'LastName': 'Yitayew', 'Affiliation': 'Institute of Public Health, College of Medicine and Health Sciences, University of Gondar, Gondar, Ethiopia.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Kasasa', 'Affiliation': 'Center of Excellence for Maternal Newborn and Child Health Research, School of Public Health, Makerere University, Kampala, Uganda; IgangaMayuge Health and Demographic Surveillance System, Iganga, Uganda.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Galiwango', 'Affiliation': 'IgangaMayuge Health and Demographic Surveillance System, Iganga, Uganda.'}, {'ForeName': 'Davis', 'Initials': 'D', 'LastName': 'Natukwatsa', 'Affiliation': 'IgangaMayuge Health and Demographic Surveillance System, Iganga, Uganda.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Kajungu', 'Affiliation': 'IgangaMayuge Health and Demographic Surveillance System, Iganga, Uganda.'}, {'ForeName': 'Yeetey Ak', 'Initials': 'YA', 'LastName': 'Enuameh', 'Affiliation': 'Kwame Nkrumah University of Science and Technology, Kumasi, Ashanti, Ghana; Kintampo Health Research Centre, Kintampo, Ghana.'}, {'ForeName': 'Obed E', 'Initials': 'OE', 'LastName': 'Nettey', 'Affiliation': 'Kintampo Health Research Centre, Kintampo, Ghana.'}, {'ForeName': 'Francis', 'Initials': 'F', 'LastName': 'Dzabeng', 'Affiliation': 'Kintampo Health Research Centre, Kintampo, Ghana.'}, {'ForeName': 'Seeba', 'Initials': 'S', 'LastName': 'Amenga-Etego', 'Affiliation': 'Kintampo Health Research Centre, Kintampo, Ghana.'}, {'ForeName': 'Sam K', 'Initials': 'SK', 'LastName': 'Newton', 'Affiliation': 'Kwame Nkrumah University of Science and Technology, Kumasi, Ashanti, Ghana; Kintampo Health Research Centre, Kintampo, Ghana.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Tawiah', 'Affiliation': 'Kintampo Health Research Centre, Kintampo, Ghana.'}, {'ForeName': 'Kwaku P', 'Initials': 'KP', 'LastName': 'Asante', 'Affiliation': 'Kintampo Health Research Centre, Kintampo, Ghana.'}, {'ForeName': 'Seth', 'Initials': 'S', 'LastName': 'Owusu-Agyei', 'Affiliation': 'Malaria Centre, London School of Hygiene & Tropical Medicine, London, UK; Kintampo Health Research Centre, Kintampo, Ghana; University of Health and Allied Sciences, Kintampo Health Research Centre, Kintampo, Ghana.'}, {'ForeName': 'Nurul', 'Initials': 'N', 'LastName': 'Alam', 'Affiliation': 'Health Systems and Population Studies Division, icddr,b, Dhaka, Bangladesh.'}, {'ForeName': 'Moinuddin M', 'Initials': 'MM', 'LastName': 'Haider', 'Affiliation': 'Health Systems and Population Studies Division, icddr,b, Dhaka, Bangladesh.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Imam', 'Affiliation': 'Health Systems and Population Studies Division, icddr,b, Dhaka, Bangladesh.'}, {'ForeName': 'Kaiser', 'Initials': 'K', 'LastName': 'Mahmud', 'Affiliation': 'Health Systems and Population Studies Division, icddr,b, Dhaka, Bangladesh.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Cousens', 'Affiliation': 'Maternal, Adolescent, Reproductive, and Child Health Centre, London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Joy E', 'Initials': 'JE', 'LastName': 'Lawn', 'Affiliation': 'Maternal, Adolescent, Reproductive, and Child Health Centre, London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Global health,['10.1016/S2214-109X(20)30044-9'] 565,32205274,"Effectiveness of Acupuncture in Dental Surgery: A Randomized, Crossover, Controlled Trial.","OBJECTIVES The objective of this crossover clinical study was to evaluate the effectiveness of Energy Regulation with Acupuncture in clinical occurrences in impacted lower third molar surgeries. METHODS The sample consisted of 22 patients with two impacted third molars, in symmetrical position; divided into two groups: Test Group (TG) with Real Energy Regulation Group and Sham Group (SG) with Acupuncture without Energy Regulation function. The extraction was performed 30 days apart. Energy flow (Ryodoraku Method) and energy regulation performed before extraction were measured. Heart Rate (HR) and Blood Pressure (BP) were evaluated before and after energy regulation and after surgery, residual edema was measured by facial measurements (angle of the mandible to tragus (A-T); angle of the mandible to labial commissure (A-LC); angle of the mandible to the wing of the nose (A-WN); angle of the mandible to the corner of the eye (A-CE); angle of the mandible to the chin (A-C); and mouth opening by the interincisal distance, before and after seven days of surgery. To quantify intraoperative bleeding (ml), blood was aspirated along with the saline solution using a portable vacuum pump adaptor. The amount of saline solution used was subtracted from the final amount of aspirated fluid. RESULTS Mean of bleeding was lower in TG (p = 0.0392). There were significant differences between groups in facial distances: A-LC (p = 0.010), A-WN (p = 0.030) and A-C (p = 0.008). CONCLUSION Energy regulation with real acupuncture was effective in reducing postoperative residual edema and intraoperative bleeding.",2020,"There were significant differences between groups in facial distances: A-LC (p=0.010), A-WN (p=0.030) and A-C (p=0.008).","['dental surgery', 'p>40,000 patient during the study period and served a population that was 16% Medicaid. Over the 3-year observation period, there were 6573 vaccination claims made collectively by the practices (4657 for obstetric patients, 1916 for gynecology patients). The most expensive component of the program was the material costs of the vaccines themselves, which ranged from a low of $9.67 for influenza vaccines, to a high of $141.40 for human papillomavirus vaccine. Staff costs for assessing and delivering vaccines during patient visits were minimal ($0.09-$1.24 per patient visit depending on the practice and whether an obstetrics or gynecology visit was being assessed) compared with staff costs for maintaining the program at a practice level (ie, assessing inventory, ordering and stocking vaccines; $0.89-$105.89 per vaccine dose given). When assessing all costs compared with all reimbursement, we found that vaccines for obstetrics patients were reimbursed at 159% of the costs over the study period, and for gynecology patients at 97% of the costs. Overall, the vaccination program was financially favorable across the practices, averaging 125% reimbursement of costs across the three study years. CONCLUSION Providing routine vaccines to patients in the ambulatory obstetrics/gynecology setting is generally not financially prohibitive for practices, and may even be financially beneficial, though there is variability between practices that can affect the overall reimbursement margin.",2020,"Overall, the vaccination program was financially favorable across the practices, averaging 125% reimbursement of costs across the three study years. ","['patients in the ambulatory obstetrics/gynecology setting', 'Outpatient Obstetrician/Gynecologist Settings', 'Collectively the 5 clinics served >40,000 patient during the study period and served a population that was 16% Medicaid', 'five obstetrics/gynecology (Ob/Gyn) practices in Colorado that had participated', 'outpatient Ob/Gyn clinics in central Colorado']","['running a vaccine program', 'multimodal intervention']","['Staff costs', 'proportion of costs', 'vaccination rates']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439841', 'cui_str': 'Ambulatory'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C0018417', 'cui_str': 'Gynecology'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0334897', 'cui_str': 'Obstetrician (occupation)'}, {'cui': 'C0237419', 'cui_str': 'Gynecologist (occupation)'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0025071', 'cui_str': 'Medicaid'}, {'cui': 'C0009399', 'cui_str': 'Colorado'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]","[{'cui': 'C0600140', 'cui_str': 'Does run (finding)'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C2700616', 'cui_str': 'Manpowers'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]",,0.0585529,"Overall, the vaccination program was financially favorable across the practices, averaging 125% reimbursement of costs across the three study years. ","[{'ForeName': 'Amanda F', 'Initials': 'AF', 'LastName': 'Dempsey', 'Affiliation': 'Department of Pediatrics, University of Colorado Denver; Adult and Child Consortium for Outcomes Research and Delivery Science, University of Colorado Denver. Electronic address: Amanda.dempsey@cuanschutz.edu.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Pyrzanowski', 'Affiliation': 'Adult and Child Consortium for Outcomes Research and Delivery Science, University of Colorado Denver.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Campbell', 'Affiliation': 'School of Pharmacy, University of Colorado Denver.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Brewer', 'Affiliation': 'Adult and Child Consortium for Outcomes Research and Delivery Science, University of Colorado Denver.'}, {'ForeName': 'Carter', 'Initials': 'C', 'LastName': 'Sevick', 'Affiliation': 'Adult and Child Consortium for Outcomes Research and Delivery Science, University of Colorado Denver.'}, {'ForeName': 'Sean T', 'Initials': 'ST', 'LastName': ""O'Leary"", 'Affiliation': 'Department of Pediatrics, University of Colorado Denver; Adult and Child Consortium for Outcomes Research and Delivery Science, University of Colorado Denver.'}]",American journal of obstetrics and gynecology,['10.1016/j.ajog.2020.02.051'] 585,31926465,"Measures of functional outcomes, work productivity, and quality of life from a randomized, phase 3 study of solriamfetol in participants with narcolepsy.","OBJECTIVE Solriamfetol (formerly JZP-110), a dopamine/norepinephrine reuptake inhibitor, is approved in the US to improve wakefulness in adults with excessive daytime sleepiness associated with narcolepsy (75-150 mg/d) or obstructive sleep apnea (37.5-150 mg/d). In a randomized, double-blind, placebo-controlled trial in participants with narcolepsy, effects of solriamfetol on functional status, health-related quality of life (HRQoL), and work productivity were evaluated. METHODS Participants with narcolepsy (N = 239) were randomized to solriamfetol 75, 150, or 300 mg, or placebo for 12 weeks. Outcome measures included the Functional Outcomes of Sleep Questionnaire short version (FOSQ-10), 36-Item Short Form Health Survey version 2 (SF-36v2), and Work Productivity and Activity Impairment questionnaire for Specific Health Problem (WPAI:SHP). A mixed-effects model with repeated measures was used for comparisons vs placebo. RESULTS At week 12, solriamfetol increased FOSQ-10 total score, with greatest mean difference from placebo (95% CI) at 300 mg (1.45 [0.31, 2.59]). On SF-36v2, improvements vs placebo were observed in physical component summary scores (300 mg: 2.22 [0.04, 4.41]) and subscales of role physical, general health, and vitality. On WPAI:SHP, solriamfetol 150 mg reduced overall work impairment vs placebo (-15.5 [-29.52, -1.47]), and 150 and 300 mg reduced activity impairment vs placebo (-10.05 [-19.48, -0.62] and -13.49 [-23.19, -3.78], respectively). Most treatment-emergent adverse events (TEAEs) were mild or moderate in severity. Common TEAEs were headache, nausea, decreased appetite, nasopharyngitis, dry mouth, and anxiety. CONCLUSIONS Solriamfetol improved measures of functional status, HRQoL, and work productivity, particularly at the 150- and 300-mg doses. Most TEAEs were mild to moderate. TRIAL REGISTRATION ClinicalTrials.gov identifier NCT02348593, EudraCT number 2014-005487-15.",2020,"At week 12, solriamfetol increased FOSQ-10 total score, with greatest mean difference from placebo (95% CI) at 300 mg (1.45 [0.31, 2.59]).","['participants with narcolepsy', 'adults with excessive daytime sleepiness associated with narcolepsy (75-150\xa0mg/d) or obstructive sleep apnea (37.5-150\xa0mg/d', 'Participants with narcolepsy (N\xa0=\xa0239']","['placebo', 'solriamfetol']","['headache, nausea, decreased appetite, nasopharyngitis, dry mouth, and anxiety', 'FOSQ-10 total score', 'activity impairment', 'Functional Outcomes of Sleep Questionnaire short version (FOSQ-10), 36-Item Short Form Health Survey version 2 (SF-36v2), and Work Productivity and Activity Impairment questionnaire for Specific Health Problem (WPAI:SHP', 'overall work impairment', 'functional outcomes, work productivity, and quality of life', 'subscales of role physical, general health, and vitality', 'functional status, health-related quality of life (HRQoL), and work productivity', 'functional status, HRQoL, and work productivity', 'physical component summary scores']","[{'cui': 'C0027404', 'cui_str': 'Narcoleptic Syndrome'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4551761', 'cui_str': 'Excessive daytime sleepiness'}, {'cui': 'C0332281', 'cui_str': 'Associated with (attribute)'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0520679', 'cui_str': 'Syndrome, Sleep Apnea, Obstructive'}, {'cui': 'C4517742', 'cui_str': '37.5 (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0232462', 'cui_str': 'Decrease in appetite (finding)'}, {'cui': 'C0027441', 'cui_str': 'Nasopharyngitis'}, {'cui': 'C0043352', 'cui_str': 'Mouth Dryness'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0033269', 'cui_str': 'Productivity'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0034380'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}]",,0.392093,"At week 12, solriamfetol increased FOSQ-10 total score, with greatest mean difference from placebo (95% CI) at 300 mg (1.45 [0.31, 2.59]).","[{'ForeName': 'Helene A', 'Initials': 'HA', 'LastName': 'Emsellem', 'Affiliation': 'The Center for Sleep & Wake Disorders, Chevy Chase, MD, USA; George Washington University Medical Center, Washington, DC, USA. Electronic address: sleepdoc@sleepdoc.com.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Thorpy', 'Affiliation': 'Montefiore Medical Center, Bronx, NY, USA.'}, {'ForeName': 'Gert Jan', 'Initials': 'GJ', 'LastName': 'Lammers', 'Affiliation': 'Department of Neurology, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Colin M', 'Initials': 'CM', 'LastName': 'Shapiro', 'Affiliation': 'University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Geert', 'Initials': 'G', 'LastName': 'Mayer', 'Affiliation': 'Hephata Klinik, Schwalmstadt, Germany; Philipps University Marburg, Marburg, Germany.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Plazzi', 'Affiliation': 'Department of Biomedical and Neuromotor Sciences, University of Bologna, Bologna, Italy.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Chen', 'Affiliation': 'Jazz Pharmaceuticals, Palo Alto, CA, USA.'}, {'ForeName': 'Lawrence P', 'Initials': 'LP', 'LastName': 'Carter', 'Affiliation': 'Jazz Pharmaceuticals, Palo Alto, CA, USA; University of Arkansas for Medical Sciences, Little Rock, AR, USA.'}, {'ForeName': 'Kathleen F', 'Initials': 'KF', 'LastName': 'Villa', 'Affiliation': 'Jazz Pharmaceuticals, Palo Alto, CA, USA.'}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Lee', 'Affiliation': 'Jazz Pharmaceuticals, Palo Alto, CA, USA.'}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Menno', 'Affiliation': 'Jazz Pharmaceuticals, Philadelphia, PA, USA.'}, {'ForeName': 'Jed', 'Initials': 'J', 'LastName': 'Black', 'Affiliation': 'Jazz Pharmaceuticals, Palo Alto, CA, USA; Stanford Center for Sleep Sciences and Medicine, Palo Alto, CA, USA.'}, {'ForeName': 'Yves', 'Initials': 'Y', 'LastName': 'Dauvilliers', 'Affiliation': 'Gui-de-Chauliac Hospital, CHU Montpellier, INSERM U1061, France.'}]",Sleep medicine,['10.1016/j.sleep.2019.11.1250'] 586,31095683,Cost-effectiveness of Hepatitis C Virus Treatment Models for People Who Inject Drugs in Opioid Agonist Treatment Programs.,"BACKGROUND Many people who inject drugs in the United States have chronic hepatitis C virus (HCV). On-site treatment in opiate agonist treatment (OAT) programs addresses HCV treatment barriers, but few evidence-based models exist. METHODS We evaluated the cost-effectiveness of HCV treatment models for OAT patients using data from a randomized trial conducted in Bronx, New York. We used a decision analytic model to compare self-administered individual treatment (SIT), group treatment (GT), directly observed therapy (DOT), and no intervention for a simulated cohort with the same demographic characteristics of trial participants. We projected long-term outcomes using an established model of HCV disease progression and treatment (hepatitis C cost-effectiveness model: HEP-CE). Incremental cost-effectiveness ratios (ICERs) are reported in 2016 US$/quality-adjusted life years (QALY), discounted 3% annually, from the healthcare sector and societal perspectives. RESULTS For those assigned to SIT, we projected 89% would ever achieve a sustained viral response (SVR), with 7.21 QALYs and a $245 500 lifetime cost, compared to 22% achieving SVR, with 5.49 QALYs and a $161 300 lifetime cost, with no intervention. GT was more efficient than SIT, resulting in 0.33 additional QALYs and a $14 100 lower lifetime cost per person, with an ICER of $34 300/QALY, compared to no intervention. DOT was slightly more effective and costly than GT, with an ICER > $100 000/QALY, compared to GT. In probabilistic sensitivity analyses, GT and DOT were preferred in 91% of simulations at a threshold of <$100 000/QALY; conclusions were similar from the societal perspective. CONCLUSIONS All models were associated with high rates of achieving SVR, compared to standard care. GT and DOT treatment models should be considered as cost-effective alternatives to SIT.",2020,"In probabilistic sensitivity analyses GT and DOT were preferred in 91% of simulations at a threshold of <$100,000/QALY; conclusions were similar from the societal perspective. ","['People', 'OAT patients using data from a randomized trial conducted in Bronx, NY']","['HCV', 'self-administered individual treatment (SIT), group treatment (GT), directly observed therapy (DOT), and no intervention']","['sustained viral response (SVR), 7.21 QALYs, and $245,500 lifetime cost', 'Incremental cost-effectiveness ratios (ICERs', 'cost-effectiveness']","[{'cui': 'C0028753', 'cui_str': 'Oats (substance)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0872145', 'cui_str': 'Directly Observed Therapy'}]","[{'cui': 'C3888663', 'cui_str': 'Sustained viral response'}, {'cui': 'C0080071', 'cui_str': 'QALY'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",89.0,0.0291665,"In probabilistic sensitivity analyses GT and DOT were preferred in 91% of simulations at a threshold of <$100,000/QALY; conclusions were similar from the societal perspective. ","[{'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Gutkind', 'Affiliation': 'Department of Healthcare Policy & Research, Weill Cornell Medical College, New York.'}, {'ForeName': 'Bruce R', 'Initials': 'BR', 'LastName': 'Schackman', 'Affiliation': 'Department of Healthcare Policy & Research, Weill Cornell Medical College, New York.'}, {'ForeName': 'Jake R', 'Initials': 'JR', 'LastName': 'Morgan', 'Affiliation': 'Department of Medicine, Section of Infectious Diseases, Boston Medical Center, Massachusetts.'}, {'ForeName': 'Jared A', 'Initials': 'JA', 'LastName': 'Leff', 'Affiliation': 'Department of Healthcare Policy & Research, Weill Cornell Medical College, New York.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Agyemang', 'Affiliation': 'Department of Medicine, Albert Einstein College of Medicine, Montefiore Medical Center, Bronx, New York.'}, {'ForeName': 'Sean M', 'Initials': 'SM', 'LastName': 'Murphy', 'Affiliation': 'Department of Healthcare Policy & Research, Weill Cornell Medical College, New York.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Akiyama', 'Affiliation': 'Department of Medicine, Albert Einstein College of Medicine, Montefiore Medical Center, Bronx, New York.'}, {'ForeName': 'Brianna L', 'Initials': 'BL', 'LastName': 'Norton', 'Affiliation': 'Department of Medicine, Albert Einstein College of Medicine, Montefiore Medical Center, Bronx, New York.'}, {'ForeName': 'Alain H', 'Initials': 'AH', 'LastName': 'Litwin', 'Affiliation': 'Department of Medicine, University of South Carolina School of Medicine and Greenville Health System.'}, {'ForeName': 'Benjamin P', 'Initials': 'BP', 'LastName': 'Linas', 'Affiliation': 'Department of Medicine, Section of Infectious Diseases, Boston Medical Center, Massachusetts.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciz384'] 587,32007230,Ticagrelor versus clopidogrel in patients undergoing implantation of paclitaxel-eluting stent in the femoropopliteal district: A randomized pilot study using frequency-domain optical coherence tomography.,"OBJECTIVES Aim of this study was to evaluate different response in platelet reactivity and vessel healing using high-resolution frequency-domain optical coherence tomography (FD-OCT) in patients with femoropopliteal artery disease treated with ZILVER PTX drug eluting stents (DES), and randomly assigned to clopidogrel or ticagrelor for 12 months. BACKGROUND The optimal antithrombotic regimen for long-term management of patients with peripheral artery disease (PAD) after revascularization is poorly defined and often extrapolated from trials performed on patients undergoing percutaneous coronary intervention. METHODS In this single center randomized trial 40 patients with femoropopliteal artery disease treated with ZILVER PTX DES stents, were randomized to Ticagrelor (T) + Aspirin for 3 months, subsequently continuing Ticagrelor alone for another 9 months or Clopidogrel (C) + Aspirin for 3 months, subsequently continuing Clopidogrel alone for 9 months. Platelet reactivity via the P2Y12 pathway was evaluated at baseline and at 3 months follow-up, angiographic and FD-OCT follow-up along the entire stented segment was performed at 12 months. RESULTS No significant difference between T and C group was found concerning net percentage volume obstruction (29.7% ± 17.6% vs. 31.2% ± 10.7%; p = 0.78). FD-OCT at 12 months showed a high percentage of uncovered stent struts in both groups: 24.2% ± 32.8% in the T group vs 15.3% ± 15.8% in the C group (p = 0.4). Mean values of platelet reactivity units (PRU) at 3 month follow-up were 81 ± 72 in the T group and 200 ± 61 in the C group (p < 0.001). CONCLUSIONS Significantly higher platelet reactivity remains in patients treated with clopidogrel as compared to ticagrelor 3 months after PTA and stent implantation. Ticagrelor does not reduce neointimal proliferation in patients treated with DES in the femoropopliteal district as compared with clopidogrel. A large amount of uncovered stent struts at 12-month follow-up was found in these patients regardless of the antiplatelet treatment assumed.",2020,Significantly higher platelet reactivity remains in patients treated with clopidogrel as compared to ticagrelor 3 months after PTA and stent implantation.,"['patients with peripheral artery disease (PAD', 'patients with femoropopliteal artery disease treated with ZILVER PTX drug eluting stents (DES', 'patients undergoing implantation of paclitaxel-eluting stent in the femoropopliteal district', '40 patients with femoropopliteal artery disease treated with', 'patients undergoing percutaneous coronary intervention']","['high-resolution frequency-domain optical coherence tomography (FD-OCT', 'Ticagrelor (T)\xa0+\xa0Aspirin', 'ZILVER PTX DES stents', 'clopidogrel', 'Ticagrelor alone for another 9\xa0months or Clopidogrel (C)\xa0+\xa0Aspirin', 'Ticagrelor', 'clopidogrel or ticagrelor', 'frequency-domain optical coherence tomography']","['platelet reactivity', 'Mean values of platelet reactivity units (PRU', 'FD-OCT', 'Platelet reactivity', 'neointimal proliferation', 'net percentage volume obstruction', 'high percentage of uncovered stent struts']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1704436', 'cui_str': 'Peripheral Artery Disease'}, {'cui': 'C0441601', 'cui_str': 'Padding (qualifier value)'}, {'cui': 'C0003842', 'cui_str': 'Arteries'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0038257', 'cui_str': 'Stents'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0920367', 'cui_str': 'Tomography, Optical Coherence'}, {'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}, {'cui': 'C0038257', 'cui_str': 'Stents'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C0005821', 'cui_str': 'Platelets'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0334094', 'cui_str': 'Proliferation (morphologic abnormality)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0038257', 'cui_str': 'Stents'}, {'cui': 'C0441295', 'cui_str': 'Strut (physical object)'}]",40.0,0.066015,Significantly higher platelet reactivity remains in patients treated with clopidogrel as compared to ticagrelor 3 months after PTA and stent implantation.,"[{'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Ducci', 'Affiliation': 'Cardio-Neuro-Vascular Department, Ospedale S. Donato, Arezzo, Italy. Electronic address: kducci@gmail.com.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Liistro', 'Affiliation': 'Cardio-Neuro-Vascular Department, Ospedale S. Donato, Arezzo, Italy.'}, {'ForeName': 'Italo', 'Initials': 'I', 'LastName': 'Porto', 'Affiliation': 'Cardio-Thoraco-Vascular Department, Ospedale Policlinico San Martino IRCCS, Genova, Italy; Cardiovascular Disease Unit, Università di Genova, Genova, Italy.'}, {'ForeName': 'Giorgio', 'Initials': 'G', 'LastName': 'Ventoruzzo', 'Affiliation': 'Cardio-Neuro-Vascular Department, Ospedale S. Donato, Arezzo, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Angioli', 'Affiliation': 'Cardio-Neuro-Vascular Department, Ospedale S. Donato, Arezzo, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Falsini', 'Affiliation': 'Cardio-Neuro-Vascular Department, Ospedale S. Donato, Arezzo, Italy.'}, {'ForeName': 'Rocco', 'Initials': 'R', 'LastName': 'Vergallo', 'Affiliation': 'Department of Cardiology, Fondazione Policlinico Universitario A. Gemelli, IRCCS, Rome, Italy.'}, {'ForeName': 'Leonardo', 'Initials': 'L', 'LastName': 'Bolognese', 'Affiliation': 'Cardio-Neuro-Vascular Department, Ospedale S. Donato, Arezzo, Italy.'}]",International journal of cardiology,['10.1016/j.ijcard.2020.01.024'] 588,31701566,Monetary reinforcement for self-monitoring of blood glucose among young people with type 1 diabetes: evaluating effects on psychosocial functioning.,"AIMS To explore the auxiliary psychosocial effects of a monetary reinforcement intervention targeting self-monitoring of blood glucose among young people with Type 1 diabetes. METHODS Sixty young people with Type 1 diabetes, HbA 1c concentrations between 58 and 119 mmol/mol (7.5-13.0%), and average self-monitoring of blood glucose <4 times per day were randomized to either enhanced usual care or a 24-week intervention of monetary rewards for self-monitoring of blood glucose and associated behaviours (e.g. uploading glucose meters). Data were collected from the young people and their parents at baseline, during the intervention (6, 12 and 24 weeks) and after the intervention (36 weeks). RESULTS Linear mixed models were used to evaluate the intervention effects on psychosocial outcomes, adjusting for corresponding baseline levels and potential moderation by baseline level. The intervention reduced diabetes distress at week 6 among young people who had average and high baseline distress. It also reduced diabetes distress at weeks 12 and 24 among those with low baseline distress. The intervention also reduced young person-reported diabetes-related family conflict and diabetes-related interference among those with high baseline scores in these areas; however, the intervention worsened young person-reported diabetes interference among those with low baseline interference. Effects were medium-sized and time-limited. CONCLUSIONS Findings indicate predominantly positive impacts of monetary reinforcement interventions on psychosocial outcomes, although effects varied by outcome and time point. Whereas early improvements in diabetes distress were observed for all who received the intervention, improvements in other areas varied according to the level of psychosocial challenge at baseline. Incorporating psychosocial interventions may bolster and maintain effects over time.",2020,"The intervention also reduced young person-reported diabetes-related family conflict and diabetes-related interference among those with high baseline scores in these areas; however, the intervention worsened young person-reported diabetes interference among those with low baseline interference.","['young people with type 1 diabetes', 'young people with Type 1 diabetes', 'Sixty young people with Type 1 diabetes, HbA 1c concentrations between 58 and 119 mmol/mol (7.5-13.0%), and average self-monitoring of blood glucose <4 times per day']","['monetary reinforcement intervention targeting self-monitoring', 'enhanced usual care or a 24-week intervention of monetary rewards for self-monitoring of blood glucose and associated behaviours (e.g. uploading glucose meters']","['diabetes distress', 'psychosocial outcomes', 'blood glucose']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mole - unit'}, {'cui': 'C4517859', 'cui_str': 'Seven point five'}, {'cui': 'C0005803', 'cui_str': 'Monitoring, Home Blood Glucose'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0439505', 'cui_str': 'per day'}]","[{'cui': 'C0035007', 'cui_str': 'Reinforcement'}, {'cui': 'C0588436', 'cui_str': 'Self-monitoring (regime/therapy)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0035397', 'cui_str': 'Rewards'}, {'cui': 'C0005803', 'cui_str': 'Monitoring, Home Blood Glucose'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0475209', 'cui_str': 'm'}]","[{'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}]",60.0,0.0182264,"The intervention also reduced young person-reported diabetes-related family conflict and diabetes-related interference among those with high baseline scores in these areas; however, the intervention worsened young person-reported diabetes interference among those with low baseline interference.","[{'ForeName': 'J J', 'Initials': 'JJ', 'LastName': 'Wong', 'Affiliation': 'Department of Pediatrics, Stanford University, Palo Alto, CA, USA.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Addala', 'Affiliation': 'Department of Pediatrics, Stanford University, Palo Alto, CA, USA.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Naranjo', 'Affiliation': 'Department of Pediatrics, Stanford University, Palo Alto, CA, USA.'}, {'ForeName': 'K K', 'Initials': 'KK', 'LastName': 'Hood', 'Affiliation': 'Department of Pediatrics, Stanford University, Palo Alto, CA, USA.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Cengiz', 'Affiliation': 'Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'M K', 'Initials': 'MK', 'LastName': 'Ginley', 'Affiliation': 'East Tennessee State University, Johnson City, TN, USA.'}, {'ForeName': 'R S', 'Initials': 'RS', 'LastName': 'Feinn', 'Affiliation': 'Quinnipiac University, Hamden, CT, USA.'}, {'ForeName': 'J A', 'Initials': 'JA', 'LastName': 'Wagner', 'Affiliation': 'School of Dental Medicine and School of Medicine, University of Connecticut, Storrs, CT, USA.'}]",Diabetic medicine : a journal of the British Diabetic Association,['10.1111/dme.14174'] 589,31171589,Use of a Medical-Alert Accessory in CKD: A Pilot Study.,"BACKGROUND AND OBJECTIVES Poor disease recognition may jeopardize the safety of CKD care. We examined safety events and outcomes in patients with CKD piloting a medical-alert accessory intended to improve disease recognition and an observational subcohort from the same population. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS We recruited 350 patients with stage 2-5 predialysis CKD. The first (pilot) 108 participants were given a medical-alert accessory (bracelet or necklace) indicating the diagnosis of CKD and displaying a website with safe CKD practices. The subsequent (observation) subcohort ( n =242) received usual care. All participants underwent annual visits with ascertainment of patient-reported events (class 1) and actionable safety findings (class 2). Secondary outcomes included 50% GFR reduction, ESKD, and death. Cox proportional hazards assessed the association of the medical-alert accessory with outcomes. RESULTS Median follow-up of pilot and observation subcohorts were 52 (interquartile range, 44-63) and 37 (interquartile range, 27-47) months, respectively. The frequency of class 1 and class 2 safety events reported at annual visits was not different in the pilot versus observation group, with 108.7 and 100.6 events per 100 patient-visits ( P =0.13), and 38.3 events and 41.2 events per 100 patient visits ( P =0.23), respectively. The medical-alert accessory was associated with lower crude and adjusted rate of ESKD versus the observation group (hazard ratio, 0.42; 95% confidence interval, 0.20 to 0.89; and hazard ratio, 0.38; 95% confidence interval, 0.16 to 0.94, respectively). The association of the medical-alert accessory with the composite endpoint of ESKD or 50% reduction GFR was variable over time but appeared to have an early benefit (up to 23 months) with its use. There was no significant difference in incidence of hospitalization, death, or a composite of all outcomes between medical-alert accessory users and the observational group. CONCLUSIONS The medical-alert accessory was not associated with incidence of safety events but was associated with a lower rate of ESKD relative to usual care.",2019,"The frequency of class 1 and class 2 safety events reported at annual visits was not different in the pilot versus observation group, with 108.7 and 100.6 events per 100 patient-visits ( P =0.13), and 38.3 events and 41.2 events per 100 patient visits ( P =0.23), respectively.","['All participants underwent annual visits with ascertainment of patient-reported events (class 1) and actionable safety findings (class 2', '108 participants were given a medical-alert accessory (bracelet or necklace) indicating the diagnosis of CKD and displaying a website with safe CKD practices', 'patients with CKD piloting a medical-alert accessory intended to improve disease recognition and an observational subcohort from the same population', '350 patients with stage 2-5 predialysis CKD']",['usual care'],"['50% GFR reduction, ESKD, and death', 'incidence of hospitalization, death, or a composite of all outcomes', 'frequency of class 1 and class 2 safety events']","[{'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0441885', 'cui_str': 'Class 1 (qualifier value)'}, {'cui': 'C0581560', 'cui_str': 'Safety finding'}, {'cui': 'C0441886', 'cui_str': 'Class 2 (qualifier value)'}, {'cui': 'C4517530', 'cui_str': 'One hundred and eight'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0473169', 'cui_str': 'Aviators'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0524637', 'cui_str': 'Recognition (Psychology)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C4517735', 'cui_str': '350'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2 (qualifier value)'}]",[],"[{'cui': 'C0017654', 'cui_str': 'Glomerular Filtration Rate'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0441885', 'cui_str': 'Class 1 (qualifier value)'}, {'cui': 'C0441886', 'cui_str': 'Class 2 (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}]",350.0,0.03423,"The frequency of class 1 and class 2 safety events reported at annual visits was not different in the pilot versus observation group, with 108.7 and 100.6 events per 100 patient-visits ( P =0.13), and 38.3 events and 41.2 events per 100 patient visits ( P =0.23), respectively.","[{'ForeName': 'Eli', 'Initials': 'E', 'LastName': 'Farhy', 'Affiliation': 'Departments of Medicine and.'}, {'ForeName': 'Clarissa Jonas', 'Initials': 'CJ', 'LastName': 'Diamantidis', 'Affiliation': 'Divisions of General Internal Medicine and.'}, {'ForeName': 'Rebecca M', 'Initials': 'RM', 'LastName': 'Doerfler', 'Affiliation': 'Departments of Medicine and.'}, {'ForeName': 'Wanda J', 'Initials': 'WJ', 'LastName': 'Fink', 'Affiliation': 'Departments of Medicine and.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Zhan', 'Affiliation': 'Epidemiology and Public Health, University of Maryland School of Medicine, Baltimore, Maryland; and.'}, {'ForeName': 'Jeffrey C', 'Initials': 'JC', 'LastName': 'Fink', 'Affiliation': 'Departments of Medicine and jfink@som.umaryland.edu.'}]",Clinical journal of the American Society of Nephrology : CJASN,['10.2215/CJN.13531118'] 590,29681188,"Improvement in clinical outcomes after dry needling versus myofascial release on pain pressure thresholds, quality of life, fatigue, pain intensity, quality of sleep, anxiety, and depression in patients with fibromyalgia syndrome.","Purpose: To compare the effectiveness of dry needling versus myofascial release on myofascial trigger points pain in cervical muscles, quality of life, impact of symptoms pain, quality of sleep, anxiety, depression, and fatigue in patients with fibromyalgia syndrome. Method: A single-blind randomized controlled trial was conducted. Sixty-four subjects with fibromyalgia were randomly assigned to a dry needling group or a myofascial release group. Pain pressure thresholds of myofascial trigger points were evaluated in the cervical muscles. In addition, quality of life, impact of fibromyalgia symptoms, quality of sleep, intensity of pain, anxiety and depression symptoms, impact of fatigue at baseline and post treatment after four weeks of intervention were evaluated. Results: Significant improvement was found in most pain pressure thresholds of the myofascial trigger points in cervical muscles in the dry needling group compared to myofascial release ( p  < 0.05). Similarly, these differences between groups were found for the components of quality of life of physical function ( F  = 12.74, p  = 0.001), physical role ( F  = 11.24, p  = 0.001), body pain ( F  =30.26, p  < 0.001), general health ( F  = 15.83, p  < 0.001), vitality ( F  = 13.51, p  = 0.001), social function ( F  = 4.73, p  = 0.034), emotional role ( F  = 8.01, p  = 0.006), and mental health ( F  = 4.95, p  = 0.030). Similar results were achieved for total impact of FMS symptoms ( F  = 42.91, p  < 0.001), quality of sleep ( F  = 11.96, p  = 0.001), state anxiety ( F  = 7.40, p  = 0.009), and trait anxiety ( F  = -14.63, p  < 0.001), hospital anxiety and depression ( F  = 20.60, p  < 0.001), general pain intensity ( F  = 29.59, p  < 0.001), and fatigue ( F  = -25.73, p  < 0.001). Conclusion: The dry needling therapy showed higher improvements in comparison with myofascial release therapy for pain pressure thresholds, the components of quality of life of physical role, body pain, vitality and social function, as well as the total impact of FMS symptoms, quality of sleep, state and trait anxiety, hospital anxiety-depression, general pain intensity and fatigue. Implications for rehabilitation Dry needling therapy reduces myofascial trigger point pain in the short term in patients with fibromyalgia syndrome. This therapeutic approach improves anxiety, depression, fatigue symptoms, quality of life, and sleep after treatment. Dry needling and myofascial release therapies decrease intensity of pain, and the impact of fibromyalgia symptoms in this population. These intervention approaches should be considered in an independent manner as complementary therapies within a multidisciplinary setting.",2019,Significant improvement was found in most pain pressure thresholds of the myofascial trigger points in cervical muscles in the dry needling group compared to myofascial release ( p  < 0.05).,"['Sixty-four subjects with fibromyalgia', 'patients with fibromyalgia syndrome']","['rehabilitation Dry needling therapy', 'dry needling versus myofascial release', 'Dry needling and myofascial release therapies', 'dry needling group or a myofascial release group', 'dry needling therapy']","['trait anxiety', 'quality of life, impact of fibromyalgia symptoms, quality of sleep, intensity of pain, anxiety and depression symptoms, impact of fatigue', 'Pain pressure thresholds of myofascial trigger points', 'quality of life of physical function', 'vitality', 'quality of life, impact of symptoms pain, quality of sleep, anxiety, depression, and fatigue', 'emotional role', 'fatigue', 'myofascial release', 'mental health', 'pain pressure thresholds of the myofascial trigger points in cervical muscles', 'quality of life of physical role, body pain, vitality and social function, as well as the total impact of FMS symptoms, quality of sleep, state and trait anxiety, hospital anxiety-depression, general pain intensity and fatigue', 'quality of sleep', 'anxiety, depression, fatigue symptoms, quality of life, and sleep', 'general pain intensity', 'social function', 'total impact of FMS symptoms', 'general health', 'state anxiety', 'myofascial trigger point pain', 'pain pressure thresholds, quality of life, fatigue, pain intensity, quality of sleep, anxiety, and depression', 'body pain', 'physical role', 'hospital anxiety and depression']","[{'cui': 'C4517839', 'cui_str': '64'}, {'cui': 'C0016053', 'cui_str': 'Fibrositis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0394648', 'cui_str': 'Dry needle acupuncture (procedure)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0695600', 'cui_str': 'Myofascial release (regime/therapy)'}, {'cui': 'C0205222', 'cui_str': 'Dry (qualifier value)'}, {'cui': 'C0398296', 'cui_str': 'Cannulation of vascular fistula, graft or prosthetic device (procedure)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0034380'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0016053', 'cui_str': 'Fibrositis'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep (observable entity)'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0449864', 'cui_str': 'Threshold (property) (qualifier value)'}, {'cui': 'C0458343', 'cui_str': 'Trigger point (body structure)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0695600', 'cui_str': 'Myofascial release (regime/therapy)'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0205064', 'cui_str': 'Cervical (qualifier value)'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0338908', 'cui_str': 'Mixed anxiety and depressive disorder (disorder)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0439053', 'cui_str': 'Fatigue - symptom (finding)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C3179196', 'cui_str': 'Myofascial Trigger Point Pain'}]",64.0,0.0834586,Significant improvement was found in most pain pressure thresholds of the myofascial trigger points in cervical muscles in the dry needling group compared to myofascial release ( p  < 0.05).,"[{'ForeName': 'Adelaida M', 'Initials': 'AM', 'LastName': 'Castro Sánchez', 'Affiliation': 'a Department of Nursing, Physical Therapy and Medicine , University of Almeria (UAL) , Almeria , Spain.'}, {'ForeName': 'Hector', 'Initials': 'H', 'LastName': 'García López', 'Affiliation': 'b Department of Physical Therapy , Andalusian Health Service, Primary Health Physical Therapy , Almeria , Spain.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Fernández Sánchez', 'Affiliation': 'a Department of Nursing, Physical Therapy and Medicine , University of Almeria (UAL) , Almeria , Spain.'}, {'ForeName': 'José Manuel', 'Initials': 'JM', 'LastName': 'Pérez Mármol', 'Affiliation': 'c Research Institute - Biosanitaria Granada (IBS - Granada), Department of Physical Therapy, Faculty of Health Science , University of Granada (UGR) , Granada , Spain.'}, {'ForeName': 'María Encarnación', 'Initials': 'ME', 'LastName': 'Aguilar-Ferrándiz', 'Affiliation': 'c Research Institute - Biosanitaria Granada (IBS - Granada), Department of Physical Therapy, Faculty of Health Science , University of Granada (UGR) , Granada , Spain.'}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Luque Suárez', 'Affiliation': 'd Department of Physical Therapy, Faculty of Health Sciences , University of Malaga (UMA) , Malaga , Spain.'}, {'ForeName': 'Guillermo Adolfo', 'Initials': 'GA', 'LastName': 'Matarán Peñarrocha', 'Affiliation': 'e Malaga Health District , Andalusian Health Service, Primary Health Medical , Malaga , Spain.'}]",Disability and rehabilitation,['10.1080/09638288.2018.1461259'] 591,32167784,Primary Care Management of Children with Attention-Deficit/Hyperactivity Disorder Appears More Assertive Following Brief Psychiatric Intervention Compared with Single Session Consultation.,"Objectives: We examined primary care providers' (PCPs') management of attention-deficit/hyperactivity disorder (ADHD) during and following families' participation in two arms of the Children's ADHD Telemental Health Treatment Study. We hypothesized that more intensive treatment during the trial would show an ""after-effect"" with more assertive PCPs' management during short term follow-up. Methods: We conducted a pragmatic follow-up of PCPs' management of children with ADHD who had been randomized to two service delivery models. In the Direct Service Model, psychiatrists provided six sessions over 22 weeks of pharmacotherapy followed by behavior training. In the Consultation Model, psychiatrists provided a single-session consultation and made treatment recommendations to PCPs who implemented these recommendations at their discretion for 22 weeks. At the end of the trial, referring PCPs for both service delivery models resumed ADHD treatment for 10 weeks. We performed intent-to-treat analysis using all 223 original participants. We applied linear regression models on continuous outcomes, Poisson regression models on count outcomes, and logistic regression models to binary outcomes. Missing data were addressed through imputations. Results: Participants in the Direct Service Model had more ADHD visits than those in the Consultation Model across the full 32 weeks (mean = 7.05 visits vs. 3.36 visits; adjusted rate ratio = 2.1 [1.85-2.38]; p  < 0.0001). During follow-up, participants in the DSM were more likely to be taking ADHD-related medications (82% vs. 61%; adjusted odds ratio = 2.44 [1.24-4.81], p  = 0.01). At 32 weeks, participants in the Direct Service Model had higher stimulant dosages (adjusted difference = 5.64 [0.12-11.15] mg; p  = 0.046). Conclusion: These results from a pragmatic follow-up of a randomized trial suggest an ""after-effect"" for brief intensive treatment in the Direct Service Model on the short term follow-up management of ADHD in primary care.",2020,had more ADHD visits than those in the Consultation Model across the full 32 weeks,"['223 original participants', 'children with ADHD who had been randomized to two service delivery models', 'Results: Participants in the Direct Service Model', 'Children with Attention-Deficit/Hyperactivity Disorder']","['Psychiatric Intervention', ""primary care providers' (PCPs') management of attention-deficit/hyperactivity disorder (ADHD""]",['ADHD visits'],"[{'cui': 'C0205313', 'cui_str': 'Original (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}]","[{'cui': 'C0205487', 'cui_str': 'Psychiatric (qualifier value)'}, {'cui': 'C2735026', 'cui_str': 'Primary care provider (occupation)'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}]","[{'cui': 'C1263846', 'cui_str': 'ADDH'}]",,0.0557932,had more ADHD visits than those in the Consultation Model across the full 32 weeks,"[{'ForeName': 'Carol M', 'Initials': 'CM', 'LastName': 'Rockhill', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Washington School of Medicine, Seattle, Washington, USA.'}, {'ForeName': 'L Lee', 'Initials': 'LL', 'LastName': 'Carlisle', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Washington School of Medicine, Seattle, Washington, USA.'}, {'ForeName': 'Pingping', 'Initials': 'P', 'LastName': 'Qu', 'Affiliation': ""Center for Child Health, Behavior and Development, Seattle Children's Research Institute, Seattle, Washington, USA.""}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Vander Stoep', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Washington School of Medicine, Seattle, Washington, USA.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'French', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Washington School of Medicine, Seattle, Washington, USA.'}, {'ForeName': 'Chuan', 'Initials': 'C', 'LastName': 'Zhou', 'Affiliation': ""Center for Child Health, Behavior and Development, Seattle Children's Research Institute, Seattle, Washington, USA.""}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Myers', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Washington School of Medicine, Seattle, Washington, USA.'}]",Journal of child and adolescent psychopharmacology,['10.1089/cap.2020.0013'] 592,32167792,Effects of Fish Oil Monotherapy on Depression and Prefrontal Neurochemistry in Adolescents at High Risk for Bipolar I Disorder: A 12-Week Placebo-Controlled Proton Magnetic Resonance Spectroscopy Trial.,"Objectives: To evaluate the clinical and neurochemical effects of 12-week fish oil, a source of omega-3 polyunsaturated fatty acids ( n -3 PUFAs), in depressed adolescents with a family history of bipolar I disorder. Methods: Adolescents with a current Diagnostic and Statistical Manual of Mental Disorders, 4th edition, Text Revision diagnosis of Major Depressive Disorder or Depressive Disorder not otherwise specified, a Childhood Depression Rating Scale-Revised (CDRS-R) Version raw score of ≥40, and at least one biological parent with bipolar I disorder were randomized to double-blind treatment with fish oil (2100 mg/day) or placebo for 12 weeks. The primary outcome measure was change in CDRS-R total score, and secondary outcomes measures were change in manic symptoms (Young Mania Rating Scale), global symptom and functioning measures (Clinical Global Impression-Severity [CGI-S] /CGI Improvement [CGI-I], Children's Global Assessment Scale, and Child Behavior Checklist), safety and laboratory measures, and anterior cingulate cortex (ACC) and bilateral ventrolateral prefrontal cortex neurometabolite concentrations using proton magnetic resonance spectroscopy at 4 T. Results: Fifty-six patients were randomized, and 42 completed the 12-week trial (placebo: n  = 21; fish oil, n  = 21). Subjects randomized to fish oil, but not placebo, exhibited a significant baseline to endpoint increase in erythrocyte n -3 PUFAs. Reductions in CDRS-R scores did not differ between treatment groups ( p  = 0.15), and similar remission ( p  = 0.58) and response ( p  = 0.77) rates were observed. Fish oil produced a significantly greater decrease in CGI-S ( p  = 0.0042) and CGI-I ( p  = 0.036) scores compared with placebo. Baseline to endpoint change in ACC creatine ( p  = 0.004) and ACC choline (Cho) ( p  = 0.024) differed significantly between groups. Baseline ACC Cho levels were inversely correlated with baseline and baseline to endpoint change in CDRS-R scores, and baseline to endpoint change in ACC Cho correlated with baseline-endpoint change in CDRS-R scores and n -3 PUFA. There were no group differences in safety and tolerability ratings or laboratory measures. Conclusions: Fish oil monotherapy was not superior to placebo for reducing depressive symptoms in high-risk youth as assessed by the CDRS-R, but was safe and well tolerated and superior to placebo on clinician ratings of global symptom improvement. Associations among ACC Cho levels, depression symptom severity, and n -3 PUFA warrant additional investigation.",2020,"Fish oil monotherapy was not superior to placebo for reducing depressive symptoms in high-risk youth as assessed by the CDRS-R, but was safe and well tolerated and superior to placebo on clinician ratings of global symptom improvement.","['Adolescents at High Risk for Bipolar I Disorder', 'Adolescents with a current Diagnostic and Statistical Manual of Mental Disorders, 4th edition, Text Revision diagnosis of Major Depressive Disorder or Depressive Disorder not otherwise specified, a Childhood Depression Rating Scale-Revised (CDRS-R) Version raw score of ≥40, and at least one biological parent with bipolar I disorder', 'depressed adolescents with a family history of bipolar I disorder']","['12-week fish oil, a source of omega-3 polyunsaturated fatty acids ( n -3 PUFAs', 'CGI', 'Fish oil monotherapy', 'placebo', 'fish oil', 'Fish Oil Monotherapy', 'Placebo', 'placebo: n \u2009=\u200921; fish oil, n \u2009=\u200921']","['CDRS-R scores', 'depressive symptoms', 'CGI', 'safety and tolerability ratings or laboratory measures', 'Baseline ACC Cho levels', 'change in CDRS-R total score', 'manic symptoms (Young Mania Rating Scale), global symptom and functioning measures (Clinical Global Impression-Severity [CGI-S', 'Depression and Prefrontal Neurochemistry', ""Improvement [CGI-I], Children's Global Assessment Scale, and Child Behavior Checklist), safety and laboratory measures, and anterior cingulate cortex (ACC) and bilateral ventrolateral prefrontal cortex neurometabolite concentrations"", 'ACC creatine', 'ACC choline (Cho', 'erythrocyte n -3 PUFAs', 'CGI-S', 'similar remission']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0853193', 'cui_str': 'Bipolar I disorder (disorder)'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C1136324', 'cui_str': 'Diagnostic and Statistical Manual of Mental Disorders'}, {'cui': 'C0205438', 'cui_str': 'Fourth (qualifier value)'}, {'cui': 'C0441792', 'cui_str': 'Editions (qualifier value)'}, {'cui': 'C3541382', 'cui_str': 'Text'}, {'cui': 'C0439617', 'cui_str': 'Revision - value'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C2363919', 'cui_str': 'Childhood depression'}, {'cui': 'C0222045'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0337465', 'cui_str': 'Natural parent (person)'}, {'cui': 'C0241889', 'cui_str': 'Family Medical History'}]","[{'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0016157', 'cui_str': 'Fish Oils'}, {'cui': 'C4521696', 'cui_str': 'Source (property)'}, {'cui': 'C1719844', 'cui_str': 'Greek letter omega'}, {'cui': 'C0032615', 'cui_str': 'Polyunsaturated Fatty Acids'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0338831', 'cui_str': 'Manic State'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C4087288', 'cui_str': 'Young mania rating scale'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0027820', 'cui_str': 'Neurochemistry'}, {'cui': 'C3472495', 'cui_str': ""Children's global assessment scale""}, {'cui': 'C0008065', 'cui_str': 'Child Behavior'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0175190', 'cui_str': 'Anterior Cingulate'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C3266730', 'cui_str': 'Ventrolateral'}, {'cui': 'C0162783', 'cui_str': 'Prefrontal Cortex'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0010286', 'cui_str': 'Creatine'}, {'cui': 'C0008405', 'cui_str': 'Choline'}, {'cui': 'C0014792', 'cui_str': 'Blood Corpuscles, Red'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}]",56.0,0.325419,"Fish oil monotherapy was not superior to placebo for reducing depressive symptoms in high-risk youth as assessed by the CDRS-R, but was safe and well tolerated and superior to placebo on clinician ratings of global symptom improvement.","[{'ForeName': 'Robert K', 'Initials': 'RK', 'LastName': 'McNamara', 'Affiliation': 'Division of Bipolar Disorders Research, Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, Cincinnati, Ohio, USA.'}, {'ForeName': 'Jeffrey R', 'Initials': 'JR', 'LastName': 'Strawn', 'Affiliation': 'Division of Bipolar Disorders Research, Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, Cincinnati, Ohio, USA.'}, {'ForeName': 'Max J', 'Initials': 'MJ', 'LastName': 'Tallman', 'Affiliation': 'Division of Bipolar Disorders Research, Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, Cincinnati, Ohio, USA.'}, {'ForeName': 'Jeffrey A', 'Initials': 'JA', 'LastName': 'Welge', 'Affiliation': 'Division of Bipolar Disorders Research, Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, Cincinnati, Ohio, USA.'}, {'ForeName': 'L Rodrigo', 'Initials': 'LR', 'LastName': 'Patino', 'Affiliation': 'Division of Bipolar Disorders Research, Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, Cincinnati, Ohio, USA.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Blom', 'Affiliation': 'Division of Bipolar Disorders Research, Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, Cincinnati, Ohio, USA.'}, {'ForeName': 'Melissa P', 'Initials': 'MP', 'LastName': 'DelBello', 'Affiliation': 'Division of Bipolar Disorders Research, Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, Cincinnati, Ohio, USA.'}]",Journal of child and adolescent psychopharmacology,['10.1089/cap.2019.0124'] 593,32173650,T-Cell Infiltration and Adaptive Treg Resistance in Response to Androgen Deprivation With or Without Vaccination in Localized Prostate Cancer.,"PURPOSE Previous studies suggest that androgen deprivation therapy (ADT) promotes antitumor immunity in prostate cancer. Whether a vaccine-based approach can augment this effect remains unknown. PATIENTS AND METHODS We conducted a neoadjuvant, randomized study to quantify the immunologic effects of a GM-CSF-secreting allogeneic cellular vaccine in combination with low-dose cyclophosphamide (Cy/GVAX) followed by degarelix versus degarelix alone in patients with high-risk localized prostate adenocarcinoma who were planned for radical prostatectomy. RESULTS Both Cy/GVAX plus degarelix and degarelix alone led to significant increases in intratumoral CD8 + T-cell infiltration and PD-L1 expression as compared with a cohort of untreated, matched controls. However, the CD8 + T-cell infiltrate was accompanied by a proportional increase in regulatory T cells (Treg), suggesting that adaptive Treg resistance may dampen the immunogenicity of ADT. Although Cy/GVAX followed by degarelix was associated with a modest improvement in time-to-PSA progression and time-to-next treatment, as well as an increase in PD-L1, there was no difference in the CD8 + T-cell infiltrate as compared with degarelix alone. Gene expression profiling demonstrated that CHIT1 , a macrophage marker, was differentially upregulated with Cy/GVAX plus degarelix compared with degarelix alone. CONCLUSIONS Our results highlight that ADT with or without Cy/GVAX induces a complex immune response within the prostate tumor microenvironment. These data have important implications for combining ADT with immunotherapy. In particular, our finding that ADT increases both CD8 + T cells and Tregs supports the development of regimens combining ADT with Treg-depleting agents in the treatment of prostate cancer.",2020,"Gene expression profiling demonstrated that CHIT1, a macrophage marker, was differentially upregulated with Cy/GVAX plus degarelix compared to degarelix alone. ","['prostate cancer', 'patients with high-risk localized prostate adenocarcinoma who were planned for radical prostatectomy', 'Localized Prostate Cancer']","['Androgen Deprivation', 'granulocyte-macrophage colony-stimulating factor (GM-CSF)-secreting allogeneic cellular vaccine', 'degarelix versus degarelix alone', 'cyclophosphamide (Cy/GVAX', 'ADT with or without Cy/GVAX', 'androgen deprivation therapy (ADT']","['PD-L1', 'CD8 T-cell infiltrate', 'time-to-PSA progression and time-to-next treatment', 'intratumoral CD8+ T cell infiltration and PD-L1 expression']","[{'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0392752', 'cui_str': 'Localized (qualifier value)'}, {'cui': 'C0033572', 'cui_str': 'Prostate'}, {'cui': 'C0001418', 'cui_str': 'Adenoma, Malignant'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C0194810', 'cui_str': 'Radical prostatectomy (procedure)'}]","[{'cui': 'C0002844', 'cui_str': 'Androgenic Compounds'}, {'cui': 'C0079460', 'cui_str': 'Tumor-Cell Human GM Colony-Stimulating Factor'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C1455035', 'cui_str': 'degarelix'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0279492', 'cui_str': 'Androgen deprivation therapy (procedure)'}]","[{'cui': 'C0039194', 'cui_str': 'Thymus-Dependent Lymphocytes'}, {'cui': 'C0332448', 'cui_str': 'Tissue infiltration'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0201544', 'cui_str': 'Prostate specific antigen measurement (procedure)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C3669041', 'cui_str': 'Spread by direct extension (qualifier value)'}, {'cui': 'C3854321', 'cui_str': 'Expression'}]",,0.02347,"Gene expression profiling demonstrated that CHIT1, a macrophage marker, was differentially upregulated with Cy/GVAX plus degarelix compared to degarelix alone. ","[{'ForeName': 'Aleksandar Z', 'Initials': 'AZ', 'LastName': 'Obradovic', 'Affiliation': 'Columbia Center for Translational Immunology, Columbia University Irving Medical Center, New York, New York.'}, {'ForeName': 'Matthew C', 'Initials': 'MC', 'LastName': 'Dallos', 'Affiliation': 'Division of Hematology and Oncology, Herbert Irving Comprehensive Cancer Center, Columbia University Medical Center, New York, New York.'}, {'ForeName': 'Marianna L', 'Initials': 'ML', 'LastName': 'Zahurak', 'Affiliation': 'Department of Oncology and Biostatistics, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland.'}, {'ForeName': 'Alan W', 'Initials': 'AW', 'LastName': 'Partin', 'Affiliation': 'Department of Urology, Brady Urological Institute, Johns Hopkins University, Baltimore, Maryland.'}, {'ForeName': 'Edward M', 'Initials': 'EM', 'LastName': 'Schaeffer', 'Affiliation': 'Department of Urology, Northwestern University Feinberg School of Medicine, Chicago, Illinois.'}, {'ForeName': 'Ashley E', 'Initials': 'AE', 'LastName': 'Ross', 'Affiliation': 'Texas Urology Specialists, Dallas, Texas.'}, {'ForeName': 'Mohamad E', 'Initials': 'ME', 'LastName': 'Allaf', 'Affiliation': 'Department of Urology, Brady Urological Institute, Johns Hopkins University, Baltimore, Maryland.'}, {'ForeName': 'Thomas R', 'Initials': 'TR', 'LastName': 'Nirschl', 'Affiliation': 'Department of Oncology, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Liu', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, Maryland.'}, {'ForeName': 'Carolyn G', 'Initials': 'CG', 'LastName': 'Chapman', 'Affiliation': 'Department of Oncology, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland.'}, {'ForeName': 'Tanya', 'Initials': 'T', 'LastName': ""O'Neal"", 'Affiliation': 'Department of Oncology, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland.'}, {'ForeName': 'Haiyi', 'Initials': 'H', 'LastName': 'Cao', 'Affiliation': 'Department of Oncology, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland.'}, {'ForeName': 'Jennifer N', 'Initials': 'JN', 'LastName': 'Durham', 'Affiliation': 'Department of Oncology, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland.'}, {'ForeName': 'Gunes', 'Initials': 'G', 'LastName': 'Guner', 'Affiliation': 'Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Javier A', 'Initials': 'JA', 'LastName': 'Baena-Del Valle', 'Affiliation': 'Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Onur', 'Initials': 'O', 'LastName': 'Ertunc', 'Affiliation': 'Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Angelo M', 'Initials': 'AM', 'LastName': 'De Marzo', 'Affiliation': 'Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Emmanuel S', 'Initials': 'ES', 'LastName': 'Antonarakis', 'Affiliation': 'Department of Oncology, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland.'}, {'ForeName': 'Charles G', 'Initials': 'CG', 'LastName': 'Drake', 'Affiliation': 'Columbia Center for Translational Immunology, Columbia University Irving Medical Center, New York, New York. cgd2139@cumc.columbia.edu.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-19-3372'] 594,31063869,Design of a randomized controlled trial examining the efficacy of oxytocin to enhance alcohol behavioral couple therapy.,"Combining pharmacological interventions with evidence-based behavioral interventions may help optimize treatment outcomes for alcohol use disorder (AUD). While several effective behavioral interventions for AUD have been developed, the vast majority target individual patients, despite evidence that behavioral interventions for couples have the ability to outperform individual treatments for AUD. Alcohol Behavioral Couples Therapy (ABCT) is an evidence-based behavioral intervention for couples that has been shown to significantly reduce AUD severity as well as improve relationship functioning. Accumulating evidence suggests that the neuropeptide oxytocin has the ability to reduce alcohol craving and consumption, symptoms of tolerance and withdrawal, and ameliorate neurobiological deficits associated with AUD. Furthermore, oxytocin has demonstrated the ability to increase prosocial behavior and cognition, and restore sensitivity to natural rewards such as interpersonal relationships. No study to date has examined the ability of oxytocin to enhance ABCT. Thus, the primary objective of this Phase II study is to examine the effects of oxytocin versus placebo in combination with ABCT in reducing AUD severity and improving relationship functioning. We also will utilize neuroimaging techniques before and after treatment to investigate the underlying pathophysiology of AUD among couples and identify prognostic indicators of treatment outcome. The findings from this study might provide critical new information to help inform clinical practice and accelerate research on the pharmacological treatment of AUD.",2019,Alcohol Behavioral Couples Therapy (ABCT) is an evidence-based behavioral intervention for couples that has been shown to significantly reduce AUD severity as well as improve relationship functioning.,[],"['oxytocin versus placebo', 'neuropeptide oxytocin', 'Alcohol Behavioral Couples Therapy (ABCT', 'ABCT', 'oxytocin']","['alcohol craving and consumption, symptoms of tolerance and withdrawal', 'prosocial behavior and cognition', 'AUD severity and improving relationship functioning']",[],"[{'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0027895', 'cui_str': 'Neuropeptides'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0302822', 'cui_str': 'Couples Therapy'}]","[{'cui': 'C0556385', 'cui_str': 'Craving for alcohol (finding)'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0231197', 'cui_str': 'Tolerance, function (observable entity)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0439849', 'cui_str': 'Relationships (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}]",,0.0307881,Alcohol Behavioral Couples Therapy (ABCT) is an evidence-based behavioral intervention for couples that has been shown to significantly reduce AUD severity as well as improve relationship functioning.,"[{'ForeName': 'Julianne C', 'Initials': 'JC', 'LastName': 'Flanagan', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, USA. Electronic address: hellmuth@musc.edu.'}, {'ForeName': 'Jane E', 'Initials': 'JE', 'LastName': 'Joseph', 'Affiliation': 'Department of Neuroscience, College of Medicine, Medical University of South Carolina, Charleston, SC, USA. Electronic address: josep@musc.edu.'}, {'ForeName': 'Paul J', 'Initials': 'PJ', 'LastName': 'Nietert', 'Affiliation': 'Department of Public Health Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, USA. Electronic address: nieterpj@musc.edu.'}, {'ForeName': 'Sudie E', 'Initials': 'SE', 'LastName': 'Back', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC, USA; Ralph H. Johnson Veterans Affairs Medical Center, Charleston, SC, USA. Electronic address: backs@musc.edu.'}, {'ForeName': 'Barbara S', 'Initials': 'BS', 'LastName': 'McCrady', 'Affiliation': 'The Center on Alcoholism, Substance Abuse, and Addictions, University of New Mexico, Albuquerque, NM, USA. Electronic address: bmccrady@unm.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2019.05.002'] 595,31783777,"Hygiene protocols for the treatment of denture-related stomatitis: local and systemic parameters analysis - a randomized, double-blind trial protocol.","BACKGROUND Denture-related stomatitis (DS) is chronic multifactorial inflammation, strongly related to the presence of the biofilm that is the complex structure formed by microorganisms held together by a mucus-like matrix of carbohydrate that adheres to different surfaces, including the denture surface. DS has recently been correlated with deleterious cardiovascular alterations. The potential effect of hygiene protocols in the control of DS and randomized clinical trials that address this oral condition with cardiovascular complications are important in clinical decision-making. MATERIAL/DESIGN A clinical trial, randomized, double-blind, and with parallel groups, will be conducted in Brazil The sample will consist of 100 patients without teeth in both arches, users of at least maxillary complete dentures, and diagnosed with DS, who will be allocated to groups (n = 25 per group) according to the different hygiene protocols: (1) brushing of the palate and immersion of the prosthesis in 0.25% sodium hypochlorite solution (positive control); (2) brushing of the palate and immersion of the prosthesis in 0.15% triclosan solution; (3) brushing of the palate and immersion of the prosthesis in lactose monohydrate; or (4) brushing the palate with citric acid and immersing the prosthesis in lactose monohydrate. The response variables will be heart rate variability and alteration of blood pressure (systemic level), remission of DS, removal of biofilm, reduction of microbial load (colony-forming units (CFU)), mouth and prosthesis odor level, expression of MUC1, proinflammatory cytokines, C-reactive protein (CRP), viscosity, pH and salivary flow (locally); patient-centred qualitative analysis will also be undertaken. Measurements will be performed at baseline and 10 days after the interventions. The results obtained will be statistically analyzed as pertinent, with a level of significance of 0.05. DISCUSSION This study will provide a guideline for clinical practice regarding the use of hygiene protocols in the treatment of oral diseases (DS) mediated by biofilm. Also, it may provide evidence of correlation of oral manifestation with cardiac risk. TRIAL REGISTRATION Brazilian Registry of Clinical Trials, RBR-4hhwjb. Registered on 9 November 2018.",2019,This study will provide a guideline for clinical practice regarding the use of hygiene protocols in the treatment of oral diseases (DS) mediated by biofilm.,"['denture-related stomatitis', '100 patients without teeth in both arches, users of at least maxillary complete dentures, and diagnosed with DS']","['Brazil', 'hygiene protocols: (1) brushing of the palate and immersion of the prosthesis in 0.25% sodium hypochlorite solution (positive control); (2) brushing of the palate and immersion of the prosthesis in 0.15% triclosan solution; (3) brushing of the palate and immersion of the prosthesis in lactose monohydrate; or (4) brushing the palate with citric acid and immersing the prosthesis in lactose monohydrate']","['heart rate variability and alteration of blood pressure (systemic level), remission of DS, removal of biofilm, reduction of microbial load (colony-forming units (CFU)), mouth and prosthesis odor level, expression of MUC1, proinflammatory cytokines, C-reactive protein (CRP), viscosity, pH and salivary flow (locally); patient-centred qualitative analysis']","[{'cui': 'C0011394', 'cui_str': 'Dentures'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0038362', 'cui_str': 'Stomatitis'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0040426', 'cui_str': 'Tooth'}, {'cui': 'C0011455', 'cui_str': 'Denture, Complete'}]","[{'cui': 'C0006137', 'cui_str': 'Brazil'}, {'cui': 'C0020405', 'cui_str': 'Hygiene'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0443165', 'cui_str': 'Brushing, function (observable entity)'}, {'cui': 'C0700374', 'cui_str': 'Palate'}, {'cui': 'C0020940', 'cui_str': 'Immersion'}, {'cui': 'C0175649', 'cui_str': 'Prosthesis'}, {'cui': 'C4517443', 'cui_str': '0.25 (qualifier value)'}, {'cui': 'C0037518', 'cui_str': 'Sodium Hypochlorite'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C4068886', 'cui_str': '0.15 (qualifier value)'}, {'cui': 'C0040958', 'cui_str': 'Triclosan'}, {'cui': 'C1658042', 'cui_str': 'Lactose Monohydrate'}, {'cui': 'C0055819', 'cui_str': 'Citric Acid'}]","[{'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0015252', 'cui_str': 'Removal - action (qualifier value)'}, {'cui': 'C0081786', 'cui_str': 'Biofilms'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0439158', 'cui_str': 'colonies (qualifier value)'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0230028', 'cui_str': 'Structure of oral region of face'}, {'cui': 'C0175649', 'cui_str': 'Prosthesis'}, {'cui': 'C0028884', 'cui_str': 'Odors'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C4301986', 'cui_str': 'Viscosity (property) (qualifier value)'}, {'cui': 'C0442040', 'cui_str': 'Salivary (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0205556', 'cui_str': 'Qualitative (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}]",100.0,0.295145,This study will provide a guideline for clinical practice regarding the use of hygiene protocols in the treatment of oral diseases (DS) mediated by biofilm.,"[{'ForeName': 'Adriana B', 'Initials': 'AB', 'LastName': 'Ribeiro', 'Affiliation': 'Department of Dental Materials and Prosthodontics, School of Dentistry of Ribeirão Preto, University of São Paulo (USP), Ribeirão Preto, Brazil.'}, {'ForeName': 'Camila B', 'Initials': 'CB', 'LastName': 'de Araújo', 'Affiliation': 'Department of Dental Materials and Prosthodontics, School of Dentistry of Ribeirão Preto, University of São Paulo (USP), Ribeirão Preto, Brazil.'}, {'ForeName': 'Luiz Eduardo V', 'Initials': 'LEV', 'LastName': 'Silva', 'Affiliation': 'Department of Physiology, Ribeirão Preto Medical School, University of São Paulo (USP), Ribeirão Preto, Brazil.'}, {'ForeName': 'Rubens', 'Initials': 'R', 'LastName': 'Fazan-Junior', 'Affiliation': 'Department of Physiology, Ribeirão Preto Medical School, University of São Paulo (USP), Ribeirão Preto, Brazil.'}, {'ForeName': 'Helio C', 'Initials': 'HC', 'LastName': 'Salgado', 'Affiliation': 'Department of Physiology, Ribeirão Preto Medical School, University of São Paulo (USP), Ribeirão Preto, Brazil.'}, {'ForeName': 'Aline B', 'Initials': 'AB', 'LastName': 'Ribeiro', 'Affiliation': 'Department of Physiology, Ribeirão Preto Medical School, University of São Paulo (USP), Ribeirão Preto, Brazil.'}, {'ForeName': 'Caroline V', 'Initials': 'CV', 'LastName': 'Fortes', 'Affiliation': 'Department of Dental Materials and Prosthodontics, School of Dentistry of Ribeirão Preto, University of São Paulo (USP), Ribeirão Preto, Brazil.'}, {'ForeName': 'Frank L', 'Initials': 'FL', 'LastName': 'Bueno', 'Affiliation': 'Department of Dental Materials and Prosthodontics, School of Dentistry of Ribeirão Preto, University of São Paulo (USP), Ribeirão Preto, Brazil.'}, {'ForeName': 'Viviane C', 'Initials': 'VC', 'LastName': 'de Oliveira', 'Affiliation': 'Department of Dental Materials and Prosthodontics, School of Dentistry of Ribeirão Preto, University of São Paulo (USP), Ribeirão Preto, Brazil.'}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'de F O Paranhos', 'Affiliation': 'Department of Dental Materials and Prosthodontics, School of Dentistry of Ribeirão Preto, University of São Paulo (USP), Ribeirão Preto, Brazil.'}, {'ForeName': 'Evandro', 'Initials': 'E', 'LastName': 'Watanabe', 'Affiliation': 'Department of Restorative Dentistry, School of Dentistry of Ribeirão Preto, University of São Paulo, Ribeirão Preto, Brazil.'}, {'ForeName': 'Cláudia H', 'Initials': 'CH', 'LastName': 'da Silva-Lovato', 'Affiliation': 'Department of Dental Materials and Prosthodontics, School of Dentistry of Ribeirão Preto, University of São Paulo (USP), Ribeirão Preto, Brazil. chl@forp.usp.br.'}]",Trials,['10.1186/s13063-019-3854-x'] 596,32180219,The combination of ibrutinib and rituximab demonstrates activity in first-line follicular lymphoma.,"This phase 2 study evaluated the activity and safety of ibrutinib, a Bruton's tyrosine kinase inhibitor, plus rituximab in adults with previously untreated follicular lymphoma. Patients received once-daily ibrutinib 560 mg continuously plus once-weekly rituximab 375 mg/m 2 for 4 weeks beginning Week 1 (Arm 1, n = 60) or Week 9 (following an 8-week ibrutinib lead-in) to explore biomarkers (Arm 2, n = 20). The primary endpoint was the best overall response rate (ORR). The median age was 58 years; most had an Eastern Cooperative Oncology Group Performance Status of 0 (74%) and Stage III/IV disease (84%). At a median study follow-up of 34 months in Arm 1 and 29 months in Arm 2, ORRs were 85% [95% confidence interval (CI) 73-93] and 75% (95% CI 51-91), respectively, with complete responses in 40% and 50%. The median duration of response was not reached in either arm; 30-month progression-free and overall survival rates were 67% and 97% (Arm 1) and 65% and 100% (Arm 2). The most common adverse events were fatigue, diarrhoea and nausea. Higher grade (Grade 3/4) haematological, haemorrhagic and cardiac events occurred infrequently. Ibrutinib plus rituximab was active and tolerable in first-line follicular lymphoma.",2020,The median duration of response was not reached in either arm; 30-month progression-free and overall survival rates were 67% and 97% (Arm 1) and 65% and 100% (Arm 2).,"['adults with previously untreated follicular lymphoma', 'The median age was 58\xa0years; most had an Eastern Cooperative Oncology Group Performance Status of 0 (74%) and Stage III/IV disease (84', 'first-line follicular lymphoma']","['Ibrutinib plus rituximab', 'ibrutinib and rituximab']","['fatigue, diarrhoea and nausea', 'median duration of response', 'Higher grade (Grade 3/4) haematological, haemorrhagic and cardiac events', 'ORRs', 'overall survival rates', 'overall response rate (ORR']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0024301', 'cui_str': 'Brill-Symmers Disease'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1520224', 'cui_str': 'Eastern Cooperative Oncology Group performance status'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3 (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}]","[{'cui': 'C3501358', 'cui_str': 'Ibrutinib'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}]","[{'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C1962917', 'cui_str': 'High grade (lymphoma)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0442757', 'cui_str': '3/4'}, {'cui': 'C0333275', 'cui_str': 'Hemorrhagic (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}]",,0.118287,The median duration of response was not reached in either arm; 30-month progression-free and overall survival rates were 67% and 97% (Arm 1) and 65% and 100% (Arm 2).,"[{'ForeName': 'Nathan H', 'Initials': 'NH', 'LastName': 'Fowler', 'Affiliation': 'University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Loretta', 'Initials': 'L', 'LastName': 'Nastoupil', 'Affiliation': 'University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Sven', 'Initials': 'S', 'LastName': 'De Vos', 'Affiliation': 'David Geffen School of Medicine at the University of California Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Knapp', 'Affiliation': 'Zangmeister Cancer Center, Columbus, OH, USA.'}, {'ForeName': 'Ian W', 'Initials': 'IW', 'LastName': 'Flinn', 'Affiliation': 'Sarah Cannon Research Institute, Nashville, TN, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Chen', 'Affiliation': 'City of Hope, Duarte, CA, USA.'}, {'ForeName': 'Ranjana H', 'Initials': 'RH', 'LastName': 'Advani', 'Affiliation': 'Stanford University School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Sumeet', 'Initials': 'S', 'LastName': 'Bhatia', 'Affiliation': 'Community Health Network, Indianapolis, IN, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Martin', 'Affiliation': 'Weill Cornell Medical College, New York, NY, USA.'}, {'ForeName': 'Raul', 'Initials': 'R', 'LastName': 'Mena', 'Affiliation': 'Providence St. Joseph Medical Center, Burbank, CA, USA.'}, {'ForeName': 'Richard Eric', 'Initials': 'RE', 'LastName': 'Davis', 'Affiliation': 'University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Sattva S', 'Initials': 'SS', 'LastName': 'Neelapu', 'Affiliation': 'University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Karl', 'Initials': 'K', 'LastName': 'Eckert', 'Affiliation': 'Pharmacyclics LLC, an AbbVie Company, Sunnyvale, CA, USA.'}, {'ForeName': 'Jerry', 'Initials': 'J', 'LastName': 'Ping', 'Affiliation': 'Pharmacyclics LLC, an AbbVie Company, Sunnyvale, CA, USA.'}, {'ForeName': 'Melannie', 'Initials': 'M', 'LastName': 'Co', 'Affiliation': 'Pharmacyclics LLC, an AbbVie Company, Sunnyvale, CA, USA.'}, {'ForeName': 'Darrin M', 'Initials': 'DM', 'LastName': 'Beaupre', 'Affiliation': 'Pharmacyclics LLC, an AbbVie Company, Sunnyvale, CA, USA.'}, {'ForeName': 'Jutta K', 'Initials': 'JK', 'LastName': 'Neuenburg', 'Affiliation': 'Pharmacyclics LLC, an AbbVie Company, Sunnyvale, CA, USA.'}, {'ForeName': 'M Lia', 'Initials': 'ML', 'LastName': 'Palomba', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}]",British journal of haematology,['10.1111/bjh.16424'] 597,32181610,Low-level laser therapy for neurosensory recovery after sagittal ramus osteotomy.,"BACKGROUND Dento-skeletal deformities are treated combining orthodontic treatment with orthognathic surgery. One of the techniques most used in this type of surgery is the sagittal osteotomy of the mandible. This technique offers many advantages, but within its disadvantages is the inferior alveolar nerve paresthesia. There are various treatments that aim to recovery of the nerve bundle, and one of them is low intensity laser treatment. The aim of this study was to evaluate the effectiveness of low intensity laser therapy in the recovery of neurosensorial tissues after mandibular sagittal osteotomy during orthognathic surgery. METHODS Twelve patients submitted to surgery, using mandibular sagittal osteotomy, were treated unilaterally with low intensity infrared (808 nm, GaAIAs active medium) laser, following the inferior alveolar nerve path. The other part of the mandible was treated by placebo. The parameters used were 100 mW of power, irradiancy of 3.6 W/cm2, 2.8J energy per point, an energy density of 100 J/cm2, 28 seconds at each point with a distance of 1.0 cm between points, two sessions per week with a minimum of 10 sessions, starting 48 hours after surgery. Mechanical evaluation was performed in first, fourth, seventh and tenth session. RESULTS Significant improvement on the treated side was observed. Comparing the behavior among the variables between the treatment (T) group and the control (C) group in the General Recovery was showed a tendency to better results in the T group when compared to the C group, with statistical difference (P≤0.05) after the 10th laser therapy session. CONCLUSIONS The treatment of neurosensorial disorders with infrared low intensity laser could be effective in accelerating recovery, providing greater comfort to the patient, and it presents advantages over other existing methods.",2020,"Comparing the behaviour among the variables between the T group and the C group in the General Recovery was showed a tendency to better results in the T group when compared to the C group, with statistical difference (p≤0,05) after the 10th laser therapy session. ","['Twelve patients submitted to surgery, using mandibular sagittal osteotomy', 'mandibular sagittal osteotomy during orthognathic surgery', 'neurosensory recovery after sagittal ramus osteotomy']","['infrared low intensity laser', 'low intensity laser therapy', 'placebo', 'low intensity infrared (808 nm, GaAIAs active medium) laser', 'orthognathic surgery', 'Low-level laser therapy']",[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0205129', 'cui_str': 'Sagittal (qualifier value)'}, {'cui': 'C0029468', 'cui_str': 'Osteotomy'}, {'cui': 'C0185624', 'cui_str': 'Orthognathic Surgery'}]","[{'cui': 'C3873737', 'cui_str': 'Low-intensity laser (physical object)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0596836', 'cui_str': 'Low intensity'}, {'cui': 'C1532326', 'cui_str': 'Infrared'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0439536', 'cui_str': 'Medium (qualifier value)'}, {'cui': 'C0023089', 'cui_str': 'Lasers'}, {'cui': 'C0185624', 'cui_str': 'Orthognathic Surgery'}, {'cui': 'C0279027', 'cui_str': 'Low-Power Laser Therapy'}]",[],12.0,0.0455081,"Comparing the behaviour among the variables between the T group and the C group in the General Recovery was showed a tendency to better results in the T group when compared to the C group, with statistical difference (p≤0,05) after the 10th laser therapy session. ","[{'ForeName': 'Paulo', 'Initials': 'P', 'LastName': 'Esteves Pinto Faria', 'Affiliation': 'University of Ribeirao Preto (UNAERP), Ribeirao Preto, Brazil - p.faria@me.com.'}, {'ForeName': 'Astrid', 'Initials': 'A', 'LastName': 'Temprano', 'Affiliation': 'Private Practitioner, São Paulo, Brazil.'}, {'ForeName': 'Fábio', 'Initials': 'F', 'LastName': 'Piva', 'Affiliation': 'Private Practitioner, São Paulo, Brazil.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': ""Sant'ana"", 'Affiliation': 'Department of Stomatology, Bauru Dental School, University of São Paulo, Bauru, Brazil.'}, {'ForeName': 'Dênis', 'Initials': 'D', 'LastName': 'Pimenta', 'Affiliation': 'Private Practitioner, São Paulo, Brazil.'}]",Minerva stomatologica,['10.23736/S0026-4970.20.04289-2'] 598,31263057,Body Composition and Aspirin Dose for Colorectal Adenoma Prevention in a Randomized Clinical Trial.,"BACKGROUND Visceral adiposity is a risk factor for colorectal adenomas, and aspirin is an established chemopreventive agent. Evidence from clinical trials suggests the effectiveness of aspirin at preventing cardiovascular disease and cancer may require higher doses for higher body weight. METHODS Body mass index, body surface area, fat-free mass, and fat mass were calculated from baseline height and weight in 1,121 participants of the Aspirin/Folate Polyp Prevention Study, a double-blind, placebo-controlled, 3 × 2 factorial randomized clinical trial of low-dose (81 mg/day) or high-dose (325 mg/day) aspirin and/or 1 mg/day folic acid to prevent metachronous colorectal adenomas. Participants were treated during a surveillance colonoscopy interval of approximately 3 years. Risk ratios (RR) with 95% confidence intervals (CI) for any colorectal neoplasia and high-risk adenoma (HRA, advanced or ≥3 adenomas) were estimated from log-linear regression. RESULTS We did not find evidence to suggest aspirin dose-response differed by body composition measurements, including weight alone. Among those weighing ≥ 80 kg, treatment effects for low-dose aspirin (RR for colorectal neoplasia, 0.75; 95% CI, 0.60-0.94; RR for HRA, 0.52; 95% CI, 0.31-0.86) and high-dose aspirin (RR for colorectal neoplasia, 0.88; 95% CI, 0.72-1.08; RR for HRA, 0.68; 95% CI, 0.43-1.09) were not meaningfully different than for those weighing 70-79 kg or <70 kg. CONCLUSIONS Measurements of body composition calculated from height and weight did not modify aspirin treatment effects for colorectal adenoma prevention. IMPACT Aspirin dosing strategies accounting for body weight suggested in previous trials of colorectal cancer may not apply to adenomas.",2019,"Among those weighing ≥ 80 kg, treatment effects for low-dose aspirin (RR for colorectal neoplasia, 0.75; 95% CI, 0.60-0.94; RR for HRA, 0.52; 95% CI, 0.31-0.86) and high-dose aspirin (RR for colorectal neoplasia, 0.88; 95% CI, 0.72-1.08; RR for HRA, 0.68; 95% CI, 0.43-1.09) were not meaningfully different than for those weighing 70-79 kg or <70 kg. ","['1,121 participants of the Aspirin/Folate Polyp Prevention Study, a double-blind']","['folic acid', 'Aspirin', 'aspirin', 'placebo']","['Risk ratios (RR', 'colorectal neoplasia and high-risk adenoma (HRA, advanced or ≥3 adenomas']","[{'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}, {'cui': 'C0178638', 'cui_str': 'Folate'}, {'cui': 'C0032584', 'cui_str': 'Polyp (morphologic abnormality)'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}]","[{'cui': 'C0016410', 'cui_str': 'Folic Acid'}, {'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0028873', 'cui_str': 'Risk Ratio'}, {'cui': 'C0555952', 'cui_str': 'Colorectal (qualifier value)'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0001430', 'cui_str': 'Adenoma'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}]",,0.428762,"Among those weighing ≥ 80 kg, treatment effects for low-dose aspirin (RR for colorectal neoplasia, 0.75; 95% CI, 0.60-0.94; RR for HRA, 0.52; 95% CI, 0.31-0.86) and high-dose aspirin (RR for colorectal neoplasia, 0.88; 95% CI, 0.72-1.08; RR for HRA, 0.68; 95% CI, 0.43-1.09) were not meaningfully different than for those weighing 70-79 kg or <70 kg. ","[{'ForeName': 'Michael N', 'Initials': 'MN', 'LastName': 'Passarelli', 'Affiliation': 'Department of Epidemiology, Geisel School of Medicine at Dartmouth, Hanover, New Hampshire. michael.n.passarelli@dartmouth.edu.'}, {'ForeName': 'Elizabeth L', 'Initials': 'EL', 'LastName': 'Barry', 'Affiliation': 'Department of Epidemiology, Geisel School of Medicine at Dartmouth, Hanover, New Hampshire.'}, {'ForeName': 'Judy R', 'Initials': 'JR', 'LastName': 'Rees', 'Affiliation': 'Department of Epidemiology, Geisel School of Medicine at Dartmouth, Hanover, New Hampshire.'}, {'ForeName': 'Leila A', 'Initials': 'LA', 'LastName': 'Mott', 'Affiliation': 'Department of Epidemiology, Geisel School of Medicine at Dartmouth, Hanover, New Hampshire.'}, {'ForeName': 'Dennis J', 'Initials': 'DJ', 'LastName': 'Ahnen', 'Affiliation': 'Department of Medicine, University of Colorado School of Medicine, Aurora, Colorado.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Baron', 'Affiliation': 'Department of Epidemiology, Geisel School of Medicine at Dartmouth, Hanover, New Hampshire.'}]","Cancer epidemiology, biomarkers & prevention : a publication of the American Association for Cancer Research, cosponsored by the American Society of Preventive Oncology",['10.1158/1055-9965.EPI-19-0205'] 599,32124728,"Safety and Immunogenicity of Different Formulations of a Tetravalent Dengue Purified Inactivated Vaccine in Healthy Adults from Puerto Rico: Final Results after 3 Years of Follow-Up from a Randomized, Placebo-Controlled Phase I Study.","Four formulations of an investigational tetravalent dengue purified inactivated vaccine, administered as two doses one month (M) apart, were previously shown to be immunogenic and well-tolerated up to M13 of the phase I study NCT01702857. Here, we report results of the follow-up from M14 to year (Y) 3. One hundred healthy Puerto Rican adults, predominantly dengue virus (DENV)-primed, were randomized 1:1:1:1:1 to receive placebo or vaccine formulations: 1 μg/serotype/dose adjuvanted with aluminum, AS01 E or AS03 B , or aluminum-adjuvanted 4 μg/serotype/dose. No serious adverse events occurred. Two medically-attended potential immune-mediated disease cases, vaccination unrelated, were reported (groups 1 µg+Alum and 1 µg+AS03 B ). Of 14 instances of suspected dengue, none were laboratory confirmed. Geometric mean neutralizing antibody titers against DENV 1-4 waned from M14, but remained above pre-vaccination levels for DENV 1-3, with the highest values for group 1 µg+AS03 B : 1220.1, 920.5, 819.4, and 940.5 (Y2), and 1329.3, 1169.2, 1219.8, and 718.9 (Y3). All formulations appeared to be safe and immunogenic during the 3-year follow-up.",2020,"Geometric mean neutralizing antibody titers against DENV 1-4 waned from M14, but remained above pre-vaccination levels for DENV 1-3, with the highest values for group 1 µg+AS03 B : 1220.1, 920.5, 819.4, and 940.5 (Y2), and 1329.3, 1169.2, 1219.8, and 718.9 (Y3).","['One hundred healthy Puerto Rican adults, predominantly dengue virus (DENV)-primed', 'Healthy Adults from Puerto Rico']","['placebo or vaccine formulations: 1 μg/serotype/dose adjuvanted with aluminum, AS01 E or AS03 B , or aluminum-adjuvanted 4-μg /serotype/dose', 'Tetravalent Dengue Purified Inactivated Vaccine', 'Placebo']",['Safety and Immunogenicity'],"[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0034043', 'cui_str': 'Puerto Ricans'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0011315', 'cui_str': 'Breakbone Fever Virus'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0034044', 'cui_str': 'Puerto Rico'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0449550', 'cui_str': 'Serotype (UK)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0202311', 'cui_str': 'Aluminum measurement (procedure)'}, {'cui': 'C0011311', 'cui_str': 'Break-Bone Fever'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}]",100.0,0.0919901,"Geometric mean neutralizing antibody titers against DENV 1-4 waned from M14, but remained above pre-vaccination levels for DENV 1-3, with the highest values for group 1 µg+AS03 B : 1220.1, 920.5, 819.4, and 940.5 (Y2), and 1329.3, 1169.2, 1219.8, and 718.9 (Y3).","[{'ForeName': 'Clemente', 'Initials': 'C', 'LastName': 'Diaz', 'Affiliation': 'University of Puerto Rico School of Medicine, San Juan, Puerto Rico.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Koren', 'Affiliation': 'Walter Reed Army Institute of Research, Silver Spring, Maryland.'}, {'ForeName': 'Leyi', 'Initials': 'L', 'LastName': 'Lin', 'Affiliation': 'Walter Reed Army Institute of Research, Silver Spring, Maryland.'}, {'ForeName': 'Luis J', 'Initials': 'LJ', 'LastName': 'Martinez', 'Affiliation': 'Walter Reed Army Institute of Research, Silver Spring, Maryland.'}, {'ForeName': 'Kenneth H', 'Initials': 'KH', 'LastName': 'Eckels', 'Affiliation': 'Walter Reed Army Institute of Research, Silver Spring, Maryland.'}, {'ForeName': 'Maribel', 'Initials': 'M', 'LastName': 'Campos', 'Affiliation': 'University of Puerto Rico School of Medicine, San Juan, Puerto Rico.'}, {'ForeName': 'Richard G', 'Initials': 'RG', 'LastName': 'Jarman', 'Affiliation': 'Walter Reed Army Institute of Research, Silver Spring, Maryland.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'De La Barrera', 'Affiliation': 'Walter Reed Army Institute of Research, Silver Spring, Maryland.'}, {'ForeName': 'Edith', 'Initials': 'E', 'LastName': 'Lepine', 'Affiliation': 'GSK, Rockville, Maryland.'}, {'ForeName': 'Irma', 'Initials': 'I', 'LastName': 'Febo', 'Affiliation': 'University of Puerto Rico School of Medicine, San Juan, Puerto Rico.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Vaughn', 'Affiliation': 'GSK, Rockville, Maryland.'}, {'ForeName': 'Todd M', 'Initials': 'TM', 'LastName': 'Wilson', 'Affiliation': 'GSK, Rockville, Maryland.'}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Paris', 'Affiliation': 'GSK, Rockville, Maryland.'}, {'ForeName': 'Alexander C', 'Initials': 'AC', 'LastName': 'Schmidt', 'Affiliation': 'GSK, Rockville, Maryland.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Thomas', 'Affiliation': 'Walter Reed Army Institute of Research, Silver Spring, Maryland.'}]",The American journal of tropical medicine and hygiene,['10.4269/ajtmh.19-0461'] 600,32181756,"Safety, tolerability, and immunogenicity of influenza vaccination with a high-density microarray patch: Results from a randomized, controlled phase I clinical trial.","BACKGROUND The Vaxxas high-density microarray patch (HD-MAP) consists of a high density of microprojections coated with vaccine for delivery into the skin. Microarray patches (MAPs) offer the possibility of improved vaccine thermostability as well as the potential to be safer, more acceptable, easier to use, and more cost-effective for the administration of vaccines than injection by needle and syringe (N&S). Here, we report a phase I trial using the Vaxxas HD-MAP to deliver a monovalent influenza vaccine that was to the best of our knowledge the first clinical trial to evaluate the safety, tolerability, and immunogenicity of lower doses of influenza vaccine delivered by MAPs. METHODS AND FINDINGS HD-MAPs were coated with a monovalent, split inactivated influenza virus vaccine containing A/Singapore/GP1908/2015 H1N1 haemagglutinin (HA). Between February 2018 and March 2018, 60 healthy adults (age 18-35 years) in Melbourne, Australia were enrolled into part A of the study and vaccinated with either: HD-MAPs delivering 15 μg of A/Singapore/GP1908/2015 H1N1 HA antigen (A-Sing) to the volar forearm (FA); uncoated HD-MAPs; intramuscular (IM) injection of commercially available quadrivalent influenza vaccine (QIV) containing A/Singapore/GP1908/2015 H1N1 HA (15 μg/dose); or IM injection of H1N1 HA antigen (15 μg/dose). After 22 days' follow-up and assessment of the safety data, a further 150 healthy adults were enrolled and randomly assigned to 1 of 9 treatment groups. Participants (20 per group) were vaccinated with HD-MAPs delivering doses of 15, 10, 5, 2.5, or 0 μg of HA to the FA or 15 μg HA to the upper arm (UA), or IM injection of QIV. The primary objectives of the study were safety and tolerability. Secondary objectives were to assess the immunogenicity of the influenza vaccine delivered by HD-MAP. Primary and secondary objectives were assessed for up to 60 days post-vaccination. Clinical staff and participants were blind as to which HD-MAP treatment was administered and to administration of IM-QIV-15 or IM-A/Sing-15. All laboratory investigators were blind to treatment and participant allocation. Two further groups in part B (5 participants per group), not included in the main safety and immunological analysis, received HD-MAPs delivering 15 μg HA or uncoated HD-MAPs applied to the forearm. Biopsies were taken on days 1 and 4 for analysis of the cellular composition from the HD-MAP application sites. The vaccine coated onto HD-MAPs was antigenically stable when stored at 40°C for at least 12 months. HD-MAP vaccination was safe and well tolerated; any systemic or local adverse events (AEs) were mild or moderate. Observed systemic AEs were mostly headache or myalgia, and local AEs were application-site reactions, usually erythema. HD-MAP administration of 2.5 μg HA induced haemagglutination inhibition (HAI) and microneutralisation (MN) titres that were not significantly different to those induced by 15 μg HA injected IM (IM-QIV-15). HD-MAP delivery resulted in enhanced humoral responses compared with IM injection with higher HAI geometric mean titres (GMTs) at day 8 in the MAP-UA-15 (GMT 242.5, 95% CI 133.2-441.5), MAP-FA-15 (GMT 218.6, 95% CI 111.9-427.0), and MAP-FA-10 (GMT 437.1, 95% CI 254.3-751.3) groups compared with IM-QIV-15 (GMT 82.8, 95% CI 42.4-161.8), p = 0.02, p = 0.04, p < 0.001 for MAP-UA-15, MAP-FA-15, and MAP-FA-10, respectively. Higher titres were also observed at day 22 in the MAP-FA-10 (GMT 485.0, 95% CI 301.5-780.2, p = 0.001) and MAP-UA-15 (367.6, 95% CI 197.9-682.7, p = 0.02) groups compared with the IM-QIV-15 group (GMT 139.3, 95% CI 79.3-244.5). Results from a panel of exploratory immunoassays (antibody-dependent cellular cytotoxicity, CD4+ T-cell cytokine production, memory B cell (MBC) activation, and recognition of non-vaccine strains) indicated that, overall, Vaxxas HD-MAP delivery induced immune responses that were similar to, or higher than, those induced by IM injection of QIV. The small group sizes and use of a monovalent influenza vaccine were limitations of the study. CONCLUSIONS Influenza vaccine coated onto the HD-MAP was stable stored at temperatures up to 40°C. Vaccination using the HD-MAP was safe and well tolerated and resulted in immune responses that were similar to or significantly enhanced compared with IM injection. Using the HD-MAP, a 2.5 μg dose (1/6 of the standard dose) induced HAI and MN titres similar to those induced by 15 μg HA injected IM. TRIAL REGISTRATION Australian New Zealand Clinical Trials Registry (ANZCTR.org.au), trial ID 108 ACTRN12618000112268/U1111-1207-3550.",2020,Vaccination using the HD-MAP was safe and well tolerated and resulted in immune responses that were similar to or significantly enhanced compared with IM injection.,"['150 healthy adults', 'Between February 2018 and March 2018, 60 healthy adults (age 18-35 years) in Melbourne, Australia were enrolled into part A of the study and vaccinated with either']","['IM-QIV-15 or IM-A/Sing-15', 'monovalent, split inactivated influenza virus vaccine containing A/Singapore/GP1908/2015 H1N1 haemagglutinin (HA', 'HD-MAPs delivering 15 μg of A/Singapore/GP1908/2015 H1N1 HA antigen (A-Sing) to the volar forearm (FA); uncoated HD-MAPs; intramuscular (IM) injection of commercially available quadrivalent influenza vaccine (QIV) containing A/Singapore/GP1908/2015 H1N1 HA (15 μg/dose); or IM injection of H1N1 HA antigen', 'HD-MAPs delivering 15 μg HA or uncoated HD-MAPs applied to the forearm', 'influenza vaccine delivered by MAPs', 'HD-MAP vaccination', 'influenza vaccination with a high-density microarray patch', 'Influenza vaccine']","['MAP-UA-15', 'immunogenicity of the influenza vaccine delivered by HD-MAP', 'safety, tolerability, and immunogenicity', 'safety and tolerability', 'HAI and MN titres', 'Safety, tolerability, and immunogenicity', 'HAI geometric mean titres (GMTs', 'safe and well tolerated; any systemic or local adverse events (AEs', 'Higher titres', 'humoral responses', 'cellular cytotoxicity, CD4+ T-cell cytokine production, memory B cell (MBC) activation, and recognition of non-vaccine strains', 'safe and well tolerated', 'haemagglutination inhibition (HAI) and microneutralisation (MN) titres']","[{'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C1292718', 'cui_str': 'Is a'}, {'cui': 'C0021403', 'cui_str': 'Influenza Vaccines'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0037173', 'cui_str': 'Singapore'}, {'cui': 'C0580264', 'cui_str': 'H1N1'}, {'cui': 'C0024779', 'cui_str': 'Map'}, {'cui': 'C0003320', 'cui_str': 'Antigens'}, {'cui': 'C0443349', 'cui_str': 'Volar (qualifier value)'}, {'cui': 'C0016536', 'cui_str': 'Antebrachiums'}, {'cui': 'C0021492', 'cui_str': 'Intramuscular injection (procedure)'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C4318638', 'cui_str': 'Quadrivalent Influenza Vaccine'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0042200', 'cui_str': 'Influenza vaccination (procedure)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0178587', 'cui_str': 'Mass to volume ratio'}, {'cui': 'C0445403', 'cui_str': 'Human patch'}]","[{'cui': 'C0024779', 'cui_str': 'Map'}, {'cui': 'C0021403', 'cui_str': 'Influenza Vaccines'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0475208', 'cui_str': 'TITR'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0039194', 'cui_str': 'Thymus-Dependent Lymphocytes'}, {'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}, {'cui': 'C0033268'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0004561', 'cui_str': 'B-Cells'}, {'cui': 'C0524637', 'cui_str': 'Recognition (Psychology)'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0080194', 'cui_str': 'Strains'}, {'cui': 'C0018904', 'cui_str': 'Hemagglutination Inhibition Tests'}]",60.0,0.129819,Vaccination using the HD-MAP was safe and well tolerated and resulted in immune responses that were similar to or significantly enhanced compared with IM injection.,"[{'ForeName': 'Angus H', 'Initials': 'AH', 'LastName': 'Forster', 'Affiliation': 'Vaxxas Pty Ltd, Brisbane, Queensland, Australia.'}, {'ForeName': 'Katey', 'Initials': 'K', 'LastName': 'Witham', 'Affiliation': 'Vaxxas Pty Ltd, Brisbane, Queensland, Australia.'}, {'ForeName': 'Alexandra C I', 'Initials': 'ACI', 'LastName': 'Depelsenaire', 'Affiliation': 'Vaxxas Pty Ltd, Brisbane, Queensland, Australia.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Veitch', 'Affiliation': 'The University of Queensland Diamantina Institute, Faculty of Medicine, The University of Queensland, TRI, Brisbane, Queensland, Australia.'}, {'ForeName': 'James W', 'Initials': 'JW', 'LastName': 'Wells', 'Affiliation': 'The University of Queensland Diamantina Institute, Faculty of Medicine, The University of Queensland, TRI, Brisbane, Queensland, Australia.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Wheatley', 'Affiliation': 'Department of Microbiology and Immunology, University of Melbourne, at The Peter Doherty Institute for Infection and Immunity, Melbourne, Victoria, Australia.'}, {'ForeName': 'Melinda', 'Initials': 'M', 'LastName': 'Pryor', 'Affiliation': '360biolabs, Melbourne, Victoria, Australia.'}, {'ForeName': 'Jason D', 'Initials': 'JD', 'LastName': 'Lickliter', 'Affiliation': 'Nucleus Network Pty Ltd, Melbourne, Victoria, Australia.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Francis', 'Affiliation': 'Avance Clinical Pty Ltd, Thebarton, South Australia, Australia.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Rockman', 'Affiliation': 'Department of Microbiology and Immunology, University of Melbourne, at The Peter Doherty Institute for Infection and Immunity, Melbourne, Victoria, Australia.'}, {'ForeName': 'Jesse', 'Initials': 'J', 'LastName': 'Bodle', 'Affiliation': 'Seqirus Pty Ltd, Parkville, Victoria, Australia.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Treasure', 'Affiliation': 'Peter Treasure Statistical Services Ltd, Kings Lynn, United Kingdom.'}, {'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Hickling', 'Affiliation': 'Working in Tandem Ltd, Cambridge, United Kingdom.'}, {'ForeName': 'Germain J P', 'Initials': 'GJP', 'LastName': 'Fernando', 'Affiliation': 'Vaxxas Pty Ltd, Brisbane, Queensland, Australia.'}]",PLoS medicine,['10.1371/journal.pmed.1003024'] 601,32199095,"Safety and efficacy of rituximab in neuromyelitis optica spectrum disorders (RIN-1 study): a multicentre, randomised, double-blind, placebo-controlled trial.","BACKGROUND Pharmacological prevention against relapses in patients with neuromyelitis optica spectrum disorder (NMOSD) is developing rapidly. We aimed to investigate the safety and efficacy of rituximab, an anti-CD20 monoclonal antibody, against relapses in patients with NMOSD. METHODS We did a multicentre, randomised, double-blind, placebo-controlled clinical trial at eight hospitals in Japan. Patients aged 16-80 years with NMOSD who were seropositive for aquaporin 4 (AQP4) antibody, were taking 5-30 mg/day oral steroids, and had an Expanded Disability Status Scale (EDSS) score of 7·0 or less were eligible for the study. Individuals taking any other immunosuppressants were excluded. Participants were randomly allocated (1:1) either rituximab or placebo by a computer-aided dynamic random allocation system. The doses of concomitant steroid (converted to equivalent doses of prednisolone) and relapses in previous 2 years were set as stratification factors. Participants and those assessing outcomes were unaware of group assignments. Rituximab (375 mg/m 2 ) was administered intravenously every week for 4 weeks, then 6-month interval dosing was done (1000 mg every 2 weeks, at 24 weeks and 48 weeks after randomisation). A matching placebo was administered intravenously. Concomitant oral prednisolone was gradually reduced to 2-5 mg/day, according to the protocol. The primary outcome was time to first relapse within 72 weeks. Relapses were defined as patient-reported symptoms or any new signs consistent with CNS lesions and attributable objective changes in MRI or visual evoked potential. The primary analysis was done in the full analysis set (all randomly assigned patients) and safety analyses were done in the safety analysis set (all patients who received at least one infusion of assigned treatment). The primary analysis was by intention-to-treat principles. This trial is registered with the UMIN clinical trial registry, UMIN000013453. FINDINGS Between May 10, 2014, and Aug 15, 2017, 38 participants were recruited and randomly allocated either rituximab (n=19) or placebo (n=19). Three (16%) patients assigned rituximab discontinued the study and were analysed as censored cases. Seven (37%) relapses occurred in patients allocated placebo and none were recorded in patients assigned rituximab (group difference 36·8%, 95% CI 12·3-65·5; log-rank p=0·0058). Eight serious adverse events were recorded, four events in three (16%) patients assigned rituximab (lumbar compression fracture and infection around nail of right foot [n=1], diplopia [n=1], and uterine cancer [n=1]) and four events in two (11%) people allocated to placebo (exacerbation of glaucoma and bleeding in the right eye chamber after surgery [n=1], and visual impairment and asymptomatic white matter brain lesion on MRI [n=1]); all patients recovered. No deaths were reported. INTERPRETATION Rituximab prevented relapses for 72 weeks in patients with NMOSD who were AQP4 antibody-positive. This study is limited by its small sample size and inclusion of participants with mild disease activity. However, our results suggest that rituximab could be useful maintenance therapy for individuals with NMOSD who are AQP4 antibody-positive. FUNDING Japanese Ministry of Health, Labour and Welfare, Japan Agency for Medical Research and Development, and Zenyaku Kogyo.",2020,"No deaths were reported. ","['neuromyelitis optica spectrum disorders (RIN-1 study', 'Patients aged 16-80 years with NMOSD who were seropositive for aquaporin 4 (AQP4) antibody, were taking 5-30 mg/day oral steroids, and had an Expanded Disability Status Scale (EDSS) score of 7·0 or less were eligible for the study', 'patients with neuromyelitis optica spectrum disorder (NMOSD', 'individuals with NMOSD who are AQP4 antibody-positive', 'eight hospitals in Japan', 'Between May 10, 2014, and Aug 15, 2017, 38 participants', 'participants with mild disease activity', 'patients with NMOSD']","['concomitant steroid', 'Rituximab', 'rituximab or placebo', 'placebo', 'rituximab', 'prednisolone', 'Concomitant oral prednisolone']","['Safety and efficacy', 'Relapses', 'safety and efficacy', 'time to first relapse']","[{'cui': 'C0027873', 'cui_str': ""Devic's Neuromyelitis Optica""}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0521143', 'cui_str': 'Seropositive (qualifier value)'}, {'cui': 'C2919772', 'cui_str': 'Aquaporin-4 antibody'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0439422', 'cui_str': 'mg/day'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0038317', 'cui_str': 'Steroids'}, {'cui': 'C0451246', 'cui_str': 'Kurtzke multiple sclerosis rating scale (assessment scale)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0741132', 'cui_str': 'Antibody test positive'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}]","[{'cui': 'C0521115', 'cui_str': 'Simultaneous (qualifier value)'}, {'cui': 'C0038317', 'cui_str': 'Steroids'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0032950', 'cui_str': 'prednisolone'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",38.0,0.757995,"No deaths were reported. ","[{'ForeName': 'Masayuki', 'Initials': 'M', 'LastName': 'Tahara', 'Affiliation': 'Clinical Research Centre and Department of Neurology, National Hospital Organization Utano National Hospital, Kyoto, Japan. Electronic address: tahara.masayuki.ne@mail.hosp.go.jp.'}, {'ForeName': 'Tomoko', 'Initials': 'T', 'LastName': 'Oeda', 'Affiliation': 'Clinical Research Centre and Department of Neurology, National Hospital Organization Utano National Hospital, Kyoto, Japan.'}, {'ForeName': 'Kazumasa', 'Initials': 'K', 'LastName': 'Okada', 'Affiliation': 'Department of Neurology, University of Occupational and Environmental Health, Kitakyushu, Japan.'}, {'ForeName': 'Takao', 'Initials': 'T', 'LastName': 'Kiriyama', 'Affiliation': 'Department of Neurology, Nara Medical University School of Medicine, Nara, Japan.'}, {'ForeName': 'Kazuhide', 'Initials': 'K', 'LastName': 'Ochi', 'Affiliation': 'Department of Clinical Neuroscience and Therapeutics, Graduate School of Biomedical and Health Sciences, Hiroshima University, Hiroshima, Japan.'}, {'ForeName': 'Hirofumi', 'Initials': 'H', 'LastName': 'Maruyama', 'Affiliation': 'Department of Clinical Neuroscience and Therapeutics, Graduate School of Biomedical and Health Sciences, Hiroshima University, Hiroshima, Japan.'}, {'ForeName': 'Hikoaki', 'Initials': 'H', 'LastName': 'Fukaura', 'Affiliation': 'Department of Neurology, Saitama Medical University, Kawagoe, Japan.'}, {'ForeName': 'Kyoichi', 'Initials': 'K', 'LastName': 'Nomura', 'Affiliation': 'Department of Neurology, Saitama Medical University, Kawagoe, Japan.'}, {'ForeName': 'Yuko', 'Initials': 'Y', 'LastName': 'Shimizu', 'Affiliation': ""Department of Neurology, Tokyo Women's Medical University School of Medicine, Tokyo, Japan.""}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Mori', 'Affiliation': 'Department of Neurology, Graduate School of Medicine, Chiba University, Chiba, Japan.'}, {'ForeName': 'Ichiro', 'Initials': 'I', 'LastName': 'Nakashima', 'Affiliation': 'Department of Neurology, Tohoku Medical and Pharmaceutical University, Sendai, Japan.'}, {'ForeName': 'Tatsuro', 'Initials': 'T', 'LastName': 'Misu', 'Affiliation': 'Department of Neurology, Tohoku University Graduate School of Medicine, Sendai, Japan.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Umemura', 'Affiliation': 'Clinical Research Centre and Department of Neurology, National Hospital Organization Utano National Hospital, Kyoto, Japan.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Yamamoto', 'Affiliation': 'Clinical Research Centre and Department of Neurology, National Hospital Organization Utano National Hospital, Kyoto, Japan.'}, {'ForeName': 'Hideyuki', 'Initials': 'H', 'LastName': 'Sawada', 'Affiliation': 'Clinical Research Centre and Department of Neurology, National Hospital Organization Utano National Hospital, Kyoto, Japan.'}]",The Lancet. Neurology,['10.1016/S1474-4422(20)30066-1'] 602,32170438,Early vertebroplasty within 3 weeks of fracture for acute painful vertebral osteoporotic fractures: subgroup analysis of the VAPOUR trial and review of the literature.,"BACKGROUND VAPOUR found vertebroplasty (V) more effective than placebo (P) in patients with severe pain and fracture duration less than 6 weeks. Exploratory analysis suggested that benefits were concentrated in the subgroup of patients with fractures ≤ 3-week duration. This difference may account for the three negative blinded trials that included few patients within this fracture time frame. PURPOSE To assess the safety and efficacy of early vertebroplasty for acute painful vertebral osteoporotic fractures within 3 weeks of fracture onset in the VAPOUR study. METHODS Spearman's rank log coefficients were calculated to reassess the relationship of pain reduction from vertebroplasty and fracture duration in the VAPOUR trial. We more fully report baseline and outcome data in patients with fractures ≤ 3-week duration. RESULTS There were 46V and 47P patients with fractures ≤ 3-week duration. Baseline characteristics were similar. In total, 86 patients (41V, 45P) completed the 14-day questionnaire. The proportion of patients with reduction in pain from severe (NRS ≥ 7/10 was an inclusion requirement) to mild (NRS < 4) at 14 days was 21 (51%) V-group and 9 (20%) in the P-group (between-group difference 31 percentage points, 95% CI 12-50; p = 0.002). Early vertebroplasty provided greater reductions in mean NRS pain and Roland-Morris Disability. CONCLUSION Analysis of this patient subgroup from the VAPOUR trial, in the context of other randomised trial evidence, suggests clinically significant benefits from early vertebroplasty if performed within 3 weeks of fracture. These slides can be retrieved from Electronic Supplementary Material.",2020,"Early vertebroplasty provided greater reductions in mean NRS pain and Roland-Morris Disability. ","['patients with reduction in pain from severe (NRS\u2009≥', 'patients with fractures ≤\xa03-week duration', '86 patients (41V, 45P) completed the 14-day questionnaire', 'patients with severe pain and fracture duration less than 6\xa0weeks', '47P patients with fractures\u2009≤\u20093-week duration', 'acute painful vertebral osteoporotic fractures within 3\xa0weeks of fracture onset in the VAPOUR study', 'acute painful vertebral osteoporotic fractures']","['early vertebroplasty', 'placebo']","['safety and efficacy', 'mean NRS pain and Roland-Morris Disability']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0278140', 'cui_str': 'Severe pain (finding)'}, {'cui': 'C0521170', 'cui_str': 'Osteoporotic Fractures'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0597635', 'cui_str': 'Vapor (substance)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C1303192', 'cui_str': 'Vertebroplasty'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}]",86.0,0.270149,"Early vertebroplasty provided greater reductions in mean NRS pain and Roland-Morris Disability. ","[{'ForeName': 'Terrence', 'Initials': 'T', 'LastName': 'Diamond', 'Affiliation': 'St George and Sutherland Clinical School UNSW, St George Hospital, Sydney, NSW, Australia. terrydiamond@optusnet.com.au.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Clark', 'Affiliation': 'Interventional Radiology, St George Private Hospital, Sydney, NSW, Australia.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Bird', 'Affiliation': 'St George and Sutherland Clinical School UNSW, St George Hospital, Sydney, NSW, Australia.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Gonski', 'Affiliation': 'School of Public Health and Community Medicine, University of New South Wales, Sydney, NSW, Australia.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Barnes', 'Affiliation': 'NHMRC Clinical Trial Centre, University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Val', 'Initials': 'V', 'LastName': 'Gebski', 'Affiliation': 'NHMRC Clinical Trial Centre, University of Sydney, Sydney, NSW, Australia.'}]","European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society",['10.1007/s00586-020-06362-2'] 603,32173464,"Bintrafusp Alfa, a Bifunctional Fusion Protein Targeting TGF-β and PD-L1, in Second-Line Treatment of Patients With NSCLC: Results From an Expansion Cohort of a Phase 1 Trial.","INTRODUCTION The safety and efficacy of bintrafusp alfa, a first-in-class bifunctional fusion protein composed of the extracellular domain of the transforming growth factor β (TGF-β) receptor II (a TGF-β ""trap"") fused to a human immunoglobulin G1 antibody blocking programmed death-ligand 1 (PD-L1), was evaluated in patients with advanced NSCLC. METHODS This expansion cohort of NCT02517398, an ongoing, phase 1, open-label trial, includes 80 patients with advanced NSCLC that progressed after platinum doublet therapy or after platinum-based adjuvant or neoadjuvant treatment and those who also have not received previous immunotherapy. Patients were randomized at a one-to-one ratio to receive either bintrafusp alfa 500 mg or the recommended phase 2 dosage of 1200 mg every 2 weeks. The primary end point was the best overall response (by Response Evaluation Criteria in Solid Tumors 1.1 as adjudicated by independent review committee) and was assessed by the objective response rate (ORR). RESULTS A total of 80 patients were randomized to receive bintrafusp alfa 500 or 1200 mg (n = 40 each). Median follow-up was 51.9 weeks (IQR, 19.6-74.0). The ORR in all patients was 21.3% (17 of 80). The ORR was 17.5% (seven of 40) and 25.0% (10 of 40) for the 500 mg dose and the 1200 mg dose (recommended phase 2 dose), respectively. At the 1200 mg dose, patients with PD-L1-positive and PD-L1-high (≥80% expression on tumor cells) had ORRs of 36.0% (10 of 27) and 85.7% (six of seven), respectively. Treatment-related adverse events occurred in 55 of the 80 patients (69%) and were graded as greater than or equal to 3 in 23 of the 80 patients (29%). Of the 80 patients, eight (10%) had a treatment-related adverse event that led to treatment discontinuation; no treatment-related deaths occurred. CONCLUSIONS Bintrafusp alfa had encouraging efficacy and manageable tolerability in patients with NSCLC previously treated with platinum.",2020,Treatment-related adverse events (TRAEs) occurred in 55/80 patients (69%) and were grade ≥3 in 23/80 patients (29%).,"['Eighty patients', 'patients with advanced non-small cell lung cancer (NSCLC', '80 patients with advanced NSCLC that progressed following platinum doublet therapy or after platinum-based adjuvant or neoadjuvant treatment who also have not received prior immunotherapy', 'patients with non-small cell lung cancer']",[],"['adverse events (TRAEs', 'objective response rate (ORR', 'ORR', 'overall response', 'efficacy and manageable tolerability', 'safety and efficacy']","[{'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant Treatment'}, {'cui': 'C0021083', 'cui_str': 'Immunotherapy'}]",[],"[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",80.0,0.165194,Treatment-related adverse events (TRAEs) occurred in 55/80 patients (69%) and were grade ≥3 in 23/80 patients (29%).,"[{'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Paz-Ares', 'Affiliation': 'HI2O-CNIO Haematological Malignancies Clinical Research Unit (Hospital Universitario 12 de Octubre-CNIO), Universidad Complutense & Ciberonc, Madrid, Spain. Electronic address: lpazares@seom.org.'}, {'ForeName': 'Tae Min', 'Initials': 'TM', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Seoul National University Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Vicente', 'Affiliation': 'Department of Clinical Oncology, Hospital Universitario Virgen Macarena, Seville, Spain.'}, {'ForeName': 'Enriqueta', 'Initials': 'E', 'LastName': 'Felip', 'Affiliation': ""Medical Oncology Department, Hospital Universitari de la Vall d'Hebron, Barcelona, Spain.""}, {'ForeName': 'Dae Ho', 'Initials': 'DH', 'LastName': 'Lee', 'Affiliation': 'Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Ki Hyeong', 'Initials': 'KH', 'LastName': 'Lee', 'Affiliation': 'Deparment of Internal Medicine, Chungbuk National University Hospital, Chungbuk National University College of Medicine, Cheongju, Republic of Korea.'}, {'ForeName': 'Chia-Chi', 'Initials': 'CC', 'LastName': 'Lin', 'Affiliation': 'Department of Oncology, National Taiwan University Hospital, Taipei, Taiwan.'}, {'ForeName': 'Maria Jose', 'Initials': 'MJ', 'LastName': 'Flor', 'Affiliation': 'Servicio de Oncología Médica, Hospital Universitario Virgen del Rocío, Seville, Spain.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Di Nicola', 'Affiliation': 'Unit of Immunotherapy and Anticancer Innovative Therapeutics, Fondazione IRCCS Istituto Nazionale Tumori, Milan, Italy.'}, {'ForeName': 'Rosa Maria', 'Initials': 'RM', 'LastName': 'Alvarez', 'Affiliation': 'Department of Medical Oncology, Gregorio Marañon Hospital, Madrid, Spain.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Dussault', 'Affiliation': 'EMD Serono Research & Development Institute, Inc., Billerica, Massachusetts; a business of Merck KGaA, Darmstadt, Germany; Merck KGaA, Darmstadt, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Helwig', 'Affiliation': 'Merck KGaA, Darmstadt, Germany.'}, {'ForeName': 'Laureen S', 'Initials': 'LS', 'LastName': 'Ojalvo', 'Affiliation': 'EMD Serono Research & Development Institute, Inc., Billerica, Massachusetts; a business of Merck KGaA, Darmstadt, Germany; Merck KGaA, Darmstadt, Germany.'}, {'ForeName': 'James L', 'Initials': 'JL', 'LastName': 'Gulley', 'Affiliation': 'Genitourinary Malignancies Branch, Center for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Byoung Chul', 'Initials': 'BC', 'LastName': 'Cho', 'Affiliation': 'Department of Internal Medicine, Division of Medical Oncology, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, Republic of Korea.'}]",Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer,['10.1016/j.jtho.2020.03.003'] 604,32153793,Clinical and echocardiographic characteristics of individuals aged 75/76 years old with screening-detected elevated NT-proBNP levels.,"Background High plasma levels of N-terminal pro-B-type natriuretic peptide (NT-proBNP) indicate increased probability of congestive heart failure (CHF) and atrial fibrillation (AF) and are associated with poor prognosis. Objective We aimed to describe the clinical and echocardiographic characteristics of a population of individuals aged 75/76 years old with NT-proBNP ≥900 ng/L without previously known CHF or AF. Methods All individuals aged 75/76 years in the Stockholm region were randomised to a screening study for AF. Half of them were invited to screening. Of those invited, 49.5% agreed to participate. Individuals with NT-proBNP ≥900 ng/L without known CHF were invited for further clinical evaluation. Results Among 6315 participants without AF who had NT-proBNP sampled, 102 without previously known CHF had ≥900 ng/L. Of these, 93 completed further clinical investigations. In the population that was clinically investigated, 53% were female, and the median NT-proBNP was 1200 ng/L. New AF was found in 28 (30%). The NT-proBNP value in this group was not significantly different from those where AF was not detected (median 1285 vs 1178 ng/L). Patients with newly detected AF had larger left atrial volume and higher pulmonary artery pressure than those without AF. Preserved left ventricular ejection fraction (≥50%) was found in 86% of the participants, mid-range ejection fraction (40%-49%) in 3.2% and reduced ejection fraction (<40%) in 10.8%. Thirteen patients (14%) had other serious cardiac disorders that required medical attention. Conclusion Elderly individuals with NT-proBNP levels ≥900 ng/L constitute a population at high cardiovascular risk even in the absence of diagnosed CHF or AF, and therefore merit further investigation.",2020,The NT-proBNP value in this group was not significantly different from those where AF was not detected (median 1285 vs 1178 ng/L).,"['All individuals aged 75/76 years in the Stockholm region', 'Elderly individuals with NT-proBNP levels ≥900\u2009ng/L constitute a population at high cardiovascular risk', 'Thirteen patients (14%) had other serious cardiac disorders that required medical attention', 'population of individuals aged 75/76 years old with NT-proBNP ≥900\u2009ng/L without previously known CHF or AF.\nMethods', '6315 participants without AF who had NT-proBNP sampled, 102 without previously known CHF had ≥900\u2009ng/L. Of these, 93 completed further clinical investigations', 'Individuals with NT-proBNP ≥900\u2009ng/L without known CHF were invited for further clinical evaluation', 'individuals aged 75/76 years old with screening-detected elevated NT-proBNP levels']",[],"['Preserved left ventricular ejection fraction', 'reduced ejection fraction', 'larger left atrial volume and higher pulmonary artery pressure', 'median NT-proBNP', 'NT-proBNP value', 'congestive heart failure (CHF) and atrial fibrillation (AF']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C1963813', 'cui_str': 'NT-proBNP'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0439297', 'cui_str': 'pg/mL'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0018799', 'cui_str': 'Cardiac Diseases'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0205309', 'cui_str': 'Known (qualifier value)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0442726', 'cui_str': 'Detected (qualifier value)'}]",[],"[{'cui': 'C0728887', 'cui_str': 'Preserving (attribute)'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction (observable entity)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0428642', 'cui_str': 'Pulmonary artery pressure (observable entity)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1963813', 'cui_str': 'NT-proBNP'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0018802', 'cui_str': 'Congestive heart failure (disorder)'}, {'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}]",6315.0,0.06399,The NT-proBNP value in this group was not significantly different from those where AF was not detected (median 1285 vs 1178 ng/L).,"[{'ForeName': 'Faris', 'Initials': 'F', 'LastName': 'Al-Khalili', 'Affiliation': 'Department of Clinical Sciences, Karolinska Institutet, Danderyd University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Katrin', 'Initials': 'K', 'LastName': 'Kemp-Gudmundsdottir', 'Affiliation': 'Department of Clinical Sciences, Karolinska Institutet, Danderyd University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Svennberg', 'Affiliation': 'Department of Clinical Sciences, Karolinska Institutet, Danderyd University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Tove', 'Initials': 'T', 'LastName': 'Fredriksson', 'Affiliation': 'Department of Clinical Sciences, Karolinska Institutet, Danderyd University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Viveka', 'Initials': 'V', 'LastName': 'Frykman', 'Affiliation': 'Department of Clinical Sciences, Karolinska Institutet, Danderyd University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Leif', 'Initials': 'L', 'LastName': 'Friberg', 'Affiliation': 'Department of Clinical Sciences, Karolinska Institutet, Danderyd University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Mårten', 'Initials': 'M', 'LastName': 'Rosenqvist', 'Affiliation': 'Department of Clinical Sciences, Karolinska Institutet, Danderyd University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Engdahl', 'Affiliation': 'Department of Clinical Sciences, Karolinska Institutet, Danderyd University Hospital, Stockholm, Sweden.'}]",Open heart,['10.1136/openhrt-2019-001200'] 605,32167131,Prospective clinical trial examining the impact of genetic variation in FADS1 on the metabolism of linoleic acid- and ɣ-linolenic acid-containing botanical oils.,"BACKGROUND Unexplained heterogeneity in clinical trials has resulted in questions regarding the effectiveness of ɣ-linolenic acid (GLA)-containing botanical oil supplements. This heterogeneity may be explained by genetic variation within the fatty acid desaturase (FADS) gene cluster that is associated with circulating and tissue concentrations of arachidonic acid (ARA) and dihomo-ɣ-linolenic acid (DGLA), both of which may be synthesized from GLA and result in proinflammatory and anti-inflammatory metabolites, respectively. OBJECTIVES The objective of this study was to prospectively compare the capacity of a non-Hispanic white cohort, stratified by FADS genotype at the key single-nucleotide polymorphism (SNP) rs174537, to metabolize 18-carbon omega-6 (n-6) PUFAs in borage oil (BO) and soybean oil (SO) to GLA, DGLA, and ARA. METHODS Healthy adults (n = 64) participated in a randomized, double-blind, crossover intervention. Individuals received encapsulated BO (Borago officinalis L.; 37% LA and 23% GLA) or SO [Glycine max (L.) Merr.; 50% LA and 0% GLA] for 4 wk, followed by an 8-wk washout period, before consuming the opposite oil for 4 wk. Serum lipids and markers of inflammation (C-reactive protein) were assessed for both oil types at baseline and during weeks 2 and 4 of the intervention. RESULTS SO supplementation failed to alter circulating concentrations of any n-6 long-chain PUFAs. In contrast, a modest daily dose of BO elevated serum concentrations of GLA and DGLA in an rs174537 genotype-dependent manner. In particular, DGLA increased by 57% (95% CI: 0.38, 0.79) in GG genotype individuals, but by 141% (95% CI: 1.03, 2.85) in TT individuals. For ARA, baseline concentrations varied substantially by genotype and increased modestly with BO supplementation, suggesting a key role for FADS variation in the balance of DGLA and ARA. CONCLUSIONS The results of this study clearly suggest that personalized and population-based approaches considering FADS genetic variation may be necessary to optimize the design of future clinical studies with GLA-containing oils. This trial was registered at clinicaltrials.gov as NCT02337231.",2020,"In particular, DGLA increased by 57% (95% CI: 0.38, 0.79) in GG genotype individuals, but by 141% (95% CI: 1.03, 2.85) in TT individuals.",['Healthy adults (n\xa0=\xa064'],"['metabolize 18-carbon omega-6', 'n-6) PUFAs in borage oil (BO) and soybean oil (SO', 'acid- and ɣ-linolenic acid-containing botanical oils', 'linoleic', 'linolenic acid (GLA)-containing botanical oil supplements', 'encapsulated BO (Borago officinalis L.; 37% LA and 23% GLA) or SO [Glycine max (L']","['DGLA', 'Serum lipids and markers of inflammation (C-reactive protein']","[{'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}]","[{'cui': 'C0007009', 'cui_str': 'Carbon-12'}, {'cui': 'C1719844', 'cui_str': 'Greek letter omega'}, {'cui': 'C0212750', 'cui_str': 'starflower oil'}, {'cui': 'C0037732', 'cui_str': 'Soybean Oil'}, {'cui': 'C0001128', 'cui_str': 'Acids'}, {'cui': 'C0125903', 'cui_str': 'Linolenic Acid'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0028908', 'cui_str': 'Oils'}, {'cui': 'C0205223', 'cui_str': 'Encapsulated (qualifier value)'}, {'cui': 'C0522464', 'cui_str': 'Borage'}, {'cui': 'C0037733', 'cui_str': 'Soy Beans'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}]",64.0,0.454568,"In particular, DGLA increased by 57% (95% CI: 0.38, 0.79) in GG genotype individuals, but by 141% (95% CI: 1.03, 2.85) in TT individuals.","[{'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Sergeant', 'Affiliation': 'Department of Biochemistry, Wake Forest School of Medicine, Winston-Salem, NC, USA.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Hallmark', 'Affiliation': 'BIO5 Institute, University of Arizona, Tucson, AZ, USA.'}, {'ForeName': 'Rasika A', 'Initials': 'RA', 'LastName': 'Mathias', 'Affiliation': 'Center for Botanical Lipids and Inflammatory Disease Prevention, Wake Forest School of Medicine,Winston-Salem, NC, USA.'}, {'ForeName': 'Tammy L', 'Initials': 'TL', 'LastName': 'Mustin', 'Affiliation': 'Center for Botanical Lipids and Inflammatory Disease Prevention, Wake Forest School of Medicine,Winston-Salem, NC, USA.'}, {'ForeName': 'Priscilla', 'Initials': 'P', 'LastName': 'Ivester', 'Affiliation': 'Center for Botanical Lipids and Inflammatory Disease Prevention, Wake Forest School of Medicine,Winston-Salem, NC, USA.'}, {'ForeName': 'Maggie L', 'Initials': 'ML', 'LastName': 'Bohannon', 'Affiliation': 'Center for Botanical Lipids and Inflammatory Disease Prevention, Wake Forest School of Medicine,Winston-Salem, NC, USA.'}, {'ForeName': 'Ingo', 'Initials': 'I', 'LastName': 'Ruczinski', 'Affiliation': 'Center for Botanical Lipids and Inflammatory Disease Prevention, Wake Forest School of Medicine,Winston-Salem, NC, USA.'}, {'ForeName': 'Laurel', 'Initials': 'L', 'LastName': 'Johnstone', 'Affiliation': 'BIO5 Institute, University of Arizona, Tucson, AZ, USA.'}, {'ForeName': 'Michael C', 'Initials': 'MC', 'LastName': 'Seeds', 'Affiliation': 'Center for Botanical Lipids and Inflammatory Disease Prevention, Wake Forest School of Medicine,Winston-Salem, NC, USA.'}, {'ForeName': 'Floyd H', 'Initials': 'FH', 'LastName': 'Chilton', 'Affiliation': 'Center for Botanical Lipids and Inflammatory Disease Prevention, Wake Forest School of Medicine,Winston-Salem, NC, USA.'}]",The American journal of clinical nutrition,['10.1093/ajcn/nqaa023'] 606,31601448,"The effect of different styles of medical illustration on information comprehension, the perception of educational material and illness beliefs.","OBJECTIVE To explore how the addition of a medical illustration and its style affected information comprehension, perception of educational material and illness beliefs. METHODS 204 people recruited in a supermarket were randomised to read one of the four leaflets about gout and fill out a questionnaire. Three leaflets had a picture showing gout in the form of a cartoon, an anatomical drawing or a computed tomography scan (CT). The control leaflet did not contain images. RESULTS Seeing an illustrated leaflet helped correctly identify treatment for gout X 2 (1, N = 204) = 5.51, p=0.019. Out of the three images, only the cartoon was better than text in conveying information about treatment X 2 (1, n = 102) = 8.84, p=0.018. Participants perceived illustrated leaflets as more visually appealing t(70) = 3.09, p = 0.003, and the anatomical image was seen as more helpful for understanding of the illness than the cartoon. Pictures did not significantly influence lay illness perceptions about gout. CONCLUSION Pictures aid the understanding of health information and increase the visual appeal of materials. While simpler illustrations convey information more effectively, people prefer more detailed anatomical images; CT scans offer no benefits over simpler images. PRACTICE IMPLICATIONS The results can help guide the use of images in gout education material.",2020,"Participants perceived illustrated leaflets as more visually appealing t(70) = 3.09, p = 0.003, and the anatomical image was seen as more helpful for understanding of the illness than the cartoon.",['204 people recruited in a supermarket'],[],['illustrated leaflets'],"[{'cui': 'C0557778', 'cui_str': 'Supermarket (environment)'}]",[],[],204.0,0.0613867,"Participants perceived illustrated leaflets as more visually appealing t(70) = 3.09, p = 0.003, and the anatomical image was seen as more helpful for understanding of the illness than the cartoon.","[{'ForeName': 'Alina', 'Initials': 'A', 'LastName': 'Krasnoryadtseva', 'Affiliation': 'Department of Psychological Medicine, University of Auckland, Auckland, New Zealand. Electronic address: a.krasnoryadtseva@auckland.ac.nz.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Dalbeth', 'Affiliation': 'Department of Medicine, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Keith J', 'Initials': 'KJ', 'LastName': 'Petrie', 'Affiliation': 'Department of Psychological Medicine, University of Auckland, Auckland, New Zealand.'}]",Patient education and counseling,['10.1016/j.pec.2019.09.026'] 607,32160096,Randomized Phase IIB Trial of Proton Beam Therapy Versus Intensity-Modulated Radiation Therapy for Locally Advanced Esophageal Cancer.,"PURPOSE Whether dosimetric advantages of proton beam therapy (PBT) translate to improved clinical outcomes compared with intensity-modulated radiation therapy (IMRT) remains unclear. This randomized trial compared total toxicity burden (TTB) and progression-free survival (PFS) between these modalities for esophageal cancer. METHODS This phase IIB trial randomly assigned patients to PBT or IMRT (50.4 Gy), stratified for histology, resectability, induction chemotherapy, and stage. The prespecified coprimary end points were TTB and PFS. TTB, a composite score of 11 distinct adverse events (AEs), including common toxicities as well as postoperative complications (POCs) in operated patients, quantified the extent of AE severity experienced over the duration of 1 year following treatment. The trial was conducted using Bayesian group sequential design with three planned interim analyses at 33%, 50%, and 67% of expected accrual (adjusted for follow-up). RESULTS This trial (commenced April 2012) was approved for closure and analysis upon activation of NRG-GI006 in March 2019, which occurred immediately prior to the planned 67% interim analysis. Altogether, 145 patients were randomly assigned (72 IMRT, 73 PBT), and 107 patients (61 IMRT, 46 PBT) were evaluable. Median follow-up was 44.1 months. Fifty-one patients (30 IMRT, 21 PBT) underwent esophagectomy; 80% of PBT was passive scattering. The posterior mean TTB was 2.3 times higher for IMRT (39.9; 95% highest posterior density interval, 26.2-54.9) than PBT (17.4; 10.5-25.0). The mean POC score was 7.6 times higher for IMRT (19.1; 7.3-32.3) versus PBT (2.5; 0.3-5.2). The posterior probability that mean TTB was lower for PBT compared with IMRT was 0.9989, which exceeded the trial's stopping boundary of 0.9942 at the 67% interim analysis. The 3-year PFS rate (50.8% v 51.2%) and 3-year overall survival rates (44.5% v 44.5%) were similar. CONCLUSION For locally advanced esophageal cancer, PBT reduced the risk and severity of AEs compared with IMRT while maintaining similar PFS.",2020,"The posterior mean TTB was 2.3 times higher for IMRT (39.9; 95% highest posterior density interval, 26.2-54.9) than PBT (17.4; 10.5-25.0).","['145 patients were randomly assigned (72 IMRT, 73 PBT), and 107 patients (61 IMRT, 46 PBT) were evaluable', 'Locally Advanced Esophageal Cancer']","['esophagectomy', 'PBT or IMRT', 'Proton Beam Therapy Versus Intensity-Modulated Radiation Therapy', 'PBT', 'IMRT', 'proton beam therapy (PBT', 'intensity-modulated radiation therapy (IMRT']","['posterior mean TTB', 'TTB and PFS', 'total toxicity burden (TTB) and progression-free survival (PFS', '3-year PFS rate', '3-year overall survival rates', 'posterior probability that mean TTB', 'mean POC score', 'TTB, a composite score of 11 distinct adverse events (AEs), including common toxicities as well as postoperative complications (POCs']","[{'cui': 'C4517577', 'cui_str': '145'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C4517529', 'cui_str': 'One hundred and seven'}, {'cui': 'C0546837', 'cui_str': 'Cancer of Esophagus'}]","[{'cui': 'C0085198', 'cui_str': 'Esophagectomy'}, {'cui': 'C0436226', 'cui_str': 'Proton Beam Radiation Therapy'}, {'cui': 'C1512814', 'cui_str': 'Radiotherapy, Intensity-Modulated'}]","[{'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205214', 'cui_str': 'Common (qualifier value)'}, {'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}]",145.0,0.283472,"The posterior mean TTB was 2.3 times higher for IMRT (39.9; 95% highest posterior density interval, 26.2-54.9) than PBT (17.4; 10.5-25.0).","[{'ForeName': 'Steven H', 'Initials': 'SH', 'LastName': 'Lin', 'Affiliation': 'Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Brian P', 'Initials': 'BP', 'LastName': 'Hobbs', 'Affiliation': 'Quantitative Health Sciences, Taussig Cancer Institute, Cleveland Clinic, Cleveland, OH.'}, {'ForeName': 'Vivek', 'Initials': 'V', 'LastName': 'Verma', 'Affiliation': 'Department of Radiation Oncology, Allegheny General Hospital, Pittsburgh, PA.'}, {'ForeName': 'Rebecca S', 'Initials': 'RS', 'LastName': 'Tidwell', 'Affiliation': 'Department of Biostatistics, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Grace L', 'Initials': 'GL', 'LastName': 'Smith', 'Affiliation': 'Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Xiudong', 'Initials': 'X', 'LastName': 'Lei', 'Affiliation': 'Department of Health Services Research, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Erin M', 'Initials': 'EM', 'LastName': 'Corsini', 'Affiliation': 'Department of Cardiovascular and Thoracic Surgery, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Mok', 'Affiliation': 'Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Xiong', 'Initials': 'X', 'LastName': 'Wei', 'Affiliation': 'Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Luyang', 'Initials': 'L', 'LastName': 'Yao', 'Affiliation': 'Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': ""Department of Radiation Oncology, Tianjin Medical University Cancer Institute and Hospital, Tianjin, People's Republic of China.""}, {'ForeName': 'Ritsuko U', 'Initials': 'RU', 'LastName': 'Komaki', 'Affiliation': 'Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Joe Y', 'Initials': 'JY', 'LastName': 'Chang', 'Affiliation': 'Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Stephen G', 'Initials': 'SG', 'LastName': 'Chun', 'Affiliation': 'Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Melenda D', 'Initials': 'MD', 'LastName': 'Jeter', 'Affiliation': 'Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Stephen G', 'Initials': 'SG', 'LastName': 'Swisher', 'Affiliation': 'Department of Cardiovascular and Thoracic Surgery, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Jaffer A', 'Initials': 'JA', 'LastName': 'Ajani', 'Affiliation': 'Department of Gastrointestinal Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Mariela', 'Initials': 'M', 'LastName': 'Blum-Murphy', 'Affiliation': 'Department of Gastrointestinal Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Ara A', 'Initials': 'AA', 'LastName': 'Vaporciyan', 'Affiliation': 'Department of Cardiovascular and Thoracic Surgery, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Reza J', 'Initials': 'RJ', 'LastName': 'Mehran', 'Affiliation': 'Department of Cardiovascular and Thoracic Surgery, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Albert C', 'Initials': 'AC', 'LastName': 'Koong', 'Affiliation': 'Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Saumil J', 'Initials': 'SJ', 'LastName': 'Gandhi', 'Affiliation': 'Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Wayne L', 'Initials': 'WL', 'LastName': 'Hofstetter', 'Affiliation': 'Department of Cardiovascular and Thoracic Surgery, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Theodore S', 'Initials': 'TS', 'LastName': 'Hong', 'Affiliation': 'Department of Radiation Oncology, Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Thomas F', 'Initials': 'TF', 'LastName': 'Delaney', 'Affiliation': 'Department of Radiation Oncology, Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Zhongxing', 'Initials': 'Z', 'LastName': 'Liao', 'Affiliation': 'Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Radhe', 'Initials': 'R', 'LastName': 'Mohan', 'Affiliation': 'Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.02503'] 608,31726485,Effects of continuous positive airway pressure on blood pressure in obstructive sleep apnea patients: The Apnea Positive Pressure Long-term Efficacy Study (APPLES).,"Obstructive sleep apnea is associated with hypertension, and short-term studies have demonstrated a modest reduction in blood pressure with continuous positive airway pressure therapy. We evaluated the effects of continuous positive airway pressure versus sham continuous positive airway pressure on blood pressure in 1,101 participants with obstructive sleep apnea from the Apnea Positive Pressure Long-term Efficacy Study, a randomized, sham-controlled double-blinded study designed to assess the impact of continuous positive airway pressure on neurocognition. Participants with apnea-hypopnea index ≥ 10 were randomly assigned to continuous positive airway pressure or sham continuous positive airway pressure. Blood pressures measured in the morning and evening at baseline, 2 months and 6 months were analysed post hoc using a mixed-model repeated-measures analysis of variance. The largest magnitude reduction was approximately 2.4 mmHg in morning systolic pressure that occurred at 2 months in the continuous positive airway pressure arm as compared with an approximate 0.5 mmHg reduction in the sham group (continuous positive airway pressure effect -1.9 mmHg, p = .008). At 6 months, the difference between groups was diminished and no longer statistically significant (continuous positive airway pressure effect -0.9 mmHg, p = .12). Sensitivity analysis with use of multiple imputation approaches to account for missing data did not change the results. Treatment with continuous positive airway pressure for obstructive sleep apnea reduces morning but not evening blood pressure in a population with well-controlled blood pressure. The effect was greater after 2 than after 6 months of treatment.",2020,"At 6 months, the difference between groups was diminished and no longer statistically significant (continuous positive airway pressure effect -0.9 ","['1,101 participants with obstructive sleep apnea from the Apnea Positive Pressure Long-term Efficacy Study', 'obstructive sleep apnea patients', 'Participants with apnea-hypopnea index\u2005≥\xa010']","['continuous positive airway pressure or sham continuous positive airway pressure', 'continuous positive airway pressure', 'continuous positive airway pressure versus sham continuous positive airway pressure']","['Blood pressures', 'morning systolic pressure', 'blood pressure', 'Obstructive sleep apnea']","[{'cui': 'C0520679', 'cui_str': 'Syndrome, Sleep Apnea, Obstructive'}, {'cui': 'C0003578', 'cui_str': 'Apnea'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2111846', 'cui_str': 'Apnea-hypopnea index'}]","[{'cui': 'C0199451', 'cui_str': 'Continuous Positive Airway Pressure'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}]","[{'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0332170', 'cui_str': 'Morning (qualifier value)'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0520679', 'cui_str': 'Syndrome, Sleep Apnea, Obstructive'}]",1101.0,0.0328835,"At 6 months, the difference between groups was diminished and no longer statistically significant (continuous positive airway pressure effect -0.9 ","[{'ForeName': 'Sogol', 'Initials': 'S', 'LastName': 'Javaheri', 'Affiliation': ""Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Gottlieb', 'Affiliation': ""Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Stuart F', 'Initials': 'SF', 'LastName': 'Quan', 'Affiliation': ""Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}]",Journal of sleep research,['10.1111/jsr.12943'] 609,32160766,Neural Insensitivity to the Effects of Hunger in Women Remitted From Anorexia Nervosa.,"OBJECTIVE Anorexia nervosa has the highest mortality rate of any psychiatric condition, yet the pathophysiology of this disorder and its primary symptom, extreme dietary restriction, remains poorly understood. In states of hunger relative to satiety, the rewarding value of food stimuli normally increases to promote eating, yet individuals with anorexia nervosa avoid food despite emaciation. This study's aim was to examine potential neural insensitivity to these effects of hunger in anorexia nervosa. METHODS At two scanning sessions scheduled 24 hours apart, one after a 16-hour fast and one after a standardized meal, 26 women who were in remission from anorexia nervosa (to avoid the confounding effects of malnutrition) and 22 matched control women received tastes of sucrose solution or ionic water while functional MRI data were acquired. Within a network of interest responsible for food valuation and transforming taste signals into motivation to eat, the authors compared groups across conditions on blood-oxygen-level-dependent (BOLD) signal and task-based functional connectivity. RESULTS Participants in the two groups had similar BOLD responses to sucrose and water tastants. A group-by-condition interaction in the ventral caudal putamen indicated that hunger had opposite effects on tastant response in the control group and the remitted anorexia nervosa group, with an increase and a decrease, respectively, in BOLD response when hungry. Hunger had a similar opposite effect on insula-to-ventral caudal putamen functional connectivity in the remitted anorexia nervosa group compared with the control group. Exploratory analyses indicated that lower caudate response to tastants when hungry was associated with higher scores on harm avoidance among participants in the remitted anorexia nervosa group. CONCLUSIONS Reduced recruitment of neural circuitry that translates taste stimulation to motivated eating behavior when hungry may facilitate food avoidance and prolonged periods of extremely restricted food intake in anorexia nervosa.",2020,"Exploratory analyses indicated that lower caudate response to tastants when hungry was associated with higher scores on harm avoidance among participants in the remitted anorexia nervosa group. ","['26 women who were in remission from anorexia nervosa (to avoid the confounding effects of malnutrition) and 22 matched control women received', 'anorexia nervosa', 'Anorexia nervosa', 'Women Remitted From Anorexia Nervosa']",['tastes of sucrose solution or ionic water while functional MRI data'],"['insula-to-ventral caudal putamen functional connectivity', 'BOLD responses to sucrose and water tastants', 'tastant response', 'blood-oxygen-level-dependent (BOLD) signal and task-based functional connectivity', 'BOLD response']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0003125', 'cui_str': 'Anorexia Nervosas'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0162429', 'cui_str': 'Malnutrition'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439600', 'cui_str': 'Remitting (qualifier value)'}]","[{'cui': 'C0039336', 'cui_str': 'Gustation'}, {'cui': 'C0038636', 'cui_str': 'Sucrose'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}, {'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C0376335', 'cui_str': 'fMRI'}]","[{'cui': 'C0021640', 'cui_str': 'Insula of Reil'}, {'cui': 'C1704448', 'cui_str': 'Ventral'}, {'cui': 'C0205097', 'cui_str': 'Caudal (qualifier value)'}, {'cui': 'C0034169', 'cui_str': 'Nucleus Putamen'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0038636', 'cui_str': 'Sucrose'}, {'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C0005768'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}, {'cui': 'C0178499', 'cui_str': 'Base'}]",26.0,0.0655501,"Exploratory analyses indicated that lower caudate response to tastants when hungry was associated with higher scores on harm avoidance among participants in the remitted anorexia nervosa group. ","[{'ForeName': 'Walter H', 'Initials': 'WH', 'LastName': 'Kaye', 'Affiliation': 'Department of Psychiatry, University of California, San Diego, San Diego (Kaye, Wierenga, Bischoff-Grethe, Berner, Ely, Bailer, Paulus); Department of Psychiatry, Icahn School of Medicine at Mount Sinai, New York (Berner); Department of Psychiatry and Psychotherapy, Division of General Psychiatry, Medical University of Vienna, Vienna (Bailer); Laureate Institute for Brain Research, Tulsa, Okla. (Paulus); Departments of Neuroscience and Psychiatry, University of Rochester Medical Center, Rochester, New York (Fudge).'}, {'ForeName': 'Christina E', 'Initials': 'CE', 'LastName': 'Wierenga', 'Affiliation': 'Department of Psychiatry, University of California, San Diego, San Diego (Kaye, Wierenga, Bischoff-Grethe, Berner, Ely, Bailer, Paulus); Department of Psychiatry, Icahn School of Medicine at Mount Sinai, New York (Berner); Department of Psychiatry and Psychotherapy, Division of General Psychiatry, Medical University of Vienna, Vienna (Bailer); Laureate Institute for Brain Research, Tulsa, Okla. (Paulus); Departments of Neuroscience and Psychiatry, University of Rochester Medical Center, Rochester, New York (Fudge).'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Bischoff-Grethe', 'Affiliation': 'Department of Psychiatry, University of California, San Diego, San Diego (Kaye, Wierenga, Bischoff-Grethe, Berner, Ely, Bailer, Paulus); Department of Psychiatry, Icahn School of Medicine at Mount Sinai, New York (Berner); Department of Psychiatry and Psychotherapy, Division of General Psychiatry, Medical University of Vienna, Vienna (Bailer); Laureate Institute for Brain Research, Tulsa, Okla. (Paulus); Departments of Neuroscience and Psychiatry, University of Rochester Medical Center, Rochester, New York (Fudge).'}, {'ForeName': 'Laura A', 'Initials': 'LA', 'LastName': 'Berner', 'Affiliation': 'Department of Psychiatry, University of California, San Diego, San Diego (Kaye, Wierenga, Bischoff-Grethe, Berner, Ely, Bailer, Paulus); Department of Psychiatry, Icahn School of Medicine at Mount Sinai, New York (Berner); Department of Psychiatry and Psychotherapy, Division of General Psychiatry, Medical University of Vienna, Vienna (Bailer); Laureate Institute for Brain Research, Tulsa, Okla. (Paulus); Departments of Neuroscience and Psychiatry, University of Rochester Medical Center, Rochester, New York (Fudge).'}, {'ForeName': 'Alice V', 'Initials': 'AV', 'LastName': 'Ely', 'Affiliation': 'Department of Psychiatry, University of California, San Diego, San Diego (Kaye, Wierenga, Bischoff-Grethe, Berner, Ely, Bailer, Paulus); Department of Psychiatry, Icahn School of Medicine at Mount Sinai, New York (Berner); Department of Psychiatry and Psychotherapy, Division of General Psychiatry, Medical University of Vienna, Vienna (Bailer); Laureate Institute for Brain Research, Tulsa, Okla. (Paulus); Departments of Neuroscience and Psychiatry, University of Rochester Medical Center, Rochester, New York (Fudge).'}, {'ForeName': 'Ursula F', 'Initials': 'UF', 'LastName': 'Bailer', 'Affiliation': 'Department of Psychiatry, University of California, San Diego, San Diego (Kaye, Wierenga, Bischoff-Grethe, Berner, Ely, Bailer, Paulus); Department of Psychiatry, Icahn School of Medicine at Mount Sinai, New York (Berner); Department of Psychiatry and Psychotherapy, Division of General Psychiatry, Medical University of Vienna, Vienna (Bailer); Laureate Institute for Brain Research, Tulsa, Okla. (Paulus); Departments of Neuroscience and Psychiatry, University of Rochester Medical Center, Rochester, New York (Fudge).'}, {'ForeName': 'Martin P', 'Initials': 'MP', 'LastName': 'Paulus', 'Affiliation': 'Department of Psychiatry, University of California, San Diego, San Diego (Kaye, Wierenga, Bischoff-Grethe, Berner, Ely, Bailer, Paulus); Department of Psychiatry, Icahn School of Medicine at Mount Sinai, New York (Berner); Department of Psychiatry and Psychotherapy, Division of General Psychiatry, Medical University of Vienna, Vienna (Bailer); Laureate Institute for Brain Research, Tulsa, Okla. (Paulus); Departments of Neuroscience and Psychiatry, University of Rochester Medical Center, Rochester, New York (Fudge).'}, {'ForeName': 'Julie L', 'Initials': 'JL', 'LastName': 'Fudge', 'Affiliation': 'Department of Psychiatry, University of California, San Diego, San Diego (Kaye, Wierenga, Bischoff-Grethe, Berner, Ely, Bailer, Paulus); Department of Psychiatry, Icahn School of Medicine at Mount Sinai, New York (Berner); Department of Psychiatry and Psychotherapy, Division of General Psychiatry, Medical University of Vienna, Vienna (Bailer); Laureate Institute for Brain Research, Tulsa, Okla. (Paulus); Departments of Neuroscience and Psychiatry, University of Rochester Medical Center, Rochester, New York (Fudge).'}]",The American journal of psychiatry,['10.1176/appi.ajp.2019.19030261'] 610,32165156,Health-related quality-of-life in children with cystic fibrosis aged 5-years and associations with health outcomes.,"BACKGROUND The impact of early cystic fibrosis (CF) on health-related quality-of-life (HRQOL) in preschool children is poorly characterised, and data on relationships between HRQOL and health outcomes in young children with CF are limited. We aimed to characterise and compare parent-proxy and child-reported HRQOL and evaluate relationships with clinical outcomes at age 5-years. METHODS Subjects were participating in the multi-centre Australasian Cystic Fibrosis Bronchoalveolar Lavage (ACFBAL) trial investigating BAL-directed versus standard CF therapy. Children aged 5-years and their parents rated HRQOL using the Pediatric Quality of Life Inventory (PedsQL™) and Cystic Fibrosis Questionnaire-Revised (CFQ-R) questionnaires. RESULTS PedsQL and CFQ-R questionnaires were completed by 141 primary caregivers and 135 and 130 children, respectively. There were no differences in HRQOL between children randomised to BAL-directed versus standard CF therapy. Children with CF rated worse HRQOL than healthy children and there was poor parent-child concordance across HRQOL domains. Nutritional status, CF-CT scan score, forced expiratory volume in 1-second (FEV 1 ), and pulmonary exacerbations correlated with HRQOL at age 5-years. FEV 1 z-scores positively correlated with parent-proxy HRQOL in CFQ-R Respiratory (p = 0.018), Physical (<0.001), Emotional (p = 0.007) subscales and PedsQL Total-score (p = 0.021), Physical (p = 0.019) domains. Pulmonary exacerbation rates were inversely associated with parent-proxy CFQ-R Respiratory (p = 0.004), Physical (p = 0.022), PedsQL Total (p = 0.009) and Physical (p = 0.009) scores. CONCLUSION Parent-reported HRQOL is a meaningful clinical endpoint to evaluate interventions in young children. Parent and child HRQOL reports provide different, complementary information. A preschool version of the CFQ-R is needed to assess relationships between HRQOL and clinical outcomes in young children.",2020,"Pulmonary exacerbation rates were inversely associated with parent-proxy CFQ-R Respiratory (p = 0.004), Physical (p = 0.022), PedsQL Total (p = 0.009) and Physical (p = 0.009) scores. ","['young children with CF', 'young children', 'children with cystic fibrosis aged 5-years and associations with health outcomes', 'preschool children', 'Subjects were participating in the multi-centre Australasian Cystic Fibrosis Bronchoalveolar Lavage (ACFBAL) trial investigating']","['BAL-directed versus standard CF therapy', 'Parent-reported HRQOL']","['HRQOL', 'Health-related quality-of-life', 'PedsQL Total-score', 'Nutritional status, CF-CT scan score, forced expiratory volume in 1-second (FEV 1 ), and pulmonary exacerbations', 'Pediatric Quality of Life Inventory (PedsQL™) and Cystic Fibrosis Questionnaire-Revised (CFQ-R) questionnaires', 'parent-proxy CFQ-R Respiratory', 'Pulmonary exacerbation rates', 'PedsQL Total', 'FEV 1 z-scores']","[{'cui': 'C0337547', 'cui_str': 'Younger child (person)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0010674', 'cui_str': 'Mucoviscidosis'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0008100', 'cui_str': 'Child, Preschool'}, {'cui': 'C3266262', 'cui_str': 'Multi'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C1535502', 'cui_str': 'Lung Lavage'}]","[{'cui': 'C0012383', 'cui_str': 'Dimercaprol'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}]","[{'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0392209', 'cui_str': 'Nutrition Status'}, {'cui': 'C0040405', 'cui_str': 'Tomography, Xray Computed'}, {'cui': 'C1306036', 'cui_str': 'Forced expiratory volume'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C4522268', 'cui_str': 'Pulmonary'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0010674', 'cui_str': 'Mucoviscidosis'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0600420', 'cui_str': 'Proxy'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}]",,0.0844049,"Pulmonary exacerbation rates were inversely associated with parent-proxy CFQ-R Respiratory (p = 0.004), Physical (p = 0.022), PedsQL Total (p = 0.009) and Physical (p = 0.009) scores. ","[{'ForeName': 'Joyce', 'Initials': 'J', 'LastName': 'Cheney', 'Affiliation': ""Department of Respiratory and Sleep Medicine, Queensland Children's Hospital, Brisbane, Australia; Centre for Children's Health Research, School of Medicine, The University of Queensland, Australia.""}, {'ForeName': 'Suzanna', 'Initials': 'S', 'LastName': 'Vidmar', 'Affiliation': ""Clinical Epidemiology and Biostatistics Unit, Murdoch Children's Research Institute, Melbourne, Australia; Department of Paediatrics, University of Melbourne, Melbourne, Australia.""}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Gailer', 'Affiliation': ""Department of Respiratory and Sleep Medicine, Queensland Children's Hospital, Brisbane, Australia.""}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Wainwright', 'Affiliation': ""Department of Respiratory and Sleep Medicine, Queensland Children's Hospital, Brisbane, Australia; Centre for Children's Health Research, School of Medicine, The University of Queensland, Australia.""}, {'ForeName': 'Tonia A', 'Initials': 'TA', 'LastName': 'Douglas', 'Affiliation': ""Department of Respiratory and Sleep Medicine, Queensland Children's Hospital, Brisbane, Australia; Centre for Children's Health Research, School of Medicine, The University of Queensland, Australia. Electronic address: tonia.douglas@health.qld.gov.au.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of cystic fibrosis : official journal of the European Cystic Fibrosis Society,['10.1016/j.jcf.2020.02.022'] 611,31961168,Sex differences in the appeal of flavored e-cigarettes among young adult e-cigarette users.,"Experimental evidence suggests that females (vs. males) may be more sensitive to and derive greater reinforcement from the sensory aspects of combustible cigarette smoking (e.g., flavor, taste). However, it is unknown if there are similar sex differences in the appeal of flavored e-cigarettes. Young adult male ( N = 65) and female ( N = 35) e-cigarette users (mean age = 25.4; 53% current smokers) attended 1 laboratory session in which they self-administered standardized e-cigarette doses according to a Flavor (fruit vs. tobacco vs. menthol) × Nicotine (6 mg/mL vs. 0 mg/mL) × Voltage (3.3 V vs. 4.3 V) within-participant fully crossed factorial design. Following each trial, participants completed ratings of appeal (mean of liking, disliking [reverse scored], and willingness-to-use-again ratings). Sex was tested as a between-subjects moderator of the effects of flavor on appeal. There was a significant interaction between sex and flavor for e-cigarette appeal ( p < .001). In males, fruit-flavored e-cigarettes generated greater appeal than menthol and tobacco ( ps < .001). In females, both fruit- and menthol-flavored e-cigarettes generated greater appeal than tobacco ( ps < .001), but there was no significant difference between fruit- and menthol-flavored e-cigarettes ( p = .40). The findings of this study suggest that males prefer fruit-flavored e-cigarettes, and females prefer both menthol- and fruit-flavored e-cigarettes. The impact of regulatory policies targeting e-cigarette flavors in the population may vary by sex. (PsycINFO Database Record (c) 2020 APA, all rights reserved).",2020,"In males, fruit-flavored e-cigarettes generated greater appeal than menthol and tobacco ( ps < .001).","['females (vs. males', 'young adult e-cigarette users', 'e-cigarette users (mean age = 25.4; 53% current smokers) attended 1', 'Young adult male ( N = 65) and female ( N = 35']","['Nicotine', 'mg/mL', 'laboratory session in which they self-administered standardized e-cigarette doses according to a Flavor (fruit vs. tobacco vs. menthol']","['ratings of appeal (mean of liking, disliking [reverse scored], and willingness-to-use-again ratings']","[{'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C4087159', 'cui_str': 'Electronic cigarette user (finding)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3241966'}, {'cui': 'C1456498', 'cui_str': 'Attended'}]","[{'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0439294', 'cui_str': 'mcg/mcL'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C3849993', 'cui_str': 'Electronic Cigarettes'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0040329', 'cui_str': 'Tobacco Products'}, {'cui': 'C0025368', 'cui_str': 'Menthol'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1947944', 'cui_str': 'Use'}]",,0.0377181,"In males, fruit-flavored e-cigarettes generated greater appeal than menthol and tobacco ( ps < .001).","[{'ForeName': 'Raina D', 'Initials': 'RD', 'LastName': 'Pang', 'Affiliation': 'Department of Preventive Medicine.'}, {'ForeName': 'Nicholas I', 'Initials': 'NI', 'LastName': 'Goldenson', 'Affiliation': 'Department of Preventive Medicine.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Kirkpatrick', 'Affiliation': 'Department of Preventive Medicine.'}, {'ForeName': 'Jessica L', 'Initials': 'JL', 'LastName': 'Barrington-Trimis', 'Affiliation': 'Department of Preventive Medicine.'}, {'ForeName': 'Junhan', 'Initials': 'J', 'LastName': 'Cho', 'Affiliation': 'Department of Preventive Medicine.'}, {'ForeName': 'Adam M', 'Initials': 'AM', 'LastName': 'Leventhal', 'Affiliation': 'Department of Preventive Medicine and Department of Psychology.'}]",Psychology of addictive behaviors : journal of the Society of Psychologists in Addictive Behaviors,['10.1037/adb0000548'] 612,31964564,"A Novel Approach to Postpartum Contraception Provision Combined with Infant Care: A Randomized, Controlled Trial.","BACKGROUND Unintended pregnancy among women with short interpregnancy intervals remains common. Women's attendance at the 4- to 6-week postpartum visit, when contraception provision often occurs, is low, whereas their attendance at well-baby visits is high. We aimed to evaluate if offering co-located contraceptive services to mothers at well-baby visits increases use of long-acting reversible contraception (LARC) at 5 months postpartum compared with usual care in a randomized, controlled trial. METHODS Women with infants aged 4.5 months or younger who were not using a LARC method and had not undergone sterilization were eligible. Generalized linear models were used to estimate risk ratios. Likability and satisfaction of the contraception visit were assessed. RESULTS Between January 2015 and January 2017, 446 women were randomized. LARC use at 5 months was 19.1% and 20.9% for the intervention and control groups, respectively, and was not significantly different after controlling for weeks postpartum (risk ratio, 0.85; 95% confidence interval, 0.59-1.23). Uptake of the co-located visit was low (17.7%), but the concept was liked; insufficient time to stay for the visit was the biggest barrier to uptake. Women who accepted the visit were more likely to use a LARC method at 5 months compared with women in the control group (risk ratio, 1.97; 95% confidence interval, 1.26-3.07). CONCLUSIONS Women perceived co-located care favorably and LARC use was higher among those who completed a visit; however, uptake was low for reasons including inability to stay after the infant visit. Intervention effects were possibly diluted. Future research should test a version of this intervention designed to overcome barriers that participants reported.",2020,"Women who accepted the visit were more likely to use a LARC method at 5 months compared with women in the control group (risk ratio, 1.97; 95% confidence interval, 1.26-3.07). ","['Between January 2015 and January 2017, 446 women were randomized', 'Women with infants aged 4.5\xa0months or younger who were not using a LARC method and had not undergone sterilization were eligible', ""Women's attendance at""]","['Combined with Infant Care', 'long-acting reversible contraception (LARC', 'Postpartum Contraception Provision']",['Likability and satisfaction of the contraception visit'],"[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3844009', 'cui_str': 'Four point five'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0445107', 'cui_str': 'Not used (qualifier value)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0362065', 'cui_str': 'Sterilization'}]","[{'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0021272', 'cui_str': 'Infant Care'}, {'cui': 'C4505307', 'cui_str': 'Long-Acting Reversible Contraception'}, {'cui': 'C0086839', 'cui_str': 'Postpartum Period'}, {'cui': 'C0700589', 'cui_str': 'Fertility Control'}]","[{'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0700589', 'cui_str': 'Fertility Control'}]",446.0,0.237738,"Women who accepted the visit were more likely to use a LARC method at 5 months compared with women in the control group (risk ratio, 1.97; 95% confidence interval, 1.26-3.07). ","[{'ForeName': 'Sadia', 'Initials': 'S', 'LastName': 'Haider', 'Affiliation': 'The University of Illinois at Chicago, Chicago, Illinois. Electronic address: shaider2@bsd.uchicago.edu.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Stoffel', 'Affiliation': 'The University of Illinois at Chicago, Chicago, Illinois.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Rankin', 'Affiliation': 'The University of Illinois at Chicago, Chicago, Illinois.'}, {'ForeName': 'Keriann', 'Initials': 'K', 'LastName': 'Uesugi', 'Affiliation': 'The University of Illinois at Chicago, Chicago, Illinois.'}, {'ForeName': 'Arden', 'Initials': 'A', 'LastName': 'Handler', 'Affiliation': 'The University of Illinois at Chicago, Chicago, Illinois.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Caskey', 'Affiliation': 'The University of Illinois at Chicago, Chicago, Illinois.'}]",Women's health issues : official publication of the Jacobs Institute of Women's Health,['10.1016/j.whi.2019.12.001'] 613,32068463,Hemodynamic and perceptual responses to blood flow-restricted exercise among patients undergoing dialysis.,"End-stage kidney disease is associated with reduced exercise capacity, muscle atrophy, and impaired muscle function. While these may be improved with exercise, single modalities of exercise do not traditionally elicit improvements across all required physiological domains. Blood flow-restricted exercise may improve all of these physiological domains with low intensities traditionally considered insufficient for these adaptions. Investigation of this technique appeals, but is yet to be evaluated, in patients undergoing dialysis. With the use of a progressive crossover design, 10 satellite patients undergoing hemodialysis underwent three exercise conditions over 2 wk: two bouts (10 min) of unrestricted cycling during two consecutive hemodialysis sessions ( condition 1 ), two bouts of cycling with blood flow restriction while off hemodialysis on 2 separate days ( condition 2 ), and two bouts of cycling with blood flow restriction during two hemodialysis sessions ( condition 3 ). Outcomes included hemodynamic responses (heart rate and blood pressure) throughout all sessions, participant-perceived exertion and discomfort on a Borg scale, and evaluation of ultrafiltration rates and dialysis adequacy (Kt/V) obtained post hoc. Hemodynamic responses were consistent regardless of condition. Significant increases in heart rate, systolic blood pressure, and mean arterial blood pressure ( P < 0.05) were observed postexercise followed by a reduction in blood pressures during the 60-min recovery (12, 5, and 11 mmHg for systolic, diastolic, and mean arterial pressures, respectively). Blood pressures returned to predialysis ranges following the recovery period. Blood flow restriction did not affect ultrafiltration achieved or Kt/V. Hemodynamic safety and tolerability of blood flow restriction during aerobic exercise on hemodialysis is comparable to standard aerobic exercise.",2020,"Significant increases in heart rate, systolic blood pressure and mean arterial blood pressure (P<0.05) were observed post-exercise, followed by a reduction in blood pressures during the 60 min recovery (12 mmHg, 5 mmHg and 11 mm Hg for systolic, diastolic and mean arterial pressures, respectively).","['Dialysis Patients', 'dialysis patients']",[],"['exercise capacity, muscle atrophy and impaired muscle function', 'blood pressures', 'haemodynamic responses (heart rate, blood pressure) throughout all sessions, participant-perceived exertion and discomfort on a Borg scale, and evaluation of ultrafiltration rates and Kt/V obtained post-hoc ', 'Blood flow restriction', 'heart rate, systolic blood pressure and mean arterial blood pressure', 'Haemodynamic and Perceptual Responses to Blood Flow', 'Blood pressures', 'Haemodynamic responses']","[{'cui': 'C4551529', 'cui_str': 'Renal Dialysis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]",[],"[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0026846', 'cui_str': 'Atrophy, Muscle'}, {'cui': 'C0231484', 'cui_str': 'Muscular activity'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0015264', 'cui_str': 'Exertion, function (observable entity)'}, {'cui': 'C2364135', 'cui_str': 'Discomfort (finding)'}, {'cui': 'C0449399', 'cui_str': 'Borg scale (assessment scale)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0041612', 'cui_str': 'Ultrafiltration'}, {'cui': 'C0429662', 'cui_str': 'kt/V (observable entity)'}, {'cui': 'C1301820', 'cui_str': 'Obtained (attribute)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow, function (observable entity)'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1272641', 'cui_str': 'Arterial Tension'}]",,0.0333491,"Significant increases in heart rate, systolic blood pressure and mean arterial blood pressure (P<0.05) were observed post-exercise, followed by a reduction in blood pressures during the 60 min recovery (12 mmHg, 5 mmHg and 11 mm Hg for systolic, diastolic and mean arterial pressures, respectively).","[{'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Clarkson', 'Affiliation': 'Institute for Physical Activity and Nutrition, School of Exercise and Nutrition Sciences, Deakin University, Geelong, Victoria, Australia.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Brumby', 'Affiliation': 'Department of Renal Medicine, Eastern Health Clinical School, Melbourne, Victoria, Australia.'}, {'ForeName': 'Steve F', 'Initials': 'SF', 'LastName': 'Fraser', 'Affiliation': 'Institute for Physical Activity and Nutrition, School of Exercise and Nutrition Sciences, Deakin University, Geelong, Victoria, Australia.'}, {'ForeName': 'Lawrence P', 'Initials': 'LP', 'LastName': 'McMahon', 'Affiliation': 'Department of Renal Medicine, Eastern Health Clinical School, Melbourne, Victoria, Australia.'}, {'ForeName': 'Paul N', 'Initials': 'PN', 'LastName': 'Bennett', 'Affiliation': 'Medical and Clinical Affairs, Satellite Healthcare, Adelaide, South Australia, Australia.'}, {'ForeName': 'Stuart A', 'Initials': 'SA', 'LastName': 'Warmington', 'Affiliation': 'Institute for Physical Activity and Nutrition, School of Exercise and Nutrition Sciences, Deakin University, Geelong, Victoria, Australia.'}]",American journal of physiology. Renal physiology,['10.1152/ajprenal.00576.2019'] 614,31638902,A four-stage process for intervention description and guide development of a practice-based intervention: refining the Namaste Care intervention implementation specification for people with advanced dementia prior to a feasibility cluster randomised trial.,"BACKGROUND Some interventions are developed from practice, and implemented before evidence of effect is determined, or the intervention is fully specified. An example is Namaste Care, a multi-component intervention for people with advanced dementia, delivered in care home, community, hospital and hospice settings. This paper describes the development of an intervention description, guide and training package to support implementation of Namaste Care within the context of a feasibility trial. This allows fidelity to be determined within the trial, and for intervention users to understand how similar their implementation is to that which was studied. METHODS A four-stage approach: a) Collating existing intervention materials and drawing from programme theory developed from a realist review to draft an intervention description. b) Exploring readability, comprehensibility and utility with staff who had not experienced Namaste Care. c) Using modified nominal group techniques with those with Namaste Care experience to refine and prioritise the intervention implementation materials. d) Final refinement with a patient and public involvement panel. RESULTS Eighteen nursing care home staff, one carer, one volunteer and five members of our public involvement panel were involved across the study steps. A 16-page A4 booklet was designed, with flow charts, graphics and colour coded information to ease navigation through the document. This was supplemented by infographics, and a training package. The guide describes the boundaries of the intervention and how to implement it, whilst retaining the flexible spirit of the Namaste Care intervention. CONCLUSIONS There is little attention paid to how best to specify complex interventions that have already been organically implemented in practice. This four-stage process may have utility for context specific adaptation or description of existing, but untested, interventions. A robust, agreed, intervention and implementation description should enable a high-quality future trial. If an effect is determined, flexible practice implementation should be enabled through having a clear, evidence-based guide.",2019,"An example is Namaste Care, a multi-component intervention for people with advanced dementia, delivered in care home, community, hospital and hospice settings.","['people with advanced dementia prior', 'people with advanced dementia', 'Eighteen nursing care home staff, one carer, one volunteer and five members of our public involvement panel were involved across the study steps']",['Namaste Care intervention implementation specification'],[],"[{'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0497327', 'cui_str': 'Amentia'}, {'cui': 'C3715206', 'cui_str': 'Eighteen'}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C2700616', 'cui_str': 'Manpowers'}, {'cui': 'C1305660', 'cui_str': 'Carer (occupation)'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0450059', 'cui_str': 'Member of public (person)'}, {'cui': 'C0205428', 'cui_str': 'Involvements (qualifier value)'}, {'cui': 'C1261552', 'cui_str': 'Step'}]",[],[],,0.0615216,"An example is Namaste Care, a multi-component intervention for people with advanced dementia, delivered in care home, community, hospital and hospice settings.","[{'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Walshe', 'Affiliation': 'International Observatory on End of Life Care, Faculty of Health and Medicine, Lancaster University, Lancaster, LA1 4YG, UK. c.walshe@lancaster.ac.uk.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Kinley', 'Affiliation': ""St Christopher's Hospice, 51-59 Lawrie Park Road, Sydenham, London, SE26 6DZ, UK.""}, {'ForeName': 'Shakil', 'Initials': 'S', 'LastName': 'Patel', 'Affiliation': 'International Observatory on End of Life Care, Faculty of Health and Medicine, Lancaster University, Lancaster, LA1 4YG, UK.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Goodman', 'Affiliation': 'Centre for Research in Public Health and Community Care, University of Hertfordshire, College Lane, Hatfield, Hertfordshire, AL10 9AB, UK.'}, {'ForeName': 'Frances', 'Initials': 'F', 'LastName': 'Bunn', 'Affiliation': 'Centre for Research in Public Health and Community Care, University of Hertfordshire, College Lane, Hatfield, Hertfordshire, AL10 9AB, UK.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Lynch', 'Affiliation': 'Centre for Research in Public Health and Community Care, University of Hertfordshire, College Lane, Hatfield, Hertfordshire, AL10 9AB, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Scott', 'Affiliation': ""Patient Representative c/o The Alzheimer's Society, London, UK.""}, {'ForeName': 'Anne Davidson', 'Initials': 'AD', 'LastName': 'Lund', 'Affiliation': ""Patient Representative c/o The Alzheimer's Society, London, UK.""}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Stacpoole', 'Affiliation': ""St Christopher's Hospice, 51-59 Lawrie Park Road, Sydenham, London, SE26 6DZ, UK.""}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Preston', 'Affiliation': 'International Observatory on End of Life Care, Faculty of Health and Medicine, Lancaster University, Lancaster, LA1 4YG, UK.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Froggatt', 'Affiliation': 'International Observatory on End of Life Care, Faculty of Health and Medicine, Lancaster University, Lancaster, LA1 4YG, UK.'}]",BMC geriatrics,['10.1186/s12877-019-1275-z'] 615,32162741,The efficacy of topical red clover oil on knee osteoarthritis: A pilot prospective randomized triple-blind placebo-controlled clinical trial.,"A triple-blind placebo-controlled clinical trial was performed to evaluate the efficacy of topical red clover oil (containing standardized red clover extract in olive oil) on knee osteoarthritis (OA). A total of 80 patients, 50-80 years old, with primary knee OA were randomly allocated to two groups. The study group used topical red clover oil and the control group used olive oil for 4 weeks (20 drops twice a day). Both groups adhered to nonpharmacological American College of Rheumatology recommendations and took meloxicam tablets during the study (0-8 weeks), and were followed up from Week 4 to 8. Efficacy measures were evaluated using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scale and Visual Analogue Scale (VAS). At baseline, both groups were homogeneous regarding demographic characteristics. In addition, they were asked about the side effects during the intervention. The results showed that the WOMAC score and its subscales of pain and stiffness and function scores and VAS significantly increased over time in both groups (p < .001). The study group showed a significant increase regarding pain (p = .001), function (p = .010), VAS (p < .001), and the WOMAC total score (p = .018). No serious drug side effects were observed. Red clover oil may have positive effects on symptoms of knee OA and can be considered as a complementary treatment.",2020,"The study group showed a significant increase regarding pain (p = .001), function (p = .010), VAS (p < .001), and the WOMAC total score (p = .018).","['knee osteoarthritis (OA', '80 patients, 50-80 years old, with primary knee OA', 'knee osteoarthritis']","['meloxicam tablets', 'topical red clover oil', 'topical red clover oil and the control group used olive oil', 'placebo', 'topical red clover oil (containing standardized red clover extract in olive oil']","['serious drug side effects', 'WOMAC score and its subscales of pain and stiffness and function scores and VAS', 'WOMAC total score', 'pain', 'Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scale and Visual Analogue Scale (VAS', 'VAS']","[{'cui': 'C0409959', 'cui_str': 'Osteoarthritis, Knee'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}]","[{'cui': 'C0083381', 'cui_str': 'meloxicam'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0330783', 'cui_str': 'Clover, Red'}, {'cui': 'C0028908', 'cui_str': 'Oils'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0069449', 'cui_str': 'olive oil'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0939844', 'cui_str': 'Red Clover Preparation'}]","[{'cui': 'C0041755', 'cui_str': 'Drug Side Effects'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C3472647', 'cui_str': 'WOMAC index'}, {'cui': 'C0222045'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}]",80.0,0.0465415,"The study group showed a significant increase regarding pain (p = .001), function (p = .010), VAS (p < .001), and the WOMAC total score (p = .018).","[{'ForeName': 'Masoud', 'Initials': 'M', 'LastName': 'Mokhtari', 'Affiliation': 'Department of Persian Medicine, School of Persian and Complementary Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Mahdi', 'Initials': 'M', 'LastName': 'Yousefi', 'Affiliation': 'Department of Persian Medicine, School of Persian and Complementary Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Mojtaba M', 'Initials': 'MM', 'LastName': 'Bazaz', 'Affiliation': 'Department of Community Medicine, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Hassan', 'Initials': 'H', 'LastName': 'Rakhshandeh', 'Affiliation': 'Pharmacological Research Center of Medicinal Plants, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Hamideh', 'Initials': 'H', 'LastName': 'Vahid', 'Affiliation': 'Department of Persian Medicine, School of Persian and Complementary Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Amir S', 'Initials': 'AS', 'LastName': 'Ariamanesh', 'Affiliation': 'Department of Orthopedics, Mashhad University of Medical Sciences, Mashhad, Iran.'}]",Phytotherapy research : PTR,['10.1002/ptr.6650'] 616,32100681,"Effect of Improved Water Quality, Sanitation, Hygiene and Nutrition Interventions on Respiratory Illness in Young Children in Rural Bangladesh: A Multi-Arm Cluster-Randomized Controlled Trial.","Acute respiratory infections cause mortality in young children. We assessed the effects of water, sanitation, hygiene (WASH) and nutritional interventions on childhood ARI. Geographic clusters of pregnant women from rural Bangladesh were randomly assigned to receive 1) chlorinated drinking water and safe storage (W); 2) upgraded sanitation (S); 3) handwashing promotion (H); 4) combined water, sanitation, and handwashing (WSH); 5) nutrition intervention including lipid-based nutrient supplements; 6) combined WSH plus nutrition (WSHN); or 7) no intervention (control). Masking of participants was not possible. Acute respiratory illness was defined as caregiver-reported persistent cough, panting, wheezing, or difficulty breathing in the past 7 days among index children, those born to enrolled women. We assessed outcomes at 12 and 24 months of intervention using intention to treat. Compared with children in the control group (ARI prevalence, P : 8.9%), caregivers of index children reported significantly lower ARI in the water ( P : 6.3%, prevalence ratio (PR): 0.71; 95% CI: 0.53, 0.96), sanitation ( P : 6.4%, PR: 0.75, 95% CI: 0.58, 0.96), handwashing ( P : 6.4%, PR: 0.68, 95% CI: 0.50, 0.93), and the combined WSH+N arms ( P : 5.9%, PR: 0.67, 95% CI: 0.50, 0.90). Those in the nutrition ( P : 7.4%, PR: 0.84, 95% CI: 0.63, 1.10) or the WSH arm ( P : 8.9%, PR: 0.99, 95% CI: 0.76, 1.28) reported similar ARI prevalence compared with control children. Single targeted water, sanitation, and hygiene interventions reduced reported respiratory illness in young children. There was no apparent respiratory health benefit from combining WASH interventions.",2020,"Those in the nutrition ( P : 7.4%, PR: 0.84, 95% CI: 0.63, 1.10) or the WSH arm ( P : 8.9%, PR: 0.99, 95% CI: 0.76, 1.28) reported similar ARI prevalence compared with control children.","['young children', 'Geographic clusters of pregnant women from rural Bangladesh', 'childhood ARI', 'Young Children in Rural Bangladesh']","['water, sanitation, hygiene (WASH) and nutritional interventions', 'Water Quality, Sanitation, Hygiene and Nutrition Interventions', '1) chlorinated drinking water and safe storage (W); 2) upgraded sanitation (S); 3) handwashing promotion (H); 4) combined water, sanitation, and handwashing (WSH); 5) nutrition intervention including lipid-based nutrient supplements; 6) combined WSH plus nutrition (WSHN); or 7) no intervention (control']","['ARI prevalence', 'Respiratory Illness', 'respiratory illness', 'Acute respiratory infection', 'ARI']","[{'cui': 'C0337547', 'cui_str': 'Younger child (person)'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0004732', 'cui_str': 'Bangladesh'}, {'cui': 'C0231335', 'cui_str': 'Childhood (finding)'}]","[{'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C0036172', 'cui_str': 'Sanitation'}, {'cui': 'C0020405', 'cui_str': 'Hygiene'}, {'cui': 'C0597680', 'cui_str': 'Water Quality'}, {'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}, {'cui': 'C0599638', 'cui_str': 'Drinking Water'}, {'cui': 'C1698986', 'cui_str': 'Storage (procedure)'}, {'cui': 'C0018581', 'cui_str': 'Hand Washing'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0678695', 'cui_str': 'Nutrients'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0221423', 'cui_str': 'Illness (finding)'}, {'cui': 'C0339901', 'cui_str': 'ARI - Acute respiratory infections'}]",,0.134988,"Those in the nutrition ( P : 7.4%, PR: 0.84, 95% CI: 0.63, 1.10) or the WSH arm ( P : 8.9%, PR: 0.99, 95% CI: 0.76, 1.28) reported similar ARI prevalence compared with control children.","[{'ForeName': 'Sania', 'Initials': 'S', 'LastName': 'Ashraf', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b), Dhaka, Bangladesh.'}, {'ForeName': 'Mahfuza', 'Initials': 'M', 'LastName': 'Islam', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b), Dhaka, Bangladesh.'}, {'ForeName': 'Leanne', 'Initials': 'L', 'LastName': 'Unicomb', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b), Dhaka, Bangladesh.'}, {'ForeName': 'Mahbubur', 'Initials': 'M', 'LastName': 'Rahman', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b), Dhaka, Bangladesh.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Winch', 'Affiliation': 'Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.'}, {'ForeName': 'Benjamin F', 'Initials': 'BF', 'LastName': 'Arnold', 'Affiliation': 'Division of Epidemiology and Biostatistics, School of Public Health, University of California Berkeley, Berkeley, California.'}, {'ForeName': 'Jade', 'Initials': 'J', 'LastName': 'Benjamin-Chung', 'Affiliation': 'Division of Epidemiology and Biostatistics, School of Public Health, University of California Berkeley, Berkeley, California.'}, {'ForeName': 'Pavani K', 'Initials': 'PK', 'LastName': 'Ram', 'Affiliation': 'School of Public Health and Health Professions, University at Buffalo, Buffalo, New York.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Colford', 'Affiliation': 'Division of Epidemiology and Biostatistics, School of Public Health, University of California Berkeley, Berkeley, California.'}, {'ForeName': 'Stephen P', 'Initials': 'SP', 'LastName': 'Luby', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b), Dhaka, Bangladesh.'}]",The American journal of tropical medicine and hygiene,['10.4269/ajtmh.19-0769'] 617,31157663,The benefit of immediate compared with deferred antiretroviral therapy on CD4+ cell count recovery in early HIV infection.,"OBJECTIVE To assess the impact of immediate vs. deferred antiretroviral therapy (ART) on CD4 recovery among individuals early in HIV infection. DESIGN Using serologic markers of early infection together with self-reported dates of infection and HIV diagnosis, ART-naive participants who were randomized to immediate vs. deferred ART in the Strategic Timing of Antiretroviral Treatment trial were classified into subgroups of duration of HIV infection at baseline. CD4 cell count recovery over follow-up according to duration of HIV infection was investigated. METHODS Three subgroups were defined: first, infected 6 months or less (n = 373); second, infected 6-24 months (n = 2634); and third, infected 24 months or longer (n = 1605). Follow-up CD4, CD8, and CD4 : CD8 ratio for the immediate and deferred ART groups were compared by subgroup using linear models. For the deferred ART group, decline to CD4 less than 350 cells/μl or AIDS according to infection duration was compared using time-to-event methods. RESULTS Follow-up CD4 cell count differences (immediate minus deferred) were greater for those recently infected (+231 cells/μl) compared with the two other subgroups (202 and 171 cells/μl; P < 0.001). CD4 : CD8 ratio treatment differences varied significantly (P < 0.001) according to duration of infection. In the deferred ART group, decline to CD4 less than 350 cells/μl or AIDS was greater among those recently infected (16.1 vs. 13.2 and 10.5 per 100 person years for those infected 6-24 and ≥24 months; P = 0.002). CONCLUSION In this randomized comparison of immediate vs. deferred ART, the CD4 cell count difference was greatest for those recently infected with HIV, emphasizing the importance of immediate ART initiation.",2019,CD4 : CD8 ratio treatment differences varied significantly (P < 0.001) according to duration of infection.,"['individuals early in HIV infection', 'early HIV infection', 'early infection together with self-reported dates of infection and HIV diagnosis, ART-naive participants', 'Three subgroups were defined: first, infected 6 months or less (n\u200a=\u200a373); second, infected 6-24 months (n\u200a=\u200a2634); and third, infected 24 months or longer (n\u200a=\u200a1605']",['immediate vs. deferred antiretroviral therapy (ART'],"['CD4 recovery', 'CD4 cell count recovery', 'CD8 ratio', 'CD4 cell count difference']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0019693', 'cui_str': 'T-Lymphotropic Virus Type III Infections, Human'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0011008', 'cui_str': 'Dates'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}]","[{'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0003826', 'cui_str': 'Arts'}]","[{'cui': 'C0243009', 'cui_str': 'CD4+ Counts'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",3.0,0.132368,CD4 : CD8 ratio treatment differences varied significantly (P < 0.001) according to duration of infection.,"[{'ForeName': 'Shweta', 'Initials': 'S', 'LastName': 'Sharma', 'Affiliation': 'Division of Biostatistics, School of Public Health, University of Minnesota, Minneapolis, Minnesota.'}, {'ForeName': 'Katherine E', 'Initials': 'KE', 'LastName': 'Schlusser', 'Affiliation': 'Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Pola', 'Initials': 'P', 'LastName': 'de la Torre', 'Affiliation': 'Cooper University Hospital, Camden, New Jersey, USA.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Tambussi', 'Affiliation': 'IRCCS Ospedale San Raffaele, Milan, Italy.'}, {'ForeName': 'Rika', 'Initials': 'R', 'LastName': 'Draenert', 'Affiliation': 'Section Clinical Infectious Diseases, Klinikum der Universität Munich, Medizinische Klinik IV, Munich, Germany.'}, {'ForeName': 'Angie N', 'Initials': 'AN', 'LastName': 'Pinto', 'Affiliation': 'The Kirby Institute, The University of New South Wales, Sydney, New South Wales, Australia.'}, {'ForeName': 'Julia A', 'Initials': 'JA', 'LastName': 'Metcalf', 'Affiliation': 'Division of Clinical Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland, USA.'}, {'ForeName': 'James D', 'Initials': 'JD', 'LastName': 'Neaton', 'Affiliation': 'Division of Biostatistics, School of Public Health, University of Minnesota, Minneapolis, Minnesota.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Laeyendecker', 'Affiliation': 'Department of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","AIDS (London, England)",['10.1097/QAD.0000000000002219'] 618,32162204,TrimetaziDine as a Performance-enhancING drug in heart failure with preserved ejection fraction (DoPING-HFpEF): rationale and design of a placebo-controlled cross-over intervention study.,"BACKGROUND Currently, no specific treatment exists for heart failure with preserved ejection fraction (HFpEF). Left ventricular (LV) relaxation during diastole is a highly energy-demanding process, while energy homeostasis is known to be compromised in HFpEF. We hypothesise that trimetazidine - a fatty acid β‑oxidation inhibitor - improves LV diastolic function in HFpEF, by altering myocardial substrate use and improving the myocardial energy status. OBJECTIVES To assess whether trimetazidine improves LV diastolic function by improving myocardial energy metabolism in HFpEF. METHODS The DoPING-HFpEF trial is a randomised, double-blind, placebo-controlled cross-over intervention trial comparing the efficacy of trimetazidine and placebo in 25 patients with stable HFpEF. The main inclusion criteria are: New York Heart Association functional class II to IV, LV ejection fraction ≥50%, and evidence of LV diastolic dysfunction. Patients are treated with one 20-mg trimetazidine tablet or placebo thrice daily (twice daily in the case of moderate renal dysfunction) for two periods of 3 months separated by a 2-week washout period. The primary endpoint is the change in pulmonary capillary wedge pressure during different intensities of exercise measured by right heart catheterisation. Our key secondary endpoint is the myocardial phosphocreatine (PCr)/ATP ratio measured by phosphorus-31 magnetic resonance spectroscopy and its relation to the primary endpoint. Exploratory endpoints are 6‑min walk distance, N-terminal pro-brain natriuretic peptide levels, and quality of life. CONCLUSION The DoPING-HFpEF is a phase-II trial that evaluates the effect of trimetazidine, a metabolic modulator, on diastolic function and myocardial energy status in HFpEF. [EU Clinical Trial Register: 2018-002170-52; NTR registration: NL7830].",2020,"The DoPING-HFpEF trial is a randomised, double-blind, placebo-controlled cross-over intervention trial comparing the efficacy of trimetazidine and placebo in 25 patients with stable HFpEF.","['heart failure with preserved ejection fraction (DoPING-HFpEF', '25\xa0patients with stable HFpEF']","['trimetazidine -\xa0a\xa0fatty acid β‑oxidation inhibitor ', 'placebo', 'TrimetaziDine', 'trimetazidine and placebo', 'trimetazidine', 'trimetazidine tablet or placebo']","['myocardial phosphocreatine (PCr)/ATP ratio', '6‑min walk distance, N-terminal pro-brain natriuretic peptide levels, and quality of life', 'LV diastolic function', 'change in pulmonary capillary wedge pressure during different intensities of exercise measured by right heart catheterisation']","[{'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0728887', 'cui_str': 'Preserving (attribute)'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}]","[{'cui': 'C0041037', 'cui_str': 'Trimetazidine'}, {'cui': 'C0015684', 'cui_str': 'Fatty Acids'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}]","[{'cui': 'C0031634', 'cui_str': 'Phosphorylcreatine'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0429886', 'cui_str': 'Walking distance (observable entity)'}, {'cui': 'C1533071', 'cui_str': 'N-terminal pro-brain natriuretic peptide measurement'}, {'cui': 'C0034380'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0086879', 'cui_str': 'Pulmonary Capillary Wedge Pressure'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0189896', 'cui_str': 'Catheterization of right heart (procedure)'}]",,0.228946,"The DoPING-HFpEF trial is a randomised, double-blind, placebo-controlled cross-over intervention trial comparing the efficacy of trimetazidine and placebo in 25 patients with stable HFpEF.","[{'ForeName': 'A A', 'Initials': 'AA', 'LastName': 'van de Bovenkamp', 'Affiliation': 'Department of Cardiology, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam Cardiovascular Sciences, Amsterdam, The Netherlands.'}, {'ForeName': 'A J', 'Initials': 'AJ', 'LastName': 'Bakermans', 'Affiliation': 'Department of Radiology and Nuclear Medicine, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'C P', 'Initials': 'CP', 'LastName': 'Allaart', 'Affiliation': 'Department of Cardiology, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam Cardiovascular Sciences, Amsterdam, The Netherlands.'}, {'ForeName': 'A J', 'Initials': 'AJ', 'LastName': 'Nederveen', 'Affiliation': 'Department of Radiology and Nuclear Medicine, Amsterdam UMC, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'W E M', 'Initials': 'WEM', 'LastName': 'Kok', 'Affiliation': 'Department of Clinical and Experimental Cardiology, Amsterdam UMC, University of Amsterdam, Amsterdam Cardiovascular Sciences, Heart Center, Amsterdam, The Netherlands.'}, {'ForeName': 'A C', 'Initials': 'AC', 'LastName': 'van Rossum', 'Affiliation': 'Department of Cardiology, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam Cardiovascular Sciences, Amsterdam, The Netherlands.'}, {'ForeName': 'M L', 'Initials': 'ML', 'LastName': 'Handoko', 'Affiliation': 'Department of Cardiology, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam Cardiovascular Sciences, Amsterdam, The Netherlands. ml.handoko@amsterdamumc.nl.'}]",Netherlands heart journal : monthly journal of the Netherlands Society of Cardiology and the Netherlands Heart Foundation,['10.1007/s12471-020-01407-z'] 619,32031888,Virtual Reality-Based Cognitive Stimulation to Improve Cognitive Functioning in Community Elderly: A Controlled Study.,"The advantages of using naturalistic virtual reality (VR) environments based on everyday life tasks for cognitive intervention in the elderly are not yet well understood. The literature suggests that the similarity of such exercises with real life activities may improve generalizability by extending the transfer of gains of training to everyday living. This study aimed to investigate the gains associated with this ecologically-oriented virtual reality cognitive stimulation (VR-CS) versus standard cognitive stimulation in the elderly. Forty-three healthy older adults were divided into two groups: an experimental group underwent a VR-based cognitive stimulation and an active control group underwent a paper-and-pencil cognitive stimulation. The outcomes assessed at the pre-treatment and posttreatment assessment consisted in well-established tests for cognitive and executive functioning, depression, subjective well-being, and functionality. The results showed positive outcomes on dimensions of general cognition, executive functioning, attention, and visual memory in the group that underwent VR-CS. Improvements in executive functioning in this group was supported by consistent evidence of increases in attention abilities but little evidence of increases in memory abilities. Both effects may have contributed to improvements in general cognition. Further studies are needed to test whether these effects may extend to well-being and functionality in cognitively impaired older adults.",2020,"The results showed positive outcomes on dimensions of general cognition, executive functioning, attention, and visual memory in the group that underwent VR-CS.","['Forty-three healthy older adults', 'cognitively impaired older adults', 'elderly', 'Community Elderly']","['Virtual Reality-Based Cognitive Stimulation', 'standard cognitive stimulation', 'naturalistic virtual reality (VR) environments', 'VR-based cognitive stimulation and an active control group underwent a paper-and-pencil cognitive stimulation', 'virtual reality cognitive stimulation (VR-CS']","['Cognitive Functioning', 'dimensions of general cognition, executive functioning, attention, and visual memory', 'memory abilities', 'well-established tests for cognitive and executive functioning, depression, subjective well-being, and functionality', 'executive functioning', 'attention abilities']","[{'cui': 'C0450368', 'cui_str': '43 (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0221099', 'cui_str': 'Impaired (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0009462', 'cui_str': 'Community'}]","[{'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0150174', 'cui_str': 'Cognitive stimulation (regime/therapy)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0030351', 'cui_str': 'Paper'}, {'cui': 'C0441059', 'cui_str': 'Pencil (physical object)'}]","[{'cui': 'C0439534', 'cui_str': 'Dimensions (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0542316', 'cui_str': 'Visual memory (observable entity)'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0443211', 'cui_str': 'Established (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}]",43.0,0.0182445,"The results showed positive outcomes on dimensions of general cognition, executive functioning, attention, and visual memory in the group that underwent VR-CS.","[{'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Gamito', 'Affiliation': 'HEI-Lab: Digital Human-Environment Interaction Lab, University Lusophone of Humanities and Technologies, Lisboa, Portugal.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Oliveira', 'Affiliation': 'HEI-Lab: Digital Human-Environment Interaction Lab, University Lusophone of Humanities and Technologies, Lisboa, Portugal.'}, {'ForeName': 'Catarina', 'Initials': 'C', 'LastName': 'Alves', 'Affiliation': 'Junta de Freguesia de Benfica, Lisboa, Portugal.'}, {'ForeName': 'Nuno', 'Initials': 'N', 'LastName': 'Santos', 'Affiliation': 'Junta de Freguesia de Benfica, Lisboa, Portugal.'}, {'ForeName': 'Cátia', 'Initials': 'C', 'LastName': 'Coelho', 'Affiliation': 'Junta de Freguesia de Benfica, Lisboa, Portugal.'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Brito', 'Affiliation': 'HEI-Lab: Digital Human-Environment Interaction Lab, University Lusophone of Humanities and Technologies, Lisboa, Portugal.'}]","Cyberpsychology, behavior and social networking",['10.1089/cyber.2019.0271'] 620,30606886,Impact of Comorbidities and Age on Cause-Specific Mortality in Postmenopausal Patients with Breast Cancer.,"BACKGROUND The aim was to study the impact of comorbidities and age on breast cancer mortality, taking into account competing causes of death. SUBJECTS, MATERIALS, AND METHODS Cohort analysis of Dutch and Belgian patients with postmenopausal, early hormone receptor-positive breast cancer included in the Tamoxifen and Exemestane Adjuvant Multinational (TEAM) trial between 2001 and 2006. This is a randomized controlled trial of patients who had completed local treatment with curative intent and were randomized to receive exemestane for 5 years, or sequential treatment of tamoxifen followed by exemestane for a duration of 5 years. Patients were categorized by number of comorbidities (no comorbidities, 1-2 comorbidities, and >2 comorbidities) and age (<70 years and ≥70 years). Main outcome was breast cancer mortality considering other-cause mortality as competing event; cumulative incidences were calculated using the Cumulative Incidence Competing Risk Methods, and the Fine and Gray model was used to calculate the effect of age and comorbidities for the cause-specific incidences of breast cancer death, taking into account the effect of competing causes of death. RESULTS Overall, 3,159 patients were included, of which 2,203 (69.7%) were aged <70 years and 956 (30.3%) were aged ≥70 years at diagnosis. Cumulative incidence of breast cancer mortality was higher among patients ≥70 without comorbidities (22.2%, 95% CI, 17.5-26.9) compared with patients <70 without comorbidities (15.6%, 95% CI, 13.6-17.7, reference group), multivariable subdistribution hazard ratio (sHR) 1.49 (95% CI, 1.12-1.97, p = .005) after a median follow-up of 10 years. Use of chemotherapy was lower in older patients (1%, irrespective of the number of comorbidities) compared with younger patients (50%, 44%, and 38% for patients with no, 1-2, or >2 comorbidities, p < .001). CONCLUSION Older patients without comorbidities have a higher risk of dying due to breast cancer than younger counterparts, even when taking into account higher competing mortality, while use of chemotherapy in this group was low. These findings underline the need to take into account comorbidities, age, and competing mortality in the prognosis of breast cancer for accurate decision making. IMPLICATIONS FOR PRACTICE Older patients without comorbidity are at increased risk of dying from breast cancer, despite a higher other-cause mortality. This study shows that including age and comorbidity for the assessment of breast cancer mortality and other-cause mortality is indispensable for treatment decision making in older patients. Future prognostic tools for breast cancer prognosis should incorporate these items as well as risk of toxicity of adjuvant chemotherapy to adequately predict outcomes to optimize personalized treatment for older patients with early breast cancer.",2019,"Use of chemotherapy was lower in older patients (1%, irrespective of the number of comorbidities) compared with younger patients (50%, 44%, and 38% for patients with no, 1-2, or >2 comorbidities, ","['Older patients without comorbidity', 'Cohort analysis of Dutch and Belgian patients with postmenopausal, early hormone receptor-positive breast cancer included in the Tamoxifen and Exemestane Adjuvant Multinational (TEAM) trial between 2001 and 2006', 'Postmenopausal Patients with Breast Cancer', 'older patients with early breast cancer', 'Older patients without comorbidities', '3,159 patients were included, of which 2,203 (69.7%) were aged <70 years and 956 (30.3%) were aged ≥70 years at diagnosis', 'patients who had completed local treatment with curative intent', 'Patients were categorized by number of comorbidities (no comorbidities, 1-2 comorbidities, and >2 comorbidities) and age (<70 years and ≥70 years', 'older patients']","['exemestane', 'tamoxifen followed by exemestane']","['Cumulative incidence of breast cancer mortality', 'breast cancer mortality considering other-cause mortality']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0086027', 'cui_str': 'Analysis, Cohort'}, {'cui': 'C0013331', 'cui_str': 'Dutch (ethnic group)'}, {'cui': 'C0337797', 'cui_str': 'Belgians (ethnic group)'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0019932', 'cui_str': 'Hormones'}, {'cui': 'C0597357', 'cui_str': 'Receptor (substance)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0039286', 'cui_str': 'Tamoxifen'}, {'cui': 'C0851344', 'cui_str': 'exemestane'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1276305', 'cui_str': 'Curative procedure'}, {'cui': 'C1283828', 'cui_str': 'Intentional'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}]","[{'cui': 'C0851344', 'cui_str': 'exemestane'}, {'cui': 'C0039286', 'cui_str': 'Tamoxifen'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}]",3159.0,0.0764326,"Use of chemotherapy was lower in older patients (1%, irrespective of the number of comorbidities) compared with younger patients (50%, 44%, and 38% for patients with no, 1-2, or >2 comorbidities, ","[{'ForeName': 'Marloes G M', 'Initials': 'MGM', 'LastName': 'Derks', 'Affiliation': 'Department of Surgery, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Cornelis J H', 'Initials': 'CJH', 'LastName': 'van de Velde', 'Affiliation': 'Department of Surgery, Leiden University Medical Center, Leiden, The Netherlands c.j.h.van_de_velde@lumc.nl.'}, {'ForeName': 'Daniele', 'Initials': 'D', 'LastName': 'Giardiello', 'Affiliation': 'Department of Medical Statistics, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Seynaeve', 'Affiliation': 'Department of Medical Oncology, Erasmus MC Cancer Institute, Rotterdam, The Netherlands.'}, {'ForeName': 'Hein', 'Initials': 'H', 'LastName': 'Putter', 'Affiliation': 'Department of Medical Statistics, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Johan W R', 'Initials': 'JWR', 'LastName': 'Nortier', 'Affiliation': 'Department of Medical Oncology, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Luc Y', 'Initials': 'LY', 'LastName': 'Dirix', 'Affiliation': 'Oncology Center, Sint-Augustinus, Wilrijk-Antwerp, Belgium.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Bastiaannet', 'Affiliation': 'Department of Surgery, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Johanneke E A', 'Initials': 'JEA', 'LastName': 'Portielje', 'Affiliation': 'Department of Medical Oncology, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Gerrit-Jan', 'Initials': 'GJ', 'LastName': 'Liefers', 'Affiliation': 'Department of Surgery, Leiden University Medical Center, Leiden, The Netherlands.'}]",The oncologist,['10.1634/theoncologist.2018-0010'] 621,32029306,Pharmacodynamic study of prasugrel or clopidogrel in non-ST-elevation acute coronary syndrome with CYP2C19 genetic variants undergoing percutaneous coronary intervention (PRAISE-GENE trial).,"BACKGROUND The CYP2C19*2 or *3 loss-of-function (LOF) allele is associated with high platelet reactivity (HPR) on clopidogrel treatment. East Asians may benefit from a lower dose of prasugrel due to their more potent platelet inhibitory response. The impact of LOF alleles on the pharmacodynamic response to half-dose prasugrel in patients with non-ST-elevation acute coronary syndrome (NSTE-ACS) undergoing percutaneous coronary intervention (PCI) is unknown. METHODS Seventy patients with the LOF alleles were assigned to half-dose prasugrel (n = 35, 30-mg load followed by 5 mg daily) or clopidogrel (n = 35, 600-mg load followed by 75 mg daily). The primary endpoint was the rate of HPR, defined as VerifyNow-P2Y12 reaction unit (PRU) >235, at 24 h post loading. RESULTS Prasugrel achieved a lower PRU compared to clopidogrel after loading (119 [56-175] vs. 245 [189-299]), at 24 h (34 [8-58] vs. 196 [122-244]), and at 30 days (134 [98-189] vs. 203 [144-248]). Prasugrel had a lower rate of HPR after loading (5.7% vs. 57.1%, p <0.001), at 24 h (2.9% vs. 28.6%, p=0.006), and at 30 days (11.4% vs. 34.3%, p=0.004). Prasugrel had a similar rate of optimal platelet reactivity at 30 days (71.4% vs. 60.0%, p=0.450). There was no significant difference in the occurrence of periprocedural myonecrosis within 48 h after PCI with clopidogrel and prasugrel (22.9% vs. 17.1%, p>0.960). CONCLUSIONS Half-dose prasugrel provided potent platelet inhibition in NSTE-ACS patients that were carriers of the CYP2C19*2 or *3 allele, with a lower rate of HPR. Periprocedural myonecrosis was not significantly different in the 2 groups.",2020,"There was no significant difference in the occurrence of periprocedural myonecrosis within 48 h after PCI with clopidogrel and prasugrel (22.9% vs. 17.1%, p>0.960). ","['Seventy patients with the LOF alleles', 'patients with non-ST-elevation acute coronary syndrome (NSTE-ACS) undergoing', 'non-ST-elevation acute coronary syndrome with CYP2C19 genetic variants undergoing percutaneous coronary intervention (PRAISE-GENE trial']","['CYP2C19', 'percutaneous coronary intervention (PCI', 'Prasugrel', 'clopidogrel', 'prasugrel (n\xa0=\xa035, 30-mg load followed by 5\xa0mg daily) or clopidogrel', 'prasugrel or clopidogrel']","['pharmacodynamic response', 'rate of HPR', 'rate of HPR, defined as VerifyNow-P2Y12 reaction unit (PRU', 'rate of optimal platelet reactivity', 'occurrence of periprocedural myonecrosis', 'Periprocedural myonecrosis', 'platelet inhibition', 'rate of HPR after loading']","[{'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0002085', 'cui_str': 'Allelomorphs'}, {'cui': 'C0520886', 'cui_str': 'ST segment elevation (finding)'}, {'cui': 'C0948089', 'cui_str': 'Acute Coronary Syndrome'}, {'cui': 'C3714749', 'cui_str': ""S-Mephenytoin 4'-Hydroxylase""}, {'cui': 'C0017399', 'cui_str': 'genetics'}, {'cui': 'C0205419', 'cui_str': 'Variant (qualifier value)'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}, {'cui': 'C0557963', 'cui_str': 'Praising (procedure)'}, {'cui': 'C0017337', 'cui_str': 'Genes'}]","[{'cui': 'C3714749', 'cui_str': ""S-Mephenytoin 4'-Hydroxylase""}, {'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}, {'cui': 'C1620287', 'cui_str': 'prasugrel'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}]","[{'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0443286', 'cui_str': 'Reaction (qualifier value)'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0005821', 'cui_str': 'Platelets'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0235957', 'cui_str': 'Muscle necrosis'}, {'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}]",70.0,0.0994712,"There was no significant difference in the occurrence of periprocedural myonecrosis within 48 h after PCI with clopidogrel and prasugrel (22.9% vs. 17.1%, p>0.960). ","[{'ForeName': 'Cai De', 'Initials': 'C', 'LastName': 'Jin', 'Affiliation': 'Department of Cardiology, Dong-A University Hospital, Busan, Republic of Korea; Department of Cardiology, Affiliated Hospital of Zunyi Medical University, Zunyi 563003, Guizhou, China.'}, {'ForeName': 'Moo Hyun', 'Initials': 'MH', 'LastName': 'Kim', 'Affiliation': 'Department of Cardiology, Dong-A University Hospital, Busan, Republic of Korea. Electronic address: kimmh@dau.ac.kr.'}, {'ForeName': 'Long Zhe', 'Initials': 'LZ', 'LastName': 'Guo', 'Affiliation': 'Department of Cardiology, The Fourth Affiliated Hospital of Harbin Medical University, Harbin, China.'}, {'ForeName': 'Enze', 'Initials': 'E', 'LastName': 'Jin', 'Affiliation': 'Department of Cardiology, The Fourth Affiliated Hospital of Harbin Medical University, Harbin, China.'}, {'ForeName': 'Eun-Seok', 'Initials': 'ES', 'LastName': 'Shin', 'Affiliation': 'Department of Cardiology, Ulsan University Hospital, University of Ulsan College of Medicine, Ulsan, Republic of Korea.'}, {'ForeName': 'Soe Hee', 'Initials': 'SH', 'LastName': 'Ann', 'Affiliation': 'Department of Cardiology, Ulsan University Hospital, University of Ulsan College of Medicine, Ulsan, Republic of Korea.'}, {'ForeName': 'Young-Rak', 'Initials': 'YR', 'LastName': 'Cho', 'Affiliation': 'Department of Cardiology, Dong-A University Hospital, Busan, Republic of Korea.'}, {'ForeName': 'Jong Sung', 'Initials': 'JS', 'LastName': 'Park', 'Affiliation': 'Department of Cardiology, Dong-A University Hospital, Busan, Republic of Korea.'}, {'ForeName': 'Soo Jin', 'Initials': 'SJ', 'LastName': 'Kim', 'Affiliation': 'Department of Cardiology, Dong-A University Hospital, Busan, Republic of Korea.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Lee', 'Affiliation': 'Division of Cardiology, UCLA Medical Center, Los Angeles, CA, USA.'}]",International journal of cardiology,['10.1016/j.ijcard.2020.01.058'] 622,30611638,The Effect of Shared Decisionmaking on Patients' Likelihood of Filing a Complaint or Lawsuit: A Simulation Study.,"STUDY OBJECTIVE Shared decisionmaking has been promoted as a method to increase the patient-centeredness of medical decisionmaking and decrease low-yield testing, but little is known about its medicolegal ramifications in the setting of an adverse outcome. We seek to determine whether the use of shared decisionmaking changes perceptions of fault and liability in the case of an adverse outcome. METHODS This was a randomized controlled simulation experiment conducted by survey, using clinical vignettes featuring no shared decisionmaking, brief shared decisionmaking, or thorough shared decisionmaking. Participants were adult US citizens recruited through an online crowd-sourcing platform. Participants were randomized to vignettes portraying 1 of 3 levels of shared decisionmaking. All other information given was identical, including the final clinical decision and the adverse outcome. The primary outcome was reported likelihood of pursuing legal action. Secondary outcomes included perceptions of fault, quality of care, and trust in physician. RESULTS We recruited 804 participants. Participants exposed to shared decisionmaking (brief and thorough) were 80% less likely to report a plan to contact a lawyer than those not exposed to shared decisionmaking (12% and 11% versus 41%; odds ratio 0.2; 95% confidence interval 0.12 to 0.31). Participants exposed to either level of shared decisionmaking reported higher trust, rated their physicians more highly, and were less likely to fault their physicians for the adverse outcome compared with those exposed to the no shared decisionmaking vignette. CONCLUSION In the setting of an adverse outcome from a missed diagnosis, use of shared decisionmaking may affect patients' perceptions of fault and liability.",2019,Participants exposed to shared decisionmaking (brief and thorough) were 80% less likely to report a plan to contact a lawyer than those not exposed to shared decisionmaking (12% and 11% versus 41%; odds ratio 0.2; 95% confidence interval 0.12 to 0.31).,"[""Patients' Likelihood of Filing a Complaint or Lawsuit"", 'Participants were adult US citizens recruited through an online crowd-sourcing platform', '804 participants']",['Shared Decisionmaking'],"['likelihood of pursuing legal action', 'perceptions of fault, quality of care, and trust in physician']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0180853', 'cui_str': 'File, device (physical object)'}, {'cui': 'C0277786', 'cui_str': 'Presenting complaint'}, {'cui': 'C0243118', 'cui_str': 'lawsuits'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C3494386', 'cui_str': 'Crowd Sourcing'}]",[],"[{'cui': 'C1301860', 'cui_str': 'Legal'}, {'cui': 'C0441472', 'cui_str': 'Action (qualifier value)'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0034379', 'cui_str': 'Quality of Care'}, {'cui': 'C0237935', 'cui_str': 'Trust'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}]",804.0,0.0935291,Participants exposed to shared decisionmaking (brief and thorough) were 80% less likely to report a plan to contact a lawyer than those not exposed to shared decisionmaking (12% and 11% versus 41%; odds ratio 0.2; 95% confidence interval 0.12 to 0.31).,"[{'ForeName': 'Elizabeth M', 'Initials': 'EM', 'LastName': 'Schoenfeld', 'Affiliation': 'Department of Emergency Medicine, University of Massachusetts Medical School-Baystate, Springfield, MA; Institute for Healthcare Delivery and Population Science, University of Massachusetts Medical School-Baystate, Springfield, MA. Electronic address: elizschoen@gmail.com.'}, {'ForeName': 'Shelby', 'Initials': 'S', 'LastName': 'Mader', 'Affiliation': 'Department of Emergency Medicine, University of Massachusetts Medical School-Baystate, Springfield, MA.'}, {'ForeName': 'Connor', 'Initials': 'C', 'LastName': 'Houghton', 'Affiliation': 'Department of Emergency Medicine, University of Massachusetts Medical School-Baystate, Springfield, MA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Wenger', 'Affiliation': 'Department of Emergency Medicine, University of Massachusetts Medical School-Baystate, Springfield, MA.'}, {'ForeName': 'Marc A', 'Initials': 'MA', 'LastName': 'Probst', 'Affiliation': 'Department of Emergency Medicine, Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Schoenfeld', 'Affiliation': 'Department of Biostatistics, Harvard School of Public Health, and Harvard Medical School, Boston, MA.'}, {'ForeName': 'Peter K', 'Initials': 'PK', 'LastName': 'Lindenauer', 'Affiliation': 'Institute for Healthcare Delivery and Population Science, University of Massachusetts Medical School-Baystate, Springfield, MA.'}, {'ForeName': 'Kathleen M', 'Initials': 'KM', 'LastName': 'Mazor', 'Affiliation': 'Department of Medicine, University of Massachusetts Medical School, and Meyers Primary Care Institute, Worcester, MA.'}]",Annals of emergency medicine,['10.1016/j.annemergmed.2018.11.017'] 623,32164439,"Prevalence, Symptom Burden, and Underdiagnosis of Chronic Obstructive Pulmonary Disease in a Lung Cancer Screening Cohort.","Rationale: Individuals eligible for lung cancer screening (LCS) by low-dose computed tomography (LDCT) are also at risk of chronic obstructive pulmonary disease (COPD) due to age and smoking exposure. Whether the LCS episode is useful for early detection of COPD is not well established. Objectives: To explore associations between symptoms, comorbidities, spirometry, and emphysema in participants enrolled in the Lung Screen Uptake Trial. Methods: This cross-sectional study was a prespecified analysis nested within Lung Screen Uptake Trial, which was a randomized study testing the impact of differing invitation materials on attendance of 60- to 75-year-old smokers and ex-smokers to a ""lung health check"" between November 2015 and July 2017. Participants with a smoking history ≥30 pack-years and who quit ≤15 years ago, or meeting a lung cancer risk of ≥1.51% via the Prostate Lung Colorectal Ovarian model or ≥2.5% via the Liverpool Lung Project model, were offered LDCT. COPD was defined and classified according to the GOLD (Global Initiative for Obstructive Lung Disease) criteria using prebronchodilator spirometry. Analyses included the use of descriptive statistics, chi-square tests to examine group differences, and univariable and multivariable logistic regression to explore associations between symptom prevalence, airflow limitation, and visually graded emphysema. Results: A total of 560 of 986 individuals included in the analysis (57%) had prebronchodilator spirometry consistent with COPD; 67% did not have a prior history of COPD and were termed ""undiagnosed."" Emphysema prevalence in those with known and ""undiagnosed"" COPD was 73% and 68%, respectively. A total of 32% of those with ""undiagnosed COPD"" had no emphysema on LDCT. Inhaler use and symptoms were more common in the ""known"" than the ""undiagnosed"" COPD group (63% vs. 33% with persistent cough [ P  < 0.001]; 73% vs. 33% with dyspnea [ P  < 0.001]). Comorbidities were common in all groups. Adjusted odds ratio (aOR) of respiratory symptoms were more significant for airflow obstruction (aOR GOLD 1 and 2, 1.57; confidence interval [CI], 1.14-2.17; aOR GOLD 3 and 4, 4.6; CI, 2.17-9.77) than emphysema (aOR mild, 1.12; CI, 0.81-1.55; aOR moderate, 1.33; CI, 0.85-2.09; aOR severe, 4.00; CI, 1.57-10.2). Conclusions: There is high burden of ""undiagnosed COPD"" and emphysema in LCS participants. Adding spirometry findings to the LDCT enhances identification of individuals with COPD.Clinical trial registered with www.clinicaltrials.gov (NCT02558101).",2020,"Inhaler use and symptoms were more common in the 'known' than the 'undiagnosed' COPD group (63% vs. 33% with persistent cough [p<0.001], 73% vs. 33% with dyspnoea [p<0.001]).","['560 of 986 individuals included in the analysis (57%) had pre-bronchodilator spirometry consistent with COPD', 'Individuals eligible for lung cancer screening (LCS) by low-dose', ""60-75 year-old smokers and ex-smokers to a 'lung health check' between November 2015 and July 2017"", 'individuals with COPD', 'participants enrolled in the Lung Screen Uptake Trial (LSUT', 'Participants with a smoking history ≥30 pack-years and quit ≤15 years ago, or meeting a lung cancer risk of ≥1.51% via the Prostate Lung Colorectal Ovarian (PLCOm2012) model or ≥2.5% via the Liverpool Lung Project (LLP) model, were offered LDCT']","['LDCT', 'computed tomography (LDCT']","['Emphysema prevalence', 'Prevalence, Symptom Burden and Under-Diagnosis of Chronic Obstructive Pulmonary Disease', 'symptom prevalence, airflow limitation and visually graded emphysema', 'airflow obstruction']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0006280', 'cui_str': 'Bronchodilators'}, {'cui': 'C0037981', 'cui_str': 'Spirometry'}, {'cui': 'C0332290', 'cui_str': 'Consistent with (qualifier value)'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C0281477', 'cui_str': 'Lung cancer screening (procedure)'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C4555205', 'cui_str': 'Ex-Smokers'}, {'cui': 'C0024109', 'cui_str': 'Lung'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0019665', 'cui_str': 'historical aspects'}, {'cui': 'C1277691', 'cui_str': 'Pack years'}, {'cui': 'C1306460', 'cui_str': 'Primary malignant neoplasm of lung'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0033572', 'cui_str': 'Prostate'}, {'cui': 'C0555952', 'cui_str': 'Colorectal (qualifier value)'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C1444648', 'cui_str': 'Offered'}]","[{'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}]","[{'cui': 'C0013990', 'cui_str': 'Emphysema'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C0231999', 'cui_str': 'Airflow, function (observable entity)'}, {'cui': 'C0449295', 'cui_str': 'Limitation (attribute)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}]",,0.146541,"Inhaler use and symptoms were more common in the 'known' than the 'undiagnosed' COPD group (63% vs. 33% with persistent cough [p<0.001], 73% vs. 33% with dyspnoea [p<0.001]).","[{'ForeName': 'Mamta', 'Initials': 'M', 'LastName': 'Ruparel', 'Affiliation': 'Lungs for Living Research Centre, University College London (UCL) Respiratory.'}, {'ForeName': 'Samantha L', 'Initials': 'SL', 'LastName': 'Quaife', 'Affiliation': 'Research Department of Behavioural Science and Health.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Dickson', 'Affiliation': 'Lungs for Living Research Centre, University College London (UCL) Respiratory.'}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Horst', 'Affiliation': 'Lungs for Living Research Centre, University College London (UCL) Respiratory.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Tisi', 'Affiliation': 'Lungs for Living Research Centre, University College London (UCL) Respiratory.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Hall', 'Affiliation': 'Lungs for Living Research Centre, University College London (UCL) Respiratory.'}, {'ForeName': 'Magali N', 'Initials': 'MN', 'LastName': 'Taylor', 'Affiliation': 'Department of Radiology and.'}, {'ForeName': 'Asia', 'Initials': 'A', 'LastName': 'Ahmed', 'Affiliation': 'Department of Radiology and.'}, {'ForeName': 'Penny J', 'Initials': 'PJ', 'LastName': 'Shaw', 'Affiliation': 'Department of Radiology and.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Burke', 'Affiliation': 'Department of Radiology and.'}, {'ForeName': 'May-Jan', 'Initials': 'MJ', 'LastName': 'Soo', 'Affiliation': 'Department of Radiology and.'}, {'ForeName': 'Arjun', 'Initials': 'A', 'LastName': 'Nair', 'Affiliation': 'Department of Radiology and.'}, {'ForeName': 'Anand', 'Initials': 'A', 'LastName': 'Devaraj', 'Affiliation': 'Department of Radiology, Royal Brompton Hospital, London, United Kingdom.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Sennett', 'Affiliation': 'Killick Street Health Centre, London, United Kingdom.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Hurst', 'Affiliation': 'UCL Centre for Inflammation and Repair, University College London, London, United Kingdom.'}, {'ForeName': 'Stephen W', 'Initials': 'SW', 'LastName': 'Duffy', 'Affiliation': 'Wolfson Institute of Preventive Medicine, Barts and The London School of Medicine and Dentistry, Queen Mary University, London, United Kingdom; and.'}, {'ForeName': 'Neal', 'Initials': 'N', 'LastName': 'Navani', 'Affiliation': 'Lungs for Living Research Centre, University College London (UCL) Respiratory.'}, {'ForeName': 'Angshu', 'Initials': 'A', 'LastName': 'Bhowmik', 'Affiliation': 'Department of Thoracic Medicine, Homerton University Hospital, London, United Kingdom.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Baldwin', 'Affiliation': 'Respiratory Medicine Unit, David Evans Research Centre, Nottingham University Hospitals, Nottingham, United Kingdom.'}, {'ForeName': 'Sam M', 'Initials': 'SM', 'LastName': 'Janes', 'Affiliation': 'Lungs for Living Research Centre, University College London (UCL) Respiratory.'}]",Annals of the American Thoracic Society,['10.1513/AnnalsATS.201911-857OC'] 624,31492103,Glucose-insulin-potassium improves left ventricular performances after aortic valve replacement: a secondary analysis of a randomized controlled trial.,"BACKGROUND Patients with left ventricular (LV) hypertrophy may suffer ischemia-reperfusion injuries at the time of cardiac surgery with impairment in left ventricular function. Using transesophageal echocardiography (TEE), we evaluated the impact of glucose-insulin potassium (GIK) on LV performances in patients undergoing valve replacement for aortic stenosis. METHODS In this secondary analysis of a double-blind randomized trial, moderate-to-high risk patients were assigned to receive GIK (20 IU insulin with 10 mEq KCL in 50 ml glucose 40%) or saline over 60 min upon anesthetic induction. The primary outcomes were the early changes in 2-and 3-dimensional left ventricular ejection fraction (2D and 3D-LVEF), peak global longitudinal strain (PGLS) and transmitral flow propagation velocity (Vp). RESULTS At the end of GIK infusion, LV-FAC and 2D- and 3D-LVEF were unchanged whereas Vp (mean difference [MD + 7.9%, 95% confidence interval [CI] 3.2 to 12.5%; P <  0.001) increased compared with baseline values. After Placebo infusion, there was a decrease in LV-FAC (MD -2.9%, 95%CI - 4.8 to - 1.0%), 2D-LVEF (MD -2.0%, 95%CI - 2.8 to - 1.3%, 3D-LVEF (MD -3.0%, 95%CI - 4.0 to - 2.0%) and Vp (MD - 4.5 cm/s, 95%CI - 5.6 to - 3.3 cm/s). After cardiopulmonary bypass, GIK pretreatment was associated with preserved 2D and 3D-LVEF (+ 0.4%, 95% 95%CI - 0.8 to 1.7% and + 0.4%, 95%CI - 1.3 to 2.0%), and PGLS (- 0.9, 95%CI - 1.6 to - 0.2) as well as higher Vp (+ 5.1 cm/s, 95%CI 2.9 to 7.3), compared with baseline. In contrast, in the Placebo group, 2D-LVEF (- 2.2%, 95%CI - 3.4 to - 1.0), 3D-LVEF (- 6.0%, 95%CI - 7.8 to - 4.2), and Vp (- 7.6 cm/s, 95%CI - 9.4 to - 5.9), all decreased after bypass. CONCLUSIONS Administration of GIK before aortic cross-clamping resulted in better preservation of systolic and diastolic ventricular function in patients with LV hypertrophy undergoing aortic valve replacement. TRIAL REGISTRATION ClinicalTrials.gov: NCT00788242 , registered on November 10, 2008.",2019,"At the end of GIK infusion, LV-FAC and 2D- and 3D-LVEF were unchanged whereas Vp (mean difference [MD + 7.9%, 95% confidence interval [CI] 3.2 to 12.5%; P <  0.001) increased compared with baseline values.","['aortic valve replacement', 'patients with LV hypertrophy undergoing aortic valve replacement', 'patients undergoing valve replacement for aortic stenosis', 'moderate-to-high risk patients', 'Patients with left ventricular (LV) hypertrophy may suffer ischemia-reperfusion injuries at the time of cardiac surgery with impairment in left ventricular function']","['transesophageal echocardiography (TEE', 'Placebo', 'Glucose-insulin-potassium', 'glucose-insulin potassium (GIK', 'saline', 'GIK (20\u2009IU insulin with 10\u2009mEq KCL']","['PGLS', 'systolic and diastolic ventricular function', 'LV-FAC', 'early changes in 2-and 3-dimensional left ventricular ejection fraction (2D and 3D-LVEF), peak global longitudinal strain (PGLS) and transmitral flow propagation velocity (Vp', 'LV-FAC and 2D- and 3D-LVEF', 'preserved 2D and 3D-LVEF', '2D-LVEF']","[{'cui': 'C0003506', 'cui_str': 'Replacement of aortic valve (procedure)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0149721', 'cui_str': 'Left Ventricular Hypertrophy'}, {'cui': 'C3888056', 'cui_str': 'Valve (physical object)'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0003507', 'cui_str': 'Aortic Stenosis'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0340279', 'cui_str': 'Ventricular hypertrophy (disorder)'}, {'cui': 'C0035126', 'cui_str': 'Ischemia-Reperfusion Injury'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0524727', 'cui_str': 'Surgery, Cardiac'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C0080309', 'cui_str': 'Ventricular Function'}]","[{'cui': 'C0206054', 'cui_str': 'Echocardiography, Transesophageal'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0304475', 'cui_str': 'Potassium supplement'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0439152', 'cui_str': 'milliequivalent'}]","[{'cui': 'C0136332', 'cui_str': 'PGL(a)'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0080309', 'cui_str': 'Ventricular Function'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0450363', 'cui_str': 'Three-dimensional (qualifier value)'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction (observable entity)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal (qualifier value)'}, {'cui': 'C0080194', 'cui_str': 'Strains'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C0728887', 'cui_str': 'Preserving (attribute)'}]",,0.631206,"At the end of GIK infusion, LV-FAC and 2D- and 3D-LVEF were unchanged whereas Vp (mean difference [MD + 7.9%, 95% confidence interval [CI] 3.2 to 12.5%; P <  0.001) increased compared with baseline values.","[{'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Licker', 'Affiliation': 'Department of Anesthesiology, Pharmacology and Intensive Care, University Hospital of Geneva, CH-1211, Geneva, Switzerland. marc-joseph.licker@hcuge.ch.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Diaper', 'Affiliation': 'Department of Anesthesiology, Pharmacology and Intensive Care, University Hospital of Geneva, CH-1211, Geneva, Switzerland.'}, {'ForeName': 'Tornike', 'Initials': 'T', 'LastName': 'Sologashvili', 'Affiliation': 'Division of Cardiovascular Surgery, University Hospital of Geneva, Geneva, Switzerland.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Ellenberger', 'Affiliation': 'Department of Anesthesiology, Pharmacology and Intensive Care, University Hospital of Geneva, CH-1211, Geneva, Switzerland.'}]",BMC anesthesiology,['10.1186/s12871-019-0845-0'] 625,31791370,Healthy lifestyle consultation based on traditional Chinese medicine versus routine patient education in the treatment of idiopathic sudden sensorineural hearing loss after failure of systemic therapy: study protocol for a clinical randomised trial.,"BACKGROUND Idiopathic sudden sensorineural hearing loss (ISSNHL) is a major cause of deafness. Despite the advances in systemic therapy, some cases of ISSNHL are untreated, because the exact ISSNHL aetiology is unclear. Traditional Chinese medicine (TCM) has been used to treat diseases for thousands of years and is popular and widely practiced in Asia. TCM includes guidance on a healthy lifestyle. In recent decades, the relationship between lifestyle and disease has been emphasised; an unhealthy lifestyle may lead to illnesses. Thus, this study aims to compare the efficacy of lifestyle modification based on TCM with the usual consultation of ISSNHL after failure of a 2-week systemic therapy to provide a scientific basis for clinical decisions. METHODS This study is a clinical randomised trial that involves 56 patients diagnosed with ISSNHL but who have had incomplete recovery after initial management (at least 2 weeks of routine Western medical treatment). The study is performed in accordance with the sudden hearing loss clinical guideline of the American Academy of Otolaryngology-Head and Neck Surgery, published in 2012. Participants are randomly distributed into two groups: the healthy lifestyle modification group based on TCM and the control group (1:1 ratio). Patient follow-up lasts for 3 months. The primary outcome measure is the effective rate of hearing improvement, which is defined as the proportion of patients with at least 15 dB of improvement in the average thresholds of hearing loss frequency. The secondary outcome measures are improvements in word recognition score, Tinnitus Handicap Inventory and visual analogue scale for ear blockage and dizziness. Assessments are made at baseline and after lifestyle modification for 1 and 3 months. DISCUSSION The efficacy of healthy lifestyle modification based on a TCM programme for patients with ISSNHL with incomplete recovery after failure of initial systemic therapy is determined in this trial. Positive results will provide clinical evidence on the effects of a TCM-based healthy lifestyle, which could be recommended as salvage therapy for patients with ISSNHL. TRIAL REGISTRATION Chinese Clinical Trial Registry, ChiCTR-INR-17011459. Registered on 22 May 2017.",2019,"The secondary outcome measures are improvements in word recognition score, Tinnitus Handicap Inventory and visual analogue scale for ear blockage and dizziness.","['patients with ISSNHL', 'idiopathic sudden sensorineural hearing loss after failure of systemic therapy', 'patients with ISSNHL with incomplete recovery after failure of initial systemic therapy', 'accordance with the sudden hearing loss clinical guideline of the American Academy of Otolaryngology-Head and Neck Surgery, published in 2012', '56 patients diagnosed with ISSNHL but who have had incomplete recovery after initial management (at least 2\u2009weeks of routine Western medical treatment']","['TCM programme', 'TCM', 'healthy lifestyle modification group based on TCM', 'Traditional Chinese medicine (TCM', 'Healthy lifestyle consultation based on traditional Chinese medicine versus routine patient education']","['average thresholds of hearing loss frequency', 'effective rate of hearing improvement', 'word recognition score, Tinnitus Handicap Inventory and visual analogue scale for ear blockage and dizziness']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1608429', 'cui_str': 'Idiopathic (IPAH)'}, {'cui': 'C4275242', 'cui_str': 'Sudden sensorineural hearing loss (disorder)'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205257', 'cui_str': 'Incomplete (qualifier value)'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0011057', 'cui_str': 'Hearing Loss, Sudden'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0220845', 'cui_str': 'guidelines'}, {'cui': 'C0000876', 'cui_str': 'Academies'}, {'cui': 'C0029892', 'cui_str': 'Otorhinolaryngology'}, {'cui': 'C0018670', 'cui_str': 'Head'}, {'cui': 'C0185773', 'cui_str': 'Operation on neck'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}]","[{'cui': 'C4277664', 'cui_str': 'Healthy Life Styles'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0025124', 'cui_str': 'Zhong Yi Xue'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0030688', 'cui_str': 'Education of Patients'}]","[{'cui': 'C0449864', 'cui_str': 'Threshold (property) (qualifier value)'}, {'cui': 'C1384666', 'cui_str': 'Hypoacusis'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C0018767', 'cui_str': 'Audition'}, {'cui': 'C0524637', 'cui_str': 'Recognition (Psychology)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0040264', 'cui_str': 'Ringing-Buzzing-Tinnitus'}, {'cui': 'C0018576', 'cui_str': 'Handicapped'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0013443', 'cui_str': 'Vestibulocochlear Apparatus'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}]",56.0,0.0914433,"The secondary outcome measures are improvements in word recognition score, Tinnitus Handicap Inventory and visual analogue scale for ear blockage and dizziness.","[{'ForeName': 'Ying-Ping', 'Initials': 'YP', 'LastName': 'Fei', 'Affiliation': ""Hearing Center/Hearing and Speech Science Laboratory, Department of Otolaryngology Head and Neck Surgery, West China Hospital of Sichuan University, Chengdu, People's Republic of China.""}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Zheng', 'Affiliation': ""Hearing Center/Hearing and Speech Science Laboratory, Department of Otolaryngology Head and Neck Surgery, West China Hospital of Sichuan University, Chengdu, People's Republic of China. 1141679315@qq.com.""}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Lai', 'Affiliation': ""Department of Otolaryngology Head and Neck Surgery, The Affiliated Hospital of Southwest Medical University, 25 Taiping street, Jiangyang District, Luzhou, Sichuan, 646000, People's Republic of China.""}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Zhong', 'Affiliation': ""Hearing Center/Hearing and Speech Science Laboratory, Department of Otolaryngology Head and Neck Surgery, West China Hospital of Sichuan University, Chengdu, People's Republic of China.""}, {'ForeName': 'Jing-Zhe', 'Initials': 'JZ', 'LastName': 'Lu', 'Affiliation': ""Hearing Center/Hearing and Speech Science Laboratory, Department of Otolaryngology Head and Neck Surgery, West China Hospital of Sichuan University, Chengdu, People's Republic of China.""}, {'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Li', 'Affiliation': ""Hearing Center/Hearing and Speech Science Laboratory, Department of Otolaryngology Head and Neck Surgery, West China Hospital of Sichuan University, Chengdu, People's Republic of China.""}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Liu', 'Affiliation': ""Department of Otolaryngology Head and Neck Surgery, The First Affiliated Hospital of Guangzhou University of Chinese Medicine, No. 16 Yard, Airport Road, Guangzhou, 510405, People's Republic of China.""}]",Trials,['10.1186/s13063-019-3733-5'] 626,31521119,"Sub-hypnotic dose of propofol as antiemetic prophylaxis attenuates intrathecal morphine-induced postoperative nausea and vomiting, and pruritus in parturient undergoing cesarean section - a randomized control trial.","BACKGROUND Postoperative Nausea and Vomiting (PONV) is a dreadful and uncomfortable experience that significantly detracts patients' quality of life after surgery. This study aimed to examine the antiemetic effect of a single sub-hypnotic dose of propofol as prophylaxis for PONV. METHOD In this prospective, double-blind, randomized control trial, 345 parturients presented for elective cesarean section at the Obstetric unit of Tamale Teaching Hospital were recruited. Each recruited parturient was randomly assigned to one of three groups; Propofol group (n = 115) represented those who received propofol 0.5 mg/kg, Metoclopramide group (n = 115) represented those who received metoclopramide 10 mg and, Control group (n = 115) represented those who received 0.9% saline. Spinal anesthesia with 0.5% hyperbaric bupivacaine 7.5-10 mg, and intrathecal morphine 0.2 mg was employed for the anesthesia. RESULTS The data indicate that 108 (93.9%) parturients from the control group, 10 (8.7%) from the propofol group and 8 (7.0%) from the metoclopramide group experienced some incidence of PONV. There was no significant difference in the incidence of PONV (nausea, vomiting, and none) between the propofol and the metoclopramide groups (P = 0.99; 0.31; and 0.35 respectively). Parturients who received antiemetic agents were 105 (97.2%), 1 (10.0%) and 3 (37.5%) from the control, propofol and metoclopramide groups respectively. The data indicated that 98 (85.2%) parturients from the control, 3 (2.6%) from propofol group, and 100 (87.0%) from the metoclopramide group experienced some levels of pruritus. There was a significant difference in the incidence of pruritus (mild, moderate, and no pruritus) between the metoclopramide and propofol groups (P <  0.01; P <  0.01; and P <  0.01 respectively). CONCLUSION A sub-hypnotic dose of propofol is effective as metoclopramide in the prevention of PONV in parturient undergoing cesarean section under spinal anesthesia with intrathecal morphine. Sub-hypnotic dose of propofol significantly reduces the incidence of postoperative pruritus following intrathecal morphine use. TRIAL REGISTRATION Current control trial, registered at ISRCTN trial registry: ISRCTN15475205 . Date registered: 03/04/2019. Retrospectively registered.",2019,"Sub-hypnotic dose of propofol significantly reduces the incidence of postoperative pruritus following intrathecal morphine use. ","['345 parturients presented for elective cesarean section at the Obstetric unit of Tamale Teaching Hospital were recruited', 'parturient undergoing cesarean section under spinal anesthesia with intrathecal morphine', 'parturient undergoing cesarean section ']","['intrathecal morphine', 'metoclopramide 10\u2009mg and, Control group (n\u2009=\u2009115) represented those who received 0.9% saline', 'propofol 0.5\u2009mg/kg, Metoclopramide', 'Spinal anesthesia with 0.5% hyperbaric bupivacaine', 'propofol', 'metoclopramide', 'Propofol', 'propofol and metoclopramide']","['incidence of PONV (nausea, vomiting, and none', 'incidence of PONV', 'postoperative nausea and vomiting, and pruritus', 'levels of pruritus', 'postoperative pruritus', 'antiemetic effect', 'incidence of pruritus (mild, moderate, and no pruritus']","[{'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0473296', 'cui_str': 'Elective cesarean section'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0020027', 'cui_str': 'Teaching Hospitals'}, {'cui': 'C0007876', 'cui_str': 'C-Section (OB)'}, {'cui': 'C0002928', 'cui_str': 'Spinal Anesthesia'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}]","[{'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C1123382', 'cui_str': 'Metoclopramide 10 MG'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4517540', 'cui_str': '115 (qualifier value)'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0025853', 'cui_str': 'Metoclopramide'}, {'cui': 'C0002928', 'cui_str': 'Spinal Anesthesia'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0520909', 'cui_str': 'PONV'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0033774', 'cui_str': 'Pruritis'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C1516011', 'cui_str': 'Anti-Emetic Effects'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}]",,0.213651,"Sub-hypnotic dose of propofol significantly reduces the incidence of postoperative pruritus following intrathecal morphine use. ","[{'ForeName': 'Sylvanus', 'Initials': 'S', 'LastName': 'Kampo', 'Affiliation': 'Department of Anesthesia and Intensive Care, School of Medicine and Health Science, University for Development Studies, Tamale, Ghana. sylvanuskampo@yahoo.com.'}, {'ForeName': 'Alfred Parker', 'Initials': 'AP', 'LastName': 'Afful', 'Affiliation': 'Department of Anesthesia and Intensive Care, School of Medicine and Health Science, University for Development Studies, Tamale, Ghana.'}, {'ForeName': 'Shiraj', 'Initials': 'S', 'LastName': 'Mohammed', 'Affiliation': 'Department of Anesthesia, Tamale Teaching Hospital, Tamale, Ghana.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Ntim', 'Affiliation': 'Department of Physiology, Dalian Medical University, Dalian, China.'}, {'ForeName': 'Alexis D B', 'Initials': 'ADB', 'LastName': 'Buunaaim', 'Affiliation': 'Department of Surgery, School of Medicine and Health Science, University for Development Studies, Tamale, Ghana.'}, {'ForeName': 'Thomas Winsum', 'Initials': 'TW', 'LastName': 'Anabah', 'Affiliation': 'Department of Anesthesia and Intensive Care, School of Medicine and Health Science, University for Development Studies, Tamale, Ghana.'}]",BMC anesthesiology,['10.1186/s12871-019-0847-y'] 627,31281061,Blood eosinophils and treatment response with triple and dual combination therapy in chronic obstructive pulmonary disease: analysis of the IMPACT trial.,"BACKGROUND Previous studies have highlighted a relationship between reduction in rate of exacerbations with therapies containing inhaled corticosteroids (ICS) and baseline blood eosinophil count in patients with chronic obstructive pulmonary disease (COPD). The IMPACT trial showed that once-daily single-inhaler triple therapy significantly reduced exacerbations versus dual therapies. Blood eosinophil counts and smoking status could be important modifiers of treatment response to ICS. We aimed to model these relationships and their interactions, including outcomes other than exacerbations. METHODS IMPACT was a phase 3, randomised, double-blind, parallel-group, 52-week global study comparing once-daily single-inhaler triple therapy (fluticasone furoate-umeclidinium-vilanterol) with dual inhaled therapy (fluticasone furoate-vilanterol or umeclidinium-vilanterol). Eligible patients had moderate-to-very-severe COPD and at least one moderate or severe exacerbation in the previous year. We used fractional polynomials to model continuous blood eosinophil counts. We used negative binomial regression for numbers of moderate and severe exacerbations, severe exacerbations, and pneumonia. We modelled differences at week 52 in trough FEV 1 , St George's Respiratory Questionnaire (SGRQ) total score, and Transition Dyspnoea Index using repeated measurements mixed effect models. IMPACT was registered with ClinicalTrials.gov, number NCT02164513. FINDINGS The magnitude of benefit of regimens containing ICS (fluticasone furoate-umeclidinium-vilanterol n=4151 and fluticasone furoate-vilanterol n=4134) in reducing rates of moderate and severe exacerbations increased in proportion with blood eosinophil count, compared with a non-ICS dual long-acting bronchodilator (umeclidinium-vilanterol n=2070). The moderate and severe exacerbation rate ratio for triple therapy versus umeclidinium-vilanterol was 0·88 (95% CI 0·74 to 1·04) at blood eosinophil count less than 90 cells per μL and 0·56 (0·47 to 0·66) at counts of 310 cells per μL or more; the corresponding rate ratio for fluticasone furoate-vilanterol versus umeclidinium-vilanterol was 1·09 (0·91 to 1·29) and 0·56 (0·47 to 0·66), respectively. Similar results were observed for FEV 1 , Transition Dyspnoea Index, and SGRQ total score; however, the relationship with FEV 1 was less marked. At blood eosinophil counts less than 90 cells per μL and at counts of 310 cells per μL or more, the triple therapy versus umeclidinium-vilanterol treatment difference was 40 mL (95% CI 10 to 70) and 60 mL (20 to 100) for trough FEV 1 , -0·01 (-0·68 to 0·66) and 0·30 (-0·37 to 0·97) for Transition Dyspnoea Index score, and -0·01 (-1·81 to 1·78) and -2·78 (-4·64 to -0·92) for SGRQ total score, respectively. Smoking status modified the relationship between observed efficacy and blood eosinophil count for moderate or severe exacerbations, Transition Dyspnoea Index, and FEV 1 , with former smokers being more corticosteroid responsive at any eosinophil count than current smokers. INTERPRETATION This analysis of the IMPACT trial shows that assessment of blood eosinophil count and smoking status has the potential to optimise ICS use in clinical practice in patients with COPD and a history of exacerbations. FUNDING GlaxoSmithKline.",2019,"Smoking status modified the relationship between observed efficacy and blood eosinophil count for moderate or severe exacerbations, Transition Dyspnoea Index, and FEV 1 , with former smokers being more corticosteroid responsive at any eosinophil count than current smokers. ","['chronic obstructive pulmonary disease', 'patients with chronic obstructive pulmonary disease (COPD', 'patients with COPD and a history of exacerbations', 'Eligible patients had moderate-to-very-severe COPD and at least one moderate or severe exacerbation in the previous year']","['ICS (fluticasone furoate-umeclidinium-vilanterol n=4151 and fluticasone furoate-vilanterol n=4134', 'inhaled corticosteroids (ICS', 'triple and dual combination therapy', 'daily single-inhaler triple therapy (fluticasone furoate-umeclidinium-vilanterol) with dual inhaled therapy (fluticasone furoate-vilanterol or umeclidinium-vilanterol']","['FEV 1 , Transition Dyspnoea Index, and SGRQ total score', 'rates of moderate and severe exacerbations', 'Transition Dyspnoea Index score, and -0·01', 'Blood eosinophil counts and smoking status', ""trough FEV 1 , St George's Respiratory Questionnaire (SGRQ) total score, and Transition Dyspnoea Index"", 'moderate and severe exacerbation rate ratio']","[{'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C3641272', 'cui_str': 'Extreme'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C1948374', 'cui_str': 'fluticasone furoate'}, {'cui': 'C3661274', 'cui_str': 'umeclidinium'}, {'cui': 'C2935023', 'cui_str': 'vilanterol'}, {'cui': 'C0004048', 'cui_str': 'Inhalation'}, {'cui': 'C0205174', 'cui_str': 'Triple (qualifier value)'}, {'cui': 'C0556895', 'cui_str': 'Combination therapy (regime/therapy)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0021461', 'cui_str': 'Inhalators'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0013404', 'cui_str': 'Breathlessness'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0014467', 'cui_str': 'Eosinophil, segmented (cell)'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0444506', 'cui_str': 'Trough (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",,0.266631,"Smoking status modified the relationship between observed efficacy and blood eosinophil count for moderate or severe exacerbations, Transition Dyspnoea Index, and FEV 1 , with former smokers being more corticosteroid responsive at any eosinophil count than current smokers. ","[{'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Pascoe', 'Affiliation': 'GlaxoSmithKline, Collegeville, PA, USA. Electronic address: pascoesteve@yahoo.co.uk.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Barnes', 'Affiliation': 'GlaxoSmithKline, Brentford, UK; Barts and the London School of Medicine and Dentistry, London, UK.'}, {'ForeName': 'Guy', 'Initials': 'G', 'LastName': 'Brusselle', 'Affiliation': 'Ghent University Hospital, Ghent, Belgium.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Compton', 'Affiliation': 'GlaxoSmithKline, Brentford, UK.'}, {'ForeName': 'Gerard J', 'Initials': 'GJ', 'LastName': 'Criner', 'Affiliation': 'Lewis Katz School of Medicine at Temple University, Philadelphia, PA, USA.'}, {'ForeName': 'Mark T', 'Initials': 'MT', 'LastName': 'Dransfield', 'Affiliation': 'Division of Pulmonary, Allergy, and Critical Care Medicine, Lung Health Center, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'David M G', 'Initials': 'DMG', 'LastName': 'Halpin', 'Affiliation': 'University of Exeter Medical School, College of Medicine and Health, University of Exeter, Exeter, UK.'}, {'ForeName': 'MeiLan K', 'Initials': 'MK', 'LastName': 'Han', 'Affiliation': 'University of Michigan, Pulmonary & Critical Care, Ann Arbor, MI, USA.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Hartley', 'Affiliation': 'Statistics and Programming, Veramed Ltd, Twickenham, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Lange', 'Affiliation': 'Department of Public Health, Section of Epidemiology, University of Copenhagen, Copenhagen, Denmark; Medical Department, Herlev and Gentofte Hospital, Herlev, Denmark.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Lettis', 'Affiliation': 'GlaxoSmithKline, Uxbridge, UK.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Lipson', 'Affiliation': 'GlaxoSmithKline, Collegeville, PA, USA; Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Lomas', 'Affiliation': 'UCL Respiratory, University College London, Gower Street, London, UK.'}, {'ForeName': 'Fernando J', 'Initials': 'FJ', 'LastName': 'Martinez', 'Affiliation': 'New York-Presbyterian Weill Cornell Medical Center, New York, NY, USA.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Papi', 'Affiliation': 'Research Centre on Asthma and COPD, Department of Medical Sciences, University of Ferrara, Ferrara, Italy.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Roche', 'Affiliation': 'Pneumologie, Cochin Hospital AP-HP, University Paris Descartes, Paris, France.'}, {'ForeName': 'Ralf J P', 'Initials': 'RJP', 'LastName': 'van der Valk', 'Affiliation': 'GlaxoSmithKline, Brentford, UK.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Wise', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Johns Hopkins Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Dave', 'Initials': 'D', 'LastName': 'Singh', 'Affiliation': 'University of Manchester, Manchester, UK.'}]",The Lancet. Respiratory medicine,['10.1016/S2213-2600(19)30190-0'] 628,31487627,Quantifying adherence to antihypertensive medication for chronic hypertension during pregnancy.,Estimates of adherence to antihypertensive treatment in pregnancy are limited; identifying non-adherence could facilitate intervention and optimise blood pressure control. This study aimed to evaluate adherence to antihypertensive treatment amongst pregnant women with chronic hypertension using high-performance liquid chromatography-tandem mass spectrometry instrumentation. Spot urine samples collected from women who were randomised to labetalol or nifedipine were assessed. Samples from 74 women were included; documented prescribing and urine metabolite detection were concordant in 88% (n = 65). Evidence of self-administration of alternative treatment was observed in 8% (n = 6). Measurement of urinary antihypertensive metabolites in pregnancy provides insight into treatment adherence.,2019,Samples from 74 women were included; documented prescribing and urine metabolite detection were concordant in 88% (n = 65).,"['Spot urine samples collected from women who were randomised to', 'pregnant women with chronic hypertension using high-performance liquid chromatography-tandem mass spectrometry instrumentation', 'chronic hypertension during pregnancy', '74 women were included; documented']","['labetalol or nifedipine', 'antihypertensive medication']",['prescribing and urine metabolite detection'],"[{'cui': 'C0457208', 'cui_str': 'Spot urine sample (specimen)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0008562', 'cui_str': 'Chromatography, High Speed Liquid'}, {'cui': 'C0599748', 'cui_str': 'Mass Spectrometry-Mass Spectrometry'}, {'cui': 'C0021632', 'cui_str': 'instrumentation'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1301725', 'cui_str': 'Documented'}]","[{'cui': 'C0022860', 'cui_str': 'Labetalol'}, {'cui': 'C0028066', 'cui_str': 'Nifedipine'}, {'cui': 'C0003364', 'cui_str': 'Anti-Hypertensive Drugs'}]","[{'cui': 'C0042037'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}]",74.0,0.0733943,Samples from 74 women were included; documented prescribing and urine metabolite detection were concordant in 88% (n = 65).,"[{'ForeName': 'Louise M', 'Initials': 'LM', 'LastName': 'Webster', 'Affiliation': ""Department of Women and Children's Health, King's College London, St Thomas' Hospital, London SE1 7EH, UK. Electronic address: louise.m.webster@kcl.ac.uk.""}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Reed', 'Affiliation': ""Department of Women and Children's Health, King's College London, St Thomas' Hospital, London SE1 7EH, UK.""}, {'ForeName': 'Jenny E', 'Initials': 'JE', 'LastName': 'Myers', 'Affiliation': ""Maternal and Fetal Health Research Centre, Division of Developmental Biology and Medicine, School of Medical Sciences, University of Manchester, Manchester Academic Health Science Centre, Oxford Rd, Manchester M13 0JH, UK; St Mary's Hospital, Central Manchester Foundation Trust, Manchester M13 9PL, UK.""}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Burns', 'Affiliation': ""St Mary's Hospital, Central Manchester Foundation Trust, Manchester M13 9PL, UK.""}, {'ForeName': 'Pankaj', 'Initials': 'P', 'LastName': 'Gupta', 'Affiliation': ""St Mary's Hospital, Central Manchester Foundation Trust, Manchester M13 9PL, UK.""}, {'ForeName': 'Prashnath', 'Initials': 'P', 'LastName': 'Patel', 'Affiliation': ""St Mary's Hospital, Central Manchester Foundation Trust, Manchester M13 9PL, UK.""}, {'ForeName': 'Cornelia', 'Initials': 'C', 'LastName': 'Wiesender', 'Affiliation': ""St Mary's Hospital, Central Manchester Foundation Trust, Manchester M13 9PL, UK.""}, {'ForeName': 'Paul T', 'Initials': 'PT', 'LastName': 'Seed', 'Affiliation': ""Department of Women and Children's Health, King's College London, St Thomas' Hospital, London SE1 7EH, UK.""}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Nelson-Piercy', 'Affiliation': ""Department of Women and Children's Health, King's College London, St Thomas' Hospital, London SE1 7EH, UK.""}, {'ForeName': 'Lucy C', 'Initials': 'LC', 'LastName': 'Chappell', 'Affiliation': ""Department of Women and Children's Health, King's College London, St Thomas' Hospital, London SE1 7EH, UK; University Hospitals of Leicester NHS Trust, Leicester LE1 5WW, UK.""}]",Pregnancy hypertension,['10.1016/j.preghy.2019.05.004'] 629,31132088,"Development of a Videoconference-Adapted Version of the Community Diabetes Prevention Program, and Comparison of Weight Loss With In-Person Program Delivery.","INTRODUCTION Effective, standardized, and easily accessible weight management programs are urgently needed for military beneficiaries. Videoconference interventions have the potential for widespread scaling, and can provide both real time interaction and flexibility in delivery times regardless of location, but there is little information on their effectiveness and acceptability. MATERIALS AND METHODS This study as part of a larger weight loss trial describes the videoconference adaption of Group Lifestyle Balance (GLB) program, a community group-based Diabetes Prevention Program intervention, and provides a comparison of weight loss and meeting attendance between in-person and videoconference delivery modes over 12 weeks in adult family members of military service members. Forty-three participants were enrolled from two military installations and received either the videoconference-adapted or an in-person GLB program in a non-randomized trial design. Differences in program attendance and percent weight lost at 12 weeks were compared by independent samples t-tests and nonparametric methods. Group differences in the percentage of weight lost over the 12-week period were analyzed using a linear mixed model. RESULTS All GLB intervention components were successfully delivered by videoconference with minor adaptations for the different delivery mechanism. Participant retention was 70% and 96% in the in-person and videoconference groups, respectively (p = 0.04). Completing participants in both groups lost a significant percent body weight over the 12 week intervention (p < 0.001) and there was no difference in percent body weight after 12 weeks of intervention (6.2 ± 3.2% and 5.3 ± 3.4% for in-person and videoconference at 12 weeks, respectively; p = 0.60). CONCLUSION This study describes the first videoconference adaption of the GLB program for use in military families. Attrition was lower in the videoconference group, and there were a similar levels of weight loss in both groups regardless of delivery modality. Videoconference weight loss interventions are effective and feasible for scaling to support healthy weight management in military as well as civilian populations.",2019,"Attrition was lower in the videoconference group, and there were a similar levels of weight loss in both groups regardless of delivery modality.","['Forty-three participants were enrolled from two military installations and received either the', 'military families', 'adult family members of military service members']","['Videoconference interventions', 'videoconference adaption of Group Lifestyle Balance (GLB) program, a community group-based Diabetes Prevention Program intervention', 'GLB program', 'videoconference-adapted or an in-person GLB program', 'Videoconference weight loss interventions']","['weight loss', 'program attendance and percent weight lost', 'Participant retention', 'Attrition', 'Weight Loss', 'percent body weight', 'percentage of weight lost', 'body weight']","[{'cui': 'C0450368', 'cui_str': '43 (qualifier value)'}, {'cui': 'C0026126', 'cui_str': 'Armed Forces Personnel'}, {'cui': 'C3850016', 'cui_str': 'Families of Military Personnel'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086282', 'cui_str': 'Person in the family'}, {'cui': 'C0336524', 'cui_str': 'Military services member'}]","[{'cui': 'C1450049', 'cui_str': 'Videoconference'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}]","[{'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0439165', 'cui_str': 'Percent (property) (qualifier value)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}]",43.0,0.0274571,"Attrition was lower in the videoconference group, and there were a similar levels of weight loss in both groups regardless of delivery modality.","[{'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Taetzsch', 'Affiliation': 'Jean Mayer USDA Human Nutrition Research Center on Aging, Tufts University, 711 Washington St Boston, MA 02111.'}, {'ForeName': 'Cheryl H', 'Initials': 'CH', 'LastName': 'Gilhooly', 'Affiliation': 'Jean Mayer USDA Human Nutrition Research Center on Aging, Tufts University, 711 Washington St Boston, MA 02111.'}, {'ForeName': 'Asma', 'Initials': 'A', 'LastName': 'Bukhari', 'Affiliation': 'Walter Reed National Military Medical Center, 8901 Wisconsin Ave., Bethesda, MD 20889.'}, {'ForeName': 'Sai Krupa', 'Initials': 'SK', 'LastName': 'Das', 'Affiliation': 'Jean Mayer USDA Human Nutrition Research Center on Aging, Tufts University, 711 Washington St Boston, MA 02111.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Martin', 'Affiliation': 'Jean Mayer USDA Human Nutrition Research Center on Aging, Tufts University, 711 Washington St Boston, MA 02111.'}, {'ForeName': 'Adrienne M', 'Initials': 'AM', 'LastName': 'Hatch', 'Affiliation': 'U.S. Army Research Institute of Environmental Medicine, Military Nutrition Division, 10 General Greene Ave., Natick, MA 01760.'}, {'ForeName': 'Rachel E', 'Initials': 'RE', 'LastName': 'Silver', 'Affiliation': 'Jean Mayer USDA Human Nutrition Research Center on Aging, Tufts University, 711 Washington St Boston, MA 02111.'}, {'ForeName': 'Scott J', 'Initials': 'SJ', 'LastName': 'Montain', 'Affiliation': 'U.S. Army Research Institute of Environmental Medicine, Military Nutrition Division, 10 General Greene Ave., Natick, MA 01760.'}, {'ForeName': 'Susan B', 'Initials': 'SB', 'LastName': 'Roberts', 'Affiliation': 'Jean Mayer USDA Human Nutrition Research Center on Aging, Tufts University, 711 Washington St Boston, MA 02111.'}]",Military medicine,['10.1093/milmed/usz069'] 630,31243035,"DONORS (Donation Network to Optimise Organ Recovery Study): Study protocol to evaluate the implementation of an evidence-based checklist for brain-dead potential organ donor management in intensive care units, a cluster randomised trial.","INTRODUCTION There is an increasing demand for multi-organ donors for organ transplantation programmes. This study protocol describes the Donation Network to Optimise Organ Recovery Study, a planned cluster randomised controlled trial that aims to evaluate the effectiveness of the implementation of an evidence-based, goal-directed checklist for brain-dead potential organ donor management in intensive care units (ICUs) in reducing the loss of potential donors due to cardiac arrest. METHODS AND ANALYSIS The study will include ICUs of at least 60 Brazilian sites with an average of ≥10 annual notifications of valid potential organ donors. Hospitals will be randomly assigned (with a 1:1 allocation ratio) to the intervention group, which will involve the implementation of an evidence-based, goal-directed checklist for potential organ donor maintenance, or the control group, which will maintain the usual care practices of the ICU. Team members from all participating ICUs will receive training on how to conduct family interviews for organ donation. The primary outcome will be loss of potential donors due to cardiac arrest. Secondary outcomes will include the number of actual organ donors and the number of organs recovered per actual donor. ETHICS AND DISSEMINATION The institutional review board (IRB) of the coordinating centre and of each participating site individually approved the study. We requested a waiver of informed consent for the IRB of each site. Study results will be disseminated to the general medical community through publications in peer-reviewed medical journals. TRIAL REGISTRATION NUMBER NCT03179020; Pre-results.",2019,"Hospitals will be randomly assigned (with a 1:1 allocation ratio) to the intervention group, which will involve the implementation of an evidence-based, goal-directed checklist for potential organ donor maintenance, or the control group, which will maintain the usual care practices of the ICU.",['ICUs of at least 60 Brazilian sites with an average of ≥10\u2009annual notifications of valid potential organ donors'],[],"['loss of potential donors due to cardiac arrest', 'number of actual organ donors and the number of organs recovered per actual donor']","[{'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}, {'cui': 'C0422202', 'cui_str': 'Notifications (procedure)'}, {'cui': 'C0029206', 'cui_str': 'Organ donor (person)'}]",[],"[{'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0018790', 'cui_str': 'Cardiac Arrest'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0029206', 'cui_str': 'Organ donor (person)'}]",,0.11596,"Hospitals will be randomly assigned (with a 1:1 allocation ratio) to the intervention group, which will involve the implementation of an evidence-based, goal-directed checklist for potential organ donor maintenance, or the control group, which will maintain the usual care practices of the ICU.","[{'ForeName': 'Glauco Adrieno', 'Initials': 'GA', 'LastName': 'Westphal', 'Affiliation': 'Research Projects Office, Hospital Moinhos de Vento (HMV), Porto Alegre, Brazil.'}, {'ForeName': 'Caroline Cabral', 'Initials': 'CC', 'LastName': 'Robinson', 'Affiliation': 'Research Projects Office, Hospital Moinhos de Vento (HMV), Porto Alegre, Brazil.'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Biasi', 'Affiliation': 'Research Institute, Hospital do Coração (HCor), São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Flávia Ribeiro', 'Initials': 'FR', 'LastName': 'Machado', 'Affiliation': 'Department of Anaesthesiology, Pain and Intensive Care, Universidade Federal de São Paulo (UNIFESP), São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Regis Goulart', 'Initials': 'RG', 'LastName': 'Rosa', 'Affiliation': 'Adult Intensive Care Unit, Hospital Moinhos de Vento (HMV), Porto Alegre, Rio Grande do Sul, Brazil.'}, {'ForeName': 'Cassiano', 'Initials': 'C', 'LastName': 'Teixeira', 'Affiliation': 'Adult Intensive Care Unit, Hospital Moinhos de Vento (HMV), Porto Alegre, Rio Grande do Sul, Brazil.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'de Andrade', 'Affiliation': 'Organ Procurement Organisation of Santa Catarina (OPO/SC), Florianópolis, Brazil.'}, {'ForeName': 'Cristiano Augusto', 'Initials': 'CA', 'LastName': 'Franke', 'Affiliation': 'Adult Intensive Care Unit, Hospital das Clínicas de Porto Alegre (HCPA), Porto Alegre, Brazil.'}, {'ForeName': 'Luciano Cesar Pontes', 'Initials': 'LCP', 'LastName': 'Azevedo', 'Affiliation': 'Intensive Care Unit, Hospital Sírio-Libanês, São Paulo, Brazil.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Bozza', 'Affiliation': ""Department of Critical Care and Graduate Programme in Translational Medicine, D'Or Institute for Research and Education, Rio de Janeiro, Brazil, Rio de Janeiro, Brazil.""}, {'ForeName': 'Cátia Moreira', 'Initials': 'CM', 'LastName': 'Guterres', 'Affiliation': 'Research Projects Office, Hospital Moinhos de Vento (HMV), Porto Alegre, Brazil.'}, {'ForeName': 'Daiana Barbosa', 'Initials': 'DB', 'LastName': 'da Silva', 'Affiliation': 'Adult Intensive Care Unit, Hospital Moinhos de Vento (HMV), Porto Alegre, Rio Grande do Sul, Brazil.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Sganzerla', 'Affiliation': 'Research Projects Office, Hospital Moinhos de Vento (HMV), Porto Alegre, Brazil.'}, {'ForeName': 'Débora Zechmeister', 'Initials': 'DZ', 'LastName': 'do Prado', 'Affiliation': 'Research Projects Office, Hospital Moinhos de Vento (HMV), Porto Alegre, Brazil.'}, {'ForeName': 'Itiana Cardoso', 'Initials': 'IC', 'LastName': 'Madalena', 'Affiliation': 'Research Projects Office, Hospital Moinhos de Vento (HMV), Porto Alegre, Brazil.'}, {'ForeName': 'Adriane Isabel', 'Initials': 'AI', 'LastName': 'Rohden', 'Affiliation': 'Research Projects Office, Hospital Moinhos de Vento (HMV), Porto Alegre, Brazil.'}, {'ForeName': 'Sabrina Souza', 'Initials': 'SS', 'LastName': 'da Silva', 'Affiliation': 'Research Projects Office, Hospital Moinhos de Vento (HMV), Porto Alegre, Brazil.'}, {'ForeName': 'Natalia Elis', 'Initials': 'NE', 'LastName': 'Giordani', 'Affiliation': 'Research Projects Office, Hospital Moinhos de Vento (HMV), Porto Alegre, Brazil.'}, {'ForeName': 'Luiza Vitelo', 'Initials': 'LV', 'LastName': 'Andrighetto', 'Affiliation': 'Research Projects Office, Hospital Moinhos de Vento (HMV), Porto Alegre, Brazil.'}, {'ForeName': 'Patrícia Spessatto', 'Initials': 'PS', 'LastName': 'Benck', 'Affiliation': 'Research Projects Office, Hospital Moinhos de Vento (HMV), Porto Alegre, Brazil.'}, {'ForeName': 'Fernando Roberto', 'Initials': 'FR', 'LastName': 'Roman', 'Affiliation': 'Adult Intensive Care Unit, Hospital Bom Jesus de Toledo, Toledo, Brazil.'}, {'ForeName': 'Maria de Fátima Rodrigues Buarque', 'Initials': 'MFRB', 'LastName': 'de Melo', 'Affiliation': 'Adult Intensive Care Unit, Hospital da Restauração, Recife, Brazil.'}, {'ForeName': 'Thattyane Borba', 'Initials': 'TB', 'LastName': 'Pereira', 'Affiliation': 'Adult Intensive Care Unit, Hospital de Pronto Socorro João Paulo II, Porto Velho, Brazil.'}, {'ForeName': 'Cintia Magalhães Carvalho', 'Initials': 'CMC', 'LastName': 'Grion', 'Affiliation': 'Adult Intensive Care Unit, Hospital Evangélico de Londrina, Londrina, Brazil.'}, {'ForeName': 'Pedro Carvalho', 'Initials': 'PC', 'LastName': 'Diniz', 'Affiliation': 'Adult Intensive Care Unit, Hospital de Ensino Doutor Washington Antônio de Barros, Petrolina, Brazil.'}, {'ForeName': 'João Fernando Picollo', 'Initials': 'JFP', 'LastName': 'Oliveira', 'Affiliation': 'Adult Intensive Care Unit, Hospital de Base de São José do Rio Preto, São José do Rio Preto, Brazil.'}, {'ForeName': 'Giovana Colozza', 'Initials': 'GC', 'LastName': 'Mecatti', 'Affiliation': 'Adult Intensive Care Unit, Hospital Universitário São Francisco da Providência de Deus de Bragança Paulista, Bragança Paulista, Brazil.'}, {'ForeName': 'Flávio André Cardona', 'Initials': 'FAC', 'LastName': 'Alves', 'Affiliation': 'Adult Intensive Care Unit, Hospital Cristo Redentor, Porto Alegre, Brazil.'}, {'ForeName': 'Rafael Barberena', 'Initials': 'RB', 'LastName': 'Moraes', 'Affiliation': 'Adult Intensive Care Unit, Hospital das Clínicas de Porto Alegre (HCPA), Porto Alegre, Brazil.'}, {'ForeName': 'Vandack', 'Initials': 'V', 'LastName': 'Nobre', 'Affiliation': 'Adult Intensive Care Unit, Universidade Federal de Minas Gerais, Belo Horizonte, Brazil.'}, {'ForeName': 'Luciano Serpa', 'Initials': 'LS', 'LastName': 'Hammes', 'Affiliation': 'Superintendence, Hospital Moinhos de Vento, Porto Alegre, Brazil.'}, {'ForeName': 'Maureen O', 'Initials': 'MO', 'LastName': 'Meade', 'Affiliation': 'Department of Medicine and Department of Health Evidence and Impact, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Rosana Reis', 'Initials': 'RR', 'LastName': 'Nothen', 'Affiliation': 'General Hospital of the School of Medicine, Universidade Federal do Rio Grande do Sul (UFRGS), Porto Alegre, Brazil.'}, {'ForeName': 'Maicon', 'Initials': 'M', 'LastName': 'Falavigna', 'Affiliation': 'Research Projects Office, Hospital Moinhos de Vento (HMV), Porto Alegre, Brazil.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ open,['10.1136/bmjopen-2018-028570'] 631,31248918,The use of brain functional magnetic resonance imaging to determine the mechanism of action of gabapentin in managing chronic pelvic pain in women: a pilot study.,"OBJECTIVE To inform feasibility and design of a future randomised controlled trial (RCT) using brain functional MRI (fMRI) to determine the mechanism of action of gabapentin in managing chronic pelvic pain (CPP) in women. DESIGN Mechanistic study embedded in pilot RCT. SETTING University Hospital. PARTICIPANTS Twelve women (18-50 years) with CPP and no pelvic pathology (follow-up completed March 2014). INTERVENTION Oral gabapentin (300-2700 mg) or matched placebo. OUTCOME MEASURES After 12 weeks of treatment, participants underwent fMRI of the brain (Verio Siemens 3T MRI) during which noxious heat and punctate stimuli were delivered to the pelvis and arm. Outcome measures included pain (visual analogue scale), blood oxygen level dependent signal change and a semi-structured acceptability questionnaire at study completion prior to unblinding. RESULTS Full datasets were obtained for 11 participants. Following noxious heat to the abdomen, the gabapentin group (GG) had lower pain scores (Mean: 3.8 [SD 2.2]) than the placebo group (PG) (Mean: 5.8 [SD 0.9]). This was also the case for noxious heat to the arm with the GG having lower pain scores (Mean: 2.6 [SD 2.5]) than the PG (Mean: 6.2 [SD 1.1]). Seven out of 12 participants completed the acceptability questionnaire. 71% (five out of seven) described their participation in the fMRI study as positive; the remaining two rated it as a negative experience. CONCLUSIONS Incorporating brain fMRI in a future RCT to determine the mechanism of action of gabapentin in managing CPP in women was feasible and acceptable to most women. TRIAL REGISTRATION NUMBER ISRCTN70960777.",2019,This was also the case for noxious heat to the arm with the GG having lower pain scores (Mean: 2.6 [SD 2.5]) than the PG (Mean: 6.2 [SD 1.1]).,"['University Hospital', 'Twelve women (18-50 years) with CPP and no pelvic pathology (follow-up completed March 2014', 'women', 'managing chronic pelvic pain (CPP) in women']","['gabapentin', 'Oral gabapentin', 'placebo', 'brain functional MRI (fMRI']","['acceptability questionnaire', 'pain (visual analogue scale), blood oxygen level dependent signal change and a semi-structured acceptability questionnaire at study completion prior to unblinding', 'pain scores']","[{'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0047123', 'cui_str': 'CPP'}, {'cui': 'C0030797', 'cui_str': 'Pelvic Region'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0030794', 'cui_str': 'Pelvic Pain'}]","[{'cui': 'C0060926', 'cui_str': 'gabapentin'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0376335', 'cui_str': 'fMRI'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0005768'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}]",12.0,0.190688,This was also the case for noxious heat to the arm with the GG having lower pain scores (Mean: 2.6 [SD 2.5]) than the PG (Mean: 6.2 [SD 1.1]).,"[{'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Seretny', 'Affiliation': 'Edinburgh Cancer Research UK Centre, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Sarah Rose', 'Initials': 'SR', 'LastName': 'Murray', 'Affiliation': 'MRC Centre for Reproductive Health, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Whitaker', 'Affiliation': 'MRC Centre for Reproductive Health, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Murnane', 'Affiliation': 'Queens Medical Research Institute and Edinburgh Imaging Facility (QMRI), University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Whalley', 'Affiliation': 'Centre for Clinical Brain Sciences, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Cyril', 'Initials': 'C', 'LastName': 'Pernet', 'Affiliation': 'Queens Medical Research Institute and Edinburgh Imaging Facility (QMRI), University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Andrew W', 'Initials': 'AW', 'LastName': 'Horne', 'Affiliation': 'MRC Centre for Reproductive Health, University of Edinburgh, Edinburgh, UK.'}]",BMJ open,['10.1136/bmjopen-2018-026152'] 632,32091672,The clinical utility of remote ischemic preconditioning in protecting against cardiac surgery-associated acute kidney injury: A pilot randomized clinical trial.,"BACKGROUND Cardiac surgery-associated acute kidney injury (CSA-AKI) is a well-known, serious complication and a well-recognized independent risk factor for higher morbidity and mortality among patients undergoing cardiac surgery. OBJECTIVES The aim of the study was to assess the efficacy of remote ischemic preconditioning (RIPC) in reducing the incidence of CSA-AKI, measured with the standard creatinine technique and using neutrophil gelatinase-associated lipocalin (NGAL) serum concentrations as a potential new biomarker of kidney damage. The ethics committee of the Medical University of Lodz prospectively approved the protocol (approval No. RNN/286/13/KE). The study was retrospectively registered with the U.S. National Institutes of Health - NIH (29 June 2017; ClinicalTrials.gov identifier: NCT03205410). MATERIAL AND METHODS We conducted a prospective single-center double-blind randomized and controlled tudy. Data was collected from patients admitted to the Cardiosurgery Clinic at the Medical University of Lodz (Poland) between January and December 2014, scheduled for elective cardiac surgery (an off-pump coronary artery bypass). A total of 28 patients were randomized to receive either RIPC (n = 14) or sham RIPC (n = 14). After the induction of anesthesia, the patients assigned to the RIPC group underwent 3 cycles of five-minute inflation to 200 mm Hg and five-minute deflation of the upper-arm cuff. The control group had a deflated cuff placed on the upper arm for 30 min. The authors measured the patients' serum creatinine concentration to check for the occurrence of a CSA-AKI within 48 h after cardiac surgery, and NGAL serum concentration to check its level within 3 h after the operation. RESULTS Fewer patients in RIPC group developed CSA-AKI within 48 h after cardiac surgery than in the control group (29% vs 93%; p = 0.003). Fewer patients in the RIPC group presented an increase in NGAL 3 h after surgery (medians: 124 vs 176.7; p = 0.0003). CONCLUSIONS In patients undergoing an off-pump coronary artery bypass, RIPC significantly reduces the occurrence of CSA-AKI and protects against increased postoperative NGAL levels.",2020,"In patients undergoing an off-pump coronary artery bypass, RIPC significantly reduces the occurrence of CSA-AKI and protects against increased postoperative NGAL levels.","['protecting against cardiac surgery-associated acute kidney injury', 'patients admitted to the Cardiosurgery Clinic at the Medical University of Lodz (Poland) between January and December 2014, scheduled for elective cardiac surgery (an off-pump coronary artery bypass', 'The study was retrospectively registered with the U.S. National Institutes of Health - NIH (29 June 2017', '28 patients', 'patients undergoing cardiac surgery']","['remote ischemic preconditioning (RIPC', 'remote ischemic preconditioning', 'sham RIPC', 'RIPC']","['CSA-AKI', 'occurrence of CSA-AKI and protects against increased postoperative NGAL levels']","[{'cui': 'C0524727', 'cui_str': 'Surgery, Cardiac'}, {'cui': 'C2609414', 'cui_str': 'Acute Renal Injury'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C1449706', 'cui_str': 'Coronary Artery Bypass, Off-Pump'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0018684', 'cui_str': 'Health'}]","[{'cui': 'C0205157', 'cui_str': 'Remote (qualifier value)'}, {'cui': 'C0376466', 'cui_str': 'Ischemic Pre-Conditioning'}, {'cui': 'C0475224', 'cui_str': 'Ischemic (qualifier value)'}, {'cui': 'C1709632', 'cui_str': 'Precondition (attribute)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}]","[{'cui': 'C0258591', 'cui_str': 'cyclosporin A, 4-(2-butenyl)-4,4,N-trimethylthreonine(1)-'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",28.0,0.276007,"In patients undergoing an off-pump coronary artery bypass, RIPC significantly reduces the occurrence of CSA-AKI and protects against increased postoperative NGAL levels.","[{'ForeName': 'Karolina', 'Initials': 'K', 'LastName': 'Stokfisz', 'Affiliation': 'Intensive Cardiac Therapy Clinic, Department of Invasive Cardiology and Electrocardiology, Medical University of Lodz, Poland.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Ledakowicz-Polak', 'Affiliation': 'Intensive Cardiac Therapy Clinic, Department of Invasive Cardiology and Electrocardiology, Medical University of Lodz, Poland.'}, {'ForeName': 'Maciej', 'Initials': 'M', 'LastName': 'Zagórski', 'Affiliation': 'Cardiosurgery Clinic, Department of Cardiology and Cardiosurgery, Medical University of Lodz, Poland.'}, {'ForeName': 'Sławomir', 'Initials': 'S', 'LastName': 'Jander', 'Affiliation': 'Cardiosurgery Clinic, Department of Cardiology and Cardiosurgery, Medical University of Lodz, Poland.'}, {'ForeName': 'Katarzyna', 'Initials': 'K', 'LastName': 'Przybylak', 'Affiliation': 'Intensive Cardiac Therapy Clinic, Department of Invasive Cardiology and Electrocardiology, Medical University of Lodz, Poland.'}, {'ForeName': 'Marzenna', 'Initials': 'M', 'LastName': 'Zielińska', 'Affiliation': 'Intensive Cardiac Therapy Clinic, Department of Invasive Cardiology and Electrocardiology, Medical University of Lodz, Poland.'}]",Advances in clinical and experimental medicine : official organ Wroclaw Medical University,['10.17219/acem/112610'] 633,30962264,Protective effect of dexmedetomidine on kidney injury of parturients with preeclampsia undergoing cesarean section: a randomized controlled study.,"The present study aimed to elucidate the effects of dexmedetomidine on kidney injury of parturients with preeclampsia (PE) undergoing cesarean section. Total 134 cesarean delivery women with PE were randomly divided into intervention group (IG) and control group (CG). Both groups underwent combined spinal and epidural anesthesia (CSEA), the IG was treated with 0.4 μg/(kg·min) dexmedetomidine for 10 min before surgery. The CG was treated with equivalent saline. Heart rate (HR), blood pressure, oxygen saturation (SpO 2 ) of the two groups were measured at different time point after administration. Level of inflammatory factors were detected by enzyme-linked immunosorbent assay (ELISA). Visual analogue score (VAS), Ramsay sedation score (RSS), and kidney injury related indexes were evaluated at different time points. The plasma-drug concentration of patients was determined by High Performance Liquid Chromatography (HPLC) method. Compared with CG, HR, PE, and diastolic blood pressure (DBP) showed lower level while SpO 2 showed higher level in IG. Furthermore, expression of tumor necrosis factor α (TNF-α), interleukin-6 (IL-6), and IL-10 in IG was decreased after drug administration, the contents of β2-MG, KIM-1 and urine protein were also decreased in contrast to the CG (all P <0.05). Besides, VAS score was decreased but Ramsay score was increased in the IG (both P <0.05). The results of HPLC showed that the half life of dexmedetomidine was about 20 min and it is speculated that the drug can be quickly metabolized within 24 h. Dexmedetomidine exerted protective effects on kidney injury of parturients with PE undergoing cesarean section.",2019,"Besides, VAS score was decreased but Ramsay score was increased in the IG (both P <0.05).","['Total 134 cesarean delivery women with PE', 'parturients with preeclampsia undergoing cesarean section', 'parturients with PE undergoing cesarean section', 'parturients with preeclampsia (PE) undergoing cesarean section']","['Dexmedetomidine', 'combined spinal and epidural anesthesia (CSEA), the IG was treated with 0.4 μg/(kg·min) dexmedetomidine', 'intervention group (IG) and control group (CG', 'equivalent saline', 'dexmedetomidine']","['Visual analogue score (VAS), Ramsay sedation score (RSS), and kidney injury related indexes', 'CG, HR, PE, and diastolic blood pressure (DBP', 'plasma-drug concentration', 'Ramsay score', 'VAS score', 'Heart rate (HR), blood pressure, oxygen saturation (SpO 2 ', 'Furthermore, expression of tumor necrosis factor α (TNF-α), interleukin-6 (IL-6), and IL-10 in IG', 'contents of β2-MG, KIM-1 and urine protein', 'Level of inflammatory factors']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4517565', 'cui_str': 'One hundred and thirty-four'}, {'cui': 'C1384674', 'cui_str': 'Deliveries by cesarean (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0032914', 'cui_str': 'EPH Toxemias'}, {'cui': 'C0007876', 'cui_str': 'C-Section (OB)'}]","[{'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0002913', 'cui_str': 'Anesthesia, Extradural'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C4517457', 'cui_str': 'Zero point four'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}]","[{'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0022646', 'cui_str': 'Kidney'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0523807', 'cui_str': 'Oximetry'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0041368', 'cui_str': 'Tumor Necrosis Factors'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C1305628', 'cui_str': 'Urine protein (substance)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",134.0,0.111232,"Besides, VAS score was decreased but Ramsay score was increased in the IG (both P <0.05).","[{'ForeName': 'Qing-Lin', 'Initials': 'QL', 'LastName': 'Zhang', 'Affiliation': 'Department of Anesthesiology, Xuanwu Hospital, Capital Medical University, Beijing 100053, P.R. China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Gynaecological Oncology, Beijing Haidian Maternal & Child Health Hospital, Beijing 100080, P.R. China.'}, {'ForeName': 'Ming-Jun', 'Initials': 'MJ', 'LastName': 'Xu', 'Affiliation': 'Department of Anesthesiology, Beijing Obsterics and Gynecology Hospital, Capital Medical University, Beijing 100020, P.R. China.'}, {'ForeName': 'Tian-Long', 'Initials': 'TL', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, Xuanwu Hospital, Capital Medical University, Beijing 100053, P.R. China drtianlongwang@163.com.'}]",Bioscience reports,['10.1042/BSR20190352'] 634,31256021,Thresholds for clinically important deterioration versus improvement in COPD health status: results from a randomised controlled trial in pulmonary rehabilitation and an observational study during routine clinical practice.,"OBJECTIVES Chronic Obstructive Pulmonary Disease (COPD) is a progressive disease. Preventing deterioration of health status is therefore an important therapy goal. (Minimal) Clinically Important Differences ((M)CIDs) are used to interpret changes observed. It remains unclear whether (M)CIDs are similar for both deterioration and improvement in health status. This study investigates and compares these clinical thresholds for three widely-used questionnaires. DESIGN AND SETTING Data were retrospectively analysed from an inhouse 3-week pulmonary rehabilitation (PR) randomised controlled trial in the German Klinik Bad Reichenhall (study 1), and observational research in Dutch primary and secondary routine clinical practice (RCP) (study 2). PARTICIPANTS Patients with COPD aged ≥18 years (study 1) and aged ≥40 years (study 2) without respiratory comorbidities were included for analysis. PRIMARY OUTCOMES The COPD Assessment Test (CAT), Clinical COPD Questionnaire (CCQ) and St George's Respiratory Questionnaire (SGRQ) were completed at baseline and at 3, 6 and 12 months. A Global Rating of Change scale was added at follow-up. Anchor-based and distribution-based methods were used to determine clinically relevant thresholds. RESULTS In total, 451 patients were included from PR and 207 from RCP. MCIDs for deterioration ranged from 1.30 to 4.21 (CAT), from 0.19 to 0.66 (CCQ), and from 2.75 to 7.53 (SGRQ). MCIDs for improvement ranged from -3.78 to -1.53 (CAT), from -0.50 to -0.19 (CCQ), and from -9.20 to -2.76 (SGRQ). Thresholds for moderate improvement versus deterioration ranged from -5.02 to -3.29 vs 3.89 to 8.14 (CAT), from -0.90 to -0.72 vs 0.42 to 1.23 (CCQ), and from -15.85 to -13.63 vs 7.46 to 9.30 (SGRQ). CONCLUSIONS MCID ranges for improvement and deterioration on the CAT, CCQ and SGRQ were somewhat similar. However, estimates for moderate and large change varied and were inconsistent. Thresholds differed between study settings. TRIAL REGISTRATION NUMBER Routine Inspiratory Muscle Training within COPD Rehabilitation trial: #DRKS00004609; MCID study: #UMCG201500447.",2019,"Thresholds for moderate improvement versus deterioration ranged from -5.02 to -3.29 vs 3.89 to 8.14 (CAT), from -0.90 to -0.72 vs 0.42 to 1.23 (CCQ), and from -15.85 to -13.63 vs 7.46 to 9.30 (SGRQ). ","['Patients with COPD aged ≥18 years (study 1) and aged ≥40 years (study 2) without respiratory comorbidities were included for analysis', '451 patients were included from PR and 207 from RCP', 'Chronic Obstructive Pulmonary Disease (COPD', 'Data were retrospectively analysed from an inhouse 3-week pulmonary rehabilitation (PR) randomised controlled trial in the German Klinik Bad Reichenhall (study 1), and observational research in Dutch primary and secondary routine clinical practice (RCP) (study 2']",[],"['MCIDs', 'CAT, CCQ and SGRQ', ""COPD Assessment Test (CAT), Clinical COPD Questionnaire (CCQ) and St George's Respiratory Questionnaire (SGRQ""]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0199529', 'cui_str': 'Pulmonary rehabilitation (regime/therapy)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1556085', 'cui_str': 'Germans (ethnic group)'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0035168'}, {'cui': 'C0013331', 'cui_str': 'Dutch (ethnic group)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}]",[],"[{'cui': 'C0524517', 'cui_str': 'Felis'}, {'cui': 'C4284282', 'cui_str': 'COPD assessment test'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",451.0,0.0700561,"Thresholds for moderate improvement versus deterioration ranged from -5.02 to -3.29 vs 3.89 to 8.14 (CAT), from -0.90 to -0.72 vs 0.42 to 1.23 (CCQ), and from -15.85 to -13.63 vs 7.46 to 9.30 (SGRQ). ","[{'ForeName': 'Harma Johanna', 'Initials': 'HJ', 'LastName': 'Alma', 'Affiliation': 'Department of General Practice and Elderly Care Medicine, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Corina', 'Initials': 'C', 'LastName': 'de Jong', 'Affiliation': 'Department of General Practice and Elderly Care Medicine, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Danijel', 'Initials': 'D', 'LastName': 'Jelusic', 'Affiliation': 'Center for Rehabilitation, Pulmonology and Orthopedics, Klinik Bad Reichenhall, Bad Reichenhall, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Wittmann', 'Affiliation': 'Center for Rehabilitation, Pulmonology and Orthopedics, Klinik Bad Reichenhall, Bad Reichenhall, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Schuler', 'Affiliation': 'Institute for Clinical Epidemiology and Biometry (ICE-B), Julius-Maximilians-Universität Würzburg, Würzburg, Bayern, Germany.'}, {'ForeName': 'Robbert', 'Initials': 'R', 'LastName': 'Sanderman', 'Affiliation': 'Department of Health Psychology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Konrad', 'Initials': 'K', 'LastName': 'Schultz', 'Affiliation': 'Center for Rehabilitation, Pulmonology and Orthopedics, Klinik Bad Reichenhall, Bad Reichenhall, Germany.'}, {'ForeName': 'Janwillem', 'Initials': 'J', 'LastName': 'Kocks', 'Affiliation': 'Department of General Practice and Elderly Care Medicine, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Thys', 'Initials': 'T', 'LastName': 'van der Molen', 'Affiliation': 'Department of General Practice and Elderly Care Medicine, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}]",BMJ open,['10.1136/bmjopen-2018-025776'] 635,31256036,Oral insulin therapy for primary prevention of type 1 diabetes in infants with high genetic risk: the GPPAD-POInT (global platform for the prevention of autoimmune diabetes primary oral insulin trial) study protocol.,"INTRODUCTION The POInT study, an investigator initiated, randomised, placebo-controlled, double-blind, multicentre primary prevention trial is conducted to determine whether daily administration of oral insulin, from age 4.0 months to 7.0 months until age 36.0 months to children with elevated genetic risk for type 1 diabetes, reduces the incidence of beta-cell autoantibodies and diabetes. METHODS AND ANALYSIS Infants aged 4.0 to 7.0 months from Germany, Poland, Belgium, UK and Sweden are eligible if they have a >10.0% expected risk for developing multiple beta-cell autoantibodies as determined by genetic risk score or family history and human leucocyte antigen genotype. Infants are randomised 1:1 to daily oral insulin (7.5 mg for 2 months, 22.5 mg for 2 months, 67.5 mg until age 36.0 months) or placebo, and followed for a maximum of 7 years. Treatment and follow-up is stopped if a child develops diabetes. The primary outcome is the development of persistent confirmed multiple beta-cell autoantibodies or diabetes. Other outcomes are: (1) Any persistent confirmed beta-cell autoantibody (glutamic acid decarboxylase (GADA), IA-2A, autoantibodies to insulin (IAA) and zinc transporter 8 or tetraspanin 7), or diabetes, (2) Persistent confirmed IAA, (3) Persistent confirmed GADA and (4) Abnormal glucose tolerance or diabetes. ETHICS AND DISSEMINATION The study is approved by the ethical committees of all participating clinical sites. The results will be disseminated through peer-reviewed journals and conference presentations and will be openly shared after completion of the trial. TRIAL REGISTRATION NUMBER NCT03364868.",2019,"IA-2A, autoantibodies to insulin (IAA) and zinc transporter 8 or tetraspanin 7), or diabetes, (2) Persistent confirmed IAA, (3) Persistent confirmed GADA and (4)","['Infants aged 4.0 to 7.0 months from Germany, Poland, Belgium, UK and Sweden are eligible if they have a >10.0% expected risk for developing multiple beta-cell autoantibodies as determined by genetic risk score or family history and human leucocyte antigen genotype', 'children with elevated genetic risk for type 1 diabetes', 'infants with high genetic risk']","['oral insulin', 'daily oral insulin', 'Oral insulin therapy', 'placebo']","['beta-cell autoantibody (glutamic acid decarboxylase (GADA', 'Abnormal glucose tolerance or diabetes', 'development of persistent confirmed multiple beta-cell autoantibodies or diabetes', 'IA-2A, autoantibodies to insulin (IAA) and zinc transporter 8 or tetraspanin 7), or diabetes, (2) Persistent confirmed IAA, (3) Persistent confirmed GADA and (4', 'incidence of beta-cell autoantibodies and diabetes']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0032356', 'cui_str': 'Republic of Poland'}, {'cui': 'C0004950', 'cui_str': 'Belgium'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0330390', 'cui_str': 'Beta (organism)'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0004358', 'cui_str': 'Autoantibodies'}, {'cui': 'C0521095', 'cui_str': 'Determined by (contextual qualifier) (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0019665', 'cui_str': 'historical aspects'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0427359', 'cui_str': 'Human leukocyte antigen genotype'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0017399', 'cui_str': 'genetics'}, {'cui': 'C0441729', 'cui_str': 'Type 1 (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0330390', 'cui_str': 'Beta (organism)'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0004358', 'cui_str': 'Autoantibodies'}, {'cui': 'C0017785', 'cui_str': 'Glutamate Carboxy-Lyase'}, {'cui': 'C0235401', 'cui_str': 'Abnormal glucose tolerance'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C4019440', 'cui_str': 'Slc30A8 Protein'}, {'cui': 'C3178812', 'cui_str': 'Tetraspanins'}, {'cui': 'C0220856', 'cui_str': 'incidence'}]",,0.362082,"IA-2A, autoantibodies to insulin (IAA) and zinc transporter 8 or tetraspanin 7), or diabetes, (2) Persistent confirmed IAA, (3) Persistent confirmed GADA and (4)","[{'ForeName': 'Anette-Gabriele', 'Initials': 'AG', 'LastName': 'Ziegler', 'Affiliation': 'Institute of Diabetes Research, Helmholtz Zentrum München, Neuherberg, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Achenbach', 'Affiliation': 'Institute of Diabetes Research, Helmholtz Zentrum München, Neuherberg, Germany.'}, {'ForeName': 'Reinhard', 'Initials': 'R', 'LastName': 'Berner', 'Affiliation': 'Department of Paediatrics, University Hospital Carl Gustav Carus, Technische Universität Dresden, Dresden, Germany.'}, {'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Casteels', 'Affiliation': 'Department of Paediatrics, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Danne', 'Affiliation': 'Kinder- und Jugendkrankenhaus AUF DER BULT, Hannover, Germany.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Gündert', 'Affiliation': 'Institute of Diabetes Research, Helmholtz Zentrum München, Neuherberg, Germany.'}, {'ForeName': 'Joerg', 'Initials': 'J', 'LastName': 'Hasford', 'Affiliation': 'Institut für Medizinische Informationsverarbeitung, Biometrie und Epidemiologie, Ludwig-Maximilians-Universität München, Munich, Germany.'}, {'ForeName': 'Verena Sophia', 'Initials': 'VS', 'LastName': 'Hoffmann', 'Affiliation': 'Institute of Diabetes Research, Helmholtz Zentrum München, Neuherberg, Germany.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Kordonouri', 'Affiliation': 'Kinder- und Jugendkrankenhaus AUF DER BULT, Hannover, Germany.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Lange', 'Affiliation': 'Department of Medical Psychology, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Elding Larsson', 'Affiliation': 'Unit for Paediatric Endocrinology, Department of Clinical Sciences Malmö, Lund University, Sweden.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Lundgren', 'Affiliation': 'Unit for Paediatric Endocrinology, Department of Clinical Sciences Malmö, Lund University, Sweden.'}, {'ForeName': 'Matthew D', 'Initials': 'MD', 'LastName': 'Snape', 'Affiliation': 'Department of Paediatrics, University of Oxford, Oxford, UK.'}, {'ForeName': 'Agnieszka', 'Initials': 'A', 'LastName': 'Szypowska', 'Affiliation': 'Department of Paediatrics, Medical University of Warsaw, Warsaw, Poland.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Todd', 'Affiliation': 'Wellcome Centre for Human Genetics, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Ezio', 'Initials': 'E', 'LastName': 'Bonifacio', 'Affiliation': 'Centre for Regenerative Therapies Dresden (CRTD), Faculty of Medicine, Technische Universität Dresden, Dresden, Germany.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ open,['10.1136/bmjopen-2018-028578'] 636,31221870,Text messaging support for patients with diabetes or coronary artery disease (SupportMe): protocol for a pragmatic randomised controlled trial.,"INTRODUCTION Low-cost interventions providing self-management support are needed for people with coronary artery disease (CAD) and diabetes. Mobile phone text messaging provides a potential vehicle for this. The SupportMe Trial aims to assess the feasibility of embedding a text messaging programme into routine clinical practice and will determine if this improves cardiovascular risk factor and diabetes control among patients with CAD or type 2 diabetes. METHODS AND ANALYSIS SupportMe is a randomised controlled trial to be conducted within the framework of a health district-wide integrated care programme for people with CAD or type 2 diabetes mellitus. One thousand subjects will be recruited, with at least 500 in each group. Intervention subjects will receive four text messages a week for 6 months, which provide advice, motivation, information and support for disease management and healthy behaviour. The primary outcome is systolic blood pressure at 6 months. Secondary outcomes include body mass index, waist circumference, low-density lipoprotein cholesterol, physical activity levels, dietary intake, quality of life, mood and smoking cessation, and for subjects with diabetes, glycosylated haemoglobin and fasting serum glucose. A process and economic evaluation will also be conducted. ETHICS AND DISSEMINATION The study has been approved by the Western Sydney Local Health District Human Research Ethics Committee (AU RED HREC/16/WMEAD/331). Results will be disseminated via the scientific forums including peer-reviewed publications and presentations at national and international conferences. TRIAL REGISTRATION NUMBER ACTRN12616001689460.",2019,"INTRODUCTION Low-cost interventions providing self-management support are needed for people with coronary artery disease (CAD) and diabetes.","['patients with diabetes or coronary artery disease (SupportMe', 'people with CAD or type 2 diabetes mellitus', 'patients with CAD or type 2 diabetes', 'One thousand subjects will be recruited, with at least 500 in each group', 'people with coronary artery disease (CAD) and diabetes']","['Text messaging support', 'health district-wide integrated care programme']","['cardiovascular risk factor and diabetes control', 'body mass index, waist circumference, low-density lipoprotein cholesterol, physical activity levels, dietary intake, quality of life, mood and smoking cessation, and for subjects with diabetes, glycosylated haemoglobin and fasting serum glucose', 'systolic blood pressure']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}, {'cui': 'C0011860', 'cui_str': 'Diabetes Mellitus, Type 2'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C1883310', 'cui_str': '1000 (qualifier value)'}, {'cui': 'C3816747', 'cui_str': 'Five hundred'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0018684', 'cui_str': 'Health'}]","[{'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0034380'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0202041', 'cui_str': 'Glucose measurement, serum (procedure)'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}]",1000.0,0.208646,"INTRODUCTION Low-cost interventions providing self-management support are needed for people with coronary artery disease (CAD) and diabetes.","[{'ForeName': 'Ngai Wah', 'Initials': 'NW', 'LastName': 'Cheung', 'Affiliation': 'Diabetes & Endocrinology, University of Sydney, Westmead, New South Wales, Australia.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Redfern', 'Affiliation': 'Westmead Applied Research Centre, University of Sydney, Westmead, New South Wales, Australia.'}, {'ForeName': 'Aravinda', 'Initials': 'A', 'LastName': 'Thiagalingam', 'Affiliation': 'Westmead Clinical School, University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Tien-Ming', 'Initials': 'TM', 'LastName': 'Hng', 'Affiliation': 'Diabetes & Endocrinology, Blacktown Mount Druitt Hospital, Blacktown, New South Wales, Australia.'}, {'ForeName': 'Sheikh Mohammed Shariful', 'Initials': 'SMS', 'LastName': 'Islam', 'Affiliation': 'The George Institute for Global Health, Sydney, New South Wales, Australia.'}, {'ForeName': 'Rabbia', 'Initials': 'R', 'LastName': 'Haider', 'Affiliation': 'Diabetes & Endocrinology, University of Sydney, Westmead, New South Wales, Australia.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Faruquie', 'Affiliation': 'Diabetes & Endocrinology, University of Sydney, Westmead, New South Wales, Australia.'}, {'ForeName': 'Clara', 'Initials': 'C', 'LastName': 'Chow', 'Affiliation': 'Westmead Applied Research Centre, University of Sydney, Westmead, New South Wales, Australia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ open,['10.1136/bmjopen-2018-025923'] 637,31221872,Randomised controlled trial of a financial incentive for increasing the number of daily walking steps: study protocol.,"INTRODUCTION Physical activity is one of the major modifiable factors for promotion of public health. Although it has been reported that financial incentives would be effective for promoting health behaviours such as smoking cessation or attendance for cancer screening, few randomised controlled trials (RCTs) have examined the effect of financial incentives for increasing the number of daily steps among individuals in a community setting. The aim of this study is to investigate the effects of financial incentives for increasing the number of daily steps among community-dwelling adults in Japan. METHODS AND ANALYSIS This study will be a two-arm, parallel-group RCT. We will recruit community-dwelling adults who are physically inactive in a suburban area (Nakayama) of Sendai city, Japan, using leaflets and posters. Participants that meet the inclusion criteria will be randomly allocated to an intervention group or a waitlist control group. The intervention group will be offered a financial incentive (a chance to get shopping points) if participants increase their daily steps from their baseline. The primary outcome will be the average increase in the number of daily steps (at 4-6 weeks and 7-9 weeks) relative to the average number of daily steps at the baseline (1-3 weeks). For the sample size calculation, we assumed that the difference of primary outcome would be 1302 steps. ETHICS AND DISSEMINATION This study has been ethically approved by the research ethics committee of Tohoku University Graduate School of Medicine, Japan (No. 2018-1-171). The results will be submitted and published in a peer-reviewed scientific journal. TRIAL REGISTRATION NUMBER UMIN000033276; Pre-results.",2019,"Although it has been reported that financial incentives would be effective for promoting health behaviours such as smoking cessation or attendance for cancer screening, few randomised controlled trials (RCTs) have examined the effect of financial incentives for increasing the number of daily steps among individuals in a community setting.","['Tohoku University Graduate School of Medicine, Japan (No. 2018-1-171', 'community-dwelling adults in Japan', 'community-dwelling adults who are physically inactive in a suburban area (Nakayama) of Sendai city, Japan, using leaflets and posters']","['financial incentive', 'waitlist control group']","['average increase in the number of daily steps', 'average number of daily steps']","[{'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0588053', 'cui_str': 'Graduate (person)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C4045975', 'cui_str': 'Community Dwelling'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0376675', 'cui_str': 'Poster'}]","[{'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C1261552', 'cui_str': 'Step'}]",,0.20343,"Although it has been reported that financial incentives would be effective for promoting health behaviours such as smoking cessation or attendance for cancer screening, few randomised controlled trials (RCTs) have examined the effect of financial incentives for increasing the number of daily steps among individuals in a community setting.","[{'ForeName': 'Yasutake', 'Initials': 'Y', 'LastName': 'Tomata', 'Affiliation': 'Division of Epidemiology, Department of Health Informatics and PublicHealth, Tohoku University Graduate School of Medicine, Sendai, Japan.'}, {'ForeName': 'Fumiya', 'Initials': 'F', 'LastName': 'Tanji', 'Affiliation': 'Division of Epidemiology, Department of Health Informatics and PublicHealth, Tohoku University Graduate School of Medicine, Sendai, Japan.'}, {'ForeName': 'Dieta', 'Initials': 'D', 'LastName': 'Nurrika', 'Affiliation': 'Division of Epidemiology, Department of Health Informatics and PublicHealth, Tohoku University Graduate School of Medicine, Sendai, Japan.'}, {'ForeName': 'Yingxu', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Division of Epidemiology, Department of Health Informatics and PublicHealth, Tohoku University Graduate School of Medicine, Sendai, Japan.'}, {'ForeName': 'Saho', 'Initials': 'S', 'LastName': 'Abe', 'Affiliation': 'Division of Epidemiology, Department of Health Informatics and PublicHealth, Tohoku University Graduate School of Medicine, Sendai, Japan.'}, {'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Matsumoto', 'Affiliation': 'Division of Epidemiology, Department of Health Informatics and PublicHealth, Tohoku University Graduate School of Medicine, Sendai, Japan.'}, {'ForeName': 'Shu', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': 'Division of Epidemiology, Department of Health Informatics and PublicHealth, Tohoku University Graduate School of Medicine, Sendai, Japan.'}, {'ForeName': 'Yumika', 'Initials': 'Y', 'LastName': 'Kotaki', 'Affiliation': 'Division of Epidemiology, Department of Health Informatics and PublicHealth, Tohoku University Graduate School of Medicine, Sendai, Japan.'}, {'ForeName': 'Sanae', 'Initials': 'S', 'LastName': 'Matsuyama', 'Affiliation': 'Division of Epidemiology, Department of Health Informatics and PublicHealth, Tohoku University Graduate School of Medicine, Sendai, Japan.'}, {'ForeName': 'Yukai', 'Initials': 'Y', 'LastName': 'Lu', 'Affiliation': 'Division of Epidemiology, Department of Health Informatics and PublicHealth, Tohoku University Graduate School of Medicine, Sendai, Japan.'}, {'ForeName': 'Yumi', 'Initials': 'Y', 'LastName': 'Sugawara', 'Affiliation': 'Division of Epidemiology, Department of Health Informatics and PublicHealth, Tohoku University Graduate School of Medicine, Sendai, Japan.'}, {'ForeName': 'Shino', 'Initials': 'S', 'LastName': 'Bando', 'Affiliation': 'Division of Epidemiology, Department of Health Informatics and PublicHealth, Tohoku University Graduate School of Medicine, Sendai, Japan.'}, {'ForeName': 'Teiichiro', 'Initials': 'T', 'LastName': 'Yamazaki', 'Affiliation': 'Division of Epidemiology, Department of Health Informatics and PublicHealth, Tohoku University Graduate School of Medicine, Sendai, Japan.'}, {'ForeName': 'Tatsui', 'Initials': 'T', 'LastName': 'Otsuka', 'Affiliation': 'Division of Epidemiology, Department of Health Informatics and PublicHealth, Tohoku University Graduate School of Medicine, Sendai, Japan.'}, {'ForeName': 'Toshimasa', 'Initials': 'T', 'LastName': 'Sone', 'Affiliation': 'Division of Epidemiology, Department of Health Informatics and PublicHealth, Tohoku University Graduate School of Medicine, Sendai, Japan.'}, {'ForeName': 'Ichiro', 'Initials': 'I', 'LastName': 'Tsuji', 'Affiliation': 'Division of Epidemiology, Department of Health Informatics and PublicHealth, Tohoku University Graduate School of Medicine, Sendai, Japan.'}]",BMJ open,['10.1136/bmjopen-2018-026086'] 638,31039482,Getting to precision psychopharmacology: Combining clinical and genetic information to predict fat gain from aripiprazole.,"INTRODUCTION All atypical antipsychotics are associated with some degree of weight gain. We applied a novel statistical approach to identify moderators of aripiprazole-induced fat gain using clinical and genetic data from a randomized clinical trial (RCT) of treatment resistant depression in older adults. MATERIALS AND METHODS Adults aged ≥60 years with non-response to a prospective trial of venlafaxine were randomized to 12 weeks of aripiprazole augmentation (n = 91) or placebo (n = 90). Dual energy x-ray absorptiometry (DEXA) measured adiposity at baseline and 12 weeks. Independent moderators of total body fat gain were used to generate two combined multiple moderators, one including clinical data alone and one including both clinical and genetic data to characterize individuals who gained fat during aripiprazole augmentation. RESULTS The value of the combined genetic + clinical multiple moderator (M cg ) was 0.57 [95% CI 0.46, 0.68] (effect size: 0.57), compared to the combined clinical moderator (M c ) value of 0.49 [0.34, 0.63] (effect size: 0.49). Individuals who gained adiposity in this study were more likely to be female and younger in age, have lower weight, fasting glucose and lipids at baseline and positive for the HTR2C polymorphism. DISCUSSION These results demonstrate a combined multiple moderator approach, including both clinical and genetic moderators, can be applied to existing clinical trial data to understand adverse treatment effects. This method allowed for more specific characterization of individuals at risk for the outcome of interest. Further work is needed to identify additional genetic moderators and to validate the approach.",2019,"The value of the combined genetic + clinical multiple moderator (M cg ) was 0.57 [95% CI 0.46, 0.68] (effect size: 0.57), compared to the combined clinical moderator (M c ) value of 0.49 [0.34, 0.63] (effect size: 0.49).","['Adults aged ≥60 years with non-response to a prospective trial of', 'older adults']","['Dual energy x-ray absorptiometry (DEXA', 'placebo', 'venlafaxine', 'aripiprazole augmentation', 'aripiprazole-induced fat gain', 'aripiprazole']",[],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C1510486', 'cui_str': 'Dual X-Ray Absorptiometry'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0078569', 'cui_str': 'venlafaxine'}, {'cui': 'C0299792', 'cui_str': 'aripiprazole'}, {'cui': 'C1293122', 'cui_str': 'Augmentation procedure'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0015677', 'cui_str': 'Fats'}]",[],,0.0339439,"The value of the combined genetic + clinical multiple moderator (M cg ) was 0.57 [95% CI 0.46, 0.68] (effect size: 0.57), compared to the combined clinical moderator (M c ) value of 0.49 [0.34, 0.63] (effect size: 0.49).","[{'ForeName': 'H', 'Initials': 'H', 'LastName': 'Oughli', 'Affiliation': 'Washington University School of Medicine, Department of Psychiatry, Healthy Mind Lab, St. Louis, MO, USA.'}, {'ForeName': 'E J', 'Initials': 'EJ', 'LastName': 'Lenze', 'Affiliation': 'Washington University School of Medicine, Department of Psychiatry, Healthy Mind Lab, St. Louis, MO, USA.'}, {'ForeName': 'A E', 'Initials': 'AE', 'LastName': 'Locke', 'Affiliation': 'Washington University School of Medicine, Department of Internal Medicine, St. Louis, MO, USA.'}, {'ForeName': 'M D', 'Initials': 'MD', 'LastName': 'Yingling', 'Affiliation': 'Washington University School of Medicine, Department of Psychiatry, Healthy Mind Lab, St. Louis, MO, USA.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Zhong', 'Affiliation': 'University of Pittsburgh Graduate School of Public Health, Department of Epidemiology, Pittsburgh, PA, USA.'}, {'ForeName': 'J P', 'Initials': 'JP', 'LastName': 'Miller', 'Affiliation': 'Washington University School of Medicine, Division of Biostatistics, St. Louis, MO, USA.'}, {'ForeName': 'C F', 'Initials': 'CF', 'LastName': 'Reynolds', 'Affiliation': 'University of Pittsburgh Medical Center, Department of Psychiatry, Pittsburgh, PA, USA.'}, {'ForeName': 'B H', 'Initials': 'BH', 'LastName': 'Mulsant', 'Affiliation': 'University of Toronto, Department of Psychiatry and Center for Addiction and Mental Health, Toronto, Canada.'}, {'ForeName': 'J W', 'Initials': 'JW', 'LastName': 'Newcomer', 'Affiliation': 'Washington University School of Medicine, Department of Psychiatry, Healthy Mind Lab, St. Louis, MO, USA; Thriving Mind South Florida, Miami, FL, USA.'}, {'ForeName': 'T R', 'Initials': 'TR', 'LastName': 'Peterson', 'Affiliation': 'Washington University School of Medicine, Department of Internal Medicine, St. Louis, MO, USA.'}, {'ForeName': 'D J', 'Initials': 'DJ', 'LastName': 'Müller', 'Affiliation': 'University of Toronto, Department of Psychiatry and Center for Addiction and Mental Health, Toronto, Canada.'}, {'ForeName': 'G E', 'Initials': 'GE', 'LastName': 'Nicol', 'Affiliation': 'Washington University School of Medicine, Department of Psychiatry, Healthy Mind Lab, St. Louis, MO, USA. Electronic address: nicolg@wustl.edu.'}]",Journal of psychiatric research,['10.1016/j.jpsychires.2019.04.017'] 639,31753521,"Impact of the mental health and dynamic referral for oncology (MHADRO) program on oncology patient outcomes, health care utilization, and health provider behaviors: A multi-site randomized control trial.","OBJECTIVE The MHADRO assesses psychosocial and medical needs, provides tailored feedback reports, and connects patients to mental health providers. This study examined the MHADRO's effect on patient outcomes, health care utilization, and oncology provider documentation and behaviors. METHODS 836 patients were part of a multi-site RCT and assessments were conducted at baseline, 2, 6 and 12 months. RESULTS The intervention group engaged in less emergency calls to providers. There were no differences in psychosocial outcomes at follow up assessments. Providers of patients in the intervention group were more likely to: document psychosocial symptoms and history; refer to psychosocial services; encourage support groups; seek psychological evaluations during visits. Patients who agreed to a mental health referral had decreased hospitalizations, increased mental health care interactions, and stronger ratings of counseling potential benefits. This group also reported increased psychosocial distress at all follow-up assessments. CONCLUSION The MHADRO may increase access to mental health care, lessen utilization, and improve providers' management of psychosocial needs, but does not appear to impact overall functioning over time. PRACTICE IMPLICATIONS Providers are encouraged to consider incorporating programs, like the MHADRO, into patient care as they may have the potential to impact screening and management of patients' psychosocial needs.",2020,There were no differences in psychosocial outcomes at follow up assessments.,"['Patients who agreed to a mental health referral had decreased', '836 patients were part of a multi-site RCT and assessments were conducted at baseline, 2, 6 and 12 months', 'connects patients to mental health providers']",['mental health and dynamic referral for oncology (MHADRO) program'],"['hospitalizations, increased mental health care interactions, and stronger ratings of counseling potential benefits', 'psychosocial outcomes', 'psychosocial distress', 'health care utilization, and health provider behaviors']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0034927', 'cui_str': 'Referral'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C1292711', 'cui_str': 'Part of (attribute)'}, {'cui': 'C3266262', 'cui_str': 'Multi'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C2585524', 'cui_str': 'Referral for'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0184643', 'cui_str': 'Mental health care'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}, {'cui': 'C0442821', 'cui_str': 'Strong (qualifier value)'}, {'cui': 'C0341618', 'cui_str': 'Counsel (occupation)'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0030672', 'cui_str': 'Patient Acceptance of Healthcare'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}]",836.0,0.0295192,There were no differences in psychosocial outcomes at follow up assessments.,"[{'ForeName': 'Erin', 'Initials': 'E', 'LastName': ""O'Hea"", 'Affiliation': 'University of Massachusetts Medical School, Worcester, MA, and Department of Psychology, Stonehill University, Easton, MA, 320 Washington Street, Shields Science Center 212, Easton, MA, USA. Electronic address: Erin.ohea@umassmed.edu.'}, {'ForeName': 'Aimee', 'Initials': 'A', 'LastName': 'Kroll-Desrosiers', 'Affiliation': 'Biostatistician, Department of Quantitative Health Sciences, University of Massachusetts Medical School, Worcester, MA, USA.'}, {'ForeName': 'Alexandra S', 'Initials': 'AS', 'LastName': 'Cutillo', 'Affiliation': 'Medical/Clinical Psychology Doctoral Program, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Hannah R', 'Initials': 'HR', 'LastName': 'Michalak', 'Affiliation': ""Yale University Alzheimer's Disease Research Unit, One Church Street, Suite 600, New Haven, CT, 06510, United States.""}, {'ForeName': 'Bruce A', 'Initials': 'BA', 'LastName': 'Barton', 'Affiliation': 'Department of Quantitative Health Sciences, University of Massachusetts Medical School, Worcester, MA, USA.'}, {'ForeName': 'Tina', 'Initials': 'T', 'LastName': 'Harralson', 'Affiliation': 'Polaris Health Directions, Wayne, PA, USA.'}, {'ForeName': 'Cindy', 'Initials': 'C', 'LastName': 'Carmack', 'Affiliation': 'Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Cori', 'Initials': 'C', 'LastName': 'McMahon', 'Affiliation': 'Anderson at Cooper Cancer Center, Camden, NJ, USA.'}, {'ForeName': 'Edwin D', 'Initials': 'ED', 'LastName': 'Boudreaux', 'Affiliation': 'Departments of Emergency Medicine, Psychiatry, and Quantitative Health Sciences, University of Massachusetts Medical School, Worcester, MA, USA.'}]",Patient education and counseling,['10.1016/j.pec.2019.10.006'] 640,31765988,Dual Erb B Inhibition in Oesophago-gastric Cancer (DEBIOC): A phase I dose escalating safety study and randomised dose expansion of AZD8931 in combination with oxaliplatin and capecitabine chemotherapy in patients with oesophagogastric adenocarcinoma.,"BACKGROUND AZD8931 has equipotent activity against epidermal growth factor receptor, erbB2, and erbB3. Primary objectives were to determine the recommended phase II dose (RP2D) of AZD8931 + chemotherapy, and subsequently assess safety/preliminary clinical activity in patients with operable oesophagogastric cancer (OGC). METHODS AZD8931 (20 mg, 40 mg or 60 mg bd) was given with Xelox (oxaliplatin + capecitabine) for eight 21-day cycles, continuously or with intermittent schedule (4 days on/3 off every week; 14 days on/7 off, per cycle) in a rolling-six design. Subsequently, patients with OGC were randomised 2:1 to AZD8931 + Xelox at RP2D or Xelox only for two cycles, followed by radical oesophagogastric surgery. Secondary outcomes were safety, complete resection (R0) rate, six-month progression-free survival (PFS) and overall survival. RESULTS During escalation, four dose-limiting toxicities were observed among 24 patients: skin rash (1) and failure to deliver 100% of Xelox because of treatment-associated grade III-IV adverse events (AEs) (3: diarrhoea and vomiting; vomiting; fatigue). Serious adverse events (SAE) occurred in 15 of 24 (63%) patients. RP2D was 20-mg bd with the 4/3 schedule. In the expansion phase, 2 of 20 (10%) patients in the Xelox + AZD8931 group and 5/10 (50%) patients in the Xelox group had grade III-IV AEs. Six-month PFS was 85% (90% CI: 66%-94%) in Xelox + AZD8931 and 100% in Xelox alone. Seven deaths (35%) occurred with Xelox + AZD8931 and one (10%) with Xelox. R0 rate was 45% (9/20) with Xelox + AZD8931 and 90% (9/10) with Xelox-alone (P = 0.024). CONCLUSION Xelox + AZD8931 (20 mg bd 4/3 days) has an acceptable safety profile administered as neoadjuvant therapy in operable patients with OGC. (Trial registration: EudraCT 2011-003169-13, ISRCTN-68093791).",2020,Six-month PFS was 85% (90% CI: 66%-94%) in Xelox + AZD8931 and 100% in Xelox alone.,"['Oesophago-gastric Cancer (DEBIOC', 'patients with OGC', 'patients with operable oesophagogastric cancer (OGC', 'AZD8931 ', '24 patients', 'operable patients with OGC', 'patients with oesophagogastric adenocarcinoma']","['oxaliplatin and capecitabine chemotherapy', 'RP2D', 'AZD8931', 'Xelox (oxaliplatin\xa0+\xa0capecitabine', 'AZD8931\xa0+\xa0Xelox at RP2D or Xelox', 'Xelox\xa0+\xa0AZD8931 ']","['skin rash', 'safety/preliminary clinical activity', 'grade III-IV adverse events (AEs', 'safety, complete resection (R0) rate, six-month progression-free survival (PFS) and overall survival', 'R0 rate', 'Serious adverse events (SAE']","[{'cui': 'C0024623', 'cui_str': 'Cancer of Stomach'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205188', 'cui_str': 'Operable (qualifier value)'}, {'cui': 'C0475468', 'cui_str': 'Esophagogastric (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C2703086', 'cui_str': 'AZD8931'}, {'cui': 'C0001418', 'cui_str': 'Adenoma, Malignant'}]","[{'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C2703086', 'cui_str': 'AZD8931'}, {'cui': 'C1956962', 'cui_str': 'XELOX'}]","[{'cui': 'C0015230', 'cui_str': 'Skin Rash'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439611', 'cui_str': 'Preliminary (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",,0.0464859,Six-month PFS was 85% (90% CI: 66%-94%) in Xelox + AZD8931 and 100% in Xelox alone.,"[{'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Thomas', 'Affiliation': 'University of Leicester, Leicester, UK. Electronic address: at107@le.ac.uk.'}, {'ForeName': 'Pradeep S', 'Initials': 'PS', 'LastName': 'Virdee', 'Affiliation': 'Centre for Statistics in Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Eatock', 'Affiliation': 'Belfast City Hospital, Belfast, UK.'}, {'ForeName': 'Simon R', 'Initials': 'SR', 'LastName': 'Lord', 'Affiliation': 'University of Oxford, Oxford, UK.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Falk', 'Affiliation': 'Bristol Haematology & Oncology Centre, Bristol, UK.'}, {'ForeName': 'D Alan', 'Initials': 'DA', 'LastName': 'Anthoney', 'Affiliation': 'St. James University Hospital, Leeds, UK.'}, {'ForeName': 'Richard C', 'Initials': 'RC', 'LastName': 'Turkington', 'Affiliation': 'Centre for Cancer Research and Cell Biology, Queens University Belfast, Belfast, UK.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Goff', 'Affiliation': 'Oncology Clinical Trials Office, University of Oxford, Oxford, UK.'}, {'ForeName': 'Leena', 'Initials': 'L', 'LastName': 'Elhussein', 'Affiliation': 'Centre for Statistics in Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Collins', 'Affiliation': 'Oncology Clinical Trials Office, University of Oxford, Oxford, UK.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Love', 'Affiliation': 'Centre for Statistics in Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Moschandreas', 'Affiliation': 'Centre for Statistics in Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Mark R', 'Initials': 'MR', 'LastName': 'Middleton', 'Affiliation': 'University of Oxford, Oxford, UK; NIHR Oxford Biomedical Research Centre, UK.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2019.10.010'] 641,31774355,Cerebral blood flow responses to exercise are enhanced in left ventricular assist device patients after an exercise rehabilitation program.,"Cerebral blood flow during exercise is impaired in patients with heart failure implanted with left ventricular assist devices (LVADs). Our aim was to determine whether a 3-mo exercise training program could mitigate cerebrovascular dysfunction. Internal carotid artery (ICA) blood flow and intracranial middle (MCA v ) and posterior cerebral (PCA v ) artery velocities were measured continuously using Doppler ultrasound, alongside cardiorespiratory measures at rest and in response to an incremental cycle ergometer exercise protocol in 12 LVAD participants (5 female, 53.6 ± 11.8 yr; 84.2 ± 15.7 kg; 1.73 ± 0.08) pre- (PreTR) and post- (PostTR) completion of a 3-mo supervised exercise rehabilitation program. At rest, only PCAv was different PostTR (38.1 ± 10.4 cm/s) compared with PreTR (43.0 ± 10.8 cm/s; P < 0.05). PreTR, the reduction in PCAv observed from rest to exercise (5.2 ± 1.8%) was mitigated PostTR ( P < 0.001). Similarly, exercise training enhanced ICA flow during submaximal exercise (~8.6 ± 13.7%), resulting in increased ICA flow PostTR compared with a reduced flow PreTR ( P < 0.001). Although both end-tidal partial pressure of carbon dioxide and mean arterial pressure responses during incremental exercise were greater PostTR than PreTR, only the improved P E T C O 2 was related to the improved ICA flow ( R 2  = 0.14; P < 0.05). Our findings suggest that short-term exercise training improves cerebrovascular function during exercise in patients with LVADs. This finding should encourage future studies investigating long-term exercise training and cerebral and peripheral vascular adaptation. NEW & NOTEWORTHY Left ventricular assist devices, now used as destination therapy in end-stage heart failure, enable patients to undertake rehabilitative exercise training. We show, for the first time in humans, that training improves cerebrovascular function during exercise in patients with left ventricular assist devices. This finding may have implications for cerebrovascular health in patients with heart failure.",2020,"At rest, only PCAv was different PostTR (38.1±10.4 cm.s -1 ) compared to PreTR (43.0±10.8 cm.s -1 ; p <0.05).","['heart failure patients implanted with left ventricular assist devices (LVADs', 'patients with LVADs']","['posterior cerebral [PCAv', 'exercise training program', 'short-term exercise training', 'exercise rehabilitation program', 'supervised exercise rehabilitation program']","['artery velocities', 'PCAv', 'cerebrovascular function', 'Cerebral blood flow responses', 'ICA flow']","[{'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2828363', 'cui_str': 'Implant'}, {'cui': 'C0085842', 'cui_str': 'Artificial Ventricle'}]","[{'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}]","[{'cui': 'C0003842', 'cui_str': 'Arteries'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0428714', 'cui_str': 'Cerebral Blood Flow'}, {'cui': 'C0201519', 'cui_str': 'Antibody to islet cells of pancreas measurement (procedure)'}]",,0.0444507,"At rest, only PCAv was different PostTR (38.1±10.4 cm.s -1 ) compared to PreTR (43.0±10.8 cm.s -1 ; p <0.05).","[{'ForeName': 'Kurt J', 'Initials': 'KJ', 'LastName': 'Smith', 'Affiliation': 'Cardiovascular Research Group, School of Human Sciences (Exercise and Sport Science), The University of Western Australia, Perth, Australia.'}, {'ForeName': 'Ignacio', 'Initials': 'I', 'LastName': 'Moreno-Suarez', 'Affiliation': 'School of Physiotherapy and Exercise Science, Curtin University, Bentley, Australia.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Scheer', 'Affiliation': 'School of Physiotherapy and Exercise Science, Curtin University, Bentley, Australia.'}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Dembo', 'Affiliation': 'Allied Health Department and Advanced Heart Failure and Cardiac Transplant Service, Fiona Stanley Hospital, Murdoch, Australia.'}, {'ForeName': 'Louise H', 'Initials': 'LH', 'LastName': 'Naylor', 'Affiliation': 'Cardiovascular Research Group, School of Human Sciences (Exercise and Sport Science), The University of Western Australia, Perth, Australia.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Maiorana', 'Affiliation': 'School of Physiotherapy and Exercise Science, Curtin University, Bentley, Australia.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Green', 'Affiliation': 'Cardiovascular Research Group, School of Human Sciences (Exercise and Sport Science), The University of Western Australia, Perth, Australia.'}]","Journal of applied physiology (Bethesda, Md. : 1985)",['10.1152/japplphysiol.00604.2019'] 642,32067256,"Effect of ciclosporin on safety, lymphocyte kinetics and left ventricular remodelling in acute myocardial infarction.","AIMS Following a favourable pilot trial using a single bolus of ciclosporin, it has been unclear why 2 large studies (CYCLE and CIRCUS) failed to prevent reperfusion injury and reduce infarct size in STEMI (ST elevation myocardial infarction). The purpose of this study was to assess the effect of ciclosporin on myocardial injury, left ventricular remodelling and lymphocyte kinetics in patients with acute STEMI undergoing primary percutaneous coronary intervention. METHODS In this double-blind, single centre trial, we randomly assigned 52 acute STEMI patients with an onset of pain of <6 hours and blocked culprit artery to a single bolus of ciclosporin (n = 26) or placebo (n = 26, control group) prior to reperfusion by stent percutaneous coronary intervention. The primary endpoint was infarct size at 12 weeks. RESULTS Mean infarct size at 12 weeks was identical in both groups (9.1% [standard deviation= 7.0] vs 9.1% [standard deviation = 7.0], P = .99; 95% confidence interval for difference: -4.0 to 4.1). CD3 T-lymphocytes dropped to similar levels at 90 minutes (867 vs 852 cells/μL, control vs ciclosporin) and increased to 1454 vs 1650 cells/μL at 24 hours. CONCLUSION In our pilot trial, a single ciclosporin bolus did not affect infarct size or left ventricular remodelling, matching the results from CYCLE and CIRCUS. Our study suggests that ciclosporin does either not reach ischaemic cardiomyocytes, or requires earlier application during first medical contact. Finally, 1 bolus of ciclosporin is not sufficient to inhibit CD4 T-lymphocyte proliferation during remodelling. We therefore believe that further studies are warranted. (Evaluating the effectiveness of intravenous Ciclosporin on reducing reperfusion injury in pAtients undergoing PRImary percutaneous coronary intervention [CAPRI]; NCT02390674).",2020,"CD3 T-lymphocytes dropped to similar levels at 90 min (867 vs 852 cells/ul, control vs ciclosporin) and increased to 1454 vs 1650 cells/ul at 24h. ","['pAtients undergoing PRImary percutaneous coronary intervention [CAPRI', 'acute myocardial infarction', '52 acute STEMI patients with an onset of pain of less than 6 hours and blocked culprit artery to a single bolus of', 'n=26) or', 'patients with acute STEMI undergoing primary PCI']","['placebo', 'control group) prior to reperfusion by stent PCI', 'ciclosporin', 'Ciclosporin']","['Mean infarct size', 'infarct size at 12 weeks', 'safety, lymphocyte kinetics and left ventricular remodelling', 'infarct size or LV remodelling', 'CD3 T-lymphocytes', 'myocardial injury, LV-remodelling, and lymphocyte kinetics']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}, {'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction (disorder)'}, {'cui': 'C1536220', 'cui_str': 'ST Elevated Myocardial Infarction'}, {'cui': 'C0332162', 'cui_str': 'Onset of (contextual qualifier) (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1292428', 'cui_str': '6 hours (qualifier value)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0003842', 'cui_str': 'Arteries'}, {'cui': 'C1301654', 'cui_str': 'Single bolus (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0035124', 'cui_str': 'Reperfusion'}, {'cui': 'C0038257', 'cui_str': 'Stents'}, {'cui': 'C0010592', 'cui_str': 'cyclosporine A'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0021308', 'cui_str': 'Infarction'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C4018897', 'cui_str': 'Lymphocyte component of blood'}, {'cui': 'C0022702', 'cui_str': 'Kinetics'}, {'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}, {'cui': 'C0600519', 'cui_str': 'Myocardial Remodeling, Ventricular'}, {'cui': 'C0039194', 'cui_str': 'Thymus-Dependent Lymphocytes'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}]",52.0,0.597496,"CD3 T-lymphocytes dropped to similar levels at 90 min (867 vs 852 cells/ul, control vs ciclosporin) and increased to 1454 vs 1650 cells/ul at 24h. ","[{'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Cormack', 'Affiliation': 'Freeman Hospital, Newcastle upon Tyne, UK.'}, {'ForeName': 'Ashfaq', 'Initials': 'A', 'LastName': 'Mohammed', 'Affiliation': 'Freeman Hospital, Newcastle upon Tyne, UK.'}, {'ForeName': 'Pedram', 'Initials': 'P', 'LastName': 'Panahi', 'Affiliation': 'Freeman Hospital, Newcastle upon Tyne, UK.'}, {'ForeName': 'Rajiv', 'Initials': 'R', 'LastName': 'Das', 'Affiliation': 'Freeman Hospital, Newcastle upon Tyne, UK.'}, {'ForeName': 'Alison J', 'Initials': 'AJ', 'LastName': 'Steel', 'Affiliation': 'Newcastle Clinical Trials Unit, Faculty of Medical Sciences, Newcastle University, UK.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Chadwick', 'Affiliation': 'Population Health Sciences Institute, Newcastle University, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Bryant', 'Affiliation': 'Population Health Sciences Institute, Newcastle University, UK.'}, {'ForeName': 'Mohaned', 'Initials': 'M', 'LastName': 'Egred', 'Affiliation': 'Freeman Hospital, Newcastle upon Tyne, UK.'}, {'ForeName': 'Konstantinos', 'Initials': 'K', 'LastName': 'Stellos', 'Affiliation': 'Freeman Hospital, Newcastle upon Tyne, UK.'}, {'ForeName': 'Ioakim', 'Initials': 'I', 'LastName': 'Spyridopoulos', 'Affiliation': 'Freeman Hospital, Newcastle upon Tyne, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",British journal of clinical pharmacology,['10.1111/bcp.14252'] 643,31213445,"Individualised screening for diabetic retinopathy: the ISDR study-rationale, design and methodology for a randomised controlled trial comparing annual and individualised risk-based variable-interval screening.","INTRODUCTION Currently, all people with diabetes (PWD) aged 12 years and over in the UK are invited for screening for diabetic retinopathy (DR) annually. Resources are not increasing despite a 5% increase in the numbers of PWD nationwide each year. We describe the rationale, design and methodology for a randomised controlled trial (RCT) evaluating the safety, acceptability and cost-effectiveness of personalised variable-interval risk-based screening for DR. This is the first randomised trial of personalised screening for DR and the largest ophthalmic RCT in the UK. METHODS AND ANALYSIS PWD attending seven screening clinics in the Liverpool Diabetic Eye Screening Programme were recruited into a single site RCT with a 1:1 allocation to individualised risk-based variable-interval or annual screening intervals. A risk calculation engine developed for the trial estimates the probability that an individual will develop referable disease (screen positive DR) within the next 6, 12 or 24 months using demographic, retinopathy and systemic risk factor data from primary care and screening programme records. Dynamic, secure, real-time data connections have been developed. The primary outcome is attendance for follow-up screening. We will test for equivalence in attendance rates between the two arms. Secondary outcomes are rates and severity of DR, visual outcomes, cost-effectiveness and health-related quality of life. The required sample size was 4460 PWD. Recruitment is complete, and the trial is in follow-up. ETHICS AND DISSEMINATION Ethical approval was obtained from National Research Ethics Service Committee North West - Preston, reference 14/NW/0034. Results will be presented at international meetings and published in peer-reviewed journals. This pragmatic RCT will inform screening policy in the UK and elsewhere. TRIAL REGISTRATION NUMBER ISRCTN87561257; Pre-results.",2019,"Currently, all people with diabetes (PWD) aged 12 years and over in the UK are invited for screening for diabetic retinopathy (DR) annually.","['PWD attending seven screening clinics in the Liverpool Diabetic Eye Screening Programme', 'diabetic retinopathy', 'people with diabetes (PWD) aged 12 years and over in the UK are invited for screening for diabetic retinopathy (DR) annually']","['RCT with a 1:1 allocation to individualised risk-based variable-interval or annual screening intervals', 'Individualised screening', 'personalised variable-interval risk-based screening for DR']","['safety, acceptability and cost-effectiveness', 'attendance rates', 'rates and severity of DR, visual outcomes, cost-effectiveness and health-related quality of life', 'attendance for follow-up screening']","[{'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0011884', 'cui_str': 'Diabetic Retinopathy'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}]",,0.406542,"Currently, all people with diabetes (PWD) aged 12 years and over in the UK are invited for screening for diabetic retinopathy (DR) annually.","[{'ForeName': 'Deborah M', 'Initials': 'DM', 'LastName': 'Broadbent', 'Affiliation': 'Department of Eye and Vision Science, Institute of Ageing and Chronic Disease, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Sampson', 'Affiliation': 'Division of Rehabilitation and Ageing, School of Medicine, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Amu', 'Initials': 'A', 'LastName': 'Wang', 'Affiliation': 'Department of Eye and Vision Science, Institute of Ageing and Chronic Disease, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Lola', 'Initials': 'L', 'LastName': 'Howard', 'Affiliation': 'Department of Biostatistics, Clinical Trials Research Centre, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Abigail E', 'Initials': 'AE', 'LastName': 'Williams', 'Affiliation': 'Department of Biostatistics, Clinical Trials Research Centre, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Susan U', 'Initials': 'SU', 'LastName': 'Howlin', 'Affiliation': 'Department of Biostatistics, Clinical Trials Research Centre, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Duncan', 'Initials': 'D', 'LastName': 'Appelbe', 'Affiliation': 'Department of Biostatistics, Clinical Trials Research Centre, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Tracy', 'Initials': 'T', 'LastName': 'Moitt', 'Affiliation': 'Department of Biostatistics, Clinical Trials Research Centre, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Christopher P', 'Initials': 'CP', 'LastName': 'Cheyne', 'Affiliation': 'Department of Biostatistics, Clinical Trials Research Centre, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Mehrdad Mobayen', 'Initials': 'MM', 'LastName': 'Rahni', 'Affiliation': 'Department of Eye and Vision Science, Institute of Ageing and Chronic Disease, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Kelly', 'Affiliation': 'Patient and Public Involvement Group, Liverpool, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Collins', 'Affiliation': 'Patient and Public Involvement Group, Liverpool, UK.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'García-Fiñana', 'Affiliation': 'Department of Biostatistics, Clinical Trials Research Centre, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Irene M', 'Initials': 'IM', 'LastName': 'Stratton', 'Affiliation': 'Gloucestershire Retinal Research Group, Cheltenham General Hospital, Cheltenham, UK.'}, {'ForeName': 'Marilyn', 'Initials': 'M', 'LastName': 'James', 'Affiliation': 'Division of Rehabilitation and Ageing, School of Medicine, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Simon P', 'Initials': 'SP', 'LastName': 'Harding', 'Affiliation': 'Department of Eye and Vision Science, Institute of Ageing and Chronic Disease, University of Liverpool, Liverpool, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ open,['10.1136/bmjopen-2018-025788'] 644,31083056,Blended Collaborative Care to Treat Heart Failure and Comorbid Depression: Rationale and Study Design of the Hopeful Heart Trial.,"OBJECTIVE Despite numerous improvements in care, morbidity from heart failure (HF) has remained essentially unchanged in recent years. One potential reason is that depression, which is comorbid in approximately 40% of hospitalized HF patients and associated with adverse HF outcomes, often goes unrecognized and untreated. The Hopeful Heart Trial is the first study to evaluate whether a widely generalizable telephone-delivered collaborative care program for treating depression in HF patients improves clinical outcomes. METHODS The Hopeful Heart Trial aimed to enroll 750 patients with reduced ejection fraction (HFrEF) (ejection fraction ≤ 45%) including the following: (A) 625 patients who screened positive for depression both during their hospitalization (Patient Health Questionnaire [PHQ-2]) and two weeks following discharge (PHQ-9 ≥ 10); and (B) 125 non-depressed control patients (PHQ-2(-)/PHQ-9 < 5). We randomized depressed patients to either their primary care physician's ""usual care"" (UC) or to one of two nurse-delivered 12-month collaborative care programs for (a) depression and HFrEF (""blended"") or (b) HrEFF alone (enhanced UC). Our co-primary hypotheses will test whether ""blended"" care can improve mental health-related quality of life versus UC and versus enhanced UC, respectively, on the Mental Component Summary of the Short-Form 12 Health Survey. Secondary hypotheses will evaluate the effectiveness of our interventions on mood, functional status, hospital readmissions, deaths, provision of evidence-based care for HFrEF, and treatment costs. RESULTS Not applicable. CONCLUSIONS The Hopeful Heart Trial will determine whether ""blended"" collaborative care for depression and HFrEF is more effective at improving patient-relevant outcomes than collaborative care for HFrEF alone or doctors' UC for HFrEF. TRIAL REGISTRATION ClinicalTrials.gov identifier NCT02044211.",2019,"Our co-primary hypotheses will test whether ""blended"" care can improve mental health-related quality of life versus UC and versus enhanced UC, respectively, on the Mental Component Summary of the Short-Form 12 Health Survey.","['depressed patients to either their primary care physician\'s ""usual care"" (UC) or to one of two nurse-delivered 12-month', '750 patients with reduced ejection fraction (HFrEF) (ejection fraction ≤ 45%) including the following: (A) 625 patients who screened positive for depression both during their hospitalization (Patient Health Questionnaire [PHQ-2]) and two weeks following discharge (PHQ-9 ≥ 10); and (B) 125 non-depressed control patients (PHQ-2(-)/PHQ-9 < 5']","['Blended Collaborative Care', 'collaborative care programs for (a) depression and HFrEF (""blended"") or (b) HrEFF alone (enhanced UC', 'generalizable telephone-delivered collaborative care program']","['mood, functional status, hospital readmissions, deaths, provision of evidence-based care for HFrEF, and treatment costs']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0033131', 'cui_str': 'Primary Care Physicians'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C4517868', 'cui_str': '750 (qualifier value)'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C4517838', 'cui_str': 'Six hundred and twenty-five'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C1879301', 'cui_str': 'Patient Health Questionnaire'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C4082118', 'cui_str': 'Two weeks'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}]","[{'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0600290', 'cui_str': 'Hospital Readmissions'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0087112', 'cui_str': 'Treatment Costs'}]",750.0,0.153453,"Our co-primary hypotheses will test whether ""blended"" care can improve mental health-related quality of life versus UC and versus enhanced UC, respectively, on the Mental Component Summary of the Short-Form 12 Health Survey.","[{'ForeName': 'Bea', 'Initials': 'B', 'LastName': 'Herbeck Belnap', 'Affiliation': 'From the Division of General Internal Medicine (Herbeck Belnap, Anderson, Abebe, Rollman), and Center for Behavioral Health and Smart Technology (Herbeck Belnap, Anderson, Rollman), University of Pittsburgh School of Medicine, Pittsburgh, PA; Department of Psychosomatic Medicine and Psychotherapy (Herbeck Belnap), University of Göttingen Medical Center, Göttingen, Germany; and Center for Clinical Trials & Data Coordination (Abebe), Cardiovascular Institute (Ramani, Muldoon), and Department of Psychiatry (Karp), University of Pittsburgh School of Medicine, Pittsburgh, PA. www.healthtech.pitt.edu and @HealthTechPitt.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Anderson', 'Affiliation': ''}, {'ForeName': 'Kaleab Z', 'Initials': 'KZ', 'LastName': 'Abebe', 'Affiliation': ''}, {'ForeName': 'Ravi', 'Initials': 'R', 'LastName': 'Ramani', 'Affiliation': ''}, {'ForeName': 'Matthew F', 'Initials': 'MF', 'LastName': 'Muldoon', 'Affiliation': ''}, {'ForeName': 'Jordan F', 'Initials': 'JF', 'LastName': 'Karp', 'Affiliation': ''}, {'ForeName': 'Bruce L', 'Initials': 'BL', 'LastName': 'Rollman', 'Affiliation': ''}]",Psychosomatic medicine,['10.1097/PSY.0000000000000706'] 645,31084291,Predictors of Hospitalization of Individuals With First-Episode Psychosis: Data From a 2-Year Follow-Up of the RAISE-ETP.,"OBJECTIVE Despite treatment advances in other domains, inpatient psychiatric hospitalization rates for individuals with first-episode psychosis remain high. Even with early intervention services, a third or more of individuals are hospitalized over the first 2 years of treatment. Reducing hospitalization is desirable from the individual's perspective and for public health reasons because hospitalization costs are a major component of treatment costs. METHODS Univariate and multivariate baseline and time-varying covariate analyses were conducted to identify predictors of hospitalization in the Recovery After an Initial Schizophrenia Episode-Early Treatment Program (RAISE-ETP) study, a 2-year cluster randomized trial for participants experiencing a first episode of psychosis who were outpatients at study entry. The trial compared an early intervention treatment model (NAVIGATE) with usual community care at 34 clinics across the United States. RESULTS RAISE-ETP enrolled 404 participants of whom 382 had one or more postbaseline assessments that included hospitalization data. Thirty-four percent of NAVIGATE and 37% of usual-care participants were hospitalized during the trial. Risk analyses revealed significant predictors of hospitalization to be the number of hospitalizations before study entry; duration of untreated psychosis; and time-varying days of substance misuse, presence of positive symptoms, and beliefs about the value of medication. CONCLUSIONS These results indicate that hospital use may be decreased by reducing the duration of untreated psychosis and prior hospitalizations, minimizing residual symptoms, preventing substance misuse, and facilitating adherence to medication taking. Addressing these factors could enhance the impact of first-episode early intervention treatment models and also enhance outcomes of people with first-episode psychosis treated using other models.",2019,"Risk analyses revealed significant predictors of hospitalization to be the number of hospitalizations before study entry; duration of untreated psychosis; and time-varying days of substance misuse, presence of positive symptoms, and beliefs about the value of medication. ","['Individuals With First-Episode Psychosis', 'participants experiencing a first episode of psychosis who were outpatients at study entry', 'Thirty-four percent of NAVIGATE and 37% of usual-care participants were hospitalized during the trial', 'individuals with first-episode psychosis remain high', '404 participants of whom 382 had one or more postbaseline assessments that included hospitalization data']",['early intervention treatment model (NAVIGATE) with usual community care at 34 clinics across the United States'],[],"[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0439615', 'cui_str': 'First episode (qualifier value)'}, {'cui': 'C0033975', 'cui_str': 'Psychoses'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0439165', 'cui_str': 'Percent (property) (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C4517750', 'cui_str': 'Three hundred and eighty-two'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}]","[{'cui': 'C0242687', 'cui_str': 'Early Intervention'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}]",[],404.0,0.0180821,"Risk analyses revealed significant predictors of hospitalization to be the number of hospitalizations before study entry; duration of untreated psychosis; and time-varying days of substance misuse, presence of positive symptoms, and beliefs about the value of medication. ","[{'ForeName': 'Delbert G', 'Initials': 'DG', 'LastName': 'Robinson', 'Affiliation': 'Department of Psychiatry, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Hempstead, New York, Feinstein Institute for Medical Research, Manhasset, New York (Robinson, Kane); Department of Psychiatry, SUNY Downstate Medical Center, Brooklyn, New York (Schooler); Department of Psychiatry, Yale School of Medicine, New Haven, Connecticut (Rosenheck); Yale School of Public Health, New Haven (Lin, Sint); Vanguard Research Group, Glen Oaks, New York (Marcy).'}, {'ForeName': 'Nina R', 'Initials': 'NR', 'LastName': 'Schooler', 'Affiliation': 'Department of Psychiatry, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Hempstead, New York, Feinstein Institute for Medical Research, Manhasset, New York (Robinson, Kane); Department of Psychiatry, SUNY Downstate Medical Center, Brooklyn, New York (Schooler); Department of Psychiatry, Yale School of Medicine, New Haven, Connecticut (Rosenheck); Yale School of Public Health, New Haven (Lin, Sint); Vanguard Research Group, Glen Oaks, New York (Marcy).'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Rosenheck', 'Affiliation': 'Department of Psychiatry, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Hempstead, New York, Feinstein Institute for Medical Research, Manhasset, New York (Robinson, Kane); Department of Psychiatry, SUNY Downstate Medical Center, Brooklyn, New York (Schooler); Department of Psychiatry, Yale School of Medicine, New Haven, Connecticut (Rosenheck); Yale School of Public Health, New Haven (Lin, Sint); Vanguard Research Group, Glen Oaks, New York (Marcy).'}, {'ForeName': 'Haiqun', 'Initials': 'H', 'LastName': 'Lin', 'Affiliation': 'Department of Psychiatry, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Hempstead, New York, Feinstein Institute for Medical Research, Manhasset, New York (Robinson, Kane); Department of Psychiatry, SUNY Downstate Medical Center, Brooklyn, New York (Schooler); Department of Psychiatry, Yale School of Medicine, New Haven, Connecticut (Rosenheck); Yale School of Public Health, New Haven (Lin, Sint); Vanguard Research Group, Glen Oaks, New York (Marcy).'}, {'ForeName': 'Kyaw J', 'Initials': 'KJ', 'LastName': 'Sint', 'Affiliation': 'Department of Psychiatry, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Hempstead, New York, Feinstein Institute for Medical Research, Manhasset, New York (Robinson, Kane); Department of Psychiatry, SUNY Downstate Medical Center, Brooklyn, New York (Schooler); Department of Psychiatry, Yale School of Medicine, New Haven, Connecticut (Rosenheck); Yale School of Public Health, New Haven (Lin, Sint); Vanguard Research Group, Glen Oaks, New York (Marcy).'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Marcy', 'Affiliation': 'Department of Psychiatry, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Hempstead, New York, Feinstein Institute for Medical Research, Manhasset, New York (Robinson, Kane); Department of Psychiatry, SUNY Downstate Medical Center, Brooklyn, New York (Schooler); Department of Psychiatry, Yale School of Medicine, New Haven, Connecticut (Rosenheck); Yale School of Public Health, New Haven (Lin, Sint); Vanguard Research Group, Glen Oaks, New York (Marcy).'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Kane', 'Affiliation': 'Department of Psychiatry, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Hempstead, New York, Feinstein Institute for Medical Research, Manhasset, New York (Robinson, Kane); Department of Psychiatry, SUNY Downstate Medical Center, Brooklyn, New York (Schooler); Department of Psychiatry, Yale School of Medicine, New Haven, Connecticut (Rosenheck); Yale School of Public Health, New Haven (Lin, Sint); Vanguard Research Group, Glen Oaks, New York (Marcy).'}]","Psychiatric services (Washington, D.C.)",['10.1176/appi.ps.201800511'] 646,31734069,Thermal ablation versus cryotherapy or loop excision to treat women positive for cervical precancer on visual inspection with acetic acid test: pilot phase of a randomised controlled trial.,"BACKGROUND Cryotherapy is standard practice for treating patients with cervical precancer in see-and-treat programmes in low-income and middle-income countries (LMICs). Because of logistical difficulties with cryotherapy (eg, the necessity, costs, and supply chain difficulties of refrigerant gas; equipment failure; and treatment duration >10 min), a battery-operated thermal ablator that is lightweight and portable has been developed. We aimed to compare thermal ablation using the new device with cryotherapy. METHODS We report the pilot phase of a randomised controlled trial in routine screen-and-treat clinics providing cervical screening using visual inspection with acetic acid (VIA) in Lusaka, Zambia. We recruited non-pregnant women, aged 25 years or older, who were eligible for ablative therapy. We randomly assigned participants (1:1:1) to thermal ablation, cryotherapy, or large loop excision of the transformation zone (LLETZ), using computer-generated allocation. The randomisation was concealed but the nurses providing treatment and the participants were unmasked. Thermal ablation was achieved using the Liger thermal ablator (using 1-5 overlapping applications of the probe heated to 100°C, each application lasting for 40 s), cryotherapy was carried out using the double-freeze technique (freeze for 3 min, thaw for 5 min, and freeze again for 3 min), and LLETZ (using a large loop driven by an electro-surgical unit to excise the transformation zone) was done under local anaesthesia. The primary endpoint was treatment success, defined as either human papillomavirus (HPV) type-specific clearance among participants who were positive for the same HPV type at baseline, or a negative VIA test at 6-month follow-up, if the baseline HPV test was negative. Per protocol analyses were done. Enrolment for the full trial is ongoing. Here, we present findings from a prespecified pilot phase of the full trial. The final analysis of the full trial will assess non-inferiority of the groups for the primary efficacy endpoint. The study is registered with ClinicalTrials.gov, number NCT02956239. FINDINGS Between Aug 2, 2017, and Jan 15, 2019, 750 participants were randomly assigned (250 per group). 206 (84%) participants in the cryotherapy group, 197 (81%) in the thermal ablation group, and 204 (84%) in the LLETZ group attended the 6-month follow-up examination. Treatment success was reported in 120 (60%) of 200 participants in the cryotherapy group, 123 (64%) of 192 in the thermal ablation group, and 134 (67%) of 199 in the LLETZ group (p=0·31). Few participants complained of moderate to severe pain in any group immediately after the procedure (six [2%] of 250 in the cryotherapy group, four [2%] of 250 in the thermal ablation group, and five [2%] of 250 in the LLETZ group) and 2 weeks after the procedure (one [<1%] of 241 in the cryotherapy group, none of 242 in the thermal ablation group, and two [<1%] of 237 in the LLETZ group). None of the participants reported any complication requiring medical consultation or admission to hospital. INTERPRETATION Results from this pilot study preliminarily suggest that thermal ablation has similar treatment success to cryotherapy, without the practical disadvantages of providing cryotherapy in an LMIC. However, the study was not powered to establish the similarity between the techniques, and results from the ongoing randomised controlled trial are need to confirm these results. FUNDING US National Institutes of Health.",2020,"Treatment success was reported in 120 (60%) of 200 participants in the cryotherapy group, 123 (64%) of 192 in the thermal ablation group, and 134 (67%) of 199 in the LLETZ group (p=0·31).","['Between Aug 2, 2017, and Jan 15, 2019', '750 participants', 'recruited non-pregnant women, aged 25 years or older, who were eligible for ablative therapy', 'patients with cervical precancer in see-and-treat programmes in low-income and middle-income countries (LMICs']","['Thermal ablation versus cryotherapy or loop excision', 'thermal ablation, cryotherapy, or large loop excision of the transformation zone (LLETZ), using computer-generated allocation', 'routine screen-and-treat clinics providing cervical screening using visual inspection with acetic acid (VIA', 'LLETZ']","['treatment success, defined as either human papillomavirus (HPV) type-specific clearance', 'severe pain', 'complication requiring medical consultation or admission to hospital', 'Treatment success']","[{'cui': 'C4517868', 'cui_str': '750 (qualifier value)'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205064', 'cui_str': 'Cervical (qualifier value)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0302604', 'cui_str': 'Low income'}, {'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}]","[{'cui': 'C0677798', 'cui_str': 'Thermal ablation'}, {'cui': 'C4551716', 'cui_str': 'Cryotherapy'}, {'cui': 'C0445022', 'cui_str': 'Loop (qualifier value)'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C3714584', 'cui_str': 'Transformation, function (observable entity)'}, {'cui': 'C0009622', 'cui_str': 'Computers'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0205064', 'cui_str': 'Cervical (qualifier value)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0199219', 'cui_str': 'Visual observation'}, {'cui': 'C0766298', 'cui_str': '(methylsulfanyl)acetic acid'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}, {'cui': 'C0278140', 'cui_str': 'Severe pain (finding)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission (procedure)'}]",750.0,0.164652,"Treatment success was reported in 120 (60%) of 200 participants in the cryotherapy group, 123 (64%) of 192 in the thermal ablation group, and 134 (67%) of 199 in the LLETZ group (p=0·31).","[{'ForeName': 'Leeya F', 'Initials': 'LF', 'LastName': 'Pinder', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Washington, Seattle, WA, USA; Obstetrics and Gynecology, University of Zambia, Lusaka, Zambia.'}, {'ForeName': 'Groesbeck P', 'Initials': 'GP', 'LastName': 'Parham', 'Affiliation': 'Obstetrics and Gynecology, University of Zambia, Lusaka, Zambia; Department of Obstetrics and Gynecology, University of North Carolina, Chapel Hill, NC, USA.'}, {'ForeName': 'Partha', 'Initials': 'P', 'LastName': 'Basu', 'Affiliation': 'Screening Group, Early Detection and Prevention Section, International Agency for Research on Cancer, WHO, Lyon, France. Electronic address: basup@iarc.fr.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Muwonge', 'Affiliation': 'Screening Group, Early Detection and Prevention Section, International Agency for Research on Cancer, WHO, Lyon, France.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Lucas', 'Affiliation': 'Screening Group, Early Detection and Prevention Section, International Agency for Research on Cancer, WHO, Lyon, France.'}, {'ForeName': 'Namakau', 'Initials': 'N', 'LastName': 'Nyambe', 'Affiliation': 'UNC Global Project-Zambia, Lusaka, Zambia.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Sauvaget', 'Affiliation': 'Screening Group, Early Detection and Prevention Section, International Agency for Research on Cancer, WHO, Lyon, France.'}, {'ForeName': 'Mulindi H', 'Initials': 'MH', 'LastName': 'Mwanahamuntu', 'Affiliation': 'Department of Obstetrics and Gynecology, Women and Newborn Hospital, University of Zambia, Lusaka, Zambia.'}, {'ForeName': 'Rengaswamy', 'Initials': 'R', 'LastName': 'Sankaranarayanan', 'Affiliation': 'Research Triangle Institute, International-India, Commercial Tower, Pullman Hotel Aerocity, New Delhi, India.'}, {'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Prendiville', 'Affiliation': 'Screening Group, Early Detection and Prevention Section, International Agency for Research on Cancer, WHO, Lyon, France.'}]",The Lancet. Oncology,['10.1016/S1470-2045(19)30635-7'] 647,31287336,"Feasibility, Acceptability, and Preliminary Efficacy of a Brief Online Sexual Health Program for Adolescents.","This study evaluated the feasibility, acceptability, and preliminary efficacy of a 45-minute interactive, online sexual health program for adolescents, called Health Education and Relationship Training (HEART). The program was originally developed and evaluated among adolescent girls (HEART for Girls); the current project describes and evaluates a new version of the program that was adapted for boys and girls. Participants were 226 high school students (mean age = 16.3; 58% girls; 46% White; 79% heterosexual). Students were randomized to HEART or an attention-matched control and assessed at pre-test and immediate post-test. Overall, the program was feasible to administer in a school setting and youth found the program highly acceptable (83% liked the program, 87% learned new things, and 93% would use program content in the future). At post-test, students who completed HEART demonstrated improvements on every outcome we examined: sexual communication intentions, condom use intentions, HIV/STD knowledge, condom attitudes, condom norms, self-efficacy to practice safer sex, and sexual assertiveness compared to control participants (effect size ds = .23 to 1.27). Interactions by gender and sexual orientation revealed the program was equally acceptable and worked equally well for boys and girls and for heterosexual and sexual minority youth. We propose several avenues to further adapt and tailor HEART given its promise in promoting adolescent sexual health.",2020,Interactions by gender and sexual orientation revealed the program was equally acceptable and worked equally well for boys and girls and for heterosexual and sexual minority youth.,"['Participants were 226 high school students (mean age\xa0=\xa016.3; 58% girls; 46% White; 79% heterosexual', 'boys and girls and for heterosexual and sexual minority youth', 'adolescents, called Health Education and Relationship Training (HEART', 'Adolescents', 'adolescent girls (HEART for Girls']","['45-minute interactive, online sexual health program', 'Brief Online Sexual Health Program', 'HEART or an attention-matched control and assessed at pre-test and immediate post-test']","['sexual communication intentions, condom use intentions, HIV/STD knowledge, condom attitudes, condom norms, self-efficacy to practice safer sex, and sexual assertiveness']","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C1527360', 'cui_str': 'Heterosexuals'}, {'cui': 'C0870221', 'cui_str': 'Boys'}, {'cui': 'C4277573', 'cui_str': 'Sexual and Gender Minorities'}, {'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0018701'}, {'cui': 'C0439849', 'cui_str': 'Relationships (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0018787', 'cui_str': 'Heart'}]","[{'cui': 'C1442463', 'cui_str': 'Forty-five minutes (qualifier value)'}, {'cui': 'C2362326', 'cui_str': 'Sexual Health'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0018787', 'cui_str': 'Heart'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}]","[{'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0009653', 'cui_str': 'Condoms'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0597728', 'cui_str': 'Responsible Sex'}, {'cui': 'C0004077', 'cui_str': 'Assertivenesses'}]",226.0,0.0135252,Interactions by gender and sexual orientation revealed the program was equally acceptable and worked equally well for boys and girls and for heterosexual and sexual minority youth.,"[{'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Widman', 'Affiliation': 'Department of Psychology, North Carolina State University.'}, {'ForeName': 'Kristyn', 'Initials': 'K', 'LastName': 'Kamke', 'Affiliation': 'Department of Psychology, North Carolina State University.'}, {'ForeName': 'Reina', 'Initials': 'R', 'LastName': 'Evans', 'Affiliation': 'Department of Psychology, North Carolina State University.'}, {'ForeName': 'J L', 'Initials': 'JL', 'LastName': 'Stewart', 'Affiliation': 'Department of Psychology, North Carolina State University.'}, {'ForeName': 'Sophia', 'Initials': 'S', 'LastName': 'Choukas-Bradley', 'Affiliation': 'Department of Psychology, University of Pittsburgh.'}, {'ForeName': 'Carol E', 'Initials': 'CE', 'LastName': 'Golin', 'Affiliation': 'School of Medicine, University of North Carolina, Chapel Hill.'}]",Journal of sex research,['10.1080/00224499.2019.1630800'] 648,31317322,Utility of a smartphone-enabled otoscope in the instruction of otoscopy and middle ear anatomy.,"PURPOSE To present the utility of a smartphone-enabled otoscope as a teaching adjunct in pre-clinical otoscopy training. METHODS 60 pre-clinical medical students were randomized into either a control group using a conventional otoscope or an experimental group using a smartphone-enabled otoscope. Participants in each group were trained to use their assigned device and were given time to practice on a colleague's ear. Participants then completed a questionnaire indicating their ability to visualize anatomical landmarks of the middle ear as well as their confidence in performing a middle ear examination using their device. RESULTS Compared to participants using the conventional otoscope, significantly more students using the smartphone-enabled otoscope identified the umbo (93% versus 63%, P = 0.005), the short process of the malleus (67% versus 33%, P = 0.008), the cone of light (100% versus 70%, P = 0.001), and the pars flaccida (60% versus 33%, P = 0.03). Furthermore, participants who used the smartphone-enabled otoscope reported significantly increased confidence in performing otoscopy compared to those who used a conventional otoscope (4.1 ± 0.7 versus 2.8 ± 0.9, P < 0.001). Finally, participants rated the smartphone-enabled otoscope as an excellent teaching aid for otoscopy training. CONCLUSION The smartphone-enabled otoscope serves as a valuable teaching tool for pre-clinical otoscopy education. After using the device, pre-clinical students were more confident in performing a middle ear examination and in identifying important anatomical landmarks of the middle ear.",2019,"Compared to participants using the conventional otoscope, significantly more students using the smartphone-enabled otoscope identified the umbo (93% versus 63%, P = 0.005), the short process of the malleus (67% versus 33%, P = 0.008), the cone of light (100% versus 70%, P = 0.001), and the pars flaccida (60% versus 33%, P = 0.03).",['60 pre-clinical medical students'],"['smartphone-enabled otoscope', 'conventional otoscope or an experimental group using a smartphone-enabled otoscope']","['confidence in performing otoscopy', 'pars flaccida', 'cone of light']","[{'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0038495', 'cui_str': 'Students, Medical'}]","[{'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0562342', 'cui_str': 'Empowered (finding)'}, {'cui': 'C0182098', 'cui_str': 'Otoscopes'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0237529', 'cui_str': 'Self Confidence'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0847244', 'cui_str': 'Otoscopy'}, {'cui': 'C0393983', 'cui_str': 'Cerebellar Herniation'}, {'cui': 'C0332264', 'cui_str': 'Light (weight) (qualifier value)'}]",60.0,0.0256622,"Compared to participants using the conventional otoscope, significantly more students using the smartphone-enabled otoscope identified the umbo (93% versus 63%, P = 0.005), the short process of the malleus (67% versus 33%, P = 0.008), the cone of light (100% versus 70%, P = 0.001), and the pars flaccida (60% versus 33%, P = 0.03).","[{'ForeName': 'Amir A', 'Initials': 'AA', 'LastName': 'Hakimi', 'Affiliation': 'Chicago Medical School at Rosalind Franklin University of Medicine and Science, 3333 Green Bay Road, North Chicago, IL, 60064, USA. amir.hakimi@my.rfums.org.'}, {'ForeName': 'Aaron S', 'Initials': 'AS', 'LastName': 'Lalehzarian', 'Affiliation': 'Chicago Medical School at Rosalind Franklin University of Medicine and Science, 3333 Green Bay Road, North Chicago, IL, 60064, USA.'}, {'ForeName': 'Simon P', 'Initials': 'SP', 'LastName': 'Lalehzarian', 'Affiliation': 'Chicago Medical School at Rosalind Franklin University of Medicine and Science, 3333 Green Bay Road, North Chicago, IL, 60064, USA.'}, {'ForeName': 'Ariel M', 'Initials': 'AM', 'LastName': 'Azhdam', 'Affiliation': 'Chicago Medical School at Rosalind Franklin University of Medicine and Science, 3333 Green Bay Road, North Chicago, IL, 60064, USA.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Nedjat-Haiem', 'Affiliation': 'University of California, Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Benjamin D', 'Initials': 'BD', 'LastName': 'Boodaie', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}]",European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery,['10.1007/s00405-019-05559-6'] 649,31373166,Six weeks of high-intensity interval training to exhaustion attenuates dynamic cerebral autoregulation without influencing resting cerebral blood velocity in young fit men.,"Elevated cardiorespiratory fitness (CRF) is associated with reduced dynamic cerebral autoregulation (dCA), but the impact of exercise training per se on dCA remains equivocal. In addition, resting cerebral blood flow (CBF) and dCA after high-intensity interval training (HIIT) in individuals with already high CRF remains unknown. We examined to what extent 6 weeks of HIIT affect resting CBF and dCA in cardiorespiratory fit men and explored if potential changes are intensity-dependent. Endurance-trained men were assigned to group HIIT 85 (85% of maximal aerobic power, 1-7 min effort bouts, n = 8) and HIIT 115 (115% of maximal aerobic power, 30 sec to 1 min effort bouts, n = 9). Training sessions were completed until exhaustion 3 times/week over 6 weeks. Mean arterial pressure (MAP) and middle cerebral artery mean blood velocity (MCAv mean ) were measured continuously at rest and during repeated squat-stands (0.05 and 0.10 Hz). Transfer function analysis (TFA) was used to characterize dCA on driven blood pressure oscillations during repeated squat-stands. Neither training nor intensity had an effect on resting MAP and MCAv mean (both P > 0.05). TFA phase during 0.10 Hz squat-stands decreased after HIIT irrespective of intensity (HIIT 85 : 0.77 ± 0.22 vs. 0.67 ± 0.18 radians; HIIT 115 : pre: 0.62 ± 0.19 vs. post: 0.59 ± 0.13 radians, time effect P = 0.048). These results suggest that HIIT over 6 weeks have no apparent benefits on resting CBF, but a subtle attenuation in dCA is seen posttraining irrespective of intensity training in endurance-trained men.",2019,Neither training nor intensity had an effect on resting MAP and MCAv mean (both P > 0.05).,"['endurance-trained men', 'young fit men', 'Endurance-trained men']",[],"['blood pressure oscillations', 'resting MAP and MCAv mean', 'resting cerebral blood flow (CBF) and dCA', 'Hz squat-stands', 'Elevated cardiorespiratory fitness (CRF', 'Mean arterial pressure (MAP) and middle cerebral artery mean blood velocity (MCAv mean ']","[{'cui': 'C0518031', 'cui_str': 'Endurance capacity'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0036572', 'cui_str': 'Seizures'}]",[],"[{'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0024779', 'cui_str': 'Map'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0428714', 'cui_str': 'Cerebral Blood Flow'}, {'cui': 'C0600203', 'cui_str': 'DCA'}, {'cui': 'C0241236', 'cui_str': 'Does squat (finding)'}, {'cui': 'C3888057', 'cui_str': 'Stand'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0010132', 'cui_str': 'corticorelin'}, {'cui': 'C0428886', 'cui_str': 'Mean Arterial Pressure'}, {'cui': 'C0149566', 'cui_str': 'Middle Cerebral Artery'}, {'cui': 'C1531610', 'cui_str': 'Blood velocity'}]",,0.04529,Neither training nor intensity had an effect on resting MAP and MCAv mean (both P > 0.05).,"[{'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'Drapeau', 'Affiliation': 'Department of Kinesiology, Faculty of Medicine, Université Laval, Québec, Canada.'}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Labrecque', 'Affiliation': 'Department of Kinesiology, Faculty of Medicine, Université Laval, Québec, Canada.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Imhoff', 'Affiliation': 'Department of Kinesiology, Faculty of Medicine, Université Laval, Québec, Canada.'}, {'ForeName': 'Myriam', 'Initials': 'M', 'LastName': 'Paquette', 'Affiliation': 'Department of Kinesiology, Faculty of Medicine, Université Laval, Québec, Canada.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Le Blanc', 'Affiliation': 'Department of Kinesiology, Faculty of Medicine, Université Laval, Québec, Canada.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Malenfant', 'Affiliation': 'Department of Kinesiology, Faculty of Medicine, Université Laval, Québec, Canada.'}, {'ForeName': 'Patrice', 'Initials': 'P', 'LastName': 'Brassard', 'Affiliation': 'Department of Kinesiology, Faculty of Medicine, Université Laval, Québec, Canada.'}]",Physiological reports,['10.14814/phy2.14185'] 650,30848494,Naltrexone Acutely Enhances Connectivity Between the Ventromedial Prefrontal Cortex and a Left Frontoparietal Network.,"BACKGROUND Naltrexone, an opioid receptor antagonist that is Food and Drug Administration approved for treating alcohol use disorder (AUD), reduces alcohol craving and intake. Despite known pharmacological properties, little is known regarding the effects of naltrexone on neural circuit function. Thus, a data-driven examination of the neural effects of naltrexone in human subjects may offer novel insight into its treatment mechanisms. METHODS Twenty-one alcohol using males (22 to 39) participated in a double-blind, placebo-controlled crossover study of the effects of naltrexone on brain voxel-wise functional connectivity (FC) using intersubject FC correlation mapping. We first cross-correlated the time series from each gray matter voxel to produce a 6,356 × 6,356 FC matrix for each subject and session. We then subtracted the placebo FC matrix from the naltrexone FC matrix. To identify brain regions demonstrating significant reconfiguration of whole-brain FC patterns following naltrexone treatment, we statistically quantified the consistency of patterns of voxel FC changes across subjects. Permutation testing identified significant clusters of voxels undergoing significant reconfiguration. Using the identified clusters in a seed-based FC analysis, we then compared the FC patterns of affected brain areas on placebo versus naltrexone in a paired t-test. Ridge regression analyses identified self-report measures, including substance use, that significantly predicted individual differences in FC among naltrexone-modulated regions. RESULTS Two clusters in the rostral anterior cingulate cortex (rACC)/ventromedial prefrontal cortex (vmPFC) demonstrated significant modulation of FC by naltrexone. Using these 2 proximal clusters as a single seed, specific FC changes were identified in regions associated with a left frontoparietal network (increasing), as well as visual and motor regions (decreasing). Stronger FC between the rACC/vmPFC and this set of regions on placebo was associated with more external locus of control, whereas weaker connectivity was associated with greater substance use problems. Naltrexone strengthened these connections most among individuals who reported greater drinking to cope. CONCLUSIONS Enhancing connectivity between the rACC/vmPFC, implicated in alcohol craving, and components of a left frontoparietal network involved in executive control may represent an effective strategy for the treatment of AUD.",2019,"Ridge regression analyses identified self-report measures, including substance use, that significantly predicted individual differences in FC among naltrexone-modulated regions. ","['Twenty-one alcohol using males (22 to 39', 'human subjects', 'individuals who reported greater drinking to cope']","['placebo', 'naltrexone', 'placebo versus naltrexone', 'Naltrexone', 'naltrexone FC matrix']","['rostral anterior cingulate cortex (rACC)/ventromedial prefrontal cortex (vmPFC', 'brain voxel-wise functional connectivity (FC', 'voxel FC changes']","[{'cui': 'C3715213', 'cui_str': '21 (qualifier value)'}, {'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0080105', 'cui_str': 'Human Subjects'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0684271', 'cui_str': 'Drinkings'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0027360', 'cui_str': 'Naltrexone'}, {'cui': 'C4319583', 'cui_str': 'Matrix'}]","[{'cui': 'C3163631', 'cui_str': 'Rostral'}, {'cui': 'C0175190', 'cui_str': 'Anterior Cingulate'}, {'cui': 'C0162783', 'cui_str': 'Prefrontal Cortex'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]",6356.0,0.0446436,"Ridge regression analyses identified self-report measures, including substance use, that significantly predicted individual differences in FC among naltrexone-modulated regions. ","[{'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Elton', 'Affiliation': 'Department of Psychology and Neuroscience, University of North Carolina, Chapel Hill, North Carolina.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Dove', 'Affiliation': 'Department of Psychology and Neuroscience, University of North Carolina, Chapel Hill, North Carolina.'}, {'ForeName': 'Cory N', 'Initials': 'CN', 'LastName': 'Spencer', 'Affiliation': 'Department of Psychology and Neuroscience, University of North Carolina, Chapel Hill, North Carolina.'}, {'ForeName': 'Donita L', 'Initials': 'DL', 'LastName': 'Robinson', 'Affiliation': 'Bowles Center for Alcohol Studies, University of North Carolina, Chapel Hill, North Carolina.'}, {'ForeName': 'Charlotte A', 'Initials': 'CA', 'LastName': 'Boettiger', 'Affiliation': 'Department of Psychology and Neuroscience, University of North Carolina, Chapel Hill, North Carolina.'}]","Alcoholism, clinical and experimental research",['10.1111/acer.13999'] 651,30849341,Effect of Graft Attachment Status and Intraocular Pressure on Descemet Stripping Automated Endothelial Keratoplasty Outcomes in the Cornea Preservation Time Study.,"PURPOSE To examine the association of donor, recipient, and operative factors on graft dislocation after Descemet stripping automated endothelial keratoplasty (DSAEK) in the Cornea Preservation Time Study (CPTS) as well as the effects of graft dislocation and elevated IOP on graft success and endothelial cell density (ECD) 3 years postoperatively. DESIGN Cohort study within a multi-center, double-masked, randomized clinical trial. METHODS 1090 individuals (1330 study eyes), median age 70 years, undergoing DSAEK for Fuchs endothelial corneal dystrophy (94% of eyes) or pseudophakic or aphakic corneal edema (6% of eyes). Recipient eyes receiving donor corneal tissue randomized by preservation time (PT) of 0-7 days (N = 675) or 8-14 days (N = 655) were monitored for early or late graft failure through 3 years. Donor, recipient, operative, and postoperative parameters were recorded including graft dislocation (GD), partial detachment, and pre- and post-operative IOP. Pre- and postoperative central donor ECD were determined by a central image analysis reading center. Proportional hazards, mixed effects, and logistic regression models estimated risk ratios and (99% confidence intervals). RESULTS Three independent predictive factors for GD were identified: a history of donor diabetes (odds ratio [OR]: 2.29 [1.30, 4.02]), increased pre-lamellar dissection central corneal thickness (OR: 1.13 [1.01, 1.27] per 25µ increase), and operative complications (OR: 2.97 [1.24, 7.11]). Among 104 (8%) eyes with GD, 30 (28.9%) developed primary donor or early failure and 5 (4.8%) developed late failure vs. 15 (1.2%; P < .001) and 29 (2.4%; P = .04), respectively, of 1226 eyes without GD. 24 (2%) of 1330 study eyes had early acutely elevated postoperative IOP that was associated with a higher risk of graft failure through 3 years (hazard ratio: 3.42 [1.01, 11.53]), but not with a lower mean 3-year ECD (mean difference 61 (-479, 601) cells/mm 2 , P = .77). History of elevated postoperative IOP beyond 1 month was not significantly associated with 3-year graft success or ECD. CONCLUSIONS Donor diabetes, increased donor corneal thickness, and intraoperative complications were associated with an increased risk of GD. Early acutely elevated postoperative IOP and GD significantly increased the risk for graft failure following DSAEK.",2019,"Among 104 (8%) eyes with GD, 30 (28.9%) developed primary donor or early failure and 5 (4.8%) developed late failure vs. 15 (1.2%; P < .001) and 29 (2.4%; P = .04), respectively, of 1226 eyes without GD.","['1090 individuals (1330 study eyes), median age 70 years, undergoing DSAEK for Fuchs endothelial corneal dystrophy (94% of eyes) or pseudophakic or aphakic corneal edema (6% of eyes']","['Recipient eyes receiving donor corneal tissue randomized by preservation time (PT', 'Graft Attachment Status and Intraocular Pressure', 'Descemet stripping automated endothelial keratoplasty (DSAEK']","['late failure', '3-year graft success', 'Pre- and postoperative', 'risk for graft failure', 'risk of GD', 'central donor ECD', 'donor corneal thickness, and intraoperative complications', 'pre-lamellar dissection central corneal thickness (OR', 'graft dislocation (GD), partial detachment, and pre- and post-operative IOP', 'primary donor or early failure', 'mean 3-year ECD', 'operative complications', 'risk of graft failure']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0544008', 'cui_str': 'Dystrophy Endothelial Cornea'}, {'cui': 'C0339264', 'cui_str': 'Aphakic corneal edema (disorder)'}]","[{'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1527362', 'cui_str': 'grafts'}, {'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0021888', 'cui_str': 'Ocular Tension'}, {'cui': 'C0205554', 'cui_str': 'Automated (qualifier value)'}, {'cui': 'C2366835', 'cui_str': 'Endothelial keratoplasty'}]","[{'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1527362', 'cui_str': 'grafts'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C1262018', 'cui_str': 'Transplant failure'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0429493', 'cui_str': 'Corneal thickness (observable entity)'}, {'cui': 'C0021890', 'cui_str': 'Peroperative Complications'}, {'cui': 'C0012737', 'cui_str': 'Dissection'}, {'cui': 'C1720164', 'cui_str': 'Central corneal thickness'}, {'cui': 'C0012691', 'cui_str': 'Joint Dislocations'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C0541879', 'cui_str': 'Detachment'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",655.0,0.522229,"Among 104 (8%) eyes with GD, 30 (28.9%) developed primary donor or early failure and 5 (4.8%) developed late failure vs. 15 (1.2%; P < .001) and 29 (2.4%; P = .04), respectively, of 1226 eyes without GD.","[{'ForeName': 'Anthony J', 'Initials': 'AJ', 'LastName': 'Aldave', 'Affiliation': 'Stein Eye Institute, University of California, Los Angeles, Los Angeles, California, USA.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Terry', 'Affiliation': 'Devers Eye Institute, Portland, Oregon, USA.'}, {'ForeName': 'Loretta B', 'Initials': 'LB', 'LastName': 'Szczotka-Flynn', 'Affiliation': 'Case Western Reserve University Department of Ophthalmology and Visual Sciences, University Hospitals Eye Institute, and the Cornea Image Analysis Reading Center, Cleveland, Ohio, USA.'}, {'ForeName': 'Wendi', 'Initials': 'W', 'LastName': 'Liang', 'Affiliation': 'Jaeb Center for Health Research, Tampa, Florida, USA.'}, {'ForeName': 'Allison R', 'Initials': 'AR', 'LastName': 'Ayala', 'Affiliation': 'Jaeb Center for Health Research, Tampa, Florida, USA.'}, {'ForeName': 'Maureen G', 'Initials': 'MG', 'LastName': 'Maguire', 'Affiliation': 'Center for Preventive Ophthalmology and Biostatistics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Robert C', 'Initials': 'RC', 'LastName': ""O'Brien"", 'Affiliation': 'Jaeb Center for Health Research, Tampa, Florida, USA.'}, {'ForeName': 'Beth Ann', 'Initials': 'BA', 'LastName': 'Benetz', 'Affiliation': 'Case Western Reserve University Department of Ophthalmology and Visual Sciences, University Hospitals Eye Institute, and the Cornea Image Analysis Reading Center, Cleveland, Ohio, USA.'}, {'ForeName': 'John E', 'Initials': 'JE', 'LastName': 'Bokosky', 'Affiliation': 'Eye Care of San Diego, San Diego, California, USA.'}, {'ForeName': 'Steven P', 'Initials': 'SP', 'LastName': 'Dunn', 'Affiliation': 'Michigan Cornea Consultants, P.C., Southfield, Michigan, USA.'}, {'ForeName': 'Thomas E', 'Initials': 'TE', 'LastName': 'Gillette', 'Affiliation': 'Eye Associates Northwest, Seattle, Washington, USA.'}, {'ForeName': 'Kristin M', 'Initials': 'KM', 'LastName': 'Hammersmith', 'Affiliation': 'Wills Eye Hospital, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Hardten', 'Affiliation': 'Minnesota Eye Consultants, Bloomington, Minnesota, USA.'}, {'ForeName': 'Bennie H', 'Initials': 'BH', 'LastName': 'Jeng', 'Affiliation': 'University of California, San Francisco, San Francisco, California, USA.'}, {'ForeName': 'Marc F', 'Initials': 'MF', 'LastName': 'Jones', 'Affiliation': 'Northeast Ohio Eye Surgeons, Kent, Ohio, USA.'}, {'ForeName': 'Richard L', 'Initials': 'RL', 'LastName': 'Lindstrom', 'Affiliation': 'Minnesota Eye Consultants, Bloomington, Minnesota, USA.'}, {'ForeName': 'Kenneth J', 'Initials': 'KJ', 'LastName': 'Maverick', 'Affiliation': 'Focal Point Vision, San Antonio, Texas, USA.'}, {'ForeName': 'Verinder S', 'Initials': 'VS', 'LastName': 'Nirankari', 'Affiliation': 'Eye Consultants of Maryland, Owings Mills, Maryland, USA.'}, {'ForeName': 'Matthew S', 'Initials': 'MS', 'LastName': 'Oliva', 'Affiliation': 'Medical Eye Center, Medford, Oregon, USA.'}, {'ForeName': 'Irving M', 'Initials': 'IM', 'LastName': 'Raber', 'Affiliation': 'Ophthalmic Partners of PA, P.C., Bala Cynwyd, Pennsylvania, USA.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Rapuano', 'Affiliation': 'Wills Eye Hospital, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'George O D', 'Initials': 'GOD', 'LastName': 'Rosenwasser', 'Affiliation': 'Central Pennsylvania Eye Institute, Hershey, Pennsylvania, USA.'}, {'ForeName': 'Kevin W', 'Initials': 'KW', 'LastName': 'Ross', 'Affiliation': 'Eversight, Ann Arbor, Michigan, USA.'}, {'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'Seedor', 'Affiliation': 'New York Eye and Ear Infirmary, New York, New York, USA.'}, {'ForeName': 'Neda', 'Initials': 'N', 'LastName': 'Shamie', 'Affiliation': 'Keck Medical Center of University of Southern California, Ophthalmology, Los Angeles, California, USA.'}, {'ForeName': 'Christopher G', 'Initials': 'CG', 'LastName': 'Stoeger', 'Affiliation': 'Lions VisionGift, Portland, Oregon, USA.'}, {'ForeName': 'Shachar', 'Initials': 'S', 'LastName': 'Tauber', 'Affiliation': ""Mercy-St. John's Clinic, Springfield, Missouri, USA.""}, {'ForeName': 'Woodford S', 'Initials': 'WS', 'LastName': 'Van Meter', 'Affiliation': 'University of Kentucky Department of Ophthalmology, Lexington, Kentucky, USA.'}, {'ForeName': 'David D', 'Initials': 'DD', 'LastName': 'Verdier', 'Affiliation': 'Verdier Eye Center, Grand Rapids, Michigan, USA.'}, {'ForeName': 'Jonathan H', 'Initials': 'JH', 'LastName': 'Lass', 'Affiliation': 'Case Western Reserve University Department of Ophthalmology and Visual Sciences, University Hospitals Eye Institute, and the Cornea Image Analysis Reading Center, Cleveland, Ohio, USA. Electronic address: jlasscornea@gmail.com.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American journal of ophthalmology,['10.1016/j.ajo.2019.02.029'] 652,30242962,"NYX-2925, A Novel N-methyl-D-aspartate Receptor Modulator: A First-in-Human, Randomized, Double-blind Study of Safety and Pharmacokinetics in Adults.","NYX-2925, a new chemical entity, acts as a co-agonist to glutamate at the N-methyl-D-aspartate receptor (NMDAR). At low concentrations of endogenous agonists (glycine/D-serine), NYX-2925 partially activates NMDARs, modulating neural pathways relevant for chronic pain. NYX-2925 is being developed for the treatment of chronic pain conditions, including painful diabetic peripheral neuropathy and fibromyalgia. In this first-in-human, phase I, single-ascending dose (50-1,200 mg) and multiple-ascending dose (150-900 mg) study, the safety, tolerability, and pharmacokinetics (PKs) of NYX-2925 were evaluated in 84 healthy adult volunteers. No safety concerns emerged, including no dissociative side effects. NYX-2925 exhibited dose-proportional PKs and minimal accumulation following once-daily dosing for 7 days. Cerebrospinal fluid (CSF) measurements confirmed that NYX-2925 crosses the blood brain barrier, with maximum CSF concentrations approximating 6-9% of maximum plasma concentrations at the same dose level. NYX-2925 was safe and well-tolerated in healthy volunteers, and the study results support the continued clinical development for chronic pain conditions.",2019,"At low concentrations of endogenous agonists (glycine/D-serine), NYX-2925 partially activates NMDARs, modulating neural pathways relevant for chronic pain.","['Adults', 'healthy volunteers', '84 healthy adult volunteers']","['NYX-2925', 'Novel N-methyl-D-aspartate Receptor Modulator']","['safe and well-tolerated', 'safety, tolerability, and pharmacokinetics (PKs) of NYX-2925']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}]","[{'cui': 'C0080093', 'cui_str': 'N-Methyl-D-Aspartate Receptors'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}]",84.0,0.0916598,"At low concentrations of endogenous agonists (glycine/D-serine), NYX-2925 partially activates NMDARs, modulating neural pathways relevant for chronic pain.","[{'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Houck', 'Affiliation': 'Aptinyx Inc., Evanston, Illinois, USA.'}, {'ForeName': 'Laurel', 'Initials': 'L', 'LastName': 'Sindelar', 'Affiliation': 'Aptinyx Inc., Evanston, Illinois, USA.'}, {'ForeName': 'Carlos R', 'Initials': 'CR', 'LastName': 'Sanabria', 'Affiliation': 'Spaulding Clinical Research, LLC, West Bend, Wisconsin, USA.'}, {'ForeName': 'Stephanie H', 'Initials': 'SH', 'LastName': 'Stanworth', 'Affiliation': 'Spaulding Clinical Research, LLC, West Bend, Wisconsin, USA.'}, {'ForeName': 'Maggie', 'Initials': 'M', 'LastName': 'Krueger', 'Affiliation': 'Aptinyx Inc., Evanston, Illinois, USA.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Suh', 'Affiliation': 'Aptinyx Inc., Evanston, Illinois, USA.'}, {'ForeName': 'Torsten M', 'Initials': 'TM', 'LastName': 'Madsen', 'Affiliation': 'Aptinyx Inc., Evanston, Illinois, USA.'}]",Clinical and translational science,['10.1111/cts.12584'] 653,31367877,Fecal Microbiota Transplant via Endoscopic Delivering Through Small Intestine and Colon: No Difference for Crohn's Disease.,"BACKGROUND AND AIMS Crohn's disease (CD) is a chronic inflammatory bowel disorder associated with intestinal dysbiosis. This study aimed to determine the efficacy and safety of different methods of fecal microbiota transplantation (FMT), a potential therapy for CD. METHODS Patients with CD were randomized to receive FMT by gastroscopy or colonoscopy; a second transplantation was performed 1 week later. Patients were assessed by clinical evaluation and serum testing (at weeks 1, 2, 4, 6, and 8) and endoscopy (8 weeks after transplantation). Fecal DNA was extracted and analyzed using the Illuminal sequencing platform. RESULTS Of the 27 patients included in the study, clinical remission was achieved in 18 (66.7%); no significant difference was seen between the two methods. 76.9% of gastroscopy group patients and 64.3% of colonoscopy group patients experienced mild adverse events during or shortly after treatment. Microbiota diversity analyses showed that, in comparison with the donors, patients had lower operational taxonomic units (OTU; 117 vs. 258, p < 0.05) and Shannon diversity index (2.05 vs. 3.46, p < 0.05). The CD patients showed a significant increase in OTU and Shannon diversity index 2 weeks after FMT. In comparison with the donors, CD patients had lower levels of Bacteroides, Eubacterium, faecalibacterium, and Roseburia, and higher levels of Clostridium, Cronobacter, Fusobacterium, and Streptococcus. CONCLUSIONS FMT was seen to be safe and effective in this cohort of patients with CD. No significant differences in clinical remission rate and adverse events were seen between the gastroscopy and colonoscopy groups. FMT was seen to increase the species richness in CD patients.",2020,"In comparison with the donors, CD patients had lower levels of Bacteroides, Eubacterium, faecalibacterium, and Roseburia, and higher levels of Clostridium, Cronobacter, Fusobacterium, and Streptococcus. ","['Patients with CD', 'Fecal Microbiota Transplant via Endoscopic Delivering Through Small Intestine and Colon', '27 patients included in the study']","['FMT by gastroscopy or colonoscopy', 'FMT', 'fecal microbiota transplantation (FMT']","['clinical remission', 'species richness', 'mild adverse events', 'Fecal DNA', 'efficacy and safety', 'Shannon diversity index', 'OTU and Shannon diversity index', 'safe and effective', 'lower levels of Bacteroides, Eubacterium, faecalibacterium, and Roseburia, and higher levels of Clostridium, Cronobacter, Fusobacterium, and Streptococcus', 'clinical remission rate and adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C0332835', 'cui_str': 'Grafts'}, {'cui': 'C0021852', 'cui_str': 'Intestines, Small'}, {'cui': 'C0009368', 'cui_str': 'Colon'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0017195', 'cui_str': 'Gastroscopy'}, {'cui': 'C0009378', 'cui_str': 'Endoscopy of colon'}, {'cui': 'C2242628', 'cui_str': 'Fecal Transplantation'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0012854', 'cui_str': 'Deoxyribonucleic Acid'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0004661', 'cui_str': 'Bacteroides'}, {'cui': 'C0015146', 'cui_str': 'Eubacterium'}, {'cui': 'C1229075', 'cui_str': 'Faecalibacterium'}, {'cui': 'C0995401', 'cui_str': 'Roseburia'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0009054', 'cui_str': 'Clostridium'}, {'cui': 'C1894384', 'cui_str': 'Cronobacter'}, {'cui': 'C0016878', 'cui_str': 'Sphaerophorus'}, {'cui': 'C0038402', 'cui_str': 'Streptococcus'}]",,0.0487709,"In comparison with the donors, CD patients had lower levels of Bacteroides, Eubacterium, faecalibacterium, and Roseburia, and higher levels of Clostridium, Cronobacter, Fusobacterium, and Streptococcus. ","[{'ForeName': 'Zhenyu', 'Initials': 'Z', 'LastName': 'Yang', 'Affiliation': 'Department of Gastroenterology, Third Xiangya Hospital, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Chibin', 'Initials': 'C', 'LastName': 'Bu', 'Affiliation': 'Department of Gastroenterology, Third Xiangya Hospital, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Yuan', 'Affiliation': 'Department of Gastroenterology, Third Xiangya Hospital, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Zhaohua', 'Initials': 'Z', 'LastName': 'Shen', 'Affiliation': 'Department of Gastroenterology, Third Xiangya Hospital, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Yongsheng', 'Initials': 'Y', 'LastName': 'Quan', 'Affiliation': 'Department of Gastroenterology, Third Xiangya Hospital, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Shuai', 'Initials': 'S', 'LastName': 'Wu', 'Affiliation': 'Department of Gastroenterology, Third Xiangya Hospital, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Changxin', 'Initials': 'C', 'LastName': 'Zhu', 'Affiliation': 'Department of Gastroenterology, Third Xiangya Hospital, Central South University, Changsha, Hunan, China.'}, {'ForeName': 'Xiaoyan', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Gastroenterology, Third Xiangya Hospital, Central South University, Changsha, Hunan, China. wxy20011@163.com.'}]",Digestive diseases and sciences,['10.1007/s10620-019-05751-y'] 654,31367878,Chyme Reinfusion Is Associated with Lower Rate of Postoperative Ileus in Crohn's Disease Patients After Stoma Closure.,"BACKGROUND The rate of postoperative ileus following stoma closure is high in patients with Crohn's disease and temporary enterostomy. AIMS To evaluate the effect of chyme reinfusion on postoperative outcomes including ileus in these patients. METHODS Patients were screened from January 2012 to December 2017 and divided into chyme reinfusion group (n = 33) and non-chyme reinfusion group (n = 84). The following 30-day postoperative outcomes were evaluated. Univariate and multivariate analyses and propensity score matching were performed to identify risk factors for these postoperative outcomes. RESULTS The incidence of postoperative ileus was significantly lower in the chyme reinfusion than in non-chyme reinfusion group, which had been confirmed by the results after matching (3/26 vs 11/26, p = 0.012). The rate of postoperative diarrhea was significantly lower in the chyme reinfusion group compared with non-chyme reinfusion group, whereas the difference was not significant after matching (2/26 vs 6/26, p = 0.191). Additionally, the postoperative length of stay was significantly shorter in the chyme reinfusion than in non-chyme reinfusion group before and after propensity score matching. In the multivariate analysis, chyme reinfusion was an independent protective factor for postoperative ileus (odds ratio 0.218; 95% confidence interval 0.05-0.95; p = 0.042) and for postoperative length of stay (coefficient - 0.191; 95% confidence interval - 0.350 to - 0.032, p = 0.019). CONCLUSIONS Chyme reinfusion was associated with lower rate of postoperative ileus and shorter length of stay following stoma closure in Crohn's patients with temporary ileostomy. Further randomized clinical trial between patients with or without chyme reinfusion was needed to confirm these conclusions.",2020,"The incidence of postoperative ileus was significantly lower in the chyme reinfusion than in non-chyme reinfusion group, which had been confirmed by the results after matching (3/26 vs 11/26, p = 0.012).","[""Crohn's Disease Patients After Stoma Closure"", ""Crohn's patients with temporary ileostomy"", ""patients with Crohn's disease and temporary enterostomy"", 'ileus in these patients', 'patients with or without chyme reinfusion', 'Patients were screened from January 2012 to December 2017 and divided into chyme reinfusion group (n\u2009=\u200933) and non-chyme reinfusion group (n\u2009=\u200984']","['Chyme Reinfusion', 'chyme reinfusion']","['incidence of postoperative ileus', 'postoperative length of stay', 'protective factor for postoperative ileus', 'rate of postoperative diarrhea']","[{'cui': 'C0156147', 'cui_str': 'Colitis, Granulomatous'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3665863', 'cui_str': 'Stoma closure'}, {'cui': 'C0010346', 'cui_str': 'Regional Enteritis'}, {'cui': 'C2937270', 'cui_str': 'Creation of temporary ileostomy (procedure)'}, {'cui': 'C0205374', 'cui_str': 'Transitory (qualifier value)'}, {'cui': 'C1442523', 'cui_str': 'Enterostomy (morphologic abnormality)'}, {'cui': 'C1258215', 'cui_str': 'Ileus'}, {'cui': 'C0227258', 'cui_str': 'Small intestine contents (substance)'}, {'cui': 'C0854643', 'cui_str': 'Reinfusion'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0227258', 'cui_str': 'Small intestine contents (substance)'}, {'cui': 'C0854643', 'cui_str': 'Reinfusion'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0400877', 'cui_str': 'Postoperative ileus (disorder)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0679688', 'cui_str': 'Protective Factors'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}]",,0.072543,"The incidence of postoperative ileus was significantly lower in the chyme reinfusion than in non-chyme reinfusion group, which had been confirmed by the results after matching (3/26 vs 11/26, p = 0.012).","[{'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Duan', 'Affiliation': 'Jinling Hospital Research Institute General Surgery, Nanjing University, School of Medicine, No. 305 East Zhongshan Road, Nanjing, 210002, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Cao', 'Affiliation': 'Jinling Hospital Research Institute General Surgery, Nanjing University, School of Medicine, No. 305 East Zhongshan Road, Nanjing, 210002, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Gao', 'Affiliation': 'Jinling Hospital Research Institute General Surgery, Nanjing University, School of Medicine, No. 305 East Zhongshan Road, Nanjing, 210002, China.'}, {'ForeName': 'Jianfeng', 'Initials': 'J', 'LastName': 'Gong', 'Affiliation': 'Jinling Hospital Research Institute General Surgery, Nanjing University, School of Medicine, No. 305 East Zhongshan Road, Nanjing, 210002, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Jinling Hospital Research Institute General Surgery, Nanjing University, School of Medicine, No. 305 East Zhongshan Road, Nanjing, 210002, China. liyi.jlh@hotmail.com.'}, {'ForeName': 'Weiming', 'Initials': 'W', 'LastName': 'Zhu', 'Affiliation': 'Jinling Hospital Research Institute General Surgery, Nanjing University, School of Medicine, No. 305 East Zhongshan Road, Nanjing, 210002, China. juwiming@nju.edu.cn.'}]",Digestive diseases and sciences,['10.1007/s10620-019-05753-w'] 655,31013466,Effectiveness of Telephone-Administered Cognitive-Behavioral Psychotherapy for Depression With Versus Without Additional Letters: A Randomized Controlled Trial.,"Background: Telephone-administered cognitive-behavioral psychotherapy (T-CBT) can effectively treat patients with depressive symptoms. Introduction: We investigated whether adding letters (via postal mail) to T-CBT reduces depressive symptoms and increases response and remission. Additionally, we assessed whether T-CBT reduced all patients' symptoms in the first depression-specific T-CBT sample in German healthcare. Materials and Methods: Primary care patients were randomized to T-CBT with versus without letters. All received 1 face-to-face and 8-12 telephone-administered sessions. An intention-to-treat sample was analyzed. Between-groups differences in symptom change and the total sample's symptom change were computed using linear mixed models with group as fixed effect, referring general practice as random effect and several covariates. Differences in response and remission were assessed using logistic regressions. Results: Fifty-nine patients were referred to T-CBT and randomized. Twenty-six patients actually participated in T-CBT with letters and 21 without letters. The groups did not differ significantly regarding symptom change (Patient Health Questionnaire [PHQ-9]) from baseline to end: T-CBT without letters showed 1.05 points greater reduction (95% confidence interval: -4.72 to 2.62; p = 0.56; Cohen's d = -0.12) (adjusted mean change). The groups did not differ significantly regarding symptom change from baseline to 6-month follow-up nor odds of response or remission. The total sample's PHQ-9 showed significant adjusted mean reduction from baseline to end of T-CBT and to 6-month follow-up. Discussion: Additional letters did not lead to greater symptom reduction. Overall results for the first German T-CBT intervention for depression appear promising but require further assessment using a control condition. Conclusions: Additional letters do not appear to enhance the effectiveness of T-CBT.",2020,The groups did not differ significantly regarding symptom change from baseline to 6-month follow-up nor odds of response or remission.,"['Twenty-six patients actually participated in T-CBT with letters and 21 without letters', 'Primary care patients', 'Fifty-nine patients were referred to T-CBT and randomized', 'patients with depressive symptoms']","['Telephone-Administered Cognitive-Behavioral Psychotherapy', 'Telephone-administered cognitive-behavioral psychotherapy (T-CBT', 'T-CBT with versus without letters']","['response and remission', 'depressive symptoms and increases response and remission', 'symptom change', ""symptom change and the total sample's symptom change"", 'symptom change (Patient Health Questionnaire [PHQ-9']","[{'cui': 'C0450349', 'cui_str': '26 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1096774', 'cui_str': 'Letter'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C3830128', 'cui_str': '59 (qualifier value)'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}]","[{'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0004933', 'cui_str': 'Behavior Modification'}, {'cui': 'C1096774', 'cui_str': 'Letter'}]","[{'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C1879301', 'cui_str': 'Patient Health Questionnaire'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}]",59.0,0.142745,The groups did not differ significantly regarding symptom change from baseline to 6-month follow-up nor odds of response or remission.,"[{'ForeName': 'Maya', 'Initials': 'M', 'LastName': 'Steinmann', 'Affiliation': 'Department of Medical Psychology and University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Heddaeus', 'Affiliation': 'Department of Medical Psychology and University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Liebherz', 'Affiliation': 'Department of Medical Psychology and University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Daubmann', 'Affiliation': 'Department of Medical Biometry and Epidemiology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Härter', 'Affiliation': 'Department of Medical Psychology and University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Birgit', 'Initials': 'B', 'LastName': 'Watzke', 'Affiliation': 'Clinical Psychology and Psychotherapy Research, Institute of Psychology, University of Zurich, Zurich, Switzerland.'}]",Telemedicine journal and e-health : the official journal of the American Telemedicine Association,['10.1089/tmj.2018.0311'] 656,31901759,Is digital cognitive behavioural therapy for insomnia effective in treating sub-threshold insomnia: a pilot RCT.,"OBJECTIVE/BACKGROUND Many patients find cognitive behavioral therapy for insomnia (CBT-I) useful. However, it is currently unknown if those with sub-threshold insomnia also benefit. Here we assessed whether CBT-I is both feasible and acceptable in participants with sub-threshold insomnia. The primary aims were to evaluate participation rates and treatment acceptability, and to establish an effect size for symptom improvement. PATIENTS/METHODS A total of 199 female participants (M age 20 ± 5 years) took part. Following baseline assessments, participants were randomly allocated to either a six-week digital CBT-I intervention or a six-week control group receiving puzzles. Additional assessments were performed three-weeks, six-weeks, and six-months later. RESULTS Participation rates at each survey assessment wave did not differ between the groups (ps > 0.140), though adherence to completing each weekly task was lower in the CBT-I group, p = 0.02. Treatment acceptability was high (M (SD) = 33.61 (4.82), theoretical range 6-42). The CBT-I group showed greater improvement in insomnia symptoms at the end of the intervention compared to the control group (p = 0.013, d = 0.42), with significant variation in outcome (M = 4.69, SD = 5.41). Sub-threshold participants showed a similar pattern of results, whilst those meeting insomnia criteria showed a smaller between-group difference. CBT-I led to improvements in anxiety, paranoia and perceived stress between baseline and end of intervention. Changes in insomnia symptoms were mediated by cognitions about sleep and somatic pre-sleep arousal. CONCLUSIONS CBT-I provides a benefit even in sub-threshold insomnia. CBT-I may be useful to tackle insomnia symptoms even when they are sub-threshold.",2020,"The CBT-I group showed greater improvement in insomnia symptoms at the end of the intervention compared to the control group (p = 0.013, d = 0.42), with significant variation in outcome (M = 4.69, SD = 5.41).","['199 female participants (M age 20\xa0±\xa05 years) took part', 'participants with sub-threshold insomnia']","['digital cognitive behavioural therapy', 'six-week digital CBT-I intervention or a six-week control group receiving puzzles', 'cognitive behavioral therapy']","['participation rates and treatment acceptability', 'Treatment acceptability', 'anxiety, paranoia and perceived stress', 'insomnia symptoms']","[{'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C1264637', 'cui_str': 'Substance amount'}, {'cui': 'C0449864', 'cui_str': 'Threshold (property) (qualifier value)'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}]","[{'cui': 'C0442015', 'cui_str': 'Digital X-ray (qualifier value)'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0423995', 'cui_str': 'Puzzled (finding)'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C1456784', 'cui_str': 'Paranoia'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",199.0,0.0969883,"The CBT-I group showed greater improvement in insomnia symptoms at the end of the intervention compared to the control group (p = 0.013, d = 0.42), with significant variation in outcome (M = 4.69, SD = 5.41).","[{'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Denis', 'Affiliation': 'Department of Psychiatry, Beth Israel Deaconess Medical Center, Boston, MA, USA; Department of Psychiatry, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Thalia C', 'Initials': 'TC', 'LastName': 'Eley', 'Affiliation': ""King's College London, MRC Social, Genetic, and Developmental Psychiatry Centre, Institute of Psychiatry, Psychology, and Neuroscience, London, UK.""}, {'ForeName': 'Fruhling', 'Initials': 'F', 'LastName': 'Rijsdijk', 'Affiliation': ""King's College London, MRC Social, Genetic, and Developmental Psychiatry Centre, Institute of Psychiatry, Psychology, and Neuroscience, London, UK.""}, {'ForeName': 'Helena M S', 'Initials': 'HMS', 'LastName': 'Zavos', 'Affiliation': ""Department of Psychology, King's College London, London, UK.""}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Keers', 'Affiliation': 'School of Biological and Chemical Sciences, Queen Mary, University of London, London, UK.'}, {'ForeName': 'Colin A', 'Initials': 'CA', 'LastName': 'Espie', 'Affiliation': 'Sleep and Circadian Neuroscience Institute, Nuffield Department of Clinical Neurosciences, University of Oxford, Oxford, UK; Big Health Ltd, London, UK.'}, {'ForeName': 'Annemarie I', 'Initials': 'AI', 'LastName': 'Luik', 'Affiliation': 'Sleep and Circadian Neuroscience Institute, Nuffield Department of Clinical Neurosciences, University of Oxford, Oxford, UK; Department of Epidemiology, Erasmus MC University Medical Center, Rotterdam, the Netherlands.'}, {'ForeName': 'Isabella', 'Initials': 'I', 'LastName': 'Badini', 'Affiliation': 'Department of Psychology, Goldsmiths, University of London, London, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Derveeuw', 'Affiliation': ""King's College London, MRC Social, Genetic, and Developmental Psychiatry Centre, Institute of Psychiatry, Psychology, and Neuroscience, London, UK.""}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Hodsoll', 'Affiliation': ""King's College London, Department of Biostatistics, Institute of Psychiatry, Psychology, and Neuroscience, London, UK.""}, {'ForeName': 'Alice M', 'Initials': 'AM', 'LastName': 'Gregory', 'Affiliation': 'Department of Psychology, Goldsmiths, University of London, London, UK. Electronic address: a.gregory@gold.ac.uk.'}]",Sleep medicine,['10.1016/j.sleep.2019.10.007'] 657,31689640,Protective behavioral strategies predict alcohol-related problems among injured patients following a brief intervention.,"BACKGROUND Alcohol protective behavioral strategies (PBS) have been proposed as mechanisms of change underlying interventions for reducing alcohol use and alcohol-related problems. Few studies have examined PBS use among non-college student populations and no study has examined PBS use among adult injured patients. The current study tested types of PBS as mediators of the effects of a brief motivational intervention (BMI) delivered in the trauma care setting on alcohol-related problems. METHOD Secondary data analyses were conducted using data from a multisite randomized controlled trial of brief intervention in the trauma care setting. The current study used data from a subset of participants who reported having consumed alcohol at least once at 3-month follow-up (N = 324). Following a baseline assessment, participants were assigned to either brief advice (BA; n = 107), BMI (n = 119), or BMI with a telephone booster (BMI + B; n = 98). Participants completed measures of PBS at 3-month follow-up and of alcohol-related problems at baseline and 6-month follow-up. A multiple mediation model was conducted to simultaneously test the mediation effects of types of PBS. RESULTS BMI and BMI + B relative to BA did not increase PBS use. However, more frequent use of certain types of PBS at 3-month follow-up were predictors of greater reductions in alcohol-related problems from baseline to 6-month follow-up. There were no statistically significant mediation effects. CONCLUSIONS The present study suggests that PBS use reduces alcohol-related problems among trauma patients and implications for future studies are discussed.",2019,"There were no statistically significant mediation effects. ","['injured patients following a brief intervention', 'adult injured patients', 'participants who reported having consumed alcohol at least once at 3-month follow-up (N\u202f=\u202f324']","['PBS', 'motivational intervention (BMI', 'Alcohol protective behavioral strategies (PBS']",['PBS'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C4517713', 'cui_str': '324'}]","[{'cui': 'C0001975', 'cui_str': 'Alcohols'}]",[],324.0,0.0369062,"There were no statistically significant mediation effects. ","[{'ForeName': 'Dylan K', 'Initials': 'DK', 'LastName': 'Richards', 'Affiliation': 'Latino Alcohol and Health Disparities Research and Training Center, University of Texas at El Paso, 500 West University Avenue, El Paso, TX 79968, USA; Department of Psychology, University of Texas at El Paso, 500 West University Avenue, El Paso, TX 79968, USA. Electronic address: dkrichards2@utep.edu.'}, {'ForeName': 'Matthew R', 'Initials': 'MR', 'LastName': 'Pearson', 'Affiliation': 'Center on Alcoholism, Substance Abuse, and Addictions, University of New Mexico, 2650 Yale Boulevard Southeast MSC11-6280, Albuquerque, NM 87106, USA.'}, {'ForeName': 'Osvaldo F', 'Initials': 'OF', 'LastName': 'Morera', 'Affiliation': 'Department of Psychology, University of Texas at El Paso, 500 West University Avenue, El Paso, TX 79968, USA.'}, {'ForeName': 'Craig A', 'Initials': 'CA', 'LastName': 'Field', 'Affiliation': 'Latino Alcohol and Health Disparities Research and Training Center, University of Texas at El Paso, 500 West University Avenue, El Paso, TX 79968, USA; Department of Psychology, University of Texas at El Paso, 500 West University Avenue, El Paso, TX 79968, USA.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2019.06.037'] 658,32153301,Efficacy and analgesic use during the therapy of iatrogenic pneumothorax using Pleuralvent™ and Chest Tube (ASPIRATE): A randomised controlled trial protocol.,"BACKGROUND Iatrogenic pneumothorax is a common complication of various diagnostic and therapeutic procedures such as transbronchial lung biopsies. The classical mode of treatment is chest tube insertion. Pneumothorax devices are now available on the market but there is a dearth of data on their efficacy to treat iatrogenic pneumothorax. It is important to provide such data as the pathophysiology of iatrogenic pneumothorax is different in comparison with spontaneous pneumothorax for which some data is available. METHODS This is a randomized, non-blinded, actively controlled trial of effectivity of iatrogenic pneumothorax treatment using the Pleuralvent™ device and chest tube insertion (16F). The secondary aim is to compare the overall pain level and the need for analgesic treatment in both treatment arms. We are planning to enrol 126 patients (63 in each treatment arm). DISCUSSION Preliminary results showed similar effectivity of the Pleuralvent™ system compared to large bore chest tube insertion. This randomized clinical trial should confirm these results and prove that the Pleuralvent™ system is an effective way of treatment of patients with iatrogenic pneumothorax. If Pleuralvent™ proves to have the same level of efficacy, it may become the standard of care of patients with iatrogenic pneumothorax. TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT03700554.",2020,This randomized clinical trial should confirm these results and prove that the Pleuralvent™ system is an effective way of treatment of patients with iatrogenic pneumothorax.,"['patients with iatrogenic pneumothorax', '126 patients (63 in each treatment arm']","['iatrogenic pneumothorax treatment', 'iatrogenic pneumothorax using Pleuralvent™ and Chest Tube (ASPIRATE']",['overall pain level'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0375336', 'cui_str': 'Iatrogenic pneumothorax'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}]","[{'cui': 'C0375336', 'cui_str': 'Iatrogenic pneumothorax'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0008034', 'cui_str': 'Chest Tubes'}, {'cui': 'C0370199', 'cui_str': 'Aspirate'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}]",,0.0818031,This randomized clinical trial should confirm these results and prove that the Pleuralvent™ system is an effective way of treatment of patients with iatrogenic pneumothorax.,"[{'ForeName': 'Milan', 'Initials': 'M', 'LastName': 'Sova', 'Affiliation': 'Department of Respiratory Medicine, Faculty of Medicine and Dentistry, Palacky University Olomouc and University Hospital Olomouc, Czech Republic.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Poruba', 'Affiliation': 'Department of Pharmacology, Faculty of Medicine and Dentistry, Palacky University Olomouc, Czech Republic.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Genzor', 'Affiliation': 'Department of Respiratory Medicine, Faculty of Medicine and Dentistry, Palacky University Olomouc and University Hospital Olomouc, Czech Republic.'}, {'ForeName': 'Petr', 'Initials': 'P', 'LastName': 'Jakubec', 'Affiliation': 'Department of Respiratory Medicine, Faculty of Medicine and Dentistry, Palacky University Olomouc and University Hospital Olomouc, Czech Republic.'}, {'ForeName': 'Jaromir', 'Initials': 'J', 'LastName': 'Zatloukal', 'Affiliation': 'Department of Respiratory Medicine, Faculty of Medicine and Dentistry, Palacky University Olomouc and University Hospital Olomouc, Czech Republic.'}, {'ForeName': 'Vitezslav', 'Initials': 'V', 'LastName': 'Kolek', 'Affiliation': 'Department of Respiratory Medicine, Faculty of Medicine and Dentistry, Palacky University Olomouc and University Hospital Olomouc, Czech Republic.'}, {'ForeName': 'Karel', 'Initials': 'K', 'LastName': 'Urbanek', 'Affiliation': 'Department of Pharmacology, Faculty of Medicine and Dentistry, Palacky University Olomouc, Czech Republic.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Vasakova', 'Affiliation': 'Department of Respiratory Medicine, 1st Faculty of Medicine Charles University in Prague, Thomayer Hospital Prague, Czech Republic.'}, {'ForeName': 'Ludek', 'Initials': 'L', 'LastName': 'Stehlik', 'Affiliation': 'Department of Respiratory Medicine, 1st Faculty of Medicine Charles University in Prague, Thomayer Hospital Prague, Czech Republic.'}, {'ForeName': 'Pavla', 'Initials': 'P', 'LastName': 'Zackova', 'Affiliation': 'Department of Respiratory Medicine, 1st Faculty of Medicine Charles University in Prague, Thomayer Hospital Prague, Czech Republic.'}, {'ForeName': 'Amjad Ghazal', 'Initials': 'AG', 'LastName': 'Asswad', 'Affiliation': 'Emergency Department, West Middlesex University Hospital, London, United Kingdom of Great Britain and Northern Ireland.'}]","Biomedical papers of the Medical Faculty of the University Palacky, Olomouc, Czechoslovakia",['10.5507/bp.2020.008'] 659,32052516,"Efficacy and safety of dual add-on therapy with dapagliflozin plus saxagliptin versus glimepiride in patients with poorly controlled type 2 diabetes on a stable dose of metformin: Results from a 52-week, randomized, active-controlled trial.","AIMS To evaluate the efficacy and safety of dapagliflozin (DAPA) + saxagliptin (SAXA) compared with glimepiride (GLIM) in patients with type 2 diabetes who were inadequately controlled [glycated haemoglobin (HbA1c) 7.5-10.5% (58-91 mmol/mol)] on metformin monotherapy. MATERIALS AND METHODS This 52-week, multicentre, double-blind, active-controlled study (NCT02419612) randomized (1:1) patients on metformin to add-on DAPA 10 mg + SAXA 5 mg (n = 227) or GLIM 1-6 mg (titrated; n = 217). The primary efficacy endpoint was change in HbA1c from baseline to week 52. RESULTS Baseline mean ± standard deviation of age, duration of diabetes and HbA1c were 56.1 ± 9.7 years, 7.8 ± 6.4 years and 8.5% ± 0.8% (69 ± 9.0 mmol/mol), respectively. Adjusted mean change from baseline in HbA1c was -1.35% (-14.8 mmol/mol) with DAPA + SAXA versus -0.98% (-10.7 mmol/mol) with GLIM (P <0.001). Changes from baseline in body weight and systolic blood pressure were -3.1 kg and -2.6 mmHg with DAPA + SAXA versus +1.0 kg (P <0.001) and +1.0 mmHg (P = 0.007) with GLIM. More patients achieved HbA1c <7.0% (53 mmol/mol) (44.3% vs. 34.3%; P = 0.044), and fewer patients required treatment intensification (1.3% vs. 8.8%; P = 0.002) with DAPA + SAXA than with GLIM. CONCLUSIONS Compared with GLIM, concurrent addition of DAPA + SAXA significantly improved glycaemic control, body weight and other metabolic parameters in patients inadequately controlled on metformin. Trial: NCT02419612, ClinicalTrials.gov.",2020,Adjusted mean change from baseline in HbA 1c was -1.35% (-14.8 mmol/mol) with DAPA + SAXA versus -0.98% (-10.7 mmol/mol) with GLIM (P < 0.001).,"['patients inadequately controlled on', 'patients with poorly controlled type 2 diabetes on a stable dose of', 'patients with type 2 diabetes inadequately controlled (glycated haemoglobin ', 'were 56.1 (9.7) years, 7.8 (6.4) years and 8.5% (0.8']","['metformin', 'glimepiride (GLIM', 'dapagliflozin (DAPA) plus saxagliptin (SAXA', 'dapagliflozin plus saxagliptin', 'metformin to add-on DAPA 10 mg plus SAXA', 'glimepiride', 'DAPA + SAXA']","['change in HbA 1c', 'efficacy and safety', 'body weight and systolic blood pressure', 'Baseline mean (standard deviation [SD]) age, duration of diabetes and HbA 1c', 'glycaemic control, body weight and other metabolic parameters', 'Efficacy and safety']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C3853134', 'cui_str': 'Poorly controlled'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0017853', 'cui_str': 'Hemoglobin, Glycosylated'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517822', 'cui_str': '6.4 (qualifier value)'}, {'cui': 'C4517877', 'cui_str': '8.5'}, {'cui': 'C4517481', 'cui_str': '0.8'}]","[{'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0061323', 'cui_str': 'glimepiride'}, {'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1611934', 'cui_str': 'saxagliptin'}, {'cui': 'C1720086', 'cui_str': 'Add - dosing instruction fragment'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",,0.188329,Adjusted mean change from baseline in HbA 1c was -1.35% (-14.8 mmol/mol) with DAPA + SAXA versus -0.98% (-10.7 mmol/mol) with GLIM (P < 0.001).,"[{'ForeName': 'Juan P', 'Initials': 'JP', 'LastName': 'Frias', 'Affiliation': 'National Research Institute, Los Angeles, California.'}, {'ForeName': 'Guillermo', 'Initials': 'G', 'LastName': 'Gonzalez-Galvez', 'Affiliation': 'Jalisco Institute of Diabetes and Obesity Research, Guadalajara, Mexico.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Johnsson', 'Affiliation': 'BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Maaske', 'Affiliation': 'BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, Maryland.'}, {'ForeName': 'Marcia A', 'Initials': 'MA', 'LastName': 'Testa', 'Affiliation': 'Harvard T.H. Chan School of Public Health, Boston, Massachusetts.'}, {'ForeName': 'Donald C', 'Initials': 'DC', 'LastName': 'Simonson', 'Affiliation': ""Division of Endocrinology, Diabetes and Hypertension, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Nalina', 'Initials': 'N', 'LastName': 'Dronamraju', 'Affiliation': 'BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Garcia-Sanchez', 'Affiliation': 'BioPharmaceuticals R&D, AstraZeneca, Gaithersburg, Maryland.'}, {'ForeName': 'Anne L', 'Initials': 'AL', 'LastName': 'Peters', 'Affiliation': 'Keck School of Medicine of the University of Southern California, Los Angeles, California.'}]","Diabetes, obesity & metabolism",['10.1111/dom.13997'] 660,31201187,"Perceptions of older adults in Ontario, Canada on the implementation and impact of a primary care programme, Health Teams Advancing Patient Experience: Strengthening Quality (Health TAPESTRY): a descriptive qualitative study.","OBJECTIVES The aim of the study was to explore the perceptions of older adults on the implementation and impact of Health Teams Advancing Patient Experience: Strengthening Quality (Health TAPESTRY), a multicomponent primary care programme that seeks to improve care coordination for individuals through health-related goal-setting supported by trained lay volunteers who are an extension of an interprofessional team, and the use of technology to support communication among the team. DESIGN This study used a qualitative descriptive design. SETTING The setting for this study was two primary care practice sites located in a large urban area in Ontario, Canada. PARTICIPANTS The sample consisted of community-dwelling older adults aged 70 years and older. Participants were recruited from a convenience sample obtained from 360 clients who participated in the 12-month Health TAPESTRY randomised controlled trial. METHODS Semistructured interviews were conducted with 32 older adults either face-to-face or by telephone. Interviews were transcribed verbatim. Data were analysed using a constant comparative approach to develop themes. RESULTS Older adults' perceptions about the Health TAPESTRY programme included (1) the lack of a clear purpose and understanding of how information was shared among providers, (2) mixed positive and negative perceptions of goal-setting and provider follow-up after inhome visits by volunteers, (3) positive impacts such as satisfaction with the primary care team, and (4) the potential for the programme to become a regular programme and applied to other communities and groups. CONCLUSIONS Older adults living in the community may benefit from greater primary care support provided through enhanced team-based approaches. Programmes such as Health TAPESTRY facilitate opportunities for older adults to work with primary care providers to meet their self-identified needs. By exploring perceptions of clients, primary care programmes can be further refined and expanded for various populations.",2019,"RESULTS Older adults' perceptions about the Health TAPESTRY programme included (1) the lack of a clear purpose and understanding of how information was shared among providers, (2) mixed positive and negative perceptions of goal-setting and provider follow-up after inhome visits by volunteers, (3) positive impacts such as satisfaction with the primary care team, and (4) the potential for the programme to become a regular programme and applied to other communities and groups. ","['Health Teams Advancing Patient Experience', 'two primary care practice sites located in a large urban area in Ontario, Canada', 'Participants were recruited from a convenience sample obtained from 360 clients who participated in the 12-month Health TAPESTRY randomised controlled trial', '32 older adults either face-to-face or by telephone', 'Older adults living', 'older adults', 'individuals through health-related goal-setting supported by trained lay volunteers who are an extension of an interprofessional team', 'The sample consisted of community-dwelling older adults aged 70 years and older', ""Older adults' perceptions""]",[],[],"[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0332285', 'cui_str': 'In (attribute)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C1277697', 'cui_str': 'Sample obtained'}, {'cui': 'C4319607', 'cui_str': '360 (qualifier value)'}, {'cui': 'C0008942', 'cui_str': 'Clients'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0150598', 'cui_str': 'Goal setting (qualifier value)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0439792', 'cui_str': 'Extents (qualifier value)'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0030971', 'cui_str': 'Perception'}]",[],[],360.0,0.0351864,"RESULTS Older adults' perceptions about the Health TAPESTRY programme included (1) the lack of a clear purpose and understanding of how information was shared among providers, (2) mixed positive and negative perceptions of goal-setting and provider follow-up after inhome visits by volunteers, (3) positive impacts such as satisfaction with the primary care team, and (4) the potential for the programme to become a regular programme and applied to other communities and groups. ","[{'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Ploeg', 'Affiliation': 'School of Nursing, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Ruta Kristina', 'Initials': 'RK', 'LastName': 'Valaitis', 'Affiliation': 'School of Nursing, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Cleghorn', 'Affiliation': 'Department of Family Medicine, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Marie-Lee', 'Initials': 'ML', 'LastName': 'Yous', 'Affiliation': 'School of Nursing, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Gaber', 'Affiliation': 'Department of Family Medicine, McMaster University Faculty of Health Sciences, Hamilton, Ontario, Canada.'}, {'ForeName': 'Gina', 'Initials': 'G', 'LastName': 'Agarwal', 'Affiliation': 'Department of Family Medicine, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Kastner', 'Affiliation': 'Research and Innovation, North York General Hospital, Toronto, Ontario, Canada.'}, {'ForeName': 'Dee', 'Initials': 'D', 'LastName': 'Mangin', 'Affiliation': 'Department of Family Medicine, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Doug', 'Initials': 'D', 'LastName': 'Oliver', 'Affiliation': 'Department of Family Medicine, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Parascandalo', 'Affiliation': 'Department of Family Medicine, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Cathy', 'Initials': 'C', 'LastName': 'Risdon', 'Affiliation': 'Department of Family Medicine, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Dolovich', 'Affiliation': 'Department of Family Medicine, McMaster University/McMaster Innovation Park, Hamilton, Ontario, Canada.'}]",BMJ open,['10.1136/bmjopen-2018-026257'] 661,30260458,"The Effect of Reducing the ""Jumping to Conclusions"" Bias on Treatment Decision-Making Capacity in Psychosis: A Randomized Controlled Trial With Mediation Analysis.","BACKGROUND Evidence-based psychological interventions to support treatment decision-making capacity (capacity) in psychosis do not currently exist. This study sought to establish whether reducing the extent to which this group form conclusions based on limited evidence, also known as the ""jumping-to-conclusions"" (JTC) bias, could improve capacity. METHODS In a randomized controlled open trial, 37 patients aged 16-65 years diagnosed with schizophrenia-spectrum disorders were randomly assigned (1:1) to receive a single-session intervention designed to reduce the JTC bias (MCT-JTC; adapted from Metacognitive Training [MCT]) or an attention control (AC) condition designed to control for therapist attention, duration, modality, and face validity. Primary outcomes were treatment decision-making capacity measured by the MacArthur Competency Assessment Tool for Treatment (MacCAT-T) and the jumping-to-conclusions reasoning bias measured by draws to decision on the beads task, each of which were administered by the psychologist delivering the intervention. RESULTS Those receiving MCT-JTC had large improvements in overall capacity (d = 0.96, P < .05) and appreciation (d = 0.87, P < .05) compared to those receiving AC. Reduction in JTC mediated a large proportion of the effect of group allocation on understanding, appreciation, reasoning, and overall MacCAT-T scores. CONCLUSION This is the first experimental investigation of the effect of a psychological intervention on treatment decision-making capacity in psychosis. It provides early evidence that reducing the JTC bias is associated with large and rapid improvements in capacity. Due to limited resources, assessments were administered by the researchers delivering the intervention. Results should therefore be considered preliminary and a larger, definitive trial addressing methodological limitations is warranted.",2019,"Those receiving MCT-JTC had large improvements in overall capacity (d = 0.96, P < .05) and appreciation (d = 0.87, P < .05) compared to those receiving AC.","['Psychosis', '37 patients aged 16-65 years diagnosed with schizophrenia-spectrum disorders', 'psychosis']","['psychological intervention', 'single-session intervention designed to reduce the JTC bias (MCT-JTC; adapted from Metacognitive Training [MCT]) or an attention control (AC) condition designed to control for therapist attention, duration, modality, and face validity', 'MCT-JTC', 'Jumping to Conclusions"" Bias']","['treatment decision-making capacity measured by the MacArthur Competency Assessment Tool for Treatment (MacCAT-T) and the jumping-to-conclusions reasoning bias measured by draws to decision on the beads task', 'overall capacity']","[{'cui': 'C0033975', 'cui_str': 'Psychoses'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0005346', 'cui_str': 'Bias'}, {'cui': 'C1173173', 'cui_str': 'N-methanocarbathymidine'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0042284', 'cui_str': 'Validity of Results'}, {'cui': 'C0560453', 'cui_str': 'Does jump (finding)'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0011109', 'cui_str': 'Decision Making'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0336791', 'cui_str': 'Tool, device (physical object)'}, {'cui': 'C0684328', 'cui_str': 'Reasoning'}, {'cui': 'C0005346', 'cui_str': 'Bias'}, {'cui': 'C0013113', 'cui_str': 'Drawing'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",37.0,0.100938,"Those receiving MCT-JTC had large improvements in overall capacity (d = 0.96, P < .05) and appreciation (d = 0.87, P < .05) compared to those receiving AC.","[{'ForeName': 'David T', 'Initials': 'DT', 'LastName': 'Turner', 'Affiliation': 'Department of Clinical Psychology, Vrije Universiteit, Amsterdam, The Netherlands.'}, {'ForeName': 'Angus', 'Initials': 'A', 'LastName': 'MacBeth', 'Affiliation': 'Department of Clinical and Health Psychology, School of Health in Social Science, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Larkin', 'Affiliation': 'Psychosis Research Unit, Greater Manchester West Mental Health NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Moritz', 'Affiliation': 'Working Group on Clinical Neuropsychology, Department of Psychiatry and Psychotherapy, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Livingstone', 'Affiliation': 'Clinical Psychology, NHS Lanarkshire, Bothwell, Glasgow, UK.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Campbell', 'Affiliation': 'Clinical Psychology, NHS Lanarkshire, Bothwell, Glasgow, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Hutton', 'Affiliation': 'School of Health and Social Care, Edinburgh Napier University, Edinburgh, UK.'}]",Schizophrenia bulletin,['10.1093/schbul/sby136'] 662,31005674,Moderators of two dual eating disorder and obesity prevention programs.,"Few trials have investigated factors that moderate the effects of eating disorder and obesity prevention programs, which may inform inclusion criteria and intervention refinements. We examined factors hypothesized to moderate the effects of the Healthy Weight eating disorder/obesity prevention program that promotes gradual healthy changes, and Project Health that adds cognitive dissonance activities. College students at risk for both outcomes because of weight concerns (N = 364, 72% female) were randomized to these interventions or an educational video condition, completing pretest, posttest, and 6, 12, and 24-month follow-up assessments. Healthy Weight and Project Health produced significantly larger reductions in eating disorder symptoms versus video controls for individuals with higher negative affect, emotional eating, dietary fat/sugar intake, and perceived pressure to be thin. Project Health also produced significantly less increases in BMI versus video controls for individuals with lower negative affect. Results suggest that these interventions produce larger eating disorder symptom reductions for individuals at elevated risk for eating pathology but hint that weight gain prevention effects may be attenuated by elevated negative affect. Results imply that larger eating disorder symptom reductions will result when implemented with individuals with both weight concerns and one of the additionally identified risk factors.",2019,"Healthy Weight and Project Health produced significantly larger reductions in eating disorder symptoms versus video controls for individuals with higher negative affect, emotional eating, dietary fat/sugar intake, and perceived pressure to be thin.","['College students at risk for both outcomes because of weight concerns (N\u202f=\u202f364, 72% female']",[],"['larger eating disorder symptom reductions', 'eating disorder symptoms', 'BMI', 'eating disorder symptom reductions']","[{'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0086287', 'cui_str': 'Females'}]",[],"[{'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0855228', 'cui_str': 'Eating disorder symptom'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}]",,0.017318,"Healthy Weight and Project Health produced significantly larger reductions in eating disorder symptoms versus video controls for individuals with higher negative affect, emotional eating, dietary fat/sugar intake, and perceived pressure to be thin.","[{'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Stice', 'Affiliation': 'Oregon Research Institute, 1776 Millrace Drive, Eugene, OR, 97403, USA. Electronic address: estice@ori.org.'}, {'ForeName': 'Christopher D', 'Initials': 'CD', 'LastName': 'Desjardins', 'Affiliation': 'Oregon Research Institute, 1776 Millrace Drive, Eugene, OR, 97403, USA.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Shaw', 'Affiliation': 'Oregon Research Institute, 1776 Millrace Drive, Eugene, OR, 97403, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Rohde', 'Affiliation': 'Oregon Research Institute, 1776 Millrace Drive, Eugene, OR, 97403, USA.'}]",Behaviour research and therapy,['10.1016/j.brat.2019.04.002'] 663,31088392,"Randomized, open-label, comparative phase IV study on the bioavailability of Ciclosporin Pro (Teva) versus Sandimmun® Optoral (Novartis) under fasting versus fed conditions in patients with stable renal transplants.","BACKGROUND The influence of pre- or postprandial administration on pharmacokinetics of cyclosporine is supposed to be less in gel-based formulations than in microemulsions. This study was designed to investigate the influence of a high-fat meal on the pharmacokinetic profile of the two cyclosporine containing formulations Ciclosporin Pro (gel-based emulsion) and Sandimmun®Optoral (microemulsion) in renal transplant recipients. METHODS A randomized, open-label, repeated-measurement, comparative phase IV trial was conducted with two sequence groups for nutrition condition (fasting→fed, fed→fasting) and two treatment phases (Sandimmun® Optoral → Ciclosporin Pro), each covering both nutrition conditions. Primary pharmacokinetic variable of interest was the reduction of bioavailability due to high-fat food compared to fasting conditions measured by the difference D of ln-transformed bioavailability variables (AUC SS, τ , C ss, max , und C ss, min ). RESULTS A nutrition effect was found for both study medications with respect to the parameters AUC SS, τ and C SS, max , but not to C SS, min . The reduction of bioavailability caused by high-fat food was not significantly different for Sandimmun®Optoral and Ciclosporin Pro. CONCLUSIONS An effect of high-fat breakfast prior to the morning dose on AUC SS, τ and C SS, max was found for Sandimmun® Optoral and for Ciclosporin Pro . Trough level monitoring did not capture ingestion-related variability. Conversion to Ciclosporin Pro seems to be safe with regard to intra-individual pharmacokinetic variability. TRIAL REGISTRATION EudraCT No. 2009-011354-18 (29th April 2019).",2019,"The reduction of bioavailability caused by high-fat food was not significantly different for Sandimmun®Optoral and Ciclosporin Pro. ","['patients with stable renal transplants', 'renal transplant recipients']","['cyclosporine containing formulations Ciclosporin Pro (gel-based emulsion) and Sandimmun®Optoral (microemulsion', 'EudraCT', 'Ciclosporin Pro (Teva) versus Sandimmun® Optoral (Novartis) under fasting versus fed conditions', 'cyclosporine']","['bioavailability variables (AUC SS, τ , C ss, max , und C ss, min ', 'AUC SS, τ and C SS, max', 'reduction of bioavailability']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0022671', 'cui_str': 'Grafting, Kidney'}]","[{'cui': 'C0010594', 'cui_str': 'Cyclosporins'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0010592', 'cui_str': 'cyclosporine A'}, {'cui': 'C0017243', 'cui_str': 'Gel (basic dose form)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0014020', 'cui_str': 'Emulsions'}, {'cui': 'C0699604', 'cui_str': 'Sandimmune'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C2987508', 'cui_str': 'Feeding (observable entity)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C0005508', 'cui_str': 'Bioavailability'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}]",,0.0123003,"The reduction of bioavailability caused by high-fat food was not significantly different for Sandimmun®Optoral and Ciclosporin Pro. ","[{'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'Gäckler', 'Affiliation': 'Department of Nephrology, University Hospital Essen, University Duisburg-Essen, Hufelandstr. 55, 45147, Essen, Germany. anja.gaeckler@uk-essen.de.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Dolff', 'Affiliation': 'Department of Infectious Diseases, University Hospital Essen, University Duisburg-Essen, Hufelandstr. 55, 45147, Essen, Germany.'}, {'ForeName': 'Hana', 'Initials': 'H', 'LastName': 'Rohn', 'Affiliation': 'Department of Infectious Diseases, University Hospital Essen, University Duisburg-Essen, Hufelandstr. 55, 45147, Essen, Germany.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Korth', 'Affiliation': 'Department of Nephrology, University Hospital Essen, University Duisburg-Essen, Hufelandstr. 55, 45147, Essen, Germany.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Wilde', 'Affiliation': 'Department of Nephrology, University Hospital Essen, University Duisburg-Essen, Hufelandstr. 55, 45147, Essen, Germany.'}, {'ForeName': 'Ute', 'Initials': 'U', 'LastName': 'Eisenberger', 'Affiliation': 'Department of Nephrology, University Hospital Essen, University Duisburg-Essen, Hufelandstr. 55, 45147, Essen, Germany.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Mitchell', 'Affiliation': 'Department of Nephrology, University Hospital Essen, University Duisburg-Essen, Hufelandstr. 55, 45147, Essen, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Kribben', 'Affiliation': 'Department of Nephrology, University Hospital Essen, University Duisburg-Essen, Hufelandstr. 55, 45147, Essen, Germany.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Witzke', 'Affiliation': 'Department of Infectious Diseases, University Hospital Essen, University Duisburg-Essen, Hufelandstr. 55, 45147, Essen, Germany.'}]",BMC nephrology,['10.1186/s12882-019-1340-z'] 664,31628490,Bone mineral density gains with a second 12-month course of romosozumab therapy following placebo or denosumab.,"Romosozumab is a therapy that stimulates bone formation and reduces bone resorption. In this study of postmenopausal women with low BMD, a second course of romosozumab following a period off treatment or on denosumab increased or maintained BMD, respectively, and was well tolerated, providing insight into treatment sequence options. INTRODUCTION In patients with high fracture risk, therapies that stimulate bone formation provide rapid BMD gains; currently available agents, parathyroid hormone receptor agonists, are limited to a 2-year lifetime exposure and generally used for a single treatment course. However, for long-term osteoporosis management, a second treatment course may be appropriate. Romosozumab, a therapy with the dual effect of increasing bone formation and decreasing bone resorption, reduces fracture risk within 12 months. Here, we report efficacy and safety of a second romosozumab course. METHODS In this phase 2, dose-finding study, postmenopausal women with low bone mass (T-score ≤ - 2.0 and ≥ - 3.5) received romosozumab or placebo (month 0-24) followed by placebo or denosumab (month 24-36); participants then received a year of romosozumab (month 36-48). RESULTS Of 167 participants who entered the month 36-48 period, 35 had been initially randomized to romosozumab 210 mg monthly. In participants who received romosozumab 210 mg monthly followed by placebo, a second romosozumab course (n = 19) increased BMD by amounts similar to their initial treatment (month 0-12) at the lumbar spine (12.4%; 12.0%, respectively) and total hip (6.0%; 5.5%, respectively). Following denosumab, a second romosozumab course (n = 16) increased BMD at the lumbar spine (2.3%) and maintained BMD at the total hip. Safety profiles were similar between first and second romosozumab courses. CONCLUSIONS After 12 months off-treatment, a second romosozumab course again led to rapid and large BMD gains. Following denosumab, BMD gains with romosozumab were smaller than with initial treatment. No new safety findings were observed during the second course.",2019,"Safety profiles were similar between first and second romosozumab courses. ","['patients with high fracture risk', 'postmenopausal women with low BMD', 'postmenopausal women with low bone mass (T-score\u2009≤\u2009-\u20092.0 and ≥\u2009-\u20093.5) received', '167 participants who entered the month 36-48 period']","['placebo or denosumab', 'romosozumab 210\xa0mg monthly followed by placebo', 'romosozumab therapy following placebo or denosumab', 'romosozumab', 'Romosozumab', 'romosozumab or placebo', 'denosumab']","['BMD', 'bone resorption', 'Safety profiles', 'BMD gains with romosozumab', 'Bone mineral density gains', 'BMD at the lumbar spine', 'bone formation and decreasing bone resorption, reduces fracture risk']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C3854607', 'cui_str': 'T score'}, {'cui': 'C3844010', 'cui_str': '3.5'}, {'cui': 'C4517595', 'cui_str': '167 (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1690432', 'cui_str': 'denosumab'}, {'cui': 'C3661283'}, {'cui': 'C4319559', 'cui_str': '210'}, {'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}]","[{'cui': 'C0005974', 'cui_str': 'Osteoclastic Bone Loss'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C3661283'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C3887615', 'cui_str': 'Lumbar spine structure (body structure)'}, {'cui': 'C0029433', 'cui_str': 'Ossification'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",167.0,0.05311,"Safety profiles were similar between first and second romosozumab courses. ","[{'ForeName': 'D L', 'Initials': 'DL', 'LastName': 'Kendler', 'Affiliation': 'Department of Medicine, University of British Columbia, 150-943 West Broadway, Vancouver, BC, V5Z 4E1, Canada. davidkendler@gmail.com.'}, {'ForeName': 'H G', 'Initials': 'HG', 'LastName': 'Bone', 'Affiliation': 'Michigan Bone and Mineral Clinic, Detroit, MI, USA.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Massari', 'Affiliation': 'Instituto de Investigaciones Metabólicas, Buenos Aires, Argentina.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Gielen', 'Affiliation': 'UZ Leuven, Leuven, Belgium.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Palacios', 'Affiliation': 'Instituto Palacios, Madrid, Spain.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Maddox', 'Affiliation': 'Amgen Inc., Thousand Oaks, CA, USA.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Yan', 'Affiliation': 'Amgen Ltd., Cambridge, UK.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Yue', 'Affiliation': 'Amgen Inc., Thousand Oaks, CA, USA.'}, {'ForeName': 'R V', 'Initials': 'RV', 'LastName': 'Dinavahi', 'Affiliation': 'Amgen Inc., Thousand Oaks, CA, USA.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Libanati', 'Affiliation': 'UCB Pharma, Brussels, Belgium.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Grauer', 'Affiliation': 'Amgen Inc., Thousand Oaks, CA, USA.'}]",Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA,['10.1007/s00198-019-05146-9'] 665,31196016,Evaluation of long-term effectiveness of the use of carglumic acid in patients with propionic acidemia (PA) or methylmalonic acidemia (MMA): study protocol for a randomized controlled trial.,"INTRODUCTION Propionic acidemia (PA) and methylmalonic acidemia (MMA) are rare autosomal recessive inborn errors of metabolism characterized by hyperammonemia due to N-acetylglutamate synthase (NAGS) dysfunction. Carglumic acid (Carbaglu®; Orphan Europe Ltd.) is approved by the US Food and Drug Administration (USFDA) for the treatment of hyperammonemia due hepatic NAGS deficiency. Here we report the rationale and design of a phase IIIb trial that is aimed at determining the long-term efficacy and safety of carglumic acid in the management of PA and MMA. METHODS This prospective, multicenter, open-label, randomized, parallel group phase IIIb study will be conducted in Saudi Arabia. Patients with PA or MMA (≤15 years of age) will be randomized 1:1 to receive twice daily carglumic acid (50 mg/kg/day) plus standard therapy (protein-restricted diet, L-carnitine, and metronidazole) or standard therapy alone for a 2-year treatment period. The primary efficacy outcome is the number of emergency room visits due to hyperammonemia. Safety will be assessed throughout the study and during the 1 month follow-up period after the study. DISCUSSION Current guidelines recommend conservative medical treatment as the main strategy for the management of PA and MMA. Although retrospective studies have suggested that long-term carglumic acid may be beneficial in the management of PA and MMA, current literature lacks evidence for this indication. This clinical trial will determine the long-term safety and efficacy of carglumic acid in the management of PA and MMA. TRIAL REGISTRATION King Abdullah International Medical Research Center ( KAIMRC ): (RC13/116) 09/1/2014. Saudi Food and Drug Authority (SFDA) (33066) 08/14/2014. ClinicalTrials.gov (identifier: NCT02426775) 04/22/2015.",2019,"Although retrospective studies have suggested that long-term carglumic acid may be beneficial in the management of PA and MMA, current literature lacks evidence for this indication.","['patients with propionic acidemia (PA) or methylmalonic acidemia (MMA', 'Patients with PA or MMA (≤15\u2009years of age', 'Saudi Arabia']","['Propionic acidemia (PA) and methylmalonic acidemia (MMA', 'carglumic acid', 'twice daily carglumic acid (50\u2009mg/kg/day) plus standard therapy (protein-restricted diet, L-carnitine, and metronidazole) or standard therapy alone']",['number of emergency room visits due to hyperammonemia'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0268579', 'cui_str': 'Ketotic Hyperglycinemia'}, {'cui': 'C0268583', 'cui_str': 'Isolated Methylmalonic Acidemia'}, {'cui': 'C0916871', 'cui_str': 'MMA(III)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0036243', 'cui_str': 'Kingdom of Saudi Arabia'}]","[{'cui': 'C0268579', 'cui_str': 'Ketotic Hyperglycinemia'}, {'cui': 'C0268583', 'cui_str': 'Isolated Methylmalonic Acidemia'}, {'cui': 'C0916871', 'cui_str': 'MMA(III)'}, {'cui': 'C1318649', 'cui_str': 'Carglumic acid'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}, {'cui': 'C3665414', 'cui_str': 'mg/kg/day'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0242972', 'cui_str': 'Low-Protein Diet'}, {'cui': 'C0087163', 'cui_str': 'l-carnitine'}, {'cui': 'C0025872', 'cui_str': 'Metronidazole'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0220994', 'cui_str': 'Hyperammonemia'}]",,0.0672122,"Although retrospective studies have suggested that long-term carglumic acid may be beneficial in the management of PA and MMA, current literature lacks evidence for this indication.","[{'ForeName': 'Marwan', 'Initials': 'M', 'LastName': 'Nashabat', 'Affiliation': 'Genetics Division, Department of Pediatrics, King Abdullah International Medical Research Centre, King Saud bin Abdulaziz University for Health Science, King Abdulaziz Medical City, Ministry of National Guard-Health Affairs (NGHA), PO Box 22490 11426, Riyadh, Saudi Arabia.'}, {'ForeName': 'Abdulrahman', 'Initials': 'A', 'LastName': 'Obaid', 'Affiliation': 'Genetics Division, Department of Pediatrics, King Abdullah International Medical Research Centre, King Saud bin Abdulaziz University for Health Science, King Abdulaziz Medical City, Ministry of National Guard-Health Affairs (NGHA), PO Box 22490 11426, Riyadh, Saudi Arabia.'}, {'ForeName': 'Fuad', 'Initials': 'F', 'LastName': 'Al Mutairi', 'Affiliation': 'Genetics Division, Department of Pediatrics, King Abdullah International Medical Research Centre, King Saud bin Abdulaziz University for Health Science, King Abdulaziz Medical City, Ministry of National Guard-Health Affairs (NGHA), PO Box 22490 11426, Riyadh, Saudi Arabia.'}, {'ForeName': 'Mohammed', 'Initials': 'M', 'LastName': 'Saleh', 'Affiliation': ""Medical Genetic Section, King Fahad Medical City, Children's Hospital, Riyadh, Saudi Arabia.""}, {'ForeName': 'Mohammed', 'Initials': 'M', 'LastName': 'Elamin', 'Affiliation': ""Medical Genetic Section, King Fahad Medical City, Children's Hospital, Riyadh, Saudi Arabia.""}, {'ForeName': 'Hind', 'Initials': 'H', 'LastName': 'Ahmed', 'Affiliation': 'Genetics Division, Department of Pediatrics, King Abdullah International Medical Research Centre, King Saud bin Abdulaziz University for Health Science, King Abdulaziz Medical City, Ministry of National Guard-Health Affairs (NGHA), PO Box 22490 11426, Riyadh, Saudi Arabia.'}, {'ForeName': 'Faroug', 'Initials': 'F', 'LastName': 'Ababneh', 'Affiliation': 'Genetics Division, Department of Pediatrics, King Abdullah International Medical Research Centre, King Saud bin Abdulaziz University for Health Science, King Abdulaziz Medical City, Ministry of National Guard-Health Affairs (NGHA), PO Box 22490 11426, Riyadh, Saudi Arabia.'}, {'ForeName': 'Wafaa', 'Initials': 'W', 'LastName': 'Eyaid', 'Affiliation': 'Genetics Division, Department of Pediatrics, King Abdullah International Medical Research Centre, King Saud bin Abdulaziz University for Health Science, King Abdulaziz Medical City, Ministry of National Guard-Health Affairs (NGHA), PO Box 22490 11426, Riyadh, Saudi Arabia.'}, {'ForeName': 'Abdulrahman', 'Initials': 'A', 'LastName': 'Alswaid', 'Affiliation': 'Genetics Division, Department of Pediatrics, King Abdullah International Medical Research Centre, King Saud bin Abdulaziz University for Health Science, King Abdulaziz Medical City, Ministry of National Guard-Health Affairs (NGHA), PO Box 22490 11426, Riyadh, Saudi Arabia.'}, {'ForeName': 'Lina', 'Initials': 'L', 'LastName': 'Alohali', 'Affiliation': 'Genetics Division, Department of Pediatrics, King Abdullah International Medical Research Centre, King Saud bin Abdulaziz University for Health Science, King Abdulaziz Medical City, Ministry of National Guard-Health Affairs (NGHA), PO Box 22490 11426, Riyadh, Saudi Arabia.'}, {'ForeName': 'Eissa', 'Initials': 'E', 'LastName': 'Faqeih', 'Affiliation': ""Medical Genetic Section, King Fahad Medical City, Children's Hospital, Riyadh, Saudi Arabia.""}, {'ForeName': 'Majed', 'Initials': 'M', 'LastName': 'Aljeraisy', 'Affiliation': 'King Abdullah International Medical Research Centre, King Saud bin Abdulaziz University for Health Science, College of Pharmacy, King Abdulaziz Medical City, Ministry of National Guard-Health Affairs, Riyadh, Saudi Arabia.'}, {'ForeName': 'Mohamed A', 'Initials': 'MA', 'LastName': 'Hussein', 'Affiliation': 'Department Biostatistics and Bioinformatics, King Abdullah International Medical Research Centre, King Saud bin Abdulaziz University for Health Science, Ministry of National Guard-Health Affairs, Riyadh, Saudi Arabia.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Alasmari', 'Affiliation': ""Medical Genetic Section, King Fahad Medical City, Children's Hospital, Riyadh, Saudi Arabia.""}, {'ForeName': 'Majid', 'Initials': 'M', 'LastName': 'Alfadhel', 'Affiliation': 'Genetics Division, Department of Pediatrics, King Abdullah International Medical Research Centre, King Saud bin Abdulaziz University for Health Science, King Abdulaziz Medical City, Ministry of National Guard-Health Affairs (NGHA), PO Box 22490 11426, Riyadh, Saudi Arabia. dralfadhelm@gmail.com.'}]",BMC pediatrics,['10.1186/s12887-019-1571-y'] 666,30597771,"PF-04447943, a Phosphodiesterase 9A Inhibitor, in Stable Sickle Cell Disease Patients: A Phase Ib Randomized, Placebo-Controlled Study.","This phase Ib study randomized patients with stable sickle cell disease (SCD) aged 18-65 years to twice-daily PF-04447943 (a phosphodiesterase 9A inhibitor; 5 or 25 mg) or placebo, with/without hydroxyurea coadministration, for up to 29 days. Blood samples were collected at baseline and various posttreatment time points for assessments of PF-04447943 pharmacokinetics (PKs)/pharmacodynamics (PDs). Change from baseline in potential SCD-related biomarkers was evaluated. Of 30 patients, 15 received hydroxyurea and 28 completed the study. PF-04447943, with/without hydroxyurea, was generally well tolerated, with no treatment-related serious adverse events. Plasma PF-04447943 exposure was dose proportional. Twice-daily PF-04447943 25 mg significantly reduced the number and size of circulating monocyte-platelet and neutrophil-platelet aggregates and levels of circulating soluble E-selectin at day 29 vs. baseline (adjusted P < 0.15). PF-04447943 demonstrated PK/PD effects suggestive of inhibiting pathways that may contribute to vaso-occlusion. This study also provides guidance regarding biomarkers for future SCD studies.",2019,Twice-daily PF-04447943 25 mg significantly reduced the number and size of circulating monocyte-platelet and neutrophil-platelet aggregates and levels of circulating soluble E-selectin at day 29 vs. baseline (adjusted P ,"['patients with stable sickle cell disease (SCD) aged 18-65\xa0years to twice-daily PF-04447943 (a phosphodiesterase 9A inhibitor; 5 or 25\xa0mg) or', '30 patients, 15 received', 'Stable Sickle Cell Disease Patients']","['Placebo', 'hydroxyurea', 'placebo, with/without hydroxyurea coadministration']","['number and size of circulating monocyte-platelet and neutrophil-platelet aggregates and levels of circulating soluble E-selectin', 'Blood samples', 'PF-04447943 pharmacokinetics (PKs)/pharmacodynamics (PDs']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0002895', 'cui_str': 'Sickle Cell Disease'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}, {'cui': 'C3492319', 'cui_str': 'PF-04447943'}, {'cui': 'C4522025', 'cui_str': 'Phosphodiesterase'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0020402', 'cui_str': 'hydroxyurea'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}, {'cui': 'C0026473', 'cui_str': 'Monocytes'}, {'cui': 'C0005821', 'cui_str': 'Platelets'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear Leukocytes'}, {'cui': 'C0205418', 'cui_str': 'Aggregate (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0115305', 'cui_str': 'LECAM-2'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C3492319', 'cui_str': 'PF-04447943'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}]",,0.0675021,Twice-daily PF-04447943 25 mg significantly reduced the number and size of circulating monocyte-platelet and neutrophil-platelet aggregates and levels of circulating soluble E-selectin at day 29 vs. baseline (adjusted P ,"[{'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Charnigo', 'Affiliation': 'Pfizer, Inc., Collegeville, Pennsylvania, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Beidler', 'Affiliation': 'Pfizer, Inc., Cambridge, Massachusetts, USA.'}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Rybin', 'Affiliation': 'Pfizer, Inc., Cambridge, Massachusetts, USA.'}, {'ForeName': 'Debra D', 'Initials': 'DD', 'LastName': 'Pittman', 'Affiliation': 'Pfizer, Inc., Cambridge, Massachusetts, USA.'}, {'ForeName': 'Beesan', 'Initials': 'B', 'LastName': 'Tan', 'Affiliation': 'Pfizer, Inc., Cambridge, Massachusetts, USA.'}, {'ForeName': 'Jo', 'Initials': 'J', 'LastName': 'Howard', 'Affiliation': ""Guy's and St. Thomas' Hospital, Great Maze Pond, London, UK.""}, {'ForeName': 'Alan D', 'Initials': 'AD', 'LastName': 'Michelson', 'Affiliation': ""Center for Platelet Research Studies, Dana-Farber/Boston Children's Cancer and Blood Disorders Center, Boston, Massachusetts, USA.""}, {'ForeName': 'Andrew L', 'Initials': 'AL', 'LastName': 'Frelinger', 'Affiliation': ""Center for Platelet Research Studies, Dana-Farber/Boston Children's Cancer and Blood Disorders Center, Boston, Massachusetts, USA.""}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Clarke', 'Affiliation': 'Pfizer, Inc., Cambridge, Massachusetts, USA.'}]",Clinical and translational science,['10.1111/cts.12604'] 667,32151333,"De-implementation strategy to reduce inappropriate use of intravenous and urinary catheters (RICAT): a multicentre, prospective, interrupted time-series and before and after study.","BACKGROUND Catheter-associated bloodstream infections and urinary tract infections are frequently encountered health care-associated infections. We aimed to reduce inappropriate use of catheters to reduce health care-associated infections. METHODS In this multicentre, interrupted time-series and before and after study, we introduced a de-implementation strategy with multifaceted interventions in seven hospitals in the Netherlands. Adult patients admitted to internal medicine, gastroenterology, geriatic, oncology, or pulmonology wards, and non-surgical acute admission units, and who had a (central or peripheral) venous or urinary catheter were eligible for inclusion. One of the interventions was that nurses in the participating wards attended educational meetings on appropriate catheter use. Data on catheter use were collected every 2 weeks by the primary research physician during the baseline period (7 months) and intervention period (7 months), which were separated by a 5 month transition period. The primary outcomes were percentages of short peripheral intravenous catheters and urinary catheters used inappropriately on the days of data collection. Indications for catheter use were based on international guidelines. This study is registered with Netherlands Trial Register, NL5438. FINDINGS Between Sept 1, 2016, and April 1, 2018, we screened 6157 patients for inclusion, of whom 5696 were enrolled: 2650 patients in the baseline group, and 3046 in the intervention group. Inappropriate use of peripheral intravenous catheters occurred in 366 (22·0%, 95% CI 20·0 to 24·0) of 1665 patients in the baseline group and in 275 (14·4%, 12·8 to 16·0) of 1912 patients in the intervention group (incidence rate ratio [IRR] 0·65, 95% CI 0·56 to 0·77, p<0·0001). Time-series analyses showed an absolute reduction in inappropriate use of peripheral intravenous catheters from baseline to intervention periods of 6·65% (95% CI 2·47 to 10·82, p=0·011). Inappropriate use of urinary catheters occurred in 105 (32·4%, 95% CI 27·3 to 37·8) of 324 patients in the baseline group compared with 96 (24·1%, 20·0 to 28·6) of 398 patients in the intervention group (IRR 0·74, 95% CI 0·56 to 0·98, p=0·013). Time-series analyses showed an absolute reduction in inappropriate use of urinary catheters of 6·34% (95% CI -12·46 to 25·13, p=0·524). INTERPRETATION Our de-implementation strategy reduced inappropriate use of short peripheral intravenous catheters in patients who were not in the intensive care unit. The reduction of inappropriate use of urinary catheters was substantial, yet not statistically significant in time-series analysis due to a small sample size. The strategy appears well suited for broad-scale implementation to reduce health care-associated infections. FUNDING Netherlands Organisation for Health Research and Development.",2020,"The reduction of inappropriate use of urinary catheters was substantial, yet not statistically significant in time-series analysis due to a small sample size.","['patients who were not in the intensive care unit', '6157 patients for inclusion, of whom 5696 were enrolled: 2650 patients in the baseline group, and 3046 in the intervention group', 'Adult patients admitted to internal medicine, gastroenterology, geriatic, oncology, or pulmonology wards, and non-surgical acute admission units, and who had a (central or peripheral) venous or urinary catheter were eligible for inclusion', 'seven hospitals in the Netherlands', 'Between Sept 1, 2016, and April 1, 2018']",['intravenous and urinary catheters (RICAT'],"['incidence rate ratio [IRR', 'Inappropriate use of peripheral intravenous catheters', 'percentages of short peripheral intravenous catheters and urinary catheters used inappropriately on the days of data collection', 'Inappropriate use of urinary catheters']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0021782', 'cui_str': 'Internal Medicine'}, {'cui': 'C0017163', 'cui_str': 'Gastroenterology'}, {'cui': 'C0034060', 'cui_str': 'Pneumology'}, {'cui': 'C1305702', 'cui_str': 'Ward (environment)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0205100', 'cui_str': 'Peripheral (qualifier value)'}, {'cui': 'C0348013', 'cui_str': 'Venous (qualifier value)'}, {'cui': 'C0179802', 'cui_str': 'Urinary catheter, device (physical object)'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0179802', 'cui_str': 'Urinary catheter, device (physical object)'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0083017', 'cui_str': 'IRR'}, {'cui': 'C3542467', 'cui_str': 'Inappropriate component (foundation metadata concept)'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0179768', 'cui_str': 'Peripheral intravenous catheter, device (physical object)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0179802', 'cui_str': 'Urinary catheter, device (physical object)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0010995', 'cui_str': 'Data Collection'}]",6157.0,0.0611152,"The reduction of inappropriate use of urinary catheters was substantial, yet not statistically significant in time-series analysis due to a small sample size.","[{'ForeName': 'Bart J', 'Initials': 'BJ', 'LastName': 'Laan', 'Affiliation': 'Infectious Diseases, Internal Medicine, Amsterdam UMC, University of Amsterdam, Amsterdam, Netherlands. Electronic address: b.j.laan@amsterdamumc.nl.'}, {'ForeName': 'Jolanda M', 'Initials': 'JM', 'LastName': 'Maaskant', 'Affiliation': 'Clinical Epidemiology, Biostatistics, and Bioinformatics, Amsterdam UMC, University of Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Ingrid J B', 'Initials': 'IJB', 'LastName': 'Spijkerman', 'Affiliation': 'Medical Microbiology, Amsterdam UMC, University of Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Marjon J', 'Initials': 'MJ', 'LastName': 'Borgert', 'Affiliation': 'Internal Medicine, Amsterdam UMC, University of Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Mieke H', 'Initials': 'MH', 'LastName': 'Godfried', 'Affiliation': 'Internal Medicine, Amsterdam UMC, University of Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Berend C', 'Initials': 'BC', 'LastName': 'Pasmooij', 'Affiliation': 'Internal Medicine, Amsterdam UMC, University of Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Brent C', 'Initials': 'BC', 'LastName': 'Opmeer', 'Affiliation': 'Clinical Research Unit, Amsterdam UMC, University of Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Margreet C', 'Initials': 'MC', 'LastName': 'Vos', 'Affiliation': 'Medical Microbiology and Infectious Diseases, Erasmus University Medical Centre, Rotterdam, Netherlands.'}, {'ForeName': 'Suzanne E', 'Initials': 'SE', 'LastName': 'Geerlings', 'Affiliation': 'Infectious Diseases, Internal Medicine, Amsterdam UMC, University of Amsterdam, Amsterdam, Netherlands.'}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(19)30709-1'] 668,31799505,Acute Stress Increases Intraocular Pressure in Nonhuman Primates.,"Purpose To quantify intraocular pressure (IOP) change and time course during stressful activity. Study Design Experimental Study. Subjects Three nonhuman primates (NHPs). Methods Bilateral IOP and aortic blood pressure (BP) were recorded continuously, then averaged for periods of 8-30 seconds before, during, and after a common anesthetic induction procedure (cage squeeze followed by intramuscular injection). Experiments were repeated four times in each NHP. Main Outcome Measures IOP, BP, and heart rate (HR) change during an anesthetic induction procedure. Results IOP, mean arterial pressure (MAP), and HR increased rapidly and significantly by 27%, 38%, 34%, respectively, in anticipation of anesthetic induction (Figure; p <0.05). IOP rose ~10% within 10 seconds of hearing the technician enter the outer anteroom door, and reached its maximum within ~1 minute of first anticipating human contact. IOP fell to below baseline levels within 1 minute after anesthetic induction. Conclusions IOP increases rapidly and significantly in response to stressful situations in the nonhuman primate.",2019,", mean arterial pressure (MAP), and HR increased rapidly and significantly by 27%, 38%, 34%, respectively, in anticipation of anesthetic induction (Figure; p <0.05).",['Subjects\n\n\nThree nonhuman primates (NHPs'],['IOP'],"['IOP, BP, and heart rate (HR) change during an anesthetic induction procedure', 'mean arterial pressure (MAP), and HR increased rapidly', 'Bilateral IOP and aortic blood pressure (BP', 'intraocular pressure (IOP) change and time course']","[{'cui': 'C0033147', 'cui_str': 'Primates'}]",[],"[{'cui': 'C0232189', 'cui_str': 'Alteration in heart rate'}, {'cui': 'C0853212', 'cui_str': 'Induction of anesthesia'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0428886', 'cui_str': 'Mean Arterial Pressure'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0456180', 'cui_str': 'Aortic Blood Pressure'}, {'cui': 'C0021888', 'cui_str': 'Ocular Tension'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0449247', 'cui_str': 'Time course (attribute)'}]",,0.13713,", mean arterial pressure (MAP), and HR increased rapidly and significantly by 27%, 38%, 34%, respectively, in anticipation of anesthetic induction (Figure; p <0.05).","[{'ForeName': 'Daniel C', 'Initials': 'DC', 'LastName': 'Turner', 'Affiliation': 'Department of Vision Sciences, School of Optometry, University of Alabama at Birmingham, Birmingham, Alabama, USA.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Miranda', 'Affiliation': 'The University of Texas M.D. Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Jeffrey S', 'Initials': 'JS', 'LastName': 'Morris', 'Affiliation': 'The University of Texas M.D. Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Christopher A', 'Initials': 'CA', 'LastName': 'Girkin', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, School of Medicine, University of Alabama at Birmingham, Birmingham, Alabama, USA.'}, {'ForeName': 'J Crawford', 'Initials': 'JC', 'LastName': 'Downs', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, School of Medicine, University of Alabama at Birmingham, Birmingham, Alabama, USA.'}]",Ophthalmology. Glaucoma,['10.1016/j.ogla.2019.03.010'] 669,31870666,Digital Management of Hypertension Improves Systolic Blood Pressure Variability.,"BACKGROUND Higher systolic blood pressure variability has been shown to be a better predictor of all-cause and cardiovascular disease mortality, stroke, and cardiac disease compared with average systolic blood pressure. METHODS We evaluated the impact of a digital hypertension program on systolic blood pressure variability in 803 consecutive patients with long-standing hypertension who had been under the care of a primary care physician for a minimum of 12 months prior to enrollment (mean 4.7 years). Blood pressure readings were transmitted directly from home using a digitally connected blood pressure unit. Medication adjustments and lifestyle coaching was performed virtually via a dedicated team of pharmacists and health coaches. Systolic blood pressure variability was grouped by quartile and measured using the standard deviation (SD) of all systolic blood pressure values per individual. RESULTS The mean age was 67 ± 12 years, 41% were male, submitting 3.3 ± 3.7 blood pressures per week. Under usual care, only 30% of patients were in the lowest-risk quartile, and 21% of patients were in the highest risk. After 24 months, the mean systolic blood pressure variability progressively fell from 12.8 ± 4.3 mm Hg to 9.9 ± 5.1 mm Hg (P <0.0001) with 57% of patients achieving the lowest-risk quartile. CONCLUSIONS The majority of patients with hypertension under usual care have elevated systolic blood pressure variability exposing them to higher risk of cardiovascular disease events. Digital management of hypertension that includes weekly submission of home readings leads to improvement in average systolic blood pressure as well as systolic blood pressure variability over time, which should improve cardiovascular prognosis.",2020,"After 24 months, the mean systolic blood pressure variability progressively fell from 12.8±4.3 mmHg to 9.9±5.1 mmHg (p<0.0001) with 57% of patients achieving the lowest risk quartile. ","['The mean age was 67±12 years, 41% were male, submitting 3.3±3.7 blood pressures per week', '803 consecutive patients with long-standing hypertension who had been under the care of a primary care physician for a minimum of 12 months prior to enrollment (mean 4.7 years']",['digital hypertension program'],"['Systolic Blood Pressure Variability', 'systolic blood pressure variability', 'average systolic blood pressure', 'mean systolic blood pressure variability', 'systolic blood pressure values per individual', 'Blood pressure readings', 'Systolic blood pressure variability']","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0033131', 'cui_str': 'Primary Care Physicians'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}]","[{'cui': 'C0442015', 'cui_str': 'Digital X-ray (qualifier value)'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C1282151', 'cui_str': 'Average systolic blood pressure'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}]",803.0,0.0248688,"After 24 months, the mean systolic blood pressure variability progressively fell from 12.8±4.3 mmHg to 9.9±5.1 mmHg (p<0.0001) with 57% of patients achieving the lowest risk quartile. ","[{'ForeName': 'Richard V', 'Initials': 'RV', 'LastName': 'Milani', 'Affiliation': 'Center for Healthcare Innovation, Ochsner Health System, New Orleans, La; Department of Cardiovascular Diseases, John Ochsner Heart and Vascular Institute, Ochsner Clinical School, University of Queensland School of Medicine, New Orleans, La. Electronic address: rmilani@ochsner.org.'}, {'ForeName': 'Jonathan K', 'Initials': 'JK', 'LastName': 'Wilt', 'Affiliation': 'Center for Healthcare Innovation, Ochsner Health System, New Orleans, La.'}, {'ForeName': 'Alexander R', 'Initials': 'AR', 'LastName': 'Milani', 'Affiliation': 'Emory University School of Medicine, Atlanta, Ga.'}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Bober', 'Affiliation': 'Center for Healthcare Innovation, Ochsner Health System, New Orleans, La; Department of Cardiovascular Diseases, John Ochsner Heart and Vascular Institute, Ochsner Clinical School, University of Queensland School of Medicine, New Orleans, La.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Malamud', 'Affiliation': 'Center for Healthcare Innovation, Ochsner Health System, New Orleans, La.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Entwisle', 'Affiliation': 'Center for Healthcare Innovation, Ochsner Health System, New Orleans, La.'}, {'ForeName': 'Carl J', 'Initials': 'CJ', 'LastName': 'Lavie', 'Affiliation': 'Department of Cardiovascular Diseases, John Ochsner Heart and Vascular Institute, Ochsner Clinical School, University of Queensland School of Medicine, New Orleans, La.'}]",The American journal of medicine,['10.1016/j.amjmed.2019.10.043'] 670,30535623,"A Randomized, Controlled Trial of the Impact of the Couple CARE for Parents of Newborns Program on the Prevention of Intimate Partner Violence and Relationship Problems.","Effective, accessible prevention programs are needed for adults at heightened risk for intimate partner violence (IPV). This parallel group randomized controlled trial examines whether such couples receiving the American version of Couple CARE for Parents of Newborns (CCP; Halford et al. 2009) following the birth of a child, compared with controls, report fewer first occurrences of clinically significant IPV, less frequent physical and psychological IPV, and improved relationship functioning. Further, we test whether intervention effects are moderated by level of risk for IPV. Couples at elevated risk for IPV (N = 368) recruited from maternity units were randomized to CCP (n = 188) or a 24-month waitlist (n = 180) and completed measures of IPV and relationship functioning at baseline, post-program (when child was 8 months old), and two follow-ups (at 15 and 24 months). Intervention effects were tested using intent to treat (ITT) as well as complier average causal effect (CACE; Jo and Muthén 2001) structural equation models. CCP did not significantly prevent clinically significant IPV nor were there significant main effects of CCP on clinically significant IPV, frequency of IPV, or most relationship outcomes in the CACE or ITT analyses. Risk moderated the effect of CCP on male-to-female physical IPV at post-program, with couples with a planned pregnancy declining, but those with unplanned pregnancies increasing. This study adds to previous findings that prevention programs for at-risk couples are not often effective and may even be iatrogenic for some couples.",2019,"CCP did not significantly prevent clinically significant IPV nor were there significant main effects of CCP on clinically significant IPV, frequency of IPV, or most relationship outcomes in the CACE or ITT analyses.","['Parents of Newborns Program on the Prevention of Intimate Partner Violence and Relationship Problems', 'couples receiving the American version of Couple CARE for Parents of Newborns (CCP; Halford et al', 'Couples at elevated risk for IPV (N\u2009=\u2009368) recruited from maternity units', 'adults at heightened risk for intimate partner violence (IPV']","['Couple CARE', 'CCP']","['frequent physical and psychological IPV, and improved relationship functioning']","[{'cui': 'C0030551', 'cui_str': 'Parent of (observable entity)'}, {'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}, {'cui': 'C0425168', 'cui_str': 'Relationship problems (finding)'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0276240', 'cui_str': 'Infectious pustular vulvovaginitis (disorder)'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0442803', 'cui_str': 'Heightened (qualifier value)'}]","[{'cui': 'C0010222', 'cui_str': 'Couples'}]","[{'cui': 'C0332183', 'cui_str': 'Frequent (qualifier value)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0276240', 'cui_str': 'Infectious pustular vulvovaginitis (disorder)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0439849', 'cui_str': 'Relationships (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}]",,0.0905814,"CCP did not significantly prevent clinically significant IPV nor were there significant main effects of CCP on clinically significant IPV, frequency of IPV, or most relationship outcomes in the CACE or ITT analyses.","[{'ForeName': 'Richard E', 'Initials': 'RE', 'LastName': 'Heyman', 'Affiliation': 'New York University, New York, NY, USA. Richard.Heyman@NYU.edu.'}, {'ForeName': 'Amy M Smith', 'Initials': 'AMS', 'LastName': 'Slep', 'Affiliation': 'New York University, New York, NY, USA.'}, {'ForeName': 'Michael F', 'Initials': 'MF', 'LastName': 'Lorber', 'Affiliation': 'New York University, New York, NY, USA.'}, {'ForeName': 'Danielle M', 'Initials': 'DM', 'LastName': 'Mitnick', 'Affiliation': 'New York University, New York, NY, USA.'}, {'ForeName': 'Shu', 'Initials': 'S', 'LastName': 'Xu', 'Affiliation': 'New York University, New York, NY, USA.'}, {'ForeName': 'Katherine J W', 'Initials': 'KJW', 'LastName': 'Baucom', 'Affiliation': 'New York University, New York, NY, USA.'}, {'ForeName': 'W Kim', 'Initials': 'WK', 'LastName': 'Halford', 'Affiliation': 'University of Queensland, Brisbane, Australia.'}, {'ForeName': 'Phyllis Holditch', 'Initials': 'PH', 'LastName': 'Niolon', 'Affiliation': 'Centers for Disease Control and Prevention, Atlanta, GA, USA.'}]",Prevention science : the official journal of the Society for Prevention Research,['10.1007/s11121-018-0961-y'] 671,30536189,The Role of Culture of Origin on the Effectiveness of a Parents-Involved Intervention to Prevent Substance Use Among Latino Middle School Youth: Results of a Cluster Randomized Controlled Trial.,"The purpose of this study was to assess the combined effectiveness of a parenting intervention, Families Preparing the New Generation (FPNG), and a youth curriculum, keepin' it REAL (kiR), on substance use prevention for middle school students in a large urban metro area of the southwest USA. The study aimed to generate usable knowledge on what works in adolescent substance use prevention and how it works best-a combined parent and youth programming or parent-only programming. A total of 532 adolescents in the 7th grade from 19 participating middle schools were randomly assigned into three intervention conditions: parent-youth (PY), parent-only (PO), and comparison (C). This article focuses on the comparison between PY and PO in order to determine which intervention strategy works best to reduce adolescent substance use including alcohol, inhalant, cigarette, and marijuana uses. A generalized estimating equation (GEE) model examined the longitudinal data. The results for alcohol use show that PO yielded better results than PY and that PY outperformed C after 20 months. Further, PO showed a decreasing trajectory in any substance use over time since the implementation of the intervention. The effect sizes based on Cohen's h indicate small effects in any substance use and alcohol use for PO condition and smaller effects for the PY condition. These findings have implications for the design of future culturally specific parenting and youth prevention interventions with Latino families.",2019,The effect sizes based on Cohen's h indicate small effects in any substance use and alcohol use for PO condition and smaller effects for the PY condition.,"['Latino Middle School Youth', 'middle school students in a large urban metro area of the southwest USA', '532 adolescents in the 7th grade from 19 participating middle schools']","[""parenting intervention, Families Preparing the New Generation (FPNG), and a youth curriculum, keepin' it REAL (kiR"", 'intervention conditions: parent-youth (PY), parent-only (PO), and comparison (C', 'Parents-Involved Intervention']",[],"[{'cui': 'C0086528', 'cui_str': 'Latinos'}, {'cui': 'C0557797', 'cui_str': 'Middle school (environment)'}, {'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}]","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C4082130', 'cui_str': 'Prepared (qualifier value)'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0220815', 'cui_str': 'curriculum'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}]",[],532.0,0.0197484,The effect sizes based on Cohen's h indicate small effects in any substance use and alcohol use for PO condition and smaller effects for the PY condition.,"[{'ForeName': 'Flavio F', 'Initials': 'FF', 'LastName': 'Marsiglia', 'Affiliation': 'Global Center for Applied Health Research (GCAHR), Arizona State University, Phoenix, AZ, USA.'}, {'ForeName': 'Stephanie L', 'Initials': 'SL', 'LastName': 'Ayers', 'Affiliation': 'Global Center for Applied Health Research (GCAHR), Arizona State University, Phoenix, AZ, USA.'}, {'ForeName': 'SeungYong', 'Initials': 'S', 'LastName': 'Han', 'Affiliation': 'Global Center for Applied Health Research (GCAHR), Arizona State University, Phoenix, AZ, USA. shan32@asu.edu.'}, {'ForeName': 'Arianna', 'Initials': 'A', 'LastName': 'Weide', 'Affiliation': 'Global Center for Applied Health Research (GCAHR), Arizona State University, Phoenix, AZ, USA.'}]",Prevention science : the official journal of the Society for Prevention Research,['10.1007/s11121-018-0968-4'] 672,31669047,Effects of self-guided e-counseling on health behaviors and blood pressure: Results of a randomized trial.,"OBJECTIVE 1) Evaluate the efficacy of e-Counseling vs. Control to promote lifestyle behaviors at 4 and 12-month follow-ups, 2) examine whether these behaviors changes were associated with lower blood pressure (BP), and Framingham Risk Index (FRI) at 12-month. METHODS Hypertensive patients (n = 264) were randomized to the e-Counseling or the Control group. Primary trial outcome was BP and secondary outcomes included exercise and diet behaviors. This study presented the results of secondary outcomes. Linear mixed models evaluated treatment effects at 4 and 12-month. Treatment-by-sex exploratory analyses were conducted if no main treatment effect was observed. RESULTS Daily steps significantly improved in e-Counseling vs. Controls at 12-month. Urinary sodium at 12-month did not significantly differ between the groups, but treatment-by-sex analysis showed that e-Counseling females lowered urinary sodium relative to Controls at 12 months. Improvements in steps and dietary sodium were significantly associated with improvements in BP and FRI at 12-month. CONCLUSION This hypertension e-Counseling protocol can promote long-term lifestyle behavior changes. Adherence to the lifestyle behavior change was associated with BP and FRI reduction at 12-month. PRACTICE IMPLICATIONS The hypertension e-counseling protocol has the potential to improve hypertension care and intervention reach.",2020,"Urinary sodium at 12-month did not significantly differ between the groups, but treatment-by-sex analysis showed that e-Counseling females lowered urinary sodium relative to Controls at 12 months.",['Hypertensive patients (n\u202f=\u202f264'],"['self-guided e-counseling', 'e-Counseling vs. Control']","['BP and FRI reduction', 'BP and FRI', 'Urinary sodium', 'exercise and diet behaviors', 'health behaviors and blood pressure', 'urinary sodium relative', 'blood pressure (BP), and Framingham Risk Index (FRI']","[{'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C1510538', 'cui_str': 'E-Therapy'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C3541959', 'cui_str': 'Sodium supplement (substance)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0018687'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",,0.0188948,"Urinary sodium at 12-month did not significantly differ between the groups, but treatment-by-sex analysis showed that e-Counseling females lowered urinary sodium relative to Controls at 12 months.","[{'ForeName': 'Sam', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': 'University of Victoria, School of Exercise Science, Physical and Health Education, Victoria, British Columbia, Canada. Electronic address: samliu@uvic.ca.'}, {'ForeName': 'Rika', 'Initials': 'R', 'LastName': 'Tanaka', 'Affiliation': 'Peter Munk Cardiac Centre, University Health Network, Toronto, Ontario, Canada.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Barr', 'Affiliation': 'University of British Columbia, Department of Food, Nutrition & Health, British Columbia, Canada.'}, {'ForeName': 'Robert P', 'Initials': 'RP', 'LastName': 'Nolan', 'Affiliation': 'Peter Munk Cardiac Centre, University Health Network, Toronto, Ontario, Canada; University of Toronto, Faculty of Medicine, Toronto, Ontario, Canada.'}]",Patient education and counseling,['10.1016/j.pec.2019.10.007'] 673,31615840,Threat Memory Reminder Under Matrix Metalloproteinase 9 Inhibitor Doxycycline Globally Reduces Subsequent Memory Plasticity.,"Associative memory can be rendered malleable by a reminder. Blocking the ensuing reconsolidation process is suggested as a therapeutic target for unwanted aversive memories. Matrix metalloproteinase-9 (MMP-9) is required for structural synapse remodeling involved in memory consolidation. Inhibiting MMP-9 with doxycycline is suggested to attenuate human threat conditioning. Here, we investigated whether MMP-9 inhibition also interferes with threat memory reconsolidation. Male and female human participants ( N = 78) learned the association between two visual conditioned stimuli (CS + ) and a 50% chance of an unconditioned nociceptive stimulus (US), and between CS - and the absence of US. On day 7, one CS + was reminded without reinforcement 3.5 h after ingesting either 200 mg of doxycycline or placebo. On day 14, retention of CS memory was assessed under extinction by fear-potentiated startle. Contrary to our expectations, we observed a greater CS + /CS - difference in participants who were reminded under doxycycline compared with placebo. Participants who were reminded under placebo showed extinction learning during the retention test, which was not observed in the doxycycline group. There was no difference between the reminded and the nonreminded CS + in either group. In contrast, during relearning after the retention test, the CS + /CS - difference was more pronounced in the placebo group than in the doxycycline group. To summarize, a single dose of doxycycline before threat memory reminder appeared to have no specific impact on reconsolidation, but to globally impair extinction learning, and threat relearning, beyond drug clearance. SIGNIFICANCE STATEMENT Matrix metalloproteinase-9 inhibition appears to attenuate memory consolidation. It could also be a target for blocking reconsolidation. Here, we test this hypothesis in human threat conditioning. We find that doxycycline has no specific impact on a reminded cue, but confers a global reduction in extinction learning and threat learning beyond the clearance of the drug. This may point toward a more long-lasting impact of doxycycline treatment on memory plasticity.",2019,There was no difference between the reminded and the non-reminded CS+ in either group.,['male and female human participants'],"['doxycycline', 'visual conditioned stimuli (CS', 'placebo', 'Matrix metalloproteinase (MMP)-9', 'doxycycline, or placebo']","['memory plasticity', 'subsequent memory plasticity', 'extinction learning']","[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C0013090', 'cui_str': 'Doxycycline'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0234404', 'cui_str': 'Conditioned stimulus, function (observable entity)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0165519', 'cui_str': '92-kDa Type IV Collagenase'}]","[{'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0678558', 'cui_str': 'Plasticity'}, {'cui': 'C0015347', 'cui_str': 'Extinction (Psychology)'}]",78.0,0.274568,There was no difference between the reminded and the non-reminded CS+ in either group.,"[{'ForeName': 'Dominik R', 'Initials': 'DR', 'LastName': 'Bach', 'Affiliation': 'Computational Psychiatry Research, Department of Psychiatry, Psychotherapy and Psychosomatics, University of Zurich, 8032 Zurich, Switzerland, dominik.bach@uzh.ch.'}, {'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Näf', 'Affiliation': 'Computational Psychiatry Research, Department of Psychiatry, Psychotherapy and Psychosomatics, University of Zurich, 8032 Zurich, Switzerland.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Deutschmann', 'Affiliation': 'Computational Psychiatry Research, Department of Psychiatry, Psychotherapy and Psychosomatics, University of Zurich, 8032 Zurich, Switzerland.'}, {'ForeName': 'Shiva K', 'Initials': 'SK', 'LastName': 'Tyagarajan', 'Affiliation': 'Computational Psychiatry Research, Department of Psychiatry, Psychotherapy and Psychosomatics, University of Zurich, 8032 Zurich, Switzerland.'}, {'ForeName': 'Boris B', 'Initials': 'BB', 'LastName': 'Quednow', 'Affiliation': 'Neuroscience Centre Zurich, University of Zurich, 8057 Zurich, Switzerland.'}]",The Journal of neuroscience : the official journal of the Society for Neuroscience,['10.1523/JNEUROSCI.1285-19.2019'] 674,31794673,Exergaming Executive Functions: An Immersive Virtual Reality-Based Cognitive Training for Adults Aged 50 and Older.,"Prior research suggests that both exergaming and virtual reality (VR)-based training programs could improve executive functions in older adults. However, few studies investigated whether combining exergaming with VR would be more effective. This study seeks to (a) investigate whether playing exergames in an immersive virtual environment (IVE) would yield differential outcomes in selected executive functions, including inhibition, task switching, and working, and (b) examine the role of feeling of presence as a potential mediator between immersive exergaming and cognitive improvement in specific domains. Thirty-three participants over 50 years of age (mean age = 62) participated in a 4-week training program and were randomly assigned into an IVE and non-IVE to play an exergame (Fruit Ninja) for eight sessions within 4 weeks. The results revealed a significant effect of the IVE on the Stroop Test and Trail Making Test after the 4-week training. Furthermore, the impacts of the IVE exergaming on these two tasks were mediated by the feeling of presence. These findings suggested that the immersive experience of exergaming would elicit the feeling of presence, which later contributes to improved cognitive performances in inhibition and task switching. For the theoretical implications, this study extends previous research by showing that (a) feeling of presence could contribute to older adults' cognitive improvement, and (b) the impacts of immersive exergame training on executive functions vary across individual domains. Additionally, this study provides practical implications such that the design of exergames could emphasize the game features requiring mental simulation, which can serve as a novel strategy for preventing cognitive decline in midlife and old age.",2020,The results revealed a significant effect of the IVE on the Stroop Test and Trail Making Test after the 4-week training.,"['Exergaming Executive Functions', 'older adults', 'Thirty-three participants over 50 years of age (mean age\u2009=\u200962) participated in a', 'Adults Aged 50 and Older']","['immersive virtual environment (IVE', '4-week training program', 'exergaming and virtual reality (VR)-based training programs', 'immersive exergame training', 'IVE and non-IVE to play an exergame (Fruit Ninja', 'Immersive Virtual Reality-Based Cognitive Training']","['executive functions', 'Stroop Test and Trail Making Test']","[{'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0450358', 'cui_str': '33 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]","[{'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}]","[{'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C2718024', 'cui_str': 'Stroop Task'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}]",33.0,0.0153966,The results revealed a significant effect of the IVE on the Stroop Test and Trail Making Test after the 4-week training.,"[{'ForeName': 'Kuo-Ting', 'Initials': 'KT', 'LastName': 'Huang', 'Affiliation': 'Department of Journalism, Center for Emerging Media Design and Development, Ball State University, Muncie, Indiana.'}]","Cyberpsychology, behavior and social networking",['10.1089/cyber.2019.0269'] 675,30925120,Is WhatsApp Effective at Increasing the Return Rate of Blood Donors?,"Background : WhatsApp ® is one of the most used apps in Brazil. One of its main features is the potential to overcome geographical, cultural, and socioeconomic disparities. This app is increasingly being used as a tool for mobile health (m-health) interventions; however, with regard to blood donation, scientific studies are still lacking. The recruitment, return, and loyalty of blood donors are public health challenges, especially in developing countries. Objective : To verify the effectiveness of WhatsApp as a tool to increase the return rates of blood donors (first-time and loyal donors). Methods : The study was carried out with 548 individuals who voluntarily went to a private blood bank in the city of Maringá, south of Brazil, to donate blood. The participants were divided randomly into an intervention group (IG) and a control group (CG). Four messages were created following a strategy of persuasive communication and sent using an automatic system (Bulk System) to the list of participants in the IG after they had donated blood. Results : In contrast to our expectations, after the intervention, no significant difference in the return rates was observed between the IG and the CG. Loyal donors, regardless of whether they received the messages or not, returned in higher numbers compared with the first-time and sporadic donors. Conclusion : The intervention using WhatsApp was not effective at increasing the blood donors' return rates, suggesting that the motivations of blood donors are different from those of people who are undergoing self-care interventions. Furthermore, the difference in the blood donors' return rates suggests that specific interventions should be created according to the different stages of the donors' careers.",2020,"In contrast to our expectations, after the intervention, no significant difference in the return rates was observed between the IG and the CG.","['548 individuals who voluntarily went to a private blood bank in the city of Maringá, south of Brazil, to donate blood']",['intervention group (IG) and a control group (CG'],['return rates'],"[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C4521534', 'cui_str': 'US Military enlisted E1'}, {'cui': 'C0005770', 'cui_str': 'Blood Banks'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}, {'cui': 'C0005768'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",[],4.0,0.0240724,"In contrast to our expectations, after the intervention, no significant difference in the return rates was observed between the IG and the CG.","[{'ForeName': 'Tiago Franklin', 'Initials': 'TF', 'LastName': 'Rodrigues Lucena', 'Affiliation': 'Health Promotion Graduate Program, Unicesumar-Cesumar University Center, Maringá, Brazil.'}, {'ForeName': 'Lilian', 'Initials': 'L', 'LastName': 'Queiroz Negri', 'Affiliation': 'Unicesumar-Cesumar University Center, Maringá, Brazil.'}, {'ForeName': 'Daphine', 'Initials': 'D', 'LastName': 'Marcon', 'Affiliation': 'Unicesumar-Cesumar University Center, Maringá, Brazil.'}, {'ForeName': 'Mirian Ueda', 'Initials': 'MU', 'LastName': 'Yamaguchi', 'Affiliation': 'Health Promotion Graduate Program, Unicesumar-Cesumar University Center, Maringá, Brazil.'}]",Telemedicine journal and e-health : the official journal of the American Telemedicine Association,['10.1089/tmj.2019.0024'] 676,30930034,Evaluation of a plasticity-based cognitive training program in schizophrenia: Results from the eCaesar trial.,"OBJECTIVE Cognitive impairment in schizophrenia is a core feature of the disorder. Computerized cognitive training has shown promise in pilot studies. A 26-week randomized blinded placebo-controlled trial was conducted to investigate the effect of a novel computerized cognitive training program on cognitive and functional capacity outcomes. METHOD The study followed MATRICS guidelines for the evaluation of interventions designed to improve cognitive function in schizophrenia. Participants (N = 150) were randomized to experimental (computerized cognitive training in a game-like format) or active control (computer games) groups. Training was conducted in-clinic, with an intended training schedule of 5 days per week, 1 h per day, for 26 weeks. Co-primary outcome measures were the MATRICS Consensus Cognitive Battery (MCCB) composite score and the UCSD Performance-Based Skills Assessment (UPSA-2) total score, secondary outcome measures included the Cognitive Assessment Interview (CAI) and the Short-Form-12 Mental Composite Score (SF-12 MCS). Target engagement was assessed with task-learning based assessment. RESULTS At baseline, the groups were well matched. No significant effect of the experimental treatment was seen on the primary or secondary outcome measures compared to the active control. Review of the task learning/target engagement data suggested inadequate target engagement. CONCLUSIONS Results do not support a cognitive or functional capacity benefit from this implementation of a computerized cognitive training program in people with schizophrenia. In future trials, careful consideration is merited of the assessment of task learning/target engagement, the effects of making the cognitive training game-like on motivation, and the implicit effects of trial requirements on participant selection.",2019,No significant effect of the experimental treatment was seen on the primary or secondary outcome measures compared to the active control.,"['people with schizophrenia', 'schizophrenia', 'Participants (N\u202f=\u202f150']","['placebo', 'novel computerized cognitive training program', 'Computerized cognitive training', 'plasticity-based cognitive training program', 'computerized cognitive training program', 'experimental (computerized cognitive training in a game-like format) or active control (computer games']","['cognitive and functional capacity outcomes', 'Consensus Cognitive Battery (MCCB) composite score and the UCSD Performance-Based Skills Assessment (UPSA-2) total score, secondary outcome measures included the Cognitive Assessment Interview (CAI) and the Short-Form-12 Mental Composite Score (SF-12 MCS']","[{'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0678558', 'cui_str': 'Plasticity'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1301627', 'cui_str': 'Format'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0870328', 'cui_str': 'Computer Games'}]","[{'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0376298', 'cui_str': 'Consensus'}, {'cui': 'C0542351', 'cui_str': 'Battery (event)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}]",150.0,0.113283,No significant effect of the experimental treatment was seen on the primary or secondary outcome measures compared to the active control.,"[{'ForeName': 'Henry W', 'Initials': 'HW', 'LastName': 'Mahncke', 'Affiliation': 'Posit Science, United States of America. Electronic address: henry.mahncke@positscience.com.'}, {'ForeName': 'Sarah-Jane', 'Initials': 'SJ', 'LastName': 'Kim', 'Affiliation': 'Posit Science, United States of America.'}, {'ForeName': 'Annika', 'Initials': 'A', 'LastName': 'Rose', 'Affiliation': 'Posit Science, United States of America.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Stasio', 'Affiliation': 'Posit Science, United States of America.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Buckley', 'Affiliation': 'Virginia Commonwealth University, United States of America.'}, {'ForeName': 'Stanley', 'Initials': 'S', 'LastName': 'Caroff', 'Affiliation': 'Corporal Michael J. Crescenz VA Medical Center, The Perelman School of Medicine, University of Pennsylvania, United States of America.'}, {'ForeName': 'Erica', 'Initials': 'E', 'LastName': 'Duncan', 'Affiliation': 'Atlanta Veterans Affairs Medical Center, Emory University, United States of America.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Yasmin', 'Affiliation': 'Palo Alto Veterans Affairs Medical Center, United States of America.'}, {'ForeName': 'L Fredrik', 'Initials': 'LF', 'LastName': 'Jarskog', 'Affiliation': 'University of North Carolina at Chapel Hill, United States of America.'}, {'ForeName': 'J Steven', 'Initials': 'JS', 'LastName': 'Lamberti', 'Affiliation': 'University of Rochester, United States of America.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Nuechterlein', 'Affiliation': 'University of California, Los Angeles, United States of America.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Strassnig', 'Affiliation': 'University of Miami, United States of America.'}, {'ForeName': 'Dawn', 'Initials': 'D', 'LastName': 'Velligan', 'Affiliation': 'University of Texas Health Science Center in Austin, United States of America.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Ventura', 'Affiliation': 'University of California, Los Angeles, United States of America.'}, {'ForeName': 'Trina', 'Initials': 'T', 'LastName': 'Walker', 'Affiliation': 'Duke University, United States of America.'}, {'ForeName': 'T Scott', 'Initials': 'TS', 'LastName': 'Stroup', 'Affiliation': 'Columbia University, United States of America.'}, {'ForeName': 'Richard S E', 'Initials': 'RSE', 'LastName': 'Keefe', 'Affiliation': 'Duke University, United States of America.'}]",Schizophrenia research,['10.1016/j.schres.2019.03.006'] 677,31189674,Effect of real-time visual feedback device 'Quality Cardiopulmonary Resuscitation (QCPR) Classroom' with a metronome sound on layperson CPR training in Japan: a cluster randomized control trial.,"OBJECTIVES 'Quality Cardiopulmonary Resuscitation (QCPR) Classroom' was recently introduced to provide higher-quality Cardiopulmonary Resuscitation (CPR) training. This study aimed to examine whether novel QCPR Classroom training can lead to higher chest-compression quality than standard CPR training. DESIGN A cluster randomised controlled trial was conducted to compare standard CPR training (control) and QCPR Classroom (intervention). SETTING Layperson CPR training in Japan. PARTICIPANTS Six hundred forty-two people aged over 15 years were recruited from among CPR trainees. INTERVENTIONS CPR performance data were registered without feedback on instrumented Little Anne prototypes for 1 min pretraining and post-training. A large classroom was used in which QCPR Classroom participants could see their CPR performance on a big screen at the front; the control group only received instructor's subjective feedback. PRIMARY AND SECONDARY OUTCOME MEASURES The primary outcomes were compression depth (mm), rate (compressions per minute (cpm)), percentage of adequate depth (%) and recoil (%). Survey scores were a secondary outcome. The survey included participants' confidence regarding CPR parameters and ease of understanding instructor feedback. RESULTS In total, 259 and 238 people in the control and QCPR Classroom groups, respectively, were eligible for analysis. After training, the mean compression depth and rate were 56.1±9.8 mm and 119.2±7.3 cpm in the control group and 59.5±7.9 mm and 116.8±5.5 cpm in the QCPR Classroom group. The QCPR Classroom group showed significantly more adequate depth than the control group (p=0.001). There were 39.0% (95% CI 33.8 to 44.2; p<0.0001) and 20.0% improvements (95% CI 15.4 to 24.7; P<0.0001) in the QCPR Classroom and control groups, respectively. The difference in adequate recoil between pretraining and post-training was 2.7% (95% CI -1.7 to 7.1; pre 64.2±36.5% vs post 66.9%±34.6%; p=0.23) and 22.6% in the control and QCPR Classroom groups (95% CI 17.8 to 27.3; pre 64.8±37.5% vs post 87.4%±22.9%; p<0.0001), respectively. CONCLUSIONS QCPR Classroom helped students achieve high-quality CPR training, especially for proper compression depth and full recoil. For good educational achievement, a novel QCPR Classroom with a metronome sound is recommended.",2019,"There were 39.0% (95% CI 33.8 to 44.2; p<0.0001) and 20.0% improvements (95% CI 15.4 to 24.7; P<0.0001) in the QCPR Classroom and control groups, respectively.","['Six hundred forty-two people aged over 15 years were recruited from among CPR trainees', 'In total, 259 and 238 people in the control and QCPR Classroom groups, respectively, were eligible for analysis', 'Japan', 'Layperson CPR training in Japan']","['layperson CPR training', 'standard CPR training (control) and QCPR Classroom (intervention', 'Quality Cardiopulmonary Resuscitation (QCPR) Classroom', 'novel QCPR Classroom training', 'standard CPR training', ""real-time visual feedback device 'Quality Cardiopulmonary Resuscitation (QCPR) Classroom""]","['compression depth (mm), rate (compressions per minute (cpm)), percentage of adequate depth (%) and recoil ', 'mean compression depth and rate', 'CPR parameters and ease of understanding instructor feedback', 'adequate depth', 'adequate recoil', 'CPR performance']","[{'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C4319566', 'cui_str': 'Forty-two'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0007203', 'cui_str': 'Cardio-Pulmonary Resuscitation'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0007203', 'cui_str': 'Cardio-Pulmonary Resuscitation'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C2936181', 'cui_str': 'Visual Feedback'}, {'cui': 'C0220819', 'cui_str': 'devices'}]","[{'cui': 'C0332459', 'cui_str': 'Compression (morphologic abnormality)'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0702093', 'cui_str': '/min'}, {'cui': 'C0205411', 'cui_str': 'Adequate (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0007203', 'cui_str': 'Cardio-Pulmonary Resuscitation'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0556993', 'cui_str': 'Instructor (occupation)'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}]",642.0,0.0545141,"There were 39.0% (95% CI 33.8 to 44.2; p<0.0001) and 20.0% improvements (95% CI 15.4 to 24.7; P<0.0001) in the QCPR Classroom and control groups, respectively.","[{'ForeName': 'Shota', 'Initials': 'S', 'LastName': 'Tanaka', 'Affiliation': 'Research Institute of Disaster Management and EMS, Kokushikan University, Tama City, Japan.'}, {'ForeName': 'Kyoko', 'Initials': 'K', 'LastName': 'Tsukigase', 'Affiliation': 'Research Institute of Disaster Management and EMS, Kokushikan University, Tama City, Japan.'}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Hara', 'Affiliation': 'Graduate School of EMS System, Kokushikan University, Tama City, Japan.'}, {'ForeName': 'Ryo', 'Initials': 'R', 'LastName': 'Sagisaka', 'Affiliation': 'Graduate School of EMS System, Kokushikan University, Tama City, Japan.'}, {'ForeName': 'Helge', 'Initials': 'H', 'LastName': 'Myklebust', 'Affiliation': 'Laerdal Medical Cooperation, Stavanger, Norway.'}, {'ForeName': 'Tonje Soraas', 'Initials': 'TS', 'LastName': 'Birkenes', 'Affiliation': 'Laerdal Medical Cooperation, Stavanger, Norway.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Takahashi', 'Affiliation': 'Research Institute of Disaster Management and EMS, Kokushikan University, Tama City, Japan.'}, {'ForeName': 'Ayana', 'Initials': 'A', 'LastName': 'Iwata', 'Affiliation': 'Research Institute of Disaster Management and EMS, Kokushikan University, Tama City, Japan.'}, {'ForeName': 'Yutaro', 'Initials': 'Y', 'LastName': 'Kidokoro', 'Affiliation': 'Research Institute of Disaster Management and EMS, Kokushikan University, Tama City, Japan.'}, {'ForeName': 'Momoyo', 'Initials': 'M', 'LastName': 'Yamada', 'Affiliation': 'Research Institute of Disaster Management and EMS, Kokushikan University, Tama City, Japan.'}, {'ForeName': 'Hiroki', 'Initials': 'H', 'LastName': 'Ueta', 'Affiliation': 'Faculty of Emergency Medical Science, Meiji University of Integrative Medicine, Kyoto, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Takyu', 'Affiliation': 'Graduate School of EMS System, Kokushikan University, Tama City, Japan.'}, {'ForeName': 'Hideharu', 'Initials': 'H', 'LastName': 'Tanaka', 'Affiliation': 'Research Institute of Disaster Management and EMS, Kokushikan University, Tama City, Japan.'}]",BMJ open,['10.1136/bmjopen-2018-026140'] 678,30281086,Single-Session Mobile-Augmented Intervention in Serious Mental Illness: A Three-Arm Randomized Controlled Trial.,"Psychosocial interventions for serious mental illness are resource intensive and poorly accessible. Brief interventions (eg, single session) that are augmented by follow-on automated mobile health intervention may expand treatment access. This was a randomized single-blind controlled trial with 255 individuals diagnosed with schizophrenia or bipolar disorder. Participants were randomized to one of three conditions: CBT2go, which combined one individual session of cognitive behavioral therapy with automated thought challenging/adaptive behavior delivered through mobile devices; Self-Monitoring (SM), which combined single-session illness psychoeducation with self-monitoring of symptoms; and treatment-as-usual (TAU). Participants were assessed at baseline, 6 weeks (midpoint), 12 weeks (posttreatment), and 24 weeks (follow-up) with our primary outcome global psychopathology (Brief Psychiatric Rating Scale-expanded version [BPRS-24]), and secondary outcomes community functioning (Specific Level of Function; SLOF) and defeatist performance beliefs (DPBs). We also collected data on adverse events. Outcome analyses on the primary outcome, BPRS Total score, indicated a significant time (0-24 wk) by group interaction with significant but modest improvement comparing two active conditions (CBT2go and SM) relative to TAU. Effects of CBT2go were not different from SM. There was a significant time × group interaction with better SLOF scores in CBT2go across 24 weeks, but not in SM. There were no time-by-group effects on DPBs. DPBs decreased in the CBT2go condition but not in SM. These results indicated that single intervention augmented by mobile intervention was feasible and associated with small yet sustained effects on global psychopathology and, when inclusive of CBT, community function compared with usual care.",2019,"These results indicated that single intervention augmented by mobile intervention was feasible and associated with small yet sustained effects on global psychopathology and, when inclusive of CBT, community function compared with usual care.","['Serious Mental Illness', '255 individuals diagnosed with schizophrenia or bipolar disorder']","['Psychosocial interventions', 'Single-Session Mobile-Augmented Intervention', 'CBT2go, which combined one individual session of cognitive behavioral therapy with automated thought challenging/adaptive behavior delivered through mobile devices; Self-Monitoring (SM), which combined single-session illness psychoeducation with self-monitoring of symptoms; and treatment-as-usual (TAU', 'CBT2go']","['DPBs', 'active conditions (CBT2go and SM) relative to TAU', 'global psychopathology', 'global psychopathology (Brief Psychiatric Rating Scale-expanded version [BPRS-24]), and secondary outcomes community functioning (Specific Level of Function; SLOF) and defeatist performance beliefs (DPBs', 'SLOF scores', 'BPRS Total score']","[{'cui': 'C0004936', 'cui_str': 'Mental disorder (disorder)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C0005586', 'cui_str': 'Psychosis, Manic-Depressive'}]","[{'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0205554', 'cui_str': 'Automated (qualifier value)'}, {'cui': 'C4319827', 'cui_str': 'Thought'}, {'cui': 'C0085880', 'cui_str': 'Behavior, Adaptive'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0588436', 'cui_str': 'Self-monitoring (regime/therapy)'}, {'cui': 'C0221423', 'cui_str': 'Illness (finding)'}, {'cui': 'C0871175', 'cui_str': 'Psycho-education'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1720655', 'cui_str': 'Tau'}]","[{'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C3875154', 'cui_str': 'Relative to (attribute)'}, {'cui': 'C1720655', 'cui_str': 'Tau'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0033927', 'cui_str': 'Psychopathology'}, {'cui': 'C0029941', 'cui_str': 'Overall and Gorham Brief Psychiatric Rating Scale'}, {'cui': 'C0205229', 'cui_str': 'Expanding (qualifier value)'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]",255.0,0.282854,"These results indicated that single intervention augmented by mobile intervention was feasible and associated with small yet sustained effects on global psychopathology and, when inclusive of CBT, community function compared with usual care.","[{'ForeName': 'Colin A', 'Initials': 'CA', 'LastName': 'Depp', 'Affiliation': 'Department of Psychiatry, University of California, San Diego, San Diego, CA.'}, {'ForeName': 'Dimitri', 'Initials': 'D', 'LastName': 'Perivoliotis', 'Affiliation': 'Department of Psychiatry, University of California, San Diego, San Diego, CA.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Holden', 'Affiliation': 'Department of Psychiatry, University of California, San Diego, San Diego, CA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Dorr', 'Affiliation': 'Psychology Department, VA San Diego Healthcare System, San Diego, CA.'}, {'ForeName': 'Eric L', 'Initials': 'EL', 'LastName': 'Granholm', 'Affiliation': 'Department of Psychiatry, University of California, San Diego, San Diego, CA.'}]",Schizophrenia bulletin,['10.1093/schbul/sby135'] 679,31744701,Adding value to remote monitoring: Co-design of a health literacy intervention for older people with chronic disease delivered by telehealth - The telehealth literacy project.,"OBJECTIVE To co-design, test and evaluate a health literacy, chronic disease self-management and social support intervention for older people delivered by group videoconferencing into the home. METHOD The Telehealth Literacy Project (THLP) was a mixed methods, quasi-experimental, non-randomised trial nested within a telehealth remote monitoring study. An intervention group (n = 52) participated in five, weekly videoconference group meetings lasting for 1.5 h and a control group (n = 60) received remote monitoring only. Outcomes were measured using the nine-scale Health Literacy Questionnaire (HLQ) and two scales of the Health Education Impact Questionnaire (heiQ). Semi-structured interviews and focus group data were thematically analysed. RESULT At 3 month follow-up, univariate analysis identified small effects in the intervention group only, with improved health literacy behaviours (five HLQ scales) and self-management skills (two heiQ scales). ANOVA of HLQ scales indicated no significant differences between the two groups over time indicating a contributing effect of the remote monitoring project. Intervention participants reported improved perception of companionship, emotional and informational support. CONCLUSION The THLP delivered with telemonitoring indicates potential to improve social support and some health literacy factors in older people. PRACTICE IMPLICATIONS Patient education can be delivered by group videoconferencing.",2020,"At 3 month follow-up, univariate analysis identified small effects in the intervention group only, with improved health literacy behaviours (five HLQ scales) and self-management skills (two heiQ scales).","['older people', 'older people with chronic disease delivered by telehealth - The telehealth literacy project', 'older people delivered by group videoconferencing into the home']","['videoconference group meetings lasting for 1.5\u202fh and a control group (n\u202f=\u202f60) received remote monitoring only', 'THLP', 'Telehealth Literacy Project (THLP', 'health literacy intervention', 'social support intervention']","['HLQ scales', 'perception of companionship, emotional and informational support', 'health literacy behaviours (five HLQ scales) and self-management skills', 'nine-scale Health Literacy Questionnaire (HLQ) and two scales of the Health Education Impact Questionnaire (heiQ']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0008679', 'cui_str': 'Chronic Illness'}, {'cui': 'C1328956', 'cui_str': 'eHealth'}, {'cui': 'C0023864', 'cui_str': 'Literacy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1450048', 'cui_str': 'Videoconferencing'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}]","[{'cui': 'C1450049', 'cui_str': 'Videoconference'}, {'cui': 'C0018261', 'cui_str': 'Group Meetings'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205157', 'cui_str': 'Remote (qualifier value)'}, {'cui': 'C0076275', 'cui_str': 'orlistat'}, {'cui': 'C1328956', 'cui_str': 'eHealth'}, {'cui': 'C0023864', 'cui_str': 'Literacy'}, {'cui': 'C2362527', 'cui_str': 'Health Literacy'}, {'cui': 'C0037438'}]","[{'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C2362527', 'cui_str': 'Health Literacy'}, {'cui': 'C0222045'}, {'cui': 'C0086969', 'cui_str': 'Self-Management'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0018701'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}]",,0.0240448,"At 3 month follow-up, univariate analysis identified small effects in the intervention group only, with improved health literacy behaviours (five HLQ scales) and self-management skills (two heiQ scales).","[{'ForeName': 'Annie', 'Initials': 'A', 'LastName': 'Banbury', 'Affiliation': 'School of Nursing, Midwifery & Social Sciences, Central Queensland University, Rockhampton, Queensland, Australia; Centre for Online Health, The University of Queensland, Brisbane, Australia. Electronic address: a.banbury@cqu.edu.au.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Nancarrow', 'Affiliation': 'School of Health and Human Sciences, Southern Cross University, Lismore, New South Wales, Australia.'}, {'ForeName': 'Jared', 'Initials': 'J', 'LastName': 'Dart', 'Affiliation': 'Faculty of Health Sciences and Medicine, Bond University, Gold Coast, Queensland, Australia.'}, {'ForeName': 'Len', 'Initials': 'L', 'LastName': 'Gray', 'Affiliation': 'Centre for Health Services Research, The University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Sarity', 'Initials': 'S', 'LastName': 'Dodson', 'Affiliation': 'The Fred Hollows Foundation, Melbourne, Australia.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Osborne', 'Affiliation': 'Centre for Population Health Research, Deakin University, Melbourne, Australia.'}, {'ForeName': 'Lynne', 'Initials': 'L', 'LastName': 'Parkinson', 'Affiliation': 'School of Nursing, Midwifery & Social Sciences, Central Queensland University, Rockhampton, Queensland, Australia; Faculty of Health and Medicine, University of Newcastle, Australia.'}]",Patient education and counseling,['10.1016/j.pec.2019.10.005'] 680,30654120,Marked and rapid change of bone shape in acutely ACL injured knees - an exploratory analysis of the Kanon trial.,"BACKGROUND To investigate changes in knee 3D bone shape over the first 5 years after acute anterior cruciate ligament (ACL) injury in participants of the randomized controlled KANON-trial. METHODS Serial MR images over 5 years from 121 young (32 women, mean age 26.1 years) adults with an acute ACL tear in a previously un-injured knee were analyzed using statistical shape models for bone. A matched reference cohort of 176 individuals was selected from the Osteoarthritis Initiative (OAI). Primary endpoint was change in bone area of the medial femoral condyle; exploratory analyses compared results by treatment and examined other knee regions. Comparisons were made using repeated measures mixed model ANOVA with adjustment for age, sex and body mass index (BMI). RESULTS Mean medial femur bone area increased 3.2% (78.0 [95% CI 70.2 to 86.4] mm 2 ) over 5 years after ACL injury and most prominently in knees treated with ACL reconstruction (ACLR). A higher rate of increase occurred over the first 2 years compared to the latter 3-years (66.2 [59.3 to 73.2] vs 17.6 [12.2 to 23.0] mm 2 ) and was 6.7 times faster than in the reference cohort. The pattern and location of shape change in the extrapolated KANON data was very similar to that observed in another knee-osteoarthritis cohort. CONCLUSION 3D shape modelling after acute ACL injury revealed rapid bone shape changes, already evident at 3 months. The bone-change pattern after ACL injury demonstrated flattening and bone growth on the outer margins of the condyles similar to that reported in established knee osteoarthritis.",2019,"RESULTS Mean medial femur bone area increased 3.2% (78.0 [95% CI 70.2 to 86.4] mm 2 ) over 5 years after ACL injury and most prominently in knees treated with ACL reconstruction (ACLR).","['Serial MR images over 5 years from 121 young (32 women, mean age 26.1 years) adults with an acute ACL tear in a previously un-injured knee', 'acutely ACL injured knees ', 'acute anterior cruciate ligament (ACL) injury in participants of the randomized controlled KANON-trial', '176 individuals was selected from the Osteoarthritis Initiative (OAI']",[],"['rapid bone shape changes', 'bone shape', 'change in bone area of the medial femoral condyle; exploratory analyses', 'Mean medial femur bone area']","[{'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0409312', 'cui_str': 'Anterior Cruciate Ligament Tear'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C1456574', 'cui_str': 'Anterior Cruciate Ligament Injuries'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0029408', 'cui_str': 'Arthritis, Degenerative'}, {'cui': 'C0424093', 'cui_str': 'Initiative (observable entity)'}]",[],"[{'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0522512', 'cui_str': 'With shape (attribute)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0205098', 'cui_str': 'Medial (qualifier value)'}, {'cui': 'C0015811', 'cui_str': 'Femur'}, {'cui': 'C0524414', 'cui_str': 'Condyle'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",176.0,0.0290191,"RESULTS Mean medial femur bone area increased 3.2% (78.0 [95% CI 70.2 to 86.4] mm 2 ) over 5 years after ACL injury and most prominently in knees treated with ACL reconstruction (ACLR).","[{'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Bowes', 'Affiliation': 'Imorphics Ltd, Manchester, UK. Electronic address: mike@imorphics.com.'}, {'ForeName': 'L S', 'Initials': 'LS', 'LastName': 'Lohmander', 'Affiliation': 'Lund University, Faculty of Medicine, Department of Clinical Sciences Lund, Orthopedics, Lund, Sweden.'}, {'ForeName': 'C B H', 'Initials': 'CBH', 'LastName': 'Wolstenholme', 'Affiliation': 'Imorphics Ltd, Manchester, UK.'}, {'ForeName': 'G R', 'Initials': 'GR', 'LastName': 'Vincent', 'Affiliation': 'Imorphics Ltd, Manchester, UK.'}, {'ForeName': 'P G', 'Initials': 'PG', 'LastName': 'Conaghan', 'Affiliation': 'Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds and NIHR Leeds Biomedical Research Centre, Leeds, UK.'}, {'ForeName': 'R B', 'Initials': 'RB', 'LastName': 'Frobell', 'Affiliation': 'Lund University, Faculty of Medicine, Department of Clinical Sciences Lund, Orthopedics, Lund, Sweden.'}]",Osteoarthritis and cartilage,['10.1016/j.joca.2018.12.021'] 681,31577981,Neural correlates of early deliberate emotion regulation: Young children's responses to interpersonal scaffolding.,"Deliberate emotion regulation, the ability to willfully modulate emotional experiences, is shaped through interpersonal scaffolding and forecasts later functioning in multiple domains. However, nascent deliberate emotion regulation in early childhood is poorly understood due to a paucity of studies that simulate interpersonal scaffolding of this skill and measure its occurrence in multiple modalities. Our goal was to identify neural and behavioral components of early deliberate emotion regulation to identify patterns of competent and deficient responses. A novel probe was developed to assess deliberate emotion regulation in young children. Sixty children (age 4-6 years) were randomly assigned to deliberate emotion regulation or control conditions. Children completed a frustration task while lateral prefrontal cortex (LPFC) activation was recorded via functional near-infrared spectroscopy (fNIRS). Facial expressions were video recorded and children self-rated their emotions. Parents rated their child's temperamental emotion regulation. Deliberate emotion regulation interpersonal scaffolding predicted a significant increase in frustration-related LPFC activation not seen in controls. Better temperamental emotion regulation predicted larger LPFC activation increases post- scaffolding among children who engaged in deliberate emotion regulation interpersonal scaffolding. A capacity to increase LPFC activation in response to interpersonal scaffolding may be a crucial neural correlate of early deliberate emotion regulation.",2019,Deliberate emotion regulation interpersonal scaffolding predicted a significant increase in frustration-related LPFC activation not seen in controls.,"['young children', 'early deliberate emotion regulation', 'Sixty children (age 4-6\u202fyears', 'children who engaged in deliberate emotion regulation interpersonal scaffolding']",['deliberate emotion regulation or control conditions'],"['deliberate emotion regulation', 'frustration-related LPFC activation', 'frustration task while lateral prefrontal cortex (LPFC) activation', 'Facial expressions']","[{'cui': 'C0337547', 'cui_str': 'Younger child (person)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0013987', 'cui_str': 'Emotions'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married (finding)'}]","[{'cui': 'C0013987', 'cui_str': 'Emotions'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C0013987', 'cui_str': 'Emotions'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0016770', 'cui_str': 'Frustration'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0205093', 'cui_str': 'Lateral (qualifier value)'}, {'cui': 'C0162783', 'cui_str': 'Prefrontal Cortex'}, {'cui': 'C0015457', 'cui_str': 'Facial Expression'}]",60.0,0.0260829,Deliberate emotion regulation interpersonal scaffolding predicted a significant increase in frustration-related LPFC activation not seen in controls.,"[{'ForeName': 'Adam S', 'Initials': 'AS', 'LastName': 'Grabell', 'Affiliation': 'University of Massachusetts, Amherst, Department of Psychological and Brain Sciences, United States. Electronic address: agrabell@umass.edu.'}, {'ForeName': 'Theodore J', 'Initials': 'TJ', 'LastName': 'Huppert', 'Affiliation': 'University of Pittsburgh School of Engineering, Department of Bioengineering, United States.'}, {'ForeName': 'Frank A', 'Initials': 'FA', 'LastName': 'Fishburn', 'Affiliation': 'University of Pittsburgh School of Medicine, Department of Psychiatry, United States.'}, {'ForeName': 'Yanwei', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'University of Pittsburgh School of Medicine, Department of Psychiatry, United States; College of Preschool Education, Nanjing Xiaozhuang University, Nanjing, Jiangsu, China.'}, {'ForeName': 'Christina O', 'Initials': 'CO', 'LastName': 'Hlutkowsky', 'Affiliation': 'University of Pittsburgh School of Medicine, Department of Psychiatry, United States.'}, {'ForeName': 'Hannah M', 'Initials': 'HM', 'LastName': 'Jones', 'Affiliation': 'University of Pittsburgh School of Medicine, Department of Psychiatry, United States.'}, {'ForeName': 'Lauren S', 'Initials': 'LS', 'LastName': 'Wakschlag', 'Affiliation': 'Northwestern University, Department of Medical Social Sciences, Feinberg School of Medicine, Institute for Innovations in Developmental Sciences, United States.'}, {'ForeName': 'Susan B', 'Initials': 'SB', 'LastName': 'Perlman', 'Affiliation': 'Washington University, School of Medicine in St. Louis, Department of Psychiatry.'}]",Developmental cognitive neuroscience,['10.1016/j.dcn.2019.100708'] 682,32147881,Long-term efficacy and safety of topical glycopyrronium tosylate for the treatment of primary axillary hyperhidrosis: Post hoc pediatric subgroup analysis from a 44-week open-label extension study.,"BACKGROUND/OBJECTIVES Glycopyrronium tosylate (GT) cloth, 2.4% is a topical anticholinergic approved in the United States for primary axillary hyperhidrosis in patients ≥9 years. This post hoc analysis evaluated long-term response (efficacy and safety) in pediatric patients (≥9 to ≤16 years) to GT in the 44-week, open-label extension (NCT02553798) of two, phase 3, double-blind, vehicle-controlled, 4-week trials (NCT02530281, NCT02530294). METHODS In the double-blind trials, patients ≥9 years with primary axillary hyperhidrosis were randomized 2:1 to once-daily GT:vehicle. Those who completed the study could receive open-label GT for up to an additional 44 weeks. Safety assessments included treatment-emergent adverse events (TEAEs) and local skin reactions (LSRs). Descriptive efficacy assessments included gravimetrically measured sweat production, Hyperhidrosis Disease Severity Scale response (≥2-grade improvement), and Children's Dermatology Life Quality Index. RESULTS Of 43 pediatric patients completing either double-blind trial, 38 (88.4%) entered the open-label extension (age, years: 9 [n = 1], 12 [n = 2], 13 [n = 7], 14 and 15 [n = 9 each], 16 [n = 10]). The safety profile observed was similar to the double-blind trials. Most TEAEs (>95%) were mild/moderate, related to anticholinergic activity, and infrequently led to discontinuation (n = 1/38 [2.6%]). No pediatric patients experienced a serious TEAE. Most anticholinergic TEAEs did not require a dose modification and resolved within 7 days. Approximately, one-third of patients (n = 13/38 [34.2%]) had LSRs; most were mild/moderate in severity. Improvements in efficacy measures were maintained from the double-blind trials. CONCLUSIONS Long-term, once-daily GT for up to 48 weeks (4-week double-blind plus 44 week open label) provides a noninvasive, well-tolerated treatment option for pediatric patients with primary axillary hyperhidrosis.",2020,"Approximately, one-third of patients (n = 13/38 [34.2%]) had LSRs; most were mild/moderate in severity.","['pediatric patients (≥9 to ≤16\xa0years', 'pediatric patients with primary axillary hyperhidrosis', '43 pediatric patients completing either double-blind trial, 38 (88.4%) entered the open-label extension (age, years', 'patients ≥9\xa0years', 'primary axillary hyperhidrosis', 'patients ≥9\xa0years with primary axillary hyperhidrosis']","['4-week double-blind plus 44\xa0week open label', 'open-label GT', 'topical glycopyrronium tosylate']","['serious TEAE', ""sweat production, Hyperhidrosis Disease Severity Scale response (≥2-grade improvement), and Children's Dermatology Life Quality Index"", 'Safety assessments included treatment-emergent adverse events (TEAEs) and local skin reactions (LSRs', 'safety profile', 'LSRs', 'long-term response (efficacy and safety', 'efficacy measures', 'anticholinergic activity']","[{'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0004454', 'cui_str': 'Axilla'}, {'cui': 'C0020458', 'cui_str': 'Hyperhidrosis'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C4719440', 'cui_str': 'glycopyrronium tosylate'}]","[{'cui': 'C0038990', 'cui_str': 'Sweating'}, {'cui': 'C0033268'}, {'cui': 'C0020458', 'cui_str': 'Hyperhidrosis'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0222045'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0451112', 'cui_str': 'Dermatology life quality index (assessment scale)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0221743', 'cui_str': 'Skin reaction (observable entity)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0242896', 'cui_str': 'Anticholinergic Agents'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}]",43.0,0.401597,"Approximately, one-third of patients (n = 13/38 [34.2%]) had LSRs; most were mild/moderate in severity.","[{'ForeName': 'Adelaide A', 'Initials': 'AA', 'LastName': 'Hebert', 'Affiliation': 'UTHealth McGovern Medical School, Houston, Texas, United States.'}, {'ForeName': 'Dee Anna', 'Initials': 'DA', 'LastName': 'Glaser', 'Affiliation': 'Saint Louis University, St. Louis, Missouri, United States.'}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Green', 'Affiliation': 'George Washington University School of Medicine, Washington, District of Columbia, United States.'}, {'ForeName': 'Cheryl', 'Initials': 'C', 'LastName': 'Hull', 'Affiliation': 'Northwest Arkansas Clinical Trials Center, PLLC, Rogers, Arkansas.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Cather', 'Affiliation': 'Modern Research Associates, PLLC, Dallas, Texas, United States.'}, {'ForeName': 'Janice', 'Initials': 'J', 'LastName': 'Drew', 'Affiliation': 'Dermira, Inc., Menlo Park, California, United States.'}, {'ForeName': 'Ramanan', 'Initials': 'R', 'LastName': 'Gopalan', 'Affiliation': 'Dermira, Inc., Menlo Park, California, United States.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Pariser', 'Affiliation': 'Eastern Virginia Medical School, Virginia Clinical Research, Inc., Norfolk, Virginia, United States.'}]",Pediatric dermatology,['10.1111/pde.14135'] 683,32147925,Evaluation of pharmacokinetics and acute anti-inflammatory potential of two oral cannabidiol preparations in healthy adults.,"Cannabidiol (CBD) is a dietary supplement with numerous purported health benefits and an expanding commercial market. Commercially available CBD preparations range from tinctures, oils, and powders, to foods and beverages. Despite widespread use, information regarding bioavailability of these formulations is limited. The purpose of this study was to test the bioavailability of two oral formulations of CBD in humans and explore their potential acute anti-inflammatory activity. We conducted a pilot randomized, parallel arm, double-blind study in 10 healthy adults to determine differences in pharmacokinetics of commercially available water and lipid-soluble CBD powders. Participants consumed a single 30 mg dose, which is within the range of typical commercial supplement doses, and blood samples were collected over 6 hr and analyzed for CBD concentrations. Peripheral blood mononuclear cells (PBMCs) were collected at baseline and T = 90 min, cultured and stimulated with bacterial lipopolysaccharide (LPS) to induce an inflammatory response. Cell supernatants were assayed for IL-10 and TNF, markers of inflammation, using enzyme-linked immunosorbent assays. The water-soluble powder had C max = 2.82 ng/ml, T max = 90 min, and was approximately ×4.5 more bioavailable than the lipid-soluble form. TNF was decreased in LPS-stimulated PBMCs collected 90 min after CBD exposure relative to cells collected at baseline. This study provides pilot data for designing and powering future studies to establish the anti-inflammatory potential and bioavailability of a larger variety of commercial CBD products consumed by humans.",2020,TNF was decreased in LPS-stimulated PBMCs collected 90 min after CBD exposure relative to cells collected at baseline.,"['10 healthy adults', 'healthy adults']","['CBD', 'Cannabidiol (CBD']","['Peripheral blood mononuclear cells (PBMCs', 'TNF']","[{'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}]","[{'cui': 'C0006863', 'cui_str': '1,3-Benzenediol, 2-(3-methyl-6-(1-methylethenyl)-2-cyclohexen-1-yl)-5-pentyl-, (1R-trans)-'}]","[{'cui': 'C1321301', 'cui_str': 'Peripheral blood mononuclear cell'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}]",10.0,0.129903,TNF was decreased in LPS-stimulated PBMCs collected 90 min after CBD exposure relative to cells collected at baseline.,"[{'ForeName': 'Jack M', 'Initials': 'JM', 'LastName': 'Hobbs', 'Affiliation': 'Food and Nutrition Clinical Research Laboratory, Department of Food Science and Human Nutrition, Colorado State University, Fort Collins, Colorado.'}, {'ForeName': 'Allegra R', 'Initials': 'AR', 'LastName': 'Vazquez', 'Affiliation': 'Food and Nutrition Clinical Research Laboratory, Department of Food Science and Human Nutrition, Colorado State University, Fort Collins, Colorado.'}, {'ForeName': 'Nicholas D', 'Initials': 'ND', 'LastName': 'Remijan', 'Affiliation': 'Department of Horticulture and Landscape Architecture, Colorado State University, Fort Collins, Colorado.'}, {'ForeName': 'Roxanne E', 'Initials': 'RE', 'LastName': 'Trotter', 'Affiliation': 'Food and Nutrition Clinical Research Laboratory, Department of Food Science and Human Nutrition, Colorado State University, Fort Collins, Colorado.'}, {'ForeName': 'Thomas V', 'Initials': 'TV', 'LastName': 'McMillan', 'Affiliation': 'Food and Nutrition Clinical Research Laboratory, Department of Food Science and Human Nutrition, Colorado State University, Fort Collins, Colorado.'}, {'ForeName': 'Kimberly E', 'Initials': 'KE', 'LastName': 'Freedman', 'Affiliation': 'Food and Nutrition Clinical Research Laboratory, Department of Food Science and Human Nutrition, Colorado State University, Fort Collins, Colorado.'}, {'ForeName': 'Yuren', 'Initials': 'Y', 'LastName': 'Wei', 'Affiliation': 'Food and Nutrition Clinical Research Laboratory, Department of Food Science and Human Nutrition, Colorado State University, Fort Collins, Colorado.'}, {'ForeName': 'Keith A', 'Initials': 'KA', 'LastName': 'Woelfel', 'Affiliation': 'Caliper Foods, Commerce City, Colorado.'}, {'ForeName': 'Olivia R', 'Initials': 'OR', 'LastName': 'Arnold', 'Affiliation': 'Department of Environmental and Radiological Health Sciences, Colorado State University, Fort Collins, Colorado.'}, {'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'Wolfe', 'Affiliation': 'Proteomics and Metabolomics Facility, Office of the Vice President, Colorado State University, Fort Collins, Colorado.'}, {'ForeName': 'Sarah A', 'Initials': 'SA', 'LastName': 'Johnson', 'Affiliation': 'Food and Nutrition Clinical Research Laboratory, Department of Food Science and Human Nutrition, Colorado State University, Fort Collins, Colorado.'}, {'ForeName': 'Tiffany L', 'Initials': 'TL', 'LastName': 'Weir', 'Affiliation': 'Food and Nutrition Clinical Research Laboratory, Department of Food Science and Human Nutrition, Colorado State University, Fort Collins, Colorado.'}]",Phytotherapy research : PTR,['10.1002/ptr.6651'] 684,31517597,FRESH: Long-Term Outcomes of a Randomized Trial to Reduce Radon and Tobacco Smoke in the Home.,"INTRODUCTION Tobacco smoke and radon are the leading causes of lung cancer. The FRESH intervention was a randomized controlled trial of 515 homeowners to promote stage of action to reduce radon and air nicotine levels. METHODS We studied 515 participants, 257 in a treatment group and 258 in a control group. Treatment participants received free radon and air nicotine test kits, report back, and telephone support, and those participants whose homes had high radon levels received a voucher for $600 toward mitigation. Both groups were asked to retest 15 months post intervention. We examined differences in stage of action to test for and mitigate radon and adopt a smoke-free-home policy and in observed radon and air nicotine values by study group over time. RESULTS Homeowners in the treatment group scored higher on stage of action to test for radon and air nicotine and to mitigate for radon during follow-up than those in the control group at 3 months and 9 months, but the effect of the intervention diminished after 9 months. We saw no difference between groups or over time in observed radon or air nicotine values. Of homeowners in the treatment group with high radon levels at baseline, 17% mitigated, and 80% of them used the voucher we provided. CONCLUSION The null finding of no significant change in observed radon or air nicotine values from baseline to 15 months may reflect the low proportion of radon mitigation systems installed and the decline in stage of action to adopt a smoke-free home policy. Including a booster session at 9 months post intervention may improve the remediation rate.",2019,"RESULTS Homeowners in the treatment group scored higher on stage of action to test for radon and air nicotine and to mitigate for radon during follow-up than those in the control group at 3 months and 9 months, but the effect of the intervention diminished after 9 months.","['515 participants, 257 in a treatment group and 258 in a control group']","['free radon and air nicotine test kits, report back, and telephone support', 'FRESH', 'FRESH intervention']","['remediation rate', 'observed radon or air nicotine values', 'stage of action to test for radon and air nicotine and to mitigate for radon']","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0034629', 'cui_str': 'Radon'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C1272835', 'cui_str': 'Test kit'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0443224', 'cui_str': 'Fresh (qualifier value)'}]","[{'cui': 'C3875135', 'cui_str': 'Observes (attribute)'}, {'cui': 'C0034629', 'cui_str': 'Radon'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0441472', 'cui_str': 'Action (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}]",515.0,0.0330416,"RESULTS Homeowners in the treatment group scored higher on stage of action to test for radon and air nicotine and to mitigate for radon during follow-up than those in the control group at 3 months and 9 months, but the effect of the intervention diminished after 9 months.","[{'ForeName': 'Ellen J', 'Initials': 'EJ', 'LastName': 'Hahn', 'Affiliation': 'University of Kentucky Colleges of Nursing and Public Health, 2265 Harrodsburg Road, Lexington, KY 40504. Email: ejhahn00@email.uky.edu.'}, {'ForeName': 'Amanda T', 'Initials': 'AT', 'LastName': 'Wiggins', 'Affiliation': 'University of Kentucky College of Nursing, Lexington, Kentucky.'}, {'ForeName': 'Kathy', 'Initials': 'K', 'LastName': 'Rademacher', 'Affiliation': 'University of Kentucky College of Nursing, Lexington, Kentucky.'}, {'ForeName': 'Karen M', 'Initials': 'KM', 'LastName': 'Butler', 'Affiliation': 'University of Kentucky College of Nursing, Lexington, Kentucky.'}, {'ForeName': 'Luz', 'Initials': 'L', 'LastName': 'Huntington-Moskos', 'Affiliation': 'University of Kentucky College of Nursing, Lexington, Kentucky.'}, {'ForeName': 'Mary Kay', 'Initials': 'MK', 'LastName': 'Rayens', 'Affiliation': 'University of Kentucky Colleges of Nursing and Public Health, Lexington, Kentucky.'}]",Preventing chronic disease,['10.5888/pcd16.180634'] 685,31263284,Supplementation with Akkermansia muciniphila in overweight and obese human volunteers: a proof-of-concept exploratory study.,"Metabolic syndrome is characterized by a constellation of comorbidities that predispose individuals to an increased risk of developing cardiovascular pathologies as well as type 2 diabetes mellitus 1 . The gut microbiota is a new key contributor involved in the onset of obesity-related disorders 2 . In humans, studies have provided evidence for a negative correlation between Akkermansia muciniphila abundance and overweight, obesity, untreated type 2 diabetes mellitus or hypertension 3-8 . Since the administration of A. muciniphila has never been investigated in humans, we conducted a randomized, double-blind, placebo-controlled pilot study in overweight/obese insulin-resistant volunteers; 40 were enrolled and 32 completed the trial. The primary end points were safety, tolerability and metabolic parameters (that is, insulin resistance, circulating lipids, visceral adiposity and body mass). Secondary outcomes were gut barrier function (that is, plasma lipopolysaccharides) and gut microbiota composition. In this single-center study, we demonstrated that daily oral supplementation of 10 10 A. muciniphila bacteria either live or pasteurized for three months was safe and well tolerated. Compared to placebo, pasteurized A. muciniphila improved insulin sensitivity (+28.62 ± 7.02%, P = 0.002), and reduced insulinemia (-34.08 ± 7.12%, P = 0.006) and plasma total cholesterol (-8.68 ± 2.38%, P = 0.02). Pasteurized A. muciniphila supplementation slightly decreased body weight (-2.27 ± 0.92 kg, P = 0.091) compared to the placebo group, and fat mass (-1.37 ± 0.82 kg, P = 0.092) and hip circumference (-2.63 ± 1.14 cm, P = 0.091) compared to baseline. After three months of supplementation, A. muciniphila reduced the levels of the relevant blood markers for liver dysfunction and inflammation while the overall gut microbiome structure was unaffected. In conclusion, this proof-of-concept study (clinical trial no. NCT02637115 ) shows that the intervention was safe and well tolerated and that supplementation with A. muciniphila improves several metabolic parameters.",2019,"Compared to placebo, pasteurized A. muciniphila improved insulin sensitivity (+28.62 ± 7.02%, P = 0.002), and reduced insulinemia (-34.08 ± 7.12%, P = 0.006) and plasma total cholesterol (-8.68 ± 2.38%, P = 0.02).","['overweight/obese insulin-resistant volunteers; 40 were enrolled and 32 completed the trial', 'overweight and obese human volunteers']","['placebo', 'Akkermansia muciniphila']","['safe and well tolerated', 'insulin sensitivity', 'reduced insulinemia', 'several metabolic parameters', 'body weight', 'fat mass', 'gut barrier function (that is, plasma lipopolysaccharides) and gut microbiota composition', 'hip circumference', 'safety, tolerability and metabolic parameters (that is, insulin resistance, circulating lipids, visceral adiposity and body mass', 'levels of the relevant blood markers for liver dysfunction and inflammation', 'plasma total cholesterol']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0332325', 'cui_str': 'Resistant (qualifier value)'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0020155', 'cui_str': 'Human Volunteers'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1490590', 'cui_str': 'Akkermansia muciniphila'}]","[{'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0023810', 'cui_str': 'Lipoglycans'}, {'cui': 'C4018878', 'cui_str': 'Gastrointestinal Microbial Community'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0562350', 'cui_str': 'Hip circumference (observable entity)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0442045', 'cui_str': 'Visceral (qualifier value)'}, {'cui': 'C1563743', 'cui_str': 'Adiposis'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0005768'}, {'cui': 'C0086565', 'cui_str': 'Liver Dysfunction'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}]",40.0,0.293433,"Compared to placebo, pasteurized A. muciniphila improved insulin sensitivity (+28.62 ± 7.02%, P = 0.002), and reduced insulinemia (-34.08 ± 7.12%, P = 0.006) and plasma total cholesterol (-8.68 ± 2.38%, P = 0.02).","[{'ForeName': 'Clara', 'Initials': 'C', 'LastName': 'Depommier', 'Affiliation': 'Metabolism and Nutrition Research Group, Louvain Drug Research Institute, WELBIO, Walloon Excellence in Life Sciences and BIOtechnology, UCLouvain, Université catholique de Louvain, Brussels, Belgium.'}, {'ForeName': 'Amandine', 'Initials': 'A', 'LastName': 'Everard', 'Affiliation': 'Metabolism and Nutrition Research Group, Louvain Drug Research Institute, WELBIO, Walloon Excellence in Life Sciences and BIOtechnology, UCLouvain, Université catholique de Louvain, Brussels, Belgium.'}, {'ForeName': 'Céline', 'Initials': 'C', 'LastName': 'Druart', 'Affiliation': 'Metabolism and Nutrition Research Group, Louvain Drug Research Institute, WELBIO, Walloon Excellence in Life Sciences and BIOtechnology, UCLouvain, Université catholique de Louvain, Brussels, Belgium.'}, {'ForeName': 'Hubert', 'Initials': 'H', 'LastName': 'Plovier', 'Affiliation': 'Metabolism and Nutrition Research Group, Louvain Drug Research Institute, WELBIO, Walloon Excellence in Life Sciences and BIOtechnology, UCLouvain, Université catholique de Louvain, Brussels, Belgium.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Van Hul', 'Affiliation': 'Metabolism and Nutrition Research Group, Louvain Drug Research Institute, WELBIO, Walloon Excellence in Life Sciences and BIOtechnology, UCLouvain, Université catholique de Louvain, Brussels, Belgium.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Vieira-Silva', 'Affiliation': 'Laboratory of Molecular Bacteriology-Department of Microbiology and Immunology, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Gwen', 'Initials': 'G', 'LastName': 'Falony', 'Affiliation': 'Laboratory of Molecular Bacteriology-Department of Microbiology and Immunology, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Jeroen', 'Initials': 'J', 'LastName': 'Raes', 'Affiliation': 'Laboratory of Molecular Bacteriology-Department of Microbiology and Immunology, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Dominique', 'Initials': 'D', 'LastName': 'Maiter', 'Affiliation': 'Pôle EDIN, Institut de Recherches Expérimentales et Cliniques, UCLouvain, Université catholique de Louvain, Louvain-la-Neuve, Belgium.'}, {'ForeName': 'Nathalie M', 'Initials': 'NM', 'LastName': 'Delzenne', 'Affiliation': 'Metabolism and Nutrition Research Group, Louvain Drug Research Institute, UCLouvain, Université catholique de Louvain, Brussels, Belgium.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'de Barsy', 'Affiliation': 'Pôle EDIN, Institut de Recherches Expérimentales et Cliniques, UCLouvain, Université catholique de Louvain, Louvain-la-Neuve, Belgium.'}, {'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'Loumaye', 'Affiliation': 'Pôle EDIN, Institut de Recherches Expérimentales et Cliniques, UCLouvain, Université catholique de Louvain, Louvain-la-Neuve, Belgium.'}, {'ForeName': 'Michel P', 'Initials': 'MP', 'LastName': 'Hermans', 'Affiliation': 'Pôle EDIN, Institut de Recherches Expérimentales et Cliniques, UCLouvain, Université catholique de Louvain, Louvain-la-Neuve, Belgium.'}, {'ForeName': 'Jean-Paul', 'Initials': 'JP', 'LastName': 'Thissen', 'Affiliation': 'Pôle EDIN, Institut de Recherches Expérimentales et Cliniques, UCLouvain, Université catholique de Louvain, Louvain-la-Neuve, Belgium.'}, {'ForeName': 'Willem M', 'Initials': 'WM', 'LastName': 'de Vos', 'Affiliation': 'Laboratory of Microbiology, Wageningen University, Wageningen, the Netherlands.'}, {'ForeName': 'Patrice D', 'Initials': 'PD', 'LastName': 'Cani', 'Affiliation': 'Metabolism and Nutrition Research Group, Louvain Drug Research Institute, WELBIO, Walloon Excellence in Life Sciences and BIOtechnology, UCLouvain, Université catholique de Louvain, Brussels, Belgium. Patrice.cani@uclouvain.be.'}]",Nature medicine,['10.1038/s41591-019-0495-2'] 686,31606826,"Systematic screening using FRAX ® leads to increased use of, and adherence to, anti-osteoporosis medications: an analysis of the UK SCOOP trial.","In the large community-based SCOOP trial, systematic fracture risk screening using FRAX ® led to greater use of AOM and greater adherence, in women at high fracture risk, compared with usual care. INTRODUCTION In the SCreening of Older wOmen for Prevention of fracture (SCOOP) trial, we investigated the effect of the screening intervention on subsequent long-term self-reported adherence to anti-osteoporosis medications (AOM). METHODS SCOOP was a primary care-based UK multicentre trial of screening for fracture risk. A total of 12,483 women (70-85 years) were randomised to either usual NHS care, or assessment using the FRAX ® tool ± dual-energy X-ray absorptiometry (DXA), with medication recommended for those found to be at high risk of hip fracture. Self-reported AOM use was obtained by postal questionnaires at 6, 12, 24, 36, 48 and 60 months. Analysis was limited to those who initiated AOM during follow-up. Logistic regression was used to explore baseline determinants of adherence (good ≥ 80%; poor < 80%). RESULTS The mean (SD) age of participants was 75.6 (4.2) years, with 6233 randomised to screening and 6250 to the control group. Of those participants identified at high fracture risk in the screening group, 38.2% of those on treatment at 6 months were still treated at 60 months, whereas the corresponding figure for the control group was 21.6%. Older age was associated with poorer adherence (OR per year increase in age 0.96 [95% CI 0.93, 0.99], p = 0.01), whereas history of parental hip fracture was associated with greater rate adherence (OR 1.67 [95% CI 1.23, 2.26], p < 0.01). CONCLUSIONS Systematic fracture risk screening using FRAX ® leads to greater use of AOM and greater adherence, in women at high fracture risk, compared with usual care.",2020,Older age was associated with poorer adherence (OR per year increase in age 0.96,"['12,483 women (70-85\xa0years', 'SCOOP was a primary care-based UK multicentre trial of screening for fracture risk', 'Older wOmen for Prevention of fracture (SCOOP) trial', 'The mean (SD) age of participants was 75.6 (4.2) years, with 6233 randomised to screening and 6250 to the control group']","['usual NHS care, or assessment using the FRAX ® tool ± dual-energy X-ray absorptiometry (DXA']","['rate adherence', 'fracture risk']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0183177', 'cui_str': 'Scoop'}, {'cui': 'C1292718', 'cui_str': 'Is a'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0206012', 'cui_str': 'Multicenter Trials'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517758', 'cui_str': 'Four point two'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0336791', 'cui_str': 'Tool, device (physical object)'}, {'cui': 'C1510486', 'cui_str': 'Dual X-Ray Absorptiometry'}]","[{'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",,0.0582528,Older age was associated with poorer adherence (OR per year increase in age 0.96,"[{'ForeName': 'C M', 'Initials': 'CM', 'LastName': 'Parsons', 'Affiliation': 'MRC Lifecourse Epidemiology Unit, University of Southampton, Southampton, SO16 6YD, UK.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Harvey', 'Affiliation': 'MRC Lifecourse Epidemiology Unit, University of Southampton, Southampton, SO16 6YD, UK.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Shepstone', 'Affiliation': 'University of East Anglia, Norwich, UK.'}, {'ForeName': 'J A', 'Initials': 'JA', 'LastName': 'Kanis', 'Affiliation': 'Centre for Metabolic Bone Diseases, University of Sheffield, Sheffield, UK.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Lenaghan', 'Affiliation': 'University of East Anglia, Norwich, UK.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Clarke', 'Affiliation': 'Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Fordham', 'Affiliation': 'University of East Anglia, Norwich, UK.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Gittoes', 'Affiliation': 'Centre for Endocrinology, Diabetes and Metabolism, Queen Elizabeth Hospital, Birmingham, UK.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Harvey', 'Affiliation': 'University of East Anglia, Norwich, UK.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Holland', 'Affiliation': 'University of East Anglia, Norwich, UK.'}, {'ForeName': 'N M', 'Initials': 'NM', 'LastName': 'Redmond', 'Affiliation': 'Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Howe', 'Affiliation': 'University of East Anglia, Norwich, UK.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Marshall', 'Affiliation': 'University of East Anglia, Norwich, UK.'}, {'ForeName': 'T J', 'Initials': 'TJ', 'LastName': 'Peters', 'Affiliation': 'Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Torgerson', 'Affiliation': 'University of York, York, UK.'}, {'ForeName': 'T W', 'Initials': 'TW', 'LastName': ""O'Neill"", 'Affiliation': 'Arthritis Research UK Centre for Epidemiology, Faculty of Biology, Medicine and Health, The University of Manchester, Manchester, UK.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'McCloskey', 'Affiliation': 'Centre for Metabolic Bone Diseases, University of Sheffield, Sheffield, UK.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Cooper', 'Affiliation': 'MRC Lifecourse Epidemiology Unit, University of Southampton, Southampton, SO16 6YD, UK. cc@mrc.soton.ac.uk.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA,['10.1007/s00198-019-05142-z'] 687,31688579,"Effects of perimenopausal transdermal estradiol on self-reported sleep, independent of its effect on vasomotor symptom bother and depressive symptoms.","OBJECTIVE The aim of this study was to determine the efficacy of transdermal estradiol (E2) plus intermittent progesterone (EPT) for improving self-reported sleep in perimenopausal women, after controlling for vasomotor symptoms (VMS) bother and depressive symptoms. METHODS Using a double-blind, placebo-controlled design, 172 healthy women meeting STRAW+10 criteria for being in the menopausal transition or early postmenopause were randomized to 12 months of transdermal E2 (0.1 mg/d) + 200 mg progesterone (12 d every 3 mo) or placebo. Using standard questionnaires, self-reported sleep, depression, and VMS bother were obtained at baseline and bimonthly postrandomization. RESULTS Controlling for baseline levels, EPT (vs placebo) led to reductions in minutes to fall asleep (estimate = -0.12, P = 0.002) and number of awakenings (estimate = -0.24, P = 0.04) over the 12 months. Controlling for changes in VMS bother and depressive symptoms, EPT still predicted reductions in minutes to fall asleep (estimate = -0.28, P = 0.02) and number of awakenings (estimate = -0.11, P = 0.02) over the 12 months. CONCLUSIONS We extend existing research by demonstrating that hormone therapy (HT) in subjective sleep cannot be fully explained by improvements in VMS bother or depressive symptoms. Research to examine the mechanism (s) underlying HT's effects on sleep would have public health significance for perimenopausal women and also advance our general understanding of the pathophysiology of impaired sleep.",2019,"RESULTS Controlling for baseline levels, EPT (vs placebo) led to reductions in minutes to fall asleep (estimate =","['perimenopausal women', 'perimenopausal women, after controlling for vasomotor symptoms (VMS) bother and depressive symptoms', '172 healthy women meeting STRAW+10 criteria for being in the menopausal transition or early postmenopause']","['perimenopausal transdermal estradiol', 'placebo', 'transdermal estradiol (E2) plus intermittent progesterone (EPT', 'EPT (vs placebo', 'hormone therapy (HT', 'transdermal E2 (0.1\u200amg/d) + 200\u200amg progesterone']","['standard questionnaires, self-reported sleep, depression, and VMS bother', 'vasomotor symptom bother and depressive symptoms', 'VMS bother or depressive symptoms', 'number of awakenings']","[{'cui': 'C3839366', 'cui_str': 'Perimenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C4517601', 'cui_str': '172 (qualifier value)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0025320', 'cui_str': 'Change of Life, Female'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0206159', 'cui_str': 'Post-menopausal Period'}]","[{'cui': 'C3839366', 'cui_str': 'Perimenopausal state (finding)'}, {'cui': 'C4521342', 'cui_str': 'Transdermal (intended site)'}, {'cui': 'C1700235', 'cui_str': '(11BAPOP2) estradiol'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0205267', 'cui_str': 'Intermittent (qualifier value)'}, {'cui': 'C0373705', 'cui_str': 'Progesterone measurement (procedure)'}, {'cui': 'C0039512', 'cui_str': 'Teniposide'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy (procedure)'}, {'cui': 'C4517420', 'cui_str': 'Zero point one'}, {'cui': 'C4319558', 'cui_str': '200'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1720052', 'cui_str': 'Awakening'}]",172.0,0.437726,"RESULTS Controlling for baseline levels, EPT (vs placebo) led to reductions in minutes to fall asleep (estimate =","[{'ForeName': 'Paul J', 'Initials': 'PJ', 'LastName': 'Geiger', 'Affiliation': 'University of North Carolina at Chapel Hill, Chapel Hill, NC.'}, {'ForeName': 'Tory', 'Initials': 'T', 'LastName': 'Eisenlohr-Moul', 'Affiliation': 'University of Illinois at Chicago, Chicago, IL.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Gordon', 'Affiliation': 'University of Regina, Regina, Saskatchewan, Canada.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Rubinow', 'Affiliation': 'University of North Carolina at Chapel Hill, Chapel Hill, NC.'}, {'ForeName': 'Susan S', 'Initials': 'SS', 'LastName': 'Girdler', 'Affiliation': 'University of North Carolina at Chapel Hill, Chapel Hill, NC.'}]","Menopause (New York, N.Y.)",['10.1097/GME.0000000000001398'] 688,31511031,"Effects of recombinant human growth hormone treatment on growth, body composition, and safety in infants or toddlers with Prader-Willi syndrome: a randomized, active-controlled trial.","BACKGROUND Prader-Willi syndrome (PWS) is a rare complex genetic disorder and is characterized by short stature, muscular hypotonia, abnormal body composition, psychomotor retardation, and hyperphagia. Recombinant human growth hormone (rhGH) treatment improves the symptoms in children with PWS, and early treatment results in more favorable outcomes. However, systematic studies in infants and toddlers under 2 years of age are lacking. This multicenter, randomized, active-controlled, parallel-group, open-label, Phase III study aimed to evaluate the safety of rhGH (Eutropin, LG Chem, Ltd.) and its efficacy on growth, body composition, and motor and cognitive development in infants and toddlers with PWS compared with a comparator treatment (Genotropin, Pfizer, Inc.). Eligible Korean infants or toddlers with PWS were randomly assigned to receive Eutropin or comparator (both 0.24 mg/kg/week, 6 times/week) for 1 year. Height standard deviation score (SDS), body composition, and motor and cognitive development were measured. RESULTS Thirty-four subjects (less than 24 months old) were randomized into either the Eutropin (N = 17) group or the comparator (N = 17) group. After 52 weeks of rhGH treatment, height SDS and lean body mass increased significantly from baseline in both groups: the mean height SDS change (SD) was 0.75 (0.59) in the Eutropin group and 0.95 (0.66) in the comparator group, and the mean lean body mass change (SD) was 2377.79 (536.25) g in the Eutropin group and 2607.10 (641.36) g in the comparator group. In addition, percent body fat decreased significantly: the mean (SD) change from baseline was - 8.12% (9.86%) in the Eutropin group and - 7.48% (10.26%) in the comparator group. Motor and cognitive developments were also improved in both groups after the 1-year treatment. The incidence of adverse events was similar between the groups. CONCLUSIONS rhGH treatment for 52 weeks in infants and toddlers with PWS improved growth, body composition, and motor and cognitive development, and efficacy and safety outcomes of Eutropin were comparable to those of Genotropin. Hence, Eutropin is expected to provide safe and clinically meaningful improvements in pediatric patients with PWS. TRIAL REGISTRATION The study was registered at ClinicalTrials.gov (identifier: NCT02204163) on July 30, 2014. URL: https://clinicaltrials.gov/ct2/show/NCT02204163?term=NCT02204163&rank=1.",2019,"In addition, percent body fat decreased significantly: the mean (SD) change from baseline was - 8.12% (9.86%) in the Eutropin group and - 7.48% (10.26%) in the comparator group.","['Eligible Korean infants or toddlers with PWS', 'infants or toddlers with Prader-Willi syndrome', 'children with PWS', 'infants and toddlers with PWS compared with a comparator treatment (Genotropin, Pfizer, Inc', 'Thirty-four subjects (less than 24\u2009months old', 'pediatric patients with PWS', 'infants and toddlers under 2\u2009years of age are lacking']","['Eutropin or comparator', 'rhGH (Eutropin, LG Chem, Ltd', 'URL', 'Eutropin', 'Recombinant human growth hormone (rhGH', 'recombinant human growth hormone treatment']","['adverse events', 'Motor and cognitive developments', 'growth, body composition, and motor and cognitive development, and efficacy and safety outcomes of Eutropin', 'mean height SDS change (SD', 'Height standard deviation score (SDS), body composition, and motor and cognitive development', 'growth, body composition, and motor and cognitive development', 'growth, body composition, and safety', 'height SDS and lean body mass']","[{'cui': 'C1556095', 'cui_str': 'Koreans'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0682053', 'cui_str': 'Toddler (qualifier value)'}, {'cui': 'C0032897', 'cui_str': 'Labhart-Willi-Prader-Fanconi Syndrome'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0699616', 'cui_str': 'Genotropin'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0332268', 'cui_str': 'Lacking (qualifier value)'}]","[{'cui': 'C3541384', 'cui_str': 'Uniform resource locator (foundation metadata concept)'}, {'cui': 'C0169964', 'cui_str': 'Somatropin'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0424678', 'cui_str': 'Lean body mass (observable entity)'}]",34.0,0.090014,"In addition, percent body fat decreased significantly: the mean (SD) change from baseline was - 8.12% (9.86%) in the Eutropin group and - 7.48% (10.26%) in the comparator group.","[{'ForeName': 'Aram', 'Initials': 'A', 'LastName': 'Yang', 'Affiliation': 'Department of Pediatrics, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Jin-Ho', 'Initials': 'JH', 'LastName': 'Choi', 'Affiliation': ""Department of Pediatrics, Asan Medical Center Children's Hospital, University of Ulsan College of Medicine, 88 Olympic-ro 43-gil, Songpa-gu, Seoul, 05505, Republic of Korea.""}, {'ForeName': 'Young Bae', 'Initials': 'YB', 'LastName': 'Sohn', 'Affiliation': 'Department of Medical Genetics, Ajou University Hospital, Ajou University School of Medicine, Suwon, Republic of Korea.'}, {'ForeName': 'Yunae', 'Initials': 'Y', 'LastName': 'Eom', 'Affiliation': 'Life Sciences, LG Chem, Ltd, Seoul, Republic of Korea.'}, {'ForeName': 'Jiyoon', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'Life Sciences, LG Chem, Ltd, Seoul, Republic of Korea.'}, {'ForeName': 'Han-Wook', 'Initials': 'HW', 'LastName': 'Yoo', 'Affiliation': ""Department of Pediatrics, Asan Medical Center Children's Hospital, University of Ulsan College of Medicine, 88 Olympic-ro 43-gil, Songpa-gu, Seoul, 05505, Republic of Korea. hwyoo@amc.seoul.kr.""}, {'ForeName': 'Dong-Kyu', 'Initials': 'DK', 'LastName': 'Jin', 'Affiliation': 'Department of Pediatrics, Samsung Medical Center, Sungkyunkwan University School of Medicine, 81 Irwon-ro, Gangnam-gu, Seoul, 06351, Republic of Korea. jindk.jin@samsung.com.'}]",Orphanet journal of rare diseases,['10.1186/s13023-019-1195-1'] 689,31258919,Serum biomarkers and outcomes in patients with moderate COPD: a substudy of the randomised SUMMIT trial.,"Rationale Systemic levels of C reactive protein (CRP), surfactant protein D (SPD), fibrinogen, soluble receptor of activated glycogen end-product (sRAGE) and club cell protein 16 (CC-16) have been associated with chronic obstructive pulmonary disease (COPD) outcomes. However, they require validation in different cohorts. Objectives Relate systemic levels of those proteins to forced expiratory volume in 1 s (FEV 1 ) decline, exacerbations, hospitalisations and mortality in COPD patients (FEV 1 of ≥50 and ≤70% predicted) and heightened cardiovascular risk in a substudy of the Study to Understand Mortality and MorbidITy trial. Methods Participants were randomised to daily inhalations of placebo, vilanterol 25 µg (VI), fluticasone furoate 100 µg (FF) or their combination (VI 25/FF 100) and followed quarterly until 1000 deaths in the overall 16 485 participants occurred. Biomarker blood samples were available from 1673 patients. The FEV 1 decline (mL/year), COPD exacerbations, hospitalisations and death were determined. Associations between biomarker levels and outcomes were adjusted by age and gender. Results Systemic levels of CC-16, CRP, sRAGE, SPD and fibrinogen did not relate to baseline FEV 1 , FEV 1 decline, exacerbations or hospitalisations. Fibrinogen and CRP were related to mortality over a median follow-up of 2.3 years. Only the CC-16 changed with study therapy (VI, FF and FF/VI, p<0.01) at 3 months. Conclusions In COPD, systemic levels of CC-16, CRP, sRAGE, SPD and fibrinogen were not associated with FEV 1 decline, exacerbations or hospitalisations. These results cast doubts about the clinical usefulness of the systemic levels of these proteins as surrogate markers of these COPD outcomes. The study confirms that CRP and fibrinogen are associated with increased risk of death in patients with COPD. Trial registration number NCT01313676.",2019,"Systemic levels of CC-16, CRP, sRAGE, SPD and fibrinogen did not relate to baseline FEV 1 , FEV 1 decline, exacerbations or hospitalisations.","['patients with COPD', '1673 patients', 'patients with moderate COPD']","['placebo, vilanterol 25 µg (VI), fluticasone furoate 100 µg (FF) or their combination (VI 25/FF 100']","['Systemic levels of CC-16, CRP, sRAGE, SPD and fibrinogen did not relate to baseline FEV 1 , FEV 1 decline, exacerbations or hospitalisations', 'COPD, systemic levels of CC-16, CRP, sRAGE, SPD and fibrinogen', 'Fibrinogen and CRP', 'FEV 1 decline (mL/year), COPD exacerbations, hospitalisations and death', 'C reactive protein (CRP), surfactant protein D (SPD), fibrinogen, soluble receptor of activated glycogen end-product (sRAGE', 'risk of death', 'forced expiratory volume in 1\u2009s (FEV 1 ) decline, exacerbations, hospitalisations and mortality']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2935023', 'cui_str': 'vilanterol'}, {'cui': 'C1948374', 'cui_str': 'fluticasone furoate'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}]","[{'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0982156', 'cui_str': 'fibrinogen (125I)'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0740304', 'cui_str': 'COPD exacerbation'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C3536958', 'cui_str': 'Surfactant protein D'}, {'cui': 'C0597357', 'cui_str': 'Receptor (substance)'}, {'cui': 'C0017911', 'cui_str': 'Glycogen'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C1306036', 'cui_str': 'Forced expiratory volume'}, {'cui': 'C0026566', 'cui_str': 'mortality'}]",16485.0,0.41746,"Systemic levels of CC-16, CRP, sRAGE, SPD and fibrinogen did not relate to baseline FEV 1 , FEV 1 decline, exacerbations or hospitalisations.","[{'ForeName': 'Bartolome R', 'Initials': 'BR', 'LastName': 'Celli', 'Affiliation': ""Pulmonary and Critical Care Division, Brigham and Women's Hospital, Boston, Massachusetts, USA.""}, {'ForeName': 'Julie A', 'Initials': 'JA', 'LastName': 'Anderson', 'Affiliation': 'Research & Development, GlaxoSmithKline Plc Stockley Park, Uxbridge, Middlesex, UK.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Brook', 'Affiliation': 'Division of Cardiovascular Medicine, University of Michigan, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Calverley', 'Affiliation': 'Department of Medicine, Clinical Sciences Centre, University of Liverpool, University Hospital Aintree, Liverpool, Liverpool, UK.'}, {'ForeName': 'Nicholas J', 'Initials': 'NJ', 'LastName': 'Cowans', 'Affiliation': 'GlaxoSmithKline Plc Stockley Park, Uxbridge, Middlesex, UK.'}, {'ForeName': 'Courtney', 'Initials': 'C', 'LastName': 'Crim', 'Affiliation': 'GlaxoSmithKline Research Triangle Park, Research Triangle Park, North Carolina, USA.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Dixon', 'Affiliation': 'GlaxoSmithKline Plc Stockley Park, Uxbridge, Middlesex, UK.'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Kim', 'Affiliation': 'Department of Medicine, Temple University School of Medicine, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Fernando J', 'Initials': 'FJ', 'LastName': 'Martinez', 'Affiliation': 'Joan and Sanford I. Weill Department of Medicine, Weill Cornell Medicine Samuel J Wood Library, New York City, New York, USA.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Morris', 'Affiliation': 'GlaxoSmithKline Research Triangle Park, Research Triangle Park, North Carolina, USA.'}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Newby', 'Affiliation': 'British Heart Foundation Centre for Cardiovascular Science, University of Edinburgh, Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Yates', 'Affiliation': 'GlaxoSmithKline Research Triangle Park, Research Triangle Park, North Carolina, USA.'}, {'ForeName': 'Joergen', 'Initials': 'J', 'LastName': 'Vestbo', 'Affiliation': 'Division of Infection, Immunity and Respiratory Medicine and Allergy, Manchester Academic Health Science Centre, The University of Manchester, Central Manchester University Hospitals NHS Foundation Trust, Manchester, UK.'}]",BMJ open respiratory research,['10.1136/bmjresp-2019-000431'] 690,31258920,"Multicentre, open label, randomised controlled trial comparing intermittent versus daily treatment for non-cavitary nodular/bronchiectatic Mycobacterium avium complex lung disease with rifampicin, ethambutol and clarithromycin (iREC): study protocol.","Introduction Standard treatment for nodular/bronchiectatic Mycobacterium avium complex lung disease (NB MAC-LD), excluding severe-status cases, differs between Japan and other countries. Internationally, three-drug combination intermittent treatment (three times a week administration) with macrolide, ethambutol and rifampicin is recommended, but a daily treatment regimen is recommended in Japan. To date, no randomised controlled study directly comparing intermittent treatment with daily treatment has been performed. The purpose of this study is to investigate the usefulness of intermittent treatment. Methods and analysis A total of 140 patients diagnosed with NB MAC-LD in Japan will be randomly assigned, in a 1:1 ratio, to intermittent treatment group or daily treatment group, and three-drug combination therapy with clarithromycin, rifampicin and ethambutol will be continued for 1 year. The primary endpoint is the proportion of patients requiring modification of the initial treatment regimen. Secondary endpoints are adverse events, sputum culture conversion, time to sputum culture conversion, improvement of chest CT findings, change in health-related quality of life score and development of clarithromycin resistance. Ethics and dissemination This trial was approved by the National Hospital Organisation Review Board for Clinical Trials (Headquarters). The results of this study will be reported at a society meeting or published in a peer-review journal.",2019,"Secondary endpoints are adverse events, sputum culture conversion, time to sputum culture conversion, improvement of chest CT findings, change in health-related quality of life score and development of clarithromycin resistance. ","['140 patients diagnosed with NB MAC-LD in Japan', 'non-cavitary nodular/bronchiectatic Mycobacterium avium complex lung disease with']","['clarithromycin, rifampicin and ethambutol', 'rifampicin, ethambutol and clarithromycin (iREC', 'macrolide, ethambutol and rifampicin']","['adverse events, sputum culture conversion, time to sputum culture conversion, improvement of chest CT findings, change in health-related quality of life score and development of clarithromycin resistance', 'proportion of patients requiring modification of the initial treatment regimen']","[{'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0009545', 'cui_str': 'C5b-9'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0205297', 'cui_str': 'Nodular (qualifier value)'}, {'cui': 'C0026914', 'cui_str': 'Mycobacterium avium-intracellulare Complex'}, {'cui': 'C0024115', 'cui_str': 'Pulmonary Diseases'}]","[{'cui': 'C0055856', 'cui_str': 'Clarithromycin'}, {'cui': 'C0035608', 'cui_str': 'rifampicin'}, {'cui': 'C0014964', 'cui_str': 'Ethambutol'}, {'cui': 'C0003240', 'cui_str': 'Substance with macrolide structure and antibacterial mechanism of action (substance)'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0523174', 'cui_str': 'Microbial culture of sputum (procedure)'}, {'cui': 'C0439836', 'cui_str': 'Conversions (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0202823', 'cui_str': 'Chest CT'}, {'cui': 'C2607943', 'cui_str': 'findings'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C0055856', 'cui_str': 'Clarithromycin'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]",140.0,0.09349,"Secondary endpoints are adverse events, sputum culture conversion, time to sputum culture conversion, improvement of chest CT findings, change in health-related quality of life score and development of clarithromycin resistance. ","[{'ForeName': 'Taku', 'Initials': 'T', 'LastName': 'Nakagawa', 'Affiliation': 'Department of Respiratory Medicine, National Hospital Organization Higashinagoya National Hospital, Nagoya, Japan.'}, {'ForeName': 'Hiroya', 'Initials': 'H', 'LastName': 'Hashimoto', 'Affiliation': 'Clinical Research Center, National Hospital Organization Nagoya Medical Center, Nagoya, Japan.'}, {'ForeName': 'Mitsuaki', 'Initials': 'M', 'LastName': 'Yagi', 'Affiliation': 'Department of Respiratory Medicine, National Hospital Organization Higashinagoya National Hospital, Nagoya, Japan.'}, {'ForeName': 'Yoshihito', 'Initials': 'Y', 'LastName': 'Kogure', 'Affiliation': 'Department of Respiratory Medicine, National Hospital Organization Nagoya Medical Center, Nagoya, Japan.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Sekimizu', 'Affiliation': 'Clinical Research Center, National Hospital Organization Nagoya Medical Center, Nagoya, Japan.'}, {'ForeName': 'Akiko M', 'Initials': 'AM', 'LastName': 'Saito', 'Affiliation': 'Clinical Research Center, National Hospital Organization Nagoya Medical Center, Nagoya, Japan.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Ogawa', 'Affiliation': 'Department of Respiratory Medicine, National Hospital Organization Higashinagoya National Hospital, Nagoya, Japan.'}, {'ForeName': 'Yoshikazu', 'Initials': 'Y', 'LastName': 'Inoue', 'Affiliation': 'Clinical Research Center, National Hospital Organization Kinki-Chuo Chest Medical Center, Sakai, Japan.'}]",BMJ open respiratory research,['10.1136/bmjresp-2019-000434'] 691,31623857,"Safety lead-in of the MEK inhibitor trametinib in combination with GSK2141795, an AKT inhibitor, in patients with recurrent endometrial cancer: An NRG Oncology/GOG study.","OBJECTIVE We sought to determine safety and efficacy of the AKT inhibitor, GSK2141795, combined with the MEK inhibitor, trametinib, in endometrial cancer. METHODS Patients with measurable recurrent endometrial cancer were eligible. One to two prior cytotoxic regimens were allowed; prior use of a MEK or PI3K pathway inhibitor was excluded. Initial trial design consisted of a KRAS mutation stratified randomized phase II with a safety lead-in evaluating the combination. For the safety lead in, the previously recommended phase 2 dose (RP2D; trametinib 1.5 mg, GSK2141795 50 mg) was chosen for Dose Level 1 (DL1). RESULTS Of 26 enrolled patients, 14 were treated on DL1 and 12 were treated on DL-1 (trametinib 1.5 mg, GSK2141795 25 mg). Most common histologies were endometrioid (58%) and serous (27%). Four of 25 (16%) patients were KRAS mutant. Dose limiting toxicities (DLTs) were assessed during cycle 1. DL1 had 8 DLTs (hypertension (n = 2), mucositis (2), rash (2), dehydration, stroke/acute kidney injury). DL1 was deemed non-tolerable so DL-1 was explored. DL-1 had no DLTs. Sixty-five percent of patients had ≥ grade 3 toxicity. There were no responses in DL1 (0%, 90%CI 0-15%) and 1 response in DL-1 (8.3%, 90%CI 0.4-33.9%). Proportion PFS at 6 months for DL1 is 14%, and 25% for DL-1. CONCLUSION The combination of trametinib and GSK2141795 had high levels of toxicity in endometrial cancer at the previously RP2D but was tolerable at a reduced dose. Due to insufficient preliminary efficacy at a tolerable dose, the Phase II study was not initiated.",2019,"There were no responses in DL1 (0%, 90%CI 0-15%) and 1 response in DL-1 (8.3%, 90%CI 0.4-33.9%).","['26 enrolled patients, 14 were treated on DL1 and 12 were treated on DL-1', 'patients with recurrent endometrial cancer', 'Patients with measurable recurrent endometrial cancer were eligible']",[],"['DL1', 'toxicity', 'Dose limiting toxicities (DLTs', 'mucositis (2), rash (2), dehydration, stroke/acute kidney injury']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0476089', 'cui_str': 'Endometrial Carcinoma'}]",[],"[{'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0439801', 'cui_str': 'Limited (qualifier value)'}, {'cui': 'C0333355', 'cui_str': 'Mucositis'}, {'cui': 'C0015230', 'cui_str': 'Skin Rash'}, {'cui': 'C0011175', 'cui_str': 'Dehydration'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C2609414', 'cui_str': 'Acute Renal Injury'}]",26.0,0.0759544,"There were no responses in DL1 (0%, 90%CI 0-15%) and 1 response in DL-1 (8.3%, 90%CI 0.4-33.9%).","[{'ForeName': 'Shannon N', 'Initials': 'SN', 'LastName': 'Westin', 'Affiliation': 'Department of Gynecologic Oncology, University of Texas M. D Anderson Cancer Center, USA. Electronic address: swestin@mdanderson.org.'}, {'ForeName': 'Michael W', 'Initials': 'MW', 'LastName': 'Sill', 'Affiliation': 'NRG Oncology Statistics and Data Management Center Buffalo Office, Roswell Park Cancer Institute, USA. Electronic address: SillM@NRGOncology.org.'}, {'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Coleman', 'Affiliation': 'Department of Gynecologic Oncology, University of Texas M. D Anderson Cancer Center, USA. Electronic address: rcoleman@mdanderson.org.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Waggoner', 'Affiliation': 'Department of Gynecologic Oncology, Case Western Reserve University, USA. Electronic address: Steven.Waggoner@UHhospitals.org.'}, {'ForeName': 'Kathleen N', 'Initials': 'KN', 'LastName': 'Moore', 'Affiliation': 'Department of Gynecologic Oncology, University of Oklahoma Health Sciences Center, Stephenson Cancer Center, USA. Electronic address: Kathleen-moore@ouhsc.edu.'}, {'ForeName': 'Cara A', 'Initials': 'CA', 'LastName': 'Mathews', 'Affiliation': 'Department of Gynecologic Oncology, Women & Infants Hospital, USA. Electronic address: cmathews@wihri.org.'}, {'ForeName': 'Lainie P', 'Initials': 'LP', 'LastName': 'Martin', 'Affiliation': 'Department of Hematology/Oncology, Fox Chase Cancer Center, USA. Electronic address: lainie.martin@uphs.upenn.edu.'}, {'ForeName': 'Susan C', 'Initials': 'SC', 'LastName': 'Modesitt', 'Affiliation': 'Director of Gynecologic Oncology Division, University of Virginia, USA. Electronic address: scm6h@virginia.edu.'}, {'ForeName': 'Sanghoon', 'Initials': 'S', 'LastName': 'Lee', 'Affiliation': 'Department of Medicine and the UVA Cancer Center, University of Virginia, USA. Electronic address: SLee29@mdanderson.org.'}, {'ForeName': 'Zhenlin', 'Initials': 'Z', 'LastName': 'Ju', 'Affiliation': 'Department of Bioinformatics and Computational Biology, University of Texas M. D Anderson Cancer Center, USA. Electronic address: zju@mdanderson.org.'}, {'ForeName': 'Gordon B', 'Initials': 'GB', 'LastName': 'Mills', 'Affiliation': 'Department of Medicine and the UVA Cancer Center, University of Virginia, USA. Electronic address: millsg@ohsu.edu.'}, {'ForeName': 'Russell J', 'Initials': 'RJ', 'LastName': 'Schilder', 'Affiliation': 'Department of Medical Oncology, Sidney Kimmel Cancer Center, Thomas Jefferson University Hospital, USA. Electronic address: russell.schilder@jefferson.edu.'}, {'ForeName': 'Paula M', 'Initials': 'PM', 'LastName': 'Fracasso', 'Affiliation': 'Department of Systems Biology, University of Texas M.D Anderson Cancer Center, USA. Electronic address: fracasso@virginia.edu.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Birrer', 'Affiliation': 'OB/GYN and Pathology, University of Alabama at Birmingham, USA. Electronic address: mbirrer@uab.edu.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Aghajanian', 'Affiliation': 'Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, USA. Electronic address: aghajanc@mskcc.org.'}]",Gynecologic oncology,['10.1016/j.ygyno.2019.09.024'] 692,31339533,Effectiveness of the American College of Surgeons Bleeding Control Basic Training Among Laypeople Applying Different Tourniquet Types: A Randomized Clinical Trial.,"Importance More than 500 000 laypeople in the United States have been trained in hemorrhage control, including tourniquet application, under the Stop the Bleed campaign. However, it is unclear whether after hemorrhage control training participants become proficient in a specific type of tourniquet or can also use other tourniquets effectively. Objective To assess whether participants completing the American College of Surgeons Bleeding Control Basic (B-Con) training with Combat Application Tourniquets (CATs) can effectively apply bleeding control principles using other tourniquet types (commercial and improvised). Design, Setting, and Participants This nonblinded, crossover, sequential randomized clinical trial with internal control assessed a volunteer sample of laypeople who attended a B-Con course at Gillette Stadium and the Longwood Medical Area in Boston, Massachusetts, for correct application of each of 5 different tourniquet types immediately after B-Con training from April 4, 2018, to October 9, 2018. The order of application varied for each participant using randomly generated permutated blocks. Interventions Full B-Con course, including cognitive and skill sessions, that taught bleeding care, wound pressure and packing, and CAT application. Main Outcomes and Measures Correct tourniquet application (applied pressure of ≥250 mm Hg with a 2-minute time cap) in a simulated scenario for 3 commercial tourniquets (Special Operation Forces Tactical Tourniquet, Stretch-Wrap-and-Tuck Tourniquet, and Rapid Application Tourniquet System) and improvised tourniquet compared with correct CAT application as an internal control using 4 pairwise Bonferroni-corrected comparisons with the McNemar test. Results A total of 102 participants (50 [49.0%] male; median [interquartile range] age, 37.5 [27.0-53.0] years) were included in the study. Participants correctly applied the CAT at a significantly higher rate (92.2%) than all other commercial tourniquet types (Special Operation Forces Tactical Tourniquet, 68.6%; Stretch-Wrap-and-Tuck Tourniquet, 11.8%; Rapid Application Tourniquet System, 11.8%) and the improvised tourniquet (32.4%) (P < .001 for each pairwise comparison). When comparing tourniquets applied correctly, all tourniquet types had higher estimated blood loss, had longer application time, and applied less pressure than the CAT. Conclusions and Relevance The B-Con principles for correct CAT application are not fully translatable to other commercial or improvised tourniquet types. This study demonstrates a disconnect between the B-Con course and tourniquet designs available for bystander first aid, potentially stemming from the lack of consensus guidelines. These results suggest that current B-Con trainees may not be prepared to care for bleeding patients as tourniquet design evolves. Trial Registration ClinicalTrials.gov identifier: NCT03538379.",2019,"Participants correctly applied the CAT at a significantly higher rate (92.2%) than all other commercial tourniquet types (Special Operation Forces Tactical Tourniquet, 68.6%; Stretch-Wrap-and-Tuck Tourniquet, 11.8%;","['participants completing the American College of Surgeons', 'A total of 102 participants (50 [49.0%] male; median [interquartile range] age, 37.5 [27.0-53.0] years) were included in the study', 'volunteer sample of laypeople who attended a B-Con course at Gillette Stadium and the Longwood Medical Area in Boston, Massachusetts, for correct application of each of 5 different tourniquet types immediately after B-Con training from April 4, 2018, to October 9, 2018', 'American College of Surgeons Bleeding Control Basic Training Among Laypeople Applying Different Tourniquet Types']",['Bleeding Control Basic (B-Con) training with Combat Application Tourniquets (CATs'],"['commercial tourniquets (Special Operation Forces Tactical Tourniquet, Stretch-Wrap-and-Tuck Tourniquet, and Rapid Application Tourniquet System) and improvised tourniquet compared with correct CAT application as an internal control using 4 pairwise Bonferroni-corrected comparisons with the McNemar test', 'blood loss', 'Measures\n\n\nCorrect tourniquet application (applied pressure of ≥250 mm Hg with a 2-minute time cap']","[{'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517742', 'cui_str': '37.5 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0750729', 'cui_str': 'Courses (qualifier value)'}, {'cui': 'C0442588', 'cui_str': 'Stadium (environment)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0006037', 'cui_str': 'Boston'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}, {'cui': 'C0040519', 'cui_str': 'Tourniquets'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0582175', 'cui_str': 'Surgeon (occupation)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1632850', 'cui_str': 'Apply'}]","[{'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}, {'cui': 'C0040519', 'cui_str': 'Tourniquets'}, {'cui': 'C0524517', 'cui_str': 'Felis'}]","[{'cui': 'C0040519', 'cui_str': 'Tourniquets'}, {'cui': 'C0205555', 'cui_str': 'Special (qualifier value)'}, {'cui': 'C0038895', 'cui_str': 'operative therapy'}, {'cui': 'C0443221', 'cui_str': 'Forced (qualifier value)'}, {'cui': 'C0600080', 'cui_str': 'Stretching procedure (procedure)'}, {'cui': 'C0445414', 'cui_str': 'Wrapping (procedure)'}, {'cui': 'C0185026', 'cui_str': 'Plication - action (qualifier value)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0205202', 'cui_str': 'Remediated'}, {'cui': 'C0524517', 'cui_str': 'Felis'}, {'cui': 'C0205102', 'cui_str': 'Internal (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0204731', 'cui_str': 'Application of tourniquet (procedure)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0179586', 'cui_str': 'Cap (physical object)'}]",102.0,0.0461564,"Participants correctly applied the CAT at a significantly higher rate (92.2%) than all other commercial tourniquet types (Special Operation Forces Tactical Tourniquet, 68.6%; Stretch-Wrap-and-Tuck Tourniquet, 11.8%;","[{'ForeName': 'Justin C', 'Initials': 'JC', 'LastName': 'McCarty', 'Affiliation': ""Center for Surgery and Public Health, Department of Surgery, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Zain G', 'Initials': 'ZG', 'LastName': 'Hashmi', 'Affiliation': ""Center for Surgery and Public Health, Department of Surgery, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Juan P', 'Initials': 'JP', 'LastName': 'Herrera-Escobar', 'Affiliation': ""Center for Surgery and Public Health, Department of Surgery, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Elzerie', 'Initials': 'E', 'LastName': 'de Jager', 'Affiliation': ""Center for Surgery and Public Health, Department of Surgery, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Muhammad Ali', 'Initials': 'MA', 'LastName': 'Chaudhary', 'Affiliation': ""Center for Surgery and Public Health, Department of Surgery, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Stuart R', 'Initials': 'SR', 'LastName': 'Lipsitz', 'Affiliation': ""Center for Surgery and Public Health, Department of Surgery, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Molly', 'Initials': 'M', 'LastName': 'Jarman', 'Affiliation': ""Center for Surgery and Public Health, Department of Surgery, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Edward J', 'Initials': 'EJ', 'LastName': 'Caterson', 'Affiliation': ""Center for Surgery and Public Health, Department of Surgery, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Goralnick', 'Affiliation': ""Center for Surgery and Public Health, Department of Surgery, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}]",JAMA surgery,['10.1001/jamasurg.2019.2275'] 693,30851137,"Randomized within-subject trial to evaluate smokers' initial perceptions, subjective effects and nicotine delivery across six vaporized nicotine products.","BACKGROUND AND AIMS Vaporized nicotine products (VNPs) can vary in important characteristics including size, shape, flavor and nicotine yield. We examined whether complex interactions among these characteristics could affect smokers' VNP perceptions and usage patterns. DESIGN A within-subject randomized cross-over trial. SETTING Roswell Park Comprehensive Cancer Center, Buffalo, NY, USA. PARTICIPANTS Eighteen daily cigarette smokers. MEASUREMENTS Participants attended eight weekly visits during which they sampled six different VNPs (disposable, rechargeable, eGO, mod, e-Cigar and e-Pipe) with tobacco-flavored e-liquid. Prior to device use, participants completed product-ranking questionnaires. Participants completed controlled puffing sessions during each of the six trials, after which satisfaction questionnaires were completed and blood samples were taken. FINDINGS Initial perceptions showed that the smallest device (disposable) was ranked as safer compared with a larger device (e-Pipe) (P < 0.05). Participants rated the eGO and mod devices higher on satisfaction and enjoyment from use, taste, pleasantness, harshness ('throat hit') and speed of effect, but lower on perceived health risk and embarrassment from use (P < 0.05). All devices had a lower C max than the combustible cigarette (P < 0.05), but there were differences among devices (P < 0.05). The mod, e-Pipe and eGO provided the highest amount of perceived smoking urge relief, and this correlated strongly with C max across all devices (R 2  = 0.8614, P = 0.007). The perceived speed of urge relief was not correlated with T max (R 2  = 0.0035, P = 0.911) CONCLUSIONS: Daily cigarette smokers testing six types of vaporized nicotine products (VNPs) reported that they varied in taste, amount of withdrawal relief, harshness, embarrassment from use, perceived health risk and subjective and objective nicotine delivery. The eGO and mod models have properties that may make them most effective for cigarette substitution among smokers who intend to switch to a VNP.",2019,"Participants rated the eGO and mod devices higher on satisfaction and enjoyment from use, taste, pleasantness, harshness ('throat hit') and speed of effect, but lower on perceived health risk and embarrassment from use (P < 0.05).","['Daily cigarette smokers testing six types of', 'Eighteen daily cigarette smokers', 'Participants attended eight weekly visits during which they sampled six different VNPs (disposable, rechargeable, eGO, mod, e-Cigar and e-Pipe) with tobacco-flavored e-liquid']",['vaporized nicotine products (VNPs'],"['perceived health risk and embarrassment', ""satisfaction and enjoyment from use, taste, pleasantness, harshness ('throat hit') and speed of effect"", 'speed of urge relief']","[{'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0337667', 'cui_str': 'Cigarette smoker (finding)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C3715206', 'cui_str': 'Eighteen'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0205452', 'cui_str': 'Six'}, {'cui': 'C0013712', 'cui_str': 'Ego'}, {'cui': 'C0026766', 'cui_str': 'Organ Dysfunction Syndrome, Multiple'}, {'cui': 'C0678446', 'cui_str': 'Cigars'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0071109', 'cui_str': ""piperazine-N,N'-bis(2-ethanesulfonic acid), sodium salt""}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C4543628', 'cui_str': 'Electronic cigarette liquid (physical object)'}]","[{'cui': 'C0028040', 'cui_str': 'Nicotine'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0679112', 'cui_str': 'Embarrassment'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0039336', 'cui_str': 'Gustation'}, {'cui': 'C0234804', 'cui_str': 'Harsh voice quality (finding)'}, {'cui': 'C0230069', 'cui_str': 'Structure of anterior portion of neck'}, {'cui': 'C0596020', 'cui_str': 'Does hit (finding)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C1301676', 'cui_str': 'Relieves (qualifier value)'}]",18.0,0.0364141,"Participants rated the eGO and mod devices higher on satisfaction and enjoyment from use, taste, pleasantness, harshness ('throat hit') and speed of effect, but lower on perceived health risk and embarrassment from use (P < 0.05).","[{'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Voos', 'Affiliation': 'Department of Health Behavior, Roswell Park Comprehensive Cancer Center, USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Kaiser', 'Affiliation': 'Department of Health Behavior, Roswell Park Comprehensive Cancer Center, USA.'}, {'ForeName': 'Martin C', 'Initials': 'MC', 'LastName': 'Mahoney', 'Affiliation': 'Department of Health Behavior, Roswell Park Comprehensive Cancer Center, USA.'}, {'ForeName': 'Clara M', 'Initials': 'CM', 'LastName': 'Bradizza', 'Affiliation': 'Department of Psychiatry, University at Buffalo, NY, USA.'}, {'ForeName': 'Lynn T', 'Initials': 'LT', 'LastName': 'Kozlowski', 'Affiliation': 'School of Public Health and Health Professions, University at Buffalo, NY, USA.'}, {'ForeName': 'Neal L', 'Initials': 'NL', 'LastName': 'Benowitz', 'Affiliation': 'Division of Clinical Pharmacology, Department of Medicine and Bioengineering and Therapeutic Sciences, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': ""O'Connor"", 'Affiliation': 'Department of Health Behavior, Roswell Park Comprehensive Cancer Center, USA.'}, {'ForeName': 'Maciej L', 'Initials': 'ML', 'LastName': 'Goniewicz', 'Affiliation': 'Department of Health Behavior, Roswell Park Comprehensive Cancer Center, USA.'}]","Addiction (Abingdon, England)",['10.1111/add.14602'] 694,30877271,Regional default mode network connectivity in major depressive disorder: modulation by acute intravenous citalopram.,"The relationship between altered default mode network (DMN) connectivity and abnormal serotonin function in major depressive disorder (MDD) has not been investigated. Using intravenous citalopram and resting-state fMRI, we investigated DMN intra-network connectivity and serotonin function in 77 healthy controls and patients with MDD. There were no significant main effects of MDD or citalopram on DMN intra-network connectivity; however, significant interactions indicated that group differences under saline were modified by citalopram. In MDD patients during saline infusion, in contrast with controls, the DMN (i) did not include the precuneus that was instead part of an anti-correlated network but (ii) did include amygdala that was part of the anti-correlated network in controls. Citalopram infusion in MDD patients restored the pattern seen in controls under saline. In healthy controls, citalopram infusion disengaged the precuneus from the DMN and engaged the amygdala, partially reproducing the abnormalities seen under saline in MDD. In exploratory analyses within the MDD group, greater rumination self-ratings were associated with greater intra-network connectivity of the anterior cingulate cortex with the DMN. We hypothesise that, in MDD, disengagement of the precuneus from the DMN relates to overgeneral memory bias in rumination. The opposite effect, with greater engagement of the amygdala in the DMN, reflects the negative valence of rumination. Reversal of these abnormalities by citalopram suggests that they may be related to impaired serotonin function. That citalopram engaged the amygdala in the DMN in controls may relate to the paradoxical effects on aversive processing seen with acute SSRIs in healthy subjects.",2019,"There were no significant main effects of MDD or citalopram on DMN intra-network connectivity; however, significant interactions indicated that group differences under saline were modified by citalopram.","['major depressive disorder (MDD', 'major depressive disorder', 'healthy subjects', '77 healthy controls and patients with MDD']","['Citalopram', 'citalopram']","['rumination self-ratings', 'DMN intra-network connectivity']","[{'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0008845', 'cui_str': 'Citalopram'}]","[{'cui': 'C0154575', 'cui_str': 'Rumination Disorders'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}]",77.0,0.0426471,"There were no significant main effects of MDD or citalopram on DMN intra-network connectivity; however, significant interactions indicated that group differences under saline were modified by citalopram.","[{'ForeName': 'Arpan', 'Initials': 'A', 'LastName': 'Dutta', 'Affiliation': 'Neuroscience & Psychiatry Unit, Institute of Brain, Behaviour and Mental Health and Manchester Academic Health Sciences Centre, Stopford Building, University of Manchester, Manchester, M13 9PT, UK. arpan.dutta@manchester.ac.uk.'}, {'ForeName': 'Shane', 'Initials': 'S', 'LastName': 'McKie', 'Affiliation': 'Neuroscience & Psychiatry Unit, Institute of Brain, Behaviour and Mental Health and Manchester Academic Health Sciences Centre, Stopford Building, University of Manchester, Manchester, M13 9PT, UK.'}, {'ForeName': 'Darragh', 'Initials': 'D', 'LastName': 'Downey', 'Affiliation': 'Neuroscience & Psychiatry Unit, Institute of Brain, Behaviour and Mental Health and Manchester Academic Health Sciences Centre, Stopford Building, University of Manchester, Manchester, M13 9PT, UK.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Thomas', 'Affiliation': 'Neuroscience & Psychiatry Unit, Institute of Brain, Behaviour and Mental Health and Manchester Academic Health Sciences Centre, Stopford Building, University of Manchester, Manchester, M13 9PT, UK.'}, {'ForeName': 'Gabriella', 'Initials': 'G', 'LastName': 'Juhasz', 'Affiliation': 'Neuroscience & Psychiatry Unit, Institute of Brain, Behaviour and Mental Health and Manchester Academic Health Sciences Centre, Stopford Building, University of Manchester, Manchester, M13 9PT, UK.'}, {'ForeName': 'Danilo', 'Initials': 'D', 'LastName': 'Arnone', 'Affiliation': ""Centre for Affective Disorders, Institute of Psychiatry, Psychology and Neuroscience, King's College London, De Crespigny Park, London, SE5 8AF, UK.""}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Elliott', 'Affiliation': 'Neuroscience & Psychiatry Unit, Institute of Brain, Behaviour and Mental Health and Manchester Academic Health Sciences Centre, Stopford Building, University of Manchester, Manchester, M13 9PT, UK.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Williams', 'Affiliation': 'Centre for Imaging Science and Manchester Academic Health Sciences Centre, Stopford Building, University of Manchester, Manchester, M13 9PT, UK.'}, {'ForeName': 'J F William', 'Initials': 'JFW', 'LastName': 'Deakin', 'Affiliation': 'Neuroscience & Psychiatry Unit, Institute of Brain, Behaviour and Mental Health and Manchester Academic Health Sciences Centre, Stopford Building, University of Manchester, Manchester, M13 9PT, UK.'}, {'ForeName': 'Ian M', 'Initials': 'IM', 'LastName': 'Anderson', 'Affiliation': 'Neuroscience & Psychiatry Unit, Institute of Brain, Behaviour and Mental Health and Manchester Academic Health Sciences Centre, Stopford Building, University of Manchester, Manchester, M13 9PT, UK.'}]",Translational psychiatry,['10.1038/s41398-019-0447-0'] 695,30878435,The Association of Coronary Artery Calcification With Subsequent Incidence of Cardiovascular Disease in Type 1 Diabetes: The DCCT/EDIC Trials.,"OBJECTIVES This study sought to determine the relationship between coronary artery calcium (CAC) scores and subsequent cardiovascular disease (CVD) events in DCCT (Diabetes Control and Complications Trial)/EDIC (Epidemiology of Diabetes Interventions and Complications) participants. BACKGROUND The CAC score has been validated for improved risk stratification in general populations; however, this association has not been well studied in type 1 diabetes (T1DM). METHODS Computed tomography (CT) to measure CAC was performed in 1,205 DCCT/EDIC participants at a mean of 42.8 years of age during EDIC years 7 to 9, after the end of DCCT. This study analyzed the association between CAC and time to the first subsequent CVD event or to the first major adverse cardiac event (MACE), a follow-up of 10 to 13 years. CAC was categorized as: 0, >0 to 100, >100 to 300, or >300 Agatston units. RESULTS Of 1,156 participants at risk for subsequent CVD, 105 had an initial CVD event (8.5 per 1,000 patient-years); and of 1,187 participants at risk for MACE, 51 had an initial MACE event (3.9 per 1,000 patient-years). Event rates among those with scores of zero (n = 817 [70.7%]) were very low for CVD (5.6 per 1,000 patient years). CAC scores >100 to 300 (hazard ratio [HR]: 4.17, 5.40) and >300 (HR: 6.06, 6.91) were associated with higher risks of CVD and MACE, respectively, compared to CAC of 0 (p < 0.0001). CAC scores >0 to 100 were nominally associated with CVD (HR: 1.71; p = 0.0415) but not with MACE (HR: 1.11; p = 0.8134). Similar results were observed when also adjusted for mean HbA 1c and conventional CVD risk factors. The increment in the AUC due to CAC was modest. CONCLUSIONS CAC scores >100 Agatston units were significantly associated with an increased risk of the subsequent occurrence of CVD and MACE in DCCT/EDIC cohort. (Diabetes Control and Complications Trial [DCCT]; NCT00360815; Epidemiology of Diabetes Interventions and Complications [EDIC]; NCT00360893).",2019,"Event rates among those with scores of zero (n = 817 [70.7%]) were very low for CVD (5.6 per 1,000 patient years).","['105 had an initial CVD event (8.5 per 1,000 patient-years); and of 1,187 participants at risk for MACE, 51 had an initial MACE event (3.9 per 1,000 patient-years', 'Type 1 Diabetes', '1,205 DCCT/EDIC participants at a mean of 42.8 years of age during EDIC years 7 to 9, after the end of DCCT', '1,156 participants at risk for subsequent CVD']",['Computed tomography (CT'],"['coronary artery calcium (CAC) scores and subsequent cardiovascular disease (CVD) events', 'mean HbA 1c and conventional CVD risk factors', 'CAC scores', 'higher risks of CVD and MACE']","[{'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C4517877', 'cui_str': '8.5'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0349381', 'cui_str': 'Mace (substance)'}, {'cui': 'C4517698', 'cui_str': '3.9 (qualifier value)'}, {'cui': 'C0441729', 'cui_str': 'Type 1 (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1272693', 'cui_str': 'Ended'}]","[{'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}]","[{'cui': 'C3484386', 'cui_str': 'Coronary artery calcium score'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0332167', 'cui_str': 'High risk of (contextual qualifier) (qualifier value)'}, {'cui': 'C0349381', 'cui_str': 'Mace (substance)'}]",1205.0,0.0368121,"Event rates among those with scores of zero (n = 817 [70.7%]) were very low for CVD (5.6 per 1,000 patient years).","[{'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Budoff', 'Affiliation': 'Los Angeles Biomedical Research Institute at Harbor-University of California Los Angeles School of Medicine, Torrance, California. Electronic address: Budoff@ucla.edu.'}, {'ForeName': 'Jye-Yu C', 'Initials': 'JC', 'LastName': 'Backlund', 'Affiliation': 'Department of Biostatistics, George Washington University, Rockville, Maryland.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Bluemke', 'Affiliation': 'Department of Radiology, University of Wisconsin School of Medicine and Public Health, Madison, Wisconsin.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Polak', 'Affiliation': 'Department of Medicine, Lemuel Shattuck Hospital and Tufts University School of Medicine, Boston, Massachusetts.'}, {'ForeName': 'Ionut', 'Initials': 'I', 'LastName': 'Bebu', 'Affiliation': 'Department of Biostatistics, George Washington University, Rockville, Maryland.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Schade', 'Affiliation': 'Department of Medicine, University of New Mexico, Albuquerque, New Mexico.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Strowig', 'Affiliation': 'Department of Medicine, University of Texas Southwestern Medical Center, Dallas, Texas.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Raskin', 'Affiliation': 'Department of Medicine, University of Texas Southwestern Medical Center, Dallas, Texas.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Lachin', 'Affiliation': 'Department of Biostatistics, George Washington University, Rockville, Maryland.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JACC. Cardiovascular imaging,['10.1016/j.jcmg.2019.01.014'] 696,30807767,Preconception folate status and reproductive outcomes among a prospective cohort of folate-replete women.,"BACKGROUND Most studies of folate metabolism and reproduction have been conducted after pregnancy and in folate-deficient populations. However, measurement of maternal folate status preconceptionally may be most relevant to certain folate-linked early processes preceding a successful pregnancy, and there has been a major increase in folate concentrations in women of childbearing age in high resource settings. OBJECTIVE To examine associations between preconceptional biomarkers of maternal folate status (folate and homocysteine) and reproductive outcomes in folate-replete women. STUDY DESIGN Cohort nested within the Effects of Aspirin in Gestation and Reproduction trial, a block-randomized, double-blind, placebo-controlled trial whereby women were randomized to daily low-dose aspirin (81 mg/day) or placebo and all women received folic acid (400 μg/day). In total, 1228 women with 1-2 previous pregnancy losses and no documented infertility were recruited from 4 clinical sites in the United States (2006-2012) and were attempting pregnancy for up to 6 menstrual cycles. Log-binomial regression models were used to estimate relative risks and 95% confidence intervals between preconception serum folate and plasma homocysteine for anovulation, pregnancy, and pregnancy loss. RESULTS Greater plasma homocysteine was nonlinearly associated with greater risks of pregnancy loss only among women with 2 previous losses: a relative risk of 1.43 (95% confidence interval, 1.08-1.89) was found for plasma homocysteine concentrations at the study median of 8.0 μmol/L compared with a US population median of 6.0 μmol/L. No meaningful relationships were found between serum folate and any reproductive outcome or between plasma homocysteine and anovulation or becoming pregnant. CONCLUSION These data justify further study of the role of folate and homocysteine metabolism in normal and abnormal early pregnancy.",2019,"No meaningful relationships were found between serum folate and any reproductive outcome or between plasma homocysteine and anovulation or becoming pregnant. ","['women of childbearing age in high resource settings', '1228 women with 1-2 previous pregnancy losses and no documented infertility were recruited from 4 clinical sites in the United States (2006-2012) and were attempting pregnancy for up to 6 menstrual cycles', 'folate-replete women', 'prospective cohort of folate-replete women']","['folic acid', 'Aspirin', 'placebo', 'aspirin']","['plasma homocysteine and anovulation or becoming pregnant', 'plasma homocysteine concentrations', 'risks of pregnancy loss', 'folate concentrations', 'preconception serum folate and plasma homocysteine for anovulation, pregnancy, and pregnancy loss', 'plasma homocysteine', 'maternal folate status (folate and homocysteine) and reproductive outcomes']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0600457', 'cui_str': 'Gravidity'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C0021359', 'cui_str': 'Infertility'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C4553712', 'cui_str': 'Onset of menstrual cycle'}, {'cui': 'C0178638', 'cui_str': 'Folate'}]","[{'cui': 'C0016410', 'cui_str': 'Folic Acid'}, {'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0019878', 'cui_str': '2-amino-4-mercaptobutyric acid'}, {'cui': 'C0003128', 'cui_str': 'Anovulation'}, {'cui': 'C0549206', 'cui_str': 'Pregnancy not delivered'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0687675', 'cui_str': 'Pregnancy loss'}, {'cui': 'C0178638', 'cui_str': 'Folate'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}]",1228.0,0.372994,"No meaningful relationships were found between serum folate and any reproductive outcome or between plasma homocysteine and anovulation or becoming pregnant. ","[{'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'DeVilbiss', 'Affiliation': 'Epidemiology Branch, Division of Intramural Population Health Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, MD.'}, {'ForeName': 'Sunni L', 'Initials': 'SL', 'LastName': 'Mumford', 'Affiliation': 'Epidemiology Branch, Division of Intramural Population Health Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, MD.'}, {'ForeName': 'Lindsey A', 'Initials': 'LA', 'LastName': 'Sjaarda', 'Affiliation': 'Epidemiology Branch, Division of Intramural Population Health Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, MD.'}, {'ForeName': 'Matthew T', 'Initials': 'MT', 'LastName': 'Connell', 'Affiliation': 'Epidemiology Branch, Division of Intramural Population Health Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, MD.'}, {'ForeName': 'Keewan', 'Initials': 'K', 'LastName': 'Kim', 'Affiliation': 'Epidemiology Branch, Division of Intramural Population Health Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, MD.'}, {'ForeName': 'James L', 'Initials': 'JL', 'LastName': 'Mills', 'Affiliation': 'Epidemiology Branch, Division of Intramural Population Health Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, MD.'}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Silver', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Utah, Salt Lake City, UT.'}, {'ForeName': 'Enrique F', 'Initials': 'EF', 'LastName': 'Schisterman', 'Affiliation': 'Epidemiology Branch, Division of Intramural Population Health Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, MD. Electronic address: schistee@mail.nih.gov.'}]",American journal of obstetrics and gynecology,['10.1016/j.ajog.2019.02.039'] 697,30776384,Corneal Higher-Order Aberrations in Descemet Membrane Endothelial Keratoplasty versus Ultrathin DSAEK in the Descemet Endothelial Thickness Comparison Trial: A Randomized Clinical Trial.,"PURPOSE To compare corneal higher-order aberrations (HOA) after ultrathin Descemet stripping automated endothelial keratoplasty (DSAEK) and Descemet membrane endothelial keratoplasty (DMEK). DESIGN Patient- and outcome-masked randomized controlled clinical trial. PARTICIPANTS Patients with damaged or diseased endothelium from Fuchs endothelial dystrophy or pseudophakic bullous keratopathy who were good candidates for DMEK or ultrathin DSAEK. METHODS Corneal anterior and posterior surface HOA were measured with Scheimpflug imaging before surgery and at 3, 6, and 12 months after surgery. HOA after ultrathin DSAEK and DMEK were compared; correlation was performed between best spectacle-corrected visual acuity (BSCVA) and HOA at each time point. MAIN OUTCOME MEASURES Higher-order aberrations of the anterior and posterior cornea, expressed as the root mean square deviation from a best fit sphere reference surface. RESULTS At 3, 6, and 12 months after surgery, the posterior corneal surface had significantly less coma (P ≤ 0.003) and total HOA (P ≤ 0.001) in DMEK compared with ultrathin DSAEK (4.0- and 6.0-mm OZ). Posterior trefoil (P ≤ 0.034), secondary astigmatism (P ≤ 0.042), and tetrafoil (P ≤ 0.045) were lower in DMEK than ultrathin DSAEK at 3, 6, or 12 months (either 4.0- or 6.0-mm OZ). There were no significant differences in anterior surface HOA between DMEK and ultrathin DSAEK at any post-surgical time. Compared with baseline, total posterior HOA was increased (P ≤ 0.036) in ultrathin DSAEK at 3, 6, and 12 months, in contrast to DMEK, where it was decreased (P ≤ 0.044) at 6 and 12 months (4.0- or 6.0-mm OZ, or both). At 6 and 12 months, posterior corneal total HOA correlated with BSCVA (ρ ≤ 0.635, P ≤ 0.001; 4.0- and 6.0-mm OZ). There were no moderate or strong correlations between anterior or combined corneal surface HOA at any time point after surgery. CONCLUSIONS Descemet membrane endothelial keratoplasty results in less posterior corneal HOA compared with ultrathin DSAEK. Descemet membrane endothelial keratoplasty decreases and ultrathin DSAEK increases posterior corneal HOA compared with presurgical values. Total posterior corneal HOA correlates with 6- and 12-month postoperative visual acuity and may account for the better visual acuity observed after DMEK.",2019,"Compared with baseline, total posterior HOA was increased (P ≤ 0.036) in ultrathin DSAEK at 3, 6, and 12 months, in contrast to DMEK, where it was decreased (P ≤ 0.044) at 6 and 12 months (4.0- or 6.0-mm OZ, or both).",['Patients with damaged or diseased endothelium from Fuchs endothelial dystrophy or pseudophakic bullous keratopathy who were good candidates for DMEK or ultrathin DSAEK'],"['Descemet Membrane Endothelial Keratoplasty versus Ultrathin DSAEK', 'ultrathin Descemet stripping automated endothelial keratoplasty (DSAEK']","['spectacle-corrected visual acuity (BSCVA) and HOA', 'coma', 'Total posterior corneal HOA correlates', 'visual acuity', 'posterior corneal surface', 'Posterior trefoil', 'anterior surface HOA', 'total posterior HOA', 'Descemet Endothelial Thickness', 'total HOA', 'posterior corneal HOA', 'posterior corneal total HOA', 'Higher-order aberrations of the anterior and posterior cornea, expressed as the root mean square deviation']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0010957', 'cui_str': 'Damage (morphologic abnormality)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0014257', 'cui_str': 'Endothelium'}, {'cui': 'C0333606', 'cui_str': 'Dystrophy (morphologic abnormality)'}, {'cui': 'C0339263', 'cui_str': 'PBK - pseudophakic bullous keratopathy'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}]","[{'cui': 'C4302773', 'cui_str': ""DMEK - Descemet's membrane endothelial keratoplasty""}, {'cui': 'C4302774', 'cui_str': ""Descemet's stripping automated endothelial keratoplasty""}]","[{'cui': 'C0015421', 'cui_str': 'Glasses'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity (observable entity)'}, {'cui': 'C0649652', 'cui_str': 'Benzenamine, 4-(hexyloxy)-'}, {'cui': 'C0009421', 'cui_str': 'Comatose'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0042812', 'cui_str': 'Visual Acuity'}, {'cui': 'C0205148', 'cui_str': 'Surface (attribute)'}, {'cui': 'C0950061', 'cui_str': 'Trefoil'}, {'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C4284072', 'cui_str': 'Order (record artifact)'}, {'cui': 'C0010031', 'cui_str': 'Cornea'}, {'cui': 'C0563017', 'cui_str': 'Anal penetration using finger (finding)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0205120', 'cui_str': 'Square (qualifier value)'}, {'cui': 'C0012727', 'cui_str': 'Displacement (morphologic abnormality)'}]",,0.153349,"Compared with baseline, total posterior HOA was increased (P ≤ 0.036) in ultrathin DSAEK at 3, 6, and 12 months, in contrast to DMEK, where it was decreased (P ≤ 0.044) at 6 and 12 months (4.0- or 6.0-mm OZ, or both).","[{'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Duggan', 'Affiliation': 'Casey Eye Institute, Oregon Health and Science University, Portland, Oregon.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Rose-Nussbaumer', 'Affiliation': 'Francis I. Procter Foundation, University of California, San Francisco, San Francisco, California; Department of Ophthalmology, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Charles C', 'Initials': 'CC', 'LastName': 'Lin', 'Affiliation': 'Byers Eye Institute, Stanford University, Palo Alto, California.'}, {'ForeName': 'Ariana', 'Initials': 'A', 'LastName': 'Austin', 'Affiliation': 'Francis I. Procter Foundation, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Paula C', 'Initials': 'PC', 'LastName': 'Labadzinzki', 'Affiliation': 'Casey Eye Institute, Oregon Health and Science University, Portland, Oregon.'}, {'ForeName': 'Winston D', 'Initials': 'WD', 'LastName': 'Chamberlain', 'Affiliation': 'Casey Eye Institute, Oregon Health and Science University, Portland, Oregon. Electronic address: chamberw@ohsu.edu.'}]",Ophthalmology,['10.1016/j.ophtha.2019.02.007'] 698,31283796,Effect of remote ischemic preconditioning on hemostasis and fibrinolysis in head and neck cancer surgery: A randomized controlled trial.,"INTRODUCTION The aim of this randomized controlled trial was to investigate if remote ischemic preconditioning (RIPC) reduced platelet aggregation and increased fibrinolysis in cancer patients undergoing surgery and thereby reduced the risk of thrombosis. MATERIALS AND METHODS Head and neck cancer patients undergoing tumor resection and microsurgical reconstruction were randomized 1:1 to RIPC or sham intervention. RIPC was administered intraoperatively with an inflatable tourniquet by four cycles of 5-min upper extremity occlusion and 5-min reperfusion. The primary endpoint was collagen-induced platelet aggregation measured with Multiplate as area-under-the-curve on the first postoperative day. Secondary endpoints were markers of primary hemostasis, secondary hemostasis, and fibrinolysis. Clinical data on thromboembolic and bleeding complications were prospectively collected at 30-day follow-up. An intention-to-treat analysis was performed. RESULTS Sixty patients were randomized to RIPC (n = 30) or sham intervention (n = 30). No patients were lost to follow-up. The relative mean [95% confidence interval] collagen-induced platelet aggregation was 1.26 [1.11;1.40] in the RIPC group and 1.17 [1.07;1.27] in the sham group on the first postoperative day reported as ratios compared with baseline (P = 0.30). Median (interquartile range) 50% fibrin clot lysis time was 517 (417-660) sec in the RIPC group and 614 (468-779) sec in the sham group (P = 0.25). The postoperative pulmonary embolism rate did not differ between groups (P = 1.0). CONCLUSIONS RIPC did not influence hemostasis and fibrinolysis in head and neck cancer patients undergoing surgery. RIPC did not reduce the rate of thromboembolic complications.",2019,"The postoperative pulmonary embolism rate did not differ between groups (P = 1.0). ","['Head and neck cancer patients undergoing tumor resection and microsurgical reconstruction', 'head and neck cancer patients undergoing surgery', 'Sixty patients', 'cancer patients undergoing surgery and thereby reduced the risk of thrombosis', 'head and neck cancer surgery']","['RIPC or sham intervention', 'fibrin', 'RIPC', 'sham intervention', 'remote ischemic preconditioning', 'remote ischemic preconditioning (RIPC']","['hemostasis and fibrinolysis', 'markers of primary hemostasis, secondary hemostasis, and fibrinolysis', 'platelet aggregation', 'rate of thromboembolic complications', 'clot lysis time', 'collagen-induced platelet aggregation measured with Multiplate as area-under-the-curve on the first postoperative day', 'postoperative pulmonary embolism rate', 'thromboembolic and bleeding complications']","[{'cui': 'C0278996', 'cui_str': 'Cancer of Head and Neck'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0524865', 'cui_str': 'Reconstructive Surgery'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0040053', 'cui_str': 'Thrombosis'}]","[{'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0015982', 'cui_str': 'Fibrin'}, {'cui': 'C0205157', 'cui_str': 'Remote (qualifier value)'}, {'cui': 'C0475224', 'cui_str': 'Ischemic (qualifier value)'}, {'cui': 'C1709632', 'cui_str': 'Precondition (attribute)'}, {'cui': 'C0376466', 'cui_str': 'Ischemic Pre-Conditioning'}]","[{'cui': 'C0740166', 'cui_str': 'Haemostasis'}, {'cui': 'C1305868', 'cui_str': 'Fibrinolysis'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0677599', 'cui_str': 'Platelet aggregation'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0200464', 'cui_str': 'Clot Lysis Time'}, {'cui': 'C0369863', 'cui_str': 'Collagen induced platelet aggregation'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0034065', 'cui_str': 'Pulmonary Embolism'}]",60.0,0.619051,"The postoperative pulmonary embolism rate did not differ between groups (P = 1.0). ","[{'ForeName': 'Andreas Engel', 'Initials': 'AE', 'LastName': 'Krag', 'Affiliation': 'Thrombosis and Hemostasis Research Unit, Department of Clinical Biochemistry, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Birgitte Jul', 'Initials': 'BJ', 'LastName': 'Kiil', 'Affiliation': 'Department of Plastic and Breast Surgery, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Christine Lodberg', 'Initials': 'CL', 'LastName': 'Hvas', 'Affiliation': 'Department of Intensive Care Medicine, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Anne-Mette', 'Initials': 'AM', 'LastName': 'Hvas', 'Affiliation': 'Thrombosis and Hemostasis Research Unit, Department of Clinical Biochemistry, Aarhus University Hospital, Aarhus, Denmark.'}]",PloS one,['10.1371/journal.pone.0219496'] 699,31315868,"Telehealth and texting intervention to improve HIV care engagement, mental health and substance use outcomes in youth living with HIV: a pilot feasibility and acceptability study protocol.","INTRODUCTION Youth and young adults living with HIV (YLWH) experience worse clinical outcomes than adults and high rates of behavioural health challenges that impact their engagement in care and adherence to antiretroviral therapy. This study in the San Francisco Bay area aims to evaluate the feasibility, acceptability and preliminary clinical outcomes of a 12-session telehealth counselling series provided to 80 YLWH, including education, motivational enhancement and problem-solving around HIV care, mental health, substance use and other challenges. Findings will provide information about benefits and challenges of telehealth counselling for YLWH and will guide the development of new technology-based strategies for care. METHODS AND ANALYSIS The Youth to Telehealth and Text to Improve Engagement in Care study is a pilot randomised, crossover trial examining the feasibility and acceptability of a telehealth counselling intervention consisting of twelve 20-30 min weekly sessions focused on identifying and problem-solving around barriers to HIV care access and adherence and on addressing mental health, substance use and/or other issues. Participants also receive text messages for check-ins, appointment reminders and to improve engagement. Participants complete quantitative online surveys at baseline, 4 and 8 months and qualitative exit interviews. Clinical outcomes, including plasma HIV RNA and CD4+ cell count, are collected from medical records. Study staff will explore outcomes of the intervention using quantitative and qualitative methods. ETHICS AND DISSEMINATION This study and its protocols have been approved by the University of California, San Francisco (UCSF) Institutional Review Board. Study staff will work with the UCSF Center for AIDS Prevention Studies' Community Engagement Core and the Youth Advisory Panel to disseminate results to the community, participants and the academic community. TRIAL REGISTRATION NCT03681145.",2019,(YLWH) experience worse clinical outcomes than adults and high rates of behavioural health challenges that impact their engagement in care and adherence to antiretroviral therapy.,"['Youth and young adults living with HIV', 'youth living with HIV']",['Telehealth and texting intervention'],['plasma HIV RNA and CD4+ cell\u2009count'],"[{'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}]","[{'cui': 'C1328956', 'cui_str': 'eHealth'}, {'cui': 'C3178908', 'cui_str': 'Texting'}]","[{'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0035668', 'cui_str': 'RNA'}, {'cui': 'C0243009', 'cui_str': 'CD4+ Counts'}]",,0.084734,(YLWH) experience worse clinical outcomes than adults and high rates of behavioural health challenges that impact their engagement in care and adherence to antiretroviral therapy.,"[{'ForeName': 'Angie R', 'Initials': 'AR', 'LastName': 'Wootton', 'Affiliation': 'Department of Medicine, Center for AIDS Prevention Studies, University of California, San Francisco, San Francisco, California, USA.'}, {'ForeName': 'Dominique A', 'Initials': 'DA', 'LastName': 'Legnitto', 'Affiliation': 'Department of Medicine, Center for AIDS Prevention Studies, University of California, San Francisco, San Francisco, California, USA.'}, {'ForeName': 'Valerie A', 'Initials': 'VA', 'LastName': 'Gruber', 'Affiliation': 'Department of Psychiatry, University of California, San Francisco, San Francisco, USA.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Dawson-Rose', 'Affiliation': 'School of Nursing, Department of Community Health Systems, University of California, San Francisco, San Francisco, California, USA.'}, {'ForeName': 'Torsten B', 'Initials': 'TB', 'LastName': 'Neilands', 'Affiliation': 'Department of Medicine, Center for AIDS Prevention Studies, University of California, San Francisco, San Francisco, California, USA.'}, {'ForeName': 'Mallory O', 'Initials': 'MO', 'LastName': 'Johnson', 'Affiliation': 'Department of Medicine, Center for AIDS Prevention Studies, University of California, San Francisco, San Francisco, California, USA.'}, {'ForeName': 'Parya', 'Initials': 'P', 'LastName': 'Saberi', 'Affiliation': 'Department of Medicine, Center for AIDS Prevention Studies, University of California, San Francisco, San Francisco, California, USA.'}]",BMJ open,['10.1136/bmjopen-2018-028522'] 700,31791405,"Improving risk perception and uptake of pre-exposure prophylaxis (PrEP) through interactive feedback-based counselling with and without community engagement in young women in Manicaland, East Zimbabwe: study protocol for a pilot randomized trial.","BACKGROUND HIV incidence in adolescent girls and young women remains high in sub-Saharan Africa. Progress towards uptake of HIV prevention methods remains low. Studies of oral pre-exposure prophylaxis (PrEP) have shown that uptake and adherence may be low due to low-risk perception and ambivalence around using antiretrovirals for prevention. No evidence exists on whether an interactive intervention aimed at adjusting risk perception and addressing the uncertainty around PrEP will improve uptake. This pilot research trial aims to provide an initial evaluation of the impact of an interactive digital tablet-based counselling session, correcting risk perception, and addressing ambiguity around availability, usability, and effectiveness of PrEP. METHODS/DESIGN This is a matched-cluster randomized controlled trial which will compare an interactive tablet-based education intervention against a control with no intervention. The study will be implemented in eight sites. In each site, two matched clusters of villages will be created. One cluster will be randomly allocated to intervention. In two sites, a community engagement intervention will also be implemented to address social obstacles and to increase support from peers, families, and social structures. A total of 1200 HIV-negative young women aged 18-24 years, not on PrEP at baseline, will be eligible. Baseline measures of endpoints will be gathered in surveys. Follow-up assessment at six months will include biomarkers of PrEP uptake and surveys. DISCUSSION This will be the first randomized controlled trial to determine whether interactive feedback counselling leads to uptake of HIV prevention methods such as PrEP and reduces risky sexual behavior. If successful, policymakers could consider such an intervention in school-based education campaigns or as post-HIV-testing counselling for young people. TRIAL REGISTRATION Clinicaltrials.gov, NCT03565575. Registered on 21 June 2018.",2019,This is a matched-cluster randomized controlled trial which will compare an interactive tablet-based education intervention against a control with no intervention.,"['young women in Manicaland, East Zimbabwe', '1200 HIV-negative young women aged 18-24\u2009years, not on PrEP at baseline, will be eligible', 'adolescent girls and young women remains high in sub-Saharan Africa']","['pre-exposure prophylaxis (PrEP) through interactive feedback-based counselling with and without community engagement', 'oral pre-exposure prophylaxis (PrEP', 'interactive digital tablet-based counselling session', 'interactive tablet-based education intervention', 'interactive feedback counselling']",['risky sexual behavior'],"[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0043476', 'cui_str': 'Southern Rhodesia'}, {'cui': 'C4517548', 'cui_str': 'One thousand two hundred'}, {'cui': 'C0481430', 'cui_str': 'HTLV-3 antibody negative'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0001738', 'cui_str': 'Subsaharan Africa'}]","[{'cui': 'C3850098', 'cui_str': 'Pre-Exposure Prophylaxis (PrEP)'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray (qualifier value)'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0036864', 'cui_str': 'Sexual Behavior'}]",1200.0,0.205144,This is a matched-cluster randomized controlled trial which will compare an interactive tablet-based education intervention against a control with no intervention.,"[{'ForeName': 'Ranjeeta', 'Initials': 'R', 'LastName': 'Thomas', 'Affiliation': 'Department of Health Policy, London School of Economics and Political Science, Cowdray House, London, WC2 2AE, UK. r.a.thomas@lse.ac.uk.'}, {'ForeName': 'Morten', 'Initials': 'M', 'LastName': 'Skovdal', 'Affiliation': 'Section of Health Services Research, Department of Public Health, University of Copenhagen, Øster Farimagsgade 5 opg. B, Postb, 15, Building: 15.0.17, 1014, København K, Denmark.'}, {'ForeName': 'Matteo M', 'Initials': 'MM', 'LastName': 'Galizzi', 'Affiliation': 'Department of Psychological and Behavioural Science, London School of Economics and Political Science, London, WC2 2AE, UK.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Schaefer', 'Affiliation': ""Department of Infectious Disease Epidemiology, Imperial College London, St Mary's Campus Norfolk Place, London, W2 1PG, UK.""}, {'ForeName': 'Louisa', 'Initials': 'L', 'LastName': 'Moorhouse', 'Affiliation': ""Department of Infectious Disease Epidemiology, Imperial College London, St Mary's Campus Norfolk Place, London, W2 1PG, UK.""}, {'ForeName': 'Constance', 'Initials': 'C', 'LastName': 'Nyamukapa', 'Affiliation': ""Department of Infectious Disease Epidemiology, Imperial College London, St Mary's Campus Norfolk Place, London, W2 1PG, UK.""}, {'ForeName': 'Rufurwokuda', 'Initials': 'R', 'LastName': 'Maswera', 'Affiliation': 'Biomedical Research and Training Institute, 10 Seagrave, Avondale, Harare, Zimbabwe.'}, {'ForeName': 'Phyllis', 'Initials': 'P', 'LastName': 'Mandizvidza', 'Affiliation': 'Biomedical Research and Training Institute, 10 Seagrave, Avondale, Harare, Zimbabwe.'}, {'ForeName': 'Timothy B', 'Initials': 'TB', 'LastName': 'Hallett', 'Affiliation': ""Department of Infectious Disease Epidemiology, Imperial College London, St Mary's Campus Norfolk Place, London, W2 1PG, UK.""}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Gregson', 'Affiliation': ""Department of Infectious Disease Epidemiology, Imperial College London, St Mary's Campus Norfolk Place, London, W2 1PG, UK.""}]",Trials,['10.1186/s13063-019-3791-8'] 701,31659411,Implementation of a Surgical Simulation Care Pathway Approach to Training in Emergency Abdominal Surgery.,"BACKGROUND Simulation-based care pathway approach (CPA) training is a novel approach in surgical education. The objective of the present study was to determine whether CPA was feasible for training surgical residents and could improve efficiency in patients' management. A common disease was chosen: acute appendicitis. METHODS All five junior residents of our department were trained in CPA: preoperative CPA consisted in virtual patients (VPs) presenting with acute right iliac fossa pain; intraoperative CPA involved a virtual competency-based curriculum for laparoscopic appendectomy (LAPP); finally, post-operative VP were reviewed after LAPP. Thirty-eight patients undergoing appendectomy were prospectively included before (n = 21) and after (n = 17) the training. All demographic and perioperative data were prospectively collected from their medical records, and time taken from admission to management was measured. RESULTS All residents had performed less than 10 LAPP as primary operator. Pre- and intraoperative data were comparable between pretraining and post-training patients. Times to liquid and solid diet were significantly reduced after training [7 h (2-20) vs. 4 (4-6); P = 0.004, and 17 h (4-48) vs. 6 (4-24); P = 0.005] without changing post-operative morbidity [4 (19%) vs. 0 (0); P = 0.11] and length of stay [48 h (30-264) vs. 44 (21-145); P = 0.22]. CONCLUSIONS CPA training is feasible in abdominal surgery. In the current study, it improved patients' management in terms of earlier oral intake.",2020,"All five junior residents of our department were trained in CPA: preoperative CPA consisted in virtual patients (VPs) presenting with acute right iliac fossa pain; intraoperative CPA involved a virtual competency-based curriculum for laparoscopic appendectomy (LAPP); finally, post-operative VP were reviewed after LAPP.","['Thirty-eight patients undergoing appendectomy were prospectively included before (n\u2009=\u200921) and after (n\u2009=\u200917) the training', 'All five junior residents of our department were trained in', 'Emergency Abdominal Surgery', ""patients' management""]","['Simulation-based care pathway approach (CPA) training', 'CPA', 'CPA training', 'CPA: preoperative CPA consisted in virtual patients (VPs) presenting with acute right iliac fossa pain; intraoperative CPA involved a virtual competency-based curriculum for laparoscopic appendectomy (LAPP']","['Pre- and intraoperative data', 'operative morbidity', 'length of stay', 'Times to liquid and solid diet']","[{'cui': 'C0450361', 'cui_str': '38 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0003611', 'cui_str': 'Appendectomy'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0175673', 'cui_str': 'Emergency (qualifier value)'}, {'cui': 'C0000726', 'cui_str': 'Abdomen'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0476306', 'cui_str': 'Right iliac fossa pain (finding)'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C0220815', 'cui_str': 'curriculum'}, {'cui': 'C0372525', 'cui_str': 'Endoscopic appendectomy'}, {'cui': 'C0337904', 'cui_str': 'Lapps (ethnic group)'}]","[{'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1304698', 'cui_str': 'Liquid - descriptor'}, {'cui': 'C0302909', 'cui_str': 'Solid substance (substance)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}]",38.0,0.0240625,"All five junior residents of our department were trained in CPA: preoperative CPA consisted in virtual patients (VPs) presenting with acute right iliac fossa pain; intraoperative CPA involved a virtual competency-based curriculum for laparoscopic appendectomy (LAPP); finally, post-operative VP were reviewed after LAPP.","[{'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Beyer-Berjot', 'Affiliation': ""Department of Surgery and Cancer, St. Mary's Campus, Imperial College Healthcare NHS Trust, London, UK. laura.beyer@ap-hm.fr.""}, {'ForeName': 'Vishal', 'Initials': 'V', 'LastName': 'Patel', 'Affiliation': ""Department of Surgery and Cancer, St. Mary's Campus, Imperial College Healthcare NHS Trust, London, UK.""}, {'ForeName': 'Pramudith', 'Initials': 'P', 'LastName': 'Sirimanna', 'Affiliation': ""Department of Surgery and Cancer, St. Mary's Campus, Imperial College Healthcare NHS Trust, London, UK.""}, {'ForeName': 'Daniel A', 'Initials': 'DA', 'LastName': 'Hashimoto', 'Affiliation': 'Department of Surgery, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Berdah', 'Affiliation': 'Centre for Surgical Teaching and Research (CERC), Faculté de Médecine Secteur Nord, Aix-Marseille University, 51 Boulevard Pierre Dramard, 13015, Marseille, France.'}, {'ForeName': 'Ara', 'Initials': 'A', 'LastName': 'Darzi', 'Affiliation': ""Department of Surgery and Cancer, St. Mary's Campus, Imperial College Healthcare NHS Trust, London, UK.""}, {'ForeName': 'Rajesh', 'Initials': 'R', 'LastName': 'Aggarwal', 'Affiliation': ""Department of Surgery and Cancer, St. Mary's Campus, Imperial College Healthcare NHS Trust, London, UK.""}]",World journal of surgery,['10.1007/s00268-019-05242-1'] 702,31196113,"Study protocol: E-freeze - freezing of embryos in assisted conception: a randomised controlled trial evaluating the clinical and cost effectiveness of a policy of freezing embryos followed by thawed frozen embryo transfer compared with a policy of fresh embryo transfer, in women undergoing in vitro fertilisation.","BACKGROUND Infertility affects one in seven couples; many of these need in vitro fertilisation (IVF). IVF involves external hormones to stimulate a woman's ovaries to produce eggs which are harvested surgically. Embryos, created in the laboratory by mixing eggs with sperm, are grown in culture for a few days before being replaced within the uterus (fresh embryo transfer). Spare embryos are usually frozen with a view to transfer at a later point in time - especially if the initial fresh transfer does not result in a pregnancy. Despite improvements in technology, IVF success rates remain low with an overall live birth rate of 25-30% per treatment. Additionally, there are concerns about health outcomes for mothers and babies conceived through IVF, particularly after fresh embryo transfer, including maternal ovarian hyperstimulation syndrome (OHSS) and preterm delivery. It is believed that high levels of hormones during ovarian stimulation could create a relatively hostile environment for embryo implantation whilst increasing the risk of OHSS. It has been suggested that freezing all embryos with the intention of thawing and replacing them within the uterus at a later stage (thawed frozen embryo transfer) instead of fresh embryo transfer, may lead to improved pregnancy rates and fewer complications. We aim to compare the clinical and cost effectiveness of fresh and thawed frozen embryo transfer, with the primary aim of identifying any difference in the chance of having a healthy baby. METHODS E-Freeze is a pragmatic, multicentre two-arm parallel group randomised controlled trial where women aged ≥18 and < 42 years, with at least three good quality embryos are randomly allocated to receive either a fresh or thawed frozen embryo transfer. The primary outcome is a healthy baby, defined as a term, singleton, live birth with appropriate weight for gestation. Cost effectiveness will be calculated from a healthcare and societal perspective. DISCUSSION E-Freeze will determine the relative benefits of fresh and thawed frozen embryo transfer in terms of improving the chance of having a healthy baby. The results of this pragmatic study have the potential to be directly transferred to clinical practice. TRIAL REGISTRATION ISRCTN registry: ISRCTN61225414 . Date assigned 29/12/2015.",2019,"Despite improvements in technology, IVF success rates remain low with an overall live birth rate of 25-30% per treatment.","['women aged ≥18 and\u2009<\u200942\u2009years, with at least three good quality embryos', 'women undergoing in vitro fertilisation']","['E-freeze - freezing of embryos in assisted conception', 'fresh or thawed frozen embryo transfer', 'policy of freezing embryos followed by thawed frozen embryo transfer compared with a policy of fresh embryo transfer', 'fresh and thawed frozen embryo transfer', 'IVF']","['pregnancy rates', 'Cost effectiveness', 'healthy baby, defined as a term, singleton, live birth with appropriate weight for gestation', 'maternal ovarian hyperstimulation syndrome (OHSS) and preterm delivery']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0013935', 'cui_str': 'Embryo'}, {'cui': 'C0015915', 'cui_str': 'Test-Tube Fertilization'}]","[{'cui': 'C0677542', 'cui_str': 'Frozen (qualifier value)'}, {'cui': 'C0013935', 'cui_str': 'Embryo'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0009637', 'cui_str': 'Conception'}, {'cui': 'C0443224', 'cui_str': 'Fresh (qualifier value)'}, {'cui': 'C0404110', 'cui_str': 'Frozen embryo transfer (procedure)'}, {'cui': 'C0242456', 'cui_str': 'Policy'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0440732', 'cui_str': 'Fresh embryo (substance)'}, {'cui': 'C0040671', 'cui_str': 'Transfer'}, {'cui': 'C0015915', 'cui_str': 'Test-Tube Fertilization'}]","[{'cui': 'C0032975', 'cui_str': 'Pregnancy Rate'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0481667', 'cui_str': 'Live Birth'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0085083', 'cui_str': 'Ovarian Hyperstimulation Syndrome'}, {'cui': 'C0151526', 'cui_str': 'Premature Birth'}]",,0.173751,"Despite improvements in technology, IVF success rates remain low with an overall live birth rate of 25-30% per treatment.","[{'ForeName': 'Abha', 'Initials': 'A', 'LastName': 'Maheshwari', 'Affiliation': 'University of Aberdeen, Aberdeen, UK. abha.maheshwari@abdn.ac.uk.'}, {'ForeName': 'Siladitya', 'Initials': 'S', 'LastName': 'Bhattacharya', 'Affiliation': 'University of Cardiff, Cardiff, UK.'}, {'ForeName': 'Ursula', 'Initials': 'U', 'LastName': 'Bowler', 'Affiliation': 'University of Oxford, Oxford, UK.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Brison', 'Affiliation': ""St. Mary's Hospital, Manchester, UK.""}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Child', 'Affiliation': 'University of Oxford, Oxford, UK.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Cole', 'Affiliation': 'University of Oxford, Oxford, UK.'}, {'ForeName': 'Arri', 'Initials': 'A', 'LastName': 'Coomarasamy', 'Affiliation': ""Birmingham Women's Hospital, Birmingham, UK.""}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Cutting', 'Affiliation': 'Jessop Wing Maternity Unit, Sheffield, UK.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Harbottle', 'Affiliation': 'IVF Cambridge, Cambridge, UK.'}, {'ForeName': 'Pollyanna', 'Initials': 'P', 'LastName': 'Hardy', 'Affiliation': 'University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Edmund', 'Initials': 'E', 'LastName': 'Juszczak', 'Affiliation': 'University of Oxford, Oxford, UK.'}, {'ForeName': 'Yacoub', 'Initials': 'Y', 'LastName': 'Khalaf', 'Affiliation': ""Guy's and St. Thomas' Hospital, London, UK.""}, {'ForeName': 'Jennifer J', 'Initials': 'JJ', 'LastName': 'Kurinczuk', 'Affiliation': 'University of Oxford, Oxford, UK.'}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'Lavery', 'Affiliation': 'IVF Hammersmith, London, UK.'}, {'ForeName': 'Clare', 'Initials': 'C', 'LastName': 'Lewis-Jones', 'Affiliation': 'Formerly Fertility Network, London, UK.'}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Macklon', 'Affiliation': ""London Women's Clinic Group, London, UK.""}, {'ForeName': 'Nick J', 'Initials': 'NJ', 'LastName': 'Raine-Fenning', 'Affiliation': 'University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Madhurima', 'Initials': 'M', 'LastName': 'Rajkohwa', 'Affiliation': 'Care Fertility, Birmingham, UK.'}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'Scotland', 'Affiliation': 'University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Troup', 'Affiliation': 'Reproductive Health, Manchester, UK.'}]",Reproductive health,['10.1186/s12978-019-0737-2'] 703,30817019,Willing to Work But Not to Wait: Individuals with Greater Alcohol Use Disorder Show Increased Delay Discounting Across Commodities and Less Effort Discounting for Alcohol.,"BACKGROUND Delay discounting refers to the devaluation of a reward given increasing delays to delivery. Similarly, effort discounting refers to the devaluation of a reward given increasing effort required to obtain it. Individuals with substance use disorder show higher rates of delay discounting, exacerbating short-term positive reinforcement at the expense of long-term consequences. This study explores how effort discounting compares to delay discounting behavior among alcohol users as well as how these preferences change between monetary and alcohol rewards. METHODS A total of 100 participants completed an online survey through Amazon Mechanical Turk. Participant alcohol use was evaluated using DSM-5 and the Alcohol Use Disorders Identification Test criteria. All participants completed 4 randomized discounting tasks involving delay or effort discounting, in which the reward was money or alcohol. A follow-up experiment (n = 423) added the alcohol purchase task to assess alcohol valuation. RESULTS Individuals with greater alcohol use disorder (AUD) severity discounted future money and alcohol significantly more than those with less AUD. However, individuals meeting more DSM-5 criteria were only willing to perform more effort for alcohol. The follow-up experiment replicated these findings and demonstrated that individuals with greater AUD also showed an increased valuation of alcohol and alcohol value-mediated effort discounting. CONCLUSIONS These results suggest that individuals with greater AUD were less willing to wait for money or alcohol. While all participants were willing to work for money regardless of AUD severity, individuals with greater AUD showed increased valuation of alcohol drinks and were willing to exert more effort to obtain alcohol. Together, these results paint a picture of individuals with increased AUD as both more impulsive and willing to work to obtain alcohol, contributing to our understanding of decision making among individuals who abuse substances.",2019,"While all participants were willing to work for money regardless of AUD severity, individuals with greater AUD showed increased valuation of alcohol drinks and were willing to exert more effort to obtain alcohol.","['Individuals with substance use disorder', 'individuals who abuse substances', 'Individuals with greater alcohol use disorder (AUD', '100 participants completed an online survey through Amazon Mechanical Turk', 'Individuals with Greater Alcohol Use Disorder Show']","['alcohol purchase task to assess alcohol valuation', 'randomized discounting tasks involving delay or effort discounting, in which the reward was money or alcohol']","['valuation of alcohol drinks', 'valuation of alcohol and alcohol value-mediated effort discounting', 'rates of delay discounting, exacerbating short-term positive reinforcement']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0038586', 'cui_str': 'Substance Use Disorders'}, {'cui': 'C1546935', 'cui_str': 'Abuse (event)'}, {'cui': 'C0439861', 'cui_str': 'Substance (substance)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0001956', 'cui_str': 'Alcohol Use Disorder'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0443254', 'cui_str': 'Mechanical (qualifier value)'}, {'cui': 'C0337911', 'cui_str': 'Turks (ethnic group)'}]","[{'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C0035397', 'cui_str': 'Rewards'}]","[{'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0452428', 'cui_str': 'Drinks (substance)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}, {'cui': 'C3850035', 'cui_str': 'Intertemporal Decision Making'}, {'cui': 'C1444749', 'cui_str': 'Exacerbated (qualifier value)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0032741', 'cui_str': 'Positive Reinforcement'}]",100.0,0.0143048,"While all participants were willing to work for money regardless of AUD severity, individuals with greater AUD showed increased valuation of alcohol drinks and were willing to exert more effort to obtain alcohol.","[{'ForeName': 'Quan H', 'Initials': 'QH', 'LastName': 'Phung', 'Affiliation': 'Virginia Tech Carilion School of Medicine, Roanoke, Virginia.'}, {'ForeName': 'Sarah E', 'Initials': 'SE', 'LastName': 'Snider', 'Affiliation': 'Addiction Recovery Research Center, Fralin Biomedical Research Institute at VTC, Roanoke, Virginia.'}, {'ForeName': 'Allison N', 'Initials': 'AN', 'LastName': 'Tegge', 'Affiliation': 'Virginia Tech Carilion School of Medicine, Roanoke, Virginia.'}, {'ForeName': 'Warren K', 'Initials': 'WK', 'LastName': 'Bickel', 'Affiliation': 'Addiction Recovery Research Center, Fralin Biomedical Research Institute at VTC, Roanoke, Virginia.'}]","Alcoholism, clinical and experimental research",['10.1111/acer.13996'] 704,30790145,Pharmacotherapy of Postpartum Depression: Current Approaches and Novel Drug Development.,"Postpartum depression is one of the most common complications of childbirth. Untreated postpartum depression can have substantial adverse effects on the well-being of the mother and child, negatively impacting child cognitive, behavioral, and emotional development with lasting consequences. There are a number of therapeutic interventions for postpartum depression including pharmacotherapy, psychotherapy, neuromodulation, and hormonal therapy among others, most of which have been adapted from the treatment of major depressive disorder outside of the peripartum period. Current evidence of antidepressant treatment for postpartum depression is limited by the small number of randomized clinical trials, underpowered samples, and the lack of long-term follow-up. The peripartum period is characterized by rapid and significant physiological change in plasma levels of endocrine hormones, peptides, and neuroactive steroids. Evidence supporting the role of neuroactive steroids and γ-aminobutyric acid (GABA) in the pathophysiology of postpartum depression led to the investigation of synthetic neuroactive steroids and their analogs as potential treatment for postpartum depression. Brexanolone, a soluble proprietary intravenous preparation of synthetic allopregnanolone, has been developed. A recent series of open-label and placebo-controlled randomized clinical trials of brexanolone in postpartum depression demonstrated a rapid reduction in depressive symptoms, and has led to the submission for regulatory approval to the US Food and Drug Administration (decision due in March 2019). SAGE-217, an allopregnanolone analog, with oral bioavailability, was recently tested in a randomized, double-blind, placebo-controlled phase III study in severe postpartum depression, with reportedly positive results. Finally, a 3β-methylated synthetic analog of allopregnanolone, ganaxolone, is being tested in both intravenous and oral forms, in randomized, double-blind, placebo-controlled phase II studies in severe postpartum depression.",2019,"Untreated postpartum depression can have substantial adverse effects on the well-being of the mother and child, negatively impacting child cognitive, behavioral, and emotional development with lasting consequences.",[],"['neuroactive steroids and γ-aminobutyric acid (GABA', 'placebo', 'allopregnanolone, ganaxolone', 'brexanolone', 'Brexanolone']",[],[],"[{'cui': 'C0038317', 'cui_str': 'Steroids'}, {'cui': 'C0220780', 'cui_str': 'Aminobutyric Acid'}, {'cui': 'C0016904', 'cui_str': 'gamma-Aminobutyric Acid'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0376202', 'cui_str': 'Allopregnanolone'}, {'cui': 'C0537150', 'cui_str': 'ganaxolone'}, {'cui': 'C4548848', 'cui_str': 'brexanolone'}]",[],,0.279329,"Untreated postpartum depression can have substantial adverse effects on the well-being of the mother and child, negatively impacting child cognitive, behavioral, and emotional development with lasting consequences.","[{'ForeName': 'Ariela', 'Initials': 'A', 'LastName': 'Frieder', 'Affiliation': ""Department of Psychiatry, Women's Behavioral Health, Zucker Hillside Hospital, Northwell Health, 75-59 263rd Street, New York, NY, 11004, USA.""}, {'ForeName': 'Madeleine', 'Initials': 'M', 'LastName': 'Fersh', 'Affiliation': ""Department of Psychiatry, Women's Behavioral Health, Zucker Hillside Hospital, Northwell Health, 75-59 263rd Street, New York, NY, 11004, USA.""}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Hainline', 'Affiliation': 'Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Hempstead, NY, USA.'}, {'ForeName': 'Kristina M', 'Initials': 'KM', 'LastName': 'Deligiannidis', 'Affiliation': ""Department of Psychiatry, Women's Behavioral Health, Zucker Hillside Hospital, Northwell Health, 75-59 263rd Street, New York, NY, 11004, USA. kdeligian1@northwell.edu.""}]",CNS drugs,['10.1007/s40263-019-00605-7'] 705,30807822,Higher Reported Lung Dose Received During Total Body Irradiation for Allogeneic Hematopoietic Stem Cell Transplantation in Children With Acute Lymphoblastic Leukemia Is Associated With Inferior Survival: A Report from the Children's Oncology Group.,"PURPOSE To examine the relationship between lung radiation dose and survival outcomes in children undergoing total body irradiation (TBI)-based hematopoietic stem cell transplantation (HSCT) for acute lymphoblastic leukemia on the Children's Oncology Group trial. METHODS AND MATERIALS TBI (1200 or 1320 cGy given twice daily in 6 or 8 fractions) was used as part of 3 HSCT preparative regimens, allowing institutional flexibility regarding TBI techniques, including lung shielding. Lung doses as reported by each participating institution were calculated for different patient setups, with and without shielding, with a variety of dose calculation techniques. The association between lung dose and transplant-related mortality, relapse-free survival, and overall survival (OS) was examined using the Cox proportional hazards regression model controlling for the following variables: TBI dose rate, TBI fields, patient position during TBI, donor type, and pre-HSCT minimal residual disease level. RESULTS Of a total of 143 eligible patients, 127 had lung doses available for this analysis. The TBI techniques were heterogeneous. The mean lung dose was reported as 904.5 cGy (standard deviation, ±232.3). Patients treated with lateral fields were more likely to receive lung doses ≥800 cGy (P < .001). The influence of lung dose ≥800 cGy on transplant-related mortality was not significant (hazard ratio [HR], 1.78; P = .21). On univariate analysis, lung dose ≥800 cGy was associated with inferior relapse-free survival (HR, 1.76; P = .04) and OS (HR, 1.85; P = .03). In the multivariate analysis, OS maintained statistical significance (HR, 1.85; P = .04). CONCLUSIONS The variability in TBI techniques resulted in uncertainty with reported lung doses. Lateral fields were associated with higher lung dose, and thus they should be avoided. Patients treated with lung dose <800 cGy in this study had better outcomes. This approach is currently being investigated in the Children's Oncology Group AALL1331 study. Additionally, the Imaging and Radiation Oncology Core Group is evaluating effects of TBI techniques on lung doses using a phantom.",2019,Patients treated with lateral fields were more likely to receive lung doses ≥800 cGy ,"['Children With Acute Lymphoblastic Leukemia', 'children undergoing', 'Of a total of 143 eligible patients, 127 had lung doses available for this analysis', 'TBI (1200 or 1320\xa0cGy given twice daily in 6 or 8 fractions']","['Allogeneic Hematopoietic Stem Cell Transplantation', 'total body irradiation (TBI)-based hematopoietic stem cell transplantation (HSCT']","['mean lung dose', 'inferior relapse-free survival', 'transplant-related mortality', 'Inferior Survival', 'lung dose and transplant-related mortality, relapse-free survival, and overall survival (OS']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1961102', 'cui_str': 'Lymphocytic Leukemia, Acute'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4517573', 'cui_str': 'One hundred and forty-three'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0024109', 'cui_str': 'Lung'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C4517548', 'cui_str': 'One thousand two hundred'}, {'cui': 'C0556645', 'cui_str': 'cGy'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}, {'cui': 'C1264633', 'cui_str': 'Fractions of (qualifier value)'}]","[{'cui': 'C0472699', 'cui_str': 'Hematopoietic Stem Cell Transplantation'}, {'cui': 'C0043162', 'cui_str': 'Radiation, Whole-Body'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0024109', 'cui_str': 'Lung'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0542339', 'cui_str': 'Below (qualifier value)'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0332835', 'cui_str': 'Grafts'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",143.0,0.0293656,Patients treated with lateral fields were more likely to receive lung doses ≥800 cGy ,"[{'ForeName': 'Natia', 'Initials': 'N', 'LastName': 'Esiashvili', 'Affiliation': 'Emory University Winship Cancer Institute, Atlanta, Georgia. Electronic address: nesiash@emory.edu.'}, {'ForeName': 'Xiaomin', 'Initials': 'X', 'LastName': 'Lu', 'Affiliation': ""Children's Oncology Group Data Center, Biostatistics, University of Florida, Gainesville, Florida.""}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Ulin', 'Affiliation': 'Imaging and Radiation Oncology Rhode Island QA Center, Lincoln, Rhode Island.'}, {'ForeName': 'Fran', 'Initials': 'F', 'LastName': 'Laurie', 'Affiliation': 'Imaging and Radiation Oncology Rhode Island QA Center, Lincoln, Rhode Island.'}, {'ForeName': 'Sandy', 'Initials': 'S', 'LastName': 'Kessel', 'Affiliation': 'Imaging and Radiation Oncology Rhode Island QA Center, Lincoln, Rhode Island.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Kalapurakal', 'Affiliation': 'Robert H. Lurie Comprehensive Cancer Center of Northwestern University, Chicago, Illinois.'}, {'ForeName': 'Thomas E', 'Initials': 'TE', 'LastName': 'Merchant', 'Affiliation': ""St Jude Children's Research Hospital, Memphis, Tennessee.""}, {'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Followill', 'Affiliation': 'Imaging and Radiation Oncology Rhode Island QA Center, Houston, Texas.'}, {'ForeName': 'Vythialinga', 'Initials': 'V', 'LastName': 'Sathiaseelan', 'Affiliation': 'Robert H. Lurie Comprehensive Cancer Center of Northwestern University, Chicago, Illinois.'}, {'ForeName': 'Mary K', 'Initials': 'MK', 'LastName': 'Schmitter', 'Affiliation': 'Imaging and Radiation Oncology Rhode Island QA Center, Lincoln, Rhode Island.'}, {'ForeName': 'Meenakshi', 'Initials': 'M', 'LastName': 'Devidas', 'Affiliation': ""Children's Oncology Group Data Center, Biostatistics, University of Florida, Gainesville, Florida.""}, {'ForeName': 'Yichen', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': ""Children's Oncology Group Data Center, Biostatistics, University of Florida, Gainesville, Florida.""}, {'ForeName': 'Donna A', 'Initials': 'DA', 'LastName': 'Wall', 'Affiliation': 'Manitoba Blood and Marrow Transplant Program, Winnipeg, Manitoba, Canada.'}, {'ForeName': 'Patrick A', 'Initials': 'PA', 'LastName': 'Brown', 'Affiliation': 'Johns Hopkins University Kimmel Cancer Center, Baltimore, Maryland.'}, {'ForeName': 'Stephen P', 'Initials': 'SP', 'LastName': 'Hunger', 'Affiliation': ""Children's Hospital of Philadelphia and the Perelman School of Medicine at The University of Pennsylvania, Philadelphia, Pennsylvania.""}, {'ForeName': 'Stephan A', 'Initials': 'SA', 'LastName': 'Grupp', 'Affiliation': ""Children's Hospital of Philadelphia and the Perelman School of Medicine at The University of Pennsylvania, Philadelphia, Pennsylvania.""}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Pulsipher', 'Affiliation': ""Children's Center for Cancer and Blood Diseases, Children's Hospital Los Angeles, University of Southern California Keck School of Medicine, Los Angeles, California.""}]","International journal of radiation oncology, biology, physics",['10.1016/j.ijrobp.2019.02.034'] 706,31041855,"Blonanserin versus haloperidol in Japanese patients with schizophrenia: A phase 3, 8-week, double-blind, multicenter, randomized controlled study.","OBJECTIVE This Japanese, multicenter, randomized, double-blind trial, evaluating the efficacy and safety of blonanserin compared with haloperidol in patients with schizophrenia, was previously published by Murasaki in the Japanese language. In this article, we present the results of the trial based on full analysis dataset instead of per protocol dataset formerly reported and discuss the findings in light of the latest knowledge of pharmacological treatment for schizophrenia. METHODS A total of 265 patients were randomized to receive blonanserin (8 to 24 mg/d) or haloperidol (4 to 12 mg/d) twice daily for 8 weeks. Efficacy assessments included the Clinical Global Impressions-Improvement (CGI-I) and the Positive and Negative Syndrome Scale (PANSS). RESULTS Blonanserin was not inferior to haloperidol with a margin of 10% with respect to the improvement rate on CGI-I at end of study (60.5% vs 50.0%, P < 0.001). The decrease in the PANSS total score did not differ between the drugs (-10.3 vs -7.1). For the PANSS negative symptom score, the decrease was significantly greater with blonanserin than with haloperidol (P = 0.006). Blonanserin was well tolerated. The incidence of adverse events was similar for the two drugs. Extrapyramidal adverse events, sedation, hypotension, and prolactin increase were rarer with blonanserin than with haloperidol. No clinically important weight gain was observed. CONCLUSIONS Blonanserin is as effective as haloperidol for the treatment of schizophrenia. Blonanserin is more effective for negative symptoms with a lower risk of extrapyramidal symptoms compared with haloperidol.",2019,"For the PANSS negative symptom score, the decrease was significantly greater with blonanserin than with haloperidol (P = 0.006).","['patients with schizophrenia, was previously published by Murasaki in the Japanese language', 'A total of 265 patients', 'Japanese patients with schizophrenia']","['blonanserin', 'haloperidol', 'Blonanserin']","['PANSS negative symptom score', 'tolerated', 'Extrapyramidal adverse events, sedation, hypotension, and prolactin increase', 'improvement rate on CGI', 'adverse events', 'Clinical Global Impressions-Improvement (CGI-I) and the Positive and Negative Syndrome Scale (PANSS', 'PANSS total score', 'weight gain', 'efficacy and safety']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C0376247', 'cui_str': 'Japanese language (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1556094', 'cui_str': 'Japanese'}]","[{'cui': 'C0287983', 'cui_str': 'blonanserin'}, {'cui': 'C0018546', 'cui_str': 'Haloperidol'}]","[{'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0020649', 'cui_str': 'Blood Pressure, Low'}, {'cui': 'C0553731', 'cui_str': 'PRL increased'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0451383', 'cui_str': 'Positive and negative syndrome scale (assessment scale)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0043094', 'cui_str': 'Weight Gain'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",265.0,0.0568068,"For the PANSS negative symptom score, the decrease was significantly greater with blonanserin than with haloperidol (P = 0.006).","[{'ForeName': 'Philip D', 'Initials': 'PD', 'LastName': 'Harvey', 'Affiliation': 'Leonard M. Miller Professor of Psychiatry and Behavioral Sciences, University of Miami Miller School of Medicine, Miami, Florida.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Nakamura', 'Affiliation': 'Medical Affairs, Sumitomo Dainippon Pharma Co., Ltd, Tokyo, Japan.'}, {'ForeName': 'Mitsukuni', 'Initials': 'M', 'LastName': 'Murasaki', 'Affiliation': 'Institute of CNS Pharmacology, Kanagawa, Japan.'}]",Neuropsychopharmacology reports,['10.1002/npr2.12057'] 707,30938860,Effects of supplemental calcium and vitamin D on tight-junction proteins and mucin-12 expression in the normal rectal mucosa of colorectal adenoma patients.,"The physical gut barrier, comprised of a thick mucus layer and the epithelium, plays an important role in defense against microbes and foreign antigens. Calcium and vitamin D may be involved in maintaining the integrity of the intestinal mucosal barrier, the dysfunction of which may lead to endotoxemia and inflammation, and contribute to colorectal carcinogenesis. We investigated supplemental calcium (1200 mg, daily) and/or vitamin D 3 (1000 IU daily) effects on intestinal barrier function-related biomarkers in a subset of 105 participants from a large colorectal adenoma recurrence chemoprevention clinical trial. We assessed expression of the tight junction proteins claudin-1 (CLDN1), occludin (OCLD), and mucin-12 (MUC12) in the normal-appearing colorectal mucosa using standardized, automated immunohistochemistry and quantitative image analysis. Following 1 year of treatment, in the calcium relative to the no calcium group, the CLDN1, OCLD, and MUC12 expression increased by 14% (P = 0.17), 23% (P = 0.11), and 22% (P = 0.07), respectively. In secondary analyses, the estimated calcium treatment effects were greater among participants with baseline serum 25-OH-vitamin D concentrations below the median value of 22.69 ng/mL (CLDN1: 29%, P = 0.04; OCLD: 36%, P = 0.06; MUC12: 35%, P = 0.05). There were no biomarker expression changes in the vitamin D 3 alone group; however, modest increases were found in the combined calcium/vitamin D 3 group. At baseline, obesity, history of a sessile-serrated adenoma, colorectal MIB-1/Ki-67 expression, and a family history of colorectal cancer were associated with CLDN1, OCLD, and MUC12 expression. Our study supports continued investigation of factors that could affect intestinal mucosal barrier integrity relevant to colorectal carcinogenesis.",2019,"We assessed expression of the tight junction proteins claudin-1 (CLDN1), occludin (OCLD), and mucin-12 (MUC12) in the normal-appearing colorectal mucosa using standardized, automated immunohistochemistry and quantitative image analysis.","['normal rectal mucosa of colorectal adenoma patients', '105 participants from a large colorectal adenoma recurrence chemoprevention clinical trial']","['Calcium and vitamin D', 'CLDN1', 'supplemental calcium and vitamin D', 'supplemental calcium (1200\u2009mg, daily) and/or vitamin D 3']","['baseline serum 25-OH-vitamin D concentrations', 'biomarker expression changes', 'intestinal barrier function-related biomarkers', 'CLDN1, OCLD, and MUC12 expression', 'expression of the tight junction proteins claudin-1 (CLDN1), occludin (OCLD), and mucin-12 (MUC12']","[{'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0205052', 'cui_str': 'Rectal (qualifier value)'}, {'cui': 'C0026724', 'cui_str': 'Mucosal Tissue'}, {'cui': 'C0555952', 'cui_str': 'Colorectal (qualifier value)'}, {'cui': 'C0001430', 'cui_str': 'Adenoma'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0282515', 'cui_str': 'Chemoprophylaxis'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}]","[{'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C4517548', 'cui_str': 'One thousand two hundred'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0021853', 'cui_str': 'Intestines'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C3494363', 'cui_str': 'Tight Junction Proteins'}, {'cui': 'C3496132', 'cui_str': 'Claudin-1'}, {'cui': 'C0250400', 'cui_str': 'Occludins'}, {'cui': 'C0026682', 'cui_str': 'Mucins'}]",105.0,0.0608549,"We assessed expression of the tight junction proteins claudin-1 (CLDN1), occludin (OCLD), and mucin-12 (MUC12) in the normal-appearing colorectal mucosa using standardized, automated immunohistochemistry and quantitative image analysis.","[{'ForeName': 'Hannah B', 'Initials': 'HB', 'LastName': 'Mandle', 'Affiliation': 'Department of Epidemiology, Rollins School of Public Health, Emory University, Atlanta, Georgia.'}, {'ForeName': 'Ferdous A', 'Initials': 'FA', 'LastName': 'Jahan', 'Affiliation': 'Department of Epidemiology, Rollins School of Public Health, Emory University, Atlanta, Georgia.'}, {'ForeName': 'Roberd M', 'Initials': 'RM', 'LastName': 'Bostick', 'Affiliation': 'Department of Epidemiology, Rollins School of Public Health, Emory University, Atlanta, Georgia.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Baron', 'Affiliation': 'Department of Epidemiology, Geisel School of Medicine at Dartmouth, Lebanon, New Hampshire.'}, {'ForeName': 'Elizabeth L', 'Initials': 'EL', 'LastName': 'Barry', 'Affiliation': 'Department of Epidemiology, Geisel School of Medicine at Dartmouth, Lebanon, New Hampshire.'}, {'ForeName': 'Rami', 'Initials': 'R', 'LastName': 'Yacoub', 'Affiliation': 'Department of Epidemiology, Rollins School of Public Health, Emory University, Atlanta, Georgia.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Merrill', 'Affiliation': 'Department of Epidemiology, Rollins School of Public Health, Emory University, Atlanta, Georgia.'}, {'ForeName': 'Robin E', 'Initials': 'RE', 'LastName': 'Rutherford', 'Affiliation': 'Department of Medicine, Division of Digestive Diseases, School of Medicine, Emory University, Atlanta, Georgia.'}, {'ForeName': 'March E', 'Initials': 'ME', 'LastName': 'Seabrook', 'Affiliation': 'Consultants in Gastroenterology, West Columbia, South Carolina.'}, {'ForeName': 'Veronika', 'Initials': 'V', 'LastName': 'Fedirko', 'Affiliation': 'Department of Epidemiology, Rollins School of Public Health, Emory University, Atlanta, Georgia.'}]",Molecular carcinogenesis,['10.1002/mc.23010'] 708,30957167,Analysis of Pooled Phase III Efficacy Data for Delafloxacin in Acute Bacterial Skin and Skin Structure Infections.,"BACKGROUND Delafloxacin is an oral or intravenous (IV) antibiotic indicated for the treatment of acute bacterial skin and skin structure infections (ABSSSI), including both gram-positive (including methicillin-resistant Staphylococcus aureus [MRSA]) and gram-negative organisms. Chemically distinct from other quinolones, delafloxacin exhibits enhanced potency, particularly against gram-positive pathogens. The integration of efficacy data across the Phase III ABSSSI studies is presented here and allows for additional examination of results across subgroups. METHODS Results of 2 multicenter, randomized, double-blind trials of 1510 adults with ABSSSI were pooled for this analysis. Subjects in the vancomycin arm received 15 mg/kg, plus 1-2 g of aztreonam every 12 hours. Delafloxacin was dosed at 300 mg IV every 12 hours in Study 302; dosing in Study 303 was 300 mg IV every 12 hours for 3 days, with a mandatory, blinded switch to delafloxacin at 450 mg orally every 12 hours. The primary endpoint was objective response (OR), defined as a ≥20% reduction of lesion spread of erythema area at the primary infection site at 48 to 72 hours (±2 hours), in the absence of clinical failure. Investigator-assessed response, based on the resolution of signs and symptoms at follow-up (FU; Day 14 ± 1) and late follow-up (LFU; Day 21- 28), were secondary endpoints. RESULTS In the intent-to-treat analysis set, the OR was 81.3% in the delafloxacin arm and 80.7% in the comparator arm (mean treatment difference 0.8%, 95% confidence interval -3.2% to 4.7). Results for OR in the defined subgroups showed delafloxacin to be comparable to vancomycin/aztreonam. Investigator-assessed success was similar at FU (84.7% versus 84.1%) and LFU (82.0% versus 81.7%). Delafloxacin was comparable to vancomycin/aztreonam in the eradication of MRSA, at 98.1% versus 98.0%, respectively, at FU. The frequencies of treatment-emergent adverse events between the groups were similar. CONCLUSIONS Overall, IV/oral delafloxacin fixed-dose monotherapy was non-inferior to IV vancomycin/aztreonam combination therapy and was well tolerated in each Phase III study, as well as in the pooled analysis, regardless of endpoint or analysis population.",2019,"Delafloxacin was comparable to vancomycin/aztreonam in the eradication of MRSA, at 98.1% versus 98.0%, respectively, at FU.",['1510 adults with ABSSSI'],"['aztreonam', 'Delafloxacin', 'quinolones, delafloxacin', 'vancomycin', 'delafloxacin', 'vancomycin/aztreonam combination therapy', 'vancomycin/aztreonam']","['frequencies of treatment-emergent adverse events', 'objective response (OR), defined as a ≥20% reduction of lesion spread of erythema area', 'Investigator-assessed success', 'LFU']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4552483', 'cui_str': 'ABSSSI'}]","[{'cui': 'C0004521', 'cui_str': 'Aztreonam'}, {'cui': 'C2828290', 'cui_str': 'delafloxacin'}, {'cui': 'C0034428', 'cui_str': 'Oxoquinolines'}, {'cui': 'C0042313', 'cui_str': 'Vancomycin'}, {'cui': 'C0556895', 'cui_str': 'Combination therapy (regime/therapy)'}]","[{'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0332261', 'cui_str': 'Spread (attribute)'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0035173', 'cui_str': 'Investigators'}]",1510.0,0.219253,"Delafloxacin was comparable to vancomycin/aztreonam in the eradication of MRSA, at 98.1% versus 98.0%, respectively, at FU.","[{'ForeName': 'Philip A', 'Initials': 'PA', 'LastName': 'Giordano', 'Affiliation': 'Department of Emergency Medicine, Orlando Health, Florida.'}, {'ForeName': 'Jason M', 'Initials': 'JM', 'LastName': 'Pogue', 'Affiliation': 'Division of Infectious Diseases, Detroit Medical Center, Wayne State University, Michigan.'}, {'ForeName': 'Sue', 'Initials': 'S', 'LastName': 'Cammarata', 'Affiliation': 'Melinta Therapeutics, Lincolnshire, Illinois.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciz006'] 709,30694974,Histamine-Receptor Antagonists Slow 10-km Cycling Performance in Competitive Cyclists.,"Histamine is released within skeletal muscle during exercise. In humans, antihistamines have no effect on speed, power output, or time-to-completion of short-duration high-intensity exercise. In mice, blocking histamine's actions decreases speed and duration of endurance tasks. It is unknown if these opposing outcomes are the result of differences in histamine's actions between species or are related to duration and/or intensity of exercise, as blocking histamine during endurance exercise has not been examined in humans. PURPOSE Determine the effects of histamine-receptor antagonism on cycling time trial performance in humans, with and without a preceding bout of sustained steady-state exercise. METHODS Eleven (3F) competitive cyclists performed six 10-km time trials on separate days. The first two time trials served as familiarization. The next four time trials were performed in randomized-block order, where two were preceded by 120 min of seated rest (rest) and two by 120 min of cycling exercise (Exercise) at 50% V˙O2peak. Within each block, subjects consumed either combined histamine H1 and H2 receptor antagonists (Blockade) or Placebo, before the start of the 120-min Rest/Exercise. RESULTS Blockade had no discernible effects on hemodynamic or metabolic variables during Rest or Exercise. However, Blockade increased time-to-completion of the 10-km time trial compared with Placebo (+10.5 ± 3.7 s, P < 0.05). Slowing from placebo to blockade was not different between rest (+8.7 ± 5.2 s) and Exercise (+12.3 ± 5.8 s, P = 0.716). CONCLUSIONS Exercise-related histaminergic signaling appears inherent to endurance exercise and may play a role in facilitating optimal function during high-intensity endurance exercise.",2019,"In humans, antihistamines have no effect on speed, power output, or time-to-completion of short-duration high-intensity exercise.","['humans, with and without a preceding bout of sustained steady-state exercise', 'Competitive Cyclists', 'Eleven (3F) competitive cyclists performed six 10-km time trials on separate days']","['Placebo', 'seated rest (rest) and two by 120 min of cycling exercise (Exercise) at 50% V˙O2peak', 'combined histamine H1 and H2 receptor antagonists (Blockade) or Placebo', 'histamine-receptor antagonism', 'Histamine']","['duration of endurance tasks', 'hemodynamic or metabolic variables', 'speed, power output, or time-to-completion of short-duration high-intensity exercise']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0205361', 'cui_str': 'Steady (qualifier value)'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0443299', 'cui_str': 'Separate (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0019588', 'cui_str': 'Histamine'}, {'cui': 'C3653430', 'cui_str': 'Histamine H2 receptor antagonists for peptic ulcer and GORD'}, {'cui': 'C0034813', 'cui_str': 'Histamine Receptor'}]","[{'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0518031', 'cui_str': 'Endurance capacity'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0445194', 'cui_str': 'Power output (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0439593', 'cui_str': 'Short duration (qualifier value)'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]",,0.172558,"In humans, antihistamines have no effect on speed, power output, or time-to-completion of short-duration high-intensity exercise.","[{'ForeName': 'Matthew R', 'Initials': 'MR', 'LastName': 'Ely', 'Affiliation': 'Department of Human Physiology, University of Oregon, Eugene, OR.'}, {'ForeName': 'Dylan C', 'Initials': 'DC', 'LastName': 'Sieck', 'Affiliation': 'Department of Human Physiology, University of Oregon, Eugene, OR.'}, {'ForeName': 'Joshua E', 'Initials': 'JE', 'LastName': 'Mangum', 'Affiliation': 'Department of Human Physiology, University of Oregon, Eugene, OR.'}, {'ForeName': 'Emily A', 'Initials': 'EA', 'LastName': 'Larson', 'Affiliation': 'Department of Human Physiology, University of Oregon, Eugene, OR.'}, {'ForeName': 'Leandro C', 'Initials': 'LC', 'LastName': 'Brito', 'Affiliation': 'School of Physical Education and Sport, University of São Paulo, São Paulo, BRAZIL.'}, {'ForeName': 'Christopher T', 'Initials': 'CT', 'LastName': 'Minson', 'Affiliation': 'Department of Human Physiology, University of Oregon, Eugene, OR.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Halliwill', 'Affiliation': 'Department of Human Physiology, University of Oregon, Eugene, OR.'}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000001911'] 710,31161217,"Effects of red meat, white meat, and nonmeat protein sources on atherogenic lipoprotein measures in the context of low compared with high saturated fat intake: a randomized controlled trial.","BACKGROUND Dietary recommendations to limit red meat are based on observational studies linking intake to cardiovascular disease (CVD) risk together with the potential of its saturated fatty acid (SFA) content to raise low-density lipoprotein (LDL) cholesterol. However, the relation of white meat to CVD risk, and the effects of dietary protein source on lipoprotein particle subfractions, have not been extensively evaluated. OBJECTIVE We tested whether levels of atherogenic lipids and lipoproteins differed significantly following consumption of diets with high red meat content compared with diets with similar amounts of protein derived from white meat or nonmeat sources, and whether these effects were modified by concomitant intake of high compared with low SFAs. METHODS Generally healthy men and women, 21-65 y, body mass index 20-35 kg/m2, were randomly assigned to 1 of 2 parallel arms (high or low SFA) and within each, allocated to red meat, white meat, and nonmeat protein diets consumed for 4 wk each in random order. The primary outcomes were LDL cholesterol, apolipoprotein B (apoB), small + medium LDL particles, and total/high-density lipoprotein cholesterol. RESULTS Analysis included participants who completed all 3 dietary protein assignments (61 for high SFA; 52 for low SFA). LDL cholesterol and apoB were higher with red and white meat than with nonmeat, independent of SFA content (P < 0.0001 for all, except apoB: red meat compared with nonmeat [P = 0.0004]). This was due primarily to increases in large LDL particles, whereas small + medium LDL and total/high-density lipoprotein cholesterol were unaffected by protein source (P = 0.10 and P = 0.51, respectively). Primary outcomes did not differ significantly between red and white meat. Independent of protein source, high compared with low SFA increased LDL cholesterol (P = 0.0003), apoB (P = 0.0002), and large LDL (P = 0.0002). CONCLUSIONS The findings are in keeping with recommendations promoting diets with a high proportion of plant-based food but, based on lipid and lipoprotein effects, do not provide evidence for choosing white over red meat for reducing CVD risk. This trial was registered at Clinicaltrials.gov as NCT01427855.",2019,"LDL cholesterol and apoB were higher with red and white meat than with nonmeat, independent of SFA content (P < 0.0001 for all, except apoB: red meat compared with nonmeat [P = 0.0004]).","['Generally healthy men and women, 21-65 y, body mass index', '20-35 kg/m2']","['red meat, white meat, and nonmeat protein sources']","['LDL cholesterol, apolipoprotein B (apoB', 'red and white meat', 'atherogenic lipids and lipoproteins', 'large LDL', 'atherogenic lipoprotein measures', 'large LDL particles', 'LDL cholesterol', 'LDL cholesterol and apoB', 'density lipoprotein cholesterol', 'SFA content']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}]","[{'cui': 'C0452848', 'cui_str': 'Red Meat'}, {'cui': 'C0452888', 'cui_str': 'Poultry (substance)'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C4521696', 'cui_str': 'Source (property)'}]","[{'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0003593', 'cui_str': 'ApoB'}, {'cui': 'C0332575', 'cui_str': 'Red color (finding)'}, {'cui': 'C0452888', 'cui_str': 'Poultry (substance)'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0023820', 'cui_str': 'Circulating Lipoproteins'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0178587', 'cui_str': 'Mass to volume ratio'}, {'cui': 'C0065055', 'cui_str': 'lipoprotein cholesterol'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}]",,0.249524,"LDL cholesterol and apoB were higher with red and white meat than with nonmeat, independent of SFA content (P < 0.0001 for all, except apoB: red meat compared with nonmeat [P = 0.0004]).","[{'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Bergeron', 'Affiliation': ""Children's Hospital Oakland Research Institute, Oakland, CA.""}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Chiu', 'Affiliation': ""Children's Hospital Oakland Research Institute, Oakland, CA.""}, {'ForeName': 'Paul T', 'Initials': 'PT', 'LastName': 'Williams', 'Affiliation': 'Department of Genome Sciences, Life Sciences Division, Lawrence Berkeley National Laboratory, Berkeley, CA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'M King', 'Affiliation': ""Children's Hospital Oakland Research Institute, Oakland, CA.""}, {'ForeName': 'Ronald M', 'Initials': 'RM', 'LastName': 'Krauss', 'Affiliation': ""Children's Hospital Oakland Research Institute, Oakland, CA.""}]",The American journal of clinical nutrition,['10.1093/ajcn/nqz035'] 711,31084635,Dynamic interpersonal therapy for moderate to severe depression: a pilot randomized controlled and feasibility trial.,"BACKGROUND Improving Access to Psychological Therapies (IAPT) services treat most patients in England who present to primary care with major depression. Psychodynamic psychotherapy is one of the psychotherapies offered. Dynamic Interpersonal Therapy (DIT) is a psychodynamic and mentalization-based treatment for depression. 16 sessions are delivered over approximately 5 months. Neither DIT's effectiveness relative to low-intensity treatment (LIT), nor the feasibility of randomizing patients to psychodynamic or cognitive-behavioural treatments (CBT) in an IAPT setting has been demonstrated. METHODS 147 patients were randomized in a 3:2:1 ratio to DIT (n = 73), LIT (control intervention; n = 54) or CBT (n = 20) in four IAPT treatment services in a combined superiority and feasibility design. Patients meeting criteria for major depressive disorder were assessed at baseline, mid-treatment (3 months) and post-treatment (6 months) using the Hamilton Rating Scale for Depression (HRSD-17), Beck Depression Inventory-II (BDI-II) and other self-rated questionnaire measures. Patients receiving DIT were also followed up 6 months post-completion. RESULTS The DIT arm showed significantly lower HRSD-17 scores at the 6-month primary end-point compared with LIT (d = 0.70). Significantly more DIT patients (51%) showed clinically significant change on the HRSD-17 compared with LIT (9%). The DIT and CBT arms showed equivalence on most outcomes. Results were similar with the BDI-II. DIT showed benefit across a range of secondary outcomes. CONCLUSIONS DIT delivered in a primary care setting is superior to LIT and can be appropriately compared with CBT in future RCTs.",2020,The DIT arm showed significantly lower HRSD-17 scores at the 6-month primary end-point compared with LIT (d = 0.70).,"['147 patients', 'moderate to severe depression', 'patients in England who present to primary care with major depression']","['IAPT treatment services', 'Dynamic interpersonal therapy', 'Psychodynamic psychotherapy', 'Dynamic Interpersonal Therapy (DIT', 'Psychological Therapies (IAPT) services', 'LIT (control intervention; n = 54) or CBT']","['HRSD-17', 'Hamilton Rating Scale for Depression (HRSD-17), Beck Depression Inventory-II (BDI-II) and other self-rated questionnaire measures', 'HRSD-17 scores']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C1261382', 'cui_str': 'Psychotherapy, Psychodynamic'}, {'cui': 'C0841584', 'cui_str': 'Psychological therapies (procedure)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression (assessment scale)'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory (assessment scale)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",147.0,0.0555702,The DIT arm showed significantly lower HRSD-17 scores at the 6-month primary end-point compared with LIT (d = 0.70).,"[{'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Fonagy', 'Affiliation': 'Research Department of Clinical, Educational and Health Psychology, University College London, London, UK.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Lemma', 'Affiliation': 'Research Department of Clinical, Educational and Health Psychology, University College London, London, UK.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Target', 'Affiliation': 'Research Department of Clinical, Educational and Health Psychology, University College London, London, UK.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': ""O'Keeffe"", 'Affiliation': 'Research Department of Clinical, Educational and Health Psychology, University College London, London, UK.'}, {'ForeName': 'Matthew P', 'Initials': 'MP', 'LastName': 'Constantinou', 'Affiliation': 'Research Department of Clinical, Educational and Health Psychology, University College London, London, UK.'}, {'ForeName': 'Tamara', 'Initials': 'T', 'LastName': 'Ventura Wurman', 'Affiliation': 'Research Department of Clinical, Educational and Health Psychology, University College London, London, UK.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Luyten', 'Affiliation': 'Research Department of Clinical, Educational and Health Psychology, University College London, London, UK.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Allison', 'Affiliation': 'Research Department of Clinical, Educational and Health Psychology, University College London, London, UK.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Roth', 'Affiliation': 'Research Department of Clinical, Educational and Health Psychology, University College London, London, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Cape', 'Affiliation': 'Research Department of Clinical, Educational and Health Psychology, University College London, London, UK.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Pilling', 'Affiliation': 'Research Department of Clinical, Educational and Health Psychology, University College London, London, UK.'}]",Psychological medicine,['10.1017/S0033291719000928'] 712,31653510,"A phase II randomized, double-blind trial of a polyvalent Vaccine-KLH conjugate (NSC 748933 IND# 14384) + OPT-821 versus OPT-821 in patients with epithelial ovarian, fallopian tube, or peritoneal cancer who are in second or third complete remission: An NRG Oncology/GOG study.","OBJECTIVE Early-phase data have demonstrated induction of antibody responses to a polyvalent vaccine conjugate (Globo-H, GM2, MUC1-TN, TF) with adjuvant OPT-821. We sought to determine if this combination decreases the hazard of progression or death compared to OPT-821 alone in patients with ovarian cancer in second/third clinical complete remission following chemotherapy. Secondary and translational objectives were overall survival (OS), safety, and immunogenicity. METHODS From 2010-2013, patients were randomized (1:1) to receive OPT-821±vaccine-KLH conjugate subcutaneously at weeks 1, 2, 3, 7, 11, and then every 12 weeks (total 11). Dose delay or reduction was not permitted. Patients were removed for pre-defined dose-limiting toxicity. RESULTS Of 171 patients randomized, 170 were treated. Most had disease of serous histology (85%), stage 3 disease at diagnosis (77%), and had received 2 prior regimens (68%). 32% received >6 treatment cycles [median 6, each arm (p = 0.33)]. 77% discontinued due to progression, 4% due to toxicity, and 1 due to myeloid dysplastic syndrome (MDS). Maximum toxicities included grade 4 MDS and depression/personality change (1 each, unlikely related), as well as grade 3 gastrointestinal disorders and others (n = 21, 4 related). Lesser adverse events were injection site reactions (82%) and fever (11%). Estimated HR for progression-free survival (PFS) of the vaccine + OPT-821 to OPT-821 arm was 0.98 (95% CI: 0.71-1.36). At a median follow-up of 60 months, median OS was 47 and 46 months, respectively. CONCLUSIONS Vaccine + OPT-821 compared to OPT-821 alone was modestly immunogenic and did not prolong PFS or OS. Multi-remission patients are a viable, well-defined population for exploring innovative consolidation and maintenance approaches. TRIAL REGISTRATION NCT00857545.",2019,"32% received >6 treatment cycles [median 6, each arm (p = 0.33)].","['171 patients randomized, 170 were treated', 'patients with epithelial ovarian, fallopian tube, or peritoneal cancer who are in second or third complete remission: An NRG Oncology/GOG study', 'patients with ovarian cancer in second/third clinical complete remission following chemotherapy', 'From 2010-2013']","['OPT-821 alone', 'OPT-821±vaccine-KLH conjugate', 'polyvalent vaccine conjugate (Globo-H, GM2, MUC1-TN, TF) with adjuvant OPT-821', 'polyvalent Vaccine-KLH conjugate (NSC 748933 IND# 14384)\xa0+ OPT-821 versus OPT-821']","['overall survival (OS), safety, and immunogenicity', 'hazard of progression or death', 'disease of serous histology', 'median OS', 'PFS or OS', 'Estimated HR for progression-free survival (PFS', 'fever', 'Maximum toxicities included grade 4 MDS and depression/personality change']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4517599', 'cui_str': 'One hundred and seventy'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0015560', 'cui_str': 'Oviducts, Mammalian'}, {'cui': 'C0153467', 'cui_str': 'Malignant tumor of peritoneum (disorder)'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1140680', 'cui_str': 'Ovary Cancer'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C0064332', 'cui_str': 'KLH antigen'}, {'cui': 'C0301869', 'cui_str': 'Conjugate'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C1175421', 'cui_str': 'Globo-H'}, {'cui': 'C0119960', 'cui_str': 'GM2(NeuGc)'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0440743', 'cui_str': 'Serous (qualifier value)'}, {'cui': 'C0344441', 'cui_str': 'Histologic test (procedure)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0015967', 'cui_str': 'Hyperthermia'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0265219', 'cui_str': 'Lissencephaly Syndrome, Miller-Dieker'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0240735', 'cui_str': 'Personality change (finding)'}]",170.0,0.384314,"32% received >6 treatment cycles [median 6, each arm (p = 0.33)].","[{'ForeName': 'Roisin E', 'Initials': 'RE', 'LastName': ""O'Cearbhaill"", 'Affiliation': 'Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York, NY, USA. Electronic address: ocearbhr@mskcc.org.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Deng', 'Affiliation': 'NRG Oncology Statistics & Data Management Center, Roswell Park Cancer Institute, Buffalo, NY, USA. Electronic address: wdeng@gogstats.org.'}, {'ForeName': 'Lee-May', 'Initials': 'LM', 'LastName': 'Chen', 'Affiliation': 'University of California San Francisco, San Francisco, CA, USA. Electronic address: lee-may.chen@ucsfmedctr.org.'}, {'ForeName': 'Joseph A', 'Initials': 'JA', 'LastName': 'Lucci', 'Affiliation': 'The University of Texas Health Science Center at Houston, Houston, TX, USA. Electronic address: Joseph.A.Lucci@uth.tmc.edu.'}, {'ForeName': 'Kian', 'Initials': 'K', 'LastName': 'Behbakht', 'Affiliation': 'Rush University Medical Center, Chicago, IL, USA. Electronic address: kian.behbakht@ucdenver.edu.'}, {'ForeName': 'Nick M', 'Initials': 'NM', 'LastName': 'Spirtos', 'Affiliation': ""Women's Cancer Center of Nevada, Las Vegas, NV, USA. Electronic address: nspirtos@wccenter.com.""}, {'ForeName': 'Carolyn Y', 'Initials': 'CY', 'LastName': 'Muller', 'Affiliation': 'Department of Obstetrics and Gynecology, University of New Mexico School of Medicine, Albuquerque, NM, USA. Electronic address: cmuller@salud.unm.edu.'}, {'ForeName': 'Benedict B', 'Initials': 'BB', 'LastName': 'Benigno', 'Affiliation': 'University Gynecologic Oncology, Atlanta, GA, USA. Electronic address: benedict.benigno@ugynonc.com.'}, {'ForeName': 'Matthew A', 'Initials': 'MA', 'LastName': 'Powell', 'Affiliation': 'Washington University School of Medicine, St. Louis, MO, USA. Electronic address: powellm@wudosis.wustl.edu.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Berry', 'Affiliation': ""Northwestern Medicine Prentice Women's Hospital, Chicago, IL, USA. Electronic address: https://dremilyberry.com.""}, {'ForeName': 'Krishnansu S', 'Initials': 'KS', 'LastName': 'Tewari', 'Affiliation': 'University of California Irvine Medical Center, Orange, CA, USA. Electronic address: ktewari@uci.edu.'}, {'ForeName': 'Parviz', 'Initials': 'P', 'LastName': 'Hanjani', 'Affiliation': 'Hanjani Institute for Gynecologic Oncology, Abington Memorial Hospital, Abington, PA, USA. Electronic address: phanjani@aol.com.'}, {'ForeName': 'Heather A', 'Initials': 'HA', 'LastName': 'Lankes', 'Affiliation': 'NRG Oncology, Operations Center-Philadelphia East, Philadelphia PA and Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, The Ohio State University Wexner Medical Center, Columbus, OH, USA. Electronic address: LankesH@NRGOncology.org.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Aghajanian', 'Affiliation': 'Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York, NY, USA. Electronic address: aghajanc@mskcc.org.'}, {'ForeName': 'Paul J', 'Initials': 'PJ', 'LastName': 'Sabbatini', 'Affiliation': 'Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York, NY, USA. Electronic address: sabbatip@mskcc.org.'}]",Gynecologic oncology,['10.1016/j.ygyno.2019.09.015'] 713,31082665,Placebo-controlled randomized clinical trial testing the efficacy and safety of varenicline for smokers with HIV.,"BACKGROUND People living with HIV/AIDS (PLWH) smoke tobacco at higher rates and have more difficulty quitting than the general population, which contributes to significant life-years lost. The effectiveness of varenicline, one of the most effective tobacco dependence treatments, is understudied in HIV. We evaluated the safety and efficacy of varenicline for smoking cessation among PLWH. METHODS This was a single-site randomized, double-blind, placebo-controlled, phase 3 clinical trial (NCT01710137). PLWH on antiretroviral therapy (ART) who were treatment-seeking daily smokers were randomized (1:1) to 12 weeks of varenicline (n = 89) or placebo (n = 90). All participants were offered six smoking cessation behavioral counseling sessions. The primary outcome was 7-day point prevalence abstinence, confirmed with breath carbon monoxide, at Weeks 12 and 24. Continuous abstinence and time to relapse were secondary outcomes. Safety measures were treatment-related side effects, adverse events, blood pressure, viral load, and ART adherence. RESULTS Of the 179 smokers, 81% were African American, and 68% were male. Varenicline increased cessation at Week 12 (28.1% vs. 12.1%; OR = 4.54, 95% CI:1.83-11.25, P = .001). Continuous abstinence from Week 9 to 12 was higher for varenicline vs. placebo (23.6% vs. 10%; OR = 4.65, 95% CI:1.71-12.67, P = .003); at Week 24, there was no effect of varenicline for point prevalence (14.6% vs. 10%), continuous abstinence (10.1% vs. 6.7%), or time to relapse (Ps > .05). There were no differences between varenicline and placebo on safety measures (Ps > .05). CONCLUSIONS Varenicline is safe and efficacious for short-term smoking cessation among PLWH and should be used to reduce tobacco-related life-years lost in this population.",2019,"Varenicline increased cessation at Week 12 (28.1% vs. 12.1%; OR = 4.54, 95% CI:1.83-11.25, P = .001).","[' 81% were African American, and 68% were male', 'People living with HIV/AIDS (PLWH) smoke tobacco', '179 smokers', 'smokers with HIV', 'All participants were offered six smoking cessation behavioral counseling sessions']","['Varenicline', 'placebo', 'varenicline', 'Placebo', 'varenicline vs. placebo', 'PLWH']","['safety and efficacy', 'side effects, adverse events, blood pressure, viral load, and ART adherence', 'continuous abstinence', 'Continuous abstinence', 'Continuous abstinence and time to relapse', 'time to relapse', 'safety measures', 'efficacy and safety', '7-day point prevalence abstinence, confirmed with breath carbon monoxide']","[{'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0040329', 'cui_str': 'Tobacco Products'}, {'cui': 'C4517609', 'cui_str': '179 (qualifier value)'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C4546207', 'cui_str': 'Behavioral counseling (procedure)'}]","[{'cui': 'C1569608', 'cui_str': 'varenicline'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0225386', 'cui_str': 'Breath (substance)'}, {'cui': 'C0007018', 'cui_str': 'Carbon Monoxide'}]",179.0,0.502051,"Varenicline increased cessation at Week 12 (28.1% vs. 12.1%; OR = 4.54, 95% CI:1.83-11.25, P = .001).","[{'ForeName': 'Rebecca L', 'Initials': 'RL', 'LastName': 'Ashare', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania, 3535 Market Street, Suite 4100, Philadelphia, PA, USA. Electronic address: rlashare@pennmedicine.upenn.edu.'}, {'ForeName': 'Morgan', 'Initials': 'M', 'LastName': 'Thompson', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania, 3535 Market Street, Suite 4100, Philadelphia, PA, USA.'}, {'ForeName': 'Katrina', 'Initials': 'K', 'LastName': 'Serrano', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania, 3535 Market Street, Suite 4100, Philadelphia, PA, USA.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Leone', 'Affiliation': 'Pulmonary, Allergy, and Critical Care Division, University of Pennsylvania Presbyterian Medical Center, 51 N. 39th Street, Philadelphia, PA, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Metzger', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania, 3535 Market Street, Suite 4100, Philadelphia, PA, USA.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Frank', 'Affiliation': 'Division of Infectious Diseases, University of Pennsylvania, 3610 Hamilton Walk, Philadelphia, PA, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Gross', 'Affiliation': 'Division of Infectious Diseases, University of Pennsylvania, 3610 Hamilton Walk, Philadelphia, PA, USA; Center for Clinical Epidemiology and Biostatistics, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Hole', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania, 3535 Market Street, Suite 4100, Philadelphia, PA, USA.'}, {'ForeName': 'Karam', 'Initials': 'K', 'LastName': 'Mounzer', 'Affiliation': 'Philadelphia FIGHT, 1233 Locust Street, 3rd Floor, Philadelphia, PA, USA.'}, {'ForeName': 'Ronald G', 'Initials': 'RG', 'LastName': 'Collman', 'Affiliation': 'Pulmonary, Allergy and Critical Care Division, University of Pennsylvania, 522 Johnson Pavilion, 36th and Hamilton Walk, Philadelphia, PA, USA.'}, {'ForeName': 'E Paul', 'Initials': 'EP', 'LastName': 'Wileyto', 'Affiliation': 'Center for Clinical Epidemiology and Biostatistics, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Schnoll', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania, 3535 Market Street, Suite 4100, Philadelphia, PA, USA.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2019.03.011'] 714,30826253,Effects of Ketamine on Brain Activity During Emotional Processing: Differential Findings in Depressed Versus Healthy Control Participants.,"BACKGROUND In the search for novel treatments for depression, ketamine has emerged as a unique agent with rapid antidepressant effects. Experimental tasks involving emotional processing can be used during functional magnetic resonance imaging scanning to investigate ketamine's effects on brain function in major depressive disorder (MDD). This study examined ketamine's effects on functional magnetic resonance imaging activity during an emotional processing task. METHODS A total of 33 individuals with treatment-resistant MDD and 24 healthy control participants (HCs) took part in this double-blind, placebo-controlled crossover study. Participants received ketamine and placebo infusions 2 weeks apart, and functional magnetic resonance imaging scans were conducted at baseline and 2 days after each infusion. Blood oxygen level-dependent signal was measured during an emotional processing task, and a linear mixed-effects model was used to analyze differences in activation among group, drug, and task-specific factors. RESULTS A group-by-drug interaction was observed in several brain regions, including a right frontal cluster extending into the anterior cingulate cortex and insula. Participants with MDD had greater activity than HCs after placebo infusion but showed lower activity after ketamine infusion, which was similar to the activity in HCs after placebo. A group-by-drug-by-task condition interaction was also found, which showed further differences that varied between implicit and explicit emotional conditions. CONCLUSIONS The main results indicate that ketamine had differential effects on brain activity in participants with MDD versus HCs. The pattern of activation in participants with MDD after ketamine infusion resembled the activation in HCs after placebo infusion, suggesting a normalization of function during emotional processing. The findings contribute to a better understanding of ketamine's actions in the brain.",2019,"Participants with MDD had greater activity than HCs after placebo infusion but showed lower activity after ketamine infusion, which was similar to the activity in HCs after placebo.","['major depressive disorder (MDD', 'Depressed Versus Healthy Control Participants', '33 individuals with treatment-resistant MDD and 24 healthy control participants (HCs', 'participants with MDD after']","['Ketamine', 'ketamine', 'ketamine and placebo', 'placebo']","['Brain Activity', 'brain activity', 'activity', 'Blood oxygen level-dependent signal', 'functional magnetic resonance imaging activity', 'activation in HCs']","[{'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332325', 'cui_str': 'Resistant (qualifier value)'}]","[{'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0443158', 'cui_str': 'Brain activity (observable entity)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0005768'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}, {'cui': 'C0376335', 'cui_str': 'fMRI'}]",33.0,0.194592,"Participants with MDD had greater activity than HCs after placebo infusion but showed lower activity after ketamine infusion, which was similar to the activity in HCs after placebo.","[{'ForeName': 'Jessica L', 'Initials': 'JL', 'LastName': 'Reed', 'Affiliation': 'Section on Neurobiology and Treatment of Mood Disorders, Intramural Research Program, National Institute of Mental Health, National Institutes of Health, Bethesda, Maryland. Electronic address: jessica.reed2@nih.gov.'}, {'ForeName': 'Allison C', 'Initials': 'AC', 'LastName': 'Nugent', 'Affiliation': 'Section on Neurobiology and Treatment of Mood Disorders, Intramural Research Program, National Institute of Mental Health, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Maura L', 'Initials': 'ML', 'LastName': 'Furey', 'Affiliation': 'Section on Neurobiology and Treatment of Mood Disorders, Intramural Research Program, National Institute of Mental Health, National Institutes of Health, Bethesda, Maryland; Janssen Pharmaceuticals of Johnson & Johnson, San Diego, California.'}, {'ForeName': 'Joanna E', 'Initials': 'JE', 'LastName': 'Szczepanik', 'Affiliation': 'Section on Neurobiology and Treatment of Mood Disorders, Intramural Research Program, National Institute of Mental Health, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Jennifer W', 'Initials': 'JW', 'LastName': 'Evans', 'Affiliation': 'Section on Neurobiology and Treatment of Mood Disorders, Intramural Research Program, National Institute of Mental Health, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Carlos A', 'Initials': 'CA', 'LastName': 'Zarate', 'Affiliation': 'Section on Neurobiology and Treatment of Mood Disorders, Intramural Research Program, National Institute of Mental Health, National Institutes of Health, Bethesda, Maryland.'}]",Biological psychiatry. Cognitive neuroscience and neuroimaging,['10.1016/j.bpsc.2019.01.005'] 715,30929458,The effects of a short-term mindfulness meditation intervention on coping flexibility.,"Background and objectives: Mindfulness meditation (MM) training promotes health and well-being. One potential mechanistic link between MM and health may be coping flexibility, (e.g., the ability to monitor and modify coping strategies based on situational needs and strategy effectiveness). We hypothesized that MM training would increase coping flexibility and also explored whether gains in coping flexibility continued to increase after training, or whether they were maintained or lost with time. Methods and design: One hundred thirteen students (71 female, M age  = 18.97) were randomly assigned to a waitlist control or MM condition. Participants in the MM condition were trained by a certified MM instructor and given guided recordings for one-week of at-home practice. Participants provided reports of coping flexibility over a three-week span. Results: Results from multilevel modeling indicated that MM increased coping flexibility among those in the MM condition and among those who spent relatively more time meditating. Results further suggested that the gains in coping flexibility that were evident at post-test were not only maintained but increased in the two weeks after the intervention. Conclusions: This study provides preliminary support for the assertion that MM increases the ability to monitor and modify coping strategies during times of stress.",2019,This study provides preliminary support for the assertion that MM increases the ability to monitor and modify coping strategies during times of stress.,"['One hundred thirteen students (71 female, M age \u2009=\u200918.97']","['Mindfulness meditation (MM) training', 'waitlist control or MM condition', 'MM training', 'short-term mindfulness meditation intervention']",['coping flexibility'],"[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0150277'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}]","[{'cui': 'C0242808', 'cui_str': 'Flexibility'}]",113.0,0.0215618,This study provides preliminary support for the assertion that MM increases the ability to monitor and modify coping strategies during times of stress.,"[{'ForeName': 'Dusti R', 'Initials': 'DR', 'LastName': 'Jones', 'Affiliation': 'a Department of Psychology , Western Washington University , Bellingham , WA , USA.'}, {'ForeName': 'Barbara J', 'Initials': 'BJ', 'LastName': 'Lehman', 'Affiliation': 'a Department of Psychology , Western Washington University , Bellingham , WA , USA.'}, {'ForeName': 'Alysia', 'Initials': 'A', 'LastName': 'Noriega', 'Affiliation': 'a Department of Psychology , Western Washington University , Bellingham , WA , USA.'}, {'ForeName': 'Dale L', 'Initials': 'DL', 'LastName': 'Dinnel', 'Affiliation': 'a Department of Psychology , Western Washington University , Bellingham , WA , USA.'}]","Anxiety, stress, and coping",['10.1080/10615806.2019.1596672'] 716,30872104,Efficacy of Budesonide vs Fluticasone for Initial Treatment of Eosinophilic Esophagitis in a Randomized Controlled Trial.,"BACKGROUND AND AIMS Topical steroid treatments for eosinophilic esophagitis (EoE) include swallowed fluticasone from a multi-dose inhaler (MDI) or oral viscous budesonide (OVB) slurry, but the 2 have never been compared. We assessed whether OVB was more effective than MDI for initial treatment of patients with EoE. METHODS In a double-blind, double-dummy trial, patients with a new diagnosis of EoE were randomly assigned to groups given 8 weeks of either OVB (1 mg/4 mL) twice daily plus a placebo inhaler (n = 56) or fluticasone MDI (880 μg) twice daily plus a placebo slurry (n = 55). Primary outcomes were post-treatment maximum eosinophil counts per high-power field (eos/hpf) and a validated dysphagia score (dysphagia symptom questionnaire [DSQ]) at week 8. Secondary outcomes included endoscopic severity (validated EoE endoscopic reference score), histologic response (<15 eos/hpf), and safety. RESULTS In a modified intention-to-treat analysis, the subjects had baseline peak eosinophil counts of 73 and 77 eos/hpf in the OVB and MDI groups, respectively, and DSQ scores of 11 and 8. Post-treatment eosinophil counts were 15 and 21 in the OVB and MDI groups, respectively (P = .31), with 71% and 64% achieving histologic response (P = .38). DSQ scores were 5 and 4 in the OVB and MDI groups (P = .70). Similar trends were noted for post-treatment total EoE endoscopic reference scores (2 vs 3; P = .06). Esophageal candidiasis developed in 12% of patients receiving OVB and 16% receiving MDI; oral thrush was observed in 3% and 2%, respectively. CONCLUSIONS In a randomized clinical trial, initial treatment of EoE with either OVB or fluticasone MDI produced a significant decrease in esophageal eosinophil counts and improved dysphagia and endoscopic features. However, OVB was not superior to MDI, so either is an acceptable treatment for EoE. ClinicalTrials.gov ID NCT02019758.",2019,Similar trends were noted for post-treatment total EoE endoscopic reference scores (2 vs 3; P = .06).,['patients with a new diagnosis of EoE'],"['oral viscous budesonide (OVB) slurry', 'fluticasone MDI (880 μg) twice daily plus a placebo slurry', 'OVB (1 mg/4 mL) twice daily plus a placebo', 'OVB or fluticasone MDI', 'Budesonide vs Fluticasone', 'OVB', 'Topical steroid']","['Post-treatment eosinophil counts', 'post-treatment maximum eosinophil counts per high-power field (eos/hpf) and a validated dysphagia score (dysphagia symptom questionnaire [DSQ', 'DSQ scores', 'baseline peak eosinophil counts', 'post-treatment total EoE endoscopic reference scores', 'esophageal eosinophil counts and improved dysphagia and endoscopic features', 'Esophageal candidiasis', 'histologic response', 'endoscopic severity (validated EoE endoscopic reference score), histologic response (<15 eos/hpf), and safety']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2585997', 'cui_str': 'New diagnosis (observable entity)'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0054201', 'cui_str': 'Budesonide'}, {'cui': 'C0082607', 'cui_str': 'fluticasone'}, {'cui': 'C0993596', 'cui_str': 'Metered Dose Inhaler'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0038317', 'cui_str': 'Steroids'}]","[{'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0200638', 'cui_str': 'Eosinophil count - observation'}, {'cui': 'C0439530', 'cui_str': 'per high power field'}, {'cui': 'C0011168', 'cui_str': 'Dysphagia'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0205462', 'cui_str': 'Histologic (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.495856,Similar trends were noted for post-treatment total EoE endoscopic reference scores (2 vs 3; P = .06).,"[{'ForeName': 'Evan S', 'Initials': 'ES', 'LastName': 'Dellon', 'Affiliation': 'Center for Esophageal Diseases and Swallowing, and Center for Gastrointestinal Biology and Disease, Division of Gastroenterology and Hepatology, University of North Carolina School of Medicine, Chapel Hill, North Carolina. Electronic address: edellon@med.unc.edu.'}, {'ForeName': 'John T', 'Initials': 'JT', 'LastName': 'Woosley', 'Affiliation': 'Department of Pathology and Laboratory Medicine, University of North Carolina School of Medicine, Chapel Hill, North Carolina.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Arrington', 'Affiliation': 'Center for Esophageal Diseases and Swallowing, and Center for Gastrointestinal Biology and Disease, Division of Gastroenterology and Hepatology, University of North Carolina School of Medicine, Chapel Hill, North Carolina.'}, {'ForeName': 'Sarah J', 'Initials': 'SJ', 'LastName': 'McGee', 'Affiliation': 'Center for Esophageal Diseases and Swallowing, and Center for Gastrointestinal Biology and Disease, Division of Gastroenterology and Hepatology, University of North Carolina School of Medicine, Chapel Hill, North Carolina.'}, {'ForeName': 'Jacquelyn', 'Initials': 'J', 'LastName': 'Covington', 'Affiliation': 'Center for Esophageal Diseases and Swallowing, and Center for Gastrointestinal Biology and Disease, Division of Gastroenterology and Hepatology, University of North Carolina School of Medicine, Chapel Hill, North Carolina.'}, {'ForeName': 'Susan E', 'Initials': 'SE', 'LastName': 'Moist', 'Affiliation': 'Center for Esophageal Diseases and Swallowing, and Center for Gastrointestinal Biology and Disease, Division of Gastroenterology and Hepatology, University of North Carolina School of Medicine, Chapel Hill, North Carolina.'}, {'ForeName': 'Jessica H', 'Initials': 'JH', 'LastName': 'Gebhart', 'Affiliation': 'Center for Esophageal Diseases and Swallowing, and Center for Gastrointestinal Biology and Disease, Division of Gastroenterology and Hepatology, University of North Carolina School of Medicine, Chapel Hill, North Carolina.'}, {'ForeName': 'Alexandra E', 'Initials': 'AE', 'LastName': 'Tylicki', 'Affiliation': 'Center for Esophageal Diseases and Swallowing, and Center for Gastrointestinal Biology and Disease, Division of Gastroenterology and Hepatology, University of North Carolina School of Medicine, Chapel Hill, North Carolina.'}, {'ForeName': 'Shiyan O', 'Initials': 'SO', 'LastName': 'Shoyoye', 'Affiliation': 'Center for Esophageal Diseases and Swallowing, and Center for Gastrointestinal Biology and Disease, Division of Gastroenterology and Hepatology, University of North Carolina School of Medicine, Chapel Hill, North Carolina.'}, {'ForeName': 'Christopher F', 'Initials': 'CF', 'LastName': 'Martin', 'Affiliation': 'Center for Esophageal Diseases and Swallowing, and Center for Gastrointestinal Biology and Disease, Division of Gastroenterology and Hepatology, University of North Carolina School of Medicine, Chapel Hill, North Carolina.'}, {'ForeName': 'Joseph A', 'Initials': 'JA', 'LastName': 'Galanko', 'Affiliation': 'Center for Esophageal Diseases and Swallowing, and Center for Gastrointestinal Biology and Disease, Division of Gastroenterology and Hepatology, University of North Carolina School of Medicine, Chapel Hill, North Carolina.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Baron', 'Affiliation': 'Center for Esophageal Diseases and Swallowing, and Center for Gastrointestinal Biology and Disease, Division of Gastroenterology and Hepatology, University of North Carolina School of Medicine, Chapel Hill, North Carolina.'}, {'ForeName': 'Nicholas J', 'Initials': 'NJ', 'LastName': 'Shaheen', 'Affiliation': 'Center for Esophageal Diseases and Swallowing, and Center for Gastrointestinal Biology and Disease, Division of Gastroenterology and Hepatology, University of North Carolina School of Medicine, Chapel Hill, North Carolina.'}]",Gastroenterology,['10.1053/j.gastro.2019.03.014'] 717,31033232,Effect of Group-Based Outpatient Physical Therapy on Function After Total Knee Replacement: Results From a Multicenter Randomized Controlled Trial.,"OBJECTIVE To evaluate the long-term clinical effectiveness of a novel group-based outpatient physical therapy (PT) following total knee replacement (TKR). METHODS In this 2-center, unblinded, superiority, randomized controlled trial, 180 patients on a waiting list for primary TKR due to osteoarthritis were randomized to a 6 session group-based outpatient PT intervention and usual care (n = 89) or usual care alone (n = 91). The primary outcome was patient-reported functional ability measured by the Lower Extremity Functional Scale at 12 months postoperative. Secondary outcomes included knee symptoms, depression, anxiety, and satisfaction. Questionnaires were completed preoperatively and at 3, 6, and 12 months postoperatively. RESULTS The mean difference in function between groups was 4.47 (95% confidence interval [95% CI] 0.20, 8.75; P = 0.04) at 12 months postoperative, favoring the intervention. The mean difference in function between groups decreased over time, from 8.1 points at 3 months (95% CI 3.8, 12.4; P < 0.001) to 5.4 (95% CI 1.1, 9.8; P = 0.015) at 6 months postoperative. There were no clinically relevant differences in any secondary outcomes between groups, although patients in the intervention group were more likely to be satisfied with their PT. No serious adverse events related to the intervention were reported. CONCLUSION Supplementing usual care with this group-based outpatient PT intervention led to improvements in function at 12 months after TKR, although the magnitude of the difference was below the minimum clinically important difference of 9 points. However, patient satisfaction was higher in the intervention group, and there was some evidence of clinically relevant improvements in function at 3 months.",2020,"Supplementing usual care with this group-based outpatient physiotherapy intervention led to improvements in function at 12 months after TKR, although the magnitude of the difference was below the minimal clinically important different of 9 points.","['function after total knee replacement', '180 patients on a waiting list for primary TKR due to osteoarthritis']","['6 session group-based outpatient physiotherapy intervention and usual care (n=89) or usual care alone', 'novel group-based outpatient physiotherapy following total knee replacement (TKR', 'group-based outpatient physiotherapy']","['knee symptoms, depression, anxiety and satisfaction', 'patient satisfaction', 'patient-reported functional ability measured by the Lower Extremity Functional Scale']","[{'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0029408', 'cui_str': 'Arthritis, Degenerative'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}]","[{'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C4305121', 'cui_str': 'Lower Extremity Functional Scale (assessment scale)'}]",180.0,0.145058,"Supplementing usual care with this group-based outpatient physiotherapy intervention led to improvements in function at 12 months after TKR, although the magnitude of the difference was below the minimal clinically important different of 9 points.","[{'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Lenguerrand', 'Affiliation': 'University of Bristol, Bristol, UK.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Artz', 'Affiliation': 'University of West of England, Bristol, UK.'}, {'ForeName': 'Elsa', 'Initials': 'E', 'LastName': 'Marques', 'Affiliation': 'University of Bristol, Bristol, UK.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Sanderson', 'Affiliation': 'University of Bristol, Bristol, UK.'}, {'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Lewis', 'Affiliation': 'Southmead Hospital, North Bristol NHS Trust, Bristol, UK.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Murray', 'Affiliation': 'University of Bristol and Southmead Hospital, North Bristol NHS Trust, Bristol, UK.'}, {'ForeName': 'Tarique', 'Initials': 'T', 'LastName': 'Parwez', 'Affiliation': 'Luton and Dunstable Hospital, Luton and Dunstable University Hospital NHS Foundation Trust, Luton, UK.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Bertram', 'Affiliation': 'University of Bristol and Southmead Hospital, North Bristol NHS Trust, Bristol, UK.'}, {'ForeName': 'Andrew D', 'Initials': 'AD', 'LastName': 'Beswick', 'Affiliation': 'University of Bristol, Bristol, UK.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Burston', 'Affiliation': 'University of Bristol, Bristol, UK.'}, {'ForeName': 'Rachael', 'Initials': 'R', 'LastName': 'Gooberman-Hill', 'Affiliation': 'University of Bristol and NIHR Bristol Biomedical Research Centre, University Hospitals Bristol NHS Foundation Trust, Bristol, UK.'}, {'ForeName': 'Ashley W', 'Initials': 'AW', 'LastName': 'Blom', 'Affiliation': 'University of Bristol, Southmead Hospital, North Bristol NHS Trust, and NIHR Bristol Biomedical Research Centre, University Hospitals Bristol NHS Foundation Trust, Bristol, UK.'}, {'ForeName': 'Vikki', 'Initials': 'V', 'LastName': 'Wylde', 'Affiliation': 'University of Bristol and NIHR Bristol Biomedical Research Centre, University Hospitals Bristol NHS Foundation Trust, Bristol, UK.'}]",Arthritis care & research,['10.1002/acr.23909'] 718,30995350,A placebo-controlled pilot study of a wearable morning bright light treatment for probable PTSD.,"BACKGROUND Evidence-based treatments for post-traumatic stress disorder (PTSD) have poor uptake and remission rates, suggesting that alternative treatments are needed. Morning bright light may be an effective treatment for PTSD given its established effects on mood and sleep, however, there are no published trials. METHODS We conducted a placebo-controlled pilot trial of a wearable light device, the Re-timer®, for individuals with probable PTSD. Individuals were randomly assigned to the active Re-timer® (n = 9) or a placebo Re-timer® dimmed with neutral density filters (n = 6). Participants self-administered the treatment at home 1 hr each morning over 4 weeks. PTSD and depression symptoms were assessed at pre- and post-treatment. RESULTS The Re-timer® was well tolerated and the perceived benefit was high, though treatment adherence was only moderate. Those in the active group were more likely to achieve a minimal clinically important change in PTSD and depression symptoms and had larger symptom reductions than those in the placebo group CONCLUSIONS: A wearable morning light treatment was acceptable and feasible for patients with probable PTSD. This study provides initial proof-of-concept that light treatment can improve PTSD. A larger trial is warranted to establish treatment efficacy. NCT#: 03513848.",2019,Those in the active group were more likely to achieve a minimal clinically important change in PTSD and depression symptoms and had larger symptom reductions than those in the placebo group CONCLUSIONS:,"['patients with probable PTSD', 'individuals with probable PTSD', 'post-traumatic stress disorder (PTSD', 'probable PTSD']","['placebo Re-timer® dimmed with neutral density filters', 'active Re-timer®', 'placebo']","['PTSD and depression symptoms', 'larger symptom reductions']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis (contextual qualifier) (qualifier value)'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0183941', 'cui_str': 'Timer'}, {'cui': 'C0178587', 'cui_str': 'Mass to volume ratio'}, {'cui': 'C0180860', 'cui_str': 'Filter, device (physical object)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}]","[{'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}]",,0.172163,Those in the active group were more likely to achieve a minimal clinically important change in PTSD and depression symptoms and had larger symptom reductions than those in the placebo group CONCLUSIONS:,"[{'ForeName': 'Alyson K', 'Initials': 'AK', 'LastName': 'Zalta', 'Affiliation': 'Department of Psychological Science, University of California, Irvine, Irvine, California.'}, {'ForeName': 'Karyna', 'Initials': 'K', 'LastName': 'Bravo', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Rush University Medical Center, Chicago, Illinois.'}, {'ForeName': 'Zerbrina', 'Initials': 'Z', 'LastName': 'Valdespino-Hayden', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Rush University Medical Center, Chicago, Illinois.'}, {'ForeName': 'Mark H', 'Initials': 'MH', 'LastName': 'Pollack', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Rush University Medical Center, Chicago, Illinois.'}, {'ForeName': 'Helen J', 'Initials': 'HJ', 'LastName': 'Burgess', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Rush University Medical Center, Chicago, Illinois.'}]",Depression and anxiety,['10.1002/da.22897'] 719,31082285,Sleep quality and treatment of social anxiety disorder.,"Background and Objectives: Poor sleep is prevalent among individuals with social anxiety disorder (SAD) and may affect treatment outcome. We examined whether: (1) individuals with SAD differed from healthy controls (HCs) in sleep quality, (2) baseline sleep quality moderated the effects of treatment (Cognitive-behavioral group therapy [CBGT] vs. mindfulness-based stress reduction [MBSR] vs. waitlist [WL]) on social anxiety, (3) sleep quality changed over treatment, and (4) changes in sleep quality predicted anxiety 12-months post-treatment. Design: Participants were 108 adults with SAD from a randomized controlled trial of CBGT vs. MBSR vs. WL and 38 HCs. Methods: SAD and sleep quality were assessed pre-treatment and post-treatment; SAD was assessed again 12-months post-treatment. Results: Participants with SAD reported poorer sleep quality than HCs. The effect of treatment condition on post-treatment social anxiety did not differ as a function of baseline sleep quality. Sleep quality improved in MBSR, significantly more than WL, but not CBGT. Sleep quality change from pre- to post-treatment in CBGT or MBSR did not predict later social anxiety. Conclusions: MBSR, and not CBGT, improved sleep quality among participants. Other results were inconsistent with prior research; possible explanations, limitations, and implications for future research are discussed. ClinicalTrials.gov identifier: NCT02036658.",2019,The effect of treatment condition on post-treatment social anxiety did not differ as a function of baseline sleep quality.,"['individuals with social anxiety disorder (SAD', 'Participants were 108 adults with SAD', 'social anxiety disorder']","['treatment (Cognitive-behavioral group therapy [CBGT] vs. mindfulness-based stress reduction [MBSR] vs. waitlist [WL', 'CBGT or MBSR', 'CBGT vs. MBSR vs. WL and 38 HCs']","['SAD and sleep quality', 'social anxiety, (3) sleep quality changed over treatment, and (4) changes in sleep quality predicted anxiety 12-months post-treatment', 'sleep quality', 'Sleep quality change', 'Sleep quality']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0031572', 'cui_str': 'Social Anxiety Disorder'}, {'cui': 'C4517530', 'cui_str': 'One hundred and eight'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1527374', 'cui_str': 'Group Therapy'}, {'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}]","[{'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0424166', 'cui_str': 'Social Anxiety'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}]",108.0,0.029064,The effect of treatment condition on post-treatment social anxiety did not differ as a function of baseline sleep quality.,"[{'ForeName': 'Arielle', 'Initials': 'A', 'LastName': 'Horenstein', 'Affiliation': 'a Adult Anxiety Clinic, Department of Psychology , Temple University , Philadelphia , PA , USA.'}, {'ForeName': 'Amanda S', 'Initials': 'AS', 'LastName': 'Morrison', 'Affiliation': 'b Department of Psychology , California State University , East Bay , CA , USA.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Goldin', 'Affiliation': 'c Betty Irene Moore School of Nursing , University of California , Davis , CA , USA.'}, {'ForeName': 'Maia', 'Initials': 'M', 'LastName': 'Ten Brink', 'Affiliation': 'd Department of Psychology , Stanford University , Stanford , CA , USA.'}, {'ForeName': 'James J', 'Initials': 'JJ', 'LastName': 'Gross', 'Affiliation': 'd Department of Psychology , Stanford University , Stanford , CA , USA.'}, {'ForeName': 'Richard G', 'Initials': 'RG', 'LastName': 'Heimberg', 'Affiliation': 'a Adult Anxiety Clinic, Department of Psychology , Temple University , Philadelphia , PA , USA.'}]","Anxiety, stress, and coping",['10.1080/10615806.2019.1617854'] 720,31010449,Does trauma-focused exposure therapy exacerbate symptoms among patients with comorbid PTSD and substance use disorders?,"BACKGROUND Although exposure-based therapy is a well-established, effective treatment for post-traumatic stress disorder (PTSD), some practitioners report reluctance to implement it due to concerns that it may exacerbate symptoms of PTSD and commonly comorbid disorders, such as substance use disorders (SUD). AIM This study compared the exacerbation of psychological symptoms among participants with comorbid PTSD and SUD who received either SUD treatment alone or SUD treatment integrated with exposure therapy for PTSD. METHOD Participants (N = 71) were treatment-seeking, military Veterans with comorbid PTSD and SUD who were randomized to 12 individual sessions of either (1) an integrated, exposure-based treatment (Concurrent Treatment of PTSD and Substance Use Disorders using Prolonged Exposure; COPE); or (2) a non-exposure-based, SUD-only treatment (Relapse Prevention; RP). We examined between-group differences in the frequency of statistically reliable exacerbations of PTSD, SUD and depression symptoms experienced during treatment. RESULTS At each of the 12 sessions, symptom exacerbation was minimal and generally equally likely in either treatment group. However, an analysis of treatment completers suggests that RP participants experienced slightly more exacerbations of PTSD symptoms during the course of treatment. CONCLUSIONS This study is the first to investigate symptom exacerbation throughout trauma-focused exposure therapy for individuals with comorbid PTSD and SUD. Results add to a growing literature which suggests that trauma-focused, exposure-based therapy does not increase the risk of symptom exacerbation relative to non-exposure-based therapy.",2020,"We examined between-group differences in the frequency of statistically reliable exacerbations of PTSD, SUD and depression symptoms experienced during treatment. ","['Participants (N = 71) were treatment-seeking, military Veterans with comorbid PTSD and SUD who were randomized to 12', 'participants with comorbid PTSD and SUD who received either', 'individuals with comorbid PTSD and SUD', 'patients with comorbid PTSD and substance use disorders']","['SUD treatment alone or SUD treatment integrated with exposure therapy for PTSD', 'individual sessions of either (1) an integrated, exposure-based treatment (Concurrent Treatment of PTSD and Substance Use Disorders using Prolonged Exposure; COPE); or (2) a non-exposure-based, SUD-only treatment (Relapse Prevention; RP']","['symptom exacerbation', 'exacerbations of PTSD symptoms', 'frequency of statistically reliable exacerbations of PTSD, SUD and depression symptoms']","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0026126', 'cui_str': 'Armed Forces Personnel'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0038586', 'cui_str': 'Substance Use Disorders'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0870527', 'cui_str': 'Exposure Therapy'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0205420', 'cui_str': 'Concurrent (qualifier value)'}, {'cui': 'C0038586', 'cui_str': 'Substance Use Disorders'}, {'cui': 'C0439590', 'cui_str': 'Prolonged (qualifier value)'}, {'cui': 'C0679867', 'cui_str': 'Relapse Prevention'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}]",71.0,0.0170547,"We examined between-group differences in the frequency of statistically reliable exacerbations of PTSD, SUD and depression symptoms experienced during treatment. ","[{'ForeName': 'Cynthia L', 'Initials': 'CL', 'LastName': 'Lancaster', 'Affiliation': 'Department of Psychology, University of Nevada Reno, Reno, NV, USA.'}, {'ForeName': 'Daniel F', 'Initials': 'DF', 'LastName': 'Gros', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Michael C', 'Initials': 'MC', 'LastName': 'Mullarkey', 'Affiliation': 'Department of Psychology, University of Texas, Austin, TX, USA.'}, {'ForeName': 'Christal L', 'Initials': 'CL', 'LastName': 'Badour', 'Affiliation': 'Department of Psychology, University of Kentucky, Lexington, KY, USA.'}, {'ForeName': 'Therese K', 'Initials': 'TK', 'LastName': 'Killeen', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Kathleen T', 'Initials': 'KT', 'LastName': 'Brady', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Sudie E', 'Initials': 'SE', 'LastName': 'Back', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Medical University of South Carolina, Charleston, SC, USA.'}]",Behavioural and cognitive psychotherapy,['10.1017/S1352465819000304'] 721,30725091,Effect of Trimetazidine Dihydrochloride Therapy on Exercise Capacity in Patients With Nonobstructive Hypertrophic Cardiomyopathy: A Randomized Clinical Trial.,"Importance Hypertrophic cardiomyopathy causes limiting symptoms in patients, mediated partly through inefficient myocardial energy use. There is conflicting evidence for therapy with inhibitors of myocardial fatty acid metabolism in patients with nonobstructive hypertrophic cardiomyopathy. Objective To determine the effect of oral therapy with trimetazidine, a direct inhibitor of fatty acid β-oxidation, on exercise capacity in patients with symptomatic nonobstructive hypertrophic cardiomyopathy. Design, Setting, and Participants This randomized, placebo-controlled, double-blind clinical trial at The Heart Hospital, University College London Hospitals, London, United Kingdom was performed between May 31, 2012, and September 8, 2014. The trial included 51 drug-refractory symptomatic (New York Heart Association class ≥2) patients aged 24 to 74 years with a maximum left ventricular outflow tract gradient 50 mm Hg or lower and a peak oxygen consumption during exercise of 80% or less predicted value for age and sex. Statistical analysis was performed from March 1, 2016 through July 4, 2018. Interventions Participants were randomly assigned to trimetazidine, 20 mg, 3 times daily (n = 27) or placebo (n = 24) for 3 months. Main Outcomes and Measures The primary end point was peak oxygen consumption during upright bicycle ergometry. Secondary end points were 6-minute walk distance, quality of life (Minnesota Living with Heart Failure questionnaire), frequency of ventricular ectopic beats, diastolic function, serum N-terminal pro-brain natriuretic peptide level, and troponin T level. Results Of 49 participants who received trimetazidine (n = 26) or placebo (n = 23) and completed the study, 34 (70%) were male; the mean (SD) age was 50 (13) years. Trimetazidine therapy did not improve exercise capacity, with patients in the trimetazidine group walking 38.4 m (95% CI, 5.13 to 71.70 m) less than patients in the placebo group at 3 months after adjustment for their baseline walking distance measurements. After adjustment for baseline values, peak oxygen consumption was 1.35 mL/kg per minute lower (95% CI, -2.58 to -0.11 mL/kg per minute; P = .03) in the intervention group after 3 months. Conclusions and Relevance In symptomatic patients with nonobstructive hypertrophic cardiomyopathy, trimetazidine therapy does not improve exercise capacity. Pharmacologic therapy for this disease remains limited. Trial Registration ClinicalTrials.gov identifier: NCT01696370.",2019,"After adjustment for baseline values, peak oxygen consumption was 1.35 mL/kg per minute lower (95% CI, -2.58 to -0.11 mL/kg per minute; P = .03) in the intervention group after 3 months. ","['51 drug-refractory symptomatic (New York Heart Association class ≥2) patients aged 24 to 74 years with a maximum left ventricular outflow tract gradient 50 mm Hg or lower and a peak oxygen consumption during exercise of 80% or less predicted value for age and sex', 'Patients With Nonobstructive Hypertrophic Cardiomyopathy', 'symptomatic patients with nonobstructive hypertrophic cardiomyopathy', 'Heart Hospital, University College London Hospitals, London, United Kingdom was performed between May 31, 2012, and September 8, 2014', 'patients with nonobstructive hypertrophic cardiomyopathy', '49 participants who received', 'patients with symptomatic nonobstructive hypertrophic cardiomyopathy', 'n\u2009=\u200923) and completed the study, 34 (70%) were male; the mean (SD) age was 50 (13) years']","['Trimetazidine', 'placebo', 'trimetazidine therapy', 'trimetazidine', 'Pharmacologic therapy', 'Trimetazidine Dihydrochloride Therapy', 'trimetazidine, a direct inhibitor of fatty acid β-oxidation']","['6-minute walk distance, quality of life (Minnesota Living with Heart Failure questionnaire), frequency of ventricular ectopic beats, diastolic function, serum N-terminal pro-brain natriuretic peptide level, and troponin T level', 'Exercise Capacity', 'peak oxygen consumption during upright bicycle ergometry', 'peak oxygen consumption', 'exercise capacity']","[{'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0018787', 'cui_str': 'Heart'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0450400', 'cui_str': '50mm (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C1305742', 'cui_str': 'Oxygen consumption'}, {'cui': 'C0587107', 'cui_str': 'During exercise (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0007194', 'cui_str': 'Hypertrophic Cardiomyopathy'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0023973', 'cui_str': 'London'}, {'cui': 'C0041700', 'cui_str': 'United Kingdom'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]","[{'cui': 'C0041037', 'cui_str': 'Trimetazidine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C1564474', 'cui_str': 'Trimetazidine Dihydrochloride'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0015684', 'cui_str': 'Fatty Acids'}, {'cui': 'C0030011', 'cui_str': 'Oxidation, function (observable entity)'}]","[{'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0429886', 'cui_str': 'Walking distance (observable entity)'}, {'cui': 'C0034380'}, {'cui': 'C0026183', 'cui_str': 'Minnesota'}, {'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0151636', 'cui_str': 'Ventricular Ectopic Beats'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C1533071', 'cui_str': 'N-terminal pro-brain natriuretic peptide measurement'}, {'cui': 'C0077404', 'cui_str': 'Troponin T'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C1305742', 'cui_str': 'Oxygen consumption'}, {'cui': 'C0857787', 'cui_str': 'Bicycle ergometry'}]",51.0,0.668121,"After adjustment for baseline values, peak oxygen consumption was 1.35 mL/kg per minute lower (95% CI, -2.58 to -0.11 mL/kg per minute; P = .03) in the intervention group after 3 months. ","[{'ForeName': 'Caroline J', 'Initials': 'CJ', 'LastName': 'Coats', 'Affiliation': 'University College London Institute of Cardiovascular Science, London, United Kingdom.'}, {'ForeName': 'Menelaos', 'Initials': 'M', 'LastName': 'Pavlou', 'Affiliation': 'Department of Statistical Science, University College London, London, United Kingdom.'}, {'ForeName': 'Oliver T', 'Initials': 'OT', 'LastName': 'Watkinson', 'Affiliation': 'University College London Institute of Cardiovascular Science, London, United Kingdom.'}, {'ForeName': 'Alexandros', 'Initials': 'A', 'LastName': 'Protonotarios', 'Affiliation': 'University College London Institute of Cardiovascular Science, London, United Kingdom.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Moss', 'Affiliation': ""Barts Heart Centre, St Bartholomew's Hospital, Barts Health National Health Service Trust, West Smithfield, London, United Kingdom.""}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Hyland', 'Affiliation': 'Salisbury District Hospital, Salisbury, United Kingdom.'}, {'ForeName': 'Khadija', 'Initials': 'K', 'LastName': 'Rantell', 'Affiliation': 'University College London Institute of Neurology, London, United Kingdom.'}, {'ForeName': 'Antonis A', 'Initials': 'AA', 'LastName': 'Pantazis', 'Affiliation': 'Royal Brompton Hospital, London, United Kingdom.'}, {'ForeName': 'Maite', 'Initials': 'M', 'LastName': 'Tome', 'Affiliation': ""St George's Hospital, London, United Kingdom.""}, {'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'McKenna', 'Affiliation': 'University College London Institute of Cardiovascular Science, London, United Kingdom.'}, {'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'Frenneaux', 'Affiliation': 'University of East Anglia, Norwich Research Park, Norwich, United Kingdom.'}, {'ForeName': 'Rumana', 'Initials': 'R', 'LastName': 'Omar', 'Affiliation': 'Department of Statistical Science, University College London, London, United Kingdom.'}, {'ForeName': 'Perry M', 'Initials': 'PM', 'LastName': 'Elliott', 'Affiliation': 'University College London Institute of Cardiovascular Science, London, United Kingdom.'}]",JAMA cardiology,['10.1001/jamacardio.2018.4847'] 722,31158087,"Addition of Docetaxel to First-line Long-term Hormone Therapy in Prostate Cancer (STAMPEDE): Modelling to Estimate Long-term Survival, Quality-adjusted Survival, and Cost-effectiveness.","BACKGROUND Results from large randomised controlled trials have shown that adding docetaxel to the standard of care (SOC) for men initiating hormone therapy for prostate cancer (PC) prolongs survival for those with metastatic disease and prolongs failure-free survival for those without. To date there has been no formal assessment of whether funding docetaxel in this setting represents an appropriate use of UK National Health Service (NHS) resources. OBJECTIVE To assess whether administering docetaxel to men with PC starting long-term hormone therapy is cost-effective in a UK setting. DESIGN, SETTING, AND PARTICIPANTS We modelled health outcomes and costs in the UK NHS using data collected within the STAMPEDE trial, which enrolled men with high-risk, locally advanced metastatic or recurrent PC starting first-line hormone therapy. INTERVENTION SOC was hormone therapy for ≥2 yr and radiotherapy in some patients. Docetaxel (75mg/m 2 ) was administered alongside SOC for six three-weekly cycles. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS The model generated lifetime predictions of costs, changes in survival duration, quality-adjusted life years (QALYs), and incremental cost-effectiveness ratios (ICERs). RESULTS AND LIMITATIONS The model predicted that docetaxel would extend survival (discounted quality-adjusted survival) by 0.89 yr (0.51) for metastatic PC and 0.78 yr (0.39) for nonmetastatic PC, and would be cost-effective in metastatic PC (ICER £5514/QALY vs SOC) and nonmetastatic PC (higher QALYs, lower costs vs SOC). Docetaxel remained cost-effective in nonmetastatic PC when the assumption of no survival advantage was modelled. CONCLUSIONS Docetaxel is cost-effective among patients with nonmetastatic and metastatic PC in a UK setting. Clinicians should consider whether the evidence is now sufficiently compelling to support docetaxel use in patients with nonmetastatic PC, as the opportunity to offer docetaxel at hormone therapy initiation will be missed for some patients by the time more mature survival data are available. PATIENT SUMMARY Starting docetaxel chemotherapy alongside hormone therapy represents a good use of UK National Health Service resources for patients with prostate cancer that is high risk or has spread to other parts of the body.",2018,"The model generated lifetime predictions of costs, changes in survival duration, quality-adjusted life years (QALYs), and incremental cost-effectiveness ratios (ICERs). ","['enrolled men with high-risk, locally advanced metastatic or recurrent PC starting first-line hormone therapy', 'men with PC starting long-term', 'patients with prostate cancer', 'patients with nonmetastatic PC', 'patients with nonmetastatic and metastatic PC in a UK setting']","['docetaxel', 'Docetaxel to First-line Long-term Hormone Therapy', 'hormone therapy', 'Docetaxel', 'docetaxel chemotherapy alongside hormone therapy', 'SOC was hormone therapy for ≥2 yr and radiotherapy']","['survival duration, quality-adjusted life years (QALYs), and incremental cost-effectiveness ratios (ICERs', 'survival (discounted quality-adjusted survival']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy (procedure)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}]","[{'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy (procedure)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}]","[{'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0080071', 'cui_str': 'QALY'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}]",,0.0857722,"The model generated lifetime predictions of costs, changes in survival duration, quality-adjusted life years (QALYs), and incremental cost-effectiveness ratios (ICERs). ","[{'ForeName': 'Beth S', 'Initials': 'BS', 'LastName': 'Woods', 'Affiliation': 'Centre for Health Economics, University of York, York, UK. Electronic address: beth.woods@york.ac.uk.'}, {'ForeName': 'Eleftherios', 'Initials': 'E', 'LastName': 'Sideris', 'Affiliation': 'Centre for Health Economics, University of York, York, UK.'}, {'ForeName': 'Matthew R', 'Initials': 'MR', 'LastName': 'Sydes', 'Affiliation': 'MRC Clinical Trials Unit at UCL, Institute of Clinical Trials and Methodology, University College London, London, UK.'}, {'ForeName': 'Melissa R', 'Initials': 'MR', 'LastName': 'Gannon', 'Affiliation': 'MRC Clinical Trials Unit at UCL, Institute of Clinical Trials and Methodology, University College London, London, UK.'}, {'ForeName': 'Mahesh K B', 'Initials': 'MKB', 'LastName': 'Parmar', 'Affiliation': 'MRC Clinical Trials Unit at UCL, Institute of Clinical Trials and Methodology, University College London, London, UK.'}, {'ForeName': 'Mymoona', 'Initials': 'M', 'LastName': 'Alzouebi', 'Affiliation': 'Weston Park Hospital, Sheffield, UK.'}, {'ForeName': 'Gerhardt', 'Initials': 'G', 'LastName': 'Attard', 'Affiliation': 'The Institute of Cancer Research, London, UK; The Royal Marsden NHS Foundation Trust, London, UK.'}, {'ForeName': 'Alison J', 'Initials': 'AJ', 'LastName': 'Birtle', 'Affiliation': 'Rosemere Cancer Centre, Royal Preston Hospital, Preston, UK.'}, {'ForeName': 'Susannah', 'Initials': 'S', 'LastName': 'Brock', 'Affiliation': 'Dorset Cancer Centre, Poole Hospital NHS Foundation Trust, Poole, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Cathomas', 'Affiliation': 'Swiss Group for Clinical Cancer Research (SAKK), Bern, Switzerland; Kantonsspital Graubünden, Chur, Switzerland.'}, {'ForeName': 'Prabir R', 'Initials': 'PR', 'LastName': 'Chakraborti', 'Affiliation': 'Royal Derby Hospital, Derby, UK.'}, {'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'Cook', 'Affiliation': 'Gloucestershire Oncology Centre, Cheltenham, UK.'}, {'ForeName': 'William R', 'Initials': 'WR', 'LastName': 'Cross', 'Affiliation': 'Department of Urology, Leeds Teaching Hospitals NHS Trust, Leeds, UK.'}, {'ForeName': 'David P', 'Initials': 'DP', 'LastName': 'Dearnaley', 'Affiliation': 'The Institute of Cancer Research, London, UK; The Royal Marsden NHS Foundation Trust, London, UK.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Gale', 'Affiliation': 'Portsmouth Oncology Centre, Queen Alexandra Hospital, Portsmouth, UK.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Gibbs', 'Affiliation': 'Barking, Havering and Redbridge University Hospitals NHS Trust, Romford, UK.'}, {'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Graham', 'Affiliation': 'Beacon Centre, Musgrove Park Hospital, Taunton, UK.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Hughes', 'Affiliation': 'Mount Vernon Group, Mount Vernon Hospital, Northwood, UK.'}, {'ForeName': 'Rob J', 'Initials': 'RJ', 'LastName': 'Jones', 'Affiliation': 'University of Glasgow, UK.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Laing', 'Affiliation': ""St Luke's Cancer Centre, Royal Surrey NHS Trust, Guildford, UK.""}, {'ForeName': 'Malcolm D', 'Initials': 'MD', 'LastName': 'Mason', 'Affiliation': 'School of Medicine, Cardiff University, Cardiff, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Matheson', 'Affiliation': 'University of Wolverhampton, Wolverhampton, UK.'}, {'ForeName': 'Duncan B', 'Initials': 'DB', 'LastName': 'McLaren', 'Affiliation': 'Department of Oncology, Western General Hospital, Edinburgh, UK.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Millman', 'Affiliation': 'MRC Clinical Trials Unit at UCL, Institute of Clinical Trials and Methodology, University College London, London, UK.'}, {'ForeName': 'Joe M', 'Initials': 'JM', 'LastName': ""O'Sullivan"", 'Affiliation': ""Centre for Cancer Research and Cell Biology, Queen's University, Belfast, UK.""}, {'ForeName': 'Omi', 'Initials': 'O', 'LastName': 'Parikh', 'Affiliation': 'Department of Oncology, East Lancashire Hospitals NHS Trust, Burnley, UK.'}, {'ForeName': 'Christopher C', 'Initials': 'CC', 'LastName': 'Parker', 'Affiliation': 'The Royal Marsden NHS Foundation Trust, London, UK.'}, {'ForeName': 'Clive', 'Initials': 'C', 'LastName': 'Peedell', 'Affiliation': 'South Tees NHS Foundation Trust, Middlesbrough, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Protheroe', 'Affiliation': 'Department of Oncology, Churchill Hospital, Oxford, UK.'}, {'ForeName': 'Alastair W S', 'Initials': 'AWS', 'LastName': 'Ritchie', 'Affiliation': 'Gloucestershire Royal Hospital Foundation Trust, Gloucester, UK.'}, {'ForeName': 'Angus', 'Initials': 'A', 'LastName': 'Robinson', 'Affiliation': 'Sussex Cancer Centre, Royal Sussex County Hospital, Brighton, UK.'}, {'ForeName': 'J Martin', 'Initials': 'JM', 'LastName': 'Russell', 'Affiliation': 'Institute of Cancer Sciences, University of Glasgow, Glasgow, UK; Forth Valley Royal Hospital, Larbert, UK.'}, {'ForeName': 'Matthew S', 'Initials': 'MS', 'LastName': 'Simms', 'Affiliation': 'Hull and East Yorkshire Hospitals NHS Trust, Hull, UK.'}, {'ForeName': 'Narayanan N', 'Initials': 'NN', 'LastName': 'Srihari', 'Affiliation': 'Shrewsbury and Telford Hospitals NHS Trust, Shrewsbury, UK.'}, {'ForeName': 'Rajaguru', 'Initials': 'R', 'LastName': 'Srinivasan', 'Affiliation': 'Royal Devon & Exeter NHS Foundation Trust, Exeter, UK.'}, {'ForeName': 'John N', 'Initials': 'JN', 'LastName': 'Staffurth', 'Affiliation': 'Velindre Cancer Centre, Cardiff and School of Medicine, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Santhanam', 'Initials': 'S', 'LastName': 'Sundar', 'Affiliation': 'University of Nottingham, Nottingham, UK.'}, {'ForeName': 'George N', 'Initials': 'GN', 'LastName': 'Thalmann', 'Affiliation': 'Department of Urology, University Hospital Bern, Bern, Switzerland.'}, {'ForeName': 'Shaun', 'Initials': 'S', 'LastName': 'Tolan', 'Affiliation': 'Clatterbridge Cancer Centre, Birkenhead, UK.'}, {'ForeName': 'Anna T H', 'Initials': 'ATH', 'LastName': 'Tran', 'Affiliation': 'The Christie NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Tsang', 'Affiliation': 'Southend and Basildon Hospitals, Southend, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Wagstaff', 'Affiliation': 'Swansea University College of Medicine, Swansea, UK.'}, {'ForeName': 'Nicholas D', 'Initials': 'ND', 'LastName': 'James', 'Affiliation': 'Queen Elizabeth Hospital, Edgbaston, Birmingham, UK.'}, {'ForeName': 'Mark J', 'Initials': 'MJ', 'LastName': 'Sculpher', 'Affiliation': 'Centre for Health Economics, University of York, York, UK.'}]",European urology oncology,['10.1016/j.euo.2018.06.004'] 723,30844995,First Impressions Matter: How Initial Worries Influence Adherence to the Dapivirine Vaginal Ring.,"BACKGROUND In MTN-020/ASPIRE, a dapivirine vaginal ring effectiveness trial in sub-Saharan Africa, we assessed whether worries about ring use changed over time and were associated with adherence. METHODS Participants (N = 2585) were surveyed at baseline and follow-up about worries regarding daily ring use. First, they answered a question about general worries and then responded to 15 items covering specific worries. From a nested qualitative component (N = 214), we extracted themes related to ring worries and adherence. Seven months into the trial, aggregate adherence data were shared with study sites as part of an intervention that included counseling and social support. Nonadherence was defined as dapivirine plasma levels of ≤95 pg/mL. Mixed-effect logistic regression models were used to assess changes in ring worries and nonadherence from baseline to month 3 and later. RESULTS Worry about wearing the ring decreased from 29% at baseline to 4% at month 3 (P < 0.001), while having a specific worry decreased from 47% to 16% (P < 0.001). Among those enrolled before intervention, 29% with baseline worries were nonadherent at month 3 (95% confidence interval: 19% to 39%) compared to 14% without worries (95% confidence interval: 9% to 19%; P = 0.005); the difference persisted through month 6. There was no difference in nonadherence by baseline worry for those enrolled after intervention (P = 0.40). In the qualitative subset, initial ring anxieties reportedly subsided with self-experimentation and practice and the beneficial influence of the intervention. CONCLUSIONS Although worries may be an initial deterrent to correct ring use, intervening early by leveraging social influences from peers and clinicians should facilitate successful adoption and correct ring use.",2019,There was no difference in nonadherence by baseline worry for those enrolled after intervention (P = 0.40).,"['Participants (N = 2585) were surveyed at baseline and follow-up about worries regarding daily ring use', 'First Impressions Matter']",[],"['dapivirine plasma levels', 'nonadherence', 'Worry about wearing the ring', 'specific worry']","[{'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0233481', 'cui_str': 'Worried (finding)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C1260969', 'cui_str': 'Ring, device (physical object)'}, {'cui': 'C1947944', 'cui_str': 'Use'}]",[],"[{'cui': 'C1434916', 'cui_str': '4-((4-((2,4,6-trimethylphenyl)amino)pyrimidin-2-yl)amino)benzonitrile'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0233481', 'cui_str': 'Worried (finding)'}, {'cui': 'C1260969', 'cui_str': 'Ring, device (physical object)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}]",2585.0,0.0633857,There was no difference in nonadherence by baseline worry for those enrolled after intervention (P = 0.40).,"[{'ForeName': 'Ariane', 'Initials': 'A', 'LastName': 'van der Straten', 'Affiliation': ""RTI International, Women's Global Health Imperative (WGHI), San Francisco, CA.""}, {'ForeName': 'Erica N', 'Initials': 'EN', 'LastName': 'Browne', 'Affiliation': ""RTI International, Women's Global Health Imperative (WGHI), San Francisco, CA.""}, {'ForeName': 'Mary Kate', 'Initials': 'MK', 'LastName': 'Shapley-Quinn', 'Affiliation': ""RTI International, Women's Global Health Imperative (WGHI), San Francisco, CA.""}, {'ForeName': 'Elizabeth R', 'Initials': 'ER', 'LastName': 'Brown', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Statistical Center for HIV/AIDS Research and Prevention, Seattle, WA.'}, {'ForeName': 'Krishnaveni', 'Initials': 'K', 'LastName': 'Reddy', 'Affiliation': 'Wits Reproductive Health and HIV Institute, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Scheckter', 'Affiliation': 'FHI 360, Durham, NC.'}, {'ForeName': 'Lydia', 'Initials': 'L', 'LastName': 'Soto-Torres', 'Affiliation': 'NIAID/DAIDS, Bethesda, MD.'}, {'ForeName': 'Thesla', 'Initials': 'T', 'LastName': 'Palanee-Phillips', 'Affiliation': 'Wits Reproductive Health and HIV Institute, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Jared M', 'Initials': 'JM', 'LastName': 'Baeten', 'Affiliation': 'Department of Global Health, Medicine, and Epidemiology, University of Washington, Seattle, WA.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Mensch', 'Affiliation': 'Population Council, New York, NY.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of acquired immune deficiency syndromes (1999),['10.1097/QAI.0000000000002028'] 724,30592549,"Impact of Insulin Tregopil and Its Permeation Enhancer on Pharmacokinetics of Metformin in Healthy Volunteers: Randomized, Open-Label, Placebo-Controlled, Crossover Study.","Oral insulin tregopil (IN-105; a new drug under development) may be coadministered with oral antidiabetic drugs, such as metformin in patients with type 2 diabetes mellitus for optimal glycemic control. IN-105 has sodium caprate excipient, a permeation enhancer, for enhancing absorption in the stomach and increasing bioavailability via an oral route. Sodium caprate may increase bioavailability of metformin by a similar mechanism. Therefore, it was necessary to study the effect of IN-105 on pharmacokinetics (PKs) of metformin. In this randomized, open-label, cross-over study, metformin was administered to healthy volunteers receiving IN-105/placebo under fed/fasting conditions. The 90% confidence interval (CI) of the geometric mean ratio of the area under the curve from time zero to infinity (AUC 0-inf ; fasting and fed) and peak plasma concentration (C max ; fed) of metformin were within 0.80-1.25 acceptance range. Under fasting conditions, the upper bound margin of C max was just beyond this range (i.e., 1.27) and was concluded as functionally not relevant. There was no clinically significant effect of sodium caprate/IN-105 on PKs of metformin under fasting/fed conditions, and it was safe.",2019,"There was no clinically significant effect of sodium caprate/IN-105 on PKs of metformin under fasting/fed conditions, and it was safe.","['healthy volunteers receiving IN-105/placebo under fed/fasting conditions', 'Healthy Volunteers', 'patients with type 2 diabetes mellitus for optimal glycemic control']","['metformin', 'Oral insulin tregopil (IN-105', 'Open-Label, Placebo', 'Metformin', 'Sodium caprate']","['bioavailability of metformin', 'peak plasma concentration']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0142815', 'cui_str': 'decanoic acid, sodium salt'}]","[{'cui': 'C0005508', 'cui_str': 'Bioavailability'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",,0.0247629,"There was no clinically significant effect of sodium caprate/IN-105 on PKs of metformin under fasting/fed conditions, and it was safe.","[{'ForeName': 'Anand', 'Initials': 'A', 'LastName': 'Khedkar', 'Affiliation': 'Biocon Research Ltd.,, Bengaluru, Karnataka, India.'}, {'ForeName': 'Harold', 'Initials': 'H', 'LastName': 'Lebovitz', 'Affiliation': 'State University of New York Health Science Center at Brooklyn, Brooklyn, New York, USA.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Fleming', 'Affiliation': 'Kinexum, Harpers Ferry, West Virginia, USA.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Cherrington', 'Affiliation': 'Vanderbilt University School of Medicine, Nashville, Tennessee, USA.'}, {'ForeName': 'Vinu', 'Initials': 'V', 'LastName': 'Jose', 'Affiliation': 'Biocon Research Ltd.,, Bengaluru, Karnataka, India.'}, {'ForeName': 'Sandeep N', 'Initials': 'SN', 'LastName': 'Athalye', 'Affiliation': 'Biocon Research Ltd.,, Bengaluru, Karnataka, India.'}, {'ForeName': 'Ashwini', 'Initials': 'A', 'LastName': 'Vishweswaramurthy', 'Affiliation': 'Biocon Research Ltd.,, Bengaluru, Karnataka, India.'}]",Clinical and translational science,['10.1111/cts.12609'] 725,31208686,Could Treatment Matching Patients' Beliefs About Depression Improve Outcomes?,"Patients' beliefs about depression and expectations for treatment can influence outcomes of major depressive disorder (MDD) treatments. We hypothesized that patients with weaker biological beliefs (less endorsement of [a] biochemical causes and [b] need for medication) and more optimistic treatment expectations (greater improvement and shorter time to improvement), have better outcomes in cognitive therapy (CT). Outpatients with recurrent MDD who received acute-phase CT (N = 152), and a subset of partial or unstable responders (N = 51) randomized to 8 months of continuation CT or fluoxetine with clinical management, completed repeated measures of beliefs, expectations, and depression. As hypothesized, patients with weaker biological beliefs about depression, and patients who expected a shorter time to improvement, experienced greater change in depressive symptoms and more frequent response to acute-phase CT. Moreover, responders who received continuation treatment better matched to their biological beliefs (i.e., responders with weaker biological beliefs about depression who received continuation CT, or responders with stronger biological beliefs about depression who received continuation fluoxetine) had fewer depressive symptoms and less relapse/recurrence by 32 months after acute-phase CT than did responders who received mismatched continuation treatment. Specific screening and/or intervention targeting patients' biological beliefs about depression could increase CT efficacy.",2019,"As hypothesized, patients with weaker biological beliefs about depression, and patients who expected a shorter time to improvement, experienced greater change in depressive symptoms and more frequent response to acute-phase CT.","['Outpatients with recurrent MDD who received acute-phase CT (N = 152), and a subset of partial or unstable responders']","['continuation fluoxetine', 'continuation CT or fluoxetine']","['CT efficacy', 'relapse/recurrence', 'depressive symptoms']","[{'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0439557', 'cui_str': 'Acute phase (qualifier value)'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C0443343', 'cui_str': 'Unstable status (qualifier value)'}]","[{'cui': 'C0016365', 'cui_str': 'Fluoxetine'}]","[{'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}]",51.0,0.0179521,"As hypothesized, patients with weaker biological beliefs about depression, and patients who expected a shorter time to improvement, experienced greater change in depressive symptoms and more frequent response to acute-phase CT.","[{'ForeName': 'Jeffrey R', 'Initials': 'JR', 'LastName': 'Vittengl', 'Affiliation': 'Truman State University. Electronic address: vittengl@truman.edu.'}, {'ForeName': 'Lee Anna', 'Initials': 'LA', 'LastName': 'Clark', 'Affiliation': 'University of Notre Dame.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Thase', 'Affiliation': 'Perelman School of Medicine, University of Pennsylvania.'}, {'ForeName': 'Robin B', 'Initials': 'RB', 'LastName': 'Jarrett', 'Affiliation': 'The University of Texas Southwestern Medical Center. Electronic address: Robin.Jarrett@UTSouthwestern.edu.'}]",Behavior therapy,['10.1016/j.beth.2018.11.007'] 726,31208690,Pilot Randomized Trial of a Self-Help Behavioral Activation Mobile App for Utilization in Primary Care.,"Mobile technologies can be leveraged to meet the need for evidence-based psychological depression treatment via primary care. The purpose of the present study was to preliminarily examine the feasibility and efficacy of a self-help brief behavioral activation mobile application (app; ""Moodivate"") for depressive symptoms among adults treated via primary care. Participants (N = 52) were recruited from primary care practices between January and December 2017 and were randomized 2:2:1 to receive (a) Moodivate, (b) an active control cognitive-behavioral therapy-based mobile app (""MoodKit""), or (c) treatment as usual (TAU; no app). Participants completed assessments of depressive symptoms weekly for 8 weeks. App analytics data were captured to examine Moodivate feasibility (analytics unavailable for control app). Moodivate participants on average had 46.76 (SD = 30.10) app sessions throughout the trial duration, spent 3.50 (2.76) minutes using the app per session, and spent 120.76 (101.02) minutes using the app in total throughout the trial. Nearly 70% of Moodivate participants continued to use the app 1 month after trial enrollment and 50% at the end of the 8-week follow-up period. A generalized estimating equation model examining change in depressive symptoms over time by treatment condition indicated a significant interaction between time and treatment condition (χ 2 = 42.21, df = 14, p < .001). As compared to TAU, participants in both app conditions evidenced significant decreases in depressive symptoms over time, and these treatment gains were sustained across the trial period. These results preliminarily indicate feasibility of Moodivate as well as efficacy of both Moodivate and MoodKit for the treatment of depression among adults recruited via primary care. Future studies should focus on larger-scale examinations of treatment efficacy and effectiveness across primary care settings.",2019,"A generalized estimating equation model examining change in depressive symptoms over time by treatment condition indicated a significant interaction between time and treatment condition (χ 2 = 42.21, df = 14, p < .001).","['adults recruited via primary care', 'Primary Care', 'adults treated via primary care', 'Participants (N = 52) were recruited from primary care practices between January and December 2017']","['self-help brief behavioral activation mobile application (app; ""Moodivate', 'Self-Help Behavioral Activation Mobile App', 'active control cognitive-behavioral therapy-based mobile app (""MoodKit""), or (c) treatment as usual (TAU; no app']",['depressive symptoms'],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C1292734', 'cui_str': 'Treats'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1720655', 'cui_str': 'Tau'}]","[{'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}]",52.0,0.0406973,"A generalized estimating equation model examining change in depressive symptoms over time by treatment condition indicated a significant interaction between time and treatment condition (χ 2 = 42.21, df = 14, p < .001).","[{'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Dahne', 'Affiliation': 'Medical University of South Carolina. Electronic address: dahne@musc.edu.'}, {'ForeName': 'C W', 'Initials': 'CW', 'LastName': 'Lejuez', 'Affiliation': 'University of Kansas.'}, {'ForeName': 'Vanessa A', 'Initials': 'VA', 'LastName': 'Diaz', 'Affiliation': 'Medical University of South Carolina.'}, {'ForeName': 'Marty S', 'Initials': 'MS', 'LastName': 'Player', 'Affiliation': 'Medical University of South Carolina.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Kustanowitz', 'Affiliation': 'MountainPass Technology.'}, {'ForeName': 'Julia W', 'Initials': 'JW', 'LastName': 'Felton', 'Affiliation': 'Michigan State University.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Carpenter', 'Affiliation': 'Medical University of South Carolina.'}]",Behavior therapy,['10.1016/j.beth.2018.12.003'] 727,31087723,Pharmacogenetic role of dopamine transporter (SLC6A3) variation on response to disulfiram treatment for cocaine addiction.,"BACKGROUND AND OBJECTIVES Disulfiram has been beneficial in treating cocaine addiction in several studies. Patients with two SLC6A3 (DAT1) rs28363170 10-repeat alleles who have with genetically high dopamine transporter (DAT) levels may benefit from increased dopamine levels resulting from disulfiram treatment. METHODS After stabilization for 2 weeks on methadone, 70 cocaine and opioid codependent patients were randomized into disulfiram and placebo groups for 12 weeks of treatment. We genotyped the SLC6A3 (DAT1) 40 bp 3'-untranslated region variable number tandem repeat variant and evaluated its role in moderating disulfiram efficacy for cocaine dependence. RESULTS Among the 10,10-repeat genotype group, cocaine-positive urines dropped from 78% to 48% and from 80% to 75% among the 9-repeat carrier group in the disulfiram group (P = 0.0001, with an effect size of 0.09). No difference was observed in cocaine-positive urines in the placebo group between the 10,10-repeat genotype and the 9-allele carrier patients. CONCLUSIONS AND SCIENTIFIC SIGNIFICANCE We found that patients with genetically higher DAT levels had better treatment outcomes with disulfiram pharmacotherapy of cocaine dependence than those with lower DAT levels. (Am J Addict 2019;28:311-317).",2019,"No difference was observed in cocaine-positive urines in the placebo group between the 10,10-repeat genotype and the 9-allele carrier patients. ",['Patients with two SLC6A3 (DAT1) rs28363170 10-repeat alleles who have with genetically high dopamine transporter (DAT) levels may benefit from increased dopamine levels resulting from disulfiram treatment'],"['methadone', 'disulfiram and placebo', 'placebo']",['cocaine-positive urines'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C0002085', 'cui_str': 'Allelomorphs'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0114838', 'cui_str': 'Dopamine Plasma Membrane Transport Proteins'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0013030', 'cui_str': 'Dopamine'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0012772', 'cui_str': 'Disulfiram'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0025605', 'cui_str': 'Methadone'}, {'cui': 'C0012772', 'cui_str': 'Disulfiram'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0009170', 'cui_str': 'Cocaine'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0042037'}]",,0.0537507,"No difference was observed in cocaine-positive urines in the placebo group between the 10,10-repeat genotype and the 9-allele carrier patients. ","[{'ForeName': 'June P', 'Initials': 'JP', 'LastName': 'Kampangkaew', 'Affiliation': 'Menninger Department of Psychiatry and Behavioral Sciences, Baylor College of Medicine, Houston, Texas.'}, {'ForeName': 'Catherine J', 'Initials': 'CJ', 'LastName': 'Spellicy', 'Affiliation': 'Menninger Department of Psychiatry and Behavioral Sciences, Baylor College of Medicine, Houston, Texas.'}, {'ForeName': 'Ellen M', 'Initials': 'EM', 'LastName': 'Nielsen', 'Affiliation': 'Menninger Department of Psychiatry and Behavioral Sciences, Baylor College of Medicine, Houston, Texas.'}, {'ForeName': 'Mark J', 'Initials': 'MJ', 'LastName': 'Harding', 'Affiliation': 'Menninger Department of Psychiatry and Behavioral Sciences, Baylor College of Medicine, Houston, Texas.'}, {'ForeName': 'An', 'Initials': 'A', 'LastName': 'Ye', 'Affiliation': 'Menninger Department of Psychiatry and Behavioral Sciences, Baylor College of Medicine, Houston, Texas.'}, {'ForeName': 'Sara C', 'Initials': 'SC', 'LastName': 'Hamon', 'Affiliation': 'Statistical and Genetic Consulting LLC, Darien, Connecticut.'}, {'ForeName': 'Thomas R', 'Initials': 'TR', 'LastName': 'Kosten', 'Affiliation': 'Menninger Department of Psychiatry and Behavioral Sciences, Baylor College of Medicine, Houston, Texas.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Nielsen', 'Affiliation': 'Menninger Department of Psychiatry and Behavioral Sciences, Baylor College of Medicine, Houston, Texas.'}]",The American journal on addictions,['10.1111/ajad.12891'] 728,31141104,P2Y12 Inhibitor Switching in Response to Routine Notification of CYP2C19 Clopidogrel Metabolizer Status Following Acute Coronary Syndromes.,"Importance Physician behavior in response to knowledge of a patient's CYP2C19 clopidogrel metabolizer status is unknown. Objective To investigate the association of mandatory reporting of CYP2C19 pharmacogenomic testing, provided to investigators with no direct recommendations on how to use these results, with changes in P2Y12 inhibitor use, particularly clopidogrel, in the Randomized Trial to Compare the Safety of Rivaroxaban vs Aspirin in Addition to Either Clopidogrel or Ticagrelor in Acute Coronary Syndrome (GEMINI-ACS-1) clinical trial. Design, Setting, and Participants The GEMINI-ACS-1 trial compared rivaroxaban, 2.5 mg twice daily, with aspirin, 100 mg daily, plus open-label clopidogrel or ticagrelor (provided), in patients with recent acute coronary syndromes (ACS). The trial included 371 clinical centers in 21 countries and 3037 patients with ACS. Data were analyzed between May 2017 and February 2019. Interventions Investigators were required to prestipulate their planned response to CYP2C19 metabolizer status. In response to a regulatory mandate, results for all patients were reported to investigators approximately 1 week after randomization. Main Outcomes and Measures Reasons for switching P2Y12 inhibitors and occurrence of bleeding and ischemic events were collected. Results Of 3037 patients enrolled (mean [SD] age, 62.8 [9.0] years; 2275 men [74.9%], and 2824 white race/ethnicity [93.0%]), investigators initially treated 1704 (56.1%) with ticagrelor and 1333 (43.9%) with clopidogrel. Investigators prestipulated that they would use CYP2C19 metabolizer status to change P2Y12 inhibitor in 48.5% of genotyped clopidogrel-treated patients (n = 642 of 1324) and 5.5% of genotyped ticagrelor-treated patients (n = 93 of 1692). P2Y12 inhibitor switching for any reason occurred in 197 patients and was more common in patients treated with ticagrelor (146 of 1704 [8.6%]) compared with clopidogrel (51 of 1333 [3.8%]). Of patients initially treated with ticagrelor, only 1 (0.1% overall; 0.7% of all who switched) was switched based on CYP2C19 status. Of patients initially treated with clopidogrel, 23 (1.7% overall,;45.1% of all who switched) were switched owing to metabolizer status. Of 48 patients (3.6%) with reduced metabolizer status treated initially with clopidogrel, 15 (31.3%) were switched based on metabolizer status, including 48.1% (13 of 27) in which switching was prestipulated. Conclusions and Relevance Physicians were evenly split on how to respond to knowledge of CYP2C19 metabolizer status in clopidogrel-treated patients. Mandatory provision of this information rarely prompted P2Y12 inhibitor switching overall, including a minority of patients with reduced metabolizer status. These findings highlight the clinical equipoise among physicians regarding use of this information and the reluctance to use information from routine genotyping in the absence of definitive clinical trial data demonstrating the efficacy of this approach. Clinical Trial Registration ClinicalTrials.gov identifier: NCT02293395.",2019,"Of patients initially treated with clopidogrel, 23 (1.7% overall,;45.1% of all who switched) were switched owing to metabolizer status.","['371 clinical centers in 21 countries and 3037 patients with ACS', 'patients with recent acute coronary syndromes (ACS', '3037 patients enrolled (mean [SD] age, 62.8 [9.0] years; 2275 men [74.9%], and 2824 white race/ethnicity [93.0%]), investigators initially treated 1704 (56.1%) with ticagrelor and 1333 (43.9%) with', '48 patients (3.6%) with reduced metabolizer status treated initially with', 'Acute Coronary Syndrome']","['CYP2C19 Clopidogrel Metabolizer', 'rivaroxaban', 'ticagrelor', 'Clopidogrel or Ticagrelor', 'aspirin, 100 mg daily, plus open-label clopidogrel or ticagrelor', 'Rivaroxaban vs Aspirin', 'clopidogrel']",['Measures\n\n\nReasons for switching P2Y12 inhibitors and occurrence of bleeding and ischemic events'],"[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C0948089', 'cui_str': 'Acute Coronary Syndrome'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C3853635', 'cui_str': 'Race (observable entity)'}, {'cui': 'C0243103', 'cui_str': 'ethnicity'}, {'cui': 'C0035173', 'cui_str': 'Investigators'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C4517694', 'cui_str': '3.6 (qualifier value)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}]","[{'cui': 'C3714749', 'cui_str': ""S-Mephenytoin 4'-Hydroxylase""}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C1739768', 'cui_str': 'rivaroxaban'}, {'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}]","[{'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0392360', 'cui_str': 'Reason for (attribute)'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0475224', 'cui_str': 'Ischemic (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}]",3037.0,0.0356846,"Of patients initially treated with clopidogrel, 23 (1.7% overall,;45.1% of all who switched) were switched owing to metabolizer status.","[{'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Povsic', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina.'}, {'ForeName': 'E Magnus', 'Initials': 'EM', 'LastName': 'Ohman', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina.'}, {'ForeName': 'Matthew T', 'Initials': 'MT', 'LastName': 'Roe', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'White', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina.'}, {'ForeName': 'Frank W', 'Initials': 'FW', 'LastName': 'Rockhold', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina.'}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Montalescot', 'Affiliation': 'Sorbonne Université, ACTION Study Group, Institut de Cardiologie, Pitié-Salpêtrière Hospital, Paris, France.'}, {'ForeName': 'Jan H', 'Initials': 'JH', 'LastName': 'Cornel', 'Affiliation': 'Department of Cardiology, Noordwest Ziekenhuisgroep, Alkmaar and Dutch Network for Cardiovascular Research, the Netherlands.'}, {'ForeName': 'Jose C', 'Initials': 'JC', 'LastName': 'Nicolau', 'Affiliation': 'Insituto do Coracao, Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'P Gabriel', 'Initials': 'PG', 'LastName': 'Steg', 'Affiliation': 'DHU FIRE, Université Paris-Diderot, AP-HP and Inserm U-1148, Paris, France.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'James', 'Affiliation': 'Department of Medical Sciences and Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Bode', 'Affiliation': 'University of Freiburg, Faculty of Medicine, Internal Medicine III, Freiburg, Germany.'}, {'ForeName': 'Robert C', 'Initials': 'RC', 'LastName': 'Welsh', 'Affiliation': 'Mazankowski Alberta Heart Institute and University of Alberta, Edmonton, Alberta, Canada.'}, {'ForeName': 'Alexei N', 'Initials': 'AN', 'LastName': 'Plotnikov', 'Affiliation': 'Janssen Research and Development, Raritan, New Jersey.'}, {'ForeName': 'Hardi', 'Initials': 'H', 'LastName': 'Mundl', 'Affiliation': 'Bayer AG, Wuppertal, Germany.'}, {'ForeName': 'C Michael', 'Initials': 'CM', 'LastName': 'Gibson', 'Affiliation': 'PERFUSE Study Group, Beth Israel Deaconess Hospital, Harvard Medical School, Boston, Massachusetts.'}]",JAMA cardiology,['10.1001/jamacardio.2019.1510'] 729,31071541,Hippocampal volume and depression among young children.,"Clinical depression can occur in young children as early as age three. This very early onset variant of depression shows the same clinical features with developmental adjustments as depression that onsets later in life. One robust neural feature of adult depression is reduced hippocampal volume. We measured hippocampal volume in a sample of 35 children aged 4-7 who were either in a clinical trial for preschool onset depression or were recruited from the community. We used T1 MPRAGE acquisitions on a Siemen's Scanner, with Freesurfer 5.3 used to segment the hippocampus. Depression was measured using the K-SADS early childhood (K-SADS-EC) to create a dimensional depression severity score and the Child Behavior Checklist (CBCL) Depression T-Score. Multilevel models indicated that greater depression severity as measured by either the CBCL Depression Score or the K-SADS-EC was associated with lower hippocampal volume, even controlling for total gray matter, maternal depression, income-to-needs ratio, and stressful life events. These data indicate evidence for reduced hippocampal volume among children with PO-MDD who were more severely depressed. Findings are consistent with the idea that hippocampal volume reductions are an early occurring associated neural marker of MDD, particularly for more severe depression.",2019,We measured hippocampal volume in a sample of 35 children aged 4-7 who were either in a clinical trial for preschool onset depression or were recruited from the community.,"['young children', '35 children aged 4-7 who were either in a clinical trial for preschool onset depression or were recruited from the community', 'children with PO-MDD']",[],"['CBCL Depression Score', 'Hippocampal volume and depression', 'total gray matter, maternal depression, income-to-needs ratio, and stressful life events', 'Depression', 'hippocampal volume', 'Depression T-Score', 'dimensional depression severity score and the Child Behavior Checklist (CBCL']","[{'cui': 'C0337547', 'cui_str': 'Younger child (person)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0009462', 'cui_str': 'Community'}]",[],"[{'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0018220', 'cui_str': 'Gray Matter'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0557155', 'cui_str': 'Life event observable'}, {'cui': 'C3854607', 'cui_str': 'T score'}, {'cui': 'C0457451', 'cui_str': 'Severity score (qualifier value)'}, {'cui': 'C0008065', 'cui_str': 'Child Behavior'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}]",35.0,0.0426159,We measured hippocampal volume in a sample of 35 children aged 4-7 who were either in a clinical trial for preschool onset depression or were recruited from the community.,"[{'ForeName': 'Deanna M', 'Initials': 'DM', 'LastName': 'Barch', 'Affiliation': 'Department of Psychological & Brain Sciences, Washington University in St. Louis, USA; Department of Psychiatry, Washington University in St. Louis, USA; Department of Radiology, Washington University in St. Louis, USA. Electronic address: dbarch@wustl.edu.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Tillman', 'Affiliation': 'Department of Psychiatry, Washington University in St. Louis, USA.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Kelly', 'Affiliation': 'Department of Psychiatry, Washington University in St. Louis, USA.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Whalen', 'Affiliation': 'Department of Psychiatry, Washington University in St. Louis, USA.'}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Gilbert', 'Affiliation': 'Department of Psychiatry, Washington University in St. Louis, USA.'}, {'ForeName': 'Joan L', 'Initials': 'JL', 'LastName': 'Luby', 'Affiliation': 'Department of Psychiatry, Washington University in St. Louis, USA.'}]",Psychiatry research. Neuroimaging,['10.1016/j.pscychresns.2019.04.012'] 730,30379683,Efficacy and Effectiveness of Advanced Hearing Aid Directional and Noise Reduction Technologies for Older Adults With Mild to Moderate Hearing Loss.,"OBJECTIVES The purpose of the present study was to investigate the laboratory efficacy and real-world effectiveness of advanced directional microphones (DM) and digital noise reduction (NR) algorithms (i.e., premium DM/NR features) relative to basic-level DM/NR features of contemporary hearing aids (HAs). The study also examined the effect of premium HAs relative to basic HAs and the effect of DM/NR features relative to no features. DESIGN Fifty-four older adults with mild-to-moderate hearing loss completed a single-blinded crossover trial. Two HA models, one a less-expensive, basic-level device (basic HA) and the other a more-expensive, advanced-level device (premium HA), were used. The DM/NR features of the basic HAs (i.e., basic features) were adaptive DMs and gain-reduction NR with fewer channels. In contrast, the DM/NR features of the premium HAs (i.e., premium features) included adaptive DMs and gain-reduction NR with more channels, bilateral beamformers, speech-seeking DMs, pinna-simulation directivity, reverberation reduction, impulse NR, wind NR, and spatial NR. The trial consisted of four conditions, which were factorial combinations of HA model (premium versus basic) and DM/NR feature status (on versus off). To blind participants regarding the HA technology, no technology details were disclosed and minimal training on how to use the features was provided. In each condition, participants wore bilateral HAs for 5 weeks. Outcomes regarding speech understanding, listening effort, sound quality, localization, and HA satisfaction were measured using laboratory tests, retrospective self-reports (i.e., standardized questionnaires), and in-situ self-reports (i.e., self-reports completed in the real world in real time). A smartphone-based ecological momentary assessment system was used to collect in-situ self-reports. RESULTS Laboratory efficacy data generally supported the benefit of premium DM/NR features relative to basic DM/NR, premium HAs relative to basic HAs, and DM/NR features relative to no DM/NR in improving speech understanding and localization performance. Laboratory data also indicated that DM/NR features could improve listening effort and sound quality compared with no features for both basic- and premium-level HAs. For real-world effectiveness, in-situ self-reports first indicated that noisy or very noisy situations did not occur very often in participants' daily lives (10.9% of the time). Although both retrospective and in-situ self-reports indicated that participants were more satisfied with HAs equipped with DM/NR features than without, there was no strong evidence to support the benefit of premium DM/NR features and premium HAs over basic DM/NR features and basic HAs, respectively. CONCLUSIONS Although premium DM/NR features and premium HAs outperformed their basic-level counterparts in well-controlled laboratory test conditions, the benefits were not observed in the real world. In contrast, the effect of DM/NR features relative to no features was robust both in the laboratory and in the real world. Therefore, the present study suggests that although both premium and basic DM/NR technologies evaluated in the study have the potential to improve HA outcomes, older adults with mild-to-moderate hearing loss are unlikely to perceive the additional benefits provided by the premium DM/NR features in their daily lives. Limitations concerning the study's generalizability (e.g., participant's lifestyle) are discussed.",2019,Laboratory data also indicated that DM/NR features could improve listening effort and sound quality compared with no features for both basic- and premium-level HAs.,"['Fifty-four older adults with mild-to-moderate hearing loss completed a single-blinded crossover trial', 'Older Adults With Mild to Moderate Hearing Loss', 'older adults with mild-to-moderate hearing loss']","['Advanced Hearing Aid Directional and Noise Reduction Technologies', 'advanced directional microphones (DM) and digital noise reduction (NR) algorithms', 'smartphone-based ecological momentary assessment system']","['speech understanding, listening effort, sound quality, localization, and HA satisfaction', 'laboratory tests, retrospective self-reports (i.e., standardized questionnaires), and in-situ self-reports (i.e., self-reports completed in the real world in real time', 'Efficacy and Effectiveness', 'listening effort and sound quality']","[{'cui': 'C4517807', 'cui_str': 'Fifty-four'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1852284', 'cui_str': 'Mild to moderate hearing loss'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0150097', 'cui_str': 'Crossover Trials'}]","[{'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0018768', 'cui_str': 'Hearing Aids'}, {'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C1709026', 'cui_str': 'Microphone'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray (qualifier value)'}, {'cui': 'C0002045'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C4277684', 'cui_str': 'Ecological Momentary Assessment'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}]","[{'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0004339', 'cui_str': 'Auscultation'}, {'cui': 'C1293120', 'cui_str': 'Sounding'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0475264', 'cui_str': 'Localization - action (qualifier value)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0022885', 'cui_str': 'Laboratory test (procedure)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0444498', 'cui_str': 'In situ (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}]",54.0,0.051581,Laboratory data also indicated that DM/NR features could improve listening effort and sound quality compared with no features for both basic- and premium-level HAs.,"[{'ForeName': 'Yu-Hsiang', 'Initials': 'YH', 'LastName': 'Wu', 'Affiliation': 'Department of Communication Sciences and Disorders, The University of Iowa, Iowa City, Iowa, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Stangl', 'Affiliation': 'Department of Communication Sciences and Disorders, The University of Iowa, Iowa City, Iowa, USA.'}, {'ForeName': 'Octav', 'Initials': 'O', 'LastName': 'Chipara', 'Affiliation': 'Department of Computer Science, The University of Iowa, Iowa City, Iowa, USA.'}, {'ForeName': 'Syed Shabih', 'Initials': 'SS', 'LastName': 'Hasan', 'Affiliation': 'Department of Computer Science, The University of Iowa, Iowa City, Iowa, USA.'}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'DeVries', 'Affiliation': 'Department of Biostatistics, The University of Iowa, Iowa City, Iowa, USA.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Oleson', 'Affiliation': 'Department of Biostatistics, The University of Iowa, Iowa City, Iowa, USA.'}]",Ear and hearing,['10.1097/AUD.0000000000000672'] 731,30832542,Audiology Telemedicine Evaluations: Potential Expanded Applications.,"There is underutilization of cochlear implants with delays in implantation linked to distance from implant centers. Telemedicine could connect cochlear implant specialists with patients in rural locations. We piloted telemedicine cochlear implant testing in a small study, largely composed of normal-hearing volunteers to trial this new application of teleaudiology technology. Thirteen subjects (8 with normal hearing and 5 with hearing loss ranging from mild to profound) underwent a traditional cochlear implant evaluation in person and then via telemedicine technology. Routine audiometry, word recognition testing, and Arizona Biological Test (AzBio) and consonant-nucleus-consonant (CNC) testing were performed. Mean (SD) percent difference in AzBio between in-person and remote testing was 1.7% (2.06%). Pure tone average (PTA), speech reception threshold (SRT), and word recognition were similar between methods. CNC testing showed a mean (SD) difference of 6.8% (10.2%) between methods. Testing conditions were acceptable to audiologists and subjects. Further study to validate this method in cochlear implant candidates and a larger population is warranted.",2019,"Pure tone average (PTA), speech reception threshold (SRT), and word recognition were similar between methods.","['Thirteen subjects (8 with normal hearing and 5 with hearing loss ranging from mild to profound', 'patients in rural locations']","['Telemedicine', 'traditional cochlear implant evaluation in person and then via telemedicine technology']","['Routine audiometry, word recognition testing, and Arizona Biological Test (AzBio) and consonant-nucleus-consonant (CNC) testing', 'Pure tone average (PTA), speech reception threshold (SRT), and word recognition']","[{'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0439808', 'cui_str': 'Profundis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0450429', 'cui_str': 'Location (attribute)'}]","[{'cui': 'C0162648', 'cui_str': 'Telemedicine'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0009199', 'cui_str': 'Auditory Prosthesis'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0039421', 'cui_str': 'Technology'}]","[{'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0004286', 'cui_str': 'Audiometry'}, {'cui': 'C0524637', 'cui_str': 'Recognition (Psychology)'}, {'cui': 'C0003787', 'cui_str': 'Arizona'}, {'cui': 'C4553887', 'cui_str': 'Biologic Drugs'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0007610', 'cui_str': 'Cell Nucleus'}, {'cui': 'C0234742', 'cui_str': 'Speech reception threshold (observable entity)'}]",13.0,0.0648386,"Pure tone average (PTA), speech reception threshold (SRT), and word recognition were similar between methods.","[{'ForeName': 'Kyle T', 'Initials': 'KT', 'LastName': 'Fletcher', 'Affiliation': '1 Department of Otolaryngology-Head and Neck Surgery, University of Kentucky Medical Center, Lexington, Kentucky, USA.'}, {'ForeName': 'Frank W', 'Initials': 'FW', 'LastName': 'Dicken', 'Affiliation': '2 University of Kentucky College of Medicine, Lexington, Kentucky, USA.'}, {'ForeName': 'Margaret M', 'Initials': 'MM', 'LastName': 'Adkins', 'Affiliation': '1 Department of Otolaryngology-Head and Neck Surgery, University of Kentucky Medical Center, Lexington, Kentucky, USA.'}, {'ForeName': 'Trey A', 'Initials': 'TA', 'LastName': 'Cline', 'Affiliation': '1 Department of Otolaryngology-Head and Neck Surgery, University of Kentucky Medical Center, Lexington, Kentucky, USA.'}, {'ForeName': 'Beth N', 'Initials': 'BN', 'LastName': 'McNulty', 'Affiliation': '1 Department of Otolaryngology-Head and Neck Surgery, University of Kentucky Medical Center, Lexington, Kentucky, USA.'}, {'ForeName': 'Jennifer B', 'Initials': 'JB', 'LastName': 'Shinn', 'Affiliation': '1 Department of Otolaryngology-Head and Neck Surgery, University of Kentucky Medical Center, Lexington, Kentucky, USA.'}, {'ForeName': 'Matthew L', 'Initials': 'ML', 'LastName': 'Bush', 'Affiliation': '1 Department of Otolaryngology-Head and Neck Surgery, University of Kentucky Medical Center, Lexington, Kentucky, USA.'}]",Otolaryngology--head and neck surgery : official journal of American Academy of Otolaryngology-Head and Neck Surgery,['10.1177/0194599819835541'] 732,30570525,Retention in Care Trajectories of HIV-Positive Individuals Participating in a Universal Test-and-Treat Program in Rural South Africa (ANRS 12249 TasP Trial).,"OBJECTIVE To study retention in care (RIC) trajectories and associated factors in patients eligible for antiretroviral therapy (ART) in a universal test-and-treat setting (TasP trial, South Africa, 2012-2016). DESIGN A cluster-randomized trial whereby individuals identified HIV positive after home-based testing were invited to initiate ART immediately (intervention) or following national guidelines (control). METHODS Exiting care was defined as ≥3 months late for a clinic appointment, transferring elsewhere, or death. Group-based trajectory modeling was performed to estimate RIC trajectories over 18 months and associated factors in 777 ART-eligible patients. RESULTS Four RIC trajectory groups were identified: (1) group 1 ""remained"" in care (reference, n = 554, 71.3%), (2) group 2 exited care then ""returned"" after [median (interquartile range)] 4 (3-9) months (n = 40, 5.2%), (3) group 3 ""exited care rapidly"" [after 4 (4-6) months, n = 98, 12.6%], and (4) group 4 ""exited care later"" [after 11 (9-13) months, n = 85, 10.9%]. Group 2 patients were less likely to have initiated ART within 1 month and more likely to be male, young (<29 years), without a regular partner, and to have a CD4 count >350 cells/mm. Group 3 patients were more likely to be women without social support, newly diagnosed, young, and less likely to have initiated ART within 1 month. Group 4 patients were more likely to be newly diagnosed and aged 39 years or younger. CONCLUSIONS High CD4 counts at care initiation were not associated with a higher risk of exiting care. Prompt ART initiation and special support for young and newly diagnosed patients with HIV are needed to maximize RIC.",2019,"RESULTS Four RIC trajectory groups were identified: (1) group 1 ""remained"" in care (reference, n = 554, 71.3%), (2) group 2 exited care then ""returned"" after [median (interquartile range)] 4 (3-9) months (n = 40, 5.2%), (3) group 3 ""exited care rapidly"" [after 4 (4-6) months, n = 98, 12.6%], and (4) group 4 ""exited care later"" [after 11 (9-13) months, n = 85, 10.9%].","['Group 2 patients were less likely to have initiated ART within 1 month and more likely to be male, young (<29 years), without a regular partner, and to have a CD4 count >350 cells/mm', 'patients eligible for antiretroviral therapy (ART) in a universal test-and-treat setting (TasP trial, South Africa, 2012-2016', 'HIV-Positive Individuals Participating in a Universal Test-and-Treat Program in Rural South Africa (ANRS 12249', 'young and newly diagnosed patients with HIV', '777 ART-eligible patients', 'Exiting care was defined as ≥3 months late for a clinic appointment, transferring elsewhere, or death', 'Group 4 patients were more likely to be newly diagnosed and aged 39 years or younger', 'individuals identified HIV positive after home-based testing were invited to initiate ART immediately (intervention) or following national guidelines (control']",[],[],"[{'cui': 'C0441865', 'cui_str': 'Group 2 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis (contextual qualifier) (qualifier value)'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205272', 'cui_str': 'Regular (qualifier value)'}, {'cui': 'C0682323', 'cui_str': 'Companion'}, {'cui': 'C0243009', 'cui_str': 'CD4+ Counts'}, {'cui': 'C4517735', 'cui_str': '350'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0175671', 'cui_str': 'Universal (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0037712', 'cui_str': 'Union of South Africa'}, {'cui': 'C0019699', 'cui_str': 'HTLV-III Seroconversion'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0337094', 'cui_str': 'Exit (qualifier value)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0003629', 'cui_str': 'Appointments'}, {'cui': 'C0040671', 'cui_str': 'Transfer'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0441876', 'cui_str': 'Group 4 (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0220845', 'cui_str': 'guidelines'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]",[],[],,0.0974718,"RESULTS Four RIC trajectory groups were identified: (1) group 1 ""remained"" in care (reference, n = 554, 71.3%), (2) group 2 exited care then ""returned"" after [median (interquartile range)] 4 (3-9) months (n = 40, 5.2%), (3) group 3 ""exited care rapidly"" [after 4 (4-6) months, n = 98, 12.6%], and (4) group 4 ""exited care later"" [after 11 (9-13) months, n = 85, 10.9%].","[{'ForeName': 'Andréa', 'Initials': 'A', 'LastName': 'Gosset', 'Affiliation': ""INSERM, IRD, SESSTIM, Sciences Economiques & Sociales de la Santé, Traitement de l'Information Médicale, Aix Marseille University, Marseille, France.""}, {'ForeName': 'Camelia', 'Initials': 'C', 'LastName': 'Protopopescu', 'Affiliation': ""INSERM, IRD, SESSTIM, Sciences Economiques & Sociales de la Santé, Traitement de l'Information Médicale, Aix Marseille University, Marseille, France.""}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Larmarange', 'Affiliation': 'Africa Health Research Institute, KwaZulu-Natal, South Africa.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Orne-Gliemann', 'Affiliation': 'Inserm, UMR 1219, Bordeaux Population Health Research Center, University Bordeaux, Bordeaux, France.'}, {'ForeName': 'Nuala', 'Initials': 'N', 'LastName': 'McGrath', 'Affiliation': 'Faculty of Medicine and Faculty of Human, Social and Mathematical Sciences, University of Southampton, United Kingdom.'}, {'ForeName': 'Deenan', 'Initials': 'D', 'LastName': 'Pillay', 'Affiliation': 'Africa Health Research Institute, KwaZulu-Natal, South Africa.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Dabis', 'Affiliation': 'Inserm, UMR 1219, Bordeaux Population Health Research Center, University Bordeaux, Bordeaux, France.'}, {'ForeName': 'Collins', 'Initials': 'C', 'LastName': 'Iwuji', 'Affiliation': 'Department of Global Health & Infection, Brighton and Sussex Medical School, Brighton, United Kingdom.'}, {'ForeName': 'Sylvie', 'Initials': 'S', 'LastName': 'Boyer', 'Affiliation': ""INSERM, IRD, SESSTIM, Sciences Economiques & Sociales de la Santé, Traitement de l'Information Médicale, Aix Marseille University, Marseille, France.""}]",Journal of acquired immune deficiency syndromes (1999),['10.1097/QAI.0000000000001938'] 733,30415786,Implementing statistical methods for generalizing randomized trial findings to a target population.,"Randomized trials are considered the gold standard for assessing the causal effects of a drug or intervention in a study population, and their results are often utilized in the formulation of health policy. However, there is growing concern that results from trials do not necessarily generalize well to their respective target populations, in which policies are enacted, due to substantial demographic differences between study and target populations. In trials related to substance use disorders (SUDs), especially, strict exclusion criteria make it challenging to obtain study samples that are fully ""representative"" of the populations that policymakers may wish to generalize their results to. In this paper, we provide an overview of post-trial statistical methods for assessing and improving upon the generalizability of a randomized trial to a well-defined target population. We then illustrate the different methods using a randomized trial related to methamphetamine dependence and a target population of substance abuse treatment seekers, and provide software to implement the methods in R using the ""generalize"" package. We discuss several practical considerations for researchers who wish to utilize these tools, such as the importance of acquiring population-level data to represent the target population of interest, and the challenges of data harmonization.",2019,"We then illustrate the different methods using a randomized trial related to methamphetamine dependence and a target population of substance abuse treatment seekers, and provide software to implement the methods in R using the ""generalize"" package.",[],[],[],[],[],[],,0.0726531,"We then illustrate the different methods using a randomized trial related to methamphetamine dependence and a target population of substance abuse treatment seekers, and provide software to implement the methods in R using the ""generalize"" package.","[{'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Ackerman', 'Affiliation': 'Department of Biostatistics, The Johns Hopkins Bloomberg School of Public Health, USA. Electronic address: backer10@jhu.edu.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Schmid', 'Affiliation': 'Department of Mental Health, The Johns Hopkins Bloomberg School of Public Health, USA.'}, {'ForeName': 'Kara E', 'Initials': 'KE', 'LastName': 'Rudolph', 'Affiliation': 'Emergency Medicine, School of Medicine, University of California, Davis, USA.'}, {'ForeName': 'Marissa J', 'Initials': 'MJ', 'LastName': 'Seamans', 'Affiliation': 'Department of Mental Health, The Johns Hopkins Bloomberg School of Public Health, USA.'}, {'ForeName': 'Ryoko', 'Initials': 'R', 'LastName': 'Susukida', 'Affiliation': 'Department of Mental Health Policy, National Center of Neurology and Psychiatry, Japan.'}, {'ForeName': 'Ramin', 'Initials': 'R', 'LastName': 'Mojtabai', 'Affiliation': 'Department of Mental Health, The Johns Hopkins Bloomberg School of Public Health, USA.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Stuart', 'Affiliation': 'Department of Biostatistics, The Johns Hopkins Bloomberg School of Public Health, USA; Department of Mental Health, The Johns Hopkins Bloomberg School of Public Health, USA.'}]",Addictive behaviors,['10.1016/j.addbeh.2018.10.033'] 734,30311850,Mediation analyses of Internet-facilitated cognitive behavioral intervention for maternal depression.,"This study evaluated the putative mediating mechanisms of an Internet-facilitated cognitive-behavioral therapy (CBT) intervention for depression tailored to economically disadvantaged mothers of preschool-age children. The CBT mediators were tested across two previously published randomized controlled trials which included the same measures of behavioral activation, negative thinking, and savoring of positive events. Trial 1 included 70 mothers with elevated depressive symptoms who were randomized to either the eight-session, Internet-facilitated intervention (Mom-Net) or to treatment as usual. Trial 2 included 266 mothers with elevated depressive symptoms who were randomized to either Mom-Net or to a motivational interviewing and referral to services condition. Simple mediation models tested each putative mediator independently followed by tests of multiple mediation that simultaneously included all three mediators in the model to assess the salient contributions of each mediator. The pattern of results for the mediating effects were systematically replicated across the two trials and suggest that behavioral activation and negative thinking are salient mediators of the Mom-Net intervention; significant mediating effects for savoring were obtained only in the simple mediation models and were not obtained in the multiple mediation models.",2019,"Trial 1 included 70 mothers with elevated depressive symptoms who were randomized to either the eight-session, Internet-facilitated intervention (Mom-Net) or to treatment as usual.","['disadvantaged mothers of preschool-age children', '70 mothers with elevated depressive symptoms', '266 mothers with elevated depressive symptoms', 'maternal depression']","['Internet-facilitated cognitive behavioral intervention', 'Internet-facilitated intervention (Mom-Net) or to treatment as usual', 'Internet-facilitated cognitive-behavioral therapy (CBT) intervention', 'Mom-Net or to a motivational interviewing and referral to services condition']","['behavioral activation, negative thinking, and savoring of positive events']","[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C1442163', 'cui_str': 'Multiple of the median'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0683474', 'cui_str': 'Motivational Interviewing'}, {'cui': 'C0584065', 'cui_str': 'Referral to service (procedure)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C0424134', 'cui_str': 'Negative Thinking'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}]",266.0,0.0512391,"Trial 1 included 70 mothers with elevated depressive symptoms who were randomized to either the eight-session, Internet-facilitated intervention (Mom-Net) or to treatment as usual.","[{'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Seeley', 'Affiliation': 'a Oregon Research Institute , Eugene , OR , USA.'}, {'ForeName': 'Lisa B', 'Initials': 'LB', 'LastName': 'Sheeber', 'Affiliation': 'a Oregon Research Institute , Eugene , OR , USA.'}, {'ForeName': 'Edward G', 'Initials': 'EG', 'LastName': 'Feil', 'Affiliation': 'a Oregon Research Institute , Eugene , OR , USA.'}, {'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Leve', 'Affiliation': 'a Oregon Research Institute , Eugene , OR , USA.'}, {'ForeName': 'Betsy', 'Initials': 'B', 'LastName': 'Davis', 'Affiliation': 'a Oregon Research Institute , Eugene , OR , USA.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Sorensen', 'Affiliation': 'b Private Practise , Eugene , OR , USA.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Allan', 'Affiliation': 'c Options Counseling , Eugene , OR , USA.'}]",Cognitive behaviour therapy,['10.1080/16506073.2018.1513554'] 735,30283029,"Double-blind, placebo-controlled, dose-ranging trial of intravenous ketamine as adjunctive therapy in treatment-resistant depression (TRD).","Numerous placebo-controlled studies have demonstrated the ability of ketamine, an NMDA receptor antagonist, to induce rapid (within hours), transient antidepressant effects when administered intravenously (IV) at subanesthetic doses (0.5 mg/kg over 40 min). However, the optimal antidepressant dose remains unknown. We aimed to compare to active placebo the rapid acting antidepressant properties of a broad range of subanesthetic doses of IV ketamine among outpatients with treatment-resistant depression (TRD). A range of IV ketamine doses were compared to active placebo in the treatment of adult TRD over a 3-day period following a single infusion over 40 min. This was an outpatient study conducted across six US academic sites. Outpatients were 18-70 years old with TRD, defined as failure to achieve a satisfactory response (e.g., less than 50% improvement of depression symptoms) to at least two adequate treatment courses during the current depressive episode. Following a washout period, 99 eligible subjects were randomly assigned to one of the five arms in a 1:1:1:1:1 fashion: a single intravenous dose of ketamine 0.1 mg/kg (n = 18), a single dose of ketamine 0.2 mg/kg (n = 20), a single dose of ketamine 0.5 mg/kg (n = 22), a single dose of ketamine 1.0 mg/kg (n = 20), and a single dose of midazolam 0.045 mg/kg (active placebo) (n = 19). The study assessments (HAM-D-6, MADRS, SDQ, PAS, CGI-S, and CGI-I) were performed at days 0, 1, 3 (endpoint), 5, 7, 14, and 30 to assess the safety and efficacy. The overall group × time interaction effect was significant for the primary outcome measure, the HAM-D-6. In post hoc pairwise comparisons controlling for multiple comparisons, standard dose (0.5 mg/kg) and high dose (1 mg/kg) of intravenous ketamine were superior to active placebo; a low dose (0.1 mg/kg) was significant only prior to adjustment (p = 0.02, p-adj = 0.14, d = -0.82 at day 1). Most of the interaction effect was due to differences at day 1, with no significant adjusted pairwise differences at day 3. This pattern generally held for secondary outcomes. The infusions of ketamine were relatively well tolerated compared to active placebo, except for greater dissociative symptoms and transient blood pressure elevations with the higher doses. Our results suggest that there is evidence for the efficacy of the 0.5 mg/kg and 1.0 mg/kg subanesthetic doses of IV ketamine and no clear or consistent evidence for clinically meaningful efficacy of lower doses of IV ketamine. Trial Registration: NCT01920555.",2020,"The infusions of ketamine were relatively well tolerated compared to active placebo, except for greater dissociative symptoms and transient blood pressure elevations with the higher doses.","['99 eligible subjects', 'Outpatients were 18-70 years old with TRD, defined as failure to achieve a satisfactory response (e.g., less than 50% improvement of depression symptoms) to at least two adequate treatment courses during the current depressive episode', 'treatment-resistant depression (TRD', 'outpatients with treatment-resistant depression (TRD']","['ketamine', 'IV ketamine', 'placebo', 'midazolam 0.045\u2009mg/kg (active placebo', 'ketamine 0.1\u2009mg/kg']","['safety and efficacy', 'HAM-D-6', 'dissociative symptoms and transient blood pressure elevations', 'study assessments (HAM-D-6, MADRS, SDQ, PAS, CGI-S, and CGI-I']","[{'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205411', 'cui_str': 'Adequate (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0750729', 'cui_str': 'Courses (qualifier value)'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0349217', 'cui_str': 'Depressive episode'}, {'cui': 'C2063866', 'cui_str': 'Refractory Depression'}]","[{'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0026056', 'cui_str': 'Midazolam'}, {'cui': 'C4517410', 'cui_str': 'Zero point zero four five'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C4517420', 'cui_str': 'Zero point one'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C3853311', 'cui_str': 'Ham'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205374', 'cui_str': 'Transitory (qualifier value)'}, {'cui': 'C0497247', 'cui_str': 'Finding of increased blood pressure (finding)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]",99.0,0.456136,"The infusions of ketamine were relatively well tolerated compared to active placebo, except for greater dissociative symptoms and transient blood pressure elevations with the higher doses.","[{'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Fava', 'Affiliation': 'Massachusetts General Hospital, Boston, MA, USA. mfava@mgh.harvard.edu.'}, {'ForeName': 'Marlene P', 'Initials': 'MP', 'LastName': 'Freeman', 'Affiliation': 'Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Flynn', 'Affiliation': 'Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Judge', 'Affiliation': 'Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Bettina B', 'Initials': 'BB', 'LastName': 'Hoeppner', 'Affiliation': 'Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Cusin', 'Affiliation': 'Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Dawn F', 'Initials': 'DF', 'LastName': 'Ionescu', 'Affiliation': 'Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Sanjay J', 'Initials': 'SJ', 'LastName': 'Mathew', 'Affiliation': 'Baylor College of Medicine/Michael E. Debakey VA Medical Center, Houston, TX, USA.'}, {'ForeName': 'Lee C', 'Initials': 'LC', 'LastName': 'Chang', 'Affiliation': 'Baylor College of Medicine/Michael E. Debakey VA Medical Center, Houston, TX, USA.'}, {'ForeName': 'Dan V', 'Initials': 'DV', 'LastName': 'Iosifescu', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Murrough', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Debattista', 'Affiliation': 'Stanford University School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Alan F', 'Initials': 'AF', 'LastName': 'Schatzberg', 'Affiliation': 'Stanford University School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Madhukar H', 'Initials': 'MH', 'LastName': 'Trivedi', 'Affiliation': 'University of Texas Southwestern, Dallas, TX, USA.'}, {'ForeName': 'Manish K', 'Initials': 'MK', 'LastName': 'Jha', 'Affiliation': 'University of Texas Southwestern, Dallas, TX, USA.'}, {'ForeName': 'Gerard', 'Initials': 'G', 'LastName': 'Sanacora', 'Affiliation': 'Yale University, New Haven, CT, USA.'}, {'ForeName': 'Samuel T', 'Initials': 'ST', 'LastName': 'Wilkinson', 'Affiliation': 'Yale University, New Haven, CT, USA.'}, {'ForeName': 'George I', 'Initials': 'GI', 'LastName': 'Papakostas', 'Affiliation': 'Massachusetts General Hospital, Boston, MA, USA.'}]",Molecular psychiatry,['10.1038/s41380-018-0256-5'] 736,30608570,Individual and Social Factors Related to Trajectories of Blackouts among Underage Drinkers in the Emergency Department.,"AIMS Alcohol-related blackouts can result in acute injuries and other negative outcomes. Among underage risky drinkers, we examined longitudinal trajectories of blackout frequency following an emergency department (ED) visit, and identified baseline characteristics associated with blackout trajectory membership. METHODS Participants (ages 14-20; N = 836) attending an ED who screened positive for risky drinking and enrolled in a randomized-controlled trial of brief alcohol interventions were assessed at baseline, 3-, 6-, and 12-months. We used group-based trajectory modeling to determine characteristic trajectories of blackout frequency over 12-months in relation to baseline characteristics: demographics, substance use, delinquency, depression/anxiety symptoms, sexual assault, dating violence, and peer and sibling influences. RESULTS We identified four groups: No/Low blackouts (n = 248; 29.7%), Declining blackouts (n = 92; 11.0%), Moderate blackouts (n = 337; 40.3%) and High blackouts (n = 159; 19.0%); group membership did not differ based on intervention receipt. In adjusted analyses, compared to the No/Low group all other groups had higher odds of having an alcohol-related baseline ED visit. Female sex, alcohol consumption, prescription drug misuse, sexual assault while incapacitated due to substances, and negative peer influences were positively associated with membership in the High group; College/Greek life involvement was also highest. Negative peer influences and being in high school (vs. College/Greek life) also distinguished the Moderate group. CONCLUSION Blackout frequency was largely stable over time and riskier trajectories were marked by risk factors such as negative peer influences and college/Greek life involvement. Findings may inform targeted interventions, particularly for women who were in higher risk trajectories.",2019,"In adjusted analyses, compared to the No/Low group all other groups had higher odds of having an alcohol-related baseline ED visit.","['underage risky drinkers', 'n = 248; 29.7%), Declining blackouts (n = 92; 11.0%), Moderate blackouts (n = 337; 40.3%) and High blackouts (n = 159; 19.0%); group membership did not differ based on intervention receipt', 'Underage Drinkers in the Emergency Department', 'Methods\n\n\nParticipants (ages 14-20; N = 836) attending an ED who screened positive for risky drinking and enrolled']",['Low blackouts'],"['substance use, delinquency, depression/anxiety symptoms, sexual assault, dating violence, and peer and sibling influences']","[{'cui': 'C0039070', 'cui_str': 'Fainting'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0684271', 'cui_str': 'Drinkings'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0039070', 'cui_str': 'Fainting'}]","[{'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C0522174', 'cui_str': 'Delinquent behavior (finding)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0237236', 'cui_str': 'Sexual assault (event)'}, {'cui': 'C4046106', 'cui_str': 'Dating Violence'}, {'cui': 'C0037047', 'cui_str': 'Sibling'}]",836.0,0.036223,"In adjusted analyses, compared to the No/Low group all other groups had higher odds of having an alcohol-related baseline ED visit.","[{'ForeName': 'Erin E', 'Initials': 'EE', 'LastName': 'Bonar', 'Affiliation': 'Addiction Center, University of Michigan Department of Psychiatry, Ann Arbor, MI.'}, {'ForeName': 'Jason E', 'Initials': 'JE', 'LastName': 'Goldstick', 'Affiliation': 'Injury Prevention Center, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Rebecca M', 'Initials': 'RM', 'LastName': 'Cunningham', 'Affiliation': 'Injury Prevention Center, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Anne C', 'Initials': 'AC', 'LastName': 'Fernandez', 'Affiliation': 'Addiction Center, University of Michigan Department of Psychiatry, Ann Arbor, MI.'}, {'ForeName': 'Alan K', 'Initials': 'AK', 'LastName': 'Davis', 'Affiliation': 'Addiction Center, University of Michigan Department of Psychiatry, Ann Arbor, MI.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Ilgen', 'Affiliation': 'Addiction Center, University of Michigan Department of Psychiatry, Ann Arbor, MI.'}, {'ForeName': 'Maureen A', 'Initials': 'MA', 'LastName': 'Walton', 'Affiliation': 'Addiction Center, University of Michigan Department of Psychiatry, Ann Arbor, MI.'}]","Alcohol and alcoholism (Oxford, Oxfordshire)",['10.1093/alcalc/agy087'] 737,30341969,"Novel Implementation of Genotype-Guided Proton Pump Inhibitor Medication Therapy in Children: A Pilot, Randomized, Multisite Pragmatic Trial.","The efficacy of proton pump inhibitor (PPI) medications is highly dependent on plasma concentrations, which varies considerably due to cytochrome P450 (CYP2C19) genetic variation. We conducted a pragmatic, pilot study of CYP2C19 genotype-guided pediatric dosing of PPI medications. Children aged 5-17 years old with gastric-acid-related conditions were randomized to receive either conventional dosing of a PPI or genotype-guided dosing for a total of 12 weeks. Sixty children (30 in each arm) were enrolled and had comparable baseline characteristics. The mean daily omeprazole equivalent dose prescribed to participants across metabolizer phenotype groups was significantly different in the genotype-guided dosing arm (P < 0.001), but not in the conventional dosing arm. Prescribers waited for the genotype result before prescribing the PPI medication for 90% of the participants in the genotype-guided dosing arm. The number of participants who reported an infection was marginally lower in genotype-guided dosing vs. conventional dosing (20% vs. 44%; P = 0.07). Sinonasal symptoms were higher in the conventional dosing arm as compared with genotype-guided dosing arm: (2.6 (2.0, 3.4) vs. 1.8 (1.0, 2.3), P = 0.031). CYP2C19 genotype-guided PPI therapy is feasible in a clinical pediatric setting, well accepted by providers, resulted in differential PPI dosing, and may reduce PPI-associated infections. A future large scale randomized clinical trial of CYP2C19 genotype-guided pediatric dosing of PPI medications in children is warranted.",2019,The number of participants who reported an infection was marginally lower in genotype-guided dosing vs. conventional dosing (20% vs. 44%; P = 0.07).,"['Sixty children (30 in each arm) were enrolled and had comparable baseline characteristics', 'Children', 'Children aged 5-17\xa0years old with gastric-acid-related conditions']","['inhibitor (PPI) medications', 'Genotype-Guided Proton Pump Inhibitor Medication Therapy', 'CYP2C19 genotype-guided PPI therapy', 'conventional dosing of a PPI or genotype-guided dosing', 'omeprazole', 'proton pump', 'CYP2C19 genotype-guided pediatric dosing of PPI medications']",['Sinonasal symptoms'],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0017119', 'cui_str': 'Hydrochloric Acid, Gastric'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C1285573', 'cui_str': 'Genotype determination'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C4521480', 'cui_str': 'Hydrogen/potassium adenosine triphosphatase enzyme system inhibitor (disposition)'}, {'cui': 'C0013216', 'cui_str': 'Pharmacotherapy'}, {'cui': 'C3714749', 'cui_str': ""S-Mephenytoin 4'-Hydroxylase""}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0028978', 'cui_str': 'Omeprazole'}, {'cui': 'C0018440', 'cui_str': 'Proton Pump'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}]",60.0,0.0580863,The number of participants who reported an infection was marginally lower in genotype-guided dosing vs. conventional dosing (20% vs. 44%; P = 0.07).,"[{'ForeName': 'Emily J', 'Initials': 'EJ', 'LastName': 'Cicali', 'Affiliation': 'University of Florida, Gainesville, Florida, USA.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Blake', 'Affiliation': ""Nemours Children's Specialty Care, Jacksonville, Florida, USA.""}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Gong', 'Affiliation': 'University of Florida, Gainesville, Florida, USA.'}, {'ForeName': 'Edward B', 'Initials': 'EB', 'LastName': 'Mougey', 'Affiliation': ""Nemours Children's Specialty Care, Jacksonville, Florida, USA.""}, {'ForeName': 'Hadeel', 'Initials': 'H', 'LastName': 'Al-Atrash', 'Affiliation': ""Nemours Children's Hospital, Orlando, Florida, USA.""}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Chambers', 'Affiliation': ""Nemours Children's Hospital, Orlando, Florida, USA.""}, {'ForeName': 'Jolanda', 'Initials': 'J', 'LastName': 'Denham', 'Affiliation': ""Nemours Children's Hospital, Orlando, Florida, USA.""}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Evans', 'Affiliation': ""Nemours Children's Specialty Care, Jacksonville, Florida, USA.""}, {'ForeName': 'Donald E', 'Initials': 'DE', 'LastName': 'George', 'Affiliation': ""Nemours Children's Specialty Care, Jacksonville, Florida, USA.""}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Gomez', 'Affiliation': ""Nemours Children's Hospital, Orlando, Florida, USA.""}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Palomo', 'Affiliation': ""Nemours Children's Hospital, Orlando, Florida, USA.""}, {'ForeName': 'Salik', 'Initials': 'S', 'LastName': 'Taufiq', 'Affiliation': ""Nemours Children's Specialty Care, Jacksonville, Florida, USA.""}, {'ForeName': 'Julie A', 'Initials': 'JA', 'LastName': 'Johnson', 'Affiliation': 'University of Florida, Gainesville, Florida, USA.'}, {'ForeName': 'John J', 'Initials': 'JJ', 'LastName': 'Lima', 'Affiliation': ""Nemours Children's Specialty Care, Jacksonville, Florida, USA.""}, {'ForeName': 'James P', 'Initials': 'JP', 'LastName': 'Franciosi', 'Affiliation': ""Nemours Children's Hospital, Orlando, Florida, USA.""}]",Clinical and translational science,['10.1111/cts.12589'] 738,30252544,Asthma dissemination around patient-centered treatments in North Carolina (ADAPT-NC): a cluster randomized control trial evaluating dissemination of an evidence-based shared decision-making intervention for asthma management.,"Objective : To compare three dissemination approaches for implementing an asthma shared decision-making (SDM) intervention into primary care practices. Methods : We randomized thirty practices into three study arms: (1) a facilitator-led approach to implementing SDM; (2) a one-hour lunch-and-learn training on SDM; and (3) a control group with no active intervention. Patient perceptions of SDM were assessed in the active intervention arms using a one-question anonymous survey. Logistic regression models compared the frequency of asthma exacerbations (emergency department (ED) visits, hospitalizations, and oral steroid prescriptions) between the three arms. Results : We collected 705 surveys from facilitator-led sites and 523 from lunch-and-learn sites. Patients were more likely to report that they participated equally with the provider in making the treatment decision in the facilitator-led sites (75% vs. 66%, p  = 0.001). Comparisons of outcomes for patients in the facilitator-led ( n  = 1,658) and lunch-and-learn ( n  = 2,613) arms respectively vs. control ( n  = 2,273) showed no significant differences for ED visits (Odds Ratio [OR] [95%CI] = 0.77[0.57-1.04]; 0.83[0.66-1.07]), hospitalizations (OR [95%CI] = 1.30[0.59-2.89]; 1.40 [0.68-3.06]), or oral steroids (OR [95%CI] =0.95[0.79-1.15]; 1.03[0.81-1.06]). Conclusion : Facilitator-led dissemination was associated with a significantly higher proportion of patients sharing equally in decision-making with the provider compared to a traditional lunch-and-learn approach. While there was no significant difference in health outcomes between the three arms, the results were most likely confounded by a concurrent statewide asthma initiative and the pragmatic implementation of the intervention. These results offer support for the use of structured approaches such as facilitator-led dissemination of complex interventions into primary care practices.",2019,"CONCLUSION Facilitator-led dissemination was associated with a significantly higher proportion of patients sharing equally in decision-making with the provider compared to a traditional lunch-and-learn approach.","['We collected 705 surveys from facilitator-led sites and 523 from lunch-and-learn sites', 'Asthma dissemination around patient-centered treatments in North Carolina (ADAPT-NC']",['facilitator-led approach to implementing SDM; (2) a one-hour lunch-and-learn training on SDM; and (3) a control group with no active intervention'],"['health outcomes', 'frequency of asthma exacerbations (emergency department (ED) visits, hospitalizations, and oral steroid prescriptions', 'ED visits']","[{'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0028407', 'cui_str': 'North Carolina'}]","[{'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C0643808', 'cui_str': 'SDM'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C4552032', 'cui_str': 'With lunch'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0038317', 'cui_str': 'Steroids'}, {'cui': 'C0033080', 'cui_str': 'Prescriptions'}]",30.0,0.150132,"CONCLUSION Facilitator-led dissemination was associated with a significantly higher proportion of patients sharing equally in decision-making with the provider compared to a traditional lunch-and-learn approach.","[{'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Ludden', 'Affiliation': 'Department of Family Medicine, Atrium Health, Charlotte, NC, USA.'}, {'ForeName': 'Lindsay', 'Initials': 'L', 'LastName': 'Shade', 'Affiliation': 'Department of Family Medicine, Atrium Health, Charlotte, NC, USA.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Reeves', 'Affiliation': 'Department of Family Medicine, Atrium Health, Charlotte, NC, USA.'}, {'ForeName': 'Madelyn', 'Initials': 'M', 'LastName': 'Welch', 'Affiliation': 'Department of Family Medicine, Atrium Health, Charlotte, NC, USA.'}, {'ForeName': 'Yhenneko J', 'Initials': 'YJ', 'LastName': 'Taylor', 'Affiliation': 'Center for Outcomes Research and Evaluation, Atrium Health, Charlotte, NC, USA.'}, {'ForeName': 'Sveta', 'Initials': 'S', 'LastName': 'Mohanan', 'Affiliation': 'Department of Family Medicine, Atrium Health, Charlotte, NC, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'McWilliams', 'Affiliation': 'Center for Outcomes Research and Evaluation, Atrium Health, Charlotte, NC, USA.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Halladay', 'Affiliation': 'University of North Carolina Department of Family Medicine, Chapel Hill, NC, USA.'}, {'ForeName': 'Katrina', 'Initials': 'K', 'LastName': 'Donahue', 'Affiliation': 'University of North Carolina Department of Family Medicine, Chapel Hill, NC, USA.'}, {'ForeName': 'Tamera', 'Initials': 'T', 'LastName': 'Coyne-Beasley', 'Affiliation': 'University of North Carolina Department of Family Medicine, Chapel Hill, NC, USA.'}, {'ForeName': 'Rowena J', 'Initials': 'RJ', 'LastName': 'Dolor', 'Affiliation': 'Division General Internal Medicine, Department of Medicine, Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Bray', 'Affiliation': 'Vidant Medical Group, Greenville, NC, USA.'}, {'ForeName': 'Hazel', 'Initials': 'H', 'LastName': 'Tapp', 'Affiliation': 'Department of Family Medicine, Atrium Health, Charlotte, NC, USA.'}]",The Journal of asthma : official journal of the Association for the Care of Asthma,['10.1080/02770903.2018.1514630'] 739,30484824,Risk of Appendiceal Neoplasm in Periappendicular Abscess in Patients Treated With Interval Appendectomy vs Follow-up With Magnetic Resonance Imaging: 1-Year Outcomes of the Peri-Appendicitis Acuta Randomized Clinical Trial.,"Importance The step after conservative treatment of periappendicular abscess arouses controversy, ranging from recommendations to abandon interval appendectomy based on low recurrence rates of the precipitating diagnosis to performing routine interval appendectomy owing to novel findings of increased neoplasm risk at interval appendectomy. To our knowledge, there are no randomized clinical trials with sufficient patient numbers comparing these treatments. Objective To compare interval appendectomy and follow-up with magnetic resonance imaging after initial successful nonoperative treatment of periappendicular abscess. Design, Setting, and Participants The Peri-Appendicitis Acuta randomized clinical trial was a multicenter, noninferiority trial conducted in 5 hospitals in Finland. All patients between age 18 and 60 years with periappendicular abscess diagnosed by computed tomography and successful initial nonoperative treatment from January 2013 to April 2016 were included. Data analysis occurred from April 2016 to September 2017. Interventions Patients were randomized either to interval appendectomy or follow-up with magnetic resonance imaging; all patients underwent colonoscopy. Main Outcomes and Measures The primary end point was treatment success, defined as an absence of postoperative morbidity in the appendectomy group and appendicitis recurrence in the follow-up group. Secondary predefined end points included neoplasm incidence, inflammatory bowel disease, length of hospital stay, and days of sick leave. Results A total of 60 patients were included (36 men [60%]; median [interquartile range] age: interval appendectomy group, 49 [18-60] years; follow-up group, 47 [22-61] years). An interim analysis in April 2016 showed a high rate of neoplasm (10 of 60 [17%]), with all neoplasms in patients older than 40 years. The trial was prematurely terminated owing to ethical concerns. Two more neoplasms were diagnosed after study termination, resulting in an overall neoplasm incidence of 20% (12 of 60). On study termination, the overall morbidity rate of interval appendectomy was 10% (3 of 30), and 10 of the patients in the follow-up group (33%) had undergone appendectomy. Conclusions and Relevance The neoplasm rate after periappendicular abscess in this small study population was high, especially in patients older than 40 years. If this considerable rate of neoplasms after periappendicular abscess is validated by future studies, it would argue for routine interval appendectomy in this setting. Trial Registration ClinicalTrials.gov identifier: NCT03013686.",2019,"The neoplasm rate after periappendicular abscess in this small study population was high, especially in patients older than 40 years.","['patients older than 40 years', '5 hospitals in Finland', 'A total of 60 patients were included (36 men [60%]; median [interquartile range] age: interval appendectomy group, 49 [18-60] years; follow-up group, 47 [22-61] years', 'All patients between age 18 and 60 years with periappendicular abscess diagnosed by computed tomography and successful initial nonoperative treatment from January 2013 to April 2016 were included']","['interval appendectomy or follow-up with magnetic resonance imaging; all patients underwent colonoscopy', 'Interval Appendectomy vs Follow-up With Magnetic Resonance Imaging', 'interval appendectomy and follow-up with magnetic resonance imaging']","['postoperative morbidity', 'appendicitis recurrence', 'neoplasm incidence, inflammatory bowel disease, length of hospital stay, and days of sick leave', 'overall neoplasm incidence', 'overall morbidity rate of interval appendectomy']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0016132', 'cui_str': 'Finland'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0399995', 'cui_str': 'Interval appendectomy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0000833', 'cui_str': 'Abscess'}, {'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0399995', 'cui_str': 'Interval appendectomy'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C1552358', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0009378', 'cui_str': 'Endoscopy of colon'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0003615', 'cui_str': 'Appendicitis'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0021390', 'cui_str': 'Inflammatory Bowel Diseases'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0242807', 'cui_str': 'Sick Leave'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0399995', 'cui_str': 'Interval appendectomy'}]",60.0,0.182047,"The neoplasm rate after periappendicular abscess in this small study population was high, especially in patients older than 40 years.","[{'ForeName': 'Jari', 'Initials': 'J', 'LastName': 'Mällinen', 'Affiliation': 'Department of Surgery, Oulu University Hospital, Oulu, Finland.'}, {'ForeName': 'Tero', 'Initials': 'T', 'LastName': 'Rautio', 'Affiliation': 'Department of Surgery, Oulu University Hospital, Oulu, Finland.'}, {'ForeName': 'Juha', 'Initials': 'J', 'LastName': 'Grönroos', 'Affiliation': 'Division of Digestive Surgery and Urology, Turku University Hospital, Turku, Finland.'}, {'ForeName': 'Tuomo', 'Initials': 'T', 'LastName': 'Rantanen', 'Affiliation': 'Department of Surgery, Kuopio University Hospital, Kuopio, Finland.'}, {'ForeName': 'Pia', 'Initials': 'P', 'LastName': 'Nordström', 'Affiliation': 'Division of Surgery, Gastroenterology and Oncology, Tampere University Hospital, Tampere, Finland.'}, {'ForeName': 'Heini', 'Initials': 'H', 'LastName': 'Savolainen', 'Affiliation': 'Department of Surgery, Kuopio University Hospital, Kuopio, Finland.'}, {'ForeName': 'Pasi', 'Initials': 'P', 'LastName': 'Ohtonen', 'Affiliation': 'Division of Operative Care, Oulu University Hospital and Medical Research Center Oulu, University of Oulu, Oulu, Finland.'}, {'ForeName': 'Saija', 'Initials': 'S', 'LastName': 'Hurme', 'Affiliation': 'Department of Biostatistics, University of Turku, Turku, Finland.'}, {'ForeName': 'Paulina', 'Initials': 'P', 'LastName': 'Salminen', 'Affiliation': 'Division of Digestive Surgery and Urology, Turku University Hospital, Turku, Finland.'}]",JAMA surgery,['10.1001/jamasurg.2018.4373'] 740,30737338,Quality of life predicts outcome of deep brain stimulation in early Parkinson disease.,"OBJECTIVE To investigate predictors for improvement of disease-specific quality of life (QOL) after deep brain stimulation (DBS) of the subthalamic nucleus (STN) for Parkinson disease (PD) with early motor complications. METHODS We performed a secondary analysis of data from the previously published EARLYSTIM study, a prospective randomized trial comparing STN-DBS (n = 124) to best medical treatment (n = 127) after 2 years follow-up with disease-specific QOL (39-item Parkinson's Disease Questionnaire summary index [PDQ-39-SI]) as the primary endpoint. Linear regression analyses of the baseline characteristics age, disease duration, duration of motor complications, and disease severity measured at baseline with the Unified Parkinson's Disease Rating Scale (UPDRS) (UPDRS-III ""off"" and ""on"" medications, UPDRS-IV) were conducted to determine predictors of change in PDQ-39-SI. RESULTS PDQ-39-SI at baseline was correlated to the change in PDQ-39-SI after 24 months in both treatment groups ( p < 0.05). The higher the baseline score (worse QOL) the larger the improvement in QOL after 24 months. No correlation was found for any of the other baseline characteristics analyzed in either treatment group. CONCLUSION Impaired QOL as subjectively evaluated by the patient is the most important predictor of benefit in patients with PD and early motor complications, fulfilling objective gold standard inclusion criteria for STN-DBS. Our results prompt systematically including evaluation of disease-specific QOL when selecting patients with PD for STN-DBS. CLINICALTRIALSGOV IDENTIFIER NCT00354133.",2019,The higher the baseline score (worse QOL),"[""n = 124) to best medical treatment (n = 127) after 2 years follow-up with disease-specific QOL (39-item Parkinson's Disease Questionnaire summary index [PDQ-39-SI"", 'early Parkinson disease', 'Parkinson disease (PD) with early motor complications']","['deep brain stimulation', 'STN-DBS', 'deep brain stimulation (DBS) of the subthalamic nucleus (STN']","['QOL', 'disease duration, duration of motor complications, and disease severity', 'change in PDQ-39-SI', 'baseline score (worse QOL', 'disease-specific quality of life (QOL', 'Unified Parkinson\'s Disease Rating Scale (UPDRS) (UPDRS-III ""off"" and ""on"" medications, UPDRS-IV']","[{'cui': 'C4517553', 'cui_str': '124 (qualifier value)'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0030567', 'cui_str': 'Idiopathic Parkinson Disease'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}]","[{'cui': 'C0394162', 'cui_str': 'Deep Brain Stimulation'}, {'cui': 'C0152355', 'cui_str': 'Nucleus Subthalamicus'}]","[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0034380'}, {'cui': 'C0030567', 'cui_str': 'Idiopathic Parkinson Disease'}, {'cui': 'C0222045'}, {'cui': 'C0439070', 'cui_str': 'III'}]",,0.0419773,The higher the baseline score (worse QOL),"[{'ForeName': 'W M Michael', 'Initials': 'WMM', 'LastName': 'Schuepbach', 'Affiliation': ""From the Département de Neurologie (W.M.M.S., A.H., T.D.H., F.P., Y.A., M.V.), Hôpital Pitié-Salpêtrière, Centre d'Investigation Clinique 1422, Institut du Cerveau et de la Moelle Epinière, Institut National de Santé et en Recherche Médicale, Assistance Publique Hôpitaux de Paris, France; Institute of Neurology (W.M.M.S.), Konolfingen; Department of Neurology (W.M.M.S.), University Hospital Bern and University of Bern, Switzerland; Medtronic (L.T.), Minneapolis, MN; Institute of Clinical Neuroscience & Medical Psychology and Department of Neurology (A.D., L.W.), Medical Faculty, Heinrich-Heine-University Düsseldorf, Germany; Movement Disorder Unit, Neurology (P.K.), CHU Grenoble Alpes; Grenoble Institut des Neurosciences (P.K., V.F., A. Kistner), University Grenoble Alpes; Inserm U1216 (P.K., V.F., A. Kistner), Grenoble, France; Department of Clinical Neurosciences (Neurology) (P.K.), Faculty of Medicine, University of Geneva, Switzerland; Coordinating Center for clinical trials of the Philipps University of Marburg (J.R., C.S.-B.); Neurochirurgische Klinik im Neurozentrum (A.F., L.P., S.P., J. Volkmann, K.K., G.D.),Christian-Albrechts-Universität Kiel; Neurologische Klinik und Poliklinik (J. Volkmann), Universitätsklinikum Würzburg; Department of Neurology (H.S.D., M.T.B., G.R.F., L.T.), University Hospital Cologne; Research Centre Jülich (G.R.F.); Klinik für Neurologie (T.D.H., A. Kühn, A. Kupsch) and Klinik für Neurochirurgie (G.-H.S.), Campus Virchow, Charité-Universitätsmedizin Berlin; Praxis Kupsch (A. Kupsch), Berlin, Germany; Service de Neurochirurgie (E.S.) and Service de Neurologie (V.F.), Hôpital Michallon, Centre Hospitalo-Universitaire, Grenoble; Departments of Neurosurgery (P.P.C.), Neurology (F.O.-M., C.B.-C.), and Clinical Pharmacology (C.B.-C.), University Hospital of Toulouse; ToNIC (F.O.-M., C.B.-C.), Toulouse Neuroimaging Center, University of Toulouse, Inserm, UPS, France; Department of Neurosurgery (J. Vesper), Universitätsklinikum Düsseldorf, Germany; Departments of Neurosurgery (S.D.) and Neurology (D.M.), Rouen University Hospital and University of Rouen; INSERM U1239 (D.M.), Laboratory of Neuronal and Neuroendocrine Differentiation and Communication, Mont-Saint-Aignan; Service de Neurologie (P. Damier, P. Derkinderen), CHU Nantes, Hôpital Laënnec, France; Paracelsus-Elena-Klinik Kassel (F.S.-D., C.T.); Department of Neurosurgery (C.T.), University Medical Center Göttingen; Division of Functional and Restorative Neurosurgery and Centre for Integrative Neuroscience (A.G.), Tübingen; Abteilung für Neurologie (T.W.), Reha-Zentrum Bad Gögging, Passauer Wolf; Department for Neurodegenerative Diseases and Hertie Institute for Clinical Brain Research (D.W.), University of Tübingen; Division of Stereotactic and Functional Neurosurgery (M.O.P.), University Medical Center Freiburg, Germany; Departments of Functional and Stereotactic Neurosurgery and Radiosurgery (J.-.M.R.) and Neurology (T.W.), Timone University Hospital, INSERM, Marseille; Institut des Sciences Cognitives Marc Jeannerod (S.T.), CNRS, UMR 5229, Université de Lyon; Centre Expert Parkinson (S.T.), Service de Neurologie C, Hôpital Neurologique Pierre Wertheimer, Hospices Civils de Lyon, Bron; Department of Neurosurgery (P.M.), University Hospital of Neurology and Neurosurgery, Hospices Civils de Lyon, Université de Lyon; Department of Neurology (J.-L.H.), INSERM-1402, Centre Hospitalier Universitaire de Poitiers, University of Poitiers, France; and Universitätsklinikum Giessen und Marburg (L.T.), Marburg Campus, Germany.""}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Tonder', 'Affiliation': ""From the Département de Neurologie (W.M.M.S., A.H., T.D.H., F.P., Y.A., M.V.), Hôpital Pitié-Salpêtrière, Centre d'Investigation Clinique 1422, Institut du Cerveau et de la Moelle Epinière, Institut National de Santé et en Recherche Médicale, Assistance Publique Hôpitaux de Paris, France; Institute of Neurology (W.M.M.S.), Konolfingen; Department of Neurology (W.M.M.S.), University Hospital Bern and University of Bern, Switzerland; Medtronic (L.T.), Minneapolis, MN; Institute of Clinical Neuroscience & Medical Psychology and Department of Neurology (A.D., L.W.), Medical Faculty, Heinrich-Heine-University Düsseldorf, Germany; Movement Disorder Unit, Neurology (P.K.), CHU Grenoble Alpes; Grenoble Institut des Neurosciences (P.K., V.F., A. Kistner), University Grenoble Alpes; Inserm U1216 (P.K., V.F., A. Kistner), Grenoble, France; Department of Clinical Neurosciences (Neurology) (P.K.), Faculty of Medicine, University of Geneva, Switzerland; Coordinating Center for clinical trials of the Philipps University of Marburg (J.R., C.S.-B.); Neurochirurgische Klinik im Neurozentrum (A.F., L.P., S.P., J. Volkmann, K.K., G.D.),Christian-Albrechts-Universität Kiel; Neurologische Klinik und Poliklinik (J. Volkmann), Universitätsklinikum Würzburg; Department of Neurology (H.S.D., M.T.B., G.R.F., L.T.), University Hospital Cologne; Research Centre Jülich (G.R.F.); Klinik für Neurologie (T.D.H., A. Kühn, A. Kupsch) and Klinik für Neurochirurgie (G.-H.S.), Campus Virchow, Charité-Universitätsmedizin Berlin; Praxis Kupsch (A. Kupsch), Berlin, Germany; Service de Neurochirurgie (E.S.) and Service de Neurologie (V.F.), Hôpital Michallon, Centre Hospitalo-Universitaire, Grenoble; Departments of Neurosurgery (P.P.C.), Neurology (F.O.-M., C.B.-C.), and Clinical Pharmacology (C.B.-C.), University Hospital of Toulouse; ToNIC (F.O.-M., C.B.-C.), Toulouse Neuroimaging Center, University of Toulouse, Inserm, UPS, France; Department of Neurosurgery (J. Vesper), Universitätsklinikum Düsseldorf, Germany; Departments of Neurosurgery (S.D.) and Neurology (D.M.), Rouen University Hospital and University of Rouen; INSERM U1239 (D.M.), Laboratory of Neuronal and Neuroendocrine Differentiation and Communication, Mont-Saint-Aignan; Service de Neurologie (P. Damier, P. Derkinderen), CHU Nantes, Hôpital Laënnec, France; Paracelsus-Elena-Klinik Kassel (F.S.-D., C.T.); Department of Neurosurgery (C.T.), University Medical Center Göttingen; Division of Functional and Restorative Neurosurgery and Centre for Integrative Neuroscience (A.G.), Tübingen; Abteilung für Neurologie (T.W.), Reha-Zentrum Bad Gögging, Passauer Wolf; Department for Neurodegenerative Diseases and Hertie Institute for Clinical Brain Research (D.W.), University of Tübingen; Division of Stereotactic and Functional Neurosurgery (M.O.P.), University Medical Center Freiburg, Germany; Departments of Functional and Stereotactic Neurosurgery and Radiosurgery (J.-.M.R.) and Neurology (T.W.), Timone University Hospital, INSERM, Marseille; Institut des Sciences Cognitives Marc Jeannerod (S.T.), CNRS, UMR 5229, Université de Lyon; Centre Expert Parkinson (S.T.), Service de Neurologie C, Hôpital Neurologique Pierre Wertheimer, Hospices Civils de Lyon, Bron; Department of Neurosurgery (P.M.), University Hospital of Neurology and Neurosurgery, Hospices Civils de Lyon, Université de Lyon; Department of Neurology (J.-L.H.), INSERM-1402, Centre Hospitalier Universitaire de Poitiers, University of Poitiers, France; and Universitätsklinikum Giessen und Marburg (L.T.), Marburg Campus, Germany.""}, {'ForeName': 'Alfons', 'Initials': 'A', 'LastName': 'Schnitzler', 'Affiliation': ""From the Département de Neurologie (W.M.M.S., A.H., T.D.H., F.P., Y.A., M.V.), Hôpital Pitié-Salpêtrière, Centre d'Investigation Clinique 1422, Institut du Cerveau et de la Moelle Epinière, Institut National de Santé et en Recherche Médicale, Assistance Publique Hôpitaux de Paris, France; Institute of Neurology (W.M.M.S.), Konolfingen; Department of Neurology (W.M.M.S.), University Hospital Bern and University of Bern, Switzerland; Medtronic (L.T.), Minneapolis, MN; Institute of Clinical Neuroscience & Medical Psychology and Department of Neurology (A.D., L.W.), Medical Faculty, Heinrich-Heine-University Düsseldorf, Germany; Movement Disorder Unit, Neurology (P.K.), CHU Grenoble Alpes; Grenoble Institut des Neurosciences (P.K., V.F., A. Kistner), University Grenoble Alpes; Inserm U1216 (P.K., V.F., A. Kistner), Grenoble, France; Department of Clinical Neurosciences (Neurology) (P.K.), Faculty of Medicine, University of Geneva, Switzerland; Coordinating Center for clinical trials of the Philipps University of Marburg (J.R., C.S.-B.); Neurochirurgische Klinik im Neurozentrum (A.F., L.P., S.P., J. Volkmann, K.K., G.D.),Christian-Albrechts-Universität Kiel; Neurologische Klinik und Poliklinik (J. Volkmann), Universitätsklinikum Würzburg; Department of Neurology (H.S.D., M.T.B., G.R.F., L.T.), University Hospital Cologne; Research Centre Jülich (G.R.F.); Klinik für Neurologie (T.D.H., A. Kühn, A. Kupsch) and Klinik für Neurochirurgie (G.-H.S.), Campus Virchow, Charité-Universitätsmedizin Berlin; Praxis Kupsch (A. Kupsch), Berlin, Germany; Service de Neurochirurgie (E.S.) and Service de Neurologie (V.F.), Hôpital Michallon, Centre Hospitalo-Universitaire, Grenoble; Departments of Neurosurgery (P.P.C.), Neurology (F.O.-M., C.B.-C.), and Clinical Pharmacology (C.B.-C.), University Hospital of Toulouse; ToNIC (F.O.-M., C.B.-C.), Toulouse Neuroimaging Center, University of Toulouse, Inserm, UPS, France; Department of Neurosurgery (J. Vesper), Universitätsklinikum Düsseldorf, Germany; Departments of Neurosurgery (S.D.) and Neurology (D.M.), Rouen University Hospital and University of Rouen; INSERM U1239 (D.M.), Laboratory of Neuronal and Neuroendocrine Differentiation and Communication, Mont-Saint-Aignan; Service de Neurologie (P. Damier, P. Derkinderen), CHU Nantes, Hôpital Laënnec, France; Paracelsus-Elena-Klinik Kassel (F.S.-D., C.T.); Department of Neurosurgery (C.T.), University Medical Center Göttingen; Division of Functional and Restorative Neurosurgery and Centre for Integrative Neuroscience (A.G.), Tübingen; Abteilung für Neurologie (T.W.), Reha-Zentrum Bad Gögging, Passauer Wolf; Department for Neurodegenerative Diseases and Hertie Institute for Clinical Brain Research (D.W.), University of Tübingen; Division of Stereotactic and Functional Neurosurgery (M.O.P.), University Medical Center Freiburg, Germany; Departments of Functional and Stereotactic Neurosurgery and Radiosurgery (J.-.M.R.) and Neurology (T.W.), Timone University Hospital, INSERM, Marseille; Institut des Sciences Cognitives Marc Jeannerod (S.T.), CNRS, UMR 5229, Université de Lyon; Centre Expert Parkinson (S.T.), Service de Neurologie C, Hôpital Neurologique Pierre Wertheimer, Hospices Civils de Lyon, Bron; Department of Neurosurgery (P.M.), University Hospital of Neurology and Neurosurgery, Hospices Civils de Lyon, Université de Lyon; Department of Neurology (J.-L.H.), INSERM-1402, Centre Hospitalier Universitaire de Poitiers, University of Poitiers, France; and Universitätsklinikum Giessen und Marburg (L.T.), Marburg Campus, Germany.""}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Krack', 'Affiliation': ""From the Département de Neurologie (W.M.M.S., A.H., T.D.H., F.P., Y.A., M.V.), Hôpital Pitié-Salpêtrière, Centre d'Investigation Clinique 1422, Institut du Cerveau et de la Moelle Epinière, Institut National de Santé et en Recherche Médicale, Assistance Publique Hôpitaux de Paris, France; Institute of Neurology (W.M.M.S.), Konolfingen; Department of Neurology (W.M.M.S.), University Hospital Bern and University of Bern, Switzerland; Medtronic (L.T.), Minneapolis, MN; Institute of Clinical Neuroscience & Medical Psychology and Department of Neurology (A.D., L.W.), Medical Faculty, Heinrich-Heine-University Düsseldorf, Germany; Movement Disorder Unit, Neurology (P.K.), CHU Grenoble Alpes; Grenoble Institut des Neurosciences (P.K., V.F., A. Kistner), University Grenoble Alpes; Inserm U1216 (P.K., V.F., A. Kistner), Grenoble, France; Department of Clinical Neurosciences (Neurology) (P.K.), Faculty of Medicine, University of Geneva, Switzerland; Coordinating Center for clinical trials of the Philipps University of Marburg (J.R., C.S.-B.); Neurochirurgische Klinik im Neurozentrum (A.F., L.P., S.P., J. Volkmann, K.K., G.D.),Christian-Albrechts-Universität Kiel; Neurologische Klinik und Poliklinik (J. Volkmann), Universitätsklinikum Würzburg; Department of Neurology (H.S.D., M.T.B., G.R.F., L.T.), University Hospital Cologne; Research Centre Jülich (G.R.F.); Klinik für Neurologie (T.D.H., A. Kühn, A. Kupsch) and Klinik für Neurochirurgie (G.-H.S.), Campus Virchow, Charité-Universitätsmedizin Berlin; Praxis Kupsch (A. Kupsch), Berlin, Germany; Service de Neurochirurgie (E.S.) and Service de Neurologie (V.F.), Hôpital Michallon, Centre Hospitalo-Universitaire, Grenoble; Departments of Neurosurgery (P.P.C.), Neurology (F.O.-M., C.B.-C.), and Clinical Pharmacology (C.B.-C.), University Hospital of Toulouse; ToNIC (F.O.-M., C.B.-C.), Toulouse Neuroimaging Center, University of Toulouse, Inserm, UPS, France; Department of Neurosurgery (J. Vesper), Universitätsklinikum Düsseldorf, Germany; Departments of Neurosurgery (S.D.) and Neurology (D.M.), Rouen University Hospital and University of Rouen; INSERM U1239 (D.M.), Laboratory of Neuronal and Neuroendocrine Differentiation and Communication, Mont-Saint-Aignan; Service de Neurologie (P. Damier, P. Derkinderen), CHU Nantes, Hôpital Laënnec, France; Paracelsus-Elena-Klinik Kassel (F.S.-D., C.T.); Department of Neurosurgery (C.T.), University Medical Center Göttingen; Division of Functional and Restorative Neurosurgery and Centre for Integrative Neuroscience (A.G.), Tübingen; Abteilung für Neurologie (T.W.), Reha-Zentrum Bad Gögging, Passauer Wolf; Department for Neurodegenerative Diseases and Hertie Institute for Clinical Brain Research (D.W.), University of Tübingen; Division of Stereotactic and Functional Neurosurgery (M.O.P.), University Medical Center Freiburg, Germany; Departments of Functional and Stereotactic Neurosurgery and Radiosurgery (J.-.M.R.) and Neurology (T.W.), Timone University Hospital, INSERM, Marseille; Institut des Sciences Cognitives Marc Jeannerod (S.T.), CNRS, UMR 5229, Université de Lyon; Centre Expert Parkinson (S.T.), Service de Neurologie C, Hôpital Neurologique Pierre Wertheimer, Hospices Civils de Lyon, Bron; Department of Neurosurgery (P.M.), University Hospital of Neurology and Neurosurgery, Hospices Civils de Lyon, Université de Lyon; Department of Neurology (J.-L.H.), INSERM-1402, Centre Hospitalier Universitaire de Poitiers, University of Poitiers, France; and Universitätsklinikum Giessen und Marburg (L.T.), Marburg Campus, Germany.""}, {'ForeName': 'Joern', 'Initials': 'J', 'LastName': 'Rau', 'Affiliation': ""From the Département de Neurologie (W.M.M.S., A.H., T.D.H., F.P., Y.A., M.V.), Hôpital Pitié-Salpêtrière, Centre d'Investigation Clinique 1422, Institut du Cerveau et de la Moelle Epinière, Institut National de Santé et en Recherche Médicale, Assistance Publique Hôpitaux de Paris, France; Institute of Neurology (W.M.M.S.), Konolfingen; Department of Neurology (W.M.M.S.), University Hospital Bern and University of Bern, Switzerland; Medtronic (L.T.), Minneapolis, MN; Institute of Clinical Neuroscience & Medical Psychology and Department of Neurology (A.D., L.W.), Medical Faculty, Heinrich-Heine-University Düsseldorf, Germany; Movement Disorder Unit, Neurology (P.K.), CHU Grenoble Alpes; Grenoble Institut des Neurosciences (P.K., V.F., A. Kistner), University Grenoble Alpes; Inserm U1216 (P.K., V.F., A. Kistner), Grenoble, France; Department of Clinical Neurosciences (Neurology) (P.K.), Faculty of Medicine, University of Geneva, Switzerland; Coordinating Center for clinical trials of the Philipps University of Marburg (J.R., C.S.-B.); Neurochirurgische Klinik im Neurozentrum (A.F., L.P., S.P., J. Volkmann, K.K., G.D.),Christian-Albrechts-Universität Kiel; Neurologische Klinik und Poliklinik (J. Volkmann), Universitätsklinikum Würzburg; Department of Neurology (H.S.D., M.T.B., G.R.F., L.T.), University Hospital Cologne; Research Centre Jülich (G.R.F.); Klinik für Neurologie (T.D.H., A. Kühn, A. Kupsch) and Klinik für Neurochirurgie (G.-H.S.), Campus Virchow, Charité-Universitätsmedizin Berlin; Praxis Kupsch (A. Kupsch), Berlin, Germany; Service de Neurochirurgie (E.S.) and Service de Neurologie (V.F.), Hôpital Michallon, Centre Hospitalo-Universitaire, Grenoble; Departments of Neurosurgery (P.P.C.), Neurology (F.O.-M., C.B.-C.), and Clinical Pharmacology (C.B.-C.), University Hospital of Toulouse; ToNIC (F.O.-M., C.B.-C.), Toulouse Neuroimaging Center, University of Toulouse, Inserm, UPS, France; Department of Neurosurgery (J. Vesper), Universitätsklinikum Düsseldorf, Germany; Departments of Neurosurgery (S.D.) and Neurology (D.M.), Rouen University Hospital and University of Rouen; INSERM U1239 (D.M.), Laboratory of Neuronal and Neuroendocrine Differentiation and Communication, Mont-Saint-Aignan; Service de Neurologie (P. Damier, P. Derkinderen), CHU Nantes, Hôpital Laënnec, France; Paracelsus-Elena-Klinik Kassel (F.S.-D., C.T.); Department of Neurosurgery (C.T.), University Medical Center Göttingen; Division of Functional and Restorative Neurosurgery and Centre for Integrative Neuroscience (A.G.), Tübingen; Abteilung für Neurologie (T.W.), Reha-Zentrum Bad Gögging, Passauer Wolf; Department for Neurodegenerative Diseases and Hertie Institute for Clinical Brain Research (D.W.), University of Tübingen; Division of Stereotactic and Functional Neurosurgery (M.O.P.), University Medical Center Freiburg, Germany; Departments of Functional and Stereotactic Neurosurgery and Radiosurgery (J.-.M.R.) and Neurology (T.W.), Timone University Hospital, INSERM, Marseille; Institut des Sciences Cognitives Marc Jeannerod (S.T.), CNRS, UMR 5229, Université de Lyon; Centre Expert Parkinson (S.T.), Service de Neurologie C, Hôpital Neurologique Pierre Wertheimer, Hospices Civils de Lyon, Bron; Department of Neurosurgery (P.M.), University Hospital of Neurology and Neurosurgery, Hospices Civils de Lyon, Université de Lyon; Department of Neurology (J.-L.H.), INSERM-1402, Centre Hospitalier Universitaire de Poitiers, University of Poitiers, France; and Universitätsklinikum Giessen und Marburg (L.T.), Marburg Campus, Germany.""}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Hartmann', 'Affiliation': ""From the Département de Neurologie (W.M.M.S., A.H., T.D.H., F.P., Y.A., M.V.), Hôpital Pitié-Salpêtrière, Centre d'Investigation Clinique 1422, Institut du Cerveau et de la Moelle Epinière, Institut National de Santé et en Recherche Médicale, Assistance Publique Hôpitaux de Paris, France; Institute of Neurology (W.M.M.S.), Konolfingen; Department of Neurology (W.M.M.S.), University Hospital Bern and University of Bern, Switzerland; Medtronic (L.T.), Minneapolis, MN; Institute of Clinical Neuroscience & Medical Psychology and Department of Neurology (A.D., L.W.), Medical Faculty, Heinrich-Heine-University Düsseldorf, Germany; Movement Disorder Unit, Neurology (P.K.), CHU Grenoble Alpes; Grenoble Institut des Neurosciences (P.K., V.F., A. Kistner), University Grenoble Alpes; Inserm U1216 (P.K., V.F., A. Kistner), Grenoble, France; Department of Clinical Neurosciences (Neurology) (P.K.), Faculty of Medicine, University of Geneva, Switzerland; Coordinating Center for clinical trials of the Philipps University of Marburg (J.R., C.S.-B.); Neurochirurgische Klinik im Neurozentrum (A.F., L.P., S.P., J. Volkmann, K.K., G.D.),Christian-Albrechts-Universität Kiel; Neurologische Klinik und Poliklinik (J. Volkmann), Universitätsklinikum Würzburg; Department of Neurology (H.S.D., M.T.B., G.R.F., L.T.), University Hospital Cologne; Research Centre Jülich (G.R.F.); Klinik für Neurologie (T.D.H., A. Kühn, A. Kupsch) and Klinik für Neurochirurgie (G.-H.S.), Campus Virchow, Charité-Universitätsmedizin Berlin; Praxis Kupsch (A. Kupsch), Berlin, Germany; Service de Neurochirurgie (E.S.) and Service de Neurologie (V.F.), Hôpital Michallon, Centre Hospitalo-Universitaire, Grenoble; Departments of Neurosurgery (P.P.C.), Neurology (F.O.-M., C.B.-C.), and Clinical Pharmacology (C.B.-C.), University Hospital of Toulouse; ToNIC (F.O.-M., C.B.-C.), Toulouse Neuroimaging Center, University of Toulouse, Inserm, UPS, France; Department of Neurosurgery (J. Vesper), Universitätsklinikum Düsseldorf, Germany; Departments of Neurosurgery (S.D.) and Neurology (D.M.), Rouen University Hospital and University of Rouen; INSERM U1239 (D.M.), Laboratory of Neuronal and Neuroendocrine Differentiation and Communication, Mont-Saint-Aignan; Service de Neurologie (P. Damier, P. Derkinderen), CHU Nantes, Hôpital Laënnec, France; Paracelsus-Elena-Klinik Kassel (F.S.-D., C.T.); Department of Neurosurgery (C.T.), University Medical Center Göttingen; Division of Functional and Restorative Neurosurgery and Centre for Integrative Neuroscience (A.G.), Tübingen; Abteilung für Neurologie (T.W.), Reha-Zentrum Bad Gögging, Passauer Wolf; Department for Neurodegenerative Diseases and Hertie Institute for Clinical Brain Research (D.W.), University of Tübingen; Division of Stereotactic and Functional Neurosurgery (M.O.P.), University Medical Center Freiburg, Germany; Departments of Functional and Stereotactic Neurosurgery and Radiosurgery (J.-.M.R.) and Neurology (T.W.), Timone University Hospital, INSERM, Marseille; Institut des Sciences Cognitives Marc Jeannerod (S.T.), CNRS, UMR 5229, Université de Lyon; Centre Expert Parkinson (S.T.), Service de Neurologie C, Hôpital Neurologique Pierre Wertheimer, Hospices Civils de Lyon, Bron; Department of Neurosurgery (P.M.), University Hospital of Neurology and Neurosurgery, Hospices Civils de Lyon, Université de Lyon; Department of Neurology (J.-L.H.), INSERM-1402, Centre Hospitalier Universitaire de Poitiers, University of Poitiers, France; and Universitätsklinikum Giessen und Marburg (L.T.), Marburg Campus, Germany.""}, {'ForeName': 'Thomas D', 'Initials': 'TD', 'LastName': 'Hälbig', 'Affiliation': ""From the Département de Neurologie (W.M.M.S., A.H., T.D.H., F.P., Y.A., M.V.), Hôpital Pitié-Salpêtrière, Centre d'Investigation Clinique 1422, Institut du Cerveau et de la Moelle Epinière, Institut National de Santé et en Recherche Médicale, Assistance Publique Hôpitaux de Paris, France; Institute of Neurology (W.M.M.S.), Konolfingen; Department of Neurology (W.M.M.S.), University Hospital Bern and University of Bern, Switzerland; Medtronic (L.T.), Minneapolis, MN; Institute of Clinical Neuroscience & Medical Psychology and Department of Neurology (A.D., L.W.), Medical Faculty, Heinrich-Heine-University Düsseldorf, Germany; Movement Disorder Unit, Neurology (P.K.), CHU Grenoble Alpes; Grenoble Institut des Neurosciences (P.K., V.F., A. Kistner), University Grenoble Alpes; Inserm U1216 (P.K., V.F., A. Kistner), Grenoble, France; Department of Clinical Neurosciences (Neurology) (P.K.), Faculty of Medicine, University of Geneva, Switzerland; Coordinating Center for clinical trials of the Philipps University of Marburg (J.R., C.S.-B.); Neurochirurgische Klinik im Neurozentrum (A.F., L.P., S.P., J. Volkmann, K.K., G.D.),Christian-Albrechts-Universität Kiel; Neurologische Klinik und Poliklinik (J. Volkmann), Universitätsklinikum Würzburg; Department of Neurology (H.S.D., M.T.B., G.R.F., L.T.), University Hospital Cologne; Research Centre Jülich (G.R.F.); Klinik für Neurologie (T.D.H., A. Kühn, A. Kupsch) and Klinik für Neurochirurgie (G.-H.S.), Campus Virchow, Charité-Universitätsmedizin Berlin; Praxis Kupsch (A. Kupsch), Berlin, Germany; Service de Neurochirurgie (E.S.) and Service de Neurologie (V.F.), Hôpital Michallon, Centre Hospitalo-Universitaire, Grenoble; Departments of Neurosurgery (P.P.C.), Neurology (F.O.-M., C.B.-C.), and Clinical Pharmacology (C.B.-C.), University Hospital of Toulouse; ToNIC (F.O.-M., C.B.-C.), Toulouse Neuroimaging Center, University of Toulouse, Inserm, UPS, France; Department of Neurosurgery (J. Vesper), Universitätsklinikum Düsseldorf, Germany; Departments of Neurosurgery (S.D.) and Neurology (D.M.), Rouen University Hospital and University of Rouen; INSERM U1239 (D.M.), Laboratory of Neuronal and Neuroendocrine Differentiation and Communication, Mont-Saint-Aignan; Service de Neurologie (P. Damier, P. Derkinderen), CHU Nantes, Hôpital Laënnec, France; Paracelsus-Elena-Klinik Kassel (F.S.-D., C.T.); Department of Neurosurgery (C.T.), University Medical Center Göttingen; Division of Functional and Restorative Neurosurgery and Centre for Integrative Neuroscience (A.G.), Tübingen; Abteilung für Neurologie (T.W.), Reha-Zentrum Bad Gögging, Passauer Wolf; Department for Neurodegenerative Diseases and Hertie Institute for Clinical Brain Research (D.W.), University of Tübingen; Division of Stereotactic and Functional Neurosurgery (M.O.P.), University Medical Center Freiburg, Germany; Departments of Functional and Stereotactic Neurosurgery and Radiosurgery (J.-.M.R.) and Neurology (T.W.), Timone University Hospital, INSERM, Marseille; Institut des Sciences Cognitives Marc Jeannerod (S.T.), CNRS, UMR 5229, Université de Lyon; Centre Expert Parkinson (S.T.), Service de Neurologie C, Hôpital Neurologique Pierre Wertheimer, Hospices Civils de Lyon, Bron; Department of Neurosurgery (P.M.), University Hospital of Neurology and Neurosurgery, Hospices Civils de Lyon, Université de Lyon; Department of Neurology (J.-L.H.), INSERM-1402, Centre Hospitalier Universitaire de Poitiers, University of Poitiers, France; and Universitätsklinikum Giessen und Marburg (L.T.), Marburg Campus, Germany.""}, {'ForeName': 'Fanny', 'Initials': 'F', 'LastName': 'Pineau', 'Affiliation': ""From the Département de Neurologie (W.M.M.S., A.H., T.D.H., F.P., Y.A., M.V.), Hôpital Pitié-Salpêtrière, Centre d'Investigation Clinique 1422, Institut du Cerveau et de la Moelle Epinière, Institut National de Santé et en Recherche Médicale, Assistance Publique Hôpitaux de Paris, France; Institute of Neurology (W.M.M.S.), Konolfingen; Department of Neurology (W.M.M.S.), University Hospital Bern and University of Bern, Switzerland; Medtronic (L.T.), Minneapolis, MN; Institute of Clinical Neuroscience & Medical Psychology and Department of Neurology (A.D., L.W.), Medical Faculty, Heinrich-Heine-University Düsseldorf, Germany; Movement Disorder Unit, Neurology (P.K.), CHU Grenoble Alpes; Grenoble Institut des Neurosciences (P.K., V.F., A. Kistner), University Grenoble Alpes; Inserm U1216 (P.K., V.F., A. Kistner), Grenoble, France; Department of Clinical Neurosciences (Neurology) (P.K.), Faculty of Medicine, University of Geneva, Switzerland; Coordinating Center for clinical trials of the Philipps University of Marburg (J.R., C.S.-B.); Neurochirurgische Klinik im Neurozentrum (A.F., L.P., S.P., J. Volkmann, K.K., G.D.),Christian-Albrechts-Universität Kiel; Neurologische Klinik und Poliklinik (J. Volkmann), Universitätsklinikum Würzburg; Department of Neurology (H.S.D., M.T.B., G.R.F., L.T.), University Hospital Cologne; Research Centre Jülich (G.R.F.); Klinik für Neurologie (T.D.H., A. Kühn, A. Kupsch) and Klinik für Neurochirurgie (G.-H.S.), Campus Virchow, Charité-Universitätsmedizin Berlin; Praxis Kupsch (A. Kupsch), Berlin, Germany; Service de Neurochirurgie (E.S.) and Service de Neurologie (V.F.), Hôpital Michallon, Centre Hospitalo-Universitaire, Grenoble; Departments of Neurosurgery (P.P.C.), Neurology (F.O.-M., C.B.-C.), and Clinical Pharmacology (C.B.-C.), University Hospital of Toulouse; ToNIC (F.O.-M., C.B.-C.), Toulouse Neuroimaging Center, University of Toulouse, Inserm, UPS, France; Department of Neurosurgery (J. Vesper), Universitätsklinikum Düsseldorf, Germany; Departments of Neurosurgery (S.D.) and Neurology (D.M.), Rouen University Hospital and University of Rouen; INSERM U1239 (D.M.), Laboratory of Neuronal and Neuroendocrine Differentiation and Communication, Mont-Saint-Aignan; Service de Neurologie (P. Damier, P. Derkinderen), CHU Nantes, Hôpital Laënnec, France; Paracelsus-Elena-Klinik Kassel (F.S.-D., C.T.); Department of Neurosurgery (C.T.), University Medical Center Göttingen; Division of Functional and Restorative Neurosurgery and Centre for Integrative Neuroscience (A.G.), Tübingen; Abteilung für Neurologie (T.W.), Reha-Zentrum Bad Gögging, Passauer Wolf; Department for Neurodegenerative Diseases and Hertie Institute for Clinical Brain Research (D.W.), University of Tübingen; Division of Stereotactic and Functional Neurosurgery (M.O.P.), University Medical Center Freiburg, Germany; Departments of Functional and Stereotactic Neurosurgery and Radiosurgery (J.-.M.R.) and Neurology (T.W.), Timone University Hospital, INSERM, Marseille; Institut des Sciences Cognitives Marc Jeannerod (S.T.), CNRS, UMR 5229, Université de Lyon; Centre Expert Parkinson (S.T.), Service de Neurologie C, Hôpital Neurologique Pierre Wertheimer, Hospices Civils de Lyon, Bron; Department of Neurosurgery (P.M.), University Hospital of Neurology and Neurosurgery, Hospices Civils de Lyon, Université de Lyon; Department of Neurology (J.-L.H.), INSERM-1402, Centre Hospitalier Universitaire de Poitiers, University of Poitiers, France; and Universitätsklinikum Giessen und Marburg (L.T.), Marburg Campus, Germany.""}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Falk', 'Affiliation': ""From the Département de Neurologie (W.M.M.S., A.H., T.D.H., F.P., Y.A., M.V.), Hôpital Pitié-Salpêtrière, Centre d'Investigation Clinique 1422, Institut du Cerveau et de la Moelle Epinière, Institut National de Santé et en Recherche Médicale, Assistance Publique Hôpitaux de Paris, France; Institute of Neurology (W.M.M.S.), Konolfingen; Department of Neurology (W.M.M.S.), University Hospital Bern and University of Bern, Switzerland; Medtronic (L.T.), Minneapolis, MN; Institute of Clinical Neuroscience & Medical Psychology and Department of Neurology (A.D., L.W.), Medical Faculty, Heinrich-Heine-University Düsseldorf, Germany; Movement Disorder Unit, Neurology (P.K.), CHU Grenoble Alpes; Grenoble Institut des Neurosciences (P.K., V.F., A. Kistner), University Grenoble Alpes; Inserm U1216 (P.K., V.F., A. Kistner), Grenoble, France; Department of Clinical Neurosciences (Neurology) (P.K.), Faculty of Medicine, University of Geneva, Switzerland; Coordinating Center for clinical trials of the Philipps University of Marburg (J.R., C.S.-B.); Neurochirurgische Klinik im Neurozentrum (A.F., L.P., S.P., J. Volkmann, K.K., G.D.),Christian-Albrechts-Universität Kiel; Neurologische Klinik und Poliklinik (J. Volkmann), Universitätsklinikum Würzburg; Department of Neurology (H.S.D., M.T.B., G.R.F., L.T.), University Hospital Cologne; Research Centre Jülich (G.R.F.); Klinik für Neurologie (T.D.H., A. Kühn, A. Kupsch) and Klinik für Neurochirurgie (G.-H.S.), Campus Virchow, Charité-Universitätsmedizin Berlin; Praxis Kupsch (A. Kupsch), Berlin, Germany; Service de Neurochirurgie (E.S.) and Service de Neurologie (V.F.), Hôpital Michallon, Centre Hospitalo-Universitaire, Grenoble; Departments of Neurosurgery (P.P.C.), Neurology (F.O.-M., C.B.-C.), and Clinical Pharmacology (C.B.-C.), University Hospital of Toulouse; ToNIC (F.O.-M., C.B.-C.), Toulouse Neuroimaging Center, University of Toulouse, Inserm, UPS, France; Department of Neurosurgery (J. Vesper), Universitätsklinikum Düsseldorf, Germany; Departments of Neurosurgery (S.D.) and Neurology (D.M.), Rouen University Hospital and University of Rouen; INSERM U1239 (D.M.), Laboratory of Neuronal and Neuroendocrine Differentiation and Communication, Mont-Saint-Aignan; Service de Neurologie (P. Damier, P. Derkinderen), CHU Nantes, Hôpital Laënnec, France; Paracelsus-Elena-Klinik Kassel (F.S.-D., C.T.); Department of Neurosurgery (C.T.), University Medical Center Göttingen; Division of Functional and Restorative Neurosurgery and Centre for Integrative Neuroscience (A.G.), Tübingen; Abteilung für Neurologie (T.W.), Reha-Zentrum Bad Gögging, Passauer Wolf; Department for Neurodegenerative Diseases and Hertie Institute for Clinical Brain Research (D.W.), University of Tübingen; Division of Stereotactic and Functional Neurosurgery (M.O.P.), University Medical Center Freiburg, Germany; Departments of Functional and Stereotactic Neurosurgery and Radiosurgery (J.-.M.R.) and Neurology (T.W.), Timone University Hospital, INSERM, Marseille; Institut des Sciences Cognitives Marc Jeannerod (S.T.), CNRS, UMR 5229, Université de Lyon; Centre Expert Parkinson (S.T.), Service de Neurologie C, Hôpital Neurologique Pierre Wertheimer, Hospices Civils de Lyon, Bron; Department of Neurosurgery (P.M.), University Hospital of Neurology and Neurosurgery, Hospices Civils de Lyon, Université de Lyon; Department of Neurology (J.-L.H.), INSERM-1402, Centre Hospitalier Universitaire de Poitiers, University of Poitiers, France; and Universitätsklinikum Giessen und Marburg (L.T.), Marburg Campus, Germany.""}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Paschen', 'Affiliation': ""From the Département de Neurologie (W.M.M.S., A.H., T.D.H., F.P., Y.A., M.V.), Hôpital Pitié-Salpêtrière, Centre d'Investigation Clinique 1422, Institut du Cerveau et de la Moelle Epinière, Institut National de Santé et en Recherche Médicale, Assistance Publique Hôpitaux de Paris, France; Institute of Neurology (W.M.M.S.), Konolfingen; Department of Neurology (W.M.M.S.), University Hospital Bern and University of Bern, Switzerland; Medtronic (L.T.), Minneapolis, MN; Institute of Clinical Neuroscience & Medical Psychology and Department of Neurology (A.D., L.W.), Medical Faculty, Heinrich-Heine-University Düsseldorf, Germany; Movement Disorder Unit, Neurology (P.K.), CHU Grenoble Alpes; Grenoble Institut des Neurosciences (P.K., V.F., A. Kistner), University Grenoble Alpes; Inserm U1216 (P.K., V.F., A. Kistner), Grenoble, France; Department of Clinical Neurosciences (Neurology) (P.K.), Faculty of Medicine, University of Geneva, Switzerland; Coordinating Center for clinical trials of the Philipps University of Marburg (J.R., C.S.-B.); Neurochirurgische Klinik im Neurozentrum (A.F., L.P., S.P., J. Volkmann, K.K., G.D.),Christian-Albrechts-Universität Kiel; Neurologische Klinik und Poliklinik (J. Volkmann), Universitätsklinikum Würzburg; Department of Neurology (H.S.D., M.T.B., G.R.F., L.T.), University Hospital Cologne; Research Centre Jülich (G.R.F.); Klinik für Neurologie (T.D.H., A. Kühn, A. Kupsch) and Klinik für Neurochirurgie (G.-H.S.), Campus Virchow, Charité-Universitätsmedizin Berlin; Praxis Kupsch (A. Kupsch), Berlin, Germany; Service de Neurochirurgie (E.S.) and Service de Neurologie (V.F.), Hôpital Michallon, Centre Hospitalo-Universitaire, Grenoble; Departments of Neurosurgery (P.P.C.), Neurology (F.O.-M., C.B.-C.), and Clinical Pharmacology (C.B.-C.), University Hospital of Toulouse; ToNIC (F.O.-M., C.B.-C.), Toulouse Neuroimaging Center, University of Toulouse, Inserm, UPS, France; Department of Neurosurgery (J. Vesper), Universitätsklinikum Düsseldorf, Germany; Departments of Neurosurgery (S.D.) and Neurology (D.M.), Rouen University Hospital and University of Rouen; INSERM U1239 (D.M.), Laboratory of Neuronal and Neuroendocrine Differentiation and Communication, Mont-Saint-Aignan; Service de Neurologie (P. Damier, P. Derkinderen), CHU Nantes, Hôpital Laënnec, France; Paracelsus-Elena-Klinik Kassel (F.S.-D., C.T.); Department of Neurosurgery (C.T.), University Medical Center Göttingen; Division of Functional and Restorative Neurosurgery and Centre for Integrative Neuroscience (A.G.), Tübingen; Abteilung für Neurologie (T.W.), Reha-Zentrum Bad Gögging, Passauer Wolf; Department for Neurodegenerative Diseases and Hertie Institute for Clinical Brain Research (D.W.), University of Tübingen; Division of Stereotactic and Functional Neurosurgery (M.O.P.), University Medical Center Freiburg, Germany; Departments of Functional and Stereotactic Neurosurgery and Radiosurgery (J.-.M.R.) and Neurology (T.W.), Timone University Hospital, INSERM, Marseille; Institut des Sciences Cognitives Marc Jeannerod (S.T.), CNRS, UMR 5229, Université de Lyon; Centre Expert Parkinson (S.T.), Service de Neurologie C, Hôpital Neurologique Pierre Wertheimer, Hospices Civils de Lyon, Bron; Department of Neurosurgery (P.M.), University Hospital of Neurology and Neurosurgery, Hospices Civils de Lyon, Université de Lyon; Department of Neurology (J.-L.H.), INSERM-1402, Centre Hospitalier Universitaire de Poitiers, University of Poitiers, France; and Universitätsklinikum Giessen und Marburg (L.T.), Marburg Campus, Germany.""}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Paschen', 'Affiliation': ""From the Département de Neurologie (W.M.M.S., A.H., T.D.H., F.P., Y.A., M.V.), Hôpital Pitié-Salpêtrière, Centre d'Investigation Clinique 1422, Institut du Cerveau et de la Moelle Epinière, Institut National de Santé et en Recherche Médicale, Assistance Publique Hôpitaux de Paris, France; Institute of Neurology (W.M.M.S.), Konolfingen; Department of Neurology (W.M.M.S.), University Hospital Bern and University of Bern, Switzerland; Medtronic (L.T.), Minneapolis, MN; Institute of Clinical Neuroscience & Medical Psychology and Department of Neurology (A.D., L.W.), Medical Faculty, Heinrich-Heine-University Düsseldorf, Germany; Movement Disorder Unit, Neurology (P.K.), CHU Grenoble Alpes; Grenoble Institut des Neurosciences (P.K., V.F., A. Kistner), University Grenoble Alpes; Inserm U1216 (P.K., V.F., A. Kistner), Grenoble, France; Department of Clinical Neurosciences (Neurology) (P.K.), Faculty of Medicine, University of Geneva, Switzerland; Coordinating Center for clinical trials of the Philipps University of Marburg (J.R., C.S.-B.); Neurochirurgische Klinik im Neurozentrum (A.F., L.P., S.P., J. Volkmann, K.K., G.D.),Christian-Albrechts-Universität Kiel; Neurologische Klinik und Poliklinik (J. Volkmann), Universitätsklinikum Würzburg; Department of Neurology (H.S.D., M.T.B., G.R.F., L.T.), University Hospital Cologne; Research Centre Jülich (G.R.F.); Klinik für Neurologie (T.D.H., A. Kühn, A. Kupsch) and Klinik für Neurochirurgie (G.-H.S.), Campus Virchow, Charité-Universitätsmedizin Berlin; Praxis Kupsch (A. Kupsch), Berlin, Germany; Service de Neurochirurgie (E.S.) and Service de Neurologie (V.F.), Hôpital Michallon, Centre Hospitalo-Universitaire, Grenoble; Departments of Neurosurgery (P.P.C.), Neurology (F.O.-M., C.B.-C.), and Clinical Pharmacology (C.B.-C.), University Hospital of Toulouse; ToNIC (F.O.-M., C.B.-C.), Toulouse Neuroimaging Center, University of Toulouse, Inserm, UPS, France; Department of Neurosurgery (J. Vesper), Universitätsklinikum Düsseldorf, Germany; Departments of Neurosurgery (S.D.) and Neurology (D.M.), Rouen University Hospital and University of Rouen; INSERM U1239 (D.M.), Laboratory of Neuronal and Neuroendocrine Differentiation and Communication, Mont-Saint-Aignan; Service de Neurologie (P. Damier, P. Derkinderen), CHU Nantes, Hôpital Laënnec, France; Paracelsus-Elena-Klinik Kassel (F.S.-D., C.T.); Department of Neurosurgery (C.T.), University Medical Center Göttingen; Division of Functional and Restorative Neurosurgery and Centre for Integrative Neuroscience (A.G.), Tübingen; Abteilung für Neurologie (T.W.), Reha-Zentrum Bad Gögging, Passauer Wolf; Department for Neurodegenerative Diseases and Hertie Institute for Clinical Brain Research (D.W.), University of Tübingen; Division of Stereotactic and Functional Neurosurgery (M.O.P.), University Medical Center Freiburg, Germany; Departments of Functional and Stereotactic Neurosurgery and Radiosurgery (J.-.M.R.) and Neurology (T.W.), Timone University Hospital, INSERM, Marseille; Institut des Sciences Cognitives Marc Jeannerod (S.T.), CNRS, UMR 5229, Université de Lyon; Centre Expert Parkinson (S.T.), Service de Neurologie C, Hôpital Neurologique Pierre Wertheimer, Hospices Civils de Lyon, Bron; Department of Neurosurgery (P.M.), University Hospital of Neurology and Neurosurgery, Hospices Civils de Lyon, Université de Lyon; Department of Neurology (J.-L.H.), INSERM-1402, Centre Hospitalier Universitaire de Poitiers, University of Poitiers, France; and Universitätsklinikum Giessen und Marburg (L.T.), Marburg Campus, Germany.""}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Volkmann', 'Affiliation': ""From the Département de Neurologie (W.M.M.S., A.H., T.D.H., F.P., Y.A., M.V.), Hôpital Pitié-Salpêtrière, Centre d'Investigation Clinique 1422, Institut du Cerveau et de la Moelle Epinière, Institut National de Santé et en Recherche Médicale, Assistance Publique Hôpitaux de Paris, France; Institute of Neurology (W.M.M.S.), Konolfingen; Department of Neurology (W.M.M.S.), University Hospital Bern and University of Bern, Switzerland; Medtronic (L.T.), Minneapolis, MN; Institute of Clinical Neuroscience & Medical Psychology and Department of Neurology (A.D., L.W.), Medical Faculty, Heinrich-Heine-University Düsseldorf, Germany; Movement Disorder Unit, Neurology (P.K.), CHU Grenoble Alpes; Grenoble Institut des Neurosciences (P.K., V.F., A. Kistner), University Grenoble Alpes; Inserm U1216 (P.K., V.F., A. Kistner), Grenoble, France; Department of Clinical Neurosciences (Neurology) (P.K.), Faculty of Medicine, University of Geneva, Switzerland; Coordinating Center for clinical trials of the Philipps University of Marburg (J.R., C.S.-B.); Neurochirurgische Klinik im Neurozentrum (A.F., L.P., S.P., J. Volkmann, K.K., G.D.),Christian-Albrechts-Universität Kiel; Neurologische Klinik und Poliklinik (J. Volkmann), Universitätsklinikum Würzburg; Department of Neurology (H.S.D., M.T.B., G.R.F., L.T.), University Hospital Cologne; Research Centre Jülich (G.R.F.); Klinik für Neurologie (T.D.H., A. Kühn, A. Kupsch) and Klinik für Neurochirurgie (G.-H.S.), Campus Virchow, Charité-Universitätsmedizin Berlin; Praxis Kupsch (A. Kupsch), Berlin, Germany; Service de Neurochirurgie (E.S.) and Service de Neurologie (V.F.), Hôpital Michallon, Centre Hospitalo-Universitaire, Grenoble; Departments of Neurosurgery (P.P.C.), Neurology (F.O.-M., C.B.-C.), and Clinical Pharmacology (C.B.-C.), University Hospital of Toulouse; ToNIC (F.O.-M., C.B.-C.), Toulouse Neuroimaging Center, University of Toulouse, Inserm, UPS, France; Department of Neurosurgery (J. Vesper), Universitätsklinikum Düsseldorf, Germany; Departments of Neurosurgery (S.D.) and Neurology (D.M.), Rouen University Hospital and University of Rouen; INSERM U1239 (D.M.), Laboratory of Neuronal and Neuroendocrine Differentiation and Communication, Mont-Saint-Aignan; Service de Neurologie (P. Damier, P. Derkinderen), CHU Nantes, Hôpital Laënnec, France; Paracelsus-Elena-Klinik Kassel (F.S.-D., C.T.); Department of Neurosurgery (C.T.), University Medical Center Göttingen; Division of Functional and Restorative Neurosurgery and Centre for Integrative Neuroscience (A.G.), Tübingen; Abteilung für Neurologie (T.W.), Reha-Zentrum Bad Gögging, Passauer Wolf; Department for Neurodegenerative Diseases and Hertie Institute for Clinical Brain Research (D.W.), University of Tübingen; Division of Stereotactic and Functional Neurosurgery (M.O.P.), University Medical Center Freiburg, Germany; Departments of Functional and Stereotactic Neurosurgery and Radiosurgery (J.-.M.R.) and Neurology (T.W.), Timone University Hospital, INSERM, Marseille; Institut des Sciences Cognitives Marc Jeannerod (S.T.), CNRS, UMR 5229, Université de Lyon; Centre Expert Parkinson (S.T.), Service de Neurologie C, Hôpital Neurologique Pierre Wertheimer, Hospices Civils de Lyon, Bron; Department of Neurosurgery (P.M.), University Hospital of Neurology and Neurosurgery, Hospices Civils de Lyon, Université de Lyon; Department of Neurology (J.-L.H.), INSERM-1402, Centre Hospitalier Universitaire de Poitiers, University of Poitiers, France; and Universitätsklinikum Giessen und Marburg (L.T.), Marburg Campus, Germany.""}, {'ForeName': 'Haidar S', 'Initials': 'HS', 'LastName': 'Dafsari', 'Affiliation': ""From the Département de Neurologie (W.M.M.S., A.H., T.D.H., F.P., Y.A., M.V.), Hôpital Pitié-Salpêtrière, Centre d'Investigation Clinique 1422, Institut du Cerveau et de la Moelle Epinière, Institut National de Santé et en Recherche Médicale, Assistance Publique Hôpitaux de Paris, France; Institute of Neurology (W.M.M.S.), Konolfingen; Department of Neurology (W.M.M.S.), University Hospital Bern and University of Bern, Switzerland; Medtronic (L.T.), Minneapolis, MN; Institute of Clinical Neuroscience & Medical Psychology and Department of Neurology (A.D., L.W.), Medical Faculty, Heinrich-Heine-University Düsseldorf, Germany; Movement Disorder Unit, Neurology (P.K.), CHU Grenoble Alpes; Grenoble Institut des Neurosciences (P.K., V.F., A. Kistner), University Grenoble Alpes; Inserm U1216 (P.K., V.F., A. Kistner), Grenoble, France; Department of Clinical Neurosciences (Neurology) (P.K.), Faculty of Medicine, University of Geneva, Switzerland; Coordinating Center for clinical trials of the Philipps University of Marburg (J.R., C.S.-B.); Neurochirurgische Klinik im Neurozentrum (A.F., L.P., S.P., J. Volkmann, K.K., G.D.),Christian-Albrechts-Universität Kiel; Neurologische Klinik und Poliklinik (J. Volkmann), Universitätsklinikum Würzburg; Department of Neurology (H.S.D., M.T.B., G.R.F., L.T.), University Hospital Cologne; Research Centre Jülich (G.R.F.); Klinik für Neurologie (T.D.H., A. Kühn, A. Kupsch) and Klinik für Neurochirurgie (G.-H.S.), Campus Virchow, Charité-Universitätsmedizin Berlin; Praxis Kupsch (A. Kupsch), Berlin, Germany; Service de Neurochirurgie (E.S.) and Service de Neurologie (V.F.), Hôpital Michallon, Centre Hospitalo-Universitaire, Grenoble; Departments of Neurosurgery (P.P.C.), Neurology (F.O.-M., C.B.-C.), and Clinical Pharmacology (C.B.-C.), University Hospital of Toulouse; ToNIC (F.O.-M., C.B.-C.), Toulouse Neuroimaging Center, University of Toulouse, Inserm, UPS, France; Department of Neurosurgery (J. Vesper), Universitätsklinikum Düsseldorf, Germany; Departments of Neurosurgery (S.D.) and Neurology (D.M.), Rouen University Hospital and University of Rouen; INSERM U1239 (D.M.), Laboratory of Neuronal and Neuroendocrine Differentiation and Communication, Mont-Saint-Aignan; Service de Neurologie (P. Damier, P. Derkinderen), CHU Nantes, Hôpital Laënnec, France; Paracelsus-Elena-Klinik Kassel (F.S.-D., C.T.); Department of Neurosurgery (C.T.), University Medical Center Göttingen; Division of Functional and Restorative Neurosurgery and Centre for Integrative Neuroscience (A.G.), Tübingen; Abteilung für Neurologie (T.W.), Reha-Zentrum Bad Gögging, Passauer Wolf; Department for Neurodegenerative Diseases and Hertie Institute for Clinical Brain Research (D.W.), University of Tübingen; Division of Stereotactic and Functional Neurosurgery (M.O.P.), University Medical Center Freiburg, Germany; Departments of Functional and Stereotactic Neurosurgery and Radiosurgery (J.-.M.R.) and Neurology (T.W.), Timone University Hospital, INSERM, Marseille; Institut des Sciences Cognitives Marc Jeannerod (S.T.), CNRS, UMR 5229, Université de Lyon; Centre Expert Parkinson (S.T.), Service de Neurologie C, Hôpital Neurologique Pierre Wertheimer, Hospices Civils de Lyon, Bron; Department of Neurosurgery (P.M.), University Hospital of Neurology and Neurosurgery, Hospices Civils de Lyon, Université de Lyon; Department of Neurology (J.-L.H.), INSERM-1402, Centre Hospitalier Universitaire de Poitiers, University of Poitiers, France; and Universitätsklinikum Giessen und Marburg (L.T.), Marburg Campus, Germany.""}, {'ForeName': 'Michael T', 'Initials': 'MT', 'LastName': 'Barbe', 'Affiliation': ""From the Département de Neurologie (W.M.M.S., A.H., T.D.H., F.P., Y.A., M.V.), Hôpital Pitié-Salpêtrière, Centre d'Investigation Clinique 1422, Institut du Cerveau et de la Moelle Epinière, Institut National de Santé et en Recherche Médicale, Assistance Publique Hôpitaux de Paris, France; Institute of Neurology (W.M.M.S.), Konolfingen; Department of Neurology (W.M.M.S.), University Hospital Bern and University of Bern, Switzerland; Medtronic (L.T.), Minneapolis, MN; Institute of Clinical Neuroscience & Medical Psychology and Department of Neurology (A.D., L.W.), Medical Faculty, Heinrich-Heine-University Düsseldorf, Germany; Movement Disorder Unit, Neurology (P.K.), CHU Grenoble Alpes; Grenoble Institut des Neurosciences (P.K., V.F., A. Kistner), University Grenoble Alpes; Inserm U1216 (P.K., V.F., A. Kistner), Grenoble, France; Department of Clinical Neurosciences (Neurology) (P.K.), Faculty of Medicine, University of Geneva, Switzerland; Coordinating Center for clinical trials of the Philipps University of Marburg (J.R., C.S.-B.); Neurochirurgische Klinik im Neurozentrum (A.F., L.P., S.P., J. Volkmann, K.K., G.D.),Christian-Albrechts-Universität Kiel; Neurologische Klinik und Poliklinik (J. Volkmann), Universitätsklinikum Würzburg; Department of Neurology (H.S.D., M.T.B., G.R.F., L.T.), University Hospital Cologne; Research Centre Jülich (G.R.F.); Klinik für Neurologie (T.D.H., A. Kühn, A. Kupsch) and Klinik für Neurochirurgie (G.-H.S.), Campus Virchow, Charité-Universitätsmedizin Berlin; Praxis Kupsch (A. Kupsch), Berlin, Germany; Service de Neurochirurgie (E.S.) and Service de Neurologie (V.F.), Hôpital Michallon, Centre Hospitalo-Universitaire, Grenoble; Departments of Neurosurgery (P.P.C.), Neurology (F.O.-M., C.B.-C.), and Clinical Pharmacology (C.B.-C.), University Hospital of Toulouse; ToNIC (F.O.-M., C.B.-C.), Toulouse Neuroimaging Center, University of Toulouse, Inserm, UPS, France; Department of Neurosurgery (J. Vesper), Universitätsklinikum Düsseldorf, Germany; Departments of Neurosurgery (S.D.) and Neurology (D.M.), Rouen University Hospital and University of Rouen; INSERM U1239 (D.M.), Laboratory of Neuronal and Neuroendocrine Differentiation and Communication, Mont-Saint-Aignan; Service de Neurologie (P. Damier, P. Derkinderen), CHU Nantes, Hôpital Laënnec, France; Paracelsus-Elena-Klinik Kassel (F.S.-D., C.T.); Department of Neurosurgery (C.T.), University Medical Center Göttingen; Division of Functional and Restorative Neurosurgery and Centre for Integrative Neuroscience (A.G.), Tübingen; Abteilung für Neurologie (T.W.), Reha-Zentrum Bad Gögging, Passauer Wolf; Department for Neurodegenerative Diseases and Hertie Institute for Clinical Brain Research (D.W.), University of Tübingen; Division of Stereotactic and Functional Neurosurgery (M.O.P.), University Medical Center Freiburg, Germany; Departments of Functional and Stereotactic Neurosurgery and Radiosurgery (J.-.M.R.) and Neurology (T.W.), Timone University Hospital, INSERM, Marseille; Institut des Sciences Cognitives Marc Jeannerod (S.T.), CNRS, UMR 5229, Université de Lyon; Centre Expert Parkinson (S.T.), Service de Neurologie C, Hôpital Neurologique Pierre Wertheimer, Hospices Civils de Lyon, Bron; Department of Neurosurgery (P.M.), University Hospital of Neurology and Neurosurgery, Hospices Civils de Lyon, Université de Lyon; Department of Neurology (J.-L.H.), INSERM-1402, Centre Hospitalier Universitaire de Poitiers, University of Poitiers, France; and Universitätsklinikum Giessen und Marburg (L.T.), Marburg Campus, Germany.""}, {'ForeName': 'Gereon R', 'Initials': 'GR', 'LastName': 'Fink', 'Affiliation': ""From the Département de Neurologie (W.M.M.S., A.H., T.D.H., F.P., Y.A., M.V.), Hôpital Pitié-Salpêtrière, Centre d'Investigation Clinique 1422, Institut du Cerveau et de la Moelle Epinière, Institut National de Santé et en Recherche Médicale, Assistance Publique Hôpitaux de Paris, France; Institute of Neurology (W.M.M.S.), Konolfingen; Department of Neurology (W.M.M.S.), University Hospital Bern and University of Bern, Switzerland; Medtronic (L.T.), Minneapolis, MN; Institute of Clinical Neuroscience & Medical Psychology and Department of Neurology (A.D., L.W.), Medical Faculty, Heinrich-Heine-University Düsseldorf, Germany; Movement Disorder Unit, Neurology (P.K.), CHU Grenoble Alpes; Grenoble Institut des Neurosciences (P.K., V.F., A. Kistner), University Grenoble Alpes; Inserm U1216 (P.K., V.F., A. Kistner), Grenoble, France; Department of Clinical Neurosciences (Neurology) (P.K.), Faculty of Medicine, University of Geneva, Switzerland; Coordinating Center for clinical trials of the Philipps University of Marburg (J.R., C.S.-B.); Neurochirurgische Klinik im Neurozentrum (A.F., L.P., S.P., J. Volkmann, K.K., G.D.),Christian-Albrechts-Universität Kiel; Neurologische Klinik und Poliklinik (J. Volkmann), Universitätsklinikum Würzburg; Department of Neurology (H.S.D., M.T.B., G.R.F., L.T.), University Hospital Cologne; Research Centre Jülich (G.R.F.); Klinik für Neurologie (T.D.H., A. Kühn, A. Kupsch) and Klinik für Neurochirurgie (G.-H.S.), Campus Virchow, Charité-Universitätsmedizin Berlin; Praxis Kupsch (A. Kupsch), Berlin, Germany; Service de Neurochirurgie (E.S.) and Service de Neurologie (V.F.), Hôpital Michallon, Centre Hospitalo-Universitaire, Grenoble; Departments of Neurosurgery (P.P.C.), Neurology (F.O.-M., C.B.-C.), and Clinical Pharmacology (C.B.-C.), University Hospital of Toulouse; ToNIC (F.O.-M., C.B.-C.), Toulouse Neuroimaging Center, University of Toulouse, Inserm, UPS, France; Department of Neurosurgery (J. Vesper), Universitätsklinikum Düsseldorf, Germany; Departments of Neurosurgery (S.D.) and Neurology (D.M.), Rouen University Hospital and University of Rouen; INSERM U1239 (D.M.), Laboratory of Neuronal and Neuroendocrine Differentiation and Communication, Mont-Saint-Aignan; Service de Neurologie (P. Damier, P. Derkinderen), CHU Nantes, Hôpital Laënnec, France; Paracelsus-Elena-Klinik Kassel (F.S.-D., C.T.); Department of Neurosurgery (C.T.), University Medical Center Göttingen; Division of Functional and Restorative Neurosurgery and Centre for Integrative Neuroscience (A.G.), Tübingen; Abteilung für Neurologie (T.W.), Reha-Zentrum Bad Gögging, Passauer Wolf; Department for Neurodegenerative Diseases and Hertie Institute for Clinical Brain Research (D.W.), University of Tübingen; Division of Stereotactic and Functional Neurosurgery (M.O.P.), University Medical Center Freiburg, Germany; Departments of Functional and Stereotactic Neurosurgery and Radiosurgery (J.-.M.R.) and Neurology (T.W.), Timone University Hospital, INSERM, Marseille; Institut des Sciences Cognitives Marc Jeannerod (S.T.), CNRS, UMR 5229, Université de Lyon; Centre Expert Parkinson (S.T.), Service de Neurologie C, Hôpital Neurologique Pierre Wertheimer, Hospices Civils de Lyon, Bron; Department of Neurosurgery (P.M.), University Hospital of Neurology and Neurosurgery, Hospices Civils de Lyon, Université de Lyon; Department of Neurology (J.-L.H.), INSERM-1402, Centre Hospitalier Universitaire de Poitiers, University of Poitiers, France; and Universitätsklinikum Giessen und Marburg (L.T.), Marburg Campus, Germany.""}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Kühn', 'Affiliation': ""From the Département de Neurologie (W.M.M.S., A.H., T.D.H., F.P., Y.A., M.V.), Hôpital Pitié-Salpêtrière, Centre d'Investigation Clinique 1422, Institut du Cerveau et de la Moelle Epinière, Institut National de Santé et en Recherche Médicale, Assistance Publique Hôpitaux de Paris, France; Institute of Neurology (W.M.M.S.), Konolfingen; Department of Neurology (W.M.M.S.), University Hospital Bern and University of Bern, Switzerland; Medtronic (L.T.), Minneapolis, MN; Institute of Clinical Neuroscience & Medical Psychology and Department of Neurology (A.D., L.W.), Medical Faculty, Heinrich-Heine-University Düsseldorf, Germany; Movement Disorder Unit, Neurology (P.K.), CHU Grenoble Alpes; Grenoble Institut des Neurosciences (P.K., V.F., A. Kistner), University Grenoble Alpes; Inserm U1216 (P.K., V.F., A. Kistner), Grenoble, France; Department of Clinical Neurosciences (Neurology) (P.K.), Faculty of Medicine, University of Geneva, Switzerland; Coordinating Center for clinical trials of the Philipps University of Marburg (J.R., C.S.-B.); Neurochirurgische Klinik im Neurozentrum (A.F., L.P., S.P., J. Volkmann, K.K., G.D.),Christian-Albrechts-Universität Kiel; Neurologische Klinik und Poliklinik (J. Volkmann), Universitätsklinikum Würzburg; Department of Neurology (H.S.D., M.T.B., G.R.F., L.T.), University Hospital Cologne; Research Centre Jülich (G.R.F.); Klinik für Neurologie (T.D.H., A. Kühn, A. Kupsch) and Klinik für Neurochirurgie (G.-H.S.), Campus Virchow, Charité-Universitätsmedizin Berlin; Praxis Kupsch (A. Kupsch), Berlin, Germany; Service de Neurochirurgie (E.S.) and Service de Neurologie (V.F.), Hôpital Michallon, Centre Hospitalo-Universitaire, Grenoble; Departments of Neurosurgery (P.P.C.), Neurology (F.O.-M., C.B.-C.), and Clinical Pharmacology (C.B.-C.), University Hospital of Toulouse; ToNIC (F.O.-M., C.B.-C.), Toulouse Neuroimaging Center, University of Toulouse, Inserm, UPS, France; Department of Neurosurgery (J. Vesper), Universitätsklinikum Düsseldorf, Germany; Departments of Neurosurgery (S.D.) and Neurology (D.M.), Rouen University Hospital and University of Rouen; INSERM U1239 (D.M.), Laboratory of Neuronal and Neuroendocrine Differentiation and Communication, Mont-Saint-Aignan; Service de Neurologie (P. Damier, P. Derkinderen), CHU Nantes, Hôpital Laënnec, France; Paracelsus-Elena-Klinik Kassel (F.S.-D., C.T.); Department of Neurosurgery (C.T.), University Medical Center Göttingen; Division of Functional and Restorative Neurosurgery and Centre for Integrative Neuroscience (A.G.), Tübingen; Abteilung für Neurologie (T.W.), Reha-Zentrum Bad Gögging, Passauer Wolf; Department for Neurodegenerative Diseases and Hertie Institute for Clinical Brain Research (D.W.), University of Tübingen; Division of Stereotactic and Functional Neurosurgery (M.O.P.), University Medical Center Freiburg, Germany; Departments of Functional and Stereotactic Neurosurgery and Radiosurgery (J.-.M.R.) and Neurology (T.W.), Timone University Hospital, INSERM, Marseille; Institut des Sciences Cognitives Marc Jeannerod (S.T.), CNRS, UMR 5229, Université de Lyon; Centre Expert Parkinson (S.T.), Service de Neurologie C, Hôpital Neurologique Pierre Wertheimer, Hospices Civils de Lyon, Bron; Department of Neurosurgery (P.M.), University Hospital of Neurology and Neurosurgery, Hospices Civils de Lyon, Université de Lyon; Department of Neurology (J.-L.H.), INSERM-1402, Centre Hospitalier Universitaire de Poitiers, University of Poitiers, France; and Universitätsklinikum Giessen und Marburg (L.T.), Marburg Campus, Germany.""}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Kupsch', 'Affiliation': ""From the Département de Neurologie (W.M.M.S., A.H., T.D.H., F.P., Y.A., M.V.), Hôpital Pitié-Salpêtrière, Centre d'Investigation Clinique 1422, Institut du Cerveau et de la Moelle Epinière, Institut National de Santé et en Recherche Médicale, Assistance Publique Hôpitaux de Paris, France; Institute of Neurology (W.M.M.S.), Konolfingen; Department of Neurology (W.M.M.S.), University Hospital Bern and University of Bern, Switzerland; Medtronic (L.T.), Minneapolis, MN; Institute of Clinical Neuroscience & Medical Psychology and Department of Neurology (A.D., L.W.), Medical Faculty, Heinrich-Heine-University Düsseldorf, Germany; Movement Disorder Unit, Neurology (P.K.), CHU Grenoble Alpes; Grenoble Institut des Neurosciences (P.K., V.F., A. Kistner), University Grenoble Alpes; Inserm U1216 (P.K., V.F., A. Kistner), Grenoble, France; Department of Clinical Neurosciences (Neurology) (P.K.), Faculty of Medicine, University of Geneva, Switzerland; Coordinating Center for clinical trials of the Philipps University of Marburg (J.R., C.S.-B.); Neurochirurgische Klinik im Neurozentrum (A.F., L.P., S.P., J. Volkmann, K.K., G.D.),Christian-Albrechts-Universität Kiel; Neurologische Klinik und Poliklinik (J. Volkmann), Universitätsklinikum Würzburg; Department of Neurology (H.S.D., M.T.B., G.R.F., L.T.), University Hospital Cologne; Research Centre Jülich (G.R.F.); Klinik für Neurologie (T.D.H., A. Kühn, A. Kupsch) and Klinik für Neurochirurgie (G.-H.S.), Campus Virchow, Charité-Universitätsmedizin Berlin; Praxis Kupsch (A. Kupsch), Berlin, Germany; Service de Neurochirurgie (E.S.) and Service de Neurologie (V.F.), Hôpital Michallon, Centre Hospitalo-Universitaire, Grenoble; Departments of Neurosurgery (P.P.C.), Neurology (F.O.-M., C.B.-C.), and Clinical Pharmacology (C.B.-C.), University Hospital of Toulouse; ToNIC (F.O.-M., C.B.-C.), Toulouse Neuroimaging Center, University of Toulouse, Inserm, UPS, France; Department of Neurosurgery (J. Vesper), Universitätsklinikum Düsseldorf, Germany; Departments of Neurosurgery (S.D.) and Neurology (D.M.), Rouen University Hospital and University of Rouen; INSERM U1239 (D.M.), Laboratory of Neuronal and Neuroendocrine Differentiation and Communication, Mont-Saint-Aignan; Service de Neurologie (P. Damier, P. Derkinderen), CHU Nantes, Hôpital Laënnec, France; Paracelsus-Elena-Klinik Kassel (F.S.-D., C.T.); Department of Neurosurgery (C.T.), University Medical Center Göttingen; Division of Functional and Restorative Neurosurgery and Centre for Integrative Neuroscience (A.G.), Tübingen; Abteilung für Neurologie (T.W.), Reha-Zentrum Bad Gögging, Passauer Wolf; Department for Neurodegenerative Diseases and Hertie Institute for Clinical Brain Research (D.W.), University of Tübingen; Division of Stereotactic and Functional Neurosurgery (M.O.P.), University Medical Center Freiburg, Germany; Departments of Functional and Stereotactic Neurosurgery and Radiosurgery (J.-.M.R.) and Neurology (T.W.), Timone University Hospital, INSERM, Marseille; Institut des Sciences Cognitives Marc Jeannerod (S.T.), CNRS, UMR 5229, Université de Lyon; Centre Expert Parkinson (S.T.), Service de Neurologie C, Hôpital Neurologique Pierre Wertheimer, Hospices Civils de Lyon, Bron; Department of Neurosurgery (P.M.), University Hospital of Neurology and Neurosurgery, Hospices Civils de Lyon, Université de Lyon; Department of Neurology (J.-L.H.), INSERM-1402, Centre Hospitalier Universitaire de Poitiers, University of Poitiers, France; and Universitätsklinikum Giessen und Marburg (L.T.), Marburg Campus, Germany.""}, {'ForeName': 'Gerd-H', 'Initials': 'GH', 'LastName': 'Schneider', 'Affiliation': ""From the Département de Neurologie (W.M.M.S., A.H., T.D.H., F.P., Y.A., M.V.), Hôpital Pitié-Salpêtrière, Centre d'Investigation Clinique 1422, Institut du Cerveau et de la Moelle Epinière, Institut National de Santé et en Recherche Médicale, Assistance Publique Hôpitaux de Paris, France; Institute of Neurology (W.M.M.S.), Konolfingen; Department of Neurology (W.M.M.S.), University Hospital Bern and University of Bern, Switzerland; Medtronic (L.T.), Minneapolis, MN; Institute of Clinical Neuroscience & Medical Psychology and Department of Neurology (A.D., L.W.), Medical Faculty, Heinrich-Heine-University Düsseldorf, Germany; Movement Disorder Unit, Neurology (P.K.), CHU Grenoble Alpes; Grenoble Institut des Neurosciences (P.K., V.F., A. Kistner), University Grenoble Alpes; Inserm U1216 (P.K., V.F., A. Kistner), Grenoble, France; Department of Clinical Neurosciences (Neurology) (P.K.), Faculty of Medicine, University of Geneva, Switzerland; Coordinating Center for clinical trials of the Philipps University of Marburg (J.R., C.S.-B.); Neurochirurgische Klinik im Neurozentrum (A.F., L.P., S.P., J. Volkmann, K.K., G.D.),Christian-Albrechts-Universität Kiel; Neurologische Klinik und Poliklinik (J. Volkmann), Universitätsklinikum Würzburg; Department of Neurology (H.S.D., M.T.B., G.R.F., L.T.), University Hospital Cologne; Research Centre Jülich (G.R.F.); Klinik für Neurologie (T.D.H., A. Kühn, A. Kupsch) and Klinik für Neurochirurgie (G.-H.S.), Campus Virchow, Charité-Universitätsmedizin Berlin; Praxis Kupsch (A. Kupsch), Berlin, Germany; Service de Neurochirurgie (E.S.) and Service de Neurologie (V.F.), Hôpital Michallon, Centre Hospitalo-Universitaire, Grenoble; Departments of Neurosurgery (P.P.C.), Neurology (F.O.-M., C.B.-C.), and Clinical Pharmacology (C.B.-C.), University Hospital of Toulouse; ToNIC (F.O.-M., C.B.-C.), Toulouse Neuroimaging Center, University of Toulouse, Inserm, UPS, France; Department of Neurosurgery (J. Vesper), Universitätsklinikum Düsseldorf, Germany; Departments of Neurosurgery (S.D.) and Neurology (D.M.), Rouen University Hospital and University of Rouen; INSERM U1239 (D.M.), Laboratory of Neuronal and Neuroendocrine Differentiation and Communication, Mont-Saint-Aignan; Service de Neurologie (P. Damier, P. Derkinderen), CHU Nantes, Hôpital Laënnec, France; Paracelsus-Elena-Klinik Kassel (F.S.-D., C.T.); Department of Neurosurgery (C.T.), University Medical Center Göttingen; Division of Functional and Restorative Neurosurgery and Centre for Integrative Neuroscience (A.G.), Tübingen; Abteilung für Neurologie (T.W.), Reha-Zentrum Bad Gögging, Passauer Wolf; Department for Neurodegenerative Diseases and Hertie Institute for Clinical Brain Research (D.W.), University of Tübingen; Division of Stereotactic and Functional Neurosurgery (M.O.P.), University Medical Center Freiburg, Germany; Departments of Functional and Stereotactic Neurosurgery and Radiosurgery (J.-.M.R.) and Neurology (T.W.), Timone University Hospital, INSERM, Marseille; Institut des Sciences Cognitives Marc Jeannerod (S.T.), CNRS, UMR 5229, Université de Lyon; Centre Expert Parkinson (S.T.), Service de Neurologie C, Hôpital Neurologique Pierre Wertheimer, Hospices Civils de Lyon, Bron; Department of Neurosurgery (P.M.), University Hospital of Neurology and Neurosurgery, Hospices Civils de Lyon, Université de Lyon; Department of Neurology (J.-L.H.), INSERM-1402, Centre Hospitalier Universitaire de Poitiers, University of Poitiers, France; and Universitätsklinikum Giessen und Marburg (L.T.), Marburg Campus, Germany.""}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Seigneuret', 'Affiliation': ""From the Département de Neurologie (W.M.M.S., A.H., T.D.H., F.P., Y.A., M.V.), Hôpital Pitié-Salpêtrière, Centre d'Investigation Clinique 1422, Institut du Cerveau et de la Moelle Epinière, Institut National de Santé et en Recherche Médicale, Assistance Publique Hôpitaux de Paris, France; Institute of Neurology (W.M.M.S.), Konolfingen; Department of Neurology (W.M.M.S.), University Hospital Bern and University of Bern, Switzerland; Medtronic (L.T.), Minneapolis, MN; Institute of Clinical Neuroscience & Medical Psychology and Department of Neurology (A.D., L.W.), Medical Faculty, Heinrich-Heine-University Düsseldorf, Germany; Movement Disorder Unit, Neurology (P.K.), CHU Grenoble Alpes; Grenoble Institut des Neurosciences (P.K., V.F., A. Kistner), University Grenoble Alpes; Inserm U1216 (P.K., V.F., A. Kistner), Grenoble, France; Department of Clinical Neurosciences (Neurology) (P.K.), Faculty of Medicine, University of Geneva, Switzerland; Coordinating Center for clinical trials of the Philipps University of Marburg (J.R., C.S.-B.); Neurochirurgische Klinik im Neurozentrum (A.F., L.P., S.P., J. Volkmann, K.K., G.D.),Christian-Albrechts-Universität Kiel; Neurologische Klinik und Poliklinik (J. Volkmann), Universitätsklinikum Würzburg; Department of Neurology (H.S.D., M.T.B., G.R.F., L.T.), University Hospital Cologne; Research Centre Jülich (G.R.F.); Klinik für Neurologie (T.D.H., A. Kühn, A. Kupsch) and Klinik für Neurochirurgie (G.-H.S.), Campus Virchow, Charité-Universitätsmedizin Berlin; Praxis Kupsch (A. Kupsch), Berlin, Germany; Service de Neurochirurgie (E.S.) and Service de Neurologie (V.F.), Hôpital Michallon, Centre Hospitalo-Universitaire, Grenoble; Departments of Neurosurgery (P.P.C.), Neurology (F.O.-M., C.B.-C.), and Clinical Pharmacology (C.B.-C.), University Hospital of Toulouse; ToNIC (F.O.-M., C.B.-C.), Toulouse Neuroimaging Center, University of Toulouse, Inserm, UPS, France; Department of Neurosurgery (J. Vesper), Universitätsklinikum Düsseldorf, Germany; Departments of Neurosurgery (S.D.) and Neurology (D.M.), Rouen University Hospital and University of Rouen; INSERM U1239 (D.M.), Laboratory of Neuronal and Neuroendocrine Differentiation and Communication, Mont-Saint-Aignan; Service de Neurologie (P. Damier, P. Derkinderen), CHU Nantes, Hôpital Laënnec, France; Paracelsus-Elena-Klinik Kassel (F.S.-D., C.T.); Department of Neurosurgery (C.T.), University Medical Center Göttingen; Division of Functional and Restorative Neurosurgery and Centre for Integrative Neuroscience (A.G.), Tübingen; Abteilung für Neurologie (T.W.), Reha-Zentrum Bad Gögging, Passauer Wolf; Department for Neurodegenerative Diseases and Hertie Institute for Clinical Brain Research (D.W.), University of Tübingen; Division of Stereotactic and Functional Neurosurgery (M.O.P.), University Medical Center Freiburg, Germany; Departments of Functional and Stereotactic Neurosurgery and Radiosurgery (J.-.M.R.) and Neurology (T.W.), Timone University Hospital, INSERM, Marseille; Institut des Sciences Cognitives Marc Jeannerod (S.T.), CNRS, UMR 5229, Université de Lyon; Centre Expert Parkinson (S.T.), Service de Neurologie C, Hôpital Neurologique Pierre Wertheimer, Hospices Civils de Lyon, Bron; Department of Neurosurgery (P.M.), University Hospital of Neurology and Neurosurgery, Hospices Civils de Lyon, Université de Lyon; Department of Neurology (J.-L.H.), INSERM-1402, Centre Hospitalier Universitaire de Poitiers, University of Poitiers, France; and Universitätsklinikum Giessen und Marburg (L.T.), Marburg Campus, Germany.""}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Fraix', 'Affiliation': ""From the Département de Neurologie (W.M.M.S., A.H., T.D.H., F.P., Y.A., M.V.), Hôpital Pitié-Salpêtrière, Centre d'Investigation Clinique 1422, Institut du Cerveau et de la Moelle Epinière, Institut National de Santé et en Recherche Médicale, Assistance Publique Hôpitaux de Paris, France; Institute of Neurology (W.M.M.S.), Konolfingen; Department of Neurology (W.M.M.S.), University Hospital Bern and University of Bern, Switzerland; Medtronic (L.T.), Minneapolis, MN; Institute of Clinical Neuroscience & Medical Psychology and Department of Neurology (A.D., L.W.), Medical Faculty, Heinrich-Heine-University Düsseldorf, Germany; Movement Disorder Unit, Neurology (P.K.), CHU Grenoble Alpes; Grenoble Institut des Neurosciences (P.K., V.F., A. Kistner), University Grenoble Alpes; Inserm U1216 (P.K., V.F., A. Kistner), Grenoble, France; Department of Clinical Neurosciences (Neurology) (P.K.), Faculty of Medicine, University of Geneva, Switzerland; Coordinating Center for clinical trials of the Philipps University of Marburg (J.R., C.S.-B.); Neurochirurgische Klinik im Neurozentrum (A.F., L.P., S.P., J. Volkmann, K.K., G.D.),Christian-Albrechts-Universität Kiel; Neurologische Klinik und Poliklinik (J. Volkmann), Universitätsklinikum Würzburg; Department of Neurology (H.S.D., M.T.B., G.R.F., L.T.), University Hospital Cologne; Research Centre Jülich (G.R.F.); Klinik für Neurologie (T.D.H., A. Kühn, A. Kupsch) and Klinik für Neurochirurgie (G.-H.S.), Campus Virchow, Charité-Universitätsmedizin Berlin; Praxis Kupsch (A. Kupsch), Berlin, Germany; Service de Neurochirurgie (E.S.) and Service de Neurologie (V.F.), Hôpital Michallon, Centre Hospitalo-Universitaire, Grenoble; Departments of Neurosurgery (P.P.C.), Neurology (F.O.-M., C.B.-C.), and Clinical Pharmacology (C.B.-C.), University Hospital of Toulouse; ToNIC (F.O.-M., C.B.-C.), Toulouse Neuroimaging Center, University of Toulouse, Inserm, UPS, France; Department of Neurosurgery (J. Vesper), Universitätsklinikum Düsseldorf, Germany; Departments of Neurosurgery (S.D.) and Neurology (D.M.), Rouen University Hospital and University of Rouen; INSERM U1239 (D.M.), Laboratory of Neuronal and Neuroendocrine Differentiation and Communication, Mont-Saint-Aignan; Service de Neurologie (P. Damier, P. Derkinderen), CHU Nantes, Hôpital Laënnec, France; Paracelsus-Elena-Klinik Kassel (F.S.-D., C.T.); Department of Neurosurgery (C.T.), University Medical Center Göttingen; Division of Functional and Restorative Neurosurgery and Centre for Integrative Neuroscience (A.G.), Tübingen; Abteilung für Neurologie (T.W.), Reha-Zentrum Bad Gögging, Passauer Wolf; Department for Neurodegenerative Diseases and Hertie Institute for Clinical Brain Research (D.W.), University of Tübingen; Division of Stereotactic and Functional Neurosurgery (M.O.P.), University Medical Center Freiburg, Germany; Departments of Functional and Stereotactic Neurosurgery and Radiosurgery (J.-.M.R.) and Neurology (T.W.), Timone University Hospital, INSERM, Marseille; Institut des Sciences Cognitives Marc Jeannerod (S.T.), CNRS, UMR 5229, Université de Lyon; Centre Expert Parkinson (S.T.), Service de Neurologie C, Hôpital Neurologique Pierre Wertheimer, Hospices Civils de Lyon, Bron; Department of Neurosurgery (P.M.), University Hospital of Neurology and Neurosurgery, Hospices Civils de Lyon, Université de Lyon; Department of Neurology (J.-L.H.), INSERM-1402, Centre Hospitalier Universitaire de Poitiers, University of Poitiers, France; and Universitätsklinikum Giessen und Marburg (L.T.), Marburg Campus, Germany.""}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Kistner', 'Affiliation': ""From the Département de Neurologie (W.M.M.S., A.H., T.D.H., F.P., Y.A., M.V.), Hôpital Pitié-Salpêtrière, Centre d'Investigation Clinique 1422, Institut du Cerveau et de la Moelle Epinière, Institut National de Santé et en Recherche Médicale, Assistance Publique Hôpitaux de Paris, France; Institute of Neurology (W.M.M.S.), Konolfingen; Department of Neurology (W.M.M.S.), University Hospital Bern and University of Bern, Switzerland; Medtronic (L.T.), Minneapolis, MN; Institute of Clinical Neuroscience & Medical Psychology and Department of Neurology (A.D., L.W.), Medical Faculty, Heinrich-Heine-University Düsseldorf, Germany; Movement Disorder Unit, Neurology (P.K.), CHU Grenoble Alpes; Grenoble Institut des Neurosciences (P.K., V.F., A. Kistner), University Grenoble Alpes; Inserm U1216 (P.K., V.F., A. Kistner), Grenoble, France; Department of Clinical Neurosciences (Neurology) (P.K.), Faculty of Medicine, University of Geneva, Switzerland; Coordinating Center for clinical trials of the Philipps University of Marburg (J.R., C.S.-B.); Neurochirurgische Klinik im Neurozentrum (A.F., L.P., S.P., J. Volkmann, K.K., G.D.),Christian-Albrechts-Universität Kiel; Neurologische Klinik und Poliklinik (J. Volkmann), Universitätsklinikum Würzburg; Department of Neurology (H.S.D., M.T.B., G.R.F., L.T.), University Hospital Cologne; Research Centre Jülich (G.R.F.); Klinik für Neurologie (T.D.H., A. Kühn, A. Kupsch) and Klinik für Neurochirurgie (G.-H.S.), Campus Virchow, Charité-Universitätsmedizin Berlin; Praxis Kupsch (A. Kupsch), Berlin, Germany; Service de Neurochirurgie (E.S.) and Service de Neurologie (V.F.), Hôpital Michallon, Centre Hospitalo-Universitaire, Grenoble; Departments of Neurosurgery (P.P.C.), Neurology (F.O.-M., C.B.-C.), and Clinical Pharmacology (C.B.-C.), University Hospital of Toulouse; ToNIC (F.O.-M., C.B.-C.), Toulouse Neuroimaging Center, University of Toulouse, Inserm, UPS, France; Department of Neurosurgery (J. Vesper), Universitätsklinikum Düsseldorf, Germany; Departments of Neurosurgery (S.D.) and Neurology (D.M.), Rouen University Hospital and University of Rouen; INSERM U1239 (D.M.), Laboratory of Neuronal and Neuroendocrine Differentiation and Communication, Mont-Saint-Aignan; Service de Neurologie (P. Damier, P. Derkinderen), CHU Nantes, Hôpital Laënnec, France; Paracelsus-Elena-Klinik Kassel (F.S.-D., C.T.); Department of Neurosurgery (C.T.), University Medical Center Göttingen; Division of Functional and Restorative Neurosurgery and Centre for Integrative Neuroscience (A.G.), Tübingen; Abteilung für Neurologie (T.W.), Reha-Zentrum Bad Gögging, Passauer Wolf; Department for Neurodegenerative Diseases and Hertie Institute for Clinical Brain Research (D.W.), University of Tübingen; Division of Stereotactic and Functional Neurosurgery (M.O.P.), University Medical Center Freiburg, Germany; Departments of Functional and Stereotactic Neurosurgery and Radiosurgery (J.-.M.R.) and Neurology (T.W.), Timone University Hospital, INSERM, Marseille; Institut des Sciences Cognitives Marc Jeannerod (S.T.), CNRS, UMR 5229, Université de Lyon; Centre Expert Parkinson (S.T.), Service de Neurologie C, Hôpital Neurologique Pierre Wertheimer, Hospices Civils de Lyon, Bron; Department of Neurosurgery (P.M.), University Hospital of Neurology and Neurosurgery, Hospices Civils de Lyon, Université de Lyon; Department of Neurology (J.-L.H.), INSERM-1402, Centre Hospitalier Universitaire de Poitiers, University of Poitiers, France; and Universitätsklinikum Giessen und Marburg (L.T.), Marburg Campus, Germany.""}, {'ForeName': 'P Patrick', 'Initials': 'PP', 'LastName': 'Chaynes', 'Affiliation': ""From the Département de Neurologie (W.M.M.S., A.H., T.D.H., F.P., Y.A., M.V.), Hôpital Pitié-Salpêtrière, Centre d'Investigation Clinique 1422, Institut du Cerveau et de la Moelle Epinière, Institut National de Santé et en Recherche Médicale, Assistance Publique Hôpitaux de Paris, France; Institute of Neurology (W.M.M.S.), Konolfingen; Department of Neurology (W.M.M.S.), University Hospital Bern and University of Bern, Switzerland; Medtronic (L.T.), Minneapolis, MN; Institute of Clinical Neuroscience & Medical Psychology and Department of Neurology (A.D., L.W.), Medical Faculty, Heinrich-Heine-University Düsseldorf, Germany; Movement Disorder Unit, Neurology (P.K.), CHU Grenoble Alpes; Grenoble Institut des Neurosciences (P.K., V.F., A. Kistner), University Grenoble Alpes; Inserm U1216 (P.K., V.F., A. Kistner), Grenoble, France; Department of Clinical Neurosciences (Neurology) (P.K.), Faculty of Medicine, University of Geneva, Switzerland; Coordinating Center for clinical trials of the Philipps University of Marburg (J.R., C.S.-B.); Neurochirurgische Klinik im Neurozentrum (A.F., L.P., S.P., J. Volkmann, K.K., G.D.),Christian-Albrechts-Universität Kiel; Neurologische Klinik und Poliklinik (J. Volkmann), Universitätsklinikum Würzburg; Department of Neurology (H.S.D., M.T.B., G.R.F., L.T.), University Hospital Cologne; Research Centre Jülich (G.R.F.); Klinik für Neurologie (T.D.H., A. Kühn, A. Kupsch) and Klinik für Neurochirurgie (G.-H.S.), Campus Virchow, Charité-Universitätsmedizin Berlin; Praxis Kupsch (A. Kupsch), Berlin, Germany; Service de Neurochirurgie (E.S.) and Service de Neurologie (V.F.), Hôpital Michallon, Centre Hospitalo-Universitaire, Grenoble; Departments of Neurosurgery (P.P.C.), Neurology (F.O.-M., C.B.-C.), and Clinical Pharmacology (C.B.-C.), University Hospital of Toulouse; ToNIC (F.O.-M., C.B.-C.), Toulouse Neuroimaging Center, University of Toulouse, Inserm, UPS, France; Department of Neurosurgery (J. Vesper), Universitätsklinikum Düsseldorf, Germany; Departments of Neurosurgery (S.D.) and Neurology (D.M.), Rouen University Hospital and University of Rouen; INSERM U1239 (D.M.), Laboratory of Neuronal and Neuroendocrine Differentiation and Communication, Mont-Saint-Aignan; Service de Neurologie (P. Damier, P. Derkinderen), CHU Nantes, Hôpital Laënnec, France; Paracelsus-Elena-Klinik Kassel (F.S.-D., C.T.); Department of Neurosurgery (C.T.), University Medical Center Göttingen; Division of Functional and Restorative Neurosurgery and Centre for Integrative Neuroscience (A.G.), Tübingen; Abteilung für Neurologie (T.W.), Reha-Zentrum Bad Gögging, Passauer Wolf; Department for Neurodegenerative Diseases and Hertie Institute for Clinical Brain Research (D.W.), University of Tübingen; Division of Stereotactic and Functional Neurosurgery (M.O.P.), University Medical Center Freiburg, Germany; Departments of Functional and Stereotactic Neurosurgery and Radiosurgery (J.-.M.R.) and Neurology (T.W.), Timone University Hospital, INSERM, Marseille; Institut des Sciences Cognitives Marc Jeannerod (S.T.), CNRS, UMR 5229, Université de Lyon; Centre Expert Parkinson (S.T.), Service de Neurologie C, Hôpital Neurologique Pierre Wertheimer, Hospices Civils de Lyon, Bron; Department of Neurosurgery (P.M.), University Hospital of Neurology and Neurosurgery, Hospices Civils de Lyon, Université de Lyon; Department of Neurology (J.-L.H.), INSERM-1402, Centre Hospitalier Universitaire de Poitiers, University of Poitiers, France; and Universitätsklinikum Giessen und Marburg (L.T.), Marburg Campus, Germany.""}, {'ForeName': 'Fabienne', 'Initials': 'F', 'LastName': 'Ory-Magne', 'Affiliation': ""From the Département de Neurologie (W.M.M.S., A.H., T.D.H., F.P., Y.A., M.V.), Hôpital Pitié-Salpêtrière, Centre d'Investigation Clinique 1422, Institut du Cerveau et de la Moelle Epinière, Institut National de Santé et en Recherche Médicale, Assistance Publique Hôpitaux de Paris, France; Institute of Neurology (W.M.M.S.), Konolfingen; Department of Neurology (W.M.M.S.), University Hospital Bern and University of Bern, Switzerland; Medtronic (L.T.), Minneapolis, MN; Institute of Clinical Neuroscience & Medical Psychology and Department of Neurology (A.D., L.W.), Medical Faculty, Heinrich-Heine-University Düsseldorf, Germany; Movement Disorder Unit, Neurology (P.K.), CHU Grenoble Alpes; Grenoble Institut des Neurosciences (P.K., V.F., A. Kistner), University Grenoble Alpes; Inserm U1216 (P.K., V.F., A. Kistner), Grenoble, France; Department of Clinical Neurosciences (Neurology) (P.K.), Faculty of Medicine, University of Geneva, Switzerland; Coordinating Center for clinical trials of the Philipps University of Marburg (J.R., C.S.-B.); Neurochirurgische Klinik im Neurozentrum (A.F., L.P., S.P., J. Volkmann, K.K., G.D.),Christian-Albrechts-Universität Kiel; Neurologische Klinik und Poliklinik (J. Volkmann), Universitätsklinikum Würzburg; Department of Neurology (H.S.D., M.T.B., G.R.F., L.T.), University Hospital Cologne; Research Centre Jülich (G.R.F.); Klinik für Neurologie (T.D.H., A. Kühn, A. Kupsch) and Klinik für Neurochirurgie (G.-H.S.), Campus Virchow, Charité-Universitätsmedizin Berlin; Praxis Kupsch (A. Kupsch), Berlin, Germany; Service de Neurochirurgie (E.S.) and Service de Neurologie (V.F.), Hôpital Michallon, Centre Hospitalo-Universitaire, Grenoble; Departments of Neurosurgery (P.P.C.), Neurology (F.O.-M., C.B.-C.), and Clinical Pharmacology (C.B.-C.), University Hospital of Toulouse; ToNIC (F.O.-M., C.B.-C.), Toulouse Neuroimaging Center, University of Toulouse, Inserm, UPS, France; Department of Neurosurgery (J. Vesper), Universitätsklinikum Düsseldorf, Germany; Departments of Neurosurgery (S.D.) and Neurology (D.M.), Rouen University Hospital and University of Rouen; INSERM U1239 (D.M.), Laboratory of Neuronal and Neuroendocrine Differentiation and Communication, Mont-Saint-Aignan; Service de Neurologie (P. Damier, P. Derkinderen), CHU Nantes, Hôpital Laënnec, France; Paracelsus-Elena-Klinik Kassel (F.S.-D., C.T.); Department of Neurosurgery (C.T.), University Medical Center Göttingen; Division of Functional and Restorative Neurosurgery and Centre for Integrative Neuroscience (A.G.), Tübingen; Abteilung für Neurologie (T.W.), Reha-Zentrum Bad Gögging, Passauer Wolf; Department for Neurodegenerative Diseases and Hertie Institute for Clinical Brain Research (D.W.), University of Tübingen; Division of Stereotactic and Functional Neurosurgery (M.O.P.), University Medical Center Freiburg, Germany; Departments of Functional and Stereotactic Neurosurgery and Radiosurgery (J.-.M.R.) and Neurology (T.W.), Timone University Hospital, INSERM, Marseille; Institut des Sciences Cognitives Marc Jeannerod (S.T.), CNRS, UMR 5229, Université de Lyon; Centre Expert Parkinson (S.T.), Service de Neurologie C, Hôpital Neurologique Pierre Wertheimer, Hospices Civils de Lyon, Bron; Department of Neurosurgery (P.M.), University Hospital of Neurology and Neurosurgery, Hospices Civils de Lyon, Université de Lyon; Department of Neurology (J.-L.H.), INSERM-1402, Centre Hospitalier Universitaire de Poitiers, University of Poitiers, France; and Universitätsklinikum Giessen und Marburg (L.T.), Marburg Campus, Germany.""}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Brefel-Courbon', 'Affiliation': ""From the Département de Neurologie (W.M.M.S., A.H., T.D.H., F.P., Y.A., M.V.), Hôpital Pitié-Salpêtrière, Centre d'Investigation Clinique 1422, Institut du Cerveau et de la Moelle Epinière, Institut National de Santé et en Recherche Médicale, Assistance Publique Hôpitaux de Paris, France; Institute of Neurology (W.M.M.S.), Konolfingen; Department of Neurology (W.M.M.S.), University Hospital Bern and University of Bern, Switzerland; Medtronic (L.T.), Minneapolis, MN; Institute of Clinical Neuroscience & Medical Psychology and Department of Neurology (A.D., L.W.), Medical Faculty, Heinrich-Heine-University Düsseldorf, Germany; Movement Disorder Unit, Neurology (P.K.), CHU Grenoble Alpes; Grenoble Institut des Neurosciences (P.K., V.F., A. Kistner), University Grenoble Alpes; Inserm U1216 (P.K., V.F., A. Kistner), Grenoble, France; Department of Clinical Neurosciences (Neurology) (P.K.), Faculty of Medicine, University of Geneva, Switzerland; Coordinating Center for clinical trials of the Philipps University of Marburg (J.R., C.S.-B.); Neurochirurgische Klinik im Neurozentrum (A.F., L.P., S.P., J. Volkmann, K.K., G.D.),Christian-Albrechts-Universität Kiel; Neurologische Klinik und Poliklinik (J. Volkmann), Universitätsklinikum Würzburg; Department of Neurology (H.S.D., M.T.B., G.R.F., L.T.), University Hospital Cologne; Research Centre Jülich (G.R.F.); Klinik für Neurologie (T.D.H., A. Kühn, A. Kupsch) and Klinik für Neurochirurgie (G.-H.S.), Campus Virchow, Charité-Universitätsmedizin Berlin; Praxis Kupsch (A. Kupsch), Berlin, Germany; Service de Neurochirurgie (E.S.) and Service de Neurologie (V.F.), Hôpital Michallon, Centre Hospitalo-Universitaire, Grenoble; Departments of Neurosurgery (P.P.C.), Neurology (F.O.-M., C.B.-C.), and Clinical Pharmacology (C.B.-C.), University Hospital of Toulouse; ToNIC (F.O.-M., C.B.-C.), Toulouse Neuroimaging Center, University of Toulouse, Inserm, UPS, France; Department of Neurosurgery (J. Vesper), Universitätsklinikum Düsseldorf, Germany; Departments of Neurosurgery (S.D.) and Neurology (D.M.), Rouen University Hospital and University of Rouen; INSERM U1239 (D.M.), Laboratory of Neuronal and Neuroendocrine Differentiation and Communication, Mont-Saint-Aignan; Service de Neurologie (P. Damier, P. Derkinderen), CHU Nantes, Hôpital Laënnec, France; Paracelsus-Elena-Klinik Kassel (F.S.-D., C.T.); Department of Neurosurgery (C.T.), University Medical Center Göttingen; Division of Functional and Restorative Neurosurgery and Centre for Integrative Neuroscience (A.G.), Tübingen; Abteilung für Neurologie (T.W.), Reha-Zentrum Bad Gögging, Passauer Wolf; Department for Neurodegenerative Diseases and Hertie Institute for Clinical Brain Research (D.W.), University of Tübingen; Division of Stereotactic and Functional Neurosurgery (M.O.P.), University Medical Center Freiburg, Germany; Departments of Functional and Stereotactic Neurosurgery and Radiosurgery (J.-.M.R.) and Neurology (T.W.), Timone University Hospital, INSERM, Marseille; Institut des Sciences Cognitives Marc Jeannerod (S.T.), CNRS, UMR 5229, Université de Lyon; Centre Expert Parkinson (S.T.), Service de Neurologie C, Hôpital Neurologique Pierre Wertheimer, Hospices Civils de Lyon, Bron; Department of Neurosurgery (P.M.), University Hospital of Neurology and Neurosurgery, Hospices Civils de Lyon, Université de Lyon; Department of Neurology (J.-L.H.), INSERM-1402, Centre Hospitalier Universitaire de Poitiers, University of Poitiers, France; and Universitätsklinikum Giessen und Marburg (L.T.), Marburg Campus, Germany.""}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Vesper', 'Affiliation': ""From the Département de Neurologie (W.M.M.S., A.H., T.D.H., F.P., Y.A., M.V.), Hôpital Pitié-Salpêtrière, Centre d'Investigation Clinique 1422, Institut du Cerveau et de la Moelle Epinière, Institut National de Santé et en Recherche Médicale, Assistance Publique Hôpitaux de Paris, France; Institute of Neurology (W.M.M.S.), Konolfingen; Department of Neurology (W.M.M.S.), University Hospital Bern and University of Bern, Switzerland; Medtronic (L.T.), Minneapolis, MN; Institute of Clinical Neuroscience & Medical Psychology and Department of Neurology (A.D., L.W.), Medical Faculty, Heinrich-Heine-University Düsseldorf, Germany; Movement Disorder Unit, Neurology (P.K.), CHU Grenoble Alpes; Grenoble Institut des Neurosciences (P.K., V.F., A. Kistner), University Grenoble Alpes; Inserm U1216 (P.K., V.F., A. Kistner), Grenoble, France; Department of Clinical Neurosciences (Neurology) (P.K.), Faculty of Medicine, University of Geneva, Switzerland; Coordinating Center for clinical trials of the Philipps University of Marburg (J.R., C.S.-B.); Neurochirurgische Klinik im Neurozentrum (A.F., L.P., S.P., J. Volkmann, K.K., G.D.),Christian-Albrechts-Universität Kiel; Neurologische Klinik und Poliklinik (J. Volkmann), Universitätsklinikum Würzburg; Department of Neurology (H.S.D., M.T.B., G.R.F., L.T.), University Hospital Cologne; Research Centre Jülich (G.R.F.); Klinik für Neurologie (T.D.H., A. Kühn, A. Kupsch) and Klinik für Neurochirurgie (G.-H.S.), Campus Virchow, Charité-Universitätsmedizin Berlin; Praxis Kupsch (A. Kupsch), Berlin, Germany; Service de Neurochirurgie (E.S.) and Service de Neurologie (V.F.), Hôpital Michallon, Centre Hospitalo-Universitaire, Grenoble; Departments of Neurosurgery (P.P.C.), Neurology (F.O.-M., C.B.-C.), and Clinical Pharmacology (C.B.-C.), University Hospital of Toulouse; ToNIC (F.O.-M., C.B.-C.), Toulouse Neuroimaging Center, University of Toulouse, Inserm, UPS, France; Department of Neurosurgery (J. Vesper), Universitätsklinikum Düsseldorf, Germany; Departments of Neurosurgery (S.D.) and Neurology (D.M.), Rouen University Hospital and University of Rouen; INSERM U1239 (D.M.), Laboratory of Neuronal and Neuroendocrine Differentiation and Communication, Mont-Saint-Aignan; Service de Neurologie (P. Damier, P. Derkinderen), CHU Nantes, Hôpital Laënnec, France; Paracelsus-Elena-Klinik Kassel (F.S.-D., C.T.); Department of Neurosurgery (C.T.), University Medical Center Göttingen; Division of Functional and Restorative Neurosurgery and Centre for Integrative Neuroscience (A.G.), Tübingen; Abteilung für Neurologie (T.W.), Reha-Zentrum Bad Gögging, Passauer Wolf; Department for Neurodegenerative Diseases and Hertie Institute for Clinical Brain Research (D.W.), University of Tübingen; Division of Stereotactic and Functional Neurosurgery (M.O.P.), University Medical Center Freiburg, Germany; Departments of Functional and Stereotactic Neurosurgery and Radiosurgery (J.-.M.R.) and Neurology (T.W.), Timone University Hospital, INSERM, Marseille; Institut des Sciences Cognitives Marc Jeannerod (S.T.), CNRS, UMR 5229, Université de Lyon; Centre Expert Parkinson (S.T.), Service de Neurologie C, Hôpital Neurologique Pierre Wertheimer, Hospices Civils de Lyon, Bron; Department of Neurosurgery (P.M.), University Hospital of Neurology and Neurosurgery, Hospices Civils de Lyon, Université de Lyon; Department of Neurology (J.-L.H.), INSERM-1402, Centre Hospitalier Universitaire de Poitiers, University of Poitiers, France; and Universitätsklinikum Giessen und Marburg (L.T.), Marburg Campus, Germany.""}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Wojtecki', 'Affiliation': ""From the Département de Neurologie (W.M.M.S., A.H., T.D.H., F.P., Y.A., M.V.), Hôpital Pitié-Salpêtrière, Centre d'Investigation Clinique 1422, Institut du Cerveau et de la Moelle Epinière, Institut National de Santé et en Recherche Médicale, Assistance Publique Hôpitaux de Paris, France; Institute of Neurology (W.M.M.S.), Konolfingen; Department of Neurology (W.M.M.S.), University Hospital Bern and University of Bern, Switzerland; Medtronic (L.T.), Minneapolis, MN; Institute of Clinical Neuroscience & Medical Psychology and Department of Neurology (A.D., L.W.), Medical Faculty, Heinrich-Heine-University Düsseldorf, Germany; Movement Disorder Unit, Neurology (P.K.), CHU Grenoble Alpes; Grenoble Institut des Neurosciences (P.K., V.F., A. Kistner), University Grenoble Alpes; Inserm U1216 (P.K., V.F., A. Kistner), Grenoble, France; Department of Clinical Neurosciences (Neurology) (P.K.), Faculty of Medicine, University of Geneva, Switzerland; Coordinating Center for clinical trials of the Philipps University of Marburg (J.R., C.S.-B.); Neurochirurgische Klinik im Neurozentrum (A.F., L.P., S.P., J. Volkmann, K.K., G.D.),Christian-Albrechts-Universität Kiel; Neurologische Klinik und Poliklinik (J. Volkmann), Universitätsklinikum Würzburg; Department of Neurology (H.S.D., M.T.B., G.R.F., L.T.), University Hospital Cologne; Research Centre Jülich (G.R.F.); Klinik für Neurologie (T.D.H., A. Kühn, A. Kupsch) and Klinik für Neurochirurgie (G.-H.S.), Campus Virchow, Charité-Universitätsmedizin Berlin; Praxis Kupsch (A. Kupsch), Berlin, Germany; Service de Neurochirurgie (E.S.) and Service de Neurologie (V.F.), Hôpital Michallon, Centre Hospitalo-Universitaire, Grenoble; Departments of Neurosurgery (P.P.C.), Neurology (F.O.-M., C.B.-C.), and Clinical Pharmacology (C.B.-C.), University Hospital of Toulouse; ToNIC (F.O.-M., C.B.-C.), Toulouse Neuroimaging Center, University of Toulouse, Inserm, UPS, France; Department of Neurosurgery (J. Vesper), Universitätsklinikum Düsseldorf, Germany; Departments of Neurosurgery (S.D.) and Neurology (D.M.), Rouen University Hospital and University of Rouen; INSERM U1239 (D.M.), Laboratory of Neuronal and Neuroendocrine Differentiation and Communication, Mont-Saint-Aignan; Service de Neurologie (P. Damier, P. Derkinderen), CHU Nantes, Hôpital Laënnec, France; Paracelsus-Elena-Klinik Kassel (F.S.-D., C.T.); Department of Neurosurgery (C.T.), University Medical Center Göttingen; Division of Functional and Restorative Neurosurgery and Centre for Integrative Neuroscience (A.G.), Tübingen; Abteilung für Neurologie (T.W.), Reha-Zentrum Bad Gögging, Passauer Wolf; Department for Neurodegenerative Diseases and Hertie Institute for Clinical Brain Research (D.W.), University of Tübingen; Division of Stereotactic and Functional Neurosurgery (M.O.P.), University Medical Center Freiburg, Germany; Departments of Functional and Stereotactic Neurosurgery and Radiosurgery (J.-.M.R.) and Neurology (T.W.), Timone University Hospital, INSERM, Marseille; Institut des Sciences Cognitives Marc Jeannerod (S.T.), CNRS, UMR 5229, Université de Lyon; Centre Expert Parkinson (S.T.), Service de Neurologie C, Hôpital Neurologique Pierre Wertheimer, Hospices Civils de Lyon, Bron; Department of Neurosurgery (P.M.), University Hospital of Neurology and Neurosurgery, Hospices Civils de Lyon, Université de Lyon; Department of Neurology (J.-L.H.), INSERM-1402, Centre Hospitalier Universitaire de Poitiers, University of Poitiers, France; and Universitätsklinikum Giessen und Marburg (L.T.), Marburg Campus, Germany.""}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Derrey', 'Affiliation': ""From the Département de Neurologie (W.M.M.S., A.H., T.D.H., F.P., Y.A., M.V.), Hôpital Pitié-Salpêtrière, Centre d'Investigation Clinique 1422, Institut du Cerveau et de la Moelle Epinière, Institut National de Santé et en Recherche Médicale, Assistance Publique Hôpitaux de Paris, France; Institute of Neurology (W.M.M.S.), Konolfingen; Department of Neurology (W.M.M.S.), University Hospital Bern and University of Bern, Switzerland; Medtronic (L.T.), Minneapolis, MN; Institute of Clinical Neuroscience & Medical Psychology and Department of Neurology (A.D., L.W.), Medical Faculty, Heinrich-Heine-University Düsseldorf, Germany; Movement Disorder Unit, Neurology (P.K.), CHU Grenoble Alpes; Grenoble Institut des Neurosciences (P.K., V.F., A. Kistner), University Grenoble Alpes; Inserm U1216 (P.K., V.F., A. Kistner), Grenoble, France; Department of Clinical Neurosciences (Neurology) (P.K.), Faculty of Medicine, University of Geneva, Switzerland; Coordinating Center for clinical trials of the Philipps University of Marburg (J.R., C.S.-B.); Neurochirurgische Klinik im Neurozentrum (A.F., L.P., S.P., J. Volkmann, K.K., G.D.),Christian-Albrechts-Universität Kiel; Neurologische Klinik und Poliklinik (J. Volkmann), Universitätsklinikum Würzburg; Department of Neurology (H.S.D., M.T.B., G.R.F., L.T.), University Hospital Cologne; Research Centre Jülich (G.R.F.); Klinik für Neurologie (T.D.H., A. Kühn, A. Kupsch) and Klinik für Neurochirurgie (G.-H.S.), Campus Virchow, Charité-Universitätsmedizin Berlin; Praxis Kupsch (A. Kupsch), Berlin, Germany; Service de Neurochirurgie (E.S.) and Service de Neurologie (V.F.), Hôpital Michallon, Centre Hospitalo-Universitaire, Grenoble; Departments of Neurosurgery (P.P.C.), Neurology (F.O.-M., C.B.-C.), and Clinical Pharmacology (C.B.-C.), University Hospital of Toulouse; ToNIC (F.O.-M., C.B.-C.), Toulouse Neuroimaging Center, University of Toulouse, Inserm, UPS, France; Department of Neurosurgery (J. Vesper), Universitätsklinikum Düsseldorf, Germany; Departments of Neurosurgery (S.D.) and Neurology (D.M.), Rouen University Hospital and University of Rouen; INSERM U1239 (D.M.), Laboratory of Neuronal and Neuroendocrine Differentiation and Communication, Mont-Saint-Aignan; Service de Neurologie (P. Damier, P. Derkinderen), CHU Nantes, Hôpital Laënnec, France; Paracelsus-Elena-Klinik Kassel (F.S.-D., C.T.); Department of Neurosurgery (C.T.), University Medical Center Göttingen; Division of Functional and Restorative Neurosurgery and Centre for Integrative Neuroscience (A.G.), Tübingen; Abteilung für Neurologie (T.W.), Reha-Zentrum Bad Gögging, Passauer Wolf; Department for Neurodegenerative Diseases and Hertie Institute for Clinical Brain Research (D.W.), University of Tübingen; Division of Stereotactic and Functional Neurosurgery (M.O.P.), University Medical Center Freiburg, Germany; Departments of Functional and Stereotactic Neurosurgery and Radiosurgery (J.-.M.R.) and Neurology (T.W.), Timone University Hospital, INSERM, Marseille; Institut des Sciences Cognitives Marc Jeannerod (S.T.), CNRS, UMR 5229, Université de Lyon; Centre Expert Parkinson (S.T.), Service de Neurologie C, Hôpital Neurologique Pierre Wertheimer, Hospices Civils de Lyon, Bron; Department of Neurosurgery (P.M.), University Hospital of Neurology and Neurosurgery, Hospices Civils de Lyon, Université de Lyon; Department of Neurology (J.-L.H.), INSERM-1402, Centre Hospitalier Universitaire de Poitiers, University of Poitiers, France; and Universitätsklinikum Giessen und Marburg (L.T.), Marburg Campus, Germany.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Maltête', 'Affiliation': ""From the Département de Neurologie (W.M.M.S., A.H., T.D.H., F.P., Y.A., M.V.), Hôpital Pitié-Salpêtrière, Centre d'Investigation Clinique 1422, Institut du Cerveau et de la Moelle Epinière, Institut National de Santé et en Recherche Médicale, Assistance Publique Hôpitaux de Paris, France; Institute of Neurology (W.M.M.S.), Konolfingen; Department of Neurology (W.M.M.S.), University Hospital Bern and University of Bern, Switzerland; Medtronic (L.T.), Minneapolis, MN; Institute of Clinical Neuroscience & Medical Psychology and Department of Neurology (A.D., L.W.), Medical Faculty, Heinrich-Heine-University Düsseldorf, Germany; Movement Disorder Unit, Neurology (P.K.), CHU Grenoble Alpes; Grenoble Institut des Neurosciences (P.K., V.F., A. Kistner), University Grenoble Alpes; Inserm U1216 (P.K., V.F., A. Kistner), Grenoble, France; Department of Clinical Neurosciences (Neurology) (P.K.), Faculty of Medicine, University of Geneva, Switzerland; Coordinating Center for clinical trials of the Philipps University of Marburg (J.R., C.S.-B.); Neurochirurgische Klinik im Neurozentrum (A.F., L.P., S.P., J. Volkmann, K.K., G.D.),Christian-Albrechts-Universität Kiel; Neurologische Klinik und Poliklinik (J. Volkmann), Universitätsklinikum Würzburg; Department of Neurology (H.S.D., M.T.B., G.R.F., L.T.), University Hospital Cologne; Research Centre Jülich (G.R.F.); Klinik für Neurologie (T.D.H., A. Kühn, A. Kupsch) and Klinik für Neurochirurgie (G.-H.S.), Campus Virchow, Charité-Universitätsmedizin Berlin; Praxis Kupsch (A. Kupsch), Berlin, Germany; Service de Neurochirurgie (E.S.) and Service de Neurologie (V.F.), Hôpital Michallon, Centre Hospitalo-Universitaire, Grenoble; Departments of Neurosurgery (P.P.C.), Neurology (F.O.-M., C.B.-C.), and Clinical Pharmacology (C.B.-C.), University Hospital of Toulouse; ToNIC (F.O.-M., C.B.-C.), Toulouse Neuroimaging Center, University of Toulouse, Inserm, UPS, France; Department of Neurosurgery (J. Vesper), Universitätsklinikum Düsseldorf, Germany; Departments of Neurosurgery (S.D.) and Neurology (D.M.), Rouen University Hospital and University of Rouen; INSERM U1239 (D.M.), Laboratory of Neuronal and Neuroendocrine Differentiation and Communication, Mont-Saint-Aignan; Service de Neurologie (P. Damier, P. Derkinderen), CHU Nantes, Hôpital Laënnec, France; Paracelsus-Elena-Klinik Kassel (F.S.-D., C.T.); Department of Neurosurgery (C.T.), University Medical Center Göttingen; Division of Functional and Restorative Neurosurgery and Centre for Integrative Neuroscience (A.G.), Tübingen; Abteilung für Neurologie (T.W.), Reha-Zentrum Bad Gögging, Passauer Wolf; Department for Neurodegenerative Diseases and Hertie Institute for Clinical Brain Research (D.W.), University of Tübingen; Division of Stereotactic and Functional Neurosurgery (M.O.P.), University Medical Center Freiburg, Germany; Departments of Functional and Stereotactic Neurosurgery and Radiosurgery (J.-.M.R.) and Neurology (T.W.), Timone University Hospital, INSERM, Marseille; Institut des Sciences Cognitives Marc Jeannerod (S.T.), CNRS, UMR 5229, Université de Lyon; Centre Expert Parkinson (S.T.), Service de Neurologie C, Hôpital Neurologique Pierre Wertheimer, Hospices Civils de Lyon, Bron; Department of Neurosurgery (P.M.), University Hospital of Neurology and Neurosurgery, Hospices Civils de Lyon, Université de Lyon; Department of Neurology (J.-L.H.), INSERM-1402, Centre Hospitalier Universitaire de Poitiers, University of Poitiers, France; and Universitätsklinikum Giessen und Marburg (L.T.), Marburg Campus, Germany.""}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Damier', 'Affiliation': ""From the Département de Neurologie (W.M.M.S., A.H., T.D.H., F.P., Y.A., M.V.), Hôpital Pitié-Salpêtrière, Centre d'Investigation Clinique 1422, Institut du Cerveau et de la Moelle Epinière, Institut National de Santé et en Recherche Médicale, Assistance Publique Hôpitaux de Paris, France; Institute of Neurology (W.M.M.S.), Konolfingen; Department of Neurology (W.M.M.S.), University Hospital Bern and University of Bern, Switzerland; Medtronic (L.T.), Minneapolis, MN; Institute of Clinical Neuroscience & Medical Psychology and Department of Neurology (A.D., L.W.), Medical Faculty, Heinrich-Heine-University Düsseldorf, Germany; Movement Disorder Unit, Neurology (P.K.), CHU Grenoble Alpes; Grenoble Institut des Neurosciences (P.K., V.F., A. Kistner), University Grenoble Alpes; Inserm U1216 (P.K., V.F., A. Kistner), Grenoble, France; Department of Clinical Neurosciences (Neurology) (P.K.), Faculty of Medicine, University of Geneva, Switzerland; Coordinating Center for clinical trials of the Philipps University of Marburg (J.R., C.S.-B.); Neurochirurgische Klinik im Neurozentrum (A.F., L.P., S.P., J. Volkmann, K.K., G.D.),Christian-Albrechts-Universität Kiel; Neurologische Klinik und Poliklinik (J. Volkmann), Universitätsklinikum Würzburg; Department of Neurology (H.S.D., M.T.B., G.R.F., L.T.), University Hospital Cologne; Research Centre Jülich (G.R.F.); Klinik für Neurologie (T.D.H., A. Kühn, A. Kupsch) and Klinik für Neurochirurgie (G.-H.S.), Campus Virchow, Charité-Universitätsmedizin Berlin; Praxis Kupsch (A. Kupsch), Berlin, Germany; Service de Neurochirurgie (E.S.) and Service de Neurologie (V.F.), Hôpital Michallon, Centre Hospitalo-Universitaire, Grenoble; Departments of Neurosurgery (P.P.C.), Neurology (F.O.-M., C.B.-C.), and Clinical Pharmacology (C.B.-C.), University Hospital of Toulouse; ToNIC (F.O.-M., C.B.-C.), Toulouse Neuroimaging Center, University of Toulouse, Inserm, UPS, France; Department of Neurosurgery (J. Vesper), Universitätsklinikum Düsseldorf, Germany; Departments of Neurosurgery (S.D.) and Neurology (D.M.), Rouen University Hospital and University of Rouen; INSERM U1239 (D.M.), Laboratory of Neuronal and Neuroendocrine Differentiation and Communication, Mont-Saint-Aignan; Service de Neurologie (P. Damier, P. Derkinderen), CHU Nantes, Hôpital Laënnec, France; Paracelsus-Elena-Klinik Kassel (F.S.-D., C.T.); Department of Neurosurgery (C.T.), University Medical Center Göttingen; Division of Functional and Restorative Neurosurgery and Centre for Integrative Neuroscience (A.G.), Tübingen; Abteilung für Neurologie (T.W.), Reha-Zentrum Bad Gögging, Passauer Wolf; Department for Neurodegenerative Diseases and Hertie Institute for Clinical Brain Research (D.W.), University of Tübingen; Division of Stereotactic and Functional Neurosurgery (M.O.P.), University Medical Center Freiburg, Germany; Departments of Functional and Stereotactic Neurosurgery and Radiosurgery (J.-.M.R.) and Neurology (T.W.), Timone University Hospital, INSERM, Marseille; Institut des Sciences Cognitives Marc Jeannerod (S.T.), CNRS, UMR 5229, Université de Lyon; Centre Expert Parkinson (S.T.), Service de Neurologie C, Hôpital Neurologique Pierre Wertheimer, Hospices Civils de Lyon, Bron; Department of Neurosurgery (P.M.), University Hospital of Neurology and Neurosurgery, Hospices Civils de Lyon, Université de Lyon; Department of Neurology (J.-L.H.), INSERM-1402, Centre Hospitalier Universitaire de Poitiers, University of Poitiers, France; and Universitätsklinikum Giessen und Marburg (L.T.), Marburg Campus, Germany.""}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Derkinderen', 'Affiliation': ""From the Département de Neurologie (W.M.M.S., A.H., T.D.H., F.P., Y.A., M.V.), Hôpital Pitié-Salpêtrière, Centre d'Investigation Clinique 1422, Institut du Cerveau et de la Moelle Epinière, Institut National de Santé et en Recherche Médicale, Assistance Publique Hôpitaux de Paris, France; Institute of Neurology (W.M.M.S.), Konolfingen; Department of Neurology (W.M.M.S.), University Hospital Bern and University of Bern, Switzerland; Medtronic (L.T.), Minneapolis, MN; Institute of Clinical Neuroscience & Medical Psychology and Department of Neurology (A.D., L.W.), Medical Faculty, Heinrich-Heine-University Düsseldorf, Germany; Movement Disorder Unit, Neurology (P.K.), CHU Grenoble Alpes; Grenoble Institut des Neurosciences (P.K., V.F., A. Kistner), University Grenoble Alpes; Inserm U1216 (P.K., V.F., A. Kistner), Grenoble, France; Department of Clinical Neurosciences (Neurology) (P.K.), Faculty of Medicine, University of Geneva, Switzerland; Coordinating Center for clinical trials of the Philipps University of Marburg (J.R., C.S.-B.); Neurochirurgische Klinik im Neurozentrum (A.F., L.P., S.P., J. Volkmann, K.K., G.D.),Christian-Albrechts-Universität Kiel; Neurologische Klinik und Poliklinik (J. Volkmann), Universitätsklinikum Würzburg; Department of Neurology (H.S.D., M.T.B., G.R.F., L.T.), University Hospital Cologne; Research Centre Jülich (G.R.F.); Klinik für Neurologie (T.D.H., A. Kühn, A. Kupsch) and Klinik für Neurochirurgie (G.-H.S.), Campus Virchow, Charité-Universitätsmedizin Berlin; Praxis Kupsch (A. Kupsch), Berlin, Germany; Service de Neurochirurgie (E.S.) and Service de Neurologie (V.F.), Hôpital Michallon, Centre Hospitalo-Universitaire, Grenoble; Departments of Neurosurgery (P.P.C.), Neurology (F.O.-M., C.B.-C.), and Clinical Pharmacology (C.B.-C.), University Hospital of Toulouse; ToNIC (F.O.-M., C.B.-C.), Toulouse Neuroimaging Center, University of Toulouse, Inserm, UPS, France; Department of Neurosurgery (J. Vesper), Universitätsklinikum Düsseldorf, Germany; Departments of Neurosurgery (S.D.) and Neurology (D.M.), Rouen University Hospital and University of Rouen; INSERM U1239 (D.M.), Laboratory of Neuronal and Neuroendocrine Differentiation and Communication, Mont-Saint-Aignan; Service de Neurologie (P. Damier, P. Derkinderen), CHU Nantes, Hôpital Laënnec, France; Paracelsus-Elena-Klinik Kassel (F.S.-D., C.T.); Department of Neurosurgery (C.T.), University Medical Center Göttingen; Division of Functional and Restorative Neurosurgery and Centre for Integrative Neuroscience (A.G.), Tübingen; Abteilung für Neurologie (T.W.), Reha-Zentrum Bad Gögging, Passauer Wolf; Department for Neurodegenerative Diseases and Hertie Institute for Clinical Brain Research (D.W.), University of Tübingen; Division of Stereotactic and Functional Neurosurgery (M.O.P.), University Medical Center Freiburg, Germany; Departments of Functional and Stereotactic Neurosurgery and Radiosurgery (J.-.M.R.) and Neurology (T.W.), Timone University Hospital, INSERM, Marseille; Institut des Sciences Cognitives Marc Jeannerod (S.T.), CNRS, UMR 5229, Université de Lyon; Centre Expert Parkinson (S.T.), Service de Neurologie C, Hôpital Neurologique Pierre Wertheimer, Hospices Civils de Lyon, Bron; Department of Neurosurgery (P.M.), University Hospital of Neurology and Neurosurgery, Hospices Civils de Lyon, Université de Lyon; Department of Neurology (J.-L.H.), INSERM-1402, Centre Hospitalier Universitaire de Poitiers, University of Poitiers, France; and Universitätsklinikum Giessen und Marburg (L.T.), Marburg Campus, Germany.""}, {'ForeName': 'Friederike', 'Initials': 'F', 'LastName': 'Sixel-Döring', 'Affiliation': ""From the Département de Neurologie (W.M.M.S., A.H., T.D.H., F.P., Y.A., M.V.), Hôpital Pitié-Salpêtrière, Centre d'Investigation Clinique 1422, Institut du Cerveau et de la Moelle Epinière, Institut National de Santé et en Recherche Médicale, Assistance Publique Hôpitaux de Paris, France; Institute of Neurology (W.M.M.S.), Konolfingen; Department of Neurology (W.M.M.S.), University Hospital Bern and University of Bern, Switzerland; Medtronic (L.T.), Minneapolis, MN; Institute of Clinical Neuroscience & Medical Psychology and Department of Neurology (A.D., L.W.), Medical Faculty, Heinrich-Heine-University Düsseldorf, Germany; Movement Disorder Unit, Neurology (P.K.), CHU Grenoble Alpes; Grenoble Institut des Neurosciences (P.K., V.F., A. Kistner), University Grenoble Alpes; Inserm U1216 (P.K., V.F., A. Kistner), Grenoble, France; Department of Clinical Neurosciences (Neurology) (P.K.), Faculty of Medicine, University of Geneva, Switzerland; Coordinating Center for clinical trials of the Philipps University of Marburg (J.R., C.S.-B.); Neurochirurgische Klinik im Neurozentrum (A.F., L.P., S.P., J. Volkmann, K.K., G.D.),Christian-Albrechts-Universität Kiel; Neurologische Klinik und Poliklinik (J. Volkmann), Universitätsklinikum Würzburg; Department of Neurology (H.S.D., M.T.B., G.R.F., L.T.), University Hospital Cologne; Research Centre Jülich (G.R.F.); Klinik für Neurologie (T.D.H., A. Kühn, A. Kupsch) and Klinik für Neurochirurgie (G.-H.S.), Campus Virchow, Charité-Universitätsmedizin Berlin; Praxis Kupsch (A. Kupsch), Berlin, Germany; Service de Neurochirurgie (E.S.) and Service de Neurologie (V.F.), Hôpital Michallon, Centre Hospitalo-Universitaire, Grenoble; Departments of Neurosurgery (P.P.C.), Neurology (F.O.-M., C.B.-C.), and Clinical Pharmacology (C.B.-C.), University Hospital of Toulouse; ToNIC (F.O.-M., C.B.-C.), Toulouse Neuroimaging Center, University of Toulouse, Inserm, UPS, France; Department of Neurosurgery (J. Vesper), Universitätsklinikum Düsseldorf, Germany; Departments of Neurosurgery (S.D.) and Neurology (D.M.), Rouen University Hospital and University of Rouen; INSERM U1239 (D.M.), Laboratory of Neuronal and Neuroendocrine Differentiation and Communication, Mont-Saint-Aignan; Service de Neurologie (P. Damier, P. Derkinderen), CHU Nantes, Hôpital Laënnec, France; Paracelsus-Elena-Klinik Kassel (F.S.-D., C.T.); Department of Neurosurgery (C.T.), University Medical Center Göttingen; Division of Functional and Restorative Neurosurgery and Centre for Integrative Neuroscience (A.G.), Tübingen; Abteilung für Neurologie (T.W.), Reha-Zentrum Bad Gögging, Passauer Wolf; Department for Neurodegenerative Diseases and Hertie Institute for Clinical Brain Research (D.W.), University of Tübingen; Division of Stereotactic and Functional Neurosurgery (M.O.P.), University Medical Center Freiburg, Germany; Departments of Functional and Stereotactic Neurosurgery and Radiosurgery (J.-.M.R.) and Neurology (T.W.), Timone University Hospital, INSERM, Marseille; Institut des Sciences Cognitives Marc Jeannerod (S.T.), CNRS, UMR 5229, Université de Lyon; Centre Expert Parkinson (S.T.), Service de Neurologie C, Hôpital Neurologique Pierre Wertheimer, Hospices Civils de Lyon, Bron; Department of Neurosurgery (P.M.), University Hospital of Neurology and Neurosurgery, Hospices Civils de Lyon, Université de Lyon; Department of Neurology (J.-L.H.), INSERM-1402, Centre Hospitalier Universitaire de Poitiers, University of Poitiers, France; and Universitätsklinikum Giessen und Marburg (L.T.), Marburg Campus, Germany.""}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Trenkwalder', 'Affiliation': ""From the Département de Neurologie (W.M.M.S., A.H., T.D.H., F.P., Y.A., M.V.), Hôpital Pitié-Salpêtrière, Centre d'Investigation Clinique 1422, Institut du Cerveau et de la Moelle Epinière, Institut National de Santé et en Recherche Médicale, Assistance Publique Hôpitaux de Paris, France; Institute of Neurology (W.M.M.S.), Konolfingen; Department of Neurology (W.M.M.S.), University Hospital Bern and University of Bern, Switzerland; Medtronic (L.T.), Minneapolis, MN; Institute of Clinical Neuroscience & Medical Psychology and Department of Neurology (A.D., L.W.), Medical Faculty, Heinrich-Heine-University Düsseldorf, Germany; Movement Disorder Unit, Neurology (P.K.), CHU Grenoble Alpes; Grenoble Institut des Neurosciences (P.K., V.F., A. Kistner), University Grenoble Alpes; Inserm U1216 (P.K., V.F., A. Kistner), Grenoble, France; Department of Clinical Neurosciences (Neurology) (P.K.), Faculty of Medicine, University of Geneva, Switzerland; Coordinating Center for clinical trials of the Philipps University of Marburg (J.R., C.S.-B.); Neurochirurgische Klinik im Neurozentrum (A.F., L.P., S.P., J. Volkmann, K.K., G.D.),Christian-Albrechts-Universität Kiel; Neurologische Klinik und Poliklinik (J. Volkmann), Universitätsklinikum Würzburg; Department of Neurology (H.S.D., M.T.B., G.R.F., L.T.), University Hospital Cologne; Research Centre Jülich (G.R.F.); Klinik für Neurologie (T.D.H., A. Kühn, A. Kupsch) and Klinik für Neurochirurgie (G.-H.S.), Campus Virchow, Charité-Universitätsmedizin Berlin; Praxis Kupsch (A. Kupsch), Berlin, Germany; Service de Neurochirurgie (E.S.) and Service de Neurologie (V.F.), Hôpital Michallon, Centre Hospitalo-Universitaire, Grenoble; Departments of Neurosurgery (P.P.C.), Neurology (F.O.-M., C.B.-C.), and Clinical Pharmacology (C.B.-C.), University Hospital of Toulouse; ToNIC (F.O.-M., C.B.-C.), Toulouse Neuroimaging Center, University of Toulouse, Inserm, UPS, France; Department of Neurosurgery (J. Vesper), Universitätsklinikum Düsseldorf, Germany; Departments of Neurosurgery (S.D.) and Neurology (D.M.), Rouen University Hospital and University of Rouen; INSERM U1239 (D.M.), Laboratory of Neuronal and Neuroendocrine Differentiation and Communication, Mont-Saint-Aignan; Service de Neurologie (P. Damier, P. Derkinderen), CHU Nantes, Hôpital Laënnec, France; Paracelsus-Elena-Klinik Kassel (F.S.-D., C.T.); Department of Neurosurgery (C.T.), University Medical Center Göttingen; Division of Functional and Restorative Neurosurgery and Centre for Integrative Neuroscience (A.G.), Tübingen; Abteilung für Neurologie (T.W.), Reha-Zentrum Bad Gögging, Passauer Wolf; Department for Neurodegenerative Diseases and Hertie Institute for Clinical Brain Research (D.W.), University of Tübingen; Division of Stereotactic and Functional Neurosurgery (M.O.P.), University Medical Center Freiburg, Germany; Departments of Functional and Stereotactic Neurosurgery and Radiosurgery (J.-.M.R.) and Neurology (T.W.), Timone University Hospital, INSERM, Marseille; Institut des Sciences Cognitives Marc Jeannerod (S.T.), CNRS, UMR 5229, Université de Lyon; Centre Expert Parkinson (S.T.), Service de Neurologie C, Hôpital Neurologique Pierre Wertheimer, Hospices Civils de Lyon, Bron; Department of Neurosurgery (P.M.), University Hospital of Neurology and Neurosurgery, Hospices Civils de Lyon, Université de Lyon; Department of Neurology (J.-L.H.), INSERM-1402, Centre Hospitalier Universitaire de Poitiers, University of Poitiers, France; and Universitätsklinikum Giessen und Marburg (L.T.), Marburg Campus, Germany.""}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Gharabaghi', 'Affiliation': ""From the Département de Neurologie (W.M.M.S., A.H., T.D.H., F.P., Y.A., M.V.), Hôpital Pitié-Salpêtrière, Centre d'Investigation Clinique 1422, Institut du Cerveau et de la Moelle Epinière, Institut National de Santé et en Recherche Médicale, Assistance Publique Hôpitaux de Paris, France; Institute of Neurology (W.M.M.S.), Konolfingen; Department of Neurology (W.M.M.S.), University Hospital Bern and University of Bern, Switzerland; Medtronic (L.T.), Minneapolis, MN; Institute of Clinical Neuroscience & Medical Psychology and Department of Neurology (A.D., L.W.), Medical Faculty, Heinrich-Heine-University Düsseldorf, Germany; Movement Disorder Unit, Neurology (P.K.), CHU Grenoble Alpes; Grenoble Institut des Neurosciences (P.K., V.F., A. Kistner), University Grenoble Alpes; Inserm U1216 (P.K., V.F., A. Kistner), Grenoble, France; Department of Clinical Neurosciences (Neurology) (P.K.), Faculty of Medicine, University of Geneva, Switzerland; Coordinating Center for clinical trials of the Philipps University of Marburg (J.R., C.S.-B.); Neurochirurgische Klinik im Neurozentrum (A.F., L.P., S.P., J. Volkmann, K.K., G.D.),Christian-Albrechts-Universität Kiel; Neurologische Klinik und Poliklinik (J. Volkmann), Universitätsklinikum Würzburg; Department of Neurology (H.S.D., M.T.B., G.R.F., L.T.), University Hospital Cologne; Research Centre Jülich (G.R.F.); Klinik für Neurologie (T.D.H., A. Kühn, A. Kupsch) and Klinik für Neurochirurgie (G.-H.S.), Campus Virchow, Charité-Universitätsmedizin Berlin; Praxis Kupsch (A. Kupsch), Berlin, Germany; Service de Neurochirurgie (E.S.) and Service de Neurologie (V.F.), Hôpital Michallon, Centre Hospitalo-Universitaire, Grenoble; Departments of Neurosurgery (P.P.C.), Neurology (F.O.-M., C.B.-C.), and Clinical Pharmacology (C.B.-C.), University Hospital of Toulouse; ToNIC (F.O.-M., C.B.-C.), Toulouse Neuroimaging Center, University of Toulouse, Inserm, UPS, France; Department of Neurosurgery (J. Vesper), Universitätsklinikum Düsseldorf, Germany; Departments of Neurosurgery (S.D.) and Neurology (D.M.), Rouen University Hospital and University of Rouen; INSERM U1239 (D.M.), Laboratory of Neuronal and Neuroendocrine Differentiation and Communication, Mont-Saint-Aignan; Service de Neurologie (P. Damier, P. Derkinderen), CHU Nantes, Hôpital Laënnec, France; Paracelsus-Elena-Klinik Kassel (F.S.-D., C.T.); Department of Neurosurgery (C.T.), University Medical Center Göttingen; Division of Functional and Restorative Neurosurgery and Centre for Integrative Neuroscience (A.G.), Tübingen; Abteilung für Neurologie (T.W.), Reha-Zentrum Bad Gögging, Passauer Wolf; Department for Neurodegenerative Diseases and Hertie Institute for Clinical Brain Research (D.W.), University of Tübingen; Division of Stereotactic and Functional Neurosurgery (M.O.P.), University Medical Center Freiburg, Germany; Departments of Functional and Stereotactic Neurosurgery and Radiosurgery (J.-.M.R.) and Neurology (T.W.), Timone University Hospital, INSERM, Marseille; Institut des Sciences Cognitives Marc Jeannerod (S.T.), CNRS, UMR 5229, Université de Lyon; Centre Expert Parkinson (S.T.), Service de Neurologie C, Hôpital Neurologique Pierre Wertheimer, Hospices Civils de Lyon, Bron; Department of Neurosurgery (P.M.), University Hospital of Neurology and Neurosurgery, Hospices Civils de Lyon, Université de Lyon; Department of Neurology (J.-L.H.), INSERM-1402, Centre Hospitalier Universitaire de Poitiers, University of Poitiers, France; and Universitätsklinikum Giessen und Marburg (L.T.), Marburg Campus, Germany.""}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Wächter', 'Affiliation': ""From the Département de Neurologie (W.M.M.S., A.H., T.D.H., F.P., Y.A., M.V.), Hôpital Pitié-Salpêtrière, Centre d'Investigation Clinique 1422, Institut du Cerveau et de la Moelle Epinière, Institut National de Santé et en Recherche Médicale, Assistance Publique Hôpitaux de Paris, France; Institute of Neurology (W.M.M.S.), Konolfingen; Department of Neurology (W.M.M.S.), University Hospital Bern and University of Bern, Switzerland; Medtronic (L.T.), Minneapolis, MN; Institute of Clinical Neuroscience & Medical Psychology and Department of Neurology (A.D., L.W.), Medical Faculty, Heinrich-Heine-University Düsseldorf, Germany; Movement Disorder Unit, Neurology (P.K.), CHU Grenoble Alpes; Grenoble Institut des Neurosciences (P.K., V.F., A. Kistner), University Grenoble Alpes; Inserm U1216 (P.K., V.F., A. Kistner), Grenoble, France; Department of Clinical Neurosciences (Neurology) (P.K.), Faculty of Medicine, University of Geneva, Switzerland; Coordinating Center for clinical trials of the Philipps University of Marburg (J.R., C.S.-B.); Neurochirurgische Klinik im Neurozentrum (A.F., L.P., S.P., J. Volkmann, K.K., G.D.),Christian-Albrechts-Universität Kiel; Neurologische Klinik und Poliklinik (J. Volkmann), Universitätsklinikum Würzburg; Department of Neurology (H.S.D., M.T.B., G.R.F., L.T.), University Hospital Cologne; Research Centre Jülich (G.R.F.); Klinik für Neurologie (T.D.H., A. Kühn, A. Kupsch) and Klinik für Neurochirurgie (G.-H.S.), Campus Virchow, Charité-Universitätsmedizin Berlin; Praxis Kupsch (A. Kupsch), Berlin, Germany; Service de Neurochirurgie (E.S.) and Service de Neurologie (V.F.), Hôpital Michallon, Centre Hospitalo-Universitaire, Grenoble; Departments of Neurosurgery (P.P.C.), Neurology (F.O.-M., C.B.-C.), and Clinical Pharmacology (C.B.-C.), University Hospital of Toulouse; ToNIC (F.O.-M., C.B.-C.), Toulouse Neuroimaging Center, University of Toulouse, Inserm, UPS, France; Department of Neurosurgery (J. Vesper), Universitätsklinikum Düsseldorf, Germany; Departments of Neurosurgery (S.D.) and Neurology (D.M.), Rouen University Hospital and University of Rouen; INSERM U1239 (D.M.), Laboratory of Neuronal and Neuroendocrine Differentiation and Communication, Mont-Saint-Aignan; Service de Neurologie (P. Damier, P. Derkinderen), CHU Nantes, Hôpital Laënnec, France; Paracelsus-Elena-Klinik Kassel (F.S.-D., C.T.); Department of Neurosurgery (C.T.), University Medical Center Göttingen; Division of Functional and Restorative Neurosurgery and Centre for Integrative Neuroscience (A.G.), Tübingen; Abteilung für Neurologie (T.W.), Reha-Zentrum Bad Gögging, Passauer Wolf; Department for Neurodegenerative Diseases and Hertie Institute for Clinical Brain Research (D.W.), University of Tübingen; Division of Stereotactic and Functional Neurosurgery (M.O.P.), University Medical Center Freiburg, Germany; Departments of Functional and Stereotactic Neurosurgery and Radiosurgery (J.-.M.R.) and Neurology (T.W.), Timone University Hospital, INSERM, Marseille; Institut des Sciences Cognitives Marc Jeannerod (S.T.), CNRS, UMR 5229, Université de Lyon; Centre Expert Parkinson (S.T.), Service de Neurologie C, Hôpital Neurologique Pierre Wertheimer, Hospices Civils de Lyon, Bron; Department of Neurosurgery (P.M.), University Hospital of Neurology and Neurosurgery, Hospices Civils de Lyon, Université de Lyon; Department of Neurology (J.-L.H.), INSERM-1402, Centre Hospitalier Universitaire de Poitiers, University of Poitiers, France; and Universitätsklinikum Giessen und Marburg (L.T.), Marburg Campus, Germany.""}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Weiss', 'Affiliation': ""From the Département de Neurologie (W.M.M.S., A.H., T.D.H., F.P., Y.A., M.V.), Hôpital Pitié-Salpêtrière, Centre d'Investigation Clinique 1422, Institut du Cerveau et de la Moelle Epinière, Institut National de Santé et en Recherche Médicale, Assistance Publique Hôpitaux de Paris, France; Institute of Neurology (W.M.M.S.), Konolfingen; Department of Neurology (W.M.M.S.), University Hospital Bern and University of Bern, Switzerland; Medtronic (L.T.), Minneapolis, MN; Institute of Clinical Neuroscience & Medical Psychology and Department of Neurology (A.D., L.W.), Medical Faculty, Heinrich-Heine-University Düsseldorf, Germany; Movement Disorder Unit, Neurology (P.K.), CHU Grenoble Alpes; Grenoble Institut des Neurosciences (P.K., V.F., A. Kistner), University Grenoble Alpes; Inserm U1216 (P.K., V.F., A. Kistner), Grenoble, France; Department of Clinical Neurosciences (Neurology) (P.K.), Faculty of Medicine, University of Geneva, Switzerland; Coordinating Center for clinical trials of the Philipps University of Marburg (J.R., C.S.-B.); Neurochirurgische Klinik im Neurozentrum (A.F., L.P., S.P., J. Volkmann, K.K., G.D.),Christian-Albrechts-Universität Kiel; Neurologische Klinik und Poliklinik (J. Volkmann), Universitätsklinikum Würzburg; Department of Neurology (H.S.D., M.T.B., G.R.F., L.T.), University Hospital Cologne; Research Centre Jülich (G.R.F.); Klinik für Neurologie (T.D.H., A. Kühn, A. Kupsch) and Klinik für Neurochirurgie (G.-H.S.), Campus Virchow, Charité-Universitätsmedizin Berlin; Praxis Kupsch (A. Kupsch), Berlin, Germany; Service de Neurochirurgie (E.S.) and Service de Neurologie (V.F.), Hôpital Michallon, Centre Hospitalo-Universitaire, Grenoble; Departments of Neurosurgery (P.P.C.), Neurology (F.O.-M., C.B.-C.), and Clinical Pharmacology (C.B.-C.), University Hospital of Toulouse; ToNIC (F.O.-M., C.B.-C.), Toulouse Neuroimaging Center, University of Toulouse, Inserm, UPS, France; Department of Neurosurgery (J. Vesper), Universitätsklinikum Düsseldorf, Germany; Departments of Neurosurgery (S.D.) and Neurology (D.M.), Rouen University Hospital and University of Rouen; INSERM U1239 (D.M.), Laboratory of Neuronal and Neuroendocrine Differentiation and Communication, Mont-Saint-Aignan; Service de Neurologie (P. Damier, P. Derkinderen), CHU Nantes, Hôpital Laënnec, France; Paracelsus-Elena-Klinik Kassel (F.S.-D., C.T.); Department of Neurosurgery (C.T.), University Medical Center Göttingen; Division of Functional and Restorative Neurosurgery and Centre for Integrative Neuroscience (A.G.), Tübingen; Abteilung für Neurologie (T.W.), Reha-Zentrum Bad Gögging, Passauer Wolf; Department for Neurodegenerative Diseases and Hertie Institute for Clinical Brain Research (D.W.), University of Tübingen; Division of Stereotactic and Functional Neurosurgery (M.O.P.), University Medical Center Freiburg, Germany; Departments of Functional and Stereotactic Neurosurgery and Radiosurgery (J.-.M.R.) and Neurology (T.W.), Timone University Hospital, INSERM, Marseille; Institut des Sciences Cognitives Marc Jeannerod (S.T.), CNRS, UMR 5229, Université de Lyon; Centre Expert Parkinson (S.T.), Service de Neurologie C, Hôpital Neurologique Pierre Wertheimer, Hospices Civils de Lyon, Bron; Department of Neurosurgery (P.M.), University Hospital of Neurology and Neurosurgery, Hospices Civils de Lyon, Université de Lyon; Department of Neurology (J.-L.H.), INSERM-1402, Centre Hospitalier Universitaire de Poitiers, University of Poitiers, France; and Universitätsklinikum Giessen und Marburg (L.T.), Marburg Campus, Germany.""}, {'ForeName': 'Marcus O', 'Initials': 'MO', 'LastName': 'Pinsker', 'Affiliation': ""From the Département de Neurologie (W.M.M.S., A.H., T.D.H., F.P., Y.A., M.V.), Hôpital Pitié-Salpêtrière, Centre d'Investigation Clinique 1422, Institut du Cerveau et de la Moelle Epinière, Institut National de Santé et en Recherche Médicale, Assistance Publique Hôpitaux de Paris, France; Institute of Neurology (W.M.M.S.), Konolfingen; Department of Neurology (W.M.M.S.), University Hospital Bern and University of Bern, Switzerland; Medtronic (L.T.), Minneapolis, MN; Institute of Clinical Neuroscience & Medical Psychology and Department of Neurology (A.D., L.W.), Medical Faculty, Heinrich-Heine-University Düsseldorf, Germany; Movement Disorder Unit, Neurology (P.K.), CHU Grenoble Alpes; Grenoble Institut des Neurosciences (P.K., V.F., A. Kistner), University Grenoble Alpes; Inserm U1216 (P.K., V.F., A. Kistner), Grenoble, France; Department of Clinical Neurosciences (Neurology) (P.K.), Faculty of Medicine, University of Geneva, Switzerland; Coordinating Center for clinical trials of the Philipps University of Marburg (J.R., C.S.-B.); Neurochirurgische Klinik im Neurozentrum (A.F., L.P., S.P., J. Volkmann, K.K., G.D.),Christian-Albrechts-Universität Kiel; Neurologische Klinik und Poliklinik (J. Volkmann), Universitätsklinikum Würzburg; Department of Neurology (H.S.D., M.T.B., G.R.F., L.T.), University Hospital Cologne; Research Centre Jülich (G.R.F.); Klinik für Neurologie (T.D.H., A. Kühn, A. Kupsch) and Klinik für Neurochirurgie (G.-H.S.), Campus Virchow, Charité-Universitätsmedizin Berlin; Praxis Kupsch (A. Kupsch), Berlin, Germany; Service de Neurochirurgie (E.S.) and Service de Neurologie (V.F.), Hôpital Michallon, Centre Hospitalo-Universitaire, Grenoble; Departments of Neurosurgery (P.P.C.), Neurology (F.O.-M., C.B.-C.), and Clinical Pharmacology (C.B.-C.), University Hospital of Toulouse; ToNIC (F.O.-M., C.B.-C.), Toulouse Neuroimaging Center, University of Toulouse, Inserm, UPS, France; Department of Neurosurgery (J. Vesper), Universitätsklinikum Düsseldorf, Germany; Departments of Neurosurgery (S.D.) and Neurology (D.M.), Rouen University Hospital and University of Rouen; INSERM U1239 (D.M.), Laboratory of Neuronal and Neuroendocrine Differentiation and Communication, Mont-Saint-Aignan; Service de Neurologie (P. Damier, P. Derkinderen), CHU Nantes, Hôpital Laënnec, France; Paracelsus-Elena-Klinik Kassel (F.S.-D., C.T.); Department of Neurosurgery (C.T.), University Medical Center Göttingen; Division of Functional and Restorative Neurosurgery and Centre for Integrative Neuroscience (A.G.), Tübingen; Abteilung für Neurologie (T.W.), Reha-Zentrum Bad Gögging, Passauer Wolf; Department for Neurodegenerative Diseases and Hertie Institute for Clinical Brain Research (D.W.), University of Tübingen; Division of Stereotactic and Functional Neurosurgery (M.O.P.), University Medical Center Freiburg, Germany; Departments of Functional and Stereotactic Neurosurgery and Radiosurgery (J.-.M.R.) and Neurology (T.W.), Timone University Hospital, INSERM, Marseille; Institut des Sciences Cognitives Marc Jeannerod (S.T.), CNRS, UMR 5229, Université de Lyon; Centre Expert Parkinson (S.T.), Service de Neurologie C, Hôpital Neurologique Pierre Wertheimer, Hospices Civils de Lyon, Bron; Department of Neurosurgery (P.M.), University Hospital of Neurology and Neurosurgery, Hospices Civils de Lyon, Université de Lyon; Department of Neurology (J.-L.H.), INSERM-1402, Centre Hospitalier Universitaire de Poitiers, University of Poitiers, France; and Universitätsklinikum Giessen und Marburg (L.T.), Marburg Campus, Germany.""}, {'ForeName': 'Jean-Marie', 'Initials': 'JM', 'LastName': 'Regis', 'Affiliation': ""From the Département de Neurologie (W.M.M.S., A.H., T.D.H., F.P., Y.A., M.V.), Hôpital Pitié-Salpêtrière, Centre d'Investigation Clinique 1422, Institut du Cerveau et de la Moelle Epinière, Institut National de Santé et en Recherche Médicale, Assistance Publique Hôpitaux de Paris, France; Institute of Neurology (W.M.M.S.), Konolfingen; Department of Neurology (W.M.M.S.), University Hospital Bern and University of Bern, Switzerland; Medtronic (L.T.), Minneapolis, MN; Institute of Clinical Neuroscience & Medical Psychology and Department of Neurology (A.D., L.W.), Medical Faculty, Heinrich-Heine-University Düsseldorf, Germany; Movement Disorder Unit, Neurology (P.K.), CHU Grenoble Alpes; Grenoble Institut des Neurosciences (P.K., V.F., A. Kistner), University Grenoble Alpes; Inserm U1216 (P.K., V.F., A. Kistner), Grenoble, France; Department of Clinical Neurosciences (Neurology) (P.K.), Faculty of Medicine, University of Geneva, Switzerland; Coordinating Center for clinical trials of the Philipps University of Marburg (J.R., C.S.-B.); Neurochirurgische Klinik im Neurozentrum (A.F., L.P., S.P., J. Volkmann, K.K., G.D.),Christian-Albrechts-Universität Kiel; Neurologische Klinik und Poliklinik (J. Volkmann), Universitätsklinikum Würzburg; Department of Neurology (H.S.D., M.T.B., G.R.F., L.T.), University Hospital Cologne; Research Centre Jülich (G.R.F.); Klinik für Neurologie (T.D.H., A. Kühn, A. Kupsch) and Klinik für Neurochirurgie (G.-H.S.), Campus Virchow, Charité-Universitätsmedizin Berlin; Praxis Kupsch (A. Kupsch), Berlin, Germany; Service de Neurochirurgie (E.S.) and Service de Neurologie (V.F.), Hôpital Michallon, Centre Hospitalo-Universitaire, Grenoble; Departments of Neurosurgery (P.P.C.), Neurology (F.O.-M., C.B.-C.), and Clinical Pharmacology (C.B.-C.), University Hospital of Toulouse; ToNIC (F.O.-M., C.B.-C.), Toulouse Neuroimaging Center, University of Toulouse, Inserm, UPS, France; Department of Neurosurgery (J. Vesper), Universitätsklinikum Düsseldorf, Germany; Departments of Neurosurgery (S.D.) and Neurology (D.M.), Rouen University Hospital and University of Rouen; INSERM U1239 (D.M.), Laboratory of Neuronal and Neuroendocrine Differentiation and Communication, Mont-Saint-Aignan; Service de Neurologie (P. Damier, P. Derkinderen), CHU Nantes, Hôpital Laënnec, France; Paracelsus-Elena-Klinik Kassel (F.S.-D., C.T.); Department of Neurosurgery (C.T.), University Medical Center Göttingen; Division of Functional and Restorative Neurosurgery and Centre for Integrative Neuroscience (A.G.), Tübingen; Abteilung für Neurologie (T.W.), Reha-Zentrum Bad Gögging, Passauer Wolf; Department for Neurodegenerative Diseases and Hertie Institute for Clinical Brain Research (D.W.), University of Tübingen; Division of Stereotactic and Functional Neurosurgery (M.O.P.), University Medical Center Freiburg, Germany; Departments of Functional and Stereotactic Neurosurgery and Radiosurgery (J.-.M.R.) and Neurology (T.W.), Timone University Hospital, INSERM, Marseille; Institut des Sciences Cognitives Marc Jeannerod (S.T.), CNRS, UMR 5229, Université de Lyon; Centre Expert Parkinson (S.T.), Service de Neurologie C, Hôpital Neurologique Pierre Wertheimer, Hospices Civils de Lyon, Bron; Department of Neurosurgery (P.M.), University Hospital of Neurology and Neurosurgery, Hospices Civils de Lyon, Université de Lyon; Department of Neurology (J.-L.H.), INSERM-1402, Centre Hospitalier Universitaire de Poitiers, University of Poitiers, France; and Universitätsklinikum Giessen und Marburg (L.T.), Marburg Campus, Germany.""}, {'ForeName': 'Tatiana', 'Initials': 'T', 'LastName': 'Witjas', 'Affiliation': ""From the Département de Neurologie (W.M.M.S., A.H., T.D.H., F.P., Y.A., M.V.), Hôpital Pitié-Salpêtrière, Centre d'Investigation Clinique 1422, Institut du Cerveau et de la Moelle Epinière, Institut National de Santé et en Recherche Médicale, Assistance Publique Hôpitaux de Paris, France; Institute of Neurology (W.M.M.S.), Konolfingen; Department of Neurology (W.M.M.S.), University Hospital Bern and University of Bern, Switzerland; Medtronic (L.T.), Minneapolis, MN; Institute of Clinical Neuroscience & Medical Psychology and Department of Neurology (A.D., L.W.), Medical Faculty, Heinrich-Heine-University Düsseldorf, Germany; Movement Disorder Unit, Neurology (P.K.), CHU Grenoble Alpes; Grenoble Institut des Neurosciences (P.K., V.F., A. Kistner), University Grenoble Alpes; Inserm U1216 (P.K., V.F., A. Kistner), Grenoble, France; Department of Clinical Neurosciences (Neurology) (P.K.), Faculty of Medicine, University of Geneva, Switzerland; Coordinating Center for clinical trials of the Philipps University of Marburg (J.R., C.S.-B.); Neurochirurgische Klinik im Neurozentrum (A.F., L.P., S.P., J. Volkmann, K.K., G.D.),Christian-Albrechts-Universität Kiel; Neurologische Klinik und Poliklinik (J. Volkmann), Universitätsklinikum Würzburg; Department of Neurology (H.S.D., M.T.B., G.R.F., L.T.), University Hospital Cologne; Research Centre Jülich (G.R.F.); Klinik für Neurologie (T.D.H., A. Kühn, A. Kupsch) and Klinik für Neurochirurgie (G.-H.S.), Campus Virchow, Charité-Universitätsmedizin Berlin; Praxis Kupsch (A. Kupsch), Berlin, Germany; Service de Neurochirurgie (E.S.) and Service de Neurologie (V.F.), Hôpital Michallon, Centre Hospitalo-Universitaire, Grenoble; Departments of Neurosurgery (P.P.C.), Neurology (F.O.-M., C.B.-C.), and Clinical Pharmacology (C.B.-C.), University Hospital of Toulouse; ToNIC (F.O.-M., C.B.-C.), Toulouse Neuroimaging Center, University of Toulouse, Inserm, UPS, France; Department of Neurosurgery (J. Vesper), Universitätsklinikum Düsseldorf, Germany; Departments of Neurosurgery (S.D.) and Neurology (D.M.), Rouen University Hospital and University of Rouen; INSERM U1239 (D.M.), Laboratory of Neuronal and Neuroendocrine Differentiation and Communication, Mont-Saint-Aignan; Service de Neurologie (P. Damier, P. Derkinderen), CHU Nantes, Hôpital Laënnec, France; Paracelsus-Elena-Klinik Kassel (F.S.-D., C.T.); Department of Neurosurgery (C.T.), University Medical Center Göttingen; Division of Functional and Restorative Neurosurgery and Centre for Integrative Neuroscience (A.G.), Tübingen; Abteilung für Neurologie (T.W.), Reha-Zentrum Bad Gögging, Passauer Wolf; Department for Neurodegenerative Diseases and Hertie Institute for Clinical Brain Research (D.W.), University of Tübingen; Division of Stereotactic and Functional Neurosurgery (M.O.P.), University Medical Center Freiburg, Germany; Departments of Functional and Stereotactic Neurosurgery and Radiosurgery (J.-.M.R.) and Neurology (T.W.), Timone University Hospital, INSERM, Marseille; Institut des Sciences Cognitives Marc Jeannerod (S.T.), CNRS, UMR 5229, Université de Lyon; Centre Expert Parkinson (S.T.), Service de Neurologie C, Hôpital Neurologique Pierre Wertheimer, Hospices Civils de Lyon, Bron; Department of Neurosurgery (P.M.), University Hospital of Neurology and Neurosurgery, Hospices Civils de Lyon, Université de Lyon; Department of Neurology (J.-L.H.), INSERM-1402, Centre Hospitalier Universitaire de Poitiers, University of Poitiers, France; and Universitätsklinikum Giessen und Marburg (L.T.), Marburg Campus, Germany.""}, {'ForeName': 'Stephane', 'Initials': 'S', 'LastName': 'Thobois', 'Affiliation': ""From the Département de Neurologie (W.M.M.S., A.H., T.D.H., F.P., Y.A., M.V.), Hôpital Pitié-Salpêtrière, Centre d'Investigation Clinique 1422, Institut du Cerveau et de la Moelle Epinière, Institut National de Santé et en Recherche Médicale, Assistance Publique Hôpitaux de Paris, France; Institute of Neurology (W.M.M.S.), Konolfingen; Department of Neurology (W.M.M.S.), University Hospital Bern and University of Bern, Switzerland; Medtronic (L.T.), Minneapolis, MN; Institute of Clinical Neuroscience & Medical Psychology and Department of Neurology (A.D., L.W.), Medical Faculty, Heinrich-Heine-University Düsseldorf, Germany; Movement Disorder Unit, Neurology (P.K.), CHU Grenoble Alpes; Grenoble Institut des Neurosciences (P.K., V.F., A. Kistner), University Grenoble Alpes; Inserm U1216 (P.K., V.F., A. Kistner), Grenoble, France; Department of Clinical Neurosciences (Neurology) (P.K.), Faculty of Medicine, University of Geneva, Switzerland; Coordinating Center for clinical trials of the Philipps University of Marburg (J.R., C.S.-B.); Neurochirurgische Klinik im Neurozentrum (A.F., L.P., S.P., J. Volkmann, K.K., G.D.),Christian-Albrechts-Universität Kiel; Neurologische Klinik und Poliklinik (J. Volkmann), Universitätsklinikum Würzburg; Department of Neurology (H.S.D., M.T.B., G.R.F., L.T.), University Hospital Cologne; Research Centre Jülich (G.R.F.); Klinik für Neurologie (T.D.H., A. Kühn, A. Kupsch) and Klinik für Neurochirurgie (G.-H.S.), Campus Virchow, Charité-Universitätsmedizin Berlin; Praxis Kupsch (A. Kupsch), Berlin, Germany; Service de Neurochirurgie (E.S.) and Service de Neurologie (V.F.), Hôpital Michallon, Centre Hospitalo-Universitaire, Grenoble; Departments of Neurosurgery (P.P.C.), Neurology (F.O.-M., C.B.-C.), and Clinical Pharmacology (C.B.-C.), University Hospital of Toulouse; ToNIC (F.O.-M., C.B.-C.), Toulouse Neuroimaging Center, University of Toulouse, Inserm, UPS, France; Department of Neurosurgery (J. Vesper), Universitätsklinikum Düsseldorf, Germany; Departments of Neurosurgery (S.D.) and Neurology (D.M.), Rouen University Hospital and University of Rouen; INSERM U1239 (D.M.), Laboratory of Neuronal and Neuroendocrine Differentiation and Communication, Mont-Saint-Aignan; Service de Neurologie (P. Damier, P. Derkinderen), CHU Nantes, Hôpital Laënnec, France; Paracelsus-Elena-Klinik Kassel (F.S.-D., C.T.); Department of Neurosurgery (C.T.), University Medical Center Göttingen; Division of Functional and Restorative Neurosurgery and Centre for Integrative Neuroscience (A.G.), Tübingen; Abteilung für Neurologie (T.W.), Reha-Zentrum Bad Gögging, Passauer Wolf; Department for Neurodegenerative Diseases and Hertie Institute for Clinical Brain Research (D.W.), University of Tübingen; Division of Stereotactic and Functional Neurosurgery (M.O.P.), University Medical Center Freiburg, Germany; Departments of Functional and Stereotactic Neurosurgery and Radiosurgery (J.-.M.R.) and Neurology (T.W.), Timone University Hospital, INSERM, Marseille; Institut des Sciences Cognitives Marc Jeannerod (S.T.), CNRS, UMR 5229, Université de Lyon; Centre Expert Parkinson (S.T.), Service de Neurologie C, Hôpital Neurologique Pierre Wertheimer, Hospices Civils de Lyon, Bron; Department of Neurosurgery (P.M.), University Hospital of Neurology and Neurosurgery, Hospices Civils de Lyon, Université de Lyon; Department of Neurology (J.-L.H.), INSERM-1402, Centre Hospitalier Universitaire de Poitiers, University of Poitiers, France; and Universitätsklinikum Giessen und Marburg (L.T.), Marburg Campus, Germany.""}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Mertens', 'Affiliation': ""From the Département de Neurologie (W.M.M.S., A.H., T.D.H., F.P., Y.A., M.V.), Hôpital Pitié-Salpêtrière, Centre d'Investigation Clinique 1422, Institut du Cerveau et de la Moelle Epinière, Institut National de Santé et en Recherche Médicale, Assistance Publique Hôpitaux de Paris, France; Institute of Neurology (W.M.M.S.), Konolfingen; Department of Neurology (W.M.M.S.), University Hospital Bern and University of Bern, Switzerland; Medtronic (L.T.), Minneapolis, MN; Institute of Clinical Neuroscience & Medical Psychology and Department of Neurology (A.D., L.W.), Medical Faculty, Heinrich-Heine-University Düsseldorf, Germany; Movement Disorder Unit, Neurology (P.K.), CHU Grenoble Alpes; Grenoble Institut des Neurosciences (P.K., V.F., A. Kistner), University Grenoble Alpes; Inserm U1216 (P.K., V.F., A. Kistner), Grenoble, France; Department of Clinical Neurosciences (Neurology) (P.K.), Faculty of Medicine, University of Geneva, Switzerland; Coordinating Center for clinical trials of the Philipps University of Marburg (J.R., C.S.-B.); Neurochirurgische Klinik im Neurozentrum (A.F., L.P., S.P., J. Volkmann, K.K., G.D.),Christian-Albrechts-Universität Kiel; Neurologische Klinik und Poliklinik (J. Volkmann), Universitätsklinikum Würzburg; Department of Neurology (H.S.D., M.T.B., G.R.F., L.T.), University Hospital Cologne; Research Centre Jülich (G.R.F.); Klinik für Neurologie (T.D.H., A. Kühn, A. Kupsch) and Klinik für Neurochirurgie (G.-H.S.), Campus Virchow, Charité-Universitätsmedizin Berlin; Praxis Kupsch (A. Kupsch), Berlin, Germany; Service de Neurochirurgie (E.S.) and Service de Neurologie (V.F.), Hôpital Michallon, Centre Hospitalo-Universitaire, Grenoble; Departments of Neurosurgery (P.P.C.), Neurology (F.O.-M., C.B.-C.), and Clinical Pharmacology (C.B.-C.), University Hospital of Toulouse; ToNIC (F.O.-M., C.B.-C.), Toulouse Neuroimaging Center, University of Toulouse, Inserm, UPS, France; Department of Neurosurgery (J. Vesper), Universitätsklinikum Düsseldorf, Germany; Departments of Neurosurgery (S.D.) and Neurology (D.M.), Rouen University Hospital and University of Rouen; INSERM U1239 (D.M.), Laboratory of Neuronal and Neuroendocrine Differentiation and Communication, Mont-Saint-Aignan; Service de Neurologie (P. Damier, P. Derkinderen), CHU Nantes, Hôpital Laënnec, France; Paracelsus-Elena-Klinik Kassel (F.S.-D., C.T.); Department of Neurosurgery (C.T.), University Medical Center Göttingen; Division of Functional and Restorative Neurosurgery and Centre for Integrative Neuroscience (A.G.), Tübingen; Abteilung für Neurologie (T.W.), Reha-Zentrum Bad Gögging, Passauer Wolf; Department for Neurodegenerative Diseases and Hertie Institute for Clinical Brain Research (D.W.), University of Tübingen; Division of Stereotactic and Functional Neurosurgery (M.O.P.), University Medical Center Freiburg, Germany; Departments of Functional and Stereotactic Neurosurgery and Radiosurgery (J.-.M.R.) and Neurology (T.W.), Timone University Hospital, INSERM, Marseille; Institut des Sciences Cognitives Marc Jeannerod (S.T.), CNRS, UMR 5229, Université de Lyon; Centre Expert Parkinson (S.T.), Service de Neurologie C, Hôpital Neurologique Pierre Wertheimer, Hospices Civils de Lyon, Bron; Department of Neurosurgery (P.M.), University Hospital of Neurology and Neurosurgery, Hospices Civils de Lyon, Université de Lyon; Department of Neurology (J.-L.H.), INSERM-1402, Centre Hospitalier Universitaire de Poitiers, University of Poitiers, France; and Universitätsklinikum Giessen und Marburg (L.T.), Marburg Campus, Germany.""}, {'ForeName': 'Karina', 'Initials': 'K', 'LastName': 'Knudsen', 'Affiliation': ""From the Département de Neurologie (W.M.M.S., A.H., T.D.H., F.P., Y.A., M.V.), Hôpital Pitié-Salpêtrière, Centre d'Investigation Clinique 1422, Institut du Cerveau et de la Moelle Epinière, Institut National de Santé et en Recherche Médicale, Assistance Publique Hôpitaux de Paris, France; Institute of Neurology (W.M.M.S.), Konolfingen; Department of Neurology (W.M.M.S.), University Hospital Bern and University of Bern, Switzerland; Medtronic (L.T.), Minneapolis, MN; Institute of Clinical Neuroscience & Medical Psychology and Department of Neurology (A.D., L.W.), Medical Faculty, Heinrich-Heine-University Düsseldorf, Germany; Movement Disorder Unit, Neurology (P.K.), CHU Grenoble Alpes; Grenoble Institut des Neurosciences (P.K., V.F., A. Kistner), University Grenoble Alpes; Inserm U1216 (P.K., V.F., A. Kistner), Grenoble, France; Department of Clinical Neurosciences (Neurology) (P.K.), Faculty of Medicine, University of Geneva, Switzerland; Coordinating Center for clinical trials of the Philipps University of Marburg (J.R., C.S.-B.); Neurochirurgische Klinik im Neurozentrum (A.F., L.P., S.P., J. Volkmann, K.K., G.D.),Christian-Albrechts-Universität Kiel; Neurologische Klinik und Poliklinik (J. Volkmann), Universitätsklinikum Würzburg; Department of Neurology (H.S.D., M.T.B., G.R.F., L.T.), University Hospital Cologne; Research Centre Jülich (G.R.F.); Klinik für Neurologie (T.D.H., A. Kühn, A. Kupsch) and Klinik für Neurochirurgie (G.-H.S.), Campus Virchow, Charité-Universitätsmedizin Berlin; Praxis Kupsch (A. Kupsch), Berlin, Germany; Service de Neurochirurgie (E.S.) and Service de Neurologie (V.F.), Hôpital Michallon, Centre Hospitalo-Universitaire, Grenoble; Departments of Neurosurgery (P.P.C.), Neurology (F.O.-M., C.B.-C.), and Clinical Pharmacology (C.B.-C.), University Hospital of Toulouse; ToNIC (F.O.-M., C.B.-C.), Toulouse Neuroimaging Center, University of Toulouse, Inserm, UPS, France; Department of Neurosurgery (J. Vesper), Universitätsklinikum Düsseldorf, Germany; Departments of Neurosurgery (S.D.) and Neurology (D.M.), Rouen University Hospital and University of Rouen; INSERM U1239 (D.M.), Laboratory of Neuronal and Neuroendocrine Differentiation and Communication, Mont-Saint-Aignan; Service de Neurologie (P. Damier, P. Derkinderen), CHU Nantes, Hôpital Laënnec, France; Paracelsus-Elena-Klinik Kassel (F.S.-D., C.T.); Department of Neurosurgery (C.T.), University Medical Center Göttingen; Division of Functional and Restorative Neurosurgery and Centre for Integrative Neuroscience (A.G.), Tübingen; Abteilung für Neurologie (T.W.), Reha-Zentrum Bad Gögging, Passauer Wolf; Department for Neurodegenerative Diseases and Hertie Institute for Clinical Brain Research (D.W.), University of Tübingen; Division of Stereotactic and Functional Neurosurgery (M.O.P.), University Medical Center Freiburg, Germany; Departments of Functional and Stereotactic Neurosurgery and Radiosurgery (J.-.M.R.) and Neurology (T.W.), Timone University Hospital, INSERM, Marseille; Institut des Sciences Cognitives Marc Jeannerod (S.T.), CNRS, UMR 5229, Université de Lyon; Centre Expert Parkinson (S.T.), Service de Neurologie C, Hôpital Neurologique Pierre Wertheimer, Hospices Civils de Lyon, Bron; Department of Neurosurgery (P.M.), University Hospital of Neurology and Neurosurgery, Hospices Civils de Lyon, Université de Lyon; Department of Neurology (J.-L.H.), INSERM-1402, Centre Hospitalier Universitaire de Poitiers, University of Poitiers, France; and Universitätsklinikum Giessen und Marburg (L.T.), Marburg Campus, Germany.""}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Schade-Brittinger', 'Affiliation': ""From the Département de Neurologie (W.M.M.S., A.H., T.D.H., F.P., Y.A., M.V.), Hôpital Pitié-Salpêtrière, Centre d'Investigation Clinique 1422, Institut du Cerveau et de la Moelle Epinière, Institut National de Santé et en Recherche Médicale, Assistance Publique Hôpitaux de Paris, France; Institute of Neurology (W.M.M.S.), Konolfingen; Department of Neurology (W.M.M.S.), University Hospital Bern and University of Bern, Switzerland; Medtronic (L.T.), Minneapolis, MN; Institute of Clinical Neuroscience & Medical Psychology and Department of Neurology (A.D., L.W.), Medical Faculty, Heinrich-Heine-University Düsseldorf, Germany; Movement Disorder Unit, Neurology (P.K.), CHU Grenoble Alpes; Grenoble Institut des Neurosciences (P.K., V.F., A. Kistner), University Grenoble Alpes; Inserm U1216 (P.K., V.F., A. Kistner), Grenoble, France; Department of Clinical Neurosciences (Neurology) (P.K.), Faculty of Medicine, University of Geneva, Switzerland; Coordinating Center for clinical trials of the Philipps University of Marburg (J.R., C.S.-B.); Neurochirurgische Klinik im Neurozentrum (A.F., L.P., S.P., J. Volkmann, K.K., G.D.),Christian-Albrechts-Universität Kiel; Neurologische Klinik und Poliklinik (J. Volkmann), Universitätsklinikum Würzburg; Department of Neurology (H.S.D., M.T.B., G.R.F., L.T.), University Hospital Cologne; Research Centre Jülich (G.R.F.); Klinik für Neurologie (T.D.H., A. Kühn, A. Kupsch) and Klinik für Neurochirurgie (G.-H.S.), Campus Virchow, Charité-Universitätsmedizin Berlin; Praxis Kupsch (A. Kupsch), Berlin, Germany; Service de Neurochirurgie (E.S.) and Service de Neurologie (V.F.), Hôpital Michallon, Centre Hospitalo-Universitaire, Grenoble; Departments of Neurosurgery (P.P.C.), Neurology (F.O.-M., C.B.-C.), and Clinical Pharmacology (C.B.-C.), University Hospital of Toulouse; ToNIC (F.O.-M., C.B.-C.), Toulouse Neuroimaging Center, University of Toulouse, Inserm, UPS, France; Department of Neurosurgery (J. Vesper), Universitätsklinikum Düsseldorf, Germany; Departments of Neurosurgery (S.D.) and Neurology (D.M.), Rouen University Hospital and University of Rouen; INSERM U1239 (D.M.), Laboratory of Neuronal and Neuroendocrine Differentiation and Communication, Mont-Saint-Aignan; Service de Neurologie (P. Damier, P. Derkinderen), CHU Nantes, Hôpital Laënnec, France; Paracelsus-Elena-Klinik Kassel (F.S.-D., C.T.); Department of Neurosurgery (C.T.), University Medical Center Göttingen; Division of Functional and Restorative Neurosurgery and Centre for Integrative Neuroscience (A.G.), Tübingen; Abteilung für Neurologie (T.W.), Reha-Zentrum Bad Gögging, Passauer Wolf; Department for Neurodegenerative Diseases and Hertie Institute for Clinical Brain Research (D.W.), University of Tübingen; Division of Stereotactic and Functional Neurosurgery (M.O.P.), University Medical Center Freiburg, Germany; Departments of Functional and Stereotactic Neurosurgery and Radiosurgery (J.-.M.R.) and Neurology (T.W.), Timone University Hospital, INSERM, Marseille; Institut des Sciences Cognitives Marc Jeannerod (S.T.), CNRS, UMR 5229, Université de Lyon; Centre Expert Parkinson (S.T.), Service de Neurologie C, Hôpital Neurologique Pierre Wertheimer, Hospices Civils de Lyon, Bron; Department of Neurosurgery (P.M.), University Hospital of Neurology and Neurosurgery, Hospices Civils de Lyon, Université de Lyon; Department of Neurology (J.-L.H.), INSERM-1402, Centre Hospitalier Universitaire de Poitiers, University of Poitiers, France; and Universitätsklinikum Giessen und Marburg (L.T.), Marburg Campus, Germany.""}, {'ForeName': 'Jean-Luc', 'Initials': 'JL', 'LastName': 'Houeto', 'Affiliation': ""From the Département de Neurologie (W.M.M.S., A.H., T.D.H., F.P., Y.A., M.V.), Hôpital Pitié-Salpêtrière, Centre d'Investigation Clinique 1422, Institut du Cerveau et de la Moelle Epinière, Institut National de Santé et en Recherche Médicale, Assistance Publique Hôpitaux de Paris, France; Institute of Neurology (W.M.M.S.), Konolfingen; Department of Neurology (W.M.M.S.), University Hospital Bern and University of Bern, Switzerland; Medtronic (L.T.), Minneapolis, MN; Institute of Clinical Neuroscience & Medical Psychology and Department of Neurology (A.D., L.W.), Medical Faculty, Heinrich-Heine-University Düsseldorf, Germany; Movement Disorder Unit, Neurology (P.K.), CHU Grenoble Alpes; Grenoble Institut des Neurosciences (P.K., V.F., A. Kistner), University Grenoble Alpes; Inserm U1216 (P.K., V.F., A. Kistner), Grenoble, France; Department of Clinical Neurosciences (Neurology) (P.K.), Faculty of Medicine, University of Geneva, Switzerland; Coordinating Center for clinical trials of the Philipps University of Marburg (J.R., C.S.-B.); Neurochirurgische Klinik im Neurozentrum (A.F., L.P., S.P., J. Volkmann, K.K., G.D.),Christian-Albrechts-Universität Kiel; Neurologische Klinik und Poliklinik (J. Volkmann), Universitätsklinikum Würzburg; Department of Neurology (H.S.D., M.T.B., G.R.F., L.T.), University Hospital Cologne; Research Centre Jülich (G.R.F.); Klinik für Neurologie (T.D.H., A. Kühn, A. Kupsch) and Klinik für Neurochirurgie (G.-H.S.), Campus Virchow, Charité-Universitätsmedizin Berlin; Praxis Kupsch (A. Kupsch), Berlin, Germany; Service de Neurochirurgie (E.S.) and Service de Neurologie (V.F.), Hôpital Michallon, Centre Hospitalo-Universitaire, Grenoble; Departments of Neurosurgery (P.P.C.), Neurology (F.O.-M., C.B.-C.), and Clinical Pharmacology (C.B.-C.), University Hospital of Toulouse; ToNIC (F.O.-M., C.B.-C.), Toulouse Neuroimaging Center, University of Toulouse, Inserm, UPS, France; Department of Neurosurgery (J. Vesper), Universitätsklinikum Düsseldorf, Germany; Departments of Neurosurgery (S.D.) and Neurology (D.M.), Rouen University Hospital and University of Rouen; INSERM U1239 (D.M.), Laboratory of Neuronal and Neuroendocrine Differentiation and Communication, Mont-Saint-Aignan; Service de Neurologie (P. Damier, P. Derkinderen), CHU Nantes, Hôpital Laënnec, France; Paracelsus-Elena-Klinik Kassel (F.S.-D., C.T.); Department of Neurosurgery (C.T.), University Medical Center Göttingen; Division of Functional and Restorative Neurosurgery and Centre for Integrative Neuroscience (A.G.), Tübingen; Abteilung für Neurologie (T.W.), Reha-Zentrum Bad Gögging, Passauer Wolf; Department for Neurodegenerative Diseases and Hertie Institute for Clinical Brain Research (D.W.), University of Tübingen; Division of Stereotactic and Functional Neurosurgery (M.O.P.), University Medical Center Freiburg, Germany; Departments of Functional and Stereotactic Neurosurgery and Radiosurgery (J.-.M.R.) and Neurology (T.W.), Timone University Hospital, INSERM, Marseille; Institut des Sciences Cognitives Marc Jeannerod (S.T.), CNRS, UMR 5229, Université de Lyon; Centre Expert Parkinson (S.T.), Service de Neurologie C, Hôpital Neurologique Pierre Wertheimer, Hospices Civils de Lyon, Bron; Department of Neurosurgery (P.M.), University Hospital of Neurology and Neurosurgery, Hospices Civils de Lyon, Université de Lyon; Department of Neurology (J.-L.H.), INSERM-1402, Centre Hospitalier Universitaire de Poitiers, University of Poitiers, France; and Universitätsklinikum Giessen und Marburg (L.T.), Marburg Campus, Germany.""}, {'ForeName': 'Yves', 'Initials': 'Y', 'LastName': 'Agid', 'Affiliation': ""From the Département de Neurologie (W.M.M.S., A.H., T.D.H., F.P., Y.A., M.V.), Hôpital Pitié-Salpêtrière, Centre d'Investigation Clinique 1422, Institut du Cerveau et de la Moelle Epinière, Institut National de Santé et en Recherche Médicale, Assistance Publique Hôpitaux de Paris, France; Institute of Neurology (W.M.M.S.), Konolfingen; Department of Neurology (W.M.M.S.), University Hospital Bern and University of Bern, Switzerland; Medtronic (L.T.), Minneapolis, MN; Institute of Clinical Neuroscience & Medical Psychology and Department of Neurology (A.D., L.W.), Medical Faculty, Heinrich-Heine-University Düsseldorf, Germany; Movement Disorder Unit, Neurology (P.K.), CHU Grenoble Alpes; Grenoble Institut des Neurosciences (P.K., V.F., A. Kistner), University Grenoble Alpes; Inserm U1216 (P.K., V.F., A. Kistner), Grenoble, France; Department of Clinical Neurosciences (Neurology) (P.K.), Faculty of Medicine, University of Geneva, Switzerland; Coordinating Center for clinical trials of the Philipps University of Marburg (J.R., C.S.-B.); Neurochirurgische Klinik im Neurozentrum (A.F., L.P., S.P., J. Volkmann, K.K., G.D.),Christian-Albrechts-Universität Kiel; Neurologische Klinik und Poliklinik (J. Volkmann), Universitätsklinikum Würzburg; Department of Neurology (H.S.D., M.T.B., G.R.F., L.T.), University Hospital Cologne; Research Centre Jülich (G.R.F.); Klinik für Neurologie (T.D.H., A. Kühn, A. Kupsch) and Klinik für Neurochirurgie (G.-H.S.), Campus Virchow, Charité-Universitätsmedizin Berlin; Praxis Kupsch (A. Kupsch), Berlin, Germany; Service de Neurochirurgie (E.S.) and Service de Neurologie (V.F.), Hôpital Michallon, Centre Hospitalo-Universitaire, Grenoble; Departments of Neurosurgery (P.P.C.), Neurology (F.O.-M., C.B.-C.), and Clinical Pharmacology (C.B.-C.), University Hospital of Toulouse; ToNIC (F.O.-M., C.B.-C.), Toulouse Neuroimaging Center, University of Toulouse, Inserm, UPS, France; Department of Neurosurgery (J. Vesper), Universitätsklinikum Düsseldorf, Germany; Departments of Neurosurgery (S.D.) and Neurology (D.M.), Rouen University Hospital and University of Rouen; INSERM U1239 (D.M.), Laboratory of Neuronal and Neuroendocrine Differentiation and Communication, Mont-Saint-Aignan; Service de Neurologie (P. Damier, P. Derkinderen), CHU Nantes, Hôpital Laënnec, France; Paracelsus-Elena-Klinik Kassel (F.S.-D., C.T.); Department of Neurosurgery (C.T.), University Medical Center Göttingen; Division of Functional and Restorative Neurosurgery and Centre for Integrative Neuroscience (A.G.), Tübingen; Abteilung für Neurologie (T.W.), Reha-Zentrum Bad Gögging, Passauer Wolf; Department for Neurodegenerative Diseases and Hertie Institute for Clinical Brain Research (D.W.), University of Tübingen; Division of Stereotactic and Functional Neurosurgery (M.O.P.), University Medical Center Freiburg, Germany; Departments of Functional and Stereotactic Neurosurgery and Radiosurgery (J.-.M.R.) and Neurology (T.W.), Timone University Hospital, INSERM, Marseille; Institut des Sciences Cognitives Marc Jeannerod (S.T.), CNRS, UMR 5229, Université de Lyon; Centre Expert Parkinson (S.T.), Service de Neurologie C, Hôpital Neurologique Pierre Wertheimer, Hospices Civils de Lyon, Bron; Department of Neurosurgery (P.M.), University Hospital of Neurology and Neurosurgery, Hospices Civils de Lyon, Université de Lyon; Department of Neurology (J.-L.H.), INSERM-1402, Centre Hospitalier Universitaire de Poitiers, University of Poitiers, France; and Universitätsklinikum Giessen und Marburg (L.T.), Marburg Campus, Germany.""}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Vidailhet', 'Affiliation': ""From the Département de Neurologie (W.M.M.S., A.H., T.D.H., F.P., Y.A., M.V.), Hôpital Pitié-Salpêtrière, Centre d'Investigation Clinique 1422, Institut du Cerveau et de la Moelle Epinière, Institut National de Santé et en Recherche Médicale, Assistance Publique Hôpitaux de Paris, France; Institute of Neurology (W.M.M.S.), Konolfingen; Department of Neurology (W.M.M.S.), University Hospital Bern and University of Bern, Switzerland; Medtronic (L.T.), Minneapolis, MN; Institute of Clinical Neuroscience & Medical Psychology and Department of Neurology (A.D., L.W.), Medical Faculty, Heinrich-Heine-University Düsseldorf, Germany; Movement Disorder Unit, Neurology (P.K.), CHU Grenoble Alpes; Grenoble Institut des Neurosciences (P.K., V.F., A. Kistner), University Grenoble Alpes; Inserm U1216 (P.K., V.F., A. Kistner), Grenoble, France; Department of Clinical Neurosciences (Neurology) (P.K.), Faculty of Medicine, University of Geneva, Switzerland; Coordinating Center for clinical trials of the Philipps University of Marburg (J.R., C.S.-B.); Neurochirurgische Klinik im Neurozentrum (A.F., L.P., S.P., J. Volkmann, K.K., G.D.),Christian-Albrechts-Universität Kiel; Neurologische Klinik und Poliklinik (J. Volkmann), Universitätsklinikum Würzburg; Department of Neurology (H.S.D., M.T.B., G.R.F., L.T.), University Hospital Cologne; Research Centre Jülich (G.R.F.); Klinik für Neurologie (T.D.H., A. Kühn, A. Kupsch) and Klinik für Neurochirurgie (G.-H.S.), Campus Virchow, Charité-Universitätsmedizin Berlin; Praxis Kupsch (A. Kupsch), Berlin, Germany; Service de Neurochirurgie (E.S.) and Service de Neurologie (V.F.), Hôpital Michallon, Centre Hospitalo-Universitaire, Grenoble; Departments of Neurosurgery (P.P.C.), Neurology (F.O.-M., C.B.-C.), and Clinical Pharmacology (C.B.-C.), University Hospital of Toulouse; ToNIC (F.O.-M., C.B.-C.), Toulouse Neuroimaging Center, University of Toulouse, Inserm, UPS, France; Department of Neurosurgery (J. Vesper), Universitätsklinikum Düsseldorf, Germany; Departments of Neurosurgery (S.D.) and Neurology (D.M.), Rouen University Hospital and University of Rouen; INSERM U1239 (D.M.), Laboratory of Neuronal and Neuroendocrine Differentiation and Communication, Mont-Saint-Aignan; Service de Neurologie (P. Damier, P. Derkinderen), CHU Nantes, Hôpital Laënnec, France; Paracelsus-Elena-Klinik Kassel (F.S.-D., C.T.); Department of Neurosurgery (C.T.), University Medical Center Göttingen; Division of Functional and Restorative Neurosurgery and Centre for Integrative Neuroscience (A.G.), Tübingen; Abteilung für Neurologie (T.W.), Reha-Zentrum Bad Gögging, Passauer Wolf; Department for Neurodegenerative Diseases and Hertie Institute for Clinical Brain Research (D.W.), University of Tübingen; Division of Stereotactic and Functional Neurosurgery (M.O.P.), University Medical Center Freiburg, Germany; Departments of Functional and Stereotactic Neurosurgery and Radiosurgery (J.-.M.R.) and Neurology (T.W.), Timone University Hospital, INSERM, Marseille; Institut des Sciences Cognitives Marc Jeannerod (S.T.), CNRS, UMR 5229, Université de Lyon; Centre Expert Parkinson (S.T.), Service de Neurologie C, Hôpital Neurologique Pierre Wertheimer, Hospices Civils de Lyon, Bron; Department of Neurosurgery (P.M.), University Hospital of Neurology and Neurosurgery, Hospices Civils de Lyon, Université de Lyon; Department of Neurology (J.-L.H.), INSERM-1402, Centre Hospitalier Universitaire de Poitiers, University of Poitiers, France; and Universitätsklinikum Giessen und Marburg (L.T.), Marburg Campus, Germany.""}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Timmermann', 'Affiliation': ""From the Département de Neurologie (W.M.M.S., A.H., T.D.H., F.P., Y.A., M.V.), Hôpital Pitié-Salpêtrière, Centre d'Investigation Clinique 1422, Institut du Cerveau et de la Moelle Epinière, Institut National de Santé et en Recherche Médicale, Assistance Publique Hôpitaux de Paris, France; Institute of Neurology (W.M.M.S.), Konolfingen; Department of Neurology (W.M.M.S.), University Hospital Bern and University of Bern, Switzerland; Medtronic (L.T.), Minneapolis, MN; Institute of Clinical Neuroscience & Medical Psychology and Department of Neurology (A.D., L.W.), Medical Faculty, Heinrich-Heine-University Düsseldorf, Germany; Movement Disorder Unit, Neurology (P.K.), CHU Grenoble Alpes; Grenoble Institut des Neurosciences (P.K., V.F., A. Kistner), University Grenoble Alpes; Inserm U1216 (P.K., V.F., A. Kistner), Grenoble, France; Department of Clinical Neurosciences (Neurology) (P.K.), Faculty of Medicine, University of Geneva, Switzerland; Coordinating Center for clinical trials of the Philipps University of Marburg (J.R., C.S.-B.); Neurochirurgische Klinik im Neurozentrum (A.F., L.P., S.P., J. Volkmann, K.K., G.D.),Christian-Albrechts-Universität Kiel; Neurologische Klinik und Poliklinik (J. Volkmann), Universitätsklinikum Würzburg; Department of Neurology (H.S.D., M.T.B., G.R.F., L.T.), University Hospital Cologne; Research Centre Jülich (G.R.F.); Klinik für Neurologie (T.D.H., A. Kühn, A. Kupsch) and Klinik für Neurochirurgie (G.-H.S.), Campus Virchow, Charité-Universitätsmedizin Berlin; Praxis Kupsch (A. Kupsch), Berlin, Germany; Service de Neurochirurgie (E.S.) and Service de Neurologie (V.F.), Hôpital Michallon, Centre Hospitalo-Universitaire, Grenoble; Departments of Neurosurgery (P.P.C.), Neurology (F.O.-M., C.B.-C.), and Clinical Pharmacology (C.B.-C.), University Hospital of Toulouse; ToNIC (F.O.-M., C.B.-C.), Toulouse Neuroimaging Center, University of Toulouse, Inserm, UPS, France; Department of Neurosurgery (J. Vesper), Universitätsklinikum Düsseldorf, Germany; Departments of Neurosurgery (S.D.) and Neurology (D.M.), Rouen University Hospital and University of Rouen; INSERM U1239 (D.M.), Laboratory of Neuronal and Neuroendocrine Differentiation and Communication, Mont-Saint-Aignan; Service de Neurologie (P. Damier, P. Derkinderen), CHU Nantes, Hôpital Laënnec, France; Paracelsus-Elena-Klinik Kassel (F.S.-D., C.T.); Department of Neurosurgery (C.T.), University Medical Center Göttingen; Division of Functional and Restorative Neurosurgery and Centre for Integrative Neuroscience (A.G.), Tübingen; Abteilung für Neurologie (T.W.), Reha-Zentrum Bad Gögging, Passauer Wolf; Department for Neurodegenerative Diseases and Hertie Institute for Clinical Brain Research (D.W.), University of Tübingen; Division of Stereotactic and Functional Neurosurgery (M.O.P.), University Medical Center Freiburg, Germany; Departments of Functional and Stereotactic Neurosurgery and Radiosurgery (J.-.M.R.) and Neurology (T.W.), Timone University Hospital, INSERM, Marseille; Institut des Sciences Cognitives Marc Jeannerod (S.T.), CNRS, UMR 5229, Université de Lyon; Centre Expert Parkinson (S.T.), Service de Neurologie C, Hôpital Neurologique Pierre Wertheimer, Hospices Civils de Lyon, Bron; Department of Neurosurgery (P.M.), University Hospital of Neurology and Neurosurgery, Hospices Civils de Lyon, Université de Lyon; Department of Neurology (J.-L.H.), INSERM-1402, Centre Hospitalier Universitaire de Poitiers, University of Poitiers, France; and Universitätsklinikum Giessen und Marburg (L.T.), Marburg Campus, Germany.""}, {'ForeName': 'Günther', 'Initials': 'G', 'LastName': 'Deuschl', 'Affiliation': ""From the Département de Neurologie (W.M.M.S., A.H., T.D.H., F.P., Y.A., M.V.), Hôpital Pitié-Salpêtrière, Centre d'Investigation Clinique 1422, Institut du Cerveau et de la Moelle Epinière, Institut National de Santé et en Recherche Médicale, Assistance Publique Hôpitaux de Paris, France; Institute of Neurology (W.M.M.S.), Konolfingen; Department of Neurology (W.M.M.S.), University Hospital Bern and University of Bern, Switzerland; Medtronic (L.T.), Minneapolis, MN; Institute of Clinical Neuroscience & Medical Psychology and Department of Neurology (A.D., L.W.), Medical Faculty, Heinrich-Heine-University Düsseldorf, Germany; Movement Disorder Unit, Neurology (P.K.), CHU Grenoble Alpes; Grenoble Institut des Neurosciences (P.K., V.F., A. Kistner), University Grenoble Alpes; Inserm U1216 (P.K., V.F., A. Kistner), Grenoble, France; Department of Clinical Neurosciences (Neurology) (P.K.), Faculty of Medicine, University of Geneva, Switzerland; Coordinating Center for clinical trials of the Philipps University of Marburg (J.R., C.S.-B.); Neurochirurgische Klinik im Neurozentrum (A.F., L.P., S.P., J. Volkmann, K.K., G.D.),Christian-Albrechts-Universität Kiel; Neurologische Klinik und Poliklinik (J. Volkmann), Universitätsklinikum Würzburg; Department of Neurology (H.S.D., M.T.B., G.R.F., L.T.), University Hospital Cologne; Research Centre Jülich (G.R.F.); Klinik für Neurologie (T.D.H., A. Kühn, A. Kupsch) and Klinik für Neurochirurgie (G.-H.S.), Campus Virchow, Charité-Universitätsmedizin Berlin; Praxis Kupsch (A. Kupsch), Berlin, Germany; Service de Neurochirurgie (E.S.) and Service de Neurologie (V.F.), Hôpital Michallon, Centre Hospitalo-Universitaire, Grenoble; Departments of Neurosurgery (P.P.C.), Neurology (F.O.-M., C.B.-C.), and Clinical Pharmacology (C.B.-C.), University Hospital of Toulouse; ToNIC (F.O.-M., C.B.-C.), Toulouse Neuroimaging Center, University of Toulouse, Inserm, UPS, France; Department of Neurosurgery (J. Vesper), Universitätsklinikum Düsseldorf, Germany; Departments of Neurosurgery (S.D.) and Neurology (D.M.), Rouen University Hospital and University of Rouen; INSERM U1239 (D.M.), Laboratory of Neuronal and Neuroendocrine Differentiation and Communication, Mont-Saint-Aignan; Service de Neurologie (P. Damier, P. Derkinderen), CHU Nantes, Hôpital Laënnec, France; Paracelsus-Elena-Klinik Kassel (F.S.-D., C.T.); Department of Neurosurgery (C.T.), University Medical Center Göttingen; Division of Functional and Restorative Neurosurgery and Centre for Integrative Neuroscience (A.G.), Tübingen; Abteilung für Neurologie (T.W.), Reha-Zentrum Bad Gögging, Passauer Wolf; Department for Neurodegenerative Diseases and Hertie Institute for Clinical Brain Research (D.W.), University of Tübingen; Division of Stereotactic and Functional Neurosurgery (M.O.P.), University Medical Center Freiburg, Germany; Departments of Functional and Stereotactic Neurosurgery and Radiosurgery (J.-.M.R.) and Neurology (T.W.), Timone University Hospital, INSERM, Marseille; Institut des Sciences Cognitives Marc Jeannerod (S.T.), CNRS, UMR 5229, Université de Lyon; Centre Expert Parkinson (S.T.), Service de Neurologie C, Hôpital Neurologique Pierre Wertheimer, Hospices Civils de Lyon, Bron; Department of Neurosurgery (P.M.), University Hospital of Neurology and Neurosurgery, Hospices Civils de Lyon, Université de Lyon; Department of Neurology (J.-L.H.), INSERM-1402, Centre Hospitalier Universitaire de Poitiers, University of Poitiers, France; and Universitätsklinikum Giessen und Marburg (L.T.), Marburg Campus, Germany. g.deuschl@neurologie.uni-kiel.de.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Neurology,['10.1212/WNL.0000000000007037'] 741,32144133,Randomized Phase II Trial Evaluating Treatment with EGFR-TKI Associated with Antiestrogen in Women with Nonsquamous Advanced-Stage NSCLC: IFCT-1003 LADIE Trial.,"PURPOSE The incidence of lung cancer has dramatically increased in women. Preclinical data have suggested that combining EGFR-tyrosine kinase inhibitor (TKI) with an antiestrogen may overcome resistance to EGFR-TKI. PATIENTS AND METHODS The IFCT-1003 LADIE trial was a 2 × 2 arms parallel open-label randomized phase II trial. EGFR-TKI-naïve postmenopausal women with advanced lung cancer were treated with gefitinib (G) versus gefitinib + fulvestrant (G+F) in the EGFR-mutated group (EGFR + ) or with erlotinib (E) versus erlotinib + fulvestrant (E+F) in the EGFR wild-type group (EGFR-WT). The primary objective was progression-free survival (PFS) at 3 and 9 months for EGFR-WT and EGFR + patients. RESULTS Overall, 204 patients (gefitinib 104 and G+F 100) and 175 patients (erlotinib 87 and E+F 88) were enrolled in the EGFR + and EGFR-WT cohorts. In the EGFR + cohort, the primary endpoint was reached, with 58% of the G+F group patients being nonprogressive at 9 months. Adding fulvestrant to gefitinib was not associated with improved PFS (9.9 vs 9.4 months) or overall survival (OS; 22.1 vs 28.6 months). In the EGFR-WT cohort, the primary endpoint was also achieved (33.7% of the patients were nonprogressive at 3 months). Adding fulvestrant to erlotinib was not associated with improved outcome (PFS 1.8 vs 2.0 and OS 10.3 vs 7.3 months). No PFS difference was observed regarding estrogen receptor alpha expression. The tolerance was as expected with no treatment-related death. CONCLUSIONS Adding fulvestrant to EGFR-TKI is feasible, but not associated with prolonged PFS regardless of EGFR status. The lack of benefits while combining fulvestrant to EGFR-TKI does not support its future development in an unselected population.",2020,Adding F to G was not associated with improved PFS (9.9 vs 9.4 months) or OS (22.1 vs 28.6 months).,"['women with non-squamous advanced stage NSCLC', 'women', '204 patients and 175 patients were enrolled in the EGFR+ and EGFR-WT cohorts', 'EGFR-TKI-naïve post-menopausal women with advanced lung cancer']","['EGFR mutated group (EGFR+) or with erlotinib (E) vs. E + fulvestrant (E+F', 'gefitinib (G) vs. G + fulvestrant (G+F', 'G+F', 'EGFR-TKI associated with anti-estrogen']","['progression-free survival (PFS', 'PFS', 'Estrogen Receptor alpha expression']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4517605', 'cui_str': '175'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0025320', 'cui_str': 'Change of Life, Female'}, {'cui': 'C4524268', 'cui_str': 'Advanced lung cancer'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1135135', 'cui_str': 'erlotinib'}, {'cui': 'C0935916', 'cui_str': 'fulvestrant'}, {'cui': 'C1122962', 'cui_str': 'gefitinib'}, {'cui': 'C0332281', 'cui_str': 'Associated with (attribute)'}, {'cui': 'C0014930', 'cui_str': 'Estrogen Antagonists'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0665341', 'cui_str': 'Estrogen Receptor alpha'}, {'cui': 'C3854321', 'cui_str': 'Expression'}]",204.0,0.0564342,Adding F to G was not associated with improved PFS (9.9 vs 9.4 months) or OS (22.1 vs 28.6 months).,"[{'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Mazieres', 'Affiliation': 'Service de Pneumologie, Hôpital Larrey, Centre Hospitalier Universitaire Toulouse, Toulouse, France. mazieres.j@chu-toulouse.fr.'}, {'ForeName': 'Fabrice', 'Initials': 'F', 'LastName': 'Barlesi', 'Affiliation': 'Intergroupe Francophone de Cancérologie Thoracique (IFCT), Paris, France.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Rouquette', 'Affiliation': ""Service d'Anatomopathologie, Centre Hospitalier Universitaire Toulouse, Toulouse, France.""}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Molinier', 'Affiliation': 'Intergroupe Francophone de Cancérologie Thoracique (IFCT), Paris, France.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Besse', 'Affiliation': 'Intergroupe Francophone de Cancérologie Thoracique (IFCT), Paris, France.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Monnet', 'Affiliation': 'Intergroupe Francophone de Cancérologie Thoracique (IFCT), Paris, France.'}, {'ForeName': 'Clarisse', 'Initials': 'C', 'LastName': 'Audigier-Valette', 'Affiliation': 'Intergroupe Francophone de Cancérologie Thoracique (IFCT), Paris, France.'}, {'ForeName': 'Anne-Claire', 'Initials': 'AC', 'LastName': 'Toffart', 'Affiliation': 'Intergroupe Francophone de Cancérologie Thoracique (IFCT), Paris, France.'}, {'ForeName': 'Patrick Aldo', 'Initials': 'PA', 'LastName': 'Renault', 'Affiliation': 'Intergroupe Francophone de Cancérologie Thoracique (IFCT), Paris, France.'}, {'ForeName': 'Séverine', 'Initials': 'S', 'LastName': 'Fraboulet', 'Affiliation': 'Intergroupe Francophone de Cancérologie Thoracique (IFCT), Paris, France.'}, {'ForeName': 'Sandrine', 'Initials': 'S', 'LastName': 'Hiret', 'Affiliation': 'Intergroupe Francophone de Cancérologie Thoracique (IFCT), Paris, France.'}, {'ForeName': 'Bertrand', 'Initials': 'B', 'LastName': 'Mennecier', 'Affiliation': 'Intergroupe Francophone de Cancérologie Thoracique (IFCT), Paris, France.'}, {'ForeName': 'Didier', 'Initials': 'D', 'LastName': 'Debieuvre', 'Affiliation': 'Intergroupe Francophone de Cancérologie Thoracique (IFCT), Paris, France.'}, {'ForeName': 'Virginie', 'Initials': 'V', 'LastName': 'Westeel', 'Affiliation': 'Intergroupe Francophone de Cancérologie Thoracique (IFCT), Paris, France.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Masson', 'Affiliation': 'Intergroupe Francophone de Cancérologie Thoracique (IFCT), Paris, France.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Madroszyk-Flandin', 'Affiliation': 'Intergroupe Francophone de Cancérologie Thoracique (IFCT), Paris, France.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Pichon', 'Affiliation': 'Intergroupe Francophone de Cancérologie Thoracique (IFCT), Paris, France.'}, {'ForeName': 'Alexis B', 'Initials': 'AB', 'LastName': 'Cortot', 'Affiliation': 'Intergroupe Francophone de Cancérologie Thoracique (IFCT), Paris, France.'}, {'ForeName': 'Elodie', 'Initials': 'E', 'LastName': 'Amour', 'Affiliation': 'Intergroupe Francophone de Cancérologie Thoracique (IFCT), Paris, France.'}, {'ForeName': 'Franck', 'Initials': 'F', 'LastName': 'Morin', 'Affiliation': 'Intergroupe Francophone de Cancérologie Thoracique (IFCT), Paris, France.'}, {'ForeName': 'Gérard', 'Initials': 'G', 'LastName': 'Zalcman', 'Affiliation': 'Intergroupe Francophone de Cancérologie Thoracique (IFCT), Paris, France.'}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Moro-Sibilot', 'Affiliation': 'Intergroupe Francophone de Cancérologie Thoracique (IFCT), Paris, France.'}, {'ForeName': 'Pierre-Jean', 'Initials': 'PJ', 'LastName': 'Souquet', 'Affiliation': 'Intergroupe Francophone de Cancérologie Thoracique (IFCT), Paris, France.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-19-3056'] 742,29874567,Intermittent Fasting Confers Protection in CNS Autoimmunity by Altering the Gut Microbiota.,"Multiple sclerosis (MS) is more common in western countries with diet being a potential contributing factor. Here we show that intermittent fasting (IF) ameliorated clinical course and pathology of the MS model, experimental autoimmune encephalomyelitis (EAE). IF led to increased gut bacteria richness, enrichment of the Lactobacillaceae, Bacteroidaceae, and Prevotellaceae families and enhanced antioxidative microbial metabolic pathways. IF altered T cells in the gut with a reduction of IL-17 producing T cells and an increase in regulatory T cells. Fecal microbiome transplantation from mice on IF ameliorated EAE in immunized recipient mice on a normal diet, suggesting that IF effects are at least partially mediated by the gut flora. In a pilot clinical trial in MS patients, intermittent energy restriction altered blood adipokines and the gut flora resembling protective changes observed in mice. In conclusion, IF has potent immunomodulatory effects that are at least partially mediated by the gut microbiome.",2018,IF altered T cells in the gut with a reduction of IL-17 producing T cells and an increase in regulatory T cells.,[],[],"['gut bacteria richness, enrichment of the Lactobacillaceae, Bacteroidaceae, and Prevotellaceae families and enhanced antioxidative microbial metabolic pathways', 'regulatory T\xa0cells']",[],[],"[{'cui': 'C1510439', 'cui_str': 'bacteria'}, {'cui': 'C0022937', 'cui_str': 'Lactobacillaceae'}, {'cui': 'C0004660', 'cui_str': 'Bacteroidaceae'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C1291081', 'cui_str': 'Metabolic Pathway'}, {'cui': 'C0039198', 'cui_str': 'T-Cells, Regulatory'}]",,0.0336229,IF altered T cells in the gut with a reduction of IL-17 producing T cells and an increase in regulatory T cells.,"[{'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Cignarella', 'Affiliation': 'Department of Neurology, Washington University School of Medicine, Campus Box 8111, 660 S. Euclid Avenue, St. Louis, MO 63110, USA.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Cantoni', 'Affiliation': 'Department of Neurology, Washington University School of Medicine, Campus Box 8111, 660 S. Euclid Avenue, St. Louis, MO 63110, USA.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Ghezzi', 'Affiliation': 'Department of Neurology, Washington University School of Medicine, Campus Box 8111, 660 S. Euclid Avenue, St. Louis, MO 63110, USA; Neurology Unit, Department of Pathophysiology and Transplantation, University of Milan, Fondazione Cà Granda, IRCCS Ospedale Policlinico, Milan, Italy.'}, {'ForeName': 'Amber', 'Initials': 'A', 'LastName': 'Salter', 'Affiliation': 'Division of Biostatistics, Washington University School of Medicine, St. Louis, MO 63110, USA.'}, {'ForeName': 'Yair', 'Initials': 'Y', 'LastName': 'Dorsett', 'Affiliation': 'Jackson Laboratory for Genomic Medicine, Farmington, CT, USA.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Jackson Laboratory for Genomic Medicine, Farmington, CT, USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Phillips', 'Affiliation': 'Jackson Laboratory for Genomic Medicine, Farmington, CT, USA.'}, {'ForeName': 'George M', 'Initials': 'GM', 'LastName': 'Weinstock', 'Affiliation': 'Jackson Laboratory for Genomic Medicine, Farmington, CT, USA.'}, {'ForeName': 'Luigi', 'Initials': 'L', 'LastName': 'Fontana', 'Affiliation': 'Department of Medicine, Washington University School of Medicine, St. Louis, MO 63110, USA; Department of Clinical and Experimental Sciences, Brescia University Medical School, Brescia, Italy; CEINGE Biotecnologie Avanzate, Napoli, Italy.'}, {'ForeName': 'Anne H', 'Initials': 'AH', 'LastName': 'Cross', 'Affiliation': 'Department of Neurology, Washington University School of Medicine, Campus Box 8111, 660 S. Euclid Avenue, St. Louis, MO 63110, USA; Hope Center for Neurological Disorders, Washington University School of Medicine, St Louis, MO, USA.'}, {'ForeName': 'Yanjiao', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'Jackson Laboratory for Genomic Medicine, Farmington, CT, USA. Electronic address: yazhou@uchc.edu.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Piccio', 'Affiliation': 'Department of Neurology, Washington University School of Medicine, Campus Box 8111, 660 S. Euclid Avenue, St. Louis, MO 63110, USA; Hope Center for Neurological Disorders, Washington University School of Medicine, St Louis, MO, USA. Electronic address: picciol@wustl.edu.'}]",Cell metabolism,['10.1016/j.cmet.2018.05.006'] 743,32144829,Effect of preoperative pelvic floor muscle training on pelvic floor muscle contraction and symptomatic and anatomical pelvic organ prolapse after surgery: randomized controlled trial.,"OBJECTIVES To evaluate the effect of preoperative pelvic floor muscle training (PFMT) on pelvic floor muscle (PFM) contraction, symptoms of pelvic organ prolapse (POP) and anatomical POP, 6 months after prolapse surgery, and to assess the overall changes in PFM contraction, POP symptoms and pelvic organ descent after surgery. METHODS This was a randomized controlled trial of 159 women with symptomatic POP, Stage 2 or higher, scheduled for surgery. Participants were randomized to intervention including daily PFMT from inclusion to surgery (n = 81) or no intervention (controls; n = 78). Participants were examined at inclusion, on the day of surgery and 6 months after surgery. PFM contraction was assessed by: vaginal palpation using the Modified Oxford scale (MOS; 0-5); transperineal ultrasound, measuring the percentage change in levator hiatal anteroposterior diameter (APD) from rest to maximum PFM contraction; vaginal manometry; and surface electromyography (EMG). POP distance from the hymen in the compartment with the most dominant prolapse and organ descent in the anterior, central and posterior compartments were measured on maximum Valsalva maneuver. POP symptoms were assessed based on the sensation of vaginal bulge, which was graded using a visual analog scale (VAS; 0-100 mm). Linear mixed models were used to assess the effect of PFMT on outcome variables. RESULTS Of the 159 women randomized, 151 completed the study, comprising 75 in the intervention and 76 in the control group. Mean waiting time for surgery was 22 ± 9.7 weeks and follow-up was performed on average 28 ± 7.8 weeks after surgery. Postoperatively, no difference was found between the intervention and control groups with respect to PFM contraction assessed by vaginal palpation (MOS, 2.4 vs 2.2; P = 0.101), manometry (19.4 vs 19.7 cmH 2 O; P = 0.793), surface EMG (33.5 vs 33.1 mV; P = 0.815) and ultrasound (change in hiatal APD, 20.9% vs 19.3%; P = 0.211). Furthermore, no difference between groups was found for sensation of vaginal bulge (VAS, 7.4 vs 6.0 mm; P = 0.598), POP distance from the hymen in the dominant prolapse compartment (-1.8 vs -2.0 cm; P = 0.556) and sonographic descent of the bladder (0.5 vs 0.8 cm; P = 0.058), cervix (-1.3 vs -1.1 cm; P = 0.569) and rectal ampulla (0.3 vs 0.4 cm; P = 0.434). In all patients, compared with findings at initial examination, muscle contraction improved after surgery, as assessed by palpation (MOS, 2.1 vs 2.3; P = 0.007) and ultrasound (change in hiatal APD, 17.5% vs 20.1%; P = 0.001), and sensation of vaginal bulge was reduced (VAS, 57.6 vs 6.7 mm; P < 0.001). In addition, compared with the baseline examination, POP distance from the hymen in the dominant prolapse compartment (1.9 vs -1.9 cm; P < 0.001) and sonographic descent of the bladder (1.3 vs 0.6 cm; P < 0.001), cervix (0.0 vs -1.2 cm; P < 0.001) and rectal ampulla (0.9 vs 0.4 cm; P = 0.001) were reduced. CONCLUSIONS We found no effect of preoperative PFMT on PFM contraction, POP symptoms or anatomical prolapse after surgery. In all patients, PFM contraction and POP symptoms were improved at the 6-month follow-up, most likely due to the anatomical correction of POP. Copyright © 2020 ISUOG. Published by John Wiley & Sons Ltd.",2020,"Overall, contraction improved after surgery: palpation (MOS) 2.1 vs 2.3, p = 0.007 and ultrasound (% change) 17.5 vs 20.1, p = 0.001.","['Women scheduled for POP surgery (n=159', '151 women completed the study', 'pelvic floor contraction, symptomatic and anatomical pelvic organ prolapse after surgery']","['preoperative PFMT', 'preoperative pelvic floor muscle training (PFMT', 'preoperative pelvic floor muscle training', 'intervention including daily PFMT from inclusion to surgery (n=\u200981) or control']","['pelvic floor contraction, symptoms and anatomical pelvic organ prolapse (POP', 'Mean waiting time', 'POP distance', 'Pelvic floor muscle contraction', 'Sensation of vaginal bulge', 'contraction, symptomatic or anatomical prolapse', 'visual analogue scale (VAS']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0439820', 'cui_str': 'Popping sensation quality'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0206248', 'cui_str': 'Pelvic Diaphragm'}, {'cui': 'C1140999', 'cui_str': 'Contraction (finding)'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0220784', 'cui_str': 'Anatomic (qualifier value)'}, {'cui': 'C0877015', 'cui_str': 'Urogenital Prolapse'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C4087139', 'cui_str': 'Pelvic floor muscle training'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0206248', 'cui_str': 'Pelvic Diaphragm'}, {'cui': 'C1140999', 'cui_str': 'Contraction (finding)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0220784', 'cui_str': 'Anatomic (qualifier value)'}, {'cui': 'C0877015', 'cui_str': 'Urogenital Prolapse'}, {'cui': 'C0439820', 'cui_str': 'Popping sensation quality'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C0026820', 'cui_str': 'Muscular Contraction'}, {'cui': 'C0036658', 'cui_str': 'Sensory Function'}, {'cui': 'C4521343', 'cui_str': 'Vaginal (intended site)'}, {'cui': 'C0038999', 'cui_str': 'Bulging (morphologic abnormality)'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0033377', 'cui_str': 'Prolapse'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}]",159.0,0.0867496,"Overall, contraction improved after surgery: palpation (MOS) 2.1 vs 2.3, p = 0.007 and ultrasound (% change) 17.5 vs 20.1, p = 0.001.","[{'ForeName': 'M Ø', 'Initials': 'MØ', 'LastName': 'Nyhus', 'Affiliation': ""Department of Obstetrics and Gynecology, St Olav's Hospital, Trondheim University Hospital, Trondheim, Norway.""}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Mathew', 'Affiliation': ""Department of Obstetrics and Gynecology, St Olav's Hospital, Trondheim University Hospital, Trondheim, Norway.""}, {'ForeName': 'Ø', 'Initials': 'Ø', 'LastName': 'Salvesen', 'Affiliation': 'Department of Public Health and Nursing, Norwegian University of Science and Technology, Trondheim, Norway.'}, {'ForeName': 'K Å', 'Initials': 'KÅ', 'LastName': 'Salvesen', 'Affiliation': ""Department of Obstetrics and Gynecology, St Olav's Hospital, Trondheim University Hospital, Trondheim, Norway.""}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Stafne', 'Affiliation': 'Department of Public Health and Nursing, Norwegian University of Science and Technology, Trondheim, Norway.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Volløyhaug', 'Affiliation': ""Department of Obstetrics and Gynecology, St Olav's Hospital, Trondheim University Hospital, Trondheim, Norway.""}]",Ultrasound in obstetrics & gynecology : the official journal of the International Society of Ultrasound in Obstetrics and Gynecology,['10.1002/uog.22007'] 744,29985095,Impact of mindfulness-based stress reduction for people with multiple sclerosis at 8 weeks and 12 months: A randomized clinical trial.,"BACKGROUND Mindfulness training is often used as a therapeutic intervention to manage stress and enhance emotional well-being, yet trials for multiple sclerosis (MS) are limited and few have used an active control. OBJECTIVE Assess the feasibility of mindfulness-based stress reduction (MBSR) for people with MS and evaluate the efficacy of MBSR compared to an education control. METHODS We conducted a single-blind, randomized trial of MBSR versus education control among 62 adults with MS. Primary outcomes were measures of feasibility. Secondary outcomes included perceived stress, anxiety, depression, fatigue, pain, resilience, and the Paced Auditory Serial Addition Test, assessed at baseline, 8 weeks, and 12 months. Mean scores for secondary outcome measures were compared between groups at each time point and within groups across time by analyses of covariance or paired t -tests, respectively. RESULTS Successful recruitment and retention demonstrated feasibility. Improvements in several secondary outcomes were observed among both MBSR and control groups. However, differences between the groups were not statistically significant at either 8 weeks or 12 months. CONCLUSION Emotional well-being improved with both MBSR and education. Spontaneous improvement cannot be ruled out as an explanation for findings and additional studies that evaluate the impact of mindfulness training to improve emotional health are warranted.",2019,"Secondary outcomes included perceived stress, anxiety, depression, fatigue, pain, resilience, and the Paced Auditory Serial Addition Test, assessed at baseline, 8 weeks, and 12 months.","['people with multiple sclerosis at 8\u2009weeks and 12\u2009months', '62 adults with MS', 'people with MS']","['MBSR', 'mindfulness-based stress reduction', 'mindfulness-based stress reduction (MBSR']","['perceived stress, anxiety, depression, fatigue, pain, resilience, and the Paced Auditory Serial Addition Test', 'Emotional well-being improved with both MBSR and education', 'Mean scores']","[{'cui': 'C0026769', 'cui_str': 'MS (Multiple Sclerosis)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}]","[{'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0589060', 'cui_str': 'Paced Auditory Serial Addition Test'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",62.0,0.101027,"Secondary outcomes included perceived stress, anxiety, depression, fatigue, pain, resilience, and the Paced Auditory Serial Addition Test, assessed at baseline, 8 weeks, and 12 months.","[{'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Senders', 'Affiliation': 'Helfgott Research Institute, National University of Natural Medicine, Portland, OR, USA/Department of Neurology, Oregon Health & Science University, Portland, OR, USA/OHSU-PSU School of Public Health, Portland, OR, USA.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Hanes', 'Affiliation': 'Helfgott Research Institute, National University of Natural Medicine, Portland, OR, USA.'}, {'ForeName': 'Dennis', 'Initials': 'D', 'LastName': 'Bourdette', 'Affiliation': 'Department of Neurology, Oregon Health & Science University, Portland, OR, USA.'}, {'ForeName': 'Kimberly', 'Initials': 'K', 'LastName': 'Carson', 'Affiliation': 'Department of Anesthesiology & Perioperative Medicine, Oregon Health & Science University, Portland, OR, USA.'}, {'ForeName': 'Lynn M', 'Initials': 'LM', 'LastName': 'Marshall', 'Affiliation': 'Department of Orthopedics and Rehabilitation, Oregon Health & Science University, Portland, OR, USA/OHSU-PSU School of Public Health, Portland, OR, USA.'}, {'ForeName': 'Lynne', 'Initials': 'L', 'LastName': 'Shinto', 'Affiliation': 'Department of Neurology, Oregon Health & Science University, Portland, OR, USA.'}]","Multiple sclerosis (Houndmills, Basingstoke, England)",['10.1177/1352458518786650'] 745,29790196,Rituximab Is Ineffective for Treatment of Fatigue in Primary Biliary Cholangitis: A Phase 2 Randomized Controlled Trial.,"Primary biliary cholangitis (PBC) is a chronic cholestatic liver disease. Half of patients experience debilitating fatigue, which is currently untreatable. Previous studies have shown muscle bioenergetic abnormalities in PBC, including increased muscle acidosis with exercise linked to the antimitochondrial antibody (AMA) diagnostic of the disease, and reduced anaerobic threshold. In this study we addressed the hypothesis that fatigue in PBC is driven by muscle bioenergetic abnormality related to AMA, and that AMA reduction with B-cell depletion therapy will improve fatigue. In our single-center phase 2 randomized controlled trial, 57 participants aged 18 years or older with PBC and moderate to severe fatigue were randomized to receive two doses of either rituximab (1000 mg) or saline (placebo). The primary outcome measure was fatigue severity assessed using the PBC-40 fatigue domain at 3 months. Secondary outcome measures included patient-reported outcomes and immunological and bioenergetics disease parameters. Experimental outcomes included biochemical markers of disease severity. Improvement in fatigue score at 3 months was seen in both arms, with no significant difference (adjusted mean difference -0.9 [95% confidence interval -4.6 to 3.1]). Little difference was observed in other patient-reported outcomes or physical activity. Significant anaerobic threshold improvement was seen in the rituximab group, only but this was not associated with fatigue improvement. No treatment-emergent serious adverse events were seen. Conclusions: Rituximab was safe over the 12-month study period but showed no evidence of effectiveness for the treatment of fatigue in PBC. Anaerobic threshold improvement was seen, potentially linking AMA with muscle bioenergetics dysfunction; however, this was not related to improvement in fatigue. Rituximab had some evidence of a beneficial effect on alkaline phosphatase levels in this largely ursodeoxycholic acid (UDCA)-responding, early-disease stage cohort. (Hepatology 2018; 00:000-000).",2019,"Improvement in fatigue score at 3 months was seen in both arms, with no significant difference (adjusted mean difference -0.9","['57 participants aged 18 years or older with PBC and moderate to severe fatigue', 'Primary Biliary Cholangitis']","['ursodeoxycholic acid', 'Rituximab', 'rituximab (1000 mg) or saline (placebo']","['fatigue', 'biochemical markers of disease severity', 'fatigue improvement', 'fatigue severity assessed using the PBC-40 fatigue domain', 'patient-reported outcomes and immunological and bioenergetics disease parameters', 'Significant anaerobic threshold improvement', 'alkaline phosphatase levels', 'Primary biliary cholangitis (PBC', 'fatigue score']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0008312', 'cui_str': 'Primary Billiary Cholangitis'}]","[{'cui': 'C0042105', 'cui_str': 'ursodesoxycholic acid'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C1883310', 'cui_str': '1000 (qualifier value)'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0206015', 'cui_str': 'Biochemical Marker'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0205470', 'cui_str': 'Immunologic (qualifier value)'}, {'cui': 'C0005486', 'cui_str': 'Bioenergetics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0002749', 'cui_str': 'Anaerobic Threshold'}, {'cui': 'C0428332', 'cui_str': 'Alkaline phosphatase level - finding'}, {'cui': 'C0008312', 'cui_str': 'Primary Billiary Cholangitis'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",57.0,0.333394,"Improvement in fatigue score at 3 months was seen in both arms, with no significant difference (adjusted mean difference -0.9","[{'ForeName': 'Amardeep', 'Initials': 'A', 'LastName': 'Khanna', 'Affiliation': 'Institute of Cellular Medicine, Newcastle University, Newcastle upon Tyne, United Kingdom.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Jopson', 'Affiliation': 'Institute of Cellular Medicine, Newcastle University, Newcastle upon Tyne, United Kingdom.'}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Howel', 'Affiliation': 'Institute of Health & Society, Newcastle University, Newcastle upon Tyne, United Kingdom.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Bryant', 'Affiliation': 'Institute of Health & Society, Newcastle University, Newcastle upon Tyne, United Kingdom.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Blamire', 'Affiliation': 'Institute of Cellular Medicine, Newcastle University, Newcastle upon Tyne, United Kingdom.'}, {'ForeName': 'Julia L', 'Initials': 'JL', 'LastName': 'Newton', 'Affiliation': 'Institute of Cellular Medicine, Newcastle University, Newcastle upon Tyne, United Kingdom.'}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Jones', 'Affiliation': 'Institute of Cellular Medicine, Newcastle University, Newcastle upon Tyne, United Kingdom.'}]","Hepatology (Baltimore, Md.)",['10.1002/hep.30099'] 746,32144531,Conservative Sinusectomy vs. excision and primary off-midline closure for pilonidal disease: a randomized controlled trial.,"PURPOSE Pilonidal sinus disease (PD) is a common acquired disease, responsible for discomfort and time off work. There is currently no consensus on the best surgical therapy. We aimed at comparing conservative sinusectomy (S) to excision and paramedian primary closure (PC). METHODS This is a randomized controlled trial compatible with the CONSORT statement standards. We included all patients with chronic PD between 2012 and 2017. We excluded patients with acute abscesses, recurrent PD after surgery with a curative intent and patients needing complex reconstructions with rotation flaps. Patients with chronic symptomatic PD were randomized to S or PC. Primary end-point was the rate of patients healed at 3 weeks, secondary outcomes were total healing time, pain, time off work, patient satisfaction and recurrence at 1 year. Patients were seen at a wound clinic until healed and contacted at 3, 6, and 12 months for follow-up. RESULTS After inclusion of 58 patients the study was stopped prematurely due to discrepancy between expected and observed outcomes. Only 4/30 (13.3%) patients in the S group had healed completely at 3 weeks compared with 14/28 (50%) in the PC group (p = 0.01). Median time to complete healing was 54 (23-328) days in the S group compared to 34 (13-141) in the PC group (p = 0.025). Number of outpatient visits, time off work, analgesia requirement, and recurrence rates at 12 months 4 (16%) in the S group and 3 (11.1%) in the PC group (p = 0.548) were similar. CONCLUSIONS PC leads to faster healing compared to S, with similar healthcare burden. TRIAL REGISTRATION The study was approved by the local ethics committee and registered in www.clinicaltrials.gov (REF: NCT03271996). The study was carried out at the Regional Hospital of Lugano, Switzerland.",2020,Only 4/30 (13.3%) patients in the S group had healed completely at 3 weeks compared with 14/28 (50%) in the PC group (p = 0.01).,"['patients with acute abscesses, recurrent PD after surgery with a curative intent and patients needing complex reconstructions with rotation flaps', 'patients with chronic PD between 2012 and 2017', 'pilonidal disease', 'Patients with chronic symptomatic PD']","['Conservative Sinusectomy vs. excision and primary off-midline closure', 'conservative sinusectomy (S) to excision and paramedian primary closure (PC']","['total healing time, pain, time off work, patient satisfaction and recurrence at 1\xa0year', 'Median time to complete healing', 'Number of outpatient visits, time off work, analgesia requirement, and recurrence rates', 'rate of patients healed']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001304', 'cui_str': 'Acute abscess (morphologic abnormality)'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C1276305', 'cui_str': 'Curative procedure'}, {'cui': 'C1283828', 'cui_str': 'Intentional'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}, {'cui': 'C0439855', 'cui_str': 'Complex (qualifier value)'}, {'cui': 'C0524865', 'cui_str': 'Reconstructive Surgery'}, {'cui': 'C4544575', 'cui_str': 'Rotation flap (substance)'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C2317114', 'cui_str': 'Pilonidal disease'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}]","[{'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0185003', 'cui_str': 'Reparative closure (procedure)'}, {'cui': 'C0441993', 'cui_str': 'Paramedian approach (qualifier value)'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0043240', 'cui_str': 'Wound Healing'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0585074', 'cui_str': 'Amount of time off work'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205249', 'cui_str': 'Healed (qualifier value)'}]",,0.118992,Only 4/30 (13.3%) patients in the S group had healed completely at 3 weeks compared with 14/28 (50%) in the PC group (p = 0.01).,"[{'ForeName': 'Sotirios Georgios', 'Initials': 'SG', 'LastName': 'Popeskou', 'Affiliation': 'Department of Visceral Surgery and Transplantation, Geneva University Hospitals, Geneva, Switzerland. salvator10@yahoo.com.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Pravini', 'Affiliation': 'Depatment of Surgery, Regional Hospital of Lugano, Lugano, Switzerland.'}, {'ForeName': 'Sofoklis', 'Initials': 'S', 'LastName': 'Panteleimonitis', 'Affiliation': 'School of Health Sciences and social work, University of Portsmouth, Portsmouth, UK.'}, {'ForeName': 'Antoniacopo Ferrario Di Tor', 'Initials': 'AFDT', 'LastName': 'Vajana', 'Affiliation': 'Department of Surgery, Regional Hospital of Bellinzona, Bellinzona, Switzerland.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Vanoni', 'Affiliation': 'Department of Visceral Surgery, Lausanne University Hospital, Lausanne, Switzerland.'}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Schmalzbauer', 'Affiliation': 'Depatment of Surgery, Regional Hospital of Lugano, Lugano, Switzerland.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Posabella', 'Affiliation': 'Department of Surgery, Standort Unispital Clarunis, Universitäres Bauchzentrum Basel, Basel, Switzerland.'}, {'ForeName': 'Dimitri', 'Initials': 'D', 'LastName': 'Christoforidis', 'Affiliation': 'Department of Surgery, Regional Hospital of Lugano, Lugano, Switzerland.'}]",International journal of colorectal disease,['10.1007/s00384-020-03551-9'] 747,29955866,Reasons for Opioid Discontinuation and Unintended Consequences Following Opioid Discontinuation Within the TOPCARE Trial.,"OBJECTIVE To identify reasons for opioid discontinuation and post-discontinuation outcomes among patients in the Transforming Opioid Prescribing in Primary Care (TOPCARE) study. DESIGN In TOPCARE, an intervention to improve adherence to opioid prescribing guidelines, randomized intervention primary care providers (PCPs) received nurse care manager support, an electronic registry, academic detailing, and electronic tools, and control PCPs received electronic tools only. SETTING Four Boston safety net primary care practices. SUBJECTS Patients in both TOPCARE study arms who discontinued opioid therapy during the trial. METHODS Through chart review, we examined the reason for discontinuation and post-discontinuation outcomes: one or more PCP visits, one or more pain-related emergency department (ED) visits, evidence of opioid use disorder (OUD), and referral for OUD treatment. RESULTS Opioid discontinuations occurred in 83/586 (14.2%) intervention and 42/399 (10.5%) control patients (P = 0.09). Among patients who discontinued opioids, 81 (65%) discontinued for misuse, with no difference by group (P = 0.38). Aberrancy in monitoring (e.g., discordant urine drug test results) was the most common type of misuse prompting discontinuation (occurring in (51/83 [61%] of intervention patients vs 19/42 [45%, P = 0.08] of control patients). Intervention patients who discontinued opioids had less PCP follow-up (65% vs 88%, P < 0.01) compared with control patients. We found no differences between groups for pain-related ED visits, evidence of OUD, or OUD treatment referral following discontinuation. CONCLUSIONS The decreased follow-up among TOPCARE intervention patients who discontinued opioids highlights the need to understand unintended consequences of involuntary opioid discontinuations resulting from interventions to reduce opioid risk.",2019,"We found no differences between groups for pain-related ED visits, evidence of OUD, or OUD treatment referral following discontinuation. ","['patients in the Transforming Opioid', 'Subjects\n\n\nPatients in both TOPCARE study arms who discontinued opioid therapy during the trial']","['nurse care manager support, an electronic registry, academic detailing, and electronic tools, and control PCPs received electronic tools only']","['PCP visits, one or more pain-related emergency department (ED) visits, evidence of opioid use disorder (OUD), and referral for OUD treatment', 'PCP follow', 'pain-related ED visits, evidence of OUD, or OUD treatment referral', 'Opioid discontinuations']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C1706472', 'cui_str': 'Discontinue - dosing instruction imperative'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0687694', 'cui_str': 'Case Manager'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C4281784', 'cui_str': 'Electronics'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C0336791', 'cui_str': 'Tool, device (physical object)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0031381', 'cui_str': '1-(1-Phenylcyclohexyl)piperidine'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0332120', 'cui_str': 'Evidence of (contextual qualifier) (qualifier value)'}, {'cui': 'C4324621', 'cui_str': 'Opioid use disorder'}, {'cui': 'C2585524', 'cui_str': 'Referral for'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0034927', 'cui_str': 'Referral'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}]",,0.0552494,"We found no differences between groups for pain-related ED visits, evidence of OUD, or OUD treatment referral following discontinuation. ","[{'ForeName': 'Jawad M', 'Initials': 'JM', 'LastName': 'Husain', 'Affiliation': 'Department of Psychiatry.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'LaRochelle', 'Affiliation': 'Section of General Internal Medicine, Boston Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Keosaian', 'Affiliation': 'Section of General Internal Medicine, Boston Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Ziming', 'Initials': 'Z', 'LastName': 'Xuan', 'Affiliation': 'Clinical Addiction Research and Education Unit, Boston University School of Medicine, Boston, Massachusetts.'}, {'ForeName': 'Karen E', 'Initials': 'KE', 'LastName': 'Lasser', 'Affiliation': 'Section of General Internal Medicine, Boston Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Jane M', 'Initials': 'JM', 'LastName': 'Liebschutz', 'Affiliation': 'Clinical Addiction Research and Education Unit, Boston University School of Medicine, Boston, Massachusetts.'}]","Pain medicine (Malden, Mass.)",['10.1093/pm/pny124'] 748,29546280,Metabolic Inflexibility Is an Early Marker of Bed-Rest-Induced Glucose Intolerance Even When Fat Mass Is Stable.,"Context The effects of energy-balanced bed rest on metabolic flexibility have not been thoroughly examined. Objective We investigated the effects of 21 days of bed rest, with and without whey protein supplementation, on metabolic flexibility while maintaining energy balance. We hypothesized that protein supplementation mitigates metabolic inflexibility by preventing muscle atrophy. Design and Setting Randomized crossover longitudinal study conducted at the German Aerospace Center, Cologne, Germany. Participants and Interventions Ten healthy men were randomly assigned to dietary countermeasure or isocaloric control diet during a 21-day bed rest. Outcome Measures Before and at the end of the bed rest, metabolic flexibility was assessed during a meal test. Secondary outcomes were glucose tolerance by oral glucose tolerance test, body composition by dual energy X-ray absorptiometry, ectopic fat storage by magnetic resonance imaging, and inflammation and oxidative stress markers. Results Bed rest decreased the ability to switch from fat to carbohydrate oxidation when transitioning from fasted to fed states (i.e., metabolic inflexibility), antioxidant capacity, fat-free mass (FFM), and muscle insulin sensitivity along with greater fat deposition in muscle (P < 0.05 for all). Changes in fasting insulin and inflammation were not observed. However, glucose tolerance was reduced during acute overfeeding. Protein supplementation did not prevent FFM loss and metabolic alterations. Conclusions Physical inactivity triggers metabolic inflexibility, even when energy balance is maintained. Although reduced insulin sensitivity and increased fat deposition were observed at the muscle level, systemic glucose intolerance was detected only in response to a moderately high-fat meal. This finding supports the role of physical inactivity in metabolic inflexibility and suggests that metabolic inflexibility precedes systemic glucose intolerance.",2018,Changes in fasting insulin and inflammation were not observed.,['Participants and Interventions\n\n\nTen healthy men'],"['Protein supplementation', 'bed rest, with and without whey protein supplementation', 'protein supplementation', 'dietary countermeasure or isocaloric control diet', 'energy-balanced bed rest']","['glucose tolerance', 'Glucose Intolerance', 'FFM loss and metabolic alterations', 'ability to switch from fat to carbohydrate oxidation', 'insulin sensitivity and increased fat deposition', 'muscle level, systemic glucose intolerance', 'metabolic inflexibility), antioxidant capacity, fat-free mass (FFM), and muscle insulin sensitivity', 'fasting insulin and inflammation', 'metabolic flexibility', 'glucose tolerance by oral glucose tolerance test, body composition by dual energy X-ray absorptiometry, ectopic fat storage by magnetic resonance imaging, and inflammation and oxidative stress markers']","[{'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C0770246', 'cui_str': 'Protein supplement'}, {'cui': 'C0004910', 'cui_str': 'Bedrest'}, {'cui': 'C0078479', 'cui_str': 'Whey Proteins'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}]","[{'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0231197', 'cui_str': 'Tolerance, function (observable entity)'}, {'cui': 'C0271650', 'cui_str': 'Glucose Intolerance'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}, {'cui': 'C0030011', 'cui_str': 'Oxidation, function (observable entity)'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0333562', 'cui_str': 'Deposition (morphologic abnormality)'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0424679', 'cui_str': 'Fat-free mass (observable entity)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C1510486', 'cui_str': 'Dual X-Ray Absorptiometry'}, {'cui': 'C0340464', 'cui_str': 'Premature Cardiac Complex'}, {'cui': 'C1698986', 'cui_str': 'Storage (procedure)'}, {'cui': 'C1552358', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0242606', 'cui_str': 'Oxidative Stress'}]",10.0,0.0480881,Changes in fasting insulin and inflammation were not observed.,"[{'ForeName': 'Floriane', 'Initials': 'F', 'LastName': 'Rudwill', 'Affiliation': 'Université de Strasbourg, CNRS, IPHC UMR 7178, Strasbourg, France.'}, {'ForeName': 'Donal', 'Initials': 'D', 'LastName': ""O'Gorman"", 'Affiliation': '3U Diabetes Consortium, Dublin City University, Dublin, Ireland.'}, {'ForeName': 'Etienne', 'Initials': 'E', 'LastName': 'Lefai', 'Affiliation': 'Carmen INSERM U1060, University of Lyon, INRA U1235, Lyon, France.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Chery', 'Affiliation': 'Université de Strasbourg, CNRS, IPHC UMR 7178, Strasbourg, France.'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Zahariev', 'Affiliation': 'Université de Strasbourg, CNRS, IPHC UMR 7178, Strasbourg, France.'}, {'ForeName': 'Sylvie', 'Initials': 'S', 'LastName': 'Normand', 'Affiliation': 'Human Nutrition Research Centre of Rhône-Alpes, Hospices Civils de Lyon, Lyon, France.'}, {'ForeName': 'Allan F', 'Initials': 'AF', 'LastName': 'Pagano', 'Affiliation': 'Université de Montpellier, INRA, UMR 866 Dynamique Musculaire et Métabolisme, Montpellier, France.'}, {'ForeName': 'Angèle', 'Initials': 'A', 'LastName': 'Chopard', 'Affiliation': 'Université de Montpellier, INRA, UMR 866 Dynamique Musculaire et Métabolisme, Montpellier, France.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Damiot', 'Affiliation': 'Université de Strasbourg, CNRS, IPHC UMR 7178, Strasbourg, France.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Laurens', 'Affiliation': 'Université de Strasbourg, CNRS, IPHC UMR 7178, Strasbourg, France.'}, {'ForeName': 'Leanne', 'Initials': 'L', 'LastName': 'Hodson', 'Affiliation': 'Oxford Centre for Diabetes, Endocrinology and Metabolism, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Emmanuelle', 'Initials': 'E', 'LastName': 'Canet-Soulas', 'Affiliation': 'Carmen INSERM U1060, University of Lyon, INRA U1235, Lyon, France.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Heer', 'Affiliation': 'Institute of Nutritional and Food Sciences, Human Nutrition, University of Bonn, Bonn, Germany.'}, {'ForeName': 'Petra Frings', 'Initials': 'PF', 'LastName': 'Meuthen', 'Affiliation': 'German Aerospace Center (DLR), Institute of Aerospace Medicine, Cologne, Germany.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Buehlmeier', 'Affiliation': 'German Aerospace Center (DLR), Institute of Aerospace Medicine, Cologne, Germany.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Baecker', 'Affiliation': 'German Aerospace Center (DLR), Institute of Aerospace Medicine, Cologne, Germany.'}, {'ForeName': 'Laure', 'Initials': 'L', 'LastName': 'Meiller', 'Affiliation': 'Carmen INSERM U1060, University of Lyon, INRA U1235, Lyon, France.'}, {'ForeName': 'Guillemette', 'Initials': 'G', 'LastName': 'Gauquelin-Koch', 'Affiliation': ""Centre National d'Etudes Spatiales, Paris, France.""}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Blanc', 'Affiliation': 'Université de Strasbourg, CNRS, IPHC UMR 7178, Strasbourg, France.'}, {'ForeName': 'Chantal', 'Initials': 'C', 'LastName': 'Simon', 'Affiliation': 'Carmen INSERM U1060, University of Lyon, INRA U1235, Lyon, France.'}, {'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'Bergouignan', 'Affiliation': 'Université de Strasbourg, CNRS, IPHC UMR 7178, Strasbourg, France.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/jc.2017-02267'] 749,29300256,Randomized Controlled Trial to Assess the Impact of Intraurethral Lidocaine on Urodynamic Voiding Parameters.,"OBJECTIVES The aim of the study was to determine whether intraurethral anesthesia decreases voiding efficiency (VE; voided volume/(voided volume + residual volume)) and impacts other urodynamic parameters in healthy female volunteers during urodynamic studies. METHODS This was a randomized double-blind placebo-controlled study of asymptomatic women aged 18 to 60 years. Subjects completed a visual analog scale and baseline questionnaires to assess pain and lower urinary tract symptoms, respectively. They performed an uninstrumented baseline uroflow, followed by physiologic filling to 250 mL or greater. Subjects were randomized to receive 5 mL of intraurethral aqueous gel or 2% lidocaine gel and then underwent a second uninstrumented uroflow. They then completed complex cystometry, urethral pressure profilometry, and pressure-flow studies. RESULTS Twenty-three randomized subjects (12 placebo, 11 lidocaine) were included. Baseline uroflow VE was similar between the placebo and lidocaine groups. After study drug administration, VE was not different between groups (89.3 [85.9-93.9] vs 89.5 [82.5-91.7], P = 0.74). There were also no differences between groups in visual analog scale scores, sensation during cystometry, maximum urethral closure pressure, or micturition parameters (maximum detrusor pressure and detrusor pressure at maximum flow). The placebo group had a lower percentage of interrupted flow pattern (0% vs 36%, P = 0.02) and a lower rate of increased electromyographic activity during micturition (25% vs 73%, P = 0.02). CONCLUSIONS In this pilot study of 23 asymptomatic women, intraurethral administration of lidocaine did not decrease VE compared with placebo. The lidocaine group had a greater percentage of interrupted flow patterns and increased electromyographic activity during micturition.",2019,"The placebo group had a lower percentage of interrupted flow pattern (0% vs 36%, P = 0.02) and a lower rate of increased electromyographic activity during micturition (25% vs 73%, P = 0.02). ","['healthy female volunteers during urodynamic studies', 'asymptomatic women aged 18 to 60 years', 'Twenty-three randomized subjects (12', '23 asymptomatic women']","['placebo', 'intraurethral anesthesia decreases voiding efficiency (VE; voided volume/(voided volume + residual volume', 'lidocaine', 'Intraurethral Lidocaine', '5 mL of intraurethral aqueous gel or 2% lidocaine gel', 'placebo, 11 lidocaine']","['visual analog scale scores, sensation during cystometry, maximum urethral closure pressure, or micturition parameters (maximum detrusor pressure and detrusor pressure at maximum flow', 'percentage of interrupted flow patterns', 'percentage of interrupted flow pattern', 'electromyographic activity', 'Urodynamic Voiding Parameters', 'visual analog scale and baseline questionnaires to assess pain and lower urinary tract symptoms']","[{'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C2239180', 'cui_str': 'Urodynamic studies (procedure)'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0450348', 'cui_str': '23 (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0035190', 'cui_str': 'Residual respiratory volume (observable entity)'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0017243', 'cui_str': 'Gel (basic dose form)'}]","[{'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0036658', 'cui_str': 'Sensory Function'}, {'cui': 'C0200000', 'cui_str': 'Cystometrogram (procedure)'}, {'cui': 'C0429760', 'cui_str': 'Maximum urethral closure pressure (observable entity)'}, {'cui': 'C0042034', 'cui_str': 'Micturition'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0429766', 'cui_str': 'Detrusor pressure (observable entity)'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0042059', 'cui_str': 'Urodynamics'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0574785', 'cui_str': 'Lower Urinary Tract Symptoms'}]",23.0,0.675468,"The placebo group had a lower percentage of interrupted flow pattern (0% vs 36%, P = 0.02) and a lower rate of increased electromyographic activity during micturition (25% vs 73%, P = 0.02). ","[{'ForeName': 'Cassandra K', 'Initials': 'CK', 'LastName': 'Kisby', 'Affiliation': ''}, {'ForeName': 'Eric J', 'Initials': 'EJ', 'LastName': 'Gonzalez', 'Affiliation': 'Department of Biomedical Engineering, Duke University.'}, {'ForeName': 'Anthony G', 'Initials': 'AG', 'LastName': 'Visco', 'Affiliation': 'Department of Obstetrics and Gynecology, Division of Female Pelvic Medicine and Reconstructive Surgery, Duke Hospital, Durham, NC.'}, {'ForeName': 'Cindy L', 'Initials': 'CL', 'LastName': 'Amundsen', 'Affiliation': 'Department of Obstetrics and Gynecology, Division of Female Pelvic Medicine and Reconstructive Surgery, Duke Hospital, Durham, NC.'}, {'ForeName': 'Warren M', 'Initials': 'WM', 'LastName': 'Grill', 'Affiliation': 'Department of Biomedical Engineering, Duke University.'}]",Female pelvic medicine & reconstructive surgery,['10.1097/SPV.0000000000000544'] 750,29659126,Guanfacine decreases symptoms of cannabis withdrawal in daily cannabis smokers.,"The α2a-adrenergic agonist, lofexidine, reduced cannabis withdrawal-related sleep disruption in the laboratory, but side effects (e.g. fatigue, hypotension) limit its utility as a treatment for cannabis use disorder. This study tested the potential efficacy and tolerability of a daily bedtime administration of the FDA-approved α2a-adrenergic agonist, guanfacine, in a human laboratory model of cannabis use disorder. Daily, nontreatment-seeking cannabis smokers (13M, 2F) completed a within-subject study comprising two 9-day inpatient study phases. Each phase tested the effects of daily placebo or immediate-release guanfacine (2 mg) on cannabis intoxication (5.6 percent THC; 2 days), withdrawal (4 days of abstinence) and subsequent 'relapse' (3 days of cannabis self-administration). Ratings of mood, sleep, cardiovascular effects, food intake, psychomotor performance and cannabis self-administration were assessed. An outpatient phase preceded each inpatient phase for medication clearance or dose induction. Under placebo medication conditions, cannabis abstinence produced significant withdrawal, including irritability, sleep disruption and anorexia. Guanfacine reduced ratings of irritability and improved objective measures of sleep during cannabis withdrawal relative to placebo but did not reduce cannabis self-administration. Guanfacine was well tolerated with little evidence of fatigue and only small decreases in blood pressure: no dose was held due to hypotension. Thus, a single daily administration of guanfacine at bedtime improved sleep and mood during cannabis withdrawal relative to placebo. This positive signal supports further studies varying the guanfacine dose, formulation or frequency of administration, or combining it with other medications to increase the likelihood of having an impact on cannabis use.",2019,Guanfacine reduced ratings of irritability and improved objective measures of sleep during cannabis withdrawal relative to placebo but did not reduce cannabis self-administration.,"['Daily, nontreatment-seeking cannabis smokers (13M, 2F) completed a within-subject study comprising two 9-day inpatient study phases', 'daily cannabis smokers']","['lofexidine', 'placebo', 'placebo or immediate-release guanfacine', 'Guanfacine', 'guanfacine', 'FDA-approved α2a-adrenergic agonist, guanfacine']","['blood pressure', 'irritability, sleep disruption and anorexia', 'cannabis intoxication', 'potential efficacy and tolerability', 'ratings of irritability', 'sleep and mood', 'Ratings of mood, sleep, cardiovascular effects, food intake, psychomotor performance and cannabis self-administration']","[{'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0678449', 'cui_str': 'Cannabis'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}]","[{'cui': 'C0065152', 'cui_str': 'lofexidine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0079466', 'cui_str': 'Guanfacine'}, {'cui': 'C0001648', 'cui_str': 'Adrenomimetics'}]","[{'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0022107', 'cui_str': 'Irritable Mood'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0332453', 'cui_str': 'Disruption (morphologic abnormality)'}, {'cui': 'C1971624', 'cui_str': 'Loss of appetite (finding)'}, {'cui': 'C0006872', 'cui_str': 'Cannabis sativa poisoning (disorder)'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}, {'cui': 'C0033923', 'cui_str': 'Psychomotor Performance'}, {'cui': 'C0678449', 'cui_str': 'Cannabis'}, {'cui': 'C0036589', 'cui_str': 'Self Administration'}]",,0.277342,Guanfacine reduced ratings of irritability and improved objective measures of sleep during cannabis withdrawal relative to placebo but did not reduce cannabis self-administration.,"[{'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Haney', 'Affiliation': 'Division on Substance Use Disorders, New York State Psychiatric Institute and Department of Psychiatry, Columbia University Medical Center, New York, NY, USA.'}, {'ForeName': 'Ziva D', 'Initials': 'ZD', 'LastName': 'Cooper', 'Affiliation': 'Division on Substance Use Disorders, New York State Psychiatric Institute and Department of Psychiatry, Columbia University Medical Center, New York, NY, USA.'}, {'ForeName': 'Gillinder', 'Initials': 'G', 'LastName': 'Bedi', 'Affiliation': 'Division on Substance Use Disorders, New York State Psychiatric Institute and Department of Psychiatry, Columbia University Medical Center, New York, NY, USA.'}, {'ForeName': 'Evan', 'Initials': 'E', 'LastName': 'Herrmann', 'Affiliation': 'Division on Substance Use Disorders, New York State Psychiatric Institute and Department of Psychiatry, Columbia University Medical Center, New York, NY, USA.'}, {'ForeName': 'Sandra D', 'Initials': 'SD', 'LastName': 'Comer', 'Affiliation': 'Division on Substance Use Disorders, New York State Psychiatric Institute and Department of Psychiatry, Columbia University Medical Center, New York, NY, USA.'}, {'ForeName': 'Stephanie Collins', 'Initials': 'SC', 'LastName': 'Reed', 'Affiliation': 'Division on Substance Use Disorders, New York State Psychiatric Institute and Department of Psychiatry, Columbia University Medical Center, New York, NY, USA.'}, {'ForeName': 'Richard W', 'Initials': 'RW', 'LastName': 'Foltin', 'Affiliation': 'Division on Substance Use Disorders, New York State Psychiatric Institute and Department of Psychiatry, Columbia University Medical Center, New York, NY, USA.'}, {'ForeName': 'Frances R', 'Initials': 'FR', 'LastName': 'Levin', 'Affiliation': 'Division on Substance Use Disorders, New York State Psychiatric Institute and Department of Psychiatry, Columbia University Medical Center, New York, NY, USA.'}]",Addiction biology,['10.1111/adb.12621'] 751,32123242,Does resistance training have an effect on levels of ferritin and atherogenic lipids in postmenopausal women? - A pilot trial.,"The objective of this study was to determine if 15 weeks of resistance training (RT) can alter the levels of blood lipids, body iron status, and oxidative stress in postmenopausal women with vasomotor symptoms. Postmenopausal women enrolled in a randomised controlled trial were allocated to either a sedentary control group (n = 29) or a RT group (n = 26). Blood samples were taken at week-0 and week-15 for all participants. Blood lipids and iron status were measured via routine clinical analyses. Immunoassays were used to measure oxidative stress markers. The RT group, with good compliance, was associated with significant reductions in ferritin, total cholesterol, low-density lipoprotein, and non-high-density lipoprotein cholesterol. Moreover, ferritin was positively correlated with atherogenic lipids while negatively correlated with high-density lipoprotein in RT women. This occurred without alterations in serum iron, transferrin, transferrin-saturation, C-reactive protein and oxidative stress markers. No differences were found in control women. This study suggests that RT in postmenopausal women both reduces levels of ferritin and counteracts atherogenic lipid profiles independent of an apparent oxidative mechanism. RT may be a beneficial intervention in postmenopausal women via an interaction between ferritin and lipids; however, further investigation in a larger cohort is essential.",2020,"The RT group, with good compliance, was associated with significant reductions in ferritin, total cholesterol, low-density lipoprotein, and non-high-density lipoprotein cholesterol.","['postmenopausal women', 'postmenopausal women with vasomotor symptoms', 'Postmenopausal women']","['sedentary control group (n\u2009=\u200929) or a RT', 'resistance training (RT']","['levels of ferritin and atherogenic lipids', 'levels of blood lipids, body iron status, and oxidative stress', 'atherogenic lipids', 'oxidative stress markers', 'Blood lipids and iron status', 'serum iron, transferrin, transferrin-saturation, C-reactive protein and oxidative stress markers', 'ferritin, total cholesterol, low-density lipoprotein, and non-high-density lipoprotein\xa0cholesterol']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]","[{'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0373607', 'cui_str': 'Ferritin measurement (procedure)'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0005768'}, {'cui': 'C0337439', 'cui_str': 'Iron measurement (procedure)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0242606', 'cui_str': 'Oxidative Stress'}, {'cui': 'C1318312', 'cui_str': 'Serum iron measurement'}, {'cui': 'C0040679', 'cui_str': 'beta-1 Metal-Binding Globulin'}, {'cui': 'C1277709', 'cui_str': 'Transferrin saturation index (procedure)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0729627', 'cui_str': 'Non-HDL cholesterol'}]",,0.105155,"The RT group, with good compliance, was associated with significant reductions in ferritin, total cholesterol, low-density lipoprotein, and non-high-density lipoprotein cholesterol.","[{'ForeName': 'Liam J', 'Initials': 'LJ', 'LastName': 'Ward', 'Affiliation': 'Department of Obstetrics and Gynaecology in Linköping, and Department of Biomedical and Clinical Sciences, Linköping University, Linköping, Sweden. liam.ward@liu.se.'}, {'ForeName': 'Mats', 'Initials': 'M', 'LastName': 'Hammar', 'Affiliation': 'Department of Obstetrics and Gynaecology in Linköping, and Department of Biomedical and Clinical Sciences, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Lotta', 'Initials': 'L', 'LastName': 'Lindh-Åstrand', 'Affiliation': 'Department of Obstetrics and Gynaecology in Linköping, and Department of Biomedical and Clinical Sciences, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Emilia', 'Initials': 'E', 'LastName': 'Berin', 'Affiliation': 'Department of Obstetrics and Gynaecology in Linköping, and Department of Biomedical and Clinical Sciences, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Hanna', 'Initials': 'H', 'LastName': 'Lindblom', 'Affiliation': 'Department of Health, Medicine and Caring Sciences, Unit of Physiotherapy, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Rubér', 'Affiliation': 'Department of Obstetrics and Gynaecology in Linköping, and Department of Biomedical and Clinical Sciences, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Anna-Clara', 'Initials': 'AC', 'LastName': 'Spetz Holm', 'Affiliation': 'Department of Obstetrics and Gynaecology in Linköping, and Department of Biomedical and Clinical Sciences, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'Department of Obstetrics and Gynaecology in Linköping, and Department of Biomedical and Clinical Sciences, Linköping University, Linköping, Sweden. wei.li@liu.se.'}]",Scientific reports,['10.1038/s41598-020-60759-z'] 752,31420412,TRUST: Trial of Radical Upfront Surgical Therapy in advanced ovarian cancer (ENGOT ov33/AGO-OVAR OP7).,"BACKGROUND Primary cytoreductive surgery followed by chemotherapy has been considered standard management for patients with advanced ovarian cancer over decades. An alternative approach of interval debulking surgery following neoadjuvant chemotherapy was subsequently reported by two randomized phase III trials (EORTC-GCG, CHORUS), which were criticized owing to important limitations, especially regarding the rate of complete resection. PRIMARY OBJECTIVE To clarify the optimal timing of surgical therapy in advanced ovarian cancer. STUDY HYPOTHESIS Primary cytoreductive surgery is superior to interval cytoreductive surgery following neoadjuvant chemotherapy for overall survival in patients with advanced ovarian cancer. TRIAL DESIGN TRUST is an international open, randomized, controlled multi-center trial investigating overall survival after primary cytoreductive surgery versus neoadjuvant chemotherapy and subsequent interval cytoreductive surgery in patients with FIGO stage IIIB-IVB ovarian, tubal, and peritoneal carcinoma. To guarantee adequate surgical quality, participating centers need to fulfill specific quality assurance criteria (eg, ≥50% complete resection rate in upfront surgery for FIGO IIIB-IVB patients, ≥36 debulking-surgeries/year) and agree to independent audits by TRUST quality committee delegates. Patients in the primary cytoreductive surgery arm undergo surgery followed by 6 cycles of platinum-based chemotherapy, whereas patients in the interval cytoreductive surgery arm undergo 3 cycles of neoadjuvant chemotherapy after histologic confirmation of the disease, followed by interval cytoreductive surgery and subsequently, 3 cycles of platinum-based chemotherapy. The intention of surgery for both groups is complete tumor resection according to guideline recommendations. MAJOR INCLUSION/EXCLUSION CRITERIA Major inclusion criteria are suspected or histologically confirmed, newly diagnosed invasive epithelial ovarian cancer, fallopian tube carcinoma, or primary peritoneal carcinoma FIGO stage IIIB-IVB (IV only if resectable metastasis). Major exclusion criteria are non-epithelial ovarian malignancies and borderline tumors; prior chemotherapy for ovarian cancer; or abdominal/pelvic radiotherapy. PRIMARY ENDPOINT Overall survival. SAMPLE SIZE 772 patients. ESTIMATED DATES FOR COMPLETING ACCRUAL AND PRESENTING RESULTS Accrual completion approximately mid-2019, results are expected after 5 years' follow-up in 2024. TRIAL REGISTRATION NCT02828618.",2019,"Primary cytoreductive surgery is superior to interval cytoreductive surgery following neoadjuvant chemotherapy for overall survival in patients with advanced ovarian cancer. ","['772 patients', 'advanced ovarian cancer', 'advanced ovarian cancer (ENGOT ov33/AGO-OVAR OP7', 'Major inclusion criteria are suspected or histologically confirmed, newly diagnosed invasive epithelial ovarian cancer, fallopian tube carcinoma, or primary peritoneal carcinoma FIGO stage IIIB-IVB (IV only if resectable metastasis', 'patients with advanced ovarian cancer', 'patients with FIGO stage IIIB-IVB ovarian, tubal, and peritoneal carcinoma']","['Radical Upfront Surgical Therapy', 'interval cytoreductive surgery arm undergo 3 cycles of neoadjuvant chemotherapy', 'platinum-based chemotherapy', 'primary cytoreductive surgery arm undergo surgery followed by 6 cycles of platinum-based chemotherapy', 'interval debulking surgery following neoadjuvant chemotherapy', 'primary cytoreductive surgery versus neoadjuvant chemotherapy and subsequent interval cytoreductive surgery', 'interval cytoreductive surgery', 'neoadjuvant chemotherapy', 'surgical therapy', 'TRUST']","['Overall survival', 'overall survival']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C1140680', 'cui_str': 'Ovary Cancer'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0750491', 'cui_str': 'Suspected (qualifier value)'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0677886', 'cui_str': 'Carcinoma, Ovarian Epithelial'}, {'cui': 'C0015560', 'cui_str': 'Oviducts, Mammalian'}, {'cui': 'C0007097', 'cui_str': 'Epithelioma'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0948303', 'cui_str': 'Peritoneal carcinoma'}, {'cui': 'C0450454', 'cui_str': 'FIGO Stage'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}]","[{'cui': 'C0439807', 'cui_str': 'Radical - extent'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C3850079', 'cui_str': 'Cytoreductive Surgery'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C1706406', 'cui_str': 'Interventional debulking surgery (procedure)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0237935', 'cui_str': 'Trust'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",772.0,0.3548,"Primary cytoreductive surgery is superior to interval cytoreductive surgery following neoadjuvant chemotherapy for overall survival in patients with advanced ovarian cancer. ","[{'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Reuss', 'Affiliation': 'AGO Study Group and Coordinating Centre for Clinical Trials, Philipps-Universität Marburg, Marburg, Germany alexander.reuss@kks.uni-marburg.de.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'du Bois', 'Affiliation': 'AGO Study Group and Department of Gynecology and Gynecologic Oncology, Kliniken Essen-Mitte Evangelische Huyssens-Stiftung/Knappschaft GmbH, Essen, Germany.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Harter', 'Affiliation': 'AGO Study Group and Department of Gynecology and Gynecologic Oncology, Kliniken Essen-Mitte Evangelische Huyssens-Stiftung/Knappschaft GmbH, Essen, Germany.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Fotopoulou', 'Affiliation': 'AGO Study Group and West London Gynecological Cancer Centre; Imperial College Healthcare NHS Trust, London, UK.'}, {'ForeName': 'Jalid', 'Initials': 'J', 'LastName': 'Sehouli', 'Affiliation': 'AGO Study Group and Department of Gynecologic Oncology, Charite Comprehensive Cancer Center Berlin, Berlin, Germany.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Aletti', 'Affiliation': 'MANGO and Department of Gynecology, Istituto Europeo di Oncologia, Milano, Italy.'}, {'ForeName': 'Frederic', 'Initials': 'F', 'LastName': 'Guyon', 'Affiliation': 'GINECO and Institut Bergonie, Bordeaux, France.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Greggi', 'Affiliation': 'Department of Gynecologic Oncology Surgery, Istituto Nazionale Tumori IRCCS Fondazione Pascale, Naples, Italy.'}, {'ForeName': 'Berit Jul', 'Initials': 'BJ', 'LastName': 'Mosgaard', 'Affiliation': 'NSGO and Copenhagen University Hospital Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Reinthaller', 'Affiliation': 'Department of Obstetrics and Gynecology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Hilpert', 'Affiliation': 'AGO Study Group and Mammazentrum am Krankenhaus Jerusalem, Hamburg, Germany.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Schade-Brittinger', 'Affiliation': 'AGO Study Group and Coordinating Centre for Clinical Trials, Philipps-Universität Marburg, Marburg, Germany.'}, {'ForeName': 'Dennis S', 'Initials': 'DS', 'LastName': 'Chi', 'Affiliation': 'AGO Study Group and Gynecology Service, Memorial Sloan-Kettering Cancer Center, New York, New York, USA.'}, {'ForeName': 'Sven', 'Initials': 'S', 'LastName': 'Mahner', 'Affiliation': 'AGO Study Group and Department of Obstetrics and Gynecology, University Hospital, Ludwig Maximilians University Munich, Munich, Bayern, Germany.'}]",International journal of gynecological cancer : official journal of the International Gynecological Cancer Society,['10.1136/ijgc-2019-000682'] 753,29053410,The effect of moderate-intensity exercise on nightly variability in objectively measured sleep parameters among older women.,"Objective/Background : Exercise training has been demonstrated to beneficially influence mean-level measures of sleep; however, few studies have examined the impact of an exercise intervention on night-to-night variability in sleep. This study investigated whether four months of moderate-intensity exercise impacted night-to-night variability in sleep among older women. Methods : Participants ( n  = 49) were randomized to one of two moderate-intensity walking programs with different doses of energy expenditure: low-dose ( n  = 23: 8 kcal/kg of body weight per week) or high-dose ( n  = 26: 14 kcal/kg of body weight per week). Sleep parameters were assessed objectively via actigraphy at baseline, mid- (2 months), and postintervention (4 months). Nightly variability in each of the sleep parameters was calculated using the seven-day standard deviation ( SD ) and a coefficient of variation ( SD /mean x 100%). Cardiorespiratory fitness (VO 2peak ) was measured at baseline and postintervention using a graded treadmill test. Results : Both measures of nightly variability demonstrated a borderline to significantly lower amount of night-to-night variability in wake time after sleep onset (WASO) and number of awakenings at postintervention in comparison to baseline ( p  ≤ 0.05). Higher VO 2peak levels at baseline were associated with less time in bed and lower total sleep time variability throughout the exercise intervention ( p  < 0.05). Conclusion : Overall, participation in moderate-intensity exercise was observed to reduce the amount of nightly variability for WASO and number of awakenings over time in older women.",2019,Higher VO 2peak levels at baseline were associated with less time in bed and lower total sleep time variability throughout the exercise intervention ( p  < 0.05). ,"['older women', 'Participants ( n\xa0 =\xa049']","['exercise intervention', 'moderate-intensity exercise impacted night-to-night variability', 'Exercise training', ' ', 'moderate-intensity walking programs with different doses of energy expenditure: low-dose ( n \xa0=\xa023: 8 kcal/kg of body weight per week) or high-dose', 'moderate-intensity exercise']","['Higher VO 2peak levels', 'Cardiorespiratory fitness (VO 2peak ', 'total sleep time variability', 'Sleep parameters', 'night-to-night variability in wake time after sleep onset (WASO) and number of awakenings']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0014272', 'cui_str': 'Energy Expenditure'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0439259', 'cui_str': 'kilocalorie'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0442696', 'cui_str': 'Waking (observable entity)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1720052', 'cui_str': 'Awakening'}]",49.0,0.0292405,Higher VO 2peak levels at baseline were associated with less time in bed and lower total sleep time variability throughout the exercise intervention ( p  < 0.05). ,"[{'ForeName': 'Charity B', 'Initials': 'CB', 'LastName': 'Breneman', 'Affiliation': 'a South Carolina Rural Health Research Center, Arnold School of Public Health , University of South Carolina , Columbia , South Carolina , USA.'}, {'ForeName': 'Christopher E', 'Initials': 'CE', 'LastName': 'Kline', 'Affiliation': 'b Department of Health & Physical Activity, School of Education , University of Pittsburgh , Pittsburgh , Pennsylvania , USA.'}, {'ForeName': 'Delia S', 'Initials': 'DS', 'LastName': 'West', 'Affiliation': 'c Department of Exercise Science, Arnold School of Public Health , University of South Carolina , Columbia , South Carolina , USA.'}, {'ForeName': 'Xuemei', 'Initials': 'X', 'LastName': 'Sui', 'Affiliation': 'c Department of Exercise Science, Arnold School of Public Health , University of South Carolina , Columbia , South Carolina , USA.'}, {'ForeName': 'Ryan R', 'Initials': 'RR', 'LastName': 'Porter', 'Affiliation': 'c Department of Exercise Science, Arnold School of Public Health , University of South Carolina , Columbia , South Carolina , USA.'}, {'ForeName': 'Kimberly P', 'Initials': 'KP', 'LastName': 'Bowyer', 'Affiliation': 'c Department of Exercise Science, Arnold School of Public Health , University of South Carolina , Columbia , South Carolina , USA.'}, {'ForeName': 'Sabra', 'Initials': 'S', 'LastName': 'Custer', 'Affiliation': 'd College of Nursing , University of South Carolina , Columbia , South Carolina , USA.'}, {'ForeName': 'Xuewen', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'c Department of Exercise Science, Arnold School of Public Health , University of South Carolina , Columbia , South Carolina , USA.'}]",Behavioral sleep medicine,['10.1080/15402002.2017.1395337'] 754,29757375,Establishing the Feasibility of a Tablet-Based Consent Process with Older Adults: A Mixed-Methods Study.,"Purpose of the Study This mixed-methods study explored the feasibility and acceptability of using a tablet-based research consent process with adults aged ≥65 years. Design and Methods In the first phase, focus group participants reported on their perceptions of a tablet-based consent process. In the second phase, older adults were randomized to view either a tablet-based or paper-based consent for a mock clinical trial. Measurements included: time to complete, adverse/unexpected events, user-friendliness, immediate comprehension, and retention at a 1-week delay. Results Focus group participants (N = 15) expressed interest in the novel format, cautioning that peers would need comprehensive orientation to use the technology. In the randomized pilot (N = 20), retention was 100% and all participants completed the protocol without the occurrence of adverse/unexpected events. Although the participants took longer to complete the tablet-based consent than the paper-based version, user-friendliness, immediate comprehension, and retention of the tablet-based consent were similar to the paper-based consent. Discussion and Implications The findings suggest that a tablet-based consent process is feasible to implement with older adults and acceptable to this population, but we would underscore that efforts to optimize design of tablet-based consent forms for older adults are warranted.",2019,"Measurements included: time to complete, adverse/unexpected events, user-friendliness, immediate comprehension, and retention at a 1-week delay. ","['older adults', 'Older Adults', 'adults aged ≥65 years']",['tablet-based or paper-based consent'],"[' time to complete, adverse/unexpected events, user-friendliness, immediate comprehension, and retention at a 1-week delay']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C1705223', 'cui_str': 'Tablet'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0030351', 'cui_str': 'Paper'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]",,0.0331594,"Measurements included: time to complete, adverse/unexpected events, user-friendliness, immediate comprehension, and retention at a 1-week delay. ","[{'ForeName': 'Nimali', 'Initials': 'N', 'LastName': 'Jayasinghe', 'Affiliation': 'Weill Cornell Medicine, New York, New York.'}, {'ForeName': 'B Isabel', 'Initials': 'BI', 'LastName': 'Moallem', 'Affiliation': 'Weill Cornell Medicine, New York, New York.'}, {'ForeName': 'Margo', 'Initials': 'M', 'LastName': 'Kakoullis', 'Affiliation': 'Weill Cornell Medicine, New York, New York.'}, {'ForeName': 'Mary-Jane', 'Initials': 'MJ', 'LastName': 'Ojie', 'Affiliation': 'Weill Cornell Medicine, New York, New York.'}, {'ForeName': 'Lili', 'Initials': 'L', 'LastName': 'Sar-Graycar', 'Affiliation': 'Weill Cornell Medicine, New York, New York.'}, {'ForeName': 'Katarzyna', 'Initials': 'K', 'LastName': 'Wyka', 'Affiliation': 'Weill Cornell Medicine, New York, New York.'}, {'ForeName': 'M Cary', 'Initials': 'MC', 'LastName': 'Reid', 'Affiliation': 'Weill Cornell Medicine, New York, New York.'}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Leonard', 'Affiliation': 'Weill Cornell Medicine, New York, New York.'}]",The Gerontologist,['10.1093/geront/gny045'] 755,29059120,"Change in Depression, Confidence, and Physical Function Among Older Adults With Mild Cognitive Impairment.","BACKGROUND AND PURPOSE Nearly a quarter of those in the United States older than 71 years experience mild cognitive impairment. Persons with mild cognitive impairment battle depression and progressive disengagement from daily activities, which contribute to participation restriction and activity limitation. Daily engagement in meaningful activity (DEMA) is a tailored intervention designed to benefit persons with mild cognitive impairment and their caregivers through preserved engagement and supported adjustment to cognitive changes. This secondary analysis was guided by the International Classification of Functioning, Disability and Health (ICF) model. Aims were to (i) explore the extent to which change in self-rated activity performance and physical function can predict change in depressive symptoms, (ii) evaluate for difference in confidence and depressive symptoms at ICF levels of activity and participation, and (iii) quantify the impact of daily engagement at the ICF level of participation on physical function. METHODS A secondary analysis was conducted using data from the parent study, which was a 2-group randomized trial involving persons with mild cognitive impairment and their informal caregivers participating in the Indiana Alzheimer Disease Center DEMA program. Quantitative analysis (dyads: DEMA N = 20, Information Support N = 20) examined outcomes at posttest and follow-up. Analysis employed linear regression to model the relationship between explanatory and dependent variables and independent t test to examine for difference in confidence, depression, and physical function. RESULTS AND DISCUSSION At posttest, change in self-rated performance predicted change in depressive symptoms. Those in the DEMA group who engaged in activity at the ICF level of participation demonstrated a significant increase in confidence and physical function. Although not significant, the control group posttest results showed a mean decrease in confidence. CONCLUSIONS Results demonstrate a positive impact of DEMA on depressive symptoms, confidence, and physical function. Change in occupational performance predicted change in depressive symptoms. Confidence significantly improved among those who engaged at the ICF participation level. A larger, randomized controlled longitudinal trial is needed to better assess the impact of DEMA on physical function, activity, participation restriction, and quality of life.",2019,Those in the DEMA group who engaged in activity at the ICF level of participation demonstrated a significant increase in confidence and physical function.,"['Nearly a quarter of those in the United States older than 71 years experience mild cognitive impairment', 'persons with mild cognitive impairment and their informal caregivers participating in the Indiana Alzheimer Disease Center DEMA program', 'Persons with mild cognitive impairment battle depression and progressive disengagement from daily activities', 'Older Adults With Mild Cognitive Impairment']",[],"['confidence and physical function', 'confidence', 'physical function, activity, participation restriction, and quality of life', 'Change in Depression, Confidence, and Physical Function', 'confidence and depressive symptoms at ICF levels of activity and participation, and (iii) quantify the impact of daily engagement at the ICF level of participation on physical function', 'depressive symptoms', 'depressive symptoms, confidence, and physical function', 'confidence, depression, and physical function']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1270972', 'cui_str': 'Mild Neurocognitive Disorder'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0002395', 'cui_str': 'Alzheimer Dementia'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0205329', 'cui_str': 'Progressive (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]",[],"[{'cui': 'C0237529', 'cui_str': 'Self Confidence'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0034380'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0444966', 'cui_str': 'ICF'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}]",,0.0795917,Those in the DEMA group who engaged in activity at the ICF level of participation demonstrated a significant increase in confidence and physical function.,"[{'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Ellis', 'Affiliation': 'Department of Physical Therapy, School of Health and Rehabilitation Sciences, Indiana University-Purdue University Indianapolis.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Altenburger', 'Affiliation': 'Department of Physical Therapy, School of Health and Rehabilitation Sciences, Indiana University-Purdue University Indianapolis.'}, {'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'Lu', 'Affiliation': 'Department of Science of Nursing Care, School of Nursing, Indiana University-Purdue University Indianapolis.'}]",Journal of geriatric physical therapy (2001),['10.1519/JPT.0000000000000143'] 756,31983658,"Efficacy and safety of ataluren in patients with nonsense-mutation cystic fibrosis not receiving chronic inhaled aminoglycosides: The international, randomized, double-blind, placebo-controlled Ataluren Confirmatory Trial in Cystic Fibrosis (ACT CF).","BACKGROUND Ataluren was developed for potential treatment of nonsense-mutation cystic fibrosis (CF). A previous phase 3 ataluren study failed to meet its primary efficacy endpoint, but post-hoc analyses suggested that aminoglycosides may have interfered with ataluren's action. Thus, this subsequent trial (NCT02139306) was designed to assess the efficacy and safety of ataluren in patients with nonsense-mutation CF not receiving aminoglycosides. METHODS Eligible subjects with nonsense-mutation CF (aged ≥6 years; percent predicted (pp) FEV 1 ≥40 and ≤90) from 75 sites in 16 countries were randomly assigned in double-blinded fashion to receive oral ataluren or matching placebo thrice daily for 48 weeks. The primary endpoint was absolute change in average ppFEV 1 from baseline to the average of Weeks 40 and 48. FINDINGS 279 subjects were enrolled; 138 subjects in the ataluren arm and 136 in the placebo arm were evaluable for efficacy. Absolute ppFEV 1 change from baseline did not differ significantly between the ataluren and placebo groups at Week 40 (-0.8 vs -1.8) or Week 48 (-1.7 vs -2.4). Average ppFEV 1 treatment difference from baseline to Weeks 40 and 48 was 0.6 (95% CI -1.3, 2.5; p = 0.54). Pulmonary exacerbation rate per 48 weeks was not significantly different (ataluren 0.95 vs placebo 1.13; rate ratio p = 0.40). Safety was similar between groups. No life-threatening adverse events or deaths were reported. INTERPRETATION Neither ppFEV 1 change nor pulmonary exacerbation rate over 48 weeks were statistically different between ataluren and placebo groups. Development of a nonsense-mutation CF therapy remains elusive.",2020,Neither ppFEV 1 change nor pulmonary exacerbation rate over 48 weeks were statistically different between ataluren and placebo groups.,"['Eligible subjects with nonsense-mutation CF (aged ≥6 years; percent predicted (pp) FEV 1 ≥40 and ≤90) from 75 sites in 16 countries', '279 subjects were enrolled; 138 subjects in the ataluren arm and 136 in the', 'patients with nonsense-mutation cystic fibrosis not receiving chronic inhaled aminoglycosides', 'nonsense-mutation cystic fibrosis (CF', 'patients with nonsense-mutation CF not receiving aminoglycosides', 'Cystic Fibrosis (ACT CF']","['placebo', 'oral ataluren or matching placebo']","['No life-threatening adverse events or deaths', 'efficacy and safety', 'Pulmonary exacerbation rate', 'pulmonary exacerbation rate', 'absolute change in average ppFEV', 'Efficacy and safety', 'Safety']","[{'cui': 'C0544885', 'cui_str': 'Nonsense mutation'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439165', 'cui_str': 'Percent (property) (qualifier value)'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C2930764', 'cui_str': 'ataluren'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C4517568', 'cui_str': 'One hundred and thirty-six'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0010674', 'cui_str': 'Mucoviscidosis'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0004048', 'cui_str': 'Inhalation'}, {'cui': 'C0002556', 'cui_str': 'Aminoglycosides'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C2930764', 'cui_str': 'ataluren'}, {'cui': 'C0336766', 'cui_str': 'Matches'}]","[{'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C4522268', 'cui_str': 'Pulmonary'}, {'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}]",279.0,0.749932,Neither ppFEV 1 change nor pulmonary exacerbation rate over 48 weeks were statistically different between ataluren and placebo groups.,"[{'ForeName': 'M W', 'Initials': 'MW', 'LastName': 'Konstan', 'Affiliation': ""Rainbow Babies and Children's Hospital, Cleveland, OH 44106 USA; Case Western Reserve University School of Medicine, Cleveland, OH 44106 USA. Electronic address: Michael.konstan@case.edu.""}, {'ForeName': 'D R', 'Initials': 'DR', 'LastName': 'VanDevanter', 'Affiliation': 'Case Western Reserve University School of Medicine, Cleveland, OH 44106 USA.'}, {'ForeName': 'S M', 'Initials': 'SM', 'LastName': 'Rowe', 'Affiliation': 'Pulmonary and Critical Care Medicine, University of Alabama at Birmingham, Birmingham, AL 35249 USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Wilschanski', 'Affiliation': 'Center for Cystic Fibrosis, Hadassah Hebrew University Medical Center, Jerusalem, 91240, Israel.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Kerem', 'Affiliation': 'Center for Cystic Fibrosis, Hadassah Hebrew University Medical Center, Jerusalem, 91240, Israel.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Sermet-Gaudelus', 'Affiliation': ""Centre de Ressource et de Competence de la Mucoviscidose, Service de Pediatrie Generale, Service de Pneumologie Pediatrique, Service de Radiologie Pediatrique, Centre d'Investigation Clinique Hôpital Necker - Enfants Malades, 75015 Paris, France.""}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'DiMango', 'Affiliation': 'Pulmonary, Allergy, and Critical Care Medicine, Columbia University, Department of Medicine, New York, NY 10032 USA.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Melotti', 'Affiliation': 'Centro Fibrosi Cistica, Azienda Ospedaliera Universitaria Integrata, Verona, Italy.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'McIntosh', 'Affiliation': 'PTC Therapeutics, South Plainfield, NJ 07080 USA.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'De Boeck', 'Affiliation': 'Pediatric Pulmonology and Infectious Diseases, University Hospital of Leuven, University of Leuven, Belgium.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of cystic fibrosis : official journal of the European Cystic Fibrosis Society,['10.1016/j.jcf.2020.01.007'] 757,31983093,A study on the efficacy of recombinant human endostatin combined with apatinib mesylate in patients with middle and advanced stage non-small cell lung cancer.,"PURPOSE To explore the clinical efficacy of recombinant human endostatin combined with apatinib mesylate in patients with middle and advanced non-small cell lung cancer (NSCLC). METHODS A total of 64 patients with middle and advanced NSCLC were randomly divided into the control group (n=32) and observation group (n=32). The patients in control group received paclitaxel monotherapy, while those in the observation group were treated with recombinant human endostatin combined with apatinib mesylate. The short-term efficacy, the lung function and levels of immunoglobulin and T lymphocyte subsets before and after treatment and the adverse drug reactions of patients were compared between the two groups. All patients were followed up for 5 years, and the survival rate in the two groups was observed. RESULTS The short-term efficacy and lung function in observation group were better than those in control group (p<0.05). Compared with those in the control group, the levels of immunoglobulin G (IgG), IgA, IgM, cluster of differentiation 3+ (CD3+), CD4+ and CD4+/CD8+ were increased, while the CD8+ level was lowered in the observation group (p<0.05). The rate of adverse drug reactions in the observation group was lower than that in the control group (p<0.05). The 5-year survival rate was significantly higher in the observation group than that in the control group (p<0.05). CONCLUSION Recombinant human endostatin combined with apatinib mesylate achieves a better therapeutic effect in the treatment of middle and advanced NSCLC, with improved immune resistance of patients and less side effects. Therefore, it is worthy of popularization and application in clinical practice.",2019,"Compared with those in the control group, the levels of immunoglobulin G (IgG), IgA, IgM, cluster of differentiation 3+ (CD3+), CD4+ and CD4+/CD8+ were increased, while the CD8+ level was lowered in the observation group (p<0.05).","['patients with middle and advanced non-small cell lung cancer (NSCLC', 'patients with middle and advanced stage non-small cell lung cancer', '64 patients with middle and advanced NSCLC']","['recombinant human endostatin combined with apatinib mesylate', 'paclitaxel monotherapy', 'Recombinant human endostatin combined with apatinib mesylate']","['5-year survival rate', 'rate of adverse drug reactions', 'survival rate', 'lung function and levels of immunoglobulin and T lymphocyte subsets', 'levels of immunoglobulin G (IgG), IgA, IgM, cluster of differentiation 3+ (CD3+), CD4+ and CD4+/CD8', 'CD8+ level', 'short-term efficacy and lung function']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}]","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0534628', 'cui_str': 'Endostatins'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C4547969', 'cui_str': 'apatinib mesylate'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}]","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0041755', 'cui_str': 'Drug Side Effects'}, {'cui': 'C0024119', 'cui_str': 'Lung Function Tests'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0021027', 'cui_str': 'Immune Globulins'}, {'cui': 'C0080202', 'cui_str': 'T-Cell Subsets'}, {'cui': 'C0202087', 'cui_str': 'Immunoglobulin G measurement (procedure)'}, {'cui': 'C0020835', 'cui_str': 'Immunoglobulin A'}, {'cui': 'C0020861', 'cui_str': 'IgM'}, {'cui': 'C3179739', 'cui_str': '(LaCit2)3+'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}]",64.0,0.0263322,"Compared with those in the control group, the levels of immunoglobulin G (IgG), IgA, IgM, cluster of differentiation 3+ (CD3+), CD4+ and CD4+/CD8+ were increased, while the CD8+ level was lowered in the observation group (p<0.05).","[{'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Zhao', 'Affiliation': 'Department of Thoracic Surgery, Cancer Hospital of China Medical University, Shenyang 110042, China.'}, {'ForeName': 'Haibing', 'Initials': 'H', 'LastName': 'Yu', 'Affiliation': ''}, {'ForeName': 'Tianci', 'Initials': 'T', 'LastName': 'Han', 'Affiliation': ''}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Tong', 'Affiliation': ''}, {'ForeName': 'Xiangyu', 'Initials': 'X', 'LastName': 'Zhu', 'Affiliation': ''}]",Journal of B.U.ON. : official journal of the Balkan Union of Oncology,[] 758,31983098,Efficacy of Bevacizumab Combined with Albumin-Bound Paclitaxel in the Treatment of Platinum-Resistant Recurrent Ovarian Cancer.,"PURPOSE To investigate the efficacy and safety of bevacizumab (BEV) combined with albumin-bound paclitaxel (ABP) in the treatment of platinum-resistant recurrent ovarian cancer. METHODS Eighty-six patients with platinum-resistant recurrent ovarian cancer admitted to our hospital from March 2014 to March 2016 were enrolled and randomly divided into two groups, namely, BEV + ABP group (n=43, treated with BEV combined with ABP) and ABP group (n=43, treated with ABP alone). Next, the clinical objective response rate (ORR), changes in serum carbohydrate antigen 125 (CA125) level and adverse reactions were compared between two groups. Additionally, the progression-free survival (PFS) and overall survival (OS) were observed and recorded after treatment. RESULTS The clinical ORR and disease control rate (DCR) were 86.0% (37/43) and 93.0% (40/43) in BEV + ABP group and 62.8% (27/43) and 79.1% (34/43) in ABP group, respectively. The clinical ORR of patients exhibited a statistically significant difference between two groups (p=0.025), which was overtly higher in BEV + ABP group than that in ABP group, while the DCR had no statistically significant difference between two groups (p=0.117). The serum CA125 level was evidently decreased in both groups after treatment (p<0.05) compared with that before treatment, but it displayed no statistically significant difference between two groups after treatment (p=0.220). The major adverse reactions of patients were myelosuppression, gastrointestinal reaction, alopecia, rash, fatigue and peripheral neurotoxicity. There was no statistically significant difference in the incidence rate of adverse reactions between two groups (p>0.05). All patients were followed up for 6-29 months. The median OS of patients was 16.3 months and 12.6 months in BEV + ABP group and ABP group, respectively, which was clearly longer in BEV + ABP group than that in ABP group (p=0.007). The median PFS in BEV + ABP group was obviously longer than that in ABP group (8.9 months vs. 6.7 months, p=0.028). CONCLUSIONS In comparison with ABP alone, BEV combined with ABP applied in the treatment of platinum-resistant recurrent ovarian cancer prominently improves the clinical efficacy, PFS and OS, with good tolerance of patients, which is worthy of popularization and application in clinical practice.",2019,There was no statistically significant difference in the incidence rate of adverse reactions between two groups (p>0.05).,"['Eighty-six patients with platinum-resistant recurrent ovarian cancer admitted to our hospital from March 2014 to March 2016', 'platinum-resistant recurrent ovarian cancer', 'Platinum-Resistant Recurrent Ovarian Cancer']","['BEV combined with ABP) and ABP', 'bevacizumab (BEV) combined with albumin-bound paclitaxel (ABP', 'ABP alone, BEV combined with ABP', 'ABP', 'BEV + ABP', 'Bevacizumab Combined with Albumin-Bound Paclitaxel']","['myelosuppression, gastrointestinal reaction, alopecia, rash, fatigue and peripheral neurotoxicity', 'median PFS', 'clinical ORR and disease control rate (DCR', 'serum CA125 level', 'clinical objective response rate (ORR), changes in serum carbohydrate antigen 125 (CA125) level and adverse reactions', 'progression-free survival (PFS) and overall survival (OS', 'incidence rate of adverse reactions', 'clinical efficacy, PFS and OS', 'median OS']","[{'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C0332325', 'cui_str': 'Resistant (qualifier value)'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C1140680', 'cui_str': 'Ovary Cancer'}]","[{'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C1961039', 'cui_str': 'paclitaxel protein-bound'}]","[{'cui': 'C0854467', 'cui_str': 'Myelosuppression (finding)'}, {'cui': 'C0443286', 'cui_str': 'Reaction (qualifier value)'}, {'cui': 'C0002170', 'cui_str': 'Hair Loss'}, {'cui': 'C0015230', 'cui_str': 'Skin Rash'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0205100', 'cui_str': 'Peripheral (qualifier value)'}, {'cui': 'C0235032', 'cui_str': 'Neurotoxin Diseases'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0006610', 'cui_str': 'Mucin-16'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction (disorder)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0087113', 'cui_str': 'Treatment Efficacy'}]",86.0,0.0403636,There was no statistically significant difference in the incidence rate of adverse reactions between two groups (p>0.05).,"[{'ForeName': 'Biao', 'Initials': 'B', 'LastName': 'Liu', 'Affiliation': 'Department of Obstetrics and Gynecology, Shanxian Central Hospital, Heze, China.'}, {'ForeName': 'Ran', 'Initials': 'R', 'LastName': 'An', 'Affiliation': ''}, {'ForeName': 'Jianwei', 'Initials': 'J', 'LastName': 'Yu', 'Affiliation': ''}]",Journal of B.U.ON. : official journal of the Balkan Union of Oncology,[] 759,31984598,"Efficacy and tolerability of tirzepatide, a dual glucose-dependent insulinotropic peptide and glucagon-like peptide-1 receptor agonist in patients with type 2 diabetes: A 12-week, randomized, double-blind, placebo-controlled study to evaluate different dose-escalation regimens.","AIM To assess the efficacy and tolerability of tirzepatide treatment using three different dose-escalation regimens in patients with type 2 diabetes. MATERIALS AND METHODS In this double-blind, placebo-controlled study, patients were randomized (1:1:1:1) to receive either once-weekly subcutaneous tirzepatide or placebo. The tirzepatide dose groups and dose-escalation regimens were: 12 mg (4 mg weeks 0-3; 8 mg weeks 4-7; 12 mg weeks 8-11), 15 mg-1 (2.5 mg weeks 0-1; 5 mg weeks 2-3; 10 mg weeks 4-7; 15 mg weeks 8-11) and 15 mg-2 (2.5 mg weeks 0-3; 7.5 mg weeks 4-7; 15 mg weeks 8-11). The primary objective was to compare tirzepatide with placebo in HbA1c change from baseline at 12 weeks. RESULTS Overall, 111 patients were randomized: placebo, 26; tirzepatide 12 mg, 29; tirzepatide 15 mg-1, 28; tirzepatide 15 mg-2, 28. The mean age was 57.4 years, HbA1c 8.4% and body mass index 31.9 kg/m 2 . At week 12, absolute HbA1c change from baseline (SE) was greater in the tirzepatide treatment groups compared with placebo (placebo, +0.2% [0.21]; 12 mg, -1.7% [0.19]; 15 mg-1, -2.0% [0.20]; 15 mg-2, -1.8% [0.19]). The incidence of nausea was: placebo, 7.7%; 12 mg group, 24.1%; 15 mg-1 group, 39.3%; 15 mg-2 group, 35.7%. Three patients discontinued the treatment because of adverse events, one from each of the placebo, 12 mg and 15 mg-1 groups. CONCLUSIONS Tirzepatide treatment for 12 weeks resulted in clinically significant reductions in HbA1c. This suggests that lower starting doses and smaller dose increments are associated with a more favourable side effect profile.",2020,"At Week 12, absolute HbA1c change from baseline (SE) was greater in tirzepatide treatment groups compared with placebo (placebo, +0.2% [0.21]; 12 mg, -1.7% [0.19]; 15 mg-1, -2.0% [0.20]; 15 mg-2, -1.8% [0.19]).","['111 patients were randomised', 'Patients with Type 2 Diabetes', 'Mean age was 57.4\u2009years, HbA1c 8.4%, and BMI 31.9 kg/m 2 ', 'patients with type 2 diabetes']","['Placebo', 'placebo (placebo', 'Tirzepatide, a Dual GIP and GLP-1 Receptor Agonist', 'tirzepatide', 'placebo', 'tirzepatide or placebo']","['incidence of nausea', 'efficacy and tolerability', 'Efficacy and Tolerability', 'absolute HbA1c change from baseline (SE']","[{'cui': 'C4517538', 'cui_str': '111 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C4517876', 'cui_str': '8.4'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1702020', 'cui_str': '37-epsilon-palmitoyl-Lys-GIP'}, {'cui': 'C0378073', 'cui_str': 'GLP-1 Receptor'}, {'cui': 'C0243192', 'cui_str': 'agonists'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]",111.0,0.266328,"At Week 12, absolute HbA1c change from baseline (SE) was greater in tirzepatide treatment groups compared with placebo (placebo, +0.2% [0.21]; 12 mg, -1.7% [0.19]; 15 mg-1, -2.0% [0.20]; 15 mg-2, -1.8% [0.19]).","[{'ForeName': 'Juan Pablo', 'Initials': 'JP', 'LastName': 'Frias', 'Affiliation': 'National Research Institute, Los Angeles California, United States.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Nauck', 'Affiliation': 'Diabetes Center Bochum-Hattingen, St Josef Hospital, Ruhr-University Bochum, Bochum, Germany.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Van', 'Affiliation': 'Diabetes Research Center, Tustin, California.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Benson', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana.'}, {'ForeName': 'Ross', 'Initials': 'R', 'LastName': 'Bray', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana.'}, {'ForeName': 'Xuewei', 'Initials': 'X', 'LastName': 'Cui', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana.'}, {'ForeName': 'Zvonko', 'Initials': 'Z', 'LastName': 'Milicevic', 'Affiliation': 'Eli Lilly and Company, Vienna, Austria.'}, {'ForeName': 'Shweta', 'Initials': 'S', 'LastName': 'Urva', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana.'}, {'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Haupt', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana.'}, {'ForeName': 'Deborah A', 'Initials': 'DA', 'LastName': 'Robins', 'Affiliation': 'Eli Lilly and Company, Indianapolis, Indiana.'}]","Diabetes, obesity & metabolism",['10.1111/dom.13979'] 760,31984623,Association of increased hepatic insulin clearance and change in serum triglycerides or β-hydroxybutyrate concentration via the sodium/glucose-cotransporter 2 inhibitor tofogliflozin.,"AIMS Obesity and hepatic fat accumulation diminish hepatic insulin clearance, which can cause hyperinsulinaemia. Sodium/glucose-cotransporter 2 inhibitors (SGLT2-is) improve insulin resistance and hyperinsulinaemia by weight loss via increased urinary glucose excretion in type 2 diabetes. However, there are few reports of the influence of SGLT2-is on hepatic insulin clearance. We examined the impact of an SGLT2-i on hepatic insulin clearance and explored the clinical influence associated with changes in hepatic insulin clearance via an SGLT2-i and the mechanism of the effects of SGLT2-i. MATERIALS AND METHODS Data were analysed from 419 patients with type 2 diabetes controlled by diet and exercise. Patients received a placebo or the SGLT2-i tofogliflozin (TOFO) (placebo: n = 56; TOFO: n = 363) orally once daily for ≥24 weeks. Hepatic insulin clearance was calculated from the ratio of areas under the curve (AUC) of C-peptide and insulin levels derived from oral meal tolerance test data (C-peptide AUC 0-120 min /insulin AUC 0-120 min : HIC CIR ). The correlation of HIC CIR via the SGLT2-i with other clinical variables was analysed using multivariate analysis. RESULTS HIC CIR was significantly increased via TOFO at week 24. Furthermore, with TOFO insulin and triglyceride (TG) levels were significantly reduced (P < 0.001) and β-hydroxybutyrate (BHB) was significantly elevated (P < 0.001). Changes in HIC CIR were significantly correlated with changes in TG and BHB via TOFO. CONCLUSIONS Increased HIC CIR was significantly associated with reduced TG via TOFO and contributed to the greater increase in BHB compared with placebo in addition to the correction of hyperinsulinaemia.",2020,"Furthermore, with TOFO insulin and triglyceride (TG) levels were significantly reduced (p <0.001) and β-hydroxybutyrate (BHB) was significantly elevated (p <0.001).","['419 patients with type 2 diabetes controlled by diet and exercise', 'type 2 diabetes']","['placebo', 'Sodium/glucose-cotransporter 2 inhibitors (SGLT2-is', 'SGLT2-i', 'placebo or the SGLT2-i tofogliflozin (TOFO) (placebo: n\xa0=\xa056; TOFO: n\xa0=\xa0363) orally once daily for ≥24\u2009weeks']","['TOFO insulin and triglyceride (TG) levels', 'β-hydroxybutyrate (BHB', 'Hepatic insulin clearance', 'HIC CIR', 'hepatic insulin clearance', 'BHB', 'hepatic insulin clearance and change in serum triglycerides or β-hydroxybutyrate concentration']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0332298', 'cui_str': 'Controlled by (attribute)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3541959', 'cui_str': 'Sodium supplement (substance)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C3501434'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0428475', 'cui_str': 'Triglyceride level - finding'}, {'cui': 'C0020332', 'cui_str': 'Hydroxybutyrates'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0542495', 'cui_str': 'Measurement of serum triglyceride level'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",419.0,0.0530782,"Furthermore, with TOFO insulin and triglyceride (TG) levels were significantly reduced (p <0.001) and β-hydroxybutyrate (BHB) was significantly elevated (p <0.001).","[{'ForeName': 'Yasuhiro', 'Initials': 'Y', 'LastName': 'Matsubayashi', 'Affiliation': 'Department of Hematology, Endocrinology and Metabolism, Faculty of Medicine, Niigata University, Niigata, Japan.'}, {'ForeName': 'Akihiro', 'Initials': 'A', 'LastName': 'Yoshida', 'Affiliation': 'Department of Hematology, Endocrinology and Metabolism, Faculty of Medicine, Niigata University, Niigata, Japan.'}, {'ForeName': 'Hideki', 'Initials': 'H', 'LastName': 'Suganami', 'Affiliation': 'Clinical Data Science Dept., Kowa Co., Ltd., Japan.'}, {'ForeName': 'Taeko', 'Initials': 'T', 'LastName': 'Osawa', 'Affiliation': 'Department of Hematology, Endocrinology and Metabolism, Faculty of Medicine, Niigata University, Niigata, Japan.'}, {'ForeName': 'Kazuo', 'Initials': 'K', 'LastName': 'Furukawa', 'Affiliation': 'Department of Hematology, Endocrinology and Metabolism, Faculty of Medicine, Niigata University, Niigata, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Suzuki', 'Affiliation': 'Department of Hematology, Endocrinology and Metabolism, Faculty of Medicine, Niigata University, Niigata, Japan.'}, {'ForeName': 'Kazuya', 'Initials': 'K', 'LastName': 'Fujihara', 'Affiliation': 'Department of Hematology, Endocrinology and Metabolism, Faculty of Medicine, Niigata University, Niigata, Japan.'}, {'ForeName': 'Shiro', 'Initials': 'S', 'LastName': 'Tanaka', 'Affiliation': 'Department of Clinical Biostatistics, Graduate School of Medicine, Kyoto University, Japan.'}, {'ForeName': 'Kohei', 'Initials': 'K', 'LastName': 'Kaku', 'Affiliation': 'Kawasaki Medical School, Okayama, Japan.'}, {'ForeName': 'Hirohito', 'Initials': 'H', 'LastName': 'Sone', 'Affiliation': 'Department of Hematology, Endocrinology and Metabolism, Faculty of Medicine, Niigata University, Niigata, Japan.'}]","Diabetes, obesity & metabolism",['10.1111/dom.13980'] 761,29436486,"Randomised, double-blind, placebo-controlled crossover study of single-dose guanfacine in unilateral neglect following stroke.","OBJECTIVE Unilateral neglect is a poststroke disorder that impacts negatively on functional outcome and lacks established, effective treatment. This multicomponent syndrome is characterised by a directional bias of attention away from contralesional space, together with impairments in several cognitive domains, including sustained attention and spatial working memory. This study aimed to test the effects of guanfacine, a noradrenergic alpha-2A agonist, on ameliorating aspects of neglect. METHODS Thirteen right hemisphere stroke patients with leftward neglect were included in a randomised, double-blind, placebo-controlled proof-of-concept crossover study that examined the effects of a single dose of guanfacine. Patients were tested on a computerised, time-limited cancellation paradigm, as well as tasks that independently assessed sustained attention and spatial working memory. RESULTS On guanfacine, there was a statistically significant improvement in the total number of targets found on the cancellation task when compared with placebo (mean improvement of 5, out of a possible 64). However, there was no evidence of a change in neglect patients' directional attention bias. Furthermore, Bayesian statistical analysis revealed reliable evidence against any effects of guanfacine on search organisation and performance on our sustained attention and spatial working memory tasks. CONCLUSIONS Guanfacine improves search in neglect by boosting the number of targets found but had no effects on directional bias or search organisation, nor did it improve sustained attention or working memory on independent tasks. Further work is necessary to determine whether longer term treatment with guanfacine may be effective for some neglect patients and whether it affects functional outcome measures. TRIAL REGISTRATION NUMBER NCT00955253.",2018,"On guanfacine, there was a statistically significant improvement in the total number of targets found on the cancellation task when compared with placebo (mean improvement of 5, out of a possible 64).","['Thirteen right hemisphere stroke patients with leftward neglect', 'unilateral neglect following stroke']","['Guanfacine', 'placebo', 'guanfacine']","['sustained attention or working memory', 'total number of targets']","[{'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0205090', 'cui_str': 'Right (qualifier value)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0521874', 'cui_str': 'Victim of neglect'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}]","[{'cui': 'C0079466', 'cui_str': 'Guanfacine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}]",13.0,0.500093,"On guanfacine, there was a statistically significant improvement in the total number of targets found on the cancellation task when compared with placebo (mean improvement of 5, out of a possible 64).","[{'ForeName': 'Edwin S', 'Initials': 'ES', 'LastName': 'Dalmaijer', 'Affiliation': 'Department of Experimental Psychology, University of Oxford, Oxford, UK.'}, {'ForeName': 'Korina M S', 'Initials': 'KMS', 'LastName': 'Li', 'Affiliation': 'Centre for Restorative Neuroscience, Division of Brain Sciences, Imperial College London, London, UK.'}, {'ForeName': 'Nikos', 'Initials': 'N', 'LastName': 'Gorgoraptis', 'Affiliation': 'Centre for Restorative Neuroscience, Division of Brain Sciences, Imperial College London, London, UK.'}, {'ForeName': 'Alexander P', 'Initials': 'AP', 'LastName': 'Leff', 'Affiliation': 'Institute of Cognitive Neuroscience, University College London, London, UK.'}, {'ForeName': 'David L', 'Initials': 'DL', 'LastName': 'Cohen', 'Affiliation': 'Hyper-acute Stroke Unit, Northwick Park Hospital, London, UK.'}, {'ForeName': 'Andrew D', 'Initials': 'AD', 'LastName': 'Parton', 'Affiliation': 'Division of Psychology, Department of Life Sciences, Brunel University, Uxbridge, UK.'}, {'ForeName': 'Masud', 'Initials': 'M', 'LastName': 'Husain', 'Affiliation': 'Department of Experimental Psychology, University of Oxford, Oxford, UK.'}, {'ForeName': 'Paresh A', 'Initials': 'PA', 'LastName': 'Malhotra', 'Affiliation': 'Centre for Restorative Neuroscience, Division of Brain Sciences, Imperial College London, London, UK.'}]","Journal of neurology, neurosurgery, and psychiatry",['10.1136/jnnp-2017-317338'] 762,31978436,Perioperative prophylactic internal iliac artery balloon occlusion in the prevention of postpartum hemorrhage in placenta previa: a randomized controlled trial.,"BACKGROUND Placenta previa remains one of the major causes of massive postpartum hemorrhage and maternal mortality worldwide. OBJECTIVE To determine whether internal iliac artery balloon occlusion during cesarean delivery for placenta previa could reduce postpartum hemorrhage and other maternal complications. STUDY DESIGN This was a prospective randomized controlled trial conducted at a tertiary university obstetric unit in Hong Kong. Pregnant women who were diagnosed to have placenta previa at 34 weeks (defined as lower placenta edge within 2 cm from the internal os) and required cesarean delivery were invited to participate. Eligible pregnant women were randomized into internal iliac artery balloon occlusion (Occlusion) group or standard management (Control) group. Those randomized to the Occlusion group had internal iliac artery balloon catheter placement performed before cesarean delivery and then balloon inflation after delivery of the baby. The primary outcome was the reduction of postpartum hemorrhage in those with internal iliac artery balloon occlusion. Secondary outcome measures included hemoglobin drop after delivery; amount of blood product transfusion; incidence of hysterectomy; maternal complications including renal failure, ischemic liver, disseminated intravascular coagulation, and adult respiratory distress syndrome; length of stay in hospital; admission to intensive care unit; and maternal death. RESULTS Between May 2016 and September 2018, 40 women were randomized (20 in each group). Demographic and obstetric characteristics were similar between the 2 groups. In the Occlusion group, 3 women did not receive the scheduled procedure, as it was preceded by antepartum hemorrhage that required emergency cesarean delivery, and 1 woman had repeated scan at 36 weeks showing the placental edge was slightly more than 2 cm from the internal os. Intention-to-treat analysis found no significant differences between the Occlusion and the Control groups regarding to the median intraoperative blood loss (1451 [1024-2388] mL vs 1454 [888-2300] mL; P = .945), the median length of surgery (49 [30-62] min vs 37 [30-51] min; P = .204), or the need for blood transfusion during operation (57.9% vs 50.0%; P = .621). None of the patients had rebleeding after operation, complication related to internal iliac artery procedure, or any other maternal complications. Reanalyzing the data using on-treatment approach showed the same results. CONCLUSION The use of prophylactic internal iliac artery balloon occlusion in placenta previa patients undergoing cesarean delivery did not reduce postpartum hemorrhage or have any effect on maternal or neonatal morbidity.",2020,"None of the patients had rebleeding after operation, complication related to internal iliac artery procedure or any other maternal complications.","['ml vs 1454 (888-2300', 'tertiary university obstetric unit in Hong Kong', 'Eligible pregnant women', 'postpartum hemorrhage in placenta previa', 'Between May 2016 and Sep 2018, 40 women', 'placenta previa patients undergoing Cesarean delivery', 'Pregnant women who were diagnosed to have placenta previa at 34 weeks (defined as lower placenta edge within 2cm from the internal os) and required Cesarean delivery were invited to participate']","['Occlusion Group had internal iliac artery balloon catheter placement', 'internal iliac artery balloon occlusion (Occlusion) group or standard management (Control) group', 'internal iliac artery balloon occlusion', 'prophylactic internal iliac artery balloon occlusion', 'Perioperative prophylactic internal iliac artery balloon occlusion']","['hemoglobin drop after delivery, amount of blood product transfusion, incidence of hysterectomy, maternal complications including renal failure, ischemic liver, disseminated intravascular coagulation, adult respiratory distress syndrome, length of stay in hospital, admission to intensive care unit, and maternal death', 'median length of surgery', 'median intra-operative blood loss', 'reduction of postpartum hemorrhage in those with internal iliac artery balloon occlusion', 'postpartum hemorrhage', 'Demographic and obstetric characteristics', 'need for blood transfusion']","[{'cui': 'C0205372', 'cui_str': 'Tertiary (qualifier value)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0019907', 'cui_str': 'Hongkong'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0032797', 'cui_str': 'Postpartum Hemorrhage'}, {'cui': 'C0032046', 'cui_str': 'Placenta Previa'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1384674', 'cui_str': 'Deliveries by cesarean (finding)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0032043', 'cui_str': 'Placentome'}, {'cui': 'C0205154', 'cui_str': 'Along edge (qualifier value)'}, {'cui': 'C0227842', 'cui_str': 'Structure of internal os'}]","[{'cui': 'C0441597', 'cui_str': 'Occlusion - action (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0226364', 'cui_str': 'Structure of internal iliac artery'}, {'cui': 'C0441127', 'cui_str': 'Balloon dilatation catheter (physical object)'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0887842', 'cui_str': 'Balloon Occlusion'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0445202', 'cui_str': 'Prophylactic (qualifier value)'}]","[{'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C4318619', 'cui_str': 'Drop (unit of presentation)'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C0005841', 'cui_str': 'Blood Transfusion'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0020699', 'cui_str': 'Hysterectomy'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0035078', 'cui_str': 'Kidney Failure'}, {'cui': 'C0475224', 'cui_str': 'Ischemic (qualifier value)'}, {'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C0012739', 'cui_str': 'Consumption Coagulopathy'}, {'cui': 'C0035222', 'cui_str': 'ARDS, Human'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0583239', 'cui_str': 'Admission to intensive care unit (procedure)'}, {'cui': 'C3494405', 'cui_str': 'Maternal Death'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0032797', 'cui_str': 'Postpartum Hemorrhage'}, {'cui': 'C0226364', 'cui_str': 'Structure of internal iliac artery'}, {'cui': 'C0887842', 'cui_str': 'Balloon Occlusion'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}, {'cui': 'C1273858', 'cui_str': 'Transfusion Medicine'}]",40.0,0.221838,"None of the patients had rebleeding after operation, complication related to internal iliac artery procedure or any other maternal complications.","[{'ForeName': 'Simon Chun Ho', 'Initials': 'SCH', 'LastName': 'Yu', 'Affiliation': 'Department of Imaging and Interventional Radiology, The Chinese University of Hong Kong, Shatin, Hong Kong.'}, {'ForeName': 'Yvonne Kwun Yue', 'Initials': 'YKY', 'LastName': 'Cheng', 'Affiliation': 'Department of Obstetrics and Gynaecology, The Chinese University of Hong Kong, Shatin, Hong Kong.'}, {'ForeName': 'Wing Ting', 'Initials': 'WT', 'LastName': 'Tse', 'Affiliation': 'Department of Obstetrics and Gynaecology, The Chinese University of Hong Kong, Shatin, Hong Kong.'}, {'ForeName': 'Daljit Singh', 'Initials': 'DS', 'LastName': 'Sahota', 'Affiliation': 'Department of Obstetrics and Gynaecology, The Chinese University of Hong Kong, Shatin, Hong Kong.'}, {'ForeName': 'Man Yan', 'Initials': 'MY', 'LastName': 'Chung', 'Affiliation': 'Department of Obstetrics and Gynaecology, The Chinese University of Hong Kong, Shatin, Hong Kong.'}, {'ForeName': 'Simon Sin Man', 'Initials': 'SSM', 'LastName': 'Wong', 'Affiliation': 'Department of Imaging and Interventional Radiology, The Chinese University of Hong Kong, Shatin, Hong Kong.'}, {'ForeName': 'Oi Ka', 'Initials': 'OK', 'LastName': 'Chan', 'Affiliation': 'Department of Obstetrics and Gynaecology, The Chinese University of Hong Kong, Shatin, Hong Kong.'}, {'ForeName': 'Tak Yeung', 'Initials': 'TY', 'LastName': 'Leung', 'Affiliation': 'Department of Obstetrics and Gynaecology, The Chinese University of Hong Kong, Shatin, Hong Kong. Electronic address: tyleung@cuhk.edu.hk.'}]",American journal of obstetrics and gynecology,['10.1016/j.ajog.2020.01.024'] 763,31979567,Eff ectiveness of Teneligliptin as an Add-on in T2DM Patients not Controlled on Metformin and Glimepiride.,,2020,,[],"['Metformin and Glimepiride', 'Teneligliptin']",[],[],"[{'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0061323', 'cui_str': 'glimepiride'}, {'cui': 'C2981308'}]",[],,0.0134403,,"[{'ForeName': 'Pranjal', 'Initials': 'P', 'LastName': 'Kashiv', 'Affiliation': 'Narayan Medical College and Hospital, Sasaram.'}, {'ForeName': 'Jitendra', 'Initials': 'J', 'LastName': 'Kumar', 'Affiliation': 'Narayan Medical College and Hospital, Sasaram.'}]",The Journal of the Association of Physicians of India,[] 764,31868776,Preventing Postpartum Depression With Mindful Self-Compassion Intervention: A Randomized Control Study.,"Mindfulness and self-compassion are reported to have a preventive effects on depression and anxiety disorders. In the present study, we aimed to assess the effect of mindful self-compassion intervention on preventing postpartum depression in a group of symptomatic pregnant women. Participants were screened and assigned to the intervention and control groups randomly. A 6-week Internet-based Mindful Self-Compassion Program was used to train the participants. Multiple scales were used to assess depressive and anxiety symptoms, mindfulness, self-compassion, and mother and infant well-being. All assessments were performed at three time points: baseline, 3 months, and 1 year postpartum. Compared with the control group, the intervention group showed significant improvement in depressive and anxiety behaviors. In addition, the intervention group became more mindful and self-compassionate at 3 months and 1 year postpartum. More importantly, both mothers and infants experienced substantial improvement in well-being. Our findings indicate that mindful self-compassion intervention is effective in preventing postpartum depression and promoting mother and infant well-being.",2020,"In addition, the intervention group became more mindful and self-compassionate at 3 months and 1 year postpartum.",['symptomatic pregnant women'],"['Internet-based Mindful Self-Compassion Program', 'Mindful Self-Compassion Intervention', 'mindful self-compassion intervention']","['postpartum depression', 'depressive and anxiety symptoms, mindfulness, self-compassion, and mother and infant well-being', 'mindful and self-compassionate', 'depressive and anxiety behaviors']","[{'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0221074', 'cui_str': 'Postnatal Depression'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0021287', 'cui_str': 'Infant Well-Being'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}]",,0.0275551,"In addition, the intervention group became more mindful and self-compassionate at 3 months and 1 year postpartum.","[{'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Guo', 'Affiliation': 'Department of Obstetrics and Gynecology, Tianjin First Center Hospital, Tianjin, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': ''}, {'ForeName': 'Liping', 'Initials': 'L', 'LastName': 'Mu', 'Affiliation': ''}, {'ForeName': 'Zhao', 'Initials': 'Z', 'LastName': 'Ye', 'Affiliation': ''}]",The Journal of nervous and mental disease,['10.1097/NMD.0000000000001096'] 765,31973934,Comparison of effectiveness coolant spray and placebo in patients with acute ankle trauma prospective randomized controlled trial.,"INTRODUCTION Coolant spray application in musculoskeletal injuries is an effective and harmless method to treat pain and reduce functional limitation. This study assessed the clinical value of coolant spray application on patient comfort before and during the radiographic imaging process along with its early analgesic and anti-edema effects. METHODS A total of 155 patients, admitted to the emergency department between April 1, 2019, and June 31, 2019, were included in this study. The patients were randomly assigned to either a coolant spray or a saline spray (placebo) group. To the coolant spray group patients, Cryos ®Spray (Phyto Performance, Italy) was applied. To the placebo group patients, a normal saline solution in a bottle covered with white opaque paper and refrigerated at 4 °C was sprayed. Radiographic images of the patients were scored for appropriateness of the standard imaging characteristics. RESULTS The mean scores were 8.13 ± 1.8 and 6.58 ± 2.2 for the coolant spray and normal saline spray groups, respectively; the differences were statistically significant between the two groups (mean difference: -1.56, 95% CI:-2.20 to -0.92; p = .000). Patients with fractures on their radiographs and treated with coolant spray received higher scores than similar patients treated with normal saline spray (mean difference:-1.92, 95% CI:-3.28 to -0.55; p = .009). The proportion of patients requesting analgesic treatment before discharge was statistically lower in the coolant spray group compared to the normal saline group (p = .025). CONCLUSIONS The radiographic images taken after coolant spray intervention in patients with acute ankle trauma were more successful in showing the target structures.",2020,"The proportion of patients requesting analgesic treatment before discharge was statistically lower in the coolant spray group compared to the normal saline group (p = .025). ","['155 patients, admitted to the emergency department between April 1, 2019, and June 31, 2019, were included in this study', 'patients with acute ankle trauma']","['coolant spray or a saline spray (placebo', 'placebo', 'normal saline solution', 'normal saline spray', 'coolant spray']","['proportion of patients requesting analgesic treatment before discharge', 'mean scores']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0003086', 'cui_str': 'Regio tarsalis'}, {'cui': 'C0043251', 'cui_str': 'Trauma'}]","[{'cui': 'C4521772', 'cui_str': 'Spray'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1272683', 'cui_str': 'Requested'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",155.0,0.112359,"The proportion of patients requesting analgesic treatment before discharge was statistically lower in the coolant spray group compared to the normal saline group (p = .025). ","[{'ForeName': 'Sultan Tuna Akgol', 'Initials': 'STA', 'LastName': 'Gur', 'Affiliation': 'Department of Emergency Medicine, Faculty of Medicine, Ataturk University, Erzurum, Turkey. Electronic address: sultantuna@hotmail.com.'}, {'ForeName': 'Sinem', 'Initials': 'S', 'LastName': 'Dogruyol', 'Affiliation': 'Department of Emergency Medicine, Manisa Merkez Efendi State Hospital, Manisa, Turkey.'}, {'ForeName': 'Abdullah Osman', 'Initials': 'AO', 'LastName': 'Kocak', 'Affiliation': 'Department of Emergency Medicine, Faculty of Medicine, Ataturk University, Erzurum, Turkey.'}, {'ForeName': 'Ilker', 'Initials': 'I', 'LastName': 'Akbas', 'Affiliation': 'Department of Emergency Medicine, Bingol State Hospital, Bingol, Turkey.'}, {'ForeName': 'Kutsi', 'Initials': 'K', 'LastName': 'Tuncer', 'Affiliation': 'Orthopedics and Traumatology, Department of Orthopedics and Traumatology, Faculty of Medicine, Ataturk University, Erzurum, Turkey.'}, {'ForeName': 'Hatice', 'Initials': 'H', 'LastName': 'Karabulut', 'Affiliation': 'Department of Emergency Medicine, Faculty of Medicine, Ataturk University, Erzurum, Turkey.'}, {'ForeName': 'Zeynep', 'Initials': 'Z', 'LastName': 'Cakir', 'Affiliation': 'Department of Emergency Medicine, Faculty of Medicine, Ataturk University, Erzurum, Turkey.'}]",The American journal of emergency medicine,['10.1016/j.ajem.2019.12.054'] 766,31974070,Changes in causes of death and influence of therapeutic improvement over time in patients with heart failure and reduced ejection fraction.,"INTRODUCTION AND OBJECTIVES In patients with heart failure and reduced ejection fraction (HFrEF), several therapies have been proven to reduce mortality in clinical trials. However, there are few data on the effect of the use of evidence-based therapies on causes of death in clinical practice. METHODS This study included 2351 outpatients with HFrEF (< 40%) from 2 multicenter prospective registries: MUSIC (n=641, period: 2003-2004) and REDINSCOR I (n=1710, period: 2007-2011). Variables were recorded at inclusion and all patients were followed-up for 4 years. Causes of death were validated by an independent committee. RESULTS Patients in REDINSCOR I more frequently received beta-blockers (85% vs 71%; P <.001), mineralocorticoid antagonists (64% vs 44%; P <.001), implantable cardioverter-defibrillators (19% vs 2%; P <.001), and resynchronization therapy (7.2% vs 4.8%; P=.04). In these patients, sudden cardiac death was less frequent than in those in MUSIC (6.8% vs 11.4%; P <.001). After propensity score matching, we obtained 2 comparable populations differing only in treatments (575 vs 575 patients). In patients in REDINSCOR I, we found a lower risk of total mortality (HR, 0.70; 95%CI, 0.57-0.87; P=.001) and sudden cardiac death (sHR, 0.46; 95%CI, 0.30-0.70; P <.001), and a trend toward lower mortality due to end-stage HF (sHR, 0.73; 95%CI, 0.53-1.01; P=.059), without differences in other causes of death (sHR, 1.17; 95%CI, 0.78-1.75; P=.445), regardless of functional class. CONCLUSIONS In ambulatory patients with HFrEF, implementation of evidence-based therapies was associated with a lower risk of death, mainly due to a significant reduction in sudden cardiac death.",2020,"I more frequently received beta-blockers (85% vs 71%; P <.001), mineralocorticoid antagonists (64% vs 44%; P <.001), implantable cardioverter-defibrillators (19% vs 2%; P <.001), and resynchronization therapy (7.2% vs 4.8%; P=.04).","['2351 outpatients with HFrEF (< 40%) from 2 multicenter prospective registries: MUSIC (n=641, period: 2003-2004) and REDINSCOR I (n=1710, period: 2007-2011', 'patients with heart failure and reduced ejection fraction (HFrEF', 'Patients in REDINSCOR', 'patients with heart failure and reduced ejection fraction']",['beta-blockers'],"['mineralocorticoid antagonists', 'lower risk of total mortality', 'implantable cardioverter-defibrillators', 'sudden cardiac death']","[{'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}]","[{'cui': 'C0330390', 'cui_str': 'Beta (organism)'}]","[{'cui': 'C1579268', 'cui_str': 'Mineralocorticoid Antagonists'}, {'cui': 'C3538919', 'cui_str': 'Low risk (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0162589', 'cui_str': 'Implantable Cardioverter-Defibrillators'}, {'cui': 'C0085298', 'cui_str': 'Sudden Cardiac Death'}]",2351.0,0.405092,"I more frequently received beta-blockers (85% vs 71%; P <.001), mineralocorticoid antagonists (64% vs 44%; P <.001), implantable cardioverter-defibrillators (19% vs 2%; P <.001), and resynchronization therapy (7.2% vs 4.8%; P=.04).","[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Fernández-Vázquez', 'Affiliation': 'Servicio de Cardiología, Hospital Clínico Universitario Virgen de la Arrixaca, Universidad de Murcia, IMIB-Arrixaca, El Palmar, Murcia, Spain.'}, {'ForeName': 'Andreu', 'Initials': 'A', 'LastName': 'Ferrero-Gregori', 'Affiliation': 'Servicio de Cardiología, Hospital de la Santa Creu i Sant Pau, Universidad Autónoma de Barcelona, Barcelona, Spain; Centro de Investigación Biomédica en Red de Enfermedades Cardiovasculares, Madrid, Spain.'}, {'ForeName': 'Jesús', 'Initials': 'J', 'LastName': 'Álvarez-García', 'Affiliation': 'Servicio de Cardiología, Hospital de la Santa Creu i Sant Pau, Universidad Autónoma de Barcelona, Barcelona, Spain; Centro de Investigación Biomédica en Red de Enfermedades Cardiovasculares, Madrid, Spain.'}, {'ForeName': 'Inés', 'Initials': 'I', 'LastName': 'Gómez-Otero', 'Affiliation': 'Centro de Investigación Biomédica en Red de Enfermedades Cardiovasculares, Madrid, Spain; Servicio de Cardiología, Hospital Universitario de Santiago de Compostela, IDIS, Santiago de Compostela, A Coruña, Spain.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Vázquez', 'Affiliation': 'Centro de Investigación Biomédica en Red de Enfermedades Cardiovasculares, Madrid, Spain; Servicio de Cardiología, Hospital Universitario Puerta del Mar, Cádiz, Spain.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Delgado Jiménez', 'Affiliation': 'Centro de Investigación Biomédica en Red de Enfermedades Cardiovasculares, Madrid, Spain; Servicio de Cardiología, Hospital Universitario 12 de Octubre, Facultad de Medicina UCM, Madrid, Spain.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Worner Diz', 'Affiliation': 'Servicio de Cardiología, Hospital Universitari Arnau de Vilanova, IRBLleida, Lleida, Spain.'}, {'ForeName': 'Alfredo', 'Initials': 'A', 'LastName': 'Bardají', 'Affiliation': 'Servicio de Cardiología, Hospital Universitario Joan XXIII, Tarragona, Spain.'}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'García-Pavía', 'Affiliation': 'Centro de Investigación Biomédica en Red de Enfermedades Cardiovasculares, Madrid, Spain; Servicio de Cardiología, Hospital Universitario Puerta de Hierro Majadahonda, Majadahonda, Madrid, Spain; Facultad de Medicina, Universidad Francisco de Vitoria (UFV), Pozuelo de Alarcón, Madrid, Spain.'}, {'ForeName': 'Antoni', 'Initials': 'A', 'LastName': 'Bayés-Genís', 'Affiliation': 'Servicio de Cardiología, Hospital Universitari Germans Trias i Pujol, Badalona, Barcelona, Spain.'}, {'ForeName': 'José R', 'Initials': 'JR', 'LastName': 'González-Juanatey', 'Affiliation': 'Centro de Investigación Biomédica en Red de Enfermedades Cardiovasculares, Madrid, Spain; Servicio de Cardiología, Hospital Universitario de Santiago de Compostela, IDIS, Santiago de Compostela, A Coruña, Spain.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Cinca', 'Affiliation': 'Servicio de Cardiología, Hospital de la Santa Creu i Sant Pau, Universidad Autónoma de Barcelona, Barcelona, Spain; Centro de Investigación Biomédica en Red de Enfermedades Cardiovasculares, Madrid, Spain.'}, {'ForeName': 'Domingo A', 'Initials': 'DA', 'LastName': 'Pascual Figal', 'Affiliation': 'Servicio de Cardiología, Hospital Clínico Universitario Virgen de la Arrixaca, Universidad de Murcia, IMIB-Arrixaca, El Palmar, Murcia, Spain; Centro de Investigación Biomédica en Red de Enfermedades Cardiovasculares, Madrid, Spain; Centro Nacional de Investigaciones Cardiovasculares (CNIC), Madrid, Spain. Electronic address: dpascual@um.es.'}]",Revista espanola de cardiologia (English ed.),['10.1016/j.rec.2019.09.030'] 767,29496722,Calcium and vitamin D supplementation and increased risk of serrated polyps: results from a randomised clinical trial.,"OBJECTIVE Serrated lesions such as sessile serrated adenomas or polyps (SSA/Ps) are important colorectal cancer precursors, but aetiological factors for these lesions are largely unknown. We aimed to determine the effects of calcium and vitamin D supplementation on the incidence of serrated polyps (SPs) in general and hyperplastic polyps and SSA/Ps specifically. DESIGN Participants with one or more adenoma at baseline were randomised to receive 1200 mg/day of elemental calcium, 1000 IU/day of vitamin D 3 , both or neither agent. Treatment continued for 3 or 5 years, when risk of polyps was determined from surveillance colonoscopy (treatment phase). Outcomes after treatment ceased were also assessed (observational phase). Adjusted risk ratios (aRRs) of SPs were determined via multivariable generalised linear models. RESULTS SPs were diagnosed in 565 of 2058 (27.5%) participants during the treatment phase and 329/1108 (29.7%) during the observational phase. In total, 211 SSA/Ps were identified during follow-up. In the treatment phase, there was no effect of either calcium or vitamin D on incidence of SSA/Ps. However, during the later observational phase, we observed elevated risks of SSA/Ps associated with calcium alone and calcium+vitamin D treatment (aRR (95% CI): 2.65 (1.43 to 4.91) and 3.81 (1.25 to 11.64), respectively). CONCLUSION In a large multicentre chemoprevention study, we found evidence that calcium and vitamin D supplementation increased the risk of SSA/Ps. This appeared to be a late effect: 6-10 years after supplementation began. These possible risks must be weighed against the benefits of calcium and vitamin D supplementation. : Trial registration NUMBER: NCT00153816; Results.",2019,"Ps associated with calcium alone and calcium+vitamin D treatment (aRR (95% CI): 2.65 (1.43 to 4.91) and 3.81 (1.25 to 11.64), respectively). ","['Participants with one or more adenoma at baseline', 'serrated polyps (SPs) in general and hyperplastic polyps and SSA']","['calcium or vitamin D', 'calcium and vitamin D supplementation', 'Calcium and vitamin D supplementation', 'elemental calcium, 1000 IU/day of vitamin D 3 , both or neither agent']","['risk of serrated polyps', 'risk of SSA/Ps', 'Adjusted risk ratios (aRRs) of SPs']","[{'cui': 'C0001430', 'cui_str': 'Adenoma'}, {'cui': 'C3266123', 'cui_str': 'Serrated polyp (morphologic abnormality)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0333983', 'cui_str': 'Metaplastic polyp (morphologic abnormality)'}]","[{'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C1883310', 'cui_str': '1000 (qualifier value)'}, {'cui': 'C0439465', 'cui_str': 'IU/day'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0450442', 'cui_str': 'Agent (attribute)'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C3266123', 'cui_str': 'Serrated polyp (morphologic abnormality)'}, {'cui': 'C0028873', 'cui_str': 'Risk Ratio'}, {'cui': 'C4255078', 'cui_str': 'SPS'}]",,0.282579,"Ps associated with calcium alone and calcium+vitamin D treatment (aRR (95% CI): 2.65 (1.43 to 4.91) and 3.81 (1.25 to 11.64), respectively). ","[{'ForeName': 'Seth D', 'Initials': 'SD', 'LastName': 'Crockett', 'Affiliation': 'Division of Gastroenterology and Hepatology, University of North Carolina School of Medicine, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Elizabeth L', 'Initials': 'EL', 'LastName': 'Barry', 'Affiliation': 'Department of Epidemiology, Geisel School of Medicine at Dartmouth College, Hanover, New Hampshire, USA.'}, {'ForeName': 'Leila A', 'Initials': 'LA', 'LastName': 'Mott', 'Affiliation': 'Department of Epidemiology, Geisel School of Medicine at Dartmouth College, Hanover, New Hampshire, USA.'}, {'ForeName': 'Dennis J', 'Initials': 'DJ', 'LastName': 'Ahnen', 'Affiliation': 'Division of Gastroenterology, University of Colorado School of Medicine, Aurora Health Care, Denver, Colorado, USA.'}, {'ForeName': 'Douglas J', 'Initials': 'DJ', 'LastName': 'Robertson', 'Affiliation': 'Division of Gastroenterology and Hepatology, VA Medical Center, White River Junction, VT & Geisel School of Medicine at Dartmouth College, Hanover, New Hampshire, USA.'}, {'ForeName': 'Joseph C', 'Initials': 'JC', 'LastName': 'Anderson', 'Affiliation': 'Division of Gastroenterology and Hepatology, VA Medical Center, White River Junction, VT & Geisel School of Medicine at Dartmouth College, Hanover, New Hampshire, USA.'}, {'ForeName': 'Kristen', 'Initials': 'K', 'LastName': 'Wallace', 'Affiliation': 'Department of Public Health Sciences, Medical University of South Carolina, Charleston, South Carolina, USA.'}, {'ForeName': 'Carol A', 'Initials': 'CA', 'LastName': 'Burke', 'Affiliation': 'Department of Gastroenterology, Cleveland Clinic School of Medicine, Cleveland, Ohio, USA.'}, {'ForeName': 'Robert S', 'Initials': 'RS', 'LastName': 'Bresalier', 'Affiliation': 'Department of Gastroenterology, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Jane C', 'Initials': 'JC', 'LastName': 'Figueiredo', 'Affiliation': 'Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles, California, USA.'}, {'ForeName': 'Dale C', 'Initials': 'DC', 'LastName': 'Snover', 'Affiliation': 'Department of Pathology, Fairview Southdale Hospital, Edina, Minnesota, USA.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Baron', 'Affiliation': 'Division of Gastroenterology and Hepatology, University of North Carolina School of Medicine, Chapel Hill, North Carolina, USA.'}]",Gut,['10.1136/gutjnl-2017-315242'] 768,31981557,Effect of facility-based HIV self-testing on uptake of testing among outpatients in Malawi: a cluster-randomised trial.,"BACKGROUND HIV self-testing increases testing uptake in sub-Saharan Africa but scale-up is challenging because of resource constraints. We evaluated an HIV self-testing intervention integrated into high-burden outpatient departments in Malawi. METHODS In this cluster-randomised trial, we recruited participants aged 15 years or older from 15 outpatient departments at high-burden health facilities (including health centres, mission hospitals, and district hospitals) in central and southern Malawi. The trial was clustered at the health facility level. We used constrained randomisation to allocate each cluster (1:1:1) to one of the following groups: standard provider-initiated testing and counselling with no intervention (provider offered during consultations), optimised provider-initiated testing and counselling (with additional provider training and morning HIV testing), and facility-based HIV self-testing (Oraquick HIV self-test, group demonstration and distribution, and private spaces for interpretation and counselling). The primary outcome was the proportion of outpatients tested for HIV on the day of enrolment, measured through exit surveys with a sample of outpatients. Analyses were on an intention-to-treat basis. The trial is registered with ClinicalTrials.gov, NCT03271307, and Pan African Clinical Trials, PACTR201711002697316. FINDINGS Between Sept 12, 2017, and Feb 23, 2018, 5885 outpatients completed an exit survey-2097 in the HIV self-testing group, 1951 in the standard provider-initiated testing and counselling group, and 1837 in the optimised provider-initiated testing and counselling group. 1063 (51%) of 2097 patients in the HIV self-testing group had HIV testing on the same day as enrolment, compared with 248 (13%) of 1951 in the standard provider-initiated testing and counselling group and 261 (14%) of 1837 in the optimised provider-initiated testing and counselling group. The odds of same-day HIV testing were significantly higher in the facility-based HIV self-testing group compared with either standard provider-initiated testing and counselling (adjusted odds ratio 8·52, 95% CI 3·98-18·24) or optimised provider-initiated testing and counselling (6·29, 2·96-13·38). Around 4% of those tested in the standard provider-initiated testing and counselling and optimised provider-initiated testing and counselling groups felt coerced to test, and around 1% felt coerced to share test results. No coercion was reported in the facility-based HIV self-testing group. INTERPRETATION Facility-based HIV self-testing increased HIV testing among outpatients in Malawi, with a minimal risk of adverse events. Facility-based HIV self-testing should be considered for scale-up in settings with a high unmet need for HIV testing. FUNDING United States Agency for International Development.",2020,"The odds of same-day HIV testing were significantly higher in the facility-based HIV self-testing group compared with either standard provider-initiated testing and counselling (adjusted odds ratio 8·52, 95% CI 3·98-18·24) or optimised provider-initiated testing and counselling (6·29, 2·96-13·38).","['outpatients in Malawi, with a minimal risk of adverse events', 'participants aged 15 years or older from 15 outpatient departments at high-burden health facilities (including health centres, mission hospitals, and district hospitals) in central and southern Malawi', '5885 outpatients completed an exit survey-2097 in the HIV self-testing group, 1951 in the standard provider-initiated testing and counselling group, and 1837 in the optimised provider-initiated testing and counselling group', '1063 (51%) of 2097 patients in the HIV self-testing group had HIV testing on the same day as enrolment, compared with 248 (13%) of 1951 in the standard provider-initiated testing and counselling group and 261 (14%) of 1837 in the optimised provider-initiated testing and counselling group', 'outpatients in Malawi', 'high-burden outpatient departments in Malawi']","['facility-based HIV self-testing', 'standard provider-initiated testing and counselling with no intervention (provider offered during consultations), optimised provider-initiated testing and counselling (with additional provider training and morning HIV testing), and facility-based HIV self-testing (Oraquick HIV self-test, group demonstration and distribution, and private spaces for interpretation and counselling']",['proportion of outpatients tested for HIV'],"[{'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0024548', 'cui_str': 'Republic of Malawi'}, {'cui': 'C0547040', 'cui_str': 'Minimal (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0018704', 'cui_str': 'Health Facilities'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0475309', 'cui_str': 'Health center (environment)'}, {'cui': 'C0026219', 'cui_str': 'Missions'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0020006', 'cui_str': 'Hospitals, District'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0337094', 'cui_str': 'Exit (qualifier value)'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1321876', 'cui_str': 'Human immunodeficiency virus test (procedure)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]","[{'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0332170', 'cui_str': 'Morning (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0037775', 'cui_str': 'Distributions (qualifier value)'}, {'cui': 'C4521534', 'cui_str': 'US Military enlisted E1'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}, {'cui': 'C0459471', 'cui_str': 'Interpretation (attribute)'}]","[{'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}]",5885.0,0.0574598,"The odds of same-day HIV testing were significantly higher in the facility-based HIV self-testing group compared with either standard provider-initiated testing and counselling (adjusted odds ratio 8·52, 95% CI 3·98-18·24) or optimised provider-initiated testing and counselling (6·29, 2·96-13·38).","[{'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Dovel', 'Affiliation': 'Division of Infectious Diseases, University of California Los Angeles, Los Angeles, CA, USA; Partners in Hope, Lilongwe, Malawi. Electronic address: kdovel@mednet.ucla.edu.'}, {'ForeName': 'Frackson', 'Initials': 'F', 'LastName': 'Shaba', 'Affiliation': 'Partners in Hope, Lilongwe, Malawi.'}, {'ForeName': 'O Agatha', 'Initials': 'OA', 'LastName': 'Offorjebe', 'Affiliation': 'Department of Medicine and David Geffen School of Medicine, University of California Los Angeles, Los Angeles, CA, USA; School of Medicine, Charles R Drew University of Medicine and Science, Los Angeles, CA, USA.'}, {'ForeName': 'Kelvin', 'Initials': 'K', 'LastName': 'Balakasi', 'Affiliation': 'Partners in Hope, Lilongwe, Malawi.'}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Nyirenda', 'Affiliation': 'Partners in Hope, Lilongwe, Malawi.'}, {'ForeName': 'Khumbo', 'Initials': 'K', 'LastName': 'Phiri', 'Affiliation': 'Partners in Hope, Lilongwe, Malawi.'}, {'ForeName': 'Sundeep K', 'Initials': 'SK', 'LastName': 'Gupta', 'Affiliation': 'Division of Infectious Diseases, University of California Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Wong', 'Affiliation': 'USAID Global Health Bureau, Washington, DC, USA.'}, {'ForeName': 'Chi-Hong', 'Initials': 'CH', 'LastName': 'Tseng', 'Affiliation': 'Division of General Internal Medicine and Health Services Research, University of California Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Brooke E', 'Initials': 'BE', 'LastName': 'Nichols', 'Affiliation': 'Health Economics and Epidemiology Research Office, Department of Internal Medicine, School of Clinical Medicine, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa; Department of Global Health, School of Public Health, Boston University, Boston, MA, USA.'}, {'ForeName': 'Refiloe', 'Initials': 'R', 'LastName': 'Cele', 'Affiliation': 'Health Economics and Epidemiology Research Office, Department of Internal Medicine, School of Clinical Medicine, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Lungu', 'Affiliation': 'Partners in Hope, Lilongwe, Malawi.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Masina', 'Affiliation': 'Malawi Ministry of Health, HIV/AIDS Unit, Lilongwe, Malawi.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Coates', 'Affiliation': 'Division of Infectious Diseases, University of California Los Angeles, Los Angeles, CA, USA.'}, {'ForeName': 'Risa M', 'Initials': 'RM', 'LastName': 'Hoffman', 'Affiliation': 'Division of Infectious Diseases, University of California Los Angeles, Los Angeles, CA, USA.'}]",The Lancet. Global health,['10.1016/S2214-109X(19)30534-0'] 769,31982493,Systemic Treatment With Glucocorticoids Is Associated With Incident Hypoglycemia and Mortality: A Historical Prospective Analysis.,"PURPOSE The purpose of this study was to examine whether the increased glycemic variability associated with systemic glucocorticoid treatment is also associated with increased incidence of hypoglycemia. METHODS All patients discharged from internal medicine units between 2010 and 2013 were included in this retrospective analysis. Patients were assigned to 3 groups: Group 1: no steroids were prescribed;. Group 2: topical or inhaled steroids were prescribed with no systemic treatment; and Group 3: systemic steroids were prescribed, with or without topical or inhaled treatment. RESULTS A total of 45,272 patients were included in the study. Patients in Group 3 had significantly higher rates of hypoglycemia (10.9%) compared to patients in Group 2 (7.4%), and patients in Group 1 (7.3%). Patients with diabetes mellitus had higher rates of hypoglycemia compared to patients without diabetes mellitus (14.3% vs 4.9%) but exhibited similar trends in response to steroid treatment. Multivariate analysis showed that systemic steroids were associated with increased risk for hypoglycemia (odds ratio [OR] 1.513, 95% confidence interval [CI] 1.311-1.746, P <0.001). Hypoglycemia associated with systemic steroid treatment was also associated with increased risk of death (hazard ratio [HR] 2.328, 95% CI 1.931-2.807, P <0.001). Patients who were treated with systemic steroids but did not have hypoglycemia did not have higher mortality rates (HR 1.068, 95% CI 0.972-1.175, P = 0.171). CONCLUSION Treatment with systemic steroids is associated with increased hypoglycemia incidence during hospitalization. Patients treated with steroids that had incident hypoglycemia had a higher 1-year mortality risk compared to patients without hypoglycemia treated with steroids.",2020,"Multivariate analysis showed that systemic steroids were associated with increased risk for hypoglycemia (OR 1.513, 95% CI 1.311- 1.746, p<0.001).","['A total of 45,272 patients were included in the study', 'patients discharged from internal medicine units between 2010 and 2013', 'Patients with diabetes mellitus']","['systemic steroids', 'Systemic steroids were prescribed, with or without topical or inhaled treatment', 'Topical or inhaled steroids with no systemic treatment', 'glucocorticoids']","['incident hypoglycemia and mortality', 'hypoglycemia', 'risk of death', 'mortality rates', 'rates of hypoglycemia', 'year mortality risk', 'risk for hypoglycemia', 'Hypoglycemia', 'incident hypoglycemia', 'hypoglycemia incidence']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0030685', 'cui_str': 'Patient Discharge'}, {'cui': 'C0021782', 'cui_str': 'Internal Medicine'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}]","[{'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0038317', 'cui_str': 'Steroids'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0004048', 'cui_str': 'Inhalation'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C3540778', 'cui_str': 'Glucocorticoids'}]","[{'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205848', 'cui_str': 'Death Rate'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}]",45272.0,0.111291,"Multivariate analysis showed that systemic steroids were associated with increased risk for hypoglycemia (OR 1.513, 95% CI 1.311- 1.746, p<0.001).","[{'ForeName': 'Israel', 'Initials': 'I', 'LastName': 'Khanimov', 'Affiliation': 'Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Mona', 'Initials': 'M', 'LastName': 'Boaz', 'Affiliation': 'Department of Nutrition Sciences, Ariel University, Ariel, Israel.'}, {'ForeName': 'Mordechai', 'Initials': 'M', 'LastName': 'Shimonov', 'Affiliation': 'Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel; Department of Surgery ""A"", Edith Wolfson Medical Center, Holon, Israel.'}, {'ForeName': 'Julio', 'Initials': 'J', 'LastName': 'Wainstein', 'Affiliation': 'Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel; Diabetes Unit, Edith Wolfson Medical Center, Holon, Israel.'}, {'ForeName': 'Eyal', 'Initials': 'E', 'LastName': 'Leibovitz', 'Affiliation': 'Department of Internal Medicine ""A"", Yoseftal Hospital, Eilat, Israel. Electronic address: eyalle2@clalit.org.il.'}]",The American journal of medicine,['10.1016/j.amjmed.2019.12.026'] 770,31818699,"Apomorphine sublingual film for off episodes in Parkinson's disease: a randomised, double-blind, placebo-controlled phase 3 study.","BACKGROUND Many patients with Parkinson's disease have potentially disabling off episodes that are not predictably responsive to levodopa. In this study, we assessed the safety and efficacy of apomorphine sublingual film as an on-demand therapy for off episodes in patients with Parkinson's disease. METHODS This randomised, double-blind, placebo-controlled study was done by movement disorder specialists at 32 sites in the USA and one in Canada. Patients with Parkinson's disease who had 2 h or more of off time per day with predictable morning off periods, were responsive to levodopa, and were on stable doses of anti-parkinsonian medication were eligible. In an open-label titration phase, increasing doses of apomorphine sublingual film (10-35 mg) were administered until a tolerable full on response was achieved. Patients were then randomly assigned (1:1) with an interactive web-response system to receive the effective dose of apomorphine sublingual film or matching placebo in a 12-week, double-blind maintenance phase. Randomisation was not stratified, and the block size was four. All patients and study personnel were masked to treatment assignments. The primary endpoint was the in-clinic change from predose to 30 min post-dose in the Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part 3 (motor) score at week 12, analysed on a modified intention-to-treat population by use of a mixed-effect model for repeated measures. Safety analyses were done on all enrolled patients who received at least one dose of study medication. This trial is registered with ClinicalTrials.gov, NCT02469090. FINDINGS Between June 18, 2015, and Dec 11, 2017, 109 patients were enrolled and randomly assigned to receive apomorphine sublingual film (n=54) or placebo (n=55). All patients received the assigned study treatment, and 34 (63%) of 54 patients receiving apomorphine sublingual film and 46 (84%) of 55 receiving placebo completed the study. Least squares mean (SE) change from predose to 30 min post-dose in MDS-UPDRS part 3 score at week 12 was -11·1 (SE 1·46, 95% CI -14·0 to -8·2) with apomorphine sublingual film and -3·5 (1·29, -6·1 to -0·9) with placebo (difference -7·6, SE 1·96, 95% CI -11·5 to -3·7; p=0·0002). Mild-to-moderate oropharyngeal events were the most common side-effect, reported in 17 (31%) of 54 patients receiving apomorphine sublingual film and in four (7%) of 55 patients receiving placebo, leading to treatment discontinuation in nine (17%) patients treated with apomorphine and in one (2%) patient treated with placebo. Other treatment-emergent adverse events were transient nausea (in 15 [28%] patients receiving apomorphine sublingual film), somnolence (seven [13%]), and dizziness (five [9%]). Orthostatic hypotension, syncope, dyskinesia, hallucinations, prolongation of the QT interval, and impulse control disorders were infrequent (prevalence ≤2% of all patients) or did not occur. One patient treated with apomorphine sublingual film (with known cardiac risk factors) had a fatal cardiac arrest. INTERPRETATION Although nearly a third of patients discontinued treatment primarily because of oropharyngeal side-effects, apomorphine sublingual film provided an efficacious, on-demand treatment for off episodes for most patients with Parkinson's disease in this trial. The long-term safety and efficacy of apomorphine sublingual film are currently being investigated. FUNDING Cynapsus Therapeutics and Sunovion.",2020,"Orthostatic hypotension, syncope, dyskinesia, hallucinations, prolongation of the QT interval, and impulse control disorders were infrequent (prevalence ≤2% of all patients) or did not occur.","[""Parkinson's disease"", ""Patients with Parkinson's disease who had 2 h or more of off time per day with predictable morning off periods, were responsive to levodopa, and were on stable doses of anti-parkinsonian medication were eligible"", ""patients with Parkinson's disease"", 'enrolled patients who received at least one dose of study medication', 'movement disorder specialists at 32 sites in the USA and one in Canada', 'All patients received the assigned study treatment, and 34 (63%) of 54 patients receiving', 'Between June 18, 2015, and Dec 11, 2017, 109 patients']","['apomorphine sublingual film', 'apomorphine sublingual film or matching placebo', 'apomorphine', 'placebo', 'Apomorphine sublingual film']","['transient nausea', 'dizziness', 'fatal cardiac arrest', ""clinic change from predose to 30 min post-dose in the Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part 3 (motor) score"", 'safety and efficacy', 'Orthostatic hypotension, syncope, dyskinesia, hallucinations, prolongation of the QT interval, and impulse control disorders', 'somnolence', 'Mild-to-moderate oropharyngeal events']","[{'cui': 'C0030567', 'cui_str': 'Idiopathic Parkinson Disease'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0011744', 'cui_str': 'Hydrogen-2'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0439505', 'cui_str': 'per day'}, {'cui': 'C0332170', 'cui_str': 'Morning (qualifier value)'}, {'cui': 'C0205342', 'cui_str': 'Responsive (qualifier value)'}, {'cui': 'C0023570', 'cui_str': 'Levodopa'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0026650', 'cui_str': 'Movement Disorder Syndromes'}, {'cui': 'C0087009', 'cui_str': 'Specialists'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0003596', 'cui_str': 'Apomorphine'}, {'cui': 'C4521982', 'cui_str': 'Sublingual'}, {'cui': 'C4319646', 'cui_str': 'Film'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0205374', 'cui_str': 'Transitory (qualifier value)'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0018790', 'cui_str': 'Cardiac Arrest'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0439568', 'cui_str': 'Post-dose (qualifier value)'}, {'cui': 'C0026650', 'cui_str': 'Movement Disorder Syndromes'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C3639721', 'cui_str': 'UPDRS Panel'}, {'cui': 'C0265219', 'cui_str': 'Lissencephaly Syndrome, Miller-Dieker'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0020651', 'cui_str': 'Hypotension, Postural'}, {'cui': 'C0039070', 'cui_str': 'Fainting'}, {'cui': 'C1869094', 'cui_str': 'Dyskinesia (SMQ)'}, {'cui': 'C0018524', 'cui_str': 'Hallucinations'}, {'cui': 'C0429028', 'cui_str': 'QT interval feature'}, {'cui': 'C0021122', 'cui_str': 'Impulse Control Disorders'}, {'cui': 'C2830004', 'cui_str': 'Somnolence'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C1522409', 'cui_str': 'Oropharyngeal route (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}]",109.0,0.374256,"Orthostatic hypotension, syncope, dyskinesia, hallucinations, prolongation of the QT interval, and impulse control disorders were infrequent (prevalence ≤2% of all patients) or did not occur.","[{'ForeName': 'C Warren', 'Initials': 'CW', 'LastName': 'Olanow', 'Affiliation': 'Department of Neurology, Icahn School of Medicine at Mount Sinai, New York, NY, USA; Clintrex, Sarasota, FL, USA. Electronic address: warren.olanow@clintrex.com.'}, {'ForeName': 'Stewart A', 'Initials': 'SA', 'LastName': 'Factor', 'Affiliation': 'Department of Neurology, Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Alberto J', 'Initials': 'AJ', 'LastName': 'Espay', 'Affiliation': 'Department of Neurology and Rehabilitation Medicine, University of Cincinnati, Cincinnati, OH, USA.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Hauser', 'Affiliation': 'Department of Neurology, University of South Florida, Tampa, FL, USA.'}, {'ForeName': 'Holly A', 'Initials': 'HA', 'LastName': 'Shill', 'Affiliation': 'Barrow Neurological Institute, Phoenix, AZ, USA.'}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'Isaacson', 'Affiliation': ""Parkinson's Disease and Movement Disorders Center of Boca Raton, Boca Raton, FL, USA.""}, {'ForeName': 'Rajesh', 'Initials': 'R', 'LastName': 'Pahwa', 'Affiliation': 'University of Kansas Medical Center, University of Kansas, Kansas City, KS, USA.'}, {'ForeName': 'Mika', 'Initials': 'M', 'LastName': 'Leinonen', 'Affiliation': 'Clintrex, Sarasota, FL, USA.'}, {'ForeName': 'Parul', 'Initials': 'P', 'LastName': 'Bhargava', 'Affiliation': 'Sunovion, Marlborough, MA, USA.'}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Sciarappa', 'Affiliation': 'Sunovion, Marlborough, MA, USA.'}, {'ForeName': 'Bradford', 'Initials': 'B', 'LastName': 'Navia', 'Affiliation': 'Sunovion, Marlborough, MA, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Blum', 'Affiliation': 'Sunovion, Marlborough, MA, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Neurology,['10.1016/S1474-4422(19)30396-5'] 771,31831388,"Endovascular treatment versus standard medical treatment for vertebrobasilar artery occlusion (BEST): an open-label, randomised controlled trial.","BACKGROUND Previous randomised trials have shown an overwhelming benefit of mechanical thrombectomy for treating patients with stroke caused by large vessel occlusion of the anterior circulation. Whether endovascular treatment is beneficial for vertebrobasilar artery occlusion remains unknown. In this study, we aimed to investigate the safety and efficacy of endovascular treatment of acute strokes due to vertebrobasilar artery occlusion. METHODS We did a multicentre, randomised, open-label trial, with blinded outcome assessment of thrombectomy in patients presenting within 8 h of vertebrobasilar occlusion at 28 centres in China. Patients were randomly assigned (1:1) to endovascular therapy plus standard medical therapy (intervention group) or standard medical therapy alone (control group). The randomisation sequence was computer-generated and stratified by participating centres. Allocation concealment was implemented by use of sealed envelopes. The primary outcome was a modified Rankin scale (mRS) score of 3 or lower (indicating ability to walk unassisted) at 90 days, assessed on an intention-to-treat basis. The primary safety outcome was mortality at 90 days. Secondary safety endpoints included the rates of symptomatic intracranial haemorrhage, device-related complications, and other severe adverse events. The BEST trial is registered with ClinicalTrials.gov, NCT02441556. FINDINGS Between April 27, 2015, and Sept 27, 2017, we assessed 288 patients for eligibility. The trial was terminated early after 131 patients had been randomly assigned (66 patients to the intervention group and 65 to the control group) because of high crossover rate and poor recruitment. In the intention-to-treat analysis, there was no evidence of a difference in the proportion of participants with mRS 0-3 at 90 days according to treatment (28 [42%] of 66 patients in the intervention group vs 21 [32%] of 65 in the control group; adjusted odds ratio [OR] 1·74, 95% CI 0·81-3·74). Secondary prespecified analyses of the primary outcome, done to assess the effect of crossovers, showed higher rates of mRS 0-3 at 90 days in patients who actually received the intervention compared with those who received standard medical therapy alone in both per-protocol (28 [44%] of 63 patients with intervention vs 13 [25%] of 51 with standard therapy; adjusted OR 2·90, 95% CI 1·20-7·03) and as-treated (36 [47%] of 77 patients with intervention vs 13 [24%] of 54 with standard therapy; 3·02, 1·31-7·00) populations. The 90-day mortality was similar between groups (22 [33%] of 66 patients in the intervention vs 25 [38%] of 65 in the control group; p=0·54) despite a numerically higher prevalence of symptomatic intracranial haemorrhage in the intervention group. INTERPRETATION There was no evidence of a difference in favourable outcomes of patients receiving endovascular therapy compared with those receiving standard medical therapy alone. Results might have been confounded by loss of equipoise over the course of the trial, resulting in poor adherence to the assigned study treatment and a reduced sample size due to the early termination of the study. FUNDING Jiangsu Provincial Special Program of Medical Science.",2020,There was no evidence of a difference in favourable outcomes of patients receiving endovascular therapy compared with those receiving standard medical therapy alone.,"['vertebrobasilar artery occlusion (BEST', 'Between April 27, 2015, and Sept 27, 2017, we assessed 288 patients for eligibility', 'patients presenting within 8 h of vertebrobasilar occlusion at 28 centres in China', '131 patients', 'patients with stroke caused by large vessel occlusion of the anterior circulation']","['endovascular therapy', 'endovascular treatment', 'endovascular therapy plus standard medical therapy (intervention group) or standard medical therapy alone (control group', 'Endovascular treatment versus standard medical treatment']","['modified Rankin scale (mRS) score of 3 or lower (indicating ability to walk unassisted) at 90 days, assessed on an intention-to-treat basis', 'mortality', 'symptomatic intracranial haemorrhage', 'safety and efficacy', 'rates of symptomatic intracranial haemorrhage, device-related complications, and other severe adverse events', '90-day mortality']","[{'cui': 'C0003842', 'cui_str': 'Arteries'}, {'cui': 'C0441597', 'cui_str': 'Occlusion - action (qualifier value)'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0225990', 'cui_str': 'Large vessel'}, {'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy (procedure)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}]","[{'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0559964', 'cui_str': 'Ambulation ability'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C1626935', 'cui_str': 'Base'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0151699', 'cui_str': 'Intracranial Hemorrhage'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",288.0,0.210128,There was no evidence of a difference in favourable outcomes of patients receiving endovascular therapy compared with those receiving standard medical therapy alone.,"[{'ForeName': 'Xinfeng', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Department of Neurology, Jinling Hospital, Medical School of Nanjing University, Nanjing, China; Stroke Center and Department of Neurology, First Affiliated Hospital of University of Science and Technology of China, Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei, China. Electronic address: xfliu2@ustc.edu.cn.'}, {'ForeName': 'Qiliang', 'Initials': 'Q', 'LastName': 'Dai', 'Affiliation': 'Department of Neurology, Jinling Hospital, Medical School of Nanjing University, Nanjing, China.'}, {'ForeName': 'Ruidong', 'Initials': 'R', 'LastName': 'Ye', 'Affiliation': 'Department of Neurology, Jinling Hospital, Medical School of Nanjing University, Nanjing, China.'}, {'ForeName': 'Wenjie', 'Initials': 'W', 'LastName': 'Zi', 'Affiliation': 'Department of Neurology, Jinling Hospital, Medical School of Nanjing University, Nanjing, China; Department of Neurology, Xinqiao Hospital, Third Military Medical University, Chongqing, China.'}, {'ForeName': 'Yuxiu', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Medical Statistics, Jinling Hospital, Medical School of Nanjing University, Nanjing, China.'}, {'ForeName': 'Huaiming', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Department of Neurology, Jinling Hospital, Medical School of Nanjing University, Nanjing, China.'}, {'ForeName': 'Wusheng', 'Initials': 'W', 'LastName': 'Zhu', 'Affiliation': 'Department of Neurology, Jinling Hospital, Medical School of Nanjing University, Nanjing, China.'}, {'ForeName': 'Minmin', 'Initials': 'M', 'LastName': 'Ma', 'Affiliation': 'Department of Neurology, Jinling Hospital, Medical School of Nanjing University, Nanjing, China.'}, {'ForeName': 'Qin', 'Initials': 'Q', 'LastName': 'Yin', 'Affiliation': 'Department of Neurology, Jinling Hospital, Medical School of Nanjing University, Nanjing, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Li', 'Affiliation': 'Department of Neurology, Jinling Hospital, Medical School of Nanjing University, Nanjing, China.'}, {'ForeName': 'Xinying', 'Initials': 'X', 'LastName': 'Fan', 'Affiliation': 'Department of Neurology, Jinling Hospital, Medical School of Nanjing University, Nanjing, China.'}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Sun', 'Affiliation': 'Department of Neurology, Jinling Hospital, Medical School of Nanjing University, Nanjing, China.'}, {'ForeName': 'Yunfei', 'Initials': 'Y', 'LastName': 'Han', 'Affiliation': 'Department of Neurology, Jinling Hospital, Medical School of Nanjing University, Nanjing, China.'}, {'ForeName': 'Qiushi', 'Initials': 'Q', 'LastName': 'Lv', 'Affiliation': 'Department of Neurology, Jinling Hospital, Medical School of Nanjing University, Nanjing, China.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Liu', 'Affiliation': 'Department of Neurology, Jinling Hospital, Medical School of Nanjing University, Nanjing, China.'}, {'ForeName': 'Dong', 'Initials': 'D', 'LastName': 'Yang', 'Affiliation': 'Department of Neurology, Jinling Hospital, Medical School of Nanjing University, Nanjing, China.'}, {'ForeName': 'Zhonghua', 'Initials': 'Z', 'LastName': 'Shi', 'Affiliation': ""Department of Neurosurgery, 101th Hospital of the People's Liberation Army, Wuxi, China.""}, {'ForeName': 'Dequan', 'Initials': 'D', 'LastName': 'Zheng', 'Affiliation': ""Department of Neurology, 175th hospital of the People's Liberation Army, Affiliated Southeast Hospital of Xiamen University, Zhangzhou, China.""}, {'ForeName': 'Xiaorong', 'Initials': 'X', 'LastName': 'Deng', 'Affiliation': 'Department of Neurology, Hubei Zhongshan Hospital, Hubei, China.'}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Wan', 'Affiliation': 'Department of Neurology, Hubei Zhongshan Hospital, Hubei, China.'}, {'ForeName': 'Zhen', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Department of Neurology, Changsha Central Hospital, Changsha, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Geng', 'Affiliation': ""Department of Neurology, Zhejiang Provincial People's Hospital, Hangzhou, China.""}, {'ForeName': 'Xingyu', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Department of Neurology, Affiliated Zhongshan Hospital, Xiamen University, Xiamen, China.'}, {'ForeName': 'Zhiming', 'Initials': 'Z', 'LastName': 'Zhou', 'Affiliation': 'Department of Neurology, Yijishan Hospital of Wannan Medical College, Wuhu, China.'}, {'ForeName': 'Geng', 'Initials': 'G', 'LastName': 'Liao', 'Affiliation': ""Department of Neurology, Maoming People's Hospital, Maoming, China.""}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Jin', 'Affiliation': ""Department of Neurology, Lu'an Affiliated Hospital of Anhui Medical University, Lu'an, China.""}, {'ForeName': 'Yumin', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Neurology, Zhongnan Hospital of Wuhan University, Wuhan, China.'}, {'ForeName': 'Xintong', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': ""Department of Neurology, Guangdong No 2 Provincial People's Hospital, Guangzhou, China.""}, {'ForeName': 'Meng', 'Initials': 'M', 'LastName': 'Zhang', 'Affiliation': 'Department of Neurology, Research Institute of Surgery, Daping Hospital, Third Military Medical University, Chongqing, China.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Zhou', 'Affiliation': 'Department of Neurology, Nanjing First Hospital, Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Hongchao', 'Initials': 'H', 'LastName': 'Shi', 'Affiliation': 'Department of Neurology, Nanjing First Hospital, Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Yunfeng', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Neurology, Affiliated Hospital of Nantong University, Nantong, China.'}, {'ForeName': 'Fuqiang', 'Initials': 'F', 'LastName': 'Guo', 'Affiliation': ""Department of Neurology, Sichuan People's Hospital, Chengdu, China.""}, {'ForeName': 'Congguo', 'Initials': 'C', 'LastName': 'Yin', 'Affiliation': ""Department of Neurology, Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine, Hangzhou, China.""}, {'ForeName': 'Guozhong', 'Initials': 'G', 'LastName': 'Niu', 'Affiliation': ""Department of Neurology, Affiliated Hangzhou First People's Hospital, Zhejiang University School of Medicine, Hangzhou, China.""}, {'ForeName': 'Mei', 'Initials': 'M', 'LastName': 'Zhang', 'Affiliation': ""Department of Neurology, First People's Hospital of Huainan, Huainan, China.""}, {'ForeName': 'Xueli', 'Initials': 'X', 'LastName': 'Cai', 'Affiliation': 'Department of Neurology, Lishui Hospital of Zhejiang University, Lishui, China.'}, {'ForeName': 'Qiyi', 'Initials': 'Q', 'LastName': 'Zhu', 'Affiliation': ""Department of Neurology, Linyi People's Hospital, Linyi, China.""}, {'ForeName': 'Zhonglun', 'Initials': 'Z', 'LastName': 'Chen', 'Affiliation': 'Department of Neurology, Mianyang Central Hospital, Mianyang, China.'}, {'ForeName': 'Yingchun', 'Initials': 'Y', 'LastName': 'Liang', 'Affiliation': 'Department of Neurology, Taian City Central Hospital, Taian, China.'}, {'ForeName': 'Bing', 'Initials': 'B', 'LastName': 'Li', 'Affiliation': 'Department of Neurology, Yantai Yuhuangding Hospital, Yantai, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Lin', 'Affiliation': 'Department of Neurology, Fuzhou General Hospital of Nanjing Military Region, Fuzhou, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'Department of Radiology, Affiliated Hospital of Yangzhou University, Yangzhou University, Yangzhou, China.'}, {'ForeName': 'Haowen', 'Initials': 'H', 'LastName': 'Xu', 'Affiliation': 'Department of Intervention Neuroradiology, First Affiliated Hospital of Zhengzhou University, Zhengzhou, China.'}, {'ForeName': 'Xinmin', 'Initials': 'X', 'LastName': 'Fu', 'Affiliation': 'Department of Neurology, Xuzhou Central Hospital, Xuzhou, China.'}, {'ForeName': 'Wenhua', 'Initials': 'W', 'LastName': 'Liu', 'Affiliation': 'Department of Neurology, Wuhan No 1 Hospital, Wuhan, China.'}, {'ForeName': 'Xiguang', 'Initials': 'X', 'LastName': 'Tian', 'Affiliation': 'Department of Neurology, Chinese Armed Police Force Guangdong Armed Police Corps hospital, Guangzhou, China.'}, {'ForeName': 'Zili', 'Initials': 'Z', 'LastName': 'Gong', 'Affiliation': 'Department of Neurology, Xinqiao Hospital, Third Military Medical University, Chongqing, China.'}, {'ForeName': 'Haicun', 'Initials': 'H', 'LastName': 'Shi', 'Affiliation': ""Department of Neurology, Third People's Hospital of Yancheng, Yancheng, China.""}, {'ForeName': 'Chuanming', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': ""Department of Neurology, Shenzhen Nanshan People's Hospital and 6th Affiliated Hospital of Shenzhen University Health Science Center, Shenzhen, China.""}, {'ForeName': 'Penghua', 'Initials': 'P', 'LastName': 'Lv', 'Affiliation': ""Department of Interventional Radiology, Northern Jiangsu People's Hospital, Yangzhou, China.""}, {'ForeName': 'Zhonghai', 'Initials': 'Z', 'LastName': 'Tao', 'Affiliation': 'Department of Neurology, Second Affiliated Hospital of Xuzhou Medical University, Xuzhou, China.'}, {'ForeName': 'Liangfu', 'Initials': 'L', 'LastName': 'Zhu', 'Affiliation': ""Cerebrovascular Center, Henan Provincial People's Hospital, Zhengzhou University, Zhengzhou, China.""}, {'ForeName': 'Shiquan', 'Initials': 'S', 'LastName': 'Yang', 'Affiliation': ""Department of Neurology, 123rd Hospital of the People's Liberation Army, Bengbu, China.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Hu', 'Affiliation': 'Stroke Center and Department of Neurology, First Affiliated Hospital of University of Science and Technology of China, Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei, China.'}, {'ForeName': 'Pingzhou', 'Initials': 'P', 'LastName': 'Jiang', 'Affiliation': 'Department of Neurology, Yangzhou Hongquan Hospital, Yangzhou, China.'}, {'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Liebeskind', 'Affiliation': 'Neurovascular Imaging Research Core and University of California Los Angeles Stroke Center, Department of Neurology, University of California, Los Angeles, CA, USA.'}, {'ForeName': 'Vitor M', 'Initials': 'VM', 'LastName': 'Pereira', 'Affiliation': 'Department of Medical Imaging and Surgery, Toronto Western Hospital, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Leung', 'Affiliation': 'Department of Medicine and Therapeutics, Chinese University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Yan', 'Affiliation': 'Melbourne Brain Centre at the Royal Melbourne Hospital, University of Melbourne, Parkville, VIC, Australia.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Davis', 'Affiliation': 'Melbourne Brain Centre at the Royal Melbourne Hospital, University of Melbourne, Parkville, VIC, Australia.'}, {'ForeName': 'Gelin', 'Initials': 'G', 'LastName': 'Xu', 'Affiliation': 'Department of Neurology, Jinling Hospital, Medical School of Nanjing University, Nanjing, China.'}, {'ForeName': 'Raul G', 'Initials': 'RG', 'LastName': 'Nogueira', 'Affiliation': 'Department of Neurology, Neurosurgery and Radiology, Emory University School of Medicine, Atlanta, GA, USA. Electronic address: rnoguei@emory.edu.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Neurology,['10.1016/S1474-4422(19)30395-3'] 772,31983158,Comparison of 10-Day Course of Triple Therapy Versus 14-Day Course for Eradication of Helicobacter pylori Infection in an Indonesian Population: Double-Blinded Randomized Clinical Trial.,"OBJECTIVE The aim of this study was to compare the effectiveness of 10-day course of triple therapy versus a 14-day course in the treatment of H.pylori infection in an Indonesian population. METHODS A double-blinded randomized clinical trial was included patients, Indonesian population, with H.pylori infection conducted in Cipto Mangunkusumo Hospital, Jakarta; Cilincing District General Hospital, Jakarta; and West Nusa Tenggara General Hospital, Mataram, during October 2016 - April 2017. Patients were randomized to be given triple therapy as Rabeprazole 20 mg, Amoxicillin 1,000 mg, and Clarithromycin 500 mg twice daily, for 14 days or 10 days plus 4 days placebo. Eradication was evaluated with UBT at least 4 weeks after completion the therapy. RESULTS A total of 75 patients (38 in the 14-day group and 37 in the 10-day group) were included to the study. In the intention-to-threat analysis, eradication rate was 67.6% (95% CI. 52.5%-82.6%) for the 10-day group versus 86.8% (95% CI. 76.0%-97.5%) for the 14-day group (p = 0.046), whereas per protocol analysis obtained 73.5% (95% CI. 58.6%-88.3%) for the 10-day versus 91.9% (95% CI. 84.1%-99.6%) in the 14-day group (p = 0.039). Adverse events were not significantly different between the two groups. CONCLUSION A 14-day course was more effective than 10-day course of triple therapy as first-line for eradication of H.pylori infection in an Indonesian population.",2020,"Adverse events were not significantly different between the two groups. ","['75 patients (38 in the 14-day group and 37 in the 10-day group) were included to the study', 'patients, Indonesian population, with H.pylori infection conducted in Cipto Mangunkusumo Hospital, Jakarta; Cilincing District General Hospital, Jakarta; and West Nusa Tenggara General Hospital, Mataram, during October 2016 - April 2017']","['placebo', 'Rabeprazole 20 mg, Amoxicillin 1,000 mg, and Clarithromycin', 'Triple Therapy Versus', 'triple therapy']","['Eradication', 'Helicobacter pylori Infection', 'Adverse events', 'eradication rate']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0337900', 'cui_str': 'Indonesians (ethnic group)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0020008', 'cui_str': 'Hospitals, General'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0378482', 'cui_str': 'rabeprazole'}, {'cui': 'C0002645', 'cui_str': 'Amoxicillin'}, {'cui': 'C0055856', 'cui_str': 'Clarithromycin'}, {'cui': 'C0205174', 'cui_str': 'Triple (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0850666', 'cui_str': 'Infection caused by Helicobacter pylori'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",75.0,0.32166,"Adverse events were not significantly different between the two groups. ","[{'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Herardi', 'Affiliation': 'Department of Internal Medicine, Faculty of Medicine, Universitas Indonesia, Cipto Mangunkusumo Hospital, Jakarta, Indonesia.'}, {'ForeName': 'Ari Fahrial', 'Initials': 'AF', 'LastName': 'Syam', 'Affiliation': 'Division of Gastroenterology, Department of Internal Medicine, Faculty of Medicine, Universitas Indonesia, Cipto Mangunkusumo Hospital, Jakarta, Indonesia.'}, {'ForeName': 'Marcellus', 'Initials': 'M', 'LastName': 'Simadibrata', 'Affiliation': 'Division of Gastroenterology, Department of Internal Medicine, Faculty of Medicine, Universitas Indonesia, Cipto Mangunkusumo Hospital, Jakarta, Indonesia.'}, {'ForeName': 'Siti', 'Initials': 'S', 'LastName': 'Setiati', 'Affiliation': 'Clinical Epidemiology Unit, Department of Internal Medicine, Faculty of Medicine, Universitas Indonesia, Cipto Mangunkusumo Hospital, Jakarta, Indonesia.'}, {'ForeName': 'Nikko', 'Initials': 'N', 'LastName': 'Darnindro', 'Affiliation': 'Cilincing District General Hospital, Jakarta, Indonesia.'}, {'ForeName': 'Murdani', 'Initials': 'M', 'LastName': 'Abdullah', 'Affiliation': 'Division of Gastroenterology, Department of Internal Medicine, Faculty of Medicine, Universitas Indonesia, Cipto Mangunkusumo Hospital, Jakarta, Indonesia.'}, {'ForeName': 'Dadang', 'Initials': 'D', 'LastName': 'Makmun', 'Affiliation': 'Division of Gastroenterology, Department of Internal Medicine, Faculty of Medicine, Universitas Indonesia, Cipto Mangunkusumo Hospital, Jakarta, Indonesia.'}]",Asian Pacific journal of cancer prevention : APJCP,['10.31557/APJCP.2020.21.1.19'] 773,31983177,"Efficacy and Safety of Metronomic Chemotherapy Versus Palliative Hydroxyurea in Unfit Acute Myeloid Leukemia Patients: A Multicenter, Open-Label Randomized Controlled Trial.","BACKGROUND Management of unfit AML patients is a therapeutic challenge. Most hematologists tend to avoid aggressive treatment leaving patients with a choice of best supportive care. We hypothesized that metronomic chemotherapy could be an alternative treatment for unfit AML patients. METHODS A multi-center randomized controlled trial was conducted in seven university-affiliated hospitals in Thailand. Unfit AML patients were recruited and followed up from December 2014 to December 2017. Patients were randomly assigned to receive either metronomic chemotherapy or palliative hydroxyurea. Overall survival rates were compared using Cox's proportional hazard survival analysis. RESULTS A total of 81 eligible patients were randomly allocated and included for ITT analysis. The OS rate was higher in group receiving metronomic chemotherapy than in group receiving palliative treatment at 6 and 12 months with borderline significance (6 months HR 0.60; 95%CI 0.36, 1.02; p-value 0.060; 12 months: HR 0.66; 95%CI 0.41, 1.08; p-value 0.097). CONCLUSION Metronomic chemotherapy could prolong survival time of unfit AML patients, especially in the first 12 months after diagnosis without increasing treatment-associated adverse events.",2020,"The OS rate was higher in group receiving metronomic chemotherapy than in group receiving palliative treatment at 6 and 12 months with borderline significance (6 months HR 0.60; 95%CI 0.36, 1.02; p-value 0.060; 12 months: HR 0.66; 95%CI 0.41, 1.08; p-value 0.097). ","['seven university-affiliated hospitals in Thailand', 'unfit AML patients', 'Unfit Acute Myeloid Leukemia Patients', 'Unfit AML patients were recruited and followed up from December 2014 to December 2017', 'A total of 81 eligible patients']","['metronomic chemotherapy or palliative hydroxyurea', 'Metronomic Chemotherapy Versus Palliative Hydroxyurea', 'metronomic chemotherapy', 'Metronomic chemotherapy']","['OS rate', 'survival time', 'Overall survival rates', 'Efficacy and Safety']","[{'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0039725', 'cui_str': 'Kingdom of Thailand'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0023467', 'cui_str': 'Nonlymphoblastic Leukemia, Acute'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]","[{'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C1285530', 'cui_str': 'Palliative'}, {'cui': 'C0020402', 'cui_str': 'hydroxyurea'}]","[{'cui': 'C2919552', 'cui_str': 'Survival time'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",81.0,0.201944,"The OS rate was higher in group receiving metronomic chemotherapy than in group receiving palliative treatment at 6 and 12 months with borderline significance (6 months HR 0.60; 95%CI 0.36, 1.02; p-value 0.060; 12 months: HR 0.66; 95%CI 0.41, 1.08; p-value 0.097). ","[{'ForeName': 'Saranya', 'Initials': 'S', 'LastName': 'Pongudom', 'Affiliation': 'Division of Hematology, Department of Internal Medicine, Udon Thani Hospital, Udon Thani, Thailand.'}, {'ForeName': 'Phichayut', 'Initials': 'P', 'LastName': 'Phinyo', 'Affiliation': 'Center for Clinical Epidemiology and Clinical Statistics, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand.'}, {'ForeName': 'Yingyong', 'Initials': 'Y', 'LastName': 'Chinthammitr', 'Affiliation': 'Division of Hematology, Department of Internal Medicine, Faculty of Medicine Siriraj Hospital, Bangkok, Thailand.'}, {'ForeName': 'Kanyaporn', 'Initials': 'K', 'LastName': 'Charoenprasert', 'Affiliation': 'Division of Hematology, Department of Internal Medicine, Si Sa Ket Hospital, Si Sa Ket, Thailand.'}, {'ForeName': 'Harutaya', 'Initials': 'H', 'LastName': 'Kasyanan', 'Affiliation': 'Division of Hematology, Department of Internal Medicine, Buddhachinaraj, Hospital, Phitsanulok,Thailand.'}, {'ForeName': 'Klaijith', 'Initials': 'K', 'LastName': 'Wongyai', 'Affiliation': 'Division of Hematology, Department of Internal Medicine, Sawanpracharak Hospital, Nakhon Sawan,Thailand.'}, {'ForeName': 'Jittiporn', 'Initials': 'J', 'LastName': 'Purattanamal', 'Affiliation': 'Division of Hematology, Department of Internal Medicine, Maharaj Nakhon Si Thammarat Hospital, Nakhon Si Thammarat,Thailand.'}, {'ForeName': 'Naiyana', 'Initials': 'N', 'LastName': 'Panoi', 'Affiliation': 'Division of Hematology, Department of Internal Medicine, Chonburi Hospital, Chon Buri, Thailand.'}, {'ForeName': 'Anoree', 'Initials': 'A', 'LastName': 'Surawong', 'Affiliation': 'Division of Hematology, Department of Internal Medicine, Sanprasithiprasong Hospital, Ubon Ratchathani, Thailand.'}]",Asian Pacific journal of cancer prevention : APJCP,['10.31557/APJCP.2020.21.1.147'] 774,31983186,The Effect of Prostate Cancer Educational Program on the level of Knowledge and Intention to Screen among Jordanian Men in Amman.,"PURPOSE The purpose of this study was to examine the effect of prostate cancer educational program on the level of knowledge and intention to screen for prostate cancer among Jordanian men in Amman. METHODS A quasi-experimental, with nonequivalent control group design was used. 154 participants were randomly assigned to the intervention and control groups.  Level of Knowledge and intention to screen were measured at baseline and at 1 month after the application of the prostate cancer educational program. Independent sample t-test was used to analyze the data. RESULTS The results showed statistically significant change in the mean knowledge scores (8.7), p < 0.001 and the mean of intention to screen scores (3.71), p < 0.001, after 1 month from the application of the educational program in the experimental group compared to the control group. CONCLUSION Implementing prostate cancer educational programs help enhance knowledge and intention to screen among Jordanian men.",2020,"The results showed statistically significant change in the mean knowledge scores (8.7), p < 0.001 and the mean of intention to screen scores (3.71), p < 0.001, after 1 month from the application of the educational program in the experimental group compared to the control group. ","['prostate cancer among Jordanian men in Amman', 'Jordanian Men in Amman', '154 participants', 'Jordanian men']","['Prostate Cancer Educational Program', 'prostate cancer educational program']","['mean knowledge scores', 'Level of Knowledge and intention to screen', 'mean of intention to screen scores', 'level of Knowledge and Intention to Screen']","[{'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}]",154.0,0.0187826,"The results showed statistically significant change in the mean knowledge scores (8.7), p < 0.001 and the mean of intention to screen scores (3.71), p < 0.001, after 1 month from the application of the educational program in the experimental group compared to the control group. ","[{'ForeName': 'Ahmad M', 'Initials': 'AM', 'LastName': 'Saleh', 'Affiliation': 'Prince Sattam Bin Abdulaziz University, College of Applied Medical Sciences, Department of Nursing, Alkharj, Riyadh, Saudi Arabia.'}, {'ForeName': 'Elturabi Elsayed', 'Initials': 'EE', 'LastName': 'Ebrahim', 'Affiliation': 'Prince Sattam Bin Abdulaziz University, College of Applied Medical Sciences, Department of Nursing, Alkharj, Riyadh, Saudi Arabia.'}, {'ForeName': 'Eid Hamed', 'Initials': 'EH', 'LastName': 'Aldossary', 'Affiliation': 'Prince Sattam Bin Abdulaziz University, College of Applied Medical Sciences, Department of Nursing, Alkharj, Riyadh, Saudi Arabia.'}, {'ForeName': 'Mariam Awad Mazyad', 'Initials': 'MAM', 'LastName': 'Almutairi', 'Affiliation': 'Prince Sattam Bin Abdulaziz University, College of Applied Medical Sciences, Department of Nursing, Alkharj, Riyadh, Saudi Arabia.'}]",Asian Pacific journal of cancer prevention : APJCP,['10.31557/APJCP.2020.21.1.211'] 775,31971832,Effects of functional training and 2 interdisciplinary interventions on maximal oxygen uptake and weight loss of women with obesity: a randomized clinical trial.,"Our aim was to analyze and compare functional training, interdisciplinary therapy, and interdisciplinary education on cardiorespiratory fitness (CF) and anthropometric characteristics of women with obesity. Forty-four women (age = 39.7 ± 5.9 years, body mass index (BMI) = 35.5 ± 2.8 kg/m 2 ) completed 30 weeks of intervention randomly assigned to 3 groups: functional training (FT) ( n = 14), interdisciplinary therapy (IT) ( n = 19), and interdisciplinary education (IE) ( n = 11). The FT group participated in the training program (3/week), the IT group received the same training intervention plus nutrition (1/week) and psychology advice (1/week) and physical therapy (1/week). The IE group participated in interdisciplinary lectures on topics related to health promotion (1/month). CF (ergospirometry), anthropometry, and body composition (electrical bioimpedance) were measured pre-intervention (Pre) and post-intervention (Post). CF increased ( p ≤ 0.05) significantly (Pre vs. Post) in the FT (7.5%) and IT (10.8%) groups, but not in the IE group (1.8%). Body mass (BM), BMI, relative fat mass, and waist circumference significantly ( p ≤ 0.05) decreased (Pre vs. Post) in IT (-4.4%, -4.4%, -2.3%, and -5.1%, respectively). The IE group showed a significant decrease in BM (-3.7%), BMI (-3.7%), and waist circumference (-3.5%), whereas the FT group promoted significant decrease in waist circumference (-3.4%). In conclusion, functional training increased CF but only interdisciplinary interventions improved the anthropometric profile of women with obesity. Novelty Interdisciplinary therapy provided more comprehensive adaptations in women with obesity, including morphological variables and CF. Functional training increased CF but reduced only abdominal obesity. Interdisciplinary education provided benefits on morphological variables, but it does not increase CF.",2020,"IE showed a significant decrease in BM (-3.7%), in BMI (-3.7%) and in WC (-3.5%), whereas FT promoted significant decrease in WC (-3.4%).","['women with obesity', 'Forty-four women (age=39.7±5.9 years, BMI=35.5±2.8 kg/m²']","['functional training and two interdisciplinary interventions', 'functional training (FT), interdisciplinary therapy (IT) and interdisciplinary education (IE', 'same training intervention plus nutrition', 'Interdisciplinary therapy', 'Functional training']","['cardiorespiratory fitness', 'anthropometric profile of women with obesity', 'VO2max and weight loss', 'CF (ergospirometry), anthropometry and body composition (electrical bioimpedance', 'WC', 'BMI', 'Body mass (BM), body mass index (BMI), relative fat mass (FM) and waist circumference (WC', 'Novelty bullets •', 'cardiorespiratory fitness (CF) and anthropometric characteristics', 'CF', 'BM']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C4319568', 'cui_str': '44'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}]","[{'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0003188', 'cui_str': 'Anthropometry'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0442828', 'cui_str': 'Electrical (qualifier value)'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C0336699', 'cui_str': 'Bullet, device (physical object)'}]",44.0,0.0398489,"IE showed a significant decrease in BM (-3.7%), in BMI (-3.7%) and in WC (-3.5%), whereas FT promoted significant decrease in WC (-3.4%).","[{'ForeName': 'Cauê Vazquez', 'Initials': 'CV', 'LastName': 'La Scala Teixeira', 'Affiliation': 'Obesity Study Group, Interdisciplinary Laboratory of Metabolic Diseases, Federal University of São Paulo, Santos, SP 11045-301, Brazil.'}, {'ForeName': 'Danielle Arisa', 'Initials': 'DA', 'LastName': 'Caranti', 'Affiliation': 'Obesity Study Group, Interdisciplinary Laboratory of Metabolic Diseases, Federal University of São Paulo, Santos, SP 11045-301, Brazil.'}, {'ForeName': 'Lila Missae', 'Initials': 'LM', 'LastName': 'Oyama', 'Affiliation': 'Department of Physiology, Paulista School of Medicine, Federal University of São Paulo, SP 04023-900, Brazil.'}, {'ForeName': 'Ricardo da Costa', 'Initials': 'RDC', 'LastName': 'Padovani', 'Affiliation': 'Post Graduate Program of Interdisciplinary Health Sciences, Federal University of São Paulo, Santos, SP 11015-020, Brazil.'}, {'ForeName': 'Maria Gabriela Soria', 'Initials': 'MGS', 'LastName': 'Cuesta', 'Affiliation': 'Obesity Study Group, Interdisciplinary Laboratory of Metabolic Diseases, Federal University of São Paulo, Santos, SP 11045-301, Brazil.'}, {'ForeName': 'Amanda Dos Santos', 'Initials': 'ADS', 'LastName': 'Moraes', 'Affiliation': 'Obesity Study Group, Interdisciplinary Laboratory of Metabolic Diseases, Federal University of São Paulo, Santos, SP 11045-301, Brazil.'}, {'ForeName': 'Letícia Andrade', 'Initials': 'LA', 'LastName': 'Cerrone', 'Affiliation': 'Obesity Study Group, Interdisciplinary Laboratory of Metabolic Diseases, Federal University of São Paulo, Santos, SP 11045-301, Brazil.'}, {'ForeName': 'Luiz Henrique Lima', 'Initials': 'LHL', 'LastName': 'Affonso', 'Affiliation': 'Obesity Study Group, Interdisciplinary Laboratory of Metabolic Diseases, Federal University of São Paulo, Santos, SP 11045-301, Brazil.'}, {'ForeName': 'Silvandro Dos Santos', 'Initials': 'SDS', 'LastName': 'Gil', 'Affiliation': 'Obesity Study Group, Interdisciplinary Laboratory of Metabolic Diseases, Federal University of São Paulo, Santos, SP 11045-301, Brazil.'}, {'ForeName': 'Ronaldo V Thomatieli', 'Initials': 'RVT', 'LastName': 'Dos Santos', 'Affiliation': 'Department of Bioscience, Federal University of São Paulo, Santos, SP 11015-020, Brazil.'}, {'ForeName': 'Ricardo José', 'Initials': 'RJ', 'LastName': 'Gomes', 'Affiliation': 'Obesity Study Group, Interdisciplinary Laboratory of Metabolic Diseases, Federal University of São Paulo, Santos, SP 11045-301, Brazil.'}]","Applied physiology, nutrition, and metabolism = Physiologie appliquee, nutrition et metabolisme",['10.1139/apnm-2019-0766'] 776,31970477,"Minodronate combined with alfacalcidol versus alfacalcidol alone for glucocorticoid-induced osteoporosis: a multicenter, randomized, comparative study.","INTRODUCTION This study compared the clinical usefulness of minodronate (50 mg/4 weeks) plus alfacalcidol (1 μg/day) (Group M) with that of alfacalcidol alone (1 μg/day) (Group A) for treating glucocorticoid-induced osteoporosis. MATERIALS AND METHODS The primary endpoints were the changes from baseline in lumbar spine (LS) bone mineral density (BMD) and the cumulative incidence of vertebral fracture at 24 months; secondary endpoints included the changes from baseline in total hip (TH) BMD and bone turnover markers. RESULTS Of 164 patients enrolled, 152 (Group M, n = 75; Group A, n = 77) were included in the analysis of efficacy. At each time point and at 24 months, LS BMD and TH BMD were significantly higher in Group M than in Group A. The 152 patients were divided into two subgroups that were previously treated with glucocorticoids for ≤ 3 months or > 3 months. In both subgroups, the changes from baseline in LS BMD and TH BMD from baseline at 24 months had increased more in Group M than in Group A. There were no differences found in the incidence of vertebral fracture between the groups, because the number of enrolled patients was lesser than that initially expected. In Group M, both bone formation and resorption markers significantly decreased from baseline at 3 months and maintained at 6, 12, and 24 months. CONCLUSIONS Minodronate plus alfacalcidol was more effective than alfacalcidol alone in increasing BMD and was effective in increasing BMD for both prevention and treatment. Therefore, minodronate can be a good candidate drug for the treatment of glucocorticoid-induced osteoporosis.",2020,"In Group M, both bone formation and resorption markers significantly decreased from baseline at 3 months and maintained at 6, 12, and 24 months. ","['glucocorticoid-induced osteoporosis', '152 patients were divided into two subgroups that were previously treated with', '164 patients enrolled, 152 (Group M, n\u2009']","['glucocorticoid-induced osteoporosis', 'glucocorticoids for\u2009≤\u20093\xa0months or\u2009', 'Minodronate combined with alfacalcidol versus alfacalcidol alone', 'minodronate (50\xa0mg/4\xa0weeks) plus alfacalcidol', 'alfacalcidol alone']","['BMD', 'changes from baseline in lumbar spine (LS) bone mineral density (BMD) and the cumulative incidence of vertebral fracture', 'total hip (TH) BMD and bone turnover markers', 'LS BMD and TH BMD', 'bone formation and resorption markers', 'incidence of vertebral fracture']","[{'cui': 'C3540778', 'cui_str': 'Glucocorticoids'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0441847', 'cui_str': 'Group M (qualifier value)'}]","[{'cui': 'C3540778', 'cui_str': 'Glucocorticoids'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0662880', 'cui_str': '(1-hydroxy-2-(imidazo(1,2-a)-pyridin-3-yl)ethylidene)bisphosphonic acid monohydrate'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0044410', 'cui_str': 'Alfacalcidol'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C3887615', 'cui_str': 'Lumbar spine structure (body structure)'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0080179', 'cui_str': 'Spinal Fractures'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0085268', 'cui_str': 'Bone Turnover'}, {'cui': 'C0029433', 'cui_str': 'Ossification'}]",164.0,0.0338374,"In Group M, both bone formation and resorption markers significantly decreased from baseline at 3 months and maintained at 6, 12, and 24 months. ","[{'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Soen', 'Affiliation': 'Department of Orthopaedic Surgery and Rheumatology, KINDAI University Nara Hospital, Nara, Japan. nra48207@nifty.com.'}, {'ForeName': 'Kazuhiko', 'Initials': 'K', 'LastName': 'Yamamoto', 'Affiliation': 'Department of Allergy and Rheumatology, Graduate School of Medicine and Faculty of Medicine, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Tsutomu', 'Initials': 'T', 'LastName': 'Takeuchi', 'Affiliation': 'Division of Rheumatology, Department of Internal Medicine, Keio University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Yoshiya', 'Initials': 'Y', 'LastName': 'Tanaka', 'Affiliation': 'The First Department of Internal Medicine, University of Occupational and Environmental Health, Kitakyushu, Japan.'}, {'ForeName': 'Sakae', 'Initials': 'S', 'LastName': 'Tanaka', 'Affiliation': 'Department of Orthopaedic Surgery, Graduate School of Medicine and Faculty of Medicine, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Masako', 'Initials': 'M', 'LastName': 'Ito', 'Affiliation': 'Nagasaki Study Center, The Open University of Japan, Nagasaki, Japan.'}, {'ForeName': 'Tetsuo', 'Initials': 'T', 'LastName': 'Nakano', 'Affiliation': 'Department of Orthopaedic Surgery, Tamana Central Hospital, Kumamoto, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Hagino', 'Affiliation': 'School of Health ScienceFaculty of Medicine, Tottori University, Tottori, Japan.'}, {'ForeName': 'Akihiro', 'Initials': 'A', 'LastName': 'Hirakawa', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Graduate School of Medicine and Faculty of Medicine, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Toshio', 'Initials': 'T', 'LastName': 'Matsumoto', 'Affiliation': 'Fujii Memorial Institute of Medical Sciences, Tokushima University, Tokushima, Japan.'}]",Journal of bone and mineral metabolism,['10.1007/s00774-019-01077-x'] 777,31970791,The effects of clinical education program based on Watson's theory of human caring on coping and anxiety levels of nursing students: A randomized control trial.,"PURPOSE The purpose of this study is to examine the effect of the clinical education program based on Watson's human caring theory on coping and anxiety levels of nursing students. DESIGN AND METHODS The research sample consisted of the intervention (n = 53) and the control (n = 53) group. FINDINGS A statistically significant difference was determined in anxiety mean scores (P < .001) and the self-confident approach, the social-support seeking approach, the unconfident approach, and the submissive approach subscales of coping with stress in students of the intervention group compared to the control group (P < .05). PRACTICE IMPLICATIONS It is recommended that the clinical education program based on Watson's caring theory is used during the clinical education of nursing students.",2020,"FINDINGS A statistically significant difference was determined in anxiety mean scores (P < .001) and the self-confident approach, the social-support seeking approach, the unconfident approach, and the submissive approach subscales of coping with stress in students of the intervention group compared to the control group (P < .05). ","['human caring on coping and anxiety levels of nursing students', 'nursing students']",['clinical education program'],"['anxiety mean scores', 'submissive approach subscales of coping with stress']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety (observable entity)'}, {'cui': 'C0038496', 'cui_str': 'Pupil Nurses'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0729314', 'cui_str': 'Education provision (procedure)'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}]",,0.0222636,"FINDINGS A statistically significant difference was determined in anxiety mean scores (P < .001) and the self-confident approach, the social-support seeking approach, the unconfident approach, and the submissive approach subscales of coping with stress in students of the intervention group compared to the control group (P < .05). ","[{'ForeName': 'Yeter', 'Initials': 'Y', 'LastName': 'Durgun Ozan', 'Affiliation': 'Department of Nursing, School of Health Dicle University, Diyarbakır, Turkey.'}, {'ForeName': 'Mesude', 'Initials': 'M', 'LastName': 'Duman', 'Affiliation': 'Department of Nursing, School of Health Dicle University, Diyarbakır, Turkey.'}, {'ForeName': 'Özlem', 'Initials': 'Ö', 'LastName': 'Çiçek', 'Affiliation': 'Department of Gynecology and Obstetric Nursing, Faculty of Nursing Dokuz Eylul University, Izmir, Turkey.'}, {'ForeName': 'Altun', 'Initials': 'A', 'LastName': 'Baksi', 'Affiliation': 'Department of Nursing, Faculty of Health Sciences, Suleyman Demirel University, Isparta, Turkey.'}]",Perspectives in psychiatric care,['10.1111/ppc.12477'] 778,30584179,Application of 640-slice CT wide-detector volume scan in low-dose CT pulmonary angiography.,"BACKGROUND Computed tomography (CT) pulmonary angiography (CTPA) examination has been frequently applied in detecting suspected pulmonary embolism (PE). How to reduce radiation dose to patients is also of concern. OBJECTIVE To assess the value of using 640-slice CT wide-detector volume scan with adaptive statistical iterative reconstruction (ASIR) algorithm in low-dose CTPA. METHODS Fifty-eight patients who performed with CTPA were divided into two groups randomly. In the first experimental group (n = 30), ASIR combined with volume scan were performed on the patients, while in the second conventional group (n = 28), patients received ASIR combined with conventional spiral scan. General data including age and body mass index, image quality, pulmonary arterial phase, and radiation dose were analyzed by t test in the two groups. RESULTS In both groups, all images revealed the 5-order or higher pulmonary arterial branches and fully met the needs for clinical diagnosis. There was no statistical difference in general data between the two groups. In terms of pulmonary phase accuracy, compared with the conventional group, images at pulmonary arterial phase could be captured more accurately in the experimental group. CTDI in the experimental group decreased by 30% compared with that in the conventional group. The actual radiation dose in the experimental group was 1.5 mSv, which is reduced by 53% compared to that in the conventional group. CONCLUSIONS Compared with the conventional spiral scan, using 640-slice CT volume scan with ASIR in CTPA is more accurate in scanning phase and has lower radiation dose. There is no significant difference in image quality between the two groups.",2019,"In terms of pulmonary phase accuracy, compared with the conventional group, images at pulmonary arterial phase could be captured more accurately in the experimental group.",['Fifty-eight patients who performed with CTPA'],"['640-slice CT wide-detector volume scan', 'Computed tomography (CT) pulmonary angiography (CTPA) examination', '640-slice CT wide-detector volume scan with adaptive statistical iterative reconstruction (ASIR) algorithm', 'ASIR combined with conventional spiral scan', 'ASIR combined with volume scan']","['age and body mass index, image quality, pulmonary arterial phase, and radiation dose', 'image quality', 'CTDI']","[{'cui': 'C4517817', 'cui_str': '58'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0651007', 'cui_str': '4-((1,4,8,11-tetraazacyclotetradec-1-yl)methyl)benzoic acid'}]","[{'cui': 'C4708790', 'cui_str': '640'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0441633'}, {'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}, {'cui': 'C0677490', 'cui_str': 'Pulmonary angiogram'}, {'cui': 'C1273867', 'cui_str': 'Examination (heading)'}, {'cui': 'C0524865', 'cui_str': 'Reconstructive Surgery'}, {'cui': 'C0002045'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0522554', 'cui_str': 'Spiral'}]","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C4522268', 'cui_str': 'Pulmonary'}, {'cui': 'C0221464', 'cui_str': 'Arterial (qualifier value)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}]",58.0,0.0185853,"In terms of pulmonary phase accuracy, compared with the conventional group, images at pulmonary arterial phase could be captured more accurately in the experimental group.","[{'ForeName': 'Fengqi', 'Initials': 'F', 'LastName': 'Lu', 'Affiliation': 'Department of Radiology, Nanjing Medical University Affiliated Wuxi the Second Hospital, Wuxi City, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Gao', 'Affiliation': 'Department of Radiology, Nanjing Medical University Affiliated Wuxi the Second Hospital, Wuxi City, China.'}, {'ForeName': 'Que', 'Initials': 'Q', 'LastName': 'Kong', 'Affiliation': 'Department of Radiology, Nanjing Medical University Affiliated Wuxi the Second Hospital, Wuxi City, China.'}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Qiao', 'Affiliation': 'Department of Radiology, Nanjing Medical University Affiliated Wuxi the Second Hospital, Wuxi City, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Shao', 'Affiliation': 'Department of Radiology, Nanjing Medical University Affiliated Wuxi the Second Hospital, Wuxi City, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Xie', 'Affiliation': 'Department of Radiology, Nanjing Medical University Affiliated Wuxi the Second Hospital, Wuxi City, China.'}]",Journal of X-ray science and technology,['10.3233/XST-180427'] 779,31976633,Sedentary Behaviour and Diabetes Information as a Source of Motivation to Reduce Daily Sitting Time in Office Workers: A Pilot Randomised Controlled Trial.,"BACKGROUND Using the motivational phase of the Health Action Process Approach (HAPA), this study examined whether sedentary behaviour and diabetes information is a meaningful source of motivation to reduce daily sitting time among preintending office workers. METHODS Participants (N = 218) were randomised into HAPA-intervention (sedentary behaviour), HAPA-attention control (physical activity), or control (no treatment) conditions. Following treatment, purpose-built sedentary-related HAPA motivational constructs (risk perception, outcome expectancies, self-efficacy) and goal intentions were assessed. Only participants who had given little thought to how much time they spent sitting (preintenders) were used in subsequent analyses (n = 96). RESULTS Significant main effects favouring the intervention group were reported for goal intentions: to increase number and length of daily breaks from sitting at work; to reduce daily sitting time outside of work; to increase daily time spent standing outside of work, as well as for outcome expectancies (p values ≤ .05; ɳ p 2 values ≥.08). Only self-efficacy (β range = 0.39-0.50) made significant and unique contributions to work and leisure-time-related goal intentions, explaining 11-21 per cent of the response variance. CONCLUSIONS A brief, HAPA-based online intervention providing information regarding sedentary behaviour and diabetes risk may be an effective source of motivation.",2020,"RESULTS Significant main effects favouring the intervention group were reported for goal intentions: to increase number and length of daily breaks from sitting at work; to reduce daily sitting time outside of work; to increase daily time spent standing outside of work, as well as for outcome expectancies (p values ≤ .05; ɳ p 2 values ≥.08).","['Office Workers', 'Participants (N\xa0=\xa0218']","['HAPA-intervention (sedentary behaviour), HAPA-attention control (physical activity), or control (no treatment) conditions', 'HAPA-based online intervention']","['HAPA motivational constructs (risk perception, outcome expectancies, self-efficacy) and goal intentions', 'number and length of daily breaks from sitting at work; to reduce daily sitting time outside of work; to increase daily time spent standing outside of work, as well as for outcome expectancies', 'goal intentions']","[{'cui': 'C0442603', 'cui_str': 'Office (environment)'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C4517647', 'cui_str': 'Two hundred and eighteen'}]","[{'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0018017', 'cui_str': 'Goals'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C2584297', 'cui_str': 'Seated Position'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205101', 'cui_str': 'External (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C3888057', 'cui_str': 'Stand'}]",218.0,0.0560881,"RESULTS Significant main effects favouring the intervention group were reported for goal intentions: to increase number and length of daily breaks from sitting at work; to reduce daily sitting time outside of work; to increase daily time spent standing outside of work, as well as for outcome expectancies (p values ≤ .05; ɳ p 2 values ≥.08).","[{'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Rollo', 'Affiliation': 'The University of Western Ontario, London, Ontario, Canada.'}, {'ForeName': 'Harry', 'Initials': 'H', 'LastName': 'Prapavessis', 'Affiliation': 'The University of Western Ontario, London, Ontario, Canada.'}]",Applied psychology. Health and well-being,['10.1111/aphw.12190'] 780,31969238,Clinical Efficacy of Combination Therapy with Podophyllotoxin and Liquid Nitrogen Cryotherapy in the Treatment of Genital Warts in Men.,"High prevalence, peculiar etiopathogenesis, and ineffective therapies have contributed to the fact that genital warts are one of the most challenging issues in modern medicine. This prospective study was aimed at determining the clinical efficacy of combination therapy with 0.5% podophyllotoxin solution and liquid nitrogen cryotherapy in the local treatment of genital warts in men. One hundred and ten consecutive male patients with genital warts were randomly assigned to two groups. The control group consisted of two subgroups: 30 patients treated with podophyllotoxin and 30 patients treated with cryotherapy. The experimental group included 50 patients treated with combination therapy. The therapy continued until complete regression, but not longer than six weeks. Analysis of the average increase in the number of cleared warts compared to week zero found a significant clinical improvement in the group treated with a combination therapy in relation to the group treated with podophyllotoxin at the end of each of the six weeks and in comparison with the group treated with cryotherapy at the end of each of the first three weeks. After discontinuation of therapy, a significantly lower recurrence rate and appearance of new condylomas was observed at the end of the third month in the group treated with a combination therapy compared with each group treated with monotherapy, and at the end of the sixth month compared with patients treated with cryotherapy. The combination of podophyllotoxin and cryotherapy showed a significantly higher efficacy in the treatment of genital warts in comparison with monotherapy with podophyllotoxin after 6 weeks of treatment (P<0.001), with considerably lower recurrence and appearance of new warts compared with cryotherapy during the 6 months after therapy (P<0.005).",2019,"The combination of podophyllotoxin and cryotherapy showed a significantly higher efficacy in the treatment of genital warts in comparison with monotherapy with podophyllotoxin after 6 weeks of treatment (P<0.001), with considerably lower recurrence and appearance of new warts compared with cryotherapy during the 6 months after therapy (P<0.005).","['50 patients treated with', 'One hundred and ten consecutive male patients with genital warts', 'Genital Warts in Men', 'genital warts in men', '30 patients treated with']","['podophyllotoxin', 'podophyllotoxin and cryotherapy', 'combination therapy with 0.5% podophyllotoxin solution and liquid nitrogen cryotherapy', 'cryotherapy', 'Podophyllotoxin and Liquid Nitrogen Cryotherapy', 'combination therapy']","['recurrence rate and appearance of new condylomas', 'number of cleared warts', 'efficacy']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C4517536', 'cui_str': '110 (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0009663', 'cui_str': 'Warts, Venereal'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C0032334', 'cui_str': 'podophyllotoxin'}, {'cui': 'C4551716', 'cui_str': 'Cryotherapy'}, {'cui': 'C0556895', 'cui_str': 'Combination therapy (regime/therapy)'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}, {'cui': 'C0260055', 'cui_str': 'Liquid nitrogen (substance)'}]","[{'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0700364', 'cui_str': 'Appearances (qualifier value)'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C2963144', 'cui_str': 'Clear (qualifier value)'}, {'cui': 'C3665596', 'cui_str': 'Verruca'}]",110.0,0.0144092,"The combination of podophyllotoxin and cryotherapy showed a significantly higher efficacy in the treatment of genital warts in comparison with monotherapy with podophyllotoxin after 6 weeks of treatment (P<0.001), with considerably lower recurrence and appearance of new warts compared with cryotherapy during the 6 months after therapy (P<0.005).","[{'ForeName': 'Zoran', 'Initials': 'Z', 'LastName': 'Golušin', 'Affiliation': 'Prof. Zoran Golušin, MD, PhD, University of Novi Sad, Faculty of Medicine, Hajduk Veljkova 3, 21000 Novi Sad, Serbia; zoran.golusin@mf.uns.ac.rs.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Jovanović', 'Affiliation': ''}, {'ForeName': 'Milan', 'Initials': 'M', 'LastName': 'Matić', 'Affiliation': ''}, {'ForeName': 'Tatjana', 'Initials': 'T', 'LastName': 'Roš', 'Affiliation': ''}, {'ForeName': 'Ljuba', 'Initials': 'L', 'LastName': 'Vujanović', 'Affiliation': ''}, {'ForeName': 'Olivera', 'Initials': 'O', 'LastName': 'Nikolić', 'Affiliation': ''}]",Acta dermatovenerologica Croatica : ADC,[] 781,31659983,The obesity paradox revisited: body mass index and -long-term outcomes after PCI from a large pooled patient-level database.,"AIMS The aim of this study was to evaluate the relationship between body mass index (BMI) and outcomes in patients with coronary artery disease undergoing percutaneous revascularisation. METHODS AND RESULTS In 13 randomised trials, 22,922 patients were stratified (in kg/m2) as underweight (BMI <18.5), normal weight (18.5 ≤BMI <25, used as reference), overweight (25 ≤BMI <30), and obese (Class I [30 ≤BMI <35], Class II [35 ≤BMI <40], or Class III [BMI ≥40]). The primary endpoint was all-cause death at five years. Secondary endpoints were cardiac and non-cardiac death, target (TLR) and non-target lesion revascularisation (NTLR), myocardial infarction (MI), and definite/probable stent thrombosis. Despite adjustment for multiple confounders, overweight and Class I obesity were associated with lower all-cause mortality versus normal weight (HR 0.83, 95% CI: 0.71-0.96, and HR 0.83, 95% CI: 0.69-0.96, respectively); however, non-cardiac death was the major contributor to this effect (HR 0.77, 95% CI: 0.63-0.94 for overweight). Conversely, cardiac mortality was higher in severely obese individuals (HR 1.62, 95% CI: 1.05-2.51 for Class III obesity). Obesity was associated with higher rates of NTLR (HR 1.28, 95% CI: 1.04-1.58 for Class II obesity) but not with TLR, MI and stent thrombosis. CONCLUSIONS Moderately increased BMI is associated with improved survival post PCI, mostly due to lower non-cardiac but not cardiac mortality.",2020,"Moderately increased BMI is associated with improved survival post-PCI, mostly due to lower non-cardiac but not cardiac mortality.","['patients with coronary artery disease undergoing percutaneous revascularization', '13 randomized trials 22,922 patients were stratified (in kg/m2) as underweight (BMI <18.5), normal weight (18.5≤BMI<25, used as reference), overweight (25≤BMI<30), and obese (Class I [30≤BMI<35], Class II [35≤BMI<40], or Class III [BMI≥40']",[],"['BMI', 'rates of NTLR', 'cardiac mortality', 'cause death', 'cardiac and non-cardiac death, target (TLR) and non-target lesion revascularization (NTLR), myocardial infarction (MI), and definite/probable stent thrombosis']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach - access (qualifier value)'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}, {'cui': 'C0205363', 'cui_str': 'Stratified (qualifier value)'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C0041667', 'cui_str': 'Underweight'}, {'cui': 'C2712185', 'cui_str': 'Normal weight (finding)'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0441885', 'cui_str': 'Class 1 (qualifier value)'}, {'cui': 'C0441886', 'cui_str': 'Class 2 (qualifier value)'}, {'cui': 'C0441887', 'cui_str': 'Class 3 (qualifier value)'}]",[],"[{'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0376297', 'cui_str': 'Cardiac Death'}, {'cui': 'C0014742', 'cui_str': 'Erythema Multiforme'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0439544', 'cui_str': 'Definite (qualifier value)'}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis (contextual qualifier) (qualifier value)'}, {'cui': 'C3897493', 'cui_str': 'Stent thrombosis'}]",,0.0990975,"Moderately increased BMI is associated with improved survival post-PCI, mostly due to lower non-cardiac but not cardiac mortality.","[{'ForeName': 'Rafal', 'Initials': 'R', 'LastName': 'Wolny', 'Affiliation': 'Institute of Cardiology, Warsaw, Poland.'}, {'ForeName': 'Akiko', 'Initials': 'A', 'LastName': 'Maehara', 'Affiliation': ''}, {'ForeName': 'Yangbo', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': ''}, {'ForeName': 'Zixuan', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': ''}, {'ForeName': 'Gary S', 'Initials': 'GS', 'LastName': 'Mintz', 'Affiliation': ''}, {'ForeName': 'Björn', 'Initials': 'B', 'LastName': 'Redfors', 'Affiliation': ''}, {'ForeName': 'Mahesh V', 'Initials': 'MV', 'LastName': 'Madhavan', 'Affiliation': ''}, {'ForeName': 'Pieter C', 'Initials': 'PC', 'LastName': 'Smits', 'Affiliation': ''}, {'ForeName': 'Clemens', 'Initials': 'C', 'LastName': 'von Birgelen', 'Affiliation': ''}, {'ForeName': 'Patrick W', 'Initials': 'PW', 'LastName': 'Serruys', 'Affiliation': ''}, {'ForeName': 'Roxana', 'Initials': 'R', 'LastName': 'Mehran', 'Affiliation': ''}, {'ForeName': 'Martin B', 'Initials': 'MB', 'LastName': 'Leon', 'Affiliation': ''}, {'ForeName': 'Gregg W', 'Initials': 'GW', 'LastName': 'Stone', 'Affiliation': ''}]",EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology,['10.4244/EIJ-D-19-00467'] 782,31965445,Therapeutic response in children with ADHD: role of observers and settings.,"BACKGROUND This study aims at characterizing the extent of correlation of treatment response (TR) obtained in various observation settings (home, school, clinic) by different observers (parents, teachers, clinicians). METHODS Children with attention deficit hyperactivity disorder (ADHD) underwent a 2-week double-blind, randomized, cross-over clinical trial with methylphenidate and placebo, and various measures were obtained during the 2 weeks. Interrelationships of TR were examined using Pearson's correlation coefficients. RESULTS The study included 526 children (420 male, 106 female) with ADHD. TR between different observers shows a variable correlation between parents and teachers. No correlation is seen between parents/teacher evaluation of TR and laboratory-based measures (Continuous Performance Task; Restricted Academic Situation Scale). CONCLUSION The results firmly support the need to synthesize information from many sources in evaluating TR in ADHD.",2020,"No correlation is seen between parents/teacher evaluation of TR and laboratory-based measures (Continuous Performance Task; Restricted Academic Situation Scale). ","['children with ADHD', '526 children (420 male, 106 female) with ADHD', 'Children with attention deficit hyperactivity disorder (ADHD']",['methylphenidate and placebo'],['Therapeutic response'],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C4517774', 'cui_str': 'Four hundred and twenty'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}]","[{'cui': 'C0025810', 'cui_str': 'Methylphenidate'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0521982', 'cui_str': 'Therapeutic response, function (observable entity)'}]",526.0,0.0933233,"No correlation is seen between parents/teacher evaluation of TR and laboratory-based measures (Continuous Performance Task; Restricted Academic Situation Scale). ","[{'ForeName': 'Venkat', 'Initials': 'V', 'LastName': 'Bhat', 'Affiliation': 'Douglas Mental Health University Institute, FBC Building, 6875 Boul. LaSalle, Verdun, QC, H4H 1R3, Canada.'}, {'ForeName': 'Sarojini M', 'Initials': 'SM', 'LastName': 'Sengupta', 'Affiliation': 'Douglas Mental Health University Institute, FBC Building, 6875 Boul. LaSalle, Verdun, QC, H4H 1R3, Canada.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Grizenko', 'Affiliation': 'Douglas Mental Health University Institute, FBC Building, 6875 Boul. LaSalle, Verdun, QC, H4H 1R3, Canada.'}, {'ForeName': 'Ridha', 'Initials': 'R', 'LastName': 'Joober', 'Affiliation': 'Douglas Mental Health University Institute, FBC Building, 6875 Boul. LaSalle, Verdun, QC, H4H 1R3, Canada. ridha.joober@mcgill.ca.'}]",World journal of pediatrics : WJP,['10.1007/s12519-019-00332-5'] 783,31964428,"Daily intake of non-fried potato does not affect markers of glycaemia and is associated with better diet quality compared with refined grains: a randomised, crossover study in healthy adults.","Epidemiological studies suggest that consumption of potatoes is associated with increased risk of cardiometabolic diseases. However, few clinical trials have empirically tested this. The aim of this single-blind, randomised, crossover study was to evaluate the effect of daily potato consumption, compared with refined grains, on risk factors for cardiometabolic diseases. It was hypothesised that no difference in cardiometabolic endpoints would be detected between conditions, but diet quality would improve with potato consumption. Healthy participants on self-selected diets received one potato-based side dish or one refined grain-based side dish daily, for 4 weeks, separated by a minimum 2-week break. Dishes were isoenergetic, carbohydrate-matched and prepared without excess saturated fat or Na. Participants were instructed to consume the side dish with a meal in place of carbohydrates habitually consumed. Lipids/lipoproteins, markers of glycaemic control, blood pressure, weight and pulse wave velocity were measured at baseline and condition endpoints. Diet quality was calculated, based on 24-h recalls, using the Healthy Eating Index (HEI)-2015. Fifty adults (female n 34; age 40 (sd 13) years; BMI 24·5 (sd 3·6) kg/m2) completed the present study. No between-condition differences were detected for fasting plasma glucose (-0·05 mmol/l, 95 % CI -0·14, 0·04; P = 0·15), the primary outcome or any other outcomes. Compared with refined grains, the HEI-2015 score (3·5, 95 % CI 0·6, 6·4; P = 0·01), K (547 mg, 95 % CI 331, 764, P < 0·001) and fibre (2·4 g, 95 % CI 0·6, 4·2, P = 0·01) were higher following the potato condition. Consuming non-fried potatoes resulted in higher diet quality, K and fibre intake, without adversely affecting cardiometabolic risk.",2020,"Compared with refined grains, the HEI-2015 score (3.5, 95%CI: 0.6, 6.4 p=0.01), potassium (547 mg, 95%CI: 331, 764, p<0.001) and fiber (2.4 g, 95% CI: 0.6, 4.2, p=0.01) were higher following the potato condition.","['Fifty adults (female n=34; age: 40±13; BMI: 24.5±3.6 kg/m2) completed this study', 'healthy adults', 'Healthy participants on self-selected diets received one']","['potato-based side dish or one refined grain-based side dish daily', 'daily potato consumption', 'isocaloric, carbohydrate-matched, and prepared without excess saturated fat or sodium']","['Diet quality', 'Lipids/lipoproteins, markers of glycemic control, blood pressure (BP), weight and pulse wave velocity (PWV', 'Healthy Eating Index', 'cardiometabolic risk', 'diet quality, potassium and fiber intake', 'cardiometabolic endpoints', 'diet quality', 'HEI-2015 score', 'fasting plasma glucose']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0012155', 'cui_str': 'Diet'}]","[{'cui': 'C0032846', 'cui_str': 'Potato'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0020498', 'cui_str': 'Vertebral Ankylosing Hyperostosis'}, {'cui': 'C0086369', 'cui_str': 'Grain (substance)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C4082130', 'cui_str': 'Prepared (qualifier value)'}, {'cui': 'C0597423', 'cui_str': 'Fatty Acids, Saturated'}, {'cui': 'C3541959', 'cui_str': 'Sodium supplement (substance)'}]","[{'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0023820', 'cui_str': 'Circulating Lipoproteins'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C3494431', 'cui_str': 'Pulse Wave Velocity'}, {'cui': 'C4280021', 'cui_str': 'Healthy Eating Index'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0304475', 'cui_str': 'Potassium supplement'}, {'cui': 'C0225326', 'cui_str': 'Fiber'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma (procedure)'}]",50.0,0.184734,"Compared with refined grains, the HEI-2015 score (3.5, 95%CI: 0.6, 6.4 p=0.01), potassium (547 mg, 95%CI: 331, 764, p<0.001) and fiber (2.4 g, 95% CI: 0.6, 4.2, p=0.01) were higher following the potato condition.","[{'ForeName': 'E A', 'Initials': 'EA', 'LastName': 'Johnston', 'Affiliation': 'Department of Nutritional Sciences, The Pennsylvania State University, University Park, PA16802, USA.'}, {'ForeName': 'K S', 'Initials': 'KS', 'LastName': 'Petersen', 'Affiliation': 'Department of Nutritional Sciences, The Pennsylvania State University, University Park, PA16802, USA.'}, {'ForeName': 'P M', 'Initials': 'PM', 'LastName': 'Kris-Etherton', 'Affiliation': 'Department of Nutritional Sciences, The Pennsylvania State University, University Park, PA16802, USA.'}]",The British journal of nutrition,['10.1017/S0007114520000252'] 784,30553916,Increased cerebral blood flow after single dose of antipsychotics in healthy volunteers depends on dopamine D2 receptor density profiles.,"As a result of neuro-vascular coupling, the functional effects of antipsychotics in human brain have been investigated in both healthy and clinical populations using haemodynamic markers such as regional Cerebral Blood Flow (rCBF). However, the relationship between observed haemodynamic effects and the pharmacological action of these drugs has not been fully established. Here, we analysed Arterial Spin Labelling (ASL) rCBF data from a placebo-controlled study in healthy volunteers, who received a single dose of three different D2 receptor (D 2 R) antagonists and tested the association of the main effects of the drugs on rCBF against normative population maps of D 2 R protein density and gene-expression data. In particular, we correlated CBF changes after antipsychotic administration with non-displaceable binding potential (BP ND ) template maps of the high affinity D 2 -antagonist Positron Emission Tomography (PET) ligand [ 18 F]Fallypride and with brain post-mortem microarray mRNA expression data for the DRD2 gene from the Allen Human Brain Atlas (ABA). For all antipsychotics, rCBF changes were directly proportional to brain D 2 R densities and DRD2 mRNA expression measures, although PET BP ND spatial profiles explained more variance as compared with mRNA profiles (PET R 2 range = 0.20-0.60, mRNA PET R 2 range 0.04-0.20, pairwise-comparisons all p corrected <0.05). In addition, the spatial coupling between ΔCBF and D 2 R profiles varied between the different antipsychotics tested, possibly reflecting differential affinities. Overall, these results indicate that the functional effects of antipsychotics as measured with rCBF are tightly correlated with the distribution of their target receptors in striatal and extra-striatal regions. Our results further demonstrate the link between neurotransmitter targets and haemodynamic changes reinforcing rCBF as a robust in-vivo marker of drug effects. This work is important in bridging the gap between pharmacokinetic and pharmacodynamics of novel and existing compounds.",2019,"For all antipsychotics, rCBF changes were directly proportional to brain D 2 R densities and DRD2 mRNA expression measures, although PET BP ND spatial profiles explained more variance as compared with mRNA profiles (PET R 2 range = 0.20-0.60, mRNA PET R 2 range 0.04-0.20, pairwise-comparisons all p corrected <0.05).",['healthy volunteers'],['Positron Emission Tomography (PET) ligand '],"['CBF changes', 'cerebral blood flow', 'Arterial Spin Labelling (ASL) rCBF data']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0032743', 'cui_str': 'Positron-Emission Tomography'}, {'cui': 'C0023688', 'cui_str': 'Ligands'}]","[{'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0428714', 'cui_str': 'Cerebral Blood Flow'}, {'cui': 'C0221464', 'cui_str': 'Arterial (qualifier value)'}]",,0.0420817,"For all antipsychotics, rCBF changes were directly proportional to brain D 2 R densities and DRD2 mRNA expression measures, although PET BP ND spatial profiles explained more variance as compared with mRNA profiles (PET R 2 range = 0.20-0.60, mRNA PET R 2 range 0.04-0.20, pairwise-comparisons all p corrected <0.05).","[{'ForeName': 'Pierluigi', 'Initials': 'P', 'LastName': 'Selvaggi', 'Affiliation': ""Department of Neuroimaging, Institute of Psychiatry, Psychology and Neuroscience, King's College London, SE5 8AF, London, United Kingdom. Electronic address: pierluigi.selvaggi@kcl.ac.uk.""}, {'ForeName': 'Peter C T', 'Initials': 'PCT', 'LastName': 'Hawkins', 'Affiliation': ""Department of Neuroimaging, Institute of Psychiatry, Psychology and Neuroscience, King's College London, SE5 8AF, London, United Kingdom.""}, {'ForeName': 'Ottavia', 'Initials': 'O', 'LastName': 'Dipasquale', 'Affiliation': ""Department of Neuroimaging, Institute of Psychiatry, Psychology and Neuroscience, King's College London, SE5 8AF, London, United Kingdom.""}, {'ForeName': 'Gaia', 'Initials': 'G', 'LastName': 'Rizzo', 'Affiliation': 'Invicro, W12 0NN, London, UK; Division of Brain Sciences, Department of Medicine, Imperial College London, SW72AZ, London, UK.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Bertolino', 'Affiliation': 'Department of Basic Medical Science, Neuroscience and Sense Organs, University of Bari Aldo Moro, IT-70124, Bari, BA, Italy.'}, {'ForeName': 'Juergen', 'Initials': 'J', 'LastName': 'Dukart', 'Affiliation': 'F. Hoffmann-La Roche, Pharma Research Early Development, Roche Innovation Centre Basel, CH-4070, Basel, Switzerland.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Sambataro', 'Affiliation': 'Department of Experimental and Clinical Medical Sciences, University of Udine, IT-33100, Udine, Italy.'}, {'ForeName': 'Giulio', 'Initials': 'G', 'LastName': 'Pergola', 'Affiliation': 'Department of Basic Medical Science, Neuroscience and Sense Organs, University of Bari Aldo Moro, IT-70124, Bari, BA, Italy.'}, {'ForeName': 'Steven C R', 'Initials': 'SCR', 'LastName': 'Williams', 'Affiliation': ""Department of Neuroimaging, Institute of Psychiatry, Psychology and Neuroscience, King's College London, SE5 8AF, London, United Kingdom.""}, {'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Turkheimer', 'Affiliation': ""Department of Neuroimaging, Institute of Psychiatry, Psychology and Neuroscience, King's College London, SE5 8AF, London, United Kingdom.""}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Zelaya', 'Affiliation': ""Department of Neuroimaging, Institute of Psychiatry, Psychology and Neuroscience, King's College London, SE5 8AF, London, United Kingdom.""}, {'ForeName': 'Mattia', 'Initials': 'M', 'LastName': 'Veronese', 'Affiliation': ""Department of Neuroimaging, Institute of Psychiatry, Psychology and Neuroscience, King's College London, SE5 8AF, London, United Kingdom.""}, {'ForeName': 'Mitul A', 'Initials': 'MA', 'LastName': 'Mehta', 'Affiliation': ""Department of Neuroimaging, Institute of Psychiatry, Psychology and Neuroscience, King's College London, SE5 8AF, London, United Kingdom.""}]",NeuroImage,['10.1016/j.neuroimage.2018.12.028'] 785,30817010,Incorporating Writing into a Personalized Normative Feedback Intervention to Reduce Problem Drinking Among College Students.,"BACKGROUND Personalized normative feedback (PNF) interventions have repeatedly been found to reduce drinking among undergraduates. However, effects tend to be small, potentially due to inattention to and inadequate processing of the information. Adding a writing component to PNF interventions may allow for greater cognitive processing of the feedback, thereby boosting intervention efficacy. Additionally, expressive writing (EW) has been shown to reduce drinking intentions; however, studies have not examined whether it can reduce drinking behavior. The present experiment evaluated whether including a writing task would improve the efficacy of PNF and whether EW alone can be used to reduce drinking and alcohol-related problems. METHODS Heavy drinking undergraduates (N = 250) were randomized to receive either: (i) PNF about their alcohol use; (ii) EW about a negative, heavy drinking occasion; (iii) PNFplus writing about the norms feedback; or (iv) attention control feedback about their technology use in an online brief intervention. Participants (N = 169) then completed a 1-month follow-up survey about their past month alcohol use and alcohol-related problems online. RESULTS PNFplus writing reduced alcohol-related problems compared to all other conditions. No significant reductions were found for EW. Both PNF and PNFplus writing reduced perceived norms and perceived norms mediated intervention effects for both feedback conditions. CONCLUSIONS The current findings suggest that adding a writing component to traditional norms-based feedback approaches might be an efficacious strategy, particularly for reducing alcohol-related consequences.",2019,No significant reductions were found for EW.,"['College Students', 'Heavy drinking undergraduates (N\xa0=\xa0250', 'Participants (N\xa0=\xa0169) then completed a 1-month follow-up survey about their past month alcohol use and alcohol-related problems online']","['expressive writing (EW', 'Personalized Normative Feedback Intervention', 'Personalized normative feedback (PNF) interventions', 'PNF about their alcohol use; (ii) EW about a negative, heavy drinking occasion; (iii) PNFplus writing about the norms feedback; or (iv) attention control feedback', 'writing component to PNF interventions']",['alcohol-related problems'],"[{'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0439539', 'cui_str': 'Heavy sensation quality'}, {'cui': 'C0684271', 'cui_str': 'Drinkings'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}]","[{'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C0439539', 'cui_str': 'Heavy sensation quality'}, {'cui': 'C0684271', 'cui_str': 'Drinkings'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}]","[{'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}]",250.0,0.02444,No significant reductions were found for EW.,"[{'ForeName': 'Chelsie M', 'Initials': 'CM', 'LastName': 'Young', 'Affiliation': 'Department of Psychology, Rowan University, Glassboro, New Jersey.'}, {'ForeName': 'Clayton', 'Initials': 'C', 'LastName': 'Neighbors', 'Affiliation': 'Department of Psychology, University of Houston, Houston, Texas.'}]","Alcoholism, clinical and experimental research",['10.1111/acer.13995'] 786,30327875,Sequential H. pylori eradication and radiation therapy with reduced dose compared to standard dose for gastric MALT lymphoma stages IE & II1E: a prospective randomized trial.,"BACKGROUND In Helicobacter pylori (H. pylori) positive stage I gastric low-grade MALT lymphoma, eradication is the accepted first-line therapy. The role of eradication therapy in lymphoma > stage IE is still unclear. However, about 20% of patients show persistent lymphoma following successful eradication or primary H. pylori-negative lymphoma. A prospective study for salvage radiation therapy with standard 36 Gy in comparison to a reduced dose of 25.2 Gy is still missing. METHODS A prospective, multicentre study investigated the efficacy of eradication in H. pylori-positive gastric low-grade MALT lymphoma stages IE and II1E (HELYX I). Refractory lymphoma or H. pylori-negative patients were treated in a prospective, randomised, multicentre, phase II study to receive either 25.2 Gy or 36 Gy radiotherapy (HELYX II). RESULTS 102 patients (3 drop outs) were included in HELYX I: 75/99 (75.8%) showed complete remission after a median of 2.8 months. 18 (18.2%) had partial remission (PR) and 6 (6.0%) no change (NC). 29 patients (7 drop outs) were randomized in HELYX II (7 primarily H. pylori-negative, 15 patients from HELYX I with refractory disease after eradication). All patients achieved stable CR irrespective of radiation dose. Both presence of the t(11,18) translocation (OR 9.0, p = 0.01) and monoclonality of the tumour cells (OR 6.3, p = 0.006) were predictors for persistant lymphoma after eradication therapy. CONCLUSIONS Most H. pylori-positive low grade gastric MALT lymphoma stage IE and II1E respond with stable CR after eradication therapy. In patients with refractory disease or H. pylori negative low grade gastric MALT lymphoma a dosage-reduced radiation therapy with 25.2 Gy is an effective standard dose in stage IE and II1E. TRIAL REGISTRATION ClinicalTrials.gov: NCT00154440.",2019,"Both presence of the t(11,18) translocation (OR 9.0, p = 0.01) and monoclonality of the tumour cells (OR 6.3, p = 0.006) were predictors for persistant lymphoma after eradication therapy. ","['gastric MALT lymphoma stages IE & II1E', 'patients with refractory disease or H. pylori negative low grade gastric MALT lymphoma', '29 patients (7 drop outs', 'H. pylori-positive gastric low-grade MALT lymphoma stages IE and II1E', 'Refractory lymphoma or H. pylori-negative patients']","['HELYX', '25.2\xa0Gy or 36\xa0Gy radiotherapy (HELYX II', 'salvage radiation therapy']","['monoclonality of the tumour cells', 'complete remission', 'partial remission (PR']","[{'cui': 'C1704242', 'cui_str': 'Gastric (qualifier value)'}, {'cui': 'C0242647', 'cui_str': 'Mucosa-Associated Lymphoid Tissue Lymphoma'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0079488', 'cui_str': 'Helicobacter pylori'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C1962916', 'cui_str': 'Low grade (lymphoma)'}, {'cui': 'C4318619', 'cui_str': 'Drop (unit of presentation)'}, {'cui': 'C0439787', 'cui_str': 'Out (qualifier value)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0024299', 'cui_str': 'Germinoblastoma'}]","[{'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0442967', 'cui_str': 'Salvage procedure (qualifier value)'}, {'cui': 'C0034619', 'cui_str': 'radiation therapy'}]","[{'cui': 'C0431085', 'cui_str': 'Tumor cells, uncertain whether benign or malignant (morphologic abnormality)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}]",102.0,0.0501789,"Both presence of the t(11,18) translocation (OR 9.0, p = 0.01) and monoclonality of the tumour cells (OR 6.3, p = 0.006) were predictors for persistant lymphoma after eradication therapy. ","[{'ForeName': 'Renate', 'Initials': 'R', 'LastName': 'Schmelz', 'Affiliation': 'Medical Departement 1, University Hospital Carl Gustav Carus, Technical University, Fetscherstr. 74, 01307, Dresden, Germany. renate.schmelz@uniklinikum-dresden.de.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Miehlke', 'Affiliation': 'Center for Digestive Diseases, Cooperation of Internal Medicine, Hamburg, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Thiede', 'Affiliation': 'Medical Departement 1, University Hospital Carl Gustav Carus, Technical University, Fetscherstr. 74, 01307, Dresden, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Brueckner', 'Affiliation': 'Medical Departement 1, University Hospital Carl Gustav Carus, Technical University, Fetscherstr. 74, 01307, Dresden, Germany.'}, {'ForeName': 'Monic', 'Initials': 'M', 'LastName': 'Dawel', 'Affiliation': 'Department of Radiation Oncology, Faculty of Medicine, University Hospital Carl Gustav Carus, Technische Universität, Dresden, Germany.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Kuhn', 'Affiliation': 'Institute for Medical Informatics and Biometry, Technical University, Dresden, Germany.'}, {'ForeName': 'Agnes', 'Initials': 'A', 'LastName': 'Ruskoné-Formestraux', 'Affiliation': 'Service de Gastroentérologie, St Antoine Hospital, Paris, France.'}, {'ForeName': 'Manfred', 'Initials': 'M', 'LastName': 'Stolte', 'Affiliation': 'Institute for Pathology, Hospital Kulmbach, Kulmbach, Germany.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Jentsch', 'Affiliation': 'Department of Radiation Oncology, Faculty of Medicine, University Hospital Carl Gustav Carus, Technische Universität, Dresden, Germany.'}, {'ForeName': 'Jochen', 'Initials': 'J', 'LastName': 'Hampe', 'Affiliation': 'Medical Departement 1, University Hospital Carl Gustav Carus, Technical University, Fetscherstr. 74, 01307, Dresden, Germany.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Morgner', 'Affiliation': 'University Hospital Hamburg-Eppendorf, Center for Oncology and University Cancer Center Hamburg (UCCH), Hamburg, Germany.'}]",Journal of gastroenterology,['10.1007/s00535-018-1517-4'] 787,31984531,The effect of anger management skills training on anger status of the people with HIV.,"PURPOSE This study investigated the effect of anger management skills training on the anger status of people with HIV. DESIGN AND METHODS This interventional study was conducted on 60 people with HIV. The intervention group was trained on anger management skills. Data were collected using Spielberger's State-Trait Anger Expression Inventory-II. FINDINGS The intervention group's training on anger management skills showed a significant reduction in mean scores of the state-trait anger, and anger expression as well as a significant increase in mean scores of anger control-out and anger control-in. PRACTICE IMPLICATIONS Expert counselors, psychologists, community health, and psychiatric nurses are recommended to train anger management skills to people with HIV.",2020,"FINDINGS The intervention group's training on anger management skills showed a significant reduction in mean scores of the state-trait anger, and anger expression as well as a significant increase in mean scores of anger control-out and anger control-in. ","['people with HIV', 'anger status of the people with HIV', '60 people with HIV']",['anger management skills training'],"['mean scores of the state-trait anger, and anger expression', 'mean scores of anger control-out and anger control-in']","[{'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0002957', 'cui_str': 'Anger'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}]","[{'cui': 'C0557992', 'cui_str': 'Anger Management Training'}, {'cui': 'C0559197', 'cui_str': 'Skills training (procedure)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0002957', 'cui_str': 'Anger'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]",60.0,0.0276332,"FINDINGS The intervention group's training on anger management skills showed a significant reduction in mean scores of the state-trait anger, and anger expression as well as a significant increase in mean scores of anger control-out and anger control-in. ","[{'ForeName': 'Mehri', 'Initials': 'M', 'LastName': 'Lotfalizadeh', 'Affiliation': 'Social Determinants of Health Research Center, Institute for Futures Studies in Health, Kerman, Iran.'}, {'ForeName': 'Sakineh', 'Initials': 'S', 'LastName': 'Miri', 'Affiliation': 'Nursing Research Center, Kerman University of Medical Sciences, Kerman, Iran.'}, {'ForeName': 'Golnaz', 'Initials': 'G', 'LastName': 'Foroughameri', 'Affiliation': 'Department of Community Health Nursing, School of Nursing and Midwifery, Kerman University of Medical Sciences, Kerman, Iran.'}, {'ForeName': 'Jamileh', 'Initials': 'J', 'LastName': 'Farokhzadian', 'Affiliation': 'Nursing Research Center, Kerman University of Medical Sciences, Kerman, Iran.'}]",Perspectives in psychiatric care,['10.1111/ppc.12475'] 788,31961490,"The Incredible Years Autism Spectrum and Language Delays Parent Program: A Pragmatic, Feasibility Randomized Controlled Trial.","Behavior problems in children with autism spectrum disorders (ASD) are common and particularly stressful for parents. This study aimed to examine the feasibility of delivering a parenting program in existing services, and the feasibility of conducting a future large-scale Randomized Controlled Trial evaluation of the effectiveness of the intervention. Parents of children aged 3-8 years with a diagnosis of ASD, or strongly suspected ASD were eligible to participate. A multicenter, pragmatic, feasibility randomized controlled trial was conducted in four specialist children's services in Wales. Families were randomly assigned to receive the Incredible Years® Autism Spectrum and Language Delays (IY-ASLD) parent program immediately or to a wait-list, treatment as usual control condition. IY-ASLD sessions were delivered once a week for 12 weeks. The primary outcomes related to feasibility (recruitment, retention, fidelity, and acceptability). Preliminary outcome analyses were conducted using covariance models controlling for study site and baseline scores. From October 5 to December 19, 2016, 58 families were randomized, 29 to IY-ASLD and 29 to control. Three parents did not attend any sessions while 19 (73%) completed the program. Fidelity of delivery was high (88%), as was satisfaction with the program. Fifty-three (91%) completed the follow-up measures. All 95% CIs for effect sizes included zero in exploratory outcome analyses. This study supports the feasibility of delivering the IY-ASLD in existing services with good levels of acceptability and fidelity evident. A larger randomized controlled trial is required to examine the effectiveness of the program. Autism Res 2020, 13: 1011-1022. © 2020 International Society for Autism Research, Wiley Periodicals, Inc. LAY SUMMARY: This study examined the feasibility and acceptability of delivering a parenting program for parents of children aged 3-8 years with Autism Spectrum Disorder in existing child services. Recruitment and retention in the study were good and parents rated all aspects of the program positively. Practitioners were able to deliver the program as intended and the measures used for program outcomes were appropriate. A larger study to examine program effectiveness would be feasible.",2020,This study examined the feasibility and acceptability of delivering a parenting program for parents of children aged 3-8 years with Autism Spectrum Disorder in existing child services.,"['parents of children aged 3-8\u2009years with Autism Spectrum Disorder in existing child services', 'Incredible Years Autism Spectrum and Language Delays Parent Program', 'Parents of children aged 3-8\u2009years with a diagnosis of ASD, or strongly suspected ASD were eligible to participate', 'From October 5 to December 19, 2016, 58 families', ""four specialist children's services in Wales"", 'children with autism spectrum disorders (ASD']","['Incredible Years® Autism Spectrum and Language Delays (IY-ASLD) parent program immediately or to a wait-list, treatment as usual control condition', 'parenting program']","['feasibility (recruitment, retention, fidelity, and acceptability', 'Fidelity of delivery', 'Behavior problems']","[{'cui': 'C0030551', 'cui_str': 'Parent of (observable entity)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1510586', 'cui_str': 'Autism Spectrum Disorders'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0004352', 'cui_str': 'Autism, Early Infantile'}, {'cui': 'C0023012', 'cui_str': 'Language Delay'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0750491', 'cui_str': 'Suspected (qualifier value)'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0087009', 'cui_str': 'Specialists'}]","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0004352', 'cui_str': 'Autism, Early Infantile'}, {'cui': 'C0023012', 'cui_str': 'Language Delay'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}]",4.0,0.108766,This study examined the feasibility and acceptability of delivering a parenting program for parents of children aged 3-8 years with Autism Spectrum Disorder in existing child services.,"[{'ForeName': 'Margiad E', 'Initials': 'ME', 'LastName': 'Williams', 'Affiliation': 'Centre for Evidence Based Early Intervention, School of Psychology, Bangor University, Bangor, UK.'}, {'ForeName': 'Richard P', 'Initials': 'RP', 'LastName': 'Hastings', 'Affiliation': 'CEDAR, Faculty of Social Sciences, University of Warwick, Coventry, UK.'}, {'ForeName': 'Judy', 'Initials': 'J', 'LastName': 'Hutchings', 'Affiliation': 'Centre for Evidence Based Early Intervention, School of Psychology, Bangor University, Bangor, UK.'}]",Autism research : official journal of the International Society for Autism Research,['10.1002/aur.2265'] 789,31981556,Guided self-help to reduce psychological distress in South Sudanese female refugees in Uganda: a cluster randomised trial.,"BACKGROUND Innovative solutions are required to provide mental health support at scale in low-resource humanitarian contexts. We aimed to assess the effectiveness of a facilitator-guided, group-based, self-help intervention (Self-Help Plus) to reduce psychological distress in female refugees. METHODS We did a cluster randomised trial in rural refugee settlements in northern Uganda. Participants were female South Sudanese refugees with at least moderate levels of psychological distress (cutoff ≥5 on the Kessler 6). The intervention comprised access to usual care and five 2-h audio-recorded stress-management workshops (20-30 refugees) led by briefly trained lay facilitators, accompanied by an illustrated self-help book. Villages were randomly assigned to either intervention (Self-Help Plus or enhanced usual care) on a 1:1 basis. Within 14 villages, randomly selected households were approached. Screening of women in households continued until 20-30 eligible participants were identified per site. The primary outcome was individual psychological distress, assessed using the Kessler 6 symptom checklist 1 week before, 1 week after, and 3 months after intervention, in the intention-to-treat population. All outcomes were measured at the individual (rather than cluster) level. Secondary outcomes included personally identified problems, post-traumatic stress, depression symptoms, feelings of anger, social interactions with other ethnic groups, functional impairment, and subjective wellbeing. Assessors were masked to allocation. This trial was prospectively registered at ISRCTN, number 50148022. FINDINGS Of 694 eligible participants (331 Self-Help Plus, 363 enhanced usual care), 613 (88%) completed all assessments. Compared with controls, we found stronger improvements for Self-Help Plus on psychological distress 3 months post intervention (β -1·20, 95% CI -2·33 to -0·08; p=0·04; d -0·26). We also found larger improvements for Self-Help Plus 3 months post-intervention for five of eight secondary outcomes (effect size range -0·30 to -0·36). Refugees with different trauma exposure, length of time in settlements, and initial psychological distress benefited similarly. With regard to safety considerations, the independent data safety management board responded to six adverse events, and none were evaluated to be concerns in response to the intervention. INTERPRETATION Self-Help Plus is an innovative, facilitator-guided, group-based self-help intervention that can be rapidly deployed to large numbers of participants, and resulted in meaningful reductions in psychological distress at 3 months among South Sudanese female refugees. FUNDING Research for Health in Humanitarian Crises (R2HC) Programme.",2020,We also found larger improvements for Self-Help Plus 3 months post-intervention for five of eight secondary outcomes (effect size range -0·30 to -0·36).,"['female refugees', 'South Sudanese female refugees in Uganda', 'Participants were female South Sudanese refugees with at least moderate levels of psychological distress (cutoff ≥5 on the Kessler 6', 'women in households continued until 20-30 eligible participants', 'rural refugee settlements in northern Uganda', '694 eligible participants (331 Self-Help Plus']","['facilitator-guided, group-based, self-help intervention (Self-Help Plus', 'Self-Help', 'usual care and five 2-h audio-recorded stress-management workshops (20-30 refugees) led by briefly trained lay facilitators, accompanied by an illustrated self-help book', 'intervention (Self-Help Plus or enhanced usual care']","['personally identified problems, post-traumatic stress, depression symptoms, feelings of anger, social interactions with other ethnic groups, functional impairment, and subjective wellbeing', 'psychological distress', 'individual psychological distress, assessed using the Kessler 6 symptom checklist', 'length of time in settlements, and initial psychological distress']","[{'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0034961', 'cui_str': 'Refugees'}, {'cui': 'C0241297', 'cui_str': 'Sudanese (ethnic group)'}, {'cui': 'C0041573', 'cui_str': 'Republic of Uganda'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0011744', 'cui_str': 'Hydrogen-2'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0150788', 'cui_str': 'Manage stress control'}, {'cui': 'C0242262', 'cui_str': 'Workshops'}, {'cui': 'C0034961', 'cui_str': 'Refugees'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0600261', 'cui_str': 'Lying'}, {'cui': 'C0006002', 'cui_str': 'Books'}]","[{'cui': 'C0683510', 'cui_str': 'Identifying problems (procedure)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0332663', 'cui_str': 'Traumatic (qualifier value)'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0002957', 'cui_str': 'Anger'}, {'cui': 'C0037420', 'cui_str': 'Social Interaction'}, {'cui': 'C0015031', 'cui_str': 'Ethnicity'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0451524', 'cui_str': 'Symptom checklist (assessment scale)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}]",694.0,0.0951295,We also found larger improvements for Self-Help Plus 3 months post-intervention for five of eight secondary outcomes (effect size range -0·30 to -0·36).,"[{'ForeName': 'Wietse A', 'Initials': 'WA', 'LastName': 'Tol', 'Affiliation': 'Department of Mental Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA; Peter C Alderman Program for Global Mental Health, HealthRight International, New York, NY, USA. Electronic address: wtol@jhu.edu.'}, {'ForeName': 'Marx R', 'Initials': 'MR', 'LastName': 'Leku', 'Affiliation': 'Arua, Uganda.'}, {'ForeName': 'Daniel P', 'Initials': 'DP', 'LastName': 'Lakin', 'Affiliation': 'Department of Mental Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Carswell', 'Affiliation': 'Department of Mental Health and Substance Abuse, WHO, Geneva, Switzerland.'}, {'ForeName': 'Jura', 'Initials': 'J', 'LastName': 'Augustinavicius', 'Affiliation': 'Department of Mental Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Adaku', 'Affiliation': 'Arua, Uganda; Department of Psychiatry, Arua Regional Referral Hospital, Arua, Uganda.'}, {'ForeName': 'Teresa M', 'Initials': 'TM', 'LastName': 'Au', 'Affiliation': 'Department of Mental Health and Substance Abuse, WHO, Geneva, Switzerland.'}, {'ForeName': 'Felicity L', 'Initials': 'FL', 'LastName': 'Brown', 'Affiliation': 'WarChild Holland, Amsterdam, Netherlands.'}, {'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Bryant', 'Affiliation': 'School of Psychology, University of New South Wales, Sydney, NSW, Australia.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Garcia-Moreno', 'Affiliation': 'Department of Reproductive Health & Research, WHO, Geneva, Switzerland.'}, {'ForeName': 'Rashelle J', 'Initials': 'RJ', 'LastName': 'Musci', 'Affiliation': 'Department of Mental Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Ventevogel', 'Affiliation': 'Public Health Section, UN High Commissioner for Refugees, Geneva, Switzerland.'}, {'ForeName': 'Ross G', 'Initials': 'RG', 'LastName': 'White', 'Affiliation': 'Institute of Population Health, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'van Ommeren', 'Affiliation': 'Department of Mental Health and Substance Abuse, WHO, Geneva, Switzerland.'}]",The Lancet. Global health,['10.1016/S2214-109X(19)30504-2'] 790,31981558,Cause-specific mortality of children younger than 5 years in communities receiving biannual mass azithromycin treatment in Niger: verbal autopsy results from a cluster-randomised controlled trial.,"BACKGROUND The Macrolides Oraux pour Réduire les Décès avec un Oeil sur la Résistance (MORDOR) trial found that biannual mass distribution of azithromycin to children younger than 5 years in Niger reduced the primary outcome of all-cause mortality by 18%. We aimed to determine the causes of mortality among deceased children using verbal autopsy. METHODS In this 2-year cluster-randomised controlled trial, 594 community clusters in Niger were randomly allocated (1:1 ratio) to receive biannual mass distributions of either oral azithromycin (approximately 20 mg per kg of bodyweight) or placebo targeted to children aged 1-59 months. Participants, study investigators, and field workers were masked to treatment allocation. Between Nov 23, 2014, and July 31, 2017, 3615 child deaths were recorded by use of biannual house-to-house censuses, and verbal autopsies were done between May 26, 2015, and May 17, 2018, to identify cause of death. Cause-specific mortality, as assessed by verbal autopsy, was a prespecified secondary outcome. This trial is completed and is registered with ClinicalTrials.gov, NCT02047981. FINDINGS Between Nov 23, 2014, and July 31, 2017, 303 communities (n=40 375 children at baseline) in Niger received mass azithromycin and 291 communities (n=35 747 children at baseline) received placebo. Treatment coverage was 90·3% (SD 10·6) in the azithromycin group and 90·4% (10·1) in the placebo group. No communities were lost to follow-up. In total, 1727 child deaths in the azithromycin group and 1888 child deaths in the placebo group were reported from the population censuses. Of these, the cause of death for 1566 (90·7%) children in the azithromycin group and 1735 (91·9%) children in the placebo group were ascertained by verbal autopsy interviews. In the azithromycin group, 437 (27·9%) deaths were due to malaria, 252 (16·1%) deaths were due to pneumonia, and 234 (14·9%) deaths were due to diarrhoea. In the placebo group, 493 (28·4%) deaths were due to malaria, 275 (15·9%) deaths were due to pneumonia, and 251 (14·5%) deaths were due to diarrhoea. Relative to communities that received placebo, child mortality in communities that received azithromycin was lower for malaria (incidence rate ratio 0·78, 95% CI 0·66-0·92; p=0·0029), dysentery (0·65, 0·44-0·94; p=0·025), meningitis (0·67, 0·46-0·97; p=0·036), and pneumonia (0·83, 0·68-1·00; p=0·051). The distribution of causes of death did not differ significantly between the two study groups (p=0·98). INTERPRETATION Mass azithromycin distribution resulted in approximately a third fewer deaths in children aged 1-59 months due to meningitis and dysentery, and a fifth fewer deaths due to malaria and pneumonia. The lack of difference in the distribution of causes of death between the azithromycin and placebo groups could be attributable to the broad spectrum of azithromycin activity and the study setting, in which most childhood deaths were due to infections. FUNDING Bill & Melinda Gates Foundation.",2020,"Relative to communities that received placebo, child mortality in communities that received azithromycin was lower for malaria (incidence rate ratio 0·78, 95% CI 0·66-0·92; p=0·0029), dysentery (0·65, 0·44-0·94; p=0·025), meningitis (0·67, 0·46-0·97; p=0·036), and pneumonia (0·83, 0·68-1·00; p=0·051).","['deceased children using verbal autopsy', 'Between Nov 23, 2014, and July 31, 2017, 3615 child deaths', '594 community clusters in Niger', 'Between Nov 23, 2014, and July 31, 2017', ' 303 communities (n=40\u2008375 children at baseline) in Niger received mass', 'children younger than 5 years in communities receiving', 'and 291 communities (n=35\u2008747 children at baseline) received']","['oral azithromycin', 'placebo', 'azithromycin', 'biannual mass azithromycin']","['distribution of causes of death', 'Cause-specific mortality']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439824', 'cui_str': 'Verbal (qualifier value)'}, {'cui': 'C0004398', 'cui_str': 'Postmortem Examination'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0028074', 'cui_str': 'Republic of Niger'}, {'cui': 'C4517745', 'cui_str': '375 (qualifier value)'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}]","[{'cui': 'C0037775', 'cui_str': 'Distributions (qualifier value)'}, {'cui': 'C0007465', 'cui_str': 'Cause of Death'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0026566', 'cui_str': 'mortality'}]",594.0,0.47897,"Relative to communities that received placebo, child mortality in communities that received azithromycin was lower for malaria (incidence rate ratio 0·78, 95% CI 0·66-0·92; p=0·0029), dysentery (0·65, 0·44-0·94; p=0·025), meningitis (0·67, 0·46-0·97; p=0·036), and pneumonia (0·83, 0·68-1·00; p=0·051).","[{'ForeName': 'Jeremy D', 'Initials': 'JD', 'LastName': 'Keenan', 'Affiliation': 'Francis I Proctor Foundation, University of California, San Francisco, CA, USA; Department of Ophthalmology, University of California, San Francisco, CA, USA. Electronic address: jeremy.keenan@ucsf.edu.'}, {'ForeName': 'Ahmed M', 'Initials': 'AM', 'LastName': 'Arzika', 'Affiliation': 'The Carter Center Niger, Niamey, Niger.'}, {'ForeName': 'Ramatou', 'Initials': 'R', 'LastName': 'Maliki', 'Affiliation': 'The Carter Center Niger, Niamey, Niger.'}, {'ForeName': 'Sanoussi', 'Initials': 'S', 'LastName': 'Elh Adamou', 'Affiliation': 'The Carter Center Niger, Niamey, Niger.'}, {'ForeName': 'Fatima', 'Initials': 'F', 'LastName': 'Ibrahim', 'Affiliation': 'The Carter Center Niger, Niamey, Niger.'}, {'ForeName': 'Mariama', 'Initials': 'M', 'LastName': 'Kiemago', 'Affiliation': 'The Carter Center Niger, Niamey, Niger.'}, {'ForeName': 'Nana Fatima', 'Initials': 'NF', 'LastName': 'Galo', 'Affiliation': 'The Carter Center Niger, Niamey, Niger.'}, {'ForeName': 'Elodie', 'Initials': 'E', 'LastName': 'Lebas', 'Affiliation': 'Francis I Proctor Foundation, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Cook', 'Affiliation': 'Francis I Proctor Foundation, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Vanderschelden', 'Affiliation': 'Francis I Proctor Foundation, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Robin L', 'Initials': 'RL', 'LastName': 'Bailey', 'Affiliation': 'London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Sheila K', 'Initials': 'SK', 'LastName': 'West', 'Affiliation': 'Dana Center for Preventive Ophthalmology, Wilmer Eye Institute, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Travis C', 'Initials': 'TC', 'LastName': 'Porco', 'Affiliation': 'Francis I Proctor Foundation, University of California, San Francisco, CA, USA; Department of Ophthalmology, University of California, San Francisco, CA, USA; Department of Epidemiology & Biostatistics, University of California, San Francisco, CA, USA; Institute for Global Health Sciences, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Lietman', 'Affiliation': 'Francis I Proctor Foundation, University of California, San Francisco, CA, USA; Department of Ophthalmology, University of California, San Francisco, CA, USA; Department of Epidemiology & Biostatistics, University of California, San Francisco, CA, USA; Institute for Global Health Sciences, University of California, San Francisco, CA, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Global health,['10.1016/S2214-109X(19)30540-6'] 791,31550915,Effects of High-Dose Vitamin D Replacement on the Serum Levels of Systemic Inflammatory Biomarkers in Patients with Acute Exacerbation of Chronic Obstructive Pulmonary Disease.,"Chronic Obstructive Pulmonary Disease (COPD) is associated with increased inflammatory responses to noxious particles, which can be further enhanced during Acute Exacerbation of COPD (AECOPD). Considering the important immunoregulatory function of vitamin D, high prevalence of Vitamin D Deficiency (VDD) in COPD patients and a negative link between vitamin D levels and inflammatory biomarkers, suggests the seemingly interesting mechanism of vitamin D effects on inflammation resolution during the conventional treatment of AECOPD. The admitted AECOPD patients with VDD were recruited and randomly allocated to receive either 300,000 IU of intramuscular vitamin D ( n  = 35) or placebo ( n  = 35). Primary outcomes included inflammation resolution dynamics, which were assessed by monitoring the serum levels of IL-6, IL-8, and hs-CRP. Symptom recovery was evaluated based on the modified Medical Research Council (mMRC) dyspnea scale on the 1st and 6th days of admission. Secondary outcomes included the length of hospital stay (LOS) and 30-day mortality rates. Inflammatory biomarkers were highest at Day 1. Baseline vitamin D levels were 11.25 ± 3.09 and 10.59 ± 3.90 ng/ml ( P  = 0.45), which reached 11.35 ± 3.16 and 18.17 ± 4.24 by Day 6 ( P  < 0.001) in the placebo and, vitamin-D groups, respectively. IL-6 levels significantly decreased in the vitamin-D vs. placebo group on the 6 th day ( P  = 0.02); however, no significant differences were observed in IL-8 ( P  = 0.15) and hs-CRP ( P  = 0.24) levels, mMRC scale ( P  = 0.45), LOS ( P  = 0.20), and mortality rates ( P  = 0.61). Vitamin D replacement as adjunctive therapy may accelerate inflammation resolution in hospitalized AECOPD patients. Further studies were needed to establish vitamin D exact role on inflammation resolution in AECOPD.",2019,"levels significantly decreased in the vitamin-D vs. placebo group on the 6 th day ( P  = 0.02); however, no significant differences were observed in IL-8","['COPD patients', 'Chronic Obstructive Pulmonary Disease (COPD', 'hospitalized AECOPD patients', 'Patients with Acute Exacerbation of Chronic Obstructive Pulmonary Disease', 'admitted AECOPD patients with VDD']","['IL-6', 'vitamin-D vs. placebo', 'Vitamin D replacement', 'intramuscular vitamin D', 'placebo', 'High-Dose Vitamin D Replacement']","['mortality rates', 'Baseline vitamin D levels', 'IL-8', 'modified Medical Research Council (mMRC) dyspnea scale', 'Symptom recovery', 'Inflammatory biomarkers', 'LOS', 'length of hospital stay (LOS) and 30-day mortality rates', 'mMRC scale', 'Serum Levels of Systemic Inflammatory Biomarkers', 'inflammation resolution dynamics', 'serum levels of IL-6, IL-8, and hs-CRP']","[{'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0340044', 'cui_str': 'Acute exacerbation of chronic obstructive airways disease (disorder)'}]","[{'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0442117', 'cui_str': 'Intramuscular (qualifier value)'}, {'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}]","[{'cui': 'C0205848', 'cui_str': 'Death Rate'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C0079816', 'cui_str': 'Medical Research'}, {'cui': 'C0013404', 'cui_str': 'Breathlessness'}, {'cui': 'C0222045'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}]",,0.500132,"levels significantly decreased in the vitamin-D vs. placebo group on the 6 th day ( P  = 0.02); however, no significant differences were observed in IL-8","[{'ForeName': 'Farzaneh', 'Initials': 'F', 'LastName': 'Dastan', 'Affiliation': 'Department of Clinical Pharmacy, School of Pharmacy, Shahid Beheshti University of Medical Sciences , Tehran , Iran.'}, {'ForeName': 'Jamshid', 'Initials': 'J', 'LastName': 'Salamzadeh', 'Affiliation': 'Department of Clinical Pharmacy, School of Pharmacy, Shahid Beheshti University of Medical Sciences , Tehran , Iran.'}, {'ForeName': 'Mouhamad Hassan', 'Initials': 'MH', 'LastName': 'Pourrashid', 'Affiliation': 'Department of Clinical Pharmacy, School of Pharmacy, Ardabil University of Medical Sciences , Ardabil , Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Edalatifard', 'Affiliation': 'Department of Internal Medicine, School of Medicine, Tehran University of Medical Sciences , Tehran , Iran.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Eslaminejad', 'Affiliation': 'Chronic Respiratory Disease Research Center, National Research Institute of Tuberculosis and Lung Disease (NRITLD), Shahid Beheshti University of Medical Sciences , Tehran , Iran.'}]",COPD,['10.1080/15412555.2019.1666812'] 792,31712321,Impaired Metabolic Flexibility to High-Fat Overfeeding Predicts Future Weight Gain in Healthy Adults.,"The ability to switch fuels for oxidation in response to changes in macronutrient composition of diet (metabolic flexibility) may be informative of individuals' susceptibility to weight gain. Seventy-nine healthy, weight-stable participants underwent 24-h assessments of energy expenditure and respiratory quotient (RQ) in a whole-room calorimeter during energy balance (EBL) (50% carbohydrate, 30% fat) and then during 24-h fasting and three 200% overfeeding diets in a crossover design. Metabolic flexibility was defined as the change in 24-h RQ from EBL during fasting and standard overfeeding (STOF) (50% carbohydrate, 30% fat), high-fat overfeeding (HFOF) (60% fat, 20% carbohydrate), and high-carbohydrate overfeeding (HCOF) (75% carbohydrate, 5% fat) diets. Free-living weight change was assessed after 6 and 12 months. Compared with EBL, RQ decreased on average by 9% during fasting and by 4% during HFOF but increased by 4% during STOF and by 8% during HCOF. A smaller decrease in RQ, reflecting a smaller increase in lipid oxidation rate, during HFOF but not during the other diets predicted greater weight gain at both 6 and 12 months. An impaired metabolic flexibility to acute HFOF can identify individuals prone to weight gain, indicating that an individual's capacity to oxidize dietary fat is a metabolic determinant of weight change.",2020,"Compared to EBL, RQ decreased on average by 9% during fasting and by 4% during HFOF, while increasing by 4% during STOF and by 8% during HCOF.","['Healthy Adults', 'Seventy-nine healthy, weight-stable participants underwent 24-h assessments of energy expenditure and respiratory quotient (RQ) in a whole-room calorimeter during energy balance (EBL; 50% carbohydrate, 30% fat) and then during 24-h fasting and three 200% overfeeding diets in a crossover design']",[],"['EBL, RQ', 'RQ', 'Free-living weight change', 'lipid oxidation rate', 'Metabolic flexibility', 'weight gain']","[{'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0424657', 'cui_str': 'Weight static'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0014272', 'cui_str': 'Energy Expenditure'}, {'cui': 'C0429702', 'cui_str': 'Respiratory quotient (observable entity)'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0242817', 'cui_str': 'Cross-Over Design'}]",[],"[{'cui': 'C0005911', 'cui_str': 'Body Weight Changes'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0030011', 'cui_str': 'Oxidation, function (observable entity)'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0043094', 'cui_str': 'Weight Gain'}]",79.0,0.0186324,"Compared to EBL, RQ decreased on average by 9% during fasting and by 4% during HFOF, while increasing by 4% during STOF and by 8% during HCOF.","[{'ForeName': 'Brittany', 'Initials': 'B', 'LastName': 'Begaye', 'Affiliation': 'Obesity and Diabetes Clinical Research Section, Phoenix Epidemiology and Clinical Research Branch, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Department of Health and Human Services, Phoenix, AZ.'}, {'ForeName': 'Karyne L', 'Initials': 'KL', 'LastName': 'Vinales', 'Affiliation': 'Obesity and Diabetes Clinical Research Section, Phoenix Epidemiology and Clinical Research Branch, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Department of Health and Human Services, Phoenix, AZ.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Hollstein', 'Affiliation': 'Obesity and Diabetes Clinical Research Section, Phoenix Epidemiology and Clinical Research Branch, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Department of Health and Human Services, Phoenix, AZ.'}, {'ForeName': 'Takafumi', 'Initials': 'T', 'LastName': 'Ando', 'Affiliation': 'Obesity and Diabetes Clinical Research Section, Phoenix Epidemiology and Clinical Research Branch, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Department of Health and Human Services, Phoenix, AZ.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Walter', 'Affiliation': 'Clinical Core Laboratory, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda, MD.'}, {'ForeName': 'Clifton', 'Initials': 'C', 'LastName': 'Bogardus', 'Affiliation': 'Obesity and Diabetes Clinical Research Section, Phoenix Epidemiology and Clinical Research Branch, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Department of Health and Human Services, Phoenix, AZ.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Krakoff', 'Affiliation': 'Obesity and Diabetes Clinical Research Section, Phoenix Epidemiology and Clinical Research Branch, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Department of Health and Human Services, Phoenix, AZ.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Piaggi', 'Affiliation': 'Obesity and Diabetes Clinical Research Section, Phoenix Epidemiology and Clinical Research Branch, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Department of Health and Human Services, Phoenix, AZ paolo.piaggi@gmail.com paolo.piaggi@nih.gov.'}]",Diabetes,['10.2337/db19-0719'] 793,31733181,Early Surgery or Conservative Care for Asymptomatic Aortic Stenosis.,"BACKGROUND The timing and indications for surgical intervention in asymptomatic patients with severe aortic stenosis remain controversial. METHODS In a multicenter trial, we randomly assigned 145 asymptomatic patients with very severe aortic stenosis (defined as an aortic-valve area of ≤0.75 cm 2 with either an aortic jet velocity of ≥4.5 m per second or a mean transaortic gradient of ≥50 mm Hg) to early surgery or to conservative care according to the recommendations of current guidelines. The primary end point was a composite of death during or within 30 days after surgery (often called operative mortality) or death from cardiovascular causes during the entire follow-up period. The major secondary end point was death from any cause during follow-up. RESULTS In the early-surgery group, 69 of 73 patients (95%) underwent surgery within 2 months after randomization, and there was no operative mortality. In an intention-to-treat analysis, a primary end-point event occurred in 1 patient in the early-surgery group (1%) and in 11 of 72 patients in the conservative-care group (15%) (hazard ratio, 0.09; 95% confidence interval [CI], 0.01 to 0.67; P = 0.003). Death from any cause occurred in 5 patients in the early-surgery group (7%) and in 15 patients in the conservative-care group (21%) (hazard ratio, 0.33; 95% CI, 0.12 to 0.90). In the conservative-care group, the cumulative incidence of sudden death was 4% at 4 years and 14% at 8 years. CONCLUSIONS Among asymptomatic patients with very severe aortic stenosis, the incidence of the composite of operative mortality or death from cardiovascular causes during the follow-up period was significantly lower among those who underwent early aortic-valve replacement surgery than among those who received conservative care. (Funded by the Korean Institute of Medicine; RECOVERY ClinicalTrials.gov number, NCT01161732.).",2020,"Among asymptomatic patients with very severe aortic stenosis, the incidence of the composite of operative mortality or death from cardiovascular causes during the follow-up period was significantly lower among those who underwent early aortic-valve replacement surgery than among those who received conservative care.","['asymptomatic patients with severe aortic stenosis remain controversial', 'asymptomatic patients with very severe aortic stenosis', '145 asymptomatic patients with very severe aortic stenosis (defined as an aortic-valve area of ≤0.75 cm 2 with either an aortic jet velocity of ≥4.5 m per second or a mean transaortic gradient of ≥50 mm Hg) to early surgery or to conservative care according to the recommendations of current guidelines', 'Asymptomatic Aortic Stenosis']",['Early Surgery or Conservative Care'],"['operative mortality or death from cardiovascular causes', 'composite of death during or within 30 days after surgery (often called operative mortality) or death from cardiovascular causes', 'operative mortality', 'Death', 'cumulative incidence of sudden death', 'death from any cause during follow-up']","[{'cui': 'C0231221', 'cui_str': 'Asymptomatic (finding)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0003507', 'cui_str': 'Aortic Stenosis'}, {'cui': 'C3641272', 'cui_str': 'Extreme'}, {'cui': 'C4517577', 'cui_str': '145'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0428817', 'cui_str': 'Aortic valve area (observable entity)'}, {'cui': 'C0003483', 'cui_str': 'Aorta'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C0565930', 'cui_str': '/s'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0442339', 'cui_str': 'Transaortic approach (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0220845', 'cui_str': 'guidelines'}]","[{'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0011071', 'cui_str': 'Sudden death (event)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]",145.0,0.127712,"Among asymptomatic patients with very severe aortic stenosis, the incidence of the composite of operative mortality or death from cardiovascular causes during the follow-up period was significantly lower among those who underwent early aortic-valve replacement surgery than among those who received conservative care.","[{'ForeName': 'Duk-Hyun', 'Initials': 'DH', 'LastName': 'Kang', 'Affiliation': 'From the Division of Cardiology (D.-H. Kang, S.-A.L., S.L., D.-H. Kim, J.-M.S., J.-K.S.) and the Departments of Cardiothoracic Surgery (C.-H.C., J.-W.L.) and Biostatistics (S.-C.Y.), Asan Medical Center, College of Medicine, University of Ulsan, the Division of Cardiology, Samsung Medical Center, Sungkyunkwan University School of Medicine (S.-J.P., S.-W.P.), the Division of Cardiology, Severance Hospital (G.-R.H.), and the Cardiovascular Center, Seoul National University Hospital (H.-K.K.) - all in Seoul, South Korea.'}, {'ForeName': 'Sung-Ji', 'Initials': 'SJ', 'LastName': 'Park', 'Affiliation': 'From the Division of Cardiology (D.-H. Kang, S.-A.L., S.L., D.-H. Kim, J.-M.S., J.-K.S.) and the Departments of Cardiothoracic Surgery (C.-H.C., J.-W.L.) and Biostatistics (S.-C.Y.), Asan Medical Center, College of Medicine, University of Ulsan, the Division of Cardiology, Samsung Medical Center, Sungkyunkwan University School of Medicine (S.-J.P., S.-W.P.), the Division of Cardiology, Severance Hospital (G.-R.H.), and the Cardiovascular Center, Seoul National University Hospital (H.-K.K.) - all in Seoul, South Korea.'}, {'ForeName': 'Seung-Ah', 'Initials': 'SA', 'LastName': 'Lee', 'Affiliation': 'From the Division of Cardiology (D.-H. Kang, S.-A.L., S.L., D.-H. Kim, J.-M.S., J.-K.S.) and the Departments of Cardiothoracic Surgery (C.-H.C., J.-W.L.) and Biostatistics (S.-C.Y.), Asan Medical Center, College of Medicine, University of Ulsan, the Division of Cardiology, Samsung Medical Center, Sungkyunkwan University School of Medicine (S.-J.P., S.-W.P.), the Division of Cardiology, Severance Hospital (G.-R.H.), and the Cardiovascular Center, Seoul National University Hospital (H.-K.K.) - all in Seoul, South Korea.'}, {'ForeName': 'Sahmin', 'Initials': 'S', 'LastName': 'Lee', 'Affiliation': 'From the Division of Cardiology (D.-H. Kang, S.-A.L., S.L., D.-H. Kim, J.-M.S., J.-K.S.) and the Departments of Cardiothoracic Surgery (C.-H.C., J.-W.L.) and Biostatistics (S.-C.Y.), Asan Medical Center, College of Medicine, University of Ulsan, the Division of Cardiology, Samsung Medical Center, Sungkyunkwan University School of Medicine (S.-J.P., S.-W.P.), the Division of Cardiology, Severance Hospital (G.-R.H.), and the Cardiovascular Center, Seoul National University Hospital (H.-K.K.) - all in Seoul, South Korea.'}, {'ForeName': 'Dae-Hee', 'Initials': 'DH', 'LastName': 'Kim', 'Affiliation': 'From the Division of Cardiology (D.-H. Kang, S.-A.L., S.L., D.-H. Kim, J.-M.S., J.-K.S.) and the Departments of Cardiothoracic Surgery (C.-H.C., J.-W.L.) and Biostatistics (S.-C.Y.), Asan Medical Center, College of Medicine, University of Ulsan, the Division of Cardiology, Samsung Medical Center, Sungkyunkwan University School of Medicine (S.-J.P., S.-W.P.), the Division of Cardiology, Severance Hospital (G.-R.H.), and the Cardiovascular Center, Seoul National University Hospital (H.-K.K.) - all in Seoul, South Korea.'}, {'ForeName': 'Hyung-Kwan', 'Initials': 'HK', 'LastName': 'Kim', 'Affiliation': 'From the Division of Cardiology (D.-H. Kang, S.-A.L., S.L., D.-H. Kim, J.-M.S., J.-K.S.) and the Departments of Cardiothoracic Surgery (C.-H.C., J.-W.L.) and Biostatistics (S.-C.Y.), Asan Medical Center, College of Medicine, University of Ulsan, the Division of Cardiology, Samsung Medical Center, Sungkyunkwan University School of Medicine (S.-J.P., S.-W.P.), the Division of Cardiology, Severance Hospital (G.-R.H.), and the Cardiovascular Center, Seoul National University Hospital (H.-K.K.) - all in Seoul, South Korea.'}, {'ForeName': 'Sung-Cheol', 'Initials': 'SC', 'LastName': 'Yun', 'Affiliation': 'From the Division of Cardiology (D.-H. Kang, S.-A.L., S.L., D.-H. Kim, J.-M.S., J.-K.S.) and the Departments of Cardiothoracic Surgery (C.-H.C., J.-W.L.) and Biostatistics (S.-C.Y.), Asan Medical Center, College of Medicine, University of Ulsan, the Division of Cardiology, Samsung Medical Center, Sungkyunkwan University School of Medicine (S.-J.P., S.-W.P.), the Division of Cardiology, Severance Hospital (G.-R.H.), and the Cardiovascular Center, Seoul National University Hospital (H.-K.K.) - all in Seoul, South Korea.'}, {'ForeName': 'Geu-Ru', 'Initials': 'GR', 'LastName': 'Hong', 'Affiliation': 'From the Division of Cardiology (D.-H. Kang, S.-A.L., S.L., D.-H. Kim, J.-M.S., J.-K.S.) and the Departments of Cardiothoracic Surgery (C.-H.C., J.-W.L.) and Biostatistics (S.-C.Y.), Asan Medical Center, College of Medicine, University of Ulsan, the Division of Cardiology, Samsung Medical Center, Sungkyunkwan University School of Medicine (S.-J.P., S.-W.P.), the Division of Cardiology, Severance Hospital (G.-R.H.), and the Cardiovascular Center, Seoul National University Hospital (H.-K.K.) - all in Seoul, South Korea.'}, {'ForeName': 'Jong-Min', 'Initials': 'JM', 'LastName': 'Song', 'Affiliation': 'From the Division of Cardiology (D.-H. Kang, S.-A.L., S.L., D.-H. Kim, J.-M.S., J.-K.S.) and the Departments of Cardiothoracic Surgery (C.-H.C., J.-W.L.) and Biostatistics (S.-C.Y.), Asan Medical Center, College of Medicine, University of Ulsan, the Division of Cardiology, Samsung Medical Center, Sungkyunkwan University School of Medicine (S.-J.P., S.-W.P.), the Division of Cardiology, Severance Hospital (G.-R.H.), and the Cardiovascular Center, Seoul National University Hospital (H.-K.K.) - all in Seoul, South Korea.'}, {'ForeName': 'Cheol-Hyun', 'Initials': 'CH', 'LastName': 'Chung', 'Affiliation': 'From the Division of Cardiology (D.-H. Kang, S.-A.L., S.L., D.-H. Kim, J.-M.S., J.-K.S.) and the Departments of Cardiothoracic Surgery (C.-H.C., J.-W.L.) and Biostatistics (S.-C.Y.), Asan Medical Center, College of Medicine, University of Ulsan, the Division of Cardiology, Samsung Medical Center, Sungkyunkwan University School of Medicine (S.-J.P., S.-W.P.), the Division of Cardiology, Severance Hospital (G.-R.H.), and the Cardiovascular Center, Seoul National University Hospital (H.-K.K.) - all in Seoul, South Korea.'}, {'ForeName': 'Jae-Kwan', 'Initials': 'JK', 'LastName': 'Song', 'Affiliation': 'From the Division of Cardiology (D.-H. Kang, S.-A.L., S.L., D.-H. Kim, J.-M.S., J.-K.S.) and the Departments of Cardiothoracic Surgery (C.-H.C., J.-W.L.) and Biostatistics (S.-C.Y.), Asan Medical Center, College of Medicine, University of Ulsan, the Division of Cardiology, Samsung Medical Center, Sungkyunkwan University School of Medicine (S.-J.P., S.-W.P.), the Division of Cardiology, Severance Hospital (G.-R.H.), and the Cardiovascular Center, Seoul National University Hospital (H.-K.K.) - all in Seoul, South Korea.'}, {'ForeName': 'Jae-Won', 'Initials': 'JW', 'LastName': 'Lee', 'Affiliation': 'From the Division of Cardiology (D.-H. Kang, S.-A.L., S.L., D.-H. Kim, J.-M.S., J.-K.S.) and the Departments of Cardiothoracic Surgery (C.-H.C., J.-W.L.) and Biostatistics (S.-C.Y.), Asan Medical Center, College of Medicine, University of Ulsan, the Division of Cardiology, Samsung Medical Center, Sungkyunkwan University School of Medicine (S.-J.P., S.-W.P.), the Division of Cardiology, Severance Hospital (G.-R.H.), and the Cardiovascular Center, Seoul National University Hospital (H.-K.K.) - all in Seoul, South Korea.'}, {'ForeName': 'Seung-Woo', 'Initials': 'SW', 'LastName': 'Park', 'Affiliation': 'From the Division of Cardiology (D.-H. Kang, S.-A.L., S.L., D.-H. Kim, J.-M.S., J.-K.S.) and the Departments of Cardiothoracic Surgery (C.-H.C., J.-W.L.) and Biostatistics (S.-C.Y.), Asan Medical Center, College of Medicine, University of Ulsan, the Division of Cardiology, Samsung Medical Center, Sungkyunkwan University School of Medicine (S.-J.P., S.-W.P.), the Division of Cardiology, Severance Hospital (G.-R.H.), and the Cardiovascular Center, Seoul National University Hospital (H.-K.K.) - all in Seoul, South Korea.'}]",The New England journal of medicine,['10.1056/NEJMoa1912846'] 794,31977324,Increased Muscle Strength Limits Postural Sway During Daily Living Activities in Total Hip Arthroplasty Patients.,"OBJECTIVE The aim of the study was to investigate the effect of maximal strength training on postural sway after total hip arthroplasty, performed before and after a battery of physical performance tests that resemble daily living activities. DESIGN This study is an exploratory study based on data from a 3-mo randomized controlled trial involving 54 total hip arthroplasty patients performing maximal strength training or conventional rehabilitation. At 3, 6, and 12 mos postoperatively, postural sway was evaluated in two gait tests; ie, one test before and one test after conducting a battery of physical performance tests. RESULTS At 3 mos postoperatively, postural sway in the test after was significantly higher for the conventional rehabilitation group than the maximal strength training group (P = 0.045); however, there was no between-group difference at the test before (P = 0.670). Postural sway was also significantly higher in the test after compared with the test before in the conventional rehabilitation group (P < 0.001). No difference was found between the test before and test after in the maximal strength training group (P = 0.713). At 6 and 12 mos postoperatively, there were no statistically significant within- or between-group differences in postural sway. CONCLUSIONS Increased muscular strength limits postural sway 3 mos postoperatively in total hip arthroplasty patients after a demanding battery of physical performance tests simulating daily living activities.",2020,"At 6 and 12 months postoperatively, there were no statistically significant within- or between-group differences in postural sway. ","['total hip arthroplasty patients', 'postural sway after total hip arthroplasty (THA', '54 THA patients performing']","['MST or conventional rehabilitation (CR', 'MST', 'maximal strength training (MST']","['postural sway in the TA', 'postural sway', 'Postural sway', 'TB and TA']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0186193', 'cui_str': 'Arthroplasty of coxofemoral joint'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205278', 'cui_str': 'Postural (qualifier value)'}, {'cui': 'C0642413', 'cui_str': 'THAS'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}]","[{'cui': 'C0205278', 'cui_str': 'Postural (qualifier value)'}]",54.0,0.0278132,"At 6 and 12 months postoperatively, there were no statistically significant within- or between-group differences in postural sway. ","[{'ForeName': 'Siri B', 'Initials': 'SB', 'LastName': 'Winther', 'Affiliation': 'From the Orthopedic Research Centre, Department of Orthopedic Surgery, Clinic of Orthopedics, Rheumatology and Dermatology, St. Olavs Hospital HF, Trondheim, Norway (SBW, OAF, JK); Department of Neuromedicine and Movement Science, Faculty of Medicine and Health Science, NTNU, Norwegian University of Science and Technology, Trondheim, Norway (SBW, OAF); Department of Orthopedic Surgery, Clinic of Orthopedics, Rheumatology and Dermatology, St. Olavs Hospital HF, Trondheim, Norway (SBW, OAF, JK, VSH); Department of Circulation and Medical Imaging, Faculty of Medicine and Health Science, NTNU, Norwegian University of Science and Technology, Trondheim, Norway (VSH); and OsloMet - Oslo Metropolitan University, Faculty of Health Sciences, Institute of Nursing, Oslo, Norway (VSH).'}, {'ForeName': 'Olav A', 'Initials': 'OA', 'LastName': 'Foss', 'Affiliation': ''}, {'ForeName': 'Jomar', 'Initials': 'J', 'LastName': 'Klaksvik', 'Affiliation': ''}, {'ForeName': 'Vigdis S', 'Initials': 'VS', 'LastName': 'Husby', 'Affiliation': ''}]",American journal of physical medicine & rehabilitation,['10.1097/PHM.0000000000001382'] 795,31954158,Patient-centered change in the day-to-day impact of postmenopausal vaginal symptoms: results from a multicenter randomized trial.,"BACKGROUND Vulvovaginal symptoms, which include dryness, irritation, and pain with intercourse, are common among postmenopausal women and are associated with impaired sexual functioning and quality of life. Previous assessment of treatment strategies for these symptoms has been limited by a lack of sensitive patient-centered outcome measures that assess symptom impact on functional and quality-of-life domains. OBJECTIVE We aimed to (1) examine change in the impact of postmenopausal vulvovaginal symptoms on multiple aspects of well-being and functioning in relation to vaginal estradiol and moisturizer treatment and (2) guide meaningful interpretation of scores on a structured-item questionnaire measure of condition-specific impact. STUDY DESIGN Data were drawn from postmenopausal women who were enrolled in the Menopause Strategies: Finding Lasting Answers for Symptoms and Health Vaginal Health Trial (a 12-week, double-blind, placebo-controlled randomized trial of treatment for vulvovaginal symptoms) who were assigned to vaginal 10-μg estradiol tablet plus placebo gel (n=98), vaginal moisturizer plus placebo tablet (n=97), or dual placebo (n=94). At baseline and 12-week follow up, participants completed the Day-to-Day Impact of Vaginal Aging questionnaire to assess the impact of vaginal symptoms on 4 domains (activities of daily living, emotional well-being, sexual functioning, and body image), each on a 0-4 point scale. Day-to-Day Impact of Vaginal Aging sensitivity to change was assessed by the examination of the associations between change in Day-to-Day Impact of Vaginal Aging domain scores and vulvovaginal symptom severity from baseline to 12 weeks with analysis of covariance. Within-woman and between-group minimal clinically important improvement was assessed with the use of an anchor-based approach that relates change in Day-to-Day Impact of Vaginal Aging domain scores with self-reported benefit from treatment. RESULTS Participants in all treatment arms (n=289) demonstrated reduced impact of vulvovaginal symptoms on all domains of well-being and functioning as assessed by Day-to-Day Impact of Vaginal Aging at 12-week follow up, with no significant differences in improvement between women who were assigned to either estradiol tablet or vaginal moisturizer compared with placebo. For all Day-to-Day Impact of Vaginal Aging domains, mean impact scores were reduced when participants reported symptom improvement (-0.3 to -0.8 point change in Day-to-Day Impact of Vaginal Aging scores for <2-point symptom severity change vs -0.4 to -1.6 point change in Day-to-Day Impact of Vaginal Aging scores for 2+ point symptom severity change; all P<.001). Minimal clinically important change in Day-to-Day Impact of Vaginal Aging domain scale scores, which are anchored to self-reported meaningful benefit from treatment at 12 weeks, ranged from -0.4 to -1.3 (within-woman) and -0.2 to -0.7 (between-group). Observed change and minimal clinically important difference were largest for the sexual functioning domain. CONCLUSION The impact of vulvovaginal symptoms on day-to-day activities, sexual function, emotional well-being, and body image may be improved with low-dose vaginal estradiol, moisturizer, or topical placebo. The Day-to-Day Impact of Vaginal Aging questionnaire demonstrates sensitivity to change with treatment of vulvovaginal symptoms, particularly Day-to-Day Impact of Vaginal Aging scales that focus on symptom impact on sexual functioning and body image. Minimal clinically important improvement in the impact of vulvovaginal symptoms as measured by the Day-to-Day Impact of Vaginal Aging can be defined with the use of these measures.",2020,,['Postmenopausal Vaginal Symptoms'],[],[],"[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C4521343', 'cui_str': 'Vaginal (intended site)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",[],[],,0.0982499,,"[{'ForeName': 'Carolyn J', 'Initials': 'CJ', 'LastName': 'Gibson', 'Affiliation': 'San Francisco VA Health Care System, San Francisco, CA; Department of Psychiatry, University of California, San Francisco, CA. Electronic address: Carolyn.Gibson2@va.gov.'}, {'ForeName': 'Alison J', 'Initials': 'AJ', 'LastName': 'Huang', 'Affiliation': 'Department of Medicine, University of California, San Francisco, CA.'}, {'ForeName': 'Joseph C', 'Initials': 'JC', 'LastName': 'Larson', 'Affiliation': 'Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, WA.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Mitchell', 'Affiliation': 'Vincent Obstetrics and Gynecology, Massachusetts General Hospital and Harvard Medical School, Boston, MA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Diem', 'Affiliation': 'Department of Medicine and Epidemiology and Community Health, University of Minnesota, Minneapolis, MN; Department of Medicine, Minneapolis VA Health Care System, Minneapolis, MN.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'LaCroix', 'Affiliation': 'Department of Family Medicine and Public Health, University of California, San Diego, CA.'}, {'ForeName': 'Katherine M', 'Initials': 'KM', 'LastName': 'Newton', 'Affiliation': 'Kaiser Permanente Washington Health Research Institute, Seattle, WA.'}, {'ForeName': 'Susan D', 'Initials': 'SD', 'LastName': 'Reed', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Washington, Seattle, WA.'}, {'ForeName': 'Katherine A', 'Initials': 'KA', 'LastName': 'Guthrie', 'Affiliation': 'Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, WA.'}]",American journal of obstetrics and gynecology,['10.1016/j.ajog.2019.12.270'] 796,30865304,The Effect of Contextual Risk Factors on the Effectiveness of Brief Personality-Targeted Interventions for Adolescent Alcohol Use and Misuse: A Cluster-Randomized Trial.,"BACKGROUND A range of school-based prevention programs has been developed and used to prevent, delay, or reduce alcohol use among adolescents. Most of these programs have been evaluated at the community-level impact. However, the effect of contextual risk factors has rarely been considered in the evaluation of these programs. The aim of this study was to investigate the potential moderating effects of 2 important contextual risk factors (i.e., socioeconomic status [SES] and peer victimization) on the effectiveness of the school-based personality-targeted interventions (Preventure program) in reducing adolescent alcohol use over a 2-year period using a cluster-randomized trial. METHODS High-risk adolescents were identified using personality scores on the Substance Use Risk Profile Scale and randomized to intervention and control groups. Two 90-minute cognitive behavioral therapy-based group sessions targeted 1 of 4 personality risk profiles: Anxiety Sensitivity, Hopelessness, Impulsivity, or Sensation Seeking. Multilevel linear modeling of alcohol use, binge drinking, and drinking-related harm was conducted to assess the moderating effect of baseline peer victimization and SES. RESULTS Results indicated that the Preventure program was equally beneficial to all adolescents, regardless of SES and victimization history, in terms of their alcohol outcomes and related harm. Receiving the intervention was additionally beneficial for adolescents reporting peer victimization regarding their alcohol-related harm compared to nonvictimized youth (β = -0.29, SE = 0.11, p = 0.014). CONCLUSIONS Findings suggest that the content of personality-targeted interventions is beneficial for all high-risk youth regardless of their SES or experience of peer victimization. The current study suggests that using targeted approaches, such as targeting underlying personality risk factors, may be the most appropriate substance use prevention strategy for high-risk youth, as it is beneficial for all high-risk youth regardless of their contextual risk factors.",2019,"Receiving the intervention was additionally beneficial for adolescents reporting peer victimization regarding their alcohol-related harm compared to nonvictimized youth (β = -0.29, SE = 0.11, p = 0.014). ",['High-risk adolescents'],"['2 important contextual risk factors (i.e., socioeconomic status [SES] and peer victimization', 'Contextual Risk Factors', 'school-based personality-targeted interventions (Preventure program', 'cognitive behavioral therapy-based group sessions targeted 1 of 4 personality risk profiles', 'Brief Personality-Targeted Interventions']","['Anxiety Sensitivity, Hopelessness, Impulsivity, or Sensation Seeking']","[{'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}]","[{'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0086996', 'cui_str': 'Socioeconomic Status'}, {'cui': 'C0376695', 'cui_str': 'Victimization'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0031208', 'cui_str': 'Personality'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0150041', 'cui_str': 'Feeling of hopelessness'}, {'cui': 'C0021125', 'cui_str': 'Impulsivity'}, {'cui': 'C0871336', 'cui_str': 'Sensation seeking'}]",,0.0274567,"Receiving the intervention was additionally beneficial for adolescents reporting peer victimization regarding their alcohol-related harm compared to nonvictimized youth (β = -0.29, SE = 0.11, p = 0.014). ","[{'ForeName': 'Hanie', 'Initials': 'H', 'LastName': 'Edalati', 'Affiliation': 'CHU Sainte-Justine Research Center, Montréal, Québec, Canada.'}, {'ForeName': 'Mohammad H', 'Initials': 'MH', 'LastName': 'Afzali', 'Affiliation': 'CHU Sainte-Justine Research Center, Montréal, Québec, Canada.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Castellanos-Ryan', 'Affiliation': 'École de Psychoéducation , Université de Montréal, Outremont, Québec, Canada.'}, {'ForeName': 'Patricia J', 'Initials': 'PJ', 'LastName': 'Conrod', 'Affiliation': 'CHU Sainte-Justine Research Center, Montréal, Québec, Canada.'}]","Alcoholism, clinical and experimental research",['10.1111/acer.14016'] 797,31950036,The Effects of Once-Weekly Dulaglutide and Insulin Glargine on Glucose Fluctuation in Poorly Oral-Antidiabetic Controlled Patients with Type 2 Diabetes Mellitus.,"Aim. To compare the effects of once-weekly Dulaglutide with once-daily glargine in poorly oral-antidiabetic controlled patients with type 2 diabetes mellitus (T2DM). Method. A total of 25 patients with T2DM admitted into Department of Endocrinology from December 2012 to August 2013 were randomly assigned into two groups: Dulaglutide group ( n = 16) and glargine group ( n = 9). All patients received either Dulaglutide or glargine treatments for 52 weeks. Continuous glucose monitoring systems (CGMS) were applied to them for two 72 h periods at before and after the treatment each. Patient general clinical data were collected and analyzed. Result. Fast blood glucose ( FBG) of the glargine group declined more significantly than the Dulaglutide group after treatment ( p < 0.05). The mean blood glucose (MBG), standard deviation of blood glucose (SDBG), mean amplitude of glycemic excursion (MAGE) within a day, the largest amplitude of glycemic excursion (LAGE), M -value, absolute means of daily difference (MODD) of glycemic excursion, the percentage of time (≤2.8 mmol/L, ≤3.9 mmol/L, ≥10.0 mmol/L, ≥13.9 mmol/L, 3.9-7.8 mmol/L, and 9-10.0 mmol/L), maximum glycemic value, and minimum glycemic value were similar between the two groups ( p > 0.05). The incidence of hypoglycemia was also similar between the two groups ( p > 0.05). Though serum levels of TNF- α , IL-6, and 8-PGF2 α all decreased, significant reduction was found in TNF- α and 8-PGF2 α . TNF- α was only significantly reduced in the Dulaglutide group, while 8-PGF2 α was seen in both groups. Conclusion. For T2DM patients with poorly controlled oral antidiabetic drugs, once-weekly Dulaglutide not only has the same effect on glucose fluctuation as once-daily glargine but also significantly reduced TNF- α and 8-PGF2 α after a 52 week treatment protocol. This trial is registered with ClinicalTrials.gov NCT01648582.",2019,"Though serum levels of TNF- α , IL-6, and 8-PGF2 α all decreased, significant reduction was found in TNF- α and 8-PGF2 α .","['Poorly Oral-Antidiabetic Controlled Patients with Type 2 Diabetes Mellitus', 'poorly oral-antidiabetic controlled patients with type 2 diabetes mellitus (T2DM', '25 patients with T2DM admitted into Department of Endocrinology from December 2012 to August 2013']","['Once-Weekly Dulaglutide and Insulin Glargine', 'Continuous glucose monitoring systems (CGMS', 'Dulaglutide group ( n = 16) and glargine', 'once-weekly Dulaglutide with once-daily glargine', 'Dulaglutide or glargine']","['maximum glycemic value, and minimum glycemic value', 'largest amplitude of glycemic excursion (LAGE), M -value, absolute means of daily difference (MODD) of glycemic excursion, the percentage of time', 'TNF- α and 8-PGF2 α', 'mean blood glucose (MBG), standard deviation of blood glucose (SDBG), mean amplitude of glycemic excursion (MAGE', 'Fast blood glucose ( FBG', 'incidence of hypoglycemia', '8-PGF2 α', 'serum levels of TNF- α , IL-6, and 8-PGF2 α', 'TNF- α', 'Glucose Fluctuation']","[{'cui': 'C0205169', 'cui_str': 'Bad (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0935929', 'cui_str': 'Antidiabetics'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0014137', 'cui_str': 'Endocrinology'}]","[{'cui': 'C0558293', 'cui_str': 'Once a week (qualifier value)'}, {'cui': 'C3179549', 'cui_str': 'dulaglutide'}, {'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0181904', 'cui_str': 'Monitor, device (physical object)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}]","[{'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0012471', 'cui_str': 'prostaglandin F2 alpha'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0231239', 'cui_str': 'Fluctuation'}]",2013.0,0.0211335,"Though serum levels of TNF- α , IL-6, and 8-PGF2 α all decreased, significant reduction was found in TNF- α and 8-PGF2 α .","[{'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Endocrinology, Nanjing First Hospital, Nanjing Medical University, Nanjing 210029, China.'}, {'ForeName': 'Hui-Qin', 'Initials': 'HQ', 'LastName': 'Li', 'Affiliation': 'Department of Endocrinology, Nanjing First Hospital, Nanjing Medical University, Nanjing 210029, China.'}, {'ForeName': 'Xiao-Hua', 'Initials': 'XH', 'LastName': 'Xu', 'Affiliation': 'Department of Endocrinology, Nanjing First Hospital, Nanjing Medical University, Nanjing 210029, China.'}, {'ForeName': 'Xiao-Cen', 'Initials': 'XC', 'LastName': 'Kong', 'Affiliation': 'Department of Endocrinology, Nanjing First Hospital, Nanjing Medical University, Nanjing 210029, China.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Sun', 'Affiliation': 'Department of Endocrinology, Nanjing First Hospital, Nanjing Medical University, Nanjing 210029, China.'}, {'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Jing', 'Affiliation': 'Department of Endocrinology, Nanjing First Hospital, Nanjing Medical University, Nanjing 210029, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Ye', 'Affiliation': 'National Heart Research Institute Singapore, National Heart Centre Singapore, Singapore.'}, {'ForeName': 'Xiao-Fei', 'Initials': 'XF', 'LastName': 'Su', 'Affiliation': 'Department of Endocrinology, Nanjing First Hospital, Nanjing Medical University, Nanjing 210029, China.'}, {'ForeName': 'Jian-Hua', 'Initials': 'JH', 'LastName': 'Ma', 'Affiliation': 'Department of Endocrinology, Nanjing First Hospital, Nanjing Medical University, Nanjing 210029, China.'}]",BioMed research international,['10.1155/2019/2682657'] 798,31957654,Long-term effects of cardiac rehabilitation on sleep apnea severity in patients with coronary artery disease.,"STUDY OBJECTIVES Sleep apnea (SA) is prevalent among patients with coronary artery disease (CAD) and increases cardiovascular risk. A previous study showed that 1 month of cardiac rehabilitation (CR) reduced severity of SA in patients with CAD by reducing fluid accumulation in the legs during the day and the amount of fluid shifting rostrally into the neck overnight. The aim of this study was to evaluate whether CR will lead to longer-term attenuation of SA in patients with CAD. METHODS Fifteen patients with CAD and SA who had participated in a 1-month randomized trial of the effects of exercise training on SA were followed up until they completed 6 months of CR (age: 65 ± 10 years; body mass index: 27.0 ± 3.9 kg/m²; apnea-hypopnea index [AHI]: 39.0 ± 16.7). The AHI was evaluated at baseline by polysomnography and then at 6 months by portable monitoring at home. Cardiorespiratory fitness (VO 2peak ) was evaluated via a graded cardiopulmonary exercise test at baseline and 6 months later. The 6-month CR program included once weekly, 90-minute, in-facility exercise sessions, and 4 days per week at-home exercise sessions. RESULTS After 6 months of CR, there was a 54% reduction in the AHI (30.5 ± 15.2 to 14.1 ± 7.5, P < .001). Body mass index remained unchanged, but VO 2peak increased by 27% (20.0 ± 6.1 to 26.0 ± 8.9 mL/kg/min, P = .04). CONCLUSIONS Participation in CR is associated with a significant long-term decrease in the severity of SA. This finding suggests that attenuation of SA by exercise could be a mechanism underlying reduced mortality following participation in CR in patients with CAD and SA. CLINICAL TRIAL REGISTRATION This study is registered at www.controlled-trials.com with identifier number ISRCTN50108373.",2020,"Body mass index remained unchanged, but VO 2peak increased by 27% (20.0 ± 6.1 to 26.0 ± 8.9 mL/kg/min, P = .04). ","['patients with coronary artery disease (CAD) and increases cardiovascular risk', 'patients with CAD', 'patients with coronary artery disease', 'patients with CAD and SA', 'Fifteen patients with CAD and SA who had participated']","['exercise training', 'cardiac rehabilitation', 'cardiac rehabilitation (CR']","['Body mass index', 'sleep apnea severity', 'Cardiorespiratory fitness (VO 2peak ', 'VO 2peak']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0700431', 'cui_str': 'Cardiovascular Rehabilitation'}]","[{'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0037315', 'cui_str': 'Sleep Hypopnea'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}]",,0.0969035,"Body mass index remained unchanged, but VO 2peak increased by 27% (20.0 ± 6.1 to 26.0 ± 8.9 mL/kg/min, P = .04). ","[{'ForeName': 'Monique', 'Initials': 'M', 'LastName': 'Mendelson', 'Affiliation': 'Sleep Research Laboratory, University Health Network Toronto Rehabilitation Institute, Toronto, Canada.'}, {'ForeName': 'Toru', 'Initials': 'T', 'LastName': 'Inami', 'Affiliation': 'Sleep Research Laboratory, University Health Network Toronto Rehabilitation Institute, Toronto, Canada.'}, {'ForeName': 'Owen', 'Initials': 'O', 'LastName': 'Lyons', 'Affiliation': 'Sleep Research Laboratory, University Health Network Toronto Rehabilitation Institute, Toronto, Canada.'}, {'ForeName': 'Hisham', 'Initials': 'H', 'LastName': 'Alshaer', 'Affiliation': 'Sleep Research Laboratory, University Health Network Toronto Rehabilitation Institute, Toronto, Canada.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Marzolini', 'Affiliation': 'Cardiac Rehabilitation and Prevention, University Health Network Toronto Rehabilitation Institute, Toronto, Canada.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Oh', 'Affiliation': 'Cardiac Rehabilitation and Prevention, University Health Network Toronto Rehabilitation Institute, Toronto, Canada.'}, {'ForeName': 'T Douglas', 'Initials': 'TD', 'LastName': 'Bradley', 'Affiliation': 'Sleep Research Laboratory, University Health Network Toronto Rehabilitation Institute, Toronto, Canada.'}]",Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine,['10.5664/jcsm.8124'] 799,31937274,A suicide prevention strategy for youth presenting to the emergency department with suicide related behaviour: protocol for a randomized controlled trial.,"BACKGROUND Suicide is a leading cause of death among adolescents in North America. Youth who present to the Emergency Department (ED) with acute suicidality are at increased risk for eventual death by suicide, thereby presenting an opportunity for secondary prevention of suicide. The current study evaluates the effectiveness of a standardized individual and family-based suicidal behaviour risk reduction intervention targeting adolescents at high-risk for suicide. METHODS A randomized controlled trial (RCT) will be conducted to evaluate the effectiveness of a manualized youth- and family- based suicide prevention strategy (SPS) as compared with case navigation (NAV) among adolescents aged 12 to 18 years of age who present to the ED with acute suicidal ideation (SI) or suicide risk behaviours (SRB). We will recruit 128 participants and compare psychiatric symptoms including SI/SRB, family communication, and functional impairment at baseline and follow-ups (post-intervention [6 weeks], 24 weeks). The primary outcome is change in suicidal ideation measured with the Suicide Ideation Questionnaire- Junior. SRBs are measured with the Suicide Behaviour Questionnaire. Secondary outcomes are change in depressive and anxious symptoms measured with semi-structured psychiatric interview and Screen for Child Anxiety Related Disorders; acute mental health crises measured by urgent medical (including ED) visits; family communication measured with Conflict Behaviour Questionnaire, functional impairment measured by Columbia Impairment Scale; cost effectiveness, and fidelity of implementation measured by audio recording and fidelity checklist. DISCUSSION Results of this study will inform a larger multi-centre RCT that will include both community and academic hospitals in urban and rural settings. Study results will be shared at international psychiatry and emergency medicine meetings, in local rounds, and via publication in academic journals and clinician-oriented newsletters. If effective, the intervention may provide a brief, scalable, and transportable treatment program that may be implemented in a variety of settings, including those in which access to children's mental health care services is challenging. TRIAL REGISTRATION ClinicalTrials.gov: NCT03488602, retrospectively registered April 4, 2018.",2020,"Youth who present to the Emergency Department (ED) with acute suicidality are at increased risk for eventual death by suicide, thereby presenting an opportunity for secondary prevention of suicide.","['Youth who present to the Emergency Department (ED) with acute suicidality', 'adolescents at high-risk for suicide', 'youth presenting to the emergency department with suicide related behaviour', '128 participants and compare psychiatric symptoms including SI/SRB, family communication, and functional impairment at baseline and follow-ups (post-intervention [6\u2009weeks], 24\u2009weeks', 'adolescents aged 12 to 18\u2009years of age who present to the ED with acute suicidal ideation (SI) or suicide risk behaviours (SRB', 'adolescents in North America']","['manualized youth- and family- based suicide prevention strategy (SPS', 'case navigation (NAV', 'standardized individual and family-based suicidal behaviour risk reduction intervention']","['change in suicidal ideation measured with the Suicide Ideation Questionnaire- Junior', 'Suicide Behaviour Questionnaire', 'change in depressive and anxious symptoms measured with semi-structured psychiatric interview and Screen for Child Anxiety Related Disorders; acute mental health crises measured by urgent medical (including ED) visits; family communication measured with Conflict Behaviour Questionnaire, functional impairment measured by Columbia Impairment Scale; cost effectiveness, and fidelity of implementation measured by audio recording and fidelity checklist']","[{'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0852733', 'cui_str': 'Suicide (accomplished)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0233401', 'cui_str': 'Psychiatric symptom (finding)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0424000', 'cui_str': 'Suicidal Ideation'}, {'cui': 'C0563664', 'cui_str': 'Suicide risk'}, {'cui': 'C0028405', 'cui_str': 'North America'}]","[{'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0204732', 'cui_str': 'Suicide prevention (procedure)'}, {'cui': 'C4255078', 'cui_str': 'SPS'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C1760428', 'cui_str': 'Suicidal behavior (finding)'}, {'cui': 'C1137094', 'cui_str': 'Risk Reduction'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0424000', 'cui_str': 'Suicidal Ideation'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0852733', 'cui_str': 'Suicide (accomplished)'}, {'cui': 'C0392348', 'cui_str': 'Ideation, function (observable entity)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205487', 'cui_str': 'Psychiatric (qualifier value)'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0231224', 'cui_str': 'Crisis (finding)'}, {'cui': 'C0439609', 'cui_str': 'Urgency (qualifier value)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0009671', 'cui_str': 'Conflict'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C0222045'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}]",128.0,0.25493,"Youth who present to the Emergency Department (ED) with acute suicidality are at increased risk for eventual death by suicide, thereby presenting an opportunity for secondary prevention of suicide.","[{'ForeName': 'Daphne J', 'Initials': 'DJ', 'LastName': 'Korczak', 'Affiliation': 'Department of Psychiatry, Hospital for Sick Children, , Toronto, ON, Canada. daphne.korczak@sickkids.ca.'}, {'ForeName': 'Yaron', 'Initials': 'Y', 'LastName': 'Finkelstein', 'Affiliation': 'Research Institute, Hospital for Sick Children, Toronto, ON, Canada.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Barwick', 'Affiliation': 'Research Institute, Hospital for Sick Children, Toronto, ON, Canada.'}, {'ForeName': 'Gloria', 'Initials': 'G', 'LastName': 'Chaim', 'Affiliation': 'Department of Psychiatry, Faculty of Medicine, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Cleverley', 'Affiliation': 'Department of Psychiatry, Faculty of Medicine, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Henderson', 'Affiliation': 'Department of Psychiatry, Faculty of Medicine, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Suneeta', 'Initials': 'S', 'LastName': 'Monga', 'Affiliation': 'Department of Psychiatry, Hospital for Sick Children, , Toronto, ON, Canada.'}, {'ForeName': 'Myla E', 'Initials': 'ME', 'LastName': 'Moretti', 'Affiliation': 'Clinical Trial Unit, Ontario Child Health Support Unit, Hospital for Sick Children, Toronto, ON, Canada.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Willan', 'Affiliation': 'Dalla Lana School of Public Health, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Szatmari', 'Affiliation': 'Department of Psychiatry, Hospital for Sick Children, , Toronto, ON, Canada.'}]",BMC psychiatry,['10.1186/s12888-019-2422-y'] 800,31632192,Brief behavioral treatment for insomnia in older adults with late-life treatment-resistant depression and insomnia: a pilot study.,"Objective Brief Behavioral Treatment for Insomnia (BBTI) is an efficacious treatment of insomnia in older adults. Behavioral treatments for insomnia can also improve depression. However, it is unknown if BBTI is feasible or has an effect in patients with insomnia and late-life treatment resistant depression (LLTRD). The aims of this study were two-fold, to test: 1) the feasibility (defined by acceptability and retention rates) of BBTI and 2) the therapeutic potency of BBTI on symptoms of insomnia and depression. Methods Eleven older Veterans with LLTRD and insomnia were recruited in a randomized control trial to receive immediate (4-weeks of BBTI followed by 3-weeks of phone call check-ins and a final in-person 8-week assessment) or delayed (3-weeks of treatment as usual [wait-list control] followed by 4-weeks of BBTI and a final in-person 8-week assessment) BBTI. The primary outcome measures included the Patient Health Questionnaire (minus the sleep item) and the Insomnia Severity Index. Results BBTI was found to be feasible in older Veterans with insomnia and LLTRD; all participants recommended BBTI and retention rates were 90.9%. There was no difference in treatment effect between the immediate BBTI and delayed BBTI groups at week 4. After both groups (immediate and delayed) received BBTI, improvements were seen in both insomnia ( d = 1.06) and depression ( d = 0.54) scores. Conclusions BBTI is a feasible treatment for insomnia in older adults with LLTRD. BBTI may be an effective adjunctive treatment for depression. Larger adequately-powered trials are required to confirm these preliminary findings.",2019,"Results BBTI was found to be feasible in older Veterans with insomnia and LLTRD; all participants recommended BBTI and retention rates were 90.9%.","['older adults with late-life treatment-resistant depression and insomnia', 'patients with insomnia and late-life treatment resistant depression (LLTRD', 'older adults', 'Eleven older Veterans with LLTRD and insomnia', 'older adults with LLTRD']","['immediate (4-weeks of BBTI followed by 3-weeks of phone call check-ins and a final in-person 8-week assessment) or delayed (3-weeks of treatment as usual [wait-list control] followed by 4-weeks of BBTI and a final in-person 8-week assessment) BBTI', 'Brief behavioral treatment']","['Patient Health Questionnaire (minus the sleep item) and the Insomnia Severity Index', 'depression', 'BBTI and retention rates']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C2063866', 'cui_str': 'Refractory Depression'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}]","[{'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}]","[{'cui': 'C1879301', 'cui_str': 'Patient Health Questionnaire'}, {'cui': 'C0332288', 'cui_str': 'Without (attribute)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C4520529', 'cui_str': 'Insomnia severity index (assessment scale)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0035280', 'cui_str': 'Retention'}]",11.0,0.0346045,"Results BBTI was found to be feasible in older Veterans with insomnia and LLTRD; all participants recommended BBTI and retention rates were 90.9%.","[{'ForeName': 'Marie Anne', 'Initials': 'MA', 'LastName': 'Gebara', 'Affiliation': 'Department of Psychiatry, University of Pittsburgh School of Medicine, Pittsburgh, PA; USA.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'DiNapoli', 'Affiliation': 'Mental Illness Research, Education and Clinical Center, VA Pittsburgh Healthcare System, Pittsburgh, PA; USA.'}, {'ForeName': 'Lisa G', 'Initials': 'LG', 'LastName': 'Lederer', 'Affiliation': 'Mental Illness Research, Education and Clinical Center, VA Pittsburgh Healthcare System, Pittsburgh, PA; USA.'}, {'ForeName': 'Adam D', 'Initials': 'AD', 'LastName': 'Bramoweth', 'Affiliation': 'Mental Illness Research, Education and Clinical Center, VA Pittsburgh Healthcare System, Pittsburgh, PA; USA.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Germain', 'Affiliation': 'Department of Psychiatry, University of Pittsburgh School of Medicine, Pittsburgh, PA; USA.'}, {'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'Kasckow', 'Affiliation': 'VA Beckley Healthcare System, Beckley, West Virginia; USA.'}, {'ForeName': 'Jordan F', 'Initials': 'JF', 'LastName': 'Karp', 'Affiliation': 'Department of Psychiatry, University of Pittsburgh School of Medicine, Pittsburgh, PA; USA.'}]",Sleep and biological rhythms,['10.1007/s41105-019-00211-6'] 801,31955921,A Self-management Approach for Dietary Sodium Restriction in Patients With CKD: A Randomized Controlled Trial.,"RATIONALE & OBJECTIVE Patients with chronic kidney disease (CKD) are particularly sensitive to dietary sodium. We evaluated a self-management approach for dietary sodium restriction in patients with CKD. STUDY DESIGN Randomized controlled trial. SETTING & PARTICIPANTS Nephrology outpatient clinics in 4 Dutch hospitals. 99 adults with CKD stages 1 to 4 or a functioning (estimated glomerular filtration rate≥25mL/min/1.73m 2 ) kidney transplant, hypertension, and sodium intake>130mmol/d. INTERVENTION Routine care was compared with routine care plus a web-based self-management intervention including individual e-coaching and group meetings implemented over a 3-month intervention period, followed by e-coaching over a 6-month maintenance period. OUTCOMES Primary outcomes were sodium excretion after the 3-month intervention and after the 6-month maintenance period. Secondary outcomes were blood pressure, proteinuria, costs, quality of life, self-management skills, and barriers and facilitators for implementation. RESULTS Baseline estimated glomerular filtration rate was 55.0±22.0mL/min/1.73m 2 . During the intervention period, sodium excretion decreased in the intervention group from 188±8 (SE) to 148±8mmol/d (P<0.001), but did not change significantly in the control group. At 3 months, mean sodium excretion was 24.8 (95% CI, 0.1-49.6) mmol/d lower in the intervention group (P=0.049). At 3 months, systolic blood pressure (SBP) decreased in the intervention group from 140±3 to 132±3mm Hg (P<0.001), but was unchanged in the control group. Mean difference in SBP across groups was-4.7 (95% CI, -10.7 to 1.3) mm Hg (P=0.1). During the maintenance phase, sodium excretion increased in the intervention group, but remained lower than at baseline at 160±8mmol/d (P=0.01), while it decreased in the control group from 174±9 at the end of the intervention period to 154±9mmol/d (P=0.001). Consequently, no difference in sodium excretion between groups was observed after the maintenance phase. There was no difference in SBP between groups after the maintenance phase. LIMITATIONS Limited power, postrandomization loss to follow-up, Hawthorne effect, lack of dietary data, short-term follow-up. CONCLUSIONS A coaching intervention reduced sodium intake at 3 months. Efficacy during the maintenance phase was diminished, possibly due to inadvertent adoption of the intervention by the control group. FUNDING Grant funding from the Netherlands Organization for Health Research and Development and the Dutch Kidney Foundation. TRIAL REGISTRATION Registered at ClinicalTrials.gov with study number NCT02132013.",2020,"At 3 months, mean sodium excretion was 24.8 (95% CI, 0.1-49.6) mmol/d lower in the intervention group (P=0.049).","['Nephrology outpatient clinics in 4 Dutch hospitals', 'patients with CKD', '99 adults with CKD stages 1 to 4 or a functioning (estimated glomerular filtration rate≥25mL/min/1.73m 2 ) kidney transplant, hypertension, and sodium intake>130mmol', 'Patients With CKD', 'Patients with chronic kidney disease (CKD']","['Routine care was compared with routine care plus a web-based self-management intervention including individual e-coaching and group meetings implemented over a 3-month intervention period, followed by e-coaching']","['blood pressure, proteinuria, costs, quality of life, self-management skills, and barriers and facilitators for implementation', 'sodium intake', 'systolic blood pressure (SBP', 'glomerular filtration rate', 'mean sodium excretion', 'SBP', 'sodium excretion', 'Efficacy', 'Mean difference in SBP']","[{'cui': 'C0027712', 'cui_str': 'Nephrology'}, {'cui': 'C0002424', 'cui_str': 'Outpatient Clinics'}, {'cui': 'C0013331', 'cui_str': 'Dutch (ethnic group)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C2316401', 'cui_str': 'CKD stage 1'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0232809', 'cui_str': 'Glomerular filtration, function (observable entity)'}, {'cui': 'C0022671', 'cui_str': 'Grafting, Kidney'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C3541959', 'cui_str': 'Sodium supplement (substance)'}, {'cui': 'C1561643', 'cui_str': 'Chronic Kidney Diseases'}]","[{'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0086969', 'cui_str': 'Self-Management'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0018261', 'cui_str': 'Group Meetings'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0557773', 'cui_str': 'Coach (physical object)'}]","[{'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0033687', 'cui_str': 'Proteinuria'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0034380'}, {'cui': 'C0086969', 'cui_str': 'Self-Management'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C3541959', 'cui_str': 'Sodium supplement (substance)'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0911267', 'cui_str': 'SBP protein, Papaver rhoeas'}, {'cui': 'C0017654', 'cui_str': 'Glomerular Filtration Rate'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0221102', 'cui_str': 'Excretory function (observable entity)'}]",99.0,0.0474961,"At 3 months, mean sodium excretion was 24.8 (95% CI, 0.1-49.6) mmol/d lower in the intervention group (P=0.049).","[{'ForeName': 'Jelmer K', 'Initials': 'JK', 'LastName': 'Humalda', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Gerald', 'Initials': 'G', 'LastName': 'Klaassen', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands. Electronic address: g.klaassen@umcg.nl.'}, {'ForeName': 'Hanne', 'Initials': 'H', 'LastName': 'de Vries', 'Affiliation': 'Department of Nephrology, ZGT Hospital, Almelo/Hengelo, the Netherlands.'}, {'ForeName': 'Yvette', 'Initials': 'Y', 'LastName': 'Meuleman', 'Affiliation': 'Department of Health, Medical and Neuropsychology, Faculty of Social and Behavioral Sciences, Leiden University, Leiden, the Netherlands; Department of Clinical Epidemiology, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Lara C', 'Initials': 'LC', 'LastName': 'Verschuur', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Elisabeth J M', 'Initials': 'EJM', 'LastName': 'Straathof', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Gozewijn D', 'Initials': 'GD', 'LastName': 'Laverman', 'Affiliation': 'Department of Nephrology, ZGT Hospital, Almelo/Hengelo, the Netherlands.'}, {'ForeName': 'Willem Jan W', 'Initials': 'WJW', 'LastName': 'Bos', 'Affiliation': 'Department of Internal Medicine, St. Antonius Hospital, Nieuwegein, the Netherlands; Department of Internal Medicine, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Paul J M', 'Initials': 'PJM', 'LastName': 'van der Boog', 'Affiliation': 'Department of Internal Medicine, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Karin M', 'Initials': 'KM', 'LastName': 'Vermeulen', 'Affiliation': 'Department of Epidemiology, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Olivier A', 'Initials': 'OA', 'LastName': 'Blanson Henkemans', 'Affiliation': 'Department of Child Health, Netherlands Organization for Applied Scientific Research (TNO), Leiden, the Netherlands.'}, {'ForeName': 'Wilma', 'Initials': 'W', 'LastName': 'Otten', 'Affiliation': 'Department of Child Health, Netherlands Organization for Applied Scientific Research (TNO), Leiden, the Netherlands.'}, {'ForeName': 'Martin H', 'Initials': 'MH', 'LastName': 'de Borst', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'van Dijk', 'Affiliation': 'Department of Health, Medical and Neuropsychology, Faculty of Social and Behavioral Sciences, Leiden University, Leiden, the Netherlands.'}, {'ForeName': 'Gerjan J', 'Initials': 'GJ', 'LastName': 'Navis', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American journal of kidney diseases : the official journal of the National Kidney Foundation,['10.1053/j.ajkd.2019.10.012'] 802,31816842,"Effect of a Euglena gracilis Fermentate on Immune Function in Healthy, Active Adults: A Randomized, Double-Blind, Placebo-Controlled Trial.","Euglena gracilis produce high amounts of algal β-1,3-glucan, which evoke an immune response when consumed. This study investigated the effect of supplementation with a proprietary Euglena gracilis fermentate (BG), containing greater than 50% β-1,3-glucan, on immune function as measured by self-reported changes in upper respiratory tract infection (URTI) symptoms. Thirty-four healthy, endurance-trained participants were randomized and received either 367 mg of BG or placebo (PLA) for 90 days. Symptoms were assessed by the 24-item Wisconsin Upper Respiratory Symptom Survey and safety via clinical chemistry, hematology, vitals, and adverse event reporting. Participants supplemented with BG over 90 days reported fewer sick days (BG: 1.46 ± 1.01; PLA: 4.79 ± 1.47 days; p = 0.041), fewer URTI symptoms (BG: 12.62 ± 5.92; PLA: 42.29 ± 13.17; p = 0.029), fewer symptom days (BG: 5.46 ± 1.89; PLA: 15.43 ± 4.59 days; p = 0.019), fewer episodes (BG: 2.62 ± 0.67; PLA: 4.79 ± 0.67; p = 0.032), and lower global severity measured as area under curve for URTI symptoms (BG: 17.50 ± 8.41; PLA: 89.79 ± 38.92; p = 0.0499) per person compared to placebo. Sick days, symptoms, and global severity were significantly ( p < 0.05) fewer over 30 days in the BG group compared to PLA. All safety outcomes were within clinically normal ranges. The study provides evidence that supplementation with a proprietary Euglena gracilis fermentate containing greater than 50% β-1,3-glucan may reduce and prevent URTI symptoms, providing immune support and protecting overall health.",2019,"Sick days, symptoms, and global severity were significantly ( p < 0.05) fewer over 30 days in the BG group compared to PLA.","['Healthy, Active Adults', 'Thirty-four healthy, endurance-trained participants']","['placebo', 'supplementation with a proprietary Euglena gracilis fermentate (BG), containing greater than 50% β-1,3-glucan', 'Placebo', 'Euglena gracilis Fermentate', 'BG or placebo (PLA']","['Sick days, symptoms, and global severity', 'Immune Function', 'lower global severity', '24-item Wisconsin Upper Respiratory Symptom Survey and safety via clinical chemistry, hematology, vitals, and adverse event reporting', 'upper respiratory tract infection (URTI) symptoms', 'fewer URTI symptoms', 'URTI symptoms']","[{'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0518031', 'cui_str': 'Endurance capacity'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0015154', 'cui_str': 'Euglenas'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0017692', 'cui_str': 'Glucan (BO)'}]","[{'cui': 'C0242806', 'cui_str': 'Sick Days'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0439662', 'cui_str': 'Immune (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0043193', 'cui_str': 'Wisconsin'}, {'cui': 'C0749874', 'cui_str': 'Upper respiratory symptom'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0008000', 'cui_str': 'Chemistry, Clinical'}, {'cui': 'C0018943', 'cui_str': 'Hematology'}, {'cui': 'C0442732', 'cui_str': 'Vital (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0041912', 'cui_str': 'Upper Respiratory Infections'}, {'cui': 'C0205388', 'cui_str': 'Few (qualifier value)'}]",34.0,0.624756,"Sick days, symptoms, and global severity were significantly ( p < 0.05) fewer over 30 days in the BG group compared to PLA.","[{'ForeName': 'Malkanthi', 'Initials': 'M', 'LastName': 'Evans', 'Affiliation': 'KGK Science, London, ON N6A 5R8, Canada.'}, {'ForeName': 'Paul H', 'Initials': 'PH', 'LastName': 'Falcone', 'Affiliation': 'Kemin Foods LC, Des Moines, IA 50317, USA.'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Crowley', 'Affiliation': 'KGK Science, London, ON N6A 5R8, Canada.'}, {'ForeName': 'Abdul M', 'Initials': 'AM', 'LastName': 'Sulley', 'Affiliation': 'KGK Science, London, ON N6A 5R8, Canada.'}, {'ForeName': 'Marybelle', 'Initials': 'M', 'LastName': 'Campbell', 'Affiliation': 'KGK Science, London, ON N6A 5R8, Canada.'}, {'ForeName': 'Nisrine', 'Initials': 'N', 'LastName': 'Zakaria', 'Affiliation': 'KGK Science, London, ON N6A 5R8, Canada.'}, {'ForeName': 'Joanne A', 'Initials': 'JA', 'LastName': 'Lasrado', 'Affiliation': 'Kemin Foods LC, Des Moines, IA 50317, USA.'}, {'ForeName': 'Emily Pankow', 'Initials': 'EP', 'LastName': 'Fritz', 'Affiliation': 'Kemin Foods LC, Des Moines, IA 50317, USA.'}, {'ForeName': 'Kelli A', 'Initials': 'KA', 'LastName': 'Herrlinger', 'Affiliation': 'Kemin Foods LC, Des Moines, IA 50317, USA.'}]",Nutrients,['10.3390/nu11122926'] 803,31816875,An Isocaloric Nordic Diet Modulates RELA and TNFRSF1A Gene Expression in Peripheral Blood Mononuclear Cells in Individuals with Metabolic Syndrome-A SYSDIET Sub-Study.,"A healthy dietary pattern is associated with a lower risk of metabolic syndrome (MetS) and reduced inflammation. To explore this at the molecular level, we investigated the effect of a Nordic diet (ND) on changes in the gene expression profiles of inflammatory and lipid-related genes in peripheral blood mononuclear cells (PBMCs) of individuals with MetS. We hypothesized that the intake of an ND compared to a control diet (CD) would alter the expression of inflammatory genes and genes involved in lipid metabolism. The individuals with MetS underwent an 18/24-week randomized intervention to compare a ND with a CD. Eighty-eight participants (66% women) were included in this sub-study of the larger SYSDIET study. Fasting PBMCs were collected before and after the intervention and changes in gene expression levels were measured using TaqMan Array Micro Fluidic Cards. Forty-eight pre-determined inflammatory and lipid related gene transcripts were analyzed. The expression level of the gene tumor necrosis factor (TNF) receptor superfamily member 1A (TNFRSF1A) was down-regulated ( p = 0.004), whereas the nuclear factor kappa-light-chain-enhancer of activated B cells (NF-κB) subunit, RELA proto-oncogene , was up-regulated ( p = 0.016) in the ND group compared to the CD group. In conclusion, intake of an ND in individuals with the MetS may affect immune function.",2019,"The expression level of the gene tumor necrosis factor (TNF) receptor superfamily member 1A (TNFRSF1A) was down-regulated ( p = 0.004), whereas the nuclear factor kappa-light-chain-enhancer of activated B cells (NF-κB) subunit, RELA proto-oncogene , was up-regulated ( p = 0.016) in the ND group compared to the CD group.","['individuals with MetS', 'Individuals with Metabolic Syndrome-A SYSDIET Sub-Study', 'Eighty-eight participants (66% women) were included in this sub-study of the larger SYSDIET study']","['control diet (CD', 'Nordic diet (ND']","['expression level of the gene tumor necrosis factor (TNF) receptor superfamily member 1A (TNFRSF1A', 'nuclear factor kappa-light-chain-enhancer of activated B cells (NF-κB) subunit, RELA proto-oncogene', 'gene expression levels', 'Fasting PBMCs']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0524620', 'cui_str': 'Metabolic Syndrome X'}, {'cui': 'C1264637', 'cui_str': 'Substance amount'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C4517898', 'cui_str': '88 (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}]","[{'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0017337', 'cui_str': 'Genes'}, {'cui': 'C0077503', 'cui_str': 'TNF Receptors'}, {'cui': 'C0021036', 'cui_str': 'Immunoglobulin kappa-Chains'}, {'cui': 'C0004561', 'cui_str': 'B-Cells'}, {'cui': 'C0033713', 'cui_str': 'Proto-Oncogenes'}, {'cui': 'C0017262', 'cui_str': 'Gene Expression'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}]",88.0,0.0220589,"The expression level of the gene tumor necrosis factor (TNF) receptor superfamily member 1A (TNFRSF1A) was down-regulated ( p = 0.004), whereas the nuclear factor kappa-light-chain-enhancer of activated B cells (NF-κB) subunit, RELA proto-oncogene , was up-regulated ( p = 0.016) in the ND group compared to the CD group.","[{'ForeName': 'Stine M', 'Initials': 'SM', 'LastName': 'Ulven', 'Affiliation': 'Department of Nutrition, Institute for Basic Medical Sciences, University of Oslo, 0317 Oslo, Norway.'}, {'ForeName': 'Kirsten B', 'Initials': 'KB', 'LastName': 'Holven', 'Affiliation': 'Department of Nutrition, Institute for Basic Medical Sciences, University of Oslo, 0317 Oslo, Norway.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Rundblad', 'Affiliation': 'Department of Nutrition, Institute for Basic Medical Sciences, University of Oslo, 0317 Oslo, Norway.'}, {'ForeName': 'Mari C W', 'Initials': 'MCW', 'LastName': 'Myhrstad', 'Affiliation': 'Department of Nursing and Health Promotion, Faculty of Health Sciences, OsloMet-Oslo Metropolitan University, 0130 Oslo, Norway.'}, {'ForeName': 'Lena', 'Initials': 'L', 'LastName': 'Leder', 'Affiliation': 'Mills AS, Sofienberggt. 19, 0558 Oslo, Norway.'}, {'ForeName': 'Ingrid', 'Initials': 'I', 'LastName': 'Dahlman', 'Affiliation': 'Department of Medicine (H7), Karolinska Institute, 17176 Stockholm, Sweden.'}, {'ForeName': 'Vanessa D de', 'Initials': 'VD', 'LastName': 'Mello', 'Affiliation': 'School of Medicine, Institute of Public Health and Clinical Nutrition, University of Eastern Finland, 70211 Kuopio, Finland.'}, {'ForeName': 'Ursula', 'Initials': 'U', 'LastName': 'Schwab', 'Affiliation': 'School of Medicine, Institute of Public Health and Clinical Nutrition, University of Eastern Finland, 70211 Kuopio, Finland.'}, {'ForeName': 'Carsten', 'Initials': 'C', 'LastName': 'Carlberg', 'Affiliation': 'Institute of Biomedicine, University of Eastern Finland, 70211 Kuopio, Finland.'}, {'ForeName': 'Jussi', 'Initials': 'J', 'LastName': 'Pihlajamäki', 'Affiliation': 'School of Medicine, Institute of Public Health and Clinical Nutrition, University of Eastern Finland, 70211 Kuopio, Finland.'}, {'ForeName': 'Kjeld', 'Initials': 'K', 'LastName': 'Hermansen', 'Affiliation': 'Department of Endocrinology and Internal Medicine, Department of Clinical Medicine, Aarhus University Hospital, Aarhus University, 8200 Aarhus, Denmark.'}, {'ForeName': 'Lars O', 'Initials': 'LO', 'LastName': 'Dragsted', 'Affiliation': 'Department of Nutrition, Exercise and Sports, Faculty of Science, University of Copenhagen, 2200 Copenhagen, Denmark.'}, {'ForeName': 'Ingibjörg', 'Initials': 'I', 'LastName': 'Gunnarsdottir', 'Affiliation': 'Unit for Nutrition Research, University of Iceland and Landspitali-The National University Hospital of Iceland, 101 Reykjavík, Iceland.'}, {'ForeName': 'Lieselotte', 'Initials': 'L', 'LastName': 'Cloetens', 'Affiliation': 'Biomedical Nutrition, Pure and Applied Biochemistry, Lund University, 221 00 Lund, Sweden.'}, {'ForeName': 'Björn', 'Initials': 'B', 'LastName': 'Åkesson', 'Affiliation': 'Biomedical Nutrition, Pure and Applied Biochemistry, Lund University, 221 00 Lund, Sweden.'}, {'ForeName': 'Fredrik', 'Initials': 'F', 'LastName': 'Rosqvist', 'Affiliation': 'Department of Public Health and Caring Sciences, Clinical Nutrition and Metabolism, Uppsala University, 751 22 Uppsala, Sweden.'}, {'ForeName': 'Janne', 'Initials': 'J', 'LastName': 'Hukkanen', 'Affiliation': 'Institute of Clinical Medicine, Department of Internal Medicine and Biocenter Oulu, University of Oulu, Medical Research Center, Oulu University Hospital, 90220 Oulu, Finland.'}, {'ForeName': 'Karl-Heinz', 'Initials': 'KH', 'LastName': 'Herzig', 'Affiliation': 'Institute of Biomedicine, Biocenter of Oulu, Medical Research Center, Faculty of Medicine, University of Oulu, and Oulu University Hospital, 90220 Oulu, Finland.'}, {'ForeName': 'Markku J', 'Initials': 'MJ', 'LastName': 'Savolainen', 'Affiliation': 'Institute of Clinical Medicine, Department of Internal Medicine and Biocenter Oulu, University of Oulu, Medical Research Center, Oulu University Hospital, 90220 Oulu, Finland.'}, {'ForeName': 'Ulf', 'Initials': 'U', 'LastName': 'Risérus', 'Affiliation': 'Department of Public Health and Caring Sciences, Clinical Nutrition and Metabolism, Uppsala University, 751 22 Uppsala, Sweden.'}, {'ForeName': 'Inga', 'Initials': 'I', 'LastName': 'Thorsdottir', 'Affiliation': 'Unit for Nutrition Research, University of Iceland and Landspitali-The National University Hospital of Iceland, 101 Reykjavík, Iceland.'}, {'ForeName': 'Kaisa S', 'Initials': 'KS', 'LastName': 'Poutanen', 'Affiliation': 'School of Medicine, Institute of Public Health and Clinical Nutrition, University of Eastern Finland, 70211 Kuopio, Finland.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Arner', 'Affiliation': 'Department of Medicine (H7), Karolinska Institute, 17176 Stockholm, Sweden.'}, {'ForeName': 'Matti', 'Initials': 'M', 'LastName': 'Uusitupa', 'Affiliation': 'School of Medicine, Institute of Public Health and Clinical Nutrition, University of Eastern Finland, 70211 Kuopio, Finland.'}, {'ForeName': 'Marjukka', 'Initials': 'M', 'LastName': 'Kolehmainen', 'Affiliation': 'School of Medicine, Institute of Public Health and Clinical Nutrition, University of Eastern Finland, 70211 Kuopio, Finland.'}]",Nutrients,['10.3390/nu11122932'] 804,31817691,"Differential Responses of Blood Essential Amino Acid Levels Following Ingestion of High-Quality Plant-Based Protein Blends Compared to Whey Protein-A Double-Blind Randomized, Cross-Over, Clinical Trial.","This study assessed the bio-equivalence of high-quality, plant-based protein blends versus Whey Protein Isolate (WPI) in healthy, resistance-trained men. The primary endpoint was incremental area under the curve (iAUC) of blood essential Amino Acids (eAAs) 4 hours after consumption of each product. Maximum concentration (C max ) and time to maximum concentration (T max ) of blood leucine were secondary outcomes. Subjects ( n = 18) consumed three plant-based protein blends and WPI (control). An analysis of Variance model was used to assess for bio-equivalence of total sum of blood eAA concentrations. The total blood eAA iAUC ratios of the three blends were [90% CI]: #1: 0.66 [0.58-0.76]; #2: 0.71 [0.62-0.82]; #3: 0.60 [0.52-0.69], not completely within the pre-defined equivalence range [0.80-1.25], indicative of 30-40% lower iAUC versus WPI. Leucine C max of the three blends was not equivalent to WPI, #1: 0.70 [0.67-0.73]; #2: 0.72 [0.68-0.75]; #3: 0.65 [0.62-0.68], indicative of a 28-35% lower response. Leucine T max for two blends were similar to WPI (#1: 0.94 [0.73-1.18]; #2: 1.56 [1.28-1.92]; #3: 1.19 [0.95-1.48]). The plant-based protein blends were not bio-equivalent. However, blood leucine kinetic data across the blends approximately doubled from fasting concentrations, whereas blood T max data across two blends were similar to WPI. This suggests evidence of rapid hyperleucinemia, which correlates with a protein's anabolic potential.",2019,Leucine T max for two blends were similar to WPI (#1: 0.94 [0.73-1.18]; #2: 1.56 [1.28-1.92]; #3: 1.19 [0.95-1.48]).,"['Subjects ( n = 18', 'healthy, resistance-trained men']","['high-quality, plant-based protein blends versus Whey Protein Isolate (WPI', 'consumed three plant-based protein blends and WPI (control', 'High-Quality Plant-Based Protein Blends']","['Maximum concentration (C max ) and time to maximum concentration (T max ) of blood leucine', 'Leucine C max', 'total blood eAA iAUC ratios', 'blood leucine kinetic data', 'Leucine T max', 'incremental area under the curve (iAUC) of blood essential Amino Acids (eAAs']","[{'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0032098', 'cui_str': 'Plants'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0078479', 'cui_str': 'Whey Proteins'}, {'cui': 'C0205409', 'cui_str': 'Isolated (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0005768'}, {'cui': 'C0023401', 'cui_str': 'L-leucine'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0022702', 'cui_str': 'Kinetics'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0002525', 'cui_str': 'Amino Acids, Essential'}]",,0.159385,Leucine T max for two blends were similar to WPI (#1: 0.94 [0.73-1.18]; #2: 1.56 [1.28-1.92]; #3: 1.19 [0.95-1.48]).,"[{'ForeName': 'Jessica L', 'Initials': 'JL', 'LastName': 'Brennan', 'Affiliation': 'Danone North America, Louisville, CO 80027, USA.'}, {'ForeName': 'Maneephan', 'Initials': 'M', 'LastName': 'Keerati-U-Rai', 'Affiliation': 'Danone North America, Louisville, CO 80027, USA.'}, {'ForeName': 'Huaixia', 'Initials': 'H', 'LastName': 'Yin', 'Affiliation': 'Danone North America, Louisville, CO 80027, USA.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Daoust', 'Affiliation': 'Sequel Naturals, Burnaby, BC V5G 4W3, Canada.'}, {'ForeName': 'Emilie', 'Initials': 'E', 'LastName': 'Nonnotte', 'Affiliation': 'Excelya, 92100 Boulogne-Billancourt, France.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Quinquis', 'Affiliation': 'Danone Research, 91120 Palaiseau, France.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'St-Denis', 'Affiliation': 'Danone North America, White Plains, NY 10605, USA.'}, {'ForeName': 'Douglas R', 'Initials': 'DR', 'LastName': 'Bolster', 'Affiliation': 'Danone North America, Louisville, CO 80027, USA.'}]",Nutrients,['10.3390/nu11122987'] 805,31817564,A Nutrition Education Intervention Using NOVA Is More Effective Than MyPlate Alone: A Proof-of-Concept Randomized Controlled Trial.,"The ability to classify foods based on level of processing, not only conventional MyPlate food groups, might be a useful tool for consumers faced with a wide array of highly processed food products of varying nutritional value. The objective of this study was to assess the impact of a proof-of-concept nutrition education intervention on nutrition knowledge, assessed by correct classification of foods according to MyPlate food groups, MyPlate 'limit' status (for fat, sugar, sodium), and level of processing (NOVA categories). We utilized a randomized, controlled design to examine the impact of a MyPlate vs. combined MyPlate + NOVA intervention vs. control group. Intervention groups received educational flyers via email and participants were assessed using electronic baseline and follow-up surveys. The MyPlate + NOVA intervention group performed at least as well as the MyPlate group on classifying conventional food groups and 'limit' status. Moreover, the MyPlate + NOVA group far outperformed the other groups on classifying NOVA categories. Longer-term trials are needed, but our results suggest that NOVA principles may be more easily understood and applied than those of MyPlate. Education strategies focusing on level of food processing may be effective in the context of the modern food environment.",2019,The MyPlate + NOVA intervention group performed at least as well as the MyPlate group on classifying conventional food groups and 'limit' status.,[],"['MyPlate vs. combined MyPlate + NOVA intervention', 'MyPlate + NOVA intervention', 'MyPlate + NOVA', 'concept nutrition education intervention', 'MyPlate Alone', 'educational flyers via email and participants were assessed using electronic baseline and follow-up surveys']","[""MyPlate 'limit' status (for fat, sugar, sodium), and level of processing (NOVA categories""]",[],"[{'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0204934', 'cui_str': 'Nutritional education'}, {'cui': 'C0013849', 'cui_str': 'Email'}, {'cui': 'C4281784', 'cui_str': 'Electronics'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}]","[{'cui': 'C0439801', 'cui_str': 'Limited (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0242209', 'cui_str': 'Sugars'}, {'cui': 'C3541959', 'cui_str': 'Sodium supplement (substance)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",,0.0286881,The MyPlate + NOVA intervention group performed at least as well as the MyPlate group on classifying conventional food groups and 'limit' status.,"[{'ForeName': 'Aydin', 'Initials': 'A', 'LastName': 'Nazmi', 'Affiliation': 'Food Science and Nutrition Department, California Polytechnic State University, San Luis Obispo, CA 93407, USA.'}, {'ForeName': 'Marilyn', 'Initials': 'M', 'LastName': 'Tseng', 'Affiliation': 'Kinesiology and Public Health Department, California Polytechnic State University, San Luis Obispo, CA 93407, USA.'}, {'ForeName': 'Derrick', 'Initials': 'D', 'LastName': 'Robinson', 'Affiliation': 'University of California, Division of Agriculture and Natural Resources, Davis, CA 95618, USA.'}, {'ForeName': 'Dawn', 'Initials': 'D', 'LastName': 'Neill', 'Affiliation': 'Interdisciplinary Studies in the Liberal Arts, California Polytechnic State University, San Luis Obispo, CA 93407, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Walker', 'Affiliation': 'Statistics Department, California Polytechnic State University, San Luis Obispo, CA 93407, USA.'}]",Nutrients,['10.3390/nu11122965'] 806,29667507,"Effect of inspiratory muscle training (IMT) on aerobic capacity, respiratory muscle strength and rate of perceived exertion in paraplegics.","Objectives: The purpose is to study the effect of inspiratory muscle training on aerobic capacity, respiratory muscle strength and rate of perceived exertion in paraplegics. Study Design: Randomized controlled trial. Settings: Rehabilitation department in Indian Spinal Injuries Centre, New Delhi. Participants: A sample of 30 paraplegics (T1-T12) were randomly allocated into two groups: inspiratory muscle training (IMT) group and control group. Interventions: The IMT group received inspiratory muscle training for 15 minutes 5 times a week for 4 weeks whereas the control group was given breathing exercises. Outcome measures: Maximal inspiratory pressure(MIP), maximal expiratory pressure (MEP), modified Borg's scale (MBS), 12 minute wheelchair aerobic test (12MWAT), multistage fitness test (MSFT), and 6 minutes push test (6MPT). Results: Out of 30 participants, 27 completed the study. The results show that after four weeks of IMT training, there were significant improvements in mean change scores of IMT group as compared to control group. Participants in IMT group performed better on 12MWAT (P = 0.001), MSFT (P = 0.001) and 6MPT (P = 0.001). Improvements in MIP scores (P = 0.001), MEP scores (P = 0.001) and MBS scores (P = 0.004) were also seen in IMT group. Conclusion: Both groups showed significant improvements, however inspiratory muscle training was seen to be more effective than deep breathing exercises for improving aerobic capacity, respiratory muscle strength and rate of perceived exertion in paraplegics.",2020,"Improvements in MIP scores (P = 0.001), MEP scores (P = 0.001) and MBS scores (P = 0.004) were also seen in IMT group. ","['paraplegics', 'A sample of 30 paraplegics (T1-T12', '30 participants, 27 completed the study', 'Rehabilitation department in Indian Spinal Injuries Centre, New Delhi']","['IMT', 'control group was given breathing exercises', 'deep breathing exercises', 'inspiratory muscle training (IMT', 'inspiratory muscle training (IMT) group and control group', 'inspiratory muscle training']","['MIP scores', 'aerobic capacity, respiratory muscle strength and rate of perceived exertion', 'MBS scores', 'aerobic capacity, respiratory muscle strength and rate of perceived exertion in paraplegics', 'MEP scores', 'mean change scores', ""Maximal inspiratory pressure(MIP), maximal expiratory pressure (MEP), modified Borg's scale (MBS), 12 minute wheelchair aerobic test (12MWAT), multistage fitness test (MSFT), and 6 minutes push test (6MPT"", 'MSFT']","[{'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0857021', 'cui_str': 'Paraplegic'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0587478', 'cui_str': 'Rehabilitation department (environment)'}, {'cui': 'C1524069', 'cui_str': 'Indian (racial group)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0006155', 'cui_str': 'Respiratory Muscle Training'}, {'cui': 'C0454496', 'cui_str': 'Deep breathing exercises (regime/therapy)'}, {'cui': 'C0454511', 'cui_str': 'Inspiratory muscle training (regime/therapy)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0035231', 'cui_str': 'Ventilatory Muscles'}, {'cui': 'C0015264', 'cui_str': 'Exertion, function (observable entity)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0857021', 'cui_str': 'Paraplegic'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C4083126', 'cui_str': 'Maximum Inspiratory Pressure'}, {'cui': 'C4082175', 'cui_str': 'Maximal Expiratory Pressure'}, {'cui': 'C0449399', 'cui_str': 'Borg scale (assessment scale)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0043143', 'cui_str': 'Wheel Chairs'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C1719958', 'cui_str': 'Push'}]",30.0,0.0223693,"Improvements in MIP scores (P = 0.001), MEP scores (P = 0.001) and MBS scores (P = 0.004) were also seen in IMT group. ","[{'ForeName': 'Sonali', 'Initials': 'S', 'LastName': 'Soumyashree', 'Affiliation': 'ISIC Institute of Rehabilitation Sciences, New Delhi, India.'}, {'ForeName': 'Jaskirat', 'Initials': 'J', 'LastName': 'Kaur', 'Affiliation': 'ISIC Institute of Rehabilitation Sciences, New Delhi, India.'}]",The journal of spinal cord medicine,['10.1080/10790268.2018.1462618'] 807,31810219,Apple Preload Halved the Postprandial Glycaemic Response of Rice Meal on in Healthy Subjects.,"This study aimed to investigate the possible glycemic effect of apple preload on acute postprandial glycemic responses (GRs) of a following rice meal, comparing with its co-ingestion counterpart and an apple sugar solution preload, based on equal carbohydrates intake. In a randomized crossover trial, 18 healthy female subjects consumed (1) rice, (2) co-ingestion of apple and rice (A+R), (3) apple preload and rice (PA+R), and (4) rice with sugar solution preload (same sugar profile as in apple) (PSS+R). Acute postprandial GR tests and subjective satiety tests were carried out for each test food. Compared with rice reference, the PA+R achieved a 50% reduction of the iAUC 0-120 , a 51.4% reduction of the average peak value, and a 52.6% reduction of glycemic excursion in 240 min, while the PSS+R showed 29.7% and 31.6% reduction of peak value and glycemic excursion, respectively. No significant differences were found between R and PA+R in any of the satiety characteristics. Compared with rice control, apple preload of 15 g available carbohydrates remarkably lowered the acute postprandial GR without negative effect on satiety. The sugar component may partly contribute to the glycemic suppressing effect of the apple preload.",2019,"Compared with rice reference, the PA+R achieved a 50% reduction of the iAUC 0-120 , a 51.4% reduction of the average peak value, and a 52.6% reduction of glycemic excursion in 240 min, while the PSS+R showed 29.7% and 31.6% reduction of peak value and glycemic excursion, respectively.","['18 healthy female subjects consumed (1) rice, (2', 'Healthy Subjects']","['co-ingestion of apple and rice (A+R), (3) apple preload and rice (PA+R), and (4) rice with sugar solution preload (same sugar profile as in apple', 'apple preload']","['satiety', 'acute postprandial glycemic responses (GRs', 'Postprandial Glycaemic Response of Rice Meal', 'glycemic excursion', 'peak value and glycemic excursion', 'Acute postprandial GR tests and subjective satiety tests']","[{'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0035567', 'cui_str': 'Rice'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C1095830', 'cui_str': 'Apple'}, {'cui': 'C0035567', 'cui_str': 'Rice'}, {'cui': 'C0242209', 'cui_str': 'Sugars'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}]","[{'cui': 'C0036239', 'cui_str': 'Satiations'}, {'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C0035567', 'cui_str': 'Rice'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}]",18.0,0.0128804,"Compared with rice reference, the PA+R achieved a 50% reduction of the iAUC 0-120 , a 51.4% reduction of the average peak value, and a 52.6% reduction of glycemic excursion in 240 min, while the PSS+R showed 29.7% and 31.6% reduction of peak value and glycemic excursion, respectively.","[{'ForeName': 'Jiacan', 'Initials': 'J', 'LastName': 'Lu', 'Affiliation': 'Beijing Advanced Innovation Centre for Food Nutrition and Human Health, College of Food Science and nutritional Engineering, China Agricultural University, Beijing 100083, China.'}, {'ForeName': 'Wenqi', 'Initials': 'W', 'LastName': 'Zhao', 'Affiliation': 'Beijing Advanced Innovation Centre for Food Nutrition and Human Health, College of Food Science and nutritional Engineering, China Agricultural University, Beijing 100083, China.'}, {'ForeName': 'Linlin', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Beijing Advanced Innovation Centre for Food Nutrition and Human Health, College of Food Science and nutritional Engineering, China Agricultural University, Beijing 100083, China.'}, {'ForeName': 'Zhihong', 'Initials': 'Z', 'LastName': 'Fan', 'Affiliation': 'Beijing Advanced Innovation Centre for Food Nutrition and Human Health, College of Food Science and nutritional Engineering, China Agricultural University, Beijing 100083, China.'}, {'ForeName': 'Ruixin', 'Initials': 'R', 'LastName': 'Zhu', 'Affiliation': 'Beijing Advanced Innovation Centre for Food Nutrition and Human Health, College of Food Science and nutritional Engineering, China Agricultural University, Beijing 100083, China.'}, {'ForeName': 'Yixue', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'Beijing Advanced Innovation Centre for Food Nutrition and Human Health, College of Food Science and nutritional Engineering, China Agricultural University, Beijing 100083, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'Beijing Advanced Innovation Centre for Food Nutrition and Human Health, College of Food Science and nutritional Engineering, China Agricultural University, Beijing 100083, China.'}]",Nutrients,['10.3390/nu11122912'] 808,31810342,"Effectiveness of Individual Nutrition Education Compared to Group Education, in Improving Anthropometric and Biochemical Indices among Hypertensive Adults with Excessive Body Weight: A Randomized Controlled Trial.","OBJECTIVE The study aims to compare the effectiveness of individual and group nutrition education methods in improving key anthropometric and biochemical markers in drug-treated, overweight-obese hypertensive adults. METHODS The randomized trial included 170 patients with pharmacologically well-controlled primary hypertension and body mass index (BMI) ≥ 25 kg/m 2 . For six months, the patients received six sessions, either one-to-one individual nutrition education (IE, n = 89) or group education (GE, n = 81), developed by dietitians. Anthropometric measurements, body composition, and fasting measures of biochemical parameters were obtained at baseline and after six months of intervention. RESULTS 150 patients completed the nutrition education program. The IE group significantly improved in many parameters compared to the GE group, including weight ( p < 0.001), waist circumference ( p < 0.001), BMI ( p < 0.001), systolic and diastolic blood pressure (BP) ( p < 0.001), fasting plasma glucose ( p = 0.011), oral glucose tolerance test (OGGT) ( p = 0.030), and insulin resistance (homeostatic model assessment of insulin resistance, HOMA-IR) ( p < 0.001). The groups did not differ in terms of total cholesterol, high-density lipoprotein cholesterol (HDL-C) and low-density lipoprotein cholesterol (LDL-C) concentrations. CONCLUSION Individual nutrition education is more effective than group education in terms of improving anthropometric and biochemical indices in overweight-obese hypertensive adults.",2019,"The IE group significantly improved in many parameters compared to the GE group, including weight ( p < 0.001), waist circumference ( p < 0.001), BMI ( p < 0.001), systolic and diastolic blood pressure (BP) ( p < 0.001), fasting plasma glucose ( p = 0.011), oral glucose tolerance test (OGGT) ( p = 0.030), and insulin resistance (homeostatic model assessment of insulin resistance, HOMA-IR) ( p < 0.001).","['Hypertensive Adults with Excessive Body Weight', '170 patients with pharmacologically well-controlled primary hypertension and body mass index (BMI) ≥ 25 kg/m 2 ', '150 patients completed the nutrition education program', 'drug-treated, overweight-obese hypertensive adults', 'overweight-obese hypertensive adults']","['Individual nutrition education', 'individual and group nutrition education methods', 'Individual Nutrition Education']","['insulin resistance (homeostatic model assessment of insulin resistance, HOMA-IR', 'BMI', 'weight', 'systolic and diastolic blood pressure (BP', 'fasting plasma glucose', 'total cholesterol, high-density lipoprotein cholesterol (HDL-C) and low-density lipoprotein cholesterol (LDL-C) concentrations', 'Anthropometric measurements, body composition, and fasting measures of biochemical parameters', 'waist circumference', 'oral glucose tolerance test (OGGT']","[{'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0442802', 'cui_str': 'Excessive (qualifier value)'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C4517599', 'cui_str': 'One hundred and seventy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3853142', 'cui_str': 'Well controlled'}, {'cui': 'C0085580', 'cui_str': 'Essential Hypertension'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0204934', 'cui_str': 'Nutritional education'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0204934', 'cui_str': 'Nutritional education'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}]","[{'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma (procedure)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0023822', 'cui_str': 'High Density Lipoprotein Cholesterol'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement (procedure)'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0205474', 'cui_str': 'Biochemical (qualifier value)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}]",170.0,0.0576024,"The IE group significantly improved in many parameters compared to the GE group, including weight ( p < 0.001), waist circumference ( p < 0.001), BMI ( p < 0.001), systolic and diastolic blood pressure (BP) ( p < 0.001), fasting plasma glucose ( p = 0.011), oral glucose tolerance test (OGGT) ( p = 0.030), and insulin resistance (homeostatic model assessment of insulin resistance, HOMA-IR) ( p < 0.001).","[{'ForeName': 'Danuta', 'Initials': 'D', 'LastName': 'Gajewska', 'Affiliation': 'Department of Dietetics, Faculty of Human Nutrition, Warsaw University of Life Sciences - SGGW (WULS), 159C Nowoursynowska Str, 02-776 Warsaw, Poland.'}, {'ForeName': 'Alicja', 'Initials': 'A', 'LastName': 'Kucharska', 'Affiliation': 'Human Nutrition Department, Warsaw Medical University, 02-776 Warsaw, Poland.'}, {'ForeName': 'Marcin', 'Initials': 'M', 'LastName': 'Kozak', 'Affiliation': 'Department of Botany, Warsaw University of Life Sciences - SGGW (WULS), 159C Nowoursynowska Str, 02-776 Warsaw, Poland.'}, {'ForeName': 'Shahla', 'Initials': 'S', 'LastName': 'Wunderlich', 'Affiliation': 'Department of Nutrition and Food Studies, Montclair State University, 1 Normal Avenue Montclair, Montclair, NJ 07043, USA.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Niegowska', 'Affiliation': 'Department of Dietetics, Faculty of Human Nutrition, Warsaw University of Life Sciences - SGGW (WULS), 159C Nowoursynowska Str, 02-776 Warsaw, Poland.'}]",Nutrients,['10.3390/nu11122921'] 809,31155159,Lecture-based education versus simulation in educating student nurses about central line-associated bloodstream infection-prevention guidelines.,"The Center for Disease Control and Prevention published central line-associated bloodstream infection-prevention guidelines to prevent complications and improve the quality of care; however, it is not known whether student nurses receive education about these guidelines or what is the best approach to this education. This study aimed to assess student nurses' knowledge of central line-associated bloodstream infection-prevention guidelines and to compare the effectiveness of simulation versus classroom lecturing in educating them with these prevention guidelines. It used a two-arm randomized controlled trial design with pre-post tests. It was conducted at two public universities in Jordan, with a total of 131 fourth-year student nurses as participants. The participants were randomly assigned to the experimental group (receiving classroom lectures) and the control group (receiving a simulation course). Pretest and posttest data were collected using a structured questionnaire of 23 items. The overall knowledge scores in the pretest were poor with no statistically significant difference between the two groups. In the posttest, both groups showed improvement in the majority of items. The participants in the classroom lectures group scored slightly higher in the majority of items in the posttest; however, there was no statistically significant difference in the overall scores t (129) = 1.03, P = (.57), (95% confidence interval = -1.9 to 4.3). Focusing on the elements related to clinical skills and decision-making would help to make lecture-based education an effective alternative to simulation, especially in universities and nursing schools with limited budgets.",2019,"The participants in the classroom lectures group scored slightly higher in the majority of items in the posttest; however, there was no statistically significant difference in the overall scores t (129) = 1.03, P = (.57), (95% confidence interval = -1.9 to 4.3).","['It was conducted at two public universities in Jordan, with a total of 131 fourth-year student nurses as participants']","['simulation versus classroom lecturing', 'experimental group (receiving classroom lectures', 'Lecture-based education versus simulation']",['overall knowledge scores'],"[{'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0205438', 'cui_str': 'Fourth (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0038496', 'cui_str': 'Pupil Nurses'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0376683', 'cui_str': 'Lecture'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",131.0,0.0545791,"The participants in the classroom lectures group scored slightly higher in the majority of items in the posttest; however, there was no statistically significant difference in the overall scores t (129) = 1.03, P = (.57), (95% confidence interval = -1.9 to 4.3).","[{'ForeName': 'Sami M', 'Initials': 'SM', 'LastName': 'Aloush', 'Affiliation': 'Al Al bayt University, School of Nursing, Mafraq, Jordan. Electronic address: sma91@case.edu.'}]",Journal of vascular nursing : official publication of the Society for Peripheral Vascular Nursing,['10.1016/j.jvn.2018.11.006'] 810,31751183,Right-to-left shunts in lowlanders with COPD traveling to altitude: a randomized controlled trial with dexamethasone.,"Right-to-left shunts (RLS) are prevalent in patients with chronic obstructive pulmonary disease (COPD) and might exaggerate oxygen desaturation, especially at altitude. The aim of this study was to describe the prevalence of RLS in patients with COPD traveling to altitude and the effect of preventive dexamethasone. Lowlanders with COPD [Global Initiative for Chronic Obstructive Lung Disease (GOLD) grades 1-2, oxygen saturation assessed by pulse oximetry ( S p O 2 ) >92%] were randomized to dexamethasone (4 mg bid) or placebo starting 24 h before ascent from 760 m and while staying at 3,100 m for 48 h. Saline-contrast echocardiography was performed at 760 m and after the first night at altitude. Of 87 patients (81 men, 6 women; mean ± SD age 57 ± 9 yr, forced expiratory volume in 1 s 89 ± 22% pred, S p O 2 95 ± 2%), 39 were assigned to placebo and 48 to dexamethasone. In the placebo group, 19 patients (49%) had RLS, of which 13 were intracardiac. In the dexamethasone group 23 patients (48%) had RLS, of which 11 were intracardiac ( P = 1.0 vs. dexamethasone). Eleven patients receiving placebo and 13 receiving dexamethasone developed new RLS at altitude ( P = 0.011 for both changes, P = 0.411 between groups). RLS prevalence at 3,100 m was 30 (77%) in the placebo and 36 (75%) in the dexamethasone group ( P = not significant). Development of RLS at altitude could be predicted at lowland by a higher resting pulmonary artery pressure, a lower arterial partial pressure of oxygen, and a greater oxygen desaturation during exercise but not by treatment allocation. Almost half of lowlanders with COPD revealed RLS near sea level, and this proportion significantly increased to about three-fourths when traveling to 3,100 m irrespective of dexamethasone prophylaxis. NEW & NOTEWORTHY The prevalence of intracardiac and intrapulmonary right-to-left shunts (RLS) at altitude in patients with chronic obstructive pulmonary disease (COPD) has not been studied so far. In a large cohort of patients with moderate COPD, our randomized trial showed that the prevalence of RLS increased from 48% at 760 m to 75% at 3,100 m in patients taking placebo. Preventive treatment with dexamethasone did not significantly reduce the altitude-induced recruitment of RLS. Development of RLS at 3,100 m could be predicted at 760 m by a higher resting pulmonary artery pressure and arterial partial pressure of oxygen and a more pronounced oxygen desaturation during exercise. Dexamethasone did not modify the RLS prevalence at 3,100 m.",2020,"11 patients receiving placebo and 13 dexamethasone developed new RLS at altitude (p=0.011 both changes, p=0.411 between groups).","['patients with COPD traveling to altitude', '87 patients (81 men, mean ±SD age 57 ±9 y, FEV 1 89 ±22 % pred, SpO 2 95 ±2 %) 39 were assigned to', 'Lowlanders with COPD, GOLD 1-2, oxygen saturation (SpO 2 ) >92', 'lowlanders with COPD traveling to altitude ', '11 patients receiving', 'patients with chronic obstructive pulmonary disease (COPD']","['Right-to-left shunts', 'Right-to-left shunts (RLS', 'placebo', 'dexamethasone', 'placebo, starting 24 h before ascent from 760 m and while staying at 3,100 m for 48 h. Saline contrast echocardiography']","['RLS prevalence', 'RLS near sea level', 'new RLS at altitude', 'oxygen desaturation']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C0040802', 'cui_str': 'Travel (event)'}, {'cui': 'C0002349', 'cui_str': 'Altitude'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0018026', 'cui_str': 'Gold'}, {'cui': 'C0523807', 'cui_str': 'Oximetry'}]","[{'cui': 'C0445232', 'cui_str': 'Right to left (qualifier value)'}, {'cui': 'C1442858', 'cui_str': 'Surgical fistula'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0013518', 'cui_str': 'Echocardiography, Contrast'}]","[{'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0475806', 'cui_str': 'Nr - Near'}, {'cui': 'C0036493', 'cui_str': 'Sea (environment)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0002349', 'cui_str': 'Altitude'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}]",81.0,0.576509,"11 patients receiving placebo and 13 dexamethasone developed new RLS at altitude (p=0.011 both changes, p=0.411 between groups).","[{'ForeName': 'Mona', 'Initials': 'M', 'LastName': 'Lichtblau', 'Affiliation': 'Pulmonary Division and Sleep Disorders Center, University Hospital of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Furian', 'Affiliation': 'Pulmonary Division and Sleep Disorders Center, University Hospital of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Sayaka S', 'Initials': 'SS', 'LastName': 'Aeschbacher', 'Affiliation': 'Pulmonary Division and Sleep Disorders Center, University Hospital of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Maya', 'Initials': 'M', 'LastName': 'Bisang', 'Affiliation': 'Pulmonary Division and Sleep Disorders Center, University Hospital of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Ulan', 'Initials': 'U', 'LastName': 'Sheraliev', 'Affiliation': 'National Center for Cardiology and Internal Medicine, Bishkek, Kyrgyzstan.'}, {'ForeName': 'Maamed', 'Initials': 'M', 'LastName': 'Mademilov', 'Affiliation': 'National Center for Cardiology and Internal Medicine, Bishkek, Kyrgyzstan.'}, {'ForeName': 'Nuriddin H', 'Initials': 'NH', 'LastName': 'Marazhapov', 'Affiliation': 'National Center for Cardiology and Internal Medicine, Bishkek, Kyrgyzstan.'}, {'ForeName': 'Stefanie', 'Initials': 'S', 'LastName': 'Ulrich', 'Affiliation': 'Pulmonary Division and Sleep Disorders Center, University Hospital of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Talant', 'Initials': 'T', 'LastName': 'Sooronbaev', 'Affiliation': 'National Center for Cardiology and Internal Medicine, Bishkek, Kyrgyzstan.'}, {'ForeName': 'Konrad E', 'Initials': 'KE', 'LastName': 'Bloch', 'Affiliation': 'Pulmonary Division and Sleep Disorders Center, University Hospital of Zurich, Zurich, Switzerland.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Ulrich', 'Affiliation': 'Pulmonary Division and Sleep Disorders Center, University Hospital of Zurich, Zurich, Switzerland.'}]","Journal of applied physiology (Bethesda, Md. : 1985)",['10.1152/japplphysiol.00548.2019'] 811,31930060,Comparison of a novel handheld accelerometer-based navigation system and conventional instrument for performing distal femoral resection in total knee arthroplasty: a randomized controlled trial.,"Background This prospective study aimed to compare the efficacy of a novel, hand-held, accelerometer-based navigation system (i-JOIN knee navigation system) for distal femoral resection in total knee arthroplasty (TKA) with conventional instrument. Methods A multi-center, double-blinded, randomized controlled trial (RCT) was conducted. A total of 79 consecutive patients scheduled for primary TKA were enrolled and divided into navigation group (39 patients) and conventional group (40 patients). Post-operative mechanical and component position were evaluated through full-leg weight bearing X-ray. Pre-operatively and 1 week post-operatively, adverse events were recorded. Intraoperative surgical time and blood loss were also recorded. Results The mean outlier of 180° neutral mechanical axis was 1.60° (SD 1.11°) in navigation group and 2.30° (SD 2.06°) in conventional group (P=0.0917). Thirty-eight patients (97.4%) in navigation group and 35 patients (87.5%) in conventional group had an alignment which was ≤3°away from the neutral mechanical axis (P=0.2007). α angle between the navigation group and conventional group was not statistically different (89.81° vs. 89.76°, P>0.05), as well as adverse events rate post-operatively. The operative time of navigation group was significantly longer than that of control group (114.54±35.34 vs. 100.33±28.38 min, P=0.0493), whereas the intraoperative blood loss was not significantly different. Conclusions i-JOIN knee navigation system had equivalent results for distal femoral resection in TKA compared with the conventional technique.",2019,"The operative time of navigation group was significantly longer than that of control group (114.54±35.34 vs. 100.33±28.38 min, P=0.0493), whereas the intraoperative blood loss was not significantly different. ","['total knee arthroplasty', '79 consecutive patients scheduled for primary TKA were enrolled and divided into navigation group (39 patients) and conventional group (40 patients', 'distal femoral resection in total knee arthroplasty (TKA']","['novel handheld accelerometer-based navigation system and conventional instrument', 'novel, hand-held, accelerometer-based navigation system (i-JOIN knee navigation system']","['intraoperative blood loss', 'Intraoperative surgical time and blood loss', 'operative time', 'mean outlier of 180° neutral mechanical axis', 'distal femoral resection']","[{'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}, {'cui': 'C0030703', 'cui_str': 'Schedules, Patient'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0205108', 'cui_str': 'Distal (qualifier value)'}, {'cui': 'C0015811', 'cui_str': 'Femur'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}]","[{'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C4075648', 'cui_str': 'Navigation system'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C4551823', 'cui_str': 'instruments'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C1553387', 'cui_str': 'Hold'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}]","[{'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0443254', 'cui_str': 'Mechanical (qualifier value)'}, {'cui': 'C0004457', 'cui_str': 'C2 Vertebra'}, {'cui': 'C0205108', 'cui_str': 'Distal (qualifier value)'}, {'cui': 'C0015811', 'cui_str': 'Femur'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}]",79.0,0.0885317,"The operative time of navigation group was significantly longer than that of control group (114.54±35.34 vs. 100.33±28.38 min, P=0.0493), whereas the intraoperative blood loss was not significantly different. ","[{'ForeName': 'Xingquan', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': 'State Key Laboratory of Pharmaceutical Biotechnology, Department of Sports Medicine and Adult Reconstructive Surgery, Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School, Nanjing 210008, China.'}, {'ForeName': 'Peilai', 'Initials': 'P', 'LastName': 'Liu', 'Affiliation': 'Qilu Hospital of Shandong University, Jinan 250012, China.'}, {'ForeName': 'Zhenfeng', 'Initials': 'Z', 'LastName': 'Yuan', 'Affiliation': ""Liaocheng People's Hospital, Liaocheng 252000, China.""}, {'ForeName': 'Dawei', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': ""Liaocheng People's Hospital, Liaocheng 252000, China.""}, {'ForeName': 'Qunshan', 'Initials': 'Q', 'LastName': 'Lu', 'Affiliation': 'Qilu Hospital of Shandong University, Jinan 250012, China.'}, {'ForeName': 'Zhe', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'State Key Laboratory of Pharmaceutical Biotechnology, Department of Sports Medicine and Adult Reconstructive Surgery, Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School, Nanjing 210008, China.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Jiang', 'Affiliation': 'State Key Laboratory of Pharmaceutical Biotechnology, Department of Sports Medicine and Adult Reconstructive Surgery, Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School, Nanjing 210008, China.'}, {'ForeName': 'Dongquan', 'Initials': 'D', 'LastName': 'Shi', 'Affiliation': 'State Key Laboratory of Pharmaceutical Biotechnology, Department of Sports Medicine and Adult Reconstructive Surgery, Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School, Nanjing 210008, China.'}]",Annals of translational medicine,['10.21037/atm.2019.10.55'] 812,31757794,Effects of Pioglitazone on Glucose-Dependent Insulinotropic Polypeptide-Mediated Insulin Secretion and Adipocyte Receptor Expression in Patients With Type 2 Diabetes.,"Incretin hormone dysregulation contributes to reduced insulin secretion and hyperglycemia in patients with type 2 diabetes mellitus (T2DM). Resistance to glucose-dependent insulinotropic polypeptide (GIP) action may occur through desensitization or downregulation of β-cell GIP receptors (GIP-R). Studies in rodents and cell lines show GIP-R expression can be regulated through peroxisome proliferator-activated receptor γ (PPARγ) response elements (PPREs). Whether this occurs in humans is unknown. To test this, we conducted a randomized, double-blind, placebo-controlled trial of pioglitazone therapy on GIP-mediated insulin secretion and adipocyte GIP-R expression in subjects with well-controlled T2DM. Insulin sensitivity improved, but the insulinotropic effect of infused GIP was unchanged following 12 weeks of pioglitazone treatment. In parallel, we observed increased GIP-R mRNA expression in subcutaneous abdominal adipocytes from subjects treated with pioglitazone. Treatment of cultured human adipocytes with troglitazone increased PPARγ binding to GIP-R PPREs. These results show PPARγ agonists regulate GIP-R expression through PPREs in human adipocytes, but suggest this mechanism is not important for regulation of the insulinotropic effect of GIP in subjects with T2DM. Because GIP has antilipolytic and lipogenic effects in adipocytes, the increased GIP-R expression may mediate accretion of fat in patients with T2DM treated with PPARγ agonists.",2020,"Insulin sensitivity improved, but the insulinotropic effect of infused GIP was unchanged following 12 weeks of pioglitazone treatment.","['subjects with T2DM', 'patients with T2DM treated with PPARγ agonists', 'patients with Type 2 Diabetes Mellitus (T2DM', 'Patients with Type 2 Diabetes', 'subjects with well controlled T2DM']","['placebo', 'troglitazone', 'pioglitazone', 'Pioglitazone']","['GIP-R mRNA expression', 'Insulin sensitivity', 'insulin secretion and hyperglycemia', 'GIP-mediated insulin secretion and adipocyte GIP-R expression', 'insulinotropic effect of infused GIP']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C3853142', 'cui_str': 'Well controlled'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0245514', 'cui_str': 'troglitazone'}, {'cui': 'C0071097', 'cui_str': 'pioglitazone'}]","[{'cui': 'C1702020', 'cui_str': '37-epsilon-palmitoyl-Lys-GIP'}, {'cui': 'C0035696', 'cui_str': 'mRNA'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C1256369', 'cui_str': 'Insulin Secretion'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}, {'cui': 'C0206131', 'cui_str': 'Fat Cells'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C4707055', 'cui_str': 'Infuse'}]",,0.0635476,"Insulin sensitivity improved, but the insulinotropic effect of infused GIP was unchanged following 12 weeks of pioglitazone treatment.","[{'ForeName': 'William G', 'Initials': 'WG', 'LastName': 'Tharp', 'Affiliation': 'Department of Anesthesiology, University of Vermont Medical Center, Larner College of Medicine, University of Vermont, Burlington, VT.'}, {'ForeName': 'Dhananjay', 'Initials': 'D', 'LastName': 'Gupta', 'Affiliation': 'Division of Endocrinology, Diabetes, and Metabolism, Department of Medicine, Larner College of Medicine, University of Vermont, Burlington, VT.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Sideleva', 'Affiliation': 'Division of Endocrinology, Diabetes, and Metabolism, Department of Medicine, Larner College of Medicine, University of Vermont, Burlington, VT.'}, {'ForeName': 'Carolyn F', 'Initials': 'CF', 'LastName': 'Deacon', 'Affiliation': 'Department of Biomedical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Jens J', 'Initials': 'JJ', 'LastName': 'Holst', 'Affiliation': 'Cardiovascular Division, Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Dariush', 'Initials': 'D', 'LastName': 'Elahi', 'Affiliation': 'Cardiovascular Division, Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Richard E', 'Initials': 'RE', 'LastName': 'Pratley', 'Affiliation': 'AdventHealth Translational Research Institute for Metabolism and Diabetes, Orlando, FL richard.pratley@flhosp.org.'}]",Diabetes,['10.2337/db18-1163'] 813,31651246,Comparative study between intrathecal dexmedetomidine and intrathecal magnesium sulfate for the prevention of post-spinal anaesthesia shivering in uroscopic surgery; (RCT).,"BACKGROUND Hypothermia and shivering are common complications after spinal anaesthesia, especially after uroscopic procedures in which large amounts of cold intraluminal irrigation fluids are used. Magnesium sulfate and dexmedetomidine are the most effective adjuvants with the least side effects. The aim of this study was to compare the effects of intrathecal dexmedetomidine versus intrathecal magnesium sulfate on the prevention of post-spinal anaesthesia shivering. METHODS This prospective randomized, double-blinded controlled study included 105 patients who were scheduled for uroscopic surgery at the Kasr El-Aini Hospital. The patients were randomly allocated into three groups. Group C (n = 35) received 2.5 ml of hyperbaric bupivacaine 0.5% (12.5 mg) + 0.5 ml of normal saline, Group M (n = 35) received 2.5 ml of hyperbaric bupivacaine 0.5% (12.5 mg) + 25 mg of magnesium sulfate in 0.5 ml saline, and Group D (n = 35) received 2.5 ml of hyperbaric bupivacaine 0.5% (12.5 mg) + 5 μg of dexmedetomidine in 0.5 ml saline. The primary outcomes were the incidence and intensity of shivering. The secondary outcomes were the incidence of hypothermia, sedation, the use of meperidine to control shivering and complications. RESULTS Group C had significantly higher proportions of patients who developed shivering (21), developed grade IV shivering (20) and required meperidine (21) to treat shivering than group M (8,5,5) and group D (5,3,6), which were comparable to each other. The time between block administration and meperidine administration was similar among the three groups. Hypothermia did not occur in any of the patients. The three groups were comparable regarding the occurrence of nausea, vomiting, bradycardia and hypotension. All the patients in group C, 32 patients in group M and 33 patients in group D had a sedation score of 2. Three patients in group M and 2 patients in group D had a sedation score of 3. CONCLUSIONS Intrathecal injections of both dexmedetomidine and magnesium sulfate were effective in reducing the incidence of post-spinal anaesthesia shivering. Therefore, we encourage the use of magnesium sulfate, as it is more physiologically available, more readily available in most operating theatres and much less expensive than dexmedetomidine. TRIAL REGISTRATION Clinical trial registration ID: Pan African Clinical Trial Registry (PACTR) Trial Number PACTR201801003001727 ; January 2018, ""retrospectively registered"".",2019,"RESULTS Group C had significantly higher proportions of patients who developed shivering (21), developed grade IV shivering (20) and required meperidine (21) to treat shivering than group M (8,5,5) and group D (5,3,6), which were comparable to each other.","['105 patients who were scheduled for uroscopic surgery at the Kasr El-Aini Hospital', 'post-spinal anaesthesia shivering in uroscopic surgery']","['intrathecal dexmedetomidine', 'dexmedetomidine and magnesium sulfate', 'hyperbaric bupivacaine 0.5% (12.5\u2009mg)\u2009+\u20090.5\u2009ml of normal saline, Group M (n\xa0=\u200935) received 2.5\u2009ml of hyperbaric bupivacaine 0.5% (12.5\u2009mg)\u2009+\u200925\u2009mg of magnesium sulfate in 0.5', 'Magnesium sulfate and dexmedetomidine', 'meperidine', 'magnesium sulfate', 'ml saline', 'hyperbaric bupivacaine 0.5% (12.5\u2009mg)\u2009+\u20095\u2009μg of dexmedetomidine in 0.5', 'intrathecal dexmedetomidine and intrathecal magnesium sulfate', 'intrathecal magnesium sulfate']","['incidence of post-spinal anaesthesia shivering', 'sedation score of 3', 'sedation score', 'incidence of hypothermia, sedation, the use of meperidine to control shivering and complications', 'grade IV shivering', 'occurrence of nausea, vomiting, bradycardia and hypotension', 'Hypothermia', 'incidence and intensity of shivering']","[{'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0002928', 'cui_str': 'Spinal Anesthesia'}, {'cui': 'C0036973', 'cui_str': 'Shiverings'}]","[{'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0024480', 'cui_str': 'Magnesium Sulfate'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C4517544', 'cui_str': '12.5 (qualifier value)'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C0441847', 'cui_str': 'Group M (qualifier value)'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0025376', 'cui_str': 'pethidine'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0002928', 'cui_str': 'Spinal Anesthesia'}, {'cui': 'C0036973', 'cui_str': 'Shiverings'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0413252', 'cui_str': 'Hypothermia due to exposure'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0025376', 'cui_str': 'pethidine'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0428977', 'cui_str': 'Bradyarrhythmia'}, {'cui': 'C0020649', 'cui_str': 'Blood Pressure, Low'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}]",105.0,0.175835,"RESULTS Group C had significantly higher proportions of patients who developed shivering (21), developed grade IV shivering (20) and required meperidine (21) to treat shivering than group M (8,5,5) and group D (5,3,6), which were comparable to each other.","[{'ForeName': 'Heba', 'Initials': 'H', 'LastName': 'Omar', 'Affiliation': 'Anesthesia Department, Faculty of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Wessam Adel', 'Initials': 'WA', 'LastName': 'Aboella', 'Affiliation': 'El Sahel Teaching Hospital, Cairo, Egypt.'}, {'ForeName': 'Mohammed Mahmoud', 'Initials': 'MM', 'LastName': 'Hassan', 'Affiliation': 'Anesthesia Department, National Cancer Institute, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Amany', 'Initials': 'A', 'LastName': 'Hassan', 'Affiliation': 'Anesthesia Department, Faculty of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Passaint', 'Initials': 'P', 'LastName': 'Hassan', 'Affiliation': 'Anesthesia Department, Faculty of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Elshall', 'Affiliation': 'Anesthesia Department, Faculty of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Dalia', 'Initials': 'D', 'LastName': 'Khaled', 'Affiliation': 'Anesthesia Department, Faculty of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Maha', 'Initials': 'M', 'LastName': 'Mostafa', 'Affiliation': 'Anesthesia Department, Faculty of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Pierre Zarif', 'Initials': 'PZ', 'LastName': 'Tawadros', 'Affiliation': 'Anesthesia Department, Faculty of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Mona', 'Initials': 'M', 'LastName': 'Hossam Eldin', 'Affiliation': 'Anesthesia Department, Faculty of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Mai', 'Initials': 'M', 'LastName': 'Wedad', 'Affiliation': 'Anesthesia Department, Faculty of Medicine, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Bassant Mohamed', 'Initials': 'BM', 'LastName': 'Abdelhamid', 'Affiliation': 'Anesthesia Department, Faculty of Medicine, Cairo University, Cairo, Egypt. bassantmohamed197@yahoo.com.'}]",BMC anesthesiology,['10.1186/s12871-019-0853-0'] 814,31656179,Shaping anesthetic techniques to reduce post-operative delirium (SHARP) study: a protocol for a prospective pragmatic randomized controlled trial to evaluate spinal anesthesia with targeted sedation compared with general anesthesia in older adults undergoing lumbar spine fusion surgery.,"BACKGROUND Postoperative delirium is common in older adults, especially in those patients undergoing spine surgery, in whom it is estimated to occur in > 30% of patients. Although previously thought to be transient, it is now recognized that delirium is associated with both short- and long-term complications. Optimizing the depth of anesthesia may represent a modifiable strategy for delirium prevention. However, previous studies have generally not focused on reducing the depth of anesthesia beyond levels consistent with general anesthesia. Additionally, the results of prior studies have been conflicting. The primary aim of this study is to determine whether reduced depth of anesthesia using spinal anesthesia reduces the incidence of delirium after lumbar fusion surgery compared with general anesthesia. METHODS This single-center randomized controlled trial is enrolling 218 older adults undergoing lumbar fusion surgery. Patients are randomized to reduced depth of anesthesia in the context of spinal anesthesia with targeted sedation using processed electroencephalogram monitoring versus general anesthesia without processed electroencephalogram monitoring. All patients are evaluated for delirium using the Confusion Assessment Method for 3 days after surgery or until discharge and undergo assessments of cognition, function, health-related quality of life, and pain at 3- and 12-months after surgery. The primary outcome is any occurrence of delirium. The main secondary outcome is change in the Mini-Mental Status Examination (or telephone equivalent) at 3-months after surgery. DISCUSSION Delirium is an important complication after surgery in older adults. The results of this study will examine whether reduced depth of anesthesia using spinal anesthesia with targeted depth of sedation represents a modifiable intervention to reduce the incidence of delirium and other long-term outcomes. The results of this study will be presented at national meetings and published in peer-reviewed journals with the goal of improving perioperative outcomes for older adults. TRIAL REGISTRATION Clinicaltrials.gov , NCT03133845. This study was submitted to Clinicaltrials.gov on October 23, 2015; however, it was not formally registered until April 28, 2017 due to formatting requirements from the registry, so the formal registration is retrospective.",2019,"The main secondary outcome is change in the Mini-Mental Status Examination (or telephone equivalent) at 3-months after surgery. ","['218 older adults undergoing lumbar fusion surgery', 'October 23, 2015; however, it was not formally registered until April 28, 2017 due to formatting requirements from the registry, so the formal registration is retrospective', 'older adults', 'older adults undergoing lumbar spine fusion surgery']","['spinal anesthesia with targeted sedation using processed electroencephalogram monitoring versus general anesthesia without processed electroencephalogram monitoring', 'spinal anesthesia', 'general anesthesia', 'spinal anesthesia with targeted sedation']","['occurrence of delirium', 'change in the Mini-Mental Status Examination (or telephone equivalent', 'cognition, function, health-related quality of life, and pain']","[{'cui': 'C4517647', 'cui_str': 'Two hundred and eighteen'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0024090', 'cui_str': 'Lumbar Region'}, {'cui': 'C1293131', 'cui_str': 'Fusion procedure (procedure)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C1720302', 'cui_str': 'Until'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C3887615', 'cui_str': 'Lumbar spine structure (body structure)'}]","[{'cui': 'C0002928', 'cui_str': 'Spinal Anesthesia'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C4521054', 'cui_str': 'Process (qualifier value)'}, {'cui': 'C1527380', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0002915', 'cui_str': 'General Anesthesia'}]","[{'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0451306', 'cui_str': 'Folstein Mini-Mental State Examination'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",218.0,0.269225,"The main secondary outcome is change in the Mini-Mental Status Examination (or telephone equivalent) at 3-months after surgery. ","[{'ForeName': 'Charles H', 'Initials': 'CH', 'LastName': 'Brown', 'Affiliation': 'Department of Anesthesiology & Critical Care Medicine, Johns Hopkins University School of Medicine, Zayed 6208, 1800 Orleans St, Baltimore, MD, 21287, USA. cbrownv@jhmi.edu.'}, {'ForeName': 'Emily L', 'Initials': 'EL', 'LastName': 'Jones', 'Affiliation': 'Department of Anesthesiology & Critical Care Medicine, Johns Hopkins University School of Medicine, Zayed 6208, 1800 Orleans St, Baltimore, MD, 21287, USA.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Lin', 'Affiliation': 'Mercy Anesthesiology Associates, 300 St. Paul Place, Baltimore, MD, 21202, USA.'}, {'ForeName': 'Melody', 'Initials': 'M', 'LastName': 'Esmaili', 'Affiliation': 'Mercy Anesthesiology Associates, 300 St. Paul Place, Baltimore, MD, 21202, USA.'}, {'ForeName': 'Yara', 'Initials': 'Y', 'LastName': 'Gorashi', 'Affiliation': 'Tufts University School of Medicine, 145 Harrison Ave, Boston, MA, 02111, USA.'}, {'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Skelton', 'Affiliation': 'University of Miami Miller School of Medicine, 1600 NW 10th avenue, Miami, FL, 33136, USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Kaganov', 'Affiliation': 'Department of Anesthesiology & Critical Care Medicine, Johns Hopkins University School of Medicine, Zayed 6208, 1800 Orleans St, Baltimore, MD, 21287, USA.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Colantuoni', 'Affiliation': 'Department of Biostatistics, Johns Hopkins Bloomberg School of Public Health, 615 N. Wolfe St, Baltimore, MD, 21287, USA.'}, {'ForeName': 'Lisa R', 'Initials': 'LR', 'LastName': 'Yanek', 'Affiliation': 'Department of Medicine, Johns Hopkins University School of Medicine, 1830 Building; 8024, 600 N. Wolfe St, Baltimore, MD, 21287, USA.'}, {'ForeName': 'Karin J', 'Initials': 'KJ', 'LastName': 'Neufeld', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, A4 Center Suite 457, 4940 Eastern Avenue, Baltimore, MD, 21224, USA.'}, {'ForeName': 'Vidyulata', 'Initials': 'V', 'LastName': 'Kamath', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, A4 Center Suite 457, 4940 Eastern Avenue, Baltimore, MD, 21224, USA.'}, {'ForeName': 'Frederick E', 'Initials': 'FE', 'LastName': 'Sieber', 'Affiliation': 'Department of Anesthesiology & Critical Care Medicine, Johns Hopkins University School of Medicine, Zayed 6208, 1800 Orleans St, Baltimore, MD, 21287, USA.'}, {'ForeName': 'Clayton L', 'Initials': 'CL', 'LastName': 'Dean', 'Affiliation': 'The Maryland Spine Center at Mercy, 301 St. Paul Place, Baltimore, MD, 21202, USA.'}, {'ForeName': 'Charles C', 'Initials': 'CC', 'LastName': 'Edwards', 'Affiliation': 'The Maryland Spine Center at Mercy, 301 St. Paul Place, Baltimore, MD, 21202, USA.'}, {'ForeName': 'Charles W', 'Initials': 'CW', 'LastName': 'Hogue', 'Affiliation': 'Department of Anesthesiology, Northwestern Feinberg School of Medicine, NMH/Feinberg Room 5-704, 251 E Huron, Northwestern Feinberg School of Medicine, Chicago, IL, 60611, USA.'}]",BMC anesthesiology,['10.1186/s12871-019-0867-7'] 815,31952916,Benefits of vestibular rehabilitation on patient-reported outcomes in older adults with vestibular disorders: a randomized clinical trial.,"BACKGROUND Chronic dizziness has a negative impact on emotional aspects, functional capacity, and quality of life of older people. OBJECTIVE To compare the effects of the conventional Cawthorne & Cooksey and the multimodal Cawthorne & Cooksey protocols on patient-reported outcomes in older adults with vestibular disorders. METHODS This is a single-blind, randomized controlled trial with three-months' follow-up. Older adults with chronic dizziness were randomly assigned to conventional or multimodal protocols. The protocols were performed in individual 50-minute sessions, twice weekly, for two months. The primary outcome was the Dizziness Handicap Inventory (DHI) and the secondary outcomes were the Visual Analogue Scale, the Vestibular Disorders Activities of Daily Living Scale, the Geriatric Depression Scale, and the Activities-specific Balance Confidence Scale. Outcomes were collected at baseline, post-treatment and three-month follow-up; and analyzed on an intention-to-treat approach. RESULTS Eighty-two patients were randomized into the conventional (n = 40) or multimodal (n = 42) protocols. There was no between-group difference on DHI at post-treatment (Mean Difference (MD): -0.7 95%CI: -9.2, 7.8) and at three-month follow-up (MD: -1.6 95%CI: -9.5, 6.2). No between-group difference was found for the secondary outcomes. All patient-reported outcomes in the within-group analysis showed significant improvement between baseline and post-treatment, and changes were maintained between post-treatment and follow-up. Following treatment, 55% of patients in the conventional and 57% in the multimodal protocol reached DHI clinical improvement (decrease ≥18). CONCLUSIONS The addition of multimodal exercises to the conventional Cawthorne & Cooksey protocol did not promote extra benefits on patient-reported outcomes in older adults with chronic dizziness. TRIAL REGISTRATION Australian New Zealand Clinical Trials Registry-ANZCTR (ACTRN12610000018011), the trial was registered January 7, 2010 and the first participant was enrolled April 15, 2010. URL of the registry: https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=334985.",2020,"The addition of multimodal exercises to the conventional Cawthorne & Cooksey protocol did not promote extra benefits on patient-reported outcomes in older adults with chronic dizziness. ","['older adults with chronic dizziness', 'Eighty-two patients were randomized into the conventional (n = 40) or multimodal (n = 42) protocols', 'older adults with vestibular disorders', '0.7 95%CI', 'Older adults with chronic dizziness', 'trial was registered January 7, 2010 and the first participant was enrolled April 15, 2010']","['vestibular rehabilitation', 'conventional Cawthorne & Cooksey and the multimodal Cawthorne & Cooksey protocols', 'conventional or multimodal protocols', '95%CI']","['Visual Analogue Scale, the Vestibular Disorders Activities of Daily Living Scale, the Geriatric Depression Scale, and the Activities-specific Balance Confidence Scale', 'Dizziness Handicap Inventory (DHI', 'DHI', 'DHI clinical improvement']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C2609434', 'cui_str': 'Vestibular disorders (SMQ)'}, {'cui': 'C4517474', 'cui_str': '0.7 (qualifier value)'}, {'cui': 'C0600375', 'cui_str': 'Registers'}]","[{'cui': 'C0200324', 'cui_str': 'Vestibular rehabilitation'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}]","[{'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C2609434', 'cui_str': 'Vestibular disorders (SMQ)'}, {'cui': 'C0001288', 'cui_str': 'ADL'}, {'cui': 'C0222045'}, {'cui': 'C0451184', 'cui_str': 'Geriatric depression scale (assessment scale)'}, {'cui': 'C2733457', 'cui_str': 'ABC (activities-specific balance confidence) scale'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0018576', 'cui_str': 'Handicapped'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}]",82.0,0.137794,"The addition of multimodal exercises to the conventional Cawthorne & Cooksey protocol did not promote extra benefits on patient-reported outcomes in older adults with chronic dizziness. ","[{'ForeName': 'Mayra Cristina', 'Initials': 'MC', 'LastName': 'Aratani', 'Affiliation': 'Department of Otorhinolaryngology and Head & Neck Surgery, Otoneurology Discipline, Universidade Federal de São Paulo (UNIFESP), São Paulo, Brazil.'}, {'ForeName': 'Natalia Aquaroni', 'Initials': 'NA', 'LastName': 'Ricci', 'Affiliation': ""Department of Otorhinolaryngology and Head & Neck Surgery, Otoneurology Discipline, Universidade Federal de São Paulo (UNIFESP), São Paulo, Brazil; Master's and Doctoral Programs in Physical Therapy, Universidade Cidade de São Paulo (UNICID), São Paulo, Brazil. Electronic address: natalia_ricci@hotmail.com.""}, {'ForeName': 'Heloísa Helena', 'Initials': 'HH', 'LastName': 'Caovilla', 'Affiliation': 'Department of Otorhinolaryngology and Head & Neck Surgery, Otoneurology Discipline, Universidade Federal de São Paulo (UNIFESP), São Paulo, Brazil.'}, {'ForeName': 'Fernando Freitas', 'Initials': 'FF', 'LastName': 'Ganança', 'Affiliation': 'Department of Otorhinolaryngology and Head & Neck Surgery, Otoneurology Discipline, Universidade Federal de São Paulo (UNIFESP), São Paulo, Brazil.'}]",Brazilian journal of physical therapy,['10.1016/j.bjpt.2019.12.003'] 816,31950307,The Influence of Relationship Dynamics and Sexual Agreements on Perceived Partner Support and Benefit of PrEP Use Among Same-Sex Male Couples in the U.S.,"Use of Pre-exposure prophylaxis (PrEP) for HIV prevention by men who have sex with men (MSM) may be impacted by relationship dynamics. We assessed perceived partner support of PrEP use and benefit of PrEP by relationship characteristics among male couples. Baseline data from a randomized control trial of video-based HIV counseling and testing among male couples in the U.S. were used in adjusted multilevel regression models to assess individual and dyadic characteristics. Among 659 participants, 73.3% thought their partner would be supportive of their PrEP use; 26.7% reported their partner would not support PrEP use, which was significantly associated with intimate partner violence (IPV) (p = 0.008). Most (57.7%) did not believe PrEP would be beneficial to them or their partner. Couples with a sexual agreement allowing outside partners were significantly associated with higher perceived support of partners for PrEP (p < 0.001) and benefit of PrEP use (p < 0.001). Perceived partner support of PrEP was high but perceived benefit of PrEP was low, both shaped by relationship dynamics that highlight the need for tailored dyadic interventions. The association between perceived PrEP support and IPV points to the need to integrate relationship contexts in HIV prevention programs.",2020,Couples with a sexual agreement allowing outside partners were significantly associated with higher perceived support of partners for PrEP (p < 0.001) and benefit of PrEP use (p < 0.001).,"['male couples in the U.S', 'male couples', 'Same-Sex Male Couples in the U.S', 'men who have sex with men (MSM']","['video-based HIV counseling', 'Pre-exposure prophylaxis (PrEP', 'PrEP']",['intimate partner violence (IPV'],"[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}]","[{'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0730426', 'cui_str': 'Human immunodeficiency virus counseling'}, {'cui': 'C3850098', 'cui_str': 'Pre-Exposure Prophylaxis (PrEP)'}]","[{'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}, {'cui': 'C0276240', 'cui_str': 'Infectious pustular vulvovaginitis (disorder)'}]",659.0,0.0471386,Couples with a sexual agreement allowing outside partners were significantly associated with higher perceived support of partners for PrEP (p < 0.001) and benefit of PrEP use (p < 0.001).,"[{'ForeName': 'Erin M', 'Initials': 'EM', 'LastName': 'Kahle', 'Affiliation': 'Center for Sexuality and Health Disparities, School of Nursing, University of Michigan, Ann Arbor, USA. ekahle@umich.edu.'}, {'ForeName': 'Akshay', 'Initials': 'A', 'LastName': 'Sharma', 'Affiliation': 'Center for Sexuality and Health Disparities, School of Nursing, University of Michigan, Ann Arbor, USA.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Sullivan', 'Affiliation': 'Center for Sexuality and Health Disparities, School of Nursing, University of Michigan, Ann Arbor, USA.'}, {'ForeName': 'Rob', 'Initials': 'R', 'LastName': 'Stephenson', 'Affiliation': 'Center for Sexuality and Health Disparities, School of Nursing, University of Michigan, Ann Arbor, USA.'}]",AIDS and behavior,['10.1007/s10461-020-02782-9'] 817,31708182,"Safety and immunogenicity of the RTS,S/AS01 malaria vaccine in infants and children identified as HIV-infected during a randomized trial in sub-Saharan Africa.","BACKGROUND We assessed the safety and immunogenicity of the RTS,S/AS01 malaria vaccine in a subset of children identified as HIV-infected during a large phase III randomized controlled trial conducted in seven sub-Saharan African countries. METHODS Infants 6-12 weeks and children 5-17 months old were randomized to receive 4 RTS,S/AS01 doses (R3R group), 3 RTS,S/AS01 doses plus 1 comparator vaccine dose (R3C group), or 4 comparator vaccine doses (C3C group) at study months 0, 1, 2 and 20. Infants and children with WHO stage III/IV HIV disease were excluded but HIV testing was not routinely performed on all participants; our analyses included children identified as HIV-infected based on medical history or clinical suspicion and confirmed by polymerase chain reaction or antibody testing. Serious adverse events (SAEs) and anti-circumsporozoite (CS) antibodies were assessed. RESULTS Of 15459 children enrolled in the trial, at least 1953 were tested for HIV and 153 were confirmed as HIV-infected (R3R: 51; R3C: 54; C3C: 48). Among these children, SAEs were reported for 92.2% (95% CI: 81.1-97.8) in the R3R, 85.2% (72.9-93.4) in the R3C and 87.5% (74.8-95.3) in the C3C group over a median follow-up of 39.3, 39.4 and 38.3 months, respectively. Fifteen HIV-infected participants in each group (R3R: 29.4%, R3C: 27.8%, C3C: 31.3%) died during the study. No deaths were considered vaccination-related. In a matched case-control analysis, 1 month post dose 3 anti-CS geometric mean antibody concentrations were 193.3 EU/mL in RTS,S/AS01-vaccinated HIV-infected children and 491.5 EU/mL in RTS,S/AS01-vaccinated immunogenicity controls with unknown or negative HIV status (p = 0.0001). CONCLUSIONS The safety profile of RTS,S/AS01 in HIV-infected children was comparable to that of the comparator (meningococcal or rabies) vaccines. RTS,S/AS01 was immunogenic in HIV-infected children but antibody concentrations were lower than in children with an unknown or negative HIV status. CLINICAL TRIAL REGISTRATION ClinicalTrials.gov: NCT00866619.",2020,"RTS,S/AS01 was immunogenic in HIV-infected children but antibody concentrations were lower than in children with an unknown or negative HIV status. ","['Infants and children with WHO stage III/IV HIV disease were excluded but HIV testing was not routinely performed on all participants; our analyses included children identified as HIV-infected based on medical history or clinical suspicion and confirmed by polymerase chain reaction or antibody testing', '15459 children enrolled in the trial, at least 1953 were tested for HIV and 153 were confirmed as HIV-infected (R3R: 51; R3C: 54; C3C: 48', 'Infants 6-12 weeks and children 5-17 months old', 'HIV-infected children', 'infants and children identified as HIV-infected during a randomized trial in sub-Saharan Africa']","['RTS,S/AS01 malaria vaccine', '4 RTS,S/AS01 doses (R3R group), 3 RTS,S/AS01 doses plus 1 comparator vaccine dose (R3C group), or 4 comparator vaccine doses (C3C group']","['antibody concentrations', 'Safety and immunogenicity', 'Serious adverse events (SAEs) and anti-circumsporozoite (CS) antibodies', 'safety profile of RTS,S/AS01']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3 (qualifier value)'}, {'cui': 'C0019693', 'cui_str': 'T-Lymphotropic Virus Type III Infections, Human'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0019665', 'cui_str': 'historical aspects'}, {'cui': 'C0242114', 'cui_str': 'Suspicion'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by (contextual qualifier) (qualifier value)'}, {'cui': 'C0032520', 'cui_str': 'PCR'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001738', 'cui_str': 'Subsaharan Africa'}]","[{'cui': 'C0206255', 'cui_str': 'Malarial Vaccines'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}]","[{'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",1953.0,0.137017,"RTS,S/AS01 was immunogenic in HIV-infected children but antibody concentrations were lower than in children with an unknown or negative HIV status. ","[{'ForeName': 'Lucas', 'Initials': 'L', 'LastName': 'Otieno', 'Affiliation': 'KEMRI-Walter Reed Project, Kombewa, Kenya. Electronic address: Lucas.Tina@usamru-k.org.'}, {'ForeName': 'Yolanda', 'Initials': 'Y', 'LastName': 'Guerra Mendoza', 'Affiliation': 'GSK, Wavre, Belgium. Electronic address: Yolanda.x.guerra@gsk.com.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Adjei', 'Affiliation': 'Kwame Nkrumah University of Science and Technology, Kumasi, Ghana. Electronic address: kwakusam@yahoo.com.'}, {'ForeName': 'Tsiri', 'Initials': 'T', 'LastName': 'Agbenyega', 'Affiliation': 'Kwame Nkrumah University of Science and Technology, Kumasi, Ghana. Electronic address: tsiri@ghana.com.'}, {'ForeName': 'Selidji Todagbe', 'Initials': 'ST', 'LastName': 'Agnandji', 'Affiliation': 'Centre de Recherches Médicales de Lambaréné, Lambaréné, Gabon and Institute of Tropical Medicine, University of Tübingen, Tübingen, Germany. Electronic address: agnandjis@lambarene.org.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Aide', 'Affiliation': 'Centro de Investigação em Saúde de Manhiça, Manhiça, Mozambique; National Institute of Health, Ministry of Health, Maputo, Mozambique. Electronic address: pedro.aide@manhica.net.'}, {'ForeName': 'Pauline', 'Initials': 'P', 'LastName': 'Akoo', 'Affiliation': 'Kenya Medical Research Institute-Wellcome Trust Research Programme, Centre for Geographic Medicine Research, Kilifi, Kenya. Electronic address: byancamy@gmail.com.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Ansong', 'Affiliation': 'Kwame Nkrumah University of Science and Technology, Kumasi, Ghana. Electronic address: ansongd@yahoo.com.'}, {'ForeName': 'Kwaku Poku', 'Initials': 'KP', 'LastName': 'Asante', 'Affiliation': 'Kintampo Health Research Center, Kintampo, Ghana. Electronic address: kwakupoku.asante@kintampo-hrc.org.'}, {'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'Berkley', 'Affiliation': 'Kenya Medical Research Institute-Wellcome Trust Research Programme, Centre for Geographic Medicine Research, Kilifi, Kenya; Centre for Tropical Medicine & Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, United Kingdom. Electronic address: JBerkley@kemri-wellcome.org.'}, {'ForeName': 'Samwel', 'Initials': 'S', 'LastName': 'Gesase', 'Affiliation': 'National Institute for Medical Research, Korogwe, Tanzania. Electronic address: sgesase@yahoo.com.'}, {'ForeName': 'Mary J', 'Initials': 'MJ', 'LastName': 'Hamel', 'Affiliation': 'Malaria Branch Division of Parasitic Diseases and Malaria, Center for Global Health, Centers for Disease Control and Prevention, Atlanta, GA, USA. Electronic address: hamelm@who.int.'}, {'ForeName': 'Irving', 'Initials': 'I', 'LastName': 'Hoffman', 'Affiliation': 'Department of Medicine, University of North Carolina, Chapel Hill, NC, USA. Electronic address: hoffmani@med.unc.edu.'}, {'ForeName': 'Seyram', 'Initials': 'S', 'LastName': 'Kaali', 'Affiliation': 'Kintampo Health Research Center, Kintampo, Ghana. Electronic address: kaali.seyram@kintampo-hrc.org.'}, {'ForeName': 'Portia', 'Initials': 'P', 'LastName': 'Kamthunzi', 'Affiliation': 'Department of Medicine, University of North Carolina, Chapel Hill, NC, USA. Electronic address: pkamthunzi@unclilongwe.org.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Kariuki', 'Affiliation': 'Kenya Medical Research Institute, Centre for Global Health Research, Kisumu, Kenya. Electronic address: SKariuki@kemricdc.org.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Kremsner', 'Affiliation': 'Centre de Recherches Médicales de Lambaréné, Lambaréné, Gabon and Institute of Tropical Medicine, University of Tübingen, Tübingen, Germany. Electronic address: peter.kremsner@uni-tuebingen.de.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Lanaspa', 'Affiliation': 'Centro de Investigação em Saúde de Manhiça, Manhiça, Mozambique; Barcelona Institute for Global Health (ISGlobal), Hospital Clínic-Universitat de Barcelona, Spain. Electronic address: mlanaspa@sjdhospitalbarcelona.org.'}, {'ForeName': 'Bertrand', 'Initials': 'B', 'LastName': 'Lell', 'Affiliation': 'Centre de Recherches Médicales de Lambaréné, Lambaréné, Gabon and Institute of Tropical Medicine, University of Tübingen, Tübingen, Germany. Electronic address: bertrand.lell@lambarene.org.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Lievens', 'Affiliation': 'GSK, Wavre, Belgium. Electronic address: marc.lievens@gsk.com.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Lusingu', 'Affiliation': 'National Institute for Medical Research, Korogwe, Tanzania. Electronic address: jpalusingu@yahoo.co.uk.'}, {'ForeName': 'Anangisye', 'Initials': 'A', 'LastName': 'Malabeja', 'Affiliation': 'National Institute for Medical Research, Korogwe, Tanzania. Electronic address: malabeja1@yahoo.com.'}, {'ForeName': 'Nahya Salim', 'Initials': 'NS', 'LastName': 'Masoud', 'Affiliation': 'Muhimbili University of Health and Allied Sciences (MUHAS), Dar es Salaam, Tanzania; Ifakara Health Institute, Bagamoyo, Tanzania. Electronic address: nsalim@ihi.or.tz.'}, {'ForeName': 'Ali Takadir', 'Initials': 'AT', 'LastName': 'Mtoro', 'Affiliation': 'Ifakara Health Institute, Bagamoyo, Tanzania. Electronic address: amtoro@ihi.or.tz.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Njuguna', 'Affiliation': 'Kenya Medical Research Institute-Wellcome Trust Research Programme, Centre for Geographic Medicine Research, Kilifi, Kenya; Pwani University, Kilifi, Kenya. Electronic address: njugunap@who.int.'}, {'ForeName': 'Opokua', 'Initials': 'O', 'LastName': 'Ofori-Anyinam', 'Affiliation': 'GSK, Wavre, Belgium. Electronic address: opokua.ofori-anyinam@gsk.com.'}, {'ForeName': 'Godfrey Allan', 'Initials': 'GA', 'LastName': 'Otieno', 'Affiliation': 'KEMRI-Walter Reed Project, Kombewa, Kenya. Electronic address: Allan.Otieno@usamru-k.org.'}, {'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Otieno', 'Affiliation': 'KEMRI-Walter Reed Project, Kombewa, Kenya. Electronic address: Walter.otieno@usamru-k.org.'}, {'ForeName': 'Seth', 'Initials': 'S', 'LastName': 'Owusu-Agyei', 'Affiliation': 'Kintampo Health Research Center, Kintampo, Ghana; Diseases Control Department, London School of Hygiene and Tropical Medicine, London, UK. Electronic address: seth.owusu-agyei@kintampo-hrc.org.'}, {'ForeName': 'Lode', 'Initials': 'L', 'LastName': 'Schuerman', 'Affiliation': 'GSK, Wavre, Belgium. Electronic address: lode.schuerman@gsk.com.'}, {'ForeName': 'Hermann', 'Initials': 'H', 'LastName': 'Sorgho', 'Affiliation': 'Institut de Recherche en Sciences de la Santé, Nanoro, Burkina Faso. Electronic address: hsorgho@hotmail.com.'}, {'ForeName': 'Marcel', 'Initials': 'M', 'LastName': 'Tanner', 'Affiliation': 'Muhimbili University of Health and Allied Sciences (MUHAS), Dar es Salaam, Tanzania; Ifakara Health Institute, Bagamoyo, Tanzania; Swiss Tropical and Public Health Institute, Basel, Switzerland and University of Basel, Basel, Switzerland. Electronic address: marcel.tanner@unibas.ch.'}, {'ForeName': 'Halidou', 'Initials': 'H', 'LastName': 'Tinto', 'Affiliation': 'Institut de Recherche en Sciences de la Santé, Nanoro, Burkina Faso. Electronic address: halidoutinto@gmail.com.'}, {'ForeName': 'Innocent', 'Initials': 'I', 'LastName': 'Valea', 'Affiliation': 'Institut de Recherche en Sciences de la Santé, Nanoro, Burkina Faso. Electronic address: innocentvalea@yahoo.fr.'}, {'ForeName': 'Pascale', 'Initials': 'P', 'LastName': 'Vandoolaeghe', 'Affiliation': 'GSK, Wavre, Belgium. Electronic address: pascale.vandoolaeghe@gsk.com.'}, {'ForeName': 'Jahit', 'Initials': 'J', 'LastName': 'Sacarlal', 'Affiliation': 'Centro de Investigação em Saúde de Manhiça, Manhiça, Mozambique; Faculdade de Medicina, Universidade Eduardo Mondlane (UEM), Maputo, Mozambique. Electronic address: jahityash2002@gmail.com.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Oneko', 'Affiliation': 'Kenya Medical Research Institute, Centre for Global Health Research, Kisumu, Kenya. Electronic address: tinaoneko@gmail.com.'}]",Vaccine,['10.1016/j.vaccine.2019.10.077'] 818,31929374,Intravenous Ibuprofen Reduces Opioid Consumption During the Initial 48 Hours After Injury in Orthopedic Trauma Patients.,"OBJECTIVES To evaluate the efficacy of intravenous (IV) ibuprofen (Caldolor) administration in the management of acute pain in orthopedic trauma patients and to minimize opioid use. DESIGN Randomized controlled trial, double-blind, parallel, placebo-controlled. SETTING Level 1 Trauma Center. PATIENTS A total of 99 consecutive orthopedic trauma patients with fractures of the ribs, face, extremities, and/or pelvis were randomized to receive either 800 mg IV ibuprofen (53 patients) or placebo (44 patients) administered every 6 hours for a total of 8 doses within 48 hours of admission and the same PRN medications along with 20-mg IV/PO Pepcid twice a day. To establish pain reduction efficacy, the analysis was consequently performed in the modified intent-to-treat group that included 74 randomized subjects with a baseline pain score greater than 2. The primary outcomes were reduction in opioid consumption and decrease in pain intensity (PI). INTERVENTION Administration of study medications. OUTCOME MEASUREMENTS PI measured by Numerical Rating Scale, opioid consumption adjusted to morphine equivalent dose, and time to first narcotic administration. RESULTS The 2 groups had comparable baseline characteristics: age, sex distribution, mechanism of injury, type of injury, injury severity score, and PI. IV ibuprofen statistically significantly reduced opioid consumption compared with placebo during the initial 48-hour period (P = 0.017). PI calculated as PI differences was statistically different only at 8-hour interval after Caldolor administration. Time to first narcotic medication was significantly longer in the Caldolor group (hazard ratio: 1.640; 95% confidence interval, 1.009-2.665; P = 0.046). CONCLUSIONS IV ibuprofen provided adequate analgesia, prolonged time to first narcotic administration, and was opioid-sparing for the treatment of pain in orthopedic trauma patients, which makes Caldolor a recommended candidate for managing acute pain in the diverse orthopaedic trauma population. LEVEL OF EVIDENCE Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.",2020,"CONCLUSIONS IV ibuprofen provided adequate analgesia, prolonged time to first narcotic administration and was opioid-sparing for the treatment of pain in orthopedic trauma patients, which makes Caldolor® a recommended candidate for managing acute pain in the diverse orthopaedic trauma population. ","['74 randomized subjects with a baseline pain score greater than 2', 'Orthopedic Trauma Patients', 'orthopedic trauma patients', '99 consecutive orthopedic trauma patients with fractures of the ribs, face, extremities and/or pelvis']","['ibuprofen', 'Intravenous Ibuprofen', 'placebo', 'IV ibuprofen', 'ibuprofen (Caldolor®', '800 mg intravenous (IV) ibuprofen']","['Pain intensity measured by Numerical Rating Scale, opioid consumption adjusted to morphine equivalent dose and time to first narcotic administration', 'Opioid Consumption', 'Pain intensity calculated as pain intensity differences', 'Time to first narcotic medication', 'reduction in opioid consumption and decrease in pain intensity', 'opioid consumption']","[{'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C0043251', 'cui_str': 'Trauma'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}, {'cui': 'C0035561', 'cui_str': 'Ribs'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C0015385', 'cui_str': 'Limbs'}, {'cui': 'C0030797', 'cui_str': 'Pelvic Region'}]","[{'cui': 'C0020740', 'cui_str': 'Ibuprofen'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2702462', 'cui_str': 'Caldolor'}, {'cui': 'C3844106', 'cui_str': 'Eight hundred'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0222045'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0027415', 'cui_str': 'Narcotics'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0444686', 'cui_str': 'Calculated (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}]",74.0,0.533767,"CONCLUSIONS IV ibuprofen provided adequate analgesia, prolonged time to first narcotic administration and was opioid-sparing for the treatment of pain in orthopedic trauma patients, which makes Caldolor® a recommended candidate for managing acute pain in the diverse orthopaedic trauma population. ","[{'ForeName': 'Russell D', 'Initials': 'RD', 'LastName': 'Weisz', 'Affiliation': 'Delray Medical Center, Delray Beach, FL.'}, {'ForeName': 'Alexander A', 'Initials': 'AA', 'LastName': 'Fokin', 'Affiliation': 'Delray Medical Center, Delray Beach, FL.'}, {'ForeName': 'Vivian', 'Initials': 'V', 'LastName': 'Lerner', 'Affiliation': 'Delray Medical Center, Delray Beach, FL.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Flynt', 'Affiliation': 'PharPoint Research, Durham, NC.'}, {'ForeName': 'Ines', 'Initials': 'I', 'LastName': 'Macias-Perez', 'Affiliation': 'Cumberland Pharmaceuticals, Nashville, TN.'}, {'ForeName': 'Leo', 'Initials': 'L', 'LastName': 'Pavliv', 'Affiliation': 'Cumberland Pharmaceuticals, Nashville, TN.'}, {'ForeName': 'Maggie', 'Initials': 'M', 'LastName': 'Crawford', 'Affiliation': 'Delray Medical Center, Delray Beach, FL.'}, {'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Puente', 'Affiliation': 'Delray Medical Center, Delray Beach, FL.'}]",Journal of orthopaedic trauma,['10.1097/BOT.0000000000001733'] 819,31568587,Dose-dependent effect of aerobic exercise on inflammatory biomarkers in a randomized controlled trial of women at high risk of breast cancer.,"BACKGROUND Increased levels of inflammation are associated with many diseases, including cancer. Physical activity can lower breast cancer risk as well as levels of inflammation. The Women In Steady Exercise Research (WISER) Sister trial was a randomized controlled trial that investigated the effects of a dosed, moderate to vigorous, aerobic exercise intervention on levels of inflammation in premenopausal women who were at high risk of developing breast cancer. METHODS Participants were randomized to control (<75 minutes per week; 41 patients), low-dose exercise (150 minutes per week; 38 patients), or high-dose exercise (300 minutes per week; 37 patients) groups. The 5-menstrual cycles-long, home-based treadmill exercise intervention gradually increased in minutes per week and intensity up to a maximum of 80% of the age-predicted maximum heart rate. Blood was collected at baseline and at follow-up and assayed for chemokine (C-C motif) ligand 2 (CCL2), interleukin 10 (IL-10), interleukin 12 (IL-12), and tumor necrosis factor α (TNF-α). RESULTS A linear dose-response relationship was observed for the proinflammatory biomarkers CCL2 (%Δ of -5.44% in the control group, -0.03% in the low-dose exercise group, and 1.54% in the high-dose exercise group), IL-12 (%Δ of -21.5% in the control group, 38.2% in the low-dose exercise group, and 25.8% in the high-dose exercise group,) and TNF-α (%Δ of -4.69% in the control group, 9.51% in the low-dose exercise group, and 15.7% in the high-dose exercise group) but not for the anti-inflammatory biomarker IL-10 (%Δ of 5.05% in the control group, 6.05% in the low-dose exercise group, and 10.6% in the high-dose exercise group). For IL-12 and TNF-α, the percentage change was significantly higher in the low-dose (IL-12: P < .001; and TNF-α: P = .01) and high-dose (IL-12: P < .001; and TNF-α: P < .001) exercise groups compared with the control group. CONCLUSIONS Moderate to vigorous aerobic exercise appeared to increase levels of proinflammatory biomarkers in a dose-dependent manner in a population of healthy women at high risk of developing breast cancer. The results of the current study suggest that for healthy premenopausal women, the mechanism of reduced breast cancer risk observed in physically active individuals may not be a result of reduced levels of inflammation.",2020,"RESULTS A linear dose-response relationship was observed for the proinflammatory biomarkers CCL2 (%Δ of -5.44% in the control group, -0.03% in the low-dose exercise group, and 1.54% in the high-dose exercise group), IL-12 (%Δ of -21.5% in the control group, 38.2% in the low-dose exercise group, and 25.8% in the high-dose exercise group,) and TNF-α (%Δ of -4.69% in the control group, 9.51% in the low-dose exercise group, and 15.7% in the high-dose exercise group) but not for the anti-inflammatory biomarker IL-10 (%Δ of 5.05% in the control group, 6.05% in the low-dose exercise group, and 10.6% in the high-dose exercise group).","['Participants were randomized to control (<75\xa0minutes per week; 41 patients', 'healthy premenopausal women', 'women at high risk of breast cancer', 'premenopausal women who were at high risk of developing breast cancer']","['TNF-α', 'home-based treadmill exercise intervention', 'aerobic exercise intervention', 'low-dose exercise', 'Steady Exercise Research (WISER', 'aerobic exercise', 'vigorous aerobic exercise']","['interleukin 10 (IL-10), interleukin 12 (IL-12), and tumor necrosis factor α (TNF-α', 'IL-12', 'proinflammatory biomarkers', 'levels of inflammation', 'proinflammatory biomarkers CCL2']","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0332167', 'cui_str': 'High risk of (contextual qualifier) (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}]","[{'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0184069', 'cui_str': 'Treadmill, device (physical object)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0001701', 'cui_str': 'Exercise, Aerobic'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0205361', 'cui_str': 'Steady (qualifier value)'}, {'cui': 'C0035168'}]","[{'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0123759', 'cui_str': 'Interleukin-12'}, {'cui': 'C0041368', 'cui_str': 'Tumor Necrosis Factors'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}]",,0.0532071,"RESULTS A linear dose-response relationship was observed for the proinflammatory biomarkers CCL2 (%Δ of -5.44% in the control group, -0.03% in the low-dose exercise group, and 1.54% in the high-dose exercise group), IL-12 (%Δ of -21.5% in the control group, 38.2% in the low-dose exercise group, and 25.8% in the high-dose exercise group,) and TNF-α (%Δ of -4.69% in the control group, 9.51% in the low-dose exercise group, and 15.7% in the high-dose exercise group) but not for the anti-inflammatory biomarker IL-10 (%Δ of 5.05% in the control group, 6.05% in the low-dose exercise group, and 10.6% in the high-dose exercise group).","[{'ForeName': 'Jeremy S', 'Initials': 'JS', 'LastName': 'Haley', 'Affiliation': 'Department of Public Health Sciences, Pennsylvania State University, Hershey, Pennsylvania.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Hibler', 'Affiliation': 'Division of Cancer Epidemiology and Prevention, Department of Preventive Medicine, Feinberg School of Medicine, Northwestern University, Chicago, Illinois.'}, {'ForeName': 'Shouhao', 'Initials': 'S', 'LastName': 'Zhou', 'Affiliation': 'Department of Public Health Sciences, Pennsylvania State University, Hershey, Pennsylvania.'}, {'ForeName': 'Kathryn H', 'Initials': 'KH', 'LastName': 'Schmitz', 'Affiliation': 'Department of Public Health Sciences, Pennsylvania State University, Hershey, Pennsylvania.'}, {'ForeName': 'Kathleen M', 'Initials': 'KM', 'LastName': 'Sturgeon', 'Affiliation': 'Department of Public Health Sciences, Pennsylvania State University, Hershey, Pennsylvania.'}]",Cancer,['10.1002/cncr.32530'] 820,31666284,Comparative Effectiveness of Two Interventions to Increase Colorectal Cancer Screening for Those at Increased Risk Based on Family History: Results of a Randomized Trial.,"BACKGROUND First-degree relatives (FDR) of patients with colorectal cancer are at risk for colorectal cancer, but may not be up to date with colorectal cancer screening. We sought to determine whether a one-time recommendation about needing colorectal cancer screening using patient navigation (PN) was better than just receiving the recommendation only. METHODS Participants were FDRs of patients with Lynch syndrome-negative colorectal cancer from participating Ohio hospitals. FDRs from 259 families were randomized to a website intervention (528 individuals), which included a survey and personal colorectal cancer screening recommendation, while those from 254 families were randomized to the website plus telephonic PN intervention (515 individuals). Primary outcome was adherence to the personal screening recommendation (to get screened or not to get screened) received from the website. Secondary outcomes examined who benefited from adding PN. RESULTS At the end of the 14-month follow-up, 78.6% of participants were adherent to their recommendation for colorectal cancer screening with adherence similar between arms ( P = 0.14). Among those who received a recommendation to have a colonoscopy immediately, the website plus PN intervention significantly increased the odds of receiving screening, compared with the website intervention (OR: 2.98; 95% confidence interval, 1.68-5.28). CONCLUSIONS Addition of PN to a website intervention did not improve adherence to a colorectal cancer screening recommendation overall; however, the addition of PN was more effective in increasing adherence among FDRs who needed screening immediately. IMPACT These findings provide important information as to when the additional costs of PN are needed to assure colorectal cancer screening among those at high risk for colorectal cancer.",2020,"Among those who received a recommendation to have a colonoscopy immediately, the website plus PN intervention significantly increased the odds of receiving screening, compared to the website intervention (OR: 2.98, 95% CI: (1.68, 5.28). ","['528 individuals), which included a survey and personal CRC screening recommendation, while those from 254 families', 'for those at Increased Risk Based on Family History', '259 families', 'First degree relatives (FDRs) of colorectal cancer (CRC) patients', 'Participants were FDRs of Lynch syndrome negative CRC patients from participating Ohio hospitals']","['Two Interventions to Increase Colorectal Cancer Screening', 'website plus telephonic PN intervention', 'CRC screening using patient navigation (PN', 'website intervention']","['adherence to the personal screening recommendation (to get screened or not to get screened', 'odds of receiving screening']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0170127', 'cui_str': 'Calcibiotic Root Canal Sealer'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0019665', 'cui_str': 'historical aspects'}, {'cui': 'C0444502', 'cui_str': 'First degree (qualifier value)'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4552100', 'cui_str': 'Lynch Syndrome'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0028905', 'cui_str': 'Ohio'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}]","[{'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0170127', 'cui_str': 'Calcibiotic Root Canal Sealer'}, {'cui': 'C3494323', 'cui_str': 'Navigations, Patient'}]","[{'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}]",528.0,0.0678806,"Among those who received a recommendation to have a colonoscopy immediately, the website plus PN intervention significantly increased the odds of receiving screening, compared to the website intervention (OR: 2.98, 95% CI: (1.68, 5.28). ","[{'ForeName': 'Electra D', 'Initials': 'ED', 'LastName': 'Paskett', 'Affiliation': 'Comprehensive Cancer Center, The Ohio State University, Columbus, Ohio. electra.paskett@osumc.edu.'}, {'ForeName': 'Brittany M', 'Initials': 'BM', 'LastName': 'Bernardo', 'Affiliation': 'Comprehensive Cancer Center, The Ohio State University, Columbus, Ohio.'}, {'ForeName': 'Gregory S', 'Initials': 'GS', 'LastName': 'Young', 'Affiliation': 'Center for Biostatistics, Department of Biomedical Informatics, The Ohio State University, Columbus, Ohio.'}, {'ForeName': 'Mira L', 'Initials': 'ML', 'LastName': 'Katz', 'Affiliation': 'Comprehensive Cancer Center, The Ohio State University, Columbus, Ohio.'}, {'ForeName': 'Paul L', 'Initials': 'PL', 'LastName': 'Reiter', 'Affiliation': 'Comprehensive Cancer Center, The Ohio State University, Columbus, Ohio.'}, {'ForeName': 'Cathy M', 'Initials': 'CM', 'LastName': 'Tatum', 'Affiliation': 'Comprehensive Cancer Center, The Ohio State University, Columbus, Ohio.'}, {'ForeName': 'Jill M', 'Initials': 'JM', 'LastName': 'Oliveri', 'Affiliation': 'Comprehensive Cancer Center, The Ohio State University, Columbus, Ohio.'}, {'ForeName': 'Cecilia R', 'Initials': 'CR', 'LastName': 'DeGraffinreid', 'Affiliation': 'Comprehensive Cancer Center, The Ohio State University, Columbus, Ohio.'}, {'ForeName': 'Darrell Mason', 'Initials': 'DM', 'LastName': 'Gray', 'Affiliation': 'Comprehensive Cancer Center, The Ohio State University, Columbus, Ohio.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Pearlman', 'Affiliation': 'Division of Human Genetics, Department of Internal Medicine, The Ohio State University Comprehensive Cancer Center, Columbus, Ohio.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Hampel', 'Affiliation': 'Division of Human Genetics, Department of Internal Medicine, The Ohio State University Comprehensive Cancer Center, Columbus, Ohio.'}]","Cancer epidemiology, biomarkers & prevention : a publication of the American Association for Cancer Research, cosponsored by the American Society of Preventive Oncology",['10.1158/1055-9965.EPI-19-0797'] 821,31914959,Advancing successful implementation of task-shifted mental health care in low-resource settings (BASIC): protocol for a stepped wedge cluster randomized trial.,"BACKGROUND The mental health treatment gap-the difference between those with mental health need and those who receive treatment-is high in low- and middle-income countries. Task-shifting has been used to address the shortage of mental health professionals, with a growing body of research demonstrating the effectiveness of mental health interventions delivered through task-shifting. However, very little research has focused on how to embed, support, and sustain task-shifting in government-funded systems with potential for scale up. The goal of the Building and Sustaining Interventions for Children (BASIC) study is to examine implementation policies and practices that predict adoption, fidelity, and sustainment of a mental health intervention in the education sector via teacher delivery and the health sector via community health volunteer delivery. METHODS BASIC is a Hybrid Type II Implementation-Effectiveness trial. The study design is a stepped wedge, cluster randomized trial involving 7 sequences of 40 schools and 40 communities surrounding the schools. Enrollment consists of 120 teachers, 120 community health volunteers, up to 80 site leaders, and up to 1280 youth and one of their primary guardians. The evidence-based mental health intervention is a locally adapted version of Trauma-focused Cognitive Behavioral Therapy, called Pamoja Tunaweza. Lay counselors are trained and supervised in Pamoja Tunaweza by local trainers who are experienced in delivering the intervention and who participated in a Train-the-Trainer model of skills transfer. After the first sequence completes implementation, in-depth interviews are conducted with initial implementing sites' counselors and leaders. Findings are used to inform delivery of implementation facilitation for subsequent sequences' sites. We use a mixed methods approach including qualitative comparative analysis to identify necessary and sufficient implementation policies and practices that predict 3 implementation outcomes of interest: adoption, fidelity, and sustainment. We also examine child mental health outcomes and cost of the intervention in both the education and health sectors. DISCUSSION The BASIC study will provide knowledge about how implementation of task-shifted mental health care can be supported in government systems that already serve children and adolescents. Knowledge about implementation policies and practices from BASIC can advance the science of implementation in low-resource contexts. TRIAL REGISTRATION Trial Registration: ClinicalTrials.gov Identifier: NCT03243396. Registered 9th August 2017, https://clinicaltrials.gov/ct2/show/NCT03243396.",2020,"The evidence-based mental health intervention is a locally adapted version of Trauma-focused Cognitive Behavioral Therapy, called Pamoja Tunaweza.","['7 sequences of 40 schools and 40 communities surrounding the schools', '120 teachers, 120 community health volunteers, up to 80\xa0site leaders, and up to 1280 youth\xa0and one\xa0of their primary guardians', 'Children (BASIC']",[],[],"[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C1282914', 'cui_str': 'Surrounding (qualifier value)'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0221457', 'cui_str': 'Teacher (occupation)'}, {'cui': 'C0034019', 'cui_str': 'Community Health'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C1274041', 'cui_str': 'Guardian'}, {'cui': 'C0008059', 'cui_str': 'Child'}]",[],[],7.0,0.096861,"The evidence-based mental health intervention is a locally adapted version of Trauma-focused Cognitive Behavioral Therapy, called Pamoja Tunaweza.","[{'ForeName': 'Shannon', 'Initials': 'S', 'LastName': 'Dorsey', 'Affiliation': 'Department of Psychology, University of Washington Guthrie Hall 119A, Box 351525, Seattle, WA, 98195, USA. dorsey2@uw.edu.'}, {'ForeName': 'Christine L', 'Initials': 'CL', 'LastName': 'Gray', 'Affiliation': 'Center for Health Policy and Inequalities Research, Duke Global Health Institute, Duke University, Campus Box 90392, Durham, NC, 27710, USA.'}, {'ForeName': 'Augustine I', 'Initials': 'AI', 'LastName': 'Wasonga', 'Affiliation': 'Research Department, Ace Africa Kenya, P.O. Box 1185, Bungoma, 50200, Kenya.'}, {'ForeName': 'Cyrilla', 'Initials': 'C', 'LastName': 'Amanya', 'Affiliation': 'Research Department, Ace Africa Kenya, P.O. Box 1185, Bungoma, 50200, Kenya.'}, {'ForeName': 'Bryan J', 'Initials': 'BJ', 'LastName': 'Weiner', 'Affiliation': 'Department of Global Health, University of Washington, Harris Hydraulics Laboratory, 1510 San Juan Road, Seattle, WA, 98195, USA.'}, {'ForeName': 'C Micha', 'Initials': 'CM', 'LastName': 'Belden', 'Affiliation': 'Center for Health Policy and Inequalities Research, Duke Global Health Institute, Duke University, Campus Box 90392, Durham, NC, 27710, USA.'}, {'ForeName': 'Prerna', 'Initials': 'P', 'LastName': 'Martin', 'Affiliation': 'Department of Psychology, University of Washington Guthrie Hall 119A, Box 351525, Seattle, WA, 98195, USA.'}, {'ForeName': 'Rosemary D', 'Initials': 'RD', 'LastName': 'Meza', 'Affiliation': 'Department of Psychology, University of Washington Guthrie Hall 119A, Box 351525, Seattle, WA, 98195, USA.'}, {'ForeName': 'Andrew K', 'Initials': 'AK', 'LastName': 'Weinhold', 'Affiliation': 'Center for Health Policy and Inequalities Research, Duke Global Health Institute, Duke University, Campus Box 90392, Durham, NC, 27710, USA.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Soi', 'Affiliation': 'Department of Global Health, University of Washington, Harris Hydraulics Laboratory, 1510 San Juan Road, Seattle, WA, 98195, USA.'}, {'ForeName': 'Laura K', 'Initials': 'LK', 'LastName': 'Murray', 'Affiliation': 'Department of Mental Health, Johns Hopkins Bloomberg School of Public Health, 624 N. Broadway, 8th floor, Baltimore, MD, 21205, USA.'}, {'ForeName': 'Leah', 'Initials': 'L', 'LastName': 'Lucid', 'Affiliation': 'Department of Psychology, University of Washington Guthrie Hall 119A, Box 351525, Seattle, WA, 98195, USA.'}, {'ForeName': 'Elizabeth L', 'Initials': 'EL', 'LastName': 'Turner', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Duke University School of Medicine, Duke University, Durham, NC, 27710, USA.'}, {'ForeName': 'Robyn', 'Initials': 'R', 'LastName': 'Mildon', 'Affiliation': 'Centre for Evidence and Implementation, 33 Lincoln Square South, Carlton, Victoria, 3053, Australia.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Whetten', 'Affiliation': 'Center for Health Policy and Inequalities Research, Duke Global Health Institute, Duke University, Campus Box 90392, Durham, NC, 27710, USA.'}]",BMC psychiatry,['10.1186/s12888-019-2364-4'] 822,30834647,Comprehensive medication reviews by ward-based pharmacists in Swedish hospitals: What does the patient have to say?,"RATIONALE, AIMS, AND OBJECTIVES Inappropriate medication prescribing and use amongst older patients is a major patient safety and health care problem. To promote appropriate medication prescribing and use, comprehensive medication reviews (CMRs) by ward-based pharmacists, including follow-up telephone calls after hospital discharge, have been conducted in older patients in the context of a randomized controlled trial (RCT). One of the key actors in a CMR is the patient. To support the understanding of the effects of CMRs on patients' health outcomes and improve clinical practice, knowledge about the patient perspective is needed. We therefore aimed to explore older patients' experiences with, and views on, hospital-initiated CMRs and follow-up telephone calls by ward-based clinical pharmacists within an RCT. METHODS We conducted in-depth semi-structured interviews with 15 patients (66-94 years) and carers from four hospitals in Sweden. Discussion topics included communication, information, decision-making, and effects on the patient. Interviews took place after discharge, were audio-recorded, transcribed verbatim, and thematically analysed using a framework approach. RESULTS In general, patients' experiences and views were positive. Seven key themes were identified: (a) feeling of being taken care of and heterogenous health effects; (b) the pharmacist is competent; (c) despite the unclear role of pharmacists, their involvement is appreciated; (d) patients rely on health care professionals for decision-making; (e) importance of being informed, but receiving and retaining information is problematic; (f) time, location, and other factors influencing the effectiveness of CMRs; and (g) generic substitution is a problem. CONCLUSIONS Older patients generally have positive experiences with and views on CMRs and follow-up telephone calls. However, some factors, like the unclear role of the ward-based pharmacist and problems with receiving and retaining information, may negatively impact the effectiveness of these interventions. Future initiatives on hospital-initiated CMRs by clinical pharmacists should address these negative factors and utilize the positive views.",2020,"In general, patients' experiences and views were positive.","['Older patients', '15 patients (66-94\xa0years) and carers from four hospitals in Sweden', 'older patients', ""older patients' experiences with, and views on, hospital-initiated CMRs and follow-up telephone calls by ward-based clinical pharmacists within an RCT"", 'ward-based pharmacists in Swedish hospitals']",['CMRs'],['feeling of being taken care of and heterogenous health effects'],"[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1305660', 'cui_str': 'Carer (occupation)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}, {'cui': 'C0449911', 'cui_str': 'View (attribute)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C1305702', 'cui_str': 'Ward (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1449564', 'cui_str': 'Clinical Pharmacists'}, {'cui': 'C0031323', 'cui_str': 'Pharmacist'}]",[],"[{'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}]",,0.0780396,"In general, patients' experiences and views were positive.","[{'ForeName': 'Thomas G H', 'Initials': 'TGH', 'LastName': 'Kempen', 'Affiliation': 'Department of Medical Sciences, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Kälvemark', 'Affiliation': 'Department of Medical Sciences, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Ulrika', 'Initials': 'U', 'LastName': 'Gillespie', 'Affiliation': 'Department of Medical Sciences, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Derek', 'Initials': 'D', 'LastName': 'Stewart', 'Affiliation': 'School of Pharmacy and Life Sciences, Robert Gordon University, Aberdeen, UK.'}]",Journal of evaluation in clinical practice,['10.1111/jep.13121'] 823,29902649,Safety and Efficacy of Budesonide Oral Suspension Maintenance Therapy in Patients With Eosinophilic Esophagitis.,"BACKGROUND & AIMS We aimed to determine the safety and efficacy of budesonide oral suspension (BOS) maintenance therapy in patients with eosinophilic esophagitis (EoE). METHODS We performed an open-label extension study of a 12-week, multicenter, randomized, double-blind, placebo-controlled trial. Patients with EoE (11-40 years old) who completed double-blind BOS (n = 45) or placebo therapy (n = 37) received 24 weeks' open-label BOS (2.0 mg once daily for 12 weeks, with optional dose increase [1.5-2.0 mg twice daily] for 12 weeks thereafter). Predefined efficacy outcomes included: proportion of patients with a histologic response (≤6 eosinophils/high-power field [eos/hpf]) and change in mean peak eosinophil counts after 24 weeks. Analyses were stratified by patients who received placebo (placebo/BOS) or BOS (BOS/BOS) during the double-blind trial. RESULTS BOS was well tolerated and drug-related adverse events were uncommon (placebo/BOS, 19% [7/37]; BOS/BOS, 4% [2/45]). Incidence of oral candidiasis (1 per group) and esophageal candidiasis (placebo/BOS group, n = 4) remained low. Changes in morning serum cortisol levels were not clinically relevant. A histologic response was observed in 49% (16/33) of patients receiving placebo/BOS and 23% (9/39) receiving BOS/BOS. Mean peak eosinophil counts (baseline vs week 24 or early termination) were: placebo/BOS, 118.8 vs 29.1; P < .001 and BOS/BOS, 38.1 vs 72.4; P = .01. Of the patients who responded to double-blind therapy, 42% maintained a histologic response during the open-label extension; 4% of nonresponders gained response. CONCLUSIONS In an open-label extension study of patients with EoE, BOS was well tolerated and drug-related adverse events were uncommon. BOS maintained a histologic response in some initial responders, but few initial nonresponders had a response. ClinicalTrials.gov no: NCT01642212.",2019,"Mean peak eosinophil counts (baseline vs week 24 or early termination) were: placebo/BOS, 118.8 vs 29.1; P < .001 and BOS/BOS, 38.1 vs 72.4; P = .01.","['Patients with EoE (11-40 years old) who completed double-blind BOS (n = 45) or', 'patients with eosinophilic esophagitis (EoE', 'Patients With Eosinophilic Esophagitis']","['placebo', 'Budesonide Oral Suspension Maintenance Therapy', 'budesonide oral suspension (BOS) maintenance\xa0therapy', 'placebo therapy', 'placebo/BOS', 'placebo (placebo/BOS) or BOS (BOS/BOS', ""24 weeks' open-label BOS""]","['safety and efficacy', 'esophageal candidiasis', 'morning serum cortisol levels', 'Mean peak eosinophil counts', 'Incidence of oral candidiasis', 'proportion of patients with a histologic response (≤6 eosinophils/high-power field [eos/hpf]) and change in mean peak eosinophil counts', 'tolerated and drug-related adverse events', 'Safety and Efficacy', 'BOS maintained a histologic response', 'histologic response']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0341106', 'cui_str': 'Chronic Esophagitis, Eosinophilic'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0054201', 'cui_str': 'Budesonide'}, {'cui': 'C0991537', 'cui_str': 'Oral Suspension'}, {'cui': 'C0677908', 'cui_str': 'Maintenance therapy'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0332170', 'cui_str': 'Morning (qualifier value)'}, {'cui': 'C0236396', 'cui_str': 'Serum cortisol measurement'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0200638', 'cui_str': 'Eosinophil count - observation'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205462', 'cui_str': 'Histologic (qualifier value)'}, {'cui': 'C0014467', 'cui_str': 'Eosinophil, segmented (cell)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0440042', 'cui_str': ""Field's""}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1314677', 'cui_str': 'Maintained'}]",,0.376077,"Mean peak eosinophil counts (baseline vs week 24 or early termination) were: placebo/BOS, 118.8 vs 29.1; P < .001 and BOS/BOS, 38.1 vs 72.4; P = .01.","[{'ForeName': 'Evan S', 'Initials': 'ES', 'LastName': 'Dellon', 'Affiliation': 'Center for Esophageal Diseases and Swallowing, Division of Gastroenterology and Hepatology, Department of Medicine, University of North Carolina, Chapel Hill, North Carolina. Electronic address: edellon@med.unc.edu.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Katzka', 'Affiliation': 'Division of Gastroenterology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Margaret H', 'Initials': 'MH', 'LastName': 'Collins', 'Affiliation': ""Division of Pathology and Laboratory Medicine, Cincinnati Children's Hospital Medical Center and University of Cincinnati College of Medicine, Cincinnati, Ohio.""}, {'ForeName': 'Sandeep K', 'Initials': 'SK', 'LastName': 'Gupta', 'Affiliation': ""Section of Pediatric Gastroenterology, Hepatology and Nutrition, Children's Hospital of Illinois, and College of Medicine, University of Illinois, Peoria, Illinois.""}, {'ForeName': 'Lan', 'Initials': 'L', 'LastName': 'Lan', 'Affiliation': 'Shire, Lexington, Massachusetts.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Williams', 'Affiliation': 'Shire, Lexington, Massachusetts.'}, {'ForeName': 'Ikuo', 'Initials': 'I', 'LastName': 'Hirano', 'Affiliation': 'Division of Gastroenterology and Hepatology, Northwestern University Feinberg School of Medicine, Chicago, Illinois.'}]",Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association,['10.1016/j.cgh.2018.05.051'] 824,31860172,Randomized controlled trial of a positive affect intervention to reduce HIV viral load among sexual minority men who use methamphetamine.,"INTRODUCTION In the era of HIV treatment as prevention (TasP), evidence-based interventions that optimize viral suppression among people who use stimulants such as methamphetamine are needed to improve health outcomes and reduce onward transmission risk. We tested the efficacy of positive affect intervention delivered during community-based contingency management (CM) for reducing viral load in sexual minority men living with HIV who use methamphetamine. METHODS Conducted in San Francisco, this Phase II randomized controlled trial tested the efficacy of a positive affect intervention for boosting and extending the effectiveness of community-based CM for stimulant abstinence to achieve more durable reductions in HIV viral load. From 2013 to 2017, 110 sexual minority men living with HIV who had biologically confirmed, recent methamphetamine use were randomized to receive a positive affect intervention (n = 55) or attention-control condition (n = 55). All individual positive affect intervention and attention-control sessions were delivered during three months of community-based CM where participants received financial incentives for stimulant abstinence. The 5-session positive affect intervention was designed to provide skills for managing stimulant withdrawal symptoms as well as sensitize individuals to natural sources of reward. The attention-control condition consisted of neutral writing exercises and self-report measures. RESULTS Men randomized to the positive affect intervention displayed significantly lower log 10 HIV viral load at six, twelve and fifteen months compared to those in the attention-control condition. Men in the positive affect intervention also had significantly lower risk of at least one unsuppressed HIV RNA (≥200 copies/mL) over the 15-month follow-up. There were concurrent, statistically significant intervention-related increases in positive affect as well as decreases in the self-reported frequency of stimulant use at six and twelve months. CONCLUSIONS Delivering a positive affect intervention during community-based CM with sexual minority men who use methamphetamine achieved durable and clinically meaningful reductions in HIV viral load that were paralleled by increases in positive affect and decreases in stimulant use. Further clinical research is needed to determine the effectiveness of integrative, behavioural interventions for optimizing the clinical and public health benefits of TasP in sexual minority men who use stimulants such as methamphetamine.",2019,"Men randomized to the positive affect intervention displayed significantly lower log 10 HIV viral load at six, twelve and fifteen months compared to those in the attention-control condition.","['sexual minority men living with HIV who use methamphetamine', 'sexual minority men who use', 'Conducted in San Francisco', 'sexual minority men who use stimulants such as methamphetamine', 'From 2013 to 2017, 110 sexual minority men living with HIV who had biologically confirmed, recent methamphetamine use']","['positive affect intervention (n\xa0=\xa055) or attention-control condition', 'methamphetamine', 'positive affect intervention', 'neutral writing exercises and self-report measures', 'community-based contingency management (CM']","['log 10 HIV viral load', 'HIV viral load']","[{'cui': 'C4277573', 'cui_str': 'Sexual and Gender Minorities'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0025611', 'cui_str': 'metamfetamine'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0036152', 'cui_str': 'San Francisco'}, {'cui': 'C0242977', 'cui_str': 'Stimulants, Historical'}, {'cui': 'C4517536', 'cui_str': '110 (qualifier value)'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}]","[{'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0025611', 'cui_str': 'metamfetamine'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C1168369', 'cui_str': 'HIV viral load'}]",,0.110968,"Men randomized to the positive affect intervention displayed significantly lower log 10 HIV viral load at six, twelve and fifteen months compared to those in the attention-control condition.","[{'ForeName': 'Adam W', 'Initials': 'AW', 'LastName': 'Carrico', 'Affiliation': 'University of Miami School of Medicine, Miami, FL, USA.'}, {'ForeName': 'Torsten B', 'Initials': 'TB', 'LastName': 'Neilands', 'Affiliation': 'San Francisco School of Medicine, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Samantha E', 'Initials': 'SE', 'LastName': 'Dilworth', 'Affiliation': 'San Francisco School of Medicine, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Evans', 'Affiliation': 'San Francisco School of Medicine, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Gόmez', 'Affiliation': 'Berkeley School of Social Welfare, University of California, Berkeley, CA, USA.'}, {'ForeName': 'Jennifer P', 'Initials': 'JP', 'LastName': 'Jain', 'Affiliation': 'San Diego School of Medicine, University of California, La Jolla, CA, USA.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Gandhi', 'Affiliation': 'San Francisco School of Medicine, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Shoptaw', 'Affiliation': 'Departments of Family Medicine and Psychiatry, Los Angeles David Geffen School of Medicine, University of California, Los Angeles, CA, USA.'}, {'ForeName': 'Keith J', 'Initials': 'KJ', 'LastName': 'Horvath', 'Affiliation': 'Department of Psychology, San Diego State University, San Diego, CA, USA.'}, {'ForeName': 'Lara', 'Initials': 'L', 'LastName': 'Coffin', 'Affiliation': 'San Francisco School of Medicine, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Michael V', 'Initials': 'MV', 'LastName': 'Discepola', 'Affiliation': 'San Francisco AIDS Foundation, San Francisco, CA, USA.'}, {'ForeName': 'Rick', 'Initials': 'R', 'LastName': 'Andrews', 'Affiliation': 'San Francisco AIDS Foundation, San Francisco, CA, USA.'}, {'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Woods', 'Affiliation': 'San Francisco School of Medicine, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Feaster', 'Affiliation': 'University of Miami School of Medicine, Miami, FL, USA.'}, {'ForeName': 'Judith T', 'Initials': 'JT', 'LastName': 'Moskowitz', 'Affiliation': 'Department of Medical Social Sciences, Northwestern University, Chicago, CA, USA.'}]",Journal of the International AIDS Society,['10.1002/jia2.25436'] 825,31567674,A Multicenter Randomized Controlled Trial Evaluating the Effectiveness of Cognitive Training for Anterior Approach Total Hip Arthroplasty.,"BACKGROUND For total hip arthroplasty (THA), cognitive training prior to performing real surgery may be an effective adjunct alongside simulation to shorten the learning curve. This study sought to create a cognitive training tool (CTT) to perform anterior approach (AA)-THA, which was validated by expert surgeons, and test its use as a training tool compared with conventional material. METHODS We employed a modified Delphi method with 4 expert surgeons from 3 international centers of excellence. Surgeons were independently observed performing THA before undergoing semistructured cognitive task analysis (CTA) and before completing successive rounds of surveys until a consensus was reached. Thirty-six surgical residents (postgraduate year [PGY]-1 through PGY-4) were randomized to cognitive training or training with a standard operation manual with surgical videos before performing a simulated AA-THA. RESULTS The consensus CTA defined THA in 11 phases, in which were embedded 46 basic steps, 36 decision points, and 42 critical errors and linked strategies. This CTA was mapped onto an open-access web-based CTT. Surgeons who prepared with the CTT performed a simulated THA 35% more quickly (time, mean 28 versus 38 minutes) with 69% fewer errors in instrument selection (mean 29 versus 49 instances), and required 92% fewer prompts (mean 13 versus 25 instances). They were more accurate in acetabular cup orientation (inclination error, mean 8° versus 10°; anteversion error, mean 14° versus 22°). CONCLUSIONS This validated CTT for arthroplasty provides structure for competency-based learning. It is more effective at preparing orthopaedic trainees for a complex procedure than conventional materials, as well as for learning sequence, instrumentation utilization, and motor skills. CLINICAL RELEVANCE Cognitive training combines education on decision-making, knowledge, and technical skill. It is an inexpensive technique to teach surgeons to perform hip arthroplasty and is more effective than current preparation methods.",2020,"Surgeons who prepared with the CTT performed a simulated THA 35% more quickly (time, mean 28 versus 38 minutes) with 69% fewer errors in instrument selection (mean 29 versus 49 instances), and required 92% fewer prompts (mean 13 versus 25 instances).","['Thirty-six surgical residents (postgraduate year [PGY]-1 through PGY-4', 'Anterior Approach Total Hip Arthroplasty', '4 expert surgeons from 3 international centers of excellence']","['cognitive training tool (CTT', 'total hip arthroplasty (THA), cognitive training', 'Cognitive Training', 'cognitive training or training with a standard operation manual with surgical videos before performing a simulated AA-THA']",['acetabular cup orientation'],"[{'cui': 'C4319606', 'cui_str': 'Thirty-six'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205511', 'cui_str': 'Anterior approach (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0186193', 'cui_str': 'Arthroplasty of coxofemoral joint'}, {'cui': 'C0582175', 'cui_str': 'Surgeon (occupation)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]","[{'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0336791', 'cui_str': 'Tool, device (physical object)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0186193', 'cui_str': 'Arthroplasty of coxofemoral joint'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0038895', 'cui_str': 'operative therapy'}, {'cui': 'C0175674', 'cui_str': 'Manual (qualifier value)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0642413', 'cui_str': 'THAS'}]","[{'cui': 'C2949743', 'cui_str': 'Cup - unit of product usage'}, {'cui': 'C0029266', 'cui_str': 'Cognitive Orientation'}]",36.0,0.0561386,"Surgeons who prepared with the CTT performed a simulated THA 35% more quickly (time, mean 28 versus 38 minutes) with 69% fewer errors in instrument selection (mean 29 versus 49 instances), and required 92% fewer prompts (mean 13 versus 25 instances).","[{'ForeName': 'Kartik', 'Initials': 'K', 'LastName': 'Logishetty', 'Affiliation': 'The MSk Lab, Department of Surgery and Cancer, Imperial College London, London, United Kingdom.'}, {'ForeName': 'Wade T', 'Initials': 'WT', 'LastName': 'Gofton', 'Affiliation': 'Division of Orthopaedic Surgery, The Ottawa Hospital, Ottawa, Ontario, Canada.'}, {'ForeName': 'Branavan', 'Initials': 'B', 'LastName': 'Rudran', 'Affiliation': 'The MSk Lab, Department of Surgery and Cancer, Imperial College London, London, United Kingdom.'}, {'ForeName': 'Paul E', 'Initials': 'PE', 'LastName': 'Beaulé', 'Affiliation': 'Division of Orthopaedic Surgery, The Ottawa Hospital, Ottawa, Ontario, Canada.'}, {'ForeName': 'Chinmay M', 'Initials': 'CM', 'LastName': 'Gupte', 'Affiliation': 'The MSk Lab, Department of Surgery and Cancer, Imperial College London, London, United Kingdom.'}, {'ForeName': 'Justin P', 'Initials': 'JP', 'LastName': 'Cobb', 'Affiliation': 'The MSk Lab, Department of Surgery and Cancer, Imperial College London, London, United Kingdom.'}]",The Journal of bone and joint surgery. American volume,['10.2106/JBJS.19.00121'] 826,31627728,The analgesic efficacy of ultrasound-guided transversus abdominis plane block for retroperitoneoscopic renal surgery: a randomized controlled study.,"BACKGROUND Ultrasound-guided lateral transversus abdominis plane (TAP) block can provide definite analgesia to the anterior abdominal wall. However, whether this method is useful in renal surgery through the lateral abdominal wall pathway remains unknown. The study aimed to evaluate the analgesic efficacy of lateral TAP block for retroperitoneoscopic partial or radical nephrectomy. METHOD In this prospective, randomized, double-blind, placebo-controlled trial, eligible patients were randomized into two groups. After anaesthesia induction, ultrasound-guided lateral TAP block was performed with either 30 ml of 0.4% ropivacaine (Group T) or an equivalent volume of normal saline (Group C). The primary outcomes were opioid consumption during surgery and in the first 24 h after surgery. Secondary outcomes included postsurgical pain intensity immediately awakening from anaesthesia and at 0.5, 1, 2, 6, 12, and 24 h after surgery, as well as recovery variables including the incidence of postoperative nausea and vomiting (PONV), sleep quality, time to first ambulation, drainage and length of hospital stay. RESULTS A total of 104 patients were enrolled and randomized (53 in Group T and 51 in Group C). Laparoscopic surgery was converted to open surgery in one patient of Group T; this patient was excluded from the outcome analysis. The opioid consumption during surgery (intravenous morphine equivalent dose: median 35.0 mg [interquartile range 18.0, 49.6] in Group C vs. 40.3 mg [20.9, 59.0] in Group T, P = 0.281) and in the first 24 h after surgery (10.8 mg [7.8, 21.7] in Group C vs. 13.2 mg [8.0, 26.6] in Group T, P = 0.311) did not differ significantly between groups. There were no significant differences between groups regarding the pain intensity at all time points after surgery and the recovery variables (all P > 0.05). CONCLUSIONS Our results showed that, in patients undergoing retroperitoneoscopic renal surgery, preoperative lateral TAP did not decrease intra- and postoperative opioid consumption, nor did it relieve pain intensity or promote postoperative recovery in the first 24 h after surgery. However, the trial might be underpowered. TRIAL REGISTRATION This study was registered on November 4, 2017, in the Chinese Clinical Trail Registry with the identification number ChiCTR-INR-17013244 .",2019,"There were no significant differences between groups regarding the pain intensity at all time points after surgery and the recovery variables (all P > 0.05). ","['104 patients', 'registered on November 4, 2017, in the Chinese Clinical Trail Registry with the identification number ChiCTR-INR-17013244 ', 'patients undergoing retroperitoneoscopic renal surgery', 'retroperitoneoscopic renal surgery', 'eligible patients']","['ultrasound-guided transversus abdominis plane block', 'ultrasound-guided lateral TAP block', 'Laparoscopic surgery', 'placebo', 'ropivacaine (Group T) or an equivalent volume of normal saline', 'morphine equivalent dose', 'Ultrasound-guided lateral transversus abdominis plane (TAP) block', 'retroperitoneoscopic partial or radical nephrectomy', 'lateral TAP block']","['analgesic efficacy', 'intra- and postoperative opioid consumption', 'pain intensity or promote postoperative recovery', 'postsurgical pain intensity immediately awakening from anaesthesia and at 0.5, 1, 2, 6, 12, and 24\u2009h after surgery, as well as recovery variables including the incidence of postoperative nausea and vomiting (PONV), sleep quality, time to first ambulation, drainage and length of hospital stay', 'opioid consumption during surgery and in the first 24\u2009h after surgery', 'pain intensity']","[{'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C1300638', 'cui_str': 'Identification number'}, {'cui': 'C0525032', 'cui_str': 'INR'}, {'cui': 'C0194053', 'cui_str': 'Kidney operation (procedure)'}]","[{'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0444660', 'cui_str': 'Plane (attribute)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0205093', 'cui_str': 'Lateral (qualifier value)'}, {'cui': 'C0034115', 'cui_str': 'Puncture and Drainage'}, {'cui': 'C0751429', 'cui_str': 'Surgical Procedures, Laparoscopic'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0036669', 'cui_str': 'T-Groups'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C0401181', 'cui_str': 'Radical nephrectomy (procedure)'}]","[{'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0520909', 'cui_str': 'PONV'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0945826', 'cui_str': 'Ambulation'}, {'cui': 'C0013103', 'cui_str': 'Drainage'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]",104.0,0.249089,"There were no significant differences between groups regarding the pain intensity at all time points after surgery and the recovery variables (all P > 0.05). ","[{'ForeName': 'Xue', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Department of Anesthesiology, Peking University First Hospital, No. 7 Xishiku Street, Xicheng District, Beijing, 100034, China.'}, {'ForeName': 'Zhen-Zhen', 'Initials': 'ZZ', 'LastName': 'Xu', 'Affiliation': 'Department of Anesthesiology, Peking University First Hospital, No. 7 Xishiku Street, Xicheng District, Beijing, 100034, China.'}, {'ForeName': 'Xue-Ying', 'Initials': 'XY', 'LastName': 'Li', 'Affiliation': 'Department of Biostatics, Peking University First Hospital, No. 7 Xishiku Street, Xicheng District, Beijing, 100034, China.'}, {'ForeName': 'Ting-Ting', 'Initials': 'TT', 'LastName': 'Jiang', 'Affiliation': 'Department of Anesthesiology, Peking University First Hospital, No. 7 Xishiku Street, Xicheng District, Beijing, 100034, China.'}, {'ForeName': 'Zeng-Mao', 'Initials': 'ZM', 'LastName': 'Lin', 'Affiliation': 'Department of Anesthesiology, Peking University First Hospital, No. 7 Xishiku Street, Xicheng District, Beijing, 100034, China. linzengmao@163.com.'}, {'ForeName': 'Dong-Xin', 'Initials': 'DX', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, Peking University First Hospital, No. 7 Xishiku Street, Xicheng District, Beijing, 100034, China.'}]",BMC anesthesiology,['10.1186/s12871-019-0850-3'] 827,31629404,"Respiratory muscle activity after spontaneous, neostigmine- or sugammadex-enhanced recovery of neuromuscular blockade: a double blind prospective randomized controlled trial.","BACKGROUND The use of neostigmine after neuromuscular blockade (NMB) has been associated with postoperative respiratory complications. In previous studies, we found lower diaphragmatic activity after neostigmine reversal of NMB, compared to sugammadex. It is still unclear whether the adequate use of neostigmine guarantees normal respiratory muscle function after NMB. In this study, we wanted to assess the effect of commonly used degrees of NMB and their possible reversal strategies on respiratory muscle activity after the return of normal neuromuscular transmission. METHODS This is a randomized, controlled, parallel-group, single-centre, double-blind study in patients scheduled for intracranial surgery at a tertiary academic hospital in Belgium. All participants received target controlled propofol/remifentanil anesthesia and were randomized into one of five groups, receiving either a shallow NMB with no reversal (shallow/saline), a shallow NMB with sugammadex reversal (shallow/sugammadex), a moderate NMB with neostigmine reversal (moderate/neostigmine), a moderate NMB with sugammadex reversal (moderate/sugammadex), or a deep NMB with sugammadex reversal (deep/sugammadex). Primary and secondary outcome parameters were diaphragm and intercostal electromyographic (EMG) activity at the moment of resumed spontaneous breathing activity, defined as a maximal interval of 10 min after the first spontaneous breath. RESULTS For the five groups, a total of 55 patients could be included in the final analysis. Median time of spontaneous breathing analyzed was 5 min (IQR 3-9.5 min). Both the moderate/sugammadex and the moderate/neostigmine groups had lower levels of diaphragm EMG compared to the shallow/sugammadex group. The moderate/neostigmine group had lower levels of intercostal EMG activity compared to the shallow/saline group. CONCLUSIONS In this study, the depth of neuromuscular blockade and type of reversal strategy impacts respiratory muscle activity at the moment of resumed spontaneous breathing and recovery of neuromuscular blockade. Both groups that received moderate NMB had lower levels of diaphragm EMG, compared to the shallow NMB group with sugammadex reversal. Compared to the shallow NMB group with no reversal, the moderate NMB with neostigmine reversal group had lower intercostal EMG activity. TRIAL REGISTRATION Clinicaltrials.gov NCT01962298 on October 9, 2013 and EudraCT 2013-001926-25 on October 10, 2013.",2019,"The moderate/neostigmine group had lower levels of intercostal EMG activity compared to the shallow/saline group. ","['October 9, 2013 and EudraCT 2013-001926-25 on October 10, 2013', 'patients scheduled for intracranial surgery at a tertiary academic hospital in Belgium']","['shallow NMB', 'neostigmine- or sugammadex', 'NMB', 'shallow NMB with no reversal (shallow/saline), a shallow NMB with sugammadex reversal (shallow/sugammadex), a moderate NMB with neostigmine reversal (moderate/neostigmine), a moderate NMB with sugammadex reversal (moderate/sugammadex), or a deep NMB with sugammadex reversal (deep/sugammadex', 'propofol/remifentanil anesthesia', 'neostigmine']","['intercostal EMG activity', 'Median time of spontaneous breathing', 'diaphragm and intercostal electromyographic (EMG) activity at the moment of resumed spontaneous breathing activity, defined as a maximal interval of 10\u2009min after the first spontaneous breath', 'levels of diaphragm EMG', 'diaphragmatic activity', 'diaphragm EMG', 'respiratory muscle activity']","[{'cui': 'C0030703', 'cui_str': 'Schedules, Patient'}, {'cui': 'C0524466', 'cui_str': 'Intracranial (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0205372', 'cui_str': 'Tertiary (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0004950', 'cui_str': 'Belgium'}]","[{'cui': 'C0027679', 'cui_str': 'Neostigmine'}, {'cui': 'C1700695', 'cui_str': 'Sugammadex'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}]","[{'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous (qualifier value)'}, {'cui': 'C0035203', 'cui_str': 'Breathing'}, {'cui': 'C0011980', 'cui_str': 'Respiratory Diaphragm'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0225386', 'cui_str': 'Breath (substance)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0035231', 'cui_str': 'Ventilatory Muscles'}]",,0.300353,"The moderate/neostigmine group had lower levels of intercostal EMG activity compared to the shallow/saline group. ","[{'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Schepens', 'Affiliation': 'Department of Critical Care Medicine, Antwerp University Hospital, Edegem, Belgium. tom.schepens@uza.be.'}, {'ForeName': 'Koen', 'Initials': 'K', 'LastName': 'Janssens', 'Affiliation': 'Department of Neurosurgery, Antwerp University Hospital, Edegem, Belgium.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Maes', 'Affiliation': 'Department of Anesthesia, Antwerp University Hospital, Edegem, Belgium.'}, {'ForeName': 'Davina', 'Initials': 'D', 'LastName': 'Wildemeersch', 'Affiliation': 'Department of Anesthesia, Antwerp University Hospital, Edegem, Belgium.'}, {'ForeName': 'Jurryt', 'Initials': 'J', 'LastName': 'Vellinga', 'Affiliation': 'MedMen, Groningen, The Netherlands.'}, {'ForeName': 'Philippe G', 'Initials': 'PG', 'LastName': 'Jorens', 'Affiliation': 'Department of Critical Care Medicine, Antwerp University Hospital, Edegem, Belgium.'}, {'ForeName': 'Vera', 'Initials': 'V', 'LastName': 'Saldien', 'Affiliation': 'Department of Anesthesia, Antwerp University Hospital, Edegem, Belgium.'}]",BMC anesthesiology,['10.1186/s12871-019-0863-y'] 828,30547421,Randomized-controlled trial of parent-led exposure to anesthetic mask to prevent child preoperative anxiety.,"PURPOSE To examine the efficacy of parent-directed anesthetic mask exposure and shaping practice to prevent child preoperative anxiety, with a specific focus on timing of exposure. METHODS This randomized-controlled trial included 110 children ages four to seven years undergoing day surgery dental procedures and their parents. Families were randomly assigned to one of three groups: 1) parent-directed mask exposure/shaping practice at least three times in the week prior to surgery (Group 1); 2) parent-directed mask exposure/shaping practice at least once on the day of surgery (Group 2); 3) no exposure prior to induction (Group 3). Child anxiety was observer-rated using the modified Yale Preoperative Anxiety Scale during the day surgery experience, and induction compliance was observer-rated using the Induction Compliance Checklist. RESULTS Results demonstrated significant differences in observer-rated child anxiety at anesthetic induction across groups. Group 2 demonstrated significantly lower observer-rated anxiety than Group 3 with a medium effect, F(1, 71) = 4.524, P = 0.04, η p 2 = 0.06. A significant interaction was observed between these two groups over time (i.e., admission to anesthesia induction), F(1, 71) = 4.365, P = 0.04, η p 2 = 0.06 (i.e., small to medium effect). Group 2 demonstrated the best anesthesia induction compliance (i.e., significantly lower scores than Group 3, P = 0.04). CONCLUSION Timing of the delivery of mask exposure (i.e., on the day of surgery) to address child preoperative anxiety and induction compliance in the day surgery setting may be an important consideration. The current results inform the integration of this simple, effective strategy into practice.",2019,"Group 2 demonstrated the best anesthesia induction compliance (i.e., significantly lower scores than Group 3, P = 0.04). ",['110 children ages four to seven years undergoing day surgery dental procedures and their parents'],"['parent-directed anesthetic mask exposure and shaping practice', 'parent-directed mask exposure/shaping practice at least three times in the week prior to surgery (Group 1); 2) parent-directed mask exposure/shaping practice at least once on the day of surgery (Group 2); 3) no exposure prior to induction', 'parent-led exposure to anesthetic mask']","['anesthesia induction compliance', 'observer-rated child anxiety', 'Child anxiety', 'observer-rated anxiety', 'child preoperative anxiety']","[{'cui': 'C4517536', 'cui_str': '110 (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0282046', 'cui_str': 'Surgery, Day'}, {'cui': 'C4522313', 'cui_str': 'Dental (intended site)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}]","[{'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C0002930', 'cui_str': 'Anesthesiology'}, {'cui': 'C0024861', 'cui_str': 'Masks'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0522512', 'cui_str': 'With shape (attribute)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0441861', 'cui_str': 'Group 1 (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0441865', 'cui_str': 'Group 2 (qualifier value)'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0332157', 'cui_str': 'Exposure to (contextual qualifier) (qualifier value)'}]","[{'cui': 'C0473960', 'cui_str': 'Induction of general anesthesia (procedure)'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}]",110.0,0.0231577,"Group 2 demonstrated the best anesthesia induction compliance (i.e., significantly lower scores than Group 3, P = 0.04). ","[{'ForeName': 'Kirstie L', 'Initials': 'KL', 'LastName': 'Walker', 'Affiliation': 'Department of Psychology, University of Regina, 3737 Wascana Parkway, Regina, SK, S4S 0A2, Canada. walke22k@uregina.ca.'}, {'ForeName': 'Kristi D', 'Initials': 'KD', 'LastName': 'Wright', 'Affiliation': 'Department of Psychology, University of Regina, 3737 Wascana Parkway, Regina, SK, S4S 0A2, Canada.'}, {'ForeName': 'Mateen', 'Initials': 'M', 'LastName': 'Raazi', 'Affiliation': 'Department of Anesthesiology, Perioperative Medicine and Pain Management, College of Medicine, University of Saskatchewan, Saskatoon, SK, Canada.'}]",Canadian journal of anaesthesia = Journal canadien d'anesthesie,['10.1007/s12630-018-01274-8'] 829,31942927,Inulin-type fructan intervention restricts the increase in gut microbiome-generated indole in patients with peritoneal dialysis: a randomized crossover study.,"BACKGROUND Indoxyl sulfate (IS) and p-cresyl sulfate (pCS), 2 important protein-bound uremic toxins, are independent risk factors for cardiovascular disease in patients with end-stage renal disease. Indole and p-cresol are gut microbiome-generated precursors of IS and pCS. OBJECTIVE The aim of the present study was to determine whether inulin-type fructans (ITFs) reduce the production of indole and p-cresol by altering their producing bacteria in patients with peritoneal dialysis. METHODS Patients receiving peritoneal dialysis for >3 mo without diabetes and not using antibiotics were recruited to a randomized, double-blind, placebo-controlled, crossover trial of ITF intervention over 36 wk (12-wk washout). The primary outcomes were gut microbiome, fecal indole and p-cresol, indole-producing bacteria, p-cresol-producing bacteria, and serum IS and pCS. The secondary outcomes were fecal pH, 24-h urine, and dialysis removal of IS and pCS. RESULTS Of 21 individuals randomly assigned, 15 completed the study. The daily nutrient intakes, including protein, tryptophan, and tyrosine, were isostatic during the prebiotic, washout, and placebo intervention. There were no baseline differences in the outcomes of interest between treatments. For fecal indole, its concentrations did not change significantly in either treatment. However, there was a trend toward the treatment-by-time effect (P = 0.052), with a quantitative reduction in the ITF treatment and an increase in the control. The difference in the changes between the 2 treatments was significant (-10.07 ± 7.48 μg/g vs +13.35 ± 7.66 μg/g; P = 0.040). Similar to Bacteroides thetaiotaomicron, there was a difference over time between the 2 treatments, with a significant treatment and time interaction effect (P = 0.047). There were no treatment, time, or interaction effects for fecal p-cresol, serum IS and pCS, 24-h urine, and dialysis removal of IS and pCS. CONCLUSIONS Our results suggested that ITFs restricted the increase in gut microbiome-generated indole in patients with peritoneal dialysis. This trial was registered at http://www.chictr.org.cn/showproj.aspx?proj=21228 as ChiCTR-INR-17013739.",2020,"There were no treatment, time, or interaction effects for fecal p-cresol, serum IS and pCS, 24-h urine, and dialysis removal of IS and pCS. ","['Patients receiving peritoneal dialysis for >3 mo without diabetes and not using antibiotics', 'patients with peritoneal dialysis', 'patients with end-stage renal disease', '21 individuals randomly assigned']","['placebo', 'inulin-type fructans (ITFs', 'ITF intervention', 'Inulin-type fructan intervention', 'placebo intervention', 'Indoxyl sulfate (IS) and p-cresyl sulfate (pCS']","['gut microbiome, fecal indole and p-cresol, indole-producing bacteria, p-cresol-producing bacteria, and serum IS and pCS', 'time, or interaction effects for fecal p-cresol, serum IS and pCS, 24-h\xa0urine, and dialysis removal of IS and pCS', 'daily nutrient intakes, including protein, tryptophan, and tyrosine', 'fecal pH, 24-h\xa0urine, and dialysis removal of IS and pCS', 'time interaction effect']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0031139', 'cui_str': 'Peritoneal Dialysis'}, {'cui': 'C0445107', 'cui_str': 'Not used (qualifier value)'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C0022661', 'cui_str': 'End-Stage Kidney Disease'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0021936', 'cui_str': 'Inulin'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0016743', 'cui_str': 'Levans'}, {'cui': 'C0021210', 'cui_str': 'Indoxyl Sulfate'}, {'cui': 'C0038720', 'cui_str': 'Sulfates, Inorganic'}]","[{'cui': 'C4018878', 'cui_str': 'Gastrointestinal Microbial Community'}, {'cui': 'C0021242', 'cui_str': 'Indoles'}, {'cui': 'C0048212', 'cui_str': 'para-cresol'}, {'cui': 'C1510439', 'cui_str': 'bacteria'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0042037'}, {'cui': 'C4551529', 'cui_str': 'Renal Dialysis'}, {'cui': 'C0015252', 'cui_str': 'Removal - action (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0006777', 'cui_str': 'Caloric Intake'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0041249', 'cui_str': 'L-tryptophan'}, {'cui': 'C0041485', 'cui_str': 'L-tyrosine'}, {'cui': 'C2711455', 'cui_str': 'pH of stool'}]",15.0,0.121454,"There were no treatment, time, or interaction effects for fecal p-cresol, serum IS and pCS, 24-h urine, and dialysis removal of IS and pCS. ","[{'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Department of Nutrition and Food Hygiene, Hubei Key Laboratory of Food Nutrition and Safety, School of Public Health, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Qingqing', 'Initials': 'Q', 'LastName': 'Xiong', 'Affiliation': 'Department of Nutrition and Food Hygiene, Hubei Key Laboratory of Food Nutrition and Safety, School of Public Health, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Zhao', 'Affiliation': 'Department of Nutrition and Food Hygiene, Hubei Key Laboratory of Food Nutrition and Safety, School of Public Health, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Xuechun', 'Initials': 'X', 'LastName': 'Lin', 'Affiliation': 'Department of Nutrition and Food Hygiene, Hubei Key Laboratory of Food Nutrition and Safety, School of Public Health, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Shuiqin', 'Initials': 'S', 'LastName': 'He', 'Affiliation': 'Department of Nutrition and Food Hygiene, Hubei Key Laboratory of Food Nutrition and Safety, School of Public Health, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Nannan', 'Initials': 'N', 'LastName': 'Wu', 'Affiliation': 'Department of Nutrition and Food Hygiene, Hubei Key Laboratory of Food Nutrition and Safety, School of Public Health, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Yao', 'Affiliation': 'Department of Clinical Nutrition, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Wangqun', 'Initials': 'W', 'LastName': 'Liang', 'Affiliation': 'Division of Nephrology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Xuezhi', 'Initials': 'X', 'LastName': 'Zuo', 'Affiliation': 'Department of Clinical Nutrition, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Chenjiang', 'Initials': 'C', 'LastName': 'Ying', 'Affiliation': 'Department of Nutrition and Food Hygiene, Hubei Key Laboratory of Food Nutrition and Safety, School of Public Health, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}]",The American journal of clinical nutrition,['10.1093/ajcn/nqz337'] 830,29913280,Emricasan Improves Liver Function in Patients With Cirrhosis and High Model for End-Stage Liver Disease Scores Compared With Placebo.,"BACKGROUND & AIMS Caspase-mediated apoptosis and inflammation contribute to progression of liver disease. Emricasan is a pan-caspase inhibitor that reduced serum markers of apoptosis and liver inflammation in patients with hepatitis C and non-alcoholic steatohepatitis (NASH). METHODS We performed a multicenter study of 86 patients with cirrhosis (Child-Pugh class A or B; mean score, 6.9; 38% with alcohol-associated cirrhosis, 29% with HCV-associated cirrhosis, and 23% with NASH) and model for end-stage liver disease (MELD) scores of 11-18 (mean, 12.8). Patients were randomly assigned to groups given placebo (N = 42) or Emricasan (25 mg, N = 44), twice daily for 3 months; subjects then received open-label Emricasan (25 mg) twice-daily for 3 months. The primary endpoint was the change from baseline in serum levels of cleaved keratin 18 (CK-18) at month 3. RESULTS Seventy-four patients completed the 3-month study period (40 given Emricasan and 34 given placebo); 69 patients received open-label Emricasan for 3 months afterward. At the 3-month timepoint, Emricasan significantly reduced mean MELD (P = .003) and Child-Pugh (P = .003) scores in subjects with high MELD scores (15 or more), compared with placebo, with significant reductions in INR (95% CI, -0.2882 to -0.0866) and total bilirubin (95% CI, -1.5069 to -0.0823) vs placebo. There were no significant differences between Emricasan and placebo groups in mean MELD (P = .466) or Child-Pugh (P = .124) scores overall at 3 months compared to placebo. Of patients with high MELD scores, 6/9 given Emricasan (67%) had a reduction of 2 points or more at month 3, compared with 2/10 given placebo (20%). Serum levels of full-length CK-18 (P = .02) and caspase 3/7 (P < .001), but not cleaved CK-18 (P = .092), decreased significantly at 3 months in the Emricasan vs placebo group. Emricasan was well tolerated, and adverse events were balanced between groups. Emricasan's effects were generally maintained or increased after 6 months of treatment. CONCLUSIONS In a randomized trial of patients with cirrhosis, we found 3 months treatment with Emricasan to improve liver function, compared with placebo, reducing MELD and Child-Pugh scores, INR, and total bilirubin in patients with MELD scores ≥15. ClinicalTrials.gov no: NCT02230670.",2019,"Serum levels of full-length CK-18 (P = .02) and caspase 3/7 (P < .001), but not cleaved CK-18 (P = .092), decreased significantly at 3 months in the Emricasan vs placebo group.","['patients with MELD scores ≥15', 'patients with hepatitis C and non-alcoholic steatohepatitis (NASH', '86 patients with cirrhosis (Child', 'patients with cirrhosis']","['Placebo', 'Emricasan', 'placebo', 'open-label Emricasan']","['mean MELD', 'INR', 'Child-Pugh', 'tolerated, and adverse events', 'liver function', 'Serum levels of full-length CK-18', 'Liver Function', 'total bilirubin', 'change from baseline in serum levels of cleaved keratin 18 (CK-18', 'MELD and Child-Pugh scores, INR, and total bilirubin']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4048785', 'cui_str': 'MELD score'}, {'cui': 'C0019196', 'cui_str': 'Parenterally-Transmitted Non-A, Non-B Hepatitis'}, {'cui': 'C3241937', 'cui_str': 'Nonalcoholic Steatohepatitis'}, {'cui': 'C1623038', 'cui_str': 'Cirrhosis'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2699871'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0525032', 'cui_str': 'INR'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0232741', 'cui_str': 'Liver function (observable entity)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0201913', 'cui_str': 'Bilirubin, total measurement (procedure)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0205242', 'cui_str': 'Cleaved (qualifier value)'}, {'cui': 'C0010805', 'cui_str': 'Cytokeratin 18'}, {'cui': 'C2347612', 'cui_str': 'Child-Pugh score (assessment scale)'}]",86.0,0.381512,"Serum levels of full-length CK-18 (P = .02) and caspase 3/7 (P < .001), but not cleaved CK-18 (P = .092), decreased significantly at 3 months in the Emricasan vs placebo group.","[{'ForeName': 'Catherine T', 'Initials': 'CT', 'LastName': 'Frenette', 'Affiliation': 'Department of Organ Transplant, Scripps Clinic, La Jolla, California. Electronic address: Frenette.Catherine@scrippshealth.org.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Morelli', 'Affiliation': 'Department of Medicine, University of Florida, Gainesville, Florida.'}, {'ForeName': 'Mitchell L', 'Initials': 'ML', 'LastName': 'Shiffman', 'Affiliation': 'Liver Institute of Virginia, Richmond, Virginia.'}, {'ForeName': 'R Todd', 'Initials': 'RT', 'LastName': 'Frederick', 'Affiliation': 'Division of Hepatology, Department of Transplantation, California Pacific Medical Center, San Francisco, California.'}, {'ForeName': 'Raymond A', 'Initials': 'RA', 'LastName': 'Rubin', 'Affiliation': 'Piedmont Transplant Institute, Mercer University School of Medicine, Atlanta, Georgia.'}, {'ForeName': 'Michael B', 'Initials': 'MB', 'LastName': 'Fallon', 'Affiliation': 'Department of Medicine, University of Arizona, Phoenix, Arizona.'}, {'ForeName': 'Jason T', 'Initials': 'JT', 'LastName': 'Cheng', 'Affiliation': 'Loma Linda University Medical Center, Loma Linda, California.'}, {'ForeName': 'Matt', 'Initials': 'M', 'LastName': 'Cave', 'Affiliation': 'Division of Gastroenterology, Hepatology and Nutrition, University of Louisville, Louisville, Kentucky.'}, {'ForeName': 'Saira A', 'Initials': 'SA', 'LastName': 'Khaderi', 'Affiliation': 'Division of Abdominal Transplantation, Baylor College of Medicine, Houston, Texas.'}, {'ForeName': 'Omar', 'Initials': 'O', 'LastName': 'Massoud', 'Affiliation': 'Division of Gastroenterology and Hepatology, University of Alabama-Birmingham, Birmingham, Alabama.'}, {'ForeName': 'Nikolaos', 'Initials': 'N', 'LastName': 'Pyrsopoulos', 'Affiliation': 'Division of Gastroenterology and Hepatology, Rutgers New Jersey Medical School, Newark, New Jersey.'}, {'ForeName': 'James S', 'Initials': 'JS', 'LastName': 'Park', 'Affiliation': 'Division of Gastroenterology and Hepatology, New York University Langone Medical Center, New York, New York.'}, {'ForeName': 'James M', 'Initials': 'JM', 'LastName': 'Robinson', 'Affiliation': 'Conatus Pharmaceuticals Inc, San Diego, California.'}, {'ForeName': 'Mason', 'Initials': 'M', 'LastName': 'Yamashita', 'Affiliation': 'Conatus Pharmaceuticals Inc, San Diego, California.'}, {'ForeName': 'Alfred P', 'Initials': 'AP', 'LastName': 'Spada', 'Affiliation': 'Conatus Pharmaceuticals Inc, San Diego, California.'}, {'ForeName': 'Jean L', 'Initials': 'JL', 'LastName': 'Chan', 'Affiliation': 'Conatus Pharmaceuticals Inc, San Diego, California.'}, {'ForeName': 'David T', 'Initials': 'DT', 'LastName': 'Hagerty', 'Affiliation': 'Conatus Pharmaceuticals Inc, San Diego, California.'}]",Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association,['10.1016/j.cgh.2018.06.012'] 831,31155160,Implementation of tunneled versus not tunneled peripherally inserted central catheters.,"Tunneled peripherally inserted central catheters (PICCs) offer several advantages such as an exit site at the green zone no matter where the puncture point is and a long subcutaneous route, which is considered a shield against infections and provides comfort to the patient. Clinicians could choose the proper exact exit site so as to avoid blood leakage from the exit point. The aim of the study was to assess the value of the tunneled PICCs versus normal PICCs with no long subcutaneous route. Sixty patients were randomly divided into two groups and underwent a PICC placement procedure between August 2014 and November 2014 and were then observed until February 2015. Thirty of them (group A) underwent a PICC placement procedure, after proper ultrasound scan and under local anesthesia, of the veins of the upper limb, internal jugular and axillary veins. The mean (±standard deviation) age of patients was 54.8 ± 9.2 years (range, 18-80 years). The primary success rate was 100% for all patients in both the groups. The procedure was not painful for the patients. In group A, after 3 months of surveillance, 7 devices were removed because the patients' therapy came to an end, and only in one incident, the catheter was removed due to soft tissue infection. Tunneled PICCs seem to be a safe option and an easy alternative to perform in contrast to placement without a tunnel. It is an easy, cheap procedure that allows us to catheterize the vein with a larger caliber and create an exit point at any preselected point on the upper limb.",2019,Tunneled PICCs seem to be a safe option and an easy alternative to perform in contrast to placement without a tunnel.,"['Sixty patients', 'between August 2014 and November 2014 and were then observed until February 2015']","['tunneled versus not tunneled peripherally inserted central catheters', 'PICC placement procedure, after proper ultrasound scan and under local anesthesia, of the veins of the upper limb, internal jugular and axillary veins', 'PICC placement procedure', 'Tunneled peripherally inserted central catheters (PICCs', 'tunneled PICCs versus normal PICCs with no long subcutaneous route']",['primary success rate'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3875135', 'cui_str': 'Observes (attribute)'}]","[{'cui': 'C3854183', 'cui_str': 'Tunneler (physical object)'}, {'cui': 'C0179740', 'cui_str': 'Long line'}, {'cui': 'C2049629', 'cui_str': 'PICC Placement'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0041618', 'cui_str': 'Echotomography'}, {'cui': 'C1720162', 'cui_str': 'Under local anesthesia'}, {'cui': 'C0042449', 'cui_str': 'Veins'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0205102', 'cui_str': 'Internal (qualifier value)'}, {'cui': 'C0004456', 'cui_str': 'Axillary Vein'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C1522438', 'cui_str': 'SC use'}]","[{'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}]",60.0,0.0181809,Tunneled PICCs seem to be a safe option and an easy alternative to perform in contrast to placement without a tunnel.,"[{'ForeName': 'Kapritsou', 'Initials': 'K', 'LastName': 'Maria', 'Affiliation': 'Chief Nurse of PACU, Hellenic Anticancer Institute, ""Saint Savvas"" Hospital, Day Care Surgery Clinic ""N. Kourkoulos"", Athens, Greece.'}, {'ForeName': 'Katsoulas', 'Initials': 'K', 'LastName': 'Theodoros', 'Affiliation': 'Assistance Professor, National and Kapodistrian University of Athens, Department of Nursing, Greece.'}, {'ForeName': 'Bastaki', 'Initials': 'B', 'LastName': 'Maria', 'Affiliation': 'General Hospital of Nikaias, Piraeus, Greece.'}, {'ForeName': 'Kiekkas', 'Initials': 'K', 'LastName': 'Panagiotis', 'Affiliation': 'Department of Anesthesiology, General University Hospital of Patras, Patras, Greece.'}, {'ForeName': 'Stafylarakis', 'Initials': 'S', 'LastName': 'Emmanouil', 'Affiliation': 'NHS England, UCL, London, United Kingdom.'}, {'ForeName': 'Konstantinou A', 'Initials': 'KA', 'LastName': 'Evangelos', 'Affiliation': 'Department of Nursing, Professor of Nurse Anesthesiology and Vascular Access, National and Kapodistrian University of Athens, Athens, Greece. Electronic address: ekonstan30@yahoo.com.'}]",Journal of vascular nursing : official publication of the Society for Peripheral Vascular Nursing,['10.1016/j.jvn.2018.11.007'] 832,31684867,The effect of intraoperative lidocaine versus esmolol infusion on postoperative analgesia in laparoscopic cholecystectomy: a randomized clinical trial.,"BACKGROUND As a part of multimodal analgesia for laparoscopic cholecystectomy, both intraoperative lidocaine and esmolol facilitate postoperative analgesia. Our objective was to compare these two emerging strategies that challenge the use of intraoperative opioids. We aimed to assess if intraoperative esmolol infusion is not inferior to lidocaine infusion for opioid consumption after laparoscopic cholecystectomy. METHODS In this prospective, randomized, double-blind, non-inferiority clinical trial, 90 female patients scheduled for elective laparoscopic cholecystectomy received either intravenous (IV) lidocaine bolus 1.5 mg/kg at induction followed by an infusion (1.5 mg/ kg/h) or IV bolus of esmolol 0.5 mg/kg at induction followed by an infusion (5-15 μg/kg/min) till the end of surgery. Remaining aspect of anesthesia followed a standard protocol apart from no intraoperative opioid supplementation. Postoperatively, patients received either morphine or tramadol IV to maintain visual analogue scale (VAS) scores ≤3. The primary outcome was opioid consumption (in morphine equivalents) during the first 24 postoperative hours. Pain and sedation scores, time to first perception of pain and void, and occurrence of nausea/vomiting were secondary outcomes measured up to 24 h postoperatively. RESULTS Two patients in each group were excluded from the analysis. The postoperative median (IQR) morphine equivalent consumption in patients receiving esmolol was 1 (0-1.5) mg compared to 1.5 (1-2) mg in lidocaine group (p = 0.27). The median pain scores at various time points were similar between the two groups (p > 0.05). More patients receiving lidocaine were sedated in the post-anesthesia care unit (PACU) than those receiving esmolol (p < 0.05); however, no difference was detected later. CONCLUSION Infusion of esmolol is not inferior to lidocaine in terms of opioid requirement and pain severity in the first 24 h after surgery. Patients receiving lidocaine were more sedated during their stay in PACU than those receiving esmolol. TRIAL REGISTRATION ClinicalTrials.gov - NCT02327923. Date of registration: December 31, 2014.",2019,"We aimed to assess if intraoperative esmolol infusion is not inferior to lidocaine infusion for opioid consumption after laparoscopic cholecystectomy. ","['90 female patients scheduled for', 'laparoscopic cholecystectomy']","['lidocaine', 'intraoperative esmolol', 'esmolol infusion', 'elective laparoscopic cholecystectomy received either intravenous (IV) lidocaine bolus 1.5\u2009mg/kg at induction followed by an infusion', 'morphine or tramadol IV', 'esmolol 0.5\u2009mg/kg at induction followed by an infusion', 'intraoperative lidocaine', 'esmolol', 'lidocaine and esmolol']","['opioid requirement and pain severity', 'opioid consumption (in morphine equivalents', 'Pain and sedation scores, time to first perception of pain and void, and occurrence of nausea/vomiting', 'postoperative median (IQR) morphine equivalent consumption', 'median pain scores']","[{'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0030703', 'cui_str': 'Schedules, Patient'}, {'cui': 'C0162522', 'cui_str': 'Cholecystectomy, Celioscopic'}]","[{'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0116569', 'cui_str': 'esmolol'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0162522', 'cui_str': 'Cholecystectomy, Celioscopic'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0040610', 'cui_str': 'Tramadol'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}]","[{'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}]",90.0,0.525628,"We aimed to assess if intraoperative esmolol infusion is not inferior to lidocaine infusion for opioid consumption after laparoscopic cholecystectomy. ","[{'ForeName': 'Joshan Lal', 'Initials': 'JL', 'LastName': 'Bajracharya', 'Affiliation': 'Department of Anesthesiology & Critical Care, Mechi Zonal Hospital, Bhadrapur, Nepal.'}, {'ForeName': 'Asish', 'Initials': 'A', 'LastName': 'Subedi', 'Affiliation': 'Department of Anesthesiology & Critical Care Medicine, BP Koirala Institute of Health Sciences, BPKIHS, Dharan, Nepal. ashish.subedi@bpkihs.edu.'}, {'ForeName': 'Krishna', 'Initials': 'K', 'LastName': 'Pokharel', 'Affiliation': 'Department of Anesthesiology & Critical Care Medicine, BPKIHS, Dharan, Nepal.'}, {'ForeName': 'Balkrishna', 'Initials': 'B', 'LastName': 'Bhattarai', 'Affiliation': 'Department of Anesthesiology & Critical Care Medicine, BPKIHS, Dharan, Nepal.'}]",BMC anesthesiology,['10.1186/s12871-019-0874-8'] 833,31690285,The midline approach for endotracheal intubation using GlideScope video laryngoscopy could provide better glottis exposure in adults: a randomized controlled trial.,"BACKGROUND Previous studies have demonstrated that the common laryngoscopic approach (right-sided) and midline approach are both used for endotracheal intubation by direct laryngoscopy. Although the midline approach is commonly recommended for video laryngoscopy (VL) in the clinic, there is a lack of published evidences to support this practice. This study aimed to evaluate the effects of different video laryngoscopic approaches on intubation. METHODS Two hundred sixty-two patients aged 18 years who underwent elective surgery under general anaesthesia and required endotracheal intubation were included in the present prospective, randomized, controlled study. The participants were randomly and equally allocated to the right approach (Group R) or midline approach (Group M). All the intubations were conducted by experienced anaesthetists using GlideScope video laryngoscopy. The primary outcomes were Cormack-Lehane laryngoscopic views (CLVs) and first-pass success (FPS) rates. The secondary outcomes were the time to glottis exposure, time to tracheal intubation, haemodynamic responses and other adverse events. Comparative analysis was performed between the groups. RESULTS Finally, 262 patients completed the study, and all the tracheas were successfully intubated. No significant differences were observed in the patient characteristics and airway assessments (P > 0.05). Compared with Group R, Group M had a better CLV (χ2 = 14.706, P = 0.001) and shorter times to glottis exposure (8.82 ± 2.04 vs 12.38 ± 1.81; t = 14.94; P < 0.001) and tracheal intubation (37.19 ± 5.01 vs 45.23 ± 4.81; t = 13.25; P < 0.001), but no difference was found in the FPS rate (70.2% vs 71.8%; χ2 = 0.074; P = 0.446) and intubation procedure time (29.86 ± 2.56 vs 30.46 ± 2.97, t = 1.75, P = 0.081). Between the groups, the rates of hoarseness or sore throat, minor injury, hypoxemia and changes in SBP and HR showed no significant difference (P > 0.05). CONCLUSION Although the FPS rate did not differ based on the laryngoscopic approach, the midline approach could provide better glottis exposure and shorter times to glottis exposure and intubation. The midline approach should be recommended for teaching in VL-assisted endotracheal intubation. TRIAL REGISTRATION The study was registered on May 18, 2019 in the Chinese Clinical Trial Registry ( ChiCTR1900023252 ).",2019,"Although the FPS rate did not differ based on the laryngoscopic approach, the midline approach could provide better glottis exposure and shorter times to glottis exposure and intubation.","['262 patients completed the study, and all the tracheas were successfully intubated', 'adults', 'Two hundred sixty-two patients aged 18 years who underwent elective surgery under general anaesthesia and required endotracheal intubation']","['video laryngoscopic approaches', 'GlideScope video laryngoscopy', 'right approach (Group R) or midline approach']","['time to glottis exposure, time to tracheal intubation, haemodynamic responses and other adverse events', 'tracheal intubation', 'intubation procedure time', 'rates of hoarseness or sore throat, minor injury, hypoxemia and changes in SBP and HR', 'shorter times to glottis exposure', 'patient characteristics and airway assessments', 'FPS rate', 'Cormack-Lehane laryngoscopic views (CLVs) and first-pass success (FPS) rates']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0040578', 'cui_str': 'Trachea'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C4517835', 'cui_str': '62 (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0206058', 'cui_str': 'Elective Surgical Procedures'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0021932', 'cui_str': 'Intubation, Endotracheal'}]","[{'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0023072', 'cui_str': 'Laryngoscopy'}, {'cui': 'C0205090', 'cui_str': 'Right (qualifier value)'}, {'cui': 'C0441852', 'cui_str': 'Group R (qualifier value)'}, {'cui': 'C0589460', 'cui_str': 'Median approach (qualifier value)'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0017681', 'cui_str': 'Glottis structure (body structure)'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0021932', 'cui_str': 'Intubation, Endotracheal'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0019825', 'cui_str': 'Voice Hoarseness'}, {'cui': 'C0242429', 'cui_str': 'Sore Throat'}, {'cui': 'C0332673', 'cui_str': 'Minor injury (morphologic abnormality)'}, {'cui': 'C0700292', 'cui_str': 'Hypoxemia'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0911267', 'cui_str': 'SBP protein, Papaver rhoeas'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0458827', 'cui_str': 'Airway structure (body structure)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0449911', 'cui_str': 'View (attribute)'}, {'cui': 'C0444693', 'cui_str': 'First pass (qualifier value)'}]",262.0,0.124047,"Although the FPS rate did not differ based on the laryngoscopic approach, the midline approach could provide better glottis exposure and shorter times to glottis exposure and intubation.","[{'ForeName': 'Lianxiang', 'Initials': 'L', 'LastName': 'Jiang', 'Affiliation': 'Department of Anaesthesia, Yijishan Hospital of Wannan Medical College, No. 2, Zheshan West Road, Wuhu City, Anhui Province, China.'}, {'ForeName': 'Shulin', 'Initials': 'S', 'LastName': 'Qiu', 'Affiliation': 'Department of Anaesthesia, Beijing Tiantan Hospital of Capital Medical University, Beijing, China.'}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Zhang', 'Affiliation': 'Department of Anaesthesia, Yijishan Hospital of Wannan Medical College, No. 2, Zheshan West Road, Wuhu City, Anhui Province, China.'}, {'ForeName': 'Weidong', 'Initials': 'W', 'LastName': 'Yao', 'Affiliation': 'Department of Anaesthesia, Yijishan Hospital of Wannan Medical College, No. 2, Zheshan West Road, Wuhu City, Anhui Province, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Chang', 'Affiliation': 'Department of Anaesthesia, Yijishan Hospital of Wannan Medical College, No. 2, Zheshan West Road, Wuhu City, Anhui Province, China.'}, {'ForeName': 'Zeping', 'Initials': 'Z', 'LastName': 'Dai', 'Affiliation': 'Department of Anaesthesia, Yijishan Hospital of Wannan Medical College, No. 2, Zheshan West Road, Wuhu City, Anhui Province, China. zpdai@wnmc.edu.cn.'}]",BMC anesthesiology,['10.1186/s12871-019-0876-6'] 834,31925317,A randomised phase II trial of hydroxychloroquine and imatinib versus imatinib alone for patients with chronic myeloid leukaemia in major cytogenetic response with residual disease.,"In chronic-phase chronic myeloid leukaemia (CP-CML), residual BCR-ABL1+ leukaemia stem cells are responsible for disease persistence despite TKI. Based on in vitro data, CHOICES (CHlorOquine and Imatinib Combination to Eliminate Stem cells) was an international, randomised phase II trial designed to study the safety and efficacy of imatinib (IM) and hydroxychloroquine (HCQ) compared with IM alone in CP-CML patients in major cytogenetic remission with residual disease detectable by qPCR. Sixty-two patients were randomly assigned to either arm. Treatment 'successes' was the primary end point, defined as ≥0.5 log reduction in 12-month qPCR level from trial entry. Selected secondary study end points were 24-month treatment 'successes', molecular response and progression at 12 and 24 months, comparison of IM levels, and achievement of blood HCQ levels >2000 ng/ml. At 12 months, there was no difference in 'success' rate (p = 0.58); MMR was achieved in 80% (IM) vs 92% (IM/HCQ) (p = 0.21). At 24 months, the 'success' rate was 20.8% higher with IM/HCQ (p = 0.059). No patients progressed. Seventeen serious adverse events, including four serious adverse reactions, were reported; diarrhoea occurred more frequently with combination. IM/HCQ is tolerable in CP-CML, with modest improvement in qPCR levels at 12 and 24 months, suggesting autophagy inhibition maybe of clinical value in CP-CML.",2020,"At 12 months, there was no difference in 'success' rate (p = 0.58); MMR was achieved in 80% (IM) vs 92% (IM/HCQ) (p = 0.21).","['2000', 'CP-CML patients in major cytogenetic remission with residual disease detectable by qPCR', 'patients with chronic myeloid leukaemia in major cytogenetic response with residual disease', 'Sixty-two patients']","['hydroxychloroquine and imatinib versus imatinib alone', 'IM/HCQ', 'imatinib (IM) and hydroxychloroquine (HCQ']","['MMR', 'diarrhoea', ""24-month treatment 'successes', molecular response and progression at 12 and 24 months, comparison of IM levels, and achievement of blood HCQ levels"", 'qPCR levels', ""success' rate""]","[{'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C0023473', 'cui_str': 'Leukemia, Granulocytic, Chronic'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0010802', 'cui_str': 'Cytogenetic'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C1609982', 'cui_str': 'Residual (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C4055168', 'cui_str': 'Cytogenetic response'}, {'cui': 'C4517835', 'cui_str': '62 (qualifier value)'}]","[{'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}, {'cui': 'C0935989', 'cui_str': 'imatinib'}]","[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}]",62.0,0.0257648,"At 12 months, there was no difference in 'success' rate (p = 0.58); MMR was achieved in 80% (IM) vs 92% (IM/HCQ) (p = 0.21).","[{'ForeName': 'G A', 'Initials': 'GA', 'LastName': 'Horne', 'Affiliation': ""Paul O'Gorman Leukaemia Research Centre, Institute of Cancer Sciences, University of Glasgow, Glasgow, UK.""}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Stobo', 'Affiliation': 'Cancer Research UK Clinical Trials Unit, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Kelly', 'Affiliation': 'Cancer Research UK Clinical Trials Unit, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Mukhopadhyay', 'Affiliation': ""Paul O'Gorman Leukaemia Research Centre, Institute of Cancer Sciences, University of Glasgow, Glasgow, UK.""}, {'ForeName': 'A L', 'Initials': 'AL', 'LastName': 'Latif', 'Affiliation': ""Paul O'Gorman Leukaemia Research Centre, Institute of Cancer Sciences, University of Glasgow, Glasgow, UK.""}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Dixon-Hughes', 'Affiliation': 'Cancer Research UK Clinical Trials Unit, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'McMahon', 'Affiliation': 'Institute of Cancer Sciences, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Cony-Makhoul', 'Affiliation': 'Haematology department, CH Annecy-Genevois, Pringy, France.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Byrne', 'Affiliation': 'Department of Haematology, Nottingham City Hospital, Nottingham, UK.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Smith', 'Affiliation': ""Department of Haematology, St James's University Hospital, Leeds, UK.""}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Koschmieder', 'Affiliation': 'Department of Medicine (Hematology Oncology, Hemostaseology, and Stem Cell Transplantation), Faculty of Medicine, RWTH Aachen University, Aachen, Germany.'}, {'ForeName': 'T H', 'Initials': 'TH', 'LastName': 'BrÜmmendorf', 'Affiliation': 'Department of Medicine (Hematology Oncology, Hemostaseology, and Stem Cell Transplantation), Faculty of Medicine, RWTH Aachen University, Aachen, Germany.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Schafhausen', 'Affiliation': 'Department of Internal Medicine, University Medical Center Hamburg, Hamburg, Germany.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Gallipoli', 'Affiliation': 'Centre for Haemato-Oncology, Barts Cancer Institute, Queen Mary University of London, London, UK.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Thomson', 'Affiliation': 'Experimental therapeutics, Wolfson Wohl Cancer Research Centre, Institute of Cancer Sciences, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Cong', 'Affiliation': 'Experimental therapeutics, Wolfson Wohl Cancer Research Centre, Institute of Cancer Sciences, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'R E', 'Initials': 'RE', 'LastName': 'Clark', 'Affiliation': 'Molecular and Clinical Cancer Medicine, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Milojkovic', 'Affiliation': 'Department of Haematology, Hammersmith Hospital, London, UK.'}, {'ForeName': 'G V', 'Initials': 'GV', 'LastName': 'Helgason', 'Affiliation': ""Paul O'Gorman Leukaemia Research Centre, Institute of Cancer Sciences, University of Glasgow, Glasgow, UK.""}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Foroni', 'Affiliation': 'Department of Haematology, Imperial College London, London, UK.'}, {'ForeName': 'F E', 'Initials': 'FE', 'LastName': 'Nicolini', 'Affiliation': 'Hématologie Clinique and INSERM U1052, CRCL, Centre Léon Bérard, Lyon, France.'}, {'ForeName': 'T L', 'Initials': 'TL', 'LastName': 'Holyoake', 'Affiliation': ""Paul O'Gorman Leukaemia Research Centre, Institute of Cancer Sciences, University of Glasgow, Glasgow, UK.""}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Copland', 'Affiliation': ""Paul O'Gorman Leukaemia Research Centre, Institute of Cancer Sciences, University of Glasgow, Glasgow, UK. Mhairi.Copland@glasgow.ac.uk.""}]",Leukemia,['10.1038/s41375-019-0700-9'] 835,31944318,Dementia palliative care in the acute psychiatric hospital: A feasibility study.,"PURPOSE We explored the feasibility of a clinical pathway to identify hospitalized patients with dementia who would benefit from a palliative intervention. DESIGN AND METHODS Consecutive geropsychiatric admissions were screened for terminal dementia to be randomized to a palliative consultation vs usual care. FINDINGS A total of 43 of the 188 patients (23%) had dementia; however, dementia stages were severe but not terminal. The pathway was not feasible because of the lack of the target population in the inpatient setting for the intervention. PRACTICE IMPLICATIONS New clinical pathways are needed to identify patients with dementia who would benefit from palliative care.",2020,"A total of 43 of the 188 patients (23%) had dementia; however, dementia stages were severe but not terminal.","['patients with dementia who would benefit from palliative care', 'A total of 43 of the 188 patients (23%) had dementia', 'Dementia palliative care in the acute psychiatric hospital', 'hospitalized patients with dementia who would benefit from a palliative intervention', 'Consecutive geropsychiatric admissions were screened for terminal dementia to be randomized to a']",['palliative consultation vs usual care'],[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0497327', 'cui_str': 'Amentia'}, {'cui': 'C0700049', 'cui_str': 'Palliative care'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0020021', 'cui_str': 'Mental Hospitals'}, {'cui': 'C1285530', 'cui_str': 'Palliative'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}]","[{'cui': 'C1285530', 'cui_str': 'Palliative'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}]",[],188.0,0.0411039,"A total of 43 of the 188 patients (23%) had dementia; however, dementia stages were severe but not terminal.","[{'ForeName': 'Melanie T', 'Initials': 'MT', 'LastName': 'Gentry', 'Affiliation': 'Department of Psychiatry and Psychology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Matthew M', 'Initials': 'MM', 'LastName': 'Clark', 'Affiliation': 'Department of Psychiatry and Psychology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Susan M', 'Initials': 'SM', 'LastName': 'Ryan', 'Affiliation': 'Department of Psychiatry and Psychology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Teresa A', 'Initials': 'TA', 'LastName': 'Rummans', 'Affiliation': 'Department of Psychiatry and Psychology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Maria I', 'Initials': 'MI', 'LastName': 'Lapid', 'Affiliation': 'Department of Psychiatry and Psychology, Mayo Clinic, Rochester, Minnesota.'}]",Perspectives in psychiatric care,['10.1111/ppc.12473'] 836,31790344,"Pembrolizumab As Second-Line Therapy in Patients With Advanced Hepatocellular Carcinoma in KEYNOTE-240: A Randomized, Double-Blind, Phase III Trial.","PURPOSE Pembrolizumab demonstrated antitumor activity and safety in the phase II KEYNOTE-224 trial in previously treated patients with advanced hepatocellular carcinoma (HCC). KEYNOTE-240 evaluated the efficacy and safety of pembrolizumab in this population. PATIENTS AND METHODS This randomized, double-blind, phase III study was conducted at 119 medical centers in 27 countries. Eligible patients with advanced HCC, previously treated with sorafenib, were randomly assigned at a two-to-one ratio to receive pembrolizumab plus best supportive care (BSC) or placebo plus BSC. Primary end points were overall survival (OS) and progression-free survival (PFS; one-sided significance thresholds, P = .0174 [final analysis] and P = .002 [first interim analysis], respectively). Safety was assessed in all patients who received ≥ 1 dose of study drug. RESULTS Between May 31, 2016, and November 23, 2017, 413 patients were randomly assigned. As of January 2, 2019, median follow-up was 13.8 months for pembrolizumab and 10.6 months for placebo. Median OS was 13.9 months (95% CI, 11.6 to 16.0 months) for pembrolizumab versus 10.6 months (95% CI, 8.3 to 13.5 months) for placebo (hazard ratio [HR], 0.781; 95% CI, 0.611 to 0.998; P = .0238). Median PFS for pembrolizumab was 3.0 months (95% CI, 2.8 to 4.1 months) versus 2.8 months (95% CI, 2.5 to 4.1 months) for placebo at the first interim analysis (HR, 0.775; 95% CI, 0.609 to 0.987; P = .0186) and 3.0 months (95% CI, 2.8 to 4.1 months) versus 2.8 months (95% CI, 1.6 to 3.0 months) at final analysis (HR, 0.718; 95% CI, 0.570 to 0.904; P = .0022). Grade 3 or higher adverse events occurred in 147 (52.7%) and 62 patients (46.3%) for pembrolizumab versus placebo; those that were treatment related occurred in 52 (18.6%) and 10 patients (7.5%), respectively. No hepatitis C or B flares were identified. CONCLUSION In this study, OS and PFS did not reach statistical significance per specified criteria. The results are consistent with those of KEYNOTE-224, supporting a favorable risk-to-benefit ratio for pembrolizumab in this population.",2020,"Median OS was 13.9 months (95% CI, 11.6 to 16.0 months) for pembrolizumab versus 10.6 months (95% CI, 8.3 to 13.5 months) for placebo (hazard ratio [HR], 0.781; 95% CI, 0.611 to 0.998; P = .0238).","['Eligible patients with advanced HCC, previously treated with', 'Between May 31, 2016, and November 23, 2017, 413 patients were randomly assigned', '119 medical centers in 27 countries', 'previously treated patients with advanced hepatocellular carcinoma (HCC', 'Patients With Advanced Hepatocellular Carcinoma in KEYNOTE-240']","['Pembrolizumab As Second-Line Therapy', 'sorafenib', 'pembrolizumab', 'placebo', 'pembrolizumab plus best supportive care (BSC) or placebo plus BSC']","['antitumor activity and safety', 'hepatitis C or B flares', 'Safety', 'efficacy and safety', 'Median PFS for pembrolizumab', 'overall survival (OS) and progression-free survival (PFS; one-sided significance thresholds, P = .0174', 'Median OS', 'Grade 3 or higher adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0565990', 'cui_str': 'Medical center (environment)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C2239176', 'cui_str': 'Liver Cell Carcinoma, Adult'}, {'cui': 'C4319600', 'cui_str': '240 (qualifier value)'}]","[{'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1516119', 'cui_str': 'sorafenib'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}]","[{'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0019196', 'cui_str': 'Parenterally-Transmitted Non-A, Non-B Hepatitis'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0449864', 'cui_str': 'Threshold (property) (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",413.0,0.539673,"Median OS was 13.9 months (95% CI, 11.6 to 16.0 months) for pembrolizumab versus 10.6 months (95% CI, 8.3 to 13.5 months) for placebo (hazard ratio [HR], 0.781; 95% CI, 0.611 to 0.998; P = .0238).","[{'ForeName': 'Richard S', 'Initials': 'RS', 'LastName': 'Finn', 'Affiliation': 'University of California, Los Angeles, Los Angeles, CA.'}, {'ForeName': 'Baek-Yeol', 'Initials': 'BY', 'LastName': 'Ryoo', 'Affiliation': 'Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Merle', 'Affiliation': 'Lyon North Hospital, Lyon, France.'}, {'ForeName': 'Masatoshi', 'Initials': 'M', 'LastName': 'Kudo', 'Affiliation': 'Kindai University Faculty of Medicine, Osaka, Japan.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Bouattour', 'Affiliation': 'Beaujon University Hospital, Assistance Publique-Hôpitaux de Paris, Clichy, France.'}, {'ForeName': 'Ho Yeong', 'Initials': 'HY', 'LastName': 'Lim', 'Affiliation': 'Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Valeriy', 'Initials': 'V', 'LastName': 'Breder', 'Affiliation': 'NN Blokhin National Medical Research Center of Oncology, Ministry of Health, Moscow, Russian Federation.'}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Edeline', 'Affiliation': 'Centre Eugène Marquis, Rennes, France.'}, {'ForeName': 'Yee', 'Initials': 'Y', 'LastName': 'Chao', 'Affiliation': 'Taipei Veterans General Hospital, Taipei, Taiwan.'}, {'ForeName': 'Sadahisa', 'Initials': 'S', 'LastName': 'Ogasawara', 'Affiliation': 'Chiba University Graduate School of Medicine, Chiba, Japan.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Yau', 'Affiliation': ""The University at Hong Kong, Hong Kong, People's Republic of China.""}, {'ForeName': 'Marcelo', 'Initials': 'M', 'LastName': 'Garrido', 'Affiliation': 'Pontificia Universidad Catolica de Chile, Santiago, Chile.'}, {'ForeName': 'Stephen L', 'Initials': 'SL', 'LastName': 'Chan', 'Affiliation': ""State Key Laboratory of Translation Oncology, Sir YK Pao Centre for Cancer, The Chinese University of Hong Kong, Hong Kong, People's Republic of China.""}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Knox', 'Affiliation': 'Princess Margaret Cancer Centre and University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Daniele', 'Affiliation': 'Ospedale del Mare, Napoli, Italy.'}, {'ForeName': 'Scot W', 'Initials': 'SW', 'LastName': 'Ebbinghaus', 'Affiliation': 'Merck, Kenilworth, NJ.'}, {'ForeName': 'Erluo', 'Initials': 'E', 'LastName': 'Chen', 'Affiliation': 'Merck, Kenilworth, NJ.'}, {'ForeName': 'Abby B', 'Initials': 'AB', 'LastName': 'Siegel', 'Affiliation': 'Merck, Kenilworth, NJ.'}, {'ForeName': 'Andrew X', 'Initials': 'AX', 'LastName': 'Zhu', 'Affiliation': 'Massachusetts General Hospital Cancer Center and Harvard Medical School, Boston, MA.'}, {'ForeName': 'Ann-Lii', 'Initials': 'AL', 'LastName': 'Cheng', 'Affiliation': 'National Taiwan University Hospital and National Taiwan University Cancer Center, Taipei, Taiwan.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.01307'] 837,31804876,Treatment of Older Patients With Mantle Cell Lymphoma (MCL): Long-Term Follow-Up of the Randomized European MCL Elderly Trial.,"PURPOSE In an update of the randomized, open-label, phase III European Mantle Cell Lymphoma (MCL) Elderly trial (ClinicalTrials.gov identifier: NCT00209209), published in 2012, we aimed to confirm results on long-term outcome focusing on efficacy and safety of long-term use of rituximab maintenance. PATIENTS AND METHODS Five hundred sixty patients with newly diagnosed MCL underwent a first random assignment between rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) and rituximab, fludarabine, and cyclophosphamide (R-FC) induction, followed by a second random assignment in 316 responders between rituximab and interferon alfa maintenance, to be continued until progression. We compared progression-free survival from the second randomization and overall survival (OS) from the first or second randomizations. RESULTS After a median follow-up time of 7.6 years, the previously described difference in OS between the induction arms persisted (median, 6.4 years after R-CHOP [n = 280] v 3.9 years after R-FC [n = 280]; P = .0054). Patients responding to R-CHOP had median progression-free survival and OS times of 5.4 and 9.8 years, respectively, when randomly assigned to rituximab (n = 87), compared with 1.9 years ( P < .001) and 7.1 years ( P = .0026), respectively, when randomly assigned to interferon alfa (n = 97). In 58% and 32% of patients treated with R-CHOP, rituximab maintenance was still ongoing 2 and 5 years from start of maintenance, respectively. After R-FC, rituximab maintenance was associated with an unexpectedly high cumulative incidence of death in remission (22% at 5 years). Toxicity of rituximab maintenance was low after R-CHOP (grade 3-4 leukopenia or infection < 5%) but more prominent in patients on rituximab maintenance after R-FC, in whom grade 3-4 leukopenia (up to 40%) and infections were frequent (up to 15%). CONCLUSION The excellent results of R-CHOP followed by rituximab maintenance until progression for older patients with MCL persisted in a mature follow-up. Prolongation of rituximab maintenance beyond 2 years is effective and safe.",2020,"Toxicity of rituximab maintenance was low after R-CHOP (grade 3-4 leukopenia or infection < 5%) but more prominent in patients on rituximab maintenance after R-FC, in whom grade 3-4 leukopenia (up to 40%) and infections were frequent (up to 15%). ","['Five hundred sixty patients with newly diagnosed MCL underwent a first random assignment between', 'older patients with MCL', 'Older Patients With Mantle Cell Lymphoma (MCL']","['rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) and rituximab, fludarabine, and cyclophosphamide (R-FC) induction', 'rituximab', 'rituximab maintenance', 'interferon alfa', 'rituximab and interferon alfa maintenance']","['leukopenia', 'efficacy and safety', 'median progression-free survival and OS times', 'overall survival (OS', 'OS', 'Toxicity of rituximab maintenance', 'progression-free survival']","[{'cui': 'C3816747', 'cui_str': 'Five hundred'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439605', 'cui_str': 'Random (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0334634', 'cui_str': 'Lymphoma, Small-Cell, Centrocytic'}]","[{'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C0042679', 'cui_str': 'Vincristine'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0059985', 'cui_str': 'fludarabine'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C0002199', 'cui_str': 'Interferon, Lymphoblastoid'}]","[{'cui': 'C0750394', 'cui_str': 'Decreased blood leukocyte number (finding)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}]",560.0,0.0628039,"Toxicity of rituximab maintenance was low after R-CHOP (grade 3-4 leukopenia or infection < 5%) but more prominent in patients on rituximab maintenance after R-FC, in whom grade 3-4 leukopenia (up to 40%) and infections were frequent (up to 15%). ","[{'ForeName': 'Hanneke C', 'Initials': 'HC', 'LastName': 'Kluin-Nelemans', 'Affiliation': 'University Medical Center Groningen, University of Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Hoster', 'Affiliation': 'University Hospital Ludwig-Maximilians-University Munich, Munich, Germany.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Hermine', 'Affiliation': 'Hôpital Necker, Institut Imagine, Assistance Publique-Hôpitaux de Paris, University Paris Descartes, Paris, France.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Walewski', 'Affiliation': 'Maria Sklodowska-Curie Institute, Warsaw, Poland.'}, {'ForeName': 'Christian H', 'Initials': 'CH', 'LastName': 'Geisler', 'Affiliation': 'Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Marek', 'Initials': 'M', 'LastName': 'Trneny', 'Affiliation': 'Charles University General Hospital, Prague, Czech Republic.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Stilgenbauer', 'Affiliation': 'University of Ulm, Ulm, Germany.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Kaiser', 'Affiliation': 'VK&K Studien GbR, Landshut, Germany.'}, {'ForeName': 'Jeanette K', 'Initials': 'JK', 'LastName': 'Doorduijn', 'Affiliation': 'Erasmus MC Cancer Institute, Rotterdam, the Netherlands.'}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Salles', 'Affiliation': 'Hospices Civils de Lyon, University of Lyon, Pierre-Benite, France.'}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Szymczyk', 'Affiliation': 'Maria Sklodowska-Curie Institute, Warsaw, Poland.'}, {'ForeName': 'Hervé', 'Initials': 'H', 'LastName': 'Tilly', 'Affiliation': 'Centre Henri Becquerel, Rouen, France.'}, {'ForeName': 'Lothar', 'Initials': 'L', 'LastName': 'Kanz', 'Affiliation': 'University of Tübingen, Tübingen, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Schmidt', 'Affiliation': 'University Hospital Ludwig-Maximilians-University Munich, Munich, Germany.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Feugier', 'Affiliation': 'Center Hospitalier Regional and University Nancy Vandoeuvre les Nancy, Nancy, France.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Thieblemont', 'Affiliation': 'Hôpital Saint Louis, Paris, France.'}, {'ForeName': 'Josée M', 'Initials': 'JM', 'LastName': 'Zijlstra', 'Affiliation': 'Amsterdam University Medical Center, Vrije Universiteit Amsterdam, Cancer Center Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Ribrag', 'Affiliation': 'Institut Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Wolfram', 'Initials': 'W', 'LastName': 'Klapper', 'Affiliation': 'University of Kiel, Kiel, Germany.'}, {'ForeName': 'Christiane', 'Initials': 'C', 'LastName': 'Pott', 'Affiliation': 'University Hospital Schleswig-Holstein Campus Kiel/Christian-Albrechts University Kiel, Kiel, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Unterhalt', 'Affiliation': 'University Hospital Ludwig-Maximilians-University Munich, Munich, Germany.'}, {'ForeName': 'Martin H', 'Initials': 'MH', 'LastName': 'Dreyling', 'Affiliation': 'University Hospital Ludwig-Maximilians-University Munich, Munich, Germany.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.01294'] 838,30930429,Long-Term Treatment With Evolocumab Among Japanese Patients　- Final Report of the OSLER Open-Label Extension Studies.,"BACKGROUND Treatment with evolocumab reduces mean low-density lipoprotein cholesterol (LDL-C) up to 75% and cardiovascular events by 16% in the first year and 25% thereafter. Methods and Results: Japanese patients with hypercholesterolemia enrolled in the parent YUKAWA-1-2 studies could enroll, once eligible, in the OSLER studies (n=556). OSLER re-randomized patients 2:1 to evolocumab plus standard of care (SOC; evolocumab+SOC) or SOC alone for 1 year; after year 1, patients could enter the all-evolocumab+SOC open-label extension of OSLER. Patients received evolocumab+SOC from the 2nd year through up to 5 years. Long-term efficacy and safety, including antidrug antibodies, were evaluated. Of 556 patients, 532 continued to the all-evolocumab+SOC extension: mean (standard deviation [SD]) age 61 (10) years, 39% female. A total of 91% of 532 patients completed the studies. Mean (SD) LDL-C change from parent-study baseline with evolocumab from a mean (SD) baseline of 142.3 (21.3) and 105.0 (31.1) mg/dL in OSLER-1 and OSLER-2, respectively, was maintained through the end of the study: -58.0% (19.1%) at year 5 in OSLER-1, -62.7% (25.6%) at year 3 in OSLER-2. The overall safety profile of the evolocumab+SOC periods was similar to that of the year-1 controlled period. Antidrug antibodies were detected transiently in 3 patients. No neutralizing antibodies were detected. CONCLUSIONS Japanese patients who continued evolocumab+SOC for up to 5 years experienced sustained high LDL-C level reduction. Long-term evolocumab+SOC exposure showed no new safety signals.",2019,The overall safety profile of the evolocumab+SOC periods was similar to that of the year-1 controlled period.,"['Japanese patients with hypercholesterolemia enrolled in the parent YUKAWA-1-2 studies could enroll, once eligible, in the OSLER studies (n=556', '556 patients, 532 continued to the all-evolocumab+SOC extension', 'Japanese patients who continued', 'A total of 91% of 532 patients completed the studies']","['evolocumab plus standard of care (SOC; evolocumab+SOC) or SOC', 'evolocumab', 'evolocumab+SOC', 'Evolocumab']","['neutralizing antibodies', 'mean low-density lipoprotein cholesterol (LDL-C', 'overall safety profile', 'Antidrug antibodies', 'Mean (SD) LDL-C change', 'cardiovascular events', 'sustained high LDL-C level reduction']","[{'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0020443', 'cui_str': 'High Cholesterol Levels'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C4517811', 'cui_str': 'Five hundred and fifty-six'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]","[{'cui': 'C3529352', 'cui_str': 'evolocumab'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C2936643', 'cui_str': 'Standard of Care'}]","[{'cui': 'C1142254', 'cui_str': 'Neutralising antibodies'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0443318', 'cui_str': 'Sustained (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}]",556.0,0.0927723,The overall safety profile of the evolocumab+SOC periods was similar to that of the year-1 controlled period.,"[{'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Hirayama', 'Affiliation': 'Division of Cardiology, Osaka Police Hospital.'}, {'ForeName': 'Shizuya', 'Initials': 'S', 'LastName': 'Yamashita', 'Affiliation': 'Departments of Community Medicine and Cardiovascular Medicine, Graduate School of Medicine, Osaka University.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Ruzza', 'Affiliation': 'Amgen Inc.'}, {'ForeName': 'Hyoe', 'Initials': 'H', 'LastName': 'Inomata', 'Affiliation': 'Amgen Astellas BioPharma K.K.'}, {'ForeName': 'Marcoli', 'Initials': 'M', 'LastName': 'Cyrille', 'Affiliation': 'Amgen Inc.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Lu', 'Affiliation': 'Amgen Inc.'}, {'ForeName': 'Andrew W', 'Initials': 'AW', 'LastName': 'Hamer', 'Affiliation': 'Amgen Inc.'}, {'ForeName': 'Masayuki', 'Initials': 'M', 'LastName': 'Yoshida', 'Affiliation': 'Life Science and Bioethics Research Center, Tokyo Medical and Dental University.'}, {'ForeName': 'Arihiro', 'Initials': 'A', 'LastName': 'Kiyosue', 'Affiliation': 'Department of Cardiovascular Medicine, The University of Tokyo Hospital.'}, {'ForeName': 'Tamio', 'Initials': 'T', 'LastName': 'Teramoto', 'Affiliation': 'Teikyo Academic Research Center, Teikyo University.'}]",Circulation journal : official journal of the Japanese Circulation Society,['10.1253/circj.CJ-19-0139'] 839,31913324,Impact of an integrated mother-preterm infant intervention on birth hospitalization charges.,"OBJECTIVE To examine whether the H-HOPE (Hospital to Home: Optimizing the Preterm Infant's Environment) intervention reduced birth hospitalization charges yielding net savings after adjusting for intervention costs. STUDY DESIGN One hundred and twenty-one mother-preterm infant dyads randomized to H-HOPE or a control group had birth hospitalization data. Neonatal intensive care unit costs were based on billing charges. Linear regression, propensity scoring and regression analyses were used to describe charge differences. RESULTS Mean H-HOPE charges were $10,185 lower than controls (p = 0.012). Propensity score matching showed the largest savings of $14,656 (p = 0.003) for H-HOPE infants, and quantile regression showed a savings of $13,222 at the 75th percentile (p = 0.015) for H-HOPE infants. Cost savings increased as hospital charges increased. The mean intervention cost was $680 per infant. CONCLUSIONS Lower birth hospitalization charges and the net cost savings of H-HOPE infants support implementation of H-HOPE as the standard of care for preterm infants.",2020,"Propensity score matching showed the largest savings of $14,656 (p = 0.003) for H-HOPE infants, and quantile regression showed a savings of $13,222 at the 75th percentile (p = 0.015) for H-HOPE infants.","[""Preterm Infant's Environment"", 'One hundred and twenty-one mother-preterm infant dyads randomized to', 'preterm infants']","['H-HOPE', 'H-HOPE (Hospital to Home', 'integrated mother-preterm infant intervention']","['birth hospitalization data', 'mean intervention cost', 'Mean H-HOPE charges', 'birth hospitalization charges', 'Cost savings']","[{'cui': 'C4048294', 'cui_str': 'Preterm Infant'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}]","[{'cui': 'C0392347', 'cui_str': 'Hope'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C4048294', 'cui_str': 'Preterm Infant'}]","[{'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0392347', 'cui_str': 'Hope'}, {'cui': 'C0007961', 'cui_str': 'Charges'}, {'cui': 'C0085550', 'cui_str': 'Saving, Cost'}]",121.0,0.0351533,"Propensity score matching showed the largest savings of $14,656 (p = 0.003) for H-HOPE infants, and quantile regression showed a savings of $13,222 at the 75th percentile (p = 0.015) for H-HOPE infants.","[{'ForeName': 'Susan C', 'Initials': 'SC', 'LastName': 'Vonderheid', 'Affiliation': 'Department of Women Children, and Family Health Science, College of Nursing, University of Illinois at Chicago, Chicago, IL, USA. vonde@uic.edu.'}, {'ForeName': 'Chang G', 'Initials': 'CG', 'LastName': 'Park', 'Affiliation': 'College of Nursing, University of Illinois at Chicago, Chicago, IL, USA.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Rankin', 'Affiliation': 'Division of Epidemiology and Biostatistics, School of Public Health, University of Illinois at Chicago, Chicago, IL, USA.'}, {'ForeName': 'Kathleen F', 'Initials': 'KF', 'LastName': 'Norr', 'Affiliation': 'Department of Women Children, and Family Health Science, College of Nursing, University of Illinois at Chicago, Chicago, IL, USA.'}, {'ForeName': 'Rosemary', 'Initials': 'R', 'LastName': 'White-Traut', 'Affiliation': 'Department of Women Children, and Family Health Science, College of Nursing, University of Illinois at Chicago, Chicago, IL, USA.'}]",Journal of perinatology : official journal of the California Perinatal Association,['10.1038/s41372-019-0567-7'] 840,31899198,Relationships of self-perceived age with geriatric assessment domains in older adults with cancer.,"OBJECTIVES Older self-perceived age is associated with poor health and higher healthcare utilization in the geriatric population. We evaluated the associations of self-perceived age with geriatric assessment (GA) domain impairments in older adults with cancer. METHODS This was a secondary analysis of baseline data from a GA cluster-randomized trial (URCC 13070; PI: Mohile). We included patients aged ≥70 with incurable stage III/IV solid tumor or lymphoma considering or receiving treatment and had ≥1 GA domain impairment other than polypharmacy. Multivariate analyses were used to evaluate the associations of age difference between chronological and self-perceived age (categorized into ""feeling younger than chronological age"" vs. ""feeling the same or older than their chronological age"") with GA domain impairments. RESULTS We included 533 patients; mean age was 76.6 (SD 5.2). On multivariate analyses, compared to those who felt younger than their chronological age, those who felt the same or older were more likely to have impairments in physical performance [Adjusted Odds Ratio (AOR) 5.42, 95% Confidence Interval (CI) 1.69-17.40)], functional status (AOR 2.31, 95% CI 1.73-3.07), comorbidity (AOR 1.62, 95% CI 1.20-2.19), psychological health (AOR 2.62, 95% CI 1.85-3.73), and nutrition (AOR 1.65, 95% CI 1.20-2.28). They were also more likely to screen positively for polypharmacy (AOR 1.86, 95% CI 1.30-2.65). CONCLUSIONS Older adults with cancer who felt the same or older than their chronological age were more likely to have GA domain impairments. Further studies are needed to better understand the relationships between self-perceived age, aging-related conditions, and outcomes in this population.",2020,"They were also more likely to screen positively for polypharmacy (AOR 1.86, 95% CI 1.30-2.65). ","['533 patients; mean age was 76.6 (SD 5.2', 'patients aged ≥70 with incurable stage III/IV solid tumor or lymphoma considering or receiving treatment and had ≥1 GA domain impairment other than polypharmacy', 'Older adults with cancer who felt the same or older than their chronological age', 'older adults with cancer']",[],"['physical performance [Adjusted Odds Ratio (AOR', 'comorbidity', 'psychological health', 'functional status']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517790', 'cui_str': '5.2 (qualifier value)'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3 (qualifier value)'}, {'cui': 'C0280100', 'cui_str': 'Solid tumour'}, {'cui': 'C0024299', 'cui_str': 'Germinoblastoma'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C2922974', 'cui_str': 'Polymedication'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}]",[],"[{'cui': 'C2607857'}, {'cui': 'C0028873', 'cui_str': 'Risk Ratio'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}]",533.0,0.0707127,"They were also more likely to screen positively for polypharmacy (AOR 1.86, 95% CI 1.30-2.65). ","[{'ForeName': 'Kah Poh', 'Initials': 'KP', 'LastName': 'Loh', 'Affiliation': 'James P Wilmot Cancer Institute, University of Rochester School of Medicine and Dentistry, Rochester, NY, USA. Electronic address: kahpoh_loh@urmc.rochester.edu.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Duberstein', 'Affiliation': 'Department of Health Behavior, Society, and Policy, Rutgers School of Public Health, New Brunswick, NJ, USA. Electronic address: paul_duberstein@rutgers.edu.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Zittel', 'Affiliation': 'James P Wilmot Cancer Institute, University of Rochester School of Medicine and Dentistry, Rochester, NY, USA. Electronic address: jason_zittel@urmc.rochester.edu.'}, {'ForeName': 'Lianlian', 'Initials': 'L', 'LastName': 'Lei', 'Affiliation': 'Department of Public Health Sciences, University of Rochester School of Medicine and Dentistry, Rochester, NY, USA. Electronic address: lianlian_lei@urmc.rochester.edu.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Culakova', 'Affiliation': 'James P Wilmot Cancer Institute, University of Rochester School of Medicine and Dentistry, Rochester, NY, USA. Electronic address: eva_culakova@urmc.rochester.edu.'}, {'ForeName': 'Huiwen', 'Initials': 'H', 'LastName': 'Xu', 'Affiliation': 'James P Wilmot Cancer Institute, University of Rochester School of Medicine and Dentistry, Rochester, NY, USA. Electronic address: huiwen_xu@urmc.rochester.edu.'}, {'ForeName': 'Sandy', 'Initials': 'S', 'LastName': 'Plumb', 'Affiliation': 'James P Wilmot Cancer Institute, University of Rochester School of Medicine and Dentistry, Rochester, NY, USA. Electronic address: sandy_plumb@urmc.rochester.edu.'}, {'ForeName': 'Marie A', 'Initials': 'MA', 'LastName': 'Flannery', 'Affiliation': 'School of Nursing, University of Rochester School of Medicine and Dentistry, Rochester, NY, USA. Electronic address: marie_flannery@urmc.rochester.edu.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Magnuson', 'Affiliation': 'James P Wilmot Cancer Institute, University of Rochester School of Medicine and Dentistry, Rochester, NY, USA. Electronic address: allison_magnuson@urmc.rochester.edu.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Bautista', 'Affiliation': 'James P Wilmot Cancer Institute, University of Rochester School of Medicine and Dentistry, Rochester, NY, USA. Electronic address: javier_bautista@urmc.rochester.edu.'}, {'ForeName': 'Marsha', 'Initials': 'M', 'LastName': 'Wittink', 'Affiliation': 'Department of Psychiatry, University of Rochester School of Medicine and Dentistry, Rochester, NY, USA. Electronic address: marsha_wittink@urmc.rochester.edu.'}, {'ForeName': 'Nikesha', 'Initials': 'N', 'LastName': 'Gilmore', 'Affiliation': 'James P Wilmot Cancer Institute, University of Rochester School of Medicine and Dentistry, Rochester, NY, USA. Electronic address: nikesha_gilmore@urmc.rochester.edu.'}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Targia', 'Affiliation': 'James P Wilmot Cancer Institute, University of Rochester School of Medicine and Dentistry, Rochester, NY, USA.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Conlin', 'Affiliation': 'Pacific Cancer Research Consortium National Cancer Institute Community Oncology Research Program (NCORP), Seattle, WA, USA. Electronic address: alison.conlin@providence.org.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Berenberg', 'Affiliation': 'Hawaii National Cancer Institute Community Oncology Research Program (MU-NCORP), Honolulu, HI, USA. Electronic address: berenber@hawaii.edu.'}, {'ForeName': 'Victor G', 'Initials': 'VG', 'LastName': 'Vogel', 'Affiliation': 'Geisinger Cancer Institute NCORP, Danville, PA, USA. Electronic address: vgvogel@geisinger.edu.'}, {'ForeName': 'Supriya G', 'Initials': 'SG', 'LastName': 'Mohile', 'Affiliation': 'James P Wilmot Cancer Institute, University of Rochester School of Medicine and Dentistry, Rochester, NY, USA. Electronic address: supriya_mohile@urmc.rochester.edu.'}]",Journal of geriatric oncology,['10.1016/j.jgo.2019.12.011'] 841,31917607,Pitolisant for Daytime Sleepiness in Patients with Obstructive Sleep Apnea Who Refuse Continuous Positive Airway Pressure Treatment. A Randomized Trial.,"Rationale: Excessive daytime sleepiness is a common disabling symptom in obstructive sleep apnea syndrome. Objectives: To evaluate the efficacy and safety of pitolisant, a selective histamine H3 receptor antagonist with wake-promoting effects, for the treatment of daytime sleepiness in patients with moderate to severe obstructive sleep apnea refusing continuous positive airway pressure treatment. Methods: In an international, multicenter, double-blind, randomized (3:1), placebo-controlled, parallel-design trial, pitolisant was individually titrated at up to 20 mg/d over 12 weeks. The primary endpoint was the change in the Epworth Sleepiness Scale score. Key secondary endpoints were maintenance of wakefulness assessed on the basis of the Oxford Sleep Resistance test, safety, Clinical Global Impression of severity, patient's global opinion, EuroQol quality-of-life questionnaire, and Pichot fatigue questionnaire. Measurements and Main Results: A total of 268 patients with obstructive sleep apnea (75% male; mean age, 52 yr; apnea-hypopnea index, 49/h; baseline sleepiness score, 15.7) were randomized (200 to pitolisant and 68 to placebo) and analyzed on an intention-to-treat basis. The Epworth Sleepiness Scale score was reduced more with pitolisant than with placebo (-2.8; 95% confidence interval, -4.0 to -1.5; P  < 0.001). Wake maintenance tests were not improved. The Pichot fatigue score was reduced with pitolisant. The overall impact of pitolisant was confirmed by both physicians' and patients' questionnaires. Adverse event incidence, mainly headache, insomnia, nausea, and vertigo, was similar in the pitolisant and placebo groups (29.5% and 25.4%, respectively), with no cardiovascular or other significant safety concerns. Conclusions: Pitolisant significantly reduced self-reported daytime sleepiness and fatigue and improved patient-reported outcomes and physician disease severity assessment in sleepy patients with obstructive sleep apnea refusing or nonadherent to continuous positive airway pressure.Clinical trial registered with www.clinicaltrials.gov (NCT01072968) and EU Clinical Trials Register (EudraCT 2009-017251-94).",2020,"Adverse event incidence, mainly headache, insomnia, nausea, and vertigo, was similar in the pitolisant and placebo groups (29.5% and 25.4%, respectively), with no cardiovascular or other significant safety concerns. ","['268 obstructive sleep apnea patients (75% male; mean age: 52 years, Apnea-hypopnea index: 49/hour, baseline sleepiness score: 15.7) were randomized (200 pitolisant; 68', 'obstructive sleep apnea syndrome', 'Obstructive Sleep Apnea Patients Refusing CPAP', 'sleepy patients with obstructive sleep apnea refusing or non-adherent to continuous positive airway pressure', 'patients with moderate to severe obstructive sleep apnea refusing continuous positive airway pressure treatment']",['placebo'],"['Epworth Sleepiness score', 'Adverse event incidence, mainly headache, insomnia, nausea, and vertigo', 'Daytime Sleepiness', 'self-reported daytime sleepiness, fatigue', 'daytime sleepiness', ""maintenance of wakefulness assessed by the Oxford Sleep Resistance Test, safety, clinical global impressions of severity, patient's global opinion, EQ-5D quality-of-life, and Pichot Fatigue questionnaire scores"", 'Pichot fatigue score', 'change in the Epworth Sleepiness score']","[{'cui': 'C4517673', 'cui_str': '268'}, {'cui': 'C0520679', 'cui_str': 'Syndrome, Sleep Apnea, Obstructive'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C2111846', 'cui_str': 'Apnea-hypopnea index'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C2830004', 'cui_str': 'Somnolence'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C3529928', 'cui_str': 'Pitolisant (substance)'}, {'cui': 'C1705116', 'cui_str': 'Refused (qualifier value)'}, {'cui': 'C0199451', 'cui_str': 'Continuous Positive Airway Pressure'}, {'cui': 'C0013144', 'cui_str': 'Drowsy (finding)'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C2830004', 'cui_str': 'Somnolence'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042571', 'cui_str': 'Spinning Sensation'}, {'cui': 'C0541854', 'cui_str': 'Daytime sleepiness'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C0043012', 'cui_str': 'Wakefulnesses'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0871010', 'cui_str': 'Opinions'}, {'cui': 'C0034380'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0443172', 'cui_str': 'State changes'}]",268.0,0.277263,"Adverse event incidence, mainly headache, insomnia, nausea, and vertigo, was similar in the pitolisant and placebo groups (29.5% and 25.4%, respectively), with no cardiovascular or other significant safety concerns. ","[{'ForeName': 'Yves', 'Initials': 'Y', 'LastName': 'Dauvilliers', 'Affiliation': 'National Reference Center for Narcolepsy, Sleep and Wake Unit, Department of Neurology, Gui-de-Chauliac Hospital, Montpellier University Hospital, Montpellier, France.'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Verbraecken', 'Affiliation': 'Multidisciplinary Sleep Disorders Center, Antwerp University Hospital and University of Antwerp, Antwerp, Belgium.'}, {'ForeName': 'Markku', 'Initials': 'M', 'LastName': 'Partinen', 'Affiliation': 'Helsinki Sleep Clinic, Vitalmed Research Center, Helsinki, Finland.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Hedner', 'Affiliation': 'Sleep and Vigilance Laboratory, Department of Internal Medicine, University of Göteborg, Sahlgrenska University Hospital, University of Göteborg, Göteborg, Sweden.'}, {'ForeName': 'Tarja', 'Initials': 'T', 'LastName': 'Saaresranta', 'Affiliation': 'Sleep Research Center, Department of Pulmonary Diseases and Clinical Allergology, University of Turku, Turku, Finland.'}, {'ForeName': 'Ognian', 'Initials': 'O', 'LastName': 'Georgiev', 'Affiliation': 'Pulmonology Unit, Department of Internal Medicine, Alexandrovska Hospital Medical University, Sofia, Bulgaria.'}, {'ForeName': 'Rumen', 'Initials': 'R', 'LastName': 'Tiholov', 'Affiliation': 'Department of Internal Diseases, Sveti Ivan Rilski Multiprofile Hospital for Active Treatment, Kozloduy, Bulgaria.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Lecomte', 'Affiliation': 'Bioprojet, 30 rue Francs Bourgois, Paris, France.'}, {'ForeName': 'Renaud', 'Initials': 'R', 'LastName': 'Tamisier', 'Affiliation': 'Hypoxia-Physiopathology (HP2) Laboratory, INSERM U1042, University Grenoble Alpes, Grenoble, France; and.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Lévy', 'Affiliation': 'Hypoxia-Physiopathology (HP2) Laboratory, INSERM U1042, University Grenoble Alpes, Grenoble, France; and.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Scart-Gres', 'Affiliation': 'Bioprojet, 30 rue Francs Bourgois, Paris, France.'}, {'ForeName': 'Jeanne-Marie', 'Initials': 'JM', 'LastName': 'Lecomte', 'Affiliation': 'Bioprojet, 30 rue Francs Bourgois, Paris, France.'}, {'ForeName': 'Jean-Charles', 'Initials': 'JC', 'LastName': 'Schwartz', 'Affiliation': 'Bioprojet, 30 rue Francs Bourgois, Paris, France.'}, {'ForeName': 'Jean-Louis', 'Initials': 'JL', 'LastName': 'Pépin', 'Affiliation': 'Hypoxia-Physiopathology (HP2) Laboratory, INSERM U1042, University Grenoble Alpes, Grenoble, France; and.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American journal of respiratory and critical care medicine,['10.1164/rccm.201907-1284OC'] 842,31559633,Does the time-point of orthodontic space closure initiation after tooth extraction affect the incidence of gingival cleft development? A randomized controlled clinical trial.,"BACKGROUND Gingival clefts (GCs) develop frequently during orthodontic space closure and may compromise the treatment outcome. This study assessed whether the time-point of orthodontic space closure initiation, after permanent tooth extraction, affects the incidence of GC. METHODS In 25 patients requiring bilateral premolar extraction because of orthodontic reasons, one premolar, chosen at random, was extracted 8 weeks before space closure initiation (""delayed movement,"" DM), whereas the contralateral premolar was extracted 1 week before (""early movement,"" EM) (""treatment group""). Presence or absence of GC after 3 and 6 months (""time-point"") was recorded and any association with various parameters (i.e., treatment group, time-point, gender, jaw, craniofacial growth, gingival biotype, buccal bone dehiscence after extraction, space closure) was statistically assessed. RESULTS Twenty-one patients contributing with 26 jaws were finally included in the analysis. Overall, GCs were frequent after 3 (DM: 53.9%; EM: 69.2%) and 6 months (DM: 76.9%; EM: 88.5%). EM (P = 0.014) and larger space closure within the study period (P = 0.001) resulted in a significantly higher incidence of GC. Further, there was a tendency for GC development in the presence of buccal bone dehiscence (P = 0.052) and thin gingival biotype (P = 0.054). ""Fast movers"" (herein cases with a tooth movement ≥1 mm per month) developed a GC in >90% of the cases already after 3 months. ""Slow movers"" developed a GC in 25% and 70% after 3 months and final evaluation, respectively. CONCLUSIONS GC development is a frequent finding during orthodontic space closure and seems to occur more frequently with early tooth movement initiation and in ""fast movers.""",2020,EM (p = 0.014) and larger space closure within the study period (p = 0.001) resulted in a significantly higher incidence of GC.,"['Twenty-one patients contributing with 26 jaws were finally included in the analysis', '25 patients requiring bilateral premolar extraction due to orthodontic reasons, one premolar, chosen at random']",[],"['larger space closure', 'buccal bone dehiscence', 'time-point, gender, jaw, craniofacial growth, gingival biotype, buccal bone dehiscence after extraction, space closure']","[{'cui': 'C3715213', 'cui_str': '21 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0022359', 'cui_str': 'Jaw'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C1704302', 'cui_str': 'Premolar'}, {'cui': 'C0185115', 'cui_str': 'Extraction - action (qualifier value)'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0029335', 'cui_str': 'Orthodontics'}, {'cui': 'C0684328', 'cui_str': 'Reasoning'}, {'cui': 'C0439605', 'cui_str': 'Random (qualifier value)'}]",[],"[{'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}, {'cui': 'C0185003', 'cui_str': 'Reparative closure (procedure)'}, {'cui': 'C0442010', 'cui_str': 'Buccal (qualifier value)'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0149663', 'cui_str': 'Dehiscence (morphologic abnormality)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0022359', 'cui_str': 'Jaw'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C4521854', 'cui_str': 'Gingival (intended site)'}, {'cui': 'C0449562', 'cui_str': 'Biotype (attribute)'}, {'cui': 'C0185115', 'cui_str': 'Extraction - action (qualifier value)'}]",,0.157475,EM (p = 0.014) and larger space closure within the study period (p = 0.001) resulted in a significantly higher incidence of GC.,"[{'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Bertl', 'Affiliation': 'Department of Periodontology, Faculty of Odontology, University of Malmö, Malmö, Sweden.'}, {'ForeName': 'Hemma', 'Initials': 'H', 'LastName': 'Neuner', 'Affiliation': 'Division of Orthodontics, University Clinic of Dentistry, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Antonia', 'Initials': 'A', 'LastName': 'Meran', 'Affiliation': 'Division of Orthodontics, University Clinic of Dentistry, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Michael H', 'Initials': 'MH', 'LastName': 'Bertl', 'Affiliation': 'Division of Orthodontics, University Clinic of Dentistry, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Ilse', 'Initials': 'I', 'LastName': 'Reich', 'Affiliation': 'Division of Conservative Dentistry and Periodontology, University Clinic of Dentistry, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Nemec', 'Affiliation': 'Division of Orthodontics, University Clinic of Dentistry, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Corinna', 'Initials': 'C', 'LastName': 'Bruckmann', 'Affiliation': 'Division of Conservative Dentistry and Periodontology, University Clinic of Dentistry, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Stavropoulos', 'Affiliation': 'Department of Periodontology, Faculty of Odontology, University of Malmö, Malmö, Sweden.'}, {'ForeName': 'Hans-Peter', 'Initials': 'HP', 'LastName': 'Bantleon', 'Affiliation': 'Division of Orthodontics, University Clinic of Dentistry, Medical University of Vienna, Vienna, Austria.'}]",Journal of periodontology,['10.1002/JPER.19-0376'] 843,31924539,Effect of a differentiated service delivery model on virological failure in adolescents with HIV in Zimbabwe (Zvandiri): a cluster-randomised controlled trial.,"BACKGROUND Adolescents living with HIV face challenges to their wellbeing and antiretroviral therapy adherence and have poor treatment outcomes. We aimed to evaluate a peer-led differentiated service delivery intervention on HIV clinical and psychosocial outcomes among adolescents with HIV in Zimbabwe. METHODS 16 public primary care facilities (clusters) in two rural districts in Zimbabwe (Bindura and Shamva) were randomly assigned (1:1) to provide enhanced HIV care support (the Zvandiri intervention group) or standard HIV care (the control group) to adolescents (aged 13-19 years) with HIV. Eligible clinics had at least 20 adolescents in pre-ART or ART registers and were geographically separated by at least 10 km to minimise contamination. Adolescents were eligible for inclusion if they were living with HIV, registered for HIV care at one of the trial clinics, and either starting or already on ART. Exclusion criteria were being too physically unwell to attend clinic (bedridden), psychotic, or unable to give informed assent or consent. Adolescents with HIV at all clinics received adherence support through adult counsellors. At intervention clinics, adolescents with HIV were assigned a community adolescent treatment supporter, attended a monthly support group, and received text messages, calls, home visits, and clinic-based counselling. Implementation intensity was differentiated according to each adolescent's HIV vulnerability, which was reassessed every 3 months. Caregivers were invited to a support group. The primary outcome was the proportion of adolescents who had died or had a viral load of at least 1000 copies per μL after 96 weeks. In-depth qualitative data were collected and analysed thematically. The trial is registered with Pan African Clinical Trial Registry, number PACTR201609001767322. FINDINGS Between Aug 15, 2016, and March 31, 2017, 500 adolescents with HIV were enrolled, of whom four were excluded after group assignment owing to testing HIV negative. Of the remaining 496 adolescents, 212 were recruited at Zvandiri intervention sites and 284 at control sites. At enrolment, the median age was 15 years (IQR 14-17), 52% of adolescents were female, 81% were orphans, and 47% had a viral load of at least 1000 copies per μL. 479 (97%) had primary outcome data at endline, including 28 who died. At 96 weeks, 52 (25%) of 209 adolescents in the Zvandiri intervention group and 97 (36%) of 270 adolescents in the control group had an HIV viral load of at least 1000 copies per μL or had died (adjusted prevalence ratio 0·58, 95% CI 0·36-0·94; p=0·03). Qualitative data suggested that the multiple intervention components acted synergistically to improve the relational context in which adolescents with HIV live, supporting their improved adherence. No adverse events were judged to be related to study procedures. Severe adverse events were 28 deaths (17 in the Zvandiri intervention group, 11 in the control group) and 57 admissions to hospital (20 in the Zvandiri intervention group, 37 in the control group). INTERPRETATION Peer-supported community-based differentiated service delivery can substantially improve HIV virological suppression in adolescents with HIV and should be scaled up to reduce their high rates of morbidity and mortality. FUNDING Positive Action for Adolescents Program, ViiV Healthcare.",2020,No adverse events were judged to be related to study procedures.,"['Adolescents were eligible for inclusion if they were living with HIV, registered for HIV care at one of the trial clinics, and either starting or already on ART', 'adolescents with HIV in Zimbabwe (Zvandiri', 'Eligible clinics had at least 20 adolescents in pre-ART or ART registers and were geographically separated by at least 10 km to minimise contamination', 'Adolescents living with HIV', 'adolescents with HIV in Zimbabwe', '16 public primary care facilities (clusters) in two rural districts in Zimbabwe (Bindura and Shamva', '500 adolescents with HIV were enrolled, of whom four were excluded after group assignment owing to testing HIV negative', 'Between Aug 15, 2016, and March 31, 2017', 'Exclusion criteria were being too physically unwell to attend clinic (bedridden), psychotic, or unable to give informed assent or consent', 'adolescents with HIV', 'the control group) to adolescents (aged 13-19 years) with HIV', 'Of the remaining 496 adolescents, 212 were recruited at Zvandiri intervention sites and 284 at control sites', 'Adolescents with HIV at all clinics received adherence support through adult counsellors']","['differentiated service delivery model', 'peer-led differentiated service delivery intervention', 'community adolescent treatment supporter, attended a monthly support group, and received text messages, calls, home visits, and clinic-based counselling', 'Zvandiri intervention', 'provide enhanced HIV care support (the Zvandiri intervention group) or standard HIV care']","['HIV virological suppression', 'viral load', 'HIV viral load', 'virological failure', 'proportion of adolescents who had died or had a viral load', 'Severe adverse events', 'adverse events', 'HIV clinical and psychosocial outcomes']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0043476', 'cui_str': 'Southern Rhodesia'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0443299', 'cui_str': 'Separate (qualifier value)'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C3816747', 'cui_str': 'Five hundred'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0481430', 'cui_str': 'HTLV-3 antibody negative'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C4285956', 'cui_str': 'Physically unwell'}, {'cui': 'C0730261', 'cui_str': 'Attends outpatients'}, {'cui': 'C0033975', 'cui_str': 'Psychoses'}, {'cui': 'C1299582', 'cui_str': 'Unable'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0205615', 'cui_str': 'Well differentiated (qualifier value)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}, {'cui': 'C0036606', 'cui_str': 'Support Groups'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0020043', 'cui_str': 'Home Visits'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0205466', 'cui_str': 'virology'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression (disorder)'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C1168369', 'cui_str': 'HIV viral load'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C1546956', 'cui_str': 'Dead (finding)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}]",500.0,0.208804,No adverse events were judged to be related to study procedures.,"[{'ForeName': 'Webster', 'Initials': 'W', 'LastName': 'Mavhu', 'Affiliation': 'Centre for Sexual Health and HIV/AIDS Research (CeSHHAR), Harare, Zimbabwe; Department of International Public Health, Liverpool School of Tropical Medicine, Liverpool, UK. Electronic address: webster.mavhu@lstmed.ac.uk.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Willis', 'Affiliation': 'Africaid, Harare, Zimbabwe.'}, {'ForeName': 'Juliet', 'Initials': 'J', 'LastName': 'Mufuka', 'Affiliation': 'Centre for Sexual Health and HIV/AIDS Research (CeSHHAR), Harare, Zimbabwe.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Bernays', 'Affiliation': 'School of Public Health, University of Sydney, Sydney, Australia; MRC Tropical Epidemiology Group, London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Maureen', 'Initials': 'M', 'LastName': 'Tshuma', 'Affiliation': 'Centre for Sexual Health and HIV/AIDS Research (CeSHHAR), Harare, Zimbabwe.'}, {'ForeName': 'Collin', 'Initials': 'C', 'LastName': 'Mangenah', 'Affiliation': 'Centre for Sexual Health and HIV/AIDS Research (CeSHHAR), Harare, Zimbabwe.'}, {'ForeName': 'Hendramoorthy', 'Initials': 'H', 'LastName': 'Maheswaran', 'Affiliation': 'Institute of Psychology, Health, and Society, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Mangezi', 'Affiliation': 'Department of Psychiatry, University of Zimbabwe College of Health Sciences, Harare, Zimbabwe.'}, {'ForeName': 'Tsitsi', 'Initials': 'T', 'LastName': 'Apollo', 'Affiliation': 'AIDS and TB Unit, Ministry of Health and Child Care, Harare, Zimbabwe.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Araya', 'Affiliation': ""Health Services and Population Research Department, King's College London, London, UK.""}, {'ForeName': 'Helen A', 'Initials': 'HA', 'LastName': 'Weiss', 'Affiliation': 'MRC Tropical Epidemiology Group, London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'Frances M', 'Initials': 'FM', 'LastName': 'Cowan', 'Affiliation': 'Centre for Sexual Health and HIV/AIDS Research (CeSHHAR), Harare, Zimbabwe; Department of International Public Health, Liverpool School of Tropical Medicine, Liverpool, UK.'}]",The Lancet. Global health,['10.1016/S2214-109X(19)30526-1'] 844,31571341,A crowdsourced intervention to decrease hepatitis B stigma in men who have sex with men in China: A cohort study.,"Stigma against people with hepatitis B virus (HBV) is a barrier to prevention, diagnosis and treatment of HBV in China. Our study examined an innovative intervention to reduce HBV stigma among men who have sex with men (MSM) in China. We extracted data from a randomized controlled trial conducted in May 2018, where the intervention consisted of crowdsourced images and videos to promote viral hepatitis testing and reduce HBV stigma. HBV stigma was assessed using a 20-item scale at baseline and four weeks post-enrolment. Participants were divided into three groups based on their exposure to intervention: full exposure, partial exposure and no exposure. Linear regression was used to determine associations between baseline stigma and participant characteristics. Data from 470 MSM were analysed. Mean participant age was 25 years old and 56% had less education than a college bachelor's degree. Full exposure to intervention was associated with significant stigma reduction (adjusted beta = -3.49; 95% CI = -6.11 to -0.87; P = .01), while partial exposure led to stigma reduction that was not statistically significant. The mean stigma score was 50.6 (SD ± 14.7) at baseline, and stigma was most prominent regarding physical contact with HBV carriers. Greater HBV stigma was associated with not having a recent doctor's visit (adjusted beta = 4.35, 95% CI = 0.19 to 8.52; P = .04). In conclusion, crowdsourcing can decrease HBV stigma among MSM in China and may be useful in anti-stigma campaigns for vulnerable populations in low- and middle-income countries.",2020,"Full exposure to intervention was associated with significant stigma reduction (adjusted beta = -3.49; 95% CI = -6.11 to -0.87; p = 0.01), while partial exposure led to stigma reduction that was not statistically significant.","['Stigma against people with hepatitis B virus (HBV', 'men who have sex with men (MSM) in China', ""Mean participant age was 25 years old and 56% had less education than a college bachelor's degree"", 'men who have sex with men in China']","['innovative intervention', 'crowdsourced intervention']","['Greater HBV stigma', 'HBV stigma', 'hepatitis B stigma', 'stigma reduction', 'mean stigma score']","[{'cui': 'C0277787', 'cui_str': 'Stigma (finding)'}, {'cui': 'C0019169', 'cui_str': 'Hepatitis B Virus'}, {'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0337600', 'cui_str': 'Bachelor (finding)'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}]",[],"[{'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0277787', 'cui_str': 'Stigma (finding)'}, {'cui': 'C0019163', 'cui_str': 'Hepatitis B Virus Infection'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",470.0,0.0896313,"Full exposure to intervention was associated with significant stigma reduction (adjusted beta = -3.49; 95% CI = -6.11 to -0.87; p = 0.01), while partial exposure led to stigma reduction that was not statistically significant.","[{'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Shen', 'Affiliation': 'Department of Internal Medicine, Washington University in St. Louis, St. Louis, MO, USA.'}, {'ForeName': 'Nancy S', 'Initials': 'NS', 'LastName': 'Yang', 'Affiliation': 'University of Minnesota Medical School - Twin Cities, Minneapolis, MN, USA.'}, {'ForeName': 'Wenting', 'Initials': 'W', 'LastName': 'Huang', 'Affiliation': 'University of North Carolina at Chapel Hill, Project China, Guangzhou, China.'}, {'ForeName': 'Thomas S', 'Initials': 'TS', 'LastName': 'Fitzpatrick', 'Affiliation': 'Department of Medicine, University of Washington School of Medicine, Seattle, WA, USA.'}, {'ForeName': 'Weiming', 'Initials': 'W', 'LastName': 'Tang', 'Affiliation': 'University of North Carolina at Chapel Hill, Project China, Guangzhou, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'University of North Carolina at Chapel Hill, Project China, Guangzhou, China.'}, {'ForeName': 'Yehua', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'University of North Carolina at Chapel Hill, Project China, Guangzhou, China.'}, {'ForeName': 'Linghua', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': ""Center for Infectious Diseases, Guangzhou Eighth People's Hospital, Guangzhou, China.""}, {'ForeName': 'Joseph D', 'Initials': 'JD', 'LastName': 'Tucker', 'Affiliation': 'University of North Carolina at Chapel Hill, Project China, Guangzhou, China.'}]",Journal of viral hepatitis,['10.1111/jvh.13213'] 845,30638771,The effect of structured personal care on RNA oxidation: A 19-year follow-up of the randomized trial Diabetes Care in General Practice (DCGP).,"AIMS The urinary marker of RNA oxidation, 8‑oxo‑7,8‑dihydroguanosine (8-oxoGuo), but not the corresponding marker of DNA oxidation, 8‑oxo‑7,8‑dihydro‑2'‑deoxyguanosine (8-oxodG), is a prognostic biomarker in patients with type 2 diabetes (T2D). The aim of the present study was to investigate the effect of structured personal care (individualized multifactorial treatment) versus standard care on RNA oxidation level in patients with T2D and to assess if the effect of structured personal care on all-cause and diabetes-related mortality was modified by RNA oxidation level. METHODS Urine samples were analyzed for 8-oxoGuo/8-oxodG from 1381 newly diagnosed T2D patients from the cluster randomized trial Diabetes Care in General Practice cohort, and 970 patients were reexamined after six years of intervention. RESULTS The yearly variation in RNA oxidation levels were not significantly different between the structured personal care group and standard care group. The effect of treatment on all-cause and diabetes-related mortality was not modified by the level of RNA oxidation. No changes in DNA oxidation were seen. CONCLUSIONS Structured personal care does not influence RNA oxidation level nor is it better for patients with high RNA oxidation level. Thus, structured personal care may not impact the disease-related aspects identified by RNA oxidation level in T2D patients.",2019,The yearly variation in RNA oxidation levels were not significantly different between the structured personal care group and standard care group.,"['T2D patients', 'Urine samples were analyzed for 8-oxoGuo/8-oxodG from 1381 newly diagnosed T2D patients from the cluster randomized trial Diabetes Care in General Practice cohort, and 970 patients were reexamined after six years of intervention', 'patients with type 2 diabetes (T2D', 'patients with T2D', 'patients with high RNA oxidation level']","['structured personal care (individualized multifactorial treatment) versus standard care', 'structured personal care', 'structured personal care on RNA oxidation']","['RNA oxidation level', 'RNA oxidation levels', 'DNA oxidation', 'urinary marker of RNA oxidation, 8‑oxo‑7,8‑dihydroguanosine (8-oxoGuo']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1610733', 'cui_str': 'Urine specimen'}, {'cui': 'C0086343', 'cui_str': 'General Practice'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0035668', 'cui_str': 'RNA'}, {'cui': 'C0030011', 'cui_str': 'Oxidation, function (observable entity)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]","[{'cui': 'C0036592', 'cui_str': 'Self Care'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0035668', 'cui_str': 'RNA'}, {'cui': 'C0030011', 'cui_str': 'Oxidation, function (observable entity)'}]","[{'cui': 'C0035668', 'cui_str': 'RNA'}, {'cui': 'C0030011', 'cui_str': 'Oxidation, function (observable entity)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0012854', 'cui_str': 'Deoxyribonucleic Acid'}, {'cui': 'C0050092', 'cui_str': '8-oxoG nucleoside'}]",1381.0,0.0291654,The yearly variation in RNA oxidation levels were not significantly different between the structured personal care group and standard care group.,"[{'ForeName': 'Laura Kofoed', 'Initials': 'LK', 'LastName': 'Kjaer', 'Affiliation': 'Department of Clinical Pharmacology, Bispebjerg and Frederiksberg Hospital, Copenhagen, Denmark; Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark. Electronic address: laura.kofoed.kjaer@regionh.dk.'}, {'ForeName': 'Mia Klinten', 'Initials': 'MK', 'LastName': 'Grand', 'Affiliation': 'The Research Unit for General Practice and Section of General Practice, Department of Public Health, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Volkert', 'Initials': 'V', 'LastName': 'Siersma', 'Affiliation': 'The Research Unit for General Practice and Section of General Practice, Department of Public Health, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Kasper', 'Initials': 'K', 'LastName': 'Broedbaek', 'Affiliation': 'Department of Clinical Pharmacology, Bispebjerg and Frederiksberg Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Jorgensen', 'Affiliation': 'Psychiatric Center Copenhagen (Rigshospitalet), Mental Health Services of the Capital Region of Denmark, Denmark.'}, {'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'de Fine Olivarius', 'Affiliation': 'The Research Unit for General Practice and Section of General Practice, Department of Public Health, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Henrik Enghusen', 'Initials': 'HE', 'LastName': 'Poulsen', 'Affiliation': 'Department of Clinical Pharmacology, Bispebjerg and Frederiksberg Hospital, Copenhagen, Denmark; Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}]",Journal of diabetes and its complications,['10.1016/j.jdiacomp.2018.12.004'] 846,31391011,Effects of adjunct testosterone on cardiac morphology and function in advanced cancers: an ancillary analysis of a randomized controlled trial.,"BACKGROUND Adjunct testosterone therapy improves lean body mass, quality of life, and physical activity in patients with advanced cancers; however, the effects of testosterone on cardiac morphology and function are unknown. Accordingly, as an ancillary analysis of a randomized, placebo-controlled trial investigating the efficacy of testosterone supplementation on body composition in men and women with advanced cancers, we explored whether testosterone supplementation could prevent or reverse left ventricular (LV) atrophy and dysfunction. METHODS Men and women recently diagnosed with late stage (≥IIB) or recurrent head and neck or cervical cancer who were scheduled to receive standard of care chemotherapy or concurrent chemoradiation were administered an adjunct 7 week treatment of weekly intramuscular injections of either 100 mg testosterone (T, n = 1 M/5F) or placebo (P, n = 6 M/4F) in a double-blinded randomized fashion. LV morphology (wall thickness), systolic function (ejection fraction, EF), diastolic function (E/A; E'/E), arterial elastance (Ea), end-systolic elastance (Ees), and ventricular-arterial coupling (Ea/Ees) were assessed. RESULTS No significant differences were observed in LV posterior wall thickness in placebo (pre: 1.10 ± 0.1 cm; post: 1.16 ± 0.2 cm; p = 0.11) or testosterone groups (pre: 0.99 ± 0.1 cm; post: 1.14 ± 0.20 cm; p = 0.22). Compared with placebo, testosterone significantly improved LVEF (placebo: - 1.8 ± 4.3%; testosterone: + 6.2 ± 4.3%; p < 0.05), Ea (placebo: 0.0 ± 0.2 mmHg/mL; testosterone: - 0.3 ± 0.2 mmHg/mL; p < 0.05), and Ea/Ees (placebo: 0.0 ± 0.1; testosterone: - 0.2 ± 0.1; p < 0.05). CONCLUSIONS In patients with advanced cancers, testosterone was associated with favorable changes in left ventricular systolic function, arterial elastance, and ventricular-arterial coupling. Given the small sample size, the promising multisystem benefits of testosterone warrants further evaluation in a definitive randomized trial. TRIAL REGISTRATION This study was prospectively registered on ClinicalTrials.gov (NCT00878995; date of registration: April 9, 2009).",2019,"Compared with placebo, testosterone significantly improved LVEF (placebo: - 1.8 ± 4.3%; testosterone: + 6.2 ± 4.3%; p < 0.05), Ea (placebo: 0.0 ± 0.2 mmHg/mL; testosterone: - 0.3 ± 0.2 mmHg/mL; p < 0.05), and Ea/Ees (placebo: 0.0 ± 0.1; testosterone: - 0.2 ± 0.1; p < 0.05). ","['advanced cancers', 'men and women with advanced cancers', 'patients with advanced cancers', 'Men and women recently diagnosed with late stage (≥IIB) or recurrent head and neck or cervical cancer who were scheduled to receive']","['placebo, testosterone', 'adjunct testosterone', 'LVEF (placebo', 'testosterone supplementation', 'standard of care chemotherapy or', 'placebo', 'testosterone (T, n\xa0', 'testosterone', 'testosterone therapy', 'placebo (P, n\xa0=\u20096\u2009M/4F']","['LV posterior wall thickness', 'left ventricular systolic function, arterial elastance, and ventricular-arterial coupling', 'body composition', ""LV morphology (wall thickness), systolic function (ejection fraction, EF), diastolic function (E/A; E'/E), arterial elastance (Ea), end-systolic elastance (Ees), and ventricular-arterial coupling (Ea/Ees"", 'cardiac morphology and function', 'reverse left ventricular (LV) atrophy and dysfunction', 'lean body mass, quality of life, and physical activity']","[{'cui': 'C0877373', 'cui_str': 'Advanced cancer'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C1279941', 'cui_str': 'Late stage (qualifier value)'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0018670', 'cui_str': 'Head'}, {'cui': 'C0027536', 'cui_str': 'Necking (finding)'}, {'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix (disorder)'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0523912', 'cui_str': 'Testosterone measurement (procedure)'}, {'cui': 'C2936643', 'cui_str': 'Standard of Care'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0442071', 'cui_str': 'Posterior wall (qualifier value)'}, {'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0221464', 'cui_str': 'Arterial (qualifier value)'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0543482', 'cui_str': 'morphology'}, {'cui': 'C0205380', 'cui_str': 'Walled (qualifier value)'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0333641', 'cui_str': 'Atrophy'}, {'cui': 'C0031847', 'cui_str': 'pathophysiology'}, {'cui': 'C0424678', 'cui_str': 'Lean body mass (observable entity)'}, {'cui': 'C0034380'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]",,0.774556,"Compared with placebo, testosterone significantly improved LVEF (placebo: - 1.8 ± 4.3%; testosterone: + 6.2 ± 4.3%; p < 0.05), Ea (placebo: 0.0 ± 0.2 mmHg/mL; testosterone: - 0.3 ± 0.2 mmHg/mL; p < 0.05), and Ea/Ees (placebo: 0.0 ± 0.1; testosterone: - 0.2 ± 0.1; p < 0.05). ","[{'ForeName': 'Jessica M', 'Initials': 'JM', 'LastName': 'Scott', 'Affiliation': 'Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'E Lichar', 'Initials': 'EL', 'LastName': 'Dillon', 'Affiliation': 'Department of Internal Medicine, The University of Texas Medical Branch, Galveston, TX, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Kinsky', 'Affiliation': 'Department of Anesthesiology, The University of Texas Medical Branch, Galveston, TX, USA.'}, {'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Chamberlain', 'Affiliation': 'Department of Internal Medicine, The University of Texas Medical Branch, Galveston, TX, USA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'McCammon', 'Affiliation': 'Department of Otolaryngology, The University of Texas Medical Branch, Galveston, TX, USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Jupiter', 'Affiliation': 'Department of Preventive Medicine and Community Health, The University of Texas Medical Branch, Galveston, TX, USA.'}, {'ForeName': 'Maurice', 'Initials': 'M', 'LastName': 'Willis', 'Affiliation': 'Department of Internal Medicine, The University of Texas Medical Branch, Galveston, TX, USA.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Hatch', 'Affiliation': 'Department of Radiation Oncology, The University of Texas Medical Branch, Galveston, TX, USA.'}, {'ForeName': 'Gwyn', 'Initials': 'G', 'LastName': 'Richardson', 'Affiliation': 'Department of Gynecologic Oncology, The University of Texas Medical Branch, Galveston, TX, USA.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Danesi', 'Affiliation': 'Department of Internal Medicine, The University of Texas Medical Branch, Galveston, TX, USA.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Randolph', 'Affiliation': 'Department of Internal Medicine, The University of Texas Medical Branch, Galveston, TX, USA.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Durham', 'Affiliation': 'Department of Internal Medicine, The University of Texas Medical Branch, Galveston, TX, USA.'}, {'ForeName': 'Traver', 'Initials': 'T', 'LastName': 'Wright', 'Affiliation': 'Department of Internal Medicine, The University of Texas Medical Branch, Galveston, TX, USA.'}, {'ForeName': 'Randall', 'Initials': 'R', 'LastName': 'Urban', 'Affiliation': 'Department of Internal Medicine, The University of Texas Medical Branch, Galveston, TX, USA.'}, {'ForeName': 'Melinda', 'Initials': 'M', 'LastName': 'Sheffield-Moore', 'Affiliation': 'Department of Internal Medicine, The University of Texas Medical Branch, Galveston, TX, USA. msheffield-moore@tamu.edu.'}]",BMC cancer,['10.1186/s12885-019-6006-5'] 847,31278996,Brief Behavioral Therapy for Pediatric Anxiety and Depression in Primary Care: A Follow-up.,"OBJECTIVE To report on the 32-week outcome of the Brief Behavioral Therapy (BBT) for Pediatric Anxiety and Depression in Primary Care clinical trial. METHOD A total of 185 youths aged 8 to 17 years with anxiety and/or depression identified through 9 pediatric primary care (PPC) settings in San Diego and Pittsburgh were randomized to receive Assisted Referral to Care (ARC) or up to 12 sessions of BBT over 16 weeks. The primary outcome was clinical response across anxiety and depression, defined as a Clinical Global Impressions-Improvement Score of ≤2. Secondary outcomes included interview-rated functioning, depression, and anxiety. Here, we report on outcomes at 32 weeks after randomization. All analyses with primary outcomes are corrected for multiple comparisons using the false discovery rate procedure. RESULTS At 32 weeks, BBT was superior to ARC with respect to response (67.5% versus 43.1%, q = 0.03, number needed to treat [NNT] = 5) and functioning (d = 0.49, q = 0.04). BBT was superior to ARC with respect to its impact on anxiety (f = 0.21) but not depressive symptoms (f = 0.05). These findings persisted after controlling for the number of sessions received. Ethnicity moderated the impact of BBT on outcome (NNT for Hispanic youths = 2), because of a much lower response rate to ARC in Hispanic than in non-Hispanic youths (16.7% versus 49.2%, p = 0.04). CONCLUSION BBT is a promising intervention that can be effectively delivered in PPC and may be particularly effective for Hispanic patients. Further work is indicated to improve its impact on depressive symptoms and to test BBT against other treatments delivered in pediatric primary care. CLINICAL TRIAL REGISTRATION INFORMATION Brief Cognitive Behavioral Therapy (CBT) for Pediatric Anxiety and Depression in Primary Care; http://clinicaltrials.gov; NCT01147614.",2020,BBT was superior to ARC with respect to its impact on anxiety (f=0.21) but not depressive symptoms (f=0.05).,"['PPC) settings in San Diego and Pittsburgh', 'Hispanic patients', 'Pediatric Anxiety and Depression in Primary Care', '185 youth aged 8-17 with anxiety and/or depression identified through 9 pediatric primary care']","['Brief Behavioral Therapy (BBT', 'Brief Behavioral Therapy', 'Assisted Referral to Care (ARC', 'BBT']","['interview-rated functioning, depression, and anxiety', 'False Discovery Rate technique', 'clinical response across anxiety and depression, defined as a Clinical Global Impressions-Improvement Score ≤ 2', 'anxiety']","[{'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C4517617', 'cui_str': '185 (qualifier value)'}, {'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}]","[{'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0004933', 'cui_str': 'Behavior Modification'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C2585021', 'cui_str': 'Referral to'}, {'cui': 'C0001857', 'cui_str': 'Lymphadenopathy Syndrome'}]","[{'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0205237', 'cui_str': 'False (qualifier value)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",185.0,0.0469208,BBT was superior to ARC with respect to its impact on anxiety (f=0.21) but not depressive symptoms (f=0.05).,"[{'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Brent', 'Affiliation': 'UPMC Western Psychiatric Hospital, Pittsburgh, Pennsylvania; University of Pittsburgh School of Medicine, Pennsylvania. Electronic address: brentda@upmc.edu.'}, {'ForeName': 'Giovanna', 'Initials': 'G', 'LastName': 'Porta', 'Affiliation': 'UPMC Western Psychiatric Hospital, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Michelle S', 'Initials': 'MS', 'LastName': 'Rozenman', 'Affiliation': 'University of Denver, Colorado.'}, {'ForeName': 'Araceli', 'Initials': 'A', 'LastName': 'Gonzalez', 'Affiliation': 'California State University, Long Beach.'}, {'ForeName': 'Karen T G', 'Initials': 'KTG', 'LastName': 'Schwartz', 'Affiliation': 'San Diego State University/University of California, San Diego Joint Doctoral Program in Clinical Psychology, San Diego.'}, {'ForeName': 'Frances L', 'Initials': 'FL', 'LastName': 'Lynch', 'Affiliation': 'Center for Health Research, Kaiser Permanente Northwest, Portland, Oregon.'}, {'ForeName': 'John F', 'Initials': 'JF', 'LastName': 'Dickerson', 'Affiliation': 'Center for Health Research, Kaiser Permanente Northwest, Portland, Oregon.'}, {'ForeName': 'Satish', 'Initials': 'S', 'LastName': 'Iyengar', 'Affiliation': 'University of Pittsburgh, Pennsylvania.'}, {'ForeName': 'V Robin', 'Initials': 'VR', 'LastName': 'Weersing', 'Affiliation': 'San Diego State University/University of California, San Diego Joint Doctoral Program in Clinical Psychology, San Diego.'}]",Journal of the American Academy of Child and Adolescent Psychiatry,['10.1016/j.jaac.2019.06.009'] 848,31924562,The effect of dulaglutide on stroke: an exploratory analysis of the REWIND trial.,"BACKGROUND Cardiovascular outcome trials have suggested that glucagon-like peptide 1 (GLP-1) receptor agonists might reduce strokes. We analysed the effect of dulaglutide on stroke within the researching cardiovascular events with a weekly incretin in diabetes (REWIND) trial. METHODS REWIND was a multicentre, randomised, double-blind, placebo-controlled trial done at 371 sites in 24 countries. Men and women (aged ≥50 years) with established or newly detected type 2 diabetes whose HbA 1c was 9·5% or less (with no lower limit) on stable doses of up to two oral glucose-lowering drugs with or without basal insulin therapy were eligible if their body-mass index was at least 23 kg/m 2 . Participants were randomly assigned (1:1) to weekly subcutaneous injections of either masked dulaglutide 1·5 mg or the same volume of masked placebo (containing the same excipients but without dulaglutide). Randomisation was done by a computer-generated random code with an interactive web response system with stratification by site. Participants, investigators, the trial leadership, and all other personnel were masked to treatment allocation until the trial was completed and the database was locked. During the treatment period, participants in both groups were instructed to inject study drug on the same day at around the same time, each week. Strokes were categorised as fatal or non-fatal, and as either ischaemic, haemorrhagic, or undetermined. Stroke severity was assessed using the modified Rankin scale. Participants were seen at 2 weeks, 3 months, 6 months, and then every 3 months for drug dispensing and every 6 months for detailed assessments, until 1200 confirmed primary outcomes accrued. The primary endpoint was the first occurrence of any component of the composite outcome, which comprised non-fatal myocardial infarction, non-fatal stroke, or death from cardiovascular or unknown causes. All analyses were done according to an intention-to-treat strategy that included all randomly assigned participants, irrespective of adherence. The trial is registered with ClinicalTrials.gov, number NCT01394952. FINDINGS Between Aug 18, 2011, and Aug 14, 2013, we screened 12 133 patients, of whom 9901 with type 2 diabetes and additional cardiovascular risk factors were randomly assigned to either dulaglutide (n=4949) or an equal volume of placebo (n=4952). During a median follow-up of 5·4 years, cerebrovascular and other cardiovascular outcomes were ascertained and adjudicated. 158 (3·2%) of 4949 participants assigned to dulaglutide and 205 (4·1%) of 4952 participants assigned to placebo had a stroke during follow-up (hazard ratio [HR] 0·76, 95% CI 0·62-0·94; p=0·010). Dulaglutide reduced ischaemic stroke (0·75, 0·59-0·94, p=0·012) but had no effect on haemorrhagic stroke (1·05, 0·55-1·99; p=0·89). Dulaglutide also reduced the composite of non-fatal stroke or all-cause death (0·88, 0·79-0·98; p=0·017) and disabling stroke (0·74, 0·56-0·99; p=0·042). The degree of disability after stroke did not differ by treatment group. INTERPRETATION Long-term dulaglutide use might reduce clinically relevant ischaemic stroke in people with type 2 diabetes but does not affect stroke severity. FUNDING Eli Lilly and Company.",2020,"Dulaglutide reduced ischaemic stroke (0·75, 0·59-0·94, p=0·012) but had no effect on haemorrhagic stroke (1·05, 0·55-1·99; p=0·89).","['158 (3·2%) of 4949 participants assigned to dulaglutide and 205 (4·1%) of 4952 participants assigned to', 'Between Aug 18, 2011, and Aug 14, 2013, we screened 12\u2008133 patients, of whom 9901 with type 2 diabetes and additional cardiovascular risk factors', '371 sites in 24 countries', 'people with type 2 diabetes', 'Men and women (aged ≥50 years) with established or newly detected type 2 diabetes whose HbA 1c was 9·5% or less (with no lower limit) on stable doses of up to two oral glucose-lowering drugs with or without basal insulin therapy were eligible if their body-mass index was at least 23 kg/m 2 ']","['dulaglutide', 'dulaglutide (n=4949) or an equal volume of placebo', 'placebo', 'masked dulaglutide 1·5 mg or the same volume of masked placebo']","['stroke', 'first occurrence of any component of the composite outcome, which comprised non-fatal myocardial infarction, non-fatal stroke, or death from cardiovascular or unknown causes', 'composite of non-fatal stroke', 'Stroke severity', 'haemorrhagic stroke', 'Dulaglutide reduced ischaemic stroke', 'degree of disability after stroke', 'disabling stroke']","[{'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C3179549', 'cui_str': 'dulaglutide'}, {'cui': 'C4517563', 'cui_str': '133'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0443211', 'cui_str': 'Established (qualifier value)'}, {'cui': 'C0442726', 'cui_str': 'Detected (qualifier value)'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0439801', 'cui_str': 'Limited (qualifier value)'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0205112', 'cui_str': 'Basal (qualifier value)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C3179549', 'cui_str': 'dulaglutide'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0024861', 'cui_str': 'Masks'}]","[{'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0439673', 'cui_str': 'Unknown (qualifier value)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0553692', 'cui_str': 'Haematencephalon'}, {'cui': 'C3179549', 'cui_str': 'dulaglutide'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}]",4949.0,0.730745,"Dulaglutide reduced ischaemic stroke (0·75, 0·59-0·94, p=0·012) but had no effect on haemorrhagic stroke (1·05, 0·55-1·99; p=0·89).","[{'ForeName': 'Hertzel C', 'Initials': 'HC', 'LastName': 'Gerstein', 'Affiliation': 'Population Health Research Institute, Hamilton, ON, Canada; Department of Medicine, McMaster University and Hamilton Health Sciences, Hamilton, ON, Canada. Electronic address: gerstein@mcmaster.ca.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Hart', 'Affiliation': 'Population Health Research Institute, Hamilton, ON, Canada.'}, {'ForeName': 'Helen M', 'Initials': 'HM', 'LastName': 'Colhoun', 'Affiliation': 'University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Diaz', 'Affiliation': 'Estudios Clínicos Latino América, Rosario, Argentina.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Lakshmanan', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Fady T', 'Initials': 'FT', 'LastName': 'Botros', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Probstfield', 'Affiliation': 'Department of Medicine, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Matthew C', 'Initials': 'MC', 'LastName': 'Riddle', 'Affiliation': 'Department of Medicine, Oregon Health & Science University Portland, OR, USA.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Rydén', 'Affiliation': 'Department of Medicine K2, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Charles Messan', 'Initials': 'CM', 'LastName': 'Atisso', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Leanne', 'Initials': 'L', 'LastName': 'Dyal', 'Affiliation': 'Population Health Research Institute, Hamilton, ON, Canada.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Hall', 'Affiliation': 'Population Health Research Institute, Hamilton, ON, Canada.'}, {'ForeName': 'Alvaro', 'Initials': 'A', 'LastName': 'Avezum', 'Affiliation': 'Hospital Alemão Oswaldo Cruz, São Paulo, Brazil.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Basile', 'Affiliation': 'Medical University of South Carolina, Ralph H Johnson VA Medical Center, Charleston, SC, USA.'}, {'ForeName': 'Ignacio', 'Initials': 'I', 'LastName': 'Conget', 'Affiliation': 'Endocrinology and Nutrition Department, Hospital Clínic i Universitari, Barcelona, Spain.'}, {'ForeName': 'William C', 'Initials': 'WC', 'LastName': 'Cushman', 'Affiliation': 'Memphis Veterans Affairs Medical Center, Memphis, TN, USA.'}, {'ForeName': 'Nicolae', 'Initials': 'N', 'LastName': 'Hancu', 'Affiliation': 'Department of Diabetes and Nutrition, Iuliu Hatieganu University of Medicine and Pharmacy, Cluj Napoca, Romania.'}, {'ForeName': 'Markolf', 'Initials': 'M', 'LastName': 'Hanefeld', 'Affiliation': 'Department of Internal Medicine, Dresden Technical University, Dresden, Germany.'}, {'ForeName': 'Petr', 'Initials': 'P', 'LastName': 'Jansky', 'Affiliation': 'University Hospital Motol, Prague, Czech Republic.'}, {'ForeName': 'Matyas', 'Initials': 'M', 'LastName': 'Keltai', 'Affiliation': 'Hungarian Institute of Cardiology, Semmelweis University, Budapest, Hungary.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Lanas', 'Affiliation': 'Department of Internal Medicine, Universidad de La Frontera, Temuco, Chile.'}, {'ForeName': 'Lawrence A', 'Initials': 'LA', 'LastName': 'Leiter', 'Affiliation': ""Li Ka Shing Knowledge Institute, St Michael's Hospital, University of Toronto, Toronto, ON, Canada.""}, {'ForeName': 'Patricio', 'Initials': 'P', 'LastName': 'Lopez-Jaramillo', 'Affiliation': 'Masira Research Institute, Medical School, Universidad de Santander UDES and FOSCAL, Bucaramanga, Colombia.'}, {'ForeName': 'Ernesto Germán Cardona', 'Initials': 'EGC', 'LastName': 'Muñoz', 'Affiliation': 'University Center of Health Sciences, Universidad de Guadalajara, Guadalajara, Mexico.'}, {'ForeName': 'Nana', 'Initials': 'N', 'LastName': 'Pogosova', 'Affiliation': 'National Medical Research Center of Cardiology, Moscow, Russia.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Raubenheimer', 'Affiliation': 'Department of Medicine, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Jonathan E', 'Initials': 'JE', 'LastName': 'Shaw', 'Affiliation': 'Baker Heart and Diabetes Institute, Melbourne, VIC, Australia.'}, {'ForeName': 'Wayne H-H', 'Initials': 'WH', 'LastName': 'Sheu', 'Affiliation': 'Taichung Veterans General Hospital, Taichung, Taiwan.'}, {'ForeName': 'Theodora', 'Initials': 'T', 'LastName': 'Temelkova-Kurktschiev', 'Affiliation': 'Robert Koch Medical Center, Sofia, Bulgaria.'}]",The lancet. Diabetes & endocrinology,['10.1016/S2213-8587(19)30423-1'] 849,30579569,Altered immunogenicity of 23-valent pneumococcal polysaccharide vaccine in elderly patients with diabetes who revealed lower responses to concomitant administration of BIKEN varicella zoster vaccine: Results of post hoc analysis of a randomized double-blind trial.,"AIMS This double-blind randomized controlled study of 52 elderly patients with diabetes assessed cell-mediated immunity and safety of BIKEN varicella-zoster vaccine (BVZV). Cellular and humoral responses to VZV at 3 months after BVZV and 23-valent polysaccharide pneumococcal vaccine (PPSV23) vaccination elicited poor results. Post-hoc analyses assessed the effects of immunogenicity of PPSV23. METHODS Using standardized enzyme-linked immunosorbent assay, pneumococcal 6B and 23F serotype-specific immunoglobulin G (IgG)-binding antibody concentrations were measured in stored samples retrospectively before administration and 3 months after. Responders increased more than twofold in at least one serotype-specific IgG. RESULTS The geometric mean concentration ratio (GMCR) of serum anti-pneumococcal 6B IgG was 1.76 (95%C.I.: 0.58, 5.34) in patients receiving concurrent PPSV23 and BVZV, compared to 2.39 (95%C.I.: 0.53, 10.76) in patients receiving PPSV23 and placebo (P = .055). The GMCR of serum anti-pneumococcal 23F IgG was 2.54 (95%C.I.: 0.57, 11.43) in PPSV23/BVZV vaccinees compared to 3.34 (95%C.I.: 0.84, 12.92) in PPSV23/placebo vaccinees (P = .424). Responder rates, those who developed antibodies to either/both serotypes, were 68% in the BVZV group and 85% in the placebo group (P = .007). CONCLUSIONS Results suggest that concurrent administration of BVZV influenced humoral responses to PPSV23 in elderly subjects with diabetes.",2019,"The GMCR of serum anti-pneumococcal 23F IgG was 2.54 (95%C.I.: 0.57, 11.43) in PPSV23/BVZV vaccinees compared to 3.34 (95%C.I.: 0.84, 12.92) in PPSV23/placebo vaccinees (P = .424).","['52 elderly patients with diabetes assessed cell-mediated immunity and safety of BIKEN varicella-zoster vaccine (BVZV', 'elderly patients with diabetes who revealed lower responses to concomitant administration of BIKEN varicella zoster vaccine', 'elderly subjects with diabetes']","['23-valent pneumococcal polysaccharide vaccine', 'placebo', 'standardized enzyme-linked immunosorbent assay, pneumococcal 6B and 23F serotype-specific immunoglobulin G', 'BVZV', 'polysaccharide pneumococcal vaccine (PPSV23) vaccination']","['geometric mean concentration ratio (GMCR) of serum anti-pneumococcal 6B IgG', 'humoral responses', 'Responder rates', 'GMCR of serum anti-pneumococcal 23F IgG', 'Cellular and humoral responses']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0020966', 'cui_str': 'Cell-Mediated Immunity'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1319755', 'cui_str': 'Varicella-zoster vaccine'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0443289', 'cui_str': 'Revealed (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous (qualifier value)'}, {'cui': 'C1533734', 'cui_str': 'Administration'}]","[{'cui': 'C0305065', 'cui_str': 'Pneumococcal Polysaccharide Vaccine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0014441', 'cui_str': 'ELISA'}, {'cui': 'C0449550', 'cui_str': 'Serotype (UK)'}, {'cui': 'C0358334', 'cui_str': 'Specific immunoglobulins'}, {'cui': 'C0032594', 'cui_str': 'Glycans'}, {'cui': 'C0358314', 'cui_str': 'Pneumococcal vaccine (substance)'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}]",52.0,0.54022,"The GMCR of serum anti-pneumococcal 23F IgG was 2.54 (95%C.I.: 0.57, 11.43) in PPSV23/BVZV vaccinees compared to 3.34 (95%C.I.: 0.84, 12.92) in PPSV23/placebo vaccinees (P = .424).","[{'ForeName': 'Atsuko', 'Initials': 'A', 'LastName': 'Hata', 'Affiliation': 'Department of Infectious Diseases, Kitano Hospital, The Tazuke Kofukai Medical Research Institute, Osaka, Japan. Electronic address: ahata@kitano-hp.or.jp.'}, {'ForeName': 'Taisei', 'Initials': 'T', 'LastName': 'Ishioka', 'Affiliation': 'Environmental Hygiene Division, Takasaki General Public Health Center, 5-28 Takamatsucho, Takasaki, Gunma 370-0829, Japan.'}, {'ForeName': 'Kazunori', 'Initials': 'K', 'LastName': 'Oishi', 'Affiliation': 'Infectious Disease Surveillance Center, National Institute of Infectious Diseases, 1-23-1 Toyama Shinjuku-ku, Tokyo 162-8640, Japan.'}, {'ForeName': 'Toshiro', 'Initials': 'T', 'LastName': 'Katayama', 'Affiliation': 'Department of Engineering, Faculty of Health Sciences, Morinomiya University of Medical Sciences, 1-26-16 Nankokita Suminoe-ku, Osaka 559-8611, Japan.'}, {'ForeName': 'Takayoshi', 'Initials': 'T', 'LastName': 'Ohkubo', 'Affiliation': 'Department of Hygiene and Public Health, Teikyo University School of Medicine, 2-11-1 Kaga Itabashi-ku, Tokyo 173-8605, Japan.'}]",Journal of diabetes and its complications,['10.1016/j.jdiacomp.2018.11.003'] 850,30600137,Efficacy and tolerability of exenatide once weekly over 7 years in patients with type 2 diabetes: An open-label extension of the DURATION-1 study.,"AIMS To investigate the glycemic efficacy, effects on cardiovascular risk factors, and safety of exenatide once weekly (QW) in patients with type 2 diabetes over 7 years in the DURATION-1 study. METHODS Patients were initially randomized to exenatide QW 2 mg or exenatide twice daily for 30 weeks, after which they received open-label, open-ended treatment with exenatide QW 2 mg for up to 7 years. Efficacy analyses included changes from baseline in glycated hemoglobin (HbA 1C ) and cardiovascular risk factors. RESULTS Of 295 patients in the intention-to-treat population, 122 (41%) completed 7 years of treatment. Patients in the 7-year completer population showed sustained glycemic improvements from baseline (7-year least-squares mean [LSM] change in HbA 1C , -1.53%) and significant improvements in several cardiovascular risk factors, including body weight, diastolic blood pressure, total cholesterol, low-density lipoprotein cholesterol, and high-density lipoprotein cholesterol. Seven-year completers who received no additional glucose-lowering therapies (n = 65 [53%]) had similar improvements in HbA 1C, and numerically greater reductions in body weight (7-year LSM change, -6.46 kg vs -3.87 kg), compared with the overall cohort. There were no unexpected safety findings. CONCLUSIONS Treatment with exenatide QW for 7 years was associated with sustained improvements in glycemic control and several cardiovascular risk factors.",2019,"There were no unexpected safety findings. ","['295 patients in the intention-to-treat population, 122 (41%) completed 7\u202fyears of treatment', 'Patients', 'patients with type 2 diabetes', 'patients with type 2 diabetes over 7\u202fyears in the DURATION-1 study']","['exenatide QW', 'exenatide', 'exenatide once weekly (QW', 'open-label, open-ended treatment with exenatide QW', 'exenatide QW 2\u202fmg or exenatide']","['glycated hemoglobin (HbA 1C ) and cardiovascular risk factors', 'cardiovascular risk factors, and safety', 'glycemic control and several cardiovascular risk factors', 'several cardiovascular risk factors, including body weight, diastolic blood pressure, total cholesterol, low-density lipoprotein cholesterol, and high-density lipoprotein cholesterol', 'glycemic efficacy', 'Efficacy and tolerability', 'body weight', 'sustained glycemic improvements']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0167117', 'cui_str': 'exenatide'}, {'cui': 'C0558293', 'cui_str': 'Once a week (qualifier value)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0023822', 'cui_str': 'High Density Lipoprotein Cholesterol'}]",,0.0302685,"There were no unexpected safety findings. ","[{'ForeName': 'Athena', 'Initials': 'A', 'LastName': 'Philis-Tsimikas', 'Affiliation': 'Scripps Whittier Diabetes Institute, La Jolla, CA, USA. Electronic address: philis-tsimikas.athena@scrippshealth.org.'}, {'ForeName': 'Carol H', 'Initials': 'CH', 'LastName': 'Wysham', 'Affiliation': 'Rockwood Clinic, Spokane, WA, USA.'}, {'ForeName': 'Elise', 'Initials': 'E', 'LastName': 'Hardy', 'Affiliation': 'AstraZeneca, Gaithersburg, MD, USA.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Han', 'Affiliation': 'Pharmapace, San Diego, CA, USA.'}, {'ForeName': 'Nayyar', 'Initials': 'N', 'LastName': 'Iqbal', 'Affiliation': 'AstraZeneca, Gaithersburg, MD, USA.'}]",Journal of diabetes and its complications,['10.1016/j.jdiacomp.2018.11.012'] 851,31523848,Repeat Annual Colorectal Cancer Screening in Rural Community Clinics: A Randomized Clinical Trial to Evaluate Outreach Strategies to Sustain Screening.,"PURPOSE The majority of colorectal cancer (CRC) research using the fecal immunochemical test (FIT) has studied short-term screening results in predominantly urban areas. The purpose of this study was to evaluate the effectiveness of 2 outreach strategies embedded in a health literacy intervention on repeat CRC screening in rural community clinics. METHODS A 2-arm randomized controlled trial was conducted in 4 rural clinics in Louisiana. During a regularly scheduled clinic visit, participants ages 50-75 received a FIT kit and brief educational intervention. Participants were randomized to receive an automated call or a personal call by a prevention counselor after 4 weeks and 8 weeks if FIT kits were not returned. In year 2, materials were mailed, and follow-up calls were conducted as in year 1. The primary outcome was repeat FIT-the return of the FIT kit in both years. PARTICIPANTS Of 568 eligible participants, 55% were female, 67% were African American, and 39% had low health literacy. FINDINGS Repeat FIT rates were 36.5% for those receiving the automated call and 33.6% for those receiving a personal call (P = .30). No annual FITs were returned in 30% of participants, while only 1 FIT was returned by 35% of participants (31% only year 1 and 4% only year 2). CONCLUSION Sustaining CRC screening with FIT is challenging in rural clinics. A lower cost automated call was just as effective as the personal call in promoting repeat annual screening. However, more intensive strategies are needed to improve long-term FIT screening among rural participants.",2020,Participants were randomized to receive an automated call or a personal call by a prevention counselor after 4 weeks and 8 weeks if FIT kits were not returned.,"['rural community clinics', '4 rural clinics in Louisiana', 'rural participants', 'Of 568 eligible participants, 55% were female, 67% were African American, and 39% had low health literacy', 'Rural Community Clinics']","['automated call or a personal call by a prevention counselor', 'health literacy intervention', 'FIT kit and brief educational intervention']","['annual FITs', 'repeat FIT-the return of the FIT kit in both years']","[{'cui': 'C0086944', 'cui_str': 'Rural Communities'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0024024', 'cui_str': 'Louisiana'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C2362527', 'cui_str': 'Health Literacy'}]","[{'cui': 'C0205554', 'cui_str': 'Automated (qualifier value)'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C1571885', 'cui_str': 'Counselors'}, {'cui': 'C2362527', 'cui_str': 'Health Literacy'}, {'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C1690540', 'cui_str': 'Kit'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}]","[{'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}, {'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C1690540', 'cui_str': 'Kit'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]",568.0,0.0671545,Participants were randomized to receive an automated call or a personal call by a prevention counselor after 4 weeks and 8 weeks if FIT kits were not returned.,"[{'ForeName': 'Terry C', 'Initials': 'TC', 'LastName': 'Davis', 'Affiliation': 'Department of Medicine, Louisiana State University Health Sciences Center, Shreveport, Louisiana.'}, {'ForeName': 'Alfred', 'Initials': 'A', 'LastName': 'Rademaker', 'Affiliation': 'Department of Preventive Medicine and the Robert H. Lurie Comprehensive Cancer Center, Northwestern University, Chicago, Illinois.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Morris', 'Affiliation': 'Department of Medicine, Louisiana State University Health Sciences Center, Shreveport, Louisiana.'}, {'ForeName': 'Laurie Anne', 'Initials': 'LA', 'LastName': 'Ferguson', 'Affiliation': 'College of Nursing and Health, Loyola University, New Orleans, Louisiana.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Wiltz', 'Affiliation': 'Teche Action Clinic, Franklin, Louisiana.'}, {'ForeName': 'Connie L', 'Initials': 'CL', 'LastName': 'Arnold', 'Affiliation': 'Department of Medicine, Louisiana State University Health Sciences Center, Shreveport, Louisiana.'}]",The Journal of rural health : official journal of the American Rural Health Association and the National Rural Health Care Association,['10.1111/jrh.12399'] 852,31837050,Efficacy of SM-1 in a transient insomnia model.,"OBJECTIVES The objectives of this study were primarily to assess the efficacy and safety of SM-1 in a circadian challenge model of transient insomnia and secondarily, to assess the contribution of diphenhydramine to the combination. METHODS Randomized, double-blind, placebo-controlled three-way cross-over study with a 5-hr phase advance. Subjects were 39 healthy adults reporting a history of transient insomnia. All treatments (SM-1, SM-1 without diphenhydramine, or placebo) were administered to all subjects in a randomly assigned sequence, with at least 1 week between treatments. The primary endpoint was total sleep time (TST) determined by polysomnography. Secondary endpoints included wakefulness after sleep onset (WASO), latency to persistent sleep, number of awakenings (NAW), subjective TST (sTST) and sleep latency (sSL), TST, and NAW by quarters of the night and sleep quality. Safety endpoints included adverse events, Karolinska Sleepiness Scale digit symbol substitution test, and subject-reported alertness level. RESULTS SM-1 provided an increase of 126.7 min in TST over placebo (p < .001). WASO, sTST, sleep quality, and sSL also showed significant improvement. Diphenhydramine demonstrated a significant (p = .014) contribution of 43.7 min to TST. SM-1 was well-tolerated with type and frequency of adverse events comparable with placebo, and no residual sleepiness upon awakening after 8 hr. CONCLUSIONS SM-1 provided a robust and statistically significant increase in TST compared with placebo in a circadian model of transient insomnia, without evidence of next-day impairment. Diphenhydramine contributed to the effect.",2019,"RESULTS SM-1 provided an increase of 126.7 min in TST over placebo (p < .001).",['Subjects were 39 healthy adults reporting a history of transient insomnia'],"['diphenhydramine, or placebo', 'SM-1', 'placebo', 'diphenhydramine', 'Diphenhydramine']","['adverse events, Karolinska Sleepiness Scale digit symbol substitution test, and subject-reported alertness level', 'TST', 'WASO, sTST, sleep quality, and sSL', 'total sleep time (TST', 'wakefulness after sleep onset (WASO), latency to persistent sleep, number of awakenings (NAW), subjective TST (sTST) and sleep latency (sSL), TST, and NAW by quarters of the night and sleep quality']","[{'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0393759', 'cui_str': 'Transient Insomnia'}]","[{'cui': 'C0012522', 'cui_str': 'Diphenhydramine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C2830004', 'cui_str': 'Somnolence'}, {'cui': 'C0222045'}, {'cui': 'C0582802', 'cui_str': 'Digit'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0043012', 'cui_str': 'Wakefulnesses'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1720052', 'cui_str': 'Awakening'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C4505222', 'cui_str': 'REM Sleep Latency'}]",39.0,0.262737,"RESULTS SM-1 provided an increase of 126.7 min in TST over placebo (p < .001).","[{'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Dahl', 'Affiliation': 'Sequential Medicine Ltd, Taipei, Taiwan.'}, {'ForeName': 'Lan Bo', 'Initials': 'LB', 'LastName': 'Chen', 'Affiliation': 'Sequential Medicine Ltd, Taipei, Taiwan.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Zammit', 'Affiliation': 'Clinilabs Drug Development Corporation, New York, New York.'}, {'ForeName': 'Maha', 'Initials': 'M', 'LastName': 'Ahmad', 'Affiliation': 'Clinilabs Drug Development Corporation, New York, New York.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Roth', 'Affiliation': 'Sleep Disorders and Research, Henry Ford Hospital Sleep Disorders Center, Detroit, Michigan.'}]",Human psychopharmacology,['10.1002/hup.2713'] 853,31774584,"5-HT 2c agonist, lorcaserin, reduces aggressive responding in intermittent explosive disorder: A pilot study.","RATIONALE Impulsive aggressive behavior is associated with reduced central function of serotonin (5-HT). Although selective serotonin reuptake inhibitors can reduce such behaviors, many with history of impulsive aggression do not respond adequately to selective serotonin reuptake inhibitors and may require treatment with a direct 5-HT agonist. OBJECTIVES To test the hypothesis that pretreatment with the selective 5-HT2c agonist, lorcaserin, can reduce aggressive responding in impulsively aggressive individuals. METHODS Ten male and female adults were given lorcaserin (20 mg), or a matching placebo, in random order, on 2 days separated by at least 1 week. The Taylor aggression paradigm was used to assess aggressive responding, which was represented by mean shock setting administered to an opponent and by frequency of setting high and extreme shock levels to the opponent. RESULTS Compared with placebo, lorcaserin attenuated provoked, but not unprovoked, aggression during the Taylor aggression paradigm. This was manifest by reduction in the frequency of selecting high and extreme levels of shock against the opponent. CONCLUSION Lorcaserin may possess anti-aggressive properties that could prove useful in the treatment of impulsive aggressive behavior in human subjects. These data, thus, provide a rationale for a follow-up randomized clinical trial of lorcaserin in individuals with prominent histories of impulsive aggressive behavior.",2019,"Compared with placebo, lorcaserin attenuated provoked, but not unprovoked, aggression during the Taylor aggression paradigm.","['Ten male and female adults', 'individuals with prominent histories of impulsive aggressive behavior', 'human subjects', 'intermittent explosive disorder']","['Lorcaserin', 'lorcaserin', 'matching placebo', 'placebo, lorcaserin', '5-HT 2c agonist, lorcaserin']",[],"[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0205402', 'cui_str': 'Prominent (qualifier value)'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0001807', 'cui_str': 'Aggression'}, {'cui': 'C0080105', 'cui_str': 'Human Subjects'}, {'cui': 'C0021776', 'cui_str': 'Intermittent Explosive Disorder'}]","[{'cui': 'C2350948', 'cui_str': 'lorcaserin'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0036751', 'cui_str': 'Serotonin'}, {'cui': 'C0243192', 'cui_str': 'agonists'}]",[],10.0,0.148608,"Compared with placebo, lorcaserin attenuated provoked, but not unprovoked, aggression during the Taylor aggression paradigm.","[{'ForeName': 'Emil F', 'Initials': 'EF', 'LastName': 'Coccaro', 'Affiliation': 'Clinical Neuroscience Research Unit, Department of Psychiatry and Behavioral Neuroscience, Pritzker School of Medicine, The University of Chicago, Chicago, Illinois.'}, {'ForeName': 'Royce J', 'Initials': 'RJ', 'LastName': 'Lee', 'Affiliation': 'Clinical Neuroscience Research Unit, Department of Psychiatry and Behavioral Neuroscience, Pritzker School of Medicine, The University of Chicago, Chicago, Illinois.'}]",Human psychopharmacology,['10.1002/hup.2714'] 854,31907022,Comparing how patients value and respond to information on risk given in three different forms during dental check-ups: the PREFER randomised controlled trial.,"BACKGROUND This study aims to compare patient preference for, and subsequent change in, oral health behaviour for three forms of risk information given at dental check-ups (verbal advice compared to verbal advice accompanied by a traffic light (TL) risk card; or compared to verbal advice with a quantitative light fluorescence (QLF) photograph of the patient's mouth). METHODS A multi-centre, parallel-group, patient-randomised clinical trial was undertaken between August 2015 and September 2016. Computer-generated random numbers using block stratification allocated patients to three arms. The setting was four English NHS dental practices. Participants were 412 dentate adults at medium/high risk of poor oral health. Patients rated preference and willingness to pay (WTP) for the three types of information. The primary outcome was WTP. After receiving their check-up, patients received the type of information according to their group allocation. Follow-up was by telephone/e-mail at 6 and 12 months. Mean and median WTP for the three arms were compared using Wilcoxon signed-rank tests. Tobit regression models were used to investigate factors affecting WTP and preference for information type. Secondary outcomes included self-rated oral health and change in oral health behaviours (tooth-brushing, sugar consumption and smoking) and were investigated using multivariate generalised linear mixed models. RESULTS A total of 412 patients were randomised (138 to verbal, 134 to TL and 140 to QLF); 391 revisited their WTP scores after the check-up (23 withdrew). Follow-up data were obtained for 185 (46%) participants at 6 months and 153 (38%) participants at 12 months. Verbal advice was the first preference for 51% (209 participants), QLF for 35% (145 participants) and TL for 14% (58 participants). TL information was valued lower than either verbal or QLF information (p < 0.0001). Practice attended was predictive of verbal as first preference, and being older. Practice attended, preferring TL the most and having fewer than 20 teeth were associated with increased WTP; and living in a relatively deprived area or having low literacy decreased WTP. There were no significant differences in behaviour change on follow-up. CONCLUSIONS Although a new NHS dental contract based on TL risk stratification is being tested, patients prefer the usual verbal advice. There was also a practice effect which will needs to be considered for successful implementation of this government policy. TRIAL REGISTRATION ISRCTN, ISRCTN71242343. Retrospectively registered on 27 March 2018.",2020,TL information was valued lower than either verbal or QLF information (p < 0.0001).,"['Participants were 412 dentate adults at medium/high risk of poor oral health', 'A multi-centre', ""of the patient's mouth"", '412 patients were randomised (138 to verbal, 134 to TL and 140 to QLF); 391 revisited their WTP scores after the check-up (23 withdrew']",['dental check-ups (verbal advice compared to verbal advice accompanied by a traffic light (TL) risk card; or compared to verbal advice with a quantitative light fluorescence (QLF) photograph'],"['preference and willingness to pay (WTP', 'Mean and median WTP', 'self-rated oral health and change in oral health behaviours (tooth-brushing, sugar consumption and smoking', 'increased WTP', 'behaviour change', 'Verbal advice', 'TL information']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439536', 'cui_str': 'Medium (qualifier value)'}, {'cui': 'C0332167', 'cui_str': 'High risk of (contextual qualifier) (qualifier value)'}, {'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C0029162'}, {'cui': 'C3266262', 'cui_str': 'Multi'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0230028', 'cui_str': 'Structure of oral region of face'}, {'cui': 'C0439824', 'cui_str': 'Verbal (qualifier value)'}, {'cui': 'C4517565', 'cui_str': 'One hundred and thirty-four'}, {'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0231290', 'cui_str': 'Status post (contextual qualifier) (qualifier value)'}, {'cui': 'C0424092', 'cui_str': 'Withdrawn (finding)'}]","[{'cui': 'C4522313', 'cui_str': 'Dental (intended site)'}, {'cui': 'C0439824', 'cui_str': 'Verbal (qualifier value)'}, {'cui': 'C0442664', 'cui_str': 'Traffic light (physical object)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0392762', 'cui_str': 'Quantitative (qualifier value)'}, {'cui': 'C0332264', 'cui_str': 'Light (weight) (qualifier value)'}, {'cui': 'C0016315', 'cui_str': 'Fluorescence'}, {'cui': 'C0441468', 'cui_str': 'Photograph (physical object)'}]","[{'cui': 'C0558295', 'cui_str': 'Preferences (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0029162'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0040426', 'cui_str': 'Tooth'}, {'cui': 'C0242209', 'cui_str': 'Sugars'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0439824', 'cui_str': 'Verbal (qualifier value)'}]",209.0,0.194128,TL information was valued lower than either verbal or QLF information (p < 0.0001).,"[{'ForeName': 'R', 'Initials': 'R', 'LastName': 'Harris', 'Affiliation': 'Department of Health Services Research, Institute of Population Health Sciences, University of Liverpool, Room 124, 1st Floor Block B, Waterhouse Building, 1-5 Brownlow Hill, Liverpool, L69 3GL, UK. harrisrv@liverpool.ac.uk.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Lowers', 'Affiliation': 'Department of Health Services Research, Institute of Population Health Sciences, University of Liverpool, Room 124, 1st Floor Block B, Waterhouse Building, 1-5 Brownlow Hill, Liverpool, L69 3GL, UK.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Laverty', 'Affiliation': 'Department of Health Services Research, Institute of Population Health Sciences, University of Liverpool, Room 124, 1st Floor Block B, Waterhouse Building, 1-5 Brownlow Hill, Liverpool, L69 3GL, UK.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Vernazza', 'Affiliation': 'School of Dental Sciences, Newcastle University, Newcastle-upon-Tyne, Tyne and Wear, UK.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Burnside', 'Affiliation': 'Department of Biostatistics, Institute of Translational Medicine, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Brown', 'Affiliation': 'Department of Health Services Research, Institute of Population Health Sciences, University of Liverpool, Room 124, 1st Floor Block B, Waterhouse Building, 1-5 Brownlow Hill, Liverpool, L69 3GL, UK.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Ternent', 'Affiliation': 'Institute of Health and Society, Newcastle University, Newcastle-upon-Tyne, Tyne and Wear, UK.'}]",Trials,['10.1186/s13063-019-3824-3'] 855,31578781,Does Listening to Music Regulate Negative Affect in a Stressful Situation? Examining the Effects of Self-Selected and Researcher-Selected Music Using Both Silent and Active Controls.,"BACKGROUND Stress and anxiety are increasingly common among young people. The current research describes two studies comparing the effects of self-selected and researcher-selected music on induced negative affect (state anxiety and physiological arousal), and state mindfulness. METHOD In Study 1, 70 undergraduates were randomly assigned to one of three conditions: researcher-selected music, self-selected music, or a silent control condition. In Study 2, with 75 undergraduates, effects of music were compared to an active control (listening to a radio show). Negative affect was induced using a speech preparation and arithmetic task, followed by music listening or control. Self-reported anxiety and blood pressure were measured at baseline, post-induction, and post-intervention. Study 2 included state mindfulness as a dependent measure. RESULTS Study 1 indicated that participants who listened to music (self-selected and researcher-selected) reported significantly greater anxiety reduction than participants in the silent control condition. Music did not reduce anxiety compared to an active control in Study 2. However, music listening significantly increased levels of state mindfulness, which predicted lower anxiety after self-selected music listening. CONCLUSIONS Music may provide regulation in preparation for stressful events. Yet, the results of Study 2 indicate that other activities have similar benefits, and shows, for the first time, that music listening increases mindfulness following a stressor.",2019,Music did not reduce anxiety compared to an active control in Study 2.,"['70 undergraduates', 'young people']","['Self-Selected and Researcher-Selected Music Using Both Silent and Active Controls', 'active control (listening to a radio show', 'music listening', 'researcher-selected music, self-selected music, or a silent control condition', 'self-selected and researcher-selected music']","['Self-reported anxiety and blood pressure', 'anxiety reduction', 'anxiety', 'levels of state mindfulness']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0035173', 'cui_str': 'Investigators'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0443304', 'cui_str': 'Silent (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0004339', 'cui_str': 'Auscultation'}, {'cui': 'C0034546', 'cui_str': 'Radio'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0150135', 'cui_str': 'Reducing anxiety'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C3542996', 'cui_str': 'Mindfulness'}]",2.0,0.0636066,Music did not reduce anxiety compared to an active control in Study 2.,"[{'ForeName': 'Jenny M', 'Initials': 'JM', 'LastName': 'Groarke', 'Affiliation': ""Queen's University Belfast, Belfast, UK.""}, {'ForeName': 'AnnMarie', 'Initials': 'A', 'LastName': 'Groarke', 'Affiliation': 'National University of Ireland, Galway, Ireland.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Hogan', 'Affiliation': 'National University of Ireland, Galway, Ireland.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Costello', 'Affiliation': 'National University of Ireland, Galway, Ireland.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Lynch', 'Affiliation': 'National University of Ireland, Galway, Ireland.'}]",Applied psychology. Health and well-being,['10.1111/aphw.12185'] 856,30626911,"A phase 2, double-blind, placebo-controlled study of NSI-189 phosphate, a neurogenic compound, among outpatients with major depressive disorder.","NSI-189 is a novel neurogenic compound independent of monoamine reuptake pathways. This trial evaluated oral NSI-189 as monotherapy in major depressive disorder. To improve signal detection, the sequential-parallel comparison design (SPCD) was chosen. Two hundred and twenty subjects were randomized to NSI-189 40 mg daily, 80 mg daily, or placebo for 12 weeks. The primary outcome measure was the Montogmery Asberg Depression Rating Scale (MADRS). Secondary subject-rated measures included the Symptoms of Depression Questionnaire (SDQ), the Cognitive and Physical Functioning Scale (CPFQ), the patient-rated version of the Quick Inventory of Depressive Symptomatology Scale (QIDS-SR), and subtests from the CogScreen and Cogstate cognitive tests. MADRS score reduction versus placebo did not reach significance for either dose (40 mg pooled mean difference -1.8, p = 0.22, 80 mg pooled mean difference -1.4, p = 0.34, respectively). However, the 40 mg dose showed greater overall reduction in SDQ (pooled mean difference -8.2; Cohen's d for Stages 1 and 2 = -0.11 and -0.64, p = 0.04), and CPFQ scores (pooled mean difference -1.9; Cohen's d for Stages 1 and 2 = -0.28 and -0.47, p = 0.03) versus placebo, as well as QIDS-SR scores in Stage 2 of SPCD (-2.5; Cohen's d Stages 1 and 2 = -0.03 and -0.68, p = 0.04). The 40 mg dose also showed advantages on some objective cognitive measures of the CogScreen (absolute Cohen's d ranged between 0.12 and 1.12 in favor of NSI-189, p values between 0.002 and 0.048 for those with overall significance), but not the Cogstate test. Both doses were well tolerated. These findings replicate those of phase 1b study, and warrant further exploration of the antidepressant and pro-cognitive effects of NSI-189.",2020,"MADRS score reduction versus placebo did not reach significance for either dose (40 mg pooled mean difference -1.8, p = 0.22, 80 mg pooled mean difference -1.4, p = 0.34, respectively).","['major depressive disorder', 'Two hundred and twenty subjects were randomized to NSI-189 40', 'outpatients with major depressive disorder']","['NSI-189 phosphate', 'NSI-189', 'placebo']","['Montogmery Asberg Depression Rating Scale (MADRS', 'MADRS score reduction', 'Symptoms of Depression Questionnaire (SDQ), the Cognitive and Physical Functioning Scale (CPFQ), the patient-rated version of the Quick Inventory of Depressive Symptomatology Scale (QIDS-SR), and subtests from the CogScreen and Cogstate cognitive tests', 'QIDS-SR scores', 'tolerated', 'overall reduction in SDQ', 'objective cognitive measures of the CogScreen', 'CPFQ scores']","[{'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C4517650', 'cui_str': '220 (qualifier value)'}, {'cui': 'C4507670', 'cui_str': 'NSI-189'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}]","[{'cui': 'C4507671', 'cui_str': 'NSI-189 phosphate'}, {'cui': 'C4507670', 'cui_str': 'NSI-189'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C4720917', 'cui_str': 'Quick inventory of depressive symptomatology (assessment scale)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}]",220.0,0.16936,"MADRS score reduction versus placebo did not reach significance for either dose (40 mg pooled mean difference -1.8, p = 0.22, 80 mg pooled mean difference -1.4, p = 0.34, respectively).","[{'ForeName': 'G I', 'Initials': 'GI', 'LastName': 'Papakostas', 'Affiliation': 'Massachusetts General Hospital Clinical Trials Network and Institute (MGH CTNI), Boston, MA, USA. gpapakostas@partners.org.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Johe', 'Affiliation': 'Neuralstem, Inc, Germantown, MD, USA.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Hand', 'Affiliation': 'Neuralstem, Inc, Germantown, MD, USA.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Drouillard', 'Affiliation': 'Neuralstem, Inc, Germantown, MD, USA.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Russo', 'Affiliation': 'Neuralstem, Inc, Germantown, MD, USA.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Kay', 'Affiliation': 'Cognitive Research Corp., Saint Petersburg, Florida, USA.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Kashambwa', 'Affiliation': 'Massachusetts General Hospital Clinical Trials Network and Institute (MGH CTNI), Boston, MA, USA.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Hoeppner', 'Affiliation': 'Massachusetts General Hospital Clinical Trials Network and Institute (MGH CTNI), Boston, MA, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Flynn', 'Affiliation': 'Massachusetts General Hospital Clinical Trials Network and Institute (MGH CTNI), Boston, MA, USA.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Yeung', 'Affiliation': 'Massachusetts General Hospital Clinical Trials Network and Institute (MGH CTNI), Boston, MA, USA.'}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Martinson', 'Affiliation': 'Massachusetts General Hospital Clinical Trials Network and Institute (MGH CTNI), Boston, MA, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Fava', 'Affiliation': 'Massachusetts General Hospital Clinical Trials Network and Institute (MGH CTNI), Boston, MA, USA.'}]",Molecular psychiatry,['10.1038/s41380-018-0334-8'] 857,31919919,"Ixekizumab improves secondary lesional signs, pain and sexual health in patients with moderate-to-severe genital psoriasis.","BACKGROUND Epithelial surface disruption in genital psoriatic lesions may manifest as erosions, fissures and/or ulcers, causing pain and significantly impacting a patient's sexual health. OBJECTIVE To evaluate the impact of erosions, fissures and/or ulcers in genital psoriatic lesions on pain and sexual activity in patients with moderate-to-severe genital psoriasis (GenPs) and treatment responses to ixekizumab vs. placebo until Week 12. METHODS This post hoc subgroup analysis of patients presenting with and without erosions, fissures and/or ulcers in genital lesions from a phase IIIb multicentre, randomized, double-blind, placebo-controlled study (IXORA-Q; NCT02718898) in 149 adults with moderate-to-severe GenPs treated with subcutaneous ixekizumab (80 mg every 2 weeks; n = 75) or placebo (n = 74) evaluated outcomes for clinician-rated GenPs severity (static Physician's Global Assessment of Genitalia; sPGA-G) and patient-reported genital pain and itch (Genital Psoriasis Symptoms Scale; GPSS) and sexual health (Genital Psoriasis Sexual Frequency Questionnaire; GenPs-SFQ). RESULTS At baseline, 38% (n = 57) of patients presented with genital erosions, fissures and/or ulcers independent of overall body surface area involvement (<10% or ≥10%). These signs were associated with higher scores for disease severity (sPGA-G) and pain (GPSS) but not sexual health (GenPs-SFQ). Complete resolution of these signs was observed in 62% of ixekizumab-treated patients (25% for placebo) at Week 1 and 83% (21% for placebo) at Week 12. Patients treated with ixekizumab reported significant improvements in pain, itch, disease severity and sexual health over 12 weeks compared to placebo and irrespective of the presence/absence of genital erosions, fissures and/or ulcers at baseline. CONCLUSION Ixekizumab led to rapid and sustained resolution of erosions, fissures and/or ulcers and significant improvements in GenPs severity, genital pain and sexual health. Ixekizumab may help to improve the well-being of patients with GenPs.",2020,"Patients treated with ixekizumab reported significant improvements in pain, itch, disease severity and sexual health over 12 weeks compared to placebo and irrespective of the presence/absence of genital erosions, fissures and/or ulcers at baseline. ","['patients with moderate-to-severe genital psoriasis', '80 mg every 2 weeks; n = 75) or', 'patients presenting with and without erosions, fissures and/or ulcers in genital lesions', '149 adults with moderate-to-severe GenPs treated with', 'patients with moderate-to-severe genital psoriasis (GenPs']","['Ixekizumab', 'ixekizumab', 'ixekizumab versus placebo', 'placebo', 'subcutaneous ixekizumab']","['secondary lesional signs, pain and sexual health', 'genital erosions, fissures and/or ulcers', 'disease severity (sPGA-G) and pain (GPSS', 'GenPs severity, genital pain and sexual health', ""clinician-rated GenPs severity (static Physician's Global Assessment of Genitalia; sPGA-G) and patient-reported genital pain and itch (Genital Psoriasis Symptoms Scale; GPSS) and sexual health (Genital Psoriasis Sexual Frequency Questionnaire; GenPs-SFQ"", 'pain, itch, disease severity and sexual health', 'Complete resolution of these signs', 'pain and sexual activity']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0017420', 'cui_str': 'Reproductive System'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0333307', 'cui_str': 'Superficial ulcer (morphologic abnormality)'}, {'cui': 'C0332469', 'cui_str': 'Fissured (qualifier value)'}, {'cui': 'C0041582', 'cui_str': 'Ulcer'}, {'cui': 'C0744369', 'cui_str': 'Lesion of genitalia'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}]","[{'cui': 'C3489764', 'cui_str': 'ixekizumab'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1522438', 'cui_str': 'SC use'}]","[{'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0311392', 'cui_str': 'Sign'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C2362326', 'cui_str': 'Sexual Health'}, {'cui': 'C1504460', 'cui_str': 'Genital erosion'}, {'cui': 'C0332469', 'cui_str': 'Fissured (qualifier value)'}, {'cui': 'C0041582', 'cui_str': 'Ulcer'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0239725', 'cui_str': 'Genital pain'}, {'cui': 'C0441463', 'cui_str': 'Static (qualifier value)'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0017420', 'cui_str': 'Reproductive System'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0033774', 'cui_str': 'Pruritis'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0222045'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0036864', 'cui_str': 'Sexual Behavior'}]",149.0,0.198098,"Patients treated with ixekizumab reported significant improvements in pain, itch, disease severity and sexual health over 12 weeks compared to placebo and irrespective of the presence/absence of genital erosions, fissures and/or ulcers at baseline. ","[{'ForeName': 'J F', 'Initials': 'JF', 'LastName': 'Merola', 'Affiliation': ""Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'P-D', 'Initials': 'PD', 'LastName': 'Ghislain', 'Affiliation': 'Department of Dermatology, Cliniques Saint-Luc, Université Catholique de Louvain, Brussels, Belgium.'}, {'ForeName': 'J N', 'Initials': 'JN', 'LastName': 'Dauendorffer', 'Affiliation': 'Department of Dermatology, Saint-Louis Hospital, Paris, France.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Potts Bleakman', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'A J M', 'Initials': 'AJM', 'LastName': 'Brnabic', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Burge', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Riedl', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}]",Journal of the European Academy of Dermatology and Venereology : JEADV,['10.1111/jdv.16181'] 858,31794072,"Pharmacodynamic and pharmacokinetic profile of SM-1, a triple-drug combination to increase total sleep time.","OBJECTIVE The primary objective was to characterize the pharmacokinetics and pharmacodynamics of SM-1 after administration of a single oral dose to healthy volunteers in a placebo-controlled double-blind trial of daytime sedation. Secondary objectives were to determine the onset, duration, and offset of the sedative effects using subjective and objective measures of sedation. Safety and tolerability of SM-1 were also investigated. METHODS Males and females 18-45 years of age received SM-1, a combination drug product comprised of diphenhydramine, zolpidem (delayed release), and lorazepam (delayed release). The pharmacokinetic profile of each drug was determined from blood samples. Sedative effects were assessed by visual analog scale, digit symbol substitution test, memory test, and quantitative electroencephalography. RESULTS Similar number and severity of adverse events were observed following administration of SM-1 and placebo. Onset of sedation, as determined by subjective, performance, and electroencephalography measures, occurred 0.5-1 hr postdose, lasting about 7-7.5 hr. Plasma concentration curves for the two delayed-release components were altered compared with published data for unmodified drugs. Exposure values obtained with the combination product were in good agreement with published values of the drugs given individually. CONCLUSIONS SM-1 was well tolerated and has pharmacologic activity starting within an hour of ingestion, lasting approximately 7-8 hr. Sedative activity was seen with subjective, psychomotor, and electroencephalography assays.",2019,Similar number and severity of adverse events were observed following administration of SM-1 and placebo.,"['Males and females 18-45 years of age received SM-1, a combination drug product comprised of', 'healthy volunteers in a placebo-controlled double-blind trial of daytime sedation']","['SM-1 and placebo', 'diphenhydramine, zolpidem (delayed release), and lorazepam', 'SM-1']","['Sedative effects', 'total sleep time', 'Sedative activity', 'visual analog scale, digit symbol substitution test, memory test, and quantitative electroencephalography', 'Plasma concentration curves', 'onset, duration, and offset of the sedative effects using subjective and objective measures of sedation', 'Safety and tolerability of SM-1', 'Similar number and severity of adverse events', 'subjective, performance, and electroencephalography measures']","[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0332169', 'cui_str': 'Daytime (qualifier value)'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0012522', 'cui_str': 'Diphenhydramine'}, {'cui': 'C0078839', 'cui_str': 'zolpidem'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0024002', 'cui_str': 'Lorazepam'}]","[{'cui': 'C3179159', 'cui_str': 'Sedative Effect'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0036557', 'cui_str': 'Sedatives'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0582802', 'cui_str': 'Digit'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0392762', 'cui_str': 'Quantitative (qualifier value)'}, {'cui': 'C0013819', 'cui_str': 'EEG'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.150366,Similar number and severity of adverse events were observed following administration of SM-1 and placebo.,"[{'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Dahl', 'Affiliation': 'Sequential Medicine Ltd, Taipei, Taiwan.'}, {'ForeName': 'Lan Bo', 'Initials': 'LB', 'LastName': 'Chen', 'Affiliation': 'Sequential Medicine Ltd, Taipei, Taiwan.'}, {'ForeName': 'Mika', 'Initials': 'M', 'LastName': 'Scheinin', 'Affiliation': 'CRST Oy, Turku, Finland.'}, {'ForeName': 'Jaana', 'Initials': 'J', 'LastName': 'Suopanki-Lalowski', 'Affiliation': 'Crown CRO Oy, Espoo, Finland.'}, {'ForeName': 'Marju', 'Initials': 'M', 'LastName': 'Valge', 'Affiliation': 'StatFinn Estonia OÜ, Tartu, Estonia.'}, {'ForeName': 'Antti', 'Initials': 'A', 'LastName': 'Puhakka', 'Affiliation': 'Suomen Neurolaboratorio Oy, Turku, Finland.'}, {'ForeName': 'Hannu', 'Initials': 'H', 'LastName': 'Mikola', 'Affiliation': 'Suomen Neurolaboratorio Oy, Turku, Finland.'}, {'ForeName': 'Zsófia', 'Initials': 'Z', 'LastName': 'Lovró', 'Affiliation': 'CRST Oy, Turku, Finland.'}, {'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Meierjohann', 'Affiliation': 'Turku University Hospital, Institute of Biomedicine, and TYKSLAB, University of Turku, Turku, Finland.'}, {'ForeName': 'Lauri', 'Initials': 'L', 'LastName': 'Vuorilehto', 'Affiliation': 'Turku University Hospital, Institute of Biomedicine, and TYKSLAB, University of Turku, Turku, Finland.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Roth', 'Affiliation': 'Sleep Disorders and Research, Henry Ford Hospital Sleep Disorders Center, Detroit, Michigan.'}]",Human psychopharmacology,['10.1002/hup.2716'] 859,31545506,An indirect comparison of long-term efficacy of every-2-week dosing vs. recommended dosing of ixekizumab in patients who had static Physician's Global Assessment > 1 at week 12.,"BACKGROUND Long-term efficacy and safety of ixekizumab [160 mg at week 0, then 80 mg every 2 weeks (Q2W) for 12 weeks, followed by every 4 weeks (Q4W) thereafter (i.e. Q2W/Q4W), which is the labelled psoriasis dosing where approved, except in Japan] have been established for the treatment of adults with moderate-to-severe plaque psoriasis. However, some patients may benefit from remaining on Q2W dosing beyond 12 weeks. METHODS Among patients who had static Physician's Global Assessment (sPGA) > 1 at week 12, efficacy through week 52 of continuous Q2W dosing in the IXORA-P study was compared indirectly with Q2W/Q4W in the integrated data from the UNCOVER-1, UNCOVER-2 and UNCOVER-3 studies. The continuous Q4W dose group, which had comparable results across studies, was used as the common comparator. RESULTS In the IXORA-P study, among patients with sPGA > 1 at week 12, 64% of patients in the continuous Q2W group achieved sPGA ≤ 1 at week 52, which was statistically significantly higher than the 36% of patients with sPGA > 1 in the Q2W/Q4W group based on the integrated data from the UNCOVER studies (P = 0·0007). There were no clinically meaningful differences in frequencies of safety events between patients with sPGA ≤ 1 and patients with sPGA > 1 at week 12 in the IXORA-P study. CONCLUSIONS Among patients who did not have clear or almost clear skin at week 12, nearly 30% more patients who were treated continuously with ixekizumab Q2W in IXORA-P had clear or almost clear skin at week 52 when compared indirectly with those who were treated using the labelled psoriasis dosing in integrated UNCOVER studies. What's already known about this topic? Most patients with moderate-to-severe psoriasis who were given the labelled psoriasis dosing of ixekizumab [160-mg loading dose at week 0, 80 mg every 2 weeks (Q2W) through week 12, and 80 mg every 4 weeks (QW4) thereafter] respond quickly with a high percentage of skin clearance. Additionally, patients who achieve static Physician's Global Assessment (sPGA) ≤ 1 by week 12 tend to maintain this response, even after switching to Q4W. What does this study add? Here, we assessed whether patients with sPGA > 1 at week 12 benefited from receiving more frequent dosing beyond the first 12 weeks. The results showed that Q2W dosing beyond 12 weeks resulted in more patients achieving sPGA ≤ 1 by week 52 than the labelled psoriasis dosing among patients with sPGA > 1 at week 12.",2020,"There were no clinically meaningful differences in frequencies of safety events between patients with sPGA≤1 and patients with sPGA>1 at Week 12 in the IXORA-P study. ","['adults with moderate-to-severe plaque psoriasis', 'patients who had sPGA>1 at week 12']","['ixekizumab', 'ixekizumab Q2W']",['frequencies of safety events'],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0406317', 'cui_str': 'Plaque psoriasis (disorder)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C3489764', 'cui_str': 'ixekizumab'}]","[{'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}]",,0.0282951,"There were no clinically meaningful differences in frequencies of safety events between patients with sPGA≤1 and patients with sPGA>1 at Week 12 in the IXORA-P study. ","[{'ForeName': 'K', 'Initials': 'K', 'LastName': 'Papp', 'Affiliation': 'K. Papp Clinical Research and Probity Medical Research, Waterloo, ON, Canada.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Maari', 'Affiliation': 'Innovaderm Research, Montreal, QC, Canada.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Cauthen', 'Affiliation': 'MidState Skin Institute, Ocala, FL, U.S.A.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Gooderham', 'Affiliation': 'SkiN Centre for Dermatology and Probity Medical Research, Peterborough, and Queens University, Kingston, ON, Canada.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Spelman', 'Affiliation': 'Veracity Clinical Research, Brisbane, Queensland, Australia.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Yamanaka', 'Affiliation': 'Department of Dermatology, Graduate School of Medicine, Mie University, Tsu, Mie, Japan.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Polzer', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, U.S.A.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, U.S.A.'}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Osuntokun', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, U.S.A.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Augustin', 'Affiliation': 'Institute for Health Services Research in Dermatology and Nursing, University Medical Center, Hamburg, Germany.'}]",The British journal of dermatology,['10.1111/bjd.18550'] 860,31545507,"Long-term efficacy and safety of sonidegib in patients with advanced basal cell carcinoma: 42-month analysis of the phase II randomized, double-blind BOLT study.","BACKGROUND Basal cell carcinomas (BCCs) exhibit aberrant activation of the hedgehog pathway. Sonidegib is a hedgehog pathway inhibitor approved for the treatment of locally advanced BCC (laBCC) and metastatic BCC (mBCC) based on primary results of the BOLT study [Basal Cell Carcinoma Outcomes with LDE225 (sonidegib) Treatment]. OBJECTIVES This is the final 42-month analysis of the BOLT study, evaluating the efficacy and safety of sonidegib. METHODS Adults with no prior hedgehog pathway inhibitor therapy were randomized in a 1 : 2 ratio to sonidegib 200 mg or 800 mg once daily. Treatment continued for up to 42 months or until disease progression, unacceptable toxicity, death, study termination or withdrawal of consent. The primary efficacy end point was the objective response rate (ORR) by central review, assessed at baseline; weeks 5, 9 and 17; then subsequently every 8 or 12 weeks during years 1 or 2, respectively. Safety end points included adverse event monitoring and reporting. RESULTS The study enrolled 230 patients, 79 and 151 in the 200-mg and 800-mg groups, respectively, of whom 8% and 3.3% remained on treatment by the 42-month cutoff, respectively. The ORRs by central review were 56% [95% confidence interval (CI) 43-68] for laBCC and 8% (95% CI 0·2-36) for mBCC in the 200-mg group and 46·1% (95% CI 37·2-55·1) for laBCC and 17% (95% CI 5-39) for mBCC in the 800-mg group. No new safety concerns emerged. CONCLUSIONS Sonidegib demonstrated sustained efficacy and a manageable safety profile. The final BOLT results support sonidegib as a viable treatment option for laBCC and mBCC. What's already known about this topic? Basal cell carcinoma (BCC) is usually treatable with surgery or radiation therapy, but there are limited treatment options for patients with advanced BCC. Sonidegib, a hedgehog pathway inhibitor approved for the treatment of advanced BCC, demonstrated clinically relevant efficacy and manageable safety in prior analyses of the phase II randomized, double-blind BOLT study [Basal Cell Carcinoma Outcomes with LDE225 (sonidegib) Treatment]. What does this study add? This final 42-month analysis of BOLT is the longest follow-up available for a hedgehog pathway inhibitor. Clinically relevant efficacy results were sustained from prior analyses, with objective response rates by central review of the approved 200-mg daily dose of 56% in locally advanced BCC and 8% in metastatic BCC. No new safety concerns were raised. The results confirmed sonidegib as a viable long-term treatment option for patients with advanced BCC.",2020,"Sonidegib is a hedgehog pathway inhibitor approved for the treatment of locally advanced BCC (laBCC) and metastatic BCC (mBCC) based on primary results of the BOLT (Basal Cell Carcinoma Outcomes with LDE225 [sonidegib] Treatment) study. ","['Adults with no prior hedgehog pathway inhibitor therapy', 'patients with advanced basal cell carcinoma', 'The study enrolled 230 patients, 79 and 151 in the 200 mg and 800 mg groups, respectively, of whom 8% and 3% remained on treatment by the 42-month cutoff, respectively']","['sonidegib 200 mg or 800 mg once daily', 'sonidegib']","['adverse event monitoring and reporting', 'unacceptable toxicity, death, study termination, or withdrawal of consent', 'objective response rate (ORR) by central review']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1265465', 'cui_str': 'Subfamily Erinaceinae'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0007117', 'cui_str': 'Epithelioma, Basal Cell'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C3844106', 'cui_str': 'Eight hundred'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C4047161', 'cui_str': 'sonidegib 200 MG'}, {'cui': 'C3844106', 'cui_str': 'Eight hundred'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}, {'cui': 'C3886731', 'cui_str': 'sonidegib'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0282443', 'cui_str': 'Review'}]",230.0,0.123833,"Sonidegib is a hedgehog pathway inhibitor approved for the treatment of locally advanced BCC (laBCC) and metastatic BCC (mBCC) based on primary results of the BOLT (Basal Cell Carcinoma Outcomes with LDE225 [sonidegib] Treatment) study. ","[{'ForeName': 'R', 'Initials': 'R', 'LastName': 'Dummer', 'Affiliation': 'Department of Dermatology, University of Zürich, Skin Cancer Center, University Hospital, Zürich, Switzerland.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Guminksi', 'Affiliation': 'Department of Medical Oncology, Royal North Shore Hospital, Sydney, Australia.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Gutzmer', 'Affiliation': 'Skin Cancer Center Hannover, Department of Dermatology, Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'J T', 'Initials': 'JT', 'LastName': 'Lear', 'Affiliation': 'Manchester Academic Health Science Centre, Manchester University and Salford Royal NHS Trust, Manchester, U.K.'}, {'ForeName': 'K D', 'Initials': 'KD', 'LastName': 'Lewis', 'Affiliation': 'University of Colorado Cancer Center, Anschutz, Aurora, CO, U.S.A.'}, {'ForeName': 'A L S', 'Initials': 'ALS', 'LastName': 'Chang', 'Affiliation': 'Department of Dermatology, Stanford University School of Medicine, Redwood City, CA, U.S.A.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Combemale', 'Affiliation': 'Department of Dermatology, Hôpitaux Universitaires de Lyon, Université de Lyon, Lyon, France.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Dirix', 'Affiliation': 'Saint-Augustinus Hospital, Antwerp, Belgium.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Kaatz', 'Affiliation': 'Department of Dermatology, SRH Waldklinikum, Gera, Germany.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Kudchadkar', 'Affiliation': 'Emory University, Atlanta, GA, U.S.A.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Loquai', 'Affiliation': 'Department of Dermatology, University Medical Center Mainz, Mainz, Germany.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Plummer', 'Affiliation': 'Northern Centre for Cancer Care, The Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, U.K.'}, {'ForeName': 'H-J', 'Initials': 'HJ', 'LastName': 'Schulze', 'Affiliation': 'Department of Dermatology, Fachklinik Hornheide, Münster, Germany.'}, {'ForeName': 'A J', 'Initials': 'AJ', 'LastName': 'Stratigos', 'Affiliation': 'First Department of Dermatology-Venereology, National and Kapodistrian University of Athens School of Medicine, Andreas Sygros Hospital for Skin and Venereal Diseases, Athens, Greece.'}, {'ForeName': 'U', 'Initials': 'U', 'LastName': 'Trefzer', 'Affiliation': 'Department of Dermatology, University Hospital Charite, Berlin, Germany.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Squittieri', 'Affiliation': 'Sun Pharmaceutical Industries, Inc., Princeton, NJ, U.S.A.'}, {'ForeName': 'M R', 'Initials': 'MR', 'LastName': 'Migden', 'Affiliation': 'Departments of Dermatology and Head and Neck Surgery, The University of Texas-MD Anderson Cancer Center, Houston, TX, U.S.A.'}]",The British journal of dermatology,['10.1111/bjd.18552'] 861,31699709,"Combined Vaccination with NY-ESO-1 Protein, Poly-ICLC, and Montanide Improves Humoral and Cellular Immune Responses in Patients with High-Risk Melanoma.","Given its ability to induce both humoral and cellular immune responses, NY-ESO-1 has been considered a suitable antigen for a cancer vaccine. Despite promising results from early-phase clinical studies in patients with melanoma, NY-ESO-1 vaccine immunotherapy has not been widely investigated in larger trials; consequently, many questions remain as to the optimal vaccine formulation, predictive biomarkers, and sequencing and timing of vaccines in melanoma treatment. We conducted an adjuvant phase I/II clinical trial in high-risk resected melanoma to optimize the delivery of poly-ICLC, a TLR-3/MDA-5 agonist, as a component of vaccine formulation. A phase I dose-escalation part was undertaken to identify the MTD of poly-ICLC administered in combination with NY-ESO-1 and montanide. This was followed by a randomized phase II part investigating the MTD of poly-ICLC with NY-ESO-1 with or without montanide. The vaccine regimens were generally well tolerated, with no treatment-related grade 3/4 adverse events. Both regimens induced integrated NY-ESO-1-specific CD4 + T-cell and humoral responses. CD8 + T-cell responses were mainly detected in patients receiving montanide. T-cell avidity toward NY-ESO-1 peptides was higher in patients vaccinated with montanide. In conclusion, NY-ESO-1 protein in combination with poly-ICLC is safe, well tolerated, and capable of inducing integrated antibody and CD4 + T-cell responses in most patients. Combination with montanide enhances antigen-specific T-cell avidity and CD8 + T-cell cross-priming in a fraction of patients, indicating that montanide contributes to the induction of specific CD8 + T-cell responses to NY-ESO-1.",2020,T-cell avidity towards NY-ESO-1 peptides was higher in patients vaccinated with montanide.,['high-risk melanoma patients'],"['poly-ICLC with NY-ESO-1 with or without montanide', 'Combined vaccination with NY-ESO-1 protein, poly-ICLC']","['T-cell avidity towards NY-ESO-1 peptides', 'humoral and cellular immune responses', 'CD8+ T-cell responses']","[{'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0025202', 'cui_str': 'Malignant Melanoma'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0071359', 'cui_str': 'polyriboinosinic-polyribocytidylic acid-polylysine carboxymethylcellulose'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}]","[{'cui': 'C0039194', 'cui_str': 'Thymus-Dependent Lymphocytes'}, {'cui': 'C0030956', 'cui_str': 'Peptides'}, {'cui': 'C1817908', 'cui_str': 'Cellular Immune Response'}]",,0.0441376,T-cell avidity towards NY-ESO-1 peptides was higher in patients vaccinated with montanide.,"[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Pavlick', 'Affiliation': 'Cancer Institute, New York University School of Medicine, New York, New York.'}, {'ForeName': 'Ana B', 'Initials': 'AB', 'LastName': 'Blazquez', 'Affiliation': 'Tisch Cancer Institute, Departments of Medicine, Hematology and Medical Oncology, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Marcia', 'Initials': 'M', 'LastName': 'Meseck', 'Affiliation': 'Tisch Cancer Institute, Departments of Medicine, Hematology and Medical Oncology, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Lattanzi', 'Affiliation': 'Cancer Institute, New York University School of Medicine, New York, New York.'}, {'ForeName': 'Patrick A', 'Initials': 'PA', 'LastName': 'Ott', 'Affiliation': 'Dana-Farber Cancer Institute, Boston, Massachusetts.'}, {'ForeName': 'Thomas U', 'Initials': 'TU', 'LastName': 'Marron', 'Affiliation': 'Tisch Cancer Institute, Departments of Medicine, Hematology and Medical Oncology, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Rose Marie', 'Initials': 'RM', 'LastName': 'Holman', 'Affiliation': 'New York University School of Medicine, New York, New York.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Mandeli', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, Tisch Cancer Institute, New York, New York.'}, {'ForeName': 'Andres M', 'Initials': 'AM', 'LastName': 'Salazar', 'Affiliation': 'Oncovir, Inc., Washington, D.C.'}, {'ForeName': 'Christopher B', 'Initials': 'CB', 'LastName': 'McClain', 'Affiliation': 'Tisch Cancer Institute, Departments of Medicine, Hematology and Medical Oncology, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Gustavo', 'Initials': 'G', 'LastName': 'Gimenez', 'Affiliation': 'Tisch Cancer Institute, Departments of Medicine, Hematology and Medical Oncology, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Sreekumar', 'Initials': 'S', 'LastName': 'Balan', 'Affiliation': 'Tisch Cancer Institute, Departments of Medicine, Hematology and Medical Oncology, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Sacha', 'Initials': 'S', 'LastName': 'Gnjatic', 'Affiliation': 'Tisch Cancer Institute, Departments of Medicine, Hematology and Medical Oncology, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Rachel Lubong', 'Initials': 'RL', 'LastName': 'Sabado', 'Affiliation': 'Genentech, San Francisco, California.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Bhardwaj', 'Affiliation': 'Tisch Cancer Institute, Departments of Medicine, Hematology and Medical Oncology, Icahn School of Medicine at Mount Sinai, New York, New York. nina.bhardwaj@mssm.edu.'}]",Cancer immunology research,['10.1158/2326-6066.CIR-19-0545'] 862,30706087,"Randomised clinical trial assessing migration of uncemented primary total hip replacement stems, with and without autologous impaction bone grafting.","PURPOSE Uncemented stems in primary total hip replacement (THR) are concerning in the elderly due to ectatic femoral canals and cortical thinning resulting in higher incidence of fracture and subsidence in this population. To obviate this concern, the authors developed a technique using autologous impaction bone grafting to achieve a better fitting femoral stem. The aim of this randomised clinical trial was to assess the efficacy of the technique. METHODS From 2013 to 2015, a total of 98 consecutive participants (100 primary THR procedures) were inducted into a single-institution, single-blinded, randomised clinical trial assessing, with radiostereometric analysis (RSA), the efficacy of autologous impaction bone grafting in uncemented primary THR compared with traditional uncemented primary THR technique. The primary outcome measure was femoral component migration using RSA. Secondary outcomes were post-operative proximal femoral bone density (using DEXA), hip function and quality of life using Oxford Hip Score (OHS) and Short Form-12 Health Survey (SF-12), hip pain and patient satisfaction. RESULTS There was no difference in femoral component stability (p > 0.5) or calcar resorption between the Graft and No Graft Groups at two years. There was also no difference in OHS, SF-12, pain or satisfaction between the Graft and No Graft Groups at two years (p > 0.39). CONCLUSIONS Autologous impaction bone grafting in uncemented primary THR has shown its short-term post-operative outcomes to be equivalent to standard uncemented technique, whilst offering a better fit in patients who are between femoral stem sizes. AUSTRALIAN CLINICAL TRIAL REGISTRATION NUMBER ACTRN12618000652279.",2019,"There was also no difference in OHS, SF-12, pain or satisfaction between the Graft and No Graft Groups at two years (p > 0.39). ","['primary total hip replacement (THR', 'patients who are between femoral stem sizes', 'From 2013 to 2015, a total of 98 consecutive participants (100 primary THR procedures']","['Autologous impaction bone grafting', 'autologous impaction bone grafting in uncemented primary THR compared with traditional uncemented primary THR technique', 'uncemented primary total hip replacement stems, with and without autologous impaction bone grafting']","['calcar resorption', 'post-operative proximal femoral bone density (using DEXA), hip function and quality of life using Oxford Hip Score (OHS) and Short Form-12 Health Survey (SF-12), hip pain and patient satisfaction', 'femoral component migration using RSA', 'femoral component stability', 'OHS, SF-12, pain or satisfaction']","[{'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0040508', 'cui_str': 'Hip Replacement, Total'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0015811', 'cui_str': 'Femur'}, {'cui': 'C0162731', 'cui_str': 'STEM'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}]","[{'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C0333124', 'cui_str': 'Impaction (morphologic abnormality)'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C2363941', 'cui_str': 'Impaction bone graft'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0040508', 'cui_str': 'Hip Replacement, Total'}, {'cui': 'C0162731', 'cui_str': 'STEM'}]","[{'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0205107', 'cui_str': 'Proximal (qualifier value)'}, {'cui': 'C0015811', 'cui_str': 'Femur'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0034380'}, {'cui': 'C1998079', 'cui_str': 'Oxford hip score'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0019559', 'cui_str': 'Hip pain (finding)'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C0449434', 'cui_str': 'Femoral component (attribute)'}, {'cui': 'C1533574', 'cui_str': 'Migration, function (observable entity)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",98.0,0.263788,"There was also no difference in OHS, SF-12, pain or satisfaction between the Graft and No Graft Groups at two years (p > 0.39). ","[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Rutherford', 'Affiliation': 'Hollywood Private Hospital, Monash Avenue, Perth, WA, 6009, Australia. michael.rutherford1@my.nd.edu.au.'}, {'ForeName': 'Riaz J K', 'Initials': 'RJK', 'LastName': 'Khan', 'Affiliation': 'Hollywood Private Hospital, Monash Avenue, Perth, WA, 6009, Australia.'}, {'ForeName': 'Daniel P', 'Initials': 'DP', 'LastName': 'Fick', 'Affiliation': 'Hollywood Private Hospital, Monash Avenue, Perth, WA, 6009, Australia.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Haebich', 'Affiliation': 'The Joint Studio, Suite 1/85 Monash Avenue, Perth, WA, 6009, Australia.'}, {'ForeName': 'Oscar', 'Initials': 'O', 'LastName': 'Nivbrant', 'Affiliation': 'Department of Orthopaedics, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Kozak', 'Affiliation': 'Royal Perth Hospital, 197 Wellington St., Perth, WA, 6000, Australia.'}]",International orthopaedics,['10.1007/s00264-019-04290-5'] 863,31720835,REFLECT-a phase 3 trial comparing efficacy and safety of lenvatinib to sorafenib for the treatment of unresectable hepatocellular carcinoma: an analysis of Japanese subset.,"BACKGROUND A phase 3, multinational, randomized, non-inferiority trial (REFLECT) compared the efficacy and safety of lenvatinib (LEN) and sorafenib (SOR) in patients with unresectable hepatocellular carcinoma (uHCC). LEN had an effect on overall survival (OS) compared to SOR, statistically confirmed by non-inferiority [OS: median = 13.6 months vs. 12.3 months; hazard ratio (HR) 0.92, 95% confidence interval (CI) 0.79-1.06], and demonstrated statistically significant improvements in progression-free survival (PFS) and the objective response rate (ORR) in the overall population. The results of a subset analysis that evaluated the efficacy and safety of LEN and SOR in the Japanese population are reported. METHODS The intent-to-treat population enrolled in Japan was analyzed. RESULTS Of 954 patients in the overall population, 168 Japanese patients were assigned to the LEN arm (N = 81) or the SOR arm (N = 87). Median OS was 17.6 months for LEN vs. 17.8 months for SOR (HR 0.90; 95% CI 0.62-1.29). LEN showed statistically significant improvements over SOR in PFS (7.2 months vs. 4.6 months) and ORR (29.6% vs. 6.9%). The relative dose intensity of LEN and SOR in the Japanese population was lower than in the overall population. Frequently observed, related adverse events included palmar-plantar erythrodysaesthesia syndrome (PPES), hypertension, decreased appetite, and proteinuria in the LEN arm, and PPES, hypertension, diarrhea, and alopecia in the SOR arm. CONCLUSIONS The efficacy and safety of LEN in the Japanese population were similar to those in the overall population of REFLECT. With manageable adverse events, LEN is a new treatment option for Japanese patients with uHCC. TRIAL REGISTRATION ID ClinicalTrials.gov. No. NCT01761266.",2020,"LEN had an effect on overall survival (OS) compared to SOR, statistically confirmed by non-inferiority [OS: median = 13.6 months vs. 12.3 months; hazard ratio (HR)","['954 patients in the overall population', '168 Japanese patients', 'Japanese patients with uHCC', 'patients with unresectable hepatocellular carcinoma (uHCC', 'unresectable hepatocellular carcinoma']","['lenvatinib to sorafenib', 'lenvatinib (LEN) and sorafenib (SOR', 'LEN']","['ORR', 'efficacy and safety', 'Median OS', 'SOR in PFS', 'palmar-plantar erythrodysaesthesia syndrome (PPES), hypertension, decreased appetite, and proteinuria in the LEN arm, and PPES, hypertension, diarrhea, and alopecia', 'overall survival (OS', 'progression-free survival (PFS) and the objective response rate (ORR', 'efficacy and safety of LEN and SOR', 'hazard ratio (HR']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C4319556', 'cui_str': 'One hundred and sixty-eight'}, {'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C2239176', 'cui_str': 'Liver Cell Carcinoma, Adult'}]","[{'cui': 'C2986924', 'cui_str': 'lenvatinib'}, {'cui': 'C1516119', 'cui_str': 'sorafenib'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0549410', 'cui_str': 'Chemotherapy-Induced Palmoplantar Erythrodysesthesia'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0232462', 'cui_str': 'Decrease in appetite (finding)'}, {'cui': 'C0033687', 'cui_str': 'Proteinuria'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0070932', 'cui_str': 'PPED'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0002170', 'cui_str': 'Hair Loss'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",168.0,0.10591,"LEN had an effect on overall survival (OS) compared to SOR, statistically confirmed by non-inferiority [OS: median = 13.6 months vs. 12.3 months; hazard ratio (HR)","[{'ForeName': 'Tatsuya', 'Initials': 'T', 'LastName': 'Yamashita', 'Affiliation': 'Department of Gastroenterology, Kanazawa University, Kanazawa, Japan. ytatsuya@m-kanazawa.jp.'}, {'ForeName': 'Masatoshi', 'Initials': 'M', 'LastName': 'Kudo', 'Affiliation': 'Department of Gastroenterology and Hepatology, Kindai University Faculty of Medicine, Osaka, Japan.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Ikeda', 'Affiliation': 'Department of Hepatology, Toranomon Hospital, Tokyo, Japan.'}, {'ForeName': 'Namiki', 'Initials': 'N', 'LastName': 'Izumi', 'Affiliation': 'Department of Gastroenterology and Hepatology, Musashino Red Cross Hospital, Musashino, Japan.'}, {'ForeName': 'Ryosuke', 'Initials': 'R', 'LastName': 'Tateishi', 'Affiliation': 'Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Masafumi', 'Initials': 'M', 'LastName': 'Ikeda', 'Affiliation': 'Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital East, Kashiwa, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Aikata', 'Affiliation': 'Department of Gastroenterology and Metabolism, Hiroshima University, Hiroshima, Japan.'}, {'ForeName': 'Yasunori', 'Initials': 'Y', 'LastName': 'Kawaguchi', 'Affiliation': 'Department of Hepatobiliary and Pancreatology, Saga-Ken Medical Center Koseikan, Saga, Japan.'}, {'ForeName': 'Yoshiyuki', 'Initials': 'Y', 'LastName': 'Wada', 'Affiliation': 'Department of Hepato-Biliary-Pancreatic Surgery, Clinical Research Institute, National Hospital Organization Kyushu Medical Center, Fukuoka, Japan.'}, {'ForeName': 'Kazushi', 'Initials': 'K', 'LastName': 'Numata', 'Affiliation': 'Gastroenterological Center, Yokohama City University Medical Center, Yokohama, Japan.'}, {'ForeName': 'Yoshitaka', 'Initials': 'Y', 'LastName': 'Inaba', 'Affiliation': 'Department of Diagnostic and Interventional Radiology, Aichi Cancer Center Hospital, Nagoya, Japan.'}, {'ForeName': 'Ryoko', 'Initials': 'R', 'LastName': 'Kuromatsu', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, Kurume University School of Medicine, Kurume, Japan.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Kobayashi', 'Affiliation': 'Department of Hepatology, Toranomon Hospital, Tokyo, Japan.'}, {'ForeName': 'Takuji', 'Initials': 'T', 'LastName': 'Okusaka', 'Affiliation': 'Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Toshiyuki', 'Initials': 'T', 'LastName': 'Tamai', 'Affiliation': 'Eisai Co., Ltd., Tokyo, Japan.'}, {'ForeName': 'Chifumi', 'Initials': 'C', 'LastName': 'Kitamura', 'Affiliation': 'Eisai Co., Ltd., Tokyo, Japan.'}, {'ForeName': 'Kenichi', 'Initials': 'K', 'LastName': 'Saito', 'Affiliation': 'Eisai Co., Ltd., Tokyo, Japan.'}, {'ForeName': 'Katsuya', 'Initials': 'K', 'LastName': 'Haruna', 'Affiliation': 'Eisai Co., Ltd., Tokyo, Japan.'}, {'ForeName': 'Kiwamu', 'Initials': 'K', 'LastName': 'Okita', 'Affiliation': 'Department of Hepatology, Shunan Memorial Hospital, Kudamatsu, Japan.'}, {'ForeName': 'Hiromitsu', 'Initials': 'H', 'LastName': 'Kumada', 'Affiliation': 'Department of Hepatology, Toranomon Hospital, Tokyo, Japan.'}]",Journal of gastroenterology,['10.1007/s00535-019-01642-1'] 864,31814306,Delta-shaped anastomosis vs circular stapler anastomosis after laparoscopic distal gastrectomy with Billroth I reconstruction: A randomized controlled trial.,"INTRODUCTION The aim of this study is to evaluate the efficacy of delta-shaped anastomosis compared to circular stapler anastomosis in laparoscopic distal gastrectomy with Billroth I reconstruction. METHODS This is a single-center randomized controlled study. Eligibility criteria included histologically proven gastric adenocarcinoma in the lower third of the stomach, clinical stage I tumor. Patients were preoperatively randomized to circular stapler anastomosis or delta-shaped anastomosis. The primary endpoint is the number of analgesics used during three days after surgery. We compared the surgical outcomes of the two groups. Postoperative quality of life was evaluated using the Postgastrectomy Syndrome Assessment Scale-45. This trial was registered at the UMIN Clinical Trials Registry as UMIN000025160. RESULTS Between December 2016 and September 2018, 39 patients (delta-shaped anastomosis 18, circular stapler anastomosis 21) were enrolled. There was no difference in the number of analgesics used during three days after surgery (median nine: delta-shaped anastomosis vs nine: circular stapler anastomosis, P = .91). There was no difference in the overall proportion with in-hospital grade II-IIIB surgical complications (11%: delta-shaped anastomosis, 14%: circular stapler anastomosis). There was no operation-related death in either arm. Regarding postoperative quality of life evaluated one month after surgery, diarrhea subscale was significantly worse in delta-shaped anastomosis than in circular stapler anastomosis. CONCLUSION We did not demonstrate the advantage of delta-shaped anastomosis in terms of postoperative pain. Since delta-shaped anastomosis tended to cause postoperative abdominal symptoms related to diarrhea, we should carefully apply the delta-shaped anastomosis to laparoscopic distal gastrectomy with Billroth I reconstruction.",2020,"There was no difference in the number of analgesics used during three days after surgery (median nine: delta-shaped anastomosis vs nine: circular stapler anastomosis, P = .91).","['39 patients (delta-shaped anastomosis 18, circular stapler anastomosis 21) were enrolled', 'Between December 2016 and September 2018', 'Eligibility criteria included histologically proven gastric adenocarcinoma in the lower third of the stomach, clinical stage I tumor']","['circular stapler anastomosis or delta-shaped anastomosis', 'Delta-shaped anastomosis vs circular stapler anastomosis after laparoscopic distal gastrectomy with Billroth I', 'circular stapler anastomosis', 'laparoscopic distal gastrectomy with Billroth I reconstruction', 'delta-shaped anastomosis']","['overall proportion with in-hospital grade II-IIIB surgical complications', 'number of analgesics', 'diarrhea subscale', 'Postoperative quality of life', 'operation-related death']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439097', 'cui_str': 'Delta'}, {'cui': 'C0522512', 'cui_str': 'With shape (attribute)'}, {'cui': 'C0332853', 'cui_str': 'Anastomosis (morphologic abnormality)'}, {'cui': 'C1282913', 'cui_str': 'Circular (qualifier value)'}, {'cui': 'C0441062', 'cui_str': 'Stapler (physical object)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0456369', 'cui_str': 'Proven (qualifier value)'}, {'cui': 'C1704242', 'cui_str': 'Gastric (qualifier value)'}, {'cui': 'C0001418', 'cui_str': 'Adenoma, Malignant'}, {'cui': 'C0442051', 'cui_str': 'Lower third (qualifier value)'}, {'cui': 'C3714551', 'cui_str': 'Stomach structure (body structure)'}, {'cui': 'C0205564', 'cui_str': 'Clinical stage I (finding)'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}]","[{'cui': 'C1282913', 'cui_str': 'Circular (qualifier value)'}, {'cui': 'C0441062', 'cui_str': 'Stapler (physical object)'}, {'cui': 'C0332853', 'cui_str': 'Anastomosis (morphologic abnormality)'}, {'cui': 'C0439097', 'cui_str': 'Delta'}, {'cui': 'C0522512', 'cui_str': 'With shape (attribute)'}, {'cui': 'C0205108', 'cui_str': 'Distal (qualifier value)'}, {'cui': 'C0017118', 'cui_str': 'Gastrectomy'}, {'cui': 'C0192440', 'cui_str': 'Billroth I Operation'}, {'cui': 'C0524865', 'cui_str': 'Reconstructive Surgery'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0034380'}, {'cui': 'C0038895', 'cui_str': 'operative therapy'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",39.0,0.0497371,"There was no difference in the number of analgesics used during three days after surgery (median nine: delta-shaped anastomosis vs nine: circular stapler anastomosis, P = .91).","[{'ForeName': 'Kei', 'Initials': 'K', 'LastName': 'Hosoda', 'Affiliation': 'Department of Surgery, Kitasato University School of Medicine, Sagamihara, Japan.'}, {'ForeName': 'Hiroaki', 'Initials': 'H', 'LastName': 'Mieno', 'Affiliation': 'Department of Surgery, Kitasato University School of Medicine, Sagamihara, Japan.'}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Ema', 'Affiliation': 'Department of Surgery, Kitasato University School of Medicine, Sagamihara, Japan.'}, {'ForeName': 'Hideki', 'Initials': 'H', 'LastName': 'Ushiku', 'Affiliation': 'Department of Surgery, Kitasato University School of Medicine, Sagamihara, Japan.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Washio', 'Affiliation': 'Department of Surgery, Kitasato University School of Medicine, Sagamihara, Japan.'}, {'ForeName': 'Ildae', 'Initials': 'I', 'LastName': 'Song', 'Affiliation': 'Kitasato Clinical Research Center, Kitasato University School of Medicine, Sagamihara, Japan.'}, {'ForeName': 'Masahiko', 'Initials': 'M', 'LastName': 'Watanabe', 'Affiliation': 'Department of Surgery, Kitasato University School of Medicine, Sagamihara, Japan.'}, {'ForeName': 'Keishi', 'Initials': 'K', 'LastName': 'Yamashita', 'Affiliation': 'Department of Surgery, Kitasato University School of Medicine, Sagamihara, Japan.'}, {'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Hiki', 'Affiliation': 'Department of Surgery, Kitasato University School of Medicine, Sagamihara, Japan.'}]",Asian journal of endoscopic surgery,['10.1111/ases.12770'] 865,31302012,Markers of adipose tissue inflammation are transiently elevated during intermittent fasting in women who are overweight or obese.,"OBJECTIVE This study compared the effects of daily calorie restriction (DR) versus intermittent fasting (IF) on markers of inflammation and extracellular matrix deposition in adipose tissue and skeletal muscle in a controlled feeding trial in women with overweight or obesity. METHODS Women (N = 76) were randomised to one of three diets and provided with all foods at 100% (IF100) or 70% (IF70 and DR70) of calculated energy requirements for 8 weeks. IF groups ate breakfast prior to fasting for 24-h on 3 non-consecutive days/week. Weight, body composition, serum non-esterified fatty acids (NEFA), tumour necrosis factor-alpha (TNFα), interleukin-6 (IL-6), interleukin-10 (IL-10), M1- and M2-macrophage markers by qPCR and immunohistochemistry in adipose tissue and skeletal muscle were measured following a 12-h overnight fast (fed day, all groups) and a 24-h fast (IF groups only). RESULTS IF70 resulted in greater weight and fat losses and reductions in serum NEFA versus DR70 and IF100 (P < 0.05) after fed days. Markers of inflammation in serum (TNFα, IL6 and IL10), subcutaneous adipose tissue and skeletal muscle (CD68, CD40 and CD163) were unchanged by DR or IF after fed days. After fasting, NEFA, M1-macrophages (CD40 + ) in adipose tissue, and M2-macrophages (CD163 + ) in muscle were increased in IF70 and IF100 (all P < 0.05) and the changes in NEFA and mRNA of pan-macrophage marker CD68 in adipose tissue were positively correlated (r = 0.56, P = 0.002). CONCLUSIONS Unlike caloric restriction, IF transiently elevated markers of macrophage infiltration in adipose tissue and skeletal muscle, possibly in response to marked increases in adipose tissue lipolysis.",2019,"RESULTS IF70 resulted in greater weight and fat losses and reductions in serum NEFA versus DR70 and IF100","['women who are overweight or obese', 'Women (N\u202f=\u202f76', 'women with overweight or obesity']",['daily calorie restriction (DR) versus intermittent fasting (IF'],"['adipose tissue inflammation', 'fasting, NEFA, M1-macrophages (CD40 + ) in adipose tissue, and M2-macrophages (CD163 + ) in muscle', 'Markers of inflammation in serum (TNFα, IL6 and IL10), subcutaneous adipose tissue and skeletal muscle (CD68, CD40 and CD163', 'adipose tissue lipolysis', 'weight and fat losses and reductions in serum NEFA versus DR70 and IF100', 'Weight, body composition, serum non-esterified fatty acids (NEFA), tumour necrosis factor-alpha (TNFα), interleukin-6 (IL-6), interleukin-10 (IL-10), M1- and M2-macrophage markers by qPCR and immunohistochemistry in adipose tissue and skeletal muscle', 'changes in NEFA and mRNA of pan-macrophage marker CD68 in adipose tissue']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C1879985', 'cui_str': 'calorie'}, {'cui': 'C0205267', 'cui_str': 'Intermittent (qualifier value)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}]","[{'cui': 'C0001527', 'cui_str': 'Fatty Tissue'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0015688', 'cui_str': 'NEFA'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0222331', 'cui_str': 'Subcutaneous Fat'}, {'cui': 'C0242692', 'cui_str': 'Muscle, Voluntary'}, {'cui': 'C0023796', 'cui_str': 'Lipolysis'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0369212', 'cui_str': 'Fatty Acids, Esterified'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0024432', 'cui_str': 'Monocyte-Derived Macrophages'}, {'cui': 'C0021044', 'cui_str': 'Immunohistochemistry'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0035696', 'cui_str': 'mRNA'}, {'cui': 'C0085999', 'cui_str': 'Genus Pan (organism)'}]",,0.0455408,"RESULTS IF70 resulted in greater weight and fat losses and reductions in serum NEFA versus DR70 and IF100","[{'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Liu', 'Affiliation': 'Adelaide Medical School, University of Adelaide, Adelaide, South Australia 5000, Australia; Lifelong Health Theme, South Australian Health and Medical Research Institute, Adelaide, South Australia 5000, Australia.'}, {'ForeName': 'Amy T', 'Initials': 'AT', 'LastName': 'Hutchison', 'Affiliation': 'Adelaide Medical School, University of Adelaide, Adelaide, South Australia 5000, Australia; Lifelong Health Theme, South Australian Health and Medical Research Institute, Adelaide, South Australia 5000, Australia.'}, {'ForeName': 'Campbell H', 'Initials': 'CH', 'LastName': 'Thompson', 'Affiliation': 'Adelaide Medical School, University of Adelaide, Adelaide, South Australia 5000, Australia.'}, {'ForeName': 'Kylie', 'Initials': 'K', 'LastName': 'Lange', 'Affiliation': 'Adelaide Medical School, University of Adelaide, Adelaide, South Australia 5000, Australia.'}, {'ForeName': 'Leonie K', 'Initials': 'LK', 'LastName': 'Heilbronn', 'Affiliation': 'Adelaide Medical School, University of Adelaide, Adelaide, South Australia 5000, Australia; Lifelong Health Theme, South Australian Health and Medical Research Institute, Adelaide, South Australia 5000, Australia. Electronic address: leonie.heilbronn@adelaide.edu.au.'}]",Obesity research & clinical practice,['10.1016/j.orcp.2019.07.001'] 866,31888682,Below-elbow or above-elbow cast for conservative treatment of extra-articular distal radius fractures with dorsal displacement: a prospective randomized trial.,"BACKGROUND Distal radial fractures are common traumatic injuries, but their management remains controversial also in case of conservative treatment regarding the type of immobilisation. Hence, we conducted a two-arm, parallel-group, prospective randomised trial to compare the capacity of long casts (above-elbow) and short casts (below-elbow) to maintain the reduction of extra-articular distal radius fractures with dorsal displacement (AO/OTA classification: 2R3A2.2). METHODS Seventy-four eligible patients with AO/OTA 2R3A2.2 fractures treated with closed reduction and cast immobilisation were randomised to the long cast group (n°= 37) or to the short cast group (n°= 37). Baseline radiological parameters, radial inclination (RI), radial height (RH), ulnar variance (UV) and palmar tilt (PT) were taken, and compared with clinical (DASH, Mayo Wrist and Mayo Elbow) and radiological scores taken at 7-10 days, 4 weeks and 12 weeks. Furthermore, to evaluate correlations between radiological parameters and functional outcomes, patients were divided into two groups according to whether or not their radiological parameters at Follow-ups 2 and 3 were acceptable, i.e. within the range 11-12 mm for RH, 16°-28° for RI, - 4-+ 2 mm for UV and 0°-22° for PT. RESULTS Patient demographic and baseline radiological parameters were similar between groups. At follow-up, there were no statistically significant differences between the two types of cast in terms of RI, RH, UV or PT, or Mayo wrist or DASH scores. Short cast group patients displayed better Mayo elbow score at follow-up 2 (4 weeks), but this difference was no longer statistically significant at follow-up 3 (12 weeks). No statistically significant differences in clinical outcomes were found between patients who presented acceptable radiographic parameters at follow-up and those who did not. CONCLUSION As there were no significant differences between short casts and long casts in terms of fracture reduction maintenance or clinical outcomes, short casts are an effective method of post-reduction immobilisation in AO/OTA 2R3A2.2 fracture of the radius. Radiological parameters outside the range conventionally considered acceptable do not preclude a satisfactory clinical outcome. TRIAL REGISTRATION ClinicalTrials.gov PRS, NCT04062110. Registred 20 August 2019.",2019,"As there were no significant differences between short casts and long casts in terms of fracture reduction maintenance or clinical outcomes, short casts are an effective method of post-reduction immobilisation in AO/OTA 2R3A2.2 fracture of the radius.","['Seventy-four eligible patients with AO/OTA 2R3A2.2 fractures treated with closed reduction and cast immobilisation', 'extra-articular distal radius fractures with dorsal displacement']",['Below-elbow or above-elbow cast'],"['RI, RH, UV or PT, or Mayo wrist or DASH scores', 'Mayo elbow score', 'Baseline radiological parameters, radial inclination (RI), radial height (RH), ulnar variance (UV) and palmar tilt (PT) were taken, and compared with clinical (DASH, Mayo Wrist and Mayo Elbow) and radiological scores', 'clinical outcomes']","[{'cui': 'C4517867', 'cui_str': 'Seventy-four'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0302143', 'cui_str': 'Casts (qualifier value)'}, {'cui': 'C0020944', 'cui_str': 'Immobilization'}, {'cui': 'C0205135', 'cui_str': 'Extra-articular (qualifier value)'}, {'cui': 'C0588207', 'cui_str': 'Bone structure of distal radius (body structure)'}, {'cui': 'C0333044', 'cui_str': 'Posterior displacement (qualifier value)'}]","[{'cui': 'C0013769', 'cui_str': 'Elbow'}, {'cui': 'C0302143', 'cui_str': 'Casts (qualifier value)'}]","[{'cui': 'C0454788', 'cui_str': 'Mayo (geographic location)'}, {'cui': 'C0043262', 'cui_str': 'Wrist'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0013769', 'cui_str': 'Elbow'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0442038', 'cui_str': 'Radial (qualifier value)'}, {'cui': 'C0442044', 'cui_str': 'Ulnar (qualifier value)'}, {'cui': 'C1184147', 'cui_str': 'Palmar (qualifier value)'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}]",74.0,0.0494351,"As there were no significant differences between short casts and long casts in terms of fracture reduction maintenance or clinical outcomes, short casts are an effective method of post-reduction immobilisation in AO/OTA 2R3A2.2 fracture of the radius.","[{'ForeName': 'Gaetano', 'Initials': 'G', 'LastName': 'Caruso', 'Affiliation': ""Orthopedic and Traumatology Unit, Sant'Anna University Hospital of Ferrara, Via Aldo Moro 8, 44124 Cona, Ferrara, Italy. crsgtn@unife.it.""}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Tonon', 'Affiliation': ""Orthopedic and Traumatology Unit, Sant'Anna University Hospital of Ferrara, Via Aldo Moro 8, 44124 Cona, Ferrara, Italy.""}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Gildone', 'Affiliation': ""Orthopedic and Traumatology Unit, Sant'Anna University Hospital of Ferrara, Via Aldo Moro 8, 44124 Cona, Ferrara, Italy.""}, {'ForeName': 'Mattia', 'Initials': 'M', 'LastName': 'Andreotti', 'Affiliation': ""Orthopedic and Traumatology Unit, Sant'Anna University Hospital of Ferrara, Via Aldo Moro 8, 44124 Cona, Ferrara, Italy.""}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Altavilla', 'Affiliation': ""Orthopedic and Traumatology Unit, Sant'Anna University Hospital of Ferrara, Via Aldo Moro 8, 44124 Cona, Ferrara, Italy.""}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Valentini', 'Affiliation': 'Department of Statistics, University of Bologna, Via Zamboni 33, 40126, Bologna, Italy.'}, {'ForeName': 'Giorgia', 'Initials': 'G', 'LastName': 'Valpiani', 'Affiliation': ""Research Innovation Quality and Accreditation Unit, Sant'Anna University Hospital of Ferrara, Via Aldo Moro 8, 44124 Cona, Ferrara, Italy.""}, {'ForeName': 'Leo', 'Initials': 'L', 'LastName': 'Massari', 'Affiliation': ""Orthopedic and Traumatology Unit, Sant'Anna University Hospital of Ferrara, Via Aldo Moro 8, 44124 Cona, Ferrara, Italy.""}]",Journal of orthopaedic surgery and research,['10.1186/s13018-019-1530-1'] 867,31855785,Long-term effects of pulmonary rehabilitation on daily life physical activity of patients with stage IV sarcoidosis: A randomized controlled trial.,"INTRODUCTION Pulmonary rehabilitation (PR) is known to improve exercise tolerance, mood, and quality of life in patients with chronic respiratory diseases. The aim of this work was to determine whether PR provides long-term benefits in increasing daily life physical activity in patients with chronic sarcoidosis. METHODS This randomized prospective study (registered ClinicalTrials.gov NCT02044939) of 38 patients with stage IV chronic sarcoidosis was performed between 2012 and 2016. Patients were assigned to participate in a 2-month PR program (n=20) or receive counseling (n=18). Assessments were performed at baseline, 2 months (end of the PR program), 6months, and 12months, and included daily life physical activity parameters (measured for 5 consecutive days), exercise tolerance, dyspnea, anxiety, depression, fatigue, and quality of life. The primary outcome was the 12-month change in time spent in activities above an estimated energy expenditure of 2.5metabolic equivalents (METs). Secondary daily life physical activity outcomes included number of steps per day, total daily energy expenditure, and total energy expenditure above 2.5METs. RESULTS The primary outcome did not differ between the two groups; mean between-group differences were -13.2min (95% confidence interval [CI]: -76.3 to 49.8) at 6 months and -18.1min (95% CI: -55.7 to 19.4) at 12months. Although PR had no effect on secondary daily life physical activity outcomes, it did significantly increase exercise tolerance at 6 and 12 months and decrease the dyspnea score at 6 months and the fatigue score at 12months. CONCLUSION This trial failed to demonstrate a beneficial effect of PR on daily life physical activity in sarcoidosis patients, suggesting that long-term behavioral programs may be necessary to complement PR.",2020,The primary outcome did not differ between the two groups; mean between-group differences were -13.2min,"['sarcoidosis patients', 'patients with stage IV sarcoidosis', '38 patients with stage IV chronic sarcoidosis was performed between 2012 and 2016', 'patients with chronic respiratory diseases', 'patients with chronic sarcoidosis']","['Pulmonary rehabilitation (PR', 'PR', 'pulmonary rehabilitation', 'PR program']","['secondary daily life physical activity outcomes', 'exercise tolerance', 'daily life physical activity parameters', 'number of steps per day, total daily energy expenditure, and total energy expenditure above 2.5METs', 'dyspnea score', 'exercise tolerance, dyspnea, anxiety, depression, fatigue, and quality of life', 'fatigue score', '12-month change in time spent in activities above an estimated energy expenditure of 2.5metabolic equivalents (METs', 'exercise tolerance, mood, and quality of life', 'daily life physical activity']","[{'cui': 'C0036202', 'cui_str': ""Boeck's Sarcoid""}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441772', 'cui_str': 'Stage level 4 (qualifier value)'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0264220', 'cui_str': 'Chronic disease of respiratory system'}]","[{'cui': 'C0199529', 'cui_str': 'Pulmonary rehabilitation (regime/therapy)'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0162521', 'cui_str': 'Exercise Tolerance'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0439505', 'cui_str': 'per day'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0014272', 'cui_str': 'Energy Expenditure'}, {'cui': 'C0429629', 'cui_str': 'Total energy expenditure (observable entity)'}, {'cui': 'C0013404', 'cui_str': 'Breathlessness'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0034380'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0026516', 'cui_str': 'Mood'}]",,0.178156,The primary outcome did not differ between the two groups; mean between-group differences were -13.2min,"[{'ForeName': 'B', 'Initials': 'B', 'LastName': 'Wallaert', 'Affiliation': 'CHU Lille, Service de Pneumologie et ImmunoAllergologie, Centre de Référence constitutif des Maladies Rares, Hôpital Calmette, 59037 Lille, France; University of Lille, 59000 Lille, France. Electronic address: bwallaert@gmail.com.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Kyheng', 'Affiliation': 'University of Lille, CHU Lille, EA 2694-Santé publique: épidémiologie et qualité des soins, Department of Biostatistics, 59000 Lille, France.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Labreuche', 'Affiliation': 'University of Lille, CHU Lille, EA 2694-Santé publique: épidémiologie et qualité des soins, Department of Biostatistics, 59000 Lille, France.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Stelianides', 'Affiliation': 'Division of Pneumology, Bichat Hospital, Paris-Diderot University, 75877, Paris, France.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Wemeau', 'Affiliation': 'CHU Lille, Service de Pneumologie et ImmunoAllergologie, Centre de Référence constitutif des Maladies Rares, Hôpital Calmette, 59037 Lille, France.'}, {'ForeName': 'J M', 'Initials': 'JM', 'LastName': 'Grosbois', 'Affiliation': 'FormactionSanté, 59840 Pérenchies, France.'}]",Respiratory medicine and research,['10.1016/j.resmer.2019.10.003'] 868,31917907,A Clinical Trial of a Psychoeducation Group Intervention for Patients With Borderline Personality Disorder.,"OBJECTIVE The objective of this study was to assess the impact of a 6-session psychoeducational group (PEG) intervention for borderline personality disorder (BPD) in an underserved community-based outpatient setting. METHODS The study was conducted between July 2015 and January 2017. Of 96 outpatients who met DSM-IV criteria for BPD, the first 48 received the experimental treatment, whereas the next 48 were assigned to a wait list. All received non-intensive treatment as usual. The primary outcome measure, the Zanarini Rating Scale for DSM-IV Borderline Personality Disorder (ZAN-BPD), was administered at baseline, at the end of treatment, and 2 months after the end of treatment. RESULTS The PEG intervention was associated with a significant improvement on all sectors of BPD (P < .001). Improvements were greater for the PEG on all sectors except impulsivity. Benefits remained stable during 2-month follow-up. The PEG intervention had a large effect size (Cohen d = -1.16), whereas the wait list effect size was small (Cohen d = -0.18). The between-arms effect size was 0.80 after treatment and 0.90 at follow-up. With full response defined as a decrease of ≥ 50% from baseline in ZAN-BPD total score, 22 patients (46%) in the psychoeducation group and 3 (6%) in the wait list group were considered full responders. CONCLUSIONS This study shows that a PEG intervention can be an effective treatment for patients with BPD. The overall cost benefits of group interventions and the the applicability of a PEG intervention to underserved patients demonstrate its potential to address significant public health needs.",2019,The PEG intervention was associated with a significant improvement on all sectors of BPD (P < .001).,"['96 outpatients who met DSM-IV criteria for BPD, the first 48 received the experimental treatment, whereas the next 48 were assigned to a wait list', 'patients with BPD', 'borderline personality disorder (BPD) in an underserved community-based outpatient setting', 'Patients With Borderline Personality Disorder', 'July 2015 and January 2017']","['6-session psychoeducational group (PEG) intervention', 'Psychoeducation Group Intervention', 'PEG intervention']","['Zanarini Rating Scale for DSM-IV Borderline Personality Disorder (ZAN-BPD', 'wait list effect size', 'all sectors of BPD']","[{'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0220952', 'cui_str': 'DSM-IV'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0006012', 'cui_str': 'Borderline Personality Disorder'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0871175', 'cui_str': 'Psycho-education'}]","[{'cui': 'C0222045'}, {'cui': 'C0220952', 'cui_str': 'DSM-IV'}, {'cui': 'C0006012', 'cui_str': 'Borderline Personality Disorder'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}]",96.0,0.0347258,The PEG intervention was associated with a significant improvement on all sectors of BPD (P < .001).,"[{'ForeName': 'Maria Elena', 'Initials': 'ME', 'LastName': 'Ridolfi', 'Affiliation': ""Fano Outpatients' Services, DSM AV1, Via Guarnieri 16, 61032, Fano, Italy. mariaelena.ridolfi@gmail.com.""}, {'ForeName': 'Roberta', 'Initials': 'R', 'LastName': 'Rossi', 'Affiliation': 'Unit of Psychiatry, IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli, Brescia, Italy.'}, {'ForeName': 'Giorgia', 'Initials': 'G', 'LastName': 'Occhialini', 'Affiliation': ""Fano Outpatients' Services, DSM AV1, Fano, Italy.""}, {'ForeName': 'John G', 'Initials': 'JG', 'LastName': 'Gunderson', 'Affiliation': 'McLean Hospital, Belmont, Massachusetts, USA.'}]",The Journal of clinical psychiatry,['10.4088/JCP.19m12753'] 869,31823444,"Randomized, double-blind, 6-week non-inferiority study of lurasidone and risperidone for the treatment of schizophrenia.","AIM The aim of the present study was to evaluate the efficacy and safety of lurasidone for the treatment of Chinese schizophrenic patients. METHODS Hospitalized schizophrenia patients aged 18-65 were randomized to 6 weeks of double-blind, double-dummy, flexible-dose treatment with lurasidone (40 or 80 mg/day) or risperidone (2, 4 or 6 mg/day). Efficacy was evaluated using a non-inferiority comparison of lurasidone relative to risperidone based on week 6 change in the Positive and Negative Syndrome Scale (PANSS) total score. Safety assessments included adverse events, clinical laboratory measures, and electrocardiograms. RESULTS Four hundred and forty-four patients were screened to obtain an intent-to-treat sample of 384 patients, of whom 54 patients discontinued treatment prior to 6 weeks. Lurasidone met the criteria for non-inferiority versus risperidone on the PANSS total score. Adjusted mean (SE) change at week 6 on the PANSS total score was -31.2 (1.0) and -34.9 (1.0) in the lurasidone and risperidone group, respectively. The mean difference score was 3.7, and the upper boundary of the 95%-confidence interval (1.0-6.3) was less than the prespecified margin of 7.0. No clinically meaningful between-treatment group differences were evident on secondary efficacy measures, including PANSS positive, PANSS negative, Clinical Global Impression scale - Severity, and Calgary Depression Scale for Schizophrenia scales. The incidence of adverse events was lower for lurasidone vs risperidone for extrapyramidal symptoms (17.0% vs 38.2%), akathisia (7.2% vs 13.6%), prolactin increase (3.1% vs 14.1%), and weight increase (0.5% vs 5.2%). CONCLUSION Lurasidone was found to be non-inferior to risperidone on the primary endpoint with minimal effects on weight, metabolic parameters, or prolactin levels.",2020,"No clinically meaningful between-treatment group differences were evident on secondary efficacy measures, including PANSS positive, PANSS negative, Clinical Global Impression scale - Severity, and Calgary Depression Scale for Schizophrenia scales.","['Four hundred and forty-four patients were screened to obtain an intent-to-treat sample of 384 patients, of whom 54 patients discontinued treatment prior to 6\u2009weeks', 'Hospitalized schizophrenia patients aged 18-65', 'schizophrenia', 'Chinese schizophrenic patients']","['lurasidone and risperidone', 'lurasidone', 'risperidone']","['akathisia', 'efficacy and safety', 'weight increase', 'Efficacy', 'incidence of adverse events', 'adverse events, clinical laboratory measures, and electrocardiograms', 'weight, metabolic parameters, or prolactin levels', 'prolactin increase', 'extrapyramidal symptoms', 'secondary efficacy measures, including PANSS positive, PANSS negative, Clinical Global Impression scale - Severity, and Calgary Depression Scale for Schizophrenia scales', 'Positive and Negative Syndrome Scale (PANSS) total score']","[{'cui': 'C4517777', 'cui_str': '440 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C1301820', 'cui_str': 'Obtained (attribute)'}, {'cui': 'C1283828', 'cui_str': 'Intentional'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C1706472', 'cui_str': 'Discontinue - dosing instruction imperative'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}]","[{'cui': 'C2003424', 'cui_str': 'lurasidone'}, {'cui': 'C0073393', 'cui_str': 'Risperidone'}]","[{'cui': 'C0392156', 'cui_str': 'Akathisia'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0043094', 'cui_str': 'Weight Gain'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0033371', 'cui_str': 'Prolactin'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0553731', 'cui_str': 'PRL increased'}, {'cui': 'C0234133', 'cui_str': 'Extrapyramidal sign (finding)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C3639708', 'cui_str': 'Clinical global impression scale'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0222045'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C0451383', 'cui_str': 'Positive and negative syndrome scale (assessment scale)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",444.0,0.0943473,"No clinically meaningful between-treatment group differences were evident on secondary efficacy measures, including PANSS positive, PANSS negative, Clinical Global Impression scale - Severity, and Calgary Depression Scale for Schizophrenia scales.","[{'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Feng', 'Affiliation': 'Department of Psychiatry, Beijing Anding Hospital, National Clinical Research Center for Mental Disorders, Capital Medical University, Beijing, China.'}, {'ForeName': 'Jianguo', 'Initials': 'J', 'LastName': 'Shi', 'Affiliation': ""Department of Psychiatry, Xi'an Mental Health Center, Xi'an, China.""}, {'ForeName': 'Lili', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Department of Psychiatry, Tianjin Anding Hospital, Tianjin, China.'}, {'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Department of Psychiatry, Wuxi Mental Health Center, Wuxi, China.'}, {'ForeName': 'Yunlong', 'Initials': 'Y', 'LastName': 'Tan', 'Affiliation': 'Department of Psychiatry, Beijing Huilongguan Hospital, Beijing, China.'}, {'ForeName': 'Jingyuan', 'Initials': 'J', 'LastName': 'Zhao', 'Affiliation': 'Department of Psychiatry, Henan Provincial Mental Hospital, Xinxiang, China.'}, {'ForeName': 'Yuping', 'Initials': 'Y', 'LastName': 'Ning', 'Affiliation': 'Department of Psychiatry, Guangzhou Brain Hospital, Guangzhou, China.'}, {'ForeName': 'Shiping', 'Initials': 'S', 'LastName': 'Xie', 'Affiliation': 'Department of Psychiatry, Nanjing Brain Hospital, Nanjing, China.'}, {'ForeName': 'Xuejun', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Department of Psychiatry, Brain Hospital of Hunan Province, Changsha, China.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Liu', 'Affiliation': 'Department of Psychiatry, Sixth Hospital of Peking University, Beijing, China.'}, {'ForeName': 'Keqing', 'Initials': 'K', 'LastName': 'Li', 'Affiliation': 'Department of Psychiatry, Hebei Mental Health Center, Baoding, China.'}, {'ForeName': 'Xiaoliang', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Mental Health Institute, Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Lehua', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Department of Psychiatry, Second Xiangya Hospital of Central South University, Changsha, China.'}, {'ForeName': 'Xiufeng', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': 'Department of Psychiatry, First Affiliated Hospital of Kunming Medical University, Kunming, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Deng', 'Affiliation': 'Department of Psychiatry, West China Hospital of Sichuan University, Chengdu, China.'}, {'ForeName': 'Xiaoyan', 'Initials': 'X', 'LastName': 'Luo', 'Affiliation': 'Medical Division, Sumitomo Pharma(Suzhou)Co., Ltd, Beijing, China.'}, {'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Wang', 'Affiliation': 'Department of Psychiatry, Beijing Anding Hospital, National Clinical Research Center for Mental Disorders, Capital Medical University, Beijing, China.'}]",Psychiatry and clinical neurosciences,['10.1111/pcn.12965'] 870,31892758,The comparative efficacy of disinfectant wipes on common-use computer keyboards in a veterinary teaching hospital.,"The efficacies of 3 disinfectant wipes at reducing bacterial contamination on keyboards in a veterinary teaching hospital were studied. Thirty common-use keyboards were randomized into ""dirty"" and ""clean"" halves. Cultures were obtained from the ""dirty"" halves. The ""clean"" halves were disinfected with a randomly assigned wipe [peroxygen (AHP)-, alcohol-, quaternary ammonium (QAC)-based] or untreated (NT) and cultured. Colony-forming units (CFU) were enumerated after 48 hours. Mean reduction in CFU was 91.5%, 65.3%, 94.9%, and 78.8% for the AHP, alcohol, QAC, and NT groups, respectively. There was a significant reduction in CFUs between the dirty and clean keyboard halves within each group but no statistically significant differences were noted between groups. The reduction in CFUs in the NT group was attributed to the mechanical action of wiping the keyboard surface for culture. The use of disinfectant wipes reduced CFUs on keyboards and may be a useful component of veterinary infection control programs.",2020,There was a significant reduction in CFUs between the dirty and clean keyboard halves within each group but no statistically significant differences were noted between groups.,['Thirty common-use keyboards'],"['randomly assigned wipe [peroxygen (AHP)-, alcohol-, quaternary ammonium (QAC)-based] or untreated (NT) and cultured', 'disinfectant wipes']","['Mean reduction in CFU', 'CFUs', 'reduction in CFUs']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0205214', 'cui_str': 'Common (qualifier value)'}, {'cui': 'C1947944', 'cui_str': 'Use'}]","[{'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0002611', 'cui_str': 'Ammonium'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0012682', 'cui_str': 'Disinfectants'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}]",30.0,0.016321,There was a significant reduction in CFUs between the dirty and clean keyboard halves within each group but no statistically significant differences were noted between groups.,"[{'ForeName': 'Eileen K', 'Initials': 'EK', 'LastName': 'Wong', 'Affiliation': 'Departments of Small Animal Medicine and Surgery (Wong, Brainard, Greene, Koenig), Population Health (Burgess), and Large Animal Medicine (Hurley), College of Veterinary Medicine, University of Georgia, Athens, Georgia 30602, USA.'}, {'ForeName': 'Brandy A', 'Initials': 'BA', 'LastName': 'Burgess', 'Affiliation': 'Departments of Small Animal Medicine and Surgery (Wong, Brainard, Greene, Koenig), Population Health (Burgess), and Large Animal Medicine (Hurley), College of Veterinary Medicine, University of Georgia, Athens, Georgia 30602, USA.'}, {'ForeName': 'Ben M', 'Initials': 'BM', 'LastName': 'Brainard', 'Affiliation': 'Departments of Small Animal Medicine and Surgery (Wong, Brainard, Greene, Koenig), Population Health (Burgess), and Large Animal Medicine (Hurley), College of Veterinary Medicine, University of Georgia, Athens, Georgia 30602, USA.'}, {'ForeName': 'Craig E', 'Initials': 'CE', 'LastName': 'Greene', 'Affiliation': 'Departments of Small Animal Medicine and Surgery (Wong, Brainard, Greene, Koenig), Population Health (Burgess), and Large Animal Medicine (Hurley), College of Veterinary Medicine, University of Georgia, Athens, Georgia 30602, USA.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Hurley', 'Affiliation': 'Departments of Small Animal Medicine and Surgery (Wong, Brainard, Greene, Koenig), Population Health (Burgess), and Large Animal Medicine (Hurley), College of Veterinary Medicine, University of Georgia, Athens, Georgia 30602, USA.'}, {'ForeName': 'Amie', 'Initials': 'A', 'LastName': 'Koenig', 'Affiliation': 'Departments of Small Animal Medicine and Surgery (Wong, Brainard, Greene, Koenig), Population Health (Burgess), and Large Animal Medicine (Hurley), College of Veterinary Medicine, University of Georgia, Athens, Georgia 30602, USA.'}]",The Canadian veterinary journal = La revue veterinaire canadienne,[] 871,29886846,Avoidable waste of research related to outcome planning and reporting in clinical trials.,"BACKGROUND Inadequate planning, selective reporting, and incomplete reporting of outcomes in randomized controlled trials (RCTs) contribute to the problem of waste of research. We aimed to describe such a waste and to examine to what extent this waste could be avoided. METHODS This research-on-research study was based on RCTs included in Cochrane reviews with a summary of findings (SoF) table. We considered the outcomes reported in the SoF tables as surrogates for important outcomes for patients and other decision makers. We used a three-step approach. (1) First, in each review, we identified, for each important outcome, RCTs that were excluded from the corresponding meta-analysis. (2) Then, for these RCTs, we systematically searched for registrations and protocols to distinguish between inadequate planning (an important outcome was not reported in registries or protocols), selective reporting (an important outcome was reported in registries or protocols but not in publications), and incomplete reporting (an important outcome was incompletely reported in publications). (3) Finally, we assessed, with the consensus of five experts, the feasibility and cost of measuring the important outcomes that were not planned. We considered inadequately planned or selectively or incompletely reported important outcomes as avoidable waste if the outcome could have been easily measured at no additional cost based on expert evaluation. RESULTS Of the 2711 RCTs included in the main comparison of 290 reviews, 2115 (78%) were excluded from at least one meta-analysis of important outcomes. Every trial contributed to 55%, on average, of the meta-analyses of important outcomes. Of the 310 RCTs published in 2010 or later, 156 were registered. Inadequate planning affected 79% of these RCTs, whereas incomplete and selective reporting affected 41% and 15%, respectively. For 63% of RCTs, we found at least one missing important outcome for which the waste was avoidable and for 30%, the waste was avoidable for all important outcomes. CONCLUSIONS Most of the RCTs included in our sample did not contribute to all the important outcomes in meta-analyses, mostly because of inadequate planning or incomplete reporting. A large part of this waste of research seemed to be avoidable.",2018,"Inadequate planning affected 79% of these RCTs, whereas incomplete and selective reporting affected 41% and 15%, respectively.",[],[],[],[],[],[],,0.0429889,"Inadequate planning affected 79% of these RCTs, whereas incomplete and selective reporting affected 41% and 15%, respectively.","[{'ForeName': 'Youri', 'Initials': 'Y', 'LastName': 'Yordanov', 'Affiliation': 'INSERM, U1153, Hôpital Hôtel-Dieus, 1, place du parvis Notre Dame, 75004, Paris, France. youri.yordanov@aphp.fr.'}, {'ForeName': 'Agnes', 'Initials': 'A', 'LastName': 'Dechartres', 'Affiliation': 'INSERM, U1153, Hôpital Hôtel-Dieus, 1, place du parvis Notre Dame, 75004, Paris, France.'}, {'ForeName': 'Ignacio', 'Initials': 'I', 'LastName': 'Atal', 'Affiliation': 'INSERM, U1153, Hôpital Hôtel-Dieus, 1, place du parvis Notre Dame, 75004, Paris, France.'}, {'ForeName': 'Viet-Thi', 'Initials': 'VT', 'LastName': 'Tran', 'Affiliation': 'INSERM, U1153, Hôpital Hôtel-Dieus, 1, place du parvis Notre Dame, 75004, Paris, France.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Boutron', 'Affiliation': 'INSERM, U1153, Hôpital Hôtel-Dieus, 1, place du parvis Notre Dame, 75004, Paris, France.'}, {'ForeName': 'Perrine', 'Initials': 'P', 'LastName': 'Crequit', 'Affiliation': 'INSERM, U1153, Hôpital Hôtel-Dieus, 1, place du parvis Notre Dame, 75004, Paris, France.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Ravaud', 'Affiliation': 'INSERM, U1153, Hôpital Hôtel-Dieus, 1, place du parvis Notre Dame, 75004, Paris, France.'}]",BMC medicine,['10.1186/s12916-018-1083-x'] 872,31810418,Immunogenicity and safety of a multi-dose quadrivalent inactivated influenza vaccine in individuals aged 6 months to 17 years: a randomized phase III trial.,"Annual vaccination is the most effective way to prevent seasonal influenza. Influenza vaccines in multi-dose vial (MDV) formats can facilitate timely vaccination of large populations by reducing per-dose costs and cold storage requirements compared to single-dose pre-filled syringe (PFS) formats. MDV vaccines require thiomersal or another preservative to prevent microbial contamination. We conducted a randomized, open-label trial in 302 healthy subjects aged 6 months to 17 years to evaluate the immunogenicity and safety of a quadrivalent influenza vaccine (QIV) in a thiomersal-containing MDV format compared to the licensed thiomersal-free PFS format. Subjects were randomly assigned in a 1:1 ratio to receive the MDV (n = 153) or PFS (n = 149) format. Post-vaccination hemagglutination inhibition titers for all four vaccine strains were ≥4.9-fold higher than baseline titers with no difference in magnitude between the MDV and PFS groups. Seroconversion rates per strain were also comparable between the two groups. There were no differences in reactogenicity or safety between the two vaccine formats. These results showed that the MDV format of QIV was as safe and immunogenic as the PFS format in infants, children, and adolescents. These findings support the use of MDV QIV as a resource-saving alternative for seasonal influenza vaccination.",2020,Post-vaccination hemagglutination inhibition titers for all four vaccine strains were ≥4.9-fold higher than baseline titers with no difference in magnitude between the MDV and PFS groups.,"['302 healthy subjects aged 6\xa0months to 17\xa0years', 'individuals aged 6 months to 17 years']","['Influenza vaccines', 'multi-dose quadrivalent inactivated influenza vaccine', 'PFS', 'MDV', 'quadrivalent influenza vaccine (QIV) in a thiomersal-containing MDV format compared to the licensed thiomersal-free PFS format']","['Seroconversion rates per strain', 'reactogenicity or safety', 'immunogenicity and safety', 'Post-vaccination hemagglutination inhibition titers', 'Immunogenicity and safety']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C0021403', 'cui_str': 'Influenza Vaccines'}, {'cui': 'C3266262', 'cui_str': 'Multi'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C4318638', 'cui_str': 'Quadrivalent Influenza Vaccine'}, {'cui': 'C0039867', 'cui_str': 'thiomersal'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C1301627', 'cui_str': 'Format'}]","[{'cui': 'C4042908', 'cui_str': 'Seroconversion'}, {'cui': 'C0080194', 'cui_str': 'Strains'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0018904', 'cui_str': 'Hemagglutination Inhibition Tests'}, {'cui': 'C0475208', 'cui_str': 'TITR'}]",302.0,0.052979,Post-vaccination hemagglutination inhibition titers for all four vaccine strains were ≥4.9-fold higher than baseline titers with no difference in magnitude between the MDV and PFS groups.,"[{'ForeName': 'Joyce', 'Initials': 'J', 'LastName': 'Ojeda', 'Affiliation': 'Global Clinical Science, Sanofi Pasteur , Mexico City, Mexico.'}, {'ForeName': 'José Luis', 'Initials': 'JL', 'LastName': 'Arredondo', 'Affiliation': 'Instituto Nacional de Pediatría, Unidad de Investigación Clínica , Mexico City, Mexico.'}, {'ForeName': 'Perla', 'Initials': 'P', 'LastName': 'Salcedo', 'Affiliation': 'Hospital General de Ecatepec ""Las Américas"", Fraccionamiento las Américas , Ecatepec de Morelos, Mexico.'}, {'ForeName': 'Mercedes', 'Initials': 'M', 'LastName': 'Paredes-Paredes', 'Affiliation': 'JM Research Clinical Research Center , Cuernavaca, Mexico.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Dupuy', 'Affiliation': ""Global Biostatistical Sciences, Sanofi Pasteur , Marcy l'Étoile, France.""}, {'ForeName': 'Celine', 'Initials': 'C', 'LastName': 'Petit', 'Affiliation': ""Global Clinical Immunology, Sanofi Pasteur , Marcy l'Étoile, France.""}, {'ForeName': 'Anne Laure', 'Initials': 'AL', 'LastName': 'Chabanon', 'Affiliation': 'Global Pharmacovigilance, Sanofi Pasteur, Campus Sanofi Lyon , Lyon, France.'}, {'ForeName': 'Enrique', 'Initials': 'E', 'LastName': 'Rivas', 'Affiliation': 'Global Clinical Sciences, Sanofi Pasteur , Mexico City, Mexico.'}, {'ForeName': 'Sanjay', 'Initials': 'S', 'LastName': 'Gurunathan', 'Affiliation': 'Global Clinical Sciences, Sanofi Pasteur , Swiftwater, PA, USA.'}, {'ForeName': 'Iris', 'Initials': 'I', 'LastName': 'De Bruijn', 'Affiliation': ""Global Clinical Sciences, Sanofi Pasteur , Marcy l'Étoile, France.""}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Pepin', 'Affiliation': ""Global Clinical Sciences, Sanofi Pasteur , Marcy l'Étoile, France.""}]",Human vaccines & immunotherapeutics,['10.1080/21645515.2019.1697595'] 873,31113310,Tailored feedback reduced prolonged sitting time and improved the health of housewives: a single-blind randomized controlled pilot study.,"Reducing sitting time, independent of physical activity, is important for health. However, few reports have been published regarding physical activity of housewives compared to that of employed women. We examined strategies to shorten housewives' sitting time using a single-blind randomized controlled trial. Forty-eight housewives (38.0 ± 4.5 years old) were randomly assigned to one of three groups: pamphlet, self-feedback, and tailored feedback groups. All participants received a pamphlet describing the risks of prolonged sitting. The self-feedback and tailored feedback groups were also given feedback on sitting time by a smartphone application. The tailored feedback group received individual suggestions regarding lifestyle to shorten sitting time. We measured physical activity using an accelerometer and health-related quality of life using the Short-Form 8. The longest prolonged sitting time significantly decreased over time, a significant reduction was observed after the intervention only in the tailored feedback group. Vitality, mental health, and role emotional components of health-related quality of life showed a significant improvement with time but no significant differences were observed among the study groups. We suggested an easy approach to shortening prolonged sitting time in housewives using a pamphlet and feedback by smartphone. However, tailored consulting was necessary to yield a more effective result.",2020,"Vitality, mental health, and role emotional components of health-related quality of life showed a significant improvement with time but no significant differences were observed among the study groups.",['Forty-eight housewives (38.0 ± 4.5 years old'],"['pamphlet, self-feedback, and tailored feedback groups', 'individual suggestions regarding lifestyle to shorten sitting time']","['physical activity using an accelerometer and health-related quality of life', 'health of housewives', 'sitting time', 'Reducing sitting time', 'longest prolonged sitting time', 'Vitality, mental health, and role emotional components of health-related quality of life']","[{'cui': 'C4319608', 'cui_str': 'Forty-eight'}, {'cui': 'C3844009', 'cui_str': 'Four point five'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0038659', 'cui_str': 'Suggestion'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C1282927', 'cui_str': 'Shortened (qualifier value)'}, {'cui': 'C2584297', 'cui_str': 'Seated Position'}, {'cui': 'C1632851', 'cui_str': 'Times'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C2584297', 'cui_str': 'Seated Position'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}]",48.0,0.0167612,"Vitality, mental health, and role emotional components of health-related quality of life showed a significant improvement with time but no significant differences were observed among the study groups.","[{'ForeName': 'Tomomi', 'Initials': 'T', 'LastName': 'Kitagawa', 'Affiliation': 'Graduate School of Comprehensive Rehabilitation, Osaka Prefecture University, Habikino City, Osaka, Japan.'}, {'ForeName': 'Yumi', 'Initials': 'Y', 'LastName': 'Higuchi', 'Affiliation': 'Graduate School of Comprehensive Rehabilitation, Osaka Prefecture University, Habikino City, Osaka, Japan.'}, {'ForeName': 'Emiko', 'Initials': 'E', 'LastName': 'Todo', 'Affiliation': 'Graduate School of Comprehensive Rehabilitation, Osaka Prefecture University, Habikino City, Osaka, Japan.'}, {'ForeName': 'Tetsuya', 'Initials': 'T', 'LastName': 'Ueda', 'Affiliation': 'Graduate School of Comprehensive Rehabilitation, Osaka Prefecture University, Habikino City, Osaka, Japan.'}, {'ForeName': 'Suguru', 'Initials': 'S', 'LastName': 'Ando', 'Affiliation': 'Graduate School of Comprehensive Rehabilitation, Osaka Prefecture University, Habikino City, Osaka, Japan.'}, {'ForeName': 'Tatsunori', 'Initials': 'T', 'LastName': 'Murakami', 'Affiliation': 'Graduate School of Comprehensive Rehabilitation, Osaka Prefecture University, Habikino City, Osaka, Japan.'}]",Women & health,['10.1080/03630242.2019.1616043'] 874,31917372,"Early Signs Monitoring to Prevent Relapse in Psychosis and Promote Well-Being, Engagement, and Recovery: Protocol for a Feasibility Cluster Randomized Controlled Trial Harnessing Mobile Phone Technology Blended With Peer Support.","BACKGROUND Relapse in schizophrenia is a major cause of distress and disability and is predicted by changes in symptoms such as anxiety, depression, and suspiciousness (early warning signs [EWSs]). These can be used as the basis for timely interventions to prevent relapse. However, there is considerable uncertainty regarding the implementation of EWS interventions. OBJECTIVE This study was designed to establish the feasibility of conducting a definitive cluster randomized controlled trial comparing Early signs Monitoring to Prevent relapse in psychosis and prOmote Well-being, Engagement, and Recovery (EMPOWER) against treatment as usual (TAU). Our primary outcomes are establishing parameters of feasibility, acceptability, usability, safety, and outcome signals of a digital health intervention as an adjunct to usual care that is deliverable in the UK National Health Service and Australian community mental health service (CMHS) settings. We will assess the feasibility of candidate primary outcomes, candidate secondary outcomes, and candidate mechanisms for a definitive trial. METHODS We will randomize CMHSs to EMPOWER or TAU. We aim to recruit up to 120 service user participants from 8 CMHSs and follow them for 12 months. Eligible service users will (1) be aged 16 years and above, (2) be in contact with local CMHSs, (3) have either been admitted to a psychiatric inpatient service or received crisis intervention at least once in the previous 2 years for a relapse, and (4) have an International Classification of Diseases-10 diagnosis of a schizophrenia-related disorder. Service users will also be invited to nominate a carer to participate. We will identify the feasibility of the main trial in terms of recruitment and retention to the study and the acceptability, usability, safety, and outcome signals of the EMPOWER intervention. EMPOWER is a mobile phone app that enables the monitoring of well-being and possible EWSs of relapse on a daily basis. An algorithm calculates changes in well-being based on participants' own baseline to enable tailoring of well-being messaging and clinical triage of possible EWSs. Use of the app is blended with ongoing peer support. RESULTS Recruitment to the trial began September 2018, and follow-up of participants was completed in July 2019. Data collection is continuing. The database was locked in July 2019, followed by analysis and disclosing of group allocation. CONCLUSIONS The knowledge gained from the study will inform the design of a definitive trial including finalizing the delivery of our digital health intervention, sample size estimation, methods to ensure successful identification, consent, randomization, and follow-up of participants, and the primary and secondary outcomes. The trial will also inform the final health economic model to be applied in the main trial. TRIAL REGISTRATION International Standard Randomized Controlled Trial Number (ISRCTN): 99559262; http://isrctn.com/ISRCTN99559262. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID) DERR1-10.2196/15058.",2020,"Our primary outcomes are establishing parameters of feasibility, acceptability, usability, safety, and outcome signals of a digital health intervention as an adjunct to usual care that is deliverable in the UK National Health Service and Australian community mental health service (CMHS) settings.","['120 service user participants from 8 CMHSs and follow them for 12 months', 'Eligible service users will (1) be aged 16 years and above, (2) be in contact with local CMHSs, (3) have either been admitted to a psychiatric inpatient service or received']",['crisis intervention'],"['feasibility, acceptability, usability, safety, and outcome signals of a digital health intervention as an adjunct to usual care that is deliverable in the UK National Health Service and Australian community mental health service (CMHS) settings']","[{'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332158', 'cui_str': 'Contact with (contextual qualifier) (qualifier value)'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0748064', 'cui_str': 'Psychiatric inpatient'}]","[{'cui': 'C0010332', 'cui_str': 'Crisis Intervention'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0027462', 'cui_str': 'Health Services, National'}, {'cui': 'C0009475', 'cui_str': 'Community Mental Health Services'}]",,0.248826,"Our primary outcomes are establishing parameters of feasibility, acceptability, usability, safety, and outcome signals of a digital health intervention as an adjunct to usual care that is deliverable in the UK National Health Service and Australian community mental health service (CMHS) settings.","[{'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Gumley', 'Affiliation': 'Glasgow Institute of Health and Wellbeing, Glasgow Mental Health Research Facility, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Bradstreet', 'Affiliation': 'Glasgow Institute of Health and Wellbeing, Glasgow Mental Health Research Facility, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Ainsworth', 'Affiliation': 'Division of Informatics, Imaging, and Data Sciences, School of Health Sciences, University of Manchester, Manchester, United Kingdom.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Allan', 'Affiliation': 'Glasgow Institute of Health and Wellbeing, Glasgow Mental Health Research Facility, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Alvarez-Jimenez', 'Affiliation': 'Orygen, The National Centre of Excellence in Youth Mental Health, Melbourne, Australia.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Beattie', 'Affiliation': 'Glasgow Institute of Health and Wellbeing, Glasgow Mental Health Research Facility, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Imogen', 'Initials': 'I', 'LastName': 'Bell', 'Affiliation': 'Orygen, The National Centre of Excellence in Youth Mental Health, Melbourne, Australia.'}, {'ForeName': 'Max', 'Initials': 'M', 'LastName': 'Birchwood', 'Affiliation': 'Division of Mental Health and Wellbeing, University of Warwick, Warwick, United Kingdom.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Briggs', 'Affiliation': 'London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Bucci', 'Affiliation': 'Division of Psychology and Mental Health, School of Health Sciences, University of Manchester, Manchester, United Kingdom.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Castagnini', 'Affiliation': 'La Trobe University, Melbourne, Australia.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Clark', 'Affiliation': 'Glasgow Institute of Health and Wellbeing, Glasgow Mental Health Research Facility, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Sue M', 'Initials': 'SM', 'LastName': 'Cotton', 'Affiliation': 'Orygen, The National Centre of Excellence in Youth Mental Health, Melbourne, Australia.'}, {'ForeName': 'Lidia', 'Initials': 'L', 'LastName': 'Engel', 'Affiliation': 'Deakin University, Melbourne, Australia.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'French', 'Affiliation': 'Manchester Metropolitan University, Manchester, United Kingdom.'}, {'ForeName': 'Reeva', 'Initials': 'R', 'LastName': 'Lederman', 'Affiliation': 'School of Computing and Information Systems, Melbourne School of Engineering, University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Shon', 'Initials': 'S', 'LastName': 'Lewis', 'Affiliation': 'Division of Psychology and Mental Health, School of Health Sciences, University of Manchester, Manchester, United Kingdom.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Machin', 'Affiliation': 'Division of Informatics, Imaging, and Data Sciences, School of Health Sciences, University of Manchester, Manchester, United Kingdom.'}, {'ForeName': 'Graeme', 'Initials': 'G', 'LastName': 'MacLennan', 'Affiliation': 'The Centre for Healthcare Randomised Trials, University of Aberdeen, Aberdeen, United Kingdom.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Matrunola', 'Affiliation': 'Glasgow Institute of Health and Wellbeing, Glasgow Mental Health Research Facility, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Hamish', 'Initials': 'H', 'LastName': 'McLeod', 'Affiliation': 'Glasgow Institute of Health and Wellbeing, Glasgow Mental Health Research Facility, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'McMeekin', 'Affiliation': 'Glasgow Institute of Health and Wellbeing, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Cathrine', 'Initials': 'C', 'LastName': 'Mihalopoulos', 'Affiliation': 'Deakin University, Melbourne, Australia.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Morton', 'Affiliation': 'Australian Catholic University, Melbourne, Australia.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Norrie', 'Affiliation': 'Usher Institute, University of Edinburgh, Edinburgh, United Kingdom.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Reilly', 'Affiliation': 'Scottish Recovery Network, Glasgow, United Kingdom.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Schwannauer', 'Affiliation': 'School of Health and Social Sciences, University of Edinburgh, Edinburgh, United Kingdom.'}, {'ForeName': 'Swaran P', 'Initials': 'SP', 'LastName': 'Singh', 'Affiliation': 'Division of Mental Health and Wellbeing, University of Warwick, Warwick, United Kingdom.'}, {'ForeName': 'Lesley', 'Initials': 'L', 'LastName': 'Smith', 'Affiliation': 'Scottish Recovery Network, Glasgow, United Kingdom.'}, {'ForeName': 'Suresh', 'Initials': 'S', 'LastName': 'Sundram', 'Affiliation': 'Monash University, Melbourne, Australia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Thomson', 'Affiliation': 'Glasgow Institute of Health and Wellbeing, Glasgow Mental Health Research Facility, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Thompson', 'Affiliation': 'Orygen, The National Centre of Excellence in Youth Mental Health, Melbourne, Australia.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Whitehill', 'Affiliation': 'Glasgow Institute of Health and Wellbeing, Glasgow Mental Health Research Facility, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Wilson-Kay', 'Affiliation': 'Glasgow Institute of Health and Wellbeing, Glasgow Mental Health Research Facility, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Williams', 'Affiliation': 'Glasgow Institute of Health and Wellbeing, Glasgow Mental Health Research Facility, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Yung', 'Affiliation': 'Division of Psychology and Mental Health, School of Health Sciences, University of Manchester, Manchester, United Kingdom.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Farhall', 'Affiliation': 'La Trobe University, Melbourne, Australia.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Gleeson', 'Affiliation': 'Australian Catholic University, Melbourne, Australia.'}]",JMIR research protocols,['10.2196/15058'] 875,31808151,Reversal of neuromuscular blockade with sugammadex during continuous administration of anaesthetic agents: a double-blind randomised crossover study using the bispectral index.,"Sugammadex, a specific reversal agent for steroidal neuromuscular blocking drugs, has on occasion been reported to be associated with clinical signs of awakening. We performed a study to systematically search for an increase in bispectral index values and signs of awakening in patients maintained under general anaesthesia following sugammadex administration. Patients, scheduled to receive general anaesthesia with neuromuscular blockade, were included in this double-blind randomised crossover study. After surgery was completed, and while the train-of-four ratio was zero, intravenous anaesthesia was continued with the aim of maintaining the bispectral index in the range of 40-60. Patients then received either sugammadex 4 mg.kg -1 or saline. In cases of incomplete reversal of neuromuscular blockade after 5 min, patients received the other drug. Bispectral index and train-of-four monitoring were recorded every minute and clinical signs of awakening noted. Fifty-one patients completed the study. Median (IQR [range]) bispectral index values increased after sugammadex administration from 49 (43-53 [38-64]) to 63 (53-80 [45-97]) (p < 0.01) with an increase of ≥ 20 in 22 patients; 14 (27%) patients had clinical signs of awakening. Saline had no effect on bispectral index values, clinical signs of awakening or degree of neuromuscular blockade. This study confirms that reversal of neuromuscular blockade with sugammadex may be associated with clinical signs of awakening despite maintenance of anaesthesia. Intravenous anaesthesia should be maintained until complete recovery of muscle function is achieved, especially when sugammadex is administered.",2020,"Saline had no effect on bispectral index values, clinical signs of awakening or degree of neuromuscular blockade.","['Fifty-one patients completed the study', 'patients maintained under general anaesthesia following sugammadex administration', 'Patients, scheduled to receive general anaesthesia with neuromuscular blockade']","['sugammadex', 'sugammadex 4\xa0mg.kg -1 or saline', 'anaesthetic agents', 'Sugammadex', 'Saline']","['bispectral index values', 'clinical signs of awakening', 'Median (IQR [range', 'bispectral index values and signs of awakening', 'bispectral index values, clinical signs of awakening or degree of neuromuscular blockade', 'Bispectral index and train-of-four monitoring']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1314677', 'cui_str': 'Maintained'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C1700695', 'cui_str': 'Sugammadex'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0002915', 'cui_str': 'General Anesthesia'}, {'cui': 'C0235062', 'cui_str': 'Neuromuscular Block'}]","[{'cui': 'C1700695', 'cui_str': 'Sugammadex'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0002932', 'cui_str': 'Anesthetic Drugs'}, {'cui': 'C0450442', 'cui_str': 'Agent (attribute)'}]","[{'cui': 'C1301882', 'cui_str': 'Bispectral index'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0311392', 'cui_str': 'Sign'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C1720052', 'cui_str': 'Awakening'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C0235062', 'cui_str': 'Neuromuscular Block'}, {'cui': 'C1301770', 'cui_str': 'Train-of-Four Monitoring'}]",51.0,0.555859,"Saline had no effect on bispectral index values, clinical signs of awakening or degree of neuromuscular blockade.","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Le Guen', 'Affiliation': 'Department of Anaesthesiology, Hospital Foch, Suresnes and University Versailles, Saint-Quentin en Yvelines, France.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Roussel', 'Affiliation': 'Department of Anaesthesiology, Hospital Foch, Suresnes and University Versailles, Saint-Quentin en Yvelines, France.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Chazot', 'Affiliation': 'Department of Anaesthesiology, Hospital Foch, Suresnes and University Versailles, Saint-Quentin en Yvelines, France.'}, {'ForeName': 'G A', 'Initials': 'GA', 'LastName': 'Dumont', 'Affiliation': 'Department of Electrical and Computer Engineering, University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Liu', 'Affiliation': 'Department of Anaesthesiology, Hospital Foch, Suresnes and University Versailles, Saint-Quentin en Yvelines, France.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Fischler', 'Affiliation': 'Department of Anaesthesiology, Hospital Foch, Suresnes and University Versailles, Saint-Quentin en Yvelines, France.'}]",Anaesthesia,['10.1111/anae.14897'] 876,30979666,Outcome of a psychosocial health promotion intervention aimed at improving physical health and reducing alcohol use in patients with schizophrenia and psychotic disorders (MINT).,"BACKGROUND Life expectancy is reduced by 19 years in men and 17 in women with psychosis in Sweden, largely due to cardiovascular disease. AIM Assess whether a psychosocial health promotion intervention improves cardiometabolic risk factors, quality of life, and severity of illness in patients with psychotic disorders more than treatment as usual. METHODS A pragmatic intervention trial testing a manual-based multi-component health promotion intervention targeting patients with psychosis. The Swedish intervention was adapted from IMPaCT therapy, a health-promotion program based on motivational interviewing and cognitive behavioral therapy, designed to be incorporated into routine care. The intervention group consisted of 119 patients and the control group of 570 patients from specialized psychosis departments. Outcome variables were assessed 6 months before intervention during the run-in period, again at the start of intervention, and 12 months after the intervention began. The control group received treatment as usual. RESULTS The intervention had no significant effect on any of the outcome variables. However, BMI, waist circumference, systolic BP, heart rate, HbA1c, general health, and Clinical Global Impressions Scale score improved significantly during the run-in period before the start of the active intervention (observer effect). The multi-component design meant that treatment effects could only be calculated for the intervention as a whole. CONCLUSION The results of the intervention are similar to those of the U.K. IMPaCT study, in which the modular health-promotion intervention had little effect on cardiovascular risk indicators. However, in the current study, the run-in period had a positive effect on cardiometabolic risk factors.",2019,The intervention had no significant effect on any of the outcome variables.,"['patients with schizophrenia and psychotic disorders (MINT', 'patients with psychosis', '19\u202fyears in men and 17 in women with psychosis in Sweden, largely due to cardiovascular disease', '119 patients and the control group of 570 patients from specialized psychosis departments', 'patients with psychotic disorders more than treatment as usual']","['psychosocial health promotion intervention', 'manual-based multi-component health promotion intervention', 'IMPaCT therapy, a health-promotion program based on motivational interviewing and cognitive behavioral therapy']","['cardiovascular risk indicators', 'cardiometabolic risk factors', 'cardiometabolic risk factors, quality of life, and severity of illness', 'BMI, waist circumference, systolic BP, heart rate, HbA1c, general health, and Clinical Global Impressions Scale score']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C0033975', 'cui_str': 'Psychoses'}, {'cui': 'C0452249', 'cui_str': 'Mint - sweet'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0018738', 'cui_str': 'Health Promotion'}, {'cui': 'C0175674', 'cui_str': 'Manual (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C3266262', 'cui_str': 'Multi'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0683474', 'cui_str': 'Motivational Interviewing'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}]","[{'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0034380'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0221423', 'cui_str': 'Illness (finding)'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C3639708', 'cui_str': 'Clinical global impression scale'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",570.0,0.0178365,The intervention had no significant effect on any of the outcome variables.,"[{'ForeName': 'Jeanette', 'Initials': 'J', 'LastName': 'Westman', 'Affiliation': 'Dept of Neurobiology, Care Sciences and Society, Karolinska Institutet, Stockholm, Sweden; Academic Primary Health Care Centre, Region Stockholm, Sweden. Electronic address: jeanette.westman@ki.se.'}, {'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'Eberhard', 'Affiliation': ""Division of Psychiatry, Dept of Clinical Sciences, Lund University, Lund, Sweden; Institute of Psychiatry, Psychology and Neuroscience, King's College London, UK.""}, {'ForeName': 'Fiona P', 'Initials': 'FP', 'LastName': 'Gaughran', 'Affiliation': ""Institute of Psychiatry, Psychology and Neuroscience, King's College London, UK; South London and Maudsley NHS Foundation Trust, London, UK.""}, {'ForeName': 'Lennart', 'Initials': 'L', 'LastName': 'Lundin', 'Affiliation': 'Sahlgrenska University Hospital, Gothenburg, Sweden; Swedish Schizophrenia Fellowship, Stockholm, Sweden.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Stenmark', 'Affiliation': 'Division of Psychiatry, Dept of Clinical Sciences, Lund University, Lund, Sweden.'}, {'ForeName': 'Gunnar', 'Initials': 'G', 'LastName': 'Edman', 'Affiliation': 'Norrtälje Hospital, Tiohundra AB, Norrtälje, Sweden; Dept of Clinical Sciences, Danderyd Hospital, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Sven V', 'Initials': 'SV', 'LastName': 'Eriksson', 'Affiliation': 'Department of Internal Medicine, Enköping Hospital, Enköping, Sweden; Aleris Specialist Care, Gothenburg, Sweden.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Jedenius', 'Affiliation': 'Dept of Neurobiology, Care Sciences and Society, Karolinska Institutet, Stockholm, Sweden; Division of Psychiatry, Dept of Clinical Sciences, Lund University, Lund, Sweden.'}, {'ForeName': 'Pia', 'Initials': 'P', 'LastName': 'Rydell', 'Affiliation': 'Sahlgrenska University Hospital, Gothenburg, Sweden.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Overgaard', 'Affiliation': 'Sahlgrenska University Hospital, Gothenburg, Sweden.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Abrams', 'Affiliation': 'Sahlgrenska University Hospital, Gothenburg, Sweden.'}, {'ForeName': 'Kathryn E', 'Initials': 'KE', 'LastName': 'Greenwood', 'Affiliation': 'School of Psychology, University of Sussex, Brighton, UK; Sussex Partnership NHS Foundation Trust, UK.'}, {'ForeName': 'Shubulade', 'Initials': 'S', 'LastName': 'Smith', 'Affiliation': ""Institute of Psychiatry, Psychology and Neuroscience, King's College London, UK; South London and Maudsley NHS Foundation Trust, London, UK.""}, {'ForeName': 'Khalida', 'Initials': 'K', 'LastName': 'Ismail', 'Affiliation': ""Institute of Psychiatry, Psychology and Neuroscience, King's College London, UK.""}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Murray', 'Affiliation': ""Institute of Psychiatry, Psychology and Neuroscience, King's College London, UK; South London and Maudsley NHS Foundation Trust, London, UK.""}, {'ForeName': 'Urban', 'Initials': 'U', 'LastName': 'Ösby', 'Affiliation': 'Dept of Molecular Medicine and Surgery, Karolinska Institutet, Stockholm, Sweden; Center for Molecular Medicine, Karolinska University Hospital, Stockholm, Sweden.'}]",Schizophrenia research,['10.1016/j.schres.2019.03.026'] 877,31873783,Are the Effects of High-Intensity Exercise Training Different in Patients with COPD Versus COPD+Asthma Overlap?,"PURPOSE This study aimed to investigate whether patients with chronic obstructive pulmonary disease (COPD) presenting asthma overlap (ACO) benefit similarly in comparison to patients with only COPD after a 12-week high-intensity exercise training (ET) program. METHODS Subjects with a diagnosis of COPD alone or ACO were evaluated and compared before and after a high-intensity ET program composed of walking and cycling plus strengthening exercises of the upper and lower limbs (3 days/week, 3 months, 36 sessions). Assessments included spirometry, bioelectrical impedance, 6-min walk test (6MWT), London Chest Activity of Daily Living Scale (LCADL), Hospital anxiety and depression Scale, modified Medical Research Council Scale (mMRC), Saint George Respiratory Questionnaire (SGRQ), and respiratory and peripheral muscle strength [manovacuometry and 1-repetition maximum test (quadriceps femoris, biceps and triceps brachialis), respectively]. ACO was defined according to Sin et al. (Eur Respir J 48(3):664-673, 2016). RESULTS The sample was composed of 74 subjects (57% male, age 67 ± 8 years, BMI 26 (21-32) kg/m 2 , FEV 1 47 ± 17%predicted), and 12 (16%) of them were classified as presenting ACO. Both groups improved pulmonary function, 6MWT, peripheral and inspiratory muscle strength, LCADL, and SGRQ after ET (p < 0.005 for all). There were no significant interactions between ACO and COPD on ET effects (p > 0.05 for all). Likewise, there was no difference in the proportion of patients achieving the minimum clinical important difference for 6MWT and mMRC. CONCLUSION High-intensity exercise training generates similar benefits in patients with COPD regardless of whether presenting asthma overlap or not.",2020,"Both groups improved pulmonary function, 6MWT, peripheral and inspiratory muscle strength, LCADL, and SGRQ after ET (p < 0.005 for all).","['Patients with COPD Versus COPD+Asthma Overlap', 'patients with COPD regardless of whether presenting asthma overlap or not', 'patients with chronic obstructive pulmonary disease (COPD) presenting asthma overlap (ACO) benefit similarly in comparison to patients with only COPD after a 12-week high', 'Subjects with a diagnosis of COPD alone or ACO were evaluated and compared before and after a', '74 subjects (57% male, age 67\u2009±\u20098\xa0years, BMI 26 (21-32) kg/m 2 , FEV 1']","['high-intensity ET program composed of walking and cycling plus strengthening exercises of the upper and lower limbs', 'intensity exercise training (ET) program', 'High-intensity exercise training', 'High-Intensity Exercise Training']","['ACO and COPD on ET effects', 'ACO', 'pulmonary function, 6MWT, peripheral and inspiratory muscle strength, LCADL, and SGRQ after ET', 'spirometry, bioelectrical impedance, 6-min walk test (6MWT), London Chest Activity of Daily Living Scale (LCADL), Hospital anxiety and depression Scale, modified Medical Research Council Scale (mMRC), Saint George Respiratory Questionnaire (SGRQ), and respiratory and peripheral muscle strength [manovacuometry and 1-repetition maximum test (quadriceps femoris, biceps and triceps brachialis), respectively']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C0185027', 'cui_str': 'Imbrication (procedure)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}]","[{'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0452260', 'cui_str': 'Muscular strength development exercise (regime/therapy)'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}]","[{'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C0205100', 'cui_str': 'Peripheral (qualifier value)'}, {'cui': 'C0004048', 'cui_str': 'Inhalation'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0037981', 'cui_str': 'Spirometry'}, {'cui': 'C0162536', 'cui_str': 'Bioelectrical Impedance'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0023973', 'cui_str': 'London'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C0001288', 'cui_str': 'ADL'}, {'cui': 'C0222045'}, {'cui': 'C0451221', 'cui_str': 'Hospital anxiety and depression scale (assessment scale)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0079816', 'cui_str': 'Medical Research'}, {'cui': 'C0242823', 'cui_str': 'Saints'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}]",74.0,0.0153924,"Both groups improved pulmonary function, 6MWT, peripheral and inspiratory muscle strength, LCADL, and SGRQ after ET (p < 0.005 for all).","[{'ForeName': 'Antenor', 'Initials': 'A', 'LastName': 'Rodrigues', 'Affiliation': 'Laboratory of Research in Respiratory Physiotherapy - LFIP, Department of Physiotherapy, Londrina State University, Londrina, Brazil.'}, {'ForeName': 'Joice Mara', 'Initials': 'JM', 'LastName': 'de Oliveira', 'Affiliation': 'Center for Research in Biological and Health Sciences, University of Northern Parana, Londrina, Brazil.'}, {'ForeName': 'Karina Couto', 'Initials': 'KC', 'LastName': 'Furlanetto', 'Affiliation': 'Center for Research in Biological and Health Sciences, University of Northern Parana, Londrina, Brazil.'}, {'ForeName': 'Felipe Vilaça Cavallari', 'Initials': 'FVC', 'LastName': 'Machado', 'Affiliation': 'Laboratory of Research in Respiratory Physiotherapy - LFIP, Department of Physiotherapy, Londrina State University, Londrina, Brazil.'}, {'ForeName': 'Letícia Fernandes', 'Initials': 'LF', 'LastName': 'Belo', 'Affiliation': 'Laboratory of Research in Respiratory Physiotherapy - LFIP, Department of Physiotherapy, Londrina State University, Londrina, Brazil.'}, {'ForeName': 'Lorena Paltanin', 'Initials': 'LP', 'LastName': 'Schneider', 'Affiliation': 'Laboratory of Research in Respiratory Physiotherapy - LFIP, Department of Physiotherapy, Londrina State University, Londrina, Brazil.'}, {'ForeName': 'Andrea Akemi', 'Initials': 'AA', 'LastName': 'Morita', 'Affiliation': 'Laboratory of Research in Respiratory Physiotherapy - LFIP, Department of Physiotherapy, Londrina State University, Londrina, Brazil.'}, {'ForeName': 'Ana Carolina', 'Initials': 'AC', 'LastName': 'Andrelo', 'Affiliation': 'Laboratory of Research in Respiratory Physiotherapy - LFIP, Department of Physiotherapy, Londrina State University, Londrina, Brazil.'}, {'ForeName': 'Jéssica', 'Initials': 'J', 'LastName': 'Fonseca', 'Affiliation': 'Laboratory of Research in Respiratory Physiotherapy - LFIP, Department of Physiotherapy, Londrina State University, Londrina, Brazil.'}, {'ForeName': 'Igor Lopes', 'Initials': 'IL', 'LastName': 'Brito', 'Affiliation': 'Laboratory of Research in Respiratory Physiotherapy - LFIP, Department of Physiotherapy, Londrina State University, Londrina, Brazil.'}, {'ForeName': 'Thaís', 'Initials': 'T', 'LastName': 'Paes', 'Affiliation': 'Laboratory of Research in Respiratory Physiotherapy - LFIP, Department of Physiotherapy, Londrina State University, Londrina, Brazil.'}, {'ForeName': 'Josiane Marques', 'Initials': 'JM', 'LastName': 'Felcar', 'Affiliation': 'Center for Research in Biological and Health Sciences, University of Northern Parana, Londrina, Brazil.'}, {'ForeName': 'Vanessa Suziane', 'Initials': 'VS', 'LastName': 'Probst', 'Affiliation': 'Laboratory of Research in Respiratory Physiotherapy - LFIP, Department of Physiotherapy, Londrina State University, Londrina, Brazil.'}, {'ForeName': 'Nidia Aparecida', 'Initials': 'NA', 'LastName': 'Hernandes', 'Affiliation': 'Laboratory of Research in Respiratory Physiotherapy - LFIP, Department of Physiotherapy, Londrina State University, Londrina, Brazil.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Pitta', 'Affiliation': 'Laboratory of Research in Respiratory Physiotherapy - LFIP, Department of Physiotherapy, Londrina State University, Londrina, Brazil. fabiopitta@uol.com.br.'}]",Lung,['10.1007/s00408-019-00311-7'] 878,30790298,Use of a novel vessel-sealing device for peripheral lung biopsy and lung lobectomy in a cadaveric model.,"OBJECTIVE To evaluate the Caiman vessel-sealing device for peripheral lung biopsy and total lung lobectomy in cadaveric canine lung lobes. MATERIAL AND METHODS Twelve lung lobes were randomly assigned to peripheral lung biopsy (n=6) or total lung lobectomy (n=6) with the 12-mm Caiman vessel-sealing device. Lungs were connected to a ventilator set at 10 breaths per minute with an initial pressure of 5 cm H 2 O during the procedure. The lungs were submerged in water for leak testing and the pressure increased until leakage occurred. RESULTS Mean airway pressure at which leakage occurred was 39.17 ±13.20 cm H 2 O for peripheral lung biopsies and 38.33 ±13.67 cm H 2 O for total lung lobectomies. None of the samples leaked below 25 cm H 2 O, which is well above the physiologic airway pressure. Histologically, the largest bronchial diameter at the sealed area was 8.84 mm and the extent of collateral damage was approximately 2.7 mm in all specimens. CLINICAL SIGNIFICANCE The Caiman vessel-sealing device was successfully used for peripheral lung biopsy and total lung lobectomy in cadaveric canine lung lobes. All sealed lung lobes tolerated supra-physiologic airway pressure, displayed minimal collateral damage, and were of good diagnostic quality. Further experimental studies are needed to evaluate the clinical safety of the device for peripheral lung biopsy or total lung lobectomy.",2019,The Caiman vessel-sealing device was successfully used for peripheral lung biopsy and total lung lobectomy in cadaveric canine lung lobes.,"['peripheral lung biopsy and lung lobectomy in a cadaveric model', 'cadaveric canine lung lobes', 'peripheral lung biopsy and total lung lobectomy in cadaveric canine lung lobes', 'Twelve lung lobes']","['peripheral lung biopsy (n=6) or total lung lobectomy (n=6) with the 12-mm Caiman vessel-sealing device', 'novel vessel-sealing device', 'Caiman vessel-sealing device']","['Mean airway pressure at which leakage', 'collateral damage']","[{'cui': 'C0205100', 'cui_str': 'Peripheral (qualifier value)'}, {'cui': 'C0189485', 'cui_str': 'Biopsy of lung (procedure)'}, {'cui': 'C0189497', 'cui_str': 'Lobectomy of lung (procedure)'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C0024109', 'cui_str': 'Lung'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]","[{'cui': 'C0205100', 'cui_str': 'Peripheral (qualifier value)'}, {'cui': 'C0189485', 'cui_str': 'Biopsy of lung (procedure)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0189497', 'cui_str': 'Lobectomy of lung (procedure)'}, {'cui': 'C0079078', 'cui_str': 'Caimans'}, {'cui': 'C0148346', 'cui_str': 'Vessel'}, {'cui': 'C0036492', 'cui_str': 'Seal (organism)'}, {'cui': 'C0220819', 'cui_str': 'devices'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0428719', 'cui_str': 'Airway pressure'}, {'cui': 'C0015376', 'cui_str': 'Extravasation (morphologic abnormality)'}, {'cui': 'C1275670', 'cui_str': 'Collateral'}, {'cui': 'C0010957', 'cui_str': 'Damage (morphologic abnormality)'}]",,0.017744,The Caiman vessel-sealing device was successfully used for peripheral lung biopsy and total lung lobectomy in cadaveric canine lung lobes.,"[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Brückner', 'Affiliation': 'Blå Stjärnans Djursjukhus, Göteborg, 41707, Sweden.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Heblinski', 'Affiliation': 'Specialist Djursjukhus Strömsholm, Strömsholm, 73494, Sweden.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Henrich', 'Affiliation': 'Institut fuer Veterinärpathologie, Justus-Liebig-University of Gießen, Gießen, 35392, Germany.'}]",The Journal of small animal practice,['10.1111/jsap.12985'] 879,31837721,Evaluation of a multi-component and multi-agent intervention to improve classroom social relationships among early elementary school-age children.,"We present the preliminary evaluation of a comprehensive, multi-component and multi-agent 2-year classroom intervention to enhance children's relationships with their peers and teachers among early elementary school students in Spain. The intervention contained universal components directed to the whole class plus targeted components for children with peer problems. Using a quasi-experimental design, 229 children (in 10 classrooms) formed a comparison group whose teachers engaged in their typical practices, followed the next year by 214 children (in 9 classrooms) who received the intervention. Children completed a sociometric procedure, and reported their self-perceptions of peer functioning and their relationship quality with teachers at the beginning of 1st grade (pretest) and the end of 2nd grade (posttest; 93% retention). After statistical control of pretest functioning, by posttest those in the intervention group received fewer negative sociometric nominations, perceived themselves to receive fewer negative sociometric nominations and to have greater overall peer acceptance, and reported their teachers to have greater warmth and organization, compared to children in the comparison group. However, intervention group children also received fewer positive sociometric nominations (as well as perceived themselves to receive fewer positive nominations) than comparison group children. Target children, selected for being disliked by peers, received accentuated benefits from the intervention on the outcome variables of fewer negative nominations received and greater teacher warmth. Implications for practice are discussed.",2019,"Target children, selected for being disliked by peers, received accentuated benefits from the intervention on the outcome variables of fewer negative nominations received and greater teacher warmth.","[""children's relationships with their peers and teachers among early elementary school students in Spain"", 'early elementary school-age children', '229 children (in 10 classrooms) formed a comparison group whose teachers engaged in their typical practices, followed the next year by 214 children (in 9 classrooms) who received the intervention']","['multi-component and multi-agent intervention', 'comprehensive, multi-component and multi-agent 2-year classroom intervention']","['overall peer acceptance', 'positive sociometric nominations', 'negative sociometric nominations', 'classroom social relationships']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439849', 'cui_str': 'Relationships (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0221457', 'cui_str': 'Teacher (occupation)'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married (finding)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0043237', 'cui_str': 'WHO'}]","[{'cui': 'C3266262', 'cui_str': 'Multi'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0450442', 'cui_str': 'Agent (attribute)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0439849', 'cui_str': 'Relationships (qualifier value)'}]",229.0,0.0199331,"Target children, selected for being disliked by peers, received accentuated benefits from the intervention on the outcome variables of fewer negative nominations received and greater teacher warmth.","[{'ForeName': 'Francisco J', 'Initials': 'FJ', 'LastName': 'García Bacete', 'Affiliation': 'Department of Developmental, Educational, and Social Psychology and Methodology, Jaume I University, Castellón, Spain. Electronic address: fgarcia@uji.es.'}, {'ForeName': 'Ghislaine', 'Initials': 'G', 'LastName': 'Marande', 'Affiliation': 'Department of Developmental, Educational, and Social Psychology and Methodology, Jaume I University, Castellón, Spain.'}, {'ForeName': 'Amori Yee', 'Initials': 'AY', 'LastName': 'Mikami', 'Affiliation': 'Department of Psychology, University of British Columbia, Vancouver, Canada.'}]",Journal of school psychology,['10.1016/j.jsp.2019.09.001'] 880,31070954,Water deprivation does not augment sympathetic or pressor responses to sciatic afferent nerve stimulation in rats or to static exercise in humans.,"Excess dietary salt intake excites central sympathetic networks, which may be related to plasma hypernatremia. Plasma hypernatremia also occurs following water deprivation (WD). The purpose of this study was to test the hypothesis that WD induces hypernatremia and consequently augments sympathetic and pressor responses to sympathoexcitatory stimuli in rats and humans. Sympathetic nerve activity (SNA) and arterial blood pressure (ABP) responses to sciatic afferent nerve stimulation (2-20 Hz) and chemical stimulation of the rostral ventrolateral medulla (RVLM) were assessed in rats after 48 h of WD and compared with normally hydrated control rats (CON). In a parallel randomized-crossover human experiment ( n = 13 healthy young adults), sympathetic (microneurography) and pressor (photoplethysmography) responses to static exercise were compared between 16-h WD and CON conditions. In rats, plasma [Na + ] was significantly higher in WD versus CON [136 ± 2 vs. 144 ± 2 (SD) mM, P < 0.01], but sciatic afferent nerve stimulation produced similar increases in renal SNA [5 Hz, 174 ± 34 vs. 169 ± 49% (SD), n = 6-8] and mean ABP [5 Hz, 21 ± 6 vs. 18 ± 7 (SD mmHg, n = 6-8]. RVLM injection of l-glutamate also produced similar increases in SNA and ABP in WD versus CON rats. In humans, WD increased serum [Na + ] [140.6 ± 2.1 vs. 142.1 ± 1.9 mM (SD), P = 0.02] but did not augment sympathetic [muscle SNA: change from baseline (Δ) 6 ± 7 vs. 5 ± 7 (SD) bursts/min, P = 0.83] or mean ABP [Δ 12 ± 5 vs. 11 ± 8 (SD) mmHg, P = 0.73; WD vs. CON for all results] responses during the final minute of exercise. These findings suggest that despite eliciting relative hypernatremia, WD does not augment sympathetic or pressor responses to sciatic afferent stimulation in rats or to static exercise in humans. NEW & NOTEWORTHY Excess dietary salt intake excites central sympathetic networks, which may be related to plasma hypernatremia. Plasma hypernatremia also occurs following water deprivation (WD). We sought to determine whether plasma hypernatremia/hyperosmolality induced by WD augments sympathetic and pressor responses to sympathoexcitatory stimuli. Our findings suggest that WD does not augment sympathetic or pressor responses to sciatic afferent nerve stimulation in rats or to static exercise in humans.",2019,"In rats, plasma [Na + ] was significantly higher in WD versus CON (136±2 vs. 144±2 mM, p<0.01), but sciatic afferent nerve stimulation produced similar increases in renal SNA (5Hz, 174±34 vs. 169±49%, n=6-8) and mean ABP (5Hz, 21±6","['rats or to static exercise in humans', 'rats after 48h of WD and compared to normally hydrated control rats (CON', 'n=13 healthy young adults']","['sympathetic (microneurography) and pressor (photoplethysmography) responses to static exercise', 'CON', 'sciatic afferent nerve stimulation (2-20 Hz) and chemical stimulation of the rostral ventrolateral medulla (RVLM']","['serum [Na + ', 'Sympathetic nerve activity (SNA) and arterial blood pressure (ABP) responses', 'plasma [Na + ', 'renal SNA', 'SNA and ABP', 'mean ABP']","[{'cui': 'C0034721', 'cui_str': 'Rats'}, {'cui': 'C0441463', 'cui_str': 'Static (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C0441463', 'cui_str': 'Static (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0205115', 'cui_str': 'Afferent (qualifier value)'}, {'cui': 'C0027740', 'cui_str': 'Nerve structure'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0038337', 'cui_str': 'Stimulation, Chemical'}, {'cui': 'C3163631', 'cui_str': 'Rostral'}, {'cui': 'C3266730', 'cui_str': 'Ventrolateral'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0459521', 'cui_str': 'Sympathetic nerve structure (body structure)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C1272641', 'cui_str': 'Arterial Tension'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",13.0,0.0954453,"In rats, plasma [Na + ] was significantly higher in WD versus CON (136±2 vs. 144±2 mM, p<0.01), but sciatic afferent nerve stimulation produced similar increases in renal SNA (5Hz, 174±34 vs. 169±49%, n=6-8) and mean ABP (5Hz, 21±6","[{'ForeName': 'Joseph C', 'Initials': 'JC', 'LastName': 'Watso', 'Affiliation': 'Department of Kinesiology and Applied Physiology, University of Delaware , Newark, Delaware.'}, {'ForeName': 'Matthew C', 'Initials': 'MC', 'LastName': 'Babcock', 'Affiliation': 'Department of Kinesiology and Applied Physiology, University of Delaware , Newark, Delaware.'}, {'ForeName': 'Austin T', 'Initials': 'AT', 'LastName': 'Robinson', 'Affiliation': 'Department of Kinesiology and Applied Physiology, University of Delaware , Newark, Delaware.'}, {'ForeName': 'Kamila U', 'Initials': 'KU', 'LastName': 'Migdal', 'Affiliation': 'Department of Kinesiology and Applied Physiology, University of Delaware , Newark, Delaware.'}, {'ForeName': 'Megan M', 'Initials': 'MM', 'LastName': 'Wenner', 'Affiliation': 'Department of Kinesiology and Applied Physiology, University of Delaware , Newark, Delaware.'}, {'ForeName': 'Sean D', 'Initials': 'SD', 'LastName': 'Stocker', 'Affiliation': 'Department of Medicine, University of Pittsburgh , Pittsburgh, Pennsylvania.'}, {'ForeName': 'William B', 'Initials': 'WB', 'LastName': 'Farquhar', 'Affiliation': 'Department of Kinesiology and Applied Physiology, University of Delaware , Newark, Delaware.'}]","Journal of applied physiology (Bethesda, Md. : 1985)",['10.1152/japplphysiol.00005.2019'] 881,31733759,Effects of core strengthening on balance in university judo athletes.,"BACKGROUND Core strengthening prepares the body in an integral, safe and efficient way, favoring balance and postural control; physical abilities constantly demanded in sports, especially in body contact modalities, such as Judo. OBJECTIVE This study investigated the effects of core strengthening on balance in university judo athletes. METHODS Eighteen athletes from the University of Southern Santa Catarina (UNISUL) were randomly allocated into two groups: experimental (n = 9) and control (n = 9). Experimental group athletes were submitted to a core strengthening protocol (30-min sessions, twice a week for 5 consecutive weeks). Evaluations consisted of Stabilometic (center of pressure behavior parameters: total area in mm 2 , laterolateral and anteroposterior width in mm) and baropodometric analysis [peak pressure: obtained during a 30-s acquisition period and expressed by foot area, i.e., (a) forefoot (metatarsal heads and toes); and (b) hindfoot (calcaneus region, distal third of the foot)]. Right/left foot ratios were calculated as relative percentages and used for the analysis. The analyzes were performed at baseline and after 5 weeks of core strengthening. The athletes were evaluated in two situations: eyes-open and eyes-closed. RESULTS Total right/left foot ratio pressure, right/left fore and hindfoot ratio pressure, as well as anteroposterior width measurements were statistically smaller in the experimental group. CONCLUSION Although the results obtained showed that core strengthening presents certain benefits, these data alone are not enough to confirm its effects upon postural oscillation in university judo athletes.",2019,"METHODS Eighteen athletes from the University of Southern Santa Catarina (UNISUL) were randomly allocated into two groups: experimental (n = 9) and control (n = 9).","['university judo athletes', 'Eighteen athletes from the University of Southern Santa Catarina (UNISUL']",['core strengthening'],"['anteroposterior width measurements', 'Total right/left foot ratio pressure, right/left fore and hindfoot ratio pressure', 'Right/left foot ratios', 'Stabilometic (center of pressure behavior parameters: total area in mm 2 , laterolateral and anteroposterior width in mm) and baropodometric analysis [peak pressure']","[{'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0079650', 'cui_str': 'Judo'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C3715206', 'cui_str': 'Eighteen'}]","[{'cui': 'C0444669', 'cui_str': 'Core (qualifier value)'}]","[{'cui': 'C0487742', 'cui_str': 'Width (qualifier value)'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0205090', 'cui_str': 'Right (qualifier value)'}, {'cui': 'C0016504', 'cui_str': 'Foot'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C0230459', 'cui_str': 'Hindfoot (body structure)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0445174', 'cui_str': 'Peak pressure (qualifier value)'}]",18.0,0.0198386,"METHODS Eighteen athletes from the University of Southern Santa Catarina (UNISUL) were randomly allocated into two groups: experimental (n = 9) and control (n = 9).","[{'ForeName': 'Heloisa Schroeder', 'Initials': 'HS', 'LastName': 'Martins', 'Affiliation': 'Physical Therapy Graduate Program, University of Southern Santa Catarina (UNISUL), Palhoça, Santa Catarina, Brazil. Electronic address: daniel.martins4@unisul.br.'}, {'ForeName': 'Daniela Dero', 'Initials': 'DD', 'LastName': 'Lüdtke', 'Affiliation': 'Physical Therapy Graduate Program, University of Southern Santa Catarina (UNISUL), Palhoça, Santa Catarina, Brazil; Experimental Neuroscience Laboratory (LaNEx) and Health Sciences Postgraduate Program, University of Southern Santa Catarina, Palhoça, Santa Catarina, Brazil.'}, {'ForeName': 'Júlio', 'Initials': 'J', 'LastName': 'César de Oliveira Araújo', 'Affiliation': 'Physical Therapy Graduate Program, University of Southern Santa Catarina (UNISUL), Palhoça, Santa Catarina, Brazil.'}, {'ForeName': 'Francisco José', 'Initials': 'FJ', 'LastName': 'Cidral-Filho', 'Affiliation': 'Experimental Neuroscience Laboratory (LaNEx) and Health Sciences Postgraduate Program, University of Southern Santa Catarina, Palhoça, Santa Catarina, Brazil.'}, {'ForeName': 'Afonso Shiguemi', 'Initials': 'AS', 'LastName': 'Inoue Salgado', 'Affiliation': 'Experimental Neuroscience Laboratory (LaNEx) and Health Sciences Postgraduate Program, University of Southern Santa Catarina, Palhoça, Santa Catarina, Brazil; Integrative Physical Therapy Residency Program - Philadelphia University Center, Londrina, PR, Brazil.'}, {'ForeName': 'Frederic', 'Initials': 'F', 'LastName': 'Viseux', 'Affiliation': 'Laboratory of Industrial and Human Automation Control, Mechanical Engineering and Computer Sciences (LAMIH), Polytechnic University of Hauts-de-France and Center for Assessment and Treatment of Pain (CETD), General Hospital of Valenciennes, France.'}, {'ForeName': 'Daniel Fernandes', 'Initials': 'DF', 'LastName': 'Martins', 'Affiliation': 'Physical Therapy Graduate Program, University of Southern Santa Catarina (UNISUL), Palhoça, Santa Catarina, Brazil; Experimental Neuroscience Laboratory (LaNEx) and Health Sciences Postgraduate Program, University of Southern Santa Catarina, Palhoça, Santa Catarina, Brazil.'}]",Journal of bodywork and movement therapies,['10.1016/j.jbmt.2019.05.009'] 882,31733760,A randomized controlled pilot study of the effects of 6-week high intensity hatha yoga protocol on health-related outcomes among students.,"OBJECTIVE Modern hatha yoga exercises (YE) provide an alternative form of physical activity which may reduce stress, facilitate recovery and improve health. This study investigated the short-term effects of high intensity hatha yoga exercises (HIY) on health-related outcomes. METHODS A 6-week randomized controlled study was performed to compare HIY with a control group not changing their exercise behavior. Healthy students (N = 44; median age: 25 years, range 20-39 years; HIY: n = 21, including 3 men; control group: n = 23, including 3 men) novice to yoga participated in the intervention which included one weekly class and recommended home training. Participants provided self-reports in questionnaires before and after the intervention. Self-reports included anxiety and depression (Hospital Anxiety and Depression Scale), stress (Perceived Stress Scale), sleep quality (Pittsburgh Sleep Quality Index), insomnia (Insomnia Severity Index), subjective health complaints (Common Symptoms in General Practice Index) and self-rated health (single-item). RESULTS After the 6-week intervention, there were no between-group differences in anxiety, depression, stress, sleep or self-rated health. However, when investigating associations within the HIY-group, a higher HIY-dose was related to less depression (r = 0.47; p = 0.03), improved sleep quality (r = 0.55; p = 0.01), and less insomnia (r = 0.49; p = 0.02). CONCLUSIONS There were no short-term between-group effects of HIY on mental distress, sleep or self-rated health. However, within the HIY-group, a higher dose was associated with improved mental health in terms of depression and with improved sleep. Although future studies with larger samples are needed, these preliminary findings suggest short-term positive effects of HIY on health-related outcomes among students. TRIAL REGISTRATION NUMBER NCT01305096.",2019,"There were no short-term between-group effects of HIY on mental distress, sleep or self-rated health.","['students', 'Healthy students (N\u202f=\u202f44; median age: 25 years, range 20-39 years; HIY: n\u202f=\u202f21, including 3 men; control group: n\u202f=\u202f23, including 3 men']","['novice to yoga participated in the intervention which included one weekly class and recommended home training', 'high intensity hatha yoga exercises (HIY', '6-week high intensity hatha yoga protocol']","['anxiety, depression, stress, sleep or self-rated health', 'anxiety and depression (Hospital Anxiety and Depression Scale), stress (Perceived Stress Scale), sleep quality (Pittsburgh Sleep Quality Index), insomnia (Insomnia Severity Index), subjective health complaints (Common Symptoms in General Practice Index) and self-rated health (single-item', 'sleep quality', 'mental distress, sleep or self-rated health', 'insomnia', 'sleep', 'mental health']","[{'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0451221', 'cui_str': 'Hospital anxiety and depression scale (assessment scale)'}, {'cui': 'C0582653', 'cui_str': 'Perceived stress scale (assessment scale)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C3697468', 'cui_str': 'PSQI - Pittsburgh sleep quality index'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C4520529', 'cui_str': 'Insomnia severity index (assessment scale)'}, {'cui': 'C2936631', 'cui_str': 'Subjective Health'}, {'cui': 'C0205214', 'cui_str': 'Common (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0086343', 'cui_str': 'General Practice'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0235109', 'cui_str': 'Mental distress (finding)'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}]",,0.0439806,"There were no short-term between-group effects of HIY on mental distress, sleep or self-rated health.","[{'ForeName': 'Marian E', 'Initials': 'ME', 'LastName': 'Papp', 'Affiliation': 'Department of Neurobiology, Care Sciences and Society, Division of Family Medicine and Primary Care Sweden. Electronic address: marian.papp@ki.se.'}, {'ForeName': 'Malin', 'Initials': 'M', 'LastName': 'Nygren-Bonnier', 'Affiliation': 'Department of Neurobiology, Care Sciences and Society, Division of Physiotherapy, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Lennart', 'Initials': 'L', 'LastName': 'Gullstrand', 'Affiliation': 'University of Gothenburg, Department of Nutrition, Health and Sport Science, SE 405 30, Gothenburg, Sweden.'}, {'ForeName': 'Per E', 'Initials': 'PE', 'LastName': 'Wändell', 'Affiliation': 'Department of Neurobiology, Care Sciences and Society, Division of Family Medicine and Primary Care Sweden.'}, {'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Lindfors', 'Affiliation': 'Department of Psychology, Stockholm University, Frescati Hagväg 14, SE-106 91, Stockholm, Sweden.'}]",Journal of bodywork and movement therapies,['10.1016/j.jbmt.2019.05.013'] 883,31733763,Effect of manual compressive therapy on latent myofascial trigger point pressure pain thresholds.,"OBJECTIVE This study compared the effects of 90 s of manual compressive therapy (MCT) on latent myofascial trigger points (LTPs) for 3 sessions per week for 4 weeks to determine changes in individual pressure pain threshold (PPT). A total of 30 (15 males, 15 females; age = 22 ± 4 y/o, height = 175 ± 18 cm, weight = 162.5 ± 57.5 kg) symptomatic subjects with LTPs volunteered for the study. METHODS PPT was measured at baseline and pre- and post-treatment for all 12 sessions with a pressure algometer across the 4-week treatment time frame. The MCT was applied to the control group on their LTP at pressure intended to provide a sham condition (1/10 on verbalized analog scale (VAS)). Two experimental groups had MCT applied either directly on the LTP (d-TP) or in close-proximity to their LTP (cp-TP) at moderate pressure (7/10 on VAS). RESULTS There was a significant increase in PPT from the first through twelfth treatment sessions (p < 0.001, partial η 2  = 0.914). A significant increase in PPTs between treatment groups was acutely observed from pre- to post-therapy tests (p = 0.001, partial η 2  = 0.146). The differences between pre- versus post-treatment PPT measures indicated significant differences (d-TP vs. control, p < 0.001; cp-TP vs. control, p = 0.007). No differences were observed between experimental groups (p = 0.215). CONCLUSIONS PPT continued to increase after several weeks of MCT when applied directly on or within 2.5 cm of an identified LTP compared to control.",2019,"There was a significant increase in PPT from the first through twelfth treatment sessions (p < 0.001, partial η 2  = 0.914).","['A total of 30 (15 males, 15 females; age\u202f=\u202f22\u202f±\u202f4\u202fy/o, height\u202f=\u202f175\u202f±\u202f18\u202fcm, weight\u202f=\u202f162.5\u202f±\u202f57.5\u202fkg) symptomatic subjects with LTPs volunteered for the study']","['90\u202fs of manual compressive therapy (MCT', 'MCT', 'manual compressive therapy']","['individual pressure pain threshold (PPT', 'latent myofascial trigger points (LTPs', 'PPT', 'latent myofascial trigger point pressure pain thresholds', 'PPTs']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517605', 'cui_str': '175'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0175674', 'cui_str': 'Manual (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1173173', 'cui_str': 'N-methanocarbathymidine'}]","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0162703', 'cui_str': 'Pain Threshold'}, {'cui': 'C0205275', 'cui_str': 'Latent (qualifier value)'}, {'cui': 'C0458343', 'cui_str': 'Trigger point (body structure)'}]",,0.0111015,"There was a significant increase in PPT from the first through twelfth treatment sessions (p < 0.001, partial η 2  = 0.914).","[{'ForeName': 'Jack W', 'Initials': 'JW', 'LastName': 'Ransone', 'Affiliation': 'College of William and Mary, Department of Athletics, Williamsburg, VA, USA. Electronic address: jwransone@wm.edu.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Schmidt', 'Affiliation': 'Texas State University, Department of Human Performance, San Marcos, TX, USA.'}, {'ForeName': 'Scott K', 'Initials': 'SK', 'LastName': 'Crawford', 'Affiliation': 'University of Wisconsin, Department of Orthopedics & Rehabilitation, Madison, WI, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Walker', 'Affiliation': 'Texas State University, Department of Human Performance, San Marcos, TX, USA.'}]",Journal of bodywork and movement therapies,['10.1016/j.jbmt.2019.06.011'] 884,31901945,Inpatient multimodal occupational rehabilitation reduces sickness absence among individuals with musculoskeletal and common mental health disorders: a randomized clinical trial.,"Objectives This study aimed to investigate whether inpatient multimodal occupational rehabilitation (I-MORE) reduces sickness absence (SA) more than outpatient acceptance and commitment therapy (O-ACT) among individuals with musculoskeletal and mental health disorders. Methods Individuals on sick leave (2-12 months) due to musculoskeletal or common mental health disorders were randomized to I-MORE (N=86) or O-ACT (N=80). I-MORE lasted 3.5 weeks in which participants stayed at the rehabilitation center. I-MORE included ACT, physical exercise, work-related problem solving and creating a return to work plan. O-ACT consisted mainly of 6 weekly 2.5 hour group-ACT sessions. We assessed the primary outcome cumulative SA within 6 and 12 months with national registry-data. Secondary outcomes were time to sustainable return to work and self-reported health outcomes assessed by questionnaires. Results SA did not differ between the interventions at 6 months, but after one year individuals in I-MORE had 32 fewer SA days compared to O-ACT (median 85 [interquartile range 33-149] versus 117 [interquartile range 59-189)], P=0.034). The hazard ratio for sustainable return to work was 1.9 (95% confidence interval 1.2-3.0) in favor of I-MORE. There were no clinically meaningful between-group differences in self-reported health outcomes. Conclusions Among individuals on long-term SA due to musculoskeletal and common mental health disorders, a 3.5-week I-MORE program reduced SA compared with 6 weekly sessions of O-ACT in the year after inclusion. Studies with longer follow-up and economic evaluations should be performed.",2020,"Results SA did not differ between the interventions at 6 months, but after one year individuals in I-MORE had 32 fewer SA days compared to O-ACT (median 85 [interquartile range 33-149] versus 117 [interquartile range 59-189)], P=0.034).","['individuals on long-term SA due to musculoskeletal and common mental health disorders', 'individuals with musculoskeletal and mental health disorders', 'Methods Individuals on sick leave (2-12 months) due to musculoskeletal or common mental health disorders', 'individuals with musculoskeletal and common mental health disorders']","['inpatient multimodal occupational rehabilitation (I-MORE', 'outpatient acceptance and commitment therapy (O-ACT', 'Inpatient multimodal occupational rehabilitation']","['sickness absence (SA', 'hazard ratio for sustainable return to work', 'time to sustainable return to work and self-reported health outcomes assessed by questionnaires']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0205214', 'cui_str': 'Common (qualifier value)'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder (disorder)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0242807', 'cui_str': 'Sick Leave'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C0521127', 'cui_str': 'Occupational (qualifier value)'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C3658321', 'cui_str': 'Acceptance and Commitment Therapy'}]","[{'cui': 'C0221423', 'cui_str': 'Illness (finding)'}, {'cui': 'C1689985', 'cui_str': 'Absence'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0425105', 'cui_str': 'Back to Work'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",,0.193806,"Results SA did not differ between the interventions at 6 months, but after one year individuals in I-MORE had 32 fewer SA days compared to O-ACT (median 85 [interquartile range 33-149] versus 117 [interquartile range 59-189)], P=0.034).","[{'ForeName': 'Sigmund Ø', 'Initials': 'SØ', 'LastName': 'Gismervik', 'Affiliation': 'Department of Public Health and Nursing, Faculty of Medicine and Health Sciences, Norwegian University of Science and Technology (NTNU), P.B. 8905 MTFS, 7491 Trondheim, Norway. sigmund.gismervik@ntnu.no.'}, {'ForeName': 'Lene', 'Initials': 'L', 'LastName': 'Aasdahl', 'Affiliation': ''}, {'ForeName': 'Ottar', 'Initials': 'O', 'LastName': 'Vasseljen', 'Affiliation': ''}, {'ForeName': 'Egil A', 'Initials': 'EA', 'LastName': 'Fors', 'Affiliation': ''}, {'ForeName': 'Marit B', 'Initials': 'MB', 'LastName': 'Rise', 'Affiliation': ''}, {'ForeName': 'Roar', 'Initials': 'R', 'LastName': 'Johnsen', 'Affiliation': ''}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Hara', 'Affiliation': ''}, {'ForeName': 'Henrik B', 'Initials': 'HB', 'LastName': 'Jacobsen', 'Affiliation': ''}, {'ForeName': 'Kristine', 'Initials': 'K', 'LastName': 'Pape', 'Affiliation': ''}, {'ForeName': 'Nils', 'Initials': 'N', 'LastName': 'Fleten', 'Affiliation': ''}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Jensen', 'Affiliation': ''}, {'ForeName': 'Marius S', 'Initials': 'MS', 'LastName': 'Fimland', 'Affiliation': ''}]","Scandinavian journal of work, environment & health",['10.5271/sjweh.3882'] 885,31837722,Effects of a universal prevention program on externalizing behaviors: Exploring the generalizability of findings across school and home settings.,"Universal prevention approaches have significantly reduced children's conduct problems and aggressive behavior in the school setting, but it has not been clear whether the effects generalize into children's behavior in home and community settings in later elementary school years. The present study examined this issue using a classroom-randomized design, with 1030 students in 70 fourth and fifth grade Italian classes. The intervention model is the Coping Power Universal and the classroom teachers delivered it. Coping Power Universal produced a significant reduction in both parents' and teachers' rated conduct problems, relative to control classes, indicating that universal prevention can produce significant reductions in children's conduct problems that generalize into the home and community settings. The intervention also increased children's prosocial behaviors in school and home settings. The Coping Power Universal is a short intervention model that is believed to be a useful strategy for children's behavioral problems in the broad population.",2019,"Coping Power Universal produced a significant reduction in both parents' and teachers' rated conduct problems, relative to control classes, indicating that universal prevention can produce significant reductions in children's conduct problems that generalize into the home and community settings.",['1030 students in 70 fourth and fifth grade Italian classes'],['universal prevention program'],"['externalizing behaviors', ""children's prosocial behaviors""]","[{'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0205438', 'cui_str': 'Fourth (qualifier value)'}, {'cui': 'C0205439', 'cui_str': 'Fifth (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0337810', 'cui_str': 'Italians (ethnic group)'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}]","[{'cui': 'C0175671', 'cui_str': 'Universal (qualifier value)'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0008059', 'cui_str': 'Child'}]",70.0,0.0424948,"Coping Power Universal produced a significant reduction in both parents' and teachers' rated conduct problems, relative to control classes, indicating that universal prevention can produce significant reductions in children's conduct problems that generalize into the home and community settings.","[{'ForeName': 'Pietro', 'Initials': 'P', 'LastName': 'Muratori', 'Affiliation': 'IRCCS Stella Maris, Scientific Institute of Child Neurology and Psychiatry, Pisa, Italy. Electronic address: pietro.muratori@fsm.unipi.it.'}, {'ForeName': 'Iacopo', 'Initials': 'I', 'LastName': 'Bertacchi', 'Affiliation': 'IRCCS Stella Maris, Scientific Institute of Child Neurology and Psychiatry, Associazione Mente Cognitiva, Lucca, Italy.'}, {'ForeName': 'Gabriele', 'Initials': 'G', 'LastName': 'Masi', 'Affiliation': 'IRCCS Stella Maris, Scientific Institute of Child Neurology and Psychiatry, Pisa, Italy.'}, {'ForeName': 'Annarita', 'Initials': 'A', 'LastName': 'Milone', 'Affiliation': 'IRCCS Stella Maris, Scientific Institute of Child Neurology and Psychiatry, Pisa, Italy.'}, {'ForeName': 'Annalaura', 'Initials': 'A', 'LastName': 'Nocentini', 'Affiliation': 'Department of Sciences of Education and Psychology, University of Florence, Firenze, Italy.'}, {'ForeName': 'Nicole P', 'Initials': 'NP', 'LastName': 'Powell', 'Affiliation': 'The University of Alabama, Tuscaloosa, USA.'}, {'ForeName': 'John E', 'Initials': 'JE', 'LastName': 'Lochman', 'Affiliation': 'The University of Alabama, Tuscaloosa, USA.'}, {'ForeName': 'Shannon', 'Initials': 'S', 'LastName': 'Jones', 'Affiliation': 'The University of Alabama, Tuscaloosa, USA.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Kassing', 'Affiliation': 'The University of Alabama, Tuscaloosa, USA.'}, {'ForeName': 'Devon', 'Initials': 'D', 'LastName': 'Romero', 'Affiliation': 'The University of Texas at San Antonio, USA.'}]",Journal of school psychology,['10.1016/j.jsp.2019.09.002'] 886,31852485,Intramedullary nailing for pertrochanteric fractures of proximal femur: a consecutive series of 323 patients treated with two devices.,"INTRODUCTION Pertrochanteric fractures (PFs) frequently affect the lower limb of osteoporotic patients and represent an important cause of morbidity and mortality in the elderly. In this prospective randomized controlled trial, we have compared functional and radiological results and complications of patients affected by PFs treated with two intramedullary proximal femoral nails. MATERIALS We enrolled 323 subjects with PFs, classified according to AO/OTA system as 31.A1 (pertrochanteric simple) and 31.A2 (pertrochanteric multifragmentary). Patients were divided into two groups according to the osteosynthesis devices: group A, Elos-Intrauma® nail (155 cases) and group B, Gamma 3-Stryker® nail (168 cases). Pre-operatively, the baseline characteristics of each patient (gender, age, weight and BMI) were collected. Intraoperative blood loss, subjective pain by visual analogue scale (VAS), esthetic satisfaction, functional scores of the hip by Harris Hip Score (HHS), and Western Ontario and McMaster Universities Arthritis Index (WOMAC) were noted. The post-operative degree of fracture reduction was assessed. Each patient had a minimum follow-up of 12 months. RESULTS The study group was composed of 106 male and 217 female with an average age of 85.4 (range, 65-90, standard deviation (SD) 5.95) years. No statistical differences about sex and age distribution were noted between the two groups. Group A reported lower intraoperative blood loss, 45 ml vs 51 ml, respectively (p < 0.001). There was not any statistical difference about operative time. Group A had a better reduction of fracture (p = 0.0347). The greatest difference was detectable comparing subgroups 31.A2 (p = 0.032). There were no statistical differences about complication frequency and the overall rate was 25% (80 cases). Finally, there was no difference in terms of VAS, HHS, and WOMAC score between the two groups on each follow-up. Patients of group A showed a higher subjective satisfaction index at 1 post-operative year, 7.42 (SD 1.19) vs 6.45 (SD 1.35) of group B (p < 0.001). CONCLUSION Elos® nail is a reliable device on a short-term follow-up and represents an alternative choice to the Gamma 3® nail, a well-known and appreciated system for over 25 years.",2019,"Group A reported lower intraoperative blood loss, 45 ml vs 51 ml, respectively (p < 0.001).","['patients affected by PFs treated with two intramedullary proximal femoral nails', '323 subjects with PFs, classified according to AO/OTA system as 31.A1 (pertrochanteric simple) and 31.A2 (pertrochanteric multifragmentary', '323 patients treated with two devices', 'pertrochanteric fractures of proximal femur', '106\u2009male and 217 female with an average age of 85.4 (range, 65-90, standard deviation (SD) 5.95) years']","['Intramedullary nailing', 'Elos-Intrauma® nail (155 cases) and group B, Gamma 3-Stryker® nail', 'Elos® nail']","['intraoperative blood loss', 'VAS, HHS, and WOMAC score', 'fracture reduction', 'subjective satisfaction index', 'Intraoperative blood loss, subjective pain by visual analogue scale (VAS), esthetic satisfaction, functional scores of the hip by Harris Hip Score (HHS), and Western Ontario and McMaster Universities Arthritis Index (WOMAC', 'overall rate', 'reduction of fracture']","[{'cui': 'C0522476', 'cui_str': 'Patient affected (contextual qualifier) (qualifier value)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C2732619', 'cui_str': 'Intramedullary'}, {'cui': 'C0205107', 'cui_str': 'Proximal (qualifier value)'}, {'cui': 'C0015811', 'cui_str': 'Femur'}, {'cui': 'C0027342', 'cui_str': 'Nails'}, {'cui': 'C0008902', 'cui_str': 'Systematics'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0205352', 'cui_str': 'Simple (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0281883', 'cui_str': 'Pertrochanteric fracture (disorder)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C4517646', 'cui_str': '217'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0021885', 'cui_str': 'Intramedullary Nailing'}, {'cui': 'C0027342', 'cui_str': 'Nails'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0441836', 'cui_str': 'Group B (qualifier value)'}, {'cui': 'C1552644', 'cui_str': 'Greek letter gamma'}]","[{'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1112432', 'cui_str': 'Reduction of fracture'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0014901', 'cui_str': 'Esthetics'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C2919875', 'cui_str': 'Harris hip score (observable entity)'}, {'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C3666006', 'cui_str': 'Arthritis (SMQ)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",323.0,0.0346224,"Group A reported lower intraoperative blood loss, 45 ml vs 51 ml, respectively (p < 0.001).","[{'ForeName': 'Pompeo', 'Initials': 'P', 'LastName': 'Catania', 'Affiliation': 'Department of Orthopaedics and Traumatology, San Giovanni-Addolorata Hospital, Rome, Italy.'}, {'ForeName': 'Daniele', 'Initials': 'D', 'LastName': 'Passaretti', 'Affiliation': 'Department of Orthopaedics and Traumatology, C.T.O. Hospital, Rome, Italy. passaretti.md@gmail.com.'}, {'ForeName': 'Giorgio', 'Initials': 'G', 'LastName': 'Montemurro', 'Affiliation': 'Department of Orthopaedics and Traumatology, San Giovanni-Addolorata Hospital, Rome, Italy.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Ripanti', 'Affiliation': 'Department of Orthopaedics and Traumatology, San Giovanni-Addolorata Hospital, Rome, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Carbone', 'Affiliation': 'Department of Orthopaedics and Traumatology, Clinica San Feliciano, Rome, Italy.'}, {'ForeName': 'Vittorio', 'Initials': 'V', 'LastName': 'Candela', 'Affiliation': 'Department of Orthopaedics and Traumatology, Sapienza University of Rome, ICOT, Latina, Italy.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Carnovale', 'Affiliation': 'Department of Orthopaedics and Traumatology, Sapienza University of Rome, ICOT, Latina, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Gumina', 'Affiliation': 'Department of Orthopaedics and Traumatology, Sapienza University of Rome, ICOT, Latina, Italy.'}, {'ForeName': 'Francecsco', 'Initials': 'F', 'LastName': 'Pallotta', 'Affiliation': 'Department of Orthopaedics and Traumatology, San Giovanni-Addolorata Hospital, Rome, Italy.'}]",Journal of orthopaedic surgery and research,['10.1186/s13018-019-1506-1'] 887,31884409,Prevention of leakage due to mouth opening through applying an oral shield device (Sominpax™) during nasal CPAP therapy of patients with obstructive sleep apnea.,"BACKGROUND/OBJECTIVE The first line treatment for obstructive sleep apnea (OSA) is nasal continuous positive airway pressure (nCPAP), for which a variety of masks are available. While nasal masks (NM) are the first choice; oronasal masks (ONM) are also frequently used to prevent mouth dryness resulting from mouth opening. Our cross-sectional, prospective, randomized, un-blinded study addressed the efficacy of wearing an oral shield in addition to NM in preventing mouth leakage METHODS: Patients with OSA and established therapy using NM and complaining about mouth dryness (n = 29) underwent three polysomnographies (PSGs) using NM, ONM or a nose mask in combination with an oral shield (NMS). Mask leakage was continuously documented and objective sleep quality was assessed. RESULTS There were significant differences in the apnea-hypopnea-index (AHI) between ONM (8.5/h; SD 6,7) and NM/nasal mask combined with oral shield device (NMS) (2.6/h; SD 2,3; 2.7/h; SD 2,6) (p < 0,05) as well as in leakage [ONM (39.7 l/min SD 12,4); NM (34.6 l/min SD 9,4); NMS (33.1 l/min SD 9,6)] (p = 0.011). Furthermore, analysis of sleep quality (NREM3) favored NM and NMS over ONM (p = 0.02). There were no significant differences between NM and NMS in any objective outcome. CONCLUSIONS Our data consistently confirmed the NM as the first choice for continuous positive airway pressure (CPAP) therapy of OSA. Notably, we demonstrated a high potential of the oral shield for patients with mouth opening to achieve additional comfort and thereby possibly compliance, without affecting nCPAP therapy effectiveness.",2020,"Furthermore, analysis of sleep quality (NREM3) favored NM and NMS over ONM (p = 0.02).","[' Patients with OSA and established therapy using NM and complaining about mouth dryness (n\xa0=\xa029) underwent', 'patients with obstructive sleep apnea', 'obstructive sleep apnea (OSA']","['three polysomnographies (PSGs) using NM, ONM or a nose mask in combination with an oral shield (NMS', 'oral shield device (Sominpax™) during nasal CPAP therapy']","['Mask leakage', 'apnea-hypopnea-index (AHI', 'objective sleep quality', 'leakage [ONM']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0443211', 'cui_str': 'Established (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0043352', 'cui_str': 'Mouth Dryness'}, {'cui': 'C0520679', 'cui_str': 'Syndrome, Sleep Apnea, Obstructive'}]","[{'cui': 'C0162701', 'cui_str': 'Monitoring, Sleep'}, {'cui': 'C0028429', 'cui_str': 'Nose'}, {'cui': 'C0024861', 'cui_str': 'Masks'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0183251', 'cui_str': 'Shield, device (physical object)'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C3665969', 'cui_str': 'Nasal CPAP'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0024861', 'cui_str': 'Masks'}, {'cui': 'C0015376', 'cui_str': 'Extravasation (morphologic abnormality)'}, {'cui': 'C2111846', 'cui_str': 'Apnea-hypopnea index'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}]",,0.0407408,"Furthermore, analysis of sleep quality (NREM3) favored NM and NMS over ONM (p = 0.02).","[{'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Foellner', 'Affiliation': 'Otto - von - Guericke University Magdeburg, Dept. of Pneumonology, Centre for Sleep Medicine, Magdeburg, Germany. Electronic address: sebastian.foellner@med.ovgu.de.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Guth', 'Affiliation': 'Otto - von - Guericke University Magdeburg, Dept. of Pneumonology, Centre for Sleep Medicine, Magdeburg, Germany.'}, {'ForeName': 'Ilka', 'Initials': 'I', 'LastName': 'Jorde', 'Affiliation': 'Otto - von - Guericke University Magdeburg, Dept. of Pneumonology, Centre for Sleep Medicine, Magdeburg, Germany.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Lücke', 'Affiliation': 'Otto - von - Guericke University Magdeburg, Dept. of Pneumonology, Centre for Sleep Medicine, Magdeburg, Germany.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Ganzert', 'Affiliation': 'Otto - von - Guericke University Magdeburg, Dept. of Pneumonology, Centre for Sleep Medicine, Magdeburg, Germany.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Stegemann-Koniszewski', 'Affiliation': 'Otto - von - Guericke University Magdeburg, Dept. of Pneumonology, Centre for Sleep Medicine, Magdeburg, Germany.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Schreiber', 'Affiliation': 'Otto - von - Guericke University Magdeburg, Dept. of Pneumonology, Centre for Sleep Medicine, Magdeburg, Germany.'}]",Sleep medicine,['10.1016/j.sleep.2019.06.023'] 888,31828492,Food Purchasing Behavior of Food Insecure Cancer Patients Receiving Supplemental Food Vouchers.,"PURPOSE Food insecure cancer patients experience worse health outcomes and poorer quality of life than food secure patients. There has been little research in programs to alleviate food insecurity in cancer patients. The objective of this paper is to report on the food purchasing behaviors of cancer patients enrolled in a supplemental food voucher program. METHODS This paper utilized data from a three-arm randomized controlled trial investigating the impact of food interventions on alleviating food insecurity in cancer patients receiving chemotherapy and/or radiation therapy. In one arm, patients received a monthly $230 voucher with which to purchase food. Receipts were collected for items purchased with the voucher and were coded to analyze purchasing behaviors. RESULTS Thirty-three patients provided receipts for more than 11,000 individual items. Patients spent 50% of voucher funds on animal protein, fruits, and vegetables. Patients spent, on average, 77% of voucher funds on items categorized as ""healthy."" CONCLUSIONS Patients who received a food voucher purchased more fruits and vegetables than national averages would suggest. They also spent less on sweetened beverages than national samples. Patients who were born outside of the United States or who were limited English proficient purchased significantly more healthy foods than English-speaking and American-born study patients. Supplemental food vouchers for food insecure cancer patients resulted in the purchase of healthy food items.",2020,Patients who were born outside of the United States or who were limited English proficient purchased significantly more healthy foods than English-speaking and American-born study patients.,"['cancer patients enrolled in a supplemental food voucher program', 'Food Insecure Cancer Patients Receiving Supplemental Food Vouchers', 'food insecure cancer patients', 'cancer patients receiving chemotherapy and/or radiation therapy', 'Patients who were born outside of the United States or who were limited English proficient purchased significantly more healthy foods than English-speaking and American-born study patients', 'cancer patients']","['food interventions', 'Supplemental food vouchers']","['quality of life', 'purchase of healthy food items']","[{'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0034619', 'cui_str': 'radiation therapy'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0205101', 'cui_str': 'External (qualifier value)'}, {'cui': 'C3540738', 'cui_str': 'English [International Organization for Standardization 639-1 code en] language reference set (foundation metadata concept)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0016452', 'cui_str': 'Food'}]","[{'cui': 'C0034380'}, {'cui': 'C0016452', 'cui_str': 'Food'}]",33.0,0.0469702,Patients who were born outside of the United States or who were limited English proficient purchased significantly more healthy foods than English-speaking and American-born study patients.,"[{'ForeName': 'Luke', 'Initials': 'L', 'LastName': 'Paolantonio', 'Affiliation': 'Immigrant Health and Cancer Disparities Service, Department of Psychiatry and Behavioral Sciences, Memorial Sloan Kettering Cancer Center, 485 Lexington Avenue, 2nd Floor, New York, NY, 10017, USA.'}, {'ForeName': 'Soo Young', 'Initials': 'SY', 'LastName': 'Kim', 'Affiliation': 'Immigrant Health and Cancer Disparities Service, Department of Psychiatry and Behavioral Sciences, Memorial Sloan Kettering Cancer Center, 485 Lexington Avenue, 2nd Floor, New York, NY, 10017, USA.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Ramirez', 'Affiliation': 'Immigrant Health and Cancer Disparities Service, Department of Psychiatry and Behavioral Sciences, Memorial Sloan Kettering Cancer Center, 485 Lexington Avenue, 2nd Floor, New York, NY, 10017, USA.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Roberts-Eversley', 'Affiliation': 'Immigrant Health and Cancer Disparities Service, Department of Psychiatry and Behavioral Sciences, Memorial Sloan Kettering Cancer Center, 485 Lexington Avenue, 2nd Floor, New York, NY, 10017, USA.'}, {'ForeName': 'Yuelin', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Immigrant Health and Cancer Disparities Service, Department of Psychiatry and Behavioral Sciences, Memorial Sloan Kettering Cancer Center, 485 Lexington Avenue, 2nd Floor, New York, NY, 10017, USA.'}, {'ForeName': 'Irina', 'Initials': 'I', 'LastName': 'Melnic', 'Affiliation': 'Immigrant Health and Cancer Disparities Service, Department of Psychiatry and Behavioral Sciences, Memorial Sloan Kettering Cancer Center, 485 Lexington Avenue, 2nd Floor, New York, NY, 10017, USA.'}, {'ForeName': 'Minlun', 'Initials': 'M', 'LastName': 'Wu', 'Affiliation': 'Immigrant Health and Cancer Disparities Service, Department of Psychiatry and Behavioral Sciences, Memorial Sloan Kettering Cancer Center, 485 Lexington Avenue, 2nd Floor, New York, NY, 10017, USA.'}, {'ForeName': 'Devika R', 'Initials': 'DR', 'LastName': 'Jutagir', 'Affiliation': 'Immigrant Health and Cancer Disparities Service, Department of Psychiatry and Behavioral Sciences, Memorial Sloan Kettering Cancer Center, 485 Lexington Avenue, 2nd Floor, New York, NY, 10017, USA.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Smith', 'Affiliation': 'Immigrant Health and Cancer Disparities Service, Department of Psychiatry and Behavioral Sciences, Memorial Sloan Kettering Cancer Center, 485 Lexington Avenue, 2nd Floor, New York, NY, 10017, USA.'}, {'ForeName': 'Modupe', 'Initials': 'M', 'LastName': 'Oladele', 'Affiliation': 'Immigrant Health and Cancer Disparities Service, Department of Psychiatry and Behavioral Sciences, Memorial Sloan Kettering Cancer Center, 485 Lexington Avenue, 2nd Floor, New York, NY, 10017, USA.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Gany', 'Affiliation': 'Immigrant Health and Cancer Disparities Service, Department of Psychiatry and Behavioral Sciences, Department of Medicine, and Department of Public Health, Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York, NY, USA. ganyf@mskcc.org.'}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-019-05183-4'] 889,30394065,Closed loop administration of propofol based on a Smith predictor: a randomized controlled trial.,"BACKGROUND Delay in the propofol pharmacodynamics effect is commonly observed in total intravenous anesthesia (TIVA). To face the delay in the hypnosis control, we have proposed a proportional-integral (PI) controller with a Smith predictor (PI+Smith). We have evaluated the feasibility of this closed-loop control for propofol administration and compared the performance with manual administration guided by the Bispectral Index (BIS). METHODS Fifty-seven adult patients under TIVA with propofol and remifentanil were randomly assigned to a PI+Smith or a manual control (MC) group. The BIS target was set to 50. The performance was compared through the global score (GS), median performance error (MDPE), median absolute performance error (MDAPE), offset and Wobble. RESULTS A total of 29 patients in the MC and 25 in the PI+Smith groups completed this study. Performance was significantly better in the PI+Smith group: global score was 25 (19 to 37) for PI+Smith versus 44 (32 to 57) for MC (P<0.001); MDPE was -0.9 (-5.6 to 2) for PI+Smith versus -11 (-16 to -4.3) for MC (P<0.001); MDAPE was 10.8 (8.8 to 14.3) for PI+Smith versus 17 (12.8 to 19.2) for MC (P<0.001); offset was -0.6 (-3.2 to 0.06) for PI+Smith versus -3.7 (-7.0 to -0.8) for MC (P=0.01). The percentage time of BIS within the 40-60 range during the maintenance phase was higher in the PI+Smith group 80.8 (68.7 to 87.9) than in the MC group 59.1 (53.4 to 72.5) (P<0.001). CONCLUSIONS The use of a specific mechanism in the PI controller to deal with the delay outperformed satisfactorily manual practice. The controller was able to regulate propofol administration, maintaining the BIS value within a desirable range and coping with oscillations.",2019,Performance was significantly better in the PI+Smith group: global score was 25 (19 to 37) for PI+Smith versus 44 (32 to 57) for MC (P<0.001); MDPE was -0.9 (-5.6 to 2) for PI+Smith versus -11,"['Fifty-seven adult patients under TIVA with', '29 patients in the MC and 25 in the PI+Smith groups completed this study']","['propofol and remifentanil', 'PI+Smith or a manual control (MC', 'propofol']","['global score (GS), median performance error (MDPE), median absolute performance error (MDAPE), offset and Wobble', 'percentage time of BIS', 'Bispectral Index (BIS', 'Performance', 'global score']","[{'cui': 'C4517815', 'cui_str': '57'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3854651', 'cui_str': 'TIVA'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C0175674', 'cui_str': 'Manual (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1872096', 'cui_str': 'bis(phenylacetylarginine)'}, {'cui': 'C1301882', 'cui_str': 'Bispectral index'}]",57.0,0.066883,Performance was significantly better in the PI+Smith group: global score was 25 (19 to 37) for PI+Smith versus 44 (32 to 57) for MC (P<0.001); MDPE was -0.9 (-5.6 to 2) for PI+Smith versus -11,"[{'ForeName': 'José A', 'Initials': 'JA', 'LastName': 'Reboso', 'Affiliation': 'Hospital Universitario de Canarias, San Cristóbal de La Laguna, Tenerife, Spain - jreboso@gmail.com.'}, {'ForeName': 'José M', 'Initials': 'JM', 'LastName': 'Gonzalez-Cava', 'Affiliation': 'Department of Computer Science and System Engineering, Universidad de La Laguna (ULL), San Cristóbal de La Laguna, Tenerife, Spain.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'León', 'Affiliation': 'Hospital Universitario de Canarias, San Cristóbal de La Laguna, Tenerife, Spain.'}, {'ForeName': 'Juan A', 'Initials': 'JA', 'LastName': 'Mendez-Perez', 'Affiliation': 'Department of Computer Science and System Engineering, Universidad de La Laguna (ULL), San Cristóbal de La Laguna, Tenerife, Spain.'}]",Minerva anestesiologica,['10.23736/S0375-9393.18.13058-6'] 890,31812463,"A double-blind, randomized controlled trial to evaluate the safety and immunogenicity of an intranasally administered trivalent inactivated influenza vaccine with the adjuvant LTh(αK): A phase II study.","BACKGROUND Intranasal influenza vaccines may provide protective efficacy by inducing both systemic antibodies and local secretory IgA. Live attenuated intranasal vaccines are not feasible for high-risk groups. A previously constructed inactivated vaccine with adjuvant revealed an association with neurological events in some studies. In this phase II trial, we aimed to evaluate the safety and immunogenicity of an intranasal influenza vaccine with a novel adjuvant, heat-labile enterotoxin (LT)-derived from E. coli (LTh(αK)). METHODS This study is a multicenter, randomized controlled, double-blind, phase II trial of an intranasal influenza vaccine containing 22.5 μg of the hemagglutinin (HA) antigen of three influenza strains in combination with 2 different LTh(αK) adjuvant doses (group 1: 30 μg; group 2: 45 μg) in subjects 20-70 years old. The control vaccine was 22.5 μg of influenza HA antigen alone (group 3). The vaccine was intranasally administered on days 1 and 8. Serum anti-HA antibody and nasal secretory IgA were measured, and adverse events (AEs) were recorded prevaccination and 29 (±2) days postvaccination. RESULTS Of 354 participants randomized in the study, 340 received two vaccine doses. AEs were mostly mild, and there was no discontinuation related to the vaccine. Only a higher frequency of diarrhea after the first dose was noted among group 2 (11.5%) than among group 3 (2.8%), and there was no significant difference after the second dose. The three groups had comparable serum anti-HA antibody immunogenicity. However, the adjuvanted vaccines induced greater mucosal IgA antibody production than the control vaccine. In a subgroup analysis, group 1 participants achieved adequate immunogenicity among both 20- to 60- and 61- to 70-year-old participants. CONCLUSION The intranasal influenza vaccine adjuvanted with LTh(αK) is generally safe and could provide systemic and local antibody responses. Adjuvanted vaccines were significantly more immunogenic than the nonadjuvanted control vaccine in mucosal immunity. ClinicalTrials.gov Identifier: NCT03784885.",2020,The intranasal influenza vaccine adjuvanted with LTh(αK) is generally safe and could provide systemic and local antibody responses.,"['354 participants randomized in the study, 340 received two vaccine doses', '20- to 60- and 61- to 70-year-old participants', 'containing 22.5\xa0μg of the hemagglutinin (HA) antigen of three influenza strains in combination with 2 different LTh(αK) adjuvant doses (group 1: 30\xa0μg; group 2: 45\xa0μg) in subjects 20-70\xa0years old']","['intranasally administered trivalent inactivated influenza vaccine with the adjuvant LTh(αK', 'intranasal influenza vaccine', 'vaccine', 'intranasal influenza vaccine adjuvanted with LTh(αK', 'intranasal influenza vaccine with a novel adjuvant, heat-labile enterotoxin (LT)-derived from E. coli (LTh(αK']","['Serum anti-HA antibody and nasal secretory IgA', 'adequate immunogenicity', 'frequency of diarrhea', 'mucosal IgA antibody production', 'safety and immunogenicity', 'serum anti-HA antibody immunogenicity']","[{'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C4517730', 'cui_str': '340'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C4517649', 'cui_str': 'Twenty-two point five'}, {'cui': 'C0018909', 'cui_str': 'Hemagglutinin'}, {'cui': 'C0003320', 'cui_str': 'Antigens'}, {'cui': 'C0021400', 'cui_str': 'Influenza, Human'}, {'cui': 'C0080194', 'cui_str': 'Strains'}, {'cui': 'C0441861', 'cui_str': 'Group 1 (qualifier value)'}, {'cui': 'C0441865', 'cui_str': 'Group 2 (qualifier value)'}]","[{'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0021403', 'cui_str': 'Influenza Vaccines'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach (qualifier value)'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C0014372', 'cui_str': 'Enterotoxins'}, {'cui': 'C0014834', 'cui_str': 'Escherichia coli'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C4520890', 'cui_str': 'Nasal'}, {'cui': 'C0020838', 'cui_str': 'Secretory IgA'}, {'cui': 'C0205411', 'cui_str': 'Adequate (qualifier value)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0026724', 'cui_str': 'Mucosal Tissue'}, {'cui': 'C0020835', 'cui_str': 'Immunoglobulin A'}, {'cui': 'C0003261', 'cui_str': 'Antibody Response'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",354.0,0.224877,The intranasal influenza vaccine adjuvanted with LTh(αK) is generally safe and could provide systemic and local antibody responses.,"[{'ForeName': 'Sung-Ching', 'Initials': 'SC', 'LastName': 'Pan', 'Affiliation': 'Department of Internal Medicine, National Taiwan University Hospital, College of Medicine, National Taiwan University, Taipei, Taiwan.'}, {'ForeName': 'Wei-Ting', 'Initials': 'WT', 'LastName': 'Hsu', 'Affiliation': 'Department of Internal Medicine, National Taiwan University Hospital, College of Medicine, National Taiwan University, Taipei, Taiwan.'}, {'ForeName': 'Wen-Sen', 'Initials': 'WS', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, Wan Fang Medical Center, College of Medicine, Taipei Medical University, Taipei, Taiwan.'}, {'ForeName': 'Ning-Chi', 'Initials': 'NC', 'LastName': 'Wang', 'Affiliation': 'Department of Internal Medicine, Tri-Service General Hospital, National Defense Medical Center, Taipei, Taiwan.'}, {'ForeName': 'Tzeng-Ji', 'Initials': 'TJ', 'LastName': 'Chen', 'Affiliation': 'Department of Family Medicine, Taipei Veterans General Hospital, Taipei, Taiwan.'}, {'ForeName': 'Ming-Che', 'Initials': 'MC', 'LastName': 'Liu', 'Affiliation': 'Department of Urology, Taipei Medical University Hospital, Taipei, Taiwan.'}, {'ForeName': 'Hui-Chen', 'Initials': 'HC', 'LastName': 'Pai', 'Affiliation': 'Advagene Biopharma Co., Ltd., Taipei, Taiwan; Development Center for Biotechnology, New Taipei City, Taiwan.'}, {'ForeName': 'Yu-Shen', 'Initials': 'YS', 'LastName': 'Hsu', 'Affiliation': 'Advagene Biopharma Co., Ltd., Taipei, Taiwan; Development Center for Biotechnology, New Taipei City, Taiwan.'}, {'ForeName': 'Mingi', 'Initials': 'M', 'LastName': 'Chang', 'Affiliation': 'Advagene Biopharma Co., Ltd., Taipei, Taiwan; Development Center for Biotechnology, New Taipei City, Taiwan.'}, {'ForeName': 'Szu-Min', 'Initials': 'SM', 'LastName': 'Hsieh', 'Affiliation': 'Department of Internal Medicine, National Taiwan University Hospital, College of Medicine, National Taiwan University, Taipei, Taiwan. Electronic address: hsmaids@hotmail.com.'}]",Vaccine,['10.1016/j.vaccine.2019.11.047'] 891,31791380,Individualised behaviour change strategies for physical activity in multiple sclerosis (IPAC-MS): protocol for a randomised controlled trial.,"BACKGROUND Multiple sclerosis (MS) is a chronic, degenerative disease of the central nervous system. Because of the long-term and unpredictable nature of the disease, the burden of MS is significant from both a patient and societal perspective. Despite a recent influx of disease-modifying therapies to treat MS, many individuals continue to experience disability that negatively affects productivity and quality of life. Previous research indicates that physical activity has a positive impact on walking function in individuals with MS, in addition to the usual beneficial effects on overall health. However, most people with MS are not active enough to gain these benefits, and a lack of support to initiate and maintain physical activity has been identified as a major barrier. This study will evaluate the impact of a novel intervention involving individualised behaviour change strategies delivered by neurophysiotherapists on increasing physical activity levels in individuals with MS who are currently inactive. METHODS/DESIGN This single-blind, parallel-group, randomised controlled trial will be conducted in Saskatchewan, Canada. Eligible participants include individuals with MS who are ambulatory but identified as currently inactive by the self-reported Godin Leisure-Time Exercise Questionnaire (GLTEQ). The intervention will be delivered by neurophysiotherapists and includes individualised behaviour change strategies aimed at increasing physical activity over a 12-month period. The control group will receive usual care during the 12-month study period. The primary outcome is the change in physical activity level, as measured by the change in the GLTEQ score from baseline to 12 months. Secondary outcomes include the change in patient-reported outcome measures assessing MS-specific symptoms, confidence and quality of life. DISCUSSION Physical activity has been identified as a top research priority by the MS community. Findings from this novel study may result in new knowledge that could significantly impact the management and overall health of individuals with MS. TRIAL REGISTRATION ClinicalTrials.gov, NCT04027114. Registered on 10 July 2019.",2019,"Findings from this novel study may result in new knowledge that could significantly impact the management and overall health of individuals with MS. ","['individuals with MS who are currently inactive', 'multiple sclerosis (IPAC-MS', 'individuals with MS', 'Eligible participants include individuals with MS who are ambulatory but identified as currently inactive by the self-reported Godin Leisure-Time Exercise Questionnaire (GLTEQ']",[],"['walking function', 'physical activity levels', 'change in physical activity level, as measured by the change in the GLTEQ score', 'change in patient-reported outcome measures assessing MS-specific symptoms, confidence and quality of life']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0026769', 'cui_str': 'MS (Multiple Sclerosis)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439841', 'cui_str': 'Ambulatory'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0086542', 'cui_str': 'Leisure'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",[],"[{'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0851408', 'cui_str': 'Changes in physical activity'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0025320', 'cui_str': 'Change of Life, Female'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C4277735', 'cui_str': 'Patient Reported Outcome Measures'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0237529', 'cui_str': 'Self Confidence'}, {'cui': 'C0034380'}]",,0.08976,"Findings from this novel study may result in new knowledge that could significantly impact the management and overall health of individuals with MS. ","[{'ForeName': 'Farren L', 'Initials': 'FL', 'LastName': 'Goulding', 'Affiliation': 'College of Pharmacy and Nutrition, University of Saskatchewan, 104 Clinic Place, Saskatoon, SK, Canada.'}, {'ForeName': 'Charity D', 'Initials': 'CD', 'LastName': 'Evans', 'Affiliation': 'College of Pharmacy and Nutrition, University of Saskatchewan, 104 Clinic Place, Saskatoon, SK, Canada. charity.evans@usask.ca.'}, {'ForeName': 'Katherine B', 'Initials': 'KB', 'LastName': 'Knox', 'Affiliation': 'College of Medicine, University of Saskatchewan, 107 Wiggins Road, Saskatoon, SK, Canada.'}, {'ForeName': 'Hyun J', 'Initials': 'HJ', 'LastName': 'Lim', 'Affiliation': 'College of Medicine, University of Saskatchewan, 107 Wiggins Road, Saskatoon, SK, Canada.'}, {'ForeName': 'Michael C', 'Initials': 'MC', 'LastName': 'Levin', 'Affiliation': 'College of Medicine, University of Saskatchewan, 107 Wiggins Road, Saskatoon, SK, Canada.'}, {'ForeName': 'Sarah J', 'Initials': 'SJ', 'LastName': 'Donkers', 'Affiliation': 'College of Medicine, University of Saskatchewan, 107 Wiggins Road, Saskatoon, SK, Canada.'}]",Trials,['10.1186/s13063-019-3768-7'] 892,31788995,Maintenance of pegylated liposomal doxorubicin/carboplatin in patients with advanced ovarian cancer: randomized study of an Asian Gynecologic Oncology Group.,"OBJECTIVES An Asian Gynecologic Oncology Group phase III randomized trial was conducted to determine whether maintenance chemotherapy could improve progression-free survival (PFS) in stages III/IV ovarian cancer. METHODS Between 2007 and 2014, 45 newly-diagnosed ovarian cancer patients were enrolled after complete remission and randomized (1:1) to arm A (4-weekly carboplatin area under the curve 4 and pegylated liposomal doxorubicin [PLD] 30 mg/m², n=24) for 6 cycles or arm B (observation, n=21). The primary end-point was PFS. A post hoc translational study was conducted to deep sequence BRCA /homologous recombination deficiency (HRD) genes, because BRCA /HRD mutations ( BRCA /HRD m ) are known to be associated with better prognosis. RESULTS Enrollment was slow, accrual was closed when 7+ years had passed. With a median follow-up of 88.9 months, the median PFS was significantly better in arm A (55.5 months) than arm B (9.2 months) (hazard ratio [HR]=0.40; 95% confidence interval [CI]=0.19-0.87; p=0.020), yet the median overall survival was not significantly different in arm A (not reached) than arm B (95.1 months) (p=0.148). Overall grade 3/4 adverse events were more frequent in arm A than arm B (60.9% vs 0.0%) (p<0.001). Quality of life was generally not significantly different. Distribution of BRCA1/2m or BRCA /HRD m was not significantly biased between the two arms. Wild-type BRCA /non-HRD subgroup seemed to fare better with maintenance therapy (HR=0.35; 95% CI=0.11-1.18; p=0.091). CONCLUSIONS Despite limitations in small sample size, it suggests that maintenance carboplatin-PLD chemotherapy could improve PFS in advanced ovarian cancer.",2020,Overall grade 3/4 adverse events were more frequent in arm A than arm B (60.9% vs 0.0%) (p<0.001).,"['Between 2007 and 2014', 'mutations ', 'Asian Gynecologic Oncology Group', 'advanced ovarian cancer', 'stages III/IV ovarian cancer', '45 newly-diagnosed ovarian cancer patients', 'patients with advanced ovarian cancer']","['HRD', 'maintenance chemotherapy', 'BRCA1/2m or BRCA /HRD', 'carboplatin area under the curve 4 and pegylated liposomal doxorubicin [PLD', 'carboplatin-PLD chemotherapy', 'pegylated liposomal doxorubicin/carboplatin']","['median PFS', 'Quality of life', 'progression-free survival (PFS', 'Overall grade 3/4 adverse events', 'median overall survival']","[{'cui': 'C0026882', 'cui_str': 'Mutation'}, {'cui': 'C0078988', 'cui_str': 'Asians'}, {'cui': 'C0205480', 'cui_str': 'Gynecologic (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C1140680', 'cui_str': 'Ovary Cancer'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0481504', 'cui_str': 'Maintenance Chemotherapy'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0717726', 'cui_str': 'doxorubicin liposome'}, {'cui': 'C0044369', 'cui_str': 'Pyridinium, 1-dodecyl-4-formyl-3-hydroxy-5-(hydroxymethyl)-2-methyl-, chloride'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0442757', 'cui_str': '3/4'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",,0.340547,Overall grade 3/4 adverse events were more frequent in arm A than arm B (60.9% vs 0.0%) (p<0.001).,"[{'ForeName': 'Chyong Huey', 'Initials': 'CH', 'LastName': 'Lai', 'Affiliation': 'Department of Obstetrics and Gynecology, Chang Gung Memorial Hospital Linkou Branch, Taoyuan, Taiwan. sh46erry@ms6.hinet.net.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Vallikad', 'Affiliation': ""Department of Gynecologic Oncology, St. John's Medical College, Bangalore, India.""}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Lin', 'Affiliation': 'Department of Obstetrics and Gynecology, Kaohsiung Chang Gung Memorial Hospital and Chang Gung University College of Medicine, Kaohsiung, Taiwan.'}, {'ForeName': 'Lan Yan', 'Initials': 'LY', 'LastName': 'Yang', 'Affiliation': 'Gynecologic Cancer Research Center, Chang Gung Memorial Hospital, Taoyuan, Taiwan.'}, {'ForeName': 'Shih Ming', 'Initials': 'SM', 'LastName': 'Jung', 'Affiliation': 'Department of Pathology, Chang Gung Memorial Hospital, Linkou Branch, and Chang Gung University College of Medicine, Taoyuan, Taiwan.'}, {'ForeName': 'Hsueh Erh', 'Initials': 'HE', 'LastName': 'Liu', 'Affiliation': 'School of Nursing, College of Medicine, Chang Gung University, Taoyuan, Taiwan.'}, {'ForeName': 'Yu Che', 'Initials': 'YC', 'LastName': 'Ou', 'Affiliation': 'Department of Obstetrics and Gynecology, Chang Gung Memorial Hospital, Chiayi Branch, Chang Gung University College of Medicine, Chiayi, Taiwan.'}, {'ForeName': 'Hung Hsueh', 'Initials': 'HH', 'LastName': 'Chou', 'Affiliation': 'Department of Obstetrics and Gynecology, Chang Gung Memorial Hospital, Linkou Branch, and Chang Gung University College of Medicine, Taoyuan, Taiwan.'}, {'ForeName': 'Cheng Tao', 'Initials': 'CT', 'LastName': 'Lin', 'Affiliation': 'Department of Obstetrics and Gynecology, Chang Gung Memorial Hospital, Linkou Branch, and Chang Gung University College of Medicine, Taoyuan, Taiwan.'}, {'ForeName': 'Huei Jean', 'Initials': 'HJ', 'LastName': 'Huang', 'Affiliation': 'Department of Obstetrics and Gynecology, Chang Gung Memorial Hospital, Linkou Branch, and Chang Gung University College of Medicine, Taoyuan, Taiwan.'}, {'ForeName': 'Kuan Gen', 'Initials': 'KG', 'LastName': 'Huang', 'Affiliation': 'Department of Obstetrics and Gynecology, Chang Gung Memorial Hospital, Linkou Branch, and Chang Gung University College of Medicine, Taoyuan, Taiwan.'}, {'ForeName': 'Jiantai', 'Initials': 'J', 'LastName': 'Qiu', 'Affiliation': 'Department of Obstetrics and Gynecology, Chang Gung Memorial Hospital, Linkou Branch, and Chang Gung University College of Medicine, Taoyuan, Taiwan.'}, {'ForeName': 'Yao Ching', 'Initials': 'YC', 'LastName': 'Hung', 'Affiliation': 'Department of Obstetrics and Gynecology, China Medical University and China Medical University Hospital, Taichung, Taiwan.'}, {'ForeName': 'Tzu I', 'Initials': 'TI', 'LastName': 'Wu', 'Affiliation': 'Department of Obstetrics and Gynecology, Taipei Municipal Wanfang Hospital, Taipei, Taiwan.'}, {'ForeName': 'Wei Yang', 'Initials': 'WY', 'LastName': 'Chang', 'Affiliation': 'Clinical Trial Center, Chang Gung Memorial Hospital, Taoyuan, Taiwan.'}, {'ForeName': 'Kien Thiam', 'Initials': 'KT', 'LastName': 'Tan', 'Affiliation': 'ACT Genomics, Taipei, Taiwan.'}, {'ForeName': 'Chiao Yun', 'Initials': 'CY', 'LastName': 'Lin', 'Affiliation': 'Gynecologic Cancer Research Center, Chang Gung Memorial Hospital, Taoyuan, Taiwan.'}, {'ForeName': 'Angel', 'Initials': 'A', 'LastName': 'Chao', 'Affiliation': 'Gynecologic Cancer Research Center, Chang Gung Memorial Hospital, Taoyuan, Taiwan.'}, {'ForeName': 'Chee Jen', 'Initials': 'CJ', 'LastName': 'Chang', 'Affiliation': 'Data Management and Biostatistical Core, Asian Gynecologic Oncology Group, Taoyuan, Taiwan.'}]",Journal of gynecologic oncology,['10.3802/jgo.2020.31.e5'] 893,30481998,Out-of-hospital cardiac arrest at place of residence is associated with worse outcomes in patients admitted to intensive care. A post-hoc analysis of the targeted temperature management trial.,"BACKGROUND The majority of out-of-hospital cardiac arrests (OHCAs) occur at place of residence, which is associated with worse outcomes in unselected prehospital populations. Our aim was to investigate whether location of arrest was associated with outcome in a selected group of initial survivors admitted to intensive care. METHODS This is a post-hoc analysis of the Targeted Temperature Management After Cardiac Arrest (TTM) trial, a multicenter controlled trial, randomizing 950 OHCA patients to an intervention of 33 °C or 36 °C. The location of cardiac arrest was defined as place of residence versus public place or other. The outcome measures were mortality and neurological outcome, as defined by the Cerebral Performance Category Scale, at 180 days. RESULTS Approximately half of 938 included patients arrested at place of residence (53%). Location groups did not differ with respect to age (P=0.11) or witnessed arrests (P=0.48) but bystander CPR was less common (P=0.02) at place of residence. OHCA at place of residence was associated with higher 180-day mortality (55% vs. 38%, P<0.001) and worse neurological outcome (61% vs. 43%, P<0.001) compared with a public place or other. After adjusting for known confounders, OHCA at place of residence remained an independent predictor of mortality (P=0.007). CONCLUSIONS Half of all initial survivors after OHCA admitted to intensive care had an arrest at place of residence which was independently associated with poor outcomes. Actions to improve outcomes after OHCA at place of residence should be addressed in future trials.",2019,Location groups did not differ with respect to age (P=0.11) or witnessed arrests (P=0.48) but bystander CPR was less common (P=0.02) at place of residence.,"['patients admitted to intensive care', '950 OHCA patients to an intervention of 33 °C or 36 °C', 'selected group of initial survivors admitted to intensive care']",[],"['180-day mortality', 'bystander CPR', 'mortality and neurological outcome, as defined by the Cerebral Performance Category Scale', 'neurological outcome']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0085559'}, {'cui': 'C4708800', 'cui_str': '950'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}]",[],"[{'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0007203', 'cui_str': 'Cardio-Pulmonary Resuscitation'}, {'cui': 'C0205494', 'cui_str': 'Neurologic (qualifier value)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0222045'}]",950.0,0.140822,Location groups did not differ with respect to age (P=0.11) or witnessed arrests (P=0.48) but bystander CPR was less common (P=0.02) at place of residence.,"[{'ForeName': 'Cecilia', 'Initials': 'C', 'LastName': 'Andréll', 'Affiliation': 'Center for Cardiac Arrest, Department of Clinical Sciences Lund, Faculty of Medicine, Lund University, Lund, Sweden - cecilia.andrell@med.lu.se.'}, {'ForeName': 'Josef', 'Initials': 'J', 'LastName': 'Dankiewicz', 'Affiliation': 'Center for Cardiac Arrest, Department of Clinical Sciences Lund, Faculty of Medicine, Lund University, Lund, Sweden.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Hassager', 'Affiliation': 'Department of Intensive Care, Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Janneke', 'Initials': 'J', 'LastName': 'Horn', 'Affiliation': 'Department of Adult Critical Care, University Hospital of Wales, Cardiff, UK.'}, {'ForeName': 'Jesper', 'Initials': 'J', 'LastName': 'Kjærgaard', 'Affiliation': 'Department of Intensive Care, Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Matilde', 'Initials': 'M', 'LastName': 'Winther-Jensen', 'Affiliation': 'Department of Intensive Care, Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Matt P', 'Initials': 'MP', 'LastName': 'Wise', 'Affiliation': 'Department of Anesthesia and Intensive Care, Helsingborg Hospital, Helsingborg, Sweden.'}, {'ForeName': 'Niklas', 'Initials': 'N', 'LastName': 'Nielsen', 'Affiliation': 'Center for Cardiac Arrest, Department of Clinical Sciences Lund, Faculty of Medicine, Lund University, Lund, Sweden.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Stammet', 'Affiliation': ''}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Friberg', 'Affiliation': 'Center for Cardiac Arrest, Department of Clinical Sciences Lund, Faculty of Medicine, Lund University, Lund, Sweden.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Minerva anestesiologica,['10.23736/S0375-9393.18.12878-1'] 894,30481999,Hemadsorption during cardiopulmonary bypass reduces interleukin 8 and tumor necrosis factor α serum levels in cardiac surgery: a randomized controlled trial.,"BACKGROUND Surgical trauma and cardiopulmonary bypass (CPB) are associated with the liberation of pro-inflammatory cytokines. With hemadsorption (Cytosorb®) during CPB, pro-inflammatory cytokines may be reduced and the inflammatory response may be decreased. METHODS In this prospective, randomized single center study, serum cytokine levels of interleukin 8 (Il-8), interleukin 6 (Il-6) and tumor-necrosis-factor α (TNFα) were assessed in elective on-pump cardiac surgery patients with hemadsorption on CPB (study group [SG], N.=20) and without (control group [CG], N.=20). Cytokine levels were assessed prior to CPB, at the end of CPB, and 6 hours (h) and 24 h after the end of CPB, together with a hemodynamic assessment. Cardiac-Index (CI) was assessed with transcardiopulmonary thermodilution. RESULTS For Il-8, significantly lower serum levels were observed in the SG compared to the CG at the end of CPB (P=0.008). In the SG, TNFα levels were also below those in the CG at both the end of and 6h after CPB (P=0.034). After 24 hours, TNFα levels were at baseline in both groups. No significant differences were found for Il-6. The CI was significantly higher in the SG at the end of CPB (P=0.025). However, there was no difference between both groups 6 h after CPB. CONCLUSIONS This prospective study shows a significant reduction in pro-inflammatory cytokine levels of Il-8 and TNFα with hemadsorption in on-pump cardiac surgery whilst also demonstrating safety in its applications. However, the differences in cytokine levels and CI between patients treated with hemadsorption and those without were minor and of short duration.",2019,The CI was significantly higher in the SG at the end of CPB (P=0.025).,"['pump cardiac surgery patients with hemadsorption on CPB (study group [SG], N.=20) and without (control group [CG], N.=20', 'cardiac surgery']",['cardiopulmonary bypass (CPB'],"['Cardiac-Index (CI', 'cytokine levels and CI', 'serum cytokine levels of interleukin 8 (Il-8), interleukin 6 (Il-6) and tumor-necrosis-factor α (TNFα', 'TNFα levels', 'serum levels', 'Cytokine levels']","[{'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0524727', 'cui_str': 'Surgery, Cardiac'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0018899', 'cui_str': 'Hemadsorptions'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0007202', 'cui_str': 'Heart-Lung Bypass'}]","[{'cui': 'C0428776', 'cui_str': 'Cardiac index (observable entity)'}, {'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0041368', 'cui_str': 'Tumor Necrosis Factors'}]",,0.0710611,The CI was significantly higher in the SG at the end of CPB (P=0.025).,"[{'ForeName': 'Ingo', 'Initials': 'I', 'LastName': 'Garau', 'Affiliation': 'Department of Anesthesiology, Center of Anesthesiology and Intensive Care Medicine, University Hospital Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'März', 'Affiliation': 'Department of Anesthesiology, Rostock University Medical Center, University of Rostock, Rostock, Germany.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Sehner', 'Affiliation': 'Department of Medical Biometry and Epidemiology of the University Medical Center, Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Daniel A', 'Initials': 'DA', 'LastName': 'Reuter', 'Affiliation': 'Department of Anesthesiology, Rostock University Medical Center, University of Rostock, Rostock, Germany.'}, {'ForeName': 'Hermann', 'Initials': 'H', 'LastName': 'Reichenspurner', 'Affiliation': 'Department of Cardiothoracic Surgery, University Heart Center, Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Zöllner', 'Affiliation': 'Department of Anesthesiology, Center of Anesthesiology and Intensive Care Medicine, University Hospital Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Jens C', 'Initials': 'JC', 'LastName': 'Kubitz', 'Affiliation': 'Department of Anesthesiology, Center of Anesthesiology and Intensive Care Medicine, University Hospital Hamburg-Eppendorf, Hamburg, Germany - jkubitz@uke.de.'}]",Minerva anestesiologica,['10.23736/S0375-9393.18.12898-7'] 895,31145907,Transcranial direct current stimulation of posterior temporal cortex modulates electrophysiological correlates of auditory selective spatial attention in posterior parietal cortex.,"Speech perception in ""cocktail-party"" situations, in which a sound source of interest has to be extracted out of multiple irrelevant sounds, poses a remarkable challenge to the human auditory system. Studies on structural and electrophysiological correlates of auditory selective spatial attention revealed critical roles of the posterior temporal cortex and the N2 event-related potential (ERP) component in the underlying processes. Here, we explored effects of transcranial direct current stimulation (tDCS) to posterior temporal cortex on neurophysiological correlates of auditory selective spatial attention, with a specific focus on the N2. In a single-blind, sham-controlled crossover design with baseline and follow-up measurements, monopolar anodal and cathodal tDCS was applied for 16 min to the right posterior superior temporal cortex. Two age groups of human subjects, a younger (n = 20; age 18-30 yrs) and an older group (n = 19; age 66-77 yrs), completed an auditory free-field multiple-speakers localization task while ERPs were recorded. The ERP data showed an offline effect of anodal, but not cathodal, tDCS immediately after DC offset for targets contralateral, but not ipsilateral, to the hemisphere of tDCS, without differences between groups. This effect mainly consisted in a substantial increase of the N2 amplitude by 0.9 μV (SE 0.4 μV; d = 0.40) compared with sham tDCS. At the same point in time, cortical source localization revealed a reduction of activity in ipsilateral (right) posterior parietal cortex. Also, localization error was improved after anodal, but not cathodal, tDCS. Given that both the N2 and the posterior parietal cortex are involved in processes of auditory selective spatial attention, these results suggest that anodal tDCS specifically enhanced inhibitory attentional brain processes underlying the focusing onto a target sound source, possibly by improved suppression of irrelevant distracters.",2019,"At the same point in time, cortical source localization revealed a reduction of activity in ipsilateral (right) posterior parietal cortex.","['posterior parietal cortex', 'Two age groups of human subjects, a younger (n\u202f=\u202f20; age 18-30\u202fyrs) and an older group (n\u202f=\u202f19; age 66-77\u202fyrs), completed an auditory free-field multiple-speakers localization task while ERPs were recorded']","['monopolar anodal and cathodal tDCS', 'transcranial direct current stimulation (tDCS']","['activity in ipsilateral (right) posterior parietal cortex', 'localization error', 'inhibitory attentional brain processes']","[{'cui': 'C3853037', 'cui_str': 'Posterior Parietal Cortex'}, {'cui': 'C0027362', 'cui_str': 'Age Groups'}, {'cui': 'C0080105', 'cui_str': 'Human Subjects'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439825', 'cui_str': 'Auditory (qualifier value)'}, {'cui': 'C0440042', 'cui_str': ""Field's""}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0475264', 'cui_str': 'Localization - action (qualifier value)'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}]","[{'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0441989', 'cui_str': 'Ipsilateral (qualifier value)'}, {'cui': 'C3853037', 'cui_str': 'Posterior Parietal Cortex'}, {'cui': 'C0475264', 'cui_str': 'Localization - action (qualifier value)'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C4521054', 'cui_str': 'Process (qualifier value)'}]",,0.0286544,"At the same point in time, cortical source localization revealed a reduction of activity in ipsilateral (right) posterior parietal cortex.","[{'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Hanenberg', 'Affiliation': 'Ruhr University Bochum, Faculty of Psychology, D-44780, Bochum, Germany; Leibniz Research Centre for Working Environment and Human Factors, D-44139, Dortmund, Germany.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Getzmann', 'Affiliation': 'Leibniz Research Centre for Working Environment and Human Factors, D-44139, Dortmund, Germany.'}, {'ForeName': 'Jörg', 'Initials': 'J', 'LastName': 'Lewald', 'Affiliation': 'Ruhr University Bochum, Faculty of Psychology, D-44780, Bochum, Germany. Electronic address: Joerg.Lewald@rub.de.'}]",Neuropsychologia,['10.1016/j.neuropsychologia.2019.05.023'] 896,31539169,Acceptance and commitment therapy for breast cancer survivors with fear of cancer recurrence: A 3-arm pilot randomized controlled trial.,"BACKGROUND Fear of cancer recurrence (FCR) has a profound negative impact on quality of life (QOL) for many cancer survivors. Breast cancer survivors (BCS) are particularly vulnerable, with up to 70% reporting clinically significant FCR. To the authors' knowledge, evidence-based interventions for managing FCR are limited. Acceptance and commitment therapy (ACT) promotes psychological flexibility in managing life's stressors. The current study examined the feasibility and preliminary efficacy of group-based ACT for FCR in BCS. METHODS Post-treatment BCS (91 patients with stage I-III disease) with clinical FCR randomly were assigned to ACT (6 weekly 2-hour group sessions), survivorship education (SE; 6 weekly 2-hour group sessions), or enhanced usual care (EUC; one 30-minute group coaching session with survivorship readings). FCR severity (primary outcome) and avoidant coping, anxiety, post-traumatic stress, depression, QOL, and other FCR-related variables (secondary outcomes) were assessed at baseline (T1), after the intervention (T2), 1 month after the intervention (T3), and 6 months after the intervention (T4) using intent-to-treat analysis. RESULTS Satisfactory recruitment (43.8%) and retention (94.5%) rates demonstrated feasibility. Although each arm demonstrated within-group reductions in FCR severity over time, only ACT produced significant reductions at each time point compared with baseline, with between-group differences at T4 substantially favoring ACT over SE (Cohen d for effect sizes, 0.80; P < .001) and EUC (Cohen d, 0.61; P < .01). For 10 of 12 secondary outcomes, only ACT produced significant within-group reductions across all time points. By T4, significant moderate to large between-group comparisons favored ACT over SE and EUC with regard to avoidant coping, anxiety, depression, QOL, and FCR-related psychological distress. CONCLUSIONS Group-based ACT is a feasible and promising treatment for FCR and associated outcomes in BCS that warrants testing in larger, fully powered trials.",2020,"Although each arm demonstrated within-group reductions in FCR severity over time, only ACT produced significant reductions at each time point compared with baseline, with between-group differences at T4 substantially favoring ACT over SE (Cohen","['Post-treatment BCS (91 patients with stage I-III disease) with clinical FCR randomly', 'breast cancer survivors\xa0with fear of cancer recurrence', 'Breast cancer\xa0survivors (BCS']","['Acceptance and commitment therapy (ACT', 'survivorship education (SE; 6\xa0weekly 2-hour group sessions), or enhanced usual care (EUC; one\xa030-minute group coaching session with survivorship readings', 'ACT']","['quality of life (QOL', 'FCR severity', 'avoidant coping, anxiety, depression, QOL, and FCR-related psychological distress', 'FCR severity (primary outcome) and avoidant coping, anxiety, post-traumatic stress, depression, QOL, and other FCR-related variables (secondary outcomes']","[{'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1 (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0233705', 'cui_str': 'Fear of getting cancer (finding)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}]","[{'cui': 'C3658321', 'cui_str': 'Acceptance and Commitment Therapy'}, {'cui': 'C0038955'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C1292425', 'cui_str': '2 hours (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1442458', 'cui_str': 'Thirty minutes (qualifier value)'}]","[{'cui': 'C0034380'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0332663', 'cui_str': 'Traumatic (qualifier value)'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}]",91.0,0.11198,"Although each arm demonstrated within-group reductions in FCR severity over time, only ACT produced significant reductions at each time point compared with baseline, with between-group differences at T4 substantially favoring ACT over SE (Cohen","[{'ForeName': 'Shelley A', 'Initials': 'SA', 'LastName': 'Johns', 'Affiliation': 'Department of Medicine, Indiana University School of Medicine, Indianapolis, Indiana.'}, {'ForeName': 'Patrick V', 'Initials': 'PV', 'LastName': 'Stutz', 'Affiliation': 'Department of Medicine, Indiana University School of Medicine, Indianapolis, Indiana.'}, {'ForeName': 'Tasneem L', 'Initials': 'TL', 'LastName': 'Talib', 'Affiliation': 'Center for Health Services Research, Regenstrief Institute, Inc., Indianapolis, Indiana.'}, {'ForeName': 'Andrea A', 'Initials': 'AA', 'LastName': 'Cohee', 'Affiliation': 'Indiana University School of Nursing, Indianapolis, Indiana.'}, {'ForeName': 'Kathleen A', 'Initials': 'KA', 'LastName': 'Beck-Coon', 'Affiliation': 'Department of Medicine, Indiana University School of Medicine, Indianapolis, Indiana.'}, {'ForeName': 'Linda F', 'Initials': 'LF', 'LastName': 'Brown', 'Affiliation': 'Department of Medicine, Indiana University School of Medicine, Indianapolis, Indiana.'}, {'ForeName': 'Laura R', 'Initials': 'LR', 'LastName': 'Wilhelm', 'Affiliation': 'Department of Behavioral Medicine and Psychiatry, West Virginia University School of Medicine, Charleston, West Virginia.'}, {'ForeName': 'Patrick O', 'Initials': 'PO', 'LastName': 'Monahan', 'Affiliation': 'Department of Biostatistics, Indiana University School of Medicine, Indianapolis, Indiana.'}, {'ForeName': 'Michelle L', 'Initials': 'ML', 'LastName': 'LaPradd', 'Affiliation': 'Department of Medicine, Indiana University School of Medicine, Indianapolis, Indiana.'}, {'ForeName': 'Victoria L', 'Initials': 'VL', 'LastName': 'Champion', 'Affiliation': 'Indiana University School of Nursing, Indianapolis, Indiana.'}, {'ForeName': 'Kathy D', 'Initials': 'KD', 'LastName': 'Miller', 'Affiliation': 'Department of Medicine, Indiana University School of Medicine, Indianapolis, Indiana.'}, {'ForeName': 'R Brian', 'Initials': 'RB', 'LastName': 'Giesler', 'Affiliation': 'Department of Psychology, Butler University, Indianapolis, Indiana.'}]",Cancer,['10.1002/cncr.32518'] 897,31829767,Safety of the AS04-adjuvanted human papillomavirus (HPV)-16/18 vaccine in adolescents aged 12-15 years: end-of-study results from a community-randomized study up to 6.5 years.,"This manuscript discloses end-of-study safety data of a community-randomized controlled trial in Finland (NCT00534638), assessing the effectiveness of two vaccination strategies (gender-neutral versus females only) using the AS04-adjuvanted human papillomavirus (HPV)-16/18 (AS04-HPV-16/18) vaccine. The total vaccination cohort included 32,175 adolescents aged 12-15 y at vaccination of whom 14,837 received the AS04-HPV-16/18 vaccine and 17,338 received the hepatitis-B virus vaccine (control). Spontaneous reporting of serious adverse events (SAEs) combined with surveillance using nation-wide health registries showed an acceptable safety profile of the AS04-HPV-16/18 vaccine. During the study period (up to 6.5 y), the incidences (per 100,000 person-years) of reported SAEs considered as possibly related to vaccination were 39.1 (95% confidence interval [CI]: 25.3-57.7) and 39.8 (95%CI: 26.8-56.8) in the HPV and control groups, respectively. The most frequently reported new-onset autoimmune diseases (NOADs) were ulcerative colitis (incidence rates of 28.2 and 33.1 per 100,000 person-years in the HPV and control groups, respectively), insulin-dependent diabetes mellitus (21.9 and 37.1), Crohn's disease (15.6 and 22.5), celiac disease (15.6 and 21.2), and juvenile idiopathic arthritis (14.1 and 15.9). Of 1,344 pregnancies reported (777 and 567 in the HPV and control groups, respectively), most resulted in elective termination (58.4% and 58.6%), birth of a live infant (32.7% and 32.3%), or in spontaneous abortion (8.0% and 7.9%). No major, registered congenital anomalies were identified. The incidence rates of NOADs and pregnancy outcomes were generally balanced between groups. No specific safety signals were identified in the population-based health registry surveillance. Plain Language Summary What is the context? ● Since first licensure in 2007 of the AS04-adjuvanted human papillomavirus (HPV)-16/18 vaccine ( Cervarix , GSK), large quantity of safety data has been collected and confirmed its safety profile. This study provides further unique, population-based safety data from vaccinated Finnish adolescents monitored via health registries up to 6.5 y of follow-up. What is new? ● The vaccine has shown an acceptable safety profile in girls and boys. The risk of new-onset autoimmune diseases (NOADs) was similar between the HPV vaccine group and the control group and in line with the expectations for the studied population. ● The study supports that safety surveillance via national health registries is in general more sensitive than the conventional safety reporting, notably for monitoring specific chronic diseases, e.g. autoimmune disorders. What is the impact? ● This study highlights the importance of health registries in long-term vaccination safety surveillance. The population-based safety data reported in this study further support the routine administration of the HPV vaccine to girls and boys.",2020,The risk of new-onset autoimmune diseases (NOADs) was similar between the HPV vaccine group and the control group and in line with the expectations for the studied population.,"['vaccinated Finnish adolescents monitored via health registries up to 6.5 y of follow-up', ""of 28.2 and 33.1 per 100,000 person-years in the HPV and control groups, respectively), insulin-dependent diabetes mellitus (21.9 and 37.1), Crohn's disease (15.6 and 22.5), celiac disease (15.6 and 21.2), and juvenile idiopathic arthritis (14.1 and 15.9"", 'adolescents aged 12-15 years', '32,175 adolescents aged 12-15 y at vaccination of whom 14,837 received the', '1,344 pregnancies reported ', 'girls and boys']","['AS04-adjuvanted human papillomavirus (HPV)-16/18 (AS04-HPV-16/18) vaccine', 'AS04-HPV-16/18 vaccine', 'HPV vaccine', 'hepatitis-B virus vaccine (control', 'AS04-adjuvanted human papillomavirus (HPV)-16/18 vaccine']","['incidence rates of NOADs and pregnancy outcomes', 'birth of a live infant', 'elective termination', 'risk of new-onset autoimmune diseases (NOADs', 'spontaneous abortion', 'ulcerative colitis (incidence rates']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0181904', 'cui_str': 'Monitor, device (physical object)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C3844007', 'cui_str': '6.5'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0011854', 'cui_str': 'Diabetes Mellitus, Type 1'}, {'cui': 'C0156147', 'cui_str': 'Colitis, Granulomatous'}, {'cui': 'C4517649', 'cui_str': 'Twenty-two point five'}, {'cui': 'C0007570', 'cui_str': 'Sprue, Nontropical'}, {'cui': 'C3495559', 'cui_str': 'Arthritis, Juvenile Chronic'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0870221', 'cui_str': 'Boys'}]","[{'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C1512511', 'cui_str': 'HPV Vaccines'}, {'cui': 'C0062527', 'cui_str': 'Hepatitis B Surface Antigen Vaccine'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0032972', 'cui_str': 'Pregnancy Outcome'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0004364', 'cui_str': 'Autoimmune Diseases'}, {'cui': 'C0000786', 'cui_str': 'Vaginal expulsion of product of conception'}, {'cui': 'C0009324', 'cui_str': 'Inflammatory Bowel Disease, Ulcerative Colitis Type'}]",,0.240165,The risk of new-onset autoimmune diseases (NOADs) was similar between the HPV vaccine group and the control group and in line with the expectations for the studied population.,"[{'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Bi', 'Affiliation': 'GSK , Wavre, Belgium.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Apter', 'Affiliation': 'Sexual Health Clinic, Family Federation of Finland , Helsinki, Finland.'}, {'ForeName': 'Tiina', 'Initials': 'T', 'LastName': 'Eriksson', 'Affiliation': 'Faculty of Social Sciences, University of Tampere , Tampere, Finland.'}, {'ForeName': 'Mari', 'Initials': 'M', 'LastName': 'Hokkanen', 'Affiliation': 'Faculty of Social Sciences, University of Tampere , Tampere, Finland.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Zima', 'Affiliation': 'EMD Serono , Billerica, MA, USA.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Damaso', 'Affiliation': 'GSK , Wavre, Belgium.'}, {'ForeName': 'Maaria', 'Initials': 'M', 'LastName': 'Soila', 'Affiliation': 'GSK , Espoo, Finland.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Dubin', 'Affiliation': 'Takeda Pharmaceuticals , Zurich, Switzerland.'}, {'ForeName': 'Matti', 'Initials': 'M', 'LastName': 'Lehtinen', 'Affiliation': 'Faculty of Social Sciences, University of Tampere , Tampere, Finland.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Struyf', 'Affiliation': 'GSK , Wavre, Belgium.'}]",Human vaccines & immunotherapeutics,['10.1080/21645515.2019.1692557'] 898,31886828,Effect of Treating Parents Colonized With Staphylococcus aureus on Transmission to Neonates in the Intensive Care Unit: A Randomized Clinical Trial.,"Importance Staphylococcus aureus is a leading cause of health care-associated infections in the neonatal intensive care unit (NICU). Parents may expose neonates to S aureus colonization, a well-established predisposing factor to invasive S aureus disease. Objective To test whether treating parents with intranasal mupirocin and topical chlorhexidine compared with placebo would reduce transmission of S aureus from parents to neonates. Design, Setting, and Participants Double-blinded randomized clinical trial in 2 tertiary NICUs in Baltimore, Maryland. Neonates (n = 236) with S aureus-colonized parent(s) were enrolled. The study period was November 7, 2014, through December 13, 2018. Interventions Parents were assigned to intranasal mupirocin and 2% chlorhexidine-impregnated cloths (active treatment, n = 117) or petrolatum intranasal ointment and nonmedicated soap cloths (placebo, n = 119) for 5 days. Main Outcomes and Measures The primary end point was concordant S aureus colonization by 90 days, defined as neonatal acquisition of an S aureus strain that was the same strain as a parental strain at time of screening. Secondary outcomes included neonatal acquisition of any S aureus strain and neonatal S aureus infections. Results Among 236 randomized neonates, 208 were included in the analytic sample (55% male; 76% singleton births; mean birth weight, 1985 g [SD, 958 g]; 76% vaginal birth; mean parent age, 31 [SD, 7] years), of whom 18 were lost to follow-up. Among 190 neonates included in the analysis, 74 (38.9%) acquired S aureus colonization by 90 days, of which 42 (56.8%) had a strain concordant with a parental baseline strain. In the intervention and placebo groups, 13 of 89 neonates (14.6%) and 29 of 101 neonates (28.7%), respectively, acquired concordant S aureus colonization (risk difference, -14.1% [95% CI, -30.8% to -3.9%]; hazard ratio [HR], 0.43 [95.2% CI, 0.16 to 0.79]). A total of 28 of 89 neonates (31.4%) in the intervention group and 46 of 101 (45.5%) in the control group acquired any S aureus strain (HR, 0.57 [95% CI, 0.31 to 0.88]), and 1 neonate (1.1%) in the intervention group and 1 neonate (1.0%) in the control group developed an S aureus infection before colonization. Skin reactions in parents were common (4.8% intervention, 6.2% placebo). Conclusions and Relevance In this preliminary trial of parents colonized with S aureus, treatment with intranasal mupirocin and chlorhexidine-impregnated cloths compared with placebo significantly reduced neonatal colonization with an S aureus strain concordant with a parental baseline strain. However, further research is needed to replicate these findings and to assess their generalizability. Trial Registration ClinicalTrials.gov Identifier: NCT02223520.",2019,"To test whether treating parents with intranasal mupirocin and topical chlorhexidine compared with placebo would reduce transmission of S aureus from parents to neonates. ","['76% vaginal birth; mean parent age, 31 [SD, 7] years), of whom 18 were lost to follow-up', '190 neonates included in the analysis, 74 (38.9', 'Neonates (n\u2009=\u2009236) with S aureus-colonized parent(s) were enrolled', ' 208 were included in the analytic sample (55% male', 'Parents Colonized With Staphylococcus aureus on Transmission to Neonates in the Intensive Care Unit', '76% singleton births; mean birth weight, 1985 g [SD, 958 g', 'The study period was November 7, 2014, through December 13, 2018', '236 randomized neonates', 'parents to neonates']","['placebo', 'intranasal mupirocin and 2% chlorhexidine-impregnated cloths (active treatment, n\u2009=\u2009117) or petrolatum intranasal ointment and nonmedicated soap cloths (placebo, n\u2009=\u2009119) for 5 days', 'intranasal mupirocin and topical chlorhexidine', 'intranasal mupirocin and chlorhexidine-impregnated cloths']","['neonatal acquisition of any S aureus strain and neonatal S aureus infections', 'acquired S aureus colonization', 'neonatal acquisition of an S aureus strain', 'neonatal colonization', 'Skin reactions', 'transmission of S aureus', 'concordant S aureus colonization']","[{'cui': 'C4521343', 'cui_str': 'Vaginal (intended site)'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1302313', 'cui_str': 'Lost to Follow-Up'}, {'cui': 'C4517622', 'cui_str': 'One hundred and ninety'}, {'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0038172', 'cui_str': 'Staphylococcus aureus'}, {'cui': 'C0040722', 'cui_str': 'transmission'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0005612', 'cui_str': 'Birth Weight'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach (qualifier value)'}, {'cui': 'C0085259', 'cui_str': 'Mupirocin'}, {'cui': 'C0008196', 'cui_str': 'Chlorhexidine'}, {'cui': 'C0039717', 'cui_str': 'Textiles'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0031262', 'cui_str': 'Petrolatum'}, {'cui': 'C0028912', 'cui_str': 'Salves'}, {'cui': 'C0037392', 'cui_str': 'Soap'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}]","[{'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}, {'cui': 'C0080194', 'cui_str': 'Strains'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0439661', 'cui_str': 'Acquired (qualifier value)'}, {'cui': 'C0221743', 'cui_str': 'Skin reaction (observable entity)'}, {'cui': 'C0040722', 'cui_str': 'transmission'}]",236.0,0.562881,"To test whether treating parents with intranasal mupirocin and topical chlorhexidine compared with placebo would reduce transmission of S aureus from parents to neonates. ","[{'ForeName': 'Aaron M', 'Initials': 'AM', 'LastName': 'Milstone', 'Affiliation': 'Division of Infectious Diseases, Department of Pediatrics, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Annie', 'Initials': 'A', 'LastName': 'Voskertchian', 'Affiliation': 'Division of Infectious Diseases, Department of Pediatrics, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Danielle W', 'Initials': 'DW', 'LastName': 'Koontz', 'Affiliation': 'Division of Infectious Diseases, Department of Pediatrics, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Dina F', 'Initials': 'DF', 'LastName': 'Khamash', 'Affiliation': 'Division of Infectious Diseases, Department of Pediatrics, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Tracy', 'Initials': 'T', 'LastName': 'Ross', 'Affiliation': 'Division of Medical Microbiology, Department of Pathology, The Johns Hopkins Hospital, Baltimore, Maryland.'}, {'ForeName': 'Susan W', 'Initials': 'SW', 'LastName': 'Aucott', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Maureen M', 'Initials': 'MM', 'LastName': 'Gilmore', 'Affiliation': 'Division of Neonatology, Department of Pediatrics, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Sara E', 'Initials': 'SE', 'LastName': 'Cosgrove', 'Affiliation': 'Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.'}, {'ForeName': 'Karen C', 'Initials': 'KC', 'LastName': 'Carroll', 'Affiliation': 'Division of Medical Microbiology, Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Colantuoni', 'Affiliation': 'Department of Biostatistics, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.'}]",JAMA,['10.1001/jama.2019.20785'] 899,31791389,eHealth-supported case management for patients with panic disorder or depression in primary care: Study protocol for a cRCT (PREMA).,"BACKGROUND Panic disorder (PD), frequently occurring with agoraphobia (AG), and depression are common mental disorders in primary care and associated with considerable individual and societal costs. Early detection and effective treatment of depression and PD/AG are of major importance. Cognitive behavioural exposure exercises have been shown to be effective in reducing anxiety and depressive symptoms. Practice team-based case management can improve clinical outcomes for patients with chronic diseases in primary care. The present study aims at evaluating the effects and cost-effectiveness of a primary care team-based intervention using behavioural therapy elements and case management supported by eHealth components in patients with PD/AG or depression compared to treatment as usual. METHODS/DESIGN This is a two-arm cluster-randomized, controlled trial (cRCT). General practices represent the units of randomisation. General practitioners recruit adult patients with depression and PD ± AG according to the International Classification of Diseases, version 10 (ICD-10). In the intervention group, patients receive cognitive behaviour therapy-oriented psychoeducation and instructions to self-managed exposure exercises in four manual-based appointments with the general practitioner. A trained health care assistant from the practice team delivers case management and is continuously monitoring symptoms and treatment progress in ten protocol-based telephone contacts with patients. Practice teams and patients are supported by eHealth components. In the control group, patients receive usual care from general practitioners. Outcomes are measured at baseline (T0), at follow-up after 6 months (T1), and at follow-up after 12 months (T2). The primary outcome is the mental health status of patients as measured by the Mental Health Index (MHI-5). Effect sizes of 0.2 standard deviation (SD) are regarded as relevant. Assuming a drop-out rate of 20% of practices and patients each, we aim at recruiting 1844 patients in 148 primary care practices. This corresponds to 12.5 patients on average per primary care practice. Secondary outcomes include depression and anxiety-related clinical parameters and health-economic costs. DISCUSSION If the intervention is more effective than treatment as usual, the three-component (cognitive behaviour therapy, case-management, eHealth) primary care-based intervention for patients suffering from PD/AG or depression could be a valuable low-threshold option that benefits patients and primary care practice teams. TRIAL REGISTRATION German clinical trials register, DRKS00016622. Registered on February 22nd, 2019.",2019,"The present study aims at evaluating the effects and cost-effectiveness of a primary care team-based intervention using behavioural therapy elements and case management supported by eHealth components in patients with PD/AG or depression compared to treatment as usual. ","['General practitioners recruit adult patients with depression and PD\u2009±\u2009AG', 'patients with chronic diseases in primary care', 'patients with panic disorder or depression in primary care', '1844 patients in 148 primary care practices', '12.5 patients on average per primary care practice', 'patients with PD/AG or depression compared to treatment as usual']","['cognitive behaviour therapy-oriented psychoeducation and instructions to self-managed exposure exercises in four manual-based appointments with the general practitioner', 'Cognitive behavioural exposure exercises']","['mental health status of patients as measured by the Mental Health Index (MHI-5', 'anxiety and depressive symptoms', 'depression and anxiety-related clinical parameters and health-economic costs']","[{'cui': 'C0017319', 'cui_str': 'Physicians, General Practice'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0008679', 'cui_str': 'Chronic Illness'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0030319', 'cui_str': 'Panic Disorder'}, {'cui': 'C4517544', 'cui_str': '12.5 (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0871175', 'cui_str': 'Psycho-education'}, {'cui': 'C0039401', 'cui_str': 'Teaching'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0175674', 'cui_str': 'Manual (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0003629', 'cui_str': 'Appointments'}, {'cui': 'C0017319', 'cui_str': 'Physicians, General Practice'}]","[{'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013557', 'cui_str': 'economics'}, {'cui': 'C0010186', 'cui_str': 'Cost'}]",1844.0,0.0611986,"The present study aims at evaluating the effects and cost-effectiveness of a primary care team-based intervention using behavioural therapy elements and case management supported by eHealth components in patients with PD/AG or depression compared to treatment as usual. ","[{'ForeName': 'Karoline', 'Initials': 'K', 'LastName': 'Lukaschek', 'Affiliation': 'Institute of General Practice and Family Medicine, University Hospital of the Ludwig-Maximilians University of Munich, Pettenkoferstr 8a, 80336, Munich, Germany.'}, {'ForeName': 'Karola', 'Initials': 'K', 'LastName': 'Mergenthal', 'Affiliation': 'Institute of General Practice, Goethe-University, Frankfurt am Main, Germany.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Heider', 'Affiliation': 'Department of Health Economics and Health Services Research, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Hanke', 'Affiliation': 'Embloom GmbH, Bonn, Germany.'}, {'ForeName': 'Kathrein', 'Initials': 'K', 'LastName': 'Munski', 'Affiliation': 'Techniker Krankenkasse, Hamburg, Germany.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Moschner', 'Affiliation': 'Techniker Krankenkasse, Hamburg, Germany.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Emig', 'Affiliation': 'Association of Statutory Health Insurance Physicians Hesse, Frankfurt am Main, Germany.'}, {'ForeName': 'Marjan', 'Initials': 'M', 'LastName': 'van den Akker', 'Affiliation': 'Institute of General Practice, Goethe-University, Frankfurt am Main, Germany.'}, {'ForeName': 'Antonia', 'Initials': 'A', 'LastName': 'Zapf', 'Affiliation': 'Institute of Medical Biometry and Epidemiology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Karl', 'Initials': 'K', 'LastName': 'Wegscheider', 'Affiliation': 'Institute of Medical Biometry and Epidemiology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Hans-Helmut', 'Initials': 'HH', 'LastName': 'König', 'Affiliation': 'Department of Health Economics and Health Services Research, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Jochen', 'Initials': 'J', 'LastName': 'Gensichen', 'Affiliation': 'Institute of General Practice and Family Medicine, University Hospital of the Ludwig-Maximilians University of Munich, Pettenkoferstr 8a, 80336, Munich, Germany. jochen.gensichen@med.uni-muenchen.de.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Trials,['10.1186/s13063-019-3751-3'] 900,31886683,Parenting in 2 worlds: Effects of a culturally grounded parenting intervention for urban American Indians on participant cultural engagement.,"BACKGROUND Culturally appropriate, evidence-based prevention programs are seldom available to the growing majority of American Indians (AIs) who now live in cities. Parenting in 2 Worlds (P2W), a culturally grounded parenting intervention, was created to strengthen family functioning and reduce behavioral health risks in urban AI families from diverse tribal backgrounds. OBJECTIVES This study reports on the AI cultural engagement of the P2W participants as an outcome of the intervention. METHOD Data came from 575 parents of AI children (ages 10-17) in a randomized controlled trial in three Arizona cities. Parents were recruited through urban Indian centers and randomized to P2W or to an informational family health curriculum, Healthy Families in 2 Worlds (HF2W). Both P2W and HF2W consisted of 10 workshops delivered weekly by AI community facilitators. Pretests and posttests measured identification and engagement with traditional AI heritage, culture and practices. Tests of the efficacy of P2W versus HF2W used baseline adjusted regression models using FIML estimation to adjust for attrition, including random effects (site, facilitator), and controlling dosage. Moderated treatment effects by pretest levels of cultural engagement were tested with mean centered interactions. RESULTS Compared to parents in HF2W, those in P2W reported significantly larger increases in AI ethnic identity, AI spirituality, and positive mainstream cultural identification. Increases in cultural engagement were significantly larger for P2W participants who were relatively less culturally engaged at pretest. CONCLUSIONS Culturally adapted parenting interventions like P2W that effectively build on AI cultural heritage can also promote greater AI cultural identification and involvement. (PsycINFO Database Record (c) 2019 APA, all rights reserved).",2019,"Compared to parents in HF2W, those in P2W reported significantly larger increases in AI ethnic identity, AI spirituality, and positive mainstream cultural identification.","['Data came from 575 parents of AI children (ages 10-17', 'urban AI families from diverse tribal backgrounds', 'urban American Indians on participant cultural engagement', 'Parents were recruited through urban Indian centers and randomized to P2W or to an informational family health curriculum, Healthy Families in 2 Worlds (HF2W']",['culturally grounded parenting intervention'],"['AI ethnic identity, AI spirituality, and positive mainstream cultural identification', 'cultural engagement', 'behavioral health risks']","[{'cui': 'C0960273', 'cui_str': 'CAME'}, {'cui': 'C3844102', 'cui_str': '575'}, {'cui': 'C0030551', 'cui_str': 'Parent of (observable entity)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C1524069', 'cui_str': 'Indian (racial group)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0600220', 'cui_str': 'Family Health'}, {'cui': 'C0220815', 'cui_str': 'curriculum'}]",[],"[{'cui': 'C0237104', 'cui_str': 'Spiritualities'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0020792', 'cui_str': 'Identification'}, {'cui': 'C0870196', 'cui_str': 'Behavioral health (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",2019.0,0.0349673,"Compared to parents in HF2W, those in P2W reported significantly larger increases in AI ethnic identity, AI spirituality, and positive mainstream cultural identification.","[{'ForeName': 'Stephen S', 'Initials': 'SS', 'LastName': 'Kulis', 'Affiliation': 'Sanford School of Social and Family Dynamics.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Tsethlikai', 'Affiliation': 'Sanford School of Social and Family Dynamics.'}, {'ForeName': 'Mary L', 'Initials': 'ML', 'LastName': 'Harthun', 'Affiliation': 'Southwest Interdisciplinary Research Center.'}, {'ForeName': 'Patricia K', 'Initials': 'PK', 'LastName': 'Hibbeler', 'Affiliation': 'Phoenix Indian Center.'}, {'ForeName': 'Stephanie L', 'Initials': 'SL', 'LastName': 'Ayers', 'Affiliation': 'Southwest Interdisciplinary Research Center.'}, {'ForeName': 'Nicholet', 'Initials': 'N', 'LastName': 'Deschine Parkhurst', 'Affiliation': 'Southwest Interdisciplinary Research Center.'}]",Cultural diversity & ethnic minority psychology,['10.1037/cdp0000315'] 901,31833259,Characteristics and survival of ovarian cancer patients treated with neoadjuvant chemotherapy but not undergoing interval debulking surgery.,"OBJECTIVE Neoadjuvant chemotherapy (NACT) followed by interval debulking surgery (IDS) confers similar outcomes as primary debulking surgery and chemotherapy. Little is known about patients who receive NACT but do not undergo debulking surgery. Our aim was to characterize these patients. METHODS We prospectively identified patients with newly diagnosed stage III/IV ovarian cancer treated with NACT from 7/1/15-12/1/17. Fisher exact and Wilcoxon rank-sum tests were used to compare clinical characteristics by surgical status. The Kaplan-Meier method was used to estimate survival outcomes. Log-rank test and Cox proportional hazards model were applied to assess the relationship of covariates to outcome, and time-dependent covariates were applied to variables collected after diagnosis. RESULTS Of 224 women who received NACT, 162 (72%) underwent IDS and 62 (28%) did not undergo surgery. The non-surgical group was older (p<0.001), had higher Charlson comorbidity index (CCI; p<0.001), lower albumin levels (p=0.007), lower Karnofsky performance scores (p<0.001), and were more likely to have dose reductions in NACT (p<0.001). Reasons for no surgery included poor response to NACT (39%), death (15%), comorbidities (24%), patient preference (16%), and loss to follow-up (6%). The no surgery group had significantly worse overall survival (OS) than the surgery group (hazard ratio=3.34; 95% confidence interval=1.66-6.72; p<0.001), after adjustment for age, CCI, and dose reductions. CONCLUSIONS A significant proportion of women treated with NACT do not undergo IDS, and these women are older, frailer, and have worse OS. More studies are needed to find optimal therapies to maximize outcomes in this high-risk, elderly population.",2020,"The no surgery group had significantly worse overall survival (OS) than the surgery group (hazard ratio=3.34; 95% confidence interval=1.66-6.72; p<0.001), after adjustment for age, CCI, and dose reductions. ","['224 women who received NACT, 162 (72', 'patients with newly diagnosed stage III/IV ovarian cancer treated with NACT from 7/1/15-12/1/17', 'ovarian cancer patients treated with neoadjuvant chemotherapy but not undergoing interval debulking surgery']","['Neoadjuvant chemotherapy (NACT) followed by interval debulking surgery (IDS', 'NACT']","['higher Charlson comorbidity index (CCI; p<0.001), lower albumin levels', 'overall survival (OS', 'death', 'Karnofsky performance scores']","[{'cui': 'C4319560', 'cui_str': '224'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3 (qualifier value)'}, {'cui': 'C1140680', 'cui_str': 'Ovary Cancer'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C1706406', 'cui_str': 'Interventional debulking surgery (procedure)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C1706406', 'cui_str': 'Interventional debulking surgery (procedure)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C4546361', 'cui_str': 'Charlson Comorbidity Index (assessment scale)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0428519', 'cui_str': 'Albumin level - finding'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",224.0,0.119426,"The no surgery group had significantly worse overall survival (OS) than the surgery group (hazard ratio=3.34; 95% confidence interval=1.66-6.72; p<0.001), after adjustment for age, CCI, and dose reductions. ","[{'ForeName': 'Ying L', 'Initials': 'YL', 'LastName': 'Liu', 'Affiliation': 'Gynecologic Medical Oncology Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Olga T', 'Initials': 'OT', 'LastName': 'Filippova', 'Affiliation': 'Gynecology Service, Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Qin', 'Initials': 'Q', 'LastName': 'Zhou', 'Affiliation': 'Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Alexia', 'Initials': 'A', 'LastName': 'Iasonos', 'Affiliation': 'Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Dennis S', 'Initials': 'DS', 'LastName': 'Chi', 'Affiliation': 'Gynecology Service, Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Zivanovic', 'Affiliation': 'Gynecology Service, Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Yukio', 'Initials': 'Y', 'LastName': 'Sonoda', 'Affiliation': 'Gynecology Service, Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Ginger J', 'Initials': 'GJ', 'LastName': 'Gardner', 'Affiliation': 'Gynecology Service, Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Vance A', 'Initials': 'VA', 'LastName': 'Broach', 'Affiliation': 'Gynecology Service, Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Roisin E', 'Initials': 'RE', 'LastName': ""O'Cearbhaill"", 'Affiliation': 'Gynecologic Medical Oncology Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Jason A', 'Initials': 'JA', 'LastName': 'Konner', 'Affiliation': 'Gynecologic Medical Oncology Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Aghajanian', 'Affiliation': 'Gynecologic Medical Oncology Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Kara', 'Initials': 'K', 'LastName': 'Long Roche', 'Affiliation': 'Gynecology Service, Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'William P', 'Initials': 'WP', 'LastName': 'Tew', 'Affiliation': 'Gynecologic Medical Oncology Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}]",Journal of gynecologic oncology,['10.3802/jgo.2020.31.e17'] 902,31849155,Effects of nicorandil infusion on ECG parameters in patients with unstable angina pectoris and percutaneous coronary intervention.,"BACKGROUND Percutaneous coronary intervention (PCI) is effective in treating patients with acute coronary syndrome (ACS) but is associated with some serious complications. Nicorandil is an anti-anginal agent acting to improve microvascular circulation and to increase coronary blood flow. The objective of this article is to evaluate the effects of intracoronary injection followed with continuous intravenous injection of nicorandil on ECG parameters in patients with unstable angina pectoris (UA) undergoing PCI. METHODS A single-center, self-controlled clinical trial was conducted at the Second Hospital of Tianjin Medical University between January 2019 and April 2019. Sixty-three consecutive patients with UA who received coronary angiography and selective PCI were enrolled. ECG was recorded and analyzed before and 24 hr after nicorandil infusion. RESULTS Patients were divided into three groups: control group (n = 23, aged 63.43 ± 12.55 years), short-term, and prolonged use with nicorandil group (n = 20 and 20, aged 66.45 ± 8.06 years and 65.80 ± 9.49 years, respectively). Clinical characteristics and ECG parameters were similar before PCI among three groups (p > .05). In nicorandil treatment groups, intervals of QTd and Tp-e in patients post-PCI were significantly shorter than that in control and pre-PCI (p < .05). CONCLUSIONS Nicorandil infusion reduces QTd and Tp-e interval in patients with UA. Further studies will be needed to determine whether these electrophysiological changes are associated with a reduction of ventricular arrhythmias and improved outcomes.",2020,"In nicorandil treatment groups, intervals of QTd and Tp-e in patients post-PCI were significantly shorter than that in control and pre-PCI (p < .05). ","['patients with unstable angina pectoris and percutaneous coronary intervention', 'patients with unstable angina pectoris (UA) undergoing PCI.\nMETHODS\n\n\nA single-center, self-controlled clinical trial was conducted at the Second Hospital of Tianjin Medical University between January 2019 and April 2019', 'patients with acute coronary syndrome (ACS', 'Sixty-three consecutive patients with UA who received coronary angiography and selective PCI were enrolled', 'Patients were divided into three groups: control group (n\xa0=\xa023, aged 63.43\xa0±\xa012.55\xa0years), short-term, and prolonged use with nicorandil group (n\xa0=\xa020 and 20, aged 66.45\xa0±\xa08.06\xa0years and 65.80\xa0±\xa09.49\xa0years, respectively', 'patients with UA']","['Percutaneous coronary intervention (PCI', 'nicorandil', 'nicorandil infusion', 'Nicorandil', 'intracoronary injection']","['coronary blood flow', 'intervals of QTd and Tp-e', 'QTd and Tp-e interval', 'Clinical characteristics and ECG parameters', 'ECG parameters', 'ECG']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0002965', 'cui_str': 'Angina at Rest'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0684274', 'cui_str': 'Self Regulation'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0948089', 'cui_str': 'Acute Coronary Syndrome'}, {'cui': 'C4319614', 'cui_str': '63 (qualifier value)'}, {'cui': 'C0085532', 'cui_str': 'Angiography of coronary arteries'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0439590', 'cui_str': 'Prolonged (qualifier value)'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0068700', 'cui_str': 'Nicorandil'}]","[{'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}, {'cui': 'C0068700', 'cui_str': 'Nicorandil'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}]","[{'cui': 'C0232338', 'cui_str': 'Vascular flow, function (observable entity)'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C1623258', 'cui_str': 'ECG'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",63.0,0.0131258,"In nicorandil treatment groups, intervals of QTd and Tp-e in patients post-PCI were significantly shorter than that in control and pre-PCI (p < .05). ","[{'ForeName': 'Weiding', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'Tianjin Key Laboratory of Ionic-Molecular Function of Cardiovascular Disease, Department of Cardiology, Tianjin Institute of Cardiology, Second Hospital of Tianjin Medical University, Tianjin, China.'}, {'ForeName': 'Xu', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Tianjin Key Laboratory of Ionic-Molecular Function of Cardiovascular Disease, Department of Cardiology, Tianjin Institute of Cardiology, Second Hospital of Tianjin Medical University, Tianjin, China.'}, {'ForeName': 'Kangyin', 'Initials': 'K', 'LastName': 'Chen', 'Affiliation': 'Tianjin Key Laboratory of Ionic-Molecular Function of Cardiovascular Disease, Department of Cardiology, Tianjin Institute of Cardiology, Second Hospital of Tianjin Medical University, Tianjin, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Yin', 'Affiliation': 'Tianjin Key Laboratory of Ionic-Molecular Function of Cardiovascular Disease, Department of Cardiology, Tianjin Institute of Cardiology, Second Hospital of Tianjin Medical University, Tianjin, China.'}, {'ForeName': 'Mengqi', 'Initials': 'M', 'LastName': 'Gong', 'Affiliation': 'Tianjin Key Laboratory of Ionic-Molecular Function of Cardiovascular Disease, Department of Cardiology, Tianjin Institute of Cardiology, Second Hospital of Tianjin Medical University, Tianjin, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Tianjin Key Laboratory of Ionic-Molecular Function of Cardiovascular Disease, Department of Cardiology, Tianjin Institute of Cardiology, Second Hospital of Tianjin Medical University, Tianjin, China.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Tse', 'Affiliation': 'Tianjin Key Laboratory of Ionic-Molecular Function of Cardiovascular Disease, Department of Cardiology, Tianjin Institute of Cardiology, Second Hospital of Tianjin Medical University, Tianjin, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Wu', 'Affiliation': 'Department of Cardiology, Peking University First Hospital, Beijing, China.'}, {'ForeName': 'Guangping', 'Initials': 'G', 'LastName': 'Li', 'Affiliation': 'Tianjin Key Laboratory of Ionic-Molecular Function of Cardiovascular Disease, Department of Cardiology, Tianjin Institute of Cardiology, Second Hospital of Tianjin Medical University, Tianjin, China.'}, {'ForeName': 'Tong', 'Initials': 'T', 'LastName': 'Liu', 'Affiliation': 'Tianjin Key Laboratory of Ionic-Molecular Function of Cardiovascular Disease, Department of Cardiology, Tianjin Institute of Cardiology, Second Hospital of Tianjin Medical University, Tianjin, China.'}]","Annals of noninvasive electrocardiology : the official journal of the International Society for Holter and Noninvasive Electrocardiology, Inc",['10.1111/anec.12736'] 903,31268466,Temporal Changes in Coronary Hyperemic and Resting Hemodynamic Indices in Nonculprit Vessels of Patients With ST-Segment Elevation Myocardial Infarction.,"Importance Percutaneous coronary intervention (PCI) of nonculprit vessels among patients with ST-segment elevation myocardial infarction (STEMI) is associated with improved clinical outcome compared with culprit vessel-only PCI. Fractional flow reserve (FFR) and coronary flow reserve are hyperemic indices used to guide revascularization. Recently, instantaneous wave-free ratio was introduced as a nonhyperemic alternative to FFR. Whether these indices can be used in the acute setting of STEMI continues to be investigated. Objective To assess the value of hemodynamic indices in nonculprit vessels of patients with STEMI from the index event to 1-month follow-up. Design, Setting, and Participants This substudy of the Reducing Micro Vascular Dysfunction in Revascularized STEMI Patients by Off-target Properties of Ticagrelor (REDUCE-MVI) randomized clinical trial enrolled 98 patients with STEMI who had an angiographic intermediate stenosis in at least 1 nonculprit vessel. Patient enrollment was between May 1, 2015, and September 19, 2017. After successful primary PCI, nonculprit intracoronary hemodynamic measurements were performed and repeated at 1-month follow-up. Cardiac magnetic resonance imaging was performed from 2 to 7 days and 1 month after primary PCI. Main Outcomes and Measures The value of nonculprit instantaneous wave-free ratio, FFR, coronary flow reserve, hyperemic index of microcirculatory resistance, and resting microcirculatory resistance from the index event to 1-month follow-up. Results Of 73 patients with STEMI included in the final analysis, 59 (80.8%) were male, with a mean (SD) age of 60.8 (9.9) years. Instantaneous wave-free ratio (SD) did not change significantly (0.93 [0.07] vs 0.94 [0.06]; P = .12) and there was no change in resting distal pressure/aortic pressure (mean [SD], 0.94 [0.06] vs 0.95 [0.06]; P = .25) from the acute moment to 1-month follow-up. The FFR decreased (mean [SD], 0.88 [0.07] vs 0.86 [0.09]; P = .001) whereas coronary flow reserve increased (mean [SD], 2.9 [1.4] vs 4.1 [2.2]; P < .001). Hyperemic index of microcirculatory resistance decreased and resting microcirculatory resistance increased from the acute moment to follow-up. The decrease in distal pressure from rest to hyperemia was smaller at the acute moment vs follow-up (mean [SD], 10.6 [11.2] mm Hg vs 14.1 [14.2] mm Hg; P = .05). This blunted acute hyperemic response correlated with final infarct size (ρ, -0.29; P = .02). The resistive reserve ratio was lower at the acute moment vs follow-up (mean [SD], 3.4 [1.7] vs 5.0 [2.7]; P < .001). Conclusions and Relevance In the acute setting of STEMI, nonculprit coronary flow reserve was reduced and FFR was augmented, whereas instantaneous wave-free ratio was not altered. These results may be explained by an increased hyperemic microvascular resistance and a blunted adenosine responsiveness at the acute moment that was associated with infarct size.",2019,Instantaneous wave-free ratio (SD) did not change significantly (0.93 [0.07] vs 0.94 [0.06];,"['73 patients with STEMI included in the final analysis, 59 (80.8%) were male, with a mean (SD) age of 60.8 (9.9) years', 'Patients With ST-Segment Elevation Myocardial Infarction', 'patients with ST-segment elevation myocardial infarction (STEMI', '98 patients with STEMI who had an angiographic intermediate stenosis in at least 1 nonculprit vessel', 'nonculprit vessels of patients with STEMI from the index event to 1-month follow-up']","['Percutaneous coronary intervention (PCI', 'Ticagrelor', 'Cardiac magnetic resonance imaging']","['resistive reserve ratio', 'Fractional flow reserve (FFR) and coronary flow reserve', 'Coronary Hyperemic and Resting Hemodynamic Indices', 'distal pressure', 'resting distal pressure/aortic pressure', 'blunted acute hyperemic response', 'coronary flow reserve', 'value of nonculprit instantaneous wave-free ratio, FFR, coronary flow reserve, hyperemic index of microcirculatory resistance, and resting microcirculatory resistance', 'Hyperemic index of microcirculatory resistance decreased and resting microcirculatory resistance', 'Instantaneous wave-free ratio (SD', 'FFR', 'hyperemic microvascular resistance']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1536220', 'cui_str': 'ST Elevated Myocardial Infarction'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C1261287', 'cui_str': 'Stenosis'}, {'cui': 'C0148346', 'cui_str': 'Vessel'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]","[{'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}, {'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C1552358', 'cui_str': 'Magnetic resonance imaging'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C1299469', 'cui_str': 'Fractional flow reserve'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205108', 'cui_str': 'Distal (qualifier value)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0456180', 'cui_str': 'Aortic Blood Pressure'}, {'cui': 'C1997138', 'cui_str': 'Blunted'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0443258', 'cui_str': 'Microvascular (qualifier value)'}]",98.0,0.0728239,Instantaneous wave-free ratio (SD) did not change significantly (0.93 [0.07] vs 0.94 [0.06];,"[{'ForeName': 'Nina W', 'Initials': 'NW', 'LastName': 'van der Hoeven', 'Affiliation': 'Department of Cardiology, Amsterdam University Medical Center, Vrije Universiteit, Amsterdam, the Netherlands.'}, {'ForeName': 'Gladys N', 'Initials': 'GN', 'LastName': 'Janssens', 'Affiliation': 'Department of Cardiology, Amsterdam University Medical Center, Vrije Universiteit, Amsterdam, the Netherlands.'}, {'ForeName': 'Guus A', 'Initials': 'GA', 'LastName': 'de Waard', 'Affiliation': 'Department of Cardiology, Amsterdam University Medical Center, Vrije Universiteit, Amsterdam, the Netherlands.'}, {'ForeName': 'Henk', 'Initials': 'H', 'LastName': 'Everaars', 'Affiliation': 'Department of Cardiology, Amsterdam University Medical Center, Vrije Universiteit, Amsterdam, the Netherlands.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Broyd', 'Affiliation': 'Department of Cardiology, Barts Heart Centre, London, United Kingdom.'}, {'ForeName': 'Casper W H', 'Initials': 'CWH', 'LastName': 'Beijnink', 'Affiliation': 'Department of Cardiology, Amsterdam University Medical Center, Vrije Universiteit, Amsterdam, the Netherlands.'}, {'ForeName': 'Peter M', 'Initials': 'PM', 'LastName': 'van de Ven', 'Affiliation': 'Department of Epidemiology and Biostatistics, Amsterdam University Medical Center, Vrije Universiteit, Amsterdam, the Netherlands.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Nijveldt', 'Affiliation': 'Department of Cardiology, Amsterdam University Medical Center, Vrije Universiteit, Amsterdam, the Netherlands.'}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': 'Cook', 'Affiliation': 'Department of Cardiology, Hammersmith Hospital, Imperial College, London, United Kingdom.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Petraco', 'Affiliation': 'Department of Cardiology, Hammersmith Hospital, Imperial College, London, United Kingdom.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Ten Cate', 'Affiliation': 'Department of Cardiology, Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'Clemens', 'Initials': 'C', 'LastName': 'von Birgelen', 'Affiliation': 'Department of Cardiology, Medisch Spectrum Twente, Enschede, the Netherlands.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Escaned', 'Affiliation': 'Department of Cardiology, Hospital Clínico San Carlos El Instituto de Investigación Sanitaria del Hospital Clinic San Carlos and Universidad Complutense de Madrid, Madrid, Spain.'}, {'ForeName': 'Justin E', 'Initials': 'JE', 'LastName': 'Davies', 'Affiliation': 'Department of Cardiology, Hammersmith Hospital, Imperial College, London, United Kingdom.'}, {'ForeName': 'Maarten A H', 'Initials': 'MAH', 'LastName': 'van Leeuwen', 'Affiliation': 'Department of Cardiology, Amsterdam University Medical Center, Vrije Universiteit, Amsterdam, the Netherlands.'}, {'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'van Royen', 'Affiliation': 'Department of Cardiology, Amsterdam University Medical Center, Vrije Universiteit, Amsterdam, the Netherlands.'}]",JAMA cardiology,['10.1001/jamacardio.2019.2138'] 904,31866327,Adverse events in adults with latent tuberculosis infection receiving daily rifampicin or isoniazid: post-hoc safety analysis of two randomised controlled trials.,"BACKGROUND An important problem limiting treatment of latent tuberculosis infection is the occurrence of adverse events with isoniazid. We combined populations from phase 2 and phase 3 open-label, randomised controlled trials, to establish risk factors for adverse events during latent tuberculosis infection treatment. METHODS We did a post-hoc safety analysis based on data from two open-label, randomised controlled trials done in health-care facilities in Australia, Benin, Brazil, Canada, Ghana, Guinea, Indonesia, Saudi Arabia, and South Korea. Participants were consenting adults (aged ≥18 years) with a positive latent tuberculosis infection diagnostic test, indication for treatment, and without contraindications to rifampicin or isoniazid. Patients were centrally randomly assigned 1:1 to 4 months of daily 10 mg/kg rifampicin or 9 months of daily 5 mg/kg isoniazid. The primary outcome evaluated was adverse events (including grade 1-2 rash and all events of grade 3-5) resulting in permanent discontinuation of study medication and judged possibly or probably related to study drug by a masked, independent, three-member adjudication panel (trial registration: NCT00170209; NCT00931736). FINDINGS Participants were recruited from April 27, 2004, up until Jan 31, 2007 (phase 2), and Oct 1, 2009, up until Dec 31, 2014 (phase 3). The safety populations for each group comprised 3205 individuals receiving isoniazid and 3280 receiving rifampicin. Among those receiving isoniazid, 86 (2·7%) of 3205 had grade 1-2 rash or any grade 3-5 adverse events, more than the 50 (1·5%) of 3280 who had these events with rifampicin (risk difference -1·2%, 95% CI -1·9 to -0·5). Age was associated with adverse events in adults receiving isoniazid. Compared with individuals aged 18-34 years, the adjusted odds ratio (OR) for adverse events was 1·8 (95% CI 1·1-3·0) for individuals aged 35-64 years and 3·0 (1·2-6·8) for individuals aged 65-90 years. With rifampicin, adverse events were associated with inconsistent medication adherence (adjusted OR 2·0, 1·1-3·6) and concomitant medication use (2·8, 1·5-5·2), but not age, with an adjusted OR of 1·1 (0·6-2·1) for individuals aged 35-64 years and 1·7 (0·5-4·7) for individuals aged 65-90 years. One treatment-related death occurred in the isoniazid group. INTERPRETATION In patients without a contraindication, rifampicin is likely to be the safest latent tuberculosis infection treatment option. With more widespread use of rifampicin, rare, but serious adverse events might be seen. However, within these randomised trials, rifampicin was safer than isoniazid and adverse events were not associated with older age. Therefore, rifampicin should become a primary treatment option for latent tuberculosis infection based on its safety. FUNDING Canadian Institutes of Health Research.",2020,"Compared with individuals aged 18-34 years, the adjusted odds ratio (OR) for adverse events was 1·8 (95% CI 1·1-3·0) for individuals aged 35-64 years and 3·0 (1·2-6·8) for individuals aged 65-90 years.","['adults with latent tuberculosis infection receiving daily', 'health-care facilities in Australia, Benin, Brazil, Canada, Ghana, Guinea, Indonesia, Saudi Arabia, and South Korea', '3205 individuals receiving', 'Participants were recruited from April 27, 2004, up until Jan 31, 2007 (phase 2), and Oct 1, 2009, up until Dec 31, 2014 (phase 3', 'Participants were consenting adults (aged ≥18 years) with a positive latent tuberculosis infection diagnostic test, indication for treatment, and without contraindications to', 'individuals aged 18-34 years, the adjusted odds ratio (OR) for adverse events was 1·8 (95% CI 1·1-3·0) for individuals aged 35-64 years and 3·0 (1·2-6·8) for individuals aged 65-90 years']","['rifampicin or 9 months of daily 5 mg/kg isoniazid', 'rifampicin', 'isoniazid', 'rifampicin or isoniazid']","['grade 1-2 rash or any grade 3-5 adverse events', 'death', 'adverse events (including grade 1-2 rash and all events of grade 3-5) resulting in permanent discontinuation of study medication and judged possibly or probably related to study drug', 'adverse events', 'Adverse events']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1609538', 'cui_str': 'Latent Tuberculosis Infection'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0005005', 'cui_str': 'Dahomey'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0017516', 'cui_str': 'Republic of Ghana'}, {'cui': 'C0018381', 'cui_str': 'Guinea, Republic of'}, {'cui': 'C0021247', 'cui_str': 'East Indies'}, {'cui': 'C0036243', 'cui_str': 'Kingdom of Saudi Arabia'}, {'cui': 'C0022773', 'cui_str': 'South Korea'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0439560', 'cui_str': 'Phase 2 (qualifier value)'}, {'cui': 'C0439561', 'cui_str': 'Phase 3 (qualifier value)'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0086143'}, {'cui': 'C0392360', 'cui_str': 'Reason for (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0522473', 'cui_str': 'Contraindication to (contextual qualifier) (qualifier value)'}, {'cui': 'C0028873', 'cui_str': 'Risk Ratio'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]","[{'cui': 'C0035608', 'cui_str': 'rifampicin'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0022209', 'cui_str': 'isoniazid'}]","[{'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0015230', 'cui_str': 'Skin Rash'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0332294', 'cui_str': 'Resulting in (attribute)'}, {'cui': 'C0205355', 'cui_str': 'Permanent (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0221191', 'cui_str': 'Judge (occupation)'}, {'cui': 'C2362652', 'cui_str': 'Possible diagnosis (contextual qualifier) (qualifier value)'}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis (contextual qualifier) (qualifier value)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}]",,0.176653,"Compared with individuals aged 18-34 years, the adjusted odds ratio (OR) for adverse events was 1·8 (95% CI 1·1-3·0) for individuals aged 35-64 years and 3·0 (1·2-6·8) for individuals aged 65-90 years.","[{'ForeName': 'Jonathon R', 'Initials': 'JR', 'LastName': 'Campbell', 'Affiliation': 'Respiratory Epidemiology and Clinical Research Unit, Montreal Chest Institute, McGill International TB Centre, McGill University Health Centre Research Institute, McGill University, Montréal, QC, Canada; Department of Epidemiology and Biostatistics, McGill University, Montréal, QC, Canada.'}, {'ForeName': 'Anete', 'Initials': 'A', 'LastName': 'Trajman', 'Affiliation': 'Respiratory Epidemiology and Clinical Research Unit, Montreal Chest Institute, McGill International TB Centre, McGill University Health Centre Research Institute, McGill University, Montréal, QC, Canada; Federal University of Rio de Janeiro, Rio de Janeiro, Brazil.'}, {'ForeName': 'Victoria J', 'Initials': 'VJ', 'LastName': 'Cook', 'Affiliation': 'Faculty of Medicine, University of British Columbia, Vancouver, BC, Canada; Provincial TB Services, British Columbia Centre for Disease Control, Vancouver, BC, Canada.'}, {'ForeName': 'James C', 'Initials': 'JC', 'LastName': 'Johnston', 'Affiliation': 'Respiratory Epidemiology and Clinical Research Unit, Montreal Chest Institute, McGill International TB Centre, McGill University Health Centre Research Institute, McGill University, Montréal, QC, Canada; Faculty of Medicine, University of British Columbia, Vancouver, BC, Canada; Provincial TB Services, British Columbia Centre for Disease Control, Vancouver, BC, Canada.'}, {'ForeName': 'Menonli', 'Initials': 'M', 'LastName': 'Adjobimey', 'Affiliation': 'National Hospitalier Universitaire de Pneumo-Phtisiologie, Cotonou, Benin.'}, {'ForeName': 'Rovina', 'Initials': 'R', 'LastName': 'Ruslami', 'Affiliation': 'Department of Biomedical Sciences, Division of Pharmacology and Therapy, Faculty of Medicine, Universitas Padjadjaran, Bandung, Indonesia.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Eisenbeis', 'Affiliation': 'University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Federica', 'Initials': 'F', 'LastName': 'Fregonese', 'Affiliation': 'Respiratory Epidemiology and Clinical Research Unit, Montreal Chest Institute, McGill International TB Centre, McGill University Health Centre Research Institute, McGill University, Montréal, QC, Canada.'}, {'ForeName': 'Chantal', 'Initials': 'C', 'LastName': 'Valiquette', 'Affiliation': 'Respiratory Epidemiology and Clinical Research Unit, Montreal Chest Institute, McGill International TB Centre, McGill University Health Centre Research Institute, McGill University, Montréal, QC, Canada.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Benedetti', 'Affiliation': 'Respiratory Epidemiology and Clinical Research Unit, Montreal Chest Institute, McGill International TB Centre, McGill University Health Centre Research Institute, McGill University, Montréal, QC, Canada; Department of Epidemiology and Biostatistics, McGill University, Montréal, QC, Canada.'}, {'ForeName': 'Dick', 'Initials': 'D', 'LastName': 'Menzies', 'Affiliation': 'Respiratory Epidemiology and Clinical Research Unit, Montreal Chest Institute, McGill International TB Centre, McGill University Health Centre Research Institute, McGill University, Montréal, QC, Canada; Department of Epidemiology and Biostatistics, McGill University, Montréal, QC, Canada. Electronic address: dick.menzies@mcgill.ca.'}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(19)30575-4'] 905,31866328,"Inhaled amikacin adjunctive to intravenous standard-of-care antibiotics in mechanically ventilated patients with Gram-negative pneumonia (INHALE): a double-blind, randomised, placebo-controlled, phase 3, superiority trial.","BACKGROUND Treatment of ventilated pneumonia is often unsuccessful, even when patients are treated according to established guidelines. Therefore, we aimed to investigate the efficacy of the combination drug device Amikacin Inhale as an adjunctive therapy to intravenous standard-of-care antibiotics for pneumonia caused by Gram-negative pathogens in intubated and mechanically ventilated patients. METHODS INHALE was a prospective, double-blind, randomised, placebo-controlled, phase 3 study comprising two trials (INHALE 1 and INHALE 2) done in 153 hospital intensive-care units in 25 countries. Eligible patients were aged 18 years or older; had pneumonia that had been diagnosed by chest radiography and that was documented as being caused by or showing two risk factors for a Gram-negative, multidrug-resistant pathogen; were intubated and mechanically ventilated; had impaired oxygenation within 48 h before screening; and had a modified Clinical Pulmonary Infection Score of at least 6. Patients were stratified by region and disease severity (according to their Acute Physiology and Chronic Health Evaluation [APACHE] II score) and randomly assigned (1:1) via an interactive voice-recognition system to receive 400 mg amikacin (Amikacin Inhale) or saline placebo, both of which were aerosolised, administered every 12 h for 10 days via the same synchronised inhalation system, and given alongside standard-of-care intravenous antibiotics. All patients and all staff involved in administering devices and monitoring outcomes were masked to treatment assignment. The primary endpoint, survival at days 28-32, was analysed in all patients who received at least one dose of study drug, were infected with a Gram-negative pathogen, and had an APACHE II score of at least 10 at diagnosis. Safety analyses were done in all patients who received at least one dose of study drug. This study is registered with ClinicalTrials.gov, numbers NCT01799993 and NCT00805168. FINDINGS Between April 13, 2013, and April 7, 2017, 807 patients were assessed for eligibility and 725 were randomly assigned to Amikacin Inhale (362 patients) or aerosolised placebo (363 patients). 712 patients received at least one dose of study drug (354 in the Amikacin Inhale group and 358 in the placebo group), although one patient assigned to Amikacin Inhale received placebo in error and was included in the placebo group for safety analyses. 508 patients (255 in the Amikacin Inhale group and 253 in the placebo group) were assessed for the primary endpoint. We found no between-group difference in survival: 191 (75%) patients in the Amikacin Inhale group versus 196 (77%) patients in the placebo group survived until days 28-32 (odds ratio 0·841, 95% CI 0·554-1·277; p=0·43). Similar proportions of patients in the two treatment groups had a treatment-emergent adverse event (295 [84%] of 353 patients in the Amikacin Inhale group vs 303 [84%] of 359 patients in the placebo group) or a serious treatment-emergent adverse event (101 [29%] patients vs 97 [27%] patients). INTERPRETATION Our findings do not support use of inhaled amikacin adjunctive to standard-of-care intravenous therapy in mechanically ventilated patients with Gram-negative pneumonia. FUNDING Bayer AG.",2020,"We found no between-group difference in survival: 191 (75%) patients in the Amikacin Inhale group versus 196 (77%) patients in the placebo group survived until days 28-32 (odds ratio 0·841, 95% CI 0·554-1·277; p=0·43).","['153 hospital intensive-care units in 25 countries', 'mechanically ventilated patients with Gram-negative pneumonia (INHALE', 'Eligible patients were aged 18 years or older; had pneumonia that had been diagnosed by chest radiography and that was documented as being caused by or showing two risk factors for a Gram-negative, multidrug-resistant pathogen; were intubated and mechanically ventilated; had impaired oxygenation within 48 h before screening; and had a modified Clinical Pulmonary Infection Score of at least 6', 'Between April 13, 2013, and April 7, 2017, 807 patients were assessed for eligibility and 725 were randomly assigned to', '508 patients (255 in the Amikacin Inhale group and 253 in the', 'intubated and mechanically ventilated patients', 'mechanically ventilated patients with Gram-negative pneumonia', 'Patients were stratified by region and disease severity (according to their Acute Physiology and Chronic Health Evaluation [APACHE] II score) and randomly assigned (1:1) via an', '363 patients', '712 patients received at least one dose of study drug (354 in the Amikacin Inhale group and 358 in the']","['amikacin adjunctive to intravenous standard-of-care antibiotics', 'placebo', 'Amikacin Inhale received placebo', 'amikacin adjunctive', 'aerosolised placebo', 'interactive voice-recognition system to receive 400 mg amikacin (Amikacin Inhale) or saline placebo', 'Amikacin']","['survival', 'serious treatment-emergent adverse event', 'treatment-emergent adverse event']","[{'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0854248', 'cui_str': 'Pneumonia caused by Gram negative bacteria (disorder)'}, {'cui': 'C0004048', 'cui_str': 'Inhalation'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C0034571', 'cui_str': 'radiography'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0439208', 'cui_str': 'gram (qualifier value)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0332325', 'cui_str': 'Resistant (qualifier value)'}, {'cui': 'C0450254', 'cui_str': 'Pathogen'}, {'cui': 'C0221099', 'cui_str': 'Impaired (qualifier value)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0876973', 'cui_str': 'Pulmonary infection'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0002499', 'cui_str': 'Amikacin'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205363', 'cui_str': 'Stratified (qualifier value)'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0243028', 'cui_str': 'APACHE II'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}]","[{'cui': 'C0002499', 'cui_str': 'Amikacin'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C2936643', 'cui_str': 'Standard of Care'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0004048', 'cui_str': 'Inhalation'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0524637', 'cui_str': 'Recognition (Psychology)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}]","[{'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",807.0,0.74974,"We found no between-group difference in survival: 191 (75%) patients in the Amikacin Inhale group versus 196 (77%) patients in the placebo group survived until days 28-32 (odds ratio 0·841, 95% CI 0·554-1·277; p=0·43).","[{'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Niederman', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, New York Presbyterian/Weill Cornell Medical Center, New York, NY, USA. Electronic address: msn9004@med.cornell.edu.'}, {'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Alder', 'Affiliation': 'Anti-Infective Consulting, Margaretville, NY, USA.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Bassetti', 'Affiliation': 'Infectious Diseases Clinic, Department of Health Sciences, University of Genoa and Policlinico San Martino Hospital, Genoa, Italy; Department of Health Sciences, University of Genoa, Genoa, Italy.'}, {'ForeName': 'Francis', 'Initials': 'F', 'LastName': 'Boateng', 'Affiliation': 'Bayer Healthcare Inc, Whippany, NJ, USA.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Cao', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, China-Japan Friendship Hospital, Beijing, China.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Corkery', 'Affiliation': 'Novartis Pharmaceuticals, San Carlos, CA, USA.'}, {'ForeName': 'Rajiv', 'Initials': 'R', 'LastName': 'Dhand', 'Affiliation': 'Department of Medicine, University of Tennessee Graduate School of Medicine, Knoxville, TN, USA.'}, {'ForeName': 'Keith S', 'Initials': 'KS', 'LastName': 'Kaye', 'Affiliation': 'Department of Internal Medicine, University of Michigan Medical School, Ann Arbor, MI, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Lawatscheck', 'Affiliation': 'Bayer AG, Berlin, Germany.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'McLeroth', 'Affiliation': 'Covance, Princeton, NJ, USA.'}, {'ForeName': 'David P', 'Initials': 'DP', 'LastName': 'Nicolau', 'Affiliation': 'Center for Anti-Infective Research and Development, Hartford Hospital, Hartford, CT, USA.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, China-Japan Friendship Hospital, Beijing, China.'}, {'ForeName': 'G Christopher', 'Initials': 'GC', 'LastName': 'Wood', 'Affiliation': 'Department of Clinical Pharmacy and Translational Science, University of Tennessee Health Science Center, University of Tennessee, Memphis, TN, USA.'}, {'ForeName': 'Richard G', 'Initials': 'RG', 'LastName': 'Wunderink', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Chastre', 'Affiliation': 'Intensive Care Unit, Sorbonne University Hospitals, Paris, France.'}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(19)30574-2'] 906,30963440,Randomized Trial of a Lifestyle Intervention for Urban Low-Income African Americans with Type 2 Diabetes.,"BACKGROUND African Americans suffer more than non-Hispanic whites from type 2 diabetes, but diabetes self-management education (DSME) has been less effective at improving glycemic control for African Americans. Our objective was to determine whether a novel, culturally tailored DSME intervention would result in sustained improvements in glycemic control in low-income African-American patients of public hospital clinics. RESEARCH DESIGN AND METHODS This randomized controlled trial (n = 211) compared changes in hemoglobin A1c (A1c) at 6, 12, and 18 months between two arms: (1) Lifestyle Improvement through Food and Exercise (LIFE), a culturally tailored, 28-session community-based intervention, focused on diet and physical activity, and (2) a standard of care comparison group receiving two group DSME classes. Cluster-adjusted ANCOVA modeling was used to assess A1c changes from baseline to 6, 12, and 18 months, respectively, between arms. RESULTS At 6 months, A1c decreased significantly more in the intervention group than the control group (- 0.76 vs - 0.21%, p = 0.03). However, by 12 and 18 months, the difference was no longer significant (12 months - 0.63 intervention vs - 0.45 control, p = 0.52). There was a decrease in A1c over 18 months in both the intervention (β = - 0.026, p = 0.003) and the comparison arm (β = - 0.018, p = 0.048) but no difference in trend (p = 0.472) between arms. The intervention group had greater improvements in nutrition knowledge (11.1 vs 6.0 point change, p = 0.002) and diet quality (4.0 vs - 0.5 point change, p = 0.018) while the comparison group had more participants with improved medication adherence (24% vs 10%, p < 0.05) at 12 months. CONCLUSIONS The LIFE intervention resulted in improved nutrition knowledge and diet quality and the comparison intervention resulted in improved medication adherence. LIFE participants showed greater A1c reduction than standard of care at 6 months but the difference between groups was no longer significant at 12 and 18 months. NIH TRIAL REGISTRY NUMBER NCT01901952.",2019,"LIFE participants showed greater A1c reduction than standard of care at 6 months but the difference between groups was no longer significant at 12 and 18 months. ","['Urban Low-Income African Americans with Type 2 Diabetes', 'African Americans', 'African Americans suffer more than non-Hispanic whites from type 2 diabetes, but diabetes self-management education (DSME', 'low-income African-American patients of public hospital clinics']","['Lifestyle Improvement through Food and Exercise (LIFE), a culturally tailored, 28-session community-based intervention, focused on diet and physical activity, and (2) a standard of care comparison group receiving two group DSME classes', 'Lifestyle Intervention', 'LIFE intervention', 'DSME intervention']","['diet quality', 'medication adherence', 'nutrition knowledge', 'nutrition knowledge and diet quality', 'changes in hemoglobin A1c (A1c']","[{'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0302604', 'cui_str': 'Low income'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C1319140', 'cui_str': 'Diabetes self-management'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0020022', 'cui_str': 'Hospitals, Public'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}]","[{'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C2936643', 'cui_str': 'Standard of Care'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}, {'cui': 'C0376558', 'cui_str': 'Life'}]","[{'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C2364172', 'cui_str': 'Medication Adherence'}, {'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C4521595', 'cui_str': 'Lcpl'}]",,0.0685125,"LIFE participants showed greater A1c reduction than standard of care at 6 months but the difference between groups was no longer significant at 12 and 18 months. ","[{'ForeName': 'Elizabeth B', 'Initials': 'EB', 'LastName': 'Lynch', 'Affiliation': 'Department of Preventive Medicine, Rush University Medical Center, 1700 West Van Buren, Suite 470, Chicago, IL, 60625, USA. Elizabeth_lynch@rush.edu.'}, {'ForeName': 'Laurin', 'Initials': 'L', 'LastName': 'Mack', 'Affiliation': 'Department of Behavioral Sciences, Rush University Medical Center, Chicago, IL, 60625, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Avery', 'Affiliation': 'Department of Preventive Medicine, Rush University Medical Center, 1700 West Van Buren, Suite 470, Chicago, IL, 60625, USA.'}, {'ForeName': 'Yamin', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Preventive Medicine, Rush University Medical Center, 1700 West Van Buren, Suite 470, Chicago, IL, 60625, USA.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Dawar', 'Affiliation': 'Department of Preventive Medicine, Rush University Medical Center, 1700 West Van Buren, Suite 470, Chicago, IL, 60625, USA.'}, {'ForeName': 'DeJuran', 'Initials': 'D', 'LastName': 'Richardson', 'Affiliation': 'Department of Preventive Medicine, Rush University Medical Center, 1700 West Van Buren, Suite 470, Chicago, IL, 60625, USA.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Keim', 'Affiliation': 'Department of Nutrition, Rush University Medical Center, Chicago, IL, 60625, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Ventrelle', 'Affiliation': 'Department of Preventive Medicine, Rush University Medical Center, 1700 West Van Buren, Suite 470, Chicago, IL, 60625, USA.'}, {'ForeName': 'Bradley M', 'Initials': 'BM', 'LastName': 'Appelhans', 'Affiliation': 'Department of Preventive Medicine, Rush University Medical Center, 1700 West Van Buren, Suite 470, Chicago, IL, 60625, USA.'}, {'ForeName': 'Bettina', 'Initials': 'B', 'LastName': 'Tahsin', 'Affiliation': 'Division of Endocrinology, Department of Internal Medicine, Rush University Medical Center, Chicago, IL, 60612, USA.'}, {'ForeName': 'Leon', 'Initials': 'L', 'LastName': 'Fogelfeld', 'Affiliation': 'Division of Endocrinology, Department of Internal Medicine, Rush University Medical Center, Chicago, IL, 60612, USA.'}]",Journal of general internal medicine,['10.1007/s11606-019-04894-y'] 907,31301615,"Efficacy and safety of bupropion hydrochloride extended-release versus escitalopram oxalate in Chinese patients with major depressive disorder: Results from a randomized, double-blind, non-inferiority trial.","BACKGROUND This study evaluated the non-inferiority of bupropion extended-release (XL) compared to escitalopram for acute-phase treatment of Chinese patients with major depressive disorder (MDD). METHODS This randomized (1:1), double-blind, active-control study conducted between February 2015 and October 2016 included patients with MDD (DSM-IV) (N = 538). The treatment phase had three dose levels (level 1 [Week 1], level 2 [Week 2-4], and level 3 [Week 5-8]), which included either bupropion XL 150 mg, 300 mg, 300 mg or escitalopram 10 mg, 10 mg, 10-20 mg (once-daily), respectively. Primary outcome was mean change from baseline in Hamilton Depression Rating Scale-17 (HAMD-17) total score at Week 8. RESULTS Overall, 534 patients (bupropion XL, n = 266; escitalopram, n = 268) received at least one dose of study medication. The least square mean (standard error) change from baseline in HAMD-17 total score at Week 8 was -14.5 (0.41) in bupropion XL group and -15.4 (0.39) in escitalopram group (mean difference: 0.8 [-0.27, 1.94]). The response rate was 69.6% versus 72.9%, remission rate was 39.7% versus 47.2%, sustained response rate was 51.6% versus 56.3%, and sustained remission rate was 25.5% versus 28.6%, respectively, for bupropion XL versus escitalopram group. Adverse events were reported by 313 patients (bupropion XL, n = 157; escitalopram, n = 156); the most common on-treatment adverse event in both groups was nausea (10.5% versus 18.7%, respectively). LIMITATIONS A non-inferiority short-term (8 weeks) study without a placebo arm. CONCLUSION Results from this study demonstrated that the efficacy of bupropion XL was non-inferior to that of escitalopram in Chinese patients with MDD.",2019,"The response rate was 69.6% versus 72.9%, remission rate was 39.7% versus 47.2%, sustained response rate was 51.6% versus 56.3%, and sustained remission rate was 25.5% versus 28.6%, respectively, for bupropion XL versus escitalopram group.","['Chinese patients with major depressive disorder', '534 patients (bupropion XL, n\u202f=\u202f266; escitalopram, n\u202f=\u202f268', 'February 2015 and October 2016 included patients with MDD (DSM-IV', 'Chinese patients with MDD', 'Chinese patients with major depressive disorder (MDD']","['bupropion XL', 'escitalopram', 'placebo', 'bupropion extended-release (XL', 'bupropion hydrochloride extended-release versus escitalopram oxalate']","['response rate', 'remission rate', 'least square mean (standard error) change from baseline in HAMD-17 total score', 'Adverse events', 'sustained response rate', 'mean change from baseline in Hamilton Depression Rating Scale-17 (HAMD-17) total score', 'Efficacy and safety', 'sustained remission rate', 'nausea']","[{'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C0085208', 'cui_str': 'Bupropion'}, {'cui': 'C1099456', 'cui_str': 'Escitalopram'}, {'cui': 'C4517673', 'cui_str': '268'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0220952', 'cui_str': 'DSM-IV'}]","[{'cui': 'C0085208', 'cui_str': 'Bupropion'}, {'cui': 'C1099456', 'cui_str': 'Escitalopram'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0231449', 'cui_str': 'Extended (qualifier value)'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0700563', 'cui_str': 'Bupropion Hydrochloride'}, {'cui': 'C1170746', 'cui_str': 'Escitalopram oxalate'}]","[{'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0023189', 'cui_str': 'Least Squares'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0222045'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}]",534.0,0.682707,"The response rate was 69.6% versus 72.9%, remission rate was 39.7% versus 47.2%, sustained response rate was 51.6% versus 56.3%, and sustained remission rate was 25.5% versus 28.6%, respectively, for bupropion XL versus escitalopram group.","[{'ForeName': 'Yifeng', 'Initials': 'Y', 'LastName': 'Shen', 'Affiliation': 'Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China; Shanghai Key Laboratory of Psychotic Disorders, Shanghai, China.'}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Zhao', 'Affiliation': 'Depression Treatment Center, Beijing Anding Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Yimin', 'Initials': 'Y', 'LastName': 'Yu', 'Affiliation': 'Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China; Shanghai Key Laboratory of Psychotic Disorders, Shanghai, China.'}, {'ForeName': 'Yunlong', 'Initials': 'Y', 'LastName': 'Tan', 'Affiliation': 'Beijing HuiLongGuan Hospital, Peking University, Beijing, China.'}, {'ForeName': 'Honggeng', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Department of Psychiatry, Brains Hospital of Hunan Province, Changsha, China.'}, {'ForeName': 'Xiufeng', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': 'Department of Psychiatry, First Affiliated Hospital of Kunming Medical University, Kunming, China.'}, {'ForeName': 'Zhiyang', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China; Shanghai Key Laboratory of Psychotic Disorders, Shanghai, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China; Shanghai Key Laboratory of Psychotic Disorders, Shanghai, China.'}, {'ForeName': 'Jingqiu', 'Initials': 'J', 'LastName': 'Hu', 'Affiliation': 'GlaxoSmithKline (China) R&D Company Limited, Shanghai, China.'}, {'ForeName': 'Jinhua', 'Initials': 'J', 'LastName': 'Zhong', 'Affiliation': 'GlaxoSmithKline (China) R&D Company Limited, Shanghai, China.'}, {'ForeName': 'Huafang', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China; Shanghai Key Laboratory of Psychotic Disorders, Shanghai, China. Electronic address: lhlh_5@163.com.'}]",Journal of affective disorders,['10.1016/j.jad.2019.07.023'] 908,31614373,Endocuff vision-assisted vs. standard polyp resection in the colorectum (the EVASTA study): a prospective randomized study.,"BACKGROUND Cap-assisted colonoscopy is frequently used to facilitate adenoma detection during endoscopy. However, data on how cap assistance influences polyp resection are scarce. We aimed to evaluate the impact of cap assistance with the Endocuff vision device (EVD) on the resection time for colorectal polyps in patients undergoing colonoscopy. METHODS : A randomized, prospective study was performed in a university hospital in Germany. A total of 250 patients were randomly assigned 1:1 to undergo either colonoscopy with the EVD (EVD arm) or standard colonoscopy without the use of a cap (standard arm). The primary outcome was the average duration of polypectomy. Secondary outcomes included adenoma detection rate, cecal and ileal intubation times, and propofol dosage. RESULTS The use of EVD led to a significant reduction in the median polypectomy time in the EVD vs. standard arm (54 vs. 80 seconds, respectively; P  = 0.02). This effect was strongest for polyps ≥ 6 mm. Compared with the standard group, Endocuff assistance also resulted in a shorter cecal intubation time (6 vs. 8 minutes; P  = 0.03) and overall colonoscopy time (23 vs. 27 minutes; P  = 0.02). In contrast, no difference in withdrawal time was observed. The polyp and adenoma detection rates did not differ significantly between the two groups. CONCLUSION Endocuff-assisted colonoscopy reduces the duration of polypectomy, which may be due to a more stable scope position during resection. Further studies are needed to investigate whether comparable effects will be seen for other interventions, such as clipping or biopsy sampling.",2020,"The use of EVD led to a significant reduction in the median polypectomy time in the EVD vs. standard arm (54 vs. 80 seconds, respectively; P  = 0.02).","['university hospital in Germany', 'patients undergoing colonoscopy', 'A total of 250 patients']","['colonoscopy with the EVD (EVD arm) or standard colonoscopy without the use of a cap (standard arm', 'Endocuff-assisted colonoscopy', 'cap assistance with the Endocuff vision device (EVD', 'Endocuff vision-assisted vs. standard polyp resection']","['duration of polypectomy', 'average duration of polypectomy', 'shorter cecal intubation time', 'median polypectomy time', 'polyp and adenoma detection rates', 'adenoma detection rate, cecal and ileal intubation times, and propofol dosage', 'withdrawal time', 'overall colonoscopy time']","[{'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0009378', 'cui_str': 'Endoscopy of colon'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C2348831', 'cui_str': '250'}]","[{'cui': 'C0009378', 'cui_str': 'Endoscopy of colon'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0179586', 'cui_str': 'Cap (physical object)'}, {'cui': 'C0042789', 'cui_str': 'Vision'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0032584', 'cui_str': 'Polyp (morphologic abnormality)'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}]","[{'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0521210', 'cui_str': 'Resection of polyp'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0032584', 'cui_str': 'Polyp (morphologic abnormality)'}, {'cui': 'C0001430', 'cui_str': 'Adenoma'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0178602', 'cui_str': 'Dosages (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0009378', 'cui_str': 'Endoscopy of colon'}]",250.0,0.0984559,"The use of EVD led to a significant reduction in the median polypectomy time in the EVD vs. standard arm (54 vs. 80 seconds, respectively; P  = 0.02).","[{'ForeName': 'Guido', 'Initials': 'G', 'LastName': 'von Figura', 'Affiliation': 'II. Medizinische Klinik, Klinikum rechts der Isar der Technischen Universität München, Munich, Germany.'}, {'ForeName': 'Moritz', 'Initials': 'M', 'LastName': 'Hasenöhrl', 'Affiliation': 'II. Medizinische Klinik, Klinikum rechts der Isar der Technischen Universität München, Munich, Germany.'}, {'ForeName': 'Bernhard', 'Initials': 'B', 'LastName': 'Haller', 'Affiliation': 'Institut für Medizinische Informatik, Statistik und Epidemiologie, Klinikum rechts der Isar der Technischen Universität München, Munich, Germany.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Poszler', 'Affiliation': 'II. Medizinische Klinik, Klinikum rechts der Isar der Technischen Universität München, Munich, Germany.'}, {'ForeName': 'Jörg', 'Initials': 'J', 'LastName': 'Ulrich', 'Affiliation': 'II. Medizinische Klinik, Klinikum rechts der Isar der Technischen Universität München, Munich, Germany.'}, {'ForeName': 'Hayley', 'Initials': 'H', 'LastName': 'Brown', 'Affiliation': 'II. Medizinische Klinik, Klinikum rechts der Isar der Technischen Universität München, Munich, Germany.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Abdelhafez', 'Affiliation': 'II. Medizinische Klinik, Klinikum rechts der Isar der Technischen Universität München, Munich, Germany.'}, {'ForeName': 'Roland M', 'Initials': 'RM', 'LastName': 'Schmid', 'Affiliation': 'II. Medizinische Klinik, Klinikum rechts der Isar der Technischen Universität München, Munich, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'von Delius', 'Affiliation': 'Medizinische Klinik II, RoMed Klinikum Rosenheim, Rosenheim, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Klare', 'Affiliation': 'II. Medizinische Klinik, Klinikum rechts der Isar der Technischen Universität München, Munich, Germany.'}]",Endoscopy,['10.1055/a-1018-1870'] 909,31326319,"Biomarkers of extracellular matrix turnover in patients with idiopathic pulmonary fibrosis given nintedanib (INMARK study): a randomised, placebo-controlled study.","BACKGROUND A hallmark of idiopathic pulmonary fibrosis is the excess accumulation of extracellular matrix in the lungs. Degradation of extracellular matrix generates free-circulating protein fragments called neoepitopes. The aim of the INMARK trial was to investigate changes in neoepitopes as predictors of disease progression in patients with idiopathic pulmonary fibrosis and the effect of nintedanib on these biomarkers. METHODS In this randomised, double-blind, placebo-controlled trial, patients with a diagnosis of idiopathic pulmonary fibrosis within the past 3 years and forced vital capacity (FVC) of 80% predicted or higher were eligible to participate. Patients were recruited from hospitals, private practices, clinical research units, and academic medical centres. Patients were randomly assigned (1:2) with the use of a pseudo-random number generator to receive oral nintedanib 150 mg twice a day or placebo for 12 weeks in a double-blind fashion, followed by open-label nintedanib for 40 weeks. The primary endpoint was the rate of change in C-reactive protein (CRP) degraded by matrix metalloproteinases 1 and 8 (CRPM) from baseline to week 12 in the intention-to-treat population. The trial has been completed and is registered with ClinicalTrials.gov, number NCT02788474, and with the European Clinical Trials Database, number 2015-003148-38. FINDINGS Between June 27, 2016, and May 15, 2017, 347 patients were randomly assigned to the nintedanib group (n=116) or to the placebo group (n=231). One patient from the placebo group was not treated owing to a randomisation error. At baseline, mean FVC was 97·5% (SD 13·5) predicted. In the double-blind period, 116 patients received nintedanib and 230 patients received placebo. The rate of change in CRPM from baseline to week 12 was -2·57 × 10 -3 ng/mL/month in the nintedanib group and -1·90 × 10 -3 ng/mL/month in the placebo group (between-group difference -0·66 × 10 -3 ng/mL/month [95% CI -6·21 × 10 -3 to 4·88 × 10 -3 ]; p=0·8146). The adjusted rate of change in FVC over 12 weeks was 5·9 mL in the nintedanib group and -70·2 mL in the placebo group (difference 76·1 mL/12 weeks [31·7 to 120·4]). In patients who received placebo for 12 weeks followed by open-label nintedanib, rising concentrations of CRPM over 12 weeks were associated with disease progression (absolute decline in FVC ≥10% predicted or death) over 52 weeks. In the double-blind period, serious adverse events were reported in eight (7%) patients given nintedanib and 18 (8%) patients given placebo. Grade 3 diarrhoea was reported in two (2%) patients in the nintedanib group and two (1%) patients in the placebo group. No patients had grade 4 diarrhoea. INTERPRETATION In patients with idiopathic pulmonary fibrosis and preserved lung function, treatment with nintedanib versus placebo for 12 weeks did not affect the rate of change in CRPM but was associated with a reduced rate of decline in FVC. These results suggest that change in CRPM is not a marker of response to nintedanib in patients with idiopathic pulmonary fibrosis. FUNDING Boehringer Ingelheim.",2019,"In the double-blind period, serious adverse events were reported in eight (7%) patients given nintedanib and 18 (8%) patients given placebo.","['Between June 27, 2016, and May 15, 2017, 347 patients were randomly assigned to the nintedanib group (n=116) or to the', 'patients with a diagnosis of idiopathic pulmonary fibrosis within the past 3 years and forced vital capacity (FVC) of 80% predicted or higher were eligible to participate', '116 patients received nintedanib and 230 patients received', 'patients with idiopathic pulmonary fibrosis', 'patients with idiopathic pulmonary fibrosis given nintedanib (INMARK study', 'Patients were recruited from hospitals, private practices, clinical research units, and academic medical centres']","['nintedanib versus placebo', 'placebo', 'oral nintedanib 150 mg twice a day or placebo']","['serious adverse events', 'mean FVC', 'rate of change in C-reactive protein (CRP) degraded by matrix metalloproteinases 1 and 8 (CRPM', 'adjusted rate of change in FVC', 'rate of decline in FVC', 'grade 4 diarrhoea', 'rate of change in CRPM', 'Grade 3 diarrhoea']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C2930789', 'cui_str': 'nintedanib'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0085786', 'cui_str': 'Alveolitis, Fibrosing'}, {'cui': 'C1444637', 'cui_str': 'In the past'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3714541', 'cui_str': 'Forced Vital Capacity'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C4517541', 'cui_str': '116 (qualifier value)'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0033174', 'cui_str': 'Private Practice'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0035168'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0000872', 'cui_str': 'University Medical Centers'}]","[{'cui': 'C2930789', 'cui_str': 'nintedanib'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C3859350', 'cui_str': 'nintedanib 150 MG [Ofev]'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0127082', 'cui_str': 'Interstitial Collagenase'}, {'cui': 'C0054856', 'cui_str': 'CARP (Mytilus)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}]",347.0,0.65144,"In the double-blind period, serious adverse events were reported in eight (7%) patients given nintedanib and 18 (8%) patients given placebo.","[{'ForeName': 'Toby M', 'Initials': 'TM', 'LastName': 'Maher', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, London, UK; National Institute for Health Research Clinical Research Facility, Royal Brompton Hospital, London, UK. Electronic address: t.maher@imperial.ac.uk.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Stowasser', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Rhein, Germany.'}, {'ForeName': 'Yasuhiko', 'Initials': 'Y', 'LastName': 'Nishioka', 'Affiliation': 'Graduate School of Biomedical Sciences, Tokushima University, Tokushima, Japan.'}, {'ForeName': 'Eric S', 'Initials': 'ES', 'LastName': 'White', 'Affiliation': 'University of Michigan, Division of Pulmonary and Critical Care Medicine, Ann Arbor, MI, USA.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Cottin', 'Affiliation': 'National Reference Centre for Rare Pulmonary Diseases, Louis Pradel Hospital, Hospices Civils de Lyon, Claude Bernard University Lyon 1, Lyon, France.'}, {'ForeName': 'Imre', 'Initials': 'I', 'LastName': 'Noth', 'Affiliation': 'Division of Pulmonary and Critical Care Medicine, University of Virginia, Charlottesville, VI, USA.'}, {'ForeName': 'Moisés', 'Initials': 'M', 'LastName': 'Selman', 'Affiliation': 'Instituto Nacional de Enfermedades Respiratorias Ismael Cosio Villegas, Mexico City, Mexico.'}, {'ForeName': 'Klaus B', 'Initials': 'KB', 'LastName': 'Rohr', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Rhein, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Michael', 'Affiliation': 'Syneos Health, Farnborough, UK.'}, {'ForeName': 'Carina', 'Initials': 'C', 'LastName': 'Ittrich', 'Affiliation': 'Boehringer Ingelheim Pharma GmbH & Co KG, Biberach an der Riss, Germany.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Diefenbach', 'Affiliation': 'Boehringer Ingelheim Pharma GmbH & Co KG, Biberach an der Riss, Germany.'}, {'ForeName': 'R Gisli', 'Initials': 'RG', 'LastName': 'Jenkins', 'Affiliation': 'National Institute for Health Research Respiratory Biomedical Research Centre, City Campus, Nottingham University Hospital, Nottingham, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Respiratory medicine,['10.1016/S2213-2600(19)30255-3'] 910,31253237,Smoking Cessation among Female and Male Veterans before and after a Randomized Trial of Proactive Outreach.,"INTRODUCTION Female veterans smoke cigarettes at high rates compared with both male veterans and nonveteran women. Proactive outreach to smokers may reduce gender disparities in cessation care. The objectives of this study were to compare baseline experiences with VA smoking cessation care for men and women and to assess for gender differences in response to a proactive outreach intervention. METHODS We conducted a post hoc subgroup analysis of a pragmatic, multisite randomized, controlled trial comparing proactive outreach with usual care (UC). Baseline experiences included physician advice to quit, satisfaction with care, and past-year treatment use. At the 1-year follow-up, treatment use, quit attempts, and 6-month prolonged abstinence for women and men randomized to proactive outreach versus UC were compared using logistic regression. RESULTS Baseline and follow-up surveys were returned by 138 women and 2,516 men. At baseline, women were less likely than men to report being very or somewhat satisfied with the process of obtaining smoking cessation medications in the VA (47% of women vs. 62% of men), but no less likely to report having used cessation medications from the VA in the past year (39% of women vs. 34% of men). After the intervention, phone counseling and combined therapy increased among both women and men in proactive outreach as compared with UC. At the 1-year follow-up, men in proactive outreach were significantly more likely to report prolonged abstinence than those in UC (odds ratio, 1.65; 95% CI, 1.28-2.14); results for women were in the same direction but not statistically significant (odds ratio, 1.39; 95% CI, 0.48-3.99). CONCLUSIONS Satisfaction with cessation care in VA remains low. Proactive outreach to smokers was associated with an increased use of cessation therapies, and increased odds of achieving prolonged abstinence. A subgroup analysis by gender did not reveal significant differences in the treatment effect.",2019,"At baseline, women were less likely than men to report being very or somewhat satisfied with the process of obtaining smoking cessation medications in the VA (47% of women vs. 62% of men), but no less likely to report having used cessation medications from the VA in the past year (39% of women vs. 34% of men).","['Female and Male Veterans', '138 women and 2,516 men', 'Female veterans smoke cigarettes at high rates compared with both male veterans and nonveteran women']","['phone counseling and combined therapy', 'VA smoking cessation care', 'proactive outreach versus UC', 'proactive outreach with usual care (UC']","['physician advice to quit, satisfaction with care, and past-year treatment use', 'Smoking Cessation']","[{'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]","[{'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0033972', 'cui_str': 'Psychotherapy, Multiple'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}]","[{'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to (procedure)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C1444637', 'cui_str': 'In the past'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}]",,0.115001,"At baseline, women were less likely than men to report being very or somewhat satisfied with the process of obtaining smoking cessation medications in the VA (47% of women vs. 62% of men), but no less likely to report having used cessation medications from the VA in the past year (39% of women vs. 34% of men).","[{'ForeName': 'Elisheva R', 'Initials': 'ER', 'LastName': 'Danan', 'Affiliation': 'VA HSR&D Center for Care Delivery and Outcomes Research, Minneapolis VA Health Care System, Minneapolis, Minnesota; Department of Medicine, University of Minnesota Medical School, Minneapolis, Minnesota. Electronic address: elizabeth.danan@va.gov.'}, {'ForeName': 'Scott E', 'Initials': 'SE', 'LastName': 'Sherman', 'Affiliation': 'Department of Medicine, VA New York Harbor Healthcare System, New York, New York; Department of Population Health, New York University School of Medicine, New York, New York.'}, {'ForeName': 'Barbara A', 'Initials': 'BA', 'LastName': 'Clothier', 'Affiliation': 'VA HSR&D Center for Care Delivery and Outcomes Research, Minneapolis VA Health Care System, Minneapolis, Minnesota.'}, {'ForeName': 'Diana J', 'Initials': 'DJ', 'LastName': 'Burgess', 'Affiliation': 'VA HSR&D Center for Care Delivery and Outcomes Research, Minneapolis VA Health Care System, Minneapolis, Minnesota; Department of Medicine, University of Minnesota Medical School, Minneapolis, Minnesota.'}, {'ForeName': 'Erika A', 'Initials': 'EA', 'LastName': 'Pinsker', 'Affiliation': 'VA HSR&D Center for Care Delivery and Outcomes Research, Minneapolis VA Health Care System, Minneapolis, Minnesota.'}, {'ForeName': 'Anne M', 'Initials': 'AM', 'LastName': 'Joseph', 'Affiliation': 'Department of Medicine, University of Minnesota Medical School, Minneapolis, Minnesota.'}, {'ForeName': 'Siamak', 'Initials': 'S', 'LastName': 'Noorbaloochi', 'Affiliation': 'VA HSR&D Center for Care Delivery and Outcomes Research, Minneapolis VA Health Care System, Minneapolis, Minnesota; Department of Medicine, University of Minnesota Medical School, Minneapolis, Minnesota.'}, {'ForeName': 'Steven S', 'Initials': 'SS', 'LastName': 'Fu', 'Affiliation': 'VA HSR&D Center for Care Delivery and Outcomes Research, Minneapolis VA Health Care System, Minneapolis, Minnesota; Department of Medicine, University of Minnesota Medical School, Minneapolis, Minnesota.'}]",Women's health issues : official publication of the Jacobs Institute of Women's Health,['10.1016/j.whi.2019.04.001'] 911,31104167,Influence of genetic variation in the vitamin D pathway on plasma 25-hydroxyvitamin D 3 levels and survival among patients with metastatic colorectal cancer.,"PURPOSE The relationships of genetic variation in the vitamin D pathway with circulating 25-hydroxyvitamin D 3 [25(OH)D] levels and survival remain largely unknown for patients with metastatic colorectal cancer (mCRC). METHODS Among 535 patients participating in a randomized trial of chemotherapy for mCRC, we prospectively measured baseline plasma 25(OH)D and examined 124 tagging single-nucleotide polymorphisms (SNPs) within seven genes in the vitamin D pathway, including five SNPs associated with circulating 25(OH)D levels in previous genome-wide association studies (GWAS). We evaluated whether these SNPs were associated with plasma 25(OH)D levels and patient outcome (overall survival, time to progression, and tumor response), using linear, logistic, and Cox proportional hazards regression. RESULTS We observed a significant association between 25(OH)D levels and an additive genetic risk score determined by the five GWAS-identified SNPs (p = 0.0009). We did not observe any direct association between 25(OH)D-associated SNPs, individually or as a genetic risk score, and patient outcome. However, we found a significant interaction between 25(OH)D levels and rs12785878 genotype in DHCR7 on overall survival (p interaction  = 0.02). CONCLUSION Germline genetic variation in the vitamin D pathway informs baseline 25(OH)D levels among patients with mCRC. The association between 25(OH)D levels and overall survival may vary by DHCR7 genotype. ClinicalTrials.gov Identifier: NCT00003594 ( https://clinicaltrials.gov/ct2/show/NCT00003594 ).",2019,"We did not observe any direct association between 25(OH)D-associated SNPs, individually or as a genetic risk score, and patient outcome.","['patients with mCRC', 'patients with metastatic colorectal cancer (mCRC', '535 patients participating in a randomized trial of chemotherapy for mCRC, we prospectively measured baseline plasma 25(OH)D and examined 124 tagging single-nucleotide polymorphisms (SNPs) within seven genes in the vitamin D pathway, including five SNPs associated with circulating 25(OH)D levels in previous genome-wide association studies (GWAS', 'patients with metastatic colorectal cancer']",[],"['plasma 25(OH)D levels and patient outcome (overall survival, time to progression, and tumor response', '25(OH)D levels and overall survival', 'overall survival', '25(OH)D levels and an additive genetic risk score']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0346973', 'cui_str': 'Secondary malignant neoplasm of large intestine'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C4517553', 'cui_str': '124 (qualifier value)'}, {'cui': 'C0037293', 'cui_str': 'Tag (morphologic abnormality)'}, {'cui': 'C0752046', 'cui_str': 'Single Nucleotide Polymorphism'}, {'cui': 'C0332285', 'cui_str': 'In (attribute)'}, {'cui': 'C0017337', 'cui_str': 'Genes'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1533153', 'cui_str': 'Fives'}, {'cui': 'C0332281', 'cui_str': 'Associated with (attribute)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C2350277', 'cui_str': 'GWA Study'}]",[],"[{'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0442796', 'cui_str': 'Additive (qualifier value)'}, {'cui': 'C0017399', 'cui_str': 'genetics'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",535.0,0.0457817,"We did not observe any direct association between 25(OH)D-associated SNPs, individually or as a genetic risk score, and patient outcome.","[{'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Yuan', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute and Harvard Medical School, 450 Brookline Ave, Boston, MA, 02215, USA. chen_yuan@dfci.harvard.edu.'}, {'ForeName': 'Lindsay', 'Initials': 'L', 'LastName': 'Renfro', 'Affiliation': 'Division of Biomedical Statistics and Informatics, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Pratibha B', 'Initials': 'PB', 'LastName': 'Ambadwar', 'Affiliation': 'Division of Biomedical Statistics and Informatics, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Fang-Shu', 'Initials': 'FS', 'LastName': 'Ou', 'Affiliation': 'Alliance Statistics and Data Center, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Howard L', 'Initials': 'HL', 'LastName': 'McLeod', 'Affiliation': 'DeBartolo Family Personalized Medicine Institute, Moffitt Cancer Center, Tampa, FL, USA.'}, {'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Innocenti', 'Affiliation': 'Eshelman School of Pharmacy and Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Jeffrey A', 'Initials': 'JA', 'LastName': 'Meyerhardt', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute and Harvard Medical School, 450 Brookline Ave, Boston, MA, 02215, USA.'}, {'ForeName': 'Brian M', 'Initials': 'BM', 'LastName': 'Wolpin', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute and Harvard Medical School, 450 Brookline Ave, Boston, MA, 02215, USA.'}, {'ForeName': 'Richard M', 'Initials': 'RM', 'LastName': 'Goldberg', 'Affiliation': 'West Virginia University Cancer Institute, Morgantown, WV, USA.'}, {'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Grothey', 'Affiliation': 'Division of Medical Oncology, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Charles S', 'Initials': 'CS', 'LastName': 'Fuchs', 'Affiliation': 'Yale Cancer Center and Smilow Cancer Hospital, New Haven, CT, USA.'}, {'ForeName': 'Kimmie', 'Initials': 'K', 'LastName': 'Ng', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute and Harvard Medical School, 450 Brookline Ave, Boston, MA, 02215, USA.'}]",Cancer causes & control : CCC,['10.1007/s10552-019-01183-1'] 912,31325345,Randomized controlled trial of the effectiveness of three different oral moisturizers in palliative care patients.,"Most patients in palliative care have problems with dry mouth caused by medication or as a direct result of their condition. Dry mouth may cause problems that affect the primary disease negatively and contribute to poorer quality of life in palliative patients. This randomized controlled trial compared the efficacy of three different oral moisturizers: 17% watery solution of glycerol; oxygenated glycerol triester (marketed as Aequasyal in Europe and as Aquoral in the USA); and a newly developed product, Salient. Of the three products, glycerol provided the best relief from xerostomia directly after application, but had no effect after 2 h. By contrast, the effects of Aequasyal and Salient were largely maintained over the same period. The findings for oral discomfort and pain and speech problems showed a similar pattern. Despite its poor effect after 2 h, patients preferred glycerol over Salient and Aequasyal, probably because of the unpleasant taste of Aequasyal and the consistency and mode of application of Salient. Within the limitations of this study, none of the three products tested was found to be clinically completely adequate. However, the glycerol solution was preferred by this group of patients, and its short-lived effect can be compensated for by frequent applications.",2019,"Of the three products, glycerol provided the best relief from xerostomia directly after application, but had no effect after 2 h.","['palliative patients', 'palliative care patients']",['oral moisturizers: 17% watery solution of glycerol; oxygenated glycerol triester'],['oral discomfort and pain and speech problems'],"[{'cui': 'C1285530', 'cui_str': 'Palliative'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0700049', 'cui_str': 'Palliative care'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0443350', 'cui_str': 'Watery (finding)'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}, {'cui': 'C0017861', 'cui_str': 'Glycerin'}]","[{'cui': 'C0399459', 'cui_str': 'Discomfort in mouth (finding)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0395016', 'cui_str': 'Speech problem (finding)'}]",,0.053966,"Of the three products, glycerol provided the best relief from xerostomia directly after application, but had no effect after 2 h.","[{'ForeName': 'Siri F', 'Initials': 'SF', 'LastName': 'Kvalheim', 'Affiliation': 'Department of Clinical Dentistry, Faculty of Medicine, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Mihaela C', 'Initials': 'MC', 'LastName': 'Marthinussen', 'Affiliation': 'Department of Clinical Dentistry, Faculty of Medicine, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Dagny F', 'Initials': 'DF', 'LastName': 'Haugen', 'Affiliation': 'Department of Clinical Medicine K1, Faculty of Medicine, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Einar', 'Initials': 'E', 'LastName': 'Berg', 'Affiliation': 'Department of Clinical Dentistry, Faculty of Medicine, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Gunhild V', 'Initials': 'GV', 'LastName': 'Strand', 'Affiliation': 'Department of Clinical Dentistry, Faculty of Medicine, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Stein-Atle', 'Initials': 'SA', 'LastName': 'Lie', 'Affiliation': 'Department of Clinical Dentistry, Faculty of Medicine, University of Bergen, Bergen, Norway.'}]",European journal of oral sciences,['10.1111/eos.12655'] 913,30487561,Wine and Health-New Evidence.,"Health benefits of moderate wine consumption have been studied during the past decades, first in observational studies and more recently, in experimental settings and randomized controlled studies. Suggested biological pathways include antioxidant, lipid regulating, and anti-inflammatory effects. Both the alcoholic and polyphenolic components of wine are believed to contribute to these beneficial effects. Although several of these studies demonstrated protective associations between moderate drinking and cardiovascular disease, atherosclerosis, hypertension, certain types of cancer, type 2 diabetes, neurological disorders, and the metabolic syndrome, no conclusive recommendations exist regarding moderate wine consumption. Yet, it is suggested that the physician and patient should discuss alcohol use. In the CASCADE (CArdiovaSCulAr Diabetes & Ethanol) trial, 224 abstainers with type 2 diabetes were randomized to consume red wine, white wine or mineral water for two years. Here, we summarize our previous findings, offer new evidence concerning the differential effects of wine consumption among men and women, and further suggest that initiating moderate alcohol consumption among well-controlled persons with type 2 diabetes is apparently safe, in regard to changes in heart rate variability and carotid plaque formation.",2019,"In the CASCADE (CArdiovaSCulAr Diabetes & Ethanol) trial, 224 abstainers with type 2 diabetes were randomized to consume red wine, white wine or mineral water for two years.","['men and women', '224 abstainers with type 2 diabetes']","['consume red wine, white wine or mineral water for two years']",[],"[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C4319560', 'cui_str': '224'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0349371', 'cui_str': 'Red wine (substance)'}, {'cui': 'C0349372', 'cui_str': 'White wine (substance)'}, {'cui': 'C0026157', 'cui_str': 'Mineral Waters'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]",[],224.0,0.0261421,"In the CASCADE (CArdiovaSCulAr Diabetes & Ethanol) trial, 224 abstainers with type 2 diabetes were randomized to consume red wine, white wine or mineral water for two years.","[{'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Golan', 'Affiliation': 'Ben-Gurion University of the Negev, Beer Sheva, Israel. golanra@bgu.ac.il.'}, {'ForeName': 'Yftach', 'Initials': 'Y', 'LastName': 'Gepner', 'Affiliation': 'Ben-Gurion University of the Negev, Beer Sheva, Israel.'}, {'ForeName': 'Iris', 'Initials': 'I', 'LastName': 'Shai', 'Affiliation': 'Ben-Gurion University of the Negev, Beer Sheva, Israel.'}]",European journal of clinical nutrition,['10.1038/s41430-018-0309-5'] 914,31315471,Economic evaluation of prolonged and enhanced ECG Holter monitoring in acute ischemic stroke patients.,"Objective: Atrial fibrillation (AF) is a major cause for recurrent stroke, has severe impact on a patient's health and imposes a high economic burden for society. Current guidelines recommend 24 h ECG monitoring (standard-of-care, SoC) to detect AF after stroke to reduce the risk of future events. However, paroxysmal AF (PAF) is difficult to detect within this period as it occurs infrequently and unpredictably. In a randomized controlled trial (Find-AF RANDOMISED ), prolonged and enhanced Holter ECG monitoring (EPM) revealed a significantly higher detection rate of AF compared to SoC, although its cost-effectiveness has not yet been investigated. Methods: Based on the data of FIND-AF RANDOMISED , an economic evaluation was conducted. One group received EPM for 10 days after the event, and at 3 and 6 months; the other group received SoC. Healthcare resource use and quality of life (QoL) data were measured at baseline, and after 6 and 12 months. Incremental costs and quality-adjusted life years (QALYs) between both groups were compared. Non-parametric bootstrapping and one-way-sensitivity analyses were performed. Results: A total of 281 patients with healthcare resource use and QoL data for all measurement points were considered in the economic evaluation (complete case analysis, CCA). The CCA yielded nonsignificant 315€ lower mean costs and 0.0013 less QALYs for patients receiving EPM with no statistically significant differences in any cost categories. Sensitivity analyses revealed robust results. Bootstrapping the results indicated moderate probability of cost-effectiveness. Conclusions: EPM yielded reduced not significantly different costs without affecting QoL and may be a useful strategy to detect PAF in acute ischemic stroke patients in time.",2019,yielded reduced not significantly different costs without affecting QoL and may be a useful strategy to detect PAF in acute ischemic stroke patients in time.,"['acute ischemic stroke patients', '281 patients with healthcare resource', 'acute ischemic stroke patients in time']","['Holter ECG monitoring (EPM', 'prolonged and enhanced ECG Holter monitoring', 'EPM', 'Atrial fibrillation (AF']","['quality of life (QoL) data', 'moderate probability of cost-effectiveness', 'Incremental costs and quality-adjusted life years (QALYs']","[{'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C1632851', 'cui_str': 'Times'}]","[{'cui': 'C0180580', 'cui_str': 'Electrocardiographic monitoring'}, {'cui': 'C0439590', 'cui_str': 'Prolonged (qualifier value)'}, {'cui': 'C1623258', 'cui_str': 'ECG'}, {'cui': 'C0013801', 'cui_str': 'Monitoring, Holter'}, {'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}]","[{'cui': 'C0034380'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0080071', 'cui_str': 'QALY'}]",281.0,0.097969,yielded reduced not significantly different costs without affecting QoL and may be a useful strategy to detect PAF in acute ischemic stroke patients in time.,"[{'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Diekmann', 'Affiliation': 'Institute for Health Care Management and Research, University of Duisburg-Essen , Essen , Germany.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Hörster', 'Affiliation': 'Institute for Health Care Management and Research, University of Duisburg-Essen , Essen , Germany.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Evers', 'Affiliation': 'Faculty of Health, Medicine and Life Sciences, Department of Health Services Research, CAPHRI Care and Public Health Research Institute, Maastricht University , Maastricht , The Netherlands.'}, {'ForeName': 'Mickaël', 'Initials': 'M', 'LastName': 'Hiligsmann', 'Affiliation': 'Faculty of Health, Medicine and Life Sciences, Department of Health Services Research, CAPHRI Care and Public Health Research Institute, Maastricht University , Maastricht , The Netherlands.'}, {'ForeName': 'Götz', 'Initials': 'G', 'LastName': 'Gelbrich', 'Affiliation': 'Institute for Clinical Epidemiology and Biometry, University of Würzburg , Würzburg , Germany.'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Gröschel', 'Affiliation': 'Department of Neurology, University Medical Centre of Johannes Gutenberg University Mainz , Mainz , Germany.'}, {'ForeName': 'Rolf', 'Initials': 'R', 'LastName': 'Wachter', 'Affiliation': 'Clinic for Cardiology and Pneumology, University of Göttingen , Göttingen , Germany.'}, {'ForeName': 'Gerhard F', 'Initials': 'GF', 'LastName': 'Hamann', 'Affiliation': 'Clinic for Neurology and Neurological Rehabilitation, Bezirkskrankenhaus Günzburg , Günzburg , Germany.'}, {'ForeName': 'Pawel', 'Initials': 'P', 'LastName': 'Kermer', 'Affiliation': 'Clinic for Neurology, Hospital Nordwest-Krankenhaus Sanderbusch , Sande , Germany.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Liman', 'Affiliation': 'Clinic for Neurology, University of Göttingen , Göttingen , Germany.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Weber-Krüger', 'Affiliation': 'Clinic for Cardiology and Pneumology, University of Göttingen , Göttingen , Germany.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Wasem', 'Affiliation': 'Institute for Health Care Management and Research, University of Duisburg-Essen , Essen , Germany.'}, {'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'Neumann', 'Affiliation': 'Institute for Health Care Management and Research, University of Duisburg-Essen , Essen , Germany.'}]",Current medical research and opinion,['10.1080/03007995.2019.1646000'] 915,32208038,A patient-level cost-effectiveness analysis of iron isomaltoside versus ferric carboxymaltose for the treatment of iron deficiency anemia in the United Kingdom.,"Objectives: Intravenous iron is the recommended treatment for patients with iron deficiency anemia (IDA) where oral iron is ineffective or rapid iron replenishment is required. Two high-dose, rapid-administration intravenous iron formulations are currently available in the UK: iron isomaltoside 1000/ferric derisomaltose (IIM) and ferric carboxymaltose (FCM). An indirect treatment comparison (ITC) recently showed that improvement from baseline hemoglobin was significantly larger with IIM than FCM. The objective was to use the ITC findings to evaluate the cost-effectiveness of IIM versus FCM from the UK healthcare payer perspective. Methods: A patient-level simulation model was developed in R to evaluate the cost per patient experiencing hematological response with IIM versus FCM. The model generated a simulated cohort from parametric distributions of baseline hemoglobin and bodyweight. Changes in hemoglobin were modeled based on data from the ITC, covaried with baseline hemoglobin based on patient-level data from a randomized controlled trial. Posological models of the iron formulations were developed based on the summaries of product characteristics. UK-specific costs were based on healthcare resource groups. Results: The proportion of patients experiencing hematological response was 9.0% higher with IIM relative to FCM (79.0% versus 70.0%), based on modeling of clinically realistic, correlated distributions of baseline hemoglobin and change from baseline hemoglobin. The mean number of infusions needed to administer the required dose was 1.92 with FCM, versus 1.38 with IIM, resulting in costs of £637 and £457 per treated patient with FCM and IIM respectively, corresponding to respective costs of £910 and £579 per responder. Conclusions: The analysis showed that using IIM rather than FCM in patients with IDA was dominant and would reduce the number of iron infusions required to correct iron deficiency, thereby reducing the costs associated with IDA treatment and simultaneously increasing the proportion of patients with IDA experiencing a clinically meaningful hematological response.",2020,"The proportion of patients experiencing hematological response was 9.0% higher with IIM relative to FCM (79.0% versus 70.0%), based on modeling of realistic, correlated distributions of baseline hemoglobin and change in hemoglobin.","['iron deficiency anemia in the United Kingdom', 'patients with IDA', 'patients with iron deficiency anemia (IDA']","['iron isomaltoside versus ferric carboxymaltose', 'FCM']","['mean number of infusions needed to administer the required dose', 'proportion of patients experiencing hematological response']","[{'cui': 'C0162316', 'cui_str': 'Iron deficiency anemia (disorder)'}, {'cui': 'C0041700', 'cui_str': 'United Kingdom'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0337439', 'cui_str': 'Iron measurement (procedure)'}, {'cui': 'C2001867', 'cui_str': 'ferric carboxymaltose'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]",2.0,0.0782688,"The proportion of patients experiencing hematological response was 9.0% higher with IIM relative to FCM (79.0% versus 70.0%), based on modeling of realistic, correlated distributions of baseline hemoglobin and change in hemoglobin.","[{'ForeName': 'Richard F', 'Initials': 'RF', 'LastName': 'Pollock', 'Affiliation': 'Covalence Research Ltd, London, UK.'}, {'ForeName': 'Gorden', 'Initials': 'G', 'LastName': 'Muduma', 'Affiliation': 'Pharmacosmos A/S, Holbaek, Denmark.'}]",Journal of medical economics,['10.1080/13696998.2020.1745535'] 916,32145129,Reduction and stabilization of bilirubin with obeticholic acid treatment in patients with primary biliary cholangitis.,"BACKGROUND & AIMS Total bilirubin is a predictor of survival in primary biliary cholangitis, with the main elevated component being direct bilirubin. The purpose of this post hoc analysis was to assess the efficacy and safety of obeticholic acid across quartiles of varying baseline levels of direct bilirubin in the phase 3, randomized, placebo-controlled Primary Biliary Cholangitis Obeticholic Acid International Study of Efficacy. METHODS This analysis assessed patients on the basis of their baseline direct bilirubin level (divided by quartile). Biochemistry and safety outcomes were evaluated within each quartile over time. RESULTS In the quartile with the highest baseline direct bilirubin (>5.47 µmol/L), there was a significant reduction in both direct and total bilirubin at Month 12 compared with placebo. Least squares mean (standard error) change from baseline in direct bilirubin at Month 12 was 4.17 (1.42) µmol/L for placebo, -3.48 (1.63) µmol/L for obeticholic acid 5-10 mg and -3.66 (1.51) µmol/L for obeticholic acid 10 mg (P < .0001, obeticholic acid vs placebo); the corresponding values for total bilirubin at Month 12 were 4.38 (1.55) µmol/L for placebo, -4.53 (1.83) µmol/L for obeticholic acid 5-10 mg and -5.06 (1.64) µmol/L for obeticholic acid 10 mg (P < .0001, obeticholic acid vs placebo). CONCLUSIONS Obeticholic acid treatment was associated with significant reductions in total and direct bilirubin, particularly in patients with high baseline direct bilirubin. Because raised direct bilirubin levels, even within the normal range, are predictive of survival in primary biliary cholangitis, these results suggest substantial benefits of obeticholic acid in at-risk patients.",2020,"< .0001, obeticholic acid vs placebo); the corresponding values for total bilirubin at Month 12 were 4.38 (1.55) µmol/L for placebo, -4.53 (1.83) µmol/L for obeticholic acid","['patients with primary biliary cholangitis', 'patients with high baseline direct bilirubin']","['obeticholic acid', 'bilirubin with obeticholic acid treatment', 'Obeticholic acid', 'placebo', 'obeticholic acid vs placebo']","['total and direct bilirubin', 'Biochemistry and safety outcomes', 'highest baseline direct bilirubin', 'direct and total bilirubin', 'total bilirubin']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0008312', 'cui_str': 'Primary Billiary Cholangitis'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0236556', 'cui_str': 'Direct reacting bilirubin (substance)'}]","[{'cui': 'C1143018', 'cui_str': 'obeticholic acid'}, {'cui': 'C0005437', 'cui_str': 'Bilirubin IX alpha'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0236556', 'cui_str': 'Direct reacting bilirubin (substance)'}, {'cui': 'C0005477', 'cui_str': 'Biochemistry'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C0201913', 'cui_str': 'Bilirubin, total measurement (procedure)'}]",,0.402476,"< .0001, obeticholic acid vs placebo); the corresponding values for total bilirubin at Month 12 were 4.38 (1.55) µmol/L for placebo, -4.53 (1.83) µmol/L for obeticholic acid","[{'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Parés', 'Affiliation': 'Hospital Clinic, University of Barcelona, IDIBAPS, CIBERehd, Barcelona, Spain.'}, {'ForeName': 'Mitchell', 'Initials': 'M', 'LastName': 'Shiffman', 'Affiliation': 'Liver Institute of Virginia, Bon Secours Mercy Health, Newport News, VA, USA.'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Vargas', 'Affiliation': ""Liver Unit, Hospital Vall d'Hebron, Universitat Autònoma de Barcelona, CIBERehd, Barcelona, Spain.""}, {'ForeName': 'Pietro', 'Initials': 'P', 'LastName': 'Invernizzi', 'Affiliation': 'Division of Gastroenterology and Center for Autoimmune Liver Diseases, San Gerardo Hospital, Department of Medicine and Surgery, University of Milano-Bicocca, Monza, Italy.'}, {'ForeName': 'Elizabeth S', 'Initials': 'ES', 'LastName': 'Malecha', 'Affiliation': 'Intercept Pharmaceuticals, San Diego, CA, USA.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Liberman', 'Affiliation': 'Intercept Pharmaceuticals, San Diego, CA, USA.'}, {'ForeName': 'Leigh', 'Initials': 'L', 'LastName': 'MacConell', 'Affiliation': 'Intercept Pharmaceuticals, San Diego, CA, USA.'}, {'ForeName': 'Gideon', 'Initials': 'G', 'LastName': 'Hirschfield', 'Affiliation': 'Toronto Centre for Liver Disease, Toronto General Hospital and Department of Medicine, University of Toronto, Toronto, Canada.'}]",Liver international : official journal of the International Association for the Study of the Liver,['10.1111/liv.14429'] 917,32161366,Oxytocin induces long-lasting adaptations within amygdala circuitry in autism: a treatment-mechanism study with randomized placebo-controlled design.,"Intranasal administration of the neuropeptide oxytocin (IN-OT) is increasingly explored as a potential treatment for targeting the core symptoms of autism spectrum disorder (ASD). To date, however, the impact of multiple-dose IN-OT treatment on human neural circuitry is largely unknown, and also the possibility that long-term IN-OT use may induce long-lasting neural adaptations remains unexplored. Using a double-blind, randomized, placebo-controlled, between-subject design (including 38 adult men with ASD), this treatment-mechanism study showed that 4 weeks of daily oxytocin administration (24 IU/day) significantly altered intrinsic (resting-state fMRI) functional connectivity of the amygdala to core regions of the ""social brain"" (particularly orbitofrontal cortex and superior temporal sulcus) up to 4 weeks and 1 year post treatment. The neural adaptations in functional coupling of the amygdala to the orbitofrontal cortex were associated with reduced feelings of avoidance toward others and-at the trend level-reduced repetitive behaviors. These observations contribute to a deeper mechanistic understanding of the neural substrates that underlie behavioral effects of multiple-dose IN-OT treatment, and provide initial insights into the long-lasting neural consequences of chronic IN-OT use on amygdala circuitry. Future studies are however warranted to further elucidate the long-term impact of IN-OT treatment on human neural circuitry and its behavioral consequences.",2020,The neural adaptations in functional coupling of the amygdala to the orbitofrontal cortex were associated with reduced feelings of avoidance toward others and-at the trend level-reduced repetitive behaviors.,"['38 adult men with ASD', 'autism']","['neuropeptide oxytocin (IN-OT', 'oxytocin', 'Oxytocin', 'placebo']","['altered intrinsic (resting-state fMRI) functional connectivity of the amygdala to core regions of the ""social brain"" (particularly orbitofrontal cortex and superior temporal sulcus']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0004352', 'cui_str': 'Autism, Early Infantile'}]","[{'cui': 'C0027895', 'cui_str': 'Neuropeptides'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0439674', 'cui_str': 'Intrinsic (qualifier value)'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0376335', 'cui_str': 'fMRI'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0002708', 'cui_str': 'Amygdaloid Body'}, {'cui': 'C0444669', 'cui_str': 'Core (qualifier value)'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C2331062', 'cui_str': 'Orbital Area'}, {'cui': 'C0228237', 'cui_str': 'Structure of superior temporal sulcus'}]",38.0,0.130252,The neural adaptations in functional coupling of the amygdala to the orbitofrontal cortex were associated with reduced feelings of avoidance toward others and-at the trend level-reduced repetitive behaviors.,"[{'ForeName': 'Kaat', 'Initials': 'K', 'LastName': 'Alaerts', 'Affiliation': 'Department of Rehabilitation Sciences, Group Biomedical Sciences, Neurorehabilitation Research Group, University of Leuven, KU Leuven, Belgium. Kaat.Alaerts@kuleuven.be.'}, {'ForeName': 'Sylvie', 'Initials': 'S', 'LastName': 'Bernaerts', 'Affiliation': 'Department of Rehabilitation Sciences, Group Biomedical Sciences, Neurorehabilitation Research Group, University of Leuven, KU Leuven, Belgium.'}, {'ForeName': 'Jellina', 'Initials': 'J', 'LastName': 'Prinsen', 'Affiliation': 'Department of Rehabilitation Sciences, Group Biomedical Sciences, Neurorehabilitation Research Group, University of Leuven, KU Leuven, Belgium.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Dillen', 'Affiliation': 'Department of Rehabilitation Sciences, Group Biomedical Sciences, Neurorehabilitation Research Group, University of Leuven, KU Leuven, Belgium.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Steyaert', 'Affiliation': 'Department of Neurosciences, Group Biomedical Sciences, Psychiatry Research Group, University of Leuven, KU Leuven, Belgium.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Wenderoth', 'Affiliation': 'Department of Health Sciences and Technology, Neural Control of Movement Lab, ETH Zurich, Zurich, Switzerland.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-020-0653-8'] 918,31319398,A Group Dynamics-Based Exercise Intervention to Improve Physical Activity Maintenance in Breast Cancer Survivors.,"BACKGROUND To maintain increases in physical activity (PA), interventions that implement group dynamics principles and strategies with the intent of enhancing group cohesion may be advantageous. This study examined group cohesion and PA following a group dynamics-based PA intervention among breast cancer survivors. METHODS The study was designed as a pilot randomized controlled trial comparing an 8-week group dynamics-based intervention with an individually supervised intervention. Group cohesion was measured by the Physical Activity Group Environment Questionnaire, and PA was measured at baseline, post-intervention, and 3-month follow-up using a self-report questionnaire and pedometer. RESULTS Group cohesion levels were high following the intervention and positively associated with PA at 3-month follow-up (ranger = .182-.555). At 3-month follow-up, 91.7% of participants in the group-dynamics-based intervention (n = 12) were classified as moderately active or greater, compared with 54.5% in the individually supervised intervention (n = 11). CONCLUSIONS These results suggest that, for breast cancer survivors, peer support and fostering group cohesion as part of an exercise program may help to support PA following the completion of a structured intervention. A larger trial with longer follow-up is needed to establish comparative efficacy for a group-dynamics-based exercise intervention to enhance long-term PA adherence in breast cancer survivors.",2019,"RESULTS Group cohesion levels were high following the intervention and positively associated with PA at 3-month follow-up (ranger = .182-.555).","['breast cancer survivors', 'Breast Cancer Survivors']","['Exercise Intervention', 'exercise intervention', 'PA following a group dynamics-based PA intervention']","['Physical Activity Group Environment Questionnaire, and PA', 'Physical Activity Maintenance']","[{'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}]",,0.0254624,"RESULTS Group cohesion levels were high following the intervention and positively associated with PA at 3-month follow-up (ranger = .182-.555).","[{'ForeName': 'Heather J', 'Initials': 'HJ', 'LastName': 'Leach', 'Affiliation': ''}, {'ForeName': 'Katie B', 'Initials': 'KB', 'LastName': 'Potter', 'Affiliation': ''}, {'ForeName': 'Mary C', 'Initials': 'MC', 'LastName': 'Hidde', 'Affiliation': ''}]",Journal of physical activity & health,['10.1123/jpah.2018-0667'] 919,31982477,"The impact of front-of-package claims, fruit images, and health warnings on consumers' perceptions of sugar-sweetened fruit drinks: Three randomized experiments.","We aimed to examine the impact of claims, fruit images, and health warnings on consumers' perceptions of fruit-flavored drinks with added sugar (i.e., ""fruit drinks""). We conducted three 2x2x2 randomized experiments with online convenience samples of U.S. adults (Study 1 n = 2139 in 2018, current e-cigarette users and smokers; Study 2 n = 670 in 2018, current e-cigarette users; Study 3 n = 1006 in 2019, general sample). Participants viewed a fruit drink that differed in the presence of a ""100% Vitamin C"" claim, a fruit image, or a health warning. On average across the three studies, consumers who saw a claim on a fruit drink believed that the drink was more healthful than those who did not see the claim (mean average differential effect (ADE) = 0.66, p < .001); they were also more interested in consuming the drink (mean ADE = 0.38, p = .001). The health warning decreased perceived product healthfulness (mean ADE = -0.65, p < .001) and consumption interest (mean ADE = -0.49, p < .001). The fruit image had no effect on perceived product healthfulness (mean ADE = 0.03, p = .81) or purchase intentions (mean ADE = -0.04, p = .77). In Study 1 and Study 2, there were no interactions between claims, images, or warnings (all p > .05). In Study 3, the ""100% Vitamin C"" nutrition claim only increased perceived product healthfulness when the drink did not also have a health warning (interaction p < .05). These findings suggest that 100% Vitamin C claims increase the appeal of fruit drinks, whereas health warnings decrease the appeal. Together, these studies support policies to restrict marketing and require health warnings on sugar-sweetened beverage packaging.",2020,"The fruit image had no effect on perceived product healthfulness (mean ADE = 0.03, p = .81) or purchase intentions (mean ADE = -0.04, p = .77).","[""consumers' perceptions of sugar-sweetened fruit drinks"", 'online convenience samples of U.S. adults (Study 1 n\u202f=\u202f2139 in 2018, current e-cigarette users and smokers; Study 2 n\u202f=\u202f670 in 2018, current e-cigarette users; Study 3 n\u202f=\u202f1001 in 2019, general sample']",[],"['product healthfulness', 'purchase intentions', 'consumption interest (mean', 'appeal of fruit drinks']","[{'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0242209', 'cui_str': 'Sugars'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0452428', 'cui_str': 'Drinks (substance)'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C4087159', 'cui_str': 'Electronic cigarette user (finding)'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0966141', 'cui_str': '2-N-(APPDHP)'}, {'cui': 'C4517853', 'cui_str': '670'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}]",[],"[{'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0452428', 'cui_str': 'Drinks (substance)'}]",,0.042838,"The fruit image had no effect on perceived product healthfulness (mean ADE = 0.03, p = .81) or purchase intentions (mean ADE = -0.04, p = .77).","[{'ForeName': 'Marissa G', 'Initials': 'MG', 'LastName': 'Hall', 'Affiliation': 'Department of Health Behavior, Gillings School of Global Public Health, University of North Carolina, United States of America; Lineberger Comprehensive Cancer Center, University of North Carolina, United States of America. Electronic address: mghall@unc.edu.'}, {'ForeName': 'Allison J', 'Initials': 'AJ', 'LastName': 'Lazard', 'Affiliation': 'Lineberger Comprehensive Cancer Center, University of North Carolina, United States of America; Hussman School of Media and Journalism, University of North Carolina, United States of America.'}, {'ForeName': 'Anna H', 'Initials': 'AH', 'LastName': 'Grummon', 'Affiliation': 'Department of Health Behavior, Gillings School of Global Public Health, University of North Carolina, United States of America; Carolina Population Center, University of North Carolina, United States of America.'}, {'ForeName': 'Jennifer R', 'Initials': 'JR', 'LastName': 'Mendel', 'Affiliation': 'Lineberger Comprehensive Cancer Center, University of North Carolina, United States of America.'}, {'ForeName': 'Lindsey Smith', 'Initials': 'LS', 'LastName': 'Taillie', 'Affiliation': 'Carolina Population Center, University of North Carolina, United States of America; Department of Nutrition, Gillings School of Global Public Health, University of North Carolina, United States of America.'}]",Preventive medicine,['10.1016/j.ypmed.2020.105998'] 920,31310993,Feasibility of a Home-Based Balance Intervention in Middle-Aged Women Using Wii Fit Plus®.,"BACKGROUND This study evaluated the feasibility and effectiveness of a home-based exercise intervention using the Wii Fit Plus®. METHODS A randomized, controlled trial of 24 women (age 53.6 [5.4] y) was used to assess compliance and changes in balance over 12 weeks. Balance was measured via the Berg Balance Scale and Frailty and Injuries: Cooperative Studies of Intervention Techniques-4 Scale at baseline and week 6 and week 12. Participant compliance to the intervention was captured via paper logs and the electronic record collected by the Wii Fit Plus®. RESULTS Participants in the intervention group were 95% compliant based on electronic records. There were no significant differences between groups for total score on either balance scale. There was a significant group × time interaction in favor of the intervention for maximum velocity y (P < .05), average velocity (P < .05), and was trending for maximum velocity x (P = .05) in the tandem step, eyes closed position. CONCLUSIONS The results suggest that the Wii Fit Plus® is appropriate for home-based interventions in middle-aged women. Modest improvements in balance indicate that this may be an effective means to improve or maintain balance in older women. More research is needed to determine compliance and benefits to reducing fall risk in durations exceeding 12 weeks.",2019,"There was a significant group × time interaction in favor of the intervention for maximum velocity y (P < .05), average velocity (P < .05), and was trending for maximum velocity x (P = .05) in the tandem step, eyes closed position. ","['middle-aged women', 'Participants in the intervention group were 95% compliant based on electronic records', 'older women', '24 women (age 53.6 [5.4]\xa0y', 'Middle-Aged Women Using Wii Fit Plus®']","['Home-Based Balance Intervention', 'home-based exercise intervention']","['average velocity', 'total score on either balance scale', 'maximum velocity y']","[{'cui': 'C0205847', 'cui_str': 'Middle Aged'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0566588', 'cui_str': 'Compliant (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C4281784', 'cui_str': 'Electronics'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517792', 'cui_str': 'Five point four'}, {'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0222045'}]",,0.043176,"There was a significant group × time interaction in favor of the intervention for maximum velocity y (P < .05), average velocity (P < .05), and was trending for maximum velocity x (P = .05) in the tandem step, eyes closed position. ","[{'ForeName': 'Sarah J', 'Initials': 'SJ', 'LastName': 'Wherry', 'Affiliation': ''}, {'ForeName': 'Cheryl Der', 'Initials': 'C', 'LastName': 'Ananian', 'Affiliation': ''}, {'ForeName': 'Pamela D', 'Initials': 'PD', 'LastName': 'Swan', 'Affiliation': ''}]",Journal of physical activity & health,['10.1123/jpah.2018-0265'] 921,31310994,Estimated Physical Activity in Adolescents by Wrist-Worn GENEActiv Accelerometers.,"BACKGROUND Reports of physical activity (PA) measured via wrist-worn accelerometers in adolescents are limited. This study describes PA levels in adolescents at baseline of an obesity prevention and weight management trial. METHODS Adolescents (n = 930) at 8 high schools wore an accelerometer for 7 days, with average acceleration values of <50 mg, >150 mg, and >500 mg categorized as sedentary, moderate, and vigorous PA, respectively. In a 3-level mixed-effects generalized linear model, PA was regressed on sex, weight status, and day of week. Daily PA was nested within students, and students within schools, with random effects included for both. RESULTS Adolescents accumulated a median of 40 minutes daily of moderate to vigorous PA (MVPA). MVPA was significantly different for teens with obesity versus teens with normal weight (-5.4 min/d, P = .03); boys versus girls (16.3 min/d, P < .001); and Sundays versus midweek (-16.6 min/d, P < .001). Average sedentary time increased on weekends (Saturday: 19.1 min/d, P < .001; Sunday: 44.8 min, P < .001) relative to midweek but did not differ by sex or weight status. CONCLUSIONS Interventions to increase PA in adolescents may benefit from focusing on increasing weekend PA and increasing MVPA in girls.",2019,"Average sedentary time increased on weekends (Saturday: 19.1 min/d, P < .001; Sunday: 44.8 min, P < .001) relative to midweek but did not differ by sex or weight status. ","['Adolescents (n = 930) at 8 high schools wore an accelerometer for 7 days, with average acceleration values of <50\xa0mg, >150\xa0mg, and >500\xa0mg categorized as sedentary, moderate, and vigorous PA, respectively', 'adolescents at baseline of an obesity prevention and weight management trial', 'teens with obesity versus teens with normal weight (-5.4\xa0min']",['MVPA'],"['median of 40 minutes daily of moderate to vigorous PA (MVPA', 'Average sedentary time', 'Estimated Physical Activity']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0000894', 'cui_str': 'Acceleration'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C3816747', 'cui_str': 'Five hundred'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C1521910', 'cui_str': 'Teens'}, {'cui': 'C2712185', 'cui_str': 'Normal weight (finding)'}, {'cui': 'C4517792', 'cui_str': 'Five point four'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}]",[],"[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]",930.0,0.041892,"Average sedentary time increased on weekends (Saturday: 19.1 min/d, P < .001; Sunday: 44.8 min, P < .001) relative to midweek but did not differ by sex or weight status. ","[{'ForeName': 'Sarah G', 'Initials': 'SG', 'LastName': 'Sanders', 'Affiliation': ''}, {'ForeName': 'Elizabeth Yakes', 'Initials': 'EY', 'LastName': 'Jimenez', 'Affiliation': ''}, {'ForeName': 'Natalie H', 'Initials': 'NH', 'LastName': 'Cole', 'Affiliation': ''}, {'ForeName': 'Alena', 'Initials': 'A', 'LastName': 'Kuhlemeier', 'Affiliation': ''}, {'ForeName': 'Grace L', 'Initials': 'GL', 'LastName': 'McCauley', 'Affiliation': ''}, {'ForeName': 'M Lee', 'Initials': 'ML', 'LastName': 'Van Horn', 'Affiliation': ''}, {'ForeName': 'Alberta S', 'Initials': 'AS', 'LastName': 'Kong', 'Affiliation': ''}]",Journal of physical activity & health,['10.1123/jpah.2018-0344'] 922,32125188,"Leptin levels are not affected by enalapril treatment after an uncomplicated myocardial infarction, but associate strongly with changes in fibrinolytic variables in men.","Leptin, an adipocyte-derived hormone, is involved in the regulation of body weight and is associated with obesity-related complications, notably cardiovascular disease (CVD). A putative link between obesity and CVD could be induction of plasminogen activator inhibitor-1 (PAI-1) synthesis by leptin. In this study, we hypothesized that the beneficial effect of the angiotensin-converting enzyme inhibitor (ACE i ) enalapril on PAI-1 levels is mediated by effects on leptin levels. The association between leptin and components of the fibrinolytic system was evaluated in a non-prespecified post hoc analysis of a placebo-controlled randomized, double-blind trial where the effect of the ACE i enalapril on fibrinolysis was tested. A total of 46 men and 37 women were randomized to treatment with enalapril or placebo after (median 12 months) an uncomplicated myocardial infarction. At baseline, the participants were stable and had no signs of congestive heart failure. Leptin and fibrinolytic variables (mass concentrations of PAI-1, tissue plasminogen activator (tPA) and tPA-PAI complex) were measured at baseline, and after 10 days, 6 months and 12 months. Enalapril treatment did not change leptin levels, which increased significantly during 1 year of follow-up ( p  = .007). Changes in leptin levels were strongly associated with changes of tPA mass ( p  = .001), tPA-PAI complex ( p  = .003) and of PAI-1 ( p  = .006) in men, but not in women. Leptin levels are not influenced by treatment with an ACE i . In contrast, leptin associates strongly with changes in fibrinolytic variables notably with a sex difference, which could be of importance for obesity-related CVD.",2020,"Leptin and fibrinolytic variables (mass concentrations of PAI-1, tissue plasminogen activator (tPA) and tPA-PAI complex) were measured at baseline, and after 10 days, 6 months and 12 months.",['A total of 46 men and 37 women'],"['enalapril or placebo', 'enalapril', 'ACE i enalapril', 'Enalapril', 'angiotensin-converting enzyme inhibitor (ACE i ) enalapril']","['change leptin levels', 'Leptin levels', 'tPA mass', 'tPA-PAI complex', 'Leptin and fibrinolytic variables (mass concentrations of PAI-1, tissue plasminogen activator (tPA) and tPA-PAI complex', 'leptin levels', 'congestive heart failure', 'fibrinolytic variables']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C0014025', 'cui_str': 'Enalapril'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0067453', 'cui_str': 'N-(2-acetamido)-2-aminoethanesulfonic acid'}, {'cui': 'C0003015', 'cui_str': 'ACE Inhibitors'}]","[{'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0522326', 'cui_str': 'tPA-PAI complex'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0560150', 'cui_str': 'Unit of mass concentration'}, {'cui': 'C0030190', 'cui_str': 'SERPINE1 Protein'}, {'cui': 'C0032143', 'cui_str': 'alteplase'}, {'cui': 'C0018802', 'cui_str': 'Congestive heart failure (disorder)'}]",46.0,0.21255,"Leptin and fibrinolytic variables (mass concentrations of PAI-1, tissue plasminogen activator (tPA) and tPA-PAI complex) were measured at baseline, and after 10 days, 6 months and 12 months.","[{'ForeName': 'Maria A', 'Initials': 'MA', 'LastName': 'Eriksson', 'Affiliation': 'Department of Public Health and Clinical Medicine, Medicine, Umeå University, Umea, Sweden.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Söderberg', 'Affiliation': 'Department of Public Health and Clinical Medicine, Medicine, Umeå University, Umea, Sweden.'}, {'ForeName': 'Torbjörn K', 'Initials': 'TK', 'LastName': 'Nilsson', 'Affiliation': 'Department of Medical Biosciences/Clinical Chemistry, Umeå University, Umea, Sweden.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Eriksson', 'Affiliation': 'Department of Statistics, USBE, Umeå University, Umea, Sweden.'}, {'ForeName': 'Kurt', 'Initials': 'K', 'LastName': 'Boman', 'Affiliation': 'Research Unit Skellefteå, Department of Public Health and Clinical Medicine, Umeå University, Umea, Sweden.'}, {'ForeName': 'Jan-Håkan', 'Initials': 'JH', 'LastName': 'Jansson', 'Affiliation': 'Research Unit Skellefteå, Department of Public Health and Clinical Medicine, Umeå University, Umea, Sweden.'}]",Scandinavian journal of clinical and laboratory investigation,['10.1080/00365513.2020.1731848'] 923,31300260,Transcranial magnetic stimulation improves cognition over time in Parkinson's disease.,"INTRODUCTION Cognitive impairment can occur in the early phase of Parkinson's disease and increases the risk of developing dementia. Cognitive deficits were shown to be associated with functional alterations in the dorsolateral prefrontal cortex (DLPFC) and caudate nucleus. Two previous transcranial magnetic stimulation studies over the left DLPFC showed short-term improvement in cognitive performance and focused on specific task. METHODS 28 patients with idiopathic Parkinson's disease and mild cognitive impairment received intermittent ""theta burst"" stimulation (iTBS) (active, N = 14; or sham, N = 14) over the left DLPFC, twice a day for three days with 1-2 days in between. Detailed neuropsychological assessment of five cognitive domains was performed before iTBS and on days 1, 10, and 30 after the last iTBS session. Composite Z-scores were calculated for each domain and for overall cognition. RESULTS Our results showed an increase in overall cognition up to one month in both groups but this effect was only significant in the active group. Improvements were seen in the attention domain for both groups and in the visuospatial domain in the active group only. No significant differences were found between the groups. CONCLUSION These preliminary findings suggest that active iTBS might improve overall cognitive performance in patients with Parkinson's disease with mild cognitive impairment and that this effect can last up to one month. This cognitive improvement, is likely mediated by improvement on visuospatial abilities. Further studies are needed to explore the potential of iTBS as a therapeutical tool to slow cognitive decline in patients with Parkinson's disease.",2019,Our results showed an increase in overall cognition up to one month in both groups but this effect was only significant in the active group.,"[""patients with Parkinson's disease with mild cognitive impairment"", ""28 patients with idiopathic Parkinson's disease and mild cognitive impairment received"", ""patients with Parkinson's disease"", ""Parkinson's disease""]","['intermittent ""theta burst"" stimulation (iTBS) (active, N\u202f=\u202f14; or sham, N\u202f=\u202f14) over the left DLPFC', 'Transcranial magnetic stimulation', 'active iTBS']","['Composite Z-scores', 'overall cognitive performance', 'Cognitive deficits', 'visuospatial abilities', 'cognitive performance', 'overall cognition']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0030567', 'cui_str': 'Idiopathic Parkinson Disease'}, {'cui': 'C1270972', 'cui_str': 'Mild Neurocognitive Disorder'}]","[{'cui': 'C0205267', 'cui_str': 'Intermittent (qualifier value)'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation (procedure)'}]","[{'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0338656', 'cui_str': 'Cognitive Dysfunction'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}]",28.0,0.0211076,Our results showed an increase in overall cognition up to one month in both groups but this effect was only significant in the active group.,"[{'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Trung', 'Affiliation': ""CIUSSS Centre-Sud-de-l'Île-de-Montréal, Centre de Recherche de l'Institut Universitaire de Gériatrie de Montréal, Montréal, QC, Canada.""}, {'ForeName': 'Alexandru', 'Initials': 'A', 'LastName': 'Hanganu', 'Affiliation': ""CIUSSS Centre-Sud-de-l'Île-de-Montréal, Centre de Recherche de l'Institut Universitaire de Gériatrie de Montréal, Montréal, QC, Canada; Department of Clinical Neurosciences and Department of Radiology, University of Calgary, Calgary, AB, Canada; Hotchkiss Brain Institute, Cumming School of Medicine, Calgary, AB, Canada; Department of Psychology, University of Montreal, Montreal, QC, Canada.""}, {'ForeName': 'Stevan', 'Initials': 'S', 'LastName': 'Jobert', 'Affiliation': ""CIUSSS Centre-Sud-de-l'Île-de-Montréal, Centre de Recherche de l'Institut Universitaire de Gériatrie de Montréal, Montréal, QC, Canada.""}, {'ForeName': 'Clotilde', 'Initials': 'C', 'LastName': 'Degroot', 'Affiliation': ""CIUSSS Centre-Sud-de-l'Île-de-Montréal, Centre de Recherche de l'Institut Universitaire de Gériatrie de Montréal, Montréal, QC, Canada; McGill University, Montreal, QC, Canada.""}, {'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Mejia-Constain', 'Affiliation': ""CIUSSS Centre-Sud-de-l'Île-de-Montréal, Centre de Recherche de l'Institut Universitaire de Gériatrie de Montréal, Montréal, QC, Canada.""}, {'ForeName': 'Mekale', 'Initials': 'M', 'LastName': 'Kibreab', 'Affiliation': 'Department of Clinical Neurosciences and Department of Radiology, University of Calgary, Calgary, AB, Canada; Hotchkiss Brain Institute, Cumming School of Medicine, Calgary, AB, Canada.'}, {'ForeName': 'Marie-Andrée', 'Initials': 'MA', 'LastName': 'Bruneau', 'Affiliation': ""CIUSSS Centre-Sud-de-l'Île-de-Montréal, Centre de Recherche de l'Institut Universitaire de Gériatrie de Montréal, Montréal, QC, Canada.""}, {'ForeName': 'Anne-Louise', 'Initials': 'AL', 'LastName': 'Lafontaine', 'Affiliation': 'Movement Disorders Unit, McGill University Health Center, Montreal, QC, Canada.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Strafella', 'Affiliation': 'Department of Medicine, Division of Neurology, University of Toronto, ON, Canada.'}, {'ForeName': 'Oury', 'Initials': 'O', 'LastName': 'Monchi', 'Affiliation': ""CIUSSS Centre-Sud-de-l'Île-de-Montréal, Centre de Recherche de l'Institut Universitaire de Gériatrie de Montréal, Montréal, QC, Canada; Department of Clinical Neurosciences and Department of Radiology, University of Calgary, Calgary, AB, Canada; Hotchkiss Brain Institute, Cumming School of Medicine, Calgary, AB, Canada; McGill University, Montreal, QC, Canada. Electronic address: oury.monchi@ucalgary.ca.""}]",Parkinsonism & related disorders,['10.1016/j.parkreldis.2019.07.006'] 924,31310990,Effect of Breaks in Prolonged Sitting or Low-Volume High-Intensity Interval Exercise on Markers of Metabolic Syndrome in Adults With Excess Body Fat: A Crossover Trial.,"BACKGROUND This study analyzed the effect of walking breaks or low-volume high-intensity interval exercise (LV-HIIE) on markers of metabolic syndrome relative to a day of prolonged sitting. METHODS Twenty-five adults with excess body fat participated in this crossover trial: (1) 10-hour sitting day (SIT), (2) LV-HIIE followed by a sitting day (EX+SIT), and (3) sitting day with 5-minute walking breaks for every 20 minutes (SIT+WB). Glucose and blood pressure (BP) were measured before and 1 hour after 4 meals and 2 hours after lunch. Triglycerides were measured at baseline, 2, and 3.5 hours after lunch. Generalized mixed models were used to identify differences in the area under the curve (AUC) of BP and incremental AUC (iAUC) of glucose and triglycerides among the sessions. RESULTS iAUC-glucose was lower in SIT+WB than SIT (β = -35.3 mg/dL·10 h; 95% confidence interval, -52.5 to -8.2). AUC-diastolic BP was lower in SIT+WB than SIT (β = -14.1 mm Hg·10 h; 95% confidence interval, -26.5 to -1.6) and EX+SIT (β = -14.5 mm Hg·10 h; 95% confidence interval, -26.9 to -2.1). There were no differences in triglycerides and systolic BP levels among the sessions. CONCLUSION Adults with excess body fat present lower glucose and diastolic BP during a day with breaks in sitting time compared with a prolonged sitting day with or without an LV-HIIE session.",2019,"RESULTS iAUC-glucose was lower in SIT+WB than SIT (β = -35.3 mg/dL·10 h; 95% confidence interval, -52.5 to -8.2).","['Twenty-five adults with excess body fat participated in this crossover trial', 'Adults With Excess Body Fat']","['Breaks in Prolonged Sitting or Low-Volume High-Intensity Interval Exercise', 'walking breaks or low-volume high-intensity interval exercise (LV-HIIE']","['Glucose and blood pressure (BP', 'area under the curve (AUC) of BP and incremental AUC (iAUC) of glucose and triglycerides', 'AUC-diastolic BP', 'Triglycerides', 'glucose and diastolic BP', 'iAUC-glucose', 'triglycerides and systolic BP levels']","[{'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0344335', 'cui_str': 'Body Fat'}, {'cui': 'C0150097', 'cui_str': 'Crossover Trials'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0080331', 'cui_str': 'Walking'}]","[{'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",25.0,0.111075,"RESULTS iAUC-glucose was lower in SIT+WB than SIT (β = -35.3 mg/dL·10 h; 95% confidence interval, -52.5 to -8.2).","[{'ForeName': 'Yuri Alberto', 'Initials': 'YA', 'LastName': 'Freire', 'Affiliation': ''}, {'ForeName': 'Geovani de Araújo Dantas de', 'Initials': 'GAD', 'LastName': 'Macêdo', 'Affiliation': ''}, {'ForeName': 'Rodrigo Alberto Vieira', 'Initials': 'RAV', 'LastName': 'Browne', 'Affiliation': ''}, {'ForeName': 'Luiz Fernando', 'Initials': 'LF', 'LastName': 'Farias-Junior', 'Affiliation': ''}, {'ForeName': 'Ágnes Denise de Lima', 'Initials': 'ÁDL', 'LastName': 'Bezerra', 'Affiliation': ''}, {'ForeName': 'Ana Paula Trussardi', 'Initials': 'APT', 'LastName': 'Fayh', 'Affiliation': ''}, {'ForeName': 'José Cazuza de', 'Initials': 'JC', 'LastName': 'Farias Júnior', 'Affiliation': ''}, {'ForeName': 'Kevin F', 'Initials': 'KF', 'LastName': 'Boreskie', 'Affiliation': ''}, {'ForeName': 'Todd A', 'Initials': 'TA', 'LastName': 'Duhamel', 'Affiliation': ''}, {'ForeName': 'Eduardo Caldas', 'Initials': 'EC', 'LastName': 'Costa', 'Affiliation': ''}]",Journal of physical activity & health,['10.1123/jpah.2018-0492'] 925,31310991,Randomized Controlled Trial of Primary Health Care Strategies for the Promotion of Leisure-Time Physical Activity Among Older Brazilians.,"BACKGROUND Physical activity promotion within primary health care is in the spotlight. However, few studies have evaluated the long-term effectiveness of possible interventions. This study aimed to compare the effectiveness of 3 primary health care interventions in increasing leisure-time physical activity among older Brazilians. METHODS Experimental study with 142 older residents of an ongoing urban cohort in São Paulo (Brazil). Participants were randomized into 3 groups: minimal intervention group, physician-based counseling group, and individual counseling and referral for physical activity programs group (CRG). We used the long version of the International Physical Activity Questionnaire to assess leisure-time physical activity at baseline, 4 years after baseline without any intervention, 3 months after intervention, and 6 months after intervention. Statistical analysis included repeated analysis of variance. RESULTS At baseline, 31% of the individuals were active, and this figure remained stable for a period of 4 years. Three months after the interventions, there was a significant increase in leisure-time physical activity for CRG compared with the minimal intervention (P < .001) and physician-based counseling (P < .02) groups, and these differences persisted after 6 months (P < .001 and P < .05, respectively). CONCLUSION Results indicate that interventions with CRG are effective in producing sustained changes in physical activity among older Brazilians.",2019,"Three months after the interventions, there was a significant increase in leisure-time physical activity for CRG compared with the minimal intervention (P < .001) and physician-based counseling (P < .02) groups, and these differences persisted after 6 months (P < .001 and P < .05, respectively). ","['142 older residents of an ongoing urban cohort in São Paulo (Brazil', 'Older Brazilians', 'older Brazilians']","['minimal intervention group, physician-based counseling group, and individual counseling and referral for physical activity programs group (CRG', '3 primary health care interventions']",['leisure-time physical activity for CRG'],"[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}]","[{'cui': 'C0547040', 'cui_str': 'Minimal (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C2585524', 'cui_str': 'Referral for'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}]","[{'cui': 'C0086542', 'cui_str': 'Leisure'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]",,0.0270923,"Three months after the interventions, there was a significant increase in leisure-time physical activity for CRG compared with the minimal intervention (P < .001) and physician-based counseling (P < .02) groups, and these differences persisted after 6 months (P < .001 and P < .05, respectively). ","[{'ForeName': 'Francini Vilela', 'Initials': 'FV', 'LastName': 'Novais', 'Affiliation': ''}, {'ForeName': 'Eduardo J', 'Initials': 'EJ', 'LastName': 'Simoes', 'Affiliation': ''}, {'ForeName': 'Chester', 'Initials': 'C', 'LastName': 'Schmaltz', 'Affiliation': ''}, {'ForeName': 'Luiz R', 'Initials': 'LR', 'LastName': 'Ramos', 'Affiliation': ''}]",Journal of physical activity & health,['10.1123/jpah.2017-0502'] 926,31301476,Self-guided internet-delivered cognitive behavior therapy (ICBT) for obsessive-compulsive symptoms: A randomized controlled trial.,"Internet-delivered cognitive behavior therapy (ICBT) for obsessive-compulsive disorder (OCD) has been demonstrated to be efficacious across multiple clinical trials. However, most of these interventions include clinician support, and many individuals with OCD prefer to manage their own symptoms. Self-guided ICBT overcomes this problem, but to date the efficacy of self-guided interventions has only been studied in uncontrolled trials. The present study aims to examine the efficacy and acceptability of ICBT for OCD symptoms when delivered in a self-guided format using a randomized controlled trial design. In the present study, 190 participants were randomized to either a self-guided ICBT condition or a waitlist control group. 140 participants completed the baseline assessment, initiated treatment, and were included in the analyses. The between-group effect size at post-treatment was large on the self-report version of the Yale-Brown Obsessive-Compulsive Scale (d = 1.05; 95% CI 0.89-1.21). Twenty-seven percent of the ICBT condition met conservative criteria for clinically significant change at post-treatment, which increased to thirty-eight percent at three-month follow-up. Participants rated the program as highly acceptable. The results indicate that self-guided ICBT may be a viable treatment option for some individuals with OCD symptoms.",2019,The between-group effect size at post-treatment was large on the self-report version of the Yale-Brown Obsessive-Compulsive Scale (d = 1.05; 95% CI 0.89-1.21).,"['obsessive-compulsive disorder (OCD', '140 participants completed the baseline assessment, initiated treatment, and were included in the analyses', 'obsessive-compulsive symptoms', '190 participants']","['self-guided ICBT condition or a waitlist control group', 'Internet-delivered cognitive behavior therapy (ICBT', 'ICBT', 'Self-guided internet-delivered cognitive behavior therapy (ICBT']","['self-report version of the Yale-Brown Obsessive-Compulsive Scale', 'efficacy and acceptability']","[{'cui': 'C0028768', 'cui_str': 'Anankastic Personality'}, {'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C4087290', 'cui_str': 'Obsessive-compulsive symptom'}, {'cui': 'C4517622', 'cui_str': 'One hundred and ninety'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C0678579', 'cui_str': 'Brown'}, {'cui': 'C0222045'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}]",190.0,0.0554015,The between-group effect size at post-treatment was large on the self-report version of the Yale-Brown Obsessive-Compulsive Scale (d = 1.05; 95% CI 0.89-1.21).,"[{'ForeName': 'Bethany M', 'Initials': 'BM', 'LastName': 'Wootton', 'Affiliation': 'University of Technology Sydney, NSW, Australia; Macquarie University, Sydney, NSW, Australia. Electronic address: bethany.wootton@uts.edu.au.'}, {'ForeName': 'Eyal', 'Initials': 'E', 'LastName': 'Karin', 'Affiliation': 'Macquarie University, Sydney, NSW, Australia.'}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Titov', 'Affiliation': 'Macquarie University, Sydney, NSW, Australia.'}, {'ForeName': 'Blake F', 'Initials': 'BF', 'LastName': 'Dear', 'Affiliation': 'Macquarie University, Sydney, NSW, Australia.'}]",Journal of anxiety disorders,['10.1016/j.janxdis.2019.102111'] 927,31659612,A New Prognostic Model Based on Albumin-Bilirubin Grade for Hepatocellular Carcinoma Beyond the Milan Criteria.,"BACKGROUND The survival of patients with advanced hepatocellular carcinoma (HCC) is highly variable due to heterogeneous tumoral characteristics. We proposed and validated an albumin-bilirubin (ALBI)-based model for HCC beyond Milan criteria, the ALBI-HOME, for these patients. METHODS A total of 2186 patients were enrolled and randomly assigned to the derivation cohort (n = 1093) and validation cohort (n = 1093). Multivariate Cox proportional hazards model was used to determine significant prognostic factors in the derivation cohort. The performance of ALBI-HOME was evaluated in the validation cohort. RESULTS In the Cox model, six factors were identified as independent predictors of poor survival: ALBI grade 2 [hazard ratio (HR) 1.848, 95% confidence incidence (CI) 1.556-2.195, p < 0.001], ALBI grade 3 (HR 3.266, 95% CI 2.531-4.215, p < 0.001), serum AFP ≥ 100 ng/ml (HR 1.482, 95% CI 1.279-1.717, p < 0.001), total tumor volume ≥ 250 cm 3 (HR 1.503, 95% CI 1.294-1.746, p < 0.001), ascites (HR 1.400, 95% CI 1.187-1.561, p < 0.001), performance status 0-1 (HR 1.756, 95% CI 1.485-2.076 p < 0.001), and vascular invasion or metastasis (HR 2.110, 95% CI 1.809-2.0, p < 0.001). The ALBI-HOME is based on these six parameters, and the score ranges from 0 to 7. This model was associated with the best prognostic ability among different HCC staging systems to predict survival in patients beyond Milan criteria; its ability remained consistently stable in different treatment subgroups and viral etiologies. CONCLUSIONS The proposed ALBI-HOME is a simple and feasible predictive model for HCC beyond Milan criteria. It demonstrates superior prognostic performance among the currently used staging systems and may help identify at-risk patients to undergo more aggressive treatments.",2020,"250 cm 3 (HR 1.503, 95% CI 1.294-1.746, p < 0.001), ascites (HR 1.400, 95% CI 1.187-1.561, p < 0.001), performance status 0-1 (HR 1.756, 95% CI 1.485-2.076 p < 0.001), and vascular invasion or metastasis (HR 2.110, 95% CI 1.809-2.0, p < 0.001).","['patients with advanced hepatocellular carcinoma (HCC', '2186 patients were enrolled and randomly assigned to the derivation cohort (n\u2009=\u20091093) and validation cohort (n\u2009=\u20091093']",[],"['total tumor volume\u2009≥', 'poor survival', 'performance of ALBI-HOME', 'serum AFP\u2009≥', 'ascites', 'vascular invasion or metastasis', 'ALBI grade 2 [hazard ratio (HR']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C2239176', 'cui_str': 'Liver Cell Carcinoma, Adult'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}]",[],"[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0475276', 'cui_str': 'Tumor Volume'}, {'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0003962', 'cui_str': 'Ascites'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",2186.0,0.136317,"250 cm 3 (HR 1.503, 95% CI 1.294-1.746, p < 0.001), ascites (HR 1.400, 95% CI 1.187-1.561, p < 0.001), performance status 0-1 (HR 1.756, 95% CI 1.485-2.076 p < 0.001), and vascular invasion or metastasis (HR 2.110, 95% CI 1.809-2.0, p < 0.001).","[{'ForeName': 'Shu-Yein', 'Initials': 'SY', 'LastName': 'Ho', 'Affiliation': 'Department of Medicine, Taipei Veterans General Hospital, Taipei, Taiwan.'}, {'ForeName': 'Po-Hong', 'Initials': 'PH', 'LastName': 'Liu', 'Affiliation': 'Faculty of Medicine, National Yang-Ming University School of Medicine, Taipei, Taiwan.'}, {'ForeName': 'Chia-Yang', 'Initials': 'CY', 'LastName': 'Hsu', 'Affiliation': 'Faculty of Medicine, National Yang-Ming University School of Medicine, Taipei, Taiwan.'}, {'ForeName': 'Cheng-Yuan', 'Initials': 'CY', 'LastName': 'Hsia', 'Affiliation': 'Department of Surgery, Taipei Veterans General Hospital, Taipei, Taiwan.'}, {'ForeName': 'Yi-Hsiang', 'Initials': 'YH', 'LastName': 'Huang', 'Affiliation': 'Department of Medicine, Taipei Veterans General Hospital, Taipei, Taiwan.'}, {'ForeName': 'Chien-Wei', 'Initials': 'CW', 'LastName': 'Su', 'Affiliation': 'Department of Medicine, Taipei Veterans General Hospital, Taipei, Taiwan.'}, {'ForeName': 'Hao-Jan', 'Initials': 'HJ', 'LastName': 'Lei', 'Affiliation': 'Department of Surgery, Taipei Veterans General Hospital, Taipei, Taiwan.'}, {'ForeName': 'Rheun-Chuan', 'Initials': 'RC', 'LastName': 'Lee', 'Affiliation': 'Department of Radiology, Taipei Veterans General Hospital, Taipei, Taiwan.'}, {'ForeName': 'Ming-Chih', 'Initials': 'MC', 'LastName': 'Hou', 'Affiliation': 'Department of Medicine, Taipei Veterans General Hospital, Taipei, Taiwan.'}, {'ForeName': 'Teh-Ia', 'Initials': 'TI', 'LastName': 'Huo', 'Affiliation': 'Department of Medicine, Taipei Veterans General Hospital, Taipei, Taiwan. tihuo@vghtpe.gov.tw.'}]",Digestive diseases and sciences,['10.1007/s10620-019-05813-1'] 928,31313973,"Effects of Nurse-Led Support Via WeChat , a Smartphone Application, for Breast Cancer Patients After Surgery: A Quasi-Experimental Study.","Background: Women with breast cancer (BC) commonly experience physical and psychosocial symptoms after surgery. Web- and smartphone-based support can significantly improve women's symptoms and quality of life. Social care applications (apps) are widely used in China, but there are few studies on their effectiveness BC support. This study aimed to examine the effects of nurse-led support on the social care app WeChat ® (Tencent Holdings Limited, Shenzhen, China) in BC patients after surgery. Methods: A quasi-experimental study was conducted between June 2015 and August 2015. Sixty patients with BC (30 in the intervention group, 30 in the control group) were enrolled. Subjects in the intervention group participated in a WeChat-based support program (WSP) led by nurses, while subjects in the control group received a follow-up by telephone. Subjects in both groups were evaluated at the time of discharge and at 1, 3, and 6 months of follow-up. Physical well-being status, psychology status, and social support were evaluated. Results: There were no differences between intervention and control patients at baseline. Physical well-being ( p < 0.001), anxiety ( p < 0.001), depression ( p < 0.001), and support from outside of family ( p  = 0.037) were significantly better in the intervention group than in the control group after 6 months. The intervention group showed that physical well-being ( p  = 0.036), anxiety ( p < 0.001), and depression ( p < 0.001) were significantly different from baseline to 6 months of follow-up. Conclusion: WSP assisted with nurse-led support and had physical, psychological, and social benefits for patients after surgery for BC.",2020,"The intervention group showed that physical well-being ( p  = 0.036), anxiety ( p < 0.001), and depression ( p < 0.001) were significantly different from baseline to 6 months of follow-up. ","['A quasi-experimental study was conducted between June 2015 and August 2015', 'Breast Cancer Patients', 'Sixty patients with BC (30 in the intervention group, 30 in the control group) were enrolled', 'BC patients after surgery', 'Women with breast cancer (BC) commonly experience physical and psychosocial symptoms after surgery']","['nurse-led support', 'Nurse-Led Support', 'WeChat-based support program (WSP) led by nurses, while subjects in the control group received a follow-up by telephone']","['Physical well-being status, psychology status, and social support', 'anxiety ', 'depression', ""women's symptoms and quality of life"", 'anxiety']","[{'cui': 'C2985410', 'cui_str': 'Clinical Trials, Nonrandomized'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]","[{'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}]","[{'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0033909', 'cui_str': 'Psychology'}, {'cui': 'C0037438'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0034380'}]",60.0,0.0279404,"The intervention group showed that physical well-being ( p  = 0.036), anxiety ( p < 0.001), and depression ( p < 0.001) were significantly different from baseline to 6 months of follow-up. ","[{'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Wu', 'Affiliation': ""Department of General Surgery, Tenth People's Hospital of Tongji University, Shanghai, China.""}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Kue', 'Affiliation': 'Office of Global Innovations, College of Nursing, The Ohio State University, Columbus, Ohio.'}, {'ForeName': 'Xiaoping', 'Initials': 'X', 'LastName': 'Zhu', 'Affiliation': ""Department of General Surgery, Tenth People's Hospital of Tongji University, Shanghai, China.""}, {'ForeName': 'Xiaobing', 'Initials': 'X', 'LastName': 'Yin', 'Affiliation': ""Department of General Surgery, Tenth People's Hospital of Tongji University, Shanghai, China.""}, {'ForeName': 'Jinxia', 'Initials': 'J', 'LastName': 'Jiang', 'Affiliation': 'School of Nursing, The Hong Kong Polytechnic University, Hong Kong.'}, {'ForeName': 'Jingjuan', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': ""Department of General Surgery, Tenth People's Hospital of Tongji University, Shanghai, China.""}, {'ForeName': 'Limin', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': ""Department of General Surgery, Tenth People's Hospital of Tongji University, Shanghai, China.""}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Zeng', 'Affiliation': ""Department of General Surgery, Tenth People's Hospital of Tongji University, Shanghai, China.""}, {'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'Sun', 'Affiliation': ""Department of General Surgery, Tenth People's Hospital of Tongji University, Shanghai, China.""}, {'ForeName': 'Xianliang', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'School of Nursing, The Hong Kong Polytechnic University, Hong Kong.'}, {'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Duan', 'Affiliation': ""Department of General Surgery, Tenth People's Hospital of Tongji University, Shanghai, China.""}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Shi', 'Affiliation': ""Department of General Surgery, Tenth People's Hospital of Tongji University, Shanghai, China.""}]",Telemedicine journal and e-health : the official journal of the American Telemedicine Association,['10.1089/tmj.2018.0293'] 929,31314045,Comparison of Major Adverse Cardiac Events Between Instantaneous Wave-Free Ratio and Fractional Flow Reserve-Guided Strategy in Patients With or Without Type 2 Diabetes: A Secondary Analysis of a Randomized Clinical Trial.,"Importance Invasive physiologic indices such as fractional flow reserve (FFR) and instantaneous wave-free ratio (iFR) are used in clinical practice. Nevertheless, comparative prognostic outcomes of iFR-guided and FFR-guided treatment in patients with type 2 diabetes have not yet been fully investigated. Objective To compare 1-year clinical outcomes of iFR-guided or FFR-guided treatment in patients with and without diabetes in the Functional Lesion Assessment of Intermediate Stenosis to Guide Revascularization (DEFINE-FLAIR) trial. Design, Setting, and Participants The DEFINE-FLAIR trial is a multicenter, international, randomized, double-blinded trial that randomly assigned 2492 patients in a 1:1 ratio to undergo either iFR-guided or FFR-guided coronary revascularization. Patients were eligible for trial inclusion if they had intermediate coronary artery disease (40%-70% diameter stenosis) in at least 1 native coronary artery. Data were analyzed between January 2014 and December 2015. Interventions According to the study protocol, iFR of 0.89 or less and FFR of 0.80 or less were used as criteria for revascularization. When iFR or FFR was higher than the prespecified threshold, revascularization was deferred. Main Outcomes and Measures The primary end point was major adverse cardiac events (MACE), defined as the composite of all-cause death, nonfatal myocardial infarction, or unplanned revascularization at 1 year. The incidence of MACE was compared according to the presence of diabetes in iFR-guided and FFR-guided groups. Results Among the total trial population (2492 patients), 758 patients (30.4%) had diabetes. Mean age of the patients was 66 years, 76% were men (1868 of 2465), and 80% of patients presented with stable angina (1983 of 2465). In the nondiabetes population (68.5%; 1707 patients), iFR guidance was associated with a significantly higher rate of deferral of revascularization than the FFR-guided group (56.5% [n = 477 of 844] vs 46.6% [n = 402 of 863]; P < .001). However, it was not different between the 2 groups in the diabetes population (42.1% [n = 161 of 382] vs 47.1% [n = 177 of 376]; P = .15). At 1 year, the diabetes population showed a significantly higher rate of MACE than the nondiabetes population (8.6% vs 5.6%; adjusted hazard ratio [HR], 1.88; 95% CI, 1.28-2.64; P < .001). However, there was no significant difference in MACE rates between iFR-guided and FFR-guided groups in both the diabetes (10.0% vs 7.2%; adjusted HR, 1.33; 95% CI, 0.78-2.25; P = .30) and nondiabetes population (4.7% vs 6.4%; HR, 0.83; 95% CI, 0.51-1.35; P = .45) (interaction P = .25). Conclusions and Relevance The diabetes population showed significantly higher risk of MACE than the nondiabetes population, even with the iFR-guided or FFR-guided treatment. The iFR-guided and FFR-guided treatment showed comparable risk of MACE and provided equal safety in selecting revascularization target among patients with diabetes. Trial Registration ClinicalTrials.gov identifier: NCT02053038.",2019,"The iFR-guided and FFR-guided treatment showed comparable risk of MACE and provided equal safety in selecting revascularization target among patients with diabetes. ","['patients with and without diabetes in the Functional Lesion Assessment of Intermediate Stenosis to Guide Revascularization (DEFINE-FLAIR) trial', 'total trial population (2492 patients), 758 patients (30.4%) had diabetes', '2492 patients in a 1:1 ratio to undergo either', 'Mean age of the patients was 66 years, 76% were men (1868 of 2465), and 80% of patients presented with stable angina (1983 of 2465', 'Patients With or Without Type 2 Diabetes', 'Patients were eligible for trial inclusion if they had intermediate coronary artery disease (40%-70% diameter stenosis) in at least 1 native coronary artery', 'patients with type 2 diabetes', 'patients with diabetes']","['iFR-guided or FFR-guided treatment', 'iFR-guided or FFR-guided coronary revascularization', 'iFR-guided and FFR-guided treatment']","['rate of deferral of revascularization', 'iFR guidance', 'rate of MACE', 'fractional flow reserve (FFR) and instantaneous wave-free ratio (iFR', 'MACE rates', 'major adverse cardiac events (MACE), defined as the composite of all-cause death, nonfatal myocardial infarction, or unplanned revascularization at 1 year']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C1261287', 'cui_str': 'Stenosis'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0340288', 'cui_str': 'Angina Pectoris, Stable'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}, {'cui': 'C1301886', 'cui_str': 'Diameter (qualifier value)'}, {'cui': 'C0302891', 'cui_str': 'Native (qualifier value)'}, {'cui': 'C0205042', 'cui_str': 'Coronary artery structure'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}]","[{'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0877341', 'cui_str': 'Coronary revascularisation'}]","[{'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}, {'cui': 'C0349381', 'cui_str': 'Mace (substance)'}, {'cui': 'C1299469', 'cui_str': 'Fractional flow reserve'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]",2492.0,0.0609224,"The iFR-guided and FFR-guided treatment showed comparable risk of MACE and provided equal safety in selecting revascularization target among patients with diabetes. ","[{'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'Joo Myung', 'Initials': 'JM', 'LastName': 'Lee', 'Affiliation': 'Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea.'}, {'ForeName': 'Ki Hong', 'Initials': 'KH', 'LastName': 'Choi', 'Affiliation': 'Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea.'}, {'ForeName': 'Bon-Kwon', 'Initials': 'BK', 'LastName': 'Koo', 'Affiliation': 'Seoul National University Hospital and Institute on Aging, Seoul National University, Seoul, South Korea.'}, {'ForeName': 'Hakim-Moulay', 'Initials': 'HM', 'LastName': 'Dehbi', 'Affiliation': 'Cancer Research UK and University College London Cancer Trials Centre, University College London, London, England.'}, {'ForeName': 'Joon-Hyung', 'Initials': 'JH', 'LastName': 'Doh', 'Affiliation': 'Inje University Ilsan Paik Hospital, Daehwa-Dong, South Korea.'}, {'ForeName': 'Chang-Wook', 'Initials': 'CW', 'LastName': 'Nam', 'Affiliation': 'Keimyung University Dongsan Medical Center, Daegu, South Korea.'}, {'ForeName': 'Eun-Seok', 'Initials': 'ES', 'LastName': 'Shin', 'Affiliation': 'Ulsan Hospital, Ulsan, South Korea and Ulsan University Hospital, University of Ulsan College of Medicine, Ulsan, South Korea.'}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': 'Cook', 'Affiliation': 'Hammersmith Hospital, Imperial College London, London, England.'}, {'ForeName': 'Rasha', 'Initials': 'R', 'LastName': 'Al-Lamee', 'Affiliation': 'Hammersmith Hospital, Imperial College London, London, England.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Petraco', 'Affiliation': 'Hammersmith Hospital, Imperial College London, London, England.'}, {'ForeName': 'Sayan', 'Initials': 'S', 'LastName': 'Sen', 'Affiliation': 'Hammersmith Hospital, Imperial College London, London, England.'}, {'ForeName': 'Iqbal S', 'Initials': 'IS', 'LastName': 'Malik', 'Affiliation': 'Hammersmith Hospital, Imperial College London, London, England.'}, {'ForeName': 'Sukhjinder S', 'Initials': 'SS', 'LastName': 'Nijjer', 'Affiliation': 'Hammersmith Hospital, Imperial College London, London, England.'}, {'ForeName': 'Hernán', 'Initials': 'H', 'LastName': 'Mejía-Rentería', 'Affiliation': 'Hospital Clínico San Carlos, IDISSC and Universidad Complutense de Madrid, Madrid, Spain.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Alegria-Barrero', 'Affiliation': 'Hospital Universitario de Torrejón, Universidad Francisco de Vitoria, Madrid, Spain.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Alghamdi', 'Affiliation': 'King Abdulaziz Medical City Cardiac Center, Riyadh, Saudi Arabia.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Altman', 'Affiliation': 'Colorado Heart and Vascular, Lakewood, Colorado.'}, {'ForeName': 'Sérgio B', 'Initials': 'SB', 'LastName': 'Baptista', 'Affiliation': 'Hospital Prof Doutor Fernando Fonseca, Amadora, Portugal.'}, {'ForeName': 'Ravinay', 'Initials': 'R', 'LastName': 'Bhindi', 'Affiliation': 'Royal North Shore Hospital, Sydney, Australia.'}, {'ForeName': 'Waldemar', 'Initials': 'W', 'LastName': 'Bojara', 'Affiliation': 'Gemeinschaftsklinikum Mittelrhein, Kemperhof Koblenz, Koblenz, Germany.'}, {'ForeName': 'Salvatore', 'Initials': 'S', 'LastName': 'Brugaletta', 'Affiliation': ""Cardiovascular Institute, Hospital Clinic, Institut d'Investigacions Biomèdiques August Pi i Sunyer, Barcelona, Spain.""}, {'ForeName': 'Pedro Canas', 'Initials': 'PC', 'LastName': 'Silva', 'Affiliation': 'Hospital Santa Maria, Lisbon, Portugal.'}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Di Mario', 'Affiliation': 'Royal Brompton Hospital, Imperial College London, London, England.'}, {'ForeName': 'Andrejs', 'Initials': 'A', 'LastName': 'Erglis', 'Affiliation': 'Pauls Stradins Clinical University Hospital, Riga, Latvia.'}, {'ForeName': 'Robert T', 'Initials': 'RT', 'LastName': 'Gerber', 'Affiliation': 'Conquest Hospital, St Leonards-on-Sea, England.'}, {'ForeName': 'Olaf', 'Initials': 'O', 'LastName': 'Going', 'Affiliation': 'Sana Klinikum Lichtenberg, Lichtenberg, Germany.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Härle', 'Affiliation': 'Klinikum Oldenburg, European Medical School, Carl von Ossietzky University, Oldenburg, Germany.'}, {'ForeName': 'Farrel', 'Initials': 'F', 'LastName': 'Hellig', 'Affiliation': 'Sunninghill Hospital, Johannesburg, South Africa.'}, {'ForeName': 'Ciro', 'Initials': 'C', 'LastName': 'Indolfi', 'Affiliation': 'University Magna Graecia, Catanzaro, Italy.'}, {'ForeName': 'Luc', 'Initials': 'L', 'LastName': 'Janssens', 'Affiliation': 'Imelda Hospital, Bonheiden, Belgium.'}, {'ForeName': 'Allen', 'Initials': 'A', 'LastName': 'Jeremias', 'Affiliation': 'Stony Brook University Medical Center, New York, New York.'}, {'ForeName': 'Rajesh K', 'Initials': 'RK', 'LastName': 'Kharbanda', 'Affiliation': 'John Radcliffe Hospital, Oxford University Hospitals Foundation Trust, Oxford, England.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Khashaba', 'Affiliation': 'Ain Shams University, Cairo, Egypt.'}, {'ForeName': 'Yuetsu', 'Initials': 'Y', 'LastName': 'Kikuta', 'Affiliation': 'Fukuyama Cardiovascular Hospital, Fukuyama, Japan.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Krackhardt', 'Affiliation': 'Charite Campus Virchow Klinikum, Universitaetsmedizin, Berlin, Germany.'}, {'ForeName': 'Mika', 'Initials': 'M', 'LastName': 'Laine', 'Affiliation': 'Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Sam J', 'Initials': 'SJ', 'LastName': 'Lehman', 'Affiliation': 'Flinders University, Adelaide, South Australia, Australia.'}, {'ForeName': 'Hitoshi', 'Initials': 'H', 'LastName': 'Matsuo', 'Affiliation': 'Gifu Heart Center, Gifu, Japan.'}, {'ForeName': 'Martijin', 'Initials': 'M', 'LastName': 'Meuwissen', 'Affiliation': 'Amphia Hospital, Breda, the Netherlands.'}, {'ForeName': 'Giampaolo', 'Initials': 'G', 'LastName': 'Niccoli', 'Affiliation': 'Catholic University of the Sacred Heart, Rome, Italy.'}, {'ForeName': 'Jan J', 'Initials': 'JJ', 'LastName': 'Piek', 'Affiliation': 'AMC Heart Center, Academic Medical Center, Amsterdam, the Netherlands.'}, {'ForeName': 'Flavo', 'Initials': 'F', 'LastName': 'Ribichini', 'Affiliation': 'University Hospital Verona, Verona, Italy.'}, {'ForeName': 'Habib', 'Initials': 'H', 'LastName': 'Samady', 'Affiliation': 'Emory University, Atlanta, Georgia.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Sapontis', 'Affiliation': 'Monash Heart, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Arnold H', 'Initials': 'AH', 'LastName': 'Seto', 'Affiliation': 'Veterans Affairs Long Beach Healthcare System, Long Beach, California.'}, {'ForeName': 'Murat', 'Initials': 'M', 'LastName': 'Sezer', 'Affiliation': 'Istanbul University, Istanbul Faculty of Medicine, Istanbul, Turkey.'}, {'ForeName': 'Andrew S P', 'Initials': 'ASP', 'LastName': 'Sharp', 'Affiliation': 'Royal Devon and Exeter Hospital, Exeter, England.'}, {'ForeName': 'Jasvindar', 'Initials': 'J', 'LastName': 'Singh', 'Affiliation': 'Washington University School of Medicine in St Louis, St Louis, Missouri.'}, {'ForeName': 'Hiroaki', 'Initials': 'H', 'LastName': 'Takashima', 'Affiliation': 'Aichi Medical University Hospital, Aichi, Japan.'}, {'ForeName': 'Suneel', 'Initials': 'S', 'LastName': 'Talwar', 'Affiliation': 'Royal Bournemouth General Hospital, Bournemouth, England.'}, {'ForeName': 'Nobuhiro', 'Initials': 'N', 'LastName': 'Tanaka', 'Affiliation': 'Tokyo Medical University, Tokyo, Japan.'}, {'ForeName': 'Kare', 'Initials': 'K', 'LastName': 'Tang', 'Affiliation': 'Essex Cardiothoracic Centre, Basildon, England.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Van Belle', 'Affiliation': 'Institut Coeur Poumon, Lille University Hospital, Lille, France.'}, {'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'van Royen', 'Affiliation': 'VU University Medical Center, Amsterdam, the Netherlands.'}, {'ForeName': 'Hugo', 'Initials': 'H', 'LastName': 'Vinhas', 'Affiliation': 'Hospital Garcia de Horta, Lisbon, Portugal.'}, {'ForeName': 'Christiaan J', 'Initials': 'CJ', 'LastName': 'Vrints', 'Affiliation': 'Antwerp University Hospital, Antwerp, Belgium.'}, {'ForeName': 'Darren', 'Initials': 'D', 'LastName': 'Walters', 'Affiliation': 'Prince Charles Hospital, Brisbane, Queensland, Australia.'}, {'ForeName': 'Hiroyoshi', 'Initials': 'H', 'LastName': 'Yokoi', 'Affiliation': 'Fukuoka Sannou Hospital, Fukuoka, Japan.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Samuels', 'Affiliation': 'Cedars-Sinai Heart Institute, Los Angeles, California.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Buller', 'Affiliation': 'St Michaels Hospital, Toronto, Ontario, Canada.'}, {'ForeName': 'Manesh R', 'Initials': 'MR', 'LastName': 'Patel', 'Affiliation': 'Duke University, Durham, North Carolina.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Serruys', 'Affiliation': 'Hammersmith Hospital, Imperial College London, London, England.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Escaned', 'Affiliation': 'Hospital Clínico San Carlos, IDISSC and Universidad Complutense de Madrid, Madrid, Spain.'}, {'ForeName': 'Justin E', 'Initials': 'JE', 'LastName': 'Davies', 'Affiliation': 'Hammersmith Hospital, Imperial College London, London, England.'}]",JAMA cardiology,['10.1001/jamacardio.2019.2298'] 930,31297582,"Comparison of Topical, Systemic, and Combined Therapy with Steroids on Idiopathic Granulomatous Mastitis: A Prospective Randomized Study.","BACKGROUND Idiopathic granulomatous mastitis (IGM) is a benign disorder of the breast, for which the optimal treatment modality remains missing. METHODS A total of 124 patients with a histopathologically proven diagnosis of IGM were enrolled in a prospective, randomized parallel arm study. Patients were treated with topical steroids in Group T (n: 42), systemic steroids (0.8 mg/kg/day peroral) in Group S (n: 42), and combined steroids (0.4 mg/kg/day peroral + topical) in Group C (n: 40). Compliance with the therapy, response to the therapy, the duration of therapy, side effects and the recurrence rates were compared. RESULTS Sixteen patients did not comply with the treatment, and the highest ratio of compliance with therapy was seen in Group T (p < 0.05). Complete clinical regression (CCR) was observed in 90 (83.3%) patients. Response to the treatment (RT) was evaluated radiologically and observed in 89.8% of the patients. There was no statistically significant difference between groups regarding CCR, RT and the recurrence rate. The longest duration of therapy was observed in Group T (22 ± 9.1-week), whereas the shortest was observed in Group S (11.7 ± 5.5-week) (p < 0.001). The systemic side effects were significantly lower in Group T in comparison with Groups S and C (2.4% vs. 38.2% and 30.3%, respectively) (p < 0.001). CONCLUSIONS The efficiency of the treatment was similar for all groups, both clinically and radiologically. Although the duration of therapy was longer in Group T, the lack of systemic side effects increased the compliance of the patients with the therapy. Therefore, topical steroids would be among first-line treatment options of IGM.",2019,"The systemic side effects were significantly lower in Group T in comparison with Groups S and C (2.4% vs. 38.2% and 30.3%, respectively)","['Idiopathic Granulomatous Mastitis', '124 patients with a histopathologically proven diagnosis of IGM']","['combined steroids (0.4\xa0mg/kg/day peroral\u2009+\u2009topical', 'systemic steroids', 'topical steroids', 'Topical, Systemic, and Combined Therapy with Steroids']","['highest ratio of compliance with therapy', 'Complete clinical regression (CCR', 'longest duration of therapy', 'duration of therapy, side effects and the recurrence rates', 'systemic side effects', 'CCR, RT and the recurrence rate']","[{'cui': 'C4552494', 'cui_str': 'Idiopathic granulomatous mastitis'}, {'cui': 'C4517553', 'cui_str': '124 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0456369', 'cui_str': 'Proven (qualifier value)'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0020861', 'cui_str': 'IgM'}]","[{'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0038317', 'cui_str': 'Steroids'}, {'cui': 'C4517457', 'cui_str': 'Zero point four'}, {'cui': 'C3665414', 'cui_str': 'mg/kg/day'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0033972', 'cui_str': 'Psychotherapy, Multiple'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0684321', 'cui_str': 'Regression'}, {'cui': 'C0439591', 'cui_str': 'Long duration (qualifier value)'}, {'cui': 'C0444917', 'cui_str': 'Duration of therapy (qualifier value)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}]",124.0,0.0170221,"The systemic side effects were significantly lower in Group T in comparison with Groups S and C (2.4% vs. 38.2% and 30.3%, respectively)","[{'ForeName': 'Kenan', 'Initials': 'K', 'LastName': 'Çetin', 'Affiliation': 'Department of General Surgery, University of Health Sciences, Kartal Dr. Lutfi Kirdar Training and Research Hospital, Istanbul, Turkey. drkenancetin@hotmail.com.'}, {'ForeName': 'Hasan E', 'Initials': 'HE', 'LastName': 'Sıkar', 'Affiliation': 'Department of General Surgery, University of Health Sciences, Kartal Dr. Lutfi Kirdar Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Nuri E', 'Initials': 'NE', 'LastName': 'Göret', 'Affiliation': 'Department of General Surgery, University of Health Sciences, Kartal Dr. Lutfi Kirdar Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Günay', 'Initials': 'G', 'LastName': 'Rona', 'Affiliation': 'Department of Radiology, University of Health Sciences, Kartal Dr. Lutfi Kirdar Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Nagehan Ö', 'Initials': 'NÖ', 'LastName': 'Barışık', 'Affiliation': 'Department of Pathology, University of Health Sciences, Kartal Dr. Lutfi Kirdar Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Hasan F', 'Initials': 'HF', 'LastName': 'Küçük', 'Affiliation': 'Department of General Surgery, University of Health Sciences, Kartal Dr. Lutfi Kirdar Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Bahadır M', 'Initials': 'BM', 'LastName': 'Gulluoglu', 'Affiliation': 'Breast and Endocrine Surgery Unit, Department of General Surgery, Marmara University School of Medicine, 34899, Pendik, Istanbul, Turkey.'}]",World journal of surgery,['10.1007/s00268-019-05084-x'] 931,31837726,The effects of varied practice on the oral reading fluency of fourth-grade students.,"To improve oral reading fluency rate and promote its generalization to unpracticed texts, this study investigated a Varied Practice approach that involved passages with a high proportion of overlapping words (M = 85% unique word overlap). Fourth graders were randomly assigned either to the Varied Practice treatment (n = 405), where they read three different passages one time each, or the Repeated Reading comparison (n = 422), in which they read the same passage three times each. Both groups read with a partner for about 20 min, 3-4 times per week, over an average 12 weeks (30 total sessions). Results indicated that students in Varied Practice demonstrated significantly better fluency outcomes than students in Repeated Reading, but both groups demonstrated growth near the 90th percentile. Results of a quantile regression revealed that low-to-middle achievers benefited from Varied Practice the most. Overall, the findings suggest fluency approaches rooted in statistical learning hold promise as an alternative to approaches focused on practicing words in redundant contexts.",2019,"Results indicated that students in Varied Practice demonstrated significantly better fluency outcomes than students in Repeated Reading, but both groups demonstrated growth near the 90th percentile.",['fourth-grade students'],['Varied Practice treatment'],"['fluency outcomes', 'oral reading fluency rate']","[{'cui': 'C0205438', 'cui_str': 'Fourth (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}]",422.0,0.0164961,"Results indicated that students in Varied Practice demonstrated significantly better fluency outcomes than students in Repeated Reading, but both groups demonstrated growth near the 90th percentile.","[{'ForeName': 'Deborah K', 'Initials': 'DK', 'LastName': 'Reed', 'Affiliation': 'Iowa Reading Research Center, University of Iowa, USA. Electronic address: deborah-reed@uiowa.edu.'}, {'ForeName': 'Leah M', 'Initials': 'LM', 'LastName': 'Zimmermann', 'Affiliation': 'Iowa Reading Research Center, University of Iowa, USA.'}, {'ForeName': 'Adam J', 'Initials': 'AJ', 'LastName': 'Reeger', 'Affiliation': 'Iowa Reading Research Center, University of Iowa, USA.'}, {'ForeName': 'Ariel M', 'Initials': 'AM', 'LastName': 'Aloe', 'Affiliation': 'Iowa Reading Research Center, University of Iowa, USA. Electronic address: ariel-aloe@uiowa.edu.'}]",Journal of school psychology,['10.1016/j.jsp.2019.10.003'] 932,30244209,Development of the individualised Comparative Effectiveness of Models Optimizing Patient Safety and Resident Education (iCOMPARE) trial: a protocol summary of a national cluster-randomised trial of resident duty hour policies in internal medicine.,"INTRODUCTION Medical trainees' duty hours have received attention globally; restrictions in Europe, New Zealand and some Canadian provinces are much lower than the 80 hours per week enforced in USA. In USA, resident duty hours have been implemented without evidence simultaneously reflecting competing concerns about patient safety and physician education. The objective is to prospectively evaluate the implications of alternative resident duty hour rules for patient safety, trainee education and intern sleep and alertness. METHODS AND ANALYSIS 63 US internal medicine training programmes were randomly assigned 1:1 to the 2011 Accreditation Council for Graduate Medical Education resident duty hour rules or to rules more flexible in intern shift length and number of hours off between shifts for academic year 2015-2016. The primary outcome is calculated for each programme as the difference in 30-day mortality rate among Medicare beneficiaries with any of several prespecified principal diagnoses in the intervention year minus 30-day mortality in the preintervention year among Medicare beneficiaries with any of several prespecified principal diagnoses. Additional safety outcomes include readmission rates, prolonged length of stay and costs. Measures derived from trainees' and faculty responses to surveys and from time-motion studies of interns compare the educational experiences of residents. Measures derived from wrist actigraphy, subjective ratings and psychomotor vigilance testing compare the sleep and alertness of interns. Differences between duty hour groups in outcomes will be assessed by intention-to-treat analyses. ETHICS AND DISSEMINATION The University of Pennsylvania Institutional Review Board (IRB) approved the protocol and served as the IRB of record for 40 programmes that agreed to sign an Institutional Affiliation Agreement. Twenty-three programmes opted for a local review process. TRIAL REGISTRATION NUMBER NCT02274818; Pre-results.",2018,"Medical trainees' duty hours have received attention globally; restrictions in Europe, New Zealand and some Canadian provinces are much lower than the 80 hours per week enforced in USA.",['63 US internal medicine training programmes'],['2011 Accreditation Council for Graduate Medical Education resident duty hour rules or to rules more flexible in intern shift length and number of hours off between shifts for academic year 2015-2016'],"['wrist actigraphy, subjective ratings and psychomotor vigilance testing compare the sleep and alertness of interns', '30-day mortality', 'readmission rates, prolonged length of stay and costs', '30-day mortality rate']","[{'cui': 'C0021782', 'cui_str': 'Internal Medicine'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0000941', 'cui_str': 'Accreditation'}, {'cui': 'C0013633', 'cui_str': 'Education, Medical, Graduate'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C0443220', 'cui_str': 'Flexible (qualifier value)'}, {'cui': 'C0333051', 'cui_str': 'Shift (morphologic abnormality)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0043262', 'cui_str': 'Wrist'}, {'cui': 'C1171301', 'cui_str': 'Actigraphy'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0439590', 'cui_str': 'Prolonged (qualifier value)'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0205848', 'cui_str': 'Death Rate'}]",,0.0985247,"Medical trainees' duty hours have received attention globally; restrictions in Europe, New Zealand and some Canadian provinces are much lower than the 80 hours per week enforced in USA.","[{'ForeName': 'Judy A', 'Initials': 'JA', 'LastName': 'Shea', 'Affiliation': 'Department of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Jeffrey H', 'Initials': 'JH', 'LastName': 'Silber', 'Affiliation': ""Department of Pediatrics, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, USA.""}, {'ForeName': 'Sanjay V', 'Initials': 'SV', 'LastName': 'Desai', 'Affiliation': 'Department of Medicine, The Johns Hopkins University, Baltimore, Maryland, USA.'}, {'ForeName': 'David F', 'Initials': 'DF', 'LastName': 'Dinges', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'Bellini', 'Affiliation': 'Department of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Tonascia', 'Affiliation': 'Department of Biostatistics, The Johns Hopkins University, Baltimore, Maryland, USA.'}, {'ForeName': 'Alice L', 'Initials': 'AL', 'LastName': 'Sternberg', 'Affiliation': 'Department of Epidemiology, The Johns Hopkins University, Baltimore, Maryland, USA.'}, {'ForeName': 'Dylan S', 'Initials': 'DS', 'LastName': 'Small', 'Affiliation': 'Wharton Statistics Department, University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Shade', 'Affiliation': 'Department of Epidemiology, The Johns Hopkins University, Baltimore, Maryland, USA.'}, {'ForeName': 'Joel Thorp', 'Initials': 'JT', 'LastName': 'Katz', 'Affiliation': ""Department of Medicine, Brigham and Women's Hospital, Boston, Massachusetts, USA.""}, {'ForeName': 'Mathias', 'Initials': 'M', 'LastName': 'Basner', 'Affiliation': 'Department of Psychiatry, University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Krisda H', 'Initials': 'KH', 'LastName': 'Chaiyachati', 'Affiliation': 'Department of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Orit', 'Initials': 'O', 'LastName': 'Even-Shoshan', 'Affiliation': ""Department of Pediatrics, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, USA.""}, {'ForeName': 'David Westfall', 'Initials': 'DW', 'LastName': 'Bates', 'Affiliation': ""Department of Medicine, Brigham and Women's Hospital, Boston, Massachusetts, USA.""}, {'ForeName': 'Kevin G', 'Initials': 'KG', 'LastName': 'Volpp', 'Affiliation': 'Corporal Michael J. Crescenz VA Medical Center, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Asch', 'Affiliation': 'Department of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ open,['10.1136/bmjopen-2018-021711'] 933,31281624,Impact of peroral cholangioscopy on the management of indeterminate biliary conditions: a multicentre prospective trial.,"Background and aims Single-operator cholangioscopy (SOC) can help diagnose biliopancreatic conditions. The impact of SOC on patient outcome has never been specifically addressed. Patients and methods Consecutive patients bearing indeterminate biliary strictures (IDBS), or primary sclerosing cholangitis (PSC) with suspected cholangiocarcinoma, were included. Patients with IDBS had at least one previous inconclusive endoscopic retrograde cholangio pancreatography (ERCP) + cytology. Primary endpoint was the difference in adequacy of management planned before and after SOC with regard to final diagnosis obtained after surgery or 24 months follow-up. Design Prospective open-label multicentre trial. Results 61 patients were included (IDBS: 48; PSC: 13); 70.5% had a benign lesion (IDBS 66.7%, PSC 84.6%). The management adequacy rate was significantly higher after SOC than before SOC overall (p<10 -5 ), in IDBS (p<0.001) and PSC (p<0.05) patients. SOC induced changes in the management of the majority of patients in all groups (60.3%). The overall sensitivity of combined visual impression and biopsy ranged from 52% to 63.6% depending on investigator or independent expert rating (κ 0.92-0.96), whereas specificity, positive and negative predictive values of SOC were, respectively, 100%, 100% and 83.6%. Patient management observed at the end of follow-up was consistent with that anticipated after SOC in 88.5% overall. Conclusion Despite a moderate sensitivity for the diagnosis of malignancy, SOC has a dramatic impact on the management of patients with IDBS and PSC with suspected carcinoma. Cholangioscopy might be implemented in the workup of selected patients with challenging diagnosis, when a significant impact on outcome (essentially resection vs conservative management) is to be expected.",2019,"The management adequacy rate was significantly higher after SOC than before SOC overall (p<10 -5 ), in IDBS (p<0.001) and PSC (p<0.05) patients.","['Patients and methods\n\n\nConsecutive patients bearing indeterminate biliary strictures (IDBS), or primary sclerosing cholangitis (PSC) with suspected cholangiocarcinoma, were included', '61 patients were included (IDBS: 48; PSC: 13); 70.5% had a benign lesion (IDBS 66.7%, PSC 84.6', 'patients with IDBS and PSC with suspected carcinoma', 'Patients with IDBS had at least one previous inconclusive endoscopic retrograde cholangio pancreatography (ERCP) + cytology', 'indeterminate biliary conditions']","['peroral cholangioscopy', ' and aims\n\n\nSingle-operator cholangioscopy (SOC']","['management adequacy rate', 'overall sensitivity of combined visual impression and biopsy', 'adequacy of management planned before and after SOC with regard to final diagnosis', 'specificity, positive and negative predictive values of SOC']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0205258', 'cui_str': 'Indeterminate (qualifier value)'}, {'cui': 'C0597984', 'cui_str': 'Biliary stricture (disorder)'}, {'cui': 'C0566602', 'cui_str': 'Primary sclerosing cholangitis (disorder)'}, {'cui': 'C0750491', 'cui_str': 'Suspected (qualifier value)'}, {'cui': 'C0206698', 'cui_str': 'Cholangiocellular Carcinoma'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205183', 'cui_str': 'Benign (qualifier value)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C4517843', 'cui_str': '66.7 (qualifier value)'}, {'cui': 'C0007097', 'cui_str': 'Epithelioma'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C1629507', 'cui_str': 'Inconclusive'}, {'cui': 'C0439784', 'cui_str': 'Retrograde direction (qualifier value)'}, {'cui': 'C0581480', 'cui_str': 'Pancreatic contrast procedure (procedure)'}, {'cui': 'C0010820', 'cui_str': 'cytology'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C0940834', 'cui_str': 'Cholangioscopy (procedure)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C0332144', 'cui_str': 'Final diagnosis (discharge) (contextual qualifier) (qualifier value)'}, {'cui': 'C0037791', 'cui_str': 'Specificity'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",61.0,0.0633077,"The management adequacy rate was significantly higher after SOC than before SOC overall (p<10 -5 ), in IDBS (p<0.001) and PSC (p<0.05) patients.","[{'ForeName': 'Frederic', 'Initials': 'F', 'LastName': 'Prat', 'Affiliation': 'Department of Gastroenterology, Assistance Publique Hopitaux de Paris, Paris-Descartes University, Paris, France.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Leblanc', 'Affiliation': 'Department of Gastroenterology, Assistance Publique Hopitaux de Paris, Paris-Descartes University, Paris, France.'}, {'ForeName': 'Frantz', 'Initials': 'F', 'LastName': 'Foissac', 'Affiliation': 'Clinical Research Unit, Cochin Hospital, Paris, France.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Ponchon', 'Affiliation': 'Gastroenterology, Hopital Edouard Herriot, Lyon, France.'}, {'ForeName': 'René', 'Initials': 'R', 'LastName': 'Laugier', 'Affiliation': 'Gastroenterology, Assistance Publique Hopitaux de Marseille, Marseille, France.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Bichard', 'Affiliation': 'Digestive Endoscopy Unit, Centre Hospitalier Universitaire de Grenoble, Grenoble, France.'}, {'ForeName': 'Frédérique', 'Initials': 'F', 'LastName': 'Maire', 'Affiliation': 'Gastroenterology, Hopital Beaujon, Clichy, France.'}, {'ForeName': 'Dimitri', 'Initials': 'D', 'LastName': 'Coumaros', 'Affiliation': 'IRCAD/EITS, University Hospital, Strasbourg, France.'}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Charachon', 'Affiliation': 'Endoscopy, Fondation Princesse Grace de Monaco, Monaco, Monaco.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Vedrenne', 'Affiliation': 'Groupe Hospitalier de la Region de Mulhouse et Sud Alsace, Mulhouse, France.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Boytchev', 'Affiliation': 'Hopital Bicetre, Le Kremlin-Bicetre, France.'}, {'ForeName': 'Stanislas', 'Initials': 'S', 'LastName': 'Chaussade', 'Affiliation': 'Gastroenterology, Assistance Publique Hopitaux de Paris, Paris, France.'}, {'ForeName': 'Nadira', 'Initials': 'N', 'LastName': 'Kaddour', 'Affiliation': 'Clinical Research Unit, Hopital Cochin, Paris, France.'}, {'ForeName': 'Arthur', 'Initials': 'A', 'LastName': 'Laquière', 'Affiliation': 'Gastroenterology and Endoscopy Unit, Hopital st joseph, Marseille, France.'}, {'ForeName': 'Sèbastien', 'Initials': 'S', 'LastName': 'Gaujoux', 'Affiliation': 'Department of Surgery, Assistance Publique - Hopitaux de Paris, Paris, France.'}]",Frontline gastroenterology,['10.1136/flgastro-2018-100985'] 934,32116576,Transcutaneous Electrical Spinal Cord Neuromodulator (TESCoN) Improves Symptoms of Overactive Bladder.,"Neuromodulation is a therapeutic technique that is well-established in the treatment of idiopathic Lower urinary tract (LUT) dysfunction such as overactive bladder (OAB). We have recently developed a novel neuromodulation approach, Transcutaneous Electrical Spinal Cord Neuromodulation (TESCoN) and demonstrated its acute effects on LUT dysfunction after spinal cord injury (SCI) during urodynamic studies. We found that TESCoN can promote urinary storage and induce urinary voiding when delivered during urodynamic studies. The objective of this study was to determine whether TESCoN can retrain the spinal neural networks to induce chronic improvement in the LUT, such that positive changes can persist even in the absence of stimulation. In addition, we wished to examine the effect of TESCoN on LUT dysfunction due to multiple pathologies. To achieve this objective, 14 patients [SCI = 5, stroke = 5, multiple sclerosis (MS) = 3, and idiopathic OAB (iOAB) = 1] completed 24 sessions of TESCoN over the course of 8 weeks. Patients completed urodynamic studies before and after undergoing TESCoN therapy. Additionally, each subject completed a voiding diary and the Neurogenic Bladder Symptom Score questionnaire before and after receiving TESCoN therapy. We found that TESCoN led to decreased detrusor overactivity, improved continence, and enhanced LUT sensation across the different pathologies underlying LUT dysfunction. This study serves as a pilot in preparation for a rigorous randomized placebo-controlled trial designed to demonstrate the effect of TESCoN on LUT function in neurogenic and non-neurogenic conditions. New And Noteworthy Non-Surgical modality to reduce incidence of urinary incontinence and improve neurogenic bladder symptom scores (NBSS) in individuals with neurogenic bladder due to spinal cord injury or stroke.",2020,Non-Surgical modality to reduce incidence of urinary incontinence and improve neurogenic bladder symptom scores (NBSS) in individuals with neurogenic bladder due to spinal cord injury or stroke.,"['individuals with neurogenic bladder due to spinal cord injury or stroke', '14 patients [SCI = 5, stroke = 5, multiple sclerosis (MS) = 3, and idiopathic OAB (iOAB) = 1] completed 24 sessions of']","['placebo', 'Transcutaneous Electrical Spinal Cord Neuromodulator (TESCoN', 'TESCoN', 'Transcutaneous Electrical Spinal Cord Neuromodulation (TESCoN']","['neurogenic bladder symptom scores (NBSS', 'urinary storage and induce urinary voiding', 'Symptoms of Overactive Bladder', 'voiding diary and the Neurogenic Bladder Symptom Score questionnaire', 'detrusor overactivity, improved continence, and enhanced LUT sensation']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0005697', 'cui_str': 'Neurogenic Bladder'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0037929', 'cui_str': 'Spinal Cord Trauma'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0026769', 'cui_str': 'MS (Multiple Sclerosis)'}, {'cui': 'C1608429', 'cui_str': 'Idiopathic (IPAH)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0442828', 'cui_str': 'Electrical (qualifier value)'}, {'cui': 'C0037925', 'cui_str': 'Myelon'}, {'cui': 'C0949370', 'cui_str': 'Neuromodulators'}]","[{'cui': 'C0005697', 'cui_str': 'Neurogenic Bladder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1698986', 'cui_str': 'Storage (procedure)'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0878773', 'cui_str': 'Overactive Bladder'}, {'cui': 'C0376660', 'cui_str': 'Diary'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1536696', 'cui_str': 'Overactivity'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0036658', 'cui_str': 'Sensory Function'}]",,0.0793328,Non-Surgical modality to reduce incidence of urinary incontinence and improve neurogenic bladder symptom scores (NBSS) in individuals with neurogenic bladder due to spinal cord injury or stroke.,"[{'ForeName': 'Evgeniy', 'Initials': 'E', 'LastName': 'Kreydin', 'Affiliation': 'Institute of Urology, Keck School of Medicine, University of Southern California, Los Angeles, CA, United States.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Zhong', 'Affiliation': 'Rancho Research Institute, Rancho Los Amigos National Rehabilitation Center, Downey, CA, United States.'}, {'ForeName': 'Kyle', 'Initials': 'K', 'LastName': 'Latack', 'Affiliation': 'Institute of Urology, Keck School of Medicine, University of Southern California, Los Angeles, CA, United States.'}, {'ForeName': 'Shirley', 'Initials': 'S', 'LastName': 'Ye', 'Affiliation': 'Institute of Urology, Keck School of Medicine, University of Southern California, Los Angeles, CA, United States.'}, {'ForeName': 'V Reggie', 'Initials': 'VR', 'LastName': 'Edgerton', 'Affiliation': 'Rancho Research Institute, Rancho Los Amigos National Rehabilitation Center, Downey, CA, United States.'}, {'ForeName': 'Parag', 'Initials': 'P', 'LastName': 'Gad', 'Affiliation': 'Institute of Urology, Keck School of Medicine, University of Southern California, Los Angeles, CA, United States.'}]",Frontiers in systems neuroscience,['10.3389/fnsys.2020.00001'] 935,31289452,Pre-radiotherapy daily exercise training in non-small cell lung cancer: A feasibility study.,"Aim To examine the feasibility of an individual, supervised, structured moderate-to-high intensity cycle ergometer exercise training immediately before radiotherapy in patients undergoing concomitant chemoradiotherapy for locally advanced non-small cell lung cancer (NSCLC). Background Lung cancer is the most common form of cancer. Despite significant advancements in therapy and supportive care it is still the leading cause of cancer-related death worldwide. Materials and methods Randomized controlled study design; patients with NSCLC receiving concomitant chemoradiotherapy were recruited and randomly assigned to either the exercise (EXE) or the control (CON) group. Exercise training consisted of 20 min moderate-to-high intensity aerobic interval training 5 times per week (Mon-Fri) prior to radiotherapy. Secondary outcomes were assessed at baseline and after 7 weeks: peak oxygen consumption (VO 2peak ), functional capacity (6MWD), pulmonary function (FEV1), psychosocial parameters (quality of life (FACT-L), anxiety and depression (HADS)) and cancer-related side effects (reported daily). Results Fifteen patients were included. All patients completed a baseline test, while 13 patients were eligible for a posttest. The recruiting rate was 44.1% and the overall attendance rate to exercise was 90.0% with an adherence rate to full exercise participation of 88.1%. No adverse events or any unexpected reactions were observed during the exercise sessions. No significant differences were observed within or between groups from baseline to post intervention in any of the secondary outcomes. Conclusion This study demonstrated 'proof of principle' that daily moderate-to-high intensity cycle ergometer exercise was feasible, safe and well tolerated among newly diagnosed patients with locally advanced NSCLC undergoing concomitant chemoradiotherapy. Larger randomized controlled trials are warranted.",2019,No adverse events or any unexpected reactions were observed during the exercise sessions.,"['Fifteen patients were included', 'non-small cell lung cancer', ' patients with NSCLC receiving concomitant chemoradiotherapy', 'All patients completed a baseline test, while 13 patients were eligible for a posttest', 'newly diagnosed patients with locally advanced NSCLC undergoing concomitant chemoradiotherapy', 'patients undergoing concomitant chemoradiotherapy for locally advanced non-small cell lung cancer (NSCLC']","['Exercise training consisted of 20\xa0min moderate-to-high intensity aerobic interval training 5 times per week (Mon-Fri) prior to radiotherapy', 'daily moderate-to-high intensity cycle ergometer exercise', 'exercise (EXE) or the control (CON', 'Pre-radiotherapy daily exercise training', 'individual, supervised, structured moderate-to-high intensity cycle ergometer exercise training immediately before radiotherapy']","['safe and well tolerated', 'peak oxygen consumption (VO 2peak ), functional capacity (6MWD), pulmonary function (FEV1), psychosocial parameters (quality of life (FACT-L), anxiety and depression (HADS)) and cancer-related side effects (reported daily', 'overall attendance rate to exercise']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}, {'cui': 'C3178775', 'cui_str': 'Concomitant Radiochemotherapy'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}]","[{'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C1305742', 'cui_str': 'Oxygen consumption'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0034380'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]",15.0,0.147945,No adverse events or any unexpected reactions were observed during the exercise sessions.,"[{'ForeName': 'Trine', 'Initials': 'T', 'LastName': 'Egegaard', 'Affiliation': 'The University Hospitals for Health Sciences, University Hospital of Copenhagen, Denmark.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Rohold', 'Affiliation': 'The University Hospitals for Health Sciences, University Hospital of Copenhagen, Denmark.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Lillelund', 'Affiliation': 'The University Hospitals for Health Sciences, University Hospital of Copenhagen, Denmark.'}, {'ForeName': 'Gitte', 'Initials': 'G', 'LastName': 'Persson', 'Affiliation': 'Department of Oncology, University Hospital of Copenhagen, Denmark.'}, {'ForeName': 'Morten', 'Initials': 'M', 'LastName': 'Quist', 'Affiliation': 'The University Hospitals for Health Sciences, University Hospital of Copenhagen, Denmark.'}]",Reports of practical oncology and radiotherapy : journal of Greatpoland Cancer Center in Poznan and Polish Society of Radiation Oncology,['10.1016/j.rpor.2019.06.003'] 936,31837906,"Does intramuscular ondansetron have an effect on intramuscular ketamine-associated vomiting in children? A prospective, randomized, double blind, controlled study.","OBJECTIVE This study was conducted to determine the effect of intramuscular ondansetron on ketamine-associated vomiting in children undergoing procedural sedation. METHODS This randomized, double-blind, placebo-controlled, parallel-group clinical trial was conducted at the emergency departments of two university-affiliated tertiary care hospitals. Eligible participants included all 6-month to 16-year-old children who received IM ketamine for PSA in the ED. A convenience sampling approach was used and a block randomization method was applied (blocks of four) using a computer-generated random sequence. Patients received ketamine 4 mg/kg or ketamine 4 mg/kg plus ondansetron 0.1 mg/kg intramuscularly. All findings including the occurrence of vomiting and its frequency were then recorded in the data collection sheets. RESULTS Of 56 patients who received ondansetron plus ketamin, 7 (12.5%) and 1 (1.8%) experienced vomiting during recovery and before discharge and Of 65 patients in the control group, 14 (21.5%) and 6 (9.2%) experienced vomiting during recovery and before discharge, respectively. The observed differences in the rates of vomiting during recovery and at discharge were statistically significant between the two groups (P-value of 0.03 and <0.001, respectively). CONCLUSION Intramuscular ondansetron is effective in controlling ketamine-associated vomiting.",2020,"The observed differences in the rates of vomiting during recovery and at discharge were statistically significant between the two groups (P-value of 0.03 and <0.001, respectively). ","['children undergoing procedural sedation', 'emergency departments of two university-affiliated tertiary care hospitals', 'Eligible participants included all 6-month to 16-year-old children who received']","['placebo', 'ketamine', 'IM ketamine', 'Intramuscular ondansetron', 'ketamine 4\u202fmg/kg or ketamine 4\u202fmg/kg plus ondansetron 0.1\u202fmg/kg intramuscularly', 'ondansetron', 'ondansetron plus ketamin']","['vomiting', 'occurrence of vomiting and its frequency', 'rates of vomiting']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0337954', 'cui_str': 'Tertiary care hospital (environment)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0442117', 'cui_str': 'Intramuscular (qualifier value)'}, {'cui': 'C0061851', 'cui_str': 'Ondansetron'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C4517420', 'cui_str': 'Zero point one'}]","[{'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}]",65.0,0.545507,"The observed differences in the rates of vomiting during recovery and at discharge were statistically significant between the two groups (P-value of 0.03 and <0.001, respectively). ","[{'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Nejati', 'Affiliation': 'Department of Emergency Medicine, Tehran University of Medical Sciences, Tehran, Iran. Electronic address: anejati@tumsac.ir.'}, {'ForeName': 'Seyyedhossein Seyyedhoseini', 'Initials': 'SS', 'LastName': 'Davarani', 'Affiliation': 'Department of Emergency Medicine, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohammad Taghi', 'Initials': 'MT', 'LastName': 'Talebian', 'Affiliation': 'Department of Emergency Medicine, Tehran University of Medical Sciences, Tehran, Iran. Electronic address: mtalebian@tums.ac.ir.'}, {'ForeName': 'Firouzi', 'Initials': 'F', 'LastName': 'Hossein', 'Affiliation': 'Department of Paediatrics, Ramsar Campus, Mazandaran University of Medical Science, Mazandaran, Iran. Electronic address: firoozihosein@mazums.ac.ir.'}, {'ForeName': 'Hamideh', 'Initials': 'H', 'LastName': 'Akbari', 'Affiliation': 'Department of Emergency Medicine, Tehran University of Medical Sciences, Tehran, Iran. Electronic address: H-akbari@sina.tums.ac.ir.'}]",The American journal of emergency medicine,['10.1016/j.ajem.2019.158445'] 937,31273755,Interventions for treating neuropathic pain in people with sickle cell disease.,"BACKGROUND Pain is the hallmark of sickle cell disease (SCD) and it can be severe, frequent and unpredictable. Although nociceptive pain is more common, at times, people with SCD may have neuropathic pain. The latter can occur due to peripheral or central nerve injury. This review is focused on identifying treatment of only painful sensory neuropathy in people with SCD. OBJECTIVES To determine the effectiveness and safety of any pharmacological or non-pharmacological therapies for treating neuropathic pain in people with SCD. SEARCH METHODS We searched the Cochrane Cystic Fibrosis and Genetic Disorders Group's Haemoglobinopathies Trials Register, compiled from electronic database searches and handsearching of journals and conference abstract books. We also searched trial registries, the reference lists of relevant articles and reviews and contacted experts in the field.Date of last search: 31 January 2019. SELECTION CRITERIA Randomised controlled trials (RCTs) (parallel or cross-over in design), quasi-RCTs of pharmacological or non-pharmacological therapies for treating neuropathic pain in people with SCD compared to placebo or another intervention in any category (i.e. pharmacological or non-pharmacological). DATA COLLECTION AND ANALYSIS Two review authors independently assessed all trials identified by the searches and extracted relevant data. Two authors independently assessed the risk of bias in the selected trials using the Cochrane risk of bias tool. Two review authors independently rated the quality of the evidence for each outcome using the GRADE guidelines. MAIN RESULTS One RCT of 22 participants with SCD, conducted in the USA was included in this review. Participants were randomly assigned to either pregabalin (n = 11) or placebo (n = 11). Oral pregabalin was administered at an initial dose of 75 mg twice daily. The drug was titrated at increments of 75 mg to a maximum of 600 mg daily or decreased by 75 mg per day if necessary, based on clinical presentation and pain level. Neuropathic pain was assessed using self-reports on the Leeds Assessment of Neuropathic Symptoms and Signs (S-LANNS) scale and the Neuropathic Pain Symptom Inventory (NPSI), where higher scores were indicative of more pain. Outcomes included self-reported pain, quality of life and withdrawal due to adverse effects measured at baseline and monthly for three months post-intervention. The overall risk of bias was low with a high risk of bias due to attrition.In relation to this reviews primary outcomes, for self-reported neuropathic pain relief, given the paucity of data, we are very uncertain whether there is a difference between the pregabalin and placebo groups at the end of three months as measured by the S-LANSS scale, mean difference (MD) -2.00 (95% confidence interval (CI) -9.18 to 5.18), or the NPSI scale, MD -11.10 (95% CI -33.97 to 11.77) (very low-quality evidence). There was no report of 'Patient Global Impression of Change' in the included trial.Although the mean quality of life scores (Short Form-36) at three months showed small increases in seven of the eight domains post-intervention in the pregabalin group as compared to the placebo group, this was very low-quality evidence and we are very uncertain whether pregabalin increases quality of life. Neither of our pre-defined outcomes of 'time to improvement of symptoms' or 'changes in sleep quality', were measured in the included trial.While treatment-related adverse effects appeared higher in pregabalin group than the placebo group at three months, this was very low-quality evidence and we are very uncertain whether there is a difference, RR 1.33 (95% CI 0.39 to 4.62) (very low-quality evidence). There was one withdrawal for adverse effects in the pregabalin group while three people withdrew or dropped out from the placebo group due to adverse effects and complications and hospitalisation related to SCD. AUTHORS' CONCLUSIONS The included trial provided very low-quality evidence. Self-reported pain relief was greater in the pregabalin group compared to the placebo control group but only using the S-LANSS scale and we are very unsure whether there is a difference. While the pregabalin group tended to have improved quality of life over the duration of the trial, this was very low-quality evidence and we are uncertain whether there is a difference. Adverse effects and withdrawals were similar across the treatment and placebo control group in trial. There are both insufficient trials addressing this review question and insufficient outcomes addressed in the single included RCT. Therefore, there is still a significant gap in evidence on interventions for neuropathic pain in people with SCD.",2019,Self-reported pain relief was greater in the pregabalin group compared to the placebo control group but only using the S-LANSS scale and we are very unsure whether there is a difference.,"['22 participants with SCD', 'people with SCD', 'people with sickle cell disease']","['placebo', 'Oral pregabalin', 'pregabalin', 'pharmacological or non-pharmacological therapies', 'quasi-RCTs of pharmacological or non-pharmacological therapies']","['self-reported pain, quality of life and withdrawal due to adverse effects', 'adverse effects and complications and hospitalisation', 'Neuropathic Symptoms and Signs (S-LANNS) scale and the Neuropathic Pain Symptom Inventory (NPSI', 'mean quality of life scores', 'adverse effects', 'S-LANSS scale, mean difference (MD', 'quality of life', ""symptoms' or 'changes in sleep quality"", 'Adverse effects and withdrawals', 'neuropathic pain', 'Self-reported pain relief', 'Neuropathic pain', 'neuropathic pain relief']","[{'cui': 'C0964695', 'cui_str': 's(7)(beta)CD'}, {'cui': 'C0002895', 'cui_str': 'Sickle Cell Disease'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0657912', 'cui_str': 'pregabalin'}, {'cui': 'C0205464', 'cui_str': 'Pharmacologic (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0034380'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0037088', 'cui_str': 'Signs and Symptoms'}, {'cui': 'C0222045'}, {'cui': 'C0027796', 'cui_str': 'Neurodynia'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0451615', 'cui_str': 'Pain relief (procedure)'}, {'cui': 'C1301676', 'cui_str': 'Relieves (qualifier value)'}]",22.0,0.475524,Self-reported pain relief was greater in the pregabalin group compared to the placebo control group but only using the S-LANSS scale and we are very unsure whether there is a difference.,"[{'ForeName': 'Monika R', 'Initials': 'MR', 'LastName': 'Asnani', 'Affiliation': 'Sickle Cell Unit, Caribbean Institute for Health Research, The University of the West Indies, 7 Ring Road, Mona Campus, Kingston 7, Jamaica.'}, {'ForeName': 'Damian K', 'Initials': 'DK', 'LastName': 'Francis', 'Affiliation': ''}, {'ForeName': 'Amanda M', 'Initials': 'AM', 'LastName': 'Brandow', 'Affiliation': ''}, {'ForeName': 'Christine Eo', 'Initials': 'CE', 'LastName': 'Hammond Gabbadon', 'Affiliation': ''}, {'ForeName': 'Amza', 'Initials': 'A', 'LastName': 'Ali', 'Affiliation': ''}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD012943.pub2'] 938,31839957,"A 3-day low-fibre diet does not improve colonoscopy preparation results compared to a 1-day diet: A randomized, single-blind, controlled trial.","Background Although a 1-day low-fibre diet before colonoscopy is currently recommended, some endoscopists prescribe a 3-day diet. Objective The objective of this study was to compare the influence of a 3-day versus a 1-day low-fibre diet on bowel preparation quality, patient tolerability and adherence. Methods Outpatients scheduled for total colonoscopy were randomized in two groups, 3-day versus 1-day low-fibre diet, performing a 4-litre polyethylene glycol split-dose. The primary outcome was a reduction of inappropriate preparations in the 3-day low-fibre diet arm from 15% to 5% (bowel preparation was assessed by the Boston Bowel Preparation Scale). Secondary outcomes were adherence to, difficulty to perform, difficulty to obtain and willingness to repeat the diet. Intention-to-treat (ITT) and per-protocol (PP) analyses were conducted for the primary outcome. Results A total of 412 patients were randomized (206 per group). Bowel preparation quality was similar between groups. On ITT analysis ( n  = 412), adequate bowel preparation was 91.7% (3-day diet) versus 94.7% (1-day diet), p  = 0.24 and on PP analysis ( n  = 400) 93.5% versus 96.5%, respectively, p  = 0.16. Difficulty to perform the diet was significantly higher on the 3-day diet, p  = 0.04. No differences were found on difficulty to obtain the diet, willingness to repeat the diet, adverse events and intra-colonoscopy findings. Conclusion A 3-day low-fibre diet does not bring benefit to the bowel preparation quality and is harder to perform than a 1-day diet.",2019,"No differences were found on difficulty to obtain the diet, willingness to repeat the diet, adverse events and intra-colonoscopy findings. ","['Methods\n\n\nOutpatients scheduled for total colonoscopy', '412 patients']","['1-day low-fibre diet', 'Intention-to-treat (ITT) and per-protocol (PP', '3-day low-fibre diet', '3-day versus 1-day low-fibre diet, performing a 4-litre polyethylene glycol split-dose']","['reduction of inappropriate preparations in the 3-day low-fibre diet arm from 15% to 5% (bowel preparation was assessed by the Boston Bowel Preparation Scale', 'Bowel preparation quality', 'difficulty to obtain the diet, willingness to repeat the diet, adverse events and intra-colonoscopy findings', 'bowel preparation quality, patient tolerability and adherence', 'adherence to, difficulty to perform, difficulty to obtain and willingness to repeat the diet', 'adequate bowel preparation']","[{'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0009556', 'cui_str': 'Total colonoscopy (procedure)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0344356', 'cui_str': 'Restricted fiber diet (finding)'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0475211', 'cui_str': 'L'}, {'cui': 'C0032483', 'cui_str': 'polyethylene oxide'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}]","[{'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C3542467', 'cui_str': 'Inappropriate component (foundation metadata concept)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0344356', 'cui_str': 'Restricted fiber diet (finding)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0455052', 'cui_str': 'Preparation of bowel for procedure (procedure)'}, {'cui': 'C4302285', 'cui_str': 'Boston bowel preparation scale (assessment scale)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C1301820', 'cui_str': 'Obtained (attribute)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C0009378', 'cui_str': 'Endoscopy of colon'}, {'cui': 'C2607943', 'cui_str': 'findings'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0205411', 'cui_str': 'Adequate (qualifier value)'}]",412.0,0.0586382,"No differences were found on difficulty to obtain the diet, willingness to repeat the diet, adverse events and intra-colonoscopy findings. ","[{'ForeName': 'Filipe', 'Initials': 'F', 'LastName': 'Taveira', 'Affiliation': 'Department of Gastroenterology, Portuguese Oncology Institute of Coimbra, Coimbra, Portugal.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Areia', 'Affiliation': 'Department of Gastroenterology, Portuguese Oncology Institute of Coimbra, Coimbra, Portugal.'}, {'ForeName': 'Luís', 'Initials': 'L', 'LastName': 'Elvas', 'Affiliation': 'Department of Gastroenterology, Portuguese Oncology Institute of Coimbra, Coimbra, Portugal.'}, {'ForeName': 'Susana', 'Initials': 'S', 'LastName': 'Alves', 'Affiliation': 'Department of Gastroenterology, Portuguese Oncology Institute of Coimbra, Coimbra, Portugal.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Brito', 'Affiliation': 'Department of Gastroenterology, Portuguese Oncology Institute of Coimbra, Coimbra, Portugal.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Saraiva', 'Affiliation': 'Department of Gastroenterology, Portuguese Oncology Institute of Coimbra, Coimbra, Portugal.'}, {'ForeName': 'Ana T', 'Initials': 'AT', 'LastName': 'Cadime', 'Affiliation': 'Department of Gastroenterology, Portuguese Oncology Institute of Coimbra, Coimbra, Portugal.'}]",United European gastroenterology journal,['10.1177/2050640619883176'] 939,31278067,"Safety and efficacy of epigallocatechin gallate in multiple system atrophy (PROMESA): a randomised, double-blind, placebo-controlled trial.","BACKGROUND Multiple system atrophy is a rare neurodegenerative disease characterised by aggregation of α-synuclein in oligodendrocytes and neurons. The polyphenol epigallocatechin gallate inhibits α-synuclein aggregation and reduces associated toxicity. We aimed to establish if epigallocatechin gallate could safely slow disease progression in patients with multiple system atrophy. METHODS We did a randomised, double-blind, parallel group, placebo-controlled clinical trial at 12 specialist centres in Germany. Eligible participants were older than 30 years; met consensus criteria for possible or probable multiple system atrophy and could ambulate independently (ie, were at Hoehn and Yahr stages 1-3); and were on stable anti-Parkinson's, anti-dysautonomia, anti-dementia, and anti-depressant regimens (if necessary) for at least 1 month. Participants were randomly assigned (1:1) to epigallocatechin gallate or placebo (mannitol) via a web-generated permuted blockwise randomisation list (block size=2) that was stratified by disease subtype (parkinsonism-predominant disease vs cerebellar-ataxia-predominant disease). All participants and study personnel were masked to treatment assignment. Participants were given one hard gelatin capsule (containing either 400 mg epigallocatechin gallate or mannitol) orally once daily for 4 weeks, then one capsule twice daily for 4 weeks, and then one capsule three times daily for 40 weeks. After 48 weeks, all patients underwent a 4-week wash-out period. The primary endpoint was change in motor examination score of the Unified Multiple System Atrophy Rating Scale (UMSARS) from baseline to 52 weeks. Efficacy analyses were done in all people who received at least one dose of study medication. Safety was analysed in all people who received at least one dose of the study medication to which they had been randomly assigned. This trial is registered with ClinicalTrials.gov (NCT02008721) and EudraCT (2012-000928-18), and is completed. FINDINGS Between April 23, 2014, and Sept 3, 2015, 127 participants were screened and 92 were randomly assigned-47 to epigallocatechin gallate and 45 to placebo. Of these, 67 completed treatment and 64 completed the study (altough one of these patients had a major protocol violation). There was no evidence of a difference in the mean change from baseline to week 52 in motor examination scores on UMSARS between the epigallocatechin gallate (5·66 [SE 1·01]) and placebo (6·60 [0·99]) groups (mean difference -0·94 [SE 1·41; 95% CI -3·71 to 1·83]; p=0·51). Four patients in the epigallocatechin gallate group and two in the placebo group died. Two patients in the epigallocatechin gallate group had to stop treatment because of hepatotoxicity. INTERPRETATION 48 weeks of epigallocatechin gallate treatment did not modify disease progression in patients with multiple system atrophy. Epigallocatechin gallate was overall well tolerated but was associated with hepatotoxic effects in some patients, and thus doses of more than 1200 mg should not be used. FUNDING ParkinsonFonds Deutschland, German Parkinson Society, German Neurology Foundation, Lüneburg Foundation, Bischof Dr Karl Golser Foundation, and Dr Arthur Arnstein Foundation.",2019,There was no evidence of a difference in the mean change from baseline to week 52 in motor examination scores on UMSARS between the epigallocatechin gallate (5·66 [SE 1·01]) and placebo (6·60 [0·99]) groups (mean difference -0·94 [SE 1·41; 95% CI -3·71 to 1·83]; p=0·51).,"['12 specialist centres in Germany', 'patients with multiple system atrophy', '67 completed treatment and 64 completed the study (altough one of these patients had a major protocol violation', 'multiple system atrophy (PROMESA', 'Between April 23, 2014, and Sept 3, 2015, 127 participants were screened and 92 were randomly assigned-47 to epigallocatechin gallate and 45 to', ""Eligible participants were older than 30 years; met consensus criteria for possible or probable multiple system atrophy and could ambulate independently (ie, were at Hoehn and Yahr stages 1-3); and were on stable anti-Parkinson's, anti-dysautonomia, anti-dementia, and anti-depressant regimens (if necessary) for at least 1 month"", 'all people who received at least one dose of the study medication to which they had been randomly assigned']","['placebo', 'EudraCT', 'hard gelatin capsule (containing either 400 mg epigallocatechin gallate or mannitol', 'epigallocatechin gallate', 'epigallocatechin gallate treatment', 'epigallocatechin gallate or placebo (mannitol) via a web-generated permuted blockwise randomisation list (block size=2']","['hepatotoxicity', 'toxicity', 'Safety and efficacy', 'hepatotoxic effects', 'change in motor examination score of the Unified Multiple System Atrophy Rating Scale (UMSARS', 'Safety']","[{'cui': 'C0087009', 'cui_str': 'Specialists'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0393571', 'cui_str': 'Multiple System Atrophy Syndrome'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0059438', 'cui_str': 'epigallocatechin gallate'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0376298', 'cui_str': 'Consensus'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332149', 'cui_str': 'Possible (qualifier value)'}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis (contextual qualifier) (qualifier value)'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1 (qualifier value)'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0013363', 'cui_str': 'Dysautonomia'}, {'cui': 'C0497327', 'cui_str': 'Amentia'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0018599', 'cui_str': 'Hardness'}, {'cui': 'C0017237', 'cui_str': 'Gelatin'}, {'cui': 'C4319574', 'cui_str': 'Capsule'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C0059438', 'cui_str': 'epigallocatechin gallate'}, {'cui': 'C0887166', 'cui_str': '(L)-Mannitol'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}]","[{'cui': 'C0235378', 'cui_str': 'Hepatotoxicity'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C1273867', 'cui_str': 'Examination (heading)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0393571', 'cui_str': 'Multiple System Atrophy Syndrome'}, {'cui': 'C0222045'}]",127.0,0.6823,There was no evidence of a difference in the mean change from baseline to week 52 in motor examination scores on UMSARS between the epigallocatechin gallate (5·66 [SE 1·01]) and placebo (6·60 [0·99]) groups (mean difference -0·94 [SE 1·41; 95% CI -3·71 to 1·83]; p=0·51).,"[{'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Levin', 'Affiliation': 'Department of Neurology, Ludwig-Maximilians-University Munich, Munich, Germany; German Center for Neurodegenerative Diseases, Munich, Germany; Munich Cluster for Systems Neurology, Munich, Germany.'}, {'ForeName': 'Sylvia', 'Initials': 'S', 'LastName': 'Maaß', 'Affiliation': 'German Center for Neurodegenerative Diseases, Munich, Germany; Munich Cluster for Systems Neurology, Munich, Germany; Department of Neurology, Technical University Munich, Munich, Germany.'}, {'ForeName': 'Madeleine', 'Initials': 'M', 'LastName': 'Schuberth', 'Affiliation': 'Department of Neurology, Ludwig-Maximilians-University Munich, Munich, Germany.'}, {'ForeName': 'Armin', 'Initials': 'A', 'LastName': 'Giese', 'Affiliation': 'Center for Neuropathology and Prion Research, Ludwig-Maximilians-University Munich, Munich, Germany.'}, {'ForeName': 'Wolfgang H', 'Initials': 'WH', 'LastName': 'Oertel', 'Affiliation': 'Department of Neurology, Philipps-Universität Marburg, Marburg, Germany.'}, {'ForeName': 'Werner', 'Initials': 'W', 'LastName': 'Poewe', 'Affiliation': 'Department of Neurobiology, Medizinische Universität Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Trenkwalder', 'Affiliation': 'Paracelsus-Elena-Klinik, Kassel, Germany; Department of Neurosurgery, University Medical Center Göttingen, Göttingen, Germany.'}, {'ForeName': 'Gregor K', 'Initials': 'GK', 'LastName': 'Wenning', 'Affiliation': 'Department of Neurobiology, Medizinische Universität Innsbruck, Innsbruck, Austria.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Mansmann', 'Affiliation': 'Institute for Medical Informatics, Biometry and Epidemiology, Ludwig-Maximilians-University Munich, Munich, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Südmeyer', 'Affiliation': 'Institute of Clinical Neuroscience and Medical Psychology, Heinrich-Heine-University, Düsseldorf, Germany.'}, {'ForeName': 'Karla', 'Initials': 'K', 'LastName': 'Eggert', 'Affiliation': 'Department of Neurology, Philipps-Universität Marburg, Marburg, Germany.'}, {'ForeName': 'Brit', 'Initials': 'B', 'LastName': 'Mollenhauer', 'Affiliation': 'Paracelsus-Elena-Klinik, Kassel, Germany; Department of Neurology, University Medical Center Göttingen, Göttingen, Germany.'}, {'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Lipp', 'Affiliation': 'Department of Neurology, Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Löhle', 'Affiliation': 'Department of Neurology, University of Rostock, Rostock, Germany; German Center for Neurodegenerative Diseases, Rostock, Germany; Department of Neurology, Technische Universität Dresden, Dresden, Germany.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Classen', 'Affiliation': 'Department of Neurology, University of Leipzig, Leipzig Germany.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Münchau', 'Affiliation': 'Institute of Neurogenetics, University of Leipzig, Leipzig Germany.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Kassubek', 'Affiliation': 'Department of Neurology, University of Ulm, Ulm, Germany.'}, {'ForeName': 'Florin', 'Initials': 'F', 'LastName': 'Gandor', 'Affiliation': 'Movement Disorders Hospital, Beelitz-Heilstätten, Germany.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Berg', 'Affiliation': 'Department of Neurodegeneration, Hertie-Institute for Clinical Brain Research, University of Tübingen, Tübingen, Germany; Department of Neurology, Christian-Albrechts-University Kiel, Kiel, Germany.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Egert-Schwender', 'Affiliation': 'Münchner Studienzentrum, Technical University Munich, Munich, Germany.'}, {'ForeName': 'Cornelia', 'Initials': 'C', 'LastName': 'Eberhardt', 'Affiliation': 'Pharmacy Department, Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany.'}, {'ForeName': 'Friedemann', 'Initials': 'F', 'LastName': 'Paul', 'Affiliation': 'Charité-Universitätsmedizin Berlin, Freie Universität Berlin and Humboldt-Universität zu Berlin, Berlin, Germany; Max Delbrueck Center for Molecular Medicine, NeuroCure Experimental and Clinical Research Center, Berlin, Germany.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Bötzel', 'Affiliation': 'Department of Neurology, Ludwig-Maximilians-University Munich, Munich, Germany.'}, {'ForeName': 'Birgit', 'Initials': 'B', 'LastName': 'Ertl-Wagner', 'Affiliation': 'Department of Radiology, Ludwig-Maximilians-University Munich, Munich, Germany; Department of Radiology, The Hopsital for Sick Children, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Hans-Jürgen', 'Initials': 'HJ', 'LastName': 'Huppertz', 'Affiliation': 'Swiss Epilepsy Clinic, Klinik Lengg, Zurich, Switzerland.'}, {'ForeName': 'Ingrid', 'Initials': 'I', 'LastName': 'Ricard', 'Affiliation': 'Institute for Medical Informatics, Biometry and Epidemiology, Ludwig-Maximilians-University Munich, Munich, Germany.'}, {'ForeName': 'Günter U', 'Initials': 'GU', 'LastName': 'Höglinger', 'Affiliation': 'German Center for Neurodegenerative Diseases, Munich, Germany; Department of Neurology, Technical University Munich, Munich, Germany; Department of Neurology, Hanover Medical School, Hanover, Germany. Electronic address: guenter.hoeglinger@dzne.de.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Neurology,['10.1016/S1474-4422(19)30141-3'] 940,31272926,Anticipatory postural adjustments are modulated by substantia nigra stimulation in people with Parkinson's disease and freezing of gait.,"BACKGROUND A precise understanding of the neuronal circuits involved in the control of anticipatory postural adjustments (APAs) for gait initiation is missing. Neurostimulation in Parkinson's disease (PD) provides a method of modulating APAs to gain insight into the underlying circuitry. OBJECTIVE Our objective was to investigate if APA kinematics for step initiation could be modulated by high frequency stimulation of the subthalamic nucleus (STN) or substantia nigra pars reticulata (SNr) in people with PD and freezing of gait (FoG). METHODS We studied 14 people with PD and FoG using neurostimulation of the STN and SNr areas after overnight withdrawal of dopaminergic medication on the instrumented stand and walk test. We tested patients in the following randomized conditions: 'off stimulation', 'STN' stimulation (only), and 'SNr' stimulation (only). Patients were blinded to the stimulation condition. The APAs were recorded with inertial sensors and processed offline. Moreover, we assessed clinical scores with respect to motor symptoms, non-motor symptoms, executive function, and FoG. RESULTS SNr but not STN stimulation modulated the anterio-posterior size of APA. The SNr modulation of APA was associated with the stimulation effect on FoG (trend; r = 0.580, P = 0.102). The APA modulation was not correlated with any other cognitive or clinical measures. CONCLUSION Neuromodulation of the SNr but not of the STN modulated APAs in PD patients with FoG. The different effects of STN or SNr on the kinematic parameters of APA support the concept of segregate targets in order to address diverse kinematic components of PD gait.",2019,"The SNr modulation of APA was associated with the stimulation effect on FoG (trend; r = 0.580, P = 0.102).","[""Parkinson's disease (PD"", 'people with PD and freezing of gait (FoG', '14 people with PD and FoG using neurostimulation of the STN and SNr areas after overnight withdrawal of dopaminergic medication on the instrumented stand and walk test', ""people with Parkinson's disease and freezing of gait"", 'PD patients with FoG']","['STN or SNr', ""stimulation', 'STN' stimulation (only), and 'SNr' stimulation (only""]",[],"[{'cui': 'C0030567', 'cui_str': 'Idiopathic Parkinson Disease'}, {'cui': 'C0860515', 'cui_str': 'Freezing of gait'}, {'cui': 'C0450030', 'cui_str': 'Fog'}, {'cui': 'C0521307', 'cui_str': 'Neurostimulation'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0439583', 'cui_str': 'Overnight (qualifier value)'}, {'cui': 'C4551823', 'cui_str': 'instruments'}, {'cui': 'C3888057', 'cui_str': 'Stand'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}]",[],14.0,0.113065,"The SNr modulation of APA was associated with the stimulation effect on FoG (trend; r = 0.580, P = 0.102).","[{'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Heilbronn', 'Affiliation': 'Department of Neurodegenerative Diseases and Hertie Institute for Clinical Brain Research (HIH), University of Tuebingen, Germany; German Centre of Neurodegenerative Diseases (DZNE), University of Tuebingen, Tuebingen, Germany.'}, {'ForeName': 'Marlieke', 'Initials': 'M', 'LastName': 'Scholten', 'Affiliation': 'Department of Neurodegenerative Diseases and Hertie Institute for Clinical Brain Research (HIH), University of Tuebingen, Germany; German Centre of Neurodegenerative Diseases (DZNE), University of Tuebingen, Tuebingen, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Schlenstedt', 'Affiliation': 'Department of Neurology, University Hospital Schleswig-Holstein, Christian-Albrechts-University, Kiel, Germany.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Mancini', 'Affiliation': 'Balance Disorders Laboratory, Oregon Health & Science University, Portland, OR, United States.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Schöllmann', 'Affiliation': 'Department of Neurodegenerative Diseases and Hertie Institute for Clinical Brain Research (HIH), University of Tuebingen, Germany; German Centre of Neurodegenerative Diseases (DZNE), University of Tuebingen, Tuebingen, Germany.'}, {'ForeName': 'Idil', 'Initials': 'I', 'LastName': 'Cebi', 'Affiliation': 'Department of Neurodegenerative Diseases and Hertie Institute for Clinical Brain Research (HIH), University of Tuebingen, Germany; German Centre of Neurodegenerative Diseases (DZNE), University of Tuebingen, Tuebingen, Germany.'}, {'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Pötter-Nerger', 'Affiliation': 'Department of Neurology, University Medical Centre Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Gharabaghi', 'Affiliation': 'Division of Functional and Restorative Neurosurgery, Department of Neurosurgery, and Werner Reichardt Centre for Integrative Neuroscience, University of Tuebingen, Tuebingen, Germany.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Weiss', 'Affiliation': 'Department of Neurodegenerative Diseases and Hertie Institute for Clinical Brain Research (HIH), University of Tuebingen, Germany; German Centre of Neurodegenerative Diseases (DZNE), University of Tuebingen, Tuebingen, Germany. Electronic address: daniel.weiss@uni-tuebingen.de.'}]",Parkinsonism & related disorders,['10.1016/j.parkreldis.2019.06.023'] 941,31840260,The effect of web-based pediatric palliative care education on the palliative care knowledge level and practices of nursing students.,"PURPOSE This study is aimed to investigate the effect of web-based pediatric palliative care education on nursing students' knowledge level and practices related to palliative care. METHODS The study was conducted with 265 nursing students including an intervention and a control group. The intervention group was given web-based pediatric palliative care education. FINDINGS A statistically significant difference was found between the total and subscale pretest and posttest scores of the students in the intervention and control groups regarding the palliative care knowledge level and self-reported palliative care practices. PRACTICAL IMPLICATIONS The web-based pediatric palliative care education is an effective training model for nursing students to improve palliative care knowledge level and practices of the students.",2020,"FINDINGS A statistically significant difference was found between the total and subscale pretest and posttest scores of the students in the intervention and control groups regarding the palliative care knowledge level and self-reported palliative care practices. ","['265 nursing students including an intervention and a control group', 'nursing students']","['web-based pediatric palliative care education', 'intervention group was given web-based pediatric palliative care education']",[],"[{'cui': 'C0038496', 'cui_str': 'Pupil Nurses'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C3266593', 'cui_str': 'Palliative care education'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1947971', 'cui_str': 'Give'}]",[],,0.0278992,"FINDINGS A statistically significant difference was found between the total and subscale pretest and posttest scores of the students in the intervention and control groups regarding the palliative care knowledge level and self-reported palliative care practices. ","[{'ForeName': 'Aslı', 'Initials': 'A', 'LastName': 'Akdeniz Kudubes', 'Affiliation': 'Department of Pediatric Nursing, Faculty of Nursing, Dokuz Eylul University, Izmir, Turkey.'}, {'ForeName': 'Murat', 'Initials': 'M', 'LastName': 'Bektas', 'Affiliation': 'Department of Pediatric Nursing, Faculty of Nursing, Dokuz Eylul University, Izmir, Turkey.'}]",Perspectives in psychiatric care,['10.1111/ppc.12463'] 942,31274114,Motivational Interviewing to Reduce Drug Use and HIV Incidence Among Young Men Who Have Sex With Men in Relationships and Are High Priority for Pre-Exposure Prophylaxis (Project PARTNER): Randomized Controlled Trial Protocol.,"BACKGROUND Men who have sex with men (MSM) currently account for more than two-thirds of new HIV diagnoses in the United States and, among young MSM (YMSM) aged 20 to 29 years, as many as 79% to 84% of new infections occur between primary partners. Contributing to HIV risk, YMSM use drugs at comparatively high rates. To date, no interventions have been developed that specifically address the unique needs of partnered YMSM or incorporate a focus on relationship factors in addressing personal motivation for change. OBJECTIVE The study's primary aim is to evaluate the efficacy of the PARTNER intervention and evaluate potential moderators or mediators of intervention effects. The study's secondary aims were to gather ideographic data to inform a future effectiveness implementation study and develop a novel biomarker for pre-exposure prophylaxis (PrEP) adherence by analyzing PrEP drug levels in fingernails. METHODS PARTNER is a 4-session motivational interviewing-based intervention that integrates video-based communication training to address drug use and HIV prevention among partnered YMSM. This study utilizes a randomized controlled trial design to compare the PARTNER intervention with an attention-matched psychoeducation control arm that provides information about HIV-risk reduction, PrEP, and substance use. Participants are randomized in a 1-to-1 ratio stratified on age disparity between partners, racial composition of the couple, and relationship length. Follow-up assessments are conducted at 3-, 6-, 9-, and 12-months postbaseline. The study recruits and enrolls 240 partnered YMSM aged between 18 to 29 years at a research center in New York City. Participants will be HIV-negative and report recent (past 30-day) drug use and condomless anal sex with casual partners; a nonmonogamous primary partner (regardless of HIV status); or a serodiscordant primary partner (regardless of sexual agreement). Primary outcomes (drug use and HIV sexual transmission risk behavior) are assessed via a Timeline Follow-back interview. Biological markers of outcomes are collected for drug use (fingernail assay), sexual HIV transmission risk (rectal and urethral gonorrhea and chlamydia testing), and PrEP adherence (dried blood spots and fingernails for a novel PrEP drug level assay). RESULTS The study opened for enrollment in February 2018. Anticipated completion of enrollment is October 2021. Primary outcome analyses will begin after final follow-up completion. CONCLUSIONS Existing research on partnered YMSM within the framework of Couples Interdependence Theory (CIT) has suggested that relationship factors (eg, dyadic functioning and sexual agreements) are meaningfully related to drug use and HIV transmission risk. Results pertaining to the efficacy of the proposed intervention and the identification of putative moderators and mediators will substantially inform the tailoring of interventions for YMSM in relationships and contribute to a growing body of relationship science focused on enhancing health outcomes. TRIAL REGISTRATION ClinicalTrials.gov NCT03396367; https://clinicaltrials.gov/ct2/show/NCT03396367 (Archived by WebCite at http://www.webcitation.org/78ti7esTc. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID) DERR1-10.2196/13015.",2019,"METHODS PARTNER is a 4-session motivational interviewing-based intervention that integrates video-based communication training to address drug use and HIV prevention among partnered YMSM.","['Men who have sex with men (MSM) currently account for more than two-thirds of new HIV diagnoses in the United States and, among young MSM (YMSM) aged 20 to 29 years, as many as 79% to 84% of new infections occur between primary partners', 'Young Men', 'The study recruits and enrolls 240 partnered YMSM aged between 18 to 29 years at a research center in New York City', 'partnered YMSM', 'Participants will be HIV-negative and report recent (past 30-day) drug use and condomless anal sex with casual partners; a nonmonogamous primary partner (regardless of HIV status); or a serodiscordant primary partner (regardless of sexual agreement']","['attention-matched psychoeducation control', 'Motivational Interviewing', '4-session motivational interviewing-based intervention that integrates video-based communication training']","['Primary outcomes (drug use and HIV sexual transmission risk behavior) are assessed via a Timeline Follow-back interview', 'Drug Use and HIV Incidence', 'begin after final follow-up completion']","[{'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0205437', 'cui_str': 'Third (qualifier value)'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439633', 'cui_str': 'New infection (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0682323', 'cui_str': 'Companion'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C4319600', 'cui_str': '240 (qualifier value)'}, {'cui': 'C0035168'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0027977', 'cui_str': 'New York City'}, {'cui': 'C0481430', 'cui_str': 'HTLV-3 antibody negative'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C1444637', 'cui_str': 'In the past'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0449889', 'cui_str': 'Drug used (attribute)'}, {'cui': 'C0282347', 'cui_str': 'Anal Sex'}, {'cui': 'C0458074', 'cui_str': 'HIV status'}]","[{'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0871175', 'cui_str': 'Psycho-education'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0683474', 'cui_str': 'Motivational Interviewing'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0449889', 'cui_str': 'Drug used (attribute)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C1519279', 'cui_str': 'Sexual transmission'}, {'cui': 'C0086931', 'cui_str': 'Risk Behavior'}, {'cui': 'C0145943', 'cui_str': 'TimeLine'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]",,0.10462,"METHODS PARTNER is a 4-session motivational interviewing-based intervention that integrates video-based communication training to address drug use and HIV prevention among partnered YMSM.","[{'ForeName': 'Tyrel J', 'Initials': 'TJ', 'LastName': 'Starks', 'Affiliation': 'Hunter College, City University of New York, New York, NY, United States.'}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Robles', 'Affiliation': 'Hunter College, City University of New York, New York, NY, United States.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Pawson', 'Affiliation': 'Doctoral Program in Sociology, Graduate Center, City University of New York, New York, NY, United States.'}, {'ForeName': 'Ruben H', 'Initials': 'RH', 'LastName': 'Jimenez', 'Affiliation': 'Hunter College, City University of New York, New York, NY, United States.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Gandhi', 'Affiliation': 'Division of HIV, Infectious Diseases, and Global Medicine, Department of Medicine, University of California San Francisco, San Francisco, CA, United States.'}, {'ForeName': 'Jeffrey T', 'Initials': 'JT', 'LastName': 'Parsons', 'Affiliation': 'Hunter College, City University of New York, New York, NY, United States.'}, {'ForeName': 'Brett M', 'Initials': 'BM', 'LastName': 'Millar', 'Affiliation': 'Hunter College, City University of New York, New York, NY, United States.'}]",JMIR research protocols,['10.2196/13015'] 943,32409944,"Evidence for improved survival with bevacizumab treatment in recurrent high-grade gliomas: a retrospective study with (""pseudo-randomized"") treatment allocation by the health insurance provider.","INTRODUCTION Despite a large number of trials, the role of bevacizumab (BEV) in the treatment of recurrent high-grade gliomas is still controversial. Evidence regarding an effect on overall survival in this context is ultimately inconclusive. At the Department of Radiation Oncology at Erlangen, Germany we treated a large cohort of patients with recurrent gliomas where bevacizumab use was determined exclusively by the health care provider's approval of reimbursement. METHODS 61 patients (between 06/2008 and 01/2014) with recurrent high-grade gliomas had reimbursement requests for BEV sent to their health insurance. 37 patients out of 61 (60.7%) had their requests approved and therefore received bevacizumab (BEV-arm) as part of their treatment. The remaining 24 (39.3%) patients received standard therapy without bevacizumab (non-BEV-arm). Survival endpoints were defined with reference to the first BEV request to the health insurance provider. RESULTS Median overall survival (OS) for the whole cohort was 7.0 months. OS was significantly better for BEV vs. Non-BEV patients (median, 10.3 vs. 4.2 months, logrank p = 0.023). There was an increased BEV benefit in cases of higher-order recurrences (first order recurrence BEV vs. Non-BEV, 12.5 vs. 10.2 months, p = 0.578) (second or higher order of recurrence, 9.9 vs. 2.6 months, p = 0.010). On multivariate analysis for overall survival the prognostic impact of bevacizumab (HR = 0.43, p = 0.034) remained significant. CONCLUSION Our results suggest an influence of BEV on overall survival in a heavily pretreated patient population suffering from high-grade gliomas with BEV benefit being greatest in case of second or later recurrence.",2020,"On multivariate analysis for overall survival the prognostic impact of bevacizumab (HR = 0.43, p = 0.034) remained significant. ","['recurrent high-grade gliomas', '61 patients (between 06/2008 and 01/2014) with recurrent high-grade gliomas had reimbursement requests for BEV sent to their health insurance', '37 patients out of 61 (60.7%) had their requests approved and therefore received']","['standard therapy without bevacizumab', 'bevacizumab (BEV', 'bevacizumab']","['OS', 'overall survival', 'survival', 'Median overall survival (OS', 'BEV benefit', 'Survival endpoints']","[{'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0555198', 'cui_str': 'Glioma, malignant, no ICD-O subtype'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0686900', 'cui_str': 'Request for'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0021682', 'cui_str': 'Health Insurance'}, {'cui': 'C0205540', 'cui_str': 'Approved'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}]","[{'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}]",61.0,0.0806815,"On multivariate analysis for overall survival the prognostic impact of bevacizumab (HR = 0.43, p = 0.034) remained significant. ","[{'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Hofmann', 'Affiliation': 'Department of Radiotherapy, Friedrich-Alexander-Universität Erlangen-Nürnberg, Universitaetsstraße 27, 91054, Erlangen, Germany.'}, {'ForeName': 'Manuel Alexander', 'Initials': 'MA', 'LastName': 'Schmidt', 'Affiliation': 'Department of Neuroradiology, Friedrich-Alexander-Universität Erlangen-Nürnberg, Schwabachanlage 6, 91054, Erlangen, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Weissmann', 'Affiliation': 'Department of Radiotherapy, Friedrich-Alexander-Universität Erlangen-Nürnberg, Universitaetsstraße 27, 91054, Erlangen, Germany.'}, {'ForeName': 'Ilker', 'Initials': 'I', 'LastName': 'Eyüpoglu', 'Affiliation': 'Department of Neurosurgery, Friedrich-Alexander-Universität Erlangen-Nürnberg, Schwabachanlage 6, 91054, Erlangen, Germany.'}, {'ForeName': 'Annedore', 'Initials': 'A', 'LastName': 'Strnad', 'Affiliation': 'Department of Radiotherapy, Friedrich-Alexander-Universität Erlangen-Nürnberg, Universitaetsstraße 27, 91054, Erlangen, Germany.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Semrau', 'Affiliation': 'Department of Radiotherapy, Friedrich-Alexander-Universität Erlangen-Nürnberg, Universitaetsstraße 27, 91054, Erlangen, Germany.'}, {'ForeName': 'Rainer', 'Initials': 'R', 'LastName': 'Fietkau', 'Affiliation': 'Department of Radiotherapy, Friedrich-Alexander-Universität Erlangen-Nürnberg, Universitaetsstraße 27, 91054, Erlangen, Germany.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Putz', 'Affiliation': 'Department of Radiotherapy, Friedrich-Alexander-Universität Erlangen-Nürnberg, Universitaetsstraße 27, 91054, Erlangen, Germany. florian.putz@uk-erlangen.de.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Lettmaier', 'Affiliation': 'Department of Radiotherapy, Friedrich-Alexander-Universität Erlangen-Nürnberg, Universitaetsstraße 27, 91054, Erlangen, Germany.'}]",Journal of neuro-oncology,['10.1007/s11060-020-03533-5'] 944,31270676,Augmented reality and artificial intelligence-based navigation during percutaneous vertebroplasty: a pilot randomised clinical trial.,"PURPOSE To assess technical feasibility, accuracy, safety and patient radiation exposure of a novel navigational tool integrating augmented reality (AR) and artificial intelligence (AI), during percutaneous vertebroplasty of patients with vertebral compression fractures (VCFs). MATERIAL AND METHODS This prospective parallel randomised open trial compared the trans-pedicular access phase of percutaneous vertebroplasty across two groups of 10 patients, electronically randomised, with symptomatic single-level VCFs. Trocar insertion was performed using AR/AI-guidance with motion compensation in Group A, and standard fluoroscopy in Group B. The primary endpoint was technical feasibility in Group A. Secondary outcomes included the comparison of Groups A and B in terms of accuracy of trocar placement (distance between planned/actual trajectory on sagittal/coronal fluoroscopic images); complications; time for trocar deployment; and radiation dose/fluoroscopy time. RESULTS Technical feasibility in Group A was 100%. Accuracy in Group A was 1.68 ± 0.25 mm (skin entry point), and 1.02 ± 0.26 mm (trocar tip) in the sagittal plane, and 1.88 ± 0.28 mm (skin entry point) and 0.86 ± 0.17 mm (trocar tip) in the coronal plane, without any significant difference compared to Group B (p > 0.05). No complications were observed in the entire population. Time for trocar deployment was significantly longer in Group A (642 ± 210 s) than in Group B (336 ± 60 s; p = 0.001). Dose-area product and fluoroscopy time were significantly lower in Group A (182.6 ± 106.7 mGy cm 2 and 5.2 ± 2.6 s) than in Group B (367.8 ± 184.7 mGy cm 2 and 10.4 ± 4.1 s; p = 0.025 and 0.005), respectively. CONCLUSION AR/AI-guided percutaneous vertebroplasty appears feasible, accurate and safe, and facilitates lower patient radiation exposure compared to standard fluoroscopic guidance. These slides can be retrieved under Electronic Supplementary Material.",2020,Dose-area product and fluoroscopy time were significantly lower in Group A (182.6 ± 106.7 mGy cm 2 and 5.2 ± 2.6 s) than in Group B (367.8 ± 184.7 ,"['patients with vertebral compression fractures (VCFs', 'across two groups of 10 patients, electronically randomised, with symptomatic single-level VCFs']","['trans-pedicular access phase of percutaneous vertebroplasty', 'Augmented reality and artificial intelligence-based navigation during percutaneous vertebroplasty', 'novel navigational tool integrating augmented reality (AR) and artificial intelligence (AI']","['technical feasibility', 'Dose-area product and fluoroscopy time', 'comparison of Groups A and B in terms of accuracy of trocar placement (distance between planned/actual trajectory on sagittal/coronal fluoroscopic images); complications; time for trocar deployment; and radiation dose/fluoroscopy time', 'Time for trocar deployment', 'technical feasibility, accuracy, safety and patient radiation exposure']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0521169', 'cui_str': 'Compression fracture (morphologic abnormality)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]","[{'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach - access (qualifier value)'}, {'cui': 'C1303192', 'cui_str': 'Vertebroplasty'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0003916', 'cui_str': 'AI (Artificial Intelligence)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0336791', 'cui_str': 'Tool, device (physical object)'}]","[{'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0016356', 'cui_str': 'Fluoroscopy'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0441835', 'cui_str': 'Group A (qualifier value)'}, {'cui': 'C0041158', 'cui_str': 'Trocar'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C0205129', 'cui_str': 'Sagittal (qualifier value)'}, {'cui': 'C0205123', 'cui_str': 'Coronal (qualifier value)'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0015333', 'cui_str': 'Exposure to radiation (event)'}]",,0.0644812,Dose-area product and fluoroscopy time were significantly lower in Group A (182.6 ± 106.7 mGy cm 2 and 5.2 ± 2.6 s) than in Group B (367.8 ± 184.7 ,"[{'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Auloge', 'Affiliation': ""Interventional Radiology, Imagerie Interventionnelle, Nouvel Hôpital Civil, University Hospital of Strasbourg, 1, Place de l'Hôpital, B.P. 426, 67091, Strasbourg Cedex, France. pierreauloge@gmail.com.""}, {'ForeName': 'Roberto Luigi', 'Initials': 'RL', 'LastName': 'Cazzato', 'Affiliation': ""Interventional Radiology, Imagerie Interventionnelle, Nouvel Hôpital Civil, University Hospital of Strasbourg, 1, Place de l'Hôpital, B.P. 426, 67091, Strasbourg Cedex, France.""}, {'ForeName': 'Nitin', 'Initials': 'N', 'LastName': 'Ramamurthy', 'Affiliation': 'Department of Radiology, Norfolk and Norwich University Hospital, Colney Lane, Norwich, NR4 7UY, UK.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'de Marini', 'Affiliation': ""Interventional Radiology, Imagerie Interventionnelle, Nouvel Hôpital Civil, University Hospital of Strasbourg, 1, Place de l'Hôpital, B.P. 426, 67091, Strasbourg Cedex, France.""}, {'ForeName': 'Chloé', 'Initials': 'C', 'LastName': 'Rousseau', 'Affiliation': 'Clinical Investigation Center INSERM 1414, University Hospital of Rennes and University of Rennes, Rennes, France.'}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Garnon', 'Affiliation': ""Interventional Radiology, Imagerie Interventionnelle, Nouvel Hôpital Civil, University Hospital of Strasbourg, 1, Place de l'Hôpital, B.P. 426, 67091, Strasbourg Cedex, France.""}, {'ForeName': 'Yan Philippe', 'Initials': 'YP', 'LastName': 'Charles', 'Affiliation': ""Service de Chirurgie du Rachis, Hôpitaux Universitaires de Strasbourg, Fédération de Médecine Translationnelle (FMTS), Université de Strasbourg, 1, Place de l'Hôpital, B.P. 426, 67091, Strasbourg Cedex, France.""}, {'ForeName': 'Jean-Paul', 'Initials': 'JP', 'LastName': 'Steib', 'Affiliation': ""Service de Chirurgie du Rachis, Hôpitaux Universitaires de Strasbourg, Fédération de Médecine Translationnelle (FMTS), Université de Strasbourg, 1, Place de l'Hôpital, B.P. 426, 67091, Strasbourg Cedex, France.""}, {'ForeName': 'Afshin', 'Initials': 'A', 'LastName': 'Gangi', 'Affiliation': ""Interventional Radiology, Imagerie Interventionnelle, Nouvel Hôpital Civil, University Hospital of Strasbourg, 1, Place de l'Hôpital, B.P. 426, 67091, Strasbourg Cedex, France.""}]","European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society",['10.1007/s00586-019-06054-6'] 945,30973547,Sustained Effect of a Community-based Behavioral and Nutrition Intervention on HIV-related Outcomes Among Women Living With HIV in Rural India: A Quasi-experimental Trial.,"BACKGROUND Women living with HIV (WLH) in rural communities face challenges to obtaining treatment and accurate disease-related information. Nutritional deficits exacerbate disease progression. SETTING WLH were recruited from primary health centers in rural India. METHOD A quasi-experimental trial of a comprehensive Accredited Social Health Activist (Asha)-supported intervention compared 4 distinct Asha-based programs [(1) standard education (SE) alone; (2) nutrition education (+NE); (3) nutrition supplements (+NS); or (4) nutrition education and nutrition supplements (+NENS)] on key disease and nutrition-related outcomes [CD4 count, body mass index (BMI), serum albumin, and hemoglobin]. Assessments occurred at baseline, and months 6 (immediately after intervention), 12, and 18. Multilevel modeling examined effects of program (group) over time. FINDINGS Among 600 WLH enrolled (n = 150 per arm), mean age, CD4 count, and BMI (kg/m) were 34.31, 447.42, and 20.09, respectively, at baseline. At 18-month follow-up, program 4 (+NENS) experienced greatest improvements in CD4 counts compared with program 1 (+SE) [adjusted difference = 223.81, 95% confidence interval (CI): 170.29 to 277.32]. For BMI, programs 3 (+NS; adjusted difference = 2.33, 95% CI: 1.39 to 3.26) and 4 (+NENS; adjusted difference = 2.14, 95% CI: 1.17 to 3.12) exhibited greater gains compared with program 1 (+SE). Programs 3 and 4 were not significantly different from each other (adjusted difference = -0.18, 95% CI: -1.12 to 0.76). Hemoglobin and serum albumin also improved over time; program 4 (+NENS) exhibited the greatest gains. CONCLUSIONS A low-cost Asha-supported behavioral and nutritional intervention improved outcomes for WLH. Gains were sustained at 18-month follow-up. Similar approaches may help improve HIV and other infectious disease-related outcomes in vulnerable populations.",2019,"For BMI, programs 3 (+NS; adjusted difference = 2.33, 95% CI: 1.39 to 3.26) and 4 (+NENS; adjusted difference = 2.14, 95% CI: 1.17 to 3.12) exhibited greater gains compared with program 1 (+SE).","['600 WLH enrolled (n = 150 per arm), mean age, CD4 count, and BMI (kg/m', 'WLH were recruited from primary health centers in rural India', 'Women Living With HIV in Rural India', 'Women living with HIV (WLH']","['comprehensive Accredited Social Health Activist (Asha)-supported intervention compared 4 distinct Asha-based programs [(1) standard education (SE) alone; (2) nutrition education (+NE); (3) nutrition supplements (+NS); or (4) nutrition education and nutrition supplements (+NENS', 'Community-based Behavioral and Nutrition Intervention']","['Hemoglobin and serum albumin', 'key disease and nutrition-related outcomes [CD4 count, body mass index (BMI), serum albumin, and hemoglobin', 'CD4 counts']","[{'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0243009', 'cui_str': 'CD4+ Counts'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0475309', 'cui_str': 'Health center (environment)'}, {'cui': 'C0021201', 'cui_str': 'Republic of India'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0204934', 'cui_str': 'Nutritional education'}, {'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}, {'cui': 'C0009462', 'cui_str': 'Community'}]","[{'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0523465', 'cui_str': 'Albumin measurement, serum (procedure)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0243009', 'cui_str': 'CD4+ Counts'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]",600.0,0.0974018,"For BMI, programs 3 (+NS; adjusted difference = 2.33, 95% CI: 1.39 to 3.26) and 4 (+NENS; adjusted difference = 2.14, 95% CI: 1.17 to 3.12) exhibited greater gains compared with program 1 (+SE).","[{'ForeName': 'Adeline M', 'Initials': 'AM', 'LastName': 'Nyamathi', 'Affiliation': 'Sue & Bill Gross School of Nursing, University of California, Irvine, CA.'}, {'ForeName': 'Sanghyuk S', 'Initials': 'SS', 'LastName': 'Shin', 'Affiliation': 'Sue & Bill Gross School of Nursing, University of California, Irvine, CA.'}, {'ForeName': 'Sanjeev', 'Initials': 'S', 'LastName': 'Sinha', 'Affiliation': 'School of Medicine, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Catherine L', 'Initials': 'CL', 'LastName': 'Carpenter', 'Affiliation': 'Center for Human Nutrition, David Geffen School of Medicine, University of California, Los Angeles, CA.'}, {'ForeName': 'Dana Rose', 'Initials': 'DR', 'LastName': 'Garfin', 'Affiliation': 'Sue & Bill Gross School of Nursing, University of California, Irvine, CA.'}, {'ForeName': 'Padma', 'Initials': 'P', 'LastName': 'Ramakrishnan', 'Affiliation': 'School of Medicine, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Kartik', 'Initials': 'K', 'LastName': 'Yadav', 'Affiliation': 'Sue & Bill Gross School of Nursing, University of California, Irvine, CA.'}, {'ForeName': 'Maria L', 'Initials': 'ML', 'LastName': 'Ekstrand', 'Affiliation': 'School of Medicine, University of California, San Francisco, CA.'}]",Journal of acquired immune deficiency syndromes (1999),['10.1097/QAI.0000000000002044'] 946,30452776,Moderate Renal Impairment Does Not Impact the Ability of CSL112 (Apolipoprotein A-I [Human]) to Enhance Cholesterol Efflux Capacity.,"CSL112 (apolipoprotein A-I [human]) is a novel intravenous formulation of plasma-derived apolipoprotein A-I (apoA-I) that enhances cholesterol efflux capacity. Renal impairment is a common comorbidity in acute myocardial infarction patients and is associated with impaired lipid metabolism. The aim of this phase 1 study was to assess the impact of moderate renal impairment on the pharmacokinetic and pharmacodynamic profile of CSL112. Sixteen subjects with moderate renal impairment and 16 age-, sex-, and weight-matched subjects with normal renal function participated in the study. Within each renal function cohort, subjects were randomized 3:1 to receive a single intravenous infusion of CSL112 2 g (n = 6) or placebo (n = 2) or CSL112 6 g (n = 6) or placebo (n = 2). At baseline, subjects with moderate renal impairment versus normal renal function had higher total cholesterol efflux, ABCA1-dependent cholesterol efflux capacity, and pre-β1-high-density lipoprotein (HDL) levels. Infusing CSL112 resulted in similar, immediate, robust, dose-dependent elevations in apoA-I and cholesterol efflux capacity in both renal function cohorts and significantly greater elevations in pre-β1-HDL (P < .05) in moderate renal impairment. Lecithin-cholesterol acyltransferase activity, demonstrated by a time-dependent change in the ratio of unesterified to esterified cholesterol, did not differ by renal function. No meaningful changes in proatherogenic lipid levels were observed. Moderate renal impairment did not impact the ability of CSL112 to enhance cholesterol efflux capacity. CSL112 may represent a novel therapy to reduce the risk of early recurrent cardiovascular events following acute myocardial infarction in patients with or without moderate renal impairment.",2019,CSL112 may represent a novel therapy to reduce the risk of early recurrent cardiovascular events following acute myocardial infarction in patients with or without moderate renal impairment.,"['Sixteen subjects with moderate renal impairment and 16 age-, sex-, and weight-matched subjects with normal renal function participated in the study', 'patients with or without moderate renal impairment', 'acute myocardial infarction patients']","['CSL112', 'placebo', 'CSL112 6 g (n\xa0=\xa06) or placebo', 'CSL112 (apolipoprotein A-I [human', 'CSL112 2 g ']","['Moderate renal impairment', 'proatherogenic lipid levels', 'moderate renal impairment', 'total cholesterol efflux, ABCA1-dependent cholesterol efflux capacity, and pre-β1-high-density lipoprotein (HDL) levels', 'Lecithin-cholesterol acyltransferase activity']","[{'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C1565489', 'cui_str': 'Renal Insufficiency'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0232805', 'cui_str': 'Normal renal function (finding)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction (disorder)'}]","[{'cui': 'C3712106', 'cui_str': 'CSL112'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1722869', 'cui_str': '(glycyl-prolyl-glycyl-glycyl-alanyl)6-glycine'}, {'cui': 'C0622790', 'cui_str': 'Apo A-I (Giessen)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C1565489', 'cui_str': 'Renal Insufficiency'}, {'cui': 'C0428460', 'cui_str': 'Finding of lipid level (finding)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement (procedure)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0023194', 'cui_str': 'Lecithin Cholesterol Acyltransferase'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}]",16.0,0.056581,CSL112 may represent a novel therapy to reduce the risk of early recurrent cardiovascular events following acute myocardial infarction in patients with or without moderate renal impairment.,"[{'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Gille', 'Affiliation': 'CSL Behring, Pasadena, CA, USA.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Duffy', 'Affiliation': 'CSL Behring, King of Prussia, PA, USA.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Tortorici', 'Affiliation': 'CSL Behring, King of Prussia, PA, USA.'}, {'ForeName': 'Samuel D', 'Initials': 'SD', 'LastName': 'Wright', 'Affiliation': 'CSL Behring, King of Prussia, PA, USA.'}, {'ForeName': 'Lawrence I', 'Initials': 'LI', 'LastName': 'Deckelbaum', 'Affiliation': 'CSL Behring, King of Prussia, PA, USA.'}, {'ForeName': 'Denise M', 'Initials': 'DM', 'LastName': ""D'Andrea"", 'Affiliation': 'CSL Behring, King of Prussia, PA, USA.'}]",Journal of clinical pharmacology,['10.1002/jcph.1337'] 947,32298728,Palivizumab Following Extremely Premature Birth Does Not Affect Pulmonary Outcomes in Adolescence.,"BACKGROUND Prematurity is a risk factor for impaired lung function. We sought to assess the long-term effect of palivizumab immunization and extreme prematurity (<29 weeks gestation) on respiratory symptoms and pulmonary function in adolescence. RESEARCH QUESTIONS What is the long-term effect of palivizumab immunization and extreme prematurity (<29 weeks) on respiratory symptoms and pulmonary function in adolescence? STUDY DESIGN AND METHODS We examined survivors of extreme prematurity (<29 weeks gestation) at 13 to 18 years of age (study group). Study group babies who were born immediately before palivizumab immunization (nonpalivizumab group [NPG]) were compared with those babies who were born just after implementation (PG) and with a control group. For study group patients, lung function in adolescence was further compared longitudinally with that at primary school age. RESULTS Sixty-four adolescents aged 15.76 ± 1.52 years were included: 46 in the study group (17 PG and 29 NPG) and 18 in the control group. For the study group, wheezing episodes, inhaler use, and hospitalizations were uncommon. For the study group compared with the control group, FEV 1 percent predicted was 82.60% ± 13.54% vs 105.83% ± 13.12% (P < .001), and the lung clearance index was 7.67 ± 1.02 vs 7.46 ± 0.70 (P = .48), respectively. Study group adolescents with bronchopulmonary dysplasia had a higher lung clearance index than did adolescents with no bronchopulmonary dysplasia (7.94 ± 1.11 vs 7.20 ± 0.60; P = .002). PG and NPG adolescents were not significantly different. Comparing the study group in adolescence with primary school age, we found improvement in mean FEV 1 percent predicted bronchodilator response (0.37% ± 9.98% vs 5.67% ± 9.87%; P = .036) and mean provocative concentration causing 20% decline in FEV 1 (12.16 ± 4.71 mg/mL vs 4.14 ± 4.51 mg/mL, respectively; P < .001). INTERPRETATION Palivizumab did not provide any discernable long-term protective effect. Nevertheless, adolescent survivors of extreme prematurity showed good clinical and physiologic outcomes, except for mildly raised lung clearance index in patients with bronchopulmonary dysplasia. Airway hyperreactivity detected at primary school age, decreased by adolescence.",2020,"For the study group compared with the control group, FEV 1 percent predicted was 82.60% ± 13.54% vs 105.83% ± 13.12% (P < .001), and the lung clearance index was 7.67 ± 1.02 vs 7.46 ± 0.70","['Adolescents', 'patients with bronchopulmonary dysplasia', 'Sixty-four adolescents aged 15.76 ± 1.52 years were included: 46 in the study group (17 PG and 29 NPG) and 18 in the control group', 'Extremely Premature Birth', 'survivors of extreme prematurity (<29\xa0weeks gestation) at 13 to 18 years of age (study group']","['palivizumab immunization (nonpalivizumab group [NPG', 'palivizumab immunization and extreme prematurity (<29\xa0weeks gestation', 'Palivizumab']","['respiratory symptoms and pulmonary function at adolescence', 'lung clearance index', 'Airway hyperreactivity', 'bronchodilator response', 'mean provocative concentration', 'lung function at adolescence', 'wheezing episodes, inhaler use, and hospitalizations']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006287', 'cui_str': 'Bronchopulmonary dysplasia of newborn'}, {'cui': 'C4517839', 'cui_str': '64'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0068260', 'cui_str': 'N-palmitoylgalactosylsphingosine'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205403', 'cui_str': 'Extreme'}, {'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}]","[{'cui': 'C0672596', 'cui_str': 'palivizumab'}, {'cui': 'C0020971', 'cui_str': 'Immunization'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0068260', 'cui_str': 'N-palmitoylgalactosylsphingosine'}, {'cui': 'C0205403', 'cui_str': 'Extreme'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}]","[{'cui': 'C0037090', 'cui_str': 'Respiratory symptom'}, {'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0231990', 'cui_str': 'Lung clearance index'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0006280', 'cui_str': 'Bronchodilator agent'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0043144', 'cui_str': 'Wheezing'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0021461', 'cui_str': 'Inhaler'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}]",64.0,0.149305,"For the study group compared with the control group, FEV 1 percent predicted was 82.60% ± 13.54% vs 105.83% ± 13.12% (P < .001), and the lung clearance index was 7.67 ± 1.02 vs 7.46 ± 0.70","[{'ForeName': 'Nofar', 'Initials': 'N', 'LastName': 'Amitai', 'Affiliation': ""Pulmonary Institute, Schneider Children's Medical Center of Israel, Petah Tikva.""}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Stafler', 'Affiliation': ""Pulmonary Institute, Schneider Children's Medical Center of Israel, Petah Tikva; Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv.""}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Blau', 'Affiliation': ""Pulmonary Institute, Schneider Children's Medical Center of Israel, Petah Tikva; Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv.""}, {'ForeName': 'Eytan', 'Initials': 'E', 'LastName': 'Kaplan', 'Affiliation': ""Pediatric Intensive Care Unit, Schneider Children's Medical Center of Israel, Petah Tikva; Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv.""}, {'ForeName': 'Huda', 'Initials': 'H', 'LastName': 'Mussaffi', 'Affiliation': ""Pulmonary Institute, Schneider Children's Medical Center of Israel, Petah Tikva; Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv.""}, {'ForeName': 'Hagit', 'Initials': 'H', 'LastName': 'Levine', 'Affiliation': ""Pulmonary Institute, Schneider Children's Medical Center of Israel, Petah Tikva; Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv.""}, {'ForeName': 'Guy', 'Initials': 'G', 'LastName': 'Steuer', 'Affiliation': ""Pulmonary Institute, Schneider Children's Medical Center of Israel, Petah Tikva.""}, {'ForeName': 'Ephraim', 'Initials': 'E', 'LastName': 'Bar-Yishay', 'Affiliation': 'Faculty of Health Sciences, Ben Gurion University of the Negev, Beer Sheba, Israel.'}, {'ForeName': 'Gil', 'Initials': 'G', 'LastName': 'Klinger', 'Affiliation': ""Neonatal Intensive Care Unit, Schneider Children's Medical Center of Israel, Petah Tikva; Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv.""}, {'ForeName': 'Meir', 'Initials': 'M', 'LastName': 'Mei-Zahav', 'Affiliation': ""Pulmonary Institute, Schneider Children's Medical Center of Israel, Petah Tikva; Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv.""}, {'ForeName': 'Dario', 'Initials': 'D', 'LastName': 'Prais', 'Affiliation': ""Pulmonary Institute, Schneider Children's Medical Center of Israel, Petah Tikva; Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv. Electronic address: prais@tauex.tau.ac.il.""}]",Chest,['10.1016/j.chest.2020.02.075'] 948,31004462,Sunscreen or simulated sweat minimizes the impact of acute ultraviolet radiation on cutaneous microvascular function in healthy humans.,"NEW FINDINGS What is the central question of this study? Are ultraviolet radiation (UVR)-induced increases in skin blood flow independent of skin erythema? Does broad-spectrum UVR exposure attenuate NO-mediated cutaneous vasodilatation, and does sunscreen or sweat modulate this response? What are the main findings and their importance? Erythema and vascular responses to UVR are temporally distinct, and sunscreen prevents both responses. Exposure to UVR attenuates NO-mediated vasodilatation in the cutaneous microvasculature; sunscreen or simulated sweat on the skin attenuates this response. Sun over-exposure may elicit deleterious effects on human skin that are separate from sunburn, and sunscreen or sweat on the skin may provide protection. ABSTRACT Exposure to ultraviolet radiation (UVR) may result in cutaneous vascular dysfunction independent of erythema (skin reddening). Two studies were designed to differentiate changes in erythema from skin vasodilatation throughout the 8 h after acute broad-spectrum UVR exposure with (+SS) or without SPF-50 sunscreen (study 1) and to examine NO-mediated cutaneous vasodilatation after acute broad-spectrum UVR exposure with or without +SS or simulated sweat (+SW) on the skin (study 2). In both studies, laser-Doppler flowmetry was used to measure red cell flux, and cutaneous vascular conductance (CVC) was calculated (CVC = flux/mean arterial pressure). In study 1, in 14 healthy adults (24 ± 4 years old; seven men and seven women), the skin erythema index and CVC were measured over two forearm sites (UVR only and UVR+SS) before, immediately after and every 2 h for 8 h post-exposure (750 mJ cm -2 ). The erythema index began to increase immediately post-UVR (P < 0.05 at 4, 6 and 8 h), but CVC did not increase above baseline for the first 4-6 h (P ≤ 0.01 at 6 and 8 h); +SS prevented both responses. In study 2, in 13 healthy adults (24 ± 4 years old; six men and seven women), three intradermal microdialysis fibres were placed in the ventral skin of the forearm [randomly assigned to UVR (450 mJ cm -2 ), UVR+SS or UVR+SW], and one fibre (non-exposed control; CON) was placed in the contralateral forearm. After UVR, a standardized local heating (42°C) protocol quantified the percentage of NO-mediated vasodilatation (%NO). The UVR attenuated %NO compared with CON (P = 0.01). The diminished %NO was prevented by +SS (P < 0.01) and +SW (P < 0.01). Acute broad-spectrum UVR attenuates NO-dependent dilatation in the cutaneous microvasculature, independent of erythema. Sunscreen protects against both inflammatory and heating-induced endothelial dysfunction, and sweat might prevent UVR-induced reductions in NO-dependent dilatation.",2019,The diminished %NO was prevented by +SS (P < 0.01) and +SW (P < 0.01).,"['healthy humans', 'cutaneous vascular dysfunction independent of erythema (skin reddening', '14 healthy adults (24\xa0±\xa04\xa0years old; seven men and seven women', '13 healthy adults (24\xa0±\xa04\xa0years old; six men and seven women']","['CON', 'Sunscreen or simulated sweat', 'spectrum UVR exposure with or without +SS or simulated sweat (+SW', 'intradermal microdialysis fibres were placed in the ventral skin of the forearm [randomly assigned to UVR (450\xa0mJ\xa0cm -2 ), UVR+SS or UVR+SW], and one fibre (non-exposed control; CON', 'acute ultraviolet radiation', 'ultraviolet radiation (UVR', 'laser-Doppler flowmetry', 'SPF-50 sunscreen']","['red cell flux, and cutaneous vascular conductance (CVC', 'Erythema and vascular responses', 'erythema index', 'skin erythema index and CVC']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C4521174', 'cui_str': 'Cutaneous'}, {'cui': 'C0031847', 'cui_str': 'pathophysiology'}, {'cui': 'C0332291', 'cui_str': 'Independent of (attribute)'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C0038818', 'cui_str': 'Sunscreens'}, {'cui': 'C0038990', 'cui_str': 'Sweating'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0206056', 'cui_str': 'Microdialysis'}, {'cui': 'C0225326', 'cui_str': 'Fiber'}, {'cui': 'C1704765', 'cui_str': 'Place - dosing instruction imperative'}, {'cui': 'C1704448', 'cui_str': 'Ventral'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0016536', 'cui_str': 'Antebrachiums'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C3844104', 'cui_str': 'Four hundred and fifty'}, {'cui': 'C0332157', 'cui_str': 'Exposure to (contextual qualifier) (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C4319812', 'cui_str': 'Ultraviolet Radiation'}, {'cui': 'C0162520', 'cui_str': 'Laser-Doppler Flowmetry'}]","[{'cui': 'C0332575', 'cui_str': 'Red color (finding)'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C4521174', 'cui_str': 'Cutaneous'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",14.0,0.0168513,The diminished %NO was prevented by +SS (P < 0.01) and +SW (P < 0.01).,"[{'ForeName': 'S Tony', 'Initials': 'ST', 'LastName': 'Wolf', 'Affiliation': 'Department of Kinesiology, The Pennsylvania State University, University Park, PA, USA.'}, {'ForeName': 'Craig W', 'Initials': 'CW', 'LastName': 'Berry', 'Affiliation': 'Department of Kinesiology, The Pennsylvania State University, University Park, PA, USA.'}, {'ForeName': 'Anna E', 'Initials': 'AE', 'LastName': 'Stanhewicz', 'Affiliation': 'Department of Kinesiology, The Pennsylvania State University, University Park, PA, USA.'}, {'ForeName': 'Lauren E', 'Initials': 'LE', 'LastName': 'Kenney', 'Affiliation': 'Department of Kinesiology, The Pennsylvania State University, University Park, PA, USA.'}, {'ForeName': 'Sara B', 'Initials': 'SB', 'LastName': 'Ferguson', 'Affiliation': 'Department of Kinesiology, The Pennsylvania State University, University Park, PA, USA.'}, {'ForeName': 'W Larry', 'Initials': 'WL', 'LastName': 'Kenney', 'Affiliation': 'Department of Kinesiology, The Pennsylvania State University, University Park, PA, USA.'}]",Experimental physiology,['10.1113/EP087688'] 949,31866161,Can Kinesio Taping® influence the electromyographic signal intensity of trunk extensor muscles in patients with chronic low back pain? A randomized controlled trial.,"BACKGROUND The evidence of the influence of Kinesio Taping® in changing electromyographic signal intensity of the lumbar musculature in patients with chronic non-specific low back pain (LBP) is very sparse. OBJECTIVES To evaluate if Kinesio Taping® changes the electromyographic signal intensity of the longissimus and iliocostalis muscles in patients with chronic non-specific LBP. METHODS Prospectively registered, three-arm randomized controlled trial with a blinded assessor. Patients were randomly allocated to the following interventions: 1) Kinesio Taping® Group (n=21), where patients received the tape according to the manufacturer's manual; 2) Placebo Group (i.e. normal surgical tape) (n=21); and 3) Non-treatment control Group (n=21). Assessments were performed at baseline, immediately after, and 30min after the intervention. The primary outcome was muscle activity of the iliocostalis and longissimus muscles as measured by surface electromyography. The secondary outcome was pain intensity (measured with a 0-10 Numerical Rating Scale). The effects of treatment were calculated using linear mixed models. RESULTS A total of 63 patients were recruited. Follow up rate was high (98.4%). Patients were mostly women with moderate levels of pain and disability. Kinesio Taping® was better than the control and placebo groups in only 4 of 96 statistical comparisons, likely reflective of type I error due to multiple comparisons. No statistically significant differences were identified for the immediate reduction in pain intensity between groups. CONCLUSION Kinesio Taping® did not change the electromyographic signal intensity of the longissimus and iliocostalis muscles or reduce pain intensity in patients with chronic low back pain. Clinicaltrials.gov: NCT02759757 (https://clinicaltrials.gov/ct2/show/NCT02759757).",2019,Kinesio Taping® did not change the electromyographic signal intensity of the longissimus and iliocostalis muscles or reduce pain intensity in patients with chronic low back pain.,"['patients with chronic non-specific low back pain (LBP', 'A total of 63 patients were recruited', 'patients with chronic low back pain', 'Patients were mostly women with moderate levels of pain and disability', 'patients with chronic non-specific LBP']","['placebo', 'Kinesio Taping® Group', 'Kinesio Taping®', 'Placebo Group (i.e. normal surgical tape']","['electromyographic signal intensity', 'pain intensity', 'muscle activity of the iliocostalis and longissimus muscles as measured by surface electromyography', 'pain intensity (measured with a 0-10 Numerical Rating Scale']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0205370', 'cui_str': 'Non-specific (qualifier value)'}, {'cui': 'C0024031', 'cui_str': 'Low Back Ache'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0183837', 'cui_str': 'Surgical Tape'}]","[{'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0224306', 'cui_str': 'Structure of longissimus muscle'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0430815', 'cui_str': 'Surface Electromyography'}, {'cui': 'C0222045'}]",96.0,0.281065,Kinesio Taping® did not change the electromyographic signal intensity of the longissimus and iliocostalis muscles or reduce pain intensity in patients with chronic low back pain.,"[{'ForeName': 'Leandro Garcia', 'Initials': 'LG', 'LastName': 'Pires', 'Affiliation': 'Masters and Doctoral Programs in Physical Therapy, Universidade Cidade de São Paulo (UNICID), São Paulo, SP, Brazil.'}, {'ForeName': 'Rosimeire Simprini', 'Initials': 'RS', 'LastName': 'Padula', 'Affiliation': 'Masters and Doctoral Programs in Physical Therapy, Universidade Cidade de São Paulo (UNICID), São Paulo, SP, Brazil.'}, {'ForeName': 'Maurício Antônio Da Luz', 'Initials': 'MADL', 'LastName': 'Junior', 'Affiliation': 'Masters and Doctoral Programs in Physical Therapy, Universidade Cidade de São Paulo (UNICID), São Paulo, SP, Brazil.'}, {'ForeName': 'Irlei', 'Initials': 'I', 'LastName': 'Santos', 'Affiliation': 'Masters and Doctoral Programs in Physical Therapy, Universidade Cidade de São Paulo (UNICID), São Paulo, SP, Brazil.'}, {'ForeName': 'Matheus Oliveira', 'Initials': 'MO', 'LastName': 'Almeida', 'Affiliation': 'Masters and Doctoral Programs in Physical Therapy, Universidade Cidade de São Paulo (UNICID), São Paulo, SP, Brazil.'}, {'ForeName': 'Shaiane Silva', 'Initials': 'SS', 'LastName': 'Tomazoni', 'Affiliation': 'Masters and Doctoral Programs in Physical Therapy, Universidade Cidade de São Paulo (UNICID), São Paulo, SP, Brazil.'}, {'ForeName': 'Lucíola Cunha Menezes', 'Initials': 'LCM', 'LastName': 'Costa', 'Affiliation': 'Masters and Doctoral Programs in Physical Therapy, Universidade Cidade de São Paulo (UNICID), São Paulo, SP, Brazil.'}, {'ForeName': 'Leonardo Oliveira Pena', 'Initials': 'LOP', 'LastName': 'Costa', 'Affiliation': 'Masters and Doctoral Programs in Physical Therapy, Universidade Cidade de São Paulo (UNICID), São Paulo, SP, Brazil. Electronic address: lcos3060@gmail.com.'}]",Brazilian journal of physical therapy,['10.1016/j.bjpt.2019.12.001'] 950,31249394,Urine protein:creatinine ratio vs 24-hour urine protein for proteinuria management: analysis from the phase 3 REFLECT study of lenvatinib vs sorafenib in hepatocellular carcinoma.,"BACKGROUND Proteinuria monitoring is required in patients receiving lenvatinib, however, current methodology involves burdensome overnight urine collection. METHODS To determine whether the simpler urine protein:creatinine ratio (UPCR) calculated from spot urine samples could be accurately used for proteinuria monitoring in patients receiving lenvatinib, we evaluated the correlation between UPCR and 24-hour urine protein results from the phase 3 REFLECT study. Paired data (323 tests, 154 patients) were analysed. RESULTS Regression analysis showed a statistically significant correlation between UPCR and 24-hour urine protein (R 2 : 0.75; P < 2 × 10 -16 ). A UPCR cut-off value of 2.4 had 96.9% sensitivity, 82.5% specificity for delineating between grade 2 and 3 proteinuria. Using this UPCR cut-off value to determine the need for further testing could reduce the need for 24-hour urine collection in ~74% of patients. CONCLUSION Incorporation of UPCR into the current algorithm for proteinuria management can enable optimisation of lenvatinib treatment, while minimising patient inconvenience. CLINICAL TRIAL REGISTRATION NCT01761266.",2019,"A UPCR cut-off value of 2.4 had 96.9% sensitivity, 82.5% specificity for delineating between grade 2 and 3 proteinuria.",['hepatocellular carcinoma'],['lenvatinib vs sorafenib'],['UPCR and 24-hour urine protein'],"[{'cui': 'C2239176', 'cui_str': 'Liver Cell Carcinoma, Adult'}]","[{'cui': 'C2986924', 'cui_str': 'lenvatinib'}, {'cui': 'C1516119', 'cui_str': 'sorafenib'}]","[{'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C1305628', 'cui_str': 'Urine protein (substance)'}]",,0.0399609,"A UPCR cut-off value of 2.4 had 96.9% sensitivity, 82.5% specificity for delineating between grade 2 and 3 proteinuria.","[{'ForeName': 'Thomas R Jeffry', 'Initials': 'TRJ', 'LastName': 'Evans', 'Affiliation': 'University of Glasgow, Beatson West of Scotland Cancer Centre, Glasgow, UK. j.evans@beatson.gla.ac.uk.'}, {'ForeName': 'Masatoshi', 'Initials': 'M', 'LastName': 'Kudo', 'Affiliation': 'Department of Gastroenterology and Hepatology, Kindai University Faculty of Medicine, Osaka, Japan.'}, {'ForeName': 'Richard S', 'Initials': 'RS', 'LastName': 'Finn', 'Affiliation': 'David Geffen School of Medicine, UCLA Medical Center, Los Angeles, CA, USA.'}, {'ForeName': 'Kwang-Hyub', 'Initials': 'KH', 'LastName': 'Han', 'Affiliation': 'Severance Hospital, Yonsei University, Seoul, South Korea.'}, {'ForeName': 'Ann-Lii', 'Initials': 'AL', 'LastName': 'Cheng', 'Affiliation': 'National Taiwan University Hospital and National Taiwan University Cancer Center, Taipei, Taiwan.'}, {'ForeName': 'Masafumi', 'Initials': 'M', 'LastName': 'Ikeda', 'Affiliation': 'Department of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital East, Kashiwa, Japan.'}, {'ForeName': 'Silvija', 'Initials': 'S', 'LastName': 'Kraljevic', 'Affiliation': 'Former employee of Eisai Ltd, Hatfield, UK.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Ren', 'Affiliation': 'Eisai Inc., Woodcliff Lake, NJ, USA.'}, {'ForeName': 'Corina E', 'Initials': 'CE', 'LastName': 'Dutcus', 'Affiliation': 'Eisai Inc., Woodcliff Lake, NJ, USA.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Piscaglia', 'Affiliation': 'Unit of Internal Medicine, University of Bologna, S.Orsola-Malpighi Hospital, Bologna, Italy.'}, {'ForeName': 'Max W', 'Initials': 'MW', 'LastName': 'Sung', 'Affiliation': 'Tisch Cancer Institute at Mount Sinai, New York, NY, USA.'}]",British journal of cancer,['10.1038/s41416-019-0506-6'] 951,31257574,Fortification of wheat and maize flour with folic acid for population health outcomes.,"BACKGROUND Folate is a B-vitamin required for DNA synthesis, methylation, and cellular division. Wheat and maize (corn) flour are staple crops consumed widely throughout the world and have been fortified with folic acid in over 80 countries to prevent neural tube defects. Folic acid fortification may be an effective strategy to improve folate status and other health outcomes in the overall population. OBJECTIVES To evaluate the health benefits and safety of folic acid fortification of wheat and maize flour (i.e. alone or in combination with other micronutrients) on folate status and health outcomes in the overall population, compared to wheat or maize flour without folic acid (or no intervention). SEARCH METHODS We searched the following databases in March and May 2018: Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE and MEDLINE In Process, Embase, CINAHL, Web of Science (SSCI, SCI), BIOSIS, Popline, Bibliomap, TRoPHI, ASSIA, IBECS, SCIELO, Global Index Medicus-AFRO and EMRO, LILACS, PAHO, WHOLIS, WPRO, IMSEAR, IndMED, and Native Health Research Database. We searched the International Clinical Trials Registry Platform and ClinicalTrials.gov for ongoing or planned studies in June 2018, and contacted authors for further information. SELECTION CRITERIA We included randomised controlled trials (RCTs), with randomisation at the individual or cluster level. We also included non-RCTs and prospective observational studies with a control group; these studies were not included in meta-analyses, although their characteristics and findings were described. Interventions included wheat or maize flour fortified with folic acid (i.e. alone or in combination with other micronutrients), compared to unfortified flour (or no intervention). Participants were individuals over two years of age (including pregnant and lactating women), from any country. DATA COLLECTION AND ANALYSIS Two review authors independently assessed study eligibility, extracted data, and assessed risk of bias. MAIN RESULTS We included 10 studies: four provided data for quantitative analyses (437 participants); five studies were randomised trials (1182 participants); three studies were non-RCTs (1181 participants, 8037 live births); two studies were interrupted time series (ITS) studies (1 study population of 2,242,438, 1 study unreported). Six studies were conducted in upper-middle-income countries (China, Mexico, South Africa), one study was conducted in a lower-middle-income country (Bangladesh), and three studies were conducted in a high-income country (Canada). Seven studies examined wheat flour fortified with folic acid alone or with other micronutrients. Three studies included maize flour fortified with folic acid alone or with other micronutrients. The duration of interventions ranged from two weeks to 36 months, and the ITS studies included postfortification periods of up to seven years. Most studies had unclear risk of bias for randomisation, blinding, and reporting, and low/unclear risk of bias for attrition and contamination.Neural tube defects: none of the included RCTs reported neural tube defects as an outcome. In one non-RCT, wheat flour fortified with folic acid and other micronutrients was associated with significantly lower occurrence of total neural tube defects, spina bifida, and encephalocoele, but not anencephaly, compared to unfortified flour (total neural tube defects risk ratio (RR) 0.32, 95% confidence interval (CI) 0.21 to 0.48; 1 study, 8037 births; low-certainty evidence).Folate status: pregnant women who received folic acid-fortified maize porridge had significantly higher erythrocyte folate concentrations (mean difference (MD) 238.90 nmol/L, 95% CI 149.40 to 328.40); 1 study, 38 participants; very low-certainty evidence) and higher plasma folate (MD 14.98 nmol/L, 95% CI 9.63 to 20.33; 1 study, 38 participants; very low-certainty evidence), compared to no intervention. Women of reproductive age consuming maize flour fortified with folic acid and other micronutrients did not have higher erythrocyte folate (MD -61.80 nmol/L, 95% CI -152.98 to 29.38; 1 study, 35 participants; very low-certainty evidence) or plasma folate (MD 0.00 nmol/L, 95% CI -0.00 to 0.00; 1 study, 35 participants; very low-certainty evidence) concentrations, compared to women consuming unfortified maize flour. Adults consuming folic acid-fortified wheat flour bread rolls had higher erythrocyte folate (MD 0.66 nmol/L, 95% CI 0.13 to 1.19; 1 study, 30 participants; very low-certainty evidence) and plasma folate (MD 27.00 nmol/L, 95% CI 15.63 to 38.37; 1 study, 30 participants; very low-certainty evidence), versus unfortified flour. In two non-RCTs, serum folate concentrations were significantly higher among women who consumed flour fortified with folic acid and other micronutrients compared to women who consumed unfortified flour (MD 2.92 nmol/L, 95% CI 1.99 to 3.85; 2 studies, 657 participants; very low-certainty evidence).Haemoglobin or anaemia: in a cluster-randomised trial among children, there were no significant effects of fortified wheat flour flatbread on haemoglobin concentrations (MD 0.00 nmol/L, 95% CI -2.08 to 2.08; 1 study, 334 participants; low-certainty evidence) or anaemia (RR 1.07, 95% CI 0.74 to 1.55; 1 study, 334 participants; low-certainty evidence), compared to unfortified wheat flour flatbread. AUTHORS' CONCLUSIONS Fortification of wheat flour with folic acid may reduce the risk of neural tube defects; however, this outcome was only reported in one non-RCT. Fortification of wheat or maize flour with folic acid (i.e. alone or with other micronutrients) may increase erythrocyte and serum/plasma folate concentrations. Evidence is limited for the effects of folic acid-fortified wheat or maize flour on haemoglobin levels or anaemia. The effects of folic acid fortification of wheat or maize flour on other primary outcomes assessed in this review is not known. No studies reported on the occurrence of adverse effects. Limitations of this review were the small number of studies and participants, limitations in study design, and low-certainty of evidence due to how included studies were designed and reported.",2019,"Adults consuming folic acid-fortified wheat flour bread rolls had higher erythrocyte folate (MD 0.66 nmol/L, 95% CI 0.13 to 1.19; 1 study, 30 participants; very low-certainty evidence) and plasma folate (MD 27.00 nmol/L, 95% CI 15.63 to 38.37; 1 study, 30 participants; very low-certainty evidence), versus unfortified flour.","['Six studies were conducted in upper-middle-income countries (China, Mexico, South Africa), one study was conducted in a lower-middle-income country (Bangladesh), and three studies were conducted in a high-income country (Canada', 'Participants were individuals over two years of age (including pregnant and lactating women), from any country', '10 studies: four provided data for quantitative analyses (437 participants); five studies were randomised trials (1182 participants); three studies were non-RCTs (1181 participants, 8037 live births); two studies were interrupted time series (ITS) studies (1 study population of 2,242,438, 1 study unreported']","['folic acid fortification of wheat and maize flour (i.e. alone or in combination with other micronutrients', 'Fortification of wheat flour with folic acid', 'folic acid fortification of wheat or maize flour', 'folic acid-fortified wheat or maize flour', 'wheat flour fortified with folic acid alone', 'wheat or maize flour fortified with folic acid (i.e. alone or in combination with other micronutrients), compared to unfortified flour (or no intervention', 'Fortification of wheat or maize flour with folic acid', 'Wheat and maize (corn) flour', 'Fortification of wheat and maize flour with folic acid', 'wheat or maize flour without folic acid (or no intervention', 'folic acid alone or with other micronutrients', 'folic acid', 'Folic acid fortification']","['low-certainty evidence).Haemoglobin or anaemia', 'erythrocyte folate', 'serum folate concentrations', 'occurrence of total neural tube defects, spina bifida, and encephalocoele', 'anaemia', 'plasma folate', 'folate status and health outcomes', 'erythrocyte and serum/plasma folate concentrations', 'erythrocyte folate concentrations', 'haemoglobin concentrations', 'risk of neural tube defects', 'haemoglobin levels or anaemia', 'Embase, CINAHL, Web of Science (SSCI, SCI), BIOSIS, Popline, Bibliomap, TRoPHI, ASSIA, IBECS, SCIELO, Global Index Medicus-AFRO and EMRO, LILACS, PAHO, WHOLIS, WPRO, IMSEAR, IndMED', 'occurrence of adverse effects']","[{'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}, {'cui': 'C0025885', 'cui_str': 'Mexico'}, {'cui': 'C0037712', 'cui_str': 'Union of South Africa'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0948433', 'cui_str': 'High income'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0549206', 'cui_str': 'Pregnancy not delivered'}, {'cui': 'C0202115', 'cui_str': 'Lactic acid measurement (procedure)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0392762', 'cui_str': 'Quantitative (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0481667', 'cui_str': 'Live Birth'}, {'cui': 'C3850092', 'cui_str': 'Interrupted Time Series'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0016410', 'cui_str': 'Folic Acid'}, {'cui': 'C0043137', 'cui_str': 'Wheat'}, {'cui': 'C0010028', 'cui_str': 'Zea mays'}, {'cui': 'C0016260', 'cui_str': 'Flour'}, {'cui': 'C0282575', 'cui_str': 'Micronutrients'}, {'cui': 'C0458980', 'cui_str': 'Wheat flour (substance)'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0439543', 'cui_str': 'Certainties (qualifier value)'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0014792', 'cui_str': 'Blood Corpuscles, Red'}, {'cui': 'C0178638', 'cui_str': 'Folate'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0027794', 'cui_str': 'Developmental Defects, Neural Tube'}, {'cui': 'C0080178', 'cui_str': 'Schistorrhachis'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1318517', 'cui_str': 'Hemoglobin concentration, dipstick - finding'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0036397', 'cui_str': 'Science'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0021194', 'cui_str': 'Index Medicus'}, {'cui': 'C0030260', 'cui_str': 'PAHO'}, {'cui': 'C0001688', 'cui_str': 'side effects'}]",38.0,0.246925,"Adults consuming folic acid-fortified wheat flour bread rolls had higher erythrocyte folate (MD 0.66 nmol/L, 95% CI 0.13 to 1.19; 1 study, 30 participants; very low-certainty evidence) and plasma folate (MD 27.00 nmol/L, 95% CI 15.63 to 38.37; 1 study, 30 participants; very low-certainty evidence), versus unfortified flour.","[{'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Centeno Tablante', 'Affiliation': 'Division of Nutritional Sciences, Cornell University, Ithaca, New York, USA.'}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Pachón', 'Affiliation': ''}, {'ForeName': 'Heather M', 'Initials': 'HM', 'LastName': 'Guetterman', 'Affiliation': ''}, {'ForeName': 'Julia L', 'Initials': 'JL', 'LastName': 'Finkelstein', 'Affiliation': ''}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD012150.pub2'] 952,31259807,"PATIENT-REPORTED VISUAL FUNCTION FROM THE OCRIPLASMIN FOR TREATMENT FOR SYMPTOMATIC VITREOMACULAR ADHESION, INCLUDING MACULAR HOLE (OASIS) STUDY.","PURPOSE To evaluate patient-reported visual function after ocriplasmin through the 25-item National Eye Institute Visual Function Questionnaire (VFQ-25) in patients with symptomatic vitreomacular adhesion/vitreomacular traction including macular hole. METHODS This was a prespecified analysis of a secondary endpoint from the OASIS trial. Patients received a single intravitreal injection of ocriplasmin (0.125 mg) or sham and completed the VFQ-25 questionnaire at baseline and at Months 6, 12, and 24. Clinically meaningful (≥5-point) changes from baseline were assessed. RESULTS Of the 220 patients enrolled, 146 received ocriplasmin and 74 received sham. At Month 24, the percentage of patients with a ≥5-point improvement from baseline in VFQ-25 composite scores was higher with ocriplasmin versus sham (51.4% vs. 30.1%, 95% confidence interval, 8.1-34.5, P = 0.003). The percentage of patients with ≥5-point worsening at Month 24 was lower with ocriplasmin versus sham (9.5% vs. 15.6%, 95% confidence interval: -15.6 to 3.5, P = 0.191). A larger percentage of patients treated with ocriplasmin versus sham experienced a ≥5-point improvement in VFQ-25 composite and subscale scores at Month 24 regardless of baseline full-thickness macular hole status. CONCLUSION A larger percentage of patients with symptomatic vitreomacular adhesion/vitreomacular traction reported clinically meaningful improvements in self-assessed visual function with ocriplasmin than sham.",2020,"A larger percentage of patients treated with ocriplasmin versus sham experienced a ≥5-point improvement in VFQ-25 composite and subscale scores at Month 24 regardless of baseline full-thickness macular hole status. ","['patients with symptomatic vitreomacular adhesion/vitreomacular traction including macular hole', '220 patients enrolled, 146 received']","['ocriplasmin', 'ocriplasmin through the 25-item National Eye Institute Visual Function Questionnaire (VFQ-25', 'single intravitreal injection of ocriplasmin']","['percentage of patients with ≥5-point worsening', 'self-assessed visual function', 'VFQ-25 composite scores', 'VFQ-25 composite and subscale scores']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C2748203', 'cui_str': 'Vitreomacular adhesion'}, {'cui': 'C0040597', 'cui_str': 'Traction'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0024441', 'cui_str': 'Macular Holes'}, {'cui': 'C4517650', 'cui_str': '220 (qualifier value)'}]","[{'cui': 'C0066522', 'cui_str': 'ocriplasmin'}, {'cui': 'C1955969', 'cui_str': 'NEI (US)'}, {'cui': 'C0042789', 'cui_str': 'Vision'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C1554888', 'cui_str': 'Intravitreal Injections'}]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0042789', 'cui_str': 'Vision'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0459443', 'cui_str': 'Subscale score (qualifier value)'}]",220.0,0.272427,"A larger percentage of patients treated with ocriplasmin versus sham experienced a ≥5-point improvement in VFQ-25 composite and subscale scores at Month 24 regardless of baseline full-thickness macular hole status. ","[{'ForeName': 'Calvin', 'Initials': 'C', 'LastName': 'Mein', 'Affiliation': 'Retinal Consultants of San Antonio, San Antonio, Texas.'}, {'ForeName': 'Pravin U', 'Initials': 'PU', 'LastName': 'Dugel', 'Affiliation': 'Retinal Consultants of Arizona, Phoenix, Arizona.'}, {'ForeName': 'Leonard', 'Initials': 'L', 'LastName': 'Feiner', 'Affiliation': 'Hackensack University Medical Center, Hackensack, New Jersey.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Drenser', 'Affiliation': 'Associated Retinal Consultants P.C., Royal Oak, Michigan.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Miller', 'Affiliation': 'Cincinnati Eye Institute, Cincinnati, Ohio.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Benz', 'Affiliation': 'Retinal Consultants Houston, Houston, Texas.'}, {'ForeName': 'Esmeralda', 'Initials': 'E', 'LastName': 'Meunier', 'Affiliation': 'Oxurion (formerly ThromboGenics), Leuven, Belgium.'}, {'ForeName': 'Lionel', 'Initials': 'L', 'LastName': 'Moro', 'Affiliation': 'Oxurion (formerly ThromboGenics), Leuven, Belgium.'}, {'ForeName': 'Mitchell S', 'Initials': 'MS', 'LastName': 'Fineman', 'Affiliation': 'Mid Atlantic Retina, Philadelphia, Pennsylvania.'}]","Retina (Philadelphia, Pa.)",['10.1097/IAE.0000000000002599'] 953,31260028,Effect of Stroke Education Pamphlets vs a 12-Minute Culturally Tailored Stroke Film on Stroke Preparedness Among Black and Hispanic Churchgoers: A Cluster Randomized Clinical Trial.,"Importance Black individuals and Hispanic individuals are less likely to recognize stroke and call 911 (stroke preparedness), contributing to racial/ethnic disparities in intravenous tissue plasminogen activator use. Objective To evaluate the effect of culturally tailored 12-minute stroke films on stroke preparedness vs the usual care practice of distributing stroke education pamphlets. Design, Setting, and Participants Cluster randomized clinical trial between July 26, 2013, and August 16, 2018, with randomization of 13 black and Hispanic churches located in urban neighborhoods to intervention or usual care. In total, 883 congregants were approached, 503 expressed interest, 375 completed eligibility screening, and 312 were randomized. Sixty-three individuals were ineligible (younger than 34 years and/or did not have at least 1 traditional stroke risk factor). Interventions Two 12-minute stroke films on stroke preparedness for black and Hispanic audiences. Main Outcomes and Measures The primary outcome was the Stroke Action Test (STAT), assessed at baseline, 6 months, and 12 months. Results In total, 261 of 312 individuals completed the study (83.7% retention rate). Most participants were female (79.1%). The mean (SD) age of participants was 58.57 (11.66) years; 51.1% (n = 159) were non-Hispanic black, 48.9% (n = 152) were Hispanic, and 31.7% (n = 99) had low levels of education. There were no significant end-point differences for the STAT at follow-up periods. The mean (SD) baseline STAT scores were 59.05% (29.12%) correct for intervention and 58.35% (28.83%) correct for usual care. At 12 months, the mean (SD) STAT scores were 64.38% (26.39%) correct for intervention and 61.58% (28.01%) correct for usual care. Adjusted by education, a post hoc subgroup analysis revealed a mean (SE) intervention effect of 1.03% (0.44%) (P = .02) increase per month in the low-education subgroup (about a 10% increase in 12 months). In the high-education subgroup, the mean (SE) intervention effect was -0.05% (0.30%) (P = .86). Regarding percentage correct, the low-education intervention subgroup improved from 52.4% (7 of 21) to 66.7% (14 of 21) compared with the other subgroups. Conclusions and Relevance No difference was observed in stroke preparedness at 12 months in response to culturally tailored 12-minute stroke films or conventional stroke education pamphlets. Additional studies are required to confirm findings from a post hoc subgroup analysis that suggested a significant education effect. Trial Registration ClinicalTrials.gov identifier: NCT01909271.",2019,No difference was observed in stroke preparedness at 12 months in response to culturally tailored 12-minute stroke films or conventional stroke education pamphlets.,"['In total, 261 of 312 individuals completed the study (83.7% retention rate', 'Participants\n\n\nCluster randomized clinical trial between July 26, 2013, and August 16, 2018, with randomization of 13 black and Hispanic churches located in urban neighborhoods to intervention or usual care', 'Sixty-three individuals were ineligible (younger than 34 years and/or did not have at least 1 traditional stroke risk factor', 'Black and Hispanic Churchgoers', 'In total, 883 congregants were approached, 503 expressed interest, 375 completed eligibility screening, and 312 were randomized', 'non-Hispanic black, 48.9% (n\u2009=\u2009152) were Hispanic, and 31.7% (n\u2009=\u200999) had low levels of education', 'The mean (SD) age of participants was 58.57 (11.66) years; 51.1% (n\u2009=\u2009159) were', 'Black individuals and Hispanic individuals']",['Stroke Education Pamphlets vs a 12-Minute Culturally Tailored Stroke Film'],"['mean (SD) baseline STAT scores', 'Stroke Action Test (STAT', 'mean (SD) STAT scores', 'stroke preparedness', 'mean (SE) intervention effect']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4517706', 'cui_str': '312 (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0206034', 'cui_str': 'Clinical Trials, Randomized'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0562324', 'cui_str': 'Church (environment)'}, {'cui': 'C0332285', 'cui_str': 'In (attribute)'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0027569', 'cui_str': 'Neighborhood'}, {'cui': 'C4319614', 'cui_str': '63 (qualifier value)'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C1277291', 'cui_str': 'Stroke risk'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C4517745', 'cui_str': '375 (qualifier value)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C4708784', 'cui_str': '31.7 (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C4303794', 'cui_str': 'Stroke education'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C4319646', 'cui_str': 'Film'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0205548', 'cui_str': 'Stat (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0441472', 'cui_str': 'Action (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C1318963', 'cui_str': 'Readiness'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}]",883.0,0.159017,No difference was observed in stroke preparedness at 12 months in response to culturally tailored 12-minute stroke films or conventional stroke education pamphlets.,"[{'ForeName': 'Olajide', 'Initials': 'O', 'LastName': 'Williams', 'Affiliation': 'Department of Neurology, Columbia University Medical Center, New York, New York.'}, {'ForeName': 'Jeanne', 'Initials': 'J', 'LastName': 'Teresi', 'Affiliation': 'Columbia University Stroud Center, New York State Psychiatric Institute, New York.'}, {'ForeName': 'Joseph P', 'Initials': 'JP', 'LastName': 'Eimicke', 'Affiliation': 'Research Division, Hebrew Home at Riverdale, Bronx, New York.'}, {'ForeName': 'Amparo', 'Initials': 'A', 'LastName': 'Abel-Bey', 'Affiliation': 'Department of Neurology, Columbia University Medical Center, New York, New York.'}, {'ForeName': 'Madeleine', 'Initials': 'M', 'LastName': 'Hassankhani', 'Affiliation': 'Department of Neurology, Columbia University Medical Center, New York, New York.'}, {'ForeName': 'Lenfis', 'Initials': 'L', 'LastName': 'Valdez', 'Affiliation': 'Department of Neurology, Columbia University Medical Center, New York, New York.'}, {'ForeName': 'Luisa', 'Initials': 'L', 'LastName': 'Gomez Chan', 'Affiliation': 'Department of Neurology, Columbia University Medical Center, New York, New York.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Kong', 'Affiliation': 'Research Division, Hebrew Home at Riverdale, Bronx, New York.'}, {'ForeName': 'Mildred', 'Initials': 'M', 'LastName': 'Ramirez', 'Affiliation': 'Research Division, Hebrew Home at Riverdale, Bronx, New York.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Ravenell', 'Affiliation': 'Department of Population Health, NYU School of Medicine, New York, New York.'}, {'ForeName': 'Gbenga', 'Initials': 'G', 'LastName': 'Ogedegbe', 'Affiliation': 'Department of Population Health, NYU School of Medicine, New York, New York.'}, {'ForeName': 'James M', 'Initials': 'JM', 'LastName': 'Noble', 'Affiliation': 'Department of Neurology, Columbia University Medical Center, New York, New York.'}]",JAMA neurology,['10.1001/jamaneurol.2019.1741'] 954,31801155,"Meningitis, urinary tract, and bloodstream infections in very low birth weight infants enrolled in a heart rate characteristics monitoring trial.","BACKGROUND Displaying heart rate characteristic (HRC) scores was associated with lower sepsis-associated mortality in very low birth weight (VLBW) infants in a multicenter randomized controlled trial (HeRO trial). The aim of this study was to test whether HRC indices rise before diagnosis of urinary tract infection (UTI) or meningitis, with and without concomitant BSI. METHODS Blood, urine, and cerebrospinal fluid (CSF) culture data after 3 days of age and within 120 days of study enrollment were analyzed from 2989 VLBW infants. The HRC index was analyzed 12 h prior to positive cultures compared to 36 h prior, using paired signed-rank tests. RESULTS UTI, meningitis, and BSI were diagnosed in 10%, 2%, and 24% of infants, respectively. The mean hourly HRC index was significantly higher 12 h prior to diagnosis of UTI and BSI compared to 36 h prior (UTI 2.07 versus 1.81; BSI 2.62 versus 2.25, both p < 0.0001). The baseline HRC index was higher for meningitis, compared to UTI or BSI, but without a statistically significant rise in the day prior to meningitis diagnosis. CONCLUSIONS In a large cohort of VLBW infants enrolled in the HeRO trial, the HRC index increased in the 24-h period prior to diagnosis of UTI and BSI but not meningitis.",2020,"The baseline HRC index was higher for meningitis, compared to UTI or BSI, but without a statistically significant rise in the day prior to meningitis diagnosis. ","['Blood, urine, and cerebrospinal fluid (CSF) culture data after 3 days of age and within 120 days of study enrollment were analyzed from 2989 VLBW infants', 'very low birth weight infants enrolled in a heart rate characteristic monitoring trial']",[],"['HRC index', 'baseline HRC index', 'Meningitis, urinary tract, and bloodstream infections', 'mean hourly HRC index', 'UTI, meningitis, and BSI']","[{'cui': 'C0005768'}, {'cui': 'C0042037'}, {'cui': 'C0430403', 'cui_str': 'Cerebrospinal fluid culture (procedure)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0282667', 'cui_str': 'Infant, Very Low Birth Weight'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}]",[],"[{'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0025289', 'cui_str': 'Meningitis'}, {'cui': 'C0042027'}, {'cui': 'C2316160', 'cui_str': 'Infection of bloodstream'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0558292', 'cui_str': 'Hourly (qualifier value)'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease (disorder)'}]",,0.151055,"The baseline HRC index was higher for meningitis, compared to UTI or BSI, but without a statistically significant rise in the day prior to meningitis diagnosis. ","[{'ForeName': 'Joern-Hendrik', 'Initials': 'JH', 'LastName': 'Weitkamp', 'Affiliation': 'Vanderbilt University Medical Center, Nashville, TN, USA. hendrik.weitkamp@vumc.org.'}, {'ForeName': 'Judy L', 'Initials': 'JL', 'LastName': 'Aschner', 'Affiliation': 'Pediatrics, Hackensack Meridian Health School of Medicine, Nutley, NJ, USA.'}, {'ForeName': 'Wallly A', 'Initials': 'WA', 'LastName': 'Carlo', 'Affiliation': 'University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Bancalari', 'Affiliation': 'University of Miami, Miami, FL, USA.'}, {'ForeName': 'Jose A', 'Initials': 'JA', 'LastName': 'Perez', 'Affiliation': 'Pediatrix Medical Group, Orlando, FL, USA.'}, {'ForeName': 'Cristina T', 'Initials': 'CT', 'LastName': 'Navarrete', 'Affiliation': 'University of Miami, Miami, FL, USA.'}, {'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Schelonka', 'Affiliation': 'Oregon Health Science University, Portland, OR, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Whit Walker', 'Affiliation': 'USC School of Medicine, Greenville Memorial Hospital, Greenville, SC, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Porcelli', 'Affiliation': 'Pediatrics, Wake Forest University, Winston-Salem, NC, USA.'}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': ""O'Shea"", 'Affiliation': 'Pediatrics, University of North Carolina School of Medicine, Chapel Hill, NC, USA.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Palmer', 'Affiliation': 'Pediatrics, Pennsylvania State University, Hershey, PA, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Grossarth', 'Affiliation': 'Vanderbilt University Medical Center, Nashville, TN, USA.'}, {'ForeName': 'Douglas E', 'Initials': 'DE', 'LastName': 'Lake', 'Affiliation': 'University of Virginia, Charlottesville, VA, USA.'}, {'ForeName': 'Karen D', 'Initials': 'KD', 'LastName': 'Fairchild', 'Affiliation': 'University of Virginia, Charlottesville, VA, USA.'}]",Pediatric research,['10.1038/s41390-019-0701-4'] 955,31796225,A study to evaluate the immunogenicity and shedding of live attenuated influenza vaccine strains in children 24-<48 months of age.,"BACKGROUND Quadrivalent live attenuated influenza vaccine (LAIV4) showed reduced effectiveness against the A/H1N1 component in the 2013-2014 and 2015-2016 influenza seasons. The most likely cause of reduced LAIV effectiveness against A(H1N1)pdm09 strains was poor intranasal replication. OBJECTIVES To compare the immunogenicity and shedding of a new A/H1N1 strain (A/Slovenia), to a A/H1N1 strain known to have reduced effectiveness (A/Bolivia). PATIENTS/METHODS This was a randomized, double-blind, multicenter study. Children aged 24-<48 months of age were randomized 1:1:1 to receive two doses of LAIV4 2017-2018 (LAIV4 A/Slovenia ), or LAIV4 2015-2016 or trivalent LAIV (LAIV3) 2015-2016 formulations (LAIV4 A/Bolivia or LAIV3 A/Bolivia , respectively) on days 1 and 28. The primary endpoint was strain-specific hemagglutination inhibition (HAI) antibody seroresponse at 28 days post each dose, and secondary endpoints included immunogenicity, shedding, and safety. Solicited symptoms, adverse events (AEs), and serious AEs (SAEs) were recorded. Pre-specified statistical testing was limited to the primary endpoint of HAI antibody responses. RESULTS A total of 200 children were randomized (median age 35.3 months; 53% male; 57% had previously received influenza vaccine). Significantly higher HAI antibody responses for the A/Slovenia strain were observed after Dose 1 and Dose 2. Neutralizing antibodies and nasal immunoglobulin A antibody responses were higher for A/Slovenia versus A/Bolivia. More children shed the A/Slovenia vaccine strain than the A/Bolivia strain on Days 4-7 after Dose 1. No deaths, SAEs, or discontinuations from vaccine occurred. CONCLUSIONS The new A(H1N1)pdm09 A/Slovenia LAIV strain demonstrated improved immunogenicity compared with a previous strain with reduced effectiveness and induced immune responses comparable to a highly efficacious pre-pandemic H1N1 LAIV strain. These results support the use of LAIV4 containing A/Slovenia as a vaccine option in clinical practice.",2020,The new A(H1N1)pdm09 A/Slovenia LAIV strain demonstrated improved immunogenicity compared with a previous strain with reduced effectiveness and induced immune responses comparable to a highly efficacious pre-pandemic H1N1 LAIV strain.,"['200 children were randomized (median age 35.3\xa0months; 53% male; 57% had previously received', 'Children aged 24-<48\xa0months of age', 'children 24-<48\xa0months of age']","['influenza vaccine (LAIV4', 'live attenuated influenza vaccine strains', 'H1N1 strain (A/Slovenia', 'influenza vaccine', 'LAIV4 2017-2018 (LAIV4 A/Slovenia ), or LAIV4 2015-2016 or trivalent LAIV (LAIV3) 2015-2016 formulations (LAIV4 A/Bolivia or LAIV3 A/Bolivia , respectively) on days 1 and 28']","['Solicited symptoms, adverse events (AEs), and serious AEs (SAEs', 'Neutralizing antibodies and nasal immunoglobulin A antibody responses', 'No deaths, SAEs, or discontinuations', 'HAI antibody responses', 'HAI) antibody seroresponse', 'strain-specific hemagglutination inhibition', 'immunogenicity, shedding, and safety']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}]","[{'cui': 'C0021403', 'cui_str': 'Influenza Vaccines'}, {'cui': 'C3652556', 'cui_str': 'influenza, live attenuated'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0080194', 'cui_str': 'Strains'}, {'cui': 'C0580264', 'cui_str': 'H1N1'}, {'cui': 'C0037334', 'cui_str': 'Slovenia'}, {'cui': 'C0005918', 'cui_str': 'Bolivia'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1142254', 'cui_str': 'Neutralising antibodies'}, {'cui': 'C4520890', 'cui_str': 'Nasal'}, {'cui': 'C1292068', 'cui_str': 'Antibody, immunoglobulin A class (substance)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0003261', 'cui_str': 'Antibody Response'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C0080194', 'cui_str': 'Strains'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0018904', 'cui_str': 'Hemagglutination Inhibition Tests'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",200.0,0.358124,The new A(H1N1)pdm09 A/Slovenia LAIV strain demonstrated improved immunogenicity compared with a previous strain with reduced effectiveness and induced immune responses comparable to a highly efficacious pre-pandemic H1N1 LAIV strain.,"[{'ForeName': 'Raburn M', 'Initials': 'RM', 'LastName': 'Mallory', 'Affiliation': 'MedImmune, Gaithersburg, MD, USA. Electronic address: malloryr@MedImmune.com.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Nyborg', 'Affiliation': 'MedImmune, Gaithersburg, MD, USA.'}, {'ForeName': 'Rubana N', 'Initials': 'RN', 'LastName': 'Kalyani', 'Affiliation': 'MedImmune, Gaithersburg, MD, USA.'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Yuan', 'Affiliation': 'MedImmune, Gaithersburg, MD, USA.'}, {'ForeName': 'Stan L', 'Initials': 'SL', 'LastName': 'Block', 'Affiliation': 'Kentucky Pediatrics and Adult Research Inc., Bardstown, KY, USA.'}, {'ForeName': 'Filip', 'Initials': 'F', 'LastName': 'Dubovsky', 'Affiliation': 'MedImmune, Gaithersburg, MD, USA.'}]",Vaccine,['10.1016/j.vaccine.2019.11.055'] 956,31239304,Effects of flow rate on transnasal pulmonary aerosol delivery of bronchodilators via high-flow nasal cannula for patients with COPD and asthma: protocol for a randomised controlled trial.,"INTRODUCTION Both in vitro and in vivo radiolabelled studies on nebulisation via high-flow nasal cannula showed that inhaled dose decreases as the administered gas flow increases. In our previous in vitro study, we investigated the effects of the ratio of gas flow to subject's peak inspiratory flow (GF:IF) on the aerosol deposition, which increased as the GF:IF decreased, with an optimal GF:IF between 0.1 and 0.5 producing a stable 'lung' deposition in both quiet and distressed breathing. Thus, we aim to validate our in vitro findings in subjects with reversible airflow limitations by assessing their response to inhaled bronchodilator. METHODS AND ANALYSIS This is a single-centre, randomised controlled trial. Subjects with chronic obstructive pulmonary disease or asthma with positive response to 400μg albuterol via metered dose inhaler and valved holding chamber will be enrolled and consented. After a washout period (1-3 days), subjects will be randomly assigned to inhale albuterol with one of three gas flows: 50 L/min, GF:IF=1.0 and GF:IF=0.5. In each arm, subjects will inhale 2 mL saline, followed by escalating doubling doses (0.5, 1, 2 and 4 mg) of albuterol in a fill volume of 2 mL, delivered by a vibrating mesh nebuliser via heated nasal cannula set up at 37°C. An interval of 30 min between each dose of albuterol, with spirometry measured at baseline and after each inhalation. Titration will be terminated if forced expiratory volume in 1 s improvement is <5%, or adverse event is observed. ETHICS AND DISSEMINATION This trial has been approved by the Ethic Committee of People's Liberation Army General Hospital, Beijing, China (no. S2018-200-01). The results will be disseminated through peer-reviewed journals, national and international conferences. TRIAL REGISTRATION NUMBER NCT03739359; Pre-results.",2019,"Titration will be terminated if forced expiratory volume in 1 s improvement is <5%, or adverse event is observed. ","['Subjects with chronic obstructive pulmonary disease or asthma with positive response to 400μg albuterol via metered dose inhaler and valved holding chamber will be enrolled and consented', 'subjects with reversible airflow limitations', 'patients with COPD and asthma']","['bronchodilators via high-flow nasal cannula', 'albuterol']",[],"[{'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0001927', 'cui_str': 'Albuterol'}, {'cui': 'C0475209', 'cui_str': 'm'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0021461', 'cui_str': 'Inhalators'}, {'cui': 'C2350030', 'cui_str': 'Valved Holding Chambers'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0205343', 'cui_str': 'Reversible (qualifier value)'}, {'cui': 'C0231999', 'cui_str': 'Airflow, function (observable entity)'}, {'cui': 'C0449295', 'cui_str': 'Limitation (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0006280', 'cui_str': 'Bronchodilators'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0179574', 'cui_str': 'Nasal Cannula'}, {'cui': 'C0001927', 'cui_str': 'Albuterol'}]",[],,0.250586,"Titration will be terminated if forced expiratory volume in 1 s improvement is <5%, or adverse event is observed. ","[{'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Cardiopulmonary Sciences, Division of Respiratory Care, Rush University, Chicago, Illinois, USA.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Luo', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Sichuan University West China Hospital, Chengdu, China.'}, {'ForeName': 'Yibing', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': ""Department of Respiratory and Critical Care Medicine, Pulmonary Function Test Lab, General Hospital of People's Liberation Army, Beijing, China.""}, {'ForeName': 'Lixing', 'Initials': 'L', 'LastName': 'Xie', 'Affiliation': ""Department of Respiratory and Critical Care Medicine, Pulmonary Function Test Lab, General Hospital of People's Liberation Army, Beijing, China.""}, {'ForeName': 'James B', 'Initials': 'JB', 'LastName': 'Fink', 'Affiliation': 'Department of Cardiopulmonary Sciences, Division of Respiratory Care, Rush University, Chicago, Illinois, USA.'}]",BMJ open,['10.1136/bmjopen-2018-028584'] 957,31208393,"Comparison of 0.05% cyclosporine and 3% diquafosol solution for dry eye patients: a randomized, blinded, multicenter clinical trial.","BACKGROUND This study is aim to compare the clinical effectiveness between the two most prominent dry eye disease (DED)-specific eye drops, 0.05% cyclosporine (CN) and 3% diquafosol (DQ). METHODS This is a multi-centered, randomized, masked, prospective clinical study. A total of 153 DED patients were randomly allocated to use CN twice per day or DQ six times daily. Cornea and conjunctival staining scores (NEI scale), tear break-up time (TBUT), Schirmer test scores, and ocular surface disease index (OSDI) score were measured at baseline, 4 and 12 weeks after treatment. RESULTS At 12 weeks after treatment, NEI scaled scores were significantly reduced from the baseline by - 6.60 for CN and - 6.63 for DQ group (all P < 0.0001, P = 0.9739 between groups). TBUT and Schirmer values for CN were significantly improved from the baseline at 4 and 12 weeks (P = 0.0034, P < 0.0001 for TBUT, P = 0.0418, P = 0.0031 for Schirmer test). However, for DQ, TBUT showed significant improvement at 12 weeks only (P = 0.0281). Mean OSDI score differences from the baseline to 12 weeks were improved by - 13.03 ± 19.63 for CN and - 16.11 ± 20.87 for DQ, respectively (all P < 0.0001, P = 0.854 between groups). Regarding drug compliance, the mean instillation frequency of CN was less than that of DQ (P < 0.001). There were no statistically significant intergroup differences in safety evaluation. CONCLUSIONS The level of improvement regarding NEI, TBUT, and OSDI scores were not significantly different between the two treatment groups. However, with regards to the early improvement of TBUT and patient compliance, patients using CN improved faster and with greater adherence to drug usage than did those treated with DQ. TRIAL REGISTRATION KCT0002180 , retrospectively registered on 23 December 2016.",2019,"The level of improvement regarding NEI, TBUT, and OSDI scores were not significantly different between the two treatment groups.","['retrospectively registered on 23 December 2016', 'A total of 153 DED patients', 'dry eye patients']","['cyclosporine (CN) and 3% diquafosol (DQ', 'CN', 'cyclosporine and 3% diquafosol solution']","['Cornea and conjunctival staining scores (NEI scale), tear break-up time (TBUT), Schirmer test scores, and ocular surface disease index (OSDI) score', 'safety evaluation', 'level of improvement regarding NEI, TBUT, and OSDI scores', 'mean instillation frequency of CN', 'NEI scaled scores', 'TBUT and Schirmer values for CN', 'Mean OSDI score differences']","[{'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0314719', 'cui_str': 'Dry eyes (finding)'}]","[{'cui': 'C0010594', 'cui_str': 'Cyclosporins'}, {'cui': 'C1955479', 'cui_str': ""diuridine 5'-(pentahydrogen tetraphosphate) tetrasodium salt""}, {'cui': 'C0037633', 'cui_str': 'Solutions'}]","[{'cui': 'C0010031', 'cui_str': 'Cornea'}, {'cui': 'C0487602', 'cui_str': 'Staining'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1955969', 'cui_str': 'NEI (US)'}, {'cui': 'C0222045'}, {'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0200152', 'cui_str': ""Schirmer's test (procedure)""}, {'cui': 'C1557335', 'cui_str': 'Ocular surface disease'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0184959', 'cui_str': 'Instillation - action (qualifier value)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",153.0,0.221216,"The level of improvement regarding NEI, TBUT, and OSDI scores were not significantly different between the two treatment groups.","[{'ForeName': 'Chang Hyun', 'Initials': 'CH', 'LastName': 'Park', 'Affiliation': ""Department of Ophthalmology, Yeouido St. Mary's Hospital, College of Medicine, The Catholic University of Korea, 10, 63-ro, Yeongdeungpo-gu, Seoul, 07345, Republic of Korea.""}, {'ForeName': 'Hyung Keun', 'Initials': 'HK', 'LastName': 'Lee', 'Affiliation': 'The Institute of Vision Research, Department of Ophthalmology, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Mee Kum', 'Initials': 'MK', 'LastName': 'Kim', 'Affiliation': 'Department of Ophthalmology, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Eun Chul', 'Initials': 'EC', 'LastName': 'Kim', 'Affiliation': ""Department of Ophthalmology, Bucheon St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Bucheon, Republic of Korea.""}, {'ForeName': 'Jae Yong', 'Initials': 'JY', 'LastName': 'Kim', 'Affiliation': 'Department of Ophthalmology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Tae-Im', 'Initials': 'TI', 'LastName': 'Kim', 'Affiliation': 'The Institute of Vision Research, Department of Ophthalmology, Severance Hospital, Yonsei University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Hong Kyun', 'Initials': 'HK', 'LastName': 'Kim', 'Affiliation': 'Department of Ophthalmology, Kyungpook National University School of Medicine, Daegu, Republic of Korea.'}, {'ForeName': 'Jong Suk', 'Initials': 'JS', 'LastName': 'Song', 'Affiliation': 'Department of Ophthalmology, Korea University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Kyung Chul', 'Initials': 'KC', 'LastName': 'Yoon', 'Affiliation': 'Department of Ophthalmology, Chonnam National University Medical School, Gwangju, Republic of Korea.'}, {'ForeName': 'Do Hyung', 'Initials': 'DH', 'LastName': 'Lee', 'Affiliation': 'Department of Ophthalmology, Ilsan Paik Hospital, Inje University College of Medicine, Goyang, Republic of Korea.'}, {'ForeName': 'Tae-Young', 'Initials': 'TY', 'LastName': 'Chung', 'Affiliation': 'Department of Ophthalmology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Chul Young', 'Initials': 'CY', 'LastName': 'Choi', 'Affiliation': 'Department of Ophthalmology, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Hyun Seung', 'Initials': 'HS', 'LastName': 'Kim', 'Affiliation': ""Department of Ophthalmology, Yeouido St. Mary's Hospital, College of Medicine, The Catholic University of Korea, 10, 63-ro, Yeongdeungpo-gu, Seoul, 07345, Republic of Korea. sara514@catholic.ac.kr.""}]",BMC ophthalmology,['10.1186/s12886-019-1136-8'] 958,31794324,"Valproate and Retinoic Acid in Combination With Decitabine in Elderly Nonfit Patients With Acute Myeloid Leukemia: Results of a Multicenter, Randomized, 2 × 2, Phase II Trial.","PURPOSE DNA-hypomethylating agents are studied in combination with other epigenetic drugs, such as histone deacetylase inhibitors or differentiation inducers (eg, retinoids), in myeloid neoplasias. A randomized, phase II trial with a 2 × 2 factorial design was conducted to investigate the effects of the histone deacetylase inhibitor valproate and all- trans retinoic acid (ATRA) in treatment-naive elderly patients with acute myeloid leukemia (AML). PATIENTS AND METHODS Two hundred patients (median age, 76 years; range, 61-92 years) ineligible for induction chemotherapy received decitabine (20 mg/m 2 intravenously, days 1 to 5) alone (n = 47) or in combination with valproate (n = 57), ATRA (n = 46), or valproate + ATRA (n = 50). The primary endpoint was objective response, defined as complete and partial remission, tested at a one-sided significance level of α = .10. Key secondary endpoints were overall survival, event-free survival, and progression-free survival and safety. RESULTS The addition of ATRA resulted in a higher remission rate (21.9% with ATRA v 13.5% without ATRA; odds ratio, 1.80; 95% CI, 0.86 to 3.79; one-sided P = .06). For valproate, no effect was observed (17.8% with valproate v 17.2% without valproate; odds ratio, 1.06; 95% CI, 0.51 to 2.21; one-sided P = .44). Median overall survival was 8.2 months with ATRA v 5.1 months without ATRA (hazard ratio, 0.65; 95% CI, 0.48 to 0.89; two-sided P = .006). Improved survival was observed across risk groups, including patients with adverse cytogenetics, and was associated with longer response duration. With valproate, no survival difference was observed. Toxicities were predominantly hematologic, without relevant differences between the 4 arms. CONCLUSION The addition of ATRA to decitabine resulted in a higher remission rate and a clinically meaningful survival extension in these patients with difficult-to-treat disease, without added toxicity.",2020,"The addition of ATRA resulted in a higher remission rate (21.9% with ATRA v 13.5% without ATRA; odds ratio, 1.80; 95% CI, 0.86 to 3.79; one-sided P = .06).","['Elderly Nonfit Patients With Acute Myeloid Leukemia', 'treatment-naive elderly patients with acute myeloid leukemia (AML', 'Two hundred patients (median age, 76 years; range, 61-92 years) ineligible for']","['valproate + ATRA', 'ATRA', 'Valproate and Retinoic Acid', 'Decitabine', 'induction chemotherapy received decitabine (20 mg/m 2 intravenously, days 1 to 5) alone (n = 47) or in combination with valproate', 'valproate', 'histone deacetylase inhibitor valproate and all- trans retinoic acid (ATRA']","['objective response, defined as complete and partial remission, tested at a one-sided significance level of α ', 'Toxicities', 'remission rate', 'Median overall survival', 'Improved survival', 'survival difference', 'overall survival, event-free survival, and progression-free survival and safety']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0023467', 'cui_str': 'Nonlymphoblastic Leukemia, Acute'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}]","[{'cui': 'C0080356', 'cui_str': 'Valproate'}, {'cui': 'C0040845', 'cui_str': 'retinoic acid'}, {'cui': 'C0049065', 'cui_str': 'decitabine'}, {'cui': 'C3179010', 'cui_str': 'Induction Chemotherapy'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C1512474', 'cui_str': 'HDAC Inhibitors'}]","[{'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",200.0,0.406788,"The addition of ATRA resulted in a higher remission rate (21.9% with ATRA v 13.5% without ATRA; odds ratio, 1.80; 95% CI, 0.86 to 3.79; one-sided P = .06).","[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Lübbert', 'Affiliation': 'Faculty of Medicine and Medical Center, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Grishina', 'Affiliation': 'Faculty of Medicine and Medical Center, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Schmoor', 'Affiliation': 'Faculty of Medicine and Medical Center, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Richard F', 'Initials': 'RF', 'LastName': 'Schlenk', 'Affiliation': 'University Hospital of Ulm, Ulm, Germany.'}, {'ForeName': 'Edgar', 'Initials': 'E', 'LastName': 'Jost', 'Affiliation': 'University Hospital Rheinisch-Westfälische Technische Hochschule Aachen University, Aachen, Germany.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Crysandt', 'Affiliation': 'University Hospital Rheinisch-Westfälische Technische Hochschule Aachen University, Aachen, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Heuser', 'Affiliation': 'Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Felicitas', 'Initials': 'F', 'LastName': 'Thol', 'Affiliation': 'Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Helmut R', 'Initials': 'HR', 'LastName': 'Salih', 'Affiliation': 'German Cancer Consortium (DKTK) and German Cancer Research Center (DKFZ), Tübingen, Germany.'}, {'ForeName': 'Marcus M', 'Initials': 'MM', 'LastName': 'Schittenhelm', 'Affiliation': 'Eberhard-Karls-University, Tübingen, Germany.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Germing', 'Affiliation': 'Faculty of Medicine, Heinrich-Heine University, Düsseldorf, Germany.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Kuendgen', 'Affiliation': 'Faculty of Medicine, Heinrich-Heine University, Düsseldorf, Germany.'}, {'ForeName': 'Katharina S', 'Initials': 'KS', 'LastName': 'Götze', 'Affiliation': 'Technical University of Munich, Munich, Germany.'}, {'ForeName': 'Hans-Walter', 'Initials': 'HW', 'LastName': 'Lindemann', 'Affiliation': 'Catholic Hospital, Hagen, Germany.'}, {'ForeName': 'Carsten', 'Initials': 'C', 'LastName': 'Müller-Tidow', 'Affiliation': 'Heidelberg University Hospital, Heidelberg, Germany.'}, {'ForeName': 'Gerhard', 'Initials': 'G', 'LastName': 'Heil', 'Affiliation': 'Klinikum Lüdenscheid, Lüdenscheid, Germany.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Scholl', 'Affiliation': 'Universitätsklinikum Jena, Jena, Germany.'}, {'ForeName': 'Gesine', 'Initials': 'G', 'LastName': 'Bug', 'Affiliation': 'University Hospital Frankfurt, Goethe University, Frankfurt, Germany.'}, {'ForeName': 'Carsten', 'Initials': 'C', 'LastName': 'Schwaenen', 'Affiliation': 'Hospital Esslingen, Esslingen, Germany.'}, {'ForeName': 'Aristoteles', 'Initials': 'A', 'LastName': 'Giagounidis', 'Affiliation': 'Marien-Hospital Düsseldorf, Düsseldorf, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Neubauer', 'Affiliation': 'University Clinic Gießen/Marburg, Marburg, Germany.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Krauter', 'Affiliation': 'Städtisches Klinikum Braunschweig, Braunschweig, Germany.'}, {'ForeName': 'Wolfram', 'Initials': 'W', 'LastName': 'Brugger', 'Affiliation': 'Hospital Villingen-Schwenningen, Villingen-Schwenningen, Germany.'}, {'ForeName': 'Maike', 'Initials': 'M', 'LastName': 'De Wit', 'Affiliation': 'Vivantes Klinikum Neukoelln, Berlin, Germany.'}, {'ForeName': 'Ralph', 'Initials': 'R', 'LastName': 'Wäsch', 'Affiliation': 'Faculty of Medicine and Medical Center, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Heiko', 'Initials': 'H', 'LastName': 'Becker', 'Affiliation': 'Faculty of Medicine and Medical Center, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Annette M', 'Initials': 'AM', 'LastName': 'May', 'Affiliation': 'Faculty of Medicine and Medical Center, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Justus', 'Initials': 'J', 'LastName': 'Duyster', 'Affiliation': 'Faculty of Medicine and Medical Center, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Konstanze', 'Initials': 'K', 'LastName': 'Döhner', 'Affiliation': 'University Hospital of Ulm, Ulm, Germany.'}, {'ForeName': 'Arnold', 'Initials': 'A', 'LastName': 'Ganser', 'Affiliation': 'Hannover Medical School, Hannover, Germany.'}, {'ForeName': 'Björn', 'Initials': 'B', 'LastName': 'Hackanson', 'Affiliation': 'Faculty of Medicine and Medical Center, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Hartmut', 'Initials': 'H', 'LastName': 'Döhner', 'Affiliation': 'University Hospital of Ulm, Ulm, Germany.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.01053'] 959,31783900,"Structured, proactive care coordination versus usual care for Improving Morbidity during Post-Acute Care Transitions for Sepsis (IMPACTS): a pragmatic, randomized controlled trial.","BACKGROUND Hospital mortality for patients with sepsis has recently declined, but sepsis survivors still suffer from significant long-term mortality and morbidity. There are limited data that support effective strategies to address post-discharge management of patients hospitalized with sepsis. METHODS The Improving Morbidity during Post-Acute Care Transitions for Sepsis (IMPACTS) study is a pragmatic, randomized controlled trial at three hospitals within a single healthcare delivery system comparing clinical outcomes between sepsis survivors who receive usual care versus care delivered through the Sepsis Transition and Recovery (STAR) program. The STAR program includes a centrally located nurse navigator using telephone counseling and electronic health record-based support to facilitate best-practice post-sepsis care strategies for patients during hospitalization and the 30 days after hospital discharge, including post-discharge review of medications, evaluation for new impairments or symptoms, monitoring existing comorbidities, and palliative care referral when appropriate. Adults admitted through the Emergency Department with suspected infection (i.e., antibiotics initiated, bacterial cultures drawn) and deemed, by previously developed risk-stratification models, high risk for readmission or death are included. Eligible patients are randomly allocated 1:1 to either Arm 1, usual care or Arm 2, STAR. Planned enrollment is 708 patients during a 6-month period. The primary outcome is the composite of all-cause hospital readmissions and mortality assessed 30 days post discharge. Secondary outcomes include 30- and 90-day hospital readmissions, mortality, emergency department visits, acute care-free days alive, and acute care and total costs. DISCUSSION This pragmatic evaluation provides the most comprehensive assessment to date of a strategy to improve delivery of recommended post-sepsis care. TRIAL REGISTRATION ClinicalTrials.gov, NCT03865602. Registered retrospectively on 6 March 2019.",2019,"Secondary outcomes include 30- and 90-day hospital readmissions, mortality, emergency department visits, acute care-free days alive, and acute care and total costs. ","['patients with sepsis', 'patients hospitalized with sepsis', '708 patients during a 6-month period', 'Eligible patients', 'Adults admitted through the Emergency Department with suspected infection (i.e., antibiotics initiated, bacterial cultures drawn) and deemed, by previously developed risk-stratification models, high risk for readmission or death are included']","['proactive care coordination versus usual care', 'usual care versus care delivered through the Sepsis Transition and Recovery (STAR) program', 'telephone counseling and electronic health record-based support to facilitate best-practice post-sepsis care strategies', 'usual care or Arm 2, STAR']","['30- and 90-day hospital readmissions, mortality, emergency department visits, acute care-free days alive, and acute care and total costs', 'composite of all-cause hospital readmissions and mortality assessed 30\u2009days post discharge', 'Morbidity']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0243026', 'cui_str': 'Sepsis'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0750491', 'cui_str': 'Suspected (qualifier value)'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C0430402', 'cui_str': 'Bacterial culture (procedure)'}, {'cui': 'C0013113', 'cui_str': 'Drawing'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C0242414', 'cui_str': 'Coordination (observable entity)'}, {'cui': 'C0243026', 'cui_str': 'Sepsis'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C2362543', 'cui_str': 'Electronic Medical Record'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C3179154', 'cui_str': 'Best Practices'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}]","[{'cui': 'C0587438', 'cui_str': 'Day hospital (environment)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C2584946', 'cui_str': 'Alive'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0600290', 'cui_str': 'Hospital Readmissions'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}]",708.0,0.228654,"Secondary outcomes include 30- and 90-day hospital readmissions, mortality, emergency department visits, acute care-free days alive, and acute care and total costs. ","[{'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Kowalkowski', 'Affiliation': 'Center for Outcomes Research and Evaluation, Atrium Health, 1540 Garden Terrace, Suite 308, Charlotte, NC, 28203, USA. Marc.Kowalkowski@AtriumHealth.org.'}, {'ForeName': 'Shih-Hsiung', 'Initials': 'SH', 'LastName': 'Chou', 'Affiliation': 'Center for Outcomes Research and Evaluation, Atrium Health, 1540 Garden Terrace, Suite 308, Charlotte, NC, 28203, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'McWilliams', 'Affiliation': 'Center for Outcomes Research and Evaluation, Atrium Health, 1540 Garden Terrace, Suite 308, Charlotte, NC, 28203, USA.'}, {'ForeName': 'Cathryn', 'Initials': 'C', 'LastName': 'Lashley', 'Affiliation': 'Ambulatory Care Management, Atrium Health, Charlotte, NC, USA.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Murphy', 'Affiliation': 'Transition Services, Department of Internal Medicine, Atrium Health, Charlotte, NC, USA.'}, {'ForeName': 'Whitney', 'Initials': 'W', 'LastName': 'Rossman', 'Affiliation': 'Center for Outcomes Research and Evaluation, Atrium Health, 1540 Garden Terrace, Suite 308, Charlotte, NC, 28203, USA.'}, {'ForeName': 'Alfred', 'Initials': 'A', 'LastName': 'Papali', 'Affiliation': 'Division of Critical Care, Department of Internal Medicine, Atrium Health, Charlotte, NC, USA.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Heffner', 'Affiliation': 'Department of Emergency Medicine, Atrium Health, Charlotte, NC, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Russo', 'Affiliation': 'Division of Hepatology, Department of Internal Medicine, Atrium Health, Charlotte, NC, USA.'}, {'ForeName': 'Larry', 'Initials': 'L', 'LastName': 'Burke', 'Affiliation': 'Division of Palliative Care, Department of Internal Medicine, Atrium Health, Charlotte, NC, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Gibbs', 'Affiliation': 'Department of Emergency Medicine, Atrium Health, Charlotte, NC, USA.'}, {'ForeName': 'Stephanie P', 'Initials': 'SP', 'LastName': 'Taylor', 'Affiliation': 'Department of Internal Medicine, Atrium Health, Charlotte, NC, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Trials,['10.1186/s13063-019-3792-7'] 960,31796533,Can we extend the indication for sentinel node biopsy in vulvar cancer? A nationwide feasibility study from Sweden.,"BACKGROUND In squamous cell vulvar cancer, sentinel node biopsy is accepted as standard treatment in well-defined patient groups and has reduced surgical morbidity considerably. Currently, due to the lack of evidence, it cannot be offered to patients with tumors of 4 cm diameter or greater or with multifocal tumors, or in local recurrences. PRIMARY OBJECTIVE This study is primarily a pilot and feasibility trial, aiming to evaluate if the prerequisites concerning detection rate and negative predictive value are satisfactory before the implementation of a multinational trial. STUDY HYPOTHESIS Sentinel node biopsy has an acceptable negative predictive value and detection rate in the study cohort. TRIAL DESIGN This study is planned as a prospective, national, multicenter interventional trial. Participating patients will undergo a sentinel node biopsy in addition to an inguinofemoral lymphadenectomy. INCLUSION AND EXCLUSION CRITERIA Inclusion criteria: for women in group 1, a primary tumor ≥4 cm in diameter; in group 2, a multifocal primary tumor; in group 3, a local recurrence without previous inguinofemoral lymphadenectomy or radiation to the groins; in group 4, a local recurrence, with previous inguinofemoral lymphadenectomy and/or radiation to the groins. PRIMARY ENDPOINT The primary endpoints are the detection rate and the negative predictive value of the sentinel node procedure. SAMPLE SIZE In each of the four study arms, recruitment of 20-30 patients is planned. ESTIMATED DATES FOR COMPLETING RECRUITMENT AND PRESENTING RESULTS: Recruitment will take place between November 2019 and October 2021. Results will be available in December 2021. TRIAL REGISTRATION The trial is registered at ""ClinicalTrials.gov"" (ID: NCT04147780).",2020,"Currently, due to the lack of evidence, it cannot be offered to patients with tumors of 4 cm diameter or greater or with multifocal tumors, or in local recurrences. ","['Inclusion criteria: for women in group 1, a primary tumor ≥4\u2009cm in diameter; in group 2, a multifocal primary tumor; in group 3, a local recurrence without previous inguinofemoral lymphadenectomy or radiation to the groins; in group 4, a local recurrence, with previous inguinofemoral lymphadenectomy and/or radiation to the groins', 'patients with tumors of 4\u2009cm diameter or greater or with multifocal tumors']",[],['detection rate and the negative predictive value of the sentinel node procedure'],"[{'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0441861', 'cui_str': 'Group 1 (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C1301886', 'cui_str': 'Diameter (qualifier value)'}, {'cui': 'C0441865', 'cui_str': 'Group 2 (qualifier value)'}, {'cui': 'C0205292', 'cui_str': 'Multifocal (qualifier value)'}, {'cui': 'C0441869', 'cui_str': 'Group 3 (qualifier value)'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0398408', 'cui_str': 'Inguinofemoral lymphadenectomy (procedure)'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C0018246', 'cui_str': 'Groin'}, {'cui': 'C0441876', 'cui_str': 'Group 4 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C1302461', 'cui_str': 'Multifocal tumor'}]",[],"[{'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0677944', 'cui_str': 'Signal node (disorder)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}]",,0.0933713,"Currently, due to the lack of evidence, it cannot be offered to patients with tumors of 4 cm diameter or greater or with multifocal tumors, or in local recurrences. ","[{'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Zach', 'Affiliation': 'Division for Obstetrics and Gynecology, Karolinska University Hospital, Stockholm, Sweden diana.zach@sll.se.'}, {'ForeName': 'Paivi', 'Initials': 'P', 'LastName': 'Kannisto', 'Affiliation': 'Obstetrics and Gynecology, Clinical Sciences, Lund, Sweden.'}, {'ForeName': 'Katja', 'Initials': 'K', 'LastName': 'Stenström Bohlin', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Gothenburg Sahlgrenska Academy, Goteborg, Sweden.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Moberg', 'Affiliation': 'Obstetrics and Gynecology, Clinical Sciences, Lund, Sweden.'}, {'ForeName': 'Preben', 'Initials': 'P', 'LastName': 'Kjölhede', 'Affiliation': 'Obstetrics and Gynecology, Linkopings Universitet Institutionen for klinisk och experimentell medicin, Linkoping, Sweden.'}]",International journal of gynecological cancer : official journal of the International Gynecological Cancer Society,['10.1136/ijgc-2019-000938'] 961,31678833,"Acute and residual effects of smoked cannabis: Impact on driving speed and lateral control, heart rate, and self-reported drug effects.","BACKGROUND Although driving under the influence of cannabis is increasingly common among young adults, little is known about residual effects on driver behavior. This study examined acute and residual effects of smoked cannabis on simulated driving performance of young cannabis users. METHODS In this double-blind, placebo-controlled, parallel-group randomized clinical trial, cannabis users (1-4 days/week) aged 19-25 years were randomized with a 2:1 allocation ratio to receive active (12.5% THC) or placebo (0.009% THC) cannabis in a single 750 mg cigarette. A median split (based on whole-blood THC concentrations at the time of driving) was used to divide the active group into low and high THC groups. Our primary outcome was simulated driving performance, assessed 30 min and 24 and 48 h after smoking. Secondary outcomes included blood THC concentrations, subjective drug effects, and heart rate. RESULTS Ninety-six participants were randomized, and 91 were included in the final analysis (30 high THC, 31 low THC, 30 placebo). Mean speed (but not lateral control) significantly differed between groups 30 min after smoking cannabis (p ≤ 0.02); low and high THC groups decreased their speed compared to placebo. Heart rate, VAS drug effect and drug high increased significantly immediately after smoking cannabis and declined steadily after that. There was little evidence of residual effects in any of the measures. CONCLUSION Acutely, cannabis caused decreased speed, increased heart rate, and increases in VAS drug effect and drug high. There was no evidence of residual effects on these measures over the two days following cannabis administration.",2019,Mean speed (but not lateral control) significantly differed between groups 30 min after smoking cannabis (p ≤ 0.02); low and high THC groups decreased their speed compared to placebo.,"['smoked cannabis', 'Ninety-six participants were randomized, and 91 were included in the final analysis (30 high THC, 31 low THC, 30 placebo', 'young adults', 'young cannabis users', 'cannabis users (1-4 days/week) aged 19-25 years']","['placebo', 'smoked cannabis', 'placebo (0.009% THC) cannabis in a single 750\u202fmg cigarette']","['Mean speed', 'simulated driving performance', 'driving speed and lateral control, heart rate, and self-reported drug effects', 'VAS drug effect', 'Heart rate, VAS drug effect and drug high increased significantly immediately after smoking cannabis', 'heart rate', 'blood THC concentrations, subjective drug effects, and heart rate']","[{'cui': 'C0678449', 'cui_str': 'Cannabis'}, {'cui': 'C4319625', 'cui_str': '96'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0039663', 'cui_str': 'dronabinol'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0677547', 'cui_str': 'days/week (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0678449', 'cui_str': 'Cannabis'}, {'cui': 'C0039663', 'cui_str': 'dronabinol'}, {'cui': 'C0936079', 'cui_str': 'Hemp Plant'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C4517868', 'cui_str': '750 (qualifier value)'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0004379', 'cui_str': 'Drivings, Automobile'}, {'cui': 'C0205093', 'cui_str': 'Lateral (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0728867', 'cui_str': 'Drug action (finding)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0678449', 'cui_str': 'Cannabis'}, {'cui': 'C0005768'}, {'cui': 'C0039663', 'cui_str': 'dronabinol'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}]",96.0,0.409585,Mean speed (but not lateral control) significantly differed between groups 30 min after smoking cannabis (p ≤ 0.02); low and high THC groups decreased their speed compared to placebo.,"[{'ForeName': 'Bruna', 'Initials': 'B', 'LastName': 'Brands', 'Affiliation': ""Controlled Substances Directorate, Health Canada, Ottawa, Ontario, Canada; Department of Pharmacology and Toxicology, University of Toronto, 27 King's College Circle, Toronto, Ontario, M5S3H7, Canada; Institute for Mental Health Policy Research, Centre for Addiction and Mental Health, 33 Russell Street, Toronto, Ontario, M5S2S1, Canada. Electronic address: Bruna.Brands@canada.ca.""}, {'ForeName': 'Robert E', 'Initials': 'RE', 'LastName': 'Mann', 'Affiliation': 'Institute for Mental Health Policy Research, Centre for Addiction and Mental Health, 33 Russell Street, Toronto, Ontario, M5S2S1, Canada; Dalla Lana School of Public Health, University of Toronto, 155 College Street, Toronto, Ontario, M5T3M7, Canada.'}, {'ForeName': 'Christine M', 'Initials': 'CM', 'LastName': 'Wickens', 'Affiliation': 'Institute for Mental Health Policy Research, Centre for Addiction and Mental Health, 33 Russell Street, Toronto, Ontario, M5S2S1, Canada; Dalla Lana School of Public Health, University of Toronto, 155 College Street, Toronto, Ontario, M5T3M7, Canada.'}, {'ForeName': 'Beth', 'Initials': 'B', 'LastName': 'Sproule', 'Affiliation': 'Leslie Dan Faculty of Pharmacy, University of Toronto, 144 College Street, Toronto, Ontario, M5S3M2, Canada; Department of Psychiatry, University of Toronto, 250 College Street, Toronto, Ontario, M5T1R8, Canada; Pharmacy, Centre for Addiction and Mental Health, 1001 Queen Street, Toronto, Ontario, M6J1H4, Canada.'}, {'ForeName': 'Gina', 'Initials': 'G', 'LastName': 'Stoduto', 'Affiliation': 'Institute for Mental Health Policy Research, Centre for Addiction and Mental Health, 33 Russell Street, Toronto, Ontario, M5S2S1, Canada.'}, {'ForeName': 'Gillian S', 'Initials': 'GS', 'LastName': 'Sayer', 'Affiliation': ""Department of Pharmacology and Toxicology, University of Toronto, 27 King's College Circle, Toronto, Ontario, M5S3H7, Canada; Institute for Mental Health Policy Research, Centre for Addiction and Mental Health, 33 Russell Street, Toronto, Ontario, M5S2S1, Canada.""}, {'ForeName': 'Jillian', 'Initials': 'J', 'LastName': 'Burston', 'Affiliation': ""Department of Pharmacology and Toxicology, University of Toronto, 27 King's College Circle, Toronto, Ontario, M5S3H7, Canada; Institute for Mental Health Policy Research, Centre for Addiction and Mental Health, 33 Russell Street, Toronto, Ontario, M5S2S1, Canada.""}, {'ForeName': 'Jie Fei', 'Initials': 'JF', 'LastName': 'Pan', 'Affiliation': ""Department of Pharmacology and Toxicology, University of Toronto, 27 King's College Circle, Toronto, Ontario, M5S3H7, Canada; Institute for Mental Health Policy Research, Centre for Addiction and Mental Health, 33 Russell Street, Toronto, Ontario, M5S2S1, Canada.""}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Matheson', 'Affiliation': ""Department of Pharmacology and Toxicology, University of Toronto, 27 King's College Circle, Toronto, Ontario, M5S3H7, Canada; Institute for Mental Health Policy Research, Centre for Addiction and Mental Health, 33 Russell Street, Toronto, Ontario, M5S2S1, Canada.""}, {'ForeName': 'Cristiana', 'Initials': 'C', 'LastName': 'Stefan', 'Affiliation': 'Clinical Laboratory and Diagnostic Services, Centre for Addiction and Mental Health, 100 Stokes Street, Toronto, Ontario, M6J1H4, Canada.'}, {'ForeName': 'Tony P', 'Initials': 'TP', 'LastName': 'George', 'Affiliation': 'Department of Psychiatry, University of Toronto, 250 College Street, Toronto, Ontario, M5T1R8, Canada; Addictions Division, Centre for Addiction and Mental Health, 100 Stokes Street, Toronto, Ontario, M6J1H4, Canada.'}, {'ForeName': 'Marilyn A', 'Initials': 'MA', 'LastName': 'Huestis', 'Affiliation': 'The Lambert Center for the Study of Medicinal Cannabis and Hemp, Thomas Jefferson University, 1020 Walnut Street Philadelphia, PA 19107, United States.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Rehm', 'Affiliation': 'Institute for Mental Health Policy Research, Centre for Addiction and Mental Health, 33 Russell Street, Toronto, Ontario, M5S2S1, Canada; Dalla Lana School of Public Health, University of Toronto, 155 College Street, Toronto, Ontario, M5T3M7, Canada; Department of Psychiatry, University of Toronto, 250 College Street, Toronto, Ontario, M5T1R8, Canada.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Le Foll', 'Affiliation': ""Department of Pharmacology and Toxicology, University of Toronto, 27 King's College Circle, Toronto, Ontario, M5S3H7, Canada; Department of Psychiatry, University of Toronto, 250 College Street, Toronto, Ontario, M5T1R8, Canada; Translational Addiction Research Laboratory, Centre for Addiction and Mental Health, 33 Russell Street, Toronto, Ontario, M5S2S1, Canada; Department of Family and Community Medicine, University of Toronto, 500 University Avenue, 5th Floor, Toronto, Ontario, M5G 1V7, Canada; Institute of Medical Sciences, University of Toronto, 1 King's College Circle, Room 2374, Toronto, Ontario, M5S 1A8, Canada.""}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2019.107641'] 962,31797385,Effects of a scalable home-visiting intervention on child development in slums of urban India: evidence from a randomised controlled trial.,"BACKGROUND An estimated 63.4 million Indian children under 5 years are at risk of poor development. Home visits that use a structured curriculum to help caregivers enhance the quality of the home stimulation environment improve developmental outcomes. However, achieving effectiveness in poor urban contexts through scalable models remains challenging. METHODS Using a cluster randomised controlled trial, we evaluated a psychosocial stimulation intervention, comprising weekly home visits for 18 months, in urban slums of Cuttack, Odisha, India. The intervention is complementary to existing early childhood services in India and was run and managed through a local branch of a national NGO. The study ran from August 2013 to July 2015. We enrolled 421 children aged 10-20 months from 54 slums. Slums were randomised to intervention or control. Primary outcomes were children's cognitive, receptive language, expressive language and fine motor development assessed using the Bayley-III. Prespecified intent-to-treat analysis investigated impacts and heterogeneity by gender. TRIAL REGISTRATIONS ISRCTN89476603, AEARCTR-0000169. RESULTS Endline data for 378 (89.8%) children were analysed. Attrition was balanced between groups. We found improvements of 0.349 of a standard deviation (SD; p = .005, stepdown p = .017) to cognition while impacts on receptive language, expressive language and fine motor development were, respectively, 0.224 SD (p = .099, stepdown p = .184), 0.192 SD (p = .085, stepdown p = .184) and 0.111 (p = .385, stepdown p = .385). A child development factor improved by 0.301 SD (p = .032). Benefits were larger for boys. The quality of the home stimulation environment also improved. CONCLUSIONS This study shows that a potentially scalable home-visiting intervention is effective in poor urban areas.",2020,"We found improvements of 0.349 of a standard deviation (SD; p = .005, stepdown","['421 children aged 10-20\xa0months from 54 slums', '18\xa0months, in urban slums of Cuttack, Odisha, India', '63.4 million Indian children under 5\xa0years', 'child development in slums of urban India', 'The study ran from August 2013 to July 2015']","['psychosocial stimulation intervention', 'scalable home-visiting intervention', 'stepdown']","['receptive language, expressive language and fine motor development', ""children's cognitive, receptive language, expressive language and fine motor development assessed using the Bayley-III""]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0037345', 'cui_str': 'Slums'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0021201', 'cui_str': 'Republic of India'}, {'cui': 'C1524069', 'cui_str': 'Indian (racial group)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0008071', 'cui_str': 'Child Development'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0600140', 'cui_str': 'Does run (finding)'}]","[{'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0020043', 'cui_str': 'Home Visits'}]","[{'cui': 'C0023008', 'cui_str': 'Languages'}, {'cui': 'C0205232', 'cui_str': 'Fine (qualifier value)'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439070', 'cui_str': 'III'}]",421.0,0.130971,"We found improvements of 0.349 of a standard deviation (SD; p = .005, stepdown","[{'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Andrew', 'Affiliation': 'Institute for Fiscal Studies, London, UK.'}, {'ForeName': 'Orazio', 'Initials': 'O', 'LastName': 'Attanasio', 'Affiliation': 'Institute for Fiscal Studies, London, UK.'}, {'ForeName': 'Britta', 'Initials': 'B', 'LastName': 'Augsburg', 'Affiliation': 'Institute for Fiscal Studies, London, UK.'}, {'ForeName': 'Monimalika', 'Initials': 'M', 'LastName': 'Day', 'Affiliation': 'Center for Early Childhood Education and Development, Ambedkar University, Delhi, India.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Grantham-McGregor', 'Affiliation': 'UCL Great Ormond Street Institute of Child Health, London, UK.'}, {'ForeName': 'Costas', 'Initials': 'C', 'LastName': 'Meghir', 'Affiliation': 'Institute for Fiscal Studies, London, UK.'}, {'ForeName': 'Fardina', 'Initials': 'F', 'LastName': 'Mehrin', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Dhaka, Bangladesh.'}, {'ForeName': 'Smriti', 'Initials': 'S', 'LastName': 'Pahwa', 'Affiliation': 'Pratham, Delhi, India.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Rubio-Codina', 'Affiliation': 'Inter-American Development Bank, Washington, DC, USA.'}]","Journal of child psychology and psychiatry, and allied disciplines",['10.1111/jcpp.13171'] 963,31775780,EMG-based vibro-tactile biofeedback training: effective learning accelerator for children and adolescents with dystonia? A pilot crossover trial.,"BACKGROUND This study is aimed at better understanding the role of a wearable and silent ElectroMyoGraphy-based biofeedback on motor learning in children and adolescents with primary and secondary dystonia. METHODS A crossover study with a wash-out period of at least 1 week was designed; the device provides the patient with a vibration proportional to the activation of an impaired target muscle. The protocol consisted of two 5-day blocks during which subjects were trained and tested on a figure-8 writing task: their performances (at different levels of difficulty) were evaluated in terms of both kinematics and muscular activations on day 1 and day 5, while the other 3 days were purely used as training sessions. The training was performed with and without using the biofeedback device: the week of use was randomized. Data were collected on 14 subjects with primary and secondary (acquired) dystonia (age: 6-19 years). RESULTS Results comparing kinematic-based and EMG-based outcome measures pre- and post-training showed learning due to practice for both subjects with primary and secondary dystonia. On top of said learning, an improvement in terms of inter-joint coordination and muscular pattern functionality was recorded only for secondary dystonia subjects, when trained with the aid of the EMG-based biofeedback device. CONCLUSIONS Our results support the hypothesis that children and adolescents with primary dystonia in which there is intact sensory processing do not benefit from feedback augmentation, whereas children with secondary dystonia, in which sensory deficits are often present, exhibit a higher learning capacity when augmented movement-related sensory information is provided. This study represents a fundamental investigation to address the scarcity of noninvasive therapeutic interventions for young subjects with dystonia.",2019,"On top of said learning, an improvement in terms of inter-joint coordination and muscular pattern functionality was recorded only for secondary dystonia subjects, when trained with the aid of the EMG-based biofeedback device. ","['14 subjects with primary and secondary (acquired) dystonia (age: 6-19\u2009years', 'children and adolescents with dystonia', 'children and adolescents with primary dystonia', 'children and adolescents with primary and secondary dystonia', 'young subjects with dystonia']","['EMG-based vibro-tactile biofeedback training', 'ElectroMyoGraphy-based biofeedback']",['inter-joint coordination and muscular pattern functionality'],"[{'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0752205', 'cui_str': 'Dystonia, Secondary'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0013421', 'cui_str': 'Muscle Dystonia'}, {'cui': 'C0752203', 'cui_str': 'Dystonia, Primary'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}]","[{'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0439815', 'cui_str': 'Tactile (qualifier value)'}, {'cui': 'C0678663', 'cui_str': 'Biofeedback, function (observable entity)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0022417', 'cui_str': 'Joints'}, {'cui': 'C0242414', 'cui_str': 'Coordination (observable entity)'}, {'cui': 'C0442025', 'cui_str': 'Muscular (qualifier value)'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}]",,0.0348299,"On top of said learning, an improvement in terms of inter-joint coordination and muscular pattern functionality was recorded only for secondary dystonia subjects, when trained with the aid of the EMG-based biofeedback device. ","[{'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Casellato', 'Affiliation': 'NearLab, Department of Electronics, Information and Bioengineering, Politecnico di Milano, Milan, Italy. claudia.casellato@unipv.it.'}, {'ForeName': 'Emilia', 'Initials': 'E', 'LastName': 'Ambrosini', 'Affiliation': 'NearLab, Department of Electronics, Information and Bioengineering, Politecnico di Milano, Milan, Italy. emilia.ambrosini@polimi.it.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Galbiati', 'Affiliation': 'NearLab, Department of Electronics, Information and Bioengineering, Politecnico di Milano, Milan, Italy.'}, {'ForeName': 'Emilia', 'Initials': 'E', 'LastName': 'Biffi', 'Affiliation': 'Scientific Institute, IRCCS E. Medea, Lecco, Bosisio Parini, Italy.'}, {'ForeName': 'Ambra', 'Initials': 'A', 'LastName': 'Cesareo', 'Affiliation': 'Scientific Institute, IRCCS E. Medea, Lecco, Bosisio Parini, Italy.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Beretta', 'Affiliation': 'Scientific Institute, IRCCS E. Medea, Lecco, Bosisio Parini, Italy.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Lunardini', 'Affiliation': 'NearLab, Department of Electronics, Information and Bioengineering, Politecnico di Milano, Milan, Italy.'}, {'ForeName': 'Giovanna', 'Initials': 'G', 'LastName': 'Zorzi', 'Affiliation': 'Department of Child Neurology, Foundation IRCCS Neurological Institute Carlo Besta, Milan, Italy.'}, {'ForeName': 'Terence D', 'Initials': 'TD', 'LastName': 'Sanger', 'Affiliation': 'Department of Biomedical Engineering, University of Southern California, Los Angeles, USA.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Pedrocchi', 'Affiliation': 'NearLab, Department of Electronics, Information and Bioengineering, Politecnico di Milano, Milan, Italy.'}]",Journal of neuroengineering and rehabilitation,['10.1186/s12984-019-0620-y'] 964,31517745,Coagulation System Disorders and Thrombosis Prophylaxis During Laparoscopic Fundoplications.,"BACKGROUND The aim of this study was to assess and recommend the optimal deep vein thrombosis (DVT) prophylaxis regimen during and after laparoscopic fundoplication according to the blood coagulation disorders and the rate of DVT in 2 patient groups, receiving different DVT prophylaxis regimens. MATERIALS AND METHODS This was a prospective randomized, single-center clinical study. The study population, 121 patients, were divided into 2 groups: group I received low-molecular-weight heparin 12 hours before the operation; group II received low-molecular-weight heparin only 1 hour before the laparoscopic fundoplication. Both groups received intermittent pneumatic compression during the entire procedure. Bilateral Doppler ultrasound to exclude DVT was performed before the surgery. Venous phase computed tomographic images were acquired from the ankle to the iliac tubercles on the third postoperative day to determine the presence and location of DVT. Hypercoagulation state was assessed by measuring the prothrombin fragment F1+2 (F1+2), the thrombin-antithrombin complex (TAT), and tissue factor microparticles activity (MP-TF) in plasma. The hypocoagulation effect was evaluated by measuring plasma free tissue factor pathway inhibitor (fTFPI). RESULTS F1+2, TAT, and MP-TF indexes increased significantly, whereas fTFPI levels decreased significantly during and after laparoscopic fundoplication, when molecular-weight heparin was administered 12 hours before the operation. Computed tomography venography revealed peroneal vein thrombosis in 2 group I patients on the third postoperative day. Total postsurgical DVT frequency was 1.65%: 3.6% in group I, with no DVT in group II. CONCLUSION Molecular-weight heparin and intraoperative intermittent pneumatic compression controls the hypercoagulation effect more efficiently when it is administered 1 hour before surgery: it causes significant reduction of F1+2, TAT, and MP-TF indexes and significant increases of fTFPI levels during and after laparoscopic fundoplication.",2019,"RESULTS F1+2, TAT, and MP-TF indexes increased significantly, whereas fTFPI levels decreased significantly during and after laparoscopic fundoplication, when molecular-weight heparin was administered 12 hours before the operation.","['121 patients', '2 patient groups, receiving different DVT prophylaxis regimens']","['low-molecular-weight heparin 12 hours before the operation; group II received low-molecular-weight heparin only 1 hour before the laparoscopic fundoplication', 'Thrombosis Prophylaxis', 'Bilateral Doppler ultrasound to exclude DVT', 'intermittent pneumatic compression', 'no DVT', 'Computed tomography venography']","['Total postsurgical DVT frequency', 'plasma free tissue factor pathway inhibitor (fTFPI', 'F1+2, TAT, and MP-TF indexes', 'Hypercoagulation state', 'thrombin-antithrombin complex (TAT), and tissue factor microparticles activity (MP-TF) in plasma', 'fTFPI levels', 'peroneal vein thrombosis']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0853245', 'cui_str': 'DVT prophylaxis'}]","[{'cui': 'C0019139', 'cui_str': 'LMWH'}, {'cui': 'C1292430', 'cui_str': '12 hours'}, {'cui': 'C0038895', 'cui_str': 'operative therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}, {'cui': 'C0521257', 'cui_str': 'Laparoscopic fundoplication (procedure)'}, {'cui': 'C0199242', 'cui_str': 'Anticoagulant prophylaxis (procedure)'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0162481', 'cui_str': 'Doppler Ultrasound'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0149871', 'cui_str': 'Deep Vein Thrombosis'}, {'cui': 'C0205267', 'cui_str': 'Intermittent (qualifier value)'}, {'cui': 'C0332459', 'cui_str': 'Compression (morphologic abnormality)'}, {'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}, {'cui': 'C0031545', 'cui_str': 'Venography'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0149871', 'cui_str': 'Deep Vein Thrombosis'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0164707', 'cui_str': 'TFPI'}, {'cui': 'C0052128', 'cui_str': 'AT III-protease complex'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0398623', 'cui_str': 'Hypercoagulability'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0040048', 'cui_str': 'Prothrombinase'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0226836', 'cui_str': 'Structure of peroneal vein'}, {'cui': 'C0040053', 'cui_str': 'Thrombosis'}]",121.0,0.0214807,"RESULTS F1+2, TAT, and MP-TF indexes increased significantly, whereas fTFPI levels decreased significantly during and after laparoscopic fundoplication, when molecular-weight heparin was administered 12 hours before the operation.","[{'ForeName': 'Indre', 'Initials': 'I', 'LastName': 'Zostautiene', 'Affiliation': 'Departments of Radiology.'}, {'ForeName': 'Erika', 'Initials': 'E', 'LastName': 'Skrodeniene', 'Affiliation': 'Laboratory Medicine.'}, {'ForeName': 'Astra', 'Initials': 'A', 'LastName': 'Vitkauskiene', 'Affiliation': 'Laboratory Medicine.'}, {'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Zviniene', 'Affiliation': 'Departments of Radiology.'}, {'ForeName': 'Antanas', 'Initials': 'A', 'LastName': 'Mickevicius', 'Affiliation': 'Surgery.'}, {'ForeName': 'Rolandas', 'Initials': 'R', 'LastName': 'Gerbutavicius', 'Affiliation': 'Oncology and Haematology.'}, {'ForeName': 'Rima', 'Initials': 'R', 'LastName': 'Gerbutaviciene', 'Affiliation': 'Drug Technology and Social Pharmacy, Lithuanian University of Health Sciences, Kaunas, Lithuania.'}, {'ForeName': 'Mindaugas', 'Initials': 'M', 'LastName': 'Kiudelis', 'Affiliation': 'Surgery.'}]","Surgical laparoscopy, endoscopy & percutaneous techniques",['10.1097/SLE.0000000000000709'] 965,31775999,The Treatment of Proximal Humerus Fracture Using Internal Fixation with Fixed-angle Plates.,"BACKGROUND Implants made of various types of material can be used for the internal fixation of fractures. Carbon fiber reinforced polyetheretherketone (CFR-PEEK) is a radiolucent material that may have advantageous handling properties compared with titanium implants. METHODS Seventy-six patients with proximal humerus fractures requiring surgery were randomized to receive a fixed-angle plate made out of either titanium or CFR- PEEK. To measure the functional outcome, the DASH score (Disabilities of Arm, Shoulder, and Hand; primary endpoint), the Simple Shoulder Test (SST), and the Oxford Shoulder Score (OSS) were determined in 63 patients at 6 weeks, 12 weeks, and 6 months after surgery, accompanied at each time point by radiological evaluation. RESULTS Both groups displayed improvement in DASH scores 6 months after surgery (CFR-PEEK: 27.5 ± 20.5; titanium: 28.5 ± 17.9; p = 0.82). Sensitivity analysis with multiple imputations confirmed this result (27.4 ± 19.2 versus 28.5 ± 16.6). The OSS and SST scores were likewise improved in both groups. All patients displayed full bony consolidation 12 weeks after surgery. In no case was material failure, secondary dislocation, or screw perforation seen. No difference was seen in the maintenance of postoperative reposition between the CFR-PEEK group and the titanium group. CONCLUSION The internal fixation of proximal humerus fractures with either CFR-PEEK or titanium led to clinical improvement 6 months after surgery. No clinical or radiological difference in outcomes was seen between the two groups. Because of the study design, however, the equivalence of the two interventions was not con- clusively demonstrated; a non-inferiority study would have been needed for this purpose.",2019,"No difference was seen in the maintenance of postoperative reposition between the CFR-PEEK group and the titanium group. ",['Seventy-six patients with proximal humerus fractures requiring surgery'],"['Carbon fiber reinforced polyetheretherketone (CFR-PEEK', 'titanium or CFR- PEEK', 'CFR-PEEK or titanium', 'Proximal Humerus Fracture Using Internal Fixation with Fixed-angle Plates']","['OSS and SST scores', 'DASH scores', 'postoperative reposition', 'functional outcome, the DASH score (Disabilities of Arm, Shoulder, and Hand; primary endpoint), the Simple Shoulder Test (SST), and the Oxford Shoulder Score (OSS', 'material failure, secondary dislocation, or screw perforation seen']","[{'cui': 'C4319622', 'cui_str': 'Seventy-six'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205107', 'cui_str': 'Proximal (qualifier value)'}, {'cui': 'C0020162', 'cui_str': 'Humeral Fractures'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0108411', 'cui_str': 'Carbon Felt'}, {'cui': 'C0084113', 'cui_str': 'polyetheretherketone'}, {'cui': 'C1305363', 'cui_str': 'Catalytic fraction'}, {'cui': 'C0040302', 'cui_str': 'Titanium'}, {'cui': 'C0205107', 'cui_str': 'Proximal (qualifier value)'}, {'cui': 'C0020162', 'cui_str': 'Humeral Fractures'}, {'cui': 'C0016642', 'cui_str': 'Osteosynthesis, Fracture'}, {'cui': 'C0443218', 'cui_str': 'Fixed (qualifier value)'}, {'cui': 'C0205143', 'cui_str': 'Angular (qualifier value)'}, {'cui': 'C0407295', 'cui_str': 'Fixation of fracture using plate (procedure)'}]","[{'cui': 'C0449206', 'cui_str': 'OSS (body structure)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0556030', 'cui_str': 'Repositioning (procedure)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C1997924', 'cui_str': 'Disability of arm'}, {'cui': 'C0037004', 'cui_str': 'Shoulder'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0205352', 'cui_str': 'Simple (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C2960740', 'cui_str': 'Oxford shoulder score'}, {'cui': 'C0520510', 'cui_str': 'Material (attribute)'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0012691', 'cui_str': 'Joint Dislocations'}, {'cui': 'C0301559', 'cui_str': 'Screw (physical object)'}, {'cui': 'C0549099', 'cui_str': 'Perforation (morphologic abnormality)'}]",76.0,0.0553761,"No difference was seen in the maintenance of postoperative reposition between the CFR-PEEK group and the titanium group. ","[{'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Ziegler', 'Affiliation': 'BG Hospital Tübingen, University Clinic for Trauma and Reconstructive Surgery, University of Tübingen, Germany; Center for Musculoskeletal Surgery, Charité University Medical Center Berlin, Germany; Center for Bone and Joint Surgery, Kronprinzenbau Hospital, Reutlingen, Germany; BG Hospital Murnau, Murnau, Germany.'}, {'ForeName': 'Sven', 'Initials': 'S', 'LastName': 'Maier', 'Affiliation': ''}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Stöckle', 'Affiliation': ''}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Gühring', 'Affiliation': ''}, {'ForeName': 'Fabian M', 'Initials': 'FM', 'LastName': 'Stuby', 'Affiliation': ''}]",Deutsches Arzteblatt international,['10.3238/arztebl.2019.0757'] 966,31230494,Magnesium Bioavailability and Tolerability Do Not Differ between Two Supplements with Different Release Properties.,"Magnesium (Mg 2+ ) is one of the most frequently supplemented micronutrients. Due to possible gastrointestinal side effects, the European Food Safety Authority and the Institute of Medicine set the upper intake level for Mg 2+ from supplements to 250 and 350 mg, respectively. Nevertheless, systematic data concerning the tolerability of Mg 2+ supplements are scarce. The aim of the study was to directly compare the bioavailability and tolerability of two 500 mg Mg 2+ supplements in a crossover study with duplicate determination. The different release properties were either a direct release (one phase) or a delayed release of the second half (two phases). An open-label, controlled trial with a crossover design, duplicate determination, and one-week washout phases was conducted. The participants ingested the test product after overnight fasting. Blood samples were taken at baseline and after 1, 2, 3, 4, 6, and 8 hours, and urine was collected over a period of 24 hours. The participants were on standardized nutrition during all examination days. There were no significant differences between the test products regarding 24-hour renal Mg 2+ excretion and area under the curve of serum Mg 2+ levels for 8 hours. Both test products were well tolerated with a very low frequency of gastrointestinal adverse effects and no significant differences between the test products. The Mg 2+ bioavailability did not differ between the test products. The supplements examined had the same good tolerability. Both test products are therefore suited to enhance Mg 2+ supply without relevant side effects.",2020,Both test products were well tolerated with a very low frequency of gastrointestinal adverse effects and no significant differences between the test products.,[],"['two 500\u2009mg Mg 2+ supplements', 'Magnesium (Mg 2+ ']","['bioavailability and tolerability', 'Magnesium Bioavailability and Tolerability', '24-hour renal Mg 2+ excretion and area under the curve of serum Mg 2+ levels']",[],"[{'cui': 'C3816747', 'cui_str': 'Five hundred'}, {'cui': 'C3540792', 'cui_str': 'Magnesium supplements, alimentary tract and metabolism'}]","[{'cui': 'C0005508', 'cui_str': 'Bioavailability'}, {'cui': 'C3540792', 'cui_str': 'Magnesium supplements, alimentary tract and metabolism'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C0221102', 'cui_str': 'Excretory function (observable entity)'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",,0.0300089,Both test products were well tolerated with a very low frequency of gastrointestinal adverse effects and no significant differences between the test products.,"[{'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Greupner', 'Affiliation': 'Institute of Food Science and Human Nutrition, Leibniz University Hannover, Hannover, Germany.'}, {'ForeName': 'Inga', 'Initials': 'I', 'LastName': 'Schneider', 'Affiliation': 'Institute of Food Science and Human Nutrition, Leibniz University Hannover, Hannover, Germany.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Gellert', 'Affiliation': 'Institute of Food Science and Human Nutrition, Leibniz University Hannover, Hannover, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Hahn', 'Affiliation': 'Institute of Food Science and Human Nutrition, Leibniz University Hannover, Hannover, Germany.'}]",Journal of dietary supplements,['10.1080/19390211.2019.1629146'] 967,31203649,Effects of Brief Behavioral Treatment for Insomnia on Daily Associations between Self-Reported Sleep and Objective Cognitive Performance in Older Adults.,"OBJECTIVE Behavioral treatments for insomnia improve sleep in older adults, but research documenting their effects on cognitive performance is mixed. We explored whether a brief behavioral treatment for insomnia (BBTi) impacts daily associations between sleep parameters and next day cognition. METHODS Sixty-two older adults ( M age   = 69.45 years, SD  = 7.71) with insomnia completed either 4 weeks of BBTi or self-monitoring control (SMC). At baseline, post-treatment, and 3 month follow-up, participants completed 14 days of diaries measuring sleep onset latency (SOL), wake after sleep onset (WASO), total sleep time (TST), and sleep efficiency (SE), as well as daily cognitive tests measuring processing speed (i.e., symbol digit modalities test, SDMT), and reasoning (i.e., letter series). At each time period, associations between sleep parameters and daily cognition, controlling for age, education, insomnia duration, use of sleep medications, and depression (i.e., Beck Depression Inventory-2 nd Edition scores), were examined through multilevel modeling. RESULTS At post-treatment, we observed an interactive fixed effect of treatment condition (i.e., BBTi/SMC) and TST on daily SDMT and letter series performance. For BBTi, longer TST was associated with better letter series performance, and did not predict SDMT performance. For SMC, longer TST was associated with worse SDMT, and was not associated with letter series performance. Greater WASO (regardless of group) was associated with better SDMT performance at post-treatment. Associations were not maintained at follow-up. CONCLUSIONS Sleep duration may play an important role in BBTi-related improvements in daily higher order cognition. Maintenance of these associations may be facilitated by booster sessions following post-treatment. CLINICAL TRIAL IDENTIFIER NCT02967185.",2020,Greater WASO (regardless of group) was associated with better SDMT performance at post-treatment.,"['Sixty-two older adults ( M age \xa0 ', '69.45\xa0years, SD\xa0 =\xa07.71) with insomnia completed either 4\xa0weeks of BBTi or self-monitoring control (SMC', 'Older Adults', 'older adults']",['Brief Behavioral Treatment'],"['diaries measuring sleep onset latency (SOL), wake after sleep onset (WASO), total sleep time (TST), and sleep efficiency (SE), as well as daily cognitive tests measuring processing speed (i.e., symbol digit modalities test, SDMT), and reasoning (i.e., letter series', 'Greater WASO', 'SDMT performance', 'sleep parameters and daily cognition, controlling for age, education, insomnia duration, use of sleep medications, and depression (i.e., Beck Depression Inventory-2 nd Edition scores']","[{'cui': 'C4517835', 'cui_str': '62 (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517861', 'cui_str': '7.71'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0181904', 'cui_str': 'Monitor, device (physical object)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0376660', 'cui_str': 'Diary'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C4505222', 'cui_str': 'REM Sleep Latency'}, {'cui': 'C0442696', 'cui_str': 'Waking (observable entity)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0582591', 'cui_str': 'Processing speed (observable entity)'}, {'cui': 'C0451522', 'cui_str': 'Symbol Digit Modalities Test'}, {'cui': 'C1096774', 'cui_str': 'Letter'}, {'cui': 'C0205549', 'cui_str': 'Series (qualifier value)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory (assessment scale)'}, {'cui': 'C0441792', 'cui_str': 'Editions (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",62.0,0.0251172,Greater WASO (regardless of group) was associated with better SDMT performance at post-treatment.,"[{'ForeName': 'Christina S', 'Initials': 'CS', 'LastName': 'McCrae', 'Affiliation': 'Department of Psychiatry, University of Missouri-Columbia , Columbia, MO.'}, {'ForeName': 'Ashley F', 'Initials': 'AF', 'LastName': 'Curtis', 'Affiliation': 'Department of Psychiatry, University of Missouri-Columbia , Columbia, MO.'}, {'ForeName': 'Jacob M', 'Initials': 'JM', 'LastName': 'Williams', 'Affiliation': 'TIRR Memorial Hermann , Houston, TX.'}, {'ForeName': 'Natalie D', 'Initials': 'ND', 'LastName': 'Dautovich', 'Affiliation': 'Psychology Department, Virginia Commonwealth University , Richmond, VA.'}, {'ForeName': 'Joseph P H', 'Initials': 'JPH', 'LastName': 'McNamara', 'Affiliation': 'Department of Psychiatry, University of Florida , Gainesville, FL.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Stripling', 'Affiliation': 'College of Psychology, Nova Southeastern University , Fort Lauderdale, Florida.'}, {'ForeName': 'Joseph M', 'Initials': 'JM', 'LastName': 'Dzierzewski', 'Affiliation': 'Psychology Department, Virginia Commonwealth University , Richmond, VA.'}, {'ForeName': 'Richard B', 'Initials': 'RB', 'LastName': 'Berry', 'Affiliation': 'College of Medicine, University of Florida , Gainesville, FL.'}, {'ForeName': 'Karin M', 'Initials': 'KM', 'LastName': 'McCoy', 'Affiliation': 'Neuropsychology Service, South Texas Veterans Health Care System , San Antonio, TX.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Marsiske', 'Affiliation': 'Department of Clinical and Health Psychology, University of Florida , Gainesville, FL.'}]",Behavioral sleep medicine,['10.1080/15402002.2019.1632201'] 968,30975478,"Posterior Hip Precautions Do Not Impact Early Recovery in Total Hip Arthroplasty: A Multicenter, Randomized, Controlled Study.","BACKGROUND Posterior hip precautions have been routinely prescribed to decrease dislocation rates. The purpose of this study was to determine whether the absence of hip precautions improved early recovery after total hip arthroplasty via the posterolateral approach. METHODS Patients undergoing total hip arthroplasty via the posterolateral approach at 3 centers were enrolled. Patients meeting the selection criteria were randomized to standard hip precautions (SHP) or no hip precautions (NHP) for 6 weeks following surgery. HOOS Jr, Health State visual analog score, and rate of pain scores were recorded preoperatively and in subsequent postoperative visits; dislocation episodes were also noted. Standard statistical analysis was performed. RESULTS From 2016 to 2017, 159 patients were randomized to SHP and 154 patients were randomized to NHP. Controlling for the center at which the surgery was performed, the only difference in outcome scores between the 2 groups was at 2 weeks; the NHP group had a lower HOOS Jr score when compared to the SHP group (P = .03). There was no difference in outcome scores at any other time points when compared to preoperative assessments. In the SHP group, there were 2 recorded dislocations (1.3%) and 1 in the NHP group (0.7%; P = .62). CONCLUSION In this multicenter, randomized, controlled study, the absence of hip precautions in the postoperative period did not improve subjective outcomes which may be explained by the self-limiting behavior of NHP patients. Furthermore, with the numbers available for the study, there was no difference in the rate of dislocation between the 2 groups.",2019,There was no difference in outcome scores at any other time points when compared to preoperative assessments.,"['Patients meeting the selection criteria', 'Total Hip Arthroplasty', 'Patients undergoing total hip arthroplasty via the posterolateral approach at 3 centers were enrolled', 'From 2016 to 2017, 159 patients were randomized to SHP and 154 patients']","['NHP', 'standard hip precautions (SHP) or no hip precautions (NHP']","['HOOS Jr score', 'dislocation rates', 'rate of dislocation', 'HOOS Jr, Health State visual analog score, and rate of pain scores']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0242801', 'cui_str': 'Selection Criteria'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0186193', 'cui_str': 'Arthroplasty of coxofemoral joint'}, {'cui': 'C0587271', 'cui_str': 'Posterolateral approach (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0012691', 'cui_str': 'Joint Dislocations'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}]",159.0,0.0786813,There was no difference in outcome scores at any other time points when compared to preoperative assessments.,"[{'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Dietz', 'Affiliation': 'Department of Orthopaedics, Health Sciences Center, WVU School of Medicine, Morgantown, WV.'}, {'ForeName': 'Adam E', 'Initials': 'AE', 'LastName': 'Klein', 'Affiliation': 'Department of Orthopaedics, Health Sciences Center, WVU School of Medicine, Morgantown, WV.'}, {'ForeName': 'Brock A', 'Initials': 'BA', 'LastName': 'Lindsey', 'Affiliation': 'Department of Orthopaedics, Health Sciences Center, WVU School of Medicine, Morgantown, WV.'}, {'ForeName': 'Stephen T', 'Initials': 'ST', 'LastName': 'Duncan', 'Affiliation': 'Department of Orthopaedics, University of Kentucky, Lexington, KY.'}, {'ForeName': 'Jennifer M', 'Initials': 'JM', 'LastName': 'Eicher', 'Affiliation': 'Department of Orthopaedics, Health Sciences Center, WVU School of Medicine, Morgantown, WV.'}, {'ForeName': 'Jonathan D', 'Initials': 'JD', 'LastName': 'Gillig', 'Affiliation': 'Andrews Institute for Orthopaedics and Sports Medicine, Gulf Breeze, FL.'}, {'ForeName': 'Brett R', 'Initials': 'BR', 'LastName': 'Smith', 'Affiliation': 'Andrews Institute for Orthopaedics and Sports Medicine, Gulf Breeze, FL.'}, {'ForeName': 'G Daxton', 'Initials': 'GD', 'LastName': 'Steele', 'Affiliation': 'Andrews Institute for Orthopaedics and Sports Medicine, Gulf Breeze, FL.'}]",The Journal of arthroplasty,['10.1016/j.arth.2019.02.057'] 969,31788825,The effects of psychoeducation based on the cognitive-behavioral approach on premenstrual syndrome symptoms: A randomized controlled trial.,"PURPOSE The present study investigated the effects of psychoeducation based on a cognitive-behavioral approach on premenstrual syndrome (PMS) symptoms in young adult women. DESIGN AND METHODS The study was performed as a randomized controlled trial. The sample size was identified as 90 (45 intervention group/45 control group) students. The psychoeducation intervention consisted of five sessions performed over a 4-week period. FINDINGS There was a significant difference between the pretest and posttest total mean scores of the intervention group that received psychoeducation (P < .05). There was also a significant difference in depressive thoughts, irritability, and fatigue mean scores between the two groups (P < .05). PRACTICAL IMPLICATIONS The use of this approach and its inclusion in nursing care interventions is recommended to reduce PMS symptoms in young adult women.",2020,There was a significant difference between the pretest and posttest total mean scores of the intervention group that received psychoeducation (P < .05).,"['premenstrual syndrome symptoms', 'young adult women']","['psychoeducation based on a cognitive-behavioral approach', 'cognitive-behavioral approach']","['premenstrual syndrome (PMS) symptoms', 'depressive thoughts, irritability, and fatigue mean scores', 'PMS symptoms']","[{'cui': 'C0033046', 'cui_str': 'PMS - Premenstrual syndrome'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C0871175', 'cui_str': 'Psycho-education'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}]","[{'cui': 'C0033046', 'cui_str': 'PMS - Premenstrual syndrome'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C4319827', 'cui_str': 'Thought'}, {'cui': 'C0022107', 'cui_str': 'Irritable Mood'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.0400883,There was a significant difference between the pretest and posttest total mean scores of the intervention group that received psychoeducation (P < .05).,"[{'ForeName': 'Ceyda', 'Initials': 'C', 'LastName': 'Başoğul', 'Affiliation': 'Department of Nursing, Adıyaman University School of Health, Adıyaman, Turkey.'}, {'ForeName': 'Semiha', 'Initials': 'S', 'LastName': 'Aydın Özkan', 'Affiliation': 'Department of Midwifery, Adıyaman University School of Health, Adıyaman, Turkey.'}, {'ForeName': 'Türkan', 'Initials': 'T', 'LastName': 'Karaca', 'Affiliation': 'Department of Nursing, Adıyaman University School of Health, Adıyaman, Turkey.'}]",Perspectives in psychiatric care,['10.1111/ppc.12460'] 970,31943605,Comparison of three-dimensional and 4K imaging systems in novice surgeons: a cross-over study.,"BACKGROUND Laparoscopy has revolutionized the surgical field with the advent of minimally invasive techniques leading to smaller surgical wounds, enhanced recovery, early discharge from the hospital and early return to work. Since the initiation of three-dimensional (3D) systems, studies have failed to prove significant advantages over traditional two-dimensional systems which could be attributed to suboptimal image quality, poor illumination and high cost of earlier systems. Recent advances in stereoscopy have led to the introduction of high-definition (HD) systems with improvement in image quality in both two-dimensional and 3D systems. With HD and new 4K imaging system, the previous data are now obsolete. METHODS We devised a cross-over study using the Olympus 4K camera imaging system compared with the HD 3D systems using 40 novice surgeons with no prior surgical skills to perform standardized surgical tasks and the groups were crossed over to assess any difference in the learning curve with the imaging systems. RESULTS The data showed a statistically significant difference in errors performed with the 3D imaging system with reduction in errors for passing needle through a ring, knot tying, cutting circle and touching circles with a needle. The time taken to perform those tasks was comparable except in knot tying where there was significant reduction in the time taken to tie knots with a P-value of <0.001 in both groups. CONCLUSION The study showed no significant difference in the time to perform tasks. The precision of the tasks was significantly improved with the 3D systems.",2020,"The data showed a statistically significant difference in errors performed with the 3D imaging system with reduction in errors for passing needle through a ring, knot tying, cutting circle and touching circles with a needle.","['40 novice surgeons with no prior surgical skills', 'novice surgeons']",[],"['time to perform tasks', 'precision of the tasks']","[{'cui': 'C0582175', 'cui_str': 'Surgeon (occupation)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}]",[],"[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]",40.0,0.0235963,"The data showed a statistically significant difference in errors performed with the 3D imaging system with reduction in errors for passing needle through a ring, knot tying, cutting circle and touching circles with a needle.","[{'ForeName': 'Abdullah Muhammad', 'Initials': 'AM', 'LastName': 'Rana', 'Affiliation': 'Department of Colorectal Surgery, The Queen Elizabeth Hospital, Adelaide, South Australia, Australia.'}, {'ForeName': 'Abdul Ahad', 'Initials': 'AA', 'LastName': 'Rana', 'Affiliation': 'Department of Colorectal Surgery, The Queen Elizabeth Hospital, Adelaide, South Australia, Australia.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Hewett', 'Affiliation': 'Department of Colorectal Surgery, The Queen Elizabeth Hospital, Adelaide, South Australia, Australia.'}]",ANZ journal of surgery,['10.1111/ans.15653'] 971,31557056,Antithrombotic Therapy in Patients With Atrial Fibrillation and Acute Coronary Syndrome Treated Medically or With Percutaneous Coronary Intervention or Undergoing Elective Percutaneous Coronary Intervention: Insights From the AUGUSTUS Trial.,"BACKGROUND The safety and efficacy of antithrombotic regimens may differ between patients with atrial fibrillation who have acute coronary syndromes (ACS), treated medically or with percutaneous coronary intervention (PCI), and those undergoing elective PCI. METHODS Using a 2×2 factorial design, we compared apixaban with vitamin K antagonists and aspirin with placebo in patients with atrial fibrillation who had ACS or were undergoing PCI and were receiving a P2Y 12 inhibitor. We explored bleeding, death and hospitalization, as well as death and ischemic events, by antithrombotic strategy in 3 prespecified subgroups: patients with ACS treated medically, patients with ACS treated with PCI, and those undergoing elective PCI. RESULTS Of 4614 patients enrolled, 1097 (23.9%) had ACS treated medically, 1714 (37.3%) had ACS treated with PCI, and 1784 (38.8%) had elective PCI. Apixaban compared with vitamin K antagonist reduced International Society on Thrombosis and Haemostasis major or clinically relevant nonmajor bleeding in patients with ACS treated medically (hazard ratio [HR], 0.44 [95% CI, 0.28-0.68]), patients with ACS treated with PCI (HR, 0.68 [95% CI, 0.52-0.89]), and patients undergoing elective PCI (HR, 0.82 [95% CI, 0.64-1.04]; P interaction =0.052) and reduced death or hospitalization in the ACS treated medically (HR, 0.71 [95% CI, 0.54-0.92]), ACS treated with PCI (HR, 0.88 [95% CI, 0.74-1.06]), and elective PCI (HR, 0.87 [95% CI, 0.72-1.04]; P interaction =0.345) groups. Compared with vitamin K antagonists, apixaban resulted in a similar effect on death and ischemic events in the ACS treated medically, ACS treated with PCI, and elective PCI groups ( P interaction =0.356). Aspirin had a higher rate of bleeding than did placebo in patients with ACS treated medically (HR, 1.49 [95% CI, 0.98-2.26]), those with ACS treated with PCI (HR, 2.02 [95% CI, 1.53-2.67]), and those undergoing elective PCI (HR, 1.91 [95% CI, 1.48-2.47]; P interaction =0.479). For the same comparison, there was no difference in outcomes among the 3 groups for the composite of death or hospitalization ( P interaction =0.787) and death and ischemic events ( P interaction =0.710). CONCLUSIONS An antithrombotic regimen consisting of apixaban and a P2Y 12 inhibitor without aspirin provides superior safety and similar efficacy in patients with atrial fibrillation who have ACS, whether managed medically or with PCI, and those undergoing elective PCI compared with regimens that include vitamin K antagonists, aspirin, or both. CLINICAL TRIAL REGISTRATION URL: https://www.clinicaltrials.gov. Unique identifier: NCT02415400.",2019,"Compared with placebo, aspirin had a higher rate of bleeding than placebo in patients with ACS treated medically (HR 1.49, 95% CI 0.98-2.26), ACS treated with PCI (HR 2.02, 95% CI 1.53-2.67) and elective PCI groups (HR 1.91, 95% CI 1.48-2.47) (p interaction =0.479).","['patients with AF who have ACS, whether managed medically or with PCI, or those undergoing', 'Patients with Atrial Fibrillation and Acute Coronary Syndrome Treated Medically or with Percutaneous Coronary Intervention or Undergoing Elective Percutaneous Coronary Intervention', 'patients with AF who had ACS or were undergoing PCI and were receiving a P2Y12 inhibitor', '4614 patients enrolled, 1097 (23.9%) had ACS treated medically, 1714 (37.3%) had ACS treated with PCI, and 1784 (38.8%) had elective PCI', 'three pre-specified subgroups: patients with ACS treated medically, ACS treated with PCI, and those undergoing elective PCI', 'patients with atrial fibrillation (AF) who have acute coronary syndromes (ACS), treated medically or with percutaneous coronary intervention (PCI), and those undergoing elective PCI']","['Apixaban', 'apixaban with vitamin K antagonists (VKA) and aspirin with placebo', 'Antithrombotic Therapy', 'elective PCI', 'placebo', 'VKA, apixaban', 'antithrombotic regimens', 'apixaban and a P2Y12 inhibitor without aspirin', 'placebo, aspirin']","['reduced death or hospitalization', 'rate of bleeding', 'elective PCI', 'composite of death or hospitalization', 'ISTH major or CRNM bleeding', 'death and ischemic events', 'safety and efficacy', 'bleeding, death, and hospitalization as well as death and ischemic events']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}, {'cui': 'C0948089', 'cui_str': 'Acute Coronary Syndrome'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}]","[{'cui': 'C1831808', 'cui_str': 'apixaban'}, {'cui': 'C3653316', 'cui_str': 'Vitamin K antagonists'}, {'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0475224', 'cui_str': 'Ischemic (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",4614.0,0.115835,"Compared with placebo, aspirin had a higher rate of bleeding than placebo in patients with ACS treated medically (HR 1.49, 95% CI 0.98-2.26), ACS treated with PCI (HR 2.02, 95% CI 1.53-2.67) and elective PCI groups (HR 1.91, 95% CI 1.48-2.47) (p interaction =0.479).","[{'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Windecker', 'Affiliation': 'Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, Switzerland (S.W.).'}, {'ForeName': 'Renato D', 'Initials': 'RD', 'LastName': 'Lopes', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (R.D.L., T.M., C.B.G., G.H., W.S.J., J.H.A.).'}, {'ForeName': 'Tyler', 'Initials': 'T', 'LastName': 'Massaro', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (R.D.L., T.M., C.B.G., G.H., W.S.J., J.H.A.).'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Jones-Burton', 'Affiliation': 'Bristol-Myers Squibb, Lawrenceville, NJ (C.J.-B., R.A.).'}, {'ForeName': 'Christopher B', 'Initials': 'CB', 'LastName': 'Granger', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (R.D.L., T.M., C.B.G., G.H., W.S.J., J.H.A.).'}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'Aronson', 'Affiliation': 'Bristol-Myers Squibb, Lawrenceville, NJ (C.J.-B., R.A.).'}, {'ForeName': 'Gretchen', 'Initials': 'G', 'LastName': 'Heizer', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (R.D.L., T.M., C.B.G., G.H., W.S.J., J.H.A.).'}, {'ForeName': 'Shaun G', 'Initials': 'SG', 'LastName': 'Goodman', 'Affiliation': 'Canadian VIGOUR Center, University of Alberta, Edmonton, Canada (S.G.G., R.C.W.).'}, {'ForeName': 'Harald', 'Initials': 'H', 'LastName': 'Darius', 'Affiliation': 'Vivantes Neukoelln Medical Center, Berlin, Germany (H.D.).'}, {'ForeName': 'W Schuyler', 'Initials': 'WS', 'LastName': 'Jones', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (R.D.L., T.M., C.B.G., G.H., W.S.J., J.H.A.).'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Aschermann', 'Affiliation': 'Charles University, Prague, Czech Republic (M.A.).'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Brieger', 'Affiliation': 'Concord Clinical School, ANZAC Research Institute, University of Sydney, Australia (D.B.).'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Cura', 'Affiliation': 'Instituto Cardiovascular de Buenos Aires and Sanatorio Anchorena, Argentina (F.C.).'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Engstrøm', 'Affiliation': 'Rigshospital, University of Copenhagen, Denmark (T.E.).'}, {'ForeName': 'Viliam', 'Initials': 'V', 'LastName': 'Fridrich', 'Affiliation': 'National Institute of Cardiovascular Diseases, Bratislava, Slovakia (V.F.).'}, {'ForeName': 'Sigrun', 'Initials': 'S', 'LastName': 'Halvorsen', 'Affiliation': 'Oslo University Hospital Ulleval, University of Oslo, Norway (S.H.).'}, {'ForeName': 'Kurt', 'Initials': 'K', 'LastName': 'Huber', 'Affiliation': 'Wilhelminenhospital and Sigmund Freud University, Medical School, Vienna, Austria (K.H.).'}, {'ForeName': 'Hyun-Jae', 'Initials': 'HJ', 'LastName': 'Kang', 'Affiliation': 'Seoul National University Hospital, Seoul National University, Korea (H.-J.K.).'}, {'ForeName': 'Jose L', 'Initials': 'JL', 'LastName': 'Leiva-Pons', 'Affiliation': 'Hospital Central Dr Ignacio Morones Prieto, San Luis Potosi, Mexico (J.L.L.-P.).'}, {'ForeName': 'Basil S', 'Initials': 'BS', 'LastName': 'Lewis', 'Affiliation': 'Cardiovascular Clinical Research Institute, Lady Davis Carmel Medical Center, Haifa, Israel (B.S.L.).'}, {'ForeName': 'German', 'Initials': 'G', 'LastName': 'Malaga', 'Affiliation': 'CONEVID School of Medicine, Universidad Peruana Cayetano Heredia, Lima, Peru (G.M.).'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Meneveau', 'Affiliation': 'University Hospital Jean Minjoz, Besançon, France (N.M.).'}, {'ForeName': 'Bela', 'Initials': 'B', 'LastName': 'Merkely', 'Affiliation': 'Semmelweis University Heart and Vascular Center, Budapest, Hungary (B.M.).'}, {'ForeName': 'Davor', 'Initials': 'D', 'LastName': 'Milicic', 'Affiliation': 'University of Zagreb School of Medicine, University Hospital Centre, Croatia (D.M.).'}, {'ForeName': 'João', 'Initials': 'J', 'LastName': 'Morais', 'Affiliation': 'Hospital de Santo André, Leiria, Portugal (J.M.).'}, {'ForeName': 'Tatjana S', 'Initials': 'TS', 'LastName': 'Potpara', 'Affiliation': 'School of Medicine, Belgrade University, Serbia (T.S.P.).'}, {'ForeName': 'Dimitar', 'Initials': 'D', 'LastName': 'Raev', 'Affiliation': 'University Hospital St Anna, Sofia, Bulgaria (D.R.).'}, {'ForeName': 'Manel', 'Initials': 'M', 'LastName': 'Sabaté', 'Affiliation': 'University Heart Centre Lübeck, University Hospital Schleswig-Holstein, Germany (S.d.W.-T.).'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'de Waha-Thiele', 'Affiliation': 'German Center for Cardiovascular Research (DZHK), partner site Hamburg/Kiel/Lübeck, Lübeck (S.d.W.-T.).'}, {'ForeName': 'Robert C', 'Initials': 'RC', 'LastName': 'Welsh', 'Affiliation': 'Canadian VIGOUR Center, University of Alberta, Edmonton, Canada (S.G.G., R.C.W.).'}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Xavier', 'Affiliation': ""St John's Medical College and Research Institute, Bangalore, India (D.X.).""}, {'ForeName': 'Roxana', 'Initials': 'R', 'LastName': 'Mehran', 'Affiliation': 'Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, and Cardiovascular Research Foundation, New York, NY (R.M.).'}, {'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'Alexander', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (R.D.L., T.M., C.B.G., G.H., W.S.J., J.H.A.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Circulation,['10.1161/CIRCULATIONAHA.119.043308'] 972,31038755,"Fecal Microbial Transplant Capsules Are Safe in Hepatic Encephalopathy: A Phase 1, Randomized, Placebo-Controlled Trial.","Hepatic encephalopathy (HE) can cause major morbidity despite standard of care (SOC; rifaximin/lactulose). Fecal microbial transplant (FMT) enemas postantibiotics are safe, but the effect of FMT without antibiotics using the capsular route requires investigation. The aim of this work was to determine the safety, tolerability, and impact on mucosal/stool microbiota and brain function in HE after capsular FMT in a randomized, single-blind, placebo-controlled clinical trial in Virginia. Patients with cirrhosis with recurrent HE with MELD (Model for End-Stage Liver Disease) <17 on SOC were randomized 1:1 into receiving 15 FMT capsules versus placebo from a single donor enriched in Lachnospiraceae and Ruminococcaceae. Endoscopies with duodenal and sigmoid biopsies, stool analysis, cognition, serum lipopolysaccharide-binding protein (LBP), and duodenal antimicrobial peptide (AMP) expression at baseline were used. Clinical follow-up with SOC maintenance was performed until 5 months. FMT-assigned patients underwent repeat endoscopies 4 weeks postenrollment. Twenty subjects on lactulose/rifaximin were randomized 1:1. MELD score was similar at baseline (9.6 vs. 10.2) and study end (10.2 vs. 10.5). Six patients in the placebo group required hospitalizations compared to 1 in FMT, which was deemed unrelated to FMT. Infection/HE episodes were similar between groups. Baseline microbial diversity was similar in all tissues between groups. Post-FMT, duodenal mucosal diversity (P = 0.01) increased with higher Ruminococcaceae and Bifidobacteriaceae and lower Streptococcaceae and Veillonellaceae. Reduction in Veillonellaceae were noted post-FMT in sigmoid (P = 0.04) and stool (P = 0.05). Duodenal E-cadherin (P = 0.03) and defensin alpha 5 (P = 0.03) increased whereas interleukin-6 (P = 0.02) and serum LBP (P = 0.009) reduced post-FMT. EncephalApp performance improved post-FMT only (P = 0.02). Conclusion: In this phase 1 study, oral FMT capsules are safe and well tolerated in patients with cirrhosis and recurrent HE. FMT was associated with improved duodenal mucosal diversity, dysbiosis, and AMP expression, reduced LBP, and improved EncephalApp performance. Further studies are needed to prove efficacy.",2019,Duodenal E-cadherin (P = 0.03) and defensin alpha 5,"['17 on SOC', 'Twenty subjects on', 'Patients with cirrhosis with recurrent HE with MELD (Model for End-Stage Liver Disease', 'patients with cirrhosis and recurrent HE', 'Hepatic Encephalopathy', 'Virginia']","['lactulose/rifaximin', 'placebo', 'Placebo', 'FMT capsules versus placebo', 'FMT']","['EncephalApp performance improved post-FMT', 'safe and well tolerated', 'Post-FMT, duodenal mucosal diversity', 'hospitalizations', 'Reduction in Veillonellaceae', 'serum LBP', 'higher Ruminococcaceae and Bifidobacteriaceae and lower Streptococcaceae and Veillonellaceae', 'HE episodes', 'Duodenal E-cadherin', 'Baseline microbial diversity', 'safety, tolerability, and impact on mucosal/stool microbiota and brain function', 'interleukin-6', 'MELD score', 'duodenal mucosal diversity, dysbiosis, and AMP expression, reduced LBP, and improved EncephalApp performance', 'Endoscopies with duodenal and sigmoid biopsies, stool analysis, cognition, serum lipopolysaccharide-binding protein (LBP), and duodenal antimicrobial peptide (AMP) expression']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1623038', 'cui_str': 'Cirrhosis'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C3826979', 'cui_str': 'MELD-Model for end-stage liver disease'}, {'cui': 'C0019151', 'cui_str': 'Portal-Systemic Encephalopathy'}, {'cui': 'C0042753', 'cui_str': 'Virginia'}]","[{'cui': 'C0022957', 'cui_str': 'Lactulose'}, {'cui': 'C0073374', 'cui_str': 'rifaximin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0013303', 'cui_str': 'Duodenum'}, {'cui': 'C0026724', 'cui_str': 'Mucosal Tissue'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0042447', 'cui_str': 'Acidaminococcaceae'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C2584567', 'cui_str': 'Ruminococcaceae'}, {'cui': 'C1003847', 'cui_str': 'Family Bifidobacteriaceae'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0038394', 'cui_str': 'Streptococcaceae'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0042172', 'cui_str': 'Cadherin-1'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C4048785', 'cui_str': 'MELD score'}, {'cui': 'C3658208', 'cui_str': 'Disbiosis'}, {'cui': 'C0645200', 'cui_str': 'diphosphoribosyl-adenosine monophosphate'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0227391', 'cui_str': 'Sigmoid'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0202010', 'cui_str': 'Feces examination - general (procedure)'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0065054', 'cui_str': 'LPS-binding protein'}, {'cui': 'C1136254', 'cui_str': 'Microbicides'}, {'cui': 'C0030956', 'cui_str': 'Peptides'}]",20.0,0.423193,Duodenal E-cadherin (P = 0.03) and defensin alpha 5,"[{'ForeName': 'Jasmohan S', 'Initials': 'JS', 'LastName': 'Bajaj', 'Affiliation': 'Gastroenterology, Hepatology and Nutrition, Virginia Commonwealth University, Richmond, VA.'}, {'ForeName': 'Nita H', 'Initials': 'NH', 'LastName': 'Salzman', 'Affiliation': 'Pediatrics and Microbiology and Immunology, Medical College of Wisconsin, Milwaukee, WI.'}, {'ForeName': 'Chathur', 'Initials': 'C', 'LastName': 'Acharya', 'Affiliation': 'Gastroenterology, Hepatology and Nutrition, Virginia Commonwealth University, Richmond, VA.'}, {'ForeName': 'Richard K', 'Initials': 'RK', 'LastName': 'Sterling', 'Affiliation': 'Gastroenterology, Hepatology and Nutrition, Virginia Commonwealth University, Richmond, VA.'}, {'ForeName': 'Melanie B', 'Initials': 'MB', 'LastName': 'White', 'Affiliation': 'Gastroenterology, Hepatology and Nutrition, Virginia Commonwealth University, Richmond, VA.'}, {'ForeName': 'Edith A', 'Initials': 'EA', 'LastName': 'Gavis', 'Affiliation': 'Gastroenterology, Hepatology and Nutrition, Virginia Commonwealth University, Richmond, VA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Fagan', 'Affiliation': 'Gastroenterology, Hepatology and Nutrition, Virginia Commonwealth University, Richmond, VA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Hayward', 'Affiliation': 'Pediatrics and Microbiology and Immunology, Medical College of Wisconsin, Milwaukee, WI.'}, {'ForeName': 'Mary L', 'Initials': 'ML', 'LastName': 'Holtz', 'Affiliation': 'Pediatrics and Microbiology and Immunology, Medical College of Wisconsin, Milwaukee, WI.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Matherly', 'Affiliation': 'Gastroenterology, Hepatology and Nutrition, Virginia Commonwealth University, Richmond, VA.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Lee', 'Affiliation': 'Gastroenterology, Hepatology and Nutrition, Virginia Commonwealth University, Richmond, VA.'}, {'ForeName': 'Majdi', 'Initials': 'M', 'LastName': 'Osman', 'Affiliation': 'OpenBiome, Somerville, MA.'}, {'ForeName': 'Mohammad S', 'Initials': 'MS', 'LastName': 'Siddiqui', 'Affiliation': 'OpenBiome, Somerville, MA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Fuchs', 'Affiliation': 'Pediatrics and Microbiology and Immunology, Medical College of Wisconsin, Milwaukee, WI.'}, {'ForeName': 'Puneet', 'Initials': 'P', 'LastName': 'Puri', 'Affiliation': 'Pediatrics and Microbiology and Immunology, Medical College of Wisconsin, Milwaukee, WI.'}, {'ForeName': 'Masoumeh', 'Initials': 'M', 'LastName': 'Sikaroodi', 'Affiliation': 'Microbiome Analysis Center, George Mason University, Manassas, VA.'}, {'ForeName': 'Patrick M', 'Initials': 'PM', 'LastName': 'Gillevet', 'Affiliation': 'Microbiome Analysis Center, George Mason University, Manassas, VA.'}]","Hepatology (Baltimore, Md.)",['10.1002/hep.30690'] 973,31553203,Clinically Significant Bleeding With Ticagrelor Versus Clopidogrel in Korean Patients With Acute Coronary Syndromes Intended for Invasive Management: A Randomized Clinical Trial.,"BACKGROUND Owing to the differential propensity for bleeding and ischemic events with response to antiplatelet therapy, the safety and effectiveness of potent P2Y12 inhibitor ticagrelor in East Asian populations remain uncertain. METHODS In this multicenter trial, 800 Korean patients hospitalized for acute coronary syndromes with or without ST elevation and intended for invasive management were randomly assigned to receive, in a 1:1 ratio, ticagrelor (180 mg loading dose, 90 mg twice daily thereafter) or clopidogrel (600 mg loading dose, 75 mg daily thereafter). The primary safety outcome was clinically significant bleeding (a composite of major bleeding or minor bleeding according to PLATO (Platelet Inhibition and Patient Outcomes) criteria at 12 months. RESULTS At 12 months, the incidence of clinically significant bleeding was significantly higher in the ticagrelor group than in the clopidogrel group (11.7% [45/400] vs 5.3% [21/400]; hazard ratio [HR], 2.26; 95% confidence interval [CI], 1.34 to 3.79; P =0.002). The incidences of major bleeding (7.5% [29/400] vs 4.1% [16/400], P =0.04) and fatal bleeding (1% [4/400] vs 0%, P =0.04) were also higher in the ticagrelor group. The incidence of death from cardiovascular causes, myocardial infarction, or stroke was not significantly different between the ticagrelor group and the clopidogrel group (9.2% [36/400] vs 5.8% [23/400]; HR, 1.62; 95% CI, 0.96 to 2.74; P =0.07). Overall safety and effectiveness findings were similar with the use of several different analytic methods and in multiple subgroups. CONCLUSIONS In Korean acute coronary syndrome patients intended to receive early invasive management, standard-dose ticagrelor as compared with clopidogrel was associated with a higher incidence of clinically significant bleeding. The numerically higher incidence of ischemic events should be interpreted with caution, given the present trial was underpowered to draw any conclusion regarding efficacy. CLINICAL TRIAL REGISTRATION URL: https://www.clinicaltrials.gov. Unique identifier: NCT02094963.",2019,,['Korean Patients'],"['Ticagrelor Versus Clopidogrel', 'Invasive Management']",[],"[{'cui': 'C1556095', 'cui_str': 'Koreans'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}]",[],,0.179473,,"[{'ForeName': 'Duk-Woo', 'Initials': 'DW', 'LastName': 'Park', 'Affiliation': 'Division of Cardiology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea (D.W.P., H.P., D.Y.K., J.M.A., P.H.L., S.W.L., S.W.P., S.J.P.).'}, {'ForeName': 'Osung', 'Initials': 'O', 'LastName': 'Kwon', 'Affiliation': ""Division of Cardiology, Department of Internal Medicine, The Catholic University of Korea, Eunpyeong St. Mary's Hospital, Seoul, Korea (O.K.).""}, {'ForeName': 'Jae-Sik', 'Initials': 'JS', 'LastName': 'Jang', 'Affiliation': 'Inje University Busan Paik Hospital, Busan, Korea (J.S.J.).'}, {'ForeName': 'Sung-Cheol', 'Initials': 'SC', 'LastName': 'Yun', 'Affiliation': 'Division of Biostatistics, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea (S.C.Y.).'}, {'ForeName': 'Hanbit', 'Initials': 'H', 'LastName': 'Park', 'Affiliation': 'Division of Cardiology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea (D.W.P., H.P., D.Y.K., J.M.A., P.H.L., S.W.L., S.W.P., S.J.P.).'}, {'ForeName': 'Do-Yoon', 'Initials': 'DY', 'LastName': 'Kang', 'Affiliation': 'Division of Cardiology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea (D.W.P., H.P., D.Y.K., J.M.A., P.H.L., S.W.L., S.W.P., S.J.P.).'}, {'ForeName': 'Jung-Min', 'Initials': 'JM', 'LastName': 'Ahn', 'Affiliation': 'Division of Cardiology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea (D.W.P., H.P., D.Y.K., J.M.A., P.H.L., S.W.L., S.W.P., S.J.P.).'}, {'ForeName': 'Pil Hyung', 'Initials': 'PH', 'LastName': 'Lee', 'Affiliation': 'Division of Cardiology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea (D.W.P., H.P., D.Y.K., J.M.A., P.H.L., S.W.L., S.W.P., S.J.P.).'}, {'ForeName': 'Seung-Whan', 'Initials': 'SW', 'LastName': 'Lee', 'Affiliation': 'Division of Cardiology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea (D.W.P., H.P., D.Y.K., J.M.A., P.H.L., S.W.L., S.W.P., S.J.P.).'}, {'ForeName': 'Seong-Wook', 'Initials': 'SW', 'LastName': 'Park', 'Affiliation': 'Division of Cardiology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea (D.W.P., H.P., D.Y.K., J.M.A., P.H.L., S.W.L., S.W.P., S.J.P.).'}, {'ForeName': 'Si Wan', 'Initials': 'SW', 'LastName': 'Choi', 'Affiliation': 'Chungnam National University Hospital, Daejeon, Korea (S.W.C.).'}, {'ForeName': 'Sang-Gon', 'Initials': 'SG', 'LastName': 'Lee', 'Affiliation': 'Ulsan University Hospital, Ulsan, Korea (S.G.L.).'}, {'ForeName': 'Hyuck-Jun', 'Initials': 'HJ', 'LastName': 'Yoon', 'Affiliation': 'Keimyung University Dongsan Medical Center, Daegu, Korea (H.J.Y.).'}, {'ForeName': 'Taehoon', 'Initials': 'T', 'LastName': 'Ahn', 'Affiliation': 'Gachon University Gil Hospital, Incheon, Korea (T.A.).'}, {'ForeName': 'Moo Hyun', 'Initials': 'MH', 'LastName': 'Kim', 'Affiliation': 'Dong-A University Medical Center, Busan, Korea (M.H.K.).'}, {'ForeName': 'Deuk Young', 'Initials': 'DY', 'LastName': 'Nah', 'Affiliation': 'Dongguk University Gyeongju Hospital, Gyeongju, Korea (D.Y.N.).'}, {'ForeName': 'Sung Yun', 'Initials': 'SY', 'LastName': 'Lee', 'Affiliation': 'Inje University Ilsan Paik Hospital, Ilsan, Korea (S.Y.L.).'}, {'ForeName': 'Jei Keon', 'Initials': 'JK', 'LastName': 'Chae', 'Affiliation': 'Chonbuk National University Hospital, Jeonju, Korea (J.K.C.).'}, {'ForeName': 'Seung-Jung', 'Initials': 'SJ', 'LastName': 'Park', 'Affiliation': 'Division of Cardiology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea (D.W.P., H.P., D.Y.K., J.M.A., P.H.L., S.W.L., S.W.P., S.J.P.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Circulation,['10.1161/CIRCULATIONAHA.119.041766'] 974,31776029,"Immunogenicity, transplacental transfer of pertussis antibodies and safety following pertussis immunization during pregnancy: Evidence from a randomized, placebo-controlled trial.","BACKGROUND Pertussis immunization during pregnancy is recommended in many countries. Data from large randomized controlled trials are needed to assess the immunogenicity, reactogenicity and safety of this approach. METHODS This phase IV, observer-blind, randomized, placebo-controlled, multicenter trial assessed immunogenicity, transplacental transfer of maternal pertussis antibodies, reactogenicity and safety of a reduced-antigen-content diphtheria-tetanus-three-component acellular pertussis vaccine (Tdap) during pregnancy. Women received Tdap or placebo at 27-36 weeks' gestation with crossover ≤ 72-hour-postpartum immunization. Immune responses were assessed before the pregnancy dose and 1 month after, and from the umbilical cord at delivery. Superiority (primary objective) was reached if the lower limits of the 95% confidence intervals (CIs) of the pertussis geometric mean concentration (GMC) ratios (Tdap/control) in cord blood were ≥ 1.5. Solicited and unsolicited adverse events (AEs) and pregnancy-/neonate-related AEs of interest were recorded. RESULTS 687 pregnant women were vaccinated (Tdap: N = 341 control: N = 346). Superiority of the pertussis immune response (maternally transferred pertussis antibodies in cord blood) was demonstrated by the GMC ratios (Tdap/control): 16.1 (95% CI: 13.5-19.2) for anti-filamentous hemagglutinin, 20.7 (15.9-26.9) for anti-pertactin and 8.5 (7.0-10.2) for anti-pertussis toxoid. Rates of pregnancy-/neonate-related AEs of interest, solicited general and unsolicited AEs were similar between groups. None of the serious AEs reported throughout the study were considered related to maternal Tdap vaccination. CONCLUSIONS Tdap vaccination during pregnancy resulted in high levels of pertussis antibodies in cord blood, was well tolerated and had an acceptable safety profile. This supports the recommendation of Tdap vaccination during pregnancy to prevent early-infant pertussis disease. CLINICAL TRIAL REGISTRATION ClinicalTrials.gov: NCT02377349.",2020,"Superiority of the pertussis immune response (maternally transferred pertussis antibodies in cord blood) was demonstrated by the GMC ratios (Tdap/control): 16.1 (95% CI: 13.5-19.2) for anti-filamentous hemagglutinin, 20.7 (15.9-26.9) for anti-pertactin and 8.5 (7.0-10.2) for anti-pertussis toxoid.",['687 pregnant women were vaccinated (Tdap: N\u202f=\u202f341 control: N\u202f=\u202f346'],"['placebo', 'Tdap vaccination', 'Tdap or placebo', 'reduced-antigen-content diphtheria-tetanus-three-component acellular pertussis vaccine (Tdap']","['pertussis geometric mean concentration (GMC) ratios (Tdap/control) in cord blood', 'Immune responses', 'Solicited and unsolicited adverse events (AEs) and pregnancy-/neonate-related AEs of interest', 'immunogenicity, transplacental transfer of maternal pertussis antibodies, reactogenicity and safety', 'immunogenicity, reactogenicity and safety']","[{'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0003320', 'cui_str': 'Antigens'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C0012546', 'cui_str': 'Corynebacterium diphtheriae Infection'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0982332', 'cui_str': 'acellular pertussis vaccine, inactivated'}]","[{'cui': 'C0043167', 'cui_str': 'Pertussis'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0162371', 'cui_str': 'Cord Blood'}, {'cui': 'C0301872', 'cui_str': 'Immune response, function (observable entity)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0442375', 'cui_str': 'Transplacental approach (qualifier value)'}, {'cui': 'C0040671', 'cui_str': 'Transfer'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",687.0,0.699142,"Superiority of the pertussis immune response (maternally transferred pertussis antibodies in cord blood) was demonstrated by the GMC ratios (Tdap/control): 16.1 (95% CI: 13.5-19.2) for anti-filamentous hemagglutinin, 20.7 (15.9-26.9) for anti-pertactin and 8.5 (7.0-10.2) for anti-pertussis toxoid.","[{'ForeName': 'Kirsten P', 'Initials': 'KP', 'LastName': 'Perrett', 'Affiliation': ""Murdoch Children's Research Institute and Melbourne School of Population and Global Health, University of Melbourne, Melbourne, Australia. Electronic address: kirsten.perrett@rch.org.au.""}, {'ForeName': 'Scott A', 'Initials': 'SA', 'LastName': 'Halperin', 'Affiliation': 'Dalhousie University, Canadian Center for Vaccinology, Halifax, Canada. Electronic address: scott.halperin@dal.ca.'}, {'ForeName': 'Terry', 'Initials': 'T', 'LastName': 'Nolan', 'Affiliation': ""Murdoch Children's Research Institute and Melbourne School of Population and Global Health, University of Melbourne, Melbourne, Australia. Electronic address: t.nolan@unimelb.edu.au.""}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Martínez Pancorbo', 'Affiliation': 'Instituto Sevillano de la Mujer-Instituto Hispalense de Pediatría, Seville, Spain.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Tapiero', 'Affiliation': 'CHU Sainte Justine, Université de Montréal, Montréal, Canada. Electronic address: b.tapiero@umontreal.ca.'}, {'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Martinón-Torres', 'Affiliation': 'Translational Pediatrics and Infectious Diseases, Pediatrics Department, Hospital Clínico Universitario de Santiago de Compostela and Genetics, Vaccines and Pediatrics Research Group, University of Santiago de Compostela, Instituto de Investigación Sanitaria de Santiago de Compostela, Santiago de Compostela, Spain. Electronic address: federico.martinon.torres@sergas.es.'}, {'ForeName': 'Zbynek', 'Initials': 'Z', 'LastName': 'Stranak', 'Affiliation': 'Institute for the Care of Mother and Child, Prague, Czech Republic. Electronic address: z.stranak@seznam.cz.'}, {'ForeName': 'Miia', 'Initials': 'M', 'LastName': 'Virta', 'Affiliation': 'Tampere Vaccine Research Center, Tampere University, Tampere, Finland. Electronic address: miia.virta@staff.uta.fi.'}, {'ForeName': 'Otto G', 'Initials': 'OG', 'LastName': 'Vanderkooi', 'Affiliation': ""Alberta Children's Hospital, University of Calgary, Alberta, Calgary, Canada. Electronic address: ovanderk@ucalgary.ca.""}, {'ForeName': 'Pavel', 'Initials': 'P', 'LastName': 'Kosina', 'Affiliation': 'University Hospital, Hradec Kralove, Czech Republic. Electronic address: kosinpav@seznam.cz.'}, {'ForeName': 'Maria Begoña', 'Initials': 'MB', 'LastName': 'Encinas Pardilla', 'Affiliation': 'Hospital Universitario Puerta de Hierro, Majadahonda, Spain.'}, {'ForeName': 'Ignacio', 'Initials': 'I', 'LastName': 'Cristobal García', 'Affiliation': 'Universidad Francisco de Vitoria, Madrid, Spain. Electronic address: icristobalg@sego.es.'}, {'ForeName': 'Gian Vincenzo', 'Initials': 'GV', 'LastName': 'Zuccotti', 'Affiliation': 'Ospedale dei Bambini Vittore Buzzi and University of Milan, Milan, Italy. Electronic address: gianvincenzo.zuccotti@unimi.it.'}, {'ForeName': 'Lusine', 'Initials': 'L', 'LastName': 'Kostanyan', 'Affiliation': 'Modis, C/O GSK, Wavre, Belgium. Electronic address: lusine.x.kostanyan@gsk.com.'}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Meyer', 'Affiliation': 'GSK, Wavre, Belgium. Electronic address: nadia.x.meyer@gsk.com.'}, {'ForeName': 'Maria Angeles', 'Initials': 'MA', 'LastName': 'Ceregido', 'Affiliation': 'GSK, Wavre, Belgium. Electronic address: maria-angeles.x.ceregido@gsk.com.'}, {'ForeName': 'Brigitte', 'Initials': 'B', 'LastName': 'Cheuvart', 'Affiliation': 'GSK, Wavre, Belgium. Electronic address: brigitte.cheuvart@gsk.com.'}, {'ForeName': 'Sherine O', 'Initials': 'SO', 'LastName': 'Kuriyakose', 'Affiliation': 'GSK, Bangalore, India. Electronic address: sherine.o.kuriyakose@gsk.com.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Marcos Fernández', 'Affiliation': 'Hospital Monteprincipe, Boadilla del Monte, Spain. Electronic address: mmarcos@egom.es.'}, {'ForeName': 'Miguel Ángel', 'Initials': 'MÁ', 'LastName': 'Rodríguez Zambrano', 'Affiliation': 'Hospital HM Puerta del Sur, Móstoles, Spain.'}, {'ForeName': 'Adrián', 'Initials': 'A', 'LastName': 'Martín García', 'Affiliation': 'Nuevo Hospital Universitario de Burgos, Burgos, Spain.'}, {'ForeName': 'Juan Eloy', 'Initials': 'JE', 'LastName': 'Asenjo de la Fuente', 'Affiliation': 'Hospital Clínico San Carlos, Madrid, Spain. Electronic address: eloyasenjo@telefonica.net.'}, {'ForeName': 'Maria Dolores', 'Initials': 'MD', 'LastName': 'Camacho Marín', 'Affiliation': 'Hospital Clínico San Carlos, Madrid, Spain.'}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'de la Calle Fernández-Miranda', 'Affiliation': 'Hospital La Paz, Madrid, Spain.'}, {'ForeName': 'Yolanda', 'Initials': 'Y', 'LastName': 'Romero Espinar', 'Affiliation': 'Hospital Quirónsalud Málaga, Málaga, Spain.'}, {'ForeName': 'Paola Giovanna', 'Initials': 'PG', 'LastName': 'Marchisio', 'Affiliation': 'Università degli Studi di Milano, Milan, Italy. Electronic address: paola.marchisio@unimi.it.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Manzoni', 'Affiliation': ""Ospedale Ostetrico Ginecologico Sant'Anna, Turin, Italy and Department of Maternal-Infant-Pediatric Health, Degli Infermi Hospital, Biella, Italy.""}, {'ForeName': 'Narcisa', 'Initials': 'N', 'LastName': 'Mesaros', 'Affiliation': 'GSK, Wavre, Belgium. Electronic address: narcisa.x.mesaros@gsk.com.'}]",Vaccine,['10.1016/j.vaccine.2019.10.105'] 975,30861532,Endoscopic tissue shielding to prevent bleeding after endoscopic submucosal dissection: a prospective multicenter randomized controlled trial.,"BACKGROUND Bleeding after endoscopic submucosal dissection (ESD) is a severe adverse event. Recent reports have described the efficacy of the endoscopic shielding method with polyglycolic acid (PGA) sheets and fibrin glue for the prevention of adverse events after ESD. The aim of the present study was to investigate whether the PGA shielding method provides additional benefit in preventing post-ESD bleeding compared with standard care. METHODS This was a prospective, multicenter, randomized controlled trial. Patients at high risk of post-ESD bleeding were enrolled in the study. Before ESD, patients were randomized to either the PGA group or the control group. After completing ESD in the PGA group, PGA sheets were placed onto the ulcer floor and adhered with fibrin glue. The primary end point was the post-ESD bleeding rate. RESULTS 140 eligible patients were enrolled from September 2014 to September 2016, and 137 were included in the intention-to-treat analysis (67 in the PGA group and 70 in the control group). Post-ESD bleeding occurred in three patients (4.5 %) in the PGA group and in four patients (5.7 %) in the control group; there was no significant difference between the two groups ( P  > 0.99). Post-ESD bleeding tended to occur later in the control group than in the PGA group (median 12.5 days [range 8 - 14] vs. 2 days [range 0 - 7], respectively). CONCLUSION The PGA shielding method did not demonstrate a significant effect on the prevention of post-ESD bleeding.",2019,Post-ESD bleeding occurred in three patients (4.5 %) in the PGA group and in four patients (5.7 %) in the control group; there was no significant difference between the two groups ( P  > 0.99).,"['140 eligible patients were enrolled from September 2014 to September 2016, and 137 were included in the intention-to-treat analysis (67 in the PGA group and 70 in the control group', 'Patients at high risk of post-ESD bleeding were enrolled in the study']","['endoscopic submucosal dissection (ESD', 'polyglycolic acid (PGA) sheets and fibrin glue', 'PGA', 'fibrin glue', 'Endoscopic tissue shielding']","['Post-ESD bleeding', 'prevention of post-ESD bleeding', 'post-ESD bleeding rate']","[{'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4517569', 'cui_str': 'One hundred and thirty-seven'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C0085409', 'cui_str': 'Polyendocrinopathies, Autoimmune'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332167', 'cui_str': 'High risk of (contextual qualifier) (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C1700929', 'cui_str': 'Endoscopic Submucosal Dissection'}, {'cui': 'C0032502', 'cui_str': 'Polyglycolide'}, {'cui': 'C0439643', 'cui_str': 'Sheets (qualifier value)'}, {'cui': 'C0016004', 'cui_str': 'Fibrin Glue'}, {'cui': 'C0085409', 'cui_str': 'Polyendocrinopathies, Autoimmune'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}]","[{'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}]",140.0,0.0500468,Post-ESD bleeding occurred in three patients (4.5 %) in the PGA group and in four patients (5.7 %) in the control group; there was no significant difference between the two groups ( P  > 0.99).,"[{'ForeName': 'Yosuke', 'Initials': 'Y', 'LastName': 'Kataoka', 'Affiliation': 'Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Yosuke', 'Initials': 'Y', 'LastName': 'Tsuji', 'Affiliation': 'Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Kingo', 'Initials': 'K', 'LastName': 'Hirasawa', 'Affiliation': 'Division of Endoscopy, Yokohama City University Medical Center, Kanagawa, Japan.'}, {'ForeName': 'Kengo', 'Initials': 'K', 'LastName': 'Takimoto', 'Affiliation': 'Department of Gastroenterology, Takeda General Hospital, Kyoto, Japan.'}, {'ForeName': 'Tomonori', 'Initials': 'T', 'LastName': 'Wada', 'Affiliation': 'Department of Gastroenterology, Sanraku Hospital, Tokyo, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Mochizuki', 'Affiliation': 'Shinagawa Gut Clinic, Tokyo, Japan.'}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Ohata', 'Affiliation': 'Department of Gastroenterology, NTT Medical Center Tokyo, Tokyo, Japan.'}, {'ForeName': 'Yoshiki', 'Initials': 'Y', 'LastName': 'Sakaguchi', 'Affiliation': 'Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Keiko', 'Initials': 'K', 'LastName': 'Niimi', 'Affiliation': 'Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Ono', 'Affiliation': 'Department of Gastroenterology, Chiba-Nishi General Hospital, Matsudo, Japan.'}, {'ForeName': 'Shinya', 'Initials': 'S', 'LastName': 'Kodashima', 'Affiliation': 'Department of Gastroenterology, Teikyo University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Nobutake', 'Initials': 'N', 'LastName': 'Yamamichi', 'Affiliation': 'Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Mitsuhiro', 'Initials': 'M', 'LastName': 'Fujishiro', 'Affiliation': 'Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Kazuhiko', 'Initials': 'K', 'LastName': 'Koike', 'Affiliation': 'Department of Gastroenterology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.'}]",Endoscopy,['10.1055/a-0860-5280'] 976,31230988,Baseline characteristics did not identify people with low back pain who respond best to a Movement System Impairment-Based classification treatment.,"STUDY DESIGN Secondary analysis of data from a randomized controlled trial. BACKGROUND Treatment based on the Movement System Impairment-Based classification for chronic low back pain results in the same benefit when compared to other forms of exercise. It is possible that participant's characteristics measured at baseline can identify people with chronic low back pain who would respond best to a treatment based on the Movement System Impairment model. OBJECTIVES To assess if specific characteristics of people with chronic low back pain measured at baseline can modify the effects of a treatment based on the Movement System Impairment model on pain and disability. METHODS Four variables assessed at baseline that could potentially modify the treatment effects of the treatment based on the Movement System Impairment model were selected (age, educational status, physical activity status and STarT back tool classification). Separate univariate models were used to investigate a possible modifier treatment effect of baseline participant's characteristics on pain and disability after the treatment. Findings of interaction values above 1 point for the outcome mean pain intensity or above 3 points for disability (Roland Morris questionnaire) were considered clinically relevant. RESULTS Linear regression analyses for the outcomes of pain and disability did not show interaction values considered clinically relevant for age, educational status, physical activity status and STarT back tool classification. CONCLUSION Age, educational status, physical activity status and STarT back tool classification did not modify the effects of an 8-week treatment based on the Movement System Impairment model in patients with chronic low back pain. Registered at www.clinicaltrials.gov: NCT02221609 (https://clinicaltrials.gov/ct2/show/NCT02221609).",2019,"RESULTS Linear regression analyses for the outcomes of pain and disability did not show interaction values considered clinically relevant for age, educational status, physical activity status and STarT back tool classification. ","['patients with chronic low back pain', 'people with chronic low back pain']",[],"['educational status, physical activity status and STarT back tool classification', 'pain and disability']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain (finding)'}]",[],"[{'cui': 'C0013658', 'cui_str': 'Educational Achievement'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0336791', 'cui_str': 'Tool, device (physical object)'}, {'cui': 'C0008903', 'cui_str': 'taxonomy'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}]",,0.151896,"RESULTS Linear regression analyses for the outcomes of pain and disability did not show interaction values considered clinically relevant for age, educational status, physical activity status and STarT back tool classification. ","[{'ForeName': 'Daniel Camara', 'Initials': 'DC', 'LastName': 'Azevedo', 'Affiliation': 'Programa de Mestrado e Doutorado em Fisioterapia, Universidade Cidade de São Paulo, São Paulo, SP, Brazil; Departamento de Fisioterapia, Pontifícia Universidade Católica de Minas Gerais, Belo Horizonte, MG, Brazil. Electronic address: danielazevedo@pucminas.br.'}, {'ForeName': 'Paulo Henrique', 'Initials': 'PH', 'LastName': 'Ferreira', 'Affiliation': 'Faculty of Health Sciences, University of Sydney, Sydney, Australia.'}, {'ForeName': 'Henrique de Oliveira', 'Initials': 'HO', 'LastName': 'Santos', 'Affiliation': 'Departamento de Fisioterapia, Pontifícia Universidade Católica de Minas Gerais, Belo Horizonte, MG, Brazil.'}, {'ForeName': 'Daniel Ribeiro', 'Initials': 'DR', 'LastName': 'Oliveira', 'Affiliation': 'Departamento de Fisioterapia, Pontifícia Universidade Católica de Minas Gerais, Belo Horizonte, MG, Brazil.'}, {'ForeName': 'Joao Victor Leite de', 'Initials': 'JVL', 'LastName': 'Souza', 'Affiliation': 'Departamento de Fisioterapia, Pontifícia Universidade Católica de Minas Gerais, Belo Horizonte, MG, Brazil.'}, {'ForeName': 'Leonardo Oliveira Pena', 'Initials': 'LOP', 'LastName': 'Costa', 'Affiliation': 'Programa de Mestrado e Doutorado em Fisioterapia, Universidade Cidade de São Paulo, São Paulo, SP, Brazil; Musculoskeletal Division, The George Institute for Global Health, Sydney, NSW, Australia.'}]",Brazilian journal of physical therapy,['10.1016/j.bjpt.2019.05.006'] 977,31221619,"Epacadostat plus pembrolizumab versus placebo plus pembrolizumab in patients with unresectable or metastatic melanoma (ECHO-301/KEYNOTE-252): a phase 3, randomised, double-blind study.","BACKGROUND Immunotherapy combination treatments can improve patient outcomes. Epacadostat, an IDO1 selective inhibitor, and pembrolizumab, a PD-1 inhibitor, showed promising antitumour activity in the phase 1-2 ECHO-202/KEYNOTE-037 study in advanced melanoma. In this trial, we aimed to compare progression-free survival and overall survival in patients with unresectable stage III or IV melanoma receiving epacadostat plus pembrolizumab versus placebo plus pembrolizumab. METHODS In this international, randomised, placebo-controlled, double-blind, parallel-group, phase 3 trial, eligible participants were aged 18 years or older, with unresectable stage III or IV melanoma previously untreated with PD-1 or PD-L1 checkpoint inhibitors, an ECOG performance status of 0 or 1, and had a known BRAF V600 mutant status or consented to BRAF V600 mutation testing during screening. Patients were stratified by PD-L1 expression and BRAF V600 mutation status and randomly assigned (1:1) through a central interactive voice and integrated web response system to receive epacadostat 100 mg orally twice daily plus pembrolizumab 200 mg intravenously every 3 weeks or placebo plus pembrolizumab for up to 2 years. We used block randomisation with a block size of four in each stratum. Primary endpoints were progression-free survival and overall survival in the intention-to-treat population. The safety analysis population included randomly assigned patients who received at least one dose of study treatment. The study was stopped after the second interim analysis; follow-up for safety is ongoing. This study is registered with ClinicalTrials.gov, number NCT02752074. FINDINGS Between June 21, 2016, and Aug 7, 2017, 928 patients were screened and 706 patients were randomly assigned to receive epacadostat plus pembrolizumab (n=354) or placebo plus pembrolizumab (n=352). Median follow-up was 12·4 months (IQR 10·3-14·5). No significant differences were found between the treatment groups for progression-free survival (median 4·7 months, 95% CI 2·9-6·8, for epacadostat plus pembrolizumab vs 4·9 months, 2·9-6·8, for placebo plus pembrolizumab; hazard ratio [HR] 1·00, 95% CI 0·83-1·21; one-sided p=0·52) or overall survival (median not reached in either group; epacadostat plus pembrolizumab vs placebo plus pembrolizumab: HR 1·13, 0·86-1·49; one-sided p=0·81). The most common grade 3 or worse treatment-related adverse event was lipase increase, which occurred in 14 (4%) of 353 patients receiving epacadostat plus pembrolizumab and 11 (3%) of 352 patients receiving placebo plus pembrolizumab. Treatment-related serious adverse events were reported in 37 (10%) of 353 patients receiving epacadostat plus pembrolizumab and 32 (9%) of 352 patients receiving placebo plus pembrolizumab. There were no treatment-related deaths in either treatment group. INTERPRETATION Epacadostat 100 mg twice daily plus pembrolizumab did not improve progression-free survival or overall survival compared with placebo plus pembrolizumab in patients with unresectable or metastatic melanoma. The usefulness of IDO1 inhibition as a strategy to enhance anti-PD-1 therapy activity in cancer remains uncertain. FUNDING Incyte Corporation, in collaboration with Merck Sharp & Dohme.",2019,Median follow-up was 12·4 months,"['Between June 21, 2016, and Aug 7, 2017, 928 patients were screened and 706 patients', 'Patients were stratified by PD-L1 expression and BRAF V600 mutation status and randomly assigned (1:1) through a', 'eligible participants were aged 18 years or older, with unresectable stage III or IV melanoma previously untreated with PD-1 or PD-L1 checkpoint inhibitors, an ECOG performance status of 0 or 1, and had a known BRAF V600 mutant status or consented to BRAF V600 mutation testing during screening', 'patients with unresectable or metastatic melanoma', 'patients with unresectable or metastatic melanoma (ECHO-301/KEYNOTE-252', 'patients with unresectable stage III or IV melanoma receiving epacadostat plus pembrolizumab versus placebo plus pembrolizumab']","['epacadostat plus pembrolizumab', 'central interactive voice and integrated web response system to receive epacadostat 100 mg orally twice daily plus pembrolizumab 200 mg intravenously every 3 weeks or placebo plus pembrolizumab', 'placebo', 'Epacadostat plus pembrolizumab', 'IDO1 inhibition', 'placebo plus pembrolizumab', 'pembrolizumab']","['progression-free survival', 'progression-free survival and overall survival', 'progression-free survival or overall survival', 'serious adverse events', 'deaths', 'overall survival']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205363', 'cui_str': 'Stratified (qualifier value)'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0026882', 'cui_str': 'Mutation'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3 (qualifier value)'}, {'cui': 'C0025202', 'cui_str': 'Malignant Melanoma'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C1520224', 'cui_str': 'Eastern Cooperative Oncology Group performance status'}, {'cui': 'C0205309', 'cui_str': 'Known (qualifier value)'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0278883', 'cui_str': 'Metastatic melanoma'}, {'cui': 'C4086265', 'cui_str': 'epacadostat'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C4086265', 'cui_str': 'epacadostat'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",928.0,0.7993,Median follow-up was 12·4 months,"[{'ForeName': 'Georgina V', 'Initials': 'GV', 'LastName': 'Long', 'Affiliation': 'Melanoma Institute Australia, University of Sydney, Royal North Shore and Mater Hospitals, Sydney, NSW, Australia. Electronic address: georgina.long@sydney.edu.au.'}, {'ForeName': 'Reinhard', 'Initials': 'R', 'LastName': 'Dummer', 'Affiliation': 'Department of Dermatology, University Hospital Zürich, Zurich, Switzerland.'}, {'ForeName': 'Omid', 'Initials': 'O', 'LastName': 'Hamid', 'Affiliation': 'The Angeles Clinic and Research Institute, Los Angeles, CA, USA.'}, {'ForeName': 'Thomas F', 'Initials': 'TF', 'LastName': 'Gajewski', 'Affiliation': 'Department of Pathology, University of Chicago Medical Center, Chicago, IL, USA.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Caglevic', 'Affiliation': 'Oncology Department, Clinica Alemana Santiago, Universidad del Desarrollo, Santiago, Chile.'}, {'ForeName': 'Stephane', 'Initials': 'S', 'LastName': 'Dalle', 'Affiliation': 'Hospices Civils De Lyon, Cancer Research Center of Lyon, Claude Bernard University Lyon, Pierre Benite, France.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Arance', 'Affiliation': 'Medical Oncology, Hospital Clínic de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Matteo S', 'Initials': 'MS', 'LastName': 'Carlino', 'Affiliation': 'Westmead and Blacktown Hospitals, Melanoma Institute Australia, University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Jean-Jacques', 'Initials': 'JJ', 'LastName': 'Grob', 'Affiliation': 'Service de Dermatologie et Cancérologie Cutanée, Aix-Marseille University, Marseille, France.'}, {'ForeName': 'Tae Min', 'Initials': 'TM', 'LastName': 'Kim', 'Affiliation': 'Department of Haemato-Oncology, Seoul National University Hospital, Seoul, South Korea.'}, {'ForeName': 'Lev', 'Initials': 'L', 'LastName': 'Demidov', 'Affiliation': 'N N Blokhin Russian Cancer Research Center, Moscow, Russia.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Robert', 'Affiliation': 'Gustave Roussy Comprehensive Cancer Center, Villejuif, France.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Larkin', 'Affiliation': 'The Royal Marsden NHS Foundation Trust, London, UK.'}, {'ForeName': 'James R', 'Initials': 'JR', 'LastName': 'Anderson', 'Affiliation': 'Merck & Co, Inc, Kenilworth, NJ, USA.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Maleski', 'Affiliation': 'Incyte Corporation, Wilmington, DE, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Jones', 'Affiliation': 'Incyte Corporation, Wilmington, DE, USA.'}, {'ForeName': 'Scott J', 'Initials': 'SJ', 'LastName': 'Diede', 'Affiliation': 'Merck & Co, Inc, Kenilworth, NJ, USA.'}, {'ForeName': 'Tara C', 'Initials': 'TC', 'LastName': 'Mitchell', 'Affiliation': 'Abramson Cancer Center, University of Pennsylvania, Philadelphia, PA, USA.'}]",The Lancet. Oncology,['10.1016/S1470-2045(19)30274-8'] 978,31791396,Cognitive behavioural therapy for insomnia (CBTi) as a treatment for tinnitus-related insomnia: protocol for a randomised controlled trial.,"BACKGROUND A significant proportion of patients with chronic tinnitus report clinical levels of sleep disturbance (insomnia). Despite the significant health and functioning implications of this, no rigorous trials have investigated treatments that target tinnitus-related insomnia. This is the first randomised controlled trial evaluating Cognitive Behavioural Therapy for insomnia (CBTi) in tinnitus compared with other psychological treatments. METHODS/DESIGN The study will test the efficacy of group CBTi as a treatment for tinnitus-related insomnia in a single-centre randomised controlled trial. Participants will be 102 patients with chronic, clinically significant tinnitus and insomnia in the absence of organic sleep disorders. Participants will be randomised to one of three intervention arms: six sessions of CBTi or six sessions of sleep support group or two sessions of audiologically based care. The primary outcomes will be changes in sleep as measured on the Insomnia Severity Index and key outcomes on a 2-week sleep diary (sleep efficiency and total sleep time). Outcomes will be collected 3, 10, 14 and 34 weeks post-randomisation. Secondary measures include sleep quality, sleep beliefs, tinnitus severity, psychological distress and quality of life. A sub-sample of participants will provide two weeks of actigraphy data at the same time points. Data on satisfaction and treatment experience will be collected at 10 and 34 weeks post-randomisation from all participants. DISCUSSION Findings from the study will be submitted to a peer-reviewed journal. It is anticipated that findings may inform future clinical practice in the treatment of tinnitus-related insomnia. TRIAL REGISTRATION ClinicalTrials.gov, NCT03386123. Retrospectively registered on 29 December 2017.",2019,"This is the first randomised controlled trial evaluating Cognitive Behavioural Therapy for insomnia (CBTi) in tinnitus compared with other psychological treatments. ","['patients with chronic tinnitus report clinical levels of sleep disturbance (insomnia', '102 patients with chronic, clinically significant tinnitus and insomnia in the absence of organic sleep disorders', 'Retrospectively registered on 29 December 2017']","['Cognitive Behavioural Therapy', 'CBTi', 'Cognitive behavioural therapy for insomnia (CBTi', 'CBTi or six sessions of sleep support group or two sessions of audiologically based care']","['sleep quality, sleep beliefs, tinnitus severity, psychological distress and quality of life', 'changes in sleep as measured on the Insomnia Severity Index and key outcomes on a 2-week sleep diary (sleep efficiency and total sleep time']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0700201', 'cui_str': 'Dyssomnias'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0040264', 'cui_str': 'Ringing-Buzzing-Tinnitus'}, {'cui': 'C0332197', 'cui_str': 'Absent (qualifier value)'}, {'cui': 'C1561892', 'cui_str': 'Organic sleep disorder'}, {'cui': 'C0600375', 'cui_str': 'Registers'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0036606', 'cui_str': 'Support Groups'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0040264', 'cui_str': 'Ringing-Buzzing-Tinnitus'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0034380'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C4520529', 'cui_str': 'Insomnia severity index (assessment scale)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0376660', 'cui_str': 'Diary'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",,0.175754,"This is the first randomised controlled trial evaluating Cognitive Behavioural Therapy for insomnia (CBTi) in tinnitus compared with other psychological treatments. ","[{'ForeName': 'E', 'Initials': 'E', 'LastName': 'Marks', 'Affiliation': 'Department of Psychology, University of Bath, Claverton Down, Bath, BA7 2AY, UK. e.marks@bath.ac.uk.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Hallsworth', 'Affiliation': 'Imperial College London, 535 Huxley Building, South Kensington Campus, London, UK.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'McKenna', 'Affiliation': ""Royal National Throat Nose and Ear Hospital, 330 Gray's Inn Road, London, WC1X 8DA, UK.""}]",Trials,['10.1186/s13063-019-3778-5'] 979,31564057,Efficacy and safety of dupilumab in Japanese adults with moderate-to-severe atopic dermatitis: a subanalysis of three clinical trials.,"BACKGROUND Dupilumab, a human monoclonal antibody, blocks the shared receptor unit for interleukin-4 and interleukin-13. International phase II and III studies have evaluated the efficacy and safety of dupilumab in adults with moderate-to-severe atopic dermatitis (AD), but the effects of dupilumab in Japanese patients have not been reported. OBJECTIVES To evaluate the efficacy and safety of dupilumab in Japanese patients with moderate-to-severe AD. METHODS We analysed the efficacy and safety of dupilumab in the Japanese cohorts of a 16-week, phase IIb dose-finding trial (AD-1021; NCT01859988); a 16-week, phase III, placebo-controlled monotherapy trial (LIBERTY AD SOLO 1; NCT02277743) and a 52-week, phase III, placebo-controlled study of dupilumab with topical corticosteroids (LIBERTY AD CHRONOS; NCT02260986). RESULTS Twenty-seven, 106 and 117 Japanese patients were enrolled in AD-1021, SOLO 1 and CHRONOS, respectively. Baseline disease severity was numerically higher in the Japanese cohort than in the overall study population. Generally, dupilumab significantly improved signs and symptoms of AD, including pruritus and patient quality of life, compared with placebo in the Japanese cohort, consistent with the overall study population. The combined safety profile of dupilumab in the Japanese cohort was similar to that in the total study populations; dupilumab was associated with an increased incidence of injection-site reactions and conjunctivitis compared with placebo. Dupilumab was associated with rapid reduction in thymus and activation-regulated chemokine and gradual IgE reductions. CONCLUSIONS Dupilumab alone or with topical corticosteroids improved signs and symptoms of AD, had an acceptable safety profile, and suppressed biomarkers of type 2 inflammation compared with placebo in Japanese adult patients with moderate-to-severe AD. What's already known about this topic? Differences in atopic dermatitis (AD) pathology have been reported between Asian and Western populations, in which distinct helper T-cell activation profiles have been observed. International clinical studies in adults with moderate-to-severe AD have evaluated the efficacy and safety of dupilumab, which blocks interleukin-4 and interleukin-13, key molecules in type 2 inflammation. The effects of dupilumab in Japanese patients specifically have not yet been reported. What does this study add? Dupilumab alone or with topical corticosteroids improved signs and symptoms of AD and had an acceptable safety profile compared with placebo in Japanese patients with moderate-to-severe AD. The effects were comparable with those observed in the overall study population. Reported immunological differences in AD pathology in Asian patients may be secondary to type 2 immune activation.",2020,"BACKGROUND Dupilumab, a human monoclonal antibody, blocks the shared receptor unit for interleukin-4 and interleukin-13.","['Japanese adults with moderate-to-severe atopic dermatitis', 'Twenty-seven, 106, and 117 Japanese patients enrolled in AD-1021, SOLO 1 and CHRONOS, respectively', 'adults with moderate-to-severe atopic dermatitis (AD', 'Japanese adult patients with moderate-to-severe AD', 'Japanese patients with moderate-to-severe AD']","['placebo-controlled monotherapy', 'dupilumab with topical corticosteroids (TCS, LIBERTY AD', 'placebo', 'Dupilumab alone or with TCS', 'dupilumab']","['Baseline disease severity', 'efficacy and safety', 'signs and symptoms of AD, including pruritus, and patient quality of life', 'Efficacy and safety']","[{'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0011615', 'cui_str': 'Neurodermatitis, Disseminated'}, {'cui': 'C4319602', 'cui_str': '27'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C3660996', 'cui_str': 'dupilumab'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}]","[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0037088', 'cui_str': 'Signs and Symptoms'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0033774', 'cui_str': 'Pruritis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0034380'}]",117.0,0.0559352,"BACKGROUND Dupilumab, a human monoclonal antibody, blocks the shared receptor unit for interleukin-4 and interleukin-13.","[{'ForeName': 'N', 'Initials': 'N', 'LastName': 'Katoh', 'Affiliation': 'Department of Dermatology, Kyoto Prefectural University of Medicine Graduate School of Medical Science, Kyoto, Japan.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Kataoka', 'Affiliation': 'Department of Dermatology, Osaka Habikino Medical Center, Osaka, Japan.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Saeki', 'Affiliation': 'Department of Dermatology, Nippon Medical School, Tokyo, Japan.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Hide', 'Affiliation': 'Department of Dermatology, Hiroshima University, Hiroshima, Japan.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Kabashima', 'Affiliation': 'Department of Dermatology, Kyoto University Graduate School of Medicine, Kyoto, Japan.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Etoh', 'Affiliation': 'Department of Dermatology, Tokyo Teishin Postal Services Agency Hospital, Tokyo, Japan.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Igarashi', 'Affiliation': 'Department of Dermatology, NTT Medical Center Tokyo, Tokyo, Japan.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Imafuku', 'Affiliation': 'Department of Dermatology, Fukuoka University, Fukuoka, Japan.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Kawashima', 'Affiliation': ""Department of Dermatology, Tokyo Women's Medical University, School of Medicine, Tokyo, Japan.""}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Ohtsuki', 'Affiliation': 'Department of Dermatology, Jichi Medical University, Tochigi, Japan.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Fujita', 'Affiliation': 'Sanofi K.K., Tokyo, Japan.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Arima', 'Affiliation': 'Sanofi K.K., Tokyo, Japan.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Takagi', 'Affiliation': 'Sanofi K.K., Tokyo, Japan.'}, {'ForeName': 'Z', 'Initials': 'Z', 'LastName': 'Chen', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, NY, U.S.A.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Shumel', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, NY, U.S.A.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Ardeleanu', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, NY, U.S.A.'}]",The British journal of dermatology,['10.1111/bjd.18565'] 980,31585796,Effect of a fluid bolus on cardiovascular collapse among critically ill adults undergoing tracheal intubation (PrePARE): a randomised controlled trial.,"BACKGROUND Tracheal intubation is common in the care of critically ill adults and is frequently complicated by hypotension, cardiac arrest, or death. We aimed to evaluate administration of an intravenous fluid bolus to prevent cardiovascular collapse during intubation of critically ill adults. METHODS We did a pragmatic, multicentre, unblinded, randomised trial in nine sites (eight ICUs and one emergency department) around the USA. Critically ill adults (≥18 years) undergoing tracheal intubation were randomly assigned (1:1, block sizes of 2, 4, and 6, stratified by study site) to either an intravenous infusion of 500 mL of crystalloid solution or no fluid bolus. The primary outcome, assessed in the intention-to-treat population, was cardiovascular collapse, defined as a new systolic blood pressure <65 mm Hg; new or increased vasopressor receipt between induction and 2 min after tracheal intubation; or cardiac arrest or death within 1 h of tracheal intubation. Adverse events were assessed in the as-treated population. This trial, which is now complete, is registered with ClinicalTrials.gov, number NCT03026777. FINDINGS Patients were enrolled from Feb 6, 2017, to Jan 9, 2018, when the data and safety monitoring board stopped the trial on the basis of futility. By trial termination, 337 (63%) of 537 screened adults had been randomly assigned. Cardiovascular collapse occurred in 33 (20%) of 168 patients in the fluid bolus group compared with 31 (18%) of 169 patients in the no fluid bolus group (absolute difference 1·3% [95% CI -7·1% to 9·7%]; p=0·76). The individual components of the cardiovascular collapse composite outcome did not differ between groups (new systolic blood pressure <65 mm Hg 11 [7%] in the bolus group vs ten [6%] in the no-bolus group, new or increased vasopressor 32 [19%] vs 31 [18%], cardiac arrest within 1 h seven [4%] vs two [1%], death within 1 h of intubation two [1%] vs one [1%]). In-hospital mortality was not significantly different in the fluid bolus group (48 [29%]) compared with no fluid bolus (59 [35%]). INTERPRETATION Administration of an intravenous fluid bolus did not decrease the overall incidence of cardiovascular collapse during tracheal intubation of critically ill adults compared with no fluid bolus in this trial. FUNDING US National Institutes of Health.",2019,"INTERPRETATION Administration of an intravenous fluid bolus did not decrease the overall incidence of cardiovascular collapse during tracheal intubation of critically ill adults compared with no fluid bolus in this trial. ","['Critically ill adults (≥18 years) undergoing tracheal intubation', 'critically ill adults undergoing tracheal intubation (PrePARE', 'critically ill adults', 'Patients were enrolled from Feb 6, 2017, to Jan 9, 2018, when the data and safety monitoring board stopped the trial on the basis of futility', 'nine sites (eight ICUs and one emergency department) around the USA', '337 (63%) of 537 screened adults had been randomly assigned']","['fluid bolus', 'intravenous fluid bolus', 'intravenous infusion of 500 mL of crystalloid solution or no fluid bolus']","['intention-to-treat population, was cardiovascular collapse, defined as a new systolic blood pressure <65 mm Hg; new or increased vasopressor receipt', 'cardiac arrest', 'cardiac arrest or death within 1 h of tracheal intubation', 'cardiovascular collapse', 'Cardiovascular collapse', 'death', 'hospital mortality', 'Adverse events', 'overall incidence of cardiovascular collapse', 'systolic blood pressure']","[{'cui': 'C0010340', 'cui_str': 'Critically Ill'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0021932', 'cui_str': 'Intubation, Endotracheal'}, {'cui': 'C4082130', 'cui_str': 'Prepared (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0949757', 'cui_str': 'Data and Safety Monitoring Boards'}, {'cui': 'C0450446', 'cui_str': 'Stops (attribute)'}, {'cui': 'C1626935', 'cui_str': 'Base'}, {'cui': 'C0086322', 'cui_str': 'Futility'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}]","[{'cui': 'C0444611', 'cui_str': 'Fluid - descriptor'}, {'cui': 'C1289919', 'cui_str': 'Intravenous fluid'}, {'cui': 'C0021440', 'cui_str': 'Infusions, Intravenous'}, {'cui': 'C3816747', 'cui_str': 'Five hundred'}, {'cui': 'C0056562', 'cui_str': 'Crystalloid'}]","[{'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0036974', 'cui_str': 'Circulatory Collapse'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0018790', 'cui_str': 'Cardiac Arrest'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0700308', 'cui_str': 'Protium (substance)'}, {'cui': 'C0021932', 'cui_str': 'Intubation, Endotracheal'}, {'cui': 'C0085556', 'cui_str': 'Mortalities, In-house'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220856', 'cui_str': 'incidence'}]",168.0,0.742292,"INTERPRETATION Administration of an intravenous fluid bolus did not decrease the overall incidence of cardiovascular collapse during tracheal intubation of critically ill adults compared with no fluid bolus in this trial. ","[{'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Janz', 'Affiliation': 'Department of Medicine, Section of Pulmonary, Critical Care Medicine, and Allergy and Immunology, Louisiana State University School of Medicine New Orleans, New Orleans, LA, USA. Electronic address: djanz@lsuhsc.edu.'}, {'ForeName': 'Jonathan D', 'Initials': 'JD', 'LastName': 'Casey', 'Affiliation': 'Department of Medicine, Division of Allergy, Pulmonary and Critical Care Medicine, Vanderbilt University School of Medicine, Nashville, TN, USA.'}, {'ForeName': 'Matthew W', 'Initials': 'MW', 'LastName': 'Semler', 'Affiliation': 'Department of Medicine, Division of Allergy, Pulmonary and Critical Care Medicine, Vanderbilt University School of Medicine, Nashville, TN, USA.'}, {'ForeName': 'Derek W', 'Initials': 'DW', 'LastName': 'Russell', 'Affiliation': 'Department of Medicine, Division of Pulmonary, Allergy and Critical Care Medicine, University of Alabama at Birmingham, AL, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Dargin', 'Affiliation': 'Department of Medicine, Division of Pulmonary and Critical Care Medicine, Lahey Hospital and Medical Center, Burlington, MA, USA.'}, {'ForeName': 'Derek J', 'Initials': 'DJ', 'LastName': 'Vonderhaar', 'Affiliation': 'Section of Emergency Medicine, Louisiana State University School of Medicine New Orleans, New Orleans, LA, USA; Department of Pulmonary and Critical Care Medicine, Ochsner Health System New Orleans, New Orleans, LA USA.'}, {'ForeName': 'Kevin M', 'Initials': 'KM', 'LastName': 'Dischert', 'Affiliation': 'Department of Medicine, Division of Pulmonary and Critical Care, University of Washington School of Medicine, Seattle, WA, USA.'}, {'ForeName': 'Jason R', 'Initials': 'JR', 'LastName': 'West', 'Affiliation': 'Department of Emergency Medicine, Lincoln Medical Center, The Bronx, New York, NY, USA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Stempek', 'Affiliation': 'Department of Medicine, Division of Pulmonary and Critical Care Medicine, Lahey Hospital and Medical Center, Burlington, MA, USA.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Wozniak', 'Affiliation': 'Department of Medicine, Division of Pulmonary and Critical Care Medicine, Lahey Hospital and Medical Center, Burlington, MA, USA.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Caputo', 'Affiliation': 'Department of Emergency Medicine, Lincoln Medical Center, The Bronx, New York, NY, USA.'}, {'ForeName': 'Brent E', 'Initials': 'BE', 'LastName': 'Heideman', 'Affiliation': 'Department of Medicine, Division of Allergy, Pulmonary and Critical Care Medicine, Vanderbilt University School of Medicine, Nashville, TN, USA.'}, {'ForeName': 'Aline N', 'Initials': 'AN', 'LastName': 'Zouk', 'Affiliation': 'Department of Medicine, Division of Pulmonary, Allergy and Critical Care Medicine, University of Alabama at Birmingham, AL, USA.'}, {'ForeName': 'Swati', 'Initials': 'S', 'LastName': 'Gulati', 'Affiliation': 'Department of Medicine, Division of Pulmonary, Allergy and Critical Care Medicine, University of Alabama at Birmingham, AL, USA.'}, {'ForeName': 'William S', 'Initials': 'WS', 'LastName': 'Stigler', 'Affiliation': 'Department of Medicine, Division of Pulmonary, Allergy and Critical Care Medicine, University of Alabama at Birmingham, AL, USA.'}, {'ForeName': 'Itay', 'Initials': 'I', 'LastName': 'Bentov', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Aaron M', 'Initials': 'AM', 'LastName': 'Joffe', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Todd W', 'Initials': 'TW', 'LastName': 'Rice', 'Affiliation': 'Department of Medicine, Division of Allergy, Pulmonary and Critical Care Medicine, Vanderbilt University School of Medicine, Nashville, TN, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Respiratory medicine,['10.1016/S2213-2600(19)30246-2'] 981,30714026,"Pharmacist-Led, Technology-Assisted Study to Improve Medication Safety, Cardiovascular Risk Factor Control, and Racial Disparities in Kidney Transplant Recipients.","Introduction Health disparities in African-American (AA) kidney transplant recipients compared with non-AA recipients are well established. Cardiovascular disease (CVD) risk control is a significant mediator of this disparity. Objective To assess the efficacy of improved medication safety, CVD risk control, and racial disparities in kidney transplant recipients. Methods Prospective, pharmacist-led, technology-aided, 6-month interventional clinical trial. A total of 60 kidney recipients with diabetes and hypertension were enrolled. Patients had to be at least one-year post transplant with stable graft function. Primary outcome measured included hypertension, diabetes, and lipid control using intent-to-treat analyses, with differences assessed between AA and non-AA recipients. Results The participants mean age was 59 years, with 42% being female and 68% being AA. Overall, patients demonstrated improvements in blood pressure <140/90 mmHg (baseline 50% vs. end of study 68%, p=0.054) and hemoglobin A1c <7% (baseline 33% vs. end of study 47%, p=0.061). AAs demonstrated a significant reduction from baseline in systolic blood pressure (-0.86 mmHg per month, p=0.026), which was not evident in non-AAs (-0.13 mmHg per month, p=0.865). Mean HgbA1c decreased from baseline in the overall group (-0.12% per month, p=0.003), which was similar within AAs (-0.11% per month, p=0.004) and non-AAs (-0.14% per month, p=0.029). There were no changes in low-density lipoproteins, triglycerides, or high-density lipoproteins over the course of the study. Medication errors were significantly reduced and self-reported medication adherence significantly improved over the course of the study. Conclusion These results demonstrate the potential efficacy of a pharmacist-led, technology-aided, educational intervention in improving medication safety, diabetes, and hypertension and reducing racial disparities in AA kidney transplant recipients. (ClinicalTrials.gov NCT02763943).",2018,"There were no changes in low-density lipoproteins, triglycerides, or high-density lipoproteins over the course of the study.","['Patients had to be at least one-year post transplant with stable graft function', '60 kidney recipients with diabetes and hypertension were enrolled', 'AA kidney transplant recipients', 'participants mean age was 59 years, with 42% being female and 68% being AA', 'kidney transplant recipients', 'Kidney Transplant Recipients', 'African-American (AA) kidney transplant recipients']",[],"['Medication errors', 'blood pressure', 'medication safety, diabetes, and hypertension and reducing racial disparities', 'hemoglobin A1c', 'medication adherence', 'hypertension, diabetes, and lipid control using intent-to-treat analyses', 'low-density lipoproteins, triglycerides, or high-density lipoproteins', 'systolic blood pressure', 'Mean HgbA1c', 'medication safety, CVD risk control, and racial disparities', 'Medication Safety, Cardiovascular Risk Factor Control, and Racial Disparities']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0332835', 'cui_str': 'Grafts'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C1527362', 'cui_str': 'grafts'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0022646', 'cui_str': 'Kidney'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0022671', 'cui_str': 'Grafting, Kidney'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}]",[],"[{'cui': 'C4087540', 'cui_str': 'Medication errors (SMQ)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C4521595', 'cui_str': 'Lcpl'}, {'cui': 'C2364172', 'cui_str': 'Medication Adherence'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1283828', 'cui_str': 'Intentional'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement (procedure)'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}]",60.0,0.0591913,"There were no changes in low-density lipoproteins, triglycerides, or high-density lipoproteins over the course of the study.","[{'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Taber', 'Affiliation': 'Division of Transplant Surgery, College of Medicine, Medical University of South Carolina, Charleston, SC.'}, {'ForeName': 'Mulugeta', 'Initials': 'M', 'LastName': 'Gebregziabher', 'Affiliation': 'Department of Public Health Sciences, College of Medicine, Medical University of South Carolina, Charleston, SC.'}, {'ForeName': 'Aurora', 'Initials': 'A', 'LastName': 'Posadas', 'Affiliation': 'Division of Transplant Nephrology, College of Medicine, Medical University of South Carolina, Charleston, SC.'}, {'ForeName': 'Caitlin', 'Initials': 'C', 'LastName': 'Schaffner', 'Affiliation': 'Division of Transplant Surgery, College of Medicine, Medical University of South Carolina, Charleston, SC.'}, {'ForeName': 'Leonard E', 'Initials': 'LE', 'LastName': 'Egede', 'Affiliation': 'Division of General Internal Medicine, Medical College of Wisconsin, Milwaukee, WI.'}, {'ForeName': 'Prabhakar K', 'Initials': 'PK', 'LastName': 'Baliga', 'Affiliation': 'Department of Surgery, College of Medicine, Medical University of South Carolina, Charleston, SC.'}]",Journal of the American College of Clinical Pharmacy : JACCP,['10.1002/jac5.1024'] 982,31076415,"Efficacy and Safety of Fast-Acting Insulin Aspart Compared With Insulin Aspart, Both in Combination With Insulin Degludec, in Children and Adolescents With Type 1 Diabetes: The onset 7 Trial.","OBJECTIVE To confirm efficacy and safety of fast-acting insulin aspart (faster aspart) versus insulin aspart (IAsp), both with basal insulin degludec, in a pediatric population with type 1 diabetes. RESEARCH DESIGN AND METHODS After a 12-week run-in, this treat-to-target, 26-week, multicenter trial randomized participants (1 to <18 years) to double-blind mealtime faster aspart ( n = 260), mealtime IAsp ( n = 258), or open-label postmeal faster aspart ( n = 259). The primary end point was change from baseline in glycated hemoglobin (HbA 1c ) after 26 weeks of treatment. All available information regardless of treatment discontinuation was used for the evaluation of treatment effect. RESULTS At week 26, mealtime and postmeal faster aspart were noninferior to IAsp regarding change from baseline in HbA 1c ( P < 0.001 for noninferiority [0.4% margin]), with a statistically significant difference in favor of mealtime faster aspart (estimated treatment difference -0.17% [95% CI -0.30; -0.03], -1.82 mmol/mol [-3.28; -0.36]; P = 0.014). Change from baseline in 1-h postprandial glucose increment significantly favored mealtime faster aspart versus IAsp at breakfast, main evening meal, and over all meals ( P < 0.01 for all). No statistically significant differences in the overall rate of severe or blood glucose-confirmed hypoglycemia were observed. Mean total daily insulin dose was 0.92 units/kg for mealtime faster aspart, 0.92 units/kg for postmeal faster aspart, and 0.88 units/kg for mealtime IAsp. CONCLUSIONS In children and adolescents with type 1 diabetes, mealtime and postmeal faster aspart with insulin degludec provided effective glycemic control with no additional safety risks versus IAsp. Mealtime faster aspart provided superior HbA 1c control compared with IAsp.",2019,No statistically significant differences in the overall rate of severe or blood glucose-confirmed hypoglycemia were observed.,"['Children and Adolescents With Type 1 Diabetes', 'pediatric population with type 1 diabetes']","['Insulin Aspart, Both in Combination With Insulin Degludec', 'double-blind mealtime faster aspart ( n = 260), mealtime IAsp ( n = 258), or open-label postmeal faster aspart', 'fast-acting insulin aspart (faster aspart) versus insulin aspart (IAsp', 'Fast-Acting Insulin Aspart']","['overall rate of severe or blood glucose-confirmed hypoglycemia', 'Efficacy and Safety', 'glycated hemoglobin (HbA 1c ', 'Mean total daily insulin dose']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0123677', 'cui_str': 'Insulin, Aspart, Human'}, {'cui': 'C3491971', 'cui_str': 'insulin degludec'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0587119', 'cui_str': 'Meal Times'}, {'cui': 'C4517669', 'cui_str': 'Two hundred and sixty'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}]",,0.102615,No statistically significant differences in the overall rate of severe or blood glucose-confirmed hypoglycemia were observed.,"[{'ForeName': 'Bruce W', 'Initials': 'BW', 'LastName': 'Bode', 'Affiliation': 'Atlanta Diabetes Associates, Atlanta, GA bbode001@gmail.com.'}, {'ForeName': 'Violeta', 'Initials': 'V', 'LastName': 'Iotova', 'Affiliation': 'University Hospital St. Marina, Medical University Varna, Varna, Bulgaria.'}, {'ForeName': 'Margarita', 'Initials': 'M', 'LastName': 'Kovarenko', 'Affiliation': 'Pediatric Department, Novosibirsk State Medical University of the Ministry of Health of the Russian Federation, Novosibirsk, Russia.'}, {'ForeName': 'Lori M', 'Initials': 'LM', 'LastName': 'Laffel', 'Affiliation': 'Joslin Diabetes Center, Harvard Medical School, Boston, MA.'}, {'ForeName': 'Paturi V', 'Initials': 'PV', 'LastName': 'Rao', 'Affiliation': 'Diabetes Research Society, Hyderabad, India.'}, {'ForeName': 'Srikanth', 'Initials': 'S', 'LastName': 'Deenadayalan', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Magnus', 'Initials': 'M', 'LastName': 'Ekelund', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Steffen Falgreen', 'Initials': 'SF', 'LastName': 'Larsen', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Danne', 'Affiliation': ""Children's Hospital Auf der Bult, Hannover, Germany.""}]",Diabetes care,['10.2337/dc19-0009'] 983,31894444,Pathways for HIV Prevention Behaviors Following a Home-Based Couples Intervention for Pregnant Women and Male Partners in Kenya.,"Pregnancy is a time of heightened HIV risk, but also a phase when a couple can prioritize family health. We conducted secondary analysis of a home-based intervention in rural Kenya to explore couple-level adherence to HIV prevention behaviors. The intervention included health education, relationship-building skills, and Couples HIV Testing and Counseling. Pregnant women were randomized to the intervention (n = 64) or standard care (n = 63) along with male partners. Of 96 couples, 82 (85.0%) were followed to 3 months postpartum, when 31.0% of couples reported perfect adherence to HIV prevention. In logistic regression, intervention condition couples had three-fold higher odds of perfect adherence (AOR = 3.07, 95% CI = 1.01-9.32). A structural equation model found the intervention had moderate effects on couple communication, large effects on couple efficacy to take action around HIV, which in turn improved HIV prevention behaviors (CFI = 0.969; TLI = 0.955; RMSEA = 0.049). Strengthening couple communication and efficacy may help prevent the spread of HIV to infants or partners around the time of pregnancy.",2020,"In logistic regression, intervention condition couples had three-fold higher odds of perfect adherence (AOR = 3.07, 95% CI = 1.01-9.32).","['rural Kenya to explore couple-level adherence to HIV prevention\xa0behaviors', 'Pregnant women', 'Pregnant Women and Male Partners in Kenya']","['Home-Based Couples Intervention', 'standard care']","['HIV prevention behaviors', 'health education, relationship-building skills, and Couples HIV Testing and Counseling']","[{'cui': 'C0022558', 'cui_str': 'Republic of Kenya'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0682323', 'cui_str': 'Companion'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0018701'}, {'cui': 'C0439849', 'cui_str': 'Relationships (qualifier value)'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}]",96.0,0.0433479,"In logistic regression, intervention condition couples had three-fold higher odds of perfect adherence (AOR = 3.07, 95% CI = 1.01-9.32).","[{'ForeName': 'Abigail M', 'Initials': 'AM', 'LastName': 'Hatcher', 'Affiliation': 'Division of HIV/AIDS, Department of Medicine, University of California, 995 Potrero Avenue, Building 80, San Francisco, CA, 94110, USA. hatchera@globalhealth.ucsf.edu.'}, {'ForeName': 'Lynae', 'Initials': 'L', 'LastName': 'Darbes', 'Affiliation': 'Department of Health Behavior and Biological Sciences, School of Nursing, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Zachary', 'Initials': 'Z', 'LastName': 'Kwena', 'Affiliation': 'Centre for Microbiology Research, Kenya Medical Research Institute, Nairobi, Kenya.'}, {'ForeName': 'Pamela L', 'Initials': 'PL', 'LastName': 'Musoke', 'Affiliation': 'Department of Global Health and Obstetrics and Gynecology, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Anna Joy', 'Initials': 'AJ', 'LastName': 'Rogers', 'Affiliation': 'Department of Global Health and Obstetrics and Gynecology, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Owino', 'Affiliation': 'Centre for Microbiology Research, Kenya Medical Research Institute, Nairobi, Kenya.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Helova', 'Affiliation': 'Department of Health Care Organization and Policy, School of Public Health, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Jami L', 'Initials': 'JL', 'LastName': 'Anderson', 'Affiliation': 'Sparkman Center for Global Health, School of Public Health, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Oyaro', 'Affiliation': 'Research Care and Training Programme, Family AIDS Care and Educational Services, Kisumu, Kenya.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Bukusi', 'Affiliation': 'Centre for Microbiology Research, Kenya Medical Research Institute, Nairobi, Kenya.'}, {'ForeName': 'Janet M', 'Initials': 'JM', 'LastName': 'Turan', 'Affiliation': 'Department of Health Care Organization and Policy, School of Public Health, University of Alabama at Birmingham, Birmingham, AL, USA.'}]",AIDS and behavior,['10.1007/s10461-019-02774-4'] 984,29401177,ACUTE EFFECT OF CAFFEINE ON MACULAR MICROCIRCULATION IN HEALTHY SUBJECTS: An Optical Coherence Tomography Angiography Study.,"PURPOSE To evaluate the acute effects of caffeine on macular microvasculature using quantitative optical coherence tomography angiography analysis. METHODS Fifty-two healthy subjects aged 24 to 48 years were randomly divided into 2 groups: a control group, which received placebo, and a study group, which was subjected to caffeine. All participants underwent optical coherence tomography angiography at baseline and 1 hour after 200-mg oral caffeine intake in the study group and after oral placebo in the control group. Macular flow area, macular vessel density, and foveal avascular zone (FAZ) area were analyzed in both the groups. RESULTS The study group consisted of 14 men and 12 women with a mean age of 40.6 ± 8.9 years. The mean age of control group was 39.5 ± 9.4 years, which consisted of 13 men and 13 women. Baseline macular flow area, vessel density, and FAZ area measurements of the study and control groups showed no significant difference (P > 0.05). Oral caffeine intake caused a significant reduction in macular flow area (superficial, deep, and choriocapillaris) and vessel density (P < 0.05). However, there was no statistically significant difference in FAZ area after caffeine intake when compared with baseline measurements (P = 0.063). CONCLUSION We found a significant decrease in macular flow area (superficial, deep, and choriocapillaris) and vessel density after caffeine intake. Our findings are consistent with previous studies using other techniques. We believe that the results of this preliminary study will be useful in future studies about this topic.",2019,"Oral caffeine intake caused a significant reduction in macular flow area (superficial, deep, and choriocapillaris) and vessel density (P < 0.05).","['14 men and 12 women with a mean age of 40.6 ± 8.9 years', 'Fifty-two healthy subjects aged 24 to 48 years', 'The mean age of control group was 39.5 ± 9.4 years, which consisted of 13 men and 13 women']","['caffeine', 'optical coherence tomography angiography', 'placebo']","['Macular flow area, macular vessel density, and foveal avascular zone (FAZ) area', 'FAZ area', 'macular flow area (superficial, deep, and choriocapillaris) and vessel density', 'Baseline macular flow area, vessel density, and FAZ area measurements']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4319570', 'cui_str': 'Fifty-two'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C0920367', 'cui_str': 'Tomography, Optical Coherence'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0148346', 'cui_str': 'Vessel'}, {'cui': 'C0178587', 'cui_str': 'Mass to volume ratio'}, {'cui': 'C1275950', 'cui_str': 'Foveal avascular zone'}, {'cui': 'C0205124', 'cui_str': 'Superficial (qualifier value)'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0229143', 'cui_str': 'Structure of lamina choroidocapillaris'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}]",52.0,0.0430617,"Oral caffeine intake caused a significant reduction in macular flow area (superficial, deep, and choriocapillaris) and vessel density (P < 0.05).","[{'ForeName': 'Omer', 'Initials': 'O', 'LastName': 'Karti', 'Affiliation': 'Department of Ophthalmology, İzmir Katip Çelebi University Medical Faculty, Izmir, Turkey.'}, {'ForeName': 'Mehmet Ozgur', 'Initials': 'MO', 'LastName': 'Zengin', 'Affiliation': 'Department of Ophthalmology, İzmir Katip Çelebi University Medical Faculty, Izmir, Turkey.'}, {'ForeName': 'Suleyman Gokhan', 'Initials': 'SG', 'LastName': 'Kerci', 'Affiliation': 'Department of Ophthalmology, İzmir Katip Çelebi University Medical Faculty, Izmir, Turkey.'}, {'ForeName': 'Ziya', 'Initials': 'Z', 'LastName': 'Ayhan', 'Affiliation': 'Department of Ophthalmology, Dokuz Eylul University, Izmir, Turkey.'}, {'ForeName': 'Tuncay', 'Initials': 'T', 'LastName': 'Kusbeci', 'Affiliation': 'Department of Ophthalmology, İzmir Katip Çelebi University Medical Faculty, Izmir, Turkey.'}]","Retina (Philadelphia, Pa.)",['10.1097/IAE.0000000000002058'] 985,31770051,Comparison of immunogenicity between intradermal and intramuscular injections of repeated annual identical influenza virus strains post-pandemic (2011-2012) in COPD patients.,"We compared the antibody responses and persistence of the reduced-dose, 9 µg hemagglutinin (HA)/strain intradermal (ID) injection via the Mantoux technique and the 15 μg HA/strain intramuscular (IM) injection of the repeated annual identical trivalent, inactivated, split-virion vaccine 2011-2012 in chronic obstructive pulmonary disease (COPD) patients. Eighty patients were randomized to ID (n = 41) and IM (n = 39) groups. Four weeks post-vaccination, the antibody responses of the two groups were similar; those for influenza A(H1N1)pdm09 and influenza A(H3N2)-but not influenza B-met the criteria of the Committee for Proprietary Medicinal Products (CPMP). The antibody responses for influenza A(H1N1)pdm09 rapidly declined in both groups, especially with the ID injection, whereas those for influenza A(H3N2) maintained above the CPMP criteria throughout 12 months post-vaccination. The geometric mean titres for influenza A(H1N1)pdm09 persisted above the protective threshold (≥ 40) until 6 months post-vaccination in both the ID and IM groups. The seroprotection rates of the ID and IM groups were above 60% until 3 months and 6 months post-vaccination, respectively. In conclusion, the 9 μg HA/strain ID injection of vaccine 2011-2012 elicited antibody responses similar to the standard dose of 15 μg of the HA/strain IM injection at 4 weeks post-vaccination. However, the antibody responses for influenza A(H1N1)pdm09 rapidly declined, especially in the case of the ID injection, whereas they were comparable for influenza A(H3N2). Additional strategies for increasing vaccine durability should be considered, especially for new pandemic strains affecting elderly COPD patients.",2020,"The seroprotection rates of the ID and IM groups were above 60% until 3 months and 6 months post-vaccination, respectively.","['COPD patients', 'elderly COPD patients', '2011-2012 in chronic obstructive pulmonary disease (COPD) patients', 'Eighty patients']","['hemagglutinin (HA)/strain intradermal (ID) injection via the Mantoux technique and the 15\xa0μg HA/strain intramuscular (IM) injection of the repeated annual identical trivalent, inactivated, split-virion vaccine']","['seroprotection rates', 'geometric mean titres']","[{'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3816958', 'cui_str': 'Eighty'}]","[{'cui': 'C0018909', 'cui_str': 'Hemagglutinin'}, {'cui': 'C0021489', 'cui_str': 'Intradermal injection (procedure)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0080194', 'cui_str': 'Strains'}, {'cui': 'C0021492', 'cui_str': 'Intramuscular injection (procedure)'}, {'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}, {'cui': 'C0205280', 'cui_str': 'Identical (qualifier value)'}, {'cui': 'C0042760', 'cui_str': 'Viral Particles'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0475208', 'cui_str': 'TITR'}]",2012.0,0.0280828,"The seroprotection rates of the ID and IM groups were above 60% until 3 months and 6 months post-vaccination, respectively.","[{'ForeName': 'Benjamas', 'Initials': 'B', 'LastName': 'Chuaychoo', 'Affiliation': 'Division of Respiratory Disease and Tuberculosis, Department of Medicine, Faculty of Medicine Siriraj Hospital , Bangkok, Thailand.'}, {'ForeName': 'Uraiwan', 'Initials': 'U', 'LastName': 'Kositanont', 'Affiliation': 'Department of Microbiology, Faculty of Medicine Siriraj Hospital , Bangkok, Thailand.'}, {'ForeName': 'Parichat', 'Initials': 'P', 'LastName': 'Niyomthong', 'Affiliation': 'Division of Respiratory Disease and Tuberculosis, Department of Medicine, Faculty of Medicine Siriraj Hospital , Bangkok, Thailand.'}, {'ForeName': 'Nuttapol', 'Initials': 'N', 'LastName': 'Rittayamai', 'Affiliation': 'Division of Respiratory Disease and Tuberculosis, Department of Medicine, Faculty of Medicine Siriraj Hospital , Bangkok, Thailand.'}, {'ForeName': 'Sorachai', 'Initials': 'S', 'LastName': 'Srisuma', 'Affiliation': 'Department of Physiology, Faculty of Medicine Siriraj Hospital, Mahidol University , Bangkok, Thailand.'}, {'ForeName': 'Kanokwan', 'Initials': 'K', 'LastName': 'Rattanasaengloet', 'Affiliation': 'Division of Respiratory Disease and Tuberculosis, Department of Medicine, Faculty of Medicine Siriraj Hospital , Bangkok, Thailand.'}, {'ForeName': 'Walaiporn', 'Initials': 'W', 'LastName': 'Wongsrisakunkaew', 'Affiliation': 'Division of Respiratory Disease and Tuberculosis, Department of Medicine, Faculty of Medicine Siriraj Hospital , Bangkok, Thailand.'}, {'ForeName': 'Julalux', 'Initials': 'J', 'LastName': 'Thongam', 'Affiliation': 'Department of Physiology, Faculty of Medicine Siriraj Hospital, Mahidol University , Bangkok, Thailand.'}, {'ForeName': 'Thaweesak', 'Initials': 'T', 'LastName': 'Songserm', 'Affiliation': 'Department of Veterinary Pathology, Kamphaeng Saen, Kasetsart University , Nakhon Pathom, Thailand.'}]",Human vaccines & immunotherapeutics,['10.1080/21645515.2019.1692559'] 986,31769596,A randomized study showing improved skin quality and aesthetic appearance of dorsal hands after hyaluronic acid gel treatment in a Chinese population.,"BACKGROUND Patients are increasingly aware of the aesthetic appearance of aging hands. AIMS To evaluate efficacy and safety of a hyaluronic acid gel for improving skin quality in aged skin of the dorsal hand. METHODS This was a 15-month randomized, multi-center, evaluator-blinded, split-hand, no treatment-controlled study. Three treatments with hyaluronic acid gel were administered in the same hand in adult Chinese subjects with grade 2 or 3 (mild or moderate aging) on the Hand Grading Scale (HGS). The primary objective was to evaluate the difference at 3 months between treated and untreated hands, based on the blinded evaluator's HGS assessment. Secondary assessments included the Global Aesthetic Improvement Scale (GAIS), biophysical measurements (skin elasticity, skin roughness and hydration), and subject satisfaction. Safety was evaluated by incidence of adverse events. RESULTS A total of 100 subjects were enrolled. Clinically relevant differences in HGS favored HA gel (P < .0001). At 15 months, 87%-96% of treated hands were still improved according to GAIS (per evaluator and subject, respectively). Objective measures of skin quality improved, confirmed by evaluators and highly satisfied subjects. Treatment was well tolerated. CONCLUSIONS Hyaluronic acid treatment improved skin quality and reduced the aging appearance of the hand, with high subject satisfaction.",2020,Clinically relevant differences in HGS favored HA gel (P < .0001).,"['adult Chinese subjects with grade 2 or 3 (mild or moderate aging) on the Hand Grading Scale (HGS', 'aged skin of the dorsal hand', 'a Chinese population', '100 subjects were enrolled']","['Hyaluronic acid', 'hyaluronic acid gel']","['Global Aesthetic Improvement Scale (GAIS), biophysical measurements (skin elasticity, skin roughness and hydration), and subject satisfaction', 'skin quality and aesthetic appearance of dorsal hands', 'skin quality', 'tolerated']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0222045'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0230372', 'cui_str': 'Structure of dorsum of hand'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}]","[{'cui': 'C1141990', 'cui_str': 'Hyaluronic acid'}, {'cui': 'C0017243', 'cui_str': 'Gel (basic dose form)'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0014901', 'cui_str': 'Esthetics'}, {'cui': 'C0222045'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0423761', 'cui_str': 'Skin elasticity (observable entity)'}, {'cui': 'C0859038', 'cui_str': 'Skin roughness'}, {'cui': 'C1321013', 'cui_str': 'Hydration'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0700364', 'cui_str': 'Appearances (qualifier value)'}, {'cui': 'C0230372', 'cui_str': 'Structure of dorsum of hand'}]",100.0,0.0514832,Clinically relevant differences in HGS favored HA gel (P < .0001).,"[{'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'Peking University First Hospital, Beijing, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Tian', 'Affiliation': 'Air Force General Hospital PLA, Beijing, China.'}, {'ForeName': 'Jinhua', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'Fudan University Huashan Hospital, Shanghai, China.'}, {'ForeName': 'Shaomin', 'Initials': 'S', 'LastName': 'Zhong', 'Affiliation': 'Peking University First Hospital, Beijing, China.'}, {'ForeName': 'Ruiyan', 'Initials': 'R', 'LastName': 'Wang', 'Affiliation': 'Air Force General Hospital PLA, Beijing, China.'}, {'ForeName': 'Wenyu', 'Initials': 'W', 'LastName': 'Wu', 'Affiliation': 'Fudan University Huashan Hospital, Shanghai, China.'}]",Journal of cosmetic dermatology,['10.1111/jocd.13221'] 987,31070386,A randomized clinical trial evaluating the efficacy of a brief alcohol intervention supplemented with a substance-free activity session or relaxation training.,"OBJECTIVE Behavioral economic theory suggests that a reduction in alcohol use is most likely when there is an increase in rewarding substance-free activities. Anxiety has also been linked to heavy drinking, and strategies to reduce anxiety may enhance alcohol interventions. The goal of this 2-site randomized controlled clinical trial was to evaluate the efficacy of a brief alcohol intervention that was supplemented with either a behavioral economic substance-free activity session (SFAS) or a relaxation training (Relaxation training [RT]) session. METHOD Participants were 393 college students (61% female, mean age = 18.77 years) who reported 2 or more past-month heavy drinking episodes. Participants were randomized to 1 of 3 conditions: (a) assessment; (b) alcohol brief motivational intervention (BMI) plus SFAS; or (c) BMI plus RT. Both treatment conditions included 2 in-person sessions plus a phone booster session. Outcomes were evaluated 1-, 6-, 12-, and 16-months postintervention. RESULTS Generalized linear mixed models indicated that the combination of a BMI plus either the SFAS or RT was associated with significant reductions in alcohol use and problems across the 16-month follow-up compared with assessment only. There were no significant differences between the two active treatment conditions. Changes in proportional reinforcement from substance-related activities, and protective behavioral strategies mediated treatment effects. CONCLUSION Two-session (plus booster) interventions that combine BMI and either substance-free activity enhancement or RT can result in enduring reductions in alcohol misuse among college drinkers. (PsycINFO Database Record (c) 2019 APA, all rights reserved).",2019,There were no significant differences between the two active treatment conditions.,"['Participants were 393 college students (61% female, mean age = 18.77 years) who reported 2 or more past-month heavy drinking episodes', 'college drinkers']","['behavioral economic substance-free activity session (SFAS) or a relaxation training (Relaxation training [RT]) session', 'alcohol intervention supplemented with a substance-free activity session or relaxation training', 'alcohol brief motivational intervention (BMI) plus SFAS; or (c) BMI plus RT', 'alcohol intervention']",[],"[{'cui': 'C4517754', 'cui_str': 'Three hundred and ninety-three'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C1444637', 'cui_str': 'In the past'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0439539', 'cui_str': 'Heavy sensation quality'}, {'cui': 'C0556342', 'cui_str': 'Drinking episode (finding)'}]","[{'cui': 'C1510587', 'cui_str': 'Economics, Behavioral'}, {'cui': 'C0439861', 'cui_str': 'Substance (substance)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0282333', 'cui_str': 'Relaxation Therapy'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]",[],,0.0256474,There were no significant differences between the two active treatment conditions.,"[{'ForeName': 'James G', 'Initials': 'JG', 'LastName': 'Murphy', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Ashley A', 'Initials': 'AA', 'LastName': 'Dennhardt', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Matthew P', 'Initials': 'MP', 'LastName': 'Martens', 'Affiliation': 'Department of Educational, School, and Counseling Psychology.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Borsari', 'Affiliation': 'Mental Health Service.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Witkiewitz', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Lidia Z', 'Initials': 'LZ', 'LastName': 'Meshesha', 'Affiliation': 'Center for Alcohol and Addiction Studies.'}]",Journal of consulting and clinical psychology,['10.1037/ccp0000412'] 988,31215805,Urine citrate excretion identifies changes in acid retention as eGFR declines in patients with chronic kidney disease.,"Previous studies have shown that acid (H + ) retention in patients with chronic kidney disease (CKD) but without metabolic acidosis increases as the estimated glomerular filtration rate (eGFR) decreases over time. The present study examined whether changes in urine excretion of the pH-sensitive metabolite citrate predicted changes in H + retention over time in similar patients with CKD that were followed for 10 yr. We randomized 120 CKD2 nondiabetic, hypertension-associated nephropathy patients with plasma total CO 2 of >24 mM to receive 0.5 meq·kg body wt -1 ·day -1 NaHCO 3 ([Formula: see text]; n = 40), 0.5 meq·kg body wt -1 ·day -1 NaCl (NaCl; n = 40), or usual care (UC; n = 40). We assessed eGFR (CKD-EPI) and H + retention by comparing the observed with expected plasma total CO 2 increase 2 h after an oral NaHCO 3 bolus (0.5 meq/kg body wt). Although 10 yr versus baseline eGFR was lower for each group, 10-yr eGFR was higher ( P < 0.01) in [Formula: see text] (59.6 ± 4.8 ml·min -1 ·1.73 m -2 ) than NaCl and UC (52.1 ± 5.9 and 52.3 ± 4.1 ml·min -1 ·1.73 m -2 , respectively) groups. Less eGFR preservation was associated with higher 10-yr versus baseline H + retention in the NaCl group (26.5 ± 13.1 vs. 18.2 ± 15.3 mmol, P < 0.01) and UC group (24.8 ± 11.3 vs. 17.7 ± 10.9 mmol, P < 0.01) and with lower 10-yr versus baseline 8-h urine citrate excretion (U citrate V) for the NaCl group (162 ± 47 vs. 196 ± 52 mg, respectively, P < 0.01) and UC group (153 ± 41 vs. 186 ± 42 mg, respectively, P < 0.01). Conversely, better eGFR preservation in the [Formula: see text] group was associated with no differences in 10-yr versus baseline H + retention (14.2 ±13.5 vs. 16.1 ± 15.1 mmol, P = 1.00) or U citrate V (212 ± 45 vs. 203 ± 49 mg, respectively, P = 0.74). An overall generalized linear model for repeated measures showed that U citrate V predicted H + retention ( P < 0.01). Less eGFR preservation in patients with CKD2 without metabolic acidosis was associated with increased H + retention that was predicted by decreased U citrate V.",2019,An overall generalized linear model for repeated measures showed that U citrate V predicted H + retention (p<0.01).,"['patients with chronic kidney disease (CKD) stage 2 eGFR (60-89 ml ', '120 CKD 2 non-diabetic, hypertension-associated nephropathy patients with plasma total CO 2 (PTCO 2 ) > 24 mM to receive 0.5 mEq/kg bw/day NaHCO 3 (HCO 3 - , n=40), 0.5 mEq/kg bw/day NaCl (NaCl, n=40), or Usual Care (UC, n=40', 'patients with chronic kidney disease']",['min-1.73m-2'],"['acid (H + ) retention', 'eGFR preservation', '10-year eGFR', 'eGFR (CKD-EPI) and H + retention']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2316786', 'cui_str': 'CKD stage 2'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0022658', 'cui_str': 'Kidney Diseases'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C1300572', 'cui_str': 'mEq/kg'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0037494', 'cui_str': 'Sodium Chloride'}, {'cui': 'C1561643', 'cui_str': 'Chronic Kidney Diseases'}]","[{'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}]","[{'cui': 'C0001128', 'cui_str': 'Acids'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0267963', 'cui_str': 'Pancreatic Insufficiency'}]",120.0,0.0296586,An overall generalized linear model for repeated measures showed that U citrate V predicted H + retention (p<0.01).,"[{'ForeName': 'Nimrit', 'Initials': 'N', 'LastName': 'Goraya', 'Affiliation': 'Baylor Scott and White Health Department of Internal Medicine, Temple, Texas.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Simoni', 'Affiliation': 'Department of Surgery, Texas Tech University Health Sciences Center, Lubbock, Texas.'}, {'ForeName': 'Lauren N', 'Initials': 'LN', 'LastName': 'Sager', 'Affiliation': 'Baylor Scott and White Health Department of Biostatistics, Temple, Texas.'}, {'ForeName': 'Abdullah', 'Initials': 'A', 'LastName': 'Mamun', 'Affiliation': 'Baylor Scott and White Health and Wellness Center, Dallas, Texas.'}, {'ForeName': 'Nicolaos E', 'Initials': 'NE', 'LastName': 'Madias', 'Affiliation': ""School of Medicine, Department of Medicine, St. Elizabeth's Medical Center and Tufts University, Boston, Massachusetts.""}, {'ForeName': 'Donald E', 'Initials': 'DE', 'LastName': 'Wesson', 'Affiliation': 'Baylor Scott and White Health Department of Internal Medicine, Dallas, Texas.'}]",American journal of physiology. Renal physiology,['10.1152/ajprenal.00044.2019'] 989,31215985,Comparison of Outcomes After Transcatheter vs Surgical Aortic Valve Replacement Among Patients at Intermediate Operative Risk With a History of Coronary Artery Bypass Graft Surgery: A Post Hoc Analysis of the SURTAVI Randomized Clinical Trial.,"Importance Surgical aortic valve replacement (SAVR) has increased risk for patients with aortic stenosis (AS) and a history of coronary artery bypass graft (CABG) surgery. Transcatheter aortic valve replacement (TAVR) may be an alternative. Objective To compare TAVR with SAVR outcomes in patients at intermediate operative risk with prior CABG surgery. Design, Setting, and Participants In this post hoc analysis of the Surgical Replacement and Transcatheter Aortic Valve Implantation (SURTAVI) noninferiority randomized clinical trial, patients with severe, symptomatic AS at intermediate operative risk were enrolled from 87 centers across the United States, Europe, and Canada from June 2012 to June 2016 and followed-up with up to July 2017. Those with a history of CABG surgery were considered for analysis. Data were analyzed from September to December 2017. Interventions A total of 1746 patients were enrolled and randomized 1:1 to self-expanding TAVR or SAVR. An implant was attempted in 1660 patients, of whom 273 had prior CABG surgery, including 136 who underwent attempted TAVR and 137 who underwent attempted SAVR. Main Outcomes and Measures The primary outcome was all-cause mortality or disabling stroke at 1-year follow-up. Efficacy outcomes included quality of life, measured using the Kansas City Cardiomyopathy Questionnaire at 30 days, 6 months, and 1 year, and distance walked in 6 minutes, measured using the 6-minute walk test at 30 days and 1 year. Results Of the 136 patients in the TAVR cohort, 111 (81.6%) were male, and the mean (SD) age was 76.9 (6.5) years; of the 137 in the SAVR cohort, 117 (85.4%) were male, and the mean (SD) age was 76.6 (6.5) years. The mean (SD) Society of Thoracic Surgeons Predicted Risk of Mortality score was 5.0% (1.6%) in the TAVR cohort and 5.2% (1.7%) in the SAVR cohort. All-cause mortality or disabling stroke at 1-year follow-up was 8.9% (95% CI, 5.2-15.2) in the TAVR cohort and 6.7% (95% CI, 3.5-12.8) in the SAVR cohort (log-rank P = .53). Compared with patients receiving SAVR, the mean (SD) Kansas City Cardiomyopathy Questionnaire summary score was significantly better among patients receiving TAVR at 30 days (81.4 [19.2] vs 69.7 [22.6]; P < .001); treatments were similar at 1 year (85.7 [14.6] vs 82.8 [18.4]; P = .19). Compared with patients in the SAVR cohort, those in the TAVR cohort showed greater mean (SD) improvement in distance walked at 1 year (48.3 [120.6] m vs 16.8 [88.7] m; P = .04). Conclusions and Relevance Both TAVR and SAVR were safe for intermediate-risk patients with AS and prior CABG surgery. The transcatheter approach facilitated faster improvement in quality of life and better exercise capacity at 1-year follow-up. Trial Registration ClinicalTrials.gov identifier: NCT01586910.",2019,"The transcatheter approach facilitated faster improvement in quality of life and better exercise capacity at 1-year follow-up. ","['1660 patients, of whom 273 had prior CABG surgery, including 136 who underwent attempted TAVR and 137 who underwent attempted SAVR', 'Patients at Intermediate Operative Risk With a History of Coronary Artery Bypass Graft Surgery', 'patients at intermediate operative risk with prior CABG surgery', 'A total of 1746 patients', '136 patients in the TAVR cohort, 111 (81.6%) were male, and the mean (SD) age was 76.9 (6.5) years; of the 137 in the SAVR cohort, 117 (85.4%) were male, and the mean (SD) age was 76.6 (6.5) years', 'patients with aortic stenosis (AS) and a history of coronary artery bypass graft (CABG) surgery', 'patients with severe, symptomatic AS at intermediate operative risk were enrolled from 87 centers across the United States, Europe, and Canada from June 2012 to June 2016 and followed-up with up to July 2017']","['Transcatheter vs Surgical Aortic Valve Replacement', 'Transcatheter aortic valve replacement (TAVR', 'Surgical Replacement and Transcatheter Aortic Valve Implantation', 'Surgical aortic valve replacement (SAVR', 'self-expanding TAVR or SAVR', 'TAVR and SAVR']","['quality of life and better exercise capacity', 'mean (SD) Society of Thoracic Surgeons Predicted Risk of Mortality score', 'mean (SD) improvement in distance walked', 'cause mortality or disabling stroke', 'mean (SD) Kansas City Cardiomyopathy Questionnaire summary score', 'quality of life, measured using the Kansas City Cardiomyopathy Questionnaire at 30 days, 6 months, and 1 year, and distance walked in 6 minutes, measured using the 6-minute walk test at 30 days and 1 year', 'mortality or disabling stroke']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0010055', 'cui_str': 'Coronary Artery Bypass Grafting'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C4517568', 'cui_str': 'One hundred and thirty-six'}, {'cui': 'C4517569', 'cui_str': 'One hundred and thirty-seven'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4517538', 'cui_str': '111 (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3844007', 'cui_str': '6.5'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0003507', 'cui_str': 'Aortic Stenosis'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]","[{'cui': 'C0442343', 'cui_str': 'Transcatheter approach (qualifier value)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0003506', 'cui_str': 'Replacement of aortic valve (procedure)'}, {'cui': 'C2711836', 'cui_str': 'TAVR - Transcatheter aortic valve replacement'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0205229', 'cui_str': 'Expanding (qualifier value)'}]","[{'cui': 'C0034380'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0278626', 'cui_str': 'Thoracic surgeon (occupation)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0878544', 'cui_str': 'Cardiomyopathies'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0430515', 'cui_str': '6-Minute Walk Test'}]",1746.0,0.172768,"The transcatheter approach facilitated faster improvement in quality of life and better exercise capacity at 1-year follow-up. ","[{'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Reardon', 'Affiliation': 'Houston Methodist DeBakey Heart and Vascular Center, Houston, Texas.'}, {'ForeName': 'Robin H', 'Initials': 'RH', 'LastName': 'Heijmen', 'Affiliation': 'St Antonius Hospital, Nieuwegein, the Netherlands.'}, {'ForeName': 'Nicolas M', 'Initials': 'NM', 'LastName': 'Van Mieghem', 'Affiliation': 'Erasmus University Medical Center, Rotterdam, the Netherlands.'}, {'ForeName': 'Mathew R', 'Initials': 'MR', 'LastName': 'Williams', 'Affiliation': 'NYU Langone Medical Center, New York, New York.'}, {'ForeName': 'Steven J', 'Initials': 'SJ', 'LastName': 'Yakubov', 'Affiliation': 'OhioHeath Riverside Methodist Hospital, Columbus, Ohio.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Watson', 'Affiliation': 'OhioHeath Riverside Methodist Hospital, Columbus, Ohio.'}, {'ForeName': 'Neal S', 'Initials': 'NS', 'LastName': 'Kleiman', 'Affiliation': 'Houston Methodist DeBakey Heart and Vascular Center, Houston, Texas.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Conte', 'Affiliation': 'The Johns Hopkins University, Baltimore, Maryland.'}, {'ForeName': 'Atul', 'Initials': 'A', 'LastName': 'Chawla', 'Affiliation': 'Iowa Heart Center, Des Moines.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Hockmuth', 'Affiliation': 'Iowa Heart Center, Des Moines.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Petrossian', 'Affiliation': 'St Francis Hospital, Roslyn, New York.'}, {'ForeName': 'Newell', 'Initials': 'N', 'LastName': 'Robinson', 'Affiliation': 'St Francis Hospital, Roslyn, New York.'}, {'ForeName': 'A Pieter', 'Initials': 'AP', 'LastName': 'Kappetein', 'Affiliation': 'Medtronic, Minneapolis, Minnesota.'}, {'ForeName': 'Shuzhen', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'Medtronic, Minneapolis, Minnesota.'}, {'ForeName': 'Jeffrey J', 'Initials': 'JJ', 'LastName': 'Popma', 'Affiliation': 'Beth Israel Deaconess Medical Center, Boston, Massachusetts.'}]",JAMA cardiology,['10.1001/jamacardio.2019.1856'] 990,31854193,The Effect of 20-Minute Mindful Breathing on the Perception of Suffering and Changes in Bispectral Index Score (BIS) in Palliative Care Informal Caregivers: A Randomized Controlled Study.,"Informal caregivers are at risk of being overwhelmed by various sources of suffering while caring for their significant others. It is, therefore, important for caregivers to take care of themselves. In the self-care context, mindfulness has the potential to reduce caregiver suffering. We studied the effect of a single session of 20-minute mindful breathing on the perceived level of suffering, together with the changes in bispectral index score (BIS) among palliative care informal caregivers. This was a randomized controlled study conducted at the University of Malaya Medical Centre, Malaysia. Forty adult palliative care informal caregivers were recruited and randomly assigned to either 20-minute mindful breathing or 20-minute supportive listening. The changes in perceived suffering and BIS were measured preintervention and postintervention. The reduction in suffering score in the intervention group was significantly more than the control group at minute 20 ( U = 124.0, n 1 = n 2 = 20, mean rank 1 = 24.30, mean rank 2 = 16.70, z = -2.095, P = .036). The reduction in BIS in the intervention group was also significantly greater than the control group at minute 20 ( U = 19.5, n 1 = n 2 = 20, mean rank 1 = 29.52, mean rank 2 = 11.48, z = -4.900, P < .0001). Twenty minutes of mindful breathing was more efficacious than 20 minutes of supportive listening in the reduction in suffering among palliative care informal caregivers.",2020,Twenty minutes of mindful breathing was more efficacious than 20 minutes of supportive listening in the reduction in suffering among palliative care informal caregivers.,"['suffering among palliative care informal caregivers', 'Palliative Care Informal Caregivers', 'University of Malaya Medical Centre, Malaysia', 'palliative care informal caregivers', 'Forty adult palliative care informal caregivers']","['20-Minute Mindful Breathing', '20-minute mindful breathing or 20-minute supportive listening', 'supportive listening']","['reduction in BIS', 'bispectral index score (BIS', 'reduction in suffering score', 'Perception of Suffering and Changes in Bispectral Index Score (BIS']","[{'cui': 'C0700049', 'cui_str': 'Palliative care'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0445531', 'cui_str': 'Malaya (qualifier value)'}, {'cui': 'C0565990', 'cui_str': 'Medical center (environment)'}, {'cui': 'C0024552', 'cui_str': 'Federation of Malaya'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0035203', 'cui_str': 'Breathing'}]","[{'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C1872096', 'cui_str': 'bis(phenylacetylarginine)'}, {'cui': 'C1301882', 'cui_str': 'Bispectral index'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0443172', 'cui_str': 'State changes'}]",40.0,0.048756,Twenty minutes of mindful breathing was more efficacious than 20 minutes of supportive listening in the reduction in suffering among palliative care informal caregivers.,"[{'ForeName': 'Seng Beng', 'Initials': 'SB', 'LastName': 'Tan', 'Affiliation': 'Department of Medicine, Faculty of Medicine, University of Malaya Medical Centre, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Hui Chi', 'Initials': 'HC', 'LastName': 'Ching', 'Affiliation': 'Department of Medicine, Faculty of Medicine, University of Malaya Medical Centre, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Yuik Ling', 'Initials': 'YL', 'LastName': 'Chia', 'Affiliation': 'Department of Medicine, Faculty of Medicine, University of Malaya Medical Centre, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Yee', 'Affiliation': 'Department of Psychological Medicine, Faculty of Medicine, University of Malaya Medical Centre, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Chong Guan', 'Initials': 'CG', 'LastName': 'Ng', 'Affiliation': 'Department of Psychological Medicine, Faculty of Medicine, University of Malaya Medical Centre, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Mohd Shahnaz Bin', 'Initials': 'MSB', 'LastName': 'Hasan', 'Affiliation': 'Department of Anaesthesiology, Faculty of Medicine, University of Malaya Medical Centre, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Kheng Seang', 'Initials': 'KS', 'LastName': 'Lim', 'Affiliation': 'Department of Medicine, Faculty of Medicine, University of Malaya Medical Centre, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Sherrini Bazir', 'Initials': 'SB', 'LastName': 'Ahmad', 'Affiliation': 'Department of Medicine, Faculty of Medicine, University of Malaya Medical Centre, Kuala Lumpur, Malaysia.'}, {'ForeName': 'David Paul', 'Initials': 'DP', 'LastName': 'Capelle', 'Affiliation': 'Department of Medicine, Faculty of Medicine, University of Malaya Medical Centre, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Ee Chin', 'Initials': 'EC', 'LastName': 'Loh', 'Affiliation': 'Department of Medicine, Faculty of Medicine, University of Malaya Medical Centre, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Chee Loong', 'Initials': 'CL', 'LastName': 'Lam', 'Affiliation': 'Department of Medicine, Faculty of Medicine, University of Malaya Medical Centre, Kuala Lumpur, Malaysia.'}]",The American journal of hospice & palliative care,['10.1177/1049909119894507'] 991,31394300,"Efficacy of adjunctive photodynamic therapy on the clinical periodontal, HbA1c and advanced glycation end product levels among mild to moderate chronic periodontal disease patients with type 2 diabetes mellitus: A randomized controlled clinical trial.","AIMS To evaluate the clinical periodontal, serum glycated haemoglobin (HbA1c) and levels of advanced glycation end-products (AGEs) in the gingival crevicular fluid (GCF) among patients with periodontitis and type 2 diabetes mellitus (DM) after photodynamic therapy (PDT) as an adjunct to full-mouth disinfection (FMD). MATERIALS AND METHODS Thirty type 2 DM patients with mild to moderate periodontitis were divided into two main groups: Group-A receiving adjunctive PDT with FMD and Group-B receiving FMD alone. Full-mouth plaque index (PI), bleeding on probing (BOP), probing depth (PD), attachment level (AL) were recorded. Serum HbA1c was assessed among all participants using a HbA1c analyser kit. Levels of AGEs in GCF were determined using enzyme-linked immunosorbent assay. Clinical periodontal and metabolic parameters were assessed at baseline, 3 months and 6 months. Differences were compared using the Friedman test within the groups for different time points. Kruskal-Wallis test with Bonferroni correction test was applied for intragroup and multiple comparisons, respectively. RESULTS All the clinical periodontal parameters showed significant reduction from baseline to 3 months (P < 0.05) and 6 months follow-up in both the groups (P < 0.01). Only PD showed statistically significant difference from baseline to 3 months in Group-A (P < 0.01). Mean percentage of HbA1c remained constant throughout the study period in both the groups. Mean level of AGEs significantly reduced in both the groups at all time-points. Mean AGEs level reduced slightly higher in Group-A compared to Group-B at 3 months follow-up. However, this difference was not statistically significant (P > 0.05). CONCLUSION No additional benefit was seen in the improvement of clinical periodontal parameters and systemic (HbA1c levels) outcomes with PDT except that a minor reduction in the levels of AGEs in the GCF was observed with PDT in the short term.",2019,All the clinical periodontal parameters showed significant reduction from baseline to 3 months (P < 0.05) and 6 months follow-up in both the groups (P < 0.01).,"['patients with periodontitis and type 2 diabetes mellitus (DM) after', 'Thirty type 2 DM patients with mild to moderate periodontitis', 'mild to moderate chronic periodontal disease patients with type 2 diabetes mellitus']","['adjunctive PDT with FMD and Group-B receiving FMD alone', 'photodynamic therapy (PDT', 'adjunctive photodynamic therapy']","['Full-mouth plaque index (PI), bleeding on probing (BOP), probing depth (PD), attachment level (AL', 'Serum HbA1c', 'Mean AGEs level', 'Clinical periodontal and metabolic parameters', 'clinical periodontal, HbA1c and advanced glycation end product levels', 'Mean level of AGEs', 'clinical periodontal parameters and systemic (HbA1c levels', 'clinical periodontal, serum glycated haemoglobin (HbA1c) and levels of advanced glycation end-products (AGEs', 'levels of AGEs', 'Levels of AGEs in GCF']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0031099', 'cui_str': 'Periodontitis'}, {'cui': 'C0011860', 'cui_str': 'Diabetes Mellitus, Type 2'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0266929', 'cui_str': 'Adult Periodontitis'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}]","[{'cui': 'C0044588', 'cui_str': 'PDT'}, {'cui': 'C0441836', 'cui_str': 'Group B (qualifier value)'}, {'cui': 'C0031740', 'cui_str': 'Photodynamic Therapy'}]","[{'cui': 'C0221732', 'cui_str': 'Mouth plaque'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C3179165', 'cui_str': 'Probe (methazole)'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0162574', 'cui_str': 'Advanced Glycation Endproducts'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0017853', 'cui_str': 'Hemoglobin, Glycosylated'}]",30.0,0.0402139,All the clinical periodontal parameters showed significant reduction from baseline to 3 months (P < 0.05) and 6 months follow-up in both the groups (P < 0.01).,"[{'ForeName': 'Sana', 'Initials': 'S', 'LastName': 'Mirza', 'Affiliation': 'Department of Oral Pathology, Faculty of Dentistry, Ziauddin University, Karachi, Pakistan. Electronic address: sana.mirza@zu.edu.pk.'}, {'ForeName': 'Aftab Ahmed', 'Initials': 'AA', 'LastName': 'Khan', 'Affiliation': 'Dental Biomaterials Research Chair, College of Applied Medical Sciences, King Saud University, Riyadh, Saudi Arabia.'}, {'ForeName': 'Abdulaziz Abdullah', 'Initials': 'AA', 'LastName': 'Al-Kheraif', 'Affiliation': 'Dental Biomaterials Research Chair, College of Applied Medical Sciences, King Saud University, Riyadh, Saudi Arabia; Dental Health Department, College of Applied Medical Sciences, King Saud University, Riyadh, Saudi Arabia.'}, {'ForeName': 'Sultan Zeb', 'Initials': 'SZ', 'LastName': 'Khan', 'Affiliation': 'Department of Clinical Pathophysiology, Graduate School of Tokyo Dental College, 2-9-18 Kanda-Misaki-cho, Chiyoda-Ku, Tokyo, 101-0061, Japan.'}, {'ForeName': 'Syed Saad', 'Initials': 'SS', 'LastName': 'Shafqat', 'Affiliation': 'Medilink Consultation Clinics, Karachi, Pakistan.'}]",Photodiagnosis and photodynamic therapy,['10.1016/j.pdpdt.2019.08.003'] 992,31785587,Kinetics of oxytocin effects on amygdala and striatal reactivity vary between women and men.,"Accumulating evidence suggests that intranasal oxytocin (OXT; 24 IU) reduces amygdala responses to fear-related stimuli in men, while exerting inverse effects in women. However, OXT enhances activity of the brain reward system in both sexes. Importantly, a crucial and still open question is whether there are sex-specific dose-response relationships for the amygdala and striatal regions. To address this question, a total of 90 healthy women participated in a double-blind, placebo-controlled crossover functional magnetic resonance imaging (fMRI) study and the results were compared with our previous findings from men. Participants were randomly assigned to three doses of OXT (6 IU, 12 IU, and 24 IU) and completed an emotional face recognition task including fearful and happy faces of varying emotional intensities. Across doses, OXT enhanced amygdala reactivity to low fearful faces compared to placebo and increased responses to happy faces in the dorsal striatum in women. While treatment effects on amygdala reactivity were evident at each given dose, the OXT effect on striatal responses to social stimuli was more pronounced with higher doses, but this dose-dependent effect did not survive correction for multiple comparisons. Importantly, OXT effects on amygdala and striatal activation significantly differed between sexes and striatal baseline sexual-dimorphic response patterns were diminished after administration of OXT. Our findings suggest that OXT increases the salience of social signals by strengthening the sensitivity for these signals in the amygdala and in the striatum in women, while OXT may primarily induce anxiolysis by reducing amygdala responses in men.",2020,"Across doses, OXT enhanced amygdala reactivity to low fearful faces compared to placebo and increased responses to happy faces in the dorsal striatum in women.","['90 healthy women participated in a double-blind', 'women and men']","['OXT', 'placebo-controlled crossover functional magnetic resonance imaging (fMRI', 'oxytocin', 'intranasal oxytocin (OXT', 'placebo', 'emotional face recognition task including fearful and happy faces of varying emotional intensities']","['amygdala reactivity', 'amygdala and striatal reactivity', 'OXT effects on amygdala and striatal activation']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0376335', 'cui_str': 'fMRI'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach (qualifier value)'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C0524637', 'cui_str': 'Recognition (Psychology)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0458278', 'cui_str': 'Fearful (qualifier value)'}, {'cui': 'C0018592', 'cui_str': 'Happinesses'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}]","[{'cui': 'C0002708', 'cui_str': 'Amygdaloid Body'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}]",90.0,0.234159,"Across doses, OXT enhanced amygdala reactivity to low fearful faces compared to placebo and increased responses to happy faces in the dorsal striatum in women.","[{'ForeName': 'Jana', 'Initials': 'J', 'LastName': 'Lieberz', 'Affiliation': 'Division of Medical Psychology, University of Bonn, 53105, Bonn, Germany.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Scheele', 'Affiliation': 'Division of Medical Psychology, University of Bonn, 53105, Bonn, Germany. Dirk-Scheele@gmx.de.'}, {'ForeName': 'Franny B', 'Initials': 'FB', 'LastName': 'Spengler', 'Affiliation': 'Institute for Psychology, University of Freiburg, 79104, Freiburg, Germany.'}, {'ForeName': 'Tatjana', 'Initials': 'T', 'LastName': 'Matheisen', 'Affiliation': 'Division of Medical Psychology, University of Bonn, 53105, Bonn, Germany.'}, {'ForeName': 'Lìa', 'Initials': 'L', 'LastName': 'Schneider', 'Affiliation': 'Division of Medical Psychology, University of Bonn, 53105, Bonn, Germany.'}, {'ForeName': 'Birgit', 'Initials': 'B', 'LastName': 'Stoffel-Wagner', 'Affiliation': 'Institute of Clinical Chemistry and Clinical Pharmacology, University of Bonn, 53105, Bonn, Germany.'}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Kinfe', 'Affiliation': 'Department of Neurosurgery, Division of Functional Neurosurgery and Stereotaxy, Friedrich-Alexander University (FAU) Erlangen-Nürnberg, 91054, Erlangen, Germany.'}, {'ForeName': 'René', 'Initials': 'R', 'LastName': 'Hurlemann', 'Affiliation': 'Division of Medical Psychology, University of Bonn, 53105, Bonn, Germany.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-019-0582-6'] 993,31748208,"Platelet rich plasma injection for acute Achilles tendon rupture: PATH-2 randomised, placebo controlled, superiority trial.","OBJECTIVE To determine whether an injection of platelet rich plasma improves outcomes after acute Achilles tendon rupture. DESIGN Randomised, placebo controlled, two arm, parallel group, participant and assessor masked, superiority trial. SETTING Secondary care trauma units across 19 hospitals in the United Kingdom's health service. PARTICIPANTS Recruitment commenced in July 2015 and follow-up was completed in March 2018. 230 adults aged 18 years and over were included, with acute Achilles tendon rupture presenting within 12 days of injury and managed with non-surgical treatment. Exclusions were injury at the insertion or musculotendinous junction, major leg injury or deformity, diabetes mellitus, platelet or haematological disorder, systemic corticosteroids, anticoagulation treatment, and other contraindicating conditions. INTERVENTIONS Participants were randomised 1:1 to platelet rich plasma (n=114) or placebo (dry needle; n=116) injection. All participants received standard rehabilitation care (ankle immobilisation followed by physiotherapy). MAIN OUTCOMES AND MEASURES Primary outcome was muscle tendon function at 24 weeks, measured objectively with the limb symmetry index (injured/uninjured×100) in maximal work done during the heel rise endurance test (an instrumented measure of repeated single leg heel rises until fatigue). Secondary outcomes included patient reported function (Achilles tendon rupture score), quality of life (short form 12 version 2®), pain (visual analogue scale), goal attainment (patient specific functional scale), and adverse events. A central laboratory analysed the quality and content of platelet rich plasma. Analyses were by modified intention to treat. RESULTS Participants were 46 years old on average, and 57 (25%) of 230 were female. At 24 weeks, 202 (88%) participants completed the heel rise endurance test and 216 (94%) the patient reported outcomes. The platelet rich plasma was of good quality, with expected growth factor content. No difference was detected in muscle tendon function between participants receiving platelet rich plasma injections and those receiving placebo injections (limb symmetry index, mean 34.7% (standard deviation 17.7%) v 38.5% (22.8%); adjusted mean difference -3.9% (95% confidence interval -10.5% to 2.7%)) or in any secondary outcomes or adverse event rates. Complier average causal effect analyses gave similar findings. CONCLUSIONS There is no evidence to indicate that injections of platelet rich plasma can improve objective muscle tendon function, patient reported function, or quality of life after acute Achilles tendon rupture compared with placebo, or that they offer any patient benefit. TRIAL REGISTRATION ISRCTN54992179.",2019,"No difference was detected in muscle tendon function between participants receiving platelet rich plasma injections and those receiving placebo injections (limb symmetry index, mean 34.7% (standard deviation 17.7%) v 38.5% (22.8%); adjusted mean difference -3.9% (95% confidence interval -10.5% to 2.7%)) or in any secondary outcomes or adverse event rates.","['Recruitment commenced in July 2015 and follow-up was completed in March 2018', 'acute Achilles tendon rupture', '230 adults aged 18 years and over were included, with acute Achilles tendon rupture presenting within 12 days of injury and managed with non-surgical treatment', ""Secondary care trauma units across 19 hospitals in the United Kingdom's health service"", 'Participants were 46 years old on average, and 57 (25%) of 230 were female']","['Platelet rich plasma injection', 'platelet rich plasma', 'standard rehabilitation care (ankle immobilisation followed by physiotherapy', 'placebo', 'platelet rich plasma (n=114) or placebo (dry needle; n=116) injection']","['quality and content of platelet rich plasma', 'muscle tendon function', 'muscle tendon function at 24 weeks, measured objectively with the limb symmetry index (injured/uninjured×100) in maximal work done during the heel rise endurance test (an instrumented measure of repeated single leg heel rises until fatigue', 'heel rise endurance test', 'patient reported function (Achilles tendon rupture score), quality of life (short form 12 version 2®), pain (visual analogue scale), goal attainment (patient specific functional scale), and adverse events']","[{'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0151937', 'cui_str': 'Traumatic rupture of tendon'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0263970', 'cui_str': 'Rupture of Achilles tendon'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C2363849', 'cui_str': 'Non-surgical treatment'}, {'cui': 'C3494402', 'cui_str': 'Secondary Care'}, {'cui': 'C0040788', 'cui_str': 'Trauma Units'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0041700', 'cui_str': 'United Kingdom'}, {'cui': 'C0018747', 'cui_str': 'Health Services'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}]","[{'cui': 'C0370220', 'cui_str': 'Platelet rich plasma (substance)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation'}, {'cui': 'C0003086', 'cui_str': 'Regio tarsalis'}, {'cui': 'C0020944', 'cui_str': 'Immobilization'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0205222', 'cui_str': 'Dry (qualifier value)'}, {'cui': 'C0398296', 'cui_str': 'Cannulation of vascular fistula, graft or prosthetic device (procedure)'}]","[{'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C0370220', 'cui_str': 'Platelet rich plasma (substance)'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0039508', 'cui_str': 'Tendons'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0015385', 'cui_str': 'Limbs'}, {'cui': 'C0332516', 'cui_str': 'Symmetry'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0018870', 'cui_str': 'Heel'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0518031', 'cui_str': 'Endurance capacity'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C4551823', 'cui_str': 'instruments'}, {'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0151937', 'cui_str': 'Traumatic rupture of tendon'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0018017', 'cui_str': 'Goals'}, {'cui': 'C4304943', 'cui_str': 'Patient-Specific Functional Scale (assessment scale)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",230.0,0.706218,"No difference was detected in muscle tendon function between participants receiving platelet rich plasma injections and those receiving placebo injections (limb symmetry index, mean 34.7% (standard deviation 17.7%) v 38.5% (22.8%); adjusted mean difference -3.9% (95% confidence interval -10.5% to 2.7%)) or in any secondary outcomes or adverse event rates.","[{'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Keene', 'Affiliation': 'Kadoorie Research Centre, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK david.keene@ndorms.ox.ac.uk.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Alsousou', 'Affiliation': 'Institute of Translational Medicine, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Harrison', 'Affiliation': 'Institute of Inflammation and Ageing, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Philippa', 'Initials': 'P', 'LastName': 'Hulley', 'Affiliation': 'Botnar Research Centre, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Wagland', 'Affiliation': 'Kadoorie Research Centre, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Scott R', 'Initials': 'SR', 'LastName': 'Parsons', 'Affiliation': 'Kadoorie Research Centre, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Jacqueline Y', 'Initials': 'JY', 'LastName': 'Thompson', 'Affiliation': 'Kadoorie Research Centre, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Heather M', 'Initials': 'HM', 'LastName': ""O'Connor"", 'Affiliation': 'Oxford Clinical Trials Research Unit, Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Michael Maia', 'Initials': 'MM', 'LastName': 'Schlüssel', 'Affiliation': 'Oxford Clinical Trials Research Unit, Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Susan J', 'Initials': 'SJ', 'LastName': 'Dutton', 'Affiliation': 'Oxford Clinical Trials Research Unit, Centre for Statistics in Medicine, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Sarah E', 'Initials': 'SE', 'LastName': 'Lamb', 'Affiliation': 'Kadoorie Research Centre, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Willett', 'Affiliation': 'Kadoorie Research Centre, Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ (Clinical research ed.),['10.1136/bmj.l6132'] 994,31591062,"Real-time artificial intelligence for detection of upper gastrointestinal cancer by endoscopy: a multicentre, case-control, diagnostic study.","BACKGROUND Upper gastrointestinal cancers (including oesophageal cancer and gastric cancer) are the most common cancers worldwide. Artificial intelligence platforms using deep learning algorithms have made remarkable progress in medical imaging but their application in upper gastrointestinal cancers has been limited. We aimed to develop and validate the Gastrointestinal Artificial Intelligence Diagnostic System (GRAIDS) for the diagnosis of upper gastrointestinal cancers through analysis of imaging data from clinical endoscopies. METHODS This multicentre, case-control, diagnostic study was done in six hospitals of different tiers (ie, municipal, provincial, and national) in China. The images of consecutive participants, aged 18 years or older, who had not had a previous endoscopy were retrieved from all participating hospitals. All patients with upper gastrointestinal cancer lesions (including oesophageal cancer and gastric cancer) that were histologically proven malignancies were eligible for this study. Only images with standard white light were deemed eligible. The images from Sun Yat-sen University Cancer Center were randomly assigned (8:1:1) to the training and intrinsic verification datasets for developing GRAIDS, and the internal validation dataset for evaluating the performance of GRAIDS. Its diagnostic performance was evaluated using an internal and prospective validation set from Sun Yat-sen University Cancer Center (a national hospital) and additional external validation sets from five primary care hospitals. The performance of GRAIDS was also compared with endoscopists with three degrees of expertise: expert, competent, and trainee. The diagnostic accuracy, sensitivity, specificity, positive predictive value, and negative predictive value of GRAIDS and endoscopists for the identification of cancerous lesions were evaluated by calculating the 95% CIs using the Clopper-Pearson method. FINDINGS 1 036 496 endoscopy images from 84 424 individuals were used to develop and test GRAIDS. The diagnostic accuracy in identifying upper gastrointestinal cancers was 0·955 (95% CI 0·952-0·957) in the internal validation set, 0·927 (0·925-0·929) in the prospective set, and ranged from 0·915 (0·913-0·917) to 0·977 (0·977-0·978) in the five external validation sets. GRAIDS achieved diagnostic sensitivity similar to that of the expert endoscopist (0·942 [95% CI 0·924-0·957] vs 0·945 [0·927-0·959]; p=0·692) and superior sensitivity compared with competent (0·858 [0·832-0·880], p<0·0001) and trainee (0·722 [0·691-0·752], p<0·0001) endoscopists. The positive predictive value was 0·814 (95% CI 0·788-0·838) for GRAIDS, 0·932 (0·913-0·948) for the expert endoscopist, 0·974 (0·960-0·984) for the competent endoscopist, and 0·824 (0·795-0·850) for the trainee endoscopist. The negative predictive value was 0·978 (95% CI 0·971-0·984) for GRAIDS, 0·980 (0·974-0·985) for the expert endoscopist, 0·951 (0·942-0·959) for the competent endoscopist, and 0·904 (0·893-0·916) for the trainee endoscopist. INTERPRETATION GRAIDS achieved high diagnostic accuracy in detecting upper gastrointestinal cancers, with sensitivity similar to that of expert endoscopists and was superior to that of non-expert endoscopists. This system could assist community-based hospitals in improving their effectiveness in upper gastrointestinal cancer diagnoses. FUNDING The National Key R&D Program of China, the Natural Science Foundation of Guangdong Province, the Science and Technology Program of Guangdong, the Science and Technology Program of Guangzhou, and the Fundamental Research Funds for the Central Universities.",2019,The positive predictive value was 0·814,"['consecutive participants, aged 18 years or older, who had not had a previous endoscopy were retrieved from all participating hospitals', '0·927-0·959', 'Sun Yat-sen University Cancer Center (a national hospital) and additional external validation sets from five primary care hospitals', 'Sun Yat-sen University Cancer Center', 'All patients with upper gastrointestinal cancer lesions (including oesophageal cancer and gastric cancer', '1\u2008036', '496 endoscopy images from 84\u2008424 individuals', 'six hospitals of different tiers (ie, municipal, provincial, and national) in China', 'Upper gastrointestinal cancers (including oesophageal cancer and gastric cancer']","['Gastrointestinal Artificial Intelligence Diagnostic System (GRAIDS', 'Real-time artificial intelligence']","['superior sensitivity', 'diagnostic sensitivity', 'diagnostic accuracy, sensitivity, specificity, positive predictive value, and negative predictive value of GRAIDS and endoscopists for the identification of cancerous lesions']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0038817', 'cui_str': 'Sunshine'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0205101', 'cui_str': 'External (qualifier value)'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0337952', 'cui_str': 'Primary care hospital (environment)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0685938', 'cui_str': 'Gastrointestinal Cancer'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0546837', 'cui_str': 'Cancer of Esophagus'}, {'cui': 'C0024623', 'cui_str': 'Cancer of Stomach'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}]","[{'cui': 'C0003916', 'cui_str': 'AI (Artificial Intelligence)'}, {'cui': 'C0348026', 'cui_str': 'Diagnostic'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C1632851', 'cui_str': 'Times'}]","[{'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0348026', 'cui_str': 'Diagnostic'}, {'cui': 'C0037791', 'cui_str': 'Specificity'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0020792', 'cui_str': 'Identification'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}]",,0.0356061,The positive predictive value was 0·814,"[{'ForeName': 'Huiyan', 'Initials': 'H', 'LastName': 'Luo', 'Affiliation': 'Department of Medical Oncology, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Guoliang', 'Initials': 'G', 'LastName': 'Xu', 'Affiliation': 'Department of Endoscopy, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Chaofeng', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'Artificial Intelligence Laboratory, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Longjun', 'Initials': 'L', 'LastName': 'He', 'Affiliation': 'Department of Endoscopy, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Linna', 'Initials': 'L', 'LastName': 'Luo', 'Affiliation': 'Department of Medical Oncology, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Zixian', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Department of Medical Oncology, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Bingzhong', 'Initials': 'B', 'LastName': 'Jing', 'Affiliation': 'Artificial Intelligence Laboratory, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Yishu', 'Initials': 'Y', 'LastName': 'Deng', 'Affiliation': 'Artificial Intelligence Laboratory, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Jin', 'Affiliation': 'Department of Medical Oncology, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Yin', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Endoscopy, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Li', 'Affiliation': 'Artificial Intelligence Laboratory, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Wencheng', 'Initials': 'W', 'LastName': 'Tan', 'Affiliation': 'Department of Endoscopy, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Caisheng', 'Initials': 'C', 'LastName': 'He', 'Affiliation': 'Artificial Intelligence Laboratory, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Sharvesh Raj', 'Initials': 'SR', 'LastName': 'Seeruttun', 'Affiliation': 'Department of Gastric Surgery, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Qiubao', 'Initials': 'Q', 'LastName': 'Wu', 'Affiliation': 'Department of Endoscopy, Jiangxi Cancer Hospital, Nanchang, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Huang', 'Affiliation': 'Department of Endoscopy, Jiangxi Cancer Hospital, Nanchang, China.'}, {'ForeName': 'De-Wang', 'Initials': 'DW', 'LastName': 'Huang', 'Affiliation': 'Department of Digestive Internal, Wuzhou Red Cross Hospital, Wuzhou, China.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Chen', 'Affiliation': ""Department of Digestive Internal, The North Guangdong People's Hospital, Shaoguan, China.""}, {'ForeName': 'Shao-Bin', 'Initials': 'SB', 'LastName': 'Lin', 'Affiliation': ""Department of Digestive Internal, Puning People's Hospital, Puning, China.""}, {'ForeName': 'Qin-Ming', 'Initials': 'QM', 'LastName': 'Chen', 'Affiliation': ""Department of Digestive Internal, Puning People's Hospital, Puning, China.""}, {'ForeName': 'Chu-Ming', 'Initials': 'CM', 'LastName': 'Yuan', 'Affiliation': ""Department of Digestive Internal, Jieyang People's Hospital, Jieyang, China.""}, {'ForeName': 'Hai-Xin', 'Initials': 'HX', 'LastName': 'Chen', 'Affiliation': ""Department of Digestive Internal, Jieyang People's Hospital, Jieyang, China.""}, {'ForeName': 'Heng-Ying', 'Initials': 'HY', 'LastName': 'Pu', 'Affiliation': 'Medical Administration Department, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Zhou', 'Affiliation': 'Medical Administration Department, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'He', 'Affiliation': 'Medical Administration Department, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Rui-Hua', 'Initials': 'RH', 'LastName': 'Xu', 'Affiliation': 'Department of Medical Oncology, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Sun Yat-sen University Cancer Center, Guangzhou, China. Electronic address: xurh@sysucc.org.cn.'}]",The Lancet. Oncology,['10.1016/S1470-2045(19)30637-0'] 995,31793418,The Effectiveness of Topical Cannabidiol Oil in Symptomatic Relief of Peripheral Neuropathy of the Lower Extremities.,"BACKGROUND Peripheral neuropathy can significantly impact the quality of life for those who are affected, as therapies from the current treatment algorithm often fail to deliver adequate symptom relief. There has, however, been an increasing body of evidence for the use of cannabinoids in the treatment of chronic, noncancer pain. The efficacy of a topically delivered cannabidiol (CBD) oil in the management of neuropathic pain was examined in this four-week, randomized and placebocontrolled trial. METHODS In total, 29 patients with symptomatic peripheral neuropathy were recruited and enrolled. 15 patients were randomized to the CBD group with the treatment product containing 250 mg CBD/3 fl. oz, and 14 patients were randomized to the placebo group. After four weeks, the placebo group was allowed to crossover into the treatment group. The Neuropathic Pain Scale (NPS) was administered biweekly to assess the mean change from baseline to the end of the treatment period. RESULTS The study population included 62.1% males and 37.9% females with a mean age of 68 years. There was a statistically significant reduction in intense pain, sharp pain, cold and itchy sensations in the CBD group when compared to the placebo group. No adverse events were reported in this study. CONCLUSION Our findings demonstrate that the transdermal application of CBD oil can achieve significant improvement in pain and other disturbing sensations in patients with peripheral neuropathy. The treatment product was well tolerated and may provide a more effective alternative compared to other current therapies in the treatment of peripheral neuropathy.",2020,"There was a statistically significant reduction in intense pain, sharp pain, cold and itchy sensations in the CBD group when compared to the placebo group.","['patients with peripheral neuropathy', 'Symptomatic Relief of Peripheral Neuropathy of the Lower Extremities', 'The study population included 62.1% males and 37.9% females with a mean age of 68 years', 'In total 29 patients with symptomatic peripheral neuropathy were recruited and enrolled', '15 patients']","['CBD', 'topically delivered cannabidiol (CBD) oil', 'placebo', 'CBD oil', 'Topical Cannabidiol Oil']","['neuropathic pain scale (NPS', 'intense pain, sharp pain, cold and itchy sensations', 'adverse events', 'pain and other disturbing sensations', 'neuropathic pain']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0031117', 'cui_str': 'PNS (Peripheral Nervous System) Diseases'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C1301676', 'cui_str': 'Relieves (qualifier value)'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]","[{'cui': 'C0006863', 'cui_str': '1,3-Benzenediol, 2-(3-methyl-6-(1-methylethenyl)-2-cyclohexen-1-yl)-5-pentyl-, (1R-trans)-'}, {'cui': 'C0028908', 'cui_str': 'Oils'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}]","[{'cui': 'C0027796', 'cui_str': 'Neurodynia'}, {'cui': 'C0222045'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0455270', 'cui_str': 'Sharp pain (finding)'}, {'cui': 'C0009443', 'cui_str': 'Common Cold'}, {'cui': 'C0033774', 'cui_str': 'Pruritis'}, {'cui': 'C0036658', 'cui_str': 'Sensory Function'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.0634657,"There was a statistically significant reduction in intense pain, sharp pain, cold and itchy sensations in the CBD group when compared to the placebo group.","[{'ForeName': 'Dixon H', 'Initials': 'DH', 'LastName': 'Xu', 'Affiliation': 'PGY-2, Department of Podiatric Medicine and Surgery, Scripps Mercy Hospital, San Diego, CA 92103, United States.'}, {'ForeName': 'Benjamin D', 'Initials': 'BD', 'LastName': 'Cullen', 'Affiliation': 'Podiatric Surgery Section Chief, Scripps Mercy Hospital, 4077 Fifth Ave, MER35, San Diego, CA, 92103, United States.'}, {'ForeName': 'Meng', 'Initials': 'M', 'LastName': 'Tang', 'Affiliation': 'Department of Microbiology, Immunology & Pathology, Des Moines University, Des Moines, IA, 50312, United States.'}, {'ForeName': 'Yujiang', 'Initials': 'Y', 'LastName': 'Fang', 'Affiliation': 'Department of Microbiology, Immunology & Pathology, Des Moines University, Des Moines, IA, 50312, United States.'}]",Current pharmaceutical biotechnology,['10.2174/1389201020666191202111534'] 996,31553222,Clinical Outcomes Before and After Complete Everolimus-Eluting Bioresorbable Scaffold Resorption: Five-Year Follow-Up From the ABSORB III Trial.,"BACKGROUND The Absorb everolimus-eluting bioresorbable vascular scaffold (BVS) provides early drug delivery and mechanical support similar to those of metallic drug-eluting stents, followed by complete resorption in ≈3 years with recovery of vascular structure and function. The ABSORB III trial demonstrated noninferior rates of target lesion failure (cardiac death, target vessel myocardial infarction, or ischemia-driven target lesion revascularization) at 1 year with BVS compared with cobalt chromium everolimus-eluting stents. Between 1 and 3 years and cumulative to 3 years, adverse event rates (particularly target vessel myocardial infarction and scaffold thrombosis) were increased after BVS. We sought to assess clinical outcomes after BVS through 5 years, including beyond the 3-year time point of complete scaffold resorption. METHODS Clinical outcomes from ABSORB III were analyzed by randomized device (intention to treat) cumulative to 5 years and between 3 and 5 years. RESULTS Rates of target lesion failure, target vessel myocardial infarction, and scaffold thrombosis were increased through the 5-year follow-up with BVS compared with everolimus-eluting stents. However, between 3 and 5 years, reductions in the relative hazards of the BVS compared with everolimus-eluting stents were observed, particularly for target lesion failure (hazard ratio, 0.83 [95% CI, 0.55-1.24] versus 1.35 [95% CI, 1.02-1.78]; P int =0.052) and scaffold thrombosis (hazard ratio, 0.26 [95% CI, 0.02-2.87] versus 3.23 [95% CI, 1.25-8.30]; P int =0.056) compared with the 0- to 3-year time period. CONCLUSIONS In the ABSORB III trial, cumulative 5-year adverse event rates were increased after BVS compared with everolimus-eluting stents. However, the period of excess risk for BVS ended at 3 years, coincident with complete scaffold resorption. CLINICAL TRIAL REGISTRATION URL: https://clinicaltrials.gov. Unique identifier: NCT01751906.",2019,"Rates of TLF, TVMI and ST were increased through 5-year follow-up with BVS compared with EES.",[],"['cobalt chromium everolimus-eluting stents (EES', 'Complete Everolimus-Eluting Bioresorbable Scaffold Resorption', 'Absorb everolimus-eluting bioresorbable vascular scaffold (BVS']","['cumulative 5-year adverse event rates', 'relative hazards of BVS', 'Rates of TLF, TVMI and ST', 'cumulative to 3 years adverse event rates (particularly TVMI and scaffold thrombosis [ST', 'inferior rates of target lesion failure (TLF; cardiac death, target vessel myocardial infarction [TVMI] or ischemia-driven target lesion revascularization']",[],"[{'cui': 'C0009148', 'cui_str': 'Cobalt'}, {'cui': 'C0168430', 'cui_str': 'chromium hexavalent ion'}, {'cui': 'C0541315', 'cui_str': 'everolimus'}, {'cui': 'C0038257', 'cui_str': 'Stents'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0337143', 'cui_str': 'Scaffold, device (physical object)'}]","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C0337143', 'cui_str': 'Scaffold, device (physical object)'}, {'cui': 'C0040053', 'cui_str': 'Thrombosis'}, {'cui': 'C0542339', 'cui_str': 'Below (qualifier value)'}, {'cui': 'C0014742', 'cui_str': 'Erythema Multiforme'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0376297', 'cui_str': 'Cardiac Death'}, {'cui': 'C0449618', 'cui_str': 'Target vessel (attribute)'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C0004379', 'cui_str': 'Drivings, Automobile'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}]",,0.175231,"Rates of TLF, TVMI and ST were increased through 5-year follow-up with BVS compared with EES.","[{'ForeName': 'Dean J', 'Initials': 'DJ', 'LastName': 'Kereiakes', 'Affiliation': 'The Christ Hospital Heart and Vascular Center, Lindner Research Center, Cincinnati, OH (D.J.K.).'}, {'ForeName': 'Stephen G', 'Initials': 'SG', 'LastName': 'Ellis', 'Affiliation': 'Cleveland Clinic, OH (S.G.E.).'}, {'ForeName': 'D Christopher', 'Initials': 'DC', 'LastName': 'Metzger', 'Affiliation': 'Wellmont Holston Valley Medical Center, Kingsport, TN (D.C.M.).'}, {'ForeName': 'Ronald P', 'Initials': 'RP', 'LastName': 'Caputo', 'Affiliation': ""St. Joseph's Hospital Health Center, Liverpool, NY (R.P.C.).""}, {'ForeName': 'David G', 'Initials': 'DG', 'LastName': 'Rizik', 'Affiliation': 'Scottsdale Healthcare, AZ (D.G.R.).'}, {'ForeName': 'Paul S', 'Initials': 'PS', 'LastName': 'Teirstein', 'Affiliation': 'Scripps Clinic, La Jolla, CA (P.S.T.).'}, {'ForeName': 'Marc R', 'Initials': 'MR', 'LastName': 'Litt', 'Affiliation': 'Baptist Medical Center, Jacksonville, FL (M.R.L.).'}, {'ForeName': 'Annapoorna', 'Initials': 'A', 'LastName': 'Kini', 'Affiliation': 'Mount Sinai Medical Center, New York (A. Kini).'}, {'ForeName': 'Ameer', 'Initials': 'A', 'LastName': 'Kabour', 'Affiliation': ""Mercy St. Vincent's Medical Center, Toledo, OH (A. Kabour).""}, {'ForeName': 'Steven O', 'Initials': 'SO', 'LastName': 'Marx', 'Affiliation': 'New York Presbyterian Hospital, Columbia University Medical Center and the Cardiovascular Research Foundation (S.O.M., G.W.S.).'}, {'ForeName': 'Jeffrey J', 'Initials': 'JJ', 'LastName': 'Popma', 'Affiliation': 'Beth Israel Deaconess Medical Center, Boston, MA (J.J.P.).'}, {'ForeName': 'Siok Hwee', 'Initials': 'SH', 'LastName': 'Tan', 'Affiliation': 'Abbott Vascular, Santa Clara, CA (S.H.T., D.E.E., C.S.).'}, {'ForeName': 'Divine E', 'Initials': 'DE', 'LastName': 'Ediebah', 'Affiliation': 'Abbott Vascular, Santa Clara, CA (S.H.T., D.E.E., C.S.).'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Simonton', 'Affiliation': 'Abbott Vascular, Santa Clara, CA (S.H.T., D.E.E., C.S.).'}, {'ForeName': 'Gregg W', 'Initials': 'GW', 'LastName': 'Stone', 'Affiliation': 'New York Presbyterian Hospital, Columbia University Medical Center and the Cardiovascular Research Foundation (S.O.M., G.W.S.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Circulation,['10.1161/CIRCULATIONAHA.119.042584'] 997,31733813,"Task-sharing of psychological treatment for antenatal depression in Khayelitsha, South Africa: Effects on antenatal and postnatal outcomes in an individual randomised controlled trial.","The study's objective was to determine the effectiveness of a task-sharing psychological treatment for perinatal depression using non-specialist community health workers. A double-blind individual randomised controlled trial was conducted in two antenatal clinics in the peri-urban settlement of Khayelitsha, Cape Town. Adult pregnant women who scored 13 or above on the Edinburgh Postnatal Depression rating Scale (EPDS) were randomised into the intervention arm (structured six-session psychological treatment) or the control arm (routine antenatal health care and three monthly phone calls). The primary outcome was response on the Hamilton Depression Rating Scale (HDRS) at three months postpartum (minimum 40% score reduction from baseline) among participants who did not experience pregnancy or infant loss (modified intention-to-treat population) (registered on Clinical Trials: NCT01977326). Of 2187 eligible women approached, 425 (19.4%) screened positive on the EPDS and were randomised; 384 were included in the modified intention-to-treat analysis (control: n = 200; intervention: n = 184). There were no significant differences in response on the HDRS at three months postpartum between the intervention and control arm. A task-sharing psychological treatment was not effective in treating depression among women living in Khayelitsha, South Africa. The findings give cause for reflection on the strategy of task-sharing in low-resource settings.",2020,"A task-sharing psychological treatment was not effective in treating depression among women living in Khayelitsha, South Africa.","['two antenatal clinics in the peri-urban settlement of Khayelitsha, Cape Town', 'antenatal depression in Khayelitsha, South Africa', 'perinatal depression using non-specialist community health workers', 'Adult pregnant women who scored 13 or above on the Edinburgh Postnatal Depression rating Scale (EPDS', '2187 eligible women approached, 425 (19.4%) screened positive on the EPDS and were randomised; 384 were included in the modified intention-to-treat analysis (control: n\u202f=\u202f200; intervention: n\u202f=\u202f184', 'women living in Khayelitsha, South Africa']","['Task-sharing of psychological treatment', 'intervention arm (structured six-session psychological treatment) or the control arm (routine antenatal health care and three monthly phone calls', 'task-sharing psychological treatment']","['HDRS', 'Hamilton Depression Rating Scale (HDRS']","[{'cui': 'C1274027', 'cui_str': 'Antenatal clinic'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0453952', 'cui_str': 'Cape (physical object)'}, {'cui': 'C0557750', 'cui_str': 'Towns'}, {'cui': 'C2828394', 'cui_str': 'Antenatal (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0037712', 'cui_str': 'Union of South Africa'}, {'cui': 'C4284586', 'cui_str': 'Perinatal depression'}, {'cui': 'C0087009', 'cui_str': 'Specialists'}, {'cui': 'C0009467', 'cui_str': 'Community Health Aides'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0221074', 'cui_str': 'Postnatal Depression'}, {'cui': 'C0222045'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C3844105', 'cui_str': '425 (qualifier value)'}, {'cui': 'C4709305', 'cui_str': '19.4 (qualifier value)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C4517616', 'cui_str': 'One hundred and eighty-four'}]","[{'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C2828394', 'cui_str': 'Antenatal (qualifier value)'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}, {'cui': 'C1720420', 'cui_str': 'Call'}]","[{'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0222045'}]",2187.0,0.206439,"A task-sharing psychological treatment was not effective in treating depression among women living in Khayelitsha, South Africa.","[{'ForeName': 'Crick', 'Initials': 'C', 'LastName': 'Lund', 'Affiliation': ""Alan J Flisher Centre for Public Mental Health, Department of Psychiatry and Mental Health, University of Cape Town, South Africa; King's College London, Centre for Global Mental Health, Health Service and Population Research Department, Institute of Psychiatry, Psychology and Neuroscience, London, UK. Electronic address: crick.lund@uct.ac.za.""}, {'ForeName': 'Marguerite', 'Initials': 'M', 'LastName': 'Schneider', 'Affiliation': 'Alan J Flisher Centre for Public Mental Health, Department of Psychiatry and Mental Health, University of Cape Town, South Africa.'}, {'ForeName': 'Emily C', 'Initials': 'EC', 'LastName': 'Garman', 'Affiliation': 'Alan J Flisher Centre for Public Mental Health, Department of Psychiatry and Mental Health, University of Cape Town, South Africa.'}, {'ForeName': 'Thandi', 'Initials': 'T', 'LastName': 'Davies', 'Affiliation': 'Alan J Flisher Centre for Public Mental Health, Department of Psychiatry and Mental Health, University of Cape Town, South Africa.'}, {'ForeName': 'Memory', 'Initials': 'M', 'LastName': 'Munodawafa', 'Affiliation': 'Alan J Flisher Centre for Public Mental Health, Department of Psychiatry and Mental Health, University of Cape Town, South Africa.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Honikman', 'Affiliation': 'Perinatal Mental Health Project, Alan J Flisher Centre for Public Mental Health, Department of Psychiatry and Mental Health, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Arvin', 'Initials': 'A', 'LastName': 'Bhana', 'Affiliation': 'Medical Research Council, Durban, South Africa; Centre for Rural Health, School of Nursing and Public Health, University of KwaZulu-Natal, Durban, South Africa.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Bass', 'Affiliation': 'Department of Mental Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, USA; Center for Humanitarian Health, Departments of International Health and Mental Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Bolton', 'Affiliation': 'Department of Mental Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, USA; Center for Humanitarian Health, Departments of International Health and Mental Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Dewey', 'Affiliation': ""King's College London, Centre for Global Mental Health, Health Service and Population Research Department, Institute of Psychiatry, Psychology and Neuroscience, London, UK.""}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Joska', 'Affiliation': 'Department of Psychiatry and Mental Health, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Ashraf', 'Initials': 'A', 'LastName': 'Kagee', 'Affiliation': 'Alan J Flisher Centre for Public Mental Health, Department of Psychology, Stellenbosch University, Stellenbosch, South Africa.'}, {'ForeName': 'Landon', 'Initials': 'L', 'LastName': 'Myer', 'Affiliation': 'Division of Epidemiology & Biostatistics, School of Public Health and Family Medicine, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Inge', 'Initials': 'I', 'LastName': 'Petersen', 'Affiliation': 'Centre for Rural Health, School of Nursing and Public Health, University of KwaZulu-Natal, Durban, South Africa.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Prince', 'Affiliation': ""King's College London, Centre for Global Mental Health, Health Service and Population Research Department, Institute of Psychiatry, Psychology and Neuroscience, London, UK.""}, {'ForeName': 'Dan J', 'Initials': 'DJ', 'LastName': 'Stein', 'Affiliation': 'Department of Psychiatry and Mental Health, University of Cape Town, Cape Town, South Africa; MRC Unit on Risk & Resilience in Mental Disorders, Medical Research Council, Cape Town, South Africa.'}, {'ForeName': 'Hanani', 'Initials': 'H', 'LastName': 'Tabana', 'Affiliation': 'School of Public Health, University of the Western Cape, Cape Town, South Africa.'}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'Thornicroft', 'Affiliation': ""King's College London, Centre for Global Mental Health, Health Service and Population Research Department, Institute of Psychiatry, Psychology and Neuroscience, London, UK.""}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Tomlinson', 'Affiliation': 'Institute for Life Course Health Research, Department of Global Health, Stellenbosch University, Cape Town, South Africa, And School of Nursing and Midwifery, Queens University, Belfast, UK.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Hanlon', 'Affiliation': ""King's College London, Centre for Global Mental Health, Health Service and Population Research Department, Institute of Psychiatry, Psychology and Neuroscience, London, UK; Department of Psychiatry, School of Medicine, College of Health Sciences, Addis Ababa University, Addis Ababa, Ethiopia; Centre for Innovative Drug Development and Therapeutic Trials for Africa (CDT-Africa), College of Health Sciences, Addis Ababa University, Addis Ababa, Ethiopia.""}, {'ForeName': 'Atalay', 'Initials': 'A', 'LastName': 'Alem', 'Affiliation': 'Department of Psychiatry, School of Medicine, College of Health Sciences, Addis Ababa University, Addis Ababa, Ethiopia.'}, {'ForeName': 'Ezra', 'Initials': 'E', 'LastName': 'Susser', 'Affiliation': 'Mailman School of Public Health, Columbia University, New York, USA; New York State Psychiatric Institute, New York, USA.'}]",Behaviour research and therapy,['10.1016/j.brat.2019.103466'] 998,31116358,Effect of Targeting Mean Arterial Pressure During Cardiopulmonary Bypass by Monitoring Cerebral Autoregulation on Postsurgical Delirium Among Older Patients: A Nested Randomized Clinical Trial.,"Importance Delirium occurs in up to 52% of patients after cardiac surgery and may result from changes in cerebral perfusion. Using intraoperative cerebral autoregulation monitoring to individualize and optimize cerebral perfusion may be a useful strategy to reduce the incidence of delirium after cardiac surgery. Objective To determine whether targeting mean arterial pressure during cardiopulmonary bypass (CPB) using cerebral autoregulation monitoring reduces the incidence of delirium compared with usual care. Design, Setting, and Participants This randomized clinical trial nested within a larger trial enrolled patients older than 55 years who underwent nonemergency cardiac surgery at a single US academic medical center between October 11, 2012, and May 10, 2016, and had a high risk for neurologic complications. Patients, physicians, and outcome assessors were masked to the assigned intervention. A total of 2764 patients were screened, and 199 were eligible for analysis in this study. Intervention In the intervention group, the patient's lower limit of cerebral autoregulation was identified during surgery before CPB. On CPB, the patient's mean arterial pressure was targeted to be greater than that patient's lower limit of autoregulation. In the control group, mean arterial pressure targets were determined according to institutional practice. Main Outcomes and Measures The main outcome was any incidence of delirium on postoperative days 1 through 4, as adjudicated by a consensus expert panel. Results Among the 199 participants in this study, mean (SD) age was 70.3 (7.5) years and 150 (75.4%) were male. One hundred sixty-two (81.4%) were white, 26 (13.1%) were black, and 11 (5.5%) were of other race. Of 103 patients randomized to usual care, 94 were analyzed, and of 102 patients randomized to the intervention 105 were analyzed. Excluding 5 patients with coma, delirium occurred in 48 of the 91 patients (53%) in the usual care group compared with 39 of the 103 patients (38%) in the intervention group (P = .04). The odds of delirium were reduced by 45% in patients randomized to the autoregulation group (odds ratio, 0.55; 95% CI, 0.31-0.97; P = .04). Conclusions and Relevance The results of this study suggest that optimizing mean arterial pressure to be greater than the individual patient's lower limit of cerebral autoregulation during CPB may reduce the incidence of delirium after cardiac surgery, but further study is needed. Trial Registration ClinicalTrials.gov identifier: NCT00981474.",2019,"Excluding 5 patients with coma, delirium occurred in 48 of the 91 patients (53%) in the usual care group compared with 39 of the 103 patients (38%) in the intervention group (P = .04).","['199 participants in this study, mean (SD) age was 70.3 (7.5) years and 150 (75.4%) were male', 'Older Patients', 'A total of 2764 patients were screened, and 199 were eligible for analysis in this study', '103 patients randomized to usual care, 94 were analyzed, and of 102 patients randomized to the intervention 105 were analyzed', 'One hundred sixty-two (81.4%) were white, 26 (13.1%) were black, and 11 (5.5%) were of other race', 'larger trial enrolled patients older than 55 years who underwent nonemergency cardiac surgery at a single US academic medical center between October 11, 2012, and May 10, 2016, and had a high risk for neurologic complications']","['Mean Arterial Pressure During Cardiopulmonary Bypass by Monitoring Cerebral Autoregulation', 'cardiopulmonary bypass (CPB) using cerebral autoregulation monitoring']","['odds of delirium', 'cerebral autoregulation', 'cerebral perfusion', 'delirium', 'incidence of delirium', 'mean arterial pressure targets', 'mean arterial pressure']","[{'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517859', 'cui_str': 'Seven point five'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C4517526', 'cui_str': 'One hundred and three'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C4517835', 'cui_str': '62 (qualifier value)'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C3844008', 'cui_str': '5.5'}, {'cui': 'C3853635', 'cui_str': 'Race (observable entity)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0524727', 'cui_str': 'Surgery, Cardiac'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0000872', 'cui_str': 'University Medical Centers'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0205494', 'cui_str': 'Neurologic (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}]","[{'cui': 'C0428886', 'cui_str': 'Mean Arterial Pressure'}, {'cui': 'C0007202', 'cui_str': 'Heart-Lung Bypass'}, {'cui': 'C0181904', 'cui_str': 'Monitor, device (physical object)'}, {'cui': 'C0019868', 'cui_str': 'Autoregulation'}]","[{'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0019868', 'cui_str': 'Autoregulation'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0428886', 'cui_str': 'Mean Arterial Pressure'}]",2764.0,0.273762,"Excluding 5 patients with coma, delirium occurred in 48 of the 91 patients (53%) in the usual care group compared with 39 of the 103 patients (38%) in the intervention group (P = .04).","[{'ForeName': 'Charles H', 'Initials': 'CH', 'LastName': 'Brown', 'Affiliation': 'Department of Anesthesiology and Critical Care Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Karin J', 'Initials': 'KJ', 'LastName': 'Neufeld', 'Affiliation': 'Department of Psychiatry, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Tian', 'Affiliation': 'Department of Biostatistics, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Probert', 'Affiliation': 'School of Medicine, New York University, New York.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'LaFlam', 'Affiliation': 'Medical Student, School of Medicine, Tufts University, Medford Massachusetts.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Max', 'Affiliation': 'Department of Radiology, Massachusetts General Hospital, Boston.'}, {'ForeName': 'Daijiro', 'Initials': 'D', 'LastName': 'Hori', 'Affiliation': 'Department of Cardiovascular Surgery, Saitama Medical Center, Jichi Medical University, Saitama, Japan.'}, {'ForeName': 'Yohei', 'Initials': 'Y', 'LastName': 'Nomura', 'Affiliation': 'Department of Cardiovascular Surgery, Saitama Medical Center, Jichi Medical University, Saitama, Japan.'}, {'ForeName': 'Kaushik', 'Initials': 'K', 'LastName': 'Mandal', 'Affiliation': 'Division of Cardiac Surgery, Department of Surgery, Penn State University Hershey Medical Center, Hershey, Pennsylvania.'}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Brady', 'Affiliation': 'Department of Anesthesiology, Northwestern University Feinberg School of Medicine, Chicago, Illinois.'}, {'ForeName': 'Charles W', 'Initials': 'CW', 'LastName': 'Hogue', 'Affiliation': 'Bluhm Cardiovascular Institute, Department of Anesthesiology, Northwestern University Feinberg School of Medicine, Chicago, Illinois.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'Ashish', 'Initials': 'A', 'LastName': 'Shah', 'Affiliation': 'Department of Cardiac Surgery, Vanderbilt University Medical Center, Nashville, Tennessee.'}, {'ForeName': 'Kenton', 'Initials': 'K', 'LastName': 'Zehr', 'Affiliation': 'Division of Cardiac Surgery, Department of Surgery, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Duke', 'Initials': 'D', 'LastName': 'Cameron', 'Affiliation': 'Division of Cardiac Surgery, Department of Surgery, Massachusetts General Hospital, Boston.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Conte', 'Affiliation': 'Division of Cardiac Surgery, Department of Surgery, Penn State University Hershey Medical Center, Hershey, Pennsylvania.'}, {'ForeName': 'O Joseph', 'Initials': 'OJ', 'LastName': 'Bienvenu', 'Affiliation': 'Department of Psychiatry, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Gottesman', 'Affiliation': 'Department of Neurology, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Yamaguchi', 'Affiliation': 'Saitama Medical Center, Jichi Medical University, Saitama, Japan.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Kraut', 'Affiliation': 'Department of Radiology and Radiological Sciences, Johns Hopkins University School of Medicine, Baltimore, Maryland.'}]",JAMA surgery,['10.1001/jamasurg.2019.1163'] 999,30947622,Dance Intervention for Mexican Family Caregivers of Children With Developmental Disability: A Pilot Study.,"Introduction: There are 7.1 million people living with a disability in Mexico. Of these individuals, 7% are children and adolescents with developmental disabilities. Mexican women caring for children with a developmental disability are at risk of psychological stress, which may be prevented with physical activity such as dance. Therefore, the purpose of this pilot study was to examine (a) the feasibility of implementing the dance intervention, (b) the mothers' satisfaction with the intervention, and (c) the changes in stress level experienced by the mothers on completion of the intervention. Method: A one-group pretest-posttest design was used. The Salsa dance intervention was given in nine 60-minute sessions, twice a week in Veracruz, Mexico. The sample included 14 mothers of children with disabilities. The outcome, stress level, was measured with the validated Questionnaire of Perceived Stress. Feasibility of intervention implementation was maintained by having the interventionist follow the interventionist manual. Satisfaction was assessed by the Satisfaction with Therapy and Therapist Scale. Results: The intervention was feasible as all participants completed the intervention sessions. They reported high satisfaction (100%) with the intervention and interventionist. At posttest, participants showed reduced stress levels ( p = .028). Discussion: The dance intervention is promising in reducing women's stress levels and worth further development in order to benefit the Mexican women caring for children with developmental disability and experiencing stress. Nurses can implement the Salsa dance intervention with the Mexican population while improving the clients' retention, outcomes, and overall satisfaction.",2020,"At posttest, participants showed reduced stress levels ( p = .028). ","['Mexican women caring for children with developmental disability and experiencing stress', 'Mexican women caring for children with a developmental disability', '7.1 million people living with a disability in Mexico', 'Mexican Family Caregivers of Children', 'children and adolescents with developmental disabilities', '14 mothers of children with disabilities']",['Dance Intervention'],"['reduced stress levels', 'Satisfaction', 'validated Questionnaire of Perceived Stress', 'Satisfaction with Therapy and Therapist Scale', 'stress level']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0008073', 'cui_str': 'Child Development Disorders'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0025885', 'cui_str': 'Mexico'}, {'cui': 'C0086279', 'cui_str': 'Family Caregivers'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0259916', 'cui_str': 'Children with Disabilities'}]","[{'cui': 'C0010963', 'cui_str': 'Dancing'}]","[{'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C1319127', 'cui_str': 'Level of stress'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0222045'}]",,0.017061,"At posttest, participants showed reduced stress levels ( p = .028). ","[{'ForeName': 'Higinio', 'Initials': 'H', 'LastName': 'Fernández Sánchez', 'Affiliation': 'Universidad Veracruzana, Campus Poza Rica-Tuxpan, Veracruz, Mexico.'}, {'ForeName': 'Claudia Beatriz Enríquez', 'Initials': 'CBE', 'LastName': 'Hernández', 'Affiliation': 'Universidad Veracruzana, Campus Veracruz, Veracruz, Mexico.'}, {'ForeName': 'Souraya', 'Initials': 'S', 'LastName': 'Sidani', 'Affiliation': 'Ryerson University, Toronto, Ontario, Canada.'}, {'ForeName': 'Crescencio Hernández', 'Initials': 'CH', 'LastName': 'Osorio', 'Affiliation': 'Universidad Veracruzana, Campus Xalapa, Veracruz, Mexico.'}, {'ForeName': 'Edith Castellanos', 'Initials': 'EC', 'LastName': 'Contreras', 'Affiliation': 'Universidad Veracruzana, Campus Veracruz, Veracruz, Mexico.'}, {'ForeName': 'Javier Salazar', 'Initials': 'JS', 'LastName': 'Mendoza', 'Affiliation': 'Universidad Veracruzana, Campus Veracruz, Veracruz, Mexico.'}]",Journal of transcultural nursing : official journal of the Transcultural Nursing Society,['10.1177/1043659619838027'] 1000,31783800,Effectiveness of eHealth cardiac rehabilitation on health outcomes of coronary heart disease patients: a randomized controlled trial protocol.,"BACKGROUND Cardiac rehabilitation (CR) uptake and adherence remain sub-optimal despite the apparent health benefits of modifying healthy behavior and slowing disease progression. eHealth is the use of information and communication technology (ICT) for health. eHealth lifestyle interventions and disease management have emerged as modalities to enhance CR accessibility, enable an individualized progress page, and enrich real-time contact, video-based information, and technology monitored functionality. This study aims to develop a nurse-led eHealth cardiac rehabilitation (NeCR) intervention and investigate its effectiveness on coronary heart disease (CHD) patients' health outcomes. METHODS This single-blinded two-arm parallel randomized controlled trial will randomize 146 patients from the inpatient cardiovascular units of a hospital in Wuhan, China to receive either the NeCR or the usual care. The NeCR intervention uses a hybrid approach consisting of a brief face-to-face preparatory phase and an empowerment phase delivered by health technology. The preparatory phase aims at identifying self-care needs, developing a goal-oriented patient centered action plan, incorporating a peer support network and orientation to the use of the e-platform. The empowerment phase includes use of the multi-media interactive NeCR for promoting symptom management, monitoring lifestyle changes and offering psychological support. A tele-care platform is also integrated to enhance health care dialogue with health professionals and peer groups. The control group will receive the usual care. An evaluation of lifestyle behavioral changes, self-efficacy, health-related quality of life, anxiety and depression, cardiovascular risk parameters, and unplanned health services use will be conducted at baseline, 6 weeks and 12 weeks post-intervention. DISCUSSION This protocol proposes an individualized, comprehensive, and interactive NeCR delivered using a hybrid approach and guided by an empowerment model to optimize health outcomes of CHD patients. The intervention content and web-design is based on international health guidelines to improve credibility, comprehensibility and implementation. This study also proposes a new method of peer support in which the researcher shares participants' progress toward goal attainment with the peer group. Results of this research have the potential to increase accessibility and availability of CR, improve cardiac rehabilitation service development in China, and inform eHealth lifestyle interventions. TRIAL REGISTRATION Chinese Clinical Trial Registry: ChiCTR1800020411; Date of registration: December 28, 2018.",2019,"The empowerment phase includes use of the multi-media interactive NeCR for promoting symptom management, monitoring lifestyle changes and offering psychological support.","['coronary heart disease patients', '146 patients from the inpatient cardiovascular units of a hospital in Wuhan, China to receive either the NeCR or the usual care']","['nurse-led eHealth cardiac rehabilitation (NeCR) intervention', 'eHealth cardiac rehabilitation']","['health outcomes', 'lifestyle behavioral changes, self-efficacy, health-related quality of life, anxiety and depression, cardiovascular risk parameters, and unplanned health services']","[{'cui': 'C0010068', 'cui_str': 'Coronary Disease'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}]","[{'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C1328956', 'cui_str': 'eHealth'}, {'cui': 'C0700431', 'cui_str': 'Cardiovascular Rehabilitation'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0018747', 'cui_str': 'Health Services'}]",146.0,0.0738171,"The empowerment phase includes use of the multi-media interactive NeCR for promoting symptom management, monitoring lifestyle changes and offering psychological support.","[{'ForeName': 'Jing Jing', 'Initials': 'JJ', 'LastName': 'Su', 'Affiliation': 'Faculty of Medicine, The Nethersole School of Nursing, the Chinese University of Hong Kong, Room 601, Esther Lee building, Shatin, 999077, Hong Kong. sujj@link.cuhk.edu.hk.'}, {'ForeName': 'Doris Sau Fung', 'Initials': 'DSF', 'LastName': 'Yu', 'Affiliation': 'Faculty of Medicine, The Nethersole School of Nursing, the Chinese University of Hong Kong, Room 601, Esther Lee building, Shatin, 999077, Hong Kong.'}]",BMC cardiovascular disorders,['10.1186/s12872-019-1262-5'] 1001,31035472,Using the Avocado to Test the Satiety Effects of a Fat-Fiber Combination in Place of Carbohydrate Energy in a Breakfast Meal in Overweight and Obese Men and Women: A Randomized Clinical Trial.,"This study aimed to investigate the satiety effects of isocalorically replacing carbohydrate energy in a meal with avocado-derived fats and fibers. In a randomized 3-arm, 6-h, crossover clinical trial, thirty-one overweight/obese adults consumed a low-fat control meal (CON, 76% carbohydrate, 14% fat as energy, 5 g fiber, ~640 kcal) or high-fat meals similar in total fat and energy, but increasing avocado-derived fat and fiber content from half (HA, 68 g; 51% carbohydrate, 40% fat as energy, 8.6 g fiber) or whole avocado (WA, 136 g; 50% carbohydrate, 43% fat as energy, 13.1 g fiber) on three separate occasions. Visual analog scales (VAS) assessed subjective satiety over 6 h. Hormones associated with satiety/appetite were measured in blood collected immediately after VAS. Stepwise multiple regression analysis was used to assess the relationship of VAS with hormones in WA and CON. Hunger suppression was enhanced after the WA compared to CON meal ( p < 0.01). Subjects indicated feeling more satisfied after both HA and WA than CON ( p < 0.05). Fullness was greater after CON and WA vs. HA ( p < 0.005). PYY and GLP-1 were significantly elevated after WA vs. CON ( p < 0.05), while insulin was significantly higher after CON vs. WA ( p < 0.0001). Ghrelin was suppressed more by CON than WA ( p < 0.05). Regression analysis indicated PYY was associated with subjective satiety after WA, whereas increased insulin predicted changes in subjective satiety after CON. Replacing carbohydrates in a high-carbohydrate meal with avocado-derived fat-fiber combination increased feelings of satiety mediated primarily by PYY vs. insulin. These findings may have important implications for addressing appetite management and metabolic concerns.",2019,"PYY and GLP-1 were significantly elevated after WA vs. CON ( p < 0.05), while insulin was significantly higher after CON vs. WA ( p < 0.0001).","['Overweight and Obese Men and Women', 'thirty-one overweight/obese adults']","['Breakfast Meal', 'low-fat control meal (CON, 76% carbohydrate, 14% fat as energy, 5 g fiber, ~640 kcal) or high-fat meals similar in total fat and energy, but increasing avocado-derived fat and fiber content from half (HA, 68 g; 51% carbohydrate, 40% fat as energy, 8.6 g fiber) or whole avocado (WA, 136 g; 50% carbohydrate', 'Fat-Fiber Combination']","['satiety/appetite', 'Hunger suppression', 'subjective satiety', 'Fullness', 'Visual analog scales (VAS) assessed subjective satiety']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0450355', 'cui_str': '31 (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C4553621', 'cui_str': 'With breakfast'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}, {'cui': 'C0225326', 'cui_str': 'Fiber'}, {'cui': 'C0439259', 'cui_str': 'kilocalorie'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0330230', 'cui_str': 'Avocado'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C4517879', 'cui_str': '8.6 (qualifier value)'}, {'cui': 'C4517568', 'cui_str': 'One hundred and thirty-six'}]","[{'cui': 'C0036239', 'cui_str': 'Satiations'}, {'cui': 'C0003618', 'cui_str': 'Appetite'}, {'cui': 'C0020175', 'cui_str': 'Hunger'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression (disorder)'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0439650', 'cui_str': 'Fullness (qualifier value)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}]",31.0,0.0395978,"PYY and GLP-1 were significantly elevated after WA vs. CON ( p < 0.05), while insulin was significantly higher after CON vs. WA ( p < 0.0001).","[{'ForeName': 'Lanjun', 'Initials': 'L', 'LastName': 'Zhu', 'Affiliation': 'Center for Nutrition Research, Institute for Food Safety and Health, Illinois Institute of Technology, Chicago, IL 60616, USA. lzhu29@hawk.iit.edu.'}, {'ForeName': 'Yancui', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': 'Center for Nutrition Research, Institute for Food Safety and Health, Illinois Institute of Technology, Chicago, IL 60616, USA. yancui22@hotmail.com.'}, {'ForeName': 'Indika', 'Initials': 'I', 'LastName': 'Edirisinghe', 'Affiliation': 'Center for Nutrition Research, Institute for Food Safety and Health, Illinois Institute of Technology, Chicago, IL 60616, USA. iedirisi@iit.edu.'}, {'ForeName': 'Eunyoung', 'Initials': 'E', 'LastName': 'Park', 'Affiliation': 'Center for Nutrition Research, Institute for Food Safety and Health, Illinois Institute of Technology, Chicago, IL 60616, USA. epark4@iit.edu.'}, {'ForeName': 'Britt', 'Initials': 'B', 'LastName': 'Burton-Freeman', 'Affiliation': 'Center for Nutrition Research, Institute for Food Safety and Health, Illinois Institute of Technology, Chicago, IL 60616, USA. bburton@iit.edu.'}]",Nutrients,['10.3390/nu11050952'] 1002,31396815,Electronic Pill Bottles or Bidirectional Text Messaging to Improve Hypertension Medication Adherence (Way 2 Text): a Randomized Clinical Trial.,"BACKGROUND Poor medication adherence contributes to inadequate control of hypertension. However, the value of adherence monitoring is unknown. OBJECTIVE To evaluate the impact of monitoring adherence with electronic pill bottles or bidirectional text messaging on improving hypertension control. DESIGN Three-arm pragmatic randomized controlled trial. PATIENTS One hundred forty-nine primary care patients aged 18-75 with hypertension and text messaging capabilities who were seen at least twice in the prior 12 months with at least two out-of-range blood pressure (BP) measurements, including the most recent visit. INTERVENTIONS Patients were randomized in a 1:2:2 ratio to receive (1) usual care, (2) electronic pill bottles for medication adherence monitoring (pill bottle), and (3) bidirectional text messaging for medication adherence monitoring (bidirectional text). MAIN MEASURES Change in systolic BP during the final 4-month visit compared with baseline. KEY RESULTS At the 4-month follow-up visit, mean (SD) change values in systolic blood pressure were - 4.7 (23.4) mmHg in usual care, - 4.3 (21.5) mmHg in the pill bottle arm, and - 4.6 (19.8) mmHg in the text arm. There was no significant change in systolic blood pressure between control and the pill bottle arm (p = 0.94) or the text messaging arm (p = 1.00), and the two intervention arms did not differ from each other (p = 0.93). CONCLUSIONS Despite good measured adherence, neither feedback with electronic pill bottles nor bidirectional text messaging about medication adherence improved blood pressure control. Adherence to prescribed medications was not improved enough to affect BP control or it was not the primary driver of poor control. TRIAL REGISTRATION clinicaltrials.gov (NCT02778542).",2019,"There was no significant change in systolic blood pressure between control and the pill bottle arm (p = 0.94) or the text messaging arm (p = 1.00), and the two intervention arms did not differ from each other (p = 0.93). ","['One hundred forty-nine primary care patients aged 18-75 with hypertension and text messaging capabilities who were seen at least twice in the prior 12\xa0months with at least two out-of-range blood pressure (BP) measurements, including the most recent visit']","['Electronic Pill Bottles or Bidirectional Text Messaging', 'electronic pill bottles or bidirectional text messaging', 'usual care, (2) electronic pill bottles for medication adherence monitoring (pill bottle), and (3) bidirectional text messaging for medication adherence monitoring (bidirectional text']","['systolic blood pressure', 'systolic BP', 'blood pressure control', 'Hypertension Medication Adherence']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C1720725', 'cui_str': 'Twice'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0005824', 'cui_str': 'Blood pressure taking (procedure)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}]","[{'cui': 'C4281784', 'cui_str': 'Electronics'}, {'cui': 'C0994475', 'cui_str': 'Pill (basic dose form)'}, {'cui': 'C4319838', 'cui_str': 'Bottle'}, {'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C2364172', 'cui_str': 'Medication Adherence'}, {'cui': 'C3541382', 'cui_str': 'Text'}]","[{'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C2364172', 'cui_str': 'Medication Adherence'}]",149.0,0.151629,"There was no significant change in systolic blood pressure between control and the pill bottle arm (p = 0.94) or the text messaging arm (p = 1.00), and the two intervention arms did not differ from each other (p = 0.93). ","[{'ForeName': 'Shivan J', 'Initials': 'SJ', 'LastName': 'Mehta', 'Affiliation': 'Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA. shivan.mehta@uphs.upenn.edu.'}, {'ForeName': 'Kevin G', 'Initials': 'KG', 'LastName': 'Volpp', 'Affiliation': 'Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Andrea B', 'Initials': 'AB', 'LastName': 'Troxel', 'Affiliation': 'Division of Biostatistics, Department of Population Health, NYU School of Medicine, New York, NY, USA.'}, {'ForeName': 'Susan C', 'Initials': 'SC', 'LastName': 'Day', 'Affiliation': 'Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Raymond', 'Initials': 'R', 'LastName': 'Lim', 'Affiliation': 'Center for Health Incentives and Behavioral Economics, Leonard Davis Institute of Health Economics, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Noora', 'Initials': 'N', 'LastName': 'Marcus', 'Affiliation': 'Center for Health Incentives and Behavioral Economics, Leonard Davis Institute of Health Economics, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Laurie', 'Initials': 'L', 'LastName': 'Norton', 'Affiliation': 'Center for Health Incentives and Behavioral Economics, Leonard Davis Institute of Health Economics, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Sophia', 'Initials': 'S', 'LastName': 'Anderson', 'Affiliation': 'Center for Health Incentives and Behavioral Economics, Leonard Davis Institute of Health Economics, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Asch', 'Affiliation': 'Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}]",Journal of general internal medicine,['10.1007/s11606-019-05241-x'] 1003,31111862,"Outcomes in Patients Treated With Thin-Strut, Very Thin-Strut, or Ultrathin-Strut Drug-Eluting Stents in Small Coronary Vessels: A Prespecified Analysis of the Randomized BIO-RESORT Trial.","Importance Stenting small-vessel lesions has an increased adverse cardiovascular event risk. Very thin-strut or ultrathin-strut drug-eluting stents might reduce this risk, but data are scarce. Objective To assess the outcome of all-comer patients with small coronary vessel lesions treated with 3 dissimilar types of drug-eluting stents. Design This is a prespecified substudy of the Comparison of Biodegradable Polymer and Durable Polymer Drug-eluting Stents in an All Comers Population (BIO-RESORT) trial, an investigator-initiated, randomized, patient-blinded comparative clinical drug-eluting stent trial. Patients treated with ultrathin-strut sirolimus-eluting stents, very thin-strut everolimus-eluting stents, or previous-generation thin-strut zotarolimus-eluting stents were enrolled from December 2012 to August 2015. This multicenter trial was conducted in 4 Dutch centers for cardiac intervention. Of all 3514 all-comer BIO-RESORT participants, 1506 patients with treatment in at least 1 small-vessel lesion (reference vessel <2.5 mm) were included. Data were analyzed between September 2018 and February 2019. Main Outcomes and Measures Target lesion failure at 3-year follow-up, a composite of cardiac death, target vessel-related myocardial infarction, or target lesion revascularization, analyzed by Kaplan-Meier methods. Results In 1452 of 1506 participants (96.4%) (1057 men [70.2%]; 449 women [29.8%]; mean [SD] age, 64.3 [10.4] years), follow-up was available. Target lesion failure occurred in 36 of 525 patients (7.0%) treated with sirolimus-eluting stents, 46 of 496 (9.5%) with everolimus-eluting stents, and 48 of 485 (10.0%) with zotarolimus-eluting stents (sirolimus-eluting vs zotarolimus-eluting hazard ratio [HR], 0.68; 95% CI, 0.44-1.05; P = .08; everolimus-eluting vs zotarolimus-eluting HR, 0.93; 95% CI, 0.62-1.39; P = .72). There was a difference in target lesion revascularizations between sirolimus-eluting and zotarolimus-eluting stents (2.1% vs 5.3%; HR, 0.40; 95% CI, 0.20-0.81; P = .009) that emerged after the first year of follow-up (1.0% vs 3.7%; P = .006); multivariate analysis showed that sirolimus-eluting stent implantation was independently associated with a lower target lesion revascularization rate at 3-year follow-up (adjusted HR, 0.42; 95% CI, 0.20-0.85; P = .02). In the everolimus-eluting stents, the revascularization rate was 4.0% (vs zotarolimus-eluting, HR, 0.74; 95% CI, 0.41-1.34; P = .31). There was no significant between-stent difference in cardiac death, target vessel myocardial infarction, or stent thrombosis. Conclusions and Relevance Patients stented in small coronary vessels experienced fewer repeated revascularizations if treated with ultrathin-strut sirolimus-eluting stents vs previous generation thin strut zotarolimus-eluting stents. Further research is required to evaluate the potential effect of particularly thin stent struts. Trial Registration ClinicalTrials.gov identifier: NCT01674803.",2019,"There was a difference in target lesion revascularizations between sirolimus-eluting and zotarolimus-eluting stents (2.1% vs 5.3%; HR, 0.40; 95% CI, 0.20-0.81; P = .009) that emerged after the first year of follow-up (1.0% vs 3.7%; P = .006); multivariate analysis showed that sirolimus-eluting stent implantation was independently associated with a lower target lesion revascularization rate at 3-year follow-up (adjusted HR, 0.42; 95% CI, 0.20-0.85; P = .02).","['Patients Treated With Thin-Strut, Very Thin-Strut, or Ultrathin-Strut Drug-Eluting Stents in Small Coronary Vessels', 'In 1452 of 1506 participants (96.4%) (1057 men [70.2%]; 449 women [29.8%]; mean [SD] age, 64.3 [10.4] years), follow-up was available', '1506 patients with treatment in at least 1 small-vessel lesion (reference vessel <2.5 mm) were included', '4 Dutch centers for cardiac intervention', 'patients with small coronary vessel lesions treated with 3 dissimilar types of drug-eluting stents']","['Biodegradable Polymer and Durable Polymer Drug-eluting Stents', 'ultrathin-strut sirolimus-eluting stents, very thin-strut everolimus-eluting stents, or previous-generation thin-strut zotarolimus-eluting stents']","['revascularization rate', 'cardiac death, target vessel myocardial infarction, or stent thrombosis', 'target lesion revascularization rate', 'target lesion revascularizations', 'Main Outcomes and Measures\n\n\nTarget lesion failure at 3-year follow-up, a composite of cardiac death, target vessel-related myocardial infarction, or target lesion revascularization, analyzed by Kaplan-Meier methods', 'Target lesion failure']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0332528', 'cui_str': 'Decreased thickness (finding)'}, {'cui': 'C0441295', 'cui_str': 'Strut (physical object)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0038257', 'cui_str': 'Stents'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C0010075', 'cui_str': 'Coronary Vessels'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0225988', 'cui_str': 'Structure of small blood vessel (organ)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0148346', 'cui_str': 'Vessel'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0013331', 'cui_str': 'Dutch (ethnic group)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0443202', 'cui_str': 'Dissimilar (qualifier value)'}, {'cui': 'C0457591', 'cui_str': 'Type of drug (attribute)'}]","[{'cui': 'C0032521', 'cui_str': 'Polymers'}, {'cui': 'C1322815', 'cui_str': 'Drug-Eluting Stents'}, {'cui': 'C0441295', 'cui_str': 'Strut (physical object)'}, {'cui': 'C0072980', 'cui_str': 'Sirolimus'}, {'cui': 'C0038257', 'cui_str': 'Stents'}, {'cui': 'C0332528', 'cui_str': 'Decreased thickness (finding)'}, {'cui': 'C0541315', 'cui_str': 'everolimus'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C1700035', 'cui_str': 'zotarilumus'}]","[{'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}, {'cui': 'C0376297', 'cui_str': 'Cardiac Death'}, {'cui': 'C0449618', 'cui_str': 'Target vessel (attribute)'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C3897493', 'cui_str': 'Stent thrombosis'}, {'cui': 'C0014742', 'cui_str': 'Erythema Multiforme'}, {'cui': 'C0205225', 'cui_str': 'Principal (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}]",1506.0,0.0929333,"There was a difference in target lesion revascularizations between sirolimus-eluting and zotarolimus-eluting stents (2.1% vs 5.3%; HR, 0.40; 95% CI, 0.20-0.81; P = .009) that emerged after the first year of follow-up (1.0% vs 3.7%; P = .006); multivariate analysis showed that sirolimus-eluting stent implantation was independently associated with a lower target lesion revascularization rate at 3-year follow-up (adjusted HR, 0.42; 95% CI, 0.20-0.85; P = .02).","[{'ForeName': 'Rosaly A', 'Initials': 'RA', 'LastName': 'Buiten', 'Affiliation': 'Department of Cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente, Enschede, the Netherlands.'}, {'ForeName': 'Eline H', 'Initials': 'EH', 'LastName': 'Ploumen', 'Affiliation': 'Department of Cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente, Enschede, the Netherlands.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Zocca', 'Affiliation': 'Department of Cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente, Enschede, the Netherlands.'}, {'ForeName': 'Carine J M', 'Initials': 'CJM', 'LastName': 'Doggen', 'Affiliation': 'Department of Health Technology and Services Research, Faculty BMS, Technical Medical Centre, University of Twente, Enschede, the Netherlands.'}, {'ForeName': 'Liefke C', 'Initials': 'LC', 'LastName': 'van der Heijden', 'Affiliation': 'Department of Cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente, Enschede, the Netherlands.'}, {'ForeName': 'Marlies M', 'Initials': 'MM', 'LastName': 'Kok', 'Affiliation': 'Department of Cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente, Enschede, the Netherlands.'}, {'ForeName': 'Peter W', 'Initials': 'PW', 'LastName': 'Danse', 'Affiliation': 'Department of Cardiology, Rijnstate Hospital, Arnhem, the Netherlands.'}, {'ForeName': 'Carl E', 'Initials': 'CE', 'LastName': 'Schotborgh', 'Affiliation': 'Department of Cardiology, Haga Hospital, The Hague, the Netherlands.'}, {'ForeName': 'Martijn', 'Initials': 'M', 'LastName': 'Scholte', 'Affiliation': 'Department of Cardiology, Albert Schweitzer Hospital, Dordrecht, the Netherlands.'}, {'ForeName': 'Frits H A F', 'Initials': 'FHAF', 'LastName': 'de Man', 'Affiliation': 'Department of Cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente, Enschede, the Netherlands.'}, {'ForeName': 'Gerard C M', 'Initials': 'GCM', 'LastName': 'Linssen', 'Affiliation': 'Department of Cardiology, Hospital Group Twente, Almelo and Hengelo, the Netherlands.'}, {'ForeName': 'Clemens', 'Initials': 'C', 'LastName': 'von Birgelen', 'Affiliation': 'Department of Cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente, Enschede, the Netherlands.'}]",JAMA cardiology,['10.1001/jamacardio.2019.1776'] 1004,31181186,Randomized Controlled Trial of Motivational Interviewing to Support Breastfeeding Among Appalachian Women.,"OBJECTIVE To determine the effectiveness of a single session of prenatal motivational interviewing (MI) to enhance breastfeeding outcomes. DESIGN A randomized controlled trial with two groups (MI and psychoeducation) with repeated measures: preintervention, postintervention, and at 1 month postpartum. SETTING The intervention was conducted at a university-associated clinic, community locations, and participants' homes. Postpartum follow-up was conducted by telephone. PARTICIPANTS A total of 81 women with low-risk pregnancies enrolled at 28 to 39 weeks gestation who lived in Appalachia. METHODS Participants were randomly assigned to MI or psychoeducation on infant development. Pre- and postintervention outcome measures included intention to breastfeed, confidence in and importance of breastfeeding plan, and breastfeeding attitudes. At 1 month postpartum, participants completed a telephone interview to assess actual breastfeeding initiation, exclusivity, and plans to continue breastfeeding. RESULTS At 1 month postpartum, women in the MI group were more likely to report any current breastfeeding than women in the psychoeducation group, regardless of parity, χ 2 (1, N = 79) = 4.30, p = .040, Φ = .233. At the postintervention time point, the MI intervention had a significant effect on improving attitudes about breastfeeding among primiparous women only (p < .05). CONCLUSION One session of MI was effective to promote breastfeeding at 1 month postpartum and to enhance positive attitudes toward breastfeeding among primiparous women in Appalachia.",2019,"At the postintervention time point, the MI intervention had a significant effect on improving attitudes about breastfeeding among primiparous women only (p < .05). ","['A total of 81 women with low-risk pregnancies enrolled at 28 to 39\xa0weeks gestation who lived in Appalachia', ""The intervention was conducted at a university-associated clinic, community locations, and participants' homes"", 'Participants', 'Appalachian Women', 'primiparous women in Appalachia']","['MI or psychoeducation', 'prenatal motivational interviewing (MI', 'Motivational Interviewing to Support', 'telephone interview to assess actual breastfeeding initiation, exclusivity, and plans to continue breastfeeding']","['likely to report any current breastfeeding', 'intention to breastfeed, confidence in and importance of breastfeeding plan, and breastfeeding attitudes', 'attitudes about breastfeeding']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0404841', 'cui_str': 'Low risk pregnancy (finding)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0003609', 'cui_str': 'Appalachia'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0450429', 'cui_str': 'Location (attribute)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0033150', 'cui_str': 'Primiparity'}]","[{'cui': 'C0871175', 'cui_str': 'Psycho-education'}, {'cui': 'C0683474', 'cui_str': 'Motivational Interviewing'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0021823', 'cui_str': 'Interviews, Telephone'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation (observable entity)'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C1623040', 'cui_str': 'Breastfeeding (mother)'}]","[{'cui': 'C0332148', 'cui_str': 'Probable diagnosis (contextual qualifier) (qualifier value)'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1623040', 'cui_str': 'Breastfeeding (mother)'}, {'cui': 'C0237529', 'cui_str': 'Self Confidence'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}]",81.0,0.0787234,"At the postintervention time point, the MI intervention had a significant effect on improving attitudes about breastfeeding among primiparous women only (p < .05). ","[{'ForeName': 'Sarah H', 'Initials': 'SH', 'LastName': 'Addicks', 'Affiliation': ''}, {'ForeName': 'Daniel W', 'Initials': 'DW', 'LastName': 'McNeil', 'Affiliation': ''}]","Journal of obstetric, gynecologic, and neonatal nursing : JOGNN",['10.1016/j.jogn.2019.05.003'] 1005,31103367,Effectiveness of a multimodal intervention to increase vaccination in obstetrics/gynecology settings.,"OBJECTIVE To test the effectiveness of a multimodal intervention in obstetrics/gynecology (ob-gyn) clinics to increase uptake of influenza and tetanus-diphtheria-acellular pertussis (Tdap) vaccines in pregnant women and these vaccines plus human papillomavirus (HPV) vaccine in non-pregnant women. METHODS A cluster randomized controlled trial among 9 private ob-gyn practices in Colorado from 9/2011 to 5/2014. The intervention consisted of: designation of immunization champions, staff/provider trainings, assistance with vaccine purchasing/management, identification of eligible patients, standing order implementation, chart review/feedback, and patient education materials. Control practices continued usual care. Primary outcomes were receipt of influenza and Tdap vaccines among pregnant women and these vaccines plus HPV vaccine among non-pregnant women, comparing a Baseline period (Year 0/Year 1) to Year 2, intervention versus control. With an estimated sample size of 32,590 per arm, there would be >80% power to detect a 10% difference between groups. RESULTS In the Baseline period, 27% of pregnant women in both intervention and control practices received influenza vaccine. In Year 2, 29% of pregnant women in intervention practices received influenza vaccine versus 41% in control practices. In the Baseline period, 18% of pregnant women in intervention practices received Tdap vaccine versus 22% in control practices. Both intervention and control practices increased to 51% in Year 2, representing an increase of 33% for intervention practices and 29% for control practices, consistent with a change in Tdap recommendations. Relatively few HPV, influenza or Tdap vaccines (≤6% of eligible patients) were given to non-pregnant patients in either intervention or control practices at any time during the study. CONCLUSION In this cluster randomized trial designed to increase vaccination uptake, both intervention and control practices showed improved vaccination of pregnant but not non-pregnant patients. Future work should focus on tailoring evidence-based immunization practices or developing new approaches to specifically fit busy ob-gyn offices.",2019,"Both intervention and control practices increased to 51% in Year 2, representing an increase of 33% for intervention practices and 29% for control practices, consistent with a change in Tdap recommendations.","['pregnant women and these', 'obstetrics/gynecology settings', 'non-pregnant women', 'pregnant but not non-pregnant patients', '9 private ob-gyn practices in Colorado from 9/2011 to 5/2014']","['Tdap vaccines', 'Tdap vaccine', 'vaccines plus human papillomavirus (HPV) vaccine', 'immunization champions, staff/provider trainings, assistance with vaccine purchasing/management, identification of eligible patients, standing order implementation, chart review/feedback, and patient education materials', 'diphtheria-acellular pertussis (Tdap) vaccines', 'influenza vaccine', 'multimodal intervention']",['receipt of influenza and Tdap vaccines'],"[{'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C0018417', 'cui_str': 'Gynecology'}, {'cui': 'C0549206', 'cui_str': 'Pregnancy not delivered'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4521534', 'cui_str': 'US Military enlisted E1'}, {'cui': 'C0009399', 'cui_str': 'Colorado'}]","[{'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1512511', 'cui_str': 'HPV Vaccines'}, {'cui': 'C0020971', 'cui_str': 'Sensitization, Immunologic'}, {'cui': 'C2700616', 'cui_str': 'Manpowers'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0020792', 'cui_str': 'Identification'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4277736', 'cui_str': 'Standing Orders'}, {'cui': 'C0541653', 'cui_str': 'Chart review'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0030688', 'cui_str': 'Education of Patients'}, {'cui': 'C0520510', 'cui_str': 'Material (attribute)'}, {'cui': 'C0012546', 'cui_str': 'Corynebacterium diphtheriae Infection'}, {'cui': 'C0982332', 'cui_str': 'acellular pertussis vaccine, inactivated'}, {'cui': 'C0021403', 'cui_str': 'Influenza Vaccines'}]","[{'cui': 'C0021400', 'cui_str': 'Influenza, Human'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}]",9.0,0.0895034,"Both intervention and control practices increased to 51% in Year 2, representing an increase of 33% for intervention practices and 29% for control practices, consistent with a change in Tdap recommendations.","[{'ForeName': 'Sean T', 'Initials': 'ST', 'LastName': ""O'Leary"", 'Affiliation': ""Adult and Child Consortium for Outcomes Research and Delivery Science Program (ACCORDS), Children's Hospital Colorado, University of Colorado Denver, USA; Department of Pediatrics, University of Colorado School of Medicine, Anschutz Medical Campus, Aurora, CO, USA. Electronic address: sean.oleary@ucdenver.edu.""}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Pyrzanowski', 'Affiliation': ""Adult and Child Consortium for Outcomes Research and Delivery Science Program (ACCORDS), Children's Hospital Colorado, University of Colorado Denver, USA.""}, {'ForeName': 'Sarah E', 'Initials': 'SE', 'LastName': 'Brewer', 'Affiliation': ""Adult and Child Consortium for Outcomes Research and Delivery Science Program (ACCORDS), Children's Hospital Colorado, University of Colorado Denver, USA.""}, {'ForeName': 'Carter', 'Initials': 'C', 'LastName': 'Sevick', 'Affiliation': ""Adult and Child Consortium for Outcomes Research and Delivery Science Program (ACCORDS), Children's Hospital Colorado, University of Colorado Denver, USA.""}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Miriam Dickinson', 'Affiliation': ""Adult and Child Consortium for Outcomes Research and Delivery Science Program (ACCORDS), Children's Hospital Colorado, University of Colorado Denver, USA; Department of Family Medicine, University of Colorado School of Medicine, Anschutz Medical Campus, Aurora, CO, USA.""}, {'ForeName': 'Amanda F', 'Initials': 'AF', 'LastName': 'Dempsey', 'Affiliation': ""Adult and Child Consortium for Outcomes Research and Delivery Science Program (ACCORDS), Children's Hospital Colorado, University of Colorado Denver, USA; Department of Pediatrics, University of Colorado School of Medicine, Anschutz Medical Campus, Aurora, CO, USA.""}]",Vaccine,['10.1016/j.vaccine.2019.05.034'] 1006,30872105,A Diet Low in Red and Processed Meat Does Not Reduce Rate of Crohn's Disease Flares.,"BACKGROUND & AIMS Diet may be an important factor in the progression of Crohn's disease (CD). We performed a randomized controlled trial to determine whether reduced consumption of red and processed meats decreases the risk of symptomatic relapse of CD, analyzing results from the Food and Crohn's Disease Exacerbation Study (FACES) trial. METHODS Adults with CD were recruited into the FACES trial from IBD Partners, an Internet-based cohort of patients with inflammatory bowel disease, from November 2013 through June 2015. Individuals who were in remission (CD activity index [sCDAI] scores of ≤150), had completed a biannual survey, and reported consumption of red meat at least once weekly were randomly assigned to groups that consumed a minimum of 2 servings/week of red or processed meat (high meat, n = 118) or not more than 1 serving per month (low meat, n = 96) for 49 weeks. The primary outcome was relapse of CD, defined as increase in sCDAI score by ≥70 points and to >150 or a need for CD surgery or new CD medication. A secondary outcome, moderate or severe relapse, was based on an increase in sCDAI to >219. RESULTS During the trial, the high-meat groups reported consumption of 2 or more servings of red or processed meat during 98.5% of observed weeks compared with 18.8% of weeks for the low-meat group. Any and moderate to severe relapse occurred in 62% of participants in the high-meat group and 42% of participants in the low-meat group. There were no significant differences in time to any (P = .61) or moderate/severe (P = .50) relapse. CONCLUSIONS In an analysis of data from the FACES trial, we found that among patients with CD in remission, level of red and processed meat consumption was not associated with time to symptomatic relapse. ClinicalTrials.gov, Number: NCT0192673.",2019,Any and moderate to severe relapse occurred in 62% of participants in the high-meat group and 42% of participants in the low-meat group.,"['Adults with CD were recruited into the FACES trial from IBD Partners, an Internet-based cohort of patients with inflammatory bowel disease, from November 2013 through June 2015', 'Individuals who were in remission (CD activity index [sCDAI] scores of ≤150), had completed a biannual survey, and reported consumption of red meat at least once weekly']",[],"['relapse of CD', 'moderate or severe relapse', ""Rate of Crohn's Disease Flares"", 'consumption of 2 or more servings of red or processed meat', 'sCDAI score', 'remission, level of red and processed meat consumption', 'severe relapse']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C0021390', 'cui_str': 'Inflammatory Bowel Diseases'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0452848', 'cui_str': 'Red Meat'}, {'cui': 'C0558293', 'cui_str': 'Once a week (qualifier value)'}]",[],"[{'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0156147', 'cui_str': 'Colitis, Granulomatous'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0332575', 'cui_str': 'Red color (finding)'}, {'cui': 'C0452956', 'cui_str': 'Processed meat (substance)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",,0.214047,Any and moderate to severe relapse occurred in 62% of participants in the high-meat group and 42% of participants in the low-meat group.,"[{'ForeName': 'Lindsey', 'Initials': 'L', 'LastName': 'Albenberg', 'Affiliation': ""Division of Gastroenterology, Hepatology, and Nutrition, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania.""}, {'ForeName': 'Colleen M', 'Initials': 'CM', 'LastName': 'Brensinger', 'Affiliation': 'Center for Clinical Epidemiology and Biostatistics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Qufei', 'Initials': 'Q', 'LastName': 'Wu', 'Affiliation': 'Division of Gastroenterology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Gilroy', 'Affiliation': 'Division of Gastroenterology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Kappelman', 'Affiliation': 'Center for Clinical Epidemiology and Biostatistics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Robert S', 'Initials': 'RS', 'LastName': 'Sandler', 'Affiliation': 'Center for Gastrointestinal Biology and Disease, University of North Carolina, Chapel Hill, North Carolina.'}, {'ForeName': 'James D', 'Initials': 'JD', 'LastName': 'Lewis', 'Affiliation': 'Center for Clinical Epidemiology and Biostatistics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania; Division of Gastroenterology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania. Electronic address: lewisjd@pennmedicine.upenn.edu.'}]",Gastroenterology,['10.1053/j.gastro.2019.03.015'] 1007,31106659,Randomized Study of the Effect of Vitamin D and Omega-3 Fatty Acids Cosupplementation as Adjuvant Chemotherapy on Inflammation and Nutritional Status in Colorectal Cancer Patients.,"This study aimed to evaluate the effects of vitamin D 3 and omega-3 fatty acids cosupplementation on inflammation and nutritional status in colorectal cancer patients. In this clinical trial, 81 colorectal cancer patients were randomly assigned into four groups: (1) control group: receiving a vitamin D 3 placebo weekly + omega-3 fatty acid placebo capsules daily; (2) omega-3 fatty acid group: receiving 2 omega-3 fatty acid capsules (each capsule containing 330 mg of omega-3 fatty acids) daily + a vitamin D 3 placebo weekly; (3) vitamin D group: receiving a 50,000 IU vitamin D 3 soft gel weekly + 2 omega-3 fatty acid placebo capsules daily; (4) cosupplementation group: receiving a 50,000 IU vitamin D 3 soft gel weekly + 2 omega-3 fatty acids capsules daily for 8 weeks. Before and after the intervention, height, weight, fat-free mass (FFM), serum levels of 25(OH)D, tumor necrosis factor alpha (TNF-α), and interleukin 6 (IL-6), C-reactive protein (CRP), and albumin, were measured. After 8 weeks of intervention, patients who received combined vitamin D 3 and omega-3 fatty acids supplements compared with omega-3, vitamin D 3 , and placebo groups had significantly decreased CRP and TNF-α. In addition, serum level of IL-6 was decreased significantly in omega-3, vitamin D 3 , and cosupplementation groups compared with baseline. Regarding nutritional status, weight, BMI, and FFM% were increased significantly in vitamin D 3 , omega-3, and cosupplementation groups at the end of the intervention. Vitamin D 3 plus omega-3 fatty acids cosupplementation in colorectal cancer patients has beneficial impacts on inflammation and nutritional status.",2020,"Regarding nutritional status, weight, BMI, and FFM% were increased significantly in vitamin D 3 , omega-3, and cosupplementation groups at the end of the intervention.","['Colorectal Cancer Patients', 'colorectal cancer patients', '81 colorectal cancer patients']","['Vitamin D 3 plus omega-3 fatty acids cosupplementation', 'vitamin D 3 and omega-3 fatty acids cosupplementation', 'Vitamin D and Omega-3 Fatty Acids Cosupplementation', 'control group: receiving a vitamin D 3 placebo weekly\u2009+\u2009omega-3 fatty acid placebo capsules daily; (2) omega-3 fatty acid group: receiving 2 omega-3 fatty acid capsules (each capsule containing 330\u2009mg of omega-3 fatty acids) daily\u2009+\u2009a vitamin D 3 placebo weekly; (3) vitamin D group: receiving a 50,000\u2009IU vitamin D 3 soft gel weekly + 2 omega-3 fatty acid placebo capsules daily; (4) cosupplementation group: receiving a 50,000\u2009IU vitamin D 3 soft gel weekly + 2 omega-3 fatty acids capsules daily for 8\u2009weeks', 'combined vitamin D 3 and omega-3 fatty acids supplements compared with omega-3, vitamin D 3 , and placebo']","['CRP and TNF-α', 'serum level of IL-6', 'nutritional status, weight, BMI, and FFM', 'Inflammation and Nutritional Status', 'inflammation and nutritional status', 'height, weight, fat-free mass (FFM), serum levels of 25(OH)D, tumor necrosis factor alpha (TNF-α), and interleukin 6 (IL-6), C-reactive protein (CRP), and albumin']","[{'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4319574', 'cui_str': 'Capsule'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C4517719', 'cui_str': '330 (qualifier value)'}, {'cui': 'C0205358', 'cui_str': 'Soft (qualifier value)'}, {'cui': 'C0017243', 'cui_str': 'Gel (basic dose form)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C1719844', 'cui_str': 'Greek letter omega'}]","[{'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0392209', 'cui_str': 'Nutrition Status'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0424679', 'cui_str': 'Fat-free mass (observable entity)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C3711292', 'cui_str': '68Ga-albumin'}]",81.0,0.0704157,"Regarding nutritional status, weight, BMI, and FFM% were increased significantly in vitamin D 3 , omega-3, and cosupplementation groups at the end of the intervention.","[{'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Haidari', 'Affiliation': 'Department of Nutrition, Nutrition and Metabolic Diseases Research Center, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Behnaz', 'Initials': 'B', 'LastName': 'Abiri', 'Affiliation': 'Department of Nutrition, Faculty of Paramedicine, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Masood', 'Initials': 'M', 'LastName': 'Iravani', 'Affiliation': 'Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Kambiz', 'Initials': 'K', 'LastName': 'Ahmadi-Angali', 'Affiliation': 'Faculty of Public Health, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Mohammadreza', 'Initials': 'M', 'LastName': 'Vafa', 'Affiliation': 'Department of Nutrition, School of Public Health, Iran University of Medical Sciences, Tehran, Iran.'}]",Journal of dietary supplements,['10.1080/19390211.2019.1600096'] 1008,31095461,Effect of acute dietary nitrate supplementation on sympathetic vasoconstriction at rest and during exercise.,"Dietary nitrate ( N O 3 - ) supplementation has been shown to reduce resting blood pressure. However, the mechanism responsible for the reduction in blood pressure has not been identified. Dietary N O 3 - supplementation may increase nitric oxide (NO) bioavailability, and NO has been shown to inhibit sympathetic vasoconstriction in resting and contracting skeletal muscle. Therefore, the purpose of this study was to investigate the hypothesis that acute dietary N O 3 - supplementation would attenuate sympathetic vasoconstrictor responsiveness at rest and during exercise. In a double-blind randomized crossover design, 12 men (23 ± 5 yr) performed a cold-pressor test (CPT) at rest and during moderate- and heavy-intensity alternate-leg knee-extension exercise after consumption of N O 3 - rich beetroot juice (~12.9 mmol N O 3 - ) or a N O 3 - -depleted placebo (~0.13 mmol N O 3 - ). Venous blood was sampled before and 2.5 h after the consumption of beetroot juice for the measurement of total plasma nitrite/ N O 3 - [NO x ]. Beat-by-beat blood pressure was measured by Finometer. Leg blood flow was measured at the femoral artery via Doppler ultrasound, and leg vascular conductance (LVC) was calculated. Sympathetic vasoconstrictor responsiveness was calculated as the percentage decrease in LVC in response to the CPT. Total plasma [NO x ] was greater ( P < 0.001) in the N O 3 - (285 ± 120 µM) compared with the placebo (65 ± 30 µM) condition. However, mean arterial blood pressure and plasma catecholamines were not different ( P > 0.05) between N O 3 - and placebo conditions at rest or during moderate- and heavy-intensity exercise. Sympathetic vasoconstrictor responsiveness (Δ% LVC) was not different ( P > 0.05) between N O 3 - and placebo conditions at rest ( N O 3 - : -33 ± 10%; placebo: -35 ± 11%) or during moderate ( N O 3 - : -18 ± 8%; placebo: -20 ± 10%)- and heavy ( N O 3 - : -12 ± 8%; placebo: -11 ± 9%)-intensity exercise. These data demonstrate that acute dietary N O 3 - supplementation does not alter sympathetic vasoconstrictor responsiveness at rest or during exercise in young healthy males. NEW & NOTEWORTHY Dietary nitrate may increase nitric oxide bioavailability, and nitric oxide has been shown to attenuate sympathetic vasoconstriction in resting and contracting skeletal muscle and enhance functional sympatholysis. However, the effect of dietary nitrate on sympathetic vasoconstrictor responsiveness is unknown. Acute dietary nitrate supplementation did not alter blood pressure or sympathetic vasoconstrictor responsiveness at rest or during exercise in young healthy males.",2019,Sympathetic vasoconstrictor responsiveness (Δ% LVC) was not different ( P > 0.05) between N O,"['12 men (23\u2009±\u20095 yr) performed a', 'young healthy males']","['Acute dietary nitrate supplementation', 'placebo', 'dietary nitrate', 'acute dietary nitrate supplementation', 'placebo: -20\u2009±\u200910%)- and heavy ( N O 3 - : -12\u2009±\u20098%; placebo: -11\u2009±\u20099%)-intensity exercise', 'Dietary nitrate ( N O 3 - ) supplementation', 'cold-pressor test (CPT) at rest and during moderate- and heavy-intensity alternate-leg knee-extension exercise after consumption of N O 3 - rich beetroot juice (~12.9 mmol N O 3 - ) or a N O 3 - -depleted placebo']","['blood pressure', 'Total plasma [NO', 'Sympathetic vasoconstrictor responsiveness', 'leg vascular conductance (LVC', 'Beat-by-beat blood pressure', 'Leg blood flow', 'resting blood pressure', 'Venous blood', 'nitric oxide (NO) bioavailability', 'sympathetic vasoconstrictor responsiveness', 'sympathetic vasoconstriction', 'mean arterial blood pressure and plasma catecholamines', 'blood pressure or sympathetic vasoconstrictor responsiveness']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}]","[{'cui': 'C0028125', 'cui_str': 'Nitrates'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0439539', 'cui_str': 'Heavy sensation quality'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0444689', 'cui_str': 'Cold pressor test (procedure)'}, {'cui': 'C0443144', 'cui_str': 'At rest (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0332270', 'cui_str': 'Alternating (qualifier value)'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0699759', 'cui_str': 'Wealthy (finding)'}, {'cui': 'C0453112', 'cui_str': 'Beetroot (substance)'}, {'cui': 'C1268568', 'cui_str': 'Juice'}, {'cui': 'C0439190', 'cui_str': 'mmol'}]","[{'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0042397', 'cui_str': 'Vasoactive Agonists'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow, function (observable entity)'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0229667', 'cui_str': 'VB - Venous blood'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0005508', 'cui_str': 'Bioavailability'}, {'cui': 'C1456863', 'cui_str': 'Vasoconstriction'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1272641', 'cui_str': 'Arterial Tension'}, {'cui': 'C0857652', 'cui_str': 'Plasma catecholamines'}]",,0.125454,Sympathetic vasoconstrictor responsiveness (Δ% LVC) was not different ( P > 0.05) between N O,"[{'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'de Vries', 'Affiliation': 'Faculty of Kinesiology, Sport, and Recreation, University of Alberta , Edmonton, Alberta , Canada.'}, {'ForeName': 'Darren S', 'Initials': 'DS', 'LastName': 'DeLorey', 'Affiliation': 'Faculty of Kinesiology, Sport, and Recreation, University of Alberta , Edmonton, Alberta , Canada.'}]","Journal of applied physiology (Bethesda, Md. : 1985)",['10.1152/japplphysiol.01053.2018'] 1009,31763982,Influence of final kissing balloon inflation on long-term outcomes after PCI of distal left main bifurcation lesions in the EXCEL trial.,"AIMS The impact of final kissing balloon inflation (FKBI) after percutaneous coronary intervention (PCI) of bifurcation lesions on long-term clinical outcomes remains controversial. We sought to determine the impact of FKBI on four-year outcomes after PCI of distal left main (LM) bifurcation lesions. METHODS AND RESULTS The EXCEL trial compared PCI with everolimus-eluting stents and coronary artery bypass graft surgery (CABG) in patients with left main (LM) disease. We examined four-year clinical outcomes after PCI of distal LM bifurcation lesions according to use of FKBI. The primary endpoint was the composite rate of death, myocardial infarction (MI), or stroke. The major secondary endpoint was the composite rate of death, MI, stroke, or ischaemia-driven revascularisation (IDR). Among 948 patients randomised to PCI, 759 had distal LM lesions treated, 430 of which were treated with one stent and 329 of which were treated with two or more stents. The four-year rates of the primary and major secondary endpoints were similar with versus without FKBI in both the one-stent and ≥2-stent groups in both unadjusted and adjusted analyses. CONCLUSIONS In the EXCEL trial, the performance of FKBI after PCI of distal LM bifurcation lesions was not associated with improved four-year clinical outcomes regardless of whether one stent or ≥2 stents were implanted.",2020,"The 4-year rates of the primary and major secondary endpoints were similar with versus without FKBI in both the 1-stent and ≥2-stent groups in both unadjusted and adjusted analyses. ","['948 patients randomized to PCI, 759 had distal LM lesions treated, 430 of which were treated with 1 stent and 329 of which were treated with 2 or more stents', 'patients with LM disease']","['FKBI', 'everolimus-eluting stents and coronary artery bypass graft surgery', 'Final Kissing Balloon Inflation']","['composite rate of death, myocardial infarction (MI), or stroke', 'composite rate of death, MI, stroke, or ischemia-driven revascularization (IDR', '4-year rates']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205108', 'cui_str': 'Distal (qualifier value)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0038257', 'cui_str': 'Stents'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0541315', 'cui_str': 'everolimus'}, {'cui': 'C0038257', 'cui_str': 'Stents'}, {'cui': 'C0010055', 'cui_str': 'Coronary Artery Bypass Grafting'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft (physical object)'}, {'cui': 'C1318493', 'cui_str': 'Inflation'}]","[{'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C0004379', 'cui_str': 'Drivings, Automobile'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]",948.0,0.165677,"The 4-year rates of the primary and major secondary endpoints were similar with versus without FKBI in both the 1-stent and ≥2-stent groups in both unadjusted and adjusted analyses. ","[{'ForeName': 'Annapoorna S', 'Initials': 'AS', 'LastName': 'Kini', 'Affiliation': 'Mount Sinai Hospital and Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'George D', 'Initials': 'GD', 'LastName': 'Dangas', 'Affiliation': ''}, {'ForeName': 'Usman', 'Initials': 'U', 'LastName': 'Baber', 'Affiliation': ''}, {'ForeName': 'Yuliya', 'Initials': 'Y', 'LastName': 'Vengrenyuk', 'Affiliation': ''}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Kandzari', 'Affiliation': ''}, {'ForeName': 'Martin B', 'Initials': 'MB', 'LastName': 'Leon', 'Affiliation': ''}, {'ForeName': 'Marie-Claude', 'Initials': 'MC', 'LastName': 'Morice', 'Affiliation': ''}, {'ForeName': 'Patrick W', 'Initials': 'PW', 'LastName': 'Serruys', 'Affiliation': ''}, {'ForeName': 'A Pieter', 'Initials': 'AP', 'LastName': 'Kappetein', 'Affiliation': ''}, {'ForeName': 'Joseph F', 'Initials': 'JF', 'LastName': 'Sabik', 'Affiliation': ''}, {'ForeName': 'Ovidiu', 'Initials': 'O', 'LastName': 'Dressler', 'Affiliation': ''}, {'ForeName': 'Roxana', 'Initials': 'R', 'LastName': 'Mehran', 'Affiliation': ''}, {'ForeName': 'Samin K', 'Initials': 'SK', 'LastName': 'Sharma', 'Affiliation': ''}, {'ForeName': 'Gregg W', 'Initials': 'GW', 'LastName': 'Stone', 'Affiliation': ''}]",EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology,['10.4244/EIJ-D-19-00851'] 1010,31868201,"A modified low-protein infant formula supports adequate growth in healthy, term infants: a randomized, double-blind, equivalence trial.","BACKGROUND A high protein intake in early life is associated with a risk of obesity later in life. The essential amino acid requirements of formula-fed infants have been reassessed recently, enabling a reduction in total protein content and thus in protein intake. OBJECTIVES We aimed to assess the safety of an infant formula with a modified amino acid profile and a modified low-protein (mLP) content in healthy term-born infants. Outcomes were compared with a specifically designed control (CTRL) infant formula. METHODS In this double-blind, randomized controlled equivalence trial, infants received either mLP (1.7 g protein/100 kcal; n = 90) or CTRL formula (2.1 g protein/100 kcal; n = 88) from enrollment (age ≤ 45 d) to 6 mo of age. A breastfed group served as a reference (n = 67). Anthropometry and body composition were determined at baseline, 17 wk (including safety blood parameters), and 6 mo of age. The primary outcome was daily weight gain from enrollment up until the age of 17 wk (at an equivalence margin of ±3.0 g/d). RESULTS Weight gain from baseline (mean ± SD age: 31 ± 9 d) up to the age of 17 wk was equivalent between the mLP and CTRL formula groups (27.9 and 28.8 g/d, respectively; difference: -0.86 g/d; 90% CI: -2.36, 0.63 g/d). No differences in other growth parameters, body composition, or in adverse events were observed. Urea was significantly lower in the mLP formula group than in the CTRL formula group (-0.74 mmol/L; 95% CI: -0.97, -0.51 mmol/L; P < 0.001). Growth rates, fat mass, fat-free mass, and several essential amino acids were significantly higher in both formula groups than in the breastfed reference group. CONCLUSIONS Feeding an infant formula with a modified amino acid profile and a lower protein content from an average age of 1 mo until the age of 6 mo is safe and supports an adequate growth, similar to that of infants consuming CTRL formula. This trial was registered at www.trialregister.nl as Trial NL4677.",2020,"Growth rates, fat mass, fat-free mass, and several essential amino acids were significantly higher in both formula groups than in the breastfed reference group. ","['healthy, term infants', 'SD age: 31\xa0±\xa09 d) up to the age of 17 wk', 'healthy term-born infants']","['mLP', 'modified low-protein infant formula', 'infant formula with a modified amino acid profile and a modified low-protein (mLP']","['Anthropometry and body composition', 'daily weight gain', 'Weight gain', 'Growth rates, fat mass, fat-free mass, and several essential amino acids', 'Urea', 'growth parameters, body composition, or in adverse events']","[{'cui': 'C0456128', 'cui_str': 'Term infant (finding)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0021270', 'cui_str': 'Infant'}]","[{'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0150589', 'cui_str': 'Baby Formula'}, {'cui': 'C3539946', 'cui_str': 'Amino acids'}]","[{'cui': 'C0003188', 'cui_str': 'Anthropometry'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0043094', 'cui_str': 'Weight Gain'}, {'cui': 'C0449249', 'cui_str': 'Growth rate (attribute)'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0424679', 'cui_str': 'Fat-free mass (observable entity)'}, {'cui': 'C0002525', 'cui_str': 'Amino Acids, Essential'}, {'cui': 'C0070525', 'cui_str': 'phenacemide'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.46606,"Growth rates, fat mass, fat-free mass, and several essential amino acids were significantly higher in both formula groups than in the breastfed reference group. ","[{'ForeName': 'Stefanie M P', 'Initials': 'SMP', 'LastName': 'Kouwenhoven', 'Affiliation': ""Emma Children's Hospital, Amsterdam UMC, Vije Universiteit Amsterdam, University of Amsterdam, Amsterdam, Netherlands.""}, {'ForeName': 'Nadja', 'Initials': 'N', 'LastName': 'Antl', 'Affiliation': ""Division of Metabolic and Nutritional Medicine, LMU - Ludwig-Maximilians-Universität Munich, University of Munich Medical Centre, Dr. von Hauner Children's Hospital, Munich, Germany.""}, {'ForeName': 'Martijn J J', 'Initials': 'MJJ', 'LastName': 'Finken', 'Affiliation': ""Department of Pediatric Endocrinology, Emma Children's Hospital, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, Netherlands.""}, {'ForeName': 'Jos W R', 'Initials': 'JWR', 'LastName': 'Twisk', 'Affiliation': 'Epidemiology and Biostatistics, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Eline M', 'Initials': 'EM', 'LastName': 'van der Beek', 'Affiliation': 'Danone Nutricia Research, Utrecht, Netherlands.'}, {'ForeName': 'Marieke', 'Initials': 'M', 'LastName': 'Abrahamse-Berkeveld', 'Affiliation': 'Danone Nutricia Research, Utrecht, Netherlands.'}, {'ForeName': 'Bert J M', 'Initials': 'BJM', 'LastName': 'van de Heijning', 'Affiliation': 'Danone Nutricia Research, Utrecht, Netherlands.'}, {'ForeName': 'Henk', 'Initials': 'H', 'LastName': 'Schierbeek', 'Affiliation': 'Stable Isotope Laboratory, Amsterdam UMC, University of Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Lesca M', 'Initials': 'LM', 'LastName': 'Holdt', 'Affiliation': 'Institute of Laboratory Medicine, LMU - Ludwig-Maximilians-Universität Munich, University of Munich Medical Centre, Munich, Germany.'}, {'ForeName': 'Johannes B', 'Initials': 'JB', 'LastName': 'van Goudoever', 'Affiliation': ""Emma Children's Hospital, Amsterdam UMC, Vije Universiteit Amsterdam, University of Amsterdam, Amsterdam, Netherlands.""}, {'ForeName': 'Berthold V', 'Initials': 'BV', 'LastName': 'Koletzko', 'Affiliation': ""Division of Metabolic and Nutritional Medicine, LMU - Ludwig-Maximilians-Universität Munich, University of Munich Medical Centre, Dr. von Hauner Children's Hospital, Munich, Germany.""}]",The American journal of clinical nutrition,['10.1093/ajcn/nqz308'] 1011,31155161,A randomized controlled feasibility trial of a home-based walking behavior-change intervention for people with intermittent claudication.,"Walking treatment is recommended for improving intermittent claudication (IC), a debilitating symptom of leg pain caused by peripheral arterial disease. However, center-based exercise programs offered in a community or hospital setting are often not implemented or adhered to. We developed a home-delivered behavior-change intervention, MOtivating Structured walking Activity in Intermittent Claudication (MOSAIC), to increase walking in people with IC. A feasibility randomized controlled trial with nested qualitative interviews involving a subsample of trial participants was conducted. Feasibility criteria evaluated participant recruitment and retention; suitability of proposed outcome measures; and acceptability and adherence to the intervention and trial. Participants (adults aged ≥18 years diagnosed with IC identified from vascular outpatient clinics) were randomized 1:1 to receive MOSAIC treatment (two 60-minute home-based sessions and two 20-minute booster telephone calls incorporating behavior-change techniques) or an attention-control comparison. Outcomes (baseline and 16-week follow-up) included the 6-minute walking distance (meters), pedometer-assessed daily walking activity (steps/d), health-related quality of life, physical functioning, and beliefs about walking treatment, peripheral arterial disease, and self-regulatory processes. Twenty-four participants (mean age: 66.8 ± 9.4 years, 79% male) were included. Feasibility criteria achieved were recruitment rate (25%), participant retention (92%), and adherence to assigned treatment or attention-control sessions (71%). Missing data rates were <10% for all outcomes except for baseline daily walking activity (36%). The trial protocol and interventions were acceptable to participants and the clinician. In conclusion, the MOSAIC trial was feasible to conduct, with the exception of high missing pedometer data. The intervention is an acceptable approach to facilitate walking among people with IC.",2019,"Feasibility criteria achieved were recruitment rate (25%), participant retention (92%), and adherence to assigned treatment or attention-control sessions (71%).","['people with intermittent claudication', 'Participants (adults aged ≥18\xa0years diagnosed with IC identified from vascular outpatient clinics', 'Twenty-four participants (mean age: 66.8\xa0±\xa09.4\xa0years, 79% male) were included', 'people with IC']","['MOSAIC treatment (two 60-minute home-based sessions and two 20-minute booster telephone calls incorporating behavior-change techniques) or an attention-control comparison', 'home-based walking behavior-change intervention', 'home-delivered behavior-change intervention, MOtivating Structured walking Activity in Intermittent Claudication (MOSAIC']","['acceptability and adherence', '6-minute walking distance (meters), pedometer-assessed daily walking activity (steps/d), health-related quality of life, physical functioning, and beliefs about walking treatment, peripheral arterial disease, and self-regulatory processes']","[{'cui': 'C0021775', 'cui_str': 'Intermittent Claudication'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0002424', 'cui_str': 'Outpatient Clinics'}, {'cui': 'C3715070', 'cui_str': '24 (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4517844', 'cui_str': '66.8'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C0439750', 'cui_str': 'Mosaic (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C3853333', 'cui_str': 'Sixty minutes'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C1697762', 'cui_str': 'Booster'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0021775', 'cui_str': 'Intermittent Claudication'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1704436', 'cui_str': 'Peripheral Artery Disease'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C4521054', 'cui_str': 'Process (qualifier value)'}]",,0.160558,"Feasibility criteria achieved were recruitment rate (25%), participant retention (92%), and adherence to assigned treatment or attention-control sessions (71%).","[{'ForeName': 'Melissa N', 'Initials': 'MN', 'LastName': 'Galea Holmes', 'Affiliation': ""School of Population Health & Environmental Sciences, King's College London, Guy's Campus, London, United Kingdom. Electronic address: melissa.galea-holmes@ucl.ac.uk.""}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Weinman', 'Affiliation': ""Institute of Pharmaceutical Sciences, King's College London, King's College London, Waterloo Campus, London, United Kingdom.""}, {'ForeName': 'Lindsay M', 'Initials': 'LM', 'LastName': 'Bearne', 'Affiliation': ""School of Population Health & Environmental Sciences, King's College London, Guy's Campus, London, United Kingdom.""}]",Journal of vascular nursing : official publication of the Society for Peripheral Vascular Nursing,['10.1016/j.jvn.2018.11.001'] 1012,31727154,Blood-derived dendritic cell vaccinations induce immune responses that correlate with clinical outcome in patients with chemo-naive castration-resistant prostate cancer.,"BACKGROUND Clinical benefit of cellular immunotherapy has been shown in patients with castration-resistant prostate cancer (CRPC). We investigated the immunological response and clinical outcome of vaccination with blood-derived CD1c + myeloid dendritic cells (mDCs; cDC2) and plasmacytoid DCs (pDCs). METHODS In this randomized phase IIa trial, 21 chemo-naive CRPC patients received maximally 9 vaccinations with mature mDCs, pDCs or a combination of mDCs plus pDCs. DCs were stimulated with protamine/mRNA and loaded with tumor-associated antigens NY-ESO-1, MAGE-C2 and MUC1. Primary endpoint was the immunological response after DC vaccination, which was monitored in peripheral blood and in T cell cultures of biopsies of post-treatment delayed-type hypersensitivity-skin tests. Main secondary endpoints were safety, feasibility, radiological PFS (rPFS) and overall survival. Radiological responses were assessed by MRIs and contrast-enhanced 68 Ga-prostate-specific membrane antigen PET/CT, according to RECIST 1.1, PCWG2 criteria and immune-related response criteria. RESULTS Both tetramer/dextramer-positive (dm + ) and IFN-γ-producing (IFN-γ + ) antigen specific T cells were detected more frequently in skin biopsies of patients with radiological non-progressive disease (5/13 patients; 38%) compared to patients with progressive disease (0/8 patients; 0%). In these patients with vaccination enhanced dm + and IFN-γ + antigen-specific T cells median rPFS was 18.8 months (n = 5) vs. 5.1 months (n = 16) in patients without IFN-γ-producing antigen-specific T cells (p = 0.02). The overall median rPFS was 9.5 months. All DC vaccines were well tolerated with grade 1-2 toxicity. CONCLUSIONS Immunotherapy with blood-derived DC subsets was feasible and safe and induced functional antigen-specific T cells. The presence of functional antigen-specific T cells correlated with an improved clinical outcome. TRIAL REGISTRATION ClinicalTrials.gov identifier NCT02692976, registered 26 February 2016, retrospectively registered.",2019,In these patients with vaccination enhanced dm + and IFN-γ + antigen-specific T cells median rPFS was 18.8 months (n = 5) vs. 5.1 months (n = ,"['patients with chemo-naive castration-resistant prostate cancer', '21 chemo-naive CRPC patients received', 'patients without IFN-γ-producing antigen-specific T cells (p\xa0', 'patients with castration-resistant prostate cancer (CRPC', 'registered 26 February 2016, retrospectively registered']","['vaccination with blood-derived CD1c + myeloid dendritic cells (mDCs; cDC2', 'maximally 9 vaccinations with mature mDCs, pDCs or a combination of mDCs plus pDCs', 'Blood-derived dendritic cell vaccinations']","['functional antigen-specific T cells', 'feasible and safe and induced functional antigen-specific T cells', 'peripheral blood and in T cell cultures of biopsies of post-treatment delayed-type hypersensitivity-skin tests', 'safety, feasibility, radiological PFS (rPFS) and overall survival', 'dextramer-positive (dm + ) and IFN-γ-producing (IFN-γ + ) antigen specific T cells', 'overall median rPFS', 'immunological response after DC vaccination', 'Radiological responses']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1328504', 'cui_str': 'Castration-resistant prostate cancer'}, {'cui': 'C0003320', 'cui_str': 'Antigens'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0039194', 'cui_str': 'Thymus-Dependent Lymphocytes'}, {'cui': 'C0600375', 'cui_str': 'Registers'}]","[{'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0005768'}, {'cui': 'C0439677', 'cui_str': 'Myeloid (qualifier value)'}, {'cui': 'C0011306', 'cui_str': 'Dendritic Cells'}, {'cui': 'C0205286', 'cui_str': 'Mature (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0003320', 'cui_str': 'Antigens'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0039194', 'cui_str': 'Thymus-Dependent Lymphocytes'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood (substance)'}, {'cui': 'C0220814', 'cui_str': 'culture'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C3693346', 'cui_str': 'Delayed Treatment'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C3544362', 'cui_str': 'Hypersensitivity (SMQ)'}, {'cui': 'C0037296', 'cui_str': 'Skin Tests'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0205470', 'cui_str': 'Immunologic (qualifier value)'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]",68.0,0.397702,In these patients with vaccination enhanced dm + and IFN-γ + antigen-specific T cells median rPFS was 18.8 months (n = 5) vs. 5.1 months (n = ,"[{'ForeName': 'Harm', 'Initials': 'H', 'LastName': 'Westdorp', 'Affiliation': 'Department of Tumor Immunology and Medical Oncology, Radboud Institute for Molecular Life Sciences, Radboudumc, Geert Grooteplein 26, 6525 GA, Nijmegen, The Netherlands.'}, {'ForeName': 'Jeroen H A', 'Initials': 'JHA', 'LastName': 'Creemers', 'Affiliation': 'Department of Tumor Immunology and Medical Oncology, Radboud Institute for Molecular Life Sciences, Radboudumc, Geert Grooteplein 26, 6525 GA, Nijmegen, The Netherlands.'}, {'ForeName': 'Inge M', 'Initials': 'IM', 'LastName': 'van Oort', 'Affiliation': 'Department of Urology, Radboudumc, Nijmegen, The Netherlands.'}, {'ForeName': 'Gerty', 'Initials': 'G', 'LastName': 'Schreibelt', 'Affiliation': 'Department of Tumor Immunology and Medical Oncology, Radboud Institute for Molecular Life Sciences, Radboudumc, Geert Grooteplein 26, 6525 GA, Nijmegen, The Netherlands.'}, {'ForeName': 'Mark A J', 'Initials': 'MAJ', 'LastName': 'Gorris', 'Affiliation': 'Department of Tumor Immunology and Medical Oncology, Radboud Institute for Molecular Life Sciences, Radboudumc, Geert Grooteplein 26, 6525 GA, Nijmegen, The Netherlands.'}, {'ForeName': 'Niven', 'Initials': 'N', 'LastName': 'Mehra', 'Affiliation': 'Department of Tumor Immunology and Medical Oncology, Radboud Institute for Molecular Life Sciences, Radboudumc, Geert Grooteplein 26, 6525 GA, Nijmegen, The Netherlands.'}, {'ForeName': 'Michiel', 'Initials': 'M', 'LastName': 'Simons', 'Affiliation': 'Department of Pathology, Radboudumc, Nijmegen, The Netherlands.'}, {'ForeName': 'Anna L', 'Initials': 'AL', 'LastName': 'de Goede', 'Affiliation': 'Department of Pharmacy, Radboudumc, Nijmegen, The Netherlands.'}, {'ForeName': 'Michelle M', 'Initials': 'MM', 'LastName': 'van Rossum', 'Affiliation': 'Department of Dermatology, Radboudumc, Nijmegen, The Netherlands.'}, {'ForeName': 'Alexandra J', 'Initials': 'AJ', 'LastName': 'Croockewit', 'Affiliation': 'Department of Hematology, Radboudumc, Nijmegen, The Netherlands.'}, {'ForeName': 'Carl G', 'Initials': 'CG', 'LastName': 'Figdor', 'Affiliation': 'Department of Tumor Immunology and Medical Oncology, Radboud Institute for Molecular Life Sciences, Radboudumc, Geert Grooteplein 26, 6525 GA, Nijmegen, The Netherlands.'}, {'ForeName': 'J Alfred', 'Initials': 'JA', 'LastName': 'Witjes', 'Affiliation': 'Department of Urology, Radboudumc, Nijmegen, The Netherlands.'}, {'ForeName': 'Erik H J G', 'Initials': 'EHJG', 'LastName': 'Aarntzen', 'Affiliation': 'Department of Radiology and Nuclear Medicine, Radboudumc, Nijmegen, The Netherlands.'}, {'ForeName': 'Roel D M', 'Initials': 'RDM', 'LastName': 'Mus', 'Affiliation': 'Department of Radiology and Nuclear Medicine, Radboudumc, Nijmegen, The Netherlands.'}, {'ForeName': 'Mareke', 'Initials': 'M', 'LastName': 'Brüning', 'Affiliation': 'Miltenyi Biotec GmbH, Bergisch Gladbach, Germany.'}, {'ForeName': 'Katja', 'Initials': 'K', 'LastName': 'Petry', 'Affiliation': 'Miltenyi Biotec GmbH, Bergisch Gladbach, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Gotthardt', 'Affiliation': 'Department of Radiology and Nuclear Medicine, Radboudumc, Nijmegen, The Netherlands.'}, {'ForeName': 'Jelle O', 'Initials': 'JO', 'LastName': 'Barentsz', 'Affiliation': 'Department of Radiology and Nuclear Medicine, Radboudumc, Nijmegen, The Netherlands.'}, {'ForeName': 'I Jolanda M', 'Initials': 'IJM', 'LastName': 'de Vries', 'Affiliation': 'Department of Tumor Immunology and Medical Oncology, Radboud Institute for Molecular Life Sciences, Radboudumc, Geert Grooteplein 26, 6525 GA, Nijmegen, The Netherlands. Jolanda.deVries@radboudumc.nl.'}, {'ForeName': 'Winald R', 'Initials': 'WR', 'LastName': 'Gerritsen', 'Affiliation': 'Department of Tumor Immunology and Medical Oncology, Radboud Institute for Molecular Life Sciences, Radboudumc, Geert Grooteplein 26, 6525 GA, Nijmegen, The Netherlands.'}]",Journal for immunotherapy of cancer,['10.1186/s40425-019-0787-6'] 1013,31122893,Long-term treatment with recombinant human pentraxin 2 protein in patients with idiopathic pulmonary fibrosis: an open-label extension study.,"BACKGROUND Patients with idiopathic pulmonary fibrosis (IPF) treated with PRM-151, a recombinant human pentraxin 2 protein, in a phase 2 double-blind, randomised controlled trial had significantly reduced decline in percentage of predicted forced vital capacity (FVC) and stabilised 6-min walking distance compared with placebo over a 28-week period. Here we report the 76-week results of an open-label extension study. METHODS Patients who completed the 28-week double-blind period of the PRM-151-202 trial were eligible to participate in the open-label extension study. Patients previously enrolled in the PRM-151 group continued this treatment and those previously in the placebo group crossed over to PRM-151. All patients received PRM-151 in 28-week cycles with loading doses of 10 mg/kg by 60 min intravenous infusions on days 1, 3, and 5 in the first week of each cycle followed by one infusion of 10 mg/kg every 4 weeks. The primary objective of the open-label extension study was to assess the long-term safety and tolerability of PRM-151, which were assessed by analysing adverse events (AEs) up to week 76 in all patients who received at least one dose of PRM-151 during the open-label extension study. Exploratory efficacy analyses were done by assessing changes from baseline in percentage of predicted FVC and 6-min walking distance, with descriptive statistics to week 76 and with random-intercept mixed models to week 52. This study is registered with ClinicalTrials.gov, number NCT02550873, and with EudraCT, number 2014-004782-24. FINDINGS Of 116 patients who completed the double-blind treatment period, 111 entered the open-label extension study (74 from the PRM-151 group and 37 from the placebo group). 84 (76%) of 111 patients received concomitant IPF therapy (pirfenidone n=55 or nintedanib n=29). AEs were consistent with long-term IPF sequelae. 31 (28%) patients had serious AEs. Those occurring in two or more patients were pneumonia (six [5%] of 111), IPF exacerbation (four [4%]), IPF progression (four [4%]), and chest pain (two [2%]). 21 (19%) patients had severe AEs, of which IPF exacerbation and IPF progression each occurred in two (2%) patients. Two (2%) patients experienced life-threatening AEs (one had pneumonia and one had small-cell lung cancer extensive stage). A persistent treatment effect was observed for PRM-151 in patients who continued treatment, with a decline in percentage of predicted FVC of -3·6% per year and in 6-min walking distance of -10·5 m per year at week 52. In patients who started PRM-151 during the open-label extension study, compared with the slopes for placebo, decline reduced for percentage of predicted FVC (from -8·7% per year in weeks 0-28 to -0·9% per year in weeks 28-52, p<0·0001) and 6-min walking distance (from -54·9 m per year to -3·5 m per year, p=0·0224). INTERPRETATION Long-term treatment with PRM-151 was well tolerated and the effects on percentage of predicted FVC and 6-min walking distance were persistent on continuation and positive in patients who crossed over from placebo. These findings support further study of PRM-151 in larger populations of patients with IPF. FUNDING Promedior.",2019,"INTERPRETATION Long-term treatment with PRM-151 was well tolerated and the effects on percentage of predicted FVC and 6-min walking distance were persistent on continuation and positive in patients who crossed over from placebo.","['Patients who completed the 28-week double-blind period of the PRM-151-202 trial were eligible to participate in the open-label extension study', 'patients with IPF', '116 patients who completed the double-blind treatment period, 111 entered the open-label extension study (74 from the PRM-151 group and 37 from the placebo group', 'patients with idiopathic pulmonary fibrosis', 'Patients with idiopathic pulmonary fibrosis (IPF) treated with']","['concomitant IPF therapy (pirfenidone', 'recombinant human pentraxin 2 protein', 'placebo', 'PRM-151', 'PRM-151, a recombinant human pentraxin 2 protein']","['forced vital capacity (FVC) and stabilised 6-min walking distance', 'percentage of predicted FVC', '6-min walking distance', 'chest pain', 'IPF exacerbation and IPF progression each', 'IPF progression', 'serious AEs', 'IPF exacerbation']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C2976397', 'cui_str': 'PRM-151'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C4517541', 'cui_str': '116 (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4517538', 'cui_str': '111 (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0085786', 'cui_str': 'Alveolitis, Fibrosing'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}]","[{'cui': 'C0521115', 'cui_str': 'Simultaneous (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0298067', 'cui_str': 'pirfenidone'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2976397', 'cui_str': 'PRM-151'}]","[{'cui': 'C3714541', 'cui_str': 'Forced Vital Capacity'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0429886', 'cui_str': 'Walking distance (observable entity)'}, {'cui': 'C0008031', 'cui_str': 'Chest Pain'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}]",,0.312157,"INTERPRETATION Long-term treatment with PRM-151 was well tolerated and the effects on percentage of predicted FVC and 6-min walking distance were persistent on continuation and positive in patients who crossed over from placebo.","[{'ForeName': 'Ganesh', 'Initials': 'G', 'LastName': 'Raghu', 'Affiliation': 'Center for Interstitial Lung Diseases, Department of Medicine and Laboratory Medicine, University of Washington, Seattle, WA, USA. Electronic address: graghu@uw.edu.'}, {'ForeName': 'Bernt', 'Initials': 'B', 'LastName': 'van den Blink', 'Affiliation': 'Promedior, Lexington, MA, USA.'}, {'ForeName': 'Mark J', 'Initials': 'MJ', 'LastName': 'Hamblin', 'Affiliation': 'Pulmonary and Critical Care Medicine, University of Kansas Medical Center, Kansas City, KS, USA.'}, {'ForeName': 'A Whitney', 'Initials': 'AW', 'LastName': 'Brown', 'Affiliation': 'Inova Fairfax Hospital, Falls Church, VA, USA.'}, {'ForeName': 'Jeffrey A', 'Initials': 'JA', 'LastName': 'Golden', 'Affiliation': 'Department of Medicine, University of California, San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Lawrence A', 'Initials': 'LA', 'LastName': 'Ho', 'Affiliation': 'Center for Interstitial Lung Diseases, Department of Medicine and Laboratory Medicine, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Marlies S', 'Initials': 'MS', 'LastName': 'Wijsenbeek', 'Affiliation': 'Department of Respiratory Medicine, Erasmus MC, University Medical Center, Rotterdam, Netherlands.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Vasakova', 'Affiliation': 'Department of Respiratory Medicine, First Faculty of Medicine of Charles University and Thomayer Hospital, Prague, Czech Republic.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Pesci', 'Affiliation': 'School of Medicine and Surgery, University of Milano-Bicocca, Monza, Italy.'}, {'ForeName': 'Danielle E', 'Initials': 'DE', 'LastName': 'Antin-Ozerkis', 'Affiliation': 'Pulmonary, Critical Care, and Sleep Medicine, Yale School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Keith C', 'Initials': 'KC', 'LastName': 'Meyer', 'Affiliation': 'Department of Medicine, Division of Pulmonary and Critical Care, University of Wisconsin School of Medicine and Public Health, Madison, WI, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Kreuter', 'Affiliation': 'Center for Interstitial and Rare Lung Diseases, Thoraxklinik, University of Heidelberg and German Center for Lung, Research, Heidelberg, Germany.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Moran', 'Affiliation': 'Promedior, Lexington, MA, USA.'}, {'ForeName': 'Hugues', 'Initials': 'H', 'LastName': 'Santin-Janin', 'Affiliation': 'Venn Life Sciences, Paris, France.'}, {'ForeName': 'Francois', 'Initials': 'F', 'LastName': 'Aubin', 'Affiliation': 'Venn Life Sciences, Paris, France.'}, {'ForeName': 'Geert-Jan', 'Initials': 'GJ', 'LastName': 'Mulder', 'Affiliation': 'Promedior, Lexington, MA, USA.'}, {'ForeName': 'Renu', 'Initials': 'R', 'LastName': 'Gupta', 'Affiliation': 'Promedior, Lexington, MA, USA.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Richeldi', 'Affiliation': 'Fondazione Policlinico Universitario A Gemelli IRCCS, Università Cattolica del Sacro Cuore, Rome, Italy.'}]",The Lancet. Respiratory medicine,['10.1016/S2213-2600(19)30172-9'] 1014,31122894,"Eosinophil-guided corticosteroid therapy in patients admitted to hospital with COPD exacerbation (CORTICO-COP): a multicentre, randomised, controlled, open-label, non-inferiority trial.","BACKGROUND Treatment with systemic corticosteroids in patients with acute exacerbations of chronic obstructive pulmonary disease (COPD) is associated with debilitating adverse effects. Therefore, strategies to reduce systemic corticosteroid exposure are urgently required and might be offered by a personalised biomarker-guided approach to treatment. The aim of this study was to determine whether an algorithm based on blood eosinophil counts could safely reduce systemic corticosteroid exposure in patients admitted to hospital with acute exacerbations of COPD. METHODS We did a multicentre, randomised, controlled, open-label, non-inferiority trial at the respiratory departments of three different university-affiliated hospitals in Denmark. Eligible participants were patients included within 24h of admission to the participating sites, aged at least 40 years, with known airflow limitation (defined as a post-bronchodilator FEV 1 /forced vital capacity [FVC] ratio ≤0·70) and a specialist-verified diagnosis of COPD, who were designated to start on systemic corticosteroids by the respiratory medicine physician on duty. We randomly assigned patients (1:1) to either eosinophil-guided therapy or standard therapy with systemic corticosteroids. Both investigators and patients were aware of the group assignment. All patients received 80 mg of intravenous methylprednisolone on the first day. The eosinophil-guided group were from the second day given 37·5 mg of prednisolone oral tablet daily (for a maximum of up to 4 days) on days when their blood eosinophil count was at least 0·3 × 10 9 cells per L. On days when the eosinophil count was lower, prednisolone was not administered. If a patient was discharged during the treatment period, a treatment based on the last measured eosinophil count was prescribed for the remaining days within the 5-day period (last observation carried forward). The control group received 37·5 mg of prednisolone tablets daily from the second day for 4 days. The primary outcome was the number of days alive and out of hospital within 14 days after recruitment, assessed by intention to treat (ITT). Secondary outcomes included treatment failure at day 30 (ie, recurrence of acute exacerbation of COPD resulting in emergency room visits, admission to hospital, or need to intensify pharmacological treatment), number of deaths on day 30, and duration of treatment with systemic corticosteroids. The non-inferiority margin was 1·2 days (SD 3·8). This trial is registered at ClinicalTrials.gov, number NCT02857842, and was completed in January, 2019. FINDINGS Between Aug 3, 2016, and Sept 30, 2018, 159 patients in the eosinophil-guided group and 159 patients in the control group were included in the ITT analyses. There was no between-group difference for days alive and out of hospital within 14 days after recruitment: mean 8·9 days (95% CI 8·3-9·6) in the eosinophil-guided group versus 9·3 days (8·7-9·9) in the control group (absolute difference -0·4, 95% CI -1·3 to 0·5; p=0·34). Treatment failure at 30 days occurred in 42 (26%) of 159 patients in the eosinophil-guided group and 41 (26%) of 159 in the control group (difference 0·6%, 95% CI -9·0 to 10·3; p=0·90). At 30 days nine patients (6%) of 159 in the eosinophil-guided group and six (4%) of 159 in the control group had died (difference 1·9%, 95% CI -2·8 to 6·5; p=0·43). Median duration of systemic corticosteroid therapy was lower in the eosinophil-guided group: 2 days (IQR 1·0 to 3·0) compared with 5 days (5·0 to 5·0) in the control group, p<0·0001. INTERPRETATION Eosinophil-guided therapy was non-inferior compared with standard care for the number of days alive and out of hospital, and reduced the duration of systemic corticosteroid exposure, although we could not entirely exclude harm on some secondary outcome measures. Larger studies will help to determine the full safety profile of this strategy and its role in the management of COPD exacerbations. FUNDING The Danish Regions Medical Fund and the Danish Council for Independent Research.",2019,There was no between-group difference for days alive and out of hospital within 14 days after recruitment:,"['respiratory departments of three different university-affiliated hospitals in Denmark', 'patients with acute exacerbations of chronic obstructive pulmonary disease (COPD', 'patients admitted to hospital with acute exacerbations of COPD', 'Between Aug 3, 2016, and Sept 30, 2018, 159 patients in the eosinophil-guided group and 159 patients in the control group were included in the ITT analyses', 'Eligible participants were patients included within 24h of admission to the participating sites, aged at least 40 years, with known airflow limitation (defined as a post-bronchodilator FEV 1 /forced vital capacity [FVC] ratio ≤0·70) and a specialist-verified diagnosis of COPD, who were designated to start on systemic corticosteroids by the respiratory medicine physician on duty', 'patients admitted to hospital with COPD exacerbation (CORTICO-COP']","['37·5 mg of prednisolone', 'Eosinophil-guided corticosteroid therapy', 'eosinophil-guided therapy or standard therapy with systemic corticosteroids', 'systemic corticosteroids', 'intravenous methylprednisolone', 'Eosinophil-guided therapy was non-inferior compared with standard care', 'prednisolone']","['number of days alive and out of hospital within 14 days after recruitment, assessed by intention to treat (ITT', 'Treatment failure', 'treatment failure at day 30 (ie, recurrence of acute exacerbation of COPD resulting in emergency room visits, admission to hospital, or need to intensify pharmacological treatment), number of deaths on day 30, and duration of treatment with systemic corticosteroids', 'Median duration of systemic corticosteroid therapy', 'eosinophil count', 'died']","[{'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0340044', 'cui_str': 'Acute exacerbation of chronic obstructive airways disease (disorder)'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C0014467', 'cui_str': 'Eosinophil, segmented (cell)'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205309', 'cui_str': 'Known (qualifier value)'}, {'cui': 'C0231999', 'cui_str': 'Airflow, function (observable entity)'}, {'cui': 'C0449295', 'cui_str': 'Limitation (attribute)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0006280', 'cui_str': 'Bronchodilators'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0430511', 'cui_str': 'Vital capacity test (procedure)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0087009', 'cui_str': 'Specialists'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}, {'cui': 'C0034060', 'cui_str': 'Pneumology'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0740304', 'cui_str': 'COPD exacerbation'}]","[{'cui': 'C0032950', 'cui_str': 'prednisolone'}, {'cui': 'C0014467', 'cui_str': 'Eosinophil, segmented (cell)'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0025815', 'cui_str': 'Methylprednisolone'}, {'cui': 'C0542339', 'cui_str': 'Below (qualifier value)'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C2584946', 'cui_str': 'Alive'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0162643'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0340044', 'cui_str': 'Acute exacerbation of chronic obstructive airways disease (disorder)'}, {'cui': 'C0332294', 'cui_str': 'Resulting in (attribute)'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission (procedure)'}, {'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C0205464', 'cui_str': 'Pharmacologic (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0444921', 'cui_str': 'Duration of treatment (qualifier value)'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0200638', 'cui_str': 'Eosinophil count - observation'}, {'cui': 'C1546956', 'cui_str': 'Dead (finding)'}]",,0.360106,There was no between-group difference for days alive and out of hospital within 14 days after recruitment:,"[{'ForeName': 'Pradeesh', 'Initials': 'P', 'LastName': 'Sivapalan', 'Affiliation': 'Department of Internal Medicine, Respiratory Medicine Section, Herlev and Gentofte Hospital, University of Copenhagen, Hellerup, Denmark. Electronic address: pradeesh.s@dadlnet.dk.'}, {'ForeName': 'Therese S', 'Initials': 'TS', 'LastName': 'Lapperre', 'Affiliation': 'Department of Respiratory Medicine, Bispebjerg University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Janner', 'Affiliation': 'Department of Respiratory Medicine, Bispebjerg University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Rasmus R', 'Initials': 'RR', 'LastName': 'Laub', 'Affiliation': 'Department of Respiratory Medicine, Hvidovre University Hospital, Hvidovre, Denmark.'}, {'ForeName': 'Mia', 'Initials': 'M', 'LastName': 'Moberg', 'Affiliation': 'Department of Respiratory Medicine, Bispebjerg University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Charlotte S', 'Initials': 'CS', 'LastName': 'Bech', 'Affiliation': 'Department of Respiratory Medicine, Hvidovre University Hospital, Hvidovre, Denmark.'}, {'ForeName': 'Josefin', 'Initials': 'J', 'LastName': 'Eklöf', 'Affiliation': 'Department of Internal Medicine, Respiratory Medicine Section, Herlev and Gentofte Hospital, University of Copenhagen, Hellerup, Denmark.'}, {'ForeName': 'Freja S', 'Initials': 'FS', 'LastName': 'Holm', 'Affiliation': 'Department of Internal Medicine, Respiratory Medicine Section, Herlev and Gentofte Hospital, University of Copenhagen, Hellerup, Denmark.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Armbruster', 'Affiliation': 'Department of Internal Medicine, Respiratory Medicine Section, Herlev and Gentofte Hospital, University of Copenhagen, Hellerup, Denmark.'}, {'ForeName': 'Praleene', 'Initials': 'P', 'LastName': 'Sivapalan', 'Affiliation': 'Department of Internal Medicine, Respiratory Medicine Section, Herlev and Gentofte Hospital, University of Copenhagen, Hellerup, Denmark.'}, {'ForeName': 'Christiane', 'Initials': 'C', 'LastName': 'Mosbech', 'Affiliation': 'Department of Respiratory Medicine, Hvidovre University Hospital, Hvidovre, Denmark.'}, {'ForeName': 'Aras K M', 'Initials': 'AKM', 'LastName': 'Ali', 'Affiliation': 'Department of Respiratory Medicine, Bispebjerg University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'Seersholm', 'Affiliation': 'Department of Internal Medicine, Respiratory Medicine Section, Herlev and Gentofte Hospital, University of Copenhagen, Hellerup, Denmark.'}, {'ForeName': 'Jon T', 'Initials': 'JT', 'LastName': 'Wilcke', 'Affiliation': 'Department of Internal Medicine, Respiratory Medicine Section, Herlev and Gentofte Hospital, University of Copenhagen, Hellerup, Denmark.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Brøndum', 'Affiliation': 'Department of Respiratory Medicine, Hvidovre University Hospital, Hvidovre, Denmark.'}, {'ForeName': 'Tine P', 'Initials': 'TP', 'LastName': 'Sonne', 'Affiliation': 'Department of Internal Medicine, Respiratory Medicine Section, Herlev and Gentofte Hospital, University of Copenhagen, Hellerup, Denmark.'}, {'ForeName': 'Finn', 'Initials': 'F', 'LastName': 'Rønholt', 'Affiliation': 'Department of Internal Medicine, Herlev and Gentofte University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Helle F', 'Initials': 'HF', 'LastName': 'Andreassen', 'Affiliation': 'Department of Respiratory Medicine, Bispebjerg University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Charlotte S', 'Initials': 'CS', 'LastName': 'Ulrik', 'Affiliation': 'Department of Respiratory Medicine, Hvidovre University Hospital, Hvidovre, Denmark; Institute of Clinical Medicine, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Jørgen', 'Initials': 'J', 'LastName': 'Vestbo', 'Affiliation': 'Division of Infection, Immunity and Respiratory Medicine, University of Manchester, Manchester Academic Health Science Centre, Manchester, UK; North West Lung Centre, Manchester University NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'Jens-Ulrik S', 'Initials': 'JS', 'LastName': 'Jensen', 'Affiliation': 'Department of Internal Medicine, Respiratory Medicine Section, Herlev and Gentofte Hospital, University of Copenhagen, Hellerup, Denmark; Department of infectious diseases, Rigshospitalet, Copenhagen, Denmark.'}]",The Lancet. Respiratory medicine,['10.1016/S2213-2600(19)30176-6'] 1015,31747009,INTELLANCE 2/EORTC 1410 randomized phase II study of Depatux-M alone and with temozolomide vs temozolomide or lomustine in recurrent EGFR amplified glioblastoma.,"BACKGROUND Depatuxizumab mafodotin (Depatux-M) is a tumor-specific antibody-drug conjugate consisting of an antibody (ABT-806) directed against activated epidermal growth factor receptor (EGFR) and the toxin monomethylauristatin-F. We investigated Depatux-M in combination with temozolomide or as a single agent in a randomized controlled phase II trial in recurrent EGFR amplified glioblastoma. METHODS Eligible were patients with centrally confirmed EGFR amplified glioblastoma at first recurrence after chemo-irradiation with temozolomide. Patients were randomized to either Depatux-M 1.25 mg/kg every 2 weeks intravenously, or this treatment combined with temozolomide 150-200 mg/m2 day 1-5 every 4 weeks, or either lomustine or temozolomide. The primary endpoint of the study was overall survival. RESULTS Two hundred sixty patients were randomized. In the primary efficacy analysis with 199 events (median follow-up 15.0 mo), the hazard ratio (HR) for the combination arm compared with the control arm was 0.71 (95% CI = 0.50, 1.02; P = 0.062). The efficacy of Depatux-M monotherapy was comparable to that of the control arm (HR = 1.04, 95% CI = 0.73, 1.48; P = 0.83). The most frequent toxicity in Depatux-M treated patients was a reversible corneal epitheliopathy, occurring as grades 3-4 adverse events in 25-30% of patients. In the long-term follow-up analysis with median follow-up of 28.7 months, the HR for the comparison of the combination arm versus the control arm was 0.66 (95% CI = 0.48, 0.93). CONCLUSION This trial suggests a possible role for the use of Depatux-M in combination with temozolomide in EGFR amplified recurrent glioblastoma, especially in patients relapsing well after the end of first-line adjuvant temozolomide treatment. (NCT02343406).",2020,"The efficacy of Depatux-M monotherapy was comparable to that of the control arm (HR =1.04, 95%CI","['Eligible were patients with centrally confirmed EGFR amplified glioblastoma at first recurrence after chemo-irradiation with', '260 patients were randomized', 'recurrent EGFRamplified glioblastoma']","['Depatux-M alone and with temozolomide vs temozolomide or lomustine', 'Depatux-M', 'temozolomide', 'Depatux-M monotherapy', '2/EORTC', 'lomustine or temozolomide']","['reversible corneal epitheliopathy', 'hazard ratio (HR', 'overall survival']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0017636', 'cui_str': 'Astrocytoma, Grade IV'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C1282930', 'cui_str': 'Irradiation (physical force)'}, {'cui': 'C4517669', 'cui_str': 'Two hundred and sixty'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}]","[{'cui': 'C0076080', 'cui_str': 'temozolomide'}, {'cui': 'C0023972', 'cui_str': 'Lomustine'}]","[{'cui': 'C0205343', 'cui_str': 'Reversible (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",260.0,0.131555,"The efficacy of Depatux-M monotherapy was comparable to that of the control arm (HR =1.04, 95%CI","[{'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Van Den Bent', 'Affiliation': 'Brain Tumor Institute Erasmus Medical Center (MC) Cancer Institute, Rotterdam, the Netherlands.'}, {'ForeName': 'Marica', 'Initials': 'M', 'LastName': 'Eoli', 'Affiliation': 'Department of Neurology, Carlo Besta Institute, Milan, Italy.'}, {'ForeName': 'Juan Manuel', 'Initials': 'JM', 'LastName': 'Sepulveda', 'Affiliation': 'University Hospital 12 October, Madrid, Spain.'}, {'ForeName': 'Marion', 'Initials': 'M', 'LastName': 'Smits', 'Affiliation': 'Department of Radiology, Erasmus MC, Rotterdam, the Netherlands.'}, {'ForeName': 'Annemiek', 'Initials': 'A', 'LastName': 'Walenkamp', 'Affiliation': 'Department of Medical Oncology, University Medical Center Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Jean-Sebastian', 'Initials': 'JS', 'LastName': 'Frenel', 'Affiliation': 'Department of Medical Oncology, René Gauducheau Center for Cancer Care, Nantes, France.'}, {'ForeName': 'Enrico', 'Initials': 'E', 'LastName': 'Franceschi', 'Affiliation': 'Department of Medical Oncology, Local Health Unit Agency/Scientific Institute for Research, Hospitalization, and Healthcare (AUSL/IRCCS) Neurological Sciences, Bologna, Italy.'}, {'ForeName': 'Paul M', 'Initials': 'PM', 'LastName': 'Clement', 'Affiliation': 'Department of Medical Oncology, Leuven Cancer Institute, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Chinot', 'Affiliation': 'Department of Neuro-Oncology, Institute of Neurophysiopathology, Aix-Marseille University, Marseille, France.'}, {'ForeName': 'Filip', 'Initials': 'F', 'LastName': 'De Vos', 'Affiliation': 'Department of Medical Oncology, University Medical Center Utrecht, Utrecht, the Netherlands.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Whenham', 'Affiliation': 'Department of Medical Oncology, European Organisation for Research and Treatment of Cancer (EORTC), Brussels, Belgium.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Sanghera', 'Affiliation': 'University Hospitals Birmingham, Birmingham, UK.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Weller', 'Affiliation': 'Department of Neurology, University Hospital Zurich, Zurich, Switzerland.'}, {'ForeName': 'H J', 'Initials': 'HJ', 'LastName': 'Dubbink', 'Affiliation': 'Department of Pathology, Erasmus MC Cancer Institute, Rotterdam, the Netherlands.'}, {'ForeName': 'Pim', 'Initials': 'P', 'LastName': 'French', 'Affiliation': 'Brain Tumor Institute Erasmus Medical Center (MC) Cancer Institute, Rotterdam, the Netherlands.'}, {'ForeName': 'Jim', 'Initials': 'J', 'LastName': 'Looman', 'Affiliation': 'Abbvie, Chicago, IL USA.'}, {'ForeName': 'Jyotirmoy', 'Initials': 'J', 'LastName': 'Dey', 'Affiliation': 'Department of Neurology, Erasmus MC University Medical Center, Rotterdam, the Netherlands.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Krause', 'Affiliation': 'Abbvie, Chicago, IL USA.'}, {'ForeName': 'Pete', 'Initials': 'P', 'LastName': 'Ansell', 'Affiliation': 'Abbvie, Chicago, IL USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Nuyens', 'Affiliation': 'EORTC Headquarters, Brussels, Belgium.'}, {'ForeName': 'Maarten', 'Initials': 'M', 'LastName': 'Spruyt', 'Affiliation': 'Brain Tumor Institute Erasmus Medical Center (MC) Cancer Institute, Rotterdam, the Netherlands.'}, {'ForeName': 'Joana', 'Initials': 'J', 'LastName': 'Brilhante', 'Affiliation': 'EORTC Headquarters, Brussels, Belgium.'}, {'ForeName': 'Corneel', 'Initials': 'C', 'LastName': 'Coens', 'Affiliation': 'EORTC Headquarters, Brussels, Belgium.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Gorlia', 'Affiliation': 'EORTC Headquarters, Brussels, Belgium.'}, {'ForeName': 'Vassilis', 'Initials': 'V', 'LastName': 'Golfinopoulos', 'Affiliation': 'EORTC Headquarters, Brussels, Belgium.'}]",Neuro-oncology,['10.1093/neuonc/noz222'] 1016,31097283,The effect of electroacupuncture merged with rehabilitation for frozen shoulder syndrome: A single-blind randomized sham-acupuncture controlled study.,"PURPOSE Frozen shoulder syndrome (FSS) causes pain and reduces the range of motion in the shoulder joint. To investigate the short and medium-term effects of electroacupuncture in people with FSS, we evaluated the therapeutic effects of true and sham electroacupuncture on pain relief and improvement of shoulder function. METHODS In this randomized, single-blind controlled clinical trial, 21 subjects with FSS were randomly assigned to two groups: a true electroacupuncture group (TEAG) and a sham electroacupuncture group (SEAG). The two groups underwent 18 sessions of treatment over approximately 6-9 weeks and were then followed up at 1, 3, and 6 months. Their effectiveness for alleviating the intensity of shoulder pain was evaluated with a visual analog scale (VAS), while improved shoulder mobility was evaluated by the active range of motion (AROM) and passive range of motion (PROM), and shoulder functional ability was evaluated using the Shoulder Pain and Disability Index (SPADI). RESULTS It demonstrated that the TEAG or SEAG showed lasting effects at 1, 3, and 6 months, although with no significant difference between these two groups in the shoulder functional ability outcomes. However, the decline in the VAS occurred earlier in the TEAG than the SEAG. Also, there was much more improvement in AROM for flexion and abduction in the TEAG than the SEAG. An increase in the abduction angle after electroacupuncture and manual rehabilitation was also apparent. CONCLUSION These results suggest that electroacupuncture plus rehabilitation may provide earlier pain relief for patients with FSS and could be applied clinically.",2020,"Also, there was much more improvement in AROM for flexion and abduction in the TEAG than the SEAG.","['frozen shoulder syndrome', '21 subjects with FSS', 'people with FSS', 'patients with FSS']","['electroacupuncture', 'TEAG or SEAG', 'TEAG', 'electroacupuncture group (TEAG) and a sham electroacupuncture group (SEAG', 'electroacupuncture plus rehabilitation']","['Shoulder Pain and Disability Index (SPADI', 'visual analog scale (VAS), while improved shoulder mobility', 'intensity of shoulder pain', 'AROM for flexion and abduction', 'active range of motion (AROM) and passive range of motion (PROM), and shoulder functional ability', 'VAS', 'pain relief and improvement of shoulder function', 'shoulder functional ability outcomes', 'pain relief', 'abduction angle']","[{'cui': 'C0311223', 'cui_str': 'Shoulder Adhesive Capsulitis'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0013794', 'cui_str': 'Electroacupuncture'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}]","[{'cui': 'C0037011', 'cui_str': 'Shoulder Pain'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0037004', 'cui_str': 'Shoulder'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0231452', 'cui_str': 'Flexion, function (observable entity)'}, {'cui': 'C0231456', 'cui_str': 'Abduction, function (observable entity)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0080078', 'cui_str': 'Range of Motion'}, {'cui': 'C0079991', 'cui_str': 'Passive Range of Motion'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0451615', 'cui_str': 'Pain relief (procedure)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0205143', 'cui_str': 'Angular (qualifier value)'}]",21.0,0.105773,"Also, there was much more improvement in AROM for flexion and abduction in the TEAG than the SEAG.","[{'ForeName': 'Ming-Yu', 'Initials': 'MY', 'LastName': 'Lo', 'Affiliation': 'School of Graduate Institute of Chinese Medicine, College of Chinese Medicine, China Medicine University, China Medical University, Taichung, Taiwan.'}, {'ForeName': 'Chueh-Hung', 'Initials': 'CH', 'LastName': 'Wu', 'Affiliation': 'Department of Physical Medicine & Rehabilitation, National Taiwan University Hospital, College of Medicine, National Taiwan University, Taipei, Taiwan.'}, {'ForeName': 'Jer-Junn', 'Initials': 'JJ', 'LastName': 'Luh', 'Affiliation': 'School of Physical Therapy, College of Medicine, National Taiwan University, Taipei, Taiwan.'}, {'ForeName': 'Tyng-Guey', 'Initials': 'TG', 'LastName': 'Wang', 'Affiliation': 'Department of Physical Medicine & Rehabilitation, National Taiwan University Hospital, College of Medicine, National Taiwan University, Taipei, Taiwan; Health Science & Wellness Center, National Taiwan University, Taipei, Taiwan.'}, {'ForeName': 'Li-Chen', 'Initials': 'LC', 'LastName': 'Fu', 'Affiliation': 'Department of Computer Science & Information Engineering & Department of Electrical Engineering, College of Electrical Engineering & Computer Science, National Taiwan University, Taipei, Taiwan; Health Science & Wellness Center, National Taiwan University, Taipei, Taiwan.'}, {'ForeName': 'Jaung-Geng', 'Initials': 'JG', 'LastName': 'Lin', 'Affiliation': 'School of Graduate Institute of Chinese Medicine, College of Chinese Medicine, China Medicine University, China Medical University, Taichung, Taiwan. Electronic address: loming.yu@msa.hinet.net.'}, {'ForeName': 'Jin-Shin', 'Initials': 'JS', 'LastName': 'Lai', 'Affiliation': 'Department of Physical Medicine & Rehabilitation, National Taiwan University Hospital, College of Medicine, National Taiwan University, Taipei, Taiwan; Health Science & Wellness Center, National Taiwan University, Taipei, Taiwan. Electronic address: jslai@ntu.edu.tw.'}]",Journal of the Formosan Medical Association = Taiwan yi zhi,['10.1016/j.jfma.2019.03.012'] 1017,31743412,Evaluation of an Entrepreneurship Education Intervention for American Indian Adolescents: Trial Design and Baseline Sample Characteristics.,"Entrepreneurship education is a strength-based approach and holds promise for promoting health equity for American Indian youth. Arrowhead Business Group (ABG) was developed by a tribal-academic research partnership and is being rigorously evaluated for impacts on psychosocial, behavioral, educational, and economic outcomes. This article describes: 1) the trial design and conceptual model under-girding the ABG program; 2) the sociodemographic, sociocultural, and family/household characteristics of participants at baseline; and 3) the baseline differences in key outcome indicators between study groups. Results demonstrate participants have baseline characteristics appropriate for study aims and are compared and contrasted with other youth from the participating tribal community and state in which the tribe resides. Findings inform future analyses to explore how baseline characteristics are associated with primary and secondary outcomes of the evaluation.",2019,"Arrowhead Business Group (ABG) was developed by a tribal-academic research partnership and is being rigorously evaluated for impacts on psychosocial, behavioral, educational, and economic outcomes.","['American Indian youth', 'American Indian Adolescents']",['Entrepreneurship Education Intervention'],[],"[{'cui': 'C0002460', 'cui_str': 'American Indians'}, {'cui': 'C0087178', 'cui_str': 'Youth'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}]","[{'cui': 'C0085116', 'cui_str': 'Entrepreneurship'}, {'cui': 'C0013621', 'cui_str': 'Education'}]",[],,0.0875093,"Arrowhead Business Group (ABG) was developed by a tribal-academic research partnership and is being rigorously evaluated for impacts on psychosocial, behavioral, educational, and economic outcomes.","[{'ForeName': 'Francene', 'Initials': 'F', 'LastName': 'Larzelere', 'Affiliation': ''}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Tingey', 'Affiliation': ''}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Ingalls', 'Affiliation': ''}, {'ForeName': 'Feather', 'Initials': 'F', 'LastName': 'Sprengeler', 'Affiliation': ''}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'Parker', 'Affiliation': ''}, {'ForeName': 'Summer', 'Initials': 'S', 'LastName': 'Rosenstock', 'Affiliation': ''}, {'ForeName': 'Larissa', 'Initials': 'L', 'LastName': 'Jennings', 'Affiliation': ''}, {'ForeName': 'Mariddie', 'Initials': 'M', 'LastName': 'Craig', 'Affiliation': ''}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': ""O'Keefe"", 'Affiliation': ''}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Barlow', 'Affiliation': ''}]",American Indian and Alaska native mental health research (Online),['10.5820/aian.2603.2019.1'] 1018,31762463,Transcranial Direct Current Stimulation for Online Gamers.,"Transcranial direct current stimulation (tDCS) is a noninvasive brain stimulation technique that applies a weak electric current to the scalp to modulate neuronal membrane potentials. Compared to other brain stimulation methods, tDCS is relatively safe, simple, and inexpensive to administer. Since excessive online gaming can negatively affect mental health and daily functioning, developing treatment options for gamers is necessary. Although tDCS over the dorsolateral prefrontal cortex (DLPFC) has demonstrated promising results for various addictions, it has not been tested in gamers. This paper describes a protocol and a feasibility study for applying repeated tDCS over the DLPFC and neuroimaging to examine the underlying neural correlates in gamers. At baseline, individuals who play online games report average weekly hours spent on games, complete questionnaires on addiction symptoms and self-control, and undergo brain 18 F-fluoro-2-deoxyglucose positron emission tomography (FDG-PET). The tDCS protocol consists of 12 sessions over the DLPFC for 4 weeks (anode F3/cathode F4, 2 mA for 30 min per session). Then, a follow-up is conducted using the same protocol as the baseline. Individuals who do not play online games receive only baseline FDG-PET scans without tDCS. Changes of clinical characteristics and asymmetry of regional cerebral metabolic rate of glucose (rCMRglu) in the DLPFC are examined in gamers. In addition, asymmetry of rCMRglu is compared between gamers and non-gamers at baseline. In our experiment, 15 gamers received tDCS sessions and completed baseline and follow-up scans. Ten non-gamers underwent FDG-PET scans at the baseline. The tDCS reduced addiction symptoms, time spent on games, and increased self-control. Moreover, abnormal asymmetry of rCMRglu in the DLPFC at baseline was alleviated after tDCS. The current protocol may be useful for assessing treatment efficacy of tDCS and its underlying brain changes in gamers. Further randomized sham-controlled studies are warranted. Moreover, the protocol can be applied to other neurological and psychiatric disorders.",2019,"The tDCS reduced addiction symptoms, time spent on games, and increased self-control.","['Online Gamers', 'gamers', 'Individuals who do not play online games receive only baseline FDG-PET scans without tDCS']","['Transcranial Direct Current Stimulation', 'tDCS', 'Transcranial direct current stimulation (tDCS']","['regional cerebral metabolic rate of glucose (rCMRglu', 'addiction symptoms, time spent on games, and increased self-control']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0577490', 'cui_str': 'Does not play (finding)'}, {'cui': 'C0032743', 'cui_str': 'Positron-Emission Tomography'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}]","[{'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0085281', 'cui_str': 'Addictive Behavior'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0684274', 'cui_str': 'Self Regulation'}]",,0.0438511,"The tDCS reduced addiction symptoms, time spent on games, and increased self-control.","[{'ForeName': 'Sang Hoon', 'Initials': 'SH', 'LastName': 'Lee', 'Affiliation': ""Department of Radiology, Yeouido St. Mary's Hospital, College of Medicine, The Catholic University of Korea.""}, {'ForeName': 'Jooyeon Jamie', 'Initials': 'JJ', 'LastName': 'Im', 'Affiliation': ""Department of Radiology, Incheon St. Mary's Hospital, College of Medicine, The Catholic University of Korea.""}, {'ForeName': 'Jin Kyoung', 'Initials': 'JK', 'LastName': 'Oh', 'Affiliation': ""Department of Radiology, Incheon St. Mary's Hospital, College of Medicine, The Catholic University of Korea.""}, {'ForeName': 'Eun Kyoung', 'Initials': 'EK', 'LastName': 'Choi', 'Affiliation': ""Department of Radiology, Incheon St. Mary's Hospital, College of Medicine, The Catholic University of Korea.""}, {'ForeName': 'Sujung', 'Initials': 'S', 'LastName': 'Yoon', 'Affiliation': 'Department of Brain and Cognitive Sciences, Ewha Womans University.'}, {'ForeName': 'Marom', 'Initials': 'M', 'LastName': 'Bikson', 'Affiliation': 'Department of Biomedical Engineering, The City College of New York.'}, {'ForeName': 'In-Uk', 'Initials': 'IU', 'LastName': 'Song', 'Affiliation': ""Department of Neurology, Incheon St. Mary's Hospital, College of Medicine, The Catholic University of Korea.""}, {'ForeName': 'Hyeonseok', 'Initials': 'H', 'LastName': 'Jeong', 'Affiliation': ""Department of Radiology, Incheon St. Mary's Hospital, College of Medicine, The Catholic University of Korea; hsjeong@catholic.ac.kr.""}, {'ForeName': 'Yong-An', 'Initials': 'YA', 'LastName': 'Chung', 'Affiliation': ""Department of Radiology, Incheon St. Mary's Hospital, College of Medicine, The Catholic University of Korea; yongan@catholic.ac.kr.""}]",Journal of visualized experiments : JoVE,['10.3791/60007'] 1019,31742249,Immediate effect of photobiomodulation therapy on Achilles tendon morphology and mechanical properties: an exploratory study.,"Objectives Evaluate the immediate (within 4 hours) effects of laser-induced photobiomodulation (PBM) therapy on Achilles tendon morphology and mechanical properties in healthy and pathologic tendons. Materials and Methods Twenty people with healthy Achilles tendons and twelve people with Achilles tendinopathy participated. One Achilles tendon received PBM treatment following an established protocol and the contralateral side received a placebo treatment. Achilles tendon morphology and mechanical properties were evaluated bilaterally with ultrasound imaging and continuous shear wave elastography immediately before treatment, immediately after treatment, then 2- and 4-hours after treatment. Results There were no immediate effects of PBM on tendon morphology or mechanical properties when comparing the PBM-treated side and placebo-treated side within each cohort. Additionally, the effects of PBM did not differ between healthy and pathologic Achilles tendons. Conclusion When treated with a laser-induced PBM treatment, healthy and pathologic Achilles tendons do not have immediate (within 4 hours) changes in tendon morphology or mechanical properties. These findings suggest that PBM therapy can be administered before other clinical treatments or high-load activities.",2019,There were no immediate effects of PBM on tendon morphology or mechanical properties when comparing the PBM-treated side and placebo-treated side within each cohort.,"['Twenty people with healthy Achilles tendons and twelve people with Achilles tendinopathy participated', 'healthy and pathologic tendons']","['placebo treatment', 'PBM', 'photobiomodulation therapy', 'PBM therapy', 'laser-induced photobiomodulation (PBM) therapy', 'laser-induced PBM']","['tendon morphology or mechanical properties', 'Achilles tendon morphology and mechanical properties']","[{'cui': 'C0001074', 'cui_str': 'Calcaneal Tendon'}, {'cui': 'C3840085', 'cui_str': 'Disorder of Achilles tendon (disorder)'}, {'cui': 'C1521733', 'cui_str': 'Pathologic (qualifier value)'}, {'cui': 'C0039508', 'cui_str': 'Tendons'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0071006', 'cui_str': 'phytobacteriomycin'}, {'cui': 'C4019433', 'cui_str': 'LLLT'}, {'cui': 'C0023089', 'cui_str': 'Lasers'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}]","[{'cui': 'C0039508', 'cui_str': 'Tendons'}, {'cui': 'C0543482', 'cui_str': 'morphology'}, {'cui': 'C0443254', 'cui_str': 'Mechanical (qualifier value)'}, {'cui': 'C0871161', 'cui_str': 'Property (attribute)'}]",20.0,0.068578,There were no immediate effects of PBM on tendon morphology or mechanical properties when comparing the PBM-treated side and placebo-treated side within each cohort.,"[{'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Corrigan', 'Affiliation': 'Department of Physical Therapy, University of Delaware, Newark, DE, USA.'}, {'ForeName': 'Daniel H', 'Initials': 'DH', 'LastName': 'Cortes', 'Affiliation': 'Department of Mechanical and Nuclear Engineering, Penn State University, State College, PA, USA.'}, {'ForeName': 'Karin Grävare', 'Initials': 'KG', 'LastName': 'Silbernagel', 'Affiliation': 'Department of Physical Therapy, University of Delaware, Newark, DE, USA.'}]",Translational sports medicine,['10.1002/tsm2.78'] 1020,31751163,Health-Related Quality of Life With Carboplatin-Paclitaxel or nab-Paclitaxel With or Without Pembrolizumab in Patients With Metastatic Squamous Non-Small-Cell Lung Cancer.,"PURPOSE In the phase 3 KEYNOTE-407 study, the addition of pembrolizumab to carboplatin-paclitaxel/nab-paclitaxel significantly improved overall survival, progression-free survival, and objective response rate in patients with previously untreated metastatic squamous non-small-cell lung cancer (NSCLC), with little impact on severe toxicity. We present patient-reported outcomes (PROs) from KEYNOTE-407. METHODS Patients were randomly assigned to receive 4 cycles of pembrolizumab 200 mg or placebo once every 3 weeks plus carboplatin plus paclitaxel or nab-paclitaxel, followed by pembrolizumab or placebo for an additional 31 cycles. Health-related quality of life (HRQoL) was evaluated using the European Organisation for Research and Treatment of Cancer Treatment of Cancer Quality of Life Questionnaire-Core 30 (QLQ-C30) and Quality of Life Questionnaire-Lung Cancer Module 13 (QLQ-LC13). Key PRO endpoints were change from baseline to weeks 9 and 18 (during and after platinum therapy) in the QLQ-C30 global health status/quality of life (GHS/QoL) score and time to deterioration in the composite endpoint of cough, chest pain, or dyspnea from the QLQ-C30 and QLQ-LC13. Two-sided, nominal P values are provided. RESULTS A total of 554 and 553 patients completed ≥ 1 QLQ-C30 or ≥ 1 QLQ-LC13 assessment, respectively. GHS/QoL score improved for the pembrolizumab-combination group (least squares [LS] mean [95% CI] change from baseline: week 9, 1.8 [-0.9 to 4.4]; week 18, 4.3 [1.7 to 6.9]) and deteriorated in the placebo-combination group (week 9, -1.8 [-4.4 to 0.7]; week 18, -0.57 [-3.3 to 2.2]). Between-group differences were improved for the pembrolizumab-combination group (difference in LS mean scores: week 9, 3.6 [95% CI, 0.3 to 6.9], nominal P = .0337; week 18, 4.9 [1.4 to 8.3], nominal P = .0060). Median time to deterioration in cough, chest pain, or dyspnea was not reached in either group (hazard ratio, 0.79; 95% CI, 0.58 to 1.06]; nominal P = .125). CONCLUSION Addition of pembrolizumab to chemotherapy maintained or improved HRQoL measurements relative to baseline and improved HRQoL versus chemotherapy alone at weeks 9 and 18. These results support use of pembrolizumab plus chemotherapy as first-line therapy for metastatic squamous NSCLC.",2020,Addition of pembrolizumab to chemotherapy maintained or improved HRQoL measurements relative to baseline and improved HRQoL versus chemotherapy alone at weeks 9 and 18.,"['Patients', 'metastatic squamous NSCLC', 'Patients With Metastatic Squamous Non-Small-Cell Lung Cancer', 'A total of 554 and 553 patients completed ≥ 1 QLQ-C30 or ≥ 1 QLQ-LC13 assessment, respectively', 'patients with previously untreated metastatic squamous non-small-cell lung cancer (NSCLC']","['pembrolizumab to carboplatin-paclitaxel/nab-paclitaxel', 'pembrolizumab 200 mg or placebo', 'pembrolizumab', 'carboplatin plus paclitaxel or nab-paclitaxel, followed by pembrolizumab or placebo', 'pembrolizumab plus chemotherapy', 'Carboplatin-Paclitaxel or nab-Paclitaxel With or Without Pembrolizumab']","['overall survival, progression-free survival, and objective response rate', 'Median time to deterioration in cough, chest pain, or dyspnea', 'HRQoL measurements', 'GHS/QoL score', 'Cancer Quality of Life Questionnaire-Core 30 (QLQ-C30) and Quality of Life Questionnaire-Lung Cancer Module 13 (QLQ-LC13', 'QLQ-C30 global health status/quality of life (GHS/QoL) score and time to deterioration in the composite endpoint of cough, chest pain, or dyspnea from the QLQ-C30 and QLQ-LC13', 'Health-related quality of life (HRQoL']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C4509816', 'cui_str': 'Squamous non-small cell lung cancer'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]","[{'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C1527223', 'cui_str': '130-nm albumin-bound paclitaxel'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0010200', 'cui_str': 'Complaining of cough (finding)'}, {'cui': 'C0008031', 'cui_str': 'Chest Pain'}, {'cui': 'C0013404', 'cui_str': 'Breathlessness'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0034380'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0444669', 'cui_str': 'Core (qualifier value)'}, {'cui': 'C1306460', 'cui_str': 'Primary malignant neoplasm of lung'}, {'cui': 'C3542953', 'cui_str': 'Module (core metadata concept)'}, {'cui': 'C1456573', 'cui_str': 'Global Health'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}]",553.0,0.355644,Addition of pembrolizumab to chemotherapy maintained or improved HRQoL measurements relative to baseline and improved HRQoL versus chemotherapy alone at weeks 9 and 18.,"[{'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Mazieres', 'Affiliation': 'Centre Hospitalier Universitaire de Toulouse, Université Paul Sabatier, Toulouse, France.'}, {'ForeName': 'Dariusz', 'Initials': 'D', 'LastName': 'Kowalski', 'Affiliation': 'Maria Skłodowska-Curie Institute of Oncology, Warsaw, Poland.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Luft', 'Affiliation': 'Leningrad Regional Clinical Hospital, St Petersburg, Russia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Vicente', 'Affiliation': 'Hospital Universitario Virgen Macarena, Seville, Spain.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Tafreshi', 'Affiliation': 'Wollongong Oncology and University of Wollongong, Wollongong, NSW, Australia.'}, {'ForeName': 'Mahmut', 'Initials': 'M', 'LastName': 'Gümüş', 'Affiliation': 'Istanbul Medeniyet University Hospital, Istanbul, Turkey.'}, {'ForeName': 'Konstantin', 'Initials': 'K', 'LastName': 'Laktionov', 'Affiliation': 'N.N. Blokhin Russian Cancer Research Center, Moscow, Russia.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Hermes', 'Affiliation': 'Universitätsklinikum Tübingen, Tübingen, Germany.'}, {'ForeName': 'Irfan', 'Initials': 'I', 'LastName': 'Cicin', 'Affiliation': 'Trakya University, Edirne, Turkey.'}, {'ForeName': 'Jerónimo', 'Initials': 'J', 'LastName': 'Rodríguez-Cid', 'Affiliation': 'Oncology Center, Medica Sur Hospital, Mexico City, Mexico.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Wilson', 'Affiliation': 'Humber River Regional Hospital, Toronto, ON, Canada.'}, {'ForeName': 'Terufumi', 'Initials': 'T', 'LastName': 'Kato', 'Affiliation': 'Kanagawa Cancer Center, Yokohama, Japan.'}, {'ForeName': 'Rodryg', 'Initials': 'R', 'LastName': 'Ramlau', 'Affiliation': 'Poznan University of Medical Sciences, Poznan, Poland.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Novello', 'Affiliation': 'University of Turin, AOU San Luigi, Orbassano, Italy.'}, {'ForeName': 'Sreekanth', 'Initials': 'S', 'LastName': 'Reddy', 'Affiliation': 'Northside Hospital Cancer Institute, Atlanta, GA.'}, {'ForeName': 'Hans-Georg', 'Initials': 'HG', 'LastName': 'Kopp', 'Affiliation': 'Robert-Bosch Cancer Center, Klinik Schillerhöhe, Gerlingen, Germany.'}, {'ForeName': 'Bilal', 'Initials': 'B', 'LastName': 'Piperdi', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ.'}, {'ForeName': 'Xiaodong', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Burke', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Paz-Ares', 'Affiliation': 'Hospital Universitario 12 de Octubre, CNIO-H12o Lung Cancer Unit, Universidad Complutense and Ciberonc, Madrid, Spain.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.01348'] 1021,31747355,Vitamin C Bioequivalence from Gummy and Caplet Sources in Healthy Adults: A Randomized-Controlled Trial.,"Background: The efficacy of Vitamin C (L-ascorbic acid) supplementation can be assessed by uptake into the blood and retention in leukocytes. Vitafusion® Power C gummy is an alternative vitamin C source which may exhibit similar bioavailability to comparator caplets. Objective: The objective of this study was to evaluate the bioequivalence of vitamin C from a vitafusion® Power C gummy formulation and a comparator caplet in healthy adults. Methods: Thirty healthy men and women, 34.0 ± 11.4 years of age and Body Mass Index (BMI) 24.5 ± 3.6 kg/m 2 completed the randomized examiner-blind, comparator controlled, cross-over trial with two sequences: gummy (1000 mg) to caplet (1000 mg) or caplet to gummy. Intake of foods fortified with Vitamin C was restricted 7 days prior to each dosing. Blood samples were collected pre-dose and at 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12 and 24 h post-dose for plasma and leukocytes; and urine was collected pre-dose and between 0-2, 2-4, 4-8, 8-12 and 12-24 h post-dose for L-ascorbic acid analysis. Results: Vitafusion® Power C gummy and comparator caplet demonstrated similar plasma absorption profiles as there were no significant differences in plasma L-ascorbic acid total Area Under the Curve (AUC) 0-24h , and T max between gummy and caplet. The caplet did elicit a significantly higher C max than the gummy ( p  < 0.05), however, the difference was numerically small. Leukocyte L-ascorbic acid total AUC 0-24h and C max were not significantly different between gummy and caplet, however T max of the gummy group was significantly longer ( p  = 0.012). Urinary L-ascorbic acid levels were also not significantly different between gummy and caplet. There were no serious adverse events and safety parameters remained within normal clinical range for both products. Conclusion: Vitafusion® Power C gummy exhibited similar Vitamin C absorption and bioavailability to a comparator caplet in healthy adults and were considered bioequivalent.",2020,"Leukocyte L-ascorbic acid total AUC 0-24h and C max were not significantly different between gummy and caplet, however T max of the gummy group was significantly longer ( p  = 0.012).","['Healthy Adults', 'Thirty healthy men and women, 34.0\u2009±\u200911.4 years of age and Body Mass Index (BMI) 24.5\u2009±\u20093.6\u2009kg/m 2', 'healthy adults']","['Vitamin C Bioequivalence', 'foods fortified with Vitamin C', 'Vitafusion®', 'vitamin C', 'caplet (1000\u2009mg) or caplet to gummy', 'Vitamin C (L-ascorbic acid) supplementation']","['Leukocyte L-ascorbic acid total AUC 0-24h and C max', 'serious adverse events and safety parameters', 'Urinary L-ascorbic acid levels', 'Vitamin C absorption and bioavailability', 'plasma L-ascorbic acid total Area Under the Curve (AUC) 0-24h , and T max']","[{'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C4517533', 'cui_str': '11.4'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517694', 'cui_str': '3.6 (qualifier value)'}]","[{'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C0039789', 'cui_str': 'Generic Equivalency'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C1883310', 'cui_str': '1000 (qualifier value)'}]","[{'cui': 'C0023516', 'cui_str': 'Blood Corpuscles, White'}, {'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C2347023', 'cui_str': 'Absorption'}, {'cui': 'C0005508', 'cui_str': 'Bioavailability'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}]",30.0,0.100215,"Leukocyte L-ascorbic acid total AUC 0-24h and C max were not significantly different between gummy and caplet, however T max of the gummy group was significantly longer ( p  = 0.012).","[{'ForeName': 'Malkanthi', 'Initials': 'M', 'LastName': 'Evans', 'Affiliation': 'KGK Science Inc, London, Ontario, Canada.'}, {'ForeName': 'Najla', 'Initials': 'N', 'LastName': 'Guthrie', 'Affiliation': 'KGK Science Inc, London, Ontario, Canada.'}, {'ForeName': 'H Kelly', 'Initials': 'HK', 'LastName': 'Zhang', 'Affiliation': 'Church & Dwight Co., Inc, Ewing, New Jersey, USA.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Hooper', 'Affiliation': 'Church & Dwight Co., Inc, Ewing, New Jersey, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Wong', 'Affiliation': 'Church & Dwight Co., Inc, Ewing, New Jersey, USA.'}, {'ForeName': 'Annahita', 'Initials': 'A', 'LastName': 'Ghassemi', 'Affiliation': 'Church & Dwight Co., Inc, Ewing, New Jersey, USA.'}]",Journal of the American College of Nutrition,['10.1080/07315724.2019.1684398'] 1022,31142873,"The efficacy of a non-leaching antibacterial central venous catheter - a prospective, randomized, double-blind study.","BACKGROUND Antimicrobial coatings of central venous catheters (CVC) have the potential to reduce the risk of infectious complications. The aim of this study was to examine the efficacy of a catheter with a non-leaching antimicrobial coating against catheter colonization and bloodstream infections (BSI). METHODS The study was conducted in two centers using a prospective, randomized, double-blind and controlled design (680 intensive care patients; a protective CVC (Certofix® protect) or a standard CVC (Certofix®). Primary objectives were the rates of catheter colonization and BSI in the two groups. Other baseline demographics, APACHE II score, insertion site, location of CVC placement (ICU or theatre), indwelling time and length of ICU stay were comparable for both groups. RESULTS While the rate of catheter colonization between the coated and uncoated CVC (17.4% vs. 18.7%, P=0.7477) and the rate of microbiologically confirmed catheter associated infections were similar (1.4% vs. 1.9%, P=0.7521), the coated CVC showed a significantly lower incidence of BSI (2.0% vs. 6.5%, P=0.0081) and a significantly lower mean incidence of BSI per 1000 catheter days (3.2 vs. 8.3, P=0.0356). CONCLUSION The non-leaching antibacterial coating of the protective catheter was effective in reducing the incidence of BSI but not the rate of catheter colonization. However, the incidence of BSI is a better surrogate marker for the risk of developing clinical signs of infection suggesting that use of the non-leaching protective catheter is effective in this regard. Trial number: ClinicalTrials.gov (ID: NCT00555282), https://clinicaltrials.gov/show/NCT00555282.",2020,The non-leaching antibacterial coating of the protective catheter was effective in reducing the incidence of BSI but not the rate of catheter colonization.,['680 intensive care patients; a'],"['catheter with a non-leaching antimicrobial coating', 'central venous catheters (CVC', 'protective CVC (Certofix® protect) or a standard CVC (Certofix®', 'non-leaching antibacterial central venous catheter ']","['rate of catheter colonization', 'APACHE II score, insertion site, location of CVC placement (ICU or theatre), indwelling time and length of ICU stay', 'BSI', 'rate of microbiologically confirmed catheter associated infections', 'rates of catheter colonization and BSI']","[{'cui': 'C0085559'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0085590', 'cui_str': 'Catheters'}, {'cui': 'C1136254', 'cui_str': 'Microbicides'}, {'cui': 'C1145640', 'cui_str': 'Central Venous Catheters'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0279516', 'cui_str': 'Anti-Bacterial Agents'}]","[{'cui': 'C0085590', 'cui_str': 'Catheters'}, {'cui': 'C0489438', 'cui_str': 'APACHE II score'}, {'cui': 'C0449682', 'cui_str': 'Site of insertion (attribute)'}, {'cui': 'C0450429', 'cui_str': 'Location (attribute)'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0475307', 'cui_str': 'Theatre (environment)'}, {'cui': 'C0439848', 'cui_str': 'Indwelling (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0860239', 'cui_str': 'Catheter-Associated Infections'}]",,0.167349,The non-leaching antibacterial coating of the protective catheter was effective in reducing the incidence of BSI but not the rate of catheter colonization.,"[{'ForeName': 'Ivo', 'Initials': 'I', 'LastName': 'Krikava', 'Affiliation': 'Department of Pain Treatment, Department of Paediatric Anaesthesiology and Resuscitation, University Hospital Brno and Department of Paediatric Anaesthesiology and Resuscitation, Faculty of Medicine, Masaryk University, Brno, Czech Republic.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Kolar', 'Affiliation': 'Department of Anesthesiology and Critical Care, University Hospital Kralovske Vinohrady, Prague, and Department of Anaesthesiology and Resuscitation, 3rd Faculty of Medicine, Charles University, Prague, Czech Republic.'}, {'ForeName': 'Barbora', 'Initials': 'B', 'LastName': 'Garajova', 'Affiliation': 'Department of Surgery, University Hospital Brno, Brno, Czech Republic.'}, {'ForeName': 'Tomas', 'Initials': 'T', 'LastName': 'Balik', 'Affiliation': 'Department of Anesthesiology and Critical Care, University Hospital Kralovske Vinohrady, Prague, Czech Republic.'}, {'ForeName': 'Alena', 'Initials': 'A', 'LastName': 'Sevcikova', 'Affiliation': 'Department of Clinical Microbiology, University Hospital Brno, Brno and Department of Laboratory Methods, Faculty of Medicine, Masaryk University, Brno, Czech Republic.'}, {'ForeName': 'Ingolf', 'Initials': 'I', 'LastName': 'Roschke', 'Affiliation': 'Dr. Roschke GMBH, Cologne, Germany.'}, {'ForeName': 'Pavel', 'Initials': 'P', 'LastName': 'Sevcik', 'Affiliation': 'Depatment of Anaesthesiology and Resuscitation, University Hospital Ostrava and Department of Intensive Medicine and Forensic Studies, Faculty of Medicine, University of Ostrava, Ostrava, Czech Republic.'}]","Biomedical papers of the Medical Faculty of the University Palacky, Olomouc, Czechoslovakia",['10.5507/bp.2019.022'] 1023,31667693,Sterile carbon particle suspension vs India ink for endoscopic tattooing of colonic lesions: a randomized controlled trial.,"BACKGROUND Different markers have been used preoperatively to mark colonic lesions, especially India ink. In recent years, another kind of marker has been developed: sterile carbon particle suspension (SCPS). No comparison between these two markers has yet been made. The aim of the present study was to compare the pyrogenic, inflammatory and intraperitoneal effect of these two markers. METHODS From September 2015 to December 2018, adult patients who were candidates for elective laparoscopic colon resection were randomized to the SCPS or conventional India ink injection group using computer-based randomization. The primary endpoint of the study was the presence of intraoperative adhesions related to the endoscopic tattoo. Secondary endpoints were differences in white blood cell, C-reactive protein, and fibrinogen levels as well as, abdominal pain and body temperature at baseline (before endoscopic tattooing) and 6 and 24 h after colonoscopy. Finally, the visibility of the tattoo during the minimally invasive intervention was assessed. RESULTS Ninety-four patients were included in the study, 47 for each arm. There were 45/94 females (47.9%) and 49/94 males (52.1%), with a median age of 67.85 ± 9.22 years. No differences were found between groups in WBC, fibrinogen levels, body temperature or VAS scores, but we documented significantly higher CRP values at 6 and 24 h after endoscopic tattooing with India ink injection. There were significantly fewer adhesions in the SCPS Endoscopic Marker group. All the endoscopic tattoos were clearly visible. CONCLUSIONS SCPS is an effective method for tattooing colonic lesions and has a better safety profile than traditional India ink in terms of post-procedure inflammatory response and intraoperative bowel adhesions. CLINICAL TRIAL REGISTRATION clinicaltrials.gov (ID: NCT03637933).",2019,"CONCLUSIONS SCPS is an effective method for tattooing colonic lesions and has a better safety profile than traditional India ink in terms of post-procedure inflammatory response and intraoperative bowel adhesions. ","['adult patients who were candidates for elective laparoscopic colon resection', 'colonic lesions', 'Ninety-four patients were included in the study, 47 for each arm', 'From September 2015 to December 2018', 'There were 45/94 females (47.9%) and 49/94 males (52.1%), with a median age of 67.85\u2009±\u20099.22\xa0years']","['SCPS', 'Sterile carbon particle suspension vs India ink', 'SCPS or conventional India ink injection group using computer-based randomization']","['intraoperative adhesions related to the endoscopic tattoo', 'CRP values', 'WBC, fibrinogen levels, body temperature or VAS scores', 'white blood cell, C-reactive protein, and fibrinogen levels as well as, abdominal pain and body temperature', 'adhesions']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0009368', 'cui_str': 'Colon'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C3874484', 'cui_str': 'Colonic lesion'}, {'cui': 'C3816959', 'cui_str': 'Ninety'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0232920', 'cui_str': 'Sterile (qualifier value)'}, {'cui': 'C0007009', 'cui_str': 'Carbon-12'}, {'cui': 'C1382107', 'cui_str': 'Suspension'}, {'cui': 'C0123471', 'cui_str': 'India ink'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009622', 'cui_str': 'Computers'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}]","[{'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0001511', 'cui_str': 'Tissue Adhesions'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C1366940', 'cui_str': 'Tattoo of skin (finding)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0023516', 'cui_str': 'Blood Corpuscles, White'}, {'cui': 'C0337428', 'cui_str': 'Fibrinogen measurement'}, {'cui': 'C0886414', 'cui_str': 'Body temperature'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0000737', 'cui_str': 'Abdominal Pain'}]",94.0,0.121836,"CONCLUSIONS SCPS is an effective method for tattooing colonic lesions and has a better safety profile than traditional India ink in terms of post-procedure inflammatory response and intraoperative bowel adhesions. ","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Milone', 'Affiliation': 'Department of Clinical Medicine and Surgery, Federico II University of Naples, Via Sergio Pansini, 5, 80131, Naples, Italy.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Vignali', 'Affiliation': 'Department of Gastrointestinal Surgery, San Raffaele Hospital and San Raffaele Vita-Salute University, Via Olgettina 60, 20132, Milan, Italy.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Manigrasso', 'Affiliation': 'Department of Clinical Medicine and Surgery, Federico II University of Naples, Via Sergio Pansini, 5, 80131, Naples, Italy.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Velotti', 'Affiliation': 'Department of Clinical Medicine and Surgery, Federico II University of Naples, Via Sergio Pansini, 5, 80131, Naples, Italy.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Sarnelli', 'Affiliation': 'Department of Clinical Medicine and Surgery, Federico II University of Naples, Via Sergio Pansini, 5, 80131, Naples, Italy.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Aprea', 'Affiliation': 'Department of Clinical Medicine and Surgery, Federico II University of Naples, Via Sergio Pansini, 5, 80131, Naples, Italy.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'De Simone', 'Affiliation': 'Department of Clinical Medicine and Surgery, Federico II University of Naples, Via Sergio Pansini, 5, 80131, Naples, Italy.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Maione', 'Affiliation': 'Department of Clinical Medicine and Surgery, Federico II University of Naples, Via Sergio Pansini, 5, 80131, Naples, Italy.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Gennarelli', 'Affiliation': 'Department of Clinical Medicine and Surgery, Federico II University of Naples, Via Sergio Pansini, 5, 80131, Naples, Italy.'}, {'ForeName': 'U', 'Initials': 'U', 'LastName': 'Elmore', 'Affiliation': 'Department of Gastrointestinal Surgery, San Raffaele Hospital and San Raffaele Vita-Salute University, Via Olgettina 60, 20132, Milan, Italy. elmore.ugo@hsr.it.'}, {'ForeName': 'G D', 'Initials': 'GD', 'LastName': 'De Palma', 'Affiliation': 'Department of Clinical Medicine and Surgery, Federico II University of Naples, Via Sergio Pansini, 5, 80131, Naples, Italy.'}]",Techniques in coloproctology,['10.1007/s10151-019-02101-y'] 1024,31740114,Early outcomes with durable left ventricular assist device replacement using the HeartMate 3.,"BACKGROUND The HeartMate 3 (HM3) left ventricular assist device (LVAD) (Abbott, Inc, Chicago, Ill) is a fully magnetically levitated centrifugal implantable pump used to treat patients with chronic heart failure. The MOMENTUM (Multicenter Study of MagLev Technology in Patients Undergoing Mechanical Circulatory Support Therapy With HeartMate 3) trial demonstrated that patients treated with the HM3 experienced reduced need for reoperation for LVAD replacement compared with a control group receiving an axial flow design, Heartmate II (Abbott, Inc). However, there are few reports of using HM3 as the replacement pump in patients who already are supported by a durable LVAD and experience a device-related complication necessitating replacement. METHODS An institutional LVAD database was used to identify 19 consecutive patients who underwent pump replacement to HM3 (group 1) versus 85 consecutive control patients who underwent pump replacement to either Heartmate II or HeartWare Ventricular Assist Device (Medtronic Inc, Minneapolis, Minn) (group 2), at a single institution from January 2010 to August 2018. Patient baseline characteristic and outcomes were obtained from a prospectively maintained database. The primary endpoint was a composite of freedom from death or need for another replacement surgery. RESULTS There was no difference between the groups in heart failure etiology, indication for replacement, as well as the average days on the previous pump or the type of previous pump. The HM3 group did have a significantly greater body mass index (37 vs 31.6 P = .01), a greater number of previous LVAD implants (36.8% vs 5.9%, had 2 previous LVADs, P < .001), and a greater number of previous sternotomies (31.6% vs 7.1%, had 3 previous sternotomies, P = .001). No difference was found between the groups in terms of postoperative adverse event rates. With regards to the primary endpoint, the patients with HM3 replacements (group 1) versus group 2 experienced significantly greater freedom from either death or need for another replacement during the follow-up period (P = .039). During follow-up, there were no thrombosis events for the patients who received replacement with HM3. CONCLUSIONS LVAD replacement with HM3 can be performed safely and may be considered as the pump of choice in patients requiring LVAD replacement.",2020,"The HM3 group did have a significantly greater body mass index (37 vs 31.6 P = .01), a greater number of previous LVAD implants (36.8% vs 5.9%, had 2 previous LVADs, P ","['19 consecutive patients who underwent', 'patients with chronic heart failure', 'group 1) versus 85 consecutive control patients who underwent', 'patients requiring LVAD replacement', 'Patients Undergoing Mechanical Circulatory Support Therapy With HeartMate 3']","['pump replacement to HM3', 'Ventricular Assist Device', 'durable left ventricular assist device replacement', 'pump replacement to either Heartmate II or HeartWare', 'HeartMate 3 (HM3) left ventricular assist device (LVAD']","['number of previous sternotomies', 'composite of freedom from death or need for another replacement surgery', 'body mass index', 'greater number of previous LVAD implants', 'freedom from either death or need for another replacement', 'thrombosis events', 'postoperative adverse event rates', 'heart failure etiology']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0264716', 'cui_str': 'Chronic heart failure (disorder)'}, {'cui': 'C0441861', 'cui_str': 'Group 1 (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0443254', 'cui_str': 'Mechanical (qualifier value)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0085842', 'cui_str': 'Artificial Ventricle'}, {'cui': 'C0181598', 'cui_str': 'Left ventricular assist device'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0185792', 'cui_str': 'Sternotomy'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C2828363', 'cui_str': 'Implant'}, {'cui': 'C0040053', 'cui_str': 'Thrombosis'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0015127', 'cui_str': 'causes'}]",19.0,0.051187,"The HM3 group did have a significantly greater body mass index (37 vs 31.6 P = .01), a greater number of previous LVAD implants (36.8% vs 5.9%, had 2 previous LVADs, P ","[{'ForeName': 'Yaron D', 'Initials': 'YD', 'LastName': 'Barac', 'Affiliation': 'Division of Cardiothoracic Surgery, Duke University Medical Center, Durham, NC. Electronic address: yaronbar@icloud.com.'}, {'ForeName': 'Charles M', 'Initials': 'CM', 'LastName': 'Wojnarski', 'Affiliation': 'Division of Cardiothoracic Surgery, Duke University Medical Center, Durham, NC.'}, {'ForeName': 'Parichart', 'Initials': 'P', 'LastName': 'Junpaparp', 'Affiliation': 'Division of Cardiology, Duke University Medical Center, Durham, NC.'}, {'ForeName': 'Oliver K', 'Initials': 'OK', 'LastName': 'Jawitz', 'Affiliation': 'Division of Cardiothoracic Surgery, Duke University Medical Center, Durham, NC.'}, {'ForeName': 'Han', 'Initials': 'H', 'LastName': 'Billard', 'Affiliation': 'Division of Cardiothoracic Surgery, Duke University Medical Center, Durham, NC.'}, {'ForeName': 'Mani A', 'Initials': 'MA', 'LastName': 'Daneshmand', 'Affiliation': 'Division of Cardiothoracic Surgery, Duke University Medical Center, Durham, NC.'}, {'ForeName': 'Richa', 'Initials': 'R', 'LastName': 'Agrawal', 'Affiliation': 'Division of Cardiology, Duke University Medical Center, Durham, NC.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Devore', 'Affiliation': 'Division of Cardiology, Duke University Medical Center, Durham, NC.'}, {'ForeName': 'Chetan B', 'Initials': 'CB', 'LastName': 'Patel', 'Affiliation': 'Division of Cardiology, Duke University Medical Center, Durham, NC.'}, {'ForeName': 'Jacob N', 'Initials': 'JN', 'LastName': 'Schroder', 'Affiliation': 'Division of Cardiothoracic Surgery, Duke University Medical Center, Durham, NC.'}, {'ForeName': 'Carmelo A', 'Initials': 'CA', 'LastName': 'Milano', 'Affiliation': 'Division of Cardiothoracic Surgery, Duke University Medical Center, Durham, NC.'}]",The Journal of thoracic and cardiovascular surgery,['10.1016/j.jtcvs.2019.09.151'] 1025,29754952,"Early Time-Restricted Feeding Improves Insulin Sensitivity, Blood Pressure, and Oxidative Stress Even without Weight Loss in Men with Prediabetes.","Intermittent fasting (IF) improves cardiometabolic health; however, it is unknown whether these effects are due solely to weight loss. We conducted the first supervised controlled feeding trial to test whether IF has benefits independent of weight loss by feeding participants enough food to maintain their weight. Our proof-of-concept study also constitutes the first trial of early time-restricted feeding (eTRF), a form of IF that involves eating early in the day to be in alignment with circadian rhythms in metabolism. Men with prediabetes were randomized to eTRF (6-hr feeding period, with dinner before 3 p.m.) or a control schedule (12-hr feeding period) for 5 weeks and later crossed over to the other schedule. eTRF improved insulin sensitivity, β cell responsiveness, blood pressure, oxidative stress, and appetite. We demonstrate for the first time in humans that eTRF improves some aspects of cardiometabolic health and that IF's effects are not solely due to weight loss.",2018,"eTRF improved insulin sensitivity, β cell responsiveness, blood pressure, oxidative stress, and appetite.","['Men with prediabetes', 'Men with Prediabetes']","['eTRF', 'Intermittent fasting ']","['weight loss', 'cardiometabolic health', 'eTRF improved insulin sensitivity, β cell responsiveness, blood pressure, oxidative stress, and appetite', 'Insulin Sensitivity, Blood Pressure, and Oxidative Stress']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0362046', 'cui_str': 'Prediabetes'}]","[{'cui': 'C0205267', 'cui_str': 'Intermittent (qualifier value)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}]","[{'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0242606', 'cui_str': 'Oxidative Stress'}, {'cui': 'C0003618', 'cui_str': 'Appetite'}]",,0.0190782,"eTRF improved insulin sensitivity, β cell responsiveness, blood pressure, oxidative stress, and appetite.","[{'ForeName': 'Elizabeth F', 'Initials': 'EF', 'LastName': 'Sutton', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, LA 70808, USA.'}, {'ForeName': 'Robbie', 'Initials': 'R', 'LastName': 'Beyl', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, LA 70808, USA.'}, {'ForeName': 'Kate S', 'Initials': 'KS', 'LastName': 'Early', 'Affiliation': 'Health, Physical Education, and Exercise Science, Columbus State University, Columbus, GA 31907, USA.'}, {'ForeName': 'William T', 'Initials': 'WT', 'LastName': 'Cefalu', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, LA 70808, USA; American Diabetes Association, Arlington, VA 22202, USA.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Ravussin', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, LA 70808, USA.'}, {'ForeName': 'Courtney M', 'Initials': 'CM', 'LastName': 'Peterson', 'Affiliation': 'Pennington Biomedical Research Center, Baton Rouge, LA 70808, USA; Department of Nutrition Sciences, University of Alabama at Birmingham, Birmingham, AL 35294, USA. Electronic address: cpeterso@uab.edu.'}]",Cell metabolism,['10.1016/j.cmet.2018.04.010'] 1026,31171470,Daily Passive Muscle Stretching Improves Flow-Mediated Dilation of Popliteal Artery and 6-minute Walk Test in Elderly Patients with Stable Symptomatic Peripheral Artery Disease.,"BACKGROUND Patients with peripheral arterial disease (PAD) often have walking impairment due to insufficient oxygen supply to skeletal muscle. In aged rats, we have shown that daily stretching of calf muscles improves endothelium-dependent dilation of arterioles from the soleus muscle and increases capillarity and muscle blood flow during exercise. Therefore, we hypothesized that daily muscle stretching of calf muscles would improve endothelium-dependent vasodilation of the popliteal artery and walking function in PAD patients. METHODS We performed a randomized, non-blinded, crossover study whereby 13 patients with stable symptomatic PAD were randomized to undergo either 4 weeks of passive calf muscle stretching (ankle dorsiflexion applied 30 min/d, 5 days/wk) followed by 4 weeks of no muscle stretching and vice versa. Endothelium-dependent flow-mediated dilation (FMD) and endothelium-independent nitroglycerin-induced dilation of the popliteal artery and 6 minute walk test (6MWT) were evaluated at baseline and after each 4 week interval. RESULTS After 4 weeks of muscle stretching, FMD and 6MWT improved significantly in the muscle stretching group vs. the control (FMD: 5.1 ± 0.5% vs. 3.7 ± 0.3%, P = 0.005; 6MWT continuous walking distance: 304 ± 43 m vs. 182 ± 34 m; P = 0.0006). No difference in nitroglycerin-induced dilation was found between groups (10.9 ± 1.2 vs. 9.9 ± 0.4%, P = 0.48). Post-stretching, 6MWT total walking distance was positively correlated with normalized FMD (R = 0.645, P = 0.02). CONCLUSIONS Passive calf muscle stretching enhanced vascular endothelial function and improved walking function in elderly patients with stable symptomatic PAD. These findings merit further investigation in a prospective randomized trial.",2019,"Post-stretching, 6MWT total walking distance was positively correlated with normalized FMD (R = 0.645, P = 0.02). ","['elderly patients with stable symptomatic PAD', 'PAD patients', 'Patients with peripheral arterial disease (PAD', 'aged rats', 'elderly patients with stable symptomatic peripheral artery disease', '13 patients with stable symptomatic PAD']","['Passive calf muscle stretching', 'Daily passive muscle stretching', 'passive calf muscle stretching (ankle dorsiflexion applied 30\u202fmin/d, 5\u202fdays/wk) followed by 4\u202fweeks of no muscle stretching and vice versa']","['normalized FMD', '6MWT total walking distance', 'Endothelium-dependent flow-mediated dilation (FMD) and endothelium-independent nitroglycerin-induced dilation of the popliteal artery and 6\u202fminute walk test (6MWT', 'muscle stretching, FMD and 6MWT', 'walking function', 'nitroglycerin-induced dilation', 'vascular endothelial function']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0441601', 'cui_str': 'Padding (qualifier value)'}, {'cui': 'C1704436', 'cui_str': 'Peripheral Artery Disease'}, {'cui': 'C0034721', 'cui_str': 'Rats'}]","[{'cui': 'C0448482', 'cui_str': 'Posterior crural muscle structure'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0003086', 'cui_str': 'Regio tarsalis'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0429886', 'cui_str': 'Walking distance (observable entity)'}, {'cui': 'C0014257', 'cui_str': 'Endothelium'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}, {'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}, {'cui': 'C1322279', 'cui_str': 'Dilation'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0017887', 'cui_str': 'glyceryl trinitrate'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0032649', 'cui_str': 'Popliteal Artery'}, {'cui': 'C0430515', 'cui_str': '6-Minute Walk Test'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0031843', 'cui_str': 'function'}]",13.0,0.14241,"Post-stretching, 6MWT total walking distance was positively correlated with normalized FMD (R = 0.645, P = 0.02). ","[{'ForeName': 'Kazuki', 'Initials': 'K', 'LastName': 'Hotta', 'Affiliation': 'Department of Biomedical Sciences, Florida State University College of Medicine, Tallahassee, FL, USA; Department of Physical Therapy, Niigata University of Health and Welfare, Niigata, Japan.'}, {'ForeName': 'Wayne B', 'Initials': 'WB', 'LastName': 'Batchelor', 'Affiliation': 'Inova Heart and Vascular Institute, Falls Church, VA, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Graven', 'Affiliation': 'Tallahassee Memorial Healthcare, Tallahassee, FL, USA.'}, {'ForeName': 'Vishal', 'Initials': 'V', 'LastName': 'Dahya', 'Affiliation': 'Summa Health Medical Group, Akron, OH, USA.'}, {'ForeName': 'Thomas E', 'Initials': 'TE', 'LastName': 'Noel', 'Affiliation': 'Southern Medical Group, P.A., Tallahassee, FL, USA.'}, {'ForeName': 'Akash', 'Initials': 'A', 'LastName': 'Ghai', 'Affiliation': 'Southern Medical Group, P.A., Tallahassee, FL, USA.'}, {'ForeName': 'John N', 'Initials': 'JN', 'LastName': 'Katopodis', 'Affiliation': 'Southern Medical Group, P.A., Tallahassee, FL, USA.'}, {'ForeName': 'William C', 'Initials': 'WC', 'LastName': 'Dixon', 'Affiliation': 'Southern Medical Group, P.A., Tallahassee, FL, USA.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Andrews', 'Affiliation': 'Southern Medical Group, P.A., Tallahassee, FL, USA.'}, {'ForeName': 'Aimee', 'Initials': 'A', 'LastName': 'Pragle', 'Affiliation': 'Florida State University College of Medicine, Tallahassee, FL, USA.'}, {'ForeName': 'Jegghna', 'Initials': 'J', 'LastName': 'Chheda', 'Affiliation': 'Department of Nutrition, Food and Exercise Sciences, Florida State University College of Human Sciences, Tallahassee, FL, USA.'}, {'ForeName': 'Lia', 'Initials': 'L', 'LastName': 'Liberatore', 'Affiliation': 'Department of Nutrition, Food and Exercise Sciences, Florida State University College of Human Sciences, Tallahassee, FL, USA.'}, {'ForeName': 'Brad J', 'Initials': 'BJ', 'LastName': 'Behnke', 'Affiliation': 'Department of Kinesiology, Kansas State University College of Human Ecology, Manhattan, KS, USA.'}, {'ForeName': 'Judy', 'Initials': 'J', 'LastName': 'Muller-Delp', 'Affiliation': 'Department of Biomedical Sciences, Florida State University College of Medicine, Tallahassee, FL, USA. Electronic address: judy.delp@med.fsu.edu.'}]",Cardiovascular revascularization medicine : including molecular interventions,['10.1016/j.carrev.2019.05.003'] 1027,31099405,Genome-wide gene expression in a pharmacological hormonal transition model and its relation to depressive symptoms.,"OBJECTIVES Sensitivity to sex-steroid hormone fluctuations may increase risk for perinatal depression. We aimed to identify genome-wide biological profiles in women demonstrating sensitivity to pharmacological sex-hormone manipulation with gonadotrophin-releasing hormone agonist (GnRHa). METHODS Longitudinal gene expression (Illumina Human HT12.v4) and DNA methylation data (Infinium HumanMethylation450K BeadChip) from 60 women (30 GnRHa, 30 placebo) were generated (Trial ID: NCT02661789). Differences between baseline and two follow-up points (initial stimulation- and subsequent early suppression phase) in the biphasic ovarian hormone response to GnRHa were assessed using linear mixed effects models. RESULTS Genome-wide analysis revealed 588 probes differentially expressed from GnRHa intervention to first stimulatory phase follow-up (intervention group × time) after 10% fdr multiple testing correction. Of these, 54% genes were also significantly associated with estradiol changes over time (proxy for GnRHa response magnitude), 9.5% were associated with changes in depressive symptoms, and 38% were associated with changes in neocortical serotonin transporter binding. The genes were implicated in TGF beta signaling, adipogenesis, regulation of actin cytoskeleton, and focal adhesion pathways and enriched for DNA methylation changes (P = 0.006). CONCLUSIONS These findings point toward an altered peripheral blood transcriptomic landscape in a pharmacological model of sex-hormone-induced depressive symptoms.",2019,"We aimed to identify genome-wide biological profiles in women demonstrating sensitivity to pharmacological sex-hormone manipulation with gonadotrophin-releasing hormone agonist (GnRHa). ","['60 women (30 GnRHa, 30']","['gonadotrophin-releasing hormone agonist (GnRHa', 'placebo']","['estradiol changes over time (proxy for GnRHa response magnitude', 'depressive symptoms']","[{'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C0023610', 'cui_str': 'Gonadorelin'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C1700235', 'cui_str': '(11BAPOP2) estradiol'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0600420', 'cui_str': 'Proxy'}, {'cui': 'C1704240', 'cui_str': 'Magnitudes (qualifier value)'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}]",,0.0434277,"We aimed to identify genome-wide biological profiles in women demonstrating sensitivity to pharmacological sex-hormone manipulation with gonadotrophin-releasing hormone agonist (GnRHa). ","[{'ForeName': 'D', 'Initials': 'D', 'LastName': 'Mehta', 'Affiliation': 'School of Psychology and Counselling, Faculty of Health, Institute of Health and Biomedical Innovation, Queensland University of Technology, Kelvin Grove, Qld, Australia.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Rex-Haffner', 'Affiliation': 'Max Planck Institute of Psychiatry, Munich, Germany.'}, {'ForeName': 'H B', 'Initials': 'HB', 'LastName': 'Søndergaard', 'Affiliation': 'Danish Multiple Sclerosis Center, Copenhagen University Hospital Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Pinborg', 'Affiliation': 'Fertility Clinic, Copenhagen University Hospital Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'E B', 'Initials': 'EB', 'LastName': 'Binder', 'Affiliation': 'Max Planck Institute of Psychiatry, Munich, Germany.'}, {'ForeName': 'V G', 'Initials': 'VG', 'LastName': 'Frokjaer', 'Affiliation': 'Neurobiology Research Unit, Copenhagen University Hospital Rigshospitalet, Copenhagen, Denmark.'}]",Acta psychiatrica Scandinavica,['10.1111/acps.13038'] 1028,31145388,Effects of Maximal vs. Submaximal Isometric Fatiguing Exercise on Subsequent Submaximal Exercise Performance.,"Miller, WM, Ye, X, and Jeon, S. Effects of maximal vs. submaximal isometric fatiguing exercise on subsequent submaximal exercise performance. J Strength Cond Res 34(7): 1875-1883, 2020-Exercise-induced muscle fatigue directly influences subsequent exercise performance. Thus, we examined task failure times for submaximal intermittent fatiguing isometric contractions performed after a bout of sustained maximal vs. submaximal isometric fatiguing contractions with the dominant elbow flexors. Twenty physically active individuals 8 men (mean ± SD = 21.4 ± 1.8 years; 80.9 ± 12.5 kg; 180 ± 6.4 cm) and 12 women (mean ± SD = 21.4 ± 2.7; 66.8 ± 15.6 kg; 165.7 ± 7.1 cm) participated in a 3-visit randomized cross-over study. Visit 1 included familiarization, and 2 and 3 were randomized for sustained maximal (until force was below 50% of the maximal force value) or submaximal conditions (50% of maximal force until task failure), followed by submaximal intermittent isometric contractions to task failure. Surface electromyography was recorded through the biceps brachii during all fatiguing contractions. Task failure time was significantly shorter for the maximal compared with submaximal condition, and no significant difference in sex or condition was found for the subsequent fatiguing condition. Electromyography amplitude significantly increased in the submaximal intermittent isometric contractions from prefatigue and first and final postfatigue with no condition or sex differences. Electromyography mean frequency significantly decreased from prefatigue and first and final postfatigue for both sexes, with no condition or sex differences. With both maximal and submaximal exercises inducing the same level of force deficit, our results suggested that both exercises might have imposed a similar burden on the neuromuscular system, thereby not providing differential effects on the subsequent submaximal exercise performance.",2020,"Task failure time was significantly shorter for the maximal compared with submaximal condition, and no significant difference in sex or condition was found for the subsequent fatiguing condition.",['Twenty physically active individuals 8 men (mean ± SD = 21.4 ± 1.8 years; 80.9 ± 12.5 kg; 180 ± 6.4 cm) and 12 women (mean ± SD = 21.4 ± 2.7; 66.8 ± 15.6 kg; 165.7 ± 7.1 cm) participated in a 3-visit randomized cross-over study'],"['J Strength Cond Res XX(X', 'Maximal vs. Submaximal Isometric Fatiguing Exercise']","['Electromyography amplitude', 'Electromyography mean frequency', 'Task failure time', 'subsequent submaximal exercise performance', 'Subsequent Submaximal Exercise Performance']","[{'cui': 'C0556453', 'cui_str': 'Physically active (finding)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4068742', 'cui_str': '1.8'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517544', 'cui_str': '12.5 (qualifier value)'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C4517822', 'cui_str': '6.4 (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C4517635', 'cui_str': '2.7'}, {'cui': 'C4517844', 'cui_str': '66.8'}, {'cui': 'C0150097', 'cui_str': 'Crossover Trials'}]","[{'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0429340', 'cui_str': 'EMG amplitude'}, {'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]",20.0,0.027755,"Task failure time was significantly shorter for the maximal compared with submaximal condition, and no significant difference in sex or condition was found for the subsequent fatiguing condition.","[{'ForeName': 'William M', 'Initials': 'WM', 'LastName': 'Miller', 'Affiliation': 'Department of Health, Exercise Science, and Recreation Management, University of Mississippi, University, Mississippi.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Ye', 'Affiliation': ''}, {'ForeName': 'Sunggun', 'Initials': 'S', 'LastName': 'Jeon', 'Affiliation': ''}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000003200'] 1029,31141115,Comparison of Cinematic Rendering and Computed Tomography for Speed and Comprehension of Surgical Anatomy.,"Importance Three-dimensional (3-D) volume rendering has been shown to improve visualization in general surgery. Cinematic rendering (CR), a novel 3-D visualization technology for postprocessing of computed tomographaphy (CT) images, provides photorealistic images with the potential to improve visualization of anatomic details. Objective To determine the value of CR for the comprehension of the surgical anatomy. Design, Setting, and Participants This preclinical, randomized, 2-sequence crossover study was conducted from February to November 1, 2018, at University Hospital of Erlangen, Germany. The 40 patient cases were evaluated by 18 resident and attending surgeons using a prepared set of CT and CR images. The patient cases were randomized to 2 assessment sequences (CR-CT and CT-CR). During each assessment period, participants answered 1 question per case that addressed crucial issues of anatomic understanding, preoperative planning, and intraoperative strategies. After a washout period of 2 weeks, case evaluations were crossed over to the respective second image modality. Main Outcomes and Measures The primary outcome measure was the correctness of answers. Secondary outcome was the time needed to answer. Results The mean (SD) interperiod differences for the percentage of correct answers in the CR-CT sequence (8.5% [7.0%]) differed significantly from those in the CT-CR sequence (-13.1% [6.3%]) (P < .001). The mean (SD) interperiod differences for the time spent to answer the questions in the CR-CT sequence (-18.3 [76.9] seconds) also differed significantly from those in the CT-CR sequence (52.4 [88.5] seconds) (P < .001). Subgroup analysis revealed that residents as well as attending physicians benefitted from CR visualization. Analysis of the case assessment questionnaire showed that CR added significant value to the comprehension of the surgical anatomy (overall mean [SD] score, 4.53 [0.75]). No carryover or period effects were observed. Conclusions and Relevance The visualization with CR allowed a more correct and faster comprehension of the surgical anatomy compared with conventional CT imaging, independent of level of surgeon experience. Therefore, CR may assist general surgeons with preoperative preparation and intraoperative guidance.",2019,"The visualization with CR allowed a more correct and faster comprehension of the surgical anatomy compared with conventional CT imaging, independent of level of surgeon experience.","['February to November 1, 2018, at University Hospital of Erlangen, Germany', '40 patient cases were evaluated by 18 resident and attending surgeons using a prepared set of CT and CR images']","['Cinematic Rendering and Computed Tomography', 'Cinematic rendering (CR']","['CR-CT sequence', 'correctness of answers', 'time needed to answer']","[{'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0582175', 'cui_str': 'Surgeon (occupation)'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}]","[{'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0027552', 'cui_str': 'Needs'}]",,0.0666622,"The visualization with CR allowed a more correct and faster comprehension of the surgical anatomy compared with conventional CT imaging, independent of level of surgeon experience.","[{'ForeName': 'Moustafa', 'Initials': 'M', 'LastName': 'Elshafei', 'Affiliation': 'Department of Surgery, Universitätsklinikum Erlangen, Friedrich-Alexander-Universität Erlangen Nürnberg, Erlangen, Germany.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Binder', 'Affiliation': 'Department of Surgery, Universitätsklinikum Erlangen, Friedrich-Alexander-Universität Erlangen Nürnberg, Erlangen, Germany.'}, {'ForeName': 'Justus', 'Initials': 'J', 'LastName': 'Baecker', 'Affiliation': 'Department of Surgery, Universitätsklinikum Erlangen, Friedrich-Alexander-Universität Erlangen Nürnberg, Erlangen, Germany.'}, {'ForeName': 'Maximilian', 'Initials': 'M', 'LastName': 'Brunner', 'Affiliation': 'Department of Surgery, Universitätsklinikum Erlangen, Friedrich-Alexander-Universität Erlangen Nürnberg, Erlangen, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Uder', 'Affiliation': 'Institute of Radiology, Universitätsklinikum Erlangen, Friedrich-Alexander-Universität Erlangen Nürnberg, Erlangen, Germany.'}, {'ForeName': 'Georg F', 'Initials': 'GF', 'LastName': 'Weber', 'Affiliation': 'Department of Surgery, Universitätsklinikum Erlangen, Friedrich-Alexander-Universität Erlangen Nürnberg, Erlangen, Germany.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Grützmann', 'Affiliation': 'Department of Surgery, Universitätsklinikum Erlangen, Friedrich-Alexander-Universität Erlangen Nürnberg, Erlangen, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Krautz', 'Affiliation': 'Department of Surgery, Universitätsklinikum Erlangen, Friedrich-Alexander-Universität Erlangen Nürnberg, Erlangen, Germany.'}]",JAMA surgery,['10.1001/jamasurg.2019.1168'] 1030,31746075,Behavioral couples therapy versus cognitive behavioral therapy for problem gambling: a randomized controlled trial.,,2020,"The outcomes of both gambler groups improved, and differences between the groups were not statistically significant:","['Stockholm, Sweden', 'gamblers were on average 35.6 years old and 18.4% were female', 'Problem Gambling', 'A total of 136 problem gamblers and 136 CSOs were included in the study: 68 gamblers and 68 CSOs for each treatment condition']","['Internet-based behavioral couples therapy and cognitive behavioral therapy', 'Behavioral Couples Therapy vs. Cognitive Behavioral Therapy', 'cognitive behavioral therapy (CBT', 'behavioral couples therapy (BCT) and CBT']","['CSOs', 'Time-Line Follow-Back for Gambling (TLFB-G), and the NORC Diagnostic Screen for Gambling Problems (NODS) for problem gamblers, corresponding to DSM-IV criteria for Pathological Gambling', 'Patient Health Questionnaire-9 (PHQ-9), The Generalized Anxiety Disorder 7-item scale (GAD-7), The Relation Assessment Scale Generic (RAS-G), The Alcohol Use Disorders Identification Test (AUDIT), The Inventory of Consequences of Gambling for the Gambler and CSO (ICS), and adherence to treatment for both the problem gambler and the CSO']","[{'cui': 'C0038995', 'cui_str': 'Sweden'}, {'cui': 'C0858352', 'cui_str': 'Gambler'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0016995', 'cui_str': 'Gamblings'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4517568', 'cui_str': 'One hundred and thirty-six'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0302822', 'cui_str': 'Couples Therapy'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}]","[{'cui': 'C0451543', 'cui_str': 'Time line follow back (assessment scale)'}, {'cui': 'C0016995', 'cui_str': 'Gamblings'}, {'cui': 'C0348026', 'cui_str': 'Diagnostic'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0858352', 'cui_str': 'Gambler'}, {'cui': 'C0220952', 'cui_str': 'DSM-IV'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0030662', 'cui_str': 'Gambling, Pathologic'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0003469', 'cui_str': 'Anxiety Disorders'}, {'cui': 'C0222045'}, {'cui': 'C3641330', 'cui_str': 'GAD-7'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales (assessment scale)'}, {'cui': 'C0450985', 'cui_str': 'Alcohol use disorders identification test (assessment scale)'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0686907', 'cui_str': 'Consequence of (contextual qualifier) (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]",136.0,0.0941086,"The outcomes of both gambler groups improved, and differences between the groups were not statistically significant:","[{'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Nilsson', 'Affiliation': 'Department of Clinical Neuroscience, Stockholm Center for Psychiatry Research and Education, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Kristoffer', 'Initials': 'K', 'LastName': 'Magnusson', 'Affiliation': 'Department of Clinical Neuroscience, Stockholm Center for Psychiatry Research and Education, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Carlbring', 'Affiliation': 'Department of Psychology, Stockholm University, Stockholm, Sweden.'}, {'ForeName': 'Gerhard', 'Initials': 'G', 'LastName': 'Andersson', 'Affiliation': 'Department of Clinical Neuroscience, Stockholm Center for Psychiatry Research and Education, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Clara', 'Initials': 'C', 'LastName': 'Hellner', 'Affiliation': 'Department of Clinical Neuroscience, Stockholm Center for Psychiatry Research and Education, Karolinska Institutet, Stockholm, Sweden.'}]","Addiction (Abingdon, England)",['10.1111/add.14900'] 1031,31178421,"Inhaled hypertonic saline in preschool children with cystic fibrosis (SHIP): a multicentre, randomised, double-blind, placebo-controlled trial.","BACKGROUND Inhaled hypertonic saline enhances mucociliary clearance, improves lung function, and reduces pulmonary exacerbations in people with cystic fibrosis older than age 6 years. We aimed to assess the effect of inhaled hypertonic saline on the lung clearance index (LCI 2·5 )-a measure of ventilation inhomogeneity-in children aged 3-6 years with cystic fibrosis. METHODS The Saline Hypertonic in Preschoolers (SHIP) Study was a randomised, double-blind, placebo-controlled trial at 25 cystic fibrosis centres in Canada and the USA. Eligible participants were aged 36-72 months; had a confirmed diagnosis of cystic fibrosis; were able to comply with medication use, study visits, and study procedures; and were able to complete at least two technically acceptable trials of multiple breath washout (MBW). Participants were randomly assigned (1:1) via a web-based data entry system that confirmed enrolment eligibility to inhaled 7% hypertonic saline or 0·9% isotonic saline nebulised twice daily (for no more than 15 min per dose) for 48 weeks. Permuted block randomisation was done separately for participants aged 36-54 months and those aged 55-72 months to ensure approximate balance by treatment group in the two age groups. The primary endpoint was the change in the LCI 2·5 measured by nitrogen MBW from baseline to week 48. All study sites were trained and certified in MBW. Analysis was by intention to treat. This study is registered with Clinicaltrials.gov, number NCT02378467. FINDINGS Between April 21, 2015, and Aug 4, 2017, 150 participants were enrolled and randomly assigned, 76 to the hypertonic saline group and 74 to the isotonic saline group. Overall 89% of the MBW tests produced acceptable data. At 48 weeks, treatment with hypertonic saline was associated with a significant decrease (ie, improvement) in LCI 2·5 compared with isotonic saline (mean treatment effect -0·63 LCI 2·5 units [95% CI -1·10 to -0·15]; p=0·010). Six participants in the hypertonic saline group had ten serious adverse events and eight participants in the isotonic saline group had nine serious adverse events. The serious adverse events reported were cough (two patients [3%] in the hypertonic saline group vs three [4%] in the isotonic saline group), gastrostomy tube placement or rupture (two [3%] vs one [1%]), upper gastrointestinal disorders (one [1%] vs two [3%]), distal intestinal obstruction syndrome (one [1%] vs one [1%]), and decreased pulmonary function (none vs one [1%]). None of these serious adverse events was judged to be treatment related. INTERPRETATION Inhaled hypertonic saline improved the LCI 2·5 in children aged 3-6 years, and could be a suitable early intervention in cystic fibrosis. FUNDING Cystic Fibrosis Foundation.",2019,"At 48 weeks, treatment with hypertonic saline was associated with a significant decrease (ie, improvement) in LCI 2·5 compared with isotonic saline (mean treatment effect -0·63","['people with cystic fibrosis older than age 6 years', 'participants aged 36-54 months and those aged 55-72 months to ensure approximate balance by treatment group in the two age groups', 'preschool children with cystic fibrosis (SHIP', 'Eligible participants were aged 36-72 months; had a confirmed diagnosis of cystic fibrosis', 'Between April 21, 2015, and Aug 4, 2017, 150 participants were enrolled and randomly assigned, 76 to the', 'children aged 3-6 years with cystic fibrosis', 'children aged 3-6 years', '25 cystic fibrosis centres in Canada and the USA']","['inhaled hypertonic saline', 'placebo', 'isotonic saline', 'hypertonic saline or 0·9% isotonic saline nebulised twice daily', 'hypertonic saline', 'Saline Hypertonic', 'Inhaled hypertonic saline']","['pulmonary exacerbations', 'pulmonary function', 'gastrostomy tube placement or rupture', 'nine serious adverse events', 'upper gastrointestinal disorders', 'change in the LCI 2·5 measured by nitrogen MBW', 'serious adverse events', 'lung clearance index (LCI 2·5 )-a measure of ventilation inhomogeneity', 'distal intestinal obstruction syndrome']","[{'cui': 'C0010674', 'cui_str': 'Mucoviscidosis'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0332232', 'cui_str': 'Approximate (qualifier value)'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0027362', 'cui_str': 'Age Groups'}, {'cui': 'C0008100', 'cui_str': 'Child, Preschool'}, {'cui': 'C0036971', 'cui_str': 'Ships'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0006823', 'cui_str': 'Canada'}]","[{'cui': 'C0004048', 'cui_str': 'Inhalation'}, {'cui': 'C0036085', 'cui_str': 'Sodium Chloride Solution, Hypertonic'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}]","[{'cui': 'C4522268', 'cui_str': 'Pulmonary'}, {'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C0150595', 'cui_str': 'Gastrostomy tube (physical object)'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0443294', 'cui_str': 'Ruptured (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0810300', 'cui_str': 'Upper gastrointestinal disorder'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0231990', 'cui_str': 'Lung clearance index (observable entity)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0028158', 'cui_str': 'Nitrogen'}, {'cui': 'C2945579', 'cui_str': 'Ventilation, function (observable entity)'}, {'cui': 'C0398349', 'cui_str': 'Distal intestinal obstruction syndrome (disorder)'}]",150.0,0.616061,"At 48 weeks, treatment with hypertonic saline was associated with a significant decrease (ie, improvement) in LCI 2·5 compared with isotonic saline (mean treatment effect -0·63","[{'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Ratjen', 'Affiliation': 'Division of Respiratory Medicine, Department of Pediatrics, The Hospital for Sick Children, Toronto, ON Canada; University of Toronto, Toronto, ON, Canada; Translational Medicine, Research Institute, SickKids, Toronto, ON, Canada. Electronic address: felix.ratjen@sickkids.ca.'}, {'ForeName': 'Stephanie D', 'Initials': 'SD', 'LastName': 'Davis', 'Affiliation': 'Division of Pediatric Pulmonology, Department of Pediatrics, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Sanja', 'Initials': 'S', 'LastName': 'Stanojevic', 'Affiliation': 'University of Toronto, Toronto, ON, Canada; Translational Medicine, Research Institute, SickKids, Toronto, ON, Canada.'}, {'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Kronmal', 'Affiliation': 'Collaborative Health Studies Coordinating Center, Department of Biostatistics, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Karen D', 'Initials': 'KD', 'LastName': 'Hinckley Stukovsky', 'Affiliation': 'Collaborative Health Studies Coordinating Center, Department of Biostatistics, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Neal', 'Initials': 'N', 'LastName': 'Jorgensen', 'Affiliation': 'Collaborative Health Studies Coordinating Center, Department of Biostatistics, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Rosenfeld', 'Affiliation': ""Division of Pulmonary Medicine, Seattle Children's Hospital, Seattle, WA, USA; Department of Pediatrics, University of Washington School of Medicine, Seattle, WA, USA.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Respiratory medicine,['10.1016/S2213-2600(19)30187-0'] 1032,31758326,Utility of topical agents for radiation dermatitis and pain: a randomized clinical trial.,"PURPOSE Although topical agents are often provided during radiation therapy, there is limited consensus and evidence for their use prophylactically to prevent or reduce radiation dermatitis. METHODS This was a multi-site, randomized, placebo-controlled, blinded study of 191 breast cancer patients to compare the prophylactic effectiveness of three topical agents (Curcumin, HPR Plus™, and Placebo) for reducing radiation dermatitis and associated pain. Patients applied the topical agent to their skin in the radiation area site three times daily starting the first day of radiation therapy (RT) until 1 week after RT completion. RESULTS Of the 191 randomized patients, 171 patients were included in the final analyses (87.5% white females, mean age = 58 (range = 36-88)). Mean radiation dermatitis severity (RDS) scores did not significantly differ between study arms (Curcumin = 2.68 [2.49, 2.86]; HPR Plus™ = 2.64 [2.45, 2.82]; Placebo = 2.63 [2.44, 2.83]; p = 0.929). Logistic regression analyses showed that increased breast field separation positively correlated with increased radiation dermatitis severity (p = 0.018). In patients with high breast field separation (≥ 25 cm), RDS scores (Curcumin = 2.70 [2.21, 3.19]; HPR Plus™ = 3.57 [3.16, 4.00]; Placebo = 2.95 [2.60, 3.30]; p = 0.024) and pain scores (Curcumin = 0.52 [- 0.28, 1.33]; HPR Plus™ = 0.55 [- 0.19, 1.30]; Placebo = 1.73 [0.97, 2.50]; p = 0.046) significantly differed at the end of RT. CONCLUSIONS Although there were no significant effects of the treatment groups on the overall population, our exploratory subgroup analysis suggests that prophylactic treatment with topical curcumin may be effective for minimizing skin reactions and pain for patients with high breast separation (≥ 25 cm) who may have the worst skin reactions.",2020,Logistic regression analyses showed that increased breast field separation positively correlated with increased radiation dermatitis severity (p = 0.018).,"['radiation dermatitis and pain', '191 breast cancer patients', '191 randomized patients', '171 patients were included in the final analyses (87.5% white females, mean age = 58 (range = 36-88', 'patients with high breast separation (≥ 25 cm) who may have the worst skin reactions']","['placebo', 'topical agents', 'topical agents (Curcumin, HPR Plus™, and Placebo']","['pain scores', 'RDS scores', 'radiation dermatitis severity', 'prophylactic effectiveness', 'Mean radiation dermatitis severity (RDS) scores', 'skin reactions and pain', 'radiation dermatitis and associated pain']","[{'cui': 'C0034561', 'cui_str': 'Radiation-Induced Dermatitis'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C4517896', 'cui_str': '87.5'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0006141', 'cui_str': 'Breast'}, {'cui': 'C0237868', 'cui_str': 'Separation'}, {'cui': 'C0423754', 'cui_str': 'Poor skin condition (finding)'}, {'cui': 'C0443286', 'cui_str': 'Reaction (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0450442', 'cui_str': 'Agent (attribute)'}, {'cui': 'C0010467', 'cui_str': 'Curcumin'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0034561', 'cui_str': 'Radiation-Induced Dermatitis'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0445202', 'cui_str': 'Prophylactic (qualifier value)'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0457451', 'cui_str': 'Severity score (qualifier value)'}, {'cui': 'C0221743', 'cui_str': 'Skin reaction (observable entity)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",191.0,0.2804,Logistic regression analyses showed that increased breast field separation positively correlated with increased radiation dermatitis severity (p = 0.018).,"[{'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Ryan Wolf', 'Affiliation': 'Department of Dermatology, University of Rochester Medical Center, 601 Elmwood Ave, Box 697, Rochester, NY, 14642, USA. julie_ryan@urmc.rochester.edu.'}, {'ForeName': 'Jennifer S', 'Initials': 'JS', 'LastName': 'Gewandter', 'Affiliation': 'Department of Anesthesiology, University of Rochester Medical Center, Rochester, NY, USA.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Bautista', 'Affiliation': 'URCC NCORP Research Base, University of Rochester Medical Center, Rochester, NY, USA.'}, {'ForeName': 'Charles E', 'Initials': 'CE', 'LastName': 'Heckler', 'Affiliation': 'URCC NCORP Research Base, University of Rochester Medical Center, Rochester, NY, USA.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Strasser', 'Affiliation': 'Delaware/Christiana Care NCORP, Newark, DE, USA.'}, {'ForeName': 'Pawal', 'Initials': 'P', 'LastName': 'Dyk', 'Affiliation': 'Heartland Cancer Research NCORP, St. Louis, MO, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Anderson', 'Affiliation': 'Columbus NCORP, Columbus, OH, USA.'}, {'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'Gross', 'Affiliation': 'Dayton Clinical Oncology Program, Dayton, OH, USA.'}, {'ForeName': 'Tod', 'Initials': 'T', 'LastName': 'Speer', 'Affiliation': 'Metro-Minnesota NCORP, St. Louis Park, MN, USA.'}, {'ForeName': 'Lindsey', 'Initials': 'L', 'LastName': 'Dolohanty', 'Affiliation': 'Department of Dermatology, University of Rochester Medical Center, 601 Elmwood Ave, Box 697, Rochester, NY, 14642, USA.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Bylund', 'Affiliation': 'Department Radiation Oncology, University of Rochester Medical Center, Rochester, NY, USA.'}, {'ForeName': 'Alice P', 'Initials': 'AP', 'LastName': 'Pentland', 'Affiliation': 'Department of Dermatology, University of Rochester Medical Center, 601 Elmwood Ave, Box 697, Rochester, NY, 14642, USA.'}, {'ForeName': 'Gary R', 'Initials': 'GR', 'LastName': 'Morrow', 'Affiliation': 'URCC NCORP Research Base, University of Rochester Medical Center, Rochester, NY, USA.'}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-019-05166-5'] 1033,31129484,Acute and long-term cannabis use among stimulant users: Results from CTN-0037 Stimulant Reduction Intervention using Dosed Exercise (STRIDE) Randomized Control Trial.,"AIMS The aim of this study was to examine the impact of vigorous intensity, high dose exercise (DEI) on cannabis use among stimulant users compared to a health education intervention (HEI) using data from the Stimulant Reduction Intervention using Dosed Exercise, National Institute of Drug Abuse National Drug Treatment Clinical Trials Network Protocol Number 0037 (STRIDE). METHODS Adults (N = 302) enrolled in the STRIDE randomized clinical trial were randomized to either the DEI or the HEI. Interventions included supervised sessions three times a week during the Acute phase (12 weeks) and once a week during the Follow-up phase (6 months). Cannabis use was measured at each assessment via Timeline Follow Back and urine drug screens. Cannabis use was compared between the groups during the Acute and Follow-up phases using both the intent-to-treat sample and a complier average causal effects (CACE) analysis. FINDINGS Approximately 43% of the sample reported cannabis use at baseline. The difference in cannabis use between the DEI and HEI groups during the Acute phase was not significant. During the Follow-up phase, the days of cannabis use was significantly lower among those in the DEI group (1.20 days) compared to the HEI group (2.15 days; p = 0.04). CONCLUSIONS For those who adhered to the exercise intervention, vigorous intensity, high dose exercise resulted in less cannabis use. Results suggest that there were no significant short-term differences in cannabis use between the groups. Further study on the long-term impact of exercise as a treatment to reduce cannabis use should be considered.",2019,The difference in cannabis use between the DEI and HEI groups during the Acute phase was not significant.,['Adults (N\u2009=\u2009302) enrolled'],"['health education intervention (HEI', 'vigorous intensity, high dose exercise (DEI', 'DEI or the HEI', 'CTN-0037 Stimulant Reduction Intervention using Dosed Exercise (STRIDE']",[],"[{'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0018701'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0917591', 'cui_str': 'CTN'}, {'cui': 'C0242977', 'cui_str': 'Stimulants, Historical'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}]",[],302.0,0.0819698,The difference in cannabis use between the DEI and HEI groups during the Acute phase was not significant.,"[{'ForeName': 'Denise C', 'Initials': 'DC', 'LastName': 'Vidot', 'Affiliation': 'University of Miami School of Nursing and Health Studies, 5030 Brunson Ave., Coral Gables, FL 33146, USA. Electronic address: DVidot@miami.edu.'}, {'ForeName': 'Chad D', 'Initials': 'CD', 'LastName': 'Rethorst', 'Affiliation': 'The University of Texas Southwestern Medical Center, Department of Psychiatry, 5323 Harry Hines Blvd., Dallas, TX 75290, USA.'}, {'ForeName': 'Tom J', 'Initials': 'TJ', 'LastName': 'Carmody', 'Affiliation': 'The University of Texas Southwestern Medical Center, Department of Psychiatry, 5323 Harry Hines Blvd., Dallas, TX 75290, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Stoutenberg', 'Affiliation': 'University of Tennessee at Chattanooga, 615 McCallie Ave., Chattanooga, TN 37403, USA.'}, {'ForeName': 'Robrina', 'Initials': 'R', 'LastName': 'Walker', 'Affiliation': 'The University of Texas Southwestern Medical Center, Department of Psychiatry, 5323 Harry Hines Blvd., Dallas, TX 75290, USA.'}, {'ForeName': 'Tracy L', 'Initials': 'TL', 'LastName': 'Greer', 'Affiliation': 'The University of Texas Southwestern Medical Center, Department of Psychiatry, 5323 Harry Hines Blvd., Dallas, TX 75290, USA.'}, {'ForeName': 'Madhukar H', 'Initials': 'MH', 'LastName': 'Trivedi', 'Affiliation': 'The University of Texas Southwestern Medical Center, Department of Psychiatry, 5323 Harry Hines Blvd., Dallas, TX 75290, USA.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2019.02.032'] 1034,31146613,"The Novel Effects of a Hydrolyzed Polysaccharide Dietary Supplement on Immune, Hepatic, and Renal Function in Adults with HIV in a Randomized, Double-Blind, Placebo-Control Trial.","The primary objective of the study was to evaluate the effects of a hydrolyzed polysaccharide, rice bran arabinoxylan compound (RBAC), on immune, hepatic, and renal function in HIV + individuals. A 6-month randomized double-blind placebo-controlled trial was utilized to conduct the intervention. Forty-seven HIV + individuals on stable antiretroviral therapy were enrolled and randomly assigned to one of the 2 study conditions ( n  = 22 RBAC and n  = 25 placebo) and consumed 3 gram/day of either compound for 6 months. Participants were assessed at baseline and 3 and 6 months follow-up for CD4+ and CD8+, liver enzymes, and kidney function. No side effects were reported, and liver and kidney markers remained nearly completely within normal limits. The percentage change in CD4+ was similar for the placebo (+2.2%) and RBAC (+3.1%) groups at 6 months follow-up. The percentage change in CD8+ count significantly decreased from baseline to 6 months in the RBAC group (-5.2%), whereas it increased in the placebo group (+57.8%; p  = 0.04). The CD4+/CD8+ ratio improved clinically in the RBAC group from 0.95 (SD = 0.62) at baseline to 1.07 (SD = 0.11) at 6 months, whereas it declined in the placebo group from 0.96 (SD = 0.80) at baseline to 0.72 (SD = 0.59) at 6 months. Our results showed a statistically significant decrease in CD8+ count and a clinically significant increase in CD4+/CD8+ ratio for the RBAC group compared to the placebo group. Thus, the results of this study suggest that the immunomodulatory and antisenescent activities of RBAC are promising for the HIV population.",2020,"The percentage change in CD8+ count significantly decreased from baseline to 6 months in the RBAC group (-5.2%), whereas it increased in the placebo group (+57.8%; p  = 0.04).","['Adults with HIV', 'HIV\u2009+\u2009individuals', 'Forty-seven HIV\u2009+\u2009individuals on stable antiretroviral therapy']","['RBAC and n \u2009=\u200925 placebo', 'placebo', 'hydrolyzed polysaccharide, rice bran arabinoxylan compound (RBAC', 'Placebo', 'Hydrolyzed Polysaccharide Dietary Supplement']","['Immune, Hepatic, and Renal Function', 'CD8+ count', 'percentage change in CD8+ count', 'liver and kidney markers', 'CD4+ and CD8+, liver enzymes, and kidney function', 'CD4+/CD8+ ratio', 'immune, hepatic, and renal function', 'percentage change in CD4']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0032594', 'cui_str': 'Glycans'}, {'cui': 'C3810876', 'cui_str': 'Rice bran'}, {'cui': 'C0250438', 'cui_str': 'arabinoxylan'}, {'cui': 'C0205198', 'cui_str': 'Compound (qualifier value)'}, {'cui': 'C0242295', 'cui_str': 'Dietary Supplementations'}]","[{'cui': 'C0439662', 'cui_str': 'Immune (qualifier value)'}, {'cui': 'C0232804', 'cui_str': 'Renal function (observable entity)'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C0022646', 'cui_str': 'Kidney'}, {'cui': 'C0443764', 'cui_str': 'Liver enzyme (substance)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",,0.387552,"The percentage change in CD8+ count significantly decreased from baseline to 6 months in the RBAC group (-5.2%), whereas it increased in the placebo group (+57.8%; p  = 0.04).","[{'ForeName': 'John E', 'Initials': 'JE', 'LastName': 'Lewis', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Miami Miller School of Medicine, Miami, FL, USA.'}, {'ForeName': 'Steven E', 'Initials': 'SE', 'LastName': 'Atlas Bsn', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Miami Miller School of Medicine, Miami, FL, USA.'}, {'ForeName': 'Muhammad H', 'Initials': 'MH', 'LastName': 'Abbas', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Miami Miller School of Medicine, Miami, FL, USA.'}, {'ForeName': 'Ammar', 'Initials': 'A', 'LastName': 'Rasul', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Miami Miller School of Medicine, Miami, FL, USA.'}, {'ForeName': 'Ashar', 'Initials': 'A', 'LastName': 'Farooqi', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Miami Miller School of Medicine, Miami, FL, USA.'}, {'ForeName': 'Laura A', 'Initials': 'LA', 'LastName': 'Lantigua', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Miami Miller School of Medicine, Miami, FL, USA.'}, {'ForeName': 'Frederick', 'Initials': 'F', 'LastName': 'Michaud', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Miami Miller School of Medicine, Miami, FL, USA.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Goldberg', 'Affiliation': 'Glow Health, PA, Bay Harbor Islands, FL, USA.'}, {'ForeName': 'Lucas C', 'Initials': 'LC', 'LastName': 'Lages', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Miami Miller School of Medicine, Miami, FL, USA.'}, {'ForeName': 'Oscar L', 'Initials': 'OL', 'LastName': 'Higuera', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Miami Miller School of Medicine, Miami, FL, USA.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Fiallo', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Miami Miller School of Medicine, Miami, FL, USA.'}, {'ForeName': 'Eduard', 'Initials': 'E', 'LastName': 'Tiozzo', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Miami Miller School of Medicine, Miami, FL, USA.'}, {'ForeName': 'Judi M', 'Initials': 'JM', 'LastName': 'Woolger', 'Affiliation': 'Department of Medicine, University of Miami Miller School of Medicine, Miami, FL, USA.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Ciraula', 'Affiliation': 'Department of Medicine, University of Miami Miller School of Medicine, Miami, FL, USA.'}, {'ForeName': 'Armando', 'Initials': 'A', 'LastName': 'Mendez', 'Affiliation': 'Department of Medicine, University of Miami Miller School of Medicine, Miami, FL, USA.'}, {'ForeName': 'Allan', 'Initials': 'A', 'LastName': 'Rodriguez', 'Affiliation': 'Department of Medicine, University of Miami Miller School of Medicine, Miami, FL, USA.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Konefal', 'Affiliation': 'Department of Family Medicine and Community Health, University of Miami Miller School of Medicine, Miami, FL, USA.'}]",Journal of dietary supplements,['10.1080/19390211.2019.1619010'] 1035,31743238,"Effects of Virtual Exercise Rehabilitation In-Home Therapy Compared with Traditional Care After Total Knee Arthroplasty: VERITAS, a Randomized Controlled Trial.","BACKGROUND Financial burden for patients, providers, and payers can reduce access to physical therapy (PT) after total knee arthroplasty (TKA). The purpose of the present study was to examine the effect of a virtual PT program on health-care costs and clinical outcomes as compared with traditional care after TKA. METHODS At least 10 days before unilateral TKA, patients from 4 clinical sites were enrolled and randomized 1:1 to the virtual PT program (involving an avatar [digitally simulated] coach, in-home 3-dimensional biometrics, and telerehabilitation with remote clinician oversight by a physical therapist) or to traditional PT care in the home or outpatient clinic. The primary outcome was total health-care costs for the 12-week post-hospital period. Secondary (noninferiority) outcomes included 6 and 12-week Knee injury and Osteoarthritis Outcome Score (KOOS); 6-week knee extension, knee flexion, and gait speed; and 12-week safety measures (patient-reported falls, pain, and hospital readmissions). All outcomes were analyzed on a modified intent-to-treat basis. RESULTS Of 306 patients (mean age, 65 years; 62.5% women) who were randomized from November 2016 to November 2017, 290 had TKA and 287 (including 143 in the virtual PT group and 144 in the usual care group) completed the trial. Virtual PT had lower costs at 12 weeks after discharge than usual care (median, $1,050 compared with $2,805; p < 0.001). Mean costs were $2,745 lower for virtual PT patients. Virtual PT patients had fewer rehospitalizations than the usual care group (12 compared with 30; p = 0.007). Virtual PT was noninferior to usual PT in terms of the KOOS at 6 weeks (difference, 0.77; 90% confidence interval [CI], -1.68 to 3.23) and 12 weeks (difference, -2.33; 90% CI, -4.98 to 0.31). Virtual PT was also noninferior to usual care at 6 weeks in terms of knee extension, knee flexion, and gait speed and at 12 weeks in terms of pain and hospital readmissions. Falls were reported by 19.4% of virtual PT patients and 14.6% of usual care patients (difference, 4.83%; 90% CI, -2.60 to 12.25). CONCLUSIONS Relative to traditional home or clinic PT, virtual PT with telerehabilitation for skilled clinical oversight significantly lowered 3-month health-care costs after TKA while providing similar effectiveness. These findings have important implications for patients, health systems, and payers. Virtual PT with clinical oversight should be considered for patients managed with TKA. LEVEL OF EVIDENCE Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.",2020,"Virtual PT was also noninferior to usual care at 6 weeks in terms of knee extension, knee flexion, and gait speed and at 12 weeks in terms of pain and hospital readmissions.","['306 patients (mean age, 65 years; 62.5% women) who were randomized from November 2016 to November 2017', ' 290 had TKA and 287 (including 143 in the virtual PT group and 144 in the usual care group', 'patients managed with TKA', 'After Total Knee Arthroplasty']","['Virtual Exercise Rehabilitation', 'virtual PT program (involving an avatar [digitally simulated] coach, in-home 3-dimensional biometrics, and telerehabilitation with remote clinician oversight by a physical therapist) or to traditional PT care in the home or outpatient clinic', 'virtual PT program', 'Traditional Care']","['health-care costs and clinical outcomes', '6 and 12-week Knee injury and Osteoarthritis Outcome Score (KOOS); 6-week knee extension, knee flexion, and gait speed; and 12-week safety measures (patient-reported falls, pain, and hospital readmissions', 'Falls', 'Mean costs', 'total health-care costs']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517836', 'cui_str': '62.5'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C4517682', 'cui_str': '287 (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C4517573', 'cui_str': 'One hundred and forty-three'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C0557773', 'cui_str': 'Coach (physical object)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0450363', 'cui_str': 'Three-dimensional (qualifier value)'}, {'cui': 'C4042802', 'cui_str': 'Tele-rehabilitation'}, {'cui': 'C0205157', 'cui_str': 'Remote (qualifier value)'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapists'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0002424', 'cui_str': 'Outpatient Clinics'}]","[{'cui': 'C0085552', 'cui_str': 'Healthcare Costs'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0022744', 'cui_str': 'Knee Injuries'}, {'cui': 'C0029408', 'cui_str': 'Arthritis, Degenerative'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C0231452', 'cui_str': 'Flexion, function (observable entity)'}, {'cui': 'C2009910', 'cui_str': 'Gait Speed'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0000921', 'cui_str': 'Falls'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0600290', 'cui_str': 'Hospital Readmissions'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]",306.0,0.0986448,"Virtual PT was also noninferior to usual care at 6 weeks in terms of knee extension, knee flexion, and gait speed and at 12 weeks in terms of pain and hospital readmissions.","[{'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Prvu Bettger', 'Affiliation': 'Departments of Orthopaedic Surgery (J.P.B., R.C.M., and T.M.S.) and Physical and Occupational Therapy (B.T.H. and A.J.d.L.), Duke University, Durham, North Carolina.'}, {'ForeName': 'Cynthia L', 'Initials': 'CL', 'LastName': 'Green', 'Affiliation': 'Duke Clinical Research Institute, Durham, North Carolina.'}, {'ForeName': 'DaJuanicia N', 'Initials': 'DN', 'LastName': 'Holmes', 'Affiliation': 'Duke Clinical Research Institute, Durham, North Carolina.'}, {'ForeName': 'Anang', 'Initials': 'A', 'LastName': 'Chokshi', 'Affiliation': 'Reflexion Health, San Diego, California.'}, {'ForeName': 'Richard C', 'Initials': 'RC', 'LastName': 'Mather', 'Affiliation': 'Departments of Orthopaedic Surgery (J.P.B., R.C.M., and T.M.S.) and Physical and Occupational Therapy (B.T.H. and A.J.d.L.), Duke University, Durham, North Carolina.'}, {'ForeName': 'Bryan T', 'Initials': 'BT', 'LastName': 'Hoch', 'Affiliation': 'Departments of Orthopaedic Surgery (J.P.B., R.C.M., and T.M.S.) and Physical and Occupational Therapy (B.T.H. and A.J.d.L.), Duke University, Durham, North Carolina.'}, {'ForeName': 'Arthur J', 'Initials': 'AJ', 'LastName': 'de Leon', 'Affiliation': 'Departments of Orthopaedic Surgery (J.P.B., R.C.M., and T.M.S.) and Physical and Occupational Therapy (B.T.H. and A.J.d.L.), Duke University, Durham, North Carolina.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Aluisio', 'Affiliation': 'Greensboro Orthopaedics, Greensboro, North Carolina.'}, {'ForeName': 'Thorsten M', 'Initials': 'TM', 'LastName': 'Seyler', 'Affiliation': 'Departments of Orthopaedic Surgery (J.P.B., R.C.M., and T.M.S.) and Physical and Occupational Therapy (B.T.H. and A.J.d.L.), Duke University, Durham, North Carolina.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Del Gaizo', 'Affiliation': 'University of North Carolina at Chapel Hill Orthopaedics, Chapel Hill, North Carolina.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Chiavetta', 'Affiliation': 'Raleigh Orthopaedics, Raleigh, North Carolina.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Webb', 'Affiliation': 'Duke Clinical Research Institute, Durham, North Carolina.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Miller', 'Affiliation': 'Duke Clinical Research Institute, Durham, North Carolina.'}, {'ForeName': 'Joseph M', 'Initials': 'JM', 'LastName': 'Smith', 'Affiliation': 'Reflexion Health, San Diego, California.'}, {'ForeName': 'Eric D', 'Initials': 'ED', 'LastName': 'Peterson', 'Affiliation': 'Duke Clinical Research Institute, Durham, North Carolina.'}]",The Journal of bone and joint surgery. American volume,['10.2106/JBJS.19.00695'] 1036,31100345,Interaction of task-related learning and transcranial direct current stimulation of the prefrontal cortex in modulating executive functions.,"The effects of transcranial direct-current stimulation (tDCS) on cognitive functions, such as response inhibition, might be mediated through plastic changes within the prefrontal cortex. Previous studies have also confirmed learning-related plasticity in prefrontal neurocircuitry. The susceptibility of prefrontal neurocircuitry for tDCS-induced plastic changes and consequent behavioural modulations might depend on the level of learning in a particular task. Variabilities in the cognitive outcome of tDCS might be related to the interaction of tDCS and task-relevant learning. 73 participants completed the Stop Task before and after tDCS over the dorsolateral prefrontal cortex. Participants had to deliver a speeded response upon the onset of a visual go-cue and inhibit the response when the go-cue was replaced by a stop signal. We measured response time (RT) in Go trials, and stop signal reaction time (SSRT) as an index of inhibition ability. A shorter SSRT indicates a better inhibition ability. Participants received either anodal or sham stimulation in two separate sessions (one week apart). RT was increased and SSRT became shorter from pre-stimulation to post-stimulation testing, indicating within-session learning. Furthermore, compared to the first week of testing, RT was increased and SSRT became shorter in the second week, indicating across-session learning. Within-session learning was significantly higher if anodal stimulation was given in the first week rather than the second week indicating that the behavioural effects of tDCS were dependent on the level of learning. Our findings indicate that tDCS effects on executive functions are dependent on the level of experience (learning) in the cognitive task.",2019,"RT was increased and SSRT became shorter from pre-stimulation to post-stimulation testing, indicating within-session learning.",['73 participants completed the Stop Task before and after tDCS over the dorsolateral prefrontal cortex'],"['task-related learning and transcranial direct current stimulation', 'transcranial direct-current stimulation (tDCS', 'anodal or sham stimulation']","['response time (RT) in Go trials, and stop signal reaction time (SSRT) as an index of inhibition ability', 'anodal stimulation', 'executive functions']","[{'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0450446', 'cui_str': 'Stops (attribute)'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C4019080', 'cui_str': 'Dorsolateral Prefrontal Cortex'}]","[{'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}]","[{'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0450446', 'cui_str': 'Stops (attribute)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}]",73.0,0.0183918,"RT was increased and SSRT became shorter from pre-stimulation to post-stimulation testing, indicating within-session learning.","[{'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Fehring', 'Affiliation': 'Cognitive Neuroscience Laboratory, Department of Physiology, Monash Biomedicine Discovery Institute, Monash University, Victoria, 3800, Australia; ARC Centre of Excellence for Integrative Brain Function, Monash University, Australia.'}, {'ForeName': 'Rosin', 'Initials': 'R', 'LastName': 'Illipparampil', 'Affiliation': 'Cognitive Neuroscience Laboratory, Department of Physiology, Monash Biomedicine Discovery Institute, Monash University, Victoria, 3800, Australia.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Acevedo', 'Affiliation': 'Cognitive Neuroscience Laboratory, Department of Physiology, Monash Biomedicine Discovery Institute, Monash University, Victoria, 3800, Australia.'}, {'ForeName': 'Shapour', 'Initials': 'S', 'LastName': 'Jaberzadeh', 'Affiliation': 'Department of Physiotherapy, Non-invasive Brain Stimulation & Neuroplasticity Laboratory, Monash University, Victoria, 3199, Australia.'}, {'ForeName': 'Paul B', 'Initials': 'PB', 'LastName': 'Fitzgerald', 'Affiliation': 'Epworth Healthcare, The Epworth Clinic, Camberwell, Victoria, 3004, Australia; Monash Alfred Psychiatry Research Centre, Central Clinical School, Monash University and the Alfred Hospital, Victoria, Australia.'}, {'ForeName': 'Farshad A', 'Initials': 'FA', 'LastName': 'Mansouri', 'Affiliation': 'Cognitive Neuroscience Laboratory, Department of Physiology, Monash Biomedicine Discovery Institute, Monash University, Victoria, 3800, Australia; ARC Centre of Excellence for Integrative Brain Function, Monash University, Australia. Electronic address: farshad.mansouri@monash.edu.'}]",Neuropsychologia,['10.1016/j.neuropsychologia.2019.05.011'] 1037,31093987,Effect of counseling based on the choice theory on irrational parenthood cognition and marital quality in infertile women: A randomized controlled trial.,"PURPOSE This study evaluated the effect of counseling based on the choice theory on irrational parenthood cognition (IPC)- and marital quality in infertile women. DESIGN AND METHODS This randomized controlled trial was conducted on 50 primary infertile women in Zanjan, Iran. Stratified block randomization was used to allocate participants to groups. The intervention group received counseling, but the control group received routine care. Data were collected using the IPC and marital relationships quality based on the Glasser's choice theory. FINDINGS A statistically significant difference was found between the groups in IPC (P = 0.005), but the difference in marital quality was not statically significant ( P = 0.085). PRACTICE IMPLICATIONS Counseling can be used for decreasing IPC, but more interventions are needed to increase marital quality.",2020,"FINDINGS A statistically significant difference was found between the groups in IPC (P = 0.005), but the difference in marital quality was not statically significant ( P = 0.085). ","['50 primary infertile women in Zanjan, Iran', 'infertile women']",['control group received routine care'],"['marital quality', 'irrational parenthood cognition and marital quality', 'irrational parenthood cognition (IPC)- and marital quality']","[{'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0021359', 'cui_str': 'Infertility'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0022065', 'cui_str': 'Islamic Republic of Iran'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}]","[{'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0542058', 'cui_str': 'Irrational'}, {'cui': 'C0337469', 'cui_str': 'Parenthood (observable entity)'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}]",50.0,0.0620119,"FINDINGS A statistically significant difference was found between the groups in IPC (P = 0.005), but the difference in marital quality was not statically significant ( P = 0.085). ","[{'ForeName': 'Arezoo', 'Initials': 'A', 'LastName': 'Safaei Nezhad', 'Affiliation': 'Department of Midwifery, School of Nursing and Midwifery, Zanjan University of Medical Sciences, Zanjan, Iran.'}, {'ForeName': 'Loghman', 'Initials': 'L', 'LastName': 'Ebrahimi', 'Affiliation': 'Department of Psychology, University of Zanjan, Zanjan, Iran.'}, {'ForeName': 'Mohammad M', 'Initials': 'MM', 'LastName': 'Vakili', 'Affiliation': 'Department of Health Education & Health Promotion, School of Public Health, Zanjan University of Medical Sciences, Zanjan, Iran.'}, {'ForeName': 'Roghieh', 'Initials': 'R', 'LastName': 'Kharaghani', 'Affiliation': 'Department of Midwifery, School of Nursing and Midwifery, Zanjan University of Medical Sciences, Zanjan, Iran.'}]",Perspectives in psychiatric care,['10.1111/ppc.12392'] 1038,31352829,Edoxaban Versus Warfarin Stratified by Average Blood Pressure in 19 679 Patients With Atrial Fibrillation and a History of Hypertension in the ENGAGE AF-TIMI 48 Trial.,"Hypertension is a risk factor for both stroke and bleeding in patients with atrial fibrillation. Data are sparse regarding the interaction between blood pressure and the efficacy and safety of direct oral anticoagulants. In the ENGAGE AF-TIMI 48 trial (Effective Anticoagulation With Factor Xa Next Generation in Atrial Fibrillation-Thrombolysis in Myocardial Infarction 48), 19,679 patients with atrial fibrillation and hypertension were categorized according to average systolic blood pressure (SBP) and diastolic blood pressure (DBP). The primary efficacy and safety end points were the time to the first stroke or systemic embolic event and the time to the first International Society of Thrombosis and Hemostasis major bleeding event, respectively. Risk was calculated using Cox proportional hazards models based on average SBP and DBP and adjusting for 18 clinical characteristics. The efficacy and safety of a higher dose edoxaban regimen (60/30 mg) versus warfarin were evaluated with stratification by average SBP and DBP. Stroke/systemic embolic event occurred significantly more frequently in patients with elevated average SBP (hazard ratio, 2.01; 95% CI, 1.50-2.70 for SBP ≥150 mm Hg relative to 130-139 mm Hg) or DBP (hazard ratio, 2.36; 95% CI, 1.76-3.16 for DBP ≥90 mm Hg relative to 75-<85 mm Hg). The higher dose edoxaban regimen reduced stroke/systemic embolic event across the full range of SBP (P interaction =0.55) and DBP (P interaction =0.44) compared with warfarin. The higher dose edoxaban regimen reduced the risk of major bleeding events, including intracranial hemorrhage, without modification by average SBP (P interaction =0.29). The relative safety of edoxaban was most pronounced in patients with elevated DBP (P interaction =0.007). The efficacy and safety of edoxaban were consistent across the full range of SBP, while the superior safety of edoxaban was most pronounced among patients with elevated DBP.",2019,"Stroke/systemic embolic event occurred significantly more frequently in patients with elevated average SBP (hazard ratio, 2.01; 95% CI, 1.50-2.70 for SBP ≥150 mm Hg relative to 130-139 mm Hg) or DBP (hazard ratio, 2.36; 95% CI, 1.76-3.16 for DBP ≥90 mm Hg relative to 75-<85 mm Hg).","['19,679 patients with atrial fibrillation and hypertension', 'patients with elevated DBP', '19 679 Patients With Atrial Fibrillation and a History of Hypertension in the ENGAGE AF-TIMI 48 Trial', 'patients with atrial fibrillation']","['warfarin', 'Factor', 'Edoxaban Versus Warfarin', 'edoxaban']","['risk of major bleeding events, including intracranial hemorrhage', 'average systolic blood pressure (SBP) and diastolic blood pressure (DBP', 'efficacy and safety', 'time to the first stroke or systemic embolic event and the time to the first International Society of Thrombosis and Hemostasis major bleeding event, respectively', 'stroke/systemic embolic event', 'Stroke/systemic embolic event', 'DBP']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0455527', 'cui_str': 'H/O: hypertension'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married (finding)'}]","[{'cui': 'C0043031', 'cui_str': 'Warfarin'}, {'cui': 'C2975435', 'cui_str': 'edoxaban'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0151699', 'cui_str': 'Intracranial Hemorrhage'}, {'cui': 'C1282151', 'cui_str': 'Average systolic blood pressure'}, {'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0040053', 'cui_str': 'Thrombosis'}, {'cui': 'C0740166', 'cui_str': 'Haemostasis'}]",,0.0506953,"Stroke/systemic embolic event occurred significantly more frequently in patients with elevated average SBP (hazard ratio, 2.01; 95% CI, 1.50-2.70 for SBP ≥150 mm Hg relative to 130-139 mm Hg) or DBP (hazard ratio, 2.36; 95% CI, 1.76-3.16 for DBP ≥90 mm Hg relative to 75-<85 mm Hg).","[{'ForeName': 'Sungha', 'Initials': 'S', 'LastName': 'Park', 'Affiliation': 'From the Division of Cardiology, Cardiovascular Hospital, Yonsei Health System, Seoul, South Korea (S.P., N.C.).'}, {'ForeName': 'Brian A', 'Initials': 'BA', 'LastName': 'Bergmark', 'Affiliation': ""Thrombolysis in Myocardial Infarction Study Group, Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston, MA (B.A.B., C.T.R., E.M.A., E.B., R.P.G.).""}, {'ForeName': 'Minggao', 'Initials': 'M', 'LastName': 'Shi', 'Affiliation': 'Daiichi Sankyo, Inc., Basking Ridge, NJ (M.S.).'}, {'ForeName': 'Hans-Joachim', 'Initials': 'HJ', 'LastName': 'Lanz', 'Affiliation': 'Daiichi Sankyo Europe GmbH, Munich, Germany (H.J.L.).'}, {'ForeName': 'Namsik', 'Initials': 'N', 'LastName': 'Chung', 'Affiliation': 'From the Division of Cardiology, Cardiovascular Hospital, Yonsei Health System, Seoul, South Korea (S.P., N.C.).'}, {'ForeName': 'Christian T', 'Initials': 'CT', 'LastName': 'Ruff', 'Affiliation': ""Thrombolysis in Myocardial Infarction Study Group, Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston, MA (B.A.B., C.T.R., E.M.A., E.B., R.P.G.).""}, {'ForeName': 'Elliott M', 'Initials': 'EM', 'LastName': 'Antman', 'Affiliation': ""Thrombolysis in Myocardial Infarction Study Group, Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston, MA (B.A.B., C.T.R., E.M.A., E.B., R.P.G.).""}, {'ForeName': 'Eugene', 'Initials': 'E', 'LastName': 'Braunwald', 'Affiliation': ""Thrombolysis in Myocardial Infarction Study Group, Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston, MA (B.A.B., C.T.R., E.M.A., E.B., R.P.G.).""}, {'ForeName': 'Robert P', 'Initials': 'RP', 'LastName': 'Giugliano', 'Affiliation': ""Thrombolysis in Myocardial Infarction Study Group, Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston, MA (B.A.B., C.T.R., E.M.A., E.B., R.P.G.).""}]","Hypertension (Dallas, Tex. : 1979)",['10.1161/HYPERTENSIONAHA.119.13138'] 1039,31154664,Maternal Serum Lipid Trajectories and Association with Pregnancy Loss and Length of Gestation.,"OBJECTIVE We characterized lipid trajectories and investigated lipids and rate of pregnancy lipid change with the risk of pregnancy loss or preterm delivery <37 weeks. STUDY DESIGN In a secondary analysis of 337 women with one to two prior losses assigned to placebo in a randomized controlled trial at four centers (2007-2012), cholesterol, low- and high-density lipoprotein cholesterol (HDL-C), and triglycerides were measured up to 6 months prepregnancy (time 0) and pregnancy up to 7 visits. Trajectories were created using linear mixed models. Multivariable logistic regression with adjustment for maternal characteristics and cholesterol was performed. RESULTS Lipids decreased from prepregnancy to 4 to 5 weeks, followed by an increase, and were biphasic or triphasic depending on the lipid component. Between 4 and 8 weeks, for every 1-unit increase in HDL-C, there was a 22% decreased odds of loss <14 weeks (odds ratio: 0.78; 95% confidence interval: 0.60, 0.99) and 24% decreased odds of loss or preterm delivery 14 to <37 weeks (odds ratio: 0.76; 95% confidence interval: 0.60, 0.96). CONCLUSION There were no associations with other lipid components or other time points. An impaired rise of HDL-C early in pregnancy may signal maladaptation to pregnancy that is associated with pregnancy loss or preterm delivery.",2020,There were no associations with other lipid components or other time points.,['337 women with one to two prior losses assigned to'],['placebo'],"['HDL-C', 'Maternal Serum Lipid Trajectories and Association with Pregnancy Loss and Length of Gestation', 'cholesterol, low- and high-density lipoprotein cholesterol (HDL-C), and triglycerides']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement (procedure)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0687675', 'cui_str': 'Pregnancy loss'}, {'cui': 'C0017504', 'cui_str': 'Fetal Maturity, Chronologic'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0023822', 'cui_str': 'High Density Lipoprotein Cholesterol'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}]",337.0,0.217667,There were no associations with other lipid components or other time points.,"[{'ForeName': 'Katherine L', 'Initials': 'KL', 'LastName': 'Grantz', 'Affiliation': 'Epidemiology Branch, Division of Intramural Population Health Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Angelo', 'Initials': 'A', 'LastName': 'Elmi', 'Affiliation': 'Biostatistics and Bioinformatics Branch, Division of Intramural Population Health Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Sarah J', 'Initials': 'SJ', 'LastName': 'Pugh', 'Affiliation': 'Epidemiology Branch, Division of Intramural Population Health Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Catov', 'Affiliation': 'Department of Obstetrics, Gynecology and Reproductive Science and Department of Epidemiology, Magee-Womens Research Institute, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Lindsey', 'Initials': 'L', 'LastName': 'Sjaarda', 'Affiliation': 'Epidemiology Branch, Division of Intramural Population Health Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Paul S', 'Initials': 'PS', 'LastName': 'Albert', 'Affiliation': 'Biostatistics and Bioinformatics Branch, Division of Intramural Population Health Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, Maryland.'}]",American journal of perinatology,['10.1055/s-0039-1689000'] 1040,31751758,Optimizing Value in the Evaluation of Chronic Spontaneous Urticaria: A Cost-Effectiveness Analysis.,"BACKGROUND Chronic spontaneous urticaria (CSU) affects approximately 1% of the general population. The cost-effectiveness of routine laboratory testing for secondary causes of CSU has not been formally evaluated. OBJECTIVE To characterize the cost-effectiveness of routine laboratory screening in adults with CSU. METHODS A Markov model using cohort analysis and microsimulations was created for adult patients aged 20 years, over a 10-year time horizon, randomized to receive screening laboratory testing or a no-testing approach. Laboratory results were derived from a previously published retrospective analysis of adult patients with CSU. Cost-effectiveness was evaluated at a willingness to pay threshold of $100,000/quality-adjusted life-year using the incremental cost-effectiveness ratio (ICER) in patients with untreated CSU, and patients treated with antihistamines, cyclosporine, or omalizumab. RESULTS Average laboratory costs per simulated patient with CSU were $573 (standard deviation [SD], $41), with only 0.16% (SD, 3.99%) of tests resulting in improved clinical outcomes. Testing costs per laboratory-associated positive outcome were $358,052 (no therapy), $357,576 (antihistamine therapy), $354,115 (cyclosporine), and $262,121 (omalizumab). Screening tests were not cost-effective, with ICERs of $856,905 (no therapy), $855,764 (antihistamine therapy), $847,483 (cyclosporine), and $627,318 (omalizumab). In the omalizumab-treated subgroup, testing could be cost-effective below $220 or if it resulted in a 0.73% rate of CSU resolution. From a simulated US population perspective, nation-wide screening costs could reach $941,750,741 to $1,833,501,483. CONCLUSIONS In CSU, the likelihood of clinical improvement from laboratory testing is very low, and testing is not cost-effective. These data support recommendations to not routinely perform laboratory testing in patients with CSU with otherwise normal histories and physical evaluations.",2020,"Screening tests were not cost-effective, with ICERs of $856,905 (no therapy), $855,764 (anti-histamine therapy), $847,483 (cyclosporine), and $627,318 (omalizumab).","['adult patients aged 20 years', 'Chronic Spontaneous Urticaria', 'adults with CSU', 'CSU patients with otherwise normal histories and physical evaluations']","['routine laboratory screening', 'screening laboratory testing or a no-testing approach', 'cyclosporine, or omalizumab']","['incremental cost-effectiveness ratio (ICER', 'Cost-effectiveness']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0578870', 'cui_str': 'Chronic idiopathic urticaria (disorder)'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0019665', 'cui_str': 'historical aspects'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]","[{'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0010594', 'cui_str': 'Cyclosporins'}, {'cui': 'C0966225', 'cui_str': 'omalizumab'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",,0.0998448,"Screening tests were not cost-effective, with ICERs of $856,905 (no therapy), $855,764 (anti-histamine therapy), $847,483 (cyclosporine), and $627,318 (omalizumab).","[{'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Shaker', 'Affiliation': 'Section of Allergy and Immunology, Dartmouth-Hitchcock Medical Center, Lebanon, NH; Department of Pediatrics, Geisel School of Medicine at Dartmouth, Hanover, NH; Department of Community and Family Medicine, Geisel School of Medicine at Dartmouth, Hanover, NH. Electronic address: Marcus.S.Shaker@hitchcock.org.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Oppenheimer', 'Affiliation': 'Department of Internal Medicine, Rutgers New Jersey Medical School, Newark, NJ.'}, {'ForeName': 'Dana', 'Initials': 'D', 'LastName': 'Wallace', 'Affiliation': 'Department of Medicine, Nova Southeastern Allopathic Medical School, Fort Lauderdale, Fla.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Lang', 'Affiliation': 'Department of Allergy and Clinical Immunology, Respiratory Institute, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Todd', 'Initials': 'T', 'LastName': 'Rambasek', 'Affiliation': 'Division of Allergy and Immunology, Ohio University Heritage College of Osteopathic Medicine, Sandusky, Ohio.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Dykewicz', 'Affiliation': 'Department of Internal Medicine, Section of Allergy and Immunology, Saint Louis University School of Medicine, St. Louis, Mo.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Greenhawt', 'Affiliation': ""Section of Allergy and Immunology, Food Challenge and Research Unit, Children's Hospital Colorado, University of Colorado School of Medicine, Aurora, Colo.""}]",The journal of allergy and clinical immunology. In practice,['10.1016/j.jaip.2019.11.004'] 1041,31124381,Effect of Cholecalciferol Supplementation on Treatment Response and IL-10 Level in Vitamin D Deficient Parthenium Dermatitis Patients: A Randomized Double-Blind Placebo-Controlled Trial.,"Allergic contact dermatitis following exposure to Parthenium is a chronic disease associated with frequent relapses and significant disturbance in the quality of life. The affected patients have lower circulating levels and decreased expression of IL-10. Hence, measures to increase its level may enhance the therapeutic outcome. The clinical trial was undertaken to evaluate the effect of cholecalciferol supplementation on treatment response and IL-10 level in Parthenium dermatitis patients with vitamin D deficiency. A total of 72 patients were recruited and randomized to receive either cholecalciferol tablet 60,000 IU per week or matching placebo for 8 weeks with standard background treatment. Eczema Area Severity Index (EASI) and Dermatology Life Quality Index (DLQI) were assessed at baseline, 4 weeks, and 8 weeks while IL-10 and serum 25-hydroxyvitamin D levels were measured at baseline and 8 weeks. Levels of 25-hydroxyvitamin D and IL-10 showed a significant rise in both placebo and vitamin D groups following the intervention. The relatively higher increase in IL-10 level observed in the vitamin D group was statistically insignificant compared to placebo group. Significant reduction in EASI, as well as DLQI scores, was noted after 1 and 2 months, but the reduction in these scales was not significantly different between the groups. Cholecalciferol supplementation for 2 months did not reduce the disease severity in clinically diagnosed Parthenium dermatitis patients. However, treatment initiation significantly improved plasma IL-10 levels after 2 months in both placebo and cholecalciferol groups.",2020,"However, treatment initiation significantly improved plasma IL-10 levels after 2 months in both placebo and cholecalciferol groups.","['A total of 72 patients', 'Vitamin D Deficient Parthenium Dermatitis Patients', 'Parthenium dermatitis patients with vitamin D deficiency', 'clinically diagnosed Parthenium dermatitis patients']","['Cholecalciferol supplementation', 'placebo', 'Placebo', 'cholecalciferol supplementation', 'cholecalciferol tablet 60,000\u2009IU per week or matching placebo', 'cholecalciferol', 'Cholecalciferol Supplementation']","['Treatment Response and IL-10 Level', 'IL-10 and serum 25-hydroxyvitamin D levels', 'IL-10 level', 'DLQI scores', 'Eczema Area Severity Index (EASI) and Dermatology Life Quality Index (DLQI', 'disease severity', 'plasma IL-10 levels', 'Levels of 25-hydroxyvitamin D and IL-10', 'treatment response and IL-10 level', 'EASI', 'expression of IL-10']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0011155', 'cui_str': 'Deficient (qualifier value)'}, {'cui': 'C0011603', 'cui_str': 'Dermatitis'}, {'cui': 'C0042870', 'cui_str': 'Vitamin D Deficiency'}]","[{'cui': 'C0242215', 'cui_str': 'Cholecalciferols'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0535968', 'cui_str': '25-hydroxyvitamin D'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0013595', 'cui_str': 'Dermatitis, Eczematous'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0451112', 'cui_str': 'Dermatology life quality index (assessment scale)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C3854321', 'cui_str': 'Expression'}]",72.0,0.588655,"However, treatment initiation significantly improved plasma IL-10 levels after 2 months in both placebo and cholecalciferol groups.","[{'ForeName': 'Alphienes', 'Initials': 'A', 'LastName': 'Stanley Xavier', 'Affiliation': 'Department of Pharmacology, Sri Ramachandra Institute of Higher Education and Research, Porur, Chennai, India.'}, {'ForeName': 'Sandhiya', 'Initials': 'S', 'LastName': 'Selvarajan', 'Affiliation': 'Department of Clinical Pharmacology, JIPMER, Puducherry, India.'}, {'ForeName': 'Laxmisha', 'Initials': 'L', 'LastName': 'Chandrasekar', 'Affiliation': 'Department of Dermatology, JIPMER, Puducherry, India.'}, {'ForeName': 'Sadishkumar', 'Initials': 'S', 'LastName': 'Kamalanathan', 'Affiliation': 'Department of Endocrinology, JIPMER, Puducherry, India.'}]",Journal of dietary supplements,['10.1080/19390211.2019.1619009'] 1042,31298652,Effects of Short-Term Fasting and Different Overfeeding Diets on Thyroid Hormones in Healthy Humans.,"Background: A greater decrease in 24-hour energy expenditure (EE) during fasting and a smaller increase in 24-hour EE during low-protein overfeeding (metabolic ""thrifty"" phenotype) predict weight gain. As thyroid hormones (TH) are implicated in energy intake and metabolism, we assessed whether: (i) TH concentrations are altered by 24-hour fasting or overfeeding diets with varying protein content and (ii) diet-related changes in TH correlate with concomitant changes in EE. Methods: Fifty-eight euthyroid healthy subjects with normal glucose regulation underwent 24-hour dietary interventions including fasting, eucaloric feeding, and five overfeeding diets in a crossover design within a whole-room indirect calorimeter to measure the 24-hour EE. Overfeeding diets (200% of energy requirements) included three diets with 20% protein, one diet with 3% protein (low-protein overfeeding diet [LPF]: 46% fat), and one diet with 30% protein (high-protein overfeeding diet [HPF]: 44% fat, n  = 51). Plasma free thyroxine (fT4), free triiodothyronine (fT3), and fibroblast growth factor 21 (FGF21) concentrations were measured after overnight fast the morning of and after each diet. Results: On average, fT4 increased by 8% (+0.10 ng/dL, 95% confidence interval [CI 0.07-0.13], p  < 0.0001) and fT3 decreased by 6% (-0.17 pg/mL [CI -0.27 to -0.07], p  = 0.001) after 24-hour fasting, whereas both fT4 and fT3 decreased by 5% (-0.07 ng/dL [CI -0.11 to -0.04], p  < 0.0001) and 4% (-0.14 pg/mL [CI -0.24 to -0.04], p  = 0.008) following HPF, respectively. Greater decreases in fT3 after HPF are associated with larger decreases in FGF21 ( r  = 0.40, p  = 0.005). Following LPF, the mean fT3 increased by 6% (+0.14 pg/mL [CI 0.05-0.2], p  = 0.003) with no change in fT4 ( p  = 0.7). No changes in TH were observed after normal-protein overfeeding diets (all p  > 0.1). No associations were observed between TH concentrations and diet-related changes in 24-hour EE during any diet (all p  > 0.07). Conclusions: Acute (200%) short-term (24 hours) changes in food intake induce small changes in TH concentrations only after diets with low (0% fasting and 3% protein overfeeding) or high (30% protein overfeeding) protein content. The fT3-FGF21 association after high-protein overfeeding suggests a role for TH in inhibiting FGF21 secretion by the liver during protein excess. These results indicate that TH are involved in protein metabolism; however, they do not mediate the short-term EE response to diets that characterize the metabolic phenotypes and determine the individual susceptibility to weight gain.",2019,"On average, fT4 increased by 8% (+0.10 ng/dL, 95% confidence interval [CI 0.07-0.13], p  < 0.0001) and fT3 decreased by 6% (-0.17 pg/mL","['Healthy Humans', 'Fifty-eight euthyroid healthy subjects with normal glucose regulation underwent']","['diets with 20% protein, one diet with 3% protein (low-protein overfeeding diet [LPF]: 46% fat), and one diet with 30% protein (high-protein overfeeding diet [HPF', 'Short-term Fasting and Different Overfeeding Diets', 'Overfeeding diets', '24-hour dietary interventions including fasting, eucaloric feeding, and five overfeeding diets']","['TH concentrations and diet-related changes in 24-hour EE', 'fT3', 'TH concentrations', '24-hour energy expenditure (EE', 'FGF21', '24-hour EE', 'mean fT3', 'TH', 'Plasma free thyroxine (fT4), free triiodothyronine (fT3), and fibroblast growth factor 21 (FGF21) concentrations', 'food intake']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C4517817', 'cui_str': '58'}, {'cui': 'C0117002', 'cui_str': 'Euthyroid (finding)'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0220905', 'cui_str': 'regulations'}]","[{'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C0560014', 'cui_str': 'ft3'}, {'cui': 'C0014272', 'cui_str': 'Energy Expenditure'}, {'cui': 'C0972232', 'cui_str': 'fibroblast growth factor 21'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0312452', 'cui_str': 'Free thyroxin (substance)'}, {'cui': 'C0370097', 'cui_str': 'Free triiodothyronine (substance)'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}]",,0.0196795,"On average, fT4 increased by 8% (+0.10 ng/dL, 95% confidence interval [CI 0.07-0.13], p  < 0.0001) and fT3 decreased by 6% (-0.17 pg/mL","[{'ForeName': 'Alessio', 'Initials': 'A', 'LastName': 'Basolo', 'Affiliation': 'Obesity and Diabetes Clinical Research Section, Phoenix Epidemiology and Clinical Research Branch, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Phoenix, Arizona.'}, {'ForeName': 'Brittany', 'Initials': 'B', 'LastName': 'Begaye', 'Affiliation': 'Obesity and Diabetes Clinical Research Section, Phoenix Epidemiology and Clinical Research Branch, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Phoenix, Arizona.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Hollstein', 'Affiliation': 'Obesity and Diabetes Clinical Research Section, Phoenix Epidemiology and Clinical Research Branch, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Phoenix, Arizona.'}, {'ForeName': 'Karyne L', 'Initials': 'KL', 'LastName': 'Vinales', 'Affiliation': 'Obesity and Diabetes Clinical Research Section, Phoenix Epidemiology and Clinical Research Branch, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Phoenix, Arizona.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Walter', 'Affiliation': 'Clinical Core Laboratory, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Ferruccio', 'Initials': 'F', 'LastName': 'Santini', 'Affiliation': 'Obesity Research Center, Endocrinology Unit, University Hospital of Pisa, Pisa, Italy.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Krakoff', 'Affiliation': 'Obesity and Diabetes Clinical Research Section, Phoenix Epidemiology and Clinical Research Branch, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Phoenix, Arizona.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Piaggi', 'Affiliation': 'Obesity and Diabetes Clinical Research Section, Phoenix Epidemiology and Clinical Research Branch, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Phoenix, Arizona.'}]",Thyroid : official journal of the American Thyroid Association,['10.1089/thy.2019.0237'] 1043,31912274,"""She is Like a Sister to Me."" Gender-Affirming Services and Relationships are Key to the Implementation of HIV Care Engagement Interventions with Transgender Women of Color.","We present findings from qualitative interviews (N = 67) with 36 staff and 31 participants of nine distinct individual and/or group level interventions to engage transgender women of color (TWOC) in HIV care in the U.S. We examine the commonalities amongst the intervention services (addressing unmet basic needs, facilitating engagement in HIV care, health system navigation, improving health literacy, emotional support), and the relationships formed during implementation of the interventions (between interventionists and participants, among participants in intervention groups, between participants and peers in the community). Interventionists, often TWOC themselves, who provided these services developed caring relationships, promoted personal empowerment, and became role models for participants and the community. Intervention groups engaged participants to reinforce the importance of health and HIV care and provided mutual support. Gender affirming services and caring relationships may be two key characteristics of interventions that address individual and structural-level barriers to engage TWOC in HIV care.",2020,"Interventionists, often TWOC themselves, who provided these services developed caring relationships, promoted personal empowerment, and became role models for participants and the community.",[],['nine distinct individual and/or group level interventions to engage transgender women of color (TWOC) in HIV care in the U.S'],[],[],"[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married (finding)'}, {'cui': 'C1319927', 'cui_str': 'Male-to-female transsexual'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}]",[],,0.045641,"Interventionists, often TWOC themselves, who provided these services developed caring relationships, promoted personal empowerment, and became role models for participants and the community.","[{'ForeName': 'Andres', 'Initials': 'A', 'LastName': 'Maiorana', 'Affiliation': 'Center for AIDS Prevention Studies, University of California San Francisco, 550 16th Street, 3rd floor, Box 0886, San Francisco, CA, 94143, USA. andres.maiorana@ucsf.edu.'}, {'ForeName': 'Jae', 'Initials': 'J', 'LastName': 'Sevelius', 'Affiliation': 'Center for AIDS Prevention Studies and Center of Excellence for Transgender Health, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'JoAnne', 'Initials': 'J', 'LastName': 'Keatley', 'Affiliation': 'Center of Excellence for Transgender Health, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Greg', 'Initials': 'G', 'LastName': 'Rebchook', 'Affiliation': 'Center for AIDS Prevention Studies, University of California San Francisco, 550 16th Street, 3rd floor, Box 0886, San Francisco, CA, 94143, USA.'}]",AIDS and behavior,['10.1007/s10461-020-02777-6'] 1044,31101487,The effect of EDTA-based chelation on patients with diabetes and peripheral artery disease in the Trial to Assess Chelation Therapy (TACT).,"OBJECTIVE Approximately 1 in 7 US adults have diabetes; and over 60% of deaths in patients with diabetes have cardiac disease as a principal or contributing cause. Both coronary and peripheral artery disease (PAD) identify high-risk cohorts among patients with diabetes. We have previously demonstrated improved cardiovascular outcomes with edetate disodium-based chelation in post-MI patients with diabetes, enrolled in the Trial to Assess Chelation Therapy (TACT). In these analyses we further studied the effect size of patients with diabetes and severe disease in 2 vascular beds; coronaries, and lower extremity arteries. We questioned whether greater atherosclerotic burden would attenuate the observed beneficial effect of edetate disodium infusions. RESEARCH DESIGN AND METHODS The multicenter TACT used a double blind, placebo controlled, 2 × 2 factorial design with 1708 participants, randomly assigned to receive edetate disodium-based chelation, or placebo and high dose oral vitamins or placebo. There were 162 (9.5% of 1708) post-MI patients with a diagnosis of diabetes mellitus and PAD for this post hoc analysis. Patients received up to 40 double-blind intravenous infusions of edetate disodium-based chelation, or placebo. The composite primary endpoint of TACT consisted of death from any cause, myocardial infarction, stroke, coronary revascularization and hospitalization for angina. RESULTS The median age was 66 years, 15% female, 5% non-Caucasian, and BMI was 31. Insulin was used by 32% of patients. Active infusions significantly reduced the primary endpoint compared with placebo infusions (HR, 0.52; 95% CI, 0.30-0.92; P = 0.0069), with a 30% absolute risk reduction in the primary endpoint. There was a marked reduction in total mortality from 24% to 11%, although of borderline significance (P = 0.052). CONCLUSION Atherosclerotic disease in multiple vascular beds did not attenuate the beneficial effect of edetate disodium infusions in post MI patients with diabetes. Studies now in progress will prospectively test this post hoc finding.",2019,"Active infusions significantly reduced the primary endpoint compared with placebo infusions (HR, 0.52; 95% CI, 0.30-0.92; P = 0.0069), with a 30% absolute risk reduction in the primary endpoint.","['patients with diabetes', '1708 participants', 'patients with diabetes and peripheral artery disease in the Trial to Assess Chelation Therapy (TACT', 'post MI patients with diabetes', 'The median age was 66\u202fyears, 15% female, 5% non-Caucasian, and BMI was 31', 'patients with diabetes and severe disease in 2 vascular beds; coronaries, and lower extremity arteries', 'post-MI patients with diabetes']","['placebo', 'EDTA-based chelation', 'Chelation Therapy (TACT', 'edetate disodium-based chelation, or placebo and high dose oral vitamins or placebo', 'edetate disodium-based chelation, or placebo', 'disodium-based chelation', 'TACT']","['total mortality', 'cardiovascular outcomes', 'death from any cause, myocardial infarction, stroke, coronary revascularization and hospitalization for angina']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C1704436', 'cui_str': 'Peripheral Artery Disease'}, {'cui': 'C0007975', 'cui_str': 'Chelation Therapy'}, {'cui': 'C0618927', 'cui_str': 'TACT'}, {'cui': 'C0856742', 'cui_str': 'Post MI'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0004916', 'cui_str': 'Beds'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0003842', 'cui_str': 'Arteries'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0529584', 'cui_str': 'isothiocyanatobenzyl-EDTA'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0007975', 'cui_str': 'Chelation Therapy'}, {'cui': 'C0618927', 'cui_str': 'TACT'}, {'cui': 'C0012695', 'cui_str': 'edetate sodium'}, {'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0042890', 'cui_str': 'Vitamins'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0877341', 'cui_str': 'Coronary revascularisation'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0002962', 'cui_str': 'Stenocardia'}]",1708.0,0.508501,"Active infusions significantly reduced the primary endpoint compared with placebo infusions (HR, 0.52; 95% CI, 0.30-0.92; P = 0.0069), with a 30% absolute risk reduction in the primary endpoint.","[{'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Ujueta', 'Affiliation': 'Department of Medicine, Mount Sinai Medical Center, 4300 Alton Road, Miami Beach, FL, USA.'}, {'ForeName': 'Ivan A', 'Initials': 'IA', 'LastName': 'Arenas', 'Affiliation': 'Columbia University Division of Cardiology, Mount Sinai Medical Center, 4300 Alton Road, Miami Beach, FL, USA.'}, {'ForeName': 'Esteban', 'Initials': 'E', 'LastName': 'Escolar', 'Affiliation': 'Columbia University Division of Cardiology, Mount Sinai Medical Center, 4300 Alton Road, Miami Beach, FL, USA.'}, {'ForeName': 'Denisse', 'Initials': 'D', 'LastName': 'Diaz', 'Affiliation': 'Columbia University Division of Cardiology, Mount Sinai Medical Center, 4300 Alton Road, Miami Beach, FL, USA.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Boineau', 'Affiliation': 'National Center of Complementary and Integrative Health (NCCIH), Bethesda, MD, USA.'}, {'ForeName': 'Daniel B', 'Initials': 'DB', 'LastName': 'Mark', 'Affiliation': 'Duke Clinical Research Institute, Durham, NC, USA.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Golden', 'Affiliation': 'The Golden Center for Integrative Medicine, Fresno, CA, USA.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Lindblad', 'Affiliation': 'Duke Clinical Research Institute, Durham, NC, USA.'}, {'ForeName': 'Hwasoon', 'Initials': 'H', 'LastName': 'Kim', 'Affiliation': 'Duke Clinical Research Institute, Durham, NC, USA.'}, {'ForeName': 'Kerry L', 'Initials': 'KL', 'LastName': 'Lee', 'Affiliation': 'Duke Clinical Research Institute, Durham, NC, USA.'}, {'ForeName': 'Gervasio A', 'Initials': 'GA', 'LastName': 'Lamas', 'Affiliation': 'Department of Medicine, Mount Sinai Medical Center, 4300 Alton Road, Miami Beach, FL, USA; Columbia University Division of Cardiology, Mount Sinai Medical Center, 4300 Alton Road, Miami Beach, FL, USA. Electronic address: gervasio.lamas@msmc.com.'}]",Journal of diabetes and its complications,['10.1016/j.jdiacomp.2019.04.005'] 1045,31738574,Effects of Skin-to-Skin Care During Cesareans: A Quasiexperimental Feasibility/Pilot Study.,"Introduction : Our aim was to describe feasibility and outcomes of skin-to-skin care (SSC) that began during cesarean surgery and continued, uninterrupted, for about 5 hours. We described maternal/newborn measures of physiologic stability and stress; maternal measures of comfort; maternal satisfaction with surgery and SSC; and exclusive breast milk feeding at discharge. Materials and Methods: We used a quasiexperimental, time-interrupted design and randomly assigned women to receive SSC that began during surgery (Group 1, intervention; n  = 20) or after surgery, before transfer to recovery (Group 2, standard care; n  = 20). We analyzed differences across time and for five observations: before transfer to the operating room (OR); in the OR, about 20 minutes after birth; in the recovery room, about 1 hour after admission; in the New Family Center (NFC), about 1 hour after admission; and in the NFC, about 2 hours after admission. Results: Group 1 began SSC an average of 0.89 minutes after birth and continued an average of 300 minutes and Group 2 began an average of 46 minutes after birth and continued an average of 126 minutes. Women who began SSC during surgery were more satisfied with the experience ( p  = 0.015) and had lower levels of salivary cortisol across time ( p  = 0.003). We found no negative effects on maternal or newborn measures of physiologic stability and no difference in exclusive breast milk feeding rates at discharge. Conclusion: Immediate and uninterrupted SSC during medically uncomplicated cesarean surgery is a feasible, low-cost intervention that can safely begin during surgery and continue, uninterrupted, for extended durations.",2019,We found no negative effects on maternal or newborn measures of physiologic stability and no difference in exclusive breast milk feeding rates at discharge. ,[],"['skin-to-skin care (SSC', 'Skin-to-Skin Care', 'surgery and SSC']",['salivary cortisol across time'],[],"[{'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0150773', 'cui_str': 'Skin Care'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0442040', 'cui_str': 'Salivary (qualifier value)'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",,0.0388517,We found no negative effects on maternal or newborn measures of physiologic stability and no difference in exclusive breast milk feeding rates at discharge. ,"[{'ForeName': 'Jeannette T', 'Initials': 'JT', 'LastName': 'Crenshaw', 'Affiliation': 'School of Nursing, Texas Tech University Health Sciences Center, Lubbock, Texas.'}, {'ForeName': 'Ellise D', 'Initials': 'ED', 'LastName': 'Adams', 'Affiliation': 'College of Nursing, University of Alabama in Huntsville, Huntsville, Alabama.'}, {'ForeName': 'Richard E', 'Initials': 'RE', 'LastName': 'Gilder', 'Affiliation': 'School of Nursing, Texas Tech University Health Sciences Center, Lubbock, Texas.'}, {'ForeName': 'Kristine', 'Initials': 'K', 'LastName': 'DeButy', 'Affiliation': ""Women and Children's Services, Baylor University Medical Center, Dallas, Texas.""}, {'ForeName': 'Kristin L', 'Initials': 'KL', 'LastName': 'Scheffer', 'Affiliation': ""Perinatal Education, Women and Children's Services, Baylor University Medical Center, Dallas, Texas.""}]",Breastfeeding medicine : the official journal of the Academy of Breastfeeding Medicine,['10.1089/bfm.2019.0202'] 1046,31079146,"Safety Comparison of Two Enterovirus 71 (EV71) Inactivated Vaccines in Yiwu, China.","The safety of two kinds of post-marketing enterovirus 71 (EV71) vaccine in China was evaluated in this study. Fourteen vaccination clinics were randomly assigned in a 1:1 ratio, and both children in two groups were administered according to a two-dose schedule (on a 0 and 28 day schedule). Written informed consent was obtained, and recipients in this study were observed for 30 min after inoculation in the clinic, and then followed via phone or on-site follow-up at day 3 and 30. No severe EV71-associated adverse event was reported. No significant difference was noticed between Group Sinovac and Group CAMS (χz = 0.346, p = 0.556). There was no significant difference in the occurrence of adverse events among recipients aged less than 24 months; however, the proportion of adverse events was higher in Group CAMS than in Group Sinovac among the subjects aged 24-35 months (5.3% vs. 2.5%, p < 0.001). The two kinds of EV71 vaccines showed satisfactory safety. Adverse events after vaccination were normal and acceptable.",2019,"No significant difference was noticed between Group Sinovac and Group CAMS (χz = 0.346, p = 0.556).","['Fourteen vaccination clinics', 'Yiwu, China']",['Two Enterovirus 71 (EV71) Inactivated Vaccines'],"['satisfactory safety', 'proportion of adverse events', 'Adverse events', 'occurrence of adverse events']","[{'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0338051', 'cui_str': 'Vaccination clinic (environment)'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}]","[{'cui': 'C0014383', 'cui_str': 'Enterovirus'}, {'cui': 'C0042212', 'cui_str': 'Vaccines, Killed'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}]",,0.0379054,"No significant difference was noticed between Group Sinovac and Group CAMS (χz = 0.346, p = 0.556).","[{'ForeName': 'Shuying', 'Initials': 'S', 'LastName': 'Luo', 'Affiliation': 'Division of Planned Immunization, Yiwu Center for Disease Prevention and Control, Zhejiang Province, China.'}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Wu', 'Affiliation': 'Division of Planned Immunization, Yiwu Center for Disease Prevention and Control, Zhejiang Province, China.'}, {'ForeName': 'Xiaojun', 'Initials': 'X', 'LastName': 'Ye', 'Affiliation': 'Division of Planned Immunization, Yiwu Center for Disease Prevention and Control, Zhejiang Province, China.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Fu', 'Affiliation': 'Division of Planned Immunization, Yiwu Center for Disease Prevention and Control, Zhejiang Province, China.'}, {'ForeName': 'Jingbo', 'Initials': 'J', 'LastName': 'Tao', 'Affiliation': 'Division of Planned Immunization, Yiwu Center for Disease Prevention and Control, Zhejiang Province, China.'}, {'ForeName': 'Weibiao', 'Initials': 'W', 'LastName': 'Luo', 'Affiliation': 'Division of Planned Immunization, Yiwu Center for Disease Prevention and Control, Zhejiang Province, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Division of Planned Immunization, Yiwu Center for Disease Prevention and Control, Zhejiang Province, China.'}, {'ForeName': 'Jianwei', 'Initials': 'J', 'LastName': 'Jia', 'Affiliation': 'Division of Planned Immunization, Yiwu Center for Disease Prevention and Control, Zhejiang Province, China.'}, {'ForeName': 'Lingqiao', 'Initials': 'L', 'LastName': 'Lou', 'Affiliation': 'Division of Planned Immunization, Yiwu Center for Disease Prevention and Control, Zhejiang Province, China.'}]",Journal of tropical pediatrics,['10.1093/tropej/fmz004'] 1047,7949612,"Consequences of growth hormone deficiency in adults, and effects of growth hormone replacement therapy.",,1994,,[],['growth hormone replacement therapy'],[],[],"[{'cui': 'C0037663', 'cui_str': 'Somatotropin'}, {'cui': 'C0279033', 'cui_str': 'Replacement therapy'}]",[],,0.0189886,,"[{'ForeName': 'T', 'Initials': 'T', 'LastName': 'Rosén', 'Affiliation': 'Department of Medicine, University of Gothenburg, Sweden.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Johannsson', 'Affiliation': ''}, {'ForeName': 'B A', 'Initials': 'BA', 'LastName': 'Bengtsson', 'Affiliation': ''}]","Acta paediatrica (Oslo, Norway : 1992). Supplement",[] 1048,31630445,Weekly adalimumab treatment decreased disease flare in hidradenitis suppurativa over 36 weeks: integrated results from the phase 3 PIONEER trials.,"BACKGROUND Hidradenitis suppurativa (HS) is a chronic skin disease characterized by inflammatory lesions that flare unpredictably. The impact of weekly adalimumab (ADAew) on HS flare is not well-characterized. OBJECTIVE To evaluate the impact of disease flare on health-related quality of life (HRQOL) in moderate-to-severe HS patients and to determine the effect of ADAew on disease flare using integrated data from two phase 3 trials over 36 weeks. METHODS In period A (12 weeks), Dermatology Life Quality Index (DLQI) score change from baseline was compared in patients who flared and those who did not, regardless of treatment. The proportion of patients experiencing flare, duration of flare and time to flare was evaluated for ADAew vs. placebo (PBO). In period B (24 weeks), proportion of patients experiencing flare who received continuous ADAew treatment through 36 weeks was assessed. RESULTS HRQOL was markedly improved among those who did not experience flare. In period A, the proportion of patients who experienced flare was significantly lower with ADAew vs. PBO (12.3% vs. 35.3%, P < 0.001). ADAew patients also had longer time to first flare (101 days vs. 57 days; P < 0.001) and shorter flare duration (18.9 days vs. 32.0 days, respectively; P = 0.001) vs. PBO. Through 36 weeks of treatment, 20.2% of ADAew patients flared, and for those who achieved at least a partial clinical response to ADAew at 12 weeks, only 5.7% flared. CONCLUSIONS Flare reduction is an important measure in HS that correlates with clinically meaningful improvement in HRQOL. ADAew reduces HS flare through 12 and subsequent 36 weeks of treatment.",2020,"ADAew patients also had longer time to first flare (101 days vs. 57 days; P < 0.001) and shorter flare duration (18.9 days vs. 32.0 days, respectively; P = 0.001) vs. PBO.",['moderate-to-severe HS patients'],"['Weekly adalimumab', 'adalimumab (ADAew']","['Dermatology Life Quality Index (DLQI) score change', 'longer time to first flare', 'partial clinical response to ADAew', 'health-related quality of life (HRQOL', 'HRQOL', 'shorter flare duration', 'proportion of patients experiencing flare, duration of flare, and time to flare']","[{'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C1122087', 'cui_str': 'adalimumab'}]","[{'cui': 'C4706308', 'cui_str': 'Dermatology Life Quality Index score'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]",,0.0440113,"ADAew patients also had longer time to first flare (101 days vs. 57 days; P < 0.001) and shorter flare duration (18.9 days vs. 32.0 days, respectively; P = 0.001) vs. PBO.","[{'ForeName': 'H H', 'Initials': 'HH', 'LastName': 'van der Zee', 'Affiliation': 'Department of Dermatology, Erasmus Medical Center, Rotterdam, The Netherlands.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Longcore', 'Affiliation': 'AbbVie Inc, North Chicago, IL, USA.'}, {'ForeName': 'Z', 'Initials': 'Z', 'LastName': 'Geng', 'Affiliation': 'AbbVie Inc, North Chicago, IL, USA.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Garg', 'Affiliation': 'Department of Dermatology, Zucker School of Medicine at Hofstra/Northwell, New Hyde Park, NY, USA.'}]",Journal of the European Academy of Dermatology and Venereology : JEADV,['10.1111/jdv.16023'] 1049,31082829,"Cognitive Effects of Combined Amisulpride and Quetiapine Treatment in Patients With Refractory Schizophrenia: A Naturalistic, Prospective Study.","BACKGROUND Regarding the treatment of patients with resistant schizophrenia, different options exit, although they are supported by limited evidence. In this study, antipsychotic polypharmacy, comprising 1200 mg of amisulpride and 600 mg of quetiapine, was used. Clinical change evaluation was performed using neurocognitive evaluations. STUDY QUESTION The use of amisulpride and quetiapine will imply a clinical improvement in patients affected by schizophrenia, which will be specially reflected in a cognitive improvement. STUDY DESIGN Naturalistic and prospective study. Twenty-six patients were applied and assessed by a battery of neurocognitive evaluations since the pretreatment baseline until 6-month treatment. The patients had no biological response to medication, high social maladjustment, and a long clinical history of the disease. Kane and Brenner criteria for treatment-resistant schizophrenia were applied to choose the subjects. MEASURES AND OUTCOMES The cognitive improvement will imply a significant betterment, from the pretreatment baseline until 6-month treatment, in the following cognitive tests: Stroop Test, WAIS Coding Subtest, and Comprehensive Trail Making Test (CTMT). An improvement in the Calgary Depression Scale, Simpson-Angus Scale, and Visual Analogue Scale (EVA) will also be observed. This scales were been used during the baseline, 3 months after, and then, 6 months. RESULTS Subjects, after 6-month treatment with amisulpride and quetiapine, did show statistically significant differences in the assessed areas: WAIS Coding Subtest (P < 0.001), CTMT A and B (CTMT A P < 0.034; CTMT B P < 0.000), and Stroop Tests: Word (P < 0.001), Word-Color (P < 0.007), and Interference (P < 0.039). Furthermore, they showed a statistically significant difference in the Calgary Depression Scale (P < 0.002), Simpson-Angus Scale (P < 0.019), and EVA (P < 0.001). CONCLUSIONS The results of this report show a cognitive and clinical improvement in refractory patients after the administration of amisulpride and quetiapine.",2020,"Furthermore, they showed a statistically significant difference in the Calgary Depression Scale (P < 0.002), Simpson-Angus Scale (P < 0.019), and EVA (P < 0.001). ","['Patients With Refractory Schizophrenia', 'patients with resistant schizophrenia']","['quetiapine', 'amisulpride and quetiapine', 'amisulpride', 'Combined Amisulpride and Quetiapine']","['Word-Color', 'Simpson-Angus Scale', 'Calgary Depression Scale', 'WAIS Coding Subtest, and Comprehensive Trail Making Test (CTMT', 'Calgary Depression Scale, Simpson-Angus Scale, and Visual Analogue Scale (EVA']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C0332325', 'cui_str': 'Resistant (qualifier value)'}]","[{'cui': 'C0123091', 'cui_str': 'quetiapine'}, {'cui': 'C0103045', 'cui_str': 'Amisulpride'}, {'cui': 'C0336789', 'cui_str': 'Combine'}]","[{'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0222045'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0009219', 'cui_str': 'Coding'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0242686', 'cui_str': 'EVA'}]",26.0,0.0198402,"Furthermore, they showed a statistically significant difference in the Calgary Depression Scale (P < 0.002), Simpson-Angus Scale (P < 0.019), and EVA (P < 0.001). ","[{'ForeName': 'Juan de Dios', 'Initials': 'JD', 'LastName': 'Molina', 'Affiliation': 'Head of Mental Health Center of Villaverde, Service of Psychiatry, Hospital 12 de Octubre ResearchInstitute (i+12), Madrid, Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Quintero', 'Affiliation': 'Head of Psychiatry Service, Hospital Infanta Leonor, Madrid, Spain.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'García-Laredo', 'Affiliation': 'National Distance Education University, UNED, Madrid, Spain.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'López-Muñoz', 'Affiliation': 'Faculty of Health Sciences and Criminology Degree, University Francisco de Vitoria (UFV), Madrid, Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Correas-Lauffer', 'Affiliation': 'Head of Psychiatry Service, Hospital del Henares, Madrid, Spain.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Barbudo', 'Affiliation': 'Psychiatry Service, Hospital Clínico San Carlos, Madrid, Spain.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Ceverino', 'Affiliation': 'Psychiatry Service, Fundación Jimenez Diaz, Madrid, Spain.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Mur', 'Affiliation': 'Hospital Universitario de Fuenlabrada, Madrid, Spain.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Garcia-Resa', 'Affiliation': 'Mental Health Center of Villena, Hospital General Universitario de Elda, Alicante, Spain.'}]",American journal of therapeutics,['10.1097/MJT.0000000000000956'] 1050,31733767,Immediate effects and associations between interoceptive accuracy and range of motion after a HVLA thrust on the thoracolumbar junction: A randomised controlled trial.,"BACKGROUND There is paucity in the literature regarding the role of interoceptive accuracy (IAc) at predicting the effectiveness of osteopathic techniques which increase spinal mobility when directed specifically at the thoracolumbar junction (TLJ). AIMS The study aimed to explore whether a high velocity, low amplitude (HVLA) thrust of the TLJ would increase spinal mobility (measured through Range of Motion; ROM) and change IAc. Also, whether baseline IAc correlated with the post-ROM measures and change in ROM. METHOD 21 asymptomatic participants were allocated into three conditions in a randomised order. These were; (1) a high velocity low amplitude manipulation of the TLJ; (2) sham (basic touch); and (3) a control (laying supine on a plinth). Before and following each intervention, the participants' spinal ROM was measured using an Acumar digital inclinometer. In addition to this an ECG was used to measure their pre and post condition IAc. RESULTS There were significant increases in ROM for all condition, however, the HVLA thrust led to a significantly greater increase in ROM (p < 0.001) when compared to the control and sham. Baseline IAc was inversely associated with post-ROM but there was no association with change in ROM. The HVLA thrust did not significantly change IAc scores from pre to post intervention. CONCLUSIONS HVLA thrust over the TLJ is a useful intervention for increasing spinal ROM. IAc maybe a useful predictor for intervention effectiveness of this technique and spinal area which could in the future be utilised by osteopaths as part of their diagnostics.",2019,"There were significant increases in ROM for all condition, however, the HVLA thrust led to a significantly greater increase in ROM (p < 0.001) when compared to the control and sham.",['21 asymptomatic participants'],"['TLJ', 'HVLA', 'control (laying supine on a plinth']","['Baseline IAc', 'spinal mobility', 'post-ROM measures and change in ROM', 'change IAc scores', 'ROM']","[{'cui': 'C0231221', 'cui_str': 'Asymptomatic (finding)'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",21.0,0.0513126,"There were significant increases in ROM for all condition, however, the HVLA thrust led to a significantly greater increase in ROM (p < 0.001) when compared to the control and sham.","[{'ForeName': 'Ffion Sian', 'Initials': 'FS', 'LastName': 'Griffiths', 'Affiliation': 'Swansea University, Swansea, UK.'}, {'ForeName': 'Terence', 'Initials': 'T', 'LastName': 'McSweeney', 'Affiliation': 'Swansea University, Swansea, UK.'}, {'ForeName': 'Darren J', 'Initials': 'DJ', 'LastName': 'Edwards', 'Affiliation': 'Swansea University, Swansea, UK. Electronic address: D.J.Edwards@swansea.ac.uk.'}]",Journal of bodywork and movement therapies,['10.1016/j.jbmt.2019.06.007'] 1051,31083052,Moderators of Response to Cognitive Behavior Therapy for Major Depression in Patients With Heart Failure.,"OBJECTIVE Although cognitive behavior therapy (CBT) is efficacious for major depression in patients with heart failure (HF), approximately half of patients do not remit after CBT. To identify treatment moderators that may help guide treatment allocation strategies and serve as new treatment targets, we performed a secondary analysis of a randomized clinical trial. Based on evidence of their prognostic relevance, we evaluated whether clinical and activity characteristics moderate the effects of CBT. METHODS Participants were randomized to enhanced usual care (UC) alone or CBT plus enhanced UC. The single-blinded outcomes were 6-month changes in Beck Depression Inventory total scores and remission (defined as a Beck Depression Inventory ≤ 9). Actigraphy was used to assess daily physical activity patterns. We performed analyses to identify the specific activity and clinical moderators of the effects of CBT in 94 adults (mean age = 58, 49% female) with HF and major depressive disorder. RESULTS Patients benefited more from CBT (versus UC) if they had the following: more medically severe HF (i.e., a higher New York Heart Association class or a lower left ventricular ejection fraction), more stable activity patterns, wider active periods, and later evening settling times. These individual moderator effects were small (|r| = 0.10-0.21), but combining the moderators yielded a medium moderator effect size (r = 0.38; 95% CI = 0.20-0.52). CONCLUSIONS These findings suggest that increasing the cross-daily stability of activity patterns, and prolonging the daily active period, might help increase the efficacy of CBT. Given moderating effects of HF severity measures, research is also needed to clarify and address factors in patients with less severe HF that diminish the efficacy of CBT. CLINICAL TRIAL REGISTRATION clinicaltrials.gov identifier: NCT01028625.",2019,"These individual moderator effects were small (|r| = 0.10-0.21), but combining the moderators yielded a medium moderator effect size (r = 0.38; 95% CI = 0.20-0.52). ","['patients with heart failure (HF', 'patients with less severe HF', 'Patients With Heart Failure', '94 adults (mean age = 58, 49% female) with HF and major depressive disorder', 'Participants']","['cognitive behavior therapy (CBT', 'Cognitive Behavior Therapy', 'enhanced usual care (UC) alone or CBT plus enhanced UC', 'CBT']","['daily physical activity patterns', 'Beck Depression Inventory total scores and remission (defined as a Beck Depression Inventory ≤ 9']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory (assessment scale)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}]",,0.103956,"These individual moderator effects were small (|r| = 0.10-0.21), but combining the moderators yielded a medium moderator effect size (r = 0.38; 95% CI = 0.20-0.52). ","[{'ForeName': 'Stephen F', 'Initials': 'SF', 'LastName': 'Smagula', 'Affiliation': 'From the Department of Psychiatry (Smagula, Wallace), School of Medicine, University of Pittsburgh; Department of Epidemiology (Smagula), Graduate School of Public Health, University of Pittsburgh, Pittsburgh, PA; Department of Psychiatry (Freedland, Steinmeyer, R.M. Carney), Washington University School of Medicine; and Division of Cardiology (M.W. Carney), Department of Medicine, Washington University School of Medicine, St. Louis, MO.'}, {'ForeName': 'Kenneth E', 'Initials': 'KE', 'LastName': 'Freedland', 'Affiliation': ''}, {'ForeName': 'Brian C', 'Initials': 'BC', 'LastName': 'Steinmeyer', 'Affiliation': ''}, {'ForeName': 'Meredith J', 'Initials': 'MJ', 'LastName': 'Wallace', 'Affiliation': ''}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Carney', 'Affiliation': ''}, {'ForeName': 'Michael W', 'Initials': 'MW', 'LastName': 'Rich', 'Affiliation': ''}]",Psychosomatic medicine,['10.1097/PSY.0000000000000712'] 1052,31733754,Effects of acupressure on the childbirth satisfaction and experience of birth: A randomized controlled trial.,"BACKGROUND Complementary and alternative medicines have been used to increase comfort and relaxation in mothers during labor. Comforting and preparing the mother in labor can create a positive birth experience. The aim of this study was to evaluate the effect of acupressure on childbirth satisfaction and the experience of giving birth in women with full-term pregnancy, before the onset of labor. METHODS In 2016, a randomized clinical trial study was conducted in Shahid Akbar Abadi Hospital, Tehran, Iran, enrolling 120 pregnant women at 39-40 gestational weeks with no signs of the onset of labor. They were divided randomly into acupressure, sham acupressure, and control groups. Acupressure points including SP6, BL 60, and BL 32 were pressured bilaterally. Interventions were performed by the researcher, the mother and her relative (husband). Childbirth satisfaction was measured 24 h after delivery. The collected data were analyzed by SPSS software and comparing tests were Chi-squared, Kruskal-Wallis, ANOVA tests (P ≤ 0.05). RESULTS The total childbirth satisfaction did not differ significantly among the three groups (P = 0.460), but the acupressure group had a higher level of satisfaction than the other two groups. Moreover, statistical tests regarding the expectations of the childbirth experience showed a significant difference among the groups (P = 0.033). The actual birth was closest to the expectations of subjects in the acupressure group. CONCLUSION This study demonstrated that acupressure may be used as a method in order to attempt to provide a good birth experience and satisfaction of childbirth.",2019,"The total childbirth satisfaction did not differ significantly among the three groups (P = 0.460), but the acupressure group had a higher level of satisfaction than the other two groups.","['Shahid Akbar Abadi Hospital, Tehran, Iran, enrolling 120 pregnant women at 39-40 gestational weeks with no signs of the onset of labor', 'women with full-term pregnancy, before the onset of labor', 'mothers during labor']","['acupressure, sham acupressure', 'acupressure']","['level of satisfaction', 'total childbirth satisfaction', 'Childbirth satisfaction', 'childbirth satisfaction and the experience of giving birth', 'childbirth satisfaction and experience of birth']","[{'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0022065', 'cui_str': 'Islamic Republic of Iran'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0439671', 'cui_str': 'Gestational (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0311392', 'cui_str': 'Sign'}, {'cui': 'C0332162', 'cui_str': 'Onset of (contextual qualifier) (qualifier value)'}, {'cui': 'C0022864', 'cui_str': 'Labor, Obstetric'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0232991', 'cui_str': 'Term pregnancy (finding)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}]","[{'cui': 'C0282614', 'cui_str': 'Acupressure'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1148523', 'cui_str': 'Childbirth'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0005615', 'cui_str': 'Birth'}]",120.0,0.0446122,"The total childbirth satisfaction did not differ significantly among the three groups (P = 0.460), but the acupressure group had a higher level of satisfaction than the other two groups.","[{'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Mahmoudikohani', 'Affiliation': 'School of Nursing and Midwifery, Bam University of Medical Sciences, Bam, Iran.'}, {'ForeName': 'Shahnaz', 'Initials': 'S', 'LastName': 'Torkzahrani', 'Affiliation': 'Department of Midwifery, Faculty of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences, Tehran, Iran. Electronic address: mahmodi2020@yahoo.com.'}, {'ForeName': 'Kiarash', 'Initials': 'K', 'LastName': 'Saatchi', 'Affiliation': 'Acupuncture Medicine Association, Tehran, Iran.'}, {'ForeName': 'Maliheh', 'Initials': 'M', 'LastName': 'Nasiri', 'Affiliation': 'Department of Biostatics, Faculty of Paramedic, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}]",Journal of bodywork and movement therapies,['10.1016/j.jbmt.2019.04.002'] 1053,17187801,Pyridoxine (vitamin B6) therapy for premenstrual syndrome.,,2007,,['premenstrual syndrome'],['Pyridoxine (vitamin B6) therapy'],[],"[{'cui': 'C0033046', 'cui_str': 'PMS - Premenstrual syndrome'}]","[{'cui': 'C0034272', 'cui_str': 'pyridoxine'}, {'cui': 'C0087162', 'cui_str': 'Vitamin B6'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]",[],,0.0415387,,"[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Kashanian', 'Affiliation': 'Department of Obstetrics and Gynecology, Akbarabadi Teaching Hospital, Iran University of Medical Sciences, Tehran, Iran. maryamkashanian@yahoo.com'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Mazinani', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Jalalmanesh', 'Affiliation': ''}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Babayanzad Ahari', 'Affiliation': ''}]",International journal of gynaecology and obstetrics: the official organ of the International Federation of Gynaecology and Obstetrics,[] 1054,31078475,Financial Incentives to Increase Cardiac Rehabilitation Participation Among Low-Socioeconomic Status Patients: A Randomized Clinical Trial.,"OBJECTIVES This study sought to examine the efficacy of financial incentives to increase Medicaid patient participation in and completion of cardiac rehabilitation (CR). BACKGROUND Participation in CR reduces morbidity, mortality, and hospitalizations while improving quality of life. Lower-socioeconomic status (SES) patients are much less likely to attend and complete CR, despite being at increased risk for recurrent cardiovascular events. METHODS A total of 130 individuals enrolled in Medicaid with a CR-qualifying cardiac event were randomized 1:1 to receive financial incentives on an escalating schedule ($4 to $50) for completing CR sessions or to receive usual care. Primary outcomes were CR participation (number of sessions completed) and completion (≥30 sessions completed). Secondary outcomes included changes in sociocognitive measurements (depressive/anxious symptoms, executive function), body composition (waist circumference, body mass index), fitness (peak VO 2 ) over 4 months, and combined number of hospitalizations and emergency department (ED) contacts over 1 year. RESULTS Patients randomized to the incentive condition completed more sessions (22.4 vs. 14.7, respectively; p = 0.013) and were almost twice as likely to complete CR (55.4% vs. 29.2%, respectively; p = 0.002) as controls. Incentivized patients were also more likely to experience improvements in executive function (p < 0.001), although there were no significant effects on other secondary outcomes. Patients who completed ≥30 sessions had 47% fewer combined hospitalizations and ED visits (p = 0.014), as reflected by a nonsignificant trend by study condition with 39% fewer hospital contacts in the incentive condition group (p = 0.079). CONCLUSIONS Financial incentives improve CR participation among lower-SES patients following a cardiac event. Increasing participation among lower-SES patients in CR is critical for positive longer-term health outcomes. (Increasing Cardiac Rehabilitation Participation Among Medicaid Enrollees; NCT02172820).",2019,"Patients who completed ≥30 sessions had 47% fewer combined hospitalizations and ED visits (p = 0.014), as reflected by a nonsignificant trend by study condition with 39% fewer hospital contacts in the incentive condition group (p = 0.079). ","['A total of 130 individuals enrolled in Medicaid with a CR-qualifying cardiac event', 'Low-Socioeconomic Status Patients']",['financial incentives on an escalating schedule ($4 to $50) for completing CR sessions or to receive usual care'],"['hospital contacts', 'CR participation', 'morbidity, mortality, and hospitalizations while improving quality of life', 'CR participation (number of sessions completed) and completion', 'executive function', 'combined hospitalizations and ED visits', 'changes in sociocognitive measurements (depressive/anxious symptoms, executive function), body composition (waist circumference, body mass index), fitness (peak VO 2 ) over 4 months, and combined number of hospitalizations and emergency department (ED) contacts over 1 year']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4319552', 'cui_str': '130 (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0025071', 'cui_str': 'Medicaid'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0086996', 'cui_str': 'Socioeconomic Status'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]","[{'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]",130.0,0.103883,"Patients who completed ≥30 sessions had 47% fewer combined hospitalizations and ED visits (p = 0.014), as reflected by a nonsignificant trend by study condition with 39% fewer hospital contacts in the incentive condition group (p = 0.079). ","[{'ForeName': 'Diann E', 'Initials': 'DE', 'LastName': 'Gaalema', 'Affiliation': 'Department of Psychiatry, University of Vermont, Burlington, Vermont; Department of Psychology, University of Vermont, Burlington, Vermont. Electronic address: dgaalema@uvm.edu.'}, {'ForeName': 'Rebecca J', 'Initials': 'RJ', 'LastName': 'Elliott', 'Affiliation': 'Department of Psychiatry, University of Vermont, Burlington, Vermont.'}, {'ForeName': 'Patrick D', 'Initials': 'PD', 'LastName': 'Savage', 'Affiliation': 'Division of Cardiology, University of Vermont Medical Center, Burlington, Vermont.'}, {'ForeName': 'Jason L', 'Initials': 'JL', 'LastName': 'Rengo', 'Affiliation': 'Division of Cardiology, University of Vermont Medical Center, Burlington, Vermont.'}, {'ForeName': 'Alex Y', 'Initials': 'AY', 'LastName': 'Cutler', 'Affiliation': 'Department of Psychiatry, University of Vermont, Burlington, Vermont.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Pericot-Valverde', 'Affiliation': 'Department of Psychiatry, University of Vermont, Burlington, Vermont.'}, {'ForeName': 'Jeffrey S', 'Initials': 'JS', 'LastName': 'Priest', 'Affiliation': 'Department of Medical Biostatistics, University of Vermont, Burlington, Vermont.'}, {'ForeName': 'Donald S', 'Initials': 'DS', 'LastName': 'Shepard', 'Affiliation': 'Heller School for Social Policy and Management, Brandeis University, Waltham, Massachusetts.'}, {'ForeName': 'Stephen T', 'Initials': 'ST', 'LastName': 'Higgins', 'Affiliation': 'Department of Psychiatry, University of Vermont, Burlington, Vermont; Department of Psychology, University of Vermont, Burlington, Vermont.'}, {'ForeName': 'Philip A', 'Initials': 'PA', 'LastName': 'Ades', 'Affiliation': 'Division of Cardiology, University of Vermont Medical Center, Burlington, Vermont.'}]",JACC. Heart failure,['10.1016/j.jchf.2018.12.008'] 1055,31733780,"Traditional physical therapy exercises combined with sensorimotor training: The effects on clinical outcomes for chronic neck pain in a double-blind, randomized controlled trial.","OBJECTIVE This study examined the effects of combining traditional physical therapy exercises with sensorimotor training on joint position sense, pain, muscle endurance, balance and disability in patients with chronic, non-specific neck pain. DESIGN Double-blind, randomized controlled trial. SUBJECTS A total of 53 patients with chronic non-specific neck pain were randomized to either traditional or combined exercise groups. INTERVENTIONS All patients received 12 sessions of supervised intervention 3 times per week. The traditional group performed traditional exercises, and the combined exercise group performed sensorimotor training in addition to traditional exercises. OUTCOME MEASURES Joint position sense, pain, neck flexor muscle endurance test, 10 Meter Walk Test, step test, and the Neck Disability Index. RESULTS The combined exercise group showed significantly greater improvement compared to the traditional group in joint position sense during extension, flexion, right rotation, the 10 m walk test with head turn, and the step test. Pain intensity, muscle endurance, and disability improved in both groups. Additionally, there was a higher degree of effect on muscle endurance in the combined exercise group compared to a moderate effect in the traditional group. CONCLUSIONS A combination of sensorimotor training with traditional physical therapy exercises could be more effective than traditional exercises alone in improving joint position sense, endurance, dynamic balance and walking speed.",2019,"The combined exercise group showed significantly greater improvement compared to the traditional group in joint position sense during extension, flexion, right rotation, the 10 m walk test with head turn, and the step test.","['53 patients with chronic non-specific neck pain', 'patients with chronic, non-specific neck pain']","['traditional exercises, and the combined exercise group performed sensorimotor training in addition to traditional exercises', 'traditional or combined exercise groups', 'Traditional physical therapy exercises combined with sensorimotor training', 'traditional physical therapy exercises with sensorimotor training', 'sensorimotor training with traditional physical therapy exercises']","['joint position sense, pain, muscle endurance, balance and disability', 'Pain intensity, muscle endurance, and disability', 'muscle endurance', 'joint position sense, endurance, dynamic balance and walking speed', 'Joint position sense, pain, neck flexor muscle endurance test, 10 Meter Walk Test, step test, and the Neck Disability Index', 'chronic neck pain', 'joint position sense during extension, flexion, right rotation, the 10\u202fm walk test with head turn']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0205370', 'cui_str': 'Non-specific (qualifier value)'}, {'cui': 'C0007859', 'cui_str': 'Neck Ache'}]","[{'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}]","[{'cui': 'C0423561', 'cui_str': 'Joint position sense, function (observable entity)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0518031', 'cui_str': 'Endurance capacity'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C2009910', 'cui_str': 'Gait Speed'}, {'cui': 'C0027536', 'cui_str': 'Necking (finding)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0475209', 'cui_str': 'm'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0087028', 'cui_str': 'Step Test'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0746815', 'cui_str': 'Chronic neck pain'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C0231452', 'cui_str': 'Flexion, function (observable entity)'}, {'cui': 'C0205090', 'cui_str': 'Right (qualifier value)'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0018670', 'cui_str': 'Head'}, {'cui': 'C0541749', 'cui_str': 'Does turn (finding)'}]",53.0,0.0508636,"The combined exercise group showed significantly greater improvement compared to the traditional group in joint position sense during extension, flexion, right rotation, the 10 m walk test with head turn, and the step test.","[{'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Saadat', 'Affiliation': 'Musculoskeletal Rehabilitation Research Center, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran. Electronic address: maryamsaadat2008@yahoo.com.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Salehi', 'Affiliation': 'Musculoskeletal Rehabilitation Research Center, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran; Rehabilitation Research Center, Department of Rehabilitation Management, School of Rehabilitation Sciences, Iran University of Medical Sciences, Tehran, Iran. Electronic address: salehi.re@iums.ac.ir.'}, {'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Negahban', 'Affiliation': 'Department of Physical Therapy, School of Paramedical Sciences, Mashhad University of Medical Sciences, Mashhad, Iran; Orthopedic Research Center, Mashhad University of Medical Sciences, Mashhad, Iran. Electronic address: honegahban@yahoo.com.'}, {'ForeName': 'Mohammad Jafar', 'Initials': 'MJ', 'LastName': 'Shaterzadeh', 'Affiliation': 'Musculoskeletal Rehabilitation Research Center, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran. Electronic address: shaterzadeh.pt@gmail.com.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Mehravar', 'Affiliation': 'Musculoskeletal Rehabilitation Research Center, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran. Electronic address: mohammad.mehravar@gmail.com.'}, {'ForeName': 'Masumeh', 'Initials': 'M', 'LastName': 'Hessam', 'Affiliation': 'Musculoskeletal Rehabilitation Research Center, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran. Electronic address: pt81@yahoo.com.'}]",Journal of bodywork and movement therapies,['10.1016/j.jbmt.2019.02.016'] 1056,31253234,"Evidence Map: Reporting of Results by Sex or Gender in Randomized, Controlled Trials with Women Veteran Participants (2008 to 2018).","BACKGROUND Higher participation of women in randomized, controlled trials (RCTs) has not led to significantly improved reporting of sex-stratified results. A recent evidence map of research on women veterans revealed that many studies did not report results by sex or gender. This study's objectives were to compare characteristics of RCTs with women veteran participants that did or did not report results by sex or gender and to assess how sex and gender are addressed in research with women veterans. METHODS We extended the prior evidence map with a systematic search for RCTs with women veterans, published between 2008 and 2018. We compared the characteristics of RCTs that reported results by sex or gender with those of RCTs that did not, and reviewed methodology and reporting of sex/gender analyses. RESULTS In addition to 11 studies from the prior evidence map, we assessed 1,820 abstracts for relevance and ultimately included 45 unique RCTs. Five trials included only women and 40 included both men and women (median, 14.3% women). Ten studies reported results by sex or gender. These trials were larger (median study size of n = 343.5 vs. n = 125.5) and included a higher median proportion of women participants (16.8% vs. 11.2%) than studies without sex/gender results. Ten of 11 trials that tested pharmacologic or device interventions did not report results by sex or gender. CONCLUSIONS Reporting of results by sex or gender remains low in veteran research, but may improve with larger studies and increased recruitment of women veterans into trials. Trials of pharmacologic or device interventions may be targets for future reporting requirements. Standardization could improve attention to sex and gender in methodology and reporting.",2019,These trials were larger (median study size of n = 343.5 vs. n = 125.5) and included a higher median proportion of women participants (16.8% vs. 11.2%) than studies without sex/gender results.,"['women veterans, published between 2008 and 2018', 'Five trials included only women and 40 included both men and women (median, 14.3% women', 'women veterans', 'Women Veteran Participants (2008 to 2018']",['pharmacologic or device interventions'],[],"[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]","[{'cui': 'C0205464', 'cui_str': 'Pharmacologic (qualifier value)'}, {'cui': 'C0220819', 'cui_str': 'devices'}]",[],,0.171717,These trials were larger (median study size of n = 343.5 vs. n = 125.5) and included a higher median proportion of women participants (16.8% vs. 11.2%) than studies without sex/gender results.,"[{'ForeName': 'Elisheva R', 'Initials': 'ER', 'LastName': 'Danan', 'Affiliation': 'VA HSR&D Center for Care Delivery and Outcomes Research, Minneapolis VA Health Care System, Minneapolis, Minnesota; Department of Medicine, University of Minnesota Medical School, Minneapolis, Minnesota. Electronic address: elizabeth.danan@va.gov.'}, {'ForeName': 'Kristen', 'Initials': 'K', 'LastName': 'Ullman', 'Affiliation': 'VA HSR&D Center for Care Delivery and Outcomes Research, Minneapolis VA Health Care System, Minneapolis, Minnesota.'}, {'ForeName': 'Ruth S', 'Initials': 'RS', 'LastName': 'Klap', 'Affiliation': 'VA HSR&D Center for the Study of Healthcare Innovation, Implementation & Policy, VA Greater Los Angeles Healthcare System, Los Angeles, California.'}, {'ForeName': 'Elizabeth M', 'Initials': 'EM', 'LastName': 'Yano', 'Affiliation': 'VA HSR&D Center for the Study of Healthcare Innovation, Implementation & Policy, VA Greater Los Angeles Healthcare System, Los Angeles, California; Department of Health Policy and Management, UCLA Fielding School of Public Health, Los Angeles, California.'}, {'ForeName': 'Erin E', 'Initials': 'EE', 'LastName': 'Krebs', 'Affiliation': 'VA HSR&D Center for Care Delivery and Outcomes Research, Minneapolis VA Health Care System, Minneapolis, Minnesota; Department of Medicine, University of Minnesota Medical School, Minneapolis, Minnesota.'}]",Women's health issues : official publication of the Jacobs Institute of Women's Health,['10.1016/j.whi.2019.04.011'] 1057,30260488,Dietary Management of Blood Glucose in Medical Critically Ill Overweight and Obese Patients: An Open-Label Randomized Trial.,"BACKGROUND Enteral nutrition (EN) increases hyperglycemia due to high carbohydrate concentrations while providing insufficient protein. The study tested whether an EN formula with very high-protein- and low-carbohydrate-facilitated glucose control delivered higher protein concentrations within a hypocaloric protocol. METHODS This was a multicenter, randomized, open-label clinical trial with parallel design in overweight/obese mechanically ventilated critically ill patients prescribed 1.5 g protein/kg ideal body weight/day. Patients received either an experimental very high-protein (37%) and low-carbohydrate (29%) or control high-protein (25%) and conventional-carbohydrate (45%) EN formula. RESULTS A prespecified interim analysis was performed after enrollment of 105 patients (52 experimental, 53 control). Protein and energy delivery for controls and experimental groups on days 1-5 were 1.2 ± 0.4 and 1.1 ± 0.3 g/kg ideal body weight/day (P = .83), and 18.2 ± 6.0 and 12.5 ± 3.7 kcals/kg ideal body weight/day (P < .0001), respectively. The combined rate of glucose events outside the range of >110 and ≤150 mg/dL were not different (P = .54, primary endpoint); thereby the trial was terminated. The mean blood glucose for the control and the experimental groups were 138 (-SD 108, +SD 177) and 126 (-SD 99, +SD 160) mg/dL (P = .004), respectively. Mean rate of glucose events >150 mg/dL decreased (Δ = -13%, P = .015), whereas that of 80-110 mg/dL increased (Δ = 14%, P = .0007). Insulin administration decreased 10.9% (95% CI, -22% to 0.1%; P = .048) in the experimental group relative to the controls. Glycemic events ≤80 mg/dL and rescue dextrose use were not different (P = .23 and P = .53). CONCLUSIONS A very high-protein and low-carbohydrate EN formula in a hypocaloric protocol reduces hyperglycemic events and insulin requirements while increasing glycemic events between 80-110 mg/dL.",2019,"Mean rate of glucose events >150 mg/dL decreased (Δ = -13%, P = .015), whereas that of 80-110 mg/dL increased (Δ = 14%, P = .0007).","['Medical Critically Ill Overweight and Obese Patients', 'overweight/obese mechanically ventilated critically ill patients prescribed 1.5 g protein/kg ideal body weight/day']","['EN formula with very high-protein- and low-carbohydrate-facilitated glucose control', 'low-carbohydrate (29%) or control high-protein (25%) and conventional-carbohydrate (45%) EN formula', 'dL', 'Dietary Management of Blood Glucose', 'Enteral nutrition (EN']","['Protein and energy delivery', 'glycemic events', 'mean blood glucose', 'Mean rate of glucose events', 'hyperglycemic events and insulin requirements']","[{'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0010340', 'cui_str': 'Critically Ill'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0530867', 'cui_str': 'G13 Protein'}, {'cui': 'C0421272', 'cui_str': 'Normal Body Weight'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]","[{'cui': 'C0442804', 'cui_str': 'Very high (qualifier value)'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0012160', 'cui_str': 'nutritional management'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C0086225', 'cui_str': 'Enteral Feeding'}]","[{'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}]",,0.0304656,"Mean rate of glucose events >150 mg/dL decreased (Δ = -13%, P = .015), whereas that of 80-110 mg/dL increased (Δ = 14%, P = .0007).","[{'ForeName': 'Todd W', 'Initials': 'TW', 'LastName': 'Rice', 'Affiliation': 'Division of Allergy, Pulmonary, and Critical Care Medicine, Department of Medicine, Vanderbilt University Medical Center, Nashville, Tennessee, USA.'}, {'ForeName': 'D Clark', 'Initials': 'DC', 'LastName': 'Files', 'Affiliation': 'Department of Internal Medicine-Pulmonary, Critical Care, Allergy and Immunologic Diseases, Wake Forest School of Medicine, Winston-Salem, North Carolina, USA.'}, {'ForeName': 'Peter E', 'Initials': 'PE', 'LastName': 'Morris', 'Affiliation': 'University of Kentucky Healthcare, Lexington, Kentucky, USA.'}, {'ForeName': 'Andrew C', 'Initials': 'AC', 'LastName': 'Bernard', 'Affiliation': 'University of Kentucky Healthcare, Lexington, Kentucky, USA.'}, {'ForeName': 'Thomas R', 'Initials': 'TR', 'LastName': 'Ziegler', 'Affiliation': 'Division of Endocrinology, Metabolism and Lipids, Emory University, Atlanta, Georgia, USA.'}, {'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'Drover', 'Affiliation': ""Department of Critical Care Medicine, Queen's University and Kingston Health Science Center, Kingston, Ontario, Canada.""}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Kress', 'Affiliation': 'The University of Chicago Medicine, Chicago, Illinois, USA.'}, {'ForeName': 'Kealy R', 'Initials': 'KR', 'LastName': 'Ham', 'Affiliation': 'Department of Critical Care Medicine, Regions Hospital, University of Minnesota, St. Paul, Minnesota, USA.'}, {'ForeName': 'Dominik J', 'Initials': 'DJ', 'LastName': 'Grathwohl', 'Affiliation': 'Nestlé Research Center, Vers-chez-les-Blanc, Lausanne, Switzerland.'}, {'ForeName': 'Maureen B', 'Initials': 'MB', 'LastName': 'Huhmann', 'Affiliation': 'Nestlé Health Science, Bridgewater, New Jersey, USA.'}, {'ForeName': 'Juan B Ochoa', 'Initials': 'JBO', 'LastName': 'Gautier', 'Affiliation': 'Nestlé Health Science, Bridgewater, New Jersey, USA.'}]",JPEN. Journal of parenteral and enteral nutrition,['10.1002/jpen.1447'] 1058,31733783,Comparison of two mobilization techniques in management of chronic non-specific low back pain.,"AIM The aim of the study was to compare between the effects of Maitland's postero-anterior (PA glide) mobilization and Mulligan's sustained natural apophyseal glide (SNAG) on pain, mobility, muscle activation and functional disability in subjects with chronic, non-specific low back pain. METHODS The study was a two arm repeated measure design with random allocation of subjects (n = 33). Subjects in group 1 received Maitland's PA glide mobilization and those in group 2 received Mulligan's SNAG. Along with the respective mobilization technique, individualized exercises were common for subjects in both the groups. Subjects in both groups received treatment for 4 days a week for 4 weeks. The outcome measures were numeric pain rating scale (NPRS) scores, lumbar flexion and extension range of motion, erector spinae muscle activity and Oswestry low back pain disability questionnaire score. RESULTS The outcome measure scores showed statistical significance in time effect on NPRS (p = 0.001); lumbar flexion and extension range of motion (p = 0.001); erector spinae muscle activity (0.001); Oswestry low back pain disability questionnaire score (p = 0.001); group effect on lumbar flexion (p = 0.03) and extension range of motion (p = 0.05); and interaction effect (time x group) on lumbar flexion (p = 0.003) and extension range of motion (p = 0.002); and, erector spinae muscle activity (p = 0.05) at the 3rd lumbar vertebral level. CONCLUSION The addition of Maitland or Mulligan mobilization techniques of the spine does not show a difference in the improvement of symptoms associated with chronic non-specific low back pain.",2019,The addition of Maitland or Mulligan mobilization techniques of the spine does not show a difference in the improvement of symptoms associated with chronic non-specific low back pain.,"['subjects with chronic, non-specific low back pain', 'chronic non-specific low back pain', 'subjects (n\u202f=\u202f33']","[""Mulligan's SNAG"", ""Maitland's postero-anterior (PA glide) mobilization and Mulligan's sustained natural apophyseal glide (SNAG"", ""Maitland's PA glide mobilization""]","['lumbar flexion', 'time effect on NPRS', 'erector spinae muscle activity', 'erector spinae muscle activity (0.001); Oswestry low back pain disability questionnaire score', 'numeric pain rating scale (NPRS) scores, lumbar flexion and extension range of motion, erector spinae muscle activity and Oswestry low back pain disability questionnaire score', 'extension range of motion', 'lumbar flexion and extension range of motion', 'pain, mobility, muscle activation\xa0and functional disability']","[{'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0205370', 'cui_str': 'Non-specific (qualifier value)'}, {'cui': 'C0024031', 'cui_str': 'Low Back Ache'}]","[{'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C0336966', 'cui_str': 'Gliding'}, {'cui': 'C0300926', 'cui_str': 'mobilization'}, {'cui': 'C0443318', 'cui_str': 'Sustained (qualifier value)'}, {'cui': 'C0205296', 'cui_str': 'Natural (qualifier value)'}]","[{'cui': 'C0024090', 'cui_str': 'Lumbar Region'}, {'cui': 'C0231452', 'cui_str': 'Flexion, function (observable entity)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0224301', 'cui_str': 'Structure of erector spinae muscle'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C4517385', 'cui_str': '0.001 (qualifier value)'}, {'cui': 'C0024031', 'cui_str': 'Low Back Ache'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0222045'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C0080078', 'cui_str': 'Range of Motion'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}]",,0.0515678,The addition of Maitland or Mulligan mobilization techniques of the spine does not show a difference in the improvement of symptoms associated with chronic non-specific low back pain.,"[{'ForeName': 'Md Nasir', 'Initials': 'MN', 'LastName': 'Ali', 'Affiliation': 'Centre for Physiotherapy and Rehabilitation Sciences, Jamia Milllia Islamia, New Delhi, 111025, India.'}, {'ForeName': 'Kritika', 'Initials': 'K', 'LastName': 'Sethi', 'Affiliation': 'Centre for Physiotherapy and Rehabilitation Sciences, Jamia Milllia Islamia, New Delhi, 111025, India.'}, {'ForeName': 'Majumi M', 'Initials': 'MM', 'LastName': 'Noohu', 'Affiliation': 'Centre for Physiotherapy and Rehabilitation Sciences, Jamia Milllia Islamia, New Delhi, 111025, India. Electronic address: mnoohu@jmi.ac.in.'}]",Journal of bodywork and movement therapies,['10.1016/j.jbmt.2019.02.020'] 1059,31733785,Effects of lumbosacral orthosis on dynamical structure of center of pressure fluctuations in patients with non-specific chronic low back pain: A randomized controlled trial.,"BACKGROUND A few clinical trials have examined the effect of treatment interventions on postural control in patients with chronic low back pain, all of which have exclusively evaluated postural stability using traditional linear measures of postural sway. However, postural control improvement cannot be determined by exclusively relying on linear measurements, because these parameters provide no information on underlying motor control mechanisms. OBJECTIVE This study aimed to compare the effect of using lumbosacral orthoses (LSO) together with routine physical therapy, compared to routine physical therapy alone on postural control, using nonlinear analysis techniques. METHODS Forty-four patients with low back pain were randomly allocated to the intervention and control groups. Both groups underwent 8 sessions of physical therapy twice weekly for 4 weeks. The intervention group received LSO in addition to routine physical therapy. Before and after the intervention, non-linear dynamical features of center of pressure fluctuations were assessed during quiet standing at 3 difficulty levels of postural tasks, including eyes open while standing on a rigid surface, eyes closed while standing on a rigid surface, and eyes closed while standing on a foam surface. RESULTS The results of this study showed that a 4-week intervention consisting of LSO and routine physical therapy modalities did not affect the temporal structure of postural sways in patients with low back pain. CONCLUSION Treatment strategies, such as routine physical therapy modalities or LSO, which exclusively focus on the correction of peripheral mechanics, fail to affect the behavior of the postural control system.",2019,"Before and after the intervention, non-linear dynamical features of center of pressure fluctuations were assessed during quiet standing at 3 difficulty levels of postural tasks, including eyes open while standing on a rigid surface, eyes closed while standing on a rigid surface, and eyes closed while standing on a foam surface. ","['patients with low back pain', 'Forty-four patients with low back pain', 'patients with non-specific chronic low back pain', 'patients with chronic low back pain']","['LSO', 'physical therapy', 'LSO in addition to routine physical therapy', 'routine physical therapy alone', 'lumbosacral orthosis', 'quiet standing at 3 difficulty levels of postural tasks, including eyes open while standing on a rigid surface, eyes closed while standing on a rigid surface, and eyes closed while standing on a foam surface', 'lumbosacral orthoses (LSO', 'routine physical therapy']",['temporal structure of postural sways'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0024031', 'cui_str': 'Low Back Ache'}, {'cui': 'C4319568', 'cui_str': '44'}, {'cui': 'C0205370', 'cui_str': 'Non-specific (qualifier value)'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain (finding)'}]","[{'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0450206', 'cui_str': 'Lumbosacral (qualifier value)'}, {'cui': 'C0439654', 'cui_str': 'Quiet (qualifier value)'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205278', 'cui_str': 'Postural (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C3888057', 'cui_str': 'Stand'}, {'cui': 'C0231517', 'cui_str': 'Rigid (qualifier value)'}, {'cui': 'C0205148', 'cui_str': 'Surface (attribute)'}, {'cui': 'C0587267', 'cui_str': 'Closed (qualifier value)'}, {'cui': 'C0991510', 'cui_str': 'Foam (basic dose form)'}, {'cui': 'C0029365', 'cui_str': 'Orthose'}]","[{'cui': 'C0442043', 'cui_str': 'Temporal (qualifier value)'}, {'cui': 'C0205278', 'cui_str': 'Postural (qualifier value)'}]",44.0,0.0337117,"Before and after the intervention, non-linear dynamical features of center of pressure fluctuations were assessed during quiet standing at 3 difficulty levels of postural tasks, including eyes open while standing on a rigid surface, eyes closed while standing on a rigid surface, and eyes closed while standing on a foam surface. ","[{'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Azadinia', 'Affiliation': 'Department of Orthotics and Prosthetics, School of Rehabilitation Sciences, Iran University of Medical Sciences, Tehran, Iran. Electronic address: Azadinia.fatemeh@yahoo.com.'}, {'ForeName': 'Ismail', 'Initials': 'I', 'LastName': 'Ebrahimi-Takamjani', 'Affiliation': 'Department of Physical Therapy, School of Rehabilitation Sciences, Iran University of Medical Sciences, Tehran, Iran. Electronic address: ebrahimitakamjani.e@iums.ac.ir.'}, {'ForeName': 'Mojtaba', 'Initials': 'M', 'LastName': 'Kamyab', 'Affiliation': 'Department of Orthotics and Prosthetics, School of Rehabilitation Sciences, Iran University of Medical Sciences, Tehran, Iran. Electronic address: kamyab.m@iums.ac.ir.'}, {'ForeName': 'Morteza', 'Initials': 'M', 'LastName': 'Asgari', 'Affiliation': 'Department of Mechanical Engineering, Sharif University of Technology, Tehran, Iran. Electronic address: morteza_asgari@alum.sharif.edu.'}, {'ForeName': 'Mohamad', 'Initials': 'M', 'LastName': 'Parnianpour', 'Affiliation': 'Biomechanics Laboratory, Department of Mechanical Engineering, Sharif University of Technology, Tehran, Iran. Electronic address: parnianpour@sharif.edu.'}]",Journal of bodywork and movement therapies,['10.1016/j.jbmt.2019.01.014'] 1060,31733755,Effects of mirthful laughter on pain tolerance: A randomized controlled investigation.,"INTRODUCTION Chronic pain is a debilitating condition that affects many people. Currently, there is no single treatment known to cure or assure relief from chronic pain. Accordingly, the management of patients' discomfort is an integral part of treating chronic pain. Such treatment, however, is not effective for many patients. We investigated whether mirthful laughter provided by comic relief can influence pain tolerance and muscle soreness in young healthy participants. METHODS Forty participants underwent a randomized controlled cross-over designed experiment. Each participant was exposed to a comedy video eliciting mirthful laughter and an uninteresting documentary. Delayed onset muscle soreness was induced in one leg at a time by eccentric exercise. Pain tolerance was tested using blunt force application and assessed subjectively using a visual analog scale. RESULTS Watching the comedy video elicited a significantly greater irregular breathing pattern compared with watching the documentary video (p < 0.001). After watching the comedy, the participants' positive affect was increased (Δ2 ± 1) while it was largely decreased (Δ-11 ± 2) after watching the documentary video (p < 0.001). Pain tolerance was decreased by 17 ± 5 N after viewing the documentary video (p < 0.001), but did not change significantly after watching the comedy. CONCLUSIONS Thirty minutes of watching a comedy eliciting laughter favorably influenced pain tolerance in healthy humans. CLINICAL TRIAL NO.: #NCT02896075.",2019,"Pain tolerance was decreased by 17 ± 5 N after viewing the documentary video (p < 0.001), but did not change significantly after watching the comedy. ","['healthy humans', 'Forty participants', 'young healthy participants']",['mirthful laughter'],"['pain tolerance and muscle soreness', 'pain tolerance', 'Delayed onset muscle soreness', 'Pain tolerance', 'irregular breathing pattern']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0023133', 'cui_str': 'Laughter'}]","[{'cui': 'C0162703', 'cui_str': 'Pain Threshold'}, {'cui': 'C0231528', 'cui_str': 'Muscle Pain'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0425492', 'cui_str': 'Irregular breathing (finding)'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}]",40.0,0.112945,"Pain tolerance was decreased by 17 ± 5 N after viewing the documentary video (p < 0.001), but did not change significantly after watching the comedy. ","[{'ForeName': 'Stephanie S', 'Initials': 'SS', 'LastName': 'Lapierre', 'Affiliation': 'Cardiovascular Aging Research Laboratory, The University of Texas at Austin, Department of Kinesiology and Health Education, Austin, TX, USA.'}, {'ForeName': 'Brett D', 'Initials': 'BD', 'LastName': 'Baker', 'Affiliation': 'Cardiovascular Aging Research Laboratory, The University of Texas at Austin, Department of Kinesiology and Health Education, Austin, TX, USA.'}, {'ForeName': 'Hirofumi', 'Initials': 'H', 'LastName': 'Tanaka', 'Affiliation': 'Cardiovascular Aging Research Laboratory, The University of Texas at Austin, Department of Kinesiology and Health Education, Austin, TX, USA. Electronic address: htanaka@austin.utexas.edu.'}]",Journal of bodywork and movement therapies,['10.1016/j.jbmt.2019.04.005'] 1061,31732742,Effect of alirocumab on cardiovascular outcomes after acute coronary syndromes according to age: an ODYSSEY OUTCOMES trial analysis.,"AIMS Lowering low-density lipoprotein cholesterol (LDL-C) reduces cardiovascular risk irrespective of age, but the evidence is less strong for older patients. METHODS AND RESULTS This prespecified analysis from ODYSSEY OUTCOMES compared the effect of alirocumab vs. placebo in 18 924 patients with recent acute coronary syndrome (ACS) according to age. We examined the effect of assigned treatment on occurrence of the primary study outcome, a composite of coronary heart disease death, myocardial infarction, ischaemic stroke, or unstable angina requiring hospitalization [major adverse cardiovascular event (MACE)] and all-cause death. Relative risk reductions were consistent for patients ≥65 vs. <65 years for MACE [hazard ratio (HR) 0.78, 95% confidence interval (CI) 0.68-0.91 vs. 0.89, 0.80-1.00; Pinteraction = 0.19] and all-cause death [HR 0.77, 0.62-0.95 vs. 0.94, 0.77-1.15; Pinteraction = 0.46], and consistent for MACE when dichotomizing at age 75 years (HR 0.85, 0.64-1.13 in ≥75 vs. 0.85, 0.78-0.93 in <75, Pinteraction = 0.19). When considering age as a continuous variable in regression models, advancing age increased risk of MACE, as well as the absolute reduction in MACE with alirocumab, with numbers-needed-to-treat for MACE at 3 years of 43 (25-186) at age 45 years, 26 (15-97) at age 75 years, and 12 (6-81) for those at age 85 years. Although adverse events were more frequent in older patients, there were no differences between alirocumab and placebo. CONCLUSION In patients with recent ACS, alirocumab improves outcomes irrespective of age. Increasing absolute benefit but not harm with advancing age suggests that LDL-C lowering is an important preventive intervention for older patients after ACS.",2020,Increasing absolute benefit but not harm with advancing age suggests that LDL-C lowering is an important preventive intervention for older patients after ACS.,"['acute coronary syndromes according to age', 'older patients after ACS', '18\xa0924 patients with recent acute coronary syndrome (ACS) according to age', 'older patients']","['alirocumab vs. placebo', 'alirocumab', 'AIMS\n\n\nLowering low-density lipoprotein cholesterol (LDL-C']","['composite of coronary heart disease death, myocardial infarction, ischaemic stroke, or unstable angina requiring hospitalization [major adverse cardiovascular event (MACE', 'cardiovascular outcomes', 'adverse events', 'Relative risk reductions']","[{'cui': 'C0948089', 'cui_str': 'Acute Coronary Syndrome'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}]","[{'cui': 'C3491162', 'cui_str': 'alirocumab'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}]","[{'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0010068', 'cui_str': 'Coronary Disease'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C0002965', 'cui_str': 'Angina at Rest'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0349381', 'cui_str': 'Mace (substance)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0242492', 'cui_str': 'Relative Risk'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}]",,0.153476,Increasing absolute benefit but not harm with advancing age suggests that LDL-C lowering is an important preventive intervention for older patients after ACS.,"[{'ForeName': 'Peter R', 'Initials': 'PR', 'LastName': 'Sinnaeve', 'Affiliation': 'Department of Cardiovascular Medicine, University Hospitals Leuven, Herestraat 49, 3000 Leuven, Belgium.'}, {'ForeName': 'Gregory G', 'Initials': 'GG', 'LastName': 'Schwartz', 'Affiliation': 'Division of Cardiology, University of Colorado School of Medicine, Box B130, Aurora, CO 80045, USA.'}, {'ForeName': 'Daniel M', 'Initials': 'DM', 'LastName': 'Wojdyla', 'Affiliation': 'Duke Clinical Research Institute, Division of Cardiology, Duke University Medical Center, 200 Morris Street, Durham, NC 27701, USA.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Alings', 'Affiliation': 'Department of Cardiology, Amphia Ziekenhuis Molengracht, 4818 CK Breda, Netherlands.'}, {'ForeName': 'Deepak L', 'Initials': 'DL', 'LastName': 'Bhatt', 'Affiliation': ""Department of Medicine, Brigham and Women's Hospital Heart & Vascular Center and Harvard Medical School, 75 Francis Street, Boston, MA 02115, USA.""}, {'ForeName': 'Vera A', 'Initials': 'VA', 'LastName': 'Bittner', 'Affiliation': 'Division of Cardiovascular Disease, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Chern-En', 'Initials': 'CE', 'LastName': 'Chiang', 'Affiliation': 'General Clinical Research Center and Division of Cardiology, Taipei Veterans General Hospital and National Yang-Ming University, Shih-Pai Road, 11217 Taipei, Taiwan.'}, {'ForeName': 'Roger M', 'Initials': 'RM', 'LastName': 'Correa Flores', 'Affiliation': 'Department of Internal Medicine, Cardiology, Alberto Sabogal Sologuren, ESSALUD, Jirón Colina 1081, Bellavista - Callao, Lima CA01, Peru.'}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Diaz', 'Affiliation': 'Cardiology Department, Instituto Cardiovascular de Rosario, Paraguay 160, Santa Fe, Rosario 2000, Argentina.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Dorobantu', 'Affiliation': 'Cardiology Department, Emergency Clinical Hospital of Bucharest, 8 Calea Floreasca, ET 6 014461 Bucharest, Romania.'}, {'ForeName': 'Shaun G', 'Initials': 'SG', 'LastName': 'Goodman', 'Affiliation': 'Canadian VIGOUR Centre, University of Alberta, 87 Ave NW, Edmonton, Alberta T6G 2E1, Canada.'}, {'ForeName': 'J Wouter', 'Initials': 'JW', 'LastName': 'Jukema', 'Affiliation': 'Department of Cardiology, Leiden University Medical Center, PO Box 9600, 2300 RC Leiden, Netherlands.'}, {'ForeName': 'Yong-Un', 'Initials': 'YU', 'LastName': 'Kim', 'Affiliation': 'R&D Clinical Development, Sanofi, 1 avenue Pierre Brossolette, 91380 Chilly-Mazarin, France.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Pordy', 'Affiliation': 'Clinical Sciences - Cardiovascular & Metabolism Therapeutics, Regeneron Pharmaceuticals Inc., 777 Old Saw Mill River Rd, Tarrytown, NY 10591, USA.'}, {'ForeName': 'Matthew T', 'Initials': 'MT', 'LastName': 'Roe', 'Affiliation': 'Duke Clinical Research Institute, Division of Cardiology, Duke University Medical Center, 200 Morris Street, Durham, NC 27701, USA.'}, {'ForeName': 'Rody G', 'Initials': 'RG', 'LastName': 'Sy', 'Affiliation': 'Cardiovascular Institute, Cardinal Santos Medical Center, Wilson Street, San Juan, 1502 Metro Manila, Philippines.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Szarek', 'Affiliation': 'Downstate School of Public Health, State University of New York, 450 Clarkson Avenue, MS 43, Brooklyn, NY 11203 USA.'}, {'ForeName': 'Harvey D', 'Initials': 'HD', 'LastName': 'White', 'Affiliation': 'Green Lane Cardiovascular Services, Auckland 20 City Hospital, Auckland, New Zealand.'}, {'ForeName': 'Andreas M', 'Initials': 'AM', 'LastName': 'Zeiher', 'Affiliation': 'Department of Medicine III, Goethe University, Frankfurt am Main, Germany.'}, {'ForeName': 'Ph Gabriel', 'Initials': 'PG', 'LastName': 'Steg', 'Affiliation': 'Hopital Bichat, Universiteé de Paris, FACT (French Alliance for Cardiovascular Trials), INSERM U1148, Assistance Publique-Hopitaux de Paris, Paris, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",European heart journal,['10.1093/eurheartj/ehz809'] 1062,31074576,Efficacy of Computer-Based Telephone Counseling on Long-Term Adherence to Strength Training in Elderly Patients With Knee Osteoarthritis: A Randomized Trial.,"OBJECTIVE To determine whether the Boston Overcoming Osteoarthritis through Strength Training Telephone-Linked Communication (BOOST-TLC) program, a novel telephone-based, motivational, strength-training exercise-adherence counseling intervention, improved adherence to a strength-training exercise program over 2 years. METHODS Participants were recruited for this 2-year, single-blind, parallel-arm randomized controlled trial from knee osteoarthritis patient registries, community newspapers, and online websites in Massachusetts. Eligibility criteria included age 50 years or older, painful knee osteoarthritis, and ability to use a telephone. Exclusion criteria included medical conditions precluding exercise, inflammatory arthritis, current regular strength training, planned knee replacement surgery, dementia, inability to follow exercise instructions, and inability to use the TLC system. After participating in a group exercise class, participants were randomized to receiving motivational telephone calls through the BOOST-TLC program for 24 months or the control. Both control and intervention participants received a monthly automated phone message reminder to continue the program. Exercise adherence was ascertained by a single self-report item scored 0-10, where 10 represented complete adherence. Outcomes were evaluated at 6, 12, 18, and 24 months. RESULTS A total of 104 subjects were randomized, and 89 subjects (44 control, 45 TLC) completed the 24-month follow-up. There was no significant difference in adherence at 24 months between groups (mean for control group 4.01 [95% confidence interval (95% CI) 3.03, 4.99], mean for TLC subjects 3.63 [95% CI 2.70, 4.56]; P = 0.57). CONCLUSION In those with knee osteoarthritis who had participated in an exercise program, frequent motivational telephone reminders did not increase adherence to strength-training exercise.",2020,"There was no significant difference in adherence at 24-months between groups (4.01 (3.03, 4.99) in controls, 3.63 (2.70, 4.56) in TLC subjects, p=0.57). ","['104 subjects were randomized and 89 subjects (44 control, 45 TLC) completed the 24-month follow-up', 'Eligibility criteria included age 50 or older, painful knee osteoarthritis and ability to use a telephone', 'Participants were recruited from knee osteoarthritis patient registries, community newspapers, and online websites', 'Elders with Knee Osteoarthritis']","['telephone-based motivational strength training exercise adherence counseling intervention', 'Strength Training', 'Computer-based Telephone Counseling', 'exercise program, frequent motivational telephone reminders', 'motivational telephone calls through the BOOST-TLC program', 'Boston Overcoming Osteoarthritis through Strength Training Telephone-Linked Communication (BOOST-TLC) program']","['adherence to strength training exercise', 'adherence', 'Exercise adherence']","[{'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0040509', 'cui_str': 'Total Lung Capacity'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0231749', 'cui_str': 'Knee pain (finding)'}, {'cui': 'C0029408', 'cui_str': 'Arthritis, Degenerative'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis, Knee'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0027989', 'cui_str': 'Newspapers'}]","[{'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0009622', 'cui_str': 'Computers'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0332183', 'cui_str': 'Frequent (qualifier value)'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0040509', 'cui_str': 'Total Lung Capacity'}, {'cui': 'C0006037', 'cui_str': 'Boston'}, {'cui': 'C0029408', 'cui_str': 'Arthritis, Degenerative'}, {'cui': 'C0009452', 'cui_str': 'Communication'}]","[{'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]",104.0,0.0351411,"There was no significant difference in adherence at 24-months between groups (4.01 (3.03, 4.99) in controls, 3.63 (2.70, 4.56) in TLC subjects, p=0.57). ","[{'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Baker', 'Affiliation': 'Boston University, Boston, Massachusetts.'}, {'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'LaValley', 'Affiliation': 'Boston University, Boston, Massachusetts.'}, {'ForeName': 'Carrie', 'Initials': 'C', 'LastName': 'Brown', 'Affiliation': 'Boston University, Boston, Massachusetts.'}, {'ForeName': 'David T', 'Initials': 'DT', 'LastName': 'Felson', 'Affiliation': 'Boston University, Boston, Massachusetts.'}, {'ForeName': 'Aileen', 'Initials': 'A', 'LastName': 'Ledingham', 'Affiliation': 'Boston University, Boston, Massachusetts.'}, {'ForeName': 'Julie J', 'Initials': 'JJ', 'LastName': 'Keysor', 'Affiliation': 'MGH Institute of Health Professions, Boston, Massachusetts.'}]",Arthritis care & research,['10.1002/acr.23921'] 1063,31734805,Comparison of percutaneous transforaminal endoscopic lumbar discectomy through unilateral versus bilateral approach for L3/4 or L4/5 lumbar disc herniation with bilateral symptoms: technical notes and a prospective randomized study.,"PURPOSE In this study, the authors described the technical notes of percutaneous transforaminal endoscopic lumbar discectomy (PTELD) through unilateral approach and compared PTELD through unilateral versus bilateral approach for L3/4 or L4/5 lumbar disc herniation with bilateral symptoms. METHODS A prospective randomized clinical study was performed from June 2014 to October 2016. A total of 71 patients with lumbar disc herniation (L3/4 or L4/5) and bilateral symptoms were divided randomly into Unilateral-Approach group (n = 35) or Bilateral-Approach group (n = 36). Operation time, blood loss, intraoperative fluoroscopy and recurrences were recorded and analyzed statistically. Visual Analogue Scale scores, Oswestry Disability Index and the MacNab standard were used to analyze the clinical outcomes of the two groups. RESULTS The baseline data of the two groups were statistically similar. There was significant postoperative improvement in VAS and ODI scores in both the groups, and clinical outcomes are comparable according to the MacNab standard. However, VAS score of back pain at 1 day after surgery in Unilateral-Approach group was significantly lower than that in Bilateral-Approach group (P < 0.05). Moreover, operation time and cumulative time of intraoperative fluoroscopy of Unilateral-Approach group were significantly shorter than that of Bilateral-Approach group (P < 0.05). CONCLUSION For L3/4 or L4/5 LDH with bilateral symptoms, PTELD through unilateral approach is effective, with advantage of shorter operation time, shorter cumulative time of intraoperative fluoroscopy and milder postoperative short-term back pain compared to bilateral approach. These slides can be retrieved under Electronic Supplementary Material.",2020,"There was significant postoperative improvement in VAS and ODI scores in both the groups, and clinical outcomes are comparable according to the MacNab standard.","['for L3/4 or L4/5 lumbar disc herniation with bilateral symptoms', '71 patients with lumbar disc herniation (L3/4 or L4/5) and bilateral symptoms', 'June 2014 to October 2016', 'L3/4 or L4/5 lumbar disc herniation with bilateral symptoms']","['Unilateral-Approach group (n\u2009=\u200935) or Bilateral-Approach group', 'percutaneous transforaminal endoscopic lumbar discectomy (PTELD) through unilateral approach and compared PTELD through unilateral versus bilateral approach', 'percutaneous transforaminal endoscopic lumbar discectomy through unilateral versus bilateral approach']","['cumulative time of intraoperative fluoroscopy and milder postoperative short-term back pain', 'Operation time, blood loss, intraoperative fluoroscopy and recurrences', 'Visual Analogue Scale scores, Oswestry Disability Index', 'VAS score of back pain', 'operation time and cumulative time of intraoperative fluoroscopy', 'VAS and ODI scores']","[{'cui': 'C0281899', 'cui_str': 'Prolapsed lumbar intervertebral disc (disorder)'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach - access (qualifier value)'}, {'cui': 'C0408632', 'cui_str': 'Excision of lumbar intervertebral disc (procedure)'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0016356', 'cui_str': 'Fluoroscopy'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0004604', 'cui_str': 'Backache'}, {'cui': 'C0038895', 'cui_str': 'operative therapy'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index (assessment scale)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",71.0,0.0439199,"There was significant postoperative improvement in VAS and ODI scores in both the groups, and clinical outcomes are comparable according to the MacNab standard.","[{'ForeName': 'Kang', 'Initials': 'K', 'LastName': 'Li', 'Affiliation': ""Department of Spine Surgery, Jining No. 1 People's Hospital, 6 Jiankang Road, Jining, 272000, Shandong Province, People's Republic of China.""}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Gao', 'Affiliation': ""Department of Joint Surgery, Jining No. 1 People's Hospital, 6 Jiankang Road, Jining, 272000, Shandong Province, People's Republic of China.""}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Zhang', 'Affiliation': ""Department of Spine Surgery, Jining No. 1 People's Hospital, 6 Jiankang Road, Jining, 272000, Shandong Province, People's Republic of China.""}, {'ForeName': 'Chao-Liang', 'Initials': 'CL', 'LastName': 'Lv', 'Affiliation': ""Department of Spine Surgery, Jining No. 1 People's Hospital, 6 Jiankang Road, Jining, 272000, Shandong Province, People's Republic of China. lvchaoliang2018@126.com.""}]","European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society",['10.1007/s00586-019-06210-y'] 1064,29678137,Supporting teams to optimize function and independence in Veterans: a multi-study program and mixed methods protocol.,"BACKGROUND Successful implementation of new clinical programs depends on effectively establishing, reorganizing, or enhancing team structures and processes to coordinate the work of individuals who are interdependent in their tasks, manage relationships, and share responsibility for outcomes. However, a one-size-fits-all approach is rarely effective. In partnership with VA national clinical leaders and local clinical champions, the Optimizing Function and Independence VA Quality Enhancement Research Initiative program (Function QUERI) will evaluate efforts to implement team-based clinical programs for Veterans at risk for functional decline and disability. METHODS Function QUERI will implement and evaluate three innovative, evidence-based clinical programs in VA medical centers: (1) a group physical therapy program for knee osteoarthritis (Group PT); (2) assisted early mobility for hospitalized older veterans (STRIDE), a supervised walking program for hospitalized older veterans; and (3) implementation of helping invested family members improve veteran experiences study (iHI-FIVES), a skills training program for caregivers of disabled Veterans. A common reason for clinical care gaps in these populations is poor communication and coordination among the many interdisciplinary providers involved in their care. To facilitate the implementation of the clinical programs, Function QUERI will evaluate the impact of complexity science-based implementation intervention to promote team readiness (CONNECT), an implementation intervention designed as a bundle of interaction-oriented activities to promote team function and readiness for change, on the implementation of clinical programs across multiple sites. The evaluation will use a mixed methods design. Group PT is a local, single-site quality improvement project where a modified CONNECT intervention will be tested to inform the remaining program implementation projects. For STRIDE and iHI-FIVES projects, we will randomize participating sites to implement the clinical program, with the CONNECT intervention or not, and will use a stepped-wedge cluster randomized trial design. DISCUSSION Function QUERI will translate its findings across its projects to identify the contextual factors and components from CONNECT that improve team processes and function to optimize effective implementation for future rollout of VA clinical programs. Synthesizing findings within and across projects, we will specify dimensions of team characteristics and function that enhance capacity for clinical innovation and uptake of evidence-based programs. TRIAL REGISTRATION NCT03300336 Registered September 28, 2017, NCT03474380 Registered March 15, 2018.",2018,"Group PT is a local, single-site quality improvement project where a modified CONNECT intervention will be tested to inform the remaining program implementation projects.","['for caregivers of disabled Veterans', 'Veterans', 'hospitalized older veterans (STRIDE']","['supervised walking program for hospitalized older veterans; and (3) implementation of helping invested family members improve veteran experiences study (iHI-FIVES), a skills training program', 'physical therapy program for knee osteoarthritis (Group PT); (2) assisted early mobility']",[],"[{'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0086282', 'cui_str': 'Person in the family'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0559197', 'cui_str': 'Skills training (procedure)'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis, Knee'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}]",[],,0.0464389,"Group PT is a local, single-site quality improvement project where a modified CONNECT intervention will be tested to inform the remaining program implementation projects.","[{'ForeName': 'Virginia', 'Initials': 'V', 'LastName': 'Wang', 'Affiliation': 'Health Services Research and Development Center of Innovation, Durham Veterans Affairs Health Care System, 508 Fulton St., Durham, NC, 27705, USA. virginia.wang@va.gov.'}, {'ForeName': 'Kelli', 'Initials': 'K', 'LastName': 'Allen', 'Affiliation': 'Health Services Research and Development Center of Innovation, Durham Veterans Affairs Health Care System, 508 Fulton St., Durham, NC, 27705, USA.'}, {'ForeName': 'Courtney H', 'Initials': 'CH', 'LastName': 'Van Houtven', 'Affiliation': 'Health Services Research and Development Center of Innovation, Durham Veterans Affairs Health Care System, 508 Fulton St., Durham, NC, 27705, USA.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Coffman', 'Affiliation': 'Health Services Research and Development Center of Innovation, Durham Veterans Affairs Health Care System, 508 Fulton St., Durham, NC, 27705, USA.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Sperber', 'Affiliation': 'Health Services Research and Development Center of Innovation, Durham Veterans Affairs Health Care System, 508 Fulton St., Durham, NC, 27705, USA.'}, {'ForeName': 'Elizabeth P', 'Initials': 'EP', 'LastName': 'Mahanna', 'Affiliation': 'Health Services Research and Development Center of Innovation, Durham Veterans Affairs Health Care System, 508 Fulton St., Durham, NC, 27705, USA.'}, {'ForeName': 'Cathleen', 'Initials': 'C', 'LastName': 'Colón-Emeric', 'Affiliation': 'Health Services Research and Development Center of Innovation, Durham Veterans Affairs Health Care System, 508 Fulton St., Durham, NC, 27705, USA.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Hoenig', 'Affiliation': 'Health Services Research and Development Center of Innovation, Durham Veterans Affairs Health Care System, 508 Fulton St., Durham, NC, 27705, USA.'}, {'ForeName': 'George L', 'Initials': 'GL', 'LastName': 'Jackson', 'Affiliation': 'Health Services Research and Development Center of Innovation, Durham Veterans Affairs Health Care System, 508 Fulton St., Durham, NC, 27705, USA.'}, {'ForeName': 'Teresa M', 'Initials': 'TM', 'LastName': 'Damush', 'Affiliation': 'Health Services Research and Development Center for Health Information and Communication, Roudebush Veterans Affairs Medical Center, 1481 W. 10th St., HSRD 11H, Indianapolis, IN, 46202, USA.'}, {'ForeName': 'Erika', 'Initials': 'E', 'LastName': 'Price', 'Affiliation': 'San Francisco VA Care System, 94121, 4150 Celement St., Box 111, San Francisco, CA, USA.'}, {'ForeName': 'Susan N', 'Initials': 'SN', 'LastName': 'Hastings', 'Affiliation': 'Health Services Research and Development Center of Innovation, Durham Veterans Affairs Health Care System, 508 Fulton St., Durham, NC, 27705, USA.'}]",Implementation science : IS,['10.1186/s13012-018-0748-3'] 1065,31732448,Pooled Dosing and Efficacy Analysis of the Sufentanil Sublingual Tablet 30 mcg Across Demographic Subgroups for the Management of Moderate-to-Severe Acute Pain.,"PURPOSE To aid nurses in dosing sufentanil sublingual tablet (SST) 30 mcg administered via a single-dose applicator, dosing requirements and efficacy of SST 30 mcg were analyzed across age, sex, race, and body mass index subgroups. DESIGN Patient characteristics were pooled from three postoperative studies (two placebo-controlled and one open-label) and one open-label emergency department study. Drug dosing and efficacy data were pooled from the postoperative studies. METHODS Efficacy was assessed through summed pain intensity difference to baseline during 12 hours across subgroups. FINDINGS Mean (standard deviation) drug doses administered from 0 to 12 hours was 3.9 (2.0) for SST 30 mcg and was less frequent for older (≥65 years) versus younger patients. The summed pain intensity difference to baseline during 12 hours was superior with SST 30 mcg versus placebo across all subgroups. CONCLUSIONS SST 30 mcg is a sublingual opioid analgesic with efficacy across demographic subgroups.",2020,"The summed pain intensity difference to baseline during 12 hours was superior with SST 30 mcg versus placebo across all subgroups. ","['Patient characteristics were pooled from three postoperative studies (two placebo-controlled and one open-label) and one open-label emergency department study', 'Moderate-to-Severe Acute Pain']","['SST 30 mcg versus placebo', 'sufentanil sublingual tablet (SST', 'Sufentanil Sublingual Tablet']","['Efficacy', 'summed pain intensity difference']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0337051', 'cui_str': 'Pool (environment)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0184567', 'cui_str': 'Acute Pain'}]","[{'cui': 'C0439211', 'cui_str': 'microgram'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0143993', 'cui_str': 'Sufentanil'}, {'cui': 'C0991582', 'cui_str': 'Sublingual Tablet'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}]",,0.0884864,"The summed pain intensity difference to baseline during 12 hours was superior with SST 30 mcg versus placebo across all subgroups. ","[{'ForeName': 'Jacob L', 'Initials': 'JL', 'LastName': 'Hutchins', 'Affiliation': 'Department of Anesthesiology, University of Minnesota, Minneapolis, MN.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Leiman', 'Affiliation': 'Department of Surgery, University of Texas at Houston, and HD Research Corp, Houston, TX.'}, {'ForeName': 'Zubaid', 'Initials': 'Z', 'LastName': 'Rafique', 'Affiliation': 'Department of Emergency Medicine, Baylor College of Medicine, Ben Taub General Hospital, Houston, TX.'}, {'ForeName': 'Karen P', 'Initials': 'KP', 'LastName': 'DiDonato', 'Affiliation': 'Medical Affairs, AcelRx Pharmaceuticals, Redwood City, CA.'}, {'ForeName': 'Pamela P', 'Initials': 'PP', 'LastName': 'Palmer', 'Affiliation': 'Medical Affairs, AcelRx Pharmaceuticals, Redwood City, CA. Electronic address: ppalmer@acelrx.com.'}]",Journal of perianesthesia nursing : official journal of the American Society of PeriAnesthesia Nurses,['10.1016/j.jopan.2019.08.009'] 1066,30860603,"The Interplay Between Subjective Response to Alcohol, Craving, and Alcohol Self-Administration in the Human Laboratory.","BACKGROUND Despite a rich literature on human laboratory paradigms of subjective response (SR) to alcohol, craving for alcohol, and alcohol self-administration, few studies have examined the interplay across these 3 constructs. The present study addresses this gap in the literature by examining the interplay between SR, craving, and self-administration in the human laboratory. METHODS Data were culled from a medication study (NCT02026011) in which heavy drinking participants of East Asian ancestry completed 2 double-blinded and counterbalanced experimental sessions. In each experimental session, participants received a priming dose of intravenous (IV) alcohol to a target breath alcohol concentration (BrAC) of 0.06 g/dl and measures of SR (stimulation and sedation) and alcohol craving were collected across rising BrACs. The IV alcohol challenge was immediately followed by a 1-hour alcohol self-administration period. RESULTS Mixed model analyses found a positive and significant relationship between the slope of stimulation and the slope of craving during the alcohol challenge. The relationship between sedation and craving, however, was not significant. The slope of craving during the alcohol challenge significantly predicted a higher number of mini-drinks consumed and lower latency to first drink. Further, mediation analyses found that craving was a significant mediator of the relationship between stimulation and total number of mini-drinks consumed, but the same pattern was not found for sedation. CONCLUSIONS Insofar as alcohol self-administration represents the end point of interest for a host of experimental and clinical research questions, the present study suggests that alcohol craving represents a more proximal predictor of self-administration than measures of alcohol-induced stimulation. It is recommended that human laboratory models interpret measures of SR and craving in light of their relative predictive utility for drinking outcomes.",2019,The slope of craving during the alcohol challenge significantly predicted a higher number of mini-drinks consumed and lower latency to first drink.,['Data were culled from a medication study (NCT02026011) in which heavy drinking participants of East Asian ancestry completed 2 double-blinded and counterbalanced experimental sessions'],['intravenous (IV) alcohol'],"['slope of craving', 'slope of stimulation and the slope of craving']","[{'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439539', 'cui_str': 'Heavy sensation quality'}, {'cui': 'C0684271', 'cui_str': 'Drinkings'}, {'cui': 'C0078988', 'cui_str': 'Asians'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}]","[{'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}]",,0.0156351,The slope of craving during the alcohol challenge significantly predicted a higher number of mini-drinks consumed and lower latency to first drink.,"[{'ForeName': 'ReJoyce', 'Initials': 'R', 'LastName': 'Green', 'Affiliation': 'Department of Psychology, University of California, Los Angeles, Los Angeles, California.'}, {'ForeName': 'Erica', 'Initials': 'E', 'LastName': 'Grodin', 'Affiliation': 'Department of Psychology, University of California, Los Angeles, Los Angeles, California.'}, {'ForeName': 'Aaron C', 'Initials': 'AC', 'LastName': 'Lim', 'Affiliation': 'Department of Psychology, University of California, Los Angeles, Los Angeles, California.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Venegas', 'Affiliation': 'Department of Psychology, University of California, Los Angeles, Los Angeles, California.'}, {'ForeName': 'Spencer', 'Initials': 'S', 'LastName': 'Bujarski', 'Affiliation': 'Department of Psychology, University of California, Los Angeles, Los Angeles, California.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Krull', 'Affiliation': 'Department of Psychology, University of California, Los Angeles, Los Angeles, California.'}, {'ForeName': 'Lara A', 'Initials': 'LA', 'LastName': 'Ray', 'Affiliation': 'Department of Psychology, University of California, Los Angeles, Los Angeles, California.'}]","Alcoholism, clinical and experimental research",['10.1111/acer.14001'] 1067,31062377,Oropharyngeal Administration of Mother's Milk Prior to Gavage Feeding in Preterm Infants: A Pilot Randomized Control Trial.,"BACKGROUND Oropharyngeal administration of mother's colostrum in early days has an immunoprotective effect in preterm infants. OBJECTIVES Our aim was to study the effect of oropharyngeal administration of mother's milk (OPAMM) on decreasing the incidence of nosocomial sepsis. METHODS In a pilot prospective randomized study on preterm (<32 weeks gestation and 1500 g weight) infants, we compared OPAMM practice (applying 0.2 mL of mother's colostrum or milk prior to gavage feeding until full oral feeding is reached) with regular gavage feeding. The primary outcome was incidence of culture-proven nosocomial sepsis. Secondary outcomes included bacterial colonization of the gastrointestinal tract, feeding intolerance, time to reach full feeding, incidence of necrotizing enterocolitis, ventilator-associated pneumonia, duration of respiratory support, incidence of bronchopulmonary dysplasia (BPD), length of hospital stay, and neonatal mortality. RESULTS The outcomes of 200 neonates (100 in each group) were analyzed. OPAMM practice did not significantly reduce the incidence of culture proven nosocomial sepsis (8% vs 13%, P = 0.35). Infants in the OPAMM group had a significantly lower growth of Klebsiella species in the oropharyngeal pouch, borderline lower incidence of ventilator-associated pneumonia, shorter duration of oxygen therapy, less episodes of feeding intolerance, reached full feeding earlier, and had a shorter length of hospital stay. OPAMM practice did not affect the incidence of necrotizing enterocolitis, BPD, or neonatal mortality. CONCLUSION OPAMM prior to gavage feeding does not reduce the incidence of nosocomial sepsis but had beneficial effects on early achievement of feeding, and early hospital discharge in preterm very low-birth-weight infants.",2020,"Infants in the OPAMM group had a significantly lower growth of Klebsiella species in the oropharyngeal pouch, borderline lower incidence of ventilator-associated pneumonia, shorter duration of oxygen therapy, less episodes of feeding intolerance, reached full feeding earlier, and had a shorter length of hospital stay.","['200 neonates (100 in each group) were analyzed', 'preterm very low-birth-weight infants', ""Oropharyngeal Administration of Mother's Milk"", 'preterm (<32\xa0weeks gestation and 1500\xa0g weight) infants', 'Preterm Infants', 'preterm infants']","['OPAMM', ""oropharyngeal administration of mother's milk (OPAMM"", ""OPAMM practice (applying 0.2\xa0mL of mother's colostrum or milk prior to gavage feeding until full oral feeding is reached) with regular gavage feeding""]","['ventilator-associated pneumonia, shorter duration of oxygen therapy, less episodes of feeding intolerance', 'shorter length of hospital stay', 'incidence of nosocomial sepsis', 'bacterial colonization of the gastrointestinal tract, feeding intolerance, time to reach full feeding, incidence of necrotizing enterocolitis, ventilator-associated pneumonia, duration of respiratory support, incidence of bronchopulmonary dysplasia (BPD), length of hospital stay, and neonatal mortality', 'growth of Klebsiella species', 'incidence of culture proven nosocomial sepsis', 'necrotizing enterocolitis, BPD, or neonatal mortality', 'incidence of culture-proven nosocomial sepsis']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0282667', 'cui_str': 'Infant, Very Low Birth Weight'}, {'cui': 'C1522409', 'cui_str': 'Oropharyngeal route (qualifier value)'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0026140', 'cui_str': 'Breast Milk'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C4517582', 'cui_str': '1500'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C4048294', 'cui_str': 'Preterm Infant'}]","[{'cui': 'C1522409', 'cui_str': 'Oropharyngeal route (qualifier value)'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0026140', 'cui_str': 'Breast Milk'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C4517436', 'cui_str': '0.2'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0009413', 'cui_str': 'Colostrum'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0041281', 'cui_str': 'Tube Feeding'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0596012', 'cui_str': 'Does reach (finding)'}, {'cui': 'C0205272', 'cui_str': 'Regular (qualifier value)'}, {'cui': 'C2987508', 'cui_str': 'Feeding (observable entity)'}]","[{'cui': 'C0087153', 'cui_str': 'Ventilators'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0439593', 'cui_str': 'Short duration (qualifier value)'}, {'cui': 'C0184633', 'cui_str': 'Oxygen Inhalation Therapy'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C1820738', 'cui_str': 'Feeding intolerance'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0243026', 'cui_str': 'Sepsis'}, {'cui': 'C2747813', 'cui_str': 'Bacterial colonisation'}, {'cui': 'C0017189', 'cui_str': 'Gastrointestinal Tract'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0596012', 'cui_str': 'Does reach (finding)'}, {'cui': 'C0520459', 'cui_str': 'Necrotizing Enterocolitis'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0006287', 'cui_str': 'Bronchopulmonary Dysplasia'}, {'cui': 'C0027616', 'cui_str': 'Neonatal Mortality'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0022727', 'cui_str': 'Klebsiella'}, {'cui': 'C0220814', 'cui_str': 'culture'}, {'cui': 'C0456369', 'cui_str': 'Proven (qualifier value)'}]",,0.101787,"Infants in the OPAMM group had a significantly lower growth of Klebsiella species in the oropharyngeal pouch, borderline lower incidence of ventilator-associated pneumonia, shorter duration of oxygen therapy, less episodes of feeding intolerance, reached full feeding earlier, and had a shorter length of hospital stay.","[{'ForeName': 'Mahmoud', 'Initials': 'M', 'LastName': 'Abd-Elgawad', 'Affiliation': ""Neonatal Intensive Care Unit, Mansoura University Children's Hospital, Mansoura, Dakahlia, Egypt.""}, {'ForeName': 'Heba', 'Initials': 'H', 'LastName': 'Eldegla', 'Affiliation': 'Department of Medical Microbiology and Immunology, Faculty of Medicine, University of Mansoura, Mansoura, Egypt.'}, {'ForeName': 'Mohammed', 'Initials': 'M', 'LastName': 'Khashaba', 'Affiliation': ""Neonatal Intensive Care Unit, Mansoura University Children's Hospital, Mansoura, Dakahlia, Egypt.""}, {'ForeName': 'Nehad', 'Initials': 'N', 'LastName': 'Nasef', 'Affiliation': ""Neonatal Intensive Care Unit, Mansoura University Children's Hospital, Mansoura, Dakahlia, Egypt.""}]",JPEN. Journal of parenteral and enteral nutrition,['10.1002/jpen.1601'] 1068,31732485,"Bedaquiline, moxifloxacin, pretomanid, and pyrazinamide during the first 8 weeks of treatment of patients with drug-susceptible or drug-resistant pulmonary tuberculosis: a multicentre, open-label, partially randomised, phase 2b trial.","BACKGROUND New anti-tuberculosis regimens that are shorter, simpler, and less toxic than those that are currently available are needed as part of the global effort to address the tuberculosis epidemic. We aimed to investigate the bactericidal activity and safety profile of combinations of bedaquiline, pretomanid, moxifloxacin, and pyrazinamide in the first 8 weeks of treatment of pulmonary tuberculosis. METHODS In this multicentre, open-label, partially randomised, phase 2b trial, we prospectively recruited patients with drug-susceptible or rifampicin-resistant pulmonary tuberculosis from seven sites in South Africa, two in Tanzania, and one in Uganda. Patients aged 18 years or older with sputum smear grade 1+ or higher were eligible for enrolment, and a molecular assay (GeneXpert or MTBDRplus) was used to confirm the diagnosis of tuberculosis and to distinguish between drug-susceptible and rifampicin-resistant tuberculosis. Patients who were HIV positive with a baseline CD4 cell count of less than 100 cells per uL were excluded. Patients with drug-susceptible tuberculosis were randomly assigned (1:1:1) using numbered treatment packs with sequential allocation by the pharmacist to receive 56 days of treatment with standard tuberculosis therapy (oral isoniazid, rifampicin, pyrazinamide, and ethambutol; HRZE), or pretomanid (oral 200 mg daily) and pyrazinamide (oral 1500 mg daily) with either oral bedaquiline 400 mg daily on days 1-14 then 200 mg three times per week (B load PaZ) or oral bedaquiline 200 mg daily (B 200 PaZ). Patients with rifampicin-resistant tuberculosis received 56 days of the B 200 PaZ regimen plus moxifloxacin 400 mg daily (BPaMZ). All treatment groups were open label, and randomisation was not stratified. Patients, trial investigators and staff, pharmacists or dispensers, laboratory staff (with the exception of the mycobacteriology laboratory staff), sponsor staff, and applicable contract research organisations were not masked. The primary efficacy outcome was daily percentage change in time to sputum culture positivity (TTP) in liquid medium over days 0-56 in the drug-susceptible tuberculosis population, based on non-linear mixed-effects regression modelling of log 10 (TTP) over time. The efficacy analysis population contained patients who received at least one dose of medication and who had efficacy data available and had no major protocol violations. The safety population contained patients who received at least one dose of medication. This study is registered with ClinicalTrials.gov, NCT02193776, and all patients have completed follow-up. FINDINGS Between Oct 24, 2014, and Dec 15, 2015, we enrolled 180 patients with drug-susceptible tuberculosis (59 were randomly assigned to B load PaZ, 60 to B 200 PaZ, and 61 to HRZE) and 60 patients with rifampicin-resistant tuberculosis. 57 patients in the B load PaZ group, 56 in the B 200 PaZ group, and 59 in the HRZE group were included in the primary analysis. B 200 PaZ produced the highest daily percentage change in TTP (5·17% [95% Bayesian credibility interval 4·61-5·77]), followed by B load PaZ (4·87% [4·31-5·47]) and HRZE group (4·04% [3·67-4·42]). The bactericidal activity in B 200 PaZ and B load PaZ groups versus that in the HRZE group was significantly different. Higher proportions of patients in the B load PaZ (six [10%] of 59) and B 200 PaZ (five [8%] of 60) groups discontinued the study drug than in the HRZE group (two [3%] of 61) because of adverse events. Liver enzyme elevations were the most common grade 3 or 4 adverse events and resulted in the withdrawal of ten patients (five [8%] in the B load PaZ group, three [5%] in the B 200 PaZ group, and two [3%] in the HRZE group). Serious treatment-related adverse events affected two (3%) patients in the B load PaZ group and one (2%) patient in the HRZE group. Seven (4%) patients with drug-susceptible tuberculosis died and four (7%) patients with rifampicin-resistant tuberculosis died. None of the deaths were considered to be related to treatment. INTERPRETATION B 200 PaZ is a promising regimen to treat patients with drug-susceptible tuberculosis. The bactericidal activity of both these regimens suggests that they have the potential to shorten treatment, and the simplified dosing schedule of B 200 PaZ could improve treatment adherence in the field. However, these findings must be investigated further in a phase 3 trial assessing treatment outcomes. FUNDING TB Alliance, UK Department for International Development, Bill & Melinda Gates Foundation, US Agency for International Development, Directorate General for International Cooperation of the Netherlands, Irish Aid, Australia Department of Foreign Affairs and Trade, and the Federal Ministry for Education and Research of Germany.",2019,"B 200 PaZ produced the highest daily percentage change in TTP (5·17% [95% Bayesian credibility interval 4·61-5·77]), followed by B load PaZ (4·87% [4·31-5·47]) and HRZE group (4·04% [3·67-4·42]).","['57 patients in the B load PaZ group, 56 in the B 200 PaZ group, and 59 in the HRZE group were included in the primary analysis', 'Patients, trial investigators and staff, pharmacists or dispensers, laboratory staff (with the exception of the mycobacteriology laboratory staff), sponsor staff, and applicable contract research organisations were not masked', 'Patients with rifampicin-resistant tuberculosis', 'pulmonary tuberculosis', 'Patients aged 18 years or older with sputum smear grade 1+ or higher were eligible for enrolment, and a molecular assay (GeneXpert or MTBDRplus) was used to confirm the diagnosis of tuberculosis and to distinguish between drug-susceptible and rifampicin-resistant tuberculosis', 'Patients who were HIV positive with a baseline CD4 cell count of less than 100 cells per uL were excluded', 'Patients with drug-susceptible tuberculosis', 'Between Oct 24, 2014, and Dec 15, 2015, we enrolled 180 patients with drug-susceptible tuberculosis (59', 'patients with drug-susceptible or drug-resistant pulmonary tuberculosis', 'patients with drug-susceptible or rifampicin-resistant pulmonary tuberculosis from seven sites in South Africa, two in Tanzania, and one in Uganda', 'patients with drug-susceptible tuberculosis']","['oral bedaquiline', 'standard tuberculosis therapy (oral isoniazid, rifampicin, pyrazinamide, and ethambutol; HRZE), or pretomanid (oral 200 mg daily) and pyrazinamide (oral 1500 mg daily) with either oral bedaquiline', 'Bedaquiline, moxifloxacin, pretomanid, and pyrazinamide', 'bedaquiline, pretomanid, moxifloxacin, and pyrazinamide', 'HRZE', 'rifampicin-resistant tuberculosis', 'moxifloxacin 400 mg daily (BPaMZ']","['Liver enzyme elevations', 'adverse events', 'daily percentage change in time to sputum culture positivity (TTP', 'bactericidal activity', 'TTP']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0035173', 'cui_str': 'Investigators'}, {'cui': 'C2700616', 'cui_str': 'Manpowers'}, {'cui': 'C0031323', 'cui_str': 'Pharmacist'}, {'cui': 'C0180463', 'cui_str': 'Dispenser'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0332522', 'cui_str': 'Contracts'}, {'cui': 'C0035168'}, {'cui': 'C0029237', 'cui_str': 'Organization (morphologic abnormality)'}, {'cui': 'C0024861', 'cui_str': 'Masks'}, {'cui': 'C1532782', 'cui_str': 'Rifampicin resistant tuberculosis'}, {'cui': 'C0041327', 'cui_str': 'Pulmonary Phthisis'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0038056', 'cui_str': 'Sputum'}, {'cui': 'C0444186', 'cui_str': 'Smear test'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C1510438', 'cui_str': 'Assay technique (qualifier value)'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0041296', 'cui_str': 'Mycobacterium tuberculosis Infection'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0231204', 'cui_str': 'Susceptible (qualifier value)'}, {'cui': 'C0019699', 'cui_str': 'HTLV-III Seroconversion'}, {'cui': 'C0243009', 'cui_str': 'CD4+ Counts'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0332325', 'cui_str': 'Resistant (qualifier value)'}, {'cui': 'C0035608', 'cui_str': 'rifampicin'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0037712', 'cui_str': 'Union of South Africa'}, {'cui': 'C0039298', 'cui_str': 'United Republic of Tanzania'}, {'cui': 'C0041573', 'cui_str': 'Republic of Uganda'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C1664205', 'cui_str': 'bedaquiline'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0041296', 'cui_str': 'Mycobacterium tuberculosis Infection'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0022209', 'cui_str': 'isoniazid'}, {'cui': 'C0035608', 'cui_str': 'rifampicin'}, {'cui': 'C0034239', 'cui_str': 'Pyrazinamide'}, {'cui': 'C0014964', 'cui_str': 'Ethambutol'}, {'cui': 'C4310440'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C4517582', 'cui_str': '1500'}, {'cui': 'C0536495', 'cui_str': 'moxifloxacin'}, {'cui': 'C1532782', 'cui_str': 'Rifampicin resistant tuberculosis'}, {'cui': 'C1592286', 'cui_str': 'moxifloxacin 400 MG [Avelox]'}]","[{'cui': 'C0443764', 'cui_str': 'Liver enzyme (substance)'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0523174', 'cui_str': 'Microbial culture of sputum (procedure)'}, {'cui': 'C0034155', 'cui_str': 'Moschkowitz Disease'}, {'cui': 'C0544570', 'cui_str': 'Bactericidal activity (observable entity)'}]",180.0,0.193834,"B 200 PaZ produced the highest daily percentage change in TTP (5·17% [95% Bayesian credibility interval 4·61-5·77]), followed by B load PaZ (4·87% [4·31-5·47]) and HRZE group (4·04% [3·67-4·42]).","[{'ForeName': 'Conor D', 'Initials': 'CD', 'LastName': 'Tweed', 'Affiliation': 'MRC Clinical Trials Unit at UCL, London, UK. Electronic address: c.tweed@ucl.ac.uk.'}, {'ForeName': 'Rodney', 'Initials': 'R', 'LastName': 'Dawson', 'Affiliation': 'University of Cape Town Lung Institute, Cape Town, South Africa; Division of Pulmonology, Department of Medicine, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Divan A', 'Initials': 'DA', 'LastName': 'Burger', 'Affiliation': 'Department of Statistics, University of Pretoria, Pretoria, South Africa.'}, {'ForeName': 'Almari', 'Initials': 'A', 'LastName': 'Conradie', 'Affiliation': 'TB Alliance, Pretoria, South Africa.'}, {'ForeName': 'Angela M', 'Initials': 'AM', 'LastName': 'Crook', 'Affiliation': 'MRC Clinical Trials Unit at UCL, London, UK.'}, {'ForeName': 'Carl M', 'Initials': 'CM', 'LastName': 'Mendel', 'Affiliation': 'Global Alliance for TB Drug Development, New York, NY, USA.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Conradie', 'Affiliation': 'Clinical HIV Research Unit, University of Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Andreas H', 'Initials': 'AH', 'LastName': 'Diacon', 'Affiliation': 'TASK Applied Science, Bellville, South Africa; Division of Physiology, Department of Medical Biochemistry, Stellenbosch University, Tygerberg, South Africa.'}, {'ForeName': 'Nyanda E', 'Initials': 'NE', 'LastName': 'Ntinginya', 'Affiliation': 'NIMR-Mbeya Medical Research Centre, Mbeya, Tanzania.'}, {'ForeName': 'Daniel E', 'Initials': 'DE', 'LastName': 'Everitt', 'Affiliation': 'Global Alliance for TB Drug Development, New York, NY, USA.'}, {'ForeName': 'Frederick', 'Initials': 'F', 'LastName': 'Haraka', 'Affiliation': 'Ifakara Health Institute Bagamoyo Research and Training Center, Bagamoyo, Tanzania.'}, {'ForeName': 'Mengchun', 'Initials': 'M', 'LastName': 'Li', 'Affiliation': 'Global Alliance for TB Drug Development, New York, NY, USA.'}, {'ForeName': 'Christo H', 'Initials': 'CH', 'LastName': 'van Niekerk', 'Affiliation': 'TB Alliance, Pretoria, South Africa.'}, {'ForeName': 'Alphonse', 'Initials': 'A', 'LastName': 'Okwera', 'Affiliation': 'Uganda Case Western Reserve University Research Collaboration, Kampala, Uganda.'}, {'ForeName': 'Mohammed S', 'Initials': 'MS', 'LastName': 'Rassool', 'Affiliation': 'Clinical HIV Research Unit, Helen Joseph Hospital, Johannesburg, South Africa.'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Reither', 'Affiliation': 'Ifakara Health Institute Bagamoyo Research and Training Center, Bagamoyo, Tanzania; Swiss Tropical and Public Health Institute, Basel, Switzerland.'}, {'ForeName': 'Modulakgotla A', 'Initials': 'MA', 'LastName': 'Sebe', 'Affiliation': 'The Aurum Institute, Tembisa Hospital, Tembisa, South Africa.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Staples', 'Affiliation': 'THINK, Durban, South Africa.'}, {'ForeName': 'Ebrahim', 'Initials': 'E', 'LastName': 'Variava', 'Affiliation': 'MDR Unit, Klerksdorp Tshepong Hospital, Klerksdorp, South Africa.'}, {'ForeName': 'Melvin', 'Initials': 'M', 'LastName': 'Spigelman', 'Affiliation': 'Global Alliance for TB Drug Development, New York, NY, USA.'}]",The Lancet. Respiratory medicine,['10.1016/S2213-2600(19)30366-2'] 1069,31407311,"Laboratory safety of dupilumab in moderate-to-severe atopic dermatitis: results from three phase III trials (LIBERTY AD SOLO 1, LIBERTY AD SOLO 2, LIBERTY AD CHRONOS).","BACKGROUND Dupilumab [a monoclonal antibody blocking the shared receptor subunit for interleukin (IL)-4 and IL-13] is approved for patients aged ≥ 12 years with inadequately controlled, moderate-to-severe atopic dermatitis (AD). Dupilumab trials of up to 52 weeks demonstrated efficacy and a favourable safety profile in patients with moderate-to-severe AD inadequately controlled with topical medications. OBJECTIVES To further characterize the safety of dupilumab by evaluating clinical laboratory findings from three randomized, double-blinded, placebo-controlled phase III trials (LIBERTY AD SOLO 1 & 2 and LIBERTY AD CHRONOS). METHODS Patients were randomized 1 : 1 : 1 (SOLO 1 & 2) or 3 : 1 : 3 (CHRONOS) for 16 and 52 weeks, respectively, to dupilumab weekly, every 2 weeks or placebo. CHRONOS patients received a standardized concomitant topical corticosteroid regimen. Laboratory outcomes were summarized descriptively in 1376 patients from SOLO 1 & 2 and 740 from CHRONOS. RESULTS Treatment groups had similar results in baseline laboratory parameters. Platelets and neutrophils showed mild decreases from baseline in dupilumab vs. placebo groups. Some dupilumab-treated patients had small transient increases in eosinophils. Grade 3 eosinophilia was reported in < 1% of dupilumab-treated and placebo-treated patients; no adverse events were associated with eosinophilia. Lactate dehydrogenase levels decreased from baseline during dupilumab treatment in all trials. No clinically meaningful changes were observed between treatment groups in other haematology, chemistry or urinalysis parameters. CONCLUSIONS There were no clinically important changes in routine laboratory parameters that could be attributed to dupilumab. This study supports the use of dupilumab as a systemic treatment for moderate-to-severe AD that does not require laboratory monitoring. What's already known about this topic? Long-term treatment of atopic dermatitis (AD) with conventional immunosuppressive agents is limited by the risk of significant side-effects and a need for repeated tests to monitor haematological and/or organ (e.g. liver, kidney) toxicities. Dupilumab [a monoclonal antibody blocking the shared receptor subunit for interleukin (IL)-4 and IL-13] is approved for the treatment of patients with inadequately controlled, moderate-to-severe AD. In 16-week and 52-week studies, dupilumab demonstrated a positive risk/benefit profile in moderate-to-severe AD. What does this study add? This study is the first comprehensive analysis of dupilumab laboratory safety data of the 16-week SOLO 1 & 2 (pooled N = 1376) and 52-week CHRONOS (N = 740) trials, demonstrating an absence of clinically important changes in haematology, serum chemistry and urinalysis parameters in patients with moderate-to-severe AD treated with dupilumab. Our data support the use of dupilumab as a systemic treatment for the long-term management of moderate-to-severe AD without routine laboratory monitoring in clinical practice.",2020,"No clinically meaningful changes were observed between treatment groups in other haematology, chemistry or urinalysis parameters. ","['Patients', 'moderate-to-severe atopic dermatitis', '1376 patients from SOLO 1 & 2 and 740 from CHRONOS', 'moderate-to-severe AD', 'patients aged ≥12 years with inadequately controlled, moderate-to-severe atopic dermatitis (AD', 'patients with moderate-to-severe AD inadequately controlled with topical medications']","['placebo', 'dupilumab']","['Grade 3 eosinophilia', 'eosinophils', 'adverse events', 'Lactate dehydrogenase levels']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0011615', 'cui_str': 'Neurodermatitis, Disseminated'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3660996', 'cui_str': 'dupilumab'}]","[{'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C2240374', 'cui_str': 'Eosinophil count raised (finding)'}, {'cui': 'C0014467', 'cui_str': 'Eosinophil, segmented (cell)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0202113', 'cui_str': 'Lactate dehydrogenase measurement (procedure)'}]",1376.0,0.342166,"No clinically meaningful changes were observed between treatment groups in other haematology, chemistry or urinalysis parameters. ","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Wollenberg', 'Affiliation': 'Department of Dermatology and Allergology, Ludwig Maximilian University of Munich, Frauenlobstraße 9-11, 80337, Munich, Germany.'}, {'ForeName': 'L A', 'Initials': 'LA', 'LastName': 'Beck', 'Affiliation': 'Department of Dermatology, University of Rochester Medical Center, Rochester, NY, U.S.A.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Blauvelt', 'Affiliation': 'Oregon Medical Research Center, Portland, OR, U.S.A.'}, {'ForeName': 'E L', 'Initials': 'EL', 'LastName': 'Simpson', 'Affiliation': 'Department of Dermatology, Oregon Health & Science University, Portland, OR, U.S.A.'}, {'ForeName': 'Z', 'Initials': 'Z', 'LastName': 'Chen', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, NY, U.S.A.'}, {'ForeName': 'Q', 'Initials': 'Q', 'LastName': 'Chen', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, NY, U.S.A.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Shumel', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, NY, U.S.A.'}, {'ForeName': 'F A', 'Initials': 'FA', 'LastName': 'Khokhar', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, NY, U.S.A.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Hultsch', 'Affiliation': 'Sanofi Genzyme, Cambridge, MA, U.S.A.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Rizova', 'Affiliation': 'Sanofi Genzyme, Cambridge, MA, U.S.A.'}, {'ForeName': 'A B', 'Initials': 'AB', 'LastName': 'Rossi', 'Affiliation': 'Sanofi Genzyme, Cambridge, MA, U.S.A.'}, {'ForeName': 'N M H', 'Initials': 'NMH', 'LastName': 'Graham', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, NY, U.S.A.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Pirozzi', 'Affiliation': 'Sanofi, Bridgewater, NJ, U.S.A.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Lu', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, NY, U.S.A.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Ardeleanu', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., Tarrytown, NY, U.S.A.'}]",The British journal of dermatology,['10.1111/bjd.18434'] 1070,31733764,"Neural gliding versus neural tensioning: Effects on heat and cold thresholds, pain thresholds and hand grip strength in asymptomatic individuals.","INTRODUCTION Neural mobilization can be performed in a way that facilitates movement through a stretching technique (tensioning) or in a way that maximizes the gliding of peripheral nerves in relation to adjacent structures (gliding). Evidence on how these techniques compare in terms of effects are scarce. The aim of this study is to compare the effects of neural gliding and neural tensioning targeting the median nerve on heat and cold temperature threshold, heat pain threshold, pressure pain thresholds and hand grip strength in asymptomatic participants. METHODS Participants received 4 series of 10 repetitions of either neural gliding (n = 30) or neural tensioning (n = 30) and were assessed for heat and cold temperature threshold, heat pain threshold, pressure pain threshold, and hand grip strength at baseline, immediately after the intervention, and 30 min post-intervention. RESULTS A significant main interaction between time and intervention was found for the PPT at the forearm (F(2,55) = 5.98; p = 0.004), favouring the tensioning neural mobilization. No significant differences were found for the other variables. CONCLUSIONS Four series of 10 repetitions of neural tensioning targeting the median nerve in asymptomatic subjects seem to be enough to induce hypoalgesia and have no negative effects on A-delta and C mediated sensory function and on hand grip strength production.",2019,"A significant main interaction between time and intervention was found for the PPT at the forearm (F(2,55) ","['asymptomatic participants', 'asymptomatic individuals', 'Participants received 4 series of 10 repetitions of either']","['Neural gliding versus neural tensioning', 'neural gliding (n\u202f=\u202f30) or neural tensioning (n\u202f=\u202f30) and were assessed for heat and cold temperature threshold, heat pain threshold, pressure pain threshold, and hand grip strength at baseline, immediately after the intervention, and 30\u202fmin post-intervention', 'neural gliding and neural tensioning']","['heat and cold thresholds, pain thresholds and hand grip strength']","[{'cui': 'C0231221', 'cui_str': 'Asymptomatic (finding)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0205549', 'cui_str': 'Series (qualifier value)'}, {'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}]","[{'cui': 'C0336966', 'cui_str': 'Gliding'}, {'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C0009264', 'cui_str': 'Cold'}, {'cui': 'C0449864', 'cui_str': 'Threshold (property) (qualifier value)'}, {'cui': 'C0162703', 'cui_str': 'Pain Threshold'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C1293900', 'cui_str': 'Hand grip'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}]","[{'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C0009443', 'cui_str': 'Common Cold'}, {'cui': 'C0449864', 'cui_str': 'Threshold (property) (qualifier value)'}, {'cui': 'C0162703', 'cui_str': 'Pain Threshold'}, {'cui': 'C1293900', 'cui_str': 'Hand grip'}]",,0.0389521,"A significant main interaction between time and intervention was found for the PPT at the forearm (F(2,55) ","[{'ForeName': 'Tiago', 'Initials': 'T', 'LastName': 'Gamelas', 'Affiliation': 'School of Health Sciences, University of Aveiro, Campus Universitário de Santiago, 3810-193, Aveiro, Portugal.'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Fernandes', 'Affiliation': 'School of Health Sciences, University of Aveiro, Campus Universitário de Santiago, 3810-193, Aveiro, Portugal.'}, {'ForeName': 'Ivo', 'Initials': 'I', 'LastName': 'Magalhães', 'Affiliation': 'School of Health Sciences, University of Aveiro, Campus Universitário de Santiago, 3810-193, Aveiro, Portugal.'}, {'ForeName': 'Mário', 'Initials': 'M', 'LastName': 'Ferreira', 'Affiliation': 'School of Health Sciences, University of Aveiro, Campus Universitário de Santiago, 3810-193, Aveiro, Portugal.'}, {'ForeName': 'Solange', 'Initials': 'S', 'LastName': 'Machado', 'Affiliation': 'School of Health Sciences, University of Aveiro, Campus Universitário de Santiago, 3810-193, Aveiro, Portugal.'}, {'ForeName': 'Anabela G', 'Initials': 'AG', 'LastName': 'Silva', 'Affiliation': 'School of Health Sciences, University of Aveiro, Campus Universitário de Santiago, 3810-193, Aveiro, Portugal; Center for Health Technology and Services Research (CINTESIS.UA), University of Aveiro, Campus Universitário de Santiago, 3810-193, Aveiro, Portugal. Electronic address: asilva@ua.pt.'}]",Journal of bodywork and movement therapies,['10.1016/j.jbmt.2019.04.011'] 1071,31733777,Efficacy of core exercises in patients with osteoarthritis of the knee: A randomized controlled clinical trial.,"TRIAL DESIGN Randomized, evaluator blinded, controlled, parallel group. METHODS This trial was conducted between July 2011 and January 2015 at a public hospital in Argentina. Patients older than 40 years with a medical diagnosis of osteoarthritis (OA) were randomly assigned to the experimental group (EG) or control group (CG). Both groups performed conventional exercises 3 times a week for 12 weeks and core exercises were added to the EG intervention. The objective was to compare the efficacy of conventional treatment combined with core muscle strengthening exercises, with conventional treatment alone in terms of short- and medium-term pain reduction and physical function in patients with knee OA. The primary outcome was knee pain assessed using a visual analog scale and the secondary outcome was physical function assessed at baseline, week 8 and 12, and 2 follow-up visits held 1 month and 3 months after the end of treatment. RESULTS 113 patients were randomized to a CG (n = 60) or EG (n = 53). 66 patients were eliminated and 25 patients in the EG and 22 in the CG were analyzed. Both pain reduction and improved physical function were observed throughout the intervention in both groups. At the end of the treatment, a statistically and clinically significant pain reduction was observed in the EG. No adverse effects were reported. CONCLUSION The combination of core muscle activation exercises and conventional treatment was more effective in short-term pain reduction in patients with knee OA.",2019,The combination of core muscle activation exercises and conventional treatment was more effective in short-term pain reduction in patients with knee OA.,"['66 patients were eliminated and 25 patients in the EG and 22 in the CG were analyzed', 'July 2011 and January 2015\u202fat a public hospital in Argentina', 'Patients older than 40 years with a medical diagnosis of osteoarthritis (OA', '113 patients', 'patients with osteoarthritis of the knee', 'patients with knee OA']","['conventional treatment combined with core muscle strengthening exercises', 'control group (CG', 'core exercises', 'CG', 'core muscle activation exercises and conventional treatment']","['knee pain assessed using a visual analog scale', 'adverse effects', 'pain reduction and improved physical function', 'pain reduction']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0644188', 'cui_str': 'CG-AM'}, {'cui': 'C0020022', 'cui_str': 'Hospitals, Public'}, {'cui': 'C0003761', 'cui_str': 'Argentina'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0029408', 'cui_str': 'Arthritis, Degenerative'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0444669', 'cui_str': 'Core (qualifier value)'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0231749', 'cui_str': 'Knee pain (finding)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}]",113.0,0.0490521,The combination of core muscle activation exercises and conventional treatment was more effective in short-term pain reduction in patients with knee OA.,"[{'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Hernandez', 'Affiliation': 'Physical Therapy Service of Hospital Durand, Buenos Aires, Argentina. Electronic address: danifhernandez@hotmail.com.'}, {'ForeName': 'Mariana', 'Initials': 'M', 'LastName': 'Dimaro', 'Affiliation': 'Physical Therapy Service of Hospital Durand, Buenos Aires, Argentina.'}, {'ForeName': 'Emliano', 'Initials': 'E', 'LastName': 'Navarro', 'Affiliation': 'Physical Therapy Service of Hospital Durand, Buenos Aires, Argentina.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Dorado', 'Affiliation': 'Physical Therapy Service of Hospital Durand, Buenos Aires, Argentina.'}, {'ForeName': 'Matías', 'Initials': 'M', 'LastName': 'Accoce', 'Affiliation': 'Physical Therapist of Sanatorio Anchorena San Martín, Argentina.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Salzberg', 'Affiliation': 'Physical Therapy Service of Hospital Durand, Buenos Aires, Argentina.'}, {'ForeName': 'Pablo Oscar', 'Initials': 'PO', 'LastName': 'Policastro', 'Affiliation': 'Physical Therapy Service of Hospital Durand, Buenos Aires, Argentina.'}]",Journal of bodywork and movement therapies,['10.1016/j.jbmt.2019.06.002'] 1072,31067587,Do Individual Differences in Physical Therapists' Skills Affect Postoperative Results of Total Knee Arthroplasty?,"We investigated variations in postoperative outcomes of total knee arthroplasty which were dependent on the physical therapist (PT) who performed rehabilitation while keeping other parameters as uniform as possible. Seventy-nine among 690 knees were selected based on strict inclusion and exclusion criteria. Patients were randomly assigned to five PTs, who had from 2 to 21 years of experience. Range of motion (ROM) on postoperative days (PODs) 1, 3, 7, and 14 and at postoperative months 3, 6, and 12, results of timed up and go (TUG) test on POD 14, time to walking with a single cane, and time to climbing stairs, were evaluated. There were significant differences until POD 3, and no significant differences afterward in flexion. There was a significant difference on POD 1 only in extension. The TUG test showed no significant difference, but there were significant differences at the time of walking with a single cane and climbing stairs. The time taken to achieve rehabilitation, which was determined subjectively by each PT, differed among therapists, but differences in ROM were present in early period. Therefore, ROM after surgery is not affected by differences between PTs.",2020,"The TUG test showed no significant difference, but there were significant differences at the time of walking with a single cane and climbing stairs.",['Seventy-nine among 690 knees were selected based on strict inclusion and exclusion criteria'],[],"['time of walking with a single cane and climbing stairs', 'POD', 'timed up and go (TUG) test on POD 14, time to walking with a single cane, and time to climbing stairs']","[{'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]",[],"[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0006856', 'cui_str': 'Walking Sticks'}, {'cui': 'C1290942', 'cui_str': 'Stair Navigation'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}]",690.0,0.033603,"The TUG test showed no significant difference, but there were significant differences at the time of walking with a single cane and climbing stairs.","[{'ForeName': 'Tadashi', 'Initials': 'T', 'LastName': 'Fujii', 'Affiliation': 'Department of Orthopaedic Surgery, Kashiba Asahigaoka Hospital, Kashiba, Nara, Japan.'}, {'ForeName': 'Naoyuki', 'Initials': 'N', 'LastName': 'Nishio', 'Affiliation': 'Department of Rehabilitation, Kashiba Asahigaoka Hospital, Kashiba, Nara, Japan.'}, {'ForeName': 'Minenari', 'Initials': 'M', 'LastName': 'Bandou', 'Affiliation': 'Department of Rehabilitation, Kashiba Asahigaoka Hospital, Kashiba, Nara, Japan.'}, {'ForeName': 'Shuji', 'Initials': 'S', 'LastName': 'Kitano', 'Affiliation': 'Department of Orthopaedic Surgery, Saiseikai Tondabayashi Hospital, Tondabayashi, Osaka, Japan.'}, {'ForeName': 'Marehoshi', 'Initials': 'M', 'LastName': 'Noboru', 'Affiliation': 'Department of Orthopaedic Surgery, Kashiba Asahigaoka Hospital, Kashiba, Nara, Japan.'}, {'ForeName': 'Munehito', 'Initials': 'M', 'LastName': 'Seko', 'Affiliation': 'Department of Orthopaedic Surgery, Kashiba Asahigaoka Hospital, Kashiba, Nara, Japan.'}, {'ForeName': 'Yusuke', 'Initials': 'Y', 'LastName': 'Inagaki', 'Affiliation': 'Department of Orthopaedic Surgery, Nara Medical University, Kashiba, Nara, Japan.'}, {'ForeName': 'Yasuhito', 'Initials': 'Y', 'LastName': 'Tanaka', 'Affiliation': 'Department of Orthopaedic Surgery, Nara Medical University, Kashiba, Nara, Japan.'}]",The journal of knee surgery,['10.1055/s-0039-1688690'] 1073,30927417,Medroxyprogesterone acetate versus ganirelix in oocyte donation: a randomized controlled trial.,"STUDY QUESTION Is oral medroxiprogesterone acetate (MPA) non-inferior compared to ganirelix with respect to the number of mature oocytes (MII) retrieved at ovum pick-up (OPU) in oocyte donation cycles? SUMMARY ANSWER MPA is comparable to ganirelix in terms of number of MII retrieved at OPU in oocyte donation cycles. WHAT IS KNOWN ALREADY Oral treatment with MPA inhibits the pituitary LH surge during ovarian stimulation in infertile patients. Because of its negative effect on the endometrium, MPA suppression is combined with freeze-all. Published reports indicate that both the number of MII retrieved and pregnancy rates from these oocytes are comparable to short protocol of GnRH agonists during IVF cycles with freeze-all. MPA might allow for more comfortable and cost-effective ovarian stimulation. STUDY DESIGN, SIZE, DURATION Randomized clinical trial, open-label, single center, to assess the non-inferiority of MPA (10 mg/day) versus ganirelix (0.25 mg/day) from Day 7, in ovarian stimulation cycles triggered with triptoreline acetate. Trigger criterion was ≥3 follicles of diameter >18 mm. PARTICIPANTS/MATERIALS, SETTING, METHODS Overall, 252 oocyte donors were selected (eligible), 216 were randomized and 173 reached OPU: 86 under MPA and 87 under ganirelix. The main outcome was the number of MII retrieved at OPU. Secondary outcomes were embryological laboratory outcomes and reproductive outcomes in recipients. The study was powered to test that the lower limit of the 95% confidence interval of the difference in retrieved MII between groups will be above the non-inferiority limit of -3. Differences were tested using a two-sided Student's t-test or a Pearson's Chi2 test, as appropriate. MAIN RESULTS AND THE ROLE OF CHANCE All participants were in their first cycle of oocyte donation. On average, donors were 24 (SD 4.5) years old and with a BMI of 23 (SD 2.9) kg/m2. Duration of stimulation was similar in both groups (11.2 days), as well as the total gonadotropin dose up to trigger (2162 IU in MPA and 2163 IU in ganirelix). The number of MII retrieved was no different: 15.1 (SD 8.3) with MPA and 14.6 (SD 7.0), 95% CI of the difference -2.78, -1.83 excluding the pre-defined non-inferiority limit (-3). Recipients and embryo transfer (ET) characteristics were also similar between groups. The average age of recipients was 42 (SD 4.8) years and the BMI was 24 (SD 4.4) kg/m2. The mean number of MII assigned to each recipients was 6.7 (SD 1.2) in MPA and 6.6 (SD 1.2) in ganirelix (P = 0.58). MII were fertilized with partner sperm in 84% cycles overall and fertilization rate was 76% in MPA versus 74% in ganirelix (P = 0.34). Overall, there was 54% of double ET and 46% of single ET, with 40% of ETs were performed in D5. In spite of similar recipients and cycle characteristics, reproductive outcomes were unexpectedly lower with MPA. Biochemical pregnancy rate was 44 versus 57% (P = 0.023); clinical pregnancy rate 31 versus 46% (P = 0.006); ongoing pregnancy rate 27 versus 40%, (P = 0.015) and live birth rate 22 versus 31%, (P = 0.10). LIMITATIONS, REASONS FOR CAUTION Although oocyte recipient and ET characteristics are similar among groups, this RCT has been designed under a hypothesis of non-inferiority in the number of MII obtained and recipients were not randomized; therefore, the reproductive outcomes in recipients should be evaluated with extreme caution. WIDER IMPLICATION OF THE FINDINGS Ovarian stimulation using MPA for prevention of LH surge yields comparable number of MII oocytes compared to ganirelix in oocyte donation cycles. The unexpected finding in reproductive outcomes should be further investigated. STUDY FUNDING/COMPETING INTEREST(S) None to report. TRIAL REGISTRATION NUMBER EudraCT number: 2015-004328-73; ClinicalTrials.gov Identifier: NCT02796105. TRIAL REGISTRATION DATE 29 September 2015 (EudraCT); 9 June 2016 (ClinicalTrials.gov). DATE OF FIRST PATIENT’S ENROLLMENT The date of enrollment of the first participant was 07 July 2016, and the last participant last visit in the study was on 10 July 2017.",2019,"Biochemical pregnancy rate was 44 versus 57% (P = 0.023); clinical pregnancy rate 31 versus 46% (P = 0.006); ongoing pregnancy rate 27 versus 40%, (P = 0.015) and live birth rate 22 versus 31%, (P = 0.10). ","['29 September 2015 (EudraCT); 9 June 2016 (ClinicalTrials.gov', '’S', 'average age of recipients was 42 (SD 4.8) years and the BMI was 24 (SD 4.4) kg/m2', 'oocyte donation', 'On average, donors were 24 (SD 4.5) years old and with a BMI of 23 (SD 2.9) kg/m2', 'first participant was 07 July 2016, and the last participant last visit in the study was on 10 July 2017', 'infertile patients', 'Overall, 252 oocyte donors were selected (eligible), 216 were randomized and 173 reached OPU: 86 under MPA and 87 under ganirelix']","['Medroxyprogesterone acetate versus ganirelix', 'ganirelix', 'triptoreline acetate', 'medroxiprogesterone acetate (MPA', 'MPA']","['fertilization rate', 'embryological laboratory outcomes and reproductive outcomes', 'Biochemical pregnancy rate', 'Duration of stimulation', 'mean number of MII', 'live birth rate', 'number of MII retrieved at OPU', 'clinical pregnancy rate', 'ongoing pregnancy rate', 'number of MII', 'embryo transfer (ET) characteristics']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517765', 'cui_str': '4.8 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517761', 'cui_str': '4.4'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C0242813', 'cui_str': 'Oocyte Donation'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C3844009', 'cui_str': 'Four point five'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C4517641', 'cui_str': '2.9 (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0021359', 'cui_str': 'Infertility'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C3267027', 'cui_str': 'Oocyte donor'}, {'cui': 'C4708905', 'cui_str': 'Two hundred and sixteen'}, {'cui': 'C0596012', 'cui_str': 'Does reach (finding)'}, {'cui': 'C0073629', 'cui_str': 'ganirelix'}]","[{'cui': 'C0065864', 'cui_str': 'medroxyprogesterone acetate'}, {'cui': 'C0073629', 'cui_str': 'ganirelix'}, {'cui': 'C0000975', 'cui_str': 'Acetate'}]","[{'cui': 'C0015914', 'cui_str': 'Fertilization'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0404845', 'cui_str': 'Biochemical pregnancy (finding)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0481667', 'cui_str': 'Live Birth'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rate'}, {'cui': 'C0013938', 'cui_str': 'Embryo Transfer'}]",,0.331495,"Biochemical pregnancy rate was 44 versus 57% (P = 0.023); clinical pregnancy rate 31 versus 46% (P = 0.006); ongoing pregnancy rate 27 versus 40%, (P = 0.015) and live birth rate 22 versus 31%, (P = 0.10). ","[{'ForeName': 'R', 'Initials': 'R', 'LastName': 'Beguería', 'Affiliation': 'Clínica EUGIN, Travessera de les Corts 322, Barcelona, Spain.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'García', 'Affiliation': 'Clínica EUGIN, Travessera de les Corts 322, Barcelona, Spain.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Vassena', 'Affiliation': 'Clínica EUGIN, Travessera de les Corts 322, Barcelona, Spain.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Rodríguez', 'Affiliation': 'Clínica EUGIN, Travessera de les Corts 322, Barcelona, Spain.'}]","Human reproduction (Oxford, England)",['10.1093/humrep/dez034'] 1074,31063870,Rationale and design for a pragmatic effectiveness-implementation trial of online behavioral obesity treatment in primary care.,"BACKGROUND Current guidelines recommend behavioral intervention to achieve a modest weight loss (e.g., 3-5%) as a first-line obesity treatment. Online behavioral obesity treatment, delivered via the Rx Weight Loss (RxWL) program, produces clinically significant initial weight losses. However, the program's pragmatic utility in routine medical care has yet to be tested. Further, additional research is needed to determine how best to extend the RxWL program to facilitate weight loss maintenance. This paper summarizes methods for a pragmatic trial aimed at identifying optimal methods for implementation of RxWL in primary care and evaluating relative effectiveness of two approaches to weight loss maintenance. STUDY DESIGN RxWL will be implemented in a network of approximately 60 primary care clinics. Implementation outcomes (program uptake and completion metrics) will be compared between a Basic Implementation Intervention consisting primarily of access to RxWL, and an Enhanced Implementation Intervention with additional training in strategies for motivating and supporting patients in their use of RxWL and online clinician support tools for tracking patient progress. Second, two intervention approaches (Monthly Lessons versus Refresher Courses) within the RxWL patient platform will be tested against an educational control condition, and effects on 1-year weight loss maintenance will be compared. CONCLUSION This study will provide essential information about the feasibility and utility of online obesity treatment in primary care. It will provide novel information on two approaches to weight loss maintenance for patients in this setting. This project fills key gaps in evidence regarding best practices for obesity treatment in primary care.",2019,"Online behavioral obesity treatment, delivered via the Rx Weight Loss (RxWL) program, produces clinically significant initial weight losses.","['primary care', 'approximately 60 primary care clinics']","['online behavioral obesity treatment', 'Online behavioral obesity treatment, delivered via the Rx Weight Loss (RxWL) program']","['weight loss maintenance', 'weight loss', '1-year weight loss maintenance']","[{'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0332232', 'cui_str': 'Approximate (qualifier value)'}, {'cui': 'C1552443', 'cui_str': 'Primary care clinic (environment)'}]","[{'cui': 'C4706528', 'cui_str': 'Obesity care'}, {'cui': 'C3179079', 'cui_str': 'Weight Loss Programs'}]","[{'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]",,0.0479472,"Online behavioral obesity treatment, delivered via the Rx Weight Loss (RxWL) program, produces clinically significant initial weight losses.","[{'ForeName': 'Hallie M', 'Initials': 'HM', 'LastName': 'Espel-Huynh', 'Affiliation': 'Weight Control and Diabetes Research Center, The Miriam Hospital, 196 Richmond St., Providence, RI 02903, USA; Department of Psychiatry and Human Behavior, Alpert Medical School of Brown University, 222 Richmond St., Providence, RI 02903, USA. Electronic address: hallie_espel-huynh@brown.edu.'}, {'ForeName': 'Rena R', 'Initials': 'RR', 'LastName': 'Wing', 'Affiliation': 'Weight Control and Diabetes Research Center, The Miriam Hospital, 196 Richmond St., Providence, RI 02903, USA; Department of Psychiatry and Human Behavior, Alpert Medical School of Brown University, 222 Richmond St., Providence, RI 02903, USA.'}, {'ForeName': 'Carly M', 'Initials': 'CM', 'LastName': 'Goldstein', 'Affiliation': 'Weight Control and Diabetes Research Center, The Miriam Hospital, 196 Richmond St., Providence, RI 02903, USA; Department of Psychiatry and Human Behavior, Alpert Medical School of Brown University, 222 Richmond St., Providence, RI 02903, USA.'}, {'ForeName': 'J Graham', 'Initials': 'JG', 'LastName': 'Thomas', 'Affiliation': 'Weight Control and Diabetes Research Center, The Miriam Hospital, 196 Richmond St., Providence, RI 02903, USA; Department of Psychiatry and Human Behavior, Alpert Medical School of Brown University, 222 Richmond St., Providence, RI 02903, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2019.05.003'] 1075,31067329,Efficacy and safety of ASP1707 for endometriosis-associated pelvic pain: the phase II randomized controlled TERRA study.,"STUDY QUESTION Does the GnRH antagonist, ASP1707, reduce endometriosis-associated pelvic pain? SUMMARY ANSWER ASP1707 significantly reduced endometriosis-associated pelvic pain in a dose-related manner. WHAT IS KNOWN ALREADY GnRH agonists are an effective therapeutic option for endometriosis that is refractory to non-steroidal anti-inflammatory drugs, oral contraceptives, and progestins. However, GnRH agonists cause complete suppression of estradiol (E2), resulting in hypoestrogenic side-effects such as bone loss that may increase the future risk of osteoporotic fractures. STUDY DESIGN, SIZE, DURATION This was a Phase II, multicenter, double-blind, randomized, parallel-group, placebo-controlled study conducted in 540 women from 04 December 2012 to 30 July 2015 in Europe and Japan. A sample size of 504 (84 subjects per group) was calculated to provide ≥80% power to detect a dose-related treatment effect among placebo and ASP1707 doses in change from baseline in pelvic pain, assuming different dose-response curves after 12 weeks of treatment. PARTICIPANTS/MATERIALS, SETTING, METHODS Of 912 women with endometriosis-associated pelvic pain screened, 540 were enrolled, and 532 received ≥1 dose of study drug (placebo, n = 88; ASP1707 3 mg, n = 86; ASP1707 5 mg, n = 91; ASP1707 10 mg, n = 90; ASP1707 15 mg, n = 88; leuprorelin, n = 89) for 24 weeks. MAIN RESULTS AND THE ROLE OF CHANCE After 12 weeks of treatment with ASP1707, the mean (95% CI) changes in numeric rating score (NRS) for overall pelvic pain (OPP) were -1.56 (-1.91, -1.21), -1.63 (-1.99, -1.27), -1.93 (-2.27, -1.60), -2.29 (-2.64, -1.94), and -2.13 (-2.47, -1.79) for placebo, ASP1707 3 mg, ASP1707 5 mg, ASP1707 10 mg, and ASP1707 15 mg, respectively. Mean (95% CI) changes in NRS for dysmenorrhea were -1.50 (-2.00, -1.00), -2.72 (-3.22, -2.21), -2.85 (-3.33, -2.38), -3.97 (-4.46, -3.48), and -4.18 (-4.66, -3.70), respectively. Mean (95% CI) changes in NRS for non-menstrual pelvic pain (NMPP) were -1.53 (-1.88, -1.19), -1.51 (-1.87, -1.16), -1.80 (-2.14, -1.47), -2.03 (-2.37, -1.68), and -1.86 (-2.20, -1.52), respectively. Statistically significant dose-related treatment effects in reduction in NRS for OPP (P = 0.001), dysmenorrhea (P < 0.001), and NMPP (P = 0.029) were observed after 12 weeks among ASP1707 doses and were maintained through 24 weeks. Serum estradiol and bone mineral density decreased dose dependently with ASP1707 through 24 weeks, however, to a lesser extent than with leuprorelin. LIMITATIONS, REASON FOR CAUTION This study was not powered for pairwise comparison of each ASP1707 group versus placebo. WIDER IMPLICATIONS OF THE FINDINGS All doses of ASP1707 reduced serum E2 levels to within the target range and to a lesser extent than leuprorelin. ASP1707 is a potential alternative treatment to leuprorelin for endometriosis-associated pelvic pain with lower impact on bone health. STUDY FUNDING/COMPETING INTEREST(S) This study was funded by Astellas Pharma Inc. T.D'.H is Vice President and Head of Global Medical Affairs Fertility at Merck, Darmstadt, Germany since October 1, 2015. At the time that the TERRA study was conducted, he served as Principal Investigator in his role as Coordinator of the Leuven University Fertility Center. Since October 2015, T.D'.H has left Leuven University Hospital Gasthuisberg, but continues to serve as Professor in Reproductive Medicine and Biology at KU Leuven (University of Leuven) Belgium and at the Dept of Obstetrics, Gynecology and Reproduction at Yale University, New Haven, USA. T. Fukaya and Y. Osuga report personal consulting fees from Astellas Pharma Inc. during the conduct of the study and outside the submitted work. G.M. Holtkamp, and L. Skillern are employed by Astellas Pharma Europe B.V.; K. Miyazaki is employed by Astellas Pharma Inc.; B. López, was a biostatistician for Astellas Pharma Europe B.V. during conduct of the study; R. Besuyen was a contract Associate Director of Medical Science for Astellas during conduct of the study. TRIAL REGISTRATION NUMBER ClinicalTrials.gov, www.clinicaltrials.gov, NCT01767090. EudraCT number 2012-002791-14. TRIAL REGISTRATION DATE 18 December 2012. DATE OF FIRST SUBJECT’S ENROLLMENT One subject signed informed consent on 04 December 2012; the first subject was randomized on 16 April 2013.",2019,"Statistically significant dose-related treatment effects in reduction in NRS for OPP (P = 0.001), dysmenorrhea (P < 0.001), and NMPP (P = 0.029) were observed after 12 weeks among ASP1707 doses and were maintained through 24 weeks.","['18 December 2012', '540 women from 04 December 2012 to 30 July 2015 in Europe and Japan', 'endometriosis-associated pelvic pain', 'Of 912 women with endometriosis-associated pelvic pain screened, 540 were enrolled, and 532 received ≥1 dose of study drug (placebo, n = 88']","['GnRH agonists', 'placebo', 'placebo, ASP1707', 'ASP1707', 'placebo and ASP1707']","['NRS for dysmenorrhea', 'numeric rating score (NRS) for overall pelvic pain (OPP', 'dysmenorrhea', 'serum E2 levels', 'NRS for non-menstrual pelvic pain (NMPP', 'Efficacy and safety', 'Serum estradiol and bone mineral density', 'endometriosis-associated pelvic pain', 'NMPP']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0014175', 'cui_str': 'Endometriosis'}, {'cui': 'C0030794', 'cui_str': 'Pelvic Pain'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0023610', 'cui_str': 'Gonadorelin'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0013390', 'cui_str': 'Pain, Menstrual'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0030794', 'cui_str': 'Pelvic Pain'}, {'cui': 'C0911329', 'cui_str': 'OPP'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0474672', 'cui_str': 'Serum estradiol measurement'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0014175', 'cui_str': 'Endometriosis'}]",540.0,0.225805,"Statistically significant dose-related treatment effects in reduction in NRS for OPP (P = 0.001), dysmenorrhea (P < 0.001), and NMPP (P = 0.029) were observed after 12 weeks among ASP1707 doses and were maintained through 24 weeks.","[{'ForeName': 'Thomas', 'Initials': 'T', 'LastName': ""D'Hooghe"", 'Affiliation': 'Research Group Reproductive Medicine, Department of Development and Regeneration, Organ Systems, Group Biomedical Sciences, KU Leuven (University of Leuven), Belgium.'}, {'ForeName': 'Takao', 'Initials': 'T', 'LastName': 'Fukaya', 'Affiliation': 'Tohoku Medical and Pharmaceutical University, 4-4-1 Komatsushima, Aobaku, Sendai, Miyagi, Japan.'}, {'ForeName': 'Yutaka', 'Initials': 'Y', 'LastName': 'Osuga', 'Affiliation': 'The University of Tokyo, Graduate School of Medicine, 7-3-1, Hongo, Bunkyo, Tokyo, Japan.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Besuyen', 'Affiliation': 'Astellas Pharma Europe B.V., Sylviusweg 62, Leiden, the Netherlands.'}, {'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'López', 'Affiliation': 'Astellas Pharma Europe B.V., Sylviusweg 62, Leiden, the Netherlands.'}, {'ForeName': 'Gertjan M', 'Initials': 'GM', 'LastName': 'Holtkamp', 'Affiliation': 'Astellas Pharma Europe B.V., Sylviusweg 62, Leiden, the Netherlands.'}, {'ForeName': 'Kentaro', 'Initials': 'K', 'LastName': 'Miyazaki', 'Affiliation': 'Astellas Pharma Inc., 2-5-1, Nihonbashi-Honcho, Chuo-ku, Tokyo, Japan.'}, {'ForeName': 'Laurence', 'Initials': 'L', 'LastName': 'Skillern', 'Affiliation': 'Astellas Pharma Europe B.V., Sylviusweg 62, Leiden, the Netherlands.'}]","Human reproduction (Oxford, England)",['10.1093/humrep/dez028'] 1076,30218286,"The Effects of Probiotic Honey Consumption on Metabolic Status in Patients with Diabetic Nephropathy: a Randomized, Double-Blind, Controlled Trial.","To the best of our knowledge, this study is the first evaluating the effects of probiotic honey intake on glycemic control, lipid profiles, biomarkers of inflammation, and oxidative stress in patients with diabetic nephropathy (DN). This investigation was conducted to evaluate the effects of probiotic honey intake on metabolic status in patients with DN. This randomized, double-blind, controlled clinical trial was performed among 60 patients with DN. Patients were randomly allocated into two groups to receive either 25 g/day probiotic honey containing a viable and heat-resistant probiotic Bacillus coagulans T11 (IBRC-M10791) (10 8  CFU/g) or 25 g/day control honey (n = 30 each group) for 12 weeks. Fasting blood samples were taken at baseline and 12 weeks after supplementation to quantify glycemic status, lipid concentrations, biomarkers of inflammation, and oxidative stress. After 12 weeks of intervention, patients who received probiotic honey compared with the control honey had significantly decreased serum insulin levels (- 1.2 ± 1.8 vs. - 0.1 ± 1.3 μIU/mL, P = 0.004) and homeostasis model of assessment-estimated insulin resistance (- 0.5 ± 0.6 vs. 0.003 ± 0.4, P = 0.002) and significantly improved quantitative insulin sensitivity check index (+ 0.005 ± 0.009 vs. - 0.0007 ± 0.005, P = 0.004). Additionally, compared with the control honey, probiotic honey intake has resulted in a significant reduction in total-/HDL-cholesterol (- 0.2 ± 0.5 vs. + 0.1 ± 0.1, P = 0.04). Probiotic honey intake significantly reduced serum high-sensitivity C-reactive protein (hs-CRP) (- 1.9 ± 2.4 vs. - 0.2 ± 2.7 mg/L, P = 0.01) and plasma malondialdehyde (MDA) levels (- 0.1 ± 0.6 vs. + 0.6 ± 1.0 μmol/L, P = 0.002) compared with the control honey. Probiotic honey intake had no significant effects on other metabolic profiles compared with the control honey. Overall, findings from the current study demonstrated that probiotic honey consumption for 12 weeks among DN patients had beneficial effects on insulin metabolism, total-/HDL-cholesterol, serum hs-CRP, and plasma MDA levels, but did not affect other metabolic profiles. http://www.irct.ir: IRCT201705035623N115.",2019,"Probiotic honey intake significantly reduced serum high-sensitivity C-reactive protein (hs-CRP) (- 1.9 ± 2.4 vs. - 0.2 ± 2.7 mg/L, P = 0.01) and plasma malondialdehyde (MDA) levels (- 0.1 ± 0.6 vs. + 0.6 ± 1.0 μmol/L, P = 0.002) compared with the control honey.","['patients with diabetic nephropathy (DN', 'patients with DN', 'Patients with Diabetic Nephropathy', '60 patients with DN']","['Probiotic Honey Consumption', 'probiotic honey intake', '25\xa0g/day probiotic honey containing a viable and heat-resistant probiotic Bacillus coagulans T11']","['serum high-sensitivity C-reactive protein (hs-CRP', 'serum insulin levels', 'quantitative insulin sensitivity check index', 'homeostasis model of assessment-estimated insulin resistance', 'plasma malondialdehyde (MDA) levels', 'metabolic status', 'insulin metabolism, total-/HDL-cholesterol, serum hs-CRP, and plasma MDA levels', 'probiotic honey consumption', 'Fasting blood samples', 'Metabolic Status', 'metabolic profiles', 'glycemic control, lipid profiles, biomarkers of inflammation, and oxidative stress', 'glycemic status, lipid concentrations, biomarkers of inflammation, and oxidative stress', 'total-/HDL-cholesterol']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0011881', 'cui_str': 'Diabetic Nephropathy'}]","[{'cui': 'C0525033', 'cui_str': 'Probiotics'}, {'cui': 'C0019906', 'cui_str': 'Honey'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0456638', 'cui_str': '25G (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0443348', 'cui_str': 'Viable (qualifier value)'}, {'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C0332325', 'cui_str': 'Resistant (qualifier value)'}, {'cui': 'C0314879', 'cui_str': 'Lactobacillus sporogenes'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0428357', 'cui_str': 'Serum insulin measurement'}, {'cui': 'C0392762', 'cui_str': 'Quantitative (qualifier value)'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0019868', 'cui_str': 'Autoregulation'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0025520', 'cui_str': 'metabolism'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0000379', 'cui_str': '1,3-Benzodioxole-5-ethanamine, alpha-methyl-'}, {'cui': 'C0525033', 'cui_str': 'Probiotics'}, {'cui': 'C0019906', 'cui_str': 'Honey'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0242606', 'cui_str': 'Oxidative Stress'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",60.0,0.0768944,"Probiotic honey intake significantly reduced serum high-sensitivity C-reactive protein (hs-CRP) (- 1.9 ± 2.4 vs. - 0.2 ± 2.7 mg/L, P = 0.01) and plasma malondialdehyde (MDA) levels (- 0.1 ± 0.6 vs. + 0.6 ± 1.0 μmol/L, P = 0.002) compared with the control honey.","[{'ForeName': 'Navid', 'Initials': 'N', 'LastName': 'Mazruei Arani', 'Affiliation': 'Department of Food Science and Technology, North Tehran Branch, Islamic Azad University, Tehran, Iran.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Emam-Djomeh', 'Affiliation': 'Department of Food Science, Technology and Engineering Faculty of Agricultural Engineering and Technology, University of Tehran, Tehran, Iran.'}, {'ForeName': 'Hamid', 'Initials': 'H', 'LastName': 'Tavakolipour', 'Affiliation': 'Department of Food Science and Technology, Sabzevar Branch, Islamic Azad University, Sabzevar, Iran.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Sharafati-Chaleshtori', 'Affiliation': 'Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences, Kashan, I.R., Iran.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Soleimani', 'Affiliation': 'Department of Internal Medicine, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Zatollah', 'Initials': 'Z', 'LastName': 'Asemi', 'Affiliation': 'Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences, Kashan, I.R., Iran. asemi_r@yahoo.com.'}]",Probiotics and antimicrobial proteins,['10.1007/s12602-018-9468-x'] 1077,31058797,Using the immediate blood pressure benefits of exercise to improve exercise adherence among adults with hypertension: a randomized clinical trial.,"BACKGROUND A single exercise session evokes immediate blood pressure (BP) reductions that persist for at least 24 h, termed postexercise hypotension (PEH). Self-monitoring of PEH may foster positive outcome expectations of exercise, and thus, enhance exercise adherence among adults with hypertension. PURPOSE To compare the efficacy of self-monitoring of exercise (EXERCISE) versus exercise and PEH (EXERCISE + PEH) to improve exercise adherence and BP control among adults with hypertension. METHODS Adults with high BP were randomized to EXERCISE (n = 12) or EXERCISE + PEH (n = 12). Participants underwent supervised, moderate intensity aerobic exercise training for 40-50 min/session, 3 days/week for 12 weeks and encouraged to exercise unsupervised at home at least 30 min/day, 1-2 days/week. EXERCISE + PEH also self-monitored BP before and after exercise. Adherence was calculated as [(no. of exercise sessions performed/no. of possible exercise sessions) × 100%]. BP was measured pre and posttraining. RESULTS Healthy, middle-aged (52.3 ± 10.8 years) men (n = 11) and women (n = 13) with hypertension (136.2 ± 10.7/85.2 ± 8.9 mmHg) completed exercise training with 87.9 ± 12.1% adherence. EXERCISE + PEH demonstrated greater adherence to supervised training (94.3 ± 6.6%) than EXERCISE (81.6 ± 13.2%; P = 0.007). EXERCISE + PEH performed 32.6 ± 22.5 min/week more unsupervised home exercise than EXERCISE (P = 0.004), resulting in greater exercise adherence (107.3 ± 18.7%) than EXERCISE (82.7 ± 12.2%; P = 0.002). Post versus pretraining BP was reduced -7.4 ± 11.3/-4.9 ± 9.9 mmHg (P < 0.025) with no statistical difference between EXERCISE (-5.2 ± 13.3/-3.6 ± 6.1 mmHg) and EXERCISE + PEH (-9.9 ± 11.3/-6.1 ± 6.9 mmHg; P > 0.344). CONCLUSION The current study is the first to demonstrate that PEH self-monitoring is an efficacious tool to improve exercise adherence among a small sample of adults with hypertension. Future research among a larger, more diverse sample is needed to confirm these novel findings and determine whether EXERCISE + PEH translates to better BP control relative to EXERCISE self-monitoring alone.",2019,"EXERCISE + PEH performed 32.6 ± 22.5 min/week more unsupervised home exercise than EXERCISE (P = 0.004), resulting in greater exercise adherence (107.3 ± 18.7%) than EXERCISE (82.7 ± 12.2%; P = 0.002).","['adults with hypertension.\nPURPOSE', 'Adults with high BP', 'Healthy, middle-aged (52.3\u200a±\u200a10.8 years) men (n\u200a=\u200a11) and women (n\u200a=\u200a13) with hypertension (136.2\u200a±\u200a10.7/85.2\u200a±\u200a8.9\u200ammHg) completed', 'adults with hypertension']","['EXERCISE\u200a+\u200aPEH', 'exercise training', 'moderate intensity aerobic exercise training', 'self-monitoring of exercise (EXERCISE) versus exercise and PEH (EXERCISE\u200a+\u200aPEH', 'exercise']","['Adherence', 'postexercise hypotension (PEH', 'BP', 'blood pressure (BP) reductions', 'exercise adherence']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C1285529', 'cui_str': 'Purpose (attribute)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0205847', 'cui_str': 'Middle Aged'}, {'cui': 'C4517523', 'cui_str': '10.8'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439475', 'cui_str': 'torr (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0001701', 'cui_str': 'Exercise, Aerobic'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0588436', 'cui_str': 'Self-monitoring (regime/therapy)'}]","[{'cui': 'C2936233', 'cui_str': 'Postexercise Hypotension'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]",,0.0477833,"EXERCISE + PEH performed 32.6 ± 22.5 min/week more unsupervised home exercise than EXERCISE (P = 0.004), resulting in greater exercise adherence (107.3 ± 18.7%) than EXERCISE (82.7 ± 12.2%; P = 0.002).","[{'ForeName': 'Amanda L', 'Initials': 'AL', 'LastName': 'Zaleski', 'Affiliation': 'Department of Kinesiology, University of Connecticut, Storrs.'}, {'ForeName': 'Beth A', 'Initials': 'BA', 'LastName': 'Taylor', 'Affiliation': 'Department of Kinesiology, University of Connecticut, Storrs.'}, {'ForeName': 'Crystal L', 'Initials': 'CL', 'LastName': 'Park', 'Affiliation': 'Department of Psychology, University of Connecticut, Storrs, Connecticut, USA.'}, {'ForeName': 'Lucas P', 'Initials': 'LP', 'LastName': 'Santos', 'Affiliation': 'Exercise Pathophysiology Laboratory, Hospital de Clínicas de Porto Alegre.'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Panza', 'Affiliation': 'Department of Kinesiology, University of Connecticut, Storrs.'}, {'ForeName': 'Melody', 'Initials': 'M', 'LastName': 'Kramarz', 'Affiliation': 'Department of Kinesiology, University of Connecticut, Storrs.'}, {'ForeName': 'Kyle', 'Initials': 'K', 'LastName': 'McCormick', 'Affiliation': 'Department of Kinesiology, University of Connecticut, Storrs.'}, {'ForeName': 'Paul D', 'Initials': 'PD', 'LastName': 'Thompson', 'Affiliation': 'Department of Preventive Cardiology, Hartford Hospital, Hartford.'}, {'ForeName': 'Antonio B', 'Initials': 'AB', 'LastName': 'Fernandez', 'Affiliation': 'Department of Preventive Cardiology, Hartford Hospital, Hartford.'}, {'ForeName': 'Ming-Hui', 'Initials': 'MH', 'LastName': 'Chen', 'Affiliation': 'Department of Statistics, University of Connecticut, Storrs, Connecticut.'}, {'ForeName': 'Bryan', 'Initials': 'B', 'LastName': 'Blissmer', 'Affiliation': 'College of Health Sciences, University of Rhode Island, Kingston, Rhode Island.'}, {'ForeName': 'Kim M', 'Initials': 'KM', 'LastName': 'Gans', 'Affiliation': 'Department of Human Development and Family Studies, University of Connecticut, Storrs, Connecticut, USA.'}, {'ForeName': 'Linda S', 'Initials': 'LS', 'LastName': 'Pescatello', 'Affiliation': 'Department of Kinesiology, University of Connecticut, Storrs.'}]",Journal of hypertension,['10.1097/HJH.0000000000002115'] 1078,29751360,IntAct: intra-operative fluorescence angiography to prevent anastomotic leak in rectal cancer surgery: a randomized controlled trial.,"AIM Anastomotic leak (AL) is a major complication of rectal cancer surgery. Despite advances in surgical practice, the rates of AL have remained static, at around 10-15%. The aetiology of AL is multifactorial, but one of the most crucial risk factors, which is mostly under the control of the surgeon, is blood supply to the anastomosis. The MRC/NIHR IntAct study will determine whether assessment of anastomotic perfusion using a fluorescent dye (indocyanine green) and near-infrared laparoscopy can minimize the rate of AL leak compared with conventional white-light laparoscopy. Two mechanistic sub-studies will explore the role of the rectal microbiome in AL and the predictive value of CT angiography/perfusion studies. METHOD IntAct is a prospective, unblinded, parallel-group, multicentre, European, randomized controlled trial comparing surgery with intra-operative fluorescence angiography (IFA) against standard care (surgery with no IFA). The primary end-point is rate of clinical AL at 90 days following surgery. Secondary end-points include all AL (clinical and radiological), change in planned anastomosis, complications and re-interventions, use of stoma, cost-effectiveness of the intervention and quality of life. Patients should have a diagnosis of adenocarcinoma of the rectum suitable for potentially curative surgery by anterior resection. Over 3 years, 880 patients from 25 European centres will be recruited and followed up for 90 days. DISCUSSION IntAct will rigorously evaluate the use of IFA in rectal cancer surgery and explore the role of the microbiome in AL and the predictive value of preoperative CT angiography/perfusion scanning.",2018,"Secondary end-points include all AL (clinical and radiological), change in planned anastomosis, complications and re-interventions, use of stoma, cost-effectiveness of the intervention and quality of life.","['rectal cancer surgery', '880 patients from 25 European centres will be recruited and followed up for 90\xa0days']","['IntAct: intra-operative fluorescence angiography', 'fluorescent dye (indocyanine green) and near-infrared laparoscopy', 'Anastomotic leak (AL', 'surgery with intra-operative fluorescence angiography (IFA) against standard care (surgery with no IFA']","['rate of clinical AL', 'anastomotic leak', 'AL (clinical and radiological), change in planned anastomosis, complications and re-interventions, use of stoma, cost-effectiveness of the intervention and quality of life']","[{'cui': 'C0007113', 'cui_str': 'Cancer of Rectum'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0239307', 'cui_str': 'European (ethnic group)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]","[{'cui': 'C0205266', 'cui_str': 'Intact (qualifier value)'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C0086305', 'cui_str': 'Fluorescence Angiography'}, {'cui': 'C0016320', 'cui_str': 'Fluorescent Agents'}, {'cui': 'C0021234', 'cui_str': 'Indocyanine Green'}, {'cui': 'C0475806', 'cui_str': 'Nr - Near'}, {'cui': 'C0031150', 'cui_str': 'Celioscopy'}, {'cui': 'C0919691', 'cui_str': 'Anastomotic Leakage'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0919691', 'cui_str': 'Anastomotic Leakage'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C1301732', 'cui_str': 'Planned'}, {'cui': 'C0332853', 'cui_str': 'Anastomosis (morphologic abnormality)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C1955856', 'cui_str': 'Surgical Stoma'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0034380'}]",2.0,0.0770165,"Secondary end-points include all AL (clinical and radiological), change in planned anastomosis, complications and re-interventions, use of stoma, cost-effectiveness of the intervention and quality of life.","[{'ForeName': 'G', 'Initials': 'G', 'LastName': 'Armstrong', 'Affiliation': ""St James' University Hospital, Leeds, UK.""}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Croft', 'Affiliation': 'Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Corrigan', 'Affiliation': 'Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK.'}, {'ForeName': 'J M', 'Initials': 'JM', 'LastName': 'Brown', 'Affiliation': 'Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, UK.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Goh', 'Affiliation': ""School of Biomedical Engineering and Imaging Sciences, King's College London and Honorary Consultant Radiologist, Guy's and St Thomas' Hospitals NHS Foundation Trust, London, UK.""}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Quirke', 'Affiliation': 'University of Leeds, Leeds, UK.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Hulme', 'Affiliation': 'Academic Unit of Health Economics, Leeds Institute of Health Sciences, University of Leeds, Leeds, UK.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Tolan', 'Affiliation': 'Leeds Teaching Hospital Trust, Leeds, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Kirby', 'Affiliation': 'University of Leeds, Leeds, UK.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Cahill', 'Affiliation': 'University College Dublin, Dublin, Ireland.'}, {'ForeName': 'P R', 'Initials': 'PR', 'LastName': ""O'Connell"", 'Affiliation': ""St Vincent's University Hospital, Dublin, Ireland.""}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Miskovic', 'Affiliation': ""St Mark's Hospital, London, UK.""}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Coleman', 'Affiliation': 'Derriford Hospital, Plymouth NHS Trust, Plymouth, UK.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Jayne', 'Affiliation': ""Leeds Institute of Biological and Clinical Sciences, St James's University Hospital, Leeds, UK.""}]",Colorectal disease : the official journal of the Association of Coloproctology of Great Britain and Ireland,['10.1111/codi.14257'] 1079,31733786,Improving spatiotemporal gait parameters in spastic diplegic children using treadmill gait training.,"BACKGROUND Even though several physiotherapy techniques help to improve the spatiotemporal gait parameters of diplegic children, the efficacy of treadmill gait training together with conventional treatment techniques on spatiotemporal parameter improvement needs more investigation. OBJECTIVE This study's main purpose is to investigate the effect of treadmill gait training as an adjunct to conventional physiotherapy treatment on the spatiotemporal gait parameters of diplegic children. METHODS Twenty diplegic children were distributed randomly into two equal groups (a control group of ten children who received a traditional treatment and an experimental group of ten children who received the traditional treatment together with treadmill gait training). Gait data were collected using a Vicon three-dimensional motion analysis system during regular walking. RESULTS Walking speed, cadence, step length, stride length, and single limb support were enhanced in both groups (p < 0.05). Cadence and walking speed increased by 6.5 steps/min and 0.2 m/sec respectively in the experimental group, compared to the control group. Also, step length, stride length and single limb support time increased by 0.13 m, 0.27 m, and 0.07 s respectively in the experimental group, compared to the control group. CONCLUSION The use of treadmill gait training together with conventional physical therapy treatment enhances the walking performance of diplegic children by improving several spatiotemporal gait parameters. Furthermore, walking balance is improved by increasing the single-leg support time.",2019,"RESULTS Walking speed, cadence, step length, stride length, and single limb support were enhanced in both groups (p < 0.05).","['spastic diplegic children', 'Twenty diplegic children', 'diplegic children']","['traditional treatment and an experimental group of ten children who received the traditional treatment together with treadmill gait training', 'conventional physiotherapy treatment', 'treadmill gait training', 'treadmill gait training together with conventional physical therapy treatment']","['several spatiotemporal gait parameters', 'Walking speed, cadence, step length, stride length, and single limb support', 'spatiotemporal gait parameters', 'step length, stride length and single limb support time', 'Cadence and walking speed', 'walking balance']","[{'cui': 'C0443306', 'cui_str': 'Spastic'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0184069', 'cui_str': 'Treadmill, device (physical object)'}, {'cui': 'C0085673', 'cui_str': 'Gait training procedure (procedure)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}]","[{'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C2009910', 'cui_str': 'Gait Speed'}, {'cui': 'C0427126', 'cui_str': 'Step length (observable entity)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0015385', 'cui_str': 'Limbs'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}]",,0.0150828,"RESULTS Walking speed, cadence, step length, stride length, and single limb support were enhanced in both groups (p < 0.05).","[{'ForeName': 'Mariam A', 'Initials': 'MA', 'LastName': 'Ameer', 'Affiliation': 'Department of Biomechanics, College of Physical Therapy, Cairo University, Giza, Egypt; Department of Physical Therapy, College of Applied Medical Sciences, Dammam University, Dammam, Kingdom of Saudi Arabia. Electronic address: mariam.abdelmonim@cu.edu.eg.'}, {'ForeName': 'Eman S', 'Initials': 'ES', 'LastName': 'Fayez', 'Affiliation': 'Department of Neuromuscular Disorders and its Surgery, Faculty of Physical Therapy, Cairo University, Giza, Egypt.'}, {'ForeName': 'Hossameldien H', 'Initials': 'HH', 'LastName': 'Elkholy', 'Affiliation': 'Department of Biomechanics, College of Physical Therapy, Cairo University, Giza, Egypt.'}]",Journal of bodywork and movement therapies,['10.1016/j.jbmt.2019.02.003'] 1080,31736068,Effectiveness of the AS04-adjuvanted HPV-16/18 vaccine in reducing oropharyngeal HPV infections in young females-Results from a community-randomized trial.,"We studied effectiveness of the AS04-adjuvanted HPV-16/18 (AS04-HPV-16/18) vaccine against human papillomavirus (HPV) oropharyngeal infections associated with the increase of head/neck cancers in western countries. All 38,631 resident adolescents from 1994 to 1995 birth cohorts of 33 Finnish communities were invited in this community-randomized trial (NCT00534638). During 2008-2009, 11,275 girls and 6,129 boys were enrolled in three arms of 11 communities each. In Arm A, 90% of vaccinated girls/boys, and in Arm B, 90% of vaccinated girls received AS04-HPV-16/18 vaccine. Other Arm A/B and all Arm C vaccinated participants received control vaccine. All Arm A participants and Arm B female participants were blinded to vaccine allocation. Oropharyngeal samples were analyzed from 4,871 18.5-year-old females who attended follow-up visit 3-6 years postvaccination. HPV DNA prevalence was determined by SPF-10 LiPA and Multiplex type-specific PCR. Total vaccine effectiveness (VE) was defined as relative reduction of oropharyngeal HPV prevalence in pooled Arms A/B HPV-vaccinated females vs. all Arm C females. VE against oropharyngeal HPV-16/18, HPV-31/45 and HPV-31/33/45 infections were 82.4% (95% confidence intervals [CI]: 47.3-94.1), 75.3% (95%CI: 12.7-93.0) and 69.9% (95% CI: 29.6-87.1), respectively. In conclusion, the AS04-HPV-16/18 vaccine showed effectiveness against vaccine and nonvaccine HPV-types oropharyngeal infections in adolescent females up to 6 years postvaccination.",2020,Total vaccine effectiveness (VE) was defined as relative reduction of oropharyngeal HPV prevalence in pooled Arms A/B HPV-vaccinated females versus all Arm C females.,"['During 2008-2009, 11275 girls and 6129 boys were enrolled in 3 arms of 11 communities each', 'adolescent females', 'head/neck cancers in western countries', '4871 18.5-year-old females who attended follow-up visit 3-6\u2009years post-vaccination', 'young females', 'All 38631 resident adolescents from 1994-95 birth cohorts of 33 Finnish communities']","['AS04-adjuvanted HPV-16/18 vaccine', 'vaccine and non-vaccine HPV', 'AS04-HPV-16/18 vaccine', 'AS04-adjuvanted HPV-16/18 (AS04-HPV-16/18) vaccine', 'control vaccine']","['oropharyngeal HPV infections', 'HPV DNA prevalence', 'Total vaccine effectiveness (VE', 'oropharyngeal HPV prevalence', 'VE against oropharyngeal HPV-16/18, HPV-31/45 and HPV-31/33/45 infections']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0870221', 'cui_str': 'Boys'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0018670', 'cui_str': 'Head'}, {'cui': 'C0746787', 'cui_str': 'Cancer of Neck'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C4517611', 'cui_str': 'Eighteen point five'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0589121', 'cui_str': 'Follow-up visit (procedure)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0005615', 'cui_str': 'Birth'}]","[{'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C1522409', 'cui_str': 'Oropharyngeal route (qualifier value)'}, {'cui': 'C0343641', 'cui_str': 'HPV Infection'}, {'cui': 'C0012854', 'cui_str': 'Deoxyribonucleic Acid'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C3714514', 'cui_str': 'Infection'}]",95.0,0.274612,Total vaccine effectiveness (VE) was defined as relative reduction of oropharyngeal HPV prevalence in pooled Arms A/B HPV-vaccinated females versus all Arm C females.,"[{'ForeName': 'Matti', 'Initials': 'M', 'LastName': 'Lehtinen', 'Affiliation': 'Department of Infections and Cancer, German Cancer Research Center (DKFZ), Heidelberg, Germany.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Apter', 'Affiliation': 'VL-Medi, Helsinki, Finland.'}, {'ForeName': 'Tiina', 'Initials': 'T', 'LastName': 'Eriksson', 'Affiliation': 'Faculty of Social Sciences, University of Tampere, Tampere, Finland.'}, {'ForeName': 'Katja', 'Initials': 'K', 'LastName': 'Harjula', 'Affiliation': 'Faculty of Social Sciences, University of Tampere, Tampere, Finland.'}, {'ForeName': 'Mari', 'Initials': 'M', 'LastName': 'Hokkanen', 'Affiliation': 'Faculty of Social Sciences, University of Tampere, Tampere, Finland.'}, {'ForeName': 'Tuomas', 'Initials': 'T', 'LastName': 'Lehtinen', 'Affiliation': 'Department of Laboratory Medicine, Karolinska Institute, Stockholm, Sweden.'}, {'ForeName': 'Kari', 'Initials': 'K', 'LastName': 'Natunen', 'Affiliation': 'Faculty of Social Sciences, University of Tampere, Tampere, Finland.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Damaso', 'Affiliation': 'GSK, Wavre, Belgium.'}, {'ForeName': 'Maaria', 'Initials': 'M', 'LastName': 'Soila', 'Affiliation': 'GSK, Espoo, Finland.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Bi', 'Affiliation': 'GSK, Wavre, Belgium.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Struyf', 'Affiliation': 'GSK, Wavre, Belgium.'}]",International journal of cancer,['10.1002/ijc.32791'] 1081,30888705,"Feasibility, Acceptability, and Initial Efficacy of Delivering Alcohol Use Cognitive Interventions via Crowdsourcing.","BACKGROUND Inhibitory control training and working memory training are 2 cognitive interventions that have been considered for alcohol use disorder (AUD). Existing studies have typically relied on small samples that preclude the evaluation of small effects. Crowdsourcing is a sampling method that can address these limitations by effectively and efficiently recruiting large samples with varying health histories. This study tested the feasibility and acceptability of delivering cognitive training interventions via crowdsourcing. METHODS Participants with AUD were recruited from the crowdsourcing website Amazon Mechanical Turk (mTurk) (ClinicalTrials.gov; NCT03438539). Following completion of a baseline survey, participants were randomized to an inhibitory control, working memory, or control training condition. Participants were asked to complete training tasks daily over a 2-week period. Follow-up assessments evaluating acceptability measures and alcohol and soda consumption were completed immediately following and 2 weeks after training. RESULTS Response rates were satisfactory over the 2-week intervention period (65% of training tasks completed), and performance on training tasks was consistent with expected effects. A majority of participants indicated that they were satisfied with the study procedures (94.6%), would participate again (97.4%), and would consider incorporating the training task in their daily life (81.1%). Modest reductions in alcohol consumption were observed (e.g., 0.5 drinking day/wk), primarily in the inhibitory control group, and these effects were selective to alcohol use and did not extend to soda consumption. CONCLUSIONS These findings demonstrate the feasibility and acceptability of utilizing crowdsourcing methods for interventions development. Such a demonstration helps establish the crowdsourcing setting for future large sample studies testing novel interventions for AUD and other substance use disorders.",2019,"Modest reductions in alcohol consumption were observed (e.g., 0.5 drinking day/wk), primarily in the inhibitory control group, and these effects were selective to alcohol use and did not extend to soda consumption. ",['Participants with AUD'],"['inhibitory control, working memory, or control training condition', 'cognitive training interventions via crowdsourcing']","['acceptability measures and alcohol and soda consumption', 'Feasibility, Acceptability, and Initial Efficacy', 'alcohol consumption']",[],"[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0025265', 'cui_str': 'Working Memory'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C3494386', 'cui_str': 'Crowd Sourcing'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}]",,0.0448796,"Modest reductions in alcohol consumption were observed (e.g., 0.5 drinking day/wk), primarily in the inhibitory control group, and these effects were selective to alcohol use and did not extend to soda consumption. ","[{'ForeName': 'Justin C', 'Initials': 'JC', 'LastName': 'Strickland', 'Affiliation': 'Department of Psychology , University of Kentucky College of Arts and Sciences, Lexington, Kentucky.'}, {'ForeName': 'J Chauncey', 'Initials': 'JC', 'LastName': 'Hill', 'Affiliation': 'Department of Mathematics and Statistics , Washington University in St. Louis College of Arts and Sciences, St. Louis, Missouri.'}, {'ForeName': 'William W', 'Initials': 'WW', 'LastName': 'Stoops', 'Affiliation': 'Department of Psychology , University of Kentucky College of Arts and Sciences, Lexington, Kentucky.'}, {'ForeName': 'Craig R', 'Initials': 'CR', 'LastName': 'Rush', 'Affiliation': 'Department of Psychology , University of Kentucky College of Arts and Sciences, Lexington, Kentucky.'}]","Alcoholism, clinical and experimental research",['10.1111/acer.13987'] 1082,31014313,Evaluation of an intervention to promote walking during the commute to work: a cluster randomised controlled trial.,"BACKGROUND Opportunities for working adults to accumulate recommended physical activity levels (at least 150 min of moderate intensity physical activity in bouts of at least 10 min throughout the week) may include the commute to work. Systematic reviews of interventions to increase active transport suggest studies have tended to be of poor quality, relying on self-report and lacking robust statistical analyses. METHODS We conducted a multi-centre parallel-arm cluster randomised controlled trial, in workplaces in south-west England and south Wales, to assess the effectiveness of a behavioural intervention to increase walking during the commute. Workplace-based Walk to Work promoters were trained to implement a 10-week intervention incorporating key behavioural change techniques: providing information; encouraging intention formation; identifying barriers and solutions; goal setting; self-monitoring; providing general encouragement; identifying social support; reviewing goals, and; relapse prevention. Physical activity outcomes were objectively measured using accelerometers and GPS receivers at baseline and 12-month follow-up. The primary outcome was daily minutes of moderate to vigorous physical activity (MVPA). Secondary outcomes included overall levels of physical activity and modal shift (from private car to walking). Cost-consequences analysis included employer, employee and health service costs and outcomes. RESULTS Six hundred fifty-four participants were recruited across 87 workplaces: 10 micro (5-9 employees); 35 small (10-49); 22 medium (50-250); 20 large (250+). The majority of participants lived more than two kilometres from their place of work (89%) and travelled to work by car (65%). At 12-month follow-up, 84 workplaces (41 intervention, 43 control) and 477 employees (73% of those originally recruited) took part in data collection activities. There was no evidence of an intervention effect on MVPA or overall physical activity at 12-month follow-up. The intervention cost on average £181.97 per workplace and £24.19 per participating employee. CONCLUSIONS The intervention, focusing primarily on individual behaviour change, was insufficient to change travel behaviour. Our findings contribute to the argument that attention should be directed towards a whole systems approach, focusing on interactions between the correlates of travel behaviour. TRIAL REGISTRATION ISRCTN15009100 . Prospectively registered. (Date assigned: 10/12/2014).",2019,There was no evidence of an intervention effect on MVPA or overall physical activity at 12-month follow-up.,"['84 workplaces (41 intervention, 43 control) and 477 employees (73% of those originally recruited) took part in data collection activities', 'Six hundred fifty-four participants were recruited across 87 workplaces: 10 micro (5-9 employees); 35 small (10-49); 22 medium (50-250); 20 large (250', 'workplaces in south-west England and south Wales']",['behavioural intervention'],"['MVPA or overall physical activity', 'daily minutes of moderate to vigorous physical activity (MVPA', 'Physical activity outcomes', 'overall levels of physical activity and modal shift (from private car to walking', 'employer, employee and health service costs and outcomes', 'physical activity levels']","[{'cui': 'C0162579', 'cui_str': 'Job Site'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0599987', 'cui_str': 'Employee (person)'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0010995', 'cui_str': 'Data Collection'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C4517807', 'cui_str': 'Fifty-four'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C0439536', 'cui_str': 'Medium (qualifier value)'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0014282', 'cui_str': 'England'}]",[],"[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0333051', 'cui_str': 'Shift (morphologic abnormality)'}, {'cui': 'C4521534', 'cui_str': 'US Military enlisted E1'}, {'cui': 'C0004381', 'cui_str': 'Automobiles'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C1274022', 'cui_str': 'Employer'}, {'cui': 'C0599987', 'cui_str': 'Employee (person)'}, {'cui': 'C0018747', 'cui_str': 'Health Services'}, {'cui': 'C0010186', 'cui_str': 'Cost'}]",654.0,0.145245,There was no evidence of an intervention effect on MVPA or overall physical activity at 12-month follow-up.,"[{'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Audrey', 'Affiliation': 'Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, England. Suzanne.audrey@bristol.ac.uk.'}, {'ForeName': 'Harriet', 'Initials': 'H', 'LastName': 'Fisher', 'Affiliation': 'Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, England.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Cooper', 'Affiliation': 'Centre for Exercise, Nutrition and Health Sciences and National Institute for Health Research Bristol Biomedical Research Centre, University Hospitals Bristol NHS Foundation Trust and University of Bristol, Bristol, England.'}, {'ForeName': 'Daisy', 'Initials': 'D', 'LastName': 'Gaunt', 'Affiliation': 'Bristol Randomised Trials Collaboration, Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, England.'}, {'ForeName': 'Kirsty', 'Initials': 'K', 'LastName': 'Garfield', 'Affiliation': 'Bristol Randomised Trials Collaboration, Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, England.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Metcalfe', 'Affiliation': 'Bristol Randomised Trials Collaboration, Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, England.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Hollingworth', 'Affiliation': 'Bristol Randomised Trials Collaboration, Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, England.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Gillison', 'Affiliation': 'Department for Health, University of Bath, Bath, England.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Gabe-Walters', 'Affiliation': 'Swansea University Medical School, Swansea, Wales.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Rodgers', 'Affiliation': 'Swansea University Medical School, Swansea, Wales.'}, {'ForeName': 'Adrian L', 'Initials': 'AL', 'LastName': 'Davis', 'Affiliation': 'Transport Research Institute, Edinburgh Napier University, Edinburgh, Scotland.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Insall', 'Affiliation': 'Insall & Coe, Bristol, England.'}, {'ForeName': 'Sunita', 'Initials': 'S', 'LastName': 'Procter', 'Affiliation': 'Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, England.'}]",BMC public health,['10.1186/s12889-019-6791-4'] 1083,31012119,Progressive muscle relaxation for patients with chronic schizophrenia: A randomized controlled study.,"PURPOSE To evaluate progressive muscle relaxation (PMR) as an intervention for anxiety, psychotic symptoms, and quality of life (QOL) in patients with chronic schizophrenia. DESIGN AND METHODS Eighty patients were recruited from a Taiwanese psychiatry ward. The intervention group received group PMR; control group received treatment-as-usual. RESULTS The results indicated that PMR might have a short-term effect on reducing anxiety, improving psychotic syndromes, and QOL among patients with chronic schizophrenia; however, the effectiveness at the 3-month follow-up was not evident. PRACTICE IMPLICATIONS Both the psychiatric patients and the health institutions may be able to list PMR as a clinical routine care, and then become a mental health practice strategy for mental patients to improve the quality of mental care. IMPLICATIONS FOR NURSING PRACTICE Our studies suggest that prevention of severe mental illness among patients with schizophrenia requires PMR interventions. PMR had an immediate effect, and it is possible that a shorter intervention period using this approach would also be successful.",2020,"The results indicated that PMR might have a short-term effect on reducing anxiety, improving psychotic syndromes, and QOL among patients with chronic schizophrenia; however, the effectiveness at the 3-month follow-up was not evident. ","['Eighty patients were recruited from a Taiwanese psychiatry ward', 'patients with schizophrenia requires PMR interventions', 'patients with chronic schizophrenia']","['PMR', 'progressive muscle relaxation (PMR', 'group PMR; control group received treatment-as-usual']","['Progressive muscle relaxation', 'severe mental illness', 'reducing anxiety, improving psychotic syndromes, and QOL', 'anxiety, psychotic symptoms, and quality of life (QOL']","[{'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1556096', 'cui_str': 'Taiwanese (ethnic group)'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}, {'cui': 'C1305702', 'cui_str': 'Ward (environment)'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C0221765', 'cui_str': 'Chronic schizophrenia (disorder)'}]","[{'cui': 'C0004361', 'cui_str': 'Progressive Relaxation'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0004361', 'cui_str': 'Progressive Relaxation'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder (disorder)'}, {'cui': 'C0150135', 'cui_str': 'Reducing anxiety'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0033975', 'cui_str': 'Psychoses'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0871189', 'cui_str': 'Psychotic symptom'}, {'cui': 'C0034380'}]",80.0,0.0348643,"The results indicated that PMR might have a short-term effect on reducing anxiety, improving psychotic syndromes, and QOL among patients with chronic schizophrenia; however, the effectiveness at the 3-month follow-up was not evident. ","[{'ForeName': 'Shu-Min', 'Initials': 'SM', 'LastName': 'Lu', 'Affiliation': 'School of Nursing, Hsin Sheng Junior College of Medical Care and Management, Taoyuan, Taiwan.'}, {'ForeName': 'Mei-Feng', 'Initials': 'MF', 'LastName': 'Lin', 'Affiliation': 'Department of Nursing, College of Medicine, National Cheng Kung University, Tainan, Taiwan.'}, {'ForeName': 'Hsiu-Ju', 'Initials': 'HJ', 'LastName': 'Chang', 'Affiliation': 'School of Nursing, College of Nursing, Taipei Medical University, Taipei, Taiwan.'}]",Perspectives in psychiatric care,['10.1111/ppc.12384'] 1084,32407272,Influence of Rifampicin Pre-treatment on the In vivo Pharmacokinetics of Metoclopramide in Pakistani Healthy Volunteers Following Concurrent Oral Administration.,"BACKGROUND Metoclopramide is metabolized by various cytochrome P450 (CYP) enzymes such as CYP3A4, CYP1A2, CYP2D6, CYP2C9, and CYP2C19. Rifampicin is a non-selective inducer of P-glycoprotein (P-gp) and CYP enzymes such as CYP3A4 and others. OBJECTIVE This study was aimed at the evaluation of rifampicin's enzyme induction effect on the pharmacokinetic parameters of orally administered metoclopramide. METHOD This randomized, single-blind, two-phase cross-over pharmacokinetic study separated by a 4-week washout period was conducted at a single center in Pakistan. It involved twelve Pakistani healthy male volunteers (nonsmokers) divided into two groups. In the reference phase, each volunteer received a single oral dose of 20 mg metoclopramide (Maxolon 10 mg, GlaxoSmithKline, Pakistan), while in the rifampicin-treated phase, each volunteer received 600 mg rifampicin once daily for 6 days through oral route. On day 6, metoclopramide (20 mg) was administered 2 hours after the last pretreatment dose of rifampicin. The serial blood samples were collected on predetermined time points (0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14, and 18 h) and analyzed using a validated HPLC method for the determination of pharmacokinetic parameters, i.e. Cmax, Tmax, and AUC0-∞ of metoclopramide. The whole study was monitored by an unblinded clinician for the purpose of volunteer's health safety. RESULTS All the volunteers participated in the study until the end. Twelve healthy Pakistani males having mean age 26.0 (range 20.6-34.1) years and body mass index 25.1 (range 16.2-31.5) kg/m2 were included in this study after taking written informed consent. Rifampicin significantly (P<0.05) decreased the mean Cmax, AUC0-∞ and T1/2 of metoclopramide by 35%, 68%, and 44%, respectively. The laboratory tests did not reveal any significant change in the biochemical, physical, hematological, or urinalytical values before and after metoclopramide treatment. None of the volunteers complained of any discomfort during the study. CONCLUSION Rifampicin noticeably decreased the concentration of plasma metoclopramide. These results give in vivo confirmation of the CYP3A4 involvement in the metoclopramide metabolism, in addition to CYP2D6. Therefore, metoclopramide pharmacokinetics may be clinically affected by rifampicin and other potent enzyme inducers.",2020,"The laboratory tests did not reveal any significant change in the biochemical, physical, hematological, or urinalytical values before and after metoclopramide treatment.","['Pakistani Healthy Volunteers Following Concurrent Oral Administration', 'twelve Pakistani healthy male volunteers (non-smokers', 'Twelve healthy Pakistani males having to mean age 26.0 (range 20.6-34.1) years and body mass index 25.1 (range']","['Rifampicin', 'Rifampicin Pre-treatment', 'metoclopramide', 'rifampicin', 'Metoclopramide', 'metoclopramide (Maxolon 10 mg, GlaxoSmithKline, Pakistan']","['biochemical, physical, hematological, or urinalytical values', 'concentration of plasma metoclopramide', 'pharmacokinetic parameters, i.e. Cmax, Tmax, and AUC0-∞ of metoclopramide', 'serial blood samples', 'mean Cmax, AUC0-∞']","[{'cui': 'C0240620', 'cui_str': 'Pakistani'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0001563', 'cui_str': 'Medication administration: oral'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0337672', 'cui_str': 'Non-smoker'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C0035608', 'cui_str': 'Rifampin'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0025853', 'cui_str': 'Metoclopramide'}, {'cui': 'C0699913', 'cui_str': 'Maxolon'}, {'cui': 'C0030211', 'cui_str': 'Pakistan'}]","[{'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0025853', 'cui_str': 'Metoclopramide'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0031082', 'cui_str': 'Periodicals'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",12.0,0.0264346,"The laboratory tests did not reveal any significant change in the biochemical, physical, hematological, or urinalytical values before and after metoclopramide treatment.","[{'ForeName': 'Iram', 'Initials': 'I', 'LastName': 'Kaukab', 'Affiliation': 'Department of Pharmaceutics, Faculty of Pharmacy, Bahauddin Zakariya University, Multan, Pakistan.'}, {'ForeName': 'Syed Nisar Hussain', 'Initials': 'SNH', 'LastName': 'Shah', 'Affiliation': 'Department of Pharmaceutics, Faculty of Pharmacy, Bahauddin Zakariya University, Multan, Pakistan.'}, {'ForeName': 'Muhammad Asad', 'Initials': 'MA', 'LastName': 'Abrar', 'Affiliation': 'Department of Pharmaceutics, Faculty of Pharmacy, Bahauddin Zakariya University, Multan, Pakistan.'}, {'ForeName': 'Naveed', 'Initials': 'N', 'LastName': 'Anwer', 'Affiliation': 'Saulat Institute of Pharmaceutical Sciences, Quaid-e-Azam University, Islamabad, Pakistan.'}, {'ForeName': 'Ghulam', 'Initials': 'G', 'LastName': 'Murtaza', 'Affiliation': 'Department of Pharmacy, COMSATS Institute of Information Technology, Lahore, Pakistan.'}]",Current drug metabolism,['10.2174/1389200221666200514132654'] 1085,31040207,The Double-Trunk Mask Improves Oxygenation During High-Flow Nasal Cannula Therapy for Acute Hypoxemic Respiratory Failure.,"BACKGROUND High-flow nasal cannula (HFNC) oxygen therapy is used to deliver an F IO 2 from 0.21 to 1.0. The double-trunk mask (DTM) is a device designed to increase the F IO 2 in patients with a high inspiratory flow demand. The aim of our study was to evaluate the effect of DTM in hypoxemic subjects already receiving HFNC. METHODS We report a prospective multi-center crossover pilot study including 15 subjects treated with HFNC for acute hypoxemic respiratory failure. Measurements were performed at the end of 30-min periods with HFNC only, with HFNC + DTM, and again with HFNC only. RESULTS Compared with HFNC alone, HFNC + DTM increased P aO 2 from 68 ± 14 mm Hg to 85 ± 22 mm Hg ( P < .001) and did not affect P aCO 2 ( P = .18). In the 11 responders, the P aO 2 increased from 63 ± 12 mm Hg to 88 ± 23 mm Hg ( P < .001). No complications were reported during DTM use. CONCLUSION In subjects receiving oxygen via HFNC, the addition of the DTM over the HFNC increased P aO 2 without changing the P aCO 2 .",2019,"No complications were reported during DTM use. ","['hypoxemic subjects already receiving HFNC', 'Acute Hypoxemic Respiratory Failure', '15 subjects treated with HFNC for acute hypoxemic respiratory failure', 'patients with a high inspiratory flow demand']","['DTM', 'Double-Trunk Mask Improves Oxygenation', 'HFNC) oxygen therapy', 'High-Flow Nasal Cannula Therapy', 'High-flow nasal cannula ', 'double-trunk mask (DTM', 'HFNC alone, HFNC + DTM']",[],"[{'cui': 'C4039867', 'cui_str': 'Acute type 1 respiratory failure'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0004048', 'cui_str': 'Inhalation'}]","[{'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0460005', 'cui_str': 'Torso'}, {'cui': 'C0024861', 'cui_str': 'Masks'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0184633', 'cui_str': 'Oxygen Inhalation Therapy'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0179574', 'cui_str': 'Nasal Cannula'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]",[],,0.171578,"No complications were reported during DTM use. ","[{'ForeName': 'Frédéric', 'Initials': 'F', 'LastName': 'Duprez', 'Affiliation': ""ICU, Epicura Hospital, Hornu, Belgium, the Institut de Recherche Expérimentale et Clinique (IREC), Pole de Pneumologie, ORL & Dermatologie, Service de Pneumologie, Université Catholique de Louvain, Brussels, Belgium, and the Laboratoire de l'Effort et du Mouvement Condorcet, Tournai, Belgium. frederic.duprez@epicura.be.""}, {'ForeName': 'Arnaud', 'Initials': 'A', 'LastName': 'Bruyneel', 'Affiliation': 'Intensive Care Unit, Université Catholique de Louvain, Brussels, Belgium, and the Haute Ecole Provinciale Condorcet, Mons, Belgium.'}, {'ForeName': 'Shahram', 'Initials': 'S', 'LastName': 'Machayekhi', 'Affiliation': 'ICU, Epicura Hospital, Hornu, Belgium.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Droguet', 'Affiliation': 'ICU, Tivoli Hospital, La Louvière, Belgium.'}, {'ForeName': 'Yves', 'Initials': 'Y', 'LastName': 'Bouckaert', 'Affiliation': 'ICU, Tivoli Hospital, La Louvière, Belgium.'}, {'ForeName': 'Serge', 'Initials': 'S', 'LastName': 'Brimioulle', 'Affiliation': 'Department of Intensive Care, Erasme Hospital, Brussels, Belgium.'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Cuvelier', 'Affiliation': ""Laboratoire de l'Effort et du Mouvement Condorcet, Tournai, Belgium.""}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Reychler', 'Affiliation': 'Institut de Recherche Expérimentale et Clinique (IREC), Pole de Pneumologie, ORL & Dermatologie, Service de Pneumologie, Université Catholique de Louvain, Brussels, Belgium.'}]",Respiratory care,['10.4187/respcare.06520'] 1086,31695168,Intrinsic connectomes are a predictive biomarker of remission in major depressive disorder.,"Although major depressive disorder (MDD) is associated with altered functional coupling between disparate neural networks, the degree to which such measures are ameliorated by antidepressant treatment is unclear. It is also unclear whether functional connectivity can be used as a predictive biomarker of treatment response. Here, we used whole-brain functional connectivity analysis to identify neural signatures of remission following antidepressant treatment, and to identify connectomic predictors of treatment response. 163 MDD and 62 healthy individuals underwent functional MRI during pre-treatment baseline and 8-week follow-up sessions. Patients were randomized to escitalopram, sertraline or venlafaxine-XR antidepressants and assessed at follow-up for remission. Baseline measures of intrinsic functional connectivity between each pair of 333 regions were analyzed to identify pre-treatment connectomic features that distinguish remitters from non-remitters. We then interrogated these connectomic differences to determine if they changed post-treatment, distinguished patients from controls, and were modulated by medication type. Irrespective of medication type, remitters were distinguished from non-remitters by greater connectivity within the default mode network (DMN); specifically, between the DMN, fronto-parietal and somatomotor networks, the DMN and visual, limbic, auditory and ventral attention networks, and between the fronto-parietal and somatomotor networks with cingulo-opercular and dorsal attention networks. This baseline hypo-connectivity for non-remitters also distinguished them from controls and increased following treatment. In contrast, connectivity for remitters was higher than controls at baseline and also following remission, suggesting a trait-like connectomic characteristic. Increased functional connectivity within and between large-scale intrinsic brain networks may characterize acute recovery with antidepressants in depression.",2020,"Irrespective of medication type, remitters were distinguished from non-remitters by greater connectivity within the default mode network (DMN); specifically, between the DMN, fronto-parietal and somatomotor networks, the DMN and visual, limbic, auditory and ventral attention networks, and between the fronto-parietal and somatomotor networks with cingulo-opercular and dorsal attention networks.",['163 MDD and 62 healthy individuals underwent'],"['escitalopram, sertraline or venlafaxine-XR antidepressants', 'functional MRI']","['connectivity for remitters', 'intrinsic functional connectivity']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C1099456', 'cui_str': 'Escitalopram'}, {'cui': 'C0074393', 'cui_str': 'Sertraline'}, {'cui': 'C0078569', 'cui_str': 'venlafaxine'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant Drugs'}, {'cui': 'C0376335', 'cui_str': 'fMRI'}]","[{'cui': 'C0439674', 'cui_str': 'Intrinsic (qualifier value)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}]",163.0,0.0349942,"Irrespective of medication type, remitters were distinguished from non-remitters by greater connectivity within the default mode network (DMN); specifically, between the DMN, fronto-parietal and somatomotor networks, the DMN and visual, limbic, auditory and ventral attention networks, and between the fronto-parietal and somatomotor networks with cingulo-opercular and dorsal attention networks.","[{'ForeName': 'Mayuresh S', 'Initials': 'MS', 'LastName': 'Korgaonkar', 'Affiliation': 'The Brain Dynamics Centre, Westmead Institute for Medical Research, The University of Sydney, Sydney, Australia. m.korgaonkar@sydney.edu.au.'}, {'ForeName': 'Andrea N', 'Initials': 'AN', 'LastName': 'Goldstein-Piekarski', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, California, USA.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Fornito', 'Affiliation': 'Brain and Mental Health Research Hub, Turner Institute for Brain and Mental Health & Monash Biomedical Imaging, Monash University, Clayton, Victoria, Australia.'}, {'ForeName': 'Leanne M', 'Initials': 'LM', 'LastName': 'Williams', 'Affiliation': 'The Brain Dynamics Centre, Westmead Institute for Medical Research, The University of Sydney, Sydney, Australia. leawilliams@stanford.edu.'}]",Molecular psychiatry,['10.1038/s41380-019-0574-2'] 1087,31041625,"Picture Pill Count: An Innovative, Reliable, Valid and Feasible Method to Measure Adherence to ART.","We report the reliability, validity, and feasibility of self-performed picture pill count (PPC) as an adherence measure that was used in a randomized trial with HIV positive people living in rural Georgia. The first 61 (of 149) participants conducted an additional PPC 1-2 days after baseline. Reliability, measured by a PPC scoring instrument, analyzed participants' ability to reproduce high quality pill count photographs free from artifact or blurring that could hamper accurate visualization of the pills and bottle labels. Except for label blur, baseline photographs (performed with coaching by study staff) and independently performed post-baseline photographs were rated as acceptable quality (> 93%). Label blur significantly worsened between the baseline and post-baseline scoring (93% vs 80%, p = 0.039), possibly indicating that participants required more education to ensure readability. Validity was determined by comparing the number of pills entered into the PC survey with the number of pills in the texted PPC; 77.5% of participants had perfectly matched pill counts (r = 0.690, p < 0.001). We found PCC to be a reliable and valid method of measuring adherence. The high rate of participant satisfaction underscores its feasibility. It provides an innovative alternative to other more invasive and labor intensive methods of measuring adherence using pill counts.",2019,"Label blur significantly worsened between the baseline and post-baseline scoring (93% vs 80%, p = 0.039), possibly indicating that participants required more education to ensure readability.",['HIV positive people living in rural Georgia'],['self-performed picture pill count (PPC'],"['Validity', 'Picture Pill Count']","[{'cui': 'C0019699', 'cui_str': 'HTLV-III Seroconversion'}, {'cui': 'C0017454', 'cui_str': 'Georgian S.S.R.'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0441469', 'cui_str': 'Picture (physical object)'}, {'cui': 'C0994475', 'cui_str': 'Pill (basic dose form)'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}]","[{'cui': 'C0042283', 'cui_str': 'Validity (Epidemiology)'}, {'cui': 'C0441469', 'cui_str': 'Picture (physical object)'}, {'cui': 'C0994475', 'cui_str': 'Pill (basic dose form)'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}]",149.0,0.138294,"Label blur significantly worsened between the baseline and post-baseline scoring (93% vs 80%, p = 0.039), possibly indicating that participants required more education to ensure readability.","[{'ForeName': 'Marcia M', 'Initials': 'MM', 'LastName': 'Holstad', 'Affiliation': 'Nell Hodgson School of Nursing, Emory University, 1520 Clifton Road, Atlanta, GA, 30322, USA. nurmmcd@emory.edu.'}, {'ForeName': 'Melinda', 'Initials': 'M', 'LastName': 'Higgins', 'Affiliation': 'Nell Hodgson School of Nursing, Emory University, 1520 Clifton Road, Atlanta, GA, 30322, USA.'}, {'ForeName': 'Maya', 'Initials': 'M', 'LastName': 'Bauman', 'Affiliation': 'Nell Hodgson School of Nursing, Emory University, 1520 Clifton Road, Atlanta, GA, 30322, USA.'}, {'ForeName': 'Eugene W', 'Initials': 'EW', 'LastName': 'Farber', 'Affiliation': 'School of Medicine, Department of Psychiatry and Behavioral Sciences, Emory University, Atlanta, GA, 30322, USA.'}, {'ForeName': 'Drenna', 'Initials': 'D', 'LastName': 'Waldrop-Valverde', 'Affiliation': 'Nell Hodgson School of Nursing, Emory University, 1520 Clifton Road, Atlanta, GA, 30322, USA.'}, {'ForeName': 'Oluchi', 'Initials': 'O', 'LastName': 'Okwandu', 'Affiliation': 'Nell Hodgson School of Nursing, Emory University, 1520 Clifton Road, Atlanta, GA, 30322, USA.'}, {'ForeName': 'Igho', 'Initials': 'I', 'LastName': 'Ofotokun', 'Affiliation': 'School of Medicine, Department of Medicine, Emory University, Atlanta, GA, 30322, USA.'}]",AIDS and behavior,['10.1007/s10461-019-02513-9'] 1088,31725692,Impact of Preoperative Acetaminophen and Carbohydrate Loading on Pain and Functional Status in Patients Undergoing Mohs Micrographic Surgery for Nonmelanoma Skin Cancers.,"BACKGROUND Preoperative acetaminophen and carbohydrate loading has been shown to improve the functional recovery of surgical patients. OBJECTIVE To determine the effects of preoperative acetaminophen and carbohydrates on functional outcomes and the use of pain medications after surgery in patients undergoing Mohs Micrographic Surgery (MMS) for nonmelanoma skin cancer (NMSC). MATERIALS AND METHODS One hundred patients treated with MMS for NMSC at an academic center were randomized into a control group receiving standard preoperative care or an intervention group receiving acetaminophen and carbohydrate drinks immediately before surgery. Patients rated levels of pain, thirst, hunger, anxiety, and fatigue on the day of surgery on a scale of 0 to 100, and reported through a phone interview the use of pain medications within 48 hours of surgery. RESULTS There was no significant difference between intervention and control groups in maximum pain score on the day of surgery; maximum pain score 48 hours after surgery; use of nonopioid pain medications; and use of opioids. However, the intervention group had lower anxiety levels during and at the end of surgery. CONCLUSION Patients undergoing MMS for NMSC reported very low levels of pain during and after surgery. Preoperative acetaminophen and carbohydrate loading had no impact on pain levels or the use of pain medications but did reduce levels of anxiety.",2020,Preoperative acetaminophen and carbohydrate loading had no impact on pain levels or the use of pain medications but did reduce levels of anxiety.,"['patients undergoing Mohs Micrographic Surgery (MMS) for nonmelanoma skin cancer (NMSC', 'One hundred patients treated with MMS for NMSC at an academic center', 'Patients Undergoing Mohs Micrographic Surgery for Nonmelanoma Skin Cancers']","['Preoperative Acetaminophen and Carbohydrate Loading', 'preoperative acetaminophen and carbohydrates', 'control group receiving standard preoperative care or an intervention group receiving acetaminophen and carbohydrate drinks immediately before surgery', 'acetaminophen and carbohydrate loading', 'Preoperative acetaminophen and carbohydrate loading']","['levels of pain, thirst, hunger, anxiety, and fatigue', 'lower anxiety levels', 'maximum pain score', 'pain levels', 'Pain and Functional Status', 'levels of anxiety']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0079850', 'cui_str': 'Micrographic Surgery, Mohs'}, {'cui': 'C0007114', 'cui_str': 'Cancer of Skin'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C4277655', 'cui_str': 'Diet, Carbohydrate Loading'}, {'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0033061', 'cui_str': 'Preoperative Care'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0452428', 'cui_str': 'Drinks (substance)'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0039971', 'cui_str': 'Thirst'}, {'cui': 'C0020175', 'cui_str': 'Hunger'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety (observable entity)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}]",100.0,0.0310906,Preoperative acetaminophen and carbohydrate loading had no impact on pain levels or the use of pain medications but did reduce levels of anxiety.,"[{'ForeName': 'Abdullah', 'Initials': 'A', 'LastName': 'Aleisa', 'Affiliation': 'Department of Dermatology, Tufts Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Naccarato', 'Affiliation': 'Department of Dermatology, Tufts School of Medicine, Department of Dermatology, Tufts University, Boston, Massachusetts.'}, {'ForeName': 'Morgan', 'Initials': 'M', 'LastName': 'Gramz', 'Affiliation': 'Department of Dermatology, Tufts Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Jalak', 'Initials': 'J', 'LastName': 'Patel', 'Affiliation': 'Department of Dermatology, Tufts Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Bichchau', 'Initials': 'B', 'LastName': 'Nguyen', 'Affiliation': 'Department of Dermatology, Tufts Medical Center, Boston, Massachusetts.'}]",Dermatologic surgery : official publication for American Society for Dermatologic Surgery [et al.],['10.1097/DSS.0000000000002161'] 1089,31021304,Reducing inhalant use in Latino adolescents through synchronized parent-adolescent interventions.,"This article presents the effects of a synchronized Latino youth/parent intervention on adolescent inhalant use. The analytic sample included only Latino adolescents ( n  = 487) between the ages of 12 and 14. Randomized at the school-level, the design included three possible conditions: (1) child and parent received the prevention interventions, (2) only the parent received the prevention intervention, (3) neither child or parent received the prevention interventions. Drawing from the eco-developmental perspective, the overall hypothesis was that youth randomly assigned to the condition with both interventions will report the strongest inhalant use prevention outcomes. Descriptive statistics and regression tests of significant group differences by treatment condition confirmed the overall hypothesis. Children receiving the youth intervention and whose parents received the synchronized parenting intervention reported the strongest desired inhalant prevention effects. The findings are interpreted from an eco-developmental perspective and implications for practice, policy, and future research are discussed.",2019,Children receiving the youth intervention and whose parents received the synchronized parenting intervention reported the strongest desired inhalant prevention effects.,"['Latino adolescents through synchronized parent-adolescent interventions', 'Latino adolescents ( n \u2009=\u2009487) between the ages of 12 and 14']","['synchronized parenting intervention', 'prevention interventions, (2) only the parent received the prevention intervention, (3) neither child or parent received the prevention interventions', 'synchronized Latino youth/parent intervention']",[],"[{'cui': 'C0086528', 'cui_str': 'Latinos'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0086528', 'cui_str': 'Latinos'}, {'cui': 'C0087178', 'cui_str': 'Youth'}]",[],487.0,0.0173387,Children receiving the youth intervention and whose parents received the synchronized parenting intervention reported the strongest desired inhalant prevention effects.,"[{'ForeName': 'Flavio F', 'Initials': 'FF', 'LastName': 'Marsiglia', 'Affiliation': 'a Southwest Interdisciplinary Research Center, School of Social Work , Arizona State University , Phoenix , Arizona , USA.'}, {'ForeName': 'Stephanie L', 'Initials': 'SL', 'LastName': 'Ayers', 'Affiliation': 'a Southwest Interdisciplinary Research Center, School of Social Work , Arizona State University , Phoenix , Arizona , USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Kiehne', 'Affiliation': 'a Southwest Interdisciplinary Research Center, School of Social Work , Arizona State University , Phoenix , Arizona , USA.'}]",Journal of prevention & intervention in the community,['10.1080/10852352.2019.1603675'] 1090,30733143,Transcutaneous spinal direct current stimulation improves locomotor learning in healthy humans.,"BACKGROUND Ambulation is an essential aspect of daily living and is often impaired after brain and spinal cord injuries. Despite the implementation of standard neurorehabilitative care, locomotor recovery is often incomplete. OBJECTIVE In this randomized, sham-controlled, double-blind, parallel design study, we aimed to determine if anodal transcutaneous spinal direct current stimulation (anodal tsDCS) could improve training effects on locomotion compared to sham (sham tsDCS) in healthy subjects. METHODS 43 participants underwent a single backwards locomotion training (BLT) session on a reverse treadmill with concurrent anodal (n = 22) or sham (n = 21) tsDCS. The primary outcome measure was speed gain measured 24 h post-training. We hypothesized that anodal tsDCS + BLT would improve training effects on backward locomotor speed compared to sham tsDCS + BLT. A subset of participants (n = 31) returned for two additional training days of either anodal (n = 16) or sham (n = 15) tsDCS and underwent (n = 29) H-reflex testing immediately before, immediately after, and 30 min post-training over three consecutive days. RESULTS A single session of anodal tsDCS + BLT elicited greater speed gain at 24 h relative to sham tsDCS + BLT (p = 0.008, two-sample t-test, adjusted for one interim analysis after the initial 12 subjects). Anodal tsDCS + BLT resulted in higher retention of the acquired skill at day 30 relative to sham tsDCS + BLT (p = 0.002) in the absence of significant group differences in online or offline learning over the three training days (p = 0.467 and p = 0.131). BLT resulted in transient down-regulation of H-reflex amplitude (Hmax/Mmax) in both test groups (p < 0.0001). However, the concurrent application of anodal-tsDCS with BLT elicited a longer lasting effect than sham-tsDCS + BLT (p = 0.050). CONCLUSION tsDCS improved locomotor skill acquisition and retention in healthy subjects and prolonged the physiological exercise-mediated downregulation of excitability of the alpha motoneuron pool. These results suggest that this strategy is worth exploring in neurorehabilitation of locomotor function.",2019,BLT resulted in transient down-regulation of H-reflex amplitude (Hmax/Mmax) in both test groups (p < 0.0001).,"['healthy humans', '43 participants underwent a', 'healthy subjects']","['BLT', 'Anodal tsDCS\xa0+\xa0BLT', 'single backwards locomotion training (BLT) session on a reverse treadmill with concurrent anodal (n\xa0=\xa022) or sham (n\xa0=\xa021) tsDCS', 'anodal transcutaneous spinal direct current stimulation (anodal tsDCS', 'tsDCS', 'sham (sham tsDCS', 'Transcutaneous spinal direct current stimulation', 'anodal tsDCS\xa0+\xa0BLT', 'anodal (n\xa0=\xa016) or sham (n\xa0=\xa015) tsDCS']","['locomotor learning', 'transient down-regulation of H-reflex amplitude (Hmax/Mmax', 'speed gain', 'online or offline learning', 'locomotor skill acquisition and retention', 'speed gain measured 24\xa0h post-training', 'higher retention of the acquired skill']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0023946', 'cui_str': 'Locomotor Activity'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0184069', 'cui_str': 'Treadmill, device (physical object)'}, {'cui': 'C0205420', 'cui_str': 'Concurrent (qualifier value)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C0442831', 'cui_str': 'Direct current (physical force)'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}]","[{'cui': 'C0205374', 'cui_str': 'Transitory (qualifier value)'}, {'cui': 'C0013081', 'cui_str': 'Down-Regulation (Physiology)'}, {'cui': 'C0018447', 'cui_str': 'H-Reflex'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0439661', 'cui_str': 'Acquired (qualifier value)'}]",43.0,0.296298,BLT resulted in transient down-regulation of H-reflex amplitude (Hmax/Mmax) in both test groups (p < 0.0001).,"[{'ForeName': 'Oluwole O', 'Initials': 'OO', 'LastName': 'Awosika', 'Affiliation': 'Human Cortical Physiology and Neurorehabilitation Section, NINDS, USA; Department of Neurology and Rehabilitation Medicine, University of Cincinnati, USA. Electronic address: oluwole.awosika@uc.edu.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Sandrini', 'Affiliation': 'Human Cortical Physiology and Neurorehabilitation Section, NINDS, USA; Department of Psychology, University of Roehampton, London, UK.'}, {'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Volochayev', 'Affiliation': 'Human Cortical Physiology and Neurorehabilitation Section, NINDS, USA.'}, {'ForeName': 'Ryan M', 'Initials': 'RM', 'LastName': 'Thompson', 'Affiliation': 'Human Cortical Physiology and Neurorehabilitation Section, NINDS, USA.'}, {'ForeName': 'Nathan', 'Initials': 'N', 'LastName': 'Fishman', 'Affiliation': 'Human Cortical Physiology and Neurorehabilitation Section, NINDS, USA.'}, {'ForeName': 'Tianxia', 'Initials': 'T', 'LastName': 'Wu', 'Affiliation': 'Clinical Trials Unit, NINDS, USA.'}, {'ForeName': 'Mary Kay', 'Initials': 'MK', 'LastName': 'Floeter', 'Affiliation': 'Motor Neuron Disorders Unit, NINDS, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Hallett', 'Affiliation': 'Human Motor Control Section, NINDS, USA.'}, {'ForeName': 'Leonardo G', 'Initials': 'LG', 'LastName': 'Cohen', 'Affiliation': 'Human Cortical Physiology and Neurorehabilitation Section, NINDS, USA.'}]",Brain stimulation,['10.1016/j.brs.2019.01.017'] 1091,30730425,Effects of Whole Body Vibration Therapy and Classic Physiotherapy on Postural Stability in People With Back Pain: A Randomized Trial.,"STUDY DESIGN This 2-step prospective randomized parallel trial evaluated postural stability in 65 back pain participants (61.6±7.9 y) and 50 nonback pain participants (61.2±8.6 y) in a first step using the MFT-S3-Check. In a second step, postural stability and questionnaires were evaluated in back pain participants before and after therapy with either whole body vibration therapy or classic physiotherapy. OBJECTIVE The first aim was to investigate whether the MFT-S3-Check is suitable to evaluate differences in postural stability in back pain and nonback pain participants. The second aim was to evaluate the effect of whole body vibration therapy and classic physiotherapy on postural stability and the influence of depressive symptoms and pain. SUMMARY OF BACKGROUND DATA Objective bodily measurement values in chronic back pain are rare; therefore, the evaluation of effectiveness of different therapies is difficult. METHODS Postural stability was investigated using stability-, sensorimotor-, and symmetry indexes, in standing and seated positions with the MFT-S3-Check. The following standard questionnaires were used to investigate pain and depressive symptoms: HADS, ODI, NASS, SF-36. RESULTS No significant difference in postural stability was found between back pain participants and the nonback pain group. None of the two training concepts in back pain participants was superior, concerning postural stability and pain. Both treatments showed positive effects, with significant improvements in postural stability in the classic physiotherapy group. Depressive symptoms had a significant correlation with pain intensity in back pain participants. CONCLUSIONS The MFT-S3-Check could not find a significant difference in postural stability between the back pain and nonback pain group in the study setting. Postural stability improved after treatment.",2019,The MFT-S3-Check could not find a significant difference in postural stability between the back pain and nonback pain group in the study setting.,"['65 back pain participants (61.6±7.9\u2009y) and 50 nonback pain participants (61.2±8.6\u2009y) in a first step using the MFT-S3-Check', 'back pain and nonback pain participants', 'People With Back Pain']","['Whole Body Vibration Therapy and Classic Physiotherapy', 'whole body vibration therapy or classic physiotherapy', 'whole body vibration therapy and classic physiotherapy', 'MFT-S3-Check']","['Depressive symptoms', 'postural stability', 'postural stability and questionnaires', 'depressive symptoms and pain', 'pain intensity', 'pain and depressive symptoms', 'postural stability and pain', 'Postural stability', 'Postural Stability']","[{'cui': 'C0004604', 'cui_str': 'Backache'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1261552', 'cui_str': 'Step'}]","[{'cui': 'C0444584', 'cui_str': 'Whole body (qualifier value)'}, {'cui': 'C0459800', 'cui_str': 'Vibration'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439658', 'cui_str': 'Classic (qualifier value)'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}]","[{'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0205278', 'cui_str': 'Postural (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}]",,0.10879,The MFT-S3-Check could not find a significant difference in postural stability between the back pain and nonback pain group in the study setting.,"[{'ForeName': 'Veronika', 'Initials': 'V', 'LastName': 'Wegener', 'Affiliation': 'Department of Orthopaedics, Physical Medicine and Rehabilitation, University, Hospital, LMU Munich, Marchioninistraße.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Rarack', 'Affiliation': 'Department of Orthopaedics, Physical Medicine and Rehabilitation, University, Hospital, LMU Munich, Marchioninistraße.'}, {'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Tiffe', 'Affiliation': 'Institute for Medical Information Processing, Biometrics and Epidemiology, German Center for Vertigo and Balance Disorders, LMU Munich, Marchioninistraße, Munich.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Grill', 'Affiliation': 'Institute for Medical Information Processing, Biometrics and Epidemiology, German Center for Vertigo and Balance Disorders, LMU Munich, Marchioninistraße, Munich.'}, {'ForeName': 'Carolin', 'Initials': 'C', 'LastName': 'Melcher', 'Affiliation': 'Department of Orthopaedics, Physical Medicine and Rehabilitation, University, Hospital, LMU Munich, Marchioninistraße.'}, {'ForeName': 'Christof', 'Initials': 'C', 'LastName': 'Birkenmaier', 'Affiliation': 'Department of Orthopaedics, Physical Medicine and Rehabilitation, University, Hospital, LMU Munich, Marchioninistraße.'}, {'ForeName': 'Volkmar', 'Initials': 'V', 'LastName': 'Jansson', 'Affiliation': 'Department of Orthopaedics, Physical Medicine and Rehabilitation, University, Hospital, LMU Munich, Marchioninistraße.'}, {'ForeName': 'Bernd', 'Initials': 'B', 'LastName': 'Wegener', 'Affiliation': 'Department of Orthopaedics, Physical Medicine and Rehabilitation, University, Hospital, LMU Munich, Marchioninistraße.'}]",Clinical spine surgery,['10.1097/BSD.0000000000000777'] 1092,31149873,Influence of the position of charcoal air-filtration canisters on the efficacy of waste isoflurane scavenging as assessed in a randomized experiment.,OBJECTIVE To determine whether the position or elevation of charcoal air-filtration canisters would impact efficacy of waste anesthetic gas (WAG) scavenging. DESIGN Randomized experiment. SAMPLE 2 types of bottom-vented and 1 type of top-vented charcoal air-filtration canisters (n = 8 of each canister type/evaluation session). PROCEDURES Canisters were evaluated in a vertical or horizontal position at both low and high isoflurane gas flow rates in a modified Bain nonrebreathing circuit. Waste anesthetic gas concentrations were measured 2.54 cm from canister exhaust ports with an ambient air analyzer every 30 seconds for a maximum of 15 min/experimental condition. One type of bottom-vented canister was tested in a vertical position elevated above or suspended below the vaporizer at a high isoflurane flow rate and then a standard maintenance flow rate. RESULTS Position had no significant effect on WAG emission by any canister type at low isoflurane flow rates. Horizontally positioned bottom-vented canisters at the high isoflurane flow rate emitted significantly more WAG than vertically positioned canisters. Horizontally positioned top-vented canisters at high flow rates emitted significantly more WAG than vertically positioned canisters at the final 15-minute time point only. Cannister types differed significantly in intercanister variability. Canister elevation relative to the vaporizer had no impact on WAG scavenging efficacy. CONCLUSIONS AND CLINICAL RELEVANCE Findings suggested that charcoal air-filtration canisters should be used in a vertical position when anesthetizing animals with the anesthetic delivery system used in this study.,2019,Horizontally positioned top-vented canisters at high flow rates emitted significantly more WAG than vertically positioned canisters at the final 15-minute time point only.,[],['charcoal air-filtration canisters'],"['Waste anesthetic gas concentrations', 'WAG emission']",[],"[{'cui': 'C0007955', 'cui_str': 'Charcoal'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0016107', 'cui_str': 'Filtration - action'}, {'cui': 'C0336640', 'cui_str': 'Canister'}]","[{'cui': 'C0235394', 'cui_str': 'Wasting'}, {'cui': 'C0242902', 'cui_str': 'Anesthetic Gases'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0233929', 'cui_str': 'Emission (finding)'}]",,0.0220005,Horizontally positioned top-vented canisters at high flow rates emitted significantly more WAG than vertically positioned canisters at the final 15-minute time point only.,"[{'ForeName': 'Elizabeth S', 'Initials': 'ES', 'LastName': 'Moore', 'Affiliation': ''}, {'ForeName': 'Erin K', 'Initials': 'EK', 'LastName': 'Daugherity', 'Affiliation': ''}, {'ForeName': 'Bhupinder', 'Initials': 'B', 'LastName': 'Singh', 'Affiliation': ''}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Mooneyhan', 'Affiliation': ''}, {'ForeName': 'Teresa J', 'Initials': 'TJ', 'LastName': 'Porri', 'Affiliation': ''}, {'ForeName': 'Wendy O', 'Initials': 'WO', 'LastName': 'Williams', 'Affiliation': ''}]",Journal of the American Veterinary Medical Association,['10.2460/javma.254.12.1459'] 1093,30320302,Economic Evaluation of the Home Blood Pressure Telemonitoring and Pharmacist Case Management to Control Hypertension (Hyperlink) Trial.,"Background Pharmacist-managed (team-based) care for hypertension with home blood pressure monitoring support interventions have been widely studied and shown to be effective in improving rates of hypertension control and lowering blood pressure; however, few studies have evaluated the economic considerations related to bringing these programs into usual practice. Objective To analyze the economic outcomes of the Blood Pressure Telemonitoring and Pharmacist Management on Blood Pressure (Hyperlink) study, a cluster randomized controlled trial which used home blood pressure telemonitoring and pharmacist case management to achieve better blood pressure control in patients with uncontrolled hypertension. Methods A prospective analysis compared differences in medical costs and encounters in the Hyperlink telemonitoring intervention and usual care groups in the 12 months pre- and post-enrollment using medical and pharmacy insurance claims from a health care sector perspective. Generalized estimating equation models were used to estimate differences between groups over time. These results, combined with previously published prospective study results on intervention costs and blood pressure outcomes, were used to estimate cost-effectiveness measures for blood pressure control and reduction. Findings Total medical costs in the intervention group were lower compared with the usual care group by an average of $281 per person, but this difference was not statistically significant. Clinic-based office visit, radiology, pharmacy, and hospital costs were also non-significantly lower in the intervention group. Statistically significant differences were found in lipid-related laboratory costs (higher) and in hypertension- (higher) and lipid-related (lower) pharmacy costs. Patterns in medical costs were similar for medical encounters. On average, the intervention cost $7337 per person achieving hypertension control and $139 or $265 per mm Hg reduction in systolic or diastolic blood pressure, respectively. Conclusions Home blood pressure monitoring and pharmacist case management to improve hypertension care can be implemented without increasing, and potentially reducing, overall medical care costs.",2018,"Clinic-based office visit, radiology, pharmacy, and hospital costs were also non-significantly lower in the intervention group.",['patients with uncontrolled hypertension'],"['home blood pressure telemonitoring and pharmacist case management', 'Blood Pressure Telemonitoring and Pharmacist Management', '\n\n\nPharmacist-managed (team-based) care for hypertension with home blood pressure monitoring support interventions']","['blood pressure control and reduction', 'systolic or diastolic blood pressure', 'lipid-related laboratory costs (higher) and in hypertension- (higher) and lipid-related (lower) pharmacy costs', 'Total medical costs', 'Clinic-based office visit, radiology, pharmacy, and hospital costs']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1868885', 'cui_str': 'Uncontrolled hypertension'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0031323', 'cui_str': 'Pharmacist'}, {'cui': 'C0085971', 'cui_str': 'Case Management'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C1449681', 'cui_str': 'Blood Pressure Monitoring, Home'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}]","[{'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0031322', 'cui_str': 'Pharmacies'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0028900', 'cui_str': 'Office Visits'}, {'cui': 'C0034599', 'cui_str': 'Radiology'}, {'cui': 'C0206174', 'cui_str': 'Hospital Costs'}]",,0.0354694,"Clinic-based office visit, radiology, pharmacy, and hospital costs were also non-significantly lower in the intervention group.","[{'ForeName': 'Steven P', 'Initials': 'SP', 'LastName': 'Dehmer', 'Affiliation': 'HealthPartners Institute, Minneapolis, MN.'}, {'ForeName': 'Michael V', 'Initials': 'MV', 'LastName': 'Maciosek', 'Affiliation': 'HealthPartners Institute, Minneapolis, MN.'}, {'ForeName': 'Nicole K', 'Initials': 'NK', 'LastName': 'Trower', 'Affiliation': 'HealthPartners Institute, Minneapolis, MN.'}, {'ForeName': 'Stephen E', 'Initials': 'SE', 'LastName': 'Asche', 'Affiliation': 'HealthPartners Institute, Minneapolis, MN.'}, {'ForeName': 'Anna R', 'Initials': 'AR', 'LastName': 'Bergdall', 'Affiliation': 'HealthPartners Institute, Minneapolis, MN.'}, {'ForeName': 'Rachel A', 'Initials': 'RA', 'LastName': 'Nyboer', 'Affiliation': 'HealthPartners Institute, Minneapolis, MN.'}, {'ForeName': 'Patrick J', 'Initials': 'PJ', 'LastName': ""O'Connor"", 'Affiliation': 'HealthPartners Institute, Minneapolis, MN.'}, {'ForeName': 'Pamela A', 'Initials': 'PA', 'LastName': 'Pawloski', 'Affiliation': 'HealthPartners Institute, Minneapolis, MN.'}, {'ForeName': 'JoAnn M', 'Initials': 'JM', 'LastName': 'Sperl-Hillen', 'Affiliation': 'HealthPartners Institute, Minneapolis, MN.'}, {'ForeName': 'Beverly B', 'Initials': 'BB', 'LastName': 'Green', 'Affiliation': 'Kaiser Permanente Washington Health Research Institute, Seattle, WA.'}, {'ForeName': 'Karen L', 'Initials': 'KL', 'LastName': 'Margolis', 'Affiliation': 'HealthPartners Institute, Minneapolis, MN.'}]",Journal of the American College of Clinical Pharmacy : JACCP,['10.1002/jac5.1001'] 1094,30953835,"Receptor-Enriched Analysis of functional connectivity by targets (REACT): A novel, multimodal analytical approach informed by PET to study the pharmacodynamic response of the brain under MDMA.","One of the main limitations of pharmacological fMRI is its inability to provide a molecular insight into the main effect of compounds, leaving an open question about the relationship between drug effects and haemodynamic response. The aim of this study is to investigate the acute effects of 3,4-methylenedioxymethamphetamine (MDMA) on functional connectivity (FC) using a novel multimodal method (Receptor-Enriched Analysis of functional Connectivity by Targets - REACT). This approach enriches the resting state (rs-)fMRI analysis with the molecular information about the distribution density of serotonin receptors in the brain, given the serotonergic action of MDMA. Twenty healthy subjects participated in this double-blind, placebo-controlled, crossover study. A high-resolution in vivo atlas of four serotonin receptors (5-HT 1A , 5-HT 1B , 5-HT 2A , and 5-HT 4 ) and its transporter (5-HTT) was used as a template in a two-step multivariate regression analysis to estimate the spatial maps reflecting the whole-brain connectivity behaviour related to each target under placebo and MDMA. Results showed that the networks exhibiting significant changes after MDMA administration are the ones informed by the 5-HTT and 5-HT 1A distribution density maps, which are the main targets of this compound. Changes in the 5-HT 1A -enriched functional maps were also associated with the pharmacokinetic levels of MDMA and MDMA-induced FC changes in the 5-HT 2A -enriched maps correlated with the spiritual experience subscale of the Altered States of Consciousness Questionnaire. By enriching the rs-fMRI analysis with molecular data of voxel-wise distribution of the serotonin receptors across the brain, we showed that MDMA effects on FC can be understood through the distribution of its main targets. This result supports the ability of this method to characterise the specificity of the functional response of the brain to MDMA binding to serotonergic receptors, paving the way to the definition of a new fingerprint in the characterization of new compounds and potentially to a further understanding to the response to treatment.",2019,"Results showed that the networks exhibiting significant changes after MDMA administration are the ones informed by the 5-HTT and 5-HT 1A distribution density maps, which are the main targets of this compound.",['Twenty healthy subjects'],"['Receptor-Enriched Analysis of functional connectivity by targets (REACT', '3,4-methylenedioxymethamphetamine (MDMA', 'placebo']","['spiritual experience subscale of the Altered States of Consciousness Questionnaire', 'pharmacokinetic levels of MDMA and MDMA-induced FC changes', 'functional connectivity (FC']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0597357', 'cui_str': 'Receptor (substance)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C4224854', 'cui_str': 'React'}, {'cui': 'C0115471', 'cui_str': 'MDMA'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0150450', 'cui_str': 'Altered state of consciousness'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0115471', 'cui_str': 'MDMA'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}]",20.0,0.0445438,"Results showed that the networks exhibiting significant changes after MDMA administration are the ones informed by the 5-HTT and 5-HT 1A distribution density maps, which are the main targets of this compound.","[{'ForeName': 'Ottavia', 'Initials': 'O', 'LastName': 'Dipasquale', 'Affiliation': ""Department of Neuroimaging, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, United Kingdom. Electronic address: ottavia.dipasquale@kcl.ac.uk.""}, {'ForeName': 'Pierluigi', 'Initials': 'P', 'LastName': 'Selvaggi', 'Affiliation': ""Department of Neuroimaging, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, United Kingdom.""}, {'ForeName': 'Mattia', 'Initials': 'M', 'LastName': 'Veronese', 'Affiliation': ""Department of Neuroimaging, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, United Kingdom.""}, {'ForeName': 'Anthony S', 'Initials': 'AS', 'LastName': 'Gabay', 'Affiliation': ""Department of Neuroimaging, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, United Kingdom.""}, {'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Turkheimer', 'Affiliation': ""Department of Neuroimaging, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, United Kingdom.""}, {'ForeName': 'Mitul A', 'Initials': 'MA', 'LastName': 'Mehta', 'Affiliation': ""Department of Neuroimaging, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London, United Kingdom.""}]",NeuroImage,['10.1016/j.neuroimage.2019.04.007'] 1095,31006876,Impact of Teduglutide on Quality of Life Among Patients With Short Bowel Syndrome and Intestinal Failure.,"BACKGROUND Teduglutide reduces or eliminates parenteral support (PS) dependency in patients with short bowel syndrome (SBS). Recent post hoc analyses demonstrated that effects are correlated with baseline PS volume. We assessed the SBS-related quality-of-life (QoL) impact of teduglutide, particularly whether improvements are greater among subgroups achieving more PS volume reduction. METHODS Using phase 3 trial data of teduglutide in patients with SBS (NCT00798967), change in Short Bowel Syndrome-Quality of Life (SBS-QoL) scores from baseline were compared between teduglutide vs placebo in the overall population and subgroups classified by baseline PS volume requirement, disease etiology, and bowel anatomy. Generalized estimating equation models were fitted to assess impact of teduglutide on SBS-related QoL using data from all visits, adjusted for baseline characteristics. RESULTS Of 86 patients, 43 each were randomized to teduglutide or placebo (mean age: 51 vs 50 years, respectively). In adjusted analyses, teduglutide had a nonsignificant reduction (improvement) of -8.6 points (95% CI: 2.6 to -19.8) in SBS-QoL sum score from baseline to Week-24 vs placebo. The impact of teduglutide varied by subgroup. Patients treated with teduglutide experienced significantly greater reductions in SBS-QoL sum score at Week-24 vs placebo in 2 subgroups, ie, the third (highest) tertile baseline PS volume (-27.3, 95% CI: -50.8 to -3.7) and inflammatory bowel disease (IBD; -29.6, 95% CI: -46.3 to -12.9). Results were similar for SBS-QoL subscale and item scores. CONCLUSIONS The impact of teduglutide treatment on SBS-related QoL vs placebo varied among subgroups and was significant and most pronounced among patients with highest baseline PS volume requirement or IBD.",2020,"Patients treated with teduglutide experienced significantly greater reductions in SBS-QoL sum score at Week-24 vs placebo in 2 subgroups, ie, the third (highest) tertile baseline PS volume (-27.3, 95% CI: -50.8 to -3.7) and inflammatory bowel disease (IBD; -29.6, 95% CI: -46.3 to -12.9).","['patients with SBS', 'patients with short bowel syndrome (SBS', 'Of 86 patients, 43 each were randomized to teduglutide or', 'Patients With Short Bowel Syndrome and Intestinal Failure']","['teduglutide vs placebo', 'Teduglutide', 'placebo']","['SBS-QoL sum score', 'SBS-related quality-of-life (QoL) impact of teduglutide', 'Quality of Life', 'change in Short Bowel Syndrome-Quality of Life (SBS-QoL) scores', 'SBS-QoL subscale and item scores', 'inflammatory bowel disease']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0036992', 'cui_str': 'Short Bowel Syndrome'}, {'cui': 'C1530889', 'cui_str': 'teduglutide'}, {'cui': 'C0021853', 'cui_str': 'Intestines'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}]","[{'cui': 'C1530889', 'cui_str': 'teduglutide'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C1530889', 'cui_str': 'teduglutide'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0036992', 'cui_str': 'Short Bowel Syndrome'}, {'cui': 'C0559741', 'cui_str': 'Item score (qualifier value)'}, {'cui': 'C0021390', 'cui_str': 'Inflammatory Bowel Diseases'}]",,0.405789,"Patients treated with teduglutide experienced significantly greater reductions in SBS-QoL sum score at Week-24 vs placebo in 2 subgroups, ie, the third (highest) tertile baseline PS volume (-27.3, 95% CI: -50.8 to -3.7) and inflammatory bowel disease (IBD; -29.6, 95% CI: -46.3 to -12.9).","[{'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Chen', 'Affiliation': 'Shire Human Genetic Therapies, Inc. (a member of the Takeda group of companies), Cambridge, Massachusetts, USA.'}, {'ForeName': 'Fan', 'Initials': 'F', 'LastName': 'Mu', 'Affiliation': 'Analysis Group, Inc., Boston, Massachusetts, USA.'}, {'ForeName': 'Jipan', 'Initials': 'J', 'LastName': 'Xie', 'Affiliation': 'Analysis Group, Inc., Los Angeles, California, USA.'}, {'ForeName': 'Sneha S', 'Initials': 'SS', 'LastName': 'Kelkar', 'Affiliation': 'Analysis Group, Inc., New York, New York, USA.'}, {'ForeName': 'Clément', 'Initials': 'C', 'LastName': 'Olivier', 'Affiliation': 'Shire International GmbH (a member of the Takeda group of companies), Zug, Switzerland.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Signorovitch', 'Affiliation': 'Analysis Group, Inc., Boston, Massachusetts, USA.'}, {'ForeName': 'Palle B', 'Initials': 'PB', 'LastName': 'Jeppesen', 'Affiliation': 'Department of Medical Gastroenterology, Rigshospitalet, Copenhagen, Denmark.'}]",JPEN. Journal of parenteral and enteral nutrition,['10.1002/jpen.1588'] 1096,31012862,"Double-Blind, Single-Center, Randomized Three-Way Crossover Trial of Fitted, Thin, and Standard Condoms for Vaginal and Anal Sex: C-PLEASURE Study Protocol and Baseline Data.","BACKGROUND Male condoms are underused despite their ability to prevent transmission of HIV and other sexually transmitted infections. The perception of decreased sexual pleasure and poor condom fit are major contributors to condom nonuse. OBJECTIVE The purpose of this study was to compare event-level performance and pleasure using fitted, thin, and standard condoms among men who have sex with men (MSM) and men who have sex with women (MSW). We also sought to assess condom type preference. We present the study design and enrollment data from the trial. METHODS This study recruited sexually active men aged 18 to 54 years in Atlanta, Georgia, United States. We enrolled 252 MSM and 252 MSW in a double-blind, 3-way randomized crossover trial with conditions of fitted, thin, and standard condoms. A permuted block randomization scheme was used to assign each participant to the sequence in which they received each type of study condom. After a baseline screening and enrollment visit, randomized participants were followed for at least 6 and up to 12 weeks depending on their use of study condoms in each 2-week period between scheduled, in-person study visits. Participants were instructed to complete mobile-optimized coital logs as soon as possible after using condoms for anal or vaginal sex acts. The logs collected event-level pleasure and performance measures for the study condoms as well as other relevant data. A questionnaire was administered at the final study visit to assess overall study condom preference. RESULTS The study enrolled 252 MSM and 252 MSW, a total of 504 participants. MSM and MSW study arms were similar for a number of key traits including race and ethnicity, marital status, self-rated condom experience, and recent experience of condom failure. Men in the MSM arm were older, however, and fewer MSM were students. The majority of participants in both arms rated themselves as very experienced with using condoms, and the majority had used condoms recently. Over one-third of participants in each arm reported experiencing condom failure in the last 6 months. CONCLUSIONS This is the first condom trial to compare the performance of standard, thin, and fitted condoms and to use pleasure and preference as primary outcomes. Given the disparate impact of HIV on MSM, equal enrollment of MSM and MSW was a key feature of this study. Trial results may inform an FDA label indication for anal sex and provide new information regarding the relative performance of different types of condoms. TRIAL REGISTRATION ClinicalTrials.gov NCT02753842; https://clinicaltrials.gov/ct2/show/NCT02753842 (Archived by WebCite at http://www.webcitation.org/76RLTFyf0). INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID) DERR1-10.2196/12205.",2019,"MSM and MSW study arms were similar for a number of key traits including race and ethnicity, marital status, self-rated condom experience, and recent experience of condom failure.","['men who have sex with men (MSM) and men who have sex with women (MSW', 'sexually active men aged 18 to 54 years in Atlanta, Georgia, United States', 'The study enrolled 252 MSM and 252 MSW, a total of 504 participants']",[],"['experiencing condom failure', 'sexual pleasure']","[{'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0241028', 'cui_str': 'Sexually active (finding)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0017454', 'cui_str': 'Georgian S.S.R.'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]",[],"[{'cui': 'C0009653', 'cui_str': 'Condoms'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0679105', 'cui_str': 'Pleasure'}]",252.0,0.371439,"MSM and MSW study arms were similar for a number of key traits including race and ethnicity, marital status, self-rated condom experience, and recent experience of condom failure.","[{'ForeName': 'Aaron J', 'Initials': 'AJ', 'LastName': 'Siegler', 'Affiliation': 'Rollins School of Public Health, Department of Behavioral Sciences and Health Educaiton, Emory University, Atlanta, GA, United States.'}, {'ForeName': 'Elizabeth M', 'Initials': 'EM', 'LastName': 'Rosenthal', 'Affiliation': 'University at Albany School of Public Health, Department of Epidemiology, State University of New York, Albany, NY, United States.'}, {'ForeName': 'Patrick S', 'Initials': 'PS', 'LastName': 'Sullivan', 'Affiliation': 'Department of Epidemiology, Rollins School of Public Health, Emory University, Atlanta, GA, United States.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Ahlschlager', 'Affiliation': 'Department of Epidemiology, Rollins School of Public Health, Emory University, Atlanta, GA, United States.'}, {'ForeName': 'Colleen F', 'Initials': 'CF', 'LastName': 'Kelley', 'Affiliation': 'School of Medicine, Emory University, Atlanta, GA, United States.'}, {'ForeName': 'C Christina', 'Initials': 'CC', 'LastName': 'Mehta', 'Affiliation': 'Rollins School of Public Health, Department of Biostatistics and Bioinformatics, Emory University, Atlanta, GA, United States.'}, {'ForeName': 'Reneé H', 'Initials': 'RH', 'LastName': 'Moore', 'Affiliation': 'Rollins School of Public Health, Department of Biostatistics and Bioinformatics, Emory University, Atlanta, GA, United States.'}, {'ForeName': 'Eli S', 'Initials': 'ES', 'LastName': 'Rosenberg', 'Affiliation': 'University at Albany School of Public Health, Department of Epidemiology, State University of New York, Albany, NY, United States.'}, {'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'Cecil', 'Affiliation': 'TheyFit, LLC, Covington, GA, United States.'}]",JMIR research protocols,['10.2196/12205'] 1097,30711649,"Health-Related Quality of Life in KEYNOTE-010: a Phase II/III Study of Pembrolizumab Versus Docetaxel in Patients With Previously Treated Advanced, Programmed Death Ligand 1-Expressing NSCLC.","INTRODUCTION In the phase II/III KEYNOTE-010 study (ClinicalTrials.gov, NCT01905657), pembrolizumab significantly prolonged overall survival over docetaxel in patients with previously treated, programmed death ligand 1-expressing (tumor proportion score ≥ 1%), advanced NSCLC. Health-related quality of life (HRQoL) results are reported here. METHODS Patients were randomized 1:1:1 to pembrolizumab 2 or 10 mg/kg every 3 weeks or docetaxel 75 mg/m 2 every 3 weeks. HRQoL was assessed using European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLC) Core 30 (C30), EORTC QLQ-Lung Cancer 13 (LC13), and EuroQoL-5D. Key analyses included mean baseline-to-week-12 change in global health status (GHS)/quality of life (QoL) score, functioning and symptom domains, and time to deterioration in a QLQ-LC13 composite endpoint of cough, dyspnea, and chest pain. RESULTS Patient reported outcomes compliance was high across all three instruments. Pembrolizumab was associated with better QLQ-C30 GHS/QoL scores from baseline to 12 weeks than docetaxel, regardless of pembrolizumab dose or tumor proportion score status (not significant). Compared with docetaxel, fewer pembrolizumab-treated patients had ""deteriorated"" status and more had ""improved"" status in GHS/QoL. Nominally significant improvement was reported in many EORTC symptom domains with pembrolizumab, and nominally significant worsening was reported with docetaxel. Significant prolongation in true time to deterioration for the QLQ-LC13 composite endpoint emerged for pembrolizumab 10 mg/kg compared to docetaxel (nominal two-sided p = 0.03), but not for the 2-mg/kg dose. CONCLUSIONS These findings suggest that HRQoL and symptoms are maintained or improved to a greater degree with pembrolizumab than with docetaxel in this NSCLC patient population.",2019,"Significant prolongation in true time to deterioration for the QLQ-LC13 composite endpoint emerged for pembrolizumab 10 mg/kg compared to docetaxel (nominal two-sided p = 0.03), but not for the 2-mg/kg dose. ","['Patients With Previously Treated Advanced, Programmed Death Ligand 1-Expressing NSCLC', 'Patients', 'patients with previously treated, programmed death ligand 1-expressing (tumor proportion score ≥ 1%), advanced NSCLC']","['pembrolizumab 2 or 10 mg/kg every 3 weeks or docetaxel', 'docetaxel', 'Pembrolizumab Versus Docetaxel', 'Pembrolizumab', 'pembrolizumab']","['Core 30 (C30), EORTC QLQ-Lung Cancer 13 (LC13), and EuroQoL-5D', 'Cancer (EORTC', 'global health status (GHS)/quality of life (QoL) score, functioning and symptom domains, and time to deterioration in a QLQ-LC13 composite endpoint of cough, dyspnea, and chest pain', 'QLQ-C30 GHS/QoL scores', 'Health-Related Quality of Life', 'Health-related quality of life (HRQoL', 'Quality of Life Questionnaire (QLC', 'HRQoL', 'overall survival', ' status']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0023688', 'cui_str': 'Ligands'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]","[{'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}]","[{'cui': 'C0444669', 'cui_str': 'Core (qualifier value)'}, {'cui': 'C1306460', 'cui_str': 'Primary malignant neoplasm of lung'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C1456573', 'cui_str': 'Global Health'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0010200', 'cui_str': 'Complaining of cough (finding)'}, {'cui': 'C0013404', 'cui_str': 'Breathlessness'}, {'cui': 'C0008031', 'cui_str': 'Chest Pain'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",,0.0658424,"Significant prolongation in true time to deterioration for the QLQ-LC13 composite endpoint emerged for pembrolizumab 10 mg/kg compared to docetaxel (nominal two-sided p = 0.03), but not for the 2-mg/kg dose. ","[{'ForeName': 'Fabrice', 'Initials': 'F', 'LastName': 'Barlesi', 'Affiliation': 'Multidisciplinary Oncology and Therapeutic Innovations Department, Aix Marseille University, Assistance Publique Hôpitaux de Marseille, Marseille, France. Electronic address: Fabrice.Barlesi@ap-hm.fr.'}, {'ForeName': 'Edward B', 'Initials': 'EB', 'LastName': 'Garon', 'Affiliation': 'David Geffen School of Medicine at University of California, Los Angeles, Santa Monica, California.'}, {'ForeName': 'Dong-Wan', 'Initials': 'DW', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Seoul National University Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Enriqueta', 'Initials': 'E', 'LastName': 'Felip', 'Affiliation': ""Vall d'Hebron University Hospital and Vall d'Hebron Institute of Oncology, Barcelona, Spain.""}, {'ForeName': 'Ji-Youn', 'Initials': 'JY', 'LastName': 'Han', 'Affiliation': 'Division of Translational & Clinical Research, National Cancer Center (Korea), Goyang-si, Republic of Korea.'}, {'ForeName': 'Joo-Hang', 'Initials': 'JH', 'LastName': 'Kim', 'Affiliation': 'Department of Medical Oncology, CHA Bundang Medical Center, CHA University, Gyeonggi-do, Republic of Korea.'}, {'ForeName': 'Myung-Ju', 'Initials': 'MJ', 'LastName': 'Ahn', 'Affiliation': 'Division of Hematology and Oncology, Department of Medicine, Samsung Medical Center, Seoul, Republic of Korea.'}, {'ForeName': 'Mary Jo', 'Initials': 'MJ', 'LastName': 'Fidler', 'Affiliation': 'Division of Hematology Oncology, Rush University Medical Center, Chicago, Ilinois.'}, {'ForeName': 'Matthew A', 'Initials': 'MA', 'LastName': 'Gubens', 'Affiliation': 'University of California, San Francisco, Helen Diller Family Comprehensive Cancer Center, San Francisco, California.'}, {'ForeName': 'Gilberto', 'Initials': 'G', 'LastName': 'de Castro', 'Affiliation': 'Clinical Oncology, Instituto do Cancer do Estado de Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Veerle', 'Initials': 'V', 'LastName': 'Surmont', 'Affiliation': 'Department of Respiratory Medicine/Thoracic Oncology, Universitar Ziekenhuis Ghent, Ghent, Belgium.'}, {'ForeName': 'Qiao', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'Biostatistics, Merck & Co., Inc., Kenilworth, New Jersey.'}, {'ForeName': 'Anne C', 'Initials': 'AC', 'LastName': 'Deitz', 'Affiliation': 'Center for Observational and Real-World Evidence, Merck & Co., Inc., Kenilworth, New Jersey.'}, {'ForeName': 'Gregory M', 'Initials': 'GM', 'LastName': 'Lubiniecki', 'Affiliation': 'Department of Clinical Research, Merck & Co., Inc., Kenilworth, New Jersey.'}, {'ForeName': 'Roy S', 'Initials': 'RS', 'LastName': 'Herbst', 'Affiliation': 'Department of Medical Oncology, Yale School of Medicine, New Haven, Connecticut.'}]",Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer,['10.1016/j.jtho.2019.01.016'] 1098,31709423,Predicting Response to the Antidepressant Bupropion using Pretreatment fMRI.,"Major depressive disorder is a primary cause of disability in adults with a lifetime prevalence of 6-21% worldwide. While medical treatment may provide symptomatic relief, response to any given antidepressant is unpredictable and patient-specific. The standard of care requires a patient to sequentially test different antidepressants for 3 months each until an optimal treatment has been identified. For 30-40% of patients, no effective treatment is found after more than one year of this trial-and-error process, during which a patient may suffer loss of employment or marriage, undertreated symptoms, and suicidal ideation. This work develops a predictive model that may be used to expedite the treatment selection process by identifying for individual patients whether the patient will respond favorably to bupropion, a widely prescribed antidepressant, using only pretreatment imaging data. This is the first model to do so for individuals for bupropion. Specifically, a deep learning predictor is trained to estimate the 8-week change in Hamilton Rating Scale for Depression (HAMD) score from pretreatment task-based functional magnetic resonance imaging (fMRI) obtained in a randomized controlled antidepressant trial. An unbiased neural architecture search is conducted over 800 distinct model architecture and brain parcellation combinations, and patterns of model hyperparameters yielding the highest prediction accuracy are revealed. The winning model identifies bupropion-treated subjects who will experience remission with the number of subjects needed-to-treat (NNT) to lower morbidity of only 3.2 subjects. It attains a substantially high neuroimaging study effect size explaining 26% of the variance ( R 2 = 0.26) and the model predicts post-treatment change in the 52-point HAMD score with an RMSE of 4.71. These results support the continued development of fMRI and deep learning-based predictors of response for additional depression treatments.",2019,"For 30-40% of patients, no effective treatment is found after more than one year of this trial-and-error process, during which a patient may suffer loss of employment or marriage, undertreated symptoms, and suicidal ideation.",['adults with a lifetime prevalence of 6-21% worldwide'],['bupropion'],['Hamilton Rating Scale for Depression (HAMD) score'],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}]","[{'cui': 'C0085208', 'cui_str': 'Bupropion'}]","[{'cui': 'C4545802', 'cui_str': 'HAM-D (Hamilton Rating Scale for Depression) score'}]",800.0,0.0353977,"For 30-40% of patients, no effective treatment is found after more than one year of this trial-and-error process, during which a patient may suffer loss of employment or marriage, undertreated symptoms, and suicidal ideation.","[{'ForeName': 'Kevin P', 'Initials': 'KP', 'LastName': 'Nguyen', 'Affiliation': 'University of Texas Southwestern Medical Center.'}, {'ForeName': 'Cherise Chin', 'Initials': 'CC', 'LastName': 'Fatt', 'Affiliation': 'University of Texas Southwestern Medical Center.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Treacher', 'Affiliation': 'University of Texas Southwestern Medical Center.'}, {'ForeName': 'Cooper', 'Initials': 'C', 'LastName': 'Mellema', 'Affiliation': 'University of Texas Southwestern Medical Center.'}, {'ForeName': 'Madhukar H', 'Initials': 'MH', 'LastName': 'Trivedi', 'Affiliation': 'University of Texas Southwestern Medical Center.'}, {'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Montillo', 'Affiliation': 'University of Texas Southwestern Medical Center.'}]","Predictive intelligence in medicine : second International Workshop, PRIME 2019, held in Conjunction with MICCAI 2019, Shenzhen, China, October 13, 2019, Proceedings. PRIME (Workshop) (2nd : 2019 : Shenzhen Shi, China)",['10.1007/978-3-030-32281-6_6'] 1099,31725463,The Effect of Foregrounding Intended Use on Observers' Ratings and Comments in the Assessment of Clinical Competence.,"PURPOSE Some educational programs have adopted the premise that the same assessment can serve both formative and summative goals; however, how observers understand and integrate the intended uses of assessment may affect the way they execute the assessment task. The objective of this study was to explore the effect of foregrounding a different intended use (formative vs summative learner assessment) on observer contributions (ratings and comments). METHOD In this randomized, experimental, between-groups, mixed-methods study (May-September 2017), participants observed 3 prerecorded clinical performances under formative or summative assessment conditions. Participants rated performances using a global rating tool and provided comments. Participants were then asked to reconsider their ratings from the alternative perspective (from which they were originally blinded). They received the opportunity to alter their ratings and comments and to provide rationales for their decision to change or preserve their original ratings and comments. Outcomes included participant-observers' comments, ratings, changes to each, and stated rationales for changing or preserving their contributions. RESULTS Foregrounding different intended uses of assessment data for participant-observers did not result in differences in ratings, number or type of comments (both emphasized evaluative over constructive statements), or the ability to differentiate among performances. After adopting the alternative perspective, participant-observers made only small changes in ratings or comments. Participant-observers reported that they engage in the process in an evaluative manner despite different intended uses. CONCLUSIONS Foregrounding different intended uses for assessments did not result in significant systematic differences in the assessment data generated. Observers provided more evaluative than constructive statements overall, regardless of the intended use of the assessment. Future research is needed to explore whether these results hold in social/workplace-based contexts and how they might affect learners.",2020,"RESULTS Foregrounding different intended uses of assessment data for participant-observers did not result in differences in ratings, number or type of comments (both emphasized evaluative over constructive statements), or the ability to differentiate among performances.",[],[],"[""participant-observers' comments, ratings, changes to each, and stated rationales for changing or preserving contributions""]",[],[],"[{'cui': 'C0282411', 'cui_str': 'Commentary'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0728887', 'cui_str': 'Preserving (attribute)'}]",,0.0538927,"RESULTS Foregrounding different intended uses of assessment data for participant-observers did not result in differences in ratings, number or type of comments (both emphasized evaluative over constructive statements), or the ability to differentiate among performances.","[{'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Tavares', 'Affiliation': 'W. Tavares is assistant professor and scientist, The Wilson Centre, and Post-MD Education, Faculty of Medicine, University of Toronto, Toronto, Ontario, Canada; ORCID: https://orcid.org/0000-0001-8267-9448. M. Young is associate professor, Department of Medicine, McGill University, Montreal, Quebec, Canada; ORCID: https://orcid.org/0000-0002-2036-2119. G. Gauthier is adjunct professor, Medecine Interne, Université de Sherbrooke, Sherbrooke, Quebec, Canada; ORCID: https://orcid.org/0000-0001-7368-638X. C. St-Onge is professor, Department of Medicine, Faculty of Medicine and Health Sciences, Université de Sherbrooke, Sherbrooke, Quebec, Canada; ORCID: http://orcid.org/0000-0001-5313-0456.'}, {'ForeName': 'Meredith', 'Initials': 'M', 'LastName': 'Young', 'Affiliation': ''}, {'ForeName': 'Geneviève', 'Initials': 'G', 'LastName': 'Gauthier', 'Affiliation': ''}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'St-Onge', 'Affiliation': ''}]",Academic medicine : journal of the Association of American Medical Colleges,['10.1097/ACM.0000000000003076'] 1100,31869005,Between-Individual Differences in Baseline Well-Being and Emotion Regulation Strategy Use Moderate the Effect of a Self-Help Cognitive-Behavioral Intervention for Typical Adults.,"BACKGROUND Self-help interventions intended to help nonclinical individuals regulate their emotions can have important social benefits (i.e. mental disorder prevention, well-being promotion). However, their mean effect size on well-being is generally low, possibly because there are considerable between-individual differences in the response to these interventions. The present study examined whether individuals' baseline levels of emotional well-being and engagement in emotion regulation strategies moderate the effects on these same variables in a 4-week self-help cognitive-behavioral intervention intended for typical adults. METHODS Data were collected from 158 nonclinical French adults (n = 95 for the control group, n = 63 for the cognitive-behavioral group) using experience sampling. Emotional well-being was assessed, as well as the engagement in three emotion regulation strategies (i.e. cognitive reappraisal, problem solving, and appreciation). RESULTS As expected, the post-test scores on some variables were significantly predicted by the interactions between the intervention and the pre-test scores on these same variables. In particular, it was the participants with the most negative baseline levels (i.e. low emotional well-being, low engagement in appreciation) who benefitted most from the intervention. CONCLUSIONS Results are discussed in the light of current knowledge on between-individual differences in how individuals respond to interventions.",2019,"As expected, the post-test scores on some variables were significantly predicted by the interactions between the intervention and the pre-test scores on these same variables.","['Data were collected from 158 nonclinical French adults (n\xa0=\xa095 for the control group, n\xa0=\xa063 for the cognitive-behavioral group) using experience sampling', 'Typical Adults']",['Self-Help Cognitive-Behavioral Intervention'],[],"[{'cui': 'C1556084', 'cui_str': 'French (ethnic group)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4279973', 'cui_str': 'Experience Sampling'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}]",[],,0.0158524,"As expected, the post-test scores on some variables were significantly predicted by the interactions between the intervention and the pre-test scores on these same variables.","[{'ForeName': 'Jean-Baptiste', 'Initials': 'JB', 'LastName': 'Pavani', 'Affiliation': 'Center for Research on the Psychology of Cognition, Language and Emotion (PsyCLE), Aix Marseille University, Aix en Provence, France.'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Berna', 'Affiliation': ""Cognitive and Affective Sciences Laboratory (SCALab), University of Lille 3-CNRS, Villeneuve d'Ascq, France.""}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Andreotti', 'Affiliation': ""Cognitive and Affective Sciences Laboratory (SCALab), University of Lille 3-CNRS, Villeneuve d'Ascq, France.""}, {'ForeName': 'Theo', 'Initials': 'T', 'LastName': 'Guiller', 'Affiliation': 'Center for Research on the Psychology of Cognition, Language and Emotion (PsyCLE), Aix Marseille University, Aix en Provence, France.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Antoine', 'Affiliation': ""Cognitive and Affective Sciences Laboratory (SCALab), University of Lille 3-CNRS, Villeneuve d'Ascq, France.""}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Dauvier', 'Affiliation': 'Center for Research on the Psychology of Cognition, Language and Emotion (PsyCLE), Aix Marseille University, Aix en Provence, France.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Congard', 'Affiliation': 'Pays de la Loire Psychology Laboratory (LPPL), University of Nantes, Nantes, France.'}]",Applied psychology. Health and well-being,['10.1111/aphw.12189'] 1101,31004164,Prospective Memory in Service Members with Mild Traumatic Brain Injury.,"INTRODUCTION Prospective memory (PM) is the ability to remember the intention to perform an action in the future. Following mild traumatic brain injury (mTBI), the brain structures supporting such PM may be compromised. PM is essential for remembering activities specific to TBI survivors that promote recovery, such as following doctors' orders, taking necessary medications, completing physical rehabilitation exercises, and maintaining supportive social relationships. Since the year 2000, more than 315,897 US Service Members are reported to have sustained an mTBI1, yet little has been done to address possible PM concerns. Therefore, identifying impaired PM and interventions that may ameliorate such deficits is important. The primary aim of this study was to determine whether task encoding using implementation intentions leads to better PM performance than encoding using rote rehearsal in Service Members with mTBI (n = 35) or with bodily injuries but no TBI (n = 8) at baseline and 6 months later. MATERIALS AND METHOD Participants were randomized to one of the two encoding conditions. They were asked to remember to complete a series of four tasks over the course of a 2-hour event-related potential session and to contact a staff member during a specified 2-hour window later that day. PM performance was assessed based on completion of each task at the appropriate time. IRB approval was obtained from The Catholic University of America, Walter Reed National Military Medical Center, and Ft. Belvoir Community Hospital. RESULTS Service Members with mTBI using implementation intentions outperformed those using rote rehearsal. The effect of injury type and the interaction between encoding condition and injury type did not yield differences that were statistically significant. CONCLUSIONS The results suggest that implementation intentions may be a useful PM remediation strategy for those who have sustained mTBI. Future research should validate these findings in a larger sample.",2019,"The effect of injury type and the interaction between encoding condition and injury type did not yield differences that were statistically significant. ","['Service Members with Mild Traumatic Brain Injury', 'Service Members with mTBI (n = 35) or with bodily injuries but no TBI (n = 8) at baseline and 6 months later', 'Participants']",[],['PM performance'],"[{'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C3508472', 'cui_str': 'Mild Traumatic Brain Injury'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]",[],[],,0.0554493,"The effect of injury type and the interaction between encoding condition and injury type did not yield differences that were statistically significant. ","[{'ForeName': 'Jill R', 'Initials': 'JR', 'LastName': 'Settle', 'Affiliation': ""Department of Psychology, The Catholic University of America, O'Boyle Hall Room 314, Washington, DC 20064.""}, {'ForeName': 'Deborah M', 'Initials': 'DM', 'LastName': 'Clawson', 'Affiliation': ""Department of Psychology, The Catholic University of America, O'Boyle Hall Room 314, Washington, DC 20064.""}, {'ForeName': 'Marc M', 'Initials': 'MM', 'LastName': 'Sebrechts', 'Affiliation': ""Department of Psychology, The Catholic University of America, O'Boyle Hall Room 314, Washington, DC 20064.""}, {'ForeName': 'Louis M', 'Initials': 'LM', 'LastName': 'French', 'Affiliation': 'National Intrepid Center of Excellence, 4860 South Palmer Road, Bethesda, MD 20889.'}, {'ForeName': 'Adreanna T', 'Initials': 'AT', 'LastName': 'Massey Watts', 'Affiliation': 'Department of Psychology, University of Maryland, Biology-Psychology Building, College Park, MD 20742.'}, {'ForeName': 'Connie C', 'Initials': 'CC', 'LastName': 'Duncan', 'Affiliation': 'Department of Psychiatry, Uniformed Services University of the Health Sciences, 4301 Jones Bridge Road, Bethesda, MD 20814.'}]",Military medicine,['10.1093/milmed/usz062'] 1102,30887570,"A randomized, controlled, phase II clinical trial of β-D-mannuronic acid (M2000) in pre-surgical breast cancer patients at early stage (T1-T2).","Following the potent efficacy of β-D-Mannuronic acid in a breast cancer murine model, we evaluated the efficacy of this novel non-steroidal anti-inflammatory drug in breast cancer patients in the present clinical trial. The study was an 8-week randomized, controlled, phase II clinical trial (IRCT: 2017012213739N7 (in 48 pre-surgical breast cancer patients. Patients who had breast cancer at early stage, with invasive ductal carcinoma, were placed on a waiting-list for surgery and were allocated to the study. β-D-Mannuronic was administrated at a dose of two capsules (1000 mg/d) orally during a period of 8 weeks. The end point of this study was when the patients were admitted for surgery. Moreover, the patients' well-being status was followed up on for safety. There were no statistically significant differences between treatment and non-treatment groups at baseline. β-D-Mannuronic acid therapy, from 20 patients, showed that in one patient (5%) tumour size was decreased; in five patients (25%) tumour growth was stopped; and in 14 patients (70%) the growth rate in the treatment group did not show significant change, compared to the non-treatment group. Evaluation of two tumour markers (carcinoembryonic antigen and cancer antigen 15-3) showed that there was no significant difference between before and after treatment. Although the use of some non-steroidal anti-inflammatory drugs in a long time period has shown a prophylactic effect in breast cancer, their therapeutic efficacy in a short time period is unknown, whereas treatment with β-D-Mannuronic acid during 8 weeks could show 30% therapeutic effects in pre-surgical breast cancer patients.",2019,There were no statistically significant differences between treatment and non-treatment groups at baseline.,"['breast cancer patients', '48 pre-surgical breast cancer patients', 'pre-surgical breast cancer patients', 'Patients who had breast cancer at early stage, with invasive ductal carcinoma, were placed on a waiting-list for surgery and were allocated to the study', 'patients were admitted for surgery', 'pre-surgical breast cancer patients at early stage (T1-T2']","['β-D-Mannuronic acid therapy', 'β-D-Mannuronic acid', 'β-D-mannuronic acid (M2000']","['growth rate', 'tumour size']","[{'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C2363430', 'cui_str': 'Early stage (qualifier value)'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C1176475', 'cui_str': 'Ductal Carcinoma'}, {'cui': 'C1704765', 'cui_str': 'Place - dosing instruction imperative'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0162988', 'cui_str': 'mannuronic acid'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0449249', 'cui_str': 'Growth rate (attribute)'}, {'cui': 'C0475440', 'cui_str': 'Tumor size'}]",,0.0271977,There were no statistically significant differences between treatment and non-treatment groups at baseline.,"[{'ForeName': 'Sarvenaz', 'Initials': 'S', 'LastName': 'Kashefi', 'Affiliation': 'Department of Immunology, School of Public Health, Tehran University of Medical Science, Tehran, Iran.'}, {'ForeName': 'Ramesh', 'Initials': 'R', 'LastName': 'Omranipour', 'Affiliation': 'Breast Disease Research Centre (BDRC), Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Habibollah', 'Initials': 'H', 'LastName': 'Mahmoodzadeh', 'Affiliation': 'Department of Surgical Oncology, Tehran University of Medical Science, Tehran, Iran.'}, {'ForeName': 'Hamid', 'Initials': 'H', 'LastName': 'Ahmadi', 'Affiliation': 'Breast Disease Research Centre (BDRC), Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Afsaneh', 'Initials': 'A', 'LastName': 'Alikhassi', 'Affiliation': 'Department of Radiology, Faculty of Medicine, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mostafa', 'Initials': 'M', 'LastName': 'Hosseini', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Salvatore', 'Initials': 'S', 'LastName': 'Cuzzocrea', 'Affiliation': 'Department of Chemical, Biological, Pharmaceutical and Environmental Sciences, University of Messina, Messina, Italy.'}, {'ForeName': 'Bernd H A', 'Initials': 'BHA', 'LastName': 'Rehm', 'Affiliation': 'Centre for Cell Factories and Biopolymers, Griffith Institute for Drug Discovery, Griffith University, Nathan, Queensland, Australia.'}, {'ForeName': 'Hidenori', 'Initials': 'H', 'LastName': 'Matsuo', 'Affiliation': 'National Hospital Organization, Nagasaki National Hospital, Nagasaki, Japan.'}, {'ForeName': 'Abbas', 'Initials': 'A', 'LastName': 'Mirshafiey', 'Affiliation': 'Department of Immunology, School of Public Health, Tehran University of Medical Science, Tehran, Iran.'}]",Clinical and experimental pharmacology & physiology,['10.1111/1440-1681.13086'] 1103,31025894,"Effect of Curcumin Supplementation on Exercise-Induced Oxidative Stress, Inflammation, Muscle Damage, and Muscle Soreness.","Curcumin has been shown to reduce exercise-induced oxidative stress (OS) and inflammation. The purpose of this investigation was to examine the effects of curcumin supplementation on OS, inflammation, muscle damage, and muscle soreness. Nineteen males participated in a randomized, double-blinded, placebo-controlled trial to examine the effects of curcumin supplementation (1.5 g/day) compared to a placebo (PLA) following a muscle-damaging protocol (MDP) on OS, inflammation, muscle damage, and soreness. Participants were randomized to two groups, curcumin or placebo group. The MDP was performed before and after supplementation (28 days). Blood was sampled pre- and postexercise and 60 min, 24 h, and 48 h postexercise and analyzed for total antioxidant capacity (TAC), malondialdehyde (MDA), tumor necrosis factor alpha (TNF-α), and creatine kinase (CK). In addition, a visual analog scale (VAS) was used on each blood sample to measure perceived muscle soreness. After supplementation, curcumin significantly blunted CK levels (199.62 U/L) compared to the placebo (287.03 U/L), overall ( p  < 0.0001). In addition, curcumin resulted in decreased muscle soreness, overall (VAS scale 2.88), when compared to the placebo (VAS scale 3.36) ( p  = 0.0120). There were no differences found in TAC, TNF-α, or MDA. Curcumin may reduce muscle damage and perceived muscle soreness without negatively impacting a natural inflammatory response following exercise. Future research should investigate chronic curcumin supplementation and its mechanistic effects on muscle recovery from exercise.",2020,"After supplementation, curcumin significantly blunted CK levels (199.62 U/L) compared to the placebo (287.03 U/L), overall (p < 0.0001).",['Nineteen males'],"['placebo', 'curcumin supplementation', 'Curcumin Supplementation', 'curcumin or placebo', 'placebo (PLA']","['muscle soreness, overall (VAS scale 2.88', 'total antioxidant capacity (TAC), malondialdehyde (MDA), tumor necrosis factor alpha (TNF-α), and creatine kinase (CK', 'OS, inflammation, muscle damage, and soreness', 'visual analog scale (VAS', 'OS, inflammation, muscle damage, and muscle soreness', 'Exercise-Induced Oxidative Stress, Inflammation, Muscle Damage, and Muscle Soreness', 'TAC, TNF-α, or MDA', 'blunted CK levels']","[{'cui': 'C0450337', 'cui_str': '19 (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0010467', 'cui_str': 'Curcumin'}]","[{'cui': 'C0231528', 'cui_str': 'Muscle Pain'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0222045'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0201973', 'cui_str': 'Creatine kinase measurement (procedure)'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0410158', 'cui_str': 'Muscle damage'}, {'cui': 'C0234233', 'cui_str': 'Tenderness (finding)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0242606', 'cui_str': 'Oxidative Stress'}, {'cui': 'C3489891', 'cui_str': 'TAC(a)'}, {'cui': 'C0000379', 'cui_str': '1,3-Benzodioxole-5-ethanamine, alpha-methyl-'}, {'cui': 'C1997138', 'cui_str': 'Blunted'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",19.0,0.331652,"After supplementation, curcumin significantly blunted CK levels (199.62 U/L) compared to the placebo (287.03 U/L), overall (p < 0.0001).","[{'ForeName': 'Steven A Basham', 'Initials': 'SAB', 'LastName': 'Ms', 'Affiliation': 'Applied Physiology Lab, Department of Kinesiology, Mississippi State University, Starkville, MS, USA.'}, {'ForeName': 'Hunter S', 'Initials': 'HS', 'LastName': 'Waldman PhD', 'Affiliation': 'Applied Physiology Lab, Department of Kinesiology, Mississippi State University, Starkville, MS, USA.'}, {'ForeName': 'Ben M', 'Initials': 'BM', 'LastName': 'Krings PhD', 'Affiliation': 'Department of Health and Human Performance, University of Wisconsin-Platteville, Platteville, WI, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Lamberth PhD', 'Affiliation': 'Applied Physiology Lab, Department of Kinesiology, Mississippi State University, Starkville, MS, USA.'}, {'ForeName': 'JohnEric W', 'Initials': 'JW', 'LastName': 'Smith PhD', 'Affiliation': 'Applied Physiology Lab, Department of Kinesiology, Mississippi State University, Starkville, MS, USA.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'McAllister PhD', 'Affiliation': 'Department of Health and Human Performance, Texas State University, San Marcos, TX, USA.'}]",Journal of dietary supplements,['10.1080/19390211.2019.1604604'] 1104,31711874,A pilot study to examine the acceptability and health effects of electronic cigarettes in HIV-positive smokers.,"INTRODUCTION Some HIV-positive smokers report ambivalence about quitting. Switching to electronic cigarettes (ECs) may be a viable option to reduce the negative health effects for smokers who are unable or unwilling to quit smoking combustible cigarettes (CCs). This study examined the acceptability and health-related effects of ECs in HIV-positive smokers who were not seeking smoking cessation treatment. METHODS HIV-positive smokers (N = 19) were enrolled and followed for 12 weeks. Cartridge-based ECs were provided at baseline, and E-liquid was provided weekly for 8 weeks. At baseline, weeks 1-8, and week 12, EC and CC use, cardiopulmonary function, respiratory symptoms, and carbon monoxide (CO) levels were measured. RESULTS At week 8, cigarettes per day (CPD) were reduced by more than 80%, with reduction maintained at week 12 (p's < .001). Cigarette dependence scores were 40% lower at week 8 than at baseline (p <  .001). Seven (36.8%) participants reported transitioning completely from CCs to ECs. Mean CO decreased significantly from BL to week 8 (p < .05) and remained significantly lower at week 12 (p <  .001). Intention to quit increased significantly over time. CONCLUSIONS Switching from CCs to ECs in HIV-positive smokers who are not ready to quit smoking in the next 30 days appears to be feasible. Beneficial effects were seen, such as reduced CPD, reduced CO and CC dependence, and increased motivation to quit. ECs may be promising as a harm reduction approach among HIV-positive smokers who are unable or unwilling to quit smoking.",2020,Mean CO decreased significantly from BL to week 8 (p < .05) and remained significantly lower at week 12 (p <  .001).,"['smokers who are unable or unwilling to quit smoking combustible cigarettes (CCs', 'HIV-positive smokers who were not seeking smoking cessation treatment', 'HIV-positive smokers (N\u202f=\u202f19) were enrolled and followed for 12 weeks', 'HIV-positive smokers', 'HIV-positive smokers who are unable or unwilling to quit smoking']","['electronic cigarettes (ECs', 'electronic cigarettes', 'ECs']","['Cigarette dependence scores', 'Beneficial effects', 'reduced CPD, reduced CO and CC dependence, and increased motivation to quit', 'cardiopulmonary function, respiratory symptoms, and carbon monoxide (CO) levels', 'Mean CO', 'acceptability and health effects', 'Intention to quit increased significantly over time']","[{'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C1299582', 'cui_str': 'Unable'}, {'cui': 'C0558080', 'cui_str': 'Unwilling (finding)'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0019699', 'cui_str': 'HTLV-III Seroconversion'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C3849993', 'cui_str': 'Electronic Cigarettes'}]","[{'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0439857', 'cui_str': 'Patient dependence on (contextual qualifier) (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C2001794', 'cui_str': '(BMIM)(TFSI) cpd'}, {'cui': 'C0520939', 'cui_str': 'Increased motivation (finding)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0037090', 'cui_str': 'Signs and Symptoms, Respiratory'}, {'cui': 'C0007018', 'cui_str': 'Carbon Monoxide'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",,0.0650687,Mean CO decreased significantly from BL to week 8 (p < .05) and remained significantly lower at week 12 (p <  .001).,"[{'ForeName': 'Patricia A', 'Initials': 'PA', 'LastName': 'Cioe', 'Affiliation': 'Center for Alcohol and Addiction Studies, Department of Behavioral and Social Sciences, Brown University School of Public Health, Providence, RI, USA. Electronic address: Patricia_Cioe@brown.edu.'}, {'ForeName': 'Alana N', 'Initials': 'AN', 'LastName': 'Mercurio', 'Affiliation': 'Center for Alcohol and Addiction Studies, Department of Behavioral and Social Sciences, Brown University School of Public Health, Providence, RI, USA.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Lechner', 'Affiliation': 'Department of Psychological Sciences, Kent State University, Kent, OH, USA.'}, {'ForeName': 'Catherine C', 'Initials': 'CC', 'LastName': 'Costantino', 'Affiliation': 'Center for Alcohol and Addiction Studies, Department of Behavioral and Social Sciences, Brown University School of Public Health, Providence, RI, USA.'}, {'ForeName': 'Jennifer W', 'Initials': 'JW', 'LastName': 'Tidey', 'Affiliation': 'Center for Alcohol and Addiction Studies, Department of Behavioral and Social Sciences, Brown University School of Public Health, Providence, RI, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Eissenberg', 'Affiliation': 'Department of Psychology and Center for the Study of Tobacco Products, Virginia Commonwealth University, Richmond, VA, USA.'}, {'ForeName': 'Christopher W', 'Initials': 'CW', 'LastName': 'Kahler', 'Affiliation': 'Center for Alcohol and Addiction Studies, Department of Behavioral and Social Sciences, Brown University School of Public Health, Providence, RI, USA.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2019.107678'] 1105,30963544,Short duration of untreated psychosis enhances negative symptom remission in extended early intervention service for psychosis.,"OBJECTIVE To test whether duration of untreated psychosis (DUP) < 3 months, recommended by the World Health Organization/International Early Psychosis Association, enhances the effects of an extended early intervention service (EEIS) on symptom remission. METHOD We examined data from a randomized controlled trial in which patients who received 2 years of treatment in EIS for psychosis were subsequently randomized to either 3 years of EEIS or 3 years of regular care (RC). Using a DUP cut-off ≤ 12 weeks (approximately < 3 months), patients were split into two groups. Length of positive, negative and total symptom remission were the outcomes. RESULTS Patients (N = 217) were mostly male (68%) with schizophrenia spectrum disorder (65%); 108 (50%) received EEIS (58 had DUP ≤12 weeks; 50 had DUP >12 weeks). Interaction between treatment condition (EEIS vs. RC) and DUP cut-off ≤ 12 weeks was only significant in multiple linear regression model examining length of negative symptom remission as the outcome (adjusted β = 36.88 [SE = 15.88], t = 2.32, P = 0.02). EEIS patients with DUP ≤12 weeks achieved 25 more weeks of negative symptom remission than EEIS patients with DUP >12 weeks. CONCLUSION Having a short DUP may be critical in deriving long-term benefits from EIS for psychosis, including EEIS settings. This work empirically supports policy recommendations of reducing DUP <3 months.",2019,"EEIS patients with DUP ≤12 weeks achieved 25 more weeks of negative symptom remission than EEIS patients with DUP >12 weeks. ","['Patients (N\xa0=\xa0217) were mostly male (68%) with schizophrenia spectrum disorder (65%); 108 (50%) received', 'patients who received 2\xa0years of treatment in EIS for psychosis']","['EEIS or 3\xa0years of regular care (RC', 'EEIS']","['Length of positive, negative and total symptom remission', 'negative symptom remission']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4517646', 'cui_str': '217'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C4517530', 'cui_str': 'One hundred and eight'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0033975', 'cui_str': 'Psychoses'}]","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205272', 'cui_str': 'Regular (qualifier value)'}]","[{'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}]",217.0,0.0417296,"EEIS patients with DUP ≤12 weeks achieved 25 more weeks of negative symptom remission than EEIS patients with DUP >12 weeks. ","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Dama', 'Affiliation': 'Prevention and Early Intervention Program for Psychosis (PEPP-Montreal), Douglas Mental Health University Institute, Montreal, QC, Canada.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Shah', 'Affiliation': 'Department of Psychiatry, McGill University, Montreal, QC, Canada.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Norman', 'Affiliation': 'Departments of Psychiatry and Epidemiology & Biostatistics, Western University, London, ON, Canada.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Iyer', 'Affiliation': 'Department of Psychiatry, McGill University, Montreal, QC, Canada.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Joober', 'Affiliation': 'Department of Psychiatry, McGill University, Montreal, QC, Canada.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Schmitz', 'Affiliation': 'Department of Psychiatry, McGill University, Montreal, QC, Canada.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Abdel-Baki', 'Affiliation': 'Department of Psychiatry, Universite de Montreal, Montreal, QC, Canada.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Malla', 'Affiliation': 'Department of Psychiatry, McGill University, Montreal, QC, Canada.'}]",Acta psychiatrica Scandinavica,['10.1111/acps.13033'] 1106,30810079,"The Effect of Single-Dose Massage Session on Autonomic Activity, Mood, and Affective Responses in Major Depressive Disorder.","Background: Massage therapy (MT) is a holistic procedure that includes hand pressure (HP), therapeutic communication (TC), and attentive care (AC); together, these procedures could decrease symptoms of depression. Purpose: To study the influence of TC and AC during MT. Methods: Within-subject experimental design with counterbalancing order of treatment. Comparison analysis of the effect of a typical Swedish massage session (SM) with a ""sham"" massage (ShM; without HP) on the heart rate variability (HRV) mood and affective responses of patients with major depressive disorder ( N = 11). During the ShM, clay stones were randomly placed on the body, and the patients were informed about the (sham) therapeutic effect of stones. Findings: A main effect of time showed that after intervention, both SM and ShM increased the HRV (high-frequency power; F [1, 10] = 7.58, p = .02) and reduced scores for anxiety ( F [1, 10] = 37.57, p < .001), other feelings ( F [1, 10] = 22.64, p = .001), and physical sedation ( F [1, 10] = 10.72, p = .008). The SM was associated with more positive affective responses than ShM (qualitative analysis). Conclusions: AC and TC included in MT session improved mood and HRV in the absence of HP. Additional effect on affective responses was observed owing to the HP.",2019,"The SM was associated with more positive affective responses than ShM (qualitative analysis). ","['patients with major depressive disorder ( N = 11', 'Major Depressive Disorder']","['Massage therapy (MT', 'Single-Dose Massage Session', 'typical Swedish massage session (SM) with a ""sham"" massage (ShM; without HP']","['affective responses', 'physical sedation', 'reduced scores for anxiety', 'heart rate variability (HRV) mood and affective responses', 'positive affective responses', 'HRV', 'Autonomic Activity, Mood, and Affective Responses', 'mood and HRV']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}]","[{'cui': 'C3536731', 'cui_str': 'Massage Therapy'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0024875', 'cui_str': 'Massage'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}]","[{'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}]",11.0,0.0317225,"The SM was associated with more positive affective responses than ShM (qualitative analysis). ","[{'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Hohl', 'Affiliation': 'Federal University of Juiz de Fora.'}, {'ForeName': 'Andréa Camaz', 'Initials': 'AC', 'LastName': 'Deslandes', 'Affiliation': 'Federal University of Rio de Janeiro.'}, {'ForeName': 'Cláudia Helena Cerqueira', 'Initials': 'CHC', 'LastName': 'Mármora', 'Affiliation': 'Federal University of Juiz de Fora.'}]",Journal of holistic nursing : official journal of the American Holistic Nurses' Association,['10.1177/0898010119832493'] 1107,30990549,Effect of a Workplace Wellness Program on Employee Health and Economic Outcomes: A Randomized Clinical Trial.,"Importance Employers have increasingly invested in workplace wellness programs to improve employee health and decrease health care costs. However, there is little experimental evidence on the effects of these programs. Objective To evaluate a multicomponent workplace wellness program resembling programs offered by US employers. Design, Setting, and Participants This clustered randomized trial was implemented at 160 worksites from January 2015 through June 2016. Administrative claims and employment data were gathered continuously through June 30, 2016; data from surveys and biometrics were collected from July 1, 2016, through August 31, 2016. Interventions There were 20 randomly selected treatment worksites (4037 employees) and 140 randomly selected control worksites (28 937 employees, including 20 primary control worksites [4106 employees]). Control worksites received no wellness programming. The program comprised 8 modules focused on nutrition, physical activity, stress reduction, and related topics implemented by registered dietitians at the treatment worksites. Main Outcomes and Measures Four outcome domains were assessed. Self-reported health and behaviors via surveys (29 outcomes) and clinical measures of health via screenings (10 outcomes) were compared among 20 intervention and 20 primary control sites; health care spending and utilization (38 outcomes) and employment outcomes (3 outcomes) from administrative data were compared among 20 intervention and 140 control sites. Results Among 32 974 employees (mean [SD] age, 38.6 [15.2] years; 15 272 [45.9%] women), the mean participation rate in surveys and screenings at intervention sites was 36.2% to 44.6% (n = 4037 employees) and at primary control sites was 34.4% to 43.0% (n = 4106 employees) (mean of 1.3 program modules completed). After 18 months, the rates for 2 self-reported outcomes were higher in the intervention group than in the control group: for engaging in regular exercise (69.8% vs 61.9%; adjusted difference, 8.3 percentage points [95% CI, 3.9-12.8]; adjusted P = .03) and for actively managing weight (69.2% vs 54.7%; adjusted difference, 13.6 percentage points [95% CI, 7.1-20.2]; adjusted P = .02). The program had no significant effects on other prespecified outcomes: 27 self-reported health outcomes and behaviors (including self-reported health, sleep quality, and food choices), 10 clinical markers of health (including cholesterol, blood pressure, and body mass index), 38 medical and pharmaceutical spending and utilization measures, and 3 employment outcomes (absenteeism, job tenure, and job performance). Conclusions and Relevance Among employees of a large US warehouse retail company, a workplace wellness program resulted in significantly greater rates of some positive self-reported health behaviors among those exposed compared with employees who were not exposed, but there were no significant differences in clinical measures of health, health care spending and utilization, and employment outcomes after 18 months. Although limited by incomplete data on some outcomes, these findings may temper expectations about the financial return on investment that wellness programs can deliver in the short term. Trial Registration ClinicalTrials.gov Identifier: NCT03167658.",2019,"After 18 months, the rates for 2 self-reported outcomes were higher in the intervention group than in the control group: for engaging in regular exercise (69.8% vs 61.9%; adjusted difference, 8.3 percentage points [95% CI, 3.9-12.8]; adjusted P = .03) and for actively managing weight (69.2% vs 54.7%; adjusted difference, 13.6 percentage points [95% CI, 7.1-20.2]; adjusted P = .02).","['Among 32\u202f974 employees (mean [SD] age, 38.6 [15.2] years; 15\u202f272 [45.9%] women), the mean participation rate in surveys and screenings at intervention sites was 36.2% to 44.6% (n\u2009=\u20094037 employees) and at primary control sites was 34.4% to 43.0% (n\u2009=\u20094106 employees', '20 randomly selected treatment worksites (4037 employees) and 140 randomly selected control worksites (28\u202f937 employees, including 20 primary control worksites [4106 employees', '160 worksites from January 2015 through June 2016']","['multicomponent workplace wellness program', 'Workplace Wellness Program', 'Control worksites received no wellness programming', '8 modules focused on nutrition, physical activity, stress reduction, and related topics implemented by registered dietitians at the treatment worksites']","['prespecified outcomes: 27 self-reported health outcomes and behaviors (including self-reported health, sleep quality, and food choices), 10 clinical markers of health (including cholesterol, blood pressure, and body mass index), 38 medical and pharmaceutical spending and utilization measures, and 3 employment outcomes (absenteeism, job tenure, and job performance', 'rates for 2 self-reported outcomes', 'rates of some positive self-reported health behaviors', 'Employee Health and Economic Outcomes', 'clinical measures of health, health care spending and utilization, and employment outcomes', 'actively managing weight', 'engaging in regular exercise']","[{'cui': 'C0599987', 'cui_str': 'Employee (person)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0162579', 'cui_str': 'Job Site'}, {'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C4319554', 'cui_str': '160'}]","[{'cui': 'C0162579', 'cui_str': 'Job Site'}, {'cui': 'C0043113', 'cui_str': 'Wellness Programs'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C3542953', 'cui_str': 'Module (core metadata concept)'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C0334932', 'cui_str': 'Dietitian (general) (occupation)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0008963', 'cui_str': 'Markers, Clinical'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0042153', 'cui_str': 'use'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0014003', 'cui_str': 'Employment'}, {'cui': 'C0000849', 'cui_str': 'Absenteeism'}, {'cui': 'C0028811', 'cui_str': 'Occupations'}, {'cui': 'C3887623', 'cui_str': 'Job Performance'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0018687'}, {'cui': 'C0079272', 'cui_str': 'Employee Health'}, {'cui': 'C0013557', 'cui_str': 'economics'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married (finding)'}, {'cui': 'C0582191', 'cui_str': 'Regular exercise (observable entity)'}]",20.0,0.0438637,"After 18 months, the rates for 2 self-reported outcomes were higher in the intervention group than in the control group: for engaging in regular exercise (69.8% vs 61.9%; adjusted difference, 8.3 percentage points [95% CI, 3.9-12.8]; adjusted P = .03) and for actively managing weight (69.2% vs 54.7%; adjusted difference, 13.6 percentage points [95% CI, 7.1-20.2]; adjusted P = .02).","[{'ForeName': 'Zirui', 'Initials': 'Z', 'LastName': 'Song', 'Affiliation': 'Harvard Medical School, Massachusetts General Hospital, Boston.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Baicker', 'Affiliation': 'University of Chicago Harris School of Public Policy, Chicago, Illinois.'}]",JAMA,['10.1001/jama.2019.3307'] 1108,28634662,HIV Stigma and Substance Use Among HIV-Positive Russians with Risky Drinking.,"The link between HIV stigma with substance use is understudied. We characterized individuals with high HIV stigma and examined whether HIV stigma contributes to substance use among HIV-positive Russians reporting risky alcohol use. We analyzed data from HERMITAGE, a randomized controlled trial of 700 people living with HIV/AIDS (PLWHA) with past 6-month risky sex and risky alcohol use in St. Petersburg, Russia (2007-2011). Participants who were female and reported depressive symptoms and lower social support were more likely to endorse high HIV stigma (all p's < 0.001). In adjusted models, high HIV stigma was not significantly associated with the primary outcome unhealthy substance use and was not consistently associated with secondary substance use outcomes. Interventions to enhance social and mental health support for PLWHA, particularly women, may reduce stigma, though such reductions may not correspond to substantial decreases in substance use among this population.",2017,"In adjusted models, high HIV stigma was not significantly associated with the primary outcome unhealthy substance use and was not consistently associated with secondary substance use outcomes.","['700 people living with HIV/AIDS (PLWHA) with past 6-month risky sex and risky alcohol use in St. Petersburg, Russia (2007-2011', 'HIV-Positive Russians with Risky Drinking']",[],"['HIV Stigma and Substance Use', 'HIV stigma', 'depressive symptoms and lower social support', 'endorse high HIV stigma']","[{'cui': 'C4517862', 'cui_str': '700 (qualifier value)'}, {'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C1444637', 'cui_str': 'In the past'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C0035970', 'cui_str': 'Russian Federation (Europe)'}, {'cui': 'C0019699', 'cui_str': 'HTLV-III Seroconversion'}, {'cui': 'C0684271', 'cui_str': 'Drinkings'}]",[],"[{'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0277787', 'cui_str': 'Stigma (finding)'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0037438'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]",700.0,0.0704906,"In adjusted models, high HIV stigma was not significantly associated with the primary outcome unhealthy substance use and was not consistently associated with secondary substance use outcomes.","[{'ForeName': 'E Jennifer', 'Initials': 'EJ', 'LastName': 'Edelman', 'Affiliation': 'Yale University School of Medicine, PO Box 208025, New Haven, CT, 06520-8088, USA. ejennifer.edelman@yale.edu.'}, {'ForeName': 'Karsten', 'Initials': 'K', 'LastName': 'Lunze', 'Affiliation': 'Boston University School of Medicine and Boston Medical Center, Boston, MA, USA.'}, {'ForeName': 'Debbie M', 'Initials': 'DM', 'LastName': 'Cheng', 'Affiliation': 'Boston University School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Dmitry A', 'Initials': 'DA', 'LastName': 'Lioznov', 'Affiliation': 'First Pavlov State Medical University of St. Petersburg, St. Petersburg, Russian Federation.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Quinn', 'Affiliation': 'Boston University School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Natalia', 'Initials': 'N', 'LastName': 'Gnatienko', 'Affiliation': 'Boston University School of Medicine and Boston Medical Center, Boston, MA, USA.'}, {'ForeName': 'Carly', 'Initials': 'C', 'LastName': 'Bridden', 'Affiliation': 'Boston University School of Medicine and Boston Medical Center, Boston, MA, USA.'}, {'ForeName': 'Christine E', 'Initials': 'CE', 'LastName': 'Chaisson', 'Affiliation': 'Boston University School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Alexander Y', 'Initials': 'AY', 'LastName': 'Walley', 'Affiliation': 'Boston University School of Medicine and Boston Medical Center, Boston, MA, USA.'}, {'ForeName': 'Evgeny M', 'Initials': 'EM', 'LastName': 'Krupitsky', 'Affiliation': 'First Pavlov State Medical University of St. Petersburg, St. Petersburg, Russian Federation.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Raj', 'Affiliation': 'University of California - San Diego, San Diego, CA, USA.'}, {'ForeName': 'Jeffrey H', 'Initials': 'JH', 'LastName': 'Samet', 'Affiliation': 'Boston University School of Medicine and Boston Medical Center, Boston, MA, USA.'}]",AIDS and behavior,['10.1007/s10461-017-1832-4'] 1109,30977377,The value of prednisolone acetate provocative test before intravitreal triamcinolone acetonide injections.,"PURPOSE The aim of this study was to investigate the diagnostic value of a topical prednisolone acetate 1% provocative test for steroid-induced ocular hypertension before intravitreal triamcinolone acetonide injection. METHODS This is a prospective, single-center, randomized controlled study at Kasr El Aini Hospital, Cairo University. Patients scheduled for intravitreal triamcinolone acetonide were enrolled and randomly allocated in a ratio 2:1 to either Group A: received prednisolone acetate provocative test and those who did not develop SIOH proceeded with intravitreal triamcinolone acetonide or Group B: did not receive prednisolone acetate provocative test and proceeded directly to intravitreal triamcinolone acetonide. Intraocular pressures were measured weekly for 4 weeks following intravitreal triamcinolone acetonide. Steroid-induced ocular hypertension is defined as intraocular pressure increase of 5 mmHg or more from baseline after prednisolone acetate provocative test or intravitreal triamcinolone acetonide. RESULTS A total of 66 eyes (66 patients) were included. Of which, 10 eyes (23.8%) showed prednisolone acetate provocative test steroid-induced ocular hypertension during the 4-week period. Intravitreal triamcinolone acetonide steroid-induced ocular hypertension was less likely to develop in Group A (prednisolone acetate provocative test non-steroid-induced ocular hypertension, n = 32, 31.25%) than in group B (n = 24, 54.2%) (p = 0.006, odds ratio: 0.178, 95% CI: 0.53-0.596). Our test achieved a negative predictive value of 68.75%. CONCLUSION The topical prednisolone acetate provocative test may be a useful method to predict a steroid-induced ocular hypertension following intravitreal triamcinolone acetonide.",2020,"Intravitreal triamcinolone acetonide steroid-induced ocular hypertension was less likely to develop in Group A (prednisolone acetate provocative test non-steroid-induced ocular hypertension, n = 32, 31.25%) than in group B (n = 24, 54.2%) (p = 0.006, odds ratio: 0.178, 95% CI: 0.53-0.596).","['A total of 66 eyes (66 patients) were included', 'Kasr El Aini Hospital, Cairo University']","['triamcinolone acetonide', 'topical prednisolone acetate', 'prednisolone acetate provocative test', 'Intravitreal triamcinolone acetonide steroid', 'intravitreal triamcinolone acetonide', 'triamcinolone acetonide injections', 'prednisolone acetate provocative test and those who did not develop SIOH proceeded with intravitreal triamcinolone acetonide']","['ocular hypertension', 'Intraocular pressures', 'prednisolone acetate provocative test steroid-induced ocular hypertension']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}]","[{'cui': 'C0040866', 'cui_str': 'Triamcinolone Acetonide'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0071839', 'cui_str': 'prednisolone acetate'}, {'cui': 'C0201784', 'cui_str': 'Provocative test (procedure)'}, {'cui': 'C0038317', 'cui_str': 'Steroids'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}]","[{'cui': 'C0028840', 'cui_str': 'Ocular Hypertension'}, {'cui': 'C0021888', 'cui_str': 'Ocular Tension'}, {'cui': 'C0071839', 'cui_str': 'prednisolone acetate'}, {'cui': 'C0201784', 'cui_str': 'Provocative test (procedure)'}, {'cui': 'C0038317', 'cui_str': 'Steroids'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}]",,0.0141427,"Intravitreal triamcinolone acetonide steroid-induced ocular hypertension was less likely to develop in Group A (prednisolone acetate provocative test non-steroid-induced ocular hypertension, n = 32, 31.25%) than in group B (n = 24, 54.2%) (p = 0.006, odds ratio: 0.178, 95% CI: 0.53-0.596).","[{'ForeName': 'Aya Mohammed', 'Initials': 'AM', 'LastName': 'Saady', 'Affiliation': 'Department of Ophthalmology, Kasr El Aini Hospital, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Heba M', 'Initials': 'HM', 'LastName': 'Fouad', 'Affiliation': 'Department of Ophthalmology, Kasr El Aini Hospital, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Abdussalam M', 'Initials': 'AM', 'LastName': 'Abdullatif', 'Affiliation': 'Department of Ophthalmology, Kasr El Aini Hospital, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Youssef A H', 'Initials': 'YAH', 'LastName': 'Helmy', 'Affiliation': 'Department of Ophthalmology, Kasr El Aini Hospital, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Tamer A', 'Initials': 'TA', 'LastName': 'Macky', 'Affiliation': 'Department of Ophthalmology, Kasr El Aini Hospital, Cairo University, Cairo, Egypt.'}, {'ForeName': 'Khaled', 'Initials': 'K', 'LastName': 'Mansour', 'Affiliation': 'Department of Ophthalmology, Kasr El Aini Hospital, Cairo University, Cairo, Egypt.'}]",European journal of ophthalmology,['10.1177/1120672119842731'] 1110,30980514,Efficacy and Safety of Intravenous Golimumab Through One Year in Patients With Active Psoriatic Arthritis.,"OBJECTIVE The present study was undertaken to evaluate the safety and efficacy of intravenous (IV) golimumab in patients with active psoriatic arthritis (PsA) through 1 year. METHODS GO-VIBRANT was a phase III, randomized, placebo-controlled trial of 480 adults with active PsA. Patients were randomized to receive IV placebo (n = 239) or golimumab 2 mg/kg (n = 241) at weeks 0, 4, and every 8 weeks, with placebo crossover to golimumab at weeks 24, 28, and every 8 weeks thereafter. Efficacy through week 52 was assessed using the American College of Rheumatology (ACR) ≥20%, 50%, or 70% improvement criteria (ACR20/50/70), and the Psoriasis Area and Severity Index ≥75% improvement criteria (PASI75). Radiographic progression was measured using the PsA-modified Sharp/van der Heijde score (SHS). Adverse events (AEs) were monitored through week 60. RESULTS The primary and major secondary end points through week 24 were achieved. At week 52, 76.8% of patients in the golimumab group and 77.0% in the placebo-crossover group achieved an ACR20 response, 58.1% and 53.6%, respectively, achieved an ACR50 response, and 38.6% and 33.9%, respectively, achieved an ACR70 response. Among patients with ≥3% body surface area affected, 71.9% in the golimumab group and 60.6% in the placebo-crossover group achieved a PASI75 response at week 52. Mean change from baseline in total SHS at week 52 was -0.5 in the golimumab group and 0.8 in the placebo-crossover group. Through week 60, 50.9% of all golimumab-treated patients had ≥1 AE, and 5.2% had ≥1 serious AE. There were no opportunistic infections, 2 malignancies, and 1 death in patients treated with golimumab. CONCLUSION Sustained improvements in joint and skin disease in patients with PsA were maintained through 1 year in the GO-VIBRANT study. No new safety signals for IV golimumab were identified.",2020,"CONCLUSION Sustained improvements in joint and skin disease in patients with PsA were maintained through 1 year in the GO-VIBRANT study.","['Patients with Active Psoriatic Arthritis', 'patients with active psoriatic arthritis (PsA) through 1 year', '480 adults with active PsA. Patients', 'patients with PsA']","['intravenous golimumab', 'Intravenous Golimumab', 'placebo', 'intravenous placebo', 'placebo crossover to golimumab', 'golimumab']","['ACR70 response', 'Psoriasis Area and Severity Index (PASI75); radiographic progression', 'ACR criteria (ACR20/50/70), Health Assessment Questionnaire-Disability Index (HAQ-DI', 'ACR50 response', 'PASI75 response', 'total vdH-S score', 'Efficacy and Safety', 'Adverse events (AEs', 'joint and skin disease', 'ACR20 response']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0003872', 'cui_str': 'Psoriatic Arthropathy'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4319609', 'cui_str': '480'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0201544', 'cui_str': 'Prostate specific antigen measurement (procedure)'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C2353893', 'cui_str': 'golimumab'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0451208', 'cui_str': 'Health assessment questionnaire (assessment scale)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0102923', 'cui_str': 'HAQ'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0022417', 'cui_str': 'Joints'}, {'cui': 'C0037274', 'cui_str': 'Dermatoses'}]",480.0,0.512219,"CONCLUSION Sustained improvements in joint and skin disease in patients with PsA were maintained through 1 year in the GO-VIBRANT study.","[{'ForeName': 'M Elaine', 'Initials': 'ME', 'LastName': 'Husni', 'Affiliation': 'Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Arthur', 'Initials': 'A', 'LastName': 'Kavanaugh', 'Affiliation': 'University of California San Diego, La Jolla.'}, {'ForeName': 'Frederick', 'Initials': 'F', 'LastName': 'Murphy', 'Affiliation': 'Altoona Center for Clinical Research, Duncansville, Pennsylvania.'}, {'ForeName': 'Dmytro', 'Initials': 'D', 'LastName': 'Rekalov', 'Affiliation': 'Zaporizhzhia Regional Hospital, Zaporozhe, Ukraine.'}, {'ForeName': 'Diane D', 'Initials': 'DD', 'LastName': 'Harrison', 'Affiliation': 'Janssen Research & Development, Spring House, Pennsylvania.'}, {'ForeName': 'Lilianne', 'Initials': 'L', 'LastName': 'Kim', 'Affiliation': 'Janssen Research & Development, Spring House, Pennsylvania.'}, {'ForeName': 'Kim Hung', 'Initials': 'KH', 'LastName': 'Lo', 'Affiliation': 'Janssen Research & Development, Spring House, Pennsylvania.'}, {'ForeName': 'Jocelyn H', 'Initials': 'JH', 'LastName': 'Leu', 'Affiliation': 'Janssen Research & Development, Spring House, Pennsylvania.'}, {'ForeName': 'Elizabeth C', 'Initials': 'EC', 'LastName': 'Hsia', 'Affiliation': 'Janssen Research & Development, Spring House, Pennsylvania, and University of Pennsylvania, Philadelphia.'}]",Arthritis care & research,['10.1002/acr.23905'] 1111,31654818,The effect of steady-state CO 2 on regional brain blood flow responses to increases in blood pressure via the cold pressor test.,"The pressure-passive cerebrovasculature is affected by alterations in cerebral perfusion pressure (CPP) and arterial blood gases (e.g., pressure of arterial [Pa]CO 2 ), where acute changes in either stimulus can influence cerebral blood flow (CBF). The effect of superimposed increases in CPP at different levels of steady-state PaCO 2 on regional CBF regulation is unclear. In 17 healthy participants, we simultaneously recorded continuous heart rate (electrocardiogram), blood pressure (finometer), pressure of end-tidal CO 2 (P ET CO 2 ; gas analyzer), and middle (MCA) and posterior (PCA) cerebral artery blood velocity (CBV; transcranial Doppler ultrasound). Three separate CPTs were administered by passive immersion of both feet into 0-1 °C of ice water for 3-min under three randomized and coached steady-state P ET CO 2 conditions: normocapnia (room air), hypocapnia (-10 Torr; hyperventilation) and hypercapnia (+9 Torr; 5% inspired CO 2 ;). CBV responses were calculated as the absolute difference (∆) between baseline and mean MCAv and PCAv during the 3-min CPT. Both the ∆MCAv and ∆PCAv responses to the CPT were larger under hypercapnic conditions. The absolute ∆MCAv response was larger than the ∆PCAv during the CPT across all three CO 2 trials. Cerebrovascular CO 2 reactivity (CVR) was larger in the MCA than PCA in both CPT and baseline conditions, but there were no differences in CVR between CPT and baseline conditions. Our data indicate that (a) increases in CO 2 increases the CBV responses to a CPT, (b) the anterior cerebrovasculature is more responsive to a CPT-induced increases in MAP, and (c) although unchanged during a CPT, CVR is larger in the anterior cerebral circulation.",2019,"Cerebrovascular CO 2 reactivity (CVR) was larger in the MCA than PCA in both CPT and baseline conditions, but there were no differences in CVR between CPT and baseline conditions.",['17 healthy participants'],"['coached steady-state P ET CO 2 conditions: normocapnia (room air), hypocapnia (-10\u202fTorr; hyperventilation) and hypercapnia (+9\u202fTorr; 5% inspired CO 2 ']","['blood pressure', 'cerebral perfusion pressure (CPP) and arterial blood gases (e.g., pressure of arterial [Pa]CO 2 ', 'CBV responses', 'regional brain blood flow responses', 'CVR', 'continuous heart rate (electrocardiogram), blood pressure (finometer), pressure of end-tidal CO 2 (P ET CO 2 ; gas analyzer), and middle (MCA) and posterior (PCA) cerebral artery blood velocity (CBV; transcranial Doppler ultrasound', 'Cerebrovascular CO 2 reactivity (CVR', 'absolute ∆MCAv response', 'cerebral blood flow (CBF']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0557773', 'cui_str': 'Coach (physical object)'}, {'cui': 'C0205361', 'cui_str': 'Steady (qualifier value)'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0085383', 'cui_str': 'Hypocapnia'}, {'cui': 'C0439475', 'cui_str': 'torr (qualifier value)'}, {'cui': 'C0020578', 'cui_str': 'Hyperventilation'}, {'cui': 'C0020440', 'cui_str': 'Hypercapnia'}]","[{'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0428713', 'cui_str': 'Cerebral Perfusion Pressure'}, {'cui': 'C0150411', 'cui_str': 'Blood gases, arterial measurement (procedure)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0221464', 'cui_str': 'Arterial (qualifier value)'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow, function (observable entity)'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0475251', 'cui_str': 'Gas analyzer (physical object)'}, {'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C0149576', 'cui_str': 'Posterior Cerebral Artery'}, {'cui': 'C1531610', 'cui_str': 'Blood velocity'}, {'cui': 'C0442348', 'cui_str': 'Transcranial approach (qualifier value)'}, {'cui': 'C0162481', 'cui_str': 'Doppler Ultrasound'}, {'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}, {'cui': 'C0428714', 'cui_str': 'Cerebral Blood Flow'}]",17.0,0.0223771,"Cerebrovascular CO 2 reactivity (CVR) was larger in the MCA than PCA in both CPT and baseline conditions, but there were no differences in CVR between CPT and baseline conditions.","[{'ForeName': 'Brittney A', 'Initials': 'BA', 'LastName': 'Herrington', 'Affiliation': 'Department of Biology, Faculty of Science and Technology, Mount Royal University, Calgary, Canada.'}, {'ForeName': 'Scott F', 'Initials': 'SF', 'LastName': 'Thrall', 'Affiliation': 'Department of Biology, Faculty of Science and Technology, Mount Royal University, Calgary, Canada.'}, {'ForeName': 'Leah M', 'Initials': 'LM', 'LastName': 'Mann', 'Affiliation': 'Department of Biology, Faculty of Science and Technology, Mount Royal University, Calgary, Canada.'}, {'ForeName': 'Michael M', 'Initials': 'MM', 'LastName': 'Tymko', 'Affiliation': 'Centre for Heart, Lung and Vascular Health, University of British Columbia, British Columbia, Canada.'}, {'ForeName': 'Trevor A', 'Initials': 'TA', 'LastName': 'Day', 'Affiliation': 'Department of Biology, Faculty of Science and Technology, Mount Royal University, Calgary, Canada. Electronic address: tday@mtroyal.ca.'}]",Autonomic neuroscience : basic & clinical,['10.1016/j.autneu.2019.102581'] 1112,30985861,Assessment of Inpatient Time Allocation Among First-Year Internal Medicine Residents Using Time-Motion Observations.,"Importance The United States spends more than $12 billion annually on graduate medical education. Understanding how residents balance patient care and educational activities may provide insights into how the modern physician workforce is being trained. Objective To describe how first-year internal medicine residents (interns) allocate time while working on general medicine inpatient services. Design, Setting, and Participants Direct observational secondary analysis, including 6 US university-affiliated and community-based internal medicine programs in the mid-Atlantic region, of the Comparative Effectiveness of Models Optimizing Patient Safety and Resident Education (iCOMPARE) trial, a cluster-randomized trial comparing different duty-hour policies. A total of 194 weekday shifts were observed and time motion data were collected, sampled by daytime, nighttime, and call shifts in proportion to the distribution of shifts within each program from March 10 through May 31, 2016. Data were analyzed from June 1, 2016, through January 5, 2019. Main Outcomes and Measures Mean time spent in direct and indirect patient care, education, rounds, handoffs, and miscellaneous activities within a 24-hour period and in each of four 6-hour periods (morning, afternoon, evening, and night). Time spent multitasking, simultaneously engaged in combinations of direct patient care, indirect patient care, or education, and in subcategories of indirect patient care were tracked. Results A total of 80 interns (55% men; mean [SD] age, 28.7 [2.3] years) were observed across 194 shifts, totaling 2173 hours. A mean (SD) of 15.9 (0.7) hours of a 24-hour period (66%) was spent in indirect patient care, mostly interactions with the patient's medical record or documentation (mean [SD], 10.3 [0.7] hours; 43%). A mean (SD) of 3.0 (0.1) hours was spent in direct patient care (13%) and 1.8 (0.3) hours in education (7%). This pattern was consistent across the 4 periods of the day. Direct patient care and education frequently occurred when interns were performing indirect patient care. Multitasking with 2 or more indirect patient care activities occurred for a mean (SD) of 3.8 (0.4) hours (16%) of the day. Conclusions and Relevance This study's findings suggest that within these US teaching programs, interns spend more time participating in indirect patient care than interacting with patients or in dedicated educational activities. These findings provide an essential baseline measure for future efforts designed to improve the workday structure and experience of internal medicine trainees, without making a judgment on the current allocation of time. Trial Registration ClinicalTrials.gov identifier: NCT02274818.",2019,"This study's findings suggest that within these US teaching programs, interns spend more time participating in indirect patient care than interacting with patients or in dedicated educational activities.","['Participants\n\n\nDirect observational secondary analysis, including 6 US university-affiliated and community-based internal medicine programs in the mid-Atlantic region', 'A total of 80 interns (55% men; mean [SD] age, 28.7 [2.3] years) were observed across 194 shifts, totaling 2173 hours']",[],"['indirect patient care activities', 'time motion data', 'Measures\n\n\nMean time spent in direct and indirect patient care, education, rounds, handoffs, and miscellaneous activities within a 24-hour period and in each of four 6-hour periods (morning, afternoon, evening, and night', 'Time spent multitasking, simultaneously engaged in combinations of direct patient care, indirect patient care, or education, and in subcategories of indirect patient care']","[{'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0021782', 'cui_str': 'Internal Medicine'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0026053', 'cui_str': 'Middle Atlantic States'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3875135', 'cui_str': 'Observes (attribute)'}, {'cui': 'C0333051', 'cui_str': 'Shift (morphologic abnormality)'}, {'cui': 'C0439227', 'cui_str': 'hour (qualifier value)'}]",[],"[{'cui': 'C0439852', 'cui_str': 'Indirect (qualifier value)'}, {'cui': 'C0017313'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0687704', 'cui_str': 'Motions (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0205395', 'cui_str': 'Miscellaneous (qualifier value)'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C1292428', 'cui_str': '6 hours (qualifier value)'}, {'cui': 'C0332170', 'cui_str': 'Morning (qualifier value)'}, {'cui': 'C0439550', 'cui_str': 'Afternoon (qualifier value)'}, {'cui': 'C0587117', 'cui_str': 'Evening (qualifier value)'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married (finding)'}]",,0.0475539,"This study's findings suggest that within these US teaching programs, interns spend more time participating in indirect patient care than interacting with patients or in dedicated educational activities.","[{'ForeName': 'Krisda H', 'Initials': 'KH', 'LastName': 'Chaiyachati', 'Affiliation': 'Department of Medicine, Perelman School of Medicine at the University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Judy A', 'Initials': 'JA', 'LastName': 'Shea', 'Affiliation': 'Department of Medicine, Perelman School of Medicine at the University of Pennsylvania, Philadelphia.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Asch', 'Affiliation': 'Department of Medicine, Perelman School of Medicine at the University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Manqing', 'Initials': 'M', 'LastName': 'Liu', 'Affiliation': 'Department of Medicine, Perelman School of Medicine at the University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'Bellini', 'Affiliation': 'Department of Medicine, Perelman School of Medicine at the University of Pennsylvania, Philadelphia.'}, {'ForeName': 'C Jessica', 'Initials': 'CJ', 'LastName': 'Dine', 'Affiliation': 'Department of Medicine, Perelman School of Medicine at the University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Alice L', 'Initials': 'AL', 'LastName': 'Sternberg', 'Affiliation': 'Department of Epidemiology, Johns Hopkins University, Baltimore, Maryland.'}, {'ForeName': 'Yevgeniy', 'Initials': 'Y', 'LastName': 'Gitelman', 'Affiliation': 'Department of Medicine, Perelman School of Medicine at the University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Alyssa M', 'Initials': 'AM', 'LastName': 'Yeager', 'Affiliation': 'Department of Medicine, Yale-New Haven Hospital, New Haven, Connecticut.'}, {'ForeName': 'Jeremy M', 'Initials': 'JM', 'LastName': 'Asch', 'Affiliation': 'Department of Emergency Medicine, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Sanjay V', 'Initials': 'SV', 'LastName': 'Desai', 'Affiliation': 'Department of Medicine, Johns Hopkins University, Baltimore, Maryland.'}]",JAMA internal medicine,['10.1001/jamainternmed.2019.0095'] 1113,30957654,"""Sex Offender"" Versus ""Person"": The Influence of Labels on Willingness to Volunteer With People Who Have Sexually Abused.","The present study examined the effect of offense-based labels on community members' willingness to volunteer with people convicted for varying offenses and any priming effect of labeling language. Participants ( N = 310) were randomly assigned to a label condition or a neutral condition and completed an anonymous online survey about their willingness to volunteer with different groups. The labeling condition utilized labels (e.g., ""sex offenders,"" ""murderers""), whereas the control condition utilized neutral descriptors (e.g., ""people who have committed crimes of a sexual nature""). Overall, findings supported the hypothesis that offense-based labels were associated with less willingness to volunteer, with findings most pronounced for the ""sex offender"" and ""child sex offender"" labels. Participants in the labeling condition showed greater voluntary use of labels compared with neutral language and were more likely to use labels compared with participants in the neutral condition. Implications for influencing public opinion are discussed.",2020,Participants in the labeling condition showed greater voluntary use of labels compared with neutral language and were more likely to use labels compared with participants in the neutral condition.,"['Participants ( N = 310', 'Sex Offender"" Versus ""Person']",['label condition or a neutral condition and completed an anonymous online survey about their willingness to volunteer with different groups'],[],"[{'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0699726', 'cui_str': 'Offenders'}, {'cui': 'C0027361', 'cui_str': 'Persons'}]","[{'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]",[],310.0,0.0359579,Participants in the labeling condition showed greater voluntary use of labels compared with neutral language and were more likely to use labels compared with participants in the neutral condition.,"[{'ForeName': 'Giulia', 'Initials': 'G', 'LastName': 'Lowe', 'Affiliation': 'The University of Auckland, New Zealand.'}, {'ForeName': 'Gwenda', 'Initials': 'G', 'LastName': 'Willis', 'Affiliation': 'The University of Auckland, New Zealand.'}]",Sexual abuse : a journal of research and treatment,['10.1177/1079063219841904'] 1114,31016503,"Growth Trajectories of Peer Norms, Self-efficacy and Condom Use Behavior Among Sexually Active Chinese Men Who Have Sex with Men: Latent Class Analysis and Growth Mixture Modeling.","Data from a randomized controlled trial in 2015 were used to estimate the growth trajectories of peer norms, self-efficacy, and condom use behavior, and to identify associated sociodemographic and behavioral factors among a sample of 804 Chinese men who have sex with men (MSM). Latent class analysis and growth mixture modeling were conducted using Mplus. Two growth trajectories were estimated for each outcome variable with good model fit. The growth trajectories of peer norms were related to age (β = - 0.066, p < 0.05). The growth trajectories of self-efficacy were related to age (β = 0.057, p < 0.01) and using a condom during first sexual encounter with another man (β = 0.777, p < 0.001). The growth trajectories of condom use behavior were related to income (β = 0.366, p < 0.01) and having casual male partners (β = - 1.016, p < 0.001). Predictors for the growth factors within each latent class were also estimated. For subsets of MSM who are older, richer, used a condom during their first sexual encounter with another man, and do not have a casual male partner, condom videos may not have sufficient efficacy and other interventions may be necessary.",2020,"The growth trajectories of condom use behavior were related to income (β = 0.366, p < 0.01) and having casual male partners (β = - 1.016, p < 0.001).","['Sexually Active Chinese Men', '804 Chinese men who have sex with men (MSM', 'Who Have Sex with Men']",[],"['growth trajectories of peer norms', 'growth trajectories of condom use behavior', 'growth trajectories of self-efficacy', 'Growth Trajectories of Peer Norms, Self-efficacy and Condom Use Behavior']","[{'cui': 'C0241028', 'cui_str': 'Sexually active (finding)'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}]",[],"[{'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0009653', 'cui_str': 'Condoms'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}]",804.0,0.0225849,"The growth trajectories of condom use behavior were related to income (β = 0.366, p < 0.01) and having casual male partners (β = - 1.016, p < 0.001).","[{'ForeName': 'Haochu', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Department of Epidemiology, School of Public Health, Shandong University, 44 West Wenhua Road, Jinan, 250012, Shandong, China. haochuli@yahoo.com.'}, {'ForeName': 'Joseph D', 'Initials': 'JD', 'LastName': 'Tucker', 'Affiliation': 'UNC Project-China, Institute for Global Health and Infectious Diseases, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Ma', 'Affiliation': 'Department of Epidemiology, School of Public Health, Shandong University, 44 West Wenhua Road, Jinan, 250012, Shandong, China.'}, {'ForeName': 'Eun Sook', 'Initials': 'ES', 'LastName': 'Kim', 'Affiliation': 'Department of Educational and Psychological Studies, University of South Florida, Tampa, FL, USA.'}, {'ForeName': 'Gifty', 'Initials': 'G', 'LastName': 'Marley', 'Affiliation': 'Department of Epidemiology and Health Statistics, School of Public Health, Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Dianmin', 'Initials': 'D', 'LastName': 'Kang', 'Affiliation': 'Shandong Provincial Center for Disease Control and Prevention, Jinan, China.'}, {'ForeName': 'Meizhen', 'Initials': 'M', 'LastName': 'Liao', 'Affiliation': 'Shandong Provincial Center for Disease Control and Prevention, Jinan, China.'}, {'ForeName': 'Weiming', 'Initials': 'W', 'LastName': 'Tang', 'Affiliation': 'UNC Project-China, Institute for Global Health and Infectious Diseases, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Baofa', 'Initials': 'B', 'LastName': 'Jiang', 'Affiliation': 'Department of Epidemiology, School of Public Health, Shandong University, 44 West Wenhua Road, Jinan, 250012, Shandong, China.'}]",AIDS and behavior,['10.1007/s10461-019-02515-7'] 1115,31948661,Insulin Resistance Modifies the Effects of Omega-3 Acid Ethyl Esters on Left Ventricular Remodeling After Acute Myocardial Infarction (from the OMEGA-REMODEL Randomized Clinical Trial).,"Insulin resistance early after acute myocardial infarction is associated with increased heart failure and mortality. OMEGA-REMODEL was a prospective double-blind 1:1 randomized control trial of patients with AMI. We reported that 6-month treatment with omega-3 fatty acid (O-3FA) 4 g/day attenuated cardiac remodeling accompanied by reduction in inflammation. We hypothesized that insulin resistance modifies the therapeutic effect of O-3FA on post-MI cardiac remodeling. The OMEGA-REMODEL study group was dichotomized according to cohort- and gender-specific median cutoff value of leptin-to-adiponectin ratio (LAR) at baseline (LAR-Hi vs LAR-Lo). Mixed model regression analyses were used to evaluate effect modification of O-3FA on reduction of left ventricular end-systolic volume index (LVESVI) by LAR status. Baseline LAR was evaluated on 325 patients (59 ± 11 years, 81% male). A total of 168 patients were categorized in LAR-Lo, and 157 in LAR-Hi. O-3FA treatment resulted in significant LVESVI reduction in patients with LAR-Lo but not with LAR-Hi (p = 0.0002 vs 0.66, respectively). Mixed model regression analysis showed significant modification of LAR on O-3FA's treatment effect in attenuating LVESVI (p = 0.021). In conclusion, this post-hoc efficacy analysis suggests that LAR status significantly modified O-3FA's treatment effect in attenuating cardiac remodeling. During the convalescent phase of acute infarct healing, patients with lower insulin resistance estimated by LAR appear to derive more therapeutic response from O-3FA toward improvement of LVESVI.",2020,"O-3FA treatment resulted in significant LVESVI reduction in patients with LAR-Lo but not with LAR-Hi (p = 0.0002 vs 0.66, respectively).","['patients with AMI', '325 patients (59 ± 11 years, 81% male', '168 patients were categorized in LAR-Lo, and 157 in LAR-Hi']","['omega-3 fatty acid (O-3FA', 'O-3FA', 'Omega-3 Acid Ethyl Esters']","['reduction of left ventricular end-systolic volume index (LVESVI', 'heart failure and mortality', 'LVESVI reduction', 'Left Ventricular Remodeling', 'leptin-to-adiponectin ratio (LAR']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4517714', 'cui_str': 'Three hundred and twenty-five'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C4319556', 'cui_str': 'One hundred and sixty-eight'}]","[{'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C1532673', 'cui_str': 'Omega-3 Acid Ethyl Esters (USP)'}]","[{'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0080308', 'cui_str': 'Ventricular End-Systolic Volume'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",325.0,0.0365851,"O-3FA treatment resulted in significant LVESVI reduction in patients with LAR-Lo but not with LAR-Hi (p = 0.0002 vs 0.66, respectively).","[{'ForeName': 'Kana', 'Initials': 'K', 'LastName': 'Fujikura', 'Affiliation': 'Advanced Cardiovascular Imaging Laboratory, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Bobak', 'Initials': 'B', 'LastName': 'Heydari', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, University of Calgary, Calgary, Canada.'}, {'ForeName': 'Yin', 'Initials': 'Y', 'LastName': 'Ge', 'Affiliation': ""Noninvasive Cardiovascular Imaging Section, Department of Radiology and Cardiovascular Division of the Department of Medicine, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Kyoichi', 'Initials': 'K', 'LastName': 'Kaneko', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Showa University Hospital, Tokyo, Japan.'}, {'ForeName': 'Shuaib', 'Initials': 'S', 'LastName': 'Abdullah', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, University of Texas Southwestern Medical Center, Dallas, Texas.'}, {'ForeName': 'William S', 'Initials': 'WS', 'LastName': 'Harris', 'Affiliation': 'Department of Internal Medicine, Sanford School of Medicine, University of South Dakota, Sioux Falls, South Dakota.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Jerosch-Herold', 'Affiliation': ""Noninvasive Cardiovascular Imaging Section, Department of Radiology and Cardiovascular Division of the Department of Medicine, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Raymond Y', 'Initials': 'RY', 'LastName': 'Kwong', 'Affiliation': ""Noninvasive Cardiovascular Imaging Section, Department of Radiology and Cardiovascular Division of the Department of Medicine, Brigham and Women's Hospital, Boston, Massachusetts; Cardiovascular Division, Department of Medicine, Brigham and Women's Hospital, Boston, Massachusetts. Electronic address: rykwong@bwh.harvard.org.""}]",The American journal of cardiology,['10.1016/j.amjcard.2019.11.032'] 1116,30955351,Does exposure to information about dementia change stigma? An experimental study.,"Objectives: Educational programs on dementia may backfire, as recipients could feel more negatively about people with dementia after exposure to the alarming symptoms (e.g., behavioral and psychological symptoms of dementia, or BPSD). This study aimed to investigate whether such exposures had any effect on stigma. Methods: 200 adults aged 18-83 years were randomly assigned to three groups. The first group read vignettes describing fictitious older adults with memory impairment . The second group read the same vignettes that were expanded to include descriptions of BPSD (i.e., memory impairment cum BPSD). After reading the vignettes, both groups answered questions about stigma, while the third group directly responded to this questionnaire without reading any vignette (i.e., not exposed to experimental manipulation). ANOVA was performed to analyze the effect of experimental manipulation, as well as that of age, education, whether having relatives with dementia, and belief about treatability of dementia. Results: At posttest, the level of stigma was moderate and was comparable across the three groups, suggesting that exposures to information about cognitive and behavioral symptoms did not change people's stigmatizing attitude. The absence of group effect in stigma did not vary by age, education, whether having a relative with dementia, or belief about prognosis. Only the main effects of age and education were significant, where younger and least educated participants reported higher stigma. Conclusion: There was no evidence that stigma would be affected by exposure to information about symptoms of dementia, including the more disturbed ones (i.e., BPSD).",2020,"There was no evidence that stigma would be affected by exposure to information about symptoms of dementia, including the more disturbed ones (i.e., BPSD).","['fictitious older adults with memory impairment', '200 adults aged 18-83\u2009years']",[],"['higher stigma', 'level of stigma']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0233794', 'cui_str': 'Memory Deficits'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]",[],"[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0277787', 'cui_str': 'Stigma (finding)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",200.0,0.0514736,"There was no evidence that stigma would be affected by exposure to information about symptoms of dementia, including the more disturbed ones (i.e., BPSD).","[{'ForeName': 'Fan', 'Initials': 'F', 'LastName': 'Zhang', 'Affiliation': 'Department of Health and Physical Education, The Education University of Hong Kong, Tai Po, Hong Kong.'}, {'ForeName': 'Sheung-Tak', 'Initials': 'ST', 'LastName': 'Cheng', 'Affiliation': 'Department of Health and Physical Education, The Education University of Hong Kong, Tai Po, Hong Kong.'}]",Aging & mental health,['10.1080/13607863.2019.1599817'] 1117,31009528,Six Month Abstinence Heterogeneity in the Best Quit Study.,"BACKGROUND Understanding the characteristics of smokers who are successful in quitting may help to increase smoking cessation rates. PURPOSE To examine heterogeneity in cessation outcome at 6 months following smoking cessation behavioral counseling with or without weight management counseling. METHODS 2,540 smokers were recruited from a large quitline provider and then randomized to receive proactive smoking cessation behavioral counseling without or with two versions of weight management counseling. A Classification and Regression Tree (CART) analysis was conducted to identify the individual pretreatment and treatment characteristics of groups of smokers with different quitting success (as measured by point prevalence of self-reported smoking of any amount at 6 months). RESULTS CART analysis identified 10 subgroups ranging from 25.5% to 70.2% abstinent. The splits in the CART tree involved: the total number of counseling and control calls received, whether a smoking cessation pharmacotherapy was used, and baseline measures of cigarettes per day, confidence in quitting, expectation that the study would help the participant quit smoking, the motivation to quit, exercise minutes per week, anxiety, and lack of interest or pleasure in doing things. Costs per quitter ranged from a low of $US270 to a high of $US630. Specific treatment recommendations are made for each group. CONCLUSIONS These results indicate the presence of a substantial variation in abstinence following treatment, and that the total extent of contact via counseling calls of any type and baseline characteristics, rather than assigned treatment, were most important to subgroup membership and abstinence. Tailored treatments to subgroups who are at high risk for smoking following a quit attempt could increase successful smoking cessation.",2019,Costs per quitter ranged from a low of $US270 to a high of $US630.,"['2,540 smokers were recruited from a large quitline provider']","['smoking cessation behavioral counseling with or without weight management counseling', 'proactive smoking cessation behavioral counseling without or with two versions of weight management counseling']",['successful smoking cessation'],"[{'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}]","[{'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C4546207', 'cui_str': 'Behavioral counseling (procedure)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}]","[{'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}]",2540.0,0.0261545,Costs per quitter ranged from a low of $US270 to a high of $US630.,"[{'ForeName': 'Harold S', 'Initials': 'HS', 'LastName': 'Javitz', 'Affiliation': 'Education Division, SRI International, Menlo Park, CA, USA.'}, {'ForeName': 'Terry M', 'Initials': 'TM', 'LastName': 'Bush', 'Affiliation': 'Optum Center for Wellbeing Research, Optum, Seattle, WA USA.'}, {'ForeName': 'Jennifer C', 'Initials': 'JC', 'LastName': 'Lovejoy', 'Affiliation': 'Optum Center for Wellbeing Research, Arivale, Inc and Institute for Systems Biology, Seattle, WA, USA.'}, {'ForeName': 'Alula J', 'Initials': 'AJ', 'LastName': 'Torres', 'Affiliation': 'Optum Center for Wellbeing Research, Optum, Seattle, WA USA.'}, {'ForeName': 'Tallie', 'Initials': 'T', 'LastName': 'Wetzel', 'Affiliation': 'Education Division, SRI International, Menlo Park, CA, USA.'}, {'ForeName': 'Ken P', 'Initials': 'KP', 'LastName': 'Wassum', 'Affiliation': 'Optum Center for Wellbeing Research, Optum, Seattle, WA USA.'}, {'ForeName': 'Marcia M', 'Initials': 'MM', 'LastName': 'Tan', 'Affiliation': 'Department of Preventive Medicine, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.'}, {'ForeName': 'Nabil', 'Initials': 'N', 'LastName': 'Alshurafa', 'Affiliation': 'Department of Preventive Medicine, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.'}, {'ForeName': 'Bonnie', 'Initials': 'B', 'LastName': 'Spring', 'Affiliation': 'Department of Preventive Medicine, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.'}]",Annals of behavioral medicine : a publication of the Society of Behavioral Medicine,['10.1093/abm/kaz014'] 1118,31713464,Shifting Maladaptive Fall Risk Appraisal in Older Adults through an in-Home Physio-fEedback and Exercise pRogram (PEER): A Pilot Study.,"OBJECTIVES 1) examine the preliminary effectiveness of the P hysio-fe E dback and E xercise p R ogram (PEER) for shifting maladaptive to adaptive fall risk appraisal and reducing fall risk, 2) determine the participants' feedback and acceptability of the program. METHODS Forty-one older adults were assigned to either PEER intervention or attention control group. The 8-week PEER intervention consists of a visual physio-feedback, cognitive reframing, and combined group and home-based exercise led by a trained peer coach. The attention control group read fall prevention brochures and continued their normal activities. BTrackS Balance Test (BBT), short version of Fall Efficacy Scale International (short FES-I) and CDC fall risk checklist were measured from pre- to post-intervention. The feedback and acceptability were conducted at the program conclusion. RESULTS About 11% of participants in the PEER group had positive shifting but none in the attention control group. Up to 32% of the participants in attention control had negative shifting compared to 5.3% in the PEER group. PEER group reported significant decreases in fall risk and high acceptability of the program. CONCLUSIONS PEER intervention facilitates a shift from maladaptive to adaptive fall risk appraisal and reduces fall risk. CLINICAL IMPLICATIONS Preventive interventions promoting alignment between perceive and physiological fall risk may contribute to reducing falls and increasing exercise adherence.",2020,Up to 32% of the participants in attention control had negative shifting compared to 5.3% in the PEER group.,"['Older Adults', 'Forty-one older adults']","['Exercise pRogram (PEER', 'PEER intervention consists of a visual physio-feedback, cognitive reframing, and combined group and home-based exercise led by a trained peer coach', 'P hysio-fe E dback and E xercise p R ogram (PEER', 'PEER intervention or attention control group']","['negative shifting', 'feedback and acceptability', 'fall risk and high acceptability', 'BTrackS Balance Test (BBT), short version of Fall Efficacy Scale International (short FES-I) and CDC fall risk checklist']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0557773', 'cui_str': 'Coach (physical object)'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C1268740', 'cui_str': 'Fall risk'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C0000921', 'cui_str': 'Falls'}, {'cui': 'C0222045'}, {'cui': 'C0674267', 'cui_str': 'greigite'}, {'cui': 'C0007670', 'cui_str': 'CDC'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}]",41.0,0.0181214,Up to 32% of the participants in attention control had negative shifting compared to 5.3% in the PEER group.,"[{'ForeName': 'Ladda', 'Initials': 'L', 'LastName': 'Thiamwong', 'Affiliation': 'College of Nursing, University of Central Florida , Orlando, Florida, USA.'}, {'ForeName': 'Helen J', 'Initials': 'HJ', 'LastName': 'Huang', 'Affiliation': 'Disability, Aging, and Technology Cluster, University of Central Florida , Orlando, Florida, USA.'}, {'ForeName': 'Boon Peng', 'Initials': 'BP', 'LastName': 'Ng', 'Affiliation': 'College of Nursing, University of Central Florida , Orlando, Florida, USA.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Yan', 'Affiliation': 'Department of Statistics and Data Science, College of Science, University of Central Florida , Orlando, Florida, USA.'}, {'ForeName': 'Mary Lou', 'Initials': 'ML', 'LastName': 'Sole', 'Affiliation': 'College of Nursing, University of Central Florida , Orlando, Florida, USA.'}, {'ForeName': 'Jeffrey R', 'Initials': 'JR', 'LastName': 'Stout', 'Affiliation': 'School of Kinesiology and Physical Therapy, College of Health Professions and Sciences, University of Central Florida , Orlando, Florida, USA.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Talbert', 'Affiliation': 'College of Nursing, University of Central Florida , Orlando, Florida, USA.'}]",Clinical gerontologist,['10.1080/07317115.2019.1692120'] 1119,30951609,Mental health stigma in depressed Latinos over the course of therapy: Results from a randomized controlled trial.,"OBJECTIVE The current study examined the course, correlates, and predictors of mental health stigma among depressed, Spanish-speaking Latinos that were receiving treatment. This population faces significant disparities in mental health treatment and carries high levels of mental health stigma. METHOD The study utilized data generated from a randomized clinical trial (N = 46) that evaluated the efficacy of Behavioral Activation and Supportive Counseling for depression among Latinos. RESULTS Mental health stigma decreased over time; these decreases were more pronounced among individuals who were randomized to Supportive Counseling. Mental health stigma was positively associated with depressive symptoms and therapeutic alliance over time. Mental health stigma was not related to treatment attrition. CONCLUSIONS These preliminary findings indicate that mental health stigma continues to be relevant among individuals who are actively participating in treatment. Receiving mental health treatment may be sufficient to dispel some of the stigmatizing views endorsed by underserved clinical populations.",2019,"Mental health stigma was not related to treatment attrition. ",['individuals who are actively participating in treatment'],['Behavioral Activation and Supportive Counseling'],"['Mental health stigma', 'mental health stigma']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C3697360', 'cui_str': 'Supportive counseling'}]","[{'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0277787', 'cui_str': 'Stigma (finding)'}]",,0.0479004,"Mental health stigma was not related to treatment attrition. ","[{'ForeName': 'Anahi', 'Initials': 'A', 'LastName': 'Collado', 'Affiliation': 'Department of Psychology, Cofrin Logan Center for Addiction Research and Treatment, University of Kansas, Lawrence, Kansas.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Zvolensky', 'Affiliation': 'Department of Psychology, University of Houston, Houston, Texas.'}, {'ForeName': 'Carl', 'Initials': 'C', 'LastName': 'Lejuez', 'Affiliation': 'Department of Psychology, University of Kansas, Lawrence, Kansas.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'MacPherson', 'Affiliation': 'School of Medicine, Greenebaum Comprehensive Cancer Center, University of Maryland, Baltimore, Maryland.'}]",Journal of clinical psychology,['10.1002/jclp.22777'] 1120,31017076,Problem-solving intervention to prevent depression in non-professional caregivers: a randomized controlled trial with 8 years of follow-up.,"BACKGROUND Studies of psychological interventions for the prevention of depression have found significant effects in the short-term, but the long-term efficacy has yet to be determined. This study evaluated the 8-year effect of a randomized controlled trial for indicated prevention of depression in female caregivers. METHODS A total of 173 non-professional female caregivers with subclinical depressive symptoms not meeting criteria for a major depressive episode (MDE) were randomized to either a brief problem-solving intervention (n = 89) or usual-care control group (n = 84). Blinded evaluators conducted an assessment at the 8-year follow-up. The primary outcome was Depression Status, defined by diagnoses of MDE since the 1-year follow-up using the Structured Clinical Interview for the Disorders of the DSM-5. The secondary outcome was current Depressive Symptom Severity. Regression analyses were conducted to evaluate the effect of the intervention on the outcomes. RESULTS There were no significant differences in the Depression Status between the problem-solving (30.3%) and control groups (26.2%) (adjusted OR 1.25, 95% CI -0.58 to 2.69). Depressive Symptom Severity, however, was significantly lower in the problem-solving group compared to the control group at this follow-up, amounting to a small effect size of Cohen's d = 0.39 (adjusted B = -3.32, p = 0.018). CONCLUSIONS This is the first study to assess such a long-term follow-up of intervention of indicated prevention of depression. Results seem to indicate that the protective effect of the intervention became smaller over time during follow-up. Future research should replicate these results.",2020,"There were no significant differences in the Depression Status between the problem-solving (30.3%) and control groups (26.2%) (adjusted OR 1.25, 95% CI -0.58 to 2.69).","['173 non-professional female caregivers with subclinical depressive symptoms not meeting criteria for a major depressive episode (MDE', 'non-professional caregivers', 'female caregivers']","['brief problem-solving intervention (n = 89) or usual-care control group', 'Problem-solving intervention']","['Depressive Symptom Severity', 'Depression Status, defined by diagnoses of MDE since the 1-year follow-up using the Structured Clinical Interview for the Disorders of the DSM-5', 'Depression Status', 'current Depressive Symptom Severity']","[{'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0205211', 'cui_str': 'Subclinical (qualifier value)'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0349217', 'cui_str': 'Depressive episode'}]","[{'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C3669643', 'cui_str': 'Problem solving (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0199182', 'cui_str': 'Taking health history'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}]",173.0,0.0760938,"There were no significant differences in the Depression Status between the problem-solving (30.3%) and control groups (26.2%) (adjusted OR 1.25, 95% CI -0.58 to 2.69).","[{'ForeName': 'Lara', 'Initials': 'L', 'LastName': 'López', 'Affiliation': 'Department of Clinical Psychology and Psychobiology, University of Santiago de Compostela, Santiago de Compostela, Spain.'}, {'ForeName': 'Filip', 'Initials': 'F', 'LastName': 'Smit', 'Affiliation': 'Trimbos Institute, Netherlands Institute of Mental Health and Addiction, Utrecht, The Netherlands.'}, {'ForeName': 'Pim', 'Initials': 'P', 'LastName': 'Cuijpers', 'Affiliation': 'Department of Clinical, Neuro and Developmental Psychology, Amsterdam Public Health research institute, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Otero', 'Affiliation': 'Department of Psychology, University of A Coruña, A Coruña, Spain.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Blanco', 'Affiliation': 'Department of Evolutive and Educational Psychology, University of Santiago de Compostela, Santiago de Compostela, Spain.'}, {'ForeName': 'Ángela', 'Initials': 'Á', 'LastName': 'Torres', 'Affiliation': 'Department of Psychiatry, Radiology, Public Health, Nursing and Medicine, University of Santiago de Compostela, Santiago de Compostela, Spain.'}, {'ForeName': 'Fernando L', 'Initials': 'FL', 'LastName': 'Vázquez', 'Affiliation': 'Department of Clinical Psychology and Psychobiology, University of Santiago de Compostela, Santiago de Compostela, Spain.'}]",Psychological medicine,['10.1017/S0033291719000916'] 1121,31682972,Fatigue and sleepiness responses to experimental inflammation and exploratory analysis of the effect of baseline inflammation in healthy humans.,"Inflammation is believed to be a central mechanism in the pathophysiology of fatigue. While it is likely that dynamic of the fatigue response after an immune challenge relates to the corresponding cytokine release, this lacks evidence. Although both fatigue and sleepiness are strong signals to rest, they constitute distinct symptoms which are not necessarily associated, and sleepiness in relation to inflammation has been rarely investigated. Here, we have assessed the effect of an experimental immune challenge (administration of lipopolysaccharide, LPS) on the development of both fatigue and sleepiness, and the associations between increases in cytokine concentrations, fatigue and sleepiness, in healthy volunteers. In addition, because chronic-low grade inflammation may represent a risk factor for fatigue, we tested whether higher baseline levels of inflammation result in a more pronounced development of cytokine-induced fatigue and sleepiness. Data from four experimental studies was combined, giving a total of 120 subjects (LPS N = 79, 18 (23%) women; Placebo N = 69, 12 (17%) women). Administration of LPS resulted in a stronger increase in fatigue and sleepiness compared to the placebo condition, and the development of both fatigue and sleepiness closely paralleled the cytokine responses. Individuals with stronger increases in cytokine concentrations after LPS administration also suffered more from fatigue and sleepiness (N = 75), independent of gender. However, there was no support for the hypothesis that higher baseline inflammatory markers moderated the responses in fatigue or sleepiness after an inflammatory challenge. The results demonstrate a tight connection between the acute inflammatory response and development of both fatigue and sleepiness, and motivates further investigation of the involvement of inflammation in the pathophysiology of central fatigue.",2020,"Individuals with stronger increases in cytokine concentrations after LPS administration also suffered more from fatigue and sleepiness (N=75), independent of gender.","['120 subjects (LPS N=79, 18 (23%) women', 'healthy volunteers', 'healthy humans']","['Placebo', 'LPS', 'lipopolysaccharide, LPS']","['fatigue or sleepiness', 'cytokine concentrations', 'fatigue and sleepiness', 'cytokine concentrations, fatigue and sleepiness', 'Fatigue and sleepiness responses']","[{'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0023810', 'cui_str': 'Lipoglycans'}]","[{'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C2830004', 'cui_str': 'Somnolence'}, {'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",120.0,0.0798114,"Individuals with stronger increases in cytokine concentrations after LPS administration also suffered more from fatigue and sleepiness (N=75), independent of gender.","[{'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Lasselin', 'Affiliation': 'Institute of Medical Psychology and Behavioral Immunobiology, University Hospital Essen, University of Duisburg-Essen, Hufelandstr. 55, 45 122 Essen, Germany; Department of Clinical Neuroscience, Karolinska Institutet, Nobels väg 9, 171 65 Solna, Stockholm, Sweden; Stress Research Institute, Stockholm University, Frescati Hagväg 16A, 106 91 Stockholm, Sweden. Electronic address: julie.lasselin@su.se.'}, {'ForeName': 'Bianka', 'Initials': 'B', 'LastName': 'Karshikoff', 'Affiliation': 'Department of Clinical Neuroscience, Karolinska Institutet, Nobels väg 9, 171 65 Solna, Stockholm, Sweden; Osher Center for Integrative Medicine, Karolinska Institutet, Nobels väg 9, 171 65 Solna, Stockholm, Sweden.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Axelsson', 'Affiliation': 'Department of Clinical Neuroscience, Karolinska Institutet, Nobels väg 9, 171 65 Solna, Stockholm, Sweden; Stress Research Institute, Stockholm University, Frescati Hagväg 16A, 106 91 Stockholm, Sweden.'}, {'ForeName': 'Torbjörn', 'Initials': 'T', 'LastName': 'Åkerstedt', 'Affiliation': 'Department of Clinical Neuroscience, Karolinska Institutet, Nobels väg 9, 171 65 Solna, Stockholm, Sweden; Stress Research Institute, Stockholm University, Frescati Hagväg 16A, 106 91 Stockholm, Sweden.'}, {'ForeName': 'Sven', 'Initials': 'S', 'LastName': 'Benson', 'Affiliation': 'Institute of Medical Psychology and Behavioral Immunobiology, University Hospital Essen, University of Duisburg-Essen, Hufelandstr. 55, 45 122 Essen, Germany.'}, {'ForeName': 'Harald', 'Initials': 'H', 'LastName': 'Engler', 'Affiliation': 'Institute of Medical Psychology and Behavioral Immunobiology, University Hospital Essen, University of Duisburg-Essen, Hufelandstr. 55, 45 122 Essen, Germany.'}, {'ForeName': 'Manfred', 'Initials': 'M', 'LastName': 'Schedlowski', 'Affiliation': 'Institute of Medical Psychology and Behavioral Immunobiology, University Hospital Essen, University of Duisburg-Essen, Hufelandstr. 55, 45 122 Essen, Germany.'}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Jones', 'Affiliation': 'Department of Psychology, Macquarie University, North Ryde, NSW, Australia.'}, {'ForeName': 'Mats', 'Initials': 'M', 'LastName': 'Lekander', 'Affiliation': 'Department of Clinical Neuroscience, Karolinska Institutet, Nobels väg 9, 171 65 Solna, Stockholm, Sweden; Stress Research Institute, Stockholm University, Frescati Hagväg 16A, 106 91 Stockholm, Sweden; Osher Center for Integrative Medicine, Karolinska Institutet, Nobels väg 9, 171 65 Solna, Stockholm, Sweden.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Andreasson', 'Affiliation': 'Stress Research Institute, Stockholm University, Frescati Hagväg 16A, 106 91 Stockholm, Sweden; Department of Psychology, Macquarie University, North Ryde, NSW, Australia.'}]","Brain, behavior, and immunity",['10.1016/j.bbi.2019.10.020'] 1122,30958026,A comparison of signal- and event-contingent ambulatory assessment of interpersonal behavior and affect in social situations.,"Ambulatory assessment (e.g., ecological momentary assessment) is now widely used in psychological research, yet key design decisions remain largely informed by methodological lore as opposed to systematic inquiry. The present study experimentally tested whether signal- (e.g., random prompt) and event- (e.g., complete a survey every time a target event occurs) contingent recording procedures of interpersonal behavior and affect in social situations yield equivalent quality and quantity of data. Participants (N = 286) completed baseline questionnaires, underwent cluster randomization to either a signal- or event-contingent condition, and then completed 1 week of ambulatory assessment, during which they answered questions about their social behavior and affect tied to their social interactions. Conditions were compared on response frequency, means and variances of interpersonal behavior and affect, correlations between interpersonal behavior and affect within-subject, and associations between momentary behavior and affect and baseline variables (e.g., Big Five traits). Results indicated that signal- and event-contingent recording techniques provided equivalent data quality, suggesting that researchers can use the 2 methodologies interchangeably to draw conclusions about means, variances, and associations when examining social interactions. However, results also showed that event-contingent recording returned, on average, a higher number of reported social interactions per individual, and this was true for most time periods of the day. Thus, event-contingent recording may hold advantages for studying frequency and timing of social interactions. (PsycINFO Database Record (c) 2019 APA, all rights reserved).",2019,"Conditions were compared on response frequency, means and variances of interpersonal behavior and affect, correlations between interpersonal behavior and affect within-subject, and associations between momentary behavior and affect and baseline variables (e.g., Big Five traits).",[],[],"['social situations', 'response frequency, means and variances of interpersonal behavior']",[],[],"[{'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}]",2019.0,0.0139156,"Conditions were compared on response frequency, means and variances of interpersonal behavior and affect, correlations between interpersonal behavior and affect within-subject, and associations between momentary behavior and affect and baseline variables (e.g., Big Five traits).","[{'ForeName': 'Philip H', 'Initials': 'PH', 'LastName': 'Himmelstein', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'William C', 'Initials': 'WC', 'LastName': 'Woods', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Aidan G C', 'Initials': 'AGC', 'LastName': 'Wright', 'Affiliation': 'Department of Psychology.'}]",Psychological assessment,['10.1037/pas0000718'] 1123,30741567,"Crocus sativus L. Versus Methylphenidate in Treatment of Children with Attention-Deficit/Hyperactivity Disorder: A Randomized, Double-Blind Pilot Study.","OBJECTIVE Attention-deficit/hyperactivity disorder (ADHD) is one of the most common neuropsychiatric disorders of childhood and adolescence. About 30% of patients do not respond to stimulants or cannot tolerate their side effects. Thus, alternative medication, like herbal medicine, should be considered. The aim of this trial is to compare the safety and efficacy of Crocus sativus (saffron) versus methylphenidate in improving symptoms of children with ADHD. METHODS In a 6-week randomized double-blind study, 54 patients (children 6-17 years old) with a Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) diagnosis of ADHD were randomly assigned to receive either 20-30 mg/d (20 mg/d for <30 kg and 30 mg/d for >30 kg) methylphenidate (MPH) or 20-30 mg/d saffron capsules depending on weight (20 mg/d for <30 kg and 30 mg/d for >30 kg). Symptoms were assessed using the Teacher and Parent Attention-Deficit/Hyperactivity Disorder Rating Scale-IV (ADHD-RS-IV) at baseline and weeks 3 and 6. RESULTS Fifty patients completed the trial. General linear model repeated measures showed no significant difference between the two groups on Parent and Teacher Rating Scale scores (F = 0.749, df = 1.317, p = 0.425, and F = 0.249, df = 1.410, p = 0.701, respectively). Changes in Teacher and Parent ADHD Rating Scale scores from baseline to the study end were not significantly different between the saffron group and the MPH group (p = 0.731 and p = 0.883, respectively). The frequency of adverse effects was similar between saffron and MPH groups. CONCLUSION Short-term therapy with saffron capsule showed the same efficacy compared with methylphenidate. Nevertheless, larger controlled studies with longer treatment periods are necessary for future studies.",2019,"Changes in Teacher and Parent ADHD Rating Scale scores from baseline to the study end were not significantly different between the saffron group and the MPH group (p = 0.731 and p = 0.883, respectively).","['54 patients (children 6-17 years old) with a Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) diagnosis of ADHD', 'Children with Attention-Deficit/Hyperactivity Disorder', 'Fifty patients completed the trial', 'children with ADHD']","['methylphenidate (MPH) or 20-30\u2009mg', 'methylphenidate', 'Crocus sativus (saffron', 'Methylphenidate']","['safety and efficacy', 'Teacher and Parent Attention-Deficit/Hyperactivity Disorder Rating Scale-IV (ADHD-RS-IV', 'frequency of adverse effects', 'Parent and Teacher Rating Scale scores', 'Changes in Teacher and Parent ADHD Rating Scale scores']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C1136324', 'cui_str': 'Diagnostic and Statistical Manual of Mental Disorders'}, {'cui': 'C0205439', 'cui_str': 'Fifth (qualifier value)'}, {'cui': 'C0441792', 'cui_str': 'Editions (qualifier value)'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]","[{'cui': 'C0025810', 'cui_str': 'Methylphenidate'}, {'cui': 'C0946614', 'cui_str': 'Crocus sativus'}, {'cui': 'C2348128', 'cui_str': 'Saffron'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0221457', 'cui_str': 'Teacher (occupation)'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C0222045'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}]",54.0,0.246779,"Changes in Teacher and Parent ADHD Rating Scale scores from baseline to the study end were not significantly different between the saffron group and the MPH group (p = 0.731 and p = 0.883, respectively).","[{'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Baziar', 'Affiliation': '1 Psychiatric Research Center, Roozbeh Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Aqamolaei', 'Affiliation': '1 Psychiatric Research Center, Roozbeh Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Ebrahim', 'Initials': 'E', 'LastName': 'Khadem', 'Affiliation': '2 Department of Persian Medicine, Faculty of Persian Medicine, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Seyyed Hosein', 'Initials': 'SH', 'LastName': 'Mortazavi', 'Affiliation': '1 Psychiatric Research Center, Roozbeh Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Sina', 'Initials': 'S', 'LastName': 'Naderi', 'Affiliation': '1 Psychiatric Research Center, Roozbeh Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Erfan', 'Initials': 'E', 'LastName': 'Sahebolzamani', 'Affiliation': '1 Psychiatric Research Center, Roozbeh Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Amirhosein', 'Initials': 'A', 'LastName': 'Mortezaei', 'Affiliation': '1 Psychiatric Research Center, Roozbeh Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Shakiba', 'Initials': 'S', 'LastName': 'Jalilevand', 'Affiliation': '1 Psychiatric Research Center, Roozbeh Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohammad-Reza', 'Initials': 'MR', 'LastName': 'Mohammadi', 'Affiliation': '1 Psychiatric Research Center, Roozbeh Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mahsa', 'Initials': 'M', 'LastName': 'Shahmirzadi', 'Affiliation': '1 Psychiatric Research Center, Roozbeh Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Shahin', 'Initials': 'S', 'LastName': 'Akhondzadeh', 'Affiliation': '1 Psychiatric Research Center, Roozbeh Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}]",Journal of child and adolescent psychopharmacology,['10.1089/cap.2018.0146'] 1124,30903972,"Is improved fitness following a 12-week exercise program associated with decreased symptom severity, better wellbeing, and fewer sleep complaints in patients with major depressive disorders? A secondary analysis of a randomized controlled trial.","Major depressive disorder (MDD) is one of the most burdensome disorders worldwide. While exercise training in patients with MDD contributes to clinically relevant improvements in cardiorespiratory fitness, whether and to what degree changes in cardiorespiratory fitness impact depressive symptom severity has not yet been addressed systematically in prior research. The purpose of our study was threefold. Firstly, to examine whether baseline levels and improvements in objectively assessed VO 2 max and subjectively perceived fitness predicted endpoint levels and change in depressive symptoms, wellbeing and sleep. Secondly, to determine whether exercise modality (sprint interval training [SIT]) versus continuous aerobic exercise training [CAT]) predicted depressive symptoms, wellbeing and sleep. Thirdly, whether the affective responses during and following exercise predicted depressive symptoms, wellbeing and sleep. All measurements were taken in a sample of inpatients diagnosed with MDD. The sample consisted of 53 participants (41 women and 12 men, M age  = 36.3 years, SD = 11.3) with unipolar depression who were randomly assigned to SIT and CAT. Data were assessed at baseline and after four weeks of exercise training (including three weekly 35 min sessions). Multiple linear regression analyses showed that improvements in VO 2 max were associated with fewer depressive symptoms, better mental wellbeing, and better sleep after completion of the intervention. Additionally, improvements in perceived fitness were associated with fewer dysfunctional sleep-related cognitions and higher mental toughness post-intervention. Improvements in VO2max and perceived fitness were also associated with favorable changes in depressive symptoms, mental wellbeing, and sleep. More research is needed to find out which fitness tests are most time- and cost-efficient in a clinical setting and most acceptable for psychiatric patients.",2019,"Improvements in VO2max and perceived fitness were also associated with favorable changes in depressive symptoms, mental wellbeing, and sleep.","['inpatients diagnosed with MDD', '53 participants (41 women and 12 men, M age \u202f=\u202f36.3 years, SD\u202f=\u202f11.3) with unipolar depression', 'Major depressive disorder (MDD', 'patients with MDD', 'patients with major depressive disorders', 'psychiatric patients']","['exercise training', 'exercise modality (sprint interval training [SIT]) versus continuous aerobic exercise training [CAT', 'SIT and CAT']","['depressive symptoms, wellbeing and sleep', 'sleep complaints', 'depressive symptoms, mental wellbeing, and sleep', 'depressive symptoms, better mental wellbeing, and better sleep', 'dysfunctional sleep-related cognitions']","[{'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0041696', 'cui_str': 'Unipolar Depression'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205487', 'cui_str': 'Psychiatric (qualifier value)'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C4279979', 'cui_str': 'Sprint Interval Training'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0001701', 'cui_str': 'Exercise, Aerobic'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0524517', 'cui_str': 'Felis'}, {'cui': 'C2584297', 'cui_str': 'Seated Position'}]","[{'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0277786', 'cui_str': 'Presenting complaint'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}]",53.0,0.0667552,"Improvements in VO2max and perceived fitness were also associated with favorable changes in depressive symptoms, mental wellbeing, and sleep.","[{'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Gerber', 'Affiliation': 'Department of Sport, Exercise and Health, University of Basel, Basel, Switzerland. Electronic address: Markus.gerber@unibas.ch.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Minghetti', 'Affiliation': 'Department of Sport, Exercise and Health, University of Basel, Basel, Switzerland. Electronic address: alice.minghetti@unibas.ch.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Beck', 'Affiliation': 'Clinic Sonnenhalde, Riehen, Switzerland. Electronic address: Johannes.beck@sonnenhalde.ch.'}, {'ForeName': 'Lukas', 'Initials': 'L', 'LastName': 'Zahner', 'Affiliation': 'Department of Sport, Exercise and Health, University of Basel, Basel, Switzerland. Electronic address: Lukas.zahner@unibas.ch.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Donath', 'Affiliation': 'Institute of Exercise Training and Sport Informatics, German Sport University Cologne, Cologne, Germany. Electronic address: lars.donath@dshs-koeln.de.'}]",Journal of psychiatric research,['10.1016/j.jpsychires.2019.03.011'] 1125,30943878,A randomized 500-subject open-label phase 3 clinical trial of minimally invasive surgery plus alteplase in intracerebral hemorrhage evacuation (MISTIE III).,"RATIONALE AND HYPOTHESIS Surgical removal of spontaneous intracerebral hemorrhage may reduce secondary destruction of brain tissue. However, large surgical trials of craniotomy have not demonstrated definitive improvement in clinical outcomes. Minimally invasive surgery may limit surgical tissue injury, and recent evidence supports testing these approaches in large clinical trials. METHODS AND DESIGN MISTIE III is an investigator-initiated multicenter, randomized, open-label phase 3 study investigating whether minimally invasive clot evacuation with thrombolysis improves functional outcomes at 365 days compared to conservative management. Patients with supratentorial intracerebral hemorrhage clot volume ≥ 30 mL, confirmed by imaging within 24 h ofknown symptom onset,and intact brainstem reflexes were screened with a stability computed tomography scan at least 6 h after diagnostic scan. Patients who met clinical and imaging criteria (no ongoing coagulopathy; no suspicion of aneurysm, arteriovenous malformation, or any other vascular anomaly; and stable hematoma size on consecutive scans) were randomized to either minimally invasive surgery plus thrombolysis or medical therapy. The sample size of 500 was based on findings of a phase 2 study. STUDY OUTCOMES The primary outcome measure is dichotomized modified Rankin Scale 0-3 vs. 4-6 at 365 days adjusting for severity variables. Clinical secondary outcomes include dichotomized extended Glasgow Outcome Scale and all-cause mortality at 365 days; rate and extent of parenchymal blood clot removal; patient disposition at 365 days; efficacy at 180 days; type and intensity of ICU management; and quality of life measures. Safety was assessed at 30 days and throughout the study.",2019,"Patients with supratentorial intracerebral hemorrhage clot volume ≥ 30 mL, confirmed by imaging within 24 h ofknown symptom onset,and intact brainstem reflexes were screened with a stability computed tomography scan at least 6 h after diagnostic scan.","['Patients with supratentorial intracerebral hemorrhage clot volume ≥\u200930 mL, confirmed by imaging within 24 h ofknown symptom onset,and intact brainstem reflexes', 'intracerebral hemorrhage evacuation (MISTIE III', 'Patients who met clinical and imaging criteria (no ongoing coagulopathy; no suspicion of aneurysm, arteriovenous malformation, or any other vascular anomaly; and stable hematoma size on consecutive scans']","['minimally invasive surgery plus alteplase', 'minimally invasive surgery plus thrombolysis or medical therapy', 'minimally invasive clot evacuation with thrombolysis']","['functional outcomes', 'dichotomized modified Rankin Scale 0-3 vs. 4-6 at 365 days adjusting for severity variables', 'Safety', 'dichotomized extended Glasgow Outcome Scale and all-cause mortality at 365 days; rate and extent of parenchymal blood clot removal; patient disposition at 365 days; efficacy at 180 days; type and intensity of ICU management; and quality of life measures']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441938', 'cui_str': 'Supratentorial (qualifier value)'}, {'cui': 'C2937358', 'cui_str': 'Intracerebral Hemorrhage'}, {'cui': 'C0302148', 'cui_str': 'Blood coagulum'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by (contextual qualifier) (qualifier value)'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0205266', 'cui_str': 'Intact (qualifier value)'}, {'cui': 'C0006121', 'cui_str': 'Truncus Cerebri'}, {'cui': 'C0034929', 'cui_str': 'Reflex'}, {'cui': 'C1282573', 'cui_str': 'Evacuation procedure'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0005779', 'cui_str': 'Blood Coagulation Disorders'}, {'cui': 'C0242114', 'cui_str': 'Suspicion'}, {'cui': 'C0002940', 'cui_str': 'Aneurysm'}, {'cui': 'C0003857', 'cui_str': 'Arteriovenous Malformations'}, {'cui': 'C0158570', 'cui_str': 'Vascular Malformations'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0018944', 'cui_str': 'Hematoma'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0441633'}]","[{'cui': 'C0282624', 'cui_str': 'Minimal Surgical Procedures'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0032143', 'cui_str': 'alteplase'}, {'cui': 'C0520997', 'cui_str': 'Thrombolysis, function (observable entity)'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy (procedure)'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C0302148', 'cui_str': 'Blood coagulum'}, {'cui': 'C1282573', 'cui_str': 'Evacuation procedure'}]","[{'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0231449', 'cui_str': 'Extended (qualifier value)'}, {'cui': 'C0701887', 'cui_str': 'Glasgow Outcome Scale'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0439792', 'cui_str': 'Extents (qualifier value)'}, {'cui': 'C0302148', 'cui_str': 'Blood coagulum'}, {'cui': 'C0015252', 'cui_str': 'Removal - action (qualifier value)'}, {'cui': 'C0184758', 'cui_str': 'Patient disposition'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0034380'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}]",,0.190994,"Patients with supratentorial intracerebral hemorrhage clot volume ≥ 30 mL, confirmed by imaging within 24 h ofknown symptom onset,and intact brainstem reflexes were screened with a stability computed tomography scan at least 6 h after diagnostic scan.","[{'ForeName': 'Wendy C', 'Initials': 'WC', 'LastName': 'Ziai', 'Affiliation': '1 Division of Neurosciences Critical Care, Department of Neurology, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Nichol', 'Initials': 'N', 'LastName': 'McBee', 'Affiliation': '2 Division of Brain Injury Outcomes, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Lane', 'Affiliation': '2 Division of Brain Injury Outcomes, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Kennedy R', 'Initials': 'KR', 'LastName': 'Lees', 'Affiliation': '3 School of Medicine, Dentistry and Nursing, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Jesse', 'Initials': 'J', 'LastName': 'Dawson', 'Affiliation': '4 Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Vespa', 'Affiliation': '5 Department of Neurosurgery, University of California, Los Angeles, CA, USA.'}, {'ForeName': 'Richard E', 'Initials': 'RE', 'LastName': 'Thompson', 'Affiliation': '6 Department of Biostatistics, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'A David', 'Initials': 'AD', 'LastName': 'Mendelow', 'Affiliation': '7 Department of Neurosurgery, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Carlos S', 'Initials': 'CS', 'LastName': 'Kase', 'Affiliation': '8 Department of Neurology, Emory University, Atlanta, GA, USA.'}, {'ForeName': 'J Ricardo', 'Initials': 'JR', 'LastName': 'Carhuapoma', 'Affiliation': '1 Division of Neurosciences Critical Care, Department of Neurology, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Carol B', 'Initials': 'CB', 'LastName': 'Thompson', 'Affiliation': '9 Biostatistics Center, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Steven W', 'Initials': 'SW', 'LastName': 'Mayo', 'Affiliation': '10 Emissary International LLC, Austin, TX, USA.'}, {'ForeName': 'Pat', 'Initials': 'P', 'LastName': 'Reilly', 'Affiliation': '11 Genentech Inc., San Francisco, CA, USA (retired).'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Janis', 'Affiliation': '13 National Institute of Neurological Disorders and Stroke, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Craig S', 'Initials': 'CS', 'LastName': 'Anderson', 'Affiliation': '14 The George Institute for Global Health China at Peking University Health Science Center, Beijing, China.'}, {'ForeName': 'Mark R', 'Initials': 'MR', 'LastName': 'Harrigan', 'Affiliation': '16 Department of Neurosurgery, University of Alabama, Birmingham, AL, USA.'}, {'ForeName': 'Paul J', 'Initials': 'PJ', 'LastName': 'Camarata', 'Affiliation': '17 Department of Neurosurgery, University of Kansas, Kansas City, KS, USA.'}, {'ForeName': 'Jean-Louis', 'Initials': 'JL', 'LastName': 'Caron', 'Affiliation': '18 Department of Neurosurgery, University of Texas, San Antonio, TX, USA.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Zuccarello', 'Affiliation': '19 Department of Neurosurgery, University of Cincinnati, Cincinnati, OH, USA.'}, {'ForeName': 'Issam A', 'Initials': 'IA', 'LastName': 'Awad', 'Affiliation': '20 Section of Neurosurgery, Neurovascular Surgery Program, University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Daniel F', 'Initials': 'DF', 'LastName': 'Hanley', 'Affiliation': '2 Division of Brain Injury Outcomes, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",International journal of stroke : official journal of the International Stroke Society,['10.1177/1747493019839280'] 1126,30943777,Standard and accelerated corneal cross-linking long-term results: A randomized clinical trial.,"PURPOSE To compare long-term results between accelerated and standard corneal cross-linking protocols in the treatment of progressive keratoconus and compare their effectiveness between central (cone in the central 3 mm) and peripheral (cone beyond 3 mm) cases. METHODS In this randomized clinical trial, we compared 31 eyes treated with accelerated corneal cross-linking (18 mW/cm 2 , 5 min) and 31 eyes treated with standard corneal cross-linking (3 mW/cm 2 , 30 min), 16 central and 11 peripheral keratoconus in each group. In this report, 4-year changes in vision, refraction, topography, corneal biomechanics, and corneal cell count were evaluated. RESULTS Uncorrected distance visual acuity improvement was better with standard corneal cross-linking (0.19 ± 0.30 logMAR) than accelerated corneal cross-linking (0.08 ± 0.35 logMAR), but the intergroup difference was not statistically significant (p = 0.283). Cylinder and spherical equivalent significantly increased similarly in both groups. Among topographic indices, anterior Kmax-3 mm showed more reduction in standard corneal cross-linking than accelerated corneal cross-linking (1.35 ± 1.39 vs 0.36 ± 1.10 D, p = 0.011). Anterior Kmax-8 mm reduced by 1.50 ± 1.82 and 0.37 ± 1.58 D in the standard corneal cross-linking and accelerated corneal cross-linking groups, respectively (p = 0.029). Compared to 18-month results, none of the indices at 4 years showed any significant intergroup difference (all p > 0.05). In cases with peripheral keratoconus, changes in anterior Kmax-3 mm (+0.03 ± 0.66 vs -1.17 ± 1.15 D, p = 0.012) and anterior Kmax-8 mm (+0.43 ± 1.09 vs -1.57 ± 1.40 D, p = 0.003) were greater with standard corneal cross-linking. In central cases, no significant intergroup difference was observed. CONCLUSION At 4 years after the procedure, standard corneal cross-linking offered better anterior corneal flattening in the center and periphery. These differences concerned cases of peripheral keratoconus, and the two protocols were similarly effective in central cases. Beyond the 18th month, the two protocols appeared to be similarly effective.",2020,"At 4 years after the procedure, standard corneal cross-linking offered better anterior corneal flattening in the center and periphery.","['31 eyes treated with accelerated corneal cross-linking (18\u2009mW/cm 2 , 5\u2009min) and 31 eyes treated with']","['accelerated and standard corneal cross-linking protocols', 'standard corneal cross-linking']","['Uncorrected distance visual acuity improvement', 'Cylinder and spherical equivalent', '4-year changes in vision, refraction, topography, corneal biomechanics, and corneal cell count']","[{'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0332220', 'cui_str': 'Cross-linking (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0332220', 'cui_str': 'Cross-linking (qualifier value)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}]","[{'cui': 'C0429537', 'cui_str': 'Distance visual acuity (observable entity)'}, {'cui': 'C4319645', 'cui_str': 'Cylinder (unit of presentation)'}, {'cui': 'C0332501', 'cui_str': 'Spherical shape (qualifier value)'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0042789', 'cui_str': 'Vision'}, {'cui': 'C0430943', 'cui_str': 'Refraction'}, {'cui': 'C0007584', 'cui_str': 'Cell Number'}]",,0.0477401,"At 4 years after the procedure, standard corneal cross-linking offered better anterior corneal flattening in the center and periphery.","[{'ForeName': 'Hassan', 'Initials': 'H', 'LastName': 'Hashemi', 'Affiliation': 'Noor Research Center for Ophthalmic Epidemiology, Noor Eye Hospital, Tehran, Iran.'}, {'ForeName': 'Masoomeh', 'Initials': 'M', 'LastName': 'Mohebbi', 'Affiliation': 'Eye Research Center, Farabi Eye Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Soheila', 'Initials': 'S', 'LastName': 'Asgari', 'Affiliation': 'Noor Ophthalmology Research Center, Noor Eye Hospital, Tehran, Iran.'}]",European journal of ophthalmology,['10.1177/1120672119839927'] 1127,31589587,Antimicrobial Photodynamic Therapy Using a Chloro-Aluminum Phthalocyanine Adjuvant to Nonsurgical Periodontal Treatment Does Not Improve Clinical Parameters in Patients with Chronic Periodontitis.,"Background and objective: To evaluate the effects of antimicrobial photodynamic therapy (aPDT) with chloro-aluminum phthalocyanine (AlClFc) adjuvant to scaling and root planing (SRP) on periodontal clinical parameters of patients with chronic periodontitis. Materials and methods: Fifty-four periodontal sites were randomly distributed into two groups: 27 in the test group (SRP+aPDT)-using a low-power laser application Photon Lase III (DMC Equipamentos Ltda, São Carlos, São Paulo, Brazil) with operational parameters of 660 nm and 100 mW for 15 sec, and 27 in the control group (SRP). SRP was performed in a single session and the periodontal clinical parameters such as visible plaque index, bleeding on probing (BOP), probing depth (PD), and clinical attachment level were assessed at the baseline (T 0 ) and 3 months after aPDT (T 3 ). Results: Regarding BOP, a decrease in both treatment groups, the test group ( p  = 0.003) and control group ( p  = 0.001), was reported between T 0 and T 3 . A reduction in PD and clinical insertion gain for both treatment groups ( p  < 0.05) after 3 months of therapy was observed, although nonsignificant ( p  > 0.05) in intergroup comparison. Conclusions: aPDT with AlClFc adjuvant to SRP did not provide additional benefits in reducing PD and clinical insertion gain.",2019,"Results: Regarding BOP, a decrease in both treatment groups, the test group ( p  = 0.003) and control group ( p  = 0.001), was reported between T 0 and T 3 .","['Patients with Chronic Periodontitis', 'Materials and methods: Fifty-four periodontal sites', 'patients with chronic periodontitis']","['AlClFc adjuvant to SRP', 'test group (SRP+aPDT)-using a low-power laser application Photon Lase III (DMC Equipamentos Ltda, São Carlos, São Paulo, Brazil) with operational parameters of 660\u2009nm and 100\u2009mW for 15\u2009sec, and 27 in the control group (SRP', 'SRP', 'antimicrobial photodynamic therapy (aPDT) with chloro-aluminum phthalocyanine (AlClFc) adjuvant to scaling and root planing (SRP', 'Antimicrobial Photodynamic Therapy']","['visible plaque index, bleeding on probing (BOP), probing depth (PD), and clinical attachment level', 'PD and clinical insertion gain']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0266929', 'cui_str': 'Adult Periodontitis'}, {'cui': 'C0520510', 'cui_str': 'Material (attribute)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C4517807', 'cui_str': 'Fifty-four'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}]","[{'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0023089', 'cui_str': 'Lasers'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}, {'cui': 'C0086805', 'cui_str': 'Photons'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C4517845', 'cui_str': '660'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1136254', 'cui_str': 'Microbicides'}, {'cui': 'C0031740', 'cui_str': 'Photodynamic Therapy'}, {'cui': 'C0051520', 'cui_str': 'aluminum phthalocyanine'}, {'cui': 'C0222045'}, {'cui': 'C0085287', 'cui_str': 'Root Planings'}]","[{'cui': 'C0205379', 'cui_str': 'Visible (qualifier value)'}, {'cui': 'C0332461', 'cui_str': 'Plaque (morphologic abnormality)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C3179165', 'cui_str': 'Probe (methazole)'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}]",54.0,0.029063,"Results: Regarding BOP, a decrease in both treatment groups, the test group ( p  = 0.003) and control group ( p  = 0.001), was reported between T 0 and T 3 .","[{'ForeName': 'Israel Alexandre de Araújo', 'Initials': 'IAA', 'LastName': 'Sena', 'Affiliation': 'Dentistry Department, Federal University of Rio Grande do Norte, Natal, Rio Grande do Norte, Brazil.'}, {'ForeName': 'Davi Neto de Araújo', 'Initials': 'DNA', 'LastName': 'Silva', 'Affiliation': 'Dentistry Department, Federal University of Rio Grande do Norte, Natal, Rio Grande do Norte, Brazil.'}, {'ForeName': 'Marcela Letícia da Silva', 'Initials': 'MLDS', 'LastName': 'Azevedo', 'Affiliation': 'Dentistry Department, Federal University of Rio Grande do Norte, Natal, Rio Grande do Norte, Brazil.'}, {'ForeName': 'Natália Teixeira', 'Initials': 'NT', 'LastName': 'da Silva', 'Affiliation': 'Dentistry Department, Federal University of Rio Grande do Norte, Natal, Rio Grande do Norte, Brazil.'}, {'ForeName': 'João Paulo Figueiró', 'Initials': 'JPF', 'LastName': 'Longo', 'Affiliation': 'Department of Genetics and Morphology, Institute of Biological Sciences, University of Brasília, Brasília/DF, Brazil.'}, {'ForeName': 'Maiara', 'Initials': 'M', 'LastName': 'de Moraes', 'Affiliation': 'Department of Health Sciences, Center for Biological and Health Sciences, Medicine, Rural Federal University of Semi-Árido (UFERSA), Mossoró, Rio Grande do Norte, Brazil.'}, {'ForeName': 'Ana Rafaela Luz', 'Initials': 'ARL', 'LastName': 'de Aquino Martins', 'Affiliation': 'Dentistry Department, Federal University of Rio Grande do Norte, Natal, Rio Grande do Norte, Brazil.'}]","Photobiomodulation, photomedicine, and laser surgery",['10.1089/photob.2019.4651'] 1128,29037481,Surgical outcomes among elderly women with endometrial cancer treated by laparoscopic hysterectomy: a NRG/Gynecologic Oncology Group study.,"OBJECTIVE Tolerance of and complications caused by minimally invasive hysterectomy and staging in the older endometrial cancer population is largely unknown despite the fact that this is the most rapidly growing age group in the United States. The objective of this retrospective review was to compare operative morbidity by age in patients on the Gynecologic Oncology Group Laparoscopic Surgery or Standard Surgery in Treating Patients With Endometrial Cancer or Cancer of the Uterus (LAP2) trial. STUDY DESIGN This is a retrospective analysis of patients from Gynecologic Oncology Group LAP2, a trial that included clinically early-stage uterine cancer patients randomized to laparotomy vs laparoscopy for surgical staging. Differences in the rates and types of intraoperative and perioperative complications were compared by age. Specifically complications between patients <60 vs ≥60 years old were compared caused by toxicity analysis showing a sharp increase in toxicity starting at age 60 years in the laparotomy group. RESULTS LAP2 included 1477 patients ≥60 years old. As expected, with increasing age there was worsening performance status and disease characteristics including higher rates of serous histology, high-stage disease, and lymphovascular space invasion. There was no significant difference in lymph node dissection rate by age for the entire population or within the laparotomy or laparoscopy groups. Toxicity analysis showed a sharp increase in toxicity seen in patients ≥60 years old in the laparotomy group. Further analysis showed that when comparing laparotomy with laparoscopy in patients <60 years old vs ≥60 years old and controlling for race, body mass index, stage, grade, and performance status, patients <60 years old undergoing laparotomy had more hospital stays >2 days (odds ratio, 17.48; 95% confidence interval, 11.71-27.00, P < .001) compared with patients <60 years old undergoing laparoscopy. However, when comparing laparotomy with laparoscopy in patients ≥60 years old, in addition to hospital stay >2 days (odds ratio, 12.77; 95% confidence interval, 8.74-19.32, P < .001), there were higher rates of the following postoperative complications: antibiotic administration (odds ratio, 1.63; 95% confidence interval, 1.24-2.14, P < .001), ileus (odds ratio, 2.16; 95% confidence interval, 1.42-3.31, P <0.001), pneumonias (odds ratio, 2.36; 95% confidence interval, 1.01-5.66, P = .048), deep vein thromboses (odds ratio, 2.87; 95% confidence interval, 1.08-8.03, P = .035), and arrhythmias (odds ratio, 3.21; 95% confidence interval, 1.60-6.65, P = .001) in the laparotomy group. CONCLUSION Laparoscopic staging for uterine cancer is associated with decreased morbidity in the immediate postoperative period in patients ≥60 years old. These results allow for more accurate preoperative counseling. A minimally invasive approach to uterine cancer staging may decrease morbidity that could affect long-term survival.",2018,There was no significant difference in lymph node dissection rate by age for the entire population or within the laparotomy or laparoscopy groups.,"['patients <60 years old undergoing laparoscopy', 'patients on the', 'patients ≥60 years old in the laparotomy group', 'patients ≥60 years old', 'With Endometrial Cancer or Cancer of the Uterus (LAP2) trial', 'elderly women with endometrial cancer\xa0treated by', '1477 patients ≥60 years old', 'older endometrial cancer population', 'patients from Gynecologic Oncology Group LAP2, a trial that included clinically early-stage uterine cancer patients randomized to']","['laparoscopic hysterectomy', 'Gynecologic Oncology Group Laparoscopic Surgery or Standard Surgery', 'Laparoscopic staging', 'laparotomy vs laparoscopy']","['toxicity starting', 'hospital stays', 'deep vein\xa0thromboses', 'lymph node dissection rate', 'operative morbidity', 'rates and types of intraoperative and perioperative complications', 'postoperative complications: antibiotic administration', 'arrhythmias', 'toxicity seen', 'ileus']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0031150', 'cui_str': 'Celioscopy'}, {'cui': 'C0023038', 'cui_str': 'Laparotomy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0476089', 'cui_str': 'Endometrial Carcinoma'}, {'cui': 'C0153567', 'cui_str': 'Cancer of Uterus'}, {'cui': 'C0524338', 'cui_str': 'Elderly woman (person)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0205480', 'cui_str': 'Gynecologic (qualifier value)'}, {'cui': 'C0297197', 'cui_str': 'lamina-associated polypeptide 2'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C2363430', 'cui_str': 'Early stage (qualifier value)'}]","[{'cui': 'C0404089', 'cui_str': 'Laparoscopic hysterectomy (procedure)'}, {'cui': 'C0205480', 'cui_str': 'Gynecologic (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0751429', 'cui_str': 'Surgical Procedures, Laparoscopic'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0023038', 'cui_str': 'Laparotomy'}, {'cui': 'C0031150', 'cui_str': 'Celioscopy'}]","[{'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0149871', 'cui_str': 'Deep Vein Thrombosis'}, {'cui': 'C0242382', 'cui_str': 'Lymph Node Dissection'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C4545429', 'cui_str': 'Perioperative complication'}, {'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C1258215', 'cui_str': 'Ileus'}]",1477.0,0.293865,There was no significant difference in lymph node dissection rate by age for the entire population or within the laparotomy or laparoscopy groups.,"[{'ForeName': 'Erin A', 'Initials': 'EA', 'LastName': 'Bishop', 'Affiliation': 'Department of Obstetrics and Gynecology, Section of Gynecologic Oncology, University of Oklahoma, Oklahoma City, OK. Electronic address: erbishop@mcw.edu.'}, {'ForeName': 'James J', 'Initials': 'JJ', 'LastName': 'Java', 'Affiliation': 'NRG Oncology Statistics and Data Management Center, Roswell Park Cancer Institute, Buffalo, NY.'}, {'ForeName': 'Kathleen N', 'Initials': 'KN', 'LastName': 'Moore', 'Affiliation': 'Department of Obstetrics and Gynecology, Section of Gynecologic Oncology, University of Oklahoma, Oklahoma City, OK.'}, {'ForeName': 'Nick M', 'Initials': 'NM', 'LastName': 'Spirtos', 'Affiliation': ""Women's Cancer Center, Las Vegas, NV.""}, {'ForeName': 'Michael L', 'Initials': 'ML', 'LastName': 'Pearl', 'Affiliation': 'Department of Gynecologic Oncology, Stony Brook University Hospital, Stony Brook, NY.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Zivanovic', 'Affiliation': 'Division of Gynecologic Oncology, Memorial Sloan-Kettering Cancer Center, New York City, NY.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Kushner', 'Affiliation': 'Department of Gynecologic Oncology, University of Wisconsin-Madison, Madison, WI.'}, {'ForeName': 'Floor', 'Initials': 'F', 'LastName': 'Backes', 'Affiliation': 'Wexner Medical Center, Ohio State University, Hilliard, OH.'}, {'ForeName': 'Chad A', 'Initials': 'CA', 'LastName': 'Hamilton', 'Affiliation': 'Gynecologic Oncology Service, Walter Reed National Military Medical Center, Bethesda, MD.'}, {'ForeName': 'Melissa A', 'Initials': 'MA', 'LastName': 'Geller', 'Affiliation': 'University of Minnesota School of Medicine, Minneapolis, MN.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Hurteau', 'Affiliation': 'Department of Obstetrics and Gynecology, Division of Gynecologic Oncology, University of Chicago Pritzker School of Medicine, NorthShore University Health System, Evanston, IL.'}, {'ForeName': 'Cara', 'Initials': 'C', 'LastName': 'Mathews', 'Affiliation': 'Women and Infants Hospital, Providence, RI.'}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Wenham', 'Affiliation': 'Department of Gynecologic Oncology, H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL.'}, {'ForeName': 'Pedro T', 'Initials': 'PT', 'LastName': 'Ramirez', 'Affiliation': 'Department of Gynecologic Oncology, M. D. Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Zweizig', 'Affiliation': 'Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, University of Massachusetts Medical School, Worcester, MA.'}, {'ForeName': 'Joan L', 'Initials': 'JL', 'LastName': 'Walker', 'Affiliation': 'Department of Obstetrics and Gynecology, Section of Gynecologic Oncology, University of Oklahoma, Oklahoma City, OK.'}]",American journal of obstetrics and gynecology,['10.1016/j.ajog.2017.09.026'] 1129,31580781,Evaluation of the Effects of Er:YAG Laser for the De-Epithelialization of the Palatal Graft in the Treatment of Multiple Gingival Recessions: A Randomized Clinical Trial.,"Objective: The purposes of this split-mouth pilot study were to investigate the efficacy of the Er:YAG laser use for the de-epithelialization of the palatal graft in the treatment of the multiple gingival recessions using the bilaminar procedure and also to evaluate the patient-reported esthetic outcomes after 6 months. Materials and methods: Five systemically healthy participants with total 28 bilateral-multiple adjacent maxillary Miller I recessions were included. The treatment was performed with the bilaminar technique [coronally advanced flap (CAF)+de-epithelialized free gingival graft]. De-epithelialization procedure was done with scalpel (control site) or Er:YAG laser (Versawave, Hoya ConBio, San Francisco, CA; 40 hz, 50 mJ/pulse), under water irrigation, noncontact mode (∼1 mm away from the target tissue) in sweeping motion with chisel-type laser (test site). Root coverage and patient-reported outcomes were evaluated at 6 months after the operations. Results: Clinical outcomes of the both treatment sites did not show any statistically significant differences except for the gingival thickness parameter. However, patient-reported outcomes regarding the esthetic appearance of the gingiva was detected in favor of the Er:YAG laser applied sites. Conclusions: Within the limits of the study, it can be concluded that both de-epithelialization techniques were highly effective at 6 months. However, Er:YAG laser-applied grafted sites revealed more uniform and esthetic gingival appearance compared with scalpel-used grafted sites.",2019,"However, Er:YAG laser-applied grafted sites revealed more uniform and esthetic gingival appearance compared with scalpel-used grafted sites.","['Five systemically healthy participants with total 28 bilateral-multiple adjacent maxillary Miller I recessions were included', 'Multiple Gingival Recessions']","['bilaminar technique [coronally advanced flap (CAF)+de-epithelialized free gingival graft', 'Er:YAG laser', 'scalpel (control site) or Er:YAG laser (Versawave, Hoya ConBio, San Francisco, CA; 40 hz, 50\u2009mJ/pulse), under water irrigation, noncontact mode (∼1\u2009mm away from the target tissue) in sweeping motion with chisel-type laser (test site', 'Er:YAG Laser']","['esthetic appearance of the gingiva', 'uniform and esthetic gingival appearance', 'gingival thickness parameter']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0205117', 'cui_str': 'Juxta-posed (qualifier value)'}, {'cui': 'C0402830', 'cui_str': 'Miller (occupation)'}, {'cui': 'C0333047', 'cui_str': 'Recession (morphologic abnormality)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0017572', 'cui_str': 'Gingival Recession'}]","[{'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0038925', 'cui_str': 'Surgical Flaps'}, {'cui': 'C0398967', 'cui_str': 'Free soft dentoalveolar tissue graft procedure, including donor site (procedure)'}, {'cui': 'C0457903', 'cui_str': 'Erbium YAG Lasers'}, {'cui': 'C0392220', 'cui_str': 'Surgical knife, device (physical object)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0446266', 'cui_str': 'Hoya (organism)'}, {'cui': 'C0036152', 'cui_str': 'San Francisco'}, {'cui': 'C0034107', 'cui_str': 'Pulse'}, {'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C0022100', 'cui_str': 'Lavage'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C0687704', 'cui_str': 'Motions (qualifier value)'}, {'cui': 'C0179899', 'cui_str': 'Chisel, device (physical object)'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0023089', 'cui_str': 'Lasers'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}]","[{'cui': 'C0014901', 'cui_str': 'Esthetics'}, {'cui': 'C0700364', 'cui_str': 'Appearances (qualifier value)'}, {'cui': 'C0017562', 'cui_str': 'Gums'}, {'cui': 'C4019284', 'cui_str': 'Uniforms'}, {'cui': 'C4521854', 'cui_str': 'Gingival (intended site)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",,0.049515,"However, Er:YAG laser-applied grafted sites revealed more uniform and esthetic gingival appearance compared with scalpel-used grafted sites.","[{'ForeName': 'Hare', 'Initials': 'H', 'LastName': 'Gursoy', 'Affiliation': 'Department of Periodontology, Faculty of Dentistry, Yeditepe University, Istanbul, Turkey.'}, {'ForeName': 'Ece', 'Initials': 'E', 'LastName': 'Yarimoglu', 'Affiliation': 'Department of Periodontology, Faculty of Dentistry, Yeditepe University, Istanbul, Turkey.'}, {'ForeName': 'Bahar', 'Initials': 'B', 'LastName': 'Kuru', 'Affiliation': 'Department of Periodontology, Faculty of Dentistry, Yeditepe University, Istanbul, Turkey.'}, {'ForeName': 'Ebru', 'Initials': 'E', 'LastName': 'Ozkan Karaca', 'Affiliation': 'Department of Periodontology, Faculty of Dentistry, Yeditepe University, Istanbul, Turkey.'}, {'ForeName': 'Gizem', 'Initials': 'G', 'LastName': 'Ince Kuka', 'Affiliation': 'Department of Periodontology, Faculty of Dentistry, Yeditepe University, Istanbul, Turkey.'}]","Photobiomodulation, photomedicine, and laser surgery",['10.1089/photob.2019.4681'] 1130,31589558,"Can Photobiomodulation Therapy Be an Alternative to Methylprednisolone in Reducing Pain, Swelling, and Trismus After Removal of Impacted Third Molars?","Background and objective: Studies investigating an alternative to corticosteroids in terms of potential side effects after surgical removal of impacted third molars are still ongoing. Accordingly, the present randomized single-blind study aimed to compare the efficacy of photobiomodulation therapy (PBMT) and methylprednisolone on pain, edema, and trismus after surgical removal of impacted third molars. Methods: The study included 30 healthy patients with bilaterally impacted lower third molars. The side (right or left molar) that would be extracted at first and the treatment (PBMT or corticosteroid) that would be applied to this side were decided by tossing a coin. The time interval between two surgical operations was at least 3 weeks. In the laser group, immediately after the surgical procedure, PBMT was applied extraorally to the insertion point of the masseter muscle for 60 sec with an output power of 0.3 W and an energy density of 6 J/cm 2 and then repeated on postoperative days 1 and 2. In the corticosteroid group, 40 mg/2 mL methylprednisolone sodium succinate was injected postoperatively into the masseter muscle with the intrabuccal approach. On postoperative day 1, methylprednisolone injection (20 mg/1 mL) was repeated. Pain was evaluated using the visual analog scale on postoperative days 1, 2, and 7. Edema (in mm) and trismus (in mm) were evaluated preoperatively and on postoperative days 2 and 7. Results: There were no significant differences between the PBMT and methylprednisolone administration in terms of postoperative pain, edema, and trismus. Conclusions: Within the limits of the present study, PBMT was considered an alternative and a useful method for controlling inflammatory complications following impacted wisdom tooth surgery as it exhibited similar clinical efficacy to that of methylprednisolone.",2019,"There were no significant differences between the PBMT and methylprednisolone administration in terms of postoperative pain, edema, and trismus. ","['after surgical removal of impacted third molars', '30 healthy patients with bilaterally impacted lower third molars']","['methylprednisolone', 'methylprednisolone injection', 'PBMT and methylprednisolone', 'photobiomodulation therapy (PBMT) and methylprednisolone', 'methylprednisolone sodium succinate', 'Methylprednisolone']","['postoperative pain, edema, and trismus', 'Pain, Swelling, and Trismus', 'Edema (in mm) and trismus', 'Pain', 'pain, edema, and trismus', 'time interval']","[{'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0026369', 'cui_str': 'Tooth, Wisdom'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0442051', 'cui_str': 'Lower third (qualifier value)'}, {'cui': 'C0026367', 'cui_str': 'Molar'}]","[{'cui': 'C0025815', 'cui_str': 'Methylprednisolone'}, {'cui': 'C4084437', 'cui_str': 'Methylprednisolone Injection'}, {'cui': 'C4019433', 'cui_str': 'LLLT'}, {'cui': 'C0700546', 'cui_str': 'Methylprednisolone Sodium Succinate'}]","[{'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0013604', 'cui_str': 'Hydrops'}, {'cui': 'C0041105', 'cui_str': 'Trismus'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1272706', 'cui_str': 'Interval'}]",30.0,0.0518546,"There were no significant differences between the PBMT and methylprednisolone administration in terms of postoperative pain, edema, and trismus. ","[{'ForeName': 'Erkan', 'Initials': 'E', 'LastName': 'Feslihan', 'Affiliation': 'Tekirdag Oral and Dental Health Hospital, Tekirdag, Turkey.'}, {'ForeName': 'Cennet Neslihan', 'Initials': 'CN', 'LastName': 'Eroğlu', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Akdeniz University, Antalya, Turkey.'}]","Photobiomodulation, photomedicine, and laser surgery",['10.1089/photob.2019.4696'] 1131,30604373,Effect of TELEmedicine for Inflammatory Bowel Disease on Patient Activation and Self-Efficacy.,"INTRODUCTION Limitations in inflammatory bowel disease (IBD) care necessitate greater patient activation and self-efficacy, measures associated with positive health outcomes. METHODS We assessed change in patient activation and general self-efficacy from baseline to 12 months through our TELEmedicine for IBD trial, a multicenter, randomized controlled trial consisting of a web-based monitoring system that interacts with participants via text messaging. A total of 222 adults with IBD who had experienced an IBD flare within 2 years prior to the trial were randomized into either a control arm that received standard care (SC) or an intervention arm that completed self-testing through the TELE-IBD system every other week (EOW) or weekly (W). RESULTS Changes in self-efficacy scores were not significantly different between control and experimental groups. Patient activation scores were significantly different between standard care and the TELE-IBD EOW group only (p = 0.03). CONCLUSIONS Use of remote monitoring did not improve self-efficacy or patient activation compared to routine care.",2020,"Patient activation scores were significantly different between standard care and the TELE-IBD EOW group only (p = 0.03). ",['222 adults with IBD who had experienced an IBD flare within 2\xa0years prior to the trial'],"['control arm that received standard care (SC) or an intervention arm that completed self-testing through the TELE-IBD system every other week (EOW) or weekly (W', 'TELEmedicine']","['Patient activation scores', 'Patient Activation and Self-Efficacy', 'self-efficacy or patient activation', 'patient activation and general self-efficacy', 'self-efficacy scores']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0021390', 'cui_str': 'Inflammatory Bowel Diseases'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0021390', 'cui_str': 'Inflammatory Bowel Diseases'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0162648', 'cui_str': 'Telemedicine'}]","[{'cui': 'C3853034', 'cui_str': 'Patient Activation'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}]",222.0,0.0406776,"Patient activation scores were significantly different between standard care and the TELE-IBD EOW group only (p = 0.03). ","[{'ForeName': 'Zaid', 'Initials': 'Z', 'LastName': 'Bilgrami', 'Affiliation': 'University of Maryland School of Medicine, 685 West Baltimore Street, Suite 8-00, Baltimore, MD, 21201, USA.'}, {'ForeName': 'Ameer', 'Initials': 'A', 'LastName': 'Abutaleb', 'Affiliation': 'University of Maryland School of Medicine, 685 West Baltimore Street, Suite 8-00, Baltimore, MD, 21201, USA.'}, {'ForeName': 'Kenechukwu', 'Initials': 'K', 'LastName': 'Chudy-Onwugaje', 'Affiliation': 'University of Maryland School of Medicine, 685 West Baltimore Street, Suite 8-00, Baltimore, MD, 21201, USA.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Langenberg', 'Affiliation': 'University of Maryland School of Medicine, 685 West Baltimore Street, Suite 8-00, Baltimore, MD, 21201, USA.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Regueiro', 'Affiliation': 'University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Schwartz', 'Affiliation': 'Vanderbilt University School of Medicine, Nashville, TN, USA.'}, {'ForeName': 'J Kathleen', 'Initials': 'JK', 'LastName': 'Tracy', 'Affiliation': 'University of Maryland School of Medicine, 685 West Baltimore Street, Suite 8-00, Baltimore, MD, 21201, USA.'}, {'ForeName': 'Leyla', 'Initials': 'L', 'LastName': 'Ghazi', 'Affiliation': 'Dartmouth-Hitchcock Medical Center, Lebanon, NH, USA.'}, {'ForeName': 'Seema A', 'Initials': 'SA', 'LastName': 'Patil', 'Affiliation': 'University of Maryland School of Medicine, 685 West Baltimore Street, Suite 8-00, Baltimore, MD, 21201, USA.'}, {'ForeName': 'Sandra M', 'Initials': 'SM', 'LastName': 'Quezada', 'Affiliation': 'University of Maryland School of Medicine, 685 West Baltimore Street, Suite 8-00, Baltimore, MD, 21201, USA.'}, {'ForeName': 'Katharine M', 'Initials': 'KM', 'LastName': 'Russman', 'Affiliation': 'University of Maryland School of Medicine, 685 West Baltimore Street, Suite 8-00, Baltimore, MD, 21201, USA.'}, {'ForeName': 'Charlene C', 'Initials': 'CC', 'LastName': 'Quinn', 'Affiliation': 'University of Maryland School of Medicine, 685 West Baltimore Street, Suite 8-00, Baltimore, MD, 21201, USA.'}, {'ForeName': 'Guruprasad', 'Initials': 'G', 'LastName': 'Jambaulikar', 'Affiliation': ""Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Dawn B', 'Initials': 'DB', 'LastName': 'Beaulieu', 'Affiliation': 'Vanderbilt University School of Medicine, Nashville, TN, USA.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Horst', 'Affiliation': 'Vanderbilt University School of Medicine, Nashville, TN, USA.'}, {'ForeName': 'Raymond K', 'Initials': 'RK', 'LastName': 'Cross', 'Affiliation': 'University of Maryland School of Medicine, 685 West Baltimore Street, Suite 8-00, Baltimore, MD, 21201, USA. rcross@som.umaryland.edu.'}]",Digestive diseases and sciences,['10.1007/s10620-018-5433-5'] 1132,30912160,Randomized controlled trial of the effects of nursing care based on a telephone intervention for medication adherence in schizophrenia.,"PURPOSE Our aim was to determine the effects of ""Telephone Intervention Problem Solving"" (TIPS) on medication adherence among individuals diagnosed with schizophrenia. DESIGN AND METHODS This randomized controlled trial was conducted with 45 patients. TIPS was applied to the intervention group for 2 months, whereas the control group received routine care. FINDINGS We found that the rate of voluntary continuation of medicine (P < 0.001), belief in the necessity of medication (P = 0.008) and medication adherence scores were higher in the intervention group (P < 0.001). PRACTICAL IMPLICATIONS This study may serve as a guide for applying telephone communication to clinical interventions in psychiatric nursing.",2020,"FINDINGS We found that the rate of voluntary continuation of medicine (P < 0.001), belief in the necessity of medication (P = 0.008) and medication adherence scores were higher in the intervention group (P < 0.001). ","['schizophrenia', '45 patients', 'individuals diagnosed with schizophrenia', 'psychiatric nursing']","['control group received routine care', 'telephone intervention', 'nursing care', 'Telephone Intervention Problem Solving"" (TIPS']","['medication adherence', 'rate of voluntary continuation of medicine', 'medication adherence scores']","[{'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0033870', 'cui_str': 'Mental Health Nursing'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0028682', 'cui_str': 'Nursing Care'}, {'cui': 'C3669643', 'cui_str': 'Problem solving (qualifier value)'}]","[{'cui': 'C2364172', 'cui_str': 'Medication Adherence'}, {'cui': 'C0439656', 'cui_str': 'Voluntary (qualifier value)'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",45.0,0.0814288,"FINDINGS We found that the rate of voluntary continuation of medicine (P < 0.001), belief in the necessity of medication (P = 0.008) and medication adherence scores were higher in the intervention group (P < 0.001). ","[{'ForeName': 'Esra', 'Initials': 'E', 'LastName': 'Uslu', 'Affiliation': 'Department of Psychiatric Mental Health Nursing, Faculty of Health Science, Eskisehir Osmangazi University, Eskisehir, Turkey.'}, {'ForeName': 'Kadriye', 'Initials': 'K', 'LastName': 'Buldukoglu', 'Affiliation': 'Department of Psychiatric Mental Health Nursing, Faculty of Nursing, Akdeniz University, Antalya, Turkey.'}]",Perspectives in psychiatric care,['10.1111/ppc.12376'] 1133,30925575,Augmented Subscleral Trabeculectomy With Beta Radiation and Mitomycin C in Egyptian Glaucoma Patients.,"PURPOSE Subscleral trabeculectomy is the most common surgical treatment for glaucoma. However, wound healing and scar formation may result in bleb fibrosis, leading to bleb failure. The healing response of the wound is reported to be the single most important risk factor in determining the final intraocular pressure (IOP) after glaucoma filtration surgery. Thus, we aimed to evaluate the effect of preoperative beta irradiation and intraoperative mitomycin C (MMC) treatment as combined adjuncts to subscleral trabeculectomy in the management of glaucoma in Egyptian patients. PATIENTS AND METHODS This prospective, interventional, comparative masked clinical study was performed between October 2016 and January 2018. This study included 50 subjects, 25 of whom underwent trabeculectomy augmented by MMC intraoperatively and beta radiation preoperatively at the bleb area (patient group #1). The remaining 25 subjects underwent trabeculectomy with MMC alone (control group #2). Beta radiation was administered 5 to 7 days before the surgery as a single dose (1000 cGy) using a strontium-90 probe. MMC (0.2 mg/mL) was administered for 2 minutes. RESULTS There was a statistically significant difference in postoperative IOP between the groups from the second week. Intraoperative hyphema occurred in 6 cases in the control group #2, whereas no intraoperative hyphema was observed in patient group #1; this difference was statistically significant. CONCLUSIONS Subscleral trabeculectomy augmented by beta radiation and MMC gives greater control over IOP. Therefore, we recommend using beta radiation before trabeculectomy in patients who may have a high risk of developing conjunctival fibrosis.",2019,"Intraoperative hyphema occurred in 6 cases in the control group #2, whereas no intraoperative hyphema was observed in patient group #1; this difference was statistically significant. ","['50 subjects, 25 of whom underwent trabeculectomy augmented by MMC intraoperatively and beta radiation preoperatively at the bleb area (patient group #1', 'Egyptian patients', 'patients who may have a high risk of developing conjunctival fibrosis', 'Egyptian Glaucoma Patients', 'October 2016 and January 2018']","['preoperative beta irradiation and intraoperative mitomycin C (MMC', 'Subscleral Trabeculectomy With Beta Radiation and Mitomycin C', 'subscleral trabeculectomy', 'Beta radiation', 'MMC', 'trabeculectomy with MMC', 'Subscleral trabeculectomy']","['healing response', 'intraoperative hyphema', 'Intraoperative hyphema', 'wound healing and scar formation', 'postoperative IOP']","[{'cui': 'C3263686', 'cui_str': 'Ocular trabeculectomy'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C2607955', 'cui_str': 'Beta Rays'}, {'cui': 'C3714607', 'cui_str': 'Filtering bleb'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0337801', 'cui_str': 'Egyptians (ethnic group)'}, {'cui': 'C0332167', 'cui_str': 'High risk of (contextual qualifier) (qualifier value)'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C2242746', 'cui_str': 'Glaucoma (SMQ)'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0330390', 'cui_str': 'Beta (organism)'}, {'cui': 'C1282930', 'cui_str': 'Irradiation (physical force)'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0002475', 'cui_str': 'Mitomycin'}, {'cui': 'C3263686', 'cui_str': 'Ocular trabeculectomy'}, {'cui': 'C2607955', 'cui_str': 'Beta Rays'}]","[{'cui': 'C0043240', 'cui_str': 'Wound Healing'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative (qualifier value)'}, {'cui': 'C0020581', 'cui_str': 'Hyphema'}, {'cui': 'C0008767', 'cui_str': 'Cicatrization'}, {'cui': 'C0439634', 'cui_str': 'Formations (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}]",50.0,0.0399427,"Intraoperative hyphema occurred in 6 cases in the control group #2, whereas no intraoperative hyphema was observed in patient group #1; this difference was statistically significant. ","[{'ForeName': 'Hesham M', 'Initials': 'HM', 'LastName': 'El Mazar', 'Affiliation': 'Ophthalmology Department, Faculty of Medicine, Menoufia University, Menoifia.'}, {'ForeName': 'Sameh S', 'Initials': 'SS', 'LastName': 'Mandour', 'Affiliation': 'Ophthalmology Department, Faculty of Medicine, Menoufia University, Menoifia.'}, {'ForeName': 'Mohamed I', 'Initials': 'MI', 'LastName': 'Mostafa', 'Affiliation': 'Ophthalmology in Mataria Teaching Hospital, Cairo, Egypt.'}, {'ForeName': 'Osama A', 'Initials': 'OA', 'LastName': 'Elmorsy', 'Affiliation': 'Ophthalmology Department, Faculty of Medicine, Menoufia University, Menoifia.'}]",Journal of glaucoma,['10.1097/IJG.0000000000001255'] 1134,31887225,"A head-to-head comparison of ixekizumab vs. guselkumab in patients with moderate-to-severe plaque psoriasis: 12-week efficacy, safety and speed of response from a randomized, double-blinded trial.","BACKGROUND Patients with psoriasis value rapid and complete skin clearance. No head-to-head studies have focused on early responses to interleukin (IL)-17 vs. IL-23 inhibitors. OBJECTIVES To compare early and complete skin clearance by the IL-17A inhibitor ixekizumab vs. the IL-23p19 inhibitor guselkumab. METHODS IXORA-R, a 24-week, randomized, double-blinded study, enrolled adults with moderate-to-severe plaque psoriasis [static Physician's Global Assessment of Disease (sPGA) score of ≥ 3, Psoriasis Area and Severity Index (PASI) ≥ 12, and ≥ 10% body surface area]. Patients were randomized (1 : 1) to receive the approved dose of subcutaneous ixekizumab or guselkumab. Primary end point was 100% improvement in PASI (PASI 100) at week 12. Major secondary end points included other levels of improved PASI and sPGA at different time points. Comparisons were made using the Cochran-Mantel-Haenszel test with a multiple testing strategy. Nonresponder imputation was used for missing data. After the completion of the study, the final secondary end point (PASI 100 at 24 weeks) and safety data through week 24 will be reported. RESULTS In total, 1027 patients were randomized. The primary end point PASI 100 at week 12 was met [215/520 ixekizumab (41%); 126/507 guselkumab (25%); P < 0·001]. All major secondary end points measured up to week 12 were met, including PASI 50 at week 1 and PASI 75 at week 2. Serious adverse event frequency was 3% for each group; no new safety signals were identified. CONCLUSIONS Ixekizumab was superior to guselkumab for rapidly improving signs and symptoms in patients with moderate-to-severe plaque psoriasis by week 12. Adverse events were similar to previous ixekizumab and guselkumab studies. Compared with the IL-23 inhibitor guselkumab, ixekizumab can offer complete skin clearance more rapidly to patients with moderate-to-severe plaque psoriasis. What's already known about this topic? Patients with plaque psoriasis desire both high levels of clearance and rapid onset of treatment effects. Ixekizumab, a high-affinity monoclonal antibody that selectively targets interleukin (IL)-17A, has demonstrated greater and faster skin clearance than etanercept and ustekinumab, with consistent long-term efficacy, safety and durability of response. Clinical trial data and systematic reviews have suggested that IL-17 inhibitors can improve a patient's psoriasis more rapidly than IL-23 inhibitors. What does this study add? The head-to-head study design directly compares the efficacy and speed of response of ixekizumab and the IL-23 inhibitor guselkumab in moderate-to-severe plaque psoriasis. The primary end point was met, showing superiority of ixekizumab over guselkumab for achieving complete skin clearance at week 12. The safety profile of ixekizumab was consistent with previous studies. Ixekizumab can deliver patients complete skin clearance and improved quality of life more rapidly than guselkumab.",2020,"No head-to-head studies have focused on early responses to interleukin (IL)-17 versus IL-23 inhibitors. ","['Patients with psoriasis value rapid and complete skin clearance', 'patients with moderate-to-severe plaque psoriasis', 'Patients with Moderate-to-Severe Plaque Psoriasis', ""enrolled adults with moderate-to-severe plaque psoriasis (static Physician's Global Assessment of Disease [sPGA] score of ≥3, Psoriasis Area and Severity Index [PASI] ≥12, and ≥10% body surface area"", '1027 patients were randomised']","['Ixekizumab Versus Guselkumab', 'IL-23 inhibitor guselkumab, ixekizumab', 'subcutaneous ixekizumab or guselkumab', 'Ixekizumab']","['levels of improved PASI and sPGA', 'PASI', 'Adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0406317', 'cui_str': 'Plaque psoriasis (disorder)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0441463', 'cui_str': 'Static (qualifier value)'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0005902', 'cui_str': 'Body Surface Area'}]","[{'cui': 'C3489764', 'cui_str': 'ixekizumab'}, {'cui': 'C3852217', 'cui_str': 'guselkumab'}, {'cui': 'C0963088', 'cui_str': 'IL-23'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C1522438', 'cui_str': 'SC use'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",1027.0,0.26019,"No head-to-head studies have focused on early responses to interleukin (IL)-17 versus IL-23 inhibitors. ","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Blauvelt', 'Affiliation': 'Oregon Medical Research Center, Portland, OR, U.S.A.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Papp', 'Affiliation': 'Probity Medical Research, Inc., Waterloo, Ontario, Canada.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Gottlieb', 'Affiliation': 'Department of Dermatology, Icahn School of Medicine at Mount Sinai, New York, NY, U.S.A.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Jarell', 'Affiliation': 'Northeast Dermatology Associates, Portsmouth, NH, U.S.A.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Reich', 'Affiliation': 'Translational Research in Inflammatory Skin Diseases, Institute for Health Services Research in Dermatology and Nursing, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Maari', 'Affiliation': 'Innovaderm Research, Montreal, QC, Canada.'}, {'ForeName': 'K B', 'Initials': 'KB', 'LastName': 'Gordon', 'Affiliation': 'Medical College of Wisconsin, Milwaukee, WI, U.S.A.'}, {'ForeName': 'L K', 'Initials': 'LK', 'LastName': 'Ferris', 'Affiliation': 'Department of Dermatology, University of Pittsburgh, Pittsburgh, PA, U.S.A.'}, {'ForeName': 'R G', 'Initials': 'RG', 'LastName': 'Langley', 'Affiliation': 'Dalhousie University, Halifax, Nova Scotia, Canada.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Tada', 'Affiliation': 'Department of Dermatology, Teikyo University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'R G', 'Initials': 'RG', 'LastName': 'Lima', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, U.S.A.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Elmaraghy', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, U.S.A.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Gallo', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, U.S.A.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Renda', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, U.S.A.'}, {'ForeName': 'S Y', 'Initials': 'SY', 'LastName': 'Park', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, U.S.A.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Burge', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, U.S.A.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Bagel', 'Affiliation': 'Psoriasis Treatment Center of Central New Jersey, East Windsor, NJ, U.S.A.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The British journal of dermatology,['10.1111/bjd.18851'] 1135,32407216,Randomized Phase III Study of Pemetrexed Plus Cisplatin Versus Vinorelbine Plus Cisplatin for Completely Resected Stage II to IIIA Nonsquamous Non-Small-Cell Lung Cancer.,"PURPOSE To evaluate the efficacy of pemetrexed plus cisplatin versus vinorelbine plus cisplatin as postoperative adjuvant chemotherapy in patients with pathologic stage II-IIIA nonsquamous non-small-cell lung cancer (NSCLC). PATIENTS AND METHODS We performed a randomized, open-label, phase III study at 50 institutions within 7 clinical study groups in Japan. Patients with completely resected pathologic stage II-IIIA (TNM 7th edition) nonsquamous NSCLC were randomly assigned to receive either pemetrexed (500 mg/m 2 , day 1) plus cisplatin (75 mg/m 2 , day 1) or vinorelbine (25 mg/m 2 , days 1 and 8) plus cisplatin (80 mg/m 2 , day 1) with stratification by sex, age, pathologic stage, EGFR mutation, and institution. These treatments were planned to be given every 3 weeks for 4 cycles. The primary end point was recurrence-free survival in the modified intent-to-treat population, excluding ineligible patients. RESULT Between March 2012 and August 2016, 804 patients were enrolled (402 assigned to vinorelbine plus cisplatin and 402 assigned to pemetrexed plus cisplatin). Of 784 eligible patients, 410 (52%) had stage IIIA disease and 192 (24%) had EGFR -sensitive mutations. At a median follow-up of 45.2 months, median recurrence-free survival was 37.3 months for vinorelbine plus cisplatin and 38.9 months for pemetrexed plus cisplatin, with a hazard ratio of 0.98 (95% CI, 0.81 to 1.20; 1-sided P = .474). Grade 3-4 toxicities reported more frequently for vinorelbine plus cisplatin than for pemetrexed plus cisplatin were febrile neutropenia (11.6% v 0.3%, respectively), neutropenia (81.1% v 22.7%, respectively), and anemia (9.3% v 2.8%, respectively). One treatment-related death occurred in each arm. CONCLUSION Although this study failed to show the superiority of pemetrexed plus cisplatin for patients with resected nonsquamous NSCLC, this regimen showed a better tolerability as adjuvant chemotherapy.",2020,"Grade 3-4 toxicities reported more frequently for vinorelbine plus cisplatin than for pemetrexed plus cisplatin were febrile neutropenia (11.6% v 0.3%, respectively), neutropenia (81.1% v 22.7%, respectively), and anemia (9.3% v 2.8%, respectively).","['nonsquamous NSCLC', 'patients with pathologic stage II-IIIA nonsquamous non-small-cell lung cancer (NSCLC', 'We performed a randomized, open-label, phase III study at 50 institutions within 7 clinical study groups in Japan', '784 eligible patients, 410 (52%) had stage IIIA disease and 192 (24%) had EGFR -sensitive mutations', 'Completely Resected Stage II to IIIA Nonsquamous Non-Small-Cell Lung Cancer', 'Between March 2012 and August 2016, 804 patients were enrolled (402 assigned to', 'patients with resected nonsquamous NSCLC', 'Patients with completely resected pathologic stage II-IIIA (TNM 7th edition']","['vinorelbine', 'Pemetrexed Plus Cisplatin Versus Vinorelbine Plus Cisplatin', 'cisplatin', 'vinorelbine plus cisplatin', 'pemetrexed plus cisplatin', 'vinorelbine plus cisplatin and 402 assigned to pemetrexed plus cisplatin', 'pemetrexed']","['febrile neutropenia', 'neutropenia', 'death', 'anemia', 'recurrence-free survival', 'Grade 3-4 toxicities', 'median recurrence-free survival']","[{'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1320480', 'cui_str': 'Pathologic stage'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0282461', 'cui_str': 'Clinical Trials, Phase 3 as Topic'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0332285', 'cui_str': 'In'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0456598', 'cui_str': 'Stage 3A'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C4517623', 'cui_str': '192'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0039694', 'cui_str': 'Tetranitromethane'}, {'cui': 'C0441792', 'cui_str': 'Editions'}]","[{'cui': 'C0078257', 'cui_str': 'vinorelbine'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}]","[{'cui': 'C0746883', 'cui_str': 'Febrile neutropenia'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C2919733', 'cui_str': 'Surviving free of recurrence of neoplastic disease'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",804.0,0.219795,"Grade 3-4 toxicities reported more frequently for vinorelbine plus cisplatin than for pemetrexed plus cisplatin were febrile neutropenia (11.6% v 0.3%, respectively), neutropenia (81.1% v 22.7%, respectively), and anemia (9.3% v 2.8%, respectively).","[{'ForeName': 'Hirotsugu', 'Initials': 'H', 'LastName': 'Kenmotsu', 'Affiliation': 'Division of Thoracic Oncology, Shizuoka Cancer Center, Nagaizumi-cho Sunto-gun, Japan.'}, {'ForeName': 'Nobuyuki', 'Initials': 'N', 'LastName': 'Yamamoto', 'Affiliation': 'Internal Medicine III, Wakayama Medical University, Wakayama, Japan.'}, {'ForeName': 'Takeharu', 'Initials': 'T', 'LastName': 'Yamanaka', 'Affiliation': 'Department of Biostatistics, Yokohama City University School of Medicine, Yokohama, Japan.'}, {'ForeName': 'Katsuo', 'Initials': 'K', 'LastName': 'Yoshiya', 'Affiliation': 'Department of Chest Surgery, Niigata Cancer Center Hospital, Niigata, Japan.'}, {'ForeName': 'Toshiaki', 'Initials': 'T', 'LastName': 'Takahashi', 'Affiliation': 'Division of Thoracic Oncology, Shizuoka Cancer Center, Nagaizumi-cho Sunto-gun, Japan.'}, {'ForeName': 'Tsuyoshi', 'Initials': 'T', 'LastName': 'Ueno', 'Affiliation': 'Department of Thoracic Surgery, National Hospital Organization, Shikoku Cancer Center, Matsuyama, Japan.'}, {'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Goto', 'Affiliation': 'Department of Thoracic Oncology, National Cancer Center Hospital East, Kashiwa, Japan.'}, {'ForeName': 'Haruko', 'Initials': 'H', 'LastName': 'Daga', 'Affiliation': 'Department of Medical Oncology, Osaka City General Hospital, Osaka, Japan.'}, {'ForeName': 'Norihiko', 'Initials': 'N', 'LastName': 'Ikeda', 'Affiliation': 'Department of Surgery, Tokyo Medical University, Tokyo, Japan.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Sugio', 'Affiliation': 'Department of Thoracic and Breast Surgery, Oita University, Oita, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Seto', 'Affiliation': 'Department of Thoracic Oncology, National Hospital Organization Kyushu Cancer Center, Fukuoka, Japan.'}, {'ForeName': 'Shinichi', 'Initials': 'S', 'LastName': 'Toyooka', 'Affiliation': 'Department of General Thoracic Surgery, Breast and Endocrinological Surgery, Okayama University, Okayama, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Date', 'Affiliation': 'Department of Thoracic Surgery, Kyoto University Graduate School of Medicine, Kyoto, Japan.'}, {'ForeName': 'Tetsuya', 'Initials': 'T', 'LastName': 'Mitsudomi', 'Affiliation': 'Division of Thoracic Surgery, Department of Surgery, Kindai University Faculty of Medicine, Osaka-Sayama, Japan.'}, {'ForeName': 'Isamu', 'Initials': 'I', 'LastName': 'Okamoto', 'Affiliation': 'Research Institute for Diseases of the Chest, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.'}, {'ForeName': 'Kohei', 'Initials': 'K', 'LastName': 'Yokoi', 'Affiliation': 'Department of Thoracic Surgery, Nagoya University Graduate School of Medicine, Nagoya, Japan.'}, {'ForeName': 'Hideo', 'Initials': 'H', 'LastName': 'Saka', 'Affiliation': 'Department of Respiratory Medicine, National Hospital Organization Nagoya Medical Center, Nagoya, Japan.'}, {'ForeName': 'Hiroaki', 'Initials': 'H', 'LastName': 'Okamoto', 'Affiliation': ""Department of Respiratory Medicine, Yokohama Municipal Citizen's Hospital, Yokohama, Japan.""}, {'ForeName': 'Yuichi', 'Initials': 'Y', 'LastName': 'Takiguchi', 'Affiliation': 'Department of Medical Oncology, Chiba University Hospital, Chiba, Japan.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Tsuboi', 'Affiliation': 'Division of Thoracic Surgery, National Cancer Center Hospital East, Kashiwa, Japan.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.02674'] 1136,31846898,Psychogenic nonepileptic seizures that remit when the diagnosis is given: Just good luck?,"OBJECTIVE Some patients with psychogenic nonepileptic seizures (PNES) remit when given the diagnosis. It is not realistically possible to test this potential therapeutic effect in an Randomized Controlled Trial (RCT) so we aim to statistically demonstrate it using the temporal relationship between the communication of the diagnosis and the timing of remission. METHOD Re-analysis of data from a study of PNES, where diagnosis was communicated, and outcomes recorded in 54 patients. Making conservative assumptions and using the binomial distribution, the Poisson distribution and the chi-squared test distribution, we calculated likelihoods of the null hypothesis: that communication of the diagnosis and remission of seizures had occurred in random temporal relationship. RESULTS Remission occurred in the week following communication of the diagnosis in 15 out of 54 patients. The χ 2 test assigned this result a p value of <0.00001. Binomial and Poisson distribution calculations also indicated that remission was highly unlikely to have occurred by chance and that, in a dataset similar to ours, was unlikely to be due to chance if occurring in more than 9 patients (16.7%). CONCLUSIONS We showed that the observed remissions were highly unlikely to be due to chance. Where an intervention is 'short and sharp' and the outcome can be measured with reasonable temporal acuity, then this type of method may provide an alternative to RCT methodology when the latter is impracticable.",2020,"RESULTS Remission occurred in the week following communication of the diagnosis in 15 out of 54 patients.","['54 patients', 'patients with psychogenic nonepileptic seizures (PNES']",[],"['Remission', 'Psychogenic nonepileptic seizures']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0458006', 'cui_str': 'Psychogenic (qualifier value)'}, {'cui': 'C3495874', 'cui_str': 'Nonepileptic Seizures'}]",[],"[{'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0458006', 'cui_str': 'Psychogenic (qualifier value)'}, {'cui': 'C3495874', 'cui_str': 'Nonepileptic Seizures'}]",54.0,0.0697693,"RESULTS Remission occurred in the week following communication of the diagnosis in 15 out of 54 patients.","[{'ForeName': 'Roderick', 'Initials': 'R', 'LastName': 'Duncan', 'Affiliation': 'Christchurch Hospital, Christchurch 4710, New Zealand. Electronic address: Roderick.duncan@cdhb.health.nz.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Horwood', 'Affiliation': 'Department of Psychological Medicine, University of Otago Christchurch, New Zealand.'}, {'ForeName': 'Saif', 'Initials': 'S', 'LastName': 'Razvi', 'Affiliation': 'Queen Elizabeth University Hospital, Glasgow G51 4TF, UK.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Mulhern', 'Affiliation': 'Ayrshire Central Hospital, Irvine KA12 8SS, UK.'}]",Epilepsy & behavior : E&B,['10.1016/j.yebeh.2019.106667'] 1137,30893070,"Increased Human Growth Hormone After Oral Consumption of an Amino Acid Supplement: Results of a Randomized, Placebo-Controlled, Double-Blind, Crossover Study in Healthy Subjects.","BACKGROUND Human growth hormone (hGH) is best known for influencing bone and muscle growth, as well as body composition, but the use of recombinant hGH is controversial. Amino acids are a potentially safer alternative; however, preliminary investigations of the effects of oral amino acids on hGH release have been inconclusive. Therefore, we tested the effects of a novel blend of amino acids optimized to increase hGH release. STUDY QUESTION Does an investigational amino acid supplement affect hGH release? STUDY DESIGN This was a randomized, placebo-controlled, double-blind, crossover study that included 16 (12 men, 4 women; age 32 ± 14 years; body mass index 26.4 ± 5.0 kg/m) healthy participants. All participants received both placebo and the amino acid supplement after an overnight fast and completed all study visits. Treatment order was randomized, and each treatment was separated by a 1-week washout period. MEASURES AND OUTCOMES The primary outcomes were the percent change in hGH from baseline to 120 minutes and the area under the curve of hGH over baseline. Serum hGH was measured using enzyme-linked immunosorbent assay at baseline and 15, 30, 60, 90, and 120 minutes. RESULTS At 120 minutes, hGH levels increased by 682% (8-fold) from baseline and were significantly higher than placebo (P = 0.01). In addition, a significantly higher mean area under the curve was observed for the amino acid supplement compared with the placebo [20.4 (95% confidence interval, 19.9-21.0 ng/mL) vs. 19.7 (95% confidence interval, 18.7-20.6 ng/mL); P = 0.04]. CONCLUSIONS These results show that a single dose of the oral amino acid supplement was sufficient to significantly increase hGH levels in healthy adult men and women. CLINICAL TRIAL REGISTRY:: clinicaltrials.gov NCT01540773.",2020,"At 120 minutes, hGH levels increased by 682% (8-fold) from baseline and were significantly higher than placebo (P = 0.01).","['Healthy Subjects', 'included 16 (12 men, 4 women; age 32 ± 14 years; body mass index 26.4 ± 5.0 kg/m) healthy participants', 'healthy adult men and women']","['placebo', 'placebo and the amino acid supplement', 'Placebo', 'Human growth hormone (hGH', 'oral amino acid supplement', 'amino acids', 'Amino Acid Supplement']","['Serum hGH', 'hGH release', 'hGH levels', 'Human Growth Hormone', 'percent change in hGH from baseline to 120 minutes and the area under the curve of hGH']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0556082', 'cui_str': 'Amino acid supplement'}, {'cui': 'C3714500', 'cui_str': 'Somatotropin (Human)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C3539946', 'cui_str': 'Amino acids'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C3714500', 'cui_str': 'Somatotropin (Human)'}, {'cui': 'C0439165', 'cui_str': 'Percent (property) (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0376690', 'cui_str': 'AUC'}]",,0.610075,"At 120 minutes, hGH levels increased by 682% (8-fold) from baseline and were significantly higher than placebo (P = 0.01).","[{'ForeName': 'Charmaine S', 'Initials': 'CS', 'LastName': 'Tam', 'Affiliation': 'Pennington Biomedical Research Center, LSU System, Baton Rouge, LA.'}, {'ForeName': 'William D', 'Initials': 'WD', 'LastName': 'Johnson', 'Affiliation': 'Pennington Biomedical Research Center, LSU System, Baton Rouge, LA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Rood', 'Affiliation': 'Pennington Biomedical Research Center, LSU System, Baton Rouge, LA.'}, {'ForeName': 'Amy L', 'Initials': 'AL', 'LastName': 'Heaton', 'Affiliation': 'Pennington Biomedical Research Center, LSU System, Baton Rouge, LA.'}, {'ForeName': 'Frank L', 'Initials': 'FL', 'LastName': 'Greenway', 'Affiliation': 'Pennington Biomedical Research Center, LSU System, Baton Rouge, LA.'}]",American journal of therapeutics,['10.1097/MJT.0000000000000893'] 1138,30895201,No Significant Changes to Residual Viremia After Switch to Dolutegravir and Lamivudine in a Randomized Trial.,"In the ASPIRE trial, antiretroviral therapy (ART) switch to dolutegravir plus lamivudine (DTG+3TC) was comparable to 3-drug ART in maintaining viral suppression by standard viral load assays. We used an ultrasensitive assay to assess whether this switch led to increased residual viremia. At entry, levels of residual viremia did not differ significantly between arms (DTG+3TC vs 3-drug ART: mean, 5.0 vs 4.2 HIV-1 RNA copies/mL; P = .64). After randomization, no significant between-group differences were found at either week 24 or 48. These results show no evidence for increased viral replication on DTG+3TC and support its further investigation as a dual ART strategy.",2019,"At entry, levels of residual viremia did not differ significantly between arms (DTG+3TC vs 3-drug ART:",[],"['lamivudine (DTG+3TC', 'DTG+3TC vs 3-drug ART', 'Dolutegravir and Lamivudine']","['residual viremia', 'Residual Viremia', 'levels of residual viremia']",[],"[{'cui': 'C0209738', 'cui_str': 'Lamivudine'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C3253985', 'cui_str': 'dolutegravir'}]","[{'cui': 'C1609982', 'cui_str': 'Residual (qualifier value)'}, {'cui': 'C0042749', 'cui_str': 'Viremia'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",,0.0504347,"At entry, levels of residual viremia did not differ significantly between arms (DTG+3TC vs 3-drug ART:","[{'ForeName': 'Jonathan Z', 'Initials': 'JZ', 'LastName': 'Li', 'Affiliation': ""Division of Infectious Diseases, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachussetts.""}, {'ForeName': 'Paul E', 'Initials': 'PE', 'LastName': 'Sax', 'Affiliation': ""Division of Infectious Diseases, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachussetts.""}, {'ForeName': 'Vincent C', 'Initials': 'VC', 'LastName': 'Marconi', 'Affiliation': 'Division of Infectious Diseases, Emory University School of Medicine and Rollins School of Public Health, Atlanta, Georgia.'}, {'ForeName': 'Jesse', 'Initials': 'J', 'LastName': 'Fajnzylber', 'Affiliation': ""Division of Infectious Diseases, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachussetts.""}, {'ForeName': 'Baiba', 'Initials': 'B', 'LastName': 'Berzins', 'Affiliation': 'Division of Infectious Diseases, Northwestern University, Chicago, Illinois.'}, {'ForeName': 'Amesika N', 'Initials': 'AN', 'LastName': 'Nyaku', 'Affiliation': 'Division of Infectious Diseases, Rutgers University, Newark, New Jersey.'}, {'ForeName': 'Carl J', 'Initials': 'CJ', 'LastName': 'Fichtenbaum', 'Affiliation': 'Division of Infectious Diseases, University of Cincinnati, Cincinnati, Ohio.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Wilkin', 'Affiliation': 'Division of Infectious Diseases, Weill Cornell Medicine, New York, New York.'}, {'ForeName': 'Constance A', 'Initials': 'CA', 'LastName': 'Benson', 'Affiliation': 'Division of Infectious Diseases, University of California, San Diego, California.'}, {'ForeName': 'Susan L', 'Initials': 'SL', 'LastName': 'Koletar', 'Affiliation': 'Division of Infectious Diseases, Ohio State University, Columbus, Ohio.'}, {'ForeName': 'Ramon', 'Initials': 'R', 'LastName': 'Lorenzo-Redondo', 'Affiliation': 'Division of Infectious Diseases, Northwestern University, Chicago, Illinois.'}, {'ForeName': 'Babafemi O', 'Initials': 'BO', 'LastName': 'Taiwo', 'Affiliation': 'Division of Infectious Diseases, Northwestern University, Chicago, Illinois.'}]",Open forum infectious diseases,['10.1093/ofid/ofz056'] 1139,31708447,"A support programme for secondary prevention in patients with transient ischaemic attack and minor stroke (INSPiRE-TMS): an open-label, randomised controlled trial.","BACKGROUND Patients with recent stroke or transient ischaemic attack are at high risk for a further vascular event, possibly leading to permanent disability or death. Although evidence-based treatments for secondary prevention are available, many patients do not achieve recommended behavioural modifications and pharmaceutical prevention targets in the long-term. We aimed to investigate whether a support programme for enhanced secondary prevention can reduce the frequency of recurrent vascular events. METHODS INSPiRE-TMS was an open-label, multicentre, international randomised controlled trial done at seven German hospitals with acute stroke units and a Danish stroke centre. Patients with non-disabling stroke or transient ischaemic attack within 2 weeks from study enrolment and at least one modifiable risk factor (ie, arterial hypertension, diabetes, atrial fibrillation, or smoking) were included. Computerised randomisation was used to allocate patients (1:1) either to the support programme in addition to conventional care or to conventional care alone. The support programme used feedback and motivational interviewing strategies with eight outpatient visits over 2 years aiming to improve adherence to secondary prevention targets. The primary outcome was the composite of major vascular events consisting of stroke, acute coronary syndrome, and vascular death, assessed in the intention-to-treat population (all patients who underwent randomisation, did not withdraw study participation, and had at least one follow-up). Outcomes were assessed at annual follow-ups using time-to-first-event analysis. All-cause death was monitored as a safety outcome. This trial is registered with ClinicalTrials.gov, NCT01586702. FINDINGS From Aug 22, 2011, to Oct 30, 2017, we enrolled 2098 patients. Of those, 1048 (50·0%) were randomly assigned to the support programme group and 1050 (50·0%) patients were assigned to the conventional care group. 1030 (98·3%) patients in the support group and 1042 (99·2%) patients in the conventional care group were included in the intention-to-treat analysis. The mean age of analysed participants was 67·4 years and 700 (34%) were women. After a mean follow-up of 3·6 years, the primary outcome of major vascular events had occurred in 163 (15·8%) of 1030 patients of the support programme group and in 175 (16·8%) of 1042 patients of the conventional care group (hazard ratio [HR] 0·92, 95% CI 0·75-1·14). Total major vascular event numbers were 209 for the support programme group and 225 for the conventional care group (incidence rate ratio 0·93, 95% CI 0·77-1·12; p=0·46) and all-cause death occurred in 73 (7·1%) patients in the support programme group and 85 (8·2%) patients in the conventional care group (HR 0·85, 0·62-1·17). More patients in the support programme group achieved secondary prevention targets (eg, in 1-year-follow-up 52% vs 42% [p<0·0001] for blood pressure, 62% vs 54% [p=0·0010] for LDL, 33% vs 19% [p<0·0001] for physical activity, and 51% vs 34% [p=0·0010] for smoking cessation). INTERPRETATION Provision of an intensified secondary prevention programme in patients with non-disabling stroke or transient ischaemic attack was associated with improved achievement of secondary prevention targets but did not lead to a significantly lower rate of major vascular events. Further research is needed to investigate the effects of support programmes in selected patients who do not achieve secondary prevention targets soon after discharge. FUNDING German Federal Ministry of Education and Research, Pfizer, and German Stroke Foundation.",2020,"Total major vascular event numbers were 209 for the support programme group and 225 for the conventional care group (incidence rate ratio 0·93, 95% CI 0·77-1·12; p=0·46) and all-cause death occurred in 73 (7·1%) patients in the support programme group and 85 (8·2%) patients in the conventional care group (HR 0·85, 0·62-1·17).","['From Aug 22, 2011, to Oct 30, 2017, we enrolled 2098 patients', 'seven German hospitals with acute stroke units and a Danish stroke centre', '1030 (98·3%) patients in the support group and 1042 (99·2%) patients in the conventional care group were included in the intention-to-treat analysis', 'Patients with recent stroke or transient ischaemic attack', 'The mean age of analysed participants was 67·4 years and 700 (34%) were women', 'Patients with non-disabling stroke or transient ischaemic attack within 2 weeks from study enrolment and at least one modifiable risk factor (ie, arterial hypertension, diabetes, atrial fibrillation, or smoking) were included', 'patients with transient ischaemic attack and minor stroke (INSPiRE-TMS', 'selected patients who do not achieve secondary prevention targets soon after discharge', 'patients with non-disabling stroke or transient ischaemic attack']","['support programme in addition to conventional care or to conventional care alone', 'conventional care group']","['major vascular events', 'blood pressure', 'secondary prevention targets', 'physical activity', 'composite of major vascular events consisting of stroke, acute coronary syndrome, and vascular death, assessed in the intention-to-treat population', 'cause death', 'Total major vascular event numbers']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C1556085', 'cui_str': 'Germans (ethnic group)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0751956', 'cui_str': 'Stroke, Acute'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0036606', 'cui_str': 'Support Groups'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C0007787', 'cui_str': 'Brain TIA'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517862', 'cui_str': '700 (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0221464', 'cui_str': 'Arterial (qualifier value)'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0026193', 'cui_str': 'Minors'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0679699', 'cui_str': 'Disease Prevention, Secondary'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}]","[{'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0679699', 'cui_str': 'Disease Prevention, Secondary'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0948089', 'cui_str': 'Acute Coronary Syndrome'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}]",2098.0,0.159218,"Total major vascular event numbers were 209 for the support programme group and 225 for the conventional care group (incidence rate ratio 0·93, 95% CI 0·77-1·12; p=0·46) and all-cause death occurred in 73 (7·1%) patients in the support programme group and 85 (8·2%) patients in the conventional care group (HR 0·85, 0·62-1·17).","[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Ahmadi', 'Affiliation': 'Klinik und Hochschulambulanz für Neurologie, Campus Benjamin Franklin, Charité Universitätsmedizin Berlin, Berlin, Germany; Berlin Institute of Health, Berlin, Germany.'}, {'ForeName': 'Inga', 'Initials': 'I', 'LastName': 'Laumeier', 'Affiliation': 'Klinik und Hochschulambulanz für Neurologie, Campus Benjamin Franklin, Charité Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Ihl', 'Affiliation': 'Klinik und Hochschulambulanz für Neurologie, Campus Benjamin Franklin, Charité Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Maureen', 'Initials': 'M', 'LastName': 'Steinicke', 'Affiliation': 'Klinik und Hochschulambulanz für Neurologie, Campus Benjamin Franklin, Charité Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Ferse', 'Affiliation': 'Klinik und Hochschulambulanz für Neurologie, Campus Benjamin Franklin, Charité Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Endres', 'Affiliation': 'Klinik und Hochschulambulanz für Neurologie, Charité Universitätsmedizin Berlin, Berlin, Germany; Center for Stroke Research Berlin, Charité Universitätsmedizin Berlin, Berlin, Germany; Berlin Institute of Health, Berlin, Germany; German Centre for Cardiovascular Research, Berlin, Germany; German Center for Neurodegenerative Diseases, Berlin, Germany.'}, {'ForeName': 'Armin', 'Initials': 'A', 'LastName': 'Grau', 'Affiliation': 'Klinikum Ludwigshafen, Ludwigshafen, Germany.'}, {'ForeName': 'Sidsel', 'Initials': 'S', 'LastName': 'Hastrup', 'Affiliation': 'The Danish Stroke Centre, Neurology, University Hospital Aarhus, Aarhus, Denmark.'}, {'ForeName': 'Holger', 'Initials': 'H', 'LastName': 'Poppert', 'Affiliation': 'Klinikum Rechts der Isar, Technical University Munich, Munich, Germany.'}, {'ForeName': 'Frederick', 'Initials': 'F', 'LastName': 'Palm', 'Affiliation': 'Klinikum Ludwigshafen, Ludwigshafen, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Schoene', 'Affiliation': 'Klinik und Hochschulambulanz für Neurologie, Campus Benjamin Franklin, Charité Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Christian L', 'Initials': 'CL', 'LastName': 'Seifert', 'Affiliation': 'Klinikum Rechts der Isar, Technical University Munich, Munich, Germany.'}, {'ForeName': 'Farid I', 'Initials': 'FI', 'LastName': 'Kandil', 'Affiliation': 'Klinik und Hochschulambulanz für Neurologie, Campus Benjamin Franklin, Charité Universitätsmedizin Berlin, Berlin, Germany; Institute of Computational Neuroscience, University Medical Center Hamburg Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Joachim E', 'Initials': 'JE', 'LastName': 'Weber', 'Affiliation': 'Klinik und Hochschulambulanz für Neurologie, Campus Benjamin Franklin, Charité Universitätsmedizin Berlin, Berlin, Germany; Berlin Institute of Health, Berlin, Germany.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'von Weitzel-Mudersbach', 'Affiliation': 'The Danish Stroke Centre, Neurology, University Hospital Aarhus, Aarhus, Denmark.'}, {'ForeName': 'Martin L J', 'Initials': 'MLJ', 'LastName': 'Wimmer', 'Affiliation': 'Praxis für Neurologie und Psychiatrie am Prinzregentenplatz, Munich, Germany.'}, {'ForeName': 'Ale', 'Initials': 'A', 'LastName': 'Algra', 'Affiliation': 'Department of Neurology and Neurosurgery and Julius Center, University Medical Center Utrecht and Utrecht University, Utrecht, Netherlands.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Amarenco', 'Affiliation': 'Department of Neurology and Stroke Centre, Bichat Hospital, Université Paris Diderot, Paris, France.'}, {'ForeName': 'Jacoba P', 'Initials': 'JP', 'LastName': 'Greving', 'Affiliation': 'Department of Neurology and Neurosurgery and Julius Center, University Medical Center Utrecht and Utrecht University, Utrecht, Netherlands.'}, {'ForeName': 'Otto', 'Initials': 'O', 'LastName': 'Busse', 'Affiliation': 'German Stroke Society, Berlin, Germany.'}, {'ForeName': 'Friedrich', 'Initials': 'F', 'LastName': 'Köhler', 'Affiliation': 'Medical Department, Division of Cardiology and Angiology, Campus Charité Mitte, Centre for Cardiovascular Telemedicine, Charité Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Marx', 'Affiliation': 'Klinik und Hochschulambulanz für Neurologie, Campus Benjamin Franklin, Charité Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Heinrich J', 'Initials': 'HJ', 'LastName': 'Audebert', 'Affiliation': 'Klinik und Hochschulambulanz für Neurologie, Campus Benjamin Franklin, Charité Universitätsmedizin Berlin, Berlin, Germany; Center for Stroke Research Berlin, Charité Universitätsmedizin Berlin, Berlin, Germany. Electronic address: Heinrich.audebert@charite.de.'}]",The Lancet. Neurology,['10.1016/S1474-4422(19)30369-2'] 1140,30902750,Effects of liraglutide plus phentermine in adults with obesity following 1 year of treatment by liraglutide alone: A randomized placebo-controlled pilot trial.,"BACKGROUND This pilot study evaluated whether adding phentermine to liraglutide would induce further weight loss in participants who had previously lost weight with liraglutide alone. SUBJECTS/METHODS Participants were 45 adults with obesity (75.6% female, 55.6% white, body mass index = 34.3 ± 4.7 kg/m 2 ) who had lost an average of 12.6 ± 6.8% of initial weight during a prior 1-year randomized trial with liraglutide and intensive behavioral treatment. Participants were re-randomized, in a double-blinded fashion, to liraglutide 3.0 mg plus phentermine 15.0 mg (liraglutide-phentermine) or liraglutide plus placebo (liraglutide-placebo). Participants also were provided with four, 15-minute counseling sessions during the 12-week extension study. RESULTS At week 12, the liraglutide-phentermine and liraglutide-placebo groups lost a mean (±SEM) of 1.6 ± 0.6% and 0.1 ± 0.5% of re-randomization weight, respectively (p = 0.073). Two (9.1%) liraglutide-phentermine participants and one (4.3%) liraglutide-placebo participant lost ≥5% of re-randomization weight; 19 (86.4%) and 16 (69.9%) participants, respectively, maintained their full weight loss achieved in the prior 1-year trial (p = 0.125). Liraglutide-phentermine participants generally reported larger reductions in hunger and food preoccupation than liraglutide-placebo participants during the first 8 weeks of the extension study. CONCLUSIONS The combination of liraglutide and phentermine appeared to be well-tolerated but did not produce additional clinically meaningful weight loss in individuals who had already lost 12.6% of initial weight with liraglutide alone. TRIAL REGISTRATION ClinicalTrials.gov number, NCT02911818.",2019,"Liraglutide-phentermine participants generally reported larger reductions in hunger and food preoccupation than liraglutide-placebo participants during the first 8 weeks of the extension study. ","['individuals who had already lost 12.6% of initial weight with liraglutide alone', 'participants who had previously lost weight with liraglutide alone', 'Participants were 45 adults with obesity (75.6% female, 55.6% white, body mass index\u202f=\u202f34.3\u202f±\u202f4.7\u202fkg/m 2 ) who had lost an average of 12.6\u202f±\u202f6.8% of initial weight during a prior 1-year randomized trial with', 'adults with obesity following 1\u202fyear of treatment by liraglutide alone']","['liraglutide-placebo', 'liraglutide-phentermine', 'liraglutide plus phentermine', 'placebo', 'liraglutide-phentermine and liraglutide-placebo', 'liraglutide 3.0\u202fmg plus phentermine 15.0\u202fmg (liraglutide-phentermine) or liraglutide plus placebo (liraglutide-placebo', 'liraglutide', 'Liraglutide-phentermine', 'liraglutide and intensive behavioral treatment']","['meaningful weight loss', 'full weight loss', 'weight loss', 'hunger and food preoccupation']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C4517545', 'cui_str': 'Twelve point six'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0031447', 'cui_str': 'Phentermine'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0020175', 'cui_str': 'Hunger'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0549165', 'cui_str': 'Preoccupation with ideas'}]",45.0,0.417909,"Liraglutide-phentermine participants generally reported larger reductions in hunger and food preoccupation than liraglutide-placebo participants during the first 8 weeks of the extension study. ","[{'ForeName': 'Jena Shaw', 'Initials': 'JS', 'LastName': 'Tronieri', 'Affiliation': 'Perelman School of Medicine at the University of Pennsylvania, Department of Psychiatry, Center for Weight and Eating Disorders, Philadelphia, PA, United States of America. Electronic address: jena.tronieri@pennmedicine.upenn.edu.'}, {'ForeName': 'Thomas A', 'Initials': 'TA', 'LastName': 'Wadden', 'Affiliation': 'Perelman School of Medicine at the University of Pennsylvania, Department of Psychiatry, Center for Weight and Eating Disorders, Philadelphia, PA, United States of America.'}, {'ForeName': 'Olivia A', 'Initials': 'OA', 'LastName': 'Walsh', 'Affiliation': 'Perelman School of Medicine at the University of Pennsylvania, Department of Psychiatry, Center for Weight and Eating Disorders, Philadelphia, PA, United States of America.'}, {'ForeName': 'Robert I', 'Initials': 'RI', 'LastName': 'Berkowitz', 'Affiliation': ""Perelman School of Medicine at the University of Pennsylvania, Department of Psychiatry, Center for Weight and Eating Disorders, Philadelphia, PA, United States of America; The Children's Hospital of Philadelphia, Department of Child and Adolescent Psychiatry, Philadelphia, PA, United States of America.""}, {'ForeName': 'Naji', 'Initials': 'N', 'LastName': 'Alamuddin', 'Affiliation': 'Perelman School of Medicine at the University of Pennsylvania, Department of Psychiatry, Center for Weight and Eating Disorders, Philadelphia, PA, United States of America; Perelman School of Medicine at the University of Pennsylvania, Department of Medicine, Philadelphia, PA, United States of America; Royal College of Surgeons in Ireland/Medical University of Bahrain/King Hamad University Hospital, Bahrain.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Gruber', 'Affiliation': 'Perelman School of Medicine at the University of Pennsylvania, Department of Psychiatry, Center for Weight and Eating Disorders, Philadelphia, PA, United States of America.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Leonard', 'Affiliation': 'Perelman School of Medicine at the University of Pennsylvania, Department of Psychiatry, Center for Weight and Eating Disorders, Philadelphia, PA, United States of America.'}, {'ForeName': 'Ariana M', 'Initials': 'AM', 'LastName': 'Chao', 'Affiliation': 'Perelman School of Medicine at the University of Pennsylvania, Department of Psychiatry, Center for Weight and Eating Disorders, Philadelphia, PA, United States of America; University of Pennsylvania School of Nursing, Department of Biobehavioral Health Sciences, Philadelphia, PA, United States of America.'}]",Metabolism: clinical and experimental,['10.1016/j.metabol.2019.03.005'] 1141,30893216,Short Versus Long InterTAN Fixation for Geriatric Intertrochanteric Hip Fractures: A Multicentre Head-to-Head Comparison.,"OBJECTIVE To determine if geriatric intertrochanteric hip fracture patients achieve equivalent postoperative functional status after management with either a short (180-200 mm) or a long (260-460 mm) InterTAN intramedullary device. DESIGN Retrospective review of a prospective randomized control trial. SETTING Four Level I Trauma Centers. PATIENTS/PARTICIPANTS One hundred eight patients with OTA/AO classification 31A-1 and 31A-2 intertrochanteric hip fractures were included in the study. INTERVENTION Internal fixation using an IT device. MAIN OUTCOMES MEASURES Primary outcomes included Functional Independence Measure and Timed Up and Go. Secondary outcomes included blood loss, surgical time, length of stay, adverse events, and mortality. RESULTS Seventy-one short and 37 long IT patients met study inclusion criteria. Demographics were similar between groups. There was no difference in Functional Independence Measure or Timed Up and Go scores between the 2 IT groups at any of the time points collected. Mean operative time was lower in the short IT group than in the long IT group (60 vs. 73 minutes; P = 0.021). A higher proportion of long IT patients had reamed constructs (95% vs. 48% short IT, P < 0.001). Postoperative blood loss was significantly higher in the long IT group without a significant influence on the number of patients requiring transfusion (P = 0.582) or average units transfused (P = 0.982). There was no significant difference in the proportion of postoperative adverse events between the 2 cohorts despite a higher number of peri-implant femur fractures in the short IT group than in the long IT group (5 vs. 1, P = 0.350). CONCLUSIONS Postoperative functional status was not influenced by the length of IT device in the management of geriatric intertrochanteric hip fractures. LEVEL OF EVIDENCE Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.",2019,There was no difference in Functional Independence Measure or Timed Up and Go scores between the 2 IT groups at any of the time points collected.,"['One hundred eight patients with OTA/AO classification 31A-1 and 31A-2 intertrochanteric hip fractures were included in the study', 'Seventy-one', 'Geriatric Intertrochanteric Hip Fractures', 'geriatric intertrochanteric hip fracture patients', 'Four Level']",['Short Versus Long InterTAN Fixation'],"['blood loss, surgical time, length of stay, adverse events, and mortality', 'proportion of postoperative adverse events', 'Postoperative blood loss', 'number of patients requiring transfusion', 'Functional Independence Measure and Timed Up and Go', 'Mean operative time', 'Functional Independence Measure or Timed Up and Go scores']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0008903', 'cui_str': 'taxonomy'}, {'cui': 'C0019557', 'cui_str': 'Hip Fractures'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0450389', 'cui_str': '71 (qualifier value)'}, {'cui': 'C0017469', 'cui_str': 'Geriatrics'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]","[{'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0185023', 'cui_str': 'pexy'}]","[{'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0032788', 'cui_str': 'Blood Loss, Postoperative'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0199960', 'cui_str': 'Transfusion - action (qualifier value)'}, {'cui': 'C0451172', 'cui_str': 'Functional independence measure (assessment scale)'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",108.0,0.0677838,There was no difference in Functional Independence Measure or Timed Up and Go scores between the 2 IT groups at any of the time points collected.,"[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Sellan', 'Affiliation': 'Department of Surgery, Western University, London, ON, Canada.'}, {'ForeName': 'Dianne', 'Initials': 'D', 'LastName': 'Bryant', 'Affiliation': 'Department of Surgery, Western University, London, ON, Canada.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Tieszer', 'Affiliation': 'Department of Surgery, Western University, London, ON, Canada.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Papp', 'Affiliation': 'University of Ottawa, Ottawa, ON, Canada.'}, {'ForeName': 'Abdel', 'Initials': 'A', 'LastName': 'Lawendy', 'Affiliation': 'Department of Surgery, Western University, London, ON, Canada.'}, {'ForeName': 'Allan', 'Initials': 'A', 'LastName': 'Liew', 'Affiliation': 'University of Ottawa, Ottawa, ON, Canada.'}, {'ForeName': 'Darius', 'Initials': 'D', 'LastName': 'Viskontas', 'Affiliation': 'University of British Columbia, New Westminister, BC, Canada.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'MacLeod', 'Affiliation': 'Department of Surgery, Western University, London, ON, Canada.'}, {'ForeName': 'Chad', 'Initials': 'C', 'LastName': 'Coles', 'Affiliation': 'Dalhousie University, Halifax, NS, Canada.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Carey', 'Affiliation': 'Department of Surgery, Western University, London, ON, Canada.'}, {'ForeName': 'Wade', 'Initials': 'W', 'LastName': 'Gofton', 'Affiliation': 'University of Ottawa, Ottawa, ON, Canada.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Trenholm', 'Affiliation': 'Dalhousie University, Halifax, NS, Canada.'}, {'ForeName': 'Trevor', 'Initials': 'T', 'LastName': 'Stone', 'Affiliation': 'University of British Columbia, New Westminister, BC, Canada.'}, {'ForeName': 'Ross', 'Initials': 'R', 'LastName': 'Leighton', 'Affiliation': 'Dalhousie University, Halifax, NS, Canada.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Sanders', 'Affiliation': 'Department of Surgery, Western University, London, ON, Canada.'}]",Journal of orthopaedic trauma,['10.1097/BOT.0000000000001409'] 1142,30893220,Ultrasound-Guided Nerve Blocks as Analgesia for Nonoperative Management of Distal Radius Fractures-Two Consecutive Randomized Controlled Trials.,"OBJECTIVES To investigate whether a conventional fracture hematoma block (FHB) or an ultrasound-guided peripheral nerve block has more superior analgesic effect during nonoperative management of distal radius fractures in an emergency department setting. Two peripheral nerve block types were investigated, one at the level of the elbow, or cubital nerve block (CNB), and another an axillary nerve block (ANB). DESIGN Two prospective randomized controlled studies were performed to compare the difference in pain intensity during closed reduction of a distal radius fracture between FHB-, CNB-, and, ANB-treated patients. SETTING Level 2 trauma center. PATIENTS One hundred ten patients with radiographic displaced distal radius fractures were randomized. Fifty patients were randomized between FHB and CNB, and 60 patients were randomized between CNB and ANB. INTERVENTION FHB, CNB, or ANB. These were performed by 3 physicians new to ultrasound-guided peripheral nerve blocks and trained before onset of this study. MAIN OUTCOME MEASUREMENT Pain was sequentially measured using an NRS during closed distal radius fracture reduction. RESULTS CNB patients experienced less pain during block procedure (P = 0.002), finger trap traction (P = 0.007), fracture reduction (P = 0.00001), after plaster cast application (P = 0.01), and after control radiography (P = 0.01). In our second study, ANB-treated patients reported less pain during block procedure (P = 0.04), during finger trap traction (P < 0.0001), fracture reduction (P < 0.0001), after plaster cast application (P = 0.0001), and after control radiography (P = 0.0005). CONCLUSIONS Although participating clinicians had minimal expertise using ultrasound-guided peripheral nerve blocks, nonoperative management of distal radius fracture using an ANB was less painful. These block types are expected to completely eradicate sensation the best. Future studies should address technical factors including adequate placement and time to let the block set up, as well as issues such as resource utilization including time and clinician availability to better determine the relative advantages and disadvantages to other analgesia techniques such as the FHB. LEVEL OF EVIDENCE Therapeutic Level II. See Instructions for Authors for a complete description of levels of evidence.",2019,"RESULTS CNB patients experienced less pain during block procedure (P = 0.002), finger trap traction (P = 0.007), fracture reduction (P = 0.00001), after plaster cast application (P = 0.01), and after control radiography (P = 0.01).","['Level 2 trauma center', 'Fifty patients were randomized between FHB and CNB, and 60 patients', 'Distal Radius Fractures', 'One hundred ten patients with radiographic displaced distal radius fractures']","['conventional fracture hematoma block (FHB) or an ultrasound-guided peripheral nerve block', 'Ultrasound-Guided Nerve Blocks as Analgesia']","['finger trap traction', 'pain', 'Pain', 'fracture reduction', 'pain intensity']","[{'cui': 'C0456948', 'cui_str': 'Level 2 (qualifier value)'}, {'cui': 'C0040786', 'cui_str': 'Trauma Centers'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0588207', 'cui_str': 'Bone structure of distal radius (body structure)'}, {'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}, {'cui': 'C0472452', 'cui_str': 'Fracture infiltration with local anesthetic (procedure)'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0198807', 'cui_str': 'Peripheral block anesthesia (procedure)'}, {'cui': 'C0027741', 'cui_str': 'Nerve Blockade'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}]","[{'cui': 'C0016129', 'cui_str': 'Fingers'}, {'cui': 'C0040597', 'cui_str': 'Traction'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1112432', 'cui_str': 'Reduction of fracture'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}]",110.0,0.0639076,"RESULTS CNB patients experienced less pain during block procedure (P = 0.002), finger trap traction (P = 0.007), fracture reduction (P = 0.00001), after plaster cast application (P = 0.01), and after control radiography (P = 0.01).","[{'ForeName': 'Michiel', 'Initials': 'M', 'LastName': 'Siebelt', 'Affiliation': 'Departments of Orthopedic Surgery.'}, {'ForeName': 'Klaas A', 'Initials': 'KA', 'LastName': 'Hartholt', 'Affiliation': 'General Surgery.'}, {'ForeName': 'Daniëlle F M', 'Initials': 'DFM', 'LastName': 'van Winden', 'Affiliation': 'Emergency Medicine, and.'}, {'ForeName': 'Femke', 'Initials': 'F', 'LastName': 'Boot', 'Affiliation': 'Emergency Medicine, and.'}, {'ForeName': 'Dafni', 'Initials': 'D', 'LastName': 'Papathanasiou', 'Affiliation': 'Emergency Medicine, and.'}, {'ForeName': 'Bas C', 'Initials': 'BC', 'LastName': 'Verdouw', 'Affiliation': 'Anaesthesiology, Reinier de Graaf Hospital, Delft, the Netherlands.'}, {'ForeName': 'Mark R', 'Initials': 'MR', 'LastName': 'de Vries', 'Affiliation': 'General Surgery.'}, {'ForeName': 'Nina M', 'Initials': 'NM', 'LastName': 'Mathijssen', 'Affiliation': 'Departments of Orthopedic Surgery.'}, {'ForeName': 'Gerald A', 'Initials': 'GA', 'LastName': 'Kraan', 'Affiliation': 'Departments of Orthopedic Surgery.'}]",Journal of orthopaedic trauma,['10.1097/BOT.0000000000001388'] 1143,30830964,"Validation of a HPLC/MS method for simultaneous quantification of clonidine, morphine and its metabolites in human plasma.","A high-performance liquid chromatography-tandem mass spectrometry method was developed and validated for the simultaneous quantification of morphine, morphine's major metabolites morphine-3-glucuronide and morphine-6-glucuronide, and clonidine, to support the pharmacokinetic analysis of an ongoing double-blinded randomized clinical trial that compares the use of morphine and clonidine in infants diagnosed with neonatal abstinence syndrome. Plasma samples were processed by solid-phase extraction and separated on an Inertsil ODS-3 (4 μm) column using an 0.1% formic acid in water-0.1% formic acid in methanol gradient. Detection of the analytes was conducted in the positive multiple reaction monitoring mode. The range of quantitation was 1-1000 ng/mL for morphine, morphine-3-glucuronide and morphine-6-glucuronide, and 0.25-100 ng/mL for clonidine. Intra-day and inter-day accuracy and precision were ≤15% for all analytes across the quantitation range. Extraction recovery rates were ≥94% for morphine, ≥90% for M3G, ≥87% for M6G and ≥ 79% for clonidine. Matrix effect ranged from 85-94% for clonidine to 101-106% for M3G. The method fulfilled all predetermined acceptance criteria and required only 100 μL of starting plasma volume. Furthermore, it was successfully applied to 30 clinical trial plasma samples.",2019,"The range of quantitation was 1-1000 ng/mL for morphine, morphine-3-glucuronide and morphine-6-glucuronide, and 0.25-100 ng/mL for clonidine.","['infants diagnosed with neonatal abstinence syndrome', 'human plasma']","['morphine', 'morphine and clonidine', 'clonidine', 'morphine, morphine-3-glucuronide and morphine-6-glucuronide', 'clonidine, morphine']","['Matrix effect', 'Extraction recovery rates']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0027609', 'cui_str': 'Neonatal Withdrawal Syndrome'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}]","[{'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0009014', 'cui_str': 'Clonidine'}, {'cui': 'C0066815', 'cui_str': 'morphine-3-glucuronide'}, {'cui': 'C0066816', 'cui_str': 'morphine-6beta-glucuronide'}]","[{'cui': 'C4319583', 'cui_str': 'Matrix'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0185115', 'cui_str': 'Extraction - action (qualifier value)'}]",,0.0768914,"The range of quantitation was 1-1000 ng/mL for morphine, morphine-3-glucuronide and morphine-6-glucuronide, and 0.25-100 ng/mL for clonidine.","[{'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Tang', 'Affiliation': 'Department of Pharmaceutical Sciences, University of Kentucky, Lexington, KY, USA.'}, {'ForeName': 'Henrietta', 'Initials': 'H', 'LastName': 'Bada', 'Affiliation': 'Department of Pediatrics, College of Medicine, University of Kentucky, Lexington, KY, USA.'}, {'ForeName': 'Chee M', 'Initials': 'CM', 'LastName': 'Ng', 'Affiliation': 'Department of Pharmaceutical Sciences, University of Kentucky, Lexington, KY, USA.'}, {'ForeName': 'Markos', 'Initials': 'M', 'LastName': 'Leggas', 'Affiliation': 'Department of Pharmaceutical Sciences, University of Kentucky, Lexington, KY, USA.'}]",Biomedical chromatography : BMC,['10.1002/bmc.4527'] 1144,30900195,A Virtual Resiliency Intervention for Parents of Children with Autism: A Randomized Pilot Trial.,"Parents of children with Autism experience high levels of stress. Resiliency is the ability to cope and adapt when faced with stressful events. This randomized, waitlist controlled pilot trial examines the feasibility, acceptability, and preliminary efficacy of an adapted virtual mind-body group intervention for parents of children with ASD. The intervention was feasible and acceptable. The immediate treatment group showed no difference in distress and greater improvement in resiliency and stress reactivity/coping relative to the delayed treatment group, (M difference 5.78; p = .038 and M difference 7.78; p = .001 respectively). Findings showed promising feasibility, acceptability, and preliminary efficacy for parents of children with ASD.",2020,"The immediate treatment group showed no difference in distress and greater improvement in resiliency and stress reactivity/coping relative to the delayed treatment group, (M difference 5.78; p = .038 and M difference 7.78; p = .001 respectively).","['parents of children with ASD', 'Parents of children with Autism experience high levels of stress', 'Parents of Children with Autism']","['adapted virtual mind-body group intervention', 'Virtual Resiliency Intervention']","['resiliency and stress reactivity/coping relative', 'distress']","[{'cui': 'C0030551', 'cui_str': 'Parent of (observable entity)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004352', 'cui_str': 'Autism, Early Infantile'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C1319127', 'cui_str': 'Level of stress'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}]",,0.0497679,"The immediate treatment group showed no difference in distress and greater improvement in resiliency and stress reactivity/coping relative to the delayed treatment group, (M difference 5.78; p = .038 and M difference 7.78; p = .001 respectively).","[{'ForeName': 'Karen A', 'Initials': 'KA', 'LastName': 'Kuhlthau', 'Affiliation': 'Department of Pediatrics, Massachusetts General Hospital, 125 Nashua Street Suite 860, Boston, MA, 02114, USA. kkuhlthau@mgh.harvard.edu.'}, {'ForeName': 'Christina M', 'Initials': 'CM', 'LastName': 'Luberto', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, 55 Fruit Street, Boston, MA, 02114, USA.'}, {'ForeName': 'Lara', 'Initials': 'L', 'LastName': 'Traeger', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, 55 Fruit Street, Boston, MA, 02114, USA.'}, {'ForeName': 'Rachel A', 'Initials': 'RA', 'LastName': 'Millstein', 'Affiliation': 'Benson-Henry Institute for Mind Body Medicine, Massachusetts General Hospital, 100 Cambridge Street, Boston, MA, 02114, USA.'}, {'ForeName': 'Giselle K', 'Initials': 'GK', 'LastName': 'Perez', 'Affiliation': 'Benson-Henry Institute for Mind Body Medicine, Massachusetts General Hospital, 100 Cambridge Street, Boston, MA, 02114, USA.'}, {'ForeName': 'Olivia J', 'Initials': 'OJ', 'LastName': 'Lindly', 'Affiliation': 'Department of Pediatrics, Massachusetts General Hospital, 125 Nashua Street Suite 860, Boston, MA, 02114, USA.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Chad-Friedman', 'Affiliation': 'Benson-Henry Institute for Mind Body Medicine, Massachusetts General Hospital, 100 Cambridge Street, Boston, MA, 02114, USA.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Proszynski', 'Affiliation': 'Benson-Henry Institute for Mind Body Medicine, Massachusetts General Hospital, 100 Cambridge Street, Boston, MA, 02114, USA.'}, {'ForeName': 'Elyse R', 'Initials': 'ER', 'LastName': 'Park', 'Affiliation': 'Benson-Henry Institute for Mind Body Medicine, Massachusetts General Hospital, 100 Cambridge Street, Boston, MA, 02114, USA.'}]",Journal of autism and developmental disorders,['10.1007/s10803-019-03976-4'] 1145,31828857,"The effect of Trigonella foenum-graecum extract on prostate-specific antigen, and prostate function in otherwise healthy men with benign prostate hyperplasia.","The aim of this trial was to evaluate the effect of a standardised Trigonella foenum-graecum (Fenugreek) extract on the symptoms of benign prostate hyperplasia (BPH) using a double-blind randomised placebo controlled design. The study recruited 100 healthy males aged between 45 and 80 years with symptoms of BPH who recorded a minimum score of eight on the International Prostate Symptom Score. Participants were randomised to an oral dose of either 600mg Trigonella foenum-graceum per day or placebo for 12 weeks. The primary outcome measure was the International Prostate Symptom Score total and subdomain scores. The secondary outcomes were serum levels of the hormones (testosterone, free testosterone, and sex hormone binding globulin) prostate-specific antigen, and safety markers. The results indicated that Trigonella foenum-graceum did not have an effect on improving the symptoms of BPH. Hormone levels, safety markers, and prostate-specific antigen remained unchanged and within normal limits after 12 weeks, which adds to the safety profile of this specialised extract.",2020,The results indicated that Trigonella foenum-graceum did not have an effect on improving the symptoms of BPH.,"['100 healthy males aged between 45 and 80 years with symptoms of BPH who recorded a minimum score of eight on the International Prostate Symptom Score', 'otherwise healthy men with benign prostate hyperplasia', 'benign prostate hyperplasia (BPH']","['placebo', 'Trigonella foenum-graecum extract', 'standardised Trigonella foenum-graecum (Fenugreek) extract', '600mg Trigonella foenum-graceum per day or placebo']","['International Prostate Symptom Score total and subdomain scores', 'serum levels of the hormones (testosterone, free testosterone, and sex hormone binding globulin) prostate-specific antigen, and safety markers', 'prostate-specific antigen, and prostate function', 'symptoms of BPH', 'Hormone levels, safety markers, and prostate-specific antigen']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0005001', 'cui_str': 'Benign enlargement of prostate'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1998280', 'cui_str': 'International prostate symptom score (assessment scale)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0205183', 'cui_str': 'Benign (qualifier value)'}, {'cui': 'C0033572', 'cui_str': 'Prostate'}, {'cui': 'C0020507', 'cui_str': 'Hyperplasia'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0060207', 'cui_str': 'Poenumgraecum'}, {'cui': 'C2752151', 'cui_str': 'Extract (qualifier value)'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0950072', 'cui_str': 'Trigonella'}, {'cui': 'C0439505', 'cui_str': 'per day'}]","[{'cui': 'C1998280', 'cui_str': 'International prostate symptom score (assessment scale)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0019932', 'cui_str': 'Hormones'}, {'cui': 'C0523912', 'cui_str': 'Testosterone measurement (procedure)'}, {'cui': 'C0443483', 'cui_str': 'Free testosterone (substance)'}, {'cui': 'C0202218', 'cui_str': 'Sex hormone binding globulin measurement (procedure)'}, {'cui': 'C0138741', 'cui_str': 'gamma-Seminoprotein'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0033572', 'cui_str': 'Prostate'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0005001', 'cui_str': 'Benign enlargement of prostate'}, {'cui': 'C1287355', 'cui_str': 'Finding of hormone level (finding)'}]",100.0,0.584036,The results indicated that Trigonella foenum-graceum did not have an effect on improving the symptoms of BPH.,"[{'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Rao', 'Affiliation': 'School of Medicine, The University of Sydney, Sydney, Australia.'}, {'ForeName': 'Ross', 'Initials': 'R', 'LastName': 'Grant', 'Affiliation': 'Department of Pharmacology, University of New South Wales, Sydney, Australia.'}]",Phytotherapy research : PTR,['10.1002/ptr.6554'] 1146,31409556,Colchicine as a Novel Therapy for Suppressing Chemokine Production in Patients With an Acute Coronary Syndrome: A Pilot Study.,"PURPOSE Existing literature reports that colchicine inhibits inflammasome activation and downstream inflammatory cytokine production and stabilizes coronary plaque. However, colchicine's effect on chemokines, which orchestrate multiple atheroinflammatory pathways, is unknown. METHODS Patients with acute coronary syndrome (ACS) were randomly assigned to colchicine (1.5 mg PO) (n = 12; mean age, 65.2 years) or no treatment (n = 13; mean age, 62.2 years). Blood samples were collected during cardiac catheterization within 24 hours of colchicine administration from the coronary sinus, aortic root, and right atrium. Patients with colchicine-naive stable angina (SAP) (n = 13; mean age, 66.8 years) were additionally sampled. Serum chemokine levels were analyzed with ELISA. In parallel, monocytes from healthy donors were isolated and subjected to colchicine treatment. FINDINGS Transcoronary (TC) levels of chemokine ligand 2 (CCL2) and C-X3-C motif chemokine ligand 1 (CX3CL1) were significantly elevated in patients with ACS versus patients with SAP (P < 0.01). TC chemokine ligand 5 (CCL5) levels were not significantly (P = 0.084) elevated in patients with ACS versus patients with SAP. Colchicine treatment markedly reduced TC levels of CCL2, CCL5, and CX3CL1 in patients with ACS (P < 0.05). In vitro colchicine suppressed CCL2 gene expression in stimulated monocytes (P < 0.05). Colchicine treatment reduced the intracellular concentration of all 3 chemokines (P < 0.01) and impaired monocyte chemotaxis (P < 0.05). IMPLICATIONS Here, we report for the first time that short-term colchicine therapy significantly reduces the local production of coronary chemokines, in part by attenuating production of these mediators by monocytes. These data provide further evidence of colchicine's beneficial role in patients with ACS.",2019,"Colchicine treatment reduced the intracellular concentration of all 3 chemokines (P < 0.01) and impaired monocyte chemotaxis (P < 0.05). ","['Patients with colchicine-naive stable angina (SAP) (n\xa0=\xa013; mean age, 66.8 years', 'mean age, 65.2 years) or no treatment (n\xa0=\xa013; mean age, 62.2 years', 'Patients With an Acute Coronary Syndrome', 'patients with ACS versus patients with SAP', 'patients with ACS versus patients with SAP (P', 'Patients with acute coronary syndrome (ACS', 'patients with ACS']","['colchicine', 'colchicine (1.5\xa0mg PO', 'Colchicine', 'colchicine therapy']","['TC levels of CCL2, CCL5, and CX3CL1', 'TC chemokine ligand 5 (CCL5) levels', 'Serum chemokine levels', 'monocyte chemotaxis', 'intracellular concentration of all 3 chemokines', 'local production of coronary chemokines', 'Transcoronary (TC) levels of chemokine ligand 2 (CCL2) and C-X3-C motif chemokine ligand 1 (CX3CL1', 'CCL2 gene expression']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0009262', 'cui_str': 'Colchicine'}, {'cui': 'C0340288', 'cui_str': 'Angina Pectoris, Stable'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517844', 'cui_str': '66.8'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0948089', 'cui_str': 'Acute Coronary Syndrome'}]","[{'cui': 'C0009262', 'cui_str': 'Colchicine'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0282554', 'cui_str': 'Cytokines, Chemotactic'}, {'cui': 'C0023688', 'cui_str': 'Ligands'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C1276855', 'cui_str': 'Monocyte chemotaxis, function (observable entity)'}, {'cui': 'C0178719', 'cui_str': 'Intracellular (qualifier value)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0033268'}, {'cui': 'C0017262', 'cui_str': 'Gene Expression'}]",,0.0202805,"Colchicine treatment reduced the intracellular concentration of all 3 chemokines (P < 0.01) and impaired monocyte chemotaxis (P < 0.05). ","[{'ForeName': 'Bradley', 'Initials': 'B', 'LastName': 'Tucker', 'Affiliation': 'Heart Research Institute, Newtown, New South Wales, Australia. Electronic address: Bradley.tucker@hri.org.au.'}, {'ForeName': 'Rahul', 'Initials': 'R', 'LastName': 'Kurup', 'Affiliation': 'Heart Research Institute, Newtown, New South Wales, Australia; Sydney Medical School, The University of Sydney, Camperdown, New South Wales, Australia; Department of Cardiology, Royal Prince Alfred Hospital, Camperdown, New South Wales, Australia.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Barraclough', 'Affiliation': 'Heart Research Institute, Newtown, New South Wales, Australia; Sydney Medical School, The University of Sydney, Camperdown, New South Wales, Australia; Department of Cardiology, Royal Prince Alfred Hospital, Camperdown, New South Wales, Australia.'}, {'ForeName': 'Rodney', 'Initials': 'R', 'LastName': 'Henriquez', 'Affiliation': 'Heart Research Institute, Newtown, New South Wales, Australia.'}, {'ForeName': 'Siân', 'Initials': 'S', 'LastName': 'Cartland', 'Affiliation': 'Heart Research Institute, Newtown, New South Wales, Australia.'}, {'ForeName': 'Clare', 'Initials': 'C', 'LastName': 'Arnott', 'Affiliation': 'Heart Research Institute, Newtown, New South Wales, Australia; Sydney Medical School, The University of Sydney, Camperdown, New South Wales, Australia; Department of Cardiology, Royal Prince Alfred Hospital, Camperdown, New South Wales, Australia.'}, {'ForeName': 'Ashish', 'Initials': 'A', 'LastName': 'Misra', 'Affiliation': 'Heart Research Institute, Newtown, New South Wales, Australia.'}, {'ForeName': 'Gonzalo', 'Initials': 'G', 'LastName': 'Martínez', 'Affiliation': 'Heart Research Institute, Newtown, New South Wales, Australia; Division of Cardiovascular Diseases, Pontificia Universidad Católica de Chile, Santiago, Chile.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Kavurma', 'Affiliation': 'Heart Research Institute, Newtown, New South Wales, Australia; Sydney Medical School, The University of Sydney, Camperdown, New South Wales, Australia.'}, {'ForeName': 'Sanjay', 'Initials': 'S', 'LastName': 'Patel', 'Affiliation': 'Heart Research Institute, Newtown, New South Wales, Australia; Sydney Medical School, The University of Sydney, Camperdown, New South Wales, Australia; Department of Cardiology, Royal Prince Alfred Hospital, Camperdown, New South Wales, Australia.'}]",Clinical therapeutics,['10.1016/j.clinthera.2019.07.015'] 1147,30836013,Depression-related stigma: comparing laypersons' stigmatic attributions towards younger and older persons.,"Objectives: A great amount of interest has been invested in the understanding of public stigma toward persons with depression. However, published studies were mostly restricted to the study of stigma toward a young person with depression. This study was aimed to compare public stigma towards a younger and an older person with depression among a sample of the Jewish adult population in Israel. Method: Computerized phone interviews were conducted with 393 participants (aged 18+) who were randomly presented with one of two vignettes describing a younger or an older person with depression. Results: Overall, the participants reported low levels of stigma towards a person with depression. With the exception of pity, the younger person elicited higher levels of stigmatic attributions in all dimensions (cognitive, emotional, and behavioral) in comparison to the older person. Regardless of the age of the person with depression, only emotional reactions - but not cognitive attributions-were associated with discriminatory attributions. Conclusion: Our findings stress the importance of paying attention to the age of the person with depression in anti-stigma campaigns and studies to better understand the meaning and consequences of depression-stigma.",2020,"With the exception of pity, the younger person elicited higher levels of stigmatic attributions in all dimensions (cognitive, emotional, and behavioral) in comparison to the older person.","['public stigma towards a younger and an older person with depression among a sample of the Jewish adult population in Israel', 'persons with depression', 'younger and older persons', '393 participants (aged 18+) who were randomly presented with one of two vignettes describing a younger or an older person with depression']",[],"['Depression-related stigma', 'stigmatic attributions']","[{'cui': 'C0277787', 'cui_str': 'Stigma (finding)'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0178443', 'cui_str': 'Jewish, follower of religion (person)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0022271', 'cui_str': 'Israel'}, {'cui': 'C4517754', 'cui_str': 'Three hundred and ninety-three'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}]",[],"[{'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0277787', 'cui_str': 'Stigma (finding)'}]",393.0,0.0508273,"With the exception of pity, the younger person elicited higher levels of stigmatic attributions in all dimensions (cognitive, emotional, and behavioral) in comparison to the older person.","[{'ForeName': 'Perla', 'Initials': 'P', 'LastName': 'Werner', 'Affiliation': 'Department of Community Mental Health, University of Haifa, Haifa, Israel.'}, {'ForeName': 'Dikla', 'Initials': 'D', 'LastName': 'Segel-Karpas', 'Affiliation': 'Department of Gerontology, University of Haifa, Haifa, Israel.'}]",Aging & mental health,['10.1080/13607863.2019.1584791'] 1148,25808921,Reliable change in neuropsychological assessment of breast cancer survivors.,"BACKGROUND The purpose of this study was to enhance the current understanding and interpretation of longitudinal change on tests of neurocognitive function in individuals with cancer. Scores on standard neuropsychological instruments may be impacted by practice effects and other random forms of error. METHODS The current study assessed the test-retest reliability of several tests and overarching cognitive domains comprising a neurocognitive battery typical of those used for research and clinical evaluation using relevant time frames. Practice effect-adjusted reliable change confidence intervals for test-retest difference scores based on a sample of patient-matched healthy controls are provided. RESULTS By applying reliable change confidence intervals to scores from two samples of breast cancer patients at post-treatment follow-up assessment, meaningful levels of detectable change in cognitive functioning in breast cancer survivors were ascertained and indicate that standardized neuropsychological instruments may be subject to limitations in detection of subtle cognitive dysfunction over clinically relevant intervals, especially in patient samples with average to above average range baseline functioning. CONCLUSIONS These results are discussed in relation to reported prevalence of cognitive change in breast cancer patients along with recommendations for study designs that enhance detection of treatment effects.",2016,"RESULTS By applying reliable change confidence intervals to scores from two samples of breast cancer patients at post-treatment follow-up assessment,","['breast cancer patients', 'individuals with cancer', 'breast cancer survivors']",[],[],"[{'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}]",[],[],,0.0597246,"RESULTS By applying reliable change confidence intervals to scores from two samples of breast cancer patients at post-treatment follow-up assessment,","[{'ForeName': 'Charissa', 'Initials': 'C', 'LastName': 'Andreotti', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Memorial Sloan-Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'James C', 'Initials': 'JC', 'LastName': 'Root', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Memorial Sloan-Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Sanne B', 'Initials': 'SB', 'LastName': 'Schagen', 'Affiliation': 'Department of Psychosocial Research and Epidemiology, Netherlands Cancer Institute-Antoni van Leeuwenhoek Hospital, Amsterdam, The Netherlands.'}, {'ForeName': 'Brenna C', 'Initials': 'BC', 'LastName': 'McDonald', 'Affiliation': 'Indiana University Melvin and Bren Simon Cancer Center, Indiana University School of Medicine, Indianapolis, IN, USA.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Saykin', 'Affiliation': 'Indiana University Melvin and Bren Simon Cancer Center, Indiana University School of Medicine, Indianapolis, IN, USA.'}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Atkinson', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Memorial Sloan-Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Yuelin', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Memorial Sloan-Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Tim A', 'Initials': 'TA', 'LastName': 'Ahles', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Memorial Sloan-Kettering Cancer Center, New York, NY, USA.'}]",Psycho-oncology,['10.1002/pon.3799'] 1149,31520460,"Safety and efficacy of coblopasvir and sofosbuvir in patients with genotypes 1, 2, 3 and 6 HCV infections without or with compensated cirrhosis.","A simple, pangenotypic and effective treatment regimen for patients with a broad range of chronic hepatitis C virus (HCV) infections remains an unmet medical need. We conducted a phase 2, randomized, open study involving untreated patients with chronic HCV genotypes 1, 2, 3, or 6 infections. Patients without cirrhosis were randomly assigned in a 1:2 ratio to receive capsules of the NS5A inhibitor coblopasvir at a dose of 30 or 60 mg plus tablets of the nucleotide polymerase inhibitor sofosbuvir (400 mg) once daily for 12 weeks. Patients with cirrhosis received 60 mg coblopasvir plus sofosbuvir for 12 weeks. The primary endpoint was the sustained virologic response at 12 weeks after the end of therapy (SVR12). Of the 110 patients who were enrolled in the study, 59 were male, 62.7% had HCV genotype 1, 24.5% had genotype 2, 6.4% had genotype 3, and 6.4% had genotype 6. The average age was 45.5 years. A total of 10.9% of patients had compensated cirrhosis. The rate of SVR12 was 98.2% in the intention-to-treat (ITT). One genotype 6 patient with cirrhosis experienced virologic relapse. One genotype 2 patient without cirrhosis failed to complete the follow-up and quit the study. Serious adverse events (SAEs) were reported in 2 patients and were not related to coblopasvir and sofosbuvir. Most adverse events (AEs) did not require treatment. Coblopasvir plus sofosbuvir taken once daily for 12 weeks provided high rates of sustained virologic response (SVR) and had a good safety profile among patients with HCV genotypes 1, 2, 3, or 6 infections, including those with compensated cirrhosis.",2020,Serious adverse events (SAEs) were reported in 2 patients and were not related to coblopasvir and sofosbuvir.,"['patients with a broad range of chronic hepatitis C virus (HCV) infections', 'Patients with cirrhosis received 60\xa0mg coblopasvir plus sofosbuvir for 12\xa0weeks', 'untreated patients with chronic HCV genotypes 1, 2, 3, or 6 infections', 'Patients without cirrhosis', '110 patients who were enrolled in the study, 59 were male, 62.7% had HCV genotype 1, 24.5% had genotype 2, 6.4% had genotype 3, and 6.4% had genotype 6', 'patients with genotypes 1, 2, 3 and 6 HCV infections without or with compensated cirrhosis']","['coblopasvir and sofosbuvir', 'NS5A inhibitor coblopasvir at a dose of 30 or 60\xa0mg plus tablets of the nucleotide polymerase inhibitor sofosbuvir']","['virologic relapse', 'sustained virologic response', 'Safety and efficacy', 'rate of SVR12', 'rates of sustained virologic response (SVR', 'Serious adverse events (SAEs']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0524910', 'cui_str': 'Hepatitis C, Chronic'}, {'cui': 'C0042769', 'cui_str': 'Viral Infections'}, {'cui': 'C1623038', 'cui_str': 'Cirrhosis'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C2976303', 'cui_str': 'sofosbuvir'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C1285573', 'cui_str': 'Genotype determination'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C4517536', 'cui_str': '110 (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C4517822', 'cui_str': '6.4 (qualifier value)'}, {'cui': 'C0205432', 'cui_str': 'Compensated (qualifier value)'}]","[{'cui': 'C2976303', 'cui_str': 'sofosbuvir'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}, {'cui': 'C0028630', 'cui_str': 'Nucleotides'}]","[{'cui': 'C0205466', 'cui_str': 'virology'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",59.0,0.0608174,Serious adverse events (SAEs) were reported in 2 patients and were not related to coblopasvir and sofosbuvir.,"[{'ForeName': 'Huiying', 'Initials': 'H', 'LastName': 'Rao', 'Affiliation': ""Beijing Key Laboratory for Hepatitis C and Immunotherapy for Liver Disease, Peking University People's Hospital, Peking University Hepatology Institute, Beijing, China.""}, {'ForeName': 'Guangjun', 'Initials': 'G', 'LastName': 'Song', 'Affiliation': ""Hepatology Department, Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Guangming', 'Initials': 'G', 'LastName': 'Li', 'Affiliation': ""Zhengzhou Municipal Sixth People's Hospital, Zhengzhou, China.""}, {'ForeName': 'Yongfeng', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Nanjing Municipal Second Hospital, Nanjing, China.'}, {'ForeName': 'Xiaofeng', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': ""Shenyang Municipal Sixth People's Hospital, Shenyang, China.""}, {'ForeName': 'Yujuan', 'Initials': 'Y', 'LastName': 'Guan', 'Affiliation': ""Guangzhou Municipal Eighth People's Hospital, Guanzhou, China.""}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Mao', 'Affiliation': 'Chinese PLA Third Military Medical University First Affiliated Hospital, Chongqing, China.'}, {'ForeName': 'Xiangjun', 'Initials': 'X', 'LastName': 'Jiang', 'Affiliation': 'Qingdao Municipal Hospital, Qingdao, China.'}, {'ForeName': 'Changyuan', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': ""Ji'nan Municipal Hospital of Infectious Disease, Ji'nan, Shandong, China.""}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': ""Dalian Municipal Sixth People's Hospital, Dalian, China.""}, {'ForeName': 'Jidong', 'Initials': 'J', 'LastName': 'Jia', 'Affiliation': 'Capital Medical University Affiliated Beijing Friendship Hospital, Beijing, China.'}, {'ForeName': 'Xiaolin', 'Initials': 'X', 'LastName': 'Guo', 'Affiliation': 'Jilin University First Hospital, Changchun, China.'}, {'ForeName': 'Chenghao', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'Yanbian University Affiliated Hospital, Yanji, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Ning', 'Affiliation': 'Beijing Kawin Technology Share-holding Co., Ltd., Beijing, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Qin', 'Affiliation': 'Beijing Kawin Technology Share-holding Co., Ltd., Beijing, China.'}, {'ForeName': 'Hai', 'Initials': 'H', 'LastName': 'Pan', 'Affiliation': 'Beijing Kawin Technology Share-holding Co., Ltd., Beijing, China.'}, {'ForeName': 'Lai', 'Initials': 'L', 'LastName': 'Wei', 'Affiliation': 'Hepatopancreatobiliary Center, Beijing Tsinghua Changgung Hospital, Tsinghua University, Beijing, China.'}]",Journal of viral hepatitis,['10.1111/jvh.13208'] 1150,30835640,Creation of a Rudimentary Electronic Pediatric Intensive Care Unit Model to Explore Resident-Attending Communication.,"Background: At-home attending intensivists often must return to the hospital to assist residents. Introduction: To determine if using telemedicine communication between in-house pediatric residents and at-home attending intensivists impacts the rate of attending return to the hospital and improves resident education. Methods: In this single-center prospective study at an academic children's hospital's pediatric intensive care unit (PICU), 40 patients younger than 18 years were randomized into video or telephone arms. Residents and intensivists completed anonymous surveys after each encounter. Video-conferencing encounters between residents and at-home, on-call intensivists were compared with standard telephone calls for admissions to PICU. Results: Video and telephone arms had 21 and 19 patients enrolled, respectively. Data comparison was performed using Mann-Whitney U, chi-square, and Kruskal-Wallis analysis. Clinical illness severity rating for intensivists and residents was not significantly different for video communication compared with telephone (p = 0.63 and p = 0.42, respectively). Intensivists reported no significant difference in ease of use (p = 0.87). There was perceived improvement in resident education with the use of telemedicine (52.6% vs. 76.2%; p = 0.11). Discussion: Video communication was easy to use but did not change the rating of illness severity or need for intensivist to return to the hospital. There was perceived improvement in resident education with the use of telemedicine, and it may serve as a useful tool in demonstrating acute clinical changes to out-of-hospital intensivists. Conclusions: Larger-scale studies in teaching hospitals with out-of-hospital pediatric intensivists need to be conducted to further evaluate the role of telemedicine in patient management and resident education.",2020,"Clinical illness severity rating for intensivists and residents was not significantly different for video communication compared with telephone (p = 0.63 and p = 0.42, respectively).","[""academic children's hospital's pediatric intensive care unit (PICU), 40 patients younger than 18 years""]",['video or telephone'],['Clinical illness severity rating'],"[{'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0021710', 'cui_str': 'PICU - Pediatric intensive care unit'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0221423', 'cui_str': 'Illness (finding)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}]",40.0,0.0573167,"Clinical illness severity rating for intensivists and residents was not significantly different for video communication compared with telephone (p = 0.63 and p = 0.42, respectively).","[{'ForeName': 'Nisha', 'Initials': 'N', 'LastName': 'Agasthya', 'Affiliation': 'Division of Pediatric Critical Care, Department of Pediatrics and Critical Care, Nemours/Alfred I. duPont Hospital for Children, Wilmington, Delaware.'}, {'ForeName': 'Katrina', 'Initials': 'K', 'LastName': 'Foo', 'Affiliation': 'Division of Pediatric Critical Care, Department of Pediatrics and Critical Care, Nemours/Alfred I. duPont Hospital for Children, Wilmington, Delaware.'}, {'ForeName': 'Tara', 'Initials': 'T', 'LastName': 'Smith', 'Affiliation': 'Division of Pediatric Critical Care, Department of Pediatrics, Cooper University Hospital, Camden, New Jersey.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Slamon', 'Affiliation': 'Division of Pediatric Critical Care, Department of Pediatrics and Critical Care, Nemours/Alfred I. duPont Hospital for Children, Wilmington, Delaware.'}]",Telemedicine journal and e-health : the official journal of the American Telemedicine Association,['10.1089/tmj.2018.0190'] 1151,30878219,Short term effect of yoga asana - An adjunct therapy to conventional treatment in frozen shoulder.,"BACKGROUND The available treatments for frozen shoulder yield variable results. Physical therapy and analgesics are considered as the first-line treatment for this disorder, but the effects are not uniform. There is some evidence to support that alternative medicine may have a role in its management. OBJECTIVE(S) This study was designed to examine the short-term effects of yoga therapy in patients with frozen shoulder of mild to moderate severity. MATERIALS AND METHODS A prospective randomized controlled trial was conducted on patients with frozen shoulder between 30 and 60 years of age. They were divided into two groups: yoga (Y) and control (NY). A set of Asana exercises called ""Standing Group of Asana"" was practiced by the yoga group in addition to the conventional therapy as received by the control group. The patients were reviewed at 1, 2 and 4 weeks. The pain and functional assessment were done at baseline and at each review using the Shoulder Pain and Disability Index (SPADI). RESULTS There were 16 male and 20 female participants in the Y group, and 15 males and 21 females in the NY group. There was no statistically significant difference in age, sex, and pre-treatment SPADI score between the groups. At the end of the four weeks, the SPADI pain scores in the Y and NY group were 20.47 and 20.14, respectively (p = 0.666). The SPADI disability scores in the Y and NY group were 20.4 and 19.7, respectively (p = 0.599). Overall SPADI scores were 40.67 and 40.03 in the Y and NY group, respectively (p = 0.736). Both groups had a significant reduction in SPADI pain and disability scores. However, there was no significant difference between the groups in terms of SPADI scores. CONCLUSION The effect of the Standing Group of Asana has no added advantage relative to standard frozen shoulder treatment when practiced for one month.",2020,"Overall SPADI scores were 40.67 and 40.03 in the Y and NY group, respectively (p = 0.736).","['patients with frozen shoulder of mild to moderate severity', '16 male and 20 female participants in the Y group, and 15 males and 21 females in the NY group', 'frozen shoulder', 'patients with frozen shoulder between 30 and 60 years of age']","['yoga asana - An adjunct therapy', 'Asana exercises called ""Standing Group of Asana', 'yoga therapy']","['SPADI pain and disability scores', 'SPADI scores', 'Shoulder Pain and Disability Index (SPADI', 'age, sex, and pre-treatment SPADI score', 'pain and functional assessment', 'SPADI disability scores', 'SPADI pain scores', 'Overall SPADI scores']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0311223', 'cui_str': 'Shoulder Adhesive Capsulitis'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C3888057', 'cui_str': 'Stand'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0037011', 'cui_str': 'Shoulder Pain'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",16.0,0.0264748,"Overall SPADI scores were 40.67 and 40.03 in the Y and NY group, respectively (p = 0.736).","[{'ForeName': 'Mantu', 'Initials': 'M', 'LastName': 'Jain', 'Affiliation': 'Department of Orthopedics, AIIMS, Bhubaneswar, 751019, India. Electronic address: montu_jn@yahoo.com.'}, {'ForeName': 'Prabhas Ranjan', 'Initials': 'PR', 'LastName': 'Tripathy', 'Affiliation': 'Department of Anatomy & in Charge AYUSH, AIIMS, Bhubaneswar, 751019, India.'}, {'ForeName': 'Rajesh', 'Initials': 'R', 'LastName': 'Manik', 'Affiliation': 'Yoga Instructor, Department of AYUSH, AIIMS, Bhubaneswar, 751019, India.'}, {'ForeName': 'Sujit', 'Initials': 'S', 'LastName': 'Tripathy', 'Affiliation': 'Department of Orthopedics, AIIMS, Bhubaneswar, 751019, India.'}, {'ForeName': 'Binod', 'Initials': 'B', 'LastName': 'Behera', 'Affiliation': 'Department of Community Medicine, AIIMS, Bhubaneswar, 751019, India.'}, {'ForeName': 'Apurba', 'Initials': 'A', 'LastName': 'Barman', 'Affiliation': 'Department of Physical Medicine & Rehabilitation, AIIMS, Bhubaneswar, 751019, India.'}]",Journal of Ayurveda and integrative medicine,['10.1016/j.jaim.2018.12.007'] 1152,30852167,Nursing Home Characteristics Associated With Implementation of an Advance Care Planning Video Intervention.,"OBJECTIVES Advance care planning (ACP) is important to ensure that nursing home (NH) residents receive care concordant with their goals. Video interventions have been developed to improve the process of ACP. Yet, little is known about which NH characteristics are associated with implementation of ACP video interventions in clinical practice. Our objective was to examine NH-level characteristics associated with the implementation of an ACP video intervention as part of the Pragmatic trial of Video Education in Nursing Homes (PROVEN) trial. DESIGN Cross-sectional study of NHs in PROVEN. SETTING AND PARTICIPANTS 119 NHs randomized to receive the ACP video intervention. MEASUREMENTS The outcomes were the proportion of short- (<100 days) and long-stay (≥100 days) NH residents who were (1) offered to watch a video and (2) shown a video, aggregated to the NH-level, and measured using electronic forms of video offers. The association between outcomes and NH facility characteristics (eg, staffing, resident acuity) and participation in other aspects of the PROVEN trial (eg, monthly check-in calls) were estimated using multivariate linear regression models. NH characteristics were measured using data from Online Survey Certification and Reporting data, Long-term Care: Facts on Care in the US and NH Compare. RESULTS Offer rates were 69% [standard deviation (SD): 28] for short-stay and 56% (SD: 20) for long-stay residents. Show rates were 19% (SD: 21) for short-stay and 17% (SD: 17) for long-stay residents. After adjusting for NH characteristics, compared to 1-star NHs, higher star-rated NHs had higher offer rates. Champions' participation in check-in calls was positively associated with both outcomes for long-stay residents. CONCLUSIONS/IMPLICATIONS Lower-quality NHs seem unable to integrate a novel ACP video education program into routine care processes. Ongoing support for and engagement with NH staff to champion the intervention throughout implementation is important for the success of a pragmatic trial within NHs.",2019,Show rates were 19% (SD: 21) for short-stay and 17% (SD: 17) for long-stay residents.,['Nursing Homes (PROVEN) trial'],"['ACP video intervention', 'Video interventions', 'Advance care planning (ACP']",['proportion of short- (<100\xa0days) and long-stay'],"[{'cui': 'C0028688', 'cui_str': 'Nursing Homes'}]","[{'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0600371', 'cui_str': 'Advance Health Care Planning'}]","[{'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}]",119.0,0.0703926,Show rates were 19% (SD: 21) for short-stay and 17% (SD: 17) for long-stay residents.,"[{'ForeName': 'Lacey', 'Initials': 'L', 'LastName': 'Loomer', 'Affiliation': 'Department of Health Services, Policy and Practice, School of Public Health, Brown University, Providence, RI. Electronic address: lacey_loomer@brown.edu.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'McCreedy', 'Affiliation': 'Center for Gerontology and Healthcare Research, School of Public Health, Brown University, Providence, RI.'}, {'ForeName': 'Emmanuelle', 'Initials': 'E', 'LastName': 'Belanger', 'Affiliation': 'Department of Health Services, Policy and Practice, School of Public Health, Brown University, Providence, RI.'}, {'ForeName': 'Jennifer A', 'Initials': 'JA', 'LastName': 'Palmer', 'Affiliation': 'Hebrew Senior Life, Institute for Aging Research, Boston, MA; Department of Medicine, Beth Israel Deaconess Medical Center, Boston, MA.'}, {'ForeName': 'Susan L', 'Initials': 'SL', 'LastName': 'Mitchell', 'Affiliation': 'Hebrew Senior Life, Institute for Aging Research, Boston, MA; Department of Medicine, Beth Israel Deaconess Medical Center, Boston, MA.'}, {'ForeName': 'Angelo E', 'Initials': 'AE', 'LastName': 'Volandes', 'Affiliation': 'Section of General Medicine, Massachusetts General Hospital, Boston, MA.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Mor', 'Affiliation': 'Department of Health Services, Policy and Practice, School of Public Health, Brown University, Providence, RI; Center for Gerontology and Healthcare Research, School of Public Health, Brown University, Providence, RI; Center of Innovation in HSR&D, Providence Veterans Administration Medical Center, Providence, RI.'}]",Journal of the American Medical Directors Association,['10.1016/j.jamda.2019.01.133'] 1153,30661255,The Nonsteroidal Farnesoid X Receptor Agonist Cilofexor (GS-9674) Improves Markers of Cholestasis and Liver Injury in Patients With Primary Sclerosing Cholangitis.,"Primary sclerosing cholangitis (PSC) represents a major unmet medical need. In a phase II double-blind, placebo-controlled study, we tested the safety and efficacy of cilofexor (formerly GS-9674), a nonsteroidal farnesoid X receptor agonist in patients without cirrhosis with large-duct PSC. Patients were randomized to receive cilofexor 100 mg (n = 22), 30 mg (n = 20), or placebo (n = 10) orally once daily for 12 weeks. All patients had serum alkaline phosphatase (ALP) > 1.67 × upper limit of normal and total bilirubin ≤ 2 mg/dL at baseline. Safety, tolerability, pharmacodynamic effects of cilofexor (serum C4 [7α-hydroxy-4-cholesten-3-one] and bile acids), and changes in liver biochemistry and serum fibrosis markers were evaluated. Overall, 52 patients were randomized (median age 43 years, 58% male, 60% with inflammatory bowel disease, 46% on ursodeoxycholic acid). Baseline median serum ALP and bilirubin were 348 U/L (interquartile range 288-439) and 0.7 mg/dL (0.5-1.0), respectively. Dose-dependent reductions in liver biochemistry were observed. At week 12, cilofexor 100 mg led to significant reductions in serum ALP (median reduction -21%; P = 0.029 versus placebo), gamma-glutamyl transferase (-30%; P < 0.001), alanine aminotransferase (ALT) (-49%; P = 0.009), and aspartate aminotransferase (-42%; P = 0.019). Cilofexor reduced serum C4 compared with placebo; reductions in bile acids were greatest with 100 mg. Relative reductions in ALP were similar between ursodeoxycholic acid-treated and untreated patients. At week 12, cilofexor-treated patients with a 25% or more relative reduction in ALP had greater reductions in serum alanine aminotransferase, aspartate aminotransferase, gamma-glutamyl transferase, tissue inhibitor of metalloproteinase 1, C-reactive protein, and bile acids than nonresponders. Adverse events were similar between cilofexor and placebo-treated patients. Rates of grade 2 or 3 pruritus were 14% with 100 mg, 20% with 30 mg, and 40% with placebo. Conclusion: In this 12-week, randomized, placebo-controlled study, cilofexor was well tolerated and led to significant improvements in liver biochemistries and markers of cholestasis in patients with PSC.",2019,All patients had serum alkaline phosphatase (ALP) > 1.67 × upper limit of normal and total bilirubin ≤ 2 mg/dL at baseline.,"['52 patients were randomized (median age 43 years, 58% male, 60% with inflammatory bowel disease, 46% on ursodeoxycholic acid', 'patients without cirrhosis with large-duct PSC', 'Patients With Primary Sclerosing Cholangitis', 'patients with PSC']","['Nonsteroidal Farnesoid X Receptor Agonist Cilofexor (GS-9674', 'nonsteroidal farnesoid X receptor agonist', 'placebo', 'cilofexor', 'cilofexor (formerly GS-9674', 'ursodeoxycholic acid']","['gamma-glutamyl transferase', 'safety and efficacy', 'aspartate aminotransferase', 'Adverse events', 'serum alkaline phosphatase (ALP', 'bile acids', 'liver biochemistry', 'liver biochemistries and markers of cholestasis', 'ALP', 'Baseline median serum ALP and bilirubin', 'Cholestasis and Liver Injury', 'serum ALP', 'alanine aminotransferase (ALT', 'Rates of grade 2 or 3 pruritus', 'Safety, tolerability, pharmacodynamic effects of cilofexor (serum C4 [7α-hydroxy-4-cholesten-3-one] and bile acids), and changes in liver biochemistry and serum fibrosis markers', 'serum alanine aminotransferase, aspartate aminotransferase, gamma-glutamyl transferase, tissue inhibitor of metalloproteinase 1, C-reactive protein, and bile acids']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0021390', 'cui_str': 'Inflammatory Bowel Diseases'}, {'cui': 'C0042105', 'cui_str': 'ursodesoxycholic acid'}, {'cui': 'C1623038', 'cui_str': 'Cirrhosis'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0687028', 'cui_str': 'Duct (organ) structure'}, {'cui': 'C0566602', 'cui_str': 'Primary sclerosing cholangitis (disorder)'}]","[{'cui': 'C4707406', 'cui_str': 'Product containing farnesoid X receptor agonist'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0042105', 'cui_str': 'ursodesoxycholic acid'}]","[{'cui': 'C0017040', 'cui_str': 'gammaglutamyltransferase'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0004002', 'cui_str': 'L-Aspartate-2-Oxoglutarate Aminotransferase'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036776', 'cui_str': 'Serum alkaline phosphatase measurement'}, {'cui': 'C0005390', 'cui_str': 'Bile Acids'}, {'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C0005477', 'cui_str': 'Biochemistry'}, {'cui': 'C0008370', 'cui_str': 'Bile Duct Obstruction'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0005437', 'cui_str': 'Bilirubin IX alpha'}, {'cui': 'C0160390', 'cui_str': 'Injury of liver (disorder)'}, {'cui': 'C0201836', 'cui_str': 'Alanine aminotransferase measurement (procedure)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0033774', 'cui_str': 'Pruritis'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0055520', 'cui_str': 'cholest-4-en-3-one'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C0145947', 'cui_str': 'TIMP-1'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}]",52.0,0.370652,All patients had serum alkaline phosphatase (ALP) > 1.67 × upper limit of normal and total bilirubin ≤ 2 mg/dL at baseline.,"[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Trauner', 'Affiliation': 'Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Aliya', 'Initials': 'A', 'LastName': 'Gulamhusein', 'Affiliation': 'University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Bilal', 'Initials': 'B', 'LastName': 'Hameed', 'Affiliation': 'University of California, San Francisco School of Medicine, San Francisco, CA.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Caldwell', 'Affiliation': 'University of Virginia, Charlottesville, VA.'}, {'ForeName': 'Mitchell L', 'Initials': 'ML', 'LastName': 'Shiffman', 'Affiliation': 'Bon Secours Liver Institute, Richmond, VA.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Landis', 'Affiliation': 'University of Washington School of Medicine, Seattle, WA.'}, {'ForeName': 'Bertus', 'Initials': 'B', 'LastName': 'Eksteen', 'Affiliation': 'Aspen Woods Clinic, Calgary, AB, Canada.'}, {'ForeName': 'Kosh', 'Initials': 'K', 'LastName': 'Agarwal', 'Affiliation': ""King's College, London, UK.""}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Muir', 'Affiliation': 'Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Rushbrook', 'Affiliation': 'Norfolk and Norwich University Hospital, Norfolk, UK.'}, {'ForeName': 'Xiaomin', 'Initials': 'X', 'LastName': 'Lu', 'Affiliation': 'Gilead Sciences, Inc., Foster City, CA.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'Gilead Sciences, Inc., Foster City, CA.'}, {'ForeName': 'Jen-Chieh', 'Initials': 'JC', 'LastName': 'Chuang', 'Affiliation': 'Gilead Sciences, Inc., Foster City, CA.'}, {'ForeName': 'Andrew N', 'Initials': 'AN', 'LastName': 'Billin', 'Affiliation': 'Gilead Sciences, Inc., Foster City, CA.'}, {'ForeName': 'Georgia', 'Initials': 'G', 'LastName': 'Li', 'Affiliation': 'Gilead Sciences, Inc., Foster City, CA.'}, {'ForeName': 'Chuhan', 'Initials': 'C', 'LastName': 'Chung', 'Affiliation': 'Gilead Sciences, Inc., Foster City, CA.'}, {'ForeName': 'G Mani', 'Initials': 'GM', 'LastName': 'Subramanian', 'Affiliation': 'Gilead Sciences, Inc., Foster City, CA.'}, {'ForeName': 'Robert P', 'Initials': 'RP', 'LastName': 'Myers', 'Affiliation': 'Gilead Sciences, Inc., Foster City, CA.'}, {'ForeName': 'Christopher L', 'Initials': 'CL', 'LastName': 'Bowlus', 'Affiliation': 'University of California Davis, Davis, CA.'}, {'ForeName': 'Kris V', 'Initials': 'KV', 'LastName': 'Kowdley', 'Affiliation': 'Liver Care Network and Organ Care Research, Swedish Medical Center, Seattle, WA.'}]","Hepatology (Baltimore, Md.)",['10.1002/hep.30509'] 1154,32083368,Dronedarone treatment following cardioversion in patients with atrial fibrillation/flutter: A post hoc analysis of the EURIDIS and ADONIS trials.,"INTRODUCTION The phase 3 EURIDIS and ADONIS studies evaluated dronedarone for atrial fibrillation (AF)/atrial flutter (AFL) recurrence in patients with nonpermanent AF. Here we assessed whether patient characteristics and/or treatment outcomes in these studies differed based on the need for cardioversion before randomization. METHODS Time to adjudicated first AF/AFL recurrence, symptomatic recurrence, cardiovascular hospitalization/death, and AF hospitalization, and safety were assessed by cardioversion status. RESULTS Of 1237 patients randomized (2:1 dronedarone:placebo), 364 required baseline cardioversion (dronedarone 243, placebo 121). Patients requiring cardioversion had a greater prevalence of cardiovascular comorbidities and shorter times to first AF/AFL recurrence compared with those not requiring cardioversion. Dronedarone was associated with longer median time to first AF/AFL recurrence vs placebo regardless of cardioversion status (cardioversion: 50 vs 15 days, hazard ratio [HR] 0.76; 95% confidence interval [CI], 0.59-0.97; P = .02; non-cardioversion: 150 vs 77 days, HR 0.76; 95% CI, 0.64-0.90; P < .01). Dronedarone was similarly associated with prolonged median time to symptomatic recurrence vs placebo in the cardioversion (347 vs 87 days, HR 0.65; 95% CI, 0.49-0.87) and non-cardioversion (288 vs 120 days, HR 0.74; 95% CI, 0.62-0.90) populations. Risk of cardiovascular hospitalization/death and first AF hospitalization was lower with dronedarone vs placebo regardless of cardioversion status, but differences were not statistically significant. The safety of dronedarone was similar in both groups. CONCLUSION Patients requiring baseline cardioversion represent a distinct population, having more underlying cardiovascular disease and experiencing a shorter time to AF/AFL recurrences. Dronedarone was associated with improved efficacy vs placebo regardless of cardioversion status.",2020,"Dronedarone was associated with longer median time to first AF/AFL recurrence vs placebo regardless of cardioversion status (cardioversion: 50 vs 15 days, hazard ratio [HR]","['patients with non-permanent AF', '1237 patients randomized (2:1', 'patients with atrial fibrillation']","['dronedarone:placebo', 'placebo', 'baseline cardioversion (dronedarone 243, placebo', 'dronedarone', 'Dronedarone']","['cardiovascular comorbidities and shorter times to first AF/AFL recurrence', 'prolonged median time to symptomatic recurrence', 'hazard ratio [HR', 'atrial fibrillation (AF)/atrial flutter (AFL) recurrence', 'longer median time to first AF/AFL recurrence', 'AFL recurrence, symptomatic recurrence, cardiovascular hospitalization/death, and AF hospitalization, and safety', 'Risk of cardiovascular hospitalization/death and first AF hospitalization']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205355', 'cui_str': 'Permanent (qualifier value)'}, {'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}]","[{'cui': 'C0766326', 'cui_str': 'dronedarone'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0013778', 'cui_str': 'Electrical Cardioversion'}]","[{'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0439590', 'cui_str': 'Prolonged (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",1237.0,0.281226,"Dronedarone was associated with longer median time to first AF/AFL recurrence vs placebo regardless of cardioversion status (cardioversion: 50 vs 15 days, hazard ratio [HR]","[{'ForeName': 'Munveer', 'Initials': 'M', 'LastName': 'Thind', 'Affiliation': 'Division of Cardiovascular Medicine, Lankenau Heart Institute, Wynnewood, Pennsylvania.'}, {'ForeName': 'Harry J', 'Initials': 'HJ', 'LastName': 'Crijns', 'Affiliation': 'Department of Cardiology, Maastricht University Medical Center and CARIM, Maastricht, Netherlands.'}, {'ForeName': 'Gerald V', 'Initials': 'GV', 'LastName': 'Naccarelli', 'Affiliation': 'Department of Medicine, Division of Cardiology, Penn State University College of Medicine, Hershey, Pennsylvania.'}, {'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'Reiffel', 'Affiliation': 'Department of Medicine, Division of Cardiology, Vagelos College of Physicians and Surgeons, Columbia University, New York, New York.'}, {'ForeName': 'Valérie', 'Initials': 'V', 'LastName': 'Corp Dit Genti', 'Affiliation': 'Sanofi-Aventis, Paris, France.'}, {'ForeName': 'Mattias', 'Initials': 'M', 'LastName': 'Wieloch', 'Affiliation': 'Sanofi-Aventis, Paris, France.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Koren', 'Affiliation': 'Sanofi US Inc, Bridgewater, New Jersey.'}, {'ForeName': 'Peter R', 'Initials': 'PR', 'LastName': 'Kowey', 'Affiliation': 'Division of Cardiovascular Medicine, Lankenau Heart Institute, Wynnewood, Pennsylvania.'}]",Journal of cardiovascular electrophysiology,['10.1111/jce.14405'] 1155,31694568,Thrombelastometry guided blood-component therapy after cardiac surgery: a randomized study.,"BACKGROUND Significant bleeding is a well known complication after cardiac surgical procedures and is associated with worse outcome. Thrombelastometry (ROTEM®) allows point-of-care testing of the coagulation status but only limited data is available yet. The aim was to evaluate the ROTEM®-guided blood component therapy in a randomized trial. METHODS In case of significant postoperative bleeding (> 200 ml/h) following elective isolated or combined cardiac surgical procedures (including 14% re-do procedures and 4% requiring circulatory arrest) patients were randomized to either a 4-chamber ROTEM®-guided blood-component transfusion protocol or received treatment guided by an algorithm based on standard coagulation testing (control). One hundred four patients (mean age: 67.2 ± 10.4 years, mean log. EuroSCORE 7.0 ± 8.8%) met the inclusion criteria. Mean CPB-time was 112.1 ± 55.1 min., mean cross-clamp time 72.5 ± 39.9 min. RESULTS Baseline demographics were comparable in both groups. Overall there was no significant difference in transfusion requirements regarding red blood cells, platelets, plasma, fibrinogen or pooled factors and the re-thoracotomy rate was comparable (ROTEM®: 29% vs. control: 25%). However, there was a trend towards less 24-h drainage loss visible in the ROTEM®-group (ROTEM®: 1599.1 ± 834.3 ml vs. control: 1867.4 ± 827.4 ml; p = 0.066). In the subgroup of patients with long CPB-times (> 115 min.; n = 55) known to exhibit an increased risk for diffuse coagulopathy ROTEM®-guided treatment resulted in a significantly lower 24-h drainage loss (ROTEM®: 1538.2 ± 806.4 ml vs. control: 2056.8 ± 974.5 ml; p = 0.032) and reduced 5-year mortality (ROTEM®: 0% vs. control: 15%; p = 0.03). CONCLUSION In case of postoperative bleeding following cardiac surgical procedures a treatment algorithm based on ""point-of-care"" 4-chamber ROTEM® seems to be at least as effective as standard therapy. In patients with long CPB-times ROTEM®-guided treatment may result in less bleeding, a marked reduction in costs and long-term mortality. TRIAL REGISTRATION German Clinical Trials Register, TRN: DRKS00017367 , date of registration: 05.06.2019, 'retrospectively registered'.",2019,"Overall there was no significant difference in transfusion requirements regarding red blood cells, platelets, plasma, fibrinogen or pooled factors and the re-thoracotomy rate was comparable (ROTEM®: 29% vs. control: 25%).","['after cardiac surgery', 'One hundred four patients (mean age: 67.2\u2009±\u200910.4\u2009years, mean log']","['Thrombelastometry guided blood-component therapy', 'ROTEM®-guided blood component therapy', '4-chamber ROTEM®-guided blood-component transfusion protocol or received treatment guided by an algorithm based on standard coagulation testing (control']","['Mean CPB-time', 'transfusion requirements regarding red blood cells, platelets, plasma, fibrinogen or pooled factors and the re-thoracotomy rate', '5-year mortality', 'costs and long-term mortality', '24-h drainage loss', 'postoperative bleeding', '24-h drainage loss visible']","[{'cui': 'C0524727', 'cui_str': 'Surgery, Cardiac'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0450129', 'cui_str': 'Blood component (substance)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0085430', 'cui_str': 'Blood Component Transfusion'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0002045'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0441509', 'cui_str': 'Coagulation - action (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0199960', 'cui_str': 'Transfusion - action (qualifier value)'}, {'cui': 'C1277078', 'cui_str': 'Red blood cells, blood product'}, {'cui': 'C0005821', 'cui_str': 'Platelets'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0982156', 'cui_str': 'fibrinogen (125I)'}, {'cui': 'C0337051', 'cui_str': 'Pool (environment)'}, {'cui': 'C0039991', 'cui_str': 'Thoracotomy'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0013103', 'cui_str': 'Drainage'}, {'cui': 'C0032788', 'cui_str': 'Blood Loss, Postoperative'}, {'cui': 'C0205379', 'cui_str': 'Visible (qualifier value)'}]",104.0,0.0846999,"Overall there was no significant difference in transfusion requirements regarding red blood cells, platelets, plasma, fibrinogen or pooled factors and the re-thoracotomy rate was comparable (ROTEM®: 29% vs. control: 25%).","[{'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Haensig', 'Affiliation': 'Department of Vascular Surgery, Cardiovascular Center, University of Leipzig, Liebigstr 20, 04103, Leipzig, Germany. mhaensig@gmail.com.'}, {'ForeName': 'Joerg', 'Initials': 'J', 'LastName': 'Kempfert', 'Affiliation': 'Department of Cardiothoracic and Vascular Surgery, German Heart Center Berlin, Berlin, Germany.'}, {'ForeName': 'Pia-Maria', 'Initials': 'PM', 'LastName': 'Kempfert', 'Affiliation': 'Department of Cardiothoracic and Vascular Surgery, German Heart Center Berlin, Berlin, Germany.'}, {'ForeName': 'Evaldas', 'Initials': 'E', 'LastName': 'Girdauskas', 'Affiliation': 'Department of Cardiac and Cardiovascular Surgery, University Heart Center Hamburg, Hamburg, Germany.'}, {'ForeName': 'Michael Andrew', 'Initials': 'MA', 'LastName': 'Borger', 'Affiliation': 'Clinic of Cardiac Surgery, Heart Center, University of Leipzig, Leipzig, Germany.'}, {'ForeName': 'Sven', 'Initials': 'S', 'LastName': 'Lehmann', 'Affiliation': 'Clinic of Cardiac Surgery, Heart Center, University of Leipzig, Leipzig, Germany.'}]",BMC anesthesiology,['10.1186/s12871-019-0875-7'] 1156,31703934,"Immunogenicity and safety of an adjuvanted inactivated polio vaccine, IPV-Al, compared to standard IPV: A phase 3 observer-blinded, randomised, controlled trial in infants vaccinated at 6, 10, 14 weeks and 9 months of age.","BACKGROUND A dose-sparing inactivated polio vaccine (IPV-Al), obtained by adsorption of inactivated virus to an aluminium hydroxide adjuvant, can help mitigate global supply and the cost constraints of IPV. The objective of this trial was to demonstrate the non-inferiority of IPV-Al to standard IPV. METHODS This phase 3, observer-blinded, randomised, controlled trial was conducted at 5 investigational sites in the Philippines. Infants not previously vaccinated with any polio vaccines were randomised to receive three IPV-Al (n = 502) or IPV vaccinations (n = 500) at 6, 10 and 14 weeks of age plus a booster vaccination at 9 months. The primary endpoint was type-specific seroconversion, defined as an antibody titre ≥4-fold higher than the estimated maternal antibody titre and a titre ≥8, one month after the primary vaccination series. RESULTS Seroconversion rates following primary vaccination with IPV-Al (483 infants in the per-protocol analysis set) or IPV (478 infants) were: polio type 1, 97.1% versus 99.0%; type 2, 94.2% versus 99.0%; and type 3, 98.3% versus 99.6%. IPV-Al was non-inferior to IPV, as the lower 95% confidence limits of the treatment differences were above the predefined -10%-point limit: type 1, -1.85% (-3.85; -0.05); type 2, -4.75% (-7.28; -2.52); type 3, -1.24 (-2.84; 0.13). The booster effect (geometric mean titre (GMT) post-booster / GMT pre-booster) was: type 1, 63 versus 43; type 2, 54 versus 47; type 3, 112 versus 80. IPV-Al was well tolerated with a safety profile comparable to that of IPV. Serious adverse events were recorded for 29 infants (5.8%, 37 events) in the IPV-Al group compared to 28 (5.6%, 48 events) in the IPV group. CONCLUSION Non-inferiority of IPV-Al to IPV with respect to seroconversion was confirmed and a robust booster response was demonstrated. Both vaccines had a similar safety profile. ClinicalTrials.gov identifier: NCT03032419.",2020,"Serious adverse events were recorded for 29 infants (5.8%, 37 events) in the IPV-Al group compared to 28 (5.6%, 48 events) in the IPV group. ","['infants vaccinated at 6, 10, 14\u202fweeks and 9\u202fmonths of age', 'Infants not previously vaccinated with any polio vaccines']","['IPV', 'aluminium hydroxide adjuvant', 'IPV vaccinations', 'sparing inactivated polio vaccine (IPV-Al', 'adjuvanted inactivated polio vaccine, IPV-Al']","['type-specific seroconversion, defined as an antibody titre ≥4-fold higher than the estimated maternal antibody titre', 'Serious adverse events', 'Seroconversion rates', 'Immunogenicity and safety']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0032371', 'cui_str': 'Poliomyelitis Infection'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}]","[{'cui': 'C0276240', 'cui_str': 'Infectious pustular vulvovaginitis (disorder)'}, {'cui': 'C0002371', 'cui_str': 'aluminium hydroxide'}, {'cui': 'C0032371', 'cui_str': 'Poliomyelitis Infection'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}]","[{'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C4042908', 'cui_str': 'Seroconversion'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C1287242', 'cui_str': 'Finding of antibody titer (finding)'}, {'cui': 'C0185026', 'cui_str': 'Plication - action (qualifier value)'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0729663', 'cui_str': 'Maternal antibody (substance)'}, {'cui': 'C0475208', 'cui_str': 'TITR'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",483.0,0.240911,"Serious adverse events were recorded for 29 infants (5.8%, 37 events) in the IPV-Al group compared to 28 (5.6%, 48 events) in the IPV group. ","[{'ForeName': 'Lulu C', 'Initials': 'LC', 'LastName': 'Bravo', 'Affiliation': 'University of the Philippines Manila, Manila, Philippines.'}, {'ForeName': 'Josefina C', 'Initials': 'JC', 'LastName': 'Carlos', 'Affiliation': 'University of the East-Ramon Magsaysay Memorial Medical Center Incorporated, Manila, Philippines.'}, {'ForeName': 'Salvacion R', 'Initials': 'SR', 'LastName': 'Gatchalian', 'Affiliation': 'UP CM University of the Philippines, Manila, Department of Pediatrics. Philippine General Hospital, Philippines.'}, {'ForeName': 'May Emmeline B', 'Initials': 'MEB', 'LastName': 'Montellano', 'Affiliation': 'Mary Chiles General Hospital, Sampaloc, Manila, Philippines.'}, {'ForeName': 'Charissa Fay Corazon B', 'Initials': 'CFCB', 'LastName': 'Tabora', 'Affiliation': 'Research Institute for Tropical Medicine, Muntinlupa City, Metro Manila, Philippines.'}, {'ForeName': 'Birgit', 'Initials': 'B', 'LastName': 'Thierry-Carstensen', 'Affiliation': 'Statens Serum Institut, 5 Artillerivej, 2300 Copenhagen S, Denmark. Electronic address: BTC@ssi.dk.'}, {'ForeName': 'Pernille Nyholm', 'Initials': 'PN', 'LastName': 'Tingskov', 'Affiliation': 'Statens Serum Institut, 5 Artillerivej, 2300 Copenhagen S, Denmark. Electronic address: PNT@ssi.dk.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Sørensen', 'Affiliation': 'AJ Vaccines, 5 Artillerivej, 2300 Copenhagen S, Denmark. Electronic address: CHS@ajvaccines.com.'}, {'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Wachmann', 'Affiliation': 'Larix A/S, Lyskær 8b, 2730 Herlev, Denmark. Electronic address: HEW@larixcro.com.'}, {'ForeName': 'Ananda S', 'Initials': 'AS', 'LastName': 'Bandyopadhyay', 'Affiliation': 'Bill & Melinda Gates Foundation, Seattle, WA, USA. Electronic address: Ananda.bandyopadhyay@gatesfoundation.org.'}, {'ForeName': 'Pernille Ingemann', 'Initials': 'PI', 'LastName': 'Nielsen', 'Affiliation': 'AJ Vaccines, 5 Artillerivej, 2300 Copenhagen S, Denmark. Electronic address: PXN@ajvaccines.com.'}, {'ForeName': 'Mie Vestergaard', 'Initials': 'MV', 'LastName': 'Kusk', 'Affiliation': 'AJ Vaccines, 5 Artillerivej, 2300 Copenhagen S, Denmark. Electronic address: MHK@ajvaccines.com.'}]",Vaccine,['10.1016/j.vaccine.2019.10.064'] 1157,31703936,Booster vaccination with a fractional dose of an oral cholera vaccine induces comparable vaccine-specific antibody avidity as a full dose: A randomised clinical trial.,"Antibody avidity is an important measure of the quality of vaccine-induced immune responses. Murine and human studies suggest that antibody avidity may be augmented by limiting access to antigen. The primary objective of this study was to evaluate in primed Swedish adults if booster vaccination with fractional doses (1/5th and 1/25th) of a model oral vaccine, the cholera vaccine Dukoral®, results in higher avidity antibody responses compared to boosting with a full vaccine dose. We also evaluated if fractional booster vaccination elicited similar magnitudes of antibody response compared to a full dose, and if the previously observed increase in antibody avidity after booster vaccination 1-2 years later occurred when boosting after a shorter interval. To this end, a randomised, open-label, exploratory Phase-II trial was performed. Swedish adults (n = 44), primed with two full doses of Dukoral®, were randomised into three groups and given a booster dose at either full (n = 14), 1/5th (n = 17) or 1/25th (n = 13) dose four months later. Antibody responses to cholera toxin B-subunit (CTB) were measured in serum and mucosal antibody in lymphocyte secretions (ALS). We found that the 1/5th and 1/25th booster doses had similar abilities as the full dose to induce significantly higher avidity anti-CTB antibody responses in both ALS and serum samples, as compared to after priming vaccination. There was a non-significant trend to lower magnitudes of ALS and serum IgA responses after the 1/5th compared to the full booster dose, and responses after the 1/25th dose were significantly lower. Our findings suggest fractional booster doses of Dukoral® four months after priming result in anti-toxoid mucosal antibody responses with increased antibody avidity compared to after priming vaccinations. ISRCTN registry identifier 11806026.",2020,"There was a non-significant trend to lower magnitudes of ALS and serum IgA responses after the 1/5th compared to the full booster dose, and responses after the 1/25th dose were significantly lower.","['Swedish adults (n\u202f=\u202f44), primed with two full doses of Dukoral®']","['booster vaccination with fractional doses (1/5th and 1/25th) of a model oral vaccine', 'oral cholera vaccine', 'cholera toxin B-subunit (CTB']","['avidity anti-CTB antibody responses', 'ALS and serum IgA responses', 'antibody response', 'higher avidity antibody responses', 'antibody avidity']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C3713288', 'cui_str': 'Dukoral'}]","[{'cui': 'C0020975', 'cui_str': 'Immunization, Booster'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0008359', 'cui_str': 'Cholera Vaccine'}, {'cui': 'C0008357', 'cui_str': 'Choleragenoid'}]","[{'cui': 'C0003261', 'cui_str': 'Antibody Response'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0020835', 'cui_str': 'Immunoglobulin A'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0003256', 'cui_str': 'Antibody Avidity'}]",,0.0446152,"There was a non-significant trend to lower magnitudes of ALS and serum IgA responses after the 1/5th compared to the full booster dose, and responses after the 1/25th dose were significantly lower.","[{'ForeName': 'Lynda', 'Initials': 'L', 'LastName': 'Mottram', 'Affiliation': 'Gothenburg University Vaccine Research Institute (GUVAX), Dept. of Microbiology and Immunology, University of Gothenburg, Sweden. Electronic address: lynda.mottram@gu.se.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Lundgren', 'Affiliation': 'Gothenburg University Vaccine Research Institute (GUVAX), Dept. of Microbiology and Immunology, University of Gothenburg, Sweden. Electronic address: anna.lundgren@microbio.gu.se.'}, {'ForeName': 'Ann-Mari', 'Initials': 'AM', 'LastName': 'Svennerholm', 'Affiliation': 'Gothenburg University Vaccine Research Institute (GUVAX), Dept. of Microbiology and Immunology, University of Gothenburg, Sweden. Electronic address: ann-mari.svennerholm@microbio.gu.se.'}, {'ForeName': 'Susannah', 'Initials': 'S', 'LastName': 'Leach', 'Affiliation': 'Gothenburg University Vaccine Research Institute (GUVAX), Dept. of Microbiology and Immunology, University of Gothenburg, Sweden; Dept. of Clinical Pharmacology, Sahlgrenska University Hospital, Gothenburg, Sweden. Electronic address: susannah.leach@microbio.gu.se.'}]",Vaccine,['10.1016/j.vaccine.2019.10.050'] 1158,31704740,Multicenter Randomized Controlled Trial of Vitamin K Antagonist Replacement by Rivaroxaban with or without Vitamin K2 in Hemodialysis Patients with Atrial Fibrillation: the Valkyrie Study.,"BACKGROUND Vitamin K antagonists (VKAs), although commonly used to reduce thromboembolic risk in atrial fibrillation, have been incriminated as probable cause of accelerated vascular calcification (VC) in patients on hemodialysis. Functional vitamin K deficiency may further contribute to their susceptibility for VC. We investigated the effect of vitamin K status on VC progression in 132 patients on hemodialysis with atrial fibrillation treated with VKAs or qualifying for anticoagulation. METHODS Patients were randomized to VKAs with target INR 2-3, rivaroxaban 10 mg daily, or rivaroxaban 10 mg daily plus vitamin K2 2000 µ g thrice weekly during 18 months. Systemic dp-ucMGP levels were quantified to assess vascular vitamin K status. Cardiac and thoracic aorta calcium scores and pulse wave velocity were measured to evaluate VC progression. RESULTS Baseline dp-ucMGP was severely elevated in all groups. Initiation or continuation of VKAs further increased dp-ucMGP, whereas levels decreased in the rivaroxaban group and to a larger extent in the rivaroxaban+vitamin K2 group, but remained nevertheless elevated. Changes in coronary artery, thoracic aorta, and cardiac valve calcium scores and pulse wave velocity were not significantly different among the treatment arms. All cause death, stroke, and cardiovascular event rates were similar between the groups. Bleeding outcomes were not significantly different, except for a lower number of life-threatening and major bleeding episodes in the rivaroxaban arms versus the VKA arm. CONCLUSIONS Withdrawal of VKAs and high-dose vitamin K2 improve vitamin K status in patients on hemodialysis, but have no significant favorable effect on VC progression. Severe bleeding complications may be lower with rivaroxaban than with VKAs.",2020,"Bleeding outcomes were not significantly different, except for a lower number of life-threatening and major bleeding episodes in the rivaroxaban arms versus the VKA arm. ","['Patients', 'patients on hemodialysis', 'Hemodialysis Patients with Atrial Fibrillation', '132 patients on hemodialysis with atrial fibrillation treated with VKAs or qualifying for anticoagulation']","['rivaroxaban', 'vitamin K status', 'rivaroxaban 10 mg daily, or rivaroxaban 10 mg daily plus vitamin K2 2000', 'Vitamin K antagonists (VKAs', 'Rivaroxaban with or without Vitamin K2', 'Vitamin K Antagonist Replacement']","['VC progression', 'Initiation or continuation of VKAs further increased dp-ucMGP', 'Severe bleeding complications', 'life-threatening and major bleeding episodes', 'All cause death, stroke, and cardiovascular event rates', 'vitamin K status', 'Changes in coronary artery, thoracic aorta, and cardiac valve calcium scores and pulse wave velocity', 'Bleeding outcomes', 'Cardiac and thoracic aorta calcium scores and pulse wave velocity', 'Systemic dp-ucMGP levels', 'vascular vitamin K status']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}]","[{'cui': 'C1739768', 'cui_str': 'rivaroxaban'}, {'cui': 'C0042879', 'cui_str': 'Vitamin K measurement (procedure)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C3162458', 'cui_str': 'rivaroxaban 10 MG [Xarelto]'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0065936', 'cui_str': 'menatetrenone'}, {'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C3653316', 'cui_str': 'Vitamin K antagonists'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}]","[{'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation (observable entity)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0042879', 'cui_str': 'Vitamin K measurement (procedure)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0205042', 'cui_str': 'Coronary artery structure'}, {'cui': 'C1522460', 'cui_str': 'Thoracic aorta structure (body structure)'}, {'cui': 'C0018826', 'cui_str': 'Cardiac Valves'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C3494431', 'cui_str': 'Pulse Wave Velocity'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",132.0,0.173215,"Bleeding outcomes were not significantly different, except for a lower number of life-threatening and major bleeding episodes in the rivaroxaban arms versus the VKA arm. ","[{'ForeName': 'An S', 'Initials': 'AS', 'LastName': 'De Vriese', 'Affiliation': 'Division of Nephrology and Infectious Diseases and an.devriese@azsintjan.be.'}, {'ForeName': 'Rogier', 'Initials': 'R', 'LastName': 'Caluwé', 'Affiliation': 'Division of Nephrology and.'}, {'ForeName': 'Lotte', 'Initials': 'L', 'LastName': 'Pyfferoen', 'Affiliation': 'Department of Medical Imaging, AZ Sint-Jan Brugge, Brugge, Belgium.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'De Bacquer', 'Affiliation': 'Public Health, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Koen', 'Initials': 'K', 'LastName': 'De Boeck', 'Affiliation': 'Division of Nephrology and.'}, {'ForeName': 'Joost', 'Initials': 'J', 'LastName': 'Delanote', 'Affiliation': 'Department of Medical Imaging, AZ Sint-Jan Brugge, Brugge, Belgium.'}, {'ForeName': 'Didier', 'Initials': 'D', 'LastName': 'De Surgeloose', 'Affiliation': 'Department of Medical Imaging, ZNA Middelheim, Antwerp, Belgium; and.'}, {'ForeName': 'Piet', 'Initials': 'P', 'LastName': 'Van Hoenacker', 'Affiliation': 'Department of Medical Imaging, Onze Lieve Vrouw Hospital, Aalst, Belgium.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Van Vlem', 'Affiliation': 'Division of Nephrology and.'}, {'ForeName': 'Francis', 'Initials': 'F', 'LastName': 'Verbeke', 'Affiliation': 'Division of Nephrology, University Hospital, Ghent, Belgium.'}]",Journal of the American Society of Nephrology : JASN,['10.1681/ASN.2019060579'] 1159,30833130,"Effect of a Short-term Lifestyle Modification Program on Quality of Life, Anthropometric Characteristics and CD4+T Cell Count of HIV Infected Patients in Tehran/Iran: A Randomized Controlled Trial.","CONTEXT Increasing physical activity and promoting healthy behaviors may play a key role in reducing the adverse effects of antiretroviral therapy and HIV. OBJECTIVE This study investigated the effects of an 8-week lifestyle modification program (LMP) on quality of life, anthropometric characteristics and CD4+T cell count of people living with HIV (PLWH). METHODS Thirty PLWH taking ART were randomly assigned to a lifestyle modification program (LMP) (n = 15) or standard care control (CON) group (n = 15). All volunteers underwent body composition, CD4+T cell count measurement and quality of life assessments at the beginning and end of a two-month experimental period. RESULTS At follow-up, we observed a significant increase in CD4+T cell count (117.52 cells/mm 3 ; 95% CI, 36.59-198.45) and all subscales and total quality of life score (Short-Form 36 (SF-36) in the LMP group. While we did not observe a significant change in body composition for the LMP group, we did observe a significant increase in body fat (1.75%; 95% CI, 0.15, 2.33) and a reduction in lean body mass (-1.26; 95% CI, -1.26, -2.39) for the CON group. CONCLUSION A LMP can be safely used as an effective intervention for improving quality of life and immune competence of PLWH who lack time to participate in a structured exercise regimen. TRIAL REGISTRATION IRCT 201604034076N18. Registered: 2016-05-05 .web address of TRIAL: en.search.irct.ir/trial/4262.",2019,"A LMP can be safely used as an effective intervention for improving quality of life and immune competence of PLWH who lack time to participate in a structured exercise regimen. ","['Thirty PLWH taking ART', 'Registered: 2016-05-05 .web', 'people living with HIV (PLWH', 'HIV infected patients in Tehran/Iran']","['short-term lifestyle modification program', '8-week lifestyle modification program (LMP', 'lifestyle modification program (LMP) (n\xa0=\xa015) or standard care control (CON']","['subscales and total quality of life score', 'body composition', 'body composition, CD4+T cell count measurement and quality of life assessments', 'CD4+T cell count', 'body fat', 'lean body mass', 'quality of life, anthropometric characteristics and CD4+T cell count']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0022065', 'cui_str': 'Islamic Republic of Iran'}]","[{'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0007584', 'cui_str': 'Cell Number'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0344335', 'cui_str': 'Body Fat'}, {'cui': 'C0424678', 'cui_str': 'Lean body mass (observable entity)'}]",,0.0824664,"A LMP can be safely used as an effective intervention for improving quality of life and immune competence of PLWH who lack time to participate in a structured exercise regimen. ","[{'ForeName': 'Morteza', 'Initials': 'M', 'LastName': 'Ghayomzadeh', 'Affiliation': 'Department of Sport Sciences, Faculty of Humanities, Tarbiat Modares University, Tehran, Iran.'}, {'ForeName': 'Maede Sadat', 'Initials': 'MS', 'LastName': 'Etesami', 'Affiliation': 'Faculty of Psychology and Education, University of Tehran, Iran.'}, {'ForeName': 'Conrad P', 'Initials': 'CP', 'LastName': 'Earnest', 'Affiliation': 'Exercise and Sport Nutrition Laboratory, Texas A&M University, College Station, TX, USA.'}, {'ForeName': 'Sajjad', 'Initials': 'S', 'LastName': 'Rezaei', 'Affiliation': 'Department of Sport Sciences, Faculty of Humanities, Tarbiat Modares University, Tehran, Iran.'}, {'ForeName': 'James Wilfred', 'Initials': 'JW', 'LastName': 'Navalta', 'Affiliation': 'Department of Kinesiology and Nutrition Sciences, University of Nevada, Las Vegas, NV, USA.'}, {'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Taj', 'Affiliation': 'Iranian Research Center for HIV/AIDS, Iranian Institute for Reduction of High-Risk Behaviors, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'SeyedAhmad', 'Initials': 'S', 'LastName': 'SeyedAlinaghi', 'Affiliation': 'Iranian Research Center for HIV/AIDS, Iranian Institute for Reduction of High-Risk Behaviors, Tehran University of Medical Sciences, Tehran, Iran. Electronic address: a_alinaghi@sina.tums.ac.ir.'}, {'ForeName': 'Minoo', 'Initials': 'M', 'LastName': 'Mohraz', 'Affiliation': 'Iranian Research Center for HIV/AIDS, Iranian Institute for Reduction of High-Risk Behaviors, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Gharakhanlou', 'Affiliation': 'Department of Sport Sciences, Faculty of Humanities, Tarbiat Modares University, Tehran, Iran.'}, {'ForeName': 'Fabrício Azevedo', 'Initials': 'FA', 'LastName': 'Voltarelli', 'Affiliation': 'Graduation Program of Health Sciences, Faculty of Medicine, Federal University of Mato Grosso, Cuiabá, Brazil.'}]","Explore (New York, N.Y.)",['10.1016/j.explore.2019.01.004'] 1160,30445275,Effects of time-varying changes in tobacco and alcohol use on depressive symptoms following pharmaco-behavioral treatment for smoking and heavy drinking.,"BACKGROUND Complete abstinence from alcohol as well as smoking cessation have been shown to predict reductions in depressive symptoms over time. However, whether reducing alcohol use or smoking positively affect depressive symptoms has yet to be examined. The current study examined depressive symptoms as a function of time-varying changes in alcohol use and smoking status following a pharmaco-behavioral treatment addressing smoking cessation and alcohol reduction. METHODS Participants were heavy-drinking smokers (n = 150) followed for 26 weeks after their quit smoking date, with assessments of smoking, alcohol use, and depressive symptoms at baseline and 2, 8, 16, and 26 weeks. RESULTS Abstinence from smoking was associated with significantly lower depressive symptoms, as compared to little to no reduction in smoking (B = -6.1) as well as significant reductions in smoking (B = 4.01). Exploratory analyses, which excluded observations in which a participant was abstinent, revealed a significant effect of percent change in cigarettes smoked, modeled continuously, on depressive symptoms, (B = 4.39). By contrast, no differences were observed in depressive symptoms in relation to changes in alcohol use. CONCLUSION It appears that smoking abstinence is associated with improvements in depression as compared to any level of sustained or reduced use and that the magnitude of smoking reduction may be associated with lower depressive symptoms among those who did not quit successfully. If replicated, these findings may inform treatment for individuals for whom depression is a major barrier to cessation and who have been unable or are unwilling to be completely abstinent from smoking.",2019,"RESULTS Abstinence from smoking was associated with significantly lower depressive symptoms, as compared to little to no reduction in smoking (B = -6.1) as well as significant reductions in smoking (B = 4.01).","['depressive symptoms following pharmaco-behavioral treatment for smoking and heavy drinking', 'Participants were heavy-drinking smokers (n\u2009=\u2009150) followed for 26 weeks after their quit smoking date, with assessments of smoking, alcohol use, and depressive symptoms at baseline and 2, 8, 16, and 26 weeks']",[],['depressive symptoms'],"[{'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0439539', 'cui_str': 'Heavy sensation quality'}, {'cui': 'C0684271', 'cui_str': 'Drinkings'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C0011008', 'cui_str': 'Dates'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}]",[],"[{'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}]",,0.0199516,"RESULTS Abstinence from smoking was associated with significantly lower depressive symptoms, as compared to little to no reduction in smoking (B = -6.1) as well as significant reductions in smoking (B = 4.01).","[{'ForeName': 'William V', 'Initials': 'WV', 'LastName': 'Lechner', 'Affiliation': 'Department of Psychological Sciences, Kent State University, 144 Kent Hall, P.O. Box 5190, Kent, OH, 44242-0001, USA; Center for Alcohol and Addiction Studies, Brown University School of Public Health, 121 South Main Street, Box G-S121-5, Providence, RI, USA. Electronic address: wlechner@kent.edu.'}, {'ForeName': 'Natasha K', 'Initials': 'NK', 'LastName': 'Sidhu', 'Affiliation': 'Department of Psychological Sciences, Kent State University, 144 Kent Hall, P.O. Box 5190, Kent, OH, 44242-0001, USA.'}, {'ForeName': 'Patricia A', 'Initials': 'PA', 'LastName': 'Cioe', 'Affiliation': 'Center for Alcohol and Addiction Studies, Brown University School of Public Health, 121 South Main Street, Box G-S121-5, Providence, RI, USA.'}, {'ForeName': 'Christopher W', 'Initials': 'CW', 'LastName': 'Kahler', 'Affiliation': 'Center for Alcohol and Addiction Studies, Brown University School of Public Health, 121 South Main Street, Box G-S121-5, Providence, RI, USA.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2018.09.030'] 1161,30789583,Chronic Effects of Static and Dynamic Stretching on Hamstrings Eccentric Strength and Functional Performance: A Randomized Controlled Trial.,"Barbosa, GM, Trajano, GS, Dantas, GAF, Silva, BR, and Vieira, WHB. Chronic effects of static and dynamic stretching on hamstrings eccentric strength and functional performance: A randomized controlled trial. J Strength Cond Res 34(7): 2031-2039, 2020-The purpose of this study was to investigate the effect of static or dynamic stretching training program on hamstrings eccentric peak torque and functional performance. Forty-five active healthy men were randomly allocated into 3 groups (n = 15 per group): no stretching (control), static stretching (3 sets of 30 seconds), and dynamic stretching (3 sets of 30 repetitions). Static and dynamic stretching protocols on the hamstring muscles were performed 3 times a week until complete 10 sessions. Isokinetic knee flexor eccentric peak torque (60°·s), triple hop distance, and modified 20-m sprint time were assessed in a random order before and after stretching training. A mixed-design analysis of variance was performed, with an alpha level of 0.05. There was a significant decrease of eccentric peak torque (p ≤ 0.0001, -15.4 ± 10.4%, within-group effect size: 1.03) after static stretching training. The static stretching training reduced eccentric torque when compared with no stretching (-7.6 ± 21.7%, between-group effect size: 0.50) and dynamic stretching (-7.8 ± 29.8%, between-group effect size: 0.51). Moreover, the reached distance on triple hop test was also reduced after static stretching protocol (p = 0.009, -3.7 ± 4.1%, within-group effect size: 0.29). These findings suggest that static stretching training is sufficient to produce meaningful reductions on hamstrings eccentric torque and functional performance. Based on the results of this study, caution should be taken when prescribing of static stretching training in isolation when the purpose is to improve performance, and indirectly, to prevent hamstring strain injuries due to its possible negative effects on hopping performance and knee flexor eccentric torque.",2020,"Moreover, the reached distance on triple hop test was also reduced after static stretching protocol (p = 0.009, -3.7 ± 4.1%, within-group effect size: 0.29).",['Forty-five active healthy men'],"['J Strength Cond Res XX(X', 'Static and dynamic stretching protocols', 'static and dynamic stretching', 'Static and Dynamic Stretching', 'static stretching training', 'static or dynamic stretching training program', 'no stretching (control), static stretching (3 sets of 30 seconds), and dynamic stretching']","['hamstrings eccentric strength and functional performance', 'Isokinetic knee flexor eccentric peak torque (60°·s), triple hop distance, and modified 20-m sprint time', 'Hamstrings Eccentric Strength and Functional Performance', 'eccentric torque', 'hamstrings eccentric peak torque and functional performance', 'Barbosa, GM, Trajano, GS, Dantas, GAF, Silva, BR, and Vieira, WHB', 'eccentric peak torque', 'hamstrings eccentric torque and functional performance']","[{'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C0441463', 'cui_str': 'Static (qualifier value)'}, {'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C0600080', 'cui_str': 'Stretching procedure (procedure)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C1720869', 'cui_str': 'Dynamic Stretching'}, {'cui': 'C1720875', 'cui_str': 'Static Stretching'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}]","[{'cui': 'C0439740', 'cui_str': 'Eccentric (qualifier value)'}, {'cui': 'C3853978'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0376590', 'cui_str': 'Torque'}, {'cui': 'C0205174', 'cui_str': 'Triple (qualifier value)'}, {'cui': 'C4018995', 'cui_str': 'Hop'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",45.0,0.0212715,"Moreover, the reached distance on triple hop test was also reduced after static stretching protocol (p = 0.009, -3.7 ± 4.1%, within-group effect size: 0.29).","[{'ForeName': 'Germanna M', 'Initials': 'GM', 'LastName': 'Barbosa', 'Affiliation': 'Neuromuscular Performance Analysis Laboratory, Department of Physical Therapy, Federal University of Rio Grande do Norte, Natal, Brazil.'}, {'ForeName': 'Gabriel S', 'Initials': 'GS', 'LastName': 'Trajano', 'Affiliation': 'School of Exercise and Nutrition Sciences, Institute of Health and Biomedical Innovation, Queensland University of Technology, Brisbane, Australia.'}, {'ForeName': 'Glauko A F', 'Initials': 'GAF', 'LastName': 'Dantas', 'Affiliation': 'Neuromuscular Performance Analysis Laboratory, Department of Physical Therapy, Federal University of Rio Grande do Norte, Natal, Brazil.'}, {'ForeName': 'Bianca R', 'Initials': 'BR', 'LastName': 'Silva', 'Affiliation': 'Neuromuscular Performance Analysis Laboratory, Department of Physical Therapy, Federal University of Rio Grande do Norte, Natal, Brazil.'}, {'ForeName': 'Wouber H Brito', 'Initials': 'WHB', 'LastName': 'Vieira', 'Affiliation': 'Neuromuscular Performance Analysis Laboratory, Department of Physical Therapy, Federal University of Rio Grande do Norte, Natal, Brazil.'}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000003080'] 1162,30821349,Dexmedetomidine versus propofol at different sedation depths during drug-induced sleep endoscopy: A randomized trial.,"OBJECTIVES/HYPOTHESIS The aim of this study was to compare the effect of dexmedetomidine and propofol on airway dynamics, cardiorespiratory system, and emergence following drug-induced sleep endoscopy (DISE). STUDY DESIGN Prospective, randomized, single-blinded study. METHODS Sixty patients age 18 to 65 years in American Society of Anesthesiologists physical status groups 1 and 2 scheduled to undergo DISE were randomly allocated to either Group P (N = 30; receiving propofol infusion at 50-150 μg/kg/min) or Group D (N = 30; receiving dexmedetomidine bolus of 1 μg/kg followed by infusion at 0.5-1.0 μg/kg/hr). DISE was done at light sleep and deep sleep. Airway obstruction at tongue base was recorded as primary outcome. Airway obstruction at velum, oropharyngeal lateral wall, and epiglottis level during light and deep sedation, hemodynamic and respiratory parameters, time to attain sufficient sedation, time for emergence from sedation, and any adverse events during DISE with the two study drugs were recorded as secondary outcomes. RESULTS There was a greater degree of obstruction at the tongue base level (P = 0.001) and Oropharynx level (P = 0.017) in Group P compared with Group D during deep sedation. Increase in airway obstruction from light to deep sleep was seen with propofol at the oropharynx (P = 0.0185) and tongue base (P = 0.0108) levels. Two patients (6.6%) in Group D and 10 patients (33.3%) in Group P showed oxygen saturation below the minimum oxygen saturation recorded during polysomnography. Time to open eyes to call after stopping sedation was significantly less in Group P (P = 0.005). CONCLUSIONS Dexmedetomidine shows a lesser degree of airway collapse and higher oxygen saturation levels at greater sedation depth during DISE. Propofol has a faster onset and emergence from sedation. LEVEL OF EVIDENCE 1b Laryngoscope, 130:257-262, 2020.",2020,"Time to open eyes to call after stopping sedation was significantly less in Group P (P = 0.005). ","['Sixty patients age 18 to 65\u2009years in American Society of Anesthesiologists physical status groups 1 and 2 scheduled to undergo DISE', 'drug-induced sleep endoscopy']","['Dexmedetomidine', 'DISE', 'propofol', 'propofol infusion', 'dexmedetomidine and propofol', 'dexmedetomidine', 'Propofol']","['Oropharynx level', 'degree of airway collapse and higher oxygen saturation levels', 'oxygen saturation below the minimum oxygen saturation', 'Airway obstruction at velum, oropharyngeal lateral wall, and epiglottis level during light and deep sedation, hemodynamic and respiratory parameters, time to attain sufficient sedation, time for emergence from sedation, and any adverse events', 'degree of obstruction', 'airway obstruction from light to deep sleep', 'airway dynamics, cardiorespiratory system, and emergence following drug-induced sleep endoscopy (DISE']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0441861', 'cui_str': 'Group 1 (qualifier value)'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0458082', 'cui_str': 'Drug-induced (qualifier value)'}, {'cui': 'C0396283', 'cui_str': 'Sleep nasendoscopy (procedure)'}]","[{'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}]","[{'cui': 'C0521367', 'cui_str': 'Oropharynxs'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C0458827', 'cui_str': 'Airway structure (body structure)'}, {'cui': 'C0392748', 'cui_str': 'Collapsed (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0523807', 'cui_str': 'Oximetry'}, {'cui': 'C0001883', 'cui_str': 'Airway Obstruction'}, {'cui': 'C1522409', 'cui_str': 'Oropharyngeal route (qualifier value)'}, {'cui': 'C0205093', 'cui_str': 'Lateral (qualifier value)'}, {'cui': 'C0205380', 'cui_str': 'Walled (qualifier value)'}, {'cui': 'C0014540', 'cui_str': 'Epiglottic Cartilage'}, {'cui': 'C0332264', 'cui_str': 'Light (weight) (qualifier value)'}, {'cui': 'C1956064', 'cui_str': 'Deep Sedation'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205410', 'cui_str': 'Sufficient (qualifier value)'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0234451', 'cui_str': 'Sleep, Slow-Wave'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0458082', 'cui_str': 'Drug-induced (qualifier value)'}, {'cui': 'C0396283', 'cui_str': 'Sleep nasendoscopy (procedure)'}]",60.0,0.101284,"Time to open eyes to call after stopping sedation was significantly less in Group P (P = 0.005). ","[{'ForeName': 'Tonsy V', 'Initials': 'TV', 'LastName': 'Padiyara', 'Affiliation': 'Department of Anesthesia and Intensive Care, Postgraduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Sandeep', 'Initials': 'S', 'LastName': 'Bansal', 'Affiliation': 'Department of Anesthesia and Intensive Care, Postgraduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Divya', 'Initials': 'D', 'LastName': 'Jain', 'Affiliation': 'Department of Anesthesia and Intensive Care, Postgraduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Suman', 'Initials': 'S', 'LastName': 'Arora', 'Affiliation': 'Department of Anesthesia and Intensive Care, Postgraduate Institute of Medical Education and Research, Chandigarh, India.'}, {'ForeName': 'Komal', 'Initials': 'K', 'LastName': 'Gandhi', 'Affiliation': 'Department of Anesthesia and Intensive Care, Postgraduate Institute of Medical Education and Research, Chandigarh, India.'}]",The Laryngoscope,['10.1002/lary.27903'] 1163,30801952,"Ultrasound Measures of the Abdominal Wall in Patients with Low Back Pain Before and After an 8-week Lumbar Stabilization Exercise Program, and Their Association With Clinical Outcomes.","BACKGROUND Lumbar stabilization exercise programs (LSEPs) act positively on clinical outcome measures in patients with low back pain (LBP), but the underlying mechanisms are not well understood. Among the various neuromuscular mechanisms, a good candidate is better activation of the abdominal wall, as measured with rehabilitative ultrasound imaging (RUSI). OBJECTIVES To determine whether RUSI measures are (1) sensitive to LBP status and treatment (LSEP) and (2) correlate with clinical outcomes following the LSEP. DESIGN An exploratory one-arm clinical trial with healthy participants as a control group. SETTING LSEP was delivered in a clinical setting; outcomes were measured in a laboratory setting. PARTICIPANTS Thirty-one patients with nonacute LBP and 30 healthy controls. METHODS Outcome measures were performed before and after an 8-week LSEP in patients with LBP, and with the same time interval for control participants to compare with patients at baseline. MAIN OUTCOME MEASUREMENTS Pain, disability, as well as static (at rest) and dynamic (percent thickness change) RUSI measures for abdominal muscles (transversus abdominis, internal oblique [IO], and external oblique [EO]). RESULTS Patients did not produce systematic changes in RUSI measures relative to controls, even if patients had significant improvement in pain and disability. However, the correlational analyses between the absolute change (pre- to post-LSEP) (1) of EO and IO thickness (in mm) at rest (bilaterally), and (2) in pain following the LSEP were significant and consistent (range: .36-.45) in patients. CONCLUSIONS Although positive clinical improvements were observed following LSEP, there were minimal systematic changes in RUSI measures, likely because patients were not different from controls at baseline. Correlational analyses, however, indicated that greater reductions in pain were associated with reduced thickness of the EO and IO following the LSEP, suggesting the presence of some heterogeneity (or clinical subgroups) among the patients. LEVEL OF EVIDENCE II.",2019,"RESULTS Patients did not produce systematic changes in RUSI measures relative to controls, even if patients had significant improvement in pain and disability.","['patients with LBP, and with the same time interval for control participants to compare with patients at baseline', 'Thirty-one patients with nonacute LBP and 30 healthy controls', 'patients with low back pain (LBP', 'healthy participants as a control group', 'Patients with Low Back Pain']",['Lumbar stabilization exercise programs (LSEPs'],"['RUSI measures for abdominal muscles (transversus abdominis, internal oblique [IO], and external oblique [EO', 'pain', 'RUSI measures', 'pain and disability', 'EO and IO thickness', 'Pain, disability, as well as static (at rest) and dynamic (percent thickness change']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0450355', 'cui_str': '31 (qualifier value)'}, {'cui': 'C0024031', 'cui_str': 'Low Back Ache'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0024090', 'cui_str': 'Lumbar Region'}, {'cui': 'C1293130', 'cui_str': 'Stabilization'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0000739', 'cui_str': 'Abdominal Muscles'}, {'cui': 'C0205102', 'cui_str': 'Internal (qualifier value)'}, {'cui': 'C0205315', 'cui_str': 'Oblique (qualifier value)'}, {'cui': 'C0205101', 'cui_str': 'External (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0441463', 'cui_str': 'Static (qualifier value)'}, {'cui': 'C0443144', 'cui_str': 'At rest (qualifier value)'}, {'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C0439165', 'cui_str': 'Percent (property) (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]",31.0,0.0650564,"RESULTS Patients did not produce systematic changes in RUSI measures relative to controls, even if patients had significant improvement in pain and disability.","[{'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Larivière', 'Affiliation': 'Institut de recherche Robert-Sauvé en santé et en sécurité du travail (IRSST), 505, boul. De Maisonneuve Ouest, Montréal, Québec H3A 3C2, Canada.'}, {'ForeName': 'Sharon M', 'Initials': 'SM', 'LastName': 'Henry', 'Affiliation': 'Department of Rehabilitation Therapy, The University of Vermont Medical Center, Burlington, VT.'}, {'ForeName': 'Dany H', 'Initials': 'DH', 'LastName': 'Gagnon', 'Affiliation': 'School of Rehabilitation, Faculty of Medicine, Université de Montréal, Montréal, Québec, Canada.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Preuss', 'Affiliation': 'School of Physical & Occupational Therapy, McGill University, Montréal, Québec, Canada.'}, {'ForeName': 'Jean-Pierre', 'Initials': 'JP', 'LastName': 'Dumas', 'Affiliation': 'School of Rehabilitation, Faculty of Medicine, Université de Sherbrooke, Sherbrooke, Québec, Canada.'}]","PM & R : the journal of injury, function, and rehabilitation",['10.1002/pmrj.12000'] 1164,31702699,"Effect of Oral Carbohydrate Intake During Labor on the Rate of Instrumental Vaginal Delivery: A Multicenter, Randomized Controlled Trial.","BACKGROUND Carbohydrate intake during physical exercise improves muscle performance and decreases fatigue. We hypothesized that carbohydrate intake during labor, which is a period of significant physical activity, can decrease the instrumental vaginal delivery rate. METHODS In a multicenter, prospective, randomized, controlled trial, healthy adult pregnant women presenting with spontaneous labor were assigned to a ""Carbohydrate"" group (advised to drink 200 mL of apple or grape juice without pulp every 3 hours) or a ""Fasting"" group (water only). The primary outcome was the instrumental vaginal delivery rate. Secondary outcomes included duration of labor, rate of cesarean delivery, evaluation of maternal hunger, thirst, stress, fatigue, and overall feeling during labor by numeric rating scale (0 worst rating to 10 best rating), rate of vomiting, and hospital length of stay. Statistical analysis was performed on an intention-to-treat basis. The primary outcome was tested with the ""Fasting"" group as the reference group. The P values for secondary outcomes were adjusted for multiple comparisons. The differences between groups are reported with 99% confidence interval (CI). RESULTS A total of 3984 women were analyzed (2014 in the Carbohydrate group and 1970 in the Fasting group). There was no difference in the rate of instrumental delivery between the Carbohydrate (21.0%) and the Fasting (22.4%) groups (difference, -1.4%; 99% CI, -4.9 to 2.2). No differences were found between the Carbohydrate and the Fasting groups for the duration of labor (difference, -7 minutes; 99% CI, -25 to 11), the rate of cesarean delivery (difference, -0.3%; 99% CI, -2.4 to 3.0), the rate of vomiting (difference, 2.8%; 99% CI, 0.2-5.7), the degree of self-reported fatigue (difference, 1; 99% CI, 0-2), self-reported hunger (difference, 0; 99% CI, -1 to 1), thirst (difference, 0; 99% CI, -1 to 1), stress (difference, 0; 99% CI, -1 to 1), overall feeling (difference, 0; 99% CI, 0-0), and the length of hospitalization (difference, 0; 99% CI, -1 to 0). CONCLUSIONS Carbohydrate intake during labor did not modify the rate of instrumental vaginal delivery.",2020,"No differences were found between the Carbohydrate and the Fasting groups for the duration of labor (difference, -7 minutes; 99% CI, -25 to 11), the rate of cesarean delivery (difference, -0.3%; 99% CI, -2.4 to 3.0), the rate of vomiting (difference, 2.8%; 99% CI, 0.2-5.7), the degree of self-reported fatigue (difference, 1; 99% CI, 0-2), self-reported hunger (difference, 0; 99% CI, -1 to 1), thirst (difference, 0; 99% CI, -1 to 1), stress (difference, 0; 99% CI, -1 to 1), overall feeling (difference, 0; 99% CI, 0-0), and the length of hospitalization (difference, 0; 99% CI, -1 to 0). ","['A total of 3984 women were analyzed (2014 in the Carbohydrate group and 1970 in the Fasting group', 'healthy adult pregnant women presenting with spontaneous labor']","['Carbohydrate"" group (advised to drink 200 mL of apple or grape juice without pulp every 3 hours) or a ""Fasting"" group (water only', 'Oral Carbohydrate Intake', 'physical exercise']","['degree of self-reported fatigue', 'duration of labor', 'rate of cesarean delivery', 'instrumental vaginal delivery rate', 'self-reported hunger', 'rate of instrumental delivery', 'rate of instrumental vaginal delivery', 'muscle performance and decreases fatigue', 'rate of vomiting', 'length of hospitalization', 'Rate of Instrumental Vaginal Delivery', 'overall feeling', 'duration of labor, rate of cesarean delivery, evaluation of maternal hunger, thirst, stress, fatigue, and overall feeling during labor by numeric rating scale (0 worst rating to 10 best rating), rate of vomiting, and hospital length of stay']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous (qualifier value)'}, {'cui': 'C0022864', 'cui_str': 'Labor, Obstetric'}]","[{'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0452428', 'cui_str': 'Drinks (substance)'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C1095830', 'cui_str': 'Apple'}, {'cui': 'C0452455', 'cui_str': 'Grape juice (substance)'}, {'cui': 'C0585323', 'cui_str': 'Every three hours (qualifier value)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0566679', 'cui_str': 'Duration of labor (observable entity)'}, {'cui': 'C1384674', 'cui_str': 'Deliveries by cesarean (finding)'}, {'cui': 'C0566690', 'cui_str': 'Vaginal delivery (finding)'}, {'cui': 'C0020175', 'cui_str': 'Hunger'}, {'cui': 'C0162209', 'cui_str': 'Instrumental delivery (procedure)'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0039971', 'cui_str': 'Thirst'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0022864', 'cui_str': 'Labor, Obstetric'}, {'cui': 'C0222045'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}]",3984.0,0.23552,"No differences were found between the Carbohydrate and the Fasting groups for the duration of labor (difference, -7 minutes; 99% CI, -25 to 11), the rate of cesarean delivery (difference, -0.3%; 99% CI, -2.4 to 3.0), the rate of vomiting (difference, 2.8%; 99% CI, 0.2-5.7), the degree of self-reported fatigue (difference, 1; 99% CI, 0-2), self-reported hunger (difference, 0; 99% CI, -1 to 1), thirst (difference, 0; 99% CI, -1 to 1), stress (difference, 0; 99% CI, -1 to 1), overall feeling (difference, 0; 99% CI, 0-0), and the length of hospitalization (difference, 0; 99% CI, -1 to 0). ","[{'ForeName': 'Thérèse', 'Initials': 'T', 'LastName': 'Simonet', 'Affiliation': 'From the Department of Anaesthesia and Intensive Care Medicine, Centre Hospitalier Universitaire (CHU) de Caen Normandie, Caen, France.'}, {'ForeName': 'Clément', 'Initials': 'C', 'LastName': 'Gakuba', 'Affiliation': 'From the Department of Anaesthesia and Intensive Care Medicine, Centre Hospitalier Universitaire (CHU) de Caen Normandie, Caen, France.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Desmeulles', 'Affiliation': 'Department of Anaesthesia, Centre Hospitalier (CH) du Cotentin, Cherbourg, France.'}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Corouge', 'Affiliation': 'Department of Anaesthesia and Intensive Care Medicine, CHU Jeanne de Flandre de Lille, Lille, France.'}, {'ForeName': 'Gael', 'Initials': 'G', 'LastName': 'Beucher', 'Affiliation': 'Department of Obstetrics and Gynecology, CHU de Caen Normandie, Caen, France.'}, {'ForeName': 'Rémi', 'Initials': 'R', 'LastName': 'Morello', 'Affiliation': 'Department of Biostatistics, CHU de Caen Normandie, Caen, France.'}, {'ForeName': 'Jean-Louis', 'Initials': 'JL', 'LastName': 'Gérard', 'Affiliation': 'Department of Anaesthesia and Intensive Care Medicine, CHU de Caen Normandie, Caen, France and University of Caen Normandy, Caen, France.'}, {'ForeName': 'Anne Sophie', 'Initials': 'AS', 'LastName': 'Ducloy-Bouthors', 'Affiliation': 'Department of Anaesthesia and Intensive Care Medicine, CHU Jeanne de Flandre de Lille, Lille, France.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Dreyfus', 'Affiliation': 'Department of Obstetrics and Gynecology, CHU de Caen Normandie, Caen, France.'}, {'ForeName': 'Jean-Luc', 'Initials': 'JL', 'LastName': 'Hanouz', 'Affiliation': ""Department of Anaesthesia and Intensive Care Medicine, CHU de Caen Normandie, Caen, France and Equipe d'Accueil (EA4650) University of Caen Normandy, Caen, France.""}]",Anesthesia and analgesia,['10.1213/ANE.0000000000004515'] 1165,31618768,A feasibility trial of Acetic acid-targeted Biopsies versus nontargeted quadrantic biopsies during BArrett's surveillance: the ABBA trial.,"BACKGROUND The aims of this study were to compare neoplasia detection rates for nontargeted biopsies (Seattle protocol) versus acetic acid-targeted biopsies (Portsmouth protocol) during Barrett's surveillance and to explore feasibility, patient/clinician experience, acceptance, and barriers/enablers to study participation and implementation of the acetic acid technique. METHODS This was a mixed-methods feasibility study including a pilot multicenter, randomized, crossover trial with qualitative interviews. Patients under Barrett's surveillance with no history of neoplasia were included. Patients underwent two endoscopies, one with each protocol, 8 weeks apart. Outcomes included recruitment and retention rates, neoplasia yield, and number of biopsies. RESULTS 200 patients were recruited from 6 centers, and 174 (87.0 %) underwent both procedures. Neoplasia prevalence was 4.7 % (9/192). High grade dysplasia and cancer were detected with both protocols. Five low grade dysplasias were detected (two with acetic acid, four with nontargeted biopsies; one lesion was detected with both techniques). A total of 2139 biopsies were taken in the nontargeted arm and 226 in the acetic acid arm. Both patients and clinicians found the acetic acid technique acceptable. Based on these data, a noninferiority, tandem, crossover trial would require an estimated 2828 patients. CONCLUSIONS We demonstrated the feasibility of performing a crossover endoscopy trial in Barrett's surveillance. Low neoplasia yield makes this design necessary and qualitative results demonstrated patient and clinician acceptance. The reduced numbers of biopsies suggest that the acetic acid technique could result in cost savings, providing the lack of missed pathology can be proven in a fully powered definitive trial.",2020,"The reduced numbers of biopsies suggest that the acetic acid technique could result in cost savings, providing the lack of missed pathology can be proven in a fully powered definitive trial.","['A total of 2139 biopsies were taken in the nontargeted arm and 226 in the acetic acid arm', '200 patients were recruited from 6 centers, and 174 (87.0\u200a%) underwent both procedures', ""Patients under Barrett's surveillance with no history of neoplasia were included"", '2828 patients']","['Acetic acid-targeted Biopsies versus nontargeted quadrantic biopsies', 'nontargeted biopsies (Seattle protocol) versus acetic acid-targeted biopsies (Portsmouth protocol']","['neoplasia detection rates', 'cost savings', 'recruitment and retention rates, neoplasia yield, and number of biopsies', 'High grade dysplasia and cancer', 'Neoplasia prevalence']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0766298', 'cui_str': '(methylsulfanyl)acetic acid'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C4517604', 'cui_str': 'One hundred and seventy-four'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0733511', 'cui_str': 'Surveillance (regime/therapy)'}, {'cui': 'C0332122', 'cui_str': 'No history of (contextual qualifier) (qualifier value)'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C0766298', 'cui_str': '(methylsulfanyl)acetic acid'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}]","[{'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0085550', 'cui_str': 'Saving, Cost'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0449807', 'cui_str': 'Number of biopsies (qualifier value)'}, {'cui': 'C1962917', 'cui_str': 'High grade (lymphoma)'}, {'cui': 'C0334044', 'cui_str': 'Dysplasia (morphologic abnormality)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}]",2828.0,0.179255,"The reduced numbers of biopsies suggest that the acetic acid technique could result in cost savings, providing the lack of missed pathology can be proven in a fully powered definitive trial.","[{'ForeName': 'Gaius', 'Initials': 'G', 'LastName': 'Longcroft-Wheaton', 'Affiliation': 'Portsmouth Hospitals NHS Trust, Portsmouth, United Kingdom.'}, {'ForeName': 'Carole', 'Initials': 'C', 'LastName': 'Fogg', 'Affiliation': 'Portsmouth Hospitals NHS Trust, Portsmouth, United Kingdom.'}, {'ForeName': 'Fergus', 'Initials': 'F', 'LastName': 'Chedgy', 'Affiliation': 'Portsmouth Hospitals NHS Trust, Portsmouth, United Kingdom.'}, {'ForeName': 'Kesavan', 'Initials': 'K', 'LastName': 'Kandiah', 'Affiliation': 'Portsmouth Hospitals NHS Trust, Portsmouth, United Kingdom.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Murray', 'Affiliation': 'Portsmouth Hospitals NHS Trust, Portsmouth, United Kingdom.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Dewey', 'Affiliation': 'School of Health Sciences and Social Work, University of Portsmouth, Portsmouth, United Kingdom.'}, {'ForeName': 'Hugh', 'Initials': 'H', 'LastName': 'Barr', 'Affiliation': 'Surgery, Gloucestershire Hospitals NHS Foundation Trust, Cheltenham, United Kingdom.'}, {'ForeName': 'Bernie', 'Initials': 'B', 'LastName': 'Higgins', 'Affiliation': 'Department of Mathematics, University of Portsmouth, Portsmouth, United Kingdom.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Poller', 'Affiliation': 'Portsmouth Hospitals NHS Trust, Portsmouth, United Kingdom.'}, {'ForeName': 'Janusz', 'Initials': 'J', 'LastName': 'Jankowski', 'Affiliation': 'Gastroenterology, University Hospitals of Morcambe Bay NHS Foundation Trust, Lancaster, United Kingdom.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'DeCaestecker', 'Affiliation': 'University Hospitals of Leicester, Leicester, United Kingdom.'}, {'ForeName': 'Pradeep', 'Initials': 'P', 'LastName': 'Bhandari', 'Affiliation': 'Portsmouth Hospitals NHS Trust, Portsmouth, United Kingdom.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Endoscopy,['10.1055/a-1015-6653'] 1166,30785855,The Feasibility of Group Therapeutic Singing Telehealth for Persons with Parkinson's Disease in Rural Iowa.,"Introduction: Group therapeutic singing (GTS) may be an effective treatment for voice and respiratory impairments in persons with Parkinson's disease (PD). However, it remains unknown if GTS can be effectively delivered through telemedicine. Methods: Participants with PD from rural areas were recruited to complete a prerecorded GTS program, once a week for 8 weeks. Voice and respiratory outcome measures were collected 1 week before and 1 week after intervention. Results: Ten participants were enrolled in the study. One participant dropped at week 3. Five participants attended all eight sessions, two participants completed seven sessions, and one participant completed six sessions for 93.75% compliance. Statistical analysis for the data collected from the eight participants enrolled in the study revealed that voice outcome measures improved but did not reach significance. However, respiratory outcome measures significantly improved. Discussion: Results suggest that prerecorded GTS is feasible. Moreover, results are in keeping with results from a previous study using the exact same intervention with an in person therapist. Thus, this pilot work suggests that the use of prerecorded GTS may be a viable treatment option for those with limited access to care.",2020,"INTRODUCTION Group therapeutic singing (GTS) may be an effective treatment for voice and respiratory impairments in persons with Parkinson's disease (PD).","['Ten participants were enrolled in the study', ""Persons with Parkinson's Disease in Rural Iowa"", 'Participants with PD from rural areas', ""persons with Parkinson's disease (PD""]","['Group Therapeutic Singing Telehealth', 'Group therapeutic singing (GTS']",[],"[{'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0030567', 'cui_str': 'Idiopathic Parkinson Disease'}, {'cui': 'C0022037', 'cui_str': 'Iowa'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0234857', 'cui_str': 'Singing'}, {'cui': 'C1328956', 'cui_str': 'eHealth'}]",[],10.0,0.0197032,"INTRODUCTION Group therapeutic singing (GTS) may be an effective treatment for voice and respiratory impairments in persons with Parkinson's disease (PD).","[{'ForeName': 'Elizabeth L', 'Initials': 'EL', 'LastName': 'Stegemöller', 'Affiliation': 'Department of Kinesiology, Iowa State University, Ames, Iowa.'}, {'ForeName': 'Kasandra', 'Initials': 'K', 'LastName': 'Diaz', 'Affiliation': 'Department of Kinesiology, Iowa State University, Ames, Iowa.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Craig', 'Affiliation': 'Department of Kinesiology, Iowa State University, Ames, Iowa.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Brown', 'Affiliation': 'College of Human Science Extension and Outreach, Iowa State University, Ames, Iowa.'}]",Telemedicine journal and e-health : the official journal of the American Telemedicine Association,['10.1089/tmj.2018.0315'] 1167,31875648,Formative Usability Testing Reduces Severe Blood Product Ordering Errors.,"BACKGROUND Medical errors in blood product orders and administration are common, especially for pediatric patients. A failure modes and effects analysis in our health care system indicated high risk from the electronic blood ordering process. OBJECTIVES There are two objectives of this study as follows:(1) To describe differences in the design of the original blood product orders and order sets in the system (original design), new orders and order sets designed by expert committee (DEC), and a third-version developed through user-centered design (UCD).(2) To compare the number and type of ordering errors, task completion rates, time on task, and user preferences between the original design and that developed via UCD. METHODS A multidisciplinary expert committee proposed adjustments to existing blood product order sets resulting in the DEC order set. When that order set was tested with front-line users, persistent failure modes were detected, so orders and order sets were redesigned again via formative usability testing. Front-line users in their native clinical workspaces were observed ordering blood in realistic simulated scenarios using a think-aloud protocol. Iterative adjustments were made between participants. In summative testing, participants were randomized to use the original design or UCD for five simulated scenarios. We evaluated differences in ordering errors, time on task, and users' design preference with two-sample t -tests. RESULTS Formative usability testing with 27 providers from seven specialties led to 18 changes made to the DEC to produce the UCD. In summative testing, error-free task completion for the original design was 36%, which increased to 66% in UCD (30%, 95% confidence interval [CI]: 3.9-57%; p  = 0.03). Time on task did not vary significantly. CONCLUSION UCD led to substantially different blood product orders and order sets than DEC. Users made fewer errors when ordering blood products for pediatric patients in simulated scenarios when using the UCD orders and order sets compared with the original design.",2019,Users made fewer errors when ordering blood products for pediatric patients in simulated scenarios when using the UCD orders and order sets compared with the original design.,['pediatric patients'],[],"['number and type of ordering errors, task completion rates, time on task, and user preferences', ""ordering errors, time on task, and users' design preference""]","[{'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]",[],"[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C4284072', 'cui_str': 'Order (record artifact)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0558295', 'cui_str': 'Preferences (qualifier value)'}]",,0.0820362,Users made fewer errors when ordering blood products for pediatric patients in simulated scenarios when using the UCD orders and order sets compared with the original design.,"[{'ForeName': 'Evan W', 'Initials': 'EW', 'LastName': 'Orenstein', 'Affiliation': 'Department of Pediatrics, Emory University School of Medicine, Atlanta, Georgia, United States.'}, {'ForeName': 'Jeanne', 'Initials': 'J', 'LastName': 'Boudreaux', 'Affiliation': 'Department of Pediatrics, Emory University School of Medicine, Atlanta, Georgia, United States.'}, {'ForeName': 'Margo', 'Initials': 'M', 'LastName': 'Rollins', 'Affiliation': ""Aflac Cancer and Blood Disorders Program, Children's Healthcare of Atlanta, Atlanta, Georgia, United States.""}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Jones', 'Affiliation': ""Aflac Cancer and Blood Disorders Program, Children's Healthcare of Atlanta, Atlanta, Georgia, United States.""}, {'ForeName': 'Christy', 'Initials': 'C', 'LastName': 'Bryant', 'Affiliation': ""Information Services and Technology, Children's Healthcare of Atlanta, Atlanta, Georgia, United States.""}, {'ForeName': 'Dean', 'Initials': 'D', 'LastName': 'Karavite', 'Affiliation': ""Department of Biomedical and Health Informatics, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States.""}, {'ForeName': 'Naveen', 'Initials': 'N', 'LastName': 'Muthu', 'Affiliation': ""Department of Biomedical and Health Informatics, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States.""}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Hike', 'Affiliation': ""Information Services and Technology, Children's Healthcare of Atlanta, Atlanta, Georgia, United States.""}, {'ForeName': 'Herb', 'Initials': 'H', 'LastName': 'Williams', 'Affiliation': ""Information Services and Technology, Children's Healthcare of Atlanta, Atlanta, Georgia, United States.""}, {'ForeName': 'Tania', 'Initials': 'T', 'LastName': 'Kilgore', 'Affiliation': ""Information Services and Technology, Children's Healthcare of Atlanta, Atlanta, Georgia, United States.""}, {'ForeName': 'Alexis B', 'Initials': 'AB', 'LastName': 'Carter', 'Affiliation': ""Department of Pathology and Laboratory Medicine, Children's Healthcare of Atlanta, Atlanta, Georgia, United States.""}, {'ForeName': 'Cassandra D', 'Initials': 'CD', 'LastName': 'Josephson', 'Affiliation': 'Department of Pediatrics, Emory University School of Medicine, Atlanta, Georgia, United States.'}]",Applied clinical informatics,['10.1055/s-0039-3402714'] 1168,31623572,"Ultrasound-guided quadratus lumborum block for postoperative pain control in patients undergoing unilateral inguinal hernia repair, a comparative study between two approaches.","BACKGROUND Early postoperative ambulation and reduction of hospital stay necessitate efficient postoperative analgesia. Quadrates Lumborum Block (QLB) has been described to provide adequate postoperative analgesia after abdominal surgery. This randomized comparative trial was designed to compare the duration of analgesia provided by two different QLB approaches; the posterior QLB (QLB-2) and transmuscular QLB (QLB-3) in patients undergoing surgical repair of unilateral inguinal hernia. METHODS Forty patients, aged from 18 to 50 years, ASA physical status I or II, scheduled for unilateral inguinal hernia repair were enrolled. At the end of the surgical procedure and before recovery from general anesthesia, Patients were randomly assigned into two groups to receive either posterior QLB (Group QLB-2) or transmuscular QLB (Group QLB-3) using 20 ml 0.25% bupivacaine. Duration of analgesia, postoperative VAS and postoperative opioid consumption were recorded. RESULTS Duration of block was significantly longer in QLB-3 group when compared to QLB-2 group (20.1 + 6.2 h versus 12.0 + 4.8 respectively) with P value of < 0.001. A statistically significant lower VAS score was recorded in QLB-3 group immediately and 12 h postoperative. QLB-3 group showed a statistically significant delayed time of first analgesic request and less postoperative morphine consumption with P value of < 0.001 and 0.001 respectively. CONCLUSIONS Ultrasound guided postsurgical transmuscular approach of QLB (QLB-3) using 20 ml 0.25% bupivacaine produces more postoperative analgesic effect and less postoperative opioid consumption when compared to posterior QLB approach (QLB-2) in patients underwent unilateral inguinal hernia repair under general anesthesia. TRIAL REGISTRATION ClinicalTrials.gov identifier: NCT03526731 - on 16 May 2018.",2019,"QLB-3 group showed a statistically significant delayed time of first analgesic request and less postoperative morphine consumption with P value of < 0.001 and 0.001 respectively. ","['Forty patients, aged from 18 to 50\u2009years, ASA physical status I or II, scheduled for unilateral inguinal hernia repair were enrolled', 'patients undergoing unilateral inguinal hernia repair', 'patients underwent unilateral inguinal hernia repair under general anesthesia', 'patients undergoing surgical repair of unilateral inguinal hernia']","['Ultrasound-guided quadratus lumborum block', 'QLB-3', 'posterior QLB (Group QLB-2) or transmuscular QLB (Group QLB-3) using 20\u2009ml 0.25% bupivacaine', 'QLB-2', 'posterior QLB (QLB-2) and transmuscular QLB (QLB-3', 'Quadrates Lumborum Block (QLB', 'bupivacaine', 'posterior QLB approach (QLB-2']","['delayed time of first analgesic request and less postoperative morphine consumption', 'postoperative opioid consumption', 'postoperative analgesic effect', 'Duration of analgesia, postoperative VAS and postoperative opioid consumption', 'Duration of block', 'VAS score']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C0021446', 'cui_str': 'Repair of inguinal hernia (procedure)'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0374711', 'cui_str': 'Surgical repair (procedure)'}, {'cui': 'C0019294', 'cui_str': 'Hernia, Inguinal'}]","[{'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4517443', 'cui_str': '0.25 (qualifier value)'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}]","[{'cui': 'C0522486', 'cui_str': 'Delay time (qualifier value)'}, {'cui': 'C0420259', 'cui_str': 'Analgesics requested (finding)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0948482', 'cui_str': 'Analgesic effect'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",40.0,0.0875008,"QLB-3 group showed a statistically significant delayed time of first analgesic request and less postoperative morphine consumption with P value of < 0.001 and 0.001 respectively. ","[{'ForeName': 'Abeer', 'Initials': 'A', 'LastName': 'Ahmed', 'Affiliation': 'Department of Anesthesiology, Surgical ICU and pain management, Kasr Alainy Faculty of Medicine, Cairo University, 01 El Sarayah street, El Manyal, Cairo, 11559, Egypt. abeer_ahmed@kasralainy.edu.eg.'}, {'ForeName': 'Maher', 'Initials': 'M', 'LastName': 'Fawzy', 'Affiliation': 'Department of Anesthesiology, Surgical ICU and pain management, Kasr Alainy Faculty of Medicine, Cairo University, 01 El Sarayah street, El Manyal, Cairo, 11559, Egypt.'}, {'ForeName': 'Mohamed A R', 'Initials': 'MAR', 'LastName': 'Nasr', 'Affiliation': 'Department of Anesthesiology, Surgical ICU and pain management, Kasr Alainy Faculty of Medicine, Cairo University, 01 El Sarayah street, El Manyal, Cairo, 11559, Egypt.'}, {'ForeName': 'Ayman M', 'Initials': 'AM', 'LastName': 'Hussam', 'Affiliation': 'Department of Anesthesiology, Surgical ICU and pain management, Kasr Alainy Faculty of Medicine, Cairo University, 01 El Sarayah street, El Manyal, Cairo, 11559, Egypt.'}, {'ForeName': 'Eman', 'Initials': 'E', 'LastName': 'Fouad', 'Affiliation': 'Department of Anesthesiology, Surgical ICU and pain management, Kasr Alainy Faculty of Medicine, Cairo University, 01 El Sarayah street, El Manyal, Cairo, 11559, Egypt.'}, {'ForeName': 'Hesham', 'Initials': 'H', 'LastName': 'Aboeldahb', 'Affiliation': 'Department of Anesthesiology, Surgical ICU and pain management, Kasr Alainy Faculty of Medicine, Cairo University, 01 El Sarayah street, El Manyal, Cairo, 11559, Egypt.'}, {'ForeName': 'Dalia', 'Initials': 'D', 'LastName': 'Saad', 'Affiliation': 'Department of Anesthesiology, Surgical ICU and pain management, Kasr Alainy Faculty of Medicine, Cairo University, 01 El Sarayah street, El Manyal, Cairo, 11559, Egypt.'}, {'ForeName': 'Safinaz', 'Initials': 'S', 'LastName': 'Osman', 'Affiliation': 'Department of Anesthesiology, Surgical ICU and pain management, Kasr Alainy Faculty of Medicine, Cairo University, 01 El Sarayah street, El Manyal, Cairo, 11559, Egypt.'}, {'ForeName': 'Rania Samir', 'Initials': 'RS', 'LastName': 'Fahmy', 'Affiliation': 'Department of Anesthesiology, Surgical ICU and pain management, Kasr Alainy Faculty of Medicine, Cairo University, 01 El Sarayah street, El Manyal, Cairo, 11559, Egypt.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Farid', 'Affiliation': 'Department of Anesthesiology, Surgical ICU and pain management, Kasr Alainy Faculty of Medicine, Cairo University, 01 El Sarayah street, El Manyal, Cairo, 11559, Egypt.'}, {'ForeName': 'Mohsen M', 'Initials': 'MM', 'LastName': 'Waheb', 'Affiliation': 'Department of Anesthesiology, Surgical ICU and pain management, Kasr Alainy Faculty of Medicine, Cairo University, 01 El Sarayah street, El Manyal, Cairo, 11559, Egypt.'}]",BMC anesthesiology,['10.1186/s12871-019-0862-z'] 1169,31729825,Primary baerveldt versus trabeculectomy study after 5 years of follow-up.,"PURPOSE Although the Baerveldt glaucoma implant (BGI) initially was reserved for refractory glaucoma, its role in the surgical management of glaucoma has shifted towards a primary treatment choice. We performed a randomized prospective study to compare BGI surgery and trabeculectomy (TE) in patients without previous ocular surgery. METHODS We included 119 glaucoma patients without previous ocular surgery. One eye of each subject was randomized to either a BGI or TE. Follow-up visits were at 1 day, 2 weeks, 6 weeks, 3 months, 6 months and 1, 2, 3, 4 and 5 years postoperatively. Primary outcomes were intraocular pressure (IOP) and failure rate. Secondary outcomes were medication, anterior chamber laser flare value and complications. RESULTS After 5 years, an IOP of 12.7 ± 3.9 mmHg (mean ± SD) was achieved in the TE group and 12.9 ± 3.9 mmHg in the BGI group. We found no statistically significant difference in failure rate between the groups (p = 0.72). More BGI patients needed additional medication to control their IOP (85%; 1.9 ± 1.2 types of glaucoma medication) compared to the TE patients (57%; 0.5 ± 0.9 types of glaucoma medication). Diplopia was significantly more present in the BGI group than in the TE group (27% versus 4%; p < 0.001). The self-limiting complication rate was similar in both groups. CONCLUSIONS Our study demonstrates that, in the long term, the final IOP and failure rate are similar after TE and BGI surgery. However, the need for additional medication after BGI surgery is higher than after TE. Also, the increased risk of developing diplopia after BGI surgery must be taken into consideration.",2020,We found no statistically significant difference in failure rate between the groups (p = 0.72).,"['patients without previous ocular surgery', '119 glaucoma patients without previous ocular surgery']","['BGI or TE', 'BGI surgery and trabeculectomy (TE']","['medication, anterior chamber laser flare value and complications', 'Diplopia', 'self-limiting complication rate', 'intraocular pressure (IOP) and failure rate', 'failure rate', 'final IOP and failure rate']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C1705869', 'cui_str': 'Ophthalmic surgery (qualifier value)'}, {'cui': 'C2242746', 'cui_str': 'Glaucoma (SMQ)'}]","[{'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C3263686', 'cui_str': 'Ocular trabeculectomy'}]","[{'cui': 'C0003151', 'cui_str': 'Anterior Chamber'}, {'cui': 'C0023089', 'cui_str': 'Lasers'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0012569', 'cui_str': 'Double Vision'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0439801', 'cui_str': 'Limited (qualifier value)'}, {'cui': 'C0021888', 'cui_str': 'Ocular Tension'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}]",119.0,0.0647951,We found no statistically significant difference in failure rate between the groups (p = 0.72).,"[{'ForeName': 'Esma', 'Initials': 'E', 'LastName': 'Islamaj', 'Affiliation': 'Rotterdam Eye Hospital, Rotterdam Ophthalmic Institute, Rotterdam, The Netherlands.'}, {'ForeName': 'René J', 'Initials': 'RJ', 'LastName': 'Wubbels', 'Affiliation': 'Rotterdam Eye Hospital, Rotterdam Ophthalmic Institute, Rotterdam, The Netherlands.'}, {'ForeName': 'Peter W T', 'Initials': 'PWT', 'LastName': 'de Waard', 'Affiliation': 'Glaucoma Department, Rotterdam Eye Hospital, Rotterdam, The Netherlands.'}]",Acta ophthalmologica,['10.1111/aos.14265'] 1170,31679509,Variable versus fixed-rate infusion of phenylephrine during cesarean delivery: a randomized controlled trial.,"BACKGROUND Phenylephrine is the most commonly used vasopressor for prophylaxis against maternal hypotension during cesarean delivery; however, the best regimen for its administration is not well established. Although variable infusion protocols had been suggested for phenylephrine infusion, evidence-based evaluation of variable infusion regimens are lacking. The aim of this work is to compare variable infusion, fixed on-and-off infusion, and intermittent boluses of phenylephrine for prophylaxis against maternal hypotension during cesarean delivery. METHODS A randomized controlled study was conducted, including full-term pregnant women scheduled for elective cesarean delivery. Participants were divided into three groups which received phenylephrine by either intermittent boluses (1.5 mcg/Kg phenylephrine), fixed on-and-off infusion (with a dose of 0.75 mcg/Kg/min), or variable infusion (with a starting dose of 0.75 mcg/Kg/min). The three groups were compared with regard to frequency of: maternal hypotension (primary outcome), second episode hypotension, reactive hypertension, and bradycardia. Other outcomes included heart rate, systolic blood pressure, physician interventions, and neonatal outcomes. RESULTS Two-hundred and seventeen mothers were available for final analysis. The 2 infusion groups showed less incidence of maternal hypotension {26/70 (37%), 22/71 (31%), and (51/76 (67%)} and higher incidence of reactive hypertension compared to the intermittent boluses group without significant differences between the two former groups. The number of physician interventions was highest in the variable infusion group compared to the other two groups. The intermittent boluses group showed lower systolic blood pressure and higher heart rate compared to the two infusion groups; whilst the two later groups were comparable. CONCLUSION Both phenylephrine infusion regimens equally prevented maternal hypotension during cesarean delivery compared to intermittent boluses regimen. Due to higher number of physician interventions in the variable infusion regimen, the current recommendations which favor this regimen over fixed infusion regimen might need re-evaluation.",2019,"The intermittent boluses group showed lower systolic blood pressure and higher heart rate compared to the two infusion groups; whilst the two later groups were comparable. ","['full-term pregnant women scheduled for elective cesarean delivery', 'Two-hundred and seventeen mothers']","['phenylephrine by either intermittent boluses (1.5 mcg/Kg phenylephrine', 'Phenylephrine', 'phenylephrine']","['systolic blood pressure and higher heart rate', 'maternal hypotension', 'heart rate, systolic blood pressure, physician interventions, and neonatal outcomes', 'number of physician interventions', 'reactive hypertension', 'maternal hypotension (primary outcome), second episode hypotension, reactive hypertension, and bradycardia', 'incidence of maternal hypotension ']","[{'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0473296', 'cui_str': 'Elective cesarean section'}, {'cui': 'C4517646', 'cui_str': '217'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}]","[{'cui': 'C0031469', 'cui_str': 'Phenylephrine'}, {'cui': 'C1301695', 'cui_str': 'Intermittent bolus (qualifier value)'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C1627892', 'cui_str': 'ng/g'}]","[{'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0020649', 'cui_str': 'Blood Pressure, Low'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0205332', 'cui_str': 'Reactive (qualifier value)'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0428977', 'cui_str': 'Bradyarrhythmia'}, {'cui': 'C0220856', 'cui_str': 'incidence'}]",217.0,0.0908121,"The intermittent boluses group showed lower systolic blood pressure and higher heart rate compared to the two infusion groups; whilst the two later groups were comparable. ","[{'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Hasanin', 'Affiliation': 'Department of anesthesia and critical care medicine, Cairo university, Cairo, Egypt. ahmedmohamedhasanin@gmail.com.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Habib', 'Affiliation': 'Department of anesthesia and critical care medicine, Cairo university, Cairo, Egypt.'}, {'ForeName': 'Yaser', 'Initials': 'Y', 'LastName': 'Abdelwahab', 'Affiliation': 'Department of anesthesia and critical care medicine, Cairo university, Cairo, Egypt.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Elsayad', 'Affiliation': 'Department of anesthesia and critical care medicine, Cairo university, Cairo, Egypt.'}, {'ForeName': 'Maha', 'Initials': 'M', 'LastName': 'Mostafa', 'Affiliation': 'Department of anesthesia and critical care medicine, Cairo university, Cairo, Egypt.'}, {'ForeName': 'Marwa', 'Initials': 'M', 'LastName': 'Zayed', 'Affiliation': 'Department of anesthesia and critical care medicine, Cairo university, Cairo, Egypt.'}, {'ForeName': 'Mohamed Maher', 'Initials': 'MM', 'LastName': 'Kamel', 'Affiliation': 'Department of anesthesia and critical care medicine, Cairo university, Cairo, Egypt.'}, {'ForeName': 'Kareem', 'Initials': 'K', 'LastName': 'Hussein', 'Affiliation': 'Department of anesthesia and critical care medicine, Cairo university, Cairo, Egypt.'}, {'ForeName': 'Sherin', 'Initials': 'S', 'LastName': 'Refaat', 'Affiliation': 'Department of anesthesia and critical care medicine, Cairo university, Cairo, Egypt.'}, {'ForeName': 'Ahmed Y', 'Initials': 'AY', 'LastName': 'Fouda', 'Affiliation': 'Department of anesthesia and critical care medicine, Ain Shams university, Cairo, Egypt.'}, {'ForeName': 'Ahmed A', 'Initials': 'AA', 'LastName': 'Wali', 'Affiliation': 'Department of obstetrics and gynecology, Cairo university, Cairo, Egypt.'}, {'ForeName': 'Khaled A', 'Initials': 'KA', 'LastName': 'Elshafaei', 'Affiliation': 'Department of anesthesia and critical care medicine, Cairo university, Cairo, Egypt.'}, {'ForeName': 'Doaa', 'Initials': 'D', 'LastName': 'Mahmoud', 'Affiliation': 'Department of obstetrics and gynecology, Cairo university, Cairo, Egypt.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Amin', 'Affiliation': 'Department of anesthesia and critical care medicine, Cairo university, Cairo, Egypt.'}]",BMC anesthesiology,['10.1186/s12871-019-0879-3'] 1171,31701891,"Safety and efficacy of sphenopalatine ganglion stimulation for chronic cluster headache: a double-blind, randomised controlled trial.","BACKGROUND Chronic cluster headache is the most disabling form of cluster headache. The mainstay of treatment is attack prevention, but the available management options have little efficacy and are associated with substantial side-effects. In this study, we aimed to assess the safety and efficacy of sphenopalatine ganglion stimulation for treatment of chronic cluster headache. METHODS We did a randomised, sham-controlled, parallel group, double-blind, safety and efficacy study at 21 headache centres in the USA. We recruited patients aged 22 years or older with chronic cluster headache, who reported a minimum of four cluster headache attacks per week that were unsuccessfully controlled by preventive treatments. Participants were randomly assigned (1:1) via an online adaptive randomisation procedure to either stimulation of the sphenopalatine ganglion or a sham control that delivered a cutaneous electrical stimulation. Patients and the clinical evaluator and surgeon were masked to group assignment. The primary efficacy endpoint, which was analysed with weighted generalised estimated equation logistic regression models, was the difference between groups in the proportion of stimulation-treated ipsilateral cluster attacks for which relief from pain was achieved 15 min after the start of stimulation without the use of acute drugs before that timepoint. Efficacy analyses were done in all patients who were implanted with a device and provided data for at least one treated attack during the 4-week experimental phase. Safety was assessed in all patients undergoing an implantation procedure up to the end of the open-label phase of the study, which followed the experimental phase. This trial is registered with ClinicalTrials.gov, number NCT02168764. FINDINGS Between July 9, 2014, and Feb 14, 2017, 93 patients were enrolled and randomly assigned, 45 to the sphenopalatine ganglion stimulation group and 48 to the control group. 36 patients in the sphenopalatine ganglion stimulation group and 40 in the control group had at least one attack during the experimental phase and were included in efficacy analyses. The proportion of attacks for which pain relief was experienced at 15 min was 62·46% (95% CI 49·15-74·12) in the sphenopalatine ganglion stimulation group versus 38·87% (28·60-50·25) in the control group (odds ratio 2·62 [95% CI 1·28-5·34]; p=0·008). Nine serious adverse events were reported by the end of the open-label phase. Three of these serious adverse events were related to the implantation procedure (aspiration during intubation, nausea and vomiting, and venous injury or compromise). A fourth serious adverse event was an infection that was attributed to both the stimulation device and the implantation procedure. The other five serious adverse events were unrelated. There were no unanticipated serious adverse events. INTERPRETATION Sphenopalatine ganglion stimulation seems efficacious and is well tolerated, and potentially offers an alternative approach to the treatment of chronic cluster headache. Further research is need to clarify its place in clinical practice. FUNDING Autonomic Technologies.",2019,36 patients in the sphenopalatine ganglion stimulation group and 40 in the control group had at least one attack during the experimental phase and were included in efficacy analyses.,"['Between July 9, 2014, and Feb 14, 2017, 93 patients were enrolled and randomly assigned, 45 to the', 'chronic cluster headache', '21 headache centres in the USA', 'patients aged 22 years or older with chronic cluster headache, who reported a minimum of four cluster headache attacks per week that were unsuccessfully controlled by preventive treatments', '36 patients in the']","['sphenopalatine ganglion stimulation', 'online adaptive randomisation procedure to either stimulation of the sphenopalatine ganglion or a sham control that delivered a cutaneous electrical stimulation']","['Safety', 'Safety and efficacy', 'nausea and vomiting, and venous injury or compromise', 'Nine serious adverse events', 'proportion of stimulation-treated ipsilateral cluster attacks for which relief from pain', 'safety and efficacy', 'proportion of attacks for which pain relief']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0009088', 'cui_str': 'Neuralgic Migraine'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C1304680', 'cui_str': 'Attack (finding)'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0332298', 'cui_str': 'Controlled by (attribute)'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}]","[{'cui': 'C0229062', 'cui_str': 'Pterygopalatine Ganglia'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C4521174', 'cui_str': 'Cutaneous'}, {'cui': 'C0013786', 'cui_str': 'Electrical Stimulation'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting (disorder)'}, {'cui': 'C0340770', 'cui_str': 'Injury of vein (disorder)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0441989', 'cui_str': 'Ipsilateral (qualifier value)'}, {'cui': 'C1304680', 'cui_str': 'Attack (finding)'}, {'cui': 'C1301676', 'cui_str': 'Relieves (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0451615', 'cui_str': 'Pain relief (procedure)'}]",93.0,0.241285,36 patients in the sphenopalatine ganglion stimulation group and 40 in the control group had at least one attack during the experimental phase and were included in efficacy analyses.,"[{'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Goadsby', 'Affiliation': ""National Institute for Health Research-Wellcome Trust King's Clinical Research Facility and South London and the Maudsley Biomedical Research Centre, King's College London, London, UK. Electronic address: peter.goadsby@kcl.ac.uk.""}, {'ForeName': 'Soma', 'Initials': 'S', 'LastName': 'Sahai-Srivastava', 'Affiliation': 'Keck School of Medicine of University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Eric J', 'Initials': 'EJ', 'LastName': 'Kezirian', 'Affiliation': 'Keck School of Medicine of University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Anne H', 'Initials': 'AH', 'LastName': 'Calhoun', 'Affiliation': 'Carolina Headache Institute, Durham, NC, USA.'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Matthews', 'Affiliation': 'Carolinas HealthCare System, Charlotte, NC, USA.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'McAllister', 'Affiliation': 'New England Institute for Neurology and Headache, Stamford, CT, USA.'}, {'ForeName': 'Peter D', 'Initials': 'PD', 'LastName': 'Costantino', 'Affiliation': 'New York Head and Neck Institute, Northwell Health System, New York, NY, USA.'}, {'ForeName': 'Deborah I', 'Initials': 'DI', 'LastName': 'Friedman', 'Affiliation': 'Department of Neurology and Neurotherapeutics, University of Texas Southwestern Medical Center, Dallas, TX, USA; Department of Ophthalmology, University of Texas Southwestern Medical Center, Dallas, TX, USA; Headache and Facial Pain Program, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Zuniga', 'Affiliation': 'Department of Neurology and Neurotherapeutics, University of Texas Southwestern Medical Center, Dallas, TX, USA; Department of Surgery, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Laszlo L', 'Initials': 'LL', 'LastName': 'Mechtler', 'Affiliation': 'Dent Headache Center, Dent Neurologic Institute, Buffalo, NY, USA.'}, {'ForeName': 'Saurin R', 'Initials': 'SR', 'LastName': 'Popat', 'Affiliation': 'Department of Otolaryngology-Head & Neck Surgery, Jacobs School of Medicine and Biomedical Sciences, University of Buffalo, Buffalo, NY, USA.'}, {'ForeName': 'Ali R', 'Initials': 'AR', 'LastName': 'Rezai', 'Affiliation': 'Rockefeller Neuroscience Institute, West Virginia University School of Medicine, Morgantown, WV, USA.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Dodick', 'Affiliation': 'Department of Neurology, Mayo Clinic, Scottsdale, AZ, USA.'}]",The Lancet. Neurology,['10.1016/S1474-4422(19)30322-9'] 1172,31736269,Aqueous humour cytokine changes during a loading phase of intravitreal ranibizumab or dexamethasone implant in diabetic macular oedema.,"PURPOSE To determine the effect of intravitreal ranibizumab and a dexamethasone implant on aqueous humour cytokine, protein and enzyme levels and to correlate findings to morphologic and functional changes. METHODS In a prospective, randomized, controlled, double-blind study, patients with clinically significant diabetic macular oedema (CSME) were randomly allocated to receive either monthly intravitreal injections of ranibizumab (Lucentis, Novartis Pharma) or a single dexamethasone implant (Ozurdex, Pharm-Allergan) at baseline (BL). Aqueous humour samples were collected at BL and weeks 2, 8 and 20. RESULTS The study included 18 eyes of 18 patients. In the dexamethasone implant group, soluble intercellular adhesion molecule 1 (sICAM-1) (weeks 2 and 8), CXCL9/monokine induced by gamma interferon (MIG) (weeks 2 and 8), soluble vascular cell adhesion protein 1 (sVCAM-1) (weeks 2 and 8) and monocyte chemo-attractant protein 1 (MCP-1) (week 2) levels were significantly decreased compared with baseline. In the ranibizumab group, placental growth factor (PIGF) (week 2) and vascular endothelial growth factor (VEGF) (week 2 and 8) levels were significantly decreased compared with baseline. No significant changes in central retinal thickness (CRT) or Early Treatment Diabetic Retinopathy Study (ETDRS) best corrected visual acuity (BCVA) were observed in the Ozurdex group at any time-points. ETDRS scores significantly increased at week 20 (84.88 ± 8.88 letters) compared with baseline (74.78 ± 14.85 letters), and the CRT decreased significantly at week 4 (381.00 ± 114.64 μm) compared with baseline (440 ± 144 μm) in the Lucentis group. CONCLUSION The dexamethasone implant affected the aqueous cytokines and proteins MCP-1, sICAM-1, sVCAM-1 and MIG, whereas ranibizumab treatments reduced VEGF and PIGF levels. Morphological changes may diverge from cytokine changes. Results may indicate a rationale for a combination therapy for CSME using both agents, the dexamethasone implant and repeatedly administered ranibizumab injections.",2020,"In the dexamethasone implant group, soluble intercellular adhesion molecule 1 (sICAM-1) (weeks 2 and 8), CXCL9/monokine induced by gamma interferon (MIG) (weeks 2 and 8), soluble vascular cell adhesion protein 1","['diabetic macular oedema', '144\xa0μm) in the Lucentis group', '18 eyes of 18 patients', 'patients with clinically significant diabetic macular oedema (CSME']","['ranibizumab', 'ranibizumab (Lucentis, Novartis Pharma) or a single dexamethasone implant (Ozurdex, Pharm-Allergan) at baseline (BL', 'dexamethasone', 'dexamethasone implant', 'intravitreal ranibizumab']","['aqueous humour cytokine, protein and enzyme levels', 'placental growth factor (PIGF) (week 2) and vascular endothelial growth factor (VEGF', 'aqueous cytokines and proteins MCP-1, sICAM-1, sVCAM-1 and MIG', 'CRT', 'ETDRS scores', 'central retinal thickness (CRT) or Early Treatment Diabetic Retinopathy Study (ETDRS) best corrected visual acuity (BCVA', 'soluble vascular cell adhesion protein 1', 'VEGF and PIGF levels', 'soluble intercellular adhesion molecule 1 (sICAM-1']","[{'cui': 'C0730285', 'cui_str': 'Diabetic macular edema'}, {'cui': 'C1721374', 'cui_str': 'Lucentis'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0730284', 'cui_str': 'Clinically significant macular edema (disorder)'}]","[{'cui': 'C1566537', 'cui_str': 'ranibizumab'}, {'cui': 'C1721374', 'cui_str': 'Lucentis'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C2828363', 'cui_str': 'Implant'}, {'cui': 'C2702456', 'cui_str': 'Ozurdex'}]","[{'cui': 'C0003662', 'cui_str': 'Intraocular Fluid'}, {'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C1287349', 'cui_str': 'Finding of enzyme level (finding)'}, {'cui': 'C0018284', 'cui_str': 'Growth factor (substance)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0078058', 'cui_str': 'Vascular Endothelial Growth Factor A'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0035331', 'cui_str': 'Retinal'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0011884', 'cui_str': 'Diabetic Retinopathy'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1690532', 'cui_str': 'Best corrected visual acuity'}, {'cui': 'C0007577', 'cui_str': 'Cell Adhesion'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0063695', 'cui_str': 'CD54 Antigens'}]",,0.0854803,"In the dexamethasone implant group, soluble intercellular adhesion molecule 1 (sICAM-1) (weeks 2 and 8), CXCL9/monokine induced by gamma interferon (MIG) (weeks 2 and 8), soluble vascular cell adhesion protein 1","[{'ForeName': 'Dominika', 'Initials': 'D', 'LastName': 'Podkowinski', 'Affiliation': 'Department of Ophthalmology and Optometry, Kepler University Clinic, Linz, Austria.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Orlowski-Wimmer', 'Affiliation': 'Department of Ophthalmology and Optometry, Kepler University Clinic, Linz, Austria.'}, {'ForeName': 'Gerhard', 'Initials': 'G', 'LastName': 'Zlabinger', 'Affiliation': 'Division of Clinical and Experimental Immunology, Institute of Immunology, Medical University Vienna, Vienna, Austria.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Pollreisz', 'Affiliation': 'Department of Ophthalmology and Optometry, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Anna-Sophie', 'Initials': 'AS', 'LastName': 'Mursch-Edlmayr', 'Affiliation': 'Department of Ophthalmology and Optometry, Kepler University Clinic, Linz, Austria.'}, {'ForeName': 'Siegfried', 'Initials': 'S', 'LastName': 'Mariacher', 'Affiliation': 'Department of Ophthalmology and Optometry, Kepler University Clinic, Linz, Austria.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Ring', 'Affiliation': 'Center for Medical Research, Johannes Kepler University, Linz, Austria.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Bolz', 'Affiliation': 'Department of Ophthalmology and Optometry, Kepler University Clinic, Linz, Austria.'}]",Acta ophthalmologica,['10.1111/aos.14297'] 1173,30793786,Optimising the two-stage randomised trial design when some participants are indifferent in their treatment preferences.,"Outcomes in a clinical trial can be affected by any underlying preferences that its participants have for the treatments under comparison and by whether they actually receive their preferred treatment. These effects cannot be evaluated in standard trial designs but are estimable in the alternative two-stage randomised trial design, in which some patients can choose their treatment, while the rest are randomly assigned. We have previously shown that, when all two-stage trial participants have a preferred treatment, the preference effects can be evaluated, in addition to the usual direct effect of treatment. We also determined criteria by which to optimise how many participants should be given a choice of treatment vs being randomised. More recently, we extended our methodology to allow for participants who are unable or unwilling to express a treatment preference if they are assigned to the choice group. In this paper, we show how to optimise the two-stage design when some participants are undecided about their treatment. We demonstrate that the undecided group should be regarded as distinct in the analysis, to obtain valid estimates of the preference effects. We derive the optimal proportion of participants who should be offered a choice of treatment, which in many cases will be close to 50%. More generally, the optima depend on the preference rates for treatments and the proportion of undecided participants, and the parameters of primary interest. We discuss some advantages and disadvantages of the two-stage trial design in this situation and describe a practical example.",2019,"We derive the optimal proportion of participants who should be offered a choice of treatment, which in many cases will be close to 50%.",['participants who are unable or unwilling to express a treatment preference if they are assigned to the choice group'],[],[],"[{'cui': 'C1299582', 'cui_str': 'Unable'}, {'cui': 'C0558080', 'cui_str': 'Unwilling (finding)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0558295', 'cui_str': 'Preferences (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]",[],[],,0.104798,"We derive the optimal proportion of participants who should be offered a choice of treatment, which in many cases will be close to 50%.","[{'ForeName': 'Stephen D', 'Initials': 'SD', 'LastName': 'Walter', 'Affiliation': 'Department of Health Research Methods, Evidence, and Impact, McMaster University, Hamilton, Canada.'}, {'ForeName': 'Robin M', 'Initials': 'RM', 'LastName': 'Turner', 'Affiliation': 'Biostatistics Unit, Division of Health Sciences, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Macaskill', 'Affiliation': 'Sydney School of Public Health, Faculty of Medicine and Health, The University of Sydney, Sydney, Australia.'}]",Statistics in medicine,['10.1002/sim.8119'] 1174,30361759,Maintaining endotracheal tube cuff pressure at 20 mmHg during anterior cervical spine surgery to prevent dysphagia: a double-blind randomized controlled trial.,"PURPOSE Anterior cervical spine surgery is associated with postoperative dysphagia, sore throat and dysphonia. It is unclear, whether this is caused by increased endotracheal tube (ETT) cuff pressure after retractor placement. This study aims to assess the effect of ETT cuff pressure adjustment on postoperative dysphagia, sore throat and dysphonia. METHODS In this, single-centre, observer and patient-blinded randomized controlled trial patients treated with anterior cervical spine surgery were randomized to adjustment of the ETT cuff pressure to 20 mmHg after placement of the retractor versus no adjustment. Primary outcome was the incidence and severity of postoperative dysphagia. Secondary outcomes were sore throat and dysphonia. Outcomes were evaluated on day one and 2 months after the operation. RESULTS Of 177 enrolled patients, 162 patients (92.5%) could be evaluated. The incidence of dysphagia was 75.9% on day one and 34.6% 2 months after surgery. Dysphagia in the intervention and control group was present in 77.8% versus 74.1% of patients on day one (odds ratio (OR) 1.2, 95% confidence interval (CI) (0.6-2.5)) and 28.4% versus 40.7% of patients after 2 months (OR 0.6, 95% CI 0.3-1.1), respectively. Severity of dysphagia, sore throat and dysphonia was similar in both groups. CONCLUSIONS Anterior cervical spine surgery is accompanied by a high incidence of postoperative dysphagia, lasting until at least 2 months after surgery in over a third of our patients. Adjusting ETT cuff pressure to 20 mmHg after retractor placement, as compared to controls, did not lower the risk for both short- and long-term dysphagia. Netherlands National Trial Registry Number: NTR 3542. These slides can be retrieved under electronic supplementary material.",2019,Dysphagia in the intervention and control group was present in 77.8% versus 74.1% of patients on day one (odds ratio (,"['177 enrolled patients, 162 patients (92.5%) could be evaluated', 'patients treated with anterior cervical spine surgery', 'anterior cervical spine surgery to prevent dysphagia']",['ETT cuff pressure adjustment'],"['endotracheal tube (ETT) cuff pressure', 'sore throat and dysphonia', 'incidence and severity of postoperative dysphagia', 'Dysphagia', 'incidence of dysphagia', 'Severity of dysphagia, sore throat and dysphonia', 'postoperative dysphagia, sore throat and dysphonia']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0442011', 'cui_str': 'Anterior cervical spine approach (qualifier value)'}, {'cui': 'C0037949', 'cui_str': 'Spinal Column'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0011168', 'cui_str': 'Dysphagia'}]","[{'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0456081', 'cui_str': 'Adjustment (procedure)'}]","[{'cui': 'C0180212', 'cui_str': 'Endotracheal tube cuff, device (physical object)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0242429', 'cui_str': 'Sore Throat'}, {'cui': 'C1527344', 'cui_str': 'Phonation Disorders'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0011168', 'cui_str': 'Dysphagia'}]",177.0,0.269911,Dysphagia in the intervention and control group was present in 77.8% versus 74.1% of patients on day one (odds ratio (,"[{'ForeName': 'Bastiaan A', 'Initials': 'BA', 'LastName': ""In 't Veld"", 'Affiliation': 'Department of Anaesthesiology, Haaglanden Medical Center, Lijnbaan 32, 2512 VA, The Hague, The Netherlands. b.in.t.veld@haaglandenmc.nl.'}, {'ForeName': 'Thijs C D', 'Initials': 'TCD', 'LastName': 'Rettig', 'Affiliation': 'Department of Anaesthesiology, Haaglanden Medical Center, Lijnbaan 32, 2512 VA, The Hague, The Netherlands.'}, {'ForeName': 'Naomi', 'Initials': 'N', 'LastName': 'de Heij', 'Affiliation': 'Department of Anaesthesiology, Haaglanden Medical Center, Lijnbaan 32, 2512 VA, The Hague, The Netherlands.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'de Vries', 'Affiliation': 'Department of Anaesthesiology, Haaglanden Medical Center, Lijnbaan 32, 2512 VA, The Hague, The Netherlands.'}, {'ForeName': 'Jasper F C', 'Initials': 'JFC', 'LastName': 'Wolfs', 'Affiliation': 'Department of Neurosurgery, Haaglanden Medical Center, The Hague, The Netherlands.'}, {'ForeName': 'Mark P', 'Initials': 'MP', 'LastName': 'Arts', 'Affiliation': 'Department of Neurosurgery, Haaglanden Medical Center, The Hague, The Netherlands.'}]","European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society",['10.1007/s00586-018-5798-3'] 1175,30789059,Can acceptance and commitment therapy facilitate psychological adjustment after a severe traumatic brain injury? A pilot randomized controlled trial.,"This study i⁠nvestigated if an Acceptance and Commitment Therapy (ACT) intervention (ACT-Adjust) can facilitate psychological adjustment and reduce psychological distress following severe traumatic brain injury (TBI). The study design comprised a single centre, two-armed, Phase II pilot randomized controlled trial. Nineteen individuals with severe TBI (PTA ≥7 days) who met a clinical threshold for psychological distress (Depression Anxiety Stress Scales-21; DASS > 9) were randomly allocated to either ACT-Adjust ( n  = 10) or an active control, Befriending Therapy ( n  = 9), in conjunction with a holistic rehabilitation programme. Primary (psychological flexibility, rehabilitation participation) and secondary (depression, anxiety & stress) outcomes were measured at three-time points (pre, post and follow up). Significant decreases were found for DASS-depression (group by time interaction, F 1,17  = 5.35, p  = .03) and DASS-stress (group by time interaction, F 1,17  = 5.69, p  = .03) in comparison to the Befriending group, but not for the primary outcome measures. The reduction in stress post-treatment was classed as clinically significant, however interaction differences for stress and depression were not maintained at one month follow up. Preliminary investigations indicate potential for ACT in decreasing psychological distress for individuals with a severe TBI with further sessions required to maintain treatment gains. The pilot results suggest further investigation is warranted in a larger scale clinical trial.",2020,"Significant decreases were found for DASS-depression (group by time interaction, F 1,17  = 5.35, p = .03) and DASS-stress (group by time interaction, F 1,17  = 5.69, p = .03) in comparison to the Befriending group, but not for the primary outcome measures.","['severe traumatic brain injury (TBI', 'Nineteen individuals with severe TBI (PTA ≥7 days) who met a clinical threshold for psychological distress (Depression Anxiety Stress Scales-21; DASS\u2009>\u20099', 'individuals with a severe TBI']","['ACT-Adjust (n\u2009=\u200910) or an active control, Befriending Therapy (n\u2009=\u20099), in conjunction with a holistic rehabilitation programme', 'Acceptance and Commitment Therapy (ACT) intervention (ACT-Adjust', 'ACT']","['DASS-stress', 'psychological distress', 'DASS-depression', 'Primary (psychological flexibility, rehabilitation participation) and secondary (depression, anxiety & stress) outcomes']","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0876926', 'cui_str': 'TBI (Traumatic Brain Injury)'}, {'cui': 'C0450337', 'cui_str': '19 (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0015522', 'cui_str': 'Factor Eleven'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0449864', 'cui_str': 'Threshold (property) (qualifier value)'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0222045'}]","[{'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C3658321', 'cui_str': 'Acceptance and Commitment Therapy'}]","[{'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",19.0,0.0980493,"Significant decreases were found for DASS-depression (group by time interaction, F 1,17  = 5.35, p = .03) and DASS-stress (group by time interaction, F 1,17  = 5.69, p = .03) in comparison to the Befriending group, but not for the primary outcome measures.","[{'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Whiting', 'Affiliation': 'Brain Injury Rehabilitation Research Group, Ingham Institute of Applied Medical Research, Sydney, Australia.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Deane', 'Affiliation': 'School of Psychology, University of Wollongong, Wollongong, Australia.'}, {'ForeName': 'Hamish', 'Initials': 'H', 'LastName': 'McLeod', 'Affiliation': 'Institute of Health and Wellbeing, University of Glasgow, Glasgow, Scotland.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Ciarrochi', 'Affiliation': 'Institute of Positive Psychology & Education, Australian Catholic University, Strathfield, Australia.'}, {'ForeName': 'Grahame', 'Initials': 'G', 'LastName': 'Simpson', 'Affiliation': 'Brain Injury Rehabilitation Research Group, Ingham Institute of Applied Medical Research, Sydney, Australia.'}]",Neuropsychological rehabilitation,['10.1080/09602011.2019.1583582'] 1176,30664267,Efficacy of Granulocyte Colony-stimulating Factor in the Management of Steroid-Nonresponsive Severe Alcoholic Hepatitis: A Double-Blind Randomized Controlled Trial.,"Severe alcoholic hepatitis (SAH) is often a progressive disease with high mortality and limited steroid responsiveness. Management options of steroid nonresponsive SAH (day 7 Lille score > 0.45) are limited. We assessed the efficacy and safety of granulocyte colony-stimulating factor (G-CSF) in steroid nonresponders. A randomized, double-blind, single-center trial (NCT01820208) was conducted between March 2013 and June 2016 in patients with histologically proven SAH, nonresponsive to 40 mg/day of prednisolone were randomized to G-CSF (12 doses, 300 μg each in 28 days) or placebo. Responders were continued with prednisolone. Of the 430 patients with SAH, 132 received steroid therapy. Of these, 33 (25%) were nonresponders and were randomized to G-CSF or placebo (14 in each group after exclusions). The baseline characteristics of both groups were comparable. The 28-day mortality was comparable between the groups (21.4%, G-CSF; 28.6%, placebo; P = 0.69). At 90 days, in the G-CSF but not in the placebo group, the Model for End-Stage Liver Disease reduced from 24.6 ± 3.9 to 19.4 ± 3.7 (P = 0.002) and Maddrey's discriminant function from 74.8 ± 22.8 to 57.4 ± 31 (P = 0.26). Infections were less common (28% versus 71%; P < 0.001) with lower 90-day mortality (35.7% versus 71.4%; P = 0.04) in the G-CSF than in the placebo group. On Cox regression analysis, receiving G-CSF (hazard ratio, 0.37; SD, 0.14-0.98; P = 0.04), and high baseline serum creatinine (hazard ratio, 4.12; SD, 1.7-10.3; P = 0.002) predicted day-90 outcomes in steroid nonresponsive SAH. Patients tolerated G-CSF without any major adverse events. Conclusion: Approximately one-quarter of patients with SAH do not respond to corticosteroid therapy. Administration of G-CSF is safe and helps to reduce the disease severity and 90-day mortality in these patients.",2019,Infections were less common (28% versus 71%; P < 0.001) with lower 90-day mortality (35.7% versus 71.4%; P = 0.04) in the G-CSF than in the placebo group.,"['Severe alcoholic hepatitis (SAH', 'March 2013 and June 2016 in patients with histologically proven SAH, nonresponsive to 40 mg/day of', 'Steroid-Nonresponsive Severe Alcoholic Hepatitis', '430 patients with SAH, 132 received', 'steroid nonresponders']","['G-CSF', 'placebo', 'granulocyte colony-stimulating factor (G-CSF', 'G-CSF or placebo', 'steroid therapy', 'Granulocyte Colony-stimulating Factor', 'prednisolone']","['90-day mortality', 'disease severity and 90-day mortality', '28-day mortality', 'efficacy and safety', 'high baseline serum creatinine']","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0019187', 'cui_str': 'Hepatitis, Alcoholic'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0456369', 'cui_str': 'Proven (qualifier value)'}, {'cui': 'C0439422', 'cui_str': 'mg/day'}, {'cui': 'C0038317', 'cui_str': 'Steroids'}]","[{'cui': 'C0079459', 'cui_str': 'G-CSF'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0018183', 'cui_str': 'Granulocytic cell'}, {'cui': 'C0439158', 'cui_str': 'colonies (qualifier value)'}, {'cui': 'C0149783', 'cui_str': 'Steroid therapy (procedure)'}, {'cui': 'C0032950', 'cui_str': 'prednisolone'}]","[{'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum (procedure)'}]",430.0,0.465369,Infections were less common (28% versus 71%; P < 0.001) with lower 90-day mortality (35.7% versus 71.4%; P = 0.04) in the G-CSF than in the placebo group.,"[{'ForeName': 'Saggere Muralikrishna', 'Initials': 'SM', 'LastName': 'Shasthry', 'Affiliation': 'Department of Hepatology, Institute of Liver & Biliary Sciences, New Delhi, India.'}, {'ForeName': 'Manoj Kumar', 'Initials': 'MK', 'LastName': 'Sharma', 'Affiliation': 'Department of Hepatology, Institute of Liver & Biliary Sciences, New Delhi, India.'}, {'ForeName': 'Varsha', 'Initials': 'V', 'LastName': 'Shasthry', 'Affiliation': 'Department of Hepatology, Institute of Liver & Biliary Sciences, New Delhi, India.'}, {'ForeName': 'Apurva', 'Initials': 'A', 'LastName': 'Pande', 'Affiliation': 'Department of Hepatology, Institute of Liver & Biliary Sciences, New Delhi, India.'}, {'ForeName': 'Shiv Kumar', 'Initials': 'SK', 'LastName': 'Sarin', 'Affiliation': 'Department of Hepatology, Institute of Liver & Biliary Sciences, New Delhi, India.'}]","Hepatology (Baltimore, Md.)",['10.1002/hep.30516'] 1177,30738783,Variation on Vocal Economy After Different Semioccluded Vocal Tract Exercises in Subjects With Normal Voice and Dysphonia.,"PURPOSE The present study aimed at observing the possible differential effects of eight semioccluded vocal tract exercises (SOVTE) on vocal economy measured by the Quasi Output Cost Ratio (QOCR). METHODS Thirty-six participants were included in this study. They were divided into two groups: an experimental group of subjects diagnosed with mild hyperfunctional dysphonia (n = 17) and a control group of vocally healthy subjects (n = 19). Participants were required to randomly select and produce a series of three SOVTE from a list of eight exercises. The electroglottographic based measure QOCR was used to calculate the vocal economy before and after each voice exercise. RESULTS Significant differences were found when comparing pre and poststages regardless of the vocal condition (normal voice or dysphonia) or the specific SOVTE used. Moreover, when individually comparing the effect of each SOVTE, only tube in water (10 cm) showed significant differences between pre and postconditions (QOCR values were higher after exercises). CONCLUSION In general, semioccluded vocal tract exercises tend to increase vocal economy regardless the vocal condition (normal voice or dysphonia) or the specific SOVTE used. Phonation into a tube submerged deep into water promoted the highest increase in vocal economy. An increased acoustic output, nonproportional increase in vocal folds adduction and an effortless voice production would cause this increase in vocal economy after water resistance therapy.",2020,"RESULTS Significant differences were found when comparing pre and poststages regardless of the vocal condition (normal voice or dysphonia) or the specific SOVTE used.","['Thirty-six participants were included in this study', 'Subjects With Normal Voice and Dysphonia', 'subjects diagnosed with mild hyperfunctional dysphonia (n\u202f=\u202f17) and a control group of vocally healthy subjects (n\u202f=\u202f19']","['Vocal Tract Exercises', 'eight semioccluded vocal tract exercises (SOVTE']","['vocal economy', 'vocal condition (normal voice or dysphonia', 'Vocal Economy', 'pre and postconditions (QOCR values', 'acoustic output, nonproportional increase in vocal folds adduction', 'Quasi Output Cost Ratio (QOCR', 'vocal economy regardless the vocal condition (normal voice or dysphonia']","[{'cui': 'C4319606', 'cui_str': 'Thirty-six'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0234759', 'cui_str': 'Normal voice (finding)'}, {'cui': 'C1527344', 'cui_str': 'Phonation Disorders'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0454547', 'cui_str': 'Hyperfunctional dysphonia (disorder)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0234759', 'cui_str': 'Normal voice (finding)'}, {'cui': 'C1527344', 'cui_str': 'Phonation Disorders'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0001166', 'cui_str': 'Acoustics'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0234772', 'cui_str': 'Vocal fold adduction, function (observable entity)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",36.0,0.0140977,"RESULTS Significant differences were found when comparing pre and poststages regardless of the vocal condition (normal voice or dysphonia) or the specific SOVTE used.","[{'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Calvache', 'Affiliation': 'Corporación Universitaria Iberoamericana, Department Communication Sciences and Disorders, Vocology Center, Bogotá, Colombia. Electronic address: carlos.calvache@ibero.edu.co.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Guzman', 'Affiliation': 'Universidad de los Andes, Chile, Department of Communication Sciences and Disorders, Las Condes Clinic, Department of Otolaryngology, Santiago, Chile.'}, {'ForeName': 'Marcelo', 'Initials': 'M', 'LastName': 'Bobadilla', 'Affiliation': 'Universidad de los Andes, Department of Communication Sciences and Disorders, Santiago, Chile.'}, {'ForeName': 'Cori', 'Initials': 'C', 'LastName': 'Bortnem', 'Affiliation': 'Corporación Universitaria Iberoamericana, Department Communication Sciences and Disorders, Vocology Center, Bogotá, Colombia.'}]",Journal of voice : official journal of the Voice Foundation,['10.1016/j.jvoice.2019.01.007'] 1178,31550051,Developing efficient and effective behavioral treatment for insomnia in cancer survivors: Results of a stepped care trial.,"BACKGROUND Insomnia is common among cancer survivors. Although behavioral treatments for insomnia are effective, access is limited. Stepped care delivery models may provide insomnia treatment that is more efficient and accessible to cancer survivors. METHODS Fifty-one survivors (mean age, 55 years) with elevated Insomnia Severity Index (ISI) scores (≥12) first participated in Sleep Training Education Program (STEP)-1: a single, sleep education session. Those reporting elevated ISI scores 1 month later were offered STEP-2: a 3-session, group cognitive behavioral treatment for insomnia that has been demonstrated to be efficacious. Participants were considered treatment responders if their ISI score improved by ≥6 points and were considered as having remitted if their posttreatment ISI score was <12. Mood was assessed with the Profile of Mood States-Short Form (POMS-SF). RESULTS Following STEP-1, ISI scores improved (17.1 to 11.2; P < .001), with 45% responding and 41% remitted. Insomnia remission after STEP-1 was associated with lower insomnia severity and shorter duration of sleep problems at baseline. Of the 30 (59%) survivors with unremitted insomnia after STEP-1, 14 (47%) participated in STEP-2. Following STEP-2, ISI scores improved (16.9 to 8.8; P < .001), with 79% responding and 71% remitted. STEP-2 participation was associated with interest in sleep treatment at baseline, but not demographic/health-related variables. Mood improved significantly following both STEP-1 and STEP-2 (P < .001). CONCLUSION A stepped care approach to treating insomnia among cancer survivors has the potential to improve treatment accessibility. A sizable proportion of survivors can benefit from 2 different low-intensity approaches that could be delivered by nonsleep specialists. For individuals who require more intensive care, assessing treatment interest can identify those who are likely to engage.",2020,Mood improved significantly following both STEP-1 and STEP-2,"['Fifty-one survivors (mean age, 55\xa0years) with elevated Insomnia Severity Index (ISI) scores (≥12) first participated in', 'cancer survivors']","['STEP-1 and STEP-2', 'Sleep Training Education Program (STEP)-1: a single, sleep education session']","['ISI score', 'Insomnia remission', 'insomnia severity and shorter duration of sleep problems', 'ISI scores']","[{'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4706228', 'cui_str': 'Insomnia Severity Index score (observable entity)'}, {'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}]","[{'cui': 'C1301776', 'cui_str': 'Step 1'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0729314', 'cui_str': 'Education provision (procedure)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0439593', 'cui_str': 'Short duration (qualifier value)'}, {'cui': 'C0700201', 'cui_str': 'Dyssomnias'}]",51.0,0.0672453,Mood improved significantly following both STEP-1 and STEP-2,"[{'ForeName': 'Eric S', 'Initials': 'ES', 'LastName': 'Zhou', 'Affiliation': ""Perini Family Survivors' Center, Dana-Farber Cancer Institute, Boston, Massachusetts.""}, {'ForeName': 'Alexis L', 'Initials': 'AL', 'LastName': 'Michaud', 'Affiliation': ""Perini Family Survivors' Center, Dana-Farber Cancer Institute, Boston, Massachusetts.""}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Recklitis', 'Affiliation': ""Perini Family Survivors' Center, Dana-Farber Cancer Institute, Boston, Massachusetts.""}]",Cancer,['10.1002/cncr.32509'] 1179,30734583,Effect of combined neurofeedback and game-based cognitive training on the treatment of ADHD: A randomized controlled study.,"Neurofeedback (NF) is referred to as a ""possibly efficacious"" treatment in the current evidence-based reviews; therefore, more research is needed to determine its effects especially in combination with other treatments. The present study examines the effect of NF and game-based cognitive training on children with attention deficit hyperactivity disorder (ADHD). Thirty-two male students with ADHD were assigned to NF ( N  = 16; M age =10.20; SD  = 1.03) and waiting list control ( N  = 16; M age = 10.05; SD  = 0.83) in a randomized double-blind trial. The children in the NF group based on quantitative electroencephalography (QEEG) attended 30 three times-weekly sessions. The children were examined in pretest and post-test with EEG, Integrated Visual and Auditory Continuous Performance (IVA), and Conners Parent, and Teacher Rating Scales-Revised. The treatment was found significant all the symptom variables except for attention deficit (AD) and auditory response control (ARC). Normalization of the atypical EEG features with reduced [Formula: see text] wave and increased sensory motor (SMR) activity in central zero (Cz) was recorded in the NF condition participants. However, except for SMR activity there were no significant changes in the waves of frontocentral zero (FCz). It is concluded that technology developments provide an interesting vehicle for interposing interventions and that combined NF and game-based cognitive training can produce positive therapeutic effects on brainwaves and ADHD symptomatology.",2020,The treatment was found significant all the symptom variables except for attention deficit (AD) and auditory response control (ARC).,"['children with attention deficit hyperactivity disorder (ADHD', 'Thirty-two male students with ADHD were assigned to NF (N\u2009=\u200916; M age =10.20; SD\u2009=\u20091.03) and waiting list control (N\u2009=\u200916; M age = 10.05; SD\u2009=\u20090.83', 'ADHD']","['Neurofeedback (NF', 'combined neurofeedback and game-based cognitive training', 'NF and game-based cognitive training']","['EEG, Integrated Visual and Auditory Continuous Performance (IVA), and Conners Parent, and Teacher Rating Scales-Revised', 'symptom variables except for attention deficit (AD) and auditory response control (ARC', 'quantitative electroencephalography (QEEG', 'sensory motor (SMR) activity in central zero (Cz', 'waves of frontocentral zero (FCz', 'SMR activity']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C0450357', 'cui_str': '32 (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C2713543', 'cui_str': 'Neurofeedback'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}]","[{'cui': 'C0013819', 'cui_str': 'EEG'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0439825', 'cui_str': 'Auditory (qualifier value)'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0221457', 'cui_str': 'Teacher (occupation)'}, {'cui': 'C0222045'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0332300', 'cui_str': 'Except for (attribute)'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0001857', 'cui_str': 'Lymphadenopathy Syndrome'}, {'cui': 'C0392762', 'cui_str': 'Quantitative (qualifier value)'}, {'cui': 'C0445254', 'cui_str': 'Sensory (qualifier value)'}, {'cui': 'C0026606', 'cui_str': 'Motor Activity'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0919414', 'cui_str': '0 (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}]",32.0,0.0373183,The treatment was found significant all the symptom variables except for attention deficit (AD) and auditory response control (ARC).,"[{'ForeName': 'Soran', 'Initials': 'S', 'LastName': 'Rajabi', 'Affiliation': 'General Psychology, Persian Gulf University, Boushehr, Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Pakize', 'Affiliation': 'General Psychology, Persian Gulf University, Boushehr, Iran.'}, {'ForeName': 'NozhatAlzaman', 'Initials': 'N', 'LastName': 'Moradi', 'Affiliation': 'General Psychology, Persian Gulf University, Boushehr, Iran.'}]",Applied neuropsychology. Child,['10.1080/21622965.2018.1556101'] 1180,31845316,The effect of intrathecal bupivacaine/morphine on quality of recovery in robot-assisted radical prostatectomy: a randomised controlled trial.,"Robot-assisted radical prostatectomy causes discomfort in the immediate postoperative period. This randomised controlled trial investigated if intrathecal bupivacaine/morphine, in addition to general anaesthesia, could be beneficial for the postoperative quality of recovery. One hundred and fifty-five patients were randomly allocated to an intervention group that received intrathecal 12.5 mg bupivacaine/300 μg morphine (20% dose reduction in patients > 75 years) or a control group receiving a subcutaneous sham injection and an intravenous loading dose of 0.1 mg.kg -1 morphine. Both groups received standardised general anaesthesia and the same postoperative analgesic regimen. The primary outcome was a decrease in the Quality of Recovery-15 (QoR-15) questionnaire score on postoperative day 1. The intervention group (n = 76) had less reduction in QoR-15 on postoperative day 1; median (IQR [range]) 10% (1-8 [-60% to 50%]) vs. 13% (5-24 [-6% to 50%]), p = 0.019, and used less morphine during the admission; 2 mg (1-7 [0-41 mg]) vs. 15 mg (12-20 [8-61 mg]), p < 0.001. Furthermore, they perceived lower pain scores during exertion; numeric rating scale (NRS) 3 (1-6 [0-9]) vs. 5 (3-7 [0-9]), p = 0.001; less bladder spasms (NRS 1 (0-2 [0-10]) vs. 2 (0-5 [0-10]), p = 0.001 and less sedation; NRS 2 (0-3 [0-10]) vs. 3 (2-6 [0-10]), p = 0.005. Moreover, the intervention group used less rescue medication. Pruritus was more severe in the intervention group; NRS 4 (1-7 [0-10]) vs. 0 (0-1 [0-10]), p = 0.000. We conclude that despite a modest increase in the incidence of pruritus, multimodal pain management with intrathecal bupivacaine/morphine remains a viable option for robot-assisted radical prostatectomy.",2020,"Pruritus was more severe in the intervention group; NRS 4 (1-7 [0-10]) vs. 0 (0-1 [0-10]), p = 0.000.","['One hundred and fifty-five patients', 'robot-assisted radical prostatectomy']","['control group receiving a subcutaneous sham injection and an intravenous loading dose of 0.1\xa0mg.kg -1 morphine', 'morphine', 'Robot-assisted radical prostatectomy', 'bupivacaine/morphine', 'standardised general anaesthesia', 'intrathecal 12.5\xa0mg bupivacaine/300\xa0μg morphine', 'intrathecal bupivacaine/morphine']","['Pruritus', 'bladder spasms', 'pain scores during exertion; numeric rating scale (NRS', 'Quality of Recovery-15 (QoR-15) questionnaire score', 'rescue medication', 'quality of recovery']","[{'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0336537', 'cui_str': 'Robot, device (physical object)'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0194810', 'cui_str': 'Radical prostatectomy (procedure)'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1522438', 'cui_str': 'SC use'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C3714444', 'cui_str': 'Loading dose'}, {'cui': 'C4517420', 'cui_str': 'Zero point one'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0336537', 'cui_str': 'Robot, device (physical object)'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0194810', 'cui_str': 'Radical prostatectomy (procedure)'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0002915', 'cui_str': 'General Anesthesia'}, {'cui': 'C4517544', 'cui_str': '12.5 (qualifier value)'}]","[{'cui': 'C0033774', 'cui_str': 'Pruritis'}, {'cui': 'C0426390', 'cui_str': 'Spasm of bladder (finding)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0015264', 'cui_str': 'Exertion, function (observable entity)'}, {'cui': 'C0222045'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",155.0,0.246728,"Pruritus was more severe in the intervention group; NRS 4 (1-7 [0-10]) vs. 0 (0-1 [0-10]), p = 0.000.","[{'ForeName': 'M V', 'Initials': 'MV', 'LastName': 'Koning', 'Affiliation': 'Department of Anaesthesiology, Erasmus Medical Centre, University Medical Centre Rotterdam, the Netherlands.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'de Vlieger', 'Affiliation': 'Department of Anaesthesiology, Erasmus Medical Centre, University Medical Centre Rotterdam, the Netherlands.'}, {'ForeName': 'A J W', 'Initials': 'AJW', 'LastName': 'Teunissen', 'Affiliation': 'Department of Anaesthesiology, Maasstad Hospital, Rotterdam, the Netherlands.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Gan', 'Affiliation': 'Department of Urology, Maasstad Hospital, Rotterdam, the Netherlands.'}, {'ForeName': 'E J', 'Initials': 'EJ', 'LastName': 'Ruijgrok', 'Affiliation': 'Department of Hospital Pharmacy, Erasmus Medical Centre, University Medical Centre Rotterdam, the Netherlands.'}, {'ForeName': 'J C', 'Initials': 'JC', 'LastName': 'de Graaff', 'Affiliation': 'Department of Anaesthesiology, Erasmus Medical Centre, University Medical Centre Rotterdam, the Netherlands.'}, {'ForeName': 'J S H A', 'Initials': 'JSHA', 'LastName': 'Koopman', 'Affiliation': 'Department of Anaesthesiology, Maasstad Hospital, Rotterdam, the Netherlands.'}, {'ForeName': 'R J', 'Initials': 'RJ', 'LastName': 'Stolker', 'Affiliation': 'Department of Anaesthesiology, Erasmus Medical Centre, University Medical Centre Rotterdam, the Netherlands.'}]",Anaesthesia,['10.1111/anae.14922'] 1181,30467071,Role of rs670 variant of APOA1 gene on metabolic response after a high fat vs. a low fat hypocaloric diets in obese human subjects.,"BACKGROUND & AIMS A common G-to-A transition located 75 base pairs upstream (rs670) from transcription start site of the APOA1 gene has been related with some metabolic parameters. Our aim was to analyze the effects of rs670 APOA1 gene polymorphism on lipid profile and metabolic changes after two different hypocaloric diets. METHODS 282 obese subjects were randomly allocated during 12 weeks (Diet HF - high fat diet vs. Diet LF - low fat diet). Anthropometric and biochemical status were evaluated. RESULTS Body mass index, weight, fat mass, waist circumference, systolic blood pressure, leptin levels and waist circumference decreased in all patients in average after both diets. In A allele carriers after 12 weeks with both diets, insulin levels (Delta diet HF: -5.3 + 1.2 UI/L; P = 0.02 and Delta diet LF: -5.8 + 1.3 UI/L; P = 0.02) and HOMA-IR (Delta diet HF: -2.9 + 0.8 units; P = 0.01 and Delta diet LF: -2.2 + 0.9 units; P = 0.03) improved in a significant way. With the low fat diet, A allele carriers showed a statistical improvement in HDL-cholesterol levels (Delta: 4 + 1 mg/dl; P = 0.03). CONCLUSIONS Our study showed the association of rs670 ApoA1 polymorphism with a decrease of insulin resistance induced by both diets and provided additional evidence on HDL-cholesterol increase after a LF hypocaloric diet in A allele carriers.",2019,"RESULTS Body mass index, weight, fat mass, waist circumference, systolic blood pressure, leptin levels and waist circumference decreased in all patients in average after both diets.","['282 obese subjects', 'obese human subjects']",['Diet HF - high fat diet vs. Diet LF - low fat diet'],"['insulin resistance', 'HDL-cholesterol increase', 'lipid profile and metabolic changes', 'metabolic response', 'HDL-cholesterol levels', 'Body mass index, weight, fat mass, waist circumference, systolic blood pressure, leptin levels and waist circumference', 'HOMA-IR']","[{'cui': 'C4517681', 'cui_str': '282'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0080105', 'cui_str': 'Human Subjects'}]","[{'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0521974', 'cui_str': 'Diet, High-Fat'}, {'cui': 'C0242970', 'cui_str': 'Fat-Restricted Diet'}]","[{'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C2938903', 'cui_str': 'HDL cholesterol increased'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0018667', 'cui_str': 'Cholesterol, HDL2'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0299583', 'cui_str': 'leptin'}]",282.0,0.0286492,"RESULTS Body mass index, weight, fat mass, waist circumference, systolic blood pressure, leptin levels and waist circumference decreased in all patients in average after both diets.","[{'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'de Luis', 'Affiliation': 'Endocrinology and Nutrition Research Center, School of Medicine, Department of Endocrinology and Nutrition, Hospital Clinico Universitario, University of Valladolid, Valladolid, Spain. Electronic address: dadluis@yahoo.es.'}, {'ForeName': 'Olatz', 'Initials': 'O', 'LastName': 'Izaola', 'Affiliation': 'Endocrinology and Nutrition Research Center, School of Medicine, Department of Endocrinology and Nutrition, Hospital Clinico Universitario, University of Valladolid, Valladolid, Spain.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Primo', 'Affiliation': 'Endocrinology and Nutrition Research Center, School of Medicine, Department of Endocrinology and Nutrition, Hospital Clinico Universitario, University of Valladolid, Valladolid, Spain.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Aller', 'Affiliation': 'Endocrinology and Nutrition Research Center, School of Medicine, Department of Endocrinology and Nutrition, Hospital Clinico Universitario, University of Valladolid, Valladolid, Spain.'}]",Journal of diabetes and its complications,['10.1016/j.jdiacomp.2018.10.015'] 1182,32407786,Study To Reduce Infection Prior to Elective Cesarean Deliveries (STRIPES): a randomized clinical trial of chlorhexidine.,"BACKGROUND Surgical site infections after cesarean delivery are a cause of maternal morbidity and are typically caused by skin microbial flora. Preadmission application of chlorhexidine gluconate using impregnated cloths may decrease surgical site infections by decreasing the abundance of microbial flora. OBJECTIVE To determine whether the application of chlorhexidine gluconate cloths the night before and the morning of scheduled cesarean delivery decreases the risk of surgical site infections by 6 weeks postoperatively compared with placebo. STUDY DESIGN In this single-center, double-blind, placebo-controlled trial, patients were randomized (1:1) to receive either Sage 2% chlorhexidine cloths or Sage Comfort Bath fragrance-free cloths (placebo) to apply to 6 skin sites on the body (neck, shoulders and chest, armpits, arm and hands, abdomen and groin, left leg and foot, right leg and foot, back and buttocks) the night before and after a shower the morning of scheduled cesarean delivery. Routine clinical and operative procedures were followed. The primary outcome was surgical site infections (superficial or deep incisional with or without organ space endometritis) by 6 weeks after cesarean delivery. The secondary outcomes were surgical site infections by 2 weeks and other wound-related complications by 2 and 6 weeks after cesarean delivery. RESULTS From April 2015 to August 2019, 1356 patients were enrolled: 682 were assigned to the chlorhexidine group and 674 to the placebo group. The groups were similar in demographic and medical characteristics. A total of 14 patients were lost to follow-up before cesarean delivery (10 in chlorhexidine and 4 in placebo) and 33 were lost to follow-up after cesarean delivery (10 in chlorhexidine and 23 in placebo). Among the remaining 1309 (97%), no difference was found in surgical site infections by 6 weeks between the 2 groups (2.6% in chlorhexidine vs 3.7% in placebo; P=.24). There were no differences in secondary outcomes at 2 or 6 weeks and no differences in primary outcome in a per-protocol analysis. CONCLUSION Preadmission use of chlorhexidine gluconate cloths compared with placebo does not reduce the risk of surgical site infection after scheduled cesarean deliveries. Following the standard of care guidelines results in a low risk of surgical site infections in this group of patients.",2020,Patients and physicians who follow the standard of care guidelines have a low risk of surgical site infections in this group of patients.,"['1,356 patients were enrolled: 682', 'From April 2015 through August 2019', 'Prior to Elective Cesarean Deliveries (STRIPES', 'Fourteen patients were lost to follow-up prior to cesarean delivery (10 in']","['chlorhexidine gluconate-impregnated cloths', 'chlorhexidine and 23 in placebo', 'chlorhexidine', 'Sage 2% chlorhexidine cloths or Sage Comfort Bath fragrance-free cloths (placebo', 'chlorhexidine gluconate', 'chlorhexidine and 4 in placebo', 'placebo']","['risk of surgical site infections', 'surgical site infection', 'surgical site infections (superficial or deep -incisional and/or organ space-endometritis', 'surgical site infections by 2 weeks and other wound-related complications', 'Infection', 'surgical site infections']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0473296', 'cui_str': 'Elective cesarean section'}, {'cui': 'C1532935', 'cui_str': 'Striped'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C1302313', 'cui_str': 'Lost to follow-up'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}]","[{'cui': 'C0055361', 'cui_str': 'Chlorhexidine gluconate'}, {'cui': 'C0039717', 'cui_str': 'Textiles'}, {'cui': 'C0008196', 'cui_str': 'Chlorhexidine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1122976', 'cui_str': 'Sage'}, {'cui': 'C0031000', 'cui_str': 'Perfume'}, {'cui': 'C0332296', 'cui_str': 'Free of'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0038941', 'cui_str': 'Postoperative wound infection'}, {'cui': 'C0205124', 'cui_str': 'Superficial'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}, {'cui': 'C0014179', 'cui_str': 'Endometritis'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}]",1356.0,0.327365,Patients and physicians who follow the standard of care guidelines have a low risk of surgical site infections in this group of patients.,"[{'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Stone', 'Affiliation': 'Department of Obstetrics, Gynecology and Reproductive Sciences, Icahn School of Medicine at Mount Sinai, New York, NY. Electronic address: joanne.stone@mssm.edu.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Bianco', 'Affiliation': 'Department of Obstetrics, Gynecology and Reproductive Sciences, Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Monro', 'Affiliation': 'Department of Obstetrics, Gynecology and Reproductive Sciences, Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'Jessica R', 'Initials': 'JR', 'LastName': 'Overybey', 'Affiliation': 'Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Cadet', 'Affiliation': 'Department of Obstetrics, Gynecology and Reproductive Sciences, Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'Katie Hyewon', 'Initials': 'KH', 'LastName': 'Choi', 'Affiliation': 'Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Pena', 'Affiliation': 'Department of Obstetrics, Gynecology and Reproductive Sciences, Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'Brittany N', 'Initials': 'BN', 'LastName': 'Robles', 'Affiliation': 'Department of Obstetrics, Gynecology and Reproductive Sciences, Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'Maria T', 'Initials': 'MT', 'LastName': 'Mella', 'Affiliation': 'Department of Obstetrics, Gynecology and Reproductive Sciences, Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'Kathy C', 'Initials': 'KC', 'LastName': 'Matthews', 'Affiliation': 'Department of Obstetrics, Gynecology and Reproductive Sciences, Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'Stephanie H', 'Initials': 'SH', 'LastName': 'Factor', 'Affiliation': 'Department of Obstetrics, Gynecology and Reproductive Sciences, Icahn School of Medicine at Mount Sinai, New York, NY.'}]",American journal of obstetrics and gynecology,['10.1016/j.ajog.2020.05.021'] 1183,30709694,Randomized controlled clinical effectiveness of adjunct 660-nm light-emitting diode irradiation during non-surgical periodontal therapy.,"BACKGROUND/PURPOSE The irradiation of 660-nm light-emitting diodes (LEDs) has exhibited potential to accelerate oral wound healing and prevent periodontal breakdown in rodents. This study was to evaluate the clinical effectiveness of 660-nm LEDs during non-surgical periodontal therapy (NSPT). METHODS Nineteen patients with at least one periodontitis-involved tooth in three quadrants received NSPT, and three protocols of LED light irradiation, including LED light irradiation from initial clinical assessment (T0) until the completion of scaling and root planning (T1) (LED01), LED light irradiation from T1 until re-evaluation (T2) (LED02), and no LED light irradiation (control treatment), were randomly assigned to respective quadrant. Clinical parameters were assessed at T0 and T2, and such biomarkers as IL-1β and MMP-8 from gingival crevicular fluid were assessed at T0, T1, and T2. RESULTS At T2, all examined sites exhibited significantly reduced probing pocket depth (PD), clinical attachment level (CAL), gingival bleeding index, plaque score, and visual analog scale. In the sites with greatest initial PD and CAL, LED01 and LED02 significantly reduced PD and CAL compared with the control treatment. IL-1β and MMP-8 were reduced in all groups at T1 and T2, and the reduction of MMP-8 was the most notable in LED01. CONCLUSION LED light irradiation during or after scaling and root planing assisted in the recovery of periodontium and can be used as an adjunct treatment during NSPT, specifically for sites with severe periodontal breakdown.",2020,The irradiation of 660-nm light-emitting diodes (LEDs) has exhibited potential to accelerate oral wound healing and prevent periodontal breakdown in rodents.,['Nineteen patients with at least one periodontitis-involved tooth in three quadrants received'],"['NSPT, and three protocols of LED light irradiation, including LED light irradiation from initial clinical assessment (T0) until the completion of scaling and root planning (T1) (LED01), LED light irradiation from T1 until re-evaluation (T2) (LED02), and no LED light irradiation (control treatment', '660-nm light-emitting diodes (LEDs', '660-nm LEDs during non-surgical periodontal therapy (NSPT', 'adjunct 660-nm light-emitting diode irradiation', 'IL-1β', 'LED light irradiation']","['and MMP-8', 'IL-1β and MMP-8 from gingival crevicular fluid', 'probing pocket depth (PD), clinical attachment level (CAL), gingival bleeding index, plaque score, and visual analog scale', 'reduction of MMP-8', 'PD and CAL']","[{'cui': 'C0450337', 'cui_str': '19 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0031099', 'cui_str': 'Periodontitis'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C0040426', 'cui_str': 'Tooth'}]","[{'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0332264', 'cui_str': 'Light (weight) (qualifier value)'}, {'cui': 'C1282930', 'cui_str': 'Irradiation (physical force)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0563017', 'cui_str': 'Anal penetration using finger (finding)'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning (observable entity)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4517845', 'cui_str': '660'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}]","[{'cui': 'C0623362', 'cui_str': 'MMPs'}, {'cui': 'C0017564', 'cui_str': 'Gingival Exudate'}, {'cui': 'C3179165', 'cui_str': 'Probe (methazole)'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0580084', 'cui_str': 'Gingival bleeding index (observable entity)'}, {'cui': 'C0332461', 'cui_str': 'Plaque (morphologic abnormality)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C1879985', 'cui_str': 'calorie'}]",19.0,0.0520632,The irradiation of 660-nm light-emitting diodes (LEDs) has exhibited potential to accelerate oral wound healing and prevent periodontal breakdown in rodents.,"[{'ForeName': 'Yi-Wen', 'Initials': 'YW', 'LastName': 'Chen', 'Affiliation': 'Graduate Institute of Clinical Dentistry, School of Dentistry, National Taiwan University, Taipei, Taiwan; Department of Dentistry, National Taiwan University Hospital, Taipei, Taiwan.'}, {'ForeName': 'Olivia', 'Initials': 'O', 'LastName': 'Hsieh', 'Affiliation': 'Graduate Institute of Clinical Dentistry, School of Dentistry, National Taiwan University, Taipei, Taiwan.'}, {'ForeName': 'Yueh-An', 'Initials': 'YA', 'LastName': 'Chen', 'Affiliation': 'Graduate Institute of Clinical Dentistry, School of Dentistry, National Taiwan University, Taipei, Taiwan; Department of Dentistry, National Taiwan University Hospital, Taipei, Taiwan.'}, {'ForeName': 'Lan-Lin', 'Initials': 'LL', 'LastName': 'Chiou', 'Affiliation': 'Department of Dentistry, National Taiwan University Hospital, Taipei, Taiwan.'}, {'ForeName': 'Po-Chun', 'Initials': 'PC', 'LastName': 'Chang', 'Affiliation': 'Graduate Institute of Clinical Dentistry, School of Dentistry, National Taiwan University, Taipei, Taiwan; Department of Dentistry, National Taiwan University Hospital, Taipei, Taiwan. Electronic address: changpc@ntu.edu.tw.'}]",Journal of the Formosan Medical Association = Taiwan yi zhi,['10.1016/j.jfma.2019.01.010'] 1184,30763730,Osimertinib Plus Durvalumab versus Osimertinib Monotherapy in EGFR T790M-Positive NSCLC following Previous EGFR TKI Therapy: CAURAL Brief Report.,"INTRODUCTION Osimertinib is a third-generation EGFR-tyrosine kinase inhibitor (TKI). Durvalumab is an anti-programmed death ligand 1 monoclonal antibody. The phase III open-label CAURAL trial (NCT02454933) investigated osimertinib plus durvalumab versus osimertinib monotherapy in patients with EGFR-TKI sensitizing and EGFR T790M mutation-positive advanced NSCLC and disease progression after EGFR-TKI therapy. METHODS Patients were randomly assigned 1:1 to receive orally administered osimertinib (80 mg once daily) with or without durvalumab (10 mg/kg administered intravenously every 2 weeks) until progression. Treatment could continue beyond progression, providing clinical benefit continued (judged by the investigator). The amended primary objective was to assess the safety and tolerability of osimertinib plus durvalumab; efficacy was an exploratory objective. RESULTS CAURAL recruitment was terminated early because of increased incidence of interstitial lung disease-like events in the osimertinib plus durvalumab arm from the separate phase Ib TATTON trial (NCT02143466). At termination of CAURAL recruitment, 15 patients had been randomly assigned to treatment with osimertinib and 14 to treatment with osimertinib plus durvalumab. The most common AEs were diarrhea (53% [grade ≥3 in 6% of patients]) in the osimertinib arm and rash (67% [grade ≥3 in 0 patients]) in the combination arm. One patient who had been randomized to the combination arm reported grade 2 interstitial lung disease while receiving osimertinib monotherapy (after discontinuing durvalumab therapy after one dose). The objective response rates were 80% in the osimertinib arm and 64% in the combination arm. CONCLUSION Limited patient numbers preclude formal safety and efficacy comparisons between the two treatment arms. The combination of programmed cell death 1/programmed death ligand 1 inhibitors and EGFR-TKIs as therapy for NSCLC is not well understood, but it requires a careful approach if considered in the future.",2019,The most common AEs were diarrhea (53% [grade ≥3 in 6% of patients]) in the osimertinib arm and rash (67% [grade ≥3 in 0 patients]) in the combination arm.,"['Patients', 'patients with EGFR-TKI sensitizing and EGFR T790M mutation-positive advanced NSCLC and disease progression after EGFR-TKI therapy']","['osimertinib monotherapy', 'osimertinib (80 mg once daily) with or\xa0without durvalumab', 'osimertinib plus durvalumab', 'osimertinib plus durvalumab versus osimertinib monotherapy', 'Osimertinib Plus Durvalumab versus Osimertinib Monotherapy']","['safety and tolerability', 'formal safety and efficacy comparisons', 'grade 2 interstitial lung disease', 'objective response rates', 'diarrhea', 'interstitial lung disease-like events', 'rash']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0026882', 'cui_str': 'Mutation'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0242656', 'cui_str': 'Disease Progression'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C4058811', 'cui_str': 'osimertinib'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}, {'cui': 'C4055109', 'cui_str': 'durvalumab'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C1869044', 'cui_str': 'Interstitial lung disease (SMQ)'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0015230', 'cui_str': 'Skin Rash'}]",,0.195003,The most common AEs were diarrhea (53% [grade ≥3 in 6% of patients]) in the osimertinib arm and rash (67% [grade ≥3 in 0 patients]) in the combination arm.,"[{'ForeName': 'James Chih-Hsin', 'Initials': 'JC', 'LastName': 'Yang', 'Affiliation': 'Department of Oncology, National Taiwan University Hospital, Taipei, Taiwan, Republic of China. Electronic address: chihyang@ntu.edu.tw.'}, {'ForeName': 'Frances A', 'Initials': 'FA', 'LastName': 'Shepherd', 'Affiliation': 'Department of Medical Oncology and Hematology, Princess Margaret Cancer Centre and the University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Dong-Wan', 'Initials': 'DW', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Seoul National University Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Gyeong-Won', 'Initials': 'GW', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, Gyeongsang National University Hospital, Gyeongsang National University College of Medicine, Jinju, Republic of Korea.'}, {'ForeName': 'Jong Seok', 'Initials': 'JS', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, Republic of Korea.'}, {'ForeName': 'Gee-Chen', 'Initials': 'GC', 'LastName': 'Chang', 'Affiliation': 'Division of Chest Medicine, Department of Internal Medicine, Taichung Veterans General Hospital, Taichung, Taiwan, Republic of China; Faculty of Medicine, School of Medicine, National Yang-Ming University, Taipei, Republic of China.'}, {'ForeName': 'Sung Sook', 'Initials': 'SS', 'LastName': 'Lee', 'Affiliation': 'Hematology-Oncology, Inje University College of Medicine, Busan, Republic of Korea.'}, {'ForeName': 'Yu-Feng', 'Initials': 'YF', 'LastName': 'Wei', 'Affiliation': 'Department of Internal Medicine, E-Da Hospital/I-Shou University, Kaohsiung, Taiwan, Republic of China.'}, {'ForeName': 'Yun Gyoo', 'Initials': 'YG', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Laus', 'Affiliation': 'AstraZeneca, Cambridge, United Kingdom.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Collins', 'Affiliation': 'AstraZeneca, Cambridge, United Kingdom.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Pisetzky', 'Affiliation': 'AstraZeneca, Den Haag, The Netherlands.'}, {'ForeName': 'Leora', 'Initials': 'L', 'LastName': 'Horn', 'Affiliation': 'Thoracic Oncology Program, Vanderbilt University Medical Center, Nashville, Tennessee.'}]",Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer,['10.1016/j.jtho.2019.02.001'] 1185,31675546,A randomized controlled trial evaluating integrated versus phased application of evidence-based psychotherapies for military veterans with comorbid PTSD and substance use disorders.,"OBJECTIVE Recent clinical practice guidelines recommend the delivery of evidence-based psychotherapies for both substance use disorder (SUD) and posttraumatic stress disorder (PTSD) within the same treatment episode for patients with SUD/PTSD comorbidity. This randomized clinical trial evaluated the comparative effectiveness of integrating versus phasing evidence-based psychotherapies for SUD and PTSD among veterans with co-occurring SUD/ PTSD. METHOD 183 veterans with DSM-IV PTSD and SUD at two VA Medical Centers were randomized to one of two psychotherapies during which Motivational Enhancement Therapy [MET] for SUD and Prolonged Exposure [PE] for PTSD were either phased or integrated throughout treatment. Primary outcomes as evaluated by blinded assessors were percent days with drug use or heavy drinking and PTSD symptomology. We hypothesized integrated MET/PE (n = 95) would yield better SUD and PTSD-related outcomes at posttreatment than phased MET/PE (n = 88). RESULTS In intent-to-treat analyses (n=183), both treatment groups achieved clinically (d=0.46 - 1.06) and statistically significant reductions in SUD (p < 0.01) and PTSD (p < 0.01) symptomology; the time by treatment interactions were not significant. Post-hoc analyses could not confirm statistical non-inferiority; between-group effect sizes suggest a lack of clinically-meaningful differences between the two treatment approaches (d=0.08 - 0.27). CONCLUSIONS Our hypothesis that integrated MET/PE would result in better outcomes than phased MET/PE across a range of PTSD and SUD measures was not supported; both strategies for combining two single-disorder treatments for co-occurring SUD/PTSD yielded significant symptom reduction.",2019,"Post-hoc analyses could not confirm statistical non-inferiority; between-group effect sizes suggest a lack of clinically-meaningful differences between the two treatment approaches (d=0.08 - 0.27). ","['military veterans with comorbid PTSD and substance use disorders', '183 veterans with DSM-IV PTSD and SUD at two VA Medical Centers', 'veterans with co-occurring SUD/ PTSD', 'patients with SUD/PTSD comorbidity']","['psychotherapies during which Motivational Enhancement Therapy [MET] for SUD and Prolonged Exposure [PE', 'evidence-based psychotherapies', 'integrating versus phasing evidence-based psychotherapies']","['drug use or heavy drinking and PTSD symptomology', 'PTSD', 'SUD']","[{'cui': 'C0026126', 'cui_str': 'Armed Forces Personnel'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0038586', 'cui_str': 'Substance Use Disorders'}, {'cui': 'C4517615', 'cui_str': 'One hundred and eighty-three'}, {'cui': 'C0220952', 'cui_str': 'DSM-IV'}, {'cui': 'C0565990', 'cui_str': 'Medical center (environment)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}]","[{'cui': 'C1273567', 'cui_str': 'Psychotherapy (specialty)'}, {'cui': 'C1627358', 'cui_str': 'Refractive surgery enhancement'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439590', 'cui_str': 'Prolonged (qualifier value)'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}]","[{'cui': 'C0449889', 'cui_str': 'Drug used (attribute)'}, {'cui': 'C0439539', 'cui_str': 'Heavy sensation quality'}, {'cui': 'C0684271', 'cui_str': 'Drinkings'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}]",183.0,0.0395958,"Post-hoc analyses could not confirm statistical non-inferiority; between-group effect sizes suggest a lack of clinically-meaningful differences between the two treatment approaches (d=0.08 - 0.27). ","[{'ForeName': 'Shannon M', 'Initials': 'SM', 'LastName': 'Kehle-Forbes', 'Affiliation': ""National Center for PTSD Women's Health Sciences Division at VA Boston Healthcare System, 150 S Huntington Ave, Boston, MA 02130, United States; Minneapolis VA Healthcare System, One Veterans Drive, Minneapolis, MN 55417, United States; University of Minnesota Medical School, 420 Delaware St SE, Minneapolis, MN 55455, United States. Electronic address: Shannon.Kehle-Forbes@va.gov.""}, {'ForeName': 'Shirley', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': 'Mental Illness Research, Education, and Clinical Center at the Corporal Michael J. Crescenz VA Medical Center, 3900 Woodland Ave, Philadelphia, PA 19104, United States.'}, {'ForeName': 'Melissa A', 'Initials': 'MA', 'LastName': 'Polusny', 'Affiliation': 'Minneapolis VA Healthcare System, One Veterans Drive, Minneapolis, MN 55417, United States; Department of Psychiatry, University of Minnesota, 2450 Riverside Ave S, Minneapolis MN 55454, United States.'}, {'ForeName': 'Kevin G', 'Initials': 'KG', 'LastName': 'Lynch', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, 3535 Market St, Philadelphia, PA 19104, United States.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Koffel', 'Affiliation': 'Minneapolis VA Healthcare System, One Veterans Drive, Minneapolis, MN 55417, United States; Department of Psychiatry, University of Minnesota, 2450 Riverside Ave S, Minneapolis MN 55454, United States.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Ingram', 'Affiliation': 'Mental Illness Research, Education, and Clinical Center at the Corporal Michael J. Crescenz VA Medical Center, 3900 Woodland Ave, Philadelphia, PA 19104, United States.'}, {'ForeName': 'Edna B', 'Initials': 'EB', 'LastName': 'Foa', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, 3535 Market St, Philadelphia, PA 19104, United States.'}, {'ForeName': 'Deborah H A', 'Initials': 'DHA', 'LastName': 'Van Horn', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, 3535 Market St, Philadelphia, PA 19104, United States.'}, {'ForeName': 'Michelle L', 'Initials': 'ML', 'LastName': 'Drapkin', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, 3535 Market St, Philadelphia, PA 19104, United States; Rutgers, The State University of New Jersey, 61 Nichol Ave, New Brunswick, NJ 08901, United States.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Yusko', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, 3535 Market St, Philadelphia, PA 19104, United States.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Oslin', 'Affiliation': 'Mental Illness Research, Education, and Clinical Center at the Corporal Michael J. Crescenz VA Medical Center, 3900 Woodland Ave, Philadelphia, PA 19104, United States; Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, 3535 Market St, Philadelphia, PA 19104, United States.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2019.107647'] 1186,30657230,A randomized pilot trial of a school-based psychoeducational intervention for children with asthma.,"BACKGROUND Asthma is a common childhood illness with high morbidity and mortality among minority and socio-economically disadvantaged children. Disparities are not fully accounted for by differences in asthma prevalence, highlighting a need for interventions targeting factors associated with poorer asthma control. One such factor is psychological stress. OBJECTIVE Here, we examine the feasibility and acceptability of ""I Can Cope (ICC),"" a school-based stress management and coping intervention for children with asthma. METHODS A parallel randomized pilot trial was conducted. One hundred and four low-income children (mean age 10 years; 54% male; 70% African American) with persistent asthma were recruited from 12 urban schools and randomized to the following: (a) ICC or one of two control conditions: (b) ""Open Airways for Schools (OAS)""-an asthma education intervention or (c) no treatment. RESULTS Seventy one percentage of eligible children participated in the study, with a dropout rate of 12%. ICC was rated as highly acceptable by participating children and parents. Preliminary efficacy data suggest that when compared with no treatment, ICC resulted in decreased symptoms of depression, perceived stress and child-reported symptoms of asthma, and improvements in sleep quality and child-reported asthma control. There were no intervention-related changes in objective measures of asthma morbidity. The magnitude of intervention effects on psychological function did not differ between the ICC and OAS groups. CONCLUSIONS Results support the feasibility and acceptability of utilizing school-based interventions to access hard to reach children with asthma. Preliminary findings offer support for future, large-scale efficacy studies of school-based interventions designed to target multiple factors that contribute to asthma disparities.",2019,"Preliminary efficacy data suggest that when compared with no treatment, ICC resulted in decreased symptoms of depression, perceived stress and child-reported symptoms of asthma, and improvements in sleep quality and child-reported asthma control.","['One hundred and four low-income children (mean age 10\xa0years; 54% male; 70% African American) with persistent asthma were recruited from 12 urban schools', 'minority and socio-economically disadvantaged children', 'Seventy one percentage of eligible children', 'children with asthma']","['ICC', 'school-based psychoeducational intervention', 'I Can Cope (ICC),"" a school-based stress management and coping intervention', 'ICC or one of two control conditions: (b) ""Open Airways for Schools (OAS)""-an asthma education intervention or (c) no treatment']","['sleep quality and child-reported asthma control', 'asthma morbidity', 'psychological function', 'symptoms of depression, perceived stress and child-reported symptoms of asthma']","[{'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0302604', 'cui_str': 'Low income'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C3266628', 'cui_str': 'Persistent asthma'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0450389', 'cui_str': '71 (qualifier value)'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}]","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0150788', 'cui_str': 'Manage stress control'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C1679754', 'cui_str': 'Asthma education (procedure)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0233398', 'cui_str': 'Psychological function'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",104.0,0.0268925,"Preliminary efficacy data suggest that when compared with no treatment, ICC resulted in decreased symptoms of depression, perceived stress and child-reported symptoms of asthma, and improvements in sleep quality and child-reported asthma control.","[{'ForeName': 'Anna L', 'Initials': 'AL', 'LastName': 'Marsland', 'Affiliation': 'University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Gentile', 'Affiliation': 'Duquesne University, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Hinze-Crout', 'Affiliation': 'University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Camilla', 'Initials': 'C', 'LastName': 'von Stauffenberg', 'Affiliation': 'University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Rhonda K', 'Initials': 'RK', 'LastName': 'Rosen', 'Affiliation': 'University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Tavares', 'Affiliation': 'University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Votruba-Drzal', 'Affiliation': 'University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Sheldon', 'Initials': 'S', 'LastName': 'Cohen', 'Affiliation': 'Carnegie Mellon University, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Elizabeth L', 'Initials': 'EL', 'LastName': 'McQuaid', 'Affiliation': 'Brown University, Providence, Rhode Island.'}, {'ForeName': 'Linda J', 'Initials': 'LJ', 'LastName': 'Ewing', 'Affiliation': 'University of Pittsburgh, Pittsburgh, Pennsylvania.'}]",Clinical and experimental allergy : journal of the British Society for Allergy and Clinical Immunology,['10.1111/cea.13337'] 1187,31646668,Influence of Ibuprofen on Bone Healing After Colles' Fracture: A Randomized Controlled Clinical Trial.,"Non-steroidal anti-inflammatory drugs (NSAIDs) may delay bone healing. [Therefore, it is important to establish whether NSAID preparations delay bone healing and what correlations, if any, exist between different bone studies-DEXA-scanning, bone markers, roentgenology controls, and histological examination of newly formed bone]. The purpose of this prospective controlled study was to investigate whether ibuprofen affects bone mineral density, turnover biomarkers, and histomorphometric characteristics of the callus after a Colles' fracture. This study was a single-center, triple-blinded, randomized clinical trial. Ninety-five patients (80 females) with displaced Colles' fracture, median age 65 (range 40-85) years were included in the study and operated on by external fixation from June 2012 through to June 2015. Eighty-nine patients received interventional medicine and 83 completed the 1-year follow-up. The 7-day ibuprofen group received 600 mg of ibuprofen three times a day (N = 29), the 3-day ibuprofen group received ibuprofen for 3 days (N = 30) and a placebo for the following 4 days, and finally, the placebo group received a placebo for 7 days (N = 30). The primary outcome was the difference in bone mineral density between the ultra-distal region of the injured and non-injured radius at 3 months after surgery. The histomorphometric outcomes included the assessment of callus tissue volume and surface fractions at 6 weeks postoperatively. The biomarkers Osteocalcin and CrossLaps were measured at baseline, 1 week, 2 weeks, 6 weeks, 3 months, and 1 year. We included the results of the dropped-out patients in the intention to treat analysis. There was no difference between treatment groups in bone mineral density, histomorphometric estimations, and changes in bone biomarkers. These findings may offer an indication of ibuprofen as a bone-safe analgesic treatment in an acute fracture-phase. © 2019 Orthopaedic Research Society. Published by Wiley Periodicals, Inc. J Orthop Res 38:545-554, 2020.",2020,"There was no difference between treatment groups in bone mineral density, histomorphometric estimations and changes in bone biomarkers.","[""after Colles' fracture "", ""Ninety-five patients (eighty females) with displaced Colles' fracture, median age 65 (range 40-85) years were included in the study and operated on by external fixation from June 2012 through to June 2015"", '89 patients received']","['interventional medicine', 'ibuprofen', 'placebo', '3-days ibuprofen', 'Nonsteroidal anti-inflammatory drugs (NSAIDs']","['biomarkers Osteocalcin and CrossLaps', 'bone mineral density, turnover biomarkers, and histomorphometric characteristics', 'callus tissue volume- and surface fractions', 'bone healing', 'bone mineral density, histomorphometric estimations and changes in bone biomarkers', 'bone mineral density between the ultra-distal region of the injured and non-injured radius']","[{'cui': 'C0009353', 'cui_str': ""Colles' Fracture""}, {'cui': 'C4517906', 'cui_str': '95'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0012727', 'cui_str': 'Displacement (morphologic abnormality)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0407333', 'cui_str': 'Fixation of fracture using external fixator (procedure)'}, {'cui': 'C0332273', 'cui_str': 'Through (qualifier value)'}]","[{'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C0020740', 'cui_str': 'Ibuprofen'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0003211', 'cui_str': 'Anti Inflammatory Agents, Nonsteroidal'}]","[{'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0373691', 'cui_str': 'Osteocalcin measurement (procedure)'}, {'cui': 'C0671677', 'cui_str': 'CrossLaps peptide'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0443331', 'cui_str': 'Turnover technique (qualifier value)'}, {'cui': 'C0376154', 'cui_str': 'Callosities'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0205148', 'cui_str': 'Surface (attribute)'}, {'cui': 'C1264633', 'cui_str': 'Fractions of (qualifier value)'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0043240', 'cui_str': 'Wound Healing'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0205108', 'cui_str': 'Distal (qualifier value)'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C1306504', 'cui_str': 'Radius (qualifier value)'}]",95.0,0.441613,"There was no difference between treatment groups in bone mineral density, histomorphometric estimations and changes in bone biomarkers.","[{'ForeName': 'Marius', 'Initials': 'M', 'LastName': 'Aliuskevicius', 'Affiliation': 'Department of Orthopedic Surgery, Clinic Orto-Head, Aalborg University Hospital, 18-22 Hobrovej, DK-9000, Aalborg, Denmark.'}, {'ForeName': 'Svend Erik', 'Initials': 'SE', 'LastName': 'Østgaard', 'Affiliation': 'Department of Orthopedic Surgery, Clinic Orto-Head, Aalborg University Hospital, 18-22 Hobrovej, DK-9000, Aalborg, Denmark.'}, {'ForeName': 'Ellen Margrethe', 'Initials': 'EM', 'LastName': 'Hauge', 'Affiliation': 'Department of Rheumatology, Aarhus University Hospital, 99 Palle Juul-Jensens Boulevard, DK-8200, Aarhus N, Denmark.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Vestergaard', 'Affiliation': 'Department of Clinical Medicine, Aalborg University, 15 Sdr. Skovvej, DK-9000, Aalborg, Denmark.'}, {'ForeName': 'Sten', 'Initials': 'S', 'LastName': 'Rasmussen', 'Affiliation': 'Department of Orthopedic Surgery, Clinic Orto-Head, Aalborg University Hospital, 18-22 Hobrovej, DK-9000, Aalborg, Denmark.'}]",Journal of orthopaedic research : official publication of the Orthopaedic Research Society,['10.1002/jor.24498'] 1188,32407835,An anti-IL-13 antibody reverses epithelial-mesenchymal transition biomarkers in eosinophilic esophagitis: Phase 2 trial results.,"BACKGROUND Fibrostenosis, the most serious eosinophilic esophagitis (EoE) complication, is mediated by epithelial-mesenchymal transition (EMT). Transitioned cells contribute to pathogenesis by overproducing extracellular matrix. OBJECTIVE Our aim was to determine whether RPC4046 (anti‒IL-13 mAb) modulates EMT biomarkers in biopsy samples from adults with active EoE in a substudy of a double-blind, placebo-controlled phase 2 trial. METHODS Baseline and week 16 esophageal biopsy samples were taken from 69 patients who were randomized to weekly treatment with subcutaneous RPC4046, 180 mg (n = 19), 360 mg (n = 26), or placebo (n = 24). Duplex immunofluorescence slides stained for E-cadherin and vimentin were digitally analyzed by mapping each epithelial cell and recording fluorescence intensities. End points included change from baseline to week 16 in percentage of vimentin-positive epithelial cells (primary), total E-cadherin expression, and vimentin-to-E-cadherin ratio per cell (an average of 47,000 cells per biopsy sample analyzed). RESULTS The mean percentage of vimentin-positive cells decreased by 0.94%, 2.75%, and 4.24% in the placebo, low-dose, and high-dose groups, respectively (P =.032 for the high-dose vs placebo group). Mean E-cadherin expression per cell increased 5.6-fold in both dose groups versus in the placebo group (high-dose group P = .047). The increases in E-cadherin expression per cell from baseline to week 16 were correlated with improvements in histology, eosinophil counts, endoscopic findings, and symptoms. CONCLUSION RPC4046 significantly reduced EMT markers in adults with active EoE, with greater effects at 360 mg. Together with results for eosinophil density and clinical end points from the main trial, these data support the hypothesis that pharmacologic IL-13 inhibition ameliorates both inflammatory and remodeling pathways and could potentially reduce the risk of fibrostenotic complications.",2020,"Increases in e-cadherin per cell from baseline to week 16 were correlated with improvements in histology, eosinophil counts, endoscopic findings, and symptoms. ","['biopsies from adults with active EoE', 'eosinophilic esophagitis']","['subcutaneous RPC4046', 'RPC4046', 'RPC4046 (anti‒IL-13 monoclonal antibody', 'placebo']","['EMT markers', 'Mean e-cadherin expression per cell', 'percentage vimentin-positive epithelial cells (primary), total e-cadherin, and vimentin:e-cadherin ratio per cell (average of 47,000 cells/biopsy analyzed', 'histology, eosinophil counts, endoscopic findings, and symptoms', 'Mean percentage vimentin-positive cells']","[{'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0341106', 'cui_str': 'Eosinophilic esophagitis'}]","[{'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C4547951', 'cui_str': 'RPC4046'}, {'cui': 'C0003250', 'cui_str': 'Monoclonal antibody'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1523298', 'cui_str': 'Epithelial-Mesenchymal Transformation'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0042172', 'cui_str': 'E-Cadherin'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0042666', 'cui_str': 'Vimentin'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0014597', 'cui_str': 'Epithelial cell'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0019638', 'cui_str': 'Histology'}, {'cui': 'C0200638', 'cui_str': 'Eosinophil count'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0439178', 'cui_str': '% positive cells'}]",69.0,0.430787,"Increases in e-cadherin per cell from baseline to week 16 were correlated with improvements in histology, eosinophil counts, endoscopic findings, and symptoms. ","[{'ForeName': 'Peter H', 'Initials': 'PH', 'LastName': 'Gann', 'Affiliation': 'Department of Pathology, University of Illinois College of Medicine, Chicago, Ill. Electronic address: pgann@uic.edu.'}, {'ForeName': 'Ryan J', 'Initials': 'RJ', 'LastName': 'Deaton', 'Affiliation': 'Department of Pathology, University of Illinois College of Medicine, Chicago, Ill.'}, {'ForeName': 'Nathan', 'Initials': 'N', 'LastName': 'McMahon', 'Affiliation': 'Department of Pathology, University of Illinois College of Medicine, Chicago, Ill.'}, {'ForeName': 'Margaret H', 'Initials': 'MH', 'LastName': 'Collins', 'Affiliation': ""Division of Pathology and Laboratory Medicine, Cincinnati Children's Hospital Medical Center, University of Cincinnati College of Medicine, Cincinnati, Ohio.""}, {'ForeName': 'Evan S', 'Initials': 'ES', 'LastName': 'Dellon', 'Affiliation': 'Department of Medicine, University of North Carolina School of Medicine, Chapel Hill, NC.'}, {'ForeName': 'Ikuo', 'Initials': 'I', 'LastName': 'Hirano', 'Affiliation': 'Northwestern University, Feinberg School of Medicine, Chicago, Ill.'}, {'ForeName': 'Steven Ye', 'Initials': 'SY', 'LastName': 'Hua', 'Affiliation': 'Celgene Corporation, Summit, NJ.'}, {'ForeName': 'Cristian', 'Initials': 'C', 'LastName': 'Rodriguez', 'Affiliation': 'Celgene Corporation, Summit, NJ.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Harris', 'Affiliation': 'Celgene Corporation, Summit, NJ.'}]",The Journal of allergy and clinical immunology,['10.1016/j.jaci.2020.03.045'] 1189,30392581,Randomized controlled trial of brain specific fatty acid supplementation in pregnant women increases brain volumes on MRI scans of their newborn infants.,"Docosahexaenoic acid (DHA) and arachidonic acid (ArA) are essential brain specific fatty acids (BSFA) for mammalian central nervous system development. Human brains have accelerated growth with significant increase in cerebral content of ArA and DHA during the last trimester of pregnancy and first postnatal months. This randomized double blind placebo controlled single centre trial assessed the impact of BSFA supplementation in pregnancy on newborn infants' brain volumes. Eighty six infants born to study mothers had brain magnetic resonance imaging (MRI) scans soon after birth. Total and regional brain volumes were analyzed and related to maternal supplementation group. Males born to the BSFA supplemented mothers had significantly larger total brain volumes, total gray matter, corpus callosum and cortical volumes when compared to the placebo group. This is the first study to show maternal BSFA supplementation enhances newborn infants' brain size and suggests differential sex sensitivity of fetal brains to pregnancy BSFA status.",2018,"Males born to the BSFA supplemented mothers had significantly larger total brain volumes, total gray matter, corpus callosum and cortical volumes when compared to the placebo group.","['pregnant women increases brain volumes on MRI scans of their newborn infants', 'Eighty six infants born to study mothers had brain magnetic resonance imaging (MRI) scans soon after birth', ""newborn infants' brain volumes""]","['placebo', 'Docosahexaenoic acid (DHA) and arachidonic acid (ArA', 'maternal BSFA supplementation', 'BSFA supplementation', 'brain specific fatty acid supplementation', 'BSFA']","['larger total brain volumes, total gray matter, corpus callosum and cortical volumes', 'cerebral content of ArA and DHA', 'Total and regional brain volumes']","[{'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0917711', 'cui_str': 'MRI Scans'}, {'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C1552358', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0441633'}, {'cui': 'C0005615', 'cui_str': 'Birth'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0556150', 'cui_str': 'docosahexaenoic acid'}, {'cui': 'C0003701', 'cui_str': 'Arachidonic Acids'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0015684', 'cui_str': 'Fatty Acids'}]","[{'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0018220', 'cui_str': 'Gray Matter'}, {'cui': 'C0010090', 'cui_str': 'Neocortical Commissure'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}]",86.0,0.187957,"Males born to the BSFA supplemented mothers had significantly larger total brain volumes, total gray matter, corpus callosum and cortical volumes when compared to the placebo group.","[{'ForeName': 'E', 'Initials': 'E', 'LastName': 'Ogundipe', 'Affiliation': 'Neonatal Department, Imperial College London, Chelsea & Westminster Hospital London, UK; Lipid laboratory, Department of Medicine, Imperial College London, Chelsea & Westminster Hospital campus, London, UK. Electronic address: e.ogundipe@imperial.ac.uk.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Tusor', 'Affiliation': ""F Med Sci, Perinatal Neuroimaging Unit, King's College London, UK. Electronic address: n.tusor@kcl.ac.uk.""}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Lipid laboratory, Department of Medicine, Imperial College London, Chelsea & Westminster Hospital campus, London, UK. Electronic address: yiqun.wang@imperial.ac.uk.'}, {'ForeName': 'M R', 'Initials': 'MR', 'LastName': 'Johnson', 'Affiliation': 'Academic Obstetric Department, Imperial College London, Chelsea & Westminster Hospital campus, London, UK. Electronic address: mark.johnson@imperial.ac.uk.'}, {'ForeName': 'A D', 'Initials': 'AD', 'LastName': 'Edwards', 'Affiliation': ""F Med Sci, Perinatal Neuroimaging Unit, King's College London, UK. Electronic address: ad.edwards@kcl.ac.uk.""}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Crawford', 'Affiliation': 'Academic Obstetric Department, Imperial College London, Chelsea & Westminster Hospital campus, London, UK. Electronic address: michael.crawford@imperial.ac.uk.'}]","Prostaglandins, leukotrienes, and essential fatty acids",['10.1016/j.plefa.2018.09.001'] 1190,31422655,"Comparing Bupivacaine, Lidocaine, and a Combination of Bupivacaine and Lidocaine for Labor Epidural Activation: A Prospective, Randomized, Double-Blind Study","Objective Epidural anesthesia for the parturient is often provided in a clinical context where rapid onset of segmental analgesia is important; however, little is published on the ideal local anesthetic to safely achieve this onset. To fi ll this gap in knowledge, we studied bupivacaine and lidocaine, two local anesthetics (LA) commonly used for labor epidural activation, either as a single drug or in combination to determine the onset of epidural analgesia. Methods In this double-blinded study, seventy-five patients were randomized into three groups (n = 25 each) for labor epidural activation: 10 mL of 0.25% bupivacaine, 10 mL of 1% lidocaine, or 5 mL of 0.25% bupivacaine plus 5 mL of 1% lidocaine. Patients were assessed for the fi rst 20 min after drug administration at 5-min intervals. Data collected included sensory level to pinprick, maternal blood pressure, vasopressor administration, and peak motor blockade. Results Data were analyzed on 71 of 75 patients. Time to loss of sensation to pinprick at the T10 dermatome in the bupivacaine group was signifi cantly longer than the lidocaine group (p = 0.006), but the time to loss of sensation to pinprick at the T10 dermatome did not signifi cantly differ in the bupivacaine plus lidocaine group when compared to both the bupivacaine (p = 0.114) as well as the lidocaine (p = 0.203) groups. Phenylephrine usage did not signifi cantly differ amongst the three groups (p = 0.062). Conclusion Lidocaine provides statistically signifi cant faster onset of epidural analgesia when compared to bupivacaine only. Combining the two LA did not signifi cantly affect onset.",2019,"Phenylephrine usage did not signifi cantly differ amongst the three groups (p = 0.062). ","['Labor Epidural Activation', 'seventy-five patients']","['labor epidural activation: 10 mL of 0.25% bupivacaine, 10 mL of 1% lidocaine, or 5 mL of 0.25% bupivacaine plus 5 mL of 1% lidocaine', 'bupivacaine plus lidocaine', 'Phenylephrine', 'bupivacaine and lidocaine, two local anesthetics (LA', 'Bupivacaine and Lidocaine', 'Lidocaine', 'Bupivacaine, Lidocaine', 'bupivacaine', 'lidocaine']","['Time to loss of sensation to pinprick', 'time to loss of sensation to pinprick', 'sensory level to pinprick, maternal blood pressure, vasopressor administration, and peak motor blockade']","[{'cui': 'C0022864', 'cui_str': 'Labor, Obstetric'}, {'cui': 'C4319621', 'cui_str': 'Seventy-five'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0022864', 'cui_str': 'Labor, Obstetric'}, {'cui': 'C4517443', 'cui_str': '0.25 (qualifier value)'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0031469', 'cui_str': 'Phenylephrine'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia (procedure)'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0028643', 'cui_str': 'Numbness (finding)'}, {'cui': 'C1262068', 'cui_str': 'Sensory level'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C3540676', 'cui_str': 'Blockade'}]",75.0,0.116881,"Phenylephrine usage did not signifi cantly differ amongst the three groups (p = 0.062). ","[{'ForeName': 'Mark F.', 'Initials': 'MF', 'LastName': 'Powell', 'Affiliation': 'Department of Anesthesiology and Perioperative Medicine, University of Alabama at Birmingham, Birmingham, USA'}, {'ForeName': 'Kristin W.', 'Initials': 'KW', 'LastName': 'Jarzombek', 'Affiliation': 'Department of Anesthesiology and Perioperative Medicine, University of Alabama at Birmingham, Birmingham, USA'}, {'ForeName': 'Kenton J.', 'Initials': 'KJ', 'LastName': 'Venhuizen', 'Affiliation': 'Department of Anesthesiology and Perioperative Medicine, University of Alabama at Birmingham, Birmingham, USA'}, {'ForeName': 'Michelle D.', 'Initials': 'MD', 'LastName': 'Tubinis', 'Affiliation': 'Department of Anesthesiology and Perioperative Medicine, University of Alabama at Birmingham, Birmingham, USA'}, {'ForeName': 'Charity J.', 'Initials': 'CJ', 'LastName': 'Morgan', 'Affiliation': 'Department of Anesthesiology and Perioperative Medicine, University of Alabama at Birmingham, Birmingham, USA'}, {'ForeName': 'Michael A.', 'Initials': 'MA', 'LastName': 'Frölich', 'Affiliation': 'Department of Anesthesiology and Perioperative Medicine, University of Alabama at Birmingham, Birmingham, USA'}]",Asian journal of anesthesiology,['10.6859/aja.201906_57(2).0004'] 1191,31656165,Retroclavicular vs Infraclavicular block for brachial plexus anesthesia: a multi-centric randomized trial.,"BACKGROUND The coracoid approach is a simple method to perform ultrasound-guided brachial plexus regional anesthesia (RA) but its simplicity is counterbalanced by a difficult needle visualization. We hypothesized that the retroclavicular (RCB) approach is not longer to perform when compared to the coracoid (ICB) approach, and improves needle visualization. METHODS This randomized, controlled, non-inferiority trial conducted in two hospitals, included patients undergoing distal upper limb surgery. Patients were randomly assigned to a brachial plexus block (ICB or RCB). The primary outcome was performance time (sum of visualization and needling time), and was analyzed with a non-inferiority test of averages. Depth of sensory and motor blockade, surgical success, total anesthesia time, needle visualization, number of needle passes and complications were also evaluated. Subgroup analysis restricted to patients with higher body mass index was completed. RESULTS We included 109 patients between September 2016 and May 2017. Mean RCB performance time was 4.8 ± 2.0 min while ICB was 5.2 ± 2.3 min (p = 0.06) with a 95% CI reaching up to 5.8% longer. RCB conferred an ultrasound-needle angle closer to 0° and significantly improved needle visibility after the clavicle was cleared and before local anesthetic administration. No differences were found in the secondary outcomes. Similar results were found in the subgroup analysis. CONCLUSION RCB approach for brachial plexus anesthesia was similar to ICB approach in terms of time performance. Needle visibility, which represent an important clinical variable, was superior and angle between needle and ultrasound probe was close to 0° in the RCB group. CLINICAL TRIAL REGISTRATION ClinicalTrials.gov (NCT02913625), registered 26 September 2016.",2019,No differences were found in the secondary outcomes.,"['two hospitals, included patients undergoing distal upper limb surgery', 'brachial plexus anesthesia', '109 patients between September 2016 and May 2017']","['RCB', 'brachial plexus block (ICB or RCB', 'retroclavicular (RCB) approach', 'Retroclavicular vs Infraclavicular block']","['performance time (sum of visualization and needling time), and was analyzed with a non-inferiority test of averages', 'Depth of sensory and motor blockade, surgical success, total anesthesia time, needle visualization, number of needle passes and complications', 'Mean RCB performance time', 'needle visibility']","[{'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205108', 'cui_str': 'Distal (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0394697', 'cui_str': 'Brachial Plexus Anesthesia'}]","[{'cui': 'C0394697', 'cui_str': 'Brachial Plexus Anesthesia'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0445254', 'cui_str': 'Sensory (qualifier value)'}, {'cui': 'C3540676', 'cui_str': 'Blockade'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C0398296', 'cui_str': 'Cannulation of vascular fistula, graft or prosthetic device (procedure)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",109.0,0.151704,No differences were found in the secondary outcomes.,"[{'ForeName': 'Andrés Felipe Gil', 'Initials': 'AFG', 'LastName': 'Blanco', 'Affiliation': 'Department of Anesthesiology, Medicine and Health Sciences Faculty, Centre Hospitalier Universitaire de Sherbrooke (CHUS), 3001, 12e Avenue Nord, Sherbrooke, QC, J1H 5N4, Canada.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Laferrière-Langlois', 'Affiliation': 'Department of Anesthesiology, Medicine and Health Sciences Faculty, Centre Hospitalier Universitaire de Sherbrooke (CHUS), 3001, 12e Avenue Nord, Sherbrooke, QC, J1H 5N4, Canada.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Jessop', 'Affiliation': 'Department of Anesthesiology, Medicine and Health Sciences Faculty, Centre Hospitalier Universitaire de Laval (CHUL), 2705 boul Laurier, Quebec, G1V 4G2, QC, Canada.'}, {'ForeName': 'Frédérick', 'Initials': 'F', 'LastName': ""D'Aragon"", 'Affiliation': 'Department of Anesthesiology, Medicine and Health Sciences Faculty, Centre Hospitalier Universitaire de Sherbrooke (CHUS), 3001, 12e Avenue Nord, Sherbrooke, QC, J1H 5N4, Canada.'}, {'ForeName': 'Yanick', 'Initials': 'Y', 'LastName': 'Sansoucy', 'Affiliation': 'Department of Anesthesiology, Medicine and Health Sciences Faculty, Centre Hospitalier Universitaire de Sherbrooke (CHUS), 3001, 12e Avenue Nord, Sherbrooke, QC, J1H 5N4, Canada.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Albert', 'Affiliation': 'Department of Anesthesiology, Medicine and Health Sciences Faculty, Centre Hospitalier Universitaire de Laval (CHUL), 2705 boul Laurier, Quebec, G1V 4G2, QC, Canada.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Tétreault', 'Affiliation': 'Department of Biomedical Engineering, Faculty of medicine and Dentistry, University of Alberta, 1098 Research Transition Facility, Edmonton, T6G 2V2, AB, Canada.'}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Echave', 'Affiliation': 'Department of Anesthesiology, Medicine and Health Sciences Faculty, Centre Hospitalier Universitaire de Sherbrooke (CHUS), 3001, 12e Avenue Nord, Sherbrooke, QC, J1H 5N4, Canada. Pablo.Echave@USherbrooke.ca.'}]",BMC anesthesiology,['10.1186/s12871-019-0868-6'] 1192,30507211,A randomized trial of culturally accommodated versus standard group treatment for Latina/o adolescents with substance use disorders: Posttreatment through 12-month outcomes.,"OBJECTIVES Latina/o adolescents are at particular risk for substance use disorders (SUDs) and effective treatments are needed. Some critics indicate that standard evidence-based treatments may not meet the needs of Latina/o adolescents and culturally accommodated treatments are needed; however, few comparative studies have been conducted to test this assumption. This randomized trial was designed to test a standard group-based version of a cognitive-behavioral treatment (S-CBT) against its culturally accommodated equivalent (A-CBT) for a sample of Latina/o adolescents with SUDs. METHOD Seventy Latina/o adolescents were randomly assigned to 1 of 2 treatment conditions and followed over 4 posttreatment time points with the last at 12-months. Generalized longitudinal mixed models for count data were conducted to evaluate treatment differences across time for adolescent substance use. The cultural variables ethnic identity, acculturation, and familism were included in the analysis as potential moderators of treatment outcome. RESULTS A significant difference was found at the 12-month follow-up in favor of the culturally accommodated treatment (d = .92, 95% confidence interval, CI [.43, 1.42]) and parental familism moderated treatment outcome (d = .60, 95% CI [.12, 1.08]). CONCLUSION This is one of the first studies to demonstrate that a culturally accommodated treatment differentially improved outcomes compared with that of its standard equivalent for a sample of Latina/o adolescents with SUDs. (PsycINFO Database Record (c) 2019 APA, all rights reserved).",2019,"A significant difference was found at the 12-month follow-up in favor of the culturally accommodated treatment (d = .92, 95% confidence interval, CI [.43, 1.42]) and parental familism moderated treatment outcome (d = .60, 95% CI [.12, 1.08]). ","['Latina', 'Seventy Latina', 'sample of Latina/o adolescents with SUDs', 'o adolescents', 'o adolescents with substance use disorders']",['standard group-based version of a cognitive-behavioral treatment (S-CBT) against its culturally accommodated equivalent (A-CBT'],[],"[{'cui': 'C0949335', 'cui_str': 'Latinas'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0038586', 'cui_str': 'Substance Use Disorders'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}]",[],,0.0533434,"A significant difference was found at the 12-month follow-up in favor of the culturally accommodated treatment (d = .92, 95% confidence interval, CI [.43, 1.42]) and parental familism moderated treatment outcome (d = .60, 95% CI [.12, 1.08]). ","[{'ForeName': 'Jason J', 'Initials': 'JJ', 'LastName': 'Burrow-Sánchez', 'Affiliation': 'Department of Educational Psychology, University of Utah.'}, {'ForeName': 'Hyman', 'Initials': 'H', 'LastName': 'Hops', 'Affiliation': 'Oregon Research Institute.'}]",Cultural diversity & ethnic minority psychology,['10.1037/cdp0000249'] 1193,30500065,Use of an alternative method to evaluate erythema severity in a clinical trial: difference in vehicle response with evaluation of baseline and postdose photographs for effect of oxymetazoline cream 1·0% for persistent erythema of rosacea in a phase IV study.,"BACKGROUND Once-daily topical oxymetazoline cream 1·0% significantly reduced persistent facial erythema of rosacea in trials requiring live, static patient assessments. OBJECTIVES To evaluate critically the methodology of clinical trials that require live, static patient assessments by determining whether assessment of erythema is different when reference to the baseline photograph is allowed. METHODS In two identically designed, randomized, phase III trials, adults with persistent facial erythema of rosacea applied oxymetazoline or vehicle once daily. This phase IV study evaluated standardized digital facial photographs from the phase III trials to record ≥ 1-grade Clinician Erythema Assessment (CEA) improvement at 1, 3, 6, 9 and 12 h postdose. RESULTS Among 835 patients (oxymetazoline n = 415, vehicle n = 420), significantly greater proportions of patients treated with oxymetazoline vs. vehicle achieved ≥ 1-grade CEA improvement. For the comparison between phase IV study results and the original phase III analysis, when reference to baseline photographs was allowed while evaluating post-treatment photographs, the results for oxymetazoline were similar to results of the phase III trials (up to 85.7%), but a significantly lower proportion of vehicle recipients achieved ≥ 1-grade CEA improvement (up to 29.7% [phase 4] vs. 52.3% [phase 3]; P<0.001). In the phase IV study, up to 80·2% of patients treated with oxymetazoline achieved at least moderate erythema improvement vs. up to 22·9% of patients treated with vehicle. The association between patients' satisfaction with facial skin redness and percentage of erythema improvement was statistically significant. CONCLUSIONS Assessment of study photographs, with comparison to baseline, confirmed significant erythema reduction with oxymetazoline on the first day of application. Compared with the phase III trial results, significantly fewer vehicle recipients attained ≥ 1-grade CEA improvement, suggesting a mitigated vehicle effect. This methodology may improve the accuracy of clinical trials evaluating erythema severity.",2019,CEA improvement (up to 29.7% [phase 4] vs. 52.3%,"['adults with persistent facial erythema of rosacea applied oxymetazoline or vehicle once daily', '835 patients (oxymetazoline n\xa0=\xa0415, vehicle n\xa0=\xa0420']","['oxymetazoline', 'oxymetazoline cream', 'oxymetazoline vs. vehicle achieved ≥\xa01-grade']","['persistent facial erythema of rosacea', 'facial skin redness and percentage of erythema improvement', 'persistent erythema of rosacea', 'CEA improvement', 'Clinician Erythema Assessment (CEA) improvement']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0035854', 'cui_str': 'Rosacea'}, {'cui': 'C0030071', 'cui_str': 'Oxymetazoline'}, {'cui': 'C0042444', 'cui_str': 'Drug vehicle (substance)'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4517772', 'cui_str': 'Four hundred and fifteen'}, {'cui': 'C4517774', 'cui_str': 'Four hundred and twenty'}]","[{'cui': 'C0030071', 'cui_str': 'Oxymetazoline'}, {'cui': 'C1378128', 'cui_str': 'Cream'}, {'cui': 'C0042444', 'cui_str': 'Drug vehicle (substance)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}]","[{'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0035854', 'cui_str': 'Rosacea'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0332575', 'cui_str': 'Red color (finding)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]",835.0,0.106335,CEA improvement (up to 29.7% [phase 4] vs. 52.3%,"[{'ForeName': 'L F', 'Initials': 'LF', 'LastName': 'Eichenfield', 'Affiliation': 'University of California, San Diego, CA, U.S.A.'}, {'ForeName': 'J Q', 'Initials': 'JQ', 'LastName': 'Del Rosso', 'Affiliation': 'JDR Dermatology Research/Thomas Dermatology, Las Vegas, NV, U.S.A.'}, {'ForeName': 'J K L', 'Initials': 'JKL', 'LastName': 'Tan', 'Affiliation': 'Windsor Clinical Research Inc., Windsor, ON, Canada.'}, {'ForeName': 'A A', 'Initials': 'AA', 'LastName': 'Hebert', 'Affiliation': 'UTHealth McGovern Medical School, Department of Dermatology, Houston, TX, U.S.A.'}, {'ForeName': 'G F', 'Initials': 'GF', 'LastName': 'Webster', 'Affiliation': 'Webster Dermatology, P.A., Hockessin, DE, U.S.A.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Harper', 'Affiliation': 'Dermatology and Skin Care Center of Birmingham, Birmingham, AL, U.S.A.'}, {'ForeName': 'H E', 'Initials': 'HE', 'LastName': 'Baldwin', 'Affiliation': 'The Acne Treatment and Research Center, Morristown, NJ, U.S.A.'}, {'ForeName': 'L H', 'Initials': 'LH', 'LastName': 'Kircik', 'Affiliation': 'DermResearch, PLLC, Louisville, KY, U.S.A.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Stein-Gold', 'Affiliation': 'Henry Ford Health System, West Bloomfield, MI, U.S.A.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Kaoukhov', 'Affiliation': 'Allergan plc, Irvine, CA, U.S.A.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Alvandi', 'Affiliation': 'Allergan plc, Irvine, CA, U.S.A.'}]",The British journal of dermatology,['10.1111/bjd.17462'] 1194,30430580,Effects of a mental fitness positive psychology intervention program on inpatients with schizophrenia in South Korea: A feasibility study.,"PURPOSE This study investigated the effects of a mental fitness positive psychology intervention program on the self-esteem and interpersonal relationship ability of inpatients with schizophrenia. DESIGN AND METHODS A pretest-posttest nonequivalent control group quasi-experimental design was used. Participants (N = 60) completed scales measuring self-esteem and interpersonal relationship ability. FINDINGS The program effectively improved participants' self-esteem and interpersonal relationship ability. PRACTICE IMPLICATIONS Psychiatric nurses can use this program as a nursing intervention to enhance the self-esteem and interpersonal skills of inpatients with schizophrenia in mental health facilities.",2020,Psychiatric nurses can use this program as a nursing intervention to enhance the self-esteem and interpersonal skills of inpatients with schizophrenia in mental health facilities.,"['Psychiatric nurses', 'inpatients with schizophrenia', 'inpatients with schizophrenia in mental health facilities', 'inpatients with schizophrenia in South Korea']",['mental fitness positive psychology intervention program'],"['scales measuring self-esteem and interpersonal relationship ability', ""participants' self-esteem and interpersonal relationship ability""]","[{'cui': 'C1964024', 'cui_str': 'Mental health nurse (occupation)'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0022773', 'cui_str': 'South Korea'}]","[{'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0033909', 'cui_str': 'Psychology'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0222045'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0036597', 'cui_str': 'Self Esteem'}, {'cui': 'C0439849', 'cui_str': 'Relationships (qualifier value)'}, {'cui': 'C0085732', 'cui_str': 'Ability'}]",,0.0191955,Psychiatric nurses can use this program as a nursing intervention to enhance the self-esteem and interpersonal skills of inpatients with schizophrenia in mental health facilities.,"[{'ForeName': 'Se Jin', 'Initials': 'SJ', 'LastName': 'Kang', 'Affiliation': 'Department of Nursing, Sungil Mental Hospital, Namwon-si, Republic of Korea.'}, {'ForeName': 'Sung Hee', 'Initials': 'SH', 'LastName': 'Ko', 'Affiliation': 'Department of Nursing, Chonbuk Research Institute of Nursing Science, Chonbuk National University, Jeonju-si, Republic of Korea.'}, {'ForeName': 'Ji Young', 'Initials': 'JY', 'LastName': 'Kim', 'Affiliation': 'Department of Nursing, Chonbuk Research Institute of Nursing Science, Chonbuk National University, Jeonju-si, Republic of Korea.'}, {'ForeName': 'Sung Reul', 'Initials': 'SR', 'LastName': 'Kim', 'Affiliation': 'Department of Nursing, Korea University, Seoul, Republic of Korea.'}]",Perspectives in psychiatric care,['10.1111/ppc.12332'] 1195,30563818,"Testing the Efficacy of a Social Networking Gamification App to Improve Pre-Exposure Prophylaxis Adherence (P3: Prepared, Protected, emPowered): Protocol for a Randomized Controlled Trial.","BACKGROUND HIV prevalence is high among young men who have sex with men (YMSM) and young transgender women who have sex with men (YTWSM), particularly among minorities. Despite its proven efficacy and safety, the uptake of and adherence to pre-exposure prophylaxis (PrEP) among YMSM and YTWSM is currently limited. To date, evidence-based interventions to promote and sustain PrEP adherence have been limited and not shown to be highly efficacious. Given the widespread adoption of smartphones, mobile apps can be utilized to increase PrEP adherence for many YMSM and YTWSM. OBJECTIVE The study consists of a formative research phase to develop an app-based intervention, P3 (Prepared, Protected, emPowered), to increase PrEP adherence, and a randomized controlled trial (RCT) to test its efficacy. P3 is a mobile app built on an established health platform, which includes social networking and game-based components to encourage PrEP adherence among YMSM and YTWSM. P3+ includes all P3 features plus adherence counseling delivered via two-way text messaging (short message service, SMS) through the app. METHODS The formative research phase includes usability testing to assess users' comprehension of P3's educational content, understanding and use of intervention features, and overall impressions of app functionality, followed by app refinements. A subsequent field trial will identify and resolve any remaining technical challenges. A three-arm RCT (P3, P3+, and standard of care) will then be conducted at 6 iTech subject recruitment venues to assess intervention efficacy and to conduct a comparison of costs to deliver the 2 intervention arms. RESULTS This is an ongoing research project with initial results from the formative work expected in 2020 and those from the RCT in 2021. CONCLUSIONS P3 aims to provide an engaging, interactive experience that is highly appealing for the target population, leveraging technology already heavily integrated into the lives of young people, and thus meeting users' needs in a familiar, stimulating way. If efficacious, P3 could be a sustainable, easily disseminated, lower-cost PrEP intervention for YMSM and YTWSM. Further, the research aims to determine the processes that are essential to developing and implementing future health-related gamification interventions. TRIAL REGISTRATION ClinicalTrials.gov NCT03320512; https://clinicaltrials.gov/ct2/show/NCT03320512 (Archived by WebCite at http://www.webcitation.org/74OVZkICl). INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID) DERR1-10.2196/10448.",2018,"If efficacious, P3 could be a sustainable, easily disseminated, lower-cost PrEP intervention for YMSM and YTWSM.","['young men who have sex with men (YMSM) and young transgender women who have sex with men (YTWSM), particularly among minorities']","['Pre-Exposure Prophylaxis Adherence (P3', 'Social Networking Gamification App']",['PrEP adherence'],"[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}, {'cui': 'C1319927', 'cui_str': 'Male-to-female transsexual'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C3850098', 'cui_str': 'Pre-Exposure Prophylaxis (PrEP)'}, {'cui': 'C3179002', 'cui_str': 'Social Networking'}]",[],,0.156304,"If efficacious, P3 could be a sustainable, easily disseminated, lower-cost PrEP intervention for YMSM and YTWSM.","[{'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'LeGrand', 'Affiliation': 'Center for Health Policy and Inequalities Research, Duke Global Health Institute, Duke University, Durham, NC, United States.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Knudtson', 'Affiliation': 'Behavior and Technology Lab, Institute for Global Health and Infectious Diseases, University of North Carolina at Chapel Hill, Chapel Hill, NC, United States.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Benkeser', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Rollins School of Public Health, Emory University, Atlanta, GA, United States.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Muessig', 'Affiliation': 'Department of Health Behavior, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, NC, United States.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Mcgee', 'Affiliation': 'Behavior and Technology Lab, Institute for Global Health and Infectious Diseases, University of North Carolina at Chapel Hill, Chapel Hill, NC, United States.'}, {'ForeName': 'Patrick S', 'Initials': 'PS', 'LastName': 'Sullivan', 'Affiliation': 'Department of Epidemiology, Rollins School of Public Health, Emory University, Atlanta, GA, United States.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Hightow-Weidman', 'Affiliation': 'Behavior and Technology Lab, Institute for Global Health and Infectious Diseases, University of North Carolina at Chapel Hill, Chapel Hill, NC, United States.'}]",JMIR research protocols,['10.2196/10448'] 1196,30684076,Empagliflozin for the Treatment of Nonalcoholic Steatohepatitis in Patients with Type 2 Diabetes Mellitus.,"BACKGROUND AND AIMS Sodium-glucose cotransporter-2 (SGLT2) inhibitors are a novel class of drugs that lower glucose by inducing renal glycosuria. We aimed to explore whether SGLT2 inhibitor added to the usual care for patients with type 2 diabetes mellitus (T2DM) and biopsy-proven nonalcoholic steatohepatitis (NASH) will benefit NASH histology. METHODS In this investigator-initiated, single-arm, open-label, pilot study, nine biopsy-proven NASH patients with T2DM were given empagliflozin 25 mg daily for 24 weeks. Liver biopsy was repeated at the end of treatment. The histological outcomes were compared with the placebo group of a previous 48-week clinical trial. RESULTS There was a significant reduction in body mass index (median change, Δ = -0.7 kg per m 2 , p = 0.011), waist circumference (Δ = -3 cm, p = 0.033), systolic blood pressure (Δ = -9 mmHg, p = 0.024), diastolic blood pressure (Δ = -6 mmHg, p = 0.033), fasting blood glucose (Δ = -1.7 mmol/L, p = 0.008), total cholesterol (Δ = -0.5 mmol/L, p = 0.011), gamma glutamyl transpeptidase (Δ = -19 U/L, p = 0.013), volumetric liver fat fraction (Δ = -7.8%, p = 0.017), steatosis (Δ = -1, p = 0.014), ballooning (Δ = -1, p = 0.034), and fibrosis (Δ = 0, p = 0.046). All histological components either remained unchanged or improved, except in one patient who had worsening ballooning. Empagliflozin resulted in significantly greater improvements in steatosis (67% vs. 26%, p = 0.025), ballooning (78% vs. 34%, p = 0.024), and fibrosis (44% vs. 6%, p = 0.008) compared with historical placebo. CONCLUSION This pilot study provides primary histological evidence that empagliflozin may be useful for the treatment of NASH. This preliminary finding should prompt larger clinical trials to assess the effectiveness of empagliflozin and other SGLT2 inhibitors for the treatment of NASH in T2DM patients. Trial registry number ClincialTrials.gov number, NCT02964715.",2020,"Empagliflozin resulted in significantly greater improvements in steatosis (67% vs. 26%, p = 0.025), ballooning (78% vs. 34%, p = 0.024), and fibrosis (44% vs. 6%, p = 0.008) compared with historical placebo. ","['Patients with Type 2 Diabetes Mellitus', 'patients with type 2 diabetes mellitus (T2DM) and biopsy-proven nonalcoholic steatohepatitis (NASH) will benefit NASH histology', 'T2DM patients']","['Empagliflozin', 'empagliflozin', 'placebo', 'SGLT2 inhibitor']","['Liver biopsy', 'waist circumference', 'fasting blood glucose', 'total cholesterol', 'steatosis', 'fibrosis', 'volumetric liver fat fraction', 'systolic blood pressure', 'gamma glutamyl transpeptidase', 'body mass index', 'diastolic blood pressure']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0456369', 'cui_str': 'Proven (qualifier value)'}, {'cui': 'C3241937', 'cui_str': 'Nonalcoholic Steatohepatitis'}, {'cui': 'C0344441', 'cui_str': 'Histologic test (procedure)'}]","[{'cui': 'C3490348', 'cui_str': 'empagliflozin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3273807', 'cui_str': 'Gliflozins'}]","[{'cui': 'C0193388', 'cui_str': 'Biopsy of liver (procedure)'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0152254', 'cui_str': 'Fatty degeneration (morphologic abnormality)'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C0445383', 'cui_str': 'Volumetric (qualifier value)'}, {'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C1264633', 'cui_str': 'Fractions of (qualifier value)'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0202035', 'cui_str': 'Gamma glutamyl transferase measurement (procedure)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}]",,0.122103,"Empagliflozin resulted in significantly greater improvements in steatosis (67% vs. 26%, p = 0.025), ballooning (78% vs. 34%, p = 0.024), and fibrosis (44% vs. 6%, p = 0.008) compared with historical placebo. ","[{'ForeName': 'Lee-Lee', 'Initials': 'LL', 'LastName': 'Lai', 'Affiliation': 'Gastroenterology and Hepatology Unit, Department of Medicine, Faculty of Medicine, University of Malaya, 50603, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Shireene Ratna', 'Initials': 'SR', 'LastName': 'Vethakkan', 'Affiliation': 'Endocrine Unit, Department of Medicine, Faculty of Medicine, University of Malaya, 50603, Kuala Lumpur, Malaysia. shireene.vethakkan@gmail.com.'}, {'ForeName': 'Nik Raihan', 'Initials': 'NR', 'LastName': 'Nik Mustapha', 'Affiliation': 'Department of Pathology, Hospital Sultanah Bahiyah, Alor Setar, Kedah, Malaysia.'}, {'ForeName': 'Sanjiv', 'Initials': 'S', 'LastName': 'Mahadeva', 'Affiliation': 'Gastroenterology and Hepatology Unit, Department of Medicine, Faculty of Medicine, University of Malaya, 50603, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Wah-Kheong', 'Initials': 'WK', 'LastName': 'Chan', 'Affiliation': 'Gastroenterology and Hepatology Unit, Department of Medicine, Faculty of Medicine, University of Malaya, 50603, Kuala Lumpur, Malaysia. wahkheong2003@hotmail.com.'}]",Digestive diseases and sciences,['10.1007/s10620-019-5477-1'] 1197,30463434,Comparison of a Smartphone Otoscope and Conventional Otoscope in the Diagnosis and Management of Acute Otitis Media.,"Acute otitis media (AOM) is a leading cause of health encounters and antimicrobial prescriptions in children worldwide. We assessed (1) the rates of antimicrobial prescribing by pediatric emergency department clinicians using a smartphone otoscope device as compared with a conventional otoscope and (2) clinician acceptability of the smartphone device. We conducted a randomized control study in children's hospital emergency departments over 6 months. More than 1500 encounters were analyzed. The odds of prescribing antibiotics after being given a diagnosis of AOM by clinicians assigned to the smartphone group was 11% higher than the conventional group (18.8% vs 18.0%, odds ratio = 1.106, P = .600). Eight (73%) of the 11 physicians in the smartphone group preferred the smartphone device over the conventional otoscope. Use of a smartphone otoscope for detection of AOM in a pediatric emergency department setting did not lead to an increased likelihood of AOM diagnosis.",2019,Use of a smartphone otoscope for detection of AOM in a pediatric emergency department setting did not lead to an increased likelihood of AOM diagnosis.,"['Acute otitis media (AOM', ""children's hospital emergency departments over 6 months"", 'Acute Otitis Media']","['smartphone otoscope', 'Smartphone Otoscope and Conventional Otoscope', 'smartphone otoscope device']","['odds of prescribing antibiotics', 'smartphone device']","[{'cui': 'C0271429', 'cui_str': 'Acute otitis media (disorder)'}, {'cui': 'C0020017', 'cui_str': 'Hospitals, Pediatric'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0182098', 'cui_str': 'Otoscopes'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0220819', 'cui_str': 'devices'}]","[{'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0220819', 'cui_str': 'devices'}]",,0.0406635,Use of a smartphone otoscope for detection of AOM in a pediatric emergency department setting did not lead to an increased likelihood of AOM diagnosis.,"[{'ForeName': 'K Ning', 'Initials': 'KN', 'LastName': 'Chan', 'Affiliation': 'Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Silverstein', 'Affiliation': ""Children's Healthcare of Atlanta, Atlanta, GA, USA.""}, {'ForeName': 'Leah N', 'Initials': 'LN', 'LastName': 'Bryan', 'Affiliation': 'Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Courtney E', 'Initials': 'CE', 'LastName': 'McCracken', 'Affiliation': 'Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Wendalyn K', 'Initials': 'WK', 'LastName': 'Little', 'Affiliation': 'Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Andi L', 'Initials': 'AL', 'LastName': 'Shane', 'Affiliation': 'Emory University, Atlanta, GA, USA.'}]",Clinical pediatrics,['10.1177/0009922818812480'] 1198,30694996,"Transcutaneous Electrical Nerve Stimulation on Acupuncture Points Improves Myofascial Pain, Moods, and Sleep Quality.","PURPOSE The aim of this study was to evaluate the effects of transcutaneous electrical nerve stimulation at acupuncture points versus trigger points on myofascial pain, moods, and sleep quality. DESIGN A randomized controlled study recruited 64 patients with spinal cord injury with myofascial pain. METHODS Outcomes of pain, moods, and sleep quality were measured and analyzed by the generalized estimation equation, analysis of covariance, and paired t test. Transcutaneous electrical nerve stimulation was applied for seven consecutive days at Hegu (LI4) and Daling (PC7) acupuncture points or myofascial trigger points. FINDING Significant differences were found in pain intensity from Day 3 forward, after controlling for confounders. Significant within-group differences were found in pain, moods, and sleep quality. CONCLUSIONS Transcutaneous electrical nerve stimulation at acupuncture and trigger points effectively improved pain, moods, and sleep quality in patients with spinal cord injury with myofascial pain. Acupuncture points had superior improvement in pain intensity and slight improvement in sleep quality than did trigger points. CLINICAL RELEVANCE Transcutaneous electrical nerve stimulation at acupuncture points could be applied for improving myofascial pain.",2020,"Significant within-group differences were found in pain, moods, and sleep quality. ","['64 patients with spinal cord injury with myofascial pain', 'patients with spinal cord injury with myofascial pain']","['Transcutaneous Electrical Nerve Stimulation on Acupuncture Points', 'Acupuncture', 'Transcutaneous electrical nerve stimulation was applied for seven consecutive days at Hegu (LI4) and Daling (PC7) acupuncture points or myofascial trigger points', 'transcutaneous electrical nerve stimulation at acupuncture']","['myofascial pain, moods, and sleep quality', 'myofascial pain', 'sleep quality', 'pain intensity', 'pain, moods, and sleep quality', 'Myofascial Pain, Moods, and Sleep Quality']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0037929', 'cui_str': 'Spinal Cord Trauma'}, {'cui': 'C0553642', 'cui_str': 'Non-articular rheumatism (disorder)'}]","[{'cui': 'C0040654', 'cui_str': 'Electric Stimulation, Transcutaneous'}, {'cui': 'C0001302', 'cui_str': 'Acupoints'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0646427', 'cui_str': 'DALES'}, {'cui': 'C0458343', 'cui_str': 'Trigger point (body structure)'}]","[{'cui': 'C0553642', 'cui_str': 'Non-articular rheumatism (disorder)'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",64.0,0.121364,"Significant within-group differences were found in pain, moods, and sleep quality. ","[{'ForeName': 'Yar-Fang', 'Initials': 'YF', 'LastName': 'Chiou', 'Affiliation': 'Department of Nursing, Taipei Veterans General Hospital, Taipei, Taiwan, R.O.C.'}, {'ForeName': 'Mei-Ling', 'Initials': 'ML', 'LastName': 'Yeh', 'Affiliation': 'Graduate Institute of Integration of Traditional Chinese Medicine With Western Nursing, National Taipei University of Nursing and Health Sciences, Taipei, Taiwan, R.O.C.'}, {'ForeName': 'Yu-Jen', 'Initials': 'YJ', 'LastName': 'Wang', 'Affiliation': 'Department of Nursing, Chang Gung University of Science and Technology, Taoyuan, Taiwan, R.O.C.'}]",Rehabilitation nursing : the official journal of the Association of Rehabilitation Nurses,['10.1097/RNJ.0000000000000198'] 1199,32408022,Supporting Syrian families displaced by armed conflict: A pilot randomized controlled trial of the Caregiver Support Intervention.,"BACKGROUND The impact of armed conflict and displacement on children's mental health is strongly mediated by compromised parenting stemming from persistently high caregiver stress. Parenting interventions for refugees emphasize the acquisition of parenting knowledge and skills, while overlooking the deleterious effects of chronic stress on parenting. War Child Holland's Caregiver Support Intervention (CSI) aims to strengthen parenting by lowering stress and improving psychosocial wellbeing among refugee parents, while also increasing knowledge and skill related to positive parenting. The CSI is a nine-session group intervention delivered by non-specialist providers. OBJECTIVE We describe the findings of a two-arm pilot randomized controlled trial of the CSI with Syrian refugees in Lebanon. The primary aim was to test the feasibility of our study methodology prior to conducting a definitive RCT. METHODS We recruited 78 families (151 parents), who were randomized to the CSI or a waitlist control group. Data were collected at baseline and post-intervention. RESULTS Randomization was successful, retention was high (99 %), as was intervention completion (95 % among women, 86 % among men). Implementation fidelity was excellent. Blinding was largely, though not completely effective. The CSI group showed significantly increased parental warmth and responsiveness, decreased harsh parenting, lowered stress and distress, improved psychosocial wellbeing, and improved stress management. CSI parents reported increased child psychosocial wellbeing. Control families showed no significant change on any variable. CONCLUSIONS Findings demonstrate the feasibility of our methodology for a definitive RCT, and suggest that the CSI shows promise as a scalable approach to strengthening parenting in refugee communities. Trial registration # ISRCTN33665023.",2020,"The CSI group showed significantly increased parental warmth and responsiveness, decreased harsh parenting, lowered stress and distress, improved psychosocial wellbeing, and improved stress management.","['78 families (151 parents', ""children's mental health""]","['CSI', 'Caregiver Support Intervention', ""War Child Holland's Caregiver Support Intervention (CSI""]","['parental warmth and responsiveness, decreased harsh parenting, lowered stress and distress, improved psychosocial wellbeing, and improved stress management', 'child psychosocial wellbeing']","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}]","[{'cui': 'C0150162', 'cui_str': 'Caregiver support'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0043027', 'cui_str': 'War'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}]","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0150788', 'cui_str': 'Stress management'}, {'cui': 'C0008059', 'cui_str': 'Child'}]",78.0,0.126032,"The CSI group showed significantly increased parental warmth and responsiveness, decreased harsh parenting, lowered stress and distress, improved psychosocial wellbeing, and improved stress management.","[{'ForeName': 'Kenneth E', 'Initials': 'KE', 'LastName': 'Miller', 'Affiliation': 'War Child Holland, Helmholtzstraat 61g, 1098LE Amsterdam, The Netherlands. Electronic address: Kenneth.Miller@warchild.nl.'}, {'ForeName': 'Gabriela V', 'Initials': 'GV', 'LastName': 'Koppenol-Gonzalez', 'Affiliation': 'War Child Holland, Helmholtzstraat 61g, 1098LE Amsterdam, The Netherlands. Electronic address: Gabriela.Koppenol@warchild.nl.'}, {'ForeName': 'Maguy', 'Initials': 'M', 'LastName': 'Arnous', 'Affiliation': 'War Child Holland, Lebanon. Electronic address: Maguy.Arnous@warchild.nl.'}, {'ForeName': 'Fadila', 'Initials': 'F', 'LastName': 'Tossyeh', 'Affiliation': 'War Child Holland, Lebanon. Electronic address: Fadila.Tossyeh@warchild.nl.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Chen', 'Affiliation': 'Harvard University, United States. Electronic address: Alexandra.chen@post.harvard.edu.'}, {'ForeName': 'Nayla', 'Initials': 'N', 'LastName': 'Nahas', 'Affiliation': 'University of Balamand, Lebanon. Electronic address: Nayla.Nahas@balamand.edu.lb.'}, {'ForeName': 'Mark J D', 'Initials': 'MJD', 'LastName': 'Jordans', 'Affiliation': 'War Child Holland, Helmholtzstraat 61g, 1098LE Amsterdam, The Netherlands; Amsterdam Institute of Social Science Research, University of Amsterdam, The Netherlands. Electronic address: Mark.Jordans@warchild.nl.'}]",Child abuse & neglect,['10.1016/j.chiabu.2020.104512'] 1200,31721979,Occurence of First and Recurrent Major Adverse Cardiovascular Events With Liraglutide Treatment Among Patients With Type 2 Diabetes and High Risk of Cardiovascular Events: A Post Hoc Analysis of a Randomized Clinical Trial.,"Importance After the occurrence of nonfatal cardiovascular events, recurrent events are highly likely. Most cardiovascular outcomes trials analyze first events only; extending analyses to first and recurrent (total) events can provide clinically meaningful information. Objective To investigate whether liraglutide is associated with reduced first and recurrent total major adverse cardiovascular events (MACE) compared with placebo among patients with type 2 diabetes and high risk of cardiovascular events. Design, Setting, and Participants This post hoc analysis of the Liraglutide Effect and Action in Diabetes: Evaluation of Cardiovascular Outcome Results (LEADER) randomized, double-blind, clinical trial included data from patients with type 2 diabetes who had established or were at high risk for cardiovascular disease at 410 sites in 32 countries from August 2010, to December 2015. Data analysis was performed from August 15, 2016, to July 5, 2019. Interventions Patients were randomized 1:1 to receive liraglutide (up to 1.8 mg per day) or placebo, both with standard care, for 3.5 to 5.0 years. Main Outcomes and Measures Assessed outcomes were MACE (cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke), expanded MACE (primary MACE plus coronary revascularization and hospitalization for heart failure or unstable angina pectoris), and the individual end points. Results The 9340 LEADER trial participants (6003 [64.3%] male; mean [SD] age, 64.3 [7.2] years) experienced 1605 total MACE (1302 first and 303 recurrent events; median follow-up, 3.8 years [range, 0-5.2 years]). Patients who experienced any MACE were older (1 MACE: mean [SD] age, 65.6 [8.0] years; >1 MACE: 65.7 [7.9] years) and had diabetes for longer duration (1 MACE: mean [SD] duration, 13.4 [8.3] years; >1 MACE: 14.4 [8.7] years) compared with patients without MACE (mean [SD] age, 64.1 [7.1] years; mean [SD] duration, 12.7 [7.9] years). Fewer first and recurrent MACE occurred in the liraglutide group (n = 4668; 608 first and 127 recurrent events) than in the placebo group (n = 4672; 694 first and 176 recurrent events). Liraglutide was associated with a 15.7% relative risk reduction in total MACE (hazard ratio [HR], 0.84; 95% CI, 0.76-0.93) and a 13.4% reduction in total expanded MACE (HR, 0.87; 95% CI, 0.81-0.93) compared with placebo. For most individual cardiovascular end points, liraglutide was associated with lower risk vs placebo. Conclusions and Relevance These results suggest that liraglutide treatment is associated with reduced total MACE compared with placebo among patients with type 2 diabetes and high risk of cardiovascular events. This analysis supports the findings of an absolute benefit of liraglutide treatment with respect to the overall burden of cardiovascular events in this high-risk patient population. Trial Registration ClinicalTrials.gov identifier: NCT01179048.",2019,"Liraglutide was associated with a 15.7% relative risk reduction in total MACE (hazard ratio [HR], 0.84; 95% CI, 0.76-0.93) and a 13.4% reduction in total expanded MACE (HR, 0.87; 95% CI, 0.81-0.93) compared with placebo.","['patients with type 2 diabetes and high risk of cardiovascular events', 'The 9340 LEADER trial participants (6003 [64.3%] male; mean [SD] age, 64.3 [7.2] years) experienced 1605 total MACE (1302 first and 303 recurrent events; median follow-up, 3.8 years [range, 0-5.2 years', 'patients without MACE (mean [SD] age, 64.1 [7.1] years; mean [SD] duration, 12.7 [7.9] years', 'patients with type 2 diabetes who had established or were at high risk for cardiovascular disease at 410 sites in 32 countries from August 2010, to December 2015', 'Diabetes', 'Patients With Type', 'Patients who experienced any MACE were older (1 MACE: mean [SD] age, 65.6 [8.0] years; >1 MACE: 65.7 [7.9] years) and had diabetes for longer duration (1 MACE: mean [SD] duration, 13.4 [8.3] years', '2 Diabetes and High Risk of Cardiovascular Events']","['placebo', 'liraglutide', 'Liraglutide']","['total expanded MACE', 'MACE (cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke), expanded MACE (primary MACE plus coronary revascularization and hospitalization for heart failure or unstable angina pectoris), and the individual end points', 'Occurence of First and Recurrent Major Adverse Cardiovascular Events']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0332167', 'cui_str': 'High risk of (contextual qualifier) (qualifier value)'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517857', 'cui_str': '7.2 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0349381', 'cui_str': 'Mace (substance)'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C4517790', 'cui_str': '5.2 (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C4517546', 'cui_str': '12.7 (qualifier value)'}, {'cui': 'C0443211', 'cui_str': 'Established (qualifier value)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C4280965', 'cui_str': '>1'}, {'cui': 'C0439591', 'cui_str': 'Long duration (qualifier value)'}, {'cui': 'C4517558', 'cui_str': 'Thirteen point four'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1456408', 'cui_str': 'liraglutide'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0205229', 'cui_str': 'Expanding (qualifier value)'}, {'cui': 'C0349381', 'cui_str': 'Mace (substance)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0877341', 'cui_str': 'Coronary revascularisation'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0002965', 'cui_str': 'Angina at Rest'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}]",,0.134549,"Liraglutide was associated with a 15.7% relative risk reduction in total MACE (hazard ratio [HR], 0.84; 95% CI, 0.76-0.93) and a 13.4% reduction in total expanded MACE (HR, 0.87; 95% CI, 0.81-0.93) compared with placebo.","[{'ForeName': 'Subodh', 'Initials': 'S', 'LastName': 'Verma', 'Affiliation': ""Division of Cardiac Surgery, Li Ka Shing Knowledge Institute of St Michael's Hospital, University of Toronto, Toronto, Ontario, Canada.""}, {'ForeName': 'Stephen C', 'Initials': 'SC', 'LastName': 'Bain', 'Affiliation': 'Diabetes Research Unit Cymru, Swansea University Medical School, Swansea, United Kingdom.'}, {'ForeName': 'John B', 'Initials': 'JB', 'LastName': 'Buse', 'Affiliation': 'Department of Medicine, University of North Carolina School of Medicine at Chapel Hill, Chapel Hill.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Idorn', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Søren', 'Initials': 'S', 'LastName': 'Rasmussen', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'David D', 'Initials': 'DD', 'LastName': 'Ørsted', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Nauck', 'Affiliation': 'Diabetes Center Bochum-Hattingen, St Josef Hospital (Ruhr-Universität Bochum), Bochum, Germany.'}]",JAMA cardiology,['10.1001/jamacardio.2019.3080'] 1201,31408765,Unanticipated jump-landing after anterior cruciate ligament reconstruction: Does unanticipated jump-landing testing deliver additional return to sport information to traditional jump performance tests?,"BACKGROUND We aimed to delineate if unanticipated jump-landing assessments delivers complementary information to those of commonly used hop and jump tests after anterior cruciate ligament reconstruction. METHODS Eleven participants (5 males) performed a series of unanticipated jump-landings and traditional hop and jump performance tests (single leg hops for distance, triple crossover hops for distance and drop jumps). The number of mistrials, time to stabilization and peak ground reaction force (pGRF) at landing and jump/hop distance were measured. Pearson correlations to find potential associations between the unanticipated jump-landing-values and the traditional jump/hop performance tests were calculated twice: once for the affected and once for the unaffected legs. t-Tests for dependent samples were used to detect differences between affected and unaffected leg within each test condition. FINDINGS The pGRF at unanticipated landing significantly correlated to the pGRF at drop jump landing (r = 0.68) and the hopping distance after the triple crossover hops (r = 0.71, each p < .05). No other significant correlation occurred (p > .05). Hopping distance after single leg hops (mean: 110.2 cm vs. 95.5 cm) and triple crossover hops for distance (mean: 315.3 cm vs. 294.2 cm) showed significant differences between the unaffected and the reconstructed leg (p < .05). Other parameters showed no significant between-legs differences (p > .05). INTERPRETATION Both, the reconstructed and the contralateral leg seems to be affected. Unanticipated jump landing tasks deliver information beyond those of commonly used jump and hop tests, the thereby assessed abilities may thus be a complementary aspect of dynamic knee function than those assessed with classic tests.",2019,"The number of mistrials, time to stabilization and peak ground reaction force (pGRF) at landing and jump/hop distance were measured.","['anterior cruciate ligament reconstruction', 'after anterior cruciate ligament reconstruction', 'Eleven participants (5 males']","['Unanticipated jump-landing', 'unanticipated jump-landings and traditional hop and jump performance tests (single leg hops for distance, triple crossover hops for distance and drop jumps']","['number of mistrials, time to stabilization and peak ground reaction force (pGRF) at landing and jump/hop distance', 'hopping distance']","[{'cui': 'C3178820', 'cui_str': 'Anterior Cruciate Ligament Reconstruction'}, {'cui': 'C0086582', 'cui_str': 'Males'}]","[{'cui': 'C0560453', 'cui_str': 'Does jump (finding)'}, {'cui': 'C0557668', 'cui_str': 'Landing (environment)'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C4018995', 'cui_str': 'Hop'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C0205174', 'cui_str': 'Triple (qualifier value)'}, {'cui': 'C4318619', 'cui_str': 'Drop (unit of presentation)'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1293130', 'cui_str': 'Stabilization'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0443286', 'cui_str': 'Reaction (qualifier value)'}, {'cui': 'C0443221', 'cui_str': 'Forced (qualifier value)'}, {'cui': 'C0557668', 'cui_str': 'Landing (environment)'}, {'cui': 'C0560453', 'cui_str': 'Does jump (finding)'}, {'cui': 'C4018995', 'cui_str': 'Hop'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}]",11.0,0.0284076,"The number of mistrials, time to stabilization and peak ground reaction force (pGRF) at landing and jump/hop distance were measured.","[{'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Niemeyer', 'Affiliation': 'Department of Sports Medicine, Goethe University Frankfurt am Main, Germany. Electronic address: philipp.niemeyer@klinik-lippoldsberg.de.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Niederer', 'Affiliation': 'Department of Sports Medicine, Goethe University Frankfurt am Main, Germany; Preventive and Sports Medicine, Institute of Occupational, Social and Environmental Medicine, Hospital of the Goethe-University Frankfurt am Main, Germany.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Giesche', 'Affiliation': 'Preventive and Sports Medicine, Institute of Occupational, Social and Environmental Medicine, Hospital of the Goethe-University Frankfurt am Main, Germany.'}, {'ForeName': 'Maren', 'Initials': 'M', 'LastName': 'Janko', 'Affiliation': 'Department of Trauma- Hand and Reconstructive Surgery, Hospital of the Goethe-University Frankfurt am Main, Germany.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Frank', 'Affiliation': 'Department of Trauma- Hand and Reconstructive Surgery, Hospital of the Goethe-University Frankfurt am Main, Germany.'}, {'ForeName': 'Lutz', 'Initials': 'L', 'LastName': 'Vogt', 'Affiliation': 'Department of Sports Medicine, Goethe University Frankfurt am Main, Germany.'}, {'ForeName': 'Winfried', 'Initials': 'W', 'LastName': 'Banzer', 'Affiliation': 'Preventive and Sports Medicine, Institute of Occupational, Social and Environmental Medicine, Hospital of the Goethe-University Frankfurt am Main, Germany.'}]","Clinical biomechanics (Bristol, Avon)",['10.1016/j.clinbiomech.2019.08.003'] 1202,30664989,A Randomized Non-Comparative Phase II Study of Anti-Programmed Cell Death-Ligand 1 Atezolizumab or Chemotherapy as Second-Line Therapy in Patients With Small Cell Lung Cancer: Results From the IFCT-1603 Trial.,"INTRODUCTION This randomized phase II trial aimed at evaluating the engineered programmed cell death ligand 1 (PD-L1) antibody atezolizumab in SCLC progressing after first-line platinum-etoposide chemotherapy. METHODS Patients were randomized 2:1 to atezolizumab (1200 mg intravenously every 3 weeks) until progression or unacceptable toxicity, or conventional chemotherapy (up to 6 cycles of topotecan or re-induction of initial chemotherapy). Patients were not selected based on PD-L1 tissue expression. The primary endpoint was objective response rate at 6 weeks. A two-stage design with 2:1 randomization and O'Brien-Fleming stopping rules was used. The null hypothesis was rejected if more than 12 of 45 patients were responders. RESULTS Overall, 73 patients were randomized (atezolizumab n = 49; chemotherapy n = 24). At 6 weeks, 1 of 43 eligible atezolizumab patients achieved an objective response (2.3%, 95% confidence interval [CI]: 0.0-6.8), whereas 8 others had stable disease (20.9% disease control rate; 95% CI: 8.8-33.1). Among eligible chemotherapy patients (n = 20), 10% achieved an objective response (65% disease control rate). Median progression-free survival was 1.4 months (95% CI: 1.2-1.5) with atezolizumab and 4.3 months (95% CI: 1.5-5.9) with chemotherapy. Overall survival did not significantly differ between groups. Median overall survival was 9.5 months versus 8.7 months for the atezolizumab and the chemotherapy group, respectively (adjusted hazard ratio atezolizumab : 0.84, 95% CI: 0.45-1.58; p = 0.60). Two atezolizumab patients (4.2%) experienced grade 3 fatigue, and two others grade 1 dysthyroidism. Among 53 evaluable specimens, only 1 (2%) had positive immunohistochemical PD-L1 staining (SP142 clone). CONCLUSIONS Atezolizumab monotherapy in relapsed SCLC failed to show significant efficacy. No unexpected safety concerns were observed.",2019,"atezolizumab : 0.84, 95% CI: 0.45-1.58; p = 0.60).","['Patients With Small Cell Lung Cancer', '73 patients were randomized (atezolizumab n\xa0= 49; chemotherapy n\xa0= 24', 'Patients', 'SCLC progressing after first-line platinum-etoposide chemotherapy']","['Anti-Programmed Cell Death-Ligand 1 Atezolizumab or Chemotherapy', 'atezolizumab (1200 mg intravenously every 3 weeks) until progression or unacceptable toxicity, or conventional chemotherapy (up to 6 cycles of topotecan or re-induction of initial chemotherapy', 'atezolizumab', 'engineered programmed cell death ligand 1 (PD-L1) antibody atezolizumab', 'Atezolizumab monotherapy']","['grade 3 fatigue', 'positive immunohistochemical PD-L1 staining (SP142 clone', 'Overall survival', 'stable disease', 'Median overall survival', 'objective response rate', 'Median progression-free survival', 'objective response']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0149925', 'cui_str': 'Oat Cell Lung Cancer'}, {'cui': 'C4055433', 'cui_str': 'atezolizumab'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C0015133', 'cui_str': 'Etoposide'}]","[{'cui': 'C0007587', 'cui_str': 'Cell Death'}, {'cui': 'C0023688', 'cui_str': 'Ligands'}, {'cui': 'C4055433', 'cui_str': 'atezolizumab'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C4517548', 'cui_str': 'One thousand two hundred'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0146224', 'cui_str': 'Topotecan'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0878517', 'cui_str': 'Engineer'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}]","[{'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0487602', 'cui_str': 'Staining'}, {'cui': 'C0009013', 'cui_str': 'Clones'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",73.0,0.264905,"atezolizumab : 0.84, 95% CI: 0.45-1.58; p = 0.60).","[{'ForeName': 'Jean-Louis', 'Initials': 'JL', 'LastName': 'Pujol', 'Affiliation': 'Department of Thoracic Oncology, Montpellier Regional University Hospital, Montpellier, France. Electronic address: jl-pujol@chu-montpellier.fr.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Greillier', 'Affiliation': 'Department of Multidisciplinary Oncology and Therapeutic Innovations, Assistance Publique - Hôpitaux de Marseille, Aix Marseille University, Marseille, France.'}, {'ForeName': 'Clarisse', 'Initials': 'C', 'LastName': 'Audigier-Valette', 'Affiliation': 'Department of Thoracic Oncology, CHITS CH Sainte Musse, Toulon, France.'}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Moro-Sibilot', 'Affiliation': 'Thoracic Oncology Unit, CHU Grenoble Alpes, Grenoble, France.'}, {'ForeName': 'Lionel', 'Initials': 'L', 'LastName': 'Uwer', 'Affiliation': 'Institut de Cancerologie de Lorraine Alexis Vautrin. 6 Avenue de Bourgogne, Vandoeuvre-les-Nancy, France.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Hureaux', 'Affiliation': 'Pôle Hippocrate, Angers University Hospital, Angers, France.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Guisier', 'Affiliation': 'Service de Pneumologie, Oncologie Thoracique et soins Intensifs Respiratoires, CHU de Rouen, Rouen, France.'}, {'ForeName': 'Delphine', 'Initials': 'D', 'LastName': 'Carmier', 'Affiliation': 'Service de Pneumologie CHRU Hôpitaux de Tours, Hôpital Bretonneau, Tours, France.'}, {'ForeName': 'Jeannick', 'Initials': 'J', 'LastName': 'Madelaine', 'Affiliation': 'Service de Pneumologie, CHU Caen Normandie, Caen, France.'}, {'ForeName': 'Josiane', 'Initials': 'J', 'LastName': 'Otto', 'Affiliation': 'Pôle Médecine, Centre Antoine Lacassagne, Nice, France.'}, {'ForeName': 'Valérie', 'Initials': 'V', 'LastName': 'Gounant', 'Affiliation': 'Department of Thoracic Oncology, Bichat Claude Bernard Hospital, Paris, France.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Merle', 'Affiliation': 'Service de Pneumologie, Chu Gabriel-Montpied, Clermont-Ferrand, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Mourlanette', 'Affiliation': 'Clinique des Cèdres, Château Alliez, Cornebarrieu, France.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Molinier', 'Affiliation': 'Service de Pneumologie, Centre Hospitalier du Mans, Le Mans, France.'}, {'ForeName': 'Aldo', 'Initials': 'A', 'LastName': 'Renault', 'Affiliation': 'Service de Pneumologie, Centre Hospitalier de Pau, Pau, France.'}, {'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'Rabeau', 'Affiliation': 'Toulouse University Hospital, Université Paul Sabatier, Toulouse, France.'}, {'ForeName': 'Martine', 'Initials': 'M', 'LastName': 'Antoine', 'Affiliation': ""Service d'Anatomo-pathologie, Hôpitaux Universitaires Est Parisien Site Tenon, Paris, France.""}, {'ForeName': 'Marc G', 'Initials': 'MG', 'LastName': 'Denis', 'Affiliation': 'Department of Biochemistry, Nantes University Hospital, Nantes, France.'}, {'ForeName': 'Sebastien', 'Initials': 'S', 'LastName': 'Bommart', 'Affiliation': 'Department of radiology, Montpellier Regional University Hospital, Montpellier, France.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Langlais', 'Affiliation': 'Intergroupe Francophone de Cancérologie Thoracique, Paris, France.'}, {'ForeName': 'Franck', 'Initials': 'F', 'LastName': 'Morin', 'Affiliation': 'Intergroupe Francophone de Cancérologie Thoracique, Paris, France.'}, {'ForeName': 'Pierre-Jean', 'Initials': 'PJ', 'LastName': 'Souquet', 'Affiliation': 'Service de Pneumologie Aiguë Spécialisée et Cancérologie Thoracique, Centre Hospitalier Lyon, Lyon, France.'}]",Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer,['10.1016/j.jtho.2019.01.008'] 1203,31679865,"A phase 1, randomized, observer blind, antigen and adjuvant dosage finding clinical trial to evaluate the safety and immunogenicity of an adjuvanted, trivalent subunit influenza vaccine in adults ≥ 65 years of age.","OBJECTIVE To assess the safety and immunogenicity of the MF59®-adjuvanted trivalent influenza vaccine (aTIV; Fluad®) compared with modified aTIV formulations. METHODS A total of 196 subjects ≥ 65 years were randomized to receive7different formulations of vaccine containing a range of adjuvant and antigen dosesby single injection, or divided into two injections at a single time point. The primary study objective was to compare the serologic response of different formulations of aTIV containing increased amounts of adjuvant and antigen21 days after vaccination. Subjects were followed for immunogenicity and safety for one year. RESULTS The highest immune response, as measured by hemagglutination inhibition (HI) assay, 3 weeks after vaccination was observed in subjects in Group 6 with GMT 382.2 (95% confidence interval [CI] 237.5 to 615.0), 552.3 (364.8 to 836.1), and 54.1 (36.9 to 79.4) against A/H1N1, A/H3N2, and B respectively. Rates of seroconversion were also generally highest in this treatment group: 75% (95% CI 55.1 to 89.3), 75% (55.1 to 89.3), and 42.9% (24.5 to 62.8), respectively, against A/H1N1, A/H3N2, and B strains. The highest incidence of solicited adverse events (AEs) was reported by subjects who received both the highest dosage of antigen in combination with the highest dosage of adjuvant at the same site: 67.9% and 57.1% in Groups 4 and 6, respectively. The majority of solicited AEs were mild to moderate in severity. The number of unsolicited AEs was similar across the different dosages. CONCLUSION In this phase I trial of adults ≥ 65 years of age who received increased adjuvant and antigen dosages relative to the licensed aTIV, increased dosage of MF59 resulted in increased immunogenicity against all 3 components of seasonal influenza vaccine. The increase in immunogenicity was accompanied by an increase in the incidence of local reactogenicity.",2020,"RESULTS The highest immune response, as measured by hemagglutination inhibition (HI) assay, 3 weeks after vaccination was observed in subjects in Group 6 with GMT 382.2","['adults', '196 subjects\u202f≥\u202f65\u202fyears', 'adults\u202f≥\u202f65 years of age']","['MF59®-adjuvanted trivalent influenza vaccine (aTIV; Fluad®', 'receive7different formulations of vaccine containing a range of adjuvant and antigen dosesby single injection', 'adjuvanted, trivalent subunit influenza vaccine']","['Rates of seroconversion', 'hemagglutination inhibition (HI) assay', 'number of unsolicited AEs', 'serologic response', 'local reactogenicity', 'safety and immunogenicity', 'immunogenicity', 'immunogenicity and safety']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4517625', 'cui_str': '196'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0289787', 'cui_str': 'MF59'}, {'cui': 'C0770694'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0003320', 'cui_str': 'Antigens'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0021403', 'cui_str': 'Influenza Vaccines'}]","[{'cui': 'C4042908', 'cui_str': 'Seroconversion'}, {'cui': 'C0018904', 'cui_str': 'Hemagglutination Inhibition Tests'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0205473', 'cui_str': 'Serologic (qualifier value)'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",196.0,0.122775,"RESULTS The highest immune response, as measured by hemagglutination inhibition (HI) assay, 3 weeks after vaccination was observed in subjects in Group 6 with GMT 382.2","[{'ForeName': 'Gillis', 'Initials': 'G', 'LastName': 'Otten', 'Affiliation': 'Seqirus Inc., 50 Hampshire Street, Cambridge, MA 02139, United States. Electronic address: Gillis.Otten@Seqirus.com.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Matassa', 'Affiliation': 'Seqirus Australia, 63 Poplar Road, Parkville, Victoria 3052, Australia. Electronic address: Vince.Matassa@Seqirus.com.'}, {'ForeName': 'Max', 'Initials': 'M', 'LastName': 'Ciarlet', 'Affiliation': 'Novartis Vaccines and Diagnostics, 45 Sidney Street, Cambridge, MA 02139, United States.'}, {'ForeName': 'Brett', 'Initials': 'B', 'LastName': 'Leav', 'Affiliation': 'Seqirus Inc., 50 Hampshire Street, Cambridge, MA 02139, United States. Electronic address: Brett.Leav@Seqirus.com.'}]",Vaccine,['10.1016/j.vaccine.2019.10.058'] 1204,31657454,Comparison of real costs in the French healthcare system in newly diagnosed patients with pemphigus for first-line treatment with rituximab vs. standard corticosteroid regimen: data from a national multicentre trial.,"BACKGROUND Rituximab has been demonstrated to be highly effective as a first-line treatment for moderate-to-severe pemphigus; however, its high cost can be considered a limitation of this treatment. OBJECTIVES To compare direct costs of two regimens, rituximab + short-term prednisone vs. prednisone alone, tested in the Ritux3 trial. METHODS Patients were randomly assigned to receive 2 g of rituximab and two 500-mg maintenance infusions at month 12 and month 18 along with low doses of prednisone for 3-6 months, or high doses of prednisone alone tapered over 12-18 months. We estimated the direct costs related to (i) protocol (treatments, consultations, hospitalizations); (ii) unfavourable disease course (relapse); and (iii) adverse events in both treatment groups during a 3-year follow-up. RESULTS Annual individual cost discrepancies related to drugs decreased from +€3597 to -€1589 from the first to the third year, which corresponded to an initially higher cost in the rituximab group, counterbalanced during follow-up by costs related to treatment of patients with persistent disease activity/relapses in the standard corticosteroid (CS) group. Individual costs relating to treatment of adverse events were higher in the standard CS group (€4352) than in the rituximab group (€2468). Overall, mean individual total cost over the 3 years of follow-up was €13 997 in the standard CS arm vs. €14 818 in the rituximab arm, corresponding to a difference of €821 more per patient (+6%). CONCLUSIONS First-line treatment of pemphigus with rituximab results in a slightly greater cost compared with a standard CS regimen. What's already known about this topic Rituximab is the most effective treatment for moderate-to-severe pemphigus. Rituximab cost might be considered as a limitation of this treatment. What does this study add? After 3 years of follow-up, mean individual total cost for a patient with first-line treatment with rituximab was €14 818 vs. €13 997 with standard corticosteroids (CS), resulting in a slightly higher cost of €821 (+6%). The initially greater cost of rituximab was counterbalanced by costs related to management of flares/relapses in patients treated with a standard CS regimen.",2020,Individual costs relating to treatment of adverse events were higher in the standard CS group (€4352) than in the rituximab group (€2468).,"['Patients', 'newly diagnosed pemphigus patients']","['rituximab + short-term prednisone vs. prednisone', 'prednisone', 'rituximab', 'rituximab versus standard corticosteroid regimen']","['mean individual total cost', 'direct costs related to (i) protocol (treatments, consultations, hospitalizations); (ii) unfavourable disease course (relapse); and (iii) adverse events', 'adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0030807', 'cui_str': 'Pemphigus'}]","[{'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0750729', 'cui_str': 'Courses (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",821.0,0.0367292,Individual costs relating to treatment of adverse events were higher in the standard CS group (€4352) than in the rituximab group (€2468).,"[{'ForeName': 'V', 'Initials': 'V', 'LastName': 'Hébert', 'Affiliation': 'Department of Dermatology, Rouen University Hospital, and INSERM U 1234, Centre de Référence des Maladies Bulleuses Auto-immunes, Normandie University, Rouen, France.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Vermeulin', 'Affiliation': 'Department of Biostatistics and Clinical Research, INSERM U 1219, Rouen University Hospital, University of Rouen, Rouen, France.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Tanguy', 'Affiliation': 'Department of Biostatistics and Clinical Research, INSERM U 1219, Rouen University Hospital, University of Rouen, Rouen, France.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Tedbirt', 'Affiliation': 'Department of Dermatology, Rouen University Hospital, and INSERM U 1234, Centre de Référence des Maladies Bulleuses Auto-immunes, Normandie University, Rouen, France.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Mignard', 'Affiliation': 'Department of Dermatology, Rouen University Hospital, and INSERM U 1234, Centre de Référence des Maladies Bulleuses Auto-immunes, Normandie University, Rouen, France.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Bénichou', 'Affiliation': 'Department of Biostatistics and Clinical Research, INSERM U 1219, Rouen University Hospital, University of Rouen, Rouen, France.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Joly', 'Affiliation': 'Department of Dermatology, Rouen University Hospital, and INSERM U 1234, Centre de Référence des Maladies Bulleuses Auto-immunes, Normandie University, Rouen, France.'}]",The British journal of dermatology,['10.1111/bjd.18563'] 1205,30487565,Sleep and meal timing influence food intake and its hormonal regulation in healthy adults with overweight/obesity.,"BACKGROUND Studies associate sleeping and eating late in the day with poor dietary quality and higher obesity risk but differences in sleep duration confound this association. We aimed to determine whether sleep and meal timing, independent of sleep duration, influenced food intake in healthy adults. METHODS This was a controlled, 2 × 2 inpatient crossover study with normal (0000-0800 h) or late (0330-1130 h) sleep and normal (1, 5, 11, and 12.5 h after awakening) or late (4.5, 8.5, 14.5, and 16 h after awakening) meals. Food intake was controlled while blood samples were obtained for determination of appetite-regulating hormones on days 3-4. Self-selected food intake was assessed on day 5. Data were analyzed using linear mixed model analysis with sleep, meal, and sleep x meal interaction as dependent variables. RESULTS Five participants completed all phases (mean age 25.1 ± [SD] 3.9 y, body mass index 29.2 ± 2.7 kg/m 2 ). There was a significant sleep x meal interaction on energy intake (P = 0.035) and trends on fat and sodium intakes (P < 0.10). Overnight ghrelin concentrations were higher under normal sleep and meal conditions relative to late (P < 0.005) but lower when both were combined (P < 0.001). Overnight leptin concentrations were higher under normal meal conditions (P = 0.012). There was a significant sleep x meal interaction on ghrelin (P = 0.032) and glucagon-like peptide 1 (P = 0.041) concentrations, but not leptin (P = 0.83), in response to a test meal. CONCLUSIONS Our results suggest that alignment of sleep and meals may influence food choice and energy balance. Additional research is necessary to expand and confirm our findings.",2019,"There was a significant sleep x meal interaction on ghrelin (P = 0.032) and glucagon-like peptide 1 (P = 0.041) concentrations, but not leptin (P = 0.83), in response to a test meal. ","['healthy adults with overweight/obesity', 'Five participants completed all phases (mean age 25.1\u2009±\u2009[SD] 3.9\u2009y, body mass index 29.2\u2009±\u20092.7\u2009kg/m 2 ', '2\u2009×\u20092 inpatient crossover study with normal (0000-0800\u2009h) or late (0330-1130\u2009h) sleep and normal (1, 5, 11, and 12.5\u2009h after awakening) or late (4.5, 8.5, 14.5, and 16\u2009h after awakening) meals', 'healthy adults']",['Sleep and meal timing influence food intake'],"['Overnight leptin concentrations', 'sleep x meal interaction on ghrelin', 'fat and sodium intakes', 'sleep x meal interaction on energy intake', 'Overnight ghrelin concentrations']","[{'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517698', 'cui_str': '3.9 (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517635', 'cui_str': '2.7'}, {'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C0150097', 'cui_str': 'Crossover Trials'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C4517544', 'cui_str': '12.5 (qualifier value)'}, {'cui': 'C3844009', 'cui_str': 'Four point five'}, {'cui': 'C4517877', 'cui_str': '8.5'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}]","[{'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C0449243', 'cui_str': 'Timing (attribute)'}, {'cui': 'C0013470', 'cui_str': 'Food Intake'}]","[{'cui': 'C0439583', 'cui_str': 'Overnight (qualifier value)'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}, {'cui': 'C0911014', 'cui_str': 'Ghrelin (substance)'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C3541959', 'cui_str': 'Sodium supplement (substance)'}, {'cui': 'C0006777', 'cui_str': 'Caloric Intake'}]",5.0,0.0477511,"There was a significant sleep x meal interaction on ghrelin (P = 0.032) and glucagon-like peptide 1 (P = 0.041) concentrations, but not leptin (P = 0.83), in response to a test meal. ","[{'ForeName': 'Marie-Pierre', 'Initials': 'MP', 'LastName': 'St-Onge', 'Affiliation': 'New York Obesity Nutrition Research Center, Department of Medicine, Columbia University Medical Center, New York, NY, USA. ms2554@cumc.columbia.edu.'}, {'ForeName': 'Theresa', 'Initials': 'T', 'LastName': 'Pizinger', 'Affiliation': 'New York Obesity Nutrition Research Center, Department of Medicine, Columbia University Medical Center, New York, NY, USA.'}, {'ForeName': 'Kyle', 'Initials': 'K', 'LastName': 'Kovtun', 'Affiliation': 'New York Obesity Nutrition Research Center, Department of Medicine, Columbia University Medical Center, New York, NY, USA.'}, {'ForeName': 'Arindam', 'Initials': 'A', 'LastName': 'RoyChoudhury', 'Affiliation': 'Division of Biostatistics and Epidemiology, Department of Healthcare Policy and Research, Weill Cornell Medicine, Cornell University, New York, NY, USA.'}]",European journal of clinical nutrition,['10.1038/s41430-018-0312-x'] 1206,32005992,Delayed iron improves iron status without altering malaria risk in severe malarial anemia.,"BACKGROUND WHO guidelines recommend concurrent iron and antimalarial treatment in children with malaria and iron deficiency, but iron may not be well absorbed or utilized during a malaria episode. OBJECTIVES We aimed to determine whether starting iron 28 d after antimalarial treatment in children with severe malaria and iron deficiency would improve iron status and lower malaria risk. METHODS We conducted a randomized clinical trial on the effect of immediate compared with delayed iron treatment in Ugandan children 18 mo-5 y of age with 2 forms of severe malaria: cerebral malaria (CM; n = 79) or severe malarial anemia (SMA; n = 77). Asymptomatic community children (CC; n = 83) were enrolled as a comparison group. Children with iron deficiency, defined as zinc protoporphyrin (ZPP) ≥ 80 µmol/mol heme, were randomly assigned to receive a 3-mo course of daily oral ferrous sulfate (2 mg · kg-1 · d-1) either concurrently with antimalarial treatment (immediate arm) or 28 d after receiving antimalarial treatment (delayed arm). Children were followed for 12 mo. RESULTS All children with CM or SMA, and 35 (42.2%) CC, were iron-deficient and were randomly assigned to immediate or delayed iron treatment. Immediate compared with delayed iron had no effect in any of the 3 study groups on the primary study outcomes (hemoglobin concentration and prevalence of ZPP ≥ 80 µmol/mol heme at 6 mo, malaria incidence over 12 mo). However, after 12 mo, children with SMA in the delayed compared with the immediate arm had a lower prevalence of iron deficiency defined by ZPP (29.4% compared with 65.6%, P = 0.006), a lower mean concentration of soluble transferrin receptor (6.1 compared with 7.8 mg/L, P = 0.03), and showed a trend toward fewer episodes of severe malaria (incidence rate ratio: 0.39; 95% CI: 0.14, 1.12). CONCLUSIONS In children with SMA, delayed iron treatment did not increase hemoglobin concentration, but did improve long-term iron status over 12 mo without affecting malaria incidence.This trial was registered at clinicaltrials.gov as NCT01093989.",2020,"Immediate compared with delayed iron had no effect in any of the 3 study groups on the primary study outcomes (hemoglobin concentration and prevalence of ZPP ≥ 80 µmol/mol heme at 6 mo, malaria incidence over 12 mo).","['children with malaria and iron deficiency', 'Asymptomatic community children (CC; n\xa0=\xa083', 'All children with CM or SMA, and 35 (42.2%) CC, were iron-deficient', 'children with severe malaria and iron deficiency would improve iron status and lower malaria risk', 'Children with iron deficiency, defined as zinc protoporphyrin (ZPP) ≥ 80 µmol/mol heme', 'severe malarial anemia', 'Ugandan children 18 mo-5 y of age with 2 forms of severe malaria: cerebral malaria (CM; n\xa0=\xa079) or severe malarial anemia (SMA; n\xa0=\xa077']","['daily oral ferrous sulfate (2 mg · kg-1 · d-1) either concurrently with antimalarial treatment (immediate arm) or 28 d after receiving antimalarial treatment (delayed arm', 'delayed iron treatment']","['mean concentration of soluble transferrin receptor', 'hemoglobin concentration', 'episodes of severe malaria', 'prevalence of iron deficiency defined by ZPP', 'hemoglobin concentration and prevalence of ZPP\xa0≥\xa080 µmol/mol heme at 6 mo, malaria incidence']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0024530', 'cui_str': 'Plasmodium Infections'}, {'cui': 'C0240066', 'cui_str': 'Iron deficiency (disorder)'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic (finding)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0337439', 'cui_str': 'Iron measurement (procedure)'}, {'cui': 'C0011155', 'cui_str': 'Deficient (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0078791', 'cui_str': 'zinc protoporphyrin'}, {'cui': 'C0439189', 'cui_str': 'mole - unit'}, {'cui': 'C0018966', 'cui_str': 'Protoheme'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0241520', 'cui_str': 'Ugandans (ethnic group)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0024534', 'cui_str': 'Malaria, Cerebral'}]","[{'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0060282', 'cui_str': 'ferrous sulfate'}, {'cui': 'C0003374', 'cui_str': 'Antimalarial Agents'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0337439', 'cui_str': 'Iron measurement (procedure)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1116139', 'cui_str': 'Transferrin receptor, soluble (substance)'}, {'cui': 'C1318517', 'cui_str': 'Hemoglobin concentration, dipstick - finding'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0024530', 'cui_str': 'Plasmodium Infections'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C0240066', 'cui_str': 'Iron deficiency (disorder)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0439189', 'cui_str': 'mole - unit'}, {'cui': 'C0018966', 'cui_str': 'Protoheme'}, {'cui': 'C0220856', 'cui_str': 'incidence'}]",83.0,0.421433,"Immediate compared with delayed iron had no effect in any of the 3 study groups on the primary study outcomes (hemoglobin concentration and prevalence of ZPP ≥ 80 µmol/mol heme at 6 mo, malaria incidence over 12 mo).","[{'ForeName': 'Sarah E', 'Initials': 'SE', 'LastName': 'Cusick', 'Affiliation': 'Department of Pediatrics, University of Minnesota School of Medicine, Minneapolis, MN, USA.'}, {'ForeName': 'Robert O', 'Initials': 'RO', 'LastName': 'Opoka', 'Affiliation': 'Department of Paediatrics and Child Health, Makerere University College of Health Sciences, Kampala, Uganda.'}, {'ForeName': 'Andrew S', 'Initials': 'AS', 'LastName': 'Ssemata', 'Affiliation': 'Department of Paediatrics and Child Health, Makerere University College of Health Sciences, Kampala, Uganda.'}, {'ForeName': 'Michael K', 'Initials': 'MK', 'LastName': 'Georgieff', 'Affiliation': 'Department of Pediatrics, University of Minnesota School of Medicine, Minneapolis, MN, USA.'}, {'ForeName': 'Chandy C', 'Initials': 'CC', 'LastName': 'John', 'Affiliation': 'Department of Pediatrics, University of Minnesota School of Medicine, Minneapolis, MN, USA.'}]",The American journal of clinical nutrition,['10.1093/ajcn/nqaa004'] 1207,29471905,Delay in seeking care for tuberculosis symptoms among adults newly diagnosed with HIV in rural Malawi.,"SETTING Ten primary health clinics in rural Thyolo District, Malawi. OBJECTIVE Tuberculosis (TB) is a common initial presentation of human immunodeficiency virus (HIV) infection. We investigated the time from TB symptom onset to HIV diagnosis to describe TB health-seeking behaviour in adults newly diagnosed with HIV. DESIGN We asked adults (18 years) about the presence and duration of TB symptoms at the time of receiving a new HIV diagnosis. Associations with delayed health seeking (defined as >30 and >90 days from the onset of TB symptoms) were evaluated using multivariable logistic regression. RESULTS TB symptoms were reported by 416 of 1265 participants (33%), of whom 36% (150/416) had been symptomatic for >30 days before HIV testing. Most participants (260/416, 63%) were below the poverty line (US$0.41 per household member per day). Patients who first sought care from informal providers had an increased odds of delay of >30 days (adjusted odds ratio [aOR] 1.6, 95%CI 0.9-2.8) or 90 days (aOR 2.0, 95%CI 1.1-3.8). CONCLUSIONS Delayed health seeking for TB-related symptoms was common. Poverty was ubiquitous, but had no clear relationship to diagnostic delay. HIV-positive individuals who first sought care from informal providers were more likely to experience diagnostic delays for TB symptoms.",2018,"Patients who first sought care from informal providers had an increased odds of delay of >30 days (adjusted odds ratio [aOR] 1.6, 95%CI 0.9-2.8) or 90 days (aOR 2.0,","['adults newly diagnosed with HIV', 'adults newly diagnosed with HIV in rural Malawi', 'human immunodeficiency virus (HIV) infection', 'HIV-positive individuals who first sought care from informal providers', 'Ten primary health clinics in rural Thyolo District, Malawi']",[],"['odds of delay of >30 days', 'TB symptoms']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0024548', 'cui_str': 'Republic of Malawi'}, {'cui': 'C0019693', 'cui_str': 'T-Lymphotropic Virus Type III Infections, Human'}, {'cui': 'C0019699', 'cui_str': 'HTLV-III Seroconversion'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}]",[],"[{'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",1265.0,0.29138,"Patients who first sought care from informal providers had an increased odds of delay of >30 days (adjusted odds ratio [aOR] 1.6, 95%CI 0.9-2.8) or 90 days (aOR 2.0,","[{'ForeName': 'L G', 'Initials': 'LG', 'LastName': 'Ngwira', 'Affiliation': 'HIV & TB Group, Malawi-Liverpool-Wellcome Trust Clinical Research Programme, Blantyre, Malawi, Liverpool School of Tropical Medicine, Liverpool, UK.'}, {'ForeName': 'D W', 'Initials': 'DW', 'LastName': 'Dowdy', 'Affiliation': 'Center for TB Research, Johns Hopkins School of Medicine, Baltimore, Maryland, Department of Epidemiology, Department of International Health, Johns Hopkins Bloomberg School of Public Health Baltimore, Maryland, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Khundi', 'Affiliation': 'HIV & TB Group, Malawi-Liverpool-Wellcome Trust Clinical Research Programme, Blantyre, Malawi.'}, {'ForeName': 'G L', 'Initials': 'GL', 'LastName': 'Barnes', 'Affiliation': 'Center for TB Research, Johns Hopkins School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Nkhoma', 'Affiliation': 'HIV & TB Group, Malawi-Liverpool-Wellcome Trust Clinical Research Programme, Blantyre, Malawi.'}, {'ForeName': 'A T', 'Initials': 'AT', 'LastName': 'Choko', 'Affiliation': 'HIV & TB Group, Malawi-Liverpool-Wellcome Trust Clinical Research Programme, Blantyre, Malawi.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Murowa', 'Affiliation': 'Ministry of Health, Lilongwe, Malawi.'}, {'ForeName': 'R E', 'Initials': 'RE', 'LastName': 'Chaisson', 'Affiliation': 'Center for TB Research, Johns Hopkins School of Medicine, Baltimore, Maryland, Department of Epidemiology, Department of International Health, Johns Hopkins Bloomberg School of Public Health Baltimore, Maryland, USA.'}, {'ForeName': 'E L', 'Initials': 'EL', 'LastName': 'Corbett', 'Affiliation': 'HIV & TB Group, Malawi-Liverpool-Wellcome Trust Clinical Research Programme, Blantyre, Malawi, TB Centre, London School of Hygiene & Tropical Medicine, London, UK.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Fielding', 'Affiliation': 'TB Centre, London School of Hygiene & Tropical Medicine, London, UK.'}]",The international journal of tuberculosis and lung disease : the official journal of the International Union against Tuberculosis and Lung Disease,['10.5588/ijtld.17.0539'] 1208,31747786,Patients With Atrial Fibrillation Taking Nonsteroidal Anti-Inflammatory Drugs and Oral Anticoagulants in the ARISTOTLE Trial.,"BACKGROUND The use of nonsteroidal anti-inflammatory drugs (NSAIDs) with oral anticoagulants has been associated with an increased risk of bleeding. We investigated the risk of bleeding and major cardiovascular outcomes in patients with atrial fibrillation taking NSAIDs and apixaban or warfarin. METHODS The ARISTOTLE trial (Apixaban for Reduction in Stroke and Other Thromboembolic Events in Atrial Fibrillation; n=18 201) compared apixaban with warfarin in patients with atrial fibrillation at an increased risk of stroke. Patients in ARISTOTLE without severe renal (creatine clearance ≤30 mL/min) or liver disease were included in this analysis (n=17 423). NSAID use at baseline, NSAID use during the trial (incident NSAID use), and never users were described. The primary outcome was major bleeding. Secondary outcomes included clinically relevant nonmajor bleeding, gastrointestinal bleeding, heart failure hospitalization, stroke or systemic embolism, and all-cause mortality. NSAID use during the trial, and the interaction between randomized treatment, was analyzed using time-dependent Cox proportional hazards models. RESULTS Those with baseline NSAID use (n=832 [4.8%]), incident NSAID use (n=2185 [13.2%]), and never users were similar in median age (age [25th, 75th]; 70 [64, 77] versus 70 [63, 75] versus 70 [62, 76]). Those with NSAID use at baseline and incident NSAID use were more likely to have a history of bleeding than never users (24.5% versus 21.0% versus 15.6%, respectively). During a median follow-up (25th, 75th) of 1.8 (1.4, 2.3) years and when excluding those taking NSAID at baseline, we found that incident NSAID use was associated with an increased risk of major bleeding (hazard ratio [HR], 1.61 [95% CI, 1.11-2.33]) and clinically relevant nonmajor bleeding (HR, 1.70 [95% CI, 1.16-2.48]), but not gastrointestinal bleeding. No significant interaction was observed between NSAID use and randomized treatment for any outcome. CONCLUSIONS A substantial number of patients in the ARISTOTLE trial took NSAIDs. Incident NSAID use was associated with major and clinically relevant nonmajor bleeding, but not with gastrointestinal bleeding. The safety and efficacy of apixaban versus warfarin appeared not significantly to be altered by NSAID use. This study warrants more investigation of the effect of NSAIDs on the outcomes of patients treated with apixaban. CLINICAL TRIAL REGISTRATION URL: https://www.clinicaltrials.gov. Unique identifier: NCT00412984.",2020,No significant interaction was observed between NSAID use and randomized treatment for any outcome. ,"['patients with atrial fibrillation (AF) taking NSAIDs and apixaban or warfarin', 'Patients with Atrial Fibrillation Taking Nonsteroidal Anti-Inflammatory Drugs and Oral Anticoagulants', 'Patients in ARISTOTLE without severe renal (creatine clearance ≤30 mL/min) or liver disease were included in this analysis (n=17,423', 'patients with AF at increased risk of stroke', 'patients treated with apixaban']","['nonsteroidal anti-inflammatory drugs (NSAIDs) with oral anticoagulants', 'apixaban versus warfarin', 'NSAIDs', 'apixaban with warfarin']","['gastrointestinal bleeding', 'risk of major bleeding (hazard ratio [HR', 'history of bleeding', 'clinically relevant non-major (CRNM) bleeding, gastrointestinal bleeding, heart failure hospitalization, stroke or systemic embolism, and all-cause mortality', 'major bleeding', 'risk of bleeding', 'risk of bleeding and major cardiovascular outcomes', 'clinically relevant non-major bleeding', 'safety and efficacy']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0003211', 'cui_str': 'Anti Inflammatory Agents, Nonsteroidal'}, {'cui': 'C1831808', 'cui_str': 'apixaban'}, {'cui': 'C0043031', 'cui_str': 'Warfarin'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0003280', 'cui_str': 'Anticoagulation Agents'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0010286', 'cui_str': 'Creatine'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}, {'cui': 'C0439445', 'cui_str': 'mL/min'}, {'cui': 'C0023895', 'cui_str': 'Disorder of liver (disorder)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}]","[{'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0003280', 'cui_str': 'Anticoagulation Agents'}, {'cui': 'C1831808', 'cui_str': 'apixaban'}, {'cui': 'C0043031', 'cui_str': 'Warfarin'}]","[{'cui': 'C0017181', 'cui_str': 'Gastrointestinal Hemorrhage'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0013922', 'cui_str': 'Embolism'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.18801,No significant interaction was observed between NSAID use and randomized treatment for any outcome. ,"[{'ForeName': 'Frederik', 'Initials': 'F', 'LastName': 'Dalgaard', 'Affiliation': 'Department of Cardiology, Herlev and Gentofte Hospital, Hellerup, Denmark (F.D.).'}, {'ForeName': 'Hillary', 'Initials': 'H', 'LastName': 'Mulder', 'Affiliation': 'Duke Clinical Research Institute, Duke University, Durham, NC (F.D., H.M., D.M.W., R.D.L., J.H.A., J.B.W., C.B.G., S.M.A-K.).'}, {'ForeName': 'Daniel M', 'Initials': 'DM', 'LastName': 'Wojdyla', 'Affiliation': 'Duke Clinical Research Institute, Duke University, Durham, NC (F.D., H.M., D.M.W., R.D.L., J.H.A., J.B.W., C.B.G., S.M.A-K.).'}, {'ForeName': 'Renato D', 'Initials': 'RD', 'LastName': 'Lopes', 'Affiliation': 'Duke Clinical Research Institute, Duke University, Durham, NC (F.D., H.M., D.M.W., R.D.L., J.H.A., J.B.W., C.B.G., S.M.A-K.).'}, {'ForeName': 'Claes', 'Initials': 'C', 'LastName': 'Held', 'Affiliation': 'Department of Medical Sciences, Cardiology, and Uppsala Clinical Research Center, Uppsala University, Sweden (C.H., L.W.).'}, {'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'Alexander', 'Affiliation': 'Duke Clinical Research Institute, Duke University, Durham, NC (F.D., H.M., D.M.W., R.D.L., J.H.A., J.B.W., C.B.G., S.M.A-K.).'}, {'ForeName': 'Raffaele', 'Initials': 'R', 'LastName': 'De Caterina', 'Affiliation': 'Institute of Cardiology, University of Pisa, Italy (R.D.).'}, {'ForeName': 'Jeffrey B', 'Initials': 'JB', 'LastName': 'Washam', 'Affiliation': 'Duke Clinical Research Institute, Duke University, Durham, NC (F.D., H.M., D.M.W., R.D.L., J.H.A., J.B.W., C.B.G., S.M.A-K.).'}, {'ForeName': 'Elaine M', 'Initials': 'EM', 'LastName': 'Hylek', 'Affiliation': 'Boston University School of Medicine, MA (E.M.H.).'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Garcia', 'Affiliation': 'University of Washington School of Medicine, Seattle, (D.A.G.).'}, {'ForeName': 'Bernard J', 'Initials': 'BJ', 'LastName': 'Gersh', 'Affiliation': 'Mayo Clinic College of Medicine, Rochester, MN (B.J.G.).'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Wallentin', 'Affiliation': 'Department of Medical Sciences, Cardiology, and Uppsala Clinical Research Center, Uppsala University, Sweden (C.H., L.W.).'}, {'ForeName': 'Christopher B', 'Initials': 'CB', 'LastName': 'Granger', 'Affiliation': 'Duke Clinical Research Institute, Duke University, Durham, NC (F.D., H.M., D.M.W., R.D.L., J.H.A., J.B.W., C.B.G., S.M.A-K.).'}, {'ForeName': 'Sana M', 'Initials': 'SM', 'LastName': 'Al-Khatib', 'Affiliation': 'Duke Clinical Research Institute, Duke University, Durham, NC (F.D., H.M., D.M.W., R.D.L., J.H.A., J.B.W., C.B.G., S.M.A-K.).'}]",Circulation,['10.1161/CIRCULATIONAHA.119.041296'] 1209,30146148,Relapse/Recurrence Prevention in Major Depressive Disorder: 26-Month Follow-Up of Mindfulness-Based Cognitive Therapy Versus an Active Control.,"We conducted a 26-month follow-up of a previously reported 12-month study that compared mindfulness-based cognitive therapy (MBCT) to a rigorous active control condition (ACC) for depressive relapse/recurrence prevention and improvements in depressive symptoms and life satisfaction. Participants in remission from major depression were randomized to an 8-week MBCT group (n = 46) or the ACC (n = 46). Outcomes were assessed at baseline; postintervention; and 6, 12, and 26 months. Intention-to-treat analyses indicated no differences between groups for any outcome over the 26-month follow-up. Time to relapse results (MBCT vs. ACC) indicated a hazard ratio = .82, 95% CI [.34, 1.99]. Relapse rates were 47.8% for MBCT and 50.0% for ACC. Piecewise analyses indicated that steeper declines in depressive symptoms in the MBCT vs. the ACC group from postintervention to 12 months were not maintained after 12 months. Both groups experienced a marginally significant rebound of depressive symptoms after 12 months but were still improved at 26 months compared to baseline (b = -4.12, p <= .008). Results for life satisfaction were similar. In sum, over a 26-month follow-up, MBCT was no more effective for preventing depression relapse/recurrence, reducing depressive symptoms, or improving life satisfaction than a rigorous ACC. Based on epidemiological data and evidence from prior depression prevention trials, we discuss the possibility that both MBCT and ACC confer equal therapeutic benefit. Future studies that include treatment as usual (TAU) control conditions are needed to confirm this possibility and to rule out the potential role of time-related effects. Overall findings underscore the importance of comparing MBCT to TAU as well as to ACCs.",2018,"Both groups experienced a marginally significant rebound of depressive symptoms after 12 months but were still improved at 26 months compared to baseline (b = -4.12, p <= .008).","['Participants in remission from major depression', 'Major Depressive Disorder']","['26-Month Follow-Up of Mindfulness-Based Cognitive Therapy Versus an Active Control', 'MBCT', 'mindfulness-based cognitive therapy (MBCT', 'ACC', 'MBCT and ACC']","['life satisfaction', 'depressive symptoms', 'Relapse rates', 'depression relapse/recurrence, reducing depressive symptoms, or improving life satisfaction', 'depressive symptoms and life satisfaction']","[{'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}]","[{'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}]",,0.0584341,"Both groups experienced a marginally significant rebound of depressive symptoms after 12 months but were still improved at 26 months compared to baseline (b = -4.12, p <= .008).","[{'ForeName': 'Amanda J', 'Initials': 'AJ', 'LastName': 'Shallcross', 'Affiliation': 'New York University School of Medicine. Electronic address: amanda.shallcross@nyumc.org.'}, {'ForeName': 'Emily C', 'Initials': 'EC', 'LastName': 'Willroth', 'Affiliation': 'University of California, Berkeley.'}, {'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'Fisher', 'Affiliation': 'University of California, Berkeley.'}, {'ForeName': 'Sona', 'Initials': 'S', 'LastName': 'Dimidjian', 'Affiliation': 'University of Colorado, Boulder.'}, {'ForeName': 'James J', 'Initials': 'JJ', 'LastName': 'Gross', 'Affiliation': 'Stanford University.'}, {'ForeName': 'Pallavi D', 'Initials': 'PD', 'LastName': 'Visvanathan', 'Affiliation': 'Manhattan Mindfulness-Based Cognitive Behavioral Therapy.'}, {'ForeName': 'Iris B', 'Initials': 'IB', 'LastName': 'Mauss', 'Affiliation': 'University of California, Berkeley.'}]",Behavior therapy,['10.1016/j.beth.2018.02.001'] 1210,30639153,Speech Pathology Intervention for Chronic Refractory Cough: A Pilot Study Examining the Benefit of Using Prerecorded Videos as an Adjunct to Therapy.,"Speech pathology intervention is effective for chronic refractory cough (CRC). Speech pathology treatment for CRC includes therapy exercises to teach cough suppression and reduce laryngeal closure during respiration. AIM The aim of this study was to evaluate the benefit of providing patients with supplemental pre-recorded videos of speech pathology exercises for chronic refractory cough (CRC) to assist with patients' independent practice. These videos were pre-made recordings of the treating speech pathologist demonstrating specific exercises for chronic cough suppression. METHOD This study was a prospective randomized controlled trial design. Participants included 18 adult patients attending a speech pathology outpatient clinic in a tertiary referral hospital for treatment of CRC. Participants were randomized to receive either standard speech pathology intervention (SPI) for CRC combined with supplemental pre-recorded videos for home practice or standard SPI alone. The primary outcome measure was a rating of accuracy during demonstration of the speech pathology exercises for cough suppression. This rating was assigned by the treating speech pathologist from session 2 onwards. The treating speech pathologist asked the patient to demonstrate the exercises they had been practising since the last speech pathology session. Secondary outcome measures included the Symptom Frequency and Severity Rating Scale, Leicester Cough Questionnaire, and Consensus Auditory Perceptual Evaluation of Voice. RESULTS There was a significant pre- to post-treatment improvement in both groups however the degree of improvement was not significantly different between the two groups. CONCLUSION The addition of supplemental pre-recorded videos of SPI for CRC did not lead to greater accuracy of therapy exercise practice or superior treatment outcomes than standard SPI alone. DECLARATION OF INTEREST There are no interests to declare.",2020,"to post-treatment improvement in both groups however the degree of improvement was not significantly different between the two groups. ","['chronic refractory cough (CRC', 'Participants included 18 adult patients attending a speech pathology outpatient clinic in a tertiary referral hospital for treatment of CRC', 'Chronic Refractory Cough']","['standard speech pathology intervention (SPI) for CRC combined with supplemental pre-recorded videos for home practice or standard SPI alone', 'Speech Pathology Intervention', 'supplemental pre-recorded videos of speech pathology exercises', 'Speech pathology intervention']","['rating of accuracy during demonstration of the speech pathology exercises for cough suppression', 'Symptom Frequency and Severity Rating Scale, Leicester Cough Questionnaire, and Consensus Auditory Perceptual Evaluation of Voice']","[{'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0010200', 'cui_str': 'Complaining of cough (finding)'}, {'cui': 'C0170127', 'cui_str': 'Calcibiotic Root Canal Sealer'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0080355', 'cui_str': 'Pathology, Speech'}, {'cui': 'C0002424', 'cui_str': 'Outpatient Clinics'}, {'cui': 'C0587437', 'cui_str': 'Tertiary Hospital'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0080355', 'cui_str': 'Pathology, Speech'}, {'cui': 'C0170127', 'cui_str': 'Calcibiotic Root Canal Sealer'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0080355', 'cui_str': 'Pathology, Speech'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0522046', 'cui_str': 'Cough suppression (finding)'}, {'cui': 'C0436350', 'cui_str': 'Symptom frequency (observable entity)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0222045'}, {'cui': 'C0010200', 'cui_str': 'Complaining of cough (finding)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C4274490', 'cui_str': 'Consensus Auditory-Perceptual Evaluation of Voice (assessment scale)'}]",18.0,0.0412744,"to post-treatment improvement in both groups however the degree of improvement was not significantly different between the two groups. ","[{'ForeName': 'Sarah L', 'Initials': 'SL', 'LastName': 'Kapela', 'Affiliation': 'John Hunter Hospital, Hunter Medical Research Institute, New Castle, Australia. Electronic address: sarah.kapela@hnehealth.nsw.gov.au.'}, {'ForeName': 'Anne E', 'Initials': 'AE', 'LastName': 'Vertigan', 'Affiliation': 'John Hunter Hospital, Hunter Medical Research Institute, University of Newcastle, New Castle, Australia.'}, {'ForeName': 'Peter G', 'Initials': 'PG', 'LastName': 'Gibson', 'Affiliation': 'John Hunter Hospital, Hunter Medical Research Institute, University of Newcastle, New Castle, Australia.'}]",Journal of voice : official journal of the Voice Foundation,['10.1016/j.jvoice.2018.12.002'] 1211,31679866,Recurrent herpes zoster in the Shingles Prevention Study: Are second episodes caused by the same varicella-zoster virus strain?,"Herpes zoster (HZ) is caused by reactivation of varicella zoster virus (VZV) that established latency in sensory and autonomic neurons during primary infection. In the Shingles Prevention Study (SPS), a large efficacy trial of live attenuated Oka/Merck zoster vaccine (ZVL), PCR-confirmed second episodes of HZ occurred in two of 660 placebo and one of 321 ZVL recipients with documented HZ during a mean follow-up of 3.13 years. An additional two ZVL recipients experienced a second episode of HZ in the Long-Term Persistence Substudy. All episodes of HZ were caused by wild-type VZV. The first and second episodes of HZ occurred in different dermatomes in each of these five participants, with contralateral recurrences in two. Time between first and second episodes ranged from 12 to 28 months. One of the five participants, who was immunocompetent on study enrollment, was immunocompromised at the onset of his first and second episodes of HZ. VZV DNA isolated from rash lesions from the first and second episodes of HZ was used to sequence the full-length VZV genomes. For the unique-sequence regions of the VZV genome, we employed target enrichment of VZV DNA, followed by deep sequencing. For the reiteration regions, we used PCR amplification and Sanger sequencing. Our analysis and comparison of the VZV genomes from the first and second episodes of HZ in each of the five participants indicate that both episodes were caused by the same VZV strain. This is consistent with the extraordinary stability of VZV during the replication phase of varicella and the subsequent establishment of latency in sensory ganglia throughout the body. Our observations also indicate that VZV is stable during the persistence of latency and the subsequent reactivation and replication that results in HZ.",2020,"The first and second episodes of HZ occurred in different dermatomes in each of these five participants, with contralateral recurrences in two.","['321 ZVL recipients with documented HZ during a mean follow-up of 3.13\u202fyears', 'Recurrent herpes zoster in the Shingles Prevention Study']","['Herpes zoster (HZ', 'live attenuated Oka/Merck zoster vaccine (ZVL']","['second episode of HZ', 'HZ', 'contralateral recurrences']","[{'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0019360', 'cui_str': 'Shingles'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0019360', 'cui_str': 'Shingles'}, {'cui': 'C0332161', 'cui_str': 'Attenuated by (contextual qualifier) (qualifier value)'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}]","[{'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0441988', 'cui_str': 'Contralateral (qualifier value)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}]",,0.0247747,"The first and second episodes of HZ occurred in different dermatomes in each of these five participants, with contralateral recurrences in two.","[{'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Harbecke', 'Affiliation': 'Department of Veterans Affairs (VA) San Diego Healthcare System, San Diego, CA, USA; Department of Medicine, University of California San Diego, San Diego, CA, USA. Electronic address: rharbecke@ucsd.edu.'}, {'ForeName': 'Nancy J', 'Initials': 'NJ', 'LastName': 'Jensen', 'Affiliation': 'Centers for Disease Control and Prevention, Division of Viral Diseases, Atlanta, GA, USA.'}, {'ForeName': 'Daniel P', 'Initials': 'DP', 'LastName': 'Depledge', 'Affiliation': 'Division of Infection and Immunity, University College London, London, UK; Department of Medicine, New York University School of Medicine, New York, NY, USA.'}, {'ForeName': 'Gary R', 'Initials': 'GR', 'LastName': 'Johnson', 'Affiliation': 'Cooperative Studies Program Coordinating Center, Veterans Affairs Connecticut Healthcare System, West Haven, CT, USA.'}, {'ForeName': 'Mark E', 'Initials': 'ME', 'LastName': 'Ashbaugh', 'Affiliation': 'Department of Veterans Affairs (VA) San Diego Healthcare System, San Diego, CA, USA.'}, {'ForeName': 'D Scott', 'Initials': 'DS', 'LastName': 'Schmid', 'Affiliation': 'Centers for Disease Control and Prevention, Division of Viral Diseases, Atlanta, GA, USA.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Breuer', 'Affiliation': 'Division of Infection and Immunity, University College London, London, UK.'}, {'ForeName': 'Myron J', 'Initials': 'MJ', 'LastName': 'Levin', 'Affiliation': 'Department of Medicine and Department of Pediatrics, University of Colorado, Anschutz Medical Campus, Aurora, CO, USA.'}, {'ForeName': 'Michael N', 'Initials': 'MN', 'LastName': 'Oxman', 'Affiliation': 'Department of Veterans Affairs (VA) San Diego Healthcare System, San Diego, CA, USA; Department of Medicine, University of California San Diego, San Diego, CA, USA.'}]",Vaccine,['10.1016/j.vaccine.2019.10.038'] 1212,30570813,A parent intervention with a growth mindset approach improves children's early gesture and vocabulary development.,"Socioeconomic disparities in children's early vocabulary skills can be traced back to disparities in gesture use at age one and are due, in part, to the quantity and quality of communication children are exposed to by parents. Further, parents' mindsets about intelligence contribute to their interactions with their children. We implemented a parent gesture intervention with a growth mindset component with 47 parents of 10-month-olds to determine whether this approach would increase parents' use of the pointing gesture, infants' use of pointing, and child vocabulary growth. The intervention had an effect on parent gesture such that by child age 12-months, parents who received the intervention increased in their pointing more than parents in the control condition. Importantly, the intervention also had a significant effect on child gesture use with parents. There was no main effect of the intervention on child vocabulary. Further, the effect of the intervention on pointing was stronger for parents who endorsed fixed mindsets at baseline, and had an added benefit of increased vocabulary growth from 10-18 months for children of those parents who endorsed fixed mindsets. Incorporating growth mindset approaches into parenting interventions is encouraged.",2019,"The intervention had an effect on parent gesture such that by child age 12-months, parents who received the intervention increased in their pointing more than parents in the control condition.",['with 47 parents of 10-month-olds'],"['parent gesture intervention with a growth mindset component', 'growth mindset approach']","[""children's early gesture and vocabulary development"", 'child gesture use', 'child vocabulary']","[{'cui': 'C0030551', 'cui_str': 'Parent of (observable entity)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0017510', 'cui_str': 'Gestures'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0017510', 'cui_str': 'Gestures'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C1947944', 'cui_str': 'Use'}]",,0.0185988,"The intervention had an effect on parent gesture such that by child age 12-months, parents who received the intervention increased in their pointing more than parents in the control condition.","[{'ForeName': 'Meredith L', 'Initials': 'ML', 'LastName': 'Rowe', 'Affiliation': 'Graduate School of Education, Harvard University, Cambridge, Massachusetts.'}, {'ForeName': 'Kathryn A', 'Initials': 'KA', 'LastName': 'Leech', 'Affiliation': 'Graduate School of Education, Harvard University, Cambridge, Massachusetts.'}]",Developmental science,['10.1111/desc.12792'] 1213,29988125,Verapamil and beta cell function in adults with recent-onset type 1 diabetes.,"Pancreatic beta cell loss is a key factor in the pathogenesis of type 1 diabetes (T1D), but therapies to halt this process are lacking. We previously reported that the approved antihypertensive calcium-channel blocker verapamil, by decreasing the expression of thioredoxin-interacting protein, promotes the survival of insulin-producing beta cells and reverses diabetes in mouse models 1 . To translate these findings into humans, we conducted a randomized double-blind placebo-controlled phase 2 clinical trial ( NCT02372253 ) to assess the efficacy and safety of oral verapamil added for 12 months to a standard insulin regimen in adult subjects with recent-onset T1D. Verapamil treatment, compared with placebo was well tolerated and associated with an improved mixed-meal-stimulated C-peptide area under the curve, a measure of endogenous beta cell function, at 3 and 12 months (prespecified primary endpoint), as well as with a lower increase in insulin requirements, fewer hypoglycemic events and on-target glycemic control (secondary endpoints). Thus, addition of once-daily oral verapamil may be a safe and effective novel approach to promote endogenous beta cell function and reduce insulin requirements and hypoglycemic episodes in adult individuals with recent-onset T1D.",2018,"Pancreatic beta cell loss is a key factor in the pathogenesis of type 1 diabetes (T1D), but therapies to halt this process are lacking.","['adult subjects with recent-onset T1D', 'adults with recent-onset type 1 diabetes', 'adult individuals with recent-onset T1D']","['Verapamil', 'placebo', 'verapamil', 'oral verapamil', 'antihypertensive calcium-channel blocker verapamil', 'Verapamil treatment']","['insulin requirements, fewer hypoglycemic events and on-target glycemic control (secondary endpoints', 'efficacy and safety']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0441729', 'cui_str': 'Type 1 (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C0042523', 'cui_str': 'Verapamil'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0003364', 'cui_str': 'Anti-Hypertensive Drugs'}, {'cui': 'C0006684', 'cui_str': 'Calcium Channel Blocking Drugs'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0205388', 'cui_str': 'Few (qualifier value)'}, {'cui': 'C0020616', 'cui_str': 'Hypoglycemic Drugs'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.123525,"Pancreatic beta cell loss is a key factor in the pathogenesis of type 1 diabetes (T1D), but therapies to halt this process are lacking.","[{'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Ovalle', 'Affiliation': 'Comprehensive Diabetes Center, Department of Medicine, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Tiffany', 'Initials': 'T', 'LastName': 'Grimes', 'Affiliation': 'Comprehensive Diabetes Center, Department of Medicine, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Guanlan', 'Initials': 'G', 'LastName': 'Xu', 'Affiliation': 'Comprehensive Diabetes Center, Department of Medicine, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Anish J', 'Initials': 'AJ', 'LastName': 'Patel', 'Affiliation': 'Comprehensive Diabetes Center, Department of Medicine, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Truman B', 'Initials': 'TB', 'LastName': 'Grayson', 'Affiliation': 'Comprehensive Diabetes Center, Department of Medicine, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Lance A', 'Initials': 'LA', 'LastName': 'Thielen', 'Affiliation': 'Comprehensive Diabetes Center, Department of Medicine, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Li', 'Affiliation': 'Department of Biostatistics, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Anath', 'Initials': 'A', 'LastName': 'Shalev', 'Affiliation': 'Comprehensive Diabetes Center, Department of Medicine, University of Alabama at Birmingham, Birmingham, AL, USA. shalev@uab.edu.'}]",Nature medicine,['10.1038/s41591-018-0089-4'] 1214,31720808,Effects of Expiratory Muscle Training and Air Stacking on Peak Cough Flow in Individuals with Parkinson's Disease.,"The purpose of this study was to investigate the effects of air stacking (AS) and an expiratory muscle training (EMT) program to increase voluntary and reflex peak cough flow (PCF) in individuals with Parkinson's disease. Participants were allocated to the control (n = 11), EMT (n = 11), or EMT + AS group (n = 11). All groups performed EMT (5 sets of 5 repetitions), 6 times a week for 2 months. The control group used a fixed resistance, EMT plus AS and EMT groups used a progressively increased resistance. The EMT plus AS group additionally performed 10 series of three to four lung insufflations using a manual resuscitator bag. Voluntary and reflex PCF, maximum expiratory pressure, and slow vital capacity were assessed before and after training. EMT plus AS was more beneficial than EMT alone for improving reflex and voluntary PCF. The effect of the EMT plus AS was greater for reflex PCF than for voluntary PCF.",2020,The effect of the EMT plus AS was greater for reflex PCF than for voluntary PCF.,"[""Individuals with Parkinson's Disease"", ""individuals with Parkinson's disease""]","['fixed resistance, EMT plus AS and EMT', 'air stacking (AS) and an expiratory muscle training (EMT) program', 'EMT', 'Expiratory Muscle Training and Air Stacking', 'EMT\u2009+\u2009AS']","['Peak Cough Flow', 'reflex and voluntary PCF', 'Voluntary and reflex PCF, maximum expiratory pressure, and slow vital capacity', 'voluntary and reflex peak cough flow (PCF']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0030567', 'cui_str': 'Idiopathic Parkinson Disease'}]","[{'cui': 'C0443218', 'cui_str': 'Fixed (qualifier value)'}, {'cui': 'C0013963', 'cui_str': 'Emergency Medicine Technicians'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0231800', 'cui_str': 'Exhalation'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0010200', 'cui_str': 'Complaining of cough (finding)'}, {'cui': 'C0034929', 'cui_str': 'Reflex'}, {'cui': 'C0439656', 'cui_str': 'Voluntary (qualifier value)'}, {'cui': 'C0232022', 'cui_str': 'Maximum expiratory pressure (observable entity)'}, {'cui': 'C0231957', 'cui_str': 'Slow vital capacity (observable entity)'}]",,0.0114835,The effect of the EMT plus AS was greater for reflex PCF than for voluntary PCF.,"[{'ForeName': 'Alvaro', 'Initials': 'A', 'LastName': 'Reyes', 'Affiliation': 'Escuela de Kinesiología, Facultad de Ciencias de La Rehabilitación, Universidad Andres Bello, Quillota 980, Viña del Mar, Chile. alvaroreyesponce@gmail.com.'}, {'ForeName': 'Adrián', 'Initials': 'A', 'LastName': 'Castillo', 'Affiliation': 'Carrera de Fonoaudiología, Departamento Ciencias de la Salud, Facultad de Medicina, Pontificia Universidad Católica de Chile, Santiago, Chile.'}, {'ForeName': 'Javiera', 'Initials': 'J', 'LastName': 'Castillo', 'Affiliation': 'Escuela de Fonoaudiología, Facultad de Ciencias, Universidad Mayor, Santiago, Chile.'}]",Lung,['10.1007/s00408-019-00291-8'] 1215,29031894,Refractory urgency urinary incontinence treatment in women: impact of age on outcomes and complications.,"BACKGROUND Women with refractory urgency urinary incontinence (ie, unresponsive to behavioral and pharmacological interventions) are treated with onabotulinumtoxinA or sacral neuromodulation. OBJECTIVE The objective of the study was to compare treatment efficacy and adverse events in women <65 and ≥65 years old treated with onabotulinumtoxinA or sacral neuromodulation. STUDY DESIGN This study was a planned secondary analysis of a multicenter, randomized trial that enrolled community-dwelling women with refractory urgency urinary incontinence to onabotulinumtoxinA or sacral neuromodulation treatments. The primary outcome was a change in mean daily urgency urinary incontinence episodes on a bladder diary over 6 months. Secondary outcomes included ≥75% urgency urinary incontinence episode reduction, change in symptom severity/quality of life, treatment satisfaction, and treatment-related adverse events. RESULTS Both age groups experienced improvement in mean urgency urinary incontinence episodes per day following each treatment. There was no evidence that mean daily urgency urinary incontinence episode reduction differed between age groups for onabotulinumtoxinA (adjusted coefficient, -0.127, 95% confidence interval, -1.233 to 0.979; P = .821) or sacral neuromodulation (adjusted coefficient, -0.698, 95% confidence interval, -1.832 to 0.437; P = .227). Among those treated with onabotulinumtoxinA, women <65 years had 3.3-fold greater odds of ≥75% resolution than women ≥65 years (95% confidence interval, 1.56 -7.02). Women <65 years had a greater reduction in Overactive Bladder Questionnaire Short Form symptom bother scores compared with women ≥65 years by 7.49 points (95% confidence interval, -3.23 to -11.74), regardless of treatment group. There was no difference between quality of life improvement by age. Women ≥65 years had more urinary tract infections following onabotulinumtoxinA and sacral neuromodulation (odds ratio, 1.9, 95% confidence interval, 1.2-3.3). There was no evidence of age differences in sacral neuromodulation revision/removal or catheterization following onabotulinumtoxinA treatment. CONCLUSION Younger women experienced greater absolute continence, symptom improvement, and fewer urinary tract infections; both older and younger women had beneficial urgency urinary incontinence episode reduction, similar rates of other treatment adverse events, and improved quality of life.",2018,"There was no evidence that mean daily urgency urinary incontinence episode reduction differed between age groups for onabotulinumtoxinA (adjusted coefficient, -0.127, 95% confidence interval, -1.233 to 0.979; P = .821) or sacral neuromodulation (adjusted coefficient, -0.698, 95% confidence interval, -1.832 to 0.437; P = .227).","['enrolled community-dwelling women with refractory urgency urinary incontinence to onabotulinumtoxinA or sacral neuromodulation treatments', 'Women with refractory urgency urinary incontinence (ie, unresponsive to behavioral and pharmacological interventions', 'Refractory urgency urinary incontinence treatment in women', 'women <65 and ≥65 years old treated with onabotulinumtoxinA or sacral neuromodulation']","['onabotulinumtoxinA or sacral neuromodulation', 'onabotulinumtoxinA']","['sacral neuromodulation', 'Overactive Bladder Questionnaire Short Form symptom bother scores', 'beneficial urgency urinary incontinence episode reduction, similar rates of other treatment adverse events', 'mean daily urgency urinary incontinence episode reduction', '≥75% urgency urinary incontinence episode reduction, change in symptom severity/quality of life, treatment satisfaction, and treatment-related adverse events', 'quality of life', 'absolute continence, symptom improvement, and fewer urinary tract infections', 'change in mean daily urgency urinary incontinence episodes on a bladder diary', 'mean urgency urinary incontinence episodes', 'quality of life improvement', 'urinary tract infections']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0439609', 'cui_str': 'Urgency (qualifier value)'}, {'cui': 'C0042024', 'cui_str': 'Urinary Incontinence'}, {'cui': 'C2719767', 'cui_str': 'onabotulinumtoxinA'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0237284', 'cui_str': 'Unresponsive'}, {'cui': 'C0205464', 'cui_str': 'Pharmacologic (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}]","[{'cui': 'C2719767', 'cui_str': 'onabotulinumtoxinA'}]","[{'cui': 'C0878773', 'cui_str': 'Overactive Bladder'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439609', 'cui_str': 'Urgency (qualifier value)'}, {'cui': 'C0042024', 'cui_str': 'Urinary Incontinence'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}, {'cui': 'C0205388', 'cui_str': 'Few (qualifier value)'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease (disorder)'}, {'cui': 'C0430970', 'cui_str': 'Urinary frequency volume chart (procedure)'}]",,0.187503,"There was no evidence that mean daily urgency urinary incontinence episode reduction differed between age groups for onabotulinumtoxinA (adjusted coefficient, -0.127, 95% confidence interval, -1.233 to 0.979; P = .821) or sacral neuromodulation (adjusted coefficient, -0.698, 95% confidence interval, -1.832 to 0.437; P = .227).","[{'ForeName': 'Yuko M', 'Initials': 'YM', 'LastName': 'Komesu', 'Affiliation': 'University of New Mexico Health Sciences Center, Albuquerque, NM. Electronic address: ykomesu@salud.unm.edu.'}, {'ForeName': 'Cindy L', 'Initials': 'CL', 'LastName': 'Amundsen', 'Affiliation': 'Duke University, Durham, NC.'}, {'ForeName': 'Holly E', 'Initials': 'HE', 'LastName': 'Richter', 'Affiliation': 'University of Alabama at Birmingham, Birmingham, AL.'}, {'ForeName': 'Stephen W', 'Initials': 'SW', 'LastName': 'Erickson', 'Affiliation': 'RTI International, Research Triangle Park, NC.'}, {'ForeName': 'Mary F', 'Initials': 'MF', 'LastName': 'Ackenbom', 'Affiliation': 'University of Pittsburgh Medical Center, Philadelphia, PA.'}, {'ForeName': 'Uduak U', 'Initials': 'UU', 'LastName': 'Andy', 'Affiliation': 'University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Vivian W', 'Initials': 'VW', 'LastName': 'Sung', 'Affiliation': 'Women and Infants Hospital of Rhode Island, Providence, RI.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Albo', 'Affiliation': 'University of California, San Diego, San Diego, CA.'}, {'ForeName': 'W Thomas', 'Initials': 'WT', 'LastName': 'Gregory', 'Affiliation': 'Oregon Health and Science University, Portland, OR.'}, {'ForeName': 'Marie Fidela', 'Initials': 'MF', 'LastName': 'Paraiso', 'Affiliation': 'Cleveland Clinic, Cleveland, OH.'}, {'ForeName': 'Dennis', 'Initials': 'D', 'LastName': 'Wallace', 'Affiliation': 'RTI International, Research Triangle Park, NC.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American journal of obstetrics and gynecology,['10.1016/j.ajog.2017.10.006'] 1216,30608593,A comparison of hospital episode statistics and traditional methods to identify outcomes in a randomized trial; a sub-study of HEAT-PPCI.,"BACKGROUND This study aims to compare information from hospital episode statistics (HES) and traditional direct patient contact to identify readmission and clinical events in the follow-up of a randomized controlled trial (RCT). METHODS The study followed 1812 patients for 28 days using direct contact (DC). In addition, we obtained HES for this period. We examined medical records for all suspected readmissions and determined confirmed events by adjudication. We compared the ability of the individual DC and HES methods to determine readmission and the occurrence of trial-specific events, confirmed at adjudication. RESULTS In the ascertainment of readmission, compared to DC, HES demonstrated a trend towards better sensitivity (identifying 153/166 = 92.2% versus 144/166 = 86.7%; difference = 5.4%, 95% CI: 0.1-11.5%) and better specificity (1492/1492 = 100% versus 1426/1492 = 95.5%; difference = 4.4%, 95% CI: 4.2-5.6%).An examination of HES coding does not identify rates for specific events that match those from adjudication, with limitations in both sensitivity and specificity. CONCLUSION HES is effective in the ascertainment of readmission and is a useful tool in follow-up. Information from HES provides a reflection of a patient's course and associated cost, as perceived by the healthcare system. Future studies could modify outcome definitions to reflect episode coding.",2020,"In the ascertainment of readmission, compared to DC, HES demonstrated a trend towards better sensitivity (identifying 153/166 = 92.2% versus 144/166 = 86.7%; difference = 5.4%, 95% CI: 0.1-11.5%) and better specificity (1492/1492 = 100% versus 1426/1492 = 95.5%; difference = 4.4%, 95% CI: 4.2-5.6%).",['1812 patients for 28 days using direct contact (DC'],"['HES', 'HEAT-PPCI']","['better specificity', 'better sensitivity']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}]","[{'cui': 'C0018837', 'cui_str': 'Heat'}]","[{'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0037791', 'cui_str': 'Specificity'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}]",1812.0,0.14429,"In the ascertainment of readmission, compared to DC, HES demonstrated a trend towards better sensitivity (identifying 153/166 = 92.2% versus 144/166 = 86.7%; difference = 5.4%, 95% CI: 0.1-11.5%) and better specificity (1492/1492 = 100% versus 1426/1492 = 95.5%; difference = 4.4%, 95% CI: 4.2-5.6%).","[{'ForeName': 'Sarah R', 'Initials': 'SR', 'LastName': 'Blake', 'Affiliation': 'Institute of Cardiovascular Medicine and Science, Liverpool Heart and Chest Hospital, Thomas Drive, Liverpool L14 3PE, UK.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Roome', 'Affiliation': 'John Radcliffe Hospital, Headley Way, Headington, Oxford OX3 9DU, UK.'}, {'ForeName': 'Adeel', 'Initials': 'A', 'LastName': 'Shahzad', 'Affiliation': 'Manchester University NHS Foundation Trust, Southmoor Rd, Wythenshawe, Manchester M23 9LT, UK.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Kemp', 'Affiliation': 'Institute of Cardiovascular Medicine and Science, Liverpool Heart and Chest Hospital, Thomas Drive, Liverpool L14 3PE, UK.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Mars', 'Affiliation': 'Institute of Cardiovascular Medicine and Science, Liverpool Heart and Chest Hospital, Thomas Drive, Liverpool L14 3PE, UK.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Wilson', 'Affiliation': 'Institute of Cardiovascular Medicine and Science, Liverpool Heart and Chest Hospital, Thomas Drive, Liverpool L14 3PE, UK.'}, {'ForeName': 'Rod H', 'Initials': 'RH', 'LastName': 'Stables', 'Affiliation': 'Institute of Cardiovascular Medicine and Science, Liverpool Heart and Chest Hospital, Thomas Drive, Liverpool L14 3PE, UK.'}]","Journal of public health (Oxford, England)",['10.1093/pubmed/fdy225'] 1217,25943999,Memory training plus yoga for older adults.,"Previous tests of the SeniorWISE intervention with community-residing older adults that were designed to improve affect and cognitive performance were successful and positively affected these outcomes. In this study, we tested whether adding yoga to the intervention would affect the outcomes. Using a quasiexperimental pre-post design, we delivered 12 hours of SeniorWISE memory training that included a 30-minute yoga component before each training session. The intervention was based on the four components of self-efficacy theory: enactive mastery experience, vicarious experience, verbal persuasion, and physiologic arousal. We recruited 133 older adults between the ages of 53 and 96 years from four retirement communities in Central Texas. Individuals were screened and tested and then attended training sessions two times a week over 4 weeks. A septuagenarian licensed psychologist taught the memory training, and a certified yoga instructor taught yoga. Eighty-three participants completed at least 9 hours (75%) of the training and completed the posttest. Those individuals who completed made significant gains in memory performance, instrumental activities of daily living, and memory self-efficacy and had fewer depressive symptoms. Thirteen individuals advanced from poor to normal memory performance, and seven improved from impaired to poor memory performance; thus, 20 individuals improved enough to advance to a higher functioning memory group. The findings from this study of a memory training intervention plus yoga training show that the benefits of multifactorial interventions had additive benefits. The combined treatments offer a unique model for brain health programs and the promotion of nonpharmacological treatment with the goals of maintaining healthy brain function and boosting brain plasticity.",2015,"Those individuals who completed made significant gains in memory performance, instrumental activities of daily living, and memory self-efficacy and had fewer depressive symptoms.","['133 older adults between the ages of 53 and 96 years from four retirement communities in Central Texas', 'older adults']","['SeniorWISE intervention', 'Memory training plus yoga']","['depressive symptoms', 'memory performance, instrumental activities of daily living, and memory self-efficacy']","[{'cui': 'C4517563', 'cui_str': '133'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0337650', 'cui_str': 'Living in retirement community (finding)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0039711', 'cui_str': 'Texas'}]","[{'cui': 'C0729377', 'cui_str': 'Memory Training'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1883583', 'cui_str': 'Yoga'}]","[{'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C1285654', 'cui_str': 'Ability to remember'}, {'cui': 'C1290928', 'cui_str': 'Instrumental activity of daily living (observable entity)'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}]",133.0,0.0196284,"Those individuals who completed made significant gains in memory performance, instrumental activities of daily living, and memory self-efficacy and had fewer depressive symptoms.","[{'ForeName': 'Graham J', 'Initials': 'GJ', 'LastName': 'McDougall', 'Affiliation': 'Questions or comments about this article may be directed to Graham J. McDougall Jr., RN PHD FAAN FGSA, at gjmcdougall@ua.edu. He is a Professor and Martha Lucinda Luker Saxon Endowed Chair in Rural Health Nursing, Capstone College of Nursing, The University of Alabama, Tuscaloosa, AL. David E. Vance, PhD MGS, is Associate Director, Center for Nursing Research, School of Nursing, University of Alabama at Birmingham, Birmingham, AL. Ernest Wayde, PhD, is a Clinical Psychologist, Psychology Postdoctoral Fellow, VHA National Center for Organization Development, Cincinnati, OH. Katy Ford, MA, is a PhD Student, Department of Psychology, The University of Alabama, Tuscaloosa, AL. Jeremiah Ross, BSN, is a Staff Nurse, Seton Northwest Hospital, Austin, TX.'}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Vance', 'Affiliation': ''}, {'ForeName': 'Ernest', 'Initials': 'E', 'LastName': 'Wayde', 'Affiliation': ''}, {'ForeName': 'Katy', 'Initials': 'K', 'LastName': 'Ford', 'Affiliation': ''}, {'ForeName': 'Jeremiah', 'Initials': 'J', 'LastName': 'Ross', 'Affiliation': ''}]",The Journal of neuroscience nursing : journal of the American Association of Neuroscience Nurses,['10.1097/JNN.0000000000000133'] 1218,31668592,"Levofloxacin prophylaxis in patients with newly diagnosed myeloma (TEAMM): a multicentre, double-blind, placebo-controlled, randomised, phase 3 trial.","BACKGROUND Myeloma causes profound immunodeficiency and recurrent, serious infections. Around 5500 new cases of myeloma are diagnosed per year in the UK, and a quarter of patients will have a serious infection within 3 months of diagnosis. We aimed to assess whether patients newly diagnosed with myeloma benefit from antibiotic prophylaxis to prevent infection, and to investigate the effect on antibiotic-resistant organism carriage and health care-associated infections in patients with newly diagnosed myeloma. METHODS TEAMM was a prospective, multicentre, double-blind, placebo-controlled randomised trial in patients aged 21 years and older with newly diagnosed myeloma in 93 UK hospitals. All enrolled patients were within 14 days of starting active myeloma treatment. We randomly assigned patients (1:1) to levofloxacin or placebo with a computerised minimisation algorithm. Allocation was stratified by centre, estimated glomerular filtration rate, and intention to proceed to high-dose chemotherapy with autologous stem cell transplantation. All investigators, patients, laboratory, and trial co-ordination staff were masked to the treatment allocation. Patients were given 500 mg of levofloxacin (two 250 mg tablets), orally once daily for 12 weeks, or placebo tablets (two tablets, orally once daily for 12 weeks), with dose reduction according to estimated glomerular filtration rate every 4 weeks. Follow-up visits occurred every 4 weeks up to week 16, and at 1 year. The primary outcome was time to first febrile episode or death from all causes within the first 12 weeks of trial treatment. All randomised patients were included in an intention-to-treat analysis of the primary endpoint. This study is registered with the ISRCTN registry, number ISRCTN51731976, and the EU Clinical Trials Register, number 2011-000366-35. FINDINGS Between Aug 15, 2012, and April 29, 2016, we enrolled and randomly assigned 977 patients to receive levofloxacin prophylaxis (489 patients) or placebo (488 patients). Median follow-up was 12 months (IQR 8-13). 95 (19%) first febrile episodes or deaths occurred in 489 patients in the levofloxacin group versus 134 (27%) in 488 patients in the placebo group (hazard ratio 0·66, 95% CI 0·51-0·86; p=0·0018. 597 serious adverse events were reported up to 16 weeks from the start of trial treatment (308 [52%] of which were in the levofloxacin group and 289 [48%] of which were in the placebo group). Serious adverse events were similar between the two groups except for five episodes (1%) of mostly reversible tendonitis in the levofloxacin group. INTERPRETATION Addition of prophylactic levofloxacin to active myeloma treatment during the first 12 weeks of therapy significantly reduced febrile episodes and deaths compared with placebo without increasing health care-associated infections. These results suggest that prophylactic levofloxacin could be used for patients with newly diagnosed myeloma undergoing anti-myeloma therapy. FUNDING UK National Institute for Health Research.",2019,"Serious adverse events were similar between the two groups except for five episodes (1%) of mostly reversible tendonitis in the levofloxacin group. ","['patients with newly diagnosed myeloma undergoing anti-myeloma therapy', 'patients with newly diagnosed myeloma', 'patients aged 21 years and older with newly diagnosed myeloma in 93 UK hospitals', 'patients newly diagnosed with myeloma benefit from', '488 patients', 'patients with newly diagnosed myeloma (TEAMM', '489 patients) or', 'number 2011-000366-35.\nFINDINGS\n\n\nBetween Aug 15, 2012, and April 29, 2016, we enrolled and randomly assigned 977 patients to receive']","['levofloxacin prophylaxis', 'levofloxacin or placebo', 'levofloxacin', 'placebo tablets', 'placebo', 'prophylactic levofloxacin', 'chemotherapy with autologous stem cell transplantation', 'antibiotic prophylaxis', 'Levofloxacin prophylaxis']","['febrile episodes or deaths', '597 serious adverse events', 'time to first febrile episode or death', 'Serious adverse events', 'febrile episodes and deaths']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0026764', 'cui_str': 'Myelomatosis'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C2607943', 'cui_str': 'findings'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}]","[{'cui': 'C0282386', 'cui_str': 'Levofloxacin'}, {'cui': 'C0033107', 'cui_str': 'prophylaxis'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}, {'cui': 'C0445202', 'cui_str': 'Prophylactic (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C1504389', 'cui_str': 'Stem Cell Transplantation'}, {'cui': 'C0282638', 'cui_str': 'Premedication, Antibiotic'}]","[{'cui': 'C0015967', 'cui_str': 'Hyperthermia'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",977.0,0.742669,"Serious adverse events were similar between the two groups except for five episodes (1%) of mostly reversible tendonitis in the levofloxacin group. ","[{'ForeName': 'Mark T', 'Initials': 'MT', 'LastName': 'Drayson', 'Affiliation': 'School of Immunity and Infection, University of Birmingham, Birmingham, UK. Electronic address: m.t.drayson@bham.ac.uk.'}, {'ForeName': 'Stella', 'Initials': 'S', 'LastName': 'Bowcock', 'Affiliation': ""King's College Hospital NHS Trust, London, UK.""}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Planche', 'Affiliation': ""Department of Medical Microbiology, St George's, University of London, London, UK.""}, {'ForeName': 'Gulnaz', 'Initials': 'G', 'LastName': 'Iqbal', 'Affiliation': 'Warwick Clinical Trials Unit, University of Warwick, Coventry, UK.'}, {'ForeName': 'Guy', 'Initials': 'G', 'LastName': 'Pratt', 'Affiliation': 'University Hospitals Birmingham NHS Trust, Birmingham, UK.'}, {'ForeName': 'Kwee', 'Initials': 'K', 'LastName': 'Yong', 'Affiliation': 'Department of Haematology, UCL Cancer Institute, London, UK.'}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Wood', 'Affiliation': 'Warwick Clinical Trials Unit, University of Warwick, Coventry, UK.'}, {'ForeName': 'Kerry', 'Initials': 'K', 'LastName': 'Raynes', 'Affiliation': 'Warwick Clinical Trials Unit, University of Warwick, Coventry, UK.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Higgins', 'Affiliation': 'Warwick Clinical Trials Unit, University of Warwick, Coventry, UK.'}, {'ForeName': 'Bryony', 'Initials': 'B', 'LastName': 'Dawkins', 'Affiliation': 'Academic Unit of Health Economics, University of Leeds, Leeds, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Meads', 'Affiliation': 'Academic Unit of Health Economics, University of Leeds, Leeds, UK.'}, {'ForeName': 'Claire T', 'Initials': 'CT', 'LastName': 'Hulme', 'Affiliation': 'Academic Unit of Health Economics, University of Leeds, Leeds, UK.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Monahan', 'Affiliation': ""Department of Medical Microbiology, St George's, University of London, London, UK.""}, {'ForeName': 'Kamaraj', 'Initials': 'K', 'LastName': 'Karunanithi', 'Affiliation': 'University Hospitals North Midlands NHS Trust, Stoke On Trent, UK.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Dignum', 'Affiliation': 'Portsmouth Hospitals NHS Trust, Portsmouth, UK.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Belsham', 'Affiliation': 'Portsmouth Hospitals NHS Trust, Portsmouth, UK.'}, {'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Neilson', 'Affiliation': 'The Dudley Group NHS Foundation Trust, Russells Hall Hospital, Dudley, UK.'}, {'ForeName': 'Beth', 'Initials': 'B', 'LastName': 'Harrison', 'Affiliation': 'University Hospitals Coventry and Warwickshire, Coventry, UK.'}, {'ForeName': 'Anand', 'Initials': 'A', 'LastName': 'Lokare', 'Affiliation': 'University Hospitals Coventry and Warwickshire, Coventry, UK.'}, {'ForeName': 'Gavin', 'Initials': 'G', 'LastName': 'Campbell', 'Affiliation': 'East Suffolk and North Essex NHS Foundation Trust, Colchester, UK.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Hamblin', 'Affiliation': 'East Suffolk and North Essex NHS Foundation Trust, Colchester, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Hawkey', 'Affiliation': 'West Midlands Public Health Laboratory, Heart of England NHS Trust, Birmingham, UK.'}, {'ForeName': 'Anna C', 'Initials': 'AC', 'LastName': 'Whittaker', 'Affiliation': 'School of Sport, Exercise and Rehabilitation Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Low', 'Affiliation': 'Patient Advocacy, Myeloma UK, Edinburgh UK.'}, {'ForeName': 'Janet A', 'Initials': 'JA', 'LastName': 'Dunn', 'Affiliation': 'Warwick Clinical Trials Unit, University of Warwick, Coventry, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Oncology,['10.1016/S1470-2045(19)30506-6'] 1219,30609278,"The Effectiveness of Kinesiotaping, Sham Taping or Exercises Only in Lateral Epicondylitis Treatment: A Randomized Controlled Study.","BACKGROUND Lateral epicondylitis is a common musculoskeletal condition presenting with pain and tenderness over the lateral epicondyle and dorsal forearm, pain and weakness in gripping and limitations in daily activities. It is proposed that kinesiotaping, a new application of adhesive taping, reduces pain and improves muscle function. OBJECTIVE To compare efficacy of kinesiotaping, sham taping, or exercises only in the treatment of lateral epicondylitis. DESIGN Double-blind, randomized, controlled trial. SETTING Tertiary medical center, university hospital. PARTICIPANTS Thirty patients with lateral epicondylitis for less than 12 weeks. METHODS OR INTERVENTIONS Patients were randomized into three groups: kinesiotaping plus exercises (n = 10), sham taping plus exercises (n = 10), and control (exercises only) (n = 10) groups. All recipients were provided a home exercise program including strengthening and stretching exercises. In kinesiotaping and sham taping groups, tapings were performed and changed every 3-4 d for 2 weeks. MAIN OUTCOME MEASURE(S) The primary outcome was the patient-rated tennis elbow evaluation (PRTEE). Pain visual analogue scale (VAS), grip strength, and the disabilities of the arm, shoulder and hand (QuickDASH) scales were secondary outcomes. Evaluations were done at baseline, posttreatment, and at 4 weeks after treatment. The immediate effect was also assessed by VAS and grip strength immediately after real and sham tapings. RESULTS PRTEE total scores at posttreatment and at 4 weeks after treatment were statistically significantly lower in kinesiotaping plus exercises group compared to sham taping plus exercises group and exercises only group. The effects of kinesiotaping were larger than sham taping and only exercises at posttreatment (d = -1.21, d = -1.33) and at 4 weeks after treatment (d = -1.39, d = -1.34). Repeated-measures anova showed a significant interaction between the time and the groups (F 2950 = 4849; P = .006). Significant between-group differences were found in QuickDASH score and VAS at rest at 4 weeks after treatment, VAS at daily activity at posttreatment and 4 weeks after treatment when kinesiotaping plus exercises and sham taping plus exercises groups and kinesiotaping plus exercises and exercises only groups were compared. Real taping but not sham taping immediately led to an increase in grip strength, decrease in VAS at rest and VAS at daily activity (P = .0017, P = .041, P = .028; respectively). CONCLUSIONS Kinesiotaping in addition to exercises is more effective than sham taping and exercises only in improving pain in daily activities and arm disability due to lateral epicondylitis. LEVEL OF EVIDENCE I.",2019,"RESULTS PRTEE total scores at posttreatment and at 4 weeks after treatment were statistically significantly lower in kinesiotaping plus exercises group compared to sham taping plus exercises group and exercises only group.","['Thirty patients with lateral epicondylitis for less than 12\u2009weeks', 'Lateral Epicondylitis Treatment', 'Tertiary medical center, university hospital']","['home exercise program including strengthening and stretching exercises', 'kinesiotaping plus exercises (n\u2009=\u200910), sham taping plus exercises (n\u2009=\u200910), and control (exercises only', 'Kinesiotaping, Sham Taping or Exercises', 'kinesiotaping, sham taping, or exercises']","['QuickDASH score and VAS', 'patient-rated tennis elbow evaluation (PRTEE', 'VAS and grip strength', 'Pain visual analogue scale (VAS), grip strength, and the disabilities of the arm, shoulder and hand', 'grip strength, decrease in VAS at rest and VAS at daily activity', 'QuickDASH) scales', 'pain in daily activities and arm disability']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0039516', 'cui_str': 'Lateral Epicondylitis'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205372', 'cui_str': 'Tertiary (qualifier value)'}, {'cui': 'C0565990', 'cui_str': 'Medical center (environment)'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}]","[{'cui': 'C0475647', 'cui_str': 'Home exercise program (regime/therapy)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0600080', 'cui_str': 'Stretching procedure (procedure)'}, {'cui': 'C4505491', 'cui_str': 'Kinesiotape'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C1704747', 'cui_str': 'Tape (basic dose form)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0039516', 'cui_str': 'Lateral Epicondylitis'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0429271', 'cui_str': 'Grip strength (observable entity)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0037004', 'cui_str': 'Shoulder'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0443144', 'cui_str': 'At rest (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0222045'}]",30.0,0.148749,"RESULTS PRTEE total scores at posttreatment and at 4 weeks after treatment were statistically significantly lower in kinesiotaping plus exercises group compared to sham taping plus exercises group and exercises only group.","[{'ForeName': 'Esra', 'Initials': 'E', 'LastName': 'Giray', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Marmara University School of Medicine, Istanbul, Turkey.'}, {'ForeName': 'Duygu', 'Initials': 'D', 'LastName': 'Karali-Bingul', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Marmara University School of Medicine, Istanbul, Turkey.'}, {'ForeName': 'Gulseren', 'Initials': 'G', 'LastName': 'Akyuz', 'Affiliation': 'Department of Physical Medicine and Rehabilitation and Division of Pain Medicine, Marmara University School of Medicine, Istanbul, Turkey.'}]","PM & R : the journal of injury, function, and rehabilitation",['10.1002/pmrj.12067'] 1220,29506072,Training reproductive health providers to talk about intimate partner violence and reproductive coercion: an exploratory study.,"To explore the effect of provider communication-skills training on frequency of intimate partner violence (IPV) and reproductive coercion (RC) assessment, four family planning clinics were randomized to IPV/RC communication-skills building workshop or standard knowledge-based IPV/RC training and compared to historical controls from the same clinics (before any training). Female patients aged 16-29 completed after-visit surveys. Primary outcomes included provider discussion about IPV/RC, receipt of safety card with IPV/RC resources and patient disclosure of IPV/RC. Chi-square tests were used to compare groups that received training and historical controls. Participants (training: n = 103; historical control: n = 576) were predominantly white with mean age of 22. More patients reported discussion about healthy relationships in both training groups (78-90%) compared to historical controls (49-52%, P < 0.001 for both). Discussion on birth control sabotage and pregnancy coercion was infrequent with patient-participants in both groups (6-17 and 4-13%, respectively). More patients in the clinics that received training reported receiving a safety card (72-84%) as compared to historical controls (9%, P < 0.001 for both). Overall, in this exploratory study, both communication-skills and standard training improved frequency of IPV communication when compared to historical controls but with few differences when compared to each other.",2018,"More patients in the clinics that received training reported receiving a safety card (72-84%) as compared to historical controls (9%, P < 0.001 for both).","['Female patients aged 16-29 completed after-visit surveys', 'Participants (training: n = 103; historical control: n = 576) were predominantly white with mean age of 22', 'four family planning clinics']","['IPV/RC communication-skills building workshop or standard knowledge-based IPV/RC training', 'provider communication-skills training']","['birth control sabotage and pregnancy coercion', 'frequency of IPV communication', 'provider discussion about IPV/RC, receipt of safety card with IPV/RC resources and patient disclosure of IPV/RC', 'frequency of intimate partner violence (IPV) and reproductive coercion (RC) assessment']","[{'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C4517526', 'cui_str': 'One hundred and three'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C3840184', 'cui_str': 'Family planning clinic'}]","[{'cui': 'C0276240', 'cui_str': 'Infectious pustular vulvovaginitis (disorder)'}, {'cui': 'C0870313', 'cui_str': 'Communication skills'}, {'cui': 'C0242262', 'cui_str': 'Workshops'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0022752', 'cui_str': 'Knowledge Bases'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0588407', 'cui_str': 'Communication skills training (procedure)'}]","[{'cui': 'C0700589', 'cui_str': 'Fertility Control'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0009236', 'cui_str': 'Coercion'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0276240', 'cui_str': 'Infectious pustular vulvovaginitis (disorder)'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0557061', 'cui_str': 'Discussion (procedure)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0012625', 'cui_str': 'Information Disclosure'}, {'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]",576.0,0.0198761,"More patients in the clinics that received training reported receiving a safety card (72-84%) as compared to historical controls (9%, P < 0.001 for both).","[{'ForeName': 'H', 'Initials': 'H', 'LastName': 'Zachor', 'Affiliation': 'University of Pittsburgh School of Medicine, 3550 Terrace St, Pittsburgh, PA 15213, USA.'}, {'ForeName': 'J C', 'Initials': 'JC', 'LastName': 'Chang', 'Affiliation': ""Department of Obstetrics, Gynecology, and Reproductive Sciences and the Magee-Women's Research Institute, Department of Medicine, University of Pittsburgh, 3380 Boulevard of the Allies, suite 309, Pittsburgh, PA 15213, USA.""}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Zelazny', 'Affiliation': ""Division of Adolescent and Young Adult Medicine, Department of Pediatrics, Children's Hospital of Pittsburgh, University of Pittsburgh Medical Center, 3420 Fifth Ave., Pittsburgh, PA 15213, USA.""}, {'ForeName': 'K A', 'Initials': 'KA', 'LastName': 'Jones', 'Affiliation': ""Division of Adolescent and Young Adult Medicine, Department of Pediatrics, Children's Hospital of Pittsburgh, University of Pittsburgh Medical Center, 3420 Fifth Ave., Pittsburgh, PA 15213, USA.""}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Miller', 'Affiliation': ""Division of Adolescent and Young Adult Medicine, Department of Pediatrics, Children's Hospital of Pittsburgh, University of Pittsburgh Medical Center, 3420 Fifth Ave., Pittsburgh, PA 15213, USA.""}]",Health education research,['10.1093/her/cyy007'] 1221,30365198,Randomized Controlled Clinical Study to Determine the Oral and Dermal Tolerability of an Experimental Denture Wipe.,"PURPOSE To evaluate oral and dermal tolerance following use and user acceptability of an experimental denture-cleansing wipe. An exploratory objective was to develop a method to assess denture wipe effectiveness in removing debris from denture surfaces. MATERIALS AND METHODS This was a single-center, randomized, controlled, parallel-group, examiner-blind study in participants with ≥1 full/partial denture. Participants were randomized to clean their dentures with the denture wipe (n = 76) or water (n = 76) up to 4 times per day for 14 days. Tolerability was assessed by treatment-emergent adverse events (TEAEs), oral soft tissue examination, and lead hand dermatological assessment. Acceptability was assessed by questionnaire. The feasibility of a methodology to assess the efficacy of the wipe at removing food particles was also evaluated through determination of the mass of chewed peanut particles that the wipe removed after a single use (n = 31). RESULTS The proportion of participants experiencing oral TEAEs by day 14 was 0.039% with the denture wipe (lip injury [n = 1], mouth injury [n = 2]) and 0.013% with the water rinse (coated tongue [n = 1]). There were no dermal TEAEs and no TEAE-related study withdrawals. Skin irritation scores with the denture wipe remained unchanged from baseline. Comparing before vs. after cleaning with the denture wipe, a higher proportion of participants rated their dentures as feeling extremely/very fresh (28.9% pre-/85.5% post-cleaning), feeling extremely/very clean (34.2%/86.8%) and looking extremely/very clean (43.5%/85.5%). More denture-wipe group participants than water-rinse group participants were extremely/very satisfied with the amount of debris removed from their dentures (88.1% vs 72.4%). The methodology used to assess the weight of peanut particles captured from the wipes/dentures appeared to be a feasible investigation technique. CONCLUSIONS The denture wipe was generally well-tolerated and had good user acceptability. The methodology for assessing the mass of peanut particles removed by denture wipes was successful.",2019,"The proportion of participants experiencing oral TEAEs by day 14 was 0.039% with the denture wipe (lip injury [n = 1], mouth injury [n = 2]) and 0.013% with the water rinse (coated tongue [n = 1]).",['participants with ≥1 full/partial denture'],[],"['Skin irritation scores', 'treatment-emergent adverse events (TEAEs), oral soft tissue examination, and lead hand dermatological assessment', 'Tolerability', 'Acceptability']","[{'cui': 'C0011460', 'cui_str': 'Dental Bridgework'}]",[],"[{'cui': 'C0152030', 'cui_str': 'Skin irritation (disorder)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0447424', 'cui_str': 'Oral soft tissues'}, {'cui': 'C1273867', 'cui_str': 'Examination (heading)'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0011625', 'cui_str': 'Agent, Dermatological'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}]",,0.0738024,"The proportion of participants experiencing oral TEAEs by day 14 was 0.039% with the denture wipe (lip injury [n = 1], mouth injury [n = 2]) and 0.013% with the water rinse (coated tongue [n = 1]).","[{'ForeName': 'Alyson', 'Initials': 'A', 'LastName': 'Axe', 'Affiliation': 'GSK Consumer Healthcare, Weybridge, Surrey, UK.'}, {'ForeName': 'Gary R', 'Initials': 'GR', 'LastName': 'Burnett', 'Affiliation': 'GSK Consumer Healthcare, Weybridge, Surrey, UK.'}, {'ForeName': 'Kimberly R', 'Initials': 'KR', 'LastName': 'Milleman', 'Affiliation': 'Salus Research Inc., Fort Wayne, IN.'}, {'ForeName': 'Avinash', 'Initials': 'A', 'LastName': 'Patil', 'Affiliation': 'Syneos Health, Pune, India.'}, {'ForeName': 'Jeffery L', 'Initials': 'JL', 'LastName': 'Milleman', 'Affiliation': 'Salus Research Inc., Fort Wayne, IN.'}]",Journal of prosthodontics : official journal of the American College of Prosthodontists,['10.1111/jopr.12992'] 1222,31595955,Growth During Infancy and Early Childhood and Its Association With Metabolic Risk Biomarkers at 11.5 Years of Age.,"The evidence that fetal life and early infancy are ""critical"" or ""sensitive"" ages for later development of cardiometabolic disease is based on flawed methods for comparing different age periods. Moreover, most previous studies have limited their focus to weight gain, rather than growth in length/height or body mass index (weight (kg)/height (m)2). We undertook a secondary analysis of data from the Promotion of Breastfeeding Intervention Trial (1996-2010), a birth cohort study nested within a large cluster-randomized trial in the Republic of Belarus, that had repeated measurements of weight and length/height taken from birth to 11.5 years of age. We used mixed-effects linear models to analyze associations of changes in standardized weight, length/height, and body mass index during 5 age periods (conception to birth, birth to age 3 months, ages 3-12 months, ages 12 months-6.5 years, and ages 6.5-11.5 years) with fasting glucose, insulin, insulin resistance, β-cell function, and adiponectin at age 11.5 years. We observed strong associations between the metabolic markers and all 3 growth measures, with the largest magnitudes being observed during the latest age period (ages 6.5-11.5 years) and negligible associations during gestation and the first year of life. Later age periods appear more ""sensitive"" than earlier periods to the adverse metabolic association with rapid growth in childhood.",2020,"We observed strong associations between the metabolic markers and all three growth measures, with the largest magnitudes observed during the latest age period (6.5 to 11.5 years) and negligible associations during gestation and the first year of life.","['PROBIT (1996-2010), a birth cohort study nested within a large cluster-randomized trial in the Republic of Belarus, with repeated measures of weight and length/height from birth to 11.5 years of age', 'at age 11.5 years']",[],"['standardized weight, length/height, and BMI', 'fasting glucose, insulin, insulin resistance, β-cell function, and adiponectin']","[{'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C2930714', 'cui_str': 'Republic of Belarus'}, {'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C4517534', 'cui_str': '11.5 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]",[],"[{'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}]",,0.020093,"We observed strong associations between the metabolic markers and all three growth measures, with the largest magnitudes observed during the latest age period (6.5 to 11.5 years) and negligible associations during gestation and the first year of life.","[{'ForeName': 'Xun', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Department of Obstetrics and Gynecology, School of Medicine, National University of Singapore, Singapore.'}, {'ForeName': 'Richard M', 'Initials': 'RM', 'LastName': 'Martin', 'Affiliation': 'Division of Chronic Disease Research Across the Lifecourse, Harvard Medical School and Harvard Pilgrim Health Care Institute, Boston, Massachusetts.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Oken', 'Affiliation': 'NIHR Bristol Biomedical Research Centre, Bristol, United Kingdom.'}, {'ForeName': 'Izzuddin M', 'Initials': 'IM', 'LastName': 'Aris', 'Affiliation': 'Department of Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, United Kingdom.'}, {'ForeName': 'Seungmi', 'Initials': 'S', 'LastName': 'Yang', 'Affiliation': 'Department of Epidemiology, Biostatistics and Occupational Health, Faculty of Medicine, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Kramer', 'Affiliation': 'Author affiliations: Department of Pediatrics, Faculty of Medicine, McGill University, Montreal, Quebec, Canada.'}]",American journal of epidemiology,['10.1093/aje/kwz234'] 1223,30585104,Impact of Timing Between Insulin Administration and Meal Consumption on Glycemic Fluctuation and Outcomes in Hospitalized Patients With Type 2 Diabetes.,"BACKGROUND The effect of time interval from insulin injection to meal consumption (""insulin-meal"") on glycemic fluctuation and outcomes is not well understood. OBJECTIVE This study aims to investigate the impact of coordinated versus mismatched insulin-meal administration on glycemic fluctuation and outcomes among hospitalized patients with type 2 diabetes (T2D). METHODS Hospitalized patients with T2D who received at least 1 dose of insulin as part of sliding scale regimen were included. Data such as capillary blood glucose values and insulin-meal time intervals were collected. RESULTS A total of 215 patients with 840 insulin-meal encounters were eligible for the study. Compared to the insulin-meal mismatch group (n = 206), the coordinated insulin-meal administration group (n = 9) had lower mean glycemic fluctuation (6.5 [2.6] mmol/L vs 5.6 [2.5] mmol/L or 117 [47] mg/dL vs 100 [45] mg/dL). Encounters with the insulin-meal time interval of 30 to 45 minutes (n = 172) were associated with the lowest percentage of severe hyperglycemia occurrences (13%) as compared to encounters with time interval of 0 to 29 minutes (n = 280, 15%) and more than 45 minutes (n = 246, 16%). CONCLUSION Coordinated insulin-meal administration was associated with lower glycemic fluctuation among hospitalized patients with T2D.",2020,"Encounters with the insulin-meal time interval of 30 to 45 minutes (n = 172) were associated with the lowest percentage of severe hyperglycemia occurrences (13%) as compared to encounters with time interval of 0 to 29 minutes (n = 280, 15%) and more than 45 minutes (n = 246, 16%). ","['hospitalized patients with type 2 diabetes (T2D', '\n\n\nHospitalized patients with T2D who received at least 1 dose of insulin as part of sliding scale regimen were included', 'hospitalized patients with T2D', 'Hospitalized Patients With Type 2 Diabetes', '215 patients with 840 insulin-meal encounters were eligible for the study']","['mismatched insulin-meal administration', 'insulin injection to meal consumption (""insulin-meal', 'Insulin Administration and Meal Consumption', 'Coordinated insulin-meal administration']","['capillary blood glucose values and insulin-meal time intervals', 'severe hyperglycemia occurrences', 'Glycemic Fluctuation and Outcomes', 'mean glycemic fluctuation', 'glycemic fluctuation']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C1292711', 'cui_str': 'Part of (attribute)'}, {'cui': 'C0332246', 'cui_str': 'Sliding (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C4709308', 'cui_str': '215 (qualifier value)'}, {'cui': 'C4708913', 'cui_str': '840'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C4553624', 'cui_str': 'With meals (qualifier value)'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0586328', 'cui_str': 'Insulin injection'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]","[{'cui': 'C0229666', 'cui_str': 'Capillary blood (substance)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0587119', 'cui_str': 'Meal Times'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0231239', 'cui_str': 'Fluctuation'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",215.0,0.036994,"Encounters with the insulin-meal time interval of 30 to 45 minutes (n = 172) were associated with the lowest percentage of severe hyperglycemia occurrences (13%) as compared to encounters with time interval of 0 to 29 minutes (n = 280, 15%) and more than 45 minutes (n = 246, 16%). ","[{'ForeName': 'Shu Fang', 'Initials': 'SF', 'LastName': 'Lim', 'Affiliation': 'Department of Pharmacy, Tan Tock Seng Hospital, Singapore, Singapore.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Jong', 'Affiliation': 'Department of Endocrinology, Tan Tock Seng Hospital, Singapore, Singapore.'}, {'ForeName': 'Daniel Ek Kwang', 'Initials': 'DEK', 'LastName': 'Chew', 'Affiliation': 'Department of Endocrinology, Tan Tock Seng Hospital, Singapore, Singapore.'}, {'ForeName': 'Joyce Yu-Chia', 'Initials': 'JY', 'LastName': 'Lee', 'Affiliation': 'Department of Pharmacy, Tan Tock Seng Hospital, Singapore, Singapore.'}]",Journal of pharmacy practice,['10.1177/0897190018818908'] 1224,30291012,Effects of Intensive Blood Pressure Lowering on Kidney Tubule Injury in CKD: A Longitudinal Subgroup Analysis in SPRINT.,"BACKGROUND Random assignment to the intensive systolic blood pressure (SBP) arm (<120mmHg) in the Systolic Blood Pressure Intervention Trial (SPRINT) resulted in more rapid declines in estimated glomerular filtration rates (eGFRs) than in the standard arm (SBP<140mmHg). Whether this change reflects hemodynamic effects or accelerated intrinsic kidney damage is unknown. STUDY DESIGN Longitudinal subgroup analysis of clinical trial participants. SETTINGS & PARTICIPANTS Random sample of SPRINT participants with prevalent chronic kidney disease (CKD) defined as eGFR<60mL/min/1.73m 2 by the CKD-EPI (CKD Epidemiology Collaboration) creatinine-cystatin C equation at baseline. OUTCOMES & MEASUREMENTS Urine biomarkers of tubule function (β 2 -microglobulin [B2M], α 1 -microglobulin [A1M]), and uromodulin), injury (interleukin 18, kidney injury molecule 1, and neutrophil gelatinase-associated lipocalin), inflammation (monocyte chemoattractant protein 1), and repair (human cartilage glycoprotein 40) at baseline, year 1, and year 4. Biomarkers were indexed to urine creatinine concentration and changes between arms were evaluated using mixed-effects linear models and an intention-to-treat approach. RESULTS 978 SPRINT participants (519 in the intensive and 459 in the standard arm) with prevalent CKD were included. Mean age was 72±9 years and eGFR was 46.1±9.4mL/min/1.73m 2 at baseline. Clinical characteristics, eGFR, urinary albumin-creatinine ratio, and all 8 biomarker values were similar across arms at baseline. Compared to the standard arm, eGFR was lower by 2.9 and 3.3mL/min/1.73m 2 in the intensive arm at year 1 and year 4. None of the 8 tubule marker levels was higher in the intensive arm compared to the standard arm at year 1 or year 4. Two tubule function markers (B2M and A1M) were 29% (95% CI, 10%-43%) and 24% (95% CI, 10%-36%) lower at year 1 in the intensive versus standard arm, respectively. LIMITATIONS Exclusion of persons with diabetes, and few participants had advanced CKD. CONCLUSIONS Among participants with CKD in SPRINT, random assignment to the intensive SBP arm did not increase any levels of 8 urine biomarkers of tubule cell damage despite loss of eGFR. These findings support the hypothesis that eGFR declines in the intensive arm of SPRINT predominantly reflect hemodynamic changes rather than intrinsic damage to kidney tubule cells.",2019,None of the 8 tubule marker levels was higher in the intensive arm compared to the standard arm at year 1 or year 4.,"['Random sample of SPRINT participants with prevalent chronic kidney disease (CKD) defined as eGFR<60mL/min/1.73m 2 by the CKD-EPI (CKD Epidemiology Collaboration) creatinine-cystatin C equation at baseline', 'Kidney Tubule Injury in CKD', 'persons with diabetes, and few participants had advanced CKD', '978 SPRINT participants (519 in the intensive and 459 in the standard arm) with prevalent CKD were included', 'Longitudinal subgroup analysis of clinical trial participants']",['Intensive Blood Pressure Lowering'],"['tubule function markers (B2M and A1M', 'Clinical characteristics, eGFR, urinary albumin-creatinine ratio, and all 8 biomarker values', 'Urine biomarkers of tubule function (β 2 -microglobulin [B2M', 'eGFR', 'levels of 8 urine biomarkers of tubule cell damage despite loss of eGFR', 'uromodulin), injury (interleukin 18, kidney injury molecule 1, and neutrophil gelatinase-associated lipocalin), inflammation (monocyte chemoattractant protein 1), and repair (human cartilage glycoprotein 40', 'intensive systolic blood pressure (SBP']","[{'cui': 'C0439605', 'cui_str': 'Random (qualifier value)'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C1561643', 'cui_str': 'Chronic Kidney Diseases'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0267963', 'cui_str': 'Pancreatic Insufficiency'}, {'cui': 'C0014507', 'cui_str': 'Epidemiology'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0071744', 'cui_str': 'Cystatin 3'}, {'cui': 'C0022674', 'cui_str': 'Kidney Tubules'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C1997894', 'cui_str': 'Clinical trial participant'}]","[{'cui': 'C0005823', 'cui_str': 'Blood Pressure'}]","[{'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C3711292', 'cui_str': '68Ga-albumin'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0042037'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0010957', 'cui_str': 'Damage (morphologic abnormality)'}, {'cui': 'C0077918', 'cui_str': 'Uromucoid'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0383327', 'cui_str': 'Interferon-gamma-Inducing Factor'}, {'cui': 'C2681921', 'cui_str': 'Kidney injury molecule-1'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear Leukocytes'}, {'cui': 'C0206528', 'cui_str': 'Gelatinases'}, {'cui': 'C1956074', 'cui_str': 'Lipocalins'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0128897', 'cui_str': 'Chemokine (C-C Motif) Ligand 2'}, {'cui': 'C0374711', 'cui_str': 'Surgical repair (procedure)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0007301', 'cui_str': 'Cartilage'}, {'cui': 'C0017968', 'cui_str': 'Glycoproteins'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0911267', 'cui_str': 'SBP protein, Papaver rhoeas'}]",978.0,0.262057,None of the 8 tubule marker levels was higher in the intensive arm compared to the standard arm at year 1 or year 4.,"[{'ForeName': 'Rakesh', 'Initials': 'R', 'LastName': 'Malhotra', 'Affiliation': 'Division of Nephrology and Hypertension, Department of Medicine, University of California San Diego, San Diego, CA; Imperial Valley Family Care Medical Group, El Centro, CA.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Craven', 'Affiliation': 'Department of Biostatistical Sciences, Wake Forest School of Medicine, Winston-Salem, NC.'}, {'ForeName': 'Walter T', 'Initials': 'WT', 'LastName': 'Ambrosius', 'Affiliation': 'Department of Biostatistical Sciences, Wake Forest School of Medicine, Winston-Salem, NC.'}, {'ForeName': 'Anthony A', 'Initials': 'AA', 'LastName': 'Killeen', 'Affiliation': 'Department of Laboratory Medicine and Pathology, University of Minnesota, Minneapolis, MN.'}, {'ForeName': 'William E', 'Initials': 'WE', 'LastName': 'Haley', 'Affiliation': 'Division of Nephrology, Department of Medicine, Mayo Clinic, Jacksonville, FL.'}, {'ForeName': 'Alfred K', 'Initials': 'AK', 'LastName': 'Cheung', 'Affiliation': 'Division of Nephrology & Hypertension, Department of Internal Medicine, University of Utah; Medical Service, Veterans Affairs Salt Lake City Healthcare System, Salt Lake City, UT.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Chonchol', 'Affiliation': 'Division of Nephrology & Hypertension, Department of Medicine, University of Colorado, Denver, CO.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Sarnak', 'Affiliation': 'Division of Nephrology, Department of Medicine, Tufts Medical Center, Boston, MA.'}, {'ForeName': 'Chirag R', 'Initials': 'CR', 'LastName': 'Parikh', 'Affiliation': 'Division of Nephrology, Department of Medicine, Yale University School of Medicine, New Haven, CT.'}, {'ForeName': 'Michael G', 'Initials': 'MG', 'LastName': 'Shlipak', 'Affiliation': 'Division of General Internal Medicine, San Francisco VA Medical Center, San Francisco, CA; Kidney Health Research Collaborative, San Francisco VA Medical Center and University of California, San Francisco, CA.'}, {'ForeName': 'Joachim H', 'Initials': 'JH', 'LastName': 'Ix', 'Affiliation': 'Division of Nephrology and Hypertension, Department of Medicine, University of California San Diego, San Diego, CA; Division of Preventive Medicine, Department of Family Medicine and Public Health, University of California San Diego, San Diego, CA; Nephrology Section, Veterans Affairs San Diego Healthcare System, La Jolla, CA. Electronic address: joeix@ucsd.edu.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American journal of kidney diseases : the official journal of the National Kidney Foundation,['10.1053/j.ajkd.2018.07.015'] 1225,31613703,Enhancing Connections-Palliative Care: A Quasi-Experimental Pilot Feasibility Study of a Cancer Parenting Program.,"Background: In 2018, >75,000 children were newly affected by the diagnosis of advanced cancer in a parent. Unfortunately, few programs exist to help parents and their children manage the impact of advanced disease together as a family. The Enhancing Connections-Palliative Care (EC-PC) parenting program was developed in response to this gap. Objective: (1) Assess the feasibility of the EC-PC parenting program (recruitment, enrollment, and retention); (2) test the short-term impact of the program on changes in parent and child outcomes; and (3) explore the relationship between parents' physical and psychological symptoms with program outcomes. Design: Quasi-experimental two-group design employing both within- and between-subjects analyses to examine change over time and change relative to historical controls. Parents participated in five telephone-delivered and fully manualized behavioral intervention sessions at two-week intervals, delivered by trained nurses. Behavioral assessments were obtained at baseline and at three months on parents' depressed mood, anxiety, parenting skills, parenting self-efficacy, and symptom distress as well as children's behavioral-emotional adjustment (internalizing, externalizing, and anxiety/depression). Subjects: Parents diagnosed with advanced or metastatic cancer and receiving noncurative treatment were eligible for the trial provided they had one or more children aged 5-17 living at home, were able to read, write, and speak English, and were not enrolled in a hospice program. Results: Of those enrolled, 62% completed all intervention sessions and post-intervention assessments. Within-group analyses showed significant improvements in parents' self-efficacy in helping their children manage pressures from the parent's cancer; parents' skills to elicit children's cancer-related concerns; and parents' skills to help their children cope with the cancer. Between-group analyses revealed comparable improvements with historical controls on parents' anxiety, depressed mood, self-efficacy, parenting skills, and children's behavioral-emotional adjustment. Conclusion: The EC-PC parenting program shows promise in significantly improving parents' skills and confidence in supporting their child about the cancer. Further testing of the program is warranted.",2020,"Between-group analyses revealed comparable improvements with historical controls on parents' anxiety, depressed mood, self-efficacy, parenting skills, and children's behavioral-emotional adjustment. ","['Subjects: Parents diagnosed with advanced or metastatic cancer and receiving noncurative treatment were eligible for the trial provided they had one or more children aged 5-17 living at home, were able to read, write, and speak English, and were not enrolled in a hospice program', 'In 2018, >75,000 children were newly affected by the diagnosis of advanced cancer in a parent', 'Enhancing Connections-Palliative Care']","['Cancer Parenting Program', 'EC-PC parenting program', 'telephone-delivered and fully manualized behavioral intervention sessions']","[""parents' self-efficacy"", ""parents' anxiety, depressed mood, self-efficacy, parenting skills, and children's behavioral-emotional adjustment"", ""mood, anxiety, parenting skills, parenting self-efficacy, and symptom distress as well as children's behavioral-emotional adjustment (internalizing, externalizing, and anxiety/depression"", 'Behavioral assessments']","[{'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C2939419', 'cui_str': 'Metastatic cancer'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0586740', 'cui_str': 'Able to read (finding)'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C3540738', 'cui_str': 'English [International Organization for Standardization 639-1 code en] language reference set (foundation metadata concept)'}, {'cui': 'C0086422', 'cui_str': 'Hospice Programs'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}, {'cui': 'C0449379', 'cui_str': 'Connection (attribute)'}, {'cui': 'C0700049', 'cui_str': 'Palliative care'}]","[{'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}]","[{'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0344315', 'cui_str': 'Depressed'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0557904', 'cui_str': 'Psychological Adjustment'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C1160858', 'cui_str': 'Behavior care assessment'}]",17.0,0.0199027,"Between-group analyses revealed comparable improvements with historical controls on parents' anxiety, depressed mood, self-efficacy, parenting skills, and children's behavioral-emotional adjustment. ","[{'ForeName': 'Frances Marcus', 'Initials': 'FM', 'LastName': 'Lewis', 'Affiliation': 'University of Washington, Seattle, Washington.'}, {'ForeName': 'Elizabeth Trice', 'Initials': 'ET', 'LastName': 'Loggers', 'Affiliation': 'Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, Washington.'}, {'ForeName': 'Farya', 'Initials': 'F', 'LastName': 'Phillips', 'Affiliation': 'The University of Texas at Austin, Austin, Texas.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Palacios', 'Affiliation': 'New Mexico State University, Las Cruces, New Mexico.'}, {'ForeName': 'Kenneth P', 'Initials': 'KP', 'LastName': 'Tercyak', 'Affiliation': 'Lombardi Comprehensive Cancer Center, Georgetown University, Washington, DC.'}, {'ForeName': 'Kristin A', 'Initials': 'KA', 'LastName': 'Griffith', 'Affiliation': 'University of Washington, Seattle, Washington.'}, {'ForeName': 'Mary Ellen', 'Initials': 'ME', 'LastName': 'Shands', 'Affiliation': 'University of Washington, Seattle, Washington.'}, {'ForeName': 'Ellen H', 'Initials': 'EH', 'LastName': 'Zahlis', 'Affiliation': 'University of Washington, Seattle, Washington.'}, {'ForeName': 'Zainab', 'Initials': 'Z', 'LastName': 'Alzawad', 'Affiliation': 'University of Washington, Seattle, Washington.'}, {'ForeName': 'Hebah Ahmed', 'Initials': 'HA', 'LastName': 'Almulla', 'Affiliation': 'University of Washington, Seattle, Washington.'}]",Journal of palliative medicine,['10.1089/jpm.2019.0163'] 1226,31654328,Development of In Vitro-In Vivo Correlation for Upadacitinib Extended-Release Tablet Formulation.,"Upadacitinib is a selective Janus Kinase 1 inhibitor which is being developed for the treatment of several inflammatory diseases including rheumatoid arthritis. Upadacitinib was evaluated in Phase 3 studies as an oral extended-release (ER) formulation administered once daily. The purpose of this study was to develop a level A in vitro-in vivo correlation (IVIVC) for upadacitinib ER formulation. The pharmacokinetics of four upadacitinib extended-release formulations with different in vitro release characteristics and an immediate-release capsule formulation of upadacitinib were evaluated in 20 healthy subjects in a single-dose, randomized, crossover study. In vivo pharmacokinetic data and in vitro dissolution data (USP Dissolution Apparatus 1; pH 6.8; 100 rpm) were used to establish a level A IVIVC. Three formulations were used to establish the IVIVC, and the fourth formulation was used for external validation. A non-linear IVIVC best described the relationship between upadacitinib in vitro dissolution and in vivo absorption profiles. The absolute percent prediction errors (%PE) for upadacitinib C max and AUC were less than 10% for all three formulations used to establish the IVIVC, as well as for the %PE for the external validation formulation and the overall mean internal validation. Model was cross-validated using the leave-one-out approach; all evaluated cross-validation runs met the regulatory acceptance criteria. A level A IVIVC was successfully developed and validated for upadacitinib ER formulation, which meets the FDA and EMA regulatory validation criteria and can be used as surrogate for in vivo bioequivalence.",2019,"The absolute percent prediction errors (%PE) for upadacitinib C max and AUC were less than 10% for all three formulations used to establish the IVIVC, as well as for the %PE for the external validation formulation and the overall mean internal validation.",['20 healthy subjects'],[],[],"[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]",[],[],20.0,0.0205415,"The absolute percent prediction errors (%PE) for upadacitinib C max and AUC were less than 10% for all three formulations used to establish the IVIVC, as well as for the %PE for the external validation formulation and the overall mean internal validation.","[{'ForeName': 'Mohamed-Eslam F', 'Initials': 'MF', 'LastName': 'Mohamed', 'Affiliation': 'Clinical Pharmacology and Pharmacometrics, AbbVie Inc., 1 North Waukegan Road, AP31-3, North Chicago, Illinois, 60064, USA. mohamed-eslam.mohamed@abbvie.com.'}, {'ForeName': 'Sheryl', 'Initials': 'S', 'LastName': 'Trueman', 'Affiliation': 'Clinical Pharmacology and Pharmacometrics, AbbVie Inc., 1 North Waukegan Road, AP31-3, North Chicago, Illinois, 60064, USA.'}, {'ForeName': 'Ahmed A', 'Initials': 'AA', 'LastName': 'Othman', 'Affiliation': 'Clinical Pharmacology and Pharmacometrics, AbbVie Inc., 1 North Waukegan Road, AP31-3, North Chicago, Illinois, 60064, USA.'}, {'ForeName': 'Jian-Hwa', 'Initials': 'JH', 'LastName': 'Han', 'Affiliation': 'Dissolution Sciences, AbbVie Inc., North Chicago, Illinois, USA.'}, {'ForeName': 'Tzuchi R', 'Initials': 'TR', 'LastName': 'Ju', 'Affiliation': 'Dissolution Sciences, AbbVie Inc., North Chicago, Illinois, USA.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Marroum', 'Affiliation': 'Clinical Pharmacology and Pharmacometrics, AbbVie Inc., 1 North Waukegan Road, AP31-3, North Chicago, Illinois, 60064, USA.'}]",The AAPS journal,['10.1208/s12248-019-0378-y'] 1227,31664156,Repeated buffered acidic saline infusion in the human masseter muscle as a putative experimental pain model.,"This study investigated if repeated buffered acidic saline infusions into the masseter muscles induced muscle pain and mechanical sensitization. Fourteen healthy men participated in this double-blind, randomized, and placebo-controlled study. Two repeated infusions (day 1 and 3) were given in the masseter muscles with either a buffered acidic saline solution (pH 5.2) or an isotonic saline solution (pH 6) as control. After 10 days of wash-out, the experiment was repeated with the other substance. Pressure pain thresholds (PPT), pain intensity, maximum unassisted mouth opening (MUO), and pain drawings were assessed before, directly following, and after each infusion at 5, 15, and 30 min and on day 4 and 7. Fatigue and pain intensity were assessed after a one-minute chewing test 30 min after infusions and day 4 and 7. Acidic saline induced higher pain intensity than control day 3 up to 5 min after infusions, but did not affect PPT. The chewing test did not evoke higher fatigue during chewing or MUO or after acidic saline infusion compared to control. Repeated acidic saline infusions in the masseter muscles induced a short-lasting muscle pain without mechanical hyperalgesia or functional pain. Hence, this model might not be superior to already existing experimental muscle pain models.",2019,Repeated acidic saline infusions in the masseter muscles induced a short-lasting muscle pain without mechanical hyperalgesia or functional pain.,['Fourteen healthy men'],"['acidic saline infusions', 'buffered acidic saline solution (pH 5.2) or an isotonic saline solution (pH 6) as control', 'placebo', 'acidic saline', 'Acidic saline', 'acidic saline infusion']","['Pressure pain thresholds (PPT), pain intensity, maximum unassisted mouth opening (MUO), and pain drawings', 'muscle pain and mechanical sensitization', 'Fatigue and pain intensity', 'higher pain intensity']","[{'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0006353', 'cui_str': 'Buffers'}, {'cui': 'C4517790', 'cui_str': '5.2 (qualifier value)'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0162703', 'cui_str': 'Pain Threshold'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0230028', 'cui_str': 'Structure of oral region of face'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0013113', 'cui_str': 'Drawing'}, {'cui': 'C0231528', 'cui_str': 'Muscle Pain'}, {'cui': 'C0443254', 'cui_str': 'Mechanical (qualifier value)'}, {'cui': 'C1325847', 'cui_str': 'Sensitization'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]",14.0,0.386685,Repeated acidic saline infusions in the masseter muscles induced a short-lasting muscle pain without mechanical hyperalgesia or functional pain.,"[{'ForeName': 'Sofia', 'Initials': 'S', 'LastName': 'Louca Jounger', 'Affiliation': 'Division of Oral Diagnostics and Rehabilitation, Department of Dental Medicine, Karolinska Institutet, SE-141 04, Huddinge, Sweden. Sofia.Louca@ki.se.'}, {'ForeName': 'Niklas', 'Initials': 'N', 'LastName': 'Eriksson', 'Affiliation': 'Division of Oral Diagnostics and Rehabilitation, Department of Dental Medicine, Karolinska Institutet, SE-141 04, Huddinge, Sweden.'}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Lindskog', 'Affiliation': 'Division of Oral Diagnostics and Rehabilitation, Department of Dental Medicine, Karolinska Institutet, SE-141 04, Huddinge, Sweden.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Oscarsson', 'Affiliation': 'Division of Oral Diagnostics and Rehabilitation, Department of Dental Medicine, Karolinska Institutet, SE-141 04, Huddinge, Sweden.'}, {'ForeName': 'Vivian', 'Initials': 'V', 'LastName': 'Simonsson', 'Affiliation': 'Division of Oral Diagnostics and Rehabilitation, Department of Dental Medicine, Karolinska Institutet, SE-141 04, Huddinge, Sweden.'}, {'ForeName': 'Malin', 'Initials': 'M', 'LastName': 'Ernberg', 'Affiliation': 'Division of Oral Diagnostics and Rehabilitation, Department of Dental Medicine, Karolinska Institutet, SE-141 04, Huddinge, Sweden.'}, {'ForeName': 'Nikolaos', 'Initials': 'N', 'LastName': 'Christidis', 'Affiliation': 'Division of Oral Diagnostics and Rehabilitation, Department of Dental Medicine, Karolinska Institutet, SE-141 04, Huddinge, Sweden.'}]",Scientific reports,['10.1038/s41598-019-51670-3'] 1228,31668850,"Palbociclib plus exemestane with gonadotropin-releasing hormone agonist versus capecitabine in premenopausal women with hormone receptor-positive, HER2-negative metastatic breast cancer (KCSG-BR15-10): a multicentre, open-label, randomised, phase 2 trial.","BACKGROUND Endocrine treatment is recommended by clinical guidelines as the preferred treatment option for premenopausal as well as postmenopausal women with hormone receptor-positive, HER2-negative metastatic breast cancer. In real-world clinical practice, however, a substantial number of patients are treated with chemotherapy. We aimed to compare the clinical antitumour activity and safety of palbociclib plus endocrine therapy with that of capecitabine chemotherapy in premenopausal women with hormone receptor-positive, HER2-negative metastatic breast cancer. METHODS This multicentre, open-label, randomised, phase 2 study was done in 14 academic institutions in South Korea. Premenopausal women aged 19 years or older with hormone receptor-positive, HER2-negative breast cancer that had relapsed or progressed during previous tamoxifen therapy and with an Eastern Cooperative Oncology Group performance status of 0-2 were included. One line of previous chemotherapy for metastatic breast cancer was allowed. Patients were randomly assigned, using a random permuted block design (with a block size of two), to receive palbociclib plus combination endocrine therapy (oral exemestane 25 mg per day for 28 days and oral palbociclib 125 mg per day for 21 days every 4 weeks plus leuprolide 3·75 mg subcutaneously every 4 weeks) or chemotherapy (oral capecitabine 1250 mg/m 2 twice daily for 2 weeks every 3 weeks). Randomisation was stratified by previous chemotherapy for metastatic breast cancer and visceral metastasis. The primary endpoint was progression-free survival. All analyses were done in a modified intention-to-treat population that excluded patients who did not receive study medication. This study is registered with ClinicalTrials.gov, NCT02592746, and is ongoing for follow-up of overall survival. FINDINGS Between June 15, 2016, and Dec 10, 2018, 189 patients were enrolled, of whom 184 were randomly assigned to the palbociclib plus endocrine therapy group (n=92) or the capecitabine group (n=92). Six patients in the capecitabine group withdrew from the study before drug administration; therefore, 92 patients in the palbociclib plus endocrine therapy group and 86 patients in the capecitabine group were included in the modified intention-to-treat analyses. 46 (50%) of 92 patients in the palbociclib plus endocrine therapy group and 45 (51%) of 92 in the capecitabine group were treatment naive for metastatic breast cancer. During a median follow-up of 17 months (IQR 9-22), median progression-free survival was 20·1 months (95% CI 14·2-21·8) in the palbociclib plus endocrine therapy group versus 14·4 months (12·1-17·0) in the capecitabine group (hazard ratio 0·659 [95% CI 0·437-0·994], one-sided log-rank p=0·0235). Treatment-related grade 3 or worse neutropenia was more common in the palbociclib plus endocrine therapy group than in the capecitabine group (69 [75%] of 92 vs 14 [16%] of 86 patients). 2 (2%) patients in the palbociclib plus endocrine therapy group and 15 (17%) patients in the capecitabine group had treatment-related serious adverse events. No treatment-related deaths occurred. INTERPRETATION Exemestane plus palbociclib with ovarian function suppression showed clinical benefit compared with capecitabine in terms of improved progression-free survival in premenopausal patients with hormone receptor-positive, HER2-negative metastatic breast cancer. Palbociclib plus exemestane with ovarian suppression is an active treatment option in premenopausal patients with hormone receptor-positive, HER2-negative metastatic breast cancer who have been pretreated with tamoxifen. FUNDING Pfizer, Shinpoong, and Daewoong Korea and Takeda.",2019,Treatment-related grade 3 or worse neutropenia was more common in the palbociclib plus endocrine therapy group than in the capecitabine group (69 [75%] of 92 vs 14 [16%] of 86 patients).,"['premenopausal women with hormone receptor-positive, HER2-negative metastatic breast cancer (KCSG-BR15-10', 'premenopausal women with hormone receptor-positive, HER2-negative metastatic breast cancer', 'postmenopausal women with hormone receptor-positive, HER2-negative metastatic breast cancer', 'Premenopausal women aged 19 years or older with hormone receptor-positive, HER2-negative breast cancer that had relapsed or progressed during previous tamoxifen therapy and with an Eastern Cooperative Oncology Group performance status of 0-2 were included', 'Six patients in the capecitabine group withdrew from the study before drug administration; therefore, 92 patients in the palbociclib plus endocrine therapy group and 86 patients in the', 'Between June 15, 2016, and Dec 10, 2018, 189 patients were enrolled, of whom 184', 'premenopausal patients with hormone receptor-positive, HER2-negative metastatic breast cancer', '14 academic institutions in South Korea', 'premenopausal patients with hormone receptor-positive, HER2-negative metastatic breast cancer who have been pretreated with']","['palbociclib plus endocrine therapy', 'capecitabine chemotherapy', 'Palbociclib plus exemestane with gonadotropin-releasing hormone agonist versus capecitabine', 'leuprolide', 'chemotherapy (oral capecitabine 1250', 'Palbociclib plus exemestane with ovarian suppression', 'palbociclib plus combination endocrine therapy (oral exemestane', 'capecitabine', 'tamoxifen']","['progression-free survival', 'median progression-free survival', 'treatment-related serious adverse events', 'Treatment-related grade 3 or worse neutropenia']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0019932', 'cui_str': 'Hormones'}, {'cui': 'C0597357', 'cui_str': 'Receptor (substance)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C4087376', 'cui_str': 'HER2 negative'}, {'cui': 'C0278488', 'cui_str': 'Breast cancer metastatic'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C4510392', 'cui_str': 'Tamoxifen therapy'}, {'cui': 'C1520224', 'cui_str': 'Eastern Cooperative Oncology Group performance status'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0424092', 'cui_str': 'Withdrawn (finding)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0150270', 'cui_str': 'Medication administration case management'}, {'cui': 'C3853822', 'cui_str': 'palbociclib'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy (procedure)'}, {'cui': 'C4517616', 'cui_str': 'One hundred and eighty-four'}, {'cui': 'C1272753', 'cui_str': 'Institution'}, {'cui': 'C0022773', 'cui_str': 'South Korea'}]","[{'cui': 'C3853822', 'cui_str': 'palbociclib'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy (procedure)'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0851344', 'cui_str': 'exemestane'}, {'cui': 'C4543260', 'cui_str': 'Gonadotropin'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0019932', 'cui_str': 'Hormones'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0085272', 'cui_str': 'Leuprolide'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C4517554', 'cui_str': 'One thousand two hundred and fifty'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression (disorder)'}, {'cui': 'C0039286', 'cui_str': 'Tamoxifen'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}]",189.0,0.1161,Treatment-related grade 3 or worse neutropenia was more common in the palbociclib plus endocrine therapy group than in the capecitabine group (69 [75%] of 92 vs 14 [16%] of 86 patients).,"[{'ForeName': 'Yeon Hee', 'Initials': 'YH', 'LastName': 'Park', 'Affiliation': 'Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea. Electronic address: yhparkhmo@skku.edu.'}, {'ForeName': 'Tae-Yong', 'Initials': 'TY', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Gun Min', 'Initials': 'GM', 'LastName': 'Kim', 'Affiliation': 'Division of Medical Oncology and Department of Internal Medicine, Yonsei University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Seok Yun', 'Initials': 'SY', 'LastName': 'Kang', 'Affiliation': 'Department of Hematology-Oncology, Ajou University School of Medicine, Suwon, South Korea.'}, {'ForeName': 'In Hae', 'Initials': 'IH', 'LastName': 'Park', 'Affiliation': 'Center for Breast Cancer, National Cancer Center, Goyang, South Korea.'}, {'ForeName': 'Jee Hyun', 'Initials': 'JH', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, South Korea.'}, {'ForeName': 'Kyoung Eun', 'Initials': 'KE', 'LastName': 'Lee', 'Affiliation': 'Department of Hematology and Oncology, Ewha Womans University Hospital, Seoul, South Korea.'}, {'ForeName': 'Hee Kyung', 'Initials': 'HK', 'LastName': 'Ahn', 'Affiliation': 'Division of Medical Oncology and Department of Internal Medicine, Gachon University Gil Medical Center, Incheon, South Korea.'}, {'ForeName': 'Moon Hee', 'Initials': 'MH', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, Inha University School of Medicine, Incheon, South Korea.'}, {'ForeName': 'Hee-Jun', 'Initials': 'HJ', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Chung-Ang University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Han Jo', 'Initials': 'HJ', 'LastName': 'Kim', 'Affiliation': 'Division of Hematology and Oncology, Department of Internal Medicine, Soonchunhyang University Hospital, Cheonan, South Korea.'}, {'ForeName': 'Jong In', 'Initials': 'JI', 'LastName': 'Lee', 'Affiliation': 'Division of Hematology-Oncology, Department of Internal Medicine, Wonju Severance Christian Hospital, Yonsei University Wonju College of Medicine, Wonju, South Korea.'}, {'ForeName': 'Su-Jin', 'Initials': 'SJ', 'LastName': 'Koh', 'Affiliation': 'Department of Hematology and Oncology, Ulsan University Hospital, Ulsan University College of Medicine, Ulsan, South Korea.'}, {'ForeName': 'Ji-Yeon', 'Initials': 'JY', 'LastName': 'Kim', 'Affiliation': 'Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea.'}, {'ForeName': 'Kyung-Hun', 'Initials': 'KH', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Joohyuk', 'Initials': 'J', 'LastName': 'Sohn', 'Affiliation': 'Division of Medical Oncology and Department of Internal Medicine, Yonsei University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Sung-Bae', 'Initials': 'SB', 'LastName': 'Kim', 'Affiliation': 'Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Jin-Seok', 'Initials': 'JS', 'LastName': 'Ahn', 'Affiliation': 'Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea.'}, {'ForeName': 'Young-Hyuck', 'Initials': 'YH', 'LastName': 'Im', 'Affiliation': 'Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea.'}, {'ForeName': 'Kyung Hae', 'Initials': 'KH', 'LastName': 'Jung', 'Affiliation': 'Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Seock-Ah', 'Initials': 'SA', 'LastName': 'Im', 'Affiliation': 'Department of Internal Medicine, Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine, Seoul, South Korea.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Oncology,['10.1016/S1470-2045(19)30565-0'] 1229,30557093,Well on wheels intervention: Satisfaction with life and health for adults with spinal cord injuries.,"Objective/Background: To examine how demographic and injury characteristics identify satisfaction with life (SWL), and assess the differential effects of a wellness intervention by baseline SWL groups. Design: Baseline and longitudinal analysis of a randomized controlled pilot intervention using decision tree regression and linear mixed models. Setting: Community based. Participants: Seventy-two individuals with spinal cord injury (SCI) were randomized to an intervention group ( n  = 39) or control group ( n  = 33). Participants were aged 44.1 ± 13.0 years and 13.1 ± 10.6 years post-injury. Most participants were male ( n  = 50; 69.4%) and had paraplegia ( n  = 38; 52.7%). Participants were classified as high versus low SWL at baseline using a cutoff score of 20. Interventions: The intervention aimed to increase self-efficacy, and in turn, increase engagement in health-promoting behaviors related to SWL. Six 4-hour in-person workshops were conducted over a 3-month period led by experts and peer-mentors who were available for support. Outcome measure(s): Self-efficacy for health practices, secondary condition severity, health-promoting behaviors, perceived stress, and SWL. Results: At baseline, participants with low SWL were recently injured (<4.5 years), while persons with high SWL were married and younger (<49 years old). Intervention participants with low SWL at baseline significantly improved SWL over time compared to those with high SWL ( P  = 0.02). Conclusion: Certain injury and demographic characteristics were associated with SWL, and intervention participants with low SWL at baseline improved their SWL over 2 years. Healthcare providers should consider time post-injury, marital status, and age in identifying individuals at risk for low SWL that may benefit from wellness interventions.",2020,"Intervention participants with low SWL at baseline significantly improved SWL over time compared to those with high SWL (P = 0.02). ","['Seventy-two individuals with spinal cord injury (SCI', 'Participants were aged 44.1\u2009±\u200913.0 years and 13.1\u2009±\u200910.6 years post-injury', 'participants with low SWL were recently injured (<4.5 years), while persons with high SWL were married and younger (<49 years old', 'Community based', 'adults with spinal cord injuries', 'Most participants were male (n\u2009=\u200950; 69.4%) and had paraplegia (n\u2009=\u200938; 52.7']",[],"['Self-efficacy for health practices, secondary condition severity, health-promoting behaviors, perceived stress, and SWL', 'SWL over time', 'self-efficacy']","[{'cui': 'C4319632', 'cui_str': 'Seventy-two'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0037929', 'cui_str': 'Spinal Cord Trauma'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C3844009', 'cui_str': 'Four point five'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0555047', 'cui_str': 'Married (finding)'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0030486', 'cui_str': 'Paralysis, Legs'}]",[],"[{'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C1292730', 'cui_str': 'Condition severity'}, {'cui': 'C0517496', 'cui_str': 'Health promotion behavior'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",72.0,0.102242,"Intervention participants with low SWL at baseline significantly improved SWL over time compared to those with high SWL (P = 0.02). ","[{'ForeName': 'Stephanie L', 'Initials': 'SL', 'LastName': 'Silveira', 'Affiliation': 'Department of Health and Human Performance, University of Houston, Houston, Texas, USA.'}, {'ForeName': 'Tracey A', 'Initials': 'TA', 'LastName': 'Ledoux', 'Affiliation': 'Department of Health and Human Performance, University of Houston, Houston, Texas, USA.'}, {'ForeName': 'Craig A', 'Initials': 'CA', 'LastName': 'Johnston', 'Affiliation': 'Department of Health and Human Performance, University of Houston, Houston, Texas, USA.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Kalpakjian', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, University of Michigan, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Daniel P', 'Initials': 'DP', 'LastName': ""O'Connor"", 'Affiliation': 'Department of Health and Human Performance, University of Houston, Houston, Texas, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Cottingham', 'Affiliation': 'Department of Health and Human Performance, University of Houston, Houston, Texas, USA.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'McGrath', 'Affiliation': 'Department of Health, Nutrition, and Exercise Sciences, North Dakota State University, Fargo, North Dakota, USA.'}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Tate', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, University of Michigan, Ann Arbor, Michigan, USA.'}]",The journal of spinal cord medicine,['10.1080/10790268.2018.1554333'] 1230,30278777,Effect of Exercise on Behavioral Symptoms and Pain in Patients With Dementia Living in Nursing Homes.,"OBJECTIVES Examine the effects of a 6-month exercise intervention on neuropsychiatric symptoms, pain, and medication consumption in older people with dementia (PWD) living in nursing homes (NH). METHODS Ninety-one older PWD living in NH performed a 6-month structured exercise intervention (n = 44) or a social activity intervention (n = 47). Neuropsychiatric symptoms were measured by the neuropsychiatric inventory (NPI), pain was assessed using the Algoplus scale, and dementia-related drug prescriptions were obtained for all participants. RESULTS Between-group analysis found a nonsignificant difference that could be of clinical relevance: a 4-point difference in the NPI and 1.3-point difference in the reduction of the number of medications favoring exercisers. No significant differences were found for pain, and a trend was found for an increase in medication consumption in the social group. CONCLUSION Exercise effects did not differ from social intervention effects on neuropsychiatric symptoms, pain, and medication consumption in older PWD living in NH.",2019,"No significant differences were found for pain, and a trend was found for an increase in medication consumption in the social group. ","['older people with dementia (PWD) living in nursing homes (NH', 'Ninety-one older PWD living in NH performed a 6-month', 'older PWD living in NH', 'Patients With Dementia Living in Nursing Homes']","['structured exercise intervention', 'Exercise', 'exercise intervention', 'social activity intervention']","['neuropsychiatric symptoms, pain, and medication consumption', 'Behavioral Symptoms and Pain', 'pain', 'neuropsychiatric inventory (NPI), pain', 'medication consumption', 'Neuropsychiatric symptoms']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0497327', 'cui_str': 'Amentia'}, {'cui': 'C0425205', 'cui_str': 'Lives in a nursing home (finding)'}, {'cui': 'C3816959', 'cui_str': 'Ninety'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}]","[{'cui': 'C4285807', 'cui_str': 'Neuropsychiatric symptoms'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0004941', 'cui_str': 'Behavioral Symptoms'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}]",91.0,0.0687231,"No significant differences were found for pain, and a trend was found for an increase in medication consumption in the social group. ","[{'ForeName': 'Mathieu', 'Initials': 'M', 'LastName': 'Maltais', 'Affiliation': 'Gérontopôle de Toulouse, Institut du Vieillissement, Centre Hospitalo-Universitaire de Toulouse, Toulouse, France.'}, {'ForeName': 'Yves', 'Initials': 'Y', 'LastName': 'Rolland', 'Affiliation': 'Gérontopôle de Toulouse, Institut du Vieillissement, Centre Hospitalo-Universitaire de Toulouse, Toulouse, France.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Vellas', 'Affiliation': 'Gérontopôle de Toulouse, Institut du Vieillissement, Centre Hospitalo-Universitaire de Toulouse, Toulouse, France.'}, {'ForeName': 'Paul-Emile', 'Initials': 'PE', 'LastName': 'Haÿ', 'Affiliation': 'Institut Bien Vieillir Korian, Paris, France.'}, {'ForeName': 'Didier', 'Initials': 'D', 'LastName': 'Armaingaud', 'Affiliation': 'Institut Bien Vieillir Korian, Paris, France.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Cestac', 'Affiliation': 'Gérontopôle de Toulouse, Institut du Vieillissement, Centre Hospitalo-Universitaire de Toulouse, Toulouse, France.'}, {'ForeName': 'Laure', 'Initials': 'L', 'LastName': 'Rouch', 'Affiliation': 'Gérontopôle de Toulouse, Institut du Vieillissement, Centre Hospitalo-Universitaire de Toulouse, Toulouse, France.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Cesari', 'Affiliation': 'Gérontopôle de Toulouse, Institut du Vieillissement, Centre Hospitalo-Universitaire de Toulouse, Toulouse, France.'}, {'ForeName': 'Philipe', 'Initials': 'P', 'LastName': 'de Souto Barreto', 'Affiliation': 'Gérontopôle de Toulouse, Institut du Vieillissement, Centre Hospitalo-Universitaire de Toulouse, Toulouse, France.'}]",American journal of Alzheimer's disease and other dementias,['10.1177/1533317518803773'] 1231,30384767,The Effect of Varying Incentive Amounts on Physician Survey Response.,"A major challenge with surveying physicians is low response. In this article, we present results of an experiment conducted to determine the optimal monetary incentive amount for gaining response from physicians to a short screener survey. Sampled physicians were randomly assigned to three prepaid cash incentive conditions (US$2, US$5, US$10) compared to a control (US$0). This study found using any incentive increased response versus no incentive. The US$10 incentive produced the highest response and was significantly greater than the US$2 incentive group. However, we did not find a statistical difference between the $5 and US$10 incentives or between the US$2 and US$5 incentives. In addition, any incentive amount increased the likelihood of early response compared to no incentive. This study builds on previously mixed results about the effects of various incentive amounts and effect on early survey response. These findings provide practical advice for researchers surveying physicians.",2019,The US$10 incentive produced the highest response and was significantly greater than the US$2 incentive group.,[],"['prepaid cash incentive conditions (US$2, US$5, US$10) compared to a control (US$0']",['likelihood of early response'],[],"[{'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}]",,0.0152771,The US$10 incentive produced the highest response and was significantly greater than the US$2 incentive group.,"[{'ForeName': 'HarmoniJoie', 'Initials': 'H', 'LastName': 'Noel', 'Affiliation': 'American Institutes for Research, Washington, DC, USA.'}, {'ForeName': 'Alison R', 'Initials': 'AR', 'LastName': 'Huang', 'Affiliation': 'American Institutes for Research, Washington, DC, USA.'}]",Evaluation & the health professions,['10.1177/0163278718809844'] 1232,30325875,"A Feasibility Study of a Multifaceted Walking Intervention to Maintain the Functional Mobility, Activities of Daily Living, and Quality of Life of Nursing Home Residents With Dementia.","PURPOSE The aim of the study was to evaluate the feasibility, acceptability, and efficacy of a multifaceted walking intervention (MWI) aimed to maintain the functional mobility, activities of daily living function, and quality of life of long-term care home residents with dementia. DESIGN/METHODS A quasiexperimental time-series design was used. The 4-month intervention provided one-on-one walking 2-4 days a week, guided by an individualized communication care plan and interviews with collaterals and staff. RESULTS The MWI was feasible based on high recruitment and adherence rates (86% and 94%, respectively) and highly acceptable to stakeholders. Residents (n = 25) showed significant improvements after the intervention: Timed Up-and-Go (-8.85 seconds, p = .00), Two-Minute Walk Test (27.47 m, p = .00), Functional Independence Measure (0.72, p = .00), and Alzheimer's Disease-Related Quality of Life (2.44, p = .05). CONCLUSION The MWI was feasible and improved functional mobility compared to usual care. CLINICAL RELEVANCE Physical activity delivered with a person-centered care was feasible and may be beneficial to mitigate decline in long-term care home residents with dementia.",2020,"Timed Up-and-Go (-8.85 seconds, p = .00), Two-Minute Walk Test (27.47 m, p = .00), Functional Independence Measure (0.72, p = .00), and Alzheimer's Disease-Related Quality of Life (2.44, p = .05). ","['of long-term care home residents with dementia', 'Nursing Home Residents With Dementia']","['multifaceted walking intervention (MWI', 'Multifaceted Walking Intervention']","[""Alzheimer's Disease-Related Quality of Life"", 'functional mobility, activities of daily living function, and quality of life', 'functional mobility', 'Functional Mobility, Activities of Daily Living, and Quality of Life', 'adherence rates', 'Functional Independence Measure', 'feasibility, acceptability, and efficacy']","[{'cui': 'C0023977'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0497327', 'cui_str': 'Amentia'}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}]","[{'cui': 'C0205291', 'cui_str': 'Multifaceted (qualifier value)'}, {'cui': 'C0080331', 'cui_str': 'Walking'}]","[{'cui': 'C0002395', 'cui_str': 'Alzheimer Dementia'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C0001288', 'cui_str': 'ADL'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0451172', 'cui_str': 'Functional independence measure (assessment scale)'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}]",,0.0273704,"Timed Up-and-Go (-8.85 seconds, p = .00), Two-Minute Walk Test (27.47 m, p = .00), Functional Independence Measure (0.72, p = .00), and Alzheimer's Disease-Related Quality of Life (2.44, p = .05). ","[{'ForeName': 'Charlene H', 'Initials': 'CH', 'LastName': 'Chu', 'Affiliation': 'Department of Occupational Therapy and Occupational Science, Faculty of Medicine, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Martine', 'Initials': 'M', 'LastName': 'Puts', 'Affiliation': 'Lawrence S. Bloomberg Faculty of Nursing, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Dina', 'Initials': 'D', 'LastName': 'Brooks', 'Affiliation': 'Department of Physical Therapy and Rehabilitation Sciences Institute, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Parry', 'Affiliation': 'Lawrence S. Bloomberg Faculty of Nursing, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Katherine S', 'Initials': 'KS', 'LastName': 'McGilton', 'Affiliation': 'Lawrence S. Bloomberg Faculty of Nursing, University of Toronto, Toronto, Ontario, Canada.'}]",Rehabilitation nursing : the official journal of the Association of Rehabilitation Nurses,['10.1097/rnj.0000000000000186'] 1233,31659559,Endoscopic submucosal dissection of distal intestinal tumors using grasping forceps for traction.,"BACKGROUND The aim of this study was to assess the efficacy of traction device-assisted endoscopic submucosal dissection (ESD) of the rectum and the distal segment of sigmoid colon using grasping forceps. METHODS A total of 43 patients scheduled for colonic ESD at our institution were enrolled between January 2013 and June 2017. The patients were randomly allocated to receive conventional ESD (group A) or traction device-assisted ESD (group B). The procedure time, complication rate, and en-block resection rate in the two groups were compared. RESULTS A total of 41 patients completed the study. The procedure time, complication rate and en-block resection rate were, respectively, 104.1 ± 34.7 min, 15%, 90% in the routine group (group A) and 84.7 ± 23.5 min, 9.5%, 90.5% in traction device-assisted ESD (group B). The procedure time in group B was significantly less than that in group A (F = 4.442, p < 0.05). CONCLUSIONS Traction device-assisted ESD using grasping forceps is safe and effective in distal colon ESD.",2019,"The procedure time in group B was significantly less than that in group A (F = 4.442, p < 0.05). ","['43 patients scheduled for colonic ESD at our institution were enrolled between January 2013 and June 2017', '41 patients completed the study']","['Endoscopic submucosal dissection', 'traction device-assisted endoscopic submucosal dissection (ESD', 'Traction device-assisted ESD using grasping forceps', 'traction device-assisted ESD', 'conventional ESD']","['procedure time, complication rate, and en-block resection rate', 'procedure time, complication rate and en-block resection rate']","[{'cui': 'C0030703', 'cui_str': 'Schedules, Patient'}, {'cui': 'C0009368', 'cui_str': 'Colon'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C1700929', 'cui_str': 'Endoscopic Submucosal Dissection'}, {'cui': 'C3872768', 'cui_str': 'Traction device'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C3472334', 'cui_str': 'Grasping forceps'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}]","[{'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}]",,0.0214843,"The procedure time in group B was significantly less than that in group A (F = 4.442, p < 0.05). ","[{'ForeName': 'F', 'Initials': 'F', 'LastName': 'Wang', 'Affiliation': 'Xuzhou Medical University, No. 3 Yingrui Road, Jiangyin, China.'}, {'ForeName': 'X', 'Initials': 'X', 'LastName': 'Leng', 'Affiliation': 'Xuzhou Medical University, No. 3 Yingrui Road, Jiangyin, China.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Gao', 'Affiliation': 'Xuzhou Medical University, No. 3 Yingrui Road, Jiangyin, China.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Zhao', 'Affiliation': 'Xuzhou Medical University, No. 3 Yingrui Road, Jiangyin, China.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'Xuzhou Medical University, No. 3 Yingrui Road, Jiangyin, China.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Bian', 'Affiliation': 'Xuzhou Medical University, No. 3 Yingrui Road, Jiangyin, China.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'Xuzhou Medical University, No. 3 Yingrui Road, Jiangyin, China.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Liu', 'Affiliation': 'Xuzhou Medical University, No. 3 Yingrui Road, Jiangyin, China. pengfeimd@hotmail.com.'}]",Techniques in coloproctology,['10.1007/s10151-019-02102-x'] 1234,29461972,Diet enriched with fresh coconut decreases blood glucose levels and body weight in normal adults.,,2018,,['normal adults'],['Diet enriched with fresh coconut'],['blood glucose levels and body weight'],"[{'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0453339', 'cui_str': 'Fresh coconut (substance)'}]","[{'cui': 'C0428554', 'cui_str': 'Blood glucose result - finding'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}]",,0.0106593,,"[{'ForeName': 'Venugopal', 'Initials': 'V', 'LastName': 'Vijayakumar', 'Affiliation': 'Division of Yoga and Life Sciences, S-VYASA University, Bengaluru, Karnataka, India.'}, {'ForeName': 'Nagashree R', 'Initials': 'NR', 'LastName': 'Shankar', 'Affiliation': 'Division of Yoga and Life Sciences, S-VYASA University, Bengaluru, Karnataka, India.'}, {'ForeName': 'Ramesh', 'Initials': 'R', 'LastName': 'Mavathur', 'Affiliation': 'Division of Yoga and Life Sciences, S-VYASA University, Bengaluru, Karnataka, India.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Mooventhan', 'Affiliation': 'All India Institute of Medical Sciences (AIIMS), Department of Yoga, Center for Integrative Medicine and Research (CIMR), New Delhi, India.'}, {'ForeName': 'Sood', 'Initials': 'S', 'LastName': 'Anju', 'Affiliation': 'S-VYASA University, and MD, Diet and Weight Management Health Centre, Division of Yoga and Life Sciences, Bengaluru, India.'}, {'ForeName': 'N K', 'Initials': 'NK', 'LastName': 'Manjunath', 'Affiliation': 'Division of Yoga and Life Sciences, and Head, Department of Research and Development, S-VYASA University, Bengaluru, Karnataka,India.'}]",Journal of complementary & integrative medicine,['10.1515/jcim-2017-0097'] 1235,30293208,Effect of Synbiotic and Probiotic Supplementation on Serum Levels of Endothelial Cell Adhesion Molecules in Hemodialysis Patients: a Randomized Control Study.,"The aim of this study was to investigate the effect of synbiotic and probiotic supplementation on serum vascular dysfunction and necrosis markers in hemodialysis (HD) patients. In this randomized, double-blind, placebo-controlled trial, 75 HD patients were randomly assigned to either the synbiotic or probiotic or placebo group. The patients in the synbiotic group received 15 g of prebiotics and 5 g probiotic powder containing Lactobacillus acidophilus strain T16 (IBRC-M10785), Bifidobacterium bifidum strain BIA-6, Bifidobacterium lactis strain BIA-6, Bifidobacterium longum strain LAF-5 (2.7 × 10 7  CFU/g each) in sachets (n = 25), whereas the probiotic group received 5 g probiotics same to the first group with 15 g of maltodextrin powder in sachets (n = 25) and the placebo group received 20 g of maltodextrin powder in sachets (n = 25) for 12 weeks. At baseline and the end of the study, serum concentrations of soluble intercellular adhesion molecule type 1 (sICAM-1), soluble vascular cell adhesion molecule type 1 (sVCAM-1), cytokeratin 18 (CK-18) as the necrosis marker, uric acid, and phosphate levels were measured. Feces also were collected for microbiota colony counting. Serum ICAM-1 level reduced significantly in the synbiotic group after the intervention period (P = 0.02), and this reduction was significantly different in the synbiotic group in comparison to the placebo group (P = 0.03). Serum levels of VCAM-1 and CK-18 were not significantly different between the groups. However, the reduction in serum levels of VCAM-1 in the synbiotic group was significantly higher in comparison to the placebo group (P = 0.01). Multivariate linear regression analysis revealed that ∆ phosphate was the sole independent determinant of ∆ICAM-1 (P = 0 < 001). The study indicated that synbiotic supplementation reduced serum ICAM-1 level, which is a risk factor for cardiovascular diseases in HD patients, but has no effect on the necrosis marker. Trial registration: www.irct.ir (IRCT2017041233393N1).",2019,"Serum ICAM-1 level reduced significantly in the synbiotic group after the intervention period (P = 0.02), and this reduction was significantly different in the synbiotic group in comparison to the placebo group (P = 0.03).","['hemodialysis (HD) patients', '75 HD patients', 'HD patients', 'Hemodialysis Patients']","['placebo group received 20\xa0g of maltodextrin powder in sachets', 'placebo', 'maltodextrin powder in sachets', 'synbiotic and probiotic supplementation', 'synbiotic or probiotic or placebo', 'synbiotic supplementation', '15\xa0g of prebiotics and 5\xa0g probiotic powder containing Lactobacillus acidophilus strain T16 (IBRC-M10785), Bifidobacterium bifidum strain BIA-6, Bifidobacterium lactis strain BIA-6, Bifidobacterium longum strain LAF-5', 'Synbiotic and Probiotic Supplementation']","['Serum levels of VCAM-1 and CK-18', 'serum levels of VCAM-1', 'Serum ICAM-1 level', 'serum vascular dysfunction and necrosis markers', 'serum ICAM-1 level', 'serum concentrations of soluble intercellular adhesion molecule type 1 (sICAM-1), soluble vascular cell adhesion molecule type 1 (sVCAM-1), cytokeratin 18 (CK-18) as the necrosis marker, uric acid, and phosphate levels', 'Serum Levels of Endothelial Cell Adhesion Molecules']","[{'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0450403', 'cui_str': '20G (qualifier value)'}, {'cui': 'C0065601', 'cui_str': 'maltodextrin'}, {'cui': 'C0032861', 'cui_str': 'Powdered drug preparation'}, {'cui': 'C4319662', 'cui_str': 'Sachet'}, {'cui': 'C2936470', 'cui_str': 'Synbiotics'}, {'cui': 'C0525033', 'cui_str': 'Probiotics'}, {'cui': 'C2717875', 'cui_str': 'Prebiotics'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0022939', 'cui_str': 'Lactobacillus acidophilus'}, {'cui': 'C0080194', 'cui_str': 'Strains'}, {'cui': 'C0314974', 'cui_str': 'Bifidobacterium bifidum'}, {'cui': 'C1001866', 'cui_str': 'Bifidobacterium animalis subsp. lactis'}, {'cui': 'C0314977', 'cui_str': 'Bifidobacterium longum'}, {'cui': 'C0021755', 'cui_str': 'T Helper Factor'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0078056', 'cui_str': 'CD106 Antigens'}, {'cui': 'C0063695', 'cui_str': 'CD54 Antigens'}, {'cui': 'C0031847', 'cui_str': 'pathophysiology'}, {'cui': 'C0027540', 'cui_str': 'Necrosis'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0242565', 'cui_str': 'Intercellular Adhesion Molecules'}, {'cui': 'C0441729', 'cui_str': 'Type 1 (qualifier value)'}, {'cui': 'C0010805', 'cui_str': 'Cytokeratin 18'}, {'cui': 'C0041980', 'cui_str': 'Uric Acid'}, {'cui': 'C0523826', 'cui_str': 'Phosphate measurement (procedure)'}, {'cui': 'C0225336', 'cui_str': 'Endothelial Cells'}, {'cui': 'C0001511', 'cui_str': 'Tissue Adhesions'}, {'cui': 'C0567416', 'cui_str': 'Molecule (substance)'}]",75.0,0.220696,"Serum ICAM-1 level reduced significantly in the synbiotic group after the intervention period (P = 0.02), and this reduction was significantly different in the synbiotic group in comparison to the placebo group (P = 0.03).","[{'ForeName': 'Neda', 'Initials': 'N', 'LastName': 'Haghighat', 'Affiliation': 'Department of Nutrition, Nutrition and Metabolic Diseases Research Center, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Majid', 'Initials': 'M', 'LastName': 'Mohammadshahi', 'Affiliation': 'Department of Nutrition, Nutrition and Metabolic Diseases Research Center, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran. shahi334@gmail.com.'}, {'ForeName': 'Shokouh', 'Initials': 'S', 'LastName': 'Shayanpour', 'Affiliation': 'Department of Nephrology, Golestan Hospital, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}, {'ForeName': 'Mohammad Hossein', 'Initials': 'MH', 'LastName': 'Haghighizadeh', 'Affiliation': 'Department of Biostatistics and Epidemiology, Faculty of Public Health, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.'}]",Probiotics and antimicrobial proteins,['10.1007/s12602-018-9477-9'] 1236,30446480,What Is the Role of Increasing Inhaled Corticosteroid Therapy in Worsening Asthma in Children?,"The treatment of ""yellow zone,"" or worsening, asthma in children remains controversial. The 2018 Global Initiative for Asthma strategy recommends increasing the dose of inhaled corticosteroid (ICS) for the short (1-2 weeks) or longer (3 months) term in children older than 5 years with worsening asthma. In contrast, the National Heart, Lung, and Blood Institute's Expert Panel Report 3 guideline for the diagnosis and management of asthma notes that doubling the dose of ICS therapy is ""not sufficient"" in worsening asthma, as does the Canadian Thoracic Society guideline on asthma management in children. Both guidelines do comment that higher than double dosing may be effective. In particular, the Expert Panel Report 3 guideline specifies that more than doubling the dose of ICS therapy may be useful in the emergency department management of worsening asthma, because it may prevent oral corticosteroid requirement. The Canadian Thoracic Society suggests that adolescents (older than 12 years) quadruple ICS maintenance dosing by 4- or 5-fold for 7 to 14 days with worsening asthma if there is a history of a severe exacerbation in the past year. All these recommendations were published before a recent, large randomized double-blind controlled trial by Jackson et al that further calls into question the efficacy of increased ICS dosing in worsening asthma in children. The goal of this Rostrum was to review available data and consider the role of increasing doses of ICS and potential alternative approaches to this common practice.",2019,that adolescents (older than 12 years) quadruple ICS maintenance dosing by 4- or 5-fold for 7 to 14 days with worsening asthma if there is a history of a severe exacerbation in the past year.,"['children', 'children older than 5 years with worsening asthma', 'worsening asthma in children', 'adolescents (older than 12 years']","['ICS', 'ICS therapy', 'inhaled corticosteroid (ICS', 'quadruple ICS maintenance']",[],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}, {'cui': 'C0205175', 'cui_str': 'Quadruple (qualifier value)'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}]",[],,0.104678,that adolescents (older than 12 years) quadruple ICS maintenance dosing by 4- or 5-fold for 7 to 14 days with worsening asthma if there is a history of a severe exacerbation in the past year.,"[{'ForeName': 'Elissa M', 'Initials': 'EM', 'LastName': 'Abrams', 'Affiliation': 'Department of Pediatrics, Section of Allergy and Clinical Immunology, University of Manitoba, Winnipeg, MB, Canada. Electronic address: elissa.abrams@gmail.com.'}, {'ForeName': 'Stanley J', 'Initials': 'SJ', 'LastName': 'Szefler', 'Affiliation': ""Department of Pediatrics, Section of Pediatric Pulmonary and Sleep Medicine, University of Colorado School of Medicine and The Breathing Institute, Children's Hospital Colorado, Aurora, Colo.""}, {'ForeName': 'Allan B', 'Initials': 'AB', 'LastName': 'Becker', 'Affiliation': 'Department of Pediatrics, Section of Allergy and Clinical Immunology, University of Manitoba, Winnipeg, MB, Canada.'}]",The journal of allergy and clinical immunology. In practice,['10.1016/j.jaip.2018.10.004'] 1237,30239857,Comparison of Early Nasal Intermittent Positive Pressure Ventilation and Nasal Continuous Positive Airway Pressure in Preterm Infants with Respiratory Distress Syndrome.,"AIMS To compare the effect of early nasal intermittent positive pressure ventilation (nIPPV) and nasal continuous positive airway pressure (nCPAP) in terms of the need for endotracheal ventilation in the treatment of respiratory distress syndrome (RDS) in preterm infants born between 24 and 32 gestational weeks. METHODS This is a randomized, controlled, prospective, single-centered study. Forty-two infants were randomized to nIPPV and 42 comparable infants to nCPAP (birth weight 1356 ± 295 and 1359 ± 246 g and gestational age 29.2 ± 1.7 and 29.4 ± 1.5 weeks, respectively). RESULTS The need for endotracheal intubation and invasive mechanical ventilation was significantly lower in the nIPPV group than the nCPAP group (11.9% and 40.5%, respectively, p < 0.05). There were no differences in the duration of total nasal respiratory support, duration of invasive mechanical ventilation, bronchopulmonary dysplasia or other early morbidities. CONCLUSION nIPPV compared with nCPAP reduced the need for endotracheal intubation and invasive mechanical ventilation in premature infants with RDS.",2019,"The need for endotracheal intubation and invasive mechanical ventilation was significantly lower in the nIPPV group than the nCPAP group (11.9% and 40.5%, respectively, p < 0.05).","['Preterm Infants with Respiratory Distress Syndrome', 'premature infants with RDS', 'Forty-two infants were randomized to nIPPV and 42 comparable infants to nCPAP (birth weight 1356\u2009±\u2009295 and 1359\u2009±', '246\xa0g and gestational age 29.2\u2009±\u20091.7 and 29.4\u2009±\u20091.5\u2009weeks, respectively', 'preterm infants born between 24 and 32 gestational weeks']","['Early Nasal Intermittent Positive Pressure Ventilation and Nasal Continuous Positive Airway Pressure', 'nCPAP', 'early nasal intermittent positive pressure ventilation (nIPPV) and nasal continuous positive airway pressure (nCPAP']","['respiratory distress syndrome (RDS', 'need for endotracheal intubation and invasive mechanical ventilation', 'endotracheal intubation and invasive mechanical ventilation', 'duration of total nasal respiratory support, duration of invasive mechanical ventilation, bronchopulmonary dysplasia or other early morbidities']","[{'cui': 'C4048294', 'cui_str': 'Preterm Infant'}, {'cui': 'C0035220', 'cui_str': 'Respiratory Distress Syndrome, Newborn'}, {'cui': 'C4319566', 'cui_str': 'Forty-two'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0005612', 'cui_str': 'Birth Weight'}, {'cui': 'C0017504', 'cui_str': 'Fetal Maturity, Chronologic'}, {'cui': 'C4517512', 'cui_str': '1.7 (qualifier value)'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0439671', 'cui_str': 'Gestational (qualifier value)'}]","[{'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C4520890', 'cui_str': 'Nasal'}, {'cui': 'C0021778', 'cui_str': 'IPPV'}, {'cui': 'C1258045', 'cui_str': 'Nasal Continuous Positive Airway Pressure'}]","[{'cui': 'C0035220', 'cui_str': 'Respiratory Distress Syndrome, Newborn'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}, {'cui': 'C0021932', 'cui_str': 'Intubation, Endotracheal'}, {'cui': 'C1868981', 'cui_str': 'Invasive mechanical ventilation'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4520890', 'cui_str': 'Nasal'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0006287', 'cui_str': 'Bronchopulmonary Dysplasia'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}]",42.0,0.11106,"The need for endotracheal intubation and invasive mechanical ventilation was significantly lower in the nIPPV group than the nCPAP group (11.9% and 40.5%, respectively, p < 0.05).","[{'ForeName': 'Mesut', 'Initials': 'M', 'LastName': 'Dursun', 'Affiliation': 'Specialist in Neonatology, Division of Neonatology, Department of Pediatrics, Sisli Hamidiye Etfal Education and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Sinan', 'Initials': 'S', 'LastName': 'Uslu', 'Affiliation': 'Assistance Professor, Specialist in Neonatology, Division of Neonatology, Department of Pediatrics, Sisli Hamidiye Etfal Education and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Bulbul', 'Affiliation': 'Assistance Professor, Specialist in Neonatology, Division of Neonatology, Department of Pediatrics, Sisli Hamidiye Etfal Education and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Muhittin', 'Initials': 'M', 'LastName': 'Celik', 'Affiliation': 'Specialist in Neonatology, Division of Neonatology, Department of Pediatrics, Sisli Hamidiye Etfal Education and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Umut', 'Initials': 'U', 'LastName': 'Zubarioglu', 'Affiliation': 'Specialist in Neonatology, Division of Neonatology, Department of Pediatrics, Sisli Hamidiye Etfal Education and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Evrim Kiray', 'Initials': 'EK', 'LastName': 'Bas', 'Affiliation': 'Specialist in Neonatology, Division of Neonatology, Department of Pediatrics, Sisli Hamidiye Etfal Education and Research Hospital, Istanbul, Turkey.'}]",Journal of tropical pediatrics,['10.1093/tropej/fmy058'] 1238,31654535,Comparing interferon-free with interferon-based regimens in HCV patients: Rogers phenomenon and Simpson's paradox.,"Comparisons of time-to-event clinical outcomes between patients with or without a sustained virological response (SVR) after treatment of chronic hepatitis C infection have been repeatedly reported in emphasizing the potential clinical impact of treatment. Combining recently published data from different therapeutic eras with simple examples, we show that comparisons of incidence rates by SVR status between patients treated with interferon-based and interferon-free regimens are flawed through confounding by prognosis. The relevant analysis for evaluating and comparing the clinical impact of these regimens should be a comparison between randomized treatment groups, irrespective of the SVR status.",2020,Comparisons of time-to-event clinical outcomes between patients with or without a sustained virological response (SVR) after treatment of chronic hepatitis C infection have been repeatedly reported in emphasizing the potential clinical impact of treatment.,"['HCV patients', 'patients with or without a sustained virological response (SVR) after treatment of chronic hepatitis C infection']",['Interferon-free with Interferon-based regimens'],[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205466', 'cui_str': 'virology'}, {'cui': 'C0001758', 'cui_str': 'Follow-Up Care'}, {'cui': 'C0524910', 'cui_str': 'Hepatitis C, Chronic'}, {'cui': 'C3714514', 'cui_str': 'Infection'}]","[{'cui': 'C0021747', 'cui_str': 'Interferons'}, {'cui': 'C0178499', 'cui_str': 'Base'}]",[],,0.0387477,Comparisons of time-to-event clinical outcomes between patients with or without a sustained virological response (SVR) after treatment of chronic hepatitis C infection have been repeatedly reported in emphasizing the potential clinical impact of treatment.,"[{'ForeName': 'Fabrice', 'Initials': 'F', 'LastName': 'Carrat', 'Affiliation': ""Sorbonne Université, INSERM, Institut Pierre Louis d'Épidémiologie et de Santé Publique, Paris, France.""}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Nahon', 'Affiliation': 'Université Sorbonne Paris Cité, INSERM, UMR 1162, Université Paris 13, Paris, France.'}, {'ForeName': 'Hélène', 'Initials': 'H', 'LastName': 'Fontaine', 'Affiliation': ""Hôpital Cochin, Unité d'Hépatologie, Assistance Publique-Hôpitaux de Paris, Paris, France.""}, {'ForeName': 'Stanislas', 'Initials': 'S', 'LastName': 'Pol', 'Affiliation': ""Hôpital Cochin, Unité d'Hépatologie, Assistance Publique-Hôpitaux de Paris, Paris, France.""}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Hejblum', 'Affiliation': ""Sorbonne Université, INSERM, Institut Pierre Louis d'Épidémiologie et de Santé Publique, Paris, France.""}]",Journal of viral hepatitis,['10.1111/jvh.13225'] 1239,31930518,"Effects of the cognitive stimulation therapy based on Roy's adaptation model on Alzheimer's patients' cognitive functions, coping-adaptation skills, and quality of life: A randomized controlled trial.","PURPOSE This study aims to specify the effects of Cognitive Stimulation Therapy based on Roy's adaptation model (RAM) on Alzheimer's patients' coping and adaptation skills, cognitive functions, and quality of life (QOL). DESIGN AND METHODS This is an experimental and randomized controlled trial. Patients in the experimental group received cognitive stimulation therapy (CST) based on RAM. FINDINGS The cognitive function level of the experimental group was found to be higher than that of the control group at the end of the measurements (performed in the 7th week); the difference was found to be statistically significant (P < .05). In the experimental group, dimensions of troubleshooting and focusing, making physical decisions, attention processing, systematizing, learning, and establishing relationships were found to be better than those of the control group after the application, and the difference was found to be statistically significant (P < .05). However, after the application, QOL of the experimental group was found to be better than that of the control group following the measurements; the difference was found to be statistically significant (P < .05). PRACTICE IMPLICATIONS Psychiatric nurses should evaluate the patients using Standardize Mini-Mental Test Examination before applying RAM-based CST, and they should apply CST to early- and mid-stage Alzheimer's disease (AD) patients at the end of the evaluation and work with groups consisting of six persons at most. Since the cognitive functions of individuals with AD decline from the first stage, coping-adaptation, and QOL levels will also be affected, so it is recommended to evaluate the cognitive functions, coping-adjustment and QOL levels of individuals before applying RAM-based CST. TRIAL REGISTRATION NUMBER NCT02229474.",2020,The cognitive function level of the experimental group was found to be higher than that of the control group at the end of the measurements (performed in the 7th week); the difference was found to be statistically significant (P < .05).,"[""Alzheimer's patients""]","['cognitive stimulation therapy (CST', 'cognitive stimulation therapy', ""Cognitive Stimulation Therapy based on Roy's adaptation model (RAM""]","['dimensions of troubleshooting and focusing, making physical decisions, attention processing, systematizing, learning, and establishing relationships', 'coping and adaptation skills, cognitive functions, and quality of life (QOL', 'QOL', 'cognitive function level', 'cognitive functions, coping-adaptation skills, and quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0150174', 'cui_str': 'Cognitive stimulation (regime/therapy)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0560172', 'cui_str': 'cSt'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0392673', 'cui_str': 'Adaptation, function (observable entity)'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}]","[{'cui': 'C0439534', 'cui_str': 'Dimensions (qualifier value)'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0443211', 'cui_str': 'Established (qualifier value)'}, {'cui': 'C0439849', 'cui_str': 'Relationships (qualifier value)'}, {'cui': 'C0392673', 'cui_str': 'Adaptation, function (observable entity)'}, {'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}, {'cui': 'C0034380'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",,0.0365173,The cognitive function level of the experimental group was found to be higher than that of the control group at the end of the measurements (performed in the 7th week); the difference was found to be statistically significant (P < .05).,"[{'ForeName': 'Neslihan', 'Initials': 'N', 'LastName': 'Lok', 'Affiliation': 'Department of Psychiatric Nursing, Faculty of Nursing, Selcuk University, Konya, Turkey.'}, {'ForeName': 'Kadriye', 'Initials': 'K', 'LastName': 'Buldukoglu', 'Affiliation': 'Department of Psychiatric Nursing, Faculty of Nursing, Akdeniz University, Antalya, Turkey.'}, {'ForeName': 'Ebru', 'Initials': 'E', 'LastName': 'Barcin', 'Affiliation': 'Department of Neurology, Faculty of Medicine, Akdeniz University, Antalya, Turkey.'}]",Perspectives in psychiatric care,['10.1111/ppc.12472'] 1240,30244669,Can the severity of orofacial myofunctional conditions interfere with the response of analgesia promoted by active or placebo low-level laser therapy?,"OBJECTIVE To analyze the influence of orofacial myofunctional condition (OMC) on pain perception, temporomandibular disorders (TMD) severity, and the response to low-level laser therapy (LLLT) in women with painful TMD. METHODS Seventy-eight women, 59 with TMD, received active laser (30) or placebo (29), with 19 controls. OMC, TMD severity, pain intensity, and pressure pain threshold (PPT) were assessed at different times during the masticatory test: before treatment (LLLT dose: 780nm), during, and after 30 days. RESULTS No correlation was found between OMC and pain perception or TMD severity ( p  > 0.05). The active and placebo LLLT showed reduction of pain during chewing and better recovery levels during the rest period ( p  > 0.05), without differences between OMC groups. DISCUSSION The perception of pain and severity of TMD are not correlated with the OMC, and the response of analgesia promoted by active LLLT or placebo is not associated with OMC.",2020,"The active and placebo LLLT showed reduction of pain during chewing and better recovery levels during the rest period (p > 0.05), without differences between OMC groups. ","['women with painful TMD', '29), with 19 controls', 'Seventy-eight women, 59 with TMD, received']","['placebo', 'placebo LLLT', 'active laser (30) or placebo', 'low-level laser therapy (LLLT', 'orofacial myofunctional condition (OMC']","['pain perception, temporomandibular disorders (TMD) severity', 'perception of pain and severity of TMD', 'OMC, TMD severity, pain intensity, and pressure pain threshold (PPT', 'OMC and pain perception or TMD severity', 'pain during chewing and better recovery levels']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C3816957', 'cui_str': '70'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4019433', 'cui_str': 'LLLT'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0023089', 'cui_str': 'Lasers'}, {'cui': 'C0279027', 'cui_str': 'Low-Power Laser Therapy'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C3714605', 'cui_str': 'Pain Perception'}, {'cui': 'C0039494', 'cui_str': 'TMJ Diseases'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0162703', 'cui_str': 'Pain Threshold'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",78.0,0.139141,"The active and placebo LLLT showed reduction of pain during chewing and better recovery levels during the rest period (p > 0.05), without differences between OMC groups. ","[{'ForeName': 'Carolina Almeida', 'Initials': 'CA', 'LastName': 'Rodrigues', 'Affiliation': 'Department of Restorative Dentistry, School of Dentistry, University of São Paulo , Ribeirão Preto, SP, Brazil.'}, {'ForeName': 'Melissa de Oliveira', 'Initials': 'MO', 'LastName': 'Melchior', 'Affiliation': 'Department of Restorative Dentistry, School of Dentistry, University of São Paulo , Ribeirão Preto, SP, Brazil.'}, {'ForeName': 'Laís', 'Initials': 'L', 'LastName': 'Valencise Magri', 'Affiliation': 'Department of Restorative Dentistry, School of Dentistry, University of São Paulo , Ribeirão Preto, SP, Brazil.'}, {'ForeName': 'Marcelo Oliveira', 'Initials': 'MO', 'LastName': 'Mazzetto', 'Affiliation': 'Department of Restorative Dentistry, School of Dentistry, University of São Paulo , Ribeirão Preto, SP, Brazil.'}]",Cranio : the journal of craniomandibular practice,['10.1080/08869634.2018.1520950'] 1241,30215301,Does occlusal splint affect posture? A randomized controlled trial.,"OBJECTIVE The aim of this study was to evaluate the effect of an occlusal splint on body posture of intra-articular temporomandibular joint (TMJ) disorders patients. METHODS The study was performed on 45 women affected by TMJ disorders divided into an occlusal splint group and a control group. Rasterstereographic recordings were performed at baseline and after 1, 3, and 6 months, in order to analyze the following postural parameters: trunk inclination, cervical and lumbar arrows, kyphotic and lordotic angles, trunk imbalance, pelvic tilt and torsion. RESULTS Regarding the postural parameters in the intragroup analysis, no significant differences were detected. The analysis between the two groups revealed significant differences concerning the cervical arrow, the kyphotic and lordotic angles. DISCUSSION Even if some differences were found between the control and the occlusal splint group, the low range of statistical significance made these results not significant from a clinical point of view.",2020,"The analysis between the two groups revealed significant differences concerning the cervical arrow, the kyphotic and lordotic angles. ","['intra-articular temporomandibular joint (TMJ) disorders patients', '45 women affected by TMJ disorders divided into an occlusal splint group and a control group']",['occlusal splint'],"['cervical arrow, the kyphotic and lordotic angles']","[{'cui': 'C0442108', 'cui_str': 'Intra-articular (qualifier value)'}, {'cui': 'C0039494', 'cui_str': 'TMJ Diseases'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0162528', 'cui_str': 'Occlusal Splints'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0162528', 'cui_str': 'Occlusal Splints'}]","[{'cui': 'C0205064', 'cui_str': 'Cervical (qualifier value)'}, {'cui': 'C0336721', 'cui_str': 'Arrow, device (physical object)'}, {'cui': 'C0205143', 'cui_str': 'Angular (qualifier value)'}]",45.0,0.0328171,"The analysis between the two groups revealed significant differences concerning the cervical arrow, the kyphotic and lordotic angles. ","[{'ForeName': 'Ilaria', 'Initials': 'I', 'LastName': 'De Giorgi', 'Affiliation': 'Department of Surgical Sciences, Gnathology Unit, Dental School, University of Torino , Torino, Italy.'}, {'ForeName': 'Tommaso', 'Initials': 'T', 'LastName': 'Castroflorio', 'Affiliation': 'Department of Surgical Sciences, Specialization School of Orthodontics, Dental School, University of Torino , Torino, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Cugliari', 'Affiliation': 'Department of Statistics and Quantitative Methods, University of Milano-Bicocca , Milan, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Deregibus', 'Affiliation': 'Department of Surgical Sciences, Gnathology Unit, Dental School, University of Torino , Torino, Italy.'}]",Cranio : the journal of craniomandibular practice,['10.1080/08869634.2018.1511265'] 1242,29698340,Teaching Point-of-Care Lung Ultrasound to Novice Pediatric Learners: Web-Based E-Learning Versus Traditional Classroom Didactic.,"OBJECTIVE To assess whether Web-based teaching is at least as effective as traditional classroom didactic in improving the proficiency of pediatric novice learners in the image acquisition and interpretation of pneumothorax and pleural effusion using point-of-care ultrasound (POCUS). METHODS We conducted a randomized controlled noninferiority study comparing the effectiveness of Web-based teaching to traditional classroom didactic. The participants were randomized to either group A (live classroom lecture) or group B (Web-based lecture) and completed a survey and knowledge test. They also received hands-on training and completed an objective structured clinical examination. The participants were invited to return 2 months later to test for retention of knowledge and skills. RESULTS There were no significant differences in the mean written test scores between the classroom group and Web group for the precourse test (absolute difference, -2.5; 95% confidence interval [CI], -12 to 6.9), postcourse test (absolute difference, 2.0; 95% CI, -1.4, 5.3), and postcourse 2-month retention test (absolute difference, -0.8; 95% CI, -9.6 to 8.1). Similarly, no significant differences were noted in the mean objective structured clinical examination scores for both intervention groups in postcourse (absolute difference, 1.9; 95% CI, -4.7 to 8.5) and 2-month retention (absolute difference, -0.6; 95% CI, -10.7 to 9.5). CONCLUSIONS Web-based teaching is at least as effective as traditional classroom didactic in improving the proficiency of novice learners in POCUS. The usage of Web-based tutorials allows a more efficient use of time and a wider dissemination of knowledge.",2020,"There were no significant differences in the mean written test scores between the classroom group and Web group for the precourse test (absolute difference, -2.5; 95% confidence interval [CI], -12 to 6.9), postcourse test (absolute difference, 2.0; 95% CI, -1.4, 5.3), and postcourse 2-month retention test (absolute difference, -0.8; 95% CI, -9.6 to 8.1).",['Novice Pediatric Learners'],"['Web-based teaching to traditional classroom didactic', ' Web-Based E-Learning', 'group A (live classroom lecture']","['mean objective structured clinical examination scores', 'mean written test scores', '2-month retention']","[{'cui': 'C0030755', 'cui_str': 'Pediatrics'}]","[{'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0039401', 'cui_str': 'Teaching'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0441835', 'cui_str': 'Group A (qualifier value)'}, {'cui': 'C0376683', 'cui_str': 'Lecture'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0031809', 'cui_str': 'Physical Examination'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0035280', 'cui_str': 'Retention'}]",,0.102566,"There were no significant differences in the mean written test scores between the classroom group and Web group for the precourse test (absolute difference, -2.5; 95% confidence interval [CI], -12 to 6.9), postcourse test (absolute difference, 2.0; 95% CI, -1.4, 5.3), and postcourse 2-month retention test (absolute difference, -0.8; 95% CI, -9.6 to 8.1).","[{'ForeName': 'Aun Woon', 'Initials': 'AW', 'LastName': 'Soon', 'Affiliation': ""From the Women's and Children's Hospital, North Adelaide, South Australia, Australia.""}, {'ForeName': 'Amanda Greene', 'Initials': 'AG', 'LastName': 'Toney', 'Affiliation': 'Denver Health Medical Center.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Stidham', 'Affiliation': ""Children's Hospital Colorado.""}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Kendall', 'Affiliation': 'Denver Health Medical Center University of Colorado.'}, {'ForeName': 'Genie', 'Initials': 'G', 'LastName': 'Roosevelt', 'Affiliation': 'Denver Health Medical Center, Denver, CO.'}]",Pediatric emergency care,['10.1097/PEC.0000000000001482'] 1243,30165804,Evaluation of effusion and articular disc positioning after two different arthrocentesis techniques in patients with temporomandibular joint disc displacement without reduction.,"OBJECTIVE To evaluate joint effusion and positioning of the articular disc through magnetic resonance imaging (MRI) before and after two different arthrocentesis techniques. METHODS Twenty-six patients with dislocation of the articular disc without reduction (ADDwoR) were included and randomly divided into two groups: single needle arthrocentesis with distention of the upper compartment of the TMJ (A1) and conventional arthrocentesis with 2 needles (A2). RESULTS A statistically significant difference was observed between the different effusion categories ( p  = 0.009). No differences were found comparing both treatment modalities concerning the position of the mandibular condyle and the articular disc. CONCLUSION Conventional arthrocentesis was able to change the effusion variable, whereas the single needle arthrocentesis was not. Both techniques were responsible for altering the position of the mandibular head or the disc-head complex, projecting them to a more anterior position related to the increase in the final maximum interincisal distance.",2020,"No differences were found comparing both treatment modalities concerning the position of the mandibular condyle and the articular disc. ","['patients with temporomandibular joint disc displacement without reduction', 'Twenty-six patients with dislocation of the articular disc without reduction (ADDwoR']","['single needle arthrocentesis with distention of the upper compartment of the TMJ (A1) and conventional arthrocentesis with 2 needles (A2', 'magnetic resonance imaging (MRI']",[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1290686', 'cui_str': 'Temporomandibular joint disc displacement'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0450349', 'cui_str': '26 (qualifier value)'}, {'cui': 'C0012691', 'cui_str': 'Joint Dislocations'}, {'cui': 'C0224498', 'cui_str': 'Meniscus'}]","[{'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0398296', 'cui_str': 'Cannulation of vascular fistula, graft or prosthetic device (procedure)'}, {'cui': 'C0204854', 'cui_str': 'Arthrocentesis'}, {'cui': 'C3714614', 'cui_str': 'Distention'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0039493', 'cui_str': 'TMJ'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C1552358', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}]",[],26.0,0.0203364,"No differences were found comparing both treatment modalities concerning the position of the mandibular condyle and the articular disc. ","[{'ForeName': 'Primo Guilherme Vargas', 'Initials': 'PGV', 'LastName': 'Pasqual', 'Affiliation': 'Department of Dentistry, Faculty of Medicine, Federal University of Rio Grande do Sul , Porto Alegre, RS, Brazil.'}, {'ForeName': 'Rodrigo Lorenzi', 'Initials': 'RL', 'LastName': 'Poluha', 'Affiliation': 'Department of Dentistry, State University of Maringá , Maringá, PR, Brazil.'}, {'ForeName': 'Ênio Tadashi', 'Initials': 'ÊT', 'LastName': 'Setogutti', 'Affiliation': 'Private Clinic , Porto Alegre, RS, Brazil.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Grossmann', 'Affiliation': 'Department of Dentistry, Craniofacial Pain Applied to Dentistry, Dentistry Faculty, Federal University of Rio Grande do Sul , Porto Alegre, RS, Brazil.'}]",Cranio : the journal of craniomandibular practice,['10.1080/08869634.2018.1511266'] 1244,30022377,"How Does Health Education Given to Lung Cancer Patients Before Thoracotomy Affect Pain, Anxiety, and Respiratory Functions?","In this study, it was aimed to determine how the postoperative pain level, state-trait anxiety level, and respiratory function were affected by the health education given through a patient education booklet to patients with lung cancer, in comparison with control group, before pulmonary resection through thoracotomy. The 60 patients (n = 60) having pulmonary resection indication because of lung cancer were recruited in the present study. The patients were separated as control (n = 30) and experimental groups (n = 30). The patient education was applied to patients in the experimental groups via the education booklet 24 h before the surgery. Patients in the control groups received only usual clinical nursing information. The pain was evaluated via visual analog scale (VAS). The State-Trait Anxiety Scale (STAS) was used for evaluating the anxiety level. The evaluated pulmonary functions were peak expiratory flow (PEF), forced vital capacity (FVC), forced expiratory volume in 1 s (FEV1), and forced expiratory flow 25-75 (FEF25-75). The pain level of the experimental group was statistically lower than control group (p < 0.05). The state anxiety level of experimental group received education was statistically lower than control group (p < 0.05). There was no any statistical difference in trait anxiety levels between control and experimental groups (p > 0.05). The FEV1 and FEF25-75 values in experimental group were statistically higher than control group. A planned health education applied via the thoracotomy patient education booklet has a positive effect on clinical recovery process by affecting postoperative pain, state anxiety, and FEV1 and FEF25-75 values.",2019,The pain level of the experimental group was statistically lower than control group (p < 0.05).,"['Lung Cancer Patients', '60 patients (n\u2009=\u200960) having pulmonary resection indication because of lung cancer']",['usual clinical nursing information'],"['trait anxiety levels', 'State-Trait Anxiety Scale (STAS', 'Pain, Anxiety, and Respiratory Functions', 'pain was evaluated via visual analog scale (VAS', 'peak expiratory flow (PEF), forced vital capacity (FVC), forced expiratory volume in 1\xa0s (FEV1), and forced expiratory flow 25-75 (FEF25-75', 'FEV1 and FEF25-75 values', 'state anxiety level', 'postoperative pain level, state-trait anxiety level, and respiratory function', 'pain level']","[{'cui': 'C1306460', 'cui_str': 'Primary malignant neoplasm of lung'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0396565', 'cui_str': 'Lung excision'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0028678', 'cui_str': 'nursing care'}]","[{'cui': 'C0564474', 'cui_str': 'Level of anxiety (observable entity)'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0222045'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0035203', 'cui_str': 'Breathing'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0231800', 'cui_str': 'Exhalation'}, {'cui': 'C3714541', 'cui_str': 'Forced Vital Capacity'}, {'cui': 'C1306036', 'cui_str': 'Forced expiratory volume'}, {'cui': 'C3804964', 'cui_str': 'Forced expiratory flow'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}]",,0.0193302,The pain level of the experimental group was statistically lower than control group (p < 0.05).,"[{'ForeName': 'Hatice Esra', 'Initials': 'HE', 'LastName': 'Cetkin', 'Affiliation': 'Department of Nursing, Institute of Health Science, Sanko University, İncilipınar Mah., Gazi Muhtar Pasa Bulv. No:36, 27090, Şehitkamil, Gaziantep, Turkey. es-ra85@hotmail.com.'}, {'ForeName': 'Arzu', 'Initials': 'A', 'LastName': 'Tuna', 'Affiliation': 'Department of Nursing, Institute of Health Science, Sanko University, İncilipınar Mah., Gazi Muhtar Pasa Bulv. No:36, 27090, Şehitkamil, Gaziantep, Turkey.'}]",Journal of cancer education : the official journal of the American Association for Cancer Education,['10.1007/s13187-018-1401-1'] 1245,31407212,"Pilot Randomized Controlled Trial of a Syndemics Intervention with HIV-Positive, Cocaine-Using Women.","This pilot randomized controlled trial examined the feasibility and acceptability of a Syndemics intervention targeting the intersection of stimulant use, trauma, and difficulties with HIV disease management in cocaine-using women. All participants received contingency management (CM) for 3 months with financial incentives for stimulant abstinence during thrice-weekly urine screening and refilling antiretroviral medications monthly. Sixteen participants were randomized to complete four expressive writing (n = 9) or four neutral writing (n = 7) sessions delivered during the CM intervention period. Completion rates for writing sessions were high (15 of 16 women completed all four sessions) and engagement in CM urine screening was moderate with women randomized to expressive writing providing a median of 11 non-reactive urine samples for stimulants. There were non-significant trends for those randomized to expressive writing to provide more CM urine samples that were non-reactive for stimulants, report greater decreases in severity of cocaine use, and display reductions in log 10 HIV viral load at 6 months. Although the Syndemics intervention was feasible and acceptable to many women, qualitative interviews with eligible participants who were not randomized identified structural and psychological barriers to engagement. Further clinical research is needed to test the efficacy of Syndemics interventions with HIV-positive, cocaine-using women.",2019,"There were non-significant trends for those randomized to expressive writing to provide more CM urine samples that were non-reactive for stimulants, report greater decreases in severity of cocaine use, and display reductions in log 10 HIV viral load at 6 months.","['Using Women', 'Sixteen participants', 'cocaine-using women']","['Syndemics Intervention with HIV-Positive, Cocaine', 'contingency management (CM', 'Syndemics intervention', 'expressive writing (n\u2009=\u20099) or four neutral writing (n\u2009=\u20097) sessions delivered during the CM intervention period']",[],"[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0009170', 'cui_str': 'Cocaine'}]","[{'cui': 'C4704689', 'cui_str': 'Syndemic'}, {'cui': 'C0019699', 'cui_str': 'HTLV-III Seroconversion'}, {'cui': 'C0009170', 'cui_str': 'Cocaine'}, {'cui': 'C0043266', 'cui_str': 'Writing'}]",[],16.0,0.156203,"There were non-significant trends for those randomized to expressive writing to provide more CM urine samples that were non-reactive for stimulants, report greater decreases in severity of cocaine use, and display reductions in log 10 HIV viral load at 6 months.","[{'ForeName': 'Danita', 'Initials': 'D', 'LastName': 'Jemison', 'Affiliation': 'Department of Public Health Sciences, School of Medicine, University of Miami, Miami, USA.'}, {'ForeName': 'Sequoia', 'Initials': 'S', 'LastName': 'Jackson', 'Affiliation': 'Department of Public Health Sciences, School of Medicine, University of Miami, Miami, USA.'}, {'ForeName': 'Olorunleke', 'Initials': 'O', 'LastName': 'Oni', 'Affiliation': 'Department of Family Medicine, Jackson Memorial Hospital, Miami, USA.'}, {'ForeName': 'Deva', 'Initials': 'D', 'LastName': 'Cats-Baril', 'Affiliation': 'Department of Public Health Sciences, School of Medicine, University of Miami, Miami, USA.'}, {'ForeName': 'Shawdae', 'Initials': 'S', 'LastName': 'Thomas-Smith', 'Affiliation': 'Department of Family Medicine, John H. Stroger Hospital, Chicago, USA.'}, {'ForeName': 'Abigail', 'Initials': 'A', 'LastName': 'Batchelder', 'Affiliation': 'Department of Psychiatry, Harvard Medical School/Massachusetts General Hospital, Boston, USA.'}, {'ForeName': 'Allan', 'Initials': 'A', 'LastName': 'Rodriguez', 'Affiliation': 'Department of Medicine, School of Medicine, University of Miami, Miami, USA.'}, {'ForeName': 'Samantha E', 'Initials': 'SE', 'LastName': 'Dilworth', 'Affiliation': 'Department of Medicine, School of Medicine, University of California, San Francisco, USA.'}, {'ForeName': 'Lisa R', 'Initials': 'LR', 'LastName': 'Metsch', 'Affiliation': 'Department of Sociomedical Sciences, Mailman School of Public Health, Columbia University, New York, USA.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Jones', 'Affiliation': 'Department of Public Health Sciences, School of Medicine, University of Miami, Miami, USA.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Feaster', 'Affiliation': 'Department of Public Health Sciences, School of Medicine, University of Miami, Miami, USA.'}, {'ForeName': 'Conall', 'Initials': 'C', 'LastName': ""O'Cleirigh"", 'Affiliation': 'Department of Psychiatry, Harvard Medical School/Massachusetts General Hospital, Boston, USA.'}, {'ForeName': 'Gail', 'Initials': 'G', 'LastName': 'Ironson', 'Affiliation': 'Department of Psychology, College of Arts and Sciences, University of Miami, Coral Gables, USA.'}, {'ForeName': 'Adam W', 'Initials': 'AW', 'LastName': 'Carrico', 'Affiliation': 'Department of Public Health Sciences, School of Medicine, University of Miami, Miami, USA. a.carrico@miami.edu.'}]",AIDS and behavior,['10.1007/s10461-019-02625-2'] 1246,29958232,Stand Tall-A Virtual Translation of the Otago Exercise Program.,"BACKGROUND AND PURPOSE The Otago Exercise Program (OEP) is effective at preventing falls and fall-related injuries. The resources and personnel required for program delivery and challenges inherent in monitoring participant adherence and compliance pose significant barriers to increasing the number of older adults participating in the OEP. Alternative delivery systems using virtual platforms may pose a solution. The purposes of this article were to (1) describe the ""Stand Tall"" intervention, a virtual translation of the OEP; (2) describe Stand Tall participant characteristics and fall-related risk at baseline; and (3) identify changes in physical performance measures associated with fall risk from baseline to 8-week follow-up. METHODS This was a quasi-experimental, single-group, pretest-posttest design. Forty-two older adults at risk for falls were recruited. Participants were oriented to Stand Tall by study personnel and then monitored and progressed virtually with face to face check-ins. Participants independently logged in and completed a prescribed a set of exercises 3 times a week for 30 minutes for a total of 8 weeks. RESULTS AND DISCUSSION The average participant age was 75.0 (9.1) years and self-reported 2.3 (1.7) chronic conditions. There were more men than women (52.4%) in the study. Participants were primarily non-Hispanic white (90.5%), had a college education (61.9), 40% reported falling in the past 6 months, and 60% screened positive for mild cognitive impairment. Participants were beginning to show decline in function with average single-leg stance less than 10 seconds and 30-second chair rise scores below normative values. Participants demonstrated high adherence rates (>88%) and significant improvements in physical performance measures associated with fall risk. These results may be limited to a less frail population and the study was not powered to demonstrate a reduction in falls. CONCLUSIONS Results support that an avatar-delivered version of the OEP is effective, feasible, viable, and enjoyable for community-dwelling older adults. These types of platforms should be considered as potential mechanisms to increase availability of fall prevention programs.",2020,"CONCLUSIONS Results support that an avatar-delivered version of the OEP is effective, feasible, viable, and enjoyable for community-dwelling older adults.","['community-dwelling older adults', 'Participants were primarily non-Hispanic white (90.5%), had a college education (61.9), 40% reported falling in the past 6 months, and 60% screened positive for mild cognitive impairment', 'older adults participating in the OEP', 'average participant age was 75.0 (9.1) years and self-reported 2.3 (1.7) chronic conditions', 'Forty-two older adults at risk for falls were recruited']",['Otago Exercise Program (OEP'],"['physical performance measures', 'adherence rates']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0000921', 'cui_str': 'Falls'}, {'cui': 'C1444637', 'cui_str': 'In the past'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C1270972', 'cui_str': 'Mild Neurocognitive Disorder'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C4517512', 'cui_str': '1.7 (qualifier value)'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C4319566', 'cui_str': 'Forty-two'}, {'cui': 'C1268740', 'cui_str': 'Fall risk'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C2607857'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}]",42.0,0.0230576,"CONCLUSIONS Results support that an avatar-delivered version of the OEP is effective, feasible, viable, and enjoyable for community-dwelling older adults.","[{'ForeName': 'Tiffany E', 'Initials': 'TE', 'LastName': 'Shubert', 'Affiliation': 'Shubert Consulting, Chapel Hill, North Carolina.'}, {'ForeName': 'Anang', 'Initials': 'A', 'LastName': 'Chokshi', 'Affiliation': 'Reflexion Health, San Diego, California.'}, {'ForeName': 'Victoria M', 'Initials': 'VM', 'LastName': 'Mendes', 'Affiliation': 'Shubert Consulting, Chapel Hill, North Carolina.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Grier', 'Affiliation': 'Reflexion Health, San Diego, California.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Buchanan', 'Affiliation': 'Division of Physical Therapy, The University of North Carolina at Chapel Hill.'}, {'ForeName': 'Jeanna', 'Initials': 'J', 'LastName': 'Basnett', 'Affiliation': 'Reflexion Health, San Diego, California.'}, {'ForeName': 'Matthew Lee', 'Initials': 'ML', 'LastName': 'Smith', 'Affiliation': 'Department of Environmental and Occupational Health, Center for Population Health and Aging, School of Public Health, Texas A&M University, College Station.'}]",Journal of geriatric physical therapy (2001),['10.1519/JPT.0000000000000203'] 1247,31604428,The impact of dexmedetomidine added to ropivicaine for transversus abdominis plane block on stress response in laparoscopic surgery: a randomized controlled trial.,"BACKGROUND Intravenous dexmedetomidine is known to attenuate stress response in patients undergoing laparoscopic surgery. We investigated whether the addition of the highly selective alpha-2 adrenergic agonist dexmedetomidine into ropivacaine for ultrasound-guided transversus abdominis plane block could inhibit stress response during laparoscopic surgery, and determined the optimal dose of dexmedetomidine in it. METHODS One hundred and twenty-five patients undergoing laparoscopic gynecological surgery were included in this prospective and randomized double-blind study. Patients received general anesthesia with or without a total of 60 ml of 0.2% ropivacaine in combination with low (0.25 μg/kg), medium (0.50 μg/kg) or high dose (1.0 μg/kg) of dexmedetomidine for the four-quadrant transversus abdominis plane block (n = 25). The primary outcomes were stress marker levels during the operation. RESULTS One hundred and twenty patients completed the study protocol. Dexmedetomidine added to ropivacaine for transversus abdominis plane block significantly reduced serum levels of cortisol, norepinephrine, epinephrine, interleukin-6, blood glucose, mean arterial pressure and heart rate in a dose-dependent manner (P < 0.05), accompanied with decreased anesthetic and opioid consumption during the operation (P < 0.05), but the high dose of dexmedetomidine induced higher incidences of bradycardia than low or medium dose of dexmedetomidine (P < 0.05). CONCLUSION The addition of dexmedetomidine at the dose of 0.5 μg/kg into ropivacaine for ultrasound-guided transversus abdominis plane block is the optimal dose to inhibit stress response with limited impact on blood pressure and heart rate in patients undergoing laparoscopy gynecological surgery. TRIAL REGISTRATION This study was registered at www.chictr.org.cn on November 6th, 2016 (ChiCTR-IOR-16009753).",2019,"Dexmedetomidine added to ropivacaine for transversus abdominis plane block significantly reduced serum levels of cortisol, norepinephrine, epinephrine, interleukin-6, blood glucose, mean arterial pressure and heart rate in a dose-dependent manner (P < 0.05), accompanied with decreased anesthetic and opioid consumption during the operation (P < 0.05), but the high dose of dexmedetomidine induced higher incidences of bradycardia than low or medium dose of dexmedetomidine (P < 0.05). ","['patients undergoing laparoscopic surgery', 'One hundred and twenty-five patients undergoing laparoscopic gynecological surgery', 'patients undergoing laparoscopy gynecological surgery', 'One hundred and twenty patients completed the study protocol', 'laparoscopic surgery']","['general anesthesia with or without a total of 60\u2009ml of 0.2% ropivacaine', 'dexmedetomidine', 'Dexmedetomidine', 'ropivacaine', 'dexmedetomidine into ropivacaine', 'ropivicaine']","['serum levels of cortisol, norepinephrine, epinephrine, interleukin-6, blood glucose, mean arterial pressure and heart rate', 'blood pressure and heart rate', 'bradycardia', 'stress marker levels during the operation', 'stress response', 'anesthetic and opioid consumption']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0751429', 'cui_str': 'Surgical Procedures, Laparoscopic'}, {'cui': 'C4319551', 'cui_str': 'One hundred and twenty-five'}, {'cui': 'C0038902', 'cui_str': 'Gynecological Surgical Procedure'}, {'cui': 'C0031150', 'cui_str': 'Celioscopy'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}]","[{'cui': 'C0002915', 'cui_str': 'General Anesthesia'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4517436', 'cui_str': '0.2'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}, {'cui': 'C0202145', 'cui_str': 'Norepinephrine measurement (procedure)'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C0428886', 'cui_str': 'Mean Arterial Pressure'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0428977', 'cui_str': 'Bradyarrhythmia'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0038895', 'cui_str': 'operative therapy'}, {'cui': 'C0002930', 'cui_str': 'Anesthesiology'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]",120.0,0.685686,"Dexmedetomidine added to ropivacaine for transversus abdominis plane block significantly reduced serum levels of cortisol, norepinephrine, epinephrine, interleukin-6, blood glucose, mean arterial pressure and heart rate in a dose-dependent manner (P < 0.05), accompanied with decreased anesthetic and opioid consumption during the operation (P < 0.05), but the high dose of dexmedetomidine induced higher incidences of bradycardia than low or medium dose of dexmedetomidine (P < 0.05). ","[{'ForeName': 'Zhaojun', 'Initials': 'Z', 'LastName': 'Qin', 'Affiliation': ""Department of Anesthesiology, the People's Hospital of China Three Gorges University & the First People's Hospital of Yichang, Yichang, Hubei, China.""}, {'ForeName': 'Chunyan', 'Initials': 'C', 'LastName': 'Xiang', 'Affiliation': ""Department of Pharmacy, the People's Hospital of China Three Gorges University & the First People's Hospital of Yichang, Yichang, Hubei, China.""}, {'ForeName': 'Hongbo', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': ""Department of Anesthesiology, the People's Hospital of Yuan'an County, Yichang, China.""}, {'ForeName': 'Tingting', 'Initials': 'T', 'LastName': 'Liu', 'Affiliation': ""Department of Anesthesiology, the People's Hospital of China Three Gorges University & the First People's Hospital of Yichang, Yichang, Hubei, China.""}, {'ForeName': 'Leyun', 'Initials': 'L', 'LastName': 'Zhan', 'Affiliation': ""Department of Anesthesiology, the People's Hospital of China Three Gorges University & the First People's Hospital of Yichang, Yichang, Hubei, China.""}, {'ForeName': 'Zhengyuan', 'Initials': 'Z', 'LastName': 'Xia', 'Affiliation': 'Department of Anesthesiology, the University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Zhang', 'Affiliation': ""Department of Anesthesiology, the People's Hospital of China Three Gorges University & the First People's Hospital of Yichang, Yichang, Hubei, China.""}, {'ForeName': 'Jianping', 'Initials': 'J', 'LastName': 'Lai', 'Affiliation': ""Department of Nuclear Medicine, the People's Hospital of China Three Gorges University & the First People's Hospital of Yichang, 2 Jiefang Road, Xiling District, Yichang City, Hubei, China. 279522080@qq.com.""}]",BMC anesthesiology,['10.1186/s12871-019-0859-7'] 1248,30477346,"Comments on ""Nonsurgical Treatment of De Quervain Tenosynovitis: A Prospective Randomized Trial"".",,2019,,['De Quervain Tenosynovitis'],[],[],"[{'cui': 'C0149870', 'cui_str': 'Stenosing Tenosynovitis, De Quervain'}]",[],[],,0.0176729,,"[{'ForeName': 'Jad', 'Initials': 'J', 'LastName': 'Abi-Rafeh', 'Affiliation': 'McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Roy', 'Initials': 'R', 'LastName': 'Kazan', 'Affiliation': 'McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Thibaudeau', 'Affiliation': 'McGill University Health Center, Montreal, Quebec, Canada.'}]","Hand (New York, N.Y.)",['10.1177/1558944718813734'] 1249,29987586,Evaluation of Health Belief Model-Based Intervention on Breast Cancer Screening Behaviors among Health Volunteers.,"Breast cancer is the most common cancer and the second leading cause of death among women. Regarding the lack of knowledge about the cause of breast cancer and considering the fact that all women are prone to this disease, training on methods of early diagnosis to reduce its complications is of great importance. Thus, this study aimed to determine the effect of education based on the health belief model on breast cancer screening behaviors in health volunteers of health centers in Isfahan. In this experimental study, 480 healthy volunteers were randomly divided into two groups: the case (n = 240) and control (n = 240). The training program was designed according to health belief model structures. Before the training interventional program, the Champion standard questionnaire and functional checklist were completed for both groups. A standard questionnaire was completed during three stages (before, immediately after, and 2 months after the training). The experimental group received the educational intervention during eight sessions, and the collected data was eventually analyzed using the SPSS statistical software version 16 with relevant statistical tests. Participation of all individuals in the present research was voluntary and with informed consent. The results showed that mean scores of knowledge, perceived susceptibility, severity, benefits, barriers, self-efficacy, and behavioral intention related to breast self-examination (BSE) and mammography in the intervention group significantly increased compared with those of the control group immediately after and 2 months after educational intervention. There was a significant difference between groups in BSE skill 2 months after the intervention, but there was no significant difference between the two groups in BSE behavior and mammography 2 months after the intervention. The results confirmed the efficiency and effectiveness of an educational intervention based on the health belief model on improving factors affecting breast cancer screening behaviors.",2019,The results confirmed the efficiency and effectiveness of an educational intervention based on the health belief model on improving factors affecting breast cancer screening behaviors.,"['Breast Cancer Screening Behaviors among Health Volunteers', '480 healthy volunteers', 'health volunteers of health centers in Isfahan']","['educational intervention', 'Health Belief Model-Based Intervention']","['BSE skill', 'mean scores of knowledge, perceived susceptibility, severity, benefits, barriers, self-efficacy, and behavioral intention related to breast self-examination (BSE) and mammography', 'efficiency and effectiveness']","[{'cui': 'C0281182', 'cui_str': 'Breast cancer screening'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C4319609', 'cui_str': '480'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0475309', 'cui_str': 'Health center (environment)'}]","[{'cui': 'C3714363', 'cui_str': 'Health belief model (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C1264642', 'cui_str': 'Susceptibility (property) (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0085105', 'cui_str': 'Breast Self-Examination'}, {'cui': 'C0024671', 'cui_str': 'Mammography'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}]",480.0,0.0117454,The results confirmed the efficiency and effectiveness of an educational intervention based on the health belief model on improving factors affecting breast cancer screening behaviors.,"[{'ForeName': 'Mohtasham', 'Initials': 'M', 'LastName': 'Ghaffari', 'Affiliation': 'Environmental and Occupational Hazards Control Research Center, School of Public Health, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Sanaz Nasiri', 'Initials': 'SN', 'LastName': 'Esfahani', 'Affiliation': 'Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Sakineh', 'Initials': 'S', 'LastName': 'Rakhshanderou', 'Affiliation': 'Environmental and Occupational Hazards Control Research Center, School of Public Health, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Parisa Hosseini', 'Initials': 'PH', 'LastName': 'Koukamari', 'Affiliation': 'School of Public Health, Shahid Beheshti University of Medical Sciences, Tehran, Iran. Hosseinikoukamari.parisa@gmail.com.'}]",Journal of cancer education : the official journal of the American Association for Cancer Education,['10.1007/s13187-018-1394-9'] 1250,30027807,Examining the Impact of Group Size on the Treatment Intensity of a Tier 2 Mathematics Intervention Within a Systematic Framework of Replication.,"Group size and treatment intensity are understudied topics in mathematics intervention research. This study examined whether the treatment intensity and overall intervention effects of an empirically validated Tier 2 mathematics intervention varied between intervention groups with 2:1 and 5:1 student-teacher ratios. Student practice opportunities and the quality of explicit instruction served as treatment intensity metrics. A total of 465 kindergarten students with mathematics difficulties from 136 intervention groups participated. Results suggested comparable performances between the 2:1 and 5:1 intervention groups on six outcome measures. Observation data indicated that student practice differed by group size. Students in the 5:1 groups received more opportunities to practice with their peers, while students in the 2:1 groups participated in more frequent and higher quality individualized practice opportunities. Implications in terms of delivering Tier 2 interventions in small-group formats and engaging at-risk learners in meaningful practice opportunities are discussed.",2019,Results suggested comparable performances between the 2:1 and 5:1 intervention groups on six outcome measures.,['465 kindergarten students with mathematics difficulties from 136 intervention groups participated'],[],[],"[{'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0024934', 'cui_str': 'Mathematics'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C4517568', 'cui_str': 'One hundred and thirty-six'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]",[],[],465.0,0.0185637,Results suggested comparable performances between the 2:1 and 5:1 intervention groups on six outcome measures.,"[{'ForeName': 'Christian T', 'Initials': 'CT', 'LastName': 'Doabler', 'Affiliation': 'University of Texas at Austin, Austin, TX, USA.'}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Clarke', 'Affiliation': 'University of Oregon, Eugene, OR, USA.'}, {'ForeName': 'Derek', 'Initials': 'D', 'LastName': 'Kosty', 'Affiliation': 'Oregon Research Institute, Eugene, OR, USA.'}, {'ForeName': 'Evangeline', 'Initials': 'E', 'LastName': 'Kurtz-Nelson', 'Affiliation': 'University of Oregon, Eugene, OR, USA.'}, {'ForeName': 'Hank', 'Initials': 'H', 'LastName': 'Fien', 'Affiliation': 'University of Oregon, Eugene, OR, USA.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Smolkowski', 'Affiliation': 'Oregon Research Institute, Eugene, OR, USA.'}, {'ForeName': 'Scott K', 'Initials': 'SK', 'LastName': 'Baker', 'Affiliation': 'University of Oregon, Eugene, OR, USA.'}]",Journal of learning disabilities,['10.1177/0022219418789376'] 1251,31539073,Effect of an Electronic Medication Reconciliation Intervention on Adverse Drug Events: A Cluster Randomized Trial.,"Importance Adverse drug events (ADEs) account for up to 16% of emergency department (ED) visits and 7% of hospital admissions. Medication reconciliation is required for hospital accreditation because it can reduce medication discrepancies, but there is no evidence that reducing discrepancies reduces ADEs or other adverse outcomes. Objective To evaluate whether electronic medication reconciliation reduces ADEs, medication discrepancies, and other adverse outcomes compared with usual care. Design, Setting, and Participants This cluster randomized trial involved 3491 patients who were discharged from 2 medical units and 2 surgical units at the McGill University Health Centre, Montreal, Quebec, Canada, between October 2014 and November 2016. Data analysis took place from July 2017 to July 2019. Intervention The RightRx intervention electronically retrieved community drugs from the provincial insurer and aligned them with in-hospital drugs to facilitate reconciliation and communication at care transitions. Main Outcomes and Measures The primary outcome was ADEs in 30 days after discharge. Secondary outcomes included medication discrepancies, ED visits, hospital readmissions, and a composite outcome of ED visits, readmissions, and death up to 90 days after discharge. Results Of 4656 eligible patients, 3567 (76.6%) consented to participate (2060 [57.8%] men; mean [SD] age, 69.8 [14.9] years). Overall, 76 patients died during the hospital stay, so 3491 patients were included in the analysis. There was no significant difference in the risk of ADEs between intervention and control groups (76 [4.6%] vs 73 [4.0%]; OR, 0.97; 95% CI, 0.33-1.48), ED visits (433 [26.2%] vs 488 [26.6%]; OR, 0.83; 95% CI, 0.36-1.42), hospital readmission (170 [10.3%] vs 261 [14.2%]; OR, 0.22; 95% CI, 0.06-1.14), or the composite outcome (447 [27.0%] vs 506 [27.6%]; OR, 0.75; 95% CI, 0.34-1.27) at 30 days. Medication discrepancies were significantly reduced in the intervention group compared with the control group (437 [26.4%] vs 1029 [56.0%]; OR, 0.24; 95% CI, 0.12-0.57). Changes made to community medications (OR, 1.05; 95% CI, 1.01-1.10) and new medications (OR, 1.09; 95% CI, 1.01-1.18) were significant risk factors for ADEs. Conclusions and Relevance Electronic medication reconciliation reduced medication discrepancies but did not reduce ADEs or other adverse outcomes. Hospital accreditation should focus on interventions that reduce the risk of adverse events for patients with multiple changes to community medications. Trial Registration ClinicalTrials.gov identifier: NCT01179867.",2019,"Medication discrepancies were significantly reduced in the intervention group compared with the control group (437 [26.4%] vs 1029 [56.0%]; OR, 0.24; 95% CI, 0.12-0.57).","['4656 eligible patients, 3567 (76.6%) consented to participate (2060 [57.8%] men', 'patients with multiple changes to community medications', 'mean [SD] age, 69.8 [14.9] years', '76 patients died during the hospital stay, so 3491 patients were included in the analysis', '3491 patients who were discharged from 2 medical units and 2 surgical units at the McGill University Health Centre, Montreal, Quebec, Canada, between October 2014 and November 2016']",['Electronic Medication Reconciliation Intervention'],"['risk of ADEs', 'Medication discrepancies', 'hospital readmission', 'ADEs in 30 days after discharge', 'medication discrepancies, ED visits, hospital readmissions, and a composite outcome of ED visits, readmissions, and death up to 90 days after discharge', 'Adverse Drug Events']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1306577', 'cui_str': 'On examination - dead (finding)'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0475309', 'cui_str': 'Health center (environment)'}, {'cui': 'C0034390', 'cui_str': 'Quebec'}, {'cui': 'C0006823', 'cui_str': 'Canada'}]","[{'cui': 'C4281784', 'cui_str': 'Electronics'}, {'cui': 'C2317067', 'cui_str': 'Medication Reconciliation'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C1290905', 'cui_str': 'Discrepancy'}, {'cui': 'C0600290', 'cui_str': 'Hospital Readmissions'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0041755', 'cui_str': 'Drug Side Effects'}]",76.0,0.202716,"Medication discrepancies were significantly reduced in the intervention group compared with the control group (437 [26.4%] vs 1029 [56.0%]; OR, 0.24; 95% CI, 0.12-0.57).","[{'ForeName': 'Robyn', 'Initials': 'R', 'LastName': 'Tamblyn', 'Affiliation': 'Department of Epidemiology, Biostatistics and Occupational Health, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Abrahamowicz', 'Affiliation': 'Department of Epidemiology, Biostatistics and Occupational Health, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'David L', 'Initials': 'DL', 'LastName': 'Buckeridge', 'Affiliation': 'Department of Epidemiology, Biostatistics and Occupational Health, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Bustillo', 'Affiliation': 'Clinical and Health Informatics Research Group, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Alan J', 'Initials': 'AJ', 'LastName': 'Forster', 'Affiliation': 'Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.'}, {'ForeName': 'Nadyne', 'Initials': 'N', 'LastName': 'Girard', 'Affiliation': 'Clinical and Health Informatics Research Group, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Bettina', 'Initials': 'B', 'LastName': 'Habib', 'Affiliation': 'Clinical and Health Informatics Research Group, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Hanley', 'Affiliation': 'Department of Epidemiology, Biostatistics and Occupational Health, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Allen', 'Initials': 'A', 'LastName': 'Huang', 'Affiliation': 'Division of Geriatric Medicine, University of Ottawa, Ottawa, Ontario, Canada.'}, {'ForeName': 'Siyana', 'Initials': 'S', 'LastName': 'Kurteva', 'Affiliation': 'Department of Epidemiology, Biostatistics and Occupational Health, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Todd C', 'Initials': 'TC', 'LastName': 'Lee', 'Affiliation': 'Department of Medicine, McGill University Health Center, Montreal, Quebec, Canada.'}, {'ForeName': 'Ari N', 'Initials': 'AN', 'LastName': 'Meguerditchian', 'Affiliation': 'Clinical and Health Informatics Research Group, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Moraga', 'Affiliation': 'Clinical and Health Informatics Research Group, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Aude', 'Initials': 'A', 'LastName': 'Motulsky', 'Affiliation': ""Centre de Recherche du Centre Hospitalier de l'Université de Montréal, School of Public Health, University of Montreal, Montreal, Quebec, Canada.""}, {'ForeName': 'Lina', 'Initials': 'L', 'LastName': 'Petrella', 'Affiliation': 'McGill University Health Centre, Montreal, Quebec, Canada.'}, {'ForeName': 'Daniala L', 'Initials': 'DL', 'LastName': 'Weir', 'Affiliation': 'Department of Epidemiology, Biostatistics and Occupational Health, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Winslade', 'Affiliation': 'Clinical and Health Informatics Research Group, McGill University, Montreal, Quebec, Canada.'}]",JAMA network open,['10.1001/jamanetworkopen.2019.10756'] 1252,31410514,Comparison Between the Protector™ Laryngeal Mask Airway and the Endotracheal Tube for Minimally Invasive Thyroid and Parathyroid Surgery.,"BACKGROUND Pharyngolaryngeal symptoms are a main concern after neck surgery. The Protector™ LMA is a new supraglottic airway device. The main purpose of this study was to evaluate whether application of the LMA Protector™ causes fewer pharyngolaryngeal symptoms than application of the endotracheal tube after minimally invasive total thyroidectomy and parathyroidectomy. METHODS This prospective, randomized controlled trial involved one university and one private practice clinic, during the period from January 2017 until November 2017. The patients were randomly allocated to two groups: ETT and LMA. Main outcomes were Numerical Rating Scale scores of postoperative dysphagia, pharyngodynia, and incisional pain. Secondary outcomes were the frequency of rescue analgesia (paracetamol) consumption and emergence cough. Data were recorded in the post-anesthesia care unit and at 1, 6, 12, and 24 h after surgery. RESULTS Data from 78 patients were included in the final analysis. Pharyngodynia scores were significantly lower in the LMA group, compared with the ETT group, at 1 h, 6 h and 12 h after surgery. Dysphagia and surgical incision pain scores were also significantly lower in the LMA group, compared with the ETT group, at 6 h and 12 h after surgery. The frequency of postoperative paracetamol consumption was significantly increased in the ETT group, compared with the LMA group. Finally, the LMA group had fewer episodes of emergence cough, compared with the ETT group. CONCLUSION The LMA Protector™ causes fewer pharyngolaryngeal symptoms than the ETT within 6 and 12 h after minimally invasive total thyroidectomy and parathyroidectomy. TRIAL REGISTRATION ClinicalTrials.gov Identifier NCT03098667.",2019,"The frequency of postoperative paracetamol consumption was significantly increased in the ETT group, compared with the LMA group.","['one university and one private practice clinic, during the period from January 2017 until November 2017', '78 patients were included in the final analysis']","['LMA Protector', 'Protector™ Laryngeal Mask Airway and the Endotracheal Tube', 'ETT and LMA', 'LMA']","['frequency of rescue analgesia (paracetamol) consumption and emergence cough', 'pharyngolaryngeal symptoms', 'Dysphagia and surgical incision pain scores', 'episodes of emergence cough', 'Numerical Rating Scale scores of postoperative dysphagia, pharyngodynia, and incisional pain', 'Pharyngodynia scores', 'frequency of postoperative paracetamol consumption']","[{'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0033174', 'cui_str': 'Private Practice'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}]","[{'cui': 'C0162645', 'cui_str': 'Laryngeal Mask Airway'}, {'cui': 'C0336630', 'cui_str': 'Endotracheal tube, device (physical object)'}]","[{'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0010200', 'cui_str': 'Complaining of cough (finding)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0011168', 'cui_str': 'Dysphagia'}, {'cui': 'C0184898', 'cui_str': 'Incision - attribute'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C3854543', 'cui_str': 'Pharyngodynia'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}]",,0.106549,"The frequency of postoperative paracetamol consumption was significantly increased in the ETT group, compared with the LMA group.","[{'ForeName': 'Georgios', 'Initials': 'G', 'LastName': 'Kotsovolis', 'Affiliation': 'Department of Anesthesia, 424 Army General Hospital, Thessaloniki, Greece. gskotsos@gmail.com.'}, {'ForeName': 'Ioannis', 'Initials': 'I', 'LastName': 'Pliakos', 'Affiliation': '1st Propedeutic Department of Surgery, AHEPA University Hospital, Thessaloniki, Greece.'}, {'ForeName': 'Stavros', 'Initials': 'S', 'LastName': 'Panidis', 'Affiliation': '1st Propedeutic Department of Surgery, AHEPA University Hospital, Thessaloniki, Greece.'}, {'ForeName': 'Dimitrios', 'Initials': 'D', 'LastName': 'Gkinas', 'Affiliation': 'Department of Anesthesia and Intensive Care, AHEPA University Hospital, Thessaloniki, Greece.'}, {'ForeName': 'Theodosios', 'Initials': 'T', 'LastName': 'Papavramidis', 'Affiliation': '1st Propedeutic Department of Surgery, AHEPA University Hospital, Thessaloniki, Greece.'}]",World journal of surgery,['10.1007/s00268-019-05122-8'] 1253,30102427,Abuse Potential of Buprenorphine/Samidorphan Combination Compared to Buprenorphine and Placebo: A Phase 1 Randomized Controlled Trial.,"Buprenorphine/samidorphan combination (BUP/SAM) is an opioid system modulator being investigated as adjunctive treatment for major depressive disorder. BUP/SAM is a fixed-dose combination of buprenorphine, a partial μ-opioid receptor agonist and κ-opioid receptor antagonist, and samidorphan, a μ-opioid receptor antagonist added to address the abuse and dependence potential of buprenorphine. In this study, we assessed the effect of samidorphan on the abuse potential of buprenorphine in the BUP/SAM combination in nondependent, recreational, adult opioid users (ClinicalTrials.gov ID: NCT02413281). Participants were randomized to 6 treatments in a blinded, Williams crossover design: placebo, BUP/SAM at the intended therapeutic dose (2 mg/2 mg), at 4-fold (8 mg/8 mg) and 8-fold (16 mg/16 mg) the therapeutic dose, and buprenorphine alone (8 mg and 16 mg). The primary end point was maximum effect (E max ) on the visual analog scale for ""at the moment"" Drug Liking. E max of Drug Liking for the BUP/SAM 2 mg/2 mg dose was similar to that for placebo (median within-subject difference [90% confidence interval]: 2.5 [0.0-9.0]). The supratherapeutic doses of BUP/SAM showed differences of small magnitude on Drug Liking E max compared to placebo. Drug Liking E max for all BUP/SAM doses were significantly lower than those observed for either buprenorphine dose alone. Fewer participants reported adverse events associated with abuse potential with BUP/SAM than with buprenorphine alone, and the overall safety profile of BUP/SAM was consistent with prior reports in healthy volunteers. These findings indicate that samidorphan substantially reduces the abuse potential of buprenorphine in the BUP/SAM combination.",2019,Drug Liking E max for all BUP/SAM doses were significantly lower than those observed for either buprenorphine dose alone.,"['major depressive disorder', 'healthy volunteers']","['buprenorphine alone', 'placebo', 'Buprenorphine/Samidorphan Combination', 'buprenorphine', 'samidorphan', 'Buprenorphine and Placebo', 'Buprenorphine/samidorphan combination (BUP/SAM', 'placebo, BUP/SAM']","['Drug Liking E max for all BUP/SAM doses', 'adverse events', 'overall safety profile of BUP/SAM', 'maximum effect (E max ) on the visual analog scale for ""at the moment"" Drug Liking', 'E max of Drug Liking']","[{'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0006405', 'cui_str': 'Buprenorphine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4277369', 'cui_str': '3-carboxamido-4-hydroxynaltrexone'}, {'cui': 'C1563296', 'cui_str': 'Systolic anterior movement of mitral valve'}]","[{'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C1563296', 'cui_str': 'Systolic anterior movement of mitral valve'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}]",,0.0716202,Drug Liking E max for all BUP/SAM doses were significantly lower than those observed for either buprenorphine dose alone.,"[{'ForeName': 'Sanjeev', 'Initials': 'S', 'LastName': 'Pathak', 'Affiliation': 'Alkermes, Inc., Waltham, MA, USA.'}, {'ForeName': 'Bradley', 'Initials': 'B', 'LastName': 'Vince', 'Affiliation': 'Vince & Associates Clinical Research | Altasciences, Overland Park, KS, USA.'}, {'ForeName': 'Debra', 'Initials': 'D', 'LastName': 'Kelsh', 'Affiliation': 'Vince & Associates Clinical Research | Altasciences, Overland Park, KS, USA.'}, {'ForeName': 'Megan J', 'Initials': 'MJ', 'LastName': 'Shram', 'Affiliation': 'University of Toronto, Department of Pharmacology & Toxicology, Toronto, ON, Canada.'}, {'ForeName': 'Beatrice', 'Initials': 'B', 'LastName': 'Setnik', 'Affiliation': 'University of Toronto, Department of Pharmacology & Toxicology, Toronto, ON, Canada.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Lu', 'Affiliation': 'Alkermes, Inc., Waltham, MA, USA.'}, {'ForeName': 'Narinder', 'Initials': 'N', 'LastName': 'Nangia', 'Affiliation': 'Alkermes, Inc., Waltham, MA, USA.'}, {'ForeName': 'Arielle D', 'Initials': 'AD', 'LastName': 'Stanford', 'Affiliation': 'Alkermes, Inc., Waltham, MA, USA.'}, {'ForeName': 'Elliot', 'Initials': 'E', 'LastName': 'Ehrich', 'Affiliation': 'Alkermes, Inc., Waltham, MA, USA.'}]",Journal of clinical pharmacology,['10.1002/jcph.1280'] 1254,31587707,Work-Related Medical Rehabilitation in Cancer: A Cluster-Randomized Multicenter Study.,"BACKGROUND Current guidelines recommend rehabilitative measures to alleviate dis- turbances resulting from cancer and its treatment. To give cancer survivors further assistance in getting back to work, work-related medical rehabilitation is currently being tested in Germany. In this cluster-randomized, multicenter trial, we studied the efficacy of work-related medical rehabilitation compared with conventional medical rehabilitation (trial no. DRKS00007770 in the German Clinical Trials Registry). METHODS A total of 484 cancer survivors of working age who were candidates for rehabilitation were recruited and assigned at random to either the intervention group (IG; work-related medical rehabilitation) or the control group (CG). The primary end- point was self-assessed function in a role one year after the end of rehabilitation, as evaluated with the health-related quality of life questionnaire of the European Organisation for Research and Treatment of Cancer (EORTC QLQ-C30). Further endpoints included symptom and function scales, subjective ability to work, coping with illness, and return to work. Neither the medical personnel nor the subjects were blinded. RESULTS One year after the end of rehabilitation, data from 379 subjects who par- ticipated in the last follow-up survey were evaluated. The intervention and control groups did not differ significantly either in the primary endpoint of role function (IG = 60.8 vs. CG = 57.6 out of a maximum of 100 points; p = 0.204) or in any of the secondary endpoints. A last observation carried forward analysis yielded com- parable results. At 12 months, 28.5% of the subjects in the IG and 25.3% of those in the CG were still unable to work. CONCLUSION This study did not reveal any significant clinically relevant advantage of work-related medical rehabilitation at one year. Future studies should determine whether a second period of rehabilitation might be helpful and whether selected subjects might benefit from the assistance of case managers beyond the period of rehabilitation.",2019,The intervention and control groups did not differ significantly either in the primary endpoint of role function (IG = 60.8 vs. CG = 57.6 out of a maximum of 100 points; p = 0.204) or in any of the secondary endpoints.,"['484 cancer survivors of working age who were candidates for rehabilitation', 'Cancer', '379 subjects who par- ticipated in the last follow-up survey were evaluated']","['conventional medical rehabilitation', 'intervention group (IG; work-related medical rehabilitation) or the control group (CG', 'work-related medical rehabilitation']","['symptom and function scales, subjective ability to work, coping with illness, and return to work', 'health-related quality of life questionnaire of the European Organisation for Research and Treatment of Cancer (EORTC QLQ-C30', 'role function']","[{'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0222045'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0221423', 'cui_str': 'Illness (finding)'}, {'cui': 'C0425105', 'cui_str': 'Back to Work'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0239307', 'cui_str': 'European (ethnic group)'}, {'cui': 'C0029237', 'cui_str': 'Organization (morphologic abnormality)'}, {'cui': 'C0035168'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0035820', 'cui_str': 'Role'}]",379.0,0.0368661,The intervention and control groups did not differ significantly either in the primary endpoint of role function (IG = 60.8 vs. CG = 57.6 out of a maximum of 100 points; p = 0.204) or in any of the secondary endpoints.,"[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Fauser', 'Affiliation': 'Institute for Social Medicine and Epidemiology, University of Lübeck; Department of Psychology & Methods, University of Bremen; Paracelsus-Klinik am See, Bad Gandersheim; AMEOS Reha Klinikum, Ratzeburg; MediClin Rose Klinik, Horn-Bad Meinberg; Klinik Bavaria, Freyung.'}, {'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Wienert', 'Affiliation': ''}, {'ForeName': 'Bijan', 'Initials': 'B', 'LastName': 'Zomorodbakhsch', 'Affiliation': ''}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Schmielau', 'Affiliation': ''}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Biester', 'Affiliation': ''}, {'ForeName': 'Hans-Ulrich', 'Initials': 'HU', 'LastName': 'Krüger', 'Affiliation': ''}, {'ForeName': 'Angelika', 'Initials': 'A', 'LastName': 'Presl', 'Affiliation': ''}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Bethge', 'Affiliation': ''}]",Deutsches Arzteblatt international,['10.3238/arztebl.2019.0592'] 1255,30914493,Safety of Positive Pressure Extubation Technique.,"BACKGROUND Laboratory studies suggest applying positive pressure without endotracheal suction during cuff deflation and extubation. Although some studies reported better physiological outcomes (e.g. arterial blood gases) with this technique, the safety of positive pressure extubation technique has not been well studied. The aim of this study was to determine the safety of the positive-pressure extubation technique compared with the traditional extubation technique in terms of incidence of complications. METHODS Adult subjects who were critically ill and on invasive mechanical ventilation who met extubation criteria were included. The subjects were randomly assigned to positive-pressure extubation ( n = 120) or to traditional extubation ( n = 120). Sequential tests for noninferiority and, when appropriate, for superiority were performed. Positive pressure was considered noninferior if the upper limit of the CI for the absolute risk difference did not exceed a threshold of 15% in favor of the traditional group, both in per protocol and intention-to-treat analyses. A P value of <.05 was considered significant. RESULTS A total of 236 subjects were included in the primary analysis (per protocol) (119 in the positive-pressure group and 117 in the traditional group). The incidence of overall major and minor complications, pneumonia, extubation failure, and reintubation was lower in the positive-pressure group than in the traditional group, with statistical significance for noninferiority both in the per protocol ( P < .001) and intention-to-treat ( P < .001) analyses. The lower incidence of major complications found in the positive-pressure group reached statistical significance for the superiority comparison, both in per protocol ( P = .03) and intention-to-treat ( P = .049) analyses. No statistically significant differences were found in the superiority comparison for overall complications, minor complications, pneumonia, extubation failure, and reintubation. CONCLUSIONS Positive pressure was safe and noninferior to traditional extubation methods. Furthermore, positive pressure has shown to be superior in terms of a lower incidence of major complications. (ClinicalTrials.gov registration NCT03174509.).",2019,"No statistically significant differences were found in the superiority comparison for overall complications, minor complications, pneumonia, extubation failure, and reintubation. ","['A total of 236 subjects were included in the primary analysis (per protocol) (119 in the positive-pressure group and 117 in the traditional group', 'Adult subjects who were critically ill and on invasive mechanical ventilation who met extubation criteria were included']","['traditional extubation technique', 'positive-pressure extubation ( n = 120) or to traditional extubation', 'positive-pressure extubation technique', 'Positive Pressure Extubation Technique']","['overall complications, minor complications, pneumonia, extubation failure, and reintubation', 'incidence of overall major and minor complications, pneumonia, extubation failure, and reintubation', 'Positive pressure', 'lower incidence of major complications']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0303409', 'cui_str': '117-In'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0010340', 'cui_str': 'Critically Ill'}, {'cui': 'C1868981', 'cui_str': 'Invasive mechanical ventilation'}, {'cui': 'C0553891', 'cui_str': 'Tracheal Extubation'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0553891', 'cui_str': 'Tracheal Extubation'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0026193', 'cui_str': 'Minors'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0553891', 'cui_str': 'Tracheal Extubation'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}]",236.0,0.231859,"No statistically significant differences were found in the superiority comparison for overall complications, minor complications, pneumonia, extubation failure, and reintubation. ","[{'ForeName': 'Mauro F', 'Initials': 'MF', 'LastName': 'Andreu', 'Affiliation': 'Department of Health Sciences, Physical Therapy, Universidad de la Matanza, San Justo, Buenos Aires, Argentina. maufede@hotmail.com.'}, {'ForeName': 'María E', 'Initials': 'ME', 'LastName': 'Dotta', 'Affiliation': 'Division of Respiratory Care and Physical Therapy, Hospital Donación Francisco Santojanni, Buenos Aires, Argentina.'}, {'ForeName': 'Marco G', 'Initials': 'MG', 'LastName': 'Bezzi', 'Affiliation': 'Division of Respiratory Care and Physical Therapy, Hospital Donación Francisco Santojanni, Buenos Aires, Argentina.'}, {'ForeName': 'Silvina', 'Initials': 'S', 'LastName': 'Borello', 'Affiliation': 'Division of Respiratory Care and Physical Therapy, Hospital Donación Francisco Santojanni, Buenos Aires, Argentina.'}, {'ForeName': 'Gimena P', 'Initials': 'GP', 'LastName': 'Cardoso', 'Affiliation': 'Division of Respiratory Care and Physical Therapy, Hospital Donación Francisco Santojanni, Buenos Aires, Argentina.'}, {'ForeName': 'Paula C', 'Initials': 'PC', 'LastName': 'Dib', 'Affiliation': 'Division of Respiratory Care and Physical Therapy, Hospital Donación Francisco Santojanni, Buenos Aires, Argentina.'}, {'ForeName': 'Silvina L', 'Initials': 'SL', 'LastName': 'García Schustereder', 'Affiliation': 'Division of Respiratory Care and Physical Therapy, Hospital Donación Francisco Santojanni, Buenos Aires, Argentina.'}, {'ForeName': 'Alejandra M', 'Initials': 'AM', 'LastName': 'Galloli', 'Affiliation': 'Division of Respiratory Care and Physical Therapy, Hospital Donación Francisco Santojanni, Buenos Aires, Argentina.'}, {'ForeName': 'Daniela R', 'Initials': 'DR', 'LastName': 'Castro', 'Affiliation': 'Division of Respiratory Care and Physical Therapy, Hospital Donación Francisco Santojanni, Buenos Aires, Argentina.'}, {'ForeName': 'Victoria L', 'Initials': 'VL', 'LastName': 'Di Giorgio', 'Affiliation': 'Division of Respiratory Care and Physical Therapy, Hospital Donación Francisco Santojanni, Buenos Aires, Argentina.'}, {'ForeName': 'Federico J', 'Initials': 'FJ', 'LastName': 'Villalba', 'Affiliation': 'Division of Respiratory Care and Physical Therapy, Hospital Donación Francisco Santojanni, Buenos Aires, Argentina.'}, {'ForeName': 'Matías N', 'Initials': 'MN', 'LastName': 'Bertozzi', 'Affiliation': 'Department of Health Sciences, Physical Therapy, Universidad de la Matanza, San Justo, Buenos Aires, Argentina.'}, {'ForeName': 'Juan M', 'Initials': 'JM', 'LastName': 'Carballo', 'Affiliation': 'Division of Respiratory Care and Physical Therapy, Hospital Donación Francisco Santojanni, Buenos Aires, Argentina.'}, {'ForeName': 'María C', 'Initials': 'MC', 'LastName': 'Martín', 'Affiliation': 'Division of Respiratory Care and Physical Therapy, Hospital Donación Francisco Santojanni, Buenos Aires, Argentina.'}, {'ForeName': 'Carla C', 'Initials': 'CC', 'LastName': 'Brovia', 'Affiliation': 'Division of Respiratory Care and Physical Therapy, Hospital Donación Francisco Santojanni, Buenos Aires, Argentina.'}, {'ForeName': 'María C', 'Initials': 'MC', 'LastName': 'Pita', 'Affiliation': 'Division of Respiratory Care and Physical Therapy, Hospital Donación Francisco Santojanni, Buenos Aires, Argentina.'}, {'ForeName': 'María P', 'Initials': 'MP', 'LastName': 'Pedace', 'Affiliation': 'Division of Respiratory Care and Physical Therapy, Hospital Donación Francisco Santojanni, Buenos Aires, Argentina.'}, {'ForeName': 'María F', 'Initials': 'MF', 'LastName': 'De Benedetto', 'Affiliation': 'Division of Respiratory Care and Physical Therapy, Hospital Donación Francisco Santojanni, Buenos Aires, Argentina.'}, {'ForeName': 'Julieta', 'Initials': 'J', 'LastName': 'Delli Carpini', 'Affiliation': 'Division of Respiratory Care and Physical Therapy, Hospital Donación Francisco Santojanni, Buenos Aires, Argentina.'}, {'ForeName': 'Patricio', 'Initials': 'P', 'LastName': 'Aguirre', 'Affiliation': 'Division of Respiratory Care and Physical Therapy, Hospital Donación Francisco Santojanni, Buenos Aires, Argentina.'}, {'ForeName': 'Gisela', 'Initials': 'G', 'LastName': 'Montero', 'Affiliation': 'Division of Respiratory Care and Physical Therapy, Hospital Donación Francisco Santojanni, Buenos Aires, Argentina.'}]",Respiratory care,['10.4187/respcare.06541'] 1256,31602370,B-Mode Ultrasonography versus Contrast-Enhanced Ultrasonography for Surveillance of Hepatocellular Carcinoma: A Prospective Multicenter Randomized Controlled Trial.,"Background Current practice guidelines recommend the use of ultrasound (US) as an initial surveillance tool for hepatocellular carcinoma (HCC) in patients with liver cirrhosis. Patients with liver cirrhosis, however, frequently have coarse liver parenchyma, masking the presence of tiny nodules during B-mode US. Contrast-enhanced US (CEUS) with Sonazoid has a long-lasting, stable Kupffer phase, which makes it possible to scan the entire liver to depict small lesions. In addition, defect reperfusion imaging (reinjection imaging) enables to determine whether the detected nodule is HCC or not. This prospective, multicenter, randomized, controlled trial was conducted to demonstrate the usefulness of Kupffer phase surveillance in the detection of small HCC compared to B-mode US. Methods A total of 23 institutions joined this study. In total, 656 patients with hepatitis B- or C-related liver cirrhosis were randomized either to the B-mode US surveillance group ( n = 313) or the Kupffer phase CEUS with Sonazoid surveillance group ( n = 309). The primary endpoint was the maximum size of HCC at the time of the first detection. Secondary endpoints included time to HCC detection, number of tumors, and Barcelona Clinic Liver Cancer stage at the first detection, and sensitivity, specificity, and accuracy of each method in the diagnosis, and the cumulative detection rate of HCC. Results The mean HCC size at the first detection was significantly smaller in the CEUS (13.0 ± 4.1 mm; n = 28) than in the B-mode US group (16.7 ± 4.1 mm; n = 26) (p = 0.011). Of the 38 patients with HCV cirrhosis diagnosed with HCC by US alone, mean tumor size at the first detection was significantly smaller in the 20 patients diagnosed by CEUS alone than in the 18 diagnosed by B-mode US alone (12.7 ± 3.1 vs. 17.6 ± 7.0 mm, p = 0.012). In contrast, among the 16 patients with HBV cirrhosis diagnosed by US alone, mean tumor size at the first detection was similar in the 8 patients diagnosed by CEUS alone and the 8 diagnosed by B-mode US (13.6 ± 6.0 vs. 14.5 ± 2.7 mm, p = 0.715). Conclusion Kupffer phase CEUS surveillance with Sonazoid is extremely useful for the early detection and confirmation of HCC using a reinjection technique. Kupffer phase CEUS with Sonazoid contrast combined with the reinjection technique is, therefore, recommended as first-line screening tool for HCC in patients with liver cirrhosis, especially those with very coarse liver parenchyma.",2019,The mean HCC size at the first detection was significantly smaller in the CEUS (13.0 ± 4.1 mm; n = 28) than in the B-mode US group (16.7 ± 4.1 mm; n = 26) (p = 0.011).,"['patients with liver cirrhosis, especially those with very coarse liver parenchyma', '16 patients with HBV cirrhosis', '656 patients with hepatitis B- or C-related liver cirrhosis', 'patients with liver cirrhosis', 'Patients with liver cirrhosis', '38 patients with HCV cirrhosis diagnosed with HCC', 'Hepatocellular Carcinoma']","['B-Mode Ultrasonography versus Contrast-Enhanced Ultrasonography', 'Kupffer phase CEUS with Sonazoid surveillance', 'Contrast-enhanced US (CEUS) with Sonazoid']","['mean tumor size', 'mean HCC size', 'time to HCC detection, number of tumors, and Barcelona Clinic Liver Cancer stage at the first detection, and sensitivity, specificity, and accuracy of each method in the diagnosis, and the cumulative detection rate of HCC', 'maximum size of HCC at the time of the first detection']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0023890', 'cui_str': 'Hepatic Cirrhosis'}, {'cui': 'C0205194', 'cui_str': 'Coarse (qualifier value)'}, {'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C1623038', 'cui_str': 'Cirrhosis'}, {'cui': 'C0019163', 'cui_str': 'Hepatitis B Virus Infection'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C2239176', 'cui_str': 'Liver Cell Carcinoma, Adult'}]","[{'cui': 'C0041618', 'cui_str': 'Echotomography'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C3252337', 'cui_str': 'Sonazoid'}, {'cui': 'C0733511', 'cui_str': 'Surveillance (regime/therapy)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0475440', 'cui_str': 'Tumor size'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0475450', 'cui_str': 'Number of tumors (observable entity)'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0345904', 'cui_str': 'Cancer of Liver'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0037791', 'cui_str': 'Specificity'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}]",656.0,0.0305873,The mean HCC size at the first detection was significantly smaller in the CEUS (13.0 ± 4.1 mm; n = 28) than in the B-mode US group (16.7 ± 4.1 mm; n = 26) (p = 0.011).,"[{'ForeName': 'Masatoshi', 'Initials': 'M', 'LastName': 'Kudo', 'Affiliation': 'Department of Gastroenterology and Hepatology, Kindai University School of Medicine, Osaka, Japan.'}, {'ForeName': 'Kazuomi', 'Initials': 'K', 'LastName': 'Ueshima', 'Affiliation': 'Department of Gastroenterology and Hepatology, Kindai University School of Medicine, Osaka, Japan.'}, {'ForeName': 'Yukio', 'Initials': 'Y', 'LastName': 'Osaki', 'Affiliation': 'Department of Gastroenterology and Hepatology, Osaka Red Cross Hospital, Osaka, Japan.'}, {'ForeName': 'Masashi', 'Initials': 'M', 'LastName': 'Hirooka', 'Affiliation': 'Department of Gastroenterology and Metabology, Ehime University Graduate School of Medicine, Ehime, Japan.'}, {'ForeName': 'Yasuharu', 'Initials': 'Y', 'LastName': 'Imai', 'Affiliation': 'Department of Gastroenterology, Ikeda Municipal Hospital, Osaka, Japan.'}, {'ForeName': 'Kazunobu', 'Initials': 'K', 'LastName': 'Aso', 'Affiliation': 'Division of Metabolism and Biosystemic Science, Department of Internal Medicine, Asahikawa Medical College, Asahikawa, Japan.'}, {'ForeName': 'Kazushi', 'Initials': 'K', 'LastName': 'Numata', 'Affiliation': 'Gastroenterological Center, Yokohama City University Medical Center, Yokohama, Japan.'}, {'ForeName': 'Masayuki', 'Initials': 'M', 'LastName': 'Kitano', 'Affiliation': 'Second Department of Internal Medicine, Wakayama Medical University, Wakayama, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Kumada', 'Affiliation': 'Department of Gastroenterology and Hepatology, Ogaki Municipal Hospital, Ogaki, Japan.'}, {'ForeName': 'Namiki', 'Initials': 'N', 'LastName': 'Izumi', 'Affiliation': 'Department of Gastroenterology and Hepatology, Musashino Red Cross Hospital, Musashino, Japan.'}, {'ForeName': 'Yasukiyo', 'Initials': 'Y', 'LastName': 'Sumino', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal Medicine, Toho University Medical Center, Tokyo, Japan.'}, {'ForeName': 'Chikara', 'Initials': 'C', 'LastName': 'Ogawa', 'Affiliation': 'Department of Gastroenterology and Hepatology, Takamatsu Red Cross Hospital, Takamatsu, Japan.'}, {'ForeName': 'Kohei', 'Initials': 'K', 'LastName': 'Akazawa', 'Affiliation': 'Department of Medical Informatics, Niigata University Medical and Dental Hospital, Niigata City, Japan.'}]",Liver cancer,['10.1159/000501082'] 1257,31619184,A randomized controlled efficacy study of the Medido medication dispenser in Parkinson's disease.,"BACKGROUND Complex medication schedules in Parkinson's disease (PD) result in lower therapy adherence, which contributes to suboptimal therapy and clinical deterioration. Medication reminder systems might improve therapy adherence and subsequently improve symptoms of PD. This randomized controlled study assessed the effect of the electronic medication dispenser Medido on physical disability in PD, as a proxy for changes in therapy adherence.x METHODS: Eighty-seven patients were randomized into the Medido group or control group. The primary outcome of physical disability was measured by the AMC Linear Disability Scale (ALDS). Secondary outcomes were quality of life (QoL) (PDQ-39), health status (EQ5D-5L, VAS), non-motor symptoms (NMS-Quest), and QoL of the caregiver (PDQ-carer). Measurements were performed at baseline, and after 3 and 6 months follow-up. RESULTS When using the Medido, a non-significant improvement of 3.0 points (95% CI -5.6;11.6) was seen in ALDS. The exploratory subgroup Hoehn & Yahr classification (H&Y) > 2.5 improved significantly on ALDS with 14.7 points (95% CI -28.5;-0.9, p = 0.029 for group x time interaction). QoL deteriorated with 1.0 point in PDQ-39 (p = 0.01 for group x time interaction) in favor of the control group. Non-significant differences were observed for VAS (0.4 points, p = 0.057) and NMS-Quest (1.3 points, p = 0.095) in favor of the Medido group. No changes over time were observed in EQ5D-5L and PDQ-carer. CONCLUSIONS Based on these data, no firm conclusion can be drawn, but use of the Medido medication dispenser may result in a clinical improvement of physical disability and seems particularly appropriate for more severe patients. TRIAL REGISTRATION NTR3917 . Registered 19 March 2013.",2019,QoL deteriorated with 1.0 point in PDQ-39 (p = 0.01 for group,"[' Eighty-seven patients', ""Parkinson's disease"", ""Parkinson's disease (PD""]","['Medido medication dispenser', 'Medido group or control group', 'electronic medication dispenser Medido']","['physical disability', 'EQ5D-5L and PDQ-carer', 'quality of life (QoL) (PDQ-39), health status (EQ5D-5L, VAS), non-motor symptoms (NMS-Quest), and QoL of the caregiver (PDQ-carer', 'AMC Linear Disability Scale (ALDS', 'therapy adherence', 'VAS']","[{'cui': 'C4517895', 'cui_str': 'Eighty-seven'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0030567', 'cui_str': 'Idiopathic Parkinson Disease'}]","[{'cui': 'C0180463', 'cui_str': 'Dispenser'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4281784', 'cui_str': 'Electronics'}]","[{'cui': 'C0520817', 'cui_str': 'Physical handicap (finding)'}, {'cui': 'C1305660', 'cui_str': 'Carer (occupation)'}, {'cui': 'C0034380'}, {'cui': 'C0018759', 'cui_str': 'Level of Health'}, {'cui': 'C0426980', 'cui_str': 'Motor symptoms (finding)'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0382121', 'cui_str': '(3H)-AMC'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0222045'}, {'cui': 'C0330318', 'cui_str': 'Alder'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]",87.0,0.0838715,QoL deteriorated with 1.0 point in PDQ-39 (p = 0.01 for group,"[{'ForeName': 'K', 'Initials': 'K', 'LastName': 'Hannink', 'Affiliation': 'Department of Neurology, Medisch Spectrum Twente, Koningsplein 1, 7512 KZ, Enschede, the Netherlands.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Ter Brake', 'Affiliation': 'Department of Neurology, Ziekenhuis Groep Twente, Almelo, the Netherlands.'}, {'ForeName': 'N G M', 'Initials': 'NGM', 'LastName': 'Oonk', 'Affiliation': 'Department of Neurology, Medisch Spectrum Twente, Koningsplein 1, 7512 KZ, Enschede, the Netherlands.'}, {'ForeName': 'A A', 'Initials': 'AA', 'LastName': 'Wertenbroek', 'Affiliation': 'Department of Neurology, Ziekenhuis Groep Twente, Almelo, the Netherlands.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Piek', 'Affiliation': 'Department of Neurology, Medisch Spectrum Twente, Koningsplein 1, 7512 KZ, Enschede, the Netherlands.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Vree-Egberts', 'Affiliation': 'Department of Neurology, Medisch Spectrum Twente, Koningsplein 1, 7512 KZ, Enschede, the Netherlands.'}, {'ForeName': 'M J', 'Initials': 'MJ', 'LastName': 'Faber', 'Affiliation': 'Radboud Institute for Health Sciences, Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'van der Palen', 'Affiliation': 'Department of Epidemiology, Medisch Spectrum Twente, Enschede, the Netherlands.'}, {'ForeName': 'L D', 'Initials': 'LD', 'LastName': 'Dorresteijn', 'Affiliation': 'Department of Neurology, Medisch Spectrum Twente, Koningsplein 1, 7512 KZ, Enschede, the Netherlands. l.dorresteijn@mst.nl.'}]",BMC geriatrics,['10.1186/s12877-019-1292-y'] 1258,29779435,Class Percentage of Students With Reading Difficulties on Content Knowledge and Comprehension.,"We examined the efficacy of a content acquisition and reading comprehension intervention implemented in eighth-grade social studies classrooms. Using a within-teacher randomized control design, 18 eighth-grade teachers' social studies classes were randomly assigned to a treatment or comparison condition. Teachers taught all their classes (treatment and comparison) using the same content; however, in the treatment classes, teachers used instructional practices that included comprehension canopy, essential words, knowledge acquisition, and team-based learning. Students with reading comprehension difficulties in the treatment classes ( n  = 359) outperformed students with reading comprehension difficulties in the comparison classes ( n  = 331) on measures of content knowledge acquisition and content reading comprehension but not general reading comprehension. In addition, the proportion of students with reading comprehension difficulties in classes moderated outcomes for content knowledge acquisition and content reading comprehension.",2019,Students with reading comprehension difficulties in the treatment classes ( n = 359) outperformed students with reading comprehension difficulties in the comparison classes ( n = 331) on measures of content knowledge acquisition and content reading comprehension but not general reading comprehension.,"[""18 eighth-grade teachers' social studies classes"", 'eighth-grade social studies classrooms', 'Students with reading comprehension difficulties in the treatment classes ( n\u2009= 359) outperformed students with reading comprehension difficulties in the comparison classes ( n\u2009= 331']",['content acquisition and reading comprehension intervention'],['content knowledge acquisition and content reading comprehension'],"[{'cui': 'C0205442', 'cui_str': 'Eighth (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0221457', 'cui_str': 'Teacher (occupation)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0456387', 'cui_str': 'Classes (qualifier value)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}]","[{'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C0022750', 'cui_str': 'Knowledge Acquisition (Computer)'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}]",359.0,0.0160682,Students with reading comprehension difficulties in the treatment classes ( n = 359) outperformed students with reading comprehension difficulties in the comparison classes ( n = 331) on measures of content knowledge acquisition and content reading comprehension but not general reading comprehension.,"[{'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Vaughn', 'Affiliation': 'University of Texas at Austin, Austin, TX, USA.'}, {'ForeName': 'Anna-Mária', 'Initials': 'AM', 'LastName': 'Fall', 'Affiliation': 'University of Texas at Austin, Austin, TX, USA.'}, {'ForeName': 'Greg', 'Initials': 'G', 'LastName': 'Roberts', 'Affiliation': 'University of Texas at Austin, Austin, TX, USA.'}, {'ForeName': 'Jeanne', 'Initials': 'J', 'LastName': 'Wanzek', 'Affiliation': 'Vanderbilt University, Nashville, TN, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Swanson', 'Affiliation': 'University of Texas at Austin, Austin, TX, USA.'}, {'ForeName': 'Leticia R', 'Initials': 'LR', 'LastName': 'Martinez', 'Affiliation': 'University of Texas at Austin, Austin, TX, USA.'}]",Journal of learning disabilities,['10.1177/0022219418775117'] 1259,31557763,Benefit and Risks of Aspirin in Addition to Ticagrelor in Acute Coronary Syndromes: A Post Hoc Analysis of the Randomized GLOBAL LEADERS Trial.,"Importance The role of aspirin as part of antiplatelet regimens in acute coronary syndromes (ACS) needs to be clarified in the context of newer potent P2Y12 antagonists. Objective To evaluate the benefit and risks of aspirin in addition to ticagrelor among patients with ACS beyond 1 month after percutaneous coronary intervention (PCI). Design, Setting, and Participants This is a nonprespecified, post hoc analysis of GLOBAL LEADERS, a randomized, open-label superiority trial comparing 2 antiplatelet treatment strategies after PCI. The trial included 130 secondary/tertiary care hospitals in different countries, with 15 991 unselected patients with stable coronary artery disease or ACS undergoing PCI. Patients had outpatient visits at 1, 3, 6, 12, 18, and 24 months after index procedure. Interventions The experimental group received aspirin plus ticagrelor for 1 month followed by 23-month ticagrelor monotherapy; the reference group received aspirin plus either clopidogrel (stable coronary artery disease) or ticagrelor (ACS) for 12 months, followed by 12-month aspirin monotherapy. In this analysis, we examined the clinical outcomes occurring between 31 days and 365 days after randomization, specifically in patients with ACS who, within this time frame, were assigned to receive either ticagrelor alone or ticagrelor and aspirin. Main Outcomes and Measures The primary outcome was the composite of all-cause death or new Q-wave myocardial infarction. Results Of 15 968 participants, there were 7487 patients with ACS enrolled; 3750 patients were assigned to the experimental group and 3737 patients to the reference group. Between 31 and 365 days after randomization, the primary outcome occurred in 55 patients (1.5%) in the experimental group and in 75 patients (2.0%) in the reference group (hazard ratio [HR], 0.73; 95% CI, 0.51-1.03; P = .07); investigator-reported Bleeding Academic Research Consortium-defined bleeding type 3 or 5 occurred in 28 patients (0.8%) in the experimental group and in 54 patients (1.5%) in the reference arm (HR, 0.52; 95% CI, 0.33-0.81; P = .004). Conclusions and Relevance Between 1 month and 12 months after PCI in ACS, aspirin was associated with increased bleeding risk and appeared not to add to the benefit of ticagrelor on ischemic events. These findings should be interpreted as exploratory and hypothesis generating; however, they pave the way for further trials evaluating aspirin-free antiplatelet strategies after PCI. Trial Registration ClinicalTrials.gov identifier: NCT01813435.",2019,"This is a nonprespecified, post hoc analysis of GLOBAL LEADERS, a randomized, open-label superiority trial comparing 2 antiplatelet treatment strategies after PCI.","['acute coronary syndromes (ACS', '968 participants', 'patients with ACS who, within this time frame', 'Acute Coronary Syndromes', 'Patients had outpatient visits at 1, 3, 6, 12, 18, and 24 months after index procedure', '7487 patients with ACS enrolled; 3750 patients were assigned to the experimental group and 3737 patients to the reference group', '130 secondary/tertiary care hospitals in different countries, with 15\u202f991 unselected patients with stable coronary artery disease or ACS undergoing PCI', 'patients with ACS beyond 1 month after percutaneous coronary intervention (PCI']","['Aspirin', 'Ticagrelor', 'ticagrelor alone or ticagrelor and aspirin', 'aspirin plus ticagrelor', 'aspirin plus either clopidogrel (stable coronary artery disease) or ticagrelor (ACS', 'aspirin', 'ticagrelor', 'aspirin monotherapy']","['composite of all-cause death or new Q-wave myocardial infarction', 'bleeding risk']","[{'cui': 'C0948089', 'cui_str': 'Acute Coronary Syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332168', 'cui_str': 'Time frame'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C4517746', 'cui_str': '3750'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4319552', 'cui_str': '130 (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0337954', 'cui_str': 'Tertiary care hospital (environment)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}]","[{'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}, {'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}]","[{'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C1305738', 'cui_str': 'Q wave feature'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",130.0,0.0780479,"This is a nonprespecified, post hoc analysis of GLOBAL LEADERS, a randomized, open-label superiority trial comparing 2 antiplatelet treatment strategies after PCI.","[{'ForeName': 'Mariusz', 'Initials': 'M', 'LastName': 'Tomaniak', 'Affiliation': 'Department of Cardiology, Erasmus Medical Center, Erasmus University, Rotterdam, the Netherlands.'}, {'ForeName': 'Ply', 'Initials': 'P', 'LastName': 'Chichareon', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Yoshinobu', 'Initials': 'Y', 'LastName': 'Onuma', 'Affiliation': 'Department of Cardiology, Erasmus Medical Center, Erasmus University, Rotterdam, the Netherlands.'}, {'ForeName': 'Efthymios N', 'Initials': 'EN', 'LastName': 'Deliargyris', 'Affiliation': 'PLx Pharma Inc, Sparta, New Jersey.'}, {'ForeName': 'Kuniaki', 'Initials': 'K', 'LastName': 'Takahashi', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Norihiro', 'Initials': 'N', 'LastName': 'Kogame', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Modolo', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Chun Ching', 'Initials': 'CC', 'LastName': 'Chang', 'Affiliation': 'Department of Cardiology, Erasmus Medical Center, Erasmus University, Rotterdam, the Netherlands.'}, {'ForeName': 'Tessa', 'Initials': 'T', 'LastName': 'Rademaker-Havinga', 'Affiliation': 'Cardialysis Core Laboratories and Clinical Trial Management, Rotterdam, the Netherlands.'}, {'ForeName': 'Robert F', 'Initials': 'RF', 'LastName': 'Storey', 'Affiliation': 'Department of Infection, Immunity and Cardiovascular Disease, University of Sheffield, Sheffield, England.'}, {'ForeName': 'George D', 'Initials': 'GD', 'LastName': 'Dangas', 'Affiliation': 'Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Deepak L', 'Initials': 'DL', 'LastName': 'Bhatt', 'Affiliation': ""Department of Medicine, Brigham and Women's Hospital Heart and Vascular Center, Boston, Massachusetts.""}, {'ForeName': 'Dominick J', 'Initials': 'DJ', 'LastName': 'Angiolillo', 'Affiliation': 'Division of Cardiology, University of Florida, College of Medicine, Jacksonville.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Hamm', 'Affiliation': 'University of Giessen, Giessen, Germany.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Valgimigli', 'Affiliation': 'Department of Cardiology, Bern University Hospital, Inselspital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Windecker', 'Affiliation': 'Department of Cardiology, Bern University Hospital, Inselspital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Philippe Gabriel', 'Initials': 'PG', 'LastName': 'Steg', 'Affiliation': 'French Alliance for Cardiovascular Trials, Université Paris Diderot, Hôpital Bichat, Assistance Publique Hôpitaux de Paris, and INSERM U-1148, Paris, France.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Vranckx', 'Affiliation': 'Department of Cardiology and Critical Care Medicine, Hartcentrum Hasselt, Jessa Ziekenhuis, Hasselt, Belgium.'}, {'ForeName': 'Patrick W', 'Initials': 'PW', 'LastName': 'Serruys', 'Affiliation': 'National Heart and Lung Institute, Imperial College London, London, England.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA cardiology,['10.1001/jamacardio.2019.3355'] 1260,31872152,Suubi+Adherence study protocol: A family economic empowerment intervention addressing HIV treatment adherence for perinatally infected adolescents.,"Background Globally, 1.8 million children<15 years are living with HIV. Sub-Saharan Africa (SSA), as a region, is heavily burdened by HIV, with 90% of new infections among children happening there. Within SSA, Uganda has an HIV prevalence of 7.2% among 15-49-year-olds, with high prevalence in Masaka region (12%). Uganda also reports unprecedented numbers of perinatally HIV-infected children, with close to 150,000 children (ages 0-14) living with HIV (CLHA). However adherence to antiretroviral therapy (ART) among children and youth is poor, and has been attributed to economic insecurity, including lack of finances for transportation to clinic appointments, inadequate meals to support medication consumption, and resource prioritization towards school expenses. Yet, few programs aimed at addressing ART adherence have applied combination interventions to address economic stability and ART Adherence within the traditional framework of health education and HIV care. This paper describes a study protocol for a 5-year, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) funded, cluster randomized-controlled trial to evaluate a combination intervention, titled Suubi + Adherence, aimed at improving ART adherence among HIV perinatally infected adolescents (ages 10-16 at study enrollment) in Uganda. Methods Suubi + Adherence was evaluated via a two-arm cluster randomized-controlled trial design in 39 health clinics, with a total enrollment of 702 HIV + adolescents (ages 10-16 at enrollment). The study addresses two primary outcomes: 1) adherence to HIV treatment regimen and 2) HIV knowledge and attitudes. Secondary outcomes include family functioning, sexual risk-taking behavior, and financial savings behavior. For potential scale-up, cost effectiveness analysis was employed to compare the relative costs and outcomes associated with each study arm: family economic strengthening comprising matched savings accounts, financial management training and small business development, all intended for family economic security versus bolstered usual care (SOC) comprising enhanced adherence sessions to ensure more standardized and sufficient adherence counseling. Discussion This study aims to advance knowledge and inform the development of the next generation of programs aimed at increasing adherence to HIV treatment for HIV + adolescents in low-resource regions such as SSA. To our knowledge, the proposed study is the first to integrate and test family economic empowerment and stability-focused interventions for HIV + adolescents in Uganda (and much of SSA)-so families would have the necessary finances to manage HIV/AIDS as a chronic illness. The study would provide crucial evidence about the effects of an economic empowerment program on short and long-term impact, which is essential if such interventions are to be taken to scale. Trial registration This trial was registered with ClinicalTrials.gov (registration number: NCT01790373) on 13 February 2013.",2019,This study aims to advance knowledge and inform the development of the next generation of programs aimed at increasing adherence to HIV treatment for HIV + adolescents in low-resource regions such as SSA.,"['39 health clinics, with a total enrollment of 702 HIV\xa0+\xa0adolescents (ages 10-16\xa0at enrollment', 'HIV perinatally infected adolescents (ages 10-16\xa0at study enrollment) in Uganda', 'a 5-year, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD', 'perinatally HIV-infected children, with close to 150,000 children (ages 0-14) living with HIV (CLHA', 'perinatally infected adolescents']","['economic empowerment program', 'combination intervention, titled Suubi\xa0+\xa0Adherence', 'family economic empowerment intervention addressing HIV treatment adherence', 'financial management training and small business development, all intended for family economic security versus bolstered usual care (SOC', 'antiretroviral therapy (ART']","['family functioning, sexual risk-taking behavior, and financial savings behavior', 'adherence to HIV treatment regimen and 2) HIV knowledge and attitudes']","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0041573', 'cui_str': 'Republic of Uganda'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1513896', 'cui_str': 'National Institute of Child Health and Human Development'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0587267', 'cui_str': 'Closed (qualifier value)'}, {'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}]","[{'cui': 'C0013557', 'cui_str': 'economics'}, {'cui': 'C0679959', 'cui_str': 'Empowerment'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0376649', 'cui_str': 'Address'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C4505265', 'cui_str': 'Treatment Adherence'}, {'cui': 'C0220830', 'cui_str': 'financial management'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C2936313', 'cui_str': 'Microenterprise'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0003826', 'cui_str': 'Arts'}]","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0035651', 'cui_str': 'Risk-Taking'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}]",702.0,0.0954943,This study aims to advance knowledge and inform the development of the next generation of programs aimed at increasing adherence to HIV treatment for HIV + adolescents in low-resource regions such as SSA.,"[{'ForeName': 'Fred M', 'Initials': 'FM', 'LastName': 'Ssewamala', 'Affiliation': 'Washington University in St. Louis, Brown School, Campus Box 1196, One Brookings Drive, St. Louis, MO, 63130, United States.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Byansi', 'Affiliation': 'Washington University in St. Louis, MO, United States.'}, {'ForeName': 'Ozge Sensoy', 'Initials': 'OS', 'LastName': 'Bahar', 'Affiliation': 'Washington University in St. Louis, MO, United States.'}, {'ForeName': 'Proscovia', 'Initials': 'P', 'LastName': 'Nabunya', 'Affiliation': 'Washington University in St. Louis, MO, United States.'}, {'ForeName': 'Torsten B', 'Initials': 'TB', 'LastName': 'Neilands', 'Affiliation': 'University of California San Francisco, United States.'}, {'ForeName': 'Claude', 'Initials': 'C', 'LastName': 'Mellins', 'Affiliation': 'Columbia University Medical Center, United States.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'McKay', 'Affiliation': 'Washington University in St. Louis, MO, United States.'}, {'ForeName': 'Flavia', 'Initials': 'F', 'LastName': 'Namuwonge', 'Affiliation': 'International Center for Child Health and Development, Masaka, Uganda.'}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Mukasa', 'Affiliation': 'International Center for Child Health and Development, Masaka, Uganda.'}, {'ForeName': 'Fredrick Edward', 'Initials': 'FE', 'LastName': 'Makumbi', 'Affiliation': 'Makerere University, Kampala, Uganda.'}, {'ForeName': 'Gertrude', 'Initials': 'G', 'LastName': 'Nakigozi', 'Affiliation': 'Rakai Health Sciences Program, Rakai, Uganda.'}]",Contemporary clinical trials communications,['10.1016/j.conctc.2019.100463'] 1261,31648204,Multimodal Training Reduces Fall Frequency as Physical Activity Increases in Individuals With Parkinson's Disease.,"BACKGROUND Parkinson's disease (PD) results in a global decrease in information processing, ultimately resulting in dysfunction executing motor-cognitive tasks. Motor-cognitive impairments contribute to postural instability, often leading to falls and decreased physical activity. The aim of this study was to determine the effects of a multimodal training (MMT) versus single-modal (SMT) training on motor symptoms, fall frequency, and physical activity in patients with PD classified as fallers. METHODS Individuals with PD were randomized into SMT (n = 11) or MMT (n = 10) and completed training 3 times per week for 8 weeks. The SMT completed gait and cognitive training separately, whereas MMT completed gait and cognitive training simultaneously during each 45-minute session. Physical activity, 30-day fall frequency, and PD motor symptoms were assessed at baseline, posttreatment, and during a 4-week follow-up. RESULTS Both groups exhibited significant (P < .05) improvements in clinical ratings of motor function, as symptoms improved by 8% and 15% for SMT and MMT, respectively. Physical activity significantly increased (P < .05) for both groups from baseline (mean steps 4942 [4415]) to posttreatment (mean steps 5914 [5425]). The MMT resulted in a significant 60% reduction in falls. CONCLUSIONS Although SMT and MMT approaches are both effective in improving physical activity and motor symptoms of PD, only MMT reduced fall frequency after the intervention.",2019,Physical activity significantly increased (P < .05) for both groups from baseline (mean steps 4942 [4415]) to posttreatment (mean steps 5914 [5425]).,"[""Individuals With Parkinson's Disease"", 'patients with PD classified as fallers', 'Individuals with PD']","['multimodal training (MMT) versus single-modal (SMT) training', 'MMT', 'Multimodal Training', 'SMT']","['clinical ratings of motor function', 'falls', 'physical activity and motor symptoms of PD', 'motor symptoms, fall frequency, and physical activity', 'Physical activity', 'Physical activity, 30-day fall frequency, and PD motor symptoms']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0030567', 'cui_str': 'Idiopathic Parkinson Disease'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0008902', 'cui_str': 'Systematics'}]","[{'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0046370', 'cui_str': 'MMT'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0234130', 'cui_str': 'Motor function (observable entity)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0426980', 'cui_str': 'Motor symptoms (finding)'}, {'cui': 'C0000921', 'cui_str': 'Falls'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]",,0.0165732,Physical activity significantly increased (P < .05) for both groups from baseline (mean steps 4942 [4415]) to posttreatment (mean steps 5914 [5425]).,"[{'ForeName': 'Amanda L', 'Initials': 'AL', 'LastName': 'Penko', 'Affiliation': ''}, {'ForeName': 'Jacob E', 'Initials': 'JE', 'LastName': 'Barkley', 'Affiliation': ''}, {'ForeName': 'Anson B', 'Initials': 'AB', 'LastName': 'Rosenfeldt', 'Affiliation': ''}, {'ForeName': 'Jay L', 'Initials': 'JL', 'LastName': 'Alberts', 'Affiliation': ''}]",Journal of physical activity & health,['10.1123/jpah.2018-0595'] 1262,29992432,Effectiveness of Health Belief Model on Oral Cancer Prevention in Smoker Men.,"The purpose of the present study is investigating the effect of educational intervention based on health belief model (HBM) on oral cancer prevention in smoker men. This is a quasi-experimental study carried out on 200 smoker men with the age of 40 or older (100 subjects for the experimental group and 100 subjects for control group) resident in Fasa City, Fars Province, Iran, in 2017-2018. The educational intervention for the experimental group included seven educational sessions for 50 or 55 min-based HBM. A questionnaire consisted of items about demographic information, knowledge, HBM constructs (perceived susceptibility, severity, benefits, barriers, self-efficacy, and cues to action) was used to measure the oral cancer prevention before and 6 months after the intervention. The mean age of the men was 51.35±8.41 years in the experimental group and 52.28±8.09 years in the control group. Based on the obtained results, significant enhancement is observed in average scores of knowledge, perceived susceptibility, severity, benefits, self-efficacy, cues to action, and oral cancer prevention behaviors in experimental group; however, no significant changes are observed in average scores of knowledge, perceived susceptibility, severity, benefits, self-efficacy, cues to action, and oral cancer prevention behaviors of control group. Also, results indicated that, the educational program based on HBM model have positive effect on oral cancer prevention with the improvement of subject's knowledge, perceived susceptibility, severity, benefits, and self-efficacy.",2019,"Based on the obtained results, significant enhancement is observed in average scores of knowledge, perceived susceptibility, severity, benefits, self-efficacy, cues to action, and oral cancer prevention behaviors in experimental group; however, no significant changes are observed in average scores of knowledge, perceived susceptibility, severity, benefits, self-efficacy, cues to action, and oral cancer prevention behaviors of control group.","['Smoker Men', '200 smoker men with the age of 40 or older (100 subjects for the experimental group and 100 subjects for control group) resident in Fasa City, Fars Province, Iran, in 2017-2018', 'smoker men']","['educational intervention based on health belief model (HBM', 'Health Belief Model']","['average scores of knowledge, perceived susceptibility, severity, benefits, self-efficacy, cues to action, and oral cancer prevention behaviors', 'knowledge, HBM constructs (perceived susceptibility, severity, benefits, barriers, self-efficacy, and cues to action', ""subject's knowledge, perceived susceptibility, severity, benefits, and self-efficacy"", 'Oral Cancer Prevention']","[{'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0022065', 'cui_str': 'Islamic Republic of Iran'}]","[{'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C3714363', 'cui_str': 'Health belief model (qualifier value)'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C1264642', 'cui_str': 'Susceptibility (property) (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0441472', 'cui_str': 'Action (qualifier value)'}, {'cui': 'C0153381', 'cui_str': 'Cancer of Mouth'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}]",200.0,0.0114368,"Based on the obtained results, significant enhancement is observed in average scores of knowledge, perceived susceptibility, severity, benefits, self-efficacy, cues to action, and oral cancer prevention behaviors in experimental group; however, no significant changes are observed in average scores of knowledge, perceived susceptibility, severity, benefits, self-efficacy, cues to action, and oral cancer prevention behaviors of control group.","[{'ForeName': 'Ali Khani', 'Initials': 'AK', 'LastName': 'Jeihooni', 'Affiliation': 'Department of Public Health, School of Health, Fasa University of Medical Sciences, Fasa Ibn Sina square, Fasa, 7461686688, Iran. Khani_1512@yahoo.com.'}, {'ForeName': 'Samira Fatehi', 'Initials': 'SF', 'LastName': 'Dindarloo', 'Affiliation': 'Department of Public Health, School of Health, Fasa University of Medical Sciences, Fasa Ibn Sina square, Fasa, 7461686688, Iran.'}, {'ForeName': 'Pouyan Afzali', 'Initials': 'PA', 'LastName': 'Harsini', 'Affiliation': 'Department of Public Health, School of Health, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}]",Journal of cancer education : the official journal of the American Association for Cancer Education,['10.1007/s13187-018-1396-7'] 1263,29935326,Effect of I-scan Electronic Chromoendoscopy on Detection of Adenomas During Colonoscopy.,"BACKGROUND & AIMS I-scan is an electronic chromoendoscopy technology that improves resolution of epithelial and mucosal surfaces and vessels. We performed a randomized controlled trial to compare detection of adenomas by i-scan vs standard high-definition white-light (HDWL) colonoscopy. METHODS From February 1 through December 31, 2017, 740 outpatients (50-75 years old) undergoing screening and surveillance for colorectal neoplasia were randomly assigned to groups that received colonoscopies with i-scan 1 (surface and contrast enhancement) or HDWL. When lesions and polyps were detected, endoscopists could switch between i-scan 1 and HDWL imaging to confirm their finding; polyps were collected and analyzed by histology. The primary outcome was adenoma detection rate (ADR, proportion of subjects with at least 1 adenoma of any size); secondary outcomes included detection of sessile serrated polyps and neoplasias, along with location, size, and morphology of polyps. We performed intent to treat and per-protocol analyses (on 357 patients evaluated by i-scan and 358 evaluated by HDWL colonoscopy) to assess the primary and secondary outcomes. RESULTS There were no differences in baseline characteristics between the groups. In the intent to treat analysis, the ADR was significantly higher in the i-scan 1 group (47.2%) than in the HDWL colonoscopy group (37.7%) (P = .01). In the per-protocol analysis, the ADR in the i-scan 1 group (47.6%) was also significantly higher than in the HDWL group (37.2%) (P = .005), but this effect was not consistent among all endoscopists. There was no difference between groups in detection of sessile serrated polyps. However, the rate of neoplasia detection was significantly higher in the i-scan 1 group (56.4%) than in the than the HDWL group (46.1%) (P = .005). In secondary analyses, the increase in ADR was associated with improved detection of diminutive flat adenomas in the right colon. CONCLUSION In a prospective randomized trial, higher proportions of patients with adenomas were identified in a group that underwent colonoscopy with i-scan 1 than in a group evaluated by HDWL colonoscopy. This effect was mainly due to improved detection of diminutive, flat right sided adenomas. I-scan 1 technology may benefit some endoscopists. ClinicalTrials.gov no: NCT02811419.",2019,"In secondary analyses, the increase in ADR was associated with improved detection of diminutive flat adenomas in the right colon. ","['patients with adenomas', 'From February 1 through December 31, 2017, 740 outpatients (50-75 years old) undergoing screening and surveillance for colorectal neoplasia']","['colonoscopies with i-scan 1 (surface and contrast enhancement) or HDWL', 'I-scan Electronic Chromoendoscopy', 'adenomas by i-scan vs standard high-definition white-light (HDWL) colonoscopy', 'colonoscopy with i-scan 1 than in a group evaluated by HDWL colonoscopy']","['ADR', 'detection of diminutive flat adenomas', 'rate of neoplasia detection', 'adenoma detection rate (ADR, proportion of subjects with at least 1 adenoma of any size); secondary outcomes included detection of sessile serrated polyps and neoplasias, along with location, size, and morphology of polyps']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001430', 'cui_str': 'Adenoma'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0733511', 'cui_str': 'Surveillance (regime/therapy)'}, {'cui': 'C0555952', 'cui_str': 'Colorectal (qualifier value)'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}]","[{'cui': 'C0009378', 'cui_str': 'Endoscopy of colon'}, {'cui': 'C0441633'}, {'cui': 'C0205148', 'cui_str': 'Surface (attribute)'}, {'cui': 'C1627358', 'cui_str': 'Refractive surgery enhancement'}, {'cui': 'C4281784', 'cui_str': 'Electronics'}, {'cui': 'C0001430', 'cui_str': 'Adenoma'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C3539107', 'cui_str': 'Definition (core metadata concept)'}, {'cui': 'C0563228', 'cui_str': 'White light (physical force)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0449207', 'cui_str': 'ADR (body structure)'}, {'cui': 'C1266024', 'cui_str': 'Flat adenoma'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0001430', 'cui_str': 'Adenoma'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C2732618', 'cui_str': 'Sessile serrated polyp'}, {'cui': 'C0450429', 'cui_str': 'Location (attribute)'}, {'cui': 'C0543482', 'cui_str': 'morphology'}, {'cui': 'C0032584', 'cui_str': 'Polyp (morphologic abnormality)'}]",740.0,0.120124,"In secondary analyses, the increase in ADR was associated with improved detection of diminutive flat adenomas in the right colon. ","[{'ForeName': 'Trilokesh D', 'Initials': 'TD', 'LastName': 'Kidambi', 'Affiliation': 'Division of Gastroenterology, City of Hope National Medical Center, Duarte, California.'}, {'ForeName': 'Jonathan P', 'Initials': 'JP', 'LastName': 'Terdiman', 'Affiliation': 'Division of Gastroenterology, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Najwa', 'Initials': 'N', 'LastName': 'El-Nachef', 'Affiliation': 'Division of Gastroenterology, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Aparajita', 'Initials': 'A', 'LastName': 'Singh', 'Affiliation': 'Division of Gastroenterology, University of California, San Francisco, San Francisco, California.'}, {'ForeName': 'Michael G', 'Initials': 'MG', 'LastName': 'Kattah', 'Affiliation': 'Division of Research, Kaiser Permanente, Oakland, California.'}, {'ForeName': 'Jeffrey K', 'Initials': 'JK', 'LastName': 'Lee', 'Affiliation': 'Division of Research, Kaiser Permanente, Oakland, California; Department of Gastroenterology, Kaiser Permanente San Francisco Medical Center, San Francisco, California. Electronic address: jeffrey.k.lee@kp.org.'}]",Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association,['10.1016/j.cgh.2018.06.024'] 1264,31933020,A Behavioral Adherence Intervention Improves Rates of Viral Suppression Among Adherence-Challenged People Living with HIV in South India.,"The success of antiretroviral therapy (ART) has led to both extended life expectancy and improved quality of life among people living with HIV (PLWH). To maximize the efficacy of first line ART regimens in low- and middle-income countries (LMIC), we need culturally-relevant interventions that empower participants to reduce barriers to long-term uninterrupted adherence. The Chetana adherence intervention trial was designed in collaboration with local community groups as a comprehensive wellness program for adherence-challenged PLWH and included peer-led adherence support, yoga, nutrition, information about local resources, and individual counseling using motivational interviewing techniques. Intervention arm participants were almost twice as likely to be virally suppressed at their 12-month follow-up visit (AOR = 1.98; 95% CI [1.2, 3.23]) as were participants in the active control arm. They were also about twice as likely as control arm participants to self-report ≥ 95% adherence (AOR = 1.86, 95% CI [1.09, 3.15]), and as having eliminated individual adherence barriers (AOR = 2.33, 95% CI [1.51, 3.62]) and clinic attendance barriers (AOR = 2.01, 95% CI [1.20, 3.38]) These low-cost strategies can be implemented by local NGOs, making it both scalable and sustainable in this and similar settings.",2020,"Intervention arm participants were almost twice as likely to be virally suppressed at their 12-month follow-up visit (AOR = 1.98; 95% CI [1.2, 3.23]) as were participants in the active control arm.","['low- and middle-income countries (LMIC', 'Living with HIV in South India', 'people living with HIV (PLWH', 'Adherence-Challenged People']","['comprehensive wellness program for adherence-challenged PLWH and included peer-led adherence support, yoga, nutrition, information about local resources, and individual counseling using motivational interviewing techniques', 'Behavioral Adherence Intervention', 'antiretroviral therapy (ART']","['quality of life', 'Viral Suppression', 'clinic attendance barriers']","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0021201', 'cui_str': 'Republic of India'}]","[{'cui': 'C0043113', 'cui_str': 'Wellness Programs'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0003826', 'cui_str': 'Arts'}]","[{'cui': 'C0034380'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression (disorder)'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}]",,0.0717147,"Intervention arm participants were almost twice as likely to be virally suppressed at their 12-month follow-up visit (AOR = 1.98; 95% CI [1.2, 3.23]) as were participants in the active control arm.","[{'ForeName': 'Maria L', 'Initials': 'ML', 'LastName': 'Ekstrand', 'Affiliation': 'Department of Medicine, Center for AIDS Prevention Studies, University of California, 550 16th Street, 3rd Floor, Box 0886, San Francisco, CA, 94143, USA. Maria.Ekstrand@ucsf.edu.'}, {'ForeName': 'Elsa', 'Initials': 'E', 'LastName': 'Heylen', 'Affiliation': 'Department of Medicine, Center for AIDS Prevention Studies, University of California, 550 16th Street, 3rd Floor, Box 0886, San Francisco, CA, 94143, USA.'}, {'ForeName': 'Matilda', 'Initials': 'M', 'LastName': 'Pereira', 'Affiliation': ""St John's Research Institute, St John's National Academy of Health Sciences, Bangalore, India.""}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': ""D'Souza"", 'Affiliation': ""St John's Research Institute, St John's National Academy of Health Sciences, Bangalore, India.""}, {'ForeName': 'Shoba', 'Initials': 'S', 'LastName': 'Nair', 'Affiliation': ""St John's Medical College and Hospital, St John's National Academy of Health Sciences, Bangalore, India.""}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Mazur', 'Affiliation': 'Department of Medicine, Center for AIDS Prevention Studies, University of California, 550 16th Street, 3rd Floor, Box 0886, San Francisco, CA, 94143, USA.'}, {'ForeName': 'Ranjani', 'Initials': 'R', 'LastName': 'Shamsundar', 'Affiliation': ""St John's Medical College and Hospital, St John's National Academy of Health Sciences, Bangalore, India.""}, {'ForeName': 'B N Ravi', 'Initials': 'BNR', 'LastName': 'Kumar', 'Affiliation': 'Karnataka State AIDS Prevention Society, Bangalore, India.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Chandy', 'Affiliation': ""St John's Medical College and Hospital, St John's National Academy of Health Sciences, Bangalore, India.""}]",AIDS and behavior,['10.1007/s10461-020-02785-6'] 1265,31553410,Effect of 1 or 2 Doses of Inclisiran on Low-Density Lipoprotein Cholesterol Levels: One-Year Follow-up of the ORION-1 Randomized Clinical Trial.,"Importance Sustained reductions in low-density lipoprotein cholesterol (LDL-C) with lipid-lowering therapies that require frequent dosing are reliant on patient adherence, and poor adherence is associated with worse clinical outcomes. Objective To determine whether inclisiran, a small interfering RNA, reduces mean LDL-C exposure with an infrequent dosing regimen. Design, Setting, and Participants Prespecified analysis of a randomized, double-blind, placebo-controlled multicenter phase 2 clinical trial. Participants were followed up monthly for LDL-C levels and proprotein convertase subtilisin-kexin type 9 (PCSK9) measurements as well as safety until their LDL-C levels had returned to within 20% of their change from baseline (maximum 360 days). The study included patients with elevated LDL-C despite maximally tolerated statin therapy. Data were analyzed between January 11, 2016, and June 7, 2017. Interventions One dose (200, 300, or 500 mg on day 1) or 2 doses (100, 200, or 300 mg on days 1 and 90) of inclisiran sodium or placebo. Main Outcomes and Measures Duration of time to return to within 20% of change from baseline for LDL-C levels and time-averaged LDL-C reductions over 1 year. Results At baseline, among the 501 participants, 65% were men (n = 326 of 501), mean age was 63 years, 6% had familial hypercholesterolemia (n = 28 of 501), and 69% had established ASCVD (n = 347 of 501). Baseline LDL-C was 128 mg/dL among 501 randomized participants. The percentage of participants who were followed up to day 360 because their LDL-C levels had not returned to within 20% of their change from baseline ranged from 48.3% to 65.0% for those receiving a single dose and between 55.9% and 83.1% of those receiving 2 doses, with similar effects observed for PCSK9. Time-averaged reduction in LDL-C levels over 1 year after a single dose ranged from 29.5% to 38.7% (P < .001 between groups) and from 29.9% to 46.4% (P < .001 between groups) for those who received 2 doses. The 2-dose 300-mg regimen produced the highest proportion of responders at day 360 and the greatest mean reduction in LDL-C over 1 year. Incidence of adverse events was similar through to 1 year. Conclusions and Relevance Treatment with inclisiran resulted in durable reductions in LDL-C over 1 year. Inclisiran may offer a novel approach to LDL-C reduction with the convenience of infrequent dosing. Trial Registration ClinicalTrials.gov identifier: NCT02597127.",2019,Time-averaged reduction in LDL-C levels over 1 year after a single dose ranged from 29.5% to 38.7% (P < .001 between groups) and from 29.9% to 46.4% (P < .001 between groups) for those who received 2 doses.,"['501 participants, 65% were men (n\u2009=\u2009326 of 501), mean age was 63 years, 6% had familial hypercholesterolemia (n\u2009=\u200928 of 501), and 69% had established ASCVD (n\u2009=\u2009347 of 501', 'patients with elevated LDL-C despite maximally tolerated statin therapy']","['placebo', 'inclisiran sodium or placebo', 'Inclisiran']","['safety until their LDL-C levels', 'Incidence of adverse events', 'low-density lipoprotein cholesterol (LDL-C', 'Measures\n\n\nDuration of time to return to within 20% of change from baseline for LDL-C levels and time-averaged LDL-C reductions', 'LDL-C levels', 'Low-Density Lipoprotein Cholesterol Levels']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0020445', 'cui_str': 'Hyperbetalipoproteinemia'}, {'cui': 'C0443211', 'cui_str': 'Established (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C1278454', 'cui_str': 'Statin prophylaxis'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4307388', 'cui_str': 'inclisiran'}, {'cui': 'C3541959', 'cui_str': 'Sodium supplement (substance)'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0332156', 'cui_str': 'Return to (contextual qualifier) (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}]",501.0,0.524868,Time-averaged reduction in LDL-C levels over 1 year after a single dose ranged from 29.5% to 38.7% (P < .001 between groups) and from 29.9% to 46.4% (P < .001 between groups) for those who received 2 doses.,"[{'ForeName': 'Kausik K', 'Initials': 'KK', 'LastName': 'Ray', 'Affiliation': 'Imperial Centre for Cardiovascular Disease Prevention, Department of Primary Care and Public Health, Imperial College London, Charing Cross Hospital, London, England.'}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Stoekenbroek', 'Affiliation': 'The Medicines Company, Parsippany, New Jersey.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Kallend', 'Affiliation': 'The Medicines Company, Parsippany, New Jersey.'}, {'ForeName': 'Toshiyuki', 'Initials': 'T', 'LastName': 'Nishikido', 'Affiliation': 'Cardiovascular Medicine, Saga University, Nabeshima, Saga, Japan.'}, {'ForeName': 'Lawrence A', 'Initials': 'LA', 'LastName': 'Leiter', 'Affiliation': 'University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Ulf', 'Initials': 'U', 'LastName': 'Landmesser', 'Affiliation': 'Charité-Universitats medizin Berlin, Berlin, Germany.'}, {'ForeName': 'R Scott', 'Initials': 'RS', 'LastName': 'Wright', 'Affiliation': 'Department of Cardiology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Peter L J', 'Initials': 'PLJ', 'LastName': 'Wijngaard', 'Affiliation': 'The Medicines Company, Parsippany, New Jersey.'}, {'ForeName': 'John J P', 'Initials': 'JJP', 'LastName': 'Kastelein', 'Affiliation': 'University of Amsterdam, Amsterdam, the Netherlands.'}]",JAMA cardiology,['10.1001/jamacardio.2019.3502'] 1266,29947833,Myocardial reperfusion with tirofiban injection via aspiration catheter : Efficacy and safety in STEMI patients with large thrombus burden.,"BACKGROUND There is no consensus on the use of thrombus aspiration (TA) in primary percutaneous coronary intervention (PPCI), and few studies have focused on the performance of tirofiban via TA catheter after PPCI. Our study investigated the clinical outcome of tirofiban injection through TA in acute ST-segment elevation myocardial infarction (STEMI) patients with large thrombus burden undergoing PPCI treatment. PATIENTS AND METHODS The study comprised 122 STEMI patients who underwent TA during PPCI. Participants were randomly divided into two groups. Group A received intravenous tirofiban injection and tirofiban injection via a TA catheter to the infarcted coronary artery after aspiration (n = 61). Group B received intravenous tirofiban injection only (n = 61). Baseline clinical information and follow-up data were collected for both groups. Coronary angiography, electrocardiography, and echocardiography findings as well as major adverse cardiovascular events (MACE) were recorded. RESULTS There were significant differences in postprocedural Thrombolysis in Myocardial Infarction (TIMI) grade 2 and 3 flow between the two groups (p = 0.021, p = 0.006, respectively). The incidence of slow-flow in group A was significantly lower than that of group B (p = 0.011). An increased incidence of no ST-segment resolution was observed in group B (p = 0.011). There were fewer major adverse cardiovascular events in group A than in group B, but the difference was not statistically significant. CONCLUSION Selective tirofiban injection via TA catheter during PPCI may improve myocardial reperfusion in STEMI patients with large thrombus burden.",2020,There were fewer major adverse cardiovascular events in group ,"['acute ST-segment elevation myocardial infarction (STEMI) patients with large thrombus burden undergoing PPCI treatment', 'STEMI patients with large thrombus burden', 'primary percutaneous coronary intervention (PPCI', '122 STEMI patients who underwent TA during PPCI']","['intravenous tirofiban injection', 'tirofiban injection via aspiration catheter ', 'tirofiban injection through TA', 'tirofiban', 'thrombus aspiration (TA', 'tirofiban injection and tirofiban injection']","['incidence of slow-flow', 'incidence of no ST-segment resolution', 'myocardial reperfusion', 'adverse cardiovascular events', 'postprocedural Thrombolysis in Myocardial Infarction (TIMI) grade\xa02 and 3 flow']","[{'cui': 'C1303258', 'cui_str': 'Acute ST segment elevation myocardial infarction'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0302148', 'cui_str': 'Blood coagulum'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1536220', 'cui_str': 'ST Elevated Myocardial Infarction'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C4081162', 'cui_str': 'tirofiban Injection'}, {'cui': 'C0349707', 'cui_str': 'Aspiration - action (qualifier value)'}, {'cui': 'C0085590', 'cui_str': 'Catheters'}, {'cui': 'C0247025', 'cui_str': 'tirofiban'}, {'cui': 'C0302148', 'cui_str': 'Blood coagulum'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0439834', 'cui_str': 'Slowly'}, {'cui': 'C0429029', 'cui_str': 'ST segment (observable entity)'}, {'cui': 'C0027054', 'cui_str': 'Coronary Reperfusion'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0520997', 'cui_str': 'Thrombolysis, function (observable entity)'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}]",122.0,0.0276769,There were fewer major adverse cardiovascular events in group ,"[{'ForeName': 'Z', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Department of Cardiology, Panyu Central Hospital (Cardiovascular Institute of Panyu District), 511400, Guangzhou, China.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': ""Department of Cardiology, Ganzhou City People's Hospital, 341000, Ganzhou, China.""}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Wu', 'Affiliation': 'Department of Cardiology, Panyu Central Hospital (Cardiovascular Institute of Panyu District), 511400, Guangzhou, China.'}, {'ForeName': 'Q', 'Initials': 'Q', 'LastName': 'Xie', 'Affiliation': 'Department of Cardiology, Panyu Central Hospital (Cardiovascular Institute of Panyu District), 511400, Guangzhou, China.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Cardiology, Panyu Central Hospital (Cardiovascular Institute of Panyu District), 511400, Guangzhou, China.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': 'Department of Cardiology, Panyu Central Hospital (Cardiovascular Institute of Panyu District), 511400, Guangzhou, China.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Ultrasound, Guangdong Women and Children Hospital, No.\xa0521 Xingnan Avenue, 511400, Guangzhou, China. Dr_zhangyl@163.com.'}]",Herz,['10.1007/s00059-018-4716-0'] 1267,31641769,Bedtime hypertension treatment improves cardiovascular risk reduction: the Hygia Chronotherapy Trial.,"AIMS The Hygia Chronotherapy Trial, conducted within the clinical primary care setting, was designed to test whether bedtime in comparison to usual upon awakening hypertension therapy exerts better cardiovascular disease (CVD) risk reduction. METHODS AND RESULTS In this multicentre, controlled, prospective endpoint trial, 19 084 hypertensive patients (10 614 men/8470 women, 60.5 ± 13.7 years of age) were assigned (1:1) to ingest the entire daily dose of ≥1 hypertension medications at bedtime (n = 9552) or all of them upon awakening (n = 9532). At inclusion and at every scheduled clinic visit (at least annually) throughout follow-up, ambulatory blood pressure (ABP) monitoring was performed for 48 h. During the 6.3-year median patient follow-up, 1752 participants experienced the primary CVD outcome (CVD death, myocardial infarction, coronary revascularization, heart failure, or stroke). Patients of the bedtime, compared with the upon-waking, treatment-time regimen showed significantly lower hazard ratio-adjusted for significant influential characteristics of age, sex, type 2 diabetes, chronic kidney disease, smoking, HDL cholesterol, asleep systolic blood pressure (BP) mean, sleep-time relative systolic BP decline, and previous CVD event-of the primary CVD outcome [0.55 (95% CI 0.50-0.61), P < 0.001] and each of its single components (P < 0.001 in all cases), i.e. CVD death [0.44 (0.34-0.56)], myocardial infarction [0.66 (0.52-0.84)], coronary revascularization [0.60 (0.47-0.75)], heart failure [0.58 (0.49-0.70)], and stroke [0.51 (0.41-0.63)]. CONCLUSION Routine ingestion by hypertensive patients of ≥1 prescribed BP-lowering medications at bedtime, as opposed to upon waking, results in improved ABP control (significantly enhanced decrease in asleep BP and increased sleep-time relative BP decline, i.e. BP dipping) and, most importantly, markedly diminished occurrence of major CVD events. TRIAL REGISTRATION ClinicalTrials.gov, number NCT00741585.",2019,"Patients of the bedtime, compared with the upon-waking, treatment-time regimen showed significantly lower hazard ratio-adjusted for significant influential characteristics of age, sex, type 2 diabetes, chronic kidney disease, smoking, HDL cholesterol, asleep systolic blood pressure (BP) mean, sleep-time relative systolic BP decline, and previous CVD event-of the primary CVD outcome [0.55","['19 084 hypertensive patients (10 614 men/8470 women, 60.5\u2009±\u200913.7\u2009years of age']",['Bedtime hypertension treatment'],"['chronic kidney disease, smoking, HDL cholesterol, asleep systolic blood pressure (BP) mean, sleep-time relative systolic BP decline, and previous CVD event-of the primary CVD outcome', 'cardiovascular risk reduction', 'asleep BP and increased sleep-time relative BP decline, i.e. BP dipping', 'ABP control', 'primary CVD outcome (CVD death, myocardial infarction, coronary revascularization, heart failure, or stroke', 'CVD death', 'myocardial infarction', 'coronary revascularization', 'heart failure', 'ambulatory blood pressure (ABP) monitoring', 'cardiovascular disease (CVD) risk reduction']","[{'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0521112', 'cui_str': 'Bedtime (qualifier value)'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C1561643', 'cui_str': 'Chronic Kidney Diseases'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0018667', 'cui_str': 'Cholesterol, HDL2'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0378785', 'cui_str': 'DIPS'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0877341', 'cui_str': 'Coronary revascularisation'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0242876', 'cui_str': 'Blood Pressure Monitoring, Ambulatory'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}, {'cui': 'C1137094', 'cui_str': 'Risk Reduction'}]",1752.0,0.186905,"Patients of the bedtime, compared with the upon-waking, treatment-time regimen showed significantly lower hazard ratio-adjusted for significant influential characteristics of age, sex, type 2 diabetes, chronic kidney disease, smoking, HDL cholesterol, asleep systolic blood pressure (BP) mean, sleep-time relative systolic BP decline, and previous CVD event-of the primary CVD outcome [0.55","[{'ForeName': 'Ramón C', 'Initials': 'RC', 'LastName': 'Hermida', 'Affiliation': 'Bioengineering & Chronobiology Laboratories, Atlantic Research Center for Information and Communication Technologies (AtlantTIC), University of Vigo, E.I. Telecomunicación, Campus Universitario, Vigo 36310, Spain.'}, {'ForeName': 'Juan J', 'Initials': 'JJ', 'LastName': 'Crespo', 'Affiliation': 'Bioengineering & Chronobiology Laboratories, Atlantic Research Center for Information and Communication Technologies (AtlantTIC), University of Vigo, E.I. Telecomunicación, Campus Universitario, Vigo 36310, Spain.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Domínguez-Sardiña', 'Affiliation': 'Estructura de Xestión Integrada de Vigo, Servicio Galego de Saúde (SERGAS), Vigo, Spain.'}, {'ForeName': 'Alfonso', 'Initials': 'A', 'LastName': 'Otero', 'Affiliation': 'Servicio de Nefrología, Complejo Hospitalario Universitario, Estructura de Xestión Integrada de Ourense, Verín e O Barco de Valdeorras, Servicio Galego de Saúde (SERGAS), Ourense 32005, Spain.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Moyá', 'Affiliation': 'Estructura de Xerencia Integrada Pontevedra e O Salnés, Servicio Galego de Saúde (SERGAS), Pontevedra, Spain.'}, {'ForeName': 'María T', 'Initials': 'MT', 'LastName': 'Ríos', 'Affiliation': 'Bioengineering & Chronobiology Laboratories, Atlantic Research Center for Information and Communication Technologies (AtlantTIC), University of Vigo, E.I. Telecomunicación, Campus Universitario, Vigo 36310, Spain.'}, {'ForeName': 'Elvira', 'Initials': 'E', 'LastName': 'Sineiro', 'Affiliation': 'Bioengineering & Chronobiology Laboratories, Atlantic Research Center for Information and Communication Technologies (AtlantTIC), University of Vigo, E.I. Telecomunicación, Campus Universitario, Vigo 36310, Spain.'}, {'ForeName': 'María C', 'Initials': 'MC', 'LastName': 'Castiñeira', 'Affiliation': 'Bioengineering & Chronobiology Laboratories, Atlantic Research Center for Information and Communication Technologies (AtlantTIC), University of Vigo, E.I. Telecomunicación, Campus Universitario, Vigo 36310, Spain.'}, {'ForeName': 'Pedro A', 'Initials': 'PA', 'LastName': 'Callejas', 'Affiliation': 'Bioengineering & Chronobiology Laboratories, Atlantic Research Center for Information and Communication Technologies (AtlantTIC), University of Vigo, E.I. Telecomunicación, Campus Universitario, Vigo 36310, Spain.'}, {'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Pousa', 'Affiliation': 'Bioengineering & Chronobiology Laboratories, Atlantic Research Center for Information and Communication Technologies (AtlantTIC), University of Vigo, E.I. Telecomunicación, Campus Universitario, Vigo 36310, Spain.'}, {'ForeName': 'José L', 'Initials': 'JL', 'LastName': 'Salgado', 'Affiliation': 'Bioengineering & Chronobiology Laboratories, Atlantic Research Center for Information and Communication Technologies (AtlantTIC), University of Vigo, E.I. Telecomunicación, Campus Universitario, Vigo 36310, Spain.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Durán', 'Affiliation': 'Estructura de Xestión Integrada de Vigo, Servicio Galego de Saúde (SERGAS), Vigo, Spain.'}, {'ForeName': 'Juan J', 'Initials': 'JJ', 'LastName': 'Sánchez', 'Affiliation': 'Bioengineering & Chronobiology Laboratories, Atlantic Research Center for Information and Communication Technologies (AtlantTIC), University of Vigo, E.I. Telecomunicación, Campus Universitario, Vigo 36310, Spain.'}, {'ForeName': 'José R', 'Initials': 'JR', 'LastName': 'Fernández', 'Affiliation': 'Bioengineering & Chronobiology Laboratories, Atlantic Research Center for Information and Communication Technologies (AtlantTIC), University of Vigo, E.I. Telecomunicación, Campus Universitario, Vigo 36310, Spain.'}, {'ForeName': 'Artemio', 'Initials': 'A', 'LastName': 'Mojón', 'Affiliation': 'Bioengineering & Chronobiology Laboratories, Atlantic Research Center for Information and Communication Technologies (AtlantTIC), University of Vigo, E.I. Telecomunicación, Campus Universitario, Vigo 36310, Spain.'}, {'ForeName': 'Diana E', 'Initials': 'DE', 'LastName': 'Ayala', 'Affiliation': 'Bioengineering & Chronobiology Laboratories, Atlantic Research Center for Information and Communication Technologies (AtlantTIC), University of Vigo, E.I. Telecomunicación, Campus Universitario, Vigo 36310, Spain.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",European heart journal,['10.1093/eurheartj/ehz754'] 1268,32023365,Transcranial Direct Current Stimulation for Negative Symptoms of Schizophrenia: Why the Reader Must Choose a Clinically Relevant Outcome.,"A recent, large, randomized controlled trial (RCT) of 10 twice-daily sessions of active vs sham transcranial direct current stimulation (tDCS), delivered across 5 consecutive days to schizophrenia patients with high negative symptom burden, found that active treatment was superior to sham treatment by a mean of 2.65 points on the Positive and Negative Syndrome Scale, negative subscale (PANSS-N), at 6 weeks. This was the primary endpoint of the study. Because a difference of 2.65 PANSS-N points between the average active vs sham tDCS patient is a very small advantage, it appears that the finding was statistically but not clinically significant; why this is so is explained in the context of how the PANSS-N is scored. The study also found that, with response defined as 20% attenuation of PANSS-N scores, significantly more (40% vs 4%) active than sham group patients responded at 6 weeks. This was one of many secondary outcomes that the study examined. Because response is a clinically important endpoint, it appears that the finding was clinically as well as statistically significant; why this is so is also explained in the context of PANSS-N scoring. As a final poser, whereas the advantage for active tDCS for both outcomes persisted at 12 weeks, at neither 6 nor 12 weeks was active treatment superior to sham treatment on a global measure of functioning; this suggests that the advantage for active tDCS does not translate into real-life gains. The reader is provided with an understanding of how to critically read a paper that describes an RCT; of how to interpret a continuous outcome measure that describes the average patient versus a categorical outcome measure that describes a clinically important outcome in an entire group; and, most important of all, of the need to choose an outcome that is relevant to clinical practice.",2020,"Because a difference of 2.65 PANSS-N points between the average active vs sham tDCS patient is a very small advantage, it appears that the finding was statistically but not clinically significant; why this is so is explained in the context of how the PANSS-N is scored.","['schizophrenia patients with high negative symptom burden', 'Negative Symptoms of Schizophrenia']","['Transcranial Direct Current Stimulation', 'active vs sham transcranial direct current stimulation (tDCS']",[],"[{'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}]",[],,0.106769,"Because a difference of 2.65 PANSS-N points between the average active vs sham tDCS patient is a very small advantage, it appears that the finding was statistically but not clinically significant; why this is so is explained in the context of how the PANSS-N is scored.","[{'ForeName': 'Chittaranjan', 'Initials': 'C', 'LastName': 'Andrade', 'Affiliation': 'Department of Psychopharmacology, National Institute of Mental Health and Neurosciences, Bangalore, India. candrade@psychiatrist.com.'}]",The Journal of clinical psychiatry,['10.4088/JCP.20f13256'] 1269,29550525,Long-lasting improvement following tDCS treatment combined with a training for reading in children and adolescents with dyslexia.,"Noninvasive brain stimulation transiently modulates reading ability in individuals with dyslexia by facilitating the underactive neural pathways in them. However, its long-term effects have not been determined. This study confirmed the ameliorative effects of multiple sessions of transcranial direct current stimulation (tDCS) combined with a training for reading on the reading abilities of children and adolescents with dyslexia and examined whether they are long-lasting. Twenty-six children and adolescents with dyslexia received 3 20-min sessions per week for 6 weeks (18 sessions) of left anodal/right cathodal tDCS, set to 1 mA, over the parieto-temporal regions, combined with training for reading. The participants were randomly assigned to receive active or sham treatment. Reading measures (text, high- and low-frequency words, non-words) were recorded before and immediately after the treatment and 1 and 6 months later. The long-term tolerability to tDCS was also evaluated. The active group received long-lasting benefits in reading. Specifically, the non-word reading efficiency index improved at every time point, as did the low-frequency word reading efficiency index at 1 and 6 months after the end of the treatment. No differences emerged in the sham group. No long-term adverse effects were documented. This study provides evidence of persistent improvements in reading in children and adolescents with dyslexia, constituting a new rehabilitative approach for the remediation of dyslexia.",2019,"Specifically, the non-word reading efficiency index improved at every time point, as did the low-frequency word reading efficiency index at 1 and 6 months after the end of the treatment.","['children and adolescents with dyslexia and examined whether they are long-lasting', 'Twenty-six children and adolescents with dyslexia', 'individuals with dyslexia', 'children and adolescents with dyslexia']","['Noninvasive brain stimulation', 'left anodal/right cathodal tDCS, set to 1\u202fmA, over the parieto-temporal regions, combined with training for reading', 'tDCS', 'transcranial direct current stimulation (tDCS) combined with a training for reading']","['Reading measures (text, high- and low-frequency words, non-words']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0476254', 'cui_str': 'Reading Disorder'}, {'cui': 'C0450349', 'cui_str': '26 (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C0870227', 'cui_str': 'Brain stimulation'}, {'cui': 'C0205090', 'cui_str': 'Right (qualifier value)'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C1172076', 'cui_str': '1-(PE)-MA'}, {'cui': 'C0039485', 'cui_str': 'Temporal Region'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0034754', 'cui_str': 'Reading'}]","[{'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C3541382', 'cui_str': 'Text'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0205213', 'cui_str': 'Low frequency (qualifier value)'}]",26.0,0.0564326,"Specifically, the non-word reading efficiency index improved at every time point, as did the low-frequency word reading efficiency index at 1 and 6 months after the end of the treatment.","[{'ForeName': 'Floriana', 'Initials': 'F', 'LastName': 'Costanzo', 'Affiliation': ""Child Neuropsychiatric Unit, Bambino Gesù Children's Hospital, IRCCS, Department of Neuroscience, Piazza Sant'Onofrio 4, I-00165 Rome, Italy.""}, {'ForeName': 'Serena', 'Initials': 'S', 'LastName': 'Rossi', 'Affiliation': ""Child Neuropsychiatric Unit, Bambino Gesù Children's Hospital, IRCCS, Department of Neuroscience, Piazza Sant'Onofrio 4, I-00165 Rome, Italy.""}, {'ForeName': 'Cristiana', 'Initials': 'C', 'LastName': 'Varuzza', 'Affiliation': ""Child Neuropsychiatric Unit, Bambino Gesù Children's Hospital, IRCCS, Department of Neuroscience, Piazza Sant'Onofrio 4, I-00165 Rome, Italy.""}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Varvara', 'Affiliation': ""Child Neuropsychiatric Unit, Bambino Gesù Children's Hospital, IRCCS, Department of Neuroscience, Piazza Sant'Onofrio 4, I-00165 Rome, Italy.""}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Vicari', 'Affiliation': ""Child Neuropsychiatric Unit, Bambino Gesù Children's Hospital, IRCCS, Department of Neuroscience, Piazza Sant'Onofrio 4, I-00165 Rome, Italy.""}, {'ForeName': 'Deny', 'Initials': 'D', 'LastName': 'Menghini', 'Affiliation': ""Child Neuropsychiatric Unit, Bambino Gesù Children's Hospital, IRCCS, Department of Neuroscience, Piazza Sant'Onofrio 4, I-00165 Rome, Italy. Electronic address: deny.menghini@opbg.net.""}]",Neuropsychologia,['10.1016/j.neuropsychologia.2018.03.016'] 1270,31630990,"Immunogenicity of chimeric haemagglutinin-based, universal influenza virus vaccine candidates: interim results of a randomised, placebo-controlled, phase 1 clinical trial.","BACKGROUND Influenza viruses cause substantial annual morbidity and mortality globally. Current vaccines protect against influenza only when well matched to the circulating strains. However, antigenic drift can cause considerable mismatches between vaccine and circulating strains, substantially reducing vaccine effectiveness. Moreover, current seasonal vaccines are ineffective against pandemic influenza, and production of a vaccine matched to a newly emerging virus strain takes months. Therefore, there is an unmet medical need for a broadly protective influenza virus vaccine. We aimed to test the ability of chimeric H1 haemagglutinin-based universal influenza virus vaccine candidates to induce broadly cross-reactive antibodies targeting the stalk domain of group 1 haemagglutinin-expressing influenza viruses. METHODS We did a randomised, observer-blinded, phase 1 study in healthy adults in two centres in the USA. Participants were randomly assigned to one of three prime-boost, chimeric haemagglutinin-based vaccine regimens or one of two placebo groups. The vaccine regimens included a chimeric H8/1, intranasal, live-attenuated vaccine on day 1 followed by a non-adjuvanted, chimeric H5/1, intramuscular, inactivated vaccine on day 85; the same regimen but with the inactivated vaccine being adjuvanted with AS03; and an AS03-adjuvanted, chimeric H8/1, intramuscular, inactivated vaccine followed by an AS03-adjuvanted, chimeric H5/1, intramuscular, inactivated vaccine. In this planned interim analysis, the primary endpoints of reactogenicity and safety were assessed by blinded study group. We also assessed anti-H1 haemagglutinin stalk, anti-H2, anti-H9, and anti-H18 IgG antibody titres and plasmablast and memory B-cell responses in peripheral blood. This trial is registered with ClinicalTrials.gov, number NCT03300050. FINDINGS Between Oct 10, 2017, and Nov 27, 2017, 65 participants were enrolled and randomly assigned. The adjuvanted inactivated vaccine, but not the live-attenuated vaccine, induced a substantial serum IgG antibody response after the prime immunisation, with a seven times increase in anti-H1 stalk antibody titres on day 29. After boost immunisation, all vaccine regimens induced detectable anti-H1 stalk antibody (2·2-5·6 times induction over baseline), cross-reactive serum IgG antibody, and peripheral blood plasmablast responses. An unsolicited adverse event was reported for 29 (48%) of 61 participants. Solicited local adverse events were reported in 12 (48%) of 25 participants following prime vaccination with intramuscular study product or placebo, in 12 (33%) of 36 after prime immunisation with intranasal study product or placebo, and in 18 (32%) of 56 following booster doses of study product or placebo. Solicited systemic adverse events were reported in 14 (56%) of 25 after prime immunisation with intramuscular study product or placebo, in 22 (61%) of 36 after immunisation with intranasal study product or placebo, and in 21 (38%) of 56 after booster doses of study product or placebo. Disaggregated safety data were not available at the time of this interim analysis. INTERPRETATION The tested chimeric haemagglutinin-based, universal influenza virus vaccine regimens elicited cross-reactive serum IgG antibodies that targeted the conserved haemagglutinin stalk domain. This is the first proof-of-principle study to show that high anti-stalk titres can be induced by a rationally designed vaccine in humans and opens up avenues for further development of universal influenza virus vaccines. On the basis of the blinded study group, the vaccine regimens were tolerable and no safety concerns were observed. FUNDING Bill & Melinda Gates Foundation.",2020,"Solicited local adverse events were reported in 12 (48%) of 25 participants following prime vaccination with intramuscular study product or placebo, in 12 (33%) of 36 after prime immunisation with intranasal study product or placebo, and in 18 (32%) of 56 following booster doses of study product or placebo.","['healthy adults in two centres in the USA', 'peripheral blood', 'Between Oct 10, 2017, and Nov 27, 2017, 65 participants were enrolled and randomly assigned']","['placebo', 'chimeric haemagglutinin-based vaccine regimens or one of two placebo', 'chimeric H8/1, intranasal, live-attenuated vaccine', 'inactivated vaccine being adjuvanted with AS03; and an AS03-adjuvanted, chimeric H8/1, intramuscular, inactivated vaccine followed by an AS03-adjuvanted, chimeric H5/1, intramuscular, inactivated vaccine']","['Solicited systemic adverse events', 'detectable anti-H1 stalk antibody (2·2-5·6 times induction over baseline), cross-reactive serum IgG antibody, and peripheral blood plasmablast responses', 'tolerable and no safety concerns', 'anti-H1 stalk antibody titres', 'reactogenicity and safety', 'anti-H1 haemagglutinin stalk, anti-H2, anti-H9, and anti-H18 IgG antibody titres and plasmablast and memory B-cell responses', 'vaccine effectiveness', 'Solicited local adverse events', 'substantial serum IgG antibody response']","[{'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood (substance)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach (qualifier value)'}, {'cui': 'C0442117', 'cui_str': 'Intramuscular (qualifier value)'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}]","[{'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0935572', 'cui_str': 'Stalkings'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205203', 'cui_str': 'Crossed (qualifier value)'}, {'cui': 'C0205332', 'cui_str': 'Reactive (qualifier value)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood (substance)'}, {'cui': 'C0229657', 'cui_str': 'Plasmablast (cell)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1287242', 'cui_str': 'Finding of antibody titer (finding)'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0004561', 'cui_str': 'B-Cells'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0003261', 'cui_str': 'Antibody Response'}]",65.0,0.338098,"Solicited local adverse events were reported in 12 (48%) of 25 participants following prime vaccination with intramuscular study product or placebo, in 12 (33%) of 36 after prime immunisation with intranasal study product or placebo, and in 18 (32%) of 56 following booster doses of study product or placebo.","[{'ForeName': 'David I', 'Initials': 'DI', 'LastName': 'Bernstein', 'Affiliation': ""Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, OH, USA; Division of Infectious Diseases, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.""}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Guptill', 'Affiliation': 'Duke Early Phase Clinical Research Unit, Duke Clinical Research Institute, Durham, NC, USA.'}, {'ForeName': 'Abdollah', 'Initials': 'A', 'LastName': 'Naficy', 'Affiliation': 'Center for Vaccine Innovation and Access, PATH, Seattle, WA, USA.'}, {'ForeName': 'Raffael', 'Initials': 'R', 'LastName': 'Nachbagauer', 'Affiliation': 'Department of Microbiology, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Berlanda-Scorza', 'Affiliation': 'Center for Vaccine Innovation and Access, PATH, Seattle, WA, USA.'}, {'ForeName': 'Jodi', 'Initials': 'J', 'LastName': 'Feser', 'Affiliation': 'Center for Vaccine Innovation and Access, PATH, Seattle, WA, USA.'}, {'ForeName': 'Patrick C', 'Initials': 'PC', 'LastName': 'Wilson', 'Affiliation': 'Section of Rheumatology, Department of Medicine, University of Chicago, Chicago, IL, USA; The Committee on Immunology, University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Solórzano', 'Affiliation': 'Department of Microbiology, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Van der Wielen', 'Affiliation': 'GlaxoSmithKline, Wavre, Belgium.'}, {'ForeName': 'Emmanuel B', 'Initials': 'EB', 'LastName': 'Walter', 'Affiliation': 'Duke Early Phase Clinical Research Unit, Duke Clinical Research Institute, Durham, NC, USA; Duke Human Vaccine Institute, Duke University School of Medicine, Durham, NC, USA.'}, {'ForeName': 'Randy A', 'Initials': 'RA', 'LastName': 'Albrecht', 'Affiliation': 'Department of Microbiology, Icahn School of Medicine at Mount Sinai, New York, NY, USA; Global Health and Emerging Pathogens Institute, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Kristen N', 'Initials': 'KN', 'LastName': 'Buschle', 'Affiliation': ""Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, OH, USA; Division of Infectious Diseases, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.""}, {'ForeName': 'Yao-Qing', 'Initials': 'YQ', 'LastName': 'Chen', 'Affiliation': 'Section of Rheumatology, Department of Medicine, University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Carine', 'Initials': 'C', 'LastName': 'Claeys', 'Affiliation': 'GlaxoSmithKline, Wavre, Belgium.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Dickey', 'Affiliation': ""Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, OH, USA; Division of Infectious Diseases, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.""}, {'ForeName': 'Haley L', 'Initials': 'HL', 'LastName': 'Dugan', 'Affiliation': 'The Committee on Immunology, University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Megan E', 'Initials': 'ME', 'LastName': 'Ermler', 'Affiliation': 'Department of Microbiology, Icahn School of Medicine at Mount Sinai, New York, NY, USA; GlaxoSmithKline, Collegeville, PA, USA.'}, {'ForeName': 'Debra', 'Initials': 'D', 'LastName': 'Freeman', 'Affiliation': 'Duke Early Phase Clinical Research Unit, Duke Clinical Research Institute, Durham, NC, USA.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Gao', 'Affiliation': 'Duke Early Phase Clinical Research Unit, Duke Clinical Research Institute, Durham, NC, USA.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Gast', 'Affiliation': 'Center for Vaccine Innovation and Access, PATH, Seattle, WA, USA.'}, {'ForeName': 'Jenna J', 'Initials': 'JJ', 'LastName': 'Guthmiller', 'Affiliation': 'Section of Rheumatology, Department of Medicine, University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Hai', 'Affiliation': 'Department of Microbiology, Icahn School of Medicine at Mount Sinai, New York, NY, USA; Department of Microbiology and Plant Pathology, Institute for Integrative Genome Biology, University of California, Riverside, CA, USA.'}, {'ForeName': 'Carole', 'Initials': 'C', 'LastName': 'Henry', 'Affiliation': 'Section of Rheumatology, Department of Medicine, University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Linda Yu-Ling', 'Initials': 'LY', 'LastName': 'Lan', 'Affiliation': 'The Committee on Immunology, University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'McNeal', 'Affiliation': ""Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, OH, USA; Division of Infectious Diseases, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.""}, {'ForeName': 'Anna-Karin E', 'Initials': 'AE', 'LastName': 'Palm', 'Affiliation': 'Section of Rheumatology, Department of Medicine, University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Dustin G', 'Initials': 'DG', 'LastName': 'Shaw', 'Affiliation': 'The Committee on Immunology, University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Christopher T', 'Initials': 'CT', 'LastName': 'Stamper', 'Affiliation': 'The Committee on Immunology, University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Weina', 'Initials': 'W', 'LastName': 'Sun', 'Affiliation': 'Department of Microbiology, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Sutton', 'Affiliation': 'Duke Early Phase Clinical Research Unit, Duke Clinical Research Institute, Durham, NC, USA.'}, {'ForeName': 'Micah E', 'Initials': 'ME', 'LastName': 'Tepora', 'Affiliation': 'Section of Rheumatology, Department of Medicine, University of Chicago, Chicago, IL, USA.'}, {'ForeName': 'Rahnuma', 'Initials': 'R', 'LastName': 'Wahid', 'Affiliation': 'Center for Vaccine Innovation and Access, PATH, Seattle, WA, USA.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Wenzel', 'Affiliation': 'Center for Vaccine Innovation and Access, PATH, Seattle, WA, USA.'}, {'ForeName': 'Teddy John', 'Initials': 'TJ', 'LastName': 'Wohlbold', 'Affiliation': 'Department of Microbiology, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Bruce L', 'Initials': 'BL', 'LastName': 'Innis', 'Affiliation': 'Center for Vaccine Innovation and Access, PATH, Seattle, WA, USA.'}, {'ForeName': 'Adolfo', 'Initials': 'A', 'LastName': 'García-Sastre', 'Affiliation': 'Department of Microbiology, Icahn School of Medicine at Mount Sinai, New York, NY, USA; Global Health and Emerging Pathogens Institute, Icahn School of Medicine at Mount Sinai, New York, NY, USA; Department of Medicine, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Palese', 'Affiliation': 'Department of Microbiology, Icahn School of Medicine at Mount Sinai, New York, NY, USA; Department of Medicine, Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Krammer', 'Affiliation': 'Department of Microbiology, Icahn School of Medicine at Mount Sinai, New York, NY, USA. Electronic address: florian.krammer@mssm.edu.'}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(19)30393-7'] 1271,31629649,"Serological response to three alternative series of hepatitis B revaccination (Fendrix, Twinrix, and HBVaxPro-40) in healthy non-responders: a multicentre, open-label, randomised, controlled, superiority trial.","BACKGROUND Serological non-response can be present after hepatitis B vaccination in healthy adults. We aimed to establish which of three revaccination regimens is most effective at inducing protective immunity METHODS: Healthy adults (aged 18-80 years) from 16 Dutch centres (13 public health services, two university hospitals, and one travel clinic) were included in this multicentre, parallel group, randomised, controlled, superiority trial. The inclusion criterion was vaccine non-response (hepatitis B surface antibody [anti-HBs] titre <10 IU/L) after a primary series with three doses of one type of recombinant vaccine against hepatitis B virus (either HBVaxPro-10 or Engerix-B at months 0, 1, and 6). Participants were individually randomly assigned (1:1:1:1) to a vaccination series of repeated initial vaccination (HBVaxPro 10 μg or Engerix-B 20 μg) as the control, or to Twinrix 20 μg, Fendrix 20 μg, or HBVaxPro 40 μg. We used a web-based randomisation programme, stratified by centre, with a block size of four. Participants and centres were unmasked to assignment after randomisation. Laboratory staff and investigators were masked to vaccine-group assignment. All revaccination schedules were identical, with intramuscular vaccinations at 0, 1, and 2 months. Anti-HBs was measured at 0, 1, 2, and 3 months. The primary outcome was the percentage of responders (anti-HBs titres ≥10 IU/L) at 3 months. Immunogenicity and safety analyses were based on an intention-to-vaccinate analysis, the immunogenicity analysis with last observation carried forward for missing data, and the Bonferroni and the Benjamini-Hochberg method were applied to correct for multiple testing. The trial was registered in the Dutch National Trial Register and inclusion has been stopped (identifier NL3011; EudraCT-number 2011-005627-40). FINDINGS The participants were recruited between Nov 1, 2012, and Sept 1, 2017. 480 participants were randomly assigned and included in intention-to-vaccinate analyses: 124 (26%) to control, 118 (25%) to Twinrix, 114 (24%) to HBVaxPro-40, and 124 (26%) to Fendrix. At month 3 the percentage of responders was 83 (67%) of 124 (95% CI 57·9-75·1 in the control group, 94 (80%) of the 118 (71·3-86·5) in the Twinrix group, 95 (83%) of 114 (75·2-89·7) in the HBVaxPro-40 group, and 108 (87%) of 124 (79·9-92·4) in the Fendrix group. Compared with the control group, the percentage of responders was superior for the HBVaxPro-40 group (adjusted difference 21·6% [95% CI 10·4-32·7], p=0·0204 [Bonferroni corrected p value]) and the Fendrix group (26·3% [15·4-37·3], p=0·0006), but not the Twinrix group (25·0% [13·0-37·0]; p=0·0846). One serious adverse event occurred (herpes zoster ophthalmicus) in the Fendrix group, which was not attributed to the vaccine. INTERPRETATION Revaccinating healthy non-responders with Fendrix or HBVaxPro-40 resulted in significantly higher proportions of responders and therefore indication for these vaccines should be expanded to enable revaccination of non-responders. FUNDING National Institute for Public Health and the Environment.",2020,"One serious adverse event occurred (herpes zoster ophthalmicus) in the Fendrix group, which was not attributed to the vaccine. ","['Healthy adults (aged 18-80 years) from 16 Dutch centres (13 public health services, two university hospitals, and one travel clinic', 'participants were recruited between Nov 1, 2012, and Sept 1, 2017', '480 participants', 'healthy adults', 'healthy non-responders']","['HBVaxPro-40', 'hepatitis B revaccination (Fendrix, Twinrix, and HBVaxPro-40', 'vaccination series of repeated initial vaccination (HBVaxPro 10 μg or Engerix-B 20 μg) as the control, or to Twinrix 20 μg, Fendrix 20 μg, or HBVaxPro 40 μg', 'recombinant vaccine against hepatitis B virus (either HBVaxPro-10']","['Anti-HBs', 'Immunogenicity and safety analyses', 'percentage of responders (anti-HBs titres ≥10 IU/L']","[{'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0013331', 'cui_str': 'Dutch (ethnic group)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0699943', 'cui_str': 'Public health service (qualifier value)'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0040802', 'cui_str': 'Travel (event)'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C4319609', 'cui_str': '480'}]","[{'cui': 'C0019163', 'cui_str': 'Hepatitis B Virus Infection'}, {'cui': 'C2713304', 'cui_str': 'Revaccination'}, {'cui': 'C1872587', 'cui_str': 'Fendrix'}, {'cui': 'C0593953', 'cui_str': 'Twinrix'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0205549', 'cui_str': 'Series (qualifier value)'}, {'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0116078', 'cui_str': 'Engerix-B'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0034862', 'cui_str': 'Vaccines, Recombinant'}, {'cui': 'C0019169', 'cui_str': 'Hepatitis B Virus'}]","[{'cui': 'C0369334', 'cui_str': 'Antibody to hepatitis B surface antigen (substance)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0475208', 'cui_str': 'TITR'}, {'cui': 'C0439457', 'cui_str': 'milliinternational unit/milliliter'}]",480.0,0.286597,"One serious adverse event occurred (herpes zoster ophthalmicus) in the Fendrix group, which was not attributed to the vaccine. ","[{'ForeName': 'Stijn F H', 'Initials': 'SFH', 'LastName': 'Raven', 'Affiliation': 'Department of Infectious Diseases, Regional Public Health Service West Brabant, Breda, Netherlands; Department of Medical Microbiology, Care and Public Health Research Institute (CAPHRI), Maastricht University Medical Centre, Maastricht, Netherlands. Electronic address: stijn.raven@radboudumc.nl.'}, {'ForeName': 'Christian J P A', 'Initials': 'CJPA', 'LastName': 'Hoebe', 'Affiliation': 'Department of Medical Microbiology, Care and Public Health Research Institute (CAPHRI), Maastricht University Medical Centre, Maastricht, Netherlands; Department of Sexual Health, Infectious Diseases and Environmental Health, South Limburg Public Health Service, Netherlands.'}, {'ForeName': 'Ann C T M', 'Initials': 'ACTM', 'LastName': 'Vossen', 'Affiliation': 'Department of Medical Microbiology, Leiden University Medical Centre, Leiden, Netherlands.'}, {'ForeName': 'Leo G', 'Initials': 'LG', 'LastName': 'Visser', 'Affiliation': 'Department of Infectious Diseases, Leiden University Medical Centre, Leiden, Netherlands.'}, {'ForeName': 'Jeannine L A', 'Initials': 'JLA', 'LastName': 'Hautvast', 'Affiliation': 'Department of Primary and Community Care, Radboud Institute for Health Sciences, Radboud University Medical Center, Nijmegen, Netherlands.'}, {'ForeName': 'Anna H E', 'Initials': 'AHE', 'LastName': 'Roukens', 'Affiliation': 'Department of Infectious Diseases, Leiden University Medical Centre, Leiden, Netherlands.'}, {'ForeName': 'Jim E', 'Initials': 'JE', 'LastName': 'van Steenbergen', 'Affiliation': 'Department of Infectious Diseases, Leiden University Medical Centre, Leiden, Netherlands; Centre for Infectious Disease Control, National Institute for Public Health and the Environment, Bilthoven, Netherlands.'}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(19)30417-7'] 1272,29571974,An interactive contouring module improves engagement and interest in radiation oncology among preclinical medical students: Results of a randomized trial.,"PURPOSE Studies have shown significant gaps in knowledge of radiation therapy among medical students and primary care providers. The goal of this study was to evaluate the effect of an interactive contouring module on knowledge and interest in radiation oncology among preclinical medical students. METHODS AND MATERIALS Second-year medical students at the University of California, San Diego were randomized to participate in an interactive contouring exercise or watch a traditional didactic lecture on radiation oncology. Participants completed knowledge tests and surveys at baseline, immediately following the exercise, and 3 months later. Statistical analysis included Wilcoxon signed-rank test for pre- and posttest comparisons and Wilcoxon rank sum test for comparison between groups. RESULTS Forty-three medical students participated in the trial (21 in the didactic group; 22 in the contouring group). Students completing the contouring module demonstrated similar overall knowledge improvement compared with the traditional didactic group (+8.6% vs +6.6%, not significant) but endorsed greater engagement on a 5-point Likert-type scale (3.10 vs 3.76, P = .02). At 3-month follow-up, there was a nonsignificant trend toward improved overall knowledge in the contouring group (43% vs 51%, P = .10), with a significance difference in a subset of questions on knowledge of the process of radiation therapy as well as side effects (51% vs 75%, P = .002). Students in the contouring group demonstrated more interest in pursuing a clinical radiation oncology rotation (2.52 vs 3.27, P = .01). CONCLUSIONS Use of an interactive contouring module was an effective method to teach preclinical medical students about radiation oncology, with no significant difference in knowledge gained compared with a traditional didactic lecture; however, higher engagement among students completing the contouring module led to improved retention of knowledge of radiation side effects and greater interest in radiation oncology. These data suggest a potential benefit of integrating an interactive radiation oncology module into the preclinical medical school curriculum.",2018,"Students completing the contouring module demonstrated similar overall knowledge improvement compared with the traditional didactic group (+8.6% vs +6.6%, not significant) but endorsed greater engagement on a 5-point Likert-type scale (3.10 vs 3.76, P = .02).","['medical students and primary care providers', 'Forty-three medical students participated in the trial (21 in the didactic group; 22 in the contouring group', 'preclinical medical students', 'Second-year medical students at the University of California, San Diego']","['interactive contouring exercise or watch a traditional didactic lecture on radiation oncology', 'interactive contouring module']","['5-point Likert-type scale', 'overall knowledge improvement', 'side effects', 'retention of knowledge of radiation side effects', 'overall knowledge', 'clinical radiation oncology rotation']","[{'cui': 'C0038495', 'cui_str': 'Students, Medical'}, {'cui': 'C2735026', 'cui_str': 'Primary care provider (occupation)'}, {'cui': 'C0450368', 'cui_str': '43 (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0006754', 'cui_str': 'California'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0376683', 'cui_str': 'Lecture'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C3542953', 'cui_str': 'Module (core metadata concept)'}]","[{'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}]",,0.0261545,"Students completing the contouring module demonstrated similar overall knowledge improvement compared with the traditional didactic group (+8.6% vs +6.6%, not significant) but endorsed greater engagement on a 5-point Likert-type scale (3.10 vs 3.76, P = .02).","[{'ForeName': 'Pushpa', 'Initials': 'P', 'LastName': 'Neppala', 'Affiliation': 'Department of Radiation Medicine and Applied Sciences, University of California San Diego, La Jolla, California.'}, {'ForeName': 'Michael V', 'Initials': 'MV', 'LastName': 'Sherer', 'Affiliation': 'Department of Radiation Medicine and Applied Sciences, University of California San Diego, La Jolla, California.'}, {'ForeName': 'Grant', 'Initials': 'G', 'LastName': 'Larson', 'Affiliation': 'Department of Radiation Medicine and Applied Sciences, University of California San Diego, La Jolla, California.'}, {'ForeName': 'Alex K', 'Initials': 'AK', 'LastName': 'Bryant', 'Affiliation': 'Department of Radiation Medicine and Applied Sciences, University of California San Diego, La Jolla, California.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Panjwani', 'Affiliation': 'Department of Radiation Medicine and Applied Sciences, University of California San Diego, La Jolla, California.'}, {'ForeName': 'James D', 'Initials': 'JD', 'LastName': 'Murphy', 'Affiliation': 'Department of Radiation Medicine and Applied Sciences, University of California San Diego, La Jolla, California.'}, {'ForeName': 'Erin F', 'Initials': 'EF', 'LastName': 'Gillespie', 'Affiliation': 'Department of Radiation Medicine and Applied Sciences, University of California San Diego, La Jolla, California; Department of Radiation Oncology, Memorial Sloan Kettering Cancer Center, New York, New York. Electronic address: efgillespie@ucsd.edu.'}]",Practical radiation oncology,['10.1016/j.prro.2018.01.001'] 1273,29577915,Training contraceptive providers to offer intrauterine devices and implants in contraceptive care: a cluster randomized trial.,"BACKGROUND US unintended pregnancy rates remain high, and contraceptive providers are not universally trained to offer intrauterine devices and implants to women who wish to use these methods. OBJECTIVE We sought to measure the impact of a provider training intervention on integration of intrauterine devices and implants into contraceptive care. STUDY DESIGN We measured the impact of a continuing medical education-accredited provider training intervention on provider attitudes, knowledge, and practices in a cluster randomized trial in 40 US health centers from 2011 through 2013. Twenty clinics were randomly assigned to the intervention arm; 20 offered routine care. Clinic staff participated in baseline and 1-year surveys assessing intrauterine device and implant knowledge, attitudes, and practices. We used a difference-in-differences approach to compare changes that occurred in the intervention sites to changes in the control sites 1 year later. Prespecified outcome measures included: knowledge of patient eligibility for intrauterine devices and implants; attitudes about method safety; and counseling practices. We used multivariable regression with generalized estimating equations to account for clustering by clinic to examine intervention effects on provider outcomes 1 year later. RESULTS Overall, we surveyed 576 clinic staff (314 intervention, 262 control) at baseline and/or 1-year follow-up. The change in proportion of providers who believed that the intrauterine device was safe was greater in intervention (60% at baseline to 76% at follow-up) than control sites (66% at both times) (adjusted odds ratio, 2.48; 95% confidence interval, 1.13-5.4). Likewise, for the implant, the proportion increased from 57-77% in intervention, compared to 61-65% in control sites (adjusted odds ratio, 2.57; 95% confidence interval, 1.44-4.59). The proportion of providers who believed they were experienced to counsel on intrauterine devices also increased in intervention (53-67%) and remained the same in control sites (60%) (adjusted odds ratio, 1.89; 95% confidence interval, 1.04-3.44), and for the implant increased more in intervention (41-62%) compared to control sites (48-50%) (adjusted odds ratio, 2.30; 95% confidence interval, 1.28-4.12). Knowledge scores of patient eligibility for intrauterine devices increased at intervention sites (from 0.77-0.86) 6% more over time compared to control sites (from 0.78-0.80) (adjusted coefficient, 0.058; 95% confidence interval, 0.003-0.113). Knowledge scores of eligibility for intrauterine device and implant use with common medical conditions increased 15% more in intervention (0.65-0.79) compared to control sites (0.67-0.66) (adjusted coefficient, 0.15; 95% confidence interval, 0.09-0.21). Routine discussion of intrauterine devices and implants by providers in intervention sites increased significantly, 71-87%, compared to in control sites, 76-82% (adjusted odds ratio, 1.97; 95% confidence interval, 1.02-3.80). CONCLUSION Professional guidelines encourage intrauterine device and implant competency for all contraceptive care providers. Integrating these methods into routine care is important for access. This replicable training intervention translating evidence into care had a sustained impact on provider attitudes, knowledge, and counseling practices, demonstrating significant changes in clinical care a full year after the training intervention.",2018,"Knowledge scores of patient eligibility for intrauterine devices increased at intervention sites (from 0.77-0.86) 6% more over time compared to control sites (from 0.78-0.80) (adjusted coefficient, 0.058; 95% confidence interval, 0.003-0.113).","['surveyed 576 clinic staff (314 intervention, 262 control) at baseline and/or 1-year follow-up', 'Twenty clinics', '40 US health centers from 2011 through 2013']","['provider training intervention', 'continuing medical education-accredited provider training intervention']","['Knowledge scores of patient eligibility for intrauterine devices', 'counsel on intrauterine devices', 'Knowledge scores of eligibility for intrauterine device and implant use with common medical conditions', ' knowledge of patient eligibility for intrauterine devices and implants; attitudes about method safety; and counseling practices']","[{'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C2700616', 'cui_str': 'Manpowers'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0475309', 'cui_str': 'Health center (environment)'}]","[{'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0013632', 'cui_str': 'Education, Medical, Continuing'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0021900', 'cui_str': 'Contraceptive Devices, Intrauterine'}, {'cui': 'C0341618', 'cui_str': 'Counsel (occupation)'}, {'cui': 'C2828363', 'cui_str': 'Implant'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0205214', 'cui_str': 'Common (qualifier value)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}]",20.0,0.226919,"Knowledge scores of patient eligibility for intrauterine devices increased at intervention sites (from 0.77-0.86) 6% more over time compared to control sites (from 0.78-0.80) (adjusted coefficient, 0.058; 95% confidence interval, 0.003-0.113).","[{'ForeName': 'Kirsten M J', 'Initials': 'KMJ', 'LastName': 'Thompson', 'Affiliation': 'Bixby Center for Global Reproductive Health, Department of Obstetrics, Gynecology, and Reproductive Sciences, University of California, San Francisco, San Francisco, CA.'}, {'ForeName': 'Corinne H', 'Initials': 'CH', 'LastName': 'Rocca', 'Affiliation': 'Bixby Center for Global Reproductive Health, Department of Obstetrics, Gynecology, and Reproductive Sciences, University of California, San Francisco, San Francisco, CA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Stern', 'Affiliation': 'Planned Parenthood Northern California, Concord, CA.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Morfesis', 'Affiliation': 'Planned Parenthood Federation of America Inc., New York, NY.'}, {'ForeName': 'Suzan', 'Initials': 'S', 'LastName': 'Goodman', 'Affiliation': 'Bixby Center for Global Reproductive Health, Department of Obstetrics, Gynecology, and Reproductive Sciences, University of California, San Francisco, San Francisco, CA.'}, {'ForeName': 'Jody', 'Initials': 'J', 'LastName': 'Steinauer', 'Affiliation': 'Bixby Center for Global Reproductive Health, Department of Obstetrics, Gynecology, and Reproductive Sciences, University of California, San Francisco, San Francisco, CA.'}, {'ForeName': 'Cynthia C', 'Initials': 'CC', 'LastName': 'Harper', 'Affiliation': 'Bixby Center for Global Reproductive Health, Department of Obstetrics, Gynecology, and Reproductive Sciences, University of California, San Francisco, San Francisco, CA. Electronic address: cynthia.harper@ucsf.edu.'}]",American journal of obstetrics and gynecology,['10.1016/j.ajog.2018.03.016'] 1274,31635919,Incidence and Factors Contributing to Low Back Pain in the Nonobstetrical Patients Operated Under Spinal Anesthesia: A Prospective 1-Year Follow-Up Study.,"PURPOSE To determine the incidence and factors contributing to postspinal anesthesia (SPA) low back pain (LBP) in patients undergoing nonobstetrical surgeries. DESIGN A prospective 1-year follow-up study. METHODS Patients having nonobstetrical surgery using SPA were included. The patients were followed up through phone calls and interviews every postoperative day for the first week, weekly for a month, and then monthly for a year after SPA. Patients' duration of LBP, duration of surgery, and need for LBP treatment were recorded. FINDINGS Of 410 patients, 5.8% (24 patients) experienced LBP. The incidence of LBP did not have a significant correlation with the recorded variables (P > .05). There was a negative significant correlation between duration of LBP and duration of surgery (r = -0.5096; P = .001). Of the 24 patients experiencing LBP, 16.7% (four patients) experienced it for less than 1 day, 66.7% (16 patients) 1 to 7 days, 16.7% (four patients) more than 7 days, and only one patient (4.2%) for up to 17 days. Special LBP treatment was not needed in any of the patients. CONCLUSIONS The incidence of LBP was very low, and those patients undergoing nonobstetrical surgery and receiving SPA did not experience persistent LBP.",2020,The incidence of LBP did not have a significant correlation with the recorded variables (P > .05).,"['patients undergoing nonobstetrical surgeries', 'Nonobstetrical Patients Operated Under Spinal Anesthesia', 'Patients having nonobstetrical surgery using SPA were included', 'Of 410 patients, 5.8% (24 patients) experienced LBP']",['postspinal anesthesia (SPA) low back pain (LBP'],"['duration of LBP, duration of surgery, and need for LBP treatment', 'duration of LBP and duration of surgery', 'incidence of LBP']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0002928', 'cui_str': 'Spinal Anesthesia'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C4517796', 'cui_str': '5.8'}]","[{'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C0024031', 'cui_str': 'Low Back Ache'}]","[{'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0220856', 'cui_str': 'incidence'}]",410.0,0.0196354,The incidence of LBP did not have a significant correlation with the recorded variables (P > .05).,"[{'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Forozeshfard', 'Affiliation': 'Cancer Research Center and Department of Anesthesiology, Semnan University of Medical Sciences, Semnan, Iran.'}, {'ForeName': 'Elahe', 'Initials': 'E', 'LastName': 'Jahan', 'Affiliation': 'Department of Nursing, Semnan branch, Islamic Azad University, Semnan, Iran.'}, {'ForeName': 'Jaafar', 'Initials': 'J', 'LastName': 'Amirsadat', 'Affiliation': 'Department of Anesthesiology and Critical Care, Sina Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Raheb', 'Initials': 'R', 'LastName': 'Ghorbani', 'Affiliation': 'Department of Epidemiology and Statistic, Research Center of Health Social Determinants, Semnan University of Medical Sciences, Semnan, Iran. Electronic address: r_ghorbani@semums.ac.ir.'}]",Journal of perianesthesia nursing : official journal of the American Society of PeriAnesthesia Nurses,['10.1016/j.jopan.2019.06.008'] 1275,31876052,Double-blind placebo controlled trial of the anxiolytic effects of a standardized Echinacea extract.,"Earlier studies suggested that specific Echinacea preparations might decrease anxiety. To further study the issue, we performed a double blind, placebo controlled trial with a standardized Echinacea angustifolia root extract. Participants were volunteers scoring above 45 points on the state or on the trait subscale of the State Trait Anxiety Inventory (STAI). They were treated with 40 mg Echinacea or with placebo tablets twice daily for 7 days followed by a 3 week-long washout period. Participants were also administered the Beck Depression Inventory (BDI) and the Perceived Stress Scale (PSS). In the Echinacea group, state anxiety scores decreased by approximately 11 points by the end of the treatment period, whereas the decrease was around 3-points in the placebo group (p< 0.01). The effect maintained over the washout period. The difference from placebo was significant from the 7th day of treatment throughout. Changes were less robust with trait anxiety scores, but the preparation performed better than placebo in patients with high baseline anxiety. Neither BDI nor PSS scores were affected by the treatments. Adverse effects were rare and mild, and all were observed in the placebo group. These findings suggest that particular Echinacea preparations have significant beneficial effects on anxiety in humans.",2020,"In the Echinacea group, state anxiety scores decreased by approximately 11 points by the end of the treatment period, whereas the decrease was around 3-points in the placebo group (p< 0.01).",['patients with high baseline anxiety'],"['placebo', 'standardized Echinacea angustifolia root extract', 'standardized Echinacea extract']","['trait subscale of the State Trait Anxiety Inventory (STAI', 'state anxiety scores', 'BDI nor PSS scores', 'Beck Depression Inventory (BDI) and the Perceived Stress Scale (PSS', 'anxiety', 'Adverse effects', 'trait anxiety scores']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0873078', 'cui_str': 'Echinacea angustifolia root extract'}, {'cui': 'C0752270', 'cui_str': 'Echinacea Preparation'}]","[{'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory (assessment scale)'}, {'cui': 'C0582653', 'cui_str': 'Perceived stress scale (assessment scale)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}]",,0.290201,"In the Echinacea group, state anxiety scores decreased by approximately 11 points by the end of the treatment period, whereas the decrease was around 3-points in the placebo group (p< 0.01).","[{'ForeName': 'József', 'Initials': 'J', 'LastName': 'Haller', 'Affiliation': 'Institute of Experimental Medicine, Budapest, Hungary.'}, {'ForeName': 'Laszlo', 'Initials': 'L', 'LastName': 'Krecsak', 'Affiliation': 'Independent Consultant, Budapest, Hungary.'}, {'ForeName': 'János', 'Initials': 'J', 'LastName': 'Zámbori', 'Affiliation': 'MedResearch Kft, Budapest, Hungary.'}]",Phytotherapy research : PTR,['10.1002/ptr.6558'] 1276,31637821,Temporal trends of population viral suppression in the context of Universal Test and Treat: the ANRS 12249 TasP trial in rural South Africa.,"INTRODUCTION The universal test-and-treat (UTT) strategy aims to maximize population viral suppression (PVS), that is, the proportion of all people living with HIV (PLHIV) on antiretroviral treatment (ART) and virally suppressed, with the goal of reducing HIV transmission at the population level. This article explores the extent to which temporal changes in PVS explain the observed lack of association between universal treatment and cumulative HIV incidence seen in the ANRS 12249 TasP trial conducted in rural South Africa. METHODS The TasP cluster-randomized trial (2012 to 2016) implemented six-monthly repeat home-based HIV counselling and testing (RHBCT) and referral of PLHIV to local HIV clinics in 2 × 11 clusters opened sequentially. ART was initiated according to national guidelines in control clusters and regardless of CD4 count in intervention clusters. We measured residency status, HIV status, and HIV care status for each participant on a daily basis. PVS was computed per cluster among all resident PLHIV (≥16, including those not in care) at cluster opening and daily thereafter. We used a mixed linear model to explore time patterns in PVS, adjusting for sociodemographic changes at the cluster level. RESULTS 8563 PLHIV were followed. During the course of the trial, PVS increased significantly in both arms (23.5% to 46.2% in intervention, +22.8, p < 0.001; 26.0% to 44.6% in control, +18.6, p < 0.001). That increase was similar in both arms (p = 0.514). In the final adjusted model, PVS increase was most associated with increased RHBCT and the implementation of local trial clinics (measured by time since cluster opening). Contextual changes (measured by calendar time) also contributed slightly. The effect of universal ART (trial arm) was positive but limited. CONCLUSIONS PVS was improved significantly but similarly in both trial arms, explaining partly the null effect observed in terms of cumulative HIV incidence between arms. The PVS gains due to changes in ART-initiation guidelines alone are relatively small compared to gains obtained by strategies to maximize testing and linkage to care. The achievement of the 90-90-90 targets will not be met if the operational and implementational challenges limiting access to care and treatment, often context-specific, are not properly addressed. Clinical trial number: NCT01509508 (clinicalTrials.gov)/DOH-27-0512-3974 (South African National Clinical Trials Register).",2019,"During the course of the trial, PVS increased significantly in both arms (23.5% to 46.2% in intervention, +22.8, p < 0.001; 26.0% to 44.6% in control, +18.6, p < 0.001).",['rural South Africa'],"['six-monthly repeat home-based HIV counselling and testing (RHBCT) and referral of PLHIV to local HIV clinics in 2\xa0×\xa011 clusters opened sequentially', 'universal ART']","['PVS', 'Contextual changes', 'cumulative HIV incidence', 'residency status, HIV status, and HIV care status']","[{'cui': 'C0037712', 'cui_str': 'Union of South Africa'}]","[{'cui': 'C0585339', 'cui_str': 'q6mo'}, {'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0730426', 'cui_str': 'Human immunodeficiency virus counseling'}, {'cui': 'C0034927', 'cui_str': 'Referral'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0175671', 'cui_str': 'Universal (qualifier value)'}, {'cui': 'C0003826', 'cui_str': 'Arts'}]","[{'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0035182', 'cui_str': 'Residency'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0458074', 'cui_str': 'HIV status'}]",90.0,0.117108,"During the course of the trial, PVS increased significantly in both arms (23.5% to 46.2% in intervention, +22.8, p < 0.001; 26.0% to 44.6% in control, +18.6, p < 0.001).","[{'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Larmarange', 'Affiliation': 'Centre Population et Développement, Institut de Recherche pour le Développement, Université Paris Descartes, Inserm, Paris, France.'}, {'ForeName': 'Mamadou H', 'Initials': 'MH', 'LastName': 'Diallo', 'Affiliation': 'Centre Population et Développement, Institut de Recherche pour le Développement, Université Paris Descartes, Inserm, Paris, France.'}, {'ForeName': 'Nuala', 'Initials': 'N', 'LastName': 'McGrath', 'Affiliation': 'Africa Health Research Institute, School of Nursing and Public Health, University of KwaZulu-Natal, KwaZulu-Natal, South Africa.'}, {'ForeName': 'Collins', 'Initials': 'C', 'LastName': 'Iwuji', 'Affiliation': 'Africa Health Research Institute, KwaZulu-Natal, South Africa.'}, {'ForeName': 'Mélanie', 'Initials': 'M', 'LastName': 'Plazy', 'Affiliation': 'School of Public Health (ISPED), Inserm, Bordeaux Population Health Research Center, UMR 1219, Bordeaux University, Bordeaux, France.'}, {'ForeName': 'Rodolphe', 'Initials': 'R', 'LastName': 'Thiébaut', 'Affiliation': 'School of Public Health (ISPED), Inserm, Bordeaux Population Health Research Center, UMR 1219, Bordeaux University, Bordeaux, France.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Tanser', 'Affiliation': 'Africa Health Research Institute, School of Nursing and Public Health, University of KwaZulu-Natal, KwaZulu-Natal, South Africa.'}, {'ForeName': 'Till', 'Initials': 'T', 'LastName': 'Bärnighausen', 'Affiliation': 'Africa Health Research Institute, KwaZulu-Natal, South Africa.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Orne-Gliemann', 'Affiliation': 'School of Public Health (ISPED), Inserm, Bordeaux Population Health Research Center, UMR 1219, Bordeaux University, Bordeaux, France.'}, {'ForeName': 'Deenan', 'Initials': 'D', 'LastName': 'Pillay', 'Affiliation': 'Africa Health Research Institute, KwaZulu-Natal, South Africa.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Dabis', 'Affiliation': 'School of Public Health (ISPED), Inserm, Bordeaux Population Health Research Center, UMR 1219, Bordeaux University, Bordeaux, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of the International AIDS Society,['10.1002/jia2.25402'] 1277,31635976,Immunogenicity and safety of MF59-adjuvanted quadrivalent influenza vaccine versus standard and alternate B strain MF59-adjuvanted trivalent influenza vaccines in older adults.,"OBJECTIVE Evaluate whether adjuvanted quadrivalent influenza vaccine (aQIV) elicits a noninferior immune response compared with a licensed adjuvanted trivalent influenza vaccine (aTIV-1; Fluad™) and aTIV-2 containing an alternate B strain, examine whether aQIV had immunological superiority for the B strain absent from aTIV comparators, and evaluate reactogenicity and safety among adults ≥65 years. METHODS In a multicenter, double-blind, randomized controlled trial, adults ≥65 years were randomized 2:1:1 to vaccination with aQIV (n = 889), aTIV-1 (n = 445), or aTIV-2 (n = 444) during the 2017-2018 influenza season. Immunogenicity was assessed by hemagglutination inhibition (HI) assay conducted on serum samples collected before vaccination and 21 days after vaccination for homologous influenza strains. RESULTS aQIV met non-inferiority criteria for geometric mean titer ratios (GMT ratios) and seroconversion rate (SCR) differences against aTIV. The upper bounds of the 2-sided 95% confidence interval (CI) for GMT ratios were <1.5 for all 4 strains (A/H1N1 = 1.27, A/H3N2 = 1.09, B-Yamagata = 1.08, B-Victoria = 1.08). The upper bounds of the 95% CI of the SCR differences were <10% for all 4 strains (A/H1N1 = 7.76%, A/H3N2 = 4.96%, B-Yamagata = 3.27%, B-Victoria = 2.55%). aQIV also met superiority criteria (upper bound of 95% CI for GMT ratios <1 and SCR differences <0) for B strain absent from aTIV comparators (B-Yamagata GMT ratio = 0.70, SCR difference = -8.81%; B-Victoria GMT ratio = 0.78, SCR difference = -8.11%). aQIV and aTIV vaccines were immunogenic and well-tolerated. The immunological benefit of aQIV was also demonstrated in age subgroups 65-74 years, 75-84 years, and ≥85 years and in those with high comorbidity risk scores. Reactogenicity profiles were generally comparable. CONCLUSION aQIV induces a similar immune response as the licensed aTIV vaccine against homologous influenza strains and has a comparable reactogenicity and safety profile. Superior immunogenicity against the additional B strain was observed, indicating that aQIV could provide a broader protection than aTIV against influenza in older adults (NCT03314662).",2020,aQIV induces a similar immune response as the licensed aTIV vaccine against homologous influenza strains and has a comparable reactogenicity and safety profile.,"['adults ≥65\u202fyears', 'age subgroups 65-74\u202fyears, 75-84\u202fyears, and ≥85\u202fyears and in those with high comorbidity risk scores', 'older adults', 'n\u202f=\u202f889), aTIV-1 (n\u202f=\u202f445), or aTIV-2 (n\u202f=\u202f444) during the 2017-2018 influenza season']","['vaccination with aQIV', 'adjuvanted quadrivalent influenza vaccine (aQIV', 'MF59-adjuvanted quadrivalent influenza vaccine versus standard and alternate B strain MF59-adjuvanted trivalent influenza vaccines']","['reactogenicity and safety', 'Reactogenicity profiles', 'Immunogenicity and safety', 'GMT ratios', 'immunogenic and well-tolerated', 'Immunogenicity', 'geometric mean titer ratios (GMT ratios) and seroconversion rate (SCR) differences against aTIV', 'aQIV']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0021400', 'cui_str': 'Influenza, Human'}, {'cui': 'C0036497', 'cui_str': 'Seasons'}]","[{'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C4318638', 'cui_str': 'Quadrivalent Influenza Vaccine'}, {'cui': 'C0289787', 'cui_str': 'MF59'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0332270', 'cui_str': 'Alternating (qualifier value)'}, {'cui': 'C0080194', 'cui_str': 'Strains'}, {'cui': 'C0770694'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0475208', 'cui_str': 'TITR'}, {'cui': 'C4042908', 'cui_str': 'Seroconversion'}]",889.0,0.158036,aQIV induces a similar immune response as the licensed aTIV vaccine against homologous influenza strains and has a comparable reactogenicity and safety profile.,"[{'ForeName': 'Brandon', 'Initials': 'B', 'LastName': 'Essink', 'Affiliation': 'Meridian Clinical Research, Creighton, NE, USA. Electronic address: bessink@mcrmed.com.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Fierro', 'Affiliation': 'Johnson County Clin Trials, Lenexa, KS, USA. Electronic address: cfierro@jcct.com.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Rosen', 'Affiliation': 'Alliance of MultiSpeciality Research, Coral Gables, FL, USA. Electronic address: Jeffrey.Rosen@amrllc.com.'}, {'ForeName': 'Amparo L', 'Initials': 'AL', 'LastName': 'Figueroa', 'Affiliation': 'Clinical Vaccines, Seqirus Inc., Cambridge, MA, USA. Electronic address: amparo.figueroa@seqirus.com.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Zhang', 'Affiliation': 'Clinical Vaccines, Seqirus Inc., Cambridge, MA, USA. Electronic address: bin.zhang@seqirus.com.'}, {'ForeName': 'Carole', 'Initials': 'C', 'LastName': 'Verhoeven', 'Affiliation': 'Seqirus Netherlands BV, Amsterdam, the Netherlands. Electronic address: Carole.Verhoeven@Seqirus.com.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Edelman', 'Affiliation': 'Clinical Vaccines, Seqirus Inc., Cambridge, MA, USA. Electronic address: Jonathan.edelman@seqirus.com.'}, {'ForeName': 'Igor', 'Initials': 'I', 'LastName': 'Smolenov', 'Affiliation': 'Clinical Vaccines, Seqirus Inc., Cambridge, MA, USA. Electronic address: Igor.Smolenov@Seqirus.com.'}]",Vaccine,['10.1016/j.vaccine.2019.10.021'] 1278,31628698,"Efficacy and safety of cariprazine in bipolar I depression: A double-blind, placebo-controlled phase 3 study.","OBJECTIVE To assess the efficacy, safety, and tolerability of cariprazine in the treatment of the depressed phase of bipolar I disorder in adults (NCT02670538). METHODS In this phase 3 double-blind placebo-controlled study, adult patients with bipolar I disorder according to the Diagnostic and Statistical Manual - 5th Edition criteria and a current depressive episode were randomized to placebo (n = 167), cariprazine 1.5 mg/day (n = 168) or cariprazine 3.0 mg/day (n = 158). Efficacy parameters were changes in the Montgomery-Åsberg Depression Rating Scale (MADRS) total scores (primary) and Clinical Global Impressions - Severity (CGI-S) scores (secondary) from baseline to Week 6 compared to placebo. A mixed-model for repeated measures was used to estimate the least-squares mean differences (LSMD); P-values were adjusted for multiplicity. Adverse events (AEs), laboratory results, vital signs, and suicide risk were monitored. RESULTS Cariprazine 1.5 mg/day significantly reduced depressive symptoms on the primary (MADRS LSMD = -2.5; adjusted P = .0417) and secondary (CGI-S LSMD = -0.3; adjusted P = .0417) efficacy parameters vs placebo; differences were not statistically significant for cariprazine 3.0 mg/day. Common treatment-emergent AEs (≥5% in either cariprazine group and at least twice the incidence of placebo) were akathisia, restlessness, nausea, and fatigue. Mean metabolic parameter changes were low and generally comparable among groups; mean weight increases were ≤0.5 kg for all groups. CONCLUSIONS Cariprazine 1.5 mg/day significantly reduced depressive symptoms in adults with bipolar I depression compared to placebo, but differences were not significant for cariprazine 3.0 mg/day. The safety and tolerability profiles were similar to previous studies of cariprazine.",2020,"Mean metabolic parameter changes were low and generally comparable among groups; mean weight increases were ≤0.5 kg for all groups. ","['adult patients with bipolar I disorder according to the Diagnostic and Statistical Manual - 5 th Edition criteria and a current depressive episode', 'bipolar I depression']","['placebo', 'cariprazine 1.5 mg/day[d', 'Cariprazine', 'cariprazine']","['depressive symptoms', 'safety and tolerability profiles', 'Mean metabolic parameter changes', 'akathisia, restlessness, nausea, and fatigue', 'mean weight increases', 'Montgomery-Åsberg Depression Rating Scale (MADRS) total scores (primary) and Clinical Global Impressions - Severity (CGI-S) scores', 'Adverse events (AEs), laboratory results, vital signs, and suicide risk', 'Efficacy and safety', 'efficacy, safety, and tolerability']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0853193', 'cui_str': 'Bipolar I disorder (disorder)'}, {'cui': 'C0348026', 'cui_str': 'Diagnostic'}, {'cui': 'C0175674', 'cui_str': 'Manual (qualifier value)'}, {'cui': 'C0441792', 'cui_str': 'Editions (qualifier value)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0349217', 'cui_str': 'Depressive episode'}, {'cui': 'C0443156', 'cui_str': 'Bipolar (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4056789', 'cui_str': 'cariprazine 1.5 MG'}, {'cui': 'C2936870', 'cui_str': 'cariprazine'}]","[{'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0392156', 'cui_str': 'Akathisia'}, {'cui': 'C0542200', 'cui_str': 'Restlessness (phenothiazine)'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0043094', 'cui_str': 'Weight Gain'}, {'cui': 'C2960593', 'cui_str': 'Montgomery-Åsberg depression rating scale'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0518766'}, {'cui': 'C0563664', 'cui_str': 'Suicide risk'}]",,0.20525,"Mean metabolic parameter changes were low and generally comparable among groups; mean weight increases were ≤0.5 kg for all groups. ","[{'ForeName': 'Willie R', 'Initials': 'WR', 'LastName': 'Earley', 'Affiliation': 'Department of Clinical Development, Allergan plc, Madison, NJ, USA.'}, {'ForeName': 'Maria V', 'Initials': 'MV', 'LastName': 'Burgess', 'Affiliation': 'Department of Clinical Development, Allergan plc, Madison, NJ, USA.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Khan', 'Affiliation': 'Department of Clinical Development, Allergan plc, Madison, NJ, USA.'}, {'ForeName': 'Ludmyla', 'Initials': 'L', 'LastName': 'Rekeda', 'Affiliation': 'Department of Biostatistics, Allergan plc, Madison, NJ, USA.'}, {'ForeName': 'Trisha', 'Initials': 'T', 'LastName': 'Suppes', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine and V.A. Palo Alto Health Care System, Palo Alto, CA, USA.'}, {'ForeName': 'Mauricio', 'Initials': 'M', 'LastName': 'Tohen', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of New Mexico, Albuquerque, NM, USA.'}, {'ForeName': 'Joseph R', 'Initials': 'JR', 'LastName': 'Calabrese', 'Affiliation': 'Department of Psychiatry, Case Western Reserve School of Medicine, Cleveland, OH, USA.'}]",Bipolar disorders,['10.1111/bdi.12852'] 1279,29460712,Rhythmic low-field magnetic stimulation may improve depression by increasing brain-derived neurotrophic factor.,"BACKGROUND Low-field magnetic stimulation (LFMS) has mood-elevating effect, and the increase of brain-derived neurotrophic factor (BDNF) is associated with antidepressant treatment. We evaluated the effects and association with BDNF of rhythmic LFMS in the treatment of major depressive disorder (MDD). METHODS A total of 22 MDD patients were randomized to rhythmic alpha stimulation (RAS) or rhythmic delta stimulation (RDS), with 5 sessions per week, lasting for 6 weeks. Outcomes assessments included the 17-item Hamilton Depression Rating Scale (HAMD-17), the Hamilton Anxiety Rating Scale (HAMA), and the Clinical Global Impressions-Severity scale (CGI-S) at baseline and at weeks 1, 2, 3, 4, and 6. Serum BDNF level was measured at baseline and at weeks 2, 4, and 6. RESULTS HAMD-17, HAMA, and CGI-S scores were significantly reduced with both RAS and RDS. RAS patients had numerically greater reductions in HAMD-17 scores than RDS patients (8.9 ± 7.4 vs. 6.2 ± 6.2, effect size [ES]=0.40), while RDS patients had greater improvement in HAMA scores (8.2 ± 8.0 vs. 5.3 ± 5.8, ES=0.42). RAS was associated with clinically relevant advantages in response (54.5% vs. 18.2%, number-needed-to-treat [NNT]=3) and remission (36.4% vs. 9.1%, NNT=4). BDNF increased significantly during the 6-week study period (p<0.05), with greater increases in RAS at weeks 4 and 6 (ES=0.66-0.76) and statistical superiority at week 2 (p=0.034, ES=1.23). Baseline BDNF in the 8 responders (24.8±9.0 ng/ml) was lower than in the 14 nonresponders (31.1±7.3 ng/ml, p=0.083, ES=-0.79), and BDNF increased more in responders (8.9±7.8 ng/ml) than in nonresponders (1.8±3.5 ng/ml, p=0.044). The change in BDNF at week 2 was the most strongly predicted response (p=0.016). CONCLUSIONS Rhythmic LFMS was effective for MDD. BDNF may moderate/mediate the efficacy of LFMS.",2019,"RESULTS HAMD-17, HAMA, and CGI-S scores were significantly reduced with both RAS and RDS.","['major depressive disorder (MDD', '22 MDD patients']","['rhythmic alpha stimulation (RAS) or rhythmic delta stimulation (RDS', 'BDNF of rhythmic LFMS', 'Rhythmic low-field magnetic stimulation', 'Low-field magnetic stimulation (LFMS']","['HAMD-17 scores', 'BDNF', 'RAS', 'HAMD-17, HAMA, and CGI-S scores', '17-item Hamilton Depression Rating Scale (HAMD-17), the Hamilton Anxiety Rating Scale (HAMA), and the Clinical Global Impressions-Severity scale (CGI-S', 'HAMA scores', 'Baseline BDNF', 'change in BDNF', 'Serum BDNF level']","[{'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0439097', 'cui_str': 'Delta'}, {'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0440042', 'cui_str': ""Field's""}, {'cui': 'C0024488', 'cui_str': 'Magnetics'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0222045'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",22.0,0.101256,"RESULTS HAMD-17, HAMA, and CGI-S scores were significantly reduced with both RAS and RDS.","[{'ForeName': 'Le', 'Initials': 'L', 'LastName': 'Xiao', 'Affiliation': '1The National Clinical Research Center for Mental Disorders and Beijing Key Laboratory of Mental Disorders,Beijing Anding Hospital,Capital Medical University,Beijing,China.'}, {'ForeName': 'Christoph U', 'Initials': 'CU', 'LastName': 'Correll', 'Affiliation': '2Department of Psychiatry,The Zucker Hillside Hospital,Northwell Health,Glen Oaks,New York,United States.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Feng', 'Affiliation': '1The National Clinical Research Center for Mental Disorders and Beijing Key Laboratory of Mental Disorders,Beijing Anding Hospital,Capital Medical University,Beijing,China.'}, {'ForeName': 'Yu-Tao', 'Initials': 'YT', 'LastName': 'Xiang', 'Affiliation': '3Unit of Psychiatry, Faculty of Health Sciences,University of Macau,Macao SAR,China.'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Feng', 'Affiliation': '1The National Clinical Research Center for Mental Disorders and Beijing Key Laboratory of Mental Disorders,Beijing Anding Hospital,Capital Medical University,Beijing,China.'}, {'ForeName': 'Chang-Qing', 'Initials': 'CQ', 'LastName': 'Hu', 'Affiliation': '1The National Clinical Research Center for Mental Disorders and Beijing Key Laboratory of Mental Disorders,Beijing Anding Hospital,Capital Medical University,Beijing,China.'}, {'ForeName': 'Rena', 'Initials': 'R', 'LastName': 'Li', 'Affiliation': '1The National Clinical Research Center for Mental Disorders and Beijing Key Laboratory of Mental Disorders,Beijing Anding Hospital,Capital Medical University,Beijing,China.'}, {'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Wang', 'Affiliation': '1The National Clinical Research Center for Mental Disorders and Beijing Key Laboratory of Mental Disorders,Beijing Anding Hospital,Capital Medical University,Beijing,China.'}]",CNS spectrums,['10.1017/S1092852917000670'] 1280,29528960,Knee Kinetics During Squats of Varying Loads and Depths in Recreationally Trained Women.,"Flores, V, Becker, J, Burkhardt, E, and Cotter, J. Knee kinetics during squats of varying loads and depths in recreationally trained women. J Strength Cond Res 34(7): 1945-1952, 2020-The back squat exercise is typically practiced with varying squat depths and barbell loads. However, depth has been inconsistently defined, resulting in unclear safety precautions when squatting with loads. In addition, women exhibit anatomical and kinematic differences to men, which may predispose them to knee joint injuries. The purpose of this study was to characterize peak knee extensor moments (pKEMs) at 3 commonly practiced squat depths of above-parallel, parallel, and full depths, and with 3 loads of 0 (unloaded), 50, and 85% depth-specific 1 repetition maximum (1RM) in recreationally active women. Nineteen women (age, 25.1 ± 5.8 years; body mass, 62.5 ± 10.2 kg; height, 1.6 ± 0.10 m; mean ± SD) performed squats of randomized depth and load. Inverse dynamics were used to obtain pKEMs from 3-dimensional knee kinematics. Depth and load had significant interaction effects on pKEMs (p = 0.014). Significantly greater pKEMs were observed at full depth compared with parallel depth with 50% 1RM load (p = 0.001, d = 0.615) and 85% 1RM load (p = 0.010, d = 0.714). Greater pKEMs were also observed at full depth compared with above-parallel depth with 50% 1RM load (p = 0.003, d = 0.504). Results indicate that effect of load on female pKEMs do not follow a progressively increasing pattern with either increasing depth or load. Therefore, when high knee loading is a concern, individuals must carefully consider both the depth of squat being performed and the relative load they are using.",2020,"Significantly greater pKEMs were observed at full depth compared to parallel depth with 50% 1RM load (p = 0.001, d = 0.615), and 85% 1RM load (p = 0.010, d = 0.714).","['Nineteen females (age, 25.1 ± 5.8 years; body mass, 62.5 ± 10.2 kg; height, 1.6 ± 0.10 m; mean ± SD) performed squats of randomized depth and load', 'Recreationally Trained Females']",['back squat exercise'],['peak knee extensor moments (pKEMs'],"[{'cui': 'C0450337', 'cui_str': '19 (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517796', 'cui_str': '5.8'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C4517836', 'cui_str': '62.5'}, {'cui': 'C4517508', 'cui_str': '1.6 (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0241236', 'cui_str': 'Does squat (finding)'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}]","[{'cui': 'C0241236', 'cui_str': 'Does squat (finding)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}]",,0.114981,"Significantly greater pKEMs were observed at full depth compared to parallel depth with 50% 1RM load (p = 0.001, d = 0.615), and 85% 1RM load (p = 0.010, d = 0.714).","[{'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Flores', 'Affiliation': 'Department of Kinesiology, California State University, Long Beach, California.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Becker', 'Affiliation': 'College of Education, Health, and Human Development, Montana State University, Bozeman, Montana.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Burkhardt', 'Affiliation': 'Department of Kinesiology, California State University, Long Beach, California.'}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Cotter', 'Affiliation': 'Department of Kinesiology, California State University, Long Beach, California.'}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000002509'] 1281,29470308,EFFICACY AND SAFETY OUTCOMES OF INTRAVITREAL AFLIBERCEPT FOCUSING ON PATIENTS WITH DIABETIC MACULAR EDEMA FROM JAPAN.,"PURPOSE To evaluate the efficacy and safety of intravitreal aflibercept injection (IAI) in Japanese patients with diabetic macular edema (DME). METHODS VIVID-DME was a Phase 3 study comprising patients with DME randomized 1:1:1 to IAI 2 mg every 4 weeks (2q4), IAI 2 mg every 4 weeks until Week 16 then 8-week dosing (2q8), and laser. A total of 403 patients (76 Japanese) were included in this study. VIVID-Japan (72; all Japanese patients) was a nonrandomized, open-label study comprising Japanese patients with DME receiving IAI 2q4 until Week 16, then 2q8. Primary efficacy endpoint (Week 52) of VIVID-DME was mean change from baseline in best-corrected visual acuity; VIVID-Japan evaluated safety and tolerability. RESULTS Mean change in best-corrected visual acuity (letters) for 2q4, 2q8, and laser groups was +10.6, +10.9, and +1.2 and +9.8, +9.5, and +1.1 in the non-Japanese and Japanese populations of VIVID-DME, respectively. In VIVID-Japan, it was +9.3 for IAI 2q8. Intravitreal aflibercept injection also provided consistently greater benefits for anatomical outcomes versus laser. Adverse events were consistent with the known safety profile of IAI. CONCLUSION In Japanese patients with DME, IAI treatment was superior to laser for visual and anatomical outcomes and resulted in efficacy and safety outcomes similar to those in a non-Japanese patient population.",2019,"In Japanese patients with DME, IAI treatment was superior to laser for visual and anatomical outcomes and resulted in efficacy and safety outcomes similar to those in a non-Japanese patient population.","['Japanese patients with DME', 'VIVID-Japan (72; all Japanese patients', 'Japanese patients with diabetic macular edema (DME', 'VIVID-DME was a Phase 3 study comprising patients with DME', 'Japanese patients with DME receiving IAI 2q4 until Week 16, then 2q8', '403 patients (76 Japanese']","['VIVID-DME', 'intravitreal aflibercept injection (IAI', 'Intravitreal aflibercept injection']","['Adverse events', 'safety and tolerability', 'efficacy and safety outcomes', 'efficacy and safety', 'Mean change in best-corrected visual acuity (letters']","[{'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0641456', 'cui_str': 'DMES'}, {'cui': 'C1268943', 'cui_str': 'Vivid'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0730285', 'cui_str': 'Diabetic macular edema'}, {'cui': 'C1292718', 'cui_str': 'Is a'}, {'cui': 'C0439561', 'cui_str': 'Phase 3 (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C1268943', 'cui_str': 'Vivid'}, {'cui': 'C0641456', 'cui_str': 'DMES'}, {'cui': 'C4050106', 'cui_str': 'aflibercept Injection'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C1690532', 'cui_str': 'Best corrected visual acuity'}, {'cui': 'C1096774', 'cui_str': 'Letter'}]",403.0,0.0208487,"In Japanese patients with DME, IAI treatment was superior to laser for visual and anatomical outcomes and resulted in efficacy and safety outcomes similar to those in a non-Japanese patient population.","[{'ForeName': 'Hiroko', 'Initials': 'H', 'LastName': 'Terasaki', 'Affiliation': 'Department of Ophthalmology, Nagoya University Hospital, Nagoya, Japan.'}, {'ForeName': 'Kunihiko', 'Initials': 'K', 'LastName': 'Shiraki', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, Osaka City University, Osaka, Japan.'}, {'ForeName': 'Masahito', 'Initials': 'M', 'LastName': 'Ohji', 'Affiliation': 'Department of Ophthalmology, Shiga University of Medical Science, Otsu, Japan.'}, {'ForeName': 'Carola', 'Initials': 'C', 'LastName': 'Metzig', 'Affiliation': 'Bayer AG, Berlin, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Schmelter', 'Affiliation': 'Bayer AG, Berlin, Germany.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Zeitz', 'Affiliation': 'Bayer AG, Berlin, Germany.'}, {'ForeName': 'Olaf', 'Initials': 'O', 'LastName': 'Sowade', 'Affiliation': 'Bayer AG, Berlin, Germany.'}, {'ForeName': 'Masato', 'Initials': 'M', 'LastName': 'Kobayashi', 'Affiliation': 'Bayer Pharmaceuticals, Osaka, Japan.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Vitti', 'Affiliation': 'Regeneron Pharmaceuticals, Tarrytown, New York.'}, {'ForeName': 'Alyson', 'Initials': 'A', 'LastName': 'Berliner', 'Affiliation': 'Regeneron Pharmaceuticals, Tarrytown, New York.'}, {'ForeName': 'Fumio', 'Initials': 'F', 'LastName': 'Shiraga', 'Affiliation': 'Department of Ophthalmology, Okayama University Medical School, Okayama, Japan.'}]","Retina (Philadelphia, Pa.)",['10.1097/IAE.0000000000002100'] 1282,29425923,Effects of Training and Feedback on Accuracy of Predicting Rectosigmoid Neoplastic Lesions and Selection of Surveillance Intervals by Endoscopists Performing Optical Diagnosis of Diminutive Polyps.,"BACKGROUND & AIMS Real-time differentiation of diminutive polyps (1-5 mm) during endoscopy could replace histopathology analysis. According to guidelines, implementation of optical diagnosis into routine practice would require it to identify rectosigmoid neoplastic lesions with a negative predictive value (NPV) of more than 90%, using histologic findings as a reference, and agreement with histology-based surveillance intervals for more than 90% of cases. METHODS We performed a prospective study with 39 endoscopists accredited to perform colonoscopies on participants with positive results from fecal immunochemical tests in the Bowel Cancer Screening Program at 13 centers in the Netherlands. Endoscopists were trained in optical diagnosis using a validated module (Workgroup serrAted polypS and Polyposis). After meeting predefined performance thresholds in the training program, the endoscopists started a 1-year program (continuation phase) in which they performed narrow band imaging analyses during colonoscopies of participants in the screening program and predicted histological findings with confidence levels. The endoscopists were randomly assigned to groups that received feedback or no feedback on the accuracy of their predictions. Primary outcome measures were endoscopists' abilities to identify rectosigmoid neoplastic lesions (using histology as a reference) with NPVs of 90% or more, and selecting surveillance intervals that agreed with those determined by histology for at least 90% of cases. RESULTS Of 39 endoscopists initially trained, 27 (69%) completed the training program. During the continuation phase, these 27 endoscopists performed 3144 colonoscopies in which 4504 diminutive polyps were removed. The endoscopists identified neoplastic lesions with a pooled NPV of 90.8% (95% confidence interval 88.6-92.6); their proposed surveillance intervals agreed with those determined by histologic analysis for 95.4% of cases (95% confidence interval 94.0-96.6). Findings did not differ between the group that did vs did not receive feedback. Sixteen endoscopists (59%) identified rectosigmoid neoplastic lesions with NPVs greater than 90% and selected surveillance intervals in agreement with those determined from histology for more than 90% of patients. CONCLUSIONS In a prospective study following a validated training module, we found that a selected group of endoscopists identified rectosigmoid neoplastic lesions with pooled NPVs greater than 90% and accurately selected surveillance intervals for more than 90% of patients over the course of 1 year. Providing regular interim feedback on the accuracy of neoplastic lesion prediction and surveillance interval selection did not lead to differences in those endpoints. Monitoring is suggested, as individual performance varied. ClinicalTrials.gov no: NCT02516748; Netherland Trial Register: NTR4635.",2018,Providing regular interim feedback on the accuracy of neoplastic lesion prediction and surveillance interval selection did not lead to differences in those endpoints.,"['39 endoscopists accredited to perform colonoscopies on participants with positive results from fecal immunochemical tests in the Bowel Cancer Screening Program at 13 centers in the Netherlands', '27 endoscopists performed 3144 colonoscopies in which 4504 diminutive polyps were removed', 'selected group of endoscopists identified rectosigmoid neoplastic lesions with pooled NPVs greater than 90% and accurately selected surveillance intervals for more than 90% of patients over the course of 1 year']","['Training and Feedback', 'feedback or no feedback']","['rectosigmoid neoplastic lesions', ""endoscopists' abilities to identify rectosigmoid neoplastic lesions (using histology as a reference) with NPVs of 90% or more, and selecting surveillance intervals""]","[{'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0009378', 'cui_str': 'Endoscopy of colon'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0346627', 'cui_str': 'Cancer of Intestines'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0032584', 'cui_str': 'Polyp (morphologic abnormality)'}, {'cui': 'C1883720', 'cui_str': 'Removes'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0521377', 'cui_str': 'Rectum and sigmoid colon, CS'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0337051', 'cui_str': 'Pool (environment)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0733511', 'cui_str': 'Surveillance (regime/therapy)'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0750729', 'cui_str': 'Courses (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}]","[{'cui': 'C0521377', 'cui_str': 'Rectum and sigmoid colon, CS'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0344441', 'cui_str': 'Histologic test (procedure)'}, {'cui': 'C0733511', 'cui_str': 'Surveillance (regime/therapy)'}, {'cui': 'C1272706', 'cui_str': 'Interval'}]",,0.0629056,Providing regular interim feedback on the accuracy of neoplastic lesion prediction and surveillance interval selection did not lead to differences in those endpoints.,"[{'ForeName': 'Jasper L A', 'Initials': 'JLA', 'LastName': 'Vleugels', 'Affiliation': 'Department of Gastroenterology and Hepatology, Academic Medical Centre, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Marcel G W', 'Initials': 'MGW', 'LastName': 'Dijkgraaf', 'Affiliation': 'Department of Clinical Epidemiology, Biostatistics and Bioinformatics, Academic Medical Centre, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Yark', 'Initials': 'Y', 'LastName': 'Hazewinkel', 'Affiliation': 'Department of Gastroenterology and Hepatology, Academic Medical Centre, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Linda K', 'Initials': 'LK', 'LastName': 'Wanders', 'Affiliation': 'Department of Gastroenterology and Hepatology, Academic Medical Centre, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Fockens', 'Affiliation': 'Department of Gastroenterology and Hepatology, Academic Medical Centre, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Evelien', 'Initials': 'E', 'LastName': 'Dekker', 'Affiliation': 'Department of Gastroenterology and Hepatology, Academic Medical Centre, University of Amsterdam, Amsterdam, the Netherlands. Electronic address: e.dekker@amc.uva.nl.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Gastroenterology,['10.1053/j.gastro.2018.01.063'] 1283,31899170,Cost-Effectiveness of Three Doses of a Behavioral Intervention to Prevent or Delay Type 2 Diabetes in Rural Areas.,"BACKGROUND Rural Americans have higher prevalence of obesity and type 2 diabetes (T2D) than urban populations and more limited access to behavioral programs to promote healthy lifestyle habits. Descriptive evidence from the Rural Lifestyle Intervention Treatment Effectiveness trial delivered through local cooperative extension service offices in rural areas previously identified that behavioral modification with both nutrition education and coaching resulted in a lower program delivery cost per kilogram of weight loss maintained at 2-years compared with an education-only comparator intervention. OBJECTIVE This analysis extended earlier Rural Lifestyle Intervention Treatment Effectiveness trial research regarding weight loss outcomes to assess whether nutrition education with behavioral coaching delivered through cooperative extension service offices is cost-effective relative to nutrition education only in reducing T2D cases in rural areas. DESIGN A cost-utility analysis was conducted. PARTICIPANTS/SETTING Trial participants (n=317) from June 2008 through June 2014 were adults residing in rural Florida counties with a baseline body mass index between 30 and 45, but otherwise identified as healthy. INTERVENTION Trial participants were randomly assigned to low, moderate, or high doses of behavioral coaching with nutrition education (ie, 16, 32, or 48 sessions over 24 months) or a comparator intervention that included 16 sessions of nutrition education without coaching. Participant glycated hemoglobin level was measured at baseline and the end of the trial to assess T2D status. MAIN OUTCOME MEASURES T2D categories by treatment arm were used to estimate participants' expected annual health care expenditures and expected health-related utility measured as quality adjusted life years (ie, QALYs) over a 5-year time horizon. Discounted incremental costs and QALYs were used to calculate incremental cost-effectiveness ratios for each behavioral coaching intervention dose relative to the education-only comparator. STATISTICAL ANALYSES PERFORMED Using a third-party payer perspective, Markov transition matrices were used to model participant transitions between T2D states. Replications of the individual participant behavior were conducted using Monte Carlo simulation. RESULTS All three doses of the behavioral coaching intervention had lower expected total costs and higher estimated QALYs than the education-only comparator. The moderate dose behavioral coaching intervention was associated with higher estimated QALYs but was costlier than the low dose; the moderate dose was favored over the low dose with willingness to pay thresholds over $107,895/QALY. The low dose behavioral coaching intervention was otherwise favored. CONCLUSIONS Because most rural Americans live in counties with cooperative extension service offices, nutrition education with behavioral coaching programs similar to those delivered through this trial may be effective and efficient in preventing or delaying T2D-associated consequences of obesity for rural adults.",2020,All three doses of the behavioral coaching intervention had lower expected total costs and higher estimated QALYs than the education-only comparator.,"['T2D cases in rural areas', 'rural Americans live in counties with cooperative extension service offices', 'Rural Americans', 'Delay Type 2 Diabetes in Rural Areas', 'Trial participants (n=317) from June 2008 through June 2014 were adults residing in rural Florida counties with a baseline body mass index between 30 and 45, but otherwise identified as healthy', 'rural adults']","['comparator intervention that included 16 sessions of nutrition education without coaching', 'behavioral coaching intervention', 'behavioral coaching with nutrition education', 'Behavioral Intervention']","['annual health care expenditures and expected health-related utility measured as quality adjusted life years (ie, QALYs) over a 5-year time horizon', 'total costs', 'Participant glycated hemoglobin level', 'Cost-Effectiveness']","[{'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0442603', 'cui_str': 'Office (environment)'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0016253', 'cui_str': 'Florida'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}]","[{'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0204934', 'cui_str': 'Nutritional education'}, {'cui': 'C0557773', 'cui_str': 'Coach (physical object)'}]","[{'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C0015316', 'cui_str': 'Expenditures'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0080071', 'cui_str': 'QALY'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0017853', 'cui_str': 'Hemoglobin, Glycosylated'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}]",2014.0,0.0572379,All three doses of the behavioral coaching intervention had lower expected total costs and higher estimated QALYs than the education-only comparator.,"[{'ForeName': 'Tiffany A', 'Initials': 'TA', 'LastName': 'Radcliff', 'Affiliation': ''}, {'ForeName': 'Murray J', 'Initials': 'MJ', 'LastName': 'Côté', 'Affiliation': ''}, {'ForeName': 'Melanie D', 'Initials': 'MD', 'LastName': 'Whittington', 'Affiliation': ''}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Daniels', 'Affiliation': ''}, {'ForeName': 'Linda B', 'Initials': 'LB', 'LastName': 'Bobroff', 'Affiliation': ''}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Janicke', 'Affiliation': ''}, {'ForeName': 'Michael G', 'Initials': 'MG', 'LastName': 'Perri', 'Affiliation': ''}]",Journal of the Academy of Nutrition and Dietetics,['10.1016/j.jand.2019.10.025'] 1284,29570574,Sequencing Effects of Plyometric Training Applied Before or After Regular Soccer Training on Measures of Physical Fitness in Young Players.,"Ramirez-Campillo, R, Alvarez, C, Gentil, P, Loturco, I, Sanchez-Sanchez, J, Izquierdo, M, Moran, J, Nakamura, FY, Chaabene, H, and Granacher, U. Sequencing effects of plyometric training applied before or after regular soccer training on measures of physical fitness in young players. J Strength Cond Res 34(7): 1959-1966, 2020-To compare the effects of short-term (i.e., 7 weeks) plyometric jump training applied before (PJT-B) or after (PJT-A) soccer practice on components of physical fitness in young soccer players, a single-blind randomized controlled trial was conducted. Postpubertal boys aged 17.0 ± 0.5 years were allocated to 3 groups: PJT-B (n = 12), PJT-A (n = 14), and control (CON; n = 12). The outcome measures included tests to evaluate 20-m speed, standing long jump (SLJ), squat jump (SJ), countermovement jump (CMJ), and drop jump (DJ), 20-m multistage shuttle run endurance (MSSRT), and Illinois change-of-direction speed (ICODT). Although the CON performed soccer-specific training, the PJT-A and PJT-B groups conducted the same soccer-specific sessions but replaced ∼11% of their time with plyometric training. The PJT-B group performed plyometric exercises after a warm-up program, and the PJT-A group conducted plyometric exercises ∼10 minutes after the completion of soccer training. Analyses of variance were used to detect differences between groups in all variables for pretraining and posttraining tests. Main effects of time (all p < 0.01; d = 0.19-0.79) and group × time interactions (all p ≤ 0.05; d = 0.17-0.76) were observed for all examined variables. Post hoc analyses revealed significant increases in the PJT-B group (SLJ: 9.4%, d = 1.7; CMJ: 11.2%, d = 0.75; 20-m MSSRT: 9.0%, d = 0.77) and the PJT-A group (SLJ: 3.1%, d = 0.7; CMJ: 4.9%, d = 0.27; 20-m MSSRT: 9.0%, d = 0.76). Post hoc analyses also revealed significant increases in the PJT-B group (20-m speed: -7.4%, d = 0.75; 20-cm DJ reactive strength index: 19.1%, d = 1.4; SJ: 6.3%, d = 0.44; ICODT results: -4.2%, d = 1.1). In general, our study revealed that plyometric training is effective in improving measures of physical fitness in young male soccer players when combined with regular soccer training. More specifically, larger training-induced effects on physical fitness were registered if plyometric training was conducted before soccer-specific training.",2020,Main effects of time (all p<.01; d=0.19-0.79) and group x time interactions (all p<.05; d=0.17-0.76) were observed for all examined variables.,"['Young Players', 'Post-pubertal boys aged 17.0±0.5 years', 'young soccer players', 'young male soccer players']","['plyometric training', 'PJT-A group conducted plyometric exercises ∼10 minutes after the completion of soccer training', 'plyometric exercises', 'Plyometric Training Applied Before or After Regular Soccer Training', 'plyometric training applied before (PJT-B) or after (PJT-A) soccer practice']","['physical fitness', 'Physical Fitness', 'tests to evaluate 20-m speed, standing long jump [SLJ], squat jump [SJ], countermovement jump [CMJ], and drop jump [DJ], 20-m multistage shuttle running speed [MSSRT], and Illinois change of direction speed [ICODT', '20-cm DJ reactive strength index']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C1626404', 'cui_str': 'Post-pubertal'}, {'cui': 'C0870221', 'cui_str': 'Boys'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0037393', 'cui_str': 'Soccers'}, {'cui': 'C0086582', 'cui_str': 'Males'}]","[{'cui': 'C3178799', 'cui_str': 'Plyometric Training'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0037393', 'cui_str': 'Soccers'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0205272', 'cui_str': 'Regular (qualifier value)'}]","[{'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C3888057', 'cui_str': 'Stand'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0560453', 'cui_str': 'Does jump (finding)'}, {'cui': 'C0241236', 'cui_str': 'Does squat (finding)'}, {'cui': 'C4318619', 'cui_str': 'Drop (unit of presentation)'}, {'cui': 'C0600140', 'cui_str': 'Does run (finding)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0439755', 'cui_str': 'Directions (qualifier value)'}, {'cui': 'C0205332', 'cui_str': 'Reactive (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",,0.012117,Main effects of time (all p<.01; d=0.19-0.79) and group x time interactions (all p<.05; d=0.17-0.76) were observed for all examined variables.,"[{'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Ramirez-Campillo', 'Affiliation': 'Department of Physical Activity Sciences, Research Nucleus in Health, Physical Activity and Sport, Universidad de Los (University of Los Lagos), Lagos, Osorno, Chile.'}, {'ForeName': 'Cristian', 'Initials': 'C', 'LastName': 'Alvarez', 'Affiliation': 'Department of Physical Activity Sciences, Research Nucleus in Health, Physical Activity and Sport, Universidad de Los (University of Los Lagos), Lagos, Osorno, Chile.'}, {'ForeName': 'Paulo', 'Initials': 'P', 'LastName': 'Gentil', 'Affiliation': 'College of Physical Education and Dance, Federal University of Goias, Goiânia, Brazil.'}, {'ForeName': 'Irineu', 'Initials': 'I', 'LastName': 'Loturco', 'Affiliation': 'Nucleus of High Performance in Sport (NAR), São Paulo, Brazil.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Sanchez-Sanchez', 'Affiliation': 'Research Group Planning and Assessment of Training and Athletic Performance, Pontifical University of Salamanca, Salamanca, Spain.'}, {'ForeName': 'Mikel', 'Initials': 'M', 'LastName': 'Izquierdo', 'Affiliation': 'Department of Health Sciences, Public University of Navarre, Navarra, Spain.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Moran', 'Affiliation': 'Department of Sport, University Center Hartpury, University of the West of England, Bristol, United Kingdom.'}, {'ForeName': 'Fabio Y', 'Initials': 'FY', 'LastName': 'Nakamura', 'Affiliation': 'The College of Healthcare Sciences, James Cook University, Queensland, Australia.'}, {'ForeName': 'Helmi', 'Initials': 'H', 'LastName': 'Chaabene', 'Affiliation': 'High Institute of Sports and Physical Education, University of Jendouba, El Kef, Tunisia.'}, {'ForeName': 'Urs', 'Initials': 'U', 'LastName': 'Granacher', 'Affiliation': 'Division of Training and Movement Sciences, Research Focus Cognition Sciences, University of Potsdam, Potsdam, Germany.'}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000002525'] 1285,29461420,"Effect of Ibuprofen on Muscle, Hematological and Renal Function, Hydric Balance, Pain, and Performance During Intense Long-Distance Running.","de Souza, RF, de Matos, DG, Ferreira, ARP, Chilibeck, P, Barros, NdA, de Oliveira, AS, Cercato, LM, da Silva, DS, and Aidar, FJ. Effect of ibuprofen on muscle, hematological and renal function, hydric balance, pain, and performance during intense long-distance running. J Strength Cond Res 34(7): 2076-2083, 2020-The aim of this study was to investigate the effect of prophylactic use of nonsteroidal anti-inflammatory drugs (i.e., ibuprofen) on physical performance, vertical jump, muscle biomarkers, liver, kidney, acute pain, and hydration status of participants in the 42-km Trail Running Challenge, a long-distance race integrated over mountain routes. The sample consisted of 20 men randomly divided into 2 groups: a control group (CG) and an experimental group (EG), with 12 completing the race (41.1 ± 8.8 years; 75.7 ± 12.1 kg) and included in the final analysis. The EG were administered an ibuprofen capsule (400 mg) 15 minutes before the beginning of the race and again after 5 hours of racing if the route was not yet completed. There were significant time main effects for creatine kinase (p = 0.001; f Cohen = 0.25), lactate dehydrogenase (p < 0.001; f Cohen = 2.05), aspartate aminotransferase (p = 0.002; f Cohen = 1.53), creatinine (p = 0.002; f Cohen = 2.24), urea (p = 0.001; f Cohen = 2.25), heart rate (p < 0.001; f Cohen = 4.88), and pain scores (p < 0.001; f Cohen = 1.93) all of which increased during the race. There was a group × time interaction for squat jump, which significantly decreased only in the CG (p = 0.045; f Cohen = 2.17). This may have been related to increased frequency of pain reported after the race in the gastrocnemius of the CG compared with the EG (p ≤ 0.05). It was concluded that ibuprofen intake did not reduce muscle damage during the competition but maintained leg muscular power performance (i.e., vertical jump), possibly by reducing gastrocnemius muscle pain.",2020,"There were significant time main effects for creatine kinase (CK) (p=0.001; f Cohen=0.25), lactate dehydrogenase (LDH) (p<0.001; f Cohen=2.05), aspartate aminotransferase (AST) (p=0.002; f Cohen=1.53), creatinine (p=0.002; f Cohen=2.24), urea (p=0.001; f Cohen=2.25), heart rate (HR) (p<0.001; f Cohen=4.88) and pain scores (p<0.001; f Cohen=1.93) which all increased during the race.","['participants in the 42 km Trail Running Challenge, a long-distance race integrated over mountain routes']","['nonsteroidal anti-inflammatory drugs (NSAID, i.e. Ibuprofen', 'ibuprofen capsule', 'ibuprofen', 'control group (CG']","['gastrocnemius muscle pain', 'time interaction for squat jump (SJ', 'creatine kinase (CK', 'heart rate (HR', 'muscle, hematological and renal function, hydric balance, pain, and performance during intense long-distance running', 'pain scores', 'physical performance, vertical jump, muscle biomarkers, liver, kidney, acute pain and hydration status', 'lactate dehydrogenase (LDH', 'aspartate aminotransferase (AST']","[{'cui': 'C0600140', 'cui_str': 'Does run (finding)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C3853635', 'cui_str': 'Race (observable entity)'}, {'cui': 'C0442533', 'cui_str': 'Mountain (environment)'}]","[{'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0003211', 'cui_str': 'Anti Inflammatory Agents, Nonsteroidal'}, {'cui': 'C0020740', 'cui_str': 'Ibuprofen'}, {'cui': 'C4319574', 'cui_str': 'Capsule'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0242691', 'cui_str': 'Gastrocnemius Muscle'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}, {'cui': 'C0241236', 'cui_str': 'Does squat (finding)'}, {'cui': 'C0560453', 'cui_str': 'Does jump (finding)'}, {'cui': 'C0201973', 'cui_str': 'Creatine kinase measurement (procedure)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0232804', 'cui_str': 'Renal function (observable entity)'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C0600140', 'cui_str': 'Does run (finding)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C2607857'}, {'cui': 'C0205128', 'cui_str': 'Vertical (qualifier value)'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C0022646', 'cui_str': 'Kidney'}, {'cui': 'C0184567', 'cui_str': 'Acute Pain'}, {'cui': 'C1321013', 'cui_str': 'Hydration'}, {'cui': 'C0022917', 'cui_str': 'L-Lactate Dehydrogenase'}, {'cui': 'C0022922', 'cui_str': 'lactate dehydrogenase-K'}, {'cui': 'C0004002', 'cui_str': 'L-Aspartate-2-Oxoglutarate Aminotransferase'}]",20.0,0.0674108,"There were significant time main effects for creatine kinase (CK) (p=0.001; f Cohen=0.25), lactate dehydrogenase (LDH) (p<0.001; f Cohen=2.05), aspartate aminotransferase (AST) (p=0.002; f Cohen=1.53), creatinine (p=0.002; f Cohen=2.24), urea (p=0.001; f Cohen=2.25), heart rate (HR) (p<0.001; f Cohen=4.88) and pain scores (p<0.001; f Cohen=1.93) which all increased during the race.","[{'ForeName': 'Raphael Fabricio', 'Initials': 'RF', 'LastName': 'de Souza', 'Affiliation': 'Department of Physical Education, Federal University of Sergipe-UFS, São Cristovão, Sergipe, Brazil.'}, {'ForeName': 'Dihogo Gama', 'Initials': 'DG', 'LastName': 'de Matos', 'Affiliation': 'Group of Studies and Research of Performance, Sport, Health and Paralympic Sports-GEPEPS, the Federal University of Sergipe-UFS, São Cristovão, Sergipe, Brazil.'}, {'ForeName': 'Alexandre Reis Pires', 'Initials': 'ARP', 'LastName': 'Ferreira', 'Affiliation': 'Department of Physical Education, Federal University of Sergipe-UFS, São Cristovão, Sergipe, Brazil.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Chilibeck', 'Affiliation': 'College of Kinesiology, University of Saskatchewan, Saskatoon, Canada.'}, {'ForeName': 'Natalie de Almeida', 'Initials': 'NA', 'LastName': 'Barros', 'Affiliation': 'Group of Studies and Research of Performance, Sport, Health and Paralympic Sports-GEPEPS, the Federal University of Sergipe-UFS, São Cristovão, Sergipe, Brazil.'}, {'ForeName': 'Alan Santos', 'Initials': 'AS', 'LastName': 'Oliveira', 'Affiliation': 'Department of Physiology and Pharmacology Inflammatory Process, Federal University of Sergipe-UFS, São Cristovão, Sergipe, Brazil.'}, {'ForeName': 'Luana Mendonça', 'Initials': 'LM', 'LastName': 'Cercato', 'Affiliation': 'Department of Physiology and Pharmacology Inflammatory Process, Federal University of Sergipe-UFS, São Cristovão, Sergipe, Brazil.'}, {'ForeName': 'Danielle Soares', 'Initials': 'DS', 'LastName': 'da Silva', 'Affiliation': 'Research center and attention to worker health, Federal University of Sergipe-UFS, São Cristovão, Sergipe, Brazil.'}, {'ForeName': 'Felipe José', 'Initials': 'FJ', 'LastName': 'Aidar', 'Affiliation': 'Department of Physical Education, Federal University of Sergipe-UFS, São Cristovão, Sergipe, Brazil.'}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000002502'] 1286,29489714,Effects of Combined Balance and Plyometric Training on Athletic Performance in Female Basketball Players.,"Bouteraa, I, Negra, Y, Shephard, RJ, and Chelly, MS. Effects of combined balance and plyometric training on athletic performance in female basketball players. J Strength Cond Res 34(7): 1967-1973, 2020-The purpose of this study was to examine the effect of 8 weeks combined balance and plyometric training on the physical fitness of female adolescent basketball players. Twenty-six healthy regional-level players were randomly assigned to either an experimental group (E; n = 16, age = 16.4 ± 0.5) or a control group (C; n = 10, age = 16.5 ± 0.5). C maintained their normal basketball training schedule, whereas for 8 weeks E replaced a part of their standard regimen by biweekly combined training sessions. Testing before and after training included the squat jump (SJ), countermovement jump (CMJ), drop jump (DJ), 5-, 10-, and 20-m sprints, Stork balance test (SBT), Y-balance test (YBT) and modified Illinois change of direction test (MICODT). Results indicated no significant intergroup differences in SJ and CMJ height; however, E increased their DJ height (p < 0.05, Cohens'd = 0.11). No significant intergroup differences were found for sprint performance or SBT, but dynamic YBT tended to a significant group interaction (p = 0.087, d = 0.006). Post hoc analysis also showed a significant increase of MICODT for E (Δ 6.68%, p = 0.041, d = 0.084). In summary, the addition of 8 weeks of balance and plyometric training to regular in-season basketball training proved a safe and feasible intervention that enhanced DJ height, balance, and agility for female adolescent basketball players relative to the standard basketball training regimen.",2020,"No significant inter-group differences were found for sprint performance or SBT, but dynamic YBT tended to a significant group interaction (p = 0.087, d = 0.006).","['female adolescent basketball players', 'Twenty six healthy regional-level players', 'female basketball players']","['combined balance and plyometric training', 'plyometric training to regular in-season basketball training']","['sprint performance or SBT, but dynamic YBT', 'SJ and CMJ height', 'Squat Jump (SJ), Countermovement Jump (CMJ), Drop Jump (DJ), 5, 10 and 20-m sprints, Stork Balance Test (SBT), Y-Balance Test (YBT) and Modified Illinois Change of Direction Test (MICODT', 'DJ height, balance, and agility', 'DJ height', 'athletic performance']","[{'cui': 'C0001588', 'cui_str': 'Adolescents, Female'}, {'cui': 'C0004818', 'cui_str': 'Basketball'}, {'cui': 'C0450349', 'cui_str': '26 (qualifier value)'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0086287', 'cui_str': 'Females'}]","[{'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C3178799', 'cui_str': 'Plyometric Training'}, {'cui': 'C0205272', 'cui_str': 'Regular (qualifier value)'}, {'cui': 'C0036497', 'cui_str': 'Seasons'}, {'cui': 'C0004818', 'cui_str': 'Basketball'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C0241236', 'cui_str': 'Does squat (finding)'}, {'cui': 'C0560453', 'cui_str': 'Does jump (finding)'}, {'cui': 'C4318619', 'cui_str': 'Drop (unit of presentation)'}, {'cui': 'C0325459', 'cui_str': 'Stork'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0439755', 'cui_str': 'Directions (qualifier value)'}, {'cui': 'C0871966', 'cui_str': 'Sports Performance'}]",26.0,0.0116676,"No significant inter-group differences were found for sprint performance or SBT, but dynamic YBT tended to a significant group interaction (p = 0.087, d = 0.006).","[{'ForeName': 'Ichrak', 'Initials': 'I', 'LastName': 'Bouteraa', 'Affiliation': 'Research Unit (UR17JS01), Sport Performance, Health & Society, Higher Institute of Sport and Physical Education of Ksar Saîd, University of ""La Manouba,"" Tunis, Tunisia.'}, {'ForeName': 'Yassine', 'Initials': 'Y', 'LastName': 'Negra', 'Affiliation': 'Research Unit (UR17JS01), Sport Performance, Health & Society, Higher Institute of Sport and Physical Education of Ksar Saîd, University of ""La Manouba,"" Tunis, Tunisia.'}, {'ForeName': 'Roy J', 'Initials': 'RJ', 'LastName': 'Shephard', 'Affiliation': 'Faculty of Kinesiology and Physical Education, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Mohamed Souhaiel', 'Initials': 'MS', 'LastName': 'Chelly', 'Affiliation': 'Research Unit (UR17JS01), Sport Performance, Health & Society, Higher Institute of Sport and Physical Education of Ksar Saîd, University of ""La Manouba,"" Tunis, Tunisia.'}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000002546'] 1287,31039099,Can 7 or 30-Day Recall Questions Capture Self-Reported Lower Urinary Tract Symptoms Accurately?,"PURPOSE Self-reported measurement tools often provide a recall period, eg ""In the past 7 days…"" For lower urinary tract symptoms the concordance of end of day (daily) reports with 7 and 30-day recalled reports is unknown to our knowledge. We evaluated how accurately 7 or 30-day recall questions capture lower urinary tract symptoms. MATERIALS AND METHODS The 261 female and 254 male participants were recruited from a total of 6 United States tertiary care sites. We evaluated 18 items representing 7 symptoms covering storage, voiding and post-micturition symptoms. Item responses on the daily forms were averaged for a 7 or a 30-day period and compared to the corresponding 7 or 30-day recall version of the item. Analyses were item and gender specific. Within person concordance was assessed using the Pearson correlation. Bias (systematic overreporting or underreporting) was calculated as the difference between the recalled item and the averaged daily item score, and reported as a percent of the item scale. RESULTS All correlations exceeded 0.60. Correlations between averaged daily reports and recalled reports ranged from 0.72 to 0.89 for 7 days and from 0.71 to 0.91 for 30 days among women, and from 0.68 to 0.90 and 0.68 to 0.95, respectively, among men. Most items did not show systematic bias and the median percent bias did not exceed 10% for any item. However, bias exceeding ±10% for some items was observed in a subset of individuals. CONCLUSIONS Recalled reports during the 7 and 30 days tracked well with averaged daily reports for men and women. Systematic bias was minimal, suggesting that 7 and 30-day recall periods for self-reported lower urinary tract symptoms are reasonable.",2019,"Correlations between averaged daily reports and recalled reports ranged from 0.72 to 0.89 for 7 days and from 0.71 to 0.91 for 30 days among women, and from 0.68 to 0.90 and 0.68 to 0.95, respectively, among men.",['261 female and 254 male participants were recruited from a total of 6 United States tertiary care sites'],[],[],"[{'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C3494403', 'cui_str': 'Tertiary Care'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}]",[],[],261.0,0.0264053,"Correlations between averaged daily reports and recalled reports ranged from 0.72 to 0.89 for 7 days and from 0.71 to 0.91 for 30 days among women, and from 0.68 to 0.90 and 0.68 to 0.95, respectively, among men.","[{'ForeName': 'Kathryn E', 'Initials': 'KE', 'LastName': 'Flynn', 'Affiliation': 'Medical College of Wisconsin, Milwaukee, Wisconsin.'}, {'ForeName': 'Sarah A', 'Initials': 'SA', 'LastName': 'Mansfield', 'Affiliation': 'Arbor Research Collaborative for Health, Ann Arbor, Michigan.'}, {'ForeName': 'Abigail R', 'Initials': 'AR', 'LastName': 'Smith', 'Affiliation': 'Arbor Research Collaborative for Health, Ann Arbor, Michigan.'}, {'ForeName': 'Brenda W', 'Initials': 'BW', 'LastName': 'Gillespie', 'Affiliation': 'University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Catherine S', 'Initials': 'CS', 'LastName': 'Bradley', 'Affiliation': 'Carver College of Medicine, University of Iowa, Iowa City, Iowa.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Cella', 'Affiliation': 'Northwestern University, Chicago, Illinois.'}, {'ForeName': 'J Quentin', 'Initials': 'JQ', 'LastName': 'Clemens', 'Affiliation': 'University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Margaret E', 'Initials': 'ME', 'LastName': 'Helmuth', 'Affiliation': 'Arbor Research Collaborative for Health, Ann Arbor, Michigan.'}, {'ForeName': 'H Henry', 'Initials': 'HH', 'LastName': 'Lai', 'Affiliation': 'Washington University in St. Louis, St. Louis, Missouri.'}, {'ForeName': 'Ziya', 'Initials': 'Z', 'LastName': 'Kirkali', 'Affiliation': 'National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, Maryland.'}, {'ForeName': 'Pooja', 'Initials': 'P', 'LastName': 'Talaty', 'Affiliation': 'NorthShore University Health System, Glenview, Illinois.'}, {'ForeName': 'Kevin P', 'Initials': 'KP', 'LastName': 'Weinfurt', 'Affiliation': 'Duke University Medical Center, Durham, North Carolina.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Journal of urology,['10.1097/JU.0000000000000310'] 1288,29254398,"Impact of Latin Dance on Physical Activity, Cardiorespiratory Fitness, and Sedentary Behavior Among Latinos Attending an Adult Day Center.","Objective: The aim of this study was to determine whether a Latin dance program with sedentary behavior information would have an impact on physical activity, cardiorespiratory fitness (CRF), and sedentary behavior among older Latinos attending an adult day center (ADC). Method : Participants ( N = 21, 75.4 ± 6.3 years old, Mini-Mental State Examination [MMSE] score = 22.4 ± 2.8) were randomized into a dance or wait-list control group. Participants wore an accelerometer and inclinometer and completed a sedentary behavior questionnaire, and a nonexercise equation was used to calculate CRF. Results : Findings indicate small to medium effect sizes in the desired direction during midpoint of the intervention for physical activity, sedentary behavior-related outcomes, CRF, and self-reported sedentary behavior in the dance group; however; dance participants did not maintain that trajectory for the remaining 2 months of the intervention. Discussion : Future studies may consider implementing behavioral strategies during midpoint of the intervention to encourage participants attending an ADC to maintain physical activity and sedentary behavior changes.",2019,"RESULTS Findings indicate small to medium effect sizes in the desired direction during midpoint of the intervention for physical activity, sedentary behavior-related outcomes, CRF, and self-reported sedentary behavior in the dance group; however; dance participants did not maintain that trajectory for the remaining 2 months of the intervention. ","['older Latinos attending an adult day center (ADC', 'Latinos Attending an Adult Day Center', 'Participants ( N = 21, 75.4 ± 6.3 years old, Mini-Mental State Examination [MMSE] score = 22.4 ± 2.8']",['dance or wait-list control group'],"['physical activity, sedentary behavior-related outcomes, CRF, and self-reported sedentary behavior', 'Physical Activity, Cardiorespiratory Fitness, and Sedentary Behavior', 'physical activity, cardiorespiratory fitness (CRF), and sedentary behavior']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C4319697', 'cui_str': '6.3'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C2960235', 'cui_str': 'Mini-mental state examination score (observable entity)'}]","[{'cui': 'C0010963', 'cui_str': 'Dancing'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1532253', 'cui_str': 'Sedentary Behavior'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0010132', 'cui_str': 'corticorelin'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}]",,0.0297971,"RESULTS Findings indicate small to medium effect sizes in the desired direction during midpoint of the intervention for physical activity, sedentary behavior-related outcomes, CRF, and self-reported sedentary behavior in the dance group; however; dance participants did not maintain that trajectory for the remaining 2 months of the intervention. ","[{'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Aguiñaga', 'Affiliation': 'University of Illinois at Urbana-Champaign, USA.'}, {'ForeName': 'David X', 'Initials': 'DX', 'LastName': 'Marquez', 'Affiliation': 'University of Illinois at Chicago, USA.'}]",Journal of aging and health,['10.1177/0898264317733206'] 1289,31860383,Safety and immunogenicity of VGX-3100 formulations in a healthy young adult population.,"HPV remains the most common sexually transmitted disease worldwide, despite improvements in awareness, screening, prophylactic vaccination uptake, and surgical treatment. VGX-3100 is an immunotherapy that uses electroporation to introduce DNA encoding for modified HPV-16 and HPV-18, E6-and E7 proteins into myocytes to stimulate an effector T cell response. We now report immunogenicity and safety of VGX-3100 for a refrigeration-stable formulation, which improves patient-care setting usability. This multi-arm, double-blinded, randomized trial enrolled 235 healthy men and women to receive either a refrigerated (RF) or frozen formulation (FF) of VGX-3100. Three doses were administered intramuscularly with electroporation at 0, 4, and 12 weeks. Non-inferiority of RF to FF was assessed by comparing the proportion of subjects who achieved a ≥2-fold increase from baseline to Week 14 in Spot Forming Units/10 6 PMBCs using an interferon-γ enzyme-linked immunospot assay. There were no related SAEs. Injection site reactions were the most common adverse event (54%, RF; 66%, FF) the majority of which resolved within a few minutes following administration. The primary endpoint was met with 89.9% of RF recipients and 97.2% of FF recipients reaching a ≥2-fold rise in SFU/10 6 PBMC, 2 weeks following the last dose; RF was statistically non-inferior to FF ( p = .022). A systemic, immunologic approach has the potential to fill a critical gap in the ability to treat men and women with high grade HPV diseases. These safety and immunogenicity data are supportive of the continued development of a refrigerated formulation of VGX-3100.",2020,"Injection site reactions were the most common adverse event (54%, RF; 66%, FF) the majority of which resolved within a few minutes following administration.","['235 healthy men and women to receive either a', 'men and women with high grade HPV diseases', 'healthy young adult population']","['VGX-3100 formulations', 'VGX-3100', 'refrigerated (RF) or frozen formulation (FF) of VGX-3100']","['Safety and immunogenicity', 'inferiority of RF to FF']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1962917', 'cui_str': 'High grade (lymphoma)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C2703096', 'cui_str': 'VGX-3100'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}]",235.0,0.191103,"Injection site reactions were the most common adverse event (54%, RF; 66%, FF) the majority of which resolved within a few minutes following administration.","[{'ForeName': 'Rebecca K', 'Initials': 'RK', 'LastName': 'Hollenberg', 'Affiliation': 'Inovio Pharmaceuticals, Inc ., Plymouth Meeting, PA, USA.'}, {'ForeName': 'Diane R', 'Initials': 'DR', 'LastName': 'Krieger', 'Affiliation': 'Miami Research Associates , Miami, FL, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Samuels', 'Affiliation': 'Inovio Pharmaceuticals, Inc ., Plymouth Meeting, PA, USA.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Kraynyak', 'Affiliation': 'Inovio Pharmaceuticals, Inc ., Plymouth Meeting, PA, USA.'}, {'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Sylvester', 'Affiliation': 'Inovio Pharmaceuticals, Inc ., Plymouth Meeting, PA, USA.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Morrow', 'Affiliation': 'Inovio Pharmaceuticals, Inc ., Plymouth Meeting, PA, USA.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Boyer', 'Affiliation': 'Inovio Pharmaceuticals, Inc ., Plymouth Meeting, PA, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Dallas', 'Affiliation': 'Inovio Pharmaceuticals, Inc ., Plymouth Meeting, PA, USA.'}, {'ForeName': 'Prakash K', 'Initials': 'PK', 'LastName': 'Bhuyan', 'Affiliation': 'Inovio Pharmaceuticals, Inc ., Plymouth Meeting, PA, USA.'}]",Human vaccines & immunotherapeutics,['10.1080/21645515.2019.1695459'] 1290,31585725,"Immunogenicity, safety and reactogenicity of a Phase II trial of Vi-DT typhoid conjugate vaccine in healthy Filipino infants and toddlers: A preliminary report.","BACKGROUND Typhoid fever remains an important public health problem in developing countries and is endemic in many parts of Asia and Africa where the incidence of disease typically peaks in school-aged children. Age restrictions and other limitations of existing oral live-attenuated typhoid and parenteral Vi polysaccharide vaccines have triggered the development of Vi conjugate vaccines with improved immunological properties, use in younger age range, and longer durability of protection. We present the safety, reactogenicity, and immunogenicity data from a Phase II study after a single dose of Vi polysaccharide conjugated to diphtheria toxoid (Vi-DT) conducted in 6-23-month old Filipino children. METHODS This is a randomized, observer-blinded Phase II study to assess the immunogenicity, safety and reactogenicity of Vi-DT compared to placebo, conducted in Muntinlupa City, The Philippines. Participants aged 6-23 months were enrolled and randomized to Vi-DT (25 µg) or placebo (0.9% sodium chloride) and evaluated for immunogenicity and overall safety 28 days post vaccination. RESULTS A total of 285 participants were enrolled and age-stratified: 6 to < 9 months, 9-12 months, and 13-23 months. Seventy-six (76) participants received Vi-DT and 19 received placebo per each strata. All participants seroconverted after a single dose of Vi-DT versus 7% of placebo recipients. Anti-Vi IgG GMT was 444.38 [95% CI (400.28; 493.34)] after a single dose of Vi-DT; there was no change in GMT after placebo administration, 0.41 [95% CI (0.33; 0.51), p < 0.0001]. A similar pattern of immunogenicity was reported across all age strata. The vaccine reported to be safe and well tolerated. CONCLUSIONS Vi-DT vaccine was immunogenic, safe, and well tolerated in children aged 6-23 months. ClinicalTrials.gov registration number: NCT03527355.",2020,"BACKGROUND Typhoid fever remains an important public health problem in developing countries and is endemic in many parts of Asia and Africa where the incidence of disease typically peaks in school-aged children.","['Muntinlupa City, The Philippines', 'healthy Filipino infants and toddlers', 'school-aged children', 'Participants aged 6-23\u202fmonths', '6-23-month old Filipino children', '285 participants were enrolled and age-stratified: 6 to < 9\u202fmonths, 9-12\u202fmonths, and 13-23\u202fmonths', 'Seventy-six (76) participants received', 'children aged 6-23\u202fmonths']","['Vi-DT vaccine', 'Vi-DT', 'placebo (0.9% sodium chloride', 'placebo', 'Vi-DT typhoid conjugate vaccine', 'Vi polysaccharide conjugated to diphtheria toxoid (Vi-DT']","['safety, reactogenicity, and immunogenicity data', 'GMT', 'Immunogenicity, safety and reactogenicity', 'safe and well tolerated', 'immunogenicity, safety and reactogenicity']","[{'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C1556093', 'cui_str': 'Filipinos (ethnic group)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0682053', 'cui_str': 'Toddler (qualifier value)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C4319622', 'cui_str': 'Seventy-six'}]","[{'cui': 'C0058773', 'cui_str': 'DT Vaccine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4068881', 'cui_str': 'Zero point nine'}, {'cui': 'C0037494', 'cui_str': 'Sodium Chloride'}, {'cui': 'C0041466', 'cui_str': 'Salmonella typhi Infection'}, {'cui': 'C0206515', 'cui_str': 'Vaccines, Conjugate'}, {'cui': 'C0032594', 'cui_str': 'Glycans'}, {'cui': 'C0301869', 'cui_str': 'Conjugate'}, {'cui': 'C0012551', 'cui_str': 'diphtheria toxoid vaccine, inactivated'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}]",285.0,0.64885,"BACKGROUND Typhoid fever remains an important public health problem in developing countries and is endemic in many parts of Asia and Africa where the incidence of disease typically peaks in school-aged children.","[{'ForeName': 'Maria Rosario', 'Initials': 'MR', 'LastName': 'Capeding', 'Affiliation': 'Research Institute for Tropical Medicine, Manila, Philippines.'}, {'ForeName': 'Edison', 'Initials': 'E', 'LastName': 'Alberto', 'Affiliation': 'Research Institute for Tropical Medicine, Manila, Philippines.'}, {'ForeName': 'Arijit', 'Initials': 'A', 'LastName': 'Sil', 'Affiliation': 'International Vaccine Institute, Seoul, Republic of Korea.'}, {'ForeName': 'Tarun', 'Initials': 'T', 'LastName': 'Saluja', 'Affiliation': 'International Vaccine Institute, Seoul, Republic of Korea. Electronic address: tarun.saluja@ivi.int.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Teshome', 'Affiliation': 'International Vaccine Institute, Seoul, Republic of Korea.'}, {'ForeName': 'Deok Ryun', 'Initials': 'DR', 'LastName': 'Kim', 'Affiliation': 'International Vaccine Institute, Seoul, Republic of Korea.'}, {'ForeName': 'Ju Yeon', 'Initials': 'JY', 'LastName': 'Park', 'Affiliation': 'International Vaccine Institute, Seoul, Republic of Korea.'}, {'ForeName': 'Jae Seung', 'Initials': 'JS', 'LastName': 'Yang', 'Affiliation': 'International Vaccine Institute, Seoul, Republic of Korea.'}, {'ForeName': 'Suchada', 'Initials': 'S', 'LastName': 'Chinaworapong', 'Affiliation': 'International Vaccine Institute, Seoul, Republic of Korea.'}, {'ForeName': 'Jiwook', 'Initials': 'J', 'LastName': 'Park', 'Affiliation': 'International Vaccine Institute, Seoul, Republic of Korea.'}, {'ForeName': 'Sue-Kyoung', 'Initials': 'SK', 'LastName': 'Jo', 'Affiliation': 'International Vaccine Institute, Seoul, Republic of Korea.'}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Chon', 'Affiliation': 'International Vaccine Institute, Seoul, Republic of Korea.'}, {'ForeName': 'Seon-Young', 'Initials': 'SY', 'LastName': 'Yang', 'Affiliation': 'SK Bioscience, Seoul, Republic of Korea.'}, {'ForeName': 'Dong Soo', 'Initials': 'DS', 'LastName': 'Ham', 'Affiliation': 'SK Bioscience, Seoul, Republic of Korea.'}, {'ForeName': 'Ji Hwa', 'Initials': 'JH', 'LastName': 'Ryu', 'Affiliation': 'SK Bioscience, Seoul, Republic of Korea.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Lynch', 'Affiliation': 'International Vaccine Institute, Seoul, Republic of Korea.'}, {'ForeName': 'Jerome H', 'Initials': 'JH', 'LastName': 'Kim', 'Affiliation': 'International Vaccine Institute, Seoul, Republic of Korea.'}, {'ForeName': 'Hun', 'Initials': 'H', 'LastName': 'Kim', 'Affiliation': 'SK Bioscience, Seoul, Republic of Korea.'}, {'ForeName': 'Jean-Louis', 'Initials': 'JL', 'LastName': 'Excler', 'Affiliation': 'International Vaccine Institute, Seoul, Republic of Korea.'}, {'ForeName': 'T Anh', 'Initials': 'TA', 'LastName': 'Wartel', 'Affiliation': 'International Vaccine Institute, Seoul, Republic of Korea.'}, {'ForeName': 'Sushant', 'Initials': 'S', 'LastName': 'Sahastrabuddhe', 'Affiliation': 'International Vaccine Institute, Seoul, Republic of Korea.'}]",Vaccine,['10.1016/j.vaccine.2019.09.074'] 1291,29385007,Alcohol After Resistance Exercise Does Not Affect Muscle Power Recovery.,"Levitt, DE, Idemudia, NO, Cregar, CM, Duplanty, AA, Hill, DW, and Vingren, JL. Alcohol after resistance exercise does not affect muscle power recovery. J Strength Cond Res 34(7): 1938-1944, 2020-The purpose of this study was to investigate the effect of alcohol consumed after heavy eccentric resistance exercise on measures of muscle power. After familiarization and an initial eccentric exercise bout to control for the ""repeated-bout effect,"" 10 recreationally resistance-trained men completed 2 identical heavy eccentric squat bouts (4 sets of 10 repetitions at 110% of concentric 1-repetition maximum) 1 week apart. Each exercise bout was followed by ingestion of a beverage containing either alcohol (1.09 g ethanol·kg fat-free body mass) or no alcohol (placebo; volume of alcohol replaced with water). Vertical jump (VJ) peak power, VJ peak force, VJ jump height, change-of-direction ability (shuttle run), sprint acceleration (sprint test), and muscle soreness were measured before (PRE), 24 hours after (24H), and 48 hours after (48H) each eccentric exercise bout. Although the exercise bout resulted in significantly (p ≤ 0.05) decreased VJ peak power at 24H, significantly decreased VJ jump height at 24H, and significantly increased muscle soreness at 24H and 48H, consuming alcohol after the exercise bout did not affect any of the performance outcome measures. When consumed after a non-novel heavy eccentric resistance exercise bout, alcohol did not affect soreness or recovery of muscular power. Practitioners can use this information to advise their athletes with regard to responsible alcohol use after non-novel exercise. Although short-term anaerobic performance does not seem compromised as a result of acute postexercise alcohol ingestion, practitioners and athletes should be aware of potential long-term effects of such alcohol use.",2020,"Although the exercise bout resulted in significantly (p < 0.05) decreased VJ peak power at 24H, significantly decreased VJ jump height at 24H, and significantly increased muscle soreness at 24H and 48H, consuming alcohol after the exercise bout did not affect any of the performance outcome measures.",[],"['exercise bout was followed by ingestion of a beverage containing either alcohol (1.09 g ethanol[BULLET OPERATOR]kg fat-free body mass) or no alcohol (placebo; volume of alcohol replaced with water', 'initial eccentric exercise bout to control for the ""repeated-bout effect,"" ten recreationally resistance-trained men completed two identical heavy eccentric squat bouts', 'alcohol consumed after heavy eccentric resistance exercise', 'Alcohol after Resistance Exercise']","['VJ peak power', 'VJ jump height', 'Vertical jump (VJ) peak power, VJ peak force, VJ jump height, change-of-direction ability (shuttle run), sprint acceleration (sprint test), and muscle soreness', 'measures of muscle power', 'soreness or recovery of muscular power', 'muscle soreness']",[],"[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0005329', 'cui_str': 'Beverages'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C4517490', 'cui_str': '1.09 (qualifier value)'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0439740', 'cui_str': 'Eccentric (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0205280', 'cui_str': 'Identical (qualifier value)'}, {'cui': 'C0439539', 'cui_str': 'Heavy sensation quality'}, {'cui': 'C0241236', 'cui_str': 'Does squat (finding)'}]","[{'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0560453', 'cui_str': 'Does jump (finding)'}, {'cui': 'C0205128', 'cui_str': 'Vertical (qualifier value)'}, {'cui': 'C0443221', 'cui_str': 'Forced (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0439755', 'cui_str': 'Directions (qualifier value)'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0600140', 'cui_str': 'Does run (finding)'}, {'cui': 'C0000894', 'cui_str': 'Acceleration'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0231528', 'cui_str': 'Muscle Pain'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0427052', 'cui_str': 'Finding of power of skeletal muscle'}, {'cui': 'C0234233', 'cui_str': 'Tenderness (finding)'}, {'cui': 'C0442025', 'cui_str': 'Muscular (qualifier value)'}]",,0.030715,"Although the exercise bout resulted in significantly (p < 0.05) decreased VJ peak power at 24H, significantly decreased VJ jump height at 24H, and significantly increased muscle soreness at 24H and 48H, consuming alcohol after the exercise bout did not affect any of the performance outcome measures.","[{'ForeName': 'Danielle E', 'Initials': 'DE', 'LastName': 'Levitt', 'Affiliation': 'Applied Physiology Laboratory, Department of Kinesiology, Health Promotion, and Recreation, University of North Texas, Denton, Texas.'}, {'ForeName': 'Nosakhare O', 'Initials': 'NO', 'LastName': 'Idemudia', 'Affiliation': 'Applied Physiology Laboratory, Department of Kinesiology, Health Promotion, and Recreation, University of North Texas, Denton, Texas.'}, {'ForeName': 'Carianne M', 'Initials': 'CM', 'LastName': 'Cregar', 'Affiliation': 'Applied Physiology Laboratory, Department of Kinesiology, Health Promotion, and Recreation, University of North Texas, Denton, Texas.'}, {'ForeName': 'Anthony A', 'Initials': 'AA', 'LastName': 'Duplanty', 'Affiliation': ""Department of Kinesiology, Texas Woman's University, Denton, Texas.""}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Hill', 'Affiliation': 'Applied Physiology Laboratory, Department of Kinesiology, Health Promotion, and Recreation, University of North Texas, Denton, Texas.'}, {'ForeName': 'Jakob L', 'Initials': 'JL', 'LastName': 'Vingren', 'Affiliation': 'Applied Physiology Laboratory, Department of Kinesiology, Health Promotion, and Recreation, University of North Texas, Denton, Texas.'}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000002455'] 1292,31621523,"Improving HbA 1c with Glucose Self-Monitoring in Diabetic Patients with EpxDiabetes, a Phone Call and Text Message-Based Telemedicine Platform: A Randomized Controlled Trial.","Background: We conducted a randomized controlled trial of EpxDiabetes, a novel digital health intervention as an adjunct therapy to reduce HbA 1c and fasting blood glucose (FBG) among patients with type 2 diabetes mellitus (T2DM). In addition, we examined the effect of social determinants of health on our system. Methods: Sixty-five ( n  = 65) patients were randomized at a primary care clinic. Self-reported FBG data were collected by EpxDiabetes automated phone calls or text messages. Only intervention group responses were shared with providers, facilitating follow-up and bidirectional communication. ΔHbA 1c and ΔFBG were analyzed after 6 months. Results: There was an absolute HbA 1c reduction of 0.69% in the intervention group (95% confidence interval [CI], -1.41 to 0.02) and an absolute reduction of 0.03% in the control group (95% CI, -0.88 to 0.82). For those with baseline HbA 1c >8%, HbA 1c decreased significantly by 1.17% in the intervention group (95% CI, -1.90 to -0.44), and decreased by 0.02% in the control group (95% CI, -0.99 to 0.94). FBG decreased in the intervention group by 21.6 mg/dL (95% CI, -37.56 to -5.639), and increased 13.0 mg/dL in the control group (95% CI, -47.67 to 73.69). Engagement (proportion responding to ≥25% of texts or calls over 4 weeks) was 58% for the intervention group (95% CI, 0.373-0.627) and 48% for the control group (95% CI, 0.296-0.621). Smoking, number of comorbidities, and response rate were significant predictors of ΔHbA 1c . Conclusions: EpxDiabetes helps to reduce HbA 1c in patients with uncontrolled T2DM and fosters patient-provider communication; it has definite merit as an adjunct therapy in diabetes management. Future work will focus on improving the acceptability of the system and implementation on a larger scale trial.",2020,"FBG decreased in the intervention group by 21.6 mg/dL (95% CI, -37.56 to -5.639), and increased 13.0 mg/dL in the control group (95% CI, -47.67 to 73.69).","['Diabetic Patients with EpxDiabetes', 'Methods: Sixty-five ( n \u2009=\u200965', 'patients with type 2 diabetes mellitus (T2DM']",['novel digital health intervention'],"['FBG', 'HbA 1c and fasting blood glucose (FBG', 'HbA 1c', 'Smoking, number of comorbidities, and response rate', 'ΔHbA 1c and ΔFBG']","[{'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0450385', 'cui_str': '65 (qualifier value)'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}]","[{'cui': 'C0442015', 'cui_str': 'Digital X-ray (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}]","[{'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}]",,0.0600336,"FBG decreased in the intervention group by 21.6 mg/dL (95% CI, -37.56 to -5.639), and increased 13.0 mg/dL in the control group (95% CI, -47.67 to 73.69).","[{'ForeName': 'Ran', 'Initials': 'R', 'LastName': 'Xu', 'Affiliation': 'Washington University School of Medicine in St. Louis, St. Louis, Missouri, USA.'}, {'ForeName': 'Maggie', 'Initials': 'M', 'LastName': 'Xing', 'Affiliation': 'Washington University School of Medicine in St. Louis, St. Louis, Missouri, USA.'}, {'ForeName': 'Kavon', 'Initials': 'K', 'LastName': 'Javaherian', 'Affiliation': 'Washington University School of Medicine in St. Louis, St. Louis, Missouri, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Peters', 'Affiliation': 'Washington University School of Medicine in St. Louis, St. Louis, Missouri, USA.'}, {'ForeName': 'Will', 'Initials': 'W', 'LastName': 'Ross', 'Affiliation': 'Washington University School of Medicine in St. Louis, St. Louis, Missouri, USA.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Bernal-Mizrachi', 'Affiliation': 'Division of Endocrinology, Metabolism and Lipid Research, Washington University School of Medicine, St. Louis, Missouri, USA.'}]",Telemedicine journal and e-health : the official journal of the American Telemedicine Association,['10.1089/tmj.2019.0035'] 1293,31886700,Attentional and approach biases to alcohol cues among young adult drinkers: An ecological momentary assessment study.,"Alcohol-specific attentional biases (AttB) and approach biases (AppB) are postulated to play a role in alcohol use disorders but their association with drinking in young adults remains unknown. A subsample of young adults with risky alcohol use ( N = 296) enrolled in a randomized trial, testing different text message interventions completed weekly tasks via a mobile app for up to 14 weeks: Alcohol Stroop was used to measure AttB and Approach-Avoidance Task was used to measure AppB. Participants also provided reports of their alcohol consumption up to twice per week. We analyzed feasibility of measuring alcohol biases on mobile phones, whether repeated testing and conditions of testing affected mean reaction times (RTs), and whether mean AttB and AppB scores were associated with baseline alcohol use severity and same-day binge drinking (4+/5+ drinks per occasion for women/men). Task completion decreased from 93% on Week 1% to 39% by Week 14 with a mean of 8.2 weeks completed. Mean RTs for Alcohol Stroop decreased over weeks assessed. RTs to Stroop and Approach-Avoid tasks were longer when participants reported distractions or after alcohol and/or drug use. Mean AttB and AppB scores were not associated with baseline drinking, and within-day fluctuations of AttB and AppB scores did not predict same day binge drinking. Barriers to measuring alcohol biases in the natural environment include learning effects, contextual influences of distractions and prior alcohol/drug use, and absence of robust associations of RTs to alcohol cues with either baseline or same-day alcohol consumption. (PsycINFO Database Record (c) 2019 APA, all rights reserved).",2019,RTs to Stroop and Approach-Avoid tasks were longer when participants reported distractions or after alcohol and/or drug use.,"['young adult drinkers', 'A subsample of young adults with risky alcohol use ( N = 296']","['Alcohol-specific attentional biases (AttB) and approach biases (AppB', 'text message interventions completed weekly tasks via a mobile app for up to 14 weeks']","['mean reaction times (RTs), and whether mean AttB and AppB scores', 'Task completion', 'Mean RTs for Alcohol Stroop', 'Mean AttB and AppB scores']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}]","[{'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C4277667', 'cui_str': 'Attentional Bias'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0005346', 'cui_str': 'Bias'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}]",2019.0,0.01433,RTs to Stroop and Approach-Avoid tasks were longer when participants reported distractions or after alcohol and/or drug use.,"[{'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Suffoletto', 'Affiliation': 'Department of Emergency Medicine.'}, {'ForeName': 'Matt', 'Initials': 'M', 'LastName': 'Field', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Tammy', 'Initials': 'T', 'LastName': 'Chung', 'Affiliation': 'Department of Psychiatry.'}]",Experimental and clinical psychopharmacology,['10.1037/pha0000343'] 1294,29338313,Rapport Building and Instructional Fading Prior to Discrete Trial Instruction: Moving From Child-Led Play to Intensive Teaching.,"Discrete trial instruction (DTI) is effective for teaching skills to children with autism spectrum disorder (ASD). Although effective, instructional settings can become aversive resulting in avoidant and escape-related behaviors. Given the significant social impairments associated with ASD, interventions that promote social approach and reduce avoidance are warranted. Rapport building or ""pairing"" the therapist and teaching setting with highly preferred activities prior to instruction can reduce problematic behaviors during subsequent instruction. However, the path from child-led play to DTI is not well established. Instructional fading may assist in bridging this gap. Four participants with ASD who were beginning an intensive behavioral intervention program were included in the current study. Participants progressed through nine stages of pairing and instructional fading with minimal problem behavior and high percentages of in-seat and close proximity to the therapist. Guidelines for incorporating rapport building strategies prior to intensive teaching with children with ASD are proposed.",2019,"Rapport building or ""pairing"" the therapist and teaching setting with highly preferred activities prior to instruction can reduce problematic behaviors during subsequent instruction.","['children with autism spectrum disorder (ASD', 'children with ASD', 'Four participants with ASD who were beginning an intensive behavioral intervention program were included in the current study']","['Rapport Building and Instructional Fading Prior to Discrete Trial Instruction', 'Discrete trial instruction (DTI']",[],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1510586', 'cui_str': 'Autism Spectrum Disorders'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0039401', 'cui_str': 'Teaching'}]",[],4.0,0.0212809,"Rapport building or ""pairing"" the therapist and teaching setting with highly preferred activities prior to instruction can reduce problematic behaviors during subsequent instruction.","[{'ForeName': 'M Alice', 'Initials': 'MA', 'LastName': 'Shillingsburg', 'Affiliation': 'Emory University School of Medicine, Atlanta, GA, USA.'}, {'ForeName': 'Bethany', 'Initials': 'B', 'LastName': 'Hansen', 'Affiliation': 'Emory University School of Medicine, Atlanta, GA, USA.'}, {'ForeName': 'Melinda', 'Initials': 'M', 'LastName': 'Wright', 'Affiliation': 'Marcus Autism Center, Atlanta, GA, USA.'}]",Behavior modification,['10.1177/0145445517751436'] 1295,29331848,"Repetitive transcranial magnetic stimulation for apathy in mild cognitive impairment: A double-blind, randomized, sham-controlled, cross-over pilot study.","Apathy is a common and disabling behavioral concomitant of many neurodegenerative conditions. The presence of apathy with Mild Cognitive Impairment (MCI) is linked with heightened rates of conversion to Alzheimer's disease. Improving apathy may slow the neurodegenerative process. The objective was to establish the efficacy of repetitive transcranial magnetic stimulation (rTMS) in improving apathy in older adults with MCI. An 8-week, double-blind, randomized, sham-controlled cross-over study was conducted in nine subjects (66 ± 9 years) with apathy and MCI. Subjects were randomized to rTMS or sham treatment (5 days/week) for 2 weeks following which they underwent a 4-week treatment-free period. Subjects then crossed-over to receive the other treatment for 2 weeks. The primary (apathy (AES-C)) and secondary (cognition (3MS & MMSE), executive function (TMT-A & TMT-B), and clinical global impression (CGI)) outcomes were assessed at baseline, 2, 6, and 8 weeks. After adjusting for baseline, there was a significantly greater improvement in the AES-C with rTMS compared to sham treatment at 2 weeks. There was significantly greater improvement in 3MS, MMSE, TMT-A, and CGI-I with rTMS compared to the sham treatment. This study establishes that rTMS is efficacious in improving apathy in subjects with MCI.",2018,"There was significantly greater improvement in 3MS, MMSE, TMT-A, and CGI","['older adults with MCI', 'subjects with MCI', 'mild cognitive impairment', 'nine subjects (66 ± 9 years) with apathy and MCI']","['Repetitive transcranial magnetic stimulation', 'rTMS', 'repetitive transcranial magnetic stimulation (rTMS']","['3MS, MMSE, TMT-A, and CGI', 'primary (apathy (AES-C)) and secondary (cognition (3MS & MMSE), executive function (TMT-A & TMT-B), and clinical global impression (CGI)) outcomes']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0560005', 'cui_str': 'millicurie'}, {'cui': 'C1270972', 'cui_str': 'Mild Neurocognitive Disorder'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0085632', 'cui_str': 'Apathy'}]","[{'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}]","[{'cui': 'C0451306', 'cui_str': 'Folstein Mini-Mental State Examination'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0085632', 'cui_str': 'Apathy'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}]",,0.25973,"There was significantly greater improvement in 3MS, MMSE, TMT-A, and CGI","[{'ForeName': 'Prasad R', 'Initials': 'PR', 'LastName': 'Padala', 'Affiliation': 'Geriatric Research Education and Clinical Center, Central Arkansas Veterans Healthcare System, Little Rock, AR, USA; Department of Psychiatry, University of Arkansas for Medical Sciences, Little Rock, AR, USA; Department of Geriatrics, University of Arkansas for Medical Sciences, Little Rock, AR, USA. Electronic address: Prasad.Padala@va.gov.'}, {'ForeName': 'Kalpana P', 'Initials': 'KP', 'LastName': 'Padala', 'Affiliation': 'Geriatric Research Education and Clinical Center, Central Arkansas Veterans Healthcare System, Little Rock, AR, USA; Department of Geriatrics, University of Arkansas for Medical Sciences, Little Rock, AR, USA.'}, {'ForeName': 'Shelly Y', 'Initials': 'SY', 'LastName': 'Lensing', 'Affiliation': 'Geriatric Research Education and Clinical Center, Central Arkansas Veterans Healthcare System, Little Rock, AR, USA; Department of Biostatistics, University of Arkansas for Medical Sciences, Little Rock, AR, USA.'}, {'ForeName': 'Andrea N', 'Initials': 'AN', 'LastName': 'Jackson', 'Affiliation': 'Geriatric Research Education and Clinical Center, Central Arkansas Veterans Healthcare System, Little Rock, AR, USA.'}, {'ForeName': 'Cassandra R', 'Initials': 'CR', 'LastName': 'Hunter', 'Affiliation': 'Geriatric Research Education and Clinical Center, Central Arkansas Veterans Healthcare System, Little Rock, AR, USA.'}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': 'Parkes', 'Affiliation': 'Geriatric Research Education and Clinical Center, Central Arkansas Veterans Healthcare System, Little Rock, AR, USA.'}, {'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Dennis', 'Affiliation': 'Geriatric Research Education and Clinical Center, Central Arkansas Veterans Healthcare System, Little Rock, AR, USA; Department of Geriatrics, University of Arkansas for Medical Sciences, Little Rock, AR, USA.'}, {'ForeName': 'Melinda M', 'Initials': 'MM', 'LastName': 'Bopp', 'Affiliation': 'Geriatric Research Education and Clinical Center, Central Arkansas Veterans Healthcare System, Little Rock, AR, USA.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Caceda', 'Affiliation': 'Department of Psychiatry, Stony Brook University Medical Center, Stony Brook, NY, USA.'}, {'ForeName': 'Mark S', 'Initials': 'MS', 'LastName': 'Mennemeier', 'Affiliation': 'Neurobiology and Developmental Sciences, University of Arkansas for Medical Sciences, Little Rock, AR, USA.'}, {'ForeName': 'Paula K', 'Initials': 'PK', 'LastName': 'Roberson', 'Affiliation': 'Geriatric Research Education and Clinical Center, Central Arkansas Veterans Healthcare System, Little Rock, AR, USA; Department of Biostatistics, University of Arkansas for Medical Sciences, Little Rock, AR, USA.'}, {'ForeName': 'Dennis H', 'Initials': 'DH', 'LastName': 'Sullivan', 'Affiliation': 'Geriatric Research Education and Clinical Center, Central Arkansas Veterans Healthcare System, Little Rock, AR, USA; Department of Geriatrics, University of Arkansas for Medical Sciences, Little Rock, AR, USA.'}]",Psychiatry research,['10.1016/j.psychres.2017.12.063'] 1296,31031045,Assessment of the effectiveness and safety of two radiofrequency techniques for the treatment of knee pain secondary to gonarthrosis. Prospective randomized double blind study.,"BACKGROUND AND OBJECTIVE In patients with knee pain due to gonarthrosis, we have treatments that are not free of side effects. OBJECTIVE to evaluate the analgesic efficacy of radiofrequency (pulsed and conventional) on the saphenous nerve at the subsartorial level and the genicular nerves of the knee, by ultrasonography. MATERIALS AND METHODS Prospective, randomized, double-blind clinical trial. G1 (RDF1): subjects subjected to radiofrequency, G2 (PLCB): subjects subjected to placebo. A decrease ≥30% of the pain was considered clinically relevant, according to numerical rating scale and in the Western Ontario and McMaster Universities Osteoarthritis Index, global patient impression questionnaire (PGIC) and health status questionnaire (SF-12) in the evaluation at month, three months and six months after the completion of the technique. RESULTS 28 patients (G1: 12, G2: 16), 72% women, age: 75.2±9.1 years, body mass index: 29.9±4.64. The analysis did not show a pain reduction, neither statistically significant, not clinically relevant, at one month, three, or six months with respect to the start of treatment, in the Western Ontario and McMaster Universities Osteoarthritis Index questionnaire and numerical rating scale (rest, movement). Regarding PGIC and the SF-12 questionnaire, there were no statistically significant differences between G1 and G2 either before or after treatment. CONCLUSIONS The combination of two radiofrequency techniques, does not cause a reduction in the intensity of the knee pain, at month, three, or at six months after its completion. It is necessary to change the radiofrequency technique and include more variables to continue with the efficacy study.",2019,"Regarding PGIC and the SF-12 questionnaire, there were no statistically significant differences between G1 and G2 either before or after treatment. ","['patients with knee pain due to gonarthrosis', 'knee pain secondary to gonarthrosis', '28 patients (G1: 12, G2: 16), 72% women, age: 75.2±9.1 years, body mass index: 29.9±4.64']","['placebo', 'G1', 'radiofrequency, G2 (PLCB', 'radiofrequency techniques', 'radiofrequency (pulsed and conventional']","['pain reduction', 'analgesic efficacy', 'numerical rating scale and in the Western Ontario and McMaster Universities Osteoarthritis Index, global patient impression questionnaire (PGIC) and health status questionnaire (SF-12', 'Western Ontario and McMaster Universities Osteoarthritis Index questionnaire and numerical rating scale (rest, movement']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0231749', 'cui_str': 'Knee pain (finding)'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis, Knee'}, {'cui': 'C0175668', 'cui_str': 'Secondary (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0034107', 'cui_str': 'Pulse'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0222045'}, {'cui': 'C3472647', 'cui_str': 'WOMAC index'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0018759', 'cui_str': 'Level of Health'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0026649', 'cui_str': 'Movement'}]",72.0,0.0878287,"Regarding PGIC and the SF-12 questionnaire, there were no statistically significant differences between G1 and G2 either before or after treatment. ","[{'ForeName': 'M M', 'Initials': 'MM', 'LastName': 'Monerris Tabasco', 'Affiliation': 'Servicio de Anestesiología, Reanimación y Terapéutica del Dolor, Hospital Universitario Germans Trias i Pujol, Badalona, Barcelona, España. Electronic address: mmmonerris.germanstrias@gencat.cat.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Roca Amatria', 'Affiliation': 'Servicio de Anestesiología, Reanimación y Terapéutica del Dolor, Hospital Universitario Germans Trias i Pujol, Badalona, Barcelona, España.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Ríos Márquez', 'Affiliation': 'Servicio de Anestesiología, Reanimación y Terapéutica del Dolor, Hospital Universitario Germans Trias i Pujol, Badalona, Barcelona, España.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Jiménez Capel', 'Affiliation': 'Servicio de Anestesiología, Reanimación y Terapéutica del Dolor, Hospital Universitario Germans Trias i Pujol, Badalona, Barcelona, España.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Samper Bernal', 'Affiliation': 'Servicio de Anestesiología, Reanimación y Terapéutica del Dolor, Hospital Universitario Germans Trias i Pujol, Badalona, Barcelona, España.'}]",Revista espanola de anestesiologia y reanimacion,['10.1016/j.redar.2019.03.011'] 1297,31619131,The utility of cognitive changes in identifying those with acute graft vs. host disease following allogeneic hematopoietic cell transplant.,"Objectives: Acute graft versus host disease (aGVHD) is a common complication of allogeneic hematopoietic cell transplant (HCT) and is associated with morbidity and mortality. Identifying those at risk for developing aGVHD is crucial for early intervention. The current study assessed whether scores on a brief cognitive screening measure could identify those that develop aGVHD by 100 days post-HCT. Methods: Participants were 37 patients undergoing allogeneic HCT, assessed prior to transplant, and at 30- and 100-days post-HCT. Of those completing all evaluations, patients were divided into those who did ( n  = 14) and did not ( n  = 16) develop aGVHD by day 100 post-HCT. At 100 days post-transplant, groups did not differ on relevant demographic factors, disease, conditioning regimen, relatedness of donor, stem cell source, steroid use, total body irradiation use, human leukocyte antigens (HLA) match, or frequency of infection. Results: At 100 days post-HCT, those with aGVHD performed significantly worse on a working memory measure than those without aGvHD. The presence of aGVHD at day 100 increased significantly with every one standard deviation decrease in working memory from baseline to 30 days post-HCT (odds ratio = 3.08; 95% CI: 1.00-9.36). These findings were observed despite a small sample size and statistically controlling for multiple analyses. Conclusions: While this study is exploratory in nature, and has a small sample size, findings suggest that early detection of working memory declines could coincide with, or signal the development of, aGVHD. Potential etiologies are discussed. Implementing early cognitive screening within the first 30 days post-HCT may be useful in identifying patients at risk for aGVHD.",2020,"At 100 days post-HCT, those with aGVHD performed significantly worse on a working memory measure than those without aGvHD.","['Participants were 37 patients undergoing allogeneic HCT, assessed prior to transplant, and at 30- and 100-days post-HCT', 'allogeneic hematopoietic cell transplant']",['Acute graft versus host disease (aGVHD'],"['presence of aGVHD', 'relevant demographic factors, disease, conditioning regimen, relatedness of donor, stem cell source, steroid use, total body irradiation use, human leukocyte antigens (HLA) match, or frequency of infection', 'working memory', 'working memory measure']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0332835', 'cui_str': 'Grafts'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0206152', 'cui_str': 'Cell Transplants'}]","[{'cui': 'C0856825', 'cui_str': 'Acute graft-versus-host disease (disorder)'}]","[{'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0856825', 'cui_str': 'Acute graft-versus-host disease (disorder)'}, {'cui': 'C0011292', 'cui_str': 'Demographic Factors'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0038250', 'cui_str': 'Mother Cells'}, {'cui': 'C4521696', 'cui_str': 'Source (property)'}, {'cui': 'C0038317', 'cui_str': 'Steroids'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0043162', 'cui_str': 'Radiation, Whole-Body'}, {'cui': 'C0019721', 'cui_str': 'HL-A Antigens'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0025265', 'cui_str': 'Working Memory'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}]",100.0,0.0274128,"At 100 days post-HCT, those with aGVHD performed significantly worse on a working memory measure than those without aGvHD.","[{'ForeName': 'John', 'Initials': 'J', 'LastName': 'Stratton', 'Affiliation': 'Department of Psychiatry, Michigan Medicine, Ann Arbor, MI, USA.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Sylvia', 'Affiliation': 'Department of Psychiatry, Michigan Medicine, Ann Arbor, MI, USA.'}, {'ForeName': 'Flora', 'Initials': 'F', 'LastName': 'Hoodin', 'Affiliation': 'Department of Psychiatry, Michigan Medicine, Ann Arbor, MI, USA.'}, {'ForeName': 'Sung Won', 'Initials': 'SW', 'LastName': 'Choi', 'Affiliation': 'Department of Pediatrics, Michigan Medicine, Ann Arbor, MI, USA.'}, {'ForeName': 'Attaphol', 'Initials': 'A', 'LastName': 'Pawarode', 'Affiliation': 'Department of Internal Medicine, Michigan Medicine, Ann Arbor, MI, USA.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Giordani', 'Affiliation': 'Department of Psychiatry, Michigan Medicine, Ann Arbor, MI, USA.'}, {'ForeName': 'Kristen', 'Initials': 'K', 'LastName': 'Votruba', 'Affiliation': 'Department of Psychiatry, Michigan Medicine, Ann Arbor, MI, USA.'}]",The Clinical neuropsychologist,['10.1080/13854046.2019.1672791'] 1298,31624837,Effect of filgotinib on health-related quality of life in active psoriatic arthritis: a randomized phase 2 trial (EQUATOR).,"OBJECTIVE To examine the effects of filgotinib, an oral, selective Janus kinase 1 inhibitor, on health-related quality of life (HRQoL) using the Psoriatic Arthritis Impact of Disease (PsAID)9 questionnaire in active PsA. METHODS Patients were randomized 1 : 1 to filgotinib 200 mg or placebo once daily for 16 weeks in EQUATOR, a multicentre, double-blind, phase 2 randomized controlled trial. HRQoL was assessed with PsAID9 at Weeks 4 and 16. Change from baseline in total and individual domain scores, plus the proportions of patients achieving minimal clinically important improvement (MCII; ⩾3 points) and patient-accepted symptom status (PASS; score <4), were evaluated. Correlation with the 36-item short-form health survey (SF-36) was investigated. RESULTS One hundred and thirty-one patients were randomized to filgotinib or placebo. Filgotinib effects on PsAID9 were observed from Week 4. At Week 16, mean (s.d.) change from baseline in PsAID9 was -2.3 (1.8) and -0.8 (2.2) for filgotinib and placebo, respectively (least-squares mean of group difference -1.48 [95% CI -2.12, -0.84], P < 0.0001), with significant improvements in all domains vs placebo. Significantly more patients on filgotinib achieved MCII (group difference 25.4% [95% CI 8.92, 39.99], P = 0.0022) and PASS (group difference 29.6% [95% CI 10.65, 45.60], P = 0.0018) at Week 16 vs placebo. Similar improvements in SF-36 were observed, with moderate to strong negative correlation between PsAID9 and SF-36. CONCLUSION Filgotinib significantly improved HRQoL vs placebo in patients with active PsA, as measured by PsAID9. To our knowledge, EQUATOR is the first randomized controlled trial to evaluate PsAID9. TRIAL REGISTRATION ClinicalTrials.gov, https://clinicaltrials.gov/ct2/show, NCT03101670.",2020,"Similar improvements in SF-36 were observed, with moderate to strong negative correlation between PsAID9 and SF-36. CONCLUSION Filgotinib significantly improved HRQoL vs placebo in patients with active PsA, as measured by PsAID9.","['Patients', 'One hundred and thirty-one patients', 'active psoriatic arthritis', 'patients with active PsA']","['placebo', 'filgotinib', 'filgotinib or placebo', 'filgotinib 200 mg or placebo']","['HRQoL', 'health-related quality of life', 'PsAID9', 'SF-36', 'filgotinib achieved MCII']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4319552', 'cui_str': '130 (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0003872', 'cui_str': 'Psoriatic Arthropathy'}, {'cui': 'C0201544', 'cui_str': 'Prostate specific antigen measurement (procedure)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4310256', 'cui_str': 'filgotinib'}, {'cui': 'C4319558', 'cui_str': '200'}]","[{'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C4310256', 'cui_str': 'filgotinib'}]",131.0,0.800834,"Similar improvements in SF-36 were observed, with moderate to strong negative correlation between PsAID9 and SF-36. CONCLUSION Filgotinib significantly improved HRQoL vs placebo in patients with active PsA, as measured by PsAID9.","[{'ForeName': 'Ana-Maria', 'Initials': 'AM', 'LastName': 'Orbai', 'Affiliation': 'Division of Rheumatology, Johns Hopkins University School of Medicine, Baltimore, MA.'}, {'ForeName': 'Alexis', 'Initials': 'A', 'LastName': 'Ogdie', 'Affiliation': 'Division of Rheumatology and Center for Clinical Epidemiology and Biostatistics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Laure', 'Initials': 'L', 'LastName': 'Gossec', 'Affiliation': ""Institut Pierre Louis d'Epidémiologie et de Santé Publique, Sorbonne Université.""}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Tillett', 'Affiliation': 'Rheumatology, Royal National Hospital for Rheumatic Diseases.'}, {'ForeName': 'Ying Ying', 'Initials': 'YY', 'LastName': 'Leung', 'Affiliation': 'Department of Rheumatology & Immunology, Singapore General Hospital, Duke-NUS Medical School, Singapore, Singapore.'}, {'ForeName': 'Jingjing', 'Initials': 'J', 'LastName': 'Gao', 'Affiliation': 'Biostatistics.'}, {'ForeName': 'Mona', 'Initials': 'M', 'LastName': 'Trivedi', 'Affiliation': 'Clinical Research, Gilead Sciences, Inc, Foster City, CA, USA.'}, {'ForeName': 'Chantal', 'Initials': 'C', 'LastName': 'Tasset', 'Affiliation': 'Clinical Development.'}, {'ForeName': 'Luc', 'Initials': 'L', 'LastName': 'Meuleners', 'Affiliation': 'Biostatistics, Galapagos NV, Mechelen, Belgium.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Besuyen', 'Affiliation': 'Clinical Development.'}, {'ForeName': 'Thijs', 'Initials': 'T', 'LastName': 'Hendrikx', 'Affiliation': 'Medical Affairs, Galapagos BV, Leiden, Netherlands.'}, {'ForeName': 'Laura C', 'Initials': 'LC', 'LastName': 'Coates', 'Affiliation': 'Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}]","Rheumatology (Oxford, England)",['10.1093/rheumatology/kez408'] 1299,29337835,Promethazine and Oral Midazolam Preanesthetic Children Medication.,"AIMS Several kinds of drugs have been investigated in preschool children as a preanesthetic sedation after various routes of administration for surgeries. This study aims to compare the efficacy of promethazine and oral midazolam for premedication in children aged 3 to 9 years who were scheduled for surgeries. METHODS This is a double-blind randomized controlled study conducted on 93 patients between the age of 3 and 9 years at Loresten University of Medical Sciences Teaching Hospital, Khoramabad, Iran. The subjects were grouped into P (promethazine), M (midazolam), and C (control). About 0.3 mg/kg of oral promethazine was administered to patients in group P, 0.5 mg/kg of oral midazolam was administered to patients in group M, and 3 mL of normal saline as placebo was administered to patients in group C. Patient satisfaction, sedation and emotional score, systolic blood pressure (SBP), diastolic blood pressure, respiratory rate (RR), and heart rate (HR) were recorded. RESULTS There was no statistically significant difference among the 3 groups. However, the period after medication, it was observed that SBP, diastolic blood pressure, RR, and HR in group C were statistically significantly higher than those in groups M and P. These 2 groups are similar in terms of SBP, RR, and HR. The emotional scores were comparable for the 2 groups. It was between 3.97 ± 0.6 to 1.7 ± 0.5 in group M and from 3.45 ± 1.17 to 2.745 ± 0.997 in group P in a Kruskal-Wallis test. CONCLUSIONS This study shows that both test groups reduce stress at the time of anesthetic induction and separation from their parents with similar effect. Both of the anesthetics are easily administered without the necessity of an additional equipment. A shorter period to maximal sedation for midazolam is an advantage, thus, making the drug helpful, mostly in the outpatient setting.",2020,The emotional scores were comparable for the 2 groups.,"['preschool children', 'children aged 3 to 9 years who were scheduled for surgeries', '93 patients between the age of 3 and 9 years at Loresten University of Medical Sciences Teaching Hospital, Khoramabad, Iran']","['midazolam', 'Midazolam Preanesthetic Children Medication', 'Promethazine', 'oral promethazine', 'normal saline as placebo', 'oral midazolam', 'P (promethazine), M (midazolam), and C (control', 'promethazine and oral midazolam']","['satisfaction, sedation and emotional score, systolic blood pressure (SBP), diastolic blood pressure, respiratory rate (RR), and heart rate (HR', 'emotional scores', 'SBP, diastolic blood pressure, RR, and HR', 'SBP, RR, and HR']","[{'cui': 'C0008100', 'cui_str': 'Child, Preschool'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0020027', 'cui_str': 'Teaching Hospitals'}, {'cui': 'C0022065', 'cui_str': 'Islamic Republic of Iran'}]","[{'cui': 'C0026056', 'cui_str': 'Midazolam'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0033405', 'cui_str': 'Promethazine'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}, {'cui': 'C0231832', 'cui_str': 'Respiration Rate'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0911267', 'cui_str': 'SBP protein, Papaver rhoeas'}]",93.0,0.0662825,The emotional scores were comparable for the 2 groups.,"[{'ForeName': 'Sedigheh', 'Initials': 'S', 'LastName': 'Nadri', 'Affiliation': 'From the Departments of Anesthesiology.'}, {'ForeName': 'Hormoz', 'Initials': 'H', 'LastName': 'Mahmoudvand', 'Affiliation': 'Surgery.'}, {'ForeName': 'Nadereh', 'Initials': 'N', 'LastName': 'Taee', 'Affiliation': 'Pediatrics, Faculty of Medicine.'}, {'ForeName': 'Khatereh', 'Initials': 'K', 'LastName': 'Anbari', 'Affiliation': 'Social Determinant of Health Research Center, Lorestan University of Medical Sciences, Khorramabad, Iran.'}, {'ForeName': 'Siavash', 'Initials': 'S', 'LastName': 'Beiranvand', 'Affiliation': 'From the Departments of Anesthesiology.'}]",Pediatric emergency care,['10.1097/PEC.0000000000001389'] 1300,29276837,Effects of Behavioral Activation on the Quality of Life and Emotional State of Lung Cancer and Breast Cancer Patients During Chemotherapy Treatment.,"Research suggests that the progressive abandonment of activities in cancer patients are related to depression and worse quality of life. Behavioral activation (BA) encourages subjects to activate their sources of reinforcement and modify the avoidance responses. This study assesses the effectiveness of BA in improving quality of life and preventing emotional disorders during chemotherapy treatment. One sample of lung cancer patients and another of breast cancer patients were randomized into a BA experimental group (E.G. lung/4sess . n = 50; E.G. breast/6sess . n = 33) and a control group (C.G. lung/4sess . n = 40; C.G. breast/6sess. n = 35), respectively. In each session and in follow-ups (3/6/9 months), all participants completed different assessment scales. The results converge to show the effectiveness of BA, encouraging cancer patients to maintain rewarding activities which can activate their sources of day-to-day reinforcement and modify their experience avoidance patterns. BA appears to be a practical intervention which may improve social and role functioning and the emotional state of cancer patients during chemotherapy treatment.",2019,BA appears to be a practical intervention which may improve social and role functioning and the emotional state of cancer patients during chemotherapy treatment.,"['n = 50', 'lung cancer patients and another of breast cancer patients', 'Lung Cancer and Breast Cancer Patients', 'cancer patients', 'n = 40']","['BA', 'Behavioral Activation']","['Quality of Life and Emotional State', 'quality of life and preventing emotional disorders']","[{'cui': 'C1306460', 'cui_str': 'Primary malignant neoplasm of lung'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}]",[],"[{'cui': 'C0034380'}, {'cui': 'C0684322', 'cui_str': 'Emotional state finding'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0233459', 'cui_str': 'Emotional disorder'}]",,0.0171,BA appears to be a practical intervention which may improve social and role functioning and the emotional state of cancer patients during chemotherapy treatment.,"[{'ForeName': 'Concepción', 'Initials': 'C', 'LastName': 'Fernández-Rodríguez', 'Affiliation': 'University of Oviedo, Spain.'}, {'ForeName': 'Erica', 'Initials': 'E', 'LastName': 'Villoria-Fernández', 'Affiliation': 'Universidad Autónoma de Chile, Chile.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Fernández-García', 'Affiliation': 'University of Oviedo, Spain.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'González-Fernández', 'Affiliation': 'University of Oviedo, Spain.'}, {'ForeName': 'Marino', 'Initials': 'M', 'LastName': 'Pérez-Álvarez', 'Affiliation': 'University of Oviedo, Spain.'}]",Behavior modification,['10.1177/0145445517746915'] 1301,31607677,"Safety of two different doses of simvastatin plus rifaximin in decompensated cirrhosis (LIVERHOPE-SAFETY): a randomised, double-blind, placebo-controlled, phase 2 trial.","BACKGROUND Statins have beneficial effects on intrahepatic circulation and decrease portal hypertension and rifaximin modulates the gut microbiome and might prevent bacterial translocation in patients with cirrhosis. Therefore, this drug combination might be of therapeutic benefit in patients with decompensated cirrhosis. However, there is concern regarding the safety of statins in patients with decompensated cirrhosis. We assessed the safety of two different doses of simvastatin, in combination with rifaximin, in patients with decompensated cirrhosis. METHODS We did a double-blind, randomised, placebo-controlled, phase 2 trial in patients with decompensated cirrhosis and moderate-to-severe liver failure from nine university hospitals in six European countries (Italy, France, Holland, Germany, the UK, and Spain). Patients older than 18 years with Child-Pugh class B or C disease were eligible. We randomly assigned patients (1:1:1) to receive either simvastatin 40 mg/day plus rifaximin 1200 mg/day, simvastatin 20 mg/day plus rifaximin 1200 mg/day, or placebo of both medications for 12 weeks. Randomisation was stratified according to Child-Pugh class (B vs C) and restricted using blocks of multiples of three. The primary endpoint was development of liver or muscle toxicity, as defined by changes in liver aminotransferases (aspartate aminotransferase [AST] and alanine aminotransferase [ALT]), alkaline phosphastase, and creatine kinase. The study is registered with the European Union Clinical Trials Register, 2016-004499-23, and with ClinicalTrials.gov, NCT03150459. FINDINGS The study recruitment period was between July 28, 2017, and Jan 2, 2018. Follow-up finished on March 12, 2018. 50 patients were randomly assigned to simvastatin 40 mg/day plus rifaximin 1200 mg/day (n=18), simvastatin 20 mg/day plus rifaximin 1200 mg/day (n=16), or placebo of both medications (n=16). Six patients (two from each group) were excluded. Therefore, the full analysis set included 44 patients (16 in the simvastatin 40 mg/day plus rifaximin 1200 mg/day group, 14 in the simvastatin 20 mg/day plus rifaximin mg/day group, and 14 in the placebo group). After a safety analyses when the first ten patients completed treatment, treatment was stopped prematurely in the simvastatin 40 mg/day plus rifaximin group due to recommendations by the data safety monitoring board. Patients in the simvastatin 40 mg/day plus rifaximin group showed a significant increase in AST and ALT compared with the placebo group (mean differences between the groups at the end of treatment for AST 130 IU/L [95% CI 54 to 205; p=0·0009] and for ALT 61 IU/L [22 to 100; p=0·0025]. We observed no significant differences at 12 weeks in AST and ALT between the simvastatin 20 mg/day plus rifaximin and placebo group (for AST -14 IU/L [-91 to 64; p=0·728] and for ALT -8 IU/L [-49 to 33; p=0·698]). We observed no significant differences in alkaline phosphatase between the the simvastatin 40 mg/day plus rifaximin or the simvastatin 20 mg/day plus rifaximin groups compared with placebo. Patients in the simvastatin 40 mg/day plus rifaximin group showed an increase in creatine kinase at the end of treatment compared with patients in the placebo group (1009 IU/L [208 to 1809]; p=0·014). We observed no significant changes in creatine kinase in the simvastatin 20 mg/day plus rifaximin group (4·2 IU/L [-804 to 813]; p=0·992). Three (19%) patients in the simvastatin 40 mg/day group developed liver and muscle toxicity consistent with rhabdomyolysis. The number of patients who stopped treatment because of adverse events was significantly higher in the simvastatin 40 mg/day plus rifaximin group (nine [56%] of 16 patients) compared with the other two groups (two [14%] of 14 for both groups; p=0·017). There were no serious unexpected adverse reactions reported during the study. INTERPRETATION Treatment with simvastatin 40 mg/day plus rifaximin in patients with decompensated cirrhosis was associated with a significant increase in adverse events requiring treatment withdrawal, particularly rhabdomyolysis, compared with simvastatin 20 mg/day plus rifaximin. We recommend simvastatin 20 mg/day as the dose to be used in studies investigating the role of statins in patients with decompensated cirrhosis. FUNDING Horizon 20/20 European programme.",2020,We observed no significant differences at 12 weeks in AST and ALT between the simvastatin 20 mg/day plus rifaximin and placebo group (for AST -14 IU/L [-91 to 64; p=0·728] and for ALT -8 IU/L [-49 to 33; p=0·698]).,"['patients with decompensated cirrhosis', '50 patients', 'Six patients (two from each group) were excluded', 'The study recruitment period was between July 28, 2017, and Jan 2, 2018', 'patients with decompensated cirrhosis and moderate-to-severe liver failure from nine university hospitals in six European countries (Italy, France, Holland, Germany, the UK, and Spain', 'Patients older than 18 years with Child', 'patients with cirrhosis', '44 patients (16 in the']","['rifaximin', 'placebo of both medications', 'simvastatin 40 mg/day plus rifaximin 1200 mg/day, simvastatin 20 mg/day plus rifaximin 1200 mg/day, or placebo', 'simvastatin', 'simvastatin 40 mg/day plus rifaximin', 'simvastatin plus rifaximin', 'simvastatin 20 mg/day plus rifaximin', 'placebo']","['creatine kinase', 'adverse events', 'liver and muscle toxicity', 'development of liver or muscle toxicity, as defined by changes in liver aminotransferases (aspartate aminotransferase [AST] and alanine aminotransferase [ALT]), alkaline phosphastase, and creatine kinase', 'alkaline phosphatase', 'adverse reactions', 'AST and ALT']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1619727', 'cui_str': 'Decompensated cirrhosis of liver (disorder)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0085605', 'cui_str': 'Hepatic Failure'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0454713', 'cui_str': 'European country (geographic location)'}, {'cui': 'C0022277', 'cui_str': 'Italy'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0027778', 'cui_str': 'Holland'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1623038', 'cui_str': 'Cirrhosis'}]","[{'cui': 'C0073374', 'cui_str': 'rifaximin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0989916', 'cui_str': 'Simvastatin 40 MG'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C4517548', 'cui_str': 'One thousand two hundred'}, {'cui': 'C0439422', 'cui_str': 'mg/day'}, {'cui': 'C1596096', 'cui_str': 'Simvastatin 20 MG [Zocor]'}, {'cui': 'C0074554', 'cui_str': 'Simvastatin'}]","[{'cui': 'C0201973', 'cui_str': 'Creatine kinase measurement (procedure)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0002594', 'cui_str': 'Aminotransferases'}, {'cui': 'C0004002', 'cui_str': 'L-Aspartate-2-Oxoglutarate Aminotransferase'}, {'cui': 'C0201836', 'cui_str': 'Alanine aminotransferase measurement (procedure)'}, {'cui': 'C0002059', 'cui_str': 'Orthophosphoric-monoester phosphohydrolase (alkaline optimum)'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction (disorder)'}]",44.0,0.284469,We observed no significant differences at 12 weeks in AST and ALT between the simvastatin 20 mg/day plus rifaximin and placebo group (for AST -14 IU/L [-91 to 64; p=0·728] and for ALT -8 IU/L [-49 to 33; p=0·698]).,"[{'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Pose', 'Affiliation': ""Institut D'investigacions Biomèdiques August Pi I Sunyer (IDIBAPS), Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEReHD), Barcelona, Spain; Liver Unit, Hospital Clínic De Barcelona, School of Medicine and Health Sciences University of Barcelona, Barcelona, Spain.""}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Napoleone', 'Affiliation': ""Institut D'investigacions Biomèdiques August Pi I Sunyer (IDIBAPS), Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEReHD), Barcelona, Spain; Liver Unit, Hospital Clínic De Barcelona, School of Medicine and Health Sciences University of Barcelona, Barcelona, Spain.""}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Amin', 'Affiliation': 'Institute of Liver and Digestive Health, University College London, London, UK.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Campion', 'Affiliation': 'Division of Gastroenterology and Hepatology, Città della Salute e della Scienza Hospital, University of Turin, Turin, Italy.'}, {'ForeName': 'César', 'Initials': 'C', 'LastName': 'Jimenez', 'Affiliation': ""Liver Unit, Hospital Vall d'Hebron and Vall d'Hebron Research Unit (VHIR), Universitat Autònoma de Barcelona, Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEReHD), Barcelona, Spain.""}, {'ForeName': 'Salvatore', 'Initials': 'S', 'LastName': 'Piano', 'Affiliation': 'Unit of Internal Medicine and Hepatology (UIMH), Department of Medicine-DIMED, University of Padova, Padova, Italy.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Roux', 'Affiliation': 'Hepatology and Liver Intensive Care Unit, Hospital Beaujon, APHP, Clichy, France.'}, {'ForeName': 'Frank Erhard', 'Initials': 'FE', 'LastName': 'Uschner', 'Affiliation': 'Department of Internal Medicine I, University of Bonn, Bonn, Germany; Department of Internal Medicine I, Goethe University Frankfurt, Frankfurt, Germany.'}, {'ForeName': 'Koos', 'Initials': 'K', 'LastName': 'de Wit', 'Affiliation': 'Department of Gastroenterology and Hepatology, University of Amsterdam, Academic Medical Center, University of Amsterdam, Netherlands.'}, {'ForeName': 'Giacomo', 'Initials': 'G', 'LastName': 'Zaccherini', 'Affiliation': 'Department of Medical and Surgical Sciences, Alma Mater Studiorum University of Bologna, Bologna, Italy.'}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Alessandria', 'Affiliation': 'Division of Gastroenterology and Hepatology, Città della Salute e della Scienza Hospital, University of Turin, Turin, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Angeli', 'Affiliation': 'Unit of Internal Medicine and Hepatology (UIMH), Department of Medicine-DIMED, University of Padova, Padova, Italy.'}, {'ForeName': 'Mauro', 'Initials': 'M', 'LastName': 'Bernardi', 'Affiliation': 'Department of Medical and Surgical Sciences, Alma Mater Studiorum University of Bologna, Bologna, Italy.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Beuers', 'Affiliation': 'Department of Gastroenterology and Hepatology, University of Amsterdam, Academic Medical Center, University of Amsterdam, Netherlands.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Caraceni', 'Affiliation': 'Department of Medical and Surgical Sciences, Alma Mater Studiorum University of Bologna, Bologna, Italy.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Durand', 'Affiliation': 'Hepatology and Liver Intensive Care Unit, Hospital Beaujon, APHP, Clichy, France.'}, {'ForeName': 'Rajeshwar P', 'Initials': 'RP', 'LastName': 'Mookerjee', 'Affiliation': 'Institute of Liver and Digestive Health, University College London, London, UK.'}, {'ForeName': 'Jonel', 'Initials': 'J', 'LastName': 'Trebicka', 'Affiliation': 'Department of Internal Medicine I, University of Bonn, Bonn, Germany; Department of Internal Medicine I, Goethe University Frankfurt, Frankfurt, Germany; European Foundation for the Study of Chronic Liver Failure, Barcelona, Spain; Institute for Bioengineering of Catalonia, Barcelona, Spain.'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Vargas', 'Affiliation': ""Liver Unit, Hospital Vall d'Hebron and Vall d'Hebron Research Unit (VHIR), Universitat Autònoma de Barcelona, Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEReHD), Barcelona, Spain.""}, {'ForeName': 'Raúl J', 'Initials': 'RJ', 'LastName': 'Andrade', 'Affiliation': 'Unidad de Gestión Clínica de Enfermedades Digestivas, Instituto de Investigación Biomédica de Málaga-IBIMA, Hospital Universitario Virgen de la Victoria, Universidad de Málaga, CIBERehd, Málaga, Spain.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Carol', 'Affiliation': ""Institut D'investigacions Biomèdiques August Pi I Sunyer (IDIBAPS), Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEReHD), Barcelona, Spain.""}, {'ForeName': 'Judit', 'Initials': 'J', 'LastName': 'Pich', 'Affiliation': 'Clinical Trials Unit, Clinical Pharmacology Department, Hospital Clínic de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Ferrero', 'Affiliation': 'European Clinical Research Infrastructure Network, Paris, France.'}, {'ForeName': 'Gema', 'Initials': 'G', 'LastName': 'Domenech', 'Affiliation': ""Biostatistics and Data Management Core Facility, Institut D'Investigacions Biomédiques August Pi i Sunyer, Hospital Clinic Barcelona, Spain.""}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Llopis', 'Affiliation': ""Institut D'investigacions Biomèdiques August Pi I Sunyer (IDIBAPS), Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEReHD), Barcelona, Spain.""}, {'ForeName': 'Ferran', 'Initials': 'F', 'LastName': 'Torres', 'Affiliation': ""Biostatistics and Data Management Core Facility, Institut D'Investigacions Biomédiques August Pi i Sunyer, Hospital Clinic Barcelona, Spain.""}, {'ForeName': 'Patrick S', 'Initials': 'PS', 'LastName': 'Kamath', 'Affiliation': 'Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Juan G', 'Initials': 'JG', 'LastName': 'Abraldes', 'Affiliation': 'Cirrhosis Care Clinic, Division of Gastroenterology (Liver Unit), University of Alberta, CEGIIR, Edmonton, AB, Canada.'}, {'ForeName': 'Elsa', 'Initials': 'E', 'LastName': 'Solà', 'Affiliation': ""Institut D'investigacions Biomèdiques August Pi I Sunyer (IDIBAPS), Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEReHD), Barcelona, Spain; Liver Unit, Hospital Clínic De Barcelona, School of Medicine and Health Sciences University of Barcelona, Barcelona, Spain.""}, {'ForeName': 'Pere', 'Initials': 'P', 'LastName': 'Ginès', 'Affiliation': ""Institut D'investigacions Biomèdiques August Pi I Sunyer (IDIBAPS), Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBEReHD), Barcelona, Spain; Liver Unit, Hospital Clínic De Barcelona, School of Medicine and Health Sciences University of Barcelona, Barcelona, Spain. Electronic address: pgines@clinic.cat.""}]",The lancet. Gastroenterology & hepatology,['10.1016/S2468-1253(19)30320-6'] 1302,31628482,"A double-blind, placebo-controlled, phase II, randomized study of lovastatin therapy in the treatment of mildly active rheumatoid arthritis.","OBJECTIVES 3-hydroxy-3-methylglutaryl coenzyme-A (HMG Co-A) reductase inhibitors (statins) are standard treatment for hyperlipidaemia. In addition to lipid-lowering abilities, statins exhibit multiple anti-inflammatory effects. The objectives of this study were to determine whether treatment of patients with RA with lovastatin decreased CRP or reduced disease activity. METHODS We conducted a randomized double-blind placebo-controlled 12 week trial of lovastatin vs placebo in 64 RA patients with mild clinical disease activity but an elevated CRP. The primary efficacy end point was the reduction in mean log CRP. Secondary end points included disease activity, RF and anti-CCP antibody titres. Mechanistic end points included levels of serum cytokines. Safety was assessed; hepatic and muscle toxicities were of particular interest. RESULTS Baseline features were similar between groups. No significant difference in mean log CRP reduction between the two groups was observed, and disease activity did not change from baseline in either treatment group. Mechanistic analyses did not reveal significant changes in any biomarkers. A post hoc analysis of subjects not using biologic therapy demonstrated a significantly greater proportion achieving ⩾20% reduction in CRP from baseline in the lovastatin group compared with placebo (P-value = 0.007). No difference was observed in subjects receiving biologics. Lovastatin was well tolerated with no serious safety concerns. CONCLUSION This study showed no anti-inflammatory or clinical effects on RA disease activity after 12 weeks of treatment with lovastatin. Lovastatin had a modest effect on CRP in subjects not using biologics, suggesting statins may be anti-inflammatory in selected patients. TRIAL REGISTRATION ClinicalTrials.gov, http://clinicaltrials.gov, NCT00302952.",2020,"No significant difference in mean log CRP reduction between the two groups was observed, and disease activity did not change from baseline in either treatment group.","['mildly active rheumatoid arthritis', 'hyperlipidaemia', 'patients with RA with', '64 RA patients with mild clinical disease activity but an elevated CRP']","['lovastatin', '3-hydroxy-3-methylglutaryl coenzyme-A (HMG Co-A) reductase inhibitors (statins', 'lovastatin therapy', 'placebo', 'lovastatin vs placebo', 'Lovastatin']","['mean log CRP', 'CRP', 'hepatic and muscle toxicities', 'mean log CRP reduction', 'disease activity, RF and anti-CCP antibody titres', 'RA disease activity', 'disease activity', 'levels of serum cytokines']","[{'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid Arthritis'}, {'cui': 'C0020473', 'cui_str': 'Hyperlipemia'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}]","[{'cui': 'C0024027', 'cui_str': 'Lovastatin'}, {'cui': 'C0047420', 'cui_str': 'S-(hydrogen 3-hydroxy-3-methylpentanedioate) coenzyme A'}, {'cui': 'C0025326', 'cui_str': 'Gonadotropins, Human Menopausal'}, {'cui': 'C0030016', 'cui_str': 'Reductases'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0360714', 'cui_str': 'Statins'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C4318437', 'cui_str': 'Anti-CCP'}, {'cui': 'C1287242', 'cui_str': 'Finding of antibody titer (finding)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}]",,0.344131,"No significant difference in mean log CRP reduction between the two groups was observed, and disease activity did not change from baseline in either treatment group.","[{'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Aranow', 'Affiliation': 'The Feinstein Institute for Medical Research, Manhasset, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Cush', 'Affiliation': 'Division of Rheumatology, Baylor University Medical Center, Dallas, USA.'}, {'ForeName': 'Marcy B', 'Initials': 'MB', 'LastName': 'Bolster', 'Affiliation': 'Division of Rheumatology, Massachusetts General Hospital, Boston, USA.'}, {'ForeName': 'Christopher C', 'Initials': 'CC', 'LastName': 'Striebich', 'Affiliation': 'Division of Rheumatology, University of Colorado, Denver, USA.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': ""Dall'era"", 'Affiliation': 'Division of Rheumatology, University of California, San Francisco, USA.'}, {'ForeName': 'Meggan', 'Initials': 'M', 'LastName': 'Mackay', 'Affiliation': 'The Feinstein Institute for Medical Research, Manhasset, USA.'}, {'ForeName': 'Ewa', 'Initials': 'E', 'LastName': 'Olech', 'Affiliation': 'Department of Internal Medicine, University of Nevada School of Medicine, Las Vegas, USA.'}, {'ForeName': 'Tracy', 'Initials': 'T', 'LastName': 'Frech', 'Affiliation': 'Department of Internal Medicine, University of Utah, Internal Medicine, Salt Lake City, USA.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Box', 'Affiliation': 'Box Arthritis & Rheumatology of the Carolinas, Charlotte, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Keating', 'Affiliation': 'Division of Rheumatology, Scripps Green Hospital, La Jolla, USA.'}, {'ForeName': 'Mary Chester', 'Initials': 'MC', 'LastName': 'Wasko', 'Affiliation': 'Division of Rheumatology, Western Pennsylvania Hospital, Pittsburgh, USA.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'St Clair', 'Affiliation': 'Division of Rheumatology and Immunology, Duke University School of Medicine, Durham, USA.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Kivitz', 'Affiliation': 'Altoona Center for Clinical Research, Duncansville, USA.'}, {'ForeName': 'Weiquang', 'Initials': 'W', 'LastName': 'Huang', 'Affiliation': 'The Feinstein Institute for Medical Research, Manhasset, USA.'}, {'ForeName': 'PetaGay', 'Initials': 'P', 'LastName': 'Ricketts', 'Affiliation': 'The Feinstein Institute for Medical Research, Manhasset, USA.'}, {'ForeName': 'Beverly', 'Initials': 'B', 'LastName': 'Welch', 'Affiliation': 'National Institute of Allergy and Infectious Diseases, NIH, Bethesda, USA.'}, {'ForeName': 'Sherrie', 'Initials': 'S', 'LastName': 'Callahan', 'Affiliation': 'National Institute of Allergy and Infectious Diseases, NIH, Bethesda, USA.'}, {'ForeName': 'Meagan', 'Initials': 'M', 'LastName': 'Spychala', 'Affiliation': 'Rho Federal Systems Division, Chapel Hill, USA.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Boyle', 'Affiliation': 'Rho Federal Systems Division, Chapel Hill, USA.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'York', 'Affiliation': 'Rho Federal Systems Division, Chapel Hill, USA.'}, {'ForeName': 'Lynette', 'Initials': 'L', 'LastName': 'Keyes-Elstein', 'Affiliation': 'Rho Federal Systems Division, Chapel Hill, USA.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Goldmuntz', 'Affiliation': 'National Institute of Allergy and Infectious Diseases, NIH, Bethesda, USA.'}, {'ForeName': 'Betty', 'Initials': 'B', 'LastName': 'Diamond', 'Affiliation': 'The Feinstein Institute for Medical Research, Manhasset, USA.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Davidson', 'Affiliation': 'The Feinstein Institute for Medical Research, Manhasset, USA.'}]","Rheumatology (Oxford, England)",['10.1093/rheumatology/kez471'] 1303,31628677,Secukinumab for patients failing previous tumour necrosis factor-α inhibitor therapy: results of a randomized open-label study (SIGNATURE).,"BACKGROUND Efficacy data on therapies for patients with psoriasis who have failed tumour necrosis factor (TNF)-α inhibitor therapy is limited. OBJECTIVES To determine the effectiveness and tolerability of secukinumab, an interleukin (IL)-17A inhibitor, in patients with moderate/severe chronic plaque psoriasis with documented efficacy failure of TNF-α inhibitor therapy (SIGNATURE study). METHODS This was a randomized, open-label, noncomparator study in 53 dermatology centres in the U.K. and Republic of Ireland. Patients were randomized 1 : 1 to receive secukinumab 300 mg or 150 mg subcutaneously every week for 4 weeks, then 4-weekly thereafter. Patients were stratified by their prior efficacy failure with TNF-α inhibitors. Only patients who started and stayed on the same dose at each time point were included for efficacy assessments. RESULTS In total, 233 patients were analysed. The primary end point was met, with a statistically significant improvement in response rates [75% reduction in Psoriasis Area and Severity Index (PASI 75)] from baseline to week 16 in both secukinumab 300 mg and 150 mg dose groups [77 of 118 patients (65·3%) and 51 of 115 patients (44·3%), respectively; P < 0·0001]. After 72 weeks, in patients starting and remaining on 300 mg, 77% (54 of 70) achieved PASI 75. Improvements in Dermatology Life Quality Index from baseline to week 16 occurred and were maintained up to 72 weeks. The safety profile was generally consistent with previous secukinumab studies, although a higher incidence of some adverse events (e.g. candida infections) was observed. CONCLUSIONS This study provides evidence of efficacy and safety of secukinumab for treatment of patients with psoriasis who failed prior TNF-α inhibitor therapy. This study represents a 'real-world' population, providing reassurance that secukinumab is a treatment option in this difficult-to-treat population. What's already known about this topic? Conventional systemic nonbiological and tumour necrosis factor (TNF)-α inhibitor therapies for plaque psoriasis have not fully met patients' needs. There is a lack of data to support the treatment pathways for patients with psoriasis who have inadequate responses to TNF-α inhibitor therapy. Secukinumab, a recombinant high-affinity fully human monoclonal anti-human interleukin-17A antibody of the IgG1/κ-class, has shown excellent safety and efficacy in the treatment of moderate-to-severe psoriasis. What does this study add? This is the first study evaluating treatment with biologics after prior efficacy failure of TNF-α inhibitor therapy as defined by the U.K. National Institute for Health and Care Excellence criteria. Secukinumab is an effective treatment in this difficult-to-treat patient population. This study provides important practical information for clinicians managing psoriasis. Adverse events were consistent with the phase III programme for secukinumab, although some adverse events, e.g. candida, were increased.",2020,Improvements in Dermatology Life Quality Index (DLQI) from baseline to Week 16 occurred and maintained up to 72 weeks.,"['psoriasis patients who failed prior TNFα-inhibitor therapy', 'psoriasis patients who have failed tumour necrosis factor (TNF)α-inhibitor therapy is limited', 'patients failing previous TNFα-inhibitor therapy', '53 dermatology centres in UK and Republic of Ireland', '233 patients were analysed', 'patients with moderate/severe chronic plaque psoriasis with documented efficacy failure to TNFα-inhibitor therapy (SIGNATURE Study']","['Secukinumab', 'secukinumab, an IL-17A inhibitor', 'secukinumab']","['Dermatology Life Quality Index (DLQI', 'efficacy and safety', 'response rates', 'Psoriasis Area and Severity Index [PASI75']","[{'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0011627', 'cui_str': 'Dermatology'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0022067', 'cui_str': 'Ireland, Republic of'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0406317', 'cui_str': 'Plaque psoriasis (disorder)'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C3179547', 'cui_str': 'secukinumab'}, {'cui': 'C1705947', 'cui_str': 'CTLA8'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0451112', 'cui_str': 'Dermatology life quality index (assessment scale)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",233.0,0.0458599,Improvements in Dermatology Life Quality Index (DLQI) from baseline to Week 16 occurred and maintained up to 72 weeks.,"[{'ForeName': 'R B', 'Initials': 'RB', 'LastName': 'Warren', 'Affiliation': 'Centre for Dermatology Research, University of Manchester, NIHR Manchester Biomedical Research Centre, Manchester, U.K.'}, {'ForeName': 'J N W B', 'Initials': 'JNWB', 'LastName': 'Barker', 'Affiliation': ""St John's Institute of Dermatology, King's College London, London, U.K.""}, {'ForeName': 'A Y', 'Initials': 'AY', 'LastName': 'Finlay', 'Affiliation': 'Division of Infection and Immunity, Cardiff University, Cardiff, U.K.'}, {'ForeName': 'A D', 'Initials': 'AD', 'LastName': 'Burden', 'Affiliation': 'Centre for Dermatology Research, University of Manchester, NIHR Manchester Biomedical Research Centre, Manchester, U.K.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Kirby', 'Affiliation': ""St Vincent's University Hospital and the Charles Institute, University College Dublin, Dublin, Ireland.""}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Armendariz', 'Affiliation': 'Novartis Pharmaceuticals U.K. Ltd, Frimley, U.K.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Williams', 'Affiliation': 'Novartis Pharmaceuticals U.K. Ltd, Frimley, U.K.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Hatchard', 'Affiliation': 'Novartis Pharmaceuticals U.K. Ltd, Frimley, U.K.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Khare', 'Affiliation': 'Novartis Pharmaceuticals U.K. Ltd, Frimley, U.K.'}, {'ForeName': 'C E M', 'Initials': 'CEM', 'LastName': 'Griffiths', 'Affiliation': 'Centre for Dermatology Research, University of Manchester, NIHR Manchester Biomedical Research Centre, Manchester, U.K.'}]",The British journal of dermatology,['10.1111/bjd.18623'] 1304,31607603,"The effect of increased inoculum on oral rotavirus vaccine take among infants in Dhaka, Bangladesh: A double-blind, parallel group, randomized, controlled trial.","BACKGROUND Oral, live-attenuated rotavirus vaccines suffer from impaired immunogenicity and efficacy in low-income countries. Increasing the inoculum of vaccine might improve vaccine response, but this approach has been inadequately explored in low-income countries. METHODS We performed a double-blind, parallel group, randomized controlled trial from June 2017 through June 2018 in the urban Mirpur slum of Dhaka, Bangladesh to compare vaccine take (primary outcome) among healthy infants randomized to receive either the standard dose or double the standard dose of oral Rotarix (GlaxoSmithKline) vaccine at 6 and 10 weeks of life. Infants with congenital malformations, birth or enrollment weight <2000 gm, known immunocompromising condition, enrollment in another vaccine trial, or other household member enrolled in the study were excluded. Infants were randomized using random permuted blocks. Vaccine take was defined as detection of post-vaccination fecal vaccine shedding by real-time reverse transcription polymerase chain reaction with sequence confirmation or plasma rotavirus-specific immunoglobulin A (RV-IgA) seroconversion 4 weeks following the second dose. RESULTS 220 infants were enrolled and randomized (110 per group). 97 standard-dose and 92 high-dose infants completed the study per-protocol. For the primary outcome, no significant difference was observed between groups: vaccine take occurred in 62 (67%) high-dose infants versus 69 (71%) standard-dose infants (RR 0.92, 95% CI 0.67-1.24). However, in post-hoc analysis, children with confirmed vaccine replication had significantly increased RV-IgA responses, independent of the intervention. No significant adverse events related to study participation were detected. CONCLUSIONS Administration of double the standard dose of an oral, live-attenuated rotavirus vaccine (Rotarix) did not improve vaccine take among infants in urban Dhaka, Bangladesh. However, improved immunogenicity in children with vaccine replication irrespective of initial inoculum provides further evidence for the need to promote in-host replication and improved gut health to improve oral vaccine response in low-income settings. ClinicalTrials.gov: NCT02992197.",2020,"For the primary outcome, no significant difference was observed between groups: vaccine take occurred in 62 (67%) high-dose infants versus 69 (71%) standard-dose infants (RR 0.92, 95% CI 0.67-1.24).","['infants in urban Dhaka, Bangladesh', 'June 2017 through June 2018 in the urban Mirpur slum of Dhaka, Bangladesh to compare vaccine take (primary outcome) among healthy infants', 'Infants with congenital malformations, birth or enrollment weight <2000\u202fgm, known immunocompromising condition, enrollment in another vaccine trial, or other household member enrolled in the study were excluded', '220 infants were enrolled and randomized (110 per group', 'infants in Dhaka, Bangladesh']","['standard dose or double the standard dose of oral Rotarix (GlaxoSmithKline) vaccine', 'live-attenuated rotavirus vaccine (Rotarix']","['vaccine take', 'RV-IgA responses']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0004732', 'cui_str': 'Bangladesh'}, {'cui': 'C0037345', 'cui_str': 'Slums'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0000768', 'cui_str': 'Birth Defects'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C0205309', 'cui_str': 'Known (qualifier value)'}, {'cui': 'C0085393', 'cui_str': 'Immunosuppressed Host'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C4517650', 'cui_str': '220 (qualifier value)'}, {'cui': 'C4517536', 'cui_str': '110 (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C1528012', 'cui_str': 'Rotarix'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0597418', 'cui_str': 'Rotavirus Vaccines'}]","[{'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0020835', 'cui_str': 'Immunoglobulin A'}]",220.0,0.749609,"For the primary outcome, no significant difference was observed between groups: vaccine take occurred in 62 (67%) high-dose infants versus 69 (71%) standard-dose infants (RR 0.92, 95% CI 0.67-1.24).","[{'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Lee', 'Affiliation': 'UVM Vaccine Testing Center and Department of Pediatrics, University of Vermont Larner College of Medicine, Burlington, VT 05405, USA. Electronic address: blee7@uvm.edu.'}, {'ForeName': 'Dorothy M', 'Initials': 'DM', 'LastName': 'Dickson', 'Affiliation': 'UVM Vaccine Testing Center and Department of Microbiology and Molecular Genetics, University of Vermont Larner College of Medicine, Burlington, VT 05405, USA.'}, {'ForeName': 'Masud', 'Initials': 'M', 'LastName': 'Alam', 'Affiliation': 'Centre for Vaccine Science and Parasitology Lab, International Centre for Diarrhoeal Disease Research, Bangladesh, Dhaka 1212, Bangladesh.'}, {'ForeName': 'Sajia', 'Initials': 'S', 'LastName': 'Afreen', 'Affiliation': 'Centre for Vaccine Science and Parasitology Lab, International Centre for Diarrhoeal Disease Research, Bangladesh, Dhaka 1212, Bangladesh.'}, {'ForeName': 'Abdul', 'Initials': 'A', 'LastName': 'Kader', 'Affiliation': 'Centre for Vaccine Science and Parasitology Lab, International Centre for Diarrhoeal Disease Research, Bangladesh, Dhaka 1212, Bangladesh.'}, {'ForeName': 'Faria', 'Initials': 'F', 'LastName': 'Afrin', 'Affiliation': 'Centre for Vaccine Science and Parasitology Lab, International Centre for Diarrhoeal Disease Research, Bangladesh, Dhaka 1212, Bangladesh.'}, {'ForeName': 'Tania', 'Initials': 'T', 'LastName': 'Ferdousi', 'Affiliation': 'Centre for Vaccine Science and Parasitology Lab, International Centre for Diarrhoeal Disease Research, Bangladesh, Dhaka 1212, Bangladesh.'}, {'ForeName': 'Christina F', 'Initials': 'CF', 'LastName': 'Damon', 'Affiliation': 'UVM Vaccine Testing Center and Department of Microbiology and Molecular Genetics, University of Vermont Larner College of Medicine, Burlington, VT 05405, USA.'}, {'ForeName': 'Soyeon K', 'Initials': 'SK', 'LastName': 'Gullickson', 'Affiliation': 'UVM Vaccine Testing Center and Department of Microbiology and Molecular Genetics, University of Vermont Larner College of Medicine, Burlington, VT 05405, USA.'}, {'ForeName': 'Monica M', 'Initials': 'MM', 'LastName': 'McNeal', 'Affiliation': ""Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, OH, USA; Division of Infectious Diseases, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.""}, {'ForeName': 'Daniel M', 'Initials': 'DM', 'LastName': 'Bak', 'Affiliation': 'UVM Vaccine Testing Center and Department of Microbiology and Molecular Genetics, University of Vermont Larner College of Medicine, Burlington, VT 05405, USA.'}, {'ForeName': 'Mona', 'Initials': 'M', 'LastName': 'Tolba', 'Affiliation': 'UVM Vaccine Testing Center and Department of Microbiology and Molecular Genetics, University of Vermont Larner College of Medicine, Burlington, VT 05405, USA.'}, {'ForeName': 'Marya P', 'Initials': 'MP', 'LastName': 'Carmolli', 'Affiliation': 'UVM Vaccine Testing Center and Department of Microbiology and Molecular Genetics, University of Vermont Larner College of Medicine, Burlington, VT 05405, USA.'}, {'ForeName': 'Mami', 'Initials': 'M', 'LastName': 'Taniuchi', 'Affiliation': 'Division of Infectious Diseases and International Health, Department of Medicine, University of Virginia, Charlottesville, VA 22908, USA.'}, {'ForeName': 'Rashidul', 'Initials': 'R', 'LastName': 'Haque', 'Affiliation': 'Centre for Vaccine Science and Parasitology Lab, International Centre for Diarrhoeal Disease Research, Bangladesh, Dhaka 1212, Bangladesh.'}, {'ForeName': 'Beth D', 'Initials': 'BD', 'LastName': 'Kirkpatrick', 'Affiliation': 'UVM Vaccine Testing Center and Department of Microbiology and Molecular Genetics, University of Vermont Larner College of Medicine, Burlington, VT 05405, USA.'}]",Vaccine,['10.1016/j.vaccine.2019.09.088'] 1305,29173816,The Prediction of Body Composition in African Americans From Spine and Hip Dual-Energy Absorptiometry.,"Body composition, the makeup of the body's fat and lean tissue, is associated with important health outcomes and provides useful clinical information. Although body composition can be measured with total body dual-energy X-ray absorptiometry (DXA), this is rarely performed. As an alternative to total body DXA measurement, methods for estimation of body composition have been developed. These methods use soft tissue measures from spine and hip DXA to predict body composition and include prediction equations previously published by Leslie and proprietary equations within General Electric densitometry software. However, these estimates have not been tested in African Americans (AA), an ethnicity with a different distribution of fat than Caucasians (CA). Therefore, we examined the performance of the existing models in 99 CA and 162 AA subjects over the age of 40 who had total body, spine, and hip DXA measurements. We observed that existing models estimated body composition well in CA but underestimated fat mass and overestimated lean mass in AA. AA subjects were then randomly divided into 2 equal-sized subgroups-the first to develop new prediction equations and the second to independently validate them. We found that body composition can be more accurately estimated using either a new model that we derived in AA subjects using backward stepwise elimination or by adding a fixed offset for AA to the previously published model. Our results demonstrate that body composition estimates from spine and hip DXA require consideration of race/ethnicity.",2019,We found that body composition can be more accurately estimated using either a new model that we derived in AA subjects using backward stepwise elimination or by adding a fixed offset for AA to the previously published model.,"['African Americans From Spine and Hip Dual-Energy Absorptiometry', 'AA subjects', 'African Americans (AA', '99 CA and 162 AA subjects over the age of 40 who had total body, spine, and hip DXA measurements']",[],['Body Composition'],"[{'cui': 'C0037949', 'cui_str': 'Spinal Column'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}]",[],"[{'cui': 'C0005885', 'cui_str': 'Body Composition'}]",,0.0178593,We found that body composition can be more accurately estimated using either a new model that we derived in AA subjects using backward stepwise elimination or by adding a fixed offset for AA to the previously published model.,"[{'ForeName': 'Rajesh K', 'Initials': 'RK', 'LastName': 'Jain', 'Affiliation': 'Department of Medicine, Section of Endocrinology, Diabetes and Metabolism, University of Chicago, Chicago, Illinois. Electronic address: rajesh.jain@tuhs.temple.edu.'}, {'ForeName': 'Tamara', 'Initials': 'T', 'LastName': 'Vokes', 'Affiliation': 'Department of Medicine, Section of Endocrinology, Diabetes and Metabolism, University of Chicago, Chicago, Illinois.'}]",Journal of clinical densitometry : the official journal of the International Society for Clinical Densitometry,['10.1016/j.jocd.2017.10.040'] 1306,29262693,A Randomized Controlled Trial of Multiple Versions of an Acceptance and Commitment Therapy Matrix App for Well-Being.,"Mobile apps may be useful in teaching psychological skills in a high-frequency, low-intensity intervention. The acceptance and commitment therapy (ACT) matrix is a visual tool to help develop psychological flexibility by categorizing moment-to-moment experience and is well suited to a mobile app. This pilot study tested the effects of a simple and complex version of a novel app using the ACT matrix in two distinct samples: help-seeking individuals ( n = 35) and students receiving SONA credit ( n = 63). Findings indicated no differences between app conditions and a waitlist condition in the SONA credit sample. However, in the help-seeking sample, improvements were found on well-being and valued action in participants who used the app, with greater improvements and app adoption for those using a complex version with additional skills. A mobile app based on the ACT matrix has benefits for help-seeking individuals, but supplementary features may be necessary to support consistent use and benefits.",2019,"However, in the help-seeking sample, improvements were found on well-being and valued action in participants who used the app, with greater improvements and app adoption for those using a complex version with additional skills.",['two distinct samples: help-seeking individuals ( n = 35) and students receiving SONA credit ( n = 63'],"['simple and complex version of a novel app using the ACT matrix', 'ACT matrix']",[],"[{'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}]","[{'cui': 'C0205352', 'cui_str': 'Simple (qualifier value)'}, {'cui': 'C0439855', 'cui_str': 'Complex (qualifier value)'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C4319583', 'cui_str': 'Matrix'}]",[],63.0,0.0482813,"However, in the help-seeking sample, improvements were found on well-being and valued action in participants who used the app, with greater improvements and app adoption for those using a complex version with additional skills.","[{'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Krafft', 'Affiliation': 'Utah State University, Logan, UT, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Potts', 'Affiliation': 'Utah State University, Logan, UT, USA.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Schoendorff', 'Affiliation': 'Contextual Psychology Institute, Mont-Saint-Hilaire, Quebec, Canada.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Levin', 'Affiliation': 'Utah State University, Logan, UT, USA.'}]",Behavior modification,['10.1177/0145445517748561'] 1307,29231046,An Assessment of the Effects of Hydrotherapy During the Active Phase of Labor on the Labor Process and Parenting Behavior.,"This study was conducted to assess the effect on labor process and parenting behavior of hydrotherapy applied during the active phase of labor. This quasi-experimental study was conducted by using an equivalent comparison group ( n = 40). The participants in the experimental group whose cervical dilation was 5 cm were taken to the hydrotherapy tub. This application continued until cervical dilation reached 10 cm. The Participants Questionnaire, The Birth Follow-up Questionnaire, The Postpartum ]collection tools. The duration of the active phase and second stage of labor was extremely short in the experimental group in comparison with the equivalent comparison group ( p = .001). The Visual Analogue Scale (VAS) scores of the experimental group were lower than those of the equivalent comparison group when cervical dilation was 6 cm and 10 cm ( p = .001). The experimental group also displayed more positive parenting behavior and positive labor feeling ( p = .001).",2019,The duration of the active phase and second stage of labor was extremely short in the experimental group in comparison with the equivalent comparison group ( p = .001).,[],['Hydrotherapy'],"['cervical dilation', 'Visual Analogue Scale (VAS) scores', 'duration of the active phase and second stage of labor', 'positive parenting behavior and positive labor feeling']",[],"[{'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}]","[{'cui': 'C0205064', 'cui_str': 'Cervical (qualifier value)'}, {'cui': 'C1322279', 'cui_str': 'Dilation'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0022872', 'cui_str': 'Labor Stage, Second'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0022864', 'cui_str': 'Labor, Obstetric'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}]",40.0,0.0256603,The duration of the active phase and second stage of labor was extremely short in the experimental group in comparison with the equivalent comparison group ( p = .001).,"[{'ForeName': 'Semra', 'Initials': 'S', 'LastName': 'Tuncay', 'Affiliation': ""Zekai Tahir Burak Women's Health Education and Research Hospital, Ankara, Turkey.""}, {'ForeName': 'Sena', 'Initials': 'S', 'LastName': 'Kaplan', 'Affiliation': 'Yildirim Beyazit University, Ankara, Turkey.'}, {'ForeName': 'Ozlem', 'Initials': 'O', 'LastName': 'Moraloglu Tekin', 'Affiliation': ""Etlik Zubeyde Hanim Women's Health Education and Research Hospital, Ankara, Turkey.""}]",Clinical nursing research,['10.1177/1054773817746893'] 1308,31609315,"A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition.","Limited evidence exists to precisely estimate efficacy and safety differences between parenteral nutrition (PN) prepared using olive-oil-based three-chamber bags (3CBs) and soybean-oil-based compounded bags (CoBs) in hospitalized adult patients. We designed a multicenter, randomized, prospective, open-label, noninferiority protocol to compare the efficacy, safety, and distribution of olive-oil-based 3CBs and soybean-oil-based CoB formulations in adult Chinese patients requiring PN during surgical intervention. Subjects were randomized to receive either one of the study treatments using an interactive voice or web-based recognition system in accordance with the randomization code. Randomization was further stratified based on the study site and surgical category. Both treatment groups received similar amounts of calories and protein. In addition, the two study treatments contained a similar composition of the amino-acid component. The only difference between the two PN formulations was the lipid constitution. The duration of administration of study treatments was a minimum of 5 days up to a maximum of 14 days after the surgical procedure. The primary efficacy endpoint was serum prealbumin levels on day 5 of the study. Noninferiority was proved if the anti-log of the lower bound of the 95% confidence interval (CI) of the treatment difference was at least 0.80. Other efficacy measures included treatment preparation time; duration to achieve tolerability of oral nutrition; associated infectious complications; length of hospitalization; and laboratory assessment of markers of nutrition, inflammation, metabolism, and oxidative stress. A total of 458 patients were enrolled in the study. The results showed that olive-oil-based 3CBs were non-inferior to soybean-based CoBs, besides being well tolerated. The infection rate was found to be significantly lower in the olive-oil-based 3CB group. Thus, this study may be used as a reference for future research on lipid emulsion and 3CBs.",2019,The infection rate was found to be significantly lower in the olive-oil-based 3CB group.,"['A total of 458 patients were enrolled in the study', 'hospitalized adult patients', 'adult Chinese patients requiring PN during surgical intervention']","['Olive-Oil-Based Three-Chamber Bags', 'olive-oil-based 3CBs', 'parenteral nutrition (PN) prepared using olive-oil-based three-chamber bags (3CBs) and soybean-oil-based compounded bags (CoBs', 'olive-oil-based 3CBs and soybean-oil-based CoB formulations', 'interactive voice or web-based recognition system']","['infection rate', 'tolerability of oral nutrition; associated infectious complications; length of hospitalization; and laboratory assessment of markers of nutrition, inflammation, metabolism, and oxidative stress', 'serum prealbumin levels']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0549433', 'cui_str': 'Surgical intervention'}]","[{'cui': 'C0069449', 'cui_str': 'olive oil'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1706249', 'cui_str': 'Bag - unit of product usage (qualifier value)'}, {'cui': 'C0030547', 'cui_str': 'Parenteral Nutrition'}, {'cui': 'C4082130', 'cui_str': 'Prepared (qualifier value)'}, {'cui': 'C0037732', 'cui_str': 'Soybean Oil'}, {'cui': 'C0205198', 'cui_str': 'Compound (qualifier value)'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0524637', 'cui_str': 'Recognition (Psychology)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}]","[{'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0025520', 'cui_str': 'metabolism'}, {'cui': 'C0242606', 'cui_str': 'Oxidative Stress'}, {'cui': 'C1273508', 'cui_str': 'Serum prealbumin level'}]",458.0,0.0521304,The infection rate was found to be significantly lower in the olive-oil-based 3CB group.,"[{'ForeName': 'Zhenyi', 'Initials': 'Z', 'LastName': 'Jia', 'Affiliation': ""Department of General Surgery, Shanghai Jiao Tong University Affiliated Sixth People's Hospital.""}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': ""Department of General Surgery, Shanghai Jiao Tong University Affiliated Sixth People's Hospital.""}, {'ForeName': 'Huanlong', 'Initials': 'H', 'LastName': 'Qin', 'Affiliation': ""Department of General Surgery, Shanghai Jiao Tong University Affiliated Sixth People's Hospital; Department of General Surgery, Shanghai Tenth People's Hospital Affiliated to Tongji University; hlqin65@163.com.""}]",Journal of visualized experiments : JoVE,['10.3791/57956'] 1309,31608773,Functional ability is associated with higher adherence to behavioral interventions in mild cognitive impairment.,"Objective: Behavioral interventions during early memory decline hold promise in delaying the development of dementia. In the present study, participants in a multimodal behavioral intervention study were assessed for post-intervention adherence and predictors of adherence. Methods: Participants ( N  = 272, mean age = 75.04 ± 7.54) diagnosed with amnestic Mild Cognitive Impairment (aMCI) were assigned to intervention groups receiving four out of five behavioral intervention components, including yoga, memory compensation training, computerized cognitive training, support groups, and/or wellness education. Length of the intervention was 10 days, 4 h per day, with post-intervention follow-up at 6, 12, and 18 months. Results: Two-hundred and thirty-seven participants completed the 6-month post-intervention follow-up measures, 228 participants completed the 12-month measures, and 218 participants completed the 18-month measures. Participants fully adhered to a mean of 2 out of the 4 taught intervention components. Eighty-nine percent of participants were at least partially adherent to one or more taught intervention components at 6-, 12-, and 18-month post-intervention follow-up. Physical activity was the most adhered to intervention while group support was the least adhered to intervention across all three follow-up time-points. Higher educational level, higher baseline depressive symptoms, higher baseline global cognitive functioning, and better baseline and concurrent functional abilities were associated post-intervention adherence. Conclusion: Changes in functional abilities are associated with disease progression among persons with aMCI. In the present study, individuals with aMCI who have higher education, higher depressive symptoms, and better baseline functioning abilities are more likely to adhere to behavioral intervention components over time. Post-intervention adherence also associates with concurrent daily function.",2020,Physical activity was the most adhered to intervention while group support was the least adhered to intervention across all three follow-up time-points.,"['persons with aMCI', 'mild cognitive impairment', 'Eighty-nine percent of participants were at least partially adherent to one or more taught intervention components at 6-, 12-, and 18-month post-intervention follow-up', 'Participants ( N \u2009=\u2009272', 'individuals with aMCI who have higher education, higher depressive symptoms', 'Two-hundred and thirty-seven participants completed the 6-month post-intervention follow-up measures, 228 participants completed the 12-month measures, and 218 participants completed the 18-month measures', 'mean age\u2009=\u200975.04\u2009±\u20097.54) diagnosed with amnestic Mild Cognitive Impairment (aMCI']","['Behavioral interventions', 'behavioral intervention components, including yoga, memory compensation training, computerized cognitive training, support groups, and/or wellness education']","['Physical activity', 'Higher educational level, higher baseline depressive symptoms, higher baseline global cognitive functioning, and better baseline and concurrent functional abilities']","[{'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C1270972', 'cui_str': 'Mild Neurocognitive Disorder'}, {'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C0439165', 'cui_str': 'Percent (property) (qualifier value)'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0424933', 'cui_str': 'Higher education (finding)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C4319569', 'cui_str': '37 (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C4517647', 'cui_str': 'Two hundred and eighteen'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0152058', 'cui_str': 'Compensation (finding)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0036606', 'cui_str': 'Support Groups'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0205420', 'cui_str': 'Concurrent (qualifier value)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0085732', 'cui_str': 'Ability'}]",237.0,0.0943486,Physical activity was the most adhered to intervention while group support was the least adhered to intervention across all three follow-up time-points.,"[{'ForeName': 'Priscilla A Amofa', 'Initials': 'PAA', 'LastName': 'Sr', 'Affiliation': 'Department of Clinical and Health Psychology, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Brittany', 'Initials': 'B', 'LastName': 'DeFeis', 'Affiliation': 'Department of Clinical and Health Psychology, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Liselotte', 'Initials': 'L', 'LastName': 'De Wit', 'Affiliation': 'Department of Clinical and Health Psychology, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Deirdre', 'Initials': 'D', 'LastName': ""O'Shea"", 'Affiliation': 'Department of Clinical and Health Psychology, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Mejia', 'Affiliation': 'Department of Clinical and Health Psychology, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Chandler', 'Affiliation': 'Department of Psychiatry and Psychology, Mayo Clinic Florida, Jacksonville, FL, USA.'}, {'ForeName': 'Dona E C', 'Initials': 'DEC', 'LastName': 'Locke', 'Affiliation': 'Department of Psychiatry and Psychology, Mayo Clinic Arizona, Scottsdale, AZ, USA.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Fields', 'Affiliation': 'Department of Psychiatry and Psychology, Mayo Clinic Minnesota, Rochester, MN, USA.'}, {'ForeName': 'Vaishali', 'Initials': 'V', 'LastName': 'Phatak', 'Affiliation': 'Department of Neurological Sciences, University of Nebraska Medical Center, Omaha, NE, USA.'}, {'ForeName': 'Pamela M', 'Initials': 'PM', 'LastName': 'Dean', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Crook', 'Affiliation': 'Division of Biomedical Statistics and Informatics, Mayo Clinic Florida, Jacksonville, FL, USA.'}, {'ForeName': 'Glenn', 'Initials': 'G', 'LastName': 'Smith', 'Affiliation': 'Department of Clinical and Health Psychology, University of Florida, Gainesville, FL, USA.'}]",The Clinical neuropsychologist,['10.1080/13854046.2019.1672792'] 1310,29140227,Categorical improvement in functional impairment in depressed patients treated with desvenlafaxine.,"OBJECTIVE This post-hoc pooled analysis evaluated categorical change in functional impairment in patients with major depressive disorder (MDD) treated with desvenlafaxine versus placebo and examined whether early improvement in functioning predicted functional outcomes at study endpoint. METHODS Data were pooled from eight randomized, double-blind, placebo-controlled studies of desvenlafaxine for the treatment of MDD, including adults who were randomly assigned to receive desvenlafaxine 50 or 100 mg/d or placebo (N=3,384). Shift tables were generated for categorical changes in functional impairment from baseline based on Sheehan Disability Scale (SDS) subscale scores. The categories were none/mild (0-3), moderate (4-6), and marked/extreme (7-10). Treatment comparisons for prespecified shifts of interest and predictive value of week 2 or 4 improvement in SDS subscale scores for functional outcome at week 8 were assessed using logistic regression. RESULTS Greater proportions of patients receiving desvenlafaxine 50 and 100 mg achieved improvement from baseline to week 8 for each prespecified shift endpoint versus placebo (all p ≤ 0.02). Early improvement in SDS subscale scores was a statistically significant predictor of functional outcome at week 8, both overall and for each treatment group (all p<0.0001). CONCLUSIONS Treatment with desvenlafaxine 50 or 100 mg/d led to significantly greater categorical improvement in functional impairment versus placebo, and improvement in SDS subscale scores significantly predicted functional outcome. Monitoring patient progress early in the course of antidepressant treatment using a functional assessment such as the SDS may help clinicians determine whether or not treatment adjustments are needed.",2019,"Early improvement in SDS subscale scores was a statistically significant predictor of functional outcome at week 8, both overall and for each treatment group (all p<0.0001). ",['patients with major depressive disorder (MDD) treated with'],"['desvenlafaxine versus placebo', 'desvenlafaxine 50 or 100 mg/d or placebo', 'placebo', 'desvenlafaxine']","['functional impairment', 'Sheehan Disability Scale (SDS) subscale scores', 'SDS subscale scores']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}]","[{'cui': 'C1880288', 'cui_str': 'Desvenlafaxine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}]","[{'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C4720840', 'cui_str': 'Sheehan disability scale'}, {'cui': 'C0459443', 'cui_str': 'Subscale score (qualifier value)'}]",,0.13224,"Early improvement in SDS subscale scores was a statistically significant predictor of functional outcome at week 8, both overall and for each treatment group (all p<0.0001). ","[{'ForeName': 'Claudio N', 'Initials': 'CN', 'LastName': 'Soares', 'Affiliation': ""1Professor of Psychiatry,Queen's University School of Medicine,Kingston,Ontario,Canada.""}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Zhang', 'Affiliation': '3Director of Clinical Statistics,Pfizer Inc,New York,New York,United States.'}, {'ForeName': 'Matthieu', 'Initials': 'M', 'LastName': 'Boucher', 'Affiliation': '4Medical Affairs,Pfizer Canada Inc,Kirkland,Quebec,Canada.'}]",CNS spectrums,['10.1017/S1092852917000633'] 1311,31601496,"Patient-reported outcomes with durvalumab after chemoradiotherapy in stage III, unresectable non-small-cell lung cancer (PACIFIC): a randomised, controlled, phase 3 study.","BACKGROUND In the ongoing, phase 3 PACIFIC trial, durvalumab improved the primary endpoints of progression-free survival and overall survival compared with that for placebo, with similar safety, in patients with unresectable, stage III non-small-cell lung cancer. In this analysis, we aimed to evaluate one of the secondary endpoints, patient-reported outcomes (PROs). METHODS PACIFIC is an ongoing, international, multicentre, double-blind, randomised, controlled, phase 3 trial. Eligible patients were aged at least 18 years, had a WHO performance status of 0 or 1, with histologically or cytologically documented stage III, unresectable non-small-cell lung cancer, for which they had received at least two cycles of platinum-based chemoradiotherapy, with no disease progression after this treatment. We randomly assigned patients (2:1) using an interactive voice response system and a blocked design (block size=3) stratified by age, sex, and smoking history to receive 10 mg/kg intravenous durvalumab or matching placebo 1-42 days after concurrent chemoradiotherapy, then every 2 weeks up to 12 months. The primary endpoints of progression-free survival and overall survival have been reported previously. PROs were a prespecified secondary outcome. We assessed PRO symptoms, functioning, and global health status or quality of life in the intention-to-treat population with the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) version 3 and its lung cancer module, the Quality of Life Questionnaire-Lung Cancer 13 (QLQ-LC13) at the time of random allocation to groups, at weeks 4 and 8, every 8 weeks until week 48, and then every 12 weeks until progression. Changes from baseline to 12 month in key symptoms were analysed with mixed model for repeated measures (MMRM) and time-to-event analyses. A 10-point or greater change from baseline (deterioration or improvement) was deemed clinically relevant. This study is registered with ClinicalTrials.gov, NCT02125461, and EudraCT, 2014-000336-42. FINDINGS Between May 9, 2014, and April 22, 2016, 476 patients were assigned to receive durvalumab, and 237 patients were assigned to receive placebo. As of March 22, 2018, the median follow-up was 25·2 months (IQR 14·1-29·5). More than 79% of patients given durvalumab and more than 82% of patients given placebo completed questionnaires up to week 48. Between baseline and 12 months, the prespecified longitudinal PROs of interest, cough (MMRM-adjusted mean change 1·8 [95% CI 0·06 to 3·54] in the durvalumab group vs 0·7 [-1·91 to 3·30] in the placebo group), dyspnoea (3·1 [1·75 to 4·36] vs 1·4 [-0·51 to 3·34]), chest pain (-3·1 [-4·57 to -1·60] vs -3·5 [-5·68 to -1·29]), fatigue (-3·0 [-4·53 to -1·50] vs -5·2 [-7·45 to -2·98]), appetite loss (-5·8 [-7·28 to -4·36] vs -7·0 [-9·17 to -4·87]), physical functioning (0·1 [-1·10 to 1·28] vs 2·0 [0·22 to 3·73]), and global health status or quality of life (2·6 [1·21 to 3·94] vs 1·8 [-0·25 to 3·81]) remained stable with both treatments, with no clinically relevant changes from baseline. The between-group differences in changes from baseline to 12 months in cough (difference in adjusted mean changes 1·1, 95% CI -1·89 to 4·11), dyspnoea (1·6, -0·58 to 3·87), chest pain (0·4, -2·13 to 2·93), fatigue (2·2, -0·38 to 4·78), appetite loss (1·2, -1·27 to 3·67), physical functioning (-1·9, -3·91 to 0·15), or global health status or quality of life (0·8, -1·55 to 3·14) were not clinically relevant. Generally, there were no clinically important between-group differences in time to deterioration of prespecified key PRO endpoints. INTERPRETATION Our findings suggest that a clinical benefit with durvalumab can be attained without compromising PROs. This result is of note because the previous standard of care was observation alone, with no presumed detriment to PROs. FUNDING AstraZeneca.",2019,More than 79% of patients given durvalumab and more than 82% of patients given placebo completed questionnaires up to week 48.,"['1·8', 'Between May 9, 2014, and April 22, 2016', 'Eligible patients were aged at least 18 years, had a WHO performance status of 0 or 1, with histologically or cytologically documented stage III, unresectable non-small-cell lung cancer, for which they had received at least two cycles of platinum-based chemoradiotherapy, with no disease progression after this treatment', 'stage III, unresectable non-small-cell lung cancer (PACIFIC', '476 patients were assigned to receive durvalumab, and 237 patients', 'patients with unresectable, stage III non-small-cell lung cancer']","['interactive voice response system and a blocked design (block size=3) stratified by age, sex, and smoking history to receive 10 mg/kg intravenous durvalumab or matching placebo', '4·36', 'placebo', 'durvalumab after chemoradiotherapy', '3·5']","['appetite loss (-5·8', 'global health status or quality of life (2·6', 'Quality of Life Questionnaire-Core 30 (QLQ-C30) version 3 and its lung cancer module, the Quality of Life Questionnaire-Lung Cancer 13 (QLQ-LC13', 'PRO symptoms, functioning, and global health status or quality of life in the intention-to-treat population with the European Organisation for Research and Treatment of Cancer (EORTC', 'dyspnoea ', 'prespecified longitudinal PROs of interest, cough (MMRM-adjusted mean change', 'progression-free survival and overall survival', 'physical functioning (0·1', 'dyspnoea (1·6, -0·58 to 3·87), chest pain (0·4, -2·13 to 2·93), fatigue (2·2, -0·38 to 4·78), appetite loss (1·2, -1·27 to 3·67), physical functioning (-1·9, -3·91 to 0·15), or global health status or quality of life', 'chest pain']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3 (qualifier value)'}, {'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0242656', 'cui_str': 'Disease Progression'}, {'cui': 'C0231290', 'cui_str': 'Status post (contextual qualifier) (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C4055109', 'cui_str': 'durvalumab'}]","[{'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0205363', 'cui_str': 'Stratified (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0019665', 'cui_str': 'historical aspects'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C4055109', 'cui_str': 'durvalumab'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}]","[{'cui': 'C0003618', 'cui_str': 'Appetite'}, {'cui': 'C1456573', 'cui_str': 'Global Health'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0034380'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0444669', 'cui_str': 'Core (qualifier value)'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C1306460', 'cui_str': 'Primary malignant neoplasm of lung'}, {'cui': 'C3542953', 'cui_str': 'Module (core metadata concept)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0239307', 'cui_str': 'European (ethnic group)'}, {'cui': 'C0029237', 'cui_str': 'Organization (morphologic abnormality)'}, {'cui': 'C0035168'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0013404', 'cui_str': 'Breathlessness'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal (qualifier value)'}, {'cui': 'C0010200', 'cui_str': 'Complaining of cough (finding)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0008031', 'cui_str': 'Chest Pain'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}]",476.0,0.450892,More than 79% of patients given durvalumab and more than 82% of patients given placebo completed questionnaires up to week 48.,"[{'ForeName': 'Rina', 'Initials': 'R', 'LastName': 'Hui', 'Affiliation': 'Department of Medical Oncology, Westmead Hospital and the University of Sydney, Sydney, NSW, Australia. Electronic address: rina.hui@sydney.edu.au.'}, {'ForeName': 'Mustafa', 'Initials': 'M', 'LastName': 'Özgüroğlu', 'Affiliation': 'Division of Medical Oncology, Department of Internal Medicine, Cerrahpaşa School of Medicine, Istanbul University Cerrahpaşa, Istanbul, Turkey.'}, {'ForeName': 'Augusto', 'Initials': 'A', 'LastName': 'Villegas', 'Affiliation': 'Cancer Specialists of North Florida, Jacksonville, FL, USA.'}, {'ForeName': 'Davey', 'Initials': 'D', 'LastName': 'Daniel', 'Affiliation': 'Sarah Cannon Research Institute, Nashville and Tennessee Oncology, Chattanooga, TN, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Vicente', 'Affiliation': 'Department of Medical Oncology, Hospital Universitario Virgen Macarena, Seville, Spain.'}, {'ForeName': 'Shuji', 'Initials': 'S', 'LastName': 'Murakami', 'Affiliation': 'Department of Thoracic Oncology, Kanagawa Cancer Centre, Kanagawa, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Yokoi', 'Affiliation': 'Department of Thoracic Oncology, Kansai Medical University Hospital, Hirakata, Japan.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Chiappori', 'Affiliation': 'Thoracic Oncology Program, H Lee Moffitt Cancer Center and Research Institute, Tampa, FL, USA.'}, {'ForeName': 'Ki Hyeong', 'Initials': 'KH', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, College of Medicine, Chungbuk National University Hospital, Cheongju, Korea.'}, {'ForeName': 'Maike', 'Initials': 'M', 'LastName': 'de Wit', 'Affiliation': 'Department of Internal Medicine-Hematology, Oncology and Palliative Medicine, Vivantes Klinikum Neukölln, Berlin, Germany.'}, {'ForeName': 'Byoung Chul', 'Initials': 'BC', 'LastName': 'Cho', 'Affiliation': 'Department of Internal Medicine, Yonsei Cancer Centre, Yonsei University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Jhanelle E', 'Initials': 'JE', 'LastName': 'Gray', 'Affiliation': 'Thoracic Oncology Program, H Lee Moffitt Cancer Center and Research Institute, Tampa, FL, USA.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Rydén', 'Affiliation': 'AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Louis', 'Initials': 'L', 'LastName': 'Viviers', 'Affiliation': 'IQVIA, Saint-Ouen, France.'}, {'ForeName': 'Lynne', 'Initials': 'L', 'LastName': 'Poole', 'Affiliation': 'AstraZeneca, Cambridge, UK.'}, {'ForeName': 'Yiduo', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'AstraZeneca, Gaithersburg, MD, USA.'}, {'ForeName': 'Phillip A', 'Initials': 'PA', 'LastName': 'Dennis', 'Affiliation': 'AstraZeneca, Gaithersburg, MD, USA.'}, {'ForeName': 'Scott J', 'Initials': 'SJ', 'LastName': 'Antonia', 'Affiliation': 'Thoracic Oncology Program, H Lee Moffitt Cancer Center and Research Institute, Tampa, FL, USA.'}]",The Lancet. Oncology,['10.1016/S1470-2045(19)30519-4'] 1312,31554519,Effects of a multidisciplinary quality of life intervention on sleep quality in patients with advanced cancer receiving radiation therapy.,"OBJECTIVES Sleep disturbances are prevalent in cancer patients, especially those with advanced disease. There are few published intervention studies that address sleep issues in advanced cancer patients during the course of treatment. This study assesses the impact of a multidisciplinary quality of life (QOL) intervention on subjective sleep difficulties in patients with advanced cancer. METHOD This randomized trial investigated the comparative effects of a multidisciplinary QOL intervention (n = 54) vs. standard care (n = 63) on sleep quality in patients with advanced cancer receiving radiation therapy as a secondary endpoint. The intervention group attended six intervention sessions, while the standard care group received informational material only. Sleep quality was assessed using the Pittsburgh Sleep Quality Index (PSQI) and Epworth Sleepiness Scale (ESS), administered at baseline and weeks 4 (post-intervention), 27, and 52. RESULTS The intervention group had a statistically significant improvement in the PSQI total score and two components of sleep quality and daytime dysfunction than the control group at week 4. At week 27, although both groups showed improvements in sleep measures from baseline, there were no statistically significant differences between groups in any of the PSQI total and component scores, or ESS. At week 52, the intervention group used less sleep medication than control patients compared to baseline (p = 0.04) and had a lower ESS score (7.6 vs. 9.3, p = 0.03). SIGNIFICANCE OF RESULTS A multidisciplinary intervention to improve QOL can also improve sleep quality of advanced cancer patients undergoing radiation therapy. Those patients who completed the intervention also reported the use of less sleep medication.",2020,The intervention group had a statistically significant improvement in the PSQI total score and two components of sleep quality and daytime dysfunction than the control group at week 4.,"['advanced cancer patients undergoing radiation therapy', 'patients with advanced cancer', 'patients with advanced cancer receiving radiation therapy', 'patients with advanced cancer receiving radiation therapy as a secondary endpoint', 'cancer patients, especially those with advanced disease', 'advanced cancer patients']","['intervention group attended six intervention sessions, while the standard care group received informational material only', 'multidisciplinary quality of life intervention', 'multidisciplinary quality of life (QOL) intervention', 'multidisciplinary QOL intervention (n = 54) vs. standard care']","['sleep measures', 'Sleep quality', 'PSQI total and component scores, or ESS', 'lower ESS score', 'sleep quality', 'sleep medication', 'Pittsburgh Sleep Quality Index (PSQI) and Epworth Sleepiness Scale (ESS', 'PSQI total score', 'sleep quality and daytime dysfunction', 'subjective sleep difficulties']","[{'cui': 'C0877373', 'cui_str': 'Advanced cancer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0034619', 'cui_str': 'radiation therapy'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0520510', 'cui_str': 'Material (attribute)'}, {'cui': 'C0034380'}]","[{'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C3697468', 'cui_str': 'PSQI - Pittsburgh sleep quality index'}, {'cui': 'C3541276', 'cui_str': 'ESS - Epworth Sleepiness Scale'}, {'cui': 'C0332169', 'cui_str': 'Daytime (qualifier value)'}, {'cui': 'C0031847', 'cui_str': 'pathophysiology'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}]",,0.0294239,The intervention group had a statistically significant improvement in the PSQI total score and two components of sleep quality and daytime dysfunction than the control group at week 4.,"[{'ForeName': 'Melanie T', 'Initials': 'MT', 'LastName': 'Gentry', 'Affiliation': 'Department of Psychiatry and Psychology, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Pamela J', 'Initials': 'PJ', 'LastName': 'Atherton', 'Affiliation': 'Cancer Center Statistics Section, Division of Biomedical Statistics and Informatics, Department of Health Sciences, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Lapid', 'Affiliation': 'Department of Psychiatry and Psychology, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Preetha Sharone', 'Initials': 'PS', 'LastName': 'Rosen', 'Affiliation': 'Peace Health St John Medical Center, Longview, Washington, WA.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Kung', 'Affiliation': 'Department of Psychiatry and Psychology, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Jarrett', 'Initials': 'J', 'LastName': 'Richardson', 'Affiliation': 'Department of Psychiatry and Psychology, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Shehzad K', 'Initials': 'SK', 'LastName': 'Niazi', 'Affiliation': 'Department of Psychiatry and Psychology, Mayo Clinic, Jacksonville, FL.'}, {'ForeName': 'William V', 'Initials': 'WV', 'LastName': 'Bobo', 'Affiliation': 'Department of Psychiatry and Psychology, Mayo Clinic, Jacksonville, FL.'}, {'ForeName': 'Matthew M', 'Initials': 'MM', 'LastName': 'Clark', 'Affiliation': 'Department of Psychiatry and Psychology, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Teresa A', 'Initials': 'TA', 'LastName': 'Rummans', 'Affiliation': 'Department of Psychiatry and Psychology, Mayo Clinic, Rochester, MN.'}]",Palliative & supportive care,['10.1017/S1478951519000750'] 1313,31896379,The long-term indirect effect of the early Family Check-Up intervention on adolescent internalizing and externalizing symptoms via inhibitory control.,"This study examined the long-term effects of a randomized controlled trial of the Family Check-Up (FCU) intervention initiated at age 2 on inhibitory control in middle childhood and adolescent internalizing and externalizing problems. We hypothesized that the FCU would promote higher inhibitory control in middle childhood relative to the control group, which in turn would be associated with lower internalizing and externalizing symptomology at age 14. Participants were 731 families, with half (n = 367) of the families assigned to the FCU intervention. Using an intent-to-treat design, results indicate that the FCU intervention was indirectly associated with both lower internalizing and externalizing symptoms at age 14 via its effect on increased inhibitory control in middle childhood (i.e., ages 8.5-10.5). Findings highlight the potential for interventions initiated in toddlerhood to have long-term impacts on self-regulation processes, which can further reduce the risk for behavioral and emotional difficulties in adolescence.",2020,"Findings highlight the potential for interventions initiated in toddlerhood to have long-term impacts on self-regulation processes, which can further reduce the risk for behavioral and emotional difficulties in adolescence.","['Participants were 731 families, with half (n = 367) of the families assigned to the FCU intervention', 'middle childhood and adolescent internalizing and externalizing problems']","['FCU', 'FCU intervention', 'Family Check-Up (FCU) intervention', 'early Family Check-Up intervention']","['lower internalizing and externalizing symptoms', 'adolescent internalizing and externalizing symptoms']","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0444598', 'cui_str': 'Mid (qualifier value)'}, {'cui': 'C0231335', 'cui_str': 'Childhood (finding)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}]","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}]",731.0,0.022314,"Findings highlight the potential for interventions initiated in toddlerhood to have long-term impacts on self-regulation processes, which can further reduce the risk for behavioral and emotional difficulties in adolescence.","[{'ForeName': 'Rochelle F', 'Initials': 'RF', 'LastName': 'Hentges', 'Affiliation': 'Department of Psychology, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Chelsea M', 'Initials': 'CM', 'LastName': 'Weaver Krug', 'Affiliation': 'Department of Psychology, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Daniel S', 'Initials': 'DS', 'LastName': 'Shaw', 'Affiliation': 'Department of Psychology, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Melvin N', 'Initials': 'MN', 'LastName': 'Wilson', 'Affiliation': 'Department of Psychology, University of Virginia, Charlottesville, VA, USA.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Dishion', 'Affiliation': 'Department of Psychology, Arizona State University, Tempe, AZ, USA.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Lemery-Chalfant', 'Affiliation': 'Department of Psychology, Arizona State University, Tempe, AZ, USA.'}]",Development and psychopathology,['10.1017/S0954579419001482'] 1314,31582542,Lenalidomide-based induction and maintenance in elderly newly diagnosed multiple myeloma patients: updated results of the EMN01 randomized trial.,"n the EMN01 trial, the addition of an alkylator (melphalan or cyclophosphamide) to lenalidomide-steroid induction therapy was prospectively evaluated in transplant-ineligible patients with multiple myeloma. After induction, patients were randomly assigned to maintenance treatment with lenalidomide alone or with prednisone continuously. The analysis presented here (median follow-up of 71 months) is focused on maintenance treatment and on subgroup analyses defined according to the International Myeloma Working Group Frailty Score. Of the 654 evaluable patients, 217 were in the lenalidomide-dexamethasone arm, 217 in the melphalan-prednisone-lenalidomide arm and 220 in the cyclophosphamide-prednisone-lenalidomide arm. With regards to the Frailty Score, 284 (43%) patients were fit, 205 (31%) were intermediate-fit and 165 (25%) were frail. After induction, 402 patients were eligible for maintenance therapy (lenalidomide arm, n=204; lenalidomide-prednisone arm, n=198). After a median duration of maintenance of 22.0 months, progression-free survival from the start of maintenance was 22.2 months with lenalidomide-prednisone vs 18.6 months with lenalidomide (hazard ratio 0.85, P =0.14), with no differences across frailty subgroups. The most frequent grade ≥3 toxicity was neutropenia (10% of lenalidomide-prednisone and 21% of lenalidomide patients; P =0.001). Grade ≥3 non-hematologic adverse events were rare (<15%). In fit patients, melphalan-prednisone-lenalidomide significantly prolonged progression-free survival compared to cyclophosphamide-prednisone-lenalidomide (hazard ratio 0.72, P =0.05) and lenalidomide-dexamethasone (hazard ratio 0.72, P =0.04). Likewise, a trend towards a better overall survival was noted for patients treated with melphalan-prednisone-lenalidomide or cyclophosphamide-prednisone-lenalidomide, as compared to lenalidomide-dexamethasone. No differences were observed in intermediate-fit and frail patients. This analysis showed positive outcomes of maintenance with lenalidomide-based regimens, with a good safety profile. For the first time, we showed that fit patients benefit from a full-dose triplet regimen, while intermediate-fit and frail patients benefit from gentler regimens. ClinicalTrials.gov registration number: NCT01093196.",2020,Grade ≥3 non-hematologic adverse events were rare (<15%).,"['transplant-ineligible multiple myeloma patients', 'elderly newly diagnosed multiple myeloma patients', '217 patients in', '284', '402 patients were eligible for maintenance, (lenalidomide arm: 204']","['cyclophosphamide-prednisone-lenalidomide (HR 0.72,p=0.05) and lenalidomide-dexamethasone', 'lenalidomide-dexamethasone', 'Lenalidomide-based induction and maintenance', 'lenalidomide-prednisone', 'lenalidomide-dexamethasone, 217 in melphalan-prednisone-lenalidomide and 220 in cyclophosphamide-prednisone-lenalidomide', 'lenalidomide alone or with prednisone continuously', 'alkylator (melphalan or cyclophosphamide', 'melphalan-prednisone-lenalidomide', 'melphalan-prednisone-lenalidomide and cyclophosphamide-prednisone-lenalidomide']","['progression-free survival', 'prolonged progression-free survival', 'Grade ≥3 non-hematologic adverse events', 'overall survival', 'neutropenia']","[{'cui': 'C0332835', 'cui_str': 'Grafts'}, {'cui': 'C0026764', 'cui_str': 'Myelomatosis'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517646', 'cui_str': '217'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C1144149', 'cui_str': 'lenalidomide'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}]","[{'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C1144149', 'cui_str': 'lenalidomide'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C4517646', 'cui_str': '217'}, {'cui': 'C0025241', 'cui_str': 'Melphalan'}, {'cui': 'C4517650', 'cui_str': '220 (qualifier value)'}, {'cui': 'C0002073', 'cui_str': 'Alkylators'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0439590', 'cui_str': 'Prolonged (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0205488', 'cui_str': 'Hematologic (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}]",402.0,0.100541,Grade ≥3 non-hematologic adverse events were rare (<15%).,"[{'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Bringhen', 'Affiliation': 'Myeloma Unit, Division of Hematology, University of Torino, Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino, Torino, Italy sarabringhen@yahoo.com.'}, {'ForeName': 'Mattia', 'Initials': 'M', 'LastName': ""D'Agostino"", 'Affiliation': 'Myeloma Unit, Division of Hematology, University of Torino, Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino, Torino, Italy.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Paris', 'Affiliation': 'Hematology and Bone Marrow Transplant Unit, Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII, Bergamo, Italy.'}, {'ForeName': 'Stelvio', 'Initials': 'S', 'LastName': 'Ballanti', 'Affiliation': ""Sezione di Ematologia e Immunologia Clinica, Ospedale Santa Maria della Misericordia, località Sant'Andrea delle Fratte, Perugia, Italy.""}, {'ForeName': 'Norbert', 'Initials': 'N', 'LastName': 'Pescosta', 'Affiliation': 'Reparto Ematologia e Centro TMO, Ospedale Centrale, Bolzano, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Spada', 'Affiliation': 'Myeloma Unit, Division of Hematology, University of Torino, Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino, Torino, Italy.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Pezzatti', 'Affiliation': 'Divisione di Ematologia, Ospedale S. Gerardo, Monza, Italy.'}, {'ForeName': 'Mariella', 'Initials': 'M', 'LastName': 'Grasso', 'Affiliation': 'Azienda Ospedaliera S. Croce-Carle, Cuneo, Italy.'}, {'ForeName': 'Delia', 'Initials': 'D', 'LastName': 'Rota-Scalabrini', 'Affiliation': 'Medical Oncology, Candiolo Cancer Institute FPO-IRCCS, Candiolo, Italy.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'De Rosa', 'Affiliation': 'Hematology and Stem Cell Transplantation Unit, Az. Osp. S. Camillo-Forlanini, Rome, Italy.'}, {'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'Pavone', 'Affiliation': 'UOC Ematologia e Trapianto, Az. Osp. C. Panico, Tricase (Lecce), Italy.'}, {'ForeName': 'Giulia', 'Initials': 'G', 'LastName': 'Gazzera', 'Affiliation': 'Myeloma Unit, Division of Hematology, University of Torino, Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino, Torino, Italy.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Aquino', 'Affiliation': 'Ematologia e Centro Trapianti, IRCCS Ospedale Policlinico San Martino, Genova, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Poggiu', 'Affiliation': 'Myeloma Unit, Division of Hematology, University of Torino, Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino, Torino, Italy.'}, {'ForeName': 'Armando', 'Initials': 'A', 'LastName': 'Santoro', 'Affiliation': 'Istituto Clinico Humanitas, Humanitas University, Rozzano-Milano, Italy.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Gentile', 'Affiliation': 'UOC Ematologia AO Cosenza, Cosenza, Italy.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Baldini', 'Affiliation': 'UOC Ematologia, Università degli Studi di Milano, Fondazione IRCCS Cà Granda, Ospedale Maggiore Policlinico, Milano, Italy.'}, {'ForeName': 'Maria Teresa', 'Initials': 'MT', 'LastName': 'Petrucci', 'Affiliation': 'Hematology, Azienda Policlinico Umberto I, Roma, Italy.'}, {'ForeName': 'Patrizia', 'Initials': 'P', 'LastName': 'Tosi', 'Affiliation': 'UO Ematologia, Ospedale di Rimini, AUSL della Romagna, Rimini, Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Marasca', 'Affiliation': 'Hematology Unit, Department of Medical and Surgical Sciences, University of Modena and Reggio Emilia, Modena, Italy.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Cellini', 'Affiliation': 'U.O. Ematologia, Ospedale Santa Maria delle Croci, Ravenna, Italy.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Palumbo', 'Affiliation': 'Myeloma Unit, Division of Hematology, University of Torino, Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino, Torino, Italy.'}, {'ForeName': 'Patrizia', 'Initials': 'P', 'LastName': 'Falco', 'Affiliation': 'SSD Ematologia, ASLTO4, Ospedali di Chivasso Cirié Ivrea, Italy.'}, {'ForeName': 'Roman', 'Initials': 'R', 'LastName': 'Hájek', 'Affiliation': 'Department of Hematooncology, University Hospital Ostrava, Ostrava, Czech Republic.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Boccadoro', 'Affiliation': 'Myeloma Unit, Division of Hematology, University of Torino, Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino, Torino, Italy.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Larocca', 'Affiliation': 'Myeloma Unit, Division of Hematology, University of Torino, Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino, Torino, Italy.'}]",Haematologica,['10.3324/haematol.2019.226407'] 1315,31584525,Successful Treatment of Multiple Common Warts With Intralesional Ozone.,"BACKGROUND Although there are multiple treatments for warts, wart management remains a challenge. Ozone therapy is an emerging treatment for infectious and noninfectious dermatological diseases. OBJECTIVE To assess intralesional ozone gas safety and efficacy in multiple warts management. MATERIALS AND METHODS Seventy-four adult patients with multiple common warts were included in this study. They were randomly assigned into 2 groups: first group comprised 44 patients treated with intralesional ozone gas, and the second group comprised 30 patients who received intralesional saline injection. In both groups, warts in all patients were directly injected weekly until complete clearance occurred or for a maximum of 10 treatment sessions. The subjects were followed for 6 months to record any recurrences. RESULTS In the ozone group, 25 patients (56.8%) had a complete response with an excellent cosmetic outcome, 15 patients (34.1%) showed a partial response, and 4 patients (9.1%) had no response. More subjects responded to ozone than to saline (p < .001). Ozone therapy was associated with mild side effects, including pain at time of injection, numbness, and fatigue. CONCLUSION Intralesional ozone is effective and safe for the treatment of multiple warts.",2020,More subjects responded to ozone than to saline (p < .001).,['Seventy-four adult patients with multiple common warts were included in this study'],"['intralesional ozone gas', 'Intralesional Ozone', 'intralesional saline injection', 'Ozone therapy']","['complete response with an excellent cosmetic outcome', 'mild side effects, including pain at time of injection, numbness, and fatigue', 'partial response']","[{'cui': 'C4517867', 'cui_str': 'Seventy-four'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0043037', 'cui_str': 'Verruca vulgaris (disorder)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0030106', 'cui_str': 'Ozone'}, {'cui': 'C0596601', 'cui_str': 'Gas'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C1961136', 'cui_str': 'Excellent (qualifier value)'}, {'cui': 'C0442965', 'cui_str': 'Cosmetic procedure (qualifier value)'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0020580', 'cui_str': 'Reduced Sensation'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}]",74.0,0.0479414,More subjects responded to ozone than to saline (p < .001).,"[{'ForeName': 'Alshimaa M', 'Initials': 'AM', 'LastName': 'Ibrahim', 'Affiliation': '*All authors are affiliated with the Dermatology, Venereology and Andrology Department, Faculty of Medicine, Zagazig University, Zagazig, Egypt.'}, {'ForeName': 'Reham A', 'Initials': 'RA', 'LastName': 'Elkot', 'Affiliation': ''}, {'ForeName': 'Shrook A', 'Initials': 'SA', 'LastName': 'Khashaba', 'Affiliation': 'All authors are affiliated with the Dermatology, Venereology and Andrology Department, Faculty of Medicine, Zagazig University, Zagazig, Egypt.'}]",Dermatologic surgery : official publication for American Society for Dermatologic Surgery [et al.],['10.1097/DSS.0000000000002174'] 1316,31714033,"Motivated, Fit, and Strong-Using Counter-Stereotypical Images to Reduce Weight Stigma Internalisation in Women with Obesity.","BACKGROUND This study aimed to use implicit retraining to change automatic associations between body size and physical activity (PA) in women with obesity to reduce weight bias internalisation (WBI). METHODS A Solomon-square experimental design was used to determine the effect of a four-week online implicit retraining intervention on WBI (primary measure) and PA attitudes, self-efficacy, and self-reported behaviour (secondary measures). The intervention was a visual probe task pairing counter-stereotypical images of active individuals with obesity with positive PA-related words. In qualitative telephone interviews, a sub-sample of participants provided feedback and recommendations for using counter-stereotypical images in PA promotion. RESULTS Women completed the intervention (n = 48) or a control task (n = 55). Results of a RM-ANOVA showed no interaction or main effect of group on WBI. A main effect of time demonstrated that both groups had reduced WBI between pre-test and post-test, through to one-week follow-up. There were no differences between groups or over time for PA attitudes, self-efficacy, or behaviour. Women who completed interviews (n = 16) discussed several benefits and drawbacks of using counter-stereotypical images. CONCLUSION Implicit retraining did not reduce WBI but qualitative findings support the use of counter-stereotypical PA images.",2019,"A main effect of time demonstrated that both groups had reduced WBI between pre-test and post-test, through to one-week follow-up.","['active individuals with obesity with positive PA-related words', 'women with obesity to reduce weight bias internalisation (WBI', 'Women with Obesity']","['Implicit retraining', 'online implicit retraining intervention', 'implicit retraining']","['time for PA attitudes, self-efficacy, or behaviour', 'WBI (primary measure) and PA attitudes, self-efficacy, and self-reported behaviour (secondary measures']","[{'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0005346', 'cui_str': 'Bias'}]",[],"[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}]",,0.0307913,"A main effect of time demonstrated that both groups had reduced WBI between pre-test and post-test, through to one-week follow-up.","[{'ForeName': 'Maxine', 'Initials': 'M', 'LastName': 'Myre', 'Affiliation': 'University of Alberta, Alberta, Canada.'}, {'ForeName': 'Tanya R', 'Initials': 'TR', 'LastName': 'Berry', 'Affiliation': 'University of Alberta, Alberta, Canada.'}, {'ForeName': 'Geoff D C', 'Initials': 'GDC', 'LastName': 'Ball', 'Affiliation': 'University of Alberta, Alberta, Canada.'}, {'ForeName': 'Brad', 'Initials': 'B', 'LastName': 'Hussey', 'Affiliation': 'Obesity Canada, Edmonton, Canada.'}]",Applied psychology. Health and well-being,['10.1111/aphw.12187'] 1317,31575509,"Pamrevlumab, an anti-connective tissue growth factor therapy, for idiopathic pulmonary fibrosis (PRAISE): a phase 2, randomised, double-blind, placebo-controlled trial.","BACKGROUND Connective tissue growth factor (CTGF) is a secreted glycoprotein that has a central role in the process of fibrosis. This study was designed to assess the safety, tolerability, and efficacy of pamrevlumab (FG-3019), a fully recombinant human monoclonal antibody against CTGF, in idiopathic pulmonary fibrosis. The aim was to establish whether pamrevlumab could slow, stop, or reverse progression of idiopathic pulmonary fibrosis. METHODS The phase 2, randomised, double-blind, placebo-controlled PRAISE trial was done at 39 medical centres in seven countries (Australia, Bulgaria, Canada, India, New Zealand, South Africa, and the USA). Patients with idiopathic pulmonary fibrosis and percentage of predicted forced vital capacity (FVC) of 55% or greater were enrolled and randomly assigned (1:1) by use of interactive responsive technology to intravenous infusion of pamrevlumab 30 mg/kg or placebo every 3 weeks over 48 weeks (16 infusions). The primary efficacy outcome was change from baseline in percentage of predicted FVC at week 48. Disease progression (defined as a decline from baseline in percentage of predicted FVC of ≥10%, or death) at week 48 was a key secondary efficacy outcome. All patients in the pamrevlumab group received at least one dose of the study drug and were analysed for safety. Two patients in the placebo group were excluded from the intention-to-treat population for the efficacy analyses because of enrolment error. This trial is registered with ClinicalTrials.gov, NCT01890265. FINDINGS Between Aug 17, 2013, and July 21, 2017, 103 patients were randomly assigned (50 to pamrevlumab and 53 to placebo). Pamrevlumab reduced the decline in percentage of predicted FVC by 60·3% at week 48 (mean change from baseline -2·9% with pamrevlumab vs -7·2% with placebo; between-group difference 4·3% [95% CI 0·4-8·3]; p=0·033). The proportion of patients with disease progression was lower in the pamrevlumab group than in the placebo group at week 48 (10·0% vs 31·4%; p=0·013). Pamrevlumab was well tolerated, with a safety profile similar to that of placebo. Treatment-emergent serious adverse events were observed in 12 (24%) patients in the pamrevlumab group and eight (15%) in the placebo group, with three patients on pamrevlumab and seven on placebo discontinuing treatment. Of the three (6%) deaths in the pamrevlumab group and six (11%) in the placebo group, none was considered treatment related. INTERPRETATION Pamrevlumab attenuated progression of idiopathic pulmonary fibrosis and was well tolerated. Now in phase 3 development, pamrevlumab shows promise as a novel, safe, and effective treatment for idiopathic pulmonary fibrosis. FUNDING FibroGen.",2020,The proportion of patients with disease progression was lower in the pamrevlumab group than in the placebo group at week 48 (10·0% vs 31·4%; p=0·013).,"['Patients with idiopathic pulmonary fibrosis and percentage of predicted forced vital capacity (FVC) of 55% or greater were enrolled and randomly assigned (1:1) by use of', 'idiopathic pulmonary fibrosis', 'idiopathic pulmonary fibrosis (PRAISE', '39 medical centres in seven countries (Australia, Bulgaria, Canada, India, New Zealand, South Africa, and the USA', 'Between Aug 17, 2013, and July 21, 2017, 103 patients']","['Pamrevlumab, an anti-connective tissue growth factor therapy', 'placebo', 'Connective tissue growth factor (CTGF', 'interactive responsive technology to intravenous infusion of pamrevlumab 30 mg/kg or placebo', 'recombinant human monoclonal antibody against CTGF', 'pamrevlumab and 53 to placebo', 'pamrevlumab (FG-3019']","['proportion of patients with disease progression', 'Disease progression', 'safety, tolerability, and efficacy', 'Treatment-emergent serious adverse events', 'percentage of predicted FVC']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0085786', 'cui_str': 'Alveolitis, Fibrosing'}, {'cui': 'C2919678', 'cui_str': 'Percentage of predicted forced vital capacity (observable entity)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0557963', 'cui_str': 'Praising (procedure)'}, {'cui': 'C0565990', 'cui_str': 'Medical center (environment)'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0006368', 'cui_str': 'Bulgaria'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0021201', 'cui_str': 'Republic of India'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C0037712', 'cui_str': 'Union of South Africa'}, {'cui': 'C4517526', 'cui_str': 'One hundred and three'}]","[{'cui': 'C0110610', 'cui_str': 'IGF-Binding Protein-Related Protein-2'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0205342', 'cui_str': 'Responsive (qualifier value)'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0021440', 'cui_str': 'Infusions, Intravenous'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C3542957', 'cui_str': 'Antineoplastic MAbs'}, {'cui': 'C2985186', 'cui_str': 'FG 3019'}]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0242656', 'cui_str': 'Disease Progression'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",103.0,0.649002,The proportion of patients with disease progression was lower in the pamrevlumab group than in the placebo group at week 48 (10·0% vs 31·4%; p=0·013).,"[{'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Richeldi', 'Affiliation': 'Fondazione Policlinico Universitario A. Gemelli IRCCS, Università Cattolica del Sacro Cuore, Rome, Italy. Electronic address: luca.richeldi@policlinicogemelli.it.'}, {'ForeName': 'Evans R', 'Initials': 'ER', 'LastName': 'Fernández Pérez', 'Affiliation': 'National Jewish Health, Denver, CO, USA.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Costabel', 'Affiliation': 'Ruhrlandklinik, University Hospital, Essen, Germany.'}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Albera', 'Affiliation': 'University of Torino, Italy.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Lederer', 'Affiliation': 'Columbia University Medical Center, New York, NY, USA.'}, {'ForeName': 'Kevin R', 'Initials': 'KR', 'LastName': 'Flaherty', 'Affiliation': 'University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Ettinger', 'Affiliation': ""St Luke's Hospital, Chesterfield, MO, USA.""}, {'ForeName': 'Rafael', 'Initials': 'R', 'LastName': 'Perez', 'Affiliation': 'University of Louisville, Louisville, KY, USA.'}, {'ForeName': 'Mary Beth', 'Initials': 'MB', 'LastName': 'Scholand', 'Affiliation': 'University of Utah, Lung Health Research, Salt Lake City, UT, USA.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Goldin', 'Affiliation': 'MedQIA, Los Angeles, CA, USA.'}, {'ForeName': 'Kin-Hung', 'Initials': 'KH', 'LastName': 'Peony Yu', 'Affiliation': 'FibroGen, San Francisco, CA, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Neff', 'Affiliation': 'FibroGen, San Francisco, CA, USA.'}, {'ForeName': 'Seth', 'Initials': 'S', 'LastName': 'Porter', 'Affiliation': 'FibroGen, San Francisco, CA, USA.'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Zhong', 'Affiliation': 'FibroGen, San Francisco, CA, USA.'}, {'ForeName': 'Eduard', 'Initials': 'E', 'LastName': 'Gorina', 'Affiliation': 'FibroGen, San Francisco, CA, USA.'}, {'ForeName': 'Elias', 'Initials': 'E', 'LastName': 'Kouchakji', 'Affiliation': 'FibroGen, San Francisco, CA, USA.'}, {'ForeName': 'Ganesh', 'Initials': 'G', 'LastName': 'Raghu', 'Affiliation': 'University of Washington Medical Center, Seattle, WA, USA.'}]",The Lancet. Respiratory medicine,['10.1016/S2213-2600(19)30262-0'] 1318,31509204,Effect of a Standard vs Enhanced Implementation Strategy to Improve Antibiotic Prescribing in Nursing Homes: A Trial Protocol of the Improving Management of Urinary Tract Infections in Nursing Institutions Through Facilitated Implementation (IMUNIFI) Study.,"Importance Suspicion of urinary tract infection (UTI) is the major driver of overuse and misuse of antibiotics in nursing homes (NHs). Effects of interventions to improve the recognition and management of UTI in NHs have been mixed, potentially owing to differences in how interventions were implemented in different studies. An improved understanding of how implementation approach influences intervention adoption is needed to achieve wider dissemination of antibiotic stewardship interventions in NHs. Objective To compare the effects of 2 implementation strategies on the adoption and effects of a quality improvement toolkit to enhance recognition and management of UTIs in NHs. Design, Setting, and Participants This cluster-randomized hybrid type 2 effectiveness-implementation clinical trial will be performed over a 6-month baseline (January to June 2019) and 12-month postimplementation period (July 2019 to June 2020). A minimum of 20 Wisconsin NHs with 50 or more beds will be recruited and randomized in block sizes of 2 stratified by rurality (rural vs urban). All residents who are tested and/or treated for UTI in study NHs will be included in the analysis. All study NHs will implement a quality improvement toolkit focused on enhancing the recognition and management of UTIs. Facilities will be randomized to either a usual or enhanced implementation approach based on external facilitation (coaching), collaborative peer learning, and peer comparison feedback. Enhanced implementation is hypothesized to be associated with improvements in adoption of the quality improvement toolkit and clinical outcomes. Primary outcomes of the study will include number of (1) urine cultures per 1000 resident days and (2) antibiotic prescriptions for treatment of suspected UTI per 1000 resident-days. Secondary outcomes of the study will include appropriateness of UTI treatments, treatment length, use of fluoroquinolones, and resident transfers and mortality. A mixed-methods evaluation approach will be used to assess extent and determinants of adoption of the UTI quality improvement toolkit in study NHs. Discussion Knowledge gained during this study could help inform future efforts to implement antibiotic stewardship and quality improvement interventions in NHs. Trial Registration ClinicalTrials.gov identifier: NCT03520010.",2019,"Facilities will be randomized to either a usual or enhanced implementation approach based on external facilitation (coaching), collaborative peer learning, and peer comparison feedback.","['Nursing Homes', 'UTIs in NHs', '20 Wisconsin NHs with 50 or more beds will be recruited and randomized in block sizes of 2 stratified by rurality (rural vs urban', 'All residents who are tested and/or treated for UTI in study NHs will be included in the analysis']","['usual or enhanced implementation approach based on external facilitation (coaching), collaborative peer learning, and peer comparison feedback']","['Antibiotic', 'appropriateness of UTI treatments, treatment length, use of fluoroquinolones, and resident transfers and mortality', 'number of (1) urine cultures per 1000 resident days and (2) antibiotic prescriptions']","[{'cui': 'C0028688', 'cui_str': 'Nursing Homes'}, {'cui': 'C0043193', 'cui_str': 'Wisconsin'}, {'cui': 'C0004916', 'cui_str': 'Beds'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0205363', 'cui_str': 'Stratified (qualifier value)'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for (contextual qualifier) (qualifier value)'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease (disorder)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}]","[{'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0205101', 'cui_str': 'External (qualifier value)'}, {'cui': 'C0234112', 'cui_str': 'Facilitation, function (observable entity)'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}]","[{'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease (disorder)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0949665', 'cui_str': 'Fluoroquinolones'}, {'cui': 'C0040671', 'cui_str': 'Transfer'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0430404', 'cui_str': 'Urine culture (procedure)'}, {'cui': 'C1883310', 'cui_str': '1000 (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0033080', 'cui_str': 'Prescriptions'}]",,0.108839,"Facilities will be randomized to either a usual or enhanced implementation approach based on external facilitation (coaching), collaborative peer learning, and peer comparison feedback.","[{'ForeName': 'James H', 'Initials': 'JH', 'LastName': 'Ford', 'Affiliation': 'School of Pharmacy, University of Wisconsin, Madison.'}, {'ForeName': 'Lillian', 'Initials': 'L', 'LastName': 'Vranas', 'Affiliation': 'School of Medicine and Public Health, University of Wisconsin, Madison.'}, {'ForeName': 'DaRae', 'Initials': 'D', 'LastName': 'Coughlin', 'Affiliation': 'Center for Health Systems Research and Analysis, University of Wisconsin, Madison.'}, {'ForeName': 'Kathi M', 'Initials': 'KM', 'LastName': 'Selle', 'Affiliation': 'School of Medicine and Public Health, University of Wisconsin, Madison.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Nordman-Oliveira', 'Affiliation': 'Center for Health Systems Research and Analysis, University of Wisconsin, Madison.'}, {'ForeName': 'Brenda', 'Initials': 'B', 'LastName': 'Ryther', 'Affiliation': 'Center for Health Systems Research and Analysis, University of Wisconsin, Madison.'}, {'ForeName': 'Tola', 'Initials': 'T', 'LastName': 'Ewers', 'Affiliation': 'School of Medicine and Public Health, University of Wisconsin, Madison.'}, {'ForeName': 'Victoria L', 'Initials': 'VL', 'LastName': 'Griffin', 'Affiliation': 'Wisconsin Department of Health Services, Division of Quality Assurance, Bureau of Education Services & Technology, Madison.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Eslinger', 'Affiliation': 'Marshfield Medical Center, Eau Claire, Wisconsin.'}, {'ForeName': 'Joe', 'Initials': 'J', 'LastName': 'Boero', 'Affiliation': 'Wisconsin Healthcare-Associated Infections in Long-Term Care Coalition, Madison.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Hardgrove', 'Affiliation': 'Aurora Health Care, West Allis, Wisconsin.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Crnich', 'Affiliation': 'School of Medicine and Public Health, University of Wisconsin, Madison.'}]",JAMA network open,['10.1001/jamanetworkopen.2019.9526'] 1319,31862147,"Use of professional-mode flash glucose monitoring, at 3-month intervals, in adults with type 2 diabetes in general practice (GP-OSMOTIC): a pragmatic, open-label, 12-month, randomised controlled trial.","BACKGROUND Continuous glucose monitoring, either real-time (personal) or retrospective (professional mode), can identify day-to-day glucose profiles to guide management decisions for people with type 2 diabetes. We aimed to examine the effects of professional-mode flash glucose monitoring, done at 3-month intervals, in adults with type 2 diabetes in general practice. METHODS We did a pragmatic, two-arm, open label, 12-month, individually randomised controlled trial (GP-OSMOTIC) in 25 general practices in Victoria, Australia. Eligible participants were adults aged 18-80 years, with type 2 diabetes diagnosed for at least 1 year and HbA 1c at least 5·5 mmol/mol (0·5%) above their target in the past month despite being prescribed at least two non-insulin glucose-lowering drugs, insulin, or both (with therapy stable for at least 4 months). We randomly assigned participants (1:1) to either use of a professional-mode flash glucose monitoring system or usual clinical care (control). All participants wore the flash glucose monitoring sensor at baseline, and electronic randomisation (using permuted block sizes of four and six, and stratified by clinic) was done after the sensor was attached. Masking of participants and treating clinicians to group allocation was not possible, but the study statistician was masked to allocation when analysing the data. At baseline, and 3, 6, 9, and 12 months, participants in the flash glucose monitoring group wore the professional-mode flash glucose monitoring sensor for 5-14 days before their general practice visit. The sensor recorded interstitial glucose concentrations every 15 min, but the glucose data were not available to the participant until their general practice visit, where the sensor output would be uploaded to a computer by the health professional and discussed. Control group participants wore the sensor at baseline and at 12 months for data analysis only, and had usual care visits every 3 months. The primary outcome was the between-group difference in mean HbA 1c at 12 months. Secondary outcomes were the between-group differences in: mean percentage time in target glucose range (4-10 mmol/L), based on ambulatory glucose profile data at 12 months; mean diabetes-specific distress (assessed with the Problem Areas In Diabetes [PAID] scale) at 12 months; and mean HbA 1c at 6 months. Analysis was done by intention to treat. This trial is registered at the Australian and New Zealand Clinical Trials Registry, ACTRN12616001372471. FINDINGS Between Oct 4, 2016, and Nov 17, 2017, we randomly assigned 299 adults: 149 to flash glucose monitoring and 150 to usual care. At 6 months, HbA 1c was lower in the flash glucose monitoring group than in the usual care group (difference -0·5%, 95% CI -0·8% to -0·3%; p=0·0001). However, at 12 months (primary outcome), there was no significant between-group difference in estimated mean HbA 1c (8·2% [95% CI 8·0 to 8·4] for flash glucose monitoring vs 8·5% [8·3 to 8·7] for usual care; between-group difference -0·3%, 95% CI -0·5 to 0·01; [66 mmol/mol, 95% CI 64 to 68 vs 69 mmol/mol, 67 to 72; between-group difference -3·0, 95% CI -5·0 to 0·1]; p=0·059). Mean percentage time spent in target glucose range at 12 months was 7·9% (95% CI 2·3 to 13·5) higher in the flash glucose monitoring group than in the usual care group (p=0·0060). Diabetes-specific distress PAID scores were unchanged at 12 months (between-group difference -0·7, 95% CI -3·3 to 1·9; p=0·61). No episodes of severe hypoglycaemia or treatment-related deaths were reported. One participant died during the study from causes unrelated to the intervention (following complications post-myocardial infarction with multiple comorbidities). INTERPRETATION Professional-mode flash glucose monitoring in adults with type 2 diabetes in general practice did not improve the primary outcome of HbA 1c at 12 months or diabetes-specific distress compared with usual care, but did improve time in target glucose range at 12 months and HbA 1c at 6 months. Our findings suggest that professional-mode flash glucose monitoring can be implemented in a pragmatic primary care environment. Although there was no change in HbA 1c at 12 months, the improved time in target range might reflect the potential of the technology to support personalised clinical care by providing insights into glycaemic profiles for some people with type 2 diabetes. FUNDING National Health and Medical Research Council of Australia, Sanofi Australia, and Abbott Diabetes Care.",2020,Diabetes-specific distress PAID scores were unchanged at 12 months (between-group difference,"['adults with type 2 diabetes in general practice (GP-OSMOTIC', 'adults with type 2 diabetes in general practice', '25 general practices in Victoria, Australia', 'Eligible participants were adults aged 18-80 years, with type 2 diabetes diagnosed for at least 1 year and HbA 1c at least 5·5 mmol/mol (0·5%) above their target in the past month despite being prescribed at least two non-insulin glucose-lowering drugs, insulin, or both (with therapy stable for at least 4 months', 'people with type 2 diabetes']","['professional-mode flash glucose monitoring', 'flash glucose monitoring and 150 to usual care', 'professional-mode flash glucose monitoring system or usual clinical care (control', 'flash glucose monitoring group wore the professional-mode flash glucose monitoring sensor']","['estimated mean HbA 1c', 'severe hypoglycaemia or treatment-related deaths', 'mean percentage time in target glucose range (4-10 mmol/L), based on ambulatory glucose profile data at 12 months; mean diabetes-specific distress', 'HbA 1c', 'flash glucose monitoring', 'Diabetes-specific distress PAID scores', 'time in target glucose range', 'flash glucose monitoring sensor', 'Mean percentage time spent in target glucose range']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0086343', 'cui_str': 'General Practice'}, {'cui': 'C0042645', 'cui_str': 'Victoria'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C0439189', 'cui_str': 'mole - unit'}, {'cui': 'C1444637', 'cui_str': 'In the past'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}]","[{'cui': 'C0344323', 'cui_str': 'Flashing (disorder)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C3873850', 'cui_str': 'Glucose monitoring system'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C1532563', 'cui_str': 'umol/mL'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0439841', 'cui_str': 'Ambulatory'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0344323', 'cui_str': 'Flashing (disorder)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",299.0,0.103683,Diabetes-specific distress PAID scores were unchanged at 12 months (between-group difference,"[{'ForeName': 'John', 'Initials': 'J', 'LastName': 'Furler', 'Affiliation': 'Department of General Practice, University of Melbourne, Parkville, VIC, Australia. Electronic address: j.furler@unimelb.edu.au.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': ""O'Neal"", 'Affiliation': 'Department of Medicine, University of Melbourne, Parkville, VIC, Australia.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Speight', 'Affiliation': 'School of Psychology, Deakin University, Geelong, VIC, Australia; Australian Centre for Behavioural Research in Diabetes, Diabetes Victoria, Melbourne, VIC, Australia.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Blackberry', 'Affiliation': 'John Richards Centre for Rural Ageing Research, La Trobe Rural Health School, La Trobe University, Wodonga, VIC, Australia.'}, {'ForeName': 'Jo-Anne', 'Initials': 'JA', 'LastName': 'Manski-Nankervis', 'Affiliation': 'Department of General Practice, University of Melbourne, Parkville, VIC, Australia.'}, {'ForeName': 'Sharmala', 'Initials': 'S', 'LastName': 'Thuraisingam', 'Affiliation': 'Department of General Practice, University of Melbourne, Parkville, VIC, Australia.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'de La Rue', 'Affiliation': 'Department of General Practice, University of Melbourne, Parkville, VIC, Australia.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Ginnivan', 'Affiliation': 'Department of General Practice, University of Melbourne, Parkville, VIC, Australia.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Doyle', 'Affiliation': 'Department of General Practice, University of Melbourne, Parkville, VIC, Australia.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Holmes-Truscott', 'Affiliation': 'School of Psychology, Deakin University, Geelong, VIC, Australia; Australian Centre for Behavioural Research in Diabetes, Diabetes Victoria, Melbourne, VIC, Australia.'}, {'ForeName': 'Kamlesh', 'Initials': 'K', 'LastName': 'Khunti', 'Affiliation': 'Diabetes Research Centre, University of Leicester, Leicester General Hospital, Leicester, UK.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Dalziel', 'Affiliation': 'School of Global and Population Health, University of Melbourne, Parkville, VIC, Australia.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Chiang', 'Affiliation': 'Department of General Practice, University of Melbourne, Parkville, VIC, Australia.'}, {'ForeName': 'Ralph', 'Initials': 'R', 'LastName': 'Audehm', 'Affiliation': 'Department of General Practice, University of Melbourne, Parkville, VIC, Australia.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Kennedy', 'Affiliation': 'Department of General Practice, University of Melbourne, Parkville, VIC, Australia.'}, {'ForeName': 'Malcolm', 'Initials': 'M', 'LastName': 'Clark', 'Affiliation': 'Department of General Practice, University of Melbourne, Parkville, VIC, Australia.'}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Jenkins', 'Affiliation': 'National Health and Medical Research Council of Australia Clinical Trials Centre, University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Amelia J', 'Initials': 'AJ', 'LastName': 'Lake', 'Affiliation': 'School of Psychology, Deakin University, Geelong, VIC, Australia; Australian Centre for Behavioural Research in Diabetes, Diabetes Victoria, Melbourne, VIC, Australia.'}, {'ForeName': 'Andrzej S', 'Initials': 'AS', 'LastName': 'Januszewski', 'Affiliation': 'National Health and Medical Research Council of Australia Clinical Trials Centre, University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Max', 'Initials': 'M', 'LastName': 'Catchpool', 'Affiliation': 'School of Global and Population Health, University of Melbourne, Parkville, VIC, Australia.'}, {'ForeName': 'Danny', 'Initials': 'D', 'LastName': 'Liew', 'Affiliation': 'Centre of Cardiovascular Research and Education in Therapeutics, Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Clarke', 'Affiliation': 'School of Global and Population Health, University of Melbourne, Parkville, VIC, Australia.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Best', 'Affiliation': 'Lee Kong Chian School of Medicine, Nanyang Technological University, Singapore; Imperial College London, London, UK.'}]",The lancet. Diabetes & endocrinology,['10.1016/S2213-8587(19)30385-7'] 1320,32413530,Cranberry capsules are not superior to placebo capsules in managing acute non-haemorrhagic radiation cystitis in prostate cancer patients: A phase III double blinded randomised placebo controlled clinical trial.,"PURPOSE Acute radiation cystitis affects the quality of life of many prostate cancer patients. A previous pilot study suggested that cranberry capsules may decrease some of the symptoms of acute radiation cystitis. Here we further test their effectiveness in a multicentre double blinded placebo-controlled clinical trial. MATERIAL AND METHODS A total of 108 prostate cancer patients were recruited at three New Zealand hospitals between September 2016 and January 2019. Out of this cohort, 101 patients provided datasets for analysis (51 men on cranberry capsules and 50 men on beetroot-containing placebo capsules). Patients took two capsules each morning during RT and for 2 weeks after completion of RT. Three measures were used to assess cystitis severity: modified RTOG, O'Leary interstitial cystitis scale and a sensitive novel radiation induced cystitis assessment scale (RICAS). Cystitis severity was scored at baseline and weekly thereafter during RT and for two weeks after completion of RT. Radiation protocols were stratified to conventional fractionation or hypo-fractionated radiation therapy (CHHiP) to the prostate or radiation to the prostate bed. RESULTS Cranberry capsules performed significantly worse than placebo capsules with respect to day time frequency and bladder control, using the more sensitive RICAS scale. No significant difference in cystitis severity was seen between patients receiving hypofractionation and those receiving conventional fractionation to the prostate gland. CONCLUSION Cranberry capsules were not superior to beetroot-containing placebo capsules in managing radiation cystitis in our prostate patient cohort. RICAS may be a useful tool for measuring radiation cystitis in future studies.",2020,"No significant difference in cystitis severity was seen between patients receiving hypofractionation and those receiving conventional fractionation to the prostate gland. ","['101 patients provided datasets for analysis (51 men on cranberry capsules and 50 men on beetroot-containing placebo capsules', 'many prostate cancer patients', 'prostate cancer patients', '108 prostate cancer patients were recruited at three New Zealand hospitals between September 2016 and January 2019']","['conventional fractionation or hypo-fractionated radiation therapy (CHHiP', 'Cranberry capsules', 'placebo capsules', 'RICAS', 'cranberry capsules', 'placebo']","['Cystitis severity', 'sensitive RICAS scale', 'symptoms of acute radiation cystitis', 'cystitis severity', ""cystitis severity: modified RTOG, O'Leary interstitial cystitis scale and a sensitive novel radiation induced cystitis assessment scale (RICAS""]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0150098', 'cui_str': 'Data Set'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0453273', 'cui_str': 'Cranberry preparation'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0453112', 'cui_str': 'Beetroot'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0524811', 'cui_str': 'Dose Fractionation, Radiotherapy'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0453273', 'cui_str': 'Cranberry preparation'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0010692', 'cui_str': 'Cystitis'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales'}]","[{'cui': 'C0010692', 'cui_str': 'Cystitis'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0403637', 'cui_str': 'Acute radiation cystitis'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0282488', 'cui_str': 'Ulcerative cystitis'}, {'cui': 'C0205314', 'cui_str': 'New'}]",108.0,0.254135,"No significant difference in cystitis severity was seen between patients receiving hypofractionation and those receiving conventional fractionation to the prostate gland. ","[{'ForeName': 'Patries M', 'Initials': 'PM', 'LastName': 'Herst', 'Affiliation': 'Department of Radiation Therapy, University of Otago, Wellington, New Zealand. Electronic address: patries.herst@otago.ac.nz.'}, {'ForeName': 'Andre', 'Initials': 'A', 'LastName': 'Aumata', 'Affiliation': 'Radiation Oncology Department, Southern Blood and Cancer Centre, Dunedin Hospital, New Zealand.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Sword', 'Affiliation': 'Kathleen Kilgour Centre, Tauranga, New Zealand.'}, {'ForeName': 'Rowan', 'Initials': 'R', 'LastName': 'Jones', 'Affiliation': 'Auckland Radiation Oncology, Epsom, New Zealand.'}, {'ForeName': 'Gordon', 'Initials': 'G', 'LastName': 'Purdie', 'Affiliation': ""Dean's Department, University of Otago, Wellington, New Zealand.""}, {'ForeName': 'Shaun', 'Initials': 'S', 'LastName': 'Costello', 'Affiliation': 'Radiation Oncology Department, Southern Blood and Cancer Centre, Dunedin Hospital, New Zealand.'}]",Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology,['10.1016/j.radonc.2020.05.006'] 1321,32414547,Efficacy of botulinum toxin for treating a gummy smile.,"INTRODUCTION This study was conducted to investigate the efficacy of botulinum toxin applied to the different muscles of patients who have excessive gingival display and to evaluate the return to baseline gingival exposure value. METHODS Twenty-eight patients who had a gummy smile of more than 2 mm were randomly divided into 2 groups. Botulinum toxin was administered equally to the left and right of the levator labii superioris alaeque nasi muscle of group 1 and the orbicularis oris site of group 2. Photographs were taken, and measurements were taken before injection and at 3 days, 15 days, 1 month, 4 months, 5 months, and 6 months after injection. The visual analogue scale was used to assess the level of satisfaction. RESULTS The average amount of visible gingiva in group 1 was 4.92 mm at the beginning of the treatment and 1.92 mm on the 15th day. In group 2, the average amount of visible gingiva was 4.58 mm at the beginning of treatment and 2.16 mm on the 15th day. In both treatment groups, it was determined that the measurements on the sixth month did not return to their initial values. The decrease in gingival appearances in group 1 was greater than in group 2. There was no significant difference between the groups in terms of return to baseline gingival exposure value. In both groups, it was seen that the increase in satisfaction in patients was high. CONCLUSIONS For gummy smile correction, botulinum toxin injection is thought to be an alternative method because it is effective and conservative and has high patient satisfaction.",2020,Botulinum toxin was administered equally to the left and right of the levator labii superioris alaeque nasi muscle of group 1 and the orbicularis oris site of group 2.,"['patients who have excessive gingival display and to evaluate the return to baseline gingival exposure value', 'Twenty-eight patients who had a gummy smile of more than 2\xa0mm']","['botulinum toxin', 'Botulinum toxin', 'botulinum toxin injection']","['visual analogue scale', 'satisfaction', 'average amount of visible gingiva', 'gingival appearances', 'return to baseline gingival exposure value']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0442802', 'cui_str': 'Excessive'}, {'cui': 'C0017562', 'cui_str': 'Gingival structure'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C3696916', 'cui_str': 'Gummy smile'}, {'cui': 'C0439093', 'cui_str': '>'}]","[{'cui': 'C0006055', 'cui_str': 'botulinum toxin'}, {'cui': 'C1321035', 'cui_str': 'Injection of botulinum toxin'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0205379', 'cui_str': 'Visible'}, {'cui': 'C0017562', 'cui_str': 'Gingival structure'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",28.0,0.0146754,Botulinum toxin was administered equally to the left and right of the levator labii superioris alaeque nasi muscle of group 1 and the orbicularis oris site of group 2.,"[{'ForeName': 'Ahmet Fatih', 'Initials': 'AF', 'LastName': 'Cengiz', 'Affiliation': 'Private Practice, Mersin, Turkey.'}, {'ForeName': 'Merve', 'Initials': 'M', 'LastName': 'Goymen', 'Affiliation': 'Department of Orthodontics, Faculty of Dentistry, Gaziantep University, Gaziantep, Turkey. Electronic address: mervegoymen@gmail.com.'}, {'ForeName': 'Cenk', 'Initials': 'C', 'LastName': 'Akcali', 'Affiliation': 'Department of Dermatology, Faculty of Medicine, Gaziantep University, Gaziantep, Turkey.'}]","American journal of orthodontics and dentofacial orthopedics : official publication of the American Association of Orthodontists, its constituent societies, and the American Board of Orthodontics",['10.1016/j.ajodo.2019.07.014'] 1322,32416376,Accelerating prostate stereotactic ablative body radiotherapy: Efficacy and toxicity of a randomized phase II study of 11 versus 29 days overall treatment time (PATRIOT).,"BACKGROUND Prostate stereotactic ablative radiotherapy (SABR) regimens differ in time, dose, and fractionation. We report an update of a multicentre, Canadian randomized phase II study to investigate the impact of overall treatment time on quality of life (QOL), efficacy, and toxicity. METHODS Men with intermediate risk prostate cancer were randomized to 40 Gy in 5 fractions delivered every other day (EOD) versus once per week (QW). Primary outcome was proportion of patients experiencing a minimally clinically important change (MCIC) in acute bowel QOL using EPIC. Secondary outcomes were toxicity, biochemical failure (BF), other QOL domains, and the rate of salvage therapy. FINDINGS 152 men from 3 centers were randomized; the median follow-up was 62 months. Results are described for EOD versus QW. Acute bowel and urinary QOL was reported previously. Late changes in QOL were not significantly different between the two arms. There were 1 (1.3%) vs 3 (2.7%) late grade 3 + GI toxicities (p = 0.36) and 5 (6.7%) vs 2 (2.7%) late grade 3 GU toxicities (p = 0.44). Two and 5 patients had BF (5-year failure rate 3.0 vs 7.2%, p = 0.22); 0 and 4 patients received salvage therapy (p = 0.04). 5-Year OS and CSS was 95.8% and 98.6% with no difference between arms (p = 0.49, p = 0.15). 3 patients in the QW arm developed metastases. INTERPRETATION Although we previously reported that weekly prostate SABR had better bowel and urinary QOL compared to EOD, the updated results show no difference in late toxicity, QOL, BF, or PSA kinetics. Patients should be counseled that QW SABR reduces short-term toxicity compared to QW SABR.",2020,Late changes in QOL were not significantly different between the two arms.,"['152 men from 3 centers', 'Men with intermediate risk prostate cancer']","['Accelerating prostate stereotactic ablative body radiotherapy', 'salvage therapy', 'Prostate stereotactic ablative radiotherapy (SABR']","['late toxicity, QOL, BF, or PSA kinetics', 'Late changes in QOL', 'proportion of patients experiencing a minimally clinically important change (MCIC) in acute bowel QOL using EPIC', 'Acute bowel and urinary QOL', 'bowel and urinary QOL', 'metastases', 'BF (5-year failure rate', 'late grade 3 GU toxicities', 'toxicity, biochemical failure (BF), other QOL domains, and the rate of salvage therapy', '5-Year OS and CSS', 'quality of life (QOL), efficacy, and toxicity', 'late grade 3\xa0+\xa0GI toxicities']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}]","[{'cui': 'C0521110', 'cui_str': 'Accelerated'}, {'cui': 'C0033572', 'cui_str': 'Prostatic'}, {'cui': 'C0729296', 'cui_str': 'Stereotactic'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0085405', 'cui_str': 'Salvage therapy'}]","[{'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0138741', 'cui_str': 'Prostate specific antigen'}, {'cui': 'C0022702', 'cui_str': 'Kinetics'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C1273342', 'cui_str': 'Epithelial cell count'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0085405', 'cui_str': 'Salvage therapy'}, {'cui': 'C0265338', 'cui_str': 'Coffin-Siris syndrome'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",152.0,0.180251,Late changes in QOL were not significantly different between the two arms.,"[{'ForeName': 'Yasir', 'Initials': 'Y', 'LastName': 'Alayed', 'Affiliation': 'Radiation Oncology Unit, Department of Medicine, College of Medicine and College of Medicine Research Center, King Saud University, Saudi Arabia; Oncology Center, King Saud University Medical City, Saudi Arabia; Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Canada.'}, {'ForeName': 'Harvey', 'Initials': 'H', 'LastName': 'Quon', 'Affiliation': 'Tom Baker Cancer Centre, Calgary, Canada.'}, {'ForeName': 'Aldrich', 'Initials': 'A', 'LastName': 'Ong', 'Affiliation': 'CancerCare Manitoba, Winnipeg, Canada.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Cheung', 'Affiliation': 'Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Canada; Department of Radiation Oncology, University of Toronto, Toronto, Canada.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Chu', 'Affiliation': 'Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Canada; Department of Radiation Oncology, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Chung', 'Affiliation': 'Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Canada; Department of Radiation Oncology, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Danny', 'Initials': 'D', 'LastName': 'Vesprini', 'Affiliation': 'Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Canada; Department of Radiation Oncology, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Chowdhury', 'Affiliation': 'CancerCare Manitoba, Winnipeg, Canada.'}, {'ForeName': 'Dilip', 'Initials': 'D', 'LastName': 'Panjwani', 'Affiliation': 'BC Cancer Agency, Abbotsford, Canada.'}, {'ForeName': 'Geordi', 'Initials': 'G', 'LastName': 'Pang', 'Affiliation': 'Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Canada; Department of Radiation Oncology, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Renee', 'Initials': 'R', 'LastName': 'Korol', 'Affiliation': 'Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Canada; Department of Radiation Oncology, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Davidson', 'Affiliation': 'Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Canada; Department of Radiation Oncology, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Ananth', 'Initials': 'A', 'LastName': 'Ravi', 'Affiliation': 'Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Canada; Department of Radiation Oncology, University of Toronto, Toronto, Canada.'}, {'ForeName': 'Boyd', 'Initials': 'B', 'LastName': 'McCurdy', 'Affiliation': 'CancerCare Manitoba, Winnipeg, Canada.'}, {'ForeName': 'Liying', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Canada.'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Mamedov', 'Affiliation': 'Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Canada.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Deabreu', 'Affiliation': 'Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Canada.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Loblaw', 'Affiliation': 'Odette Cancer Centre, Sunnybrook Health Sciences Centre, Toronto, Canada; Department of Radiation Oncology, University of Toronto, Toronto, Canada; Institute of Health Policy Management and Evaluation, University of Toronto, Canada. Electronic address: andrew.loblaw@sunnybrook.ca.'}]",Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology,['10.1016/j.radonc.2020.04.039'] 1323,26844117,Parental education and text messaging reminders as effective community based tools to increase HPV vaccination rates among Mexican American children.,"OBJECTIVE Latino populations, particularly Mexican-Americans who comprise 65% of the Latinos in the U.S., are disproportionately affected by HPV-related diseases. The HPV vaccination completion rates remain low, well below the Healthy People 2020 goal. In this study we assessed the effect of parental education and a text messaging reminder service on HPV vaccine completion rates among eligible children of Mexican American parents. STUDY DESIGN Nonequivalent group study of Mexican parents of HPV vaccine eligible children attended the Health Window program at the Mexican Consulate in New York City, a non-clinical, trusted community setting, during 2012-2013. 69 parents received HPV education onsite, 45 of whom also received a series of text message vaccination reminders. We measured HPV vaccination completion of the youngest eligible children of Mexican parents as the main outcome. RESULTS 98% of those in the education plus text messaging group reported getting the first dose of the vaccine for their child and 87% among those in the educational group only (p = 0.11). 88% of those receiving the 1st dose in the text messaging group reported completing the three doses versus 40% in the educational group only (p = 0.004). CONCLUSIONS Parental text messaging plus education, implemented in a community based setting, was strongly associated with vaccine completion rates among vaccine-eligible Mexican American children. Although pilot in nature, the study achieved an 88% series completion rate in the children of those who received the text messages, significantly higher than current vaccination levels.",2015,"CONCLUSIONS Parental text messaging plus education, implemented in a community based setting, was strongly associated with vaccine completion rates among vaccine-eligible Mexican American children.","['Mexican American children', 'Latino populations, particularly Mexican-Americans who comprise 65% of the Latinos in the U.S., are disproportionately affected by HPV-related diseases', 'youngest eligible children of Mexican parents', 'eligible Mexican American children', 'Nonequivalent group study of Mexican parents of HPV vaccine eligible children attended the Health Window program at the Mexican Consulate in New York City, a non-clinical, trusted community setting, during 2012-2013', 'eligible children of Mexican American parents', '69 parents received']","['Parental education and text messaging reminders', 'HPV education onsite, 45 of whom also received a series of text message vaccination reminders', 'parental education and a text messaging reminder service', 'vaccine']","['HPV vaccination completion', 'HPV vaccine completion rates', 'HPV vaccination rates']","[{'cui': 'C0025884', 'cui_str': 'Chicanas'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0086528', 'cui_str': 'Latinos'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0680063', 'cui_str': 'Child of (finding)'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0030551', 'cui_str': 'Parent of (observable entity)'}, {'cui': 'C1512511', 'cui_str': 'HPV Vaccines'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0557702', 'cui_str': 'Window (physical object)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0027977', 'cui_str': 'New York City'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0237935', 'cui_str': 'Trust'}, {'cui': 'C0009462', 'cui_str': 'Community'}]","[{'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C0205549', 'cui_str': 'Series (qualifier value)'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}]","[{'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C1512511', 'cui_str': 'HPV Vaccines'}]",,0.101571,"CONCLUSIONS Parental text messaging plus education, implemented in a community based setting, was strongly associated with vaccine completion rates among vaccine-eligible Mexican American children.","[{'ForeName': 'Abraham', 'Initials': 'A', 'LastName': 'Aragones', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Memorial Sloan-Kettering Cancer Center, 300 East 66 st 15th Floor, New York, NY 10065, United States.'}, {'ForeName': 'Denise M', 'Initials': 'DM', 'LastName': 'Bruno', 'Affiliation': 'Department of Community Health Sciences, SUNY Downstate School of Public Health, 450 Clarkson Avenue, Brooklyn, New York 11203, NY, United States.'}, {'ForeName': 'Mariane', 'Initials': 'M', 'LastName': 'Ehrenberg', 'Affiliation': 'General Consulate of Mexico in New York, 27 East 39th Street, New York, NY 10016, United States.'}, {'ForeName': 'Josana', 'Initials': 'J', 'LastName': 'Tonda-Salcedo', 'Affiliation': 'General Consulate of Mexico in New York, 27 East 39th Street, New York, NY 10016, United States.'}, {'ForeName': 'Francesca M', 'Initials': 'FM', 'LastName': 'Gany', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Memorial Sloan-Kettering Cancer Center, 300 East 66 st 15th Floor, New York, NY 10065, United States.'}]",Preventive medicine reports,['10.1016/j.pmedr.2015.06.015'] 1324,31599351,Cognitive behavioral therapy in adolescents with early-onset psychosis: a randomized controlled pilot study.,"Cognitive behavioral therapy for psychosis (CBT) is an effective treatment in adult patients with schizophrenia. However, no randomized controlled and blinded trial in adolescents with early-onset psychosis (EOP) has been conducted. Therefore, the present pilot study explores the acceptance, tolerability, feasibility, and safety of a modified CBT in adolescents with EOP. Twenty-five adolescents with EOP were randomized to either 9 months (20 sessions) of CBT + treatment as usual (TAU) or TAU alone. The primary endpoint was the PANSS-positive subscale (P1-7). Secondary endpoints included psychopathology, global functioning, and quality of life (QoL). Acceptance, tolerability, feasibility, and safety were assessed. Blinded assessments took place by the end of the treatment (9 months) and at 24-month follow-up. Despite improvements in both groups and lack of statistical significance between CBT + TAU and TAU regarding the primary endpoint, we observed between-group effect sizes of at least d = 0.39 in favor of CBT + TAU at post-treatment for delusions, negative symptoms, functioning and QoL after the intervention and effect sizes of at least d = 0.35 after 24 months. CBT in EOP was highly acceptable (73.5% agreed to randomization), well-tolerated (83.1% attendance rate, no drop-outs), and safe (one serious adverse event (SAE) in CBT + TAU in comparison with six SAEs in TAU). These findings suggest that CBT adapted to the needs of adolescents with EOP is a promising approach regarding negative symptoms, functioning, and QoL. CBT is a safe and tolerable treatment. However, due to the small sample size and the pilot character of the study, these conclusions are limited, and should be tested in a larger, adequately powered randomized controlled trial.",2020,"Despite improvements in both groups and lack of statistical significance between CBT + TAU and TAU regarding the primary endpoint, we observed between-group effect sizes of at least d = 0.39 in favor of CBT + TAU at post-treatment for delusions, negative symptoms, functioning and QoL after the intervention and effect sizes of at least d = 0.35 after 24 months.","['Twenty-five adolescents with EOP', 'adolescents with early-onset psychosis', 'adult patients with schizophrenia', 'adolescents with early-onset psychosis (EOP', 'adolescents with EOP']","['Cognitive behavioral therapy', 'modified CBT', 'CBT', 'CBT\u2009+\u2009treatment as usual (TAU) or TAU alone']","['tolerated', 'psychopathology, global functioning, and quality of life (QoL', 'Acceptance, tolerability, feasibility, and safety', 'PANSS-positive subscale (P1-7', 'acceptance, tolerability, feasibility, and safety']","[{'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0033975', 'cui_str': 'Psychoses'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1720655', 'cui_str': 'Tau'}]","[{'cui': 'C0033927', 'cui_str': 'Psychopathology'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}]",25.0,0.118217,"Despite improvements in both groups and lack of statistical significance between CBT + TAU and TAU regarding the primary endpoint, we observed between-group effect sizes of at least d = 0.39 in favor of CBT + TAU at post-treatment for delusions, negative symptoms, functioning and QoL after the intervention and effect sizes of at least d = 0.35 after 24 months.","[{'ForeName': 'Hendrik', 'Initials': 'H', 'LastName': 'Müller', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Faculty of Medicine, University Hospital Cologne, Cologne, Germany.'}, {'ForeName': 'Mareike', 'Initials': 'M', 'LastName': 'Kommescher', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Faculty of Medicine, University Hospital Cologne, Cologne, Germany.'}, {'ForeName': 'Jörn', 'Initials': 'J', 'LastName': 'Güttgemanns', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Faculty of Medicine, University Hospital Cologne, Cologne, Germany.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Wessels', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Faculty of Medicine, University Hospital Cologne, Cologne, Germany.'}, {'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Walger', 'Affiliation': 'Department of Childhood and Adolescent Psychiatry and Psychotherapy, Department of Psychiatry and Psychotherapy, Faculty of Medicine, University Hospital Cologne, Cologne, Germany.'}, {'ForeName': 'Gerd', 'Initials': 'G', 'LastName': 'Lehmkuhl', 'Affiliation': 'Department of Childhood and Adolescent Psychiatry and Psychotherapy, Department of Psychiatry and Psychotherapy, Faculty of Medicine, University Hospital Cologne, Cologne, Germany.'}, {'ForeName': 'Kathrin', 'Initials': 'K', 'LastName': 'Kuhr', 'Affiliation': 'Faculty of Medicine, Institute of Medical Statistics and Computational Biology, University Hospital Cologne, Cologne, Germany.'}, {'ForeName': 'Stefanie', 'Initials': 'S', 'LastName': 'Hamacher', 'Affiliation': 'Faculty of Medicine, Institute of Medical Statistics and Computational Biology, University Hospital Cologne, Cologne, Germany.'}, {'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Lehmacher', 'Affiliation': 'Faculty of Medicine, Institute of Medical Statistics and Computational Biology, University Hospital Cologne, Cologne, Germany.'}, {'ForeName': 'Kerstin', 'Initials': 'K', 'LastName': 'Müller', 'Affiliation': 'Kinder- und Jugendwohnheim Leppermühle, Leppermühle 1, 35418, Buseck, Germany.'}, {'ForeName': 'Jutta', 'Initials': 'J', 'LastName': 'Herrlich', 'Affiliation': 'Department of Psychiatry, Psychotherapy and Psychosomatic Medicine, Goethe University Hospital Frankfurt, Theodor-Stern-Kai 7, 60590, Frankfurt am Main, Germany.'}, {'ForeName': 'Georg', 'Initials': 'G', 'LastName': 'Wiedemann', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Klinikum Fulda, Pacelliallee 4, 36043, Fulda, Germany.'}, {'ForeName': 'Dieter', 'Initials': 'D', 'LastName': 'Stösser', 'Affiliation': 'Department of Childhood and Adolescent Psychiatry and Psychotherapy, University of Tübingen, Geissweg 3, 72076, Tübingen, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Klingberg', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Tübingen, Geissweg 3, 72076, Tübingen, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Bechdolf', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Faculty of Medicine, University Hospital Cologne, Cologne, Germany. andreas.bechdolf@vivantes.de.'}]",European child & adolescent psychiatry,['10.1007/s00787-019-01415-4'] 1325,31487406,"Efficacy and safety of tildrakizumab for plaque psoriasis with continuous dosing, treatment interruption, dose adjustments and switching from etanercept: results from phase III studies.","BACKGROUND Chronic psoriasis may require medication adjustments over time. OBJECTIVES To evaluate the efficacy/safety of tildrakizumab in subgroups from the reSURFACE studies (N = 1862) that received continuous dosing, higher/lower dosing, treatment interruption/reinitiation and initiation. METHODS Responders [Psoriasis Area and Severity Index (PASI) ≥ 75%] and partial responders (PASI ≥ 50% to < 75%) in Part 3 of the reSURFACE studies (weeks 28-52 or week 64) who received tildrakizumab 200 mg or 100 mg were rerandomized to the same dosage (T100/T100 or T200/T200), a higher/lower dosage (T100/T200 or T200/T100) or placebo (PBO) (T100/PBO or T200/PBO). Patients receiving PBO who relapsed were reinitiated to tildrakizumab. Etanercept (ETN) week-28 partial responders and nonresponders (PASI < 50%) received tildrakizumab 200 mg (ETN/T200). RESULTS Among T100/T100 and T200/T200 week-28 partial responders, the proportion of patients who achieved as-observed PASI 75 responses increased over time. Among T100/T200 week-28 partial responders, PASI 75 responses increased from week 32 (38·5%) to week 52 (63·2%) and remained consistent in T200/T100 week-28 responders. Among patients who relapsed in the T100/PBO and T200/PBO groups, 86% and 83% of those who reinitiated tildrakizumab achieved PASI 75 by week 64, respectively. Among ETN/T200 week-28 partial responders, PASI 75 responses (nonresponder imputation) increased from week 32 (24·1%) to week 52 (74·7%). PASI 90, PASI 100 and Physician's Global Assessment responses were consistent with PASI 75 results. Treatment was well tolerated. CONCLUSIONS Patients generally fared well with tildrakizumab maintenance, reinitiation, dose adjustment or initiation. What's already known about this topic? Tildrakizumab demonstrated significant efficacy vs. placebo with a positive safety profile during the first 28 weeks of treatment in two randomized double-blind trials. What does this study add? Treatment scenarios with tildrakizumab, such as long-term continuous dosing (up to 64 weeks), treatment interruption/reinitiation and switching from another biologic, can be part of the management of plaque psoriasis with a reasonable expectation of efficacy and tolerability.",2020,"Among ETN/T200 Week 28 partial-responders, PASI 75 responses (non-responder imputation) increased from Weeks 32 (24.1%) to 52 (74.7%).",['Responders (PASI ≥75%) and partial-responders (PASI ≥50%-<75%) in Part 3 (Weeks 28-52 or 64) receiving'],"['tildrakizumab 200 or 100 mg were re-randomised to the same dose (T100/T100 or T200/T200), higher/lower dose (T100/T200 or T200/T100), or placebo (T100/PBO or T200/PBO', 'Etanercept', 'tildrakizumab']","['PASI 90, PASI 100, and PGA responses', 'PASI 75 responses', 'Efficacy and safety', 'tolerated']","[{'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C4043954', 'cui_str': 'tildrakizumab'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0717758', 'cui_str': 'Etanercept'}]","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0085409', 'cui_str': 'Polyendocrinopathies, Autoimmune'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.0289187,"Among ETN/T200 Week 28 partial-responders, PASI 75 responses (non-responder imputation) increased from Weeks 32 (24.1%) to 52 (74.7%).","[{'ForeName': 'A B', 'Initials': 'AB', 'LastName': 'Kimball', 'Affiliation': 'Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, MA, U.S.A.'}, {'ForeName': 'K A', 'Initials': 'KA', 'LastName': 'Papp', 'Affiliation': 'K. Papp Clinical Research and Probity Medical Research, Waterloo, ON, Canada.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Reich', 'Affiliation': 'Translational Research in Inflammatory Skin Diseases, Institute for Health Services Research in Dermatology and Nursing, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Gooderham', 'Affiliation': 'Skin Centre for Dermatology and Probity Medical Research, Peterborough, ON, Canada.'}, {'ForeName': 'Q', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, U.S.A.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Cichanowitz', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, U.S.A.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'La Rosa', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, U.S.A.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Blauvelt', 'Affiliation': 'Oregon Medical Research Center, Portland, OR, U.S.A.'}]",The British journal of dermatology,['10.1111/bjd.18484'] 1326,32043667,A mindfulness-based intervention for caregivers of allogeneic hematopoietic stem cell transplant patients: Pilot results.,"Despite high levels of stress, there are few empirically supported stress management interventions for caregivers of allogeneic hematopoietic stem cell transplant (HCT) cancer patients. This study examined the feasibility, acceptability, and various stress-related outcomes from pre- to post-treatment of a pilot, single-arm trial of a 6-week mindfulness-based intervention (FOCUS) for stress management. Caregivers (N = 21; 76% female; mean age = 57.43) were enrolled prior to patient transplant and received FOCUS during the first 90 days post-transplant. Findings indicated that FOCUS was highly feasible and acceptable (e.g., 71% attended at least four of six sessions; 100% reported using the skills learned at follow-up; high treatment engagement). Significant increases in mindfulness, post-traumatic growth, and general mental health were observed, along with significant decreases in negative affect (all ps < .05).",2020,"Significant increases in mindfulness, post-traumatic growth, and general mental health were observed, along with significant decreases in negative affect (all ps < .05).","['Caregivers (N = 21; 76% female; mean age = 57.43', 'caregivers of allogeneic hematopoietic stem cell transplant patients', 'caregivers of allogeneic hematopoietic stem cell transplant (HCT) cancer patients']","['FOCUS', '6-week mindfulness-based intervention (FOCUS']","['mindfulness, post-traumatic growth, and general mental health']","[{'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0018956', 'cui_str': 'Progenitor Cells, Hematopoietic'}, {'cui': 'C0332835', 'cui_str': 'Grafts'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}]","[{'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0332663', 'cui_str': 'Traumatic (qualifier value)'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}]",,0.0162117,"Significant increases in mindfulness, post-traumatic growth, and general mental health were observed, along with significant decreases in negative affect (all ps < .05).","[{'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Vinci', 'Affiliation': 'Moffitt Cancer Center, Tampa, Florida.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Pidala', 'Affiliation': 'Moffitt Cancer Center, Tampa, Florida.'}, {'ForeName': 'Penny', 'Initials': 'P', 'LastName': 'Lau', 'Affiliation': 'Moffitt Cancer Center, Tampa, Florida.'}, {'ForeName': 'Maija', 'Initials': 'M', 'LastName': 'Reblin', 'Affiliation': 'Moffitt Cancer Center, Tampa, Florida.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Jim', 'Affiliation': 'Moffitt Cancer Center, Tampa, Florida.'}]",Psycho-oncology,['10.1002/pon.5353'] 1327,30681726,Low Risk of Variceal Bleeding in Patients With Cirrhosis After Variceal Screening Stratified by Liver/Spleen Stiffness.,"We previously demonstrated the possible noninferiority of a screening strategy for varices guided by liver and spleen stiffness measurement (LSSM) compared to universal endoscopic screening in detecting clinically significant varices in patients with cirrhosis. We now report the long-term outcome of the patients recruited in this trial for incident variceal bleeding and other hepatic events. This was a prospective follow-up study of a noninferiority, open-label, randomized controlled trial (NCT02024347) of 548 adult patients with known chronic liver diseases, radiological evidence of liver cirrhosis, and compensated liver function. The primary outcome of this prospective study was incident variceal bleeding confirmed with upper endoscopy. Between October 2013 and June 2016, 548 patients were randomized to an LSSM arm (n = 274) and a conventional arm (n = 274). Patients in both study arms were predominantly middle-aged men (mean age 59 years, male 68.9%) with viral hepatitis-related cirrhosis (85%). Upper endoscopy examination was performed in 127 (46.4%) patients in the LSSM arm and 263 (96.0%) in the conventional arm. During the follow-up period of 41.3 ± 12.6 months, 12/274 patients in the LSSM arm (4.4%) and 11/274 in the conventional arm (4.0%) developed incident variceal bleeding (log-rank test P = 0.724). The incident rates of hepatic events were also similar in both arms (P = 0.327). Conclusions: Patients with liver cirrhosis who had undergone LSSM-guided variceal screening were at similarly low risk of incident variceal bleeding in the future; patients with cirrhosis may first have LSSM measured to save up to half of the upper endoscopy examinations.",2019,Upper endoscopy examination was performed in 127 (46.4%) patients in the LSSM arm and 263 (96.0%) in the conventional arm.,"['Patients in both study arms were predominantly middle-aged men (mean age 59 years, male 68.9%) with viral hepatitis-related cirrhosis (85', 'Between October 2013 and June 2016, 548 patients', 'patients recruited in this trial for incident variceal bleeding and other hepatic events', 'Patients With Cirrhosis', 'Conclusions: Patients with liver cirrhosis who had undergone LSSM-guided variceal screening', '548 adult patients with known chronic liver diseases, radiological evidence of liver cirrhosis, and compensated liver function', 'patients with cirrhosis']","['LSSM', 'universal endoscopic screening']","['incident rates of hepatic events', 'Upper endoscopy examination', 'incident variceal bleeding', 'incident variceal bleeding confirmed with upper endoscopy', 'Low Risk of Variceal Bleeding']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0205847', 'cui_str': 'Middle Aged'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0042721', 'cui_str': 'Viral hepatitis (disorder)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C1623038', 'cui_str': 'Cirrhosis'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0023890', 'cui_str': 'Hepatic Cirrhosis'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205309', 'cui_str': 'Known (qualifier value)'}, {'cui': 'C0341439', 'cui_str': 'Chronic liver disease (disorder)'}, {'cui': 'C0332120', 'cui_str': 'Evidence of (contextual qualifier) (qualifier value)'}, {'cui': 'C0205432', 'cui_str': 'Compensated (qualifier value)'}, {'cui': 'C0232741', 'cui_str': 'Liver function (observable entity)'}]","[{'cui': 'C0175671', 'cui_str': 'Universal (qualifier value)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}]","[{'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C1273867', 'cui_str': 'Examination (heading)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C3538919', 'cui_str': 'Low risk (qualifier value)'}]",548.0,0.131328,Upper endoscopy examination was performed in 127 (46.4%) patients in the LSSM arm and 263 (96.0%) in the conventional arm.,"[{'ForeName': 'Grace Lai-Hung', 'Initials': 'GL', 'LastName': 'Wong', 'Affiliation': 'Institute of Digestive Disease, The Chinese University of Hong Kong, Shatin, Hong Kong.'}, {'ForeName': 'Lilian Yan', 'Initials': 'LY', 'LastName': 'Liang', 'Affiliation': 'Department of Medicine and Therapeutics, The Chinese University of Hong Kong, Shatin, Hong Kong.'}, {'ForeName': 'Raymond', 'Initials': 'R', 'LastName': 'Kwok', 'Affiliation': 'Institute of Digestive Disease, The Chinese University of Hong Kong, Shatin, Hong Kong.'}, {'ForeName': 'Aric Josun', 'Initials': 'AJ', 'LastName': 'Hui', 'Affiliation': 'Alice Ho Miu Ling Nethersole Hospital, Hong Kong.'}, {'ForeName': 'Yee-Kit', 'Initials': 'YK', 'LastName': 'Tse', 'Affiliation': 'Institute of Digestive Disease, The Chinese University of Hong Kong, Shatin, Hong Kong.'}, {'ForeName': 'Henry Lik-Yuen', 'Initials': 'HL', 'LastName': 'Chan', 'Affiliation': 'Institute of Digestive Disease, The Chinese University of Hong Kong, Shatin, Hong Kong.'}, {'ForeName': 'Vincent Wai-Sun', 'Initials': 'VW', 'LastName': 'Wong', 'Affiliation': 'Institute of Digestive Disease, The Chinese University of Hong Kong, Shatin, Hong Kong.'}]","Hepatology (Baltimore, Md.)",['10.1002/hep.30522'] 1328,28064421,Impact of a Randomized Controlled Trial to Reduce Bedsharing on Breastfeeding Rates and Duration for African-American Infants.,"Bedsharing is associated with both increased breastfeeding and increased risk of sudden and unexpected infant deaths. The objective was to determine impact of sleep location and counseling about sleep location on breastfeeding exclusivity and duration in African-Americans. 1194 mothers of newborns were randomized to receive messaging emphasizing either safe sleep practices to reduce SIDS risk or safe sleep practices to prevent SIDS/suffocation. Mothers completed four interviews in the 6 months after delivery. The most common sleep arrangement was roomsharing without bedsharing (""roomsharing""). Duration of any breastfeeding was 6.1 and 5.3 weeks for infants who usually bedshared or roomshared, respectively (p = 0.01). Duration of exclusive breastfeeding was 3.0 and 1.6 weeks for infants who usually bedshared or roomshared, respectively (p < 0.001). Group assignment did not affect breastfeeding duration. The most common sleep arrangement for African-American infants <6 months was roomsharing. An intervention designed to discourage bedsharing did not impact breastfeeding duration.",2017,Group assignment did not affect breastfeeding duration.,"['1194 mothers of newborns', 'African-Americans', 'African-American Infants']",['messaging emphasizing either safe sleep practices to reduce SIDS risk or safe sleep practices to prevent SIDS/suffocation'],"['Breastfeeding Rates and Duration', 'Duration of any breastfeeding', 'Duration of exclusive breastfeeding', 'breastfeeding duration']","[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}]","[{'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0038644', 'cui_str': 'SIDS'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0004044', 'cui_str': 'Suffocation'}]","[{'cui': 'C1623040', 'cui_str': 'Breastfeeding (mother)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0242205', 'cui_str': 'Breast Feeding, Exclusive'}]",,0.11235,Group assignment did not affect breastfeeding duration.,"[{'ForeName': 'Rachel Y', 'Initials': 'RY', 'LastName': 'Moon', 'Affiliation': 'Division of General Pediatrics, Department of Pediatrics, University of Virginia, PO Box 800386, Charlottesville, VA, 22908, USA. rym4z@virginia.edu.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Mathews', 'Affiliation': ""Division of General Pediatrics and Community Health, Children's National Medical Center, Washington, DC, USA.""}, {'ForeName': 'Brandi L', 'Initials': 'BL', 'LastName': 'Joyner', 'Affiliation': ""Division of General Pediatrics and Community Health, Children's National Medical Center, Washington, DC, USA.""}, {'ForeName': 'Rosalind P', 'Initials': 'RP', 'LastName': 'Oden', 'Affiliation': ""Division of General Pediatrics and Community Health, Children's National Medical Center, Washington, DC, USA.""}, {'ForeName': 'Jianping', 'Initials': 'J', 'LastName': 'He', 'Affiliation': ""Center for Translational Science, Children's National Medical Center, Washington, DC, USA.""}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'McCarter', 'Affiliation': ""Center for Translational Science, Children's National Medical Center, Washington, DC, USA.""}]",Journal of community health,['10.1007/s10900-016-0307-2'] 1329,31567876,Effect of LncRNA MIAT on Prognosis of Hand-assisted Laparoscopic or Laparoscopic-assisted Colectomy for Colorectal Cancer.,"PURPOSE The current study aims to explore the effect of myocardial infarction associated transcript (MIAT) level on the long-term prognosis of hand-assisted laparoscopic colectomy (HALC) or laparoscopic-assisted colectomy (LAC) for colorectal cancer (CC). MATERIALS AND METHODS A total of 320 CC patients were included. Patients were randomized into HALC and LAC group. RESULTS MIAT level in CC tissue was upregulated, and had a significant positive association with its level in serum. MIAT levels in both CC tissue and serum were correlated with lymph node metastasis and histologic grading. Survival analysis showed that the overall survival rate in 3 years after operation was significantly lower in HALC-High MIAT group (P<0.05). When MIAT level is <10.9 in CC tissue or 8.7 in serum, 100% of patients who underwent HALC will be alive for >3 years. CONCLUSIONS For patients with low MIAT level, both HALC and LAC are available, otherwise, LAC is more recommended.",2019,Survival analysis showed that the overall survival rate in 3 years after operation was significantly lower in HALC-High MIAT group (P<0.05).,"['Colorectal Cancer', '320 CC patients were included']","['myocardial infarction associated transcript (MIAT) level', 'HALC and LAC', 'LncRNA MIAT', 'Laparoscopic or Laparoscopic-assisted Colectomy', 'hand-assisted laparoscopic colectomy (HALC) or laparoscopic-assisted colectomy (LAC']","['overall survival rate', 'MIAT levels']","[{'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C4517711', 'cui_str': '320 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C3494264', 'cui_str': 'Long Non-Coding RNA'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0009274', 'cui_str': 'Large Bowel Resection'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C1517722', 'cui_str': 'Laparoscopic colectomy'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",320.0,0.0564155,Survival analysis showed that the overall survival rate in 3 years after operation was significantly lower in HALC-High MIAT group (P<0.05).,"[{'ForeName': 'Chaofeng', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'Department of General Surgery, China-Japan Friendship Hospital, Beijing, P.R. China.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Tang', 'Affiliation': ''}, {'ForeName': 'Wenyue', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': ''}]","Surgical laparoscopy, endoscopy & percutaneous techniques",['10.1097/SLE.0000000000000728'] 1330,31563980,Evaluating the effects of parenting styles dimensions on adolescent drug use: secondary analysis of #Tamojunto randomized controlled trial.,"The present study examined parenting style dimensions (demandingness and responsiveness) as predictors of adolescent drug use and also evaluated whether parenting styles dimensions moderate the effects of the implemented prevention program. 6.391 students in the 7th and 8th grades at 72 Brazilian public schools participated in a three-wave randomized controlled trial to evaluate a school drug-use prevention program. We used structural equation modeling to test if baseline parenting style dimensions (demandingness and responsiveness) would predict the use of drugs (alcohol, binge drinking, cannabis, inhalants, and tobacco) after 21 months. Additionally, we evaluated an interaction version of the above-described model to test if the effect of the prevention program would be moderated by either or both parenting style dimensions. Higher levels of parent demandingness predicted lower chances of adolescent drug use (e.g., Cigarette use OR 0.76, 95% CI 0.64-0.89); responsiveness on the five outcomes showed p value superior to 0.01. The effect of the #Tamojunto intervention is unlikely to be conditioned to either parenting style dimensions on the assessed outcomes.Clinical trial registration Brazilian Register of Clinical Trials (REBEC): #RBR-4mnv5g ( https://www.ensaiosclinicos.gov.br/rg/?q=tamojunto ).",2020,The effect of the #Tamojunto intervention is unlikely to be conditioned to either parenting style dimensions on the assessed outcomes.,['6.391\xa0students in the 7th and 8th grades at 72 Brazilian public schools'],"['Tamojunto intervention', 'school drug-use prevention program', 'parenting styles dimensions']",[],"[{'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0557800', 'cui_str': 'Public school (environment)'}]","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0449889', 'cui_str': 'Drug used (attribute)'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0439534', 'cui_str': 'Dimensions (qualifier value)'}]",[],,0.0728107,The effect of the #Tamojunto intervention is unlikely to be conditioned to either parenting style dimensions on the assessed outcomes.,"[{'ForeName': 'Juliana Y', 'Initials': 'JY', 'LastName': 'Valente', 'Affiliation': 'Department of Preventive Medicine, Universidade Federal de São Paulo, Rua Botucatu, 740, São Paulo, Brazil.'}, {'ForeName': 'Hugo', 'Initials': 'H', 'LastName': 'Cogo-Moreira', 'Affiliation': 'Department of Psychiatry, Universidade Federal de São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Zila M', 'Initials': 'ZM', 'LastName': 'Sanchez', 'Affiliation': 'Department of Preventive Medicine, Universidade Federal de São Paulo, Rua Botucatu, 740, São Paulo, Brazil. zila.sanchez@unifesp.br.'}]",European child & adolescent psychiatry,['10.1007/s00787-019-01410-9'] 1331,32492600,Cross-fading motives for simultaneous alcohol and marijuana use: Associations with young adults' use and consequences across days.,"BACKGROUND Many young adults engage in simultaneous alcohol and marijuana (SAM) use so that their effects overlap. Little is known about motivations for dual substance use and associations with use and consequences. This study examined daily-level associations between cross-fading motives and levels of alcohol and marijuana use and consequences. METHODS Young adults who reported SAM use in the month prior were surveyed in two 14-day bursts. Data included 1049 SAM use days from 281 young adults (age 18-25; M age = 21.80, SD = 2.16; 50 % women). Multilevel models assessed between- and within-person effects of cross-fading motives (i.e., to enhance the effects of marijuana and/or alcohol use by using them simultaneously) on alcohol and marijuana use and consequences, after adjusting for general enhancement, social, coping, and conformity motives and the amount of alcohol and marijuana used that day. RESULTS On 76 % of SAM use days, participants endorsed cross-fading motives (i.e., to enhance the effect of alcohol or marijuana or to get drunk and high at the same time). Having stronger cross-fading motives was associated with greater alcohol use, perceived intoxication, and positive alcohol consequences at the between- and within-person levels. In addition, between-person, individuals who reported stronger cross-fading motives on average reported more negative alcohol consequences and positive marijuana consequences on average. Cross-fading motives on a given day were not associated with marijuana use or marijuana consequences that day. CONCLUSIONS Cross-fading motives were common and varied from day to day. Understanding the motivational context for dual substance use may support future interventions for cross-fading.",2020,"Cross-fading motives on a given day were not associated with marijuana use or marijuana consequences that day. ","['Data included 1049 SAM use days from 281 young adults (age 18-25; M age = 21.80, SD = 2.16; 50 % women', 'Young adults who reported SAM use in the month prior were surveyed in two 14-day bursts']",[],['negative alcohol consequences and positive marijuana consequences'],"[{'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0024810', 'cui_str': 'Marihuana Smoking'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0450335', 'cui_str': '18/25'}, {'cui': 'C4517627', 'cui_str': '2.16'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}]",[],"[{'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0686907', 'cui_str': 'Consequence of'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0024808', 'cui_str': 'Marihuana'}]",1049.0,0.0152649,"Cross-fading motives on a given day were not associated with marijuana use or marijuana consequences that day. ","[{'ForeName': 'Megan E', 'Initials': 'ME', 'LastName': 'Patrick', 'Affiliation': ""Institute for Translational Research in Children's Mental Health and Institute of Child Development, University of Minnesota, 1100 Washington Ave S., Suite 101, Minneapolis, MN 55415, USA. Electronic address: mpatrick@umn.edu.""}, {'ForeName': 'Charles B', 'Initials': 'CB', 'LastName': 'Fleming', 'Affiliation': 'University of Washington, Department of Psychiatry and Behavioral Sciences, 1100 NE 45th St., Suite 300, Seattle, WA, 98105, USA.'}, {'ForeName': 'Anne M', 'Initials': 'AM', 'LastName': 'Fairlie', 'Affiliation': 'University of Washington, Department of Psychiatry and Behavioral Sciences, 1100 NE 45th St., Suite 300, Seattle, WA, 98105, USA.'}, {'ForeName': 'Christine M', 'Initials': 'CM', 'LastName': 'Lee', 'Affiliation': 'University of Washington, Department of Psychiatry and Behavioral Sciences, 1100 NE 45th St., Suite 300, Seattle, WA, 98105, USA.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2020.108077'] 1332,27265814,Family Caregiver Depressive Symptom and Grief Outcomes From the ENABLE III Randomized Controlled Trial.,"CONTEXT Little is known about whether early palliative care (EPC) support for family caregivers (CGs) impacts depressive symptoms and grief after care recipients die. OBJECTIVES To assess after-death CG depressive symptom and grief scores for early compared to delayed group CGs. METHODS We conducted a randomized controlled trial (10/2010-9/2013) of an EPC telehealth intervention for CGs (n = 123) initiated at the time of care recipients' advanced cancer diagnosis (early group) or 12 weeks later (delayed group) in a rural comprehensive cancer center, affiliated clinics, and a Veterans Administration medical center. The ENABLE [Educate, Nurture, Advise, Before Life Ends] CG intervention consisted of three weekly sessions, monthly follow-up, and a bereavement call. CGs completed the Center for Epidemiological Study-Depression (CES-D) scale and the Prigerson Inventory of Complicated Grief-Short Form (PG13) 8-12 weeks after care recipients' deaths. Crude and covariate-adjusted between-group differences were estimated and tested using general linear models. RESULTS For care recipients who died (n = 70), 44 CGs (early: n = 19; delayed: n = 25) completed after-death questionnaires. Mean depressive symptom scores (CES-D) for the early group was 14.6 (SD = 10.7) and for the delayed group was 17.6 (SD = 11.8). Mean complicated grief scores (PG13) for the early group was 22.7 (SD = 4.9) and for the delayed group was 24.9 (SD = 6.9). Adjusted between-group differences were not statistically significant (CES-D: d = 0.07, P = 0.88; PG13: d = -0.21, P = 0.51). CONCLUSION CGs' depressive symptom and complicated grief scores 8-12 weeks after care recipients' deaths were not statistically different based on the timing of EPC support. The impact of timing of CG EPC interventions on CGs bereavement outcomes requires further investigation.",2016,"CONCLUSION CGs' depressive symptom and complicated grief scores 8-12 weeks after care recipients' deaths were not statistically different based on the timing of EPC support.","['For care recipients who died (n\xa0=\xa070), 44 CGs (early: n\xa0=\xa019; delayed: n\xa0=\xa025) completed after-death questionnaires', ""CGs (n\xa0=\xa0123) initiated at the time of care recipients' advanced cancer diagnosis (early group) or 12\xa0weeks later (delayed group) in a rural comprehensive cancer center, affiliated clinics, and a Veterans Administration medical center""]","['EPC telehealth intervention', 'CG intervention', 'CG EPC interventions']","[""CGs' depressive symptom and complicated grief scores"", 'Family Caregiver Depressive Symptom and Grief Outcomes', 'Mean complicated grief scores (PG13', 'death CG depressive symptom and grief scores', 'Mean depressive symptom scores (CES-D']","[{'cui': 'C1546956', 'cui_str': 'Dead (finding)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0565990', 'cui_str': 'Medical center (environment)'}]","[{'cui': 'C0169014', 'cui_str': 'erucylphosphocholine'}, {'cui': 'C1328956', 'cui_str': 'eHealth'}]","[{'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0018235', 'cui_str': 'Grief'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0086279', 'cui_str': 'Family Caregivers'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",,0.145247,"CONCLUSION CGs' depressive symptom and complicated grief scores 8-12 weeks after care recipients' deaths were not statistically different based on the timing of EPC support.","[{'ForeName': 'J Nicholas', 'Initials': 'JN', 'LastName': 'Dionne-Odom', 'Affiliation': 'School of Nursing, Department of Medicine, University of Alabama at Birmingham, Birmingham, Alabama, USA.'}, {'ForeName': 'Andres', 'Initials': 'A', 'LastName': 'Azuero', 'Affiliation': 'School of Nursing, Department of Medicine, University of Alabama at Birmingham, Birmingham, Alabama, USA.'}, {'ForeName': 'Kathleen D', 'Initials': 'KD', 'LastName': 'Lyons', 'Affiliation': 'Department of Psychiatry, Geisel School of Medicine at Dartmouth, Hanover, New Hampshire, USA.'}, {'ForeName': 'Jay G', 'Initials': 'JG', 'LastName': 'Hull', 'Affiliation': 'Department of Psychological and Brain Sciences, Dartmouth College, Hanover, New Hampshire, USA.'}, {'ForeName': 'Anna T', 'Initials': 'AT', 'LastName': 'Prescott', 'Affiliation': 'Department of Psychological and Brain Sciences, Dartmouth College, Hanover, New Hampshire, USA.'}, {'ForeName': 'Tor', 'Initials': 'T', 'LastName': 'Tosteson', 'Affiliation': 'Biostatistics Shared Resource, Norris Cotton Cancer Center, Lebanon, New Hampshire, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Frost', 'Affiliation': 'Department of Medicine, Hematology/Oncology, Geisel School of Medicine at Dartmouth and Norris Cotton Cancer Center, Lebanon, New Hampshire, USA.'}, {'ForeName': 'Konstantin H', 'Initials': 'KH', 'LastName': 'Dragnev', 'Affiliation': 'Department of Medicine, Hematology/Oncology, Geisel School of Medicine at Dartmouth and Norris Cotton Cancer Center, Lebanon, New Hampshire, USA.'}, {'ForeName': 'Marie A', 'Initials': 'MA', 'LastName': 'Bakitas', 'Affiliation': 'School of Nursing, Department of Medicine, University of Alabama at Birmingham, Birmingham, Alabama, USA; Division of Gerontology, Geriatrics, and Palliative Care, Department of Medicine, University of Alabama at Birmingham, Birmingham, Alabama, USA. Electronic address: mbakitas@uab.edu.'}]",Journal of pain and symptom management,['10.1016/j.jpainsymman.2016.03.014'] 1333,29265379,Pharmacogenetic Effects of Naltrexone in Individuals of East Asian Descent: Human Laboratory Findings from a Randomized Trial.,"BACKGROUND Genetic variation in the endogenous opioid system has been identified as 1 potential source of individual variability in naltrexone treatment outcomes. The majority of naltrexone pharmacogenetic studies have focused on a particular single nucleotide polymorphism (SNP) of the mu-opioid receptor gene (OPRM1; rs1799971; commonly known as the Asn40Asp SNP) in Caucasian samples with decidedly mixed results. The goal of this study was to test the pharmacogenetic effects of naltrexone on subjective response to alcohol and self-administration of alcohol in individuals of East Asian descent. We hypothesized that naltrexone, compared with placebo, would potentiate the aversive and sedative effects of alcohol and reduce alcohol self-administration to a greater extent in Asp40 carriers. METHODS Participants (N = 77; Asn40Asn, n = 29; Asn40Asp, n = 34, and Asp40Asp, n = 14) completed 2 double-blinded and counterbalanced experimental sessions: one after taking naltrexone (50 mg/d) for 5 days and one after taking matched placebo for 5 days. In each experimental session, participants received a priming dose of intravenous alcohol up to the breath alcohol concentration target of 0.06 g/dl which was immediately followed by an alcohol self-administration period (1 hour). RESULTS There were no pharmacogenetic effects observed for alcohol-induced stimulation, sedation, craving for alcohol, or alcohol self-administration in the laboratory. During the self-administration period, Asp40 carriers consumed fewer drinks and had a longer latency to first drink as compared to Asn40 homozygotes. CONCLUSIONS These findings in East Asians add to the mixed literature on naltrexone pharmacogenetics from predominantly Caucasian samples and highlight the complexity of these effects and their overall limited replicability. It is plausible that a consistent pharmacogenetic effect in tightly controlled preclinical and experimental medicine models ""fades"" in more complex and heterogeneous settings and samples.",2018,"There were no pharmacogenetic effects observed for alcohol-induced stimulation, sedation, craving for alcohol, or alcohol self-administration in the laboratory.","['individuals of East Asian descent', 'Caucasian samples with decidedly mixed results', 'Individuals of East Asian Descent', 'Participants (N\xa0=\xa077; Asn40Asn, n\xa0=\xa029; Asn40Asp, n\xa0=\xa034, and Asp40Asp, n\xa0=\xa014']","['intravenous alcohol', 'naltrexone', 'Naltrexone', 'placebo']","['alcohol-induced stimulation, sedation, craving for alcohol, or alcohol self-administration', 'subjective response']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0078988', 'cui_str': 'Asians'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C1274040', 'cui_str': 'Result'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0027360', 'cui_str': 'Naltrexone'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0556385', 'cui_str': 'Craving for alcohol (finding)'}, {'cui': 'C0036589', 'cui_str': 'Self Administration'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}]",,0.0813348,"There were no pharmacogenetic effects observed for alcohol-induced stimulation, sedation, craving for alcohol, or alcohol self-administration in the laboratory.","[{'ForeName': 'Lara A', 'Initials': 'LA', 'LastName': 'Ray', 'Affiliation': 'Department of Psychology, University of California, Los Angeles, Los Angeles, California.'}, {'ForeName': 'ReJoyce', 'Initials': 'R', 'LastName': 'Green', 'Affiliation': 'Department of Psychology, University of California, Los Angeles, Los Angeles, California.'}, {'ForeName': 'Daniel J O', 'Initials': 'DJO', 'LastName': 'Roche', 'Affiliation': 'Department of Psychology, University of California, Los Angeles, Los Angeles, California.'}, {'ForeName': 'Spencer', 'Initials': 'S', 'LastName': 'Bujarski', 'Affiliation': 'Department of Psychology, University of California, Los Angeles, Los Angeles, California.'}, {'ForeName': 'Emily E', 'Initials': 'EE', 'LastName': 'Hartwell', 'Affiliation': 'Department of Psychology, University of California, Los Angeles, Los Angeles, California.'}, {'ForeName': 'Aaron C', 'Initials': 'AC', 'LastName': 'Lim', 'Affiliation': 'Department of Psychology, University of California, Los Angeles, Los Angeles, California.'}, {'ForeName': 'Taylor', 'Initials': 'T', 'LastName': 'Rohrbaugh', 'Affiliation': 'Department of Psychology, University of California, Los Angeles, Los Angeles, California.'}, {'ForeName': 'Dara', 'Initials': 'D', 'LastName': 'Ghahremani', 'Affiliation': 'Department of Psychiatry and Biobehavioral Sciences, University of California, Los Angeles, Los Angeles, California.'}, {'ForeName': 'Kent', 'Initials': 'K', 'LastName': 'Hutchison', 'Affiliation': 'Department of Psychology, University of Colorado, Boulder, Colorado.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Miotto', 'Affiliation': 'Department of Psychiatry and Biobehavioral Sciences, University of California, Los Angeles, Los Angeles, California.'}]","Alcoholism, clinical and experimental research",['10.1111/acer.13586'] 1334,31363948,Proactive outreach tobacco treatment for socioeconomically disadvantaged smokers with serious mental illness.,"Smokers with serious mental illness (SMI) face individual, interpersonal, and healthcare provider barriers to cessation treatment utilization and smoking abstinence. Proactive outreach strategies are designed to address these barriers by promoting heightened contact with smokers and facilitating access to evidence-based treatments. The present study examined the effect of proactive outreach among smokers with SMI (n = 939) who were enrolled in the publicly subsidized Minnesota Health Care Programs (MHCP) and compared this effect to that observed among MHCP smokers without SMI (n = 1382). Relative to usual care, the intervention increased treatment utilization among those with SMI (52.1% vs 40.0%, p = 0.002) and without SMI (39.3% vs 25.4%, p < 0.001). The intervention also increased prolonged smoking abstinence among those with SMI (14.9% vs 9.4%, p = 0.010) and without SMI (17.7% vs 13.6%, p = 0.09). Findings suggest that implementation of proactive outreach within publicly subsidized healthcare systems may alleviate the burden of smoking in this vulnerable population. Trial Registration ClinicalTrials.gov identifier: NCT01123967.",2020,"Relative to usual care, the intervention increased treatment utilization among those with SMI (52.1% vs 40.0%, p = 0.002) and without SMI (39.3% vs 25.4%, p < 0.001).","['Smokers with serious mental illness (SMI', 'smokers with SMI (n\u2009=\u2009939) who were enrolled in the publicly subsidized Minnesota Health Care Programs (MHCP) and compared this effect to that observed among MHCP smokers without SMI (n\u2009=\u20091382', 'socioeconomically disadvantaged smokers with serious mental illness']","['proactive outreach', 'Proactive outreach tobacco treatment']","['treatment utilization', 'prolonged smoking abstinence']","[{'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder (disorder)'}, {'cui': 'C0915075', 'cui_str': 'samarium diiodide'}, {'cui': 'C0026183', 'cui_str': 'Minnesota'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C3875135', 'cui_str': 'Observes (attribute)'}]","[{'cui': 'C0040329', 'cui_str': 'Tobacco Products'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0042153', 'cui_str': 'use'}, {'cui': 'C0439590', 'cui_str': 'Prolonged (qualifier value)'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}]",1382.0,0.0265834,"Relative to usual care, the intervention increased treatment utilization among those with SMI (52.1% vs 40.0%, p = 0.002) and without SMI (39.3% vs 25.4%, p < 0.001).","[{'ForeName': 'Patrick J', 'Initials': 'PJ', 'LastName': 'Hammett', 'Affiliation': 'VA HSR&D Center for Care Delivery and Outcomes Research (CCDOR), VA Medical Center (152), Minneapolis VA Health Care System, Minneapolis, MN, USA. hamm0311@umn.edu.'}, {'ForeName': 'Harry A', 'Initials': 'HA', 'LastName': 'Lando', 'Affiliation': 'Division of Epidemiology and Community Health, University of Minnesota School of Public Health, Minneapolis, MN, USA.'}, {'ForeName': 'Darin J', 'Initials': 'DJ', 'LastName': 'Erickson', 'Affiliation': 'Division of Epidemiology and Community Health, University of Minnesota School of Public Health, Minneapolis, MN, USA.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Widome', 'Affiliation': 'Division of Epidemiology and Community Health, University of Minnesota School of Public Health, Minneapolis, MN, USA.'}, {'ForeName': 'Brent C', 'Initials': 'BC', 'LastName': 'Taylor', 'Affiliation': 'VA HSR&D Center for Care Delivery and Outcomes Research (CCDOR), VA Medical Center (152), Minneapolis VA Health Care System, Minneapolis, MN, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Nelson', 'Affiliation': 'VA HSR&D Center for Care Delivery and Outcomes Research (CCDOR), VA Medical Center (152), Minneapolis VA Health Care System, Minneapolis, MN, USA.'}, {'ForeName': 'Sandra J', 'Initials': 'SJ', 'LastName': 'Japuntich', 'Affiliation': 'Hennepin Healthcare Research Institute, Hennepin County Medical Center, Minneapolis, MN, USA.'}, {'ForeName': 'Steven S', 'Initials': 'SS', 'LastName': 'Fu', 'Affiliation': 'VA HSR&D Center for Care Delivery and Outcomes Research (CCDOR), VA Medical Center (152), Minneapolis VA Health Care System, Minneapolis, MN, USA.'}]",Journal of behavioral medicine,['10.1007/s10865-019-00083-8'] 1335,28024930,Urine Fibrosis Markers and Risk of Allograft Failure in Kidney Transplant Recipients: A Case-Cohort Ancillary Study of the FAVORIT Trial.,"BACKGROUND Kidney tubulointerstitial fibrosis marks risk for allograft failure in kidney transplant recipients, but is poorly captured by estimated glomerular filtration rate (eGFR) or urine albumin-creatinine ratio (ACR). Whether urinary markers of tubulointerstitial fibrosis can noninvasively identify risk for allograft failure above and beyond eGFR and ACR is unknown. STUDY DESIGN Case-cohort study. SETTING & PARTICIPANTS The FAVORIT (Folic Acid for Vascular Outcome Reduction in Transplantation) Trial was a randomized double-blind trial testing vitamin therapy to lower homocysteine levels in stable kidney transplant recipients. We selected a subset of participants at random (n=491) and all individuals with allograft failure during follow-up (cases; n=257). PREDICTOR Using spot urine specimens from the baseline visit, we measured 4 urinary proteins known to correlate with tubulointerstitial fibrosis on biopsy (urine α 1 -microglobulin [A1M], monocyte chemoattractant protein 1 [MCP-1], and procollagen type III and type I amino-terminal amino pro-peptide). OUTCOME Death-censored allograft failure. RESULTS In models adjusted for demographics, chronic kidney disease risk factors, eGFR, and ACR, higher concentrations of urine A1M (HR per doubling, 1.73; 95% CI, 1.43-2.08) and MCP-1 (HR per doubling, 1.60; 95% CI, 1.32-1.93) were strongly associated with allograft failure. When additionally adjusted for concentrations of other urine fibrosis and several urine injury markers, urine A1M (HR per doubling, 1.76; 95% CI, 1.27-2.44]) and MCP-1 levels (HR per doubling, 1.49; 95% CI, 1.17-1.89) remained associated with allograft failure. Urine procollagen type III and type I levels were not associated with allograft failure. LIMITATIONS We lack kidney biopsy data, BK titers, and HLA antibody status. CONCLUSIONS Urine measurement of tubulointerstitial fibrosis may provide a noninvasive method to identify kidney transplant recipients at higher risk for future allograft failure, above and beyond eGFR and urine ACR.",2017,"CONCLUSIONS Urine measurement of tubulointerstitial fibrosis may provide a noninvasive method to identify kidney transplant recipients at higher risk for future allograft failure, above and beyond eGFR and urine ACR.","['Transplantation', 'Case-cohort study', 'stable kidney transplant recipients', 'kidney transplant recipients', 'participants at random (n=491) and all individuals with allograft failure during follow-up (cases; n=257', 'Kidney Transplant Recipients']","['vitamin therapy', 'FAVORIT (Folic Acid']","['demographics, chronic kidney disease risk factors, eGFR, and ACR, higher concentrations of urine A1M', 'monocyte chemoattractant protein 1 [MCP-1], and procollagen type III and type', 'MCP-1', 'allograft failure', 'MCP-1 levels', 'glomerular filtration rate (eGFR) or urine albumin-creatinine ratio (ACR', 'Urine Fibrosis Markers and Risk of Allograft Failure', 'Urine procollagen type III and type', 'kidney biopsy data, BK titers, and HLA antibody status', 'homocysteine levels', 'Death-censored allograft failure', 'concentrations of other urine fibrosis and several urine injury markers, urine A1M']","[{'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0022671', 'cui_str': 'Grafting, Kidney'}, {'cui': 'C0439605', 'cui_str': 'Random (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0450127', 'cui_str': 'Allogeneic Grafts'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]","[{'cui': 'C0042890', 'cui_str': 'Vitamins'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0016410', 'cui_str': 'Folic Acid'}]","[{'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C1561643', 'cui_str': 'Chronic Kidney Diseases'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0042037'}, {'cui': 'C0128897', 'cui_str': 'Chemokine (C-C Motif) Ligand 2'}, {'cui': 'C0033240', 'cui_str': 'Type III Procollagen'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0450127', 'cui_str': 'Allogeneic Grafts'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0017654', 'cui_str': 'Glomerular Filtration Rate'}, {'cui': 'C3711292', 'cui_str': '68Ga-albumin'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0194073', 'cui_str': 'Kidney biopsy (procedure)'}, {'cui': 'C0475208', 'cui_str': 'TITR'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C2242817', 'cui_str': 'Homocysteine measurement (procedure)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}]",4.0,0.201796,"CONCLUSIONS Urine measurement of tubulointerstitial fibrosis may provide a noninvasive method to identify kidney transplant recipients at higher risk for future allograft failure, above and beyond eGFR and urine ACR.","[{'ForeName': 'Joachim H', 'Initials': 'JH', 'LastName': 'Ix', 'Affiliation': 'Division of Nephrology-Hypertension, Department of Medicine, University of California San Diego, San Diego, CA; Nephrology Section, Veterans Affairs San Diego Healthcare System, San Diego, CA; Division of Preventive Medicine, Department of Family Medicine and Public Health, University of California San Diego, San Diego, CA. Electronic address: joeix@ucsd.edu.'}, {'ForeName': 'Ronit', 'Initials': 'R', 'LastName': 'Katz', 'Affiliation': 'Kidney Research Institute, Division of Nephrology, University of Washington, Seattle, WA.'}, {'ForeName': 'Nisha', 'Initials': 'N', 'LastName': 'Bansal', 'Affiliation': 'Kidney Research Institute, Division of Nephrology, University of Washington, Seattle, WA.'}, {'ForeName': 'Meredith', 'Initials': 'M', 'LastName': 'Foster', 'Affiliation': 'Division of Nephrology, Department of Medicine, Tufts Medical Center, Boston, MA.'}, {'ForeName': 'Daniel E', 'Initials': 'DE', 'LastName': 'Weiner', 'Affiliation': 'Division of Nephrology, Department of Medicine, Tufts Medical Center, Boston, MA.'}, {'ForeName': 'Russell', 'Initials': 'R', 'LastName': 'Tracy', 'Affiliation': 'Department of Pathology, University of Vermont, Burlington, VT.'}, {'ForeName': 'Vasantha', 'Initials': 'V', 'LastName': 'Jotwani', 'Affiliation': 'Division of Nephrology, Department of Medicine, University of California San Francisco, San Francisco, CA.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Hughes-Austin', 'Affiliation': 'Department of Orthopedic Surgery, University of California San Diego, San Diego, CA.'}, {'ForeName': 'Dianne', 'Initials': 'D', 'LastName': 'McKay', 'Affiliation': 'Division of Nephrology-Hypertension, Department of Medicine, University of California San Diego, San Diego, CA.'}, {'ForeName': 'Francis', 'Initials': 'F', 'LastName': 'Gabbai', 'Affiliation': 'Division of Nephrology-Hypertension, Department of Medicine, University of California San Diego, San Diego, CA; Nephrology Section, Veterans Affairs San Diego Healthcare System, San Diego, CA.'}, {'ForeName': 'Chi-Yuan', 'Initials': 'CY', 'LastName': 'Hsu', 'Affiliation': 'Division of Nephrology, Department of Medicine, University of California San Francisco, San Francisco, CA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Bostom', 'Affiliation': 'Rhode Island Hospital, Providence, RI.'}, {'ForeName': 'Andrew S', 'Initials': 'AS', 'LastName': 'Levey', 'Affiliation': 'Division of Nephrology, Department of Medicine, Tufts Medical Center, Boston, MA.'}, {'ForeName': 'Michael G', 'Initials': 'MG', 'LastName': 'Shlipak', 'Affiliation': 'General Internal Medicine Section, San Francisco Veterans Affairs Hospital, San Francisco, CA; Department of Epidemiology and Biostatistics, University of California San Francisco, San Francisco, CA; Division of General Internal Medicine, Department of Medicine, University of California San Francisco, San Francisco, CA.'}]",American journal of kidney diseases : the official journal of the National Kidney Foundation,['10.1053/j.ajkd.2016.10.019'] 1336,28763620,"Acute effects of exercise intensity on subsequent substrate utilisation, appetite, and energy balance in men and women.","Exercise is capable of influencing the regulation of energy balance by acutely modulating appetite and energy intake coupled to effects on substrate utilization. Yet, few studies have examined acute effects of exercise intensity on aspects of both energy intake and energy metabolism, independently of energy cost of exercise. Furthermore, little is known as to the gender differences of these effects. One hour after a standardised breakfast, 40 (19 female), healthy participants (BMI 23.6 ± 3.6 kg·m -2 , V̇O 2peak 34.4 ± 6.8 mL·kg -1 ·min -1 ) undertook either high-intensity intermittent cycling (HIIC) consisting of 8 repeated 60 s bouts of cycling at 95% V̇O 2peak or low-intensity continuous cycling (LICC), equivalent to 50% V̇O 2peak , matched for energy cost (∼950 kJ) followed by 90 mins of rest, in a randomised crossover design. Throughout each study visit, satiety was assessed subjectively using visual analogue scales alongside blood metabolites and GLP-1. Energy expenditure and substrate utilization were measured over 75 min postexercise via indirect calorimetry. Energy intake was assessed for 48 h postintervention. No differences in appetite, GLP-1, or energy intakes were observed between HIIC and LICC, with or without stratifying for gender. Significant differences in postexercise nonesterified fatty acid concentrations were observed between intensities in both genders, coupled to a significantly lower respiratory exchange ratio following HIIC (P = 0.0028), with a trend towards greater reductions in respiratory exchange ratioin males (P = 0.079). In conclusion, high-intensity exercise, if energy matched, does not lead to greater appetite or energy intake, but may exert additional beneficial metabolic effects that may be more pronounced in males.",2017,"Significant differences in postexercise nonesterified fatty acid concentrations were observed between intensities in both genders, coupled to a significantly lower respiratory exchange ratio following HIIC (P = 0.0028), with a trend towards greater reductions in respiratory exchange ratioin males (P = 0.079).",['men and women'],"['exercise intensity', '8 repeated 60 s bouts of cycling at 95% V̇O 2peak or low-intensity continuous cycling (LICC), equivalent to 50% V̇O 2peak , matched for energy cost (∼950 kJ) followed by 90 mins of rest', 'high-intensity intermittent cycling (HIIC']","['Energy intake', 'appetite, GLP-1, or energy intakes', 'respiratory exchange ratioin males', 'postexercise nonesterified fatty acid concentrations', 'subsequent substrate utilisation, appetite, and energy balance', 'Energy expenditure and substrate utilization']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C0596836', 'cui_str': 'Low intensity'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0205267', 'cui_str': 'Intermittent (qualifier value)'}]","[{'cui': 'C0006777', 'cui_str': 'Caloric Intake'}, {'cui': 'C0003618', 'cui_str': 'Appetite'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-Like Peptide 1'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0015688', 'cui_str': 'NEFA'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0014272', 'cui_str': 'Energy Expenditure'}, {'cui': 'C0042153', 'cui_str': 'use'}]",,0.219394,"Significant differences in postexercise nonesterified fatty acid concentrations were observed between intensities in both genders, coupled to a significantly lower respiratory exchange ratio following HIIC (P = 0.0028), with a trend towards greater reductions in respiratory exchange ratioin males (P = 0.079).","[{'ForeName': 'Ghalia', 'Initials': 'G', 'LastName': 'Shamlan', 'Affiliation': 'a Nutritional Sciences, Faculty of Health & Medical Sciences, University of Surrey, Guildford, Surrey, GU2 7XH, United Kingdom.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Bech', 'Affiliation': 'b Department of Diabetes, Endocrinology and Metabolism, Imperial College London, Hammersmith Hospital, London W12 0NN, United Kingdom.'}, {'ForeName': 'M Denise', 'Initials': 'MD', 'LastName': 'Robertson', 'Affiliation': 'a Nutritional Sciences, Faculty of Health & Medical Sciences, University of Surrey, Guildford, Surrey, GU2 7XH, United Kingdom.'}, {'ForeName': 'Adam L', 'Initials': 'AL', 'LastName': 'Collins', 'Affiliation': 'a Nutritional Sciences, Faculty of Health & Medical Sciences, University of Surrey, Guildford, Surrey, GU2 7XH, United Kingdom.'}]","Applied physiology, nutrition, and metabolism = Physiologie appliquee, nutrition et metabolisme",['10.1139/apnm-2017-0280'] 1337,31591063,"Ramucirumab plus erlotinib in patients with untreated, EGFR-mutated, advanced non-small-cell lung cancer (RELAY): a randomised, double-blind, placebo-controlled, phase 3 trial.","BACKGROUND Dual blockade of the EGFR and VEGF pathways in EGFR-mutated metastatic non-small-cell lung cancer (NSCLC) is supported by preclinical and clinical data, yet the approach is not widely implemented. RELAY assessed erlotinib, an EGFR tyrosine kinase inhibitor (TKI) standard of care, plus ramucirumab, a human IgG1 VEGFR2 antagonist, or placebo in patients with untreated EGFR-mutated metastatic NSCLC. METHODS This is a worldwide, double-blind, phase 3 trial done in 100 hospitals, clinics, and medical centres in 13 countries. Eligible patients were aged 18 years or older (20 years or older in Japan and Taiwan) at the time of study entry, had stage IV NSCLC, with an EGFR exon 19 deletion (ex19del) or exon 21 substitution (Leu858Arg) mutation, an Eastern Cooperative Oncology Group performance status of 0 or 1, and no CNS metastases. We randomly assigned eligible patients in a 1:1 ratio to receive oral erlotinib (150 mg/day) plus either intravenous ramucirumab (10 mg/kg) or matching placebo once every 2 weeks. Randomisation was done by an interactive web response system with a computer-generated sequence and stratified by sex, geographical region, EGFR mutation type, and EGFR testing method. The primary endpoint was investigator-assessed progression-free survival in the intention-to-treat population. Safety was assessed in all patients who received at least one dose of study treatment. This trial is registered at ClinicalTrials.gov, NCT02411448, and is ongoing for long-term survival follow-up. FINDINGS Between Jan 28, 2016, and Feb 1, 2018, 449 eligible patients were enrolled and randomly assigned to treatment with ramucirumab plus erlotinib (n=224) or placebo plus erlotinib (n=225). Median duration of follow-up was 20·7 months (IQR 15·8-27·2). At the time of primary analysis, progression-free survival was significantly longer in the ramucirumab plus erlotinib group (19·4 months [95% CI 15·4-21·6]) than in the placebo plus erlotinib group (12·4 months [11·0-13·5]), with a stratified hazard ratio of 0·59 (95% CI 0·46-0·76; p<0·0001). Grade 3-4 treatment-emergent adverse events were reported in 159 (72%) of 221 patients in the ramucirumab plus erlotinib group versus 121 (54%) of 225 in the placebo plus erlotinib group. The most common grade 3-4 treatment-emergent adverse events in the ramucirumab plus erlotinib group were hypertension (52 [24%]; grade 3 only) and dermatitis acneiform (33 [15%]), and in the placebo plus erlotinib group were dermatitis acneiform (20 [9%]) and increased alanine aminotransferase (17 [8%]). Treatment-emergent serious adverse events were reported in 65 (29%) of 221 patients in the ramucirumab plus erlotinib group and 47 (21%) of 225 in the placebo plus erlotinib group. The most common serious adverse events of any grade in the ramucirumab plus erlotinib group were pneumonia (seven [3%]) and cellulitis and pneumothorax (four [2%], each); the most common in the placebo plus erlotinib group were pyrexia (four [2%]) and pneumothorax (three [1%]). One on-study treatment-related death due to an adverse event occurred (haemothorax after a thoracic drainage procedure for a pleural empyema) in the ramucirumab plus erlotinib group. INTERPRETATION Ramucirumab plus erlotinib demonstrated superior progression-free survival compared with placebo plus erlotinib in patients with untreated EGFR-mutated metastatic NSCLC. Safety was consistent with the safety profiles of the individual compounds in advanced lung cancer. The RELAY regimen is a viable new treatment option for the initial treatment of EGFR-mutated metastatic NSCLC. FUNDING Eli Lilly.",2019,Grade 3-4 treatment-emergent adverse events were reported in 159 (72%) of 221 patients in the ramucirumab plus erlotinib group versus 121 (54%) of 225 in the placebo plus erlotinib group.,"['Eligible patients were aged 18 years or older (20 years or older in Japan and Taiwan) at the time of study entry, had stage IV NSCLC, with an EGFR exon 19 deletion (ex19del) or exon 21 substitution (Leu858Arg) mutation, an Eastern Cooperative Oncology Group performance status of 0 or 1, and no CNS metastases', 'patients with untreated, EGFR-mutated, advanced non-small-cell lung cancer (RELAY', 'Between Jan 28, 2016, and Feb 1, 2018, 449 eligible patients', '100 hospitals, clinics, and medical centres in 13 countries', 'advanced lung cancer', 'patients with untreated EGFR-mutated metastatic NSCLC']","['ramucirumab plus erlotinib', 'matching placebo', 'Ramucirumab plus erlotinib', 'placebo', 'placebo plus erlotinib', 'oral erlotinib', 'intravenous ramucirumab']","['pneumothorax', 'Grade 3-4 treatment-emergent adverse events', 'investigator-assessed progression-free survival', 'cellulitis and pneumothorax', 'Safety', 'progression-free survival', 'alanine aminotransferase', 'pyrexia', 'dermatitis acneiform', 'superior progression-free survival', 'hypertension', 'Median duration']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0039260', 'cui_str': 'Formosa'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0441772', 'cui_str': 'Stage level 4 (qualifier value)'}, {'cui': 'C3889117', 'cui_str': 'EGFR exon 19 deletion'}, {'cui': 'C0015295', 'cui_str': 'Exons'}, {'cui': 'C0026882', 'cui_str': 'Mutation'}, {'cui': 'C1520224', 'cui_str': 'Eastern Cooperative Oncology Group performance status'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0565990', 'cui_str': 'Medical center (environment)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C4524268', 'cui_str': 'Advanced lung cancer'}, {'cui': 'C0278987', 'cui_str': 'Metastatic non-small cell lung cancer (disorder)'}]","[{'cui': 'C2742502', 'cui_str': 'ramucirumab'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1135135', 'cui_str': 'erlotinib'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}]","[{'cui': 'C0032326', 'cui_str': 'Pneumothorax'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0035173', 'cui_str': 'Investigators'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0007642', 'cui_str': 'Cellulitis'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0201836', 'cui_str': 'Alanine aminotransferase measurement (procedure)'}, {'cui': 'C0015967', 'cui_str': 'Hyperthermia'}, {'cui': 'C0234894', 'cui_str': 'Dermatitis acneiform'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}]",449.0,0.561056,Grade 3-4 treatment-emergent adverse events were reported in 159 (72%) of 221 patients in the ramucirumab plus erlotinib group versus 121 (54%) of 225 in the placebo plus erlotinib group.,"[{'ForeName': 'Kazuhiko', 'Initials': 'K', 'LastName': 'Nakagawa', 'Affiliation': 'Department of Medical Oncology, Kindai University Faculty of Medicine, Osaka, Japan. Electronic address: nakagawa@med.kindai.ac.jp.'}, {'ForeName': 'Edward B', 'Initials': 'EB', 'LastName': 'Garon', 'Affiliation': 'David Geffen School of Medicine at University of California Los Angeles, Translational Research in Oncology US Network, Los Angeles, CA, USA.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Seto', 'Affiliation': 'National Hospital Organization Kyushu Cancer Center, Fukuoka, Japan.'}, {'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Nishio', 'Affiliation': 'Department of Thoracic Medical Oncology, The Cancer Institute Hospital of the Japanese Foundation for Cancer Research, Tokyo, Japan.'}, {'ForeName': 'Santiago', 'Initials': 'S', 'LastName': 'Ponce Aix', 'Affiliation': 'Hospital Universitario 12 de Octubre, H12O-CNIO Lung Cancer Clinical Research Unit, Universidad Complutense and Ciberonc, Madrid, Spain.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Paz-Ares', 'Affiliation': 'Hospital Universitario 12 de Octubre, H12O-CNIO Lung Cancer Clinical Research Unit, Universidad Complutense and Ciberonc, Madrid, Spain.'}, {'ForeName': 'Chao-Hua', 'Initials': 'CH', 'LastName': 'Chiu', 'Affiliation': 'Department of Chest Medicine, Taipei Veterans General Hospital, Taipei, Taiwan.'}, {'ForeName': 'Keunchil', 'Initials': 'K', 'LastName': 'Park', 'Affiliation': 'Samsung Medical Center, Division of Hematology and Oncology, Sungkyunkwan University School of Medicine, Seoul, South Korea.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Novello', 'Affiliation': 'Department of Oncology, University of Turin, Azienda ospedaliero-universitaria San Luigi, Orbassano, Italy.'}, {'ForeName': 'Ernest', 'Initials': 'E', 'LastName': 'Nadal', 'Affiliation': ""Department of Medical Oncology, Catalan Institute of Oncology, and Clinical Research in Solid Tumors group, Oncobell, l'Institut d'Investigació Biomèdica de Bellvitge, L'Hospitalet, Barcelona, Spain.""}, {'ForeName': 'Fumio', 'Initials': 'F', 'LastName': 'Imamura', 'Affiliation': 'Osaka International Cancer Institute, Osaka, Japan.'}, {'ForeName': 'Kiyotaka', 'Initials': 'K', 'LastName': 'Yoh', 'Affiliation': 'National Cancer Center Hospital East, Kashiwa, Japan.'}, {'ForeName': 'Jin-Yuan', 'Initials': 'JY', 'LastName': 'Shih', 'Affiliation': 'Department of Internal Medicine, National Taiwan University Hospital, Taipei, Taiwan.'}, {'ForeName': 'Kwok Hung', 'Initials': 'KH', 'LastName': 'Au', 'Affiliation': 'Queen Elizabeth Hospital, Kowloon, Hong Kong.'}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Moro-Sibilot', 'Affiliation': 'Grenoble University Hospital, Grenoble, France.'}, {'ForeName': 'Sotaro', 'Initials': 'S', 'LastName': 'Enatsu', 'Affiliation': 'Eli Lilly Japan KK Kobe, Kobe, Japan.'}, {'ForeName': 'Annamaria', 'Initials': 'A', 'LastName': 'Zimmermann', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Bente', 'Initials': 'B', 'LastName': 'Frimodt-Moller', 'Affiliation': 'Eli Lilly and Company, Copenhagen, Denmark.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Visseren-Grul', 'Affiliation': 'Lilly Oncology, Utrecht, Netherlands.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Reck', 'Affiliation': 'LungenClinic, Airway Research Center North, German Center for Lung Research, Grosshansdorf, Germany.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Oncology,['10.1016/S1470-2045(19)30634-5'] 1338,31580931,Effects of stress-induced inflammation on reward processing in healthy young women.,"BACKGROUND Anhedonia, or loss of interest or pleasure, is a feature of depression and transdiagnostic construct in psychopathology. Theory and compelling evidence from preclinical models implicates stress-induced inflammation as a psychobiological pathway to anhedonic behavior; however, this pathway has not been tested in human models. Further, although anhedonia may reflect dysregulation in multiple dimensions of reward, the extent to which stress-induced inflammation alters these dimensions is unclear. Thus, the current experimental study used a standardized laboratory stressor task to elicit an inflammatory response and evaluate effects of stress-induced inflammation on multiple behavioral indices of reward processing. METHODS Healthy young women (age 18-25) completed behavioral reward tasks assessing reward learning, motivation, and sensitivity and were randomized to undergo an acute psychosocial stressor (n = 37) or a no-stress active control (n = 17). Tasks were re-administered 90-120 min post-stress to coincide with the peak of the stress-induced inflammatory response. Blood samples were collected for assessment of the pro-inflammatory cytokine interleukin-6 (IL-6) at baseline and 90 and 120 min post stressor. RESULTS Stress-induced IL-6 was associated with increased response bias during reward learning and increased motivation when probability of receiving a reward was low. Sensitivity to reward in the context of a motivation task was not altered in association with stress-induced IL-6. CONCLUSIONS Contrary to hypotheses, mild increases in IL-6 following acute stress were associated with increased reward responsiveness during reward learning and selective increases in motivation. Results contribute to an emerging and nuanced literature linking inflammation to reward processing, and demonstrate that behavioral effects of stress-induced inflammation may be detected in the laboratory setting. CLINICAL TRIAL REGISTRATION NCT03828604.",2020,"RESULTS Stress-induced IL-6 was associated with increased response bias during reward learning and increased motivation when probability of receiving a reward was low.","['Healthy Young Women', 'Healthy young women (age 18-25) completed']","['Stress-Induced Inflammation', 'behavioral reward tasks assessing reward learning, motivation, and sensitivity and were randomized to undergo an acute psychosocial stressor (n = 37) or a no-stress active control']",['reward responsiveness during reward learning and selective increases in motivation'],"[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]","[{'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0035397', 'cui_str': 'Rewards'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0035397', 'cui_str': 'Rewards'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}]",,0.0614676,"RESULTS Stress-induced IL-6 was associated with increased response bias during reward learning and increased motivation when probability of receiving a reward was low.","[{'ForeName': 'Chloe C', 'Initials': 'CC', 'LastName': 'Boyle', 'Affiliation': 'Norman Cousins Center for Psychoneuroimmunology, Semel Institute for Neuroscience and Behavior, University of California, Los Angeles, CA 90095, United States. Electronic address: ccboyle@ucla.edu.'}, {'ForeName': 'Annette L', 'Initials': 'AL', 'LastName': 'Stanton', 'Affiliation': 'Norman Cousins Center for Psychoneuroimmunology, Semel Institute for Neuroscience and Behavior, University of California, Los Angeles, CA 90095, United States; Department of Psychiatry and Biobehavioral Sciences, University of California, Los Angeles, CA 90095, United States; Department of Psychology, University of California, Los Angeles, CA 90095, United States.'}, {'ForeName': 'Naomi I', 'Initials': 'NI', 'LastName': 'Eisenberger', 'Affiliation': 'Department of Psychology, University of California, Los Angeles, CA 90095, United States.'}, {'ForeName': 'Teresa E', 'Initials': 'TE', 'LastName': 'Seeman', 'Affiliation': 'Geffen School of Medicine, University of California, Los Angeles, CA 90095, United States.'}, {'ForeName': 'Julienne E', 'Initials': 'JE', 'LastName': 'Bower', 'Affiliation': 'Norman Cousins Center for Psychoneuroimmunology, Semel Institute for Neuroscience and Behavior, University of California, Los Angeles, CA 90095, United States; Department of Psychiatry and Biobehavioral Sciences, University of California, Los Angeles, CA 90095, United States; Department of Psychology, University of California, Los Angeles, CA 90095, United States.'}]","Brain, behavior, and immunity",['10.1016/j.bbi.2019.09.023'] 1339,31567611,Pooled Subject-Reported Outcomes From 2 Phase 3 Studies of OnabotulinumtoxinA for Simultaneous Treatment of Forehead and Glabellar Lines.,"BACKGROUND Understanding the subjects' perspective is critical for successfully treating upper facial lines. OBJECTIVE To understand subjects' self-perception and overall satisfaction after onabotulinumtoxinA treatment for forehead and glabellar lines. METHODS This analysis pooled data from two 12-month, pivotal phase 3 studies in which toxin-naive subjects received onabotulinumtoxinA 40 U or placebo for treatment of upper facial lines. OnabotulinumtoxinA was administered as 0.1-mL injections at 10 prespecified sites (frontalis: 20 U; glabellar complex: 20 U). Each study used 3 reliable and validated patient-reported outcome instruments to evaluate subject satisfaction and appearance-related psychological effects: the Facial Line Satisfaction Questionnaire (FLSQ), the Facial Line Outcomes (FLO-11) Questionnaire, and the Self-Perception of Age (SPA) Questionnaire. In total, data for 865 subjects (608, onabotulinumtoxinA 40 U; 257, placebo) were analyzed. RESULTS Treatment with onabotulinumtoxinA 40 U resulted in significant and sustained improvements across all pooled FLO-11 items and FLSQ items compared with placebo. SPA results demonstrated that a significant proportion of subjects in the pooled analysis felt they looked younger after treatment than at baseline (all, p < .0001 vs placebo). CONCLUSION This study demonstrates a high level of treatment satisfaction and significantly improved appearance-related psychological outcomes among toxin-naive subjects after onabotulinumtoxinA 40 U treatment.",2020,"RESULTS Treatment with onabotulinumtoxinA 40 U resulted in significant and sustained improvements across all pooled FLO-11 items and FLSQ items compared with placebo.","['toxin-naive subjects after onabotulinumtoxinA 40 U treatment', '865 subjects (608, onabotulinumtoxinA 40 U; 257']","['placebo', 'onabotulinumtoxinA 40 U or placebo', 'OnabotulinumtoxinA']","['appearance-related psychological outcomes', 'Facial Line Satisfaction Questionnaire (FLSQ), the Facial Line Outcomes (FLO-11) Questionnaire, and the Self-Perception of Age (SPA) Questionnaire']","[{'cui': 'C4522020', 'cui_str': 'Toxin'}, {'cui': 'C2719767', 'cui_str': 'onabotulinumtoxinA'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2719767', 'cui_str': 'onabotulinumtoxinA'}]","[{'cui': 'C0700364', 'cui_str': 'Appearances (qualifier value)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0242498', 'cui_str': 'Self-Perception'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]",865.0,0.14096,"RESULTS Treatment with onabotulinumtoxinA 40 U resulted in significant and sustained improvements across all pooled FLO-11 items and FLSQ items compared with placebo.","[{'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Ogilvie', 'Affiliation': 'Skin Concept, Munich, Germany.'}, {'ForeName': 'Alexander Z', 'Initials': 'AZ', 'LastName': 'Rivkin', 'Affiliation': 'David Geffen School of Medicine, UCLA, Los Angeles, California.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Dayan', 'Affiliation': 'DeNova Research, Chicago, Illinois.'}, {'ForeName': 'Steven G', 'Initials': 'SG', 'LastName': 'Yoelin', 'Affiliation': 'Medical Associates Inc., Newport Beach, California.'}, {'ForeName': 'Kristin E', 'Initials': 'KE', 'LastName': 'Larsen', 'Affiliation': 'Peloton Advantage, Parsippany, New Jersey.'}, {'ForeName': 'Sepideh', 'Initials': 'S', 'LastName': 'Varon', 'Affiliation': 'Health Economics and Outcomes Research, Allergan plc, Irvine, California.'}, {'ForeName': 'Julie K', 'Initials': 'JK', 'LastName': 'Garcia', 'Affiliation': 'Health Economics and Outcomes Research, Allergan plc, Irvine, California.'}]",Dermatologic surgery : official publication for American Society for Dermatologic Surgery [et al.],['10.1097/DSS.0000000000002153'] 1340,27805473,Are Disease Awareness Links on Prescription Drug Websites Misleading? A Randomized Study.,"We sought to determine whether links from branded prescription drug websites to websites containing disease information mislead participants about drug benefits and whether nonsponsorship disclosures diminish this potential effect. We randomly assigned online panelists with depression (N = 1,071) to view a fictitious prescription drug website that had (a) no link to a disease information website (control), (b) a link with no disclosure, (c) a link with a simple nonsponsorship disclosure, or (d) a link with a detailed nonsponsorship disclosure. If participants in the link conditions did not click the link, they were returned to the drug website and encouraged to click it. All participants then completed an online questionnaire assessing recall, perceptions, and intentions. Few participants (12%) clicked the link without prompting; 67% did so when prompted. Compared with control participants, participants in link conditions were more likely to confuse disease information with drug benefits and to recall fewer true drug benefits. Disclosures did not diminish these effects, and exposure to disease information did not affect other perceptions or intentions. Consumers seem to confuse information on disease websites with information on branded prescription drug websites. Disclosures may not adequately help consumers to distinguish between the 2 types of information.",2016,"Compared with control participants, participants in link conditions were more likely to confuse disease information with drug benefits and to recall fewer true drug benefits.",[],"['online panelists with depression (N\xa0=\xa01,071) to view a fictitious prescription drug website that had (a) no link to a disease information website (control']",[],[],"[{'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0449911', 'cui_str': 'View (attribute)'}, {'cui': 'C0304227', 'cui_str': 'Prescription Drugs'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]",[],,0.0526322,"Compared with control participants, participants in link conditions were more likely to confuse disease information with drug benefits and to recall fewer true drug benefits.","[{'ForeName': 'Helen W', 'Initials': 'HW', 'LastName': 'Sullivan', 'Affiliation': 'a Office of Prescription Drug Promotion, Center for Drug Evaluation and Research, U.S. Food and Drug Administration , Silver Spring , Maryland , USA.'}, {'ForeName': 'Amie C', 'Initials': 'AC', 'LastName': ""O'Donoghue"", 'Affiliation': 'a Office of Prescription Drug Promotion, Center for Drug Evaluation and Research, U.S. Food and Drug Administration , Silver Spring , Maryland , USA.'}, {'ForeName': 'Douglas J', 'Initials': 'DJ', 'LastName': 'Rupert', 'Affiliation': 'b RTI International , Research Triangle Park , North Carolina , USA.'}, {'ForeName': 'Jessica Fitts', 'Initials': 'JF', 'LastName': 'Willoughby', 'Affiliation': 'c Edward R. Murrow College of Communication, Washington State University , Pullman , Washington , USA.'}, {'ForeName': 'Jacqueline B', 'Initials': 'JB', 'LastName': 'Amoozegar', 'Affiliation': 'b RTI International , Research Triangle Park , North Carolina , USA.'}, {'ForeName': 'Kathryn J', 'Initials': 'KJ', 'LastName': 'Aikin', 'Affiliation': 'a Office of Prescription Drug Promotion, Center for Drug Evaluation and Research, U.S. Food and Drug Administration , Silver Spring , Maryland , USA.'}]",Journal of health communication,[] 1341,32414425,Temporary interruption of baricitinib: characterization of interruptions and effect on clinical outcomes in patients with rheumatoid arthritis.,"BACKGROUND In clinical practice, temporary interruption of rheumatoid arthritis (RA) therapy is common for various reasons including side effects, non-compliance, or necessity for surgery. To characterize temporary interruptions of baricitinib and placebo-matched tablets in phase 3 studies of patients with moderate-to-severe rheumatoid arthritis (RA) and describe their impact on efficacy and safety. METHODS During 4 baricitinib phase 3 studies, investigators documented timing, reason, and duration of investigator-initiated temporary interruptions of study drug. In 2 studies, patients recorded RA symptoms in daily diaries for 12 weeks. Post hoc analyses investigated changes in symptom scores during interruptions and resumption of treatment. Interruptions were evaluated for reoccurrence of adverse events or laboratory abnormalities after retreatment. RESULTS Across the placebo-controlled studies, interruptions occurred in larger proportions of baricitinib- (2 mg, 18%; 4 mg, 18%) vs placebo-treated (9%) patients in only one study (bDMARD-inadequate responder patients, RA-BEACON). In the active comparator-controlled studies, the lowest rates of interruption were in the baricitinib monotherapy arm (9%) of RA-BEGIN (vs methotrexate monotherapy or combination therapy), and proportions were similar for baricitinib (10%) and adalimumab (9%) in RA-BEAM. Adverse events were the most common reason for interruption, but their reoccurrence after drug restart was infrequent. Most interruptions lasted ≤ 2 weeks. Daily diaries indicated modest symptom increases during interruption with return to pre-interruption levels or better after resumption. Interruptions had no impact on long-term efficacy outcomes. CONCLUSIONS Consistent with its pharmacologic properties, brief interruptions of baricitinib during phase 3 studies were associated with minor increases in RA symptoms that resolved following retreatment. This analysis provides useful information for clinicians, as temporary interruption of antirheumatic therapy is common in the care of patients with RA. TRIAL REGISTRATION ClinicalTrials.gov; NCT01710358, NCT01711359, NCT01721057, NCT01721044.",2020,"Interruptions had no impact on long-term efficacy outcomes. ","['patients with rheumatoid arthritis', 'patients with moderate-to-severe rheumatoid arthritis (RA', 'patients with RA']","['baricitinib', 'baricitinib and placebo-matched tablets', 'adalimumab']","['Adverse events', 'long-term efficacy outcomes', 'efficacy and safety', 'RA symptoms', 'reoccurrence of adverse events or laboratory abnormalities', 'symptom scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}]","[{'cui': 'C4044947', 'cui_str': 'baricitinib'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C1122087', 'cui_str': 'adalimumab'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0000768', 'cui_str': 'Congenital malformation'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.490948,"Interruptions had no impact on long-term efficacy outcomes. ","[{'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Emery', 'Affiliation': 'Leeds Muscoloskeletal Biomedical Research Centre/Chapel Allerton Hospital, Chapeltown Rd, Leeds, LS7 4SA, UK. P.Emery@leeds.ac.uk.'}, {'ForeName': 'Yoshiya', 'Initials': 'Y', 'LastName': 'Tanaka', 'Affiliation': 'The First Department of Internal Medicine, School of Medicine, University of Occupational and Environmental Health, Kitakyushu, Japan.'}, {'ForeName': 'Tracy', 'Initials': 'T', 'LastName': 'Cardillo', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Schlichting', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Terence', 'Initials': 'T', 'LastName': 'Rooney', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Beattie', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Cameron', 'Initials': 'C', 'LastName': 'Helt', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Josef S', 'Initials': 'JS', 'LastName': 'Smolen', 'Affiliation': 'Division of Rheumatology, Department of Medicine 3, Medical University of Vienna, Vienna, Austria.'}]",Arthritis research & therapy,['10.1186/s13075-020-02199-8'] 1342,31563471,Impact of vascular access on outcome after PCI in patients at high bleeding risk: a pre-specified sub-analysis of the LEADERS FREE trial.,"INTRODUCTION AND OBJECTIVES The prognostic impact of bleeding in high bleeding risk (HBR) patients depending on the location of bleeding and prognosis in nonaccess site bleeding is unknown. We aimed to assess the impact of vascular access site on bleeding complications after percutaneous coronary interventions for HBR patients at 30-day and 2-year follow-up. METHODS The LEADERS FREE trial included 2432 HBR PCI patients. A Biolimus A9 drug-coated stent was superior to a bare-metal stent for safety and efficacy. This is a predefined sub-analysis of the LEADERS FREE trial. RESULTS Transradial access (TRA) was used in 1454 patients (59.8%) and transfemoral access (TFA) in 978 (40.2%), according to operator preference. The safety and benefits of drug-coated stents over bare-metal stents were independent of vascular access. At 30 days and 2 years, major bleeding had occurred in 2.4% and 7.5% of TRA patients and 4.6% and 10.9% of TFA patients (P=.003), respectively. Most of these events in both groups (2.1% and 7.0% for TRA; 3.2% and 9.4% for TFA, respectively) were nonaccess site-related. TRA was associated with a significant reduction in adjusted rates of major bleeding both at 30 days (HR, 1.98; 95%CI, 1.25-3.11; P=.003) and at 2 years of follow-up (HR, 1.51; 95%CI, 1.14-2.01; P=.003). This difference was driven by both access and nonaccess bleeding. CONCLUSIONS Operators preferred TRA for most HBR patients, which was associated with a significant reduction in major bleeding events. However, most of these events in this population are unrelated to vascular access.",2020,"TRA was associated with a significant reduction in adjusted rates of major bleeding both at 30 days (HR, 1.98; 95%CI, 1.25-3.11; P=.003) and at 2 years of follow-up (HR, 1.51; 95%CI, 1.14-2.01; P=.003).","['HBR patients at 30-day and 2-year follow-up', 'patients at high bleeding risk', '2432 HBR PCI patients']","['drug-coated stents', 'TRA']","['adjusted rates of major bleeding', 'major bleeding events', 'major bleeding', 'bleeding complications']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]","[{'cui': 'C1445093', 'cui_str': 'Drug-Coated Stents'}]","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}]",1454.0,0.189449,"TRA was associated with a significant reduction in adjusted rates of major bleeding both at 30 days (HR, 1.98; 95%CI, 1.25-3.11; P=.003) and at 2 years of follow-up (HR, 1.51; 95%CI, 1.14-2.01; P=.003).","[{'ForeName': 'Víctor Alfonso', 'Initials': 'VA', 'LastName': 'Jiménez Díaz', 'Affiliation': 'Departamento de Cardiología, Hospital Álvaro Cunqueiro, Hospital Universitario de Vigo, Vigo, Pontevedra, Spain.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Hovasse', 'Affiliation': 'Cardiology Department, Hôpital Privé Jacques Cartier, Massy, France.'}, {'ForeName': 'Andrés', 'Initials': 'A', 'LastName': 'Íñiguez', 'Affiliation': 'Departamento de Cardiología, Hospital Álvaro Cunqueiro, Hospital Universitario de Vigo, Vigo, Pontevedra, Spain.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Copt', 'Affiliation': 'Biosensors Europe, Morges, Switzerland.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Byrne', 'Affiliation': ""Cardiology Department, King's College, London, United Kingdom.""}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Brunel', 'Affiliation': 'Cardiology Department, Clinique de Fontaine, Nantes, France.'}, {'ForeName': 'Marie-Claude', 'Initials': 'MC', 'LastName': 'Morice', 'Affiliation': 'Cardiology Department, ICPS, Générale de Santé, Massy, France.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Abizaid', 'Affiliation': 'Cardiology Department, Instituto Dante Pazzanese de Cardiologia, São Paulo, Brazil.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Tespilli', 'Affiliation': 'Cardiology Department, Ospedale Bolognini, Seriate-Bergamo, Italy.'}, {'ForeName': 'Darren', 'Initials': 'D', 'LastName': 'Walters', 'Affiliation': 'Cardiology Department, Prince Charles Hospital, Queensland, Australia.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Ortiz Sáez', 'Affiliation': 'Departamento de Cardiología, Hospital Álvaro Cunqueiro, Hospital Universitario de Vigo, Vigo, Pontevedra, Spain.'}, {'ForeName': 'Guillermo', 'Initials': 'G', 'LastName': 'Bastos Fernández', 'Affiliation': 'Departamento de Cardiología, Hospital Álvaro Cunqueiro, Hospital Universitario de Vigo, Vigo, Pontevedra, Spain.'}, {'ForeName': 'Hans-Peter', 'Initials': 'HP', 'LastName': 'Stoll', 'Affiliation': 'Biosensors Europe, Morges, Switzerland.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Urban', 'Affiliation': 'Cardiology Department, Hôpital de la Tour, Geneva, Switzerland. Electronic address: philip.urban@latour.ch.'}]",Revista espanola de cardiologia (English ed.),['10.1016/j.rec.2019.07.010'] 1343,32416157,Effects of high and low sucrose-containing beverages on blood glucose and hypoglycemic-like symptoms.,"BACKGROUND AND AIMS There is this intriguing but not yet well-explored suggestion that highly absorbable sucrose-sweetened drinks might exacerbate hunger by promoting temporal hypoglycemia-like responses already in non-diabetic healthy individuals. This might provide a possible additional explanatory mechanism for previous reported associations between consumption of sugar-sweetened drinks and body weight gain. The current study involves two separate and independently conducted human experiments exploring the effects of two different single-doses of sugar-sweetened beverages on temporal blood glucose nadir and possible related behavioral hypoglycemic-like symptoms in healthy participants. METHODS By way of two separately conducted between-subjects experiments, effects of 1) a low (29 g) sugar-containing beverage compared to a sweetened zero-energy drink and a milk drink (experiment-1) or 2) a high (80 g) sugar-sweetened beverage compared to a zero-energy and a non-sweetened colored water drink (experiment-2) were measured on changes in blood glucose, behavioral hypoglycemia, appetite and mood. RESULTS Experiment-1: The 29 g sucrose containing beverage caused a high (37%) glycemic increase and a smaller response (15%) to the milk drink, which both peaked 30 min after consumption, whereas the sweetened zero-energy drink had very little effect on blood glucose. Regardless of the different magnitude of peak glycemic responses, both the sugar and milk drinks rather equally caused blood glucose concentrations to return to normal and stable baseline values 90 min later. There were no (different) effects of the beverages on behavioral hypoglycemic-like symptoms, appetite or mood. Experiment-2: the 80 g sucrose containing beverage caused a large (72%) glycemic peak response at +30 min after consumption, whereas neither the sweetened zero-energy nor the non-sweetened colored water drink had any meaningful effect on blood glucose. After intake of the 80 g sugar beverage, blood glucose concentrations remained elevated (13%) at +120 min and returned to lower baseline values in the direction of hypoglycemia levels at +165 min. There were no (differential) effects of the beverages on behavioral hypoglycemic symptoms, appetite or mood. CONCLUSIONS The current findings indicate that instead of a low (29 g) sugar-containing beverage, a high (80 g) sugar-containing beverage caused blood glucose concentrations to fall below baseline values almost reaching hypoglycemia levels at the end of measurements. There were no hypoglycemic-like behavioral symptoms including changes in appetite or mood: at least not at end of measurements +165 min after consumption. Since this might include that in particular consumption of high-glycemic index drinks could still promote symptoms in the longer run, further research is needed to explore possible hypoglycemic-like effects of high dosages of sugar-sweetened beverages across more extended/delayed time measurements.",2020,There were no hypoglycemic-like behavioral symptoms including changes in appetite or mood: at least not at end of measurements +165min after consumption.,"['healthy participants', 'Experiment-1', 'Experiment-2']","['high and low sucrose-containing beverages', 'low (29g) sugar-containing beverage compared to a sweetened zero-energy drink and a milk drink (experiment-1) or 2) a high (80g) sugar-sweetened beverage compared to a zero-energy and a non-sweetened colored water drink (experiment-2', 'sugar-sweetened beverages']","['blood glucose, behavioral hypoglycemia, appetite and mood', 'behavioral hypoglycemic-like symptoms, appetite or mood', 'blood glucose', 'glycemic peak response', 'blood glucose and hypoglycemic-like symptoms', 'hypoglycemic-like behavioral symptoms including changes in appetite or mood', 'blood glucose concentrations', 'behavioral hypoglycemic symptoms, appetite or mood', 'temporal blood glucose nadir']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0038636', 'cui_str': 'Sucrose'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0001967', 'cui_str': 'Alcoholic beverage'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0919414', 'cui_str': '0'}, {'cui': 'C3179078', 'cui_str': 'Energy drink'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C5197754', 'cui_str': 'Sugar-Added Beverages'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}]","[{'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0020616', 'cui_str': 'Hypoglycemic agent'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0004941', 'cui_str': 'Behavioral Symptoms'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0426587', 'cui_str': 'Altered appetite'}, {'cui': 'C2585282', 'cui_str': 'Blood glucose concentration'}, {'cui': 'C0442043', 'cui_str': 'Temporal'}]",,0.0416675,There were no hypoglycemic-like behavioral symptoms including changes in appetite or mood: at least not at end of measurements +165min after consumption.,"[{'ForeName': 'C Rob', 'Initials': 'CR', 'LastName': 'Markus', 'Affiliation': 'University Maastricht, Faculty of Psychology and Neuroscience; Dept of Neuropsychology & Psychopharmacology, Maastricht, Netherlands.. Electronic address: r.markus@maastrichtuniversity.nl.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Rogers', 'Affiliation': 'Nutrition and Behaviour Unit, School of Psychological Science, University of Bristol, Bristol, UK.'}]",Physiology & behavior,['10.1016/j.physbeh.2020.112916'] 1344,32416251,Time course and management of key adverse events during the randomized phase III SOLAR-1 study of PI3K inhibitor alpelisib plus fulvestrant in patients with HR-positive advanced breast cancer.,"BACKGROUND Alpelisib (α-selective phosphatidylinositol 3-kinase inhibitor) plus fulvestrant is approved in multiple countries for men and postmenopausal women with PIK3CA-mutated, hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer following progression on or after endocrine therapy. A detailed understanding of alpelisib's safety profile should inform adverse event (AE) management and enhance patient care. PATIENTS AND METHODS AEs in the phase III SOLAR-1 trial were assessed in patients with and without PIK3CA mutations. The impact of protocol-specified AE-management recommendations was evaluated, including an amendment to optimize hyperglycemia and rash management. RESULTS Patients were randomly assigned to receive fulvestrant plus alpelisib (n = 284) or placebo (n = 287). The most common grade 3/4 AEs with alpelisib were hyperglycemia (grade 3, 32.7%; grade 4, 3.9%), rash (grade 3, 9.9%), and diarrhea (grade 3, 6.7%). Median time to onset of grade ≥3 toxicity was 15 days (hyperglycemia, based on fasting plasma glucose), 13 days (rash), and 139 days (diarrhea). Metformin alone or in combination with other antidiabetic agents was used by most patients (87.1%) with hyperglycemia. Preventive anti-rash medication resulted in lower incidence (any grade, 26.7% versus 64.1%) and severity of rash (grade 3, 11.6% versus 22.7%) versus no preventative medication. Discontinuations due to grade ≥3 AEs were lower following more-detailed AE management guidelines (7.9% versus 18.1% previously). Patients with PIK3CA mutations had a median alpelisib dose intensity of 248 mg/day. Median progression-free survival with alpelisib was 12.5 and 9.6 months for alpelisib dose intensities of ≥248 mg/day and <248 mg/day, respectively, compared with 5.8 months with placebo. CONCLUSIONS Hyperglycemia and rash occurred early during alpelisib treatment, while diarrhea occurred at a later time point. Early identification, prevention, and intervention, including concomitant medications and alpelisib dose modifications, resulted in less severe toxicities. Reductions in treatment discontinuations and improved progression-free survival at higher alpelisib dose intensities support the need for optimal AE management. CLINICALTRIALS. GOV ID NCT02437318.",2020,"Preventive anti-rash medication resulted in lower incidence (any grade, 26.7% vs 64.1%) and severity of rash (grade 3, 11.6% vs 22.7%) vs no preventative medication.","['Patients With HR-Positive Advanced Breast Cancer', 'AEs in the phase 3 SOLAR-1 trial were assessed in patients with and without PIK3CA mutations', 'multiple countries for men and post-menopausal women with PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer following progression on or after endocrine therapy']","['Metformin', 'Alpelisib (α-selective PI3K inhibitor) plus fulvestrant', 'fulvestrant plus alpelisib', 'PI3K Inhibitor Alpelisib Plus Fulvestrant', 'placebo']","['diarrhea', 'median alpelisib dose intensity', 'PFS', 'Hyperglycemia and rash', 'Time Course and Management of Key Adverse Events', 'Median time to onset of grade ≥3 toxicity', 'Median progression-free survival (PFS', 'rash', 'severe toxicities', 'hyperglycemia', 'severity of rash']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C3495917', 'cui_str': 'Advanced breast cancer'}, {'cui': 'C0282461', 'cui_str': 'Clinical Trials, Phase 3 as Topic'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1451005', 'cui_str': 'PIK3CA protein, human'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0242957', 'cui_str': 'Genes, erbb2'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy'}]","[{'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C4055478', 'cui_str': 'alpelisib'}, {'cui': 'C0044602', 'cui_str': '1-phosphatidylinositol 3-kinase'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0935916', 'cui_str': 'fulvestrant'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C4055478', 'cui_str': 'alpelisib'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}, {'cui': 'C0449247', 'cui_str': 'Time course'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332162', 'cui_str': 'Onset of'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",,0.111823,"Preventive anti-rash medication resulted in lower incidence (any grade, 26.7% vs 64.1%) and severity of rash (grade 3, 11.6% vs 22.7%) vs no preventative medication.","[{'ForeName': 'H S', 'Initials': 'HS', 'LastName': 'Rugo', 'Affiliation': 'Department of Medicine, Division of Hematology and Oncology, University of California San Francisco Helen Diller Family Comprehensive Cancer Center, San Francisco, USA. Electronic address: Hope.Rugo@ucsf.edu.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'André', 'Affiliation': 'Department of Medical Oncology, INSERM U981, Gustave Roussy, Université Paris-Sud, Villejuif, France.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Yamashita', 'Affiliation': 'Department of Breast and Endocrine Surgery, Kanagawa Cancer Center Hospital, Yokohama, Japan.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Cerda', 'Affiliation': 'Clinica RedSalud Vitacura, Santiago, Chile.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Toledano', 'Affiliation': 'Institut Curie, Paris, France.'}, {'ForeName': 'S M', 'Initials': 'SM', 'LastName': 'Stemmer', 'Affiliation': 'Institute of Oncology, Davidoff Center, Rabin Medical Center, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'J C', 'Initials': 'JC', 'LastName': 'Jurado', 'Affiliation': 'Hospital Universitario Canarias, S/C Tenerife, Islas Canarias, Spain.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Juric', 'Affiliation': 'Department of Medicine, Massachusetts General Hospital Cancer Center, Boston, USA.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Mayer', 'Affiliation': 'Department of Medicine, Hematology and Oncology, Vanderbilt University, Nashville, USA.'}, {'ForeName': 'E M', 'Initials': 'EM', 'LastName': 'Ciruelos', 'Affiliation': 'Medical Oncology Department, Breast Cancer Unit, Hospital Universitario 12 de Octubre, Madrid, Spain.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Iwata', 'Affiliation': 'Department of Breast Oncology, Aichi Cancer Center Hospital, Nagoya, Japan.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Conte', 'Affiliation': 'Department of Surgery, Oncology and Gastroenterology, University of Padua and Medical Oncology 2, Istituto Oncologico Veneto, IRCCS, Padua, Italy.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Campone', 'Affiliation': ""Department of Medical Oncology, Institut de Cancérologie de l'Ouest, St Herblain, France.""}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Wilke', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Mills', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Lteif', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Miller', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, USA.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Gaudenzi', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Loibl', 'Affiliation': 'Department of Medicine and Research, German Breast Group, Neu-Isenburg; Centre for Haematology and Oncology Bethanien, Frankfurt, Germany.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1016/j.annonc.2020.05.001'] 1345,30349039,The impact of counseling on nutritional status among hematopoietic stem cell recipients: results of a randomized controlled trial.,,2019,,['hematopoietic stem cell recipients'],[],[],"[{'cui': 'C0018956', 'cui_str': 'Progenitor Cells, Hematopoietic'}]",[],[],,0.0591251,,"[{'ForeName': 'Jana', 'Initials': 'J', 'LastName': 'Jabbour', 'Affiliation': 'Department of Clinical Nutrition, American University of Beirut Medical Center, Beirut, Lebanon.'}, {'ForeName': 'Batoul', 'Initials': 'B', 'LastName': 'Manana', 'Affiliation': 'Division of Hematology/Oncology, Department of Internal Medicine, American University of Beirut Medical Center, Beirut, Lebanon.'}, {'ForeName': 'May', 'Initials': 'M', 'LastName': 'Sakr', 'Affiliation': 'Department of Clinical Nutrition, American University of Beirut Medical Center, Beirut, Lebanon.'}, {'ForeName': 'Ammar', 'Initials': 'A', 'LastName': 'Zahreddine', 'Affiliation': 'Bone Marrow Transplantation Program, Department of Internal Medicine, American University of Beirut Medical Center, Beirut, Lebanon.'}, {'ForeName': 'Hani', 'Initials': 'H', 'LastName': 'Tamim', 'Affiliation': 'Clinical Research Unit, American University of Beirut of Medical Center, Beirut, Lebanon.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Bazarbachi', 'Affiliation': 'Bone Marrow Transplantation Program, Department of Internal Medicine, American University of Beirut Medical Center, Beirut, Lebanon.'}, {'ForeName': 'Didier', 'Initials': 'D', 'LastName': 'Blaise', 'Affiliation': 'Ecole Doctorale Sciences de la Vie et de la Santé, Aix Marseille Université, Marseille, France.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'El-Cheikh', 'Affiliation': 'Bone Marrow Transplantation Program, Department of Internal Medicine, American University of Beirut Medical Center, Beirut, Lebanon. je46@aub.edu.lb.'}]",Bone marrow transplantation,['10.1038/s41409-018-0366-3'] 1346,29037793,Transcranial direct current stimulation of the rLPFC shifts normative judgments in voluntary cooperation.,"Normative judgment is a key capacity for human social norm compliance. Previous studies have revealed that the right lateral prefrontal cortex (rLPFC) is closely related to social norm compliance and that it has proven stimulation effects on behavior in voluntary and sanction-induced norm compliance, but not normative judgments. Nearly all these studies have been based on sanction-induced coordination cooperation, and a number of them have found that rLPFC has no effect on normative judgment with transcranial direct current stimulation (tDCS). However, no research study exists regarding the effects of the normative judgment in voluntary cooperation. In this study, we used a linear asymmetric public good game to investigate the role of normative judgment in voluntary cooperation with tDCS on rLPFC. Participants were engaged in anonymous social interactions and made decisions with real financial consequences after being randomly assigned to receive either anodal, cathodal, or sham stimulation of 15 min. Results suggest that compared with the sham group, anodal/cathodal tDCS influenced the behavior and normative judgment of participants in opposite directions. These outcomes provide a neural evidence for the rLPFC mechanism on normative judgment in voluntary cooperation.",2020,"Participants were engaged in anonymous social interactions and made decisions with real financial consequences after being randomly assigned to receive either anodal, cathodal, or sham stimulation of 15min.",[],"['anodal/cathodal tDCS', 'anodal, cathodal, or sham stimulation of 15min']",[],[],"[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}]",[],,0.0211668,"Participants were engaged in anonymous social interactions and made decisions with real financial consequences after being randomly assigned to receive either anodal, cathodal, or sham stimulation of 15min.","[{'ForeName': 'Xiaoli', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'China Academy of Corporate Governance, Nankai University, PR China; Reinhard Selten Laboratory, Nankai University, Tianjin, PR China; Collaborative Innovation Center for China Economy, PR China.'}, {'ForeName': 'Jianbiao', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'China Academy of Corporate Governance, Nankai University, PR China; Reinhard Selten Laboratory, Nankai University, Tianjin, PR China; Collaborative Innovation Center for China Economy, PR China. Electronic address: biaojl@126.com.'}, {'ForeName': 'Guangrong', 'Initials': 'G', 'LastName': 'Wang', 'Affiliation': 'Neural Decision Science Laboratory, Weifang University, PR China.'}, {'ForeName': 'Xile', 'Initials': 'X', 'LastName': 'Yin', 'Affiliation': 'China Academy of Corporate Governance, Nankai University, PR China; Reinhard Selten Laboratory, Nankai University, Tianjin, PR China; Collaborative Innovation Center for China Economy, PR China.'}, {'ForeName': 'Shuaiqi', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'China Academy of Corporate Governance, Nankai University, PR China; Reinhard Selten Laboratory, Nankai University, Tianjin, PR China; Collaborative Innovation Center for China Economy, PR China.'}, {'ForeName': 'Xiaogai', 'Initials': 'X', 'LastName': 'Fu', 'Affiliation': 'China Academy of Corporate Governance, Nankai University, PR China; Reinhard Selten Laboratory, Nankai University, Tianjin, PR China; Collaborative Innovation Center for China Economy, PR China.'}]",Neuroscience letters,['10.1016/j.neulet.2017.10.020'] 1347,31590139,Measuring the effects on quality of life and alcohol consumption of a program to reduce binge drinking in Spanish adolescents.,"AIM To present a comparison between the effects on health due to a reduction in binge drinking (BD) and health-related quality of life (HRQoL), as a result of ALERTA ALCOHOL, an intervention aimed at reducing BD in Spanish adolescents. METHODS A two-arm cluster randomized controlled trial was conducted with an intervention and a control group, randomized at the school level, following individuals over four months. The study population consisted of Andalusian adolescents aged 15 to 19 years who were enrolled in urban public high schools (n = 1247). Participants were assigned randomly to receive the intervention. The main outcomes studied were the number of occasions of BD in the last 30 days, which was directly obtained from the answers given by the adolescents, and HRQoL measured with the EQ-5D-5 L questionnaire. The model of estimation was the generalized estimating equations (GEE) approach. RESULTS The program showed a BD reduction at the 4-month follow-up, although it was not shown to significantly increase the HRQoL in adolescents who reduced the number of occasions of BD and had received the intervention. However, it was shown that those who would predictably reduce the number of occasions of BD controlled by several sociodemographic variables perceived a higher HRQoL, as did those who had a greater adherence to the program. CONCLUSIONS Higher adherence to a web-based computer-tailored intervention to prevent BD in adolescents has a positive effect on decreasing the number of occasions of BD in adolescents as well as on increasing participants' HRQoL, although this second effect is very small, which could be due to the short follow-up time. This fact is quite important and should be assessed extensively to corroborate the results and translate into health policy.",2019,"The program showed a BD reduction at the 4-month follow-up, although it was not shown to significantly increase the HRQoL in adolescents who reduced the number of occasions of BD and had received the intervention.","['Spanish adolescents', 'Andalusian adolescents aged 15 to 19 years who were enrolled in urban public high schools (n\u202f=\u202f1247']",[],"['HRQoL', 'quality of life and alcohol consumption', 'binge drinking (BD) and health-related quality of life (HRQoL', 'number of occasions of BD']","[{'cui': 'C3161473', 'cui_str': 'Spaniards (ethnic group)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0036375', 'cui_str': 'School'}]",[],"[{'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0034380'}, {'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}, {'cui': 'C0596170', 'cui_str': 'Binge overeating'}, {'cui': 'C0684271', 'cui_str': 'Drinkings'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}]",1247.0,0.0539145,"The program showed a BD reduction at the 4-month follow-up, although it was not shown to significantly increase the HRQoL in adolescents who reduced the number of occasions of BD and had received the intervention.","[{'ForeName': 'Ana Magdalena', 'Initials': 'AM', 'LastName': 'Vargas-Martínez', 'Affiliation': 'Department of Nursing, Faculty of Nursing, Physiotherapy and Podiatry, University of Seville, Seville, Spain; Research Institute for Evaluation and Public Policies (IRAPP), Universitat Internacional de Catalunya, Barcelona, Spain. Electronic address: avargas5@us.es.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Trapero-Bertran', 'Affiliation': 'Research Institute for Evaluation and Public Policies (IRAPP), Universitat Internacional de Catalunya, Barcelona, Spain. Electronic address: mtrapero@uic.es.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Lima-Serrano', 'Affiliation': 'Department of Nursing, Faculty of Nursing, Physiotherapy and Podiatry, University of Seville, Seville, Spain. Electronic address: mlima@us.es.'}, {'ForeName': 'Nana', 'Initials': 'N', 'LastName': 'Anokye', 'Affiliation': 'Health Economics Research Group (HERG), Brunel University, Uxbridge, London, UK. Electronic address: nana.anokye@brunel.ac.uk.'}, {'ForeName': 'Subhash', 'Initials': 'S', 'LastName': 'Pokhrel', 'Affiliation': 'Health Economics Research Group (HERG), Brunel University, Uxbridge, London, UK. Electronic address: subhash.pokhrel@brunel.ac.uk.'}, {'ForeName': 'Toni', 'Initials': 'T', 'LastName': 'Mora', 'Affiliation': 'Research Institute for Evaluation and Public Policies (IRAPP), Universitat Internacional de Catalunya, Barcelona, Spain. Electronic address: tmora@uic.es.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2019.107597'] 1348,28986072,Contraception after medication abortion in the United States: results from a cluster randomized trial.,"BACKGROUND Understanding how contraceptive choices and access differ for women having medication abortions compared to aspiration procedures can help to identify priorities for improved patient-centered postabortion contraceptive care. OBJECTIVE The objective of this study was to investigate the differences in contraceptive counseling, method choices, and use between medication and aspiration abortion patients. STUDY DESIGN This subanalysis examines data from 643 abortion patients from 17 reproductive health centers in a cluster, randomized trial across the United States. We recruited participants aged 18-25 years who did not desire pregnancy and followed them for 1 year. We measured the effect of a full-staff contraceptive training and abortion type on contraceptive counseling, choice, and use with multivariable regression models, using generalized estimating equations for clustering. We used survival analysis with shared frailty to model actual intrauterine device and subdermal implant initiation over 1 year. RESULTS Overall, 26% of participants (n = 166) had a medication abortion and 74% (n = 477) had an aspiration abortion at the enrollment visit. Women obtaining medication abortions were as likely as those having aspiration abortions to receive counseling on intrauterine devices or the implant (55%) and on a short-acting hormonal method (79%). The proportions of women choosing to use these methods (29% intrauterine device or implant, 58% short-acting hormonal) were also similar by abortion type. The proportions of women who actually used short-acting hormonal methods (71% medication vs 57% aspiration) and condoms or no method (20% vs 22%) within 3 months were not significantly different by abortion type. However, intrauterine device initiation over a year was significantly lower after the medication than the aspiration abortion (11 per 100 person-years vs 20 per 100 person-years, adjusted hazard ratio, 0.50; 95% confidence interval, 0.28-0.89). Implant initiation rates were low and similar by abortion type (5 per 100 person-years vs 4 per 100 person-years, adjusted hazard ratio, 2.41; 95% confidence interval, 0.88-6.59). In contrast to women choosing short-acting methods, relatively few of those choosing a long-acting method at enrollment, 34% of medication abortion patients and 53% of aspiration abortion patients, had one placed within 3 months. Neither differences in health insurance nor pelvic examination preferences by abortion type accounted for lower intrauterine device use among medication abortion patients. CONCLUSION Despite similar contraceptive choices, fewer patients receiving medication abortion than aspiration abortion initiated intrauterine devices over 1 year of follow-up. Interventions to help patients receiving medication abortion to successfully return for intrauterine device placement are warranted. New protocols for same-day implant placement may also help patients receiving medication abortion and desiring a long-acting method to receive one.",2018,Women obtaining medication abortions were as likely as those having aspiration abortions to receive counseling on intrauterine devices or the implant (55%) and on a short-acting hormonal method (79%).,"['women having medication abortions', '643 abortion patients from 17 reproductive health centers in a cluster, randomized trial across the United States', 'participants aged 18-25 years who did not desire pregnancy and followed them for 1 year']",['full-staff contraceptive training'],"['Implant initiation rates', 'medication abortion', 'aspiration abortion', 'health insurance nor pelvic examination preferences']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0392535', 'cui_str': 'Abortion, Induced'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0242667', 'cui_str': 'Reproductive Health'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}]","[{'cui': 'C2700616', 'cui_str': 'Manpowers'}, {'cui': 'C0009871', 'cui_str': 'Contraceptives'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C2828363', 'cui_str': 'Implant'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation (observable entity)'}, {'cui': 'C0392535', 'cui_str': 'Abortion, Induced'}, {'cui': 'C0349707', 'cui_str': 'Aspiration - action (qualifier value)'}, {'cui': 'C0021682', 'cui_str': 'Health Insurance'}, {'cui': 'C0200045', 'cui_str': 'Pelvic Examination'}, {'cui': 'C0558295', 'cui_str': 'Preferences (qualifier value)'}]",643.0,0.479193,Women obtaining medication abortions were as likely as those having aspiration abortions to receive counseling on intrauterine devices or the implant (55%) and on a short-acting hormonal method (79%).,"[{'ForeName': 'Corinne H', 'Initials': 'CH', 'LastName': 'Rocca', 'Affiliation': 'Bixby Center for Global Reproductive Health, Department of Obstetrics, Gynecology, and Reproductive Sciences, School of Medicine, University of California, San Francisco, San Francisco, CA; Advancing New Standards in Reproductive Health, Bixby Center for Global Reproductive Health, Department of Obstetrics, Gynecology, and Reproductive Sciences, School of Medicine, University of California, San Francisco, Oakland, CA. Electronic address: corinne.rocca@ucsf.edu.'}, {'ForeName': 'Suzan', 'Initials': 'S', 'LastName': 'Goodman', 'Affiliation': 'Bixby Center for Global Reproductive Health, Department of Obstetrics, Gynecology, and Reproductive Sciences, School of Medicine, University of California, San Francisco, San Francisco, CA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Grossman', 'Affiliation': 'Bixby Center for Global Reproductive Health, Department of Obstetrics, Gynecology, and Reproductive Sciences, School of Medicine, University of California, San Francisco, San Francisco, CA; Advancing New Standards in Reproductive Health, Bixby Center for Global Reproductive Health, Department of Obstetrics, Gynecology, and Reproductive Sciences, School of Medicine, University of California, San Francisco, Oakland, CA.'}, {'ForeName': 'Kara', 'Initials': 'K', 'LastName': 'Cadwallader', 'Affiliation': 'Planned Parenthood of the Great Northwest and the Hawaiian Islands, Seattle, WA.'}, {'ForeName': 'Kirsten M J', 'Initials': 'KMJ', 'LastName': 'Thompson', 'Affiliation': 'Bixby Center for Global Reproductive Health, Department of Obstetrics, Gynecology, and Reproductive Sciences, School of Medicine, University of California, San Francisco, San Francisco, CA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Talmont', 'Affiliation': 'Planned Parenthood of Northern, Central, and Southern New Jersey Inc, Morristown, NJ.'}, {'ForeName': 'J Joseph', 'Initials': 'JJ', 'LastName': 'Speidel', 'Affiliation': 'Bixby Center for Global Reproductive Health, Department of Obstetrics, Gynecology, and Reproductive Sciences, School of Medicine, University of California, San Francisco, San Francisco, CA.'}, {'ForeName': 'Cynthia C', 'Initials': 'CC', 'LastName': 'Harper', 'Affiliation': 'Bixby Center for Global Reproductive Health, Department of Obstetrics, Gynecology, and Reproductive Sciences, School of Medicine, University of California, San Francisco, San Francisco, CA.'}]",American journal of obstetrics and gynecology,['10.1016/j.ajog.2017.09.020'] 1349,31569307,The Effects of Goal Framing on Energy Drink Consumption: The Moderating Role of Temporal Framing.,"BACKGROUND With the rapid expansion of the energy drink market, concerns associated with its adverse effects have been raised. This research examines how goal framing moderated by temporal framing affects attitude, subjective norm, and perceived behavioral control related to energy drink consumption. METHODS A 2 (goal framing: gain vs. loss) × 2 (temporal framing: present-oriented vs. future-oriented) randomised experiment was employed. The sample consisted of 195 college students who consume energy drinks. RESULTS Results showed that a future-oriented message was more effective than a present-oriented one when used in gain framing in increasing perceived behavioral control, as predicted. A future-oriented message was also more effective in increasing perceived negative subjective norms, but only when used in loss framing; this was the opposite of the predicted result. CONCLUSIONS The findings extend previous research on goal framing by (1) identifying an important moderator-temporal framing-in processing health promotion messages about energy drink consumption and (2) examining such moderated effects on different psychological factors. The findings of this study are expected to inform the development of more effective message strategies in health domains.",2019,"A future-oriented message was also more effective in increasing perceived negative subjective norms, but only when used in loss framing; this was the opposite of the predicted result. ",['195 college students who consume energy drinks'],[],['Energy Drink Consumption'],"[{'cui': 'C4517624', 'cui_str': '195'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C3179078', 'cui_str': 'Energy Drinks'}]",[],"[{'cui': 'C3179078', 'cui_str': 'Energy Drinks'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]",,0.0554904,"A future-oriented message was also more effective in increasing perceived negative subjective norms, but only when used in loss framing; this was the opposite of the predicted result. ","[{'ForeName': 'Jarim', 'Initials': 'J', 'LastName': 'Kim', 'Affiliation': 'Yonsei University, Seoul, Republic of Korea.'}]",Applied psychology. Health and well-being,['10.1111/aphw.12184'] 1350,32414381,Results of caring and reaching for health (CARE): a cluster-randomized controlled trial assessing a worksite wellness intervention for child care staff.,"BACKGROUND Child care workers are among the lowest paid US workers and experience a wide array of health concerns. The physical and mental demands of their job and the lack of employer-provided health-insurance increase health risks. The Caring and Reaching for Health (CARE) study evaluated a 6-month Healthy Lifestyles intervention targeting child care workers' physical activity (primary outcome), other health behaviors, and their workplace health environment. METHODS Eligible child care centers, defined as being in operation for at least 2 years and employing at least four staff, were enrolled into CARE's cluster-randomized trial. Centers and their child care staff were randomly assigned to either the Healthy Lifestyles (HL) intervention arm or the Healthy Finances (HF) attention control arm using a block randomization approach. Intervention components were delivered through in-person workshops, center-level displays, informational magazines, director coaching, electronic messaging, and an interactive website. Outcome measures were collected during center visits at baseline and immediately post-intervention by trained data collectors blinded to center arm assignment. Workers' physical activity was assessed with accelerometers, worn for 7 days. Secondary outcome measures included biometric assessments of health and fitness, web-based surveys about health behaviors, and an environmental audit of workplace supports for health. Multi-level linear mixed models assessed worker- and center-level changes in these outcomes. RESULTS Participants included 553 child care workers representing 56 centers (HL = 250 staff/28 centers, HF = 303 staff/28 centers). At 6 months, moderate-to-vigorous physical activity declined slightly in both arms (- 1.3 min/day, 95% CI: - 3.0, 0.3 in HL; - 1.9 min/day, 95% CI: - 3.3, - 0.5 in HF), but there was no significant group by time interaction. Several secondary outcomes for other health behaviors and workplace health environment showed improvements in favor of the intervention arm, yet differences did not remain statistically significant after adjustment for multiple comparisons. CONCLUSIONS While the Healthy Lifestyles intervention did not improve health behaviors or the workplace health environment, results confirmed the pressing need to focus on the health of child care workers. Future interventions should focus on prevalent health issues (e.g., weight, stress), include both high-tech and high-touch intervention strategies, and address work conditions or other social determinants of health (e.g. wages) as a means of improving the health of these essential workers. TRIAL REGISTRATION Care2BWell: Worksite Wellness for Child Care (NCT02381938).",2020,"CONCLUSIONS While the Healthy Lifestyles intervention did not improve health behaviors or the workplace health environment","['Centers and their child care staff', ""Eligible child care centers, defined as being in operation for at least 2 years and employing at least four staff, were enrolled into CARE's cluster-randomized trial"", 'child care staff', 'Participants included 553 child care workers representing 56 centers (HL\u2009=\u2009250 staff/28 centers, HF\u2009=\u2009303 staff/28 centers']","[""Healthy Lifestyles intervention targeting child care workers' physical activity (primary outcome), other health behaviors, and their workplace health environment"", 'Healthy Lifestyles (HL) intervention arm or the Healthy Finances (HF) attention control arm using a block randomization approach', 'worksite wellness intervention']","['biometric assessments of health and fitness, web-based surveys about health behaviors, and an environmental audit of workplace supports for health', ""Workers' physical activity"", 'moderate-to-vigorous physical activity', 'health behaviors']","[{'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0008067', 'cui_str': 'Puericulture'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0008070', 'cui_str': 'Child day care center'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0014003', 'cui_str': 'Employment'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C4277664', 'cui_str': 'Healthy Lifestyles'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0376243', 'cui_str': 'finances'}]","[{'cui': 'C4277664', 'cui_str': 'Healthy Lifestyles'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0008067', 'cui_str': 'Puericulture'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0376243', 'cui_str': 'finances'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0162579', 'cui_str': 'Work environment'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0450985', 'cui_str': 'Alcohol use disorders identification test'}, {'cui': 'C0162579', 'cui_str': 'Work environment'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}]",,0.0874431,"CONCLUSIONS While the Healthy Lifestyles intervention did not improve health behaviors or the workplace health environment","[{'ForeName': 'Laura A', 'Initials': 'LA', 'LastName': 'Linnan', 'Affiliation': 'Department of Health Behavior, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, CB 7440, Chapel Hill, North Carolina, 27599-7440, USA. linnan@email.unc.edu.'}, {'ForeName': 'Amber E', 'Initials': 'AE', 'LastName': 'Vaughn', 'Affiliation': 'Center for Health Promotion and Disease Prevention, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Falon T', 'Initials': 'FT', 'LastName': 'Smith', 'Affiliation': 'Center for Health Promotion and Disease Prevention, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Westgate', 'Affiliation': 'Department of Biostatistics, College of Public Heath, University of Kentucky, Lexington, Kentucky, USA.'}, {'ForeName': 'Derek', 'Initials': 'D', 'LastName': 'Hales', 'Affiliation': 'Center for Health Promotion and Disease Prevention, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Gabriela', 'Initials': 'G', 'LastName': 'Arandia', 'Affiliation': 'Department of Health Behavior, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, CB 7440, Chapel Hill, North Carolina, 27599-7440, USA.'}, {'ForeName': 'Cody', 'Initials': 'C', 'LastName': 'Neshteruk', 'Affiliation': 'Department of Nutrition, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Willis', 'Affiliation': 'Center for Health Promotion and Disease Prevention, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Dianne S', 'Initials': 'DS', 'LastName': 'Ward', 'Affiliation': 'Center for Health Promotion and Disease Prevention, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.'}]",The international journal of behavioral nutrition and physical activity,['10.1186/s12966-020-00968-x'] 1351,32415309,[Improve Hip Fracture Outcome In The Elderly Patient (iHOPE): a multicentre randomized controlled trial to test the efficacy of spinal versus general anaesthesia].,,2020,,['Elderly Patient'],['spinal versus general anaesthesia'],['Hip Fracture Outcome'],"[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0002915', 'cui_str': 'General anesthesia'}]","[{'cui': 'C0019557', 'cui_str': 'Hip fracture'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.0763614,,"[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Kowark', 'Affiliation': 'Klinik für Anästhesiologie, Universitätsklinikum RWTH Aachen, Pauwelsstr.\xa030, 52074, Aachen, Deutschland. akowark@ukaachen.de.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Der Anaesthesist,['10.1007/s00101-020-00785-8'] 1352,32419473,Lenvatinib versus sorafenib for unresectable hepatocellular carcinoma: a cost-effectiveness analysis.,"Aim: To investigate the cost-effectiveness of lenvatinib and sorafenib in the treatment of patients with nonresected hepatocellular carcinoma in China. Materials & methods: Markov model was used to simulate the direct medical cost and quality-adjusted life years (QALY) of patients with hepatocellular carcinoma. Clinical data were derived from the Phase 3 randomized clinical trial in a Chinese population. Results: Sorafenib treatment resulted in 1.794 QALYs at a cost of $43,780.73. Lenvatinib treatment resulted in 2.916 QALYs for patients weighing <60 and ≥60 kg at a cost of $57,049.43 and $75,900.36, The incremental cost-effectiveness ratio to the sorafenib treatment group was $11,825.94/QALY and $28,627.12/QALY, respectively. Conclusion: According to WHO's triple GDP per capita, the use of lenvatinib by providing drugs is a cost-effective strategy.",2020,"Lenvatinib treatment resulted in 2.916 QALYs for patients weighing <60 and ≥60 kg at a cost of $57,049.43 and $75,900.36, The incremental cost-effectiveness ratio to the sorafenib treatment group was $11,825.94/QALY and $28,627.12/QALY, respectively. ","['unresectable hepatocellular carcinoma', 'patients with nonresected hepatocellular carcinoma in China', 'patients with hepatocellular carcinoma']","['lenvatinib and sorafenib', 'Lenvatinib versus sorafenib', 'Sorafenib']","['incremental cost-effectiveness ratio', 'direct medical cost and quality-adjusted life years (QALY']","[{'cui': 'C1112459', 'cui_str': 'Liver cell carcinoma non-resectable'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2239176', 'cui_str': 'Hepatocellular carcinoma'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C2986924', 'cui_str': 'lenvatinib'}, {'cui': 'C1516119', 'cui_str': 'sorafenib'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}]",,0.0749662,"Lenvatinib treatment resulted in 2.916 QALYs for patients weighing <60 and ≥60 kg at a cost of $57,049.43 and $75,900.36, The incremental cost-effectiveness ratio to the sorafenib treatment group was $11,825.94/QALY and $28,627.12/QALY, respectively. ","[{'ForeName': 'Hongfu', 'Initials': 'H', 'LastName': 'Cai', 'Affiliation': 'Department of Pharmacy, Fujian Medical University Union Hospital, Fuzhou, Fujian Province, China.'}, {'ForeName': 'Longfeng', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Department of Medical Oncology, Fujian Provincial Cancer Hospital, Fuzhou, Fujian Province, China.'}, {'ForeName': 'Na', 'Initials': 'N', 'LastName': 'Li', 'Affiliation': 'Department of Pharmacy, Fujian Medical University Union Hospital, Fuzhou, Fujian Province, China.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Zheng', 'Affiliation': 'Department of Pharmacy, Fujian Medical University Union Hospital, Fuzhou, Fujian Province, China.'}, {'ForeName': 'Maobai', 'Initials': 'M', 'LastName': 'Liu', 'Affiliation': 'Department of Pharmacy, Fujian Medical University Union Hospital, Fuzhou, Fujian Province, China.'}]",Journal of comparative effectiveness research,['10.2217/cer-2020-0041'] 1353,31375523,Preoperative Circulating Succinate Levels as a Biomarker for Diabetes Remission After Bariatric Surgery.,"OBJECTIVE To determine the potential use of baseline circulating succinate to predict type 2 diabetes remission after bariatric surgery. RESEARCH DESIGN AND METHODS Forty-five obese patients with diabetes were randomly assigned to Roux-en-Y gastric bypass (RYGB), sleeve gastrectomy (SG), or laparoscopic greater curvature plication. Anthropometric parameters were evaluated, and a complete biochemical analysis including circulating serum succinate concentrations was performed at baseline and 1 year after surgery. The results were externally validated in a second cohort including 88 obese patients with diabetes assigned to RYGB or SG based on clinical criteria. RESULTS Succinate baseline concentrations were an independent predictor of diabetes remission after bariatric surgery. Patients achieving remission after 1 year had lower levels of baseline succinate (47.8 [37.6-64.6] µmol/L vs. 64.1 [52.5-82.9] µmol/L; P = 0.018). Moreover, succinate concentrations were significantly decreased 1 year after surgery (58.9 [46.4-82.4] µmol/L vs. 46.0 [35.8-65.3] µmol/L, P = 0.005). In multivariate analysis, the best logistic regression model showed that baseline succinate (odds ratio [OR] 11.3, P = 0.031) and the type of surgery (OR 26.4, P = 0.010) were independently associated with remission. The C-statistic for this model was 0.899 (95% CI 0.809-0.989) in the derivation cohort, which significantly improved the prediction of remission compared with current available scores, and 0.729 (95% CI 0.612-0.846) in the validation cohort. Interestingly, patients had a different response to the type of surgery according to baseline succinate, with significant differences in remission rates. CONCLUSIONS Circulating succinate is reduced after bariatric surgery. Baseline succinate levels have predictive value for diabetes remission independently of previously described presurgical factors and improve upon the current available scores to predict remission.",2019,Patients achieving remission after 1 year had lower levels of baseline succinate (47.8 [37.6-64.6] µmol/L vs. 64.1 [52.5-82.9] µmol/L; P = 0.018).,"['88 obese patients with diabetes assigned to RYGB or SG based on clinical criteria', 'Forty-five obese patients with diabetes', 'Diabetes Remission After Bariatric Surgery']","['Roux-en-Y gastric bypass (RYGB), sleeve gastrectomy (SG), or laparoscopic greater curvature plication']","['diabetes remission', 'prediction of remission', 'remission rates', 'levels of baseline succinate', 'succinate concentrations']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C1456587', 'cui_str': 'Bariatric Surgery'}]","[{'cui': 'C0585179', 'cui_str': 'Roux-en-Y Gastric Bypass'}, {'cui': 'C3160799', 'cui_str': 'Sleeve gastrectomy'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0185026', 'cui_str': 'Plication - action (qualifier value)'}]","[{'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0038617', 'cui_str': 'Succinates'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",45.0,0.129784,Patients achieving remission after 1 year had lower levels of baseline succinate (47.8 [37.6-64.6] µmol/L vs. 64.1 [52.5-82.9] µmol/L; P = 0.018).,"[{'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Ceperuelo-Mallafré', 'Affiliation': ""Institut d'Investigació Sanitària Pere Virgili, Endocrinology and Nutrition Service, Hospital Universitari de Tarragona Joan XXIII, Tarragona, Spain.""}, {'ForeName': 'Gemma', 'Initials': 'G', 'LastName': 'Llauradó', 'Affiliation': 'CIBER de Diabetes y Enfermedades Metabólicas Asociadas (CIBERDEM)-Instituto de Salud Carlos III (ISCIII), Madrid, Spain.'}, {'ForeName': 'Noelia', 'Initials': 'N', 'LastName': 'Keiran', 'Affiliation': ""Institut d'Investigació Sanitària Pere Virgili, Endocrinology and Nutrition Service, Hospital Universitari de Tarragona Joan XXIII, Tarragona, Spain.""}, {'ForeName': 'Ester', 'Initials': 'E', 'LastName': 'Benaiges', 'Affiliation': ""Institut d'Investigació Sanitària Pere Virgili, Endocrinology and Nutrition Service, Hospital Universitari de Tarragona Joan XXIII, Tarragona, Spain.""}, {'ForeName': 'Brenno', 'Initials': 'B', 'LastName': 'Astiarraga', 'Affiliation': ""Institut d'Investigació Sanitària Pere Virgili, Endocrinology and Nutrition Service, Hospital Universitari de Tarragona Joan XXIII, Tarragona, Spain.""}, {'ForeName': 'Laia', 'Initials': 'L', 'LastName': 'Martínez', 'Affiliation': ""Institut d'Investigació Sanitària Pere Virgili, Endocrinology and Nutrition Service, Hospital Universitari de Tarragona Joan XXIII, Tarragona, Spain.""}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Pellitero', 'Affiliation': 'CIBER de Diabetes y Enfermedades Metabólicas Asociadas (CIBERDEM)-Instituto de Salud Carlos III (ISCIII), Madrid, Spain.'}, {'ForeName': 'Jose Miguel', 'Initials': 'JM', 'LastName': 'González-Clemente', 'Affiliation': 'CIBER de Diabetes y Enfermedades Metabólicas Asociadas (CIBERDEM)-Instituto de Salud Carlos III (ISCIII), Madrid, Spain.'}, {'ForeName': 'Amaia', 'Initials': 'A', 'LastName': 'Rodríguez', 'Affiliation': 'Metabolic Research Laboratory, Clínica Universidad de Navarra, CIBEROBN, Instituto de Investigación Sanitaria de Navarra, Pamplona, Spain.'}, {'ForeName': 'José Manuel', 'Initials': 'JM', 'LastName': 'Fernández-Real', 'Affiliation': ""Department of Diabetes, Endocrinology and Nutrition, Institut d'Investigació Biomèdica de Girona, CIBEROBN (CB06/03/010) and ISCIII, Girona, Spain.""}, {'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Lecube', 'Affiliation': 'Endocrinology and Nutrition Department, Hospital Universitari Arnau de Vilanova, Lleida, Spain.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Megía', 'Affiliation': ""Institut d'Investigació Sanitària Pere Virgili, Endocrinology and Nutrition Service, Hospital Universitari de Tarragona Joan XXIII, Tarragona, Spain.""}, {'ForeName': 'Nuria', 'Initials': 'N', 'LastName': 'Vilarrasa', 'Affiliation': 'CIBER de Diabetes y Enfermedades Metabólicas Asociadas (CIBERDEM)-Instituto de Salud Carlos III (ISCIII), Madrid, Spain.'}, {'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Vendrell', 'Affiliation': ""Institut d'Investigació Sanitària Pere Virgili, Endocrinology and Nutrition Service, Hospital Universitari de Tarragona Joan XXIII, Tarragona, Spain sonia.fernandezveledo@gmail.com jvo@comt.es.""}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Fernández-Veledo', 'Affiliation': ""Institut d'Investigació Sanitària Pere Virgili, Endocrinology and Nutrition Service, Hospital Universitari de Tarragona Joan XXIII, Tarragona, Spain sonia.fernandezveledo@gmail.com jvo@comt.es.""}]",Diabetes care,['10.2337/dc19-0114'] 1354,31592824,Safety and Efficacy of Nanosecond Pulsed Electric Field Treatment of Sebaceous Gland Hyperplasia.,"BACKGROUND Nanosecond pulsed electric field (nsPEF) technology involves delivery of ultrashort pulses of electrical energy and is a nonthermal, drug-free technology that has demonstrated favorable effects on cellular structures of the dermis and epidermis. OBJECTIVE Determine the tolerability and effectiveness of nsPEF treatment of sebaceous gland hyperplasia (SGH). METHODS This study was a prospective, randomized, open-label, multisite, nonsignificant risk trial in which each subject served as their own control. After injection of local anesthetic, high-intensity, ultrashort pulses of electrical energy were used to treat 72 subjects resulting in a total of 222 treated lesions. Subjects returned for 3 to 4 follow-up evaluations with photographs. RESULTS At the final study visit, 99.6% of treated SGH lesions were rated clear or mostly clear and 79.3% of the subjects were satisfied or mostly satisfied with the outcome. At 60 days after nsPEF treatment, 55% of the lesions were judged to have no hyperpigmentation and 31% exhibited mild post-treatment hyperpigmentation. At the last observation for all lesions, 32% of the 222 lesions were noted as having slight volume loss. CONCLUSION Nanosecond pulsed electric field procedure is well tolerated and is very effective in the removal of SGHs. TRIAL REGISTRATION ClinicalTrials.gov NCT03612570.",2020,"At the final study visit, 99.6% of treated SGH lesions were rated clear or mostly clear and 79.3% of the subjects were satisfied or mostly satisfied with the outcome.","['Sebaceous Gland Hyperplasia', '72 subjects resulting in a total of 222 treated lesions']","['nsPEF', 'Nanosecond Pulsed Electric Field Treatment', 'local anesthetic, high-intensity, ultrashort pulses of electrical energy']","['tolerability and effectiveness', 'Safety and Efficacy']","[{'cui': 'C0406484', 'cui_str': 'Sebaceous hyperplasia (disorder)'}, {'cui': 'C0332294', 'cui_str': 'Resulting in (attribute)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}]","[{'cui': 'C0439225', 'cui_str': 'ns'}, {'cui': 'C0337037', 'cui_str': 'Electric field (physical force)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia (procedure)'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0034107', 'cui_str': 'Pulse'}, {'cui': 'C0442828', 'cui_str': 'Electrical (qualifier value)'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",72.0,0.0271499,"At the final study visit, 99.6% of treated SGH lesions were rated clear or mostly clear and 79.3% of the subjects were satisfied or mostly satisfied with the outcome.","[{'ForeName': 'Girish S', 'Initials': 'GS', 'LastName': 'Munavalli', 'Affiliation': 'Laser & Vein Specialists, Charlotte, North Carolina.'}, {'ForeName': 'Brian D', 'Initials': 'BD', 'LastName': 'Zelickson', 'Affiliation': 'Zel Skin and Laser Specialists, Minneapolis, Minnesota.'}, {'ForeName': 'Mona M', 'Initials': 'MM', 'LastName': 'Selim', 'Affiliation': 'Zel Skin and Laser Specialists, Minneapolis, Minnesota.'}, {'ForeName': 'Suzanne L', 'Initials': 'SL', 'LastName': 'Kilmer', 'Affiliation': 'Laser & Skin Surgery Center of Northern California, Sacramento, California.'}, {'ForeName': 'Thomas E', 'Initials': 'TE', 'LastName': 'Rohrer', 'Affiliation': 'Skin Care Physicians, Chestnut, Massachusetts.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Newman', 'Affiliation': 'Premier Plastic Surgery, San Mateo, California.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Jauregui', 'Affiliation': 'Pulse Biosciences, Inc., Hayward, California.'}, {'ForeName': 'William A', 'Initials': 'WA', 'LastName': 'Knape', 'Affiliation': 'Pulse Biosciences, Inc., Hayward, California.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Ebbers', 'Affiliation': 'Pulse Biosciences, Inc., Hayward, California.'}, {'ForeName': 'Darrin', 'Initials': 'D', 'LastName': 'Uecker', 'Affiliation': 'Pulse Biosciences, Inc., Hayward, California.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Nuccitelli', 'Affiliation': 'Pulse Biosciences, Inc., Hayward, California.'}]",Dermatologic surgery : official publication for American Society for Dermatologic Surgery [et al.],['10.1097/DSS.0000000000002154'] 1355,31593855,Trait anxiety and bystander motivation to defend victims of school bullying.,"INTRODUCTION School-based bullying is an omnipresent problem, but is less frequent when bystanders are inclined to defend victims. This makes it important to focus on motivation to intervene in bullying. METHODS 202 students (M age  = 16.44 years, 52% boys) from public Swedish high schools participated in a vignette experiment. Students were randomized to one of two vignettes (victim belonging to/not belonging to ingroup). Self-report measures of motivation to defend and trait anxiety were used. RESULTS Participants reported more autonomous motivation when the victim belonged to the ingroup and more extrinsic motivation when the victim did not belong to the ingroup. Trait anxiety interacted with the manipulation: bystanders high in anxiety reported low levels of autonomous motivation when the victim did not belong to the ingroup and low levels of extrinsic motivation when the victim belonged to the ingroup. CONCLUSIONS Findings suggest that anti-bullying-programs should focus on how defender motivation is influenced by the way in which victim ingroup status is perceived and address the bystander's level of anxiety as this interacts with such perceptions.",2019,"Trait anxiety interacted with the manipulation: bystanders high in anxiety reported low levels of autonomous motivation when the victim did not belong to the ingroup and low levels of extrinsic motivation when the victim belonged to the ingroup. ","['202 students (M age \u202f=\u202f16.44 years, 52% boys) from public Swedish high schools participated in a vignette experiment', 'to defend victims of school bullying']",[],"['Trait anxiety and bystander motivation', 'Trait anxiety', 'extrinsic motivation', 'autonomous motivation', 'Self-report measures of motivation to defend and trait anxiety']","[{'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0870221', 'cui_str': 'Boys'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0036375', 'cui_str': 'School'}]",[],"[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0392342', 'cui_str': 'Extrinsic motivation (finding)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}]",,0.0156401,"Trait anxiety interacted with the manipulation: bystanders high in anxiety reported low levels of autonomous motivation when the victim did not belong to the ingroup and low levels of extrinsic motivation when the victim belonged to the ingroup. ","[{'ForeName': 'Tomas', 'Initials': 'T', 'LastName': 'Jungert', 'Affiliation': 'Lund University, Box 213, SE-221 00, Lund, Sweden. Electronic address: tomas.jungert@psy.lu.se.'}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'Perrin', 'Affiliation': 'Lund University, Box 213, SE-221 00, Lund, Sweden.'}]",Journal of adolescence,['10.1016/j.adolescence.2019.10.001'] 1356,29137895,A Four-kallikrein Panel and β-Microseminoprotein in Predicting High-grade Prostate Cancer on Biopsy: An Independent Replication from the Finnish Section of the European Randomized Study of Screening for Prostate Cancer.,"BACKGROUND A panel of four kallikrein markers (total, free, and intact prostate-specific antigen [PSA] and human kallikrein-related peptidase 2 [hK2]) improves predictive accuracy for Gleason score ≥7 (high-grade) prostate cancer among men biopsied for elevated PSA. A four-kallikrein panel model was originally developed and validated by the Dutch center of the European Randomized Study of Screening for Prostate Cancer (ERSPC). The kallikrein panel is now commercially available as 4Kscore™. OBJECTIVE To assess whether these findings could be replicated among participants in the Finnish section of ERSPC (FinRSPC) and whether β-microseminoprotein (MSP), a candidate prostate cancer biomarker, adds predictive value. DESIGN, SETTING, AND PARTICIPANTS Among 4861 biopsied screening-positive participants in the first three screening rounds of FinRSPC, a case-control subset was selected that included 1632 biopsy-positive cases matched by age at biopsy to biopsy-negative controls. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS The predictive accuracy of prespecified prediction models was compared with biopsy outcomes. RESULTS AND LIMITATIONS Among men with PSA of 4.0-25ng/ml, 1111 had prostate cancer, 318 of whom had high-grade disease. Total PSA and age predicted high-grade cancer with an area under the curve of 0.648 (95% confidence interval [CI] 0.614-0.681) and the four-kallikrein panel increased discrimination to 0.746 (95% CI 0.717-0.774). Adding MSP to the four-kallikrein panel led to a significant (Wald test; p=0.015) but small increase (0.003) in discrimination. Limitations include a risk of verification bias among men with PSA of 3.0-3.99ng/ml and the absence of digital rectal examination results. CONCLUSIONS These findings provide additional evidence that kallikrein markers can be used to inform biopsy decision-making. Further studies are needed to define the role of MSP. PATIENT SUMMARY Four kallikrein markers and β-microseminoprotein in blood improve discrimination of high-grade prostate cancer at biopsy in men with elevated prostate-specific antigen.",2019,Adding MSP to the four-kallikrein panel led to a significant (Wald test; p=0.015) but small increase (0.003) in discrimination.,"['High-grade Prostate Cancer on Biopsy', 'men with PSA of 4.0-25ng/ml, 1111 had prostate cancer, 318 of whom had high-grade disease', 'Among 4861 biopsied screening-positive participants in the first three screening rounds of FinRSPC, a case-control subset was selected that included 1632 biopsy-positive cases matched by age at biopsy to biopsy-negative controls', 'participants in the Finnish section of ERSPC (FinRSPC) and whether', 'men with elevated prostate-specific antigen', 'men with PSA of 3.0-3.99ng/ml and the absence of digital rectal examination results']","['Four kallikrein markers and β-microseminoprotein', 'kallikrein Panel and β-Microseminoprotein', 'β-microseminoprotein (MSP']",['Total PSA and age predicted high-grade cancer'],"[{'cui': 'C1962917', 'cui_str': 'High grade (lymphoma)'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0201544', 'cui_str': 'Prostate specific antigen measurement (procedure)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0178415', 'cui_str': 'Raised prostate specific antigen'}, {'cui': 'C0332197', 'cui_str': 'Absent (qualifier value)'}, {'cui': 'C1384593', 'cui_str': 'Digital Rectal Examination'}, {'cui': 'C1274040', 'cui_str': 'Result'}]","[{'cui': 'C0022478', 'cui_str': 'kallidinogenase'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0201544', 'cui_str': 'Prostate specific antigen measurement (procedure)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1962917', 'cui_str': 'High grade (lymphoma)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}]",4861.0,0.0933331,Adding MSP to the four-kallikrein panel led to a significant (Wald test; p=0.015) but small increase (0.003) in discrimination.,"[{'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Assel', 'Affiliation': 'Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Liisa', 'Initials': 'L', 'LastName': 'Sjöblom', 'Affiliation': 'Prostate Cancer Research Center, Institute of Biosciences and Medical Technology, University of Tampere, Tampere, Finland; Fimlab Laboratories, Tampere University Hospital, Tampere, Finland.'}, {'ForeName': 'Teemu J', 'Initials': 'TJ', 'LastName': 'Murtola', 'Affiliation': 'Prostate Cancer Research Center, School of Health Sciences, University of Tampere, Tampere, Finland; Department of Urology, Tampere University Hospital, Tampere, Finland.'}, {'ForeName': 'Kirsi', 'Initials': 'K', 'LastName': 'Talala', 'Affiliation': 'Finnish Cancer Registry, Helsinki, Finland.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Kujala', 'Affiliation': 'Fimlab Laboratories, Tampere University Hospital, Tampere, Finland; Department of Pathology, Tampere University Hospital, Tampere, Finland.'}, {'ForeName': 'Ulf-Håkan', 'Initials': 'UH', 'LastName': 'Stenman', 'Affiliation': 'Department of Clinical Chemistry, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Kimmo', 'Initials': 'K', 'LastName': 'Taari', 'Affiliation': 'Department of Urology, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Anssi', 'Initials': 'A', 'LastName': 'Auvinen', 'Affiliation': 'Prostate Cancer Research Center, School of Health Sciences, University of Tampere, Tampere, Finland.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Vickers', 'Affiliation': 'Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Tapio', 'Initials': 'T', 'LastName': 'Visakorpi', 'Affiliation': 'Prostate Cancer Research Center, Institute of Biosciences and Medical Technology, University of Tampere, Tampere, Finland; Fimlab Laboratories, Tampere University Hospital, Tampere, Finland.'}, {'ForeName': 'Teuvo L', 'Initials': 'TL', 'LastName': 'Tammela', 'Affiliation': 'Prostate Cancer Research Center, School of Health Sciences, University of Tampere, Tampere, Finland; Department of Urology, Tampere University Hospital, Tampere, Finland.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Lilja', 'Affiliation': 'Prostate Cancer Research Center, Institute of Biosciences and Medical Technology, University of Tampere, Tampere, Finland; Departments of Laboratory Medicine, Surgery, and Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA; Nuffield Department of Surgical Sciences, University of Oxford, Oxford, UK; Department of Translational Medicine, Lund University, Malmö, Sweden. Electronic address: liljah@mskcc.org.'}]",European urology focus,['10.1016/j.euf.2017.11.002'] 1357,30659987,Nivolumab Versus Docetaxel in a Predominantly Chinese Patient Population With Previously Treated Advanced NSCLC: CheckMate 078 Randomized Phase III Clinical Trial.,"INTRODUCTION Data on immuno-oncology agents in Chinese patients are limited despite a need for new therapies. We evaluated the efficacy and safety of nivolumab in a predominantly Chinese patient population with previously treated NSCLC. METHODS CheckMate 078 was a randomized, open-label, phase III clinical trial in patients from China, Russia, and Singapore with squamous or nonsquamous NSCLC that had progressed during/after platinum-based doublet chemotherapy (ClinicalTrials.gov: NCT02613507). Patients with EGFR/ALK alterations were excluded. Patients (N = 504) were randomized 2:1 to nivolumab (3 mg/kg every 2 weeks) or docetaxel (75 mg/m 2 every 3 weeks), stratified by performance status, tumor histology, and tumor programmed death ligand 1 expression. The primary endpoint was overall survival (OS); secondary endpoints included objective response rate, progression-free survival, and safety. RESULTS OS was significantly improved with nivolumab (n = 338) versus docetaxel (n = 166); median OS (95% confidence interval): 12.0 (10.4-14.0) versus 9.6 (7.6-11.2) months, respectively; hazard ratio (97.7% confidence interval): 0.68 (0.52-0.90); p = 0.0006. Objective response rate was 17% with nivolumab versus 4% with docetaxel; median duration of response was not reached versus 5.3 months. Minimum follow-up was 8.8 months. The frequency of grade 3 or greater treatment-related adverse events was 10% with nivolumab and 48% with docetaxel. CONCLUSIONS This is the first phase III study in a predominantly Chinese population reporting results with a programmed death 1 inhibitor. In this population with previously treated advanced NSCLC, nivolumab improved OS versus docetaxel. Results were consistent with global CheckMate 017 and 057 studies.",2019,Objective response rate was 17% with nivolumab versus 4% with docetaxel; median duration of response was not reached versus 5.3 months.,"['Predominantly Chinese Patient Population With Previously Treated Advanced NSCLC', 'CheckMate 078', 'Chinese patients', 'Patients with EGFR/ALK alterations were excluded', 'Patients (N\xa0= 504', 'predominantly Chinese patient population with previously treated NSCLC.\nMETHODS\n\n\nCheckMate 078 was a randomized, open-label, phase III clinical trial in patients from China, Russia, and Singapore with squamous or nonsquamous NSCLC that had progressed during/after platinum-based doublet chemotherapy (ClinicalTrials.gov: NCT02613507']","['Nivolumab Versus Docetaxel', 'nivolumab', 'docetaxel']","['frequency of grade 3 or greater treatment-related adverse events', 'Objective response rate', 'median duration of response', 'median OS', 'overall survival (OS', 'efficacy and safety', 'objective response rate, progression-free survival, and safety']","[{'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C1292718', 'cui_str': 'Is a'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C1096780', 'cui_str': 'Clinical Trial, Phase 3'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}, {'cui': 'C0035970', 'cui_str': 'Russian Federation (Europe)'}, {'cui': 'C0037173', 'cui_str': 'Singapore'}, {'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}]","[{'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",504.0,0.221729,Objective response rate was 17% with nivolumab versus 4% with docetaxel; median duration of response was not reached versus 5.3 months.,"[{'ForeName': 'Yi-Long', 'Initials': 'YL', 'LastName': 'Wu', 'Affiliation': 'Department of Pulmonary Oncology, Guangdong Lung Cancer Institute, Guangdong General Hospital & Guangdong Academy of Medical Sciences, Guangzhou, China. Electronic address: syylwu@live.cn.'}, {'ForeName': 'Shun', 'Initials': 'S', 'LastName': 'Lu', 'Affiliation': 'Department of Oncology, Shanghai Lung Cancer Center, Shanghai Chest Hospital, Shanghai JiaoTong University, Shanghai, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Cheng', 'Affiliation': 'Department of Thoracic Oncology, Jilin Cancer Hospital, Changchun, China.'}, {'ForeName': 'Caicun', 'Initials': 'C', 'LastName': 'Zhou', 'Affiliation': 'Department of Medical Oncology, Shanghai Pulmonary Hospital, Tongji University, Shanghai, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Tony', 'Initials': 'T', 'LastName': 'Mok', 'Affiliation': 'Department of Clinical Oncology, The Chinese University of Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Department of Medical Oncology, Sun Yat-Sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Hai-Yan', 'Initials': 'HY', 'LastName': 'Tu', 'Affiliation': 'Department of Pulmonary Oncology, Guangdong Lung Cancer Institute, Guangdong General Hospital & Guangdong Academy of Medical Sciences, Guangzhou, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Wu', 'Affiliation': 'Department II of Thoracic Medicine, Hunan Cancer Hospital, Changsha, China.'}, {'ForeName': 'Jifeng', 'Initials': 'J', 'LastName': 'Feng', 'Affiliation': 'Department of Medical Oncology, Jiangsu Cancer Hospital, Jiangsu Institute of Cancer Research, Nanjing Medical University Affiliated Cancer Hospital, Nanjing, China.'}, {'ForeName': 'Yiping', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Medical Oncology, Zhejiang Cancer Hospital, Hangzhou, China.'}, {'ForeName': 'Alexander Valerievich', 'Initials': 'AV', 'LastName': 'Luft', 'Affiliation': 'Department of Oncology No 1 (Thoracic Surgery), Leningrad Regional Clinical Hospital, St. Petersburg, Russia.'}, {'ForeName': 'Jianying', 'Initials': 'J', 'LastName': 'Zhou', 'Affiliation': 'Department of Respiratory Diseases, First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, China.'}, {'ForeName': 'Zhiyong', 'Initials': 'Z', 'LastName': 'Ma', 'Affiliation': 'Department of Internal Medicine, The Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, China.'}, {'ForeName': 'You', 'Initials': 'Y', 'LastName': 'Lu', 'Affiliation': 'Department of Thoracic Oncology, West China Hospital, Chengdu, China.'}, {'ForeName': 'Chengping', 'Initials': 'C', 'LastName': 'Hu', 'Affiliation': 'Department of Respiratory Medicine, Xiangya Hospital, Central South University, Changsha, China.'}, {'ForeName': 'Yuankai', 'Initials': 'Y', 'LastName': 'Shi', 'Affiliation': 'Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Baudelet', 'Affiliation': 'Department of Statistics, Bristol-Myers Squibb, Lawrence Township, New Jersey.'}, {'ForeName': 'Junliang', 'Initials': 'J', 'LastName': 'Cai', 'Affiliation': 'Department of Immuno-oncology, Bristol-Myers Squibb, Lawrence Township, New Jersey.'}, {'ForeName': 'Jianhua', 'Initials': 'J', 'LastName': 'Chang', 'Affiliation': 'Department of Medical Oncology, Fudan University Shanghai Cancer Center, Shanghai, China.'}]",Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer,['10.1016/j.jtho.2019.01.006'] 1358,31586251,Virtual pointer for gaze guidance in laparoscopic surgery.,"BACKGROUND A challenge of laparoscopic surgery is learning how to interpret the indirect view of the operative field. Acquiring professional vision-understanding what to see and which information to attend to, is thereby an essential part of laparoscopic training and one in which trainers exert great effort to convey. We designed a virtual pointer (VP) that enables experts to point or draw free-hand sketches over an intraoperative laparoscopic video for a novice to see. This study aimed to investigate the efficacy of the virtual pointer in guiding novices' gaze patterns. METHODS We conducted a counter-balanced, within-subject trial to compare the novices' gaze behaviors in laparoscopic training with the virtual pointer compared to a standard training condition, i.e., verbal instruction with un-mediated gestures. In the study, seven trainees performed four simulated laparoscopic tasks guided by an experienced surgeon as the trainer. A Tobii Pro X3-120 eye-tracker was used to capture the trainees' eye movements. The measures include fixation rate, i.e., the frequency of trainees' fixations, saccade amplitude, and fixation concentration, i.e., the closeness of trainees' fixations. RESULTS No significant difference in fixation rate or saccade amplitude was found between the virtual pointer condition and the standard condition. In the virtual pointer condition, trainees' fixations were more concentrated (p = 0.039) and longer fixations were more clustered, compared to the Standard condition (p = 0.008). CONCLUSIONS The virtual pointer effectively improved surgical trainees' in-the-moment gaze focus during the laparoscopic training by reducing their gaze dispersion and concentrating their attention on the anatomical target. These results suggest that technologies which support gaze training should be expert-driven and intraoperative to efficiently modify novices' gaze behaviors.",2020,"In the virtual pointer condition, trainees' fixations were more concentrated (p = 0.039) and longer fixations were more clustered, compared to the Standard condition (p = 0.008). ",['laparoscopic surgery'],"['simulated laparoscopic tasks guided by an experienced surgeon as the trainer', 'laparoscopic surgery', 'laparoscopic training with the virtual pointer compared to a standard training condition, i.e., verbal instruction with un-mediated gestures']","['longer fixations', ""fixation rate, i.e., the frequency of trainees' fixations, saccade amplitude, and fixation concentration, i.e., the closeness of trainees' fixations"", 'fixation rate or saccade amplitude', 'surgical trainees']","[{'cui': 'C0751429', 'cui_str': 'Surgical Procedures, Laparoscopic'}]","[{'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0582175', 'cui_str': 'Surgeon (occupation)'}, {'cui': 'C0453962', 'cui_str': 'Trainers (physical object)'}, {'cui': 'C0751429', 'cui_str': 'Surgical Procedures, Laparoscopic'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0324413', 'cui_str': 'Pointer'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0439824', 'cui_str': 'Verbal (qualifier value)'}, {'cui': 'C0039401', 'cui_str': 'Teaching'}, {'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}, {'cui': 'C0017510', 'cui_str': 'Gestures'}]","[{'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0185023', 'cui_str': 'pexy'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0036019', 'cui_str': 'Saccadic Eye Movements'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}]",120.0,0.0317301,"In the virtual pointer condition, trainees' fixations were more concentrated (p = 0.039) and longer fixations were more clustered, compared to the Standard condition (p = 0.008). ","[{'ForeName': 'Yuanyuan', 'Initials': 'Y', 'LastName': 'Feng', 'Affiliation': 'Department of Information Systems, University of Maryland, Baltimore County, Baltimore, MD, USA. fengy1@umbc.edu.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'McGowan', 'Affiliation': 'Department of Information Systems, University of Maryland, Baltimore County, Baltimore, MD, USA.'}, {'ForeName': 'Azin', 'Initials': 'A', 'LastName': 'Semsar', 'Affiliation': 'Department of Information Systems, University of Maryland, Baltimore County, Baltimore, MD, USA.'}, {'ForeName': 'Hamid R', 'Initials': 'HR', 'LastName': 'Zahiri', 'Affiliation': 'Department of Surgery, Anna Arundel Medical Center, Annapolis, MD, USA.'}, {'ForeName': 'Ivan M', 'Initials': 'IM', 'LastName': 'George', 'Affiliation': 'Department of Surgery, Johns Hopkins Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Park', 'Affiliation': 'Department of Surgery, Anna Arundel Medical Center, Annapolis, MD, USA.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Kleinsmith', 'Affiliation': 'Department of Information Systems, University of Maryland, Baltimore County, Baltimore, MD, USA.'}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Mentis', 'Affiliation': 'Department of Information Systems, University of Maryland, Baltimore County, Baltimore, MD, USA.'}]",Surgical endoscopy,['10.1007/s00464-019-07141-x'] 1359,28332858,Modified Cognitive Behavioral Therapy for Insomnia in Depressed Adolescents: A Pilot Study.,"Objective/Background: The purpose of the study was to pilot a five-week insomnia treatment in adolescents with major depressive disorder (MDD) and insomnia. This was an open-label trial of a modified-group cognitive behavioral therapy for insomnia (CBTI). Participants: Adolescents with MDD ( n = 16; mean age = 17.3 +/- 1.7), characterized by the Children's Depression Rating Scale-Revised T-score ≥ 55 and insomnia, characterized by > 30 min to fall or return to sleep and an Insomnia Severity Index (ISI) score of ≥ 7 participated. Methods: Sleep diaries, actigraphy, weekly ISI, Quick Inventory of Depressive Symptomatology (QIDS), and Multidimensional Fatigue Inventory (MFI) were completed. Results: Paired t -tests comparing pre- and posttreatment revealed a decrease in sleep onset latency from 41 min +/- 14 min to 18 min +/- 8.9 min ( t = 5.9, p = .004). Linear mixed modeling across sessions revealed that ISI ( B = 11.0, SE = 0.94, p < .001), QIDS ( B = 11.3, SE = 0.96, p < .001), and MFI ( B = 30.0, SE = 4.4, p < .001) improved across treatment. Daily sleep diaries showed decreased wake during the night ( B = 22.8, SE = 7.19, p = .008), increased sleep time ( B = 382.4, SE = 71.89, p < .001), and increased quality of sleep ( B = 3.7, SE = 0.37, p < .001). When asked whether group members would recommend this group, 27% responded ""yes"" and 73% responded ""definitely yes."" Conclusions: Additional controlled studies utilizing sleep-focused therapy in depressed adolescents with insomnia are warranted.",2019,"Daily sleep diaries showed decreased wake during the night (B = 22.8, SE = 7.19, p = .008), increased sleep time (B = 382.4, SE = 71.89, p < .001), and increased quality of sleep (B = 3.7, SE = 0.37, p < .001).","['adolescents with major depressive disorder (MDD) and insomnia', 'Adolescents with MDD (n = 16; mean age = 17.3 ', 'insomnia (CBTI', 'depressed adolescents with insomnia', 'Depressed Adolescents']","['Modified Cognitive Behavioral Therapy', 'modified-group cognitive behavioral therapy', 'yes"" and 73% responded ""definitely yes']","['Daily sleep diaries', 'sleep onset latency', ""Children's Depression Rating Scale-Revised T-score ≥ 55 and insomnia, characterized by > 30 min to fall or return to sleep and an Insomnia Severity Index (ISI) score"", 'increased sleep time', 'QIDS', 'MFI', 'Sleep diaries, actigraphy, weekly ISI, Quick Inventory of Depressive Symptomatology (QIDS), and Multidimensional Fatigue Inventory (MFI', 'quality of sleep']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1298907', 'cui_str': 'Yes'}]","[{'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0376660', 'cui_str': 'Diary'}, {'cui': 'C4505222', 'cui_str': 'REM Sleep Latency'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0222045'}, {'cui': 'C3854607', 'cui_str': 'T score'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C3875152', 'cui_str': 'Characterizes'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0000921', 'cui_str': 'Falls'}, {'cui': 'C0332156', 'cui_str': 'Return to (contextual qualifier) (qualifier value)'}, {'cui': 'C4706228', 'cui_str': 'Insomnia Severity Index score (observable entity)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1171301', 'cui_str': 'Actigraphy'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C4720917', 'cui_str': 'Quick inventory of depressive symptomatology (assessment scale)'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep (observable entity)'}]",,0.0345799,"Daily sleep diaries showed decreased wake during the night (B = 22.8, SE = 7.19, p = .008), increased sleep time (B = 382.4, SE = 71.89, p < .001), and increased quality of sleep (B = 3.7, SE = 0.37, p < .001).","[{'ForeName': 'Deirdre A', 'Initials': 'DA', 'LastName': 'Conroy', 'Affiliation': 'Department of Psychiatry, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Alison M', 'Initials': 'AM', 'LastName': 'Czopp', 'Affiliation': 'Department of Psychiatry, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Dawn M', 'Initials': 'DM', 'LastName': 'Dore-Stites', 'Affiliation': 'Pediatric Behavioral Development, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Richard R', 'Initials': 'RR', 'LastName': 'Dopp', 'Affiliation': 'Department of Psychiatry, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Roseanne', 'Initials': 'R', 'LastName': 'Armitage', 'Affiliation': 'Department of Psychiatry, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Timothy F', 'Initials': 'TF', 'LastName': 'Hoban', 'Affiliation': 'Pediatric Sleep Medicine and Clinical Neurophysiology, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'J Todd', 'Initials': 'JT', 'LastName': 'Arnedt', 'Affiliation': 'Department of Psychiatry, University of Michigan, Ann Arbor, Michigan.'}]",Behavioral sleep medicine,['10.1080/15402002.2017.1299737'] 1360,28157776,Translating Evidence-Based Protocols Into the Home Healthcare Setting.,"Activity-limiting pain is common among older home care patients and pain management is complicated by the high prevalence of physical frailty and multimorbidity in the home care population. A comparative effectiveness study was undertaken at a large urban home care agency to examine an evidence-based pain self-management program delivered by physical therapists (PTs). This article focuses on PT training, methods implemented to reinforce content after training and to encourage uptake of the program with appropriate patients, and therapists' fidelity to the program. Seventeen physical therapy teams were included in the cluster randomized controlled trial, with 8 teams (155 PTs) assigned to a control and 9 teams (165 PTs) assigned to a treatment arm. Treatment therapists received interactive training over two sessions, with a follow-up session 6 months later. Additional support was provided via emails, e-learning materials including videos, and a therapist manual. Program fidelity was assessed by examining PT pain documentation in the agency's electronic health record. PT feedback on the program was obtained via semistructured surveys. There were no between-group differences in the number of PTs documenting program elements with the exception of instruction in the use of imagery, which was documented by a higher percentage of intervention therapists (p = 0.002). PTs felt comfortable teaching the program elements, but cited time as the biggest barrier to implementing the protocol. Possible explanations for study results suggesting limited adherence to the program protocol by intervention-group PTs include the top-down implementation strategy, competing organizational priorities, program complexity, competing patient priorities, and inadequate patient buy-in. Implications for the implementation of complex new programs in the home healthcare setting are discussed.",2017,"There were no between-group differences in the number of PTs documenting program elements with the exception of instruction in the use of imagery, which was documented by a higher percentage of intervention therapists (p = 0.002).","['older home care patients and pain management', 'Seventeen physical therapy teams']","['physical therapists (PTs', 'interactive training']","['PT feedback', 'PT pain documentation']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0204977', 'cui_str': 'Home Care'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0002766', 'cui_str': 'Pain management (procedure)'}, {'cui': 'C0450331', 'cui_str': '17 (qualifier value)'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}]","[{'cui': 'C2362565', 'cui_str': 'Physiotherapists'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0920316', 'cui_str': 'Documentation'}]",,0.0200207,"There were no between-group differences in the number of PTs documenting program elements with the exception of instruction in the use of imagery, which was documented by a higher percentage of intervention therapists (p = 0.002).","[{'ForeName': 'Katherine L', 'Initials': 'KL', 'LastName': 'Beissner', 'Affiliation': 'Katherine L. Beissner, PT, PhD, is a Professor at Department of Physical Therapy Education, SUNY Upstate Medical University, Syracuse, New York. Eileen Bach, DPT, MEd, COS-C, CHC, is a Provider and Corporate Compliance Specialist at Compliance and Regulatory Affairs, Visiting Nurse Service of NY, New York, New York. Christopher M. Murtaugh, PhD, is an Associate Director at Center for Home Care Policy & Research, Visiting Nurse Service of NY, New York, New York. MaryGrace Trifilio, BA, is a Research Analyst I at Center for Home Care Policy & Research, Visiting Nurse Service of NY, New York, New York. Charles R. Henderson, Jr., PhD, is a Senior Research Associate at Department of Human Development, Cornell University, Ithaca, New York. Yolanda Barrón, MS, is a Senior Statistical Analyst at Center for Home Care Policy & Research, Visiting Nurse Service of NY, New York, New York. Melissa A. Trachtenberg, BA, is a Research Project Manager at Center for Home Care Policy & Research, Visiting Nurse Service of NY, New York, New York. M. Carrington Reid, MD, is an Associate Professor at Department of Medicine, Weill Cornell Medical Center, New York, New York.'}, {'ForeName': 'Eileen', 'Initials': 'E', 'LastName': 'Bach', 'Affiliation': ''}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': 'Murtaugh', 'Affiliation': ''}, {'ForeName': 'MaryGrace', 'Initials': 'M', 'LastName': 'Trifilio', 'Affiliation': ''}, {'ForeName': 'Charles R', 'Initials': 'CR', 'LastName': 'Henderson', 'Affiliation': ''}, {'ForeName': 'Yolanda', 'Initials': 'Y', 'LastName': 'Barrón', 'Affiliation': ''}, {'ForeName': 'Melissa A', 'Initials': 'MA', 'LastName': 'Trachtenberg', 'Affiliation': ''}, {'ForeName': 'M Carrington', 'Initials': 'MC', 'LastName': 'Reid', 'Affiliation': ''}]",Home healthcare now,['10.1097/NHH.0000000000000486'] 1361,31564620,The Effıcacy of External Cooling and Vibration on Decreasing the Pain of Local Anesthesia Injections During Dental Treatment in Children: A Randomized Controlled Study.,"PURPOSE This study was performed to assess the efficacy of external cooling and vibration devices on the pain of injections applied to the site of local anesthesia in children during dental treatment. DESIGN This study is a randomized controlled trial. METHODS This study was conducted with 60 children requiring mandibular baby teeth extraction. The children in the experimental group were anesthetized after cold application, and a vibration device was administered on the application site 2 minutes before and during the anesthesia process, whereas those in the control group were only given local mandibular anesthesia without any other procedure. FINDINGS It was found that the mean pain score was lower in the experimental group with a significant difference between the groups (P < .05). CONCLUSIONS This study found that the application of external cooling and vibration on the site of local anesthesia had a significant effect on the injection pain experienced by children during dental treatment.",2020,"It was found that the mean pain score was lower in the experimental group with a significant difference between the groups (P < .05). ","['60 children requiring mandibular baby teeth extraction', 'children during dental treatment', 'Children']","['external cooling and vibration devices', 'external cooling and vibration', 'External Cooling and Vibration', 'local mandibular anesthesia without any other procedure']","['Pain of Local Anesthesia Injections', 'mean pain score', 'injection pain']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C3266841', 'cui_str': 'Baby Teeth'}, {'cui': 'C0185115', 'cui_str': 'Extraction - action (qualifier value)'}, {'cui': 'C0011331', 'cui_str': 'Dental Care'}]","[{'cui': 'C0205101', 'cui_str': 'External (qualifier value)'}, {'cui': 'C0459800', 'cui_str': 'Vibration'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia (procedure)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}]",,0.0371066,"It was found that the mean pain score was lower in the experimental group with a significant difference between the groups (P < .05). ","[{'ForeName': 'Elif', 'Initials': 'E', 'LastName': 'Bilsin', 'Affiliation': 'Gaziantep University, Health Science Faculty, Şehitkamil, Gaziantep, Turkey. Electronic address: elifbilsin-86@hotmail.com.'}, {'ForeName': 'Zeynep', 'Initials': 'Z', 'LastName': 'Güngörmüş', 'Affiliation': 'Gaziantep University, Health Science Faculty, Şehitkamil, Gaziantep, Turkey.'}, {'ForeName': 'Metin', 'Initials': 'M', 'LastName': 'Güngörmüş', 'Affiliation': 'Gaziantep University, Faculty of Dentistry, Şehitkamil, Gaziantep, Turkey.'}]",Journal of perianesthesia nursing : official journal of the American Society of PeriAnesthesia Nurses,['10.1016/j.jopan.2019.06.007'] 1362,32419645,Coldzyme® Mouth Spray reduces duration of upper respiratory tract infection symptoms in endurance athletes under free living conditions.,"Upper respiratory tract infection (URTI) can compromise athlete preparation and performance, so countermeasures are desirable. The aim of this study was to assess the effects of ColdZyme® Mouth Spray (ColdZyme) on self-reported upper respiratory tract infection in competitive endurance athletes under free-living conditions. One hundred and twenty-three endurance-trained, competitive athletes (recruited across 4 sites in England, UK) were randomised to control (no treatment, n  = 61) or ColdZyme ( n  = 62) for a 3-month study period (between December 2017 and March 2018; or December 2018 and April 2019). They recorded daily training and illness symptoms (Jackson common cold questionnaire) during the study period. A total of 130 illness episodes were reported during the study with no difference in incidence between groups (episodes per person: 1.1 ± 0.9 Control, 1.0 ± 0.8 ColdZyme, P  = 0.290). Episode duration was significantly shorter in ColdZyme compared to Control: Control 10.4 ± 8.5 days vs. ColdZyme 7.7 ± 4.0 days, P  = 0.016). Further analysis to compare episodes with poor vs. good compliance with ColdZyme instructions for use (IFU) within the ColdZyme group showed a greater reduction in duration of URTI when compliance was good (9.3 ± 4.5 days in ColdZyme poor IFU compliance vs. 6.9 ± 3.5 days in ColdZyme good IFU compliance, P  = 0.040). ColdZyme may be an effective countermeasure to reduce URTI duration, which was significantly lower (by 26-34%) in the ColdZyme treatment group (with no influence on incidence). This may have implications for athlete performance.",2020,"Episode duration was significantly shorter in ColdZyme compared to Control: Control 10.4 ± 8.5 days vs ColdZyme 7.7 ± 4.0 days, P = 0.016).","['endurance athletes under free living conditions', 'One hundred and twenty-three endurance-trained, competitive athletes (recruited across 4 sites in England, UK', 'competitive endurance athletes under free-living conditions']","['ColdZyme® Mouth Spray (ColdZyme', 'control (no treatment, n\u2009=\u200961) or ColdZyme', 'ColdZyme® Mouth Spray']","['daily training and illness symptoms (Jackson common cold questionnaire', 'duration of URTI', 'Episode duration', 'URTI duration']","[{'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0425273', 'cui_str': 'Competitive athlete'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0014282', 'cui_str': 'England'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C1154182', 'cui_str': 'Spray dose form'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0009443', 'cui_str': 'Common cold'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0041912', 'cui_str': 'Upper respiratory infection'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}]",,0.025327,"Episode duration was significantly shorter in ColdZyme compared to Control: Control 10.4 ± 8.5 days vs ColdZyme 7.7 ± 4.0 days, P = 0.016).","[{'ForeName': 'Glen', 'Initials': 'G', 'LastName': 'Davison', 'Affiliation': 'Endurance Research Group, School of Sport & Exercise Sciences, University of Kent, Canterbury, UK.'}, {'ForeName': 'Eleanor', 'Initials': 'E', 'LastName': 'Perkins', 'Affiliation': 'Endurance Research Group, School of Sport & Exercise Sciences, University of Kent, Canterbury, UK.'}, {'ForeName': 'Arwel W', 'Initials': 'AW', 'LastName': 'Jones', 'Affiliation': 'Lincoln Institute for Health, University of Lincoln, Lincoln, UK.'}, {'ForeName': 'Gabriella M', 'Initials': 'GM', 'LastName': 'Swart', 'Affiliation': 'Endurance Research Group, School of Sport & Exercise Sciences, University of Kent, Canterbury, UK.'}, {'ForeName': 'Alex R', 'Initials': 'AR', 'LastName': 'Jenkins', 'Affiliation': 'Lincoln Institute for Health, University of Lincoln, Lincoln, UK.'}, {'ForeName': 'Hayley', 'Initials': 'H', 'LastName': 'Robinson', 'Affiliation': 'Lincoln Institute for Health, University of Lincoln, Lincoln, UK.'}, {'ForeName': 'Kimberly', 'Initials': 'K', 'LastName': 'Dargan', 'Affiliation': 'Endurance Research Group, School of Sport & Exercise Sciences, University of Kent, Canterbury, UK.'}]",European journal of sport science,['10.1080/17461391.2020.1771429'] 1363,31553463,Assessment of Laparoscopic Distal Gastrectomy After Neoadjuvant Chemotherapy for Locally Advanced Gastric Cancer: A Randomized Clinical Trial.,"Importance Laparoscopic distal gastrectomy and neoadjuvant chemotherapy are increasingly used to treat locally advanced gastric cancer. However, the safety and efficacy of the laparoscopic procedure after neoadjuvant chemotherapy remain unclear. Objective To evaluate the short-term outcomes of patients with locally advanced gastric cancer who received either laparoscopic distal gastrectomy or open distal gastrectomy. Design, Setting, and Participants Between April 23, 2015, and November 16, 2017, a phase 2, open-label, noninferiority randomized clinical trial was conducted at the Gastrointestinal Cancer Center of Peking University Cancer Hospital and Institute in Beijing, China. Patients (n = 96) between 18 and 80 years of age with locally advanced gastric cancer (cT2-4aN+M0) who were receiving neoadjuvant chemotherapy were enrolled and randomized. An as-treated population and a modified intention-to-treat (mITT) population were defined for the data analysis. Interventions Patients were randomized to undergo either laparoscopy-assisted distal gastrectomy (LADG) with D2 lymphadenectomy or open distal gastrectomy (ODG) with D2 lymphadenectomy. Main Outcomes and Measures The primary end point was 3-year recurrence-free survival rate. Secondary end points were surgical radicality, 30-day postoperative morbidity and mortality, 2-week postoperative recovery indexes, and adjuvant chemotherapy completion status. Results In total, 95 patients were eligible for as-treated analyses (LADG: 45, of whom 13 were female [29%], with a median [interquartile range (IQR)] age of 59 [52-65] years; ODG: 50, of whom 16 were female [32%], with a median [IQR] age of 61 [55-64] years) and mITT analyses (LADG: 47, of whom 14 were female [30%], with a median [IQR] age of 59 [52-65] years; ODG: 48, of whom 15 were female [31%], with a median [IQR] age of 61 [55-64] years). In the as-treated analyses, the LADG group had a significantly lower postoperative complication rate than the ODG group (20% vs 46%; P = .007). The postoperative visual analog scale score for pain was 1.2 units lower on postoperative day 2 only in the LADG group (95% CI, -2.1 to -0.3; P = .008). Patients in the LADG group had better adjuvant chemotherapy completion (adjusted odds ratio, 4.39; 95% CI, 1.63-11.80; P = .003) and were less likely to terminate adjuvant chemotherapy because of adverse effects (10 [22%] vs 21 [42%]; P = .04). The mITT analyses showed similar results to as-treated analyses. Conclusions and Relevance This trial found that LADG appears to offer the benefits of better postoperative safety and adjuvant chemotherapy tolerance compared with ODG for patients with locally advanced gastric cancer who received neoadjuvant chemotherapy. Trial Registration ClinicalTrials.gov identifier: NCT02404753.",2019,"Patients in the LADG group had better adjuvant chemotherapy completion (adjusted odds ratio, 4.39; 95% CI, 1.63-11.80; P = .003) and were less likely to terminate adjuvant chemotherapy because of adverse effects (10 [22%] vs 21 [42%];","['patients with locally advanced gastric cancer who received either', 'age of 59 [52-65] years; ODG: 50, of whom 16 were female [32%], with a median [IQR] age of 61 [55-64] years) and mITT analyses', '47, of whom 14 were female [30%], with a median [IQR] age of 59 [52-65] years; ODG: 48, of whom 15 were female [31%], with a median [IQR] age of 61 [55-64] years', 'Participants\n\n\nBetween April 23, 2015, and November 16, 2017, a phase 2, open-label, noninferiority randomized clinical trial was conducted at the Gastrointestinal Cancer Center of Peking University Cancer Hospital and Institute in Beijing, China', 'locally advanced gastric cancer', 'Patients (n\u2009=\u200996) between 18 and 80 years of age with locally advanced gastric cancer (cT2-4aN+M0) who were receiving', '95 patients were eligible for as-treated analyses (LADG: 45, of whom 13 were female [29%], with a median [interquartile range (IQR', 'Locally Advanced Gastric Cancer', 'patients with locally advanced gastric cancer who received neoadjuvant chemotherapy']","['ODG', 'laparoscopy-assisted distal gastrectomy (LADG) with D2 lymphadenectomy or open distal gastrectomy (ODG) with D2 lymphadenectomy', 'LADG', 'Laparoscopic Distal Gastrectomy', 'neoadjuvant chemotherapy', 'laparoscopic distal gastrectomy or open distal gastrectomy', 'Laparoscopic distal gastrectomy and neoadjuvant chemotherapy', 'Neoadjuvant Chemotherapy']","['adverse effects', 'postoperative complication rate', 'adjuvant chemotherapy completion', '3-year recurrence-free survival rate', 'surgical radicality, 30-day postoperative morbidity and mortality, 2-week postoperative recovery indexes, and adjuvant chemotherapy completion status', 'postoperative visual analog scale score for pain', 'safety and efficacy']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0024623', 'cui_str': 'Cancer of Stomach'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0439560', 'cui_str': 'Phase 2 (qualifier value)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0206034', 'cui_str': 'Clinical Trials, Randomized'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0685938', 'cui_str': 'Gastrointestinal Cancer'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0019999', 'cui_str': 'Hospitals, Cancer'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C4042832', 'cui_str': 'Peking'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C0031150', 'cui_str': 'Celioscopy'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0205108', 'cui_str': 'Distal (qualifier value)'}, {'cui': 'C0017118', 'cui_str': 'Gastrectomy'}, {'cui': 'C0024203', 'cui_str': 'Lymphadenectomy'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C2919733', 'cui_str': 'Surviving free of recurrence of neoplastic disease (finding)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",95.0,0.25282,"Patients in the LADG group had better adjuvant chemotherapy completion (adjusted odds ratio, 4.39; 95% CI, 1.63-11.80; P = .003) and were less likely to terminate adjuvant chemotherapy because of adverse effects (10 [22%] vs 21 [42%];","[{'ForeName': 'Ziyu', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Gastrointestinal Cancer Center, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital and Institute, Hai-Dian District, Beijing, China.'}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Shan', 'Affiliation': 'Gastrointestinal Cancer Center, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital and Institute, Hai-Dian District, Beijing, China.'}, {'ForeName': 'Xiangji', 'Initials': 'X', 'LastName': 'Ying', 'Affiliation': 'Gastrointestinal Cancer Center, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital and Institute, Hai-Dian District, Beijing, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Gastrointestinal Cancer Center, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital and Institute, Hai-Dian District, Beijing, China.'}, {'ForeName': 'Jian-Yu', 'Initials': 'JY', 'LastName': 'E', 'Affiliation': 'Department of Epidemiology, Johns Hopkins University Bloomberg School of Public Health, Baltimore, Maryland.'}, {'ForeName': 'Yinkui', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Gastrointestinal Cancer Center, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital and Institute, Hai-Dian District, Beijing, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Ren', 'Affiliation': 'Gastrointestinal Cancer Center, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital and Institute, Hai-Dian District, Beijing, China.'}, {'ForeName': 'Xiangqian', 'Initials': 'X', 'LastName': 'Su', 'Affiliation': 'Gastrointestinal Cancer Center, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital and Institute, Hai-Dian District, Beijing, China.'}, {'ForeName': 'Jiafu', 'Initials': 'J', 'LastName': 'Ji', 'Affiliation': 'Gastrointestinal Cancer Center, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital and Institute, Hai-Dian District, Beijing, China.'}]",JAMA surgery,['10.1001/jamasurg.2019.3473'] 1364,31551606,"Monitoring of fibrinolytic system activity with plasminogen, D-dimers and FDP in primary total knee arthroplasty (TKA) after topical, intravenous or combined administration of tranexamic acid.","AIM We assessed various ways of tranexamic acid (TXA) administration on the fibrinolytic system. Blood loss, transfusions, drainage and haematoma were secondary outcomes. METHODS In this prospective study, we examined 100 patients undergoing primary total knee arthroplasty (TKA) between June and November 2018. Patients were randomly assigned to 4 groups according to the following TXA regimens: 1) loading dose 15 mg TXA/kg single intravenous administration applied at initiation of anesthesia (IV1); 2) loading dose 15 mg TXA/kg + additional dose 15 mg TXA/kg 6 h after the first application of TXA (IV2); 3) IV1 regime in combination with a local wash of 2 g of TXA in 50 mL of saline (COMB); 4) topical administration of 2 g of TXA in 50 mL of saline (TOP). RESULTS Systemic fibrinolysis interference was insignificant in all of the regimens; we did not detect significant differences between IV1, IV2 and COMB in the monitored parameters within the elapsed time after the TKA; IV regimes had the lowest total drainage blood loss; the lowest blood loss was associated with the IV1 and IV2 regimens (IV1, IV2 < COMB < TOP); the lowest incidence of haematomas was in patients treated with TXA topically (i.e., in COMB + TOP). CONCLUSION The largest antifibrinolytic effect was associated with intravenous administration of TXA. In terms of blood loss, intravenously administered TXA can interfere with the processes associated with the formation of the fibrin plug more efficiently than the simple washing of wound surfaces with TXA.",2020,"RESULTS Systemic fibrinolysis interference was insignificant in all of the regimens; we did not detect significant differences between IV1, IV2 and COMB in the monitored parameters within the elapsed time after the TKA; IV regimes had the lowest total drainage blood loss; the lowest blood loss was associated with the IV1 and IV2 regimens (IV1, IV2 < COMB < TOP); the lowest incidence of haematomas was in patients treated with TXA topically (i.e., in COMB + TOP). ","['100 patients undergoing primary total knee arthroplasty (TKA) between June and November 2018', 'primary total knee arthroplasty (TKA']","['tranexamic acid', 'plasminogen, D-dimers and FDP', 'loading dose 15 mg TXA/kg single intravenous administration applied at initiation of anesthesia (IV1); 2) loading dose 15 mg TXA/kg + additional dose 15 mg TXA/kg 6 h after the first application of TXA (IV2); 3) IV1 regime in combination with a local wash of 2 g of TXA in 50 mL of saline (COMB); 4) topical administration of 2 g of TXA in 50 mL of saline (TOP', 'tranexamic acid (TXA', 'TXA']","['lowest total drainage blood loss; the lowest blood loss', 'Systemic fibrinolysis interference', 'Blood loss, transfusions, drainage and haematoma', 'IV1, IV2 and COMB']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}]","[{'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C0032140', 'cui_str': 'Profibrinolysin'}, {'cui': 'C0060323', 'cui_str': 'D-dimer fragments'}, {'cui': 'C0294942', 'cui_str': '(18F)FDP'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0013125'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation (observable entity)'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C3714444', 'cui_str': 'Loading dose'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C1547959', 'cui_str': 'Wash - dosing instruction imperative'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0001566', 'cui_str': 'Drug Administration, Topical'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0013103', 'cui_str': 'Drainage'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C1305868', 'cui_str': 'Fibrinolysis'}, {'cui': 'C0199960', 'cui_str': 'Transfusion - action (qualifier value)'}, {'cui': 'C0018944', 'cui_str': 'Hematoma'}, {'cui': 'C3854046', 'cui_str': 'Comb'}]",100.0,0.0623355,"RESULTS Systemic fibrinolysis interference was insignificant in all of the regimens; we did not detect significant differences between IV1, IV2 and COMB in the monitored parameters within the elapsed time after the TKA; IV regimes had the lowest total drainage blood loss; the lowest blood loss was associated with the IV1 and IV2 regimens (IV1, IV2 < COMB < TOP); the lowest incidence of haematomas was in patients treated with TXA topically (i.e., in COMB + TOP). ","[{'ForeName': 'Jiri', 'Initials': 'J', 'LastName': 'Lostak', 'Affiliation': 'Department of Orthopaedics, University Hospital Olomouc and Faculty of Medicine and Dentistry, Palacky University Olomouc, Czech Republic.'}, {'ForeName': 'Jiri', 'Initials': 'J', 'LastName': 'Gallo', 'Affiliation': 'Department of Orthopaedics, University Hospital Olomouc and Faculty of Medicine and Dentistry, Palacky University Olomouc, Czech Republic.'}, {'ForeName': 'Ludek', 'Initials': 'L', 'LastName': 'Slavik', 'Affiliation': 'Department of Haemato-Oncology, University Hospital Olomouc and Faculty of Medicine and Dentistry, Palacky University Olomouc, Czech Republic.'}, {'ForeName': 'Jana', 'Initials': 'J', 'LastName': 'Zapletalova', 'Affiliation': 'Department of Medical Biophysics, Faculty of Medicine and Dentistry, Palacky University Olomouc, Czech Republic.'}, {'ForeName': 'Lubos', 'Initials': 'L', 'LastName': 'Balaz', 'Affiliation': 'Department of Orthopaedics, University Hospital Olomouc and Faculty of Medicine and Dentistry, Palacky University Olomouc, Czech Republic.'}]","Biomedical papers of the Medical Faculty of the University Palacky, Olomouc, Czechoslovakia",['10.5507/bp.2019.034'] 1365,31553204,Magnesium-Based Resorbable Scaffold Versus Permanent Metallic Sirolimus-Eluting Stent in Patients With ST-Segment Elevation Myocardial Infarction: The MAGSTEMI Randomized Clinical Trial.,"BACKGROUND The use of poly- l -lactide acid-based bioresorbable scaffolds is limited in daily clinical practice because of safety concerns and lack of physiological benefit. Magnesium-based bioresorbable scaffold (MgBRS) presents a short resorption period (<1 year) and have the potential of being thromboresistant and exhibiting early restoration of vasomotor function. To date, however, no randomized clinical trial has investigated the performance of MgBRS. Therefore, this study aimed to compare the in-stent/scaffold vasomotion between MgBRS and permanent metallic sirolimus-eluting stent (SES) at 12-month follow-up in ST-segment-elevation myocardial infarction patients. METHODS This investigator-driven, multicenter, randomized, single-blind, controlled trial randomized ST-segment-elevation myocardial infarction patients 1:1 to SES or MgBRS at 11 academic centers. The primary end point was the rate of increase (≥3%) after nitroglycerin in mean lumen diameter of the in-stent/scaffold segment at 12 months with superiority of MgBRS over SES in the as-treated population. The main secondary end points included angiographic parameters of restenosis, device-oriented composite end point, their individual components, and device thrombosis rate. Besides, endothelial-dependent vasomotor response to acetylcholine (ie, endothelial function) was also assessed in a subgroup of patients (n=69). RESULTS Between June 2017 and June 2018, 150 ST-segment-elevation myocardial infarction patients were randomized (MgBRS, n=74; SES, n=76). At 1 year, the primary end point was significantly higher in the MgBRS arm (56.5% versus 33.8%; P =0.010). Conversely, late lumen loss was significantly lower in the SES group (in-segment: 0.39±0.49mm versus 0.02±0.27mm, P <0.001; in-device: 0.61±0.55mm versus 0.06±0.21mm; P <0.001). The device-oriented composite end point was higher in the MgBRS arm driven by an increase in ischemia-driven target lesion revascularization rate (12[16.2%] versus 4[5.2%], P =0.030). Definite thrombosis rate was similar between groups (1[1.4%] in the MgBRS arm versus 2[2.6%] in the SES group; P =1.0). Endothelial function assessment at device segment evidenced a more pronounced vasoconstrictive response to maximal dose of acetylcholine in the MgBRS arm (-8.3±3.5% versus -2.4±1.3% in the SES group, P =0.003). CONCLUSIONS When compared to SES, MgBRS demonstrated a higher capacity of vasomotor response to pharmacological agents (either endothelium-independent or endothelium-dependent) at 1 year. However, MgBRS was associated with a lower angiographic efficacy, a higher rate of target lesion revascularization, without thrombotic safety concerns. CLINICAL TRIAL REGISTRATION URL: https://www.clinicaltrials.gov. Unique identifier: NCT03234348.",2019,"Endothelial function assessment at device segment evidenced a more pronounced vasoconstrictive response to maximal dose of acetylcholine in the MgBRS arm (-8.3±3.5% vs. -2.4±1.3% in the SES group, p=0.003). ","['at 11 academic centers', 'ST-segment elevation myocardial infarction (STEMI) patients', 'Patients with ST-Segment Elevation Myocardial Infarction', 'Results: Between June 2017 and June 2018, 150 STEMI patients were randomized (MgBRS, n=74; SES, n=76']","['MgBRS and permanent metallic sirolimus-eluting stent (SES', 'nitroglycerin', 'Magnesium-based bioresorbable scaffold (MgBRS', 'acetylcholine', 'Magnesium-Based Resorbable Scaffold versus Permanent Metallic Sirolimus-Eluting Stent', 'SES or MgBRS', 'poly-L lactide acid-based bioresorbable scaffolds', 'SES']","['vasomotor response', 'ischemia-driven target lesion revascularization rate', 'rate of increase', 'Endothelial function assessment', 'vasoconstrictive response', 'late lumen loss', 'angiographic efficacy', 'angiographic parameters of restenosis, the device-oriented composite endpoint, their individual components, and device thrombosis rate', 'Definite thrombosis rate']","[{'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C1536220', 'cui_str': 'ST Elevated Myocardial Infarction'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}]","[{'cui': 'C0205355', 'cui_str': 'Permanent (qualifier value)'}, {'cui': 'C0072980', 'cui_str': 'Sirolimus'}, {'cui': 'C0038257', 'cui_str': 'Stents'}, {'cui': 'C0017887', 'cui_str': 'glyceryl trinitrate'}, {'cui': 'C3540792', 'cui_str': 'Magnesium supplements, alimentary tract and metabolism'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0337143', 'cui_str': 'Scaffold, device (physical object)'}, {'cui': 'C0001041', 'cui_str': 'Acetylcholine'}, {'cui': 'C0615693', 'cui_str': 'poly(lactide), (L)-isomer'}, {'cui': 'C0001128', 'cui_str': 'Acids'}]","[{'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C0004379', 'cui_str': 'Drivings, Automobile'}, {'cui': 'C0014742', 'cui_str': 'Erythema Multiforme'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0333186', 'cui_str': 'Restenosis'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0040053', 'cui_str': 'Thrombosis'}, {'cui': 'C0439544', 'cui_str': 'Definite (qualifier value)'}]",150.0,0.177933,"Endothelial function assessment at device segment evidenced a more pronounced vasoconstrictive response to maximal dose of acetylcholine in the MgBRS arm (-8.3±3.5% vs. -2.4±1.3% in the SES group, p=0.003). ","[{'ForeName': 'Manel', 'Initials': 'M', 'LastName': 'Sabaté', 'Affiliation': ""Interventional Cardiology Department, Cardiovascular Institute, Hospital Clínic, Institut d'Investigacions Biomèdiques August Pi I Sunyer (IDIBAPS), Barcelona, Spain (M.S., S.B.).""}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Alfonso', 'Affiliation': 'Hospital Universitario de La Princesa, Madrid, Spain (F.A., J.C.).'}, {'ForeName': 'Angel', 'Initials': 'A', 'LastName': 'Cequier', 'Affiliation': 'Hospital Universitario de Bellvitge, IDIBELL, Barcelona, Spain (A.C., J.A.G.H.).'}, {'ForeName': 'Sebastián', 'Initials': 'S', 'LastName': 'Romaní', 'Affiliation': 'Hospital San Pedro de Alcántara, Cáceres, Spain (S.R.).'}, {'ForeName': 'Pascual', 'Initials': 'P', 'LastName': 'Bordes', 'Affiliation': 'Hospital General de Alicante, Alicante, Spain (P.B.).'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Serra', 'Affiliation': 'Hospital de la Santa Creu i Sant Pau, Barcelona, Spain (A.S.).'}, {'ForeName': 'Andrés', 'Initials': 'A', 'LastName': 'Iñiguez', 'Affiliation': 'Hospital Alvaro Cunqueiro, Vigo, Spain (A.I.).'}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Salinas', 'Affiliation': 'Hospital Clínico San Carlos, Madrid, Spain (P.S.).'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'García Del Blanco', 'Affiliation': ""Hospital Vall d'Hebrón, Barcelona, Spain (B.G.D.B.).""}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Goicolea', 'Affiliation': 'Hospital Puerta de Hierro-Majadahonda, Madrid, Spain (J.G.).'}, {'ForeName': 'Rosana', 'Initials': 'R', 'LastName': 'Hernández-Antolín', 'Affiliation': 'Hospital Ramón y Cajal, Madrid, Spain (R.H.A.).'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Cuesta', 'Affiliation': 'Hospital Universitario de La Princesa, Madrid, Spain (F.A., J.C.).'}, {'ForeName': 'Joan Antoni', 'Initials': 'JA', 'LastName': 'Gómez-Hospital', 'Affiliation': 'Hospital Universitario de Bellvitge, IDIBELL, Barcelona, Spain (A.C., J.A.G.H.).'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Ortega-Paz', 'Affiliation': 'Barcicore, Cardiac Imaging Corelab, Barcelona, Spain (L.O.P., J.G.L.).'}, {'ForeName': 'Josep', 'Initials': 'J', 'LastName': 'Gomez-Lara', 'Affiliation': 'Barcicore, Cardiac Imaging Corelab, Barcelona, Spain (L.O.P., J.G.L.).'}, {'ForeName': 'Salvatore', 'Initials': 'S', 'LastName': 'Brugaletta', 'Affiliation': ""Interventional Cardiology Department, Cardiovascular Institute, Hospital Clínic, Institut d'Investigacions Biomèdiques August Pi I Sunyer (IDIBAPS), Barcelona, Spain (M.S., S.B.).""}]",Circulation,['10.1161/CIRCULATIONAHA.119.043467'] 1366,32416690,Combined Analysis of Clinical Data on HGF Gene Therapy to Treat Critical Limb Ischemia in Japan.,"OBJECTIVE The objective of this combined analysis of data from clinical trials in Japan, using naked plasmid DNA encoding hepatocyte growth factor (HGF), was to document the safety and efficacy of intramuscular HGF gene therapy in patients with critical limb ischemia (CLI). METHODS HGF gene transfer was performed in 22 patients with CLI in a single-center open trial at Osaka University; 39 patients in a randomized, placebo-controlled, multi-center phase III trial, 10 patients with Buerger's disease in a multi-center open trial; and 6 patients with CLI in a multi-center open trial using 2 or 3 intramuscular injections of naked HGF plasmid at 2 or 4 mg. Resting pain on a visual analogue scale (VAS) and wound healing as primary endpoints were evaluated at 12 weeks after the initial injection. Serious adverse events caused by gene transfer were detected in 7 out of 77 patients (9.09%). Only one patient experienced peripheral edema (1.30%), in contrast to those who had undergone treatment with VEGF. At 12 weeks after gene transfer, combined evaluation of VAS and ischemic ulcer size demonstrated a significant improvement in HGF gene therapy group as compared to the placebo group (P=0.020). RESULTS The long-term analysis revealed a sustained decrease in the size of ischemic ulcer in HGF gene therapy group. In addition, VAS score over 50 mm at baseline (total 27 patients) demonstrated a tendency (P=0.059), but not significant enough, to improve VAS score in HGF gene therapy as compared to the placebo group. CONCLUSION The findings indicated that intramuscular injection of naked HGF plasmid tended to improve the resting pain and significantly decreased the size of the ischemic ulcer in the patients with CLI who did not have any alternative therapy, such as endovascular treatment (EVT) or bypass graft surgery. An HGF gene therapy product, CollategeneTM, was recently launched with conditional and time-limited approval in Japan to treat ischemic ulcer in patients with CLI. Further clinical trials would provide new therapeutic options for patients with CLI.",2020,"At 12 weeks after gene transfer, combined evaluation of VAS and ischemic ulcer size demonstrated a significant improvement in HGF gene therapy group as compared to placebo group (P=0.020).","['Japan', '22 patients with CLI in a single-center open trial at Osaka University; 39 patients in a randomized', 'patients with critical limb ischemia (CLI', 'patients with CLI', ""10 patients with Buerger's disease in a multi-center open trial; and 6 patients with""]","['HGF Gene Therapy', 'CLI', 'intramuscular HGF gene therapy', 'naked HGF plasmid at 2 mg or 4 mg', 'placebo']","['VAS score', 'size of the ischemic ulcer', 'Resting pain on a visual analogue scale (VAS) and wound healing', 'VAS and ischemic ulcer size', 'resting pain', 'peripheral edema', 'size of ischemic ulcer']","[{'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1142264', 'cui_str': 'Critical limb ischemia'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0040021', 'cui_str': 'Thromboangiitis obliterans'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}]","[{'cui': 'C0062534', 'cui_str': 'Scatter Factor'}, {'cui': 'C0017296', 'cui_str': 'Gene therapy'}, {'cui': 'C1142264', 'cui_str': 'Critical limb ischemia'}, {'cui': 'C0442117', 'cui_str': 'Intramuscular'}, {'cui': 'C0424470', 'cui_str': 'Undressed'}, {'cui': 'C0032136', 'cui_str': 'Plasmid'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0265000', 'cui_str': 'Ulcer of artery'}, {'cui': 'C0234253', 'cui_str': 'Rest pain'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0085649', 'cui_str': 'Peripheral edema'}]",10.0,0.0252449,"At 12 weeks after gene transfer, combined evaluation of VAS and ischemic ulcer size demonstrated a significant improvement in HGF gene therapy group as compared to placebo group (P=0.020).","[{'ForeName': 'Ryuichi', 'Initials': 'R', 'LastName': 'Morishita', 'Affiliation': 'Department of Clinical Gene Therapy, Graduate School of Medicine, Osaka University, Suita, Osaka, Japan.'}, {'ForeName': 'Munehisa', 'Initials': 'M', 'LastName': 'Shimamura', 'Affiliation': 'Department of Health Development and Medicine, Graduate School of Medicine, Osaka University, Suita, Osaka, Japan.'}, {'ForeName': 'Yasushi', 'Initials': 'Y', 'LastName': 'Takeya', 'Affiliation': 'Department of Geriatric Medicine, Graduate School of Medicine, Osaka University, Suita, Osaka, Japan.'}, {'ForeName': 'Hironori', 'Initials': 'H', 'LastName': 'Nakagami', 'Affiliation': 'Department of Health Development and Medicine, Graduate School of Medicine, Osaka University, Suita, Osaka, Japan.'}, {'ForeName': 'Mitsuaki', 'Initials': 'M', 'LastName': 'Chujo', 'Affiliation': 'AnGes Inc., Tokyo, Japan.'}, {'ForeName': 'Tetsuya', 'Initials': 'T', 'LastName': 'Ishihama', 'Affiliation': 'AnGes Inc., Tokyo, Japan.'}, {'ForeName': 'Ei', 'Initials': 'E', 'LastName': 'Yamada', 'Affiliation': 'AnGes Inc., Tokyo, Japan.'}, {'ForeName': 'Hiromi', 'Initials': 'H', 'LastName': 'Rakugi', 'Affiliation': 'Department of Geriatric Medicine, Graduate School of Medicine, Osaka University, Suita, Osaka, Japan.'}]",Current gene therapy,['10.2174/1566523220666200516171447'] 1367,31551136,The Effect of Hand Massage Before Cataract Surgery on Patient Anxiety and Comfort: A Randomized Controlled Study.,"PURPOSE This study aimed to determine the effectiveness of hand massage on patient anxiety and comfort before cataract surgery. DESIGN A randomized controlled trial. METHODS The 140 patients in this study were assigned to the intervention group (n = 70), which received a 10-minute hand massage before cataract surgery, and to the control group (n = 70), which received routine nursing care. The visual analog scale (VAS) and Spielberger State-Trait Anxiety Inventory (STAI) were used to collect data. FINDINGS The median STAI state scores of the intervention and control groups were found to be 46.0 (44.7 to 48.0) and 57.0 (55.75 to 59.00), respectively. The VAS comfort score of the intervention group after hand massage (4.0 [1.7-5.0]) was lower than that of the control group immediately before surgery (8.0 [6.0-10.0]) (P < .05). In addition, except oxygen saturation, the remaining vital signs were lower in the intervention group. CONCLUSIONS Hand massage reduced the anxiety of patients, positively affected their vital signs, and increased their comfort.",2020,The VAS comfort score of the intervention group after hand massage (4.0 [1.7-5.0]) was lower than that of the control group immediately before surgery (8.0 [6.0-10.0]) (P < .05).,['140 patients'],"['routine nursing care', 'Hand Massage Before Cataract Surgery', 'hand massage', '10-minute hand massage before cataract surgery']","['patient anxiety and comfort', 'VAS comfort score', 'Patient Anxiety and Comfort', 'median STAI state scores', 'visual analog scale (VAS) and Spielberger State-Trait Anxiety Inventory (STAI']","[{'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0028682', 'cui_str': 'Nursing Care'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0024875', 'cui_str': 'Massage'}, {'cui': 'C2004600', 'cui_str': 'Cataract surgery specialty'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}]",140.0,0.0424105,The VAS comfort score of the intervention group after hand massage (4.0 [1.7-5.0]) was lower than that of the control group immediately before surgery (8.0 [6.0-10.0]) (P < .05).,"[{'ForeName': 'Ayşe Uyar', 'Initials': 'AU', 'LastName': 'Çavdar', 'Affiliation': 'Department of Surgical Nursing, Institute of Health Science, Manisa Celal Bayar University, Manisa, Turkey.'}, {'ForeName': 'Emel', 'Initials': 'E', 'LastName': 'Yılmaz', 'Affiliation': 'Department of Surgical Nursing, Faculty of Health Science, Manisa Celal Bayar University, Manisa, Turkey. Electronic address: emelyilmazcbu@gmail.com.'}, {'ForeName': 'Hakan', 'Initials': 'H', 'LastName': 'Baydur', 'Affiliation': 'Department of Social Work, Faculty of Health Science, Manisa Celal Bayar University, Manisa, Turkey.'}]",Journal of perianesthesia nursing : official journal of the American Society of PeriAnesthesia Nurses,['10.1016/j.jopan.2019.06.012'] 1368,31553468,Association of Short-term Change in Leukocyte Telomere Length With Cortical Thickness and Outcomes of Mental Training Among Healthy Adults: A Randomized Clinical Trial.,"Importance Telomere length is associated with the development of age-related diseases and structural differences in multiple brain regions. It remains unclear, however, whether change in telomere length is linked to brain structure change, and to what extent telomere length can be influenced through mental training. Objectives To assess the dynamic associations between leukocyte telomere length (LTL) and cortical thickness (CT), and to determine whether LTL is affected by a longitudinal contemplative mental training intervention. Design, Setting, and Participants An open-label efficacy trial of three 3-month mental training modules with healthy, meditation-naive adults was conducted. Data on LTL and CT were collected 4 times over 9 months between April 22, 2013, and March 31, 2015, as part of the ReSource Project. Data analysis was performed between September 23, 2016, and June 21, 2019. Of 1582 eligible individuals, 943 declined to participate; 362 were randomly selected for participation and assigned to training or retest control cohorts, with demographic characteristics matched. The retest control cohorts underwent all testing but no training. Intention-to-treat analysis was performed. Interventions Training cohort participants completed 3 modules cultivating interoception and attention (Presence), compassion (Affect), or perspective taking (Perspective). Main Outcomes and Measures Change in LTL and CT. Results Of the 362 individuals randomized, 30 participants dropped out before study initiation (initial sample, 332). Data were available for analysis of the training intervention in 298 participants (n = 222 training; n = 76 retest control) (175 women [58.7%]; mean [SD] age, 40.5 [9.3] years). The training modules had no effect on LTL. In 699 observations from all 298 participants, mean estimated changes in the relative ratios of telomere repeat copy number to single-copy gene (T/S) were for no training, 0.004 (95% CI, -0.010 to 0.018); Presence, -0.007 (95% CI, -0.025 to 0.011); Affect, -0.005 (95% CI, -0.019 to 0.010); and Perspective, -0.001 (95% CI, -0.017 to 0.016). Cortical thickness change data were analyzed in 167 observations from 67 retest control participants (37 women [55.2%], mean [SD] age, 39.6 [9.0] years). In this retest control cohort subsample, naturally occurring LTL change was related to CT change in the left precuneus extending to the posterior cingulate cortex (mean t161 = 3.22; P < .001; r = 0.246). At the individual participant level, leukocyte telomere shortening as well as lengthening were observed. Leukocyte telomere shortening was related to cortical thinning (t77 = 2.38; P = .01; r = 0.262), and leukocyte telomere lengthening was related to cortical thickening (t77 = 2.42; P = .009; r = 0.266). All analyses controlled for age, sex, and body mass index. Conclusions and Relevance The findings of this trial indicate an association between short-term change in LTL and concomitant change in plasticity of the left precuneus extending to the posterior cingulate cortex. This result contributes to the evidence that LTL changes more dynamically on the individual level than previously thought. Further studies are needed to determine potential long-term implications of such change in relation to cellular aging and the development of neurodegenerative disorders. No effect of contemplative mental training was noted in what may be, to date, the longest intervention with healthy adults. Trial Registration ClinicalTrials.gov identifier: NCT01833104.",2019,"Leukocyte telomere shortening was related to cortical thinning (t77 = 2.38; P = .01; r = 0.262), and leukocyte telomere lengthening was related to cortical thickening (t77 = 2.42; P = .009; r = 0.266).","['Healthy Adults', 'with healthy, meditation-naive adults', '167 observations from 67 retest control participants (37 women [55.2', '1582 eligible individuals, 943 declined to participate; 362 were randomly selected for participation and assigned to training or retest control cohorts, with demographic characteristics matched', 'healthy adults', '298 participants (n\u2009=\u2009222 training; n\u2009=\u200976 retest control) (175 women [58.7%]; mean [SD] age, 40.5 [9.3] years', '30 participants dropped out before study initiation (initial sample, 332', '362 individuals randomized']","['mental training modules', 'contemplative mental training', 'Mental Training', 'Interventions\n\n\nTraining cohort participants completed 3 modules cultivating interoception and attention (Presence), compassion (Affect), or perspective taking (Perspective']","['LTL', 'leukocyte telomere length (LTL) and cortical thickness (CT', 'Measures\n\n\nChange in LTL and CT', 'relative ratios of telomere repeat copy number to single-copy gene (T/S', 'Cortical thickness change data', 'Leukocyte Telomere']","[{'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0150277'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4517595', 'cui_str': '167 (qualifier value)'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0543431', 'cui_str': 'ret (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C4517605', 'cui_str': '175'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4318619', 'cui_str': 'Drop (unit of presentation)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation (observable entity)'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}]","[{'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C3542953', 'cui_str': 'Module (core metadata concept)'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C3850156', 'cui_str': 'Interoception'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C1515187', 'cui_str': 'Take'}]","[{'cui': 'C0023516', 'cui_str': 'Blood Corpuscles, White'}, {'cui': 'C0085187'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C1264683', 'cui_str': 'Relative ratio'}, {'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0017337', 'cui_str': 'Genes'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]",298.0,0.0716763,"Leukocyte telomere shortening was related to cortical thinning (t77 = 2.38; P = .01; r = 0.262), and leukocyte telomere lengthening was related to cortical thickening (t77 = 2.42; P = .009; r = 0.266).","[{'ForeName': 'Lara M C', 'Initials': 'LMC', 'LastName': 'Puhlmann', 'Affiliation': 'Research Group, ""Social Stress and Family Health,"" Max Planck Institute for Human Cognitive and Brain Sciences, Leipzig, Germany.'}, {'ForeName': 'Sofie L', 'Initials': 'SL', 'LastName': 'Valk', 'Affiliation': 'Institute of Systems Neuroscience, Medical Faculty, Heinrich Heine University Düsseldorf, Düsseldorf, Germany.'}, {'ForeName': 'Veronika', 'Initials': 'V', 'LastName': 'Engert', 'Affiliation': 'Research Group, ""Social Stress and Family Health,"" Max Planck Institute for Human Cognitive and Brain Sciences, Leipzig, Germany.'}, {'ForeName': 'Boris C', 'Initials': 'BC', 'LastName': 'Bernhardt', 'Affiliation': 'Montreal Neurological Institute, McGill University, Montreal, Québec, Canada.'}, {'ForeName': 'Jue', 'Initials': 'J', 'LastName': 'Lin', 'Affiliation': 'Department of Biochemistry and Biophysics, University of California, San Francisco.'}, {'ForeName': 'Elissa S', 'Initials': 'ES', 'LastName': 'Epel', 'Affiliation': 'Department of Psychiatry, University of California, San Francisco.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Vrticka', 'Affiliation': 'Research Group, ""Social Stress and Family Health,"" Max Planck Institute for Human Cognitive and Brain Sciences, Leipzig, Germany.'}, {'ForeName': 'Tania', 'Initials': 'T', 'LastName': 'Singer', 'Affiliation': 'Social Neuroscience Lab, Max Planck Society, Berlin, Germany.'}]",JAMA network open,['10.1001/jamanetworkopen.2019.9687'] 1369,24773572,Latent growth modeling with domain-specific outcomes comprised of mixed response types in intervention studies.,"OBJECTIVE When several continuous outcome measures of interest are collected across time in experimental studies, the use of standard statistical procedures, such as multivariate analysis of variance or growth curve modeling, can be properly used to assess treatment effects. However, when data consist of mixed responses (e.g., continuous and ordered categorical [ordinal] responses), traditional modeling approaches are no longer appropriate. The purpose of this article is to illustrate the use of a more suitable modeling procedure when mixed responses are collected in longitudinal intervention studies. METHOD Problems with traditional analyses of such data are discussed, as are potential advantages provided by the proposed modeling approach. The application of the multiple-domain latent growth modeling approach with mixed responses is illustrated for experimental designs with data from the SeniorWISE study (McDougall et al., 2010). This multisite randomized trial assessed memory functioning of 265 elderly adults across a 26-month period after receiving either a memory or health promotion training program. RESULTS The latent growth models illustrated allow one to examine treatment effects on the growth of multiple mixed outcomes while incorporating associations among multiple responses, which allows for better missing data treatment, greater power, and more accurate control of Type I error. The interpretation of parameters of interest and treatment effects is discussed using the SeniorWISE data. CONCLUSIONS Multiple-domain latent growth modeling with mixed responses is a flexible statistical modeling tool that can have substantial benefits for applied researchers. As such, the use of this modeling approach is expected to increase.",2014,"The latent growth models illustrated allow one to examine treatment effects on the growth of multiple mixed outcomes while incorporating associations among multiple responses, which allows for better missing data treatment, greater power, and more accurate control of Type I error.",['265 elderly adults across a 26-month period after receiving either a memory or health promotion training program'],[],[],"[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0018738', 'cui_str': 'Health Promotion'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]",[],[],265.0,0.0178206,"The latent growth models illustrated allow one to examine treatment effects on the growth of multiple mixed outcomes while incorporating associations among multiple responses, which allows for better missing data treatment, greater power, and more accurate control of Type I error.","[{'ForeName': 'Tiffany A', 'Initials': 'TA', 'LastName': 'Whittaker', 'Affiliation': 'Department of Educational Psychology, University of Texas at Austin.'}, {'ForeName': 'Keenan A', 'Initials': 'KA', 'LastName': 'Pituch', 'Affiliation': 'Department of Educational Psychology, University of Texas at Austin.'}, {'ForeName': 'Graham J', 'Initials': 'GJ', 'LastName': 'McDougall', 'Affiliation': 'The University of Alabama Capstone College of Nursing.'}]",Journal of consulting and clinical psychology,['10.1037/a0036664'] 1370,32416538,"Peer outreach point-of-care testing as a bridge to hepatitis C care for people who inject drugs in Toronto, Canada.","BACKGROUND People who inject drugs have high rates of hepatitis C (HCV) and yet many remain undiagnosed and untreated. HCV treatment guidelines and elimination strategies recommend task-shifting to expand where, and by whom, HCV testing and care is delivered. METHODS A randomized controlled trial design was used to evaluate if point-of-care (POC) HCV antibody testing by peer outreach workers outside of health and social service spaces would improve engagement in HCV care. People with a lifetime history of injection drug use without prior knowledge of HCV antibody status were randomized to receive HCV outreach plus either POC or referral to community-based HCV program for testing as usual. The study was co-designed by people with lived experience of HCV. RESULTS 920 people were approached to participate over 14 weeks. After refusals, withdrawals and removal of duplicates, there were 380 study participants. Outreach took place primarily in public spaces (66%) such as parks, coffee shops and apartment lobbies. Participants reported very high rates of poverty, housing instability and recent injection drug use. Despite being at high risk for HCV, 61% had no history or knowledge of past HCV testing (n = 230). Of those who received a POC test 77/195 (39%) were positive for HCV antibodies. There was no change in rates of engagement in HCV care among those who received the POC (n = 6; 3%) compared to those who did not (n = 5; 3%). CONCLUSION Peer outreach workers were able to efficiently reach a marginalized group of individuals who had a high HCV antibody prevalence and low rates of prior HCV testing. This improved participants' knowledge of their HCV antibody status, but that knowledge in itself did not lead to any change in participant's subsequent engagement in HCV care. Future work is required to evaluate strategies such as incentives or peer navigators to improve linkage to HCV care after diagnosis.",2020,Peer outreach workers were able to efficiently reach a marginalized group of individuals who had a high HCV antibody prevalence and low rates of prior HCV testing.,"['people with lived experience of HCV', '920 people were approached to participate over 14 weeks', 'by peer outreach workers outside of health and social service spaces', 'People with a lifetime history of injection drug use without prior knowledge of HCV antibody status', 'people who inject drugs in Toronto, Canada']","['HCV outreach plus either POC or referral to community-based HCV program', 'care (POC) HCV antibody testing']",['rates of engagement in HCV care'],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0019196', 'cui_str': 'Viral hepatitis C'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0037441', 'cui_str': 'Social Service'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0449889', 'cui_str': 'Drug used'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0166049', 'cui_str': 'Antibody to hepatitis C virus'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C1720154', 'cui_str': 'Inject'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0006823', 'cui_str': 'Canada'}]","[{'cui': 'C0019196', 'cui_str': 'Viral hepatitis C'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0282664', 'cui_str': 'Point-of-Care'}, {'cui': 'C2585021', 'cui_str': 'Referral to'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0166049', 'cui_str': 'Antibody to hepatitis C virus'}, {'cui': 'C0392366', 'cui_str': 'Tests'}]","[{'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0019196', 'cui_str': 'Viral hepatitis C'}]",920.0,0.0380034,Peer outreach workers were able to efficiently reach a marginalized group of individuals who had a high HCV antibody prevalence and low rates of prior HCV testing.,"[{'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Broad', 'Affiliation': 'South Riverdale Community Health Centre, 955 Queen St East, Toronto, ON, M4M 3P3, Canada.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Mason', 'Affiliation': 'South Riverdale Community Health Centre, 955 Queen St East, Toronto, ON, M4M 3P3, Canada.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Guyton', 'Affiliation': 'Sherbourne Health, 333 Sherbourne St, Toronto, ON M5A 2S5, Canada.'}, {'ForeName': 'Bernadette', 'Initials': 'B', 'LastName': 'Lettner', 'Affiliation': 'South Riverdale Community Health Centre, 955 Queen St East, Toronto, ON, M4M 3P3, Canada; Regent Park Community Health Centre, 465 Dundas St East, Toronto, ON M5A 2B2, Canada.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Matelski', 'Affiliation': 'University Health Network, 235 - 200 Elizabeth St, Toronto, ON M5G 2C4, Canada.'}, {'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Powis', 'Affiliation': 'Michael Garron Hospital, 825 Coxwell Ave, Toronto, ON M4C 3E7, Canada. Electronic address: jeff.powis@tehn.ca.'}]",The International journal on drug policy,['10.1016/j.drugpo.2020.102755'] 1371,31821221,Feasibility and Acceptability of a Lifestyle Intervention For Individuals With Bipolar Disorder.,"Individuals with bipolar disorder are at greater risk for cardiovascular disease and are less likely to adhere to lifestyle interventions than the general population. To decrease cardiovascular risk and improve adherence to lifestyle interventions, we developed the Nutrition Exercise and Wellness Treatment (NEW Tx). NEW Tx is an 18-session, 20-week cognitive behavioral therapy-based treatment comprising 3 modules: Nutrition, Exercise, and Wellness. To evaluate the feasibility and acceptability of this intervention as well as predictors of treatment satisfaction and expectations, 38 adult outpatients with bipolar disorder were randomized to either NEW Tx or a waitlist control condition. There was no statistically significant difference in dropout rates between the groups (26.3% in NEW Tx, 31.6% in the control condition). In the NEW Tx condition, participants attended a mean of 66.7% of sessions and reported moderate to high satisfaction. There were no study-related adverse events. We also found that expectations, but not perceived credibility (or believability), of NEW Tx (as measured by the Credibility/Expectancy Questionnaire) at baseline predicted treatment satisfaction (as measured by the Care Satisfaction Questionnaire) posttreatment. Manic symptoms at baseline predicted treatment satisfaction, and marital status predicted one's expectations of lifestyle interventions. Data suggest that NEW Tx is a feasible and acceptable intervention for individuals with bipolar disorder and that further research is warranted to explore potential moderators of treatment expectations and credibility in this clinical population.",2019,"There was no statistically significant difference in dropout rates between the groups (26.3% in NEW Tx, 31.6% in the control condition).","['individuals with bipolar disorder', 'Individuals With Bipolar Disorder', 'Individuals with bipolar disorder', '38 adult outpatients with bipolar disorder']","['Lifestyle Intervention', 'NEW Tx or a waitlist control condition']","['Manic symptoms', 'perceived credibility (or believability), of NEW Tx (as measured by the Credibility/Expectancy Questionnaire', 'Feasibility and Acceptability', 'feasibility and acceptability', 'cardiovascular risk', 'dropout rates']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0005586', 'cui_str': 'Psychosis, Manic-Depressive'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}]","[{'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C0338831', 'cui_str': 'Manic State'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}]",38.0,0.0232546,"There was no statistically significant difference in dropout rates between the groups (26.3% in NEW Tx, 31.6% in the control condition).","[{'ForeName': 'Louisa G', 'Initials': 'LG', 'LastName': 'Sylvia', 'Affiliation': ""SYLVIA, ELLARD, NIERENBERG, DECKERSBACH: Massachusetts General Hospital and Harvard Medical School, Boston, MA JANOS, WALSH, DUFOUR, DAVIS: Massachusetts General Hospital, Boston, MA CHANG: Women's Treatment Program, McLean Hospital, Belmont, MA BERNSTEIN: Harvard University, Cambridge, MA.""}, {'ForeName': 'Jessica A', 'Initials': 'JA', 'LastName': 'Janos', 'Affiliation': ''}, {'ForeName': 'Samantha L', 'Initials': 'SL', 'LastName': 'Pegg', 'Affiliation': ''}, {'ForeName': 'Steven C', 'Initials': 'SC', 'LastName': 'Dufour', 'Affiliation': ''}, {'ForeName': 'Weilynn C', 'Initials': 'WC', 'LastName': 'Chang', 'Affiliation': ''}, {'ForeName': 'Emily E', 'Initials': 'EE', 'LastName': 'Bernstein', 'Affiliation': ''}, {'ForeName': 'Brett', 'Initials': 'B', 'LastName': 'Davis', 'Affiliation': ''}, {'ForeName': 'Kristen K', 'Initials': 'KK', 'LastName': 'Ellard', 'Affiliation': ''}, {'ForeName': 'Thilo', 'Initials': 'T', 'LastName': 'Deckersbach', 'Affiliation': ''}, {'ForeName': 'Andrew A', 'Initials': 'AA', 'LastName': 'Nierenberg', 'Affiliation': ''}]",Journal of psychiatric practice,['10.1097/PRA.0000000000000426'] 1372,31281625,Multicentre randomised controlled trial comparing standard and high resolution optical technologies in colorectal cancer screening.,"Background and objectives The UK bowel cancer screening programme (BCSP) has been established for the early detection of colorectal cancer offering colonoscopy to patients screened positive by faecal occult blood tests. In this multisite, prospective, randomised controlled trial, we aimed to compare the performance of Standard Definition Olympus Lucera (SD-OL) with Scope Guide and the High Definition Pentax HiLine (HD-PHL). Patients and methods Subjects undergoing a colonoscopy as part of the UK National BCSP at four UK sites were randomised to an endoscopy list run using either SD-OL or HD-PHL. Primary endpoints were polyp and adenoma detection rate (PDR and ADR, respectively) as well as polyp size, morphology and histology characteristics. Results 262 subjects (168 males, mean age 66.3±4.3 years) were colonoscoped (133 patients with HD-PHL while 129 with SD-OL). PDR and ADR were comparable within the two optical systems. The HD-PHL group resulted in a PDR 55.6% and ADR 43.6%; the SD-OL group had PDR 56.6% and ADR 45.7%. HD-PHL was significantly superior to SD-OL in detection of flat adenomas (18.6% vs 5.2%, p<0.001), but not detection of pedunculated or sessile polyps. Patient comfort, use of sedation and endoscopist perception of procedural difficulty resulted similar despite the use of Scope Guide with SD-OL. Conclusion PDR and ADR were not significantly different between devices. The high-resolution colonoscopy system HD-PHL may improve polyp detection as compared with standard resolution technology in detecting flat adenomas. This advantage may have clinically significant implications for missed lesion rates and post-colonoscopy interval colorectal cancer rates.",2019,"Patient comfort, use of sedation and endoscopist perception of procedural difficulty resulted similar despite the use of Scope Guide with SD-OL. Conclusion PDR and ADR were not significantly different between devices.","['colorectal cancer screening', 'Patients and methods\n\n\nSubjects undergoing a colonoscopy as part of the UK National BCSP at four UK sites', '262 subjects (168 males, mean age 66.3±4.3 years) were colonoscoped (133 patients with HD-PHL while 129 with SD-OL']","['UK bowel cancer screening programme (BCSP', 'endoscopy list run using either SD-OL or HD-PHL', 'standard and high resolution optical technologies', 'Standard Definition Olympus Lucera (SD-OL) with Scope Guide and the High Definition Pentax HiLine (HD-PHL']","['polyp and adenoma detection rate (PDR and ADR, respectively) as well as polyp size, morphology and histology characteristics', 'PDR and ADR']","[{'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0009378', 'cui_str': 'Endoscopy of colon'}, {'cui': 'C1292711', 'cui_str': 'Part of (attribute)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C4319556', 'cui_str': 'One hundred and sixty-eight'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0180022', 'cui_str': 'Colonoscopes'}, {'cui': 'C4517563', 'cui_str': '133'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C0346627', 'cui_str': 'Cancer of Intestines'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0600140', 'cui_str': 'Does run (finding)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C3539107', 'cui_str': 'Definition (core metadata concept)'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}]","[{'cui': 'C0032584', 'cui_str': 'Polyp (morphologic abnormality)'}, {'cui': 'C0001430', 'cui_str': 'Adenoma'}, {'cui': 'C0449207', 'cui_str': 'ADR (body structure)'}, {'cui': 'C1299212', 'cui_str': 'Polyp size'}, {'cui': 'C0543482', 'cui_str': 'morphology'}, {'cui': 'C0344441', 'cui_str': 'Histologic test (procedure)'}]",133.0,0.192044,"Patient comfort, use of sedation and endoscopist perception of procedural difficulty resulted similar despite the use of Scope Guide with SD-OL. Conclusion PDR and ADR were not significantly different between devices.","[{'ForeName': 'Simona', 'Initials': 'S', 'LastName': 'Di Caro', 'Affiliation': 'GI Services, University College London Hospitals NHS Foundation Trust, London, UK.'}, {'ForeName': 'Lucia', 'Initials': 'L', 'LastName': 'Fini', 'Affiliation': 'Department of Internal Medicine, Gastroenterology and Digestive Endoscopy Unit, Ospedale di Busto Arsizio, Busto Arsizio, Italy.'}, {'ForeName': 'Roser', 'Initials': 'R', 'LastName': 'Vega', 'Affiliation': 'GI Services, University College London Hospitals NHS Foundation Trust, London, UK.'}, {'ForeName': 'Konstantinos C', 'Initials': 'KC', 'LastName': 'Fragkos', 'Affiliation': 'GI Services, University College London Hospitals NHS Foundation Trust, London, UK.'}, {'ForeName': 'Sunil', 'Initials': 'S', 'LastName': 'Dolwani', 'Affiliation': 'Gastroenterology, Cardiff and Vale NHS Trust, Cardiff, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Green', 'Affiliation': 'Gastroenterology, Cardiff and Vale NHS Trust, Cardiff, UK.'}, {'ForeName': 'Lesley-Ann', 'Initials': 'LA', 'LastName': 'Smith', 'Affiliation': 'Department of Gastroenterology, Bradford Teaching Hospitals NHS Foundation Trust, Bradford, UK.'}, {'ForeName': 'Conrad', 'Initials': 'C', 'LastName': 'Beckett', 'Affiliation': 'Department of Gastroenterology, Bradford Teaching Hospitals NHS Foundation Trust, Bradford, UK.'}, {'ForeName': 'Ewen', 'Initials': 'E', 'LastName': 'Cameron', 'Affiliation': ""Department of Gastroenterology, Addenbrooke's Hospital, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK.""}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Banks', 'Affiliation': 'GI Services, University College London Hospitals NHS Foundation Trust, London, UK.'}]",Frontline gastroenterology,['10.1136/flgastro-2018-101130'] 1373,26324355,Palbociclib: A Novel Cyclin-Dependent Kinase Inhibitor for Hormone Receptor-Positive Advanced Breast Cancer.,"OBJECTIVE To review palbociclib, a novel small-molecule inhibitor of cyclin-dependent kinases 4 and 6, and its current place in therapy for the treatment of hormone receptor (HMR)-positive, human epidermal growth factor receptor 2 (Her2)-negative advanced breast cancer. STUDY SELECTION AND DATA ABSTRACTION Four phase I trials, 2 phase II trials, and 1 phase III trial were identified from May 2004 to May 2015 using PubMed, American Society of Clinical Oncology (ASCO) abstracts, and European Society of Medical Oncology (ESMO) abstracts. DATA SYNTHESIS In the first-line setting, the phase II PALbociclib: Ongoing trials in the Management of breast cAncer (PALOMA)-1 trial randomized patients to receive letrozole alone or letrozole plus palbociclib 125 mg daily for 3 weeks, followed by 1 week off, as initial therapy for advanced breast cancer. The investigator-assessed median progression-free survival (PFS) was 20. 2 months for the combination versus 10.2 months for letrozole alone (hazard ratio [HR] = 0.488; 95% CI = 0.319-0.748; 1-sided P = 0.0004). The ensuing Food and Drug Administration approval of palbociclib was given a ""breakthrough therapy"" designation, where preliminary evidence suggests substantial improvement over existing therapies for a serious or life-threatening disease. A confirmatory phase III trial, PALOMA-2, is under way. In patients who were previously treated with endocrine therapy for advanced breast cancer, the phase III PALOMA-3 trial randomized patients to fulvestrant plus palbociclib versus fulvestrant plus placebo. The investigator-assessed median PFS at the time of a preplanned analysis was 9.2 months with palbociclib-fulvestrant compared with 3.8 months with placebo-fulvestrant (HR = 0.42; 95% CI = 0.32-0.56; P < 0.001). CONCLUSIONS Palbociclib, the first-in-class CDK4/6 inhibitor, significantly extended PFS in combination with endocrine therapy in the first and subsequent lines of treatment for HMR-positive, Her2-negative advanced breast cancer.",2015,The investigator-assessed median progression-free survival (PFS) was 20.,"['patients who were previously treated with endocrine therapy for advanced breast cancer', 'Four phase I trials, 2 phase II trials, and 1 phase III trial were identified from May 2004 to May 2015 using PubMed, American Society of Clinical Oncology (ASCO) abstracts, and European Society of Medical Oncology (ESMO) abstracts', 'advanced breast cancer']","['endocrine therapy', 'Novel Cyclin-Dependent Kinase Inhibitor', 'placebo-fulvestrant', 'fulvestrant plus palbociclib versus fulvestrant plus placebo', 'letrozole', 'Palbociclib', 'letrozole alone or letrozole plus palbociclib']","['median PFS', 'median progression-free survival (PFS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy (procedure)'}, {'cui': 'C3495917', 'cui_str': 'Advanced breast cancer'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C1274034', 'cui_str': 'Clinical Oncology'}, {'cui': 'C0600678', 'cui_str': 'Abstracts'}, {'cui': 'C0239307', 'cui_str': 'European (ethnic group)'}, {'cui': 'C0025098', 'cui_str': 'Medical Oncology'}]","[{'cui': 'C0279025', 'cui_str': 'Hormone therapy (procedure)'}, {'cui': 'C0243045', 'cui_str': 'cdk Proteins'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0935916', 'cui_str': 'fulvestrant'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C3853822', 'cui_str': 'palbociclib'}, {'cui': 'C0246421', 'cui_str': 'letrozole'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",,0.0577338,The investigator-assessed median progression-free survival (PFS) was 20.,"[{'ForeName': 'Neha S', 'Initials': 'NS', 'LastName': 'Mangini', 'Affiliation': 'The James Cancer Hospital at the Ohio State University, Columbus, OH, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Wesolowski', 'Affiliation': 'The Ohio State University Comprehensive Cancer Center, Columbus, OH, USA.'}, {'ForeName': 'Bhuvaneswari', 'Initials': 'B', 'LastName': 'Ramaswamy', 'Affiliation': 'The Ohio State University Comprehensive Cancer Center, Columbus, OH, USA.'}, {'ForeName': 'Maryam B', 'Initials': 'MB', 'LastName': 'Lustberg', 'Affiliation': 'The Ohio State University Comprehensive Cancer Center, Columbus, OH, USA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Berger', 'Affiliation': 'The James Cancer Hospital at the Ohio State University, Columbus, OH, USA michael.berger@osumc.edu.'}]",The Annals of pharmacotherapy,['10.1177/1060028015602273'] 1374,31549903,Use of a Bidirectional Text Messaging System for Emergency Department Follow-Up Versus Usual Follow-Up.,"Background: The use of text messaging is a growing trend. Usual care for follow-up with patients (no dedicated communication) has proven unreliable, and alternative communication methods may be beneficial. Introduction: The objective was to evaluate the effect of text messaging as a means of follow-up communication compared to usual care on patient satisfaction among patients discharged from the emergency department (ED). Materials and Methods: Participants completed a baseline survey about their text message usage and ED visit satisfaction. The participants completed a follow-up survey 2 weeks later. Participants randomized to text messaging received a text message at 24 h, 1 week, and 2 weeks after discharge. Control participants received usual care (typically no dedicated communication). Bivariate analyses were performed, and intent-to-treat and per protocol analyses were completed to examine follow-up satisfaction with ED communication/care. Results: A total of 802 subjects were recruited (text messaging-398 subjects, usual care-404 subjects). In the intent-to-treat analysis, text messaging subjects were not more likely to report satisfaction with follow-up communication (adjusted odds ratio [aOR] 0.90 [0.46-1.75]) or follow-up care (aOR 0.66 [0.30-1.46]) than usual care subjects. In per-protocol analysis, text messaging subjects had 2.95 (1.52-5.73) higher odds of reporting satisfaction with follow-up communication and 3.24 (1.46-7.16) higher odds of reporting satisfaction with follow-up care. Discussion: The use of text messaging for follow-up, when comparing satisfaction with follow-up communication and follow-up care after discharge, performs at least equally as well as usual follow-up. Conclusions: Text messaging is a provider time-saving and resource-conserving technology allowing health care providers to potentially reach a larger proportion of patients, making it a valuable form of follow-up communication.",2020,"In the intent-to-treat analysis, text messaging subjects were not more likely to report satisfaction with follow-up communication (adjusted odds ratio [aOR] 0.90 [0.46-1.75]) or follow-up care (aOR 0.66 [0.30-1.46]) than usual care subjects.","['patients discharged from the emergency department (ED', '802 subjects were recruited (text messaging-398 subjects, usual care-404 subjects']","['Bidirectional Text Messaging System', 'usual care (typically no dedicated communication', 'text messaging']",[],"[{'cui': 'C0030685', 'cui_str': 'Patient Discharge'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C3178908', 'cui_str': 'Texting'}]","[{'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0009452', 'cui_str': 'Communication'}]",[],802.0,0.0576994,"In the intent-to-treat analysis, text messaging subjects were not more likely to report satisfaction with follow-up communication (adjusted odds ratio [aOR] 0.90 [0.46-1.75]) or follow-up care (aOR 0.66 [0.30-1.46]) than usual care subjects.","[{'ForeName': 'Brooks J', 'Initials': 'BJ', 'LastName': 'Obr', 'Affiliation': 'Department of Emergency Medicine, Carver College of Medicine, University of Iowa, Iowa City, Iowa, USA.'}, {'ForeName': 'Tracy', 'Initials': 'T', 'LastName': 'Young', 'Affiliation': 'Department of Emergency Medicine, Carver College of Medicine, University of Iowa, Iowa City, Iowa, USA.'}, {'ForeName': 'Karisa K', 'Initials': 'KK', 'LastName': 'Harland', 'Affiliation': 'Department of Emergency Medicine, Carver College of Medicine, University of Iowa, Iowa City, Iowa, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Nugent', 'Affiliation': 'Department of Emergency Medicine, Carver College of Medicine, University of Iowa, Iowa City, Iowa, USA.'}]",Telemedicine journal and e-health : the official journal of the American Telemedicine Association,['10.1089/tmj.2019.0002'] 1375,25827253,Self-directed physical activity intervention in older adults undergoing adjuvant chemotherapy for colorectal cancer: Design of a randomized controlled trial.,"BACKGROUND Colorectal cancer (CRC) diagnosis and treatment can have substantial detrimental impacts on health related quality of life (HRQOL) and physical function. This is especially true for older CRC patients and is of paramount concern in chemotherapy treatment decision making; yet, few studies to date have focused on understanding and managing fatigue in older CRC patients. We present the design of a study to evaluate the feasibility and impact of a home-based, self-directed physical activity intervention on fatigue in older CRC patients receiving adjuvant chemotherapy treatment. Secondary aims pertain to intervention impact on HRQOL, physical function, and self-efficacy for managing fatigue. METHODS/DESIGN Multi-site, randomized controlled trial of physical activity intervention compared to usual care in a sample of older adults undergoing adjuvant chemotherapy for CRC. Forty CRC patients will be recruited and study questionnaires/assessments will be performed at baseline, 3 months, and after completion of adjuvant chemotherapy. The primary outcome is a comparison of the change in fatigue from baseline to 3 months between Intervention and Control arms. We will also compare changes in engagement in physical activity, HRQOL, physical function, and self-efficacy. Exploratory analyses will compare Intervention and Control arms with regard to changes in muscle mass and a biomarker aging that is known to increase during chemotherapy (p16(INK4a)). DISCUSSION If positive, findings from this pilot study would suggest the potential for improving the care of older persons with CRC undergoing adjuvant chemotherapy through a home-based physical activity intervention to manage fatigue, HRQOL, and physical function. TRIAL REGISTRATION NCT02191969.",2015,"Exploratory analyses will compare Intervention and Control arms with regard to changes in muscle mass and a biomarker aging that is known to increase during chemotherapy (p16(INK4a)). ","['older CRC patients receiving adjuvant chemotherapy treatment', 'older adults undergoing adjuvant chemotherapy for colorectal cancer', 'older CRC patients', 'Forty CRC patients', 'older persons with CRC undergoing', 'older adults undergoing adjuvant chemotherapy for CRC']","['Self-directed physical activity intervention', 'adjuvant chemotherapy', 'home-based, self-directed physical activity intervention', 'usual care', 'physical activity intervention']","['change in fatigue', 'physical activity, HRQOL, physical function, and self-efficacy', 'HRQOL, physical function, and self-efficacy']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0170127', 'cui_str': 'Calcibiotic Root Canal Sealer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C0027361', 'cui_str': 'Persons'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}]",40.0,0.105522,"Exploratory analyses will compare Intervention and Control arms with regard to changes in muscle mass and a biomarker aging that is known to increase during chemotherapy (p16(INK4a)). ","[{'ForeName': 'Grant R', 'Initials': 'GR', 'LastName': 'Williams', 'Affiliation': 'UNC Lineberger Comprehensive Cancer Center 450 West Drive, Chapel Hill, NC 27514, United States; Department of Medicine, Division of Hematology-Oncology, University of North Carolina at Chapel Hill, NC 27599, United States. Electronic address: grwillia@unch.unc.edu.'}, {'ForeName': 'Kirsten A', 'Initials': 'KA', 'LastName': 'Nyrop', 'Affiliation': 'UNC Lineberger Comprehensive Cancer Center 450 West Drive, Chapel Hill, NC 27514, United States; Department of Medicine, Division of Hematology-Oncology, University of North Carolina at Chapel Hill, NC 27599, United States.'}, {'ForeName': 'Allison M', 'Initials': 'AM', 'LastName': 'Deal', 'Affiliation': 'UNC Lineberger Comprehensive Cancer Center 450 West Drive, Chapel Hill, NC 27514, United States.'}, {'ForeName': 'Hyman B', 'Initials': 'HB', 'LastName': 'Muss', 'Affiliation': 'UNC Lineberger Comprehensive Cancer Center 450 West Drive, Chapel Hill, NC 27514, United States; Department of Medicine, Division of Hematology-Oncology, University of North Carolina at Chapel Hill, NC 27599, United States.'}, {'ForeName': 'Hanna K', 'Initials': 'HK', 'LastName': 'Sanoff', 'Affiliation': 'UNC Lineberger Comprehensive Cancer Center 450 West Drive, Chapel Hill, NC 27514, United States; Department of Medicine, Division of Hematology-Oncology, University of North Carolina at Chapel Hill, NC 27599, United States.'}]",Contemporary clinical trials,['10.1016/j.cct.2015.03.008'] 1376,31022102,Tobacco Evidence-Based Practice Implementation and Employee Tobacco-Related Outcomes at Small Low-Wage Worksites.,"OBJECTIVE The aim of this study was to assess whether tobacco policy, program, and communication evidence-based practice implementation is associated with employee tobacco outcomes [current smoking; quit attempt; smokeless tobacco (SLT) use; and perceived worksite support for cessation] at small low-wage worksites. METHODS We analyzed data from a randomized controlled trial testing an intervention to increase implementation of evidence-based health promotion practices. We used generalized estimating equations to examine relationships between practice implementation and tobacco outcomes. RESULTS Communication practice implementation was associated with better perceived worksite support for cessation (P = 0.027). Policy and program implementation were associated with increased odds of being a current SLT user; these findings should be interpreted with caution given small sample sizes. CONCLUSION Tobacco communication evidence-based practice implementation was associated with favorable perceptions of worksite support for cessation; more may be needed to change tobacco use behavior.",2019,"RESULTS Communication practice implementation was associated with better perceived worksite support for cessation (P = 0.027).",[],[],[],[],[],[],,0.15325,"RESULTS Communication practice implementation was associated with better perceived worksite support for cessation (P = 0.027).","[{'ForeName': 'Christine M', 'Initials': 'CM', 'LastName': 'Kava', 'Affiliation': 'Health Promotion Research Center, Department of Health Services, University of Washington, Seattle, Washington (Dr Kava, Dr Harris, Ms Kohn, Ms Parrish, Dr Hannon), and Department of Biostatistics, University of Washington, Seattle, Washington (Dr Gary Chan).'}, {'ForeName': 'Jeffrey R', 'Initials': 'JR', 'LastName': 'Harris', 'Affiliation': ''}, {'ForeName': 'Kwun C', 'Initials': 'KC', 'LastName': 'Gary Chan', 'Affiliation': ''}, {'ForeName': 'Marlana J', 'Initials': 'MJ', 'LastName': 'Kohn', 'Affiliation': ''}, {'ForeName': 'Amanda T', 'Initials': 'AT', 'LastName': 'Parrish', 'Affiliation': ''}, {'ForeName': 'Peggy A', 'Initials': 'PA', 'LastName': 'Hannon', 'Affiliation': ''}]",Journal of occupational and environmental medicine,['10.1097/JOM.0000000000001618'] 1377,31549793,Baseline Objective Inflammation by Magnetic Resonance Imaging as a Predictor of Therapeutic Benefit in Early Rheumatoid Arthritis With Poor Prognosis.,"OBJECTIVE High magnetic resonance imaging (MRI)-detected inflammation is associated with greater progression and poorer outcomes in rheumatoid arthritis (RA). This analysis aimed to determine if baseline MRI inflammation was related to clinical response and remission in the Assessing Very Early Rheumatoid arthritis Treatment (AVERT) study. METHODS AVERT was a phase IIIb, randomized, controlled trial with a 12-month, double-blind treatment period enrolling patients with early (≤2 years' duration), anti-citrullinated peptide-positive methotrexate (MTX)-naive RA. In this post hoc analysis, patients in the abatacept plus MTX (n = 114) and MTX (n = 111) arms with available MRI results were stratified into low and high baseline MRI inflammation groups based on previously developed cutoffs of synovitis and osteitis on unilateral hand-wrist contrast-enhanced MRI. Simplified Disease Activity Index (SDAI) remission (≤3.3), Clinical Disease Activity Index (CDAI) remission (≤2.8), Boolean remission, and Disease Activity Score in 28 joints using the C-reactive protein level (<2.6) were assessed. RESULTS Overall, 100 of 225 patients (44.4%) had high baseline MRI inflammation. In patients with high baseline MRI inflammation, a significantly greater proportion achieved remission at 12 months with abatacept plus MTX versus MTX across SDAI (45.1% versus 16.3%; P = 0.0022), CDAI (47.1% versus 20.4%; P = 0.0065), and Boolean indices (39.2% versus 16.3%; P = 0.0156). In patients with low baseline MRI inflammation, remission rates were not significantly different with abatacept plus MTX versus MTX (SDAI: 39.7% versus 32.3%; P = 0.4961). CONCLUSION In seropositive, MTX-naive patients with early RA and presence of objectively measured high inflammation by MRI, indicating poor prognosis, remission rates were higher with abatacept plus MTX treatment versus MTX.",2020,"Simplified Disease Activity Index (SDAI) remission (≤3.3), Clinical Disease Activity Index (CDAI) remission (≤2.8), Boolean remission, and Disease Activity Score in 28 joints (C-reactive protein)","[""enrolling patients with early (≤2 years' duration), anti-citrullinated peptide-positive methotrexate (MTX)-naïve RA""]","['MTX', 'abatacept+MTX treatment versus MTX', 'Magnetic Resonance Imaging', 'magnetic resonance imaging', 'abatacept+MTX versus MTX', 'abatacept+MTX']","['Simplified Disease Activity Index (SDAI) remission (≤3.3), Clinical Disease Activity Index (CDAI) remission (≤2.8), Boolean remission, and Disease Activity Score', 'remission rates', 'Boolean indices', 'CDAI', 'remission']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0030956', 'cui_str': 'Peptides'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1552358', 'cui_str': 'Magnetic resonance imaging'}]","[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C4706353', 'cui_str': 'Disease Activity Score'}]",,0.295007,"Simplified Disease Activity Index (SDAI) remission (≤3.3), Clinical Disease Activity Index (CDAI) remission (≤2.8), Boolean remission, and Disease Activity Score in 28 joints (C-reactive protein)","[{'ForeName': 'Harris A', 'Initials': 'HA', 'LastName': 'Ahmad', 'Affiliation': 'Bristol Myers Squibb, Princeton, New Jersey.'}, {'ForeName': 'Joshua F', 'Initials': 'JF', 'LastName': 'Baker', 'Affiliation': 'University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Mikkel', 'Initials': 'M', 'LastName': 'Østergaard', 'Affiliation': 'Rigshospitalet, Glostrup, Denmark, and University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Emery', 'Affiliation': 'University of Leeds and NIHR Leeds Biomedical Research Centre, Leeds, UK.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Durez', 'Affiliation': 'Université Catholique de Louvain, Brussels, Belgium.'}, {'ForeName': 'June', 'Initials': 'J', 'LastName': 'Ye', 'Affiliation': 'Bristol Myers Squibb, Princeton, New Jersey.'}, {'ForeName': 'Subhashis', 'Initials': 'S', 'LastName': 'Banerjee', 'Affiliation': 'Bristol Myers Squibb, Princeton, New Jersey.'}, {'ForeName': 'Philip G', 'Initials': 'PG', 'LastName': 'Conaghan', 'Affiliation': 'University of Leeds and NIHR Leeds Biomedical Research Centre, Leeds, UK.'}]",Arthritis care & research,['10.1002/acr.24072'] 1378,32417345,Randomized controlled trial to identify the optimal radiotherapy scheme for palliative treatment of incurable head and neck squamous cell carcinoma.,"BACKGROUND No randomized controlled trials (RCT) have yet identified the optimal palliative radiotherapy scheme in patients with incurable head and neck squamous cell carcinoma (HNSCC). We conducted RCT to compare two radiation schemes in terms of efficacy, toxicity and quality-of-life (QoL). MATERIALS AND METHODS Patients with locally-advanced HNSCC who were ineligible for radical treatment and those with limited metastatic disease were randomly assigned in 1:1 ratio to arm 1 (36 Gy in 6 fractions, twice a week) or arm 2 (50 Gy in 16 fractions, four times a week). RESULTS The trial was discontinued early because of slow accrual (34 patients enrolled). Objective response rates were 38.9% and 57.1% for arm 1 and 2 respectively (p = 0.476). The median time to loco-regional progression was not reached. The loco-regional control rates at 1 year was 57.4% and 69.3% in arm 1 and 2 (p = 0.450, HR = 0.56, 95%CI 0.12-2.58). One-year overall survival was 33.3% and 57.1%, with medians of 35.4 and 59.5 weeks, respectively (p = 0.215, HR = 0.55, 95%CI 0.21-1.43). Acute grade ≥3 toxicity was lower in arm 1 (16.7% versus 57.1%, p = 0.027), with the largest difference in grade 3 mucositis (5.6% versus 42.9%, p = 0.027). However, no significant deterioration in any of the patient-reported QoL-scales was found. CONCLUSION No solid conclusion could be made on this incomplete study which is closed early. Long-course radiotherapy did not show significantly better oncologic outcomes, but was associated with more acute grade 3 mucositis. No meaningful differences in QoL-scores were found. Therefore, the shorter schedule might be carefully advocated. However, this recommendation should be interpreted with great caution because of the inadequate statistical power.",2020,Objective response rates were 38.9% and 57.1% for arm 1 and 2 respectively (p=0.476).,"['patients with incurable head and neck squamous cell carcinoma (HNSCC', 'incurable head and neck squamous cell carcinoma', 'Patients with locally-advanced HNSCC who were ineligible for radical treatment and those with limited metastatic disease']",[],"['grade 3 mucositis', 'QoL-scores', 'efficacy, toxicity and quality-of-life (QoL', 'Acute grade ≥3 toxicity', 'median time to loco-regional progression', 'QoL-scales', 'overall survival', 'loco-regional control rates', 'acute grade 3 mucositis', 'oncologic outcomes', 'Objective response rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1168401', 'cui_str': 'Squamous cell carcinoma of head and neck'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0302912', 'cui_str': 'Radical'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}]",[],"[{'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0333355', 'cui_str': 'Inflammatory disease of mucous membrane'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0451401', 'cui_str': 'Quality of life scale'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205478', 'cui_str': 'Oncologic'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0018017', 'cui_str': 'Goal'}]",34.0,0.193028,Objective response rates were 38.9% and 57.1% for arm 1 and 2 respectively (p=0.476).,"[{'ForeName': 'Abrahim', 'Initials': 'A', 'LastName': 'Al-Mamgani', 'Affiliation': 'Department of Radiation Oncology, The Netherlands Cancer Institute, Amsterdam, the Netherlands. Electronic address: a.almamgani@nki.nl.'}, {'ForeName': 'Rob', 'Initials': 'R', 'LastName': 'Kessels', 'Affiliation': 'Department of Biometrics, The Netherlands Cancer Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'Cornelia G', 'Initials': 'CG', 'LastName': 'Verhoef', 'Affiliation': 'Department of Radiation Oncology, Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'Arash', 'Initials': 'A', 'LastName': 'Navran', 'Affiliation': 'Department of Radiation Oncology, The Netherlands Cancer Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Hamming-Vrieze', 'Affiliation': 'Department of Radiation Oncology, The Netherlands Cancer Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'Johannes H A M', 'Initials': 'JHAM', 'LastName': 'Kaanders', 'Affiliation': 'Department of Radiation Oncology, Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'Roel J H M', 'Initials': 'RJHM', 'LastName': 'Steenbakkers', 'Affiliation': 'Department of Radiation Oncology, University Medical Center Groningen, University of Groningen, the Netherlands.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Tans', 'Affiliation': 'Department of Radiation Oncology, Erasmus MC Cancer Institute, Rotterdam, the Netherlands.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Hoebers', 'Affiliation': 'Department of Radiation Oncology (MAASTRO Clinic), GROW - School for Oncology and Developmental Biology, Maastricht University Medical Center, The Netherlands.'}, {'ForeName': 'Francisca', 'Initials': 'F', 'LastName': 'Ong', 'Affiliation': 'Department of Radiation Oncology, Medisch Spectrum Twente, The Netherlands.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'van Werkhoven', 'Affiliation': 'Department of Biometrics, The Netherlands Cancer Institute, Amsterdam, the Netherlands.'}, {'ForeName': 'Johannes A', 'Initials': 'JA', 'LastName': 'Langendijk', 'Affiliation': 'Department of Radiation Oncology, University Medical Center Groningen, University of Groningen, the Netherlands.'}]",Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology,['10.1016/j.radonc.2020.05.020'] 1379,32417564,Sham Surgery Studies in Orthopaedic Surgery May Just Be a Sham: A Systematic Review of Randomized Placebo-Controlled Trials.,"PURPOSE To determine the limitations of randomized sham surgery-controlled trials in orthopaedic sports medicine and fidelity of the trials' conclusions. METHODS Randomized placebo surgery-controlled trials in orthopaedic sports medicine were included in this Preferred Reporting Items for Systematic Reviews and Meta-Analyses-guided systematic review. Several aspects of investigation design and conduct were analyzed: genetic analysis for propensity to placebo response, equipoise of informed consent process, geography of trial subjects, percentage of eligible subjects willing to be randomized, changes from protocol publication to results publication, and perioperative complications. RESULTS Seven sham surgery-controlled trials (845 subjects [370 knees, 449 shoulders, 26 elbows]; 5 from Europe, 1 from North America, and 1 from Australia; all superiority model, efficacy design) were analyzed. There were consistent methodologic deficiencies across studies. No studies reported genetic analysis of susceptibility to placebo response. Three studies (43%) were underpowered. Crossover rates ranged from 8% to 36%, which led to un-blinding in up to 100% of subjects. There were low enrollment rates of eligible subjects (up to 57% refused randomization). Follow-up was short term (2 years or less in all but one study). Complication rates ranged from 0% to 12.5%, with complications occurring in both groups (no significant difference between groups in any study). CONCLUSIONS Randomized sham-controlled studies in orthopaedic sports medicine have significant methodologic deficiencies that may invalidate their conclusions. Randomized trial design (with or without placebo control) may be optimized through the inclusion of per-protocol analysis, blinding index, equivalence or noninferiority trial design, and a nontreatment group. LEVEL OF EVIDENCE Level II Systematic Review of Level II studies.",2020,"Complication rates ranged from 0% to 12.5% with complications occurring in both groups (no significant difference between groups in any study). ","['orthopedic sports medicine', 'Seven sham surgery-controlled trials (845 subjects [370 knees, 449 shoulders, 26 elbows]; five Europe, one North America, one Australia', 'Orthopedic Surgery']","['Placebo', 'placebo']",['Complication rates'],"[{'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C0038040', 'cui_str': 'Medicine, Sport'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C4517743', 'cui_str': '370'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0013769', 'cui_str': 'Elbow region structure'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C0028405', 'cui_str': 'North America'}, {'cui': 'C0004340', 'cui_str': 'Australia'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0009566', 'cui_str': 'Complication'}]",845.0,0.715691,"Complication rates ranged from 0% to 12.5% with complications occurring in both groups (no significant difference between groups in any study). ","[{'ForeName': 'Kyle R', 'Initials': 'KR', 'LastName': 'Sochacki', 'Affiliation': 'Houston Methodist Orthopedic and Sports Medicine, Houston, Texas, U.S.A.'}, {'ForeName': 'Richard C', 'Initials': 'RC', 'LastName': 'Mather', 'Affiliation': 'Department of Orthopaedic Surgery, Duke University School of Medicine, Durham, North Carolina, U.S.A.'}, {'ForeName': 'Benedict U', 'Initials': 'BU', 'LastName': 'Nwachukwu', 'Affiliation': 'Hospital for Special Surgery, New York, New York, U.S.A.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Dong', 'Affiliation': 'Houston Methodist Orthopedic and Sports Medicine, Houston, Texas, U.S.A.'}, {'ForeName': 'Shane J', 'Initials': 'SJ', 'LastName': 'Nho', 'Affiliation': 'Section of Young Adult Hip Surgery, Division of Sports Medicine, Department of Orthopedic Surgery, Rush University Medical Center, Chicago, Illinois, U.S.A.'}, {'ForeName': 'Mark P', 'Initials': 'MP', 'LastName': 'Cote', 'Affiliation': 'UConn Musculoskeletal Institute at UConn Health, Farmington, Connecticut, U.S.A.'}, {'ForeName': 'Joshua D', 'Initials': 'JD', 'LastName': 'Harris', 'Affiliation': 'Houston Methodist Orthopedic and Sports Medicine, Houston, Texas, U.S.A.. Electronic address: joshuaharrismd@gmail.com.'}]",Arthroscopy : the journal of arthroscopic & related surgery : official publication of the Arthroscopy Association of North America and the International Arthroscopy Association,['10.1016/j.arthro.2020.05.001'] 1380,31135540,CORR Insights®: Small Social Incentives Did Not Improve the Survey Response Rate of Patients Who Underwent Orthopaedic Surgery: A Randomized Trial.,,2019,,[],"['Orthopaedic Surgery', 'CORR Insights®']",['Survey Response Rate'],[],"[{'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0038951', 'cui_str': 'Surveys'}]",,0.0460477,,"[{'ForeName': 'Mitesh S', 'Initials': 'MS', 'LastName': 'Patel', 'Affiliation': 'M. S. Patel, Assistant Professor, University of Pennsylvania; Staff Physician, CMC VA Medical Center, Philadelphia, PA, USA.'}]",Clinical orthopaedics and related research,['10.1097/CORR.0000000000000811'] 1381,26998789,Preventing Postpartum Smoking Relapse: A Randomized Clinical Trial.,"IMPORTANCE Most women who quit smoking during pregnancy will relapse postpartum. Previous efforts to prevent postpartum relapse have been unsuccessful at increasing rates of sustained abstinence. OBJECTIVE To evaluate the relative efficacy of 2 different approaches to prevent postpartum smoking relapse. DESIGN, SETTING, AND PARTICIPANTS Pregnant women who recently had quit smoking were recruited before the end of pregnancy. Intervention sessions were conducted through a combination of telephone calls and in-person visits beginning at delivery and continuing through 24 weeks postpartum. Participants completed assessments at the prenatal baseline and at 12, 24, and 52 weeks postpartum. Participants were recruited between March 2008 and December 2012. The dates of the analysis were April 2014 to February 2015. INTERVENTIONS Women received postpartum-adapted, behavioral smoking relapse prevention intervention and were randomly assigned to an enhanced cognitive behavioral intervention that included additional specialized strategies and content focused on women's postpartum concerns about mood, stress, and weight (Strategies to Avoid Returning to Smoking [STARTS]) or a supportive, time and attention-controlled comparison (SUPPORT). Intervention began before delivery and continued through 24 weeks postpartum. MAIN OUTCOMES AND MEASURES The primary outcome was biochemically confirmed sustained tobacco abstinence at 52 weeks postpartum. Secondary outcomes were self-reported mood, levels of perceived stress, and degree of concern about smoking-related weight gain. RESULTS The study cohort comprised 300 participants (150 randomly assigned to each group). Their mean (SD) age was 24.99 (5.65) years. Overall, 38.0% (114 of 300), 33.7% (101 of 300), and 24.0% (72 of 300) of the sample maintained abstinence at 12, 24, and 52 weeks' postpartum, respectively. There were no differences between the intervention groups in abstinence or time to relapse. Self-reported depressive symptoms and perceived stress significantly improved over time, and improvements were similar for both intervention groups. Women with more depressive symptoms and higher levels of perceived stress were more likely to relapse (hazard ratio, 1.02; 95% CI, 1.00-1.04; P = .04 for depressive symptoms and hazard ratio, 1.04; 95% CI, 1.01-1.07; P = .003 for stress). CONCLUSIONS AND RELEVANCE An intervention designed to address women's concerns about mood, stress, and weight did not differentially improve rates of sustained tobacco abstinence postpartum compared with a time and attention-controlled comparison. Women in STARTS and SUPPORT reported postpartum improvements in mood and stress, and the experience of fewer depressive symptoms and less perceived stress was related to sustained abstinence. Given that most pregnant quitters will relapse within 1 year postpartum and that postpartum smoking has negative health consequences for women and children, effective interventions that target postpartum mood and stress are needed. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT00757068.",2016,"Women with more depressive symptoms and higher levels of perceived stress were more likely to relapse (hazard ratio, 1.02; 95% CI, 1.00-1.04; P = .04 for depressive symptoms and hazard ratio, 1.04; 95% CI, 1.01-1.07; P = .003 for stress). ","['Most women who quit smoking during pregnancy will relapse postpartum', 'Participants were recruited between March 2008 and December 2012', 'Pregnant women who recently had quit smoking were recruited before the end of pregnancy', '300 participants (150 randomly assigned to each group']","[""enhanced cognitive behavioral intervention that included additional specialized strategies and content focused on women's postpartum concerns about mood, stress, and weight (Strategies to Avoid Returning to Smoking [STARTS]) or a supportive, time and attention-controlled comparison (SUPPORT"", 'postpartum-adapted, behavioral smoking relapse prevention intervention']","['mood and stress, and the experience of fewer depressive symptoms', 'Postpartum Smoking Relapse', 'self-reported mood, levels of perceived stress, and degree of concern about smoking-related weight gain', 'rates of sustained tobacco abstinence postpartum', 'abstinence or time to relapse', 'sustained tobacco abstinence']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0086839', 'cui_str': 'Postpartum Period'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C2981153', 'cui_str': 'Finding related to focusing'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086839', 'cui_str': 'Postpartum Period'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0332156', 'cui_str': 'Return to (contextual qualifier) (qualifier value)'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0679867', 'cui_str': 'Relapse Prevention'}]","[{'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0205388', 'cui_str': 'Few (qualifier value)'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0086839', 'cui_str': 'Postpartum Period'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0043094', 'cui_str': 'Weight Gain'}, {'cui': 'C0040329', 'cui_str': 'Tobacco Products'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",,0.184509,"Women with more depressive symptoms and higher levels of perceived stress were more likely to relapse (hazard ratio, 1.02; 95% CI, 1.00-1.04; P = .04 for depressive symptoms and hazard ratio, 1.04; 95% CI, 1.01-1.07; P = .003 for stress). ","[{'ForeName': 'Michele D', 'Initials': 'MD', 'LastName': 'Levine', 'Affiliation': 'Western Psychiatric Institute and Clinic, Department of Psychiatry, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Cheng', 'Affiliation': 'Western Psychiatric Institute and Clinic, Department of Psychiatry, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania2Department of Statistics, University of Pittsburgh, Pittsburgh, Pennsylvania3Department of Psychiatry, University of Pitt.'}, {'ForeName': 'Marsha D', 'Initials': 'MD', 'LastName': 'Marcus', 'Affiliation': 'Western Psychiatric Institute and Clinic, Department of Psychiatry, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Melissa A', 'Initials': 'MA', 'LastName': 'Kalarchian', 'Affiliation': 'Department of Psychiatry, University of Pittsburgh, Pittsburgh, Pennsylvania4Duquesne University School of Nursing, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Rebecca L', 'Initials': 'RL', 'LastName': 'Emery', 'Affiliation': 'Western Psychiatric Institute and Clinic, Department of Psychiatry, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania.'}]",JAMA internal medicine,['10.1001/jamainternmed.2016.0248'] 1382,31549310,Cooperative parent-mediated therapy for Italian preschool children with autism spectrum disorder: a randomized controlled trial.,"Parent-mediated intervention is widely used for pre-schoolers with autism spectrum disorder (ASD). Previous studies indicate small-to-moderate effects on social communication skills, but with a wide heterogeneity that requires further research. In this randomized controlled trial (RCT), cooperative parent-mediated therapy (CPMT) an individual parent coaching program for young children with ASD was administered to preschool children with ASD. All children received the same low-intensity psychosocial intervention (LPI) delivered in community settings, to evaluate the potential additional benefit of CPMT. Thirty-four participants with ASD (7 females; 27 males; aged 2, 6, 11 years) and their parents were included in the trial. The primary blinded outcome was social communication skills, assessed using the ADOS-G social communication algorithm score (ADOS-G SC). Secondary outcomes included ASD symptom severity, parent-rated language abilities and emotional/behavioral problems, and self-reported caregiver stress. Evaluations were made at baseline and post-treatment (at 6 months) by an independent multidisciplinary team. Results documented that CPMT showed an additional benefit on LPI with significant improvements of the primary blinded outcome, socio-communication skills, and of some secondary outcomes such as ASD symptom severity, emotional problems and parental stress related to parent-child dysfunctional interaction. No additional benefit was found for language abilities. Findings of our RCT show that CPMT provide an additional significant short-term treatment benefit on ASD core symptoms, when compared with active control group receiving only LPI.",2020,No additional benefit was found for language abilities.,"['young children with ASD was administered to preschool children with ASD', 'Thirty-four participants with ASD (7 females; 27 males; aged 2, 6, 11\xa0years) and their parents were included in the trial', 'Italian preschool children with autism spectrum disorder']","['same low-intensity psychosocial intervention (LPI', 'cooperative parent-mediated therapy (CPMT', 'Cooperative parent-mediated therapy', 'CPMT']","['ASD symptom severity, parent-rated language abilities and emotional/behavioral problems, and self-reported caregiver stress', 'socio-communication skills', 'social communication skills, assessed using the ADOS-G social communication algorithm score (ADOS-G SC', 'ASD symptom severity, emotional problems and parental stress related to parent-child dysfunctional interaction', 'language abilities']","[{'cui': 'C0337547', 'cui_str': 'Younger child (person)'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0008100', 'cui_str': 'Child, Preschool'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0337810', 'cui_str': 'Italians (ethnic group)'}, {'cui': 'C1510586', 'cui_str': 'Autism Spectrum Disorders'}]","[{'cui': 'C0596836', 'cui_str': 'Low intensity'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C1319166', 'cui_str': 'Symptom severity (finding)'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0023008', 'cui_str': 'Languages'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0233514', 'cui_str': 'Behavioral Problem'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0870313', 'cui_str': 'Communication skills'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0002045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0677660', 'cui_str': 'Emotional problems (finding)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}]",34.0,0.339734,No additional benefit was found for language abilities.,"[{'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Valeri', 'Affiliation': ""Department of Neuroscience, IRCCS Children's Hospital Bambino Gesù, Piazza Sant' Onofrio, 4 00165, Rome, Italy.""}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Casula', 'Affiliation': ""Department of Neuroscience, IRCCS Children's Hospital Bambino Gesù, Piazza Sant' Onofrio, 4 00165, Rome, Italy.""}, {'ForeName': 'Deny', 'Initials': 'D', 'LastName': 'Menghini', 'Affiliation': ""Department of Neuroscience, IRCCS Children's Hospital Bambino Gesù, Piazza Sant' Onofrio, 4 00165, Rome, Italy.""}, {'ForeName': 'Filomena Alessandra', 'Initials': 'FA', 'LastName': 'Amendola', 'Affiliation': ""Department of Neuroscience, IRCCS Children's Hospital Bambino Gesù, Piazza Sant' Onofrio, 4 00165, Rome, Italy.""}, {'ForeName': 'Eleonora', 'Initials': 'E', 'LastName': 'Napoli', 'Affiliation': ""Department of Neuroscience, IRCCS Children's Hospital Bambino Gesù, Piazza Sant' Onofrio, 4 00165, Rome, Italy.""}, {'ForeName': 'Patrizio', 'Initials': 'P', 'LastName': 'Pasqualetti', 'Affiliation': 'Service of Medical Statistics and Information Technology, Fatebenefratelli Foundation for Health Research and Education, Rome, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Vicari', 'Affiliation': ""Department of Neuroscience, IRCCS Children's Hospital Bambino Gesù, Piazza Sant' Onofrio, 4 00165, Rome, Italy. giovanni.valeri@opbg.net.""}]",European child & adolescent psychiatry,['10.1007/s00787-019-01395-5'] 1383,32417348,Concurrent cisplatin and dose escalation with intensity-modulated radiotherapy (IMRT) versus conventional radiotherapy for locally advanced head and neck squamous cell carcinomas (HNSCC): GORTEC 2004-01 randomized phase III trial.,"BACKGROUND Concurrent chemoradiotherapy (CRT) is the standard of care (SoC) in locally advanced (LA) head and neck squamous cell carcinomas (HNSCC). This trial was designed to test whether dose-escalated IMRT and cisplatin could improve locoregional control without increasing complications over 3D-radiotherapy. METHODS Patients were randomized between 70 Gy/35F in 7 weeks with 3D-RT (Arm A) versus 75 Gy/35F with IMRT (Arm B). Both arms received 50 Gy in 25 fractions followed by a sequential boost of 20 Gy/10F in Arm A and 25 Gy/10F to gross tumor volume in Arm B, as well as 3 cycles of cisplatin at 100 mg/m2 during RT. The primary endpoint was locoregional progression (LRP). RESULTS 188 patients were randomized: 85% oropharynx and 73% stage IVa. P16 status was documented for 137 oropharyngeal tumors with P16+ in 53 (39%) patients; and 90% were smokers. Median follow-up was 60.5 months. Xerostomia was markedly decreased in arm B (p < 0.0001). The 1-year grade ≥2 xerostomia (RTOG criteria) was 63% vs 23% and 3-year 45% vs 11% in arms A and B, respectively. Xerostomia LENT-SOMA scale was also reduced in arm B. Dose-escalated IMRT did not reduce LRP with an adjusted HR of 1.13 [95%CI = 0.64-1.98] (p = 0.68). Survival was not different (adjusted HR: 1.19 [95%CI = 0.78-1.81], p = 0.42). No interaction between p16 and treatment effect was found. CONCLUSION Dose-escalated IMRT did not improve LRC in LA-HNSCC patients treated with concomitant CRT over standard 3D-RT. This trial reinforces the evidence showing IMRT reduces xerostomia in LA-HNSCC treated with radiotherapy. Clinicaltrial.gov: NCT00158678.",2020,"CONCLUSION Dose-escalated IMRT did not improve LRC in LA-HNSCC patients treated with concomitant CRT over standard 3D-RT.","['locally advanced (LA) head and neck squamous cell carcinomas (HNSCC', '188 patients were randomized: 85% oropharynx and 73% stage IVa', 'patients', 'locally advanced head and neck squamous cell carcinomas (HNSCC']","['Concurrent chemoradiotherapy (CRT', 'radiotherapy', 'Concurrent cisplatin and Dose escalation with Intensity-modulated radiotherapy (IMRT', 'cisplatin', 'conventional radiotherapy', 'IMRT and cisplatin', '75Gy/35F with IMRT']","['1-year grade ≥ 2 xerostomia (RTOG criteria', 'Xerostomia LENT-SOMA scale', 'Survival', 'P16 status', 'Xerostomia', 'locoregional progression (LRP', 'xerostomia']","[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C1168401', 'cui_str': 'Squamous cell carcinoma of head and neck'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0521367', 'cui_str': 'Oropharyngeal structure'}, {'cui': 'C0441773', 'cui_str': 'Stage IVa'}]","[{'cui': 'C3178775', 'cui_str': 'Concomitant Radiochemotherapy'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C1512814', 'cui_str': 'Intensity modulated radiation therapy'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0043352', 'cui_str': 'Xerostomia'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0702216', 'cui_str': 'Soma'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0249880', 'cui_str': 'Cdk4-Associated Protein p16'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}]",188.0,0.356655,"CONCLUSION Dose-escalated IMRT did not improve LRC in LA-HNSCC patients treated with concomitant CRT over standard 3D-RT.","[{'ForeName': 'Yungan', 'Initials': 'Y', 'LastName': 'Tao', 'Affiliation': 'Gustave-Roussy Cancer Campus Grand Paris, Villejuif, France. Electronic address: yungan.tao@gustaveroussy.fr.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Auperin', 'Affiliation': 'Gustave-Roussy Cancer Campus Grand Paris, Villejuif, France; INSERM 1018, Villefjuif, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Blanchard', 'Affiliation': 'Gustave-Roussy Cancer Campus Grand Paris, Villejuif, France.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Alfonsi', 'Affiliation': 'Institut Sainte Catherine, Avignon, France.'}, {'ForeName': 'Xu-Shan', 'Initials': 'XS', 'LastName': 'Sun', 'Affiliation': 'Hopital Nord Franche-Comté de Montbéliard & CHRU de Besançon, France.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Rives', 'Affiliation': 'Institut Claudius Regaud, Toulouse, France.'}, {'ForeName': 'Yoann', 'Initials': 'Y', 'LastName': 'Pointreau', 'Affiliation': 'Centre Jean Bernard, Le Mans, France.'}, {'ForeName': 'Joël', 'Initials': 'J', 'LastName': 'Castelli', 'Affiliation': 'Centre Eugène Marquis, Rennes, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Graff', 'Affiliation': 'Institut Claudius Regaud, Toulouse, France; Centre Alexis Vautrin, Nancy, France.'}, {'ForeName': 'Stéphanie', 'Initials': 'S', 'LastName': 'Wong Hee Kam', 'Affiliation': 'AP-HM Hôpital de la Timone, Marseille, France.'}, {'ForeName': 'Juliette', 'Initials': 'J', 'LastName': 'Thariat', 'Affiliation': 'Centre Antoine Lacassagne, Nice, France; Centre francois Baclesse, Caen, France.'}, {'ForeName': 'Ovidiu', 'Initials': 'O', 'LastName': 'Veresezan', 'Affiliation': 'Centre Henri Becquerel, Rouen, France.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Heymann', 'Affiliation': 'Clinique Sainte Anne, Strasbourg, France.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Renard-Oldrini', 'Affiliation': 'Centre Alexis Vautrin, Nancy, France.'}, {'ForeName': 'Cédrik', 'Initials': 'C', 'LastName': 'Lafond', 'Affiliation': 'Centre Jean Bernard, Le Mans, France.'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Cornely', 'Affiliation': 'Gustave-Roussy Cancer Campus Grand Paris, Villejuif, France.'}, {'ForeName': 'Odile', 'Initials': 'O', 'LastName': 'Casiraghi', 'Affiliation': 'Gustave-Roussy Cancer Campus Grand Paris, Villejuif, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Boisselier', 'Affiliation': 'Centre Eugène Marquis, Rennes, France; Institut du Cancer de Montpellier, France.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Lapeyre', 'Affiliation': 'Centre Alexis Vautrin, Nancy, France; Centre Jean Perrin, Clermont-Ferrand, France.'}, {'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Biau', 'Affiliation': 'Centre Jean Perrin, Clermont-Ferrand, France.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Bourhis', 'Affiliation': 'Gustave-Roussy Cancer Campus Grand Paris, Villejuif, France; CHUV Lausanne, Switzerland. Electronic address: jean.bourhis@chuv.ch.'}]",Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology,['10.1016/j.radonc.2020.05.021'] 1384,32421226,Bevacizumab plus chemotherapy in nonsquamous non-small cell lung cancer patients with malignant pleural effusion uncontrolled by tube drainage or pleurodesis: A phase II study North East Japan Study group trial NEJ013B.,"BACKGROUND Pleurodesis is the standard of care for non-small cell lung cancer (NSCLC) patients with symptomatic malignant pleural effusion (MPE). However, there is no standard management for MPE uncontrolled by pleurodesis. Most patients with unsuccessful MPE control are unable to receive effective chemotherapy. Vascular endothelial growth factor (VEGF) plays an important role in the pathogenesis of MPE. This multicenter, phase II study investigated the effects of bevacizumab plus chemotherapy in nonsquamous NSCLC patients with unsuccessful management of MPE. METHODS Nonsquamous NSCLC patients with MPE following unsuccessful tube drainage or pleurodesis received bevacizumab (15 mg/kg) plus chemotherapy every three weeks. The primary endpoint was pleural effusion control rate (PECR), defined as the percentage of patients without reaccumulation of MPE at eight weeks. Secondary endpoints included pleural progression-free survival (PPFS), safety, and quality of life (QoL). RESULTS A total of 20 patients (median age: 69 years; 14 males; 20 adenocarcinomas; six epidermal growth factor receptor mutations) were enrolled in nine centers. The PECR was 80% and the primary end point was met. The PPFS and the overall survival (OS) were 16.6 months and 19.6 months, respectively. Patients with high levels of VEGF in the MPE had shorter PPFS (P = 0.010) and OS (P = 0.002). Toxicities of grade ≥ 3 included neutropenia (50%), thrombocytopenia (10%), proteinuria (10%), and hypertension (2%). The cognitive QoL score improved after treatment. CONCLUSIONS Bevacizumab plus chemotherapy is highly effective with acceptable toxicities in nonsquamous NSCLC patients with uncontrolled MPE, and should be considered as a standard therapy in this setting. KEY POINTS SIGNIFICANT FINDINGS OF THE STUDY: Bevacizumab plus chemotherapy is highly effective with acceptable toxicities in nonsquamous NSCLC patients with uncontrolled MPE. WHAT THIS STUDY ADDS Bevacizumab plus chemotherapy should be considered as a standard treatment option for patients with uncontrolled MPE. CLINICAL TRIAL REGISTRATION UMIN000006868 was a phase II study of efficacy of bevacizumab plus chemotherapy for the management of malignant pleural effusion (MPE) in nonsquamous non-small cell lung cancer patients with MPE unsuccessfully controlled by tube drainage or pleurodesis (North East Japan Study Group Trial NEJ-013B) (http://umin.sc.jp/ctr/).",2020,Patients with high levels of VEGF in the MPE had shorter PPFS (P = 0.010) and OS (P = 0.002).,"['nonsquamous NSCLC patients with unsuccessful management of MPE', 'Nonsquamous NSCLC patients with MPE following unsuccessful tube drainage or pleurodesis received', 'nonsquamous non-small cell lung cancer patients with MPE unsuccessfully controlled by', '20 patients (median age: 69\u2009years; 14 males; 20 adenocarcinomas; six epidermal growth factor receptor mutations) were enrolled in nine centers', 'nonsquamous non-small cell lung cancer patients with malignant pleural effusion uncontrolled by tube drainage or pleurodesis', 'non-small cell lung cancer (NSCLC) patients with symptomatic malignant pleural effusion (MPE', 'nonsquamous NSCLC patients with uncontrolled MPE', 'patients with uncontrolled MPE']","['tube drainage or pleurodesis', 'Bevacizumab plus chemotherapy', 'bevacizumab', 'bevacizumab plus chemotherapy']","['cognitive QoL score', 'thrombocytopenia', 'shorter PPFS', 'pleural progression-free survival (PPFS), safety, and quality of life (QoL', 'Toxicities of grade\u2009≥\u20093 included neutropenia', 'pleural effusion control rate (PECR), defined as the percentage of patients without reaccumulation of MPE', 'overall survival (OS']","[{'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1272705', 'cui_str': 'Unsuccessful'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0080032', 'cui_str': 'Neoplastic pleural effusion'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0184114', 'cui_str': 'Tube drain'}, {'cui': 'C0189557', 'cui_str': 'Pleurodesis'}, {'cui': 'C0332298', 'cui_str': 'Controlled by'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001418', 'cui_str': 'Adenocarcinoma'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0205318', 'cui_str': 'Uncontrolled'}]","[{'cui': 'C0184114', 'cui_str': 'Tube drain'}, {'cui': 'C0189557', 'cui_str': 'Pleurodesis'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0040034', 'cui_str': 'Thrombocytopenic disorder'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C1522720', 'cui_str': 'Pleural'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0032227', 'cui_str': 'Pleural effusion'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0080032', 'cui_str': 'Neoplastic pleural effusion'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",20.0,0.123536,Patients with high levels of VEGF in the MPE had shorter PPFS (P = 0.010) and OS (P = 0.002).,"[{'ForeName': 'Rintaro', 'Initials': 'R', 'LastName': 'Noro', 'Affiliation': 'Department of Pulmonary Medicine and Oncology, Graduate School of Medicine, Nippon Medical School, Tokyo, Japan.'}, {'ForeName': 'Kunihiko', 'Initials': 'K', 'LastName': 'Kobayashi', 'Affiliation': 'Department of Respiratory medicine, Saitama Medical University International Medical Center, Saitama, Japan.'}, {'ForeName': 'Jiro', 'Initials': 'J', 'LastName': 'Usuki', 'Affiliation': 'Department of Pulmonary Medicine, Nippon Medical School Musashikosugi Hospital, Kawasaki, Japan.'}, {'ForeName': 'Makiko', 'Initials': 'M', 'LastName': 'Yomota', 'Affiliation': 'Department of Thoracic Oncology and Respiratory Medicine, Tokyo Metropolitan Cancer and Infectious disease Center Komagome Hospital, Tokyo, Japan.'}, {'ForeName': 'Masaru', 'Initials': 'M', 'LastName': 'Nishitsuji', 'Affiliation': 'Department of Respiratory Medicine, Ishikawa Prefectural Central Hospital, Kanazawa, Japan.'}, {'ForeName': 'Tsuneo', 'Initials': 'T', 'LastName': 'Shimokawa', 'Affiliation': ""Department of Respiratory Medicine and Medical Oncology, Yokohama Municipal Citizen's Hospital, Yokohama, Japan.""}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Ando', 'Affiliation': 'Department of Internal Medicine, Jizankai Medical Foundation Tsuboi Cancer Center Hospital, Fukushima, Japan.'}, {'ForeName': 'Mitsunori', 'Initials': 'M', 'LastName': 'Hino', 'Affiliation': 'Department of Pulmonary Medicine, Nippon Medical School Chiba Hokuso Hospital, Chiba, Japan.'}, {'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Hagiwara', 'Affiliation': 'Division of Pulmonary Medicine, Jichi Medical University, Tochigi, Japan.'}, {'ForeName': 'Akihiko', 'Initials': 'A', 'LastName': 'Miyanaga', 'Affiliation': 'Department of Pulmonary Medicine and Oncology, Graduate School of Medicine, Nippon Medical School, Tokyo, Japan.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Seike', 'Affiliation': 'Department of Pulmonary Medicine and Oncology, Graduate School of Medicine, Nippon Medical School, Tokyo, Japan.'}, {'ForeName': 'Kaoru', 'Initials': 'K', 'LastName': 'Kubota', 'Affiliation': 'Department of Pulmonary Medicine and Oncology, Graduate School of Medicine, Nippon Medical School, Tokyo, Japan.'}, {'ForeName': 'Akihiko', 'Initials': 'A', 'LastName': 'Gemma', 'Affiliation': 'Department of Pulmonary Medicine and Oncology, Graduate School of Medicine, Nippon Medical School, Tokyo, Japan.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Thoracic cancer,['10.1111/1759-7714.13472'] 1385,30862225,Feasibility of a Mindfulness-Based Intervention for Caregivers of Veterans: A Pilot Study.,"Purpose: This pilot study aimed to assess the feasibility of conducting an 8-week mindfulness-based intervention with caregivers of veterans and to examine the effectiveness of the intervention to improve mindfulness using the Five Facet Mindfulness Questionnaire compared with waitlist controls. Design: In this randomized controlled trial, 23 caregivers of veterans were assigned to either the intervention or waitlist group. Method: Compliance with mindfulness instruction and attendance was assessed among those in the intervention. Wilcoxon signed-rank tests compared within group pre- and post-intervention scores and Mann-Whitney U tests compared difference scores (post-pre) by group type. Effect sizes were also calculated. Compliance variables were correlated with difference scores in the intervention group only . Findings: Of the 23 participants, 11 were assigned to the intervention; 100% of participants were retained. There was significant improvement from pre- to post-intervention in four of the five facets of mindfulness ( p < .05) in the intervention group. Significant between-group differences ( p < .05) were also observed in two of the five facets. Effect sizes ranged from small (.44) to large (.89). No significant improvement was observed in the waitlist control group. Conclusions: A mindfulness-based intervention is feasible and acceptable to improve mindfulness in caregivers of veterans.",2019,There was significant improvement from pre- to post-intervention in four of the five facets of mindfulness ( p < .05) in the intervention group.,"['Caregivers of Veterans', '23 participants', 'caregivers of veterans', '23 caregivers of veterans']","['intervention or waitlist group', 'Mindfulness-Based Intervention']",['Wilcoxon signed-rank tests'],"[{'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0178499', 'cui_str': 'Base'}]","[{'cui': 'C0311392', 'cui_str': 'Sign'}, {'cui': 'C0699794', 'cui_str': 'Rank (attribute)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}]",23.0,0.0182814,There was significant improvement from pre- to post-intervention in four of the five facets of mindfulness ( p < .05) in the intervention group.,"[{'ForeName': 'Sandraluz', 'Initials': 'S', 'LastName': 'Lara-Cinisomo', 'Affiliation': 'University of Illinois at Urbana-Champaign.'}, {'ForeName': 'Elinor M', 'Initials': 'EM', 'LastName': 'Fujimoto', 'Affiliation': 'University of Illinois at Urbana-Champaign.'}, {'ForeName': 'Ryan L', 'Initials': 'RL', 'LastName': 'Santens', 'Affiliation': 'University of Illinois at Urbana-Champaign.'}]",Journal of holistic nursing : official journal of the American Holistic Nurses' Association,['10.1177/0898010119831580'] 1386,31914834,"Effect of whole soy and purified daidzein on androgenic hormones in chinese equol-producing post-menopausal women: a six-month randomised, double-blinded and Placebo-Controlled trial.","A randomised, double-blind and placebo-controlled trial was performed to examine the effects of whole soy and isoflavone daidzein on serum androgenic hormones in Chinese equol-producing post-menopausal women. A total of 270 eligible women aged 45-70 years were randomised to either one of the three iso-caloric supplements: 40 g soy flour (whole soy group), 40 g low-fat milk powder +63 mg daidzein (daidzein group) or 40 g low-fat milk powder (placebo group) daily for 6 months. Fasting venous samples were tested for serum androstenedione (AD), testosterone (T), prolactin, sex hormone binding globulin and dehydroepiandrosterone sulphate. Intention-to-treat analysis indicated that serum T ( p  = .022) and AD ( p  = .05) levels modestly but significantly decreased after 6-month daidzein treatment in comparison with placebo, with a mean difference of -0.057 nmol/L (95%CI: -0.185 to 0.070, p  = .018) and -0.118 ng/mL (95%CI: -0.240-0.004, p  = .045), respectively. This 6-month trial suggested that purified daidzein may exhibit less androgenic effect. Trial registration: The trial was registered in ClinicalTrials.gov with identifier of NCT01270737. (URL: http://clinicaltrials.gov/ct2/show/NCT01270737.).",2020,"Intention-to-treat analysis indicated that serum T ( p  = .022) and AD ( p  = .05) levels modestly but significantly decreased after 6-month daidzein treatment in comparison with placebo, with a mean difference of -0.057 nmol/L (95%CI: -0.185 to 0.070, p  = .018) and -0.118 ng/mL","['270 eligible women aged 45-70\u2009years', 'Chinese equol-producing post-menopausal women', 'chinese equol-producing post-menopausal women']","['Placebo', 'daidzein', 'soy flour (whole soy group), 40\u2009g low-fat milk powder +63\u2009mg daidzein (daidzein group) or 40\u2009g low-fat milk powder (placebo', 'placebo', 'whole soy and isoflavone daidzein', '95%CI', 'whole soy and purified daidzein', 'purified daidzein']","['serum androstenedione (AD), testosterone (T), prolactin, sex hormone binding globulin and dehydroepiandrosterone sulphate', 'androgenic effect', 'androgenic hormones', 'serum androgenic hormones']","[{'cui': 'C4319603', 'cui_str': '270 (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C3892880', 'cui_str': '(R) - EQUOL'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0025320', 'cui_str': 'Change of Life, Female'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0057090', 'cui_str': 'diadzein'}, {'cui': 'C0771806', 'cui_str': 'Soya flour (substance)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0452714', 'cui_str': 'Semi-skimmed milk (substance)'}, {'cui': 'C0032861', 'cui_str': 'Powdered drug preparation'}, {'cui': 'C0022179', 'cui_str': 'Isoflavone Derivatives'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0002860', 'cui_str': 'androstanedione'}, {'cui': 'C0523912', 'cui_str': 'Testosterone measurement (procedure)'}, {'cui': 'C0033371', 'cui_str': 'Prolactin'}, {'cui': 'C0202218', 'cui_str': 'Sex hormone binding globulin measurement (procedure)'}, {'cui': 'C0057277', 'cui_str': 'Prasterone Sulfate'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}]",270.0,0.813136,"Intention-to-treat analysis indicated that serum T ( p  = .022) and AD ( p  = .05) levels modestly but significantly decreased after 6-month daidzein treatment in comparison with placebo, with a mean difference of -0.057 nmol/L (95%CI: -0.185 to 0.070, p  = .018) and -0.118 ng/mL","[{'ForeName': 'Zhao-Min', 'Initials': 'ZM', 'LastName': 'Liu', 'Affiliation': 'Guangdong Provincial Key Laboratory of Food, Nutrition and Health; Department of Nutrition, School of Public Health, Sun Yat-sen University, Guangzhou, PR China.'}, {'ForeName': 'Guoyi', 'Initials': 'G', 'LastName': 'Li', 'Affiliation': 'Guangdong Provincial Key Laboratory of Food, Nutrition and Health; Department of Nutrition, School of Public Health, Sun Yat-sen University, Guangzhou, PR China.'}, {'ForeName': 'Di', 'Initials': 'D', 'LastName': 'Zhang', 'Affiliation': 'Guangdong Provincial Key Laboratory of Food, Nutrition and Health; Department of Nutrition, School of Public Health, Sun Yat-sen University, Guangzhou, PR China.'}, {'ForeName': 'Suzanne C', 'Initials': 'SC', 'LastName': 'Ho', 'Affiliation': 'Department of Epidemiology, Jockey Club School of Public Health and Primary Care, the Chinese University of Hong Kong, New Territories, Hong Kong.'}, {'ForeName': 'Yu-Ming', 'Initials': 'YM', 'LastName': 'Chen', 'Affiliation': 'Department of Biostatistics and Epidemiology, Sun Yat-sen University, Guangzhou, PR China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Ma', 'Affiliation': 'Guangdong Provincial Key Laboratory of Food, Nutrition and Health; Department of Nutrition, School of Public Health, Sun Yat-sen University, Guangzhou, PR China.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Huang', 'Affiliation': 'Guangdong Provincial Key Laboratory of Food, Nutrition and Health; Department of Nutrition, School of Public Health, Sun Yat-sen University, Guangzhou, PR China.'}, {'ForeName': 'Shuyi', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'Guangdong Provincial Key Laboratory of Food, Nutrition and Health; Department of Nutrition, School of Public Health, Sun Yat-sen University, Guangzhou, PR China.'}, {'ForeName': 'Wen-Hua', 'Initials': 'WH', 'LastName': 'Ling', 'Affiliation': 'Guangdong Provincial Key Laboratory of Food, Nutrition and Health; Department of Nutrition, School of Public Health, Sun Yat-sen University, Guangzhou, PR China.'}]",International journal of food sciences and nutrition,['10.1080/09637486.2020.1712682'] 1387,26291010,Prognostic Impact of Immune Microenvironment in Lung Squamous Cell Carcinoma: Tumor-Infiltrating CD10+ Neutrophil/CD20+ Lymphocyte Ratio as an Independent Prognostic Factor.,"INTRODUCTION We previously reported the prognostic significance of the lung adenocarcinoma immune microenvironment. In this study, we preformed comprehensive analysis of immune markers and their associations with prognosis in patients with lung squamous cell carcinoma. METHODS We reviewed surgically resected, solitary lung squamous cell carcinoma patients (n = 485; 1999-2009) who were randomly split into a training cohort (n = 331) and validation cohort (n = 154). We constructed tissue microarrays and performed immunostaining for CD3, CD45RO, CD8, CD4, FoxP3, CD20, CD68, CXCL12, CXCR4, CCR7, interleukin-7 receptor, and interleukin-12 receptor β2. Overall survival (OS) was analyzed using the log-rank test and the Cox proportional hazards model. RESULTS Analysis of single immune cell infiltration revealed that high tumor-infiltrating CD10(+) neutrophils were associated with worse prognoses in the training cohort (p = 0.021). Analysis of biologically relevant immune cell combinations identified that patients with high CD10 neutrophil and low CD20(+) lymphocyte had a significantly worse OS (5-year OS, 42%) than those with other combinations of CD10 and CD20 (5-year OS, 62%; p < 0.001); this was confirmed in the validation cohort (p = 0.032). For the multivariate analysis, high CD10/low CD20 immune cell infiltration was an independent predictor of OS in both the training cohort (hazard ratio = 1.61, p = 0.006) and the validation cohort (hazard ratio = 1.75; p = 0.043). CONCLUSION High CD10(+)/low CD20(+) immune cell infiltration ratio is a significant prognostic factor of lung squamous cell carcinoma. Immunomodulatory therapy of tumor-specific neutrophil and B-lymphocyte responses may have applicability in the treatment of lung squamous cell carcinoma.",2015,"We constructed tissue microarrays and performed immunostaining for CD3, CD45RO, CD8, CD4, FoxP3, CD20, CD68, CXCL12, CXCR4, CCR7, interleukin-7 receptor, and interleukin-12 receptor β2.","['lung squamous cell carcinoma', 'We reviewed surgically resected, solitary lung squamous cell carcinoma patients (n = 485; 1999-2009) who were randomly split into a training cohort (n = 331) and validation cohort (n = 154', 'patients with lung squamous cell carcinoma', 'Lung Squamous Cell Carcinoma']",[],"['high tumor-infiltrating CD10(+) neutrophils', 'CD3, CD45RO, CD8, CD4, FoxP3, CD20, CD68, CXCL12, CXCR4, CCR7, interleukin-7 receptor, and interleukin-12 receptor β2', 'Overall survival (OS']","[{'cui': 'C0024109', 'cui_str': 'Lung'}, {'cui': 'C0007137', 'cui_str': 'Carcinoma, Planocellular'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0043237', 'cui_str': 'WHO'}, {'cui': 'C0332286', 'cui_str': 'Into (attribute)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}]",[],"[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0332448', 'cui_str': 'Tissue infiltration'}, {'cui': 'C0083032', 'cui_str': 'Receptors, IL-7'}, {'cui': 'C0255732', 'cui_str': 'IL-12 Receptors'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",,0.0666744,"We constructed tissue microarrays and performed immunostaining for CD3, CD45RO, CD8, CD4, FoxP3, CD20, CD68, CXCL12, CXCR4, CCR7, interleukin-7 receptor, and interleukin-12 receptor β2.","[{'ForeName': 'Kyuichi', 'Initials': 'K', 'LastName': 'Kadota', 'Affiliation': 'Thoracic Service, Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, New York; Department of Pathology, Memorial Sloan Kettering Cancer Center, New York, New York; Faculty of Medicine, Department of Diagnostic Pathology, Kagawa University, Kagawa, Japan.'}, {'ForeName': 'Jun-Ichi', 'Initials': 'JI', 'LastName': 'Nitadori', 'Affiliation': 'Thoracic Service, Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, New York; Department of Thoracic Surgery, University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Hideki', 'Initials': 'H', 'LastName': 'Ujiie', 'Affiliation': 'Thoracic Service, Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Daniel H', 'Initials': 'DH', 'LastName': 'Buitrago', 'Affiliation': 'Thoracic Service, Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Kaitlin M', 'Initials': 'KM', 'LastName': 'Woo', 'Affiliation': 'Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Camelia S', 'Initials': 'CS', 'LastName': 'Sima', 'Affiliation': 'Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'William D', 'Initials': 'WD', 'LastName': 'Travis', 'Affiliation': 'Department of Pathology, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Jones', 'Affiliation': 'Thoracic Service, Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Prasad S', 'Initials': 'PS', 'LastName': 'Adusumilli', 'Affiliation': 'Thoracic Service, Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, New York; Center for Cell Engineering, Memorial Sloan Kettering Cancer Center, New York, New York. Electronic address: adusumip@mskcc.org.'}]",Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer,['10.1097/JTO.0000000000000617'] 1388,32100679,"Improving Complementary Food Hygiene Behaviors Using the Risk, Attitude, Norms, Ability, and Self-Regulation Approach in Rural Malawi.","The study evaluated the effectiveness of an intervention to improve complementary food hygiene behaviors among child caregivers in rural Malawi. Formative research and intervention development was grounded in the risk, attitude, norms, ability, and self-regulation (RANAS) model and targeted washing hands and kitchen utensils with soap, safe utensil storage, reheating of leftover food, and feeding of children by caregivers. Longitudinal research was applied at baseline and follow-up surveys among 320 caregivers. Determinants of selected behaviors were found, and interventions were developed based on the behavior change techniques aligned with these determinants in the RANAS model. The intervention was delivered over 9 months through group (cluster) meetings and household visits and included demonstrations, games, rewards, and songs. We randomly assigned villages to the control or intervention group. Follow-up results indicated a significant increase in three targeted behaviors (washing kitchen utensils with soap, safe utensil storage, and handwashing with soap) among intervention recipients. Several psychosocial factors differed significantly between the intervention and control groups. Mediation results showed that the intervention had a significant effect on these three targeted behaviors. For handwashing, feelings, others' behavior in the household, and remembering; for washing kitchen utensils, others' behavior in the household and difficulty to get enough soap; for safe utensils storage, others' behavior in the village and remembering mediated the effect of the intervention on the targeted behaviors. The study demonstrated that targeting food hygiene behaviors with a theory-driven behavior change approach using psychosocial factors can improve the behavior of child caregivers in rural Malawi.",2020,Several psychosocial factors differed significantly between the intervention and control groups.,"['Rural Malawi', 'child caregivers in rural Malawi', '320 caregivers']",[],['Several psychosocial factors'],"[{'cui': 'C0024548', 'cui_str': 'Republic of Malawi'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C4517711', 'cui_str': '320 (qualifier value)'}]",[],"[{'cui': 'C0033963', 'cui_str': 'Psychosocial Factors'}]",,0.0199568,Several psychosocial factors differed significantly between the intervention and control groups.,"[{'ForeName': 'Kondwani', 'Initials': 'K', 'LastName': 'Chidziwisano', 'Affiliation': 'Department of Civil and Environmental Engineering, University of Strathclyde, Glasgow, United Kingdom.'}, {'ForeName': 'Jurgita', 'Initials': 'J', 'LastName': 'Slekiene', 'Affiliation': 'Eawag, Swiss Federal Institute of Aquatic Science and Technology, Dübendorf, Switzerland.'}, {'ForeName': 'Hans-Joachim', 'Initials': 'HJ', 'LastName': 'Mosler', 'Affiliation': 'Eawag, Swiss Federal Institute of Aquatic Science and Technology, Dübendorf, Switzerland.'}, {'ForeName': 'Tracy', 'Initials': 'T', 'LastName': 'Morse', 'Affiliation': 'Department of Civil and Environmental Engineering, University of Strathclyde, Glasgow, United Kingdom.'}]",The American journal of tropical medicine and hygiene,['10.4269/ajtmh.19-0528'] 1389,31063867,Phase II trial of web-based tailored asthma management intervention in adolescents at clinics.,,2019,,['adolescents at clinics'],['web-based tailored asthma management intervention'],[],"[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}]","[{'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1318955', 'cui_str': 'Asthma management'}]",[],,0.0111522,,"[{'ForeName': 'Mei', 'Initials': 'M', 'LastName': 'Lu', 'Affiliation': 'Department of Public Health Sciences, Henry Ford Hospital, Detroit, MI, USA. Electronic address: mlu1@hfhs.org.'}, {'ForeName': 'Talan', 'Initials': 'T', 'LastName': 'Zhang', 'Affiliation': 'Department of Public Health Sciences, Henry Ford Hospital, Detroit, MI, USA.'}, {'ForeName': 'Dennis R', 'Initials': 'DR', 'LastName': 'Ownby', 'Affiliation': 'Department of Pediatrics, Augusta University, Augusta, GA, USA.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Zoratti', 'Affiliation': 'Department of Internal Medicine, Division of Allergy, Henry Ford Hospital, Detroit, MI, USA.'}, {'ForeName': 'Dayna A', 'Initials': 'DA', 'LastName': 'Johnson', 'Affiliation': 'Department of Epidemiology, Rollins School of Public Health Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Renee', 'Initials': 'R', 'LastName': 'William', 'Affiliation': 'Department of Public Health Sciences, Henry Ford Hospital, Detroit, MI, USA.'}, {'ForeName': 'Cheryl', 'Initials': 'C', 'LastName': 'Miree', 'Affiliation': 'Department of Public Health Sciences, Henry Ford Hospital, Detroit, MI, USA.'}, {'ForeName': 'Christine L M', 'Initials': 'CLM', 'LastName': 'Joseph', 'Affiliation': 'Department of Public Health Sciences, Henry Ford Hospital, Detroit, MI, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2019.04.011'] 1390,25344361,High-dose sequential chemotherapy (HDS) versus PEB chemotherapy as first-line treatment of patients with poor prognosis germ-cell tumors: mature results of an Italian randomized phase II study.,"BACKGROUND In the late 1990s, the use of high-dose chemotherapy (HDCT) and stem-cell rescue held promise for patients with advanced and poor prognosis germ-cell tumors (GCT). We started a randomized phase II trial to assess the efficacy of sequential HDCT compared with cisplatin, etoposide, and bleomycin (PEB). PATIENTS AND METHODS Patients were randomly assigned to receive four cycles of PEB every 3 weeks or two cycles of PEB followed by a high-dose sequence (HDS) comprising HD-cyclophosphamide (7.0 g/m(2)), 2 courses of cisplatin and HD-etoposide (2.4 g/m(2)) with stem-cell support, and a single course of HD-carboplatin [area under the curve (AUC) 27 mg/ml × min] with autologous stem-cell transplant. Postchemotherapy surgery was planned on responding residual disease in both arms. The primary end point was progression-free survival (PFS). The study was designed to detect a 30% improvement of 5-year PFS (from 40% to 70%), with 80% power and two-sided α at 5%. RESULTS From December 1996 to March 2007, 85 patients were randomized: 43 in PEB and 42 in HDS arm. Median follow-up was 114.2 months [interquartile range (IQR): 87.7-165.8]. Complete or partial response with normal markers (PRm-) were obtained in 28 (65.1%) and 29 (69.1%) patients, respectively. Five-year PFS was 55.8% [95% confidence interval (CI) 42.8-72.8] and 54.8% (95% CI 41.6%-72.1%) in PEB and HDS arm, respectively (log-rank test P = 0.726). Five-year overall survival was 62.8% (95% CI 49.9-79.0) and 59.3% (95% CI 46.1-76.3). One toxic death (PEB arm) was recorded. CONCLUSIONS The study failed to meet the primary end point. Furthermore, survival estimates of conventional-dose chemotherapy higher than expected should be accounted for and will likely limit further improvements in the first-line setting. CLINICALTRIALS.GOV: NCT02161692.",2015,Five-year overall survival was 62.8% (95% CI 49.9-79.0) and 59.3% (95% CI 46.1-76.3).,"['patients with advanced and poor prognosis germ-cell tumors (GCT', 'Patients', 'patients with poor prognosis germ-cell tumors', 'From December 1996 to March 2007, 85 patients were randomized: 43 in PEB and 42 in HDS arm']","['high-dose chemotherapy (HDCT', 'High-dose sequential chemotherapy (HDS) versus PEB chemotherapy', 'sequential HDCT', 'cisplatin, etoposide, and bleomycin (PEB', 'PEB', 'cisplatin and HD-etoposide (2.4 g/m(2)) with stem-cell support, and a single course of HD-carboplatin [area under the curve (AUC) 27 mg/ml × min] with autologous stem-cell transplant', 'Postchemotherapy surgery', 'PEB followed by a high-dose sequence (HDS) comprising HD-cyclophosphamide']","['survival estimates', 'overall survival', 'Complete or partial response with normal markers (PRm', '5-year PFS', 'progression-free survival (PFS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0278252', 'cui_str': 'Prognosis bad (finding)'}, {'cui': 'C0205851', 'cui_str': 'Neoplasms, Germ Cell'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}]","[{'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0015133', 'cui_str': 'Etoposide'}, {'cui': 'C0005740', 'cui_str': 'Bleomycin'}, {'cui': 'C4517631', 'cui_str': '2.4 (qualifier value)'}, {'cui': 'C0038250', 'cui_str': 'Mother Cells'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0750729', 'cui_str': 'Courses (qualifier value)'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0439294', 'cui_str': 'mcg/mcL'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C1504389', 'cui_str': 'Stem Cell Transplantation'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}]","[{'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",85.0,0.199672,Five-year overall survival was 62.8% (95% CI 49.9-79.0) and 59.3% (95% CI 46.1-76.3).,"[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Necchi', 'Affiliation': 'Department of Medical Oncology. Electronic address: andrea.necchi@istitutotumori.mi.it.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Mariani', 'Affiliation': 'Clinical Epidemiology and Trials Organization Unit.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Di Nicola', 'Affiliation': 'Department of Medical Oncology.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Lo Vullo', 'Affiliation': 'Clinical Epidemiology and Trials Organization Unit.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Nicolai', 'Affiliation': 'Department of Surgery, Urology Unit, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Giannatempo', 'Affiliation': 'Department of Medical Oncology.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Raggi', 'Affiliation': 'Department of Medical Oncology.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Farè', 'Affiliation': 'Department of Medical Oncology.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Magni', 'Affiliation': 'Department of Medical Oncology.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Piva', 'Affiliation': 'Department of Surgery, Urology Unit, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Matteucci', 'Affiliation': 'Department of Medical Oncology.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Catanzaro', 'Affiliation': 'Department of Surgery, Urology Unit, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Biasoni', 'Affiliation': 'Department of Surgery, Urology Unit, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Torelli', 'Affiliation': 'Department of Surgery, Urology Unit, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Stagni', 'Affiliation': 'Department of Surgery, Urology Unit, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Bengala', 'Affiliation': 'Department of Medical Oncology, Ospedale Misericordia, Grosseto.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Barone', 'Affiliation': 'Department of Medical Oncology, Oncologia Medica ASL TO5 Ospedale di Carmagnola, Turin.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Schiavetto', 'Affiliation': ""Niguarda Cancer Center, Ospedale Niguarda Ca' Granda, Milan.""}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Siena', 'Affiliation': ""Niguarda Cancer Center, Ospedale Niguarda Ca' Granda, Milan.""}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Carlo-Stella', 'Affiliation': 'Department of Oncology and Hematology, Humanitas Cancer Center, Humanitas Clinical and Research Center, Rozzano; Department of Medical Biotechnology and Translational Medicine.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Pizzocaro', 'Affiliation': 'Department of Surgery, Urology Unit, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Salvioni', 'Affiliation': 'Department of Surgery, Urology Unit, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan.'}, {'ForeName': 'A M', 'Initials': 'AM', 'LastName': 'Gianni', 'Affiliation': 'Department of Medical Oncology; Department of Pathophysiology and Transplantation, University of Milano, Milan, Italy.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdu485'] 1391,32420683,"Discovery of Intake Biomarkers of Lentils, Chickpeas, and White Beans by Untargeted LC-MS Metabolomics in Serum and Urine.","SCOPE To identify reliable biomarkers of food intake (BFIs) of pulses. METHODS AND RESULTS A randomized crossover postprandial intervention study is conducted on 11 volunteers who consumed lentils, chickpeas, and white beans. Urine and serum samples are collected at distinct postprandial time points up to 48 h, and analyzed by LC-HR-MS untargeted metabolomics. Hypaphorine, trigonelline, several small peptides, and polyphenol-derived metabolites prove to be the most discriminating urinary metabolites. Two arginine-related compounds, dopamine sulfate and epicatechin metabolites, with their microbial derivatives, are identified only after intake of lentils, whereas protocatechuic acid is identified only after consumption of chickpeas. Urinary hydroxyjasmonic and hydroxydihydrojasmonic acids, as well as serum pipecolic acid and methylcysteine, are found after white bean consumption. Most of the metabolites identified in the postprandial study are replicated as discriminants in 24 h urine samples, demonstrating that in this case the use of a single, noninvasive sample is suitable for revealing the consumption of pulses. CONCLUSIONS The results of the present untargeted metabolomics work reveals a broad list of metabolites that are candidates for use as biomarkers of pulse intake. Further studies are needed to validate these BFIs and to find the best combinations of them to boost their specificity.",2020,"Urinary hydroxyjasmonic and hydroxydihydrojasmonic acids, as well as serum pipecolic acid and methylcysteine, were found after white bean consumption.","['11 volunteers who consumed lentils, chickpeas and white beans']","['Hypaphorine, trigonelline', 'dopamine sulfate and epicatechin metabolites']",['Urine and serum samples'],"[{'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0023323', 'cui_str': 'Lentils'}, {'cui': 'C0950052', 'cui_str': 'Chick peas'}, {'cui': 'C0446305', 'cui_str': 'White bean'}]","[{'cui': 'C0064754', 'cui_str': 'lenticin'}, {'cui': 'C0077132', 'cui_str': 'trigonelline'}, {'cui': 'C0013030', 'cui_str': 'Dopamine'}, {'cui': 'C0038720', 'cui_str': 'Inorganic sulfate'}, {'cui': 'C0014485', 'cui_str': '(-)-Epicatechin'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}]","[{'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C1550100', 'cui_str': 'Serum specimen'}]",11.0,0.0132396,"Urinary hydroxyjasmonic and hydroxydihydrojasmonic acids, as well as serum pipecolic acid and methylcysteine, were found after white bean consumption.","[{'ForeName': 'Mar', 'Initials': 'M', 'LastName': 'Garcia-Aloy', 'Affiliation': 'Biomarkers and Nutrimetabolomics Laboratory, Department of Nutrition, Food Sciences and Gastronomy, XaRTA, INSA, Faculty of Pharmacy and Food Sciences, University of Barcelona, Barcelona, 08028, Spain.'}, {'ForeName': 'Marynka', 'Initials': 'M', 'LastName': 'Ulaszewska', 'Affiliation': 'IRCCS San Raffaele Scientific Institute, Center for Omics Sciences, Proteomics and Metabolomics Facility - ProMeFa, Milan, 20132, Italy.'}, {'ForeName': 'Pietro', 'Initials': 'P', 'LastName': 'Franceschi', 'Affiliation': ""Computational Biology Unit, Research and Innovation Center, Fondazione Edmund Mach, San Michele all'Adige, 38010, Italy.""}, {'ForeName': 'Sheila', 'Initials': 'S', 'LastName': 'Estruel-Amades', 'Affiliation': 'Biomarkers and Nutrimetabolomics Laboratory, Department of Nutrition, Food Sciences and Gastronomy, XaRTA, INSA, Faculty of Pharmacy and Food Sciences, University of Barcelona, Barcelona, 08028, Spain.'}, {'ForeName': 'Christoph H', 'Initials': 'CH', 'LastName': 'Weinert', 'Affiliation': 'Department of Safety and Quality of Fruit and Vegetables, Max Rubner-Institut, Federal Research Institute of Nutrition and Food, Karlsruhe, 76131, Germany.'}, {'ForeName': 'Alba', 'Initials': 'A', 'LastName': 'Tor-Roca', 'Affiliation': 'Biomarkers and Nutrimetabolomics Laboratory, Department of Nutrition, Food Sciences and Gastronomy, XaRTA, INSA, Faculty of Pharmacy and Food Sciences, University of Barcelona, Barcelona, 08028, Spain.'}, {'ForeName': 'Mireia', 'Initials': 'M', 'LastName': 'Urpi-Sarda', 'Affiliation': 'Biomarkers and Nutrimetabolomics Laboratory, Department of Nutrition, Food Sciences and Gastronomy, XaRTA, INSA, Faculty of Pharmacy and Food Sciences, University of Barcelona, Barcelona, 08028, Spain.'}, {'ForeName': 'Fulvio', 'Initials': 'F', 'LastName': 'Mattivi', 'Affiliation': ""Department of Food Quality and Nutrition, Research and Innovation Center, Fondazione Edmund Mach (FEM), San Michele all'Adige, 38010, Italy.""}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Andres-Lacueva', 'Affiliation': 'Biomarkers and Nutrimetabolomics Laboratory, Department of Nutrition, Food Sciences and Gastronomy, XaRTA, INSA, Faculty of Pharmacy and Food Sciences, University of Barcelona, Barcelona, 08028, Spain.'}]",Molecular nutrition & food research,['10.1002/mnfr.201901137'] 1392,25355716,Expression of secreted protein acidic and rich in cysteine (SPARC) in breast cancer and response to neoadjuvant chemotherapy.,"BACKGROUND Secreted protein acidic and rich in cysteine (SPARC) has been suggested as a new biomarker and therapeutic target in breast cancer, as well as other tumor types. PATIENTS AND METHODS We evaluated the frequency of SPARC expression among different molecular breast cancer subtypes and its role for therapy response after neoadjuvant chemotherapy. In this study, pretherapeutic core biopsies of 667 patients from the neoadjuvant GeparTrio trial were evaluated for SPARC expression by immunohistochemistry using a standardized immunoreactive score (IRS). RESULTS An increased SPARC expression (IRS ≥6) was observed in 26% of all tumors. In triple-negative tumors, SPARC expression was increased in 37% of tumors, compared with other molecular subtypes (23% HR+/HER2-, 29% HR+/HER2+ and 22% HR-/HER2+; P = 0.038). Increased SPARC expression was associated with an increased pathological complete response (pCR) rate of 27%, compared with 15% in tumors with low SPARC expression (P < 0.001). In the triple-negative subgroup, pCR rates were 47% in tumors with high SPARC expression, compared with 26% in tumors with low SPARC expression (P = 0.032). In multivariable analysis, SPARC was independently predictive in the overall population (P = 0.010) as well as the triple-negative subgroup (P = 0.036). CONCLUSIONS SPARC is frequently expressed in breast cancer with triple-negative breast cancer revealing the highest expression rate. High SPARC expression of the primary tumor is associated with a higher chance of achieving a pathological complete remission after TAC or TAC-NX chemotherapy. As SPARC is an albumin-binding protein and might mediate intratumoral accumulation of albumin bound drugs, SPARC should be further evaluated as a predictive marker especially for response to albumin-bound drugs like nab-paclitaxel. CLINICAL TRIAL NUMBER NCT00544765.",2015,"In multivariable analysis, SPARC was independently predictive in the overall population (P = 0.010) as well as the triple-negative subgroup (P = 0.036). ",['667 patients from the neoadjuvant GeparTrio trial'],"['Secreted protein acidic and rich in cysteine (SPARC', 'neoadjuvant chemotherapy', 'secreted protein acidic and rich in cysteine (SPARC']","['SPARC expression', 'Increased SPARC expression', 'SPARC expression (IRS ≥6', 'SPARC expression by immunohistochemistry using a standardized immunoreactive score (IRS', 'pCR rates', 'pathological complete response (pCR) rate']","[{'cui': 'C4517851', 'cui_str': '667 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0699759', 'cui_str': 'Wealthy (finding)'}, {'cui': 'C0010654', 'cui_str': 'L-cysteine'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0021044', 'cui_str': 'Immunohistochemistry'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C3853643', 'cui_str': 'Probe with target amplification technique (qualifier value)'}, {'cui': 'C1521733', 'cui_str': 'Pathologic (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]",667.0,0.0729965,"In multivariable analysis, SPARC was independently predictive in the overall population (P = 0.010) as well as the triple-negative subgroup (P = 0.036). ","[{'ForeName': 'J L', 'Initials': 'JL', 'LastName': 'Lindner', 'Affiliation': 'Institute of Pathology, Charité-Universitätsmedizin Berlin, Berlin.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Loibl', 'Affiliation': 'German Breast Group, Neu-Isenburg; Department of Oncology, Klinikum Offenbach, Offenbach.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Denkert', 'Affiliation': 'Institute of Pathology, Charité-Universitätsmedizin Berlin, Berlin. Electronic address: carsten.denkert@charite.de.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Ataseven', 'Affiliation': 'Department of Gynecology, Kliniken-Essen-Mitte, Essen.'}, {'ForeName': 'P A', 'Initials': 'PA', 'LastName': 'Fasching', 'Affiliation': 'Department of Gynecology and Obstetrics, University Hospital Erlangen, Comprehensive Cancer Center Erlangen-EMN, Friedrich-Alexander University Erlangen-Nuremberg, Erlangen.'}, {'ForeName': 'B M', 'Initials': 'BM', 'LastName': 'Pfitzner', 'Affiliation': 'Institute of Pathology, Charité-Universitätsmedizin Berlin, Berlin.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Gerber', 'Affiliation': 'Department of Gynecology, Klinikum Südstadt Rostock, Rostock.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Gade', 'Affiliation': 'German Breast Group, Neu-Isenburg.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Darb-Esfahani', 'Affiliation': 'Institute of Pathology, Charité-Universitätsmedizin Berlin, Berlin.'}, {'ForeName': 'B V', 'Initials': 'BV', 'LastName': 'Sinn', 'Affiliation': 'Institute of Pathology, Charité-Universitätsmedizin Berlin, Berlin.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Huober', 'Affiliation': 'Department of Obstetrics and Gynecology, Universitätsklinikum Ulm, Ulm.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Engels', 'Affiliation': 'Department of Pathology, Zentrum für Pathologie, Zytologie und Molekularpathologie, Neuss.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Tesch', 'Affiliation': 'Oncological Center, Bethanien-Hospital, Frankfurt am Main.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Karn', 'Affiliation': 'Department of Obstetrics and Gynecology, Goethe-Universität, Frankfurt/Main.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Pommerenke', 'Affiliation': 'Institute of Pathology, Klinikum Südstadt, Rostock.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Liedtke', 'Affiliation': 'Department of Obstetrics and Gynecology, Universitätsklinikum Schleswig-Holstein, Lübeck.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Untch', 'Affiliation': 'Department of Obstetrics and Gynecology, Helios Klinikum Berlin-Buch, Berlin.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Müller', 'Affiliation': 'Department of Gynecology, Universitätsklinikum Hamburg-Eppendorf, Hamburg.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Rack', 'Affiliation': 'Department of Obstetrics and Gynecology, Ludwig-Maximilians-Universität München, München.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Schem', 'Affiliation': 'Department of Obstetrics and Gynecology, Universitätsklinikum Schleswig-Holstein, Campus Kiel, Kiel, Germany.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'von Minckwitz', 'Affiliation': 'German Breast Group, Neu-Isenburg; Department of Obstetrics and Gynecology, Goethe-Universität, Frankfurt/Main.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdu487'] 1393,31430755,Cognitive Behaviour Therapy Complemented with Emotion Regulation Training for Patients with Persistent Physical Symptoms: A Randomised Clinical Trial.,"INTRODUCTION Persistent medically unexplained symptoms (MUS) are a major burden for health care. Cognitive behaviour therapy (CBT) is efficacious for patients with MUS, with small to medium effects. The current study investigates whether therapy outcomes of a CBT for MUS patients can be improved by complementing it with emotion regulation training. METHODS In a multicentre trial 255 patients with at least three persisting MUS were randomised to 20 sessions of either conventional CBT (n = 128) or CBT complemented with emotion regulation training (ENCERT; n = 127). Somatic symptom severity and secondary outcomes were assessed at pre-treatment, therapy session 8, end of therapy, and 6-month follow-up. RESULTS Linear mixed-effect models revealed medium to large effects in both study arms for almost all outcomes at the end of therapy and 6-month follow-up. ENCERT and CBT did not differ in their effect on the primary outcome (d = 0.20, 95% CI: -0.04 to 0.44). Significant time × group cross-level interactions suggested ENCERT to be of more benefit than conventional CBT for a few secondary outcomes. Moderator analyses revealed higher effects of ENCERT in patients with co-morbid mental disorders. DISCUSSION/CONCLUSIONS Current findings are based on a representative sample. Results demonstrate that both CBT and ENCERT can achieve strong effects on primary and secondary outcomes in MUS patients. Our results do not indicate that adding a training in emotion regulation skills generally improves the effect of CBT across all patients with MUS. Large effect sizes of both treatments and potential specific benefits of ENCERT for patients with co-morbid mental disorders are discussed.",2019,ENCERT and CBT did not differ in their effect on the primary outcome (,"['patients with co-morbid mental disorders', 'MUS patients', 'patients with MUS', 'Patients with Persistent Physical Symptoms', '255 patients with at least three persisting MUS']","['ENCERT and CBT', 'CBT complemented with emotion regulation training (ENCERT', 'Cognitive behaviour therapy (CBT', 'Cognitive Behaviour Therapy Complemented with Emotion Regulation Training', 'ENCERT', 'CBT and ENCERT', 'conventional CBT']",[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder (disorder)'}, {'cui': 'C0026809', 'cui_str': 'Mice'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]","[{'cui': 'C0009498', 'cui_str': 'Complement System Proteins'}, {'cui': 'C0013987', 'cui_str': 'Emotions'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}]",[],255.0,0.0637433,ENCERT and CBT did not differ in their effect on the primary outcome (,"[{'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Kleinstäuber', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Philipps University, Marburg, Germany, maria.kleinstaeuber@staff.uni-marburg.de.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Allwang', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, Klinikum rechts der Isar, Technical University of Munich, Munich, Germany.'}, {'ForeName': 'Josef', 'Initials': 'J', 'LastName': 'Bailer', 'Affiliation': 'Department of Clinical Psychology, Central Institute of Mental Health, Medical Faculty Mannheim, Heidelberg University, Heidelberg, Germany.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Berking', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Friedrich Alexander University, Erlangen, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Brünahl', 'Affiliation': 'Institute and Outpatients Clinic for Psychosomatic Medicine and Psychotherapy, University Medical Centre Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Maja', 'Initials': 'M', 'LastName': 'Erkic', 'Affiliation': 'Department of Clinical Psychology, Central Institute of Mental Health, Medical Faculty Mannheim, Heidelberg University, Heidelberg, Germany.'}, {'ForeName': 'Harald', 'Initials': 'H', 'LastName': 'Gitzen', 'Affiliation': 'School of Human and Social Sciences, University of Wuppertal, Wuppertal, Germany.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Gollwitzer', 'Affiliation': 'Department of Social Psychology, Ludwig Maximilian University, Munich, Germany.'}, {'ForeName': 'Japhia-Marie', 'Initials': 'JM', 'LastName': 'Gottschalk', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Philipps University, Marburg, Germany.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Heider', 'Affiliation': 'Outpatient Clinic for Psychotherapy, University of Koblenz-Landau, Landau, Germany.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Hermann', 'Affiliation': 'Department of Psychotherapy and Systems Neuroscience, Justus Liebig University of Giessen, Giessen, Germany.'}, {'ForeName': 'Claas', 'Initials': 'C', 'LastName': 'Lahmann', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, University Medical Centre Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Bernd', 'Initials': 'B', 'LastName': 'Löwe', 'Affiliation': 'Institute and Outpatients Clinic for Psychosomatic Medicine and Psychotherapy, University Medical Centre Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Martin', 'Affiliation': 'School of Human and Social Sciences, University of Wuppertal, Wuppertal, Germany.'}, {'ForeName': 'Jörn', 'Initials': 'J', 'LastName': 'Rau', 'Affiliation': 'Coordinating Centre for Clinical Trials, Philipps University, Marburg, Germany.'}, {'ForeName': 'Annette', 'Initials': 'A', 'LastName': 'Schröder', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, University of Koblenz-Landau, Landau, Germany.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Schwabe', 'Affiliation': 'Department of Social Psychology, Ludwig Maximilian University, Munich, Germany.'}, {'ForeName': 'Jeanine', 'Initials': 'J', 'LastName': 'Schwarz', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Philipps University, Marburg, Germany.'}, {'ForeName': 'Rudolf', 'Initials': 'R', 'LastName': 'Stark', 'Affiliation': 'Department of Psychotherapy and Systems Neuroscience, Justus Liebig University of Giessen, Giessen, Germany.'}, {'ForeName': 'Frauke Dorothee', 'Initials': 'FD', 'LastName': 'Weiss', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Philipps University, Marburg, Germany.'}, {'ForeName': 'Winfried', 'Initials': 'W', 'LastName': 'Rief', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Philipps University, Marburg, Germany.'}]",Psychotherapy and psychosomatics,['10.1159/000501621'] 1394,31321887,Index participant characteristics and HIV assisted partner services efficacy in Kenya: results of a cluster randomized trial.,"INTRODUCTION We have previously demonstrated that assisted partner services (aPS) increases HIV testing and case finding among partners of persons living with HIV (PLHIV) in a cluster randomized trial in Kenya. However, the efficacy of aPS may vary across populations. In this analysis, we explore differences in aPS efficacy by characteristics of index participants. METHODS Eighteen HIV testing sites were randomized to immediate versus 6-week delayed aPS. Participants were PLHIV (or index participants) and their sexual partners. Partners of index participants were contacted for HIV testing and linked to care if HIV positive. Primary outcomes were the number of partners per index participant who: 1) tested for HIV, 2) tested HIV positive and 3) enrolled in HIV care. We used generalized estimating equations to assess differences in aPS efficacy by region, testing location, gender, age and knowledge of HIV status. RESULTS From 2013 to 2015, the study enrolled 1119 index participants, 625 of whom were in the immediate group. These index participants named 1286 sexual partners. Immediate aPS was more efficacious than delayed aPS in promoting HIV testing among partners in high compared to low HIV prevalence regions (Nyanza incidence rate ratio (IRR) 7.2; 95% confidence interval (CI) 5.4, 9.6 vs. Nairobi/Central IRR 3.4 95% CI 2.3, 4.8). Higher rates of partner HIV testing were also observed for index participants in rural/peri-urban compared to urban sites (IRR 6.6; 95% CI 4.5, 9.6 vs. IRR 3.5 95% CI 2.5, 5.0 respectively), for female versus male index participants (IRR 5.8 95% CI 4.2, 7.9 vs. IRR 3.7; 95% CI 2.4, 5.8 respectively) and for newly diagnosed versus known HIV-positive index participants (IRR 6.0 95% CI 4.2, 8.7 vs. IRR 3.3; 95% CI 2.0, 7.7 respectively). Providing aPS to female versus male index participants also had a significantly higher HIV case finding rate (IRR 9.1; 95% CI 4.0, 20.9 vs. IRR 3.2 95% CI 1.7, 6.0 respectively.) CONCLUSIONS: While it is known that aPS promotes increases in HIV testing and case finding, this is the first study to demonstrate significant differences in aPS efficacy across characteristics of the index participant. Understanding these differences and their drivers will be critical as aPS is brought to scale in order to ensure all PLHIV have access to these services.",2019,"Immediate aPS was more efficacious than delayed aPS in promoting HIV testing among partners in high compared to low HIV prevalence regions (Nyanza incidence rate ratio (IRR) 7.2; 95% confidence interval (CI) 5.4, 9.6 vs. Nairobi/Central IRR 3.4 95% CI 2.3, 4.8).","['persons living with HIV (PLHIV) in a cluster randomized trial in Kenya', 'Eighteen HIV testing sites', 'Kenya', 'Participants were PLHIV (or index participants) and their sexual partners', 'These index participants named 1286 sexual partners', 'From 2013 to 2015, the study enrolled 1119 index participants, 625 of whom were in the immediate group']","['immediate versus 6-week delayed aPS', 'assisted partner services (aPS']","['number of partners per index participant who: 1) tested for HIV, 2) tested HIV positive and 3) enrolled in HIV care', 'Higher rates of partner HIV testing', 'aPS efficacy']","[{'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0022558', 'cui_str': 'Republic of Kenya'}, {'cui': 'C3715206', 'cui_str': 'Eighteen'}, {'cui': 'C1321876', 'cui_str': 'Human immunodeficiency virus test (procedure)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0036911', 'cui_str': 'Sexual Partners'}, {'cui': 'C4522128', 'cui_str': 'Name (property)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C4517838', 'cui_str': 'Six hundred and twenty-five'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0085409', 'cui_str': 'Polyendocrinopathies, Autoimmune'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0682323', 'cui_str': 'Companion'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0682323', 'cui_str': 'Companion'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0019699', 'cui_str': 'HTLV-III Seroconversion'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0085409', 'cui_str': 'Polyendocrinopathies, Autoimmune'}]",1119.0,0.212368,"Immediate aPS was more efficacious than delayed aPS in promoting HIV testing among partners in high compared to low HIV prevalence regions (Nyanza incidence rate ratio (IRR) 7.2; 95% confidence interval (CI) 5.4, 9.6 vs. Nairobi/Central IRR 3.4 95% CI 2.3, 4.8).","[{'ForeName': 'Sarah J', 'Initials': 'SJ', 'LastName': 'Masyuko', 'Affiliation': 'National AIDS and STI Control Program, Ministry of Health, Nairobi, Kenya.'}, {'ForeName': 'Peter K', 'Initials': 'PK', 'LastName': 'Cherutich', 'Affiliation': 'Department of Preventive and Promotive Health Services, Ministry of Health, Nairobi, Kenya.'}, {'ForeName': 'Marielle G', 'Initials': 'MG', 'LastName': 'Contesse', 'Affiliation': 'Department of Epidemiology, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Peter M', 'Initials': 'PM', 'LastName': 'Maingi', 'Affiliation': 'VCT and HIV Prevention Unit, Kenyatta National Hospital, Nairobi, Kenya.'}, {'ForeName': 'Beatrice M', 'Initials': 'BM', 'LastName': 'Wamuti', 'Affiliation': 'Department of Research and Programs, Kenyatta National Hospital, Nairobi, Kenya.'}, {'ForeName': 'Paul M', 'Initials': 'PM', 'LastName': 'Macharia', 'Affiliation': 'National AIDS and STI Control Program, Ministry of Health, Nairobi, Kenya.'}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Bukusi', 'Affiliation': 'VCT and HIV Prevention Unit, Kenyatta National Hospital, Nairobi, Kenya.'}, {'ForeName': 'Felix A', 'Initials': 'FA', 'LastName': 'Otieno', 'Affiliation': 'Department of Research and Programs, Kenyatta National Hospital, Nairobi, Kenya.'}, {'ForeName': 'Hans Ml', 'Initials': 'HM', 'LastName': 'Spiegel', 'Affiliation': 'Department of Health and Human Services, Kelly Government Solutions, Contractor to National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, MD, USA.'}, {'ForeName': 'Matthew D', 'Initials': 'MD', 'LastName': 'Dunbar', 'Affiliation': 'Department of Computer Science and Demography, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Matthew R', 'Initials': 'MR', 'LastName': 'Golden', 'Affiliation': 'Department of Medicine, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Barbra A', 'Initials': 'BA', 'LastName': 'Richardson', 'Affiliation': 'Department of Global Health, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Carey', 'Initials': 'C', 'LastName': 'Farquhar', 'Affiliation': 'Department of Global Health, University of Washington, Seattle, WA, USA.'}]",Journal of the International AIDS Society,['10.1002/jia2.25305'] 1395,31957648,A pilot randomized controlled trial of cognitive behavioral treatment for trauma-related nightmares in active duty military personnel.,"STUDY OBJECTIVES The aim of this study was to obtain preliminary data on the efficacy, credibility, and acceptability of Exposure, relaxation, and rescripting therapy for military service members and veterans (ERRT-M) in active duty military personnel with trauma-related nightmares. METHODS Forty participants were randomized to either 5 sessions of ERRT-M or 5 weeks of minimal contact control (MCC) followed by ERRT-M. Assessments were completed at baseline, posttreatment/postcontrol, and 1-month follow-up. RESULTS Differences between ERRT-M and control were generally medium in size for nightmare frequency (Cohen d = -0.53), nights with nightmares (d = -0.38), nightmare severity (d = -0.60), fear of sleep (d = -0.44), and symptoms of insomnia (d = -0.52), and depression (d = -0.51). In the 38 participants who received ERRT-M, there were statistically significant, medium-sized decreases in nightmare frequency (d = -0.52), nights with nightmares (d = -0.50), nightmare severity (d = -0.55), fear of sleep (d = -0.48), and symptoms of insomnia (d = -0.59), posttraumatic stress disorder (PTSD) (d = -0.58) and depression (d = -0.59) from baseline to 1-month follow-up. Participants generally endorsed medium to high ratings of treatment credibility and expectancy. The treatment dropout rate (17.5%) was comparable to rates observed for similar treatments in civilians. CONCLUSIONS ERRT-M produced medium effect-size reductions in nightmares and several secondary outcomes including PTSD, depression, and insomnia. Participants considered ERRT-M to be credible. An adequately powered randomized clinical trial is needed to confirm findings and to compare ERRT-M to an active treatment control. CLINICAL TRIAL REGISTRATION Registry: ClinicalTrials.gov; Title: A Pilot Randomized Controlled Trial of Treatment for Trauma-Related Nightmares In Active Duty Military Personnel; Identifier: NCT02506595; URL: https://clinicaltrials.gov/ct2/show/NCT02506595.",2020,"CONCLUSIONS ERRT-M produced medium effect-size reductions in nightmares and several secondary outcomes including PTSD, depression, and insomnia.","['military service members and veterans (ERRT-M) in active duty military personnel with trauma-related nightmares', 'Forty participants', 'trauma-related nightmares in active duty military personnel', 'Trauma-Related Nightmares']","['ERRT-M or 5 weeks of minimal contact control (MCC) followed by ERRT-M. Assessments were completed at baseline, posttreatment/postcontrol, and 1-month follow-up', 'cognitive behavioral treatment']","['efficacy, credibility, and acceptability of Exposure, relaxation', 'treatment dropout rate', 'nightmare frequency', 'symptoms of insomnia', 'PTSD, depression, and insomnia', 'fear of sleep', 'posttraumatic stress disorder (PTSD', 'nights with nightmares', 'nightmare severity']","[{'cui': 'C0336524', 'cui_str': 'Military services member'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C3831794', 'cui_str': 'Active duty military'}, {'cui': 'C0043251', 'cui_str': 'Trauma'}, {'cui': 'C0028084', 'cui_str': 'Nightmares'}]","[{'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0547040', 'cui_str': 'Minimal (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0028084', 'cui_str': 'Nightmares'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}]",40.0,0.135922,"CONCLUSIONS ERRT-M produced medium effect-size reductions in nightmares and several secondary outcomes including PTSD, depression, and insomnia.","[{'ForeName': 'Kristi E', 'Initials': 'KE', 'LastName': 'Pruiksma', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Texas Health Science Center at San Antonio, San Antonio, Texas.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Taylor', 'Affiliation': 'Department of Psychology, University of North Texas, Denton, Texas.'}, {'ForeName': 'Jim', 'Initials': 'J', 'LastName': 'Mintz', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Texas Health Science Center at San Antonio, San Antonio, Texas.'}, {'ForeName': 'Karin L', 'Initials': 'KL', 'LastName': 'Nicholson', 'Affiliation': 'Department of Medicine, Carl R. Darnall Army Medical Center, Fort Hood, Texas.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Rodgers', 'Affiliation': 'Department of Medicine, Carl R. Darnall Army Medical Center, Fort Hood, Texas.'}, {'ForeName': 'Stacey', 'Initials': 'S', 'LastName': 'Young-McCaughan', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Texas Health Science Center at San Antonio, San Antonio, Texas.'}, {'ForeName': 'Brittany N', 'Initials': 'BN', 'LastName': 'Hall-Clark', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Texas Health Science Center at San Antonio, San Antonio, Texas.'}, {'ForeName': 'Brooke A', 'Initials': 'BA', 'LastName': 'Fina', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Texas Health Science Center at San Antonio, San Antonio, Texas.'}, {'ForeName': 'Katherine A', 'Initials': 'KA', 'LastName': 'Dondanville', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Texas Health Science Center at San Antonio, San Antonio, Texas.'}, {'ForeName': 'Briana', 'Initials': 'B', 'LastName': 'Cobos', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Texas Health Science Center at San Antonio, San Antonio, Texas.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Wardle-Pinkston', 'Affiliation': 'Department of Psychology, University of North Texas, Denton, Texas.'}, {'ForeName': 'Brett T', 'Initials': 'BT', 'LastName': 'Litz', 'Affiliation': 'Massachusetts Veterans Epidemiological Research and Information Center VA Boston Healthcare System, Boston, Massachusetts.'}, {'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Roache', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Texas Health Science Center at San Antonio, San Antonio, Texas.'}, {'ForeName': 'Alan L', 'Initials': 'AL', 'LastName': 'Peterson', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Texas Health Science Center at San Antonio, San Antonio, Texas.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine,['10.5664/jcsm.8116'] 1396,31362145,The impact of uncontrollability beliefs and thought-related distress on ecological momentary interventions for generalized anxiety disorder: A moderated mediation model.,"This study was a secondary analysis of LaFreniere and Newman (2016), a randomized controlled trial comparing two ecological momentary interventions (EMIs) for generalized anxiety disorder (GAD): The worry outcome journal (WOJ) and thought log (TL). We predicted that higher thought-related distress would be a mediator by which higher uncontrollability beliefs (UB) would hinder the efficacy of the WOJ, but not the TL. Fifty-one undergraduates who met GAD criteria underwent one of the EMIs for 10 days. WOJ users tracked worries, associated distress, interference, expected outcome probabilities, and whether their worries came true four times/day. TL users tracked general thoughts, associated distress, and interference four times/day. Bootstrapping path analysis was used to analyze moderated mediation models. Higher UB predicted higher thought-related distress for both EMIs. Higher UB also predicted reduced efficacy of the WOJ at post-trial and of both EMIs at 30-day follow-up. However, for WOJ users, when higher initial UB levels predicted higher thought-related distress early in treatment, participants reported greater levels of worry at post-trial and follow-up. In contrast, UB's effect on the TL group at post-trial and follow-up was not mediated by early distress. Thought-related distress appears to be a mechanism by which UB impedes the WOJ intervention.",2019,Higher UB also predicted reduced efficacy of the WOJ at post-trial and of both EMIs at 30-day follow-up.,"['Fifty-one undergraduates who met GAD criteria underwent one of the EMIs for 10 days', 'generalized anxiety disorder', 'generalized anxiety disorder (GAD', 'LaFreniere and Newman (2016']","['ecological momentary interventions', 'TL', 'ecological momentary interventions (EMIs']",['worry outcome journal (WOJ) and thought log (TL'],"[{'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0270549', 'cui_str': 'Generalized anxiety disorder (disorder)'}]",[],"[{'cui': 'C0233481', 'cui_str': 'Worried (finding)'}, {'cui': 'C4319827', 'cui_str': 'Thought'}]",,0.078939,Higher UB also predicted reduced efficacy of the WOJ at post-trial and of both EMIs at 30-day follow-up.,"[{'ForeName': 'Lucas S', 'Initials': 'LS', 'LastName': 'LaFreniere', 'Affiliation': 'The Pennsylvania State University, United States. Electronic address: lsl141@psu.edu.'}, {'ForeName': 'Michelle G', 'Initials': 'MG', 'LastName': 'Newman', 'Affiliation': 'The Pennsylvania State University, United States.'}]",Journal of anxiety disorders,['10.1016/j.janxdis.2019.102113'] 1397,32040244,Effectiveness of enhanced cognitive behavior therapy for eating disorders: A randomized controlled trial.,"OBJECTIVE Enhanced cognitive behavior therapy (CBT-E) is a transdiagnostic treatment suitable for the full range of eating disorders (EDs). Although the effectiveness of CBT(-E) is clear, it is not being used as widely in clinical practice as guidelines recommend. The aim of the present study was to compare the effectiveness of CBT-E with treatment as usual (TAU), which was largely based on CBT principles. METHOD We conducted a randomized controlled trial on a total of 143 adult patients with an ED who received either CBT-E or TAU. The primary outcome was recovery from the ED. Secondary outcome measures were levels of ED psychopathology, anxiety, and depressive symptoms. Self-esteem, perfectionism, and interpersonal problems were repeatedly measured to examine possible moderating effects. We explored differences in duration and intensity between conditions. RESULTS After 80 weeks, there were no differences between conditions in decrease in ED psychopathology, or symptoms of anxiety and depression. However, in the first six weeks of treatment there was a larger decrease in ED psychopathology in the CBT-E condition. Moreover, when the internationally most widely used definition of recovery was applied, the recovery rate at 20 weeks of CBT-E was significantly higher (57.7%) than of TAU (36.0%). At 80 weeks, this difference was no longer significant (CBT-E 60.9%; TAU 43.6%). Furthermore, CBT-E was more effective in improving self-esteem and was also the less intensive and shorter treatment. DISCUSSION With broader use of CBT-E, the efficiency, accessibility and effectivity (on self-esteem) of treatment for EDs could be improved.",2020,"Furthermore, CBT-E was more effective in improving self-esteem and was also the less intensive and shorter treatment. ","['143 adult patients with an ED who received either', 'eating disorders']","['enhanced cognitive behavior therapy', 'CBT-E or TAU', 'CBT(-E', 'CBT-E', 'cognitive behavior therapy (CBT-E']","['recovery rate', 'Self-esteem, perfectionism, and interpersonal problems', 'levels of ED psychopathology, anxiety, and depressive symptoms', 'self-esteem', 'efficiency, accessibility and effectivity', 'recovery from the ED', 'ED psychopathology, or symptoms of anxiety and depression', 'ED psychopathology']","[{'cui': 'C4517573', 'cui_str': 'One hundred and forty-three'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0013473', 'cui_str': 'Eating Disorders'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C1720655', 'cui_str': 'Tau'}]","[{'cui': 'C0036597', 'cui_str': 'Self Esteem'}, {'cui': 'C0815110', 'cui_str': 'Perfectionism'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0033927', 'cui_str': 'Psychopathology'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}]",143.0,0.132319,"Furthermore, CBT-E was more effective in improving self-esteem and was also the less intensive and shorter treatment. ","[{'ForeName': 'Martie', 'Initials': 'M', 'LastName': 'de Jong', 'Affiliation': 'Center for Eating Disorders, PsyQ, Part of Parnassia Psychiatric Institute, The Hague, The Netherlands.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Spinhoven', 'Affiliation': 'Institute of Psychology, Leiden University, Leiden, The Netherlands.'}, {'ForeName': 'Kees', 'Initials': 'K', 'LastName': 'Korrelboom', 'Affiliation': 'Parnassia Psychiatric Institute, The Hague, The Netherlands.'}, {'ForeName': 'Mathijs', 'Initials': 'M', 'LastName': 'Deen', 'Affiliation': 'Parnassia Psychiatric Institute, The Hague, The Netherlands.'}, {'ForeName': 'Iris', 'Initials': 'I', 'LastName': 'van der Meer', 'Affiliation': 'Center for Eating Disorders, PsyQ, Part of Parnassia Psychiatric Institute, The Hague, The Netherlands.'}, {'ForeName': 'Unna N', 'Initials': 'UN', 'LastName': 'Danner', 'Affiliation': 'Altrecht Eating Disorders Rintveld, Zeist, The Netherlands.'}, {'ForeName': 'Selma', 'Initials': 'S', 'LastName': 'van der Schuur', 'Affiliation': 'Center for Eating Disorders-PsyQ, Part of Lentis Psychiatric Institute, Groningen, The Netherlands.'}, {'ForeName': 'Maartje', 'Initials': 'M', 'LastName': 'Schoorl', 'Affiliation': 'Institute of Psychology, Leiden University, Leiden, The Netherlands.'}, {'ForeName': 'Hans W', 'Initials': 'HW', 'LastName': 'Hoek', 'Affiliation': 'Parnassia Psychiatric Institute, The Hague, The Netherlands.'}]",The International journal of eating disorders,['10.1002/eat.23239'] 1398,24945085,Guanfacine extended release adjunctive to a psychostimulant in the treatment of comorbid oppositional symptoms in children and adolescents with attention-deficit/hyperactivity disorder.,"OBJECTIVE The purpose of this study was to assess the effect of guanfacine extended release (GXR) adjunctive to a psychostimulant on oppositional symptoms in children and adolescents with attention-deficit/hyperactivity disorder (ADHD). METHODS A multicenter, double-blind, placebo-controlled dose-optimization study of GXR (1-4 mg/d) or placebo administered morning (a.m.) or evening (p.m.) adjunctive to psychostimulant was conducted in subjects ages 6-17 with suboptimal response to psychostimulant alone. Suboptimal response was defined as treatment with a stable dose of psychostimulant for ≥4 weeks with ADHD Rating Scale IV total score ≥24 and Clinical Global Impressions-Severity of Illness score ≥3, as well as investigator opinion. Primary efficacy and safety results have been reported previously. Secondary efficacy measures included the oppositional subscale of the Conners' Parent Rating Scale-Revised: Long Form (CPRS-R:L); these are reported herein. RESULTS Significant reductions from baseline to the final on-treatment assessment on the oppositional subscale of the CPRS-R:L were seen with GXR plus psychostimulant compared with placebo plus psychostimulant, both in the overall study population (placebo-adjusted least squares [LS] mean change from baseline to the final on-treatment assessment: GXR a.m.+psychostimulant, -2.4, p=0.001; GXR p.m.+psychostimulant, -2.2, p=0.003) as well as in the subgroup of subjects with significant baseline oppositional symptoms (GXR a.m.+psychostimulant, -3.6, p=0.001; GXR p.m.+psychostimulant, -2.7, p=0.013). Treatment-emergent adverse events were reported by 77.3%, 76.3%, and 63.4% of subjects in the GXR a.m., GXR p.m., and placebo groups, respectively, in the overall study population. CONCLUSIONS GXR adjunctive to a psychostimulant significantly reduced oppositional symptoms compared with placebo plus a psychostimulant in subjects with ADHD and a suboptimal response to psychostimulant alone.",2014,"RESULTS Significant reductions from baseline to the final on-treatment assessment on the oppositional subscale of the CPRS-R:","['subjects ages 6-17 with suboptimal response to psychostimulant alone', 'children and adolescents with attention-deficit/hyperactivity disorder (ADHD', 'subjects with ADHD', 'children and adolescents with attention-deficit/hyperactivity disorder']","['placebo', 'Guanfacine', 'psychostimulant', 'placebo administered morning (a.m.) or evening (p.m', 'placebo-adjusted least squares [LS', 'GXR', 'guanfacine extended release (GXR) adjunctive']","['oppositional subscale of the CPRS-R', 'oppositional symptoms', 'ADHD Rating Scale IV total score ≥24 and Clinical Global Impressions-Severity of Illness score ≥3', ""oppositional subscale of the Conners' Parent Rating Scale-Revised: Long Form (CPRS-R:L"", 'comorbid oppositional symptoms']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0304403', 'cui_str': 'Psychostimulant'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0079466', 'cui_str': 'Guanfacine'}, {'cui': 'C0304403', 'cui_str': 'Psychostimulant'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0332170', 'cui_str': 'Morning (qualifier value)'}, {'cui': 'C0587117', 'cui_str': 'Evening (qualifier value)'}, {'cui': 'C0023189', 'cui_str': 'Least Squares'}, {'cui': 'C0231449', 'cui_str': 'Extended (qualifier value)'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}]","[{'cui': 'C0860661', 'cui_str': 'Oppositional'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C0222045'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0221423', 'cui_str': 'Illness (finding)'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}]",,0.17963,"RESULTS Significant reductions from baseline to the final on-treatment assessment on the oppositional subscale of the CPRS-R:","[{'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Findling', 'Affiliation': '1 Department of Psychiatry, Johns Hopkins University and the Kennedy Krieger Institute , Baltimore, Maryland.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'McBurnett', 'Affiliation': ''}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'White', 'Affiliation': ''}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Youcha', 'Affiliation': ''}]",Journal of child and adolescent psychopharmacology,['10.1089/cap.2013.0103'] 1399,24766686,Can electronic web-based technology improve quality of life data collection? Analysis of Radiation Therapy Oncology Group 0828.,"PURPOSE Missing data are a significant problem in clinical trials, particularly for quality of life (QOL), which cannot be obtained retrospectively. The purpose of this study was to evaluate the feasibility of an electronic web-based strategy for QOL data collection in a cooperative group radiation oncology trial setting. METHODS AND MATERIALS Radiation Therapy Oncology Group (RTOG) 0828 was a prospective National Cancer Institute cooperative group companion study of RTOG-0415, a randomized study of conventional versus hypofractionated radiation. Forty-nine English-speaking patients with favorable risk prostate cancer who enrolled on RTOG-0415 consented to using web-based technology for completing QOL. In RTOG-0415, using paper forms, the 6-month QOL compliance rate was 52%. The purpose of RTOG-0828 was to test the feasibility of a web-based strategy with the goal of increasing the 6-month QOL completion rate by 25% (from 52% to 77%) for a relative improvement of ~50%. The web-based tool used in this study was VisionTree Optimal Care (VTOC; VisionTree Software, Inc, San Diego, CA), a Health-Insurance-Portability-Accountability-Act secure, online technology that allows real-time tracking and e-mail reminders. The primary endpoint was the 6-month compliance rate for the validated QOL instrument, Expanded Prostate Index Composite. RESULTS The QOL completion rate at baseline was 98%. Compared with the prior 52% QOL completion rate at 6 months using paper forms, the QOL web-based completion rate at 6 months was 90% (2-sided P value < .001). At 12 months, the EPIC completion rate was 82% (compared with 36% using paper forms). CONCLUSIONS This RTOG study suggests that a web-based strategy to collect QOL appears to be feasible in the cooperative group radiation oncology trial setting and is associated with an increase in the 6-month QOL compliance rate compared with the prior method of using paper forms. The RTOG plans to further test this strategy in a head-and-neck cancer trial across all participating RTOG sites.",2014,"At 12 months, the EPIC completion rate was 82% (compared with 36% using paper forms). ","['Forty-nine English-speaking patients with favorable risk prostate cancer who enrolled on RTOG-0415 consented to using web-based technology for completing QOL', 'Radiation Therapy Oncology Group (RTOG']",['conventional versus hypofractionated radiation'],"['QOL compliance rate', '6-month QOL completion rate', 'QOL completion rate', 'QOL web-based completion rate', '6-month compliance rate for the validated QOL instrument, Expanded Prostate Index Composite', 'EPIC completion rate', '6-month QOL compliance rate']","[{'cui': 'C3540738', 'cui_str': 'English [International Organization for Standardization 639-1 code en] language reference set (foundation metadata concept)'}, {'cui': 'C0234856', 'cui_str': 'Using spoken communication'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0034619', 'cui_str': 'radiation therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}]","[{'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C4551823', 'cui_str': 'instruments'}, {'cui': 'C0205229', 'cui_str': 'Expanding (qualifier value)'}, {'cui': 'C0033572', 'cui_str': 'Prostate'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}]",49.0,0.0658777,"At 12 months, the EPIC completion rate was 82% (compared with 36% using paper forms). ","[{'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Movsas', 'Affiliation': 'Henry Ford Health System, Detroit, Michigan. Electronic address: bmovsas1@hfhs.org.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Hunt', 'Affiliation': 'RTOG Statistical Center, Philadelphia, Pennsylvania.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Watkins-Bruner', 'Affiliation': 'Emory University School of Nursing, Atlanta, Georgia.'}, {'ForeName': 'W Robert', 'Initials': 'WR', 'LastName': 'Lee', 'Affiliation': 'Duke University School of Medicine, Durham, North Carolina.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Tharpe', 'Affiliation': 'Summa Health System Hospital, Akron, Ohio.'}, {'ForeName': 'Desiree', 'Initials': 'D', 'LastName': 'Goldstein', 'Affiliation': 'Kaiser Permanente Santa Clara Medical Center, Santa Clara, California.'}, {'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Moore', 'Affiliation': 'York Cancer Center, Hanover, Pennsylvania.'}, {'ForeName': 'Ian S', 'Initials': 'IS', 'LastName': 'Dayes', 'Affiliation': 'McMaster University, Juravinski Cancer Center Hamilton Health Sciences, Hamilton, Ontario, Canada.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Parise', 'Affiliation': 'North Shore-Long Island Jewish Health System, Monter Cancer Center, Lake Success, New York.'}, {'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'Sandler', 'Affiliation': 'Samuel Oschin Comprehensive Cancer Institute, Cedars-Sinai Medical Center, Los Angeles, California.'}]",Practical radiation oncology,['10.1016/j.prro.2013.07.014'] 1400,32040222,"A randomized pilot study of mindfulness-based stress reduction in a young adult cancer sample: Feasibility, acceptability, and changes in patient reported outcomes.","BACKGROUND The primary purpose of this study was to examine the feasibility and acceptability of participation in a randomized waitlist-controlled intervention of mindfulness-based stress reduction (MBSR) in a young adult cancer sample. A secondary aim was to examine patterns of change in patient reported outcomes (PROs) of physical, social, and emotional functioning. METHODS Participants were enrolled at a large Midwestern comprehensive cancer center and randomized to MBSR or a waitlist control. Feasibility and acceptability were examined through enrollment metrics and a survey. PROs were gathered at baseline, 8-weeks, and 16-weeks. Descriptive statistics and mixed models were used in analyses. RESULTS Of 597 eligible participants, 151 (26.5%) consented from which 126 (83.4%) completed baseline measures. Sixty-seven participants were randomized to MBSR, and 59 to the waitlist. Immediately following MBSR, the majority of respondents (72%-78%) reported their experience with mindfulness was very logical and useful to increasing their wellbeing. Compared to waitlist members, MBSR participant's scores on PROs improved in expected directions. CONCLUSIONS Our findings suggest that recruitment for an intensive, in-person, multi-week supportive intervention can be challenging with young adults with cancer, similar to other cancer survivor populations; however once enrolled, feasibility and acceptability of MBSR was supported. Further, initial evidence on the role of MBSR on short-term changes in select PROs with this population was also demonstrated.",2020,"Immediately following MBSR, the majority of respondents (72-78%) reported their experience with mindfulness was very logical and useful to increasing their wellbeing.","['Sixty-seven participants', 'Of 597 eligible participants, 151 (26.5', 'young adult cancer sample', 'Young Adult Cancer Sample', 'young adults with cancer', 'Participants were enrolled at a large Midwestern comprehensive cancer center and randomized to MBSR or a waitlist control']","['mindfulness-based stress reduction (MBSR', 'MBSR', 'Mindfulness-Based Stress Reduction']","['outcomes (PROs) of physical, social and emotional functioning', 'Feasibility and acceptability', 'Feasibility, Acceptability', 'PROs']","[{'cui': 'C4517852', 'cui_str': '67'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}]","[{'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}]",597.0,0.0358031,"Immediately following MBSR, the majority of respondents (72-78%) reported their experience with mindfulness was very logical and useful to increasing their wellbeing.","[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Victorson', 'Affiliation': 'Department of Medical Social Sciences, Northwestern University Feinberg School of Medicine, Chicago, Illinois.'}, {'ForeName': 'Karly', 'Initials': 'K', 'LastName': 'Murphy', 'Affiliation': 'Department of Medical Social Sciences, Northwestern University Feinberg School of Medicine, Chicago, Illinois.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Benedict', 'Affiliation': 'Psychiatry and Behavioral Services, Stanford University, Palo Alto, California.'}, {'ForeName': 'Bruriah', 'Initials': 'B', 'LastName': 'Horowitz', 'Affiliation': 'Department of Medical Social Sciences, Northwestern University Feinberg School of Medicine, Chicago, Illinois.'}, {'ForeName': 'Carly', 'Initials': 'C', 'LastName': 'Maletich', 'Affiliation': 'Department of Medical Social Sciences, Northwestern University Feinberg School of Medicine, Chicago, Illinois.'}, {'ForeName': 'Evelyn', 'Initials': 'E', 'LastName': 'Cordero', 'Affiliation': ''}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Salsman', 'Affiliation': 'Department of Social Sciences and Health Policy, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Smith', 'Affiliation': 'Department of Medical Social Sciences, Northwestern University Feinberg School of Medicine, Chicago, Illinois.'}, {'ForeName': 'Stacy', 'Initials': 'S', 'LastName': 'Sanford', 'Affiliation': 'Department of Medical Social Sciences, Northwestern University Feinberg School of Medicine, Chicago, Illinois.'}]",Psycho-oncology,['10.1002/pon.5355'] 1401,32089006,Triglyceride concentrations and non-high-density lipoprotein cholesterol goal attainment in the ODYSSEY phase 3 trials with alirocumab.,"AIMS Guidelines recommend targeting non-high-density lipoprotein cholesterol to reduce cardiovascular risk. We assessed the impact of baseline triglycerides on non-high-density lipoprotein cholesterol goal attainment in 10 phase 3 trials with alirocumab versus control ( n  = 4983). METHODS Trials were grouped into four pools based on alirocumab dose (75-150 mg every 2 weeks), control (placebo/ezetimibe) and statin use. Baseline triglyceride quintiles were built within each pool. Non-high-density lipoprotein cholesterol goal attainment (very high risk: <100 mg/dl; moderate/high risk: <130 mg/dl), low-density lipoprotein cholesterol goal attainment (very high risk: <70 mg/dl; moderate/high risk: <100 mg/dl) and changes from baseline in lipid parameters were assessed at Week 24 among baseline triglyceride quintiles. RESULTS Higher baseline triglycerides were associated with a worse cardiovascular risk profile. Low-density lipoprotein cholesterol and non-high-density lipoprotein cholesterol increased with higher triglycerides, but the magnitude in non-high-density lipoprotein cholesterol was three- to four-fold higher compared with the increase in low-density lipoprotein cholesterol. Non-high-density lipoprotein cholesterol and low-density lipoprotein cholesterol percentage reductions from baseline with alirocumab were similar regardless of baseline triglycerides. A greater proportion of alirocumab-treated patients attained non-high-density lipoprotein cholesterol and low-density lipoprotein cholesterol goals compared with placebo or ezetimibe. Unlike low-density lipoprotein cholesterol goal attainment, non-high-density lipoprotein cholesterol goal attainment significantly declined with increasing baseline triglycerides ( p  < 0.05 for trend tests). A single standard deviation increase in baseline log(triglycerides) was significantly associated with lower odds ratios of attaining non-high-density lipoprotein cholesterol goals in the different pools and treatment (alirocumab/placebo/ezetimibe) groups, unlike low-density lipoprotein cholesterol goal attainment. CONCLUSION Individuals with increased triglycerides have higher non-high-density lipoprotein cholesterol levels and lower rates of non-high-density lipoprotein cholesterol goal attainment (unlike low-density lipoprotein cholesterol goal attainment). Alirocumab improves non-high-density lipoprotein cholesterol goal attainment in this population. These results highlight the impact of triglycerides on non-high-density lipoprotein cholesterol and the need for novel therapies targeting triglyceride-related pathways.",2020,"Unlike low-density lipoprotein cholesterol goal attainment, non-high-density lipoprotein cholesterol goal attainment significantly declined with increasing baseline triglycerides ( p  < 0.05 for trend tests).",['non-high-density lipoprotein cholesterol goal attainment in 10 phase 3 trials with alirocumab versus control ( n \u2009=\u20094983'],"['placebo/ezetimibe', 'placebo or ezetimibe', 'control (placebo/ezetimibe) and statin use', 'Alirocumab']","['Unlike low-density lipoprotein cholesterol goal attainment, non-high-density lipoprotein cholesterol goal attainment', 'Low-density lipoprotein cholesterol and non-high-density lipoprotein cholesterol', 'density lipoprotein cholesterol', 'Baseline triglyceride quintiles', 'baseline log(triglycerides', 'Triglyceride concentrations and non-high-density lipoprotein cholesterol goal attainment', 'non-high-density lipoprotein cholesterol goal attainment', 'low-density lipoprotein cholesterol. Non-high-density lipoprotein cholesterol and low-density lipoprotein cholesterol percentage reductions', 'cardiovascular risk profile', 'low-density lipoprotein cholesterol goal attainment']","[{'cui': 'C0729627', 'cui_str': 'Non-HDL cholesterol'}, {'cui': 'C0018017', 'cui_str': 'Goals'}, {'cui': 'C0439561', 'cui_str': 'Phase 3 (qualifier value)'}, {'cui': 'C3491162', 'cui_str': 'alirocumab'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1142985', 'cui_str': 'ezetimibe'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0360714', 'cui_str': 'Statins'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C3491162', 'cui_str': 'alirocumab'}]","[{'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0018017', 'cui_str': 'Goals'}, {'cui': 'C0729627', 'cui_str': 'Non-HDL cholesterol'}, {'cui': 'C0178587', 'cui_str': 'Mass to volume ratio'}, {'cui': 'C0065055', 'cui_str': 'lipoprotein cholesterol'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}]",,0.416905,"Unlike low-density lipoprotein cholesterol goal attainment, non-high-density lipoprotein cholesterol goal attainment significantly declined with increasing baseline triglycerides ( p  < 0.05 for trend tests).","[{'ForeName': 'Antonio J', 'Initials': 'AJ', 'LastName': 'Vallejo-Vaz', 'Affiliation': 'Imperial Centre for Cardiovascular Disease Prevention, Imperial College, UK.'}, {'ForeName': 'Lawrence A', 'Initials': 'LA', 'LastName': 'Leiter', 'Affiliation': 'Li Ka Shing Knowledge Institute, University of Toronto, Canada.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Del Prato', 'Affiliation': 'Department of Clinical and Experimental Medicine, University of Pisa, Italy.'}, {'ForeName': 'Marja-Riitta', 'Initials': 'MR', 'LastName': 'Taskinen', 'Affiliation': 'Cardiovascular Research Unit, University of Helsinki, Finland.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Müller-Wieland', 'Affiliation': 'Department of Internal Medicine I, University Hospital Aachen, German.'}, {'ForeName': 'Maja', 'Initials': 'M', 'LastName': 'Bujas-Bobanovic', 'Affiliation': 'Sanofi, Paris, France.'}, {'ForeName': 'Alexia', 'Initials': 'A', 'LastName': 'Letierce', 'Affiliation': 'Sanofi, Chilly-Mazarin, France.'}, {'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'Mandel', 'Affiliation': 'Sanofi, Chilly-Mazarin, France.'}, {'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Samuel', 'Affiliation': 'Regeneron Pharmaceuticals, Inc., USA.'}, {'ForeName': 'Kausik K', 'Initials': 'KK', 'LastName': 'Ray', 'Affiliation': 'Imperial Centre for Cardiovascular Disease Prevention, Imperial College, UK.'}]",European journal of preventive cardiology,['10.1177/2047487320905185'] 1402,24064461,Modulation of motor cortex excitability in obsessive-compulsive disorder: an exploratory study on the relations of neurophysiology measures with clinical outcome.,"Low-frequency repetitive transcranial magnetic stimulation (rTMS) to supplementary motor area (SMA) showed clinical benefit in obsessive-compulsive disorder (OCD). Here we tested whether clinical improvement was associated with enhanced cortical inhibition as measured by single and paired-pulse TMS variables. In 18 OCD patients receiving 4 weeks of either active or sham rTMS in a double-blind randomized trial, we assessed bilateral resting and active motor thresholds (RMT and AMT), cortical silent period (CSP), short-interval intracortical inhibition (SICI) and intracortical facilitation (ICF). We tested correlations between changes in Yale-Brown Obsessive Compulsive Scale-Self-report (Y-BOCS-SR), Clinical Global Impression-Severity subscale (CGI-S) and cortical excitability measures. Active rTMS increased right hemisphere RMT whose change correlated with Y-BOCS-SR improvement. Baseline RMT hemispheric asymmetry, defined as the difference between left and right hemispheres RMT, and its normalization after active rTMS correlated with Y-BOCS-SR and CGI-S improvements. Active rTMS also increased right hemisphere SICI whose change correlated with Y-BOCS-SR and CGI-S at week 4, and with normalization of baseline RMT hemispheric asymmetry. Treatment-induced changes in cortical excitability measures are consistent with an inhibitory action of SMA rTMS on dysfunctional motor circuits in OCD. Correlations of neurophysiology measures with therapeutic outcome are supportive of the role of SMA in the modulation of OCD symptoms.",2013,Treatment-induced changes in cortical excitability measures are consistent with an inhibitory action of SMA rTMS on dysfunctional motor circuits in OCD.,"['obsessive-compulsive disorder', '18 OCD patients receiving 4 weeks of either']","['Low-frequency repetitive transcranial magnetic stimulation (rTMS) to supplementary motor area (SMA', 'active or sham rTMS', 'Active rTMS']","['enhanced cortical inhibition', 'bilateral resting and active motor thresholds (RMT and AMT), cortical silent period (CSP), short-interval intracortical inhibition (SICI) and intracortical facilitation (ICF', 'Yale-Brown Obsessive Compulsive Scale-Self-report (Y-BOCS-SR), Clinical Global Impression-Severity subscale (CGI-S) and cortical excitability measures', 'right hemisphere RMT', 'cortical excitability measures', 'Baseline RMT hemispheric asymmetry', 'right hemisphere SICI']","[{'cui': 'C0028768', 'cui_str': 'Anankastic Personality'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C0205213', 'cui_str': 'Low frequency (qualifier value)'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C3496174', 'cui_str': 'Supplementary Motor Area'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}]","[{'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0449864', 'cui_str': 'Threshold (property) (qualifier value)'}, {'cui': 'C0443304', 'cui_str': 'Silent (qualifier value)'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0234112', 'cui_str': 'Facilitation, function (observable entity)'}, {'cui': 'C0444966', 'cui_str': 'ICF'}, {'cui': 'C0678579', 'cui_str': 'Brown'}, {'cui': 'C0222045'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C4277734', 'cui_str': 'Cortical Excitability'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0205090', 'cui_str': 'Right (qualifier value)'}, {'cui': 'C0205139', 'cui_str': 'Hemispheric (qualifier value)'}, {'cui': 'C0332514', 'cui_str': 'Asymmetry (qualifier value)'}]",18.0,0.0975713,Treatment-induced changes in cortical excitability measures are consistent with an inhibitory action of SMA rTMS on dysfunctional motor circuits in OCD.,"[{'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Mantovani', 'Affiliation': 'Division of Experimental Therapeutics, Department of Psychiatry, Columbia University/New York State Psychiatric Institute, New York, NY, USA; Division of Psychiatry, Department of Neuroscience, Siena University, Siena, Italy. Electronic address: am2518@columbia.edu.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Rossi', 'Affiliation': ''}, {'ForeName': 'Bruce D', 'Initials': 'BD', 'LastName': 'Bassi', 'Affiliation': ''}, {'ForeName': 'Helen B', 'Initials': 'HB', 'LastName': 'Simpson', 'Affiliation': ''}, {'ForeName': 'Brian A', 'Initials': 'BA', 'LastName': 'Fallon', 'Affiliation': ''}, {'ForeName': 'Sarah H', 'Initials': 'SH', 'LastName': 'Lisanby', 'Affiliation': ''}]",Psychiatry research,['10.1016/j.psychres.2013.08.054'] 1403,31340089,Roxadustat for Anemia in Patients with Kidney Disease Not Receiving Dialysis.,"BACKGROUND Roxadustat (FG-4592) is an oral inhibitor of hypoxia-inducible factor (HIF) prolyl hydroxylase that stimulates erythropoiesis and regulates iron metabolism. In phase 2 studies involving patients with chronic kidney disease, roxadustat increased levels of endogenous erythropoietin to within or near the physiologic range, along with increasing hemoglobin levels and improving iron homeostasis. Additional data are needed regarding the efficacy and safety of roxadustat for the treatment of anemia in patients with chronic kidney disease who are not undergoing dialysis. METHODS In this phase 3 trial conducted at 29 sites in China, we randomly assigned 154 patients with chronic kidney disease in a 2:1 ratio to receive roxadustat or placebo three times a week for 8 weeks in a double-blind manner. All the patients had a hemoglobin level of 7.0 to 10.0 g per deciliter at baseline. The randomized phase of the trial was followed by an 18-week open-label period in which all the patients received roxadustat; parenteral iron was withheld. The primary end point was the mean change from baseline in the hemoglobin level, averaged over weeks 7 through 9. RESULTS During the primary-analysis period, the mean (±SD) change from baseline in the hemoglobin level was an increase of 1.9±1.2 g per deciliter in the roxadustat group and a decrease of 0.4±0.8 g per deciliter in the placebo group (P<0.001). The mean reduction from baseline in the hepcidin level (associated with greater iron availability) was 56.14±63.40 ng per milliliter in the roxadustat group and 15.10±48.06 ng per milliliter in the placebo group. The reduction from baseline in the total cholesterol level was 40.6 mg per deciliter in the roxadustat group and 7.7 mg per deciliter in the placebo group. Hyperkalemia and metabolic acidosis occurred more frequently in the roxadustat group than in the placebo group. The efficacy of roxadustat in hemoglobin correction and maintenance was maintained during the 18-week open-label period. CONCLUSIONS In Chinese patients with chronic kidney disease who were not undergoing dialysis, those in the roxadustat group had a higher mean hemoglobin level than those in the placebo group after 8 weeks. During the 18-week open-label phase of the trial, roxadustat was associated with continued efficacy. (Funded by FibroGen and FibroGen [China] Medical Technology Development; ClinicalTrials.gov number, NCT02652819.).",2019,"The efficacy of roxadustat in hemoglobin correction and maintenance was maintained during the 18-week open-label period. ","['patients with chronic kidney disease who are not undergoing dialysis', 'Patients with Kidney Disease', 'patients with chronic kidney disease', '29 sites in China, we randomly assigned 154 patients with chronic kidney disease in a 2:1 ratio to receive', 'Chinese patients with chronic kidney disease']","['FibroGen and FibroGen', 'placebo', 'Roxadustat (FG-4592', 'roxadustat or placebo']","['total cholesterol level', 'levels of endogenous erythropoietin', 'hemoglobin level', 'mean hemoglobin level', 'Hyperkalemia and metabolic acidosis', 'hemoglobin levels and improving iron homeostasis', 'mean change from baseline in the hemoglobin level']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1561643', 'cui_str': 'Chronic Kidney Diseases'}, {'cui': 'C4551529', 'cui_str': 'Renal Dialysis'}, {'cui': 'C0022658', 'cui_str': 'Kidney Diseases'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4310578'}, {'cui': 'C3713379', 'cui_str': 'FG-4592'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0428466', 'cui_str': 'Finding of cholesterol level (finding)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205227', 'cui_str': 'Endogenous (qualifier value)'}, {'cui': 'C0014822', 'cui_str': 'Erythropoietin'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0020461', 'cui_str': 'Hyperpotassemia'}, {'cui': 'C0220981', 'cui_str': 'Metabolic acidosis (disorder)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0337439', 'cui_str': 'Iron measurement (procedure)'}, {'cui': 'C0019868', 'cui_str': 'Autoregulation'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]",154.0,0.14697,"The efficacy of roxadustat in hemoglobin correction and maintenance was maintained during the 18-week open-label period. ","[{'ForeName': 'Nan', 'Initials': 'N', 'LastName': 'Chen', 'Affiliation': ""From the Department of Nephrology, Institute of Nephrology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine (N.C.), and the Division of Nephrology, Huashan Hospital Fudan University (C.H.), Shanghai, the Department of Nephrology, People's Hospital of Guangxi Zhuang Autonomous Region (X.P.), and the Department of Nephrology, First Affiliated Hospital of Guangxi Medical University (Y.L.), Nanning, the First Affiliated Hospital of Dalian Medical University, Dalian (H.L.), the Department of Nephrology, First Affiliated Hospital of Xi'an Jiaotong University, Xi'an (A.Y.), the Department of Nephrology, Second Hospital of Anhui Medical University, Hefei (L.H.), West China Hospital Sichuan University, Chengdu (Y.T.), the Division of Nephrology, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences (X.L.), and the Renal Division, Nanfang Hospital, Southern Medical University, National Clinical Research Center for Kidney Disease, State Key Laboratory of Organ Failure Research (Z.L.), Guangzhou, the Department of Nephrology, First Affiliated Hospital (Jiangsu Province Hospital), Nanjing Medical University (C.X.), and the Institute of Nephrology, Zhong Da Hospital, Southeast University School of Medicine (B.-C.L.), Nanjing, First Affiliated Hospital of Zhejiang University, Hangzhou (J.C.), First Affiliated Hospital of Nanchang University, Nanchang (L.L.), and the Department of Nephrology, Peking University People's Hospital, Beijing (L.Z.) - all in China; and FibroGen, San Francisco (R.L., C.W., C.L., T.N., L.S., K.-H.P.Y.).""}, {'ForeName': 'Chuanming', 'Initials': 'C', 'LastName': 'Hao', 'Affiliation': ""From the Department of Nephrology, Institute of Nephrology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine (N.C.), and the Division of Nephrology, Huashan Hospital Fudan University (C.H.), Shanghai, the Department of Nephrology, People's Hospital of Guangxi Zhuang Autonomous Region (X.P.), and the Department of Nephrology, First Affiliated Hospital of Guangxi Medical University (Y.L.), Nanning, the First Affiliated Hospital of Dalian Medical University, Dalian (H.L.), the Department of Nephrology, First Affiliated Hospital of Xi'an Jiaotong University, Xi'an (A.Y.), the Department of Nephrology, Second Hospital of Anhui Medical University, Hefei (L.H.), West China Hospital Sichuan University, Chengdu (Y.T.), the Division of Nephrology, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences (X.L.), and the Renal Division, Nanfang Hospital, Southern Medical University, National Clinical Research Center for Kidney Disease, State Key Laboratory of Organ Failure Research (Z.L.), Guangzhou, the Department of Nephrology, First Affiliated Hospital (Jiangsu Province Hospital), Nanjing Medical University (C.X.), and the Institute of Nephrology, Zhong Da Hospital, Southeast University School of Medicine (B.-C.L.), Nanjing, First Affiliated Hospital of Zhejiang University, Hangzhou (J.C.), First Affiliated Hospital of Nanchang University, Nanchang (L.L.), and the Department of Nephrology, Peking University People's Hospital, Beijing (L.Z.) - all in China; and FibroGen, San Francisco (R.L., C.W., C.L., T.N., L.S., K.-H.P.Y.).""}, {'ForeName': 'Xiaomei', 'Initials': 'X', 'LastName': 'Peng', 'Affiliation': ""From the Department of Nephrology, Institute of Nephrology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine (N.C.), and the Division of Nephrology, Huashan Hospital Fudan University (C.H.), Shanghai, the Department of Nephrology, People's Hospital of Guangxi Zhuang Autonomous Region (X.P.), and the Department of Nephrology, First Affiliated Hospital of Guangxi Medical University (Y.L.), Nanning, the First Affiliated Hospital of Dalian Medical University, Dalian (H.L.), the Department of Nephrology, First Affiliated Hospital of Xi'an Jiaotong University, Xi'an (A.Y.), the Department of Nephrology, Second Hospital of Anhui Medical University, Hefei (L.H.), West China Hospital Sichuan University, Chengdu (Y.T.), the Division of Nephrology, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences (X.L.), and the Renal Division, Nanfang Hospital, Southern Medical University, National Clinical Research Center for Kidney Disease, State Key Laboratory of Organ Failure Research (Z.L.), Guangzhou, the Department of Nephrology, First Affiliated Hospital (Jiangsu Province Hospital), Nanjing Medical University (C.X.), and the Institute of Nephrology, Zhong Da Hospital, Southeast University School of Medicine (B.-C.L.), Nanjing, First Affiliated Hospital of Zhejiang University, Hangzhou (J.C.), First Affiliated Hospital of Nanchang University, Nanchang (L.L.), and the Department of Nephrology, Peking University People's Hospital, Beijing (L.Z.) - all in China; and FibroGen, San Francisco (R.L., C.W., C.L., T.N., L.S., K.-H.P.Y.).""}, {'ForeName': 'Hongli', 'Initials': 'H', 'LastName': 'Lin', 'Affiliation': ""From the Department of Nephrology, Institute of Nephrology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine (N.C.), and the Division of Nephrology, Huashan Hospital Fudan University (C.H.), Shanghai, the Department of Nephrology, People's Hospital of Guangxi Zhuang Autonomous Region (X.P.), and the Department of Nephrology, First Affiliated Hospital of Guangxi Medical University (Y.L.), Nanning, the First Affiliated Hospital of Dalian Medical University, Dalian (H.L.), the Department of Nephrology, First Affiliated Hospital of Xi'an Jiaotong University, Xi'an (A.Y.), the Department of Nephrology, Second Hospital of Anhui Medical University, Hefei (L.H.), West China Hospital Sichuan University, Chengdu (Y.T.), the Division of Nephrology, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences (X.L.), and the Renal Division, Nanfang Hospital, Southern Medical University, National Clinical Research Center for Kidney Disease, State Key Laboratory of Organ Failure Research (Z.L.), Guangzhou, the Department of Nephrology, First Affiliated Hospital (Jiangsu Province Hospital), Nanjing Medical University (C.X.), and the Institute of Nephrology, Zhong Da Hospital, Southeast University School of Medicine (B.-C.L.), Nanjing, First Affiliated Hospital of Zhejiang University, Hangzhou (J.C.), First Affiliated Hospital of Nanchang University, Nanchang (L.L.), and the Department of Nephrology, Peking University People's Hospital, Beijing (L.Z.) - all in China; and FibroGen, San Francisco (R.L., C.W., C.L., T.N., L.S., K.-H.P.Y.).""}, {'ForeName': 'Aiping', 'Initials': 'A', 'LastName': 'Yin', 'Affiliation': ""From the Department of Nephrology, Institute of Nephrology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine (N.C.), and the Division of Nephrology, Huashan Hospital Fudan University (C.H.), Shanghai, the Department of Nephrology, People's Hospital of Guangxi Zhuang Autonomous Region (X.P.), and the Department of Nephrology, First Affiliated Hospital of Guangxi Medical University (Y.L.), Nanning, the First Affiliated Hospital of Dalian Medical University, Dalian (H.L.), the Department of Nephrology, First Affiliated Hospital of Xi'an Jiaotong University, Xi'an (A.Y.), the Department of Nephrology, Second Hospital of Anhui Medical University, Hefei (L.H.), West China Hospital Sichuan University, Chengdu (Y.T.), the Division of Nephrology, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences (X.L.), and the Renal Division, Nanfang Hospital, Southern Medical University, National Clinical Research Center for Kidney Disease, State Key Laboratory of Organ Failure Research (Z.L.), Guangzhou, the Department of Nephrology, First Affiliated Hospital (Jiangsu Province Hospital), Nanjing Medical University (C.X.), and the Institute of Nephrology, Zhong Da Hospital, Southeast University School of Medicine (B.-C.L.), Nanjing, First Affiliated Hospital of Zhejiang University, Hangzhou (J.C.), First Affiliated Hospital of Nanchang University, Nanchang (L.L.), and the Department of Nephrology, Peking University People's Hospital, Beijing (L.Z.) - all in China; and FibroGen, San Francisco (R.L., C.W., C.L., T.N., L.S., K.-H.P.Y.).""}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Hao', 'Affiliation': ""From the Department of Nephrology, Institute of Nephrology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine (N.C.), and the Division of Nephrology, Huashan Hospital Fudan University (C.H.), Shanghai, the Department of Nephrology, People's Hospital of Guangxi Zhuang Autonomous Region (X.P.), and the Department of Nephrology, First Affiliated Hospital of Guangxi Medical University (Y.L.), Nanning, the First Affiliated Hospital of Dalian Medical University, Dalian (H.L.), the Department of Nephrology, First Affiliated Hospital of Xi'an Jiaotong University, Xi'an (A.Y.), the Department of Nephrology, Second Hospital of Anhui Medical University, Hefei (L.H.), West China Hospital Sichuan University, Chengdu (Y.T.), the Division of Nephrology, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences (X.L.), and the Renal Division, Nanfang Hospital, Southern Medical University, National Clinical Research Center for Kidney Disease, State Key Laboratory of Organ Failure Research (Z.L.), Guangzhou, the Department of Nephrology, First Affiliated Hospital (Jiangsu Province Hospital), Nanjing Medical University (C.X.), and the Institute of Nephrology, Zhong Da Hospital, Southeast University School of Medicine (B.-C.L.), Nanjing, First Affiliated Hospital of Zhejiang University, Hangzhou (J.C.), First Affiliated Hospital of Nanchang University, Nanchang (L.L.), and the Department of Nephrology, Peking University People's Hospital, Beijing (L.Z.) - all in China; and FibroGen, San Francisco (R.L., C.W., C.L., T.N., L.S., K.-H.P.Y.).""}, {'ForeName': 'Ye', 'Initials': 'Y', 'LastName': 'Tao', 'Affiliation': ""From the Department of Nephrology, Institute of Nephrology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine (N.C.), and the Division of Nephrology, Huashan Hospital Fudan University (C.H.), Shanghai, the Department of Nephrology, People's Hospital of Guangxi Zhuang Autonomous Region (X.P.), and the Department of Nephrology, First Affiliated Hospital of Guangxi Medical University (Y.L.), Nanning, the First Affiliated Hospital of Dalian Medical University, Dalian (H.L.), the Department of Nephrology, First Affiliated Hospital of Xi'an Jiaotong University, Xi'an (A.Y.), the Department of Nephrology, Second Hospital of Anhui Medical University, Hefei (L.H.), West China Hospital Sichuan University, Chengdu (Y.T.), the Division of Nephrology, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences (X.L.), and the Renal Division, Nanfang Hospital, Southern Medical University, National Clinical Research Center for Kidney Disease, State Key Laboratory of Organ Failure Research (Z.L.), Guangzhou, the Department of Nephrology, First Affiliated Hospital (Jiangsu Province Hospital), Nanjing Medical University (C.X.), and the Institute of Nephrology, Zhong Da Hospital, Southeast University School of Medicine (B.-C.L.), Nanjing, First Affiliated Hospital of Zhejiang University, Hangzhou (J.C.), First Affiliated Hospital of Nanchang University, Nanchang (L.L.), and the Department of Nephrology, Peking University People's Hospital, Beijing (L.Z.) - all in China; and FibroGen, San Francisco (R.L., C.W., C.L., T.N., L.S., K.-H.P.Y.).""}, {'ForeName': 'Xinling', 'Initials': 'X', 'LastName': 'Liang', 'Affiliation': ""From the Department of Nephrology, Institute of Nephrology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine (N.C.), and the Division of Nephrology, Huashan Hospital Fudan University (C.H.), Shanghai, the Department of Nephrology, People's Hospital of Guangxi Zhuang Autonomous Region (X.P.), and the Department of Nephrology, First Affiliated Hospital of Guangxi Medical University (Y.L.), Nanning, the First Affiliated Hospital of Dalian Medical University, Dalian (H.L.), the Department of Nephrology, First Affiliated Hospital of Xi'an Jiaotong University, Xi'an (A.Y.), the Department of Nephrology, Second Hospital of Anhui Medical University, Hefei (L.H.), West China Hospital Sichuan University, Chengdu (Y.T.), the Division of Nephrology, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences (X.L.), and the Renal Division, Nanfang Hospital, Southern Medical University, National Clinical Research Center for Kidney Disease, State Key Laboratory of Organ Failure Research (Z.L.), Guangzhou, the Department of Nephrology, First Affiliated Hospital (Jiangsu Province Hospital), Nanjing Medical University (C.X.), and the Institute of Nephrology, Zhong Da Hospital, Southeast University School of Medicine (B.-C.L.), Nanjing, First Affiliated Hospital of Zhejiang University, Hangzhou (J.C.), First Affiliated Hospital of Nanchang University, Nanchang (L.L.), and the Department of Nephrology, Peking University People's Hospital, Beijing (L.Z.) - all in China; and FibroGen, San Francisco (R.L., C.W., C.L., T.N., L.S., K.-H.P.Y.).""}, {'ForeName': 'Zhengrong', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': ""From the Department of Nephrology, Institute of Nephrology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine (N.C.), and the Division of Nephrology, Huashan Hospital Fudan University (C.H.), Shanghai, the Department of Nephrology, People's Hospital of Guangxi Zhuang Autonomous Region (X.P.), and the Department of Nephrology, First Affiliated Hospital of Guangxi Medical University (Y.L.), Nanning, the First Affiliated Hospital of Dalian Medical University, Dalian (H.L.), the Department of Nephrology, First Affiliated Hospital of Xi'an Jiaotong University, Xi'an (A.Y.), the Department of Nephrology, Second Hospital of Anhui Medical University, Hefei (L.H.), West China Hospital Sichuan University, Chengdu (Y.T.), the Division of Nephrology, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences (X.L.), and the Renal Division, Nanfang Hospital, Southern Medical University, National Clinical Research Center for Kidney Disease, State Key Laboratory of Organ Failure Research (Z.L.), Guangzhou, the Department of Nephrology, First Affiliated Hospital (Jiangsu Province Hospital), Nanjing Medical University (C.X.), and the Institute of Nephrology, Zhong Da Hospital, Southeast University School of Medicine (B.-C.L.), Nanjing, First Affiliated Hospital of Zhejiang University, Hangzhou (J.C.), First Affiliated Hospital of Nanchang University, Nanchang (L.L.), and the Department of Nephrology, Peking University People's Hospital, Beijing (L.Z.) - all in China; and FibroGen, San Francisco (R.L., C.W., C.L., T.N., L.S., K.-H.P.Y.).""}, {'ForeName': 'Changying', 'Initials': 'C', 'LastName': 'Xing', 'Affiliation': ""From the Department of Nephrology, Institute of Nephrology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine (N.C.), and the Division of Nephrology, Huashan Hospital Fudan University (C.H.), Shanghai, the Department of Nephrology, People's Hospital of Guangxi Zhuang Autonomous Region (X.P.), and the Department of Nephrology, First Affiliated Hospital of Guangxi Medical University (Y.L.), Nanning, the First Affiliated Hospital of Dalian Medical University, Dalian (H.L.), the Department of Nephrology, First Affiliated Hospital of Xi'an Jiaotong University, Xi'an (A.Y.), the Department of Nephrology, Second Hospital of Anhui Medical University, Hefei (L.H.), West China Hospital Sichuan University, Chengdu (Y.T.), the Division of Nephrology, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences (X.L.), and the Renal Division, Nanfang Hospital, Southern Medical University, National Clinical Research Center for Kidney Disease, State Key Laboratory of Organ Failure Research (Z.L.), Guangzhou, the Department of Nephrology, First Affiliated Hospital (Jiangsu Province Hospital), Nanjing Medical University (C.X.), and the Institute of Nephrology, Zhong Da Hospital, Southeast University School of Medicine (B.-C.L.), Nanjing, First Affiliated Hospital of Zhejiang University, Hangzhou (J.C.), First Affiliated Hospital of Nanchang University, Nanchang (L.L.), and the Department of Nephrology, Peking University People's Hospital, Beijing (L.Z.) - all in China; and FibroGen, San Francisco (R.L., C.W., C.L., T.N., L.S., K.-H.P.Y.).""}, {'ForeName': 'Jianghua', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': ""From the Department of Nephrology, Institute of Nephrology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine (N.C.), and the Division of Nephrology, Huashan Hospital Fudan University (C.H.), Shanghai, the Department of Nephrology, People's Hospital of Guangxi Zhuang Autonomous Region (X.P.), and the Department of Nephrology, First Affiliated Hospital of Guangxi Medical University (Y.L.), Nanning, the First Affiliated Hospital of Dalian Medical University, Dalian (H.L.), the Department of Nephrology, First Affiliated Hospital of Xi'an Jiaotong University, Xi'an (A.Y.), the Department of Nephrology, Second Hospital of Anhui Medical University, Hefei (L.H.), West China Hospital Sichuan University, Chengdu (Y.T.), the Division of Nephrology, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences (X.L.), and the Renal Division, Nanfang Hospital, Southern Medical University, National Clinical Research Center for Kidney Disease, State Key Laboratory of Organ Failure Research (Z.L.), Guangzhou, the Department of Nephrology, First Affiliated Hospital (Jiangsu Province Hospital), Nanjing Medical University (C.X.), and the Institute of Nephrology, Zhong Da Hospital, Southeast University School of Medicine (B.-C.L.), Nanjing, First Affiliated Hospital of Zhejiang University, Hangzhou (J.C.), First Affiliated Hospital of Nanchang University, Nanchang (L.L.), and the Department of Nephrology, Peking University People's Hospital, Beijing (L.Z.) - all in China; and FibroGen, San Francisco (R.L., C.W., C.L., T.N., L.S., K.-H.P.Y.).""}, {'ForeName': 'Laimin', 'Initials': 'L', 'LastName': 'Luo', 'Affiliation': ""From the Department of Nephrology, Institute of Nephrology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine (N.C.), and the Division of Nephrology, Huashan Hospital Fudan University (C.H.), Shanghai, the Department of Nephrology, People's Hospital of Guangxi Zhuang Autonomous Region (X.P.), and the Department of Nephrology, First Affiliated Hospital of Guangxi Medical University (Y.L.), Nanning, the First Affiliated Hospital of Dalian Medical University, Dalian (H.L.), the Department of Nephrology, First Affiliated Hospital of Xi'an Jiaotong University, Xi'an (A.Y.), the Department of Nephrology, Second Hospital of Anhui Medical University, Hefei (L.H.), West China Hospital Sichuan University, Chengdu (Y.T.), the Division of Nephrology, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences (X.L.), and the Renal Division, Nanfang Hospital, Southern Medical University, National Clinical Research Center for Kidney Disease, State Key Laboratory of Organ Failure Research (Z.L.), Guangzhou, the Department of Nephrology, First Affiliated Hospital (Jiangsu Province Hospital), Nanjing Medical University (C.X.), and the Institute of Nephrology, Zhong Da Hospital, Southeast University School of Medicine (B.-C.L.), Nanjing, First Affiliated Hospital of Zhejiang University, Hangzhou (J.C.), First Affiliated Hospital of Nanchang University, Nanchang (L.L.), and the Department of Nephrology, Peking University People's Hospital, Beijing (L.Z.) - all in China; and FibroGen, San Francisco (R.L., C.W., C.L., T.N., L.S., K.-H.P.Y.).""}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Zuo', 'Affiliation': ""From the Department of Nephrology, Institute of Nephrology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine (N.C.), and the Division of Nephrology, Huashan Hospital Fudan University (C.H.), Shanghai, the Department of Nephrology, People's Hospital of Guangxi Zhuang Autonomous Region (X.P.), and the Department of Nephrology, First Affiliated Hospital of Guangxi Medical University (Y.L.), Nanning, the First Affiliated Hospital of Dalian Medical University, Dalian (H.L.), the Department of Nephrology, First Affiliated Hospital of Xi'an Jiaotong University, Xi'an (A.Y.), the Department of Nephrology, Second Hospital of Anhui Medical University, Hefei (L.H.), West China Hospital Sichuan University, Chengdu (Y.T.), the Division of Nephrology, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences (X.L.), and the Renal Division, Nanfang Hospital, Southern Medical University, National Clinical Research Center for Kidney Disease, State Key Laboratory of Organ Failure Research (Z.L.), Guangzhou, the Department of Nephrology, First Affiliated Hospital (Jiangsu Province Hospital), Nanjing Medical University (C.X.), and the Institute of Nephrology, Zhong Da Hospital, Southeast University School of Medicine (B.-C.L.), Nanjing, First Affiliated Hospital of Zhejiang University, Hangzhou (J.C.), First Affiliated Hospital of Nanchang University, Nanchang (L.L.), and the Department of Nephrology, Peking University People's Hospital, Beijing (L.Z.) - all in China; and FibroGen, San Francisco (R.L., C.W., C.L., T.N., L.S., K.-H.P.Y.).""}, {'ForeName': 'Yunhua', 'Initials': 'Y', 'LastName': 'Liao', 'Affiliation': ""From the Department of Nephrology, Institute of Nephrology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine (N.C.), and the Division of Nephrology, Huashan Hospital Fudan University (C.H.), Shanghai, the Department of Nephrology, People's Hospital of Guangxi Zhuang Autonomous Region (X.P.), and the Department of Nephrology, First Affiliated Hospital of Guangxi Medical University (Y.L.), Nanning, the First Affiliated Hospital of Dalian Medical University, Dalian (H.L.), the Department of Nephrology, First Affiliated Hospital of Xi'an Jiaotong University, Xi'an (A.Y.), the Department of Nephrology, Second Hospital of Anhui Medical University, Hefei (L.H.), West China Hospital Sichuan University, Chengdu (Y.T.), the Division of Nephrology, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences (X.L.), and the Renal Division, Nanfang Hospital, Southern Medical University, National Clinical Research Center for Kidney Disease, State Key Laboratory of Organ Failure Research (Z.L.), Guangzhou, the Department of Nephrology, First Affiliated Hospital (Jiangsu Province Hospital), Nanjing Medical University (C.X.), and the Institute of Nephrology, Zhong Da Hospital, Southeast University School of Medicine (B.-C.L.), Nanjing, First Affiliated Hospital of Zhejiang University, Hangzhou (J.C.), First Affiliated Hospital of Nanchang University, Nanchang (L.L.), and the Department of Nephrology, Peking University People's Hospital, Beijing (L.Z.) - all in China; and FibroGen, San Francisco (R.L., C.W., C.L., T.N., L.S., K.-H.P.Y.).""}, {'ForeName': 'Bi-Cheng', 'Initials': 'BC', 'LastName': 'Liu', 'Affiliation': ""From the Department of Nephrology, Institute of Nephrology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine (N.C.), and the Division of Nephrology, Huashan Hospital Fudan University (C.H.), Shanghai, the Department of Nephrology, People's Hospital of Guangxi Zhuang Autonomous Region (X.P.), and the Department of Nephrology, First Affiliated Hospital of Guangxi Medical University (Y.L.), Nanning, the First Affiliated Hospital of Dalian Medical University, Dalian (H.L.), the Department of Nephrology, First Affiliated Hospital of Xi'an Jiaotong University, Xi'an (A.Y.), the Department of Nephrology, Second Hospital of Anhui Medical University, Hefei (L.H.), West China Hospital Sichuan University, Chengdu (Y.T.), the Division of Nephrology, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences (X.L.), and the Renal Division, Nanfang Hospital, Southern Medical University, National Clinical Research Center for Kidney Disease, State Key Laboratory of Organ Failure Research (Z.L.), Guangzhou, the Department of Nephrology, First Affiliated Hospital (Jiangsu Province Hospital), Nanjing Medical University (C.X.), and the Institute of Nephrology, Zhong Da Hospital, Southeast University School of Medicine (B.-C.L.), Nanjing, First Affiliated Hospital of Zhejiang University, Hangzhou (J.C.), First Affiliated Hospital of Nanchang University, Nanchang (L.L.), and the Department of Nephrology, Peking University People's Hospital, Beijing (L.Z.) - all in China; and FibroGen, San Francisco (R.L., C.W., C.L., T.N., L.S., K.-H.P.Y.).""}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Leong', 'Affiliation': ""From the Department of Nephrology, Institute of Nephrology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine (N.C.), and the Division of Nephrology, Huashan Hospital Fudan University (C.H.), Shanghai, the Department of Nephrology, People's Hospital of Guangxi Zhuang Autonomous Region (X.P.), and the Department of Nephrology, First Affiliated Hospital of Guangxi Medical University (Y.L.), Nanning, the First Affiliated Hospital of Dalian Medical University, Dalian (H.L.), the Department of Nephrology, First Affiliated Hospital of Xi'an Jiaotong University, Xi'an (A.Y.), the Department of Nephrology, Second Hospital of Anhui Medical University, Hefei (L.H.), West China Hospital Sichuan University, Chengdu (Y.T.), the Division of Nephrology, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences (X.L.), and the Renal Division, Nanfang Hospital, Southern Medical University, National Clinical Research Center for Kidney Disease, State Key Laboratory of Organ Failure Research (Z.L.), Guangzhou, the Department of Nephrology, First Affiliated Hospital (Jiangsu Province Hospital), Nanjing Medical University (C.X.), and the Institute of Nephrology, Zhong Da Hospital, Southeast University School of Medicine (B.-C.L.), Nanjing, First Affiliated Hospital of Zhejiang University, Hangzhou (J.C.), First Affiliated Hospital of Nanchang University, Nanchang (L.L.), and the Department of Nephrology, Peking University People's Hospital, Beijing (L.Z.) - all in China; and FibroGen, San Francisco (R.L., C.W., C.L., T.N., L.S., K.-H.P.Y.).""}, {'ForeName': 'Chunrong', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': ""From the Department of Nephrology, Institute of Nephrology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine (N.C.), and the Division of Nephrology, Huashan Hospital Fudan University (C.H.), Shanghai, the Department of Nephrology, People's Hospital of Guangxi Zhuang Autonomous Region (X.P.), and the Department of Nephrology, First Affiliated Hospital of Guangxi Medical University (Y.L.), Nanning, the First Affiliated Hospital of Dalian Medical University, Dalian (H.L.), the Department of Nephrology, First Affiliated Hospital of Xi'an Jiaotong University, Xi'an (A.Y.), the Department of Nephrology, Second Hospital of Anhui Medical University, Hefei (L.H.), West China Hospital Sichuan University, Chengdu (Y.T.), the Division of Nephrology, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences (X.L.), and the Renal Division, Nanfang Hospital, Southern Medical University, National Clinical Research Center for Kidney Disease, State Key Laboratory of Organ Failure Research (Z.L.), Guangzhou, the Department of Nephrology, First Affiliated Hospital (Jiangsu Province Hospital), Nanjing Medical University (C.X.), and the Institute of Nephrology, Zhong Da Hospital, Southeast University School of Medicine (B.-C.L.), Nanjing, First Affiliated Hospital of Zhejiang University, Hangzhou (J.C.), First Affiliated Hospital of Nanchang University, Nanchang (L.L.), and the Department of Nephrology, Peking University People's Hospital, Beijing (L.Z.) - all in China; and FibroGen, San Francisco (R.L., C.W., C.L., T.N., L.S., K.-H.P.Y.).""}, {'ForeName': 'Cameron', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': ""From the Department of Nephrology, Institute of Nephrology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine (N.C.), and the Division of Nephrology, Huashan Hospital Fudan University (C.H.), Shanghai, the Department of Nephrology, People's Hospital of Guangxi Zhuang Autonomous Region (X.P.), and the Department of Nephrology, First Affiliated Hospital of Guangxi Medical University (Y.L.), Nanning, the First Affiliated Hospital of Dalian Medical University, Dalian (H.L.), the Department of Nephrology, First Affiliated Hospital of Xi'an Jiaotong University, Xi'an (A.Y.), the Department of Nephrology, Second Hospital of Anhui Medical University, Hefei (L.H.), West China Hospital Sichuan University, Chengdu (Y.T.), the Division of Nephrology, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences (X.L.), and the Renal Division, Nanfang Hospital, Southern Medical University, National Clinical Research Center for Kidney Disease, State Key Laboratory of Organ Failure Research (Z.L.), Guangzhou, the Department of Nephrology, First Affiliated Hospital (Jiangsu Province Hospital), Nanjing Medical University (C.X.), and the Institute of Nephrology, Zhong Da Hospital, Southeast University School of Medicine (B.-C.L.), Nanjing, First Affiliated Hospital of Zhejiang University, Hangzhou (J.C.), First Affiliated Hospital of Nanchang University, Nanchang (L.L.), and the Department of Nephrology, Peking University People's Hospital, Beijing (L.Z.) - all in China; and FibroGen, San Francisco (R.L., C.W., C.L., T.N., L.S., K.-H.P.Y.).""}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Neff', 'Affiliation': ""From the Department of Nephrology, Institute of Nephrology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine (N.C.), and the Division of Nephrology, Huashan Hospital Fudan University (C.H.), Shanghai, the Department of Nephrology, People's Hospital of Guangxi Zhuang Autonomous Region (X.P.), and the Department of Nephrology, First Affiliated Hospital of Guangxi Medical University (Y.L.), Nanning, the First Affiliated Hospital of Dalian Medical University, Dalian (H.L.), the Department of Nephrology, First Affiliated Hospital of Xi'an Jiaotong University, Xi'an (A.Y.), the Department of Nephrology, Second Hospital of Anhui Medical University, Hefei (L.H.), West China Hospital Sichuan University, Chengdu (Y.T.), the Division of Nephrology, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences (X.L.), and the Renal Division, Nanfang Hospital, Southern Medical University, National Clinical Research Center for Kidney Disease, State Key Laboratory of Organ Failure Research (Z.L.), Guangzhou, the Department of Nephrology, First Affiliated Hospital (Jiangsu Province Hospital), Nanjing Medical University (C.X.), and the Institute of Nephrology, Zhong Da Hospital, Southeast University School of Medicine (B.-C.L.), Nanjing, First Affiliated Hospital of Zhejiang University, Hangzhou (J.C.), First Affiliated Hospital of Nanchang University, Nanchang (L.L.), and the Department of Nephrology, Peking University People's Hospital, Beijing (L.Z.) - all in China; and FibroGen, San Francisco (R.L., C.W., C.L., T.N., L.S., K.-H.P.Y.).""}, {'ForeName': 'Lynda', 'Initials': 'L', 'LastName': 'Szczech', 'Affiliation': ""From the Department of Nephrology, Institute of Nephrology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine (N.C.), and the Division of Nephrology, Huashan Hospital Fudan University (C.H.), Shanghai, the Department of Nephrology, People's Hospital of Guangxi Zhuang Autonomous Region (X.P.), and the Department of Nephrology, First Affiliated Hospital of Guangxi Medical University (Y.L.), Nanning, the First Affiliated Hospital of Dalian Medical University, Dalian (H.L.), the Department of Nephrology, First Affiliated Hospital of Xi'an Jiaotong University, Xi'an (A.Y.), the Department of Nephrology, Second Hospital of Anhui Medical University, Hefei (L.H.), West China Hospital Sichuan University, Chengdu (Y.T.), the Division of Nephrology, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences (X.L.), and the Renal Division, Nanfang Hospital, Southern Medical University, National Clinical Research Center for Kidney Disease, State Key Laboratory of Organ Failure Research (Z.L.), Guangzhou, the Department of Nephrology, First Affiliated Hospital (Jiangsu Province Hospital), Nanjing Medical University (C.X.), and the Institute of Nephrology, Zhong Da Hospital, Southeast University School of Medicine (B.-C.L.), Nanjing, First Affiliated Hospital of Zhejiang University, Hangzhou (J.C.), First Affiliated Hospital of Nanchang University, Nanchang (L.L.), and the Department of Nephrology, Peking University People's Hospital, Beijing (L.Z.) - all in China; and FibroGen, San Francisco (R.L., C.W., C.L., T.N., L.S., K.-H.P.Y.).""}, {'ForeName': 'Kin-Hung P', 'Initials': 'KP', 'LastName': 'Yu', 'Affiliation': ""From the Department of Nephrology, Institute of Nephrology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine (N.C.), and the Division of Nephrology, Huashan Hospital Fudan University (C.H.), Shanghai, the Department of Nephrology, People's Hospital of Guangxi Zhuang Autonomous Region (X.P.), and the Department of Nephrology, First Affiliated Hospital of Guangxi Medical University (Y.L.), Nanning, the First Affiliated Hospital of Dalian Medical University, Dalian (H.L.), the Department of Nephrology, First Affiliated Hospital of Xi'an Jiaotong University, Xi'an (A.Y.), the Department of Nephrology, Second Hospital of Anhui Medical University, Hefei (L.H.), West China Hospital Sichuan University, Chengdu (Y.T.), the Division of Nephrology, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences (X.L.), and the Renal Division, Nanfang Hospital, Southern Medical University, National Clinical Research Center for Kidney Disease, State Key Laboratory of Organ Failure Research (Z.L.), Guangzhou, the Department of Nephrology, First Affiliated Hospital (Jiangsu Province Hospital), Nanjing Medical University (C.X.), and the Institute of Nephrology, Zhong Da Hospital, Southeast University School of Medicine (B.-C.L.), Nanjing, First Affiliated Hospital of Zhejiang University, Hangzhou (J.C.), First Affiliated Hospital of Nanchang University, Nanchang (L.L.), and the Department of Nephrology, Peking University People's Hospital, Beijing (L.Z.) - all in China; and FibroGen, San Francisco (R.L., C.W., C.L., T.N., L.S., K.-H.P.Y.).""}]",The New England journal of medicine,['10.1056/NEJMoa1813599'] 1404,23793983,Chemotherapy-induced amenorrhea: a prospective study of brain activation changes and neurocognitive correlates.,"Chemotherapy-induced amenorrhea (CIA) often occurs in pre- and peri-menopausal BC patients, and while cancer/chemotherapy and abrupt estrogen loss have separately been shown to affect cognition and brain function, studies of the cognitive effects of CIA are equivocal, and its effects on brain function are unknown. Functional MRI (fMRI) during a working memory task was used to prospectively assess the pattern of brain activation and deactivation prior to and 1 month after chemotherapy in BC patients who experienced CIA (n = 9), post-menopausal BC patients undergoing chemotherapy (n = 9), and pre- and post-menopausal healthy controls (n = 6 each). Neurocognitive testing was also performed at both time points. Repeated measures general linear models were used to assess statistical significance, and age was a covariate in all analyses. We observed a group-by-time interaction in the combined magnitudes of brain activation and deactivation (p = 0.006): the CIA group increased in magnitude from baseline to post-treatment while other groups maintained similar levels over time. Further, the change in brain activity magnitude in CIA was strongly correlated with change in processing speed neurocognitive testing score (r = 0.837 p = 0.005), suggesting this increase in brain activity reflects effective cognitive compensation. Our results demonstrate prospectively that the pattern of change in brain activity from pre- to post-chemotherapy varies according to pre-treatment menopausal status. Cognitive correlates add to the potential clinical significance of these findings. These findings have implications for risk appraisal and development of prevention or treatment strategies for cognitive changes in CIA.",2013,We observed a group-by-time interaction in the combined magnitudes of brain activation and deactivation (p = 0.006): the CIA group increased in magnitude from baseline to post-treatment while other groups maintained similar levels over time.,"['BC patients who experienced CIA (n\u2009=\u20099), post-menopausal BC patients undergoing chemotherapy (n\u2009=\u20099), and pre- and post-menopausal healthy controls (n\u2009=\u20096 each']","['Chemotherapy-induced amenorrhea', 'Chemotherapy-induced amenorrhea (CIA']","['Functional MRI (fMRI', 'brain activity', 'processing speed neurocognitive testing score', 'brain activity reflects effective cognitive compensation', 'brain activation and deactivation', 'brain activity magnitude in CIA']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0025320', 'cui_str': 'Change of Life, Female'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0002453', 'cui_str': 'Amenorrhea'}]","[{'cui': 'C0376335', 'cui_str': 'fMRI'}, {'cui': 'C0443158', 'cui_str': 'Brain activity (observable entity)'}, {'cui': 'C0582591', 'cui_str': 'Processing speed (observable entity)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0558058', 'cui_str': 'Reflecting (finding)'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C0152058', 'cui_str': 'Compensation (finding)'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C1704240', 'cui_str': 'Magnitudes (qualifier value)'}]",,0.0172394,We observed a group-by-time interaction in the combined magnitudes of brain activation and deactivation (p = 0.006): the CIA group increased in magnitude from baseline to post-treatment while other groups maintained similar levels over time.,"[{'ForeName': 'Susan K', 'Initials': 'SK', 'LastName': 'Conroy', 'Affiliation': 'Center for Neuroimaging, Department of Radiology and Imaging Sciences, Indiana University School of Medicine, 355 W. 16th St., GH Suite 4100, Indianapolis, IN, 46202, USA.'}, {'ForeName': 'Brenna C', 'Initials': 'BC', 'LastName': 'McDonald', 'Affiliation': ''}, {'ForeName': 'Tim A', 'Initials': 'TA', 'LastName': 'Ahles', 'Affiliation': ''}, {'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'West', 'Affiliation': ''}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Saykin', 'Affiliation': ''}]",Brain imaging and behavior,['10.1007/s11682-013-9240-5'] 1405,32426884,"Disparate effects of adalimumab and fumaric acid esters on cardiovascular risk factors in psoriasis patients: results from a prospective, randomized, observer-blinded head-to-head trial.","BACKGROUND The effect of adalimumab and fumaric acid esters (FAE) on the cardiovascular risk associated with psoriasis has only been investigated scarcely in randomized controlled studies. OBJECTIVE The aim of this prospective, randomized controlled head-to-head trial was to compare the influence of adalimumab and FAE on cardiovascular disease markers in psoriasis patients. METHODS Sixty-five patients with moderate to severe plaque psoriasis were randomly assigned to adalimumab or FAE treatment for 6 months. Cardiovascular haemodynamic parameters [flow-mediated dilation (FMD), nitro-glycerine mediated dilation (NMD) and carotid intima-media thickness (CIMT), blood pressure] were assessed at baseline (v0) and after 6 months (v6). Cutaneous disease severity, inflammatory and lipid cardiovascular risk markers were analysed at baseline(v0), after 3 (v3) and 6 months (v6). RESULTS After 6 months of treatment FMD in the adalimumab group increased significantly [v0 5.9% (6.4% SD), v6 8.0% (4.8% SD), P = 0.048) but not in the FAE group. (v0 7.0% (4.1% SD), v6 8.4% (6.1% SD), P = 0.753]. This was paralleled by a significant decrease of high sensitive C-reactive protein (hsCRP) in the adalimumab group in comparison to the FAE group (v0: 0.39 mg/dL (0.38 SD), v6: 0.39 mg/dL (0.48 SD), P = 0.043). No significant changes were observed in any other haemodynamic parameters. FAE, however, additionally decreased total cholesterol (P = 0.046) and apolipoprotein B (P = 0.041) levels compared to adalimumab. Mean Psoriasis Area and Severity Index (psoriasis area severity score) reduction was greater but not significant (P = 0.116) under adalimumab treatment compared to FAE treatment [-71.1% (29.9 SD) vs. -54.6% (45.7%)]. CONCLUSION In our study, both treatments were documented to exert effects on the cardiovascular system. While adalimumab showed anti-inflammatory effects and improved FMD, FAE interacted favourably with the cholesterol metabolism.",2020,This was paralleled by a significant decrease of hsCRP in the adalimumab group in comparison to the FAE group (v0:,"['65 patients with moderate to severe plaque psoriasis', 'psoriasis patients']","['adalimumab and fumaric acid esters (FAE', 'adalimumab or FAE', 'adalimumab', 'adalimumab and FAE', 'adalimumab and fumaric acid esters', 'FAE']","['hsCRP', 'Mean PASI (psoriasis area severity score) reduction', 'total cholesterol (p=0,046) and apolipoprotein B (p=0,041) levels', 'Cardiovascular hemodynamic parameters (flow mediated dilation (FMD), nitro-glycerine mediated dilation (NMD) and carotid intima media thickness (CIMT), blood pressure', 'cardiovascular risk factors', 'anti-inflammatory effects and improved FMD, FAE', 'cardiovascular disease markers', 'Cutaneous disease severity, inflammatory and lipid cardiovascular risk markers', 'hemodynamic parameters']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0406317', 'cui_str': 'Chronic small plaque psoriasis'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}]","[{'cui': 'C1122087', 'cui_str': 'adalimumab'}, {'cui': 'C1959568', 'cui_str': 'Fumarate Esters'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0457451', 'cui_str': 'Severity score'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0003593', 'cui_str': 'Apolipoprotein B'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0012359', 'cui_str': 'Dilatation'}, {'cui': 'C0017861', 'cui_str': 'Glycerin'}, {'cui': 'C0162864', 'cui_str': 'Tunica intima'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0003209', 'cui_str': 'Antiinflammatory agent'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0016052', 'cui_str': 'Fibromuscular dysplasia'}, {'cui': 'C1959568', 'cui_str': 'Fumarate Esters'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C1522447', 'cui_str': 'Cutaneous route'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}]",65.0,0.0785267,This was paralleled by a significant decrease of hsCRP in the adalimumab group in comparison to the FAE group (v0:,"[{'ForeName': 'G', 'Initials': 'G', 'LastName': 'Holzer', 'Affiliation': 'Department of Dermatology, Medical University of Vienna, Austria.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Hoke', 'Affiliation': 'Department of Internal Medicine II, Division of Angiology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Sabeti-Sandor', 'Affiliation': 'Department of Internal Medicine II, Division of Angiology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Perkmann', 'Affiliation': 'Department of Laboratory Medicine, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Rauscher', 'Affiliation': 'Department of Dermatology, Medical University of Vienna, Austria.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Strassegger', 'Affiliation': 'Department of Dermatology, Donauspital, SMZ Ost, Vienna, Austria.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Radakovic', 'Affiliation': 'Department of Dermatology, Medical University of Vienna, Austria.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Tanew', 'Affiliation': 'Department of Dermatology, Medical University of Vienna, Austria.'}]",Journal of the European Academy of Dermatology and Venereology : JEADV,['10.1111/jdv.16635'] 1406,32421444,"Neoadjuvant Chemotherapy in High-Risk Soft Tissue Sarcomas: Final Results of a Randomized Trial From Italian (ISG), Spanish (GEIS), French (FSG), and Polish (PSG) Sarcoma Groups.","PURPOSE To determine whether the administration of histology-tailored neoadjuvant chemotherapy (HT) was superior to the administration of standard anthracycline plus ifosfamide neoadjuvant chemotherapy (A+I) in high-risk soft tissue sarcoma (STS) of an extremity or the trunk wall. PATIENTS AND METHODS This was a randomized, open-label, phase III trial. Patients had localized high-risk STS (grade 3; size, ≥ 5 cm) of an extremity or trunk wall, belonging to one of the following five histologic subtypes: high-grade myxoid liposarcoma (HG-MLPS); leiomyosarcoma (LMS), synovial sarcoma (SS), malignant peripheral nerve sheath tumor (MPNST), and undifferentiated pleomorphic sarcoma (UPS). Patients were randomly assigned in a 1:1 ratio to receive three cycles of A+I or HT. The HT regimens were as follows: trabectedin in HG-MLPS; gemcitabine plus dacarbazine in LMS; high-dose prolonged-infusion ifosfamide in SS; etoposide plus ifosfamide in MPNST; and gemcitabine plus docetaxel in UPS. Primary and secondary end points were disease-free survival (DFS) and overall survival (OS), estimated using the Kaplan-Meier method and compared using Cox models adjusted for treatment and stratification factors. The study is registered at ClinicalTrials.gov (identifier NCT01710176). RESULTS Between May 2011 and May 2016, 287 patients (UPS: n = 97 [33.8%]; HG-MLPS: n = 65 [22.6%]; SS: n = 70 [24.4%]; MPNST: n = 27 [9.4%]; and LMS: n = 28 [9.8%]) were randomly assigned to either A+I or HT. At the final analysis, with a median follow-up of 52 months, the projected DFS and OS probabilities were 0.55 and 0.47 (log-rank P = .323) and 0.76 and 0.66 (log-rank P = .018) at 60 months in the A+I arm and HT arm, respectively. No treatment-related deaths were observed. CONCLUSION In a population of patients with localized high-risk STS, HT was not associated with a better DFS or OS, suggesting that A+I should remain the regimen to choose whenever neoadjuvant chemotherapy is used in patients with high-risk STS.",2020,"In a population of patients with localized high-risk STS, HT was not associated with a better DFS or OS, suggesting that A+I should remain the regimen to choose whenever neoadjuvant chemotherapy is used in patients with high-risk STS.","['high-risk soft tissue sarcoma (STS) of an extremity or the trunk wall', 'patients with high-risk STS', 'Italian (ISG), Spanish (GEIS), French (FSG), and Polish (PSG', 'High-Risk Soft Tissue Sarcomas', 'Patients had localized high-risk STS (grade 3; size, ≥ 5 cm) of an extremity or trunk wall, belonging to one of the following five histologic subtypes: high-grade myxoid liposarcoma (HG-MLPS); leiomyosarcoma (LMS), synovial sarcoma (SS), malignant peripheral nerve sheath tumor (MPNST), and undifferentiated pleomorphic sarcoma (UPS', '287 patients (UPS: n = 97 [33.8%]; HG-MLPS: n = 65 [22.6%]; SS: n = 70 [24.4%]; MPNST: n = 27 [9.4%]; and LMS: n = 28 [9.8']","['ifosfamide in SS; etoposide plus ifosfamide', 'histology-tailored neoadjuvant chemotherapy (HT', 'Neoadjuvant Chemotherapy', 'A+I or HT', 'gemcitabine plus docetaxel', 'standard anthracycline plus ifosfamide neoadjuvant chemotherapy (A+I', 'gemcitabine plus dacarbazine']","['projected DFS and OS probabilities', 'disease-free survival (DFS) and overall survival (OS), estimated using the Kaplan-Meier method and compared using Cox models adjusted for treatment and stratification factors']","[{'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C1261473', 'cui_str': 'Sarcoma'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0459558', 'cui_str': 'Body wall structure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022275', 'cui_str': 'Italian language'}, {'cui': 'C0037750', 'cui_str': 'Spanish language'}, {'cui': 'C0376246', 'cui_str': 'French language'}, {'cui': 'C0032376', 'cui_str': 'Polish language'}, {'cui': 'C0162701', 'cui_str': 'Polysomnography'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0392752', 'cui_str': 'Localized'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C1301142', 'cui_str': 'WHO tumor classification'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0206634', 'cui_str': 'Myxoid liposarcoma'}, {'cui': 'C0023269', 'cui_str': 'Leiomyosarcoma'}, {'cui': 'C0039101', 'cui_str': 'Synovial sarcoma'}, {'cui': 'C0751690', 'cui_str': 'Malignant peripheral nerve sheath tumor'}, {'cui': 'C0334463', 'cui_str': 'Fibrous histiocytoma, malignant'}, {'cui': 'C4517682', 'cui_str': '287'}]","[{'cui': 'C0020823', 'cui_str': 'Ifosfamide'}, {'cui': 'C0039101', 'cui_str': 'Synovial sarcoma'}, {'cui': 'C0015133', 'cui_str': 'Etoposide'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0019638', 'cui_str': 'Histology'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0003234', 'cui_str': 'Anthracycline'}, {'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0010927', 'cui_str': 'Dacarbazine'}]","[{'cui': 'C0016538', 'cui_str': 'Projections and Predictions'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0010234', 'cui_str': 'Cox Models'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",,0.10756,"In a population of patients with localized high-risk STS, HT was not associated with a better DFS or OS, suggesting that A+I should remain the regimen to choose whenever neoadjuvant chemotherapy is used in patients with high-risk STS.","[{'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Gronchi', 'Affiliation': 'Department of Surgery, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS), Istituto Nazionale dei Tumori, Milan, Italy.'}, {'ForeName': 'Emanuela', 'Initials': 'E', 'LastName': 'Palmerini', 'Affiliation': 'Chemotherapy Unit, IRCCS, Istituto Ortopedico Rizzoli, Bologna, Italy.'}, {'ForeName': 'Vittorio', 'Initials': 'V', 'LastName': 'Quagliuolo', 'Affiliation': 'Department of Surgery, Istituto Clinico Humanitas, Rozzano, Italy.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Martin Broto', 'Affiliation': 'Medical Oncology Department, University Hospital Virgen del Rocio, Sevilla, Spain.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Lopez Pousa', 'Affiliation': 'Department of Cancer Medicine, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Grignani', 'Affiliation': ""Department of Cancer Medicine, Fondazione del Piemonte per l'Oncologia, IRCCS, Candiolo, Turin, Italy.""}, {'ForeName': 'Antonella', 'Initials': 'A', 'LastName': 'Brunello', 'Affiliation': 'Department of Oncology, Medical Oncology 1 Unit, Istituto Oncologico Veneto, IRCCS, Padova, Italy.'}, {'ForeName': 'Jean-Yves', 'Initials': 'JY', 'LastName': 'Blay', 'Affiliation': 'Department of Cancer Medicine, Centre Léon Bérard Cancer Center, Lyon, France.'}, {'ForeName': 'Oscar', 'Initials': 'O', 'LastName': 'Tendero', 'Affiliation': 'Department of Surgery, Hospital Universitari Son Espases, Palma de Mallorca, Spain.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Diaz Beveridge', 'Affiliation': 'Department of Cancer Medicine, Hospital Universitari i Politècnic La Fe, Valencia, Spain.'}, {'ForeName': 'Virginia', 'Initials': 'V', 'LastName': 'Ferraresi', 'Affiliation': 'Department of Cancer Medicine, Istituto Regina Elena, Rome, Italy.'}, {'ForeName': 'Iwona', 'Initials': 'I', 'LastName': 'Lugowska', 'Affiliation': 'Department of Soft Tissue/Bone Sarcoma and Melanoma, Centrum Onkologii, Instytutim, Marii Sklodowskiej-Curie, Warszawa, Poland.'}, {'ForeName': 'Domenico Franco', 'Initials': 'DF', 'LastName': 'Merlo', 'Affiliation': 'Research and Statistics Infrastructure, Azienda Unità Sanitaria Locale, IRCCS, Reggio Emilia, Italy.'}, {'ForeName': 'Valeria', 'Initials': 'V', 'LastName': 'Fontana', 'Affiliation': 'Clinical Trial Center and Department of Epidemiology, IRCCS Azienda Ospedaliera Universitaria San Martino, IST Istituto Nazionale per la Ricerca sul Cancro, Genova, Italy.'}, {'ForeName': 'Emanuela', 'Initials': 'E', 'LastName': 'Marchesi', 'Affiliation': 'Clinical Trial Center, Italian Sarcoma Group, Bologna, Italy.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Braglia', 'Affiliation': 'Research and Statistics Infrastructure, Azienda Unità Sanitaria Locale, IRCCS, Reggio Emilia, Italy.'}, {'ForeName': 'Davide Maria', 'Initials': 'DM', 'LastName': 'Donati', 'Affiliation': 'Department of Orthopedic Oncology, Istituto Ortopedico Rizzoli, Bologna, Italy.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Palassini', 'Affiliation': 'Department of Cancer Medicine, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Bianchi', 'Affiliation': 'Department of Orthopedic Oncology, Istituto Ortopedico Rizzoli, Bologna, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Marrari', 'Affiliation': 'Department of Cancer Medicine, Istituto Clinico Humanitas, Rozzano, Italy.'}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Morosi', 'Affiliation': 'Department of Radiology, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Stacchiotti', 'Affiliation': 'Department of Cancer Medicine, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Bagué', 'Affiliation': 'Department of Pathology, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain.'}, {'ForeName': 'Jean Michel', 'Initials': 'JM', 'LastName': 'Coindre', 'Affiliation': 'Department of Pathology, Institut Bergonié, Bordeaux, France.'}, {'ForeName': 'Angelo Paolo', 'Initials': 'AP', 'LastName': 'Dei Tos', 'Affiliation': 'Department of Pathology, Treviso General Hospital Treviso, Padova, Italy.'}, {'ForeName': 'Piero', 'Initials': 'P', 'LastName': 'Picci', 'Affiliation': 'Laboratory of Oncologic Research, Istituto Ortopedico Rizzoli, Bologna, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Bruzzi', 'Affiliation': 'Clinical Trial Center and Department of Epidemiology, IRCCS Azienda Ospedaliera Universitaria San Martino, IST Istituto Nazionale per la Ricerca sul Cancro, Genova, Italy.'}, {'ForeName': 'Paolo Giovanni', 'Initials': 'PG', 'LastName': 'Casali', 'Affiliation': 'Department of Cancer Medicine, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.03289'] 1407,31300264,Caloric vestibular stimulation for the management of motor and non-motor symptoms in Parkinson's disease.,"INTRODUCTION A recent case study showed that repeated sessions of caloric vestibular stimulation (CVS) relieved motor and non-motor symptoms associated with Parkinson's disease (PD). Here we sought to confirm these results in a prospective, double-blind, randomized, placebo treatment-controlled study. METHODS 33 PD subjects receiving stable anti-Parkinsonian therapy completed an active (n = 16) or placebo (n = 17) treatment period. Subjects self-administered CVS at home twice-daily via a portable, pre-programmed, solid-state ThermoNeuroModulation (TNM™) device, which delivered continually-varying thermal waveforms through aluminum ear-probes mounted on a wearable headset. Subjects were followed over a 4-week baseline period, 8 weeks of treatment and then at 5- and 24-weeks post-treatment. At each study visit, standardized clinical assessments were conducted during ON-medication states to evaluate changes in motor and non-motor symptoms, activities of daily living, and quality of life ratings. RESULTS Change scores between baseline and the end of treatment showed that active-arm subjects demonstrated clinically-relevant reductions in motor and non-motor symptoms that were significantly greater than placebo-arm subjects. Active treatment was also associated with improved scores on activities of daily living assessments. Therapeutic gains were still evident 5 weeks after the end of active treatment but had started to recede at 24 weeks follow-up. No serious adverse events were associated with device use, and there was high participant satisfaction and tolerability of treatment. CONCLUSION The results provide evidence that repeated CVS can provide safe and enduring adjuvant relief for motor and non-motor symptoms associated with PD.",2019,The results provide evidence that repeated CVS can provide safe and enduring adjuvant relief for motor and non-motor symptoms associated with PD.,"['33 PD subjects receiving stable anti-Parkinsonian therapy completed an active (n\u202f=\u202f16) or', ""Parkinson's disease""]","['Caloric vestibular stimulation', 'placebo', 'solid-state ThermoNeuroModulation (TNM™) device, which delivered continually-varying thermal waveforms through aluminum ear-probes mounted on a wearable headset', 'caloric vestibular stimulation (CVS']","['motor and non-motor symptoms', 'serious adverse events', 'Therapeutic gains', 'activities of daily living assessments', 'changes in motor and non-motor symptoms, activities of daily living, and quality of life ratings']","[{'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0030567', 'cui_str': 'Idiopathic Parkinson Disease'}]","[{'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0302909', 'cui_str': 'Solid substance (substance)'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0450448', 'cui_str': 'Waveforms (qualifier value)'}, {'cui': 'C0202311', 'cui_str': 'Aluminum measurement (procedure)'}, {'cui': 'C0013443', 'cui_str': 'Vestibulocochlear Apparatus'}, {'cui': 'C3179165', 'cui_str': 'Probe (methazole)'}, {'cui': 'C0181909', 'cui_str': 'Mount (physical object)'}]","[{'cui': 'C0426980', 'cui_str': 'Motor symptoms (finding)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0001288', 'cui_str': 'ADL'}, {'cui': 'C0034380'}]",,0.22612,The results provide evidence that repeated CVS can provide safe and enduring adjuvant relief for motor and non-motor symptoms associated with PD.,"[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Wilkinson', 'Affiliation': 'School of Psychology, University of Kent, Canterbury, UK. Electronic address: dtw@kent.ac.uk.'}, {'ForeName': 'Aleksandra', 'Initials': 'A', 'LastName': 'Podlewska', 'Affiliation': 'School of Psychology, University of Kent, Canterbury, UK.'}, {'ForeName': 'Sarah E', 'Initials': 'SE', 'LastName': 'Banducci', 'Affiliation': 'Scion NeuroStim, LLC, Durham, NC, USA.'}, {'ForeName': 'Tracy', 'Initials': 'T', 'LastName': 'Pellat-Higgins', 'Affiliation': 'Centre for Health Services Studies, University of Kent, Canterbury, UK.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Slade', 'Affiliation': 'Yale University, School of Public Health, New Haven, CT, 06510, USA.'}, {'ForeName': 'Mayur', 'Initials': 'M', 'LastName': 'Bodani', 'Affiliation': 'Neuropsychiatry Service, Kent & Medway NHS and Social Care Partnership Trust, UK.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Sakel', 'Affiliation': 'East Kent Neuro-Rehabilitation Service, East Kent Hospitals University NHS Foundation Trust, Canterbury, UK.'}, {'ForeName': 'Lanty', 'Initials': 'L', 'LastName': 'Smith', 'Affiliation': 'Scion NeuroStim, LLC, Durham, NC, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'LeWitt', 'Affiliation': ""Parkinson's Disease & Movement Disorders Program, Henry Ford Hospital and Wayne State University School of Medicine, West Bloomfield, MI, 48322, USA.""}, {'ForeName': 'Kristen K', 'Initials': 'KK', 'LastName': 'Ade', 'Affiliation': 'Scion NeuroStim, LLC, Durham, NC, USA.'}]",Parkinsonism & related disorders,['10.1016/j.parkreldis.2019.05.031'] 1408,31122792,Parent eReferral to Tobacco Quitline: A Pragmatic Randomized Trial in Pediatric Primary Care.,"INTRODUCTION Quitlines are effective in helping smokers quit, but pediatrician quitline referral rates are low, and few parents who smoke use the service. This study compared enrollment of parents who smoke in the quitline using electronic referral with that using manual referral. STUDY DESIGN The study was designed as a pragmatic RCT. SETTING/PARTICIPANTS Participants were recruited from one large, urban pediatric primary care site in Philadelphia, Pennsylvania with a high percentage of low-income families. Participants included adult parents who smoked and were present at their child's healthcare visit. INTERVENTION Pediatricians screened for tobacco use; smokers were given brief advice to quit and, if interested in quitting, were referred to the quitline. The eReferral (""warm handoff"") involved electronically sending parent information to the quitline (parent received a call within 24-48 hours). Control group procedures were identical to eReferral, except the quitline number was provided to the parent. Data were collected between March 2017 and February 2018 and analyzed in 2018. MAIN OUTCOME MEASURES The primary outcome was the proportion of parents enrolled in quitline treatment. Secondary outcomes included parent factors (e.g., demographics, nicotine dependence, and quitting motivation) associated with successful enrollment. Number of quitline contacts was also explored. RESULTS During the study period, in the eReferral group, 10.3% (24 of 233) of parents who smoked and were interested in quitting enrolled in the quitline, whereas only 2.0% (5 of 251) of them in the control group enrolled in the quitline-a difference of 8.3% (95% CI=4.0, 12.6). Parents aged ≥50 years enrolled in the quitline more frequently. Although more parents in the eReferral group connected to the quitline, among parents who had at least one quitline contact, there was no significant difference in the mean number of quitline contacts between eReferral and control groups (mean, 2.04 vs 2.40 calls; difference, 0.36 [95% CI=0.35, 1.06]). CONCLUSIONS Smoking parent eReferral from pediatric primary care may increase quitline enrollment and could be adopted by practices interested in increasing rates of parent treatment. TRIAL REGISTRATION This study is registered at www.clinicaltrials.gov NCT02997735.",2019,"During the study period, in the eReferral group, 10.3% (24 of 233) of parents who smoked and were interested in quitting enrolled in the quitline, whereas only 2.0% (5 of 251) of them in the control group enrolled in the quitline-a difference of 8.3% (95% CI=4.0, 12.6).","['parents who smoke in the quitline using electronic referral with that using manual referral', ""Participants included adult parents who smoked and were present at their child's healthcare visit"", 'Parent eReferral to Tobacco Quitline', 'Participants were recruited from one large, urban pediatric primary care site in Philadelphia, Pennsylvania with a high percentage of low-income families', 'Parents aged ≥50 years enrolled in the quitline more frequently', 'Data were collected between March 2017 and February 2018 and analyzed in 2018']",[],"['proportion of parents enrolled in quitline treatment', 'parent factors (e.g., demographics, nicotine dependence, and quitting motivation) associated with successful enrollment', 'mean number of quitline contacts']","[{'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C4281784', 'cui_str': 'Electronics'}, {'cui': 'C0034927', 'cui_str': 'Referral'}, {'cui': 'C0175674', 'cui_str': 'Manual (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C0040329', 'cui_str': 'Tobacco Products'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0031525', 'cui_str': 'Philadelphia'}, {'cui': 'C0030853', 'cui_str': 'Pennsylvania'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0302604', 'cui_str': 'Low income'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332183', 'cui_str': 'Frequent (qualifier value)'}]",[],"[{'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0028043', 'cui_str': 'Nicotine Dependence'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0332281', 'cui_str': 'Associated with (attribute)'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}]",,0.101209,"During the study period, in the eReferral group, 10.3% (24 of 233) of parents who smoked and were interested in quitting enrolled in the quitline, whereas only 2.0% (5 of 251) of them in the control group enrolled in the quitline-a difference of 8.3% (95% CI=4.0, 12.6).","[{'ForeName': 'Brian P', 'Initials': 'BP', 'LastName': 'Jenssen', 'Affiliation': ""Department of Pediatrics, University of Pennsylvania, Philadelphia, Pennsylvania; PolicyLab and the Center for Pediatric Clinical Effectiveness, The Children's Hospital of Philadelphia, Philadelphia, Pennsylvania; Department of Biomedical and Health Informatics, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania. Electronic address: jenssenb@email.chop.edu.""}, {'ForeName': 'Naveen', 'Initials': 'N', 'LastName': 'Muthu', 'Affiliation': ""Department of Pediatrics, University of Pennsylvania, Philadelphia, Pennsylvania; PolicyLab and the Center for Pediatric Clinical Effectiveness, The Children's Hospital of Philadelphia, Philadelphia, Pennsylvania; Department of Biomedical and Health Informatics, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania.""}, {'ForeName': 'Mary Kate', 'Initials': 'MK', 'LastName': 'Kelly', 'Affiliation': ""PolicyLab and the Center for Pediatric Clinical Effectiveness, The Children's Hospital of Philadelphia, Philadelphia, Pennsylvania.""}, {'ForeName': 'Hilary', 'Initials': 'H', 'LastName': 'Baca', 'Affiliation': 'National Jewish Health, Denver, Colorado.'}, {'ForeName': 'Justine', 'Initials': 'J', 'LastName': 'Shults', 'Affiliation': 'Department of Biostatistics and Epidemiology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Robert W', 'Initials': 'RW', 'LastName': 'Grundmeier', 'Affiliation': ""Department of Pediatrics, University of Pennsylvania, Philadelphia, Pennsylvania; PolicyLab and the Center for Pediatric Clinical Effectiveness, The Children's Hospital of Philadelphia, Philadelphia, Pennsylvania; Department of Biomedical and Health Informatics, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania.""}, {'ForeName': 'Alexander G', 'Initials': 'AG', 'LastName': 'Fiks', 'Affiliation': ""Department of Pediatrics, University of Pennsylvania, Philadelphia, Pennsylvania; PolicyLab and the Center for Pediatric Clinical Effectiveness, The Children's Hospital of Philadelphia, Philadelphia, Pennsylvania; Department of Biomedical and Health Informatics, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania.""}]",American journal of preventive medicine,['10.1016/j.amepre.2019.03.005'] 1409,22573470,Patient perspectives on participation in the ENABLE II randomized controlled trial of a concurrent oncology palliative care intervention: benefits and burdens.,"BACKGROUND ENABLE (Educate, Nurture, Advise Before Life Ends) II was one of the first randomized controlled trials (RCTs) examining the effects of a concurrent oncology palliative care intervention on quality of life, mood, and symptom control for advanced cancer patients and their caregivers. However, little is known about how participants experience early palliative care and the benefits and burdens of participating in a palliative care clinical trial. AIM To gain a deeper understanding of participants' perspectives of the intervention and palliative care trial participation. DESIGN A qualitative descriptive study using thematic analysis to determine benefits and burdens of a new palliative care intervention and trial participation. SETTING/PARTICIPANTS Of the 72 participants who were alive when the study commenced, 53 agreed to complete an in-depth, semi-structured interview regarding the ENABLE II intervention and clinical trial participation. RESULTS Participants' perceptions of intervention benefits were represented by four themes: enhanced problem-solving skills, better coping, feeling empowered, and feeling supported or reassured. Three themes related to trial participation: helping future patients and contributing to science, gaining insight through completion of questionnaires, and trial/intervention aspects to improve. CONCLUSIONS The benefits of the intervention and the positive aspects of trial participation outweighed trial ""burdens"". This study raises additional important questions relevant to future trial design and intervention development: when should a palliative care intervention be initiated and what aspects of self-care and healthy living should be offered in addition to palliative content for advanced cancer patients when they are feeling well?",2013,"RESULTS Participants' perceptions of intervention benefits were represented by four themes: enhanced problem-solving skills, better coping, feeling empowered, and feeling supported or reassured.","['advanced cancer patients', 'Of the 72 participants who were alive when the study commenced', 'advanced cancer patients and their caregivers']",['concurrent oncology palliative care intervention'],"['enhanced problem-solving skills, better coping, feeling empowered, and feeling supported or reassured', 'quality of life, mood, and symptom control']","[{'cui': 'C0877373', 'cui_str': 'Advanced cancer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2584946', 'cui_str': 'Alive'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}]","[{'cui': 'C0205420', 'cui_str': 'Concurrent (qualifier value)'}, {'cui': 'C0700049', 'cui_str': 'Palliative care'}]","[{'cui': 'C3669643', 'cui_str': 'Problem solving (qualifier value)'}, {'cui': 'C0332272', 'cui_str': 'Better (qualifier value)'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0562342', 'cui_str': 'Empowered (finding)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0557055', 'cui_str': 'Reassuring (procedure)'}, {'cui': 'C0034380'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C1274136', 'cui_str': 'Symptom control'}]",72.0,0.166868,"RESULTS Participants' perceptions of intervention benefits were represented by four themes: enhanced problem-solving skills, better coping, feeling empowered, and feeling supported or reassured.","[{'ForeName': 'Cristine', 'Initials': 'C', 'LastName': 'Maloney', 'Affiliation': 'Department of Anesthesiology, Section of Palliative Medicine, Dartmouth-Hitchcock Medical Center, Lebanon, NH, USA.'}, {'ForeName': 'Kathleen Doyle', 'Initials': 'KD', 'LastName': 'Lyons', 'Affiliation': ''}, {'ForeName': 'Zhongze', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Hegel', 'Affiliation': ''}, {'ForeName': 'Tim A', 'Initials': 'TA', 'LastName': 'Ahles', 'Affiliation': ''}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Bakitas', 'Affiliation': ''}]",Palliative medicine,['10.1177/0269216312445188'] 1410,23646838,Correcting injunctive norm misperceptions motivates behavior change: a randomized controlled sun protection intervention.,"OBJECTIVE Despite long-standing social psychological research supporting the influence of injunctive norms (i.e., what is commonly approved or disapproved) on behavior, support for this influence on health behaviors is limited. We examined the utility of correcting misperceptions of injunctive norms for improving sun protection and whether changes in attitudes mediated the injunctive norm-intention relationship. METHOD At baseline 263 community residing primarily White women, aged 37 to 77 years, reported their beliefs about sun protection and tanning and their perceptions of ""typical women's"" approval of sun protection versus tanning. Women underestimated approval of sun protection and overestimated approval of tanning. In a randomized trial, 189 of these women received either information about sun protection or information plus personalized normative feedback (PNF). PNF compared each woman's own perceptions of typical women's approval of tanning and sun protection with actual normative values, both measured at baseline. PNF communicated that most women approve of others who sun protect. RESULTS PNF led to more positive sun protection injunctive norms, attitudes, and intentions at immediate posttest and more positive intentions and self-reported behavior at 4-week follow-up. Baseline discrepancy between a woman's beliefs and actual normative values related negatively to changes in sun protection in the control condition but positively in the PNF condition. As hypothesized, changes in attitudes partially mediated the influence of PNF on changes in intentions. CONCLUSIONS The present research demonstrates the utility of correcting injunctive norm misperceptions for promoting healthy behaviors. That attitudes changed in response to PNF and mediated the norm-intention relationship suggests a method for influencing attitudes that may limit reactance.",2013,"RESULTS PNF led to more positive sun protection injunctive norms, attitudes, and intentions at immediate posttest and more positive intentions and self-reported behavior at 4-week follow-up.","['At baseline 263 community residing primarily White women, aged 37 to 77 years, reported their beliefs about sun protection and tanning and their perceptions of ""typical women\'s"" approval of sun protection versus tanning']","['information about sun protection or information plus personalized normative feedback (PNF', 'PNF']","['positive sun protection injunctive norms, attitudes, and intentions at immediate posttest and more positive intentions and self-reported behavior']","[{'cui': 'C4517671', 'cui_str': '263'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0038817', 'cui_str': 'Sunshine'}, {'cui': 'C0039295', 'cui_str': 'Tannings'}]","[{'cui': 'C0038817', 'cui_str': 'Sunshine'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}]","[{'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0038817', 'cui_str': 'Sunshine'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}]",,0.100839,"RESULTS PNF led to more positive sun protection injunctive norms, attitudes, and intentions at immediate posttest and more positive intentions and self-reported behavior at 4-week follow-up.","[{'ForeName': 'Allecia E', 'Initials': 'AE', 'LastName': 'Reid', 'Affiliation': 'Department of Psychology, Arizona State University, USA. allecia.reid@yale.edu'}, {'ForeName': 'Leona S', 'Initials': 'LS', 'LastName': 'Aiken', 'Affiliation': ''}]","Health psychology : official journal of the Division of Health Psychology, American Psychological Association",['10.1037/a0028140'] 1411,31870766,"Long-term safety and efficacy of closed-loop spinal cord stimulation to treat chronic back and leg pain (Evoke): a double-blind, randomised, controlled trial.","BACKGROUND Spinal cord stimulation has been an established treatment for chronic back and leg pain for more than 50 years; however, outcomes are variable and unpredictable, and objective evidence of the mechanism of action is needed. A novel spinal cord stimulation system provides the first in vivo, real-time, continuous objective measure of spinal cord activation in response to therapy via recorded evoked compound action potentials (ECAPs) in patients during daily use. These ECAPs are also used to optimise programming and deliver closed-loop spinal cord stimulation by adjusting the stimulation current to maintain activation within patients' therapeutic window. We aimed to examine pain relief and the extent of spinal cord activation with ECAP-controlled closed-loop versus fixed-output, open-loop spinal cord stimulation for the treatment of chronic back and leg pain. METHODS This multicentre, double-blind, parallel-arm, randomised controlled trial was done at 13 specialist clinics, academic centres, and hospitals in the USA. Patients with chronic, intractable pain of the back and legs (Visual Analog Scale [VAS] pain score ≥60 mm; Oswestry Disability Index [ODI] score 41-80) who were refractory to conservative therapy, on stable pain medications, had no previous experience with spinal cord stimulation, and were appropriate candidates for a spinal cord stimulation trial were screened. Eligible patients were randomly assigned (1:1) to receive ECAP-controlled closed-loop spinal cord stimulation (investigational group) or fixed-output, open-loop spinal cord stimulation (control group). The randomisation sequence was computer generated with permuted blocks of size 4 and 6 and stratified by site. Patients, investigators, and site staff were masked to the treatment assignment. The primary outcome was the proportion of patients with a reduction of 50% or more in overall back and leg pain with no increase in pain medications. Non-inferiority (δ=10%) followed by superiority were tested in the intention-to-treat population at 3 months (primary analysis) and 12 months (additional prespecified analysis) after the permanent implant. This study is registered with ClinicalTrials.gov, NCT02924129, and is ongoing. FINDINGS Between Feb 21, 2017, and Feb 20, 2018, 134 patients were enrolled and randomly assigned (67 to each treatment group). The intention-to-treat analysis comprised 125 patients at 3 months (62 in the closed-loop group and 63 in the open-loop group) and 118 patients at 12 months (59 in the closed-loop group and 59 in the open-loop group). The primary outcome was achieved in a greater proportion of patients in the closed-loop group than in the open-loop group at 3 months (51 [82·3%] of 62 patients vs 38 [60·3%] of 63 patients; difference 21·9%, 95% CI 6·6-37·3; p=0·0052) and at 12 months (49 [83·1%] of 59 patients vs 36 [61·0%] of 59 patients; difference 22·0%, 6·3-37·7; p=0·0060). We observed no differences in safety profiles between the two groups. The most frequently reported study-related adverse events in both groups were lead migration (nine [7%] patients), implantable pulse generator pocket pain (five [4%]), and muscle spasm or cramp (three [2%]). INTERPRETATION ECAP-controlled closed-loop stimulation provided significantly greater and more clinically meaningful pain relief up to 12 months than open-loop spinal cord stimulation. Greater spinal cord activation seen in the closed-loop group suggests a mechanistic explanation for the superior results, which aligns with the putative mechanism of action for spinal cord stimulation and warrants further investigation. FUNDING Saluda Medical.",2020,"The primary outcome was achieved in a greater proportion of patients in the closed-loop group than in the open-loop group at 3 months (51 [82·3%] of 62 patients vs 38 [60·3%] of 63 patients; difference 21·9%, 95% CI 6·6-37·3; p=0·0052) and at 12 months (49 [83·1%] of 59 patients vs 36 [61·0%] of 59 patients; difference 22·0%, 6·3-37·7; p=0·0060).","['patients during daily use', 'chronic back and leg pain (Evoke', 'Eligible patients', 'Patients with chronic, intractable pain of the back and legs (Visual Analog Scale [VAS] pain score ≥60 mm', 'Between Feb 21, 2017, and Feb 20, 2018, 134 patients were enrolled and randomly assigned', '13 specialist clinics, academic centres, and hospitals in the USA']","['ECAP-controlled closed-loop spinal cord stimulation (investigational group) or fixed-output, open-loop spinal cord stimulation (control group', 'therapy via recorded evoked compound action potentials (ECAPs', 'closed-loop spinal cord stimulation', 'ECAP-controlled closed-loop versus fixed-output, open-loop spinal cord stimulation']","['pain relief', 'pain medications', 'muscle spasm or cramp', 'implantable pulse generator pocket pain', 'safety profiles', 'proportion of patients with a reduction of 50% or more in overall back and leg pain', 'meaningful pain relief']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0023222', 'cui_str': 'Pain in lower limb (finding)'}, {'cui': 'C1444748', 'cui_str': 'Provoked by (attribute)'}, {'cui': 'C0030200', 'cui_str': 'Refractory Pain'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C2732809', 'cui_str': 'Visual analog scale pain score (observable entity)'}, {'cui': 'C4517565', 'cui_str': 'One hundred and thirty-four'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0087009', 'cui_str': 'Specialists'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0443183', 'cui_str': 'Closed loop (qualifier value)'}, {'cui': 'C0394477', 'cui_str': 'Spinal Cord Stimulation'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0443218', 'cui_str': 'Fixed (qualifier value)'}, {'cui': 'C0559530', 'cui_str': 'Open loop (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C1444748', 'cui_str': 'Provoked by (attribute)'}, {'cui': 'C0205198', 'cui_str': 'Compound (qualifier value)'}, {'cui': 'C0001272', 'cui_str': 'Action Potentials'}]","[{'cui': 'C0451615', 'cui_str': 'Pain relief (procedure)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0037763', 'cui_str': 'Muscular Spasm'}, {'cui': 'C1446787', 'cui_str': 'Cramping'}, {'cui': 'C0034107', 'cui_str': 'Pulse'}, {'cui': 'C0237638', 'cui_str': 'Generator'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0023222', 'cui_str': 'Pain in lower limb (finding)'}]",134.0,0.450313,"The primary outcome was achieved in a greater proportion of patients in the closed-loop group than in the open-loop group at 3 months (51 [82·3%] of 62 patients vs 38 [60·3%] of 63 patients; difference 21·9%, 95% CI 6·6-37·3; p=0·0052) and at 12 months (49 [83·1%] of 59 patients vs 36 [61·0%] of 59 patients; difference 22·0%, 6·3-37·7; p=0·0060).","[{'ForeName': 'Nagy', 'Initials': 'N', 'LastName': 'Mekhail', 'Affiliation': 'Cleveland Clinic, Cleveland, OH, USA. Electronic address: mekhain@ccf.org.'}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Levy', 'Affiliation': 'Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.'}, {'ForeName': 'Timothy R', 'Initials': 'TR', 'LastName': 'Deer', 'Affiliation': 'The Spine and Nerve Center of The Virginias, Charleston, WV, USA.'}, {'ForeName': 'Leonardo', 'Initials': 'L', 'LastName': 'Kapural', 'Affiliation': 'Carolinas Pain Institute and Wake Forest University School of Medicine, Winston-Salem, NC, USA.'}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'Premier Pain Centers, Shrewsbury, NJ, USA.'}, {'ForeName': 'Kasra', 'Initials': 'K', 'LastName': 'Amirdelfan', 'Affiliation': 'IPM Medical Group, Walnut Creek, CA, USA.'}, {'ForeName': 'Corey W', 'Initials': 'CW', 'LastName': 'Hunter', 'Affiliation': 'Ainsworth Institute of Pain Management, New York, NY, USA.'}, {'ForeName': 'Steven M', 'Initials': 'SM', 'LastName': 'Rosen', 'Affiliation': 'Delaware Valley Pain and Spine Institute, Trevose, PA, USA.'}, {'ForeName': 'Shrif J', 'Initials': 'SJ', 'LastName': 'Costandi', 'Affiliation': 'Cleveland Clinic, Cleveland, OH, USA.'}, {'ForeName': 'Steven M', 'Initials': 'SM', 'LastName': 'Falowski', 'Affiliation': 'Neurosurgical Associates of Lancaster, Lancaster, PA, USA.'}, {'ForeName': 'Abram H', 'Initials': 'AH', 'LastName': 'Burgher', 'Affiliation': 'HOPE Research-TPC, Phoenix, AZ, USA.'}, {'ForeName': 'Jason E', 'Initials': 'JE', 'LastName': 'Pope', 'Affiliation': 'Evolve Restorative Center, Santa Rosa, CA, USA.'}, {'ForeName': 'Christopher A', 'Initials': 'CA', 'LastName': 'Gilmore', 'Affiliation': 'Center for Clinical Research, Winston-Salem, NC, USA.'}, {'ForeName': 'Farooq A', 'Initials': 'FA', 'LastName': 'Qureshi', 'Affiliation': ""St Luke's Spine & Pain Associates, Easton, PA, USA.""}, {'ForeName': 'Peter S', 'Initials': 'PS', 'LastName': 'Staats', 'Affiliation': 'Premier Pain Centers, Shrewsbury, NJ, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Scowcroft', 'Affiliation': 'Pain Management Associates, Independence, MO, USA.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Carlson', 'Affiliation': 'Arizona Pain, Glendale, AZ, USA.'}, {'ForeName': 'Christopher K', 'Initials': 'CK', 'LastName': 'Kim', 'Affiliation': 'The Spine and Nerve Center of The Virginias, Charleston, WV, USA.'}, {'ForeName': 'Michael I', 'Initials': 'MI', 'LastName': 'Yang', 'Affiliation': 'Summit Pain Alliance, Santa Rosa, CA, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Stauss', 'Affiliation': 'Advanced Pain Management, Greenfield, WI, USA.'}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Poree', 'Affiliation': 'University of California at San Francisco, San Francisco, CA, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Neurology,['10.1016/S1474-4422(19)30414-4'] 1412,31402562,miRNA expression changes during the course of neoadjuvant bevacizumab and chemotherapy treatment in breast cancer.,"One of the hallmarks of cancer is sustained angiogenesis. Favorable results have been reported in some breast cancer (BC) patients receiving antiangiogenic therapy with bevacizumab (Bev) in combination with chemotherapy, and further knowledge on how Bev can be optimally combined with conventional treatment to increase efficacy is strongly needed. In this randomized, neoadjuvant phase II clinical trial, 132 patients with HER2-negative, nonmetastatic BC were treated with Bev in combination with sequential chemotherapy. Biopsies were sampled before treatment, after 12 weeks with anthracycline and after taxane therapy at week 25. MicroRNA (miRNA) expression profiling was performed on biopsies from each time point. Altogether, 241 biopsies were analyzed with the aim of identifying miRNA-based biomarkers of response to therapy. Results from the miRNA analyses were reported for the ER-positive cohort, which were previously demonstrated to benefit from antiangiogenic therapy in this study. For both treatment arms of this cohort, significantly different expression was observed for 217 miRNAs between objective responding and nonresponding patients before treatment initiation. These miRNAs have been linked to regulation of epithelial-mesenchymal transition, metastasis, and tumor growth, among other processes. Bev in combination with chemotherapy resulted in similar miRNA changes to chemotherapy alone. However, the deregulation of miRNA expression occurred earlier in the Bev arm. In both arms, tumor suppressor miRNAs were found upregulated after treatment, while oncogenic miRNAs were downregulated in the Bev arm. Patients responding to Bev showed a strong correlation between deregulated miRNAs and decreased proliferation score during the course of treatment, with downregulation of miR-4465 as the strongest indicator of reduced proliferation. Integrative analyses at miRNA-, gene-, and protein expression further indicated a longitudinal decrease in proliferation. Altogether, the results indicate that proliferation might represent a predictive factor for increased Bev sensitivity, which may aid in the identification of patients who could potentially benefit from Bev.",2019,"Patients responding to Bev showed a strong correlation between deregulated miRNAs and decreased proliferation score during the course of treatment, with downregulation of miR-4465 as the strongest indicator of reduced proliferation.","['breast cancer', '132 patients with HER2-negative, nonmetastatic BC']","['neoadjuvant bevacizumab and chemotherapy', 'antiangiogenic therapy with bevacizumab (Bev', 'Bev in combination with sequential chemotherapy', 'chemotherapy', 'anthracycline and after taxane therapy']","['proliferation score', 'tumor suppressor miRNAs', 'miRNA expression']","[{'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4087376', 'cui_str': 'HER2 negative'}]","[{'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C2363719', 'cui_str': 'Antiangiogenic therapy'}, {'cui': 'C0282564', 'cui_str': 'Anthracyclines'}, {'cui': 'C0796419', 'cui_str': 'Taxanes'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0334094', 'cui_str': 'Proliferation (morphologic abnormality)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C1101610', 'cui_str': 'miRNA'}, {'cui': 'C3854321', 'cui_str': 'Expression'}]",132.0,0.0208022,"Patients responding to Bev showed a strong correlation between deregulated miRNAs and decreased proliferation score during the course of treatment, with downregulation of miR-4465 as the strongest indicator of reduced proliferation.","[{'ForeName': 'Evita Maria', 'Initials': 'EM', 'LastName': 'Lindholm', 'Affiliation': 'Department of Cancer Genetics, Institute for Cancer Research, The Norwegian Radium Hospital, Oslo University Hospital, Norway.'}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Ragle Aure', 'Affiliation': 'Department of Cancer Genetics, Institute for Cancer Research, The Norwegian Radium Hospital, Oslo University Hospital, Norway.'}, {'ForeName': 'Mads Haugland', 'Initials': 'MH', 'LastName': 'Haugen', 'Affiliation': 'Department of Cancer Genetics, Institute for Cancer Research, The Norwegian Radium Hospital, Oslo University Hospital, Norway.'}, {'ForeName': 'Kristine', 'Initials': 'K', 'LastName': 'Kleivi Sahlberg', 'Affiliation': 'Department of Cancer Genetics, Institute for Cancer Research, The Norwegian Radium Hospital, Oslo University Hospital, Norway.'}, {'ForeName': 'Vessela N', 'Initials': 'VN', 'LastName': 'Kristensen', 'Affiliation': 'Department of Cancer Genetics, Institute for Cancer Research, The Norwegian Radium Hospital, Oslo University Hospital, Norway.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Nebdal', 'Affiliation': 'Department of Cancer Genetics, Institute for Cancer Research, The Norwegian Radium Hospital, Oslo University Hospital, Norway.'}, {'ForeName': 'Anne-Lise', 'Initials': 'AL', 'LastName': 'Børresen-Dale', 'Affiliation': 'Department of Cancer Genetics, Institute for Cancer Research, The Norwegian Radium Hospital, Oslo University Hospital, Norway.'}, {'ForeName': 'Ole Christian', 'Initials': 'OC', 'LastName': 'Lingjaerde', 'Affiliation': 'Department of Cancer Genetics, Institute for Cancer Research, The Norwegian Radium Hospital, Oslo University Hospital, Norway.'}, {'ForeName': 'Olav', 'Initials': 'O', 'LastName': 'Engebraaten', 'Affiliation': 'Department of Tumor biology, Institute for Cancer Research, The Norwegian Radium Hospital, Oslo University Hospital, Norway.'}]",Molecular oncology,['10.1002/1878-0261.12561'] 1413,23681403,Cognitive function in older women with breast cancer treated with standard chemotherapy and capecitabine on Cancer and Leukemia Group B 49907.,"Cognitive changes in older women receiving chemotherapy are poorly understood. We examined self-reported cognitive function for older women who received adjuvant chemotherapy on Cancer and Leukemia Group B (CALGB) 49907. CALGB 49907 randomized 633 women aged ≥65 with stage I-III breast cancer to standard adjuvant chemotherapy (cyclophosphamide-methotrexate-5-fluorouracil or doxorubicin-cyclophosphamide) versus capecitabine. We examined self-reported cognitive function in 297 women (CALGB 361002) who enrolled on the quality of life substudy and had no gross impairment on cognitive screening. Women were evaluated using an 18-item instrument at six time points (baseline through 24 months). At each time point for each patient, we calculated a cognitive function score (CFS) defined as the mean response of items 1-18 and defined impairment as a score >1.5 standard deviations above the overall average baseline score. Differences in scores by patient characteristics were evaluated using a Kruskal-Wallis test. A linear mixed-effects model was used to assess CFSs by treatment over time. Among 297 women, the median age was 71.5 (range 65-85) and 73 % had performance status of 0. Baseline depression and fatigue were reported in 6 and 14 % of patients, respectively. The average CFS at baseline was 2.08 (corresponding to ""normal ability""), and baseline cognitive function did not differ by treatment regimen (p = 0.350). Over 24 months, women reported minimal changes at each time point and insignificant differences by treatment arm were observed. In a healthy group of older women, chemotherapy was not associated with longitudinal changes in self-reported cognitive function.",2013,"Over 24 months, women reported minimal changes at each time point and insignificant differences by treatment arm were observed.","['CALGB 49907 randomized 633 women aged ≥65 with stage I-III breast cancer to', 'older women who received adjuvant chemotherapy on Cancer and Leukemia Group B (CALGB) 49907', 'older women with breast cancer treated with', 'on Cancer and Leukemia Group B 49907', '297 women, the median age was 71.5 (range 65-85) and 73 % had performance status of 0', 'older women receiving', '297 women (CALGB 361002) who enrolled on the quality of life substudy and had no gross impairment on cognitive screening']","['capecitabine', 'standard adjuvant chemotherapy (cyclophosphamide-methotrexate-5-fluorouracil or doxorubicin-cyclophosphamide', 'standard chemotherapy and capecitabine', 'chemotherapy']","['Cognitive changes', 'Cognitive function', 'Baseline depression and fatigue', 'cognitive function score (CFS', 'baseline cognitive function', 'average CFS']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1 (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0023418', 'cui_str': 'Leucocythaemia'}, {'cui': 'C0441836', 'cui_str': 'Group B (qualifier value)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0034380'}, {'cui': 'C0439806', 'cui_str': 'Gross (qualifier value)'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}]","[{'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",633.0,0.0315417,"Over 24 months, women reported minimal changes at each time point and insignificant differences by treatment arm were observed.","[{'ForeName': 'Rachel A', 'Initials': 'RA', 'LastName': 'Freedman', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA 02215, USA. rafreedman@partners.org'}, {'ForeName': 'Brandelyn', 'Initials': 'B', 'LastName': 'Pitcher', 'Affiliation': ''}, {'ForeName': 'Nancy L', 'Initials': 'NL', 'LastName': 'Keating', 'Affiliation': ''}, {'ForeName': 'Karla V', 'Initials': 'KV', 'LastName': 'Ballman', 'Affiliation': ''}, {'ForeName': 'Jeanne', 'Initials': 'J', 'LastName': 'Mandelblatt', 'Affiliation': ''}, {'ForeName': 'Alice B', 'Initials': 'AB', 'LastName': 'Kornblith', 'Affiliation': ''}, {'ForeName': 'Gretchen G', 'Initials': 'GG', 'LastName': 'Kimmick', 'Affiliation': ''}, {'ForeName': 'Arti', 'Initials': 'A', 'LastName': 'Hurria', 'Affiliation': ''}, {'ForeName': 'Eric P', 'Initials': 'EP', 'LastName': 'Winer', 'Affiliation': ''}, {'ForeName': 'Clifford A', 'Initials': 'CA', 'LastName': 'Hudis', 'Affiliation': ''}, {'ForeName': 'Harvey Jay', 'Initials': 'HJ', 'LastName': 'Cohen', 'Affiliation': ''}, {'ForeName': 'Hyman B', 'Initials': 'HB', 'LastName': 'Muss', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Breast cancer research and treatment,['10.1007/s10549-013-2562-6'] 1414,32492920,"Comparisons between Manual Lymph Drainage, Abdominal Massage, and Electrical Stimulation on Functional Constipation Outcomes: A Randomized, Controlled Trial.","BACKGROUND Evidence supports abdominal massage (AM) or electrical stimulation (ES) as effective in treating functional constipation (FC). Manual lymph drainage (MLD) may also be beneficial, however, it was not previously investigated or compared to ES and AM. METHODS Sixteen college-aged males and 36 females were recruited. Participants were randomly assigned to MLD, AM or ES. Heart rate variability (HRV) measures for total power (TP), high frequency (HF), low frequency and LF/HF ratio assessed ANS outcomes. state-trait anxiety inventory (STAI) and stress response inventory (SRI) assessed psychological factors and bowel movement frequency (BMF) and duration (BMD) were recorded daily. RESULTS MLD significantly improved all ANS measures (p≤0.01); AM significantly improved LF, HF and LF/HF ratios (p = 0.04); and ES significantly improved LF (p = 0.1). STAI measures improved, but not significantly in all groups. SRI improved significantly from MLD (p < 0.01), AM (p = 0.04) and ES (p < 0.01), but changes were not significant between groups. BMD improved significantly in all groups (p≤ 0.02). BMF improved significantly only following MLD and AM (p < 0.1), but differences between groups were not significant (p = 0.39). CONCLUSIONS MLD significantly reduced FC symptoms and MLD had greater improvements than AM or ES.",2020,"RESULTS MLD significantly improved all ANS measures (p≤0.01); AM significantly improved LF, HF and LF/HF ratios (p = 0.04); and ES significantly improved LF (p = 0.1).",['Sixteen college-aged males and 36 females were recruited'],"['Manual Lymph Drainage, Abdominal Massage, and Electrical Stimulation', 'MLD, AM or ES', 'Manual lymph drainage (MLD', 'abdominal massage (AM) or electrical stimulation (ES']","['SRI', 'Functional Constipation Outcomes', 'FC symptoms and MLD', 'BMF', 'Heart rate variability (HRV) measures for total power (TP), high frequency (HF), low frequency and LF/HF ratio assessed ANS outcomes', 'STAI measures', 'BMD', 'LF, HF and LF/HF ratios', 'state-trait anxiety inventory (STAI) and stress response inventory (SRI) assessed psychological factors and bowel movement frequency (BMF) and duration (BMD']","[{'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0556834', 'cui_str': 'Manual lymphatic drainage'}, {'cui': 'C2316341', 'cui_str': 'Massage of abdomen'}, {'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}]","[{'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0401146', 'cui_str': 'Constipation - functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0556834', 'cui_str': 'Manual lymphatic drainage'}, {'cui': 'C0426642', 'cui_str': 'Frequency of bowel action'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205212', 'cui_str': 'High frequency'}, {'cui': 'C0205213', 'cui_str': 'Low frequency'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0683457', 'cui_str': 'State-trait anger expression inventory'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0033898', 'cui_str': 'Factors, Psychological'}, {'cui': 'C0449238', 'cui_str': 'Duration'}]",36.0,0.135208,"RESULTS MLD significantly improved all ANS measures (p≤0.01); AM significantly improved LF, HF and LF/HF ratios (p = 0.04); and ES significantly improved LF (p = 0.1).","[{'ForeName': 'Jacqueline S', 'Initials': 'JS', 'LastName': 'Drouin', 'Affiliation': 'School of Health Sciences, Oakland University, 433 Meadow Brook Road, Rochester, MI 48309-4451, USA.'}, {'ForeName': 'Lucinda', 'Initials': 'L', 'LastName': 'Pfalzer', 'Affiliation': 'Physical Therapy Department, University of Michigan-Flint, 2157 WSW Bldg., Flint, MI 48502-195, USA.'}, {'ForeName': 'Jung Myo', 'Initials': 'JM', 'LastName': 'Shim', 'Affiliation': 'Department of Skin and Health Care, Suseong University, 15 Dalgubeol-daero 528-gil, Suseong-gu, Daegu 13557, Korea.'}, {'ForeName': 'Seong Jung', 'Initials': 'SJ', 'LastName': 'Kim', 'Affiliation': 'Department of Physical Therapy, College of Health and Science, Kangwon National University, 346, Hwangjo-gil, Dogye-eup, Samcheok-si, Gangwon-do 24341, Korea.'}]",International journal of environmental research and public health,['10.3390/ijerph17113924'] 1415,32421440,Implementation of Minimally Invasive Esophagectomy From a Randomized Controlled Trial Setting to National Practice.,"PURPOSE The aim of this study was to examine the external validity of the randomized TIME trial, when minimally invasive esophagectomy (MIE) was implemented nationally in the Netherlands, using data from the Dutch Upper GI Cancer Audit (DUCA) for transthoracic esophagectomy. METHODS Original patient data from the TIME trial were extracted along with data from the DUCA dataset (2011-2017). Multivariate analysis, with adjustment for patient factors, tumor factors, and year of surgery, was performed for the effect of MIE versus open esophagectomy on clinical outcomes. RESULTS One hundred fifteen patients from the TIME trial (59 MIE v 56 open) and 4,605 patients from the DUCA dataset (2,652 MIE v 1,953 open) were included. In the TIME trial, univariate analysis showed that MIE reduced pulmonary complications and length of hospital stay. On the contrary, in the DUCA dataset, MIE was associated with increased total and pulmonary complications and reoperations; however, benefits included increased proportion of R0 margin and lymph nodes harvested, and reduced 30-day mortality. Multivariate analysis from the TIME trial showed that MIE reduced pulmonary complications (odds ratio [OR], 0.19; 95% CI, 0.06 to 0.61). In the DUCA dataset, MIE was associated with increased total complications (OR, 1.36; 95% CI, 1.19 to 1.57), pulmonary complications (OR, 1.50; 95% CI, 1.29 to 1.74), reoperations (OR, 1.74; 95% CI, 1.42 to 2.14), and length of hospital stay. Multivariate analysis of the combined and MIE datasets showed that inclusion in the TIME trial was associated with a reduction in reoperations, Clavien-Dindo grade > 1 complications, and length of hospital stay. CONCLUSION When adopted nationally outside the TIME trial, MIE was associated with an increase in total and pulmonary complications and reoperation rate. This may reflect nonexpert surgeons outside of high-volume centers performing this minimally invasive technique in a nonstandardized fashion outside of a controlled environment.",2020,"Multivariate analysis from the TIME trial showed that MIE reduced pulmonary complications (odds ratio [OR], 0.19; 95% CI, 0.06 to 0.61).","['Original patient data from the TIME trial were extracted along with data from the DUCA dataset (2011-2017', 'One hundred fifteen patients from the TIME trial (59 MIE v 56 open) and 4,605 patients from the DUCA dataset ']","['MIE versus open esophagectomy', 'Minimally Invasive Esophagectomy', 'minimally invasive esophagectomy (MIE']","['total complications', 'total and pulmonary complications and reoperation rate', 'pulmonary complications', 'pulmonary complications and length of hospital stay', 'length of hospital stay', 'reoperations, Clavien-Dindo grade > 1 complications, and length of hospital stay', '30-day mortality', 'total and pulmonary complications and reoperations', 'MIE reduced pulmonary complications']","[{'cui': 'C0205313', 'cui_str': 'Original'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0013331', 'cui_str': 'Dutch'}, {'cui': 'C0203057', 'cui_str': 'Upper gastrointestinal tract series'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0450985', 'cui_str': 'Alcohol use disorders identification test'}, {'cui': 'C0150098', 'cui_str': 'Data Set'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0085198', 'cui_str': 'Esophagectomy'}, {'cui': 'C0175566', 'cui_str': 'Open'}]","[{'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0085198', 'cui_str': 'Esophagectomy'}, {'cui': 'C0175566', 'cui_str': 'Open'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0035110', 'cui_str': 'Reoperation'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C4280965', 'cui_str': 'Greater than one'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0085198', 'cui_str': 'Esophagectomy'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}]",115.0,0.249686,"Multivariate analysis from the TIME trial showed that MIE reduced pulmonary complications (odds ratio [OR], 0.19; 95% CI, 0.06 to 0.61).","[{'ForeName': 'Sheraz R', 'Initials': 'SR', 'LastName': 'Markar', 'Affiliation': 'Department Surgery and Cancer, Imperial College London, London, United Kingdom.'}, {'ForeName': 'Melody', 'Initials': 'M', 'LastName': 'Ni', 'Affiliation': 'Department Surgery and Cancer, Imperial College London, London, United Kingdom.'}, {'ForeName': 'Suzanne S', 'Initials': 'SS', 'LastName': 'Gisbertz', 'Affiliation': 'Department of Surgery, Amsterdam University Medical Centers, University of Amsterdam, Cancer Center Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Leonie', 'Initials': 'L', 'LastName': 'van der Werf', 'Affiliation': 'Department of Surgery, Amsterdam University Medical Centers, University of Amsterdam, Cancer Center Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Straatman', 'Affiliation': 'Department of Surgery, Amsterdam University Medical Centers, Vrije Universiteit Amsterdam, Cancer Center Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Donald', 'Initials': 'D', 'LastName': 'van der Peet', 'Affiliation': 'Department of Surgery, Amsterdam University Medical Centers, Vrije Universiteit Amsterdam, Cancer Center Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Miguel A', 'Initials': 'MA', 'LastName': 'Cuesta', 'Affiliation': 'Department of Surgery, Amsterdam University Medical Centers, Vrije Universiteit Amsterdam, Cancer Center Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'George B', 'Initials': 'GB', 'LastName': 'Hanna', 'Affiliation': 'Department Surgery and Cancer, Imperial College London, London, United Kingdom.'}, {'ForeName': 'Mark I', 'Initials': 'MI', 'LastName': 'van Berge Henegouwen', 'Affiliation': 'Department of Surgery, Amsterdam University Medical Centers, University of Amsterdam, Cancer Center Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.02483'] 1416,31714584,The economic research of arsenic trioxide for the treatment of newly diagnosed acute promyelocytic leukemia in China.,"BACKGROUND The objective of this study was to conduct the first systematic evaluation of the long-term economic impact of arsenic trioxide (ATO) plus all-trans retinoic acid (ATRA) for the treatment of patients with newly diagnosed acute promyelocytic leukemia (APL) from the perspective of the Chinese health care system. METHODS On the basis of clinical data from a randomized phase 3 trial, a time-dependent Markov model with 4 health states (complete remission, relapse or treatment failure, post-treatment failure, and death) was used to evaluate the incremental costs per quality-adjusted life-year (QALY) gained from the ATO plus ATRA regimen compared with the ATRA plus chemotherapy (CT) regimen over a 30-year period. All costs were adjusted to 2018 levels based on the Chinese Consumer Price Index. Both costs and health outcomes were discounted by 3% annually. One-way sensitivity analysis and probability sensitivity analysis were performed. RESULTS Compared with the ATRA plus CT strategy, the ATO plus ATRA strategy was associated with 1.38 additional QALYs gained and $392.05 (estimated in 2018 US dollars) in incremental costs per patient over 30 years. Consequently, the incremental cost-effectiveness ratio was $284.02 per QALY gained, which was far below the Chinese willingness-to-pay threshold of $29,306 per QALY gained. Sensitivity analyses demonstrated the robustness of these results. CONCLUSIONS From the perspective of the Chinese health care system, the ATO plus ATRA strategy is cost-effective for patients with newly diagnosed APL compared with the ATRA plus CT strategy. Therefore, the authors strongly suggest that China's health authorities choose the former strategy for these patients, whether for the elderly or for young people.",2020,"Compared with the ATRA plus CT strategy, the ATO plus ATRA strategy was associated with 1.38 additional QALYs gained and $392.05 (estimated in 2018 US dollars) in incremental costs per patient over 30 years.","['patients with newly diagnosed acute promyelocytic leukemia (APL) from the perspective of the Chinese health care system', 'newly diagnosed acute promyelocytic leukemia in China', 'patients with newly diagnosed APL']","['ATRA plus CT', 'ATRA plus chemotherapy (CT', 'arsenic trioxide', 'arsenic trioxide (ATO) plus all-trans retinoic acid (ATRA']","['incremental cost-effectiveness ratio', 'costs and health outcomes']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0023487', 'cui_str': 'Myeloid Leukemia, Acute, M3'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0018696', 'cui_str': 'Health Care Systems'}, {'cui': 'C0008115', 'cui_str': 'Mainland China'}]","[{'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0052416', 'cui_str': 'arsenic trioxide'}, {'cui': 'C0040845', 'cui_str': 'retinoic acid'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",,0.0820965,"Compared with the ATRA plus CT strategy, the ATO plus ATRA strategy was associated with 1.38 additional QALYs gained and $392.05 (estimated in 2018 US dollars) in incremental costs per patient over 30 years.","[{'ForeName': 'Xichuang', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': ""Department of Pharmacy, Wuxi Ninth People's Hospital Affiliated to Soochow University and Wuxi Orthopedic Hospital, Wuxi, Jiangsu, China.""}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Hong', 'Affiliation': ""Department of Pharmacy, Wuxi Children's Hospital, Wuxi, Jiangsu, China.""}, {'ForeName': 'Panpan', 'Initials': 'P', 'LastName': 'Zheng', 'Affiliation': 'Department of Pharmacy, Ningbo No. 6 Hospital, Ningbo, Zhejiang, China.'}, {'ForeName': 'Xiaohong', 'Initials': 'X', 'LastName': 'You', 'Affiliation': ""Department of Pharmacy, Wuxi Ninth People's Hospital Affiliated to Soochow University and Wuxi Orthopedic Hospital, Wuxi, Jiangsu, China.""}, {'ForeName': 'Jinhua', 'Initials': 'J', 'LastName': 'Feng', 'Affiliation': ""Department of Pharmacy, Wuxi Ninth People's Hospital Affiliated to Soochow University and Wuxi Orthopedic Hospital, Wuxi, Jiangsu, China.""}, {'ForeName': 'Zhihu', 'Initials': 'Z', 'LastName': 'Huang', 'Affiliation': ""Department of Oncology, Wuxi Ninth People's Hospital Affiliated to Soochow University and Wuxi Orthopedic Hospital, Wuxi, Jiangsu, China.""}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ""Department of Pharmacy, Wuxi Children's Hospital, Wuxi, Jiangsu, China.""}]",Cancer,['10.1002/cncr.32519'] 1417,31996174,Study protocol of a randomised clinical trial testing whether metacognitive training can improve insight and clinical outcomes in schizophrenia.,"BACKGROUND Although insight in schizophrenia spectrum disorders (SSD) has been associated with positive outcomes, the effect size of previous treatments on insight has been relatively small to date. The metacognitive basis of insight suggests that metacognitive training (MCT) may improve insight and clinical outcomes in SSD, although this remains to be established. METHODS This single-center, assessor-blind, parallel-group, randomised clinical trial (RCT) aims to investigate the efficacy of MCT for improving insight (primary outcome), including clinical and cognitive insight, which will be measured by the Schedule for Assessment of Insight (Expanded version) (SAI-E) and the Beck Cognitive Scale (BCIS), respectively, in (at least) n = 126 outpatients with SSD at three points in time: i) at baseline (T0); ii) after treatment (T1) and iii) at 1-year follow-up (T2). SSD patients receiving MCT and controls attending a non-intervention support group will be compared on insight level changes and several clinical and cognitive secondary outcomes at T1 and T2, whilst adjusting for baseline data. Ecological momentary assessment (EMA) will be piloted to assess functioning in a subsample of participants. DISCUSSION To the best of our knowledge, this will be the first RCT testing the effect of group MCT on multiple insight dimensions (as primary outcome) in a sample of unselected patients with SSD, including several secondary outcomes of clinical relevance, namely symptom severity, functioning, which will also be evaluated with EMA, hospitalizations and suicidal behaviour. TRIAL REGISTRATION ClinicalTrials.gov: NCT04104347. Date of registration: 26/09/2019 (Retrospectively registered).",2020,"SSD patients receiving MCT and controls attending a non-intervention support group will be compared on insight level changes and several clinical and cognitive secondary outcomes at T1 and T2, whilst adjusting for baseline data.","['schizophrenia spectrum disorders (SSD', 'SSD patients receiving', 'schizophrenia', 'n\u2009=\u2009126 outpatients with SSD']","['MCT', 'Ecological momentary assessment (EMA', 'metacognitive training (MCT', 'metacognitive training']",['Assessment of Insight (Expanded version) (SAI-E) and the Beck Cognitive Scale (BCIS'],"[{'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0723179', 'cui_str': 'SSD'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}]","[{'cui': 'C1173173', 'cui_str': 'N-methanocarbathymidine'}, {'cui': 'C4277684', 'cui_str': 'Ecological Momentary Assessment'}, {'cui': 'C0268596', 'cui_str': 'Glutaric Acidemia, Type 2'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0233820', 'cui_str': 'Self-understanding'}, {'cui': 'C0205229', 'cui_str': 'Expanding (qualifier value)'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C0222045'}]",126.0,0.244999,"SSD patients receiving MCT and controls attending a non-intervention support group will be compared on insight level changes and several clinical and cognitive secondary outcomes at T1 and T2, whilst adjusting for baseline data.","[{'ForeName': 'Javier-David', 'Initials': 'JD', 'LastName': 'Lopez-Morinigo', 'Affiliation': 'Departamento de Psiquiatría, IIS-Fundación Jiménez Díaz, Madrid, Spain. javierd.lopez@uam.es.'}, {'ForeName': 'Verónica González', 'Initials': 'VG', 'LastName': 'Ruiz-Ruano', 'Affiliation': 'Departamento de Psiquiatría, IIS-Fundación Jiménez Díaz, Madrid, Spain.'}, {'ForeName': 'Adela Sánchez Escribano', 'Initials': 'ASE', 'LastName': 'Martínez', 'Affiliation': 'Departamento de Psiquiatría, IIS-Fundación Jiménez Díaz, Madrid, Spain.'}, {'ForeName': 'María Luisa Barrigón', 'Initials': 'MLB', 'LastName': 'Estévez', 'Affiliation': 'Departamento de Psiquiatría, IIS-Fundación Jiménez Díaz, Madrid, Spain.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Mata-Iturralde', 'Affiliation': 'Departamento de Psiquiatría, IIS-Fundación Jiménez Díaz, Madrid, Spain.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Muñoz-Lorenzo', 'Affiliation': 'Departamento de Psiquiatría, IIS-Fundación Jiménez Díaz, Madrid, Spain.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Sánchez-Alonso', 'Affiliation': 'Departamento de Psiquiatría, IIS-Fundación Jiménez Díaz, Madrid, Spain.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Artés-Rodríguez', 'Affiliation': 'Departamento de Teoría de Señal y de la Comunicación, Universidad Carlos III, Madrid, Spain.'}, {'ForeName': 'Anthony S', 'Initials': 'AS', 'LastName': 'David', 'Affiliation': 'Institute of Mental Health, University College London, London, UK.'}, {'ForeName': 'Enrique', 'Initials': 'E', 'LastName': 'Baca-García', 'Affiliation': 'Departamento de Psiquiatría, IIS-Fundación Jiménez Díaz, Madrid, Spain.'}]",BMC psychiatry,['10.1186/s12888-020-2431-x'] 1418,22168590,Liberal or restrictive transfusion in high-risk patients after hip surgery.,"BACKGROUND The hemoglobin threshold at which postoperative red-cell transfusion is warranted is controversial. We conducted a randomized trial to determine whether a higher threshold for blood transfusion would improve recovery in patients who had undergone surgery for hip fracture. METHODS We enrolled 2016 patients who were 50 years of age or older, who had either a history of or risk factors for cardiovascular disease, and whose hemoglobin level was below 10 g per deciliter after hip-fracture surgery. We randomly assigned patients to a liberal transfusion strategy (a hemoglobin threshold of 10 g per deciliter) or a restrictive transfusion strategy (symptoms of anemia or at physician discretion for a hemoglobin level of <8 g per deciliter). The primary outcome was death or an inability to walk across a room without human assistance on 60-day follow-up. RESULTS A median of 2 units of red cells were transfused in the liberal-strategy group and none in the restrictive-strategy group. The rates of the primary outcome were 35.2% in the liberal-strategy group and 34.7% in the restrictive-strategy group (odds ratio in the liberal-strategy group, 1.01; 95% confidence interval [CI], 0.84 to 1.22), for an absolute risk difference of 0.5 percentage points (95% CI, -3.7 to 4.7). The rates of in-hospital acute coronary syndrome or death were 4.3% and 5.2%, respectively (absolute risk difference, -0.9%; 99% CI, -3.3 to 1.6), and rates of death on 60-day follow-up were 7.6% and 6.6%, respectively (absolute risk difference, 1.0%; 99% CI, -1.9 to 4.0). The rates of other complications were similar in the two groups. CONCLUSIONS A liberal transfusion strategy, as compared with a restrictive strategy, did not reduce rates of death or inability to walk independently on 60-day follow-up or reduce in-hospital morbidity in elderly patients at high cardiovascular risk. (Funded by the National Heart, Lung, and Blood Institute; FOCUS ClinicalTrials.gov number, NCT00071032.).",2011,"The primary outcome was death or an inability to walk across a room without human assistance on 60-day follow-up. ","['2016 patients who were 50 years of age or older, who had either a history of or risk factors for cardiovascular disease, and whose hemoglobin level was below 10 g per deciliter after hip-fracture surgery', 'high-risk patients after hip surgery', 'elderly patients at high cardiovascular risk', 'patients who had undergone surgery for hip fracture']","['liberal transfusion strategy (a hemoglobin threshold of 10 g per deciliter) or a restrictive transfusion strategy (symptoms of anemia or at physician discretion', 'Liberal or restrictive transfusion']","['death or an inability to walk across a room without human assistance on 60-day follow-up', 'rates of death', 'rates of other complications', 'rates of in-hospital acute coronary syndrome or death']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1318182', 'cui_str': '10G'}, {'cui': 'C0439241', 'cui_str': 'dL'}, {'cui': 'C0019557', 'cui_str': 'Hip Fractures'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0596706', 'cui_str': 'Hip surgery'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}]","[{'cui': 'C0199960', 'cui_str': 'Transfusion - action (qualifier value)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0449864', 'cui_str': 'Threshold (property) (qualifier value)'}, {'cui': 'C1318182', 'cui_str': '10G'}, {'cui': 'C0439241', 'cui_str': 'dL'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0948089', 'cui_str': 'Acute Coronary Syndrome'}]",2016.0,0.298295,"The primary outcome was death or an inability to walk across a room without human assistance on 60-day follow-up. ","[{'ForeName': 'Jeffrey L', 'Initials': 'JL', 'LastName': 'Carson', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, University of Medicine and Dentistry of New Jersey, Robert Wood Johnson Medical School, New Brunswick, NJ 08903, USA. carson@umdnj.edu'}, {'ForeName': 'Michael L', 'Initials': 'ML', 'LastName': 'Terrin', 'Affiliation': ''}, {'ForeName': 'Helaine', 'Initials': 'H', 'LastName': 'Noveck', 'Affiliation': ''}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Sanders', 'Affiliation': ''}, {'ForeName': 'Bernard R', 'Initials': 'BR', 'LastName': 'Chaitman', 'Affiliation': ''}, {'ForeName': 'George G', 'Initials': 'GG', 'LastName': 'Rhoads', 'Affiliation': ''}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Nemo', 'Affiliation': ''}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Dragert', 'Affiliation': ''}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Beaupre', 'Affiliation': ''}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Hildebrand', 'Affiliation': ''}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Macaulay', 'Affiliation': ''}, {'ForeName': 'Courtland', 'Initials': 'C', 'LastName': 'Lewis', 'Affiliation': ''}, {'ForeName': 'Donald Richard', 'Initials': 'DR', 'LastName': 'Cook', 'Affiliation': ''}, {'ForeName': 'Gwendolyn', 'Initials': 'G', 'LastName': 'Dobbin', 'Affiliation': ''}, {'ForeName': 'Khwaja J', 'Initials': 'KJ', 'LastName': 'Zakriya', 'Affiliation': ''}, {'ForeName': 'Fred S', 'Initials': 'FS', 'LastName': 'Apple', 'Affiliation': ''}, {'ForeName': 'Rebecca A', 'Initials': 'RA', 'LastName': 'Horney', 'Affiliation': ''}, {'ForeName': 'Jay', 'Initials': 'J', 'LastName': 'Magaziner', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa1012452'] 1419,31485338,Pediatric-Oncology Simulation Training for Resident Education.,"Introduction We sought to evaluate pediatric oncology simulations intended to improve pediatric residents' skills and comfort in caring for children with cancer. Method In a non-randomized trial, controls (the first three rotations) received a standard set of lectures, and the intervention arm received these lectures plus five simulation-training scenarios-fever/neutropenia, a new leukemia diagnosis, end-of-life care discussion, tumor lysis syndrome, and a mediastinal mass. All residents were tested after the rotation on the first three scenarios; management skills were evaluated independently by two raters. Before and after training, all residents completed an emotional-appraisal questionnaire evaluating each scenario as a perceived challenge or threat. Analysis of variance (ANOVA) measured differences by study arm in skills-checklist assessments and appraisals; repeated-measures ANOVA measured changes in emotional-appraisal scores. Results Forty-two residents (9 control, 33 intervention) participated. Inter-rater agreement for skills-checklist scores using average-measures intraclass correlation was high (0.847), and overall mean scores were significantly higher for the intervention than control group across both raters ( P = 0.005). For all residents, perceived challenge increased in the end-of-life simulation, and perceived threat decreased in all three test scenarios. The intervention group, regardless of training year, evaluated the teaching scenarios favorably and felt that challenging oncology situations were addressed, skills were enhanced, and the simulations should be offered to other residents. Conclusions It was feasible to introduce residents to difficult pediatric oncology scenarios using simulation. The intervention group performed more skills than controls when tested, and perceive threat declined in all residents after their pediatric oncology rotation.",2019,"The intervention group, regardless of training year, evaluated the teaching scenarios favorably and felt that challenging oncology situations were addressed, skills were enhanced, and the simulations should be offered to other residents. ",['children with cancer'],[],"['emotional-appraisal scores', 'overall mean scores']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}]",[],"[{'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",42.0,0.0315062,"The intervention group, regardless of training year, evaluated the teaching scenarios favorably and felt that challenging oncology situations were addressed, skills were enhanced, and the simulations should be offered to other residents. ","[{'ForeName': 'Gayle M', 'Initials': 'GM', 'LastName': 'Smink', 'Affiliation': 'Assistant Professor of Pediatrics, Penn State Milton S. Hershey Medical Center, Hershey, Pennsylvania, USA.'}, {'ForeName': 'Donna B', 'Initials': 'DB', 'LastName': 'Jeffe', 'Affiliation': 'Professor of Medicine and director of the Health Behavior, Communication, and Outreach Core, Department of Medicine, and director of the Medical Education Research Unit, Office of Education, Washington University School of Medicine, St. Louis, Missouri, USA.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Hayashi', 'Affiliation': 'Professor of Pediatrics, Division of Pediatric Hematology/Oncology, Department of Pediatrics, Washington University School of Medicine, St. Louis, Missouri, USA.'}, {'ForeName': 'Noor', 'Initials': 'N', 'LastName': 'Al-Hammadi', 'Affiliation': 'statistical data analyst, Division of Biostatistics, Washington University School of Medicine, St. Louis, Missouri, USA.'}, {'ForeName': 'James J', 'Initials': 'JJ', 'LastName': 'Fehr', 'Affiliation': ""Professor of Anesthesiology and Pediatrics, Departments of Anesthesiology and Pediatrics, Washington University School of Medicine, and medical director of the Saigh Pediatric Simulation Center at St. Louis Children's Hospital, St. Louis, Missouri, USA.""}]",BMJ simulation & technology enhanced learning,['10.1136/bmjstel-2018-000347'] 1420,21321086,"A phase II, multicenter, open-label randomized study of motesanib or bevacizumab in combination with paclitaxel and carboplatin for advanced nonsquamous non-small-cell lung cancer.","BACKGROUND This phase II study estimated the difference in objective response rate (ORR) among patients with advanced nonsquamous non-small-cell lung cancer (NSCLC) receiving paclitaxel-carboplatin (CP) plus motesanib or bevacizumab. PATIENTS AND METHODS Chemotherapy-naive patients (N = 186) were randomized 1:1:1 to receive CP plus motesanib 125 mg once daily (qd) (arm A), motesanib 75 mg twice daily (b.i.d.) 5 days on/2 days off (arm B), or bevacizumab 15 mg/kg every 3 weeks (q3w) (arm C). The primary end point was ORR (per RECIST). Other end points included progression-free survival (PFS), overall survival (OS), motesanib pharmacokinetics, and adverse events (AEs). RESULTS ORRs in the three arms were as follows: arm A, 30% (95% confidence interval 18% to 43%); arm B, 23% (13% to 36%); and arm C, 37% (25% to 50%). Median PFS in arm A was 7.7 months, arm B 5.8 months, and arm C 8.3 months; median OS for arm A was 14.0 months, arm B 12.8 months, and arm C 14.0 months. Incidence of AEs was greater in arms A and B than in arm C. More grade 5 AEs not attributable to disease progression occurred in arm B (n = 10) than in arms A (n = 4) and C (n = 4). Motesanib plasma C(max) and C(min) values were consistent with its pharmacokinetic properties observed in previous studies. CONCLUSIONS The efficacy of 125 mg qd motesanib or bevacizumab plus CP was estimated to be comparable. Toxicity was higher but manageable in both motesanib arms. Efficacy and tolerability of motesanib 125 mg qd plus CP in advanced nonsquamous NSCLC are being further investigated in a phase III study.",2011,Incidence of AEs was greater in arms A and B than in arm C. More grade 5 AEs not attributable to disease progression occurred in arm B (n = 10) than in arms A (n = 4) and C (n = 4).,"['advanced nonsquamous non-small-cell lung cancer', 'Chemotherapy-naive patients (N = 186', 'patients with advanced nonsquamous non-small-cell lung cancer (NSCLC) receiving']","['CP plus motesanib', 'bevacizumab', 'paclitaxel-carboplatin (CP) plus motesanib or bevacizumab', 'motesanib 125 mg qd plus CP', 'motesanib or bevacizumab', 'motesanib 75 mg twice daily (b.i.d', 'bevacizumab plus CP', 'paclitaxel and carboplatin']","['Motesanib plasma C(max) and C(min) values', 'ORR (per RECIST', 'progression-free survival (PFS), overall survival (OS), motesanib pharmacokinetics, and adverse events (AEs', 'objective response rate (ORR', 'Efficacy and tolerability', 'Median PFS', 'Incidence of AEs', 'disease progression', 'Toxicity']","[{'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C2347295', 'cui_str': 'motesanib'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C4319551', 'cui_str': 'One hundred and twenty-five'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}]","[{'cui': 'C2347295', 'cui_str': 'motesanib'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C1709926', 'cui_str': 'RECIST'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0242656', 'cui_str': 'Disease Progression'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}]",186.0,0.0755838,Incidence of AEs was greater in arms A and B than in arm C. More grade 5 AEs not attributable to disease progression occurred in arm B (n = 10) than in arms A (n = 4) and C (n = 4).,"[{'ForeName': 'G R', 'Initials': 'GR', 'LastName': 'Blumenschein', 'Affiliation': 'Department of Thoracic/Head and Neck Medical Oncology, The University of Texas M.D. Anderson Cancer Center, Houston. Electronic address: gblumens@mdanderson.org.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Kabbinavar', 'Affiliation': 'Department of Medicine, University of California Los Angeles Medical Center, Los Angeles; Hematology/Oncology, University of California Los Angeles Medical Center, Los Angeles; Translational Oncology Research International, Los Angeles, USA.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Menon', 'Affiliation': 'Department of Medical Oncology, Tata Memorial Center, Mumbai, India.'}, {'ForeName': 'T S K', 'Initials': 'TSK', 'LastName': 'Mok', 'Affiliation': 'Department of Clinical Oncology, The Chinese University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Stephenson', 'Affiliation': 'Cancer Center of the Carolinas, Greenville.'}, {'ForeName': 'J T', 'Initials': 'JT', 'LastName': 'Beck', 'Affiliation': 'Highlands Oncology Group, Fayetteville, USA.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Lakshmaiah', 'Affiliation': 'Department of Medical Oncology, Kidwai Memorial Institute of Oncology, Bangalore, India.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Reckamp', 'Affiliation': 'Department of Medical Oncology and Therapeutics Research, City of Hope Comprehensive Cancer Center, Duarte.'}, {'ForeName': 'Y-J', 'Initials': 'YJ', 'LastName': 'Hei', 'Affiliation': 'Department of Oncology.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Kracht', 'Affiliation': 'Biostatistics and Epidemiology.'}, {'ForeName': 'Y-N', 'Initials': 'YN', 'LastName': 'Sun', 'Affiliation': 'Pharmacokinetics and Drug Metabolism, Amgen Inc., Thousand Oaks.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Sikorski', 'Affiliation': 'Department of Oncology.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Schwartzberg', 'Affiliation': 'Department of Hematology and Oncology, The West Clinic, Memphis, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdq731'] 1421,20855467,Phase 3 study of docosahexaenoic acid-paclitaxel versus dacarbazine in patients with metastatic malignant melanoma.,"BACKGROUND Docosahexaenoic acid-paclitaxel (DHA-paclitaxel, Taxoprexin(®)) is made by covalently conjugating the essential fatty acid DHA to the paclitaxel molecule. Preclinical studies of DHA-paclitaxel have demonstrated increased activity relative to paclitaxel and the potential for an improved therapeutic ratio. In the present study, the efficacy and toxicity profiles of DHA-paclitaxel were compared with those of dacarbazine. METHODS In this study, 393 chemonaive patients with metastatic melanoma were randomly assigned to receive either DHA-paclitaxel at a starting dose of 900 mg/m(2) IV on day 1 every 3 weeks or dacarbazine at a starting dose of 1000 mg/m(2) IV on day 1 every 3 weeks. The primary end point of the study was the comparison of overall survival (OS). RESULTS No significant difference in OS was noted between patients in the DHA-paclitaxel and dacarbazine arms. Similarly, there were no significant differences in response rate, duration of response, time to progression, and time to treatment failure between the two drugs. Safety results of the two drugs were as predicted from prior studies. Myelosuppression was more common with DHA-paclitaxel. CONCLUSIONS DHA-paclitaxel was not superior to dacarbazine. We conclude that further studies with the drug on an every 3-week schedule in melanoma are not warranted.",2011,"Similarly, there were no significant differences in response rate, duration of response, time to progression, and time to treatment failure between the two drugs.","['patients with metastatic malignant melanoma', '393 chemonaive patients with metastatic melanoma']","['dacarbazine', 'Docosahexaenoic acid-paclitaxel (DHA-paclitaxel, Taxoprexin(®', 'docosahexaenoic acid-paclitaxel versus dacarbazine', 'DHA-paclitaxel']","['OS', 'Myelosuppression', 'efficacy and toxicity profiles', 'overall survival (OS', 'response rate, duration of response, time to progression, and time to treatment failure']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0860594', 'cui_str': 'Malignant melanoma, metastatic'}, {'cui': 'C4517754', 'cui_str': 'Three hundred and ninety-three'}, {'cui': 'C0278883', 'cui_str': 'Metastatic melanoma'}]","[{'cui': 'C0010927', 'cui_str': 'Dacarbazine'}, {'cui': 'C1134470', 'cui_str': 'DHA-paclitaxel'}, {'cui': 'C1135143', 'cui_str': 'Taxoprexin'}]","[{'cui': 'C0854467', 'cui_str': 'Myelosuppression (finding)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C3494202', 'cui_str': 'Time-to-Treatment'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}]",393.0,0.327994,"Similarly, there were no significant differences in response rate, duration of response, time to progression, and time to treatment failure between the two drugs.","[{'ForeName': 'A Y', 'Initials': 'AY', 'LastName': 'Bedikian', 'Affiliation': 'Department of Melanoma Medical Oncology, The University of Texas M. D. Anderson Cancer Center, Houston. Electronic address: abedikia@mdanderson.org.'}, {'ForeName': 'R C', 'Initials': 'RC', 'LastName': 'DeConti', 'Affiliation': 'Department of Cutaneous Oncology, H. Lee Moffitt Cancer Center & Research Institute, Tampa.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Conry', 'Affiliation': 'Division of Hematology & Oncology, Kirkland Clinic at Acton Road, Birmingham.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Agarwala', 'Affiliation': ""Department of Hematology/Oncology, St Luke's Cancer Center, Bethlehem.""}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Papadopoulos', 'Affiliation': 'Department of Melanoma Medical Oncology, The University of Texas M. D. Anderson Cancer Center, Houston.'}, {'ForeName': 'K B', 'Initials': 'KB', 'LastName': 'Kim', 'Affiliation': 'Department of Melanoma Medical Oncology, The University of Texas M. D. Anderson Cancer Center, Houston.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Ernstoff', 'Affiliation': 'Department of Hematology/Oncology, Dartmouth-Hitchcock Medical Center, Lebanon, USA.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdq438'] 1422,31869494,The effect of ventilation tube insertion on quality of life in children with persistent otitis media with effusion.,"OBJECTIVES To determine the effect of ventilation tube (VT) surgery on quality of life (QoL) in children with persistent otitis media with effusion (OME). DESIGN Secondary analysis of trial data (oral steroids versus placebo for persistent OME), comparing QoL by history of VT surgery performed between 5 weeks and 12 months post-randomisation. Multilevel regression models were used to identify the association between VT surgery and QoL scores at 12 months, controlling for pre-exposure risk factors associated with surgery, including pre-surgery hearing level. SETTING Ear, nose and throat (ENT), paediatric audiology and audiovestibular medicine (AVM) departments in Wales and England. PARTICIPANTS A total of 327 children aged 2-8 years with OME symptoms for at least three months and audiometry-proven bilateral hearing loss with VT surgery status. MAIN OUTCOME MEASURES Otitis Media questionnaire (OM8-30) and Paediatric Quality of Life Inventory (PedsQL) total and subscale scores, and the Health Utilities Index Mark 3 (HUI3) at 12 months post-randomisation. RESULTS Participants who had VT surgery had no significant difference in OM8-30, PedsQL or HUI total scores. OM8-30 hearing difficulty (HD) subscale scores at 12 months were better in those who had VT surgery (adjusted mean difference (aMD) = -0.46 (95% confidence interval: -0.69 to -0.23), P < .001), and this varied by when the surgery occurred (aMD for surgery between 5 weeks and 6 months = -0.4 [-0.67 to -0.13], P = .004 and between 6 and 12 months = -0.54, [-0.87 to -0.22], P = .001). CONCLUSION Ventilation tube surgery was associated with an improvement in HD-related functional health status but no change in overall QoL.",2020,"RESULTS Participants who had VT surgery had no significant difference in OM8-30, PedsQL or HUI total scores.","['Ear, nose and throat (ENT), paediatric audiology and audiovestibular medicine (AVM) departments in Wales and England', '327 children aged 2 to 8 years old with OME symptoms for at least three months and audiometry proven bilateral hearing loss with VT surgery status', 'children with persistent otitis media with effusion', 'children with persistent otitis media with effusion (OME']","['ventilation tube insertion', 'steroids versus placebo', 'ventilation tube (VT) surgery']","['VT surgery and QoL scores', 'OM8-30, PedsQL or HUI total scores', 'quality of life (QoL', 'HD related functional health status', 'quality of life', 'overall QoL', 'OM8-30 hearing difficulty (HD) subscale scores', 'Otitis Media questionnaire (OM8-30) and Paediatric Quality of Life Inventory (PedsQL) total and subscale scores, and the Health Utilities Index Mark 3 (HUI3']","[{'cui': 'C0150934', 'cui_str': 'Ear, nose and throat structure'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0004285', 'cui_str': 'Audiology'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C4082119', 'cui_str': 'Three months (qualifier value)'}, {'cui': 'C0004286', 'cui_str': 'Audiometry'}, {'cui': 'C0456369', 'cui_str': 'Proven (qualifier value)'}, {'cui': 'C0018775', 'cui_str': 'Hearing Loss, Bilateral'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0029883', 'cui_str': 'Otitis Media, Secretory'}]","[{'cui': 'C0850121', 'cui_str': 'Ventilation tube'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0038317', 'cui_str': 'Steroids'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0018759', 'cui_str': 'Level of Health'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0459443', 'cui_str': 'Subscale score (qualifier value)'}, {'cui': 'C0029882', 'cui_str': 'Middle Ear Inflammation'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0522501', 'cui_str': 'Massive (qualifier value)'}]",327.0,0.0881923,"RESULTS Participants who had VT surgery had no significant difference in OM8-30, PedsQL or HUI total scores.","[{'ForeName': 'Leigh N', 'Initials': 'LN', 'LastName': 'Sanyaolu', 'Affiliation': 'The Division of Population Medicine, Heath Park, Cardiff, UK.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Cannings-John', 'Affiliation': 'The Centre for Trials Research, Heath Park, Cardiff, UK.'}, {'ForeName': 'Christopher C', 'Initials': 'CC', 'LastName': 'Butler', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, Oxford, UK.'}, {'ForeName': 'Nick A', 'Initials': 'NA', 'LastName': 'Francis', 'Affiliation': 'The Division of Population Medicine, Heath Park, Cardiff, UK.'}]",Clinical otolaryngology : official journal of ENT-UK ; official journal of Netherlands Society for Oto-Rhino-Laryngology & Cervico-Facial Surgery,['10.1111/coa.13502'] 1423,20386463,Regulatory (FoxP3+) T-cell tumor infiltration is a favorable prognostic factor in advanced colon cancer patients undergoing chemo or chemoimmunotherapy.,"Antitumor immune response and chemotherapy-induced immunomodulation in colon cancer patients represented the rationale to design new strategies, like GOLFIG chemoimmunotherapy (gemcitabine, oxaliplatin, 5-fluorouracil/folinic acid, granulocyte macrophage colony-stimulating factor, and aldesleukine), that resulted a safe and very active regimen. Antitumor activity and immunity feedback to GOLFIG were strictly correlated with the best outcome observed in patients with autoimmunity signs, increase of central memory T cells, and decrease of regulatory T cells (Treg) in the peripheral blood. We thus investigated a potential correlation between the Treg tumor infiltration at diagnosis and the clinical outcome in a current randomized phase 3 trial aimed to compare the GOLFIG regimen with the standard FOLFOX chemotherapy (GOLFIG-2). An immunohistochemistry study was carried out to quantify the infiltration of Treg/FoxP3+ T lymphocytes in tumor samples of 57 patients enrolled in the GOLFIG-2 trial. Treg tumor infiltration scores were correlated with overall survival, treatment-relative survival, and progression-free survival (PFS). Higher Treg tumor infiltration scores were associated with a better prognosis in the whole series (Treg high score vs. low score: overall survival=mean 43.2 mo vs. 28.6 mo, P=0.0005) and a better outcome after treatment (Treg high score vs. low score: PFS=mean 15.8 mo vs. 8.8 mo, P=0.0009; treatment-relative survival=mean 23.1 mo vs. 18.2 mo, P=0.004). PFS was significantly longer in GOLFIG high versus all other subgroups (mean 18.1 mo vs. 9.9 mo, P=0.01). Our results suggest that a higher FoxP3+ T-lymphocyte tumor infiltration score is a favorable prognostic factor in colon cancer patients undergoing chemo or chemoimmunotherapy.",2010,"Treg tumor infiltration scores were correlated with overall survival, treatment-relative survival, and progression-free survival (PFS).","['colon cancer patients undergoing chemo or', 'colon cancer patients', 'advanced colon cancer patients undergoing chemo or', '57 patients enrolled in the GOLFIG-2 trial']","['GOLFIG chemoimmunotherapy (gemcitabine, oxaliplatin, 5-fluorouracil/folinic acid, granulocyte macrophage colony-stimulating factor, and aldesleukine', 'standard FOLFOX chemotherapy (GOLFIG-2', 'chemoimmunotherapy', 'Regulatory (FoxP3+) T-cell tumor infiltration', 'chemotherapy-induced immunomodulation']","['Higher Treg tumor infiltration scores', 'Treg tumor infiltration scores', 'PFS', 'central memory T cells, and decrease of regulatory T cells', 'overall survival, treatment-relative survival, and progression-free survival (PFS', 'Antitumor activity and immunity feedback']","[{'cui': 'C0007102', 'cui_str': 'Cancer of Colon'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}]","[{'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0023413', 'cui_str': 'Leucovorin'}, {'cui': 'C0079460', 'cui_str': 'Tumor-Cell Human GM Colony-Stimulating Factor'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0039194', 'cui_str': 'Thymus-Dependent Lymphocytes'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C3669041', 'cui_str': 'Spread by direct extension (qualifier value)'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C1963758', 'cui_str': 'Immunomodulatory Therapy'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C3669041', 'cui_str': 'Spread by direct extension (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0039194', 'cui_str': 'Thymus-Dependent Lymphocytes'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0039198', 'cui_str': 'T-Cells, Regulatory'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0020964', 'cui_str': 'Immunity'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}]",57.0,0.0477373,"Treg tumor infiltration scores were correlated with overall survival, treatment-relative survival, and progression-free survival (PFS).","[{'ForeName': 'Pierpaolo', 'Initials': 'P', 'LastName': 'Correale', 'Affiliation': 'Department Giorgio Segre of Pharmacology, Siena University School of Medicine, Italy.'}, {'ForeName': 'Maria Saveria', 'Initials': 'MS', 'LastName': 'Rotundo', 'Affiliation': ''}, {'ForeName': 'Maria Teresa', 'Initials': 'MT', 'LastName': 'Del Vecchio', 'Affiliation': ''}, {'ForeName': 'Cinzia', 'Initials': 'C', 'LastName': 'Remondo', 'Affiliation': ''}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Migali', 'Affiliation': ''}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Ginanneschi', 'Affiliation': ''}, {'ForeName': 'Kwong Y', 'Initials': 'KY', 'LastName': 'Tsang', 'Affiliation': ''}, {'ForeName': 'Antonella', 'Initials': 'A', 'LastName': 'Licchetta', 'Affiliation': ''}, {'ForeName': 'Susanna', 'Initials': 'S', 'LastName': 'Mannucci', 'Affiliation': ''}, {'ForeName': 'Lucia', 'Initials': 'L', 'LastName': 'Loiacono', 'Affiliation': ''}, {'ForeName': 'Pierfrancesco', 'Initials': 'P', 'LastName': 'Tassone', 'Affiliation': ''}, {'ForeName': 'Guido', 'Initials': 'G', 'LastName': 'Francini', 'Affiliation': ''}, {'ForeName': 'Pierosandro', 'Initials': 'P', 'LastName': 'Tagliaferri', 'Affiliation': ''}]","Journal of immunotherapy (Hagerstown, Md. : 1997)",['10.1097/CJI.0b013e3181d32f01'] 1424,31314050,Effect of Simvastatin-Ezetimibe Compared With Simvastatin Monotherapy After Acute Coronary Syndrome Among Patients 75 Years or Older: A Secondary Analysis of a Randomized Clinical Trial.,"Importance Limited evidence is available regarding the benefit and hazard of higher-intensity treatment to lower lipid levels among patients 75 years or older. As a result, guideline recommendations differ for this age group compared with younger patients. Objective To determine the effect on outcomes and risks of combination ezetimibe and simvastatin compared with simvastatin monotherapy to lower lipid levels among patients 75 years or older with stabilized acute coronary syndrome (ACS). Design, Setting, Participants In this prespecified secondary analysis of the global, multicenter, prospective clinical randomized Improved Reduction of Outcomes: Vytorin Efficacy International Trial (IMPROVE-IT), outcomes and risks were compared by age among patients 50 years or older after a hospitalization for ACS. Data were collected from October 26, 2005, through July 8, 2010, with the database locked October 21, 2014. Data were analyzed May 29, 2015, through March 13, 2018, using Kaplan-Meier curves and Cox proportional hazards models. Interventions Double-blind randomized assignment to combined simvastatin and ezetimibe or simvastatin and placebo with follow-up for a median of 6 years (interquartile range, 4.3-7.1 years). Main Outcomes and Measures The primary composite end point consisted of death due to cardiovascular disease, myocardial infarction (MI), stroke, unstable angina requiring hospitalization, and coronary revascularization after 30 days. Individual adverse ischemic and safety end points and lipid variables were also analyzed. Results Of 18 144 patients enrolled (13 728 men [75.7%]; mean [SD] age, 64.1 [9.8] years), 5173 (28.5%) were 65 to 74 years old, and 2798 (15.4%) were 75 years or older at randomization. Treatment with simvastatin-ezetimibe resulted in lower rates of the primary end point than simvastatin-placebo, including 0.9% for patients younger than 65 years (HR, 0.97; 95% CI, 0.90-1.05) and 0.8% for patients 65 to 74 years of age (hazard ratio [HR], 0.96; 95% CI, 0.87-1.06), with the greatest absolute risk reduction of 8.7% for patients 75 years or older (HR, 0.80; 95% CI, 0.70-0.90) (P = .02 for interaction). The rate of adverse events did not increase with simvastatin-ezetimibe vs simvastatin-placebo among younger or older patients. Conclusions and Relevance In IMPROVE-IT, patients hospitalized for ACS derived benefit from higher-intensity therapy to lower lipid levels with simvastatin-ezetimibe compared with simvastatin monotherapy, with the greatest absolute risk reduction among patients 75 years or older. Addition of ezetimibe to simvastatin was not associated with any significant increase in safety issues among older patients. These results may have implications for guideline recommendations regarding lowering of lipid levels in the elderly. Trial Registration ClinicalTrials.gov identifier: NCT00202878.",2019,"Treatment with simvastatin-ezetimibe resulted in lower rates of the primary end point than simvastatin-placebo, including 0.9% for patients younger than 65 years (HR, 0.97; 95% CI, 0.90-1.05) and 0.8% for patients 65 to 74 years of age (hazard ratio [HR], 0.96; 95% CI, 0.87-1.06), with the greatest absolute risk reduction of 8.7% for patients 75 years or older (HR, 0.80; 95% CI, 0.70-0.90) (P = .02 for interaction).","['patients 75 years or older', 'median of 6 years (interquartile range, 4.3-7.1 years', 'patients 75 years or older with stabilized acute coronary syndrome (ACS', 'patients 50 years or older after a hospitalization for ACS', 'Participants', 'older patients', 'Results\n\n\nOf 18\u202f144 patients enrolled (13 728 men [75.7%]; mean [SD] age, 64.1 [9.8] years), 5173 (28.5%) were 65 to 74 years old, and 2798 (15.4%) were 75 years or older at randomization', 'Data were collected from October 26, 2005, through July 8, 2010, with the database locked October 21, 2014', 'Patients 75 Years or Older', 'younger or older patients']","['Simvastatin-Ezetimibe', 'simvastatin-placebo', 'combination ezetimibe and simvastatin', 'simvastatin-ezetimibe', 'simvastatin-ezetimibe vs simvastatin-placebo', 'ezetimibe to simvastatin', 'simvastatin monotherapy', 'Simvastatin Monotherapy', 'combined simvastatin and ezetimibe or simvastatin and placebo']","['rate of adverse events', 'Individual adverse ischemic and safety end points and lipid variables', 'lipid levels', 'death due to cardiovascular disease, myocardial infarction (MI), stroke, unstable angina requiring hospitalization, and coronary revascularization']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C4517759', 'cui_str': 'Four point three'}, {'cui': 'C0184512', 'cui_str': 'Stabilized (qualifier value)'}, {'cui': 'C0948089', 'cui_str': 'Acute Coronary Syndrome'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517678', 'cui_str': '28.5'}, {'cui': 'C4517579', 'cui_str': '15.4 (qualifier value)'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}]","[{'cui': 'C0074554', 'cui_str': 'Simvastatin'}, {'cui': 'C1142985', 'cui_str': 'ezetimibe'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1532737', 'cui_str': 'ezetimibe / Simvastatin'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0475224', 'cui_str': 'Ischemic (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0428460', 'cui_str': 'Finding of lipid level (finding)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0002965', 'cui_str': 'Angina at Rest'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0877341', 'cui_str': 'Coronary revascularisation'}]",,0.259567,"Treatment with simvastatin-ezetimibe resulted in lower rates of the primary end point than simvastatin-placebo, including 0.9% for patients younger than 65 years (HR, 0.97; 95% CI, 0.90-1.05) and 0.8% for patients 65 to 74 years of age (hazard ratio [HR], 0.96; 95% CI, 0.87-1.06), with the greatest absolute risk reduction of 8.7% for patients 75 years or older (HR, 0.80; 95% CI, 0.70-0.90) (P = .02 for interaction).","[{'ForeName': 'Richard G', 'Initials': 'RG', 'LastName': 'Bach', 'Affiliation': 'Cardiovascular Division, Department of Medicine, Washington University School of Medicine, St Louis, Missouri.'}, {'ForeName': 'Christopher P', 'Initials': 'CP', 'LastName': 'Cannon', 'Affiliation': ""TIMI Study Group, Cardiovascular Division, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Robert P', 'Initials': 'RP', 'LastName': 'Giugliano', 'Affiliation': ""TIMI Study Group, Cardiovascular Division, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Jennifer A', 'Initials': 'JA', 'LastName': 'White', 'Affiliation': 'Duke Clinical Research Institute, Division of Cardiology, Department of Medicine, Duke University, Durham, North Carolina.'}, {'ForeName': 'Yuliya', 'Initials': 'Y', 'LastName': 'Lokhnygina', 'Affiliation': 'Duke Clinical Research Institute, Division of Cardiology, Department of Medicine, Duke University, Durham, North Carolina.'}, {'ForeName': 'Erin A', 'Initials': 'EA', 'LastName': 'Bohula', 'Affiliation': ""TIMI Study Group, Cardiovascular Division, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Califf', 'Affiliation': 'Duke Clinical Research Institute, Division of Cardiology, Department of Medicine, Duke University, Durham, North Carolina.'}, {'ForeName': 'Eugene', 'Initials': 'E', 'LastName': 'Braunwald', 'Affiliation': ""TIMI Study Group, Cardiovascular Division, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Blazing', 'Affiliation': 'Duke Clinical Research Institute, Division of Cardiology, Department of Medicine, Duke University, Durham, North Carolina.'}]",JAMA cardiology,['10.1001/jamacardio.2019.2306'] 1425,31356757,Call for Changes in Lung Allocation to Reduce Transplant Wait-List Mortality for Cystic Fibrosis.,,2019,,['Cystic Fibrosis'],[],[],"[{'cui': 'C0010674', 'cui_str': 'Mucoviscidosis'}]",[],[],,0.0158963,,"[{'ForeName': 'Eric P', 'Initials': 'EP', 'LastName': 'Nolley', 'Affiliation': 'Department of MedicineUniversity of PittsburghPittsburgh, Pennsylvania.'}, {'ForeName': 'Joseph M', 'Initials': 'JM', 'LastName': 'Pilewski', 'Affiliation': 'Department of MedicineUniversity of PittsburghPittsburgh, Pennsylvania.'}]",American journal of respiratory and critical care medicine,['10.1164/rccm.201907-1385ED'] 1426,32431211,Accurately Reflecting Uncertainty When Using Patient-Level Simulation Models to Extrapolate Clinical Trial Data.,"Introduction. Patient-level simulation models facilitate extrapolation of clinical trial data while allowing for heterogeneity, prior history, and nonlinearity. However, combining different types of uncertainty around within-trial and extrapolated results remains challenging. Methods. We tested 4 methods to combine parameter uncertainty (around the regression coefficients used to predict future events) with sampling uncertainty (uncertainty around mean risk factors within the finite sample whose outcomes are being predicted and the effect of treatment on these risk factors). We compared these 4 methods using a simulation study based on an economic evaluation extrapolating the AFORRD randomized controlled trial using the UK Prospective Diabetes Study Outcomes Model version 2. This established type 2 diabetes model predicts patient-level health outcomes and costs. Results. The 95% confidence intervals around life years gained gave 25% coverage when sampling uncertainty was excluded (i.e., 25% of 95% confidence intervals contained the ""true"" value). Allowing for sampling uncertainty as well as parameter uncertainty widened confidence intervals by 6.3-fold and gave 96.3% coverage. Methods adjusting for baseline risk factors that combine sampling and parameter uncertainty overcame the bias that can result from between-group baseline imbalance and gave confidence intervals around 50% wider than those just considering parameter uncertainty, with 99.8% coverage. Conclusions. Analyses extrapolating data for individual trial participants should include both sampling uncertainty and parameter uncertainty and should adjust for any imbalance in baseline covariates.",2020,"The 95% confidence intervals around life years gained gave 25% coverage when sampling uncertainty was excluded (i.e., 25% of 95% confidence intervals contained the ""true"" value).",[],[],[],[],[],[],,0.0800414,"The 95% confidence intervals around life years gained gave 25% coverage when sampling uncertainty was excluded (i.e., 25% of 95% confidence intervals contained the ""true"" value).","[{'ForeName': 'Helen A', 'Initials': 'HA', 'LastName': 'Dakin', 'Affiliation': 'Nuffield Department of Population, Health Economics Research Centre, University of Oxford, Oxford, Oxfordshire, UK.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Leal', 'Affiliation': 'Nuffield Department of Population, Health Economics Research Centre, University of Oxford, Oxford, Oxfordshire, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Briggs', 'Affiliation': 'Department of Health Services Research & Policy, London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Clarke', 'Affiliation': 'Nuffield Department of Population, Health Economics Research Centre, University of Oxford, Oxford, Oxfordshire, UK.'}, {'ForeName': 'Rury R', 'Initials': 'RR', 'LastName': 'Holman', 'Affiliation': 'Diabetes Trials Unit, University of Oxford, Oxford, Oxfordshire, UK.'}, {'ForeName': 'Alastair', 'Initials': 'A', 'LastName': 'Gray', 'Affiliation': 'Nuffield Department of Population, Health Economics Research Centre, University of Oxford, Oxford, Oxfordshire, UK.'}]",Medical decision making : an international journal of the Society for Medical Decision Making,['10.1177/0272989X20916442'] 1427,31525129,Effects of Consuming Almonds on Insulin Sensitivity and Other Cardiometabolic Health Markers in Adults With Prediabetes.,"Objective: This study was designed to assess the effects of replacing high-carbohydrate (CHO) foods with raw almonds on insulin sensitivity and cardiometabolic health markers in overweight or obese adults with prediabetes. Method: This randomized crossover study consisted of two 6-week dietary intervention periods, separated by a ≥ 4-week washout. Subjects incorporated 1.5 oz of raw almonds twice daily or isocaloric CHO-based foods into their diets, with instructions to maintain body weight. Dietary intakes as well as insulin sensitivity, CHO metabolism indices, lipoprotein lipids and particles, and inflammatory markers were assessed. Results: Thirty-three subjects (17 male, 16 female), mean age 48.3 ± 2.2 years and body mass index 30.5 ± 0.7 kg/m 2 , provided evaluable data. Compared to CHO, almonds resulted in significantly ( p  < 0.01) higher intakes of protein, fat (unsaturated fatty acids), fiber, and magnesium and significantly ( p  < 0.001) lower intakes of CHO and sugars. No differences were observed between diet conditions for changes from baseline in the insulin sensitivity index from a short intravenous glucose tolerance test or other indices of glucose homeostasis. No significant differences were observed in biomarkers of cardiovascular risk except that the CHO intervention led to a shift toward a higher concentration of cholesterol in small, dense low-density lipoprotein subfraction 3+4 (LDL3 + 4) particles ( p  = 0.024 vs almonds). Conclusions: Intake of 3.0 oz/d raw almonds, vs energy-matched CHO foods, improved the dietary nutrient profile, but did not significantly affect insulin sensitivity and most markers of cardiometabolic health in overweight and obese men and women with prediabetes.",2020,No differences were observed between diet conditions for changes from baseline in the insulin sensitivity index from a short intravenous glucose tolerance test or other indices of glucose homeostasis.,"['Adults With Prediabetes', 'overweight and obese men and women with prediabetes', 'Results: Thirty-three subjects (17 male, 16 female), mean age 48.3\u2009±\u20092.2\u2009years and body mass index 30.5\u2009±\u20090.7\u2009kg/m 2 , provided evaluable data', 'overweight or obese adults with prediabetes']","['isocaloric CHO-based foods into their diets', 'replacing high-carbohydrate (CHO) foods with raw almonds']","['insulin sensitivity', 'concentration of cholesterol in small, dense low-density lipoprotein subfraction', 'intakes of protein, fat (unsaturated fatty acids), fiber, and magnesium', 'cardiometabolic health', 'insulin sensitivity and cardiometabolic health markers', 'insulin sensitivity index', 'Insulin Sensitivity and Other Cardiometabolic Health Markers', 'biomarkers of cardiovascular risk', 'insulin sensitivity, CHO metabolism indices, lipoprotein lipids and particles, and inflammatory markers']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0362046', 'cui_str': 'Prediabetes'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0450358', 'cui_str': '33 (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517629', 'cui_str': '2.2'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517474', 'cui_str': '0.7 (qualifier value)'}]","[{'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0453803', 'cui_str': 'High carbohydrate food (substance)'}, {'cui': 'C0440286', 'cui_str': 'Almonds'}]","[{'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C0439794', 'cui_str': 'Dense (qualifier value)'}, {'cui': 'C0578543', 'cui_str': 'Low density lipoprotein subfraction (substance)'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0015684', 'cui_str': 'Fatty Acids'}, {'cui': 'C0225326', 'cui_str': 'Fiber'}, {'cui': 'C3540792', 'cui_str': 'Magnesium supplements, alimentary tract and metabolism'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0025520', 'cui_str': 'metabolism'}, {'cui': 'C0023820', 'cui_str': 'Circulating Lipoproteins'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}]",33.0,0.0492321,No differences were observed between diet conditions for changes from baseline in the insulin sensitivity index from a short intravenous glucose tolerance test or other indices of glucose homeostasis.,"[{'ForeName': 'Orsolya M', 'Initials': 'OM', 'LastName': 'Palacios', 'Affiliation': 'Midwest Biomedical Research, Addison, Illinois, USA.'}, {'ForeName': 'Kevin C', 'Initials': 'KC', 'LastName': 'Maki', 'Affiliation': 'Midwest Biomedical Research, Addison, Illinois, USA.'}, {'ForeName': 'Di', 'Initials': 'D', 'LastName': 'Xiao', 'Affiliation': 'Institute for Food Safety and Health, Illinois Institute of Technology, Chicago, Illinois, USA.'}, {'ForeName': 'Meredith L', 'Initials': 'ML', 'LastName': 'Wilcox', 'Affiliation': 'MB Clinical Research, Boca Raton, Florida, USA.'}, {'ForeName': 'Mary R', 'Initials': 'MR', 'LastName': 'Dicklin', 'Affiliation': 'Midwest Biomedical Research, Addison, Illinois, USA.'}, {'ForeName': 'Melvyn', 'Initials': 'M', 'LastName': 'Kramer', 'Affiliation': 'MB Clinical Research, Boca Raton, Florida, USA.'}, {'ForeName': 'Rupal', 'Initials': 'R', 'LastName': 'Trivedi', 'Affiliation': 'Great Lakes Clinical Trials, Chicago, Illinois, USA.'}, {'ForeName': 'Britt', 'Initials': 'B', 'LastName': 'Burton-Freeman', 'Affiliation': 'Institute for Food Safety and Health, Illinois Institute of Technology, Chicago, Illinois, USA.'}, {'ForeName': 'Indika', 'Initials': 'I', 'LastName': 'Edirisinghe', 'Affiliation': 'Institute for Food Safety and Health, Illinois Institute of Technology, Chicago, Illinois, USA.'}]",Journal of the American College of Nutrition,['10.1080/07315724.2019.1660929'] 1428,32424045,C-reactive protein-guided antibiotic prescribing for COPD exacerbations: a qualitative evaluation.,"BACKGROUND Antibiotics are prescribed to >70% of patients presenting in primary care with an acute exacerbation of chronic obstructive pulmonary disease (AECOPD). The PACE randomised controlled trial found that a C-reactive protein point-of-care test (CRP-POCT) management strategy for AECOPD in primary care resulted in a 20% reduction in patient-reported antibiotic consumption over 4 weeks. AIM To understand perceptions of the value of CRP-POCT for guiding antibiotic prescribing for AECOPD; explore possible mechanisms, mediators, and pathways to effects; and identify potential barriers and facilitators to implementation from the perspectives of patients and clinicians. DESIGN AND SETTING Qualitative process evaluation in UK general practices. METHOD Semi-structured telephone interviews with 20 patients presenting with an AECOPD and 20 primary care staff, purposively sampled from the PACE study. Interviews were audio-recorded, transcribed, and analysed using framework analysis. RESULTS Patients and clinicians felt that CRP-POCT was useful in guiding clinicians' antibiotic prescribing decisions for AECOPD, and were positive about introduction of the test in routine care. The CRP-POCT enhanced clinician confidence in antibiotic prescribing decisions, reduced decisional ambiguity, and facilitated communication with patients. Some clinicians thought the CRP-POCT should be routinely used in consultations for AECOPD; others favoured use only when there was decisional uncertainty. CRP-POCT cartridge preparation time and cost were potential barriers to implementation. CONCLUSION CRP-POCT-guided antibiotic prescribing for AECOPD had high acceptability, but commissioning arrangements and further simplification of the CRP-POCT need attention to facilitate implementation in routine practice.",2020,"The CRP-POCT enhanced clinician confidence in antibiotic prescribing decisions, reduced decisional ambiguity, and facilitated communication with patients.","['Qualitative process evaluation in UK general practices', 'COPD exacerbations', 'Semi-structured telephone interviews with 20 patients presenting with an AECOPD and 20 primary care staff, purposively sampled from the PACE study', 'patients presenting in primary care with an acute exacerbation of chronic obstructive pulmonary disease (AECOPD']","['C-reactive protein point-of-care test (CRP-POCT', 'C-reactive protein-guided antibiotic prescribing']",[],"[{'cui': 'C0205556', 'cui_str': 'Qualitative'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0015607', 'cui_str': 'Family practice'}, {'cui': 'C0740304', 'cui_str': 'COPD exacerbation'}, {'cui': 'C0021823', 'cui_str': 'Interviews, Telephone'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0340044', 'cui_str': 'Acute exacerbation of chronic obstructive airways disease'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0287990', 'cui_str': 'Furin'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C1319069', 'cui_str': 'Point of care testing'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}]",[],20.0,0.0494891,"The CRP-POCT enhanced clinician confidence in antibiotic prescribing decisions, reduced decisional ambiguity, and facilitated communication with patients.","[{'ForeName': 'Rhiannon', 'Initials': 'R', 'LastName': 'Phillips', 'Affiliation': 'Cardiff School of Sport and Health Sciences, Cardiff Metropolitan University, Cardiff, UK.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Stanton', 'Affiliation': 'Centre for Trials Research, School of Medicine, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Amina', 'Initials': 'A', 'LastName': 'Singh-Mehta', 'Affiliation': 'Research and Innovation Services, College of Biomedical and Life Sciences, Cardiff University, Cardiff, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Gillespie', 'Affiliation': 'Centre for Trials Research, School of Medicine, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Janine', 'Initials': 'J', 'LastName': 'Bates', 'Affiliation': 'Centre for Trials Research, School of Medicine, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Micaela', 'Initials': 'M', 'LastName': 'Gal', 'Affiliation': 'Research and Innovation Services, College of Biomedical and Life Sciences, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Thomas-Jones', 'Affiliation': 'Centre for Trials Research, School of Medicine, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Lowe', 'Affiliation': 'Centre for Trials Research, School of Medicine, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Kerenza', 'Initials': 'K', 'LastName': 'Hood', 'Affiliation': 'Centre for Trials Research, School of Medicine, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Carl', 'Initials': 'C', 'LastName': 'Llor', 'Affiliation': 'University Institute in Primary Care Research Jordi Gol, Via Roma Health Centre, Barcelona, Spain.'}, {'ForeName': 'Hasse', 'Initials': 'H', 'LastName': 'Melbye', 'Affiliation': 'General Practice Research Unit, Department of Community Medicine, UIT the Arctic University of Norway, Tromsø, Norway.'}, {'ForeName': 'Jochen', 'Initials': 'J', 'LastName': 'Cals', 'Affiliation': 'Department of Family Medicine, CAPHRI Care and Public Health Institute, Maastricht University, Maastricht, the Netherlands.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'White', 'Affiliation': ""Population Health and Environment Sciences, King's College London, London, UK.""}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Butler', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Francis', 'Affiliation': 'School of Primary Care, Population Sciences and Medical Education, University of Southampton, Southampton, UK.'}]",The British journal of general practice : the journal of the Royal College of General Practitioners,['10.3399/bjgp20X709865'] 1429,31538488,Effectiveness of a peer support intervention for antenatal depression: a feasibility study.,"OBJECTIVE A feasibility study for a randomised controlled trial to assess the acceptability, recruitment, feasibility and effectiveness of a peer support intervention for women with antenatal depression. The key premise of peer support is based upon the trust and empathetic understanding engendered by common experiences. METHOD Twenty pregnant women were recruited by their community midwife using the Whooley questionnaire at between 28-30 weeks' gestation to ascertain their level of mood and general mental health. Women identified as having potential antenatal depression were randomly assigned into a control group (routine care alone which includes contact with a midwife and in some case an obstetric Doctor with access to a GP if required) or intervention group (6-weekly visits from a peer support worker in addition to routine care). Participants from both the control and intervention group, and the Peer Support Workers (PSWs) were then interviewed at the end of the six-week period. All participants, and the PSW's, were also asked to keep log books during the trial to record their feelings and experiences. The results were then analysed using thematic analysis. RESULTS The analysis of qualitative data from the PSWs, and the participants in the intervention group, suggest the peer support intervention is acceptable, helpful and supportive to both pregnant women and, indeed, the PSWs. The women within the intervention group valued the peer support highly, reporting that being able to speak openly to a PSW meant that feelings of alienation, abnormality, isolation and stigma were replaced with social support, confidence, self-esteem and hope for recovery. The PSWs reported a positive impact upon their own wellbeing and a realisation that they had, indeed, moved forward with their lives. A proportion of the women randomised to the control group described feelings of disappointment and frustration with the lack of support currently available to them. CONCLUSION This feasibility study suggests a full randomised controlled trial (RCT) is warranted given the high recruitment, adherence, and acceptability of the intervention to participants.",2020,"A feasibility study for a randomised controlled trial to assess the acceptability, recruitment, feasibility and effectiveness of a peer support intervention for women with antenatal depression.","['women with antenatal depression', 'Women identified as having potential antenatal depression', ""Twenty pregnant women were recruited by their community midwife using the Whooley questionnaire at between 28-30\xa0weeks' gestation to ascertain their level of mood and general mental health"", 'antenatal depression']","['control group (routine care alone which includes contact with a midwife and in some case an obstetric Doctor with access to a GP if required) or intervention group (6-weekly visits from a peer support worker in addition to routine care', 'peer support intervention']","['acceptability, recruitment, feasibility and effectiveness']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C2828394', 'cui_str': 'Antenatal (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0401997', 'cui_str': 'Community midwife (occupation)'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0424113', 'cui_str': 'Level of mood (observable entity)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0332158', 'cui_str': 'Contact with (contextual qualifier) (qualifier value)'}, {'cui': 'C0026083', 'cui_str': 'Midwife'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}]",20.0,0.0979689,"A feasibility study for a randomised controlled trial to assess the acceptability, recruitment, feasibility and effectiveness of a peer support intervention for women with antenatal depression.","[{'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Carter', 'Affiliation': 'School of Health and Social Care, Staffordshire University , Stoke-on-Trent, United Kingdom of Great Britain and Northern Ireland.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Cust', 'Affiliation': 'School of Health and Social Care, Staffordshire University , Stoke-on-Trent, United Kingdom of Great Britain and Northern Ireland.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Boath', 'Affiliation': 'School of Health and Social Care, Staffordshire University , Stoke-on-Trent, United Kingdom of Great Britain and Northern Ireland.'}]",Journal of reproductive and infant psychology,['10.1080/02646838.2019.1668547'] 1430,31455824,"Morphine compared to placebo for procedural pain in preterm infants: safety, efficacy and equipoise.",,2019,,['preterm infants'],"['placebo', 'Morphine']",[],"[{'cui': 'C4048294', 'cui_str': 'Preterm Infant'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}]",[],,0.11121,,"[{'ForeName': 'Omri David', 'Initials': 'OD', 'LastName': 'Soffer', 'Affiliation': ""Division of Newborn Medicine, Boston Children's Hospital, Boston, MA, USA. Omri.soffer@childrens.harvard.edu.""}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Cornelissen', 'Affiliation': ""Division of Pain Medicine, Department of Anesthesiology, Critical Care and Pain Medicine, Boston Children's Hospital, Boston, MA, USA.""}, {'ForeName': 'Christy', 'Initials': 'C', 'LastName': 'Cummings', 'Affiliation': ""Division of Newborn Medicine, Boston Children's Hospital, Boston, MA, USA.""}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Berde', 'Affiliation': ""Division of Pain Medicine, Department of Anesthesiology, Critical Care and Pain Medicine, Boston Children's Hospital, Boston, MA, USA.""}]",Journal of perinatology : official journal of the California Perinatal Association,['10.1038/s41372-019-0476-9'] 1431,31272495,HIV-1 self-testing to improve the efficiency of pre-exposure prophylaxis delivery: a randomized trial in Kenya.,"BACKGROUND The introduction of pre-exposure prophylaxis (PrEP) for human immunodeficiency virus-1 (HIV-1) prevention in Africa presents new challenges for health systems that are already overburdened because PrEP delivery requires frequent clinic visits (generally every 3 months) for HIV-1 testing and PrEP refills. HIV-1 self-testing (HIVST) has the potential to improve the efficiency of PrEP delivery by decreasing the number of clinic visits. Here, we describe the rationale and design of a randomized, noninferiority trial designed to test the effectiveness and safety of using HIVST to support PrEP delivery in Kenya. METHODS The JiPime-JiPrEP (Kiswahili for 'Test Yourself, PrEP Yourself') study is a three-arm randomized trial taking place in Thika, Kenya. Participants (n = 495) are eligible for enrollment if they are at least 18 years old, HIV-1 seronegative, and have been taking PrEP for 1 month. Three distinct participant types will be enrolled: men (n = 165) and women (n = 165) who are in mutually disclosed HIV-1 serodiscordant relationships, and women (n = 165) who are at HIV-1 risk and not in a known serodiscordant relationship. Participants in each of these subpopulations will be 1:1:1 randomized to: 1) the standard of care, with quarterly clinic visits; 2) oral HIVST, with biannual clinic visits plus oral HIVSTs to use at the quarters between those visits; or 3) blood-based HIVST, with biannual clinic visits plus blood-based HIVSTs. All participants will complete quantitative surveys and provide blood samples for the objective measurement of PrEP adherence at baseline, 6 months, and 12 months. The primary outcomes are PrEP adherence, PrEP continuation, and HIV-1 testing, measured at 6 months and secondarily at 12 months. DISCUSSION The findings from this trial can help to understand how HIVST-a new HIV-1 testing technology-can support health systems in sub-Saharan Africa. Additionally, the findings can inform policy aimed at improving the efficiency of PrEP implementation and scale-up in Kenya. TRIAL REGISTRATION ClinicalTrials.gov, NCT03593629 . Retrospectively registered on 20 July 2018.",2019,self-testing (HIVST) has the potential to improve the efficiency of PrEP delivery by decreasing the number of clinic visits.,"['Three distinct participant types will be enrolled: men (n\xa0=\u2009165) and women (n\xa0=\u2009165) who are in mutually disclosed HIV-1 serodiscordant relationships, and women (n\xa0=\u2009165) who are\xa0at HIV-1 risk and not in a known serodiscordant relationship', 'Participants (n\xa0=\u2009495) are eligible for enrollment if they are at least 18\u2009years old, HIV-1 seronegative, and have been taking PrEP for 1 month', 'Kenya', 'human immunodeficiency virus-1 (HIV-1) prevention in Africa']","['pre-exposure prophylaxis (PrEP', 'HIVST, with biannual clinic visits plus oral HIVSTs to use at the quarters between those visits; or 3) blood-based HIVST, with biannual clinic visits plus blood-based HIVSTs', 'self-testing (HIVST', 'HIVST']","['HIV-1', 'PrEP adherence, PrEP continuation, and HIV-1 testing, measured at 6\u2009months and secondarily at 12\u2009months']","[{'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C4319555', 'cui_str': '165 (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0019704', 'cui_str': 'HIV-I'}, {'cui': 'C0439849', 'cui_str': 'Relationships (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0205309', 'cui_str': 'Known (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0521144', 'cui_str': 'Seronegative (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0022558', 'cui_str': 'Republic of Kenya'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0001737', 'cui_str': 'Africa'}]","[{'cui': 'C3850098', 'cui_str': 'Pre-Exposure Prophylaxis (PrEP)'}, {'cui': 'C0008952', 'cui_str': 'Clinic Visits'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0005768'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0036588', 'cui_str': 'Self'}]","[{'cui': 'C0019704', 'cui_str': 'HIV-I'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]",,0.078652,self-testing (HIVST) has the potential to improve the efficiency of PrEP delivery by decreasing the number of clinic visits.,"[{'ForeName': 'Katrina F', 'Initials': 'KF', 'LastName': 'Ortblad', 'Affiliation': 'Department of Global Health, University of Washington, 908 Jefferson St, Seattle, WA, 98104, USA. katort@uw.edu.'}, {'ForeName': 'John E', 'Initials': 'JE', 'LastName': 'Kearney', 'Affiliation': 'Department of Global Health, University of Washington, 908 Jefferson St, Seattle, WA, 98104, USA.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Mugwanya', 'Affiliation': 'Department of Global Health, University of Washington, 908 Jefferson St, Seattle, WA, 98104, USA.'}, {'ForeName': 'Elizabeth M', 'Initials': 'EM', 'LastName': 'Irungu', 'Affiliation': 'Department of Global Health, University of Washington, 908 Jefferson St, Seattle, WA, 98104, USA.'}, {'ForeName': 'Jessica E', 'Initials': 'JE', 'LastName': 'Haberer', 'Affiliation': 'Massachusetts General Hospital, Boston, USA.'}, {'ForeName': 'Ruanne V', 'Initials': 'RV', 'LastName': 'Barnabas', 'Affiliation': 'Department of Global Health, University of Washington, 908 Jefferson St, Seattle, WA, 98104, USA.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Donnell', 'Affiliation': 'Department of Global Health, University of Washington, 908 Jefferson St, Seattle, WA, 98104, USA.'}, {'ForeName': 'Nelly Rwamba', 'Initials': 'NR', 'LastName': 'Mugo', 'Affiliation': 'Department of Global Health, University of Washington, 908 Jefferson St, Seattle, WA, 98104, USA.'}, {'ForeName': 'Jared M', 'Initials': 'JM', 'LastName': 'Baeten', 'Affiliation': 'Department of Global Health, University of Washington, 908 Jefferson St, Seattle, WA, 98104, USA.'}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Ngure', 'Affiliation': 'Department of Community Health, Jomo Kenyatta University of Agriculture and Technology, Nairobi, Kenya.'}]",Trials,['10.1186/s13063-019-3521-2'] 1432,21087463,"Management of irritable bowel syndrome in primary care: feasibility randomised controlled trial of mebeverine, methylcellulose, placebo and a patient self-management cognitive behavioural therapy website. (MIBS trial).","BACKGROUND IBS affects 10-22% of the UK population. Abdominal pain, bloating and altered bowel habit affect quality of life, social functioning and time off work. Current GP treatment relies on a positive diagnosis, reassurance, lifestyle advice and drug therapies, but many suffer ongoing symptoms.A recent Cochrane review highlighted the lack of research evidence for IBS drugs. Neither GPs, nor patients have good evidence to inform prescribing decisions. However, IBS drugs are widely used: In 2005 the NHS costs were nearly £10 million for mebeverine and over £8 million for fibre-based bulking agents. CBT and self-management can be helpful, but poor availability in the NHS restricts their use. We have developed a web-based CBT self-management programme, Regul8, based on an existing evidence based self-management manual and in partnership with patients. This could increase access with minimal increased costs. METHODS/DESIGN The aim is to undertake a feasibility factorial RCT to assess the effectiveness of the commonly prescribed medications in UK general practice for IBS: mebeverine (anti-spasmodic) and methylcellulose (bulking-agent) and Regul8, the CBT based self-management website.135 patients aged 16 to 60 years with IBS symptoms fulfilling Rome III criteria, recruited via GP practices, will be randomised to 1 of 3 levels of the drug condition: mebeverine, methylcellulose or placebo for 6 weeks and to 1 of 3 levels of the website condition, Regul8 with a nurse telephone session and email support, Regul8 with minimal email support, or no website, thus creating 9 groups. OUTCOMES Irritable bowel symptom severity scale and IBS-QOL will be measured at baseline, 6 and 12 weeks as the primary outcomes. An intention to treat analysis will be undertaken by ANCOVA for a factorial trial. DISCUSSION This pilot will provide valuable information for a larger trial. Determining the effectiveness of commonly used drug treatments will help patients and doctors make informed treatment decisions regarding drug management of IBS symptoms, enabling better targeting of treatment. A web-based self-management CBT programme for IBS developed in partnership with patients has the potential to benefit large numbers of patients with low cost to the NHS. Assessment of the amount of email or therapist support required for the website will enable economic analysis to be undertaken.",2010,"Determining the effectiveness of commonly used drug treatments will help patients and doctors make informed treatment decisions regarding drug management of IBS symptoms, enabling better targeting of treatment.","['website.135 patients aged 16 to 60 years with IBS symptoms fulfilling Rome III criteria, recruited via GP practices', 'irritable bowel syndrome in primary care']","['mebeverine, methylcellulose, placebo', 'mebeverine, methylcellulose or placebo', 'website condition, Regul8 with a nurse telephone session and email support, Regul8 with minimal email support, or no website, thus creating 9 groups']","['Abdominal pain, bloating and altered bowel habit affect quality of life, social functioning and time off work', 'Irritable bowel symptom severity scale and IBS-QOL']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0035831', 'cui_str': 'Rome'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0022104', 'cui_str': 'Irritable Bowel Syndrome'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}]","[{'cui': 'C0065832', 'cui_str': 'mebeverine'}, {'cui': 'C0025729', 'cui_str': 'Methylcellulose'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0013849', 'cui_str': 'Email'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0547040', 'cui_str': 'Minimal (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0000737', 'cui_str': 'Abdominal Pain'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0585074', 'cui_str': 'Amount of time off work'}, {'cui': 'C0022104', 'cui_str': 'Irritable Bowel Syndrome'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity (finding)'}, {'cui': 'C0222045'}]",,0.123461,"Determining the effectiveness of commonly used drug treatments will help patients and doctors make informed treatment decisions regarding drug management of IBS symptoms, enabling better targeting of treatment.","[{'ForeName': 'Hazel A', 'Initials': 'HA', 'LastName': 'Everitt', 'Affiliation': 'Primary Medical Care, School of Medicine, University of Southampton, Southampton SO17 1BJ, UK. H.A.Everitt@soton.ac.uk'}, {'ForeName': 'Rona E', 'Initials': 'RE', 'LastName': 'Moss-Morris', 'Affiliation': ''}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Sibelli', 'Affiliation': ''}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Tapp', 'Affiliation': ''}, {'ForeName': 'Nicholas S', 'Initials': 'NS', 'LastName': 'Coleman', 'Affiliation': ''}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Yardley', 'Affiliation': ''}, {'ForeName': 'Peter W', 'Initials': 'PW', 'LastName': 'Smith', 'Affiliation': ''}, {'ForeName': 'Paul S', 'Initials': 'PS', 'LastName': 'Little', 'Affiliation': ''}]",BMC gastroenterology,['10.1186/1471-230X-10-136'] 1433,30654713,The Effect of an HIV Self-Management Intervention on Neurocognitive Behavioral Processing.,"People living with HIV (PLHIV) are increasingly diagnosed with comorbidities which require increasing self-management. We examined the effect of a self-management intervention on neurocognitive behavioral processing. Twenty-nine PLHIV completed a two-group, 3-month randomized clinical trial testing a self-management intervention to improve physical activity and dietary intake. At baseline and 3 months later, everyone completed validated assessments of physical, diet, and neurocognitive processing (functional magnetic resonance imaging [fMRI]-derived network analyses). We used linear mixed effects modeling with a random intercept to examine the effect of the intervention. The intervention improved healthy eating ( p = .08) but did not improve other self-management behaviors. There was a significant effect of the intervention on several aspects of neurocognitive processing including in the task positive network (TPN) differentiation ( p = .047) and an increase in the default mode network (DMN) differentiation ( p = .10). Self-management interventions may influence neurocognitive processing in PLHIV, but those changes were not associated with positive changes in self-management behavior.",2019,There was a significant effect of the intervention on several aspects of neurocognitive processing including in the task positive network (TPN) differentiation ( p = .047) and an increase in the default mode network (DMN) differentiation ( p = .10).,"['People living with HIV (PLHIV', 'Twenty-nine PLHIV']","['HIV Self-Management Intervention', 'self-management intervention', 'self-management intervention to improve physical activity and dietary intake']","['Neurocognitive Behavioral Processing', 'physical, diet, and neurocognitive processing (functional magnetic resonance imaging [fMRI]-derived network analyses', 'self-management behaviors', 'neurocognitive behavioral processing', 'default mode network (DMN) differentiation', 'healthy eating', 'task positive network (TPN) differentiation']","[{'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0450351', 'cui_str': '29 (qualifier value)'}]","[{'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0086969', 'cui_str': 'Self-Management'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}]","[{'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0376335', 'cui_str': 'fMRI'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0086969', 'cui_str': 'Self-Management'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0452415', 'cui_str': 'Healthy Diet'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}]",29.0,0.0334739,There was a significant effect of the intervention on several aspects of neurocognitive processing including in the task positive network (TPN) differentiation ( p = .047) and an increase in the default mode network (DMN) differentiation ( p = .10).,"[{'ForeName': 'Allison R', 'Initials': 'AR', 'LastName': 'Webel', 'Affiliation': '1 Frances Payne Bolton School of Nursing, Case Western Reserve University, Cleveland, OH, USA.'}, {'ForeName': 'Nathaniel', 'Initials': 'N', 'LastName': 'Schreiner', 'Affiliation': '1 Frances Payne Bolton School of Nursing, Case Western Reserve University, Cleveland, OH, USA.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Salata', 'Affiliation': '1 Frances Payne Bolton School of Nursing, Case Western Reserve University, Cleveland, OH, USA.'}, {'ForeName': 'Jared', 'Initials': 'J', 'LastName': 'Friedman', 'Affiliation': '1 Frances Payne Bolton School of Nursing, Case Western Reserve University, Cleveland, OH, USA.'}, {'ForeName': 'Anthony I', 'Initials': 'AI', 'LastName': 'Jack', 'Affiliation': '1 Frances Payne Bolton School of Nursing, Case Western Reserve University, Cleveland, OH, USA.'}, {'ForeName': 'Abdus', 'Initials': 'A', 'LastName': 'Sattar', 'Affiliation': '1 Frances Payne Bolton School of Nursing, Case Western Reserve University, Cleveland, OH, USA.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Fresco', 'Affiliation': '3 Kent State University, OH, USA.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Rodriguez', 'Affiliation': '1 Frances Payne Bolton School of Nursing, Case Western Reserve University, Cleveland, OH, USA.'}, {'ForeName': 'Shirley', 'Initials': 'S', 'LastName': 'Moore', 'Affiliation': '1 Frances Payne Bolton School of Nursing, Case Western Reserve University, Cleveland, OH, USA.'}]",Western journal of nursing research,['10.1177/0193945918823347'] 1434,31535360,An Overnight Stay Versus three Days Admission after Uncomplicated Percutaneous Nephrolithotomy: A Randomized Clinical Trial.,"PURPOSE To evaluate the safety and efficacy of discharging patients on the first postoperative day after an uncomplicated percutaneous nephrolithotomy (PCNL). MATERIALS AND METHODS after an uncomplicated successful PCNL without significant residual stone (>5mm) or any complication up to the first postoperative day, we randomly assigned patients into two groups-Group 1: overnight surgery, and Group 2: routine discharge after three days. Patients with significant residual stone on control fluoroscopy were excluded. Ninety eight and 102 patients were assigned to groups 1 and 2, respectively. Serum Hemoglobin and Cr were evaluated before the operation as well as the first postoperative day. Stone free status was evaluated using ultrasound and KUB radiography at the first postoperative day. RESULTS The stone and patient characteristics were not different in two groups. The preoperative and change in the hemoglobin and creatinine levels were not significantly different between the two groups. Nine patients (9.2%) in Group 1 and five (4.9%) in Group 2 were readmitted because of complications (mainly hematuria) (p=.23). Of the readmitted patients, five in Group 1 (55%), and three in Group 2 (60%) received blood transfusion (p=.87). in these patients, group 1 received 1.6±0.51 units of blood compared with 1.93±0.25 in group 2 (p=.07). All the readmitted patients did well with conservative therapy with no need for angioembolization. CONCLUSION In uncomplicated PCNL with no significant residual stone, discharging the patient on the first postoperative day is safe. The outcome is comparable to a routine three-day hospital stay.",2020,The preoperative and change in the hemoglobin and creatinine levels were not significantly different between the two groups.,"['after an uncomplicated successful PCNL without significant residual stone (>5mm) or any complication up to the first postoperative day', 'Patients with significant residual stone on control fluoroscopy were excluded', 'Ninety eight and 102 patients']","['overnight surgery, and Group 2: routine discharge', 'Overnight Stay Versus three Days Admission after uncomplicated Percutaneous Nephrolithotomy', 'uncomplicated percutaneous nephrolithotomy (PCNL']","['Serum Hemoglobin and Cr', 'blood transfusion', 'hemoglobin and creatinine levels', 'safety and efficacy']","[{'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C1609982', 'cui_str': 'Residual (qualifier value)'}, {'cui': 'C0006736', 'cui_str': 'Biliary or Urinary Stones'}, {'cui': 'C0439084', 'cui_str': '>5 (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0016356', 'cui_str': 'Fluoroscopy'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C4319627', 'cui_str': 'Ninety-eight'}]","[{'cui': 'C0439583', 'cui_str': 'Overnight (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0441865', 'cui_str': 'Group 2 (qualifier value)'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0162428', 'cui_str': 'Nephrolithotomy, Percutaneous'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C1273858', 'cui_str': 'Transfusion Medicine'}, {'cui': 'C0428279', 'cui_str': 'Finding of creatinine level (finding)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.0356594,The preoperative and change in the hemoglobin and creatinine levels were not significantly different between the two groups.,"[{'ForeName': 'Abbas', 'Initials': 'A', 'LastName': 'Basiri', 'Affiliation': 'Urology and Nephrology Research Center, Shahid Labbafinejad Medical Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran. Basiri@unrc.ir.'}, {'ForeName': 'Davood', 'Initials': 'D', 'LastName': 'Arab', 'Affiliation': 'Department of Surgery, Kowsar Hospital, Semnan University of Medical Sciences, Semnan, Iran. drdavoodarab@yahoo.com.'}, {'ForeName': 'Hamid', 'Initials': 'H', 'LastName': 'Pakmanesh', 'Affiliation': 'Department of urology, Faculty of Medicine, Kerman University of Medical Sciences, Kerman, Iran. h_pakmanesh@yahoo.com.'}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Abedinzadeh', 'Affiliation': 'Department of urology, Shahid Rahnemoon Hospital, Sahid Sadooghi University of Medical Sciences, Yazd, Iran. abedinoro@yahoo.com.'}, {'ForeName': 'Hormoz', 'Initials': 'H', 'LastName': 'Karami', 'Affiliation': 'Department of urology, Shahid Rahnemoon Hospital, Sahid Sadooghi University of Medical Sciences, Yazd, Iran. hormozkarami@yahoo.com.'}]",Urology journal,['10.22037/uj.v0i0.5314'] 1435,31580144,Cluster randomised trials with different numbers of measurements at baseline and endline: Sample size and optimal allocation.,"BACKGROUND/AIMS Published methods for sample size calculation for cluster randomised trials with baseline data are inflexible and primarily assume an equal amount of data collected at baseline and endline, that is, before and after the intervention has been implemented in some clusters. We extend these methods to any amount of baseline and endline data. We explain how to explore sample size for a trial if some baseline data from the trial clusters have already been collected as part of a separate study. Where such data aren't available, we show how to choose the proportion of data collection devoted to the baseline within the trial, when a particular cluster size or range of cluster sizes is proposed. METHODS We provide a design effect given the cluster size and correlation parameters, assuming different participants are assessed at baseline and endline in the same clusters. We show how to produce plots to identify the impact of varying the amount of baseline data accounting for the inevitable uncertainty in the cluster autocorrelation. We illustrate the methodology using an example trial. RESULTS Baseline data provide more power, or allow a greater reduction in trial size, with greater values of the cluster size, intracluster correlation and cluster autocorrelation. CONCLUSION Investigators should think carefully before collecting baseline data in a cluster randomised trial if this is at the expense of endline data. In some scenarios, this will increase the sample size required to achieve given power and precision.",2020,"RESULTS Baseline data provide more power, or allow a greater reduction in trial size, with greater values of the cluster size, intracluster correlation and cluster autocorrelation. ",[],[],[],[],[],[],,0.33338,"RESULTS Baseline data provide more power, or allow a greater reduction in trial size, with greater values of the cluster size, intracluster correlation and cluster autocorrelation. ","[{'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Copas', 'Affiliation': 'Institute for Clinical Trials Methodology, MRC Clinical Trials Unit at University College London, London, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Hooper', 'Affiliation': 'Centre for Primary Care and Public Health, Queen Mary University of London, London, UK.'}]","Clinical trials (London, England)",['10.1177/1740774519873888'] 1436,31586194,Developing a Psychological-Behavioral Intervention in Cardiac Patients Using the Multiphase Optimization Strategy: Lessons Learned From the Field.,"BACKGROUND The Multiphase Optimization Strategy (MOST) is an approach to systematically and efficiently developing a behavioral intervention using a sequence of experiments to prepare and optimize the intervention. PURPOSE Using a 6 year MOST-based behavioral intervention development project as an example, we outline the results-and resulting decision-making process-related to experiments at each step to display the practical challenges present at each stage. METHODS To develop a positive psychology (PP) based intervention to promote physical activity after an acute coronary syndrome (N = 255 across four phases), we utilized qualitative, proof-of-concept, factorial design, and randomized pilot experiments, with iterative modification of intervention content and delivery. RESULTS Through this multiphase approach, we ultimately developed a 12 week, phone-delivered, combined PP-motivational interviewing intervention to promote physical activity. Across stages, we learned several important lessons: (a) participant and interventionist feedback is important, even in later optimization stages; (b) a thoughtful and systematic approach using all information sources is required when conflicting results in experiments make next steps unclear; and (3) new approaches in the field over a multiyear project should be integrated into the development process. CONCLUSIONS A MOST-based behavioral intervention development program can be efficient and effective in developing optimized new interventions, and it may require complex and nuanced decision-making at each phase.",2020,"BACKGROUND The Multiphase Optimization Strategy (MOST) is an approach to systematically and efficiently developing a behavioral intervention using a sequence of experiments to prepare and optimize the intervention. ",[],"['positive psychology (PP) based intervention', 'combined PP-motivational interviewing intervention', 'Multiphase Optimization Strategy']",[],[],"[{'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0033909', 'cui_str': 'Psychology'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0935630', 'cui_str': 'Interview'}]",[],255.0,0.0166421,"BACKGROUND The Multiphase Optimization Strategy (MOST) is an approach to systematically and efficiently developing a behavioral intervention using a sequence of experiments to prepare and optimize the intervention. ","[{'ForeName': 'Jeff C', 'Initials': 'JC', 'LastName': 'Huffman', 'Affiliation': 'Department of Psychiatry, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Rachel A', 'Initials': 'RA', 'LastName': 'Millstein', 'Affiliation': 'Department of Psychiatry, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': 'Celano', 'Affiliation': 'Department of Psychiatry, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Brian C', 'Initials': 'BC', 'LastName': 'Healy', 'Affiliation': 'Department of Psychiatry, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Elyse R', 'Initials': 'ER', 'LastName': 'Park', 'Affiliation': 'Department of Psychiatry, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Linda M', 'Initials': 'LM', 'LastName': 'Collins', 'Affiliation': 'The Methodology Center and Department of Human Development and Family Studies, Pennsylvania State University, University Park, PA, USA.'}]",Annals of behavioral medicine : a publication of the Society of Behavioral Medicine,['10.1093/abm/kaz035'] 1437,32037653,"Cardiovascular and kidney outcomes of linagliptin treatment in older people with type 2 diabetes and established cardiovascular disease and/or kidney disease: A prespecified subgroup analysis of the randomized, placebo-controlled CARMELINA® trial.","AIMS In CARMELINA®, linagliptin demonstrated cardiovascular and renal safety in patients with type 2 diabetes (T2D) with high renal and cardiovascular disease (CVD) risk. We investigated safety and efficacy of this dipeptidyl peptidase-4 inhibitor in older participants. MATERIALS AND METHODS Subjects aged ≥18 years with T2D and established CVD with urinary albumin-to-creatinine ratio (UACR) >30 mg/g, and/or prevalent kidney disease, were randomized to linagliptin or placebo added to usual care. The primary endpoint (time to first occurrence of 3P-MACE: cardiovascular death, non-fatal myocardial infarction or non-fatal stroke) and other outcomes were evaluated across age groups <65 (n = 2968), 65 to <75 (n = 2800) and ≥75 years (n = 1211). RESULTS Mean age was 65.9 years (17.4% and 5.9% aged ≥75 and 80, respectively) and median follow-up was 2.2 years. The hazard ratio (HR) for 3P-MACE with linagliptin versus placebo was 1.02 [95% confidence interval (CI) 0.89, 1.17] with no significant interaction between age and treatment effect (P = 0.0937). HRs for participants aged <65, 65 to <75 and ≥75 years were 1.11 (95% CI 0.89, 1.40), 1.09 (0.89, 1.33) and 0.76 (0.57, 1.02), respectively. Linagliptin did not increase the risk of adverse kidney outcomes or hospitalization for heart failure across age groups. The incidence of adverse events, including hypoglycaemia, increased with age but was similar with linagliptin and placebo despite glycated haemoglobin A1c reduction with linagliptin. CONCLUSIONS Linagliptin did not increase risk for cardiovascular events or hypoglycaemia and kidney function remained stable in older people with T2D and established CVD with albuminuria and/or kidney disease.",2020,"CONCLUSIONS Linagliptin did not increase risk for cardiovascular events or hypoglycaemia and kidney function remained stable in older people with T2D and established CVD with albuminuria, and/or kidney disease.","['older people with T2D and established CVD with albuminuria, and/or kidney disease', 'type 2 diabetic (T2D) patients with high renal and cardiovascular disease (CVD) risk', 'and/or prevalent kidney disease', 'Subjects aged ≥18\u2009years with T2D and established CVD with urinary albumin-to-creatinine ratio (UACR) ', 'older participants', 'older people with type 2 diabetes and established cardiovascular disease and/or kidney disease', 'Mean age was 65.9\u2009years (17.4% and 5.9% aged ≥75 and 80, respectively) and median follow-up 2.2\u2009years']","['®, linagliptin', 'linagliptin', 'placebo', 'linagliptin or placebo', 'Linagliptin', 'dipeptidyl peptidase-4 inhibitor']","['hazard ratio (HR', 'incidence of adverse events including hypoglycaemia', 'primary endpoint (time to first occurrence of 3P-MACE: cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke', 'risk of adverse kidney outcomes or hospitalization for heart failure', 'Cardiovascular and kidney outcomes', 'safety and efficacy', 'cardiovascular events or hypoglycaemia and kidney function', 'cardiovascular and renal safety']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0443211', 'cui_str': 'Established (qualifier value)'}, {'cui': 'C0001925', 'cui_str': 'Albuminuria'}, {'cui': 'C0022658', 'cui_str': 'Kidney Diseases'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3711292', 'cui_str': '68Ga-albumin'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C4517629', 'cui_str': '2.2'}]","[{'cui': 'C2746078', 'cui_str': 'Linagliptin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1827106', 'cui_str': 'Dipeptidyl-Peptidase 4 Inhibitors'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0349381', 'cui_str': 'Mace (substance)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0022646', 'cui_str': 'Kidney'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0031843', 'cui_str': 'function'}]",,0.350486,"CONCLUSIONS Linagliptin did not increase risk for cardiovascular events or hypoglycaemia and kidney function remained stable in older people with T2D and established CVD with albuminuria, and/or kidney disease.","[{'ForeName': 'Mark E', 'Initials': 'ME', 'LastName': 'Cooper', 'Affiliation': 'Department of Diabetes, Central Clinical School, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Julio', 'Initials': 'J', 'LastName': 'Rosenstock', 'Affiliation': 'Dallas Diabetes Research Center at Medical City, Dallas, Texas.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Kadowaki', 'Affiliation': 'Department of Prevention of Diabetes and Lifestyle-related Diseases, Graduate School of Medicine, University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Yutaka', 'Initials': 'Y', 'LastName': 'Seino', 'Affiliation': 'Kansai Electric Power Medical Research Institute, Osaka, Japan.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Wanner', 'Affiliation': 'Division of Nephrology, Department of Medicine, Würzburg University Clinic, Würzburg, Germany.'}, {'ForeName': 'Sven', 'Initials': 'S', 'LastName': 'Schnaidt', 'Affiliation': 'Boehringer Ingelheim Pharma GmbH & Co KG, Biberach, Germany.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Clark', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim, Germany.'}, {'ForeName': 'Odd Erik', 'Initials': 'OE', 'LastName': 'Johansen', 'Affiliation': 'Boehringer Ingelheim Norway KS, Asker, Norway.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Diabetes, obesity & metabolism",['10.1111/dom.13995'] 1438,32424169,Aerobic exercise impacts the anterior cingulate cortex in adolescents with subthreshold mood syndromes: a randomized controlled trial study.,"Aerobic exercise is effective in alleviating mood symptoms while the mechanism is poorly understood. There are limited clinical trials that investigated the effect of exercise on the anterior cingulate cortex (ACC), a key brain region involved in mood regulations, in adolescents with subthreshold mood syndromes. This randomized controlled trial (RCT) of aerobic exercise was undertaken in a middle school in Guangzhou, China. Participants were adolescents aged 12-14 with subthreshold mood syndromes including depressive and manic symptoms and were randomly assigned to an aerobic exercise intervention or a psychoeducation control group. Participants in the exercise group received moderate-intensity exercise intervention, consisting of 30 mins running, 4 days per week for 3 months. The primary outcome in this study was structural changes in the ACC from baseline to post intervention. The trial was registered with ClinicalTrial.gov (NCT03300778). Of 56 participants who met the criteria for subthreshold mood syndromes, 39 (41.03% males) had complete MRI data, with 20 and 19 subjects in the exercise and control group, respectively. At baseline, demographic information (e.g., age and sex), clinical symptoms, and the gray matter volume and cortical thickness of ACC were matched between the two groups. After 12 weeks of treatment, participants in the exercise group displayed increased gray matter volume of the left rostral ACC (F 1,30  = 5.73, p = 0.02) and increased cortical thickness of the right rostral ACC (F 1,30  = 7.83, p = 0.01) when compared with the control group. No significant differences were found for caudal ACC cortical thickness and gray matter volume. Our data demonstrate that 12-week, moderate-intensity aerobic exercise can induce structural changes in the rostral ACC in adolescents with subthreshold mood syndromes.",2020,No significant differences were found for caudal ACC cortical thickness and gray matter volume.,"['adolescents with subthreshold mood syndromes', '56 participants who met the criteria for subthreshold mood syndromes, 39 (41.03% males) had complete MRI data, with 20 and 19 subjects in the exercise and control group, respectively', 'Participants were adolescents aged 12-14 with subthreshold mood syndromes including depressive and manic symptoms', 'middle school in Guangzhou, China']","['Aerobic exercise', 'moderate-intensity exercise intervention', 'aerobic exercise intervention or a psychoeducation control group', 'aerobic exercise']","['gray matter volume and cortical thickness of ACC', 'caudal ACC cortical thickness and gray matter volume', 'gray matter volume of the left rostral ACC', 'cortical thickness of the right rostral ACC']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0338831', 'cui_str': 'Mania'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0557797', 'cui_str': 'Middle school'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0871175', 'cui_str': 'Psychoeducation'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0018220', 'cui_str': 'Grey Matter'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0175190', 'cui_str': 'Anterior Cingulate Gyrus'}, {'cui': 'C0205097', 'cui_str': 'Caudal'}, {'cui': 'C3163631', 'cui_str': 'Rostral'}, {'cui': 'C0205090', 'cui_str': 'Right'}]",56.0,0.118219,No significant differences were found for caudal ACC cortical thickness and gray matter volume.,"[{'ForeName': 'Kangguang', 'Initials': 'K', 'LastName': 'Lin', 'Affiliation': 'Department of Affective Disorders, The Affiliated Brain Hospital of Guangzhou Medical University (Guangzhou Huiai Hospital),Guangzhou Medical University, Guangzhou, China. linkangguang@163.com.'}, {'ForeName': 'Brendon', 'Initials': 'B', 'LastName': 'Stubbs', 'Affiliation': ""Department of Psychological Medicine, Institute of Psychiatry, Psychology, and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Wenjin', 'Initials': 'W', 'LastName': 'Zou', 'Affiliation': 'Department of Radiology, The Affiliated Hospital of Guangzhou Medical University (GuangzhouHuiai Hospital), Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Wenjing', 'Initials': 'W', 'LastName': 'Zheng', 'Affiliation': 'Department of Affective Disorders, The Affiliated Brain Hospital of Guangzhou Medical University (Guangzhou Huiai Hospital),Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Weicong', 'Initials': 'W', 'LastName': 'Lu', 'Affiliation': 'Department of Affective Disorders, The Affiliated Brain Hospital of Guangzhou Medical University (Guangzhou Huiai Hospital),Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Yanling', 'Initials': 'Y', 'LastName': 'Gao', 'Affiliation': 'Academician workstation of Mood and Brain Sciences, Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Kun', 'Initials': 'K', 'LastName': 'Chen', 'Affiliation': 'Academician workstation of Mood and Brain Sciences, Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Shengli', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'Department of Radiology, The Affiliated Hospital of Guangzhou Medical University (GuangzhouHuiai Hospital), Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Yuanxuan Middle School, Huadu district, Guangzhou, China.'}, {'ForeName': 'Yanxiong', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': 'Department of Affective Disorders, The Affiliated Brain Hospital of Guangzhou Medical University (Guangzhou Huiai Hospital),Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Lijie', 'Initials': 'L', 'LastName': 'Guan', 'Affiliation': 'Department of Affective Disorders, The Affiliated Brain Hospital of Guangzhou Medical University (Guangzhou Huiai Hospital),Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Mabel Ngai Kiu', 'Initials': 'MNK', 'LastName': 'Wong', 'Affiliation': 'Department of Rehabilitation Sciences, The Hong Kong Polytechnic University, Hung Hom, Hong Kong.'}, {'ForeName': 'Runhua', 'Initials': 'R', 'LastName': 'Wang', 'Affiliation': 'Department of Affective Disorders, The Affiliated Brain Hospital of Guangzhou Medical University (Guangzhou Huiai Hospital),Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Bess Yin-Hung', 'Initials': 'BY', 'LastName': 'Lam', 'Affiliation': 'Department of Rehabilitation Sciences, The Hong Kong Polytechnic University, Hung Hom, Hong Kong. bess.lam@polyu.edu.hk.'}, {'ForeName': 'Guiyun', 'Initials': 'G', 'LastName': 'Xu', 'Affiliation': 'Department of Affective Disorders, The Affiliated Brain Hospital of Guangzhou Medical University (Guangzhou Huiai Hospital),Guangzhou Medical University, Guangzhou, China.'}]",Translational psychiatry,['10.1038/s41398-020-0840-8'] 1439,31856838,"Effects of the Toll-like receptor 7 (TLR7) agonist, AZD8848, on allergen-induced responses in patients with mild asthma: a double-blind, randomised, parallel-group study.","BACKGROUND Although allergic asthma is a complex area with many interacting factors involved, the 'hygiene hypothesis' proposes that a lack of exposure to infection during childhood may polarise the immune system towards allergen-reactive Th2-type responses in genetically susceptible individuals. Toll-like receptors (TLRs) play a key role within the innate immune system and TLR7 agonists have previously been shown to up-regulate Th1 responses and down-regulate Th2 responses to allergens in murine models of allergic or chronic asthma. This study aimed to examine the efficacy and safety of the novel TRL7 agonist AZD8848, which has been developed as an antedrug. METHODS In this double-blind, randomised, parallel-group study, AZD8848 60 μg or placebo was administered intranasally once-weekly for 8 weeks in patients with mild-to-moderate allergic asthma (NCT00999466). Efficacy assessments were performed at 1 and 4 weeks after the last dose. The primary outcome was the late asthmatic response (LAR) fall in forced expiratory volume in 1 s (FEV 1 ) after allergen challenge at 1-week post-treatment. RESULTS AZD8848 significantly reduced average LAR fall in FEV 1 by 27% vs. placebo at 1 week after treatment (p = 0.035). This effect was sustained at 4 weeks post-treatment; however, it did not reach clinical significance. AZD8848 reduced post-allergen challenge methacholine-induced airway hyper-responsiveness (AHR) vs. placebo at 1 week post-dosing (treatment ratio: 2.20, p = 0.024), with no effect at 4 weeks. There was no significant difference between the two groups in plasma cytokine, sputum Th2 cytokine or eosinophil responses post-allergen challenge at 1 week after treatment. The incidence of adverse events was similar in the two groups. AZD8848 was generally well tolerated. CONCLUSIONS AND CLINICAL RELEVANCE In patients with allergic asthma, TLR7 agonists could potentially reduce allergen responsiveness by stimulating Type 1 interferon responses to down-regulate the dominant Th2 responses. TRIAL REGISTRATION clinicaltrials.gov identifier NCT00999466.",2019,"There was no significant difference between the two groups in plasma cytokine, sputum Th2 cytokine or eosinophil responses post-allergen challenge at 1 week after treatment.","['patients with allergic asthma', 'patients with mild asthma']","['Toll-like receptor 7 (TLR7) agonist, AZD8848', 'AZD8848 60\u2009μg or placebo', 'placebo']","['plasma cytokine, sputum Th2 cytokine or eosinophil responses post-allergen challenge', 'efficacy and safety', 'average LAR fall in FEV', 'airway hyper-responsiveness (AHR', 'adverse events', 'late asthmatic response (LAR) fall in forced expiratory volume in 1\u2009s (FEV 1 ', 'tolerated']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0155877', 'cui_str': 'Allergic asthma (disorder)'}, {'cui': 'C0581124', 'cui_str': 'Mild asthma'}]","[{'cui': 'C1579758', 'cui_str': 'Toll-Like Receptor 7'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C4277852', 'cui_str': 'AZD8848'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}, {'cui': 'C0038056', 'cui_str': 'Sputum'}, {'cui': 'C0014467', 'cui_str': 'Eosinophil, segmented (cell)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0002092', 'cui_str': 'Allergens'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0000921', 'cui_str': 'Falls'}, {'cui': 'C1306036', 'cui_str': 'Forced expiratory volume'}, {'cui': 'C0035228', 'cui_str': 'Airway Hyper-Responsiveness'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}]",,0.554305,"There was no significant difference between the two groups in plasma cytokine, sputum Th2 cytokine or eosinophil responses post-allergen challenge at 1 week after treatment.","[{'ForeName': 'Brian R', 'Initials': 'BR', 'LastName': 'Leaker', 'Affiliation': 'Respiratory Clinical Trials Ltd, Queen Anne Street Medical Centre, 18-22 Queen Anne Street, London, W1G 8HU, UK. brian.leaker@qasmc.com.'}, {'ForeName': 'Dave', 'Initials': 'D', 'LastName': 'Singh', 'Affiliation': 'Medicines Evaluation Unit, University of Manchester, University Hospital of South Manchester, Manchester, UK.'}, {'ForeName': 'Sam', 'Initials': 'S', 'LastName': 'Lindgren', 'Affiliation': 'Biopharmaceuticals R&D, Late-stage Development RIA, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Gun', 'Initials': 'G', 'LastName': 'Almqvist', 'Affiliation': 'Biopharmaceuticals R&D, Late-stage Development RIA, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Leif', 'Initials': 'L', 'LastName': 'Eriksson', 'Affiliation': 'Early Clinical Development, AstraZeneca R&D, Mölndal, Sweden.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Young', 'Affiliation': 'Discovery Bioscience, AstraZeneca R&D, Loughborough, UK.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': ""O'Connor"", 'Affiliation': 'Respiratory Clinical Trials Ltd, Queen Anne Street Medical Centre, 18-22 Queen Anne Street, London, W1G 8HU, UK.'}]",Respiratory research,['10.1186/s12931-019-1252-2'] 1440,31814292,Combined CO 2 laser and photodynamic therapy enhances the efficacy of treatment of basal cell carcinomas.,"BACKGROUND AND OBJECTIVES In selected cases, conventional photodynamic therapy (C-PDT) is a valid alternative to surgery for the treatment of basal cell carcinoma (BCC). However, it is limited to superficial BCCs. Pretreatment of BCCs with ablative lasers may enhance its efficacy. We evaluated the C-PDT and CO 2 laser combination therapy for the treatment of superficial and nodular BCCs. PATIENTS AND METHODS In this prospective, interventional, monocentric study, patients affected by BCC were treated with CO 2 laser therapy, using a continuous superpulsed CO 2 laser for nodular BCCs and a fractional CO 2 laser for superficial BCCs. All patients were subsequently treated with photodynamic therapy using methyl aminolevulinate cream and an Aktilite CL128® (Galderma) lamp. RESULTS 32 patients (20 males, 12 females) aged from 45 to 96 years (with a total of 181 BCCs) were treated using a CO 2 laser combined with C-PDT. A 100 % cure rate was achieved at three months, with no signs of relapse in 97.2 % of the cases during the mean follow-up period (10.7 months, range 4 to 18 months). We observed mild adverse reactions and good aesthetic results. CONCLUSIONS We recommend this combination therapy in selected cases, based on its high efficacy, good aesthetic results and few side effects.",2019,"A 100 % cure rate was achieved at three months, with no signs of relapse in 97.2 % of the cases during the mean follow-up period (10.7 months, range 4 to 18 months).","['32 patients (20 males, 12 females) aged from 45 to 96 years (with a total of 181 BCCs', 'basal cell carcinomas']","['photodynamic therapy using methyl aminolevulinate cream and an Aktilite CL128® (Galderma) lamp', 'conventional photodynamic therapy (C-PDT', 'BCCs with ablative lasers', 'CO 2 laser combined with C-PDT', 'Combined CO 2 laser and photodynamic therapy', 'CO 2 laser therapy']","['mild adverse reactions and good aesthetic results', 'cure rate', 'signs of relapse']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0205112', 'cui_str': 'Basal (qualifier value)'}, {'cui': 'C0007634', 'cui_str': 'Cells'}]","[{'cui': 'C0031740', 'cui_str': 'Photodynamic Therapy'}, {'cui': 'C1134467', 'cui_str': 'methyl aminolevulinate'}, {'cui': 'C1378128', 'cui_str': 'Cream'}, {'cui': 'C0392223', 'cui_str': 'Lamp'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0044588', 'cui_str': 'PDT'}, {'cui': 'C0023089', 'cui_str': 'Lasers'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C1955835', 'cui_str': 'Laser Therapy'}]","[{'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction (disorder)'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0014901', 'cui_str': 'Esthetics'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0311392', 'cui_str': 'Sign'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}]",32.0,0.0176694,"A 100 % cure rate was achieved at three months, with no signs of relapse in 97.2 % of the cases during the mean follow-up period (10.7 months, range 4 to 18 months).","[{'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Ferrara', 'Affiliation': 'Dermatology, Department of Experimental, Diagnostic and Specialty Medicine, University of Bologna, Bologna, Italy.'}, {'ForeName': 'Rossella', 'Initials': 'R', 'LastName': 'Lacava', 'Affiliation': 'Dermatology, Department of Experimental, Diagnostic and Specialty Medicine, University of Bologna, Bologna, Italy.'}, {'ForeName': 'Alessia', 'Initials': 'A', 'LastName': 'Barisani', 'Affiliation': 'Dermatology, Department of Experimental, Diagnostic and Specialty Medicine, University of Bologna, Bologna, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Messori', 'Affiliation': 'Dermatology, Department of Experimental, Diagnostic and Specialty Medicine, University of Bologna, Bologna, Italy.'}, {'ForeName': 'Annalisa', 'Initials': 'A', 'LastName': 'Patrizi', 'Affiliation': 'Dermatology, Department of Experimental, Diagnostic and Specialty Medicine, University of Bologna, Bologna, Italy.'}, {'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Bardazzi', 'Affiliation': 'Dermatology, Department of Experimental, Diagnostic and Specialty Medicine, University of Bologna, Bologna, Italy.'}, {'ForeName': 'Sabina', 'Initials': 'S', 'LastName': 'Vaccari', 'Affiliation': 'Dermatology, Department of Experimental, Diagnostic and Specialty Medicine, University of Bologna, Bologna, Italy.'}]",Journal der Deutschen Dermatologischen Gesellschaft = Journal of the German Society of Dermatology : JDDG,['10.1111/ddg.14004'] 1441,32430108,Early Point-of-Care Ultrasound Assessment for Medical Patients Reduces Time to Appropriate Treatment: A Pilot Randomized Controlled Trial.,"Numerous studies emphasize the diagnostic importance of point-of-care ultrasound (POCUS), but the level of evidence remains low as most data are gathered from observational studies. We conducted a pilot, randomized controlled trial to evaluate the effect of POCUS exam on medical patient's management and clinical outcomes. Patients presenting with chest pain or dyspnea were enrolled and randomly allocated to an early POCUS scan group and a control group. POCUS assessment, within 24 h of internal ward admission, was conducted only for the intervention group. The primary outcome was time to correct diagnosis. Secondary outcomes included time to appropriate treatment, POCUS-related rate of primary diagnosis alteration and new clinically relevant findings and time to hospital discharge. Sixty patients were enrolled. Thirty patients were randomly allocated to each study arm. The POCUS exam revealed clinically relevant findings among 79% of patients and led to alteration of the primary diagnosis among 28% of patients. Time to appropriate treatment was significantly shorter among patients in the POCUS group compared with the control group (median time of 5 h [95% confidence interval: 0.5-9] vs. 24 h [95% CI: 19-29] p = 0.014). The time needed to achieve correct diagnosis by the primary team was shorter in the POCUS group compared with the control group, yet it did not reach statistical significance (median time of 24 h [95% CI: 18-30] vs. 48 h [95% CI: 20-76], p = 0.12). These results indicate that POCUS assessment conducted early among patients with dyspnea or chest pain improves diagnostic accuracy and shortens significantly the time to appropriate treatment.",2020,"The time needed to achieve correct diagnosis by the primary team was shorter in the POCUS group compared with the control group, yet it did not reach statistical significance (median time of 24 h [95% CI: 18-30] vs. 48 h [95% CI: 20-76], p = 0.12).","['Medical Patients Reduces Time to Appropriate Treatment', 'Sixty patients were enrolled', 'Thirty patients', 'Patients presenting with chest pain or dyspnea']","['early POCUS scan group and a control group', 'POCUS exam']","['time to appropriate treatment, POCUS-related rate of primary diagnosis alteration and new clinically relevant findings and time to hospital discharge', 'diagnostic accuracy', 'time needed to achieve correct diagnosis', 'time to correct diagnosis']","[{'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0008031', 'cui_str': 'Chest pain'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}]","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0282664', 'cui_str': 'Point-of-Care'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0582103', 'cui_str': 'Medical assessment'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0282664', 'cui_str': 'Point-of-Care'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0332137', 'cui_str': 'Principal diagnosis'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0586003', 'cui_str': 'Discharge from hospital'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}]",60.0,0.175229,"The time needed to achieve correct diagnosis by the primary team was shorter in the POCUS group compared with the control group, yet it did not reach statistical significance (median time of 24 h [95% CI: 18-30] vs. 48 h [95% CI: 20-76], p = 0.12).","[{'ForeName': 'Yael', 'Initials': 'Y', 'LastName': 'Ben-Baruch Golan', 'Affiliation': 'Internal Medicine Division, Soroka University Medical Center, Beer-Sheva, Israel. Electronic address: golany860@gmail.com.'}, {'ForeName': ""Re'em"", 'Initials': 'R', 'LastName': 'Sadeh', 'Affiliation': 'Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel; Clinical Research Center, Soroka University Medical Center, Beer-Sheva, Israel.'}, {'ForeName': 'Yuval', 'Initials': 'Y', 'LastName': 'Mizrakli', 'Affiliation': 'Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel; Clinical Research Center, Soroka University Medical Center, Beer-Sheva, Israel.'}, {'ForeName': 'Tali', 'Initials': 'T', 'LastName': 'Shafat', 'Affiliation': 'Internal Medicine Division, Soroka University Medical Center, Beer-Sheva, Israel; Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel.'}, {'ForeName': 'Iftach', 'Initials': 'I', 'LastName': 'Sagy', 'Affiliation': 'Internal Medicine Division, Soroka University Medical Center, Beer-Sheva, Israel; Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel.'}, {'ForeName': 'Tzachi', 'Initials': 'T', 'LastName': 'Slutsky', 'Affiliation': 'Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel; Emergency Department, Soroka University Medical Center, Beer-Sheva, Israel.'}, {'ForeName': 'Sergio L', 'Initials': 'SL', 'LastName': 'Kobal', 'Affiliation': 'Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel; Cardiology Department, Soroka University Medical Center, Beer-Sheva, Israel.'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Novack', 'Affiliation': 'Internal Medicine Division, Soroka University Medical Center, Beer-Sheva, Israel; Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel; Clinical Research Center, Soroka University Medical Center, Beer-Sheva, Israel.'}, {'ForeName': 'Lior', 'Initials': 'L', 'LastName': 'Fuchs', 'Affiliation': 'Internal Medicine Division, Soroka University Medical Center, Beer-Sheva, Israel; Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel.'}]",Ultrasound in medicine & biology,['10.1016/j.ultrasmedbio.2020.03.023'] 1442,29657029,The Hormone FGF21 Stimulates Water Drinking in Response to Ketogenic Diet and Alcohol.,"Alcohol and ketogenic diets increase water consumption. Here, we show that the hormone FGF21 is required for this drinking response in mice. Circulating levels of FGF21 are increased by alcohol consumption in humans and by both alcohol and ketogenic diets in mice. Pharmacologic administration of FGF21 stimulates water drinking behavior in mice within 2 hr. Concordantly, mice lacking FGF21 fail to increase water intake in response to either alcohol or a ketogenic diet. The effect of FGF21 on drinking is mediated in part by SIM1-positive neurons of the hypothalamus and is inhibited by β-adrenergic receptor antagonists. Given that FGF21 also is known to suppress alcohol intake in favor of pure water, this work identifies FGF21 as a fundamental neurotropic hormone that governs water balance in response to specific nutrient stresses that can cause dehydration.",2018,"Concordantly, mice lacking FGF21 fail to increase water intake in response to either alcohol or a ketogenic diet.",[],"['FGF21', 'Alcohol and ketogenic diets']",[],[],"[{'cui': 'C0972232', 'cui_str': 'fibroblast growth factor 21'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0259972', 'cui_str': 'Ketogenic Diet'}]",[],,0.0118931,"Concordantly, mice lacking FGF21 fail to increase water intake in response to either alcohol or a ketogenic diet.","[{'ForeName': 'Parkyong', 'Initials': 'P', 'LastName': 'Song', 'Affiliation': 'Department of Pharmacology, UT Southwestern Medical Center, Dallas, TX 75390, USA.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Zechner', 'Affiliation': 'Department of Pharmacology, UT Southwestern Medical Center, Dallas, TX 75390, USA; Department of Internal Medicine, UT Southwestern Medical Center, Dallas, TX 75390, USA; Charles and Jane Pak Center for Mineral Metabolism and Clinical Research, UT Southwestern Medical Center, Dallas, TX 75390, USA.'}, {'ForeName': 'Genaro', 'Initials': 'G', 'LastName': 'Hernandez', 'Affiliation': 'Department of Pharmacology, UT Southwestern Medical Center, Dallas, TX 75390, USA.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Cánovas', 'Affiliation': 'Departments of Biochemistry and Molecular Biophysics and Neuroscience, Columbia College of Physicians and Surgeons, Columbia University, New York, NY 10032, USA.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Xie', 'Affiliation': 'Department of Clinical Sciences, UT Southwestern Medical Center, Dallas, TX 75390, USA.'}, {'ForeName': 'Varun', 'Initials': 'V', 'LastName': 'Sondhi', 'Affiliation': 'Department of Pharmacology, UT Southwestern Medical Center, Dallas, TX 75390, USA; Department of Internal Medicine, UT Southwestern Medical Center, Dallas, TX 75390, USA.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Wagner', 'Affiliation': 'Department of Gastroenterology and Hepatology, Medical University of Graz, 8036 Graz, Austria.'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Stadlbauer', 'Affiliation': 'Department of Gastroenterology and Hepatology, Medical University of Graz, 8036 Graz, Austria.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Horvath', 'Affiliation': 'Department of Transplantation Surgery, Medical University of Graz, 8036 Graz, Austria; Center for Biomarker Research in Medicine (CBmed), 8010 Graz, Austria.'}, {'ForeName': 'Bettina', 'Initials': 'B', 'LastName': 'Leber', 'Affiliation': 'Department of Transplantation Surgery, Medical University of Graz, 8036 Graz, Austria; Center for Biomarker Research in Medicine (CBmed), 8010 Graz, Austria.'}, {'ForeName': 'Ming Chang', 'Initials': 'MC', 'LastName': 'Hu', 'Affiliation': 'Department of Internal Medicine, UT Southwestern Medical Center, Dallas, TX 75390, USA; Charles and Jane Pak Center for Mineral Metabolism and Clinical Research, UT Southwestern Medical Center, Dallas, TX 75390, USA.'}, {'ForeName': 'Orson W', 'Initials': 'OW', 'LastName': 'Moe', 'Affiliation': 'Department of Internal Medicine, UT Southwestern Medical Center, Dallas, TX 75390, USA; Charles and Jane Pak Center for Mineral Metabolism and Clinical Research, UT Southwestern Medical Center, Dallas, TX 75390, USA; Department of Physiology, UT Southwestern Medical Center, Dallas, TX 75390, USA.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Mangelsdorf', 'Affiliation': 'Department of Pharmacology, UT Southwestern Medical Center, Dallas, TX 75390, USA; Howard Hughes Medical Institute, UT Southwestern Medical Center, Dallas, TX 75390, USA. Electronic address: davo.mango@utsouthwestern.edu.'}, {'ForeName': 'Steven A', 'Initials': 'SA', 'LastName': 'Kliewer', 'Affiliation': 'Department of Pharmacology, UT Southwestern Medical Center, Dallas, TX 75390, USA; Department of Molecular Biology, UT Southwestern Medical Center, Dallas, TX 75390, USA. Electronic address: steven.kliewer@utsouthwestern.edu.'}]",Cell metabolism,['10.1016/j.cmet.2018.04.001'] 1443,19619377,"The project ENABLE II randomized controlled trial to improve palliative care for rural patients with advanced cancer: baseline findings, methodological challenges, and solutions.","OBJECTIVE There is a paucity of randomized controlled trials (RCTs) to evaluate models of palliative care. Although interventions vary, all have faced a variety of methodological challenges including adequate recruitment, missing data, and contamination of the control group. We describe the ENABLE II intervention, methods, and sample baseline characteristics to increase intervention and methodological transparency, and to describe our solutions to selected methodological issues. METHODS Half of the participants recruited from our rural U.S. comprehensive cancer center and affiliated clinics were randomly assigned to a phone-based, nurse-led educational, care coordination palliative care intervention model. Intervention services were provided to half of the participants weekly for the first month and then monthly until death, including bereavement follow-up call to the caregiver. The other half of the participants were assigned to care as usual. Symptoms, quality of life, mood, and functional status were assessed every 3 months until death. RESULTS Baseline data of 279 participants were similar to normative samples. Solutions to methodological challenges of recruitment, missing data, and ""usual care"" control group contamination are described. SIGNIFICANCE OF RESULTS It is feasible to overcome many of the methodological challenges to conducting a rigorous palliative care RCT.",2009,"Intervention services were provided to half of the participants weekly for the first month and then monthly until death, including bereavement follow-up call to the caregiver.","['rural patients with advanced cancer', '279 participants were similar to normative samples', 'participants recruited from our rural U.S. comprehensive cancer center and affiliated clinics']","['palliative care', 'phone-based, nurse-led educational, care coordination palliative care intervention model']","['Symptoms, quality of life, mood, and functional status']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}]","[{'cui': 'C0700049', 'cui_str': 'Palliative care'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0242414', 'cui_str': 'Coordination (observable entity)'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0034380'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}]",279.0,0.0590819,"Intervention services were provided to half of the participants weekly for the first month and then monthly until death, including bereavement follow-up call to the caregiver.","[{'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Bakitas', 'Affiliation': 'Department of Anesthesiology, Dartmouth Medical School, Hanover, New Hampshire 03756, USA. marie.bakitas@dartmouth.edu'}, {'ForeName': 'Kathleen Doyle', 'Initials': 'KD', 'LastName': 'Lyons', 'Affiliation': ''}, {'ForeName': 'Mark T', 'Initials': 'MT', 'LastName': 'Hegel', 'Affiliation': ''}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Balan', 'Affiliation': ''}, {'ForeName': 'Kathleen N', 'Initials': 'KN', 'LastName': 'Barnett', 'Affiliation': ''}, {'ForeName': 'Frances C', 'Initials': 'FC', 'LastName': 'Brokaw', 'Affiliation': ''}, {'ForeName': 'Ira R', 'Initials': 'IR', 'LastName': 'Byock', 'Affiliation': ''}, {'ForeName': 'Jay G', 'Initials': 'JG', 'LastName': 'Hull', 'Affiliation': ''}, {'ForeName': 'Zhongze', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'McKinstry', 'Affiliation': ''}, {'ForeName': 'Janette L', 'Initials': 'JL', 'LastName': 'Seville', 'Affiliation': ''}, {'ForeName': 'Tim A', 'Initials': 'TA', 'LastName': 'Ahles', 'Affiliation': ''}]",Palliative & supportive care,['10.1017/S1478951509000108'] 1444,32069467,"Effectiveness of an Adjunctive Psychotherapeutic Intervention Developed for Enhancing the Placebo Effect of Antidepressants Used within an Inpatient-Treatment Program of Major Depression: A Pragmatic Parallel-Group, Randomized Controlled Trial.",,2020,,['Major Depression'],['Adjunctive Psychotherapeutic Intervention'],[],"[{'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}]",[],[],,0.0681857,,"[{'ForeName': 'Benedikt Bernd', 'Initials': 'BB', 'LastName': 'Claus', 'Affiliation': 'Department of Psychiatry, Psychotherapy and Psychosomatic Medicine, Evangelisches Krankenhaus Castrop-Rauxel, Academic Teaching Hospital of the University of Duisburg-Essen, Castrop-Rauxel, Germany.'}, {'ForeName': 'Norbert', 'Initials': 'N', 'LastName': 'Scherbaum', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Faculty of Medicine, LVR-Hospital Essen, University of Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Udo', 'Initials': 'U', 'LastName': 'Bonnet', 'Affiliation': 'Department of Psychiatry, Psychotherapy and Psychosomatic Medicine, Evangelisches Krankenhaus Castrop-Rauxel, Academic Teaching Hospital of the University of Duisburg-Essen, Castrop-Rauxel, Germany, udo.bonnet@uni-due.de.'}]",Psychotherapy and psychosomatics,['10.1159/000505855'] 1445,32432326,"Intrauterine insemination performance characteristics and post-processing total motile sperm count in relation to live birth for couples with unexplained infertility in a randomised, multicentre clinical trial.","STUDY QUESTION Are intrauterine insemination (IUI) performance characteristics and post-processing total motile sperm count (TMC) related to live birth rate in couples with unexplained infertility? SUMMARY ANSWER Patient discomfort with IUI and lower inseminate TMC were associated with a reduced live birth rate, while time from hCG injection to IUI, sperm preparation method and ultrasound guidance for IUI were not associated with live birth success. WHAT IS ALREADY KNOWN We previously determined that some baseline characteristics of couples with unexplained infertility, including female age, duration of infertility, history of prior loss and income, were related to live birth rate across a course of ovarian stimulation and IUI treatment. However, the relationship between treatment outcomes and per-cycle characteristics, including ultrasound guidance for IUI, timing of IUI relative to hCG injection, difficult or painful IUI and inseminate TMC, are controversial, and most prior investigations have not evaluated live birth outcome. STUDY DESIGN, SIZE, DURATION This was a secondary analyses of 2462 cycles from the Assessment of Multiple Intrauterine Gestations from Ovarian Stimulation (AMIGOS) clinical trial. This prospective, randomised, multicentre clinical trial determined live birth rates following IUI after ovarian stimulation with clomiphene citrate, letrozole or gonadotropins in 854 couples with unexplained infertility. It was conducted between 2011 and 2014, and couples could undergo up to four consecutive treatment cycles. PARTICIPANTS/MATERIALS, SETTING, METHODS AMIGOS was an NIH-sponsored Reproductive Medicine Network trial conducted at 12 clinical sites. Participants were women with unexplained infertility who were between 18 and 40 years of age. Cluster-weighted generalised estimating equations (GEE), which account for informative clustering of multiple IUI treatment cycles within the same patient, were used to determine associations between IUI performance characteristics, including inseminate TMC, and live birth rate. Efficiency curves were also generated to examine the relationship between inseminate TMC and live birth rate. MAIN RESULTS AND THE ROLE OF CHANCE After adjustment for treatment group and baseline factors previously associated with live birth across a course of OS-IUI treatment, patient discomfort during the IUI procedure was associated with a reduction in live birth rate (aRR 0.40 (0.16-0.96)). Time from hCG trigger injection to IUI was not significantly associated with outcome. Higher TMC was associated with greater live birth rate (TMC 15.1-20.0 million (14.8%) compared to ≤5 million (5.5%)) (aRR 2.09 (1.31-3.33)). However, live births did occur with TMC ≤ 1 million (5.1%). LIMITATIONS, REASONS FOR CAUTION This investigation is a secondary analysis, and AMIGOS was not designed to address the present question. Since timed intercourse was allowed as part of the AMIGOS trial, we cannot rule out the possibility that any given pregnancy resulted from intercourse rather than IUI. WIDER IMPLICATIONS OF THE FINDINGS Most factors associated with the performance of IUI were not significantly related to obtaining live birth. Our findings suggest that higher TMC inseminated leads to an increase in live birth rate up to TMC ~20 million. However, there may be no reasonable threshold below which live birth is not possible with IUI. STUDY FUNDING/COMPETING INTEREST(S) Funding was received through grants from the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): U10 HD077680, U10 HD39005, U10 HD38992, U10 HD27049, U10 HD38998, U10 HD055942, HD055944, U10 HD055936 and U10 HD055925. This research was made possible by funding by the American Recovery and Reinvestment Act. Dr Hansen reports grants from NIH/NICHD and Yale University during the conduct of the study, grants from Roche Diagnostics and grants from Ferring International Pharmascience Center US outside the submitted work. Dr Peck reports support from Ferring Pharmaceuticals outside the submitted work. Dr Coward has nothing to disclose. Dr Wild reports grants from NICHD during the conduct of the study. Dr Trussell has nothing to disclose. Dr Krawetz reports grants from NICHD during the conduct of the study, grants from Merck and support from Taylor and Frances and from Springer, outside the submitted work. Dr Diamond reports grants from NIH/NICHD, Yale University, during the conduct of the study and support from Advanced Reproductive Care AbbVie, Bayer and ObsEva, outside the submitted work. Dr Legro reports support from Bayer, Kindex, Odega, Millendo and AbbVie and grants and support from Ferring, outside the submitted work. Dr Coutifaris reports grants from NICHD/NIH and personal fees from American Society for Reproductive Medicine, outside the submitted work. Dr Alvero has nothing to disclose. Dr Robinson reports grants from NIH during the conduct of the study. Dr Casson has nothing to disclose. Dr Christman reports grants from NICHD during the conduct of the study. Dr Santoro reports grants from NIH during the conduct of the study. Dr Zhang reports grants from NIH during the conduct of the study and support from Shangdong University outside the submitted work. TRIAL REGISTRATION NUMBER n/a.",2020,"SUMMARY ANSWER Patient discomfort with IUI and lower inseminate TMC were associated with a reduced live birth rate, while time from hCG injection to IUI, sperm preparation method and ultrasound guidance for IUI were not associated with live birth success. ","['Participants were women with unexplained infertility who were between 18 and 40\xa0years of age', 'AMIGOS was an NIH-sponsored Reproductive Medicine Network trial conducted at 12 clinical sites', '854 couples with unexplained infertility', '2462\xa0cycles from the Assessment of Multiple Intrauterine Gestations from Ovarian Stimulation (AMIGOS) clinical trial', '2011 and 2014, and couples could undergo up to four consecutive treatment cycles', 'couples with unexplained infertility']","['intrauterine insemination (IUI) performance characteristics and post-processing total motile sperm count (TMC', 'clomiphene citrate, letrozole or gonadotropins', 'Intrauterine insemination performance characteristics and post-processing total motile sperm count']","['live birth across a course of OS-IUI treatment, patient discomfort', 'live birth rate', 'ultrasound guidance for IUI, timing of IUI relative to hCG injection, difficult or painful IUI and inseminate TMC']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0404585', 'cui_str': 'Unexplained infertility'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0694756', 'cui_str': 'Intrauterine'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0949385', 'cui_str': 'Ovarian Stimulation'}, {'cui': 'C0027468', 'cui_str': 'United States National Institutes of Health'}, {'cui': 'C0242668', 'cui_str': 'Medicine, Reproductive'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0546824', 'cui_str': 'Intrauterine artificial insemination'}, {'cui': 'C0449935', 'cui_str': 'Post-processing'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0577264', 'cui_str': 'Sperm motile'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0546859', 'cui_str': 'Clomiphene citrate'}, {'cui': 'C0246421', 'cui_str': 'letrozole'}, {'cui': 'C0018061', 'cui_str': 'Gonadotropin'}]","[{'cui': 'C0481667', 'cui_str': 'Live birth'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0546824', 'cui_str': 'Intrauterine artificial insemination'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0442973', 'cui_str': 'Ultrasonic guidance procedure'}, {'cui': 'C0449243', 'cui_str': 'Timing'}, {'cui': 'C3875154', 'cui_str': 'Relative to'}, {'cui': 'C1141639', 'cui_str': 'Human chorionic gonadotropin'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0332218', 'cui_str': 'Difficult'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0577264', 'cui_str': 'Sperm motile'}, {'cui': 'C0439157', 'cui_str': 'counts'}]",854.0,0.111279,"SUMMARY ANSWER Patient discomfort with IUI and lower inseminate TMC were associated with a reduced live birth rate, while time from hCG injection to IUI, sperm preparation method and ultrasound guidance for IUI were not associated with live birth success. ","[{'ForeName': 'Karl R', 'Initials': 'KR', 'LastName': 'Hansen', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Oklahoma College of Medicine, Oklahoma City, OK 73104, USA.'}, {'ForeName': 'Jennifer D', 'Initials': 'JD', 'LastName': 'Peck', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Oklahoma College of Medicine, Oklahoma City, OK 73104, USA.'}, {'ForeName': 'R Matthew', 'Initials': 'RM', 'LastName': 'Coward', 'Affiliation': 'Department of Urology, UNC School of Medicine, 2113 Physicians Office Building CB#7235, Chapel Hill, NC 27599-7235, USA.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Wild', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Oklahoma College of Medicine, Oklahoma City, OK 73104, USA.'}, {'ForeName': 'J C', 'Initials': 'JC', 'LastName': 'Trussell', 'Affiliation': 'Department of Urology, Upstate University Hospital, 750 East Adams Street, Syracuse, NY 13210, USA.'}, {'ForeName': 'Stephen A', 'Initials': 'SA', 'LastName': 'Krawetz', 'Affiliation': 'Department of Obstetrics and Gynecology and Molecular Medicine and Genetics, Wayne State University School of Medicine, Detroit, MI 48201, USA.'}, {'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'Diamond', 'Affiliation': 'Department of Obstetrics and Gynecology, Wayne State University School of Medicine, Detroit, MI 48201, USA.'}, {'ForeName': 'Richard S', 'Initials': 'RS', 'LastName': 'Legro', 'Affiliation': 'Department of Obstetrics and Gynecology, Pennsylvania State University, Hershey, PA 17033, USA.'}, {'ForeName': 'Christos', 'Initials': 'C', 'LastName': 'Coutifaris', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Pennsylvania, Philadelphia, PA 19104, USA.'}, {'ForeName': 'Ruben', 'Initials': 'R', 'LastName': 'Alvero', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Colorado Denver, Aurora, CO 80045, USA.'}, {'ForeName': 'Randal D', 'Initials': 'RD', 'LastName': 'Robinson', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Texas Health Science Center at San Antonio, TX 78229, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Casson', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Vermont, Burlington, VT 05446, USA.'}, {'ForeName': 'Gregory M', 'Initials': 'GM', 'LastName': 'Christman', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Michigan, Ann Arbor, MI 48109, USA.'}, {'ForeName': 'Nanette', 'Initials': 'N', 'LastName': 'Santoro', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Colorado Denver, Aurora, CO 80045, USA.'}, {'ForeName': 'Heping', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Department of Biostatistics, Yale University School of Public Health, New Haven, CT 06520, USA.'}]","Human reproduction (Oxford, England)",['10.1093/humrep/deaa027'] 1446,18408224,First-line bevacizumab combined with reduced dose interferon-alpha2a is active in patients with metastatic renal cell carcinoma.,"BACKGROUND In patients with untreated metastatic renal cell carcinoma (mRCC), progression-free survival (PFS) was longer with bevacizumab + interferon (IFN)-alpha than IFN + placebo (AVOREN trial). In this hypothesis-generating study, subgroup analysis was carried out to determine the effect of IFN dose reduction. PATIENTS AND METHODS A total of 649 patients received IFN 9 MIU s.c. three times weekly plus bevacizumab 10 mg/kg or placebo every 2 weeks until disease progression. The IFN dose was reduced to 6 or 3 MIU with the development of IFN-attributed toxicity. Differences between treatment arms in PFS, response rate and tolerability were analysed in the reduced-dose group. RESULTS IFN dose was reduced in 131 patients in the bevacizumab + IFN arm and 97 patients in the IFN + placebo arm during the trial. PFS rates in the bevacizumab + reduced-dose IFN group were comparable with the total population (Kaplan-Meier estimates of event-free rate at 1 year: 0.524 versus 0.427). Bevacizumab + reduced-dose IFN was well tolerated, with substantial decreases in the rate of adverse events following dose reduction. CONCLUSION This retrospective subgroup analysis suggests that the dose of IFN can be reduced to manage side-effects while maintaining efficacy in patients with mRCC receiving bevacizumab + IFN.",2008,PFS rates in the bevacizumab + reduced-dose IFN group were comparable with the total population (Kaplan-Meier estimates of event-free rate at 1 year: 0.524 versus 0.427).,"['patients with metastatic renal cell carcinoma', 'patients with untreated metastatic renal cell carcinoma (mRCC), progression-free survival (PFS) was longer with', 'patients with mRCC receiving', '649 patients received IFN 9 MIU s.c', '131 patients in the']","['placebo', 'bevacizumab', 'Bevacizumab', 'bevacizumab + interferon (IFN)-alpha than IFN + placebo', 'IFN + placebo', 'bevacizumab + IFN', 'interferon-alpha2a', 'IFN']","['rate of adverse events', 'PFS, response rate and tolerability', 'PFS rates']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0278678', 'cui_str': 'Metastatic renal cell carcinoma'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0439455', 'cui_str': 'mIU'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0002199', 'cui_str': 'Interferon, Lymphoblastoid'}, {'cui': 'C0021747', 'cui_str': 'Interferons'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}]",649.0,0.535037,PFS rates in the bevacizumab + reduced-dose IFN group were comparable with the total population (Kaplan-Meier estimates of event-free rate at 1 year: 0.524 versus 0.427).,"[{'ForeName': 'B', 'Initials': 'B', 'LastName': 'Melichar', 'Affiliation': 'Charles University Medical School and Teaching Hospital, Hradec Králové, Czech Republic. Electronic address: melichar@fnhk.cz.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Koralewski', 'Affiliation': 'Szpital im. Rydygiera, Krakow, Poland.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Ravaud', 'Affiliation': 'Department of Medical Oncology and Radiotherapy, Hôpital Saint André, CHU Bordeaux, Bordeaux, France.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Pluzanska', 'Affiliation': 'Klinika Chemioterapii AM, Lodz, Poland.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Bracarda', 'Affiliation': 'Department of Medical Oncology, Azienda Ospedaliera, Perugia, Italy.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Szczylik', 'Affiliation': 'Oncology Clinic, Wojskowy Instytut Medyczny, Warsaw, Poland.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Chevreau', 'Affiliation': 'Department of Medical Oncology, Institut Claudius-Regaud, Toulouse Cedex, France.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Filipek', 'Affiliation': 'Szpital Wojewodzki im. Sw. Lukasz, Tarnow, Poland.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Delva', 'Affiliation': 'Department of Medical Oncology, Centre Paul Papin, Angers.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Sevin', 'Affiliation': 'Centre Régional François Baclesse de Lutte contre le Cancer, Caen.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Négrier', 'Affiliation': 'Department of Medical Oncology, Centre Léon Bérard, Lyon, France.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'McKendrick', 'Affiliation': 'Department of Medical Oncology, Box Hill Hospital, Box Hill, Australia.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Santoro', 'Affiliation': 'Department of Oncology and Hematology, Istituto Clinico Humanitas, Rozzano, Italy.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Pisa', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Escudier', 'Affiliation': 'Department of Medicine, Institut Gustave Roussy, Villejuif, France.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdn161'] 1447,32432695,Coached Mobile App Platform for the Treatment of Depression and Anxiety Among Primary Care Patients: A Randomized Clinical Trial.,"Importance Depression and anxiety are common and disabling. Primary care is the de facto site for treating these mental health problems but is typically underresourced to meet the burden of these demands. Objective To evaluate the efficacy of a mobile intervention platform, IntelliCare, for addressing depression and anxiety among primary care patients. Design, Setting, and Participants Two-arm randomized clinical trial at internal medicine clinics at the University of Arkansas for Medical Sciences. Adult primary care patients (N = 146) who screened positive for depression on the Patient Health Questionnaire-8 (PHQ; score  ≥ 10) or anxiety on the Generalized Anxiety Disorder-7 (GAD-7; score ≥ 8) were recruited between July 17, 2018, and December 14, 2018. Interventions The coach-supported platform composed of a suite of apps, was delivered over 8 weeks. Wait list control participants received treatment as usual for 8 weeks, then the mobile platform. Main Outcomes and Measures Primary outcomes were changes in depression (PHQ-9) and anxiety (GAD-7) during the intervention period. Secondary outcomes were differences in the proportion of patients who achieved recovery (PHQ-9/GAD-7 <5 or 50% improvement from baseline), sustainment of intervention effects during 2-month follow-up, and app use during the intervention period. Results One hundred forty-six patients were included (119 of 146 were women [81.5%]; mean [SD] age, 42.3 [13.8] years). Of the 146 patients, 122 (83.6%) were diagnosed as having depression and 131 (89.7%) were diagnosed as having anxiety. A greater proportion of intervention vs wait list control participants achieved recovery from depression (n = 38 of 64 [59%] vs n = 18 of 58 [31%]; odds ratio, 3.25; 95% CI, 1.54-6.86) and anxiety (n = 37 of 65 [57%] vs n = 25 of 66 [38%]; odds ratio, 2.17; 95% CI, 1.08-4.36). Sustained effects were observed for depression (slope, 0.01; 95% CI, -0.09 to 0.10; P = .92) and anxiety scores (slope, 0.02; 95% CI, -0.08 to 0.12; P = .67) during follow-up. App use was high, with a median of 93 and 98 sessions among participants with depression and anxiety, respectively. Conclusions and Relevance In this trial, a mobile intervention app was effective for depression and anxiety among primary care patients. Findings also support designing digital mental health interventions as platforms containing simple, brief apps that can be bundled by users to meet their needs. Trial Registration ClinicalTrials.gov Identifier: NCT03500536.",2020,"To evaluate the efficacy of a mobile intervention platform, IntelliCare, for addressing depression and anxiety among primary care patients. ","['Adult primary care patients (N\u2009=\u2009146) who screened positive for depression on the Patient Health Questionnaire-8 (PHQ; score \u2009≥\u200910) or anxiety on the Generalized Anxiety Disorder-7 (GAD-7; score\u2009≥\u20098) were recruited between July 17, 2018, and December 14, 2018', 'Primary Care Patients', '146 patients, 122 (83.6%) were diagnosed as having depression and 131 (89.7%) were diagnosed as having anxiety', 'One hundred forty-six patients were included (119 of 146 were women [81.5', 'Participants\n\n\nTwo-arm randomized clinical trial at internal medicine clinics at the University of Arkansas for Medical Sciences', 'primary care patients']","['mobile intervention platform, IntelliCare', 'Coached Mobile App Platform']","['proportion of patients who achieved recovery (PHQ-9/GAD-7', 'anxiety', 'changes in depression (PHQ-9) and anxiety (GAD-7', 'anxiety scores', 'depression and anxiety']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C1879301', 'cui_str': 'PHQ Patient Health Questionnaire'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}, {'cui': 'C3641330', 'cui_str': 'GAD-7'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C3838887', 'cui_str': 'Internal medicine clinic'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0025118', 'cui_str': 'Medicine'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1879301', 'cui_str': 'PHQ Patient Health Questionnaire'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C3641330', 'cui_str': 'GAD-7'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",146.0,0.149203,"To evaluate the efficacy of a mobile intervention platform, IntelliCare, for addressing depression and anxiety among primary care patients. ","[{'ForeName': 'Andrea K', 'Initials': 'AK', 'LastName': 'Graham', 'Affiliation': 'Center for Behavioral Intervention Technologies, Northwestern University, Chicago, Illinois.'}, {'ForeName': 'Carolyn J', 'Initials': 'CJ', 'LastName': 'Greene', 'Affiliation': 'Psychiatric Research Institute, University of Arkansas for Medical Sciences, Little Rock.'}, {'ForeName': 'Mary J', 'Initials': 'MJ', 'LastName': 'Kwasny', 'Affiliation': 'Center for Behavioral Intervention Technologies, Northwestern University, Chicago, Illinois.'}, {'ForeName': 'Susan M', 'Initials': 'SM', 'LastName': 'Kaiser', 'Affiliation': 'Center for Behavioral Intervention Technologies, Northwestern University, Chicago, Illinois.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Lieponis', 'Affiliation': 'Actualize Therapy, Inc, Chicago, Illinois.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Powell', 'Affiliation': 'Department of Biomedical Informatics, University of Arkansas for Medical Sciences, Little Rock.'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Mohr', 'Affiliation': 'Center for Behavioral Intervention Technologies, Northwestern University, Chicago, Illinois.'}]",JAMA psychiatry,['10.1001/jamapsychiatry.2020.1011'] 1448,32007610,"Pilonidal sinus disease: If many methods stand time's test, the best may mirror all the rest. A commentary on: ""Long-term results of a randomized clinical trial comparing endoscopic versus conventional treatment of pilonidal sinus"" [Int. J. Surg. 2020;74:81-5].",,2020,,[],[],[],[],[],[],,0.0191392,,"[{'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Beamish', 'Affiliation': 'Department of Gastrosurgical Research and Education, Institute of Clinical Sciences, Gothenburg University, Gothenburg, 41345, Sweden. Electronic address: beamishaj@gmail.com.'}]","International journal of surgery (London, England)",['10.1016/j.ijsu.2020.01.134'] 1449,31461138,Effect of Low-Dose Supplementation of Arginine Vasopressin on Need for Blood Product Transfusions in Patients With Trauma and Hemorrhagic Shock: A Randomized Clinical Trial.,"Importance Current therapies for traumatic blood loss focus on hemorrhage control and blood volume replacement. Severe hemorrhagic shock, however, is associated with a state of arginine vasopressin (AVP) deficiency, and supplementation of this hormone may decrease the need for blood products in resuscitation. Objective To determine whether low-dose supplementation of AVP in patients with trauma (hereinafter referred to as trauma patients) and with hemorrhagic shock decreases their need for transfused blood products during resuscitation. Design, Setting, and Participants This randomized, double-blind placebo-controlled clinical trial included adult trauma patients (aged 18-65 years) who received at least 6 U of any blood product within 12 hours of injury at a single urban level 1 trauma center from May 1, 2013, through May 31, 2017. Exclusion criteria consisted of prehospital cardiopulmonary resuscitation, emergency department thoracotomy, corticosteroid use, chronic renal insufficiency, coronary artery disease, traumatic brain injury requiring any neurosurgical intervention, pregnancy, prisoner status, or AVP administration before enrollment. Data were analyzed from May 1, 2013, through May 31, 2017, using intention to treat and per protocol. Interventions After administration of an AVP bolus (4 U) or placebo, participants received AVP (≤0.04 U/min) or placebo for 48 hours to maintain a mean arterial blood pressure of at least 65 mm Hg. Main Outcomes The primary outcome was total volume of blood product transfused. Secondary end points included total volume of crystalloid transfused, vasopressor requirements, secondary complications, and 30-day mortality. Results One hundred patients underwent randomization (49 to the AVP group and 51 to the placebo group). Patients were primarily young (median age, 27 years [interquartile range {IQR}, 22-25 years]) and male (n = 93) with penetrating trauma (n = 79). Cohort characteristics before randomization were well balanced. At 48 hours, patients who received AVP required significantly less blood products (median, 1.4 [IQR, 0.5-2.6] vs 2.9 [IQR, 1.1-4.8] L; P = .01) but did not differ in requirements for crystalloids (median, 9.9 [IQR, 7.9-13.0] vs 11.0 [8.9-15.0] L; P = .22) or vasopressors (median, 400 [IQR, 0-5900] vs 1400 [IQR, 200-7600] equivalent units; P = .22). Although the groups had similar rates of mortality (6 of 49 [12%] vs 6 of 51 [12%]; P = .94) and total complications (24 of 44 [55%] vs 30 of 47 [64%]; P = .37), the AVP group had less deep venous thrombosis (5 of 44 [11%] vs 16 of 47 [34%]; P = .02). Conclusions and Relevance Low-dose AVP during the resuscitation of trauma patients in hemorrhagic shock decreases blood product requirements. Additional research is necessary to determine whether including AVP improves morbidity or mortality. Trial Registration ClinicalTrials.gov identifier: NCT01611935.",2019,"At 48 hours, patients who received AVP required significantly less blood products (median, 1.4 [IQR, 0.5-2.6] vs 2.9 [IQR, 1.1-4.8] L; P = .01) but did not differ in requirements for crystalloids (median, 9.9 [IQR, 7.9-13.0] vs 11.0 [8.9-15.0] L; P = .22) or vasopressors (median, 400 [IQR, 0-5900] vs 1400 [IQR, 200-7600] equivalent units; P = .22).","['Patients With Trauma and Hemorrhagic Shock', 'patients with trauma', 'adult trauma patients (aged 18-65 years) who received at least 6 U of any blood product within 12 hours of injury at a single urban level 1 trauma center from May 1, 2013, through May 31, 2017', 'Exclusion criteria consisted of prehospital cardiopulmonary resuscitation, emergency department thoracotomy, corticosteroid use, chronic renal insufficiency, coronary artery disease, traumatic brain injury requiring any neurosurgical intervention, pregnancy, prisoner status, or AVP administration before enrollment', 'Patients were primarily young (median age, 27 years [interquartile range {IQR}, 22-25 years]) and male (n\u2009=\u200993) with penetrating trauma (n\u2009=\u200979', 'One hundred patients underwent randomization (49 to the AVP group and 51 to the']","['AVP bolus (4 U) or placebo', 'AVP (≤0.04 U/min) or placebo', 'AVP', 'placebo', 'Arginine Vasopressin']","['Severe hemorrhagic shock', 'total complications', 'Blood Product Transfusions', 'total volume of crystalloid transfused, vasopressor requirements, secondary complications, and 30-day mortality', 'total volume of blood product transfused', 'deep venous thrombosis', 'rates of mortality', 'blood products']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0043251', 'cui_str': 'Trauma'}, {'cui': 'C0036982', 'cui_str': 'Shock, Hemorrhagic'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0456388', 'cui_str': 'Blood product (product)'}, {'cui': 'C1292430', 'cui_str': '12 hours'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0456947', 'cui_str': 'Level 1 (qualifier value)'}, {'cui': 'C0040786', 'cui_str': 'Trauma Centers'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0007203', 'cui_str': 'Cardio-Pulmonary Resuscitation'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0039991', 'cui_str': 'Thoracotomy'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0403447', 'cui_str': 'Renal Insufficiency, Chronic'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}, {'cui': 'C0876926', 'cui_str': 'TBI (Traumatic Brain Injury)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0033167', 'cui_str': 'Prisoners'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0205321', 'cui_str': 'Penetrating (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1532693', 'cui_str': 'Units per minute'}, {'cui': 'C0003779', 'cui_str': 'Argipressin'}]","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0036982', 'cui_str': 'Shock, Hemorrhagic'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0005841', 'cui_str': 'Blood Transfusion'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0056562', 'cui_str': 'Crystalloid'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0456388', 'cui_str': 'Blood product (product)'}, {'cui': 'C0149871', 'cui_str': 'Deep Vein Thrombosis'}]",100.0,0.742006,"At 48 hours, patients who received AVP required significantly less blood products (median, 1.4 [IQR, 0.5-2.6] vs 2.9 [IQR, 1.1-4.8] L; P = .01) but did not differ in requirements for crystalloids (median, 9.9 [IQR, 7.9-13.0] vs 11.0 [8.9-15.0] L; P = .22) or vasopressors (median, 400 [IQR, 0-5900] vs 1400 [IQR, 200-7600] equivalent units; P = .22).","[{'ForeName': 'Carrie A', 'Initials': 'CA', 'LastName': 'Sims', 'Affiliation': 'Division of Traumatology, Surgical Critical Care, and Emergency Surgery, Department of Surgery, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Holena', 'Affiliation': 'Division of Traumatology, Surgical Critical Care, and Emergency Surgery, Department of Surgery, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Kim', 'Affiliation': 'Division of Traumatology, Surgical Critical Care, and Emergency Surgery, Department of Surgery, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Pascual', 'Affiliation': 'Division of Traumatology, Surgical Critical Care, and Emergency Surgery, Department of Surgery, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Smith', 'Affiliation': 'Division of Traumatology, Surgical Critical Care, and Emergency Surgery, Department of Surgery, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Neils', 'Initials': 'N', 'LastName': 'Martin', 'Affiliation': 'Division of Traumatology, Surgical Critical Care, and Emergency Surgery, Department of Surgery, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Seamon', 'Affiliation': 'Division of Traumatology, Surgical Critical Care, and Emergency Surgery, Department of Surgery, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Shiroff', 'Affiliation': 'Division of Traumatology, Surgical Critical Care, and Emergency Surgery, Department of Surgery, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Shariq', 'Initials': 'S', 'LastName': 'Raza', 'Affiliation': 'Division of Traumatology, Surgical Critical Care, and Emergency Surgery, Department of Surgery, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Lewis', 'Initials': 'L', 'LastName': 'Kaplan', 'Affiliation': 'Division of Traumatology, Surgical Critical Care, and Emergency Surgery, Department of Surgery, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Grill', 'Affiliation': 'Division of Traumatology, Surgical Critical Care, and Emergency Surgery, Department of Surgery, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Zimmerman', 'Affiliation': 'Department of Quantitative Health Sciences and Outcomes Research, Cleveland Clinic Foundation, Cleveland, Ohio.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Mason', 'Affiliation': 'Department of Anesthesia, Perelman School of Medicine, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Abella', 'Affiliation': 'Department of Emergency Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Reilly', 'Affiliation': 'Division of Traumatology, Surgical Critical Care, and Emergency Surgery, Department of Surgery, University of Pennsylvania, Philadelphia.'}]",JAMA surgery,['10.1001/jamasurg.2019.2884'] 1450,32428843,Aquatic exercising may improve sexual function in females with multiple sclerosis - an exploratory study.,"BACKGROUND Persons with multiple sclerosis (PwMS) report impaired sexual function, and this is particularly prevalent and burdensome for females with MS. The present study included a randomized controlled trial (RCT) design and examined the effect of aquatic exercise training on sexual function among females with MS. METHODS The sample consisted of 60 married female PwMS (mean age: 37.68 years; median EDSS: 1.75) who were randomly assigned into one of the following conditions: aquatic exercise twice a week (2x/w); aquatic exercise three times a week (3x/w); active control condition (ACC). Participants completed questionnaires regarding sexual function (desire, arousal, lubrication, orgasm, satisfaction, pain), symptoms of depression, sleep complaints, fatigue, and couple satisfaction before and after the 8-week study period. RESULTS The interventions had significant and positive effects on the overall score of sexual function (p < .001, η ρ 2 = .35), all subscales (desire (p = .002, 2 = .20), arousal (p = .01, 2 =.15), lubrication (p = .011, 2 = .15), orgasm (p = .007, 2 = .16), satisfaction (p = .023, 2 = .13), pain (p = .02, 2 = .13)) and depression (p =.002, 2 = .20).The interventions had no significant and positive effects on fatigue (p = .31, 2 = .04) sleep complaints (p = .079, 2= .087), and couple satisfaction (p = .69, 2 = .01) compared with the active control condition. CONCLUSIONS Aquatic exercise training may improve sexual function among female PwMS, but this requires further examination using a large sample pre-screened for sexual dysfunction. If confirmed, the present findings are of clinical and practical importance for females with MS.",2020,"interventions had no significant and positive effects on fatigue (p = .31, 2 = .04) sleep complaints (p = .079, 2= .087), and couple satisfaction (p = .69, 2 = .01) compared with the active control condition. ","['Persons with multiple sclerosis (PwMS', 'females with multiple sclerosis', 'females with MS.\nMETHODS', 'females with MS', '60 married female PwMS (mean age: 37.68 years; median EDSS: 1.75']","['Aquatic exercise training', 'aquatic exercise twice a week (2x/w); aquatic exercise three times a week (3x/w); active control condition (ACC', 'aquatic exercise training', 'Aquatic exercising']","['arousal', 'overall score of sexual function', 'fatigue', 'sleep complaints', 'couple satisfaction', 'questionnaires regarding sexual function (desire, arousal, lubrication, orgasm, satisfaction, pain), symptoms of depression, sleep complaints, fatigue, and couple satisfaction', 'sexual function', 'satisfaction', 'pain', 'depression', 'lubrication']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0024841', 'cui_str': 'Marriage'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0451246', 'cui_str': 'Kurtzke multiple sclerosis rating scale'}, {'cui': 'C4517514', 'cui_str': '1.75'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0556985', 'cui_str': 'Twice weekly'}, {'cui': 'C0556987', 'cui_str': 'Three times weekly'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0278092', 'cui_str': 'Sexual function'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0277786', 'cui_str': 'Complaint'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0024069', 'cui_str': 'Lubrication'}, {'cui': 'C0029260', 'cui_str': 'Sexual orgasm'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]",60.0,0.044883,"interventions had no significant and positive effects on fatigue (p = .31, 2 = .04) sleep complaints (p = .079, 2= .087), and couple satisfaction (p = .69, 2 = .01) compared with the active control condition. ","[{'ForeName': 'Dena', 'Initials': 'D', 'LastName': 'Sadeghi Bahmani', 'Affiliation': 'University of Basel, Psychiatric Clinics (UPK), Center of Affective, Stress and Sleep Disorders (ZASS), Basel, Switzerland; Departments of Physical Therapy, University of Alabama at Birmingham, Birmingham, Alabama, USA; Kermanshah University of Medical Sciences (KUMS), Sleep Disorders Research Center, Kermanshah, Iran. Electronic address: dena.sadeghibahmani@upk.ch.'}, {'ForeName': 'Robert W', 'Initials': 'RW', 'LastName': 'Motl', 'Affiliation': 'Departments of Physical Therapy, University of Alabama at Birmingham, Birmingham, Alabama, USA.'}, {'ForeName': 'Nazanin', 'Initials': 'N', 'LastName': 'Razazian', 'Affiliation': 'Kermanshah University of Medical Sciences, Neurology Department, Kermanshah, Iran.'}, {'ForeName': 'Habibolah', 'Initials': 'H', 'LastName': 'Khazaie', 'Affiliation': 'Kermanshah University of Medical Sciences (KUMS), Sleep Disorders Research Center, Kermanshah, Iran.'}, {'ForeName': 'Serge', 'Initials': 'S', 'LastName': 'Brand', 'Affiliation': 'University of Basel, Psychiatric Clinics (UPK), Center of Affective, Stress and Sleep Disorders (ZASS), Basel, Switzerland; Kermanshah University of Medical Sciences (KUMS), Sleep Disorders Research Center, Kermanshah, Iran; Kermanshah University of Medical Sciences (KUMS), Substance Abuse Prevention Research Center, Health Institute, Kermanshah, Iran; University of Basel, Department of Sport, Exercise, and Health, Division of Sport Science and Psychosocial Health, Basel, Switzerland; Tehran University of Medical Sciences, School of Medicine, Tehran, Iran.'}]",Multiple sclerosis and related disorders,['10.1016/j.msard.2020.102106'] 1451,32074616,Changes in Therapeutic Alliance and in Social Inhibition as Mediators of the Effect of the Cognitive Behavioral Analysis System of Psychotherapy: A Secondary Analysis from a Randomized Clinical Trial.,,2020,,[],['Psychotherapy'],[],[],"[{'cui': 'C1273567', 'cui_str': 'Psychotherapy (specialty)'}]",[],,0.115922,,"[{'ForeName': 'Jan Philipp', 'Initials': 'JP', 'LastName': 'Klein', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Lübeck University, Lübeck, Germany, philipp.klein@uksh.de.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Probst', 'Affiliation': 'Department for Psychotherapy and Biopsychosocial Health, Danube University Krems, Krems, Austria.'}, {'ForeName': 'Levente', 'Initials': 'L', 'LastName': 'Kriston', 'Affiliation': 'Department of Medical Psychology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Nele', 'Initials': 'N', 'LastName': 'Assmann', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Lübeck University, Lübeck, Germany.'}, {'ForeName': 'Josef', 'Initials': 'J', 'LastName': 'Bailer', 'Affiliation': 'Department of Clinical Psychology, Central Institute of Mental Health, Medical Faculty Mannheim/University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Eich', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Lübeck University, Lübeck, Germany.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Schweiger', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Lübeck University, Lübeck, Germany.'}, {'ForeName': 'Nikola Maria', 'Initials': 'NM', 'LastName': 'Stenzel', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Psychologische Hochschule Berlin, Berlin, Germany.'}, {'ForeName': 'Katrin', 'Initials': 'K', 'LastName': 'Wambach', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, University of Marburg, Marburg, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Hautzinger', 'Affiliation': 'Department of Psychology, Clinical Psychology and Psychotherapy, Eberhard Karls University Tübingen, Tübingen, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Härter', 'Affiliation': 'Department of Medical Psychology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Schramm', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Freiburg, Freiburg, Germany.'}]",Psychotherapy and psychosomatics,['10.1159/000506082'] 1452,18504093,Reliability and validity of the Functional Assessment of Chronic Illness Therapy-Palliative care (FACIT-Pal) scale.,"The Functional Assessment of Chronic Illness Therapy (FACIT) system provides a general, multidimensional measure of health-related quality of life (FACT-G) that can be augmented with disease or symptom-specific subscales. The 19-item palliative care subscale of the FACIT system has undergone little psychometric evaluation to date. The aim of this paper is to report the internal consistency, factor structure, and construct validity of the instrument using the palliative care subscale (FACIT-Pal). Two hundred fifty-six persons with advanced cancer in a randomized trial testing a palliative care psychoeducational intervention completed the 46-item FACIT-Pal at baseline. Internal consistency was greater than 0.74 for all subscales and the total score. Seventeen of the 19 palliative care subscale items loaded onto the four-factor solution of the established core measure (FACT-G). As hypothesized, total scores were correlated with measures of symptom intensity (r=-0.73, P<0.001) and depression (r=-0.75, P<0.001). The FACIT-Pal was able to discriminate between participants who died within three months of completing the baseline and participants who lived for at least one year after completing the baseline assessment (t=-4.05, P<0.001). The functional well-being subscale discriminated between participants who had a Karnofsky performance score of 70 and below and participants with a Karnofsky performance score of 80 and above (t=3.40, P<0.001). The findings support the internal consistency reliability and validity of the FACIT-Pal as a measure of health-related quality of life for persons with advanced cancer.",2009,"The functional well-being subscale discriminated between participants who had a Karnofsky performance score of 70 and below and participants with a Karnofsky performance score of 80 and above (t=3.40, P<0.001).","['Two hundred fifty-six persons with advanced cancer', 'Seventeen of the 19 palliative care subscale items loaded onto the four-factor solution of the established core measure (FACT-G', 'persons with advanced cancer']","['Chronic Illness Therapy-Palliative care (FACIT-Pal) scale', 'palliative care psychoeducational intervention']","['symptom intensity', 'Internal consistency']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}, {'cui': 'C0450331', 'cui_str': '17 (qualifier value)'}, {'cui': 'C0700049', 'cui_str': 'Palliative care'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}, {'cui': 'C0443211', 'cui_str': 'Established (qualifier value)'}, {'cui': 'C0444669', 'cui_str': 'Core (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}]","[{'cui': 'C0008679', 'cui_str': 'Chronic Illness'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0700049', 'cui_str': 'Palliative care'}, {'cui': 'C0222045'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0205102', 'cui_str': 'Internal (qualifier value)'}, {'cui': 'C0332529', 'cui_str': 'Consistency finding'}]",256.0,0.0531053,"The functional well-being subscale discriminated between participants who had a Karnofsky performance score of 70 and below and participants with a Karnofsky performance score of 80 and above (t=3.40, P<0.001).","[{'ForeName': 'Kathleen Doyle', 'Initials': 'KD', 'LastName': 'Lyons', 'Affiliation': 'Department of Psychiatry, Dartmouth Medical School, Hanover, NH, USA. kathleen.d.lyons@dartmouth.edu'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Bakitas', 'Affiliation': ''}, {'ForeName': 'Mark T', 'Initials': 'MT', 'LastName': 'Hegel', 'Affiliation': ''}, {'ForeName': 'Brett', 'Initials': 'B', 'LastName': 'Hanscom', 'Affiliation': ''}, {'ForeName': 'Jay', 'Initials': 'J', 'LastName': 'Hull', 'Affiliation': ''}, {'ForeName': 'Tim A', 'Initials': 'TA', 'LastName': 'Ahles', 'Affiliation': ''}]",Journal of pain and symptom management,['10.1016/j.jpainsymman.2007.12.015'] 1453,32045087,Experience-based co-design-Adapting the method for a researcher-initiated study in a multi-site setting.,"BACKGROUND Experience-based co-design (EBCD) brings patients and staff together to co-design services. It is normally conducted in one organization which initiates and implements the process. We used the traditional EBCD method with a number of adaptations as part of a larger research study in the British National Health Service. METHODS The primary aim was to assess the feasibility and acceptability of conducting research-initiated EBCD, to enhance intervention development prior to testing. As well as embedding the method in a research study, there were 3 further key adaptations: (a) working across primary and secondary care sectors, (b) working on multiple sites and (c) incorporating theory-informed analysis. RESULTS We recruited four sites (covering both primary and secondary care) and, on each site, conducted the initial traditional EBCD meetings, with separate staff and patient groups-followed by a single joint patient-staff event, where four priority areas for co-design were agreed. This event was driven by theory-informed analysis, as well as the traditional trigger film of patient experiences. Each site worked on one priority area, and the four co-design groups met over 2-3 months to design prototype tools. A second joint event was held (not usually undertaken in single-site EBCD) where they shared and compared outputs. The research team combined elements of these outputs to create an intervention, now being tested in a cluster randomized controlled trial. CONCLUSIONS EBCD can be successfully adapted for use across an entire patient pathway with multiple organizations and as part of a research process to identify an intervention for subsequent testing in a randomized trial. Our pragmatic approach used the patient experience to identify areas for improvement and co-designed an intervention which directly reflected patient priorities.",2020,Our pragmatic approach used the patient experience to identify areas for improvement and co-designed an intervention which directly reflected patient priorities.,[],[],['feasibility and acceptability'],[],[],"[{'cui': 'C3645535', 'cui_str': 'Acceptability'}]",,0.026757,Our pragmatic approach used the patient experience to identify areas for improvement and co-designed an intervention which directly reflected patient priorities.,"[{'ForeName': 'David K', 'Initials': 'DK', 'LastName': 'Raynor', 'Affiliation': 'University of Leeds, Leeds, UK.'}, {'ForeName': 'Hanif', 'Initials': 'H', 'LastName': 'Ismail', 'Affiliation': 'University of Bradford, Bradford, UK.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Blenkinsopp', 'Affiliation': 'University of Bradford, Bradford, UK.'}, {'ForeName': 'Beth', 'Initials': 'B', 'LastName': 'Fylan', 'Affiliation': 'University of Bradford, Bradford, UK.'}, {'ForeName': 'Gerry', 'Initials': 'G', 'LastName': 'Armitage', 'Affiliation': 'University of Bradford, Bradford, UK.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Silcock', 'Affiliation': 'University of Bradford, Bradford, UK.'}]",Health expectations : an international journal of public participation in health care and health policy,['10.1111/hex.13028'] 1454,30388938,Is it necessary to approach the compressed vertebra bilaterally during the process of PKP?,"OBJECTIVE To assess the clinical and radiological outcomes following unilateral or bilateral approach in percutaneous kyphoplasty (PKP) for treatment of osteoporotic vertebral compression fractures (OVCF). DESIGN Prospective comparative study. SETTING University affiliated hospital. PARICIPANTS From 2012 through 2016, those MRI-diagnosed single-level lumbar OVCF patients. INTERVENTIONS They were randomly assigned for treatment with unilateral or bilateral PKP. OUTCOME MEASURES We assessed the patient' health status with the Oswestry Disability Index (ODI) questionnaire. Anteroposterior and lateral standing radiographs were obtained to measure the vertebral height and kyphotic angle of the vertebral body in all patients. RESULTS Eighty-five patients were finally enrolled in this investigation, including 42 in the unilateral and 43 in the bilateral group. The operation time, PMMA volume, radiation dose was 25.6 ± 4.2 minutes, 6.2 ± 3.5 ml and 0.88 ± 0.28 mSv in the unilateral group, while 36.6 ± 8.7 minutes, 8.5 ± 2.2 ml and 1.89 ± 1.05 mSv in the bilateral group, respectively (P < 0.05). The postoperative VAS and ODI were 2.7 ± 1.2 and 19.8 ± 6.4 compared to preoperative 8.7 ± 1.6 and 35.2 ± 4.3 in unilateral group, while 2.6 ± 1.3 and 19.7 ± 2.6 compared to preoperative 8.5 ± 1.3 and 36.7 ± 3.6 in bilateral group, respectively (P > 0.05). CONCLUSION Both bilateral and unilateral PKP are relatively safe and provide effective treatment for patients with painful OVCF. However, unilateral PKP need less radiation dose, operation time and PMMA volume.",2020,"The postoperative VAS and ODI were 2.7 ± 1.2 and 19.8 ± 6.4 compared to preoperative 8.7 ± 1.6 and 35.2 ± 4.3 in unilateral group, while 2.6 ± 1.3 and 19.7 ± 2.6 compared to preoperative 8.5 ± 1.3 and 36.7 ± 3.6 in bilateral group, respectively (P > 0.05).","['Setting University affiliated hospital', 'Paricipants From 2012 through 2016, those MRI-diagnosed single-level lumbar OVCF patients', 'Results Eighty-five patients were finally enrolled in this investigation, including 42 in the unilateral and 43 in the bilateral group', 'patients with painful OVCF', 'osteoporotic vertebral compression fractures (OVCF']","['unilateral or bilateral PKP', 'unilateral or bilateral approach in percutaneous kyphoplasty (PKP']","[""patient' health status with the Oswestry Disability Index (ODI) questionnaire"", 'vertebral height and kyphotic angle of the vertebral body', 'operation time, PMMA volume, radiation dose', 'unilateral PKP need less radiation dose, operation time and PMMA volume', 'postoperative VAS and ODI']","[{'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0024090', 'cui_str': 'Lumbar Region'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C4517892', 'cui_str': '85'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0521169', 'cui_str': 'Compression fracture (morphologic abnormality)'}]","[{'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach - access (qualifier value)'}, {'cui': 'C1455863', 'cui_str': 'Balloon Vertebroplasty'}]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0018759', 'cui_str': 'Level of Health'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index (assessment scale)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205143', 'cui_str': 'Angular (qualifier value)'}, {'cui': 'C0223084', 'cui_str': 'Structure of body of vertebra'}, {'cui': 'C0038895', 'cui_str': 'operative therapy'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0005533', 'cui_str': 'PMMA'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}]",85.0,0.0216385,"The postoperative VAS and ODI were 2.7 ± 1.2 and 19.8 ± 6.4 compared to preoperative 8.7 ± 1.6 and 35.2 ± 4.3 in unilateral group, while 2.6 ± 1.3 and 19.7 ± 2.6 compared to preoperative 8.5 ± 1.3 and 36.7 ± 3.6 in bilateral group, respectively (P > 0.05).","[{'ForeName': 'Ming Xing', 'Initials': 'MX', 'LastName': 'Liu', 'Affiliation': 'Department of Neurosurgery, XinHua Hospital Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Xia', 'Affiliation': 'Department of Neurosurgery, XinHua Hospital Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Zhong', 'Affiliation': 'Department of Neurosurgery, XinHua Hospital Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Ning Ning', 'Initials': 'NN', 'LastName': 'Dou', 'Affiliation': 'Department of Neurosurgery, XinHua Hospital Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Li', 'Affiliation': 'Department of Neurosurgery, XinHua Hospital Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}]",The journal of spinal cord medicine,['10.1080/10790268.2018.1451238'] 1455,31571560,What makes one respond to acupuncture for insomnia? Perspectives of cancer survivors.,"OBJECTIVE Like any therapy, acupuncture is effective for some patients, while not helpful for others. Understanding from a patients' perspective what makes one respond or not to acupuncture can help guide further intervention development. This study aimed to identify factors that influence the perception of acupuncture's therapeutic effect among cancer survivors with insomnia. METHOD We conducted post-treatment semi-structured interviews with cancer survivors who were randomized to the acupuncture group in a clinical trial for the treatment of insomnia. Survivors were categorized into Responders and Non-Responders to acupuncture treatment based on the change in the Insomnia Severity Index with a reduction of eight points or greater as the cut-off for the response. An integrated approach to data analysis was utilized by merging an a priori set of codes derived from the key ideas and a set of codes that emerged from the data through a grounded theory approach. Codes were examined for themes and patterns. RESULTS Among 28 cancer survivors interviewed, 18 (64%) were classified as Responders. Participants perceived the ability to respond to acupuncture as dependent on treatment that effectively: (1) alleviated co-morbidities contributing to insomnia, (2) supported sleep hygiene practices, and (3) provided a durable therapeutic effect. Acupuncture treatment that did not address one of these themes often detracted from positive treatment outcomes and diminished perceived benefit from acupuncture. SIGNIFICANCE OF RESULTS We identified patient-perceived contributors to response to acupuncture, such as co-morbid medical conditions, adequate support for sleep hygiene practices, and temporary therapeutic relief. Addressing these factors may improve the overall effectiveness of acupuncture for insomnia.",2020,"Acupuncture treatment that did not address one of these themes often detracted from positive treatment outcomes and diminished perceived benefit from acupuncture. ","['28 cancer survivors', 'cancer survivors with insomnia', 'cancer survivors']","['acupuncture', 'Acupuncture']",['Insomnia Severity Index'],"[{'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}]","[{'cui': 'C4520529', 'cui_str': 'Insomnia severity index (assessment scale)'}]",,0.0602409,"Acupuncture treatment that did not address one of these themes often detracted from positive treatment outcomes and diminished perceived benefit from acupuncture. ","[{'ForeName': 'Sally A D', 'Initials': 'SAD', 'LastName': 'Romero', 'Affiliation': 'Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Eileen', 'Initials': 'E', 'LastName': 'Jiang', 'Affiliation': 'School of Medicine, New York University, New York, NY.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Bussell', 'Affiliation': 'A Center for Oriental Medicine, Chicago, IL.'}, {'ForeName': 'Whitney', 'Initials': 'W', 'LastName': 'Eriksen', 'Affiliation': 'Department of Family Medicine and Community Health, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Katherine N', 'Initials': 'KN', 'LastName': 'Duhamel', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Frances K', 'Initials': 'FK', 'LastName': 'Barg', 'Affiliation': 'Department of Family Medicine and Community Health, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Jun J', 'Initials': 'JJ', 'LastName': 'Mao', 'Affiliation': 'Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY.'}]",Palliative & supportive care,['10.1017/S1478951519000762'] 1456,32428369,Susceptibility-guided therapy for Helicobacter pylori-infected penicillin-allergic patients: A prospective clinical trial of first-line and rescue therapies.,"BACKGROUND Helicobacter pylori (H pylori) treatment remains a challenge for penicillin-allergic patients. AIM To evaluate the efficacy and tolerability of susceptibility-guided first-line and rescue treatment in H pylori-infected penicillin-allergic patients. METHODS Consecutive H pylori-infected patients with penicillin allergy received a 14-day triple or quadruple therapy based on susceptibility to clarithromycin, levofloxacin, and metronidazole. All received esomeprazole 20 mg twice a day. Metronidazole-susceptible infections received metronidazole plus clarithromycin or levofloxacin triple therapy if susceptible. Clarithromycin- and levofloxacin-resistant infections received metronidazole plus tetracycline triple therapy. Metronidazole-resistant infections received a bismuth-high-dose metronidazole plus clarithromycin or levofloxacin quadruple therapy. Triple-resistant infections received classical bismuth quadruple therapy with high-dose metronidazole. Antimicrobial susceptibility was assessed using the E test method. RESULTS 112 patients were entered (34.8% men, average 47.1 years). Infections in 83.8% (31/37) of treatment-naive subjects and 12.0% (9/75) (P < .001) receiving rescue treatment were susceptible to at least one of the three tested antibiotics. Overall, susceptibility-guided therapy achieved eradication rates of 92.9% (104/112, 95% CI 88.1%-97.7%) by intent-to-treat analysis and 99% (100/101, 95% CI 97.1%-100%) by per-protocol analysis. All regimens achieved eradication rates greater than 90% (P = .327) in the PP populations. Adverse events were relatively frequent; however, compliance remained high. CONCLUSION Susceptibility-guided therapy proved highly effective for penicillin-allergic patients. When available and proven locally effective, the alternative was empiric classical bismuth quadruple therapy. This trial is registered with ClinicalTrials.gov as NCT03708848.",2020,"Overall, susceptibility-guided therapy achieved eradication rates of 92.9% (104/112, 95% CI 88.1%-97.7%) by intent-to-treat analysis and 99% (100/101, 95% CI 97.1%-100%) by per-protocol analysis.","['H pylori-infected penicillin-allergic patients', 'penicillin-allergic patients', '112 patients were entered (34.8% men, average 47.1\xa0years', 'Consecutive H pylori-infected patients with penicillin allergy received a', 'Helicobacter pylori-infected penicillin-allergic patients']","['bismuth-high-dose metronidazole plus clarithromycin or levofloxacin quadruple therapy', 'Susceptibility-guided therapy', 'metronidazole plus tetracycline triple therapy', 'esomeprazole', 'metronidazole plus clarithromycin', '14-day triple or quadruple therapy', 'levofloxacin triple therapy', 'Metronidazole', 'Clarithromycin- and levofloxacin', 'classical bismuth quadruple therapy with high-dose metronidazole', 'clarithromycin, levofloxacin, and metronidazole', 'susceptibility-guided first-line']","['Adverse events', 'Antimicrobial susceptibility', 'efficacy and tolerability', 'eradication rates', 'Infections']","[{'cui': 'C0079488', 'cui_str': 'Helicobacter pylori'}, {'cui': 'C0030842', 'cui_str': 'Penicillin'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C1522196', 'cui_str': 'Enteral route'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0030824', 'cui_str': 'Allergy to penicillin'}]","[{'cui': 'C0005642', 'cui_str': 'Bismuth'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0025872', 'cui_str': 'Metronidazole'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0055856', 'cui_str': 'Clarithromycin'}, {'cui': 'C0282386', 'cui_str': 'Levofloxacin'}, {'cui': 'C0205175', 'cui_str': 'Quadruple'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0012655', 'cui_str': 'Diathesis'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0039644', 'cui_str': 'Tetracycline'}, {'cui': 'C0205174', 'cui_str': 'Triple'}, {'cui': 'C0937846', 'cui_str': 'Esomeprazole'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0205132', 'cui_str': 'Linear'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0427965', 'cui_str': 'Antimicrobial susceptibility - finding'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}]",112.0,0.034533,"Overall, susceptibility-guided therapy achieved eradication rates of 92.9% (104/112, 95% CI 88.1%-97.7%) by intent-to-treat analysis and 99% (100/101, 95% CI 97.1%-100%) by per-protocol analysis.","[{'ForeName': 'Laisheng', 'Initials': 'L', 'LastName': 'Luo', 'Affiliation': 'Division of Gastroenterology and Hepatology, Key Laboratory of Gastroenterology and Hepatology, Ministry of Health, Shanghai Institute of Digestive Disease, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': 'Division of Gastroenterology and Hepatology, Key Laboratory of Gastroenterology and Hepatology, Ministry of Health, Shanghai Institute of Digestive Disease, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'Liang', 'Affiliation': 'Division of Gastroenterology and Hepatology, Key Laboratory of Gastroenterology and Hepatology, Ministry of Health, Shanghai Institute of Digestive Disease, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Yingjie', 'Initials': 'Y', 'LastName': 'Ji', 'Affiliation': 'Division of Gastroenterology and Hepatology, Key Laboratory of Gastroenterology and Hepatology, Ministry of Health, Shanghai Institute of Digestive Disease, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Lou', 'Initials': 'L', 'LastName': 'Yu', 'Affiliation': 'Division of Gastroenterology and Hepatology, Key Laboratory of Gastroenterology and Hepatology, Ministry of Health, Shanghai Institute of Digestive Disease, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Lu', 'Affiliation': 'Division of Gastroenterology and Hepatology, Key Laboratory of Gastroenterology and Hepatology, Ministry of Health, Shanghai Institute of Digestive Disease, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.'}]",Helicobacter,['10.1111/hel.12699'] 1457,30840918,"Daily oligofructose-enriched inulin intake impacts bone turnover markers but not the cytokine profile in pediatric patients with celiac disease on a gluten-free diet: Results of a randomised, placebo-controlled pilot study.","BACKGROUND Bone metabolism disturbances are commonly observed in patients with newly diagnosed celiac disease (CD). The only available treatment for CD-the intake of a gluten-free diet (GFD)-has been found to be insufficient in effectively improving bone health in some patients. Therefore, there is an urgent need to modify the GFD so as to allow for the provision of all the necessary nutrients and improved absorption. Prebiotics intake reportedly improves the absorption of bone-related vitamin D and calcium as well as bone metabolism. The effect of prebiotic intake on bone health in CD patients has not been studied yet. This study aimed to evaluate the effect of oligofructose-enriched inulin intake on bone metabolism and immune response in children with CD on a GFD. METHODS A total of 34 children with CD were randomised into two groups receiving 10 g of oligofructose-enriched inulin (Synergy 1) or a placebo (maltodextrin) for three months, together with a strict GFD. The children's bone metabolism marker levels and cytokine profiles were analysed before and after the intervention. RESULTS After supplementation, the concentration of osteocalcin increased significantly in children receiving Synergy 1, while the concentration of bone alkaline phosphatase increased in both groups, independent of supplementation. After the intervention, the level of pyridinoline increased significantly in the placebo group, resulting in a concentration that was two times higher than that in the Synergy 1 group, in which it remained stable. Moreover, the plasma concentrations of N-terminal telopeptides of type I collagen decreased in both the groups, whereas the tartrate-resistant acid phosphatase 5b level increased particularly in the Synergy 1 group. The intervention did not lead to immunological response changes. CONCLUSIONS The proposed supplementation beneficially altered bone metabolism, through increased bone formation rates and decreased bone resorption process rates. Supplementation of GFD with prebiotic oligofructose-enriched inulin may be a promising auxiliary therapy for bone metabolism improvements in children with CD.",2019,"I collagen decreased in both the groups, whereas the tartrate-resistant acid phosphatase 5b level increased particularly in the Synergy 1 group.","['children with CD', 'pediatric patients with celiac disease on a gluten-free diet', 'patients with newly diagnosed celiac disease (CD', 'children with CD on a GFD', 'CD patients', '34 children with CD']","['prebiotic intake', 'oligofructose-enriched inulin intake', 'placebo', '10\u202fg of oligofructose-enriched inulin (Synergy 1) or a placebo (maltodextrin', 'Daily oligofructose-enriched inulin intake']","['level of pyridinoline', 'bone metabolism and immune response', 'absorption of bone-related vitamin D and calcium', 'plasma concentrations of N-terminal telopeptides of type', 'concentration of bone alkaline phosphatase', 'concentration of osteocalcin', 'bone health', ""children's bone metabolism marker levels and cytokine profiles"", 'tartrate-resistant acid phosphatase 5b level', 'bone formation rates']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0007570', 'cui_str': 'Sprue, Nontropical'}, {'cui': 'C0344351', 'cui_str': 'Gluten-Free Diet'}]","[{'cui': 'C2717875', 'cui_str': 'Prebiotics'}, {'cui': 'C0907858', 'cui_str': 'oligofructose'}, {'cui': 'C0021936', 'cui_str': 'Inulin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1318182', 'cui_str': '10G'}, {'cui': 'C0065601', 'cui_str': 'maltodextrin'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0072690', 'cui_str': 'hydroxylysyl pyridinoline'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0025520', 'cui_str': 'metabolism'}, {'cui': 'C0301872', 'cui_str': 'Immune response, function (observable entity)'}, {'cui': 'C2347023', 'cui_str': 'Absorption'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C1868883', 'cui_str': 'Bone alkaline phosphatase'}, {'cui': 'C0373691', 'cui_str': 'Osteocalcin measurement (procedure)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}, {'cui': 'C2106410', 'cui_str': 'Tartrate-resistant acid phosphatase'}, {'cui': 'C0029433', 'cui_str': 'Ossification'}]",34.0,0.148283,"I collagen decreased in both the groups, whereas the tartrate-resistant acid phosphatase 5b level increased particularly in the Synergy 1 group.","[{'ForeName': 'Natalia', 'Initials': 'N', 'LastName': 'Drabińska', 'Affiliation': 'Department of Chemistry and Biodynamics of Food, Institute of Animal Reproduction and Food Research of Polish Academy of Sciences, Tuwima 10 Str., 10-748 Olsztyn, Poland. Electronic address: n.drabinska@pan.olsztyn.pl.'}, {'ForeName': 'Elżbieta', 'Initials': 'E', 'LastName': 'Jarocka-Cyrta', 'Affiliation': 'Department of Pediatrics, Gastroenterology and Nutrition Collegium Medicum School of Medicine University of Warmia and Masuria, Żołnierska 18A Str., 10-561 Olsztyn, Poland. Electronic address: ejarocka@o2.pl.'}, {'ForeName': 'Dagmara', 'Initials': 'D', 'LastName': 'Złotkowska', 'Affiliation': 'Department of Immunology and Food Microbiology, Institute of Animal Reproduction and Food Research of Polish Academy of Sciences, Tuwima 10 Str., 10-748 Olsztyn, Poland. Electronic address: d.zlotkowska@pan.olsztyn.pl.'}, {'ForeName': 'Paweł', 'Initials': 'P', 'LastName': 'Abramowicz', 'Affiliation': 'Department of Pediatrics, Rheumatology, Immunology and Metabolic Bone Diseases, Medical University of Bialystok, Bialystok, Poland. Electronic address: pabram@o2.pl.'}, {'ForeName': 'Urszula', 'Initials': 'U', 'LastName': 'Krupa-Kozak', 'Affiliation': 'Department of Chemistry and Biodynamics of Food, Institute of Animal Reproduction and Food Research of Polish Academy of Sciences, Tuwima 10 Str., 10-748 Olsztyn, Poland. Electronic address: u.krupa-kozak@pan.olsztyn.pl.'}]",Bone,['10.1016/j.bone.2019.03.001'] 1458,18632241,"A randomized, placebo-controlled trial of doxycycline after endoluminal aneurysm repair.","BACKGROUND The late durability of endovascular aneurysm repair (EVAR) has been limited by progressive aortic degeneration believed to be mediated by matrix metalloproteases (MMP). The goal of this study was to evaluate the effect of a MMP inhibitor, doxycycline, on EVAR. METHODS Patients undergoing EVAR were randomized to doxycycline (100 mg twice daily) or placebo for 6 months following the procedure. Clinical data, blood samples, and computed tomography (CT) scans were obtained preoperatively, postoperatively (blood only), and at 1- and 6-month follow-up. Forty-four subjects were analyzed based on intention-to-treat. RESULTS Plasma MMP-9 decreased significantly below baseline in the doxycycline (N = 20) treated patients at 6 months (-16.4% +/- 20.7%, P < .05) while there was a nonsignificant increase in the placebo (N = 24) group (128.1% +/- 73.5%). This was primarily related to changes between 1 and 6 months. In patients with endoleaks at 6 months, plasma MMP-9 increased in 83% of the placebo treated patients, but in only 14% of the doxycycline treated group (P < .03). Among endoleak-free patients with AneuRx or Excluder endografts, doxycycline treatment resulted in greater decreases in maximum aortic diameter than placebo treatment (-13.3% +/- 3.3% vs -3.8% +/- 3.0%, P < .05). Furthermore, doxycycline treatment significantly reduced the aortic neck dilatation at 6 months in Excluder treated patients. CONCLUSION There is evidence of persistent MMP release representing ongoing aortic degradation after endografting which can be inhibited by doxycycline therapy. In analyses based on the endograft used, treatment with doxycycline also demonstrated evidence of increased aortic dimensional stability, a surrogate marker for long-term success of EVAR. Although encouraging, these results require confirmation in larger patient populations. Doxycycline should undergo more thorough evaluation as a potential adjuvant treatment to improve the results of EVAR, particularly in certain subgroups.",2008,"In patients with endoleaks at 6 months, plasma MMP-9 increased in 83% of the placebo treated patients, but in only 14% of the doxycycline treated group (P < .03).","['Patients undergoing EVAR', 'Forty-four subjects were analyzed based on intention-to-treat']","['doxycycline', 'MMP inhibitor, doxycycline', 'placebo', 'Doxycycline', 'endovascular aneurysm repair (EVAR']","['Clinical data, blood samples, and computed tomography (CT) scans', 'Plasma MMP-9', 'aortic dimensional stability', 'plasma MMP-9', 'maximum aortic diameter', 'aortic neck dilatation']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4319568', 'cui_str': '44'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}]","[{'cui': 'C0013090', 'cui_str': 'Doxycycline'}, {'cui': 'C1513016', 'cui_str': 'MMP Inhibitors'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0189661', 'cui_str': 'Repair of aneurysm'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}, {'cui': 'C0441633'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0623362', 'cui_str': 'MMPs'}, {'cui': 'C0003483', 'cui_str': 'Aorta'}, {'cui': 'C0579133', 'cui_str': 'Aortic diameter (observable entity)'}, {'cui': 'C0027536', 'cui_str': 'Necking (finding)'}, {'cui': 'C1322279', 'cui_str': 'Dilation'}]",44.0,0.286483,"In patients with endoleaks at 6 months, plasma MMP-9 increased in 83% of the placebo treated patients, but in only 14% of the doxycycline treated group (P < .03).","[{'ForeName': 'Amy E', 'Initials': 'AE', 'LastName': 'Hackmann', 'Affiliation': 'Department of Surgery (Section of Vascular Surgery), Washington University School of Medicine, St. Louis, Mo.'}, {'ForeName': 'Brian G', 'Initials': 'BG', 'LastName': 'Rubin', 'Affiliation': ''}, {'ForeName': 'Luis A', 'Initials': 'LA', 'LastName': 'Sanchez', 'Affiliation': ''}, {'ForeName': 'Patrick A', 'Initials': 'PA', 'LastName': 'Geraghty', 'Affiliation': ''}, {'ForeName': 'Robert W', 'Initials': 'RW', 'LastName': 'Thompson', 'Affiliation': ''}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Curci', 'Affiliation': ''}]",Journal of vascular surgery,['10.1016/j.jvs.2008.03.064'] 1459,32007324,Performance difference on the six-minute walk test on tracks of 20 and 30 meters for patients with chronic obstructive pulmonary disease: validity and reliability.,"BACKGROUND Functional capacity assessment is important in patients with chronic obstructive pulmonary disease (COPD). It can be performed by the six-minute walk test (6MWT) on a 30-meter track. However, such space is not always available in clinical settings. OBJECTIVES To compare the performance between the 6MWT on a 30- (6MWT 30 ) and 20-meter (6MWT 20 ) track; to evaluate the validity and reliability of the 6MWT 30 and the 6MWT 20 ; and to determine for which patients track length has the greatest impact on performance. METHODS Patients with COPD randomly performed two 6MWT 30 and two 6MWT 20 on two different days and were also assessed using the COPD Assessment Test (CAT) and modified Medical Research Council (mMRC) scale. RESULTS Thirty patients (23 men; mean ± standard deviation FEV 1 %pred: 45.6 ± 12.1) participated in the study. They walked a greater distance on the 6MWT 30 than on the 6MWT 20 [mean difference: 22.1 m (95% CI: 12, 32 m)]. The longer the 6MWT 30 distance, the greater the difference between the 2 tests (r = 0.51; p = 0.004). The 6MWT 20 showed high reliability [ICC: 0.96 (95% CI: 0.77, 0.99)] and the results were associated with the distance walked on the 6MWT 30 (r = 0.86), CAT (r = -0.53), and mMRC (r = -0.62). Patients who walked ≥430 m in the 6MWT 30 presented a difference between the tests greater than those who walked <430 m (34.5 ± 23.3 m vs. 12.6 ± 24.1 m; respectively; p = 0.01). CONCLUSIONS Performance was higher on the 6MWT 30 , with the difference increasing as performance improved. Therefore, the 6MWT 20 is valid and reliable to evaluate functional capacity but should not be considered interchangeable with the 6MWT 30 , especially for the less disabled patients with COPD.",2020,"The longer the 6MWT 30 distance, the greater the difference between the 2 tests (r = 0.51; p = 0.004).","['patients with chronic obstructive pulmonary disease', 'Thirty patients (23 men; mean\u202f±\u202fstandard deviation FEV 1 %pred: 45.6\u202f±\u202f12.1) participated in the study', 'patients with chronic obstructive pulmonary disease (COPD', 'disabled patients with COPD', 'Patients with COPD randomly performed two']","['6MWT', '6MWT 30 and two 6MWT']",['COPD Assessment Test (CAT) and modified Medical Research Council (mMRC) scale'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]",[],"[{'cui': 'C4284282', 'cui_str': 'COPD assessment test'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0079816', 'cui_str': 'Medical Research'}, {'cui': 'C0222045'}]",,0.0425474,"The longer the 6MWT 30 distance, the greater the difference between the 2 tests (r = 0.51; p = 0.004).","[{'ForeName': 'Suelen Roberta', 'Initials': 'SR', 'LastName': 'Klein', 'Affiliation': 'Center for Assistance, Teaching and Research in Pulmonary Rehabilitation (NuReab), Universidade do Estado de Santa Catarina (UDESC), Florianópolis, SC, Brazil; Human Movement Sciences Graduate Program, Centro de Ciências da Saúde e do Esporte (CEFID), Universidade do Estado de Santa Catarina (UDESC), Florianópolis, SC, Brazil.'}, {'ForeName': 'Aline Almeida', 'Initials': 'AA', 'LastName': 'Gulart', 'Affiliation': 'Center for Assistance, Teaching and Research in Pulmonary Rehabilitation (NuReab), Universidade do Estado de Santa Catarina (UDESC), Florianópolis, SC, Brazil; Human Movement Sciences Graduate Program, Centro de Ciências da Saúde e do Esporte (CEFID), Universidade do Estado de Santa Catarina (UDESC), Florianópolis, SC, Brazil.'}, {'ForeName': 'Raysa Silva', 'Initials': 'RS', 'LastName': 'Venâncio', 'Affiliation': 'Center for Assistance, Teaching and Research in Pulmonary Rehabilitation (NuReab), Universidade do Estado de Santa Catarina (UDESC), Florianópolis, SC, Brazil; Physical Therapy Graduate Program, Centro de Ciências da Saúde e do Esporte (CEFID), Universidade do Estado de Santa Catarina (UDESC), Florianópolis, SC, Brazil.'}, {'ForeName': 'Anelise Bauer', 'Initials': 'AB', 'LastName': 'Munari', 'Affiliation': 'Center for Assistance, Teaching and Research in Pulmonary Rehabilitation (NuReab), Universidade do Estado de Santa Catarina (UDESC), Florianópolis, SC, Brazil; Human Movement Sciences Graduate Program, Centro de Ciências da Saúde e do Esporte (CEFID), Universidade do Estado de Santa Catarina (UDESC), Florianópolis, SC, Brazil.'}, {'ForeName': 'Simone Graciosa', 'Initials': 'SG', 'LastName': 'Gavenda', 'Affiliation': 'Center for Assistance, Teaching and Research in Pulmonary Rehabilitation (NuReab), Universidade do Estado de Santa Catarina (UDESC), Florianópolis, SC, Brazil; Physical Therapy Graduate Program, Centro de Ciências da Saúde e do Esporte (CEFID), Universidade do Estado de Santa Catarina (UDESC), Florianópolis, SC, Brazil.'}, {'ForeName': 'Ana Carolina Benedet', 'Initials': 'ACB', 'LastName': 'Martins', 'Affiliation': 'Center for Assistance, Teaching and Research in Pulmonary Rehabilitation (NuReab), Universidade do Estado de Santa Catarina (UDESC), Florianópolis, SC, Brazil.'}, {'ForeName': 'Anamaria Fleig', 'Initials': 'AF', 'LastName': 'Mayer', 'Affiliation': 'Center for Assistance, Teaching and Research in Pulmonary Rehabilitation (NuReab), Universidade do Estado de Santa Catarina (UDESC), Florianópolis, SC, Brazil; Human Movement Sciences Graduate Program, Centro de Ciências da Saúde e do Esporte (CEFID), Universidade do Estado de Santa Catarina (UDESC), Florianópolis, SC, Brazil; Physical Therapy Graduate Program, Centro de Ciências da Saúde e do Esporte (CEFID), Universidade do Estado de Santa Catarina (UDESC), Florianópolis, SC, Brazil. Electronic address: anamaria.mayer@udesc.br.'}]",Brazilian journal of physical therapy,['10.1016/j.bjpt.2020.01.001'] 1460,32007609,"An Invited Commentary on ""Long-term results of a randomized clinical trial comparing endoscopic versus conventional treatment of pilonidal sinus"" (Int J Surg 2020; 74:81-5).",,2020,,[],['endoscopic versus conventional treatment of pilonidal sinus'],[],[],"[{'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0031925', 'cui_str': 'Pilonidal Cyst'}]",[],,0.0178456,,"[{'ForeName': 'Daniele', 'Initials': 'D', 'LastName': 'Crocetti', 'Affiliation': 'Department of Surgery ""P. Valdoni"", Sapienza University of Rome, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Cavallaro', 'Affiliation': 'Department of Surgery ""P. Valdoni"", Sapienza University of Rome, Italy. Electronic address: giuseppe.cavallaro@uniroma1.it.'}]","International journal of surgery (London, England)",['10.1016/j.ijsu.2020.01.132'] 1461,31757693,Re: Randomized double-blind clinical trial evaluation of bone healing after third molar surgery with the use of leukocyte- and platelet-rich fibrin.,,2020,,[],['leukocyte- and platelet-rich fibrin'],[],[],"[{'cui': 'C4505052', 'cui_str': 'L-PRF'}]",[],,0.63846,,"[{'ForeName': 'T', 'Initials': 'T', 'LastName': 'Pimentel', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Faculty of Odontology, Universidade do Estado do Rio de Janeiro - UERJ, Rio de Janeiro, Brazil. Electronic address: pimentelthais@outlook.com.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Ritto', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Faculty of Odontology, Universidade do Estado do Rio de Janeiro - UERJ, Rio de Janeiro, Brazil.'}, {'ForeName': 'J V', 'Initials': 'JV', 'LastName': 'Canellas', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Faculty of Odontology, Universidade do Estado do Rio de Janeiro - UERJ, Rio de Janeiro, Brazil.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Junger', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Faculty of Odontology, Universidade do Estado do Rio de Janeiro - UERJ, Rio de Janeiro, Brazil.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Cruz', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Faculty of Odontology, Universidade do Estado do Rio de Janeiro - UERJ, Rio de Janeiro, Brazil.'}, {'ForeName': 'P J', 'Initials': 'PJ', 'LastName': 'Medeiros', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Faculty of Odontology, Universidade do Estado do Rio de Janeiro - UERJ, Rio de Janeiro, Brazil.'}]",International journal of oral and maxillofacial surgery,['10.1016/j.ijom.2019.10.018'] 1462,31990061,"Correction to Walter SD, Turner RM, Macaskill P. Optimising the two-stage randomised trial design when some participants are indifferent in their treatment preferences (2019). Statistics in Medicine 38, 2317-2331.",,2020,,[],[],[],[],[],[],,0.111492,,"[{'ForeName': 'Stephen D', 'Initials': 'SD', 'LastName': 'Walter', 'Affiliation': 'Department of Health Research Methods, Evidence, and Impact, Health Sciences Center, McMaster University, Hamilton, Ontario.'}]",Statistics in medicine,['10.1002/sim.8487'] 1463,30486659,The Effect of Written Information on Recall of Surgical Risks of Primary Cleft Palate Repair: A Randomized Controlled Study.,"OBJECTIVE To investigate parents' understanding of the risks of primary cleft palate surgery after counseling with and without the use of a written informational aid. DESIGN Prospective, randomized, single-blind trial. SETTING Academic tertiary care center. PARTICIPANTS Parents of children undergoing primary cleft palate surgery. INTERVENTIONS Parents were randomized to receive a standard informed consent discussion with or without provision of a written informational aid in the form of a pamphlet. MAIN OUTCOMES MEASURE Parents' recall of 9 specific surgical risks 3 weeks after informed consent discussion. RESULTS Forty parents enrolled in and completed the study (20 participants each in the control and intervention groups). There were no statistically significant differences between groups in terms of baseline demographics. The mean number of risks recalled were 3.7 (1.6) for the control group and 4.2 (1.9) for the intervention group ( P = .37). The most commonly recalled risks were fistula formation and bleeding, while the least frequent were facial growth restriction and need for further surgery. No differences in risk recall were observed based on participant's gender, level of education, or income. CONCLUSION Parents of children undergoing primary cleft palate surgery recall less than 50% of counseled risks. The use of a written aid in the form of a pamphlet did not significantly improve recall in this sample. These results demonstrate that surgeons should implement additional measures to improve comprehension of surgical risks.",2019,There were no statistically significant differences between groups in terms of baseline demographics.,"['Forty parents enrolled in and completed the study (20 participants each in the control and intervention groups', 'Primary Cleft Palate Repair', 'Parents of children undergoing primary cleft palate surgery recall less than 50% of counseled risks', 'Academic tertiary care center', 'Parents of children undergoing primary cleft palate surgery']","['primary cleft palate surgery after counseling with and without the use of a written informational aid', 'standard informed consent discussion with or without provision of a written informational aid in the form of a pamphlet']","['fistula formation and bleeding', ""Parents' recall of 9 specific surgical risks"", 'comprehension of surgical risks', 'level of education, or income', 'risk recall', 'mean number of risks recalled']","[{'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0008925', 'cui_str': 'Cleft Palate'}, {'cui': 'C0374711', 'cui_str': 'Surgical repair (procedure)'}, {'cui': 'C0030551', 'cui_str': 'Parent of (observable entity)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0587437', 'cui_str': 'Tertiary Hospital'}]","[{'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0008925', 'cui_str': 'Cleft Palate'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0341618', 'cui_str': 'Counsel (occupation)'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0449435', 'cui_str': 'Aid (attribute)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0021430', 'cui_str': 'Informed Consent'}, {'cui': 'C0557061', 'cui_str': 'Discussion (procedure)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}]","[{'cui': 'C0016169', 'cui_str': 'Fistula'}, {'cui': 'C0439634', 'cui_str': 'Formations (qualifier value)'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}]",40.0,0.0465301,There were no statistically significant differences between groups in terms of baseline demographics.,"[{'ForeName': 'Mona T', 'Initials': 'MT', 'LastName': 'Al-Taha', 'Affiliation': '1 Division of Plastic & Reconstructive Surgery, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Michael B', 'Initials': 'MB', 'LastName': 'Butler', 'Affiliation': '2 Department of Family Medicine, University of Saskatchewan, Saskatoon, Saskatchewan, Ontario, Canada.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Hong', 'Affiliation': '3 Division of Otolaryngology, Dalhousie University, Halifax, Nova Scotia, Canada.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Bezuhly', 'Affiliation': '4 Division of Plastic & Reconstructive Surgery, Dalhousie University, Halifax, Nova Scotia, Canada.'}]",The Cleft palate-craniofacial journal : official publication of the American Cleft Palate-Craniofacial Association,['10.1177/1055665618813492'] 1464,31522954,Effectiveness of a Collaborative Nursing Care Model for the Treatment of Patients with Diabetic Foot Disease by Transverse Tibial Bone Transport Technique: A Pilot Study.,"PURPOSE Medical staff shortages remain a serious challenge, particularly to medical administrators. We aimed to analyze the effectiveness of a collaborative nursing care model in treatment of diabetic foot. DESIGN A quasi-experimental pilot study. METHODS Twenty-eight patients with diabetic foot treated by transverse tibial bone transport between January 2017 and March 2018 were randomized. The observational group received collaborative nursing care, while the control group received usual nursing care. Postoperative dorsal foot skin temperature, visual analog scale, self-rating anxiety scale (SAS) score, and other endpoints were assessed. FINDINGS Postoperative dorsal foot skin temperature was significantly higher in the observation group than in the control group. Visual analog scale and SAS scores were significantly lower in the observational group than in the control group. CONCLUSIONS The collaborative nursing care model enhanced collaboration between patient and health care providers, shortened hospital stay, and relieved postoperative pain and anxiety.",2020,"The collaborative nursing care model enhanced collaboration between patient and health care providers, shortened hospital stay, and relieved postoperative pain and anxiety.","['Patients with Diabetic Foot Disease by Transverse Tibial Bone Transport Technique', 'Twenty-eight patients with diabetic foot treated by transverse tibial bone transport between January 2017 and March 2018 were randomized']","['collaborative nursing care model', 'collaborative nursing care, while the control group received usual nursing care', 'Collaborative Nursing Care Model']","['Postoperative dorsal foot skin temperature', 'Postoperative dorsal foot skin temperature, visual analog scale, self-rating anxiety scale (SAS) score', 'postoperative pain and anxiety', 'Visual analog scale and SAS scores']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0206172', 'cui_str': 'Diabetic Foot'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0446380', 'cui_str': 'Transverse (qualifier value)'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C1317949', 'cui_str': 'Transport (physical object)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}]","[{'cui': 'C0028682', 'cui_str': 'Nursing Care'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0016504', 'cui_str': 'Foot'}, {'cui': 'C0037294', 'cui_str': 'Skin Temperature'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}]",2018.0,0.0162657,"The collaborative nursing care model enhanced collaboration between patient and health care providers, shortened hospital stay, and relieved postoperative pain and anxiety.","[{'ForeName': 'Liping', 'Initials': 'L', 'LastName': 'Jiang', 'Affiliation': 'Department of Microsurgery and Hand Surgery, Zhongnan Hospital of Wuhan University, Wuhan, P.R.China. Electronic address: Jiangliping_whu@sina.com.'}, {'ForeName': 'Regis Ernest', 'Initials': 'RE', 'LastName': 'Mendame Ehya', 'Affiliation': 'Department of Microsurgery and Hand Surgery, Zhongnan Hospital of Wuhan University, Wuhan, P.R.China.'}]",Journal of perianesthesia nursing : official journal of the American Society of PeriAnesthesia Nurses,['10.1016/j.jopan.2019.06.009'] 1465,31522953,Effects of Discharge Education and Telephone Follow-up on Cataract Patients' Activities According to the Model of Living.,"PURPOSE Assess the impact of planned discharge education and telephone follow-up of patients who underwent cataract surgery on daily living activities. DESIGN A controlled comparative study. METHODS This study was carried out on patients who underwent cataract surgery (intervention group = 72, control group = 72). Discharge education designed according to the Model of Living was used in the intervention group. Phone follow up was performed for both groups after surgery and activities were assessed. FINDINGS Significant differences were found between the two groups in applying eye drops, knowledge on using old eye glasses and protecting the operated eye, conditions requiring a physician call, conditions that may deteriorate the operated eye, personal hygiene, mobilization, and sleeping (P < .05). CONCLUSIONS Using a Model of Living in discharge education of cataract patients and following up using a structured checklist was an effective intervention. This model can be efficiently used in postoperative education of day surgery patients.",2020,"FINDINGS Significant differences were found between the two groups in applying eye drops, knowledge on using old eye glasses and protecting the operated eye, conditions requiring a physician call, conditions that may deteriorate the operated eye, personal hygiene, mobilization, and sleeping (P < .05). ","[""Cataract Patients' Activities"", 'patients who underwent cataract surgery on daily living activities', 'day surgery patients', 'patients who underwent cataract surgery (intervention group = 72, control group = 72']",['Discharge Education and Telephone Follow-up'],[],"[{'cui': 'C0856347', 'cui_str': 'Right cataract'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C2004600', 'cui_str': 'Cataract surgery specialty'}, {'cui': 'C0001288', 'cui_str': 'ADL'}, {'cui': 'C0282046', 'cui_str': 'Surgery, Day'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0178941', 'cui_str': 'Telephone follow-up'}]",[],,0.0217675,"FINDINGS Significant differences were found between the two groups in applying eye drops, knowledge on using old eye glasses and protecting the operated eye, conditions requiring a physician call, conditions that may deteriorate the operated eye, personal hygiene, mobilization, and sleeping (P < .05). ","[{'ForeName': 'Muaz', 'Initials': 'M', 'LastName': 'Gülşen', 'Affiliation': 'Department of Surgical Nursing, Çukurova University, Faculty of Health Sciences, Adana, Turkey.'}, {'ForeName': 'Neriman', 'Initials': 'N', 'LastName': 'Akansel', 'Affiliation': 'Department of Surgical Nursing, Bursa Uludağ University, Faculty of Health Sciences, Bursa, Turkey. Electronic address: nakansel@uludag.edu.tr.'}]",Journal of perianesthesia nursing : official journal of the American Society of PeriAnesthesia Nurses,['10.1016/j.jopan.2019.04.010'] 1466,32077305,Join the Commune: A Controlled Study of Social Branding Influencers to Decrease Smoking Among Young Adult Hipsters.,"PURPOSE To evaluate the impact of a Social Branding intervention in bars and nightclubs on smoking behavior. DESIGN Quasi-experimental controlled study. SETTING Bars and nightclubs in San Diego and San Francisco (intervention) and Los Angeles (control). PARTICIPANTS ""Hipster"" young adults (age 18-26) attending bars and nightclubs. INTERVENTION Anti-tobacco messages delivered through monthly anti-tobacco music/social events, opinion leaders, original art, direct mail, promotional activities, and online media. MEASURES A total of 7240 surveys were collected in 3 cities using randomized time location sampling at baseline (2012-2013) and follow-up (2015-2016); data were analyzed in 2018. The primary outcome was current smoking. ANALYSIS Multivariable logistic regression assessed correlates of smoking, adjusting for covariates including electronic cigarette use; differences between cities were evaluated using location-by-time interactions. RESULTS Smoking in San Francisco decreased at a significantly faster rate (51.1%-44.1%) than Los Angeles (45.2%-44.5%) ( P = .034). Smoking in San Diego (mean: 39.6%) was significantly lower than Los Angeles (44.8%, P < .001) at both time points with no difference in rate of change. Brand recall was not associated with smoking behavior, but recall was associated with anti-tobacco attitudes that were associated with smoking. CONCLUSION This is the first controlled study of Social Branding interventions. Intervention implementation was accompanied by decreases in smoking (San Francisco) and sustained lower smoking (San Diego) among young adult bar patrons over 3 years.",2020,Intervention implementation was accompanied by decreases in smoking (San Francisco) and sustained lower smoking (San Diego) among young adult bar patrons over 3 years.,"['Young Adult Hipsters', 'Hipster"" young adults (age 18-26) attending bars and nightclubs', 'A total of 7240 surveys were collected in 3 cities using randomized time location sampling at baseline (2012-2013) and follow-up (2015-2016); data were analyzed in 2018', 'Join the Commune', 'Bars and nightclubs in San Diego and San Francisco (intervention) and Los Angeles (control']","['Social Branding intervention', 'Anti-tobacco messages delivered through monthly anti-tobacco music/social events, opinion leaders, original art, direct mail, promotional activities, and online media']","['smoking (San Francisco) and sustained lower smoking (San Diego', 'faster rate', 'current smoking', 'Smoking in San Francisco']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0993613', 'cui_str': 'Bar (basic dose form)'}, {'cui': 'C0442567', 'cui_str': 'Nightclub (environment)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0450429', 'cui_str': 'Location (attribute)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0036152', 'cui_str': 'San Francisco'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0040329', 'cui_str': 'Tobacco Products'}, {'cui': 'C0332177', 'cui_str': 'Monthly (qualifier value)'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0871010', 'cui_str': 'Opinions'}, {'cui': 'C0205313', 'cui_str': 'Original (qualifier value)'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C0024492', 'cui_str': 'Mail'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0439536', 'cui_str': 'Medium (qualifier value)'}]","[{'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0036152', 'cui_str': 'San Francisco'}, {'cui': 'C0443318', 'cui_str': 'Sustained (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}]",7240.0,0.0214507,Intervention implementation was accompanied by decreases in smoking (San Francisco) and sustained lower smoking (San Diego) among young adult bar patrons over 3 years.,"[{'ForeName': 'Pamela M', 'Initials': 'PM', 'LastName': 'Ling', 'Affiliation': 'Division of General Internal Medicine and Center for Tobacco Control Research and Education, Department of Medicine, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Nadra E', 'Initials': 'NE', 'LastName': 'Lisha', 'Affiliation': 'Division of General Internal Medicine and Center for Tobacco Control Research and Education, Department of Medicine, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Torsten B', 'Initials': 'TB', 'LastName': 'Neilands', 'Affiliation': 'Center for AIDS Prevention Studies, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Jeffrey W', 'Initials': 'JW', 'LastName': 'Jordan', 'Affiliation': 'Rescue Agency, San Diego, CA, USA.'}]",American journal of health promotion : AJHP,['10.1177/0890117120904917'] 1467,17196967,Effect of bezafibrate therapy on atherosclerotic aortic plaques detected by MRI in dyslipidemic patients with hypertriglyceridemia.,"Fibrates reduce triglycerides (TG) and increase HDL-cholesterol levels, but there was no report showing plaque regression by fibrates. Using MRI, we investigated the effects of bezafibrate on aortic plaques in 22 dyslipidemic patients. All patients were asked to receive 400mg bezafibrate, but 8 who declined to have bezafibrate became the control group. Changes in vessel wall area (VWA) and lumen area (LA) from baseline to 1-year were evaluated. Bezafibrate reduced TG (-55%) and increased HDL-cholesterol levels (+29%). Bezafibrate reduced HDL size and increased LDL size. In thoracic plaques, bezafibrate reduced VWA (-6%, P<0.001) with no LA change, but VWA slightly progressed without bezafibrate (+5%). In abdominal plaques, bezafibrate reduced VWA (-8%, P<0.001) with LA increase (+3%, P<0.02), but VWA progressed without bezafibrate (+6%). VWA changes in thoracic and abdominal plaques correlated with TG reduction and HDL-cholesterol increase. Notably, VWA change in only abdominal plaques correlated with HDL size reduction and LDL size increase. Thus, bezafibrate induced plaque regression in thoracic and abdominal aortas with marked TG reduction and HDL-cholesterol increase, but the processes of plaque regression and vascular remodeling may differ between thoracic and abdominal aortas. However, because our study was not a controlled, randomized trial, further study is needed.",2008,"In thoracic plaques, bezafibrate reduced VWA (-6%, P<0.001) with no LA change, but VWA slightly progressed without bezafibrate (+5%).","['dyslipidemic patients with hypertriglyceridemia', '22 dyslipidemic patients']","['bezafibrate therapy', 'Bezafibrate', 'bezafibrate']","['atherosclerotic aortic plaques', 'vessel wall area (VWA) and lumen area (LA', 'Fibrates reduce triglycerides (TG) and increase HDL-cholesterol levels', 'HDL size and increased LDL size', 'HDL-cholesterol levels', 'VWA']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0020557', 'cui_str': 'Hypertriglyceridemia'}]","[{'cui': 'C0005330', 'cui_str': 'Bezafibrate'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0003483', 'cui_str': 'Aorta'}, {'cui': 'C0332461', 'cui_str': 'Plaque (morphologic abnormality)'}, {'cui': 'C0148346', 'cui_str': 'Vessel'}, {'cui': 'C0205380', 'cui_str': 'Walled (qualifier value)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0524461', 'cui_str': 'Structure of lumen of body system'}, {'cui': 'C1449704', 'cui_str': 'Fibrates'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0853084', 'cui_str': 'Increased HDL'}, {'cui': 'C0428466', 'cui_str': 'Finding of cholesterol level (finding)'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement (procedure)'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0549399', 'cui_str': 'Raised LDL'}, {'cui': 'C0018667', 'cui_str': 'Cholesterol, HDL2'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",22.0,0.0270679,"In thoracic plaques, bezafibrate reduced VWA (-6%, P<0.001) with no LA change, but VWA slightly progressed without bezafibrate (+5%).","[{'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Ayaori', 'Affiliation': 'First Department of Internal Medicine, National Defense Medical College, Saitama, Japan.'}, {'ForeName': 'Yukihiko', 'Initials': 'Y', 'LastName': 'Momiyama', 'Affiliation': 'Division of Cardiology, National Hospital Organization Tokyo Medical Center, Tokyo, Japan. Electronic address: ymomiyamajp@yahoo.co.jp.'}, {'ForeName': 'Zahi A', 'Initials': 'ZA', 'LastName': 'Fayad', 'Affiliation': 'Mount Sinai School of Medicine, New York, USA.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Yonemura', 'Affiliation': 'First Department of Internal Medicine, National Defense Medical College, Saitama, Japan.'}, {'ForeName': 'Reiko', 'Initials': 'R', 'LastName': 'Ohmori', 'Affiliation': 'First Department of Internal Medicine, National Defense Medical College, Saitama, Japan.'}, {'ForeName': 'Teruyoshi', 'Initials': 'T', 'LastName': 'Kihara', 'Affiliation': 'Iruma Heart Hospital, Saitama, Japan.'}, {'ForeName': 'Nobukiyo', 'Initials': 'N', 'LastName': 'Tanaka', 'Affiliation': 'First Department of Internal Medicine, National Defense Medical College, Saitama, Japan.'}, {'ForeName': 'Kazuhiro', 'Initials': 'K', 'LastName': 'Nakaya', 'Affiliation': 'First Department of Internal Medicine, National Defense Medical College, Saitama, Japan.'}, {'ForeName': 'Masatsune', 'Initials': 'M', 'LastName': 'Ogura', 'Affiliation': 'First Department of Internal Medicine, National Defense Medical College, Saitama, Japan.'}, {'ForeName': 'Shojiro', 'Initials': 'S', 'LastName': 'Sawada', 'Affiliation': 'First Department of Internal Medicine, National Defense Medical College, Saitama, Japan.'}, {'ForeName': 'Hiroaki', 'Initials': 'H', 'LastName': 'Taniguchi', 'Affiliation': 'First Department of Internal Medicine, National Defense Medical College, Saitama, Japan.'}, {'ForeName': 'Masatoshi', 'Initials': 'M', 'LastName': 'Kusuhara', 'Affiliation': 'First Department of Internal Medicine, National Defense Medical College, Saitama, Japan.'}, {'ForeName': 'Masayoshi', 'Initials': 'M', 'LastName': 'Nagata', 'Affiliation': 'Iruma Heart Hospital, Saitama, Japan.'}, {'ForeName': 'Haruo', 'Initials': 'H', 'LastName': 'Nakamura', 'Affiliation': 'First Department of Internal Medicine, National Defense Medical College, Saitama, Japan.'}, {'ForeName': 'Fumitaka', 'Initials': 'F', 'LastName': 'Ohsuzu', 'Affiliation': 'First Department of Internal Medicine, National Defense Medical College, Saitama, Japan.'}]",Atherosclerosis,['10.1016/j.atherosclerosis.2006.11.035'] 1468,32434619,Ageism: can a museum exhibit make a difference?,"Ageism is a key challenge to today's aging societies. ""Dialogue with Time"" is an original Israeli interactive museum exhibit that aims to change negative ageist attitudes by creating a meaningful and stereotype-breaking encounter between visitors and old age. The objective of this study was to examine whether the exhibition reduces ageist attitudes among its visitors. The study employed a comparative pre-post structure with a comparison group. A closed-answer questionnaire was supplied to 100 participants in the experimental group, visitors to the ""Dialogue with Time"" exhibit, and to 100 participants in the control group. Participants were asked to complete the questionnaire before entering the exhibits and again after experiencing them. Changes in the level of ageism were measured using the Farboni Scale of Ageism. A significant reduction in ageism attitudes was shown in the experimental group when comparing before and after the visit, t(91) = 11.75, p = 0.001, with a good effect size of Cohen's d = 0.50, whereas in the control group there was no significant change, t(76) = 0.05, p = 0.95, and a weak effect size of Cohen's d = 0.00. The findings indicate that combating ageism can also be sustained by means of museum exhibits. We recommend that museums and other similar public institutions (e.g. art galleries, exhibition halls) use public spaces to advance multigenerational exposure to positive images of aging.",2020,"A significant reduction in ageism attitudes was shown in the experimental group when comparing before and after the visit, t(91) =","['100 participants in the experimental group, visitors to the ""Dialogue with Time"" exhibit, and to 100 participants in the control group']",[],['ageism attitudes'],"[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332311', 'cui_str': 'With time'}, {'cui': 'C0015272', 'cui_str': 'Exhibits as Topic'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",[],"[{'cui': 'C0242449', 'cui_str': 'Age Discrimination'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}]",100.0,0.0251055,"A significant reduction in ageism attitudes was shown in the experimental group when comparing before and after the visit, t(91) =","[{'ForeName': 'Moran', 'Initials': 'M', 'LastName': 'Fruhauf', 'Affiliation': 'Department of Gerontology, University of Haifa, Haifa, Israel, 31905.'}, {'ForeName': 'Israel Issi', 'Initials': 'II', 'LastName': 'Doron', 'Affiliation': 'Center for Research and Study of Ageing (CRSA), University of Haifa, Haifa, Israel, 31905.'}, {'ForeName': 'Yuval', 'Initials': 'Y', 'LastName': 'Palgi', 'Affiliation': 'Department of Gerontology, University of Haifa, Haifa, Israel, 31905.'}]",International psychogeriatrics,['10.1017/S1041610220000617'] 1469,32428586,"Integrating an online weight management program with population health management in primary care: Design, methods, and baseline data from the PROPS randomized controlled trial (Partnerships for Reducing Overweight and Obesity with Patient-centered Strategies).","BACKGROUND Scalable, low-cost weight management strategies are needed in primary care. We conducted a pragmatic, cluster-randomized controlled trial to examine the effectiveness of an online weight management program integrated with population health management support. METHODS We adapted an online weight management program and integrated it with population health management support in 15 primary care practices (24 clinics). We randomized the 24 clinics to usual care (UC), online program alone (OP), or combined intervention (CI). Eligible participants had to be ages 20 to 70 and have a recent primary care visit, body mass index (BMI) ≥ 27 and < 40 kg/m 2 , and a diagnosis of hypertension or type 2 diabetes. Participants attended routine visits and completed surveys over 18 months. The primary outcome is absolute weight change at 12 months (± 90 days) after enrollment, calculated from weights measured at primary care visits and recorded in the electronic health record. RESULTS We enrolled 840 participants between July 2016 and August 2017 (326 UC, 216 OP, and 298 CI.) At enrollment, participants' mean age was 59.3 years, their mean weight was 203.1 pounds, and their mean BMI was 32.5 kg/m 2 ; 60% of participants were female, 76.8% were white, 96.4% had hypertension, and 24.4% had type 2 diabetes. CONCLUSION It is feasible to adapt an online weight management program and integrate it with population health management support in primary care. The results of this trial will provide valuable information about the effectiveness of these strategies in primary care settings. ClinicalTrials.govregistration number:NCT02656693.",2020,"We randomized the 24 clinics to usual care (UC), online program alone (OP), or combined intervention (CI).","['Eligible participants had to be ages 20 to 70 and have a recent primary care visit, body mass index (BMI)\u202f≥\u202f27 and\u202f<\u202f40\u202fkg/m 2 , and a diagnosis of hypertension or type 2 diabetes', '15 primary care practices (24 clinics', ""At enrollment, participants' mean age was 59.3\u202fyears, their mean weight was 203.1 pounds, and their mean BMI was 32.5\u202fkg/m 2 ; 60% of participants were female, 76% were white, 96.4% had hypertension, and 24.4% had type 2 diabetes"", 'We enrolled 840 participants between July 2016 and August 2017 (326 UC, 216 OP, and 298 CI']","['online weight management program with population health management', 'online weight management program and integrated it with population health management support', 'usual care (UC), online program alone (OP), or combined intervention (CI', 'online weight management program integrated with population health management support']","['absolute weight change at 12\u202fmonths (± 90\u202fdays) after enrollment, calculated from weights measured at primary care visits and recorded in the electronic health record']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0439219', 'cui_str': 'lb'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C4517710', 'cui_str': '32.5'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C4708913', 'cui_str': '840'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C5191353', 'cui_str': '326'}, {'cui': 'C4708905', 'cui_str': '216'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0205171', 'cui_str': 'Singular'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C4273558', 'cui_str': 'Weight management program'}, {'cui': 'C4704688', 'cui_str': 'Population Health Management'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0005911', 'cui_str': 'Weight change'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0444686', 'cui_str': 'Calculated'}, {'cui': 'C0043101', 'cui_str': 'Weights and Measures'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C2362543', 'cui_str': 'Computer record of patient'}]",840.0,0.0950447,"We randomized the 24 clinics to usual care (UC), online program alone (OP), or combined intervention (CI).","[{'ForeName': 'Heather J', 'Initials': 'HJ', 'LastName': 'Baer', 'Affiliation': ""Division of General Internal Medicine and Primary Care, Brigham and Women's Hospital, Boston, MA, United States of America; Harvard Medical School, Boston, MA, United States of America; Harvard T.H. Chan School of Public Health, Boston, MA, United States of America. Electronic address: hbaer@bwh.harvard.edu.""}, {'ForeName': 'Barbara A', 'Initials': 'BA', 'LastName': 'De La Cruz', 'Affiliation': ""Division of General Internal Medicine and Primary Care, Brigham and Women's Hospital, Boston, MA, United States of America.""}, {'ForeName': 'Ronen', 'Initials': 'R', 'LastName': 'Rozenblum', 'Affiliation': ""Division of General Internal Medicine and Primary Care, Brigham and Women's Hospital, Boston, MA, United States of America; Harvard Medical School, Boston, MA, United States of America.""}, {'ForeName': 'Nyryan V', 'Initials': 'NV', 'LastName': 'Nolido', 'Affiliation': ""Division of General Internal Medicine and Primary Care, Brigham and Women's Hospital, Boston, MA, United States of America.""}, {'ForeName': 'E John', 'Initials': 'EJ', 'LastName': 'Orav', 'Affiliation': ""Division of General Internal Medicine and Primary Care, Brigham and Women's Hospital, Boston, MA, United States of America; Harvard Medical School, Boston, MA, United States of America; Harvard T.H. Chan School of Public Health, Boston, MA, United States of America.""}, {'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Metzler', 'Affiliation': ""Department of Nutrition, Brigham and Women's Hospital, Boston, MA, United States of America.""}, {'ForeName': 'Jason P', 'Initials': 'JP', 'LastName': 'Block', 'Affiliation': ""Harvard Medical School, Boston, MA, United States of America; Department of Population Medicine, Harvard Pilgrim Healthcare Institute, Brigham and Women's Hospital, Boston, MA, United States of America.""}, {'ForeName': 'Florencia', 'Initials': 'F', 'LastName': 'Halperin', 'Affiliation': ""Harvard Medical School, Boston, MA, United States of America; Division of Endocrinology, Diabetes, and Hypertension, Brigham and Women's Hospital, Boston, MA, United States of America.""}, {'ForeName': 'Katherine D', 'Initials': 'KD', 'LastName': 'McManus', 'Affiliation': ""Department of Nutrition, Brigham and Women's Hospital, Boston, MA, United States of America.""}, {'ForeName': 'Louis J', 'Initials': 'LJ', 'LastName': 'Aronne', 'Affiliation': 'BMIQ Professionals Program, Intellihealth/BMIQ, United States of America; Division of Endocrinology, Diabetes, and Metabolism, Weill Cornell Medicine, New York, NY, United States of America.'}, {'ForeName': 'Guadalupe', 'Initials': 'G', 'LastName': 'Minero', 'Affiliation': 'BMIQ Professionals Program, Intellihealth/BMIQ, United States of America.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Bates', 'Affiliation': ""Division of General Internal Medicine and Primary Care, Brigham and Women's Hospital, Boston, MA, United States of America; Harvard Medical School, Boston, MA, United States of America; Harvard T.H. Chan School of Public Health, Boston, MA, United States of America.""}]",Contemporary clinical trials,['10.1016/j.cct.2020.106026'] 1470,17196208,Pentoxifylline reduces pro-inflammatory and increases anti-inflammatory activity in patients with coronary artery disease--a randomized placebo-controlled study.,"The balance between different immunological stimuli is essential in the progression and stabilization of atherosclerotic plaques. Immune regulation has been suggested as potential target for the treatment of atherosclerotic disease. We sought to determine whether treatment with pentoxifylline, a phosphodiesterase inhibitor with immunomodulating properties, could reduce the pro-inflammatory response observed in patients with acute coronary syndromes (ACS) and increase anti-inflammatory activity. In a double-blind, prospective, placebo-controlled study, 64 patients with ACS were randomized to receive pentoxifylline 400mg TID or placebo for 6 months. Analysis of the pro-inflammatory markers, C-reactive protein (CRP), interleukin (IL)-6, IL-12, interferon-gamma and tumor necrosis factor (TNF)-alpha and the anti-inflammatory cytokines, transforming growth factor (TGF)-beta1 and IL-10 were done at baseline, 1 and 6 months. Pentoxifylline treatment significantly reduced the adjusted levels of CRP and TNF-alpha compared to placebo after 6 months (P=0.04 and P<0.01, respectively). IL-12 increase was significantly less pronounced with pentoxifylline (P=0.04). The levels of the anti-inflammatory cytokine, IL-10, also declined significantly less in the pentoxifylline group compared to placebo (P<0.01) with a trend towards a higher increase of TGF-beta1 in the former group (P=0.16). Pentoxifylline reduces pro-inflammatory and increases anti-inflammatory response in patients with ACS and may have beneficial clinical effects on cardiovascular events.",2008,"Pentoxifylline treatment significantly reduced the adjusted levels of CRP and TNF-alpha compared to placebo after 6 months (P=0.04 and P<0.01, respectively).","['patients with coronary artery disease--a randomized', '64 patients with ACS', 'patients with ACS', 'patients with acute coronary syndromes (ACS']","['pentoxifylline', 'pentoxifylline 400mg TID or placebo', 'placebo', 'Pentoxifylline']","['levels of the anti-inflammatory cytokine, IL-10', 'pro-inflammatory markers, C-reactive protein (CRP), interleukin (IL)-6, IL-12, interferon-gamma and tumor necrosis factor (TNF)-alpha and the anti-inflammatory cytokines, transforming growth factor (TGF)-beta1 and IL-10', 'IL-12 increase', 'pro-inflammatory and increases anti-inflammatory response', 'pro-inflammatory and increases anti-inflammatory activity', 'adjusted levels of CRP and TNF-alpha', 'TGF-beta1']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}, {'cui': 'C0948089', 'cui_str': 'Acute Coronary Syndrome'}]","[{'cui': 'C0030899', 'cui_str': 'Pentoxifylline'}, {'cui': 'C0988533', 'cui_str': 'Pentoxifylline 400 MG'}, {'cui': 'C0908863', 'cui_str': 'TIDS'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0123759', 'cui_str': 'Interleukin-12'}, {'cui': 'C0021745', 'cui_str': 'interferon gamma'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C1704256', 'cui_str': 'Transforming Growth Factor Beta 1'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}]",64.0,0.159536,"Pentoxifylline treatment significantly reduced the adjusted levels of CRP and TNF-alpha compared to placebo after 6 months (P=0.04 and P<0.01, respectively).","[{'ForeName': 'Juliano Lara', 'Initials': 'JL', 'LastName': 'Fernandes', 'Affiliation': 'Heart Institute (InCor), University of Sao Paulo Medical School, Brazil. Electronic address: jlaraf@terra.com.br.'}, {'ForeName': 'Romulo Tadeu Dias', 'Initials': 'RTD', 'LastName': 'de Oliveira', 'Affiliation': 'State University of Campinas (UNICAMP), Brazil.'}, {'ForeName': 'Ronei Luciano', 'Initials': 'RL', 'LastName': 'Mamoni', 'Affiliation': 'State University of Campinas (UNICAMP), Brazil.'}, {'ForeName': 'Otavio Rizzi', 'Initials': 'OR', 'LastName': 'Coelho', 'Affiliation': 'State University of Campinas (UNICAMP), Brazil.'}, {'ForeName': 'Jose Carlos', 'Initials': 'JC', 'LastName': 'Nicolau', 'Affiliation': 'Heart Institute (InCor), University of Sao Paulo Medical School, Brazil.'}, {'ForeName': 'Maria Heloisa S L', 'Initials': 'MHSL', 'LastName': 'Blotta', 'Affiliation': 'State University of Campinas (UNICAMP), Brazil.'}, {'ForeName': 'Carlos Vicente', 'Initials': 'CV', 'LastName': 'Serrano', 'Affiliation': 'Heart Institute (InCor), University of Sao Paulo Medical School, Brazil.'}]",Atherosclerosis,['10.1016/j.atherosclerosis.2006.11.032'] 1471,31285591,Randomised phase II trial of mFOLFOX6 plus bevacizumab versus mFOLFOX6 plus cetuximab as first-line treatment for colorectal liver metastasis (ATOM trial).,"BACKGROUND Chemotherapy with biologics followed by liver surgery improves the resection rate and survival of patients with colorectal liver metastasis (CRLM). However, no prospective study has compared the outcomes of chemotherapy with bevacizumab (BEV) versus cetuximab (CET). METHODS The ATOM study is the first randomised trial comparing BEV and CET for initially unresectable CRLM. Patients were randomly assigned in a 1:1 ratio to receive mFOLFOX6 plus either BEV or CET. The primary endpoint was progression-free survival (PFS). RESULTS Between May 2013 and April 2016, 122 patients were enrolled. Median PFS was 11.5 months (95% CI 9.2-13.3 months) in the BEV group and 14.8 months (95% CI 9.7-17.3 months) in the CET group (hazard ratio 0.803; P = 0.33). Patients with a smaller-number but larger-sized metastases did better in the CET group. In the BEV and CET groups, the response rates were 68.4% and 84.7% and the resection rates were 56.1% and 49.2%, respectively. CONCLUSION Although CET achieved a better response rate than BEV for patients with a small number of large liver metastases, both biologics had similar efficacy regarding liver resection and acceptable safety profiles. To achieve optimal PFS, biologics should be selected in accordance with patient conditions. TRIAL REGISTRATION This trial is registered at ClinicalTrials.gov (number NCT01836653), and UMIN Clinical Trials Registry (UMIN-CTR number UMIN000010209).",2019,Median PFS was 11.5 months (95% CI 9.2-13.3 months) in the BEV group and 14.8 months (95% CI 9.7-17.3 months) in the CET group (hazard ratio 0.803; P = 0.33).,"['Between May 2013 and April 2016, 122 patients were enrolled', 'patients with colorectal liver metastasis (CRLM']","['mFOLFOX6 plus either BEV or CET', 'CET', 'mFOLFOX6 plus bevacizumab versus mFOLFOX6 plus cetuximab', 'chemotherapy with bevacizumab (BEV) versus cetuximab (CET']","['progression-free survival (PFS', 'resection rates', 'response rates', 'response rate', 'resection rate and survival', 'Median PFS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0555952', 'cui_str': 'Colorectal (qualifier value)'}, {'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}]","[{'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0995188', 'cui_str': 'cetuximab'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]",122.0,0.166579,Median PFS was 11.5 months (95% CI 9.2-13.3 months) in the BEV group and 14.8 months (95% CI 9.7-17.3 months) in the CET group (hazard ratio 0.803; P = 0.33).,"[{'ForeName': 'Eiji', 'Initials': 'E', 'LastName': 'Oki', 'Affiliation': 'Department of Surgery and Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan. okieiji@surg2.med.kyushu-u.ac.jp.'}, {'ForeName': 'Yasunori', 'Initials': 'Y', 'LastName': 'Emi', 'Affiliation': 'Department of Surgery, Saiseikai Fukuoka General Hospital, Fukuoka, Japan.'}, {'ForeName': 'Takeharu', 'Initials': 'T', 'LastName': 'Yamanaka', 'Affiliation': 'Department of Biostatistics, Yokohama City University, Yokohama, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Uetake', 'Affiliation': 'Department of Surgical Oncology and Gastroenterology, Tokyo Medical and Dental University, Tokyo, Japan.'}, {'ForeName': 'Kei', 'Initials': 'K', 'LastName': 'Muro', 'Affiliation': 'Department of Clinical Oncology, Aichi Cancer Center Hospital, Nagoya, Japan.'}, {'ForeName': 'Takao', 'Initials': 'T', 'LastName': 'Takahashi', 'Affiliation': 'Department of Surgical Oncology, Gifu University Graduate School of Medicine, Gifu, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Nagasaka', 'Affiliation': 'Department of Clinical Oncology, Kawasaki Medical School, Kurashiki, Japan.'}, {'ForeName': 'Etsuro', 'Initials': 'E', 'LastName': 'Hatano', 'Affiliation': 'Department of Hepato-Biliary-Pancreatic Surgery, Hyogo College of Medicine, Nishinomiya, Japan.'}, {'ForeName': 'Hitoshi', 'Initials': 'H', 'LastName': 'Ojima', 'Affiliation': 'Department of Surgery, Gunma Prefectural Cancer Center, Ota, Japan.'}, {'ForeName': 'Dai', 'Initials': 'D', 'LastName': 'Manaka', 'Affiliation': 'Department of Surgery, Kyoto Katsura Hospital, Kyoto, Japan.'}, {'ForeName': 'Tetsuya', 'Initials': 'T', 'LastName': 'Kusumoto', 'Affiliation': 'Department of Surgery, National Kyushu Medical Center, Fukuoka, Japan.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Katayose', 'Affiliation': 'Department of Hepatobiliary and Pancreatic, Tohoku Medical and Pharmaceutical University, Sendai, Japan.'}, {'ForeName': 'Toshiyoshi', 'Initials': 'T', 'LastName': 'Fujiwara', 'Affiliation': 'Department of Gastroenterological Surgery, Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences, Okayama, Japan.'}, {'ForeName': 'Kazuhiro', 'Initials': 'K', 'LastName': 'Yoshida', 'Affiliation': 'Department of Surgical Oncology, Gifu University Graduate School of Medicine, Gifu, Japan.'}, {'ForeName': 'Michiaki', 'Initials': 'M', 'LastName': 'Unno', 'Affiliation': 'Department of Surgery, Tohoku University, Graduate School of Medicine, Sendai, Japan.'}, {'ForeName': 'Ichinosuke', 'Initials': 'I', 'LastName': 'Hyodo', 'Affiliation': 'Division of Gastroenterology, Faculty of Medicine, University of Tsukuba, Tsukuba, Japan.'}, {'ForeName': 'Naohiro', 'Initials': 'N', 'LastName': 'Tomita', 'Affiliation': 'Divison of Lower GI Surgery, Department of Surgery, Hyogo College of Medicine, Nishinomiya, Japan.'}, {'ForeName': 'Kenichi', 'Initials': 'K', 'LastName': 'Sugihara', 'Affiliation': 'Department of Surgical Oncology and Gastroenterology, Tokyo Medical and Dental University, Tokyo, Japan.'}, {'ForeName': 'Yoshihiko', 'Initials': 'Y', 'LastName': 'Maehara', 'Affiliation': 'Kyushu Central Hospital of the Mutual Aid Association of Public School Teachers, Fukuoka, Japan.'}]",British journal of cancer,['10.1038/s41416-019-0518-2'] 1472,32124549,Do children and adolescents with completely resected alveolar rhabdomyosarcoma require adjuvant radiation? A report from the Children's Oncology Group.,"BACKGROUND The role of adjuvant radiotherapy (RT) remains unclear in patients with localized, completely resected (group I) alveolar rhabdomyosarcoma (ARMS). PROCEDURE Patients with group I ARMS enrolled on any one of three prior Children's Oncology Group (COG) clinical trials (D9602, D9803, or ARST0531) were analyzed. All patients received systemic chemotherapy and 36 Gy adjuvant RT (if given) to the primary site at week 12 or week 4 for D9602/D9803 and ARST0531, respectively. RESULTS Thirty-six patients with group I ARMS were treated on D9602 (n = 6), D9803 (n = 17), or ARST0531 (n = 13), of whom 24 (67%) were male. The median age was 4.1 years (range, 0.8-45.8). Twenty (56%) patients had an unfavorable primary site, and 10 (28%) had tumors > 5 cm. FOXO1-fusion status was negative, positive, and unknown in 10 (28%), 15 (42%), and 11 (30%) tumors, respectively. Twenty-two (61%) patients received RT. Overall, the four-year event-free survival (EFS) and overall survival (OS) were 70.8% and 88.3%, respectively. Patients with FOXO1 positivity who received RT had superior EFS compared with those who did not (77.8% vs 16.7%; P = 0.03). Among 10 patients who were FOXO1 negative, the outcome was similar with or without RT. CONCLUSIONS Although limited by a small sample size, data from this study support the routine use of adjuvant RT in patients with FOXO1-positive disease even after complete resection. Additionally, omitting adjuvant RT is rational for patients with FOXO1-negative ARMS and will be prospectively investigated in the current COG trial ARST1431.",2020,"Overall, the four-year event-free survival (EFS) and overall survival (OS) were 70.8% and 88.3%, respectively.","[""Patients with group I ARMS enrolled on any one of three prior Children's Oncology Group (COG) clinical trials (D9602, D9803, or ARST0531) were analyzed"", 'children and adolescents with completely resected alveolar rhabdomyosarcoma require adjuvant radiation', 'patients with FOXO1-positive disease even after complete resection', 'The median age was 4.1 years (range, 0.8-45.8', 'patients with localized, completely resected (group I) alveolar rhabdomyosarcoma (ARMS', 'Twenty (56%) patients had an unfavorable primary site, and 10 (28%) had tumors\xa0>\xa05\xa0cm', 'Thirty-six patients with group', '10 patients who were FOXO1 negative, the outcome was similar with or without\xa0RT']","['adjuvant radiotherapy (RT', 'systemic chemotherapy and 36\xa0Gy adjuvant RT', 'RT']","['free survival (EFS) and overall survival (OS', 'superior EFS', 'FOXO1-fusion status']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441843', 'cui_str': 'Group I (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C4554154', 'cui_str': 'Completely - dosing instruction fragment (qualifier value)'}, {'cui': 'C0206655', 'cui_str': 'Rhabdomyosarcoma 2'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517756', 'cui_str': '4.1'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C4517481', 'cui_str': '0.8'}, {'cui': 'C0392752', 'cui_str': 'Localized (qualifier value)'}, {'cui': 'C0449695', 'cui_str': 'Site of primary lesion (attribute)'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0439084', 'cui_str': '>5 (qualifier value)'}, {'cui': 'C4319606', 'cui_str': 'Thirty-six'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}]","[{'cui': 'C0242939', 'cui_str': 'Radiotherapy, Adjuvant'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C1293131', 'cui_str': 'Fusion procedure (procedure)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}]",36.0,0.138132,"Overall, the four-year event-free survival (EFS) and overall survival (OS) were 70.8% and 88.3%, respectively.","[{'ForeName': 'Jamie M', 'Initials': 'JM', 'LastName': 'Aye', 'Affiliation': ""Department of Pediatrics, Children's of Alabama, University of Alabama at Birmingham, Birmingham, Alabama.""}, {'ForeName': 'Yueh-Yun', 'Initials': 'YY', 'LastName': 'Chi', 'Affiliation': 'Department of Biostatistics, College of Public Health and Health Professions College of Medicine, University of Florida, Gainesville, Florida.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Tian', 'Affiliation': 'Department of Biostatistics, College of Public Health and Health Professions College of Medicine, University of Florida, Gainesville, Florida.'}, {'ForeName': 'Erin R', 'Initials': 'ER', 'LastName': 'Rudzinski', 'Affiliation': ""Department of Pathology, Seattle Children's Hospital, University of Washington, Seattle, Washington.""}, {'ForeName': 'Odion T', 'Initials': 'OT', 'LastName': 'Binitie', 'Affiliation': ""Department of Surgery, Johns Hopkins All Children's Hospital, St. Petersburg, Florida.""}, {'ForeName': 'Roshni', 'Initials': 'R', 'LastName': 'Dasgupta', 'Affiliation': ""Department of Pediatric General and Thoracic Surgery, Cincinnati Children's Medical Center, University of Cincinnati, Cincinnati, Ohio.""}, {'ForeName': 'Suzanne L', 'Initials': 'SL', 'LastName': 'Wolden', 'Affiliation': 'Department of Radiation Oncology, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Douglas S', 'Initials': 'DS', 'LastName': 'Hawkins', 'Affiliation': ""Department of Pediatrics, Seattle Children's Hospital, University of Washington, Seattle, Washington.""}, {'ForeName': 'Abha A', 'Initials': 'AA', 'LastName': 'Gupta', 'Affiliation': 'Department of Pediatrics, Hospital for Sick Children, University of Toronto, Toronto, Canada.'}]",Pediatric blood & cancer,['10.1002/pbc.28243'] 1473,17150221,Inhibition of phosphodiesterase type 5 with tadalafil is associated to an improved activity of circulating angiogenic cells in men with cardiovascular risk factors and erectile dysfunction.,"Circulating angiogenic cells (CACs) contribute to repair of the vessel wall and dysfunctional CACs are associated to endothelial dysfunction in men with vascular risk factors (VRFs). We investigated whether inhibition of phosphodiesterase type 5 (PDE5) in men with erectile dysfunction (ED) and VRFs is accompanied to changes of CACs and to changes of endothelial function. Thirty-six men with ED and VRFs were randomised to 4 weeks of tadalafil (20mg/other day) or placebo treatment. The number of ex vivo expanded functional CAC's, identified by uptake of 1,1'-dioctadecyl-3, 3,3', 3'-tetramethylindocarbocyanine-labelled acetylated low-density lipoprotein (DiLDL) and concomitant Ulex europaeus agglutinin I (UEA-1) binding, was determined at baseline and after treatment. The number of cells double positive for DiLDL and for UEA-1, per high-power field fluorescence microscopy was significantly reduced in patients compared to 10 controls (26.88+/-6.3 and 74.41+/-17.1, respectively; P<0.0001) and was markedly increased after tadalafil treatment (40.69+/-13.07 versus 25.82+/-6.49; P<0.0001). The percentage variation of CACs number and of flow-mediated dilation in the brachial artery by ultrasound after treatment was significantly associated to the presence of endothelial dysfunction at baseline. In conclusion, the increased number of functional CACs after tadalafil treatment suggests a beneficial effect of prolonged PDE5 inhibition on vascular homeostasis.",2008,The percentage variation of CACs number and of flow-mediated dilation in the brachial artery by ultrasound after treatment was significantly associated to the presence of endothelial dysfunction at baseline.,"['men with vascular risk factors (VRFs', 'men with erectile dysfunction (ED) and VRFs', 'men with cardiovascular risk factors and erectile dysfunction', 'Thirty-six men with ED and VRFs']","['phosphodiesterase type 5 (PDE5', 'tadalafil', 'placebo']","[""number of ex vivo expanded functional CAC's"", 'percentage variation of CACs number and of flow-mediated dilation', 'number of cells double positive for DiLDL and for UEA-1, per high-power field fluorescence microscopy']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0242350', 'cui_str': 'Male Sexual Impotence'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C4319606', 'cui_str': 'Thirty-six'}]","[{'cui': 'C0757672', 'cui_str': 'Phosphodiesterase Type 5'}, {'cui': 'C1176316', 'cui_str': 'tadalafil'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0205229', 'cui_str': 'Expanding (qualifier value)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0205419', 'cui_str': 'Variant (qualifier value)'}, {'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}, {'cui': 'C1322279', 'cui_str': 'Dilation'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C1269099', 'cui_str': 'Ulex europeaus I'}, {'cui': 'C0439530', 'cui_str': 'per high power field'}, {'cui': 'C0026022', 'cui_str': 'Microscopy, Fluorescence'}]",36.0,0.172546,The percentage variation of CACs number and of flow-mediated dilation in the brachial artery by ultrasound after treatment was significantly associated to the presence of endothelial dysfunction at baseline.,"[{'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Bocchio', 'Affiliation': ""Department of Internal Medicine, University of L'Aquila, Italy.""}, {'ForeName': 'Fiore', 'Initials': 'F', 'LastName': 'Pelliccione', 'Affiliation': ""Department of Internal Medicine, University of L'Aquila, Italy.""}, {'ForeName': 'Gabriella', 'Initials': 'G', 'LastName': 'Passaquale', 'Affiliation': ""Department of Internal Medicine, University of L'Aquila, Italy.""}, {'ForeName': 'Radu', 'Initials': 'R', 'LastName': 'Mihalca', 'Affiliation': ""Department of Internal Medicine, University of L'Aquila, Italy.""}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Necozione', 'Affiliation': ""Department of Internal Medicine, University of L'Aquila, Italy.""}, {'ForeName': 'Giovambattista', 'Initials': 'G', 'LastName': 'Desideri', 'Affiliation': ""Department of Internal Medicine, University of L'Aquila, Italy.""}, {'ForeName': 'Felice', 'Initials': 'F', 'LastName': 'Francavilla', 'Affiliation': ""Department of Internal Medicine, University of L'Aquila, Italy.""}, {'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Ferri', 'Affiliation': ""Department of Internal Medicine, University of L'Aquila, Italy.""}, {'ForeName': 'Sandro', 'Initials': 'S', 'LastName': 'Francavilla', 'Affiliation': ""Department of Internal Medicine, University of L'Aquila, Italy. Electronic address: sandrof@univaq.it.""}]",Atherosclerosis,['10.1016/j.atherosclerosis.2006.09.035'] 1474,32142507,Evaluation of a very brief pedometer-based physical activity intervention delivered in NHS Health Checks in England: The VBI randomised controlled trial.,"BACKGROUND The majority of people do not achieve recommended levels of physical activity. There is a need for effective, scalable interventions to promote activity. Self-monitoring by pedometer is a potentially suitable strategy. We assessed the effectiveness and cost-effectiveness of a very brief (5-minute) pedometer-based intervention ('Step It Up') delivered as part of National Health Service (NHS) Health Checks in primary care. METHODS AND FINDINGS The Very Brief Intervention (VBI) Trial was a two parallel-group, randomised controlled trial (RCT) with 3-month follow-up, conducted in 23 primary care practices in the East of England. Participants were 1,007 healthy adults aged 40 to 74 years eligible for an NHS Health Check. They were randomly allocated (1:1) using a web-based tool between October 1, 2014, and December 31, 2015, to either intervention (505) or control group (502), stratified by primary care practice. Participants were aware of study group allocation. Control participants received the NHS Health Check only. Intervention participants additionally received Step It Up: a 5-minute face-to-face discussion, written materials, pedometer, and step chart. The primary outcome was accelerometer-based physical activity volume at 3-month follow-up adjusted for sex, 5-year age group, and general practice. Secondary outcomes included time spent in different intensities of physical activity, self-reported physical activity, and economic measures. We conducted an in-depth fidelity assessment on a subsample of Health Check consultations. Participants' mean age was 56 years, two-thirds were female, they were predominantly white, and two-thirds were in paid employment. The primary outcome was available in 859 (85.3%) participants. There was no significant between-group difference in activity volume at 3 months (adjusted intervention effect 8.8 counts per minute [cpm]; 95% CI -18.7 to 36.3; p = 0.53). We found no significant between-group differences in the secondary outcomes of step counts per day, time spent in moderate or vigorous activity, time spent in vigorous activity, and time spent in moderate-intensity activity (accelerometer-derived variables); as well as in total physical activity, home-based activity, work-based activity, leisure-based activity, commuting physical activity, and screen or TV time (self-reported physical activity variables). Of the 505 intervention participants, 491 (97%) received the Step it Up intervention. Analysis of 37 intervention consultations showed that 60% of Step it Up components were delivered faithfully. The intervention cost £18.04 per participant. Incremental cost to the NHS per 1,000-step increase per day was £96 and to society was £239. Adverse events were reported by 5 intervention participants (of which 2 were serious) and 5 control participants (of which 2 were serious). The study's limitations include a participation rate of 16% and low return of audiotapes by practices for fidelity assessment. CONCLUSIONS In this large well-conducted trial, we found no evidence of effect of a plausible very brief pedometer intervention embedded in NHS Health Checks on objectively measured activity at 3-month follow-up. TRIAL REGISTRATION Current Controlled Trials (ISRCTN72691150).",2020,There was no significant between-group difference in activity volume at 3 months (adjusted intervention effect 8.8 counts per minute [cpm]; 95% CI -18.7 to 36.3; p = 0.53).,"[""Participants' mean age was 56 years, two-thirds were female, they were predominantly white, and two-thirds were in paid employment"", 'England', 'Participants were 1,007 healthy adults aged 40 to 74 years eligible for an NHS Health Check', '23 primary care practices in the East of England']","['NHS Health Check only', 'very brief pedometer-based physical activity intervention', ""very brief (5-minute) pedometer-based intervention ('Step It Up') delivered as part of National Health Service (NHS""]","['Adverse events', 'activity volume', 'accelerometer-based physical activity volume', 'Incremental cost', 'effectiveness and cost-effectiveness', 'step counts per day, time spent in moderate or vigorous activity, time spent in vigorous activity, and time spent in moderate-intensity activity (accelerometer-derived variables); as well as in total physical activity, home-based activity, work-based activity, leisure-based activity, commuting physical activity, and screen or TV time (self-reported physical activity variables', 'time spent in different intensities of physical activity, self-reported physical activity, and economic measures']","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205437', 'cui_str': 'Third (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C1320371', 'cui_str': 'In paid employment'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0454366', 'cui_str': 'Step ups (regime/therapy)'}, {'cui': 'C1292711', 'cui_str': 'Part of (attribute)'}, {'cui': 'C0027462', 'cui_str': 'Health Services, National'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C0439505', 'cui_str': 'per day'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0086542', 'cui_str': 'Leisure'}, {'cui': 'C0009487', 'cui_str': 'Commuting'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C0013557', 'cui_str': 'economics'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}]",1007.0,0.0874277,There was no significant between-group difference in activity volume at 3 months (adjusted intervention effect 8.8 counts per minute [cpm]; 95% CI -18.7 to 36.3; p = 0.53).,"[{'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Hardeman', 'Affiliation': 'Behavioural and Implementation Science Group, School of Health Sciences, University of East Anglia, Norwich Research Park, Norwich, United Kingdom.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Mitchell', 'Affiliation': 'Behavioural Science Group, Primary Care Unit, Department of Public Health and Primary Care, Cambridge Institute of Public Health, Cambridge, United Kingdom.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Pears', 'Affiliation': 'Behavioural Science Group, Primary Care Unit, Department of Public Health and Primary Care, Cambridge Institute of Public Health, Cambridge, United Kingdom.'}, {'ForeName': 'Miranda', 'Initials': 'M', 'LastName': 'Van Emmenis', 'Affiliation': 'Behavioural Science Group, Primary Care Unit, Department of Public Health and Primary Care, Cambridge Institute of Public Health, Cambridge, United Kingdom.'}, {'ForeName': 'Florence', 'Initials': 'F', 'LastName': 'Theil', 'Affiliation': 'Behavioural Science Group, Primary Care Unit, Department of Public Health and Primary Care, Cambridge Institute of Public Health, Cambridge, United Kingdom.'}, {'ForeName': 'Vijay S', 'Initials': 'VS', 'LastName': 'Gc', 'Affiliation': 'Health Economics Group, Norwich Medical School, University of East Anglia, Norwich, United Kingdom.'}, {'ForeName': 'Joana C', 'Initials': 'JC', 'LastName': 'Vasconcelos', 'Affiliation': 'Imperial Clinical Trials Unit, Imperial College London, London, United Kingdom.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Westgate', 'Affiliation': 'MRC Epidemiology Unit, University of Cambridge, Cambridge, United Kingdom.'}, {'ForeName': 'Søren', 'Initials': 'S', 'LastName': 'Brage', 'Affiliation': 'MRC Epidemiology Unit, University of Cambridge, Cambridge, United Kingdom.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Suhrcke', 'Affiliation': 'Centre for Health Economics, University of York, York, United Kingdom.'}, {'ForeName': 'Simon J', 'Initials': 'SJ', 'LastName': 'Griffin', 'Affiliation': 'MRC Epidemiology Unit, University of Cambridge, Cambridge, United Kingdom.'}, {'ForeName': 'Ann Louise', 'Initials': 'AL', 'LastName': 'Kinmonth', 'Affiliation': 'Primary Care Unit, Department of Public Health and Primary Care, Cambridge Institute of Public Health, Cambridge, United Kingdom.'}, {'ForeName': 'Edward C F', 'Initials': 'ECF', 'LastName': 'Wilson', 'Affiliation': 'Health Economics Group, Norwich Medical School, University of East Anglia, Norwich, United Kingdom.'}, {'ForeName': 'A Toby', 'Initials': 'AT', 'LastName': 'Prevost', 'Affiliation': 'Imperial Clinical Trials Unit, Imperial College London, London, United Kingdom.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Sutton', 'Affiliation': 'Behavioural Science Group, Primary Care Unit, Department of Public Health and Primary Care, Cambridge Institute of Public Health, Cambridge, United Kingdom.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",PLoS medicine,['10.1371/journal.pmed.1003046'] 1475,31519466,Effects of an Evidence-Informed Healthy Eating Blog on Dietary Intakes and Food-Related Behaviors of Mothers of Preschool- and School-Aged Children: A Randomized Controlled Trial.,"BACKGROUND Although social media such as blogs are still considered innovative communication technologies, some registered dietitians (RDs) are using them to promote healthy eating; however, evidence regarding the effects of healthy eating blogs on users' diet is lacking. OBJECTIVE This study evaluated the effects of an evidence-informed healthy eating blog written by an RD on dietary intakes, with a focus on vegetables and fruit and milk and alternatives consumption, and food-related behaviors of Canadian mothers. DESIGN This study was a parallel, randomized, controlled trial. PARTICIPANTS/SETTING Data were collected from 84 French-speaking adult mothers of children aged between 2 and 12 years living in Quebec City, Quebec, Canada, who were recruited between October 2015 and February 2017 using institutional e-mail lists, flyers, newspapers, social media advertisements, and word of mouth. INTERVENTION The intervention was exclusively delivered through an evidence-informed healthy eating blog-integrating theory-based intervention methods to improve diet quality by increasing vegetables and fruit and milk and alternatives consumption in mothers-for 6 months at a dose of one new post written by an RD each week. Mothers could engage with the RD and fellow participants by posting comments on the blog. MAIN OUTCOME MEASURES Main outcomes were daily intakes of vegetables and fruit and milk and alternatives. Outcome assessments were performed at baseline, 3 months, and at the end of the 6-month intervention. STATISTICAL ANALYSIS Differences between the groups were examined using mixed linear models. RESULTS At 6 months, no significant difference was observed between groups for intakes of vegetables and fruit (P=0.923), milk and alternatives (P=0.271), or food-related behaviors and body weight (P=0.180). CONCLUSIONS A healthy eating blog, at a dose of 1 post per week, had no effects on dietary intakes, food-related behaviors, and body weight of mothers after 6 months. Methodologic issues are discussed to inform future health behavior research using blogs to promote healthy eating.",2020,"At 6 months, no significant difference was observed between groups for intakes of vegetables and fruit (P=0.923), milk and alternatives (P=0.271), or food-related behaviors and body weight (P=0.180). ","['Data were collected from 84 French-speaking adult mothers of children aged between 2 and 12 years living in Quebec City, Quebec, Canada, who were recruited between October 2015 and February 2017 using institutional e-mail lists, flyers, newspapers, social media advertisements, and word of mouth', 'Mothers of Preschool- and School-Aged Children', 'Canadian mothers']","['evidence-informed healthy eating blog-integrating theory-based intervention methods to improve diet quality by increasing vegetables and fruit and milk and alternatives consumption', 'Evidence-Informed Healthy Eating Blog']","['daily intakes of vegetables and fruit and milk and alternatives', 'dietary intakes, food-related behaviors, and body weight of mothers', 'intakes of vegetables and fruit (P=0.923), milk and alternatives (P=0.271), or food-related behaviors and body weight']","[{'cui': 'C1556084', 'cui_str': 'French (ethnic group)'}, {'cui': 'C0234856', 'cui_str': 'Using spoken communication'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0034390', 'cui_str': 'Quebec'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0013849', 'cui_str': 'Email'}, {'cui': 'C0027989', 'cui_str': 'Newspapers'}, {'cui': 'C3179065', 'cui_str': 'Social Media'}, {'cui': 'C0949214', 'cui_str': 'Advertisements'}, {'cui': 'C0230028', 'cui_str': 'Structure of oral region of face'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0238884', 'cui_str': 'Canadian'}]","[{'cui': 'C0700287', 'cui_str': 'Informing (procedure)'}, {'cui': 'C0452415', 'cui_str': 'Healthy Diet'}, {'cui': 'C2718046', 'cui_str': 'Blog'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0042440', 'cui_str': 'Vegetables'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]","[{'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0042440', 'cui_str': 'Vegetables'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}]",,0.063081,"At 6 months, no significant difference was observed between groups for intakes of vegetables and fruit (P=0.923), milk and alternatives (P=0.271), or food-related behaviors and body weight (P=0.180). ","[{'ForeName': 'Audrée-Anne', 'Initials': 'AA', 'LastName': 'Dumas', 'Affiliation': ''}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Lemieux', 'Affiliation': ''}, {'ForeName': 'Annie', 'Initials': 'A', 'LastName': 'Lapointe', 'Affiliation': ''}, {'ForeName': 'Véronique', 'Initials': 'V', 'LastName': 'Provencher', 'Affiliation': ''}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Robitaille', 'Affiliation': ''}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Desroches', 'Affiliation': ''}]",Journal of the Academy of Nutrition and Dietetics,['10.1016/j.jand.2019.05.016'] 1476,31915550,Pharmacist Led Intervention on Inhalation Technique among Asthmatic Patients for Improving Quality of Life in a Private Hospital of Nepal.,"Purpose Asthma is a chronic disease which cannot be cured but can be controlled. Although drug therapy is used to relieve and prevent symptoms of asthma and treat exacerbations, still a good asthma control and a better quality of life in many patients is suboptimal due to improper use of inhalation technique. Thus, this interventional study was conducted to evaluate the effect of a pharmacist intervention on asthma control, quality of life and inhaler technique in adult asthmatic patients. Patients and Methods A total of 72 patients who met the inclusion criteria and agreed to give written consent were enrolled in the study. These patients were randomly divided into two groups i.e., test group (36) and control group (36) by simple block randomization technique. Test group were the interventional groups. Mini Asthma Quality of Life Questionnaire (AQLQ), Asthma Control Questionnaire (ACQ) and structured questionnaires were used to sort the information like quality of life, asthma control and demographic details. They were counselled by the pharmacist about the asthma management and proper use of inhalers. Out of 72 patients, only forty six patients came for follow up after one month. Data were entered and analyzed using Statistical Package for Social Sciences (SPSS) software version 20. Results A significant change was observed in the mean score of quality of life ( p = 0.001) in test group as well as control group, however change in the mean score of asthma control in the test group ( p = 0.001) was more significant as compared to the control group ( p = 0.099). Inhalation technique was found to be improved significantly after intervention among patients using the metered dose inhaler and dry powder inhaler. Majority of the patients were prescribed with Methylxanthines (24.5%) followed by combined Beta 2 agonists and Inhaled Corticosteroids (21.7%). Conclusion Pharmacist provided intervention improves the quality of life, asthma control and inhalation technique among asthmatic patients.",2019,Inhalation technique was found to be improved significantly after intervention among patients using the metered dose inhaler and dry powder inhaler.,"['72 patients, only forty six patients came for follow up after one month', 'adult asthmatic patients', 'Patients and Methods\n\n\nA total of 72 patients who met the inclusion criteria and agreed to give written consent were enrolled in the study', 'asthmatic patients', 'Asthmatic Patients for Improving Quality of Life in a Private Hospital of Nepal']","['Pharmacist Led Intervention', 'pharmacist intervention', 'control group (36) by simple block randomization technique', 'Methylxanthines']","['mean score of quality of life', 'information like quality of life, asthma control and demographic details', 'Mini Asthma Quality of Life Questionnaire (AQLQ), Asthma Control Questionnaire (ACQ) and structured questionnaires', 'quality of life, asthma control and inhalation technique', 'mean score of asthma control', 'asthma control, quality of life and inhaler technique']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0960273', 'cui_str': 'CAME'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C4082115', 'cui_str': 'One month (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0033173', 'cui_str': 'Hospitals, Private'}, {'cui': 'C0027689', 'cui_str': 'Federal Democratic Republic of Nepal'}]","[{'cui': 'C0031323', 'cui_str': 'Pharmacist'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205352', 'cui_str': 'Simple (qualifier value)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0066447', 'cui_str': 'methylxanthine'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0004096', 'cui_str': 'Asthma, Bronchial'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C2919855', 'cui_str': 'Mini asthma quality of life questionnaire'}, {'cui': 'C2919686', 'cui_str': 'Asthma control questionnaire'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1998547', 'cui_str': 'Inhalation technique (qualifier value)'}, {'cui': 'C0021461', 'cui_str': 'Inhalators'}, {'cui': 'C0025664', 'cui_str': 'techniques'}]",72.0,0.0185566,Inhalation technique was found to be improved significantly after intervention among patients using the metered dose inhaler and dry powder inhaler.,"[{'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Yadav', 'Affiliation': 'Pharmaceutical Sciences Program, School of Health and Allied Sciences, Pokhara University, Pokhara-30, Kaski, ZIP/Post code 33700, Nepal.'}, {'ForeName': 'Parbati', 'Initials': 'P', 'LastName': 'Thapa', 'Affiliation': 'Pharmaceutical Sciences Program, School of Health and Allied Sciences, Pokhara University, Pokhara-30, Kaski, ZIP/Post code 33700, Nepal.'}]",Pulmonary medicine,['10.1155/2019/8217901'] 1477,17141245,Long-term effects of pravastatin and fosinopril on peripheral endothelial function in albuminuric subjects.,"The purpose of this double-blind, randomized, placebo-controlled trial was to determine the long-term effects of pravastatin and fosinopril treatment on peripheral endothelial function in subjects with albuminuria. Subjects (mean age 51 years, 63% male) were randomized to pravastatin 40 mg or matching placebo and to fosinopril 20mg or matching placebo. Using high resolution ultrasound, flow-mediated dilation (FMD) and nitroglycerin-induced dilation (NID) was assessed at baseline and after 4 years of treatment in a total of 276 subjects. At baseline, mean+/-standard error FMD was 4.73+/-0.49% and NID was 10.86+/-0.67%. Pravastatin significantly reduced total cholesterol and LDL cholesterol (p<0.01) and randomization to pravastatin was associated with a non-significant improvement of 18.9% in FMD (+0.80+/-0.95, p=0.09), without a significant change in NID. Interestingly, pravastatin significantly increased FMD by 34.9% in men (+1.23, p=0.04), but only 1.1% in women (+0.06, p=0.95). Fosinopril was not associated with a change in FMD or NID despite significantly decreasing urinary albumin excretion, systolic and diastolic blood pressure (all p<0.01). In conclusion, after 4 years of follow-up, pravastatin treatment tended to increase FMD and this effect was predominantly present in men. Fosinopril treatment did not modify FMD during long-term follow-up.",2008,"Pravastatin significantly reduced total cholesterol and LDL cholesterol (p<0.01) and randomization to pravastatin was associated with a non-significant improvement of 18.9% in FMD (+0.80+/-0.95, p=0.09), without a significant change in NID.","['Subjects (mean age 51 years, 63% male', 'albuminuric subjects', 'subjects with albuminuria']","['placebo', 'pravastatin 40 mg or matching placebo and to fosinopril 20mg or matching placebo', 'pravastatin and fosinopril', 'Fosinopril treatment', 'pravastatin and fosinopril treatment', 'Pravastatin', 'pravastatin']","['urinary albumin excretion, systolic and diastolic blood pressure', 'total cholesterol and LDL cholesterol', 'FMD', 'NID', 'mean+/-standard error FMD', 'peripheral endothelial function', 'flow-mediated dilation (FMD) and nitroglycerin-induced dilation (NID']","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0001925', 'cui_str': 'Albuminuria'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0085542', 'cui_str': 'Pravastatin'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0118168', 'cui_str': 'Fosinopril'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C3711292', 'cui_str': '68Ga-albumin'}, {'cui': 'C0221102', 'cui_str': 'Excretory function (observable entity)'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205100', 'cui_str': 'Peripheral (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}, {'cui': 'C1322279', 'cui_str': 'Dilation'}, {'cui': 'C0017887', 'cui_str': 'glyceryl trinitrate'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}]",276.0,0.329952,"Pravastatin significantly reduced total cholesterol and LDL cholesterol (p<0.01) and randomization to pravastatin was associated with a non-significant improvement of 18.9% in FMD (+0.80+/-0.95, p=0.09), without a significant change in NID.","[{'ForeName': 'Folkert W', 'Initials': 'FW', 'LastName': 'Asselbergs', 'Affiliation': 'Department of Cardiology, University Medical Center Groningen, Groningen, The Netherlands. Electronic address: fwasselbergs@hotmail.com.'}, {'ForeName': 'Pim', 'Initials': 'P', 'LastName': 'van der Harst', 'Affiliation': 'Department of Cardiology, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Arie M', 'Initials': 'AM', 'LastName': 'van Roon', 'Affiliation': 'Department of Internal Medicine, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Hans L', 'Initials': 'HL', 'LastName': 'Hillege', 'Affiliation': 'Department of Cardiology, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Paul E', 'Initials': 'PE', 'LastName': 'de Jong', 'Affiliation': 'Department of Internal Medicine, Division of Nephrology, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Reinold O B', 'Initials': 'ROB', 'LastName': 'Gans', 'Affiliation': 'Department of Internal Medicine, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Andries J', 'Initials': 'AJ', 'LastName': 'Smit', 'Affiliation': 'Department of Internal Medicine, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Wiek H', 'Initials': 'WH', 'LastName': 'van Gilst', 'Affiliation': 'Department of Cardiology, University Medical Center Groningen, Groningen, The Netherlands; Department of Clinical Pharmacology, University Medical Center Groningen, Groningen, The Netherlands.'}]",Atherosclerosis,['10.1016/j.atherosclerosis.2006.11.011'] 1478,17157857,"The new oral immunomodulating drug DiNAC induces brachial artery vasodilatation at rest and during hyperemia in hypercholesterolemic subjects, likely by a nitric oxide-dependent mechanism.","OBJECTIVES To investigate if the immunomodulator drug DINAC (1) affects arterial dimensions in asymptomatic patients with hypercholesterolemia, (2) has effects on leucocyte markers of inflammation and (3) has in vitro effects on nitric oxide synthase (NOS) in human umbilical vein endothelial cells (HUVEC). METHODS AND RESULTS One hundred and fifty-three patients with asymptomatic hypercholesterolemia were randomized to either 100 or 500 mg of DINAC or placebo in a double-blind, parallel-group fashion for 24 weeks. Treatment at the highest dose induced a significant increase in resting brachial artery diameter measured by ultrasound and also induced a significant increase in vessel diameter during hyperemia. However, flow-mediated vasodilation (FMD) and the vasodilatory response to nitroglycerin, lipid levels or leukocyte count were unaltered. Expression of several cell surface markers of inflammation, like CD11b and CD25, were reduced by treatment. In vitro, DINAC counteracted TNF-alpha induced reductions in NO levels and in NOS protein and mRNA levels. CONCLUSION The immunomodulator drug DINAC increased brachial artery diameter at rest and during hyperemia in asymptomatic subjects with hypercholesterolemia without affecting blood lipid levels. Based on parallel in vitro studies this effect is likely due to an enhancement of NOS activity.",2008,Treatment at the highest dose induced a significant increase in resting brachial artery diameter measured by ultrasound and also induced a significant increase in vessel diameter during hyperemia.,"['hypercholesterolemic subjects', 'asymptomatic subjects with hypercholesterolemia without affecting blood lipid levels', 'asymptomatic patients with hypercholesterolemia, (2', 'One hundred and fifty-three patients with asymptomatic hypercholesterolemia']",['DINAC or placebo'],"['flow-mediated vasodilation (FMD) and the vasodilatory response to nitroglycerin, lipid levels or leukocyte count', 'brachial artery vasodilatation', 'Expression of several cell surface markers of inflammation, like CD11b and CD25', 'brachial artery diameter', 'vessel diameter during hyperemia', 'resting brachial artery diameter']","[{'cui': 'C0231221', 'cui_str': 'Asymptomatic (finding)'}, {'cui': 'C0020443', 'cui_str': 'High Cholesterol Levels'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}, {'cui': 'C0005768'}, {'cui': 'C0428460', 'cui_str': 'Finding of lipid level (finding)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}, {'cui': 'C0042401', 'cui_str': 'Vasorelaxation'}, {'cui': 'C0017887', 'cui_str': 'glyceryl trinitrate'}, {'cui': 'C0428460', 'cui_str': 'Finding of lipid level (finding)'}, {'cui': 'C0023508', 'cui_str': 'Blood Cell Count, White'}, {'cui': 'C0006087', 'cui_str': 'Brachial Artery'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0205148', 'cui_str': 'Surface (attribute)'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C1301886', 'cui_str': 'Diameter (qualifier value)'}, {'cui': 'C0148346', 'cui_str': 'Vessel'}, {'cui': 'C0020452', 'cui_str': 'Hyperemia'}, {'cui': 'C0035253', 'cui_str': 'Rest'}]",153.0,0.075114,Treatment at the highest dose induced a significant increase in resting brachial artery diameter measured by ultrasound and also induced a significant increase in vessel diameter during hyperemia.,"[{'ForeName': 'Knut', 'Initials': 'K', 'LastName': 'Pettersson', 'Affiliation': 'AstraZeneca R&D Mölndal, Mölndal, Sweden.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Kjerrulf', 'Affiliation': 'AstraZeneca R&D Mölndal, Mölndal, Sweden.'}, {'ForeName': 'Lennart', 'Initials': 'L', 'LastName': 'Jungersten', 'Affiliation': 'Department of Clinical Pharmacology, Sahlgrenska University Hospital, Göteborg, Sweden.'}, {'ForeName': 'Kicki', 'Initials': 'K', 'LastName': 'Johansson', 'Affiliation': 'AstraZeneca R&D Mölndal, Mölndal, Sweden.'}, {'ForeName': 'Göran', 'Initials': 'G', 'LastName': 'Långström', 'Affiliation': 'AstraZeneca R&D Mölndal, Mölndal, Sweden.'}, {'ForeName': 'Inge', 'Initials': 'I', 'LastName': 'Kalies', 'Affiliation': 'AstraZeneca R&D Mölndal, Mölndal, Sweden.'}, {'ForeName': 'Rodica', 'Initials': 'R', 'LastName': 'Lenkei', 'Affiliation': 'Capio Diagnostik/CALAB Research, Flow Cytometry Laboratory, Stockholm, Sweden.'}, {'ForeName': 'Göran', 'Initials': 'G', 'LastName': 'Walldius', 'Affiliation': 'AstraZeneca R&D Mölndal, Mölndal, Sweden.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Lind', 'Affiliation': 'AstraZeneca R&D Mölndal, Mölndal, Sweden; Department of Medicine, University Hospital, Uppsala, Sweden. Electronic address: lars.lind@medsci.uu.se.'}]",Atherosclerosis,['10.1016/j.atherosclerosis.2006.10.031'] 1479,31845149,"Age- and Race/Ethnicity-Specific Sex Partner Correlates of Condomless Sex in an Online Sample of Hispanic/Latino, Black/African-American, and White Men Who Have Sex with Men.","We sought to identify and compare correlates of condomless receptive anal intercourse with HIV-positive or unknown status partners (CRAI) for younger (< 25 years) and older (≥ 25 years) Hispanic/Latino, black/African-American, and white men who have sex with men (MSM). Baseline data from the Evaluation of Rapid HIV Self-Testing among MSM Project (eSTAMP), a randomized controlled trial with MSM (n = 2665, analytical sample size = 2421), were used. Potential correlates included participants' sociodemographic characteristics and HIV status as well as the characteristics of participants' partners. Younger Hispanic/Latino and black men were most likely to report having older sex partners (≥ 50% of partners being at least 5 years older), and having older partners was a significant correlate of CRAI among younger Hispanic/Latino and white men. Regardless of race/ethnicity, not knowing one's HIV status was a significant correlate of CRAI among younger men, whereas having a black sex partner was a significant correlate among older men. HIV prevention initiatives could address these and other correlates specific to race/ethnicity groups to target their prevention resources and messaging.",2020,"Regardless of race/ethnicity, not knowing one's HIV status was a significant correlate of CRAI among younger men, whereas having a black sex partner was a significant correlate among older men.","['Hispanic/Latino, black/African-American, and white men who have sex with men (MSM', 'condomless receptive anal intercourse with HIV-positive or unknown status partners (CRAI) for younger (<\u200925\xa0years) and older (≥\u200925\xa0years', 'Younger Hispanic/Latino and black men', 'Age- and Race/Ethnicity-Specific Sex Partner Correlates of Condomless Sex in an Online Sample of Hispanic/Latino, Black/African-American, and White Men', 'n\u2009=\u20092665, analytical sample size\u2009=\u20092421', 'Who Have Sex with Men']","['MSM', 'MSM Project (eSTAMP']",[],"[{'cui': 'C0086409', 'cui_str': 'Hispanics'}, {'cui': 'C0086528', 'cui_str': 'Latinos'}, {'cui': 'C0439541', 'cui_str': 'Black color (qualifier value)'}, {'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}, {'cui': 'C0556628', 'cui_str': 'Anal penetration (finding)'}, {'cui': 'C0019699', 'cui_str': 'HTLV-III Seroconversion'}, {'cui': 'C0439673', 'cui_str': 'Unknown (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0682323', 'cui_str': 'Companion'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3853635', 'cui_str': 'Race (observable entity)'}, {'cui': 'C0243103', 'cui_str': 'ethnicity'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0242618', 'cui_str': 'Sample Size'}]",[],[],,0.04104,"Regardless of race/ethnicity, not knowing one's HIV status was a significant correlate of CRAI among younger men, whereas having a black sex partner was a significant correlate among older men.","[{'ForeName': 'Yuko', 'Initials': 'Y', 'LastName': 'Mizuno', 'Affiliation': 'Division of HIV/AIDS Prevention, National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, Centers for Disease Control and Prevention, 1600 Clifton Road, NE Mail Stop US8-5, Atlanta, GA, 30329, USA. ymizuno@cdc.gov.'}, {'ForeName': 'Craig B', 'Initials': 'CB', 'LastName': 'Borkowf', 'Affiliation': 'Division of HIV/AIDS Prevention, National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, Centers for Disease Control and Prevention, 1600 Clifton Road, NE Mail Stop US8-5, Atlanta, GA, 30329, USA.'}, {'ForeName': 'Sabina', 'Initials': 'S', 'LastName': 'Hirshfield', 'Affiliation': 'Department of Medicine, SUNY Downstate Medical Center, Brooklyn, NY, USA.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Mustanski', 'Affiliation': 'Northwestern University Feinberg School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Patrick S', 'Initials': 'PS', 'LastName': 'Sullivan', 'Affiliation': 'Emory University School of Public Health, Atlanta, GA, USA.'}, {'ForeName': 'Robin J', 'Initials': 'RJ', 'LastName': 'MacGowan', 'Affiliation': 'Division of HIV/AIDS Prevention, National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, Centers for Disease Control and Prevention, 1600 Clifton Road, NE Mail Stop US8-5, Atlanta, GA, 30329, USA.'}]",Archives of sexual behavior,['10.1007/s10508-019-01534-8'] 1480,31515625,"Comparison of postoperative cosmesis in transaxillary, postauricular facelift, and conventional transcervical thyroidectomy.","BACKGROUND The most important advantage of remote-access robotic and endoscopic thyroidectomies is believed to be the excellent postoperative cosmesis. The purpose of this study was to compare directly the postoperative cosmetic outcomes of robotic/endoscopic thyroidectomy via gasless transaxillary and postauricular facelift approaches with those of conventional thyroidectomy. METHODS We prospectively studied 100 patients who underwent robotic/endoscopic thyroidectomy using a gasless unilateral axillary (GUA) approach (50 patients) or a postauricular facelift approach (50 patients), and 50 who underwent conventional transcervical thyroidectomy. Postoperative cosmetic satisfaction scores and scar consciousness scores were evaluated at 3 months and 1 year after surgery using questionnaires developed by us. Vancouver scar scales were evaluated at the same time. The cosmetic satisfaction score was defined as the sum of the two cosmetic satisfaction questions with a rating scale of 1-5 each. The scar consciousness score was defined as the sum of the four scar consciousness questions with a rating scale of 0-3 each. RESULTS The cosmetic satisfaction and scar consciousness scores were significantly lower (corresponding to greater satisfaction) in the transaxillary and postauricular facelift groups than the conventional group at 3 months and 1 year postoperatively. They did not differ between the transaxillary and postauricular facelift groups. However, the Vancouver scar scale score of the conventional group was significantly lower than those of the transaxillary and postauricular facelift groups (P < 0.001 in both). CONCLUSION Robotic/endoscopic thyroidectomy via transaxillary or postauricular facelift approaches results in better cosmesis than the conventional approach. However, scar healing itself is worse in the transaxillary and facelift approaches than the conventional approach.",2020,The cosmetic satisfaction and scar consciousness scores were significantly lower (corresponding to greater satisfaction) in the transaxillary and postauricular facelift groups than the conventional group at 3 months and 1 year postoperatively.,"['100 patients who underwent', '50 patients), and 50 who underwent']","['Robotic/endoscopic thyroidectomy via transaxillary or postauricular facelift approaches', 'conventional transcervical thyroidectomy', 'robotic/endoscopic thyroidectomy using a gasless unilateral axillary (GUA) approach (50 patients) or a postauricular facelift approach', 'transaxillary, postauricular facelift, and conventional transcervical thyroidectomy', 'robotic/endoscopic thyroidectomy via gasless transaxillary and postauricular facelift approaches', 'conventional thyroidectomy']","['Vancouver scar scales', 'cosmetic satisfaction and scar consciousness scores', 'Vancouver scar scale score', 'scar healing itself', 'scar consciousness score', 'cosmetic satisfaction score', 'Postoperative cosmetic satisfaction scores and scar consciousness scores']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0040145', 'cui_str': 'Thyroidectomy'}, {'cui': 'C0442341', 'cui_str': 'Transaxillary approach (qualifier value)'}, {'cui': 'C0442168', 'cui_str': 'Postauricular (qualifier value)'}, {'cui': 'C0035519', 'cui_str': 'Facelift'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0442344', 'cui_str': 'Transcervical approach - uterine (qualifier value)'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C1562241', 'cui_str': 'Axillary approach'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0008767', 'cui_str': 'Cicatrization'}, {'cui': 'C0222045'}, {'cui': 'C0442965', 'cui_str': 'Cosmetic procedure (qualifier value)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0234421', 'cui_str': 'Consciousness'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0043240', 'cui_str': 'Wound Healing'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}]",100.0,0.0246211,The cosmetic satisfaction and scar consciousness scores were significantly lower (corresponding to greater satisfaction) in the transaxillary and postauricular facelift groups than the conventional group at 3 months and 1 year postoperatively.,"[{'ForeName': 'Dong Won', 'Initials': 'DW', 'LastName': 'Lee', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, College of Medicine, Hanyang University, 222 Wangsimni-ro, Seongdong-gu, Seoul, 04763, Republic of Korea.'}, {'ForeName': 'Seok Hwa', 'Initials': 'SH', 'LastName': 'Ko', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, College of Medicine, Hanyang University, 222 Wangsimni-ro, Seongdong-gu, Seoul, 04763, Republic of Korea.'}, {'ForeName': 'Chang Myeon', 'Initials': 'CM', 'LastName': 'Song', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, College of Medicine, Hanyang University, 222 Wangsimni-ro, Seongdong-gu, Seoul, 04763, Republic of Korea.'}, {'ForeName': 'Yong Bae', 'Initials': 'YB', 'LastName': 'Ji', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, College of Medicine, Hanyang University, 222 Wangsimni-ro, Seongdong-gu, Seoul, 04763, Republic of Korea.'}, {'ForeName': 'Jeong Kyu', 'Initials': 'JK', 'LastName': 'Kim', 'Affiliation': 'Department of Otorhinolaryngology-Head and Neck Surgery, School of Medicine, Catholic University of Daegu, Daegu, Republic of Korea.'}, {'ForeName': 'Kyung', 'Initials': 'K', 'LastName': 'Tae', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, College of Medicine, Hanyang University, 222 Wangsimni-ro, Seongdong-gu, Seoul, 04763, Republic of Korea. kytae@hanyang.ac.kr.'}]",Surgical endoscopy,['10.1007/s00464-019-07113-1'] 1481,31520149,Promoting stigma coping and empowerment in patients with schizophrenia and depression: results of a cluster-RCT.,"There is a need for interventions supporting patients with mental health conditions in coping with stigma and discrimination. A psycho-educational group therapy module to promote stigma coping and empowerment (STEM) was developed and tested for efficacy in patients with schizophrenia or depression. 30 clinical centers participated in a cluster-randomized clinical trial, representing a broad spectrum of mental health care settings: in-patient (acute treatment, rehabilitation), out-patient, and day-hospitals. As randomized, patients in the intervention group clusters/centers received an illness-specific eight sessions standard psychoeducational group therapy plus three specific sessions on stigma coping and empowerment ('STEM'). In the control group clusters the same standard psychoeducational group therapy was extended to 11 sessions followed by one booster session in both conditions. In total, N = 462 patients were included in the analysis (N = 117 with schizophrenia spectrum disorders, ICD-10 F2x; N = 345 with depression, ICD-10 F31.3-F31.5, F32-F34, and F43.2). Clinical and stigma-related measures were assessed before and directly after treatment, as well as after 6 weeks, 6 months, and 12 months (M12). Primary outcome was improvement in quality of life (QoL) assessed with the WHO-QOL-BREF between pre-assessment and M12 analyzed by mixed models and adjusted for pre-treatment differences. Overall, QoL and secondary outcome measures (symptoms, functioning, compliance, internalized stigma, self-esteem, empowerment) improved significantly, but there was no significant difference between intervention and control group. The short STEM module has proven its practicability as an add-on in different settings in routine mental health care. The overall increase in empowerment in both, schizophrenia and depression, indicates patients' treatment benefit. However, factors contributing to improvement need to be explored.The study has been registered in the following trial registers. ClinicalTrials.gov: https://register.clinicaltrials.gov/ Registration number: NCT01655368. DRKS: https://www.drks.de/drks_web/ Registration number: DRKS00004217.",2020,The short STEM module has proven its practicability as an add-on in different settings in routine mental health care.,"['patients with schizophrenia or depression', 'patients with schizophrenia and depression', '30 clinical centers participated in a cluster-randomized clinical trial, representing a broad spectrum of mental health care settings: in-patient (acute treatment, rehabilitation), out-patient, and day-hospitals', 'In total, N\u2009=\u2009462 patients were included in the analysis (N\u2009=\u2009117 with schizophrenia spectrum disorders, ICD-10 F2x; N\u2009=\u2009345 with depression, ICD-10 F31.3-F31.5, F32-F34, and F43.2']","['DRKS', ""illness-specific eight sessions standard psychoeducational group therapy plus three specific sessions on stigma coping and empowerment ('STEM""]","['quality of life (QoL) assessed with the WHO-QOL-BREF between pre-assessment and M12 analyzed by mixed models and adjusted for pre-treatment differences', 'Overall, QoL and secondary outcome measures (symptoms, functioning, compliance, internalized stigma, self-esteem, empowerment']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}, {'cui': 'C0184643', 'cui_str': 'Mental health care'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0587438', 'cui_str': 'Day hospital (environment)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1137110', 'cui_str': 'ICD-10'}]","[{'cui': 'C0221423', 'cui_str': 'Illness (finding)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1527374', 'cui_str': 'Group Therapy'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0277787', 'cui_str': 'Stigma (finding)'}, {'cui': 'C0679959', 'cui_str': 'Empowerment'}, {'cui': 'C0162731', 'cui_str': 'STEM'}]","[{'cui': 'C0034380'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0277787', 'cui_str': 'Stigma (finding)'}, {'cui': 'C0036597', 'cui_str': 'Self Esteem'}, {'cui': 'C0679959', 'cui_str': 'Empowerment'}]",462.0,0.169768,The short STEM module has proven its practicability as an add-on in different settings in routine mental health care.,"[{'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Gaebel', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Medical Faculty, Heinrich Heine University, Düsseldorf, Germany. wolfgang.gaebel@lvr.de.'}, {'ForeName': 'Harald', 'Initials': 'H', 'LastName': 'Zäske', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Medical Faculty, Heinrich Heine University, Düsseldorf, Germany.'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Hesse', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Tübingen, Tübingen, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Klingberg', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Tübingen, Tübingen, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Ohmann', 'Affiliation': 'Coordination Center for Clinical Trials, Medical Faculty, Heinrich Heine University, Düsseldorf, Germany.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Grebe', 'Affiliation': 'Coordination Center for Clinical Trials, Medical Faculty, Heinrich Heine University, Düsseldorf, Germany.'}, {'ForeName': 'Henrike', 'Initials': 'H', 'LastName': 'Kolbe', 'Affiliation': 'Coordination Center for Clinical Trials, Medical Faculty, Heinrich Heine University, Düsseldorf, Germany.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Icks', 'Affiliation': 'Institute for Health Services Research and Health Economics, Centre for Health and Society, Medical Faculty, Heinrich Heine University, Düsseldorf, Germany.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Schneider', 'Affiliation': 'Department of Psychiatry, Psychotherapy and Psychosomatics, Medical Faculty, RWTH Aachen, Aachen, Germany.'}, {'ForeName': 'Volker', 'Initials': 'V', 'LastName': 'Backes', 'Affiliation': 'Department of Psychiatry, Psychotherapy and Psychosomatics, Medical Faculty, RWTH Aachen, Aachen, Germany.'}, {'ForeName': 'Claus', 'Initials': 'C', 'LastName': 'Wolff-Menzler', 'Affiliation': 'Department of Psychiatry, University Medical Center Göttingen, Göttingen, Germany.'}, {'ForeName': 'Birgit', 'Initials': 'B', 'LastName': 'Guse', 'Affiliation': 'Department of Psychiatry, University Medical Center Göttingen, Göttingen, Germany.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Gallinat', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Bock', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Maria-Christiane', 'Initials': 'MC', 'LastName': 'Jockers-Scherübl', 'Affiliation': 'Charité Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Timo', 'Initials': 'T', 'LastName': 'Krüger', 'Affiliation': 'Charité Universitätsmedizin Berlin, Berlin, Germany.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Jessen', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Bechdolf', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Tilo', 'Initials': 'T', 'LastName': 'Kircher', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Marburg, Marburg, Germany.'}, {'ForeName': 'Carsten', 'Initials': 'C', 'LastName': 'Konrad', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Marburg, Marburg, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Falkai', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Hospital, LMU Munich, Munich, Germany.'}, {'ForeName': 'Annette', 'Initials': 'A', 'LastName': 'Schaub', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Hospital, LMU Munich, Munich, Germany.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Rudolph', 'Affiliation': 'Mittelrhein-Klinik for Psychosmatics and Rehabilitation, Bad Salzig, Germany.'}, {'ForeName': 'Volker', 'Initials': 'V', 'LastName': 'Köllner', 'Affiliation': 'Department of Psychosomatic Medicine, Mediclin Bliestal Clinic, Blieskastel, Germany.'}, {'ForeName': 'Gerhard', 'Initials': 'G', 'LastName': 'Schmid-Ott', 'Affiliation': 'Department of Psychosomatics, Berolina Clinic, Löhne, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Linden', 'Affiliation': 'Department of Behavioral Medicine, Rehabilitation Center Seehof, Teltow, Germany.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Lieberei', 'Affiliation': 'Department of Behavioral Medicine, Rehabilitation Center Seehof, Teltow, Germany.'}, {'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Stuhlinger', 'Affiliation': 'Psychiatric-Psychotherapeutic Rehabilitation Center grund.stein, Tübingen, Germany.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Sommerfeld', 'Affiliation': 'AHG Klinik, Waren, Germany.'}, {'ForeName': 'Albrecht', 'Initials': 'A', 'LastName': 'Schumacher', 'Affiliation': 'AHG Klinik, Waren, Germany.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Krenge', 'Affiliation': 'AHG Klinik, Waren, Germany.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Gereke', 'Affiliation': 'Psychiatric Practices Berlin, Berlin, Germany.'}, {'ForeName': 'Norbert', 'Initials': 'N', 'LastName': 'Mönter', 'Affiliation': 'Psychiatric Practices Berlin, Berlin, Germany.'}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Navarro-Urena', 'Affiliation': 'Psychiatric Practices Berlin, Berlin, Germany.'}, {'ForeName': 'Günter', 'Initials': 'G', 'LastName': 'Frosch', 'Affiliation': 'Psychiatric Practices Düsseldorf, Düsseldorf, Germany.'}, {'ForeName': 'Franz-Josef', 'Initials': 'FJ', 'LastName': 'Kuhlbusch', 'Affiliation': 'Psychiatric Practices Düsseldorf, Düsseldorf, Germany.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Cleveland', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Medical Faculty, Heinrich Heine University, Düsseldorf, Germany.'}, {'ForeName': 'Mathias', 'Initials': 'M', 'LastName': 'Riesbeck', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Medical Faculty, Heinrich Heine University, Düsseldorf, Germany.'}]",European archives of psychiatry and clinical neuroscience,['10.1007/s00406-019-01064-3'] 1482,31514988,"Analgesic Effect of Nitrous Oxide/Oxygen Mixture for Traumatic Pain in the Emergency Department: A Randomized, Double-Blind Study.","BACKGROUND Acute pain is the most common complaint in Emergency Department (ED) admissions, and options for analgesia are limited. Nitrous oxide/oxygen possesses many properties showing it may be an ideal analgesic in the ED. OBJECTIVES The aim of this study is to evaluate the safety and analgesic effect of the fixed nitrous oxide/oxygen mixture for trauma patients in the ED. METHODS We enrolled 60 patients in this double-blind, randomized study. The treatment group received conventional pain treatment plus a mixture of 65% nitrous oxide/oxygen. The control group received the conventional pain treatment plus oxygen. Primary outcome was the reduction in pain intensity at 5 and 15 min after the start of intervention. Secondary outcomes include adverse events, physiological parameters, and satisfaction from both patients and health care professionals. RESULTS Initial pain scores for the nitrous oxide/oxygen group (6.0 [5.0-8.0]) and the oxygen group (6.75 [5.0-9.0]) were comparable (p = 0.57). The mean numerical rating scale scores at 5 min were 3.4 ± 1.8 and 7.0 ± 1.8 for nitrous oxide/oxygen and oxygen, respectively (p < 0.01). The mean pain intensity at 15 min in the treatment group was 3.0 ± 1.9, compared with 6.3 ± 2.2 in the control group (p < 0.01). Both patients' (8.0 [7.0-9.0] vs. 4.0 [2.0-6.0], p < 0.01) and physicians' (8.5 [8.0-9.0] vs. 4.0 [3.0-6.0], p < 0.01) satisfaction scores in the treatment group were significantly higher than the oxygen group. No serious adverse events were observed. CONCLUSIONS This study gives supporting evidence for the safety and effectiveness of using self-administered nitrous oxide/oxygen mixture in the ED for moderate-to-severe traumatic pain.",2019,"The mean pain intensity at 15 min in the treatment group was 3.0 ± 1.9, compared with 6.3 ± 2.2 in the control group (p < 0.01).","['moderate-to-severe traumatic pain', 'trauma patients', 'Traumatic Pain in the Emergency Department']","['conventional pain treatment plus oxygen', 'self-administered nitrous oxide/oxygen mixture', 'nitrous oxide/oxygen', 'Nitrous Oxide/Oxygen Mixture', 'conventional pain treatment plus a mixture of 65% nitrous oxide/oxygen', 'Nitrous oxide/oxygen', 'fixed nitrous oxide/oxygen mixture']","['safety and analgesic effect', 'mean numerical rating scale scores', 'Initial pain scores', 'adverse events, physiological parameters, and satisfaction from both patients and health care professionals', 'satisfaction scores', 'reduction in pain intensity', 'serious adverse events', 'mean pain intensity']","[{'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0332663', 'cui_str': 'Traumatic (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0043251', 'cui_str': 'Trauma'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C0028215', 'cui_str': 'Nitrous Oxide'}, {'cui': 'C0439962', 'cui_str': 'Mixture (qualifier value)'}, {'cui': 'C0443218', 'cui_str': 'Fixed (qualifier value)'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0948482', 'cui_str': 'Analgesic effect'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205463', 'cui_str': 'Physiologic (qualifier value)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}]",60.0,0.256515,"The mean pain intensity at 15 min in the treatment group was 3.0 ± 1.9, compared with 6.3 ± 2.2 in the control group (p < 0.01).","[{'ForeName': 'Lu-Lu', 'Initials': 'LL', 'LastName': 'Gao', 'Affiliation': 'School of Nursing, Ningxia Medical University, Yinchuan, China.'}, {'ForeName': 'Jian-Qiang', 'Initials': 'JQ', 'LastName': 'Yu', 'Affiliation': 'Department of Pharmacology, College of Pharmacy, Ningxia Medical University, Yinchuan, China.'}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Liu', 'Affiliation': 'School of Basic Medical Sciences, Ningxia Medical University, Yinchuan, China.'}, {'ForeName': 'Hai-Xiang', 'Initials': 'HX', 'LastName': 'Gao', 'Affiliation': 'School of Nursing, Ningxia Medical University, Yinchuan, China.'}, {'ForeName': 'Ya-Liang', 'Initials': 'YL', 'LastName': 'Dai', 'Affiliation': 'School of Nursing, Ningxia Medical University, Yinchuan, China.'}, {'ForeName': 'Jun-Jun', 'Initials': 'JJ', 'LastName': 'Zhang', 'Affiliation': 'School of Nursing, Ningxia Medical University, Yinchuan, China.'}, {'ForeName': 'Yi-Ling', 'Initials': 'YL', 'LastName': 'Wang', 'Affiliation': 'School of Nursing, Ningxia Medical University, Yinchuan, China.'}, {'ForeName': 'Ting-Ting', 'Initials': 'TT', 'LastName': 'Zhang', 'Affiliation': 'School of Nursing, Ningxia Medical University, Yinchuan, China.'}, {'ForeName': 'Jian-Jun', 'Initials': 'JJ', 'LastName': 'Yang', 'Affiliation': 'School of Public Health and Preventive Medicine, Ningxia Medical University, Yinchuan, China.'}, {'ForeName': 'Yu-Xiang', 'Initials': 'YX', 'LastName': 'Li', 'Affiliation': 'School of Nursing, Ningxia Medical University, Yinchuan, China.'}]",The Journal of emergency medicine,['10.1016/j.jemermed.2019.06.026'] 1483,31515173,"Nicotine patches used in combination with e-cigarettes (with and without nicotine) for smoking cessation: a pragmatic, randomised trial.","BACKGROUND Combination nicotine replacement therapy shows additive cessation benefits. We aimed to find out the effectiveness of combining nicotine patches with an e-cigarette (with and without nicotine) on six-month smoking abstinence. METHODS We did a pragmatic, three-arm, parallel-group trial in New Zealand in adult smokers who were e-cigarette naive and motivated to quit smoking. Participants were recruited from the general population using national media advertising. Participants were randomly assigned (1:4:4), with the use of stratified block randomisation, to receive 14 weeks (2 weeks before the agreed quit date) of 21 mg, 24h nicotine patches, patches plus an 18 mg/L nicotine e-cigarette, or patches plus a nicotine-free e-cigarette. We advised participants to use one patch daily, with e-cigarette use as and when necessary or desired. Participants and researchers were masked to e-liquid nicotine content. We offered 6 weeks of telephone-delivered behavioural support. The primary outcome was exhaled carbon monoxide (CO)-verified continuous smoking abstinence 6 months after the agreed quit date. Primary analysis was by intention to treat, with sensitivity analysis by per protocol, treatment adherence, varying CO cutoffs, and complete case analysis. This paper presents the main analyses and is registered with ClinicalTrials.gov, NCT02521662. FINDINGS Between March 17, 2016 and Nov 30, 2017, 1124 people were assigned to nicotine patches (patches only group, n=125), patches plus a nicotine e-cigarette (patches plus nicotine e-cigarette group, n=500), or patches plus a nicotine-free e-cigarette (patches plus nicotine-free e-cigarette group, n=499). 62 (50%) of 125 participants in the patches only group withdrew or were lost to follow-up by 6 months compared with 161 (32%) of 500 in the patches plus nicotine e-cigarette group and 162 (33%) of 499 in the patches plus nicotine-free e-cigarette group. 35 (7%) participants in the patches plus nicotine e-cigarette group had CO-verified continuous abstinence at 6 months compared with 20 (4%) in the patches plus nicotine-free e-cigarette group (risk difference [RD] 2·99 [95% CI 0·17-5·81]), and three (2%) people in the patches only group (RD 4·60 [1·11-8·09]). 18 serious adverse events occurred in 16 people in the patches plus nicotine e-cigarette group compared with 27 events in 22 people in the patches plus nicotine-free e-cigarette group and four events in three people in the patches only group. In the patches plus nicotine e-cigarette group, two life-threatening serious adverse events were reported (two separate heart attacks in the one participant). In the patches plus nicotine-free e-cigarette group, one death occurred (accidental drug overdose) and one life-threatening serious adverse event (heart attack). No significant between-group differences were noted for serious adverse events, and none were treatment-related. INTERPRETATION Combining reduced-harm nicotine products, such as nicotine patches with a nicotine e-cigarette, can lead to a modest improvement in smoking cessation over and above that obtained from using patches plus a nicotine-free e-cigarette (or patches alone), with no indication of any serious harm in the short-term. Future e-cigarette trials should focus on their use alone or in combination with usual smoking cessation support, given issues with differential loss to follow-up and withdrawal if a usual care group is used as a comparator. FUNDING Health Research Council of New Zealand.",2020,18 serious adverse events occurred in 16 people in the patches plus nicotine e-cigarette group compared with 27 events in 22 people in the patches plus nicotine-free e-cigarette group and four events in three people in the patches only group.,"['adult smokers who were e-cigarette naive and motivated to quit smoking', 'Participants were recruited from the general population using national media advertising', '62 (50%) of 125 participants in the patches', 'Between March 17, 2016 and Nov 30, 2017, 1124 people were assigned to']","['nicotine e-cigarette', 'nicotine-free e-cigarette group', 'nicotine patches, patches plus an 18 mg/L nicotine e-cigarette, or patches plus a nicotine-free e-cigarette', 'nicotine patches with an e-cigarette (with and without nicotine', 'Nicotine patches used in combination with e-cigarettes (with and without nicotine', 'telephone-delivered behavioural support', 'nicotine replacement therapy', 'nicotine patches (patches only group, n=125), patches plus a nicotine e-cigarette (patches plus nicotine e-cigarette group, n=500), or patches plus a nicotine-free e-cigarette (patches plus nicotine-free e-cigarette']","['intention to treat, with sensitivity analysis by per protocol, treatment adherence, varying CO cutoffs, and complete case analysis', 'CO-verified continuous abstinence', '18 serious adverse events', 'smoking cessation', 'death occurred (accidental drug overdose) and one life-threatening serious adverse event (heart attack', 'serious adverse events', 'exhaled carbon monoxide (CO)-verified continuous smoking abstinence 6 months']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C3849993', 'cui_str': 'Electronic Cigarettes'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0439536', 'cui_str': 'Medium (qualifier value)'}, {'cui': 'C4319551', 'cui_str': 'One hundred and twenty-five'}, {'cui': 'C0445403', 'cui_str': 'Human patch'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}]","[{'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C3849993', 'cui_str': 'Electronic Cigarettes'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0358855', 'cui_str': 'Nicotine Transdermal Patch'}, {'cui': 'C0445403', 'cui_str': 'Human patch'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0439268', 'cui_str': 'microgram/mL'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C1278444', 'cui_str': 'Nicotine replacement therapy'}]","[{'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C4505265', 'cui_str': 'Treatment Adherence'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0520803', 'cui_str': 'Accidental drug overdose (disorder)'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0231800', 'cui_str': 'Exhalation'}, {'cui': 'C0007018', 'cui_str': 'Carbon Monoxide'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]",125.0,0.0725699,18 serious adverse events occurred in 16 people in the patches plus nicotine e-cigarette group compared with 27 events in 22 people in the patches plus nicotine-free e-cigarette group and four events in three people in the patches only group.,"[{'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Walker', 'Affiliation': 'National Institute for Health Innovation, School of Population Health, The University of Auckland, Auckland, New Zealand. Electronic address: n.walker@auckland.ac.nz.'}, {'ForeName': 'Varsha', 'Initials': 'V', 'LastName': 'Parag', 'Affiliation': 'National Institute for Health Innovation, School of Population Health, The University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Marjolein', 'Initials': 'M', 'LastName': 'Verbiest', 'Affiliation': 'Tranzo, Tilburg School of Social and Behavioral Sciences, Tilburg University, Tilburg, The Netherlands.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Laking', 'Affiliation': 'Department of Oncology, School of Medical Sciences, The University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Murray', 'Initials': 'M', 'LastName': 'Laugesen', 'Affiliation': 'Department of Psychology, University of Canterbury, Christchurch, New Zealand.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Bullen', 'Affiliation': 'National Institute for Health Innovation, School of Population Health, The University of Auckland, Auckland, New Zealand.'}]",The Lancet. Respiratory medicine,['10.1016/S2213-2600(19)30269-3'] 1484,31502272,The Effect of Glutamine Supplementation on Microbial Invasion in Surgical Infants Requiring Parenteral Nutrition: Results of a Randomized Controlled Trial.,"BACKGROUND To determine whether parenteral plus enteral glutamine supplementation influences microbial invasion in surgical infants who require parenteral nutrition (PN). METHODS An prospective double-blind randomized controlled trial studying surgical infants receiving PN for at least 5 days for congenital or acquired intestinal anomalies (2009-2012) was used. Infants were randomized to receive either glutamine supplementation (parenteral plus enteral; total 400 mg/kg/d) or isonitrogenous control. The primary end point was microbial invasion evaluated after 5 days of supplementation and defined as: (i) positive conventional blood culture, (ii) evidence of microbial DNA in blood (polymerase chain reaction), (iii) plasma endotoxin level ≥50 pg/mL, or (iv) plasma level of lipopolysaccharide binding protein ≥50 ng/mL. Data are given as median (range) and compared by logistic regression. RESULTS Sixty infants were randomized and reached the primary end point. Twenty-five patients had intestinal obstruction, 19 had abdominal wall defects, and 13 had necrotizing enterocolitis. Thirty-six infants showed evidence of microbial invasion during the study, and 17 of these were not detected by conventional blood culture. There was no significant difference between the 2 groups in the primary outcome; evidence of microbial invasion after 5 days was found in 9/31 (control group) and 8/29 (glutamine group) (odds ratio 0.83 [0.24-2.86; P = 0.77]). CONCLUSION More than half of surgical infants requiring PN showed evidence of microbial invasion. Approximately half of this was not detectable by conventional blood cultures. Parenteral plus enteral glutamine supplementation had no effect on incidence of microbial invasion.",2020,"There was no significant difference between the 2 groups in the primary outcome; evidence of microbial invasion after 5 days was found in 9/31 (control group) and 8/29 (glutamine group) (odds ratio 0.83 [0.24-2.86; P = 0.77]). ","['Twenty-five patients had intestinal obstruction, 19 had abdominal wall defects, and 13 had necrotizing enterocolitis', 'Surgical Infants Requiring Parenteral Nutrition', 'Sixty infants', 'surgical infants who require parenteral nutrition (PN', 'surgical infants receiving PN for at least 5\xa0days for congenital or acquired intestinal anomalies (2009-2012']","['glutamine supplementation (parenteral plus enteral; total 400\xa0mg/kg/d) or isonitrogenous control', 'parenteral plus enteral glutamine supplementation', 'Parenteral plus enteral glutamine supplementation', 'Glutamine Supplementation']","['incidence of microbial invasion', 'Microbial Invasion', 'microbial invasion evaluated after 5\xa0days of supplementation and defined as: (i) positive conventional blood culture, (ii) evidence of microbial DNA in blood (polymerase chain reaction), (iii) plasma endotoxin level ≥50 pg/mL, or (iv) plasma level of lipopolysaccharide binding protein', 'microbial invasion']","[{'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0021843', 'cui_str': 'Intestinal Obstruction'}, {'cui': 'C0836916', 'cui_str': 'Abdominal Wall'}, {'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C0520459', 'cui_str': 'Necrotizing Enterocolitis'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0030547', 'cui_str': 'Parenteral Nutrition'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C1744681', 'cui_str': 'Congenital (qualifier value)'}, {'cui': 'C0439661', 'cui_str': 'Acquired (qualifier value)'}, {'cui': 'C0021853', 'cui_str': 'Intestines'}, {'cui': 'C0000769', 'cui_str': 'anomalies'}]","[{'cui': 'C0017797', 'cui_str': 'Glutamine'}, {'cui': 'C4522267', 'cui_str': 'Parenteral (intended site)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1304890', 'cui_str': 'Enteral (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0200949', 'cui_str': 'Blood Culture Test'}, {'cui': 'C0332120', 'cui_str': 'Evidence of (contextual qualifier) (qualifier value)'}, {'cui': 'C1291185', 'cui_str': 'Microbial DNA'}, {'cui': 'C0005768'}, {'cui': 'C0032520', 'cui_str': 'PCR'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0014264', 'cui_str': 'Endotoxins'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0439297', 'cui_str': 'pg/mL'}, {'cui': 'C0065054', 'cui_str': 'LPS-binding protein'}]",60.0,0.613814,"There was no significant difference between the 2 groups in the primary outcome; evidence of microbial invasion after 5 days was found in 9/31 (control group) and 8/29 (glutamine group) (odds ratio 0.83 [0.24-2.86; P = 0.77]). ","[{'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Bishay', 'Affiliation': 'University College of London Great Ormond Street Institute of Child Health, London, United Kingdom.'}, {'ForeName': 'Venetia', 'Initials': 'V', 'LastName': 'Simchowitz', 'Affiliation': 'University College of London Great Ormond Street Institute of Child Health, London, United Kingdom.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Harris', 'Affiliation': 'University College of London Great Ormond Street Institute of Child Health, London, United Kingdom.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Macdonald', 'Affiliation': 'University College of London Great Ormond Street Institute of Child Health, London, United Kingdom.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'De Coppi', 'Affiliation': 'University College of London Great Ormond Street Institute of Child Health, London, United Kingdom.'}, {'ForeName': 'Nigel', 'Initials': 'N', 'LastName': 'Klein', 'Affiliation': 'University College of London Great Ormond Street Institute of Child Health, London, United Kingdom.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Eaton', 'Affiliation': 'University College of London Great Ormond Street Institute of Child Health, London, United Kingdom.'}, {'ForeName': 'Agostino', 'Initials': 'A', 'LastName': 'Pierro', 'Affiliation': 'University College of London Great Ormond Street Institute of Child Health, London, United Kingdom.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': 'University College of London Great Ormond Street Institute of Child Health, London, United Kingdom.'}]",JPEN. Journal of parenteral and enteral nutrition,['10.1002/jpen.1700'] 1485,31393676,Three-dimensional laparoscopic vision improves forceps motion more in the depth direction than in the horizontal direction: An analysis of data from prospective randomized controlled trials.,"INTRODUCTION Three-dimensional (3D) laparoscopic vision can improve depth perception. However, it is a question whether 3D vision can improve motion in the depth direction. The aim of this study was to compare the impact of 3D vision on forceps motion in the depth and horizontal directions. METHODS All data were obtained from our previous two studies, where, in total, 40 novices and 20 moderately experienced surgeons participated. A simple phantom task was performed in a training box. The participants were randomly assigned to two groups. Specifically, one group performed the task five times initially under a two-dimensional (2D) system, and the other group started under a 3D system. Both groups then performed the same task five times under the alternative system. Performances were recorded by an optical position tracker. We separately evaluated forceps motion in the x-, y-, and z-axis directions. RESULTS Compared with the findings for 2D vision, the forceps path lengths were significantly decreased among novices and moderately experienced surgeons in almost all tasks under 3D vision. In a comparison of the path length ratio (3D/2D) in each direction, larger reduction was observed for the depth direction among novices, whereas no significant directional difference was noted among moderately experienced surgeons. CONCLUSIONS For novices, 3D laparoscopic vision improves depth perception and may give shorter forceps movement in the depth direction even for simple tasks.",2020,"Compared with the findings for 2D vision, the forceps path lengths were significantly decreased among novices and moderately experienced surgeons in almost all tasks under 3D vision.","['All data were obtained from our previous two studies, where, in total, 40 novices and 20 moderately experienced surgeons participated']",['horizontal direction'],"['forceps path lengths', 'depth perception']","[{'cui': 'C1301820', 'cui_str': 'Obtained (attribute)'}, {'cui': 'C0205448', 'cui_str': 'Two'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0582175', 'cui_str': 'Surgeon (occupation)'}]","[{'cui': 'C0205126', 'cui_str': 'Horizontal (qualifier value)'}, {'cui': 'C0439755', 'cui_str': 'Directions (qualifier value)'}]","[{'cui': 'C0016533', 'cui_str': 'Forceps'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0011586', 'cui_str': 'Stereopsis'}]",,0.049918,"Compared with the findings for 2D vision, the forceps path lengths were significantly decreased among novices and moderately experienced surgeons in almost all tasks under 3D vision.","[{'ForeName': 'Yuta', 'Initials': 'Y', 'LastName': 'Yamazaki', 'Affiliation': 'Division of Gastrointestinal Surgery, Department of Surgery, Kobe University Graduate School of Medicine, Kobe, Japan.'}, {'ForeName': 'Shingo', 'Initials': 'S', 'LastName': 'Kanaji', 'Affiliation': 'Division of Gastrointestinal Surgery, Department of Surgery, Kobe University Graduate School of Medicine, Kobe, Japan.'}, {'ForeName': 'Hitoshi', 'Initials': 'H', 'LastName': 'Harada', 'Affiliation': 'Division of Gastrointestinal Surgery, Department of Surgery, Kobe University Graduate School of Medicine, Kobe, Japan.'}, {'ForeName': 'Masayasu', 'Initials': 'M', 'LastName': 'Nishi', 'Affiliation': 'Division of Gastrointestinal Surgery, Department of Surgery, Kobe University Graduate School of Medicine, Kobe, Japan.'}, {'ForeName': 'Gosuke', 'Initials': 'G', 'LastName': 'Takiguchi', 'Affiliation': 'Division of Gastrointestinal Surgery, Department of Surgery, Kobe University Graduate School of Medicine, Kobe, Japan.'}, {'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Urakawa', 'Affiliation': 'Division of Gastrointestinal Surgery, Department of Surgery, Kobe University Graduate School of Medicine, Kobe, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Hasegawa', 'Affiliation': 'Division of Gastrointestinal Surgery, Department of Surgery, Kobe University Graduate School of Medicine, Kobe, Japan.'}, {'ForeName': 'Masashi', 'Initials': 'M', 'LastName': 'Yamamoto', 'Affiliation': 'Division of Gastrointestinal Surgery, Department of Surgery, Kobe University Graduate School of Medicine, Kobe, Japan.'}, {'ForeName': 'Yoshiko', 'Initials': 'Y', 'LastName': 'Matsuda', 'Affiliation': 'Division of Gastrointestinal Surgery, Department of Surgery, Kobe University Graduate School of Medicine, Kobe, Japan.'}, {'ForeName': 'Kimihiro', 'Initials': 'K', 'LastName': 'Yamashita', 'Affiliation': 'Division of Gastrointestinal Surgery, Department of Surgery, Kobe University Graduate School of Medicine, Kobe, Japan.'}, {'ForeName': 'Taro', 'Initials': 'T', 'LastName': 'Oshikiri', 'Affiliation': 'Division of Gastrointestinal Surgery, Department of Surgery, Kobe University Graduate School of Medicine, Kobe, Japan.'}, {'ForeName': 'Takeru', 'Initials': 'T', 'LastName': 'Matsuda', 'Affiliation': 'Division of Gastrointestinal Surgery, Department of Surgery, Kobe University Graduate School of Medicine, Kobe, Japan.'}, {'ForeName': 'Tetsu', 'Initials': 'T', 'LastName': 'Nakamura', 'Affiliation': 'Division of Gastrointestinal Surgery, Department of Surgery, Kobe University Graduate School of Medicine, Kobe, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Suzuki', 'Affiliation': 'Division of Gastrointestinal Surgery, Department of Surgery, Kobe University Graduate School of Medicine, Kobe, Japan.'}, {'ForeName': 'Yoshihiro', 'Initials': 'Y', 'LastName': 'Kakeji', 'Affiliation': 'Division of Gastrointestinal Surgery, Department of Surgery, Kobe University Graduate School of Medicine, Kobe, Japan.'}]",Asian journal of endoscopic surgery,['10.1111/ases.12745'] 1486,31937513,Safety and tolerability of adjunctive brivaracetam in epilepsy: In-depth pooled analysis.,"OBJECTIVE The objective of this analysis was to provide a comprehensive analysis of safety data for adjunctive brivaracetam (BRV), an antiepileptic drug (AED) of the racetam class, for treatment of focal seizures in patients with epilepsy. METHODS Data were pooled from two phase II, placebo-controlled, double-blind, dose-ranging trials (N01114 [ClinicalTrials.gov: NCT00175929], N01193 [NCT00175825]) and three phase III, placebo-controlled, double-blind, 12-week trials (N01252 [NCT00490035], N01253 [NCT00464269], and N01358 [NCT01261325]) in patients aged ≥16 years with focal seizures, as well as a phase III, placebo-controlled, double-blind, 16-week trial in patients aged ≥16 years with focal or generalized epilepsy (N01254 [NCT00504881]). Data are presented for the approved therapeutic dose range of 50-200 mg/day. Data for BRV administered intravenously (25-150 mg doses) were pooled separately from one phase III trial (N01258 NCT01405508]) and two clinical pharmacology trials (N01256 [Part B] [UCB Pharma, data on file]; EP0007 [NCT01796899]). Adverse events (AEs) of interest were summarized in relevant categories. RESULTS The safety pool comprised 1957 patients: 1271 receiving adjunctive BRV and 686 receiving placebo. Overall, the incidence of treatment-emergent adverse events (TEAEs) was 66.9% with BRV versus 62.8% with placebo. The most frequently reported TEAEs with BRV (≥5% of patients) versus placebo were somnolence (13.3% vs. 7.9%), headache (10.5% vs. 11.5%), dizziness (10.0% vs. 7.0%), and fatigue (8.2% vs. 4.2%). Incidence of psychiatric disorder-related TEAEs was 11.3% with BRV versus 8.2% with placebo. Behavioral disorder-related TEAE incidence was low (4.0% with BRV vs. 2.5% with placebo). Irritability was reported in 2.7% of BRV-treated patients vs. 1.5% of patients receiving placebo; anger, aggression, and agitation were each reported by ≤1% of patients receiving BRV. Treatment-emergent adverse events potentially associated with psychosis were psychotic disorder (three patients on BRV vs. two patients on placebo), auditory hallucination, illusion, visual hallucination (one patient each on BRV), epileptic psychosis, and hallucination (one patient each on placebo). No additional safety concerns were identified in patients with intravenous (IV) BRV administration (n = 104). CONCLUSIONS These safety data for adjunctive BRV support its acceptable safety and tolerability profile.",2020,Behavioral disorder-related TEAE incidence was low (4.0% with BRV vs. 2.5% with placebo).,"['patients with epilepsy', '1957 patients: 1271 receiving adjunctive BRV and 686 receiving', 'epilepsy', 'patients aged ≥16\u202fyears with focal seizures, as well as a phase III, placebo-controlled, double-blind, 16-week trial in patients aged ≥16\u202fyears with focal or generalized epilepsy (N01254 [NCT00504881']","['placebo', 'adjunctive brivaracetam', 'adjunctive brivaracetam (BRV']","['dizziness', 'Irritability', 'somnolence', 'Safety and tolerability', 'headache', 'Behavioral disorder-related TEAE incidence', 'incidence of treatment-emergent adverse events (TEAEs', 'auditory hallucination, illusion, visual hallucination (one patient each on BRV), epileptic psychosis, and hallucination', 'aggression, and agitation', 'Incidence of psychiatric disorder-related TEAEs', 'fatigue']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0014544', 'cui_str': 'Seizure Disorder'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0751495', 'cui_str': 'Seizures, Focal'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0205234', 'cui_str': 'Focal (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1699861', 'cui_str': 'Brivaracetam'}]","[{'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0022107', 'cui_str': 'Irritable Mood'}, {'cui': 'C2830004', 'cui_str': 'Somnolence'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0004930', 'cui_str': 'Behavior Disorders'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0233762', 'cui_str': 'Hallucinations, Auditory'}, {'cui': 'C0020903', 'cui_str': 'Illusions'}, {'cui': 'C0233763', 'cui_str': 'Hallucinations, Visual'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0338658', 'cui_str': 'Epileptic psychosis (disorder)'}, {'cui': 'C0018524', 'cui_str': 'Hallucinations'}, {'cui': 'C0001807', 'cui_str': 'Aggression'}, {'cui': 'C0085631', 'cui_str': 'Feeling agitated (finding)'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder (disorder)'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}]",1957.0,0.423204,Behavioral disorder-related TEAE incidence was low (4.0% with BRV vs. 2.5% with placebo).,"[{'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Brandt', 'Affiliation': 'Bethel Epilepsy Centre, Mara Hospital, Maraweg 21, 33617 Bielefeld, Germany. Electronic address: Christian.brandt@mara.de.'}, {'ForeName': 'Pavel', 'Initials': 'P', 'LastName': 'Klein', 'Affiliation': 'Mid-Atlantic Epilepsy and Sleep Center, Champlain Building, 6410 Rockledge Drive #610, Bethesda, MD 20817, USA. Electronic address: kleinp@epilepsydc.com.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Badalamenti', 'Affiliation': 'UCB Pharma, 8010 Arco Corporate Drive, Raleigh, NC 27617, USA. Electronic address: vcbadalamenti@aol.com.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Gasalla', 'Affiliation': 'UCB Pharma, 8010 Arco Corporate Drive, Raleigh, NC 27617, USA. Electronic address: Teresa.Gasalla@ucb.com.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Whitesides', 'Affiliation': 'UCB Pharma, 8010 Arco Corporate Drive, Raleigh, NC 27617, USA. Electronic address: John.Whitesides@ucb.com.'}]",Epilepsy & behavior : E&B,['10.1016/j.yebeh.2019.106864'] 1487,31504526,Immunogenicity of High Dose Influenza Vaccine for Patients with Inflammatory Bowel Disease on Anti-TNF Monotherapy: A Randomized Clinical Trial.,"BACKGROUND Patients with inflammatory bowel disease (IBD) on anti-tumor necrosis factor alpha (TNF) agents may have lower immune response to the influenza vaccine. We aimed to evaluate the immunogenicity of the high dose (HD) vs standard dose (SD) influenza vaccine in patients with IBD on anti-TNF monotherapy. METHODS We performed a randomized clinical trial at a single academic center evaluating the immunogenicity of the HD vs SD influenza vaccine in patients with IBD on anti-TNF monotherapy. Influenza antibody concentration was measured at immunization, at 2 to 4 weeks postimmunization, and at 6 months. RESULTS Sixty-nine patients with IBD were recruited into the study, 40 on anti-TNF monotherapy, and 19 on vedolizumab, along with 20 healthy controls (HC). Patients with IBD receiving the HD influenza vaccine had significantly higher H3N2 postimmunization antibodies compared with those who received the SD influenza vaccine (160 [interquartile range 80 to 320] vs 80 [interquartile range 40 to 160]; P = 0.003). The H1N1 postimmunization levels were not significantly higher in the HD influenza vaccine (320 [interquartile range 150 to 320] vs 160 [interquartile range 80 to 320]; P = 0.18). Patients with IBD receiving the HD influenza vaccine and those on vedolizumab who received SD had equivalent antibody concentrations to HC (H1N1 P = 0.85; H3N2 P = 0.23; B/Victoria P = 0.20 and H1N1 P = 0.46; H3N2 P = 0.21; B/Victoria P = 1.00, respectively). CONCLUSIONS Patients with IBD on anti-TNF monotherapy receiving the HD influenza vaccine had significantly higher postimmunization antibody levels compared with SD vaccine. Clinicaltrials.gov (#NCT02461758).",2020,Patients with IBD receiving the HD influenza vaccine had significantly higher H3N2 postimmunization antibodies compared with those who received the SD influenza vaccine (160 [interquartile range 80 to 320] vs 80 [interquartile range 40 to 160]; P = 0.003).,"['Patients with IBD receiving the', 'patients with IBD on anti-TNF monotherapy', 'Patients with Inflammatory Bowel Disease on Anti-TNF Monotherapy', 'Sixty-nine patients with IBD were recruited into the study, 40 on anti-TNF monotherapy, and 19 on vedolizumab, along with 20 healthy controls (HC', 'Patients with inflammatory bowel disease (IBD']","['SD influenza vaccine', 'HD influenza vaccine', 'High Dose Influenza Vaccine', 'high dose (HD) vs standard dose (SD) influenza vaccine', 'HD vs SD influenza vaccine']","['Influenza antibody concentration', 'H1N1 postimmunization levels', 'H3N2 postimmunization antibodies', 'postimmunization antibody levels', 'Immunogenicity']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0021390', 'cui_str': 'Inflammatory Bowel Diseases'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0450388', 'cui_str': '69 (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C2742797', 'cui_str': 'vedolizumab'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0021403', 'cui_str': 'Influenza Vaccines'}, {'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}]","[{'cui': 'C0236493', 'cui_str': 'Influenza antibody (substance)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0580264', 'cui_str': 'H1N1'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0580267', 'cui_str': 'H3N2'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}]",69.0,0.0913508,Patients with IBD receiving the HD influenza vaccine had significantly higher H3N2 postimmunization antibodies compared with those who received the SD influenza vaccine (160 [interquartile range 80 to 320] vs 80 [interquartile range 40 to 160]; P = 0.003).,"[{'ForeName': 'Freddy', 'Initials': 'F', 'LastName': 'Caldera', 'Affiliation': 'Department of Medicine, Division of Gastroenterology and Hepatology, University of Wisconsin-Madison, School of Medicine & Public Health, Madison, WI, USA.'}, {'ForeName': 'Luke', 'Initials': 'L', 'LastName': 'Hillman', 'Affiliation': 'Department of Medicine, Division of Gastroenterology and Hepatology, University of Wisconsin-Madison, School of Medicine & Public Health, Madison, WI, USA.'}, {'ForeName': 'Sumona', 'Initials': 'S', 'LastName': 'Saha', 'Affiliation': 'Department of Medicine, Division of Gastroenterology and Hepatology, University of Wisconsin-Madison, School of Medicine & Public Health, Madison, WI, USA.'}, {'ForeName': 'Arnold', 'Initials': 'A', 'LastName': 'Wald', 'Affiliation': 'Department of Medicine, Division of Gastroenterology and Hepatology, University of Wisconsin-Madison, School of Medicine & Public Health, Madison, WI, USA.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Grimes', 'Affiliation': 'Department of Medicine, Division of Gastroenterology and Hepatology, University of Wisconsin-Madison, School of Medicine & Public Health, Madison, WI, USA.'}, {'ForeName': 'Youqi', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'School of Pharmacy, University of Wisconsin-Madison, School of Medicine & Public Health, Madison, WI, USA.'}, {'ForeName': 'Abigail R', 'Initials': 'AR', 'LastName': 'Sharpe', 'Affiliation': 'School of Pharmacy, University of Wisconsin-Madison, School of Medicine & Public Health, Madison, WI, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Reichelderfer', 'Affiliation': 'Department of Medicine, Division of Gastroenterology and Hepatology, University of Wisconsin-Madison, School of Medicine & Public Health, Madison, WI, USA.'}, {'ForeName': 'Mary S', 'Initials': 'MS', 'LastName': 'Hayney', 'Affiliation': 'School of Pharmacy, University of Wisconsin-Madison, School of Medicine & Public Health, Madison, WI, USA.'}]",Inflammatory bowel diseases,['10.1093/ibd/izz164'] 1488,31503408,A texting-based blood pressure surveillance intervention.,"The authors examined whether using home BP measurements collected via a custom-built bi-directional-texting platform incorporated into patients' electronic medical records would lead to treatment calibration and improved BP management. Patients were randomized to either the intervention group and collected home measurements based on reminders and reported via bi-directional texting, or to the control group, with home BP measurement reporting via standard practice (eg, phone, electronic medical record portal) and instructed to return 7 morning and 7 evening BP measurements. Outcomes included number of BP measurements submitted, the number of medication changes, reduction in BP, and BP control. 72% of the intervention group submitted at least 14 readings, compared with 45% of the control group. BP control improved in both groups. However, the authors found no statistically significant difference in BP or the number of BP-medication changes at 1, 3, or 6 months compared with the control group.",2019,BP control improved in both groups.,[],"['intervention group and collected home measurements based on reminders and reported via bi-directional texting, or to the control group, with home BP measurement reporting via standard practice (eg, phone, electronic medical record portal) and instructed to return 7 morning and 7 evening BP measurements', 'A texting-based blood pressure surveillance intervention']","['number of BP measurements submitted, the number of medication changes, reduction in BP, and BP control', 'BP or the number of BP-medication changes', 'BP control']",[],"[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C2362543', 'cui_str': 'Electronic Medical Record'}, {'cui': 'C0205054', 'cui_str': 'Portal (qualifier value)'}, {'cui': 'C0332170', 'cui_str': 'Morning (qualifier value)'}, {'cui': 'C0587117', 'cui_str': 'Evening (qualifier value)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0733511', 'cui_str': 'Surveillance (regime/therapy)'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0580105', 'cui_str': 'Change of medication'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]",7.0,0.0398183,BP control improved in both groups.,"[{'ForeName': 'Roula S', 'Initials': 'RS', 'LastName': 'Zahr', 'Affiliation': 'Department of Internal Medicine, Oregon Health Sciences University, Portland, OR, USA.'}, {'ForeName': 'Chris A', 'Initials': 'CA', 'LastName': 'Anthony', 'Affiliation': 'Department of Orthopaedic Surgery, University of Iowa, Iowa City, IA, USA.'}, {'ForeName': 'Philip M', 'Initials': 'PM', 'LastName': 'Polgreen', 'Affiliation': 'Department of Internal Medicine, University of Iowa, Iowa City, IA, USA.'}, {'ForeName': 'Jacob E', 'Initials': 'JE', 'LastName': 'Simmering', 'Affiliation': 'Department of Internal Medicine, University of Iowa, Iowa City, IA, USA.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Goerdt', 'Affiliation': 'Department of Internal Medicine, University of Iowa, Iowa City, IA, USA.'}, {'ForeName': 'Angela B', 'Initials': 'AB', 'LastName': 'Hoth', 'Affiliation': 'Department of Internal Medicine, University of Iowa, Iowa City, IA, USA.'}, {'ForeName': 'Michelle L', 'Initials': 'ML', 'LastName': 'Miller', 'Affiliation': 'Department of Internal Medicine, University of Iowa, Iowa City, IA, USA.'}, {'ForeName': 'Manish', 'Initials': 'M', 'LastName': 'Suneja', 'Affiliation': 'Department of Internal Medicine, University of Iowa, Iowa City, IA, USA.'}, {'ForeName': 'Alberto M', 'Initials': 'AM', 'LastName': 'Segre', 'Affiliation': 'Department of Computer Science, University of Iowa, Iowa City, IA, USA.'}, {'ForeName': 'Barry L', 'Initials': 'BL', 'LastName': 'Carter', 'Affiliation': 'Department of Pharmacy Practice and Science, University of Iowa, Iowa City, IA, USA.'}, {'ForeName': 'Joseph E', 'Initials': 'JE', 'LastName': 'Cavanaugh', 'Affiliation': 'Department of Biostatistics, University of Iowa, Iowa City, IA, USA.'}, {'ForeName': 'Linnea A', 'Initials': 'LA', 'LastName': 'Polgreen', 'Affiliation': 'Department of Pharmacy Practice and Science, University of Iowa, Iowa City, IA, USA.'}]","Journal of clinical hypertension (Greenwich, Conn.)",['10.1111/jch.13674'] 1489,31490536,Assessment of the End Point Adjudication Process on the Results of the Platelet-Oriented Inhibition in New TIA and Minor Ischemic Stroke (POINT) Trial: A Secondary Analysis.,"Importance Debate continues about the value of event adjudication in clinical trials and whether independent centralized assessments improve reliability and validity of study results in masked randomized trials compared with local, investigator-assessed end points. Objective To assess the results of the adjudicated end point process in the Platelet-Oriented Inhibition in New TIA and Minor Ischemic Stroke (POINT) trial by comparing end points assessed by local site investigators with centrally adjudicated end points. Design, Setting, and Participants This is an ad hoc secondary analysis of a randomized, double-blind clinical trial comparing safety and effectiveness of clopidogrel bisulphate plus aspirin vs placebo plus aspirin. Patients received either 600 mg of clopidogrel bisulphate on day 1, then 75 mg per day through day 90 plus 50 to 325 mg of aspirin per day, or the same range of dosages of placebo plus aspirin. Investigators reported all potential end points; independent masked adjudicators were randomly assigned to review using definitions specified in the study protocol. This was a multicenter study; 269 international sites in 10 countries enrolled from May 28, 2010, to December 19, 2017. The study enrolled 4881 patients 18 years or older with transient ischemic attack or minor acute ischemic stroke within 12 hours of symptom onset and followed for 90 days from randomization; last follow-up was completed in March 2018. Main Outcomes and Measures Independent adjudicators external to the study and masked to study treatment assignment adjudicated 467 primary and secondary effectiveness outcomes and major and minor bleeding events, including the primary composite end point, which was the risk of a composite of major ischemic events at 90 days, defined as ischemic stroke, myocardial infarction, or death from an ischemic vascular event. The primary safety end point was major hemorrhage. All components of the primary and safety outcomes were adjudicated. Results In this secondary analysis of an international randomized clinical trial, a total of 269 sites worldwide randomized 4881 patients (median age, 65.0 years; interquartile range, 55-74 years); 55.0% were male. The primary results have been published previously. The hazard ratios for clopidogrel plus aspirin vs placebo plus aspirin for the primary composite end point were 0.75 (95% CI, 0.59-0.95) for adjudicator-assessed events and 0.76 (95% CI, 0.60-0.95) for investigator-assessed events. Agreement between adjudicator and investigator assessments was 90.7%. The hazard ratios for clopidogrel plus aspirin vs placebo plus aspirin for the primary safety end point were 2.32 (95% CI, 1.10-4.87) for adjudicator-assessed events and 2.58 (95% CI, 1.19-5.58) for investigator-assessed events, with an agreement rate of 77.5%. Conclusions and Relevance Independent end point adjudication did not substantially alter estimates of the primary treatment effectiveness in the POINT trial. Trial Registration ClinicalTrials.gov identifier: NCT00991029.",2019,"The hazard ratios for clopidogrel plus aspirin vs placebo plus aspirin for the primary composite end point were 0.75 (95% CI, 0.59-0.95) for adjudicator-assessed events and 0.76","['4881 patients 18 years or older with transient ischemic attack or minor acute ischemic stroke within 12 hours of symptom onset and followed for 90 days from randomization; last follow-up was completed in March 2018', 'multicenter study; 269 international sites in 10 countries enrolled from May 28, 2010, to December 19, 2017', '269 sites worldwide randomized 4881 patients (median age, 65.0 years; interquartile range, 55-74 years); 55.0% were male']","['clopidogrel bisulphate', 'clopidogrel bisulphate plus aspirin vs placebo plus aspirin', 'placebo plus aspirin', 'aspirin']","['secondary effectiveness outcomes and major and minor bleeding events, including the primary composite end point, which was the risk of a composite of major ischemic events at 90 days, defined as ischemic stroke, myocardial infarction, or death from an ischemic vascular event', 'Platelet-Oriented Inhibition in New TIA and Minor Ischemic Stroke (POINT', 'major hemorrhage', 'hazard ratios']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0007787', 'cui_str': 'Brain TIA'}, {'cui': 'C0026193', 'cui_str': 'Minors'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C1292430', 'cui_str': '12 hours'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C1096776', 'cui_str': 'Multicenter Study'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0086582', 'cui_str': 'Males'}]","[{'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0026193', 'cui_str': 'Minors'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0475224', 'cui_str': 'Ischemic (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0005821', 'cui_str': 'Platelets'}, {'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0007787', 'cui_str': 'Brain TIA'}, {'cui': 'C1869041', 'cui_str': 'Haemorrhages (SMQ)'}]",467.0,0.646926,"The hazard ratios for clopidogrel plus aspirin vs placebo plus aspirin for the primary composite end point were 0.75 (95% CI, 0.59-0.95) for adjudicator-assessed events and 0.76","[{'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Farrant', 'Affiliation': 'University of California, San Francisco.'}, {'ForeName': 'J Donald', 'Initials': 'JD', 'LastName': 'Easton', 'Affiliation': 'University of California, San Francisco.'}, {'ForeName': 'Eric E', 'Initials': 'EE', 'LastName': 'Adelman', 'Affiliation': 'Department of Neurology, University of Wisconsin School of Medicine and Public Health, Madison.'}, {'ForeName': 'Brett L', 'Initials': 'BL', 'LastName': 'Cucchiara', 'Affiliation': 'University of Pennsylvania, Philadelphia.'}, {'ForeName': 'William G', 'Initials': 'WG', 'LastName': 'Barsan', 'Affiliation': 'Department of Emergency Medicine, University of Michigan, Ann Arbor.'}, {'ForeName': 'Holly J', 'Initials': 'HJ', 'LastName': 'Tillman', 'Affiliation': 'Data Coordination Unit, Department of Public Health Sciences, Medical University of South Carolina, Charleston.'}, {'ForeName': 'Jordan J', 'Initials': 'JJ', 'LastName': 'Elm', 'Affiliation': 'Data Coordination Unit, Department of Public Health Sciences, Medical University of South Carolina, Charleston.'}, {'ForeName': 'Anthony S', 'Initials': 'AS', 'LastName': 'Kim', 'Affiliation': 'University of California, San Francisco.'}, {'ForeName': 'Anne S', 'Initials': 'AS', 'LastName': 'Lindblad', 'Affiliation': 'The Emmes Corporation, Rockville, Maryland.'}, {'ForeName': 'Yuko Y', 'Initials': 'YY', 'LastName': 'Palesch', 'Affiliation': 'Data Coordination Unit, Department of Public Health Sciences, Medical University of South Carolina, Charleston.'}, {'ForeName': 'Wenle', 'Initials': 'W', 'LastName': 'Zhao', 'Affiliation': 'Data Coordination Unit, Department of Public Health Sciences, Medical University of South Carolina, Charleston.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Pauls', 'Affiliation': 'Data Coordination Unit, Department of Public Health Sciences, Medical University of South Carolina, Charleston.'}, {'ForeName': 'Kyle B', 'Initials': 'KB', 'LastName': 'Walsh', 'Affiliation': 'Department of Emergency Medicine, University of Cincinnati, Cincinnati, Ohio.'}, {'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Martí-Fàbregas', 'Affiliation': 'Department of Neurology, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain.'}, {'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Bernstein', 'Affiliation': 'Department of Neurology, Feinberg School of Medicine, Northwestern University, Chicago, Illinois.'}, {'ForeName': 'S Claiborne', 'Initials': 'SC', 'LastName': 'Johnston', 'Affiliation': ""Dean's Office, Dell Medical School, The University of Texas at Austin.""}]",JAMA network open,['10.1001/jamanetworkopen.2019.10769'] 1490,32436796,Evaluation of various carbon dioxide laser settings on the time and number of laser beam passes required to make a full-thickness skin incision and amount of laser-induced tissue artifact.,"OBJECTIVE To evaluate the time and number of laser beam passes required to make full-thickness skin incisions and extent of laser-induced tissue artifacts following use of a CO 2 laser at various settings. SAMPLE 24 skin specimens from six 5-month-old porcine carcasses. PROCEDURES 4 full-thickness skin specimens were harvested from the flank regions of each carcass within 30 minutes after euthanasia and randomly assigned to 4 treatment groups. Three 5-cm-long incisions were made in each specimen with a CO 2 laser (beam diameter, 0.4 mm) set to deliver a continuous wave of energy alone (groups 1 and 2) or in superpulse mode (groups 3 and 4) at 10 (groups 1 and 3) or 20 (groups 2 and 4) W of power. The time and number of passes required to achieve a full-thickness incision were recorded, and extent of laser-induced tissue artifact (as determined by histologic evaluation) was compared among the 4 groups. RESULTS Mean time required to make a full-thickness skin incision for groups 2 and 4 (power, 20 W) was significantly less than that for groups 1 and 3 (power, 10 W). Mean number of passes was lowest for group 2 (continuous wave at 20 W). Extent of laser-induced tissue artifact was greatest for group 4 (superpulse mode at 20 W). CONCLUSIONS AND CLINICAL RELEVANCE Results provided preliminary information regarding use of CO 2 lasers to make skin incisions in veterinary patients. In vivo studies are necessary to evaluate the effect of various CO 2 laser settings on tissue healing and patient outcome.",2020,"Extent of laser-induced tissue artifact was greatest for group 4 (superpulse mode at 20 W). ","['SAMPLE\n\n\n24 skin specimens from six 5-month-old porcine carcasses', 'veterinary patients']",['various carbon dioxide laser settings'],"['Mean number of passes', 'tissue artifact', 'time and number of passes required to achieve a full-thickness incision', 'Mean time required to make a full-thickness skin incision']","[{'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0039005', 'cui_str': 'Suidae'}, {'cui': 'C0042614', 'cui_str': 'veterinary'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0392251', 'cui_str': 'Carbon dioxide laser device'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0085089', 'cui_str': 'Artifact'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439809', 'cui_str': 'Full thickness'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0191279', 'cui_str': 'Incision of skin'}]",,0.0146509,"Extent of laser-induced tissue artifact was greatest for group 4 (superpulse mode at 20 W). ","[{'ForeName': 'Lori M', 'Initials': 'LM', 'LastName': 'Agulian', 'Affiliation': ''}, {'ForeName': 'F A', 'Initials': 'FA', 'LastName': 'Mann', 'Affiliation': ''}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Middleton', 'Affiliation': ''}, {'ForeName': 'Dae Y', 'Initials': 'DY', 'LastName': 'Kim', 'Affiliation': ''}]",American journal of veterinary research,['10.2460/ajvr.81.6.514'] 1491,32071901,Age-Related Serum Thyroid-Stimulating Hormone Reference Range in Older Patients Treated with Levothyroxine: A Randomized Controlled Feasibility Trial (SORTED 1).,"Introduction Serum thyroid-stimulating hormone (TSH) increases with age but target TSH is similar in younger and older hypothyroid patients on treatment. It is unknown if quality of life (QoL), hypothyroid symptoms and cardiovascular risk factors change in older hypothyroid patients treated to an age-appropriate reference range. Objective To assess if a higher target serum TSH of 4.01-8.0 mU/L is feasible in, and acceptable to, older treated hypothyroid patients. Methods A single-blind (participant) randomised controlled feasibility trial involving 48 hypothyroid patients aged ≥80 years on established and stable levothyroxine (LT4) therapy with serum TSH levels within the standard reference range (0.4-4.0 mU/L) was conducted. Standard (0.4-4.0 mU/L) or higher (4.1-8.0 mU/L) TSH target (standard TSH [ST] or higher TSH [HT] groups) LT4 for 24 weeks was administered. The outcome measures evaluated were thyroid function tests, QoL, hypothyroid symptoms, cardiovascular risk factors and serum marker of bone resorption in participants that completed the trial ( n = 21/24 ST group, n = 19/24 HT group). Results At 24 weeks, in the ST and HT groups, respectively, median (interquartile range) serum TSH was 1.25 (0.76-1.72) and 5.50 (4.05-9.12) mU/L, mean (± SD) free thyroxine (FT4) was 19.4 ± 3.5 and 15.9 ± 2.4 pmol/L, and daily LT4 dose was 82.1 ± 26.4 and 59.2 ± 23.9 µg. There was no suggestion of adverse impact of a higher serum TSH in the HT group with regard to any of the outcomes assessed. Conclusions In hypothyroid patients aged ≥80 years on LT4 therapy for 24 weeks, there was no evidence that a higher target serum TSH was associated with an adverse impact on patient reported outcomes, cardiovascular risk factors or bone resorption marker over 24 weeks. Longer-term trials assessing morbidity and mortality outcomes and health-utility in this age group are feasible and should be performed.",2020,"There was no suggestion of adverse impact of a higher serum TSH in the HT group with regard to any of the outcomes assessed. ","['48 hypothyroid patients aged ≥80 years on established and stable levothyroxine (LT4) therapy with serum TSH levels within the standard reference range (0.4-4.0 mU/L) was conducted', 'older treated hypothyroid patients', 'older hypothyroid patients treated to an age-appropriate reference range', 'hypothyroid patients aged ≥80 years on']","['LT4 therapy', 'Introduction\n\n\nSerum thyroid-stimulating hormone (TSH', 'Levothyroxine']","['serum TSH', 'thyroid function tests, QoL, hypothyroid symptoms, cardiovascular risk factors and serum marker of bone resorption', 'cardiovascular risk factors or bone resorption marker', 'target serum TSH', 'median (interquartile range) serum TSH', 'morbidity and mortality outcomes and health-utility']","[{'cui': 'C0020676', 'cui_str': 'Hypothyroidism'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C1881373', 'cui_str': ""L-3,5,3',5'-Tetraiodothyronine""}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1277938', 'cui_str': 'Serum TSH measurement'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0086715', 'cui_str': 'Normal Range'}, {'cui': 'C4517457', 'cui_str': 'Zero point four'}, {'cui': 'C0439342', 'cui_str': 'uU/mL'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1293116', 'cui_str': 'Introduction'}, {'cui': 'C0857986', 'cui_str': 'Serum thyroid stimulating hormone'}, {'cui': 'C0202230', 'cui_str': 'Thyroid stimulating hormone measurement (procedure)'}, {'cui': 'C1881373', 'cui_str': ""L-3,5,3',5'-Tetraiodothyronine""}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0202230', 'cui_str': 'Thyroid stimulating hormone measurement (procedure)'}, {'cui': 'C0040130', 'cui_str': 'Thyroid Gland Function Tests'}, {'cui': 'C0020676', 'cui_str': 'Hypothyroidism'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0162491', 'cui_str': 'Serum Markers'}, {'cui': 'C0005974', 'cui_str': 'Osteoclastic Bone Loss'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",48.0,0.120906,"There was no suggestion of adverse impact of a higher serum TSH in the HT group with regard to any of the outcomes assessed. ","[{'ForeName': 'Salman', 'Initials': 'S', 'LastName': 'Razvi', 'Affiliation': 'Institute of Genetic Medicine, Newcastle University, Newcastle, United Kingdom.'}, {'ForeName': 'Vicky', 'Initials': 'V', 'LastName': 'Ryan', 'Affiliation': 'Institute of Health and Society, Newcastle University, Newcastle, United Kingdom.'}, {'ForeName': 'Lorna', 'Initials': 'L', 'LastName': 'Ingoe', 'Affiliation': 'Department of Endocrinology, Gateshead Health NHS Foundation Trust, Gateshead, United Kingdom.'}, {'ForeName': 'Simon H', 'Initials': 'SH', 'LastName': 'Pearce', 'Affiliation': 'Institute of Genetic Medicine, Newcastle University, Newcastle, United Kingdom.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Wilkes', 'Affiliation': 'School of Medicine, University of Sunderland, Sunderland, United Kingdom.'}]",European thyroid journal,['10.1159/000504047'] 1492,31508861,An Evidence-Based Model for Disseminating-Implementing Coordinated Anxiety Learning and Management in Department of Veterans Affairs' Community-Based Outpatient Clinics.,"PURPOSE To explore the feasibility and utility of using a workshop, and supervision-consultation plus external facilitation to disseminate and implement cognitive-behavioral therapy in Veterans Affairs (VA) community-based outpatient clinics (CBOCs). METHODS This study occurred in the context of a randomized controlled trial aimed at comparing 2 methods for implementing Coordinated Anxiety Learning Management (CALM) in VA CBOCs. A 3-phase (workshop, supervision-consultation, external facilitation) model was used to support 32 VA CBOC mental health providers in learning and adopting CALM in their clinical practice. Qualitative data describe training activities and the feasibility and utility of each training phase in addressing challenges to adopting CALM. FINDINGS All 3 phases of the model were feasible to use with our sample of CBOC mental health providers. Providers reported challenges learning CALM during the workshop and concerns about not having enough training post-workshop to use CALM in practice. Providers primarily utilized supervision-consultation to tailor CALM to their practice, including learning how to prioritize a target disorder, ""switch"" the focus of treatment to a different disorder when comorbidities were present, and modify CALM sessions to fit shorter treatment visits. Providers primarily utilized external facilitation to further tailor CALM to their practice through implementation (eg, concrete help) and support-oriented help. Key lessons for implementing CALM in CBOCs are presented and discussed. CONCLUSIONS Findings provide initial evidence for the feasibility and utility of using each component of a facilitation-enhanced training model to promote CBOC VA providers' implementation of a computer and manual version of CALM in their practice.",2020,"A 3-phase (workshop, supervision-consultation, external facilitation) model was used to support 32 VA CBOC mental health providers in learning and adopting CALM in their clinical practice.",['Veterans Affairs (VA) community-based outpatient clinics (CBOCs'],"['implementing Coordinated Anxiety Learning Management (CALM', 'workshop, and supervision-consultation plus external facilitation to disseminate and implement cognitive-behavioral therapy']",[],"[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0002424', 'cui_str': 'Outpatient Clinics'}]","[{'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0150157', 'cui_str': 'Calming'}, {'cui': 'C0242262', 'cui_str': 'Workshops'}, {'cui': 'C0038842', 'cui_str': 'Supervision'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0205101', 'cui_str': 'External (qualifier value)'}, {'cui': 'C0234112', 'cui_str': 'Facilitation, function (observable entity)'}, {'cui': 'C0205221', 'cui_str': 'Disseminated (qualifier value)'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}]",[],,0.0174379,"A 3-phase (workshop, supervision-consultation, external facilitation) model was used to support 32 VA CBOC mental health providers in learning and adopting CALM in their clinical practice.","[{'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Cucciare', 'Affiliation': 'Center for Mental Healthcare and Outcomes Research, Central Arkansas Veterans Affairs Healthcare System, North Little Rock, Arkansas.'}, {'ForeName': 'Kathy', 'Initials': 'K', 'LastName': 'Marchant', 'Affiliation': 'Center for Mental Healthcare and Outcomes Research, Central Arkansas Veterans Affairs Healthcare System, North Little Rock, Arkansas.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Lindsay', 'Affiliation': 'Houston Veterans Affairs Health Services Research and Development Service Center for Innovations in Quality, Effectiveness, and Safety, Michael E DeBakey Veterans Affairs Medical Center, Houston, Texas.'}, {'ForeName': 'Michelle G', 'Initials': 'MG', 'LastName': 'Craske', 'Affiliation': 'Department of Psychology, University of California-Los Angeles, Los Angeles, California.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Ecker', 'Affiliation': 'Houston Veterans Affairs Health Services Research and Development Service Center for Innovations in Quality, Effectiveness, and Safety, Michael E DeBakey Veterans Affairs Medical Center, Houston, Texas.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Day', 'Affiliation': 'Houston Veterans Affairs Health Services Research and Development Service Center for Innovations in Quality, Effectiveness, and Safety, Michael E DeBakey Veterans Affairs Medical Center, Houston, Texas.'}, {'ForeName': 'Julianna', 'Initials': 'J', 'LastName': 'Hogan', 'Affiliation': 'Houston Veterans Affairs Health Services Research and Development Service Center for Innovations in Quality, Effectiveness, and Safety, Michael E DeBakey Veterans Affairs Medical Center, Houston, Texas.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Henn', 'Affiliation': 'VA Texas Valley Coastal Bend Health Care System, Harlingen, Texas.'}, {'ForeName': 'Richard T', 'Initials': 'RT', 'LastName': 'LeBeau', 'Affiliation': 'Department of Psychology, University of California-Los Angeles, Los Angeles, California.'}, {'ForeName': 'Aline', 'Initials': 'A', 'LastName': 'Rabalais', 'Affiliation': 'VA North Texas Health Care System, Dallas, Texas.'}, {'ForeName': 'Raphael D', 'Initials': 'RD', 'LastName': 'Rose', 'Affiliation': 'Department of Psychology, University of California-Los Angeles, Los Angeles, California.'}, {'ForeName': 'Mason', 'Initials': 'M', 'LastName': 'Qualls', 'Affiliation': 'Harvard South Shore Psychiatry Residency Training Program, Brockton, Massachusetts.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Treanor', 'Affiliation': 'Department of Psychology, Anxiety and Depression Research Center, University of California-Los Angeles, Los Angeles, California.'}, {'ForeName': 'Traci H', 'Initials': 'TH', 'LastName': 'Abraham', 'Affiliation': 'Center for Mental Healthcare and Outcomes Research, Central Arkansas Veterans Affairs Healthcare System, North Little Rock, Arkansas.'}]",The Journal of rural health : official journal of the American Rural Health Association and the National Rural Health Care Association,['10.1111/jrh.12398'] 1493,30724634,Linguistic Sexism in Peer-Reviewed Research Influences Recall But Not Perceptions.,"The Publication Manual of the American Psychological Association (APA) prohibits bias in academic writing. One bias regarding gender is male firstness (i.e., the persistent placement of masculine terms before feminine ones). A recent content analysis found that a male-firstness bias exists in peer-reviewed social science journals. Using a sample of faculty members and graduate students ( n = 754), we sought to examine the potential effects of male firstness in academic writing. Participants were randomly assigned to read the results of a bogus research article that demonstrated female firstness or male firstness; we also manipulated the topic of the article to be neutral, feminine, or masculine. Participants then responded to measures assessing perceptions and recall. The order of gendered terms and results seemed to influence readers' recall of information but not their perceptions of the writing. Given these effects, researchers should strive to be conscious of male firstness when writing.",2020,The order of gendered terms and results seemed to influence readers' recall of information but not their perceptions of the writing.,['faculty members and graduate students (n =\xa0754'],[],[],"[{'cui': 'C0015535', 'cui_str': 'Faculty'}, {'cui': 'C0588053', 'cui_str': 'Graduate (person)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}]",[],[],,0.0327862,The order of gendered terms and results seemed to influence readers' recall of information but not their perceptions of the writing.,"[{'ForeName': 'Malachi', 'Initials': 'M', 'LastName': 'Willis', 'Affiliation': 'Department of Health, Human Performance, and Recreation, University of Arkansas.'}, {'ForeName': 'Kristen N', 'Initials': 'KN', 'LastName': 'Jozkowski', 'Affiliation': 'Department of Health, Human Performance, and Recreation, University of Arkansas.'}]",Journal of sex research,['10.1080/00224499.2019.1568378'] 1494,32436633,Five weeks of heat training increases haemoglobin mass in elite cyclists.,"NEW FINDINGS What is the central question of this study? Do haemoglobin mass and red blood cell volume increase in elite cyclists training in a hot environment compared to a control group training at normal temperature? What is the main finding and its importance? Five weeks of heat training increases haemoglobin mass in elite cyclists. There are small to intermediate effect sizes for exercise parameters favouring heat training. ABSTRACT In this study we tested the hypothesis that performing 1 h of regular light exercise in a heat chamber (HEAT; 37.8 ± 0.5°C; 65.4 ± 1.8% humidity) 5 times week -1 for a total of 5 weeks increases haemoglobin mass (Hb mass ) and exercise performance in elite cyclists ( V ̇ O 2 max  = 76.2 ± 7.6 ml min -1  kg -1 ). Twenty-three male volunteers were assigned to HEAT (n = 11) or CON (n = 12; 15.5 ± 0.1°C; 25.1 ± 0.0% humidity) training groups. Hb mass was determined before and after the intervention period in conjunction with an extensive exercise test protocol (conducted at 16-19°C). HEAT increased (P < 0.05) Hb mass by 42 g from 893 ± 78 to 935 ± 108 g whereas Hb mass remained unchanged (+6 g) in CON. Furthermore, statistical analysis revealed a time-group interaction (P < 0.05). The greater increase in Hb mass in HEAT, however, did not manifest in a greater increase in V ̇ O 2 max (225 ± 274 ml min -1 in HEAT and 161 ± 202 ml min -1 in CON). While HEAT reduced (P < 0.05) lactate levels during some of the submaximal exercise tests, there was no statistical difference between other performance parameters. There were, however, small to intermediate effect sizes favouring HEAT for lactate threshold power output (2.8 ± 3.9 vs. -0.4 ± 5.1% change, effect size (ES) = 0.34), gross economy in the fatigued state (0.19 ± 0.42 vs. -0.12 ± 0.49%-point change, ES = 0.52) and 15 min mean power (6.9 ± 8.4 vs. 3.4 ± 5.1% increase, ES = 0.22). This study demonstrates an increase in Hb mass and small to intermediate effect sizes on exercise variables in elite cyclists following a 5-week heat training intervention.",2020,HEAT increased (p < 0.05),"['202', '274', 'elite cyclists (V̇O 2max \xa0=\xa076.2\xa0±\xa07.6\xa0mL·min -1 ·kg -1 ', '23 male volunteers', 'elite cyclists following a five-week heat training intervention', 'g from 893\xa0±\xa078 to 935\xa0±\xa0108', 'elite cyclists']","['extensive exercise test protocol', 'HEAT', 'regular light exercise', 'heat training', 'CON']","['lactate levels', 'V̇O 2max (225\xa0±', 'hemoglobin mass (Hb mass ) and exercise performance', 'hemoglobin mass']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C4517530', 'cui_str': '108'}]","[{'cui': 'C0205231', 'cui_str': 'Extensive'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0428445', 'cui_str': 'D-lactate measurement'}, {'cui': 'C4517652', 'cui_str': '225'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",23.0,0.01331,HEAT increased (p < 0.05),"[{'ForeName': 'Bent R', 'Initials': 'BR', 'LastName': 'Rønnestad', 'Affiliation': 'Innland University of Applied Sciences, Lillehammer, Norway.'}, {'ForeName': 'Håvard', 'Initials': 'H', 'LastName': 'Hamarsland', 'Affiliation': 'Innland University of Applied Sciences, Lillehammer, Norway.'}, {'ForeName': 'Joar', 'Initials': 'J', 'LastName': 'Hansen', 'Affiliation': 'Innland University of Applied Sciences, Lillehammer, Norway.'}, {'ForeName': 'Espen', 'Initials': 'E', 'LastName': 'Holen', 'Affiliation': 'Innland University of Applied Sciences, Lillehammer, Norway.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Montero', 'Affiliation': 'Faculty of Kinesiology, Cumming School of Medicine, University of Calgary, Calgary, Canada.'}, {'ForeName': 'Jon Elling', 'Initials': 'JE', 'LastName': 'Whist', 'Affiliation': 'Innlandet Hospital Trust, Lillehammer, Norway.'}, {'ForeName': 'Carsten', 'Initials': 'C', 'LastName': 'Lundby', 'Affiliation': 'Innland University of Applied Sciences, Lillehammer, Norway.'}]",Experimental physiology,['10.1113/EP088544'] 1495,31894045,Clinical observation of minocycline hydrochloride ointment in the treatment of early peri-implantitis.,"To observe and analyze the therapeutic efficacy of minocycline hydrochloride ointment in the treatment of early peri-implantitis. A total of 180 patients with early peri-implantitis and treated at our hospital were enrolled. The patients were divided into control group and research group, with 90 patients in each group. Of those, patients in the research group were treated with minocycline hydrochloride ointment, while 10% of iodine was placed around the teeth in patients of the control group. The therapeutic efficacy was observed and compared between both groups. By comparing the plaque index of both groups after treatment, results showed that the improvement of the research group was obviously better than that of the control group (p<0.05). By comparing the probing depth and sulcus bleeding index, results showed that the situation of the research group was significantly superior than that of the control group (p<0.05). Application of minocycline hydrochloride ointment in the treatment of early peri-implantitis could significantly improve the therapeutic efficacy.",2019,"By comparing the probing depth and sulcus bleeding index, results showed that the situation of the research group was significantly superior than that of the control group (p<0.05).","['early peri-implantitis', '180 patients with early peri-implantitis and treated at our hospital were enrolled']","['iodine', 'minocycline hydrochloride ointment']","['plaque index', 'probing depth and sulcus bleeding index', 'therapeutic efficacy']","[{'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C2936258', 'cui_str': 'Periimplantitis'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1292734', 'cui_str': 'Treats'}]","[{'cui': 'C0021968', 'cui_str': 'molecular iodine'}, {'cui': 'C0026186', 'cui_str': 'Minocycline Hydrochloride'}, {'cui': 'C0028912', 'cui_str': 'Salves'}]","[{'cui': 'C0332461', 'cui_str': 'Plaque (morphologic abnormality)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C3179165', 'cui_str': 'Probe (methazole)'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]",180.0,0.0124959,"By comparing the probing depth and sulcus bleeding index, results showed that the situation of the research group was significantly superior than that of the control group (p<0.05).","[{'ForeName': 'Bao', 'Initials': 'B', 'LastName': 'Tian', 'Affiliation': ""Department of Stomatology, Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital, Chengdu, China.""}]",Pakistan journal of pharmaceutical sciences,[] 1496,31494047,The impact of chest computed tomography and chest radiography on clinical management of cystic fibrosis lung disease.,"BACKGROUND Recent standards of care mention chest radiography (CR) but not chest computed tomography (CT) in routine annual follow-up of children with cystic fibrosis (CF). To minimise radiation risk, CT or CR should only be performed if they impact clinical decision making. We investigated whether in addition to a wide range of commonly used clinical parameters, chest CT and/or CR in routine follow-up of CF patients influence clinical decisions. METHODS 36 web based clinical vignettes (i.e. case simulations) were designed using clinical data from patients aged 8-18 years, randomly selected from two CF centres in The Netherlands. In a randomized cross-over design, clinicians assessed eight vignettes and suggested therapeutic/diagnostic management on two occasions, with a ten-week interval. Radiological information (CT or CR) was included at only one of the two assessments, in random order. Any differences in management could be attributed to information from CT or CR, and were compared by McNemar analysis. RESULTS 44 European and Australian clinicians completed a total of 143 CT vignette pairs and 167 CR vignette pairs. CT was associated with a significant increase in antifungal treatment (Risk Ratio (RR) 2.8 (1.3-6.0, p = .02)), bronchoscopies (RR 1.6 (1.1-2.5, p = .04)), mycobacterial cultures (RR 1.3 (1.0-1.5, p = .02)), and 'need for hospitalization' (i.e. intravenous antibiotics and/or bronchoscopy) (RR 1.4 (1.0-1.9, p = .03)). CR led to a significant increase in inhaled antibiotics only (RR 1.3 (1.0-1.6, p = .04)). CONCLUSIONS CT but not CR, at routine biennial follow-up was associated with several changes in treatment and/or diagnostic testing, including the need for hospitalization.",2020,"CT was associated with a significant increase in antifungal treatment (Risk Ratio (RR) 2.8 (1.3-6.0, p = .02)), bronchoscopies (RR 1.6 (1.1-2.5, p = .04)), mycobacterial cultures (RR 1.3 (1.0-1.5, p = .02)), and 'need for hospitalization' (i.e. intravenous antibiotics and/or bronchoscopy) (RR 1.4 (1.0-1.9, p = .03)).","['44 European and Australian clinicians completed a total of 143 CT vignette pairs and 167 CR vignette pairs', 'children with cystic fibrosis (CF', 'cystic fibrosis lung disease', '36 web based clinical vignettes (i.e. case simulations) were designed using clinical data from patients aged 8-18\u202fyears, randomly selected from two CF centres in The Netherlands']","['CT', 'care mention chest radiography (CR) but not chest computed tomography (CT', 'chest computed tomography and chest radiography']","['inhaled antibiotics', 'need for hospitalization', 'Radiological information (CT or CR', 'mycobacterial cultures']","[{'cui': 'C0239307', 'cui_str': 'European (ethnic group)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4517573', 'cui_str': 'One hundred and forty-three'}, {'cui': 'C4517595', 'cui_str': '167 (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0010674', 'cui_str': 'Mucoviscidosis'}, {'cui': 'C0392164', 'cui_str': 'Pulmonary Cystic Fibrosis'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}]","[{'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C0034571', 'cui_str': 'radiography'}, {'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}]","[{'cui': 'C0004048', 'cui_str': 'Inhalation'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0220814', 'cui_str': 'culture'}]",143.0,0.0595781,"CT was associated with a significant increase in antifungal treatment (Risk Ratio (RR) 2.8 (1.3-6.0, p = .02)), bronchoscopies (RR 1.6 (1.1-2.5, p = .04)), mycobacterial cultures (RR 1.3 (1.0-1.5, p = .02)), and 'need for hospitalization' (i.e. intravenous antibiotics and/or bronchoscopy) (RR 1.4 (1.0-1.9, p = .03)).","[{'ForeName': 'Carla F', 'Initials': 'CF', 'LastName': 'Bortoluzzi', 'Affiliation': ""Unità Fibrosi Cistica, Pediatria, ULSS 2 Ospedale Ca' Foncello, Treviso, Italy.""}, {'ForeName': 'Eleonora', 'Initials': 'E', 'LastName': 'Pontello', 'Affiliation': ""Unità Fibrosi Cistica, Pediatria, ULSS 2 Ospedale Ca' Foncello, Treviso, Italy.""}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Pintani', 'Affiliation': 'Centro Regionale Fibrosi Cistica, AOUI Verona, Verona, Italy.'}, {'ForeName': 'Karin M', 'Initials': 'KM', 'LastName': 'de Winter-de Groot', 'Affiliation': ""Department of Pediatric Pulmonology, Wilhelmina Children's Hospital - University Medical Centre Utrecht, Utrecht University, Utrecht, The Netherlands.""}, {'ForeName': 'Ciro', 'Initials': 'C', 'LastName': ""D'Orazio"", 'Affiliation': 'Centro Regionale Fibrosi Cistica, AOUI Verona, Verona, Italy.'}, {'ForeName': 'Baroukh M', 'Initials': 'BM', 'LastName': 'Assael', 'Affiliation': 'Adult Cystic Fibrosis Centre, University of Milano, Italy.'}, {'ForeName': 'M G Myriam', 'Initials': 'MGM', 'LastName': 'Hunink', 'Affiliation': ""Department of Pediatric Pulmonology and Allergology, Erasmus MC - Sophia Children's Hospital, Rotterdam, The Netherlands; Department of Epidemiology, Erasmus MC, Rotterdam, The Netherlands; Department of Radiology and Nuclear Medicine, Erasmus MC, Rotterdam, The Netherlands; Centre for Health Decision Science, Harvard T.H. Chan School of Public Health, Boston, USA.""}, {'ForeName': 'Harm A W M', 'Initials': 'HAWM', 'LastName': 'Tiddens', 'Affiliation': ""Department of Pediatric Pulmonology and Allergology, Erasmus MC - Sophia Children's Hospital, Rotterdam, The Netherlands.""}, {'ForeName': 'Daan', 'Initials': 'D', 'LastName': 'Caudri', 'Affiliation': ""Department of Pediatric Pulmonology and Allergology, Erasmus MC - Sophia Children's Hospital, Rotterdam, The Netherlands; Telethon Kids Institute, University of Western Australia, Perth, Australia. Electronic address: d.caudri@erasmusmc.nl.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of cystic fibrosis : official journal of the European Cystic Fibrosis Society,['10.1016/j.jcf.2019.08.005'] 1497,31894022,Analysis of curative effects of human gamma globulin on bacterial pneumonia in pediatric patients.,"The main aim of this study was to investigate the effects of human gamma globulin (HGG) on inflammation targets in children. A total of 80 children were randomly divided into observation and control group with 40 cases in each group. The control group was given comprehensive treatment while the observation group was treated with HGG. The time of disappearance of clinical signs and symptoms, time of improvement of pulmonary iconography, inflammatory indices, time and degree of improvement of lung function and adverse reactions were observed. The total effective rate in the observation group was 97.5% and significantly higher than control group (77.5%). The time of fever clearance, imaging improvement as well as cough and pulmonary rales disappearance in the observation group was shorter than control group. After treatment, the levels of inflammatory indicators such as erythrocyte sedimentation rate (ESR) and C-reaction protein (CRP) in the observation group were lower than control group. No obvious abnormalities of urea nitrogen, creatinine, serum alanine amino transferase (ALT) and aspartate amino transferase (AST) were found in the two groups. Overall, HGG effectively shortened the course of RMPP, improved the cure rate, reduced the inflammatory reaction and promoted the recovery of lung function without obvious adverse reaction.",2019,"No obvious abnormalities of urea nitrogen, creatinine, serum alanine amino transferase (ALT) and aspartate amino transferase (AST) were found in the two groups.","['80 children', 'children', 'pediatric patients']","['human gamma globulin (HGG', 'HGG', 'human gamma globulin']","['recovery of lung function without obvious adverse reaction', 'inflammatory reaction', 'time of disappearance of clinical signs and symptoms, time of improvement of pulmonary iconography, inflammatory indices, time and degree of improvement of lung function and adverse reactions', 'time of fever clearance, imaging improvement as well as cough and pulmonary rales disappearance', 'total effective rate', 'bacterial pneumonia', 'urea nitrogen, creatinine, serum alanine amino transferase (ALT) and aspartate amino transferase (AST', 'levels of inflammatory indicators such as erythrocyte sedimentation rate (ESR) and C-reaction protein (CRP', 'cure rate']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0860681', 'cui_str': 'Immunogammaglobulin'}]","[{'cui': 'C0024119', 'cui_str': 'Lung Function Tests'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction (disorder)'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0037088', 'cui_str': 'Signs and Symptoms'}, {'cui': 'C4522268', 'cui_str': 'Pulmonary'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C0015967', 'cui_str': 'Hyperthermia'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C0010200', 'cui_str': 'Complaining of cough (finding)'}, {'cui': 'C0034642', 'cui_str': 'Rales'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C0004626', 'cui_str': 'Pneumonia, Bacterial'}, {'cui': 'C1291218', 'cui_str': 'Urea nitrogen (substance)'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0001898', 'cui_str': 'L-alanine'}, {'cui': 'C0040676', 'cui_str': 'Transferase'}, {'cui': 'C0085845', 'cui_str': 'Aspartate'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C1176468', 'cui_str': 'Erythrocyte sedimentation rate measurement'}, {'cui': 'C0443286', 'cui_str': 'Reaction (qualifier value)'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}]",80.0,0.0258306,"No obvious abnormalities of urea nitrogen, creatinine, serum alanine amino transferase (ALT) and aspartate amino transferase (AST) were found in the two groups.","[{'ForeName': 'Nan', 'Initials': 'N', 'LastName': 'Xu', 'Affiliation': 'Department of Pediatrics, Wuxi Branch of Zhongda Hospital, South-east University, Wuxi, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'Department of Pediatrics, Wuxi Branch of Zhongda Hospital, South-east University, Wuxi, China.'}, {'ForeName': 'Han', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Department of Pediatrics, Zhongda Hospital of Southeast University, Nanjing, China.'}, {'ForeName': 'Lijuan', 'Initials': 'L', 'LastName': 'Qian', 'Affiliation': 'Department of Pediatrics, Zhongda Hospital of Southeast University, Nanjing, China.'}, {'ForeName': 'Lixing', 'Initials': 'L', 'LastName': 'Qiao', 'Affiliation': 'Department of Pediatrics, Zhongda Hospital of Southeast University, Nanjing, China.'}]",Pakistan journal of pharmaceutical sciences,[] 1498,31894026,Study on the treatment of advanced lung adenocarcinoma in the elderly with pemetrexed combined with platinum drugs.,"To study the treatment of advanced lung adenocarcinoma in the elderly with pemetrexed combined with platinum drugs. 200 elderly patients who had been treated for advanced lung adenocarcinoma in our hospital were enrolled as research objects. They were randomly divided into control group and research group, each containing 100 patients. The control group was given Pemetrexed therapy and routine nursing mode, while the research group was given pemetrexed combined with platinum drugs and evidence-based nursing mode. The therapeutic effect and nursing effect of the two groups were compared. The overall treatment effective rate of the research was 85.00% and that of the control group was 60.00%, indicating the research group had significant advantage over the control group, p<0.05. The incidence of adverse reactions including nausea, vomiting, constipation, diarrhea, bone marrow suppression, fatigue and fatigue, and hair loss was significantly lower in the research group (22.00%) than that in the control group (45.00%), p<0.05. The quality of life of the research group was higher than that of the control group, p<0.05. For the elderly patients with advanced lung adenocarcinoma, the implementation of pemetrexed combined with platinum drug can help patients get better treatment results.",2019,"The quality of life of the research group was higher than that of the control group, p<0.05.","['advanced lung adenocarcinoma in the elderly with pemetrexed combined with platinum drugs', 'elderly patients with advanced lung adenocarcinoma', '200 elderly patients who had been treated for advanced lung adenocarcinoma in our hospital were enrolled as research objects']","['Pemetrexed therapy and routine nursing mode, while the research group was given pemetrexed combined with platinum drugs and evidence-based nursing mode']","['quality of life', 'therapeutic effect and nursing effect', 'nausea, vomiting, constipation, diarrhea, bone marrow suppression, fatigue and fatigue, and hair loss']","[{'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0152013', 'cui_str': 'Adenocarcinoma of Lung'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0210657', 'cui_str': 'pemetrexed'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for (contextual qualifier) (qualifier value)'}, {'cui': 'C0347997', 'cui_str': 'Physical object'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0028678', 'cui_str': 'nursing care'}, {'cui': 'C0035168'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0210657', 'cui_str': 'pemetrexed'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C2350328', 'cui_str': 'Evidence-Based Nursing'}]","[{'cui': 'C0034380'}, {'cui': 'C1527144'}, {'cui': 'C0028678', 'cui_str': 'nursing care'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0854467', 'cui_str': 'Myelosuppression (finding)'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0002170', 'cui_str': 'Hair Loss'}]",200.0,0.0143575,"The quality of life of the research group was higher than that of the control group, p<0.05.","[{'ForeName': 'Xiumin', 'Initials': 'X', 'LastName': 'Ba', 'Affiliation': 'Radiotherapy Department, The Second Hospital of Jilin University, Changchun, China.'}, {'ForeName': 'Jinhua', 'Initials': 'J', 'LastName': 'Han', 'Affiliation': 'Radiotherapy Department, The Second Hospital of Jilin University, Changchun, China.'}, {'ForeName': 'Guohong', 'Initials': 'G', 'LastName': 'Zhao', 'Affiliation': 'Colorectal and Anal Surgery, The Second Hospital of Jilin University, Changchun, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Bian', 'Affiliation': 'Radiotherapy Department, The Second Hospital of Jilin University, Changchun, China.'}]",Pakistan journal of pharmaceutical sciences,[] 1499,31495220,Left Main Coronary Artery Disease Revascularization According to the SYNTAX Score.,"BACKGROUND The SYNTAX (Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery) score (SS), a measure of anatomic coronary artery disease (CAD) extent and complexity, has proven useful in past studies to determine the absolute and relative prognosis after revascularization with percutaneous coronary intervention (PCI) versus coronary artery bypass grafting (CABG). We sought to assess contemporary outcomes after PCI and CABG in patients with left main CAD according to SS and revascularization type from a large randomized trial. METHODS The EXCEL trial (Evaluation of XIENCE Versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization) randomized patients with left main CAD and site-assessed SS≤32 to PCI with everolimus-eluting stents or CABG. Four-year outcomes were examined according to angiographic core laboratory-assessed SS using multivariable Cox proportional hazards regression. RESULTS A total of 1840 patients with left main CAD randomized to PCI (n=914) versus CABG (n=926) had angiographic core laboratory SS assessment. The mean SS was 26.5±9.3 (range 5-74); 24.1% of patients had angiographic core laboratory-assessed SS ≥33. The 4-year rate of the primary major adverse cardiac event end point of death, stroke, or myocardial infarction was similar between PCI and CABG (18.6% versus 16.7%, respectively; P=0.40) and did not vary according to SS (P interaction =0.33). Rates of ischemia-driven revascularization rose with increasing SS after PCI, but not after CABG. As a result, the major secondary composite end point of major adverse cardiac or cerebrovascular events (major adverse cardiac event or ischemia-driven revascularization) occurred more frequently with PCI than CABG (28.0% versus 22.0%, P=0.01), a difference which rose progressively with increasing SS (P interaction =0.03). CONCLUSIONS In the EXCEL trial, the 4-year primary composite major adverse cardiac event end point of death, myocardial infarction, or stroke was similar after PCI with everolimus-eluting stents and CABG and was independent of the baseline anatomic complexity and extent of CAD. In contrast, the relative and absolute hazard of major adverse cardiac or cerebrovascular events with PCI compared with CABG rose progressively with the SS. These data should be considered by the heart team when deciding between PCI versus CABG for revascularization in patients with left main CAD. CLINICAL TRIAL REGISTRATION URL: https://www.clinicaltrials.gov. Unique identifier NCT01205776.",2019,"Rates of ischemia-driven revascularization rose with increasing SS after PCI, but not after CABG.","['patients with left main CAD', '1840 patients with left main CAD randomized to PCI (n=914) versus CABG (n=926) had angiographic core laboratory SS assessment', 'Left Main Coronary Artery Disease Revascularization', 'Left Main Revascularization) randomized patients with left main CAD and site-assessed SS≤32 to PCI with everolimus-eluting stents or CABG', 'patients with left main CAD according to SS and revascularization type from a large randomized trial']","['XIENCE Versus Coronary Artery Bypass Surgery', 'PCI and CABG', 'percutaneous coronary intervention (PCI) versus coronary artery bypass grafting (CABG', 'Percutaneous Coronary Intervention With Taxus and Cardiac Surgery) score (SS']","['mean SS', '4-year primary composite major adverse cardiac event end point of death, myocardial infarction, or stroke', 'baseline anatomic complexity and extent of CAD', '4-year rate of the primary major adverse cardiac event end point of death, stroke, or myocardial infarction', 'relative and absolute hazard of major adverse cardiac or cerebrovascular events', 'major adverse cardiac or cerebrovascular events (major adverse cardiac event or ischemia-driven revascularization']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205225', 'cui_str': 'Principal (qualifier value)'}, {'cui': 'C0010055', 'cui_str': 'Coronary Artery Bypass Grafting'}, {'cui': 'C0444669', 'cui_str': 'Core (qualifier value)'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C1299433', 'cui_str': 'Left main coronary artery disease'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0541315', 'cui_str': 'everolimus'}, {'cui': 'C0038257', 'cui_str': 'Stents'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}]","[{'cui': 'C0010055', 'cui_str': 'Coronary Artery Bypass Grafting'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}, {'cui': 'C0330199', 'cui_str': 'Taxus'}, {'cui': 'C0524727', 'cui_str': 'Surgery, Cardiac'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0220784', 'cui_str': 'Anatomic (qualifier value)'}, {'cui': 'C0439792', 'cui_str': 'Extents (qualifier value)'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C0004379', 'cui_str': 'Drivings, Automobile'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}]",1840.0,0.0768079,"Rates of ischemia-driven revascularization rose with increasing SS after PCI, but not after CABG.","[{'ForeName': 'Evan', 'Initials': 'E', 'LastName': 'Shlofmitz', 'Affiliation': 'Cardiovascular Research Foundation, NY (E.S., P.G., S.C., O.D., O.B.-Y., A.C., B.R., G.M., G.W.S.).'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Généreux', 'Affiliation': 'Cardiovascular Research Foundation, NY (E.S., P.G., S.C., O.D., O.B.-Y., A.C., B.R., G.M., G.W.S.).'}, {'ForeName': 'Shmuel', 'Initials': 'S', 'LastName': 'Chen', 'Affiliation': 'Cardiovascular Research Foundation, NY (E.S., P.G., S.C., O.D., O.B.-Y., A.C., B.R., G.M., G.W.S.).'}, {'ForeName': 'Ovidiu', 'Initials': 'O', 'LastName': 'Dressler', 'Affiliation': 'Cardiovascular Research Foundation, NY (E.S., P.G., S.C., O.D., O.B.-Y., A.C., B.R., G.M., G.W.S.).'}, {'ForeName': 'Ori', 'Initials': 'O', 'LastName': 'Ben-Yehuda', 'Affiliation': 'Cardiovascular Research Foundation, NY (E.S., P.G., S.C., O.D., O.B.-Y., A.C., B.R., G.M., G.W.S.).'}, {'ForeName': 'Marie-Claude', 'Initials': 'MC', 'LastName': 'Morice', 'Affiliation': 'Institut Cardiovasculaire Paris Sud, Ramsay Générale de Santé, Massy, France (M.-C.M.).'}, {'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Puskas', 'Affiliation': ""Mount Sinai Saint Luke's, NY (J.D.P.).""}, {'ForeName': 'David P', 'Initials': 'DP', 'LastName': 'Taggart', 'Affiliation': 'John Radcliffe Hospital, Oxford, United Kingdom (D.P.T.).'}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Kandzari', 'Affiliation': 'Piedmont Heart Institute, Atlanta, GA (D.E.K.).'}, {'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'Crowley', 'Affiliation': 'Cardiovascular Research Foundation, NY (E.S., P.G., S.C., O.D., O.B.-Y., A.C., B.R., G.M., G.W.S.).'}, {'ForeName': 'Björn', 'Initials': 'B', 'LastName': 'Redfors', 'Affiliation': 'Cardiovascular Research Foundation, NY (E.S., P.G., S.C., O.D., O.B.-Y., A.C., B.R., G.M., G.W.S.).'}, {'ForeName': 'Ghazaleh', 'Initials': 'G', 'LastName': 'Mehdipoor', 'Affiliation': 'Cardiovascular Research Foundation, NY (E.S., P.G., S.C., O.D., O.B.-Y., A.C., B.R., G.M., G.W.S.).'}, {'ForeName': 'Arie Pieter', 'Initials': 'AP', 'LastName': 'Kappetein', 'Affiliation': 'Thoraxcenter, Erasmus Medical Center, Rotterdam, the Netherlands (A.P.K.).'}, {'ForeName': 'Joseph F', 'Initials': 'JF', 'LastName': 'Sabik', 'Affiliation': 'UH Cleveland Medical Center, Cleveland, OH (J.F.S.).'}, {'ForeName': 'Patrick W', 'Initials': 'PW', 'LastName': 'Serruys', 'Affiliation': 'Imperial College London, United Kingdom (P.W.S.).'}, {'ForeName': 'Gregg W', 'Initials': 'GW', 'LastName': 'Stone', 'Affiliation': 'Cardiovascular Research Foundation, NY (E.S., P.G., S.C., O.D., O.B.-Y., A.C., B.R., G.M., G.W.S.).'}]",Circulation. Cardiovascular interventions,['10.1161/CIRCINTERVENTIONS.118.008007'] 1500,31894731,Reducing time in acute hospitals: A stepped-wedge randomised control trial of a specialist palliative care intervention in residential care homes.,"BACKGROUND Care home residents are frequently transferred to hospital, rather than provided with appropriate and timely specialist care in the care home. AIM To determine whether a model of care providing specialist palliative care in care homes, called Specialist Palliative Care Needs Rounds, could reduce length of stay in hospital. DESIGN Stepped-wedge randomised control trial. The primary outcome was length of stay in acute care (over 24-h duration), with secondary outcomes being the number and cost of hospitalisations. Care homes were randomly assigned to cross over from control to intervention using a random number generator; masking was not possible due to the nature of the intervention. Analyses were by intention to treat. The trial was registered with ANZCTR: ACTRN12617000080325. Data were collected between 1 February 2017 and 30 June 2018. SETTING/PARTICIPANTS 1700 residents in 12 Australian care homes for older people. RESULTS Specialist Palliative Care Needs Rounds led to reduced length of stay in hospital (unadjusted difference: 0.5 days; adjusted difference: 0.22 days with 95% confidence interval: -0.44, -0.01 and p = 0.038). The intervention also provided a clinically significant reduction in the number of hospitalisations by 23%, from 5.6 to 4.3 per facility-month. A conservative estimate of annual net cost-saving from reduced admissions was A$1,759,011 (US$1.3 m; UK£0.98 m). CONCLUSION The model of care significantly reduces hospitalisations through provision of outreach by specialist palliative care clinicians. The data offer substantial evidence for Specialist Palliative Care Needs Rounds to reduce hospitalisations in older people approaching end of life, living in care homes.",2020,"The intervention also provided a clinically significant reduction in the number of hospitalisations by 23%, from 5.6 to 4.3 per facility-month.","['residential care homes', 'Data were collected between 1 February 2017 and 30 June 2018', '1700 residents in 12 Australian care homes for older people', 'Care homes', 'acute hospitals']",['specialist palliative care intervention'],"['length of stay in hospital', 'number of hospitalisations', 'length of stay in acute care (over 24-h duration), with secondary outcomes being the number and cost of hospitalisations']","[{'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}]","[{'cui': 'C1273400', 'cui_str': 'Specialist palliative care'}]","[{'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0010186', 'cui_str': 'Cost'}]",1700.0,0.222519,"The intervention also provided a clinically significant reduction in the number of hospitalisations by 23%, from 5.6 to 4.3 per facility-month.","[{'ForeName': 'Liz', 'Initials': 'L', 'LastName': 'Forbat', 'Affiliation': 'Faculty of Social Sciences, University of Stirling, Stirling, UK.'}, {'ForeName': 'Wai-Man', 'Initials': 'WM', 'LastName': 'Liu', 'Affiliation': 'Australian National University, Canberra, ACT, Australia.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Koerner', 'Affiliation': 'Australian Catholic University, Canberra, ACT, Australia.'}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Lam', 'Affiliation': 'University of Technology Sydney, Ultimo, NSW, Australia.'}, {'ForeName': 'Juliane', 'Initials': 'J', 'LastName': 'Samara', 'Affiliation': 'Calvary Health Care, Canberra, ACT, Australia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Chapman', 'Affiliation': 'Australian National University, Canberra, ACT, Australia.'}, {'ForeName': 'Nikki', 'Initials': 'N', 'LastName': 'Johnston', 'Affiliation': 'Calvary Health Care, Canberra, ACT, Australia.'}]",Palliative medicine,['10.1177/0269216319891077'] 1501,31846024,Effects of Biopsychosocial Education on the Clinical Judgments of Medical Students and GP Trainees Regarding Future Risk of Disability in Chronic Lower Back Pain: A Randomized Control Trial.,"BACKGROUND Chronic lower back pain (CLBP) is a major health care burden and often results in workplace absenteeism. It is a priority for appropriate management of CLBP to get individuals back to work as early as possible. Interventions informed by the flags approach, which integrates cognitive and behavioral approaches via identification of biopsychosocial barriers to recovery, have resulted in reduced pain-related work absences and increased return to work for individuals with CLBP. However, research indicates that physicians' adherence to biopsychosocial guidelines is low. OBJECTIVE The current study examined the effects of a flags approach-based educational intervention on clinical judgments of medical students and general practitioner (GP) trainees regarding the risk of future disability of CLBP patients. DESIGN Randomized controlled trial (trial registration number: ISRCTN53670726). SETTING University classroom. SUBJECTS Medical students and GP trainees. METHODS Using 40 fictional CLBP cases, differences in clinical judgment accuracy, weighting, and speed (experimental N = 32) were examined pre- and postintervention, as were flags approach knowledge, pain attitudes and beliefs, and empathy, in comparison with a no-intervention control group (control N = 31). RESULTS Results revealed positive effects of the educational intervention on flags approach knowledge, pain-related attitudes and beliefs, and judgment weighting of psychologically based cues; results are discussed in light of existing theory and research. CONCLUSIONS Short flags approach-based educational video interventions on clinical judgment-making regarding the risk of future disability of CLBP patients may provide opportunities to gain biopsychosocial knowledge, overcome associated attitude barriers, and facilitate development of clinical judgment-making more aligned with psychological cues.",2020,"RESULTS Results revealed positive effects of the educational intervention on flags approach knowledge, pain-related attitudes and beliefs, and judgment weighting of psychologically based cues; results are discussed in light of existing theory and research. ","['medical students and general practitioner (GP) trainees regarding the risk of future disability of CLBP patients', 'University classroom', 'Medical students and GP trainees', 'Medical Students and GP Trainees Regarding Future Risk of Disability in Chronic Lower Back Pain', 'Chronic lower back pain (CLBP', 'CLBP patients']","['flags approach-based educational intervention', 'Biopsychosocial Education', 'educational intervention']","['flags approach knowledge, pain-related attitudes and beliefs, and judgment weighting of psychologically based cues', 'flags approach knowledge, pain attitudes and beliefs, and empathy', 'clinical judgment accuracy, weighting, and speed (experimental N\u2009=\u200932']","[{'cui': 'C0038495', 'cui_str': 'Students, Medical'}, {'cui': 'C0017319', 'cui_str': 'Physicians, General Practice'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0016884', 'cui_str': 'Future'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C0004604', 'cui_str': 'Backache'}]","[{'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0022423', 'cui_str': 'Judgment'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0013989', 'cui_str': 'Empathy'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}]",,0.0525744,"RESULTS Results revealed positive effects of the educational intervention on flags approach knowledge, pain-related attitudes and beliefs, and judgment weighting of psychologically based cues; results are discussed in light of existing theory and research. ","[{'ForeName': 'Christopher P', 'Initials': 'CP', 'LastName': 'Dwyer', 'Affiliation': 'Centre for Pain Research, National University of Ireland, Galway, Ireland.'}, {'ForeName': 'Pádraig', 'Initials': 'P', 'LastName': 'MacNeela', 'Affiliation': 'School of Psychology, National University of Ireland, Galway, Ireland.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Durand', 'Affiliation': 'School of Psychology, National University of Ireland, Galway, Ireland.'}, {'ForeName': 'Laura L', 'Initials': 'LL', 'LastName': ""O'Connor"", 'Affiliation': ''}, {'ForeName': 'Chris J', 'Initials': 'CJ', 'LastName': 'Main', 'Affiliation': 'Research Institute of Primary Care and Health Sciences, Keele University, Staffordshire, England.'}, {'ForeName': 'Phoebe E', 'Initials': 'PE', 'LastName': 'McKenna-Plumley', 'Affiliation': ''}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Hamm', 'Affiliation': 'Department of Family & Preventive Medicine, University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, USA.'}, {'ForeName': 'Bronagh', 'Initials': 'B', 'LastName': 'Reynolds', 'Affiliation': ''}, {'ForeName': 'Sinéad', 'Initials': 'S', 'LastName': 'Conneely', 'Affiliation': 'School of Psychology, National University of Ireland, Galway, Ireland.'}, {'ForeName': 'Brian W', 'Initials': 'BW', 'LastName': 'Slattery', 'Affiliation': 'School of Psychology, National University of Ireland, Galway, Ireland.'}, {'ForeName': 'Darragh', 'Initials': 'D', 'LastName': 'Taheny', 'Affiliation': ''}, {'ForeName': 'Saoirse', 'Initials': 'S', 'LastName': 'NicGabhainn', 'Affiliation': 'Discipline of Health Promotion, National University of Ireland, Galway, Ireland.'}, {'ForeName': 'Andrew W', 'Initials': 'AW', 'LastName': 'Murphy', 'Affiliation': 'Discipline of General Practice, National University of Ireland, Galway, Ireland.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Kropmans', 'Affiliation': 'Discipline of Medical Informatics and Education, National University of Ireland, Galway, Ireland.'}, {'ForeName': 'Brian E', 'Initials': 'BE', 'LastName': 'McGuire', 'Affiliation': 'School of Psychology, National University of Ireland, Galway, Ireland.'}]","Pain medicine (Malden, Mass.)",['10.1093/pm/pnz284'] 1502,31951771,"Long-term immunogenicity and immune memory response to the hepatitis B antigen in the RTS,S/AS01 E malaria vaccine in African children: a randomized trial.","RTS,S/AS01 E malaria vaccine contains the hepatitis B virus surface antigen and may thus serve as a potential hepatitis B vaccine. To evaluate the impact of RTS,S/AS01 E when implemented in the Expanded Program of Immunization, infants 8-12 weeks old were randomized to receive either RTS,S/AS01 E or a licensed hepatitis B control vaccine (HepB), both co-administered with various combinations of the following childhood vaccines: diphtheria-tetanus-acellular pertussis- Haemophilus influenzae type b, trivalent oral poliovirus, pneumococcal non-typeable Haemophilus influenzae protein D conjugate and human rotavirus vaccine. Long-term persistence of antibodies against the circumsporozoite (CS) protein and hepatitis B surface antigen (HBsAg) were assessed, together with the immune memory response to the HB antigen following a booster dose of HepB vaccine. Subgroups receiving RTS,S or the HepB control vaccine were pooled into RTS,S groups and HepB groups, respectively. One month post-HepB booster vaccination, 100% of participants in the RTS,S groups and 98.3% in the control groups had anti-HBs antibody concentrations ≥10 mIU/mL with the geometric mean concentrations (GMCs) at 46634.7 mIU/mL (95% CI: 40561.3; 53617.6) and 9258.2 mIU/mL (95% CI: 6925.3; 12377.0), respectively. Forty-eight months post-primary vaccination anti-CS antibody GMCs ranged from 2.3 EU/mL to 2.7 EU/mL in the RTS,S groups compared to 1.1 EU/mL in the control groups. Hepatitis B priming with the RTS,S/AS01 E vaccine was effective and resulted in a memory response to HBsAg as shown by the robust booster response following an additional dose of HepB vaccine. RTS,S/AS01E when co-administered with PHiD-CV, HRV and other childhood vaccines, had an acceptable safety profile.",2020,"Hepatitis B priming with the RTS,S/AS01 E vaccine was effective and resulted in a memory response to HBsAg as shown by the robust booster response following an additional dose of HepB vaccine.","['African children', 'infants 8-12\xa0weeks old']","['diphtheria-tetanus-acellular pertussis- Haemophilus influenzae', 'RTS,S/AS01 E or a licensed hepatitis B control vaccine (HepB), both co-administered with various combinations of the following childhood vaccines']",['anti-HBs antibody concentrations ≥10'],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C0012546', 'cui_str': 'Corynebacterium diphtheriae Infection'}, {'cui': 'C0043167', 'cui_str': 'Pertussis'}, {'cui': 'C0018483', 'cui_str': 'Haemophilus influenzae'}, {'cui': 'C0023636', 'cui_str': 'Permits'}, {'cui': 'C0019163', 'cui_str': 'Hepatitis B Virus Infection'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C3540029', 'cui_str': 'various other anti-acne preparation combinations for topical use in ATC'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0231335', 'cui_str': 'Childhood (finding)'}]","[{'cui': 'C0948254', 'cui_str': 'Anti-HBs antibody'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",,0.0415345,"Hepatitis B priming with the RTS,S/AS01 E vaccine was effective and resulted in a memory response to HBsAg as shown by the robust booster response following an additional dose of HepB vaccine.","[{'ForeName': 'Innocent', 'Initials': 'I', 'LastName': 'Valéa', 'Affiliation': 'Unité de Recherche Clinique de Nanoro, Institut de Recherche en Sciences de la Santé , Nanoro, Burkina Faso.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Adjei', 'Affiliation': 'School of Medical Sciences, KNUST (Agogo Presbyterian Hospital) , Kumasi, Ghana.'}, {'ForeName': 'Effua', 'Initials': 'E', 'LastName': 'Usuf', 'Affiliation': 'Vaccine, GSK , Wavre, Belgium.'}, {'ForeName': 'Ousmane', 'Initials': 'O', 'LastName': 'Traore', 'Affiliation': 'Unité de Recherche Clinique de Nanoro, Institut de Recherche en Sciences de la Santé , Nanoro, Burkina Faso.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Ansong', 'Affiliation': 'School of Medical Sciences, KNUST (Agogo Presbyterian Hospital) , Kumasi, Ghana.'}, {'ForeName': 'Halidou', 'Initials': 'H', 'LastName': 'Tinto', 'Affiliation': 'Unité de Recherche Clinique de Nanoro, Institut de Recherche en Sciences de la Santé , Nanoro, Burkina Faso.'}, {'ForeName': 'Harry', 'Initials': 'H', 'LastName': 'Owusu Boateng', 'Affiliation': 'School of Medical Sciences, KNUST (Agogo Presbyterian Hospital) , Kumasi, Ghana.'}, {'ForeName': 'Athanase Mwinessobaonfou', 'Initials': 'AM', 'LastName': 'Some', 'Affiliation': 'Unité de Recherche Clinique de Nanoro, Institut de Recherche en Sciences de la Santé , Nanoro, Burkina Faso.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Buabeng', 'Affiliation': 'School of Medical Sciences, KNUST (Agogo Presbyterian Hospital) , Kumasi, Ghana.'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Vekemans', 'Affiliation': 'Vaccine, GSK , Wavre, Belgium.'}, {'ForeName': 'Amos', 'Initials': 'A', 'LastName': 'Kotey', 'Affiliation': 'School of Medical Sciences, KNUST (Agogo Presbyterian Hospital) , Kumasi, Ghana.'}, {'ForeName': 'Pascale', 'Initials': 'P', 'LastName': 'Vandoolaeghe', 'Affiliation': 'Vaccine, GSK , Wavre, Belgium.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Cullinane', 'Affiliation': 'Vaccine, GSK , Wavre, Belgium.'}, {'ForeName': 'Magali', 'Initials': 'M', 'LastName': 'Traskine', 'Affiliation': 'Vaccine, GSK , Wavre, Belgium.'}, {'ForeName': 'Florence', 'Initials': 'F', 'LastName': 'Ouedraogo', 'Affiliation': 'Unité de Recherche Clinique de Nanoro, Institut de Recherche en Sciences de la Santé , Nanoro, Burkina Faso.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Sambian', 'Affiliation': 'School of Medical Sciences, KNUST (Agogo Presbyterian Hospital) , Kumasi, Ghana.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Lievens', 'Affiliation': 'Vaccine, GSK , Wavre, Belgium.'}, {'ForeName': 'Marc Christian', 'Initials': 'MC', 'LastName': 'Tahita', 'Affiliation': 'Unité de Recherche Clinique de Nanoro, Institut de Recherche en Sciences de la Santé , Nanoro, Burkina Faso.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Jongert', 'Affiliation': 'Vaccine, GSK , Wavre, Belgium.'}, {'ForeName': 'Palpouguini', 'Initials': 'P', 'LastName': 'Lompo', 'Affiliation': 'Unité de Recherche Clinique de Nanoro, Institut de Recherche en Sciences de la Santé , Nanoro, Burkina Faso.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Idriss', 'Affiliation': 'School of Medical Sciences, KNUST (Agogo Presbyterian Hospital) , Kumasi, Ghana.'}, {'ForeName': 'Dorota', 'Initials': 'D', 'LastName': 'Borys', 'Affiliation': 'Vaccine, GSK , Wavre, Belgium.'}, {'ForeName': 'Sayouba', 'Initials': 'S', 'LastName': 'Ouedraogo', 'Affiliation': 'Unité de Recherche Clinique de Nanoro, Institut de Recherche en Sciences de la Santé , Nanoro, Burkina Faso.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Prempeh', 'Affiliation': 'School of Medical Sciences, KNUST (Agogo Presbyterian Hospital) , Kumasi, Ghana.'}, {'ForeName': 'Lode', 'Initials': 'L', 'LastName': 'Schuerman', 'Affiliation': 'Vaccine, GSK , Wavre, Belgium.'}, {'ForeName': 'Hermann', 'Initials': 'H', 'LastName': 'Sorgho', 'Affiliation': 'Unité de Recherche Clinique de Nanoro, Institut de Recherche en Sciences de la Santé , Nanoro, Burkina Faso.'}, {'ForeName': 'Tsiri', 'Initials': 'T', 'LastName': 'Agbenyega', 'Affiliation': 'School of Medical Sciences, KNUST (Agogo Presbyterian Hospital) , Kumasi, Ghana.'}]",Human vaccines & immunotherapeutics,['10.1080/21645515.2019.1695457'] 1503,31859197,Comparison of intradermal mesotherapy with systemic therapy in the treatment of low back pain: A prospective randomized study.,"INTRODUCTION Musculoskeletal pain such as low back pain (LBP) are routinely encountered in the ED and contribute to ED overcrowding. The aim of our study was to compare the efficiency of mesotherapy with systemic therapy in pain control in patients with lumbar disk herniation. METHODS We conducted this prospective parallel randomized controlled trial with the patients admitted to the emergency department with low back pain related to herniated lumbar disk. Mesotherapy was performed to one group, while intravenous dexketoprofen was administered to the control group. Changes in pain intensity at 15th minute, 30th minute, 60th minute and 24th hours after treatment using Visual Analogue Scale (VAS), need to use analgesic drug within 24 h after treatment, and adverse effect of the treatment methods were compared between groups. RESULTS The decreases in pain intensity were statistically significantly higher in mesotherapy group for all time intervals. The need to use analgesics was statistically significantly three fold higher in the systemic therapy group. There was no statistically significant difference in having any adverse effect between study groups during one-week follow-up period. CONCLUSIONS Changes in medical practices, from the systemic administration of NSAIDs to the minimally invasive techniques such as mesotherapy with potent efficacy and minimal side effects, may enhance the ability of EDs to meet the waiting time targets and improve patient's satisfaction.",2020,The need to use analgesics was statistically significantly three fold higher in the systemic therapy group.,"['low back pain', 'patients with lumbar disk herniation', 'patients admitted to the emergency department with low back pain related to herniated lumbar disk']","['intradermal mesotherapy with systemic therapy', 'mesotherapy with systemic therapy', 'dexketoprofen', 'Mesotherapy']","['Visual Analogue Scale (VAS), need to use analgesic drug', 'pain intensity', 'adverse effect']","[{'cui': 'C0024031', 'cui_str': 'Low Back Ache'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0024090', 'cui_str': 'Lumbar Region'}, {'cui': 'C1705370', 'cui_str': 'Disc - unit of product usage'}, {'cui': 'C0019270', 'cui_str': 'Hernia'}, {'cui': 'C0562508', 'cui_str': 'Emergency Room'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}]","[{'cui': 'C2242515', 'cui_str': 'Mesotherapy'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0772505', 'cui_str': 'Dexketoprofen'}]","[{'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0001688', 'cui_str': 'side effects'}]",,0.0708111,The need to use analgesics was statistically significantly three fold higher in the systemic therapy group.,"[{'ForeName': 'Ilker', 'Initials': 'I', 'LastName': 'Akbas', 'Affiliation': 'Department of Emergency Medicine, Bingöl State Hospital, Bingöl, Turkey. Electronic address: akbasilker@gmail.com.'}, {'ForeName': 'Abdullah Osman', 'Initials': 'AO', 'LastName': 'Kocak', 'Affiliation': 'Department of Emergency Medicine, Faculty of Medicine, Ataturk University, Erzurum, Turkey.'}, {'ForeName': 'Meryem Betos', 'Initials': 'MB', 'LastName': 'Kocak', 'Affiliation': 'Department of Family Medicine, Faculty of Medicine, Ataturk University, Erzurum, Turkey.'}, {'ForeName': 'Zeynep', 'Initials': 'Z', 'LastName': 'Cakir', 'Affiliation': 'Department of Emergency Medicine, Faculty of Medicine, Ataturk University, Erzurum, Turkey.'}]",The American journal of emergency medicine,['10.1016/j.ajem.2019.11.044'] 1504,31894030,Comparative effects of 2.5mg levamlodipine and 5mg amlodipine on vascular endothelial function and atherosclerosis.,"This study was designed to compare the efficacy of two different racemic antihypertensive drugs on elderly patients with hypertension and their effects on vascular endothelial function and atherosclerosis. A total of 84 elderly hypertensive patients were randomly divided into control and treatment group with 42 patients in each group. The control group was treated with 2.5mg levamlodipine while the treatment group was given 5mg amlodipine. Total effective rate of the treatment group was 90.5%, higher than the control group, that was 71.4% (P<0.05). The time for recovery of related indicators like blood pressure, the total duration of medication were significantly (P<0.05) shorter in the treatment group. Only 1 case of adverse drug reaction was found in the treatment group while 6 cases in control group. Compared to the control group, the treatment group had massive improvement in fingertip pulse volume, flow-mediated dilation of the brachial arteries and endothelin-1 level, carotid intima-media thickness, plaque length & thickness, and blood pressure after the administration. The rate of satisfaction with the in treatment group was 95.3%, higher than that the control group, which was 78.6%. The study concluded that in elderly patients with hypertension, the treatment with 5mg amlodipine enhanced curative effect, fully improved endothelial function & arteriosclerosis and reduced adverse reactions thereby shortening treatment time.",2019,"Compared to the control group, the treatment group had massive improvement in fingertip pulse volume, flow-mediated dilation of the brachial arteries and endothelin-1 level, carotid intima-media thickness, plaque length & thickness, and blood pressure after the administration.","['elderly patients with hypertension', '84 elderly hypertensive patients']","['levamlodipine', 'amlodipine', 'racemic antihypertensive drugs']","['Total effective rate', 'time for recovery of related indicators like blood pressure, the total duration of medication', 'adverse drug reaction', 'vascular endothelial function and atherosclerosis', 'endothelial function & arteriosclerosis and reduced adverse reactions', 'rate of satisfaction', 'massive improvement in fingertip pulse volume, flow-mediated dilation of the brachial arteries and endothelin-1 level, carotid intima-media thickness, plaque length & thickness, and blood pressure']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}]","[{'cui': 'C2717539', 'cui_str': '2-((2-aminoethoxy)methyl)-4-(2-chlorophenyl)-3-ethoxy-carbonyl-5-methoxycarbonyl-6-methyl-1,4-dihydropyridine'}, {'cui': 'C0051696', 'cui_str': 'Amlodipine'}, {'cui': 'C0003364', 'cui_str': 'Anti-Hypertensive Drugs'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0041755', 'cui_str': 'Drug Side Effects'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0004153', 'cui_str': 'Atherosclerosis'}, {'cui': 'C0003850', 'cui_str': 'Arteriosclerosis'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction (disorder)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0522501', 'cui_str': 'Massive (qualifier value)'}, {'cui': 'C0425580', 'cui_str': 'Pulse volume (observable entity)'}, {'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}, {'cui': 'C1322279', 'cui_str': 'Dilation'}, {'cui': 'C0006087', 'cui_str': 'Brachial Artery'}, {'cui': 'C0079281', 'cui_str': 'Endothelin Type 1'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0162864', 'cui_str': 'Vascular Intima'}, {'cui': 'C0332461', 'cui_str': 'Plaque (morphologic abnormality)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}]",84.0,0.0160915,"Compared to the control group, the treatment group had massive improvement in fingertip pulse volume, flow-mediated dilation of the brachial arteries and endothelin-1 level, carotid intima-media thickness, plaque length & thickness, and blood pressure after the administration.","[{'ForeName': 'Yinhui', 'Initials': 'Y', 'LastName': 'Lu', 'Affiliation': ""Department of Gerontology, Jiangxi Provincial People's Hospital, Nanchang, PR China.""}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Yin', 'Affiliation': ""Department of Gerontology, Jiangxi Provincial People's Hospital, Nanchang, PR China.""}, {'ForeName': 'Xiaohe', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': ""Department of Gerontology, Jiangxi Provincial People's Hospital, Nanchang, PR China.""}, {'ForeName': 'Yuqin', 'Initials': 'Y', 'LastName': 'Fan', 'Affiliation': ""Department of Gerontology, Jiangxi Provincial People's Hospital, Nanchang, PR China.""}, {'ForeName': 'Fenfen', 'Initials': 'F', 'LastName': 'Liu', 'Affiliation': ""Department of Gerontology, Jiangxi Provincial People's Hospital, Nanchang, PR China.""}]",Pakistan journal of pharmaceutical sciences,[] 1505,31894036,Efficacy of different doses of alteplase thrombolysis on acute ischemic stroke in patients.,"Atyplase is a kind of thrombolytic drug with strong fibrin specificity. It can promote the synthesis of fibrinolytic enzymes by combining fibrin and plasminogen in thrombus, and then dissolve thrombus. Ateplase intravenous thrombolysis is the only effective method for stroke treatment proved by evidence-based medicine. The aim of this study was to observe the effect of different doses of ateplase on acute ischemic stroke. They were randomly divided into control group (n=43) and observation group (n=43). The patients in the control group were treated with low-dose alteplase, while those in the observation group were treated with standard-dose alteplase. The control group was treated with 0.6 mg/kg ateplase intravenous thrombolysis, and the observation group was treated with 0.9mg/kg ateplase. The GCS scores on the 1 day was 14.06±1.57 in the control group after treatment, and 13.84±2.48 in the observation group. The NIHSS score was 4.59±1.12 in the control group, and 7.13±1.05 in the observation group. Intravenous thrombolytic therapy with intravenous thrombolytic therapy is effective and safe in the treatment of acute ischemic stroke. At the same time, there were no persistent adverse reactions after treatment, mainly in gingival bleeding, epistaxis, intracranial hemorrhage, gastrointestinal bleeding, and hematuria and so on. The results showed that different doses of alteplase could improve neurological function and living ability of patients. Future studies need to broaden the sample size to study the safety of low and standard doses of alteplase in patients with acute cerebral infarction.",2019,"The NIHSS score was 4.59±1.12 in the control group, and 7.13±1.05 in the observation group.","['acute ischemic stroke', 'patients with acute cerebral infarction', 'patients']","['alteplase', 'thrombolytic therapy', 'standard-dose alteplase', 'low-dose alteplase', 'alteplase thrombolysis']","['adverse reactions', 'neurological function and living ability', 'gingival bleeding, epistaxis, intracranial hemorrhage, gastrointestinal bleeding, and hematuria', 'acute ischemic stroke', 'NIHSS score', 'GCS scores']","[{'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0007785', 'cui_str': 'Cerebral Infarction'}]","[{'cui': 'C0032143', 'cui_str': 'alteplase'}, {'cui': 'C0040044', 'cui_str': 'Thrombolysis, Therapeutic'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0520997', 'cui_str': 'Thrombolysis, function (observable entity)'}]","[{'cui': 'C0559546', 'cui_str': 'Adverse reaction (disorder)'}, {'cui': 'C0027767', 'cui_str': 'Nervous System Physiology'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0017565', 'cui_str': 'Gingival Hemorrhage'}, {'cui': 'C0014591', 'cui_str': 'Nosebleed'}, {'cui': 'C0151699', 'cui_str': 'Intracranial Hemorrhage'}, {'cui': 'C0017181', 'cui_str': 'Gastrointestinal Hemorrhage'}, {'cui': 'C0018965', 'cui_str': 'Hematuria'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.0273199,"The NIHSS score was 4.59±1.12 in the control group, and 7.13±1.05 in the observation group.","[{'ForeName': 'Hongying', 'Initials': 'H', 'LastName': 'Xu', 'Affiliation': 'Department of Critical Care Medicine, Affiliated Hospital of Jining Medical University, Jining, China.'}]",Pakistan journal of pharmaceutical sciences,[] 1506,31894037,Effects of Kuntai capsule on breast pain and vaginal bleeding in postmenopausal women.,"Aim of the present work was to investigate the clinical efficacy of Kuntai capsule in the treatment of postmenopausal women with endometriosis, Breast pain and Vaginal Bleeding. 120 elderly female outpatients over 50 years old with Breast pain were randomly divided into control group (60 cases) and observation group (60 cases). All patients were given diclofenac sodium enteric-coated tablets 25mg, 3 times a day. The observation group was given additional Kuntai capsules at a dose of 4 capsules per time, 3 times a day. Serum estradiol (E2), follicle stimulating hormone (FSH), and luteinizing hormone (LH) were detected in all patients before and at 12 weeks after treatment. Modified Kupperman score (K score) for evaluating menopausal symptoms. The post therapeutic serum follicle-stimulating hormone (FSH), luteinizing hormone (LH) and estradiol (E2) level and endometrial thickness decreased significantly (p<0.05). After treatment, KMI scores of kunati group was significantly decreased compared with baseline (<0.01) and there was no significant difference between groups (p>0.05). After treatment, hot flush and insomnia scores were both improved significantly. After therapy, serum E2 level obviously higher than the control groups, while FSH and LH levels were obviously lower (p<0.05). The incidence of vaginal bleeding, breast distending pain in group was obviously higher in control group than Kuntai group. Thus, Kuntai capsule improved the ovarian function of patients, raised the level of estrogen in vivo and alleviates the clinical manifestations of Breast pain.",2019,"The incidence of vaginal bleeding, breast distending pain in group was obviously higher in control group than Kuntai group.","['postmenopausal women with endometriosis, Breast pain and Vaginal Bleeding', '120 elderly female outpatients over 50 years old with Breast pain', 'postmenopausal women']","['Kuntai capsule', 'diclofenac sodium enteric-coated tablets']","['FSH and LH levels', 'KMI scores', 'serum E2 level', 'post therapeutic serum follicle-stimulating hormone (FSH), luteinizing hormone (LH) and estradiol (E2) level and endometrial thickness', 'Serum estradiol (E2), follicle stimulating hormone (FSH), and luteinizing hormone (LH', 'incidence of vaginal bleeding, breast distending pain', 'Modified Kupperman score (K score', 'breast pain and vaginal bleeding', 'hot flush and insomnia scores']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0014175', 'cui_str': 'Endometriosis'}, {'cui': 'C0024902', 'cui_str': 'Mammalgia'}, {'cui': 'C2979982', 'cui_str': 'Vaginal Bleeding'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C4507708', 'cui_str': 'kuntai capsule'}, {'cui': 'C0700583', 'cui_str': 'Diclofenac Sodium'}, {'cui': 'C0453946', 'cui_str': 'Coat (physical object)'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}]","[{'cui': 'C0733758', 'cui_str': 'Follicle Stimulating Hormone'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0857927', 'cui_str': 'Serum follicle stimulating hormone'}, {'cui': 'C0023607', 'cui_str': 'Luteinizing Hormone'}, {'cui': 'C1700235', 'cui_str': '(11BAPOP2) estradiol'}, {'cui': 'C0474672', 'cui_str': 'Serum estradiol measurement'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C2979982', 'cui_str': 'Vaginal Bleeding'}, {'cui': 'C0006141', 'cui_str': 'Breast'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0024902', 'cui_str': 'Mammalgia'}, {'cui': 'C0600142', 'cui_str': 'Hot Flashes'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}]",120.0,0.0189662,"The incidence of vaginal bleeding, breast distending pain in group was obviously higher in control group than Kuntai group.","[{'ForeName': 'Xiaoxia', 'Initials': 'X', 'LastName': 'Qi', 'Affiliation': 'Shandong Provincial Maternity & Child Care Hospital, Jinan, Shandong, PR China.'}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Guo', 'Affiliation': 'Shandong Provincial Maternity & Child Care Hospital, Jinan, Shandong, PR China.'}, {'ForeName': 'Lingna', 'Initials': 'L', 'LastName': 'Sun', 'Affiliation': 'Shandong Provincial Maternity & Child Care Hospital, Jinan, Shandong, PR China.'}]",Pakistan journal of pharmaceutical sciences,[] 1507,31894038,Clinical efficacy of nutrition support therapy combined with antibiotics in the patients of community-acquired pneumonia and its influence on serum pct and crp.,"To analyze the clinical efficacy of nutrition support therapy combined with antibiotics in the treatment of patients with ICU severe community-acquired pneumonia and its effect on serum procalcitonin (PCT) and C reactive protein (CRP). A total of 90 patients with ICU severe community-acquired pneumonia treated in hospital from September 2016 to June 2017.The patients were randomly divided into A group and B group 45 cases in each group. Both groups were given antibiotic treatment of azithromycin plus cefuroxime sodium in which the A group received enteral nutrition support therapy while the B group parenteral nutritional support therapy. Levels of serum prealbumin (PA), albumin (ALB), transferrin (TF), procalcitonin (PCT) and C reactive protein (CRP) before and after treatment were compared. Before treatment there was found no significant difference in serum PA, ALB and TF levels (p>0.05) while after treatment, the serum levels of PA, ALB and TF in the A group were significantly higher than those in the B group (p<0.05). The effective rate of the A group was 88.9%, higher than that of the B group (p<0.05). In patients with ICU severe community-acquired pneumonia, the treatment of enteral nutrition support therapy combined with antibacterial drugs of azithromycin and cefuroxime sodium can effectively improve the indexes of PA, ALB and TF. The reduce levels of serum PCT and CRP with the good prognosis is important in popularization and application in clinical practices.",2019,"Before treatment there was found no significant difference in serum PA, ALB and TF levels (p>0.05) while after treatment, the serum levels of PA, ALB and TF in the A group were significantly higher than those in the B group (p<0.05).","['patients with ICU severe community-acquired pneumonia', '90 patients with ICU severe community-acquired pneumonia treated in hospital from September 2016 to June', '2017.The patients']","['nutrition support therapy combined with antibiotics', 'azithromycin and cefuroxime sodium', 'azithromycin plus cefuroxime sodium', 'enteral nutrition support therapy']","['Levels of serum prealbumin (PA), albumin (ALB), transferrin (TF), procalcitonin (PCT) and C reactive protein (CRP', 'serum PA, ALB and TF levels', 'effective rate', 'serum procalcitonin (PCT) and C reactive protein (CRP', 'serum levels of PA, ALB and TF', 'indexes of PA, ALB and TF']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0694549', 'cui_str': 'Community acquired pneumonia (disorder)'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}]","[{'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C0701852', 'cui_str': 'Cefuroxime sodium'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0086225', 'cui_str': 'Enteral Feeding'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0032923', 'cui_str': 'Transthyretin'}, {'cui': 'C3711292', 'cui_str': '68Ga-albumin'}, {'cui': 'C0040679', 'cui_str': 'beta-1 Metal-Binding Globulin'}, {'cui': 'C1535922', 'cui_str': 'Procalcitonin'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0912730', 'cui_str': 'aluminum boride'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",90.0,0.0128577,"Before treatment there was found no significant difference in serum PA, ALB and TF levels (p>0.05) while after treatment, the serum levels of PA, ALB and TF in the A group were significantly higher than those in the B group (p<0.05).","[{'ForeName': 'Qianqian', 'Initials': 'Q', 'LastName': 'Zhou', 'Affiliation': 'Gansu Provincial Hospital, Intensive Care Unit, Lanzhou, Gansu, PR China.'}, {'ForeName': 'Liqin', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Gansu Provincial Hospital, Intensive Care Unit, Lanzhou, Gansu, PR China.'}, {'ForeName': 'Xiandong', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Gansu Provincial Hospital, Intensive Care Unit, Lanzhou, Gansu, PR China.'}, {'ForeName': 'Quanhong', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': 'Gansu Provincial Hospital, Intensive Care Unit, Lanzhou, Gansu, PR China.'}, {'ForeName': 'Dongquan', 'Initials': 'D', 'LastName': 'Zhang', 'Affiliation': 'Gansu Provincial Hospital, Intensive Care Unit, Lanzhou, Gansu, PR China.'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Yuan', 'Affiliation': 'Gansu Provincial Hospital, Intensive Care Unit, Lanzhou, Gansu, PR China.'}]",Pakistan journal of pharmaceutical sciences,[] 1508,31894027,Clinical effect and safety of nifedipine controlled-release tablets combined with valsartan in the treatment of primary hypertension.,"To observe and analyze the clinical effect of nifedipine controlled-release tablets combined with valsartan in the treatment of essential hypertension, and to analyze the adverse reactions of patients. A total of 180 patients with primary hypertension treated in our hospital were enrolled as research objects in the study. According to different treatment regimens, they were divided into the control group treated with valsartan dispersible tablets and the research group treated with nifedipine controlled-release tablets combined with valsartan. The therapeutic effects of the two groups of patients were compared and analyzed. Compared with the control group (82.22%), the total treatment effective rate of the research group (95.56%) was higher, p<0.05. Comparing the blood pressure level before and after treatment of the two groups, the improvement effect of the research group after treatment was more obvious, p<0.05. The incidence of adverse reactions was 6.67% in the research group, which was significantly lower than that (20.00%) in the control group, p<0.05. The application of nifedipine controlled-release tablets combined with valsartan in the treatment of patients with primary hypertension can significantly improve the therapeutic effect of patients, and has good safety and reliability, which is a treatment mode worthy of promotion and practice.",2019,"Compared with the control group (82.22%), the total treatment effective rate of the research group (95.56%) was higher, p<0.05.","['patients with primary hypertension', '180 patients with primary hypertension treated in our hospital were enrolled as research objects in the study', 'patients', 'primary hypertension']","['valsartan', 'nifedipine', 'nifedipine controlled-release tablets combined with valsartan', 'valsartan dispersible tablets']","['therapeutic effects', 'total treatment effective rate', 'incidence of adverse reactions', 'blood pressure level']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0085580', 'cui_str': 'Essential Hypertension'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0347997', 'cui_str': 'Physical object'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0216784', 'cui_str': 'valsartan'}, {'cui': 'C0028066', 'cui_str': 'Nifedipine'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}, {'cui': 'C0336789', 'cui_str': 'Combine'}]","[{'cui': 'C1527144'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction (disorder)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",180.0,0.0174346,"Compared with the control group (82.22%), the total treatment effective rate of the research group (95.56%) was higher, p<0.05.","[{'ForeName': 'Wenhui', 'Initials': 'W', 'LastName': 'Liu', 'Affiliation': 'Department of Medicine, Hetao College, Bayannur, China.'}, {'ForeName': 'Yanyang', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Cardiology, The Affiliated Hospital of Inner Mongolia Medical University, Hohhot, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Fu', 'Affiliation': 'Department of Medicine, Hetao College, Bayannur, China.'}]",Pakistan journal of pharmaceutical sciences,[] 1509,31894028,Analysis of comparative anesthetic effects of sevoflurane and propofol on lung and cognitive functions.,"This study was designed to compare the effects of TIVA (total intravenous anesthesia) by propofol and sevoflurane inhalation on perioperative inflammatory response, pulmonary function and postoperative cognitive function in patients with lung cancer resection. A total of 98 patients were randomly divided into study and control group with 49 cases in each group. The study group was given total intravenous anesthesia with propofol while the control group underwent simple inhalation anesthesia with sevoflurane. A-aDO2 (Alveolar-arterial oxygen partial pressure difference), RI (respiratory index), Qs/Qt (intrapulmonary shunt), MMP-9 (serum matrix metalloproteinase-9) and MDA (malondialdehyde) concentrations were compared between the two groups respectively at T0 (immediately before anesthesia induction), T1 (immediately at the beginning of OLV), T2 (immediately at the end of OLV), T3 (immediately before, immediately after closure of thoracic incision) and T4 (24h after operation). The MMSE score of two groups were compared before operation at 6, 24, 72 h and 7 d after operation. The A-aDO2, RI and Qs/Qt of two groups were significantly higher at T3 -T4 than at T0 and T3 the concentrations of MMP-9 and MDA were markedly increased. Compared with the control group, the concentrations of A-aDO2, MMP-9 and MDA at T3, the RI at T2-T3 and the Qs/Qt at T1-T3 all were lower in the study group. The MMSE (Mini Mental State Scale) score of the control group was higher than study group at 24 and 72 h after operation. The anesthesia with propofol can significantly reduce the perioperative inflammatory response and peroxidation with fewer damages on lung function.",2019,"Compared with the control group, the concentrations of A-aDO2, MMP-9 and MDA at T3, the RI at T2-T3 and the Qs/Qt at T1-T3 all were lower in the study group.","['patients with lung cancer resection', '98 patients']","['total intravenous anesthesia with propofol', 'sevoflurane and propofol', 'aDO2', 'sevoflurane', 'propofol and sevoflurane inhalation', 'TIVA (total intravenous anesthesia', 'propofol']","['perioperative inflammatory response and peroxidation', 'concentrations of MMP-9 and MDA', 'Alveolar-arterial oxygen partial pressure difference), RI (respiratory index), Qs/Qt (intrapulmonary shunt), MMP-9 (serum matrix metalloproteinase-9) and MDA (malondialdehyde) concentrations', 'MMSE (Mini Mental State Scale) score', 'perioperative inflammatory response, pulmonary function and postoperative cognitive function', 'lung and cognitive functions', 'MMSE score', 'concentrations of A-aDO2, MMP-9 and MDA']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1306460', 'cui_str': 'Primary malignant neoplasm of lung'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}]","[{'cui': 'C0473965', 'cui_str': 'Total intravenous anesthesia (procedure)'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C1705211', 'cui_str': 'Inhalation - unit of product usage'}, {'cui': 'C3854651', 'cui_str': 'TIVA'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0623362', 'cui_str': 'MMPs'}, {'cui': 'C0000379', 'cui_str': '1,3-Benzodioxole-5-ethanamine, alpha-methyl-'}, {'cui': 'C0221464', 'cui_str': 'Arterial (qualifier value)'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0030604', 'cui_str': 'Partial Pressure'}, {'cui': 'C0451423', 'cui_str': 'Respiratory index (assessment scale)'}, {'cui': 'C0489642', 'cui_str': 'Intrapulmonary shunt'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0165519', 'cui_str': '92-kDa Type IV Collagenase'}, {'cui': 'C0451306', 'cui_str': 'Folstein Mini-Mental State Examination'}, {'cui': 'C0445542', 'cui_str': 'Mini (qualifier value)'}, {'cui': 'C0278060', 'cui_str': 'Mental status'}, {'cui': 'C0222045'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}, {'cui': 'C0024109', 'cui_str': 'Lung'}]",98.0,0.0127143,"Compared with the control group, the concentrations of A-aDO2, MMP-9 and MDA at T3, the RI at T2-T3 and the Qs/Qt at T1-T3 all were lower in the study group.","[{'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Zhiguo', 'Affiliation': ""Department of Anesthesiology, Jiangsu Taizhou People's Hospital, Taizhou, Jiangsu, PR China.""}, {'ForeName': 'Zhou', 'Initials': 'Z', 'LastName': 'Nanxiang', 'Affiliation': ""Department of Rehabilitation, Jiangsu Taizhou People's Hospital, Taizhou, Jiangsu, PR China.""}, {'ForeName': 'Man', 'Initials': 'M', 'LastName': 'Jinyu', 'Affiliation': ""Department of Anesthesiology, Jiangsu Taizhou People's Hospital, Taizhou, Jiangsu, PR China.""}]",Pakistan journal of pharmaceutical sciences,[] 1510,31894029,Efficacy and safety of NAD+ ADP-ribosyltransferase 1 agonist versus Donepezil in elderly Chinese patients with Alzheimer disease: A novel target for effective therapy.,"This pilot study designed to evaluate the efficacy and safety of NAD+ ADP-ribosyl transferase 1 (NART) agonist in comparison with Donepezil (DNP) in elderly Chinese patients with Alzheimer disease (AD). In the present clinical trial, Chinese elderly patients aged >65 years with a confirmed diagnosis of AD were enrolled. The patients received NART agonist (test, DAG-structured PKC blockers (GF109203X)) or DNP 10mg daily (reference) for 6 months. The efficacy and safety data were collected from 120 patients (60 patients in each group) every 3 weeks until 6 months. The primary endpoints were to assess the change in cognitive score from baseline in both the treatment group. The result of the present study showed that the patients treated with DNP and NART agonist have similar efficacy and safety profile. Considering the clinical benefit, improvement in sign and symptoms of was numerically greater in DNP-treated patients as compared to NART agonist. However, a statistical difference in terms of clinical benefit was similar between both the treatment groups. Overall, both the study drugs were found comparable in relieving the symptoms of AD. This indicates that NART is a potential target for the treatment of AD in China. The results of the present study may help to design a large clinical trial to evaluate the efficacy and safety of NART agonist in comparison with DNP in AD patients.",2019,"However, a statistical difference in terms of clinical benefit was similar between both the treatment groups.","['Chinese elderly patients aged >65 years with a confirmed diagnosis of AD were enrolled', 'elderly Chinese patients with Alzheimer disease', 'elderly Chinese patients with Alzheimer disease (AD', 'AD patients', '120 patients (60 patients in each group) every 3 weeks until 6 months']","['ADP-ribosyl transferase 1 (NART) agonist', 'NAD+ ADP-ribosyltransferase 1 agonist versus Donepezil', 'DNP and NART agonist', 'NART', 'Donepezil (DNP', 'NART agonist', 'NAD', 'NART agonist (test, DAG-structured PKC blockers (GF109203X)) or DNP']","['change in cognitive score', 'clinical benefit', 'efficacy and safety', 'efficacy and safety data']","[{'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0002395', 'cui_str': 'Alzheimer Dementia'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C0001459', 'cui_str': ""Adenosine 5'-Pyrophosphate""}, {'cui': 'C0040676', 'cui_str': 'Transferase'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C4082864', 'cui_str': 'NAD+ ADP-ribosyltransferase-1'}, {'cui': 'C0527316', 'cui_str': 'donepezil'}, {'cui': 'C0621630', 'cui_str': 'NAD(S)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0256015', 'cui_str': 'PRKCG'}]","[{'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",120.0,0.0378814,"However, a statistical difference in terms of clinical benefit was similar between both the treatment groups.","[{'ForeName': 'Jianhong', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': ""Department of Neurology, Sichuan Provincial People's Hospital, University of Electronic Science and Technology of China, Chengdu, China.""}, {'ForeName': 'Shu', 'Initials': 'S', 'LastName': 'Yang', 'Affiliation': ""Department of Neurology, Sichuan Provincial People's Hospital, University of Electronic Science and Technology of China, Chengdu, China.""}, {'ForeName': 'Zicheng', 'Initials': 'Z', 'LastName': 'Hu', 'Affiliation': 'Department of Neurology, Daping Hospital, Third Military Medical University, Chongqing, China.'}, {'ForeName': 'Haimei', 'Initials': 'H', 'LastName': 'Yang', 'Affiliation': 'Department of Neurology, Daping Hospital, Third Military Medical University, Chongqing, China.'}, {'ForeName': 'Dong', 'Initials': 'D', 'LastName': 'Wei', 'Affiliation': ""Department of Neurology, The People's Hospital of Lezhi, Ziyang, Sichuan, China.""}, {'ForeName': 'Duozi', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': ""Department of Neurology, Sichuan Provincial People's Hospital, University of Electronic Science and Technology of China, Chengdu, China.""}, {'ForeName': 'Fuqiang', 'Initials': 'F', 'LastName': 'Guo', 'Affiliation': ""Department of Neurology, Sichuan Provincial People's Hospital, University of Electronic Science and Technology of China, Chengdu, China.""}]",Pakistan journal of pharmaceutical sciences,[] 1511,31490251,Quality of Recovery After Breast Surgery: A Multicenter Randomized Clinical Trial Comparing Pectoral Nerves Interfascial Plane (Pectoral Nerves II) Block With Surgical Infiltration.,"BACKGROUND Pectoral nerves (PECS II) block is a popular regional analgesia technique for breast surgery. PECS II block or local infiltration by surgeon may improve outcomes including quality of recovery (QoR). METHODS In this multicenter randomized clinical trial, 104 female patients undergoing breast surgery received: (1) PECS II block with local anesthetic and surgical infiltration with 0.9% saline (PECS group) or (2) PECS II block with 0.9% saline and surgical infiltration with local anesthetic (infiltration group). Patients, anesthetists, surgeons, nursing staff, and research assistants were blinded to group allocation. Patients received standardized general anesthesia and multimodal analgesia. The primary outcome was the global score (maximum score, 150; good recovery, 118) of the multidimensional (pain, comfort, independence, psychological, emotional) QoR-15 questionnaire measured 24 hours postoperatively. Secondary outcomes were pain, and its functional interference measured 24 hours and 3 months postoperatively using the Brief Pain Inventory (BPI) short form (0, optimal; 120, worst possible). Randomly assigned groups were compared on outcomes using the Wilcoxon rank-sum test, and the results were reported as median difference with 95% confidence interval. RESULTS One hundred eight patients were recruited from August 17, 2016 to June 8, 2018, and 4 patients were withdrawn. Twelve patients from 104 had mastectomy, with the remainder having less invasive surgery. Baseline QoR-15 global scores reported as median [quartiles] were 135 [129, 143] in the PECS group and 139 [127, 143] in the infiltration group. The 24-hour QoR-15 global score reported as median [quartiles] was 131 [116, 140] in the PECS group and 123 [117, 143] in the infiltration group (P = .60), with median difference (95% confidence interval) of -2 (-9 to 5). The median difference reported as infiltration minus PECS for QoR-15 domains was pain 0 (-2 to 1), physical comfort -1 (-3 to 2), physical independence 0 (-2 to 1), psychological support 0 (0-0), and emotions 0 (-1 to 2) (P > .28). The BPI pain subscale at 24 hours (0-40, lower score indicates less pain), reported as median [quartiles], was 7 [2, 13] in the PECS group and 10 [5, 17] in the infiltration group (P = .15). The BPI global score at 24 hours, reported as median [quartiles], was 20 [7, 36] in the PECS group and 23 [10, 43] in the infiltration group (P = .34) and at 3 months was 0 [0, 14] and 0 [0, 11] (P = .85). CONCLUSIONS After mostly minor surgery for breast cancer, PECS II block was not superior to local infiltration by the surgeon.",2020,"The primary outcome was the global score (maximum score, 150; good recovery, 118) of the multidimensional (pain, comfort, independence, psychological, emotional)","['After Breast Surgery', '104 female patients undergoing breast surgery received: (1', 'One hundred eight patients were recruited from August 17, 2016 to June 8, 2018, and 4 patients were withdrawn', 'Twelve patients from 104 had mastectomy, with the remainder having less invasive surgery']","['Pectoral nerves (PECS II) block', 'PECS II block with local anesthetic and surgical infiltration with 0.9% saline (PECS group) or (2) PECS II block with 0.9% saline and surgical infiltration with local anesthetic (infiltration group', 'standardized general anesthesia and multimodal analgesia', 'PECS', 'Pectoral Nerves Interfascial Plane (Pectoral Nerves II']","['QoR-15 questionnaire', 'global score (maximum score, 150; good recovery, 118) of the multidimensional (pain, comfort, independence, psychological, emotional', 'BPI pain subscale', 'pain', 'quality of recovery (QoR', 'physical comfort -1 (-3 to 2), physical independence 0', 'pain, and its functional interference measured 24 hours and 3 months postoperatively using the Brief Pain Inventory (BPI) short form (0, optimal; 120, worst possible', 'Baseline QoR-15 global scores', 'Quality of Recovery', '24-hour QoR-15 global score', 'BPI global score']","[{'cui': 'C0851312', 'cui_str': 'Breast surgery'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0424092', 'cui_str': 'Withdrawn (finding)'}, {'cui': 'C0024886', 'cui_str': 'Total Mastectomy'}, {'cui': 'C0205281', 'cui_str': 'Invasive (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]","[{'cui': 'C0205967', 'cui_str': 'Pectoral Nerves'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C4273496', 'cui_str': 'Modified PECS block'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia (procedure)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C3669041', 'cui_str': 'Spread by direct extension (qualifier value)'}, {'cui': 'C0445115', 'cui_str': '0.9% NaCl'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0002915', 'cui_str': 'General Anesthesia'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0444660', 'cui_str': 'Plane (attribute)'}]","[{'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C4517542', 'cui_str': '118'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C4319550', 'cui_str': '120 (qualifier value)'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0332149', 'cui_str': 'Possible (qualifier value)'}]",104.0,0.164772,"The primary outcome was the global score (maximum score, 150; good recovery, 118) of the multidimensional (pain, comfort, independence, psychological, emotional)","[{'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Barrington', 'Affiliation': ""From the Department of Anaesthesia and Acute Pain Medicine, St Vincent's Hospital, Melbourne, Victoria, Australia.""}, {'ForeName': 'Gloria J', 'Initials': 'GJ', 'LastName': 'Seah', 'Affiliation': ""From the Department of Anaesthesia and Acute Pain Medicine, St Vincent's Hospital, Melbourne, Victoria, Australia.""}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Gotmaker', 'Affiliation': ""From the Department of Anaesthesia and Acute Pain Medicine, St Vincent's Hospital, Melbourne, Victoria, Australia.""}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Lim', 'Affiliation': ""Pharmacy, St Vincent's Hospital, Melbourne, Victoria, Australia.""}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Byrne', 'Affiliation': 'Department of Anaesthesia, Waikato Hospital, Hamilton, New Zealand.'}]",Anesthesia and analgesia,['10.1213/ANE.0000000000004371'] 1512,31951148,[Dental anxiety in preschool children: How helpful are behavioral control management strategies?],"Dental anxiety in preschool children: How helpful are behavioral control management strategies? Abstract. Objective: Dental anxiety is a frequent problem in the dental treatment of young children. Control management methods are widely used in pediatric dental care as coping strategies. This study compares two control management strategies regarding their reduction of dental anxiety and treatment success. Method: A group of 60 preschool children with known dental fear in their medical history underwent professional dental cleaning in which the Tell-Show-Do Method (TSDM) was applied. Patients were randomized into two groups according to the controlling method employed: (1) limited controlling method (L-K) and (2) standardized controlling method (S-K). The efficacy of the two control methods was tested using pulse rate as an objective measure of anxiety and self-rating as a subjective indicator. Results: Both the S-K and the L-K condition showed a significant reduction in pulse rate, and there was no difference in physiological arousal and treatment success. However, independent of the group disposition, there was a noticeable increase in pulse rate in children after TSDM. Conclusion: The results of this study indicate that even limited options for controlling dental treatment do not lead to greater burdens on the children in question with dental anxiety. However, further studies are necessary to investigate the use of control methods independent of TSDM.",2020,"Both the S-K and the L-K condition showed a significant reduction in pulse rate, and there was no difference in physiological arousal and treatment success.","['60 preschool children with known dental fear in their medical history', 'young children', 'preschool children']",['professional dental cleaning in which the Tell-Show-Do Method (TSDM'],"['Dental anxiety', 'pulse rate', 'physiological arousal and treatment success']","[{'cui': 'C0008100', 'cui_str': 'Child, Preschool'}, {'cui': 'C0205309', 'cui_str': 'Known (qualifier value)'}, {'cui': 'C0085380', 'cui_str': 'Fear, Dental'}, {'cui': 'C0019665', 'cui_str': 'historical aspects'}, {'cui': 'C0337547', 'cui_str': 'Younger child (person)'}]","[{'cui': 'C4522313', 'cui_str': 'Dental (intended site)'}, {'cui': 'C0402683', 'cui_str': 'Cleaner'}, {'cui': 'C0025663', 'cui_str': 'Methods'}]","[{'cui': 'C0085380', 'cui_str': 'Fear, Dental'}, {'cui': 'C0232117', 'cui_str': 'Pulse Rate'}, {'cui': 'C0205463', 'cui_str': 'Physiologic (qualifier value)'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]",,0.0203604,"Both the S-K and the L-K condition showed a significant reduction in pulse rate, and there was no difference in physiological arousal and treatment success.","[{'ForeName': 'Dagmar', 'Initials': 'D', 'LastName': 'Pfau', 'Affiliation': 'Kinder- und Jugendpsychiatrie, Basel, Schweiz.'}, {'ForeName': 'Eirini', 'Initials': 'E', 'LastName': 'Stratigaki', 'Affiliation': 'Kinderzahnmedizin, Adligenswil, Schweiz.'}, {'ForeName': 'Carlaalberta', 'Initials': 'C', 'LastName': 'Verna', 'Affiliation': 'Klinik für Kieferorthopädie und Kinderzahnmedizin, Basel, Schweiz.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Stadler', 'Affiliation': 'Kinder- und Jugendpsychiatrie, Basel, Schweiz.'}]",Zeitschrift fur Kinder- und Jugendpsychiatrie und Psychotherapie,['10.1024/1422-4917/a000703'] 1513,10626570,Effect of iodine supply on neonatal thyroid volume and TSH.,"A cross-sectional study was performed to prove the correlation between iodine intake and neonatal thyroid volume in a randomized group of 100 mother/newborn pairs. Thyroid volume and iodine excretion were measured by ultrasound and urinary iodine excretion, respectively. Iodine intake and, nutritional and smoking habits were estimated by questionnaire. In 89 mother/child-pairs the data were complete for all parameters and have been analyzed: 32 mothers substituted with iodine tablets, average dose 175 microg K-Iodide/day. Iodine excretion of prenatally iodine-substituted newborns increased by 62% whereas neonatal thyroid volume was reduced by 18% compared with the non-iodine-supplemented group. Smoker's newborns (n = 8) had a thyroid volume 20% larger than that of newborns of non-smokers. Neonatal TSH-screening values remained within normal limits.",1999,Iodine excretion of prenatally iodine-substituted newborns increased by 62% whereas neonatal thyroid volume was reduced by 18% compared with the non-iodine-supplemented group.,"['100 mother/newborn pairs', ""Smoker's newborns (n = 8) had a thyroid volume 20% larger than that of newborns of non-smokers""]","['iodine supply', 'iodine tablets']","['iodine intake and neonatal thyroid volume', 'Iodine excretion', 'neonatal thyroid volume', 'Iodine intake and, nutritional and smoking habits', 'neonatal thyroid volume and TSH', 'Neonatal TSH-screening values', 'Thyroid volume and iodine excretion']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0040134', 'cui_str': 'thyroid (USP)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C4554605', 'cui_str': 'Nonsmokers'}]","[{'cui': 'C0021968', 'cui_str': 'molecular iodine'}, {'cui': 'C1875802', 'cui_str': 'Healthcare supplies'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}]","[{'cui': 'C0021968', 'cui_str': 'molecular iodine'}, {'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}, {'cui': 'C0040134', 'cui_str': 'thyroid (USP)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0221102', 'cui_str': 'Excretory function (observable entity)'}, {'cui': 'C4505437', 'cui_str': 'Smoking Habit'}, {'cui': 'C0202230', 'cui_str': 'Thyroid stimulating hormone measurement (procedure)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",,0.0117333,Iodine excretion of prenatally iodine-substituted newborns increased by 62% whereas neonatal thyroid volume was reduced by 18% compared with the non-iodine-supplemented group.,"[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Klett', 'Affiliation': ""University Children's Hospital, Hormonlabor, Heidelberg, Germany.""}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Ohlig', 'Affiliation': ''}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Manz', 'Affiliation': ''}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Tröger', 'Affiliation': ''}, {'ForeName': 'U', 'Initials': 'U', 'LastName': 'Heinrich', 'Affiliation': ''}]","Acta paediatrica (Oslo, Norway : 1992). Supplement",[] 1514,31416768,"Live-attenuated Mycobacterium tuberculosis vaccine MTBVAC versus BCG in adults and neonates: a randomised controlled, double-blind dose-escalation trial.","BACKGROUND Infants are a key target population for new tuberculosis vaccines. We assessed the safety and immunogenicity of the live-attenuated Mycobacterium tuberculosis vaccine candidate MTBVAC in adults and infants in a region where transmission of tuberculosis is very high. METHODS We did a randomised, double-blind, BCG-controlled, dose-escalation trial at the South African Tuberculosis Vaccine Initiative site near Cape Town, South Africa. Healthy adult community volunteers who were aged 18-50 years, had received BCG vaccination as infants, were HIV negative, had negative interferon-γ release assay (IGRA) results, and had no personal history of tuberculosis or current household contact with someone with tuberculosis were enrolled in a safety cohort. Infants born to HIV-negative women with no personal history of tuberculosis or current household contact with a person with tuberculosis and who were 96 h old or younger, generally healthy, and had not yet received routine BCG vaccination were enrolled in a separate infant cohort. Eligible adults were randomly assigned (1:1) to receive either BCG Vaccine SSI (5 × 10 5 colony forming units [CFU] of Danish strain 1331 in 0·1 mL diluent) or MTBVAC (5 × 10 5 CFU in 0·1 mL) intradermally in the deltoid region of the arm. After favourable review of 28-day reactogenicity and safety data in the adult cohort, infants were randomly assigned (1:3) to receive either BCG Vaccine SSI (2·5 × 10 5 CFU in 0·05 mL diluent) or MTBVAC in three sequential cohorts of increasing MTBVAC dose (2·5 × 10 3 CFU, 2·5 × 10 4 CFU, and 2·5 × 10 5 CFU in 0·05 mL) intradermally in the deltoid region of the arm. QuantiFERON-TB Gold In-Tube IGRA was done on days 180 and 360. For both randomisations, a pre-prepared block randomisation schedule was used. Participants (and their parents or guardians in the case of infant participants), investigators, and other clinical and laboratory staff were masked to intervention allocation. The primary outcomes, which were all measured in the infant cohort, were solicited and unsolicited local adverse events and serious adverse events until day 360; non-serious systemic adverse events until day 28 and vaccine-specific CD4 and CD8 T-cell responses on days 7, 28, 70, 180, and 360. Secondary outcomes measured in adults were local injection-site and systemic reactions and haematology and biochemistry at study day 7 and 28. Safety analyses and immunogenicity analyses were done in all participants who received a dose of vaccine. This trial is registered with ClinicalTrials.gov, number NCT02729571. FINDINGS Between Sept 29, 2015, and Nov 16, 2015, 62 adults were screened and 18 were enrolled and randomly assigned, nine each to the BCG and MTBVAC groups. Between Feb 12, 2016, and Sept 21, 2016, 36 infants were randomly assigned-eight to the BCG group, nine to the 2·5 × 10 3 CFU MTBVAC group, nine to the 2·5 × 10 4 CFU group, and ten to the 2·5 × 10 5 CFU group. Mild injection-site reactions occurred only in infants in the BCG and the 2·5 × 10 5 CFU MTBVAC group, with no evidence of local or regional injection-site complications. Systemic adverse events were evenly distributed across BCG and MTBVAC dose groups, and were mostly mild in severity. Eight serious adverse events were reported in seven vaccine recipients (one adult MTBVAC recipient, one infant BCG recipient, one infant in the 2·5 × 10 3 CFU MTBVAC group, two in the 2·5 × 10 4 CFU MTBVAC group, and two in the 2·5 × 10 5 CFU MTBVAC group), including one infant in the 2·5 × 10 3 CFU MTBVAC group treated for unconfirmed tuberculosis and one in the 2·5 × 10 5 CFU MTBVAC group treated for unlikely tuberculosis. One infant died as a result of possible viral pneumonia. Vaccination with all MTBVAC doses induced durable antigen-specific T-helper-1 cytokine-expressing CD4 cell responses in infants that peaked 70 days after vaccination and were detectable 360 days after vaccination. For the highest MTBVAC dose (ie, 2·5 × 10 5 CFU), these responses exceeded responses induced by an equivalent dose of the BCG vaccine up to 360 days after vaccination. Dose-related IGRA conversion was noted in three (38%) of eight infants in the 2·5 × 10 3 CFU MTBVAC group, six (75%) of eight in the 2·5 × 10 4 CFU MTBVAC group, and seven (78%) of nine in the 2·5 × 10 5 CFU MTBVAC group at day 180, compared with none of seven infants in the BCG group. By day 360, IGRA reversion had occurred in all three infants (100%) in the 2·5 × 10 3 CFU MTBVAC group, four (67%) of the six in the 2·5 × 10 4 CFU MTBVAC group, and three (43%) of the seven in the 2·5 × 10 5 CFU MTBVAC group. INTERPRETATION MTBVAC had acceptable reactogenicity, and induced a durable CD4 cell response in infants. The evidence of immunogenicity supports progression of MTBVAC into larger safety and efficacy trials, but also confounds interpretation of tests for M tuberculosis infection, highlighting the need for stringent endpoint definition. FUNDING Norwegian Agency for Development Cooperation, TuBerculosis Vaccine Initiative, UK Department for International Development, and Biofabri.",2019,"Mild injection-site reactions occurred only in infants in the BCG and the 2·5 × 10 5 CFU MTBVAC group, with no evidence of local or regional injection-site complications.","['Between Sept 29, 2015, and Nov 16, 2015, 62 adults were screened and 18', 'Infants born to HIV-negative women with no personal history of tuberculosis or current household contact with a person with tuberculosis and who were 96 h old or younger, generally healthy, and had not yet received routine BCG vaccination were enrolled in a separate infant cohort', 'Participants (and their parents or guardians in the case of infant participants), investigators, and other clinical and laboratory staff were masked to intervention allocation', 'Between Feb 12, 2016, and Sept 21, 2016, 36 infants', 'adults and infants in a region where transmission of tuberculosis is very high', 'adult cohort, infants', 'adults and neonates', 'Eligible adults', 'Healthy adult community volunteers who were aged 18-50 years, had received BCG vaccination as infants, were HIV negative, had negative interferon-γ release assay (IGRA) results, and had no personal history of tuberculosis or current household contact with someone with tuberculosis were enrolled in a safety cohort', 'South African Tuberculosis Vaccine Initiative site near Cape Town, South Africa']","['Live-attenuated Mycobacterium tuberculosis vaccine MTBVAC versus BCG', 'vaccine', 'QuantiFERON-TB Gold', 'BCG', 'BCG vaccine', 'live-attenuated Mycobacterium tuberculosis vaccine candidate MTBVAC', 'BCG Vaccine SSI (2·5\u2008×\u200810 5 CFU in 0·05 mL diluent) or MTBVAC', 'BCG Vaccine SSI (5\u2008×\u200810 5 colony forming units [CFU] of Danish strain 1331 in 0·1 mL diluent) or MTBVAC ']","['durable CD4 cell response', 'local injection-site and systemic reactions and haematology and biochemistry', 'IGRA conversion', 'solicited and unsolicited local adverse events and serious adverse events until day 360; non-serious systemic adverse events until day 28 and vaccine-specific CD4 and CD8 T-cell responses', 'IGRA reversion', 'safety and immunogenicity', 'Systemic adverse events', 'durable antigen-specific T-helper-1 cytokine-expressing CD4 cell responses', 'Mild injection-site reactions']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0481430', 'cui_str': 'HTLV-3 antibody negative'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0424945', 'cui_str': 'Social / personal history observable'}, {'cui': 'C0041296', 'cui_str': 'Mycobacterium tuberculosis Infection'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0332158', 'cui_str': 'Contact with (contextual qualifier) (qualifier value)'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0199804', 'cui_str': 'BCG immunization'}, {'cui': 'C0443299', 'cui_str': 'Separate (qualifier value)'}, {'cui': 'C0035173', 'cui_str': 'Investigators'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C2700616', 'cui_str': 'Manpowers'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0040722', 'cui_str': 'transmission'}, {'cui': 'C0442804', 'cui_str': 'Very high (qualifier value)'}, {'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0021747', 'cui_str': 'Interferons'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C1510438', 'cui_str': 'Assay technique (qualifier value)'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0041305', 'cui_str': 'Tuberculosis Vaccines'}, {'cui': 'C0424093', 'cui_str': 'Initiative (observable entity)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0475806', 'cui_str': 'Nr - Near'}, {'cui': 'C0453952', 'cui_str': 'Cape (physical object)'}, {'cui': 'C0557750', 'cui_str': 'Towns'}, {'cui': 'C0037712', 'cui_str': 'Union of South Africa'}]","[{'cui': 'C0332161', 'cui_str': 'Attenuated by (contextual qualifier) (qualifier value)'}, {'cui': 'C0026926', 'cui_str': 'Mycobacterium tuberculosis'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0085957', 'cui_str': 'BCG'}, {'cui': 'C0018026', 'cui_str': 'Gold'}, {'cui': 'C0004886', 'cui_str': 'BCG Vaccine'}, {'cui': 'C0553561', 'cui_str': 'colony-forming unit (qualifier value)'}, {'cui': 'C0080194', 'cui_str': 'Strains'}]","[{'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0221208', 'cui_str': 'Injection site (morphologic abnormality)'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0443286', 'cui_str': 'Reaction (qualifier value)'}, {'cui': 'C1274119', 'cui_str': 'Haematology (specialty)'}, {'cui': 'C0005477', 'cui_str': 'Biochemistry'}, {'cui': 'C0439836', 'cui_str': 'Conversions (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C4319607', 'cui_str': '360 (qualifier value)'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0039194', 'cui_str': 'Thymus-Dependent Lymphocytes'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0003320', 'cui_str': 'Antigens'}, {'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0151735', 'cui_str': 'Injection Site Adverse Event'}]",62.0,0.353474,"Mild injection-site reactions occurred only in infants in the BCG and the 2·5 × 10 5 CFU MTBVAC group, with no evidence of local or regional injection-site complications.","[{'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Tameris', 'Affiliation': 'South African Tuberculosis Vaccine Initiative, Institute of Infectious Disease and Molecular Medicine and Division of Immunology, Department of Pathology, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Mearns', 'Affiliation': 'South African Tuberculosis Vaccine Initiative, Institute of Infectious Disease and Molecular Medicine and Division of Immunology, Department of Pathology, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Penn-Nicholson', 'Affiliation': 'South African Tuberculosis Vaccine Initiative, Institute of Infectious Disease and Molecular Medicine and Division of Immunology, Department of Pathology, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Yolande', 'Initials': 'Y', 'LastName': 'Gregg', 'Affiliation': 'South African Tuberculosis Vaccine Initiative, Institute of Infectious Disease and Molecular Medicine and Division of Immunology, Department of Pathology, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Bilek', 'Affiliation': 'South African Tuberculosis Vaccine Initiative, Institute of Infectious Disease and Molecular Medicine and Division of Immunology, Department of Pathology, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Simbarashe', 'Initials': 'S', 'LastName': 'Mabwe', 'Affiliation': 'South African Tuberculosis Vaccine Initiative, Institute of Infectious Disease and Molecular Medicine and Division of Immunology, Department of Pathology, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Hennie', 'Initials': 'H', 'LastName': 'Geldenhuys', 'Affiliation': 'South African Tuberculosis Vaccine Initiative, Institute of Infectious Disease and Molecular Medicine and Division of Immunology, Department of Pathology, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Shenje', 'Affiliation': 'South African Tuberculosis Vaccine Initiative, Institute of Infectious Disease and Molecular Medicine and Division of Immunology, Department of Pathology, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Angelique Kany Kany', 'Initials': 'AKK', 'LastName': 'Luabeya', 'Affiliation': 'South African Tuberculosis Vaccine Initiative, Institute of Infectious Disease and Molecular Medicine and Division of Immunology, Department of Pathology, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Ingrid', 'Initials': 'I', 'LastName': 'Murillo', 'Affiliation': 'Biofabri, Pontevedra, Spain.'}, {'ForeName': 'Juana', 'Initials': 'J', 'LastName': 'Doce', 'Affiliation': 'Biofabri, Pontevedra, Spain.'}, {'ForeName': 'Nacho', 'Initials': 'N', 'LastName': 'Aguilo', 'Affiliation': 'Department of Microbiology, Faculty of Medicine, University of Zaragoza, Zaragoza, Spain; CIBERES and Research Network on Respiratory Diseases, Spanish Ministry of Health and Instituto de Salud Carlos III, Madrid, Spain.'}, {'ForeName': 'Dessislava', 'Initials': 'D', 'LastName': 'Marinova', 'Affiliation': 'Department of Microbiology, Faculty of Medicine, University of Zaragoza, Zaragoza, Spain; CIBERES and Research Network on Respiratory Diseases, Spanish Ministry of Health and Instituto de Salud Carlos III, Madrid, Spain.'}, {'ForeName': 'Eugenia', 'Initials': 'E', 'LastName': 'Puentes', 'Affiliation': 'Biofabri, Pontevedra, Spain.'}, {'ForeName': 'Esteban', 'Initials': 'E', 'LastName': 'Rodríguez', 'Affiliation': 'Biofabri, Pontevedra, Spain.'}, {'ForeName': 'Jesús', 'Initials': 'J', 'LastName': 'Gonzalo-Asensio', 'Affiliation': 'Department of Microbiology, Faculty of Medicine, University of Zaragoza, Zaragoza, Spain; CIBERES and Research Network on Respiratory Diseases, Spanish Ministry of Health and Instituto de Salud Carlos III, Madrid, Spain.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Fritzell', 'Affiliation': 'Tuberculosis Vaccine Initiative, Lelystad, Netherlands.'}, {'ForeName': 'Jelle', 'Initials': 'J', 'LastName': 'Thole', 'Affiliation': 'Tuberculosis Vaccine Initiative, Lelystad, Netherlands.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Martin', 'Affiliation': 'Department of Microbiology, Faculty of Medicine, University of Zaragoza, Zaragoza, Spain; CIBERES and Research Network on Respiratory Diseases, Spanish Ministry of Health and Instituto de Salud Carlos III, Madrid, Spain; Servicio de Microbiología, Hospital Miguel Servet, ISS Aragon, Zaragoza, Spain.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Scriba', 'Affiliation': 'South African Tuberculosis Vaccine Initiative, Institute of Infectious Disease and Molecular Medicine and Division of Immunology, Department of Pathology, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Hatherill', 'Affiliation': 'South African Tuberculosis Vaccine Initiative, Institute of Infectious Disease and Molecular Medicine and Division of Immunology, Department of Pathology, University of Cape Town, Cape Town, South Africa. Electronic address: mark.hatherill@uct.ac.za.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Respiratory medicine,['10.1016/S2213-2600(19)30251-6'] 1515,32060497,"Glycolysis/gluconeogenesis- and tricarboxylic acid cycle-related metabolites, Mediterranean diet, and type 2 diabetes.","BACKGROUND Glycolysis/gluconeogenesis and tricarboxylic acid (TCA) cycle metabolites have been associated with type 2 diabetes (T2D). However, the associations of these metabolites with T2D incidence and the potential effect of dietary interventions remain unclear. OBJECTIVES We aimed to evaluate the association of baseline and 1-y changes in glycolysis/gluconeogenesis and TCA cycle metabolites with insulin resistance and T2D incidence, and the potential modifying effect of Mediterranean diet (MedDiet) interventions. METHODS We included 251 incident T2D cases and 638 noncases in a nested case-cohort study within the PREDIMED Study during median follow-up of 3.8 y. Participants were allocated to MedDiet + extra-virgin olive oil, MedDiet + nuts, or control diet. Plasma metabolites were measured using a targeted approach by LC-tandem MS. We tested the associations of baseline and 1-y changes in glycolysis/gluconeogenesis and TCA cycle metabolites with subsequent T2D risk using weighted Cox regression models and adjusting for potential confounders. We designed a weighted score combining all these metabolites and applying the leave-one-out cross-validation approach. RESULTS Baseline circulating concentrations of hexose monophosphate, pyruvate, lactate, alanine, glycerol-3 phosphate, and isocitrate were significantly associated with higher T2D risk (17-44% higher risk for each 1-SD increment). The weighted score including all metabolites was associated with a 30% (95% CI: 1.12, 1.51) higher relative risk of T2D for each 1-SD increment. Baseline lactate and alanine were associated with baseline and 1-y changes of homeostasis model assessment of insulin resistance. One-year increases in most metabolites and in the weighted score were associated with higher relative risk of T2D after 1 y of follow-up. Lower risks were observed in the MedDiet groups than in the control group although no significant interactions were found after adjusting for multiple comparisons. CONCLUSIONS We identified a panel of glycolysis/gluconeogenesis-related metabolites that was significantly associated with T2D risk in a Mediterranean population at high cardiovascular disease risk. A MedDiet could counteract the detrimental effects of these metabolites.This trial was registered at controlled-trials.com as ISRCTN35739639.",2020,"Lower risks were observed in the MedDiet groups than in the control group although no significant interactions were found after adjusting for multiple comparisons. ","['251 incident T2D cases and 638 noncases in a nested case-cohort study within the PREDIMED Study during median follow-up of 3.8 y. Participants', 'Mediterranean population at high cardiovascular disease risk']","['MedDiet\xa0+\xa0extra-virgin olive oil, MedDiet\xa0+\xa0nuts, or control diet', 'gluconeogenesis and tricarboxylic acid ', 'Glycolysis/gluconeogenesis- and tricarboxylic acid cycle-related metabolites, Mediterranean diet', 'Mediterranean diet (MedDiet) interventions']","['Plasma metabolites', 'Lower risks', 'hexose monophosphate, pyruvate, lactate, alanine, glycerol-3 phosphate, and isocitrate', 'T2D risk', 'Baseline lactate and alanine', 'weighted score including all metabolites']","[{'cui': 'C0761050', 'cui_str': '(GVGVP)251'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]","[{'cui': 'C1138412', 'cui_str': 'Mediterranean Diet'}, {'cui': 'C0555061', 'cui_str': 'Virgin'}, {'cui': 'C0069449', 'cui_str': 'olive oil'}, {'cui': 'C0028723', 'cui_str': 'Nut'}, {'cui': 'C0743195', 'cui_str': 'Dietary control'}, {'cui': 'C0017715', 'cui_str': 'Gluconeogenesis'}, {'cui': 'C0001128', 'cui_str': 'Acid'}, {'cui': 'C0017952', 'cui_str': 'Glycolysis'}, {'cui': 'C0008858', 'cui_str': 'Krebs cycle pathway'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0019494', 'cui_str': 'Hexose'}, {'cui': 'C0034354', 'cui_str': 'Pyruvates'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0001898', 'cui_str': 'Alanine'}, {'cui': 'C0051369', 'cui_str': 'alpha-glycerophosphoric acid'}, {'cui': 'C0022160', 'cui_str': 'Isocitrates'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0332257', 'cui_str': 'Including'}]",251.0,0.0569746,"Lower risks were observed in the MedDiet groups than in the control group although no significant interactions were found after adjusting for multiple comparisons. ","[{'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Guasch-Ferré', 'Affiliation': 'Department of Nutrition, Harvard TH Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'José L', 'Initials': 'JL', 'LastName': 'Santos', 'Affiliation': 'Department of Nutrition, Diabetes and Metabolism, School of Medicine, Pontificia Universidad Católica de Chile, Santiago, Chile.'}, {'ForeName': 'Miguel A', 'Initials': 'MA', 'LastName': 'Martínez-González', 'Affiliation': 'Department of Nutrition, Harvard TH Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Clary B', 'Initials': 'CB', 'LastName': 'Clish', 'Affiliation': 'Broad Institute of MIT and Harvard University, Cambridge, MA, USA.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Razquin', 'Affiliation': 'Department of Preventive Medicine and Public Health, IdiSNA (Health Research Institute of Navarra), University of Navarra, Pamplona, Spain.'}, {'ForeName': 'Dong', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': 'Department of Nutrition, Harvard TH Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Liming', 'Initials': 'L', 'LastName': 'Liang', 'Affiliation': 'Department of Biostatistics, Harvard TH Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Nutrition, Harvard TH Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Courtney', 'Initials': 'C', 'LastName': 'Dennis', 'Affiliation': 'Broad Institute of MIT and Harvard University, Cambridge, MA, USA.'}, {'ForeName': 'Dolores', 'Initials': 'D', 'LastName': 'Corella', 'Affiliation': 'The Spanish Biomedical Research Center in Physiopathology of Obesity and Nutrition, Health Institute Carlos III, Madrid, Spain.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Muñoz-Bravo', 'Affiliation': 'Department of Public Health and Psychiatry, University of Málaga, Málaga, Spain.'}, {'ForeName': 'Dora', 'Initials': 'D', 'LastName': 'Romaguera', 'Affiliation': 'The Spanish Biomedical Research Center in Physiopathology of Obesity and Nutrition, Health Institute Carlos III, Madrid, Spain.'}, {'ForeName': 'Ramón', 'Initials': 'R', 'LastName': 'Estruch', 'Affiliation': 'The Spanish Biomedical Research Center in Physiopathology of Obesity and Nutrition, Health Institute Carlos III, Madrid, Spain.'}, {'ForeName': 'José Manuel', 'Initials': 'JM', 'LastName': 'Santos-Lozano', 'Affiliation': 'The Spanish Biomedical Research Center in Physiopathology of Obesity and Nutrition, Health Institute Carlos III, Madrid, Spain.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Castañer', 'Affiliation': 'The Spanish Biomedical Research Center in Physiopathology of Obesity and Nutrition, Health Institute Carlos III, Madrid, Spain.'}, {'ForeName': 'Angel', 'Initials': 'A', 'LastName': 'Alonso-Gómez', 'Affiliation': 'The Spanish Biomedical Research Center in Physiopathology of Obesity and Nutrition, Health Institute Carlos III, Madrid, Spain.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Serra-Majem', 'Affiliation': 'The Spanish Biomedical Research Center in Physiopathology of Obesity and Nutrition, Health Institute Carlos III, Madrid, Spain.'}, {'ForeName': 'Emilio', 'Initials': 'E', 'LastName': 'Ros', 'Affiliation': 'The Spanish Biomedical Research Center in Physiopathology of Obesity and Nutrition, Health Institute Carlos III, Madrid, Spain.'}, {'ForeName': 'Sílvia', 'Initials': 'S', 'LastName': 'Canudas', 'Affiliation': 'Human Nutrition Unit, Faculty of Medicine and Health Sciences, Pere Virgili Health Research Institute, Rovira i Virgili University, Reus, Spain.'}, {'ForeName': 'Eva M', 'Initials': 'EM', 'LastName': 'Asensio', 'Affiliation': 'Department of Preventive Medicine, University of Valencia, Valencia, Spain.'}, {'ForeName': 'Montserrat', 'Initials': 'M', 'LastName': 'Fitó', 'Affiliation': 'The Spanish Biomedical Research Center in Physiopathology of Obesity and Nutrition, Health Institute Carlos III, Madrid, Spain.'}, {'ForeName': 'Kerry', 'Initials': 'K', 'LastName': 'Pierce', 'Affiliation': 'Broad Institute of MIT and Harvard University, Cambridge, MA, USA.'}, {'ForeName': 'J Alfredo', 'Initials': 'JA', 'LastName': 'Martínez', 'Affiliation': 'The Spanish Biomedical Research Center in Physiopathology of Obesity and Nutrition, Health Institute Carlos III, Madrid, Spain.'}, {'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Salas-Salvadó', 'Affiliation': 'Human Nutrition Unit, Faculty of Medicine and Health Sciences, Pere Virgili Health Research Institute, Rovira i Virgili University, Reus, Spain.'}, {'ForeName': 'Estefanía', 'Initials': 'E', 'LastName': 'Toledo', 'Affiliation': 'Department of Preventive Medicine and Public Health, IdiSNA (Health Research Institute of Navarra), University of Navarra, Pamplona, Spain.'}, {'ForeName': 'Frank B', 'Initials': 'FB', 'LastName': 'Hu', 'Affiliation': 'Department of Nutrition, Harvard TH Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Ruiz-Canela', 'Affiliation': 'Department of Preventive Medicine and Public Health, IdiSNA (Health Research Institute of Navarra), University of Navarra, Pamplona, Spain.'}]",The American journal of clinical nutrition,['10.1093/ajcn/nqaa016'] 1516,31288906,Lung Bioposy Without Pleural Drainage.,"BACKGROUND Video-assisted thoracoscopy and atypical resection of lung parenchyma is a surgical procedure that is carried out very commonly around the world, mainly to determine the degree of malignancy of a suspect pulmonary nodule. A pleural drain is routinely inserted at the end of the procedure. The goal of our study was to evaluate the outcomes of this procedure with and without pleural drainage. METHODS From June 2015 to January 2018, 74 patients were prospectively randomized to either the chest-tube group (CT group, 37 patients) or the no-chest-tube group (NCT group, 37 patients) and were followed up until the seventh day after surgery. The postoperative duration of hospital stay was the primary endpoint; the secondary endpoints were the rates of pneumothorax and repeated chest drainage, pain intensity, and analgesic consumption. Blinding was not possible. An intention- to-treat analysis was performed. (Study registration; DRKS00008194, www.drks.de/drks.). RESULTS Hospital stays were significantly shorter in the NCT group (means and first and fourth quartiles: 1.5 [1.5; 1.5] versus 2.5 [2.5, 2.5] days, p<0.001). The two groups did not differ significantly with respect to the frequency of postoperative complications. There were two occurrences of postoperative pneumothorax in the NCT group, with one patient needing drainage via chest tube and the other needing no treatment. Pain intensity and analgesic consumption were markedly lower in the NCT group; the cumulative oral intake of metamizole and acetaminophen was also lower in the NCT group (mean ± standard deviation: 3.7 ± 2.2 g in the NCT group versus 10.0 ± 4.2 g in the CT group, p<0.001). CONCLUSION Not inserting a chest tube after video-assisted thoracoscopic lung biopsy significantly shortens the postoperative hospital stay, and the complications in the chest-tube and no-chest-tube groups are similar. Postoperative pain and analgesic consumption are markedly less when no chest tube is inserted.",2019,"Pain intensity and analgesic consumption were markedly lower in the NCT group; the cumulative oral intake of metamizole and acetaminophen was also lower in the NCT group (mean ± standard deviation: 3.7 ± 2.2 g in the NCT group versus 10.0 ± 4.2 g in the CT group, p<0.001). ","['From June 2015 to January 2018, 74 patients']","['NCT', 'chest-tube group (CT group, 37 patients) or the no-chest-tube group (NCT']","['postoperative hospital stay', 'postoperative pneumothorax', 'Pain intensity and analgesic consumption', 'Postoperative pain and analgesic consumption', 'rates of pneumothorax and repeated chest drainage, pain intensity, and analgesic consumption', 'Hospital stays', 'cumulative oral intake of metamizole and acetaminophen', 'postoperative duration of hospital stay', 'frequency of postoperative complications']","[{'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0008034', 'cui_str': 'Chest Tubes'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0032326', 'cui_str': 'Pneumothorax'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C0013103', 'cui_str': 'Drainage'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0012586', 'cui_str': 'Metamizole'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}]",74.0,0.0546485,"Pain intensity and analgesic consumption were markedly lower in the NCT group; the cumulative oral intake of metamizole and acetaminophen was also lower in the NCT group (mean ± standard deviation: 3.7 ± 2.2 g in the NCT group versus 10.0 ± 4.2 g in the CT group, p<0.001). ","[{'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Lesser', 'Affiliation': 'Department of Thoracic-and Vascular Surgery, Lung Cancer Center DKG, SRH Wald-Klinikum Gera, Germany; Department of Cardiothoracic Surgery, University Hospital Jena, Germany; Institute for Medical Statistics, Computer Science, and Data Science, University Hospital Jena, Germany.'}, {'ForeName': 'Torsten', 'Initials': 'T', 'LastName': 'Doenst', 'Affiliation': ''}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Lehmann', 'Affiliation': ''}, {'ForeName': 'Jerar', 'Initials': 'J', 'LastName': 'Mukdessi', 'Affiliation': ''}]",Deutsches Arzteblatt international,['10.3238/arztebl.2019.0329'] 1517,31483156,Heat therapy reduces sympathetic activity and improves cardiovascular risk profile in women who are obese with polycystic ovary syndrome.,"Polycystic ovary syndrome (PCOS) affects up to 15% of women and is associated with increased risk of obesity and cardiovascular disease. Repeated passive heat exposure [termed ""heat therapy"" (HT)] is a lifestyle intervention with the potential to reduce cardiovascular risk in obesity and PCOS. Women with obesity ( n = 18) with PCOS [age 27 ± 4 yr, body mass index (BMI) 41.3 ± 4.7 kg/m 2 ] were matched for age and BMI, then assigned to HT ( n = 9) or time control (CON; n = 9). HT subjects underwent 30 one-hour hot tub sessions over 8-10 wk, whereas CON subjects did not undergo HT. Muscle sympathetic nerve activity (MSNA), blood pressure, cholesterol, C-reactive protein, and markers of vascular function were assessed at the start (Pre) and end (Post) of 8-10 wk. These measures included carotid and femoral artery wall thickness and flow-mediated dilation (FMD), measured both before and after 20 min of ischemia-20 min of reperfusion (I/R) stress. HT subjects exhibited reduced MSNA burst frequency (Pre: 20 ± 8 bursts/min, Post: 13 ± 5 bursts/min, P = 0.012), systolic (Pre: 124 ± 5 mmHg, Post: 114 ± 6 mmHg; P < 0.001) and diastolic blood pressure (Pre: 77 ± 6 mmHg, Post: 68 ± 3 mmHg; P < 0.001), C-reactive protein (Pre: 19.4 ± 13.7 nmol/L, Post: 15.2 ± 12.3 nmol/L; P = 0.018), total cholesterol (Pre: 5.4 ± 1.1 mmol/L, Post: 5.0 ± 0.8 mmol/L; P = 0.028), carotid wall thickness (Pre: 0.054 ± 0.005 cm, Post: 0.044 ± 0.005 cm; P = 0.010), and femoral wall thickness (Pre: 0.056 ± 0.009 cm, Post: 0.042 ± 0.005 cm; P = 0.003). FMD significantly improved in HT subjects over time following I/R (Pre: 5.6 ± 2.5%, Post: 9.5 ± 1.7%; P < 0.001). No parameters changed over time in CON, and BMI did not change in either group. These findings indicate that HT reduces sympathetic nerve activity, provides protection from I/R stress, and substantially improves cardiovascular risk profiles in women who are obese with PCOS.",2019,"HT subjects exhibited reduced MSNA burst frequency (Pre:20±8, Post:13±5 bursts/min, p=0.012), systolic (Pre:124±5, Post:114±6 mmHg; p<0.001) and diastolic blood pressure (Pre:77±6, Post:68±3 mmHg; p<0.001), C-Reactive protein (Pre:19.4±13.7, Post:15.2±12.3 nmol/L; p=0.018), total cholesterol (Pre:5.4±1.1, Post: 5.0±0.8 mmol/L; p=0.028), carotid wall thickness (Pre:0.054±0.005 Post: 0.044±0.005 cm; p=0.010) and femoral wall thickness (Pre:0.056±0.009, Post:0.042±0.005 cm; p=0.003).","['obese women with PCOS', 'obese women with polycystic ovary syndrome', 'Eighteen obese women with PCOS (Age: 27±4y, body mass index']","[""Repeated passive heat exposure (termed 'heat therapy"", 'Heat therapy']","['sympathetic activity', 'time in CON, and BMI', 'Muscle sympathetic nerve activity (MSNA), blood pressure, cholesterol, C-reactive protein, and markers of vascular function', 'cardiovascular risk profiles', 'femoral wall thickness', 'cardiovascular risk profile', 'diastolic blood pressure', 'FMD', 'carotid and femoral artery wall thickness and flow-mediated dilation (FMD', 'risk of obesity and cardiovascular disease', 'MSNA burst frequency', 'C-Reactive protein', 'total cholesterol', 'carotid wall thickness']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0032460', 'cui_str': 'Sclerocystic Ovary Syndrome'}, {'cui': 'C3715206', 'cui_str': 'Eighteen'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C0239930', 'cui_str': 'Exposure to heat (event)'}, {'cui': 'C0150611', 'cui_str': 'Heat therapy (procedure)'}]","[{'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0459521', 'cui_str': 'Sympathetic nerve structure (body structure)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0232337', 'cui_str': 'Vascular function'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0015811', 'cui_str': 'Femur'}, {'cui': 'C0205380', 'cui_str': 'Walled (qualifier value)'}, {'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}, {'cui': 'C0015801', 'cui_str': 'Femoral Artery'}, {'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}, {'cui': 'C1322279', 'cui_str': 'Dilation'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]",18.0,0.0370644,"HT subjects exhibited reduced MSNA burst frequency (Pre:20±8, Post:13±5 bursts/min, p=0.012), systolic (Pre:124±5, Post:114±6 mmHg; p<0.001) and diastolic blood pressure (Pre:77±6, Post:68±3 mmHg; p<0.001), C-Reactive protein (Pre:19.4±13.7, Post:15.2±12.3 nmol/L; p=0.018), total cholesterol (Pre:5.4±1.1, Post: 5.0±0.8 mmol/L; p=0.028), carotid wall thickness (Pre:0.054±0.005 Post: 0.044±0.005 cm; p=0.010) and femoral wall thickness (Pre:0.056±0.009, Post:0.042±0.005 cm; p=0.003).","[{'ForeName': 'Brett R', 'Initials': 'BR', 'LastName': 'Ely', 'Affiliation': 'Department of Human Physiology, University of Oregon, Eugene, Oregon.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Francisco', 'Affiliation': 'Department of Human Physiology, University of Oregon, Eugene, Oregon.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Halliwill', 'Affiliation': 'Department of Human Physiology, University of Oregon, Eugene, Oregon.'}, {'ForeName': 'Samantha D', 'Initials': 'SD', 'LastName': 'Bryan', 'Affiliation': 'Department of Human Physiology, University of Oregon, Eugene, Oregon.'}, {'ForeName': 'Lindan N', 'Initials': 'LN', 'LastName': 'Comrada', 'Affiliation': 'Department of Human Physiology, University of Oregon, Eugene, Oregon.'}, {'ForeName': 'Emily A', 'Initials': 'EA', 'LastName': 'Larson', 'Affiliation': 'Department of Human Physiology, University of Oregon, Eugene, Oregon.'}, {'ForeName': 'Vienna E', 'Initials': 'VE', 'LastName': 'Brunt', 'Affiliation': 'Department of Human Physiology, University of Oregon, Eugene, Oregon.'}, {'ForeName': 'Christopher T', 'Initials': 'CT', 'LastName': 'Minson', 'Affiliation': 'Department of Human Physiology, University of Oregon, Eugene, Oregon.'}]","American journal of physiology. Regulatory, integrative and comparative physiology",['10.1152/ajpregu.00078.2019'] 1518,31483162,"Assessing How Gender, Relationship Status, and Item Wording Influence Cues Used by College Students to Decline Different Sexual Behaviors.","Researchers rarely examine college students' event-level refusals and how refusals may change based on sexual behavior, gender, or relationship status. As such, we assessed how sexual behavior and demographic characteristics influence cues students use to decline sexual activity. As an exploratory aim, we examined the influence of item wording (such as reading the words, not willing/non-consent vs. refusal) on how students reported declining sexual activity. A sample of 615 college students from Canada and the U.S. completed a survey; students were randomly assigned to one of two conditions that manipulated item wording (not willing/non-consent vs. refusal). Students were then prompted with four open-ended questions that asked how they refused/communicated non-consent for four sexual behaviors. An inductive coding procedure was used and five overarching themes emerged. Three themes included explicit and implicit verbal cues and two themes included explicit and implicit non-verbal cues. Wording condition (i.e., not willing/non-consent v. refusal) did not influence the types of cues reported by students. Refusal communication varied by sexual behavior and relationship status but not gender. Sexual assault prevention initiatives should include more information about the variety of refusal cues used by college students in their programming, as many of these cues are currently absent.",2020,"Sexual assault prevention initiatives should include more information about the variety of refusal cues used by college students in their programming, as many of these cues are currently absent.",['615 college students from Canada and the U.S. completed a survey; students'],['manipulated item wording (not willing/non-consent vs. refusal'],[],"[{'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}]","[{'cui': 'C0600109', 'cui_str': 'Willing (finding)'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}]",[],615.0,0.015562,"Sexual assault prevention initiatives should include more information about the variety of refusal cues used by college students in their programming, as many of these cues are currently absent.","[{'ForeName': 'Tiffany L', 'Initials': 'TL', 'LastName': 'Marcantonio', 'Affiliation': 'Department of Health, Human Performance, and Recreation, University of Arkansas.'}, {'ForeName': 'Kristen N', 'Initials': 'KN', 'LastName': 'Jozkowski', 'Affiliation': 'Department of Applied Health Science, School of Public Health-Bloomington, Indiana University.'}]",Journal of sex research,['10.1080/00224499.2019.1659218'] 1519,31343276,"Precooling, Hyperthermia, and Postexercise Cooling Rates in Humans Wearing American Football Uniforms.","CONTEXT Exertional heatstroke is one of the leading causes of death in American football players. Precooling (PC) with whole-body cold-water immersion (CWI) may prevent severe hyperthermia and, possibly, exertional heatstroke. However, it is unknown how much PC delays severe hyperthermia when participants wear American football uniforms during exercise in the heat. Does PC alter the effectiveness of CWI once participants become hyperthermic or affect perceptual variables during exercise? OBJECTIVES We asked 3 questions: (1) Does PC affect how quickly participants become hyperthermic during exercise in the heat? (2) Does PC before exercise affect rectal temperature (T rec ) cooling rates once participants become hyperthermic? (3) Does PC affect perceptual variables such as rating of perceived exertion (RPE), thermal sensation, and environmental symptoms questionnaire (ESQ) responses? DESIGN Crossover study. SETTING Laboratory. PATIENTS OR OTHER PARTICIPANTS Twelve physically active males (age = 24 ± 4 years, height = 181.8 ± 8.4 cm, mass = 79.9 ± 10.3 kg). INTERVENTION(S) On PC days, participants completed 15 minutes of CWI (9.98°C ± 0.04°C). They donned American football uniforms and exercised in the heat (temperature = 39.1°C ± 0.3°C, relative humidity = 36% ± 2%) until T rec was 39.5°C. While wearing equipment, they then underwent CWI until T rec was 38°C. Control-day procedures were the same except for the PC intervention. MAIN OUTCOME MEASURE(S) Rectal temperature, heart rate, thermal sensation, RPE, and ESQ responses were measured throughout testing. The duration of cold-water immersion was used in conjunction with T rec to calculate cooling rates. RESULTS Precooling allowed participants to exercise 17.6 ± 3.6 minutes longer before reaching 39.5°C ( t 11 = 17.0, P < .001). Precooling did not affect postexercise CWI T rec cooling rates (PC = 0.18°C/min ± 0.06°C/min, control = 0.20°C/min ± 0.09°C/min; t 11 = 0.9, P = .17); ESQ responses ( F 2,24 = 1.3, P = .3); or RPE ( F 2,22 = 2.9, P = .07). Precooling temporarily lowered thermal sensation ( F 3,26 = 21.7, P < .001) and heart rate ( F 3,29 = 21.0, P < .001) during exercise. CONCLUSIONS Because PC delayed hyperthermia without negatively affecting perceptual variables or CWI effectiveness, clinicians may consider implementing PC along with other proven strategies for preventing heat illness (eg, acclimatization).",2019,"Precooling temporarily lowered thermal sensation ( F 3,26 = 21.7, P < .001) and heart rate ( F 3,29 = 21.0, P < .001) during exercise. ","['Humans Wearing American Football Uniforms', 'Twelve physically active males (age = 24 ± 4 years, height = 181.8 ± 8.4 cm, mass ']",['Precooling (PC) with whole-body cold-water immersion (CWI'],"['Precooling, Hyperthermia, and Postexercise Cooling Rates', 'postexercise CWI T rec cooling rates', 'thermal sensation', 'Rectal temperature, heart rate, thermal sensation, RPE, and ESQ responses', 'ESQ responses', 'heart rate', 'rating of perceived exertion (RPE), thermal sensation, and environmental symptoms questionnaire (ESQ) responses', 'rectal temperature (T rec ) cooling rates']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0016517', 'cui_str': 'Football'}, {'cui': 'C4019284', 'cui_str': 'Uniforms'}, {'cui': 'C0556453', 'cui_str': 'Physically active (finding)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517876', 'cui_str': '8.4'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}]","[{'cui': 'C0444584', 'cui_str': 'Whole body (qualifier value)'}, {'cui': 'C4708833', 'cui_str': 'Cold water'}, {'cui': 'C0020940', 'cui_str': 'Immersion'}]","[{'cui': 'C0015967', 'cui_str': 'Hyperthermia'}, {'cui': 'C0036658', 'cui_str': 'Sensory Function'}, {'cui': 'C0489749', 'cui_str': 'Rectal temperature'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0445208', 'cui_str': 'RPE'}, {'cui': 'C0015264', 'cui_str': 'Exertion, function (observable entity)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",12.0,0.101959,"Precooling temporarily lowered thermal sensation ( F 3,26 = 21.7, P < .001) and heart rate ( F 3,29 = 21.0, P < .001) during exercise. ","[{'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Taylor', 'Affiliation': 'School of Rehabilitation and Medical Sciences, Central Michigan University, Mount Pleasant.'}, {'ForeName': 'Kevin C', 'Initials': 'KC', 'LastName': 'Miller', 'Affiliation': 'School of Rehabilitation and Medical Sciences, Central Michigan University, Mount Pleasant.'}]",Journal of athletic training,['10.4085/1062-6050-175-18'] 1520,32439482,Inflammatory and fibroblastic effects of azithromycin on cyclosporine-induced gingival overgrowth in renal transplanted patients with and without scaling: A randomized clinical trial.,"BACKGROUND This study aimed to evaluate the effect of azithromycin (AZM) on the inflammatory and fibroblastic part of cyclosporine A (CsA)-induced gingival overgrowth (GO) in renal transplanted patients. METHODS In this randomized clinical trial, subjects with GO receiving CsA were randomly divided into two groups: those receiving 5-day AZM only (n = 12; group 1) and those receiving scaling and prescribed AZM after 2 months (n = 12; group 2). Both groups were evaluated for several indices (gingival hyperplastic index, plaque and bleeding index, clinical crown length) at the first visit and the 4th and 8th week in group 1, and at the first visit and the 4th, 8th, 12th, and 16th week in group 2. RESULTS The sample included 24 individuals. The mean (SD) age of participants was 30.81 (11.13) and 34.80 (9.33) years in group 1 and 2, respectively. Based on ANCOVA, the changes in the hyperplastic index (GHI) and apico-coronal dimension (ACD) of it were statistically significant in professional scaling accompanied by AZM group (P = 0.012 and 0.031, respectively). However, no significant change was observed in mean indices after prescribing AZM in 5-day AZM regimen group (P = 0.664 and 0.882, respectively). According to one-way ANOVA, we found a statistically significant correlation in GHI, ACD, bleeding index (BI), and plaque index (PI) accounting for P = 0.012, 0.003, 0.002, and <0.001, respectively. CONCLUSIONS Findings suggest that AZM cannot influence the fibroblastic part of GO in presence of gum inflammation while the therapy can improve GO after resolving it with scaling.",2020,"Both groups were evaluated for several indices (gingival hyperplastic index, plaque and bleeding index, clinical crown length) at the first visit and the 4th and 8th week in group 1, and at the first visit and the 4th, 8th, 12th, and 16th week in group 2. ","['renal transplanted patients', 'The sample included 24 individuals', 'renal transplanted patients with and without scaling', 'subjects with GO receiving CsA']","['cyclosporine A (CsA)-induced gingival overgrowth (GO', 'AZM', 'receiving scaling and prescribed AZM', '5-day AZM', 'azithromycin (AZM', 'azithromycin', 'cyclosporine']","['gingival overgrowth', 'several indices (gingival hyperplastic index, plaque and bleeding index, clinical crown length', 'GHI, ACD, bleeding index (BI), and plaque index (PI', 'Inflammatory and fibroblastic effects', 'hyperplastic index (GHI) and apico-coronal dimension (ACD', 'mean indices', 'professional scaling']","[{'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0376480', 'cui_str': 'Gingival enlargement'}, {'cui': 'C0010592', 'cui_str': 'Cyclosporine'}]","[{'cui': 'C0010592', 'cui_str': 'Cyclosporine'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0376480', 'cui_str': 'Gingival enlargement'}, {'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C2239117', 'cui_str': 'Prescription of drug'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0376480', 'cui_str': 'Gingival enlargement'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0017562', 'cui_str': 'Gingival structure'}, {'cui': 'C0020507', 'cui_str': 'Hyperplasia'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0010384', 'cui_str': 'Crown'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0205123', 'cui_str': 'Coronal'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0011390', 'cui_str': 'Dental Plaque Indices'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",24.0,0.0349711,"Both groups were evaluated for several indices (gingival hyperplastic index, plaque and bleeding index, clinical crown length) at the first visit and the 4th and 8th week in group 1, and at the first visit and the 4th, 8th, 12th, and 16th week in group 2. ","[{'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Beihaghi', 'Affiliation': 'Sabzevar University of Medical Sciences, Sabzevar, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Mohammadi', 'Affiliation': 'Department of Periodontics, School of Dentistry, Kerman University of Medical Sciences, Kerman, Iran.'}, {'ForeName': 'Mohammad Reza', 'Initials': 'MR', 'LastName': 'Zarei', 'Affiliation': 'Department of Oral Medicine, School of Dentistry, Kerman University of Medical Sciences, Kerman, Iran.'}, {'ForeName': 'Jalal', 'Initials': 'J', 'LastName': 'Azmandian', 'Affiliation': 'Department of Nephrology, Shafa Hospital, Kerman University of Medical Sciences, Kerman, Iran.'}, {'ForeName': 'Hamidreza Baghani', 'Initials': 'HB', 'LastName': 'Aval', 'Affiliation': 'Department of Urology, School of Medicine, Sabzevar University of Medical Sciences, Sabzevar, Iran. Electronic address: https://mail.google.com/mail/u/0/h/sif60x9sjdad/?&cs=wh&v=b&to=hamidreza_baghani@yahoo.com.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Sahebkar', 'Affiliation': 'Department of Social Medicine, School of Medicine, Sabzevar University of Medical Sciences, Sabzevar, Iran.'}]",Journal of oral biosciences,['10.1016/j.job.2020.04.001'] 1521,32439573,"A commentary on: ""Efficacy of single layered intestinal anastomosis over double layered intestinal anastomosis - an open labelled, randomised control trial"".",,2020,,[],['single layered intestinal anastomosis'],[],[],"[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0192711', 'cui_str': 'Anastomosis of intestine'}]",[],,0.0957589,,"[{'ForeName': 'Alethea', 'Initials': 'A', 'LastName': 'Tang', 'Affiliation': 'Aneurin Bevan University Health Board, Newport, Wales, United Kingdom.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Beamish', 'Affiliation': 'Swansea University Medical School, Swansea University, Swansea, Wales, United Kingdom; Department of Surgical Research and Education, Institute of Clinical Sciences, Gothenburg University, Gothenburg, 41345, Sweden. Electronic address: beamishaj@gmail.com.'}]","International journal of surgery (London, England)",['10.1016/j.ijsu.2020.05.041'] 1522,31483146,Physical Analysis of the Breast After Direct Breastfeeding Compared with Hand or Pump Expression: A Randomized Clinical Trial.,"Background: Expressing human milk using commercially available pumps has increased. Most women use mechanical means to transfer their milk at some point during lactation. Yet, there is very little quantification of any breast tissue changes that occur when using mechanical devices to facilitate milk transfer. Objective: Women comfortable with breastfeeding were recruited to participate in a study to measure physical changes of the breast with a variety of human milk transfer modalities under close observation. Materials and Methods: Direct breastfeeding with their infant, hand expression, and mechanical milk transfer using two commonly available breast pumps were utilized over four milk transfer sessions with each participant. Each participant directly breastfed on the first milk transfer session and the remaining modalities were randomized. Measurements were taken before and after each modality using digital calipers. Participants completed a modified pain scale after each observation. Measurements taken after breastfeeding were used as the control for data interpretation for each participant. After a 20-minute rest period, breast tissue was again examined, and tissue appearance was recorded. Within-subject modality differences were calculated, and paired analysis mean difference and standard error of the mean are presented. Results: Fifty eligible women were approached with 92% participating. The ""before"" measurements were not significant for all the modalities. The ""after"" measurements were significantly different at p  < 0.003 for breast pumps but not for breastfeeding or hand expressing. Many participants indicated pain with pumping. Conclusion: Mechanical pump use correlated with significantly increased length and diameter of the nipple compared with the post-breastfeeding and hand expressing dimensions. Pump use correlated with significant pain scores and resulted in localized inflammatory changes. Understanding how pumps affect breast tissue is helpful in improving experiences with breast pumps and may improve breastfeeding outcomes. Additional research is needed to better understand ramifications of long-term use of breast pumps.",2019,Mechanical pump use correlated with significantly increased length and diameter of the nipple compared with the post-breastfeeding and hand expressing dimensions.,"['Results: Fifty eligible women were approached with 92% participating', 'Women comfortable with breastfeeding were recruited to participate in a study to measure physical changes of the breast with a variety of human milk transfer modalities under close observation']",['Direct Breastfeeding Compared with Hand or Pump Expression'],"['modified pain scale', 'pain with pumping', 'length and diameter of the nipple', 'pain scores']","[{'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0006141', 'cui_str': 'Breast'}, {'cui': 'C0026140', 'cui_str': 'Breast Milk'}, {'cui': 'C0040671', 'cui_str': 'Transfer'}, {'cui': 'C0581528', 'cui_str': 'Close observation (regime/therapy)'}]","[{'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C3854321', 'cui_str': 'Expression'}]","[{'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C1504479', 'cui_str': 'Pain scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C1301886', 'cui_str': 'Diameter (qualifier value)'}, {'cui': 'C0457424', 'cui_str': 'Nippled (qualifier value)'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}]",50.0,0.0346581,Mechanical pump use correlated with significantly increased length and diameter of the nipple compared with the post-breastfeeding and hand expressing dimensions.,"[{'ForeName': 'Jimi', 'Initials': 'J', 'LastName': 'Francis', 'Affiliation': 'Department of Health & Kinesiology, University of Texas at Tyler, Tyler, Texas.'}, {'ForeName': 'Darby', 'Initials': 'D', 'LastName': 'Dickton', 'Affiliation': 'CAPT, USAF 60 AMC SGCS, University of California, Davis - Health System, Sacramento, California.'}]",Breastfeeding medicine : the official journal of the Academy of Breastfeeding Medicine,['10.1089/bfm.2019.0008'] 1523,31495952,"Safety and Efficacy of Teduglutide in Pediatric Patients With Intestinal Failure due to Short Bowel Syndrome: A 24-Week, Phase III Study.","BACKGROUND This study evaluated the safety and efficacy of teduglutide in pediatric patients with short bowel syndrome-associated intestinal failure (SBS-IF). METHODS A 24-week, phase III trial with 2 randomized, double-blind teduglutide dose groups and a nonblinded standard of care (SOC) arm was used; patients received 0.025 mg/kg or 0.05 mg/kg teduglutide once daily. Safety end points included treatment-emergent adverse events (TEAEs) and growth parameters. The primary efficacy/pharmacodynamic end point was the number of patients who achieved a ≥20% reduction in parenteral support (PS) from baseline at week 24. RESULTS All 59 enrolled patients completed the study (0.025 mg/kg, n = 24; 0.05 mg/kg, n = 26; SOC, n = 9). Baseline demographics and disease characteristics were comparable among groups. TEAEs were reported by 98% and 100% of patients in the teduglutide and SOC groups, respectively. The most common TEAEs in the teduglutide-treated groups were pyrexia and vomiting. The primary end point was achieved by 13 (54.2%), 18 (69.2%), and 1 (11.1%) patients who received 0.025 mg/kg teduglutide, 0.05 mg/kg teduglutide, and SOC, respectively (P < 0.05 vs SOC). Both 0.025-mg/kg and 0.05-mg/kg teduglutide groups showed clinically significant reductions in PS volume (P < 0.05 vs SOC), PS calories, days per week and hours per day of PS infusions, and increases in enteral nutrition and plasma citrulline at week 24 compared with baseline. Two (8.3%, 0.025 mg/kg teduglutide) and 3 patients (11.5%, 0.05 mg/kg teduglutide) achieved enteral autonomy. CONCLUSION The safety profile of teduglutide was similar to that reported previously in children and adults. Treatment with teduglutide was associated with significant reductions in PS for pediatric patients with SBS-IF over 24 weeks.",2020,Treatment with teduglutide was associated with significant reductions in PS for pediatric patients with SBS-IF over 24 weeks.,"['pediatric patients with short bowel syndrome-associated intestinal failure (SBS-IF', 'Pediatric Patients With Intestinal Failure due to Short Bowel Syndrome', 'children and adults']","['teduglutide', 'Teduglutide']","['Baseline demographics and disease characteristics', 'enteral autonomy', 'safety profile of teduglutide', 'PS', 'enteral nutrition and plasma citrulline', 'Safety and Efficacy', 'PS volume', 'treatment-emergent adverse events (TEAEs) and growth parameters', 'pyrexia and vomiting', 'parenteral support (PS']","[{'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0036992', 'cui_str': 'Short Bowel Syndrome'}, {'cui': 'C0021853', 'cui_str': 'Intestines'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C1530889', 'cui_str': 'teduglutide'}]","[{'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1304890', 'cui_str': 'Enteral (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1530889', 'cui_str': 'teduglutide'}, {'cui': 'C0086225', 'cui_str': 'Enteral Feeding'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0008864', 'cui_str': 'Citrulline'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0015967', 'cui_str': 'Hyperthermia'}, {'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C4522267', 'cui_str': 'Parenteral (intended site)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}]",59.0,0.196483,Treatment with teduglutide was associated with significant reductions in PS for pediatric patients with SBS-IF over 24 weeks.,"[{'ForeName': 'Samuel A', 'Initials': 'SA', 'LastName': 'Kocoshis', 'Affiliation': ""Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, USA.""}, {'ForeName': 'Russell J', 'Initials': 'RJ', 'LastName': 'Merritt', 'Affiliation': ""Children's Hospital Los Angeles and Keck School of Medicine, University of Southern California, Los Angeles, California, USA.""}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Hill', 'Affiliation': 'Great Ormond Street Hospital for Children NHS Foundation Trust, London, UK.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Protheroe', 'Affiliation': ""Birmingham Children's Hospital NHS Foundation Trust, Birmingham, UK.""}, {'ForeName': 'Beth A', 'Initials': 'BA', 'LastName': 'Carter', 'Affiliation': ""Texas Children's Hospital, Baylor College of Medicine, Houston, Texas, USA.""}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Horslen', 'Affiliation': ""Seattle Children's Hospital and University of Washington School of Medicine, Seattle, Washington, USA.""}, {'ForeName': 'Simin', 'Initials': 'S', 'LastName': 'Hu', 'Affiliation': 'Shire Human Genetic Therapies, Inc, Lexington, Massachusetts, USA.'}, {'ForeName': 'Stuart S', 'Initials': 'SS', 'LastName': 'Kaufman', 'Affiliation': 'MedStar Georgetown University Hospital, Washington, District of Columbia, USA.'}, {'ForeName': 'David F', 'Initials': 'DF', 'LastName': 'Mercer', 'Affiliation': 'University of Nebraska Medical Center, Omaha, Nebraska, USA.'}, {'ForeName': 'Mikko P', 'Initials': 'MP', 'LastName': 'Pakarinen', 'Affiliation': ""Children's Hospital, Pediatric Research Center, University of Helsinki, Helsinki University Hospital, Helsinki, Finland.""}, {'ForeName': 'Robert S', 'Initials': 'RS', 'LastName': 'Venick', 'Affiliation': ""Mattel Children's Hospital UCLA, Department of Pediatrics, Los Angeles, California, USA.""}, {'ForeName': 'Paul W', 'Initials': 'PW', 'LastName': 'Wales', 'Affiliation': 'The Hospital for Sick Children, Toronto, Ontario, Canada.'}, {'ForeName': 'Andrew A', 'Initials': 'AA', 'LastName': 'Grimm', 'Affiliation': 'Shire Human Genetic Therapies, Inc, Cambridge, Massachusetts, USA.'}]",JPEN. Journal of parenteral and enteral nutrition,['10.1002/jpen.1690'] 1524,31591263,Absolute Quantification of Apolipoproteins Following Treatment with Omega-3 Carboxylic Acids and Fenofibrate Using a High Precision Stable Isotope-labeled Recombinant Protein Fragments Based SRM Assay.,"Stable isotope-labeled standard (SIS) peptides are used as internal standards in targeted proteomics to provide robust protein quantification, which is required in clinical settings. However, SIS peptides are typically added post trypsin digestion and, as the digestion efficiency can vary significantly between peptides within a protein, the accuracy and precision of the assay may be compromised. These drawbacks can be remedied by a new class of internal standards introduced by the Human Protein Atlas project, which are based on SIS recombinant protein fragments called SIS PrESTs. SIS PrESTs are added initially to the sample and SIS peptides are released on trypsin digestion. The SIS PrEST technology is promising for absolute quantification of protein biomarkers but has not previously been evaluated in a clinical setting. An automated and scalable solid phase extraction workflow for desalting and enrichment of plasma digests was established enabling simultaneous preparation of up to 96 samples. Robust high-precision quantification of 13 apolipoproteins was achieved using a novel multiplex SIS PrEST-based LC-SRM/MS Tier 2 assay in non-depleted human plasma. The assay exhibited inter-day coefficients of variation between 1.5% and 14.5% (median = 3.5%) and was subsequently used to investigate the effects of omega-3 carboxylic acids (OM3-CA) and fenofibrate on these 13 apolipoproteins in human plasma samples from a randomized placebo-controlled trial, EFFECT I (NCT02354976). No significant changes were observed in the OM3-CA arm, whereas treatment with fenofibrate significantly increased apoAII and reduced apoB, apoCI, apoE and apoCIV levels. The reduction in apoCIV following fenofibrate treatment is a novel finding. The study demonstrates that SIS PrESTs can facilitate the generation of robust multiplexed biomarker Tier 2 assays for absolute quantification of proteins in clinical studies.",2019,"No significant changes were observed in the OM3-CA arm, while treatment with fenofibrate significantly increased apoAII and reduced apoB, apoCI, apoE and apoCIV levels.",[],"['OM3-CA', 'Omega-3 Carboxylic Acids and Fenofibrate', 'Stable isotope-labeled standard (SIS) peptides', 'fenofibrate', 'omega-3 carboxylic acids (OM3-CA) and fenofibrate']","['apoAII and reduced apoB, apoCI, apoE and apoCIV levels']",[],"[{'cui': 'C3832882', 'cui_str': 'Omega-3 carboxylic acids'}, {'cui': 'C0033228', 'cui_str': 'Fenofibrate'}, {'cui': 'C0302918', 'cui_str': 'Stable isotope (substance)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0030956', 'cui_str': 'Peptides'}]","[{'cui': 'C0003593', 'cui_str': 'ApoB'}, {'cui': 'C0003595', 'cui_str': 'Apo-E'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",,0.013594,"No significant changes were observed in the OM3-CA arm, while treatment with fenofibrate significantly increased apoAII and reduced apoB, apoCI, apoE and apoCIV levels.","[{'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Hober', 'Affiliation': 'Science for Life Laboratory, KTH - Royal Institute of Technology, Stockholm, Sweden.'}, {'ForeName': 'Fredrik', 'Initials': 'F', 'LastName': 'Edfors', 'Affiliation': 'Science for Life Laboratory, KTH - Royal Institute of Technology, Stockholm, Sweden.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Ryaboshapkina', 'Affiliation': 'Translational Science, Cardiovascular, Renal and Metabolism, IMED Biotech Unit, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'Malmqvist', 'Affiliation': 'Translational Science, Cardiovascular, Renal and Metabolism, IMED Biotech Unit, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Rosengren', 'Affiliation': 'Translational Science, Cardiovascular, Renal and Metabolism, IMED Biotech Unit, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Percy', 'Affiliation': 'Department of Applications Development, Cambridge Isotope Laboratories, Inc., Tewksbury, MA 01876.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Lind', 'Affiliation': 'Department of Medical Sciences, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Björn', 'Initials': 'B', 'LastName': 'Forsström', 'Affiliation': 'Science for Life Laboratory, KTH - Royal Institute of Technology, Stockholm, Sweden.'}, {'ForeName': 'Mathias', 'Initials': 'M', 'LastName': 'Uhlén', 'Affiliation': 'Science for Life Laboratory, KTH - Royal Institute of Technology, Stockholm, Sweden.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Oscarsson', 'Affiliation': 'Global Medicines Development, Cardiovascular, Renal and Metabolism, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Tasso', 'Initials': 'T', 'LastName': 'Miliotis', 'Affiliation': 'Translational Science, Cardiovascular, Renal and Metabolism, IMED Biotech Unit, AstraZeneca, Gothenburg, Sweden Tasso.Miliotis@astrazeneca.com.'}]",Molecular & cellular proteomics : MCP,['10.1074/mcp.RA119.001765'] 1525,31077582,"The Safety, Tolerability, and Pharmacokinetics Profile of BT-11, an Oral, Gut-Restricted Lanthionine Synthetase C-Like 2 Agonist Investigational New Drug for Inflammatory Bowel Disease: A Randomized, Double-Blind, Placebo-Controlled Phase I Clinical Trial.","BT-11 is a new oral, gut-restricted, first-in-class investigational drug for Crohn disease (CD) and ulcerative colitis (UC) that targets the lanthionine synthetase C-like 2 (LANCL2) pathway and immunometabolic mechanisms. Oral BT-11 was assessed for safety, tolerability, and pharmacokinetics (PK) in normal healthy volunteers (n = 70) in a randomized, double-blind, placebo-controlled trial. Subjects (n = 70) were randomly assigned to one of five single ascending dose cohorts (up to 100 mg/kg, p.o.) and three multiple ascending dose cohorts [up to 100 mg/kg daily (QD) for seven days, orally]. Safety and tolerability were assessed by adverse event (AE) reporting, vital signs, electrocardiogram, hematology, and clinical chemistry. BT-11 did not increase total or gastrointestinal AE rates, as compared with placebo, and no serious adverse events were observed. Oral BT-11 dosing does not result in any clinically significant findings by biochemistry, coagulation, electrocardiogram, hematology, or urinalysis as compared with placebo. Mean fecal concentrations of BT-11 increased linearly with increasing oral doses, with 2.39 mg/g at 7.7 mg/kg on day 7 of the multiple ascending dose (MAD). Analysis of plasma pharmacokinetics indicates that maximum systemic concentrations are approximately 1/6000th of observed concentrations in feces and the distal gastrointestinal tract. Fecal calprotectin levels were lower in BT-11 treated groups as compared to placebo. BT-11 significantly decreases interferon gamma positive (IFNγ+) and tumor necrosis factor alpha positive (TNFα+) cluster of differentiation 4 positive (CD4+) T cells and increases forkhead box P3 positive (FOXP3+) CD4+ T cells in colonic lamina propria mononuclear cells from patients with CD and patients with UC at concentrations of 0.01 µM when treated ex vivo. BT-11 treatment is well-tolerated with no dose-limiting toxicities up to daily oral doses of 100 mg/kg (16 tablets); whereas the efficacious dose is a single tablet (8 mg/kg). Phase II studies in CD and UC patients are ongoing.",2020,"BT-11 did not increase total or gastrointestinal AE rates, as compared with placebo, and no serious adverse events were observed.","['Inflammatory Bowel Disease', 'Subjects (n = 70', 'normal healthy volunteers (n = 70']","['Placebo', 'placebo']","['safety, tolerability, and pharmacokinetics (PK', 'total or gastrointestinal AE rates', 'biochemistry, coagulation, electrocardiogram, hematology, or urinalysis', 'interferon gamma positive (IFNγ+) and tumor necrosis factor alpha positive (TNFα+) cluster of differentiation', 'Safety, Tolerability, and Pharmacokinetics Profile of BT-11', 'Fecal calprotectin levels', 'adverse event (AE) reporting, vital signs, electrocardiogram, hematology, and clinical chemistry', '4 positive (CD4+) T cells and increases forkhead box P3 positive (FOXP3+) CD4+ T cells in colonic lamina propria mononuclear cells', 'serious adverse events', 'Mean fecal concentrations of BT-11', 'Safety and tolerability']","[{'cui': 'C0021390', 'cui_str': 'Inflammatory Bowel Diseases'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0005477', 'cui_str': 'Biochemistry'}, {'cui': 'C0441509', 'cui_str': 'Coagulation - action (qualifier value)'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0018943', 'cui_str': 'Hematology'}, {'cui': 'C0042014', 'cui_str': 'Urinalysis'}, {'cui': 'C0021745', 'cui_str': 'interferon gamma'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C1964053', 'cui_str': 'Faecal calprotectin'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0518766'}, {'cui': 'C0008000', 'cui_str': 'Chemistry, Clinical'}, {'cui': 'C0039194', 'cui_str': 'Thymus-Dependent Lymphocytes'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C1638312', 'cui_str': 'Boxes'}, {'cui': 'C0227354', 'cui_str': 'Colonic lamina propria (body structure)'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",70.0,0.509886,"BT-11 did not increase total or gastrointestinal AE rates, as compared with placebo, and no serious adverse events were observed.","[{'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Leber', 'Affiliation': 'Landos Biopharma Inc., Blacksburg, Virginia, USA.'}, {'ForeName': 'Raquel', 'Initials': 'R', 'LastName': 'Hontecillas', 'Affiliation': 'Landos Biopharma Inc., Blacksburg, Virginia, USA.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Zoccoli-Rodriguez', 'Affiliation': 'Landos Biopharma Inc., Blacksburg, Virginia, USA.'}, {'ForeName': 'Jean-Frederic', 'Initials': 'JF', 'LastName': 'Colombel', 'Affiliation': 'Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York, New York, USA.'}, {'ForeName': 'Jyoti', 'Initials': 'J', 'LastName': 'Chauhan', 'Affiliation': 'Landos Biopharma Inc., Blacksburg, Virginia, USA.'}, {'ForeName': 'Marion', 'Initials': 'M', 'LastName': 'Ehrich', 'Affiliation': 'Department of Biomedical Sciences & Pathobiology, Virginia Tech, Blacksburg, Virginia, USA.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Farinola', 'Affiliation': 'Royal Adelaide Hospital, North Terrace, Adelaide, South Australia, Australia.'}, {'ForeName': 'Josep', 'Initials': 'J', 'LastName': 'Bassaganya-Riera', 'Affiliation': 'Landos Biopharma Inc., Blacksburg, Virginia, USA.'}]",Inflammatory bowel diseases,['10.1093/ibd/izz094'] 1526,30868641,Problem-solving therapy reduces subjective burden levels in caregivers of family members with mild cognitive impairment or early-stage dementia: Secondary analysis of a randomized clinical trial.,"OBJECTIVES Interventions addressing burden have limited impact among long-term family caregivers. We examined whether problem-solving therapy (PST) would reduce burden levels of caregivers of individuals diagnosed with mild cognitive impairment (MCI) or early-stage dementia (AD). METHODS Caregivers (N = 73) randomly received PST or nutritional training (NT). Burden measures were assessed over 1-year post-intervention. RESULTS Relative to NT, caregivers receiving PST endorsed improved perceived burden levels over time, regardless of the type of caregiver. Distress over the care recipient's dementia-related behaviors remained low over time among MCI caregivers receiving PST, while these burden levels among MCI caregivers receiving NT rose over time. AD caregivers receiving PST endorsed reductions in these burden levels over time, while AD caregivers in the NT group endorsed higher burden levels over time. CONCLUSION PST, taught early in the caregiving trajectory, improves subjective burden levels among caregivers of family members with relatively mild cognitive deficits.",2019,"AD caregivers receiving PST endorsed reductions in these burden levels over time, while AD caregivers in the NT group endorsed higher burden levels over time. ","['caregivers of individuals diagnosed with mild cognitive impairment (MCI) or early-stage dementia (AD', 'caregivers of family members with mild cognitive impairment or early-stage dementia', 'caregivers of family members with relatively mild cognitive deficits', 'Caregivers (N\xa0=\xa073) randomly received']","['problem-solving therapy (PST', 'Problem-solving therapy', 'PST or nutritional training (NT']","['subjective burden levels', 'Distress']","[{'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C1270972', 'cui_str': 'Mild Neurocognitive Disorder'}, {'cui': 'C2363430', 'cui_str': 'Early stage (qualifier value)'}, {'cui': 'C0497327', 'cui_str': 'Amentia'}, {'cui': 'C0086282', 'cui_str': 'Person in the family'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0338656', 'cui_str': 'Cognitive Dysfunction'}]","[{'cui': 'C1303140', 'cui_str': 'Problem solving therapy'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}]",73.0,0.30614,"AD caregivers receiving PST endorsed reductions in these burden levels over time, while AD caregivers in the NT group endorsed higher burden levels over time. ","[{'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Garand', 'Affiliation': 'Duquesne University School of Nursing, Pittsburgh, Pennsylvania, United States.'}, {'ForeName': 'Jennifer Q', 'Initials': 'JQ', 'LastName': 'Morse', 'Affiliation': 'Chatham University, Pittsburgh, Pennsylvania, United States.'}, {'ForeName': 'Lichun', 'Initials': 'L', 'LastName': 'ChiaRebecca', 'Affiliation': 'Duquesne University School of Nursing, Pittsburgh, Pennsylvania, United States.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Barnes', 'Affiliation': 'Duquesne University School of Nursing, Pittsburgh, Pennsylvania, United States.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Dadebo', 'Affiliation': 'Duquesne University School of Pharmacy, Pittsburgh, Pennsylvania, United States.'}, {'ForeName': 'Oscar L', 'Initials': 'OL', 'LastName': 'Lopez', 'Affiliation': 'Departments of Neurology and Psychiatry. Director, Alzheimer Disease Research Center, University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, United States.'}, {'ForeName': 'Mary Amanda', 'Initials': 'MA', 'LastName': 'Dew', 'Affiliation': 'Departments of Psychiatry, Biostatistics, Epidemiology, Psychology and Clinical and Translational Science, University of Pittsburgh Schools of Medicine and Public Health, Pittsburgh, Pennsylvania, United States.'}]",International journal of geriatric psychiatry,['10.1002/gps.5095'] 1527,31331699,"Pazopanib or methotrexate-vinblastine combination chemotherapy in adult patients with progressive desmoid tumours (DESMOPAZ): a non-comparative, randomised, open-label, multicentre, phase 2 study.","BACKGROUND Desmoid tumours are locally aggressive tumours associated with substantial morbidity. No systemic treatments are approved for this disease, with methotrexate-vinblastine the only chemotherapy regimen assessed in a clinical trial setting to date. VEGF overexpression is a common feature in aggressive desmoid tumours. Pazopanib is an oral antiangiogenic agent targeting VEGF receptors 1, 2, and 3, platelet-derived growth factor receptor-like protein (PDGFR) α and β, and c-KIT tyrosine kinases. We aimed to assess antitumour activity and safety of targeted therapy or combination chemotherapy in progressive desmoid tumours. METHODS DESMOPAZ was a non-comparative, randomised, open-label, phase 2 trial conducted at 12 centres from the French Sarcoma Group. We enrolled adults (≥18 years) with progressive desmoid tumours, normal organ function and centrally documented progressive disease according to Response Evaluation Criteria in Solid Tumors version 1.1 based on two imaging assessments obtained within less than a 6-month interval. Participants were randomly assigned (2:1) to oral pazopanib 800 mg per day for up to 1 year or to an intravenous regimen combining vinblastine (5 mg/m 2 per dose) and methotrexate (30 mg/m 2 per dose), administered weekly for 6 months and then every other week for 6 months. Randomisation was stratified according to inclusion centre and tumour location. The primary endpoint was the proportion of patients who had not progressed at 6 months in the first 43 patients who had received one complete or two incomplete cycles of pazopanib. This endpoint was also assessed as a prespecified exploratory endpoint in all patients who had received one complete or two incomplete cycles of methotrexate-vinblastane. Safety analyses were done for all patients who received at least one dose of allocated treatment. This trial was registered with ClinicalTrials.gov, number NCT01876082. FINDINGS From Dec 4, 2012, to Aug 18, 2017, 72 patients were enrolled and randomly assigned (n=48 in the pazopanib group; n=24 in the methotrexate-vinblastine group). Median follow-up was 23·4 months (IQR 17·1-25·5). 46 patients in the pazopanib group and 20 patients in the methotrexate-vinblastine group were assessable for activity. In the first 43 patients assessable for the primary endpoint in the pazopanib group, the proportion of patients who had not progressed at 6 months was 83·7% (95% CI 69·3-93·2). The proportion of patients treated with methotrexate-vinblastine who had not progressed at 6 months was 45·0% (95% CI 23·1-68·5). The most common grade 3 or 4 adverse events in the pazopanib group were hypertension (n=10, 21%) and diarrhoea (n=7, 15%) and in the methotrexate-vinblastine group were neutropenia (n=10, 45%) and liver transaminitis (n=4, 18%). 11 patients (23%) had at least one serious adverse event related to study treatment in the pazopanib group, as did and six patients (27%) in the methotrexate-vinblastine group. INTERPRETATION Pazopanib has clinical activity in patients with progressive desmoid tumours and could be a valid treatment option in this rare and disabling disease. FUNDING GlaxoSmithKline and Novartis.",2019,"Pazopanib is an oral antiangiogenic agent targeting VEGF receptors 1, 2, and 3, platelet-derived growth factor receptor-like protein (PDGFR) α and β, and c-KIT tyrosine kinases.","['From Dec 4, 2012, to Aug 18, 2017, 72 patients were enrolled and randomly assigned (n=48 in the pazopanib group; n=24 in the', 'patients with progressive desmoid tumours', 'adult patients with progressive desmoid tumours (DESMOPAZ', 'enrolled adults (≥18 years) with progressive desmoid tumours, normal organ function and centrally documented progressive disease according to Response Evaluation Criteria in Solid Tumors version 1.1 based on two imaging assessments obtained within less than a 6-month interval', '12 centres from the French Sarcoma Group', 'progressive desmoid tumours', '46 patients in the pazopanib group and 20 patients in the']","['combination chemotherapy', 'pazopanib', 'vinblastine', 'methotrexate', 'Pazopanib or methotrexate-vinblastine combination chemotherapy', 'oral pazopanib', 'methotrexate-vinblastane', 'methotrexate-vinblastine', 'Pazopanib']","['activity', 'diarrhoea', 'serious adverse event', 'neutropenia', 'antitumour activity and safety', 'hypertension', 'proportion of patients who had not progressed', 'liver transaminitis']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C1831796', 'cui_str': 'pazopanib'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205329', 'cui_str': 'Progressive (qualifier value)'}, {'cui': 'C0079218', 'cui_str': 'Desmoid'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1709926', 'cui_str': 'RECIST'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C4517491', 'cui_str': 'One point one'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C1301820', 'cui_str': 'Obtained (attribute)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C1556084', 'cui_str': 'French (ethnic group)'}, {'cui': 'C1261473', 'cui_str': 'Sarcoma, Soft Tissue'}]","[{'cui': 'C0013218', 'cui_str': 'Combination Drug Therapy'}, {'cui': 'C1831796', 'cui_str': 'pazopanib'}, {'cui': 'C0042670', 'cui_str': 'Vinblastine'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}]","[{'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C2242708', 'cui_str': 'Transaminitis'}]",72.0,0.205538,"Pazopanib is an oral antiangiogenic agent targeting VEGF receptors 1, 2, and 3, platelet-derived growth factor receptor-like protein (PDGFR) α and β, and c-KIT tyrosine kinases.","[{'ForeName': 'Maud', 'Initials': 'M', 'LastName': 'Toulmonde', 'Affiliation': 'Department of Medicine, Institut Bergonié, Bordeaux, France.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Pulido', 'Affiliation': 'Clinical and Epidemiology Department and Clinical Investigation Centre, INSERM, Institut Bergonié, Bordeaux, France.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Ray-Coquard', 'Affiliation': 'Department of Medicine, Centre Léon Bérard, Lyon, France.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Andre', 'Affiliation': 'Department of Medical Oncology, Hôpital Saint-Antoine, Paris, France.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Isambert', 'Affiliation': 'Department of Medicine, Centre George-Francois Leclerc, Dijon, France.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Chevreau', 'Affiliation': 'Department of Medicine, Oncopole, Toulouse, France.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Penel', 'Affiliation': 'Department of Medicine, Centre Oscar Lambret, Lille, France.'}, {'ForeName': 'Emmanuelle', 'Initials': 'E', 'LastName': 'Bompas', 'Affiliation': ""Department of Medicine, Institut de Cancérologie de l'Ouest, Nantes, France.""}, {'ForeName': 'Esma', 'Initials': 'E', 'LastName': 'Saada', 'Affiliation': 'Department of Medicine, Centre Antoine Lacassagne, Nice, France.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Bertucci', 'Affiliation': 'Department of Medicine, Institut Paoli Calmettes, Marseille, France.'}, {'ForeName': 'Celeste', 'Initials': 'C', 'LastName': 'Lebbe', 'Affiliation': 'Department of Dermatology, Hôpital Saint-Louis, France.'}, {'ForeName': 'Axel', 'Initials': 'A', 'LastName': 'Le Cesne', 'Affiliation': 'Department of Medicine, Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Soulie', 'Affiliation': ""Department of Medicine, Institut de Cancérologie de l'Ouest, Angers, France.""}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Piperno-Neumann', 'Affiliation': 'Department of Medicine, Institut Curie, Paris, France.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Sweet', 'Affiliation': 'NantOmics, Rockville, MD, USA.'}, {'ForeName': 'Fabiola', 'Initials': 'F', 'LastName': 'Cecchi', 'Affiliation': 'NantOmics, Rockville, MD, USA.'}, {'ForeName': 'Todd', 'Initials': 'T', 'LastName': 'Hembrough', 'Affiliation': 'NantOmics, Rockville, MD, USA.'}, {'ForeName': 'Carine', 'Initials': 'C', 'LastName': 'Bellera', 'Affiliation': 'Clinical and Epidemiology Department and Clinical Investigation Centre, INSERM, Institut Bergonié, Bordeaux, France.'}, {'ForeName': 'Michèle', 'Initials': 'M', 'LastName': 'Kind', 'Affiliation': 'Department of Radiology, Institut Bergonié, Bordeaux, France.'}, {'ForeName': 'Amandine', 'Initials': 'A', 'LastName': 'Crombe', 'Affiliation': 'Department of Radiology, Institut Bergonié, Bordeaux, France.'}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Lucchesi', 'Affiliation': 'Bioinformatics Unit, Institut Bergonié, Bordeaux, France.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Le Loarer', 'Affiliation': 'Department of Pathology, Institut Bergonié, Bordeaux, France.'}, {'ForeName': 'Jean-Yves', 'Initials': 'JY', 'LastName': 'Blay', 'Affiliation': 'Department of Medicine, Centre Léon Bérard, Lyon, France.'}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Italiano', 'Affiliation': 'Department of Medicine, Institut Bergonié, Bordeaux, France; University of Bordeaux, Bordeaux, France. Electronic address: a.italiano@bordeaux.unicancer.fr.'}]",The Lancet. Oncology,['10.1016/S1470-2045(19)30276-1'] 1528,31307883,"Intermittent preventive treatment with dihydroartemisinin-piperaquine and risk of malaria following cessation in young Ugandan children: a double-blind, randomised, controlled trial.","BACKGROUND Intermittent preventive treatment (IPT) of malaria with dihydroartemisinin-piperaquine is a promising strategy for malaria prevention in young African children. However, the optimal dosing strategy is unclear and conflicting evidence exists regarding the risk of malaria after cessation of chemoprevention. We aimed to compare two dosing strategies of IPT with dihydroartemisinin-piperaquine in young Ugandan children, and to evaluate the risk of malaria after cessation of IPT. METHODS In this double-blind, randomised controlled phase 2 trial, women and their unborn children were recruited at Tororo District Hospital (Tororo, Uganda). Eligible participants were HIV-negative women aged 16 years or older with a viable pregnancy (gestational age 12-20 weeks). Women and their unborn children were randomly assigned (1:1:1:1) to one of four treatment groups, all receiving dihydroartemisinin-piperaquine, on the basis of the IPT intervention received by the woman during pregnancy: women every 8 weeks, children every 4 weeks; women every 4 weeks, children every 4 weeks; women every 8 weeks, children every 12 weeks; and women every 4 weeks, children every 12 weeks. Block randomisation was done by an independent investigator using a computer-generated randomisation list (permuted block sizes of six and 12). We analysed children on the basis of their random assignment to receive dihydroartemisinin-piperaquine (20 mg/160 mg tablets) once daily for 3 consecutive days every 4 weeks or 12 weeks. Children received study drugs from age 8 weeks to 24 months and were followed-up to age 36 months. Participants and investigators were masked to treatment allocation. The primary outcome was the incidence of symptomatic malaria during the intervention and following cessation of the intervention, adjusted for potential confounders. The primary outcome and safety were assessed in the modified intention-to-treat population, which included all children who reached 8 weeks of age and received at least one dose of study drug. This trial is registered with ClinicalTrials.gov, number NCT02163447. FINDINGS Between Oct 21, 2014, and May 18, 2015, 191 children were born, of whom 183 reached 8 weeks of age and received at least one dose of study drug and thus were included in the primary analysis (96 children in the 4-week group and 87 in the 12-week group). During the intervention, the incidence of symptomatic malaria was significantly lower among children treated every 4 weeks than children treated every 12 weeks; three episodes occurred among children treated every 4 weeks (incidence 0·018 episodes per person-year) compared with 61 episodes among children treated every 12 weeks (incidence 0·39 episodes per person-year; adjusted incidence rate ratio [aIRR] 0·041, 95% CI 0·012-0·150, p<0·0001). After cessation of IPT, children who had previously received dihydroartemisinin-piperaquine every 4 weeks had a lower incidence of symptomatic malaria than children who were treated every 12 weeks; 62 episodes occurred among children previously treated every 4 weeks (incidence 0·73 episodes per person-year) compared with 83 episodes among children treated every 12 weeks (incidence 1·1 episodes per person-year; aIRR 0·62, 0·40-0·95, p=0·028). In the 4-week group, 94 (98%) of 96 children had adverse events versus 87 (100%) of 87 children in the 12-week group. The most commonly reported adverse event was cough in both treatment groups (94 [98%] in the 4-week group vs 87 [100%] in the 12-week group). 16 children had severe adverse events (seven [7%] children in the 4-week group vs nine [10%] children in the 12-week group). No severe adverse events were thought to be related to study drug administration. One death occurred during the intervention (age 8 weeks to 24 months), which was due to respiratory failure unrelated to malaria. INTERPRETATION IPT with dihydroartemisinin-piperaquine given every 4 weeks was superior to treatment every 12 weeks for the prevention of malaria during childhood, and this protection was extended for up to 1 year after cessation of IPT. FUNDING Eunice Kennedy Shriver National Institute of Child Health and Human Development.",2019,"incidence 1·1 episodes per person-year; aIRR 0·62, 0·40-0·95, p=0·028).","['young African children', 'young Ugandan children', 'Eligible participants were HIV-negative women aged 16 years or older with a viable pregnancy (gestational age 12-20 weeks', 'Between Oct 21, 2014, and May 18, 2015, 191 children were born, of whom 183 reached 8 weeks of age and received at least one dose of study drug and thus were included in the primary analysis (96 children in the 4-week group and 87 in the 12-week group', 'women and their unborn children were recruited at Tororo District Hospital (Tororo, Uganda', 'Women and their unborn children']","['IPT intervention', 'dihydroartemisinin-piperaquine', 'IPT with dihydroartemisinin-piperaquine', 'dihydroartemisinin-piperaquine and risk of malaria following cessation']","['incidence of symptomatic malaria', 'severe adverse events', 'One death', 'adverse events', 'symptomatic malaria', 'incidence rate ratio [aIRR']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0241520', 'cui_str': 'Ugandans (ethnic group)'}, {'cui': 'C0481430', 'cui_str': 'HTLV-3 antibody negative'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0404843', 'cui_str': 'Viable pregnancy (finding)'}, {'cui': 'C0017504', 'cui_str': 'Fetal Maturity, Chronologic'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C4517615', 'cui_str': 'One hundred and eighty-three'}, {'cui': 'C0596012', 'cui_str': 'Does reach (finding)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0020006', 'cui_str': 'Hospitals, District'}, {'cui': 'C0443061', 'cui_str': 'Tororo (qualifier value)'}, {'cui': 'C0041573', 'cui_str': 'Republic of Uganda'}]","[{'cui': 'C0380193', 'cui_str': 'iodine-123-IPT'}, {'cui': 'C0058108', 'cui_str': 'quinghaosu, dihydro-'}, {'cui': 'C0071105', 'cui_str': ""Quinoline, 4,4'-(1,3-propanediyldi-4,1-piperazinediyl)bis(7-chloro-)""}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0024530', 'cui_str': 'Plasmodium Infections'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0024530', 'cui_str': 'Plasmodium Infections'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",191.0,0.351502,"incidence 1·1 episodes per person-year; aIRR 0·62, 0·40-0·95, p=0·028).","[{'ForeName': 'Mary K', 'Initials': 'MK', 'LastName': 'Muhindo', 'Affiliation': 'Infectious Diseases Research Collaboration, Kampala, Uganda. Electronic address: marymkakuru@gmail.com.'}, {'ForeName': 'Prasanna', 'Initials': 'P', 'LastName': 'Jagannathan', 'Affiliation': 'Department of Medicine, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Abel', 'Initials': 'A', 'LastName': 'Kakuru', 'Affiliation': 'Infectious Diseases Research Collaboration, Kampala, Uganda.'}, {'ForeName': 'Bishop', 'Initials': 'B', 'LastName': 'Opira', 'Affiliation': 'Infectious Diseases Research Collaboration, Kampala, Uganda.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Olwoch', 'Affiliation': 'Infectious Diseases Research Collaboration, Kampala, Uganda.'}, {'ForeName': 'Jaffer', 'Initials': 'J', 'LastName': 'Okiring', 'Affiliation': 'Infectious Diseases Research Collaboration, Kampala, Uganda.'}, {'ForeName': 'Noeline', 'Initials': 'N', 'LastName': 'Nalugo', 'Affiliation': 'Infectious Diseases Research Collaboration, Kampala, Uganda.'}, {'ForeName': 'Tamara D', 'Initials': 'TD', 'LastName': 'Clark', 'Affiliation': 'Department of Medicine, University of California, San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Theodore', 'Initials': 'T', 'LastName': 'Ruel', 'Affiliation': 'Department of Medicine, University of California, San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Edwin', 'Initials': 'E', 'LastName': 'Charlebois', 'Affiliation': 'Department of Medicine, University of California, San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Margaret E', 'Initials': 'ME', 'LastName': 'Feeney', 'Affiliation': 'Department of Medicine, University of California, San Francisco, San Francisco, CA, USA; Department of Pediatrics, University of California, San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Diane V', 'Initials': 'DV', 'LastName': 'Havlir', 'Affiliation': 'Department of Medicine, University of California, San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Grant', 'Initials': 'G', 'LastName': 'Dorsey', 'Affiliation': 'Department of Medicine, University of California, San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Moses R', 'Initials': 'MR', 'LastName': 'Kamya', 'Affiliation': 'Infectious Diseases Research Collaboration, Kampala, Uganda; School of Medicine, Makerere University College of Health Sciences, Kampala, Uganda.'}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(19)30299-3'] 1529,32048365,"The effect of saffron supplement on clinical outcomes and metabolic profiles in patients with active rheumatoid arthritis: A randomized, double-blind, placebo-controlled clinical trial.","Rheumatoid arthritis (RA) is a systemic autoimmune and inflammatory disease. Our study aimed to determine the effect of saffron supplement on clinical outcomes and metabolic profiles in patients with active RA. In this randomized, double-blind, placebo-controlled trial, 66 women older than 18 years old received 100 mg/day either saffron supplement in the intervention group (n = 33) or matched placebo in the placebo group (n = 33) for a period of 12 weeks. Sixty-one patients (30 in the control and 31 in the saffron group) remained for the final analysis. No adverse effects were reported by the patients. Saffron supplementation significantly decreased the number of tender (-1.38 ± 1.66 vs. 0.10 ± 0.40, p < .001) and swollen (-2.12 ± 2.34 vs. 0.63 ± 2.79, p < .001) joints, pain intensity based on visual analogue scale (-18.36 ± 15.07 vs. -2.33 ± 5.04), p < .001), and disease activity score (DAS28) (-0.75 ± 0.67 vs. 0.26 ± 0.77, p < .001) at the end of intervention between the two groups and in saffron group compared with baseline values. Physician Global Assessment (p = .002) and erythrocyte sedimentation rate were significantly improved after intervention (24.06 ± 12.66 vs. 32.00 ± 14.75, p = 0.028). High-sensitivity C-reactive protein reduced at the end of the intervention in the saffron group compared with baseline values (12.00 ± 7.40 vs. 8.82 ± 7.930, p = .004). Tumor necrosis factor alpha, interferon gamma, and malondialdehyde were decreased, and total antioxidant capacity were increased, but their differences between the two groups were not significant (p > .05). According to the results, saffron supplements could positively and significantly improve clinical outcomes in RA patients.",2020,"Physician Global Assessment (p = .002) and erythrocyte sedimentation rate were significantly improved after intervention (24.06 ± 12.66 vs. 32.00 ± 14.75, p = 0.028).","['66 women older than 18\u2009years old received', 'patients with active RA', 'patients with active rheumatoid arthritis']","['Saffron supplementation', 'placebo', '100\u2009mg/day either saffron supplement', 'saffron supplement']","['clinical outcomes', 'adverse effects', 'Tumor necrosis factor alpha, interferon gamma, and malondialdehyde', 'clinical outcomes and metabolic profiles', 'disease activity score (DAS28', 'total antioxidant capacity', 'High-sensitivity C-reactive protein', 'number of tender', 'erythrocyte sedimentation rate', 'Physician Global Assessment', 'pain intensity based on visual analogue scale']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid Arthritis'}]","[{'cui': 'C2348128', 'cui_str': 'Saffron'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0439422', 'cui_str': 'mg/day'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0021745', 'cui_str': 'interferon gamma'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C3853758', 'cui_str': 'Metabolic Profile'}, {'cui': 'C4706353', 'cui_str': 'Disease Activity Score'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0234234', 'cui_str': 'Tender (qualifier value)'}, {'cui': 'C1176468', 'cui_str': 'Erythrocyte sedimentation rate measurement'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}]",66.0,0.472196,"Physician Global Assessment (p = .002) and erythrocyte sedimentation rate were significantly improved after intervention (24.06 ± 12.66 vs. 32.00 ± 14.75, p = 0.028).","[{'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Hamidi', 'Affiliation': 'Department of Nutrition, School of Public Health, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Naheed', 'Initials': 'N', 'LastName': 'Aryaeian', 'Affiliation': 'Department of Nutrition, School of Public Health, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Jamileh', 'Initials': 'J', 'LastName': 'Abolghasemi', 'Affiliation': 'Department of Biostatistics, School of Public Health, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Shirani', 'Affiliation': 'Department of Internal Medicine, Faculty of Medicine, Rasoul-e-Akram Hospital, Tehran, Iran.'}, {'ForeName': 'Mahsa', 'Initials': 'M', 'LastName': 'Hadidi', 'Affiliation': 'Department of Nutrition, School of Public Health, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Soudabeh', 'Initials': 'S', 'LastName': 'Fallah', 'Affiliation': 'Department of Clinical Biochemistry, Faculty of Medicine, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Nariman', 'Initials': 'N', 'LastName': 'Moradi', 'Affiliation': 'Department of Clinical Biochemistry, Faculty of Medicine, Kurdistan University of Medical Sciences, Sanandaj, Iran.'}]",Phytotherapy research : PTR,['10.1002/ptr.6633'] 1530,32439503,Pressure-Support Ventilation vs T-Piece During Spontaneous Breathing Trials Before Extubation Among Patients at High Risk of Extubation Failure: A Post-Hoc Analysis of a Clinical Trial.,"BACKGROUND Spontaneous breathing trial (SBT) using a T-piece remains the most frequently performed trial before extubation in ICUs. RESEARCH QUESTION We aimed at determining whether initial SBT using pressure-support ventilation (PSV) could increase successful extubation rates among patients at high risk of extubation failure. STUDY DESIGN AND METHODS Post hoc analysis of a multicenter trial focusing on reintubation in patients at high-risk of extubation failure. The initial SBT was performed using PSV or T-piece according to the physician/center decision. The primary outcome was the proportion of patients successfully extubated 72 hours after initial SBT, that is, extubated after initial SBT and not reintubated within the following 72 hours. RESULTS Among the 641 patients included in the original study, initial SBT was performed using PSV (7.0 cm H 2 O in median without positive end-expiratory pressure) in 243 patients (38%) and using a T-piece in 398 patients (62%). The proportion of patients successfully extubated 72 hours after initial SBT was 67% (162/243) using PSV and 56% (223/398) using T-piece (absolute difference 10.6%; 95% CI, 2.8-28.1; P = .0076). The proportion of patients extubated after initial SBT was 77% (186/283) using PSV and 63% (249/398) using T-piece (P = .0002), whereas reintubation rates within the following 72 hours did not significantly differ (13% vs 10%, respectively; P = .4259). Performing an initial SBT using PSV was independently associated with successful extubation (adjusted OR, 1.60; 95% CI, 1.30-2.18; P = .0061). INTERPRETATION In patients at high risk of extubation failure in the ICU, performing an initial SBT using PSV may hasten extubation without an increased risk of reintubation.",2020,"Performing an initial SBT using PSV was independently associated with successful extubation (adjusted odds ratio 1.60, 95% CI 1.30 to 2.18; p=0.0061). ","['641 patients included in the original study, initial SBT', 'patients at high-risk of extubation failure']","['Pressure-support ventilation versus T-piece', 'SBT using pressure-support ventilation (PSV']","['successful extubation', 'successful extubation rates', 'proportion of patients extubated after initial SBT', 'proportion of patients successfully extubated 72h after initial SBT', 'proportion of patients successfully extubated 72h after initial SBT, i.e. extubated after initial SBT', 'reintubation rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205313', 'cui_str': 'Original'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C1828139', 'cui_str': 'Trial for spontaneous breathing'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0553891', 'cui_str': 'Extubation of trachea'}, {'cui': 'C0231174', 'cui_str': 'Failure'}]","[{'cui': 'C0419008', 'cui_str': 'Pressure support'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C1828139', 'cui_str': 'Trial for spontaneous breathing'}]","[{'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0553891', 'cui_str': 'Extubation of trachea'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C1828139', 'cui_str': 'Trial for spontaneous breathing'}, {'cui': 'C1292423', 'cui_str': '72 hours'}, {'cui': 'C0860359', 'cui_str': 'Reintubate'}]",641.0,0.20449,"Performing an initial SBT using PSV was independently associated with successful extubation (adjusted odds ratio 1.60, 95% CI 1.30 to 2.18; p=0.0061). ","[{'ForeName': 'Arnaud W', 'Initials': 'AW', 'LastName': 'Thille', 'Affiliation': ""Centre Hospitalier Universitaire de Poitiers, Médecine Intensive Réanimation, Poitiers, France; INSERM Centre d'Investigation Clinique 1402 ALIVE, Université de Poitiers, Poitiers, France. Electronic address: aw.thille@gmail.com.""}, {'ForeName': 'Rémi', 'Initials': 'R', 'LastName': 'Coudroy', 'Affiliation': ""Centre Hospitalier Universitaire de Poitiers, Médecine Intensive Réanimation, Poitiers, France; INSERM Centre d'Investigation Clinique 1402 ALIVE, Université de Poitiers, Poitiers, France.""}, {'ForeName': 'Mai-Anh', 'Initials': 'MA', 'LastName': 'Nay', 'Affiliation': ""Centre Hospitalier Régional d'Orléans, Médecine Intensive Réanimation, Orléans, France.""}, {'ForeName': 'Arnaud', 'Initials': 'A', 'LastName': 'Gacouin', 'Affiliation': 'Centre Hospitalier Universitaire de Rennes, Hôpital Ponchaillou, Service des Maladies Infectieuses et Réanimation Médicale, Rennes, France.'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Demoule', 'Affiliation': 'Hôpital Pitié-Salpêtrière, Service de Pneumologie, Médecine Intensive et Réanimation (Département R3S), UMRS1158 neurophysiologie respiratoire expérimentale et clinique, Sorbonne Université, Paris, France.'}, {'ForeName': 'Romain', 'Initials': 'R', 'LastName': 'Sonneville', 'Affiliation': 'Hôpital Bichat-Claude Bernard, Médecine Intensive Réanimation, Université Paris Diderot, Paris, France.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Beloncle', 'Affiliation': ""Centre Hospitalier Universitaire d'Angers, Département de Médecine Intensive Réanimation, Université d'Angers, Angers, France.""}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Girault', 'Affiliation': 'Centre Hospitalier Universitaire de Rouen, Hôpital Charles Nicolle, Département de Réanimation Médicale, Normandie Université, Institute for Research and Innovation in Biomedicine (IRIB), Rouen, France.'}, {'ForeName': 'Laurence', 'Initials': 'L', 'LastName': 'Dangers', 'Affiliation': 'Centre Hospitalier Universitaire Félix Guyon, Service de Réanimation Polyvalente, Saint Denis de la Réunion, France.'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Lautrette', 'Affiliation': 'Centre Hospitalier Universitaire de Clermont-Ferrand, Hôpital Gabriel Montpied, Service de Réanimation Médicale, Clermont-Ferrand, France.'}, {'ForeName': 'Quentin', 'Initials': 'Q', 'LastName': 'Levrat', 'Affiliation': 'Centre Hospitalier de La Rochelle, Service de Réanimation, La Rochelle, France.'}, {'ForeName': 'Anahita', 'Initials': 'A', 'LastName': 'Rouzé', 'Affiliation': 'Centre Hospitalier Universitaire de Lille, Centre de Réanimation, Université de Lille, Lille, France.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Vivier', 'Affiliation': 'Hôpital Saint-Joseph Saint-Luc, Réanimation Polyvalente, Lyon, France.'}, {'ForeName': 'Jean-Baptiste', 'Initials': 'JB', 'LastName': 'Lascarrou', 'Affiliation': 'Centre Hospitalier Universitaire de Nantes, Médecine Intensive Réanimation, Nantes, France.'}, {'ForeName': 'Jean-Damien', 'Initials': 'JD', 'LastName': 'Ricard', 'Affiliation': 'Hôpital Louis Mourier, Réanimation Médico-Chirurgicale, Université Paris Diderot, Sorbonne Paris Cité, Colombes, France.'}, {'ForeName': 'Keyvan', 'Initials': 'K', 'LastName': 'Razazi', 'Affiliation': 'Hôpitaux universitaires Henri Mondor, Service de Réanimation Médicale DHU A-TVB, Créteil, France.'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Barberet', 'Affiliation': 'Groupe Hospitalier Régional Mulhouse Sud Alsace, site Emile Muller, Service de Réanimation Médicale, Mulhouse, France.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Lebert', 'Affiliation': 'Centre Hospitalier Départemental de Vendée, Service de Médecine Intensive Réanimation, La Roche Sur Yon, France.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Ehrmann', 'Affiliation': ""Centre Hospitalier Régional Universitaire de Tours, Médecine Intensive Réanimation, Réseau CRICS-Trigger SEP, Centre d'étude des pathologies respiratoires, Université de Tours, Tours, France.""}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Massri', 'Affiliation': 'Centre Hospitalier de Pau, Service de Réanimation, Pau, France.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Bourenne', 'Affiliation': 'Centre Hospitalier Universitaire La Timone 2, Médecine Intensive Réanimation, Réanimation des Urgences, Aix-Marseille Université, Marseille, France.'}, {'ForeName': 'Gael', 'Initials': 'G', 'LastName': 'Pradel', 'Affiliation': ""Centre Hospitalier Henri Mondor d'Aurillac, Service de Réanimation, Aurillac, France.""}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Bailly', 'Affiliation': 'Centre Hospitalier Universitaire de Brest, Médecine Intensive Réanimation, Brest, France.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Terzi', 'Affiliation': 'Centre Hospitalier Universitaire Grenoble Alpes, Médecine Intensive Réanimation, INSERM, Université Grenoble-Alpes, Grenoble, France.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Dellamonica', 'Affiliation': ""Centre Hospitalier Universitaire de Nice, Médecine Intensive Réanimation, Archet 1, Université Cote d'Azur, Nice, France.""}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Lacave', 'Affiliation': 'Centre Hospitalier de Versailles, Service de Réanimation Médico-Chirurgicale, Le Chesnay, France.'}, {'ForeName': 'René', 'Initials': 'R', 'LastName': 'Robert', 'Affiliation': ""Centre Hospitalier Universitaire de Poitiers, Médecine Intensive Réanimation, Poitiers, France; INSERM Centre d'Investigation Clinique 1402 ALIVE, Université de Poitiers, Poitiers, France.""}, {'ForeName': 'Stéphanie', 'Initials': 'S', 'LastName': 'Ragot', 'Affiliation': ""INSERM Centre d'Investigation Clinique 1402 ALIVE, Université de Poitiers, Poitiers, France.""}, {'ForeName': 'Jean-Pierre', 'Initials': 'JP', 'LastName': 'Frat', 'Affiliation': ""Centre Hospitalier Universitaire de Poitiers, Médecine Intensive Réanimation, Poitiers, France; INSERM Centre d'Investigation Clinique 1402 ALIVE, Université de Poitiers, Poitiers, France.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Chest,['10.1016/j.chest.2020.04.053'] 1531,32439861,Physiological and Behavioral Synchrony Predict Group Cohesion and Performance.,"Interpersonal synchrony contributes to social functioning in dyads, but it remains unknown how synchrony shapes group experiences and performance. To this end, we designed a novel group drumming task in which participants matched their drumming to either predictable or unpredictable tempos. Fifty-one three-person groups were randomly assigned to one of two conditions: synchronized or asynchronized drumming. Outcome measures included electrocardiograms and self-reports of group cohesion and synchrony. The drumming task elicited an increase in physiological synchrony between group members (specifically their hearts' interbeat intervals). We also found that physiological synchronization and behavioral synchronization predicted individuals' experience of group cohesion. Physiological synchrony also predicted performance in a subsequent group task that involved freely drumming together. The findings suggest that the behavioral and physiological consequences of synchronization contribute to the formation of group bonds and coordination. They also confirm that insights from translational social neuroscience can inform our knowledge of the development of cohesive and efficacious groups.",2020,Physiological synchrony also predicted performance in a subsequent group task that involved freely drumming together.,"['participants matched their drumming to either predictable or unpredictable tempos', 'Fifty-one three-person groups']",['synchronized or asynchronized drumming'],"['electrocardiograms and self-reports of group cohesion and synchrony', 'physiological synchrony']","[{'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0439580', 'cui_str': 'Synchronous'}]","[{'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}]",,0.0139198,Physiological synchrony also predicted performance in a subsequent group task that involved freely drumming together.,"[{'ForeName': 'Ilanit', 'Initials': 'I', 'LastName': 'Gordon', 'Affiliation': 'Department of Psychology, Bar-Ilan University, Ramat-Gan, Israel. Ilanit.gordon@biu.ac.il.'}, {'ForeName': 'Avi', 'Initials': 'A', 'LastName': 'Gilboa', 'Affiliation': 'The Music Department, Bar Ilan University, Ramat-Gan, Israel.'}, {'ForeName': 'Shai', 'Initials': 'S', 'LastName': 'Cohen', 'Affiliation': 'The Music Department, Bar Ilan University, Ramat-Gan, Israel.'}, {'ForeName': 'Nir', 'Initials': 'N', 'LastName': 'Milstein', 'Affiliation': 'Department of Psychology, Bar-Ilan University, Ramat-Gan, Israel.'}, {'ForeName': 'Nir', 'Initials': 'N', 'LastName': 'Haimovich', 'Affiliation': 'Department of Psychology, Bar-Ilan University, Ramat-Gan, Israel.'}, {'ForeName': 'Shay', 'Initials': 'S', 'LastName': 'Pinhasi', 'Affiliation': 'The Psychology Department, Rupin College, Emeq-Hefer, Israel.'}, {'ForeName': 'Shahar', 'Initials': 'S', 'LastName': 'Siegman', 'Affiliation': 'The Department of Computer Science, Bar Ilan University, Ramat-Gan, Israel.'}]",Scientific reports,['10.1038/s41598-020-65670-1'] 1532,32440004,Arm-pull thrust in human swimming and the effect of post-activation potentiation.,"The aim of this study was to analyse the front-crawl arm-pull kinetics and kinematics, comparing it before and after post-activation potentiation (PAP), and the associations between variables describing of the arm-pull kinetics. Twelve male competitive swimmers were randomly assigned to perform two different warm-ups in a crossover manner: (i) non-PAP (control condition); and (ii) PAP (experimental condition). PAP consisted of 2 × 5 arm-pulls with resistance bands by both upper-limbs. Eight minutes later, participants underwent a 25 m all-out trial in front-crawl arm-pull. Kinetics (i.e., peak thrust, mean thrust and thrust-time integral) and kinematics (i.e., speed and speed fluctuation) were collected by an in-house customised system composed of differential pressure sensors, speedo-meter and underwater camera. There was a significant and large improvement of the arm-pull kinetics after completing the warm-up with PAP sets (0.010 < P < 0.054, 0.50 < d < 0.74). There were non-significant and small effects of PAP on speed (P = 0.307, d = 0.18) and speed fluctuation (P = 0.498, d = 0.04). Correlation coefficients among kinetic variables were significant with large associations (0.51 < R < 0.90, 0.001 < P < 0.088). In conclusion, warm-ups including PAP conditioning sets elicit a large improvement in the thrust, but with small improvement in performance. Variables used to characterise thrust are strongly correlated and hence can be used interchangeably.",2020,"There was a significant and large improvement of the arm-pull kinetics after completing the warm-up with PAP sets (0.010 < P < 0.054, 0.50 < d < 0.74).",['Twelve male competitive swimmers'],['crossover manner: (i) non-PAP (control condition); and (ii) PAP (experimental condition'],"['Kinetics (i.e., peak thrust, mean thrust and thrust-time integral) and kinematics (i.e., speed and speed fluctuation', 'arm-pull kinetics', 'speed fluctuation']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0450068', 'cui_str': 'Swimmer'}]","[{'cui': 'C0150097', 'cui_str': 'Crossover Trials'}, {'cui': 'C0429387', 'cui_str': 'Post-activation (tetanic) potentiation - finding'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0022702', 'cui_str': 'Kinetics'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0443238', 'cui_str': 'Integral'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0231239', 'cui_str': 'Fluctuation'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0580846', 'cui_str': 'Does pull'}]",12.0,0.0288481,"There was a significant and large improvement of the arm-pull kinetics after completing the warm-up with PAP sets (0.010 < P < 0.054, 0.50 < d < 0.74).","[{'ForeName': 'Tiago M', 'Initials': 'TM', 'LastName': 'Barbosa', 'Affiliation': 'Physical Education and Sport Science Academic Group, National Institute of Education, Nanyang Technological University, Singapore, Singapore. tiago.barbosa@nie.edu.sg.'}, {'ForeName': 'Jia Wen', 'Initials': 'JW', 'LastName': 'Yam', 'Affiliation': 'Physical Education and Sport Science Academic Group, National Institute of Education, Nanyang Technological University, Singapore, Singapore.'}, {'ForeName': 'Danny', 'Initials': 'D', 'LastName': 'Lum', 'Affiliation': 'Physical Education and Sport Science Academic Group, National Institute of Education, Nanyang Technological University, Singapore, Singapore.'}, {'ForeName': 'Govindasamy', 'Initials': 'G', 'LastName': 'Balasekaran', 'Affiliation': 'Physical Education and Sport Science Academic Group, National Institute of Education, Nanyang Technological University, Singapore, Singapore.'}, {'ForeName': 'Daniel A', 'Initials': 'DA', 'LastName': 'Marinho', 'Affiliation': 'Research Centre in Sports, Health and Human Development - CIDESD, Vila Real, Portugal.'}]",Scientific reports,['10.1038/s41598-020-65494-z'] 1533,31466693,"Development of a transdiagnostic, low-intensity, psychological intervention for common adolescent mental health problems in Indian secondary schools.","BACKGROUND The PRIDE programme aims to establish a suite of transdiagnostic psychological interventions organised around a stepped care system in Indian secondary schools. This paper describes the development of a low-intensity, first-line component of the PRIDE model. METHOD Contextual and global evidence informed an intervention 'blueprint' with problem solving as the primary practice element. Successive iterations were tested and modified across two pilot cohort studies (N = 45; N = 39). Participants were aged 13-20 years and presenting with elevated mental health symptoms in New Delhi schools. RESULTS The first iteration of the intervention, based on a guided self-help modality, showed promising outcomes and user satisfaction when delivered by psychologists. However, delivery was not feasible within the intended 6-week schedule, and participants struggled to use materials outside 'guidance' sessions. In Pilot 2, a modified counsellor-led problem-solving intervention was implemented by less experienced counsellors over a 3-4 week schedule. Outcomes were maintained, with indications of enhanced feasibility and acceptability. High demand was observed across both pilots, leading to more stringent eligibility criteria and a modified sensitisation plan. DISCUSSION Findings have shaped a first-line intervention for common adolescent mental health problems in low-resource settings. A forthcoming randomised controlled trial will test its effectiveness.",2020,"The first iteration of the intervention, based on a guided self-help modality, showed promising outcomes and user satisfaction when delivered by psychologists.","['Indian secondary schools', 'common adolescent mental health problems in Indian secondary schools', 'Participants were aged 13-20 years and presenting with elevated mental health symptoms in New Delhi schools']","['modified counsellor-led problem-solving intervention', 'transdiagnostic, low-intensity, psychological intervention']",[],"[{'cui': 'C1524069', 'cui_str': 'Indian (racial group)'}, {'cui': 'C0036530', 'cui_str': 'Schools, Secondary'}, {'cui': 'C0205214', 'cui_str': 'Common (qualifier value)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C1446377', 'cui_str': 'Mental health problem'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0036375', 'cui_str': 'School'}]","[{'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C3669643', 'cui_str': 'Problem solving (qualifier value)'}, {'cui': 'C0596836', 'cui_str': 'Low intensity'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}]",[],,0.0559856,"The first iteration of the intervention, based on a guided self-help modality, showed promising outcomes and user satisfaction when delivered by psychologists.","[{'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Michelson', 'Affiliation': 'School of Psychology, University of Sussex, Brighton, UK.'}, {'ForeName': 'Kanika', 'Initials': 'K', 'LastName': 'Malik', 'Affiliation': 'Sangath, Goa and New Delhi, India.'}, {'ForeName': 'Madhuri', 'Initials': 'M', 'LastName': 'Krishna', 'Affiliation': 'Sangath, Goa and New Delhi, India.'}, {'ForeName': 'Rhea', 'Initials': 'R', 'LastName': 'Sharma', 'Affiliation': 'Sangath, Goa and New Delhi, India.'}, {'ForeName': 'Sonal', 'Initials': 'S', 'LastName': 'Mathur', 'Affiliation': 'Sangath, Goa and New Delhi, India.'}, {'ForeName': 'Bhargav', 'Initials': 'B', 'LastName': 'Bhat', 'Affiliation': 'Sangath, Goa and New Delhi, India.'}, {'ForeName': 'Rachana', 'Initials': 'R', 'LastName': 'Parikh', 'Affiliation': 'Sangath, Goa and New Delhi, India; Department of Clinical Psychology, Vrije Universiteit, Amsterdam, Netherlands.'}, {'ForeName': 'Kallol', 'Initials': 'K', 'LastName': 'Roy', 'Affiliation': 'Shree Krishna Hospital, Gujarat, India.'}, {'ForeName': 'Akankasha', 'Initials': 'A', 'LastName': 'Joshi', 'Affiliation': 'Sangath, Goa and New Delhi, India.'}, {'ForeName': 'Rooplata', 'Initials': 'R', 'LastName': 'Sahu', 'Affiliation': 'Sangath, Goa and New Delhi, India.'}, {'ForeName': 'Bhagwant', 'Initials': 'B', 'LastName': 'Chilhate', 'Affiliation': 'Sangath, Goa and New Delhi, India.'}, {'ForeName': 'Maya', 'Initials': 'M', 'LastName': 'Boustani', 'Affiliation': 'Department of Psychology, Loma Linda University, Los Angeles, USA.'}, {'ForeName': 'Pim', 'Initials': 'P', 'LastName': 'Cuijpers', 'Affiliation': 'Department of Clinical Psychology, Vrije Universiteit, Amsterdam, Netherlands.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Chorpita', 'Affiliation': 'Department of Psychology, University of California at Los Angeles, Los Angeles, USA.'}, {'ForeName': 'Christopher G', 'Initials': 'CG', 'LastName': 'Fairburn', 'Affiliation': 'Department of Psychiatry, University of Oxford, Oxford, UK.'}, {'ForeName': 'Vikram', 'Initials': 'V', 'LastName': 'Patel', 'Affiliation': 'Sangath, Goa and New Delhi, India; Department of Global Health and Social Medicine, Harvard Medical School, Boston, USA; Harvard TH Chan School of Public Health, Boston, USA. Electronic address: Vikram_Patel@hms.harvard.edu.'}]",Behaviour research and therapy,['10.1016/j.brat.2019.103439'] 1534,31402321,"Neoadjuvant letrozole plus taselisib versus letrozole plus placebo in postmenopausal women with oestrogen receptor-positive, HER2-negative, early-stage breast cancer (LORELEI): a multicentre, randomised, double-blind, placebo-controlled, phase 2 trial.","BACKGROUND Endocrine therapy-based neoadjuvant treatment for luminal breast cancer allows efficient testing of new combinations before surgery. The activation of the phosphatidylinositol-3-kinase (PI3K) pathway is a known mechanism of resistance to endocrine therapy. Taselisib is an oral, selective PI3K inhibitor with enhanced activity against PIK3CA-mutant cancer cells. The LORELEI trial tested whether taselisib in combination with letrozole would result in an increased proportion of objective responses and pathological complete responses. METHODS In this multicentre, randomised, double-blind, parallel-cohort, placebo-controlled phase 2, study, we enrolled postmenopausal women (aged ≥18 years) with histologically confirmed, oestrogen receptor (ER)-positive, HER2-negative, stage I-III, operable breast cancer, from 85 hospitals in 22 countries worldwide. To be eligible, patients had have an Eastern Cooperative Oncology Group (ECOG) performance status 0-1, adequate organ function, and had to have evaluable tumour tissue for PIK3CA genotyping. Patients were randomly assigned (1:1) by means of a permuted block algorithm (block size of four) via an interactive voice or web-based response system, to receive letrozole (2·5 mg/day orally, continuously) with either 4 mg of oral taselisib or placebo (on a 5 days-on, 2 days-off schedule) for 16 weeks, followed by surgery. Randomisation was stratified by tumour size and nodal status. Site staff, patients, and the sponsor were masked to treatment assignment. Coprimary endpoints were the proportion of patients who achieved an objective response by centrally assessed breast MRI and a locally assessed pathological complete response in the breast and axilla (ypT0/Tis, ypN0) at surgery in all randomly assigned patients and in patients with PIK3CA-mutant tumours. Analyses were done in the intention-to-treat population. This trial is registered with ClinicalTrials.gov, number NCT02273973, and is closed to accrual. FINDINGS Between Nov 12, 2014, and Aug 12, 2016, 334 participants were enrolled and randomly assigned to receive letrozole and placebo (n=168) or letrozole and taselisib (n=166). Median follow-up was 4·9 months (IQR 4·7-5·1). The study met one of its primary endpoints: the addition of taselisib to letrozole was associated with a higher proportion of patients achieving an objective response in all randomly assigned patients (66 [39%] of 168 patients in the placebo group vs 83 [50%] of 166 in the taselisib group; odds ratio [OR] 1·55, 95% CI 1·00-2·38; p=0·049) and in the PIK3CA-mutant subset (30 [38%] of 79 vs 41 [56%] of 73; OR 2·03, 95% CI 1·06-3·88; p=0·033). No significant differences were observed in pathological complete response between the two groups, either in the overall population (three [2%] of 166 in the taselisib group vs one [1%] of 168 in the placebo group; OR 3·07 [95% CI 0·32-29·85], p=0·37) or in the PIK3CA-mutant cohort (one patient [1%) vs none [0%]; OR not estimable, p=0·48). The most common grade 3-4 adverse events in the taselisib group were gastrointestinal (13 [8%] of 167 patients), infections (eight [5%]), and skin-subcutaneous tissue disorders (eight [5%]). In the placebo group, four (2%) of 167 patients had grade 3 or worse vascular disorders, two (1%) had gastrointestinal disorders, and two (1%) patients had grade 3 or worse infections and infestations. There was no grade 4 hyperglycaemia and grade 3 cases were asymptomatic. Serious adverse events were more common in the taselisib group (eight [5%] patients with infections and seven [4%] with gastrointestinal effects) than in the placebo group (one [1%] patient each with grade 3 postoperative wound and haematoma infection, grade 4 hypertensive encephalopathy, grade 3 acute cardiac failure, and grade 3 breast pain). One death occurred in the taselisib group, which was not considered to be treatment-related. INTERPRETATION The increase in the proportion of patients who achieved an objective response from the addition of taselisib to endocrine therapy in a neoadjuvant setting is consistent with the clinical benefit observed in hormone receptor-positive, HER2-negative, metastatic breast cancer. FUNDING Genentech and F Hoffmann-La Roche.",2019,"No significant differences were observed in pathological complete response between the two groups, either in the overall population (three [2%] of 166 in the taselisib group vs one [1%] of 168 in the placebo group; OR 3·07 [95% CI 0·32-29·85], p=0·37) or in the PIK3CA-mutant cohort (one patient [1%) vs none [0%]; OR not estimable, p=0·48).","['postmenopausal women with oestrogen receptor-positive, HER2-negative, early-stage breast cancer (LORELEI', 'enrolled postmenopausal women (aged ≥18 years) with histologically confirmed, oestrogen receptor (ER)-positive, HER2-negative, stage I-III, operable breast cancer, from 85 hospitals in 22 countries worldwide', 'Between Nov 12, 2014, and Aug 12, 2016, 334 participants', 'patients had have an Eastern Cooperative Oncology Group (ECOG) performance status 0-1, adequate organ function, and had to have evaluable tumour tissue for PIK3CA genotyping']","['letrozole and placebo', 'placebo', 'Neoadjuvant letrozole plus taselisib versus letrozole plus placebo', 'letrozole', 'Endocrine therapy-based neoadjuvant treatment', 'letrozole and taselisib', 'permuted block algorithm (block size of four) via an interactive voice or web-based response system, to receive letrozole (2·5 mg/day orally, continuously) with either 4 mg of oral taselisib or placebo']","['grade 3 postoperative wound and haematoma infection, grade 4 hypertensive encephalopathy, grade 3 acute cardiac failure, and grade 3 breast pain', 'One death', 'objective response', 'grade 3 or worse infections and infestations', 'proportion of objective responses and pathological complete responses', 'Serious adverse events', 'pathological complete response', 'grade 3 or worse vascular disorders', 'gastrointestinal disorders', 'proportion of patients who achieved an objective response by centrally assessed breast MRI and a locally assessed pathological complete response in the breast and axilla (ypT0/Tis, ypN0', 'skin-subcutaneous tissue disorders']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0202006', 'cui_str': 'Estrogen measurement (procedure)'}, {'cui': 'C0597357', 'cui_str': 'Receptor (substance)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C4087376', 'cui_str': 'HER2 negative'}, {'cui': 'C2363430', 'cui_str': 'Early stage (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1 (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0205188', 'cui_str': 'Operable (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C4517729', 'cui_str': '334'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1520224', 'cui_str': 'Eastern Cooperative Oncology Group performance status'}, {'cui': 'C0205411', 'cui_str': 'Adequate (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0475358', 'cui_str': 'Tumor tissue sample (specimen)'}, {'cui': 'C1285573', 'cui_str': 'Genotype determination'}]","[{'cui': 'C0246421', 'cui_str': 'letrozole'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C4053731'}, {'cui': 'C0279025', 'cui_str': 'Hormone therapy (procedure)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant Treatment'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0002045'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0439422', 'cui_str': 'mg/day'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}]","[{'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0948087', 'cui_str': 'Haematoma infection'}, {'cui': 'C0151620', 'cui_str': 'Hypertensive Encephalopathy'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0024902', 'cui_str': 'Mammalgia'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0009450', 'cui_str': 'Infectious Diseases'}, {'cui': 'C1521733', 'cui_str': 'Pathologic (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0042373', 'cui_str': 'Vascular Diseases'}, {'cui': 'C0017178', 'cui_str': 'Gastrointestinal Diseases'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0006141', 'cui_str': 'Breast'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C0004454', 'cui_str': 'Axilla'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0278403', 'cui_str': 'Tela Subcutanea'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]",334.0,0.665998,"No significant differences were observed in pathological complete response between the two groups, either in the overall population (three [2%] of 166 in the taselisib group vs one [1%] of 168 in the placebo group; OR 3·07 [95% CI 0·32-29·85], p=0·37) or in the PIK3CA-mutant cohort (one patient [1%) vs none [0%]; OR not estimable, p=0·48).","[{'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Saura', 'Affiliation': ""Vall d'Hebrón University Hospital, Vall d'Hebrón Institute of Oncology, Barcelona, Spain; SOLTI Breast Cancer Research Group, Barcelona, Spain. Electronic address: csaura@vhio.net.""}, {'ForeName': 'Dominik', 'Initials': 'D', 'LastName': 'Hlauschek', 'Affiliation': 'Austrian Breast and Colorectal Cancer Study Group, Vienna, Austria.'}, {'ForeName': 'Mafalda', 'Initials': 'M', 'LastName': 'Oliveira', 'Affiliation': ""Vall d'Hebrón University Hospital, Vall d'Hebrón Institute of Oncology, Barcelona, Spain; SOLTI Breast Cancer Research Group, Barcelona, Spain.""}, {'ForeName': 'Dimitrios', 'Initials': 'D', 'LastName': 'Zardavas', 'Affiliation': 'Bristol-Myers Squibb Company, Lawrence, NJ, USA.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Jallitsch-Halper', 'Affiliation': 'Austrian Breast and Colorectal Cancer Study Group, Vienna, Austria.'}, {'ForeName': 'Lorena', 'Initials': 'L', 'LastName': 'de la Peña', 'Affiliation': 'SOLTI Breast Cancer Research Group, Barcelona, Spain.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Nuciforo', 'Affiliation': ""Vall d'Hebrón University Hospital, Vall d'Hebrón Institute of Oncology, Barcelona, Spain; SOLTI Breast Cancer Research Group, Barcelona, Spain.""}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Ballestrero', 'Affiliation': 'University of Genoa - Istituto di Ricovero e Cura a Carattere Scientifico, Ospedale Policlinico San Martino, Genova; Gruppo Oncologico Italiano di Ricerca Clinica, Genova, Italy.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Dubsky', 'Affiliation': 'Medical University of Vienna, Vienna, Austria; Hirslanden Klinik St Anna, Breast Centre, Lucerne, Switzerland.'}, {'ForeName': 'Janine M', 'Initials': 'JM', 'LastName': 'Lombard', 'Affiliation': 'Breast Cancer Trials Australia New Zealand, University of Newcastle, Newcastle, NSW, Australia.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Vuylsteke', 'Affiliation': 'European Organisation for Research and Treatment of Cancer, Breast Cancer Group, CHU Namur, Université Catholique de Louvain, Ottignies-Nouvain-la-Neuve, Belgium.'}, {'ForeName': 'Carlos A', 'Initials': 'CA', 'LastName': 'Castaneda', 'Affiliation': 'Grupo de Estudios Clinicos Oncologicos Peruano, Lima, Perú.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Colleoni', 'Affiliation': 'Division of Medical Senology, European Institute of Oncology, Istituto di Ricovero e Cura a Carattere Scientifico and International Breast Cancer Study Group, Milan, Italy.'}, {'ForeName': 'Giuliano', 'Initials': 'G', 'LastName': 'Santos Borges', 'Affiliation': 'Centro de Novos Tratamentos Itajaí, Itajaí, Brazil.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Ciruelos', 'Affiliation': 'SOLTI Breast Cancer Research Group, Barcelona, Spain; Hospital Universitario 12 de Octubre, Madrid, Spain.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Fornier', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, Weill Cornell Medical College, New York, NY, USA.'}, {'ForeName': 'Katalin', 'Initials': 'K', 'LastName': 'Boer', 'Affiliation': 'Szent Margit Hospital, Budapest, Hungary.'}, {'ForeName': 'Aditya', 'Initials': 'A', 'LastName': 'Bardia', 'Affiliation': 'Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Timothy R', 'Initials': 'TR', 'LastName': 'Wilson', 'Affiliation': 'Genentech Inc, South San Francisco, CA, USA.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Stout', 'Affiliation': 'Genentech Inc, South San Francisco, CA, USA.'}, {'ForeName': 'Jerry Y', 'Initials': 'JY', 'LastName': 'Hsu', 'Affiliation': 'Genentech Inc, South San Francisco, CA, USA.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Shi', 'Affiliation': 'Genentech Inc, South San Francisco, CA, USA.'}, {'ForeName': 'Martine', 'Initials': 'M', 'LastName': 'Piccart', 'Affiliation': 'Breast International Group, Brussels, Belgium; Institut Jules Bordet, Université Libre de Bruxelles, Brussels, Belgium.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Gnant', 'Affiliation': 'Austrian Breast and Colorectal Cancer Study Group, Vienna, Austria; Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Baselga', 'Affiliation': 'AstraZeneca, Gaithersburg, Maryland, USA.'}, {'ForeName': 'Evandro', 'Initials': 'E', 'LastName': 'de Azambuja', 'Affiliation': 'Institut Jules Bordet, Université Libre de Bruxelles, Brussels, Belgium.'}]",The Lancet. Oncology,['10.1016/S1470-2045(19)30334-1'] 1535,31479804,Laser-assisted MAL-PDT associated with acoustic pressure wave ultrasound with short incubation time for field cancerization treatment: A left-right comparison.,"BACKGROUND Laser-assisted MAL-PDT has been reported to increase the effectiveness of conventional PDT. Nonetheless, clinical effects of this association when reducing MAL incubation time is poorly discussed. Furthermore, the association of acoustic pressure wave ultrasound with laser-assisted MAL-PDT with short incubation time for field cancerization had not been reported before. OBJECTIVES To compare clinical effects of ablative fractional laser-assisted MAL-PDT associated with acoustic pressure wave ultrasound (IMPACT US) with 1-hour incubation time and conventional MAL-PDT for skin field cancerization on the forearms, as well as the impact on safety and tolerability. METHODS Fifteen patients with 638 AK (grade I-III) with field cancerized-skin on the forearms were enrolled in this left-right trial. Two protocols were randomly chosen. One side was treated with conventional MAL-PDT, whereas the other with laser-assisted MAL-PDT associated with acoustic pressure wave ultrasound with 1-hour incubation time. Actinic keratoses were quantitively measured, and the other signs of sun-damaged skin, like pigmentation and texture, in field cancerized skin were qualitatively evaluated before and after six months. Side effects were assessed subjectively during the procedure and one week after. RESULTS All patients completed the study. At six months after treatment, both protocols reduced the number of AK (72%; CO2 + PDT, and 65%; MAL-PDT). The difference between these two protocols was not statistically significant (p = 0.77). The improvement of pigmentation and texture of field cancerized skin was more significant on the side treated with laser-assisted MAL-PDT associated with acoustic pressure wave ultrasound. Both protocols were well tolerated and without significant difference in adverse events. CONCLUSION Laser-assisted MAL-PDT using CO2 laser and acoustic pressure wave ultrasound with short incubation time of 1 h was as effective as conventional MAL-PDT for field-cancerized skin with actinic keratosis in forearms with better cosmetic outcome.",2019,The improvement of pigmentation and texture of field cancerized skin was more significant on the side treated with laser-assisted MAL-PDT associated with acoustic pressure wave ultrasound.,['Fifteen patients with 638 AK (grade I-III) with field cancerized-skin on the forearms were enrolled in this left-right trial'],"['Laser-assisted MAL-PDT', 'conventional MAL-PDT', 'Laser-assisted MAL-PDT using CO2 laser and acoustic pressure wave ultrasound', 'ablative fractional laser-assisted MAL-PDT associated with acoustic pressure wave ultrasound (IMPACT US']","['safety and tolerability', 'pigmentation and texture of field cancerized skin', 'adverse events', 'MAL incubation time', 'Side effects', 'Actinic keratoses', 'number of AK']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0440042', 'cui_str': ""Field's""}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0016536', 'cui_str': 'Antebrachiums'}, {'cui': 'C0205090', 'cui_str': 'Right (qualifier value)'}]","[{'cui': 'C0023089', 'cui_str': 'Lasers'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0044588', 'cui_str': 'PDT'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0392251', 'cui_str': 'CO2 Lasers'}, {'cui': 'C0001166', 'cui_str': 'Acoustics'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0332281', 'cui_str': 'Associated with (attribute)'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031911', 'cui_str': 'Pigmentation'}, {'cui': 'C0449582', 'cui_str': 'With texture (attribute)'}, {'cui': 'C0440042', 'cui_str': ""Field's""}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0022602', 'cui_str': 'Senile keratoma (disorder)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}]",,0.0165927,The improvement of pigmentation and texture of field cancerized skin was more significant on the side treated with laser-assisted MAL-PDT associated with acoustic pressure wave ultrasound.,"[{'ForeName': 'M T F', 'Initials': 'MTF', 'LastName': 'Pires', 'Affiliation': 'Fluminense Federal University, Professor, Faculdade de Medicina Souza Marques, Niterói, Rio de Janeiro, Brazil.'}, {'ForeName': 'A D', 'Initials': 'AD', 'LastName': 'Pereira', 'Affiliation': 'Fluminense Federal University, Niterói, Rio de Janeiro, Brazil.'}, {'ForeName': 'S M B', 'Initials': 'SMB', 'LastName': 'Durães', 'Affiliation': 'Fluminense Federal University, Niterói, Rio de Janeiro, Brazil.'}, {'ForeName': 'M C A', 'Initials': 'MCA', 'LastName': 'Issa', 'Affiliation': 'Fluminense Federal University, Niterói, Rio de Janeiro, Brazil.'}, {'ForeName': 'Marianna', 'Initials': 'M', 'LastName': 'Pires', 'Affiliation': 'Av. Das Américas, 3500 Bl.7 Sl.234, 22640-105, Rio de Janeiro, Brazil. Electronic address: marianna.pires@gmail.com.'}]",Photodiagnosis and photodynamic therapy,['10.1016/j.pdpdt.2019.08.034'] 1536,31462859,One-year follow-up study to evaluate the marginal bone resorption and attachment loss with customized post with stud attachment and prefabricated access post for mandibular overdenture.,"Aim This study aims to analyze the marginal bone resorption and attachment loss of the overdenture attachment for the mandibular overdenture. Settings and Design Observational study done at MGV's KBH Dental College and Hospital, Nashik, Maharashtra, India. Materials and Methods A total of 30 subjects were selected of either sex between the age group of 50-70 years by designate of randomized parallel controlled sampling technique. The Cone beam computed tomography (CBCT) radiographic quantification determines the caliber of bone resorption and University of North Carolina (UNC) probe checked the depth of attachment loss of the abutment teeth that receive the cast coping (nonattachment control group), customized post and stud attachment, and prefabricated access post. Statistical Analysis Used Oneway ANOVA test and post hoc Bonferroni multiple test. Results statistical analysis reveals the comparison of distinction between groups is significant at P < 0.05. The control group records least bone resorption and attachment loss than Group II and Group I. However, Group II records marginally higher bone resorption and attachment loss than Group III. Conclusion The result of the study within the physiologic limit analyze that, cast coping records least bone resorption and attachment loss followed by Customized post with stud attachment and prefabricated access posts. The prefabricated access post records higher bone resorption and attachment loss.",2019,The control group records least bone resorption and attachment loss than Group II and Group I.,"['30 subjects were selected of either sex between the age group of 50-70 years by designate of randomized parallel controlled sampling technique', ""MGV's KBH Dental College and Hospital, Nashik, Maharashtra, India""]",['Cone beam computed tomography (CBCT) radiographic quantification'],"['marginal bone resorption and attachment loss', 'bone resorption and attachment loss']","[{'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0027362', 'cui_str': 'Age Groups'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C4522313', 'cui_str': 'Dental (intended site)'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0021201', 'cui_str': 'Republic of India'}]","[{'cui': 'C1956110', 'cui_str': 'Cone-Beam Computerized Tomography'}, {'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}]","[{'cui': 'C0205284', 'cui_str': 'Marginal (qualifier value)'}, {'cui': 'C0005974', 'cui_str': 'Osteoclastic Bone Loss'}, {'cui': 'C0185023', 'cui_str': 'pexy'}]",30.0,0.0266621,The control group records least bone resorption and attachment loss than Group II and Group I.,"[{'ForeName': 'Sachin Haribhau', 'Initials': 'SH', 'LastName': 'Chaware', 'Affiliation': ""Department of Prosthodontics and Crown and Bridge, MGV's KBH Dental College and Hospital, Nashik, Maharashtra, India.""}, {'ForeName': 'Vibhuti Rohit', 'Initials': 'VR', 'LastName': 'Sachdev', 'Affiliation': ""Department of Prosthodontics and Crown and Bridge, MGV's KBH Dental College and Hospital, Nashik, Maharashtra, India.""}]",Journal of Indian Prosthodontic Society,['10.4103/jips.jips_91_19'] 1537,31462863,Comparative analysis of shear bond strength of lithium disilicate samples cemented using different resin cement systems: An in vitro study.,"Aim This study aims to evaluate and compare the shear bond strength (SBS) of three different resin cements - total etch and rinse, self-etch and self-adhesive resin cements, used to bond the lithium disilicate restorations to human dentin. Settings and Design Comparative - Invitro study design. Materials and Methods Forty-five lithium disilicate (IPS E.max) discs (4 mm in diameter and 3 mm thick) were fabricated and randomly divided into three groups ( n = 15). The occlusal surfaces of 45 extracted human maxillary premolars were ground flat. Fifteen specimens were luted, under a constant load, with each of the following resin cement: Variolink N (Group VN), Multilink N (Group MN), and Multilink Speed (Group MS). All cemented specimens were stored in distilled water for 1-week following which, they were tested under shear loading at a constant crosshead speed of 1 mm/min until fracture on a universal testing machine; the load at fracture was reported in megapascals (MPa) as the bond strength. Fractured specimens were also inspected by the scanning electron microscopy. Statistical analysis of the collected data was performed using one-way ANOVA test, post hoc Bonferroni test, and Chi-square test (α =0.05). Statistical Analysis Used Oneway ANOVA test and post hoc Bonferroni test. Results Mean SBS data of the groups in MPa were: Variolink N (Group VN): 14.19 ± 0.76; Multilink N (Group MN): 10.702 ± 0.75; and Multilink Speed (Group MS): 5.462 ± 0.66. Significant differences in SBS ( P < 0.001) of the three resin cement were found. Intergroup comparison revealed statistically significant differences in SBS between Groups VN and MN ( P < 0.001), Groups B and C ( P < 0.001), and Groups VN and MS ( P < 0.001). Chi-square test used to compare the distribution of mode of bond failure among the three groups delineated that the cohesive failure was significantly more among Group VN, whereas adhesive failure was significantly more among Group MN and MS. Conclusion Total etch and rinse resin cement, i.e., Variolink N (Group VN) produced significantly higher bond strength of all-ceramics to dentin surfaces than did the self-etch and self-adhesive resin cements, i.e., Multilink N and Multilink Speed, respectively.",2019,"Intergroup comparison revealed statistically significant differences in SBS between Groups VN and MN ( P < 0.001), Groups B and C ( P < 0.001), and Groups VN and MS ( P < 0.001).","['Materials and Methods\n\n\nForty-five lithium disilicate (IPS E.max) discs (4 mm in diameter and 3 mm thick', '45 extracted human maxillary premolars were ground flat']","['resin cement: Variolink N (Group VN), Multilink N (Group MN), and Multilink Speed (Group MS', 'lithium disilicate samples cemented using different resin cement systems']","['adhesive failure', 'distribution of mode of bond failure', 'bond strength of all-ceramics to dentin surfaces', 'shear bond strength (SBS', 'SBS', 'Mean SBS data']","[{'cui': 'C0520510', 'cui_str': 'Material (attribute)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C1528812', 'cui_str': 'lithia disilicate'}, {'cui': 'C1705370', 'cui_str': 'Disc - unit of product usage'}, {'cui': 'C1301886', 'cui_str': 'Diameter (qualifier value)'}, {'cui': 'C1280412', 'cui_str': 'Thick (qualifier value)'}, {'cui': 'C2752151', 'cui_str': 'Extract (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C1704302', 'cui_str': 'Premolar'}, {'cui': 'C0185051', 'cui_str': 'Removal by grinding (procedure)'}, {'cui': 'C0205324', 'cui_str': 'Flat (qualifier value)'}]","[{'cui': 'C0376523', 'cui_str': 'Resin Cements'}, {'cui': 'C0534004', 'cui_str': 'Variolink'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1528812', 'cui_str': 'lithia disilicate'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C1704479', 'cui_str': 'Cement'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}]","[{'cui': 'C0001516', 'cui_str': 'Adhesives'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0037775', 'cui_str': 'Distributions (qualifier value)'}, {'cui': 'C0028758', 'cui_str': 'Object Relationship'}, {'cui': 'C0007742', 'cui_str': 'Ceramics'}, {'cui': 'C0011429', 'cui_str': 'Dentin'}, {'cui': 'C0205148', 'cui_str': 'Surface (attribute)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",45.0,0.0250615,"Intergroup comparison revealed statistically significant differences in SBS between Groups VN and MN ( P < 0.001), Groups B and C ( P < 0.001), and Groups VN and MS ( P < 0.001).","[{'ForeName': 'Viram', 'Initials': 'V', 'LastName': 'Upadhyaya', 'Affiliation': 'Department of Prosthodontics, DAV (C) Dental College, Yamuna Nagar, Haryana, India.'}, {'ForeName': 'Aman', 'Initials': 'A', 'LastName': 'Arora', 'Affiliation': 'Department of Prosthodontics, DAV (C) Dental College, Yamuna Nagar, Haryana, India.'}, {'ForeName': 'Jagriti', 'Initials': 'J', 'LastName': 'Singhal', 'Affiliation': 'Department of Prosthodontics, DAV (C) Dental College, Yamuna Nagar, Haryana, India.'}, {'ForeName': 'Smriti', 'Initials': 'S', 'LastName': 'Kapur', 'Affiliation': 'Department of Prosthodontics, DAV (C) Dental College, Yamuna Nagar, Haryana, India.'}, {'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Sehgal', 'Affiliation': 'Department of Prosthodontics, DAV (C) Dental College, Yamuna Nagar, Haryana, India.'}]",Journal of Indian Prosthodontic Society,['10.4103/jips.jips_161_19'] 1538,32000790,Effects of robot therapy on upper body kinematics and arm function in persons post stroke: a pilot randomized controlled trial.,"BACKGROUND Robot-based rehabilitation for persons post-stroke may improve arm function and daily-life activities as measured by clinical scales, but its effects on motor strategies during functional tasks are still poorly investigated. This study aimed at assessing the effects of robot-therapy versus arm-specific physiotherapy in persons post-stroke on motor strategies derived from upper body instrumented kinematic analysis, and on arm function measured by clinical scales. METHODS Forty persons in the sub-acute and chronic stage post-stroke were recruited. This sample included all those subjects, enrolled in a larger bi-center study, who underwent instrumented kinematic analysis and who were randomized in Center 2 into Robot (R_Group) and Control Group (C_Group). R_Group received robot-assisted training. C_Group received arm-specific treatment delivered by a physiotherapist. Pre- and post-training assessment included clinical scales and instrumented kinematic analysis of arm and trunk during a virtual untrained task simulating the transport of an object onto a shelf. Instrumented outcomes included shoulder/elbow coordination, elbow extension and trunk sagittal compensation. Clinical outcomes included Fugl-Meyer Motor Assessment of Upper Extremity (FM-UE), modified Ashworth Scale (MAS) and Functional Independence Measure (FIM). RESULTS R_Group showed larger post-training improvements of shoulder/elbow coordination (Cohen's d = - 0.81, p = 0.019), elbow extension (Cohen's d = - 0.71, p = 0.038), and trunk movement (Cohen's d = - 1.12, p = 0.002). Both groups showed comparable improvements in clinical scales, except proximal muscles MAS that decreased more in R_Group (Cohen's d = - 0.83, p = 0.018). Ancillary analyses on chronic subjects confirmed these results and revealed larger improvements after robot-therapy in the proximal portion of FM-UE (Cohen's d = 1.16, p = 0.019). CONCLUSIONS Robot-assisted rehabilitation was as effective as arm-specific physiotherapy in reducing arm impairment (FM-UE) in persons post-stroke, but it was more effective in improving motor control strategies adopted during an untrained task involving vertical movements not practiced during training. Specifically, robot therapy induced larger improvements of shoulder/elbow coordination and greater reduction of abnormal trunk sagittal movements. The beneficial effects of robot therapy seemed more pronounced in chronic subjects. Future studies on a larger sample should be performed to corroborate present findings. TRIAL REGISTRATION www.ClinicalTrials.gov NCT03530358. Registered 21 May 2018. Retrospectively registered.",2020,"CONCLUSIONS Robot-assisted rehabilitation was as effective as arm-specific physiotherapy in reducing arm impairment (FM-UE) in persons post-stroke, but it was more effective in improving motor control strategies adopted during an untrained task involving vertical movements not practiced during training.","['chronic subjects', 'Forty persons in the sub-acute and chronic stage post-stroke were recruited', 'persons post stroke', 'This sample included all those subjects, enrolled in a larger bi-center study, who underwent instrumented kinematic analysis and who were randomized in Center 2 into', 'persons post-stroke']","['Robot (R_Group) and Control Group (C_Group', 'Robot-assisted rehabilitation', 'Pre- and post-training assessment included clinical scales and instrumented kinematic analysis of arm and trunk during a virtual untrained task simulating the transport of an object onto a shelf', 'robot-therapy versus arm-specific physiotherapy', 'robot-assisted training', 'robot therapy']","['abnormal trunk sagittal movements', 'shoulder/elbow coordination', 'elbow extension', 'larger post-training improvements of shoulder/elbow coordination', 'Fugl-Meyer Motor Assessment of Upper Extremity (FM-UE), modified Ashworth Scale (MAS) and Functional Independence Measure (FIM', 'upper body kinematics and arm function', 'trunk movement', 'clinical scales, except proximal muscles MAS', 'shoulder/elbow coordination, elbow extension and trunk sagittal compensation']","[{'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C1264637', 'cui_str': 'Substance amount'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C4551823', 'cui_str': 'instruments'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}, {'cui': 'C1524024', 'cui_str': 'analysis'}]","[{'cui': 'C0336537', 'cui_str': 'Robot, device (physical object)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C4551823', 'cui_str': 'instruments'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0460005', 'cui_str': 'Torso'}, {'cui': 'C1317949', 'cui_str': 'Transport (physical object)'}, {'cui': 'C0347997', 'cui_str': 'Physical object'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}]","[{'cui': 'C0205161', 'cui_str': 'Abnormal (qualifier value)'}, {'cui': 'C0460005', 'cui_str': 'Torso'}, {'cui': 'C0205129', 'cui_str': 'Sagittal (qualifier value)'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0037004', 'cui_str': 'Shoulder'}, {'cui': 'C0013769', 'cui_str': 'Elbow'}, {'cui': 'C0242414', 'cui_str': 'Coordination (observable entity)'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C4707572', 'cui_str': 'Modified Ashworth Scale (assessment scale)'}, {'cui': 'C0451172', 'cui_str': 'Functional independence measure (assessment scale)'}, {'cui': 'C1268087', 'cui_str': 'Upper body'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0205107', 'cui_str': 'Proximal (qualifier value)'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0152058', 'cui_str': 'Compensation (finding)'}]",,0.0963772,"CONCLUSIONS Robot-assisted rehabilitation was as effective as arm-specific physiotherapy in reducing arm impairment (FM-UE) in persons post-stroke, but it was more effective in improving motor control strategies adopted during an untrained task involving vertical movements not practiced during training.","[{'ForeName': 'Ilaria', 'Initials': 'I', 'LastName': 'Carpinella', 'Affiliation': 'IRCCS Fondazione Don Carlo Gnocchi, via Capecelatro 66, 20148, Milan, Italy.'}, {'ForeName': 'Tiziana', 'Initials': 'T', 'LastName': 'Lencioni', 'Affiliation': 'IRCCS Fondazione Don Carlo Gnocchi, via Capecelatro 66, 20148, Milan, Italy. tlencioni@dongnocchi.it.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Bowman', 'Affiliation': 'IRCCS Fondazione Don Carlo Gnocchi, via Capecelatro 66, 20148, Milan, Italy.'}, {'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Bertoni', 'Affiliation': 'IRCCS Fondazione Don Carlo Gnocchi, via Capecelatro 66, 20148, Milan, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Turolla', 'Affiliation': 'Movement Neuroscience Research Group, IRCCS San Camillo Hospital, Via Alberoni 70, 30126, Venezia, Lido, Italy.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Ferrarin', 'Affiliation': 'IRCCS Fondazione Don Carlo Gnocchi, via Capecelatro 66, 20148, Milan, Italy.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Jonsdottir', 'Affiliation': 'IRCCS Fondazione Don Carlo Gnocchi, via Capecelatro 66, 20148, Milan, Italy.'}]",Journal of neuroengineering and rehabilitation,['10.1186/s12984-020-0646-1'] 1539,31991511,"Efficacy of vibegron, a novel β3-adrenoreceptor agonist, on severe urgency urinary incontinence related to overactive bladder: post hoc analysis of a randomized, placebo-controlled, double-blind, comparative phase 3 study.","OBJECTIVE To evaluate the efficacy of a novel and selective β3-adrenoreceptor agonist vibegron on urgency urinary incontinence (UUI) in patients with overactive bladder (OAB). PATIENTS AND METHODS A post hoc analysis was performed in patients with UUI (>0 episodes/day) who were assigned to receive vibegron or placebo in a vibegron phase 3 study. Patients were subclassified into mild/moderate (>0 to <3 UUI episodes/day) or severe UUI (≥3 UUI episodes/day) subgroup. Changes from baseline in number of UUI episodes/day, in number of urgency episodes/day, and in voided volume/micturition were compared between the groups. The percentage of patients who became UUI-free ('diary-dry' rate) and the response rate (percentage of patients with scores 1 [feeling much better] or 2 [feeling better] assessed by the Patient Global Impression scale [PGI]) were evaluated. RESULTS Changes in numbers of UUI episodes at week 12 in the vibegron 50 mg, vibegron 100 mg and placebo groups, respectively, were -1.35, -1.47 and -1.08 in all patients, -1.04, -1.13 and -0.89 in the mild/moderate UUI subgroup, and -2.95, -3.28 and -2.10 in the severe UUI subgroup. The changes were significant in the vibegron 50 and 100 mg groups vs placebo regardless of symptom severity. Change in number of urgency episodes/day was significant in the vibegron 100 mg group vs placebo in all patients and in both severity subgroups. In the vibegron 50 mg group, a significant change vs placebo was observed in all patients and in the mild/moderate UUI subgroup. Change in voided volume/micturition was significantly greater in the vibegron 50 and 100 mg groups vs placebo in all patients, as well as in the both severity subgroups. Diary-dry rates in the vibegron 50 and 100 mg groups were significantly greater vs placebo in all patients and in the mild/moderate UUI subgroup. In the severe UUI subgroup, however, a significant difference was observed only in the vibegron 50 mg group. Response rates assessed by the PGI were significantly higher in the vibegron groups vs placebo in all patients and in the both severity subgroups. Vibegron administration, OAB duration ≤37 months, mean number of micturitions/day at baseline <12.0 and mean number of UUI episodes/day at baseline <3.0 were identified as factors significantly associated with normalization of UUI. CONCLUSIONS Vibegron, a novel β3-adrenoreceptor agonist, significantly reduced the number of UUI episodes/day and significantly increased the voided volume/micturition in patients with OAB including those with severe UUI, with the response rate exceeding 50%. These results suggest that vibegron can be an effective therapeutic option for OAB patients with UUI.",2020,Change in voided volume/micturition was significantly greater in the vibegron 50 mg and 100 mg groups versus placebo in all patients as well as in the both severity subgroups.,"['Patients were subclassified into mild-moderate (>0 to <3 UUI episodes/d) or severe UUI (≥3 UUI episodes/d) subgroup', 'in the vibegron phase 3 study and had UUI episodes ', 'OAB patients', 'severe urgency urinary incontinence related to overactive bladder', 'OAB patients with UUI']","['novel and selective β3-adrenoreceptor agonist vibegron', 'vibegron, a novel β3-adrenoreceptor agonist', 'placebo', 'vibegron or placebo']","['number of UUI episodes', 'response rate', 'Response rates assessed by PGI', 'Diary-dry rate', 'numbers of UUI episodes', 'feeling much better] or 2 [feeling better] assessed by Patient Global Impression', 'urgency urinary incontinence (UUI', 'Change in voided volume/micturition', 'voided volume/micturition', 'number of UUI episodes/d, number of urgency episodes/d, and voided volume/micturition', 'Diary-dry rates']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C4279743', 'cui_str': 'vibegron'}, {'cui': 'C0439561', 'cui_str': 'Phase 3 (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439609', 'cui_str': 'Urgency (qualifier value)'}, {'cui': 'C0042024', 'cui_str': 'Urinary Incontinence'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0878773', 'cui_str': 'Overactive Bladder'}]","[{'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C4279743', 'cui_str': 'vibegron'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0376660', 'cui_str': 'Diary'}, {'cui': 'C0205222', 'cui_str': 'Dry (qualifier value)'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C3841449', 'cui_str': 'Much better (qualifier value)'}, {'cui': 'C0332272', 'cui_str': 'Better (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0439609', 'cui_str': 'Urgency (qualifier value)'}, {'cui': 'C0042024', 'cui_str': 'Urinary Incontinence'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0042034', 'cui_str': 'Micturition'}]",,0.155688,Change in voided volume/micturition was significantly greater in the vibegron 50 mg and 100 mg groups versus placebo in all patients as well as in the both severity subgroups.,"[{'ForeName': 'Masaki', 'Initials': 'M', 'LastName': 'Yoshida', 'Affiliation': 'Department of Urology, National Centre for Geriatrics and Gerontology, Obu, Japan.'}, {'ForeName': 'Masayuki', 'Initials': 'M', 'LastName': 'Takeda', 'Affiliation': 'Department of Urology, University of Yamanashi, Graduate School of Medical Sciences, Kofu, Japan.'}, {'ForeName': 'Momokazu', 'Initials': 'M', 'LastName': 'Gotoh', 'Affiliation': 'Department of Urology, Nagoya University Graduate School of Medicine, Nagoya, Japan.'}, {'ForeName': 'Osamu', 'Initials': 'O', 'LastName': 'Yokoyama', 'Affiliation': 'Department of Urology, Faculty of Medical Science, University of Fukui, Fukui, Japan.'}, {'ForeName': 'Hidehiro', 'Initials': 'H', 'LastName': 'Kakizaki', 'Affiliation': 'Department of Renal and Urological Surgery, Asahikawa Medical University, Asahikawa, Japan.'}, {'ForeName': 'Satoru', 'Initials': 'S', 'LastName': 'Takahashi', 'Affiliation': 'Department of Urology, Nihon University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Naoya', 'Initials': 'N', 'LastName': 'Masumori', 'Affiliation': 'Department of Urology, Sapporo Medical University School of Medicine, Sapporo, Japan.'}, {'ForeName': 'Shinji', 'Initials': 'S', 'LastName': 'Nagai', 'Affiliation': 'Kyorin Pharmaceutical Co., Ltd., Tokyo, Japan.'}, {'ForeName': 'Kazuyoshi', 'Initials': 'K', 'LastName': 'Minemura', 'Affiliation': 'Kyorin Pharmaceutical Co., Ltd., Tokyo, Japan.'}]",BJU international,['10.1111/bju.15020'] 1540,31984620,Exposure-response relationships for the sodium-glucose co-transporter-2 inhibitor dapagliflozin with regard to renal risk markers.,"AIMS To quantitate the consistency of an individual's plasma exposure to dapagliflozin upon re-exposure, and to investigate whether the individual's systemic exposure to dapagliflozin explains inter-individual variation in response to dapagliflozin with regard to multiple renal risk markers. METHODS Data were used from a crossover randomized clinical trial that assessed the albuminuria-lowering effect of dapagliflozin in 33 people with type 2 diabetes and elevated albuminuria. Fifteen participants were exposed twice to dapagliflozin. Trough plasma concentrations of dapagliflozin were measured for each participant at steady state. Dapagliflozin plasma concentrations were measured by liquid chromatography tandem mass spectrometry, and pharmacokinetic characteristics were simulated based on a population pharmacokinetic model. Linear mixed-effects models were used to quantify the exposure-response relationships. RESULTS The median plasma concentration after first and second exposure to dapagliflozin was 5.3 ng/mL vs 4.6 ng/mL, respectively (P = 0.78). Lin's concordance correlation coefficient between occasions was 0.73 (P < 0.0021). Every 100 ng.h/mL increment in area under the dapagliflozin plasma concentration curve was associated with a decrease in log-transformed urinary albumin:creatinine ratio (β = -5.9, P < 0.01), body weight (β = -0.3, P < 0.01) and estimated glomerular filtration rate (β = -0.7, P = 0.01) and an increase in urinary glucose excretion (β = 17.0, P < 0.001). CONCLUSION An individual's exposure to dapagliflozin is consistent upon re-exposure and correlates with pharmacodynamic response in renal risk markers.",2020,"RESULTS Median plasma concentration after first and second exposure to dapagliflozin was 5.3 ng/ml vs 4.6 ng/ml respectively (p=0.78).",['33 patients with type 2 diabetes and elevated albuminuria'],"['dapagliflozin', 'sodium-glucose co-transporter 2 inhibitor dapagliflozin', 'Dapagliflozin']","['dapagliflozin plasma concentration curve', 'renal risk markers', 'eGFR', 'body weight', 'log transformed urinary albumin:creatinine ratio', 'Trough plasma concentrations of dapagliflozin', 'Median plasma concentration', 'Dapagliflozin plasma concentrations']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0001925', 'cui_str': 'Albuminuria'}]","[{'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C4301634', 'cui_str': 'Sodium-glucose co-transporter 2 (SGLT2) inhibitors'}]","[{'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C3711292', 'cui_str': '68Ga-albumin'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0444506', 'cui_str': 'Trough (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]",33.0,0.075259,"RESULTS Median plasma concentration after first and second exposure to dapagliflozin was 5.3 ng/ml vs 4.6 ng/ml respectively (p=0.78).","[{'ForeName': 'Marjolein Y A M', 'Initials': 'MYAM', 'LastName': 'Kroonen', 'Affiliation': 'Department of Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Centre Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Jeroen V', 'Initials': 'JV', 'LastName': 'Koomen', 'Affiliation': 'Department of Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Centre Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Sergei I', 'Initials': 'SI', 'LastName': 'Petrykiv', 'Affiliation': 'Department of Psychiatric and Mental Healthcare, West Noord Brabant, The Netherlands.'}, {'ForeName': 'Gozewijn D', 'Initials': 'GD', 'LastName': 'Laverman', 'Affiliation': 'Department of Nephrology, Ziekenhuis Groep Twente, Almelo and Hengelo, The Netherlands.'}, {'ForeName': 'Hiddo J L', 'Initials': 'HJL', 'LastName': 'Heerspink', 'Affiliation': 'Department of Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Centre Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Jasper', 'Initials': 'J', 'LastName': 'Stevens', 'Affiliation': ''}]","Diabetes, obesity & metabolism",['10.1111/dom.13976'] 1541,32440111,Effect of Gender on Lung Function and Patient-Reported Outcomes in Patients with COPD Receiving Nebulized Glycopyrrolate.,"Purpose The clinical manifestation of COPD can differ by gender, with women experiencing worse lung function and health-related quality of life than men. Additionally, women tend to report more symptoms given the same disease severity. Accordingly, the impact of gender on efficacy and safety in patients with moderate-to-very-severe COPD was examined following 12 weeks of nebulized glycopyrrolate (GLY) 25 µg twice daily (BID) or placebo. Patients and Methods GLY and placebo pooled data from the replicate 12-week GOLDEN 3 and 4 studies (n=861) were grouped by gender. Endpoints reported were change from baseline in trough forced expiratory volume in 1 second (FEV 1 ), St George's Respiratory Questionnaire (SGRQ) and EXAcerbations of COPD Tool-Respiratory Symptoms (EXACT-RS) total scores. Safety was evaluated by reviewing the incidence of adverse events (AEs) and serious AEs. Results Men (placebo: 54.7%; GLY: 56.1%) were generally older with a greater proportion of high cardiovascular risk and use of background long-acting β 2 -agonists or inhaled corticosteroids. GLY treatment resulted in significant, clinically important improvements in trough FEV 1 , regardless of gender. Patients treated with GLY reported significant improvements in SGRQ total score, irrespective of gender; however, the improvement was numerically higher in women. Although EXACT-RS improved in both genders, only women experienced a significant improvement. Overall, GLY was well tolerated with a numerically lower incidence of AEs in men than women. Conclusion Treatment with nebulized GLY resulted in lung function, SGRQ total score, and EXACT-RS total score improvements regardless of gender. However, only EXACT-RS showed significantly greater improvements in women compared with men. Treatment with GLY was generally well tolerated across genders. These data support the efficacy and safety of GLY 25 µg BID in patients with moderate-to-very-severe COPD, independent of gender. Gender similarities in airflow improvement and differences in symptom-reporting augment the evidence supporting the consideration of individualized treatment plans for COPD patients.",2020,"Patients treated with GLY reported significant improvements in SGRQ total score, irrespective of gender; however, the improvement was numerically higher in women.","['women experiencing worse lung function and health-related quality of life than men', 'Patients with COPD Receiving', 'men than women', 'patients with moderate-to-very-severe COPD', 'GLY: 56.1%) were generally older with a greater proportion of high cardiovascular risk and use of background long-acting β 2 -agonists or inhaled corticosteroids', 'COPD patients']","['nebulized GLY', 'nebulized glycopyrrolate (GLY', 'Nebulized Glycopyrrolate', 'placebo']","['SGRQ total score', 'incidence of adverse events (AEs) and serious AEs', 'lung function, SGRQ total score, and EXACT-RS total score', 'efficacy and safety', ""trough forced expiratory volume in 1 second (FEV 1 ), St George's Respiratory Questionnaire (SGRQ) and EXAcerbations of COPD Tool-Respiratory Symptoms (EXACT-RS) total scores"", 'Lung Function']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C3641272', 'cui_str': 'Very severe'}, {'cui': 'C0017970', 'cui_str': 'Glycopyrrolate'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}]","[{'cui': 'C0017970', 'cui_str': 'Glycopyrrolate'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0037090', 'cui_str': 'Respiratory symptom'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444506', 'cui_str': 'Trough'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}]",861.0,0.103846,"Patients treated with GLY reported significant improvements in SGRQ total score, irrespective of gender; however, the improvement was numerically higher in women.","[{'ForeName': 'Jill A', 'Initials': 'JA', 'LastName': 'Ohar', 'Affiliation': 'Department of Internal Medicine, Wake Forest University, Winston-Salem, NC, USA.'}, {'ForeName': 'Ayca', 'Initials': 'A', 'LastName': 'Ozol-Godfrey', 'Affiliation': 'Sunovion Pharmaceuticals Inc., Marlborough, MA, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Goodin', 'Affiliation': 'Sunovion Pharmaceuticals Inc., Marlborough, MA, USA.'}, {'ForeName': 'Shahin', 'Initials': 'S', 'LastName': 'Sanjar', 'Affiliation': 'Sunovion Pharmaceuticals Inc., Marlborough, MA, USA.'}]",International journal of chronic obstructive pulmonary disease,['10.2147/COPD.S240303'] 1542,32440638,"Anemia and Micronutrient Status during Pregnancy, and Their Associations with Obstetric and Infant Outcomes among HIV-Infected Ugandan Women Receiving Antiretroviral Therapy.","Background Women living with HIV (WLHIV) are at higher risk of micronutrient deficiencies and adverse health outcomes. There are limited data on the burden or sequelae of micronutrient deficiencies among pregnant WLHIV receiving antiretroviral therapy (ART). Objectives We aimed to examine anemia and vitamin B-12, folate, and vitamin D deficiencies, and their associations with obstetric and infant outcomes, among pregnant WLHIV initiating combination antiretroviral therapy (cART) in rural Uganda. Methods This was a prospective analysis among pregnant WLHIV (12-28 weeks of gestation) in PROMOTE-Pregnant Women and Infants (PIs), a randomized trial comparing the effects of protease inhibitor (PI)-based ART with those of a non-PI-based ART on placental malaria risk. We conducted a substudy on the burden of anemia [trimester 1/3: hemoglobin (Hb) <11.0 g/dL; trimester 2: Hb <10.5 g/dL; n  = 367] and micronutrient deficiencies ( n  = 127) in pregnant WLHIV and their associations with obstetric and infant outcomes. Hb was measured by cyanmethemoglobin, vitamin B-12 and folate were measured via electrochemiluminescence, and vitamin D was measured by ELISA. Linear and binomial regression were used to evaluate associations between micronutrient status during pregnancy and perinatal outcomes. Results 26.8% women were anemic, 30.2% were vitamin B-12 insufficient (<221.0 pmol/L), 66.1% were folate insufficient (<13.5 nmol/L), and 65.4% were vitamin D insufficient (<30.0 ng/mL) at enrollment. Anemia during pregnancy was associated with a greater risk of small for gestational age (SGA) (RR: 1.88; 95% CI: 1.28, 2.77; P  = 0.001); each 1-g/dL decrease in Hb was associated with greater risk of SGA (RR: 0.76; 95% CI: 0.65, 0.90; P  = 0.001). Multivariate models showed that increased vitamin D concentrations predicted lower risk of infant wasting (WLZ < -2; RR: 0.94; 95% CI: 0.89, 0.99; P  = 0.04). Multivariate models also indicated that maternal vitamin B-12 and folate concentrations at enrollment predicted maternal ( P  < 0.001) and infant ( P  = 0.02) concentrations postpartum. Conclusions Anemia and micronutrient deficiencies are associated with a variety of adverse obstetric and infant outcomes and are an important public health concern in perinatal WLHIV on cART and their children.This trial was registered at clinicaltrials.gov as NCT00993031.",2020,"Anemia during pregnancy was associated with a greater risk of small for gestational age (SGA) (RR: 1.88; 95% CI: 1.28, 2.77; P  = 0.001); each 1-g/dL decrease in Hb was associated with greater risk of SGA (RR: 0.76; 95% CI: 0.65, 0.90; P  = 0.001).","['anemia [trimester 1/3: hemoglobin (Hb)\xa0<11.0 g/dL; trimester 2', 'pregnant WLHIV receiving antiretroviral therapy (ART', 'pregnant WLHIV (12-28 weeks of gestation) in PROMOTE-Pregnant Women and Infants (PIs', 'HIV-Infected Ugandan Women Receiving Antiretroviral Therapy', '\n\n\nWomen living with HIV (WLHIV']","['protease inhibitor (PI)-based ART with those of a non-PI-based ART', 'pregnant WLHIV initiating combination antiretroviral therapy (cART']","['cyanmethemoglobin, vitamin B-12 and folate were measured via electrochemiluminescence, and vitamin D', 'maternal vitamin B-12 and folate concentrations', 'Anemia']","[{'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0032982', 'cui_str': 'Trimesters'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0439267', 'cui_str': 'g/dL'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}]","[{'cui': 'C0033607', 'cui_str': 'Peptide hydrolase inhibitor'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}]","[{'cui': 'C0056663', 'cui_str': 'Cyanmethemoglobin'}, {'cui': 'C0042845', 'cui_str': 'Vitamin B 12'}, {'cui': 'C0178638', 'cui_str': 'Folate'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}]",367.0,0.327726,"Anemia during pregnancy was associated with a greater risk of small for gestational age (SGA) (RR: 1.88; 95% CI: 1.28, 2.77; P  = 0.001); each 1-g/dL decrease in Hb was associated with greater risk of SGA (RR: 0.76; 95% CI: 0.65, 0.90; P  = 0.001).","[{'ForeName': 'Julia L', 'Initials': 'JL', 'LastName': 'Finkelstein', 'Affiliation': 'Division of Nutritional Sciences, Cornell University, Ithaca, NY, USA.'}, {'ForeName': 'Heather S', 'Initials': 'HS', 'LastName': 'Herman', 'Affiliation': 'Division of Nutritional Sciences, Cornell University, Ithaca, NY, USA.'}, {'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Plenty', 'Affiliation': 'Center for AIDS Prevention Studies, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Saurabh', 'Initials': 'S', 'LastName': 'Mehta', 'Affiliation': 'Division of Nutritional Sciences, Cornell University, Ithaca, NY, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Natureeba', 'Affiliation': 'Infectious Diseases Research Collaboration, Kampala, Uganda.'}, {'ForeName': 'Tamara D', 'Initials': 'TD', 'LastName': 'Clark', 'Affiliation': 'Department of Medicine, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Moses R', 'Initials': 'MR', 'LastName': 'Kamya', 'Affiliation': 'Infectious Diseases Research Collaboration, Kampala, Uganda.'}, {'ForeName': 'Theodore', 'Initials': 'T', 'LastName': 'Ruel', 'Affiliation': ""Division of Infectious Disease, Department of Pediatrics, UCSF Benioff Children's Hospital, University of California San Francisco, San Francisco, CA, USA.""}, {'ForeName': 'Edwin D', 'Initials': 'ED', 'LastName': 'Charlebois', 'Affiliation': 'Center for AIDS Prevention Studies, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Cohan', 'Affiliation': 'Department of Obstetrics and Gynecology, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Havlir', 'Affiliation': 'Department of Medicine, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Sera L', 'Initials': 'SL', 'LastName': 'Young', 'Affiliation': 'Department of Anthropology and Global Health Studies, Northwestern University, Evanston, IL, USA.'}]",Current developments in nutrition,['10.1093/cdn/nzaa075'] 1543,11055317,"Secondary prevention in child health: effects of psychological intervention, particularly home visitation, on children's development and other outcome variables.","This paper reviews interventions targeting socially deprived families, families with low birthweight/premature children, and some other problems (child abuse, sensitivity/attachment, postnatal depression). Conclusions are mainly based on randomized controlled trials. Earlier reviews in the field have emphasized the importance of intensive, enduring home visitation and of early education programmes for young children. Home visitation may positively effect several outcomes, including health behaviour, child safety and stimulation. Rates of child abuse and neglect have proven difficult to influence, but home visitation may result in other gains such as fewer accidents and serious injuries, and greater home safety. The cognitive development of low birthweight and premature children may be positively influenced by home visitation, particularly in combination with an early stimulation programme in the neonatal unit and pre-school placement. Postnatally depressed mothers have been shown to improve substantially from nurse counselling once a week for 6-8 wk. It is suggested that home visitation should be tried on a systematic basis, and that early pre-school experiences should be offered to children in different risk situations. Child Health Centres should introduce a screening programme for postnatal depression. Specialist child health units should be encouraged.",2000,"The cognitive development of low birthweight and premature children may be positively influenced by home visitation, particularly in combination with an early stimulation programme in the neonatal unit and pre-school placement.","['young children', 'socially deprived families, families with low birthweight/premature children', 'child health']",['psychological intervention'],"['health behaviour, child safety and stimulation']","[{'cui': 'C0337547', 'cui_str': 'Younger child (person)'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0205252', 'cui_str': 'Immature (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0008078', 'cui_str': 'Childrens Health'}]","[{'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}]",,0.0217573,"The cognitive development of low birthweight and premature children may be positively influenced by home visitation, particularly in combination with an early stimulation programme in the neonatal unit and pre-school placement.","[{'ForeName': 'D', 'Initials': 'D', 'LastName': 'Lagerberg', 'Affiliation': 'Department of Paediatrics, University Hospital, Uppsala, Sweden.'}]","Acta paediatrica (Oslo, Norway : 1992). Supplement",[] 1544,31483889,Standing-type magnetically guided capsule endoscopy versus gastroscopy for gastric examination: multicenter blinded comparative trial.,"AIM To compare feasibility and safety after gastrointestinal checkup by standing-type magnetically controlled capsule endoscopy (SMCE) and conventional gastroscopy. METHODS This was a prospective multicenter, blinded study that compared SMCE with gastroscopy in patients from April 2018 to July 2018. All patients first underwent SMCE and then subsequently had gastroscopy with i.v. anesthesia. We calculated the compliance rates of gastric lesion detection by SMCE using gastroscopy as the standard. Capsule retention rate, incidence of adverse events, and patient satisfaction were documented throughout the study. RESULTS One hundred and sixty-one patients who completed SMCE and gastroscopy were included in the analysis. Positive compliance rate among SMCE and gastroscopy was 92.0% (95% CI: 80.77%-97.78%). Negative compliance rate was 95.5% (89.80%, 98.52%). Moreover, overall compliance rate was 94.41% (89.65%, 97.41%). Sixty-four pathological outcomes were identified. Of these 64 outcomes, 50 were detected by both procedures. The gastroscopy method neglected seven findings (such as five erosions, one polyp, and one ulcer). Furthermore, SMCE also overlooked seven lesions (i.e. one erosion, two polyps, one atrophy, and three submucosal tumors). Capsule retention or related adverse events were not reported. CONCLUSION Standing-type magnetically controlled capsule endoscopy provides equivalent agreement with gastroscopy and may be useful for screening of gastric illnesses without any anesthesia.",2020,The positive compliance rate among SMCE and gastroscopy was 92.0% (95%CI 80.77%-97.78%).,"['161 patients who completed the SMCE and gastroscopy were included in the analysis', 'patients for the duration of April 2018 to July 2018']","['Standing-type magnetically guided capsule endoscopy versus gastroscopy', 'gastroscopy with intravenous anesthesia', 'SMCE', 'gastrointestinal checkup by standing-type magnetically controlled capsule endoscopy (SMCE) and conventional gastroscopy', 'SMCE with gastroscopy']","['negative compliance rate', 'Capsule retention or related adverse events', 'capsule retention rate, incidence of adverse events, and patient satisfaction', 'feasibility and safety', 'positive compliance rate', 'overall compliance rate']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0017195', 'cui_str': 'Gastroscopy'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C2926735', 'cui_str': 'Duration'}]","[{'cui': 'C3888057', 'cui_str': 'Stand'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C1721048', 'cui_str': 'Video Capsule Endoscopy'}, {'cui': 'C0017195', 'cui_str': 'Gastroscopy'}, {'cui': 'C0002920', 'cui_str': 'Anesthesia, Intravenous'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}]","[{'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C4319574', 'cui_str': 'Capsule'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",64.0,0.102923,The positive compliance rate among SMCE and gastroscopy was 92.0% (95%CI 80.77%-97.78%).,"[{'ForeName': 'Hua-Sheng', 'Initials': 'HS', 'LastName': 'Lai', 'Affiliation': 'Guangdong Provincial Key Laboratory of Gastroenterology, Department of Gastroenterology, Nanfang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Xin-Ke', 'Initials': 'XK', 'LastName': 'Wang', 'Affiliation': 'Guangdong Provincial Key Laboratory of Gastroenterology, Department of Gastroenterology, Nanfang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Jian-Qun', 'Initials': 'JQ', 'LastName': 'Cai', 'Affiliation': 'Guangdong Provincial Key Laboratory of Gastroenterology, Department of Gastroenterology, Nanfang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Xin-Mei', 'Initials': 'XM', 'LastName': 'Zhao', 'Affiliation': 'Guangdong Provincial Key Laboratory of Gastroenterology, Department of Gastroenterology, Nanfang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Ze-Long', 'Initials': 'ZL', 'LastName': 'Han', 'Affiliation': 'Guangdong Provincial Key Laboratory of Gastroenterology, Department of Gastroenterology, Nanfang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Guangdong Provincial Key Laboratory of Gastroenterology, Department of Gastroenterology, Nanfang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Zhen-Yu', 'Initials': 'ZY', 'LastName': 'Chen', 'Affiliation': 'Guangdong Provincial Key Laboratory of Gastroenterology, Department of Gastroenterology, Nanfang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Zhi-Zhao', 'Initials': 'ZZ', 'LastName': 'Lin', 'Affiliation': 'Guangdong Provincial Key Laboratory of Gastroenterology, Department of Gastroenterology, Nanfang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Ping-Hong', 'Initials': 'PH', 'LastName': 'Zhou', 'Affiliation': 'Department of Gastroenterology, Zhongshan Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Bing', 'Initials': 'B', 'LastName': 'Hu', 'Affiliation': 'Department of Gastroenterology, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Ai-Min', 'Initials': 'AM', 'LastName': 'Li', 'Affiliation': 'Guangdong Provincial Key Laboratory of Gastroenterology, Department of Gastroenterology, Nanfang Hospital, Southern Medical University, Guangzhou, China.'}, {'ForeName': 'Si-de', 'Initials': 'SD', 'LastName': 'Liu', 'Affiliation': 'Guangdong Provincial Key Laboratory of Gastroenterology, Department of Gastroenterology, Nanfang Hospital, Southern Medical University, Guangzhou, China.'}]",Digestive endoscopy : official journal of the Japan Gastroenterological Endoscopy Society,['10.1111/den.13520'] 1545,31462629,Enzyme-treated orange pomace alters acute glycemic response to orange juice.,"The goal of the present study was to determine the impact of the addition of enzyme-treated orange pomace to orange juice on postprandial glycemic response. Ten healthy subjects (aged 27.9 ± 7.7 years, body mass index 22.1 ± 1.1 kg m -2 ) participated in a randomized, 2-arm, cross-over clinical trial to test the glycemic response to 100% orange juice (OJ) or 100% orange juice with 5 g of enzyme-treated orange pomace fiber (OPF). Blood samples were collected and glucose and insulin concentrations were measured at fasting (0 min) and every 15 min for 2 h after consuming the study juice products. Analysis of the 2 h incremental area under the curve (iAUC 0-2h ) indicated a significant reduction in blood glucose after ingesting the OPF juice compared to the OJ, p = 0.02. Peak glucose concentrations were also lowered after the OPF juice compared to the OJ, p < 0.05. No significant difference was observed in insulin responses between treatments, p > 0.05. Overall, this study demonstrated that adding 5 g of fiber from orange pomace into a serving of OJ attenuated the postprandial glucose response.",2019,"Peak glucose concentrations were also lowered after the OPF juice compared to the OJ, p < 0.05.","['Ten healthy subjects (aged 27.9\u2009±\u20097.7 years, body mass index 22.1\u2009±\u20091.1\u2009kg\u2009m -2 ']","['enzyme-treated orange pomace to orange juice', 'glycemic response to 100% orange juice (OJ) or 100% orange juice with 5\u2009g of enzyme-treated orange pomace fiber (OPF', 'Enzyme-treated orange pomace']","['blood glucose', 'postprandial glucose response', 'Peak glucose concentrations', 'postprandial glycemic response', 'glucose and insulin concentrations', 'insulin responses']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517860', 'cui_str': '7.7 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517491', 'cui_str': 'One point one'}, {'cui': 'C1532718', 'cui_str': 'kg-m'}]","[{'cui': 'C3541394', 'cui_str': 'Enzymes'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0440277', 'cui_str': 'Oranges'}, {'cui': 'C0452458', 'cui_str': 'Orange juice'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0225326', 'cui_str': 'Fiber'}]","[{'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C1287281', 'cui_str': 'Finding of glucose concentration, dipstick (finding)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",10.0,0.0276964,"Peak glucose concentrations were also lowered after the OPF juice compared to the OJ, p < 0.05.","[{'ForeName': 'Yancui', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': 'Center for Nutrition Research, Department of Food Science and Nutrition/Institute for Food Safety and Health, Illinois Institute of Technology, Chicago, IL, USA.'}, {'ForeName': 'Eunyoung', 'Initials': 'E', 'LastName': 'Park', 'Affiliation': 'Center for Nutrition Research, Department of Food Science and Nutrition/Institute for Food Safety and Health, Illinois Institute of Technology, Chicago, IL, USA.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Replogle', 'Affiliation': 'PepsiCo R&D, Chicago, IL, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Boileau', 'Affiliation': 'PepsiCo R&D, Chicago, IL, USA.'}, {'ForeName': 'Jin-E', 'Initials': 'JE', 'LastName': 'Shin', 'Affiliation': 'PepsiCo R&D, Chicago, IL, USA.'}, {'ForeName': 'Britt M', 'Initials': 'BM', 'LastName': 'Burton-Freeman', 'Affiliation': 'Center for Nutrition Research, Department of Food Science and Nutrition/Institute for Food Safety and Health, Illinois Institute of Technology, Chicago, IL, USA.'}, {'ForeName': 'Indika', 'Initials': 'I', 'LastName': 'Edirisinghe', 'Affiliation': 'Center for Nutrition Research, Department of Food Science and Nutrition/Institute for Food Safety and Health, Illinois Institute of Technology, Chicago, IL, USA. iedirisi@iit.edu.'}]",Nutrition & diabetes,['10.1038/s41387-019-0091-z'] 1546,31462766,Reward related ventral striatal activity and differential response to sertraline versus placebo in depressed individuals.,"Medications to treat major depressive disorder (MDD) are not equally effective across patients. Given that neural response to rewards is altered in MDD and given that reward-related circuitry is modulated by dopamine and serotonin, we examined, for the first time, whether reward-related neural activity moderated response to sertraline, an antidepressant medication that targets these neurotransmitters. A total of 222 unmedicated adults with MDD randomized to receive sertraline (n = 110) or placebo (n = 112) in the Establishing Moderators and Biosignatures of Antidepressant Response in Clinical Care (EMBARC) study completed demographic and clinical assessments, and pretreatment functional magnetic resonance imaging while performing a reward task. We tested whether an index of reward system function in the ventral striatum (VS), a key reward circuitry region, moderated differential response to sertraline versus placebo, assessed with the Hamilton Rating Scale for Depression (HSRD) over 8 weeks. We observed a significant moderation effect of the reward index, reflecting the temporal dynamics of VS activity, on week-8 depression levels (Fs ≥ 9.67, ps ≤ 0.002). Specifically, VS responses that were abnormal with respect to predictions from reinforcement learning theory were associated with lower week-8 depression symptoms in the sertraline versus placebo arms. Thus, a more abnormal pattern of pretreatment VS dynamic response to reward expectancy (expected outcome value) and prediction error (difference between expected and actual outcome), likely reflecting serotonergic and dopaminergic deficits, was associated with better response to sertraline than placebo. Pretreatment measures of reward-related VS activity may serve as objective neural markers to advance efforts to personalize interventions by guiding individual-level choice of antidepressant treatment.",2020,"Specifically, VS responses that were abnormal with respect to predictions from reinforcement learning theory were associated with lower week-8 depression symptoms in the sertraline versus placebo arms.","['depressed individuals', '222 unmedicated adults with MDD randomized to receive']","['placebo (n\u2009=\u2009112) in the Establishing Moderators and Biosignatures of Antidepressant Response in Clinical Care (EMBARC) study completed demographic and clinical assessments, and pretreatment functional magnetic resonance imaging while performing a reward task', 'sertraline', 'placebo', 'sertraline versus placebo']","['Hamilton Rating Scale for Depression (HSRD', 'depression symptoms']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0443211', 'cui_str': 'Established (qualifier value)'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant Drugs'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0376335', 'cui_str': 'fMRI'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0035397', 'cui_str': 'Rewards'}, {'cui': 'C0074393', 'cui_str': 'Sertraline'}]","[{'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression (assessment scale)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",222.0,0.129786,"Specifically, VS responses that were abnormal with respect to predictions from reinforcement learning theory were associated with lower week-8 depression symptoms in the sertraline versus placebo arms.","[{'ForeName': 'Tsafrir', 'Initials': 'T', 'LastName': 'Greenberg', 'Affiliation': 'Department of Psychiatry, School of Medicine, University of Pittsburgh, Pittsburgh, PA, USA. greenbergt@upmc.edu.'}, {'ForeName': 'Jay C', 'Initials': 'JC', 'LastName': 'Fournier', 'Affiliation': 'Department of Psychiatry, School of Medicine, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Richelle', 'Initials': 'R', 'LastName': 'Stiffler', 'Affiliation': 'Department of Psychiatry, School of Medicine, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Henry W', 'Initials': 'HW', 'LastName': 'Chase', 'Affiliation': 'Department of Psychiatry, School of Medicine, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Jorge R', 'Initials': 'JR', 'LastName': 'Almeida', 'Affiliation': 'Department of Psychiatry, Dell Medical School, University of Texas at Austin, Austin, TX, USA.'}, {'ForeName': 'Haris', 'Initials': 'H', 'LastName': 'Aslam', 'Affiliation': 'Department of Psychiatry, School of Medicine, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Thilo', 'Initials': 'T', 'LastName': 'Deckersbach', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Crystal', 'Initials': 'C', 'LastName': 'Cooper', 'Affiliation': 'Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Marisa S', 'Initials': 'MS', 'LastName': 'Toups', 'Affiliation': 'Department of Psychiatry, Dell Medical School, University of Texas at Austin, Austin, TX, USA.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Carmody', 'Affiliation': 'Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Benji', 'Initials': 'B', 'LastName': 'Kurian', 'Affiliation': 'Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Peltier', 'Affiliation': 'Functional MRI Laboratory, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Phillip', 'Initials': 'P', 'LastName': 'Adams', 'Affiliation': 'Department of Psychiatry, Columbia University College of Physicians and Surgeons and The New York State Psychiatric Institute, New York, NY, USA.'}, {'ForeName': 'Melvin G', 'Initials': 'MG', 'LastName': 'McInnis', 'Affiliation': 'Department of Psychiatry, School of Medicine, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Maria A', 'Initials': 'MA', 'LastName': 'Oquendo', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Fava', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Ramin', 'Initials': 'R', 'LastName': 'Parsey', 'Affiliation': 'Departments of Psychiatry and Behavioral Science & Radiology, Stony Brook University, Stony Brook, NY, USA.'}, {'ForeName': 'Patrick J', 'Initials': 'PJ', 'LastName': 'McGrath', 'Affiliation': 'Department of Psychiatry, Columbia University College of Physicians and Surgeons and The New York State Psychiatric Institute, New York, NY, USA.'}, {'ForeName': 'Myrna', 'Initials': 'M', 'LastName': 'Weissman', 'Affiliation': 'Department of Psychiatry, Columbia University College of Physicians and Surgeons and The New York State Psychiatric Institute, New York, NY, USA.'}, {'ForeName': 'Madhukar', 'Initials': 'M', 'LastName': 'Trivedi', 'Affiliation': 'Department of Psychiatry, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Mary L', 'Initials': 'ML', 'LastName': 'Phillips', 'Affiliation': 'Department of Psychiatry, School of Medicine, University of Pittsburgh, Pittsburgh, PA, USA.'}]",Molecular psychiatry,['10.1038/s41380-019-0490-5'] 1547,31473295,Minoxidil 1 mg oral versus minoxidil 5% topical solution for the treatment of female-pattern hair loss: A randomized clinical trial.,,2020,,['Female Pattern Hair Loss'],['Minoxidil'],[],"[{'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0449774', 'cui_str': 'Patterns (qualifier value)'}, {'cui': 'C0002170', 'cui_str': 'Hair Loss'}]","[{'cui': 'C0026196', 'cui_str': 'Minoxidil'}]",[],,0.0587897,,"[{'ForeName': 'Paulo Müller', 'Initials': 'PM', 'LastName': 'Ramos', 'Affiliation': 'Departamento de Dermatologia e Radioterapia, Universidade Estadual Paulista - UNESP, Botucatu, São Paulo, Brazil. Electronic address: dermato.paulo@gmail.com.'}, {'ForeName': 'Rodney D', 'Initials': 'RD', 'LastName': 'Sinclair', 'Affiliation': 'Department of Medicine, University of Melbourne, Parkville, Australia; Sinclair Dermatology, Melbourne, Australia.'}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Kasprzak', 'Affiliation': 'TrichoLAB, Bad Birmbach, Germany.'}, {'ForeName': 'Hélio Amante', 'Initials': 'HA', 'LastName': 'Miot', 'Affiliation': 'Departamento de Dermatologia e Radioterapia, Universidade Estadual Paulista - UNESP, Botucatu, São Paulo, Brazil.'}]",Journal of the American Academy of Dermatology,['10.1016/j.jaad.2019.08.060'] 1548,30649160,Does Self-Reported or Behavioral Impulsivity Predict Subjective Response to Low-Dose Alcohol?,"AIMS Subjective response to alcohol and impulsivity are both independent predictors of alcohol use and may be related risk factors for alcohol use disorders (AUDs). Recent findings suggest that more impulsive individuals may experience higher risk subjective response patterns at moderate-to-high doses of alcohol. However, whether these relationships are observable early in a drinking occasion remains an open question. This study examined multiple measures of impulsivity in relation to subjective response following low-dose alcohol. METHOD Eighty-seven non-treatment-seeking heavy drinkers were enrolled in a placebo-controlled alcohol administration study testing the effects of NMDA receptor antagonist, Memantine. Baseline impulsivity assessments included the Cued Go/No-Go Task, Experiential Discounting Task, and Barratt Impulsiveness Scale, Version 11 (BIS-11). Following consumption of low-dose alcohol aimed to increase blood alcohol concentration (BAC) to 0.03%, subjective stimulation and sedation were measured using the Biphasic Alcohol Effects Scale. Models were tested to relate impulsivity measures to subjective response with a post hoc exploratory model exploring boredom as an alternate predictor. RESULTS Increases in stimulation and sedation were observed following low-dose alcohol, but were not predicted significantly by impulsivity measures. Although greater impulsivity on the BIS-11 was a trend-level predictor of increased sedation, post hoc analyses suggested these results were an artifact of boredom. CONCLUSION Although impulsivity did not predict subjective response to low-dose alcohol, the results suggest that small amounts of alcohol can produce a range of subjective effects, even among heavy drinkers. Future studies would benefit by examining subjective response across a range of BACs among both light and heavy drinkers.",2019,"RESULTS Increases in stimulation and sedation were observed following low-dose alcohol, but were not predicted significantly by impulsivity measures.",['Eighty-seven non-treatment-seeking heavy drinkers'],"['placebo-controlled alcohol', 'NMDA receptor antagonist, Memantine']","['blood alcohol concentration (BAC', 'stimulation and sedation', 'impulsivity measures', 'Cued Go/No-Go Task, Experiential Discounting Task, and Barratt Impulsiveness Scale, Version 11 (BIS-11']","[{'cui': 'C4517895', 'cui_str': 'Eighty-seven'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0337678', 'cui_str': 'Heavy drinker (finding)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C0598695', 'cui_str': 'NMDA receptor antagonist'}, {'cui': 'C0025242', 'cui_str': 'Memantine'}]","[{'cui': 'C0684262', 'cui_str': 'Blood Alcohol Level'}, {'cui': 'C0887889', 'cui_str': 'BACs (Chromosomes)'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0021125', 'cui_str': 'Impulsivity'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0564567', 'cui_str': 'Impulsive character (finding)'}, {'cui': 'C0222045'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}, {'cui': 'C1872096', 'cui_str': 'bis(phenylacetylarginine)'}]",87.0,0.0115873,"RESULTS Increases in stimulation and sedation were observed following low-dose alcohol, but were not predicted significantly by impulsivity measures.","[{'ForeName': 'Benjamin L', 'Initials': 'BL', 'LastName': 'Berey', 'Affiliation': 'Department of Health Education and Behavior, University of Florida, 1908 Stadium Road, Gainesville, FL, USA.'}, {'ForeName': 'Robert F', 'Initials': 'RF', 'LastName': 'Leeman', 'Affiliation': 'Department of Health Education and Behavior, University of Florida, 1908 Stadium Road, Gainesville, FL, USA.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Pittman', 'Affiliation': 'Department of Psychiatry, School of Medicine, Yale University, 34 Park Street, New Haven, CT, USA.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Franco', 'Affiliation': 'Department of Psychiatry, School of Medicine, Yale University, 34 Park Street, New Haven, CT, USA.'}, {'ForeName': 'Suchitra', 'Initials': 'S', 'LastName': 'Krishnan-Sarin', 'Affiliation': 'Department of Psychiatry, School of Medicine, Yale University, 34 Park Street, New Haven, CT, USA.'}]","Alcohol and alcoholism (Oxford, Oxfordshire)",['10.1093/alcalc/agy092'] 1549,32439849,Effects of caffeine intake and exercise intensity on executive and arousal vigilance.,"During physical efforts and sport practice, vigilance is responsible for maintaining an optimal state of activation, guaranteeing the ability to quickly respond and detect unexpected, but critical, stimuli over time. Caffeine and physical exercise are able to modulate the activation state, affecting vigilance performance. The aim of the present work was to assess the specific effects and modulations of caffeine intake and two physical intensities on vigilance components. Participants performed an attentional task (ANTI-Vea) to measure the executive and arousal components of vigilance, in six double-blinded counterbalanced sessions combining caffeine, placebo, or no-ingestion, with light vs. moderate cyclergometer exercise. Exercise at moderate intensity improved executive vigilance with faster overall reaction time (RT), without impairing error rates. Instead, caffeine intake generally improved arousal vigilance. In conclusion, caffeine and acute exercise seems to moderate executive and arousal vigilance in different ways.",2020,"Exercise at moderate intensity improved executive vigilance with faster overall reaction time (RT), without impairing error rates.",[],"['Caffeine and physical exercise', 'caffeine', 'attentional task (ANTI-Vea', 'caffeine and acute exercise', 'caffeine intake and exercise intensity', 'caffeine, placebo, or no-ingestion, with light vs. moderate cyclergometer exercise']","['arousal vigilance', 'moderate executive and arousal vigilance', 'executive and arousal vigilance', 'executive vigilance with faster overall reaction time (RT), without impairing error rates']",[],"[{'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C4279937', 'cui_str': 'Acute Exercise'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}]","[{'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0043012', 'cui_str': 'Wakefulness'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}]",,0.0355207,"Exercise at moderate intensity improved executive vigilance with faster overall reaction time (RT), without impairing error rates.","[{'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Sanchis', 'Affiliation': 'Faculty of Physical Education & Sport Sciences, Catholic University of Valencia, Valencia, 46001, Spain. carlos.sanchis@ucv.es.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Blasco', 'Affiliation': 'Faculty of Physical Education & Sport Sciences, Catholic University of Valencia, Valencia, 46001, Spain.'}, {'ForeName': 'Fernando G', 'Initials': 'FG', 'LastName': 'Luna', 'Affiliation': 'Department of Experimental Psychology, Mind, Brain and Behavior Research Center, University of Granada, 18071, Granada, Spain.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Lupiáñez', 'Affiliation': 'Department of Experimental Psychology, Mind, Brain and Behavior Research Center, University of Granada, 18071, Granada, Spain. jlupiane@ugr.es.'}]",Scientific reports,['10.1038/s41598-020-65197-5'] 1550,31461123,Association of Multifaceted Mobile Technology-Enabled Primary Care Intervention With Cardiovascular Disease Risk Management in Rural Indonesia.,"Importance Cardiovascular diseases (CVDs) are the leading cause of disease burden in Indonesia. Implementation of effective interventions for CVD prevention is limited. Objective To evaluate whether a mobile technology-supported primary health care intervention, compared with usual care, would improve the use of preventive drug treatment among people in rural Indonesia with a high risk of CVD. Design, Setting, and Participants A quasi-experimental study involving 6579 high-risk individuals in 4 intervention and 4 control villages in Malang district, Indonesia, was conducted between August 16, 2016, and March 31, 2018. Median duration of follow-up was 12.2 months. Residents 40 years or older were invited to participate. Those with high estimated 10-year risk of CVD risk (previously diagnosed CVD, systolic blood pressure [BP] >160 mm Hg or diastolic BP >100 mm Hg, 10-year estimated CVD risk of 30% or more, or 10-year estimated CVD risk of 20%-29% and a systolic BP >140 mm Hg) were followed up. Interventions A multifaceted mobile technology-supported intervention facilitating community-based CVD risk screening with referral, tailored clinical decision support for drug prescription, and patient follow-up. Main Outcomes and Measures The primary outcome was the proportion of individuals taking appropriate preventive CVD medications, defined as at least 1 BP-lowering drug and a statin for all high-risk individuals, and an antiplatelet drug for those with prior diagnosed CVD. Secondary outcomes included mean change in BP from baseline. Results Among 22 635 adults, 3494 of 11 647 in the intervention villages (30.0%; 2166 women and 1328 men; mean [SD] age, 58.3 [10.9] years) and 3085 of 10 988 in the control villages (28.1%; 1838 women and 1247 men; mean [SD] age, 59.0 [11.5] years) had high estimated risk of CVD. Of these, follow-up was completed in 2632 individuals (75.3%) from intervention villages and 2429 individuals (78.7%) from control villages. At follow-up, 409 high-risk individuals in intervention villages (15.5%) were taking appropriate preventive CVD medications, compared with 25 (1.0%) in control villages (adjusted risk difference, 14.1%; 95% CI, 12.7%-15.6%). This difference was driven by higher use of BP-lowering medication in those in the intervention villages (1495 [56.8%] vs 382 [15.7%]; adjusted risk difference, 39.4%; 95% CI, 37.0%-41.7%). The adjusted mean difference in change in systolic BP from baseline was -8.3 mm Hg (95% CI, -10.1 to -6.6 mm Hg). Conclusions and Relevance This study found that a multifaceted mobile technology-supported primary health care intervention was associated with greater use of preventive CVD medication and lower BP levels among high-risk individuals in a rural Indonesian population.",2019,This study found that a multifaceted mobile technology-supported primary health care intervention was associated with greater use of preventive CVD medication and lower BP levels among high-risk individuals in a rural Indonesian population.,"['6579 high-risk individuals in 4 intervention and 4 control villages in Malang district, Indonesia, was conducted between August 16, 2016, and March 31, 2018', 'high-risk individuals in a rural Indonesian population', '2632 individuals (75.3%) from intervention villages and 2429 individuals (78.7%) from control villages', 'people in rural Indonesia with a high risk of CVD', 'Rural Indonesia', 'Among 22\u202f635 adults, 3494 of 11 647 in the intervention villages (30.0%; 2166 women and 1328 men; mean [SD] age, 58.3 [10.9] years) and 3085 of 10\u202f988 in the control villages (28.1%; 1838 women and 1247 men; mean [SD] age, 59.0 [11.5] years) had high estimated risk of CVD', 'Residents 40 years or older were invited to participate']","['Multifaceted Mobile Technology-Enabled Primary Care Intervention', 'multifaceted mobile technology-supported intervention facilitating community-based CVD risk screening with referral, tailored clinical decision support for drug prescription, and patient follow-up', 'mobile technology-supported primary health care intervention', 'multifaceted mobile technology-supported primary health care intervention']","['BP-lowering medication', 'Median duration', 'mean change in BP from baseline', 'BP levels', 'systolic BP', 'proportion of individuals taking appropriate preventive CVD medications, defined as at least 1 BP-lowering drug and a statin', 'systolic blood pressure [BP']","[{'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0562518', 'cui_str': 'Village environment (environment)'}, {'cui': 'C0021247', 'cui_str': 'East Indies'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0337900', 'cui_str': 'Indonesians (ethnic group)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0332167', 'cui_str': 'High risk of (contextual qualifier) (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4517534', 'cui_str': '11.5 (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C0205291', 'cui_str': 'Multifaceted (qualifier value)'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0562342', 'cui_str': 'Empowered (finding)'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0034927', 'cui_str': 'Referral'}, {'cui': 'C4042765', 'cui_str': 'Clinical Decision Support'}, {'cui': 'C0033081', 'cui_str': 'Drug Prescriptions'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]","[{'cui': 'C0020649', 'cui_str': 'Blood Pressure, Low'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C1456501', 'cui_str': 'Preventive'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0360714', 'cui_str': 'Statins'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}]",409.0,0.211716,This study found that a multifaceted mobile technology-supported primary health care intervention was associated with greater use of preventive CVD medication and lower BP levels among high-risk individuals in a rural Indonesian population.,"[{'ForeName': 'Anushka', 'Initials': 'A', 'LastName': 'Patel', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Devarsetty', 'Initials': 'D', 'LastName': 'Praveen', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Hyderabad, India.'}, {'ForeName': 'Asri', 'Initials': 'A', 'LastName': 'Maharani', 'Affiliation': 'Division of Neuroscience and Experimental Psychology, Faculty of Biology, Medicine and Health, The University of Manchester, Manchester, United Kingdom.'}, {'ForeName': 'Delvac', 'Initials': 'D', 'LastName': 'Oceandy', 'Affiliation': 'Division of Cardiovascular Sciences, The University of Manchester, Manchester Academic Health Science Centre, Manchester, United Kingdom.'}, {'ForeName': 'Quentin', 'Initials': 'Q', 'LastName': 'Pilard', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Mohan P S', 'Initials': 'MPS', 'LastName': 'Kohli', 'Affiliation': 'Independent Public Health Consultant, New Delhi, India.'}, {'ForeName': 'Sujarwoto', 'Initials': 'S', 'LastName': 'Sujarwoto', 'Affiliation': 'Department of Public Administration, University of Brawijaya, Malang, Indonesia.'}, {'ForeName': 'Gindo', 'Initials': 'G', 'LastName': 'Tampubolon', 'Affiliation': 'Global Development Institute, The University of Manchester, Manchester, United Kingdom.'}]",JAMA cardiology,['10.1001/jamacardio.2019.2974'] 1551,31268469,Effect of Aerobic and Resistance Exercise on Cardiac Adipose Tissues: Secondary Analyses From a Randomized Clinical Trial.,"Importance Epicardial and pericardial adipose tissues are emerging as important risk factors for cardiovascular disease, and there is a growing interest in discovering strategies to reduce the accumulation of fat in these depots. Objective To investigate whether a 12-week endurance or resistance training intervention regulates epicardial and pericardial adipose tissue mass. Design, Setting, and Participants Secondary analysis of a randomized, assessor-blinded clinical trial initiated on August 2016 and completed April 2018. This single-center, community-based study included 50 physically inactive participants with abdominal obesity. Interventions Participants were randomized to a supervised high-intensity interval endurance training (3 times a week for 45 minutes), resistance training (3 times a week for 45 minutes), or no exercise (control group). Main Outcomes and Measures Change in epicardial and pericardial adipose tissue mass assessed by magnetic resonance imaging, based on a prespecified secondary analysis plan including 3 of 5 parallel groups. Results Of 50 participants (mean [SD] age, 41 [14] years, 10 men [26%]; mean [SD] body mass index [calculated as weight in kilograms divided by height in meters squared], 32 [5]), 39 [78%] completed the study. Endurance training and resistance training reduced epicardial adipose tissue mass by 32% (95% CI, 10%-53%) and 24% (95% CI, 1%-46%), respectively, compared with the no exercise control group (56% [95% CI, 24%-88%]; P = .001 and 48% [95% CI, 15%-81%]; P < .001, respectively). While there was a nonsignificant reduction in pericardial adipose tissue mass after endurance training (11% [95% CI, -5% to 27%]; P = .17), resistance training significantly reduced pericardial adipose tissue mass by 31% (95% CI, 16%-47%; P < .001) when compared with the no exercise control group. Compared with the no exercise control group, there was an increase in left ventricular mass by endurance (20 g [95% CI, 11%-30%]; P < .001) and resistance training (18 g [95% CI, 8%-28%]; P < .001). Other cardiometabolic outcomes remained unchanged after the 12-week trial period. Conclusions and Relevance In individuals with abdominal obesity, both endurance and resistance training reduced epicardial adipose tissue mass, while only resistance training reduced pericardial adipose tissue mass. These data highlight the potential preventive importance of different exercise modalities as means to reduce cardiac fat in individuals with abdominal obesity. Trial Registration ClinicalTrials.gov identifier: NCT02901496.",2019,"Endurance training and resistance training reduced epicardial adipose tissue mass by 32% (95% CI, 10%-53%) and 24% (95% CI, 1%-46%), respectively, compared with the no exercise control group (56% [95% CI, 24%-88%]; P = .001 and 48% [95% CI, 15%-81%]; P < .001, respectively).","['individuals with abdominal obesity', 'Cardiac Adipose Tissues', '50 participants (mean [SD] age', '50 physically inactive participants with abdominal obesity', '41 [14] years, 10 men [26%]; mean [SD] body mass index [calculated as weight in kilograms divided by height in meters squared], 32 [5]), 39 [78%] completed the study']","['supervised high-intensity interval endurance training', 'endurance or resistance training intervention', 'Endurance training and resistance training', 'Aerobic and Resistance Exercise', 'resistance training (3\u2009times a week for\u200945 minutes), or no exercise (control group']","['epicardial and pericardial adipose tissue mass', 'pericardial adipose tissue mass', 'epicardial adipose tissue mass', 'left ventricular mass by endurance', 'resistance training']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0311277', 'cui_str': 'Central Obesity'}, {'cui': 'C0001527', 'cui_str': 'Fatty Tissue'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0444686', 'cui_str': 'Calculated (qualifier value)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0439209', 'cui_str': 'kg'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0475209', 'cui_str': 'm'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C4704697', 'cui_str': 'Endurance Training'}, {'cui': 'C0518031', 'cui_str': 'Endurance capacity'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C1442463', 'cui_str': 'Forty-five minutes (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0442016', 'cui_str': 'Epicardial (qualifier value)'}, {'cui': 'C0442031', 'cui_str': 'Pericardial (qualifier value)'}, {'cui': 'C0001527', 'cui_str': 'Fatty Tissue'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0455825', 'cui_str': 'Left ventricular mass (finding)'}, {'cui': 'C0518031', 'cui_str': 'Endurance capacity'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}]",50.0,0.183365,"Endurance training and resistance training reduced epicardial adipose tissue mass by 32% (95% CI, 10%-53%) and 24% (95% CI, 1%-46%), respectively, compared with the no exercise control group (56% [95% CI, 24%-88%]; P = .001 and 48% [95% CI, 15%-81%]; P < .001, respectively).","[{'ForeName': 'Regitse Højgaard', 'Initials': 'RH', 'LastName': 'Christensen', 'Affiliation': 'The Centre of Inflammation and Metabolism and the Centre for Physical Activity Research, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Anne-Sophie', 'Initials': 'AS', 'LastName': 'Wedell-Neergaard', 'Affiliation': 'The Centre of Inflammation and Metabolism and the Centre for Physical Activity Research, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Louise Lang', 'Initials': 'LL', 'LastName': 'Lehrskov', 'Affiliation': 'The Centre of Inflammation and Metabolism and the Centre for Physical Activity Research, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Grit Elster', 'Initials': 'GE', 'LastName': 'Legaard', 'Affiliation': 'The Centre of Inflammation and Metabolism and the Centre for Physical Activity Research, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Dorph', 'Affiliation': 'The Centre of Inflammation and Metabolism and the Centre for Physical Activity Research, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Monica Korsager', 'Initials': 'MK', 'LastName': 'Larsen', 'Affiliation': 'The Centre of Inflammation and Metabolism and the Centre for Physical Activity Research, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Natja', 'Initials': 'N', 'LastName': 'Launbo', 'Affiliation': 'The Centre of Inflammation and Metabolism and the Centre for Physical Activity Research, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Sabrina Ravn', 'Initials': 'SR', 'LastName': 'Fagerlind', 'Affiliation': 'The Centre of Inflammation and Metabolism and the Centre for Physical Activity Research, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Sidsel Kofoed', 'Initials': 'SK', 'LastName': 'Seide', 'Affiliation': 'The Centre of Inflammation and Metabolism and the Centre for Physical Activity Research, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Stine', 'Initials': 'S', 'LastName': 'Nymand', 'Affiliation': 'The Centre of Inflammation and Metabolism and the Centre for Physical Activity Research, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Ball', 'Affiliation': 'The Centre of Inflammation and Metabolism and the Centre for Physical Activity Research, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Nicole Buchner', 'Initials': 'NB', 'LastName': 'Vinum', 'Affiliation': 'The Centre of Inflammation and Metabolism and the Centre for Physical Activity Research, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Camilla Nørfelt', 'Initials': 'CN', 'LastName': 'Dahl', 'Affiliation': 'The Centre of Inflammation and Metabolism and the Centre for Physical Activity Research, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Henneberg', 'Affiliation': 'The Centre of Inflammation and Metabolism and the Centre for Physical Activity Research, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Mathias', 'Initials': 'M', 'LastName': 'Ried-Larsen', 'Affiliation': 'The Centre of Inflammation and Metabolism and the Centre for Physical Activity Research, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Mikael Ploug', 'Initials': 'MP', 'LastName': 'Boesen', 'Affiliation': 'Department of Radiology, Copenhagen University Hospital Bispebjerg, Copenhagen, Denmark.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Christensen', 'Affiliation': 'Musculoskeletal Statistics Unit, The Parker Institute, Bispebjerg and Frederiksberg Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Kristian', 'Initials': 'K', 'LastName': 'Karstoft', 'Affiliation': 'The Centre of Inflammation and Metabolism and the Centre for Physical Activity Research, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Rikke', 'Initials': 'R', 'LastName': 'Krogh-Madsen', 'Affiliation': 'The Centre of Inflammation and Metabolism and the Centre for Physical Activity Research, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Jaya Birgitte', 'Initials': 'JB', 'LastName': 'Rosenmeier', 'Affiliation': 'Department of Cardiology, Copenhagen University Hospital Bispebjerg, Capital Region of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Bente Klarlund', 'Initials': 'BK', 'LastName': 'Pedersen', 'Affiliation': 'The Centre of Inflammation and Metabolism and the Centre for Physical Activity Research, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Helga', 'Initials': 'H', 'LastName': 'Ellingsgaard', 'Affiliation': 'The Centre of Inflammation and Metabolism and the Centre for Physical Activity Research, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.'}]",JAMA cardiology,['10.1001/jamacardio.2019.2074'] 1552,31451013,Does Large Vessel Size Justify Use of Bare-Metal Stents in Primary Percutaneous Coronary Intervention?,"BACKGROUND Drug-eluting stents (DES) showed improved efficacy and safety compared with bare-metal stents (BMS), and international guidelines recommend their use as first line treatment. Yet, BMS are still widely used in practice, especially in large coronary vessels. We aimed to compare efficacy and safety of second-generation DES over BMS in large coronary culprit ST-segment elevated myocardial infarction lesions. METHODS We evaluated impact of large coronary stents (maximum size ≥3.50 mm) or smaller stents (<3.50 mm), among 1498 patients with ST-segment elevated myocardial infarction undergoing primary percutaneous coronary intervention, randomly allocated to everolimus-eluting DES or to an equivalent BMS platform in the EXAMINATION trial (Clinical Evaluation of the Xience-V Stent in Acute Myocardial Infarction Trial). Clinical events up to 5 years of follow-up were evaluated. RESULTS Large coronary stents were used in 683 patients (45.9%). At 5-year follow-up, the crude rate of the primary end point, a composite of all-cause death, any myocardial infarction, or any revascularization, was similar among patients treated with large or smaller coronary stents. The impact of DES versus BMS implantation was consistent irrespective of the stent size both for the primary end point (P int =0.82) and other secondary ischemic end points. Within patients treated with bigger stents, DES implantation was associated to a trend toward a reduction of target lesion (hazard ratio, 0.53; 95% CI, 0.27-1.02; P=0.05) and target vessel revascularization (hazard ratio, 0.60; 95% CI, 0.34-1.03; P=0.066). CONCLUSIONS Our results do not support the preferential use of BMS for patients with large coronary vessels. DES may warrant improved efficacy irrespective of stent size among patients undergoing primary percutaneous coronary intervention. CLINICAL TRIAL REGISTRATION URL: https://www.clinicaltrials.gov. Unique identifier: NCT00828087.",2019,The impact of DES versus BMS implantation was consistent irrespective of the stent size both for the primary end point (P int =0.82) and other secondary ischemic end points.,"['patients with large coronary vessels', '1498 patients with ST-segment elevated myocardial infarction undergoing primary percutaneous coronary intervention', 'patients undergoing primary percutaneous coronary intervention']","['bare-metal stents (BMS', 'everolimus-eluting DES or to an equivalent BMS platform', 'Drug-eluting stents (DES', 'Bare-Metal Stents', 'large coronary stents (maximum size ≥3.50 mm) or smaller stents', 'second-generation DES over BMS', 'DES']","['reduction of target lesion', 'composite of all-cause death, any myocardial infarction, or any revascularization', 'efficacy and safety', 'target vessel revascularization']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0010075', 'cui_str': 'Coronary Vessels'}, {'cui': 'C0520886', 'cui_str': 'ST segment elevation (finding)'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}]","[{'cui': 'C2825200', 'cui_str': 'Bare metal stent (physical object)'}, {'cui': 'C0541315', 'cui_str': 'everolimus'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0038257', 'cui_str': 'Stents'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0079411', 'cui_str': 'Generations'}]","[{'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0014742', 'cui_str': 'Erythema Multiforme'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0449618', 'cui_str': 'Target vessel (attribute)'}]",1498.0,0.186033,The impact of DES versus BMS implantation was consistent irrespective of the stent size both for the primary end point (P int =0.82) and other secondary ischemic end points.,"[{'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Costa', 'Affiliation': ""Instituto Clínico Cardiovascular (ICCV), Hospital Clínic i Provincial de Barcelona, Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Spain (F.C., S.A.P., E.F.-U., L.O.-P., M.S.).""}, {'ForeName': 'Salvatore', 'Initials': 'S', 'LastName': 'Brugaletta', 'Affiliation': ""Instituto Clínico Cardiovascular (ICCV), Hospital Clínic i Provincial de Barcelona, Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Spain (F.C., S.A.P., E.F.-U., L.O.-P., M.S.).""}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Pernigotti', 'Affiliation': ''}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Flores-Ulmanzor', 'Affiliation': ""Instituto Clínico Cardiovascular (ICCV), Hospital Clínic i Provincial de Barcelona, Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Spain (F.C., S.A.P., E.F.-U., L.O.-P., M.S.).""}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Ortega-Paz', 'Affiliation': ""Instituto Clínico Cardiovascular (ICCV), Hospital Clínic i Provincial de Barcelona, Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Spain (F.C., S.A.P., E.F.-U., L.O.-P., M.S.).""}, {'ForeName': 'Angel', 'Initials': 'A', 'LastName': 'Cequier', 'Affiliation': ''}, {'ForeName': 'Andres', 'Initials': 'A', 'LastName': 'Iniguez', 'Affiliation': 'Hospital Álvaro Cunqueiro - Vigo, Spain (A.I.).'}, {'ForeName': 'Antoni', 'Initials': 'A', 'LastName': 'Serra', 'Affiliation': ''}, {'ForeName': 'Pilar', 'Initials': 'P', 'LastName': 'Jiménez-Quevedo', 'Affiliation': 'University Hospital San Carlos, Madrid, Spain (P.J.-Q.).'}, {'ForeName': 'Vicente', 'Initials': 'V', 'LastName': 'Mainar', 'Affiliation': 'Hospital General of Alicante, Spain (V.M.).'}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Campo', 'Affiliation': 'Cardiovascular Institute, Azienda Ospedaliero-Universitaria di Ferrara, Cona (FE), Italy (G.C.).'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Tespili', 'Affiliation': 'University Hospital Bolognini Seriate, Bergamo, Italy (M.T.).'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'den Heijer', 'Affiliation': 'Amphia Ziekenhuis, Breda, the Netherlands (P.d.H.).'}, {'ForeName': 'Armando', 'Initials': 'A', 'LastName': 'Bethencourt', 'Affiliation': 'Hospital Son Espases, Palma de Mallorca, Spain (A.B.).'}, {'ForeName': 'Nicolás', 'Initials': 'N', 'LastName': 'Vazquez', 'Affiliation': 'Hospital Juan Canalejo, A Coruña, Spain (N.V.).'}, {'ForeName': 'Gerrit Anne', 'Initials': 'GA', 'LastName': 'van Es', 'Affiliation': 'Cardialysis, Rotterdam, the Netherlands (G.A.v.E., B.B.).'}, {'ForeName': 'Bianca', 'Initials': 'B', 'LastName': 'Backx', 'Affiliation': 'Cardialysis, Rotterdam, the Netherlands (G.A.v.E., B.B.).'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Valgimigli', 'Affiliation': 'University Hospital of Bern, Inselhospital, Switzerland (M.V.).'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Serruys', 'Affiliation': 'Imperial College London, United Kingdom (P.S.).'}, {'ForeName': 'Manel', 'Initials': 'M', 'LastName': 'Sabaté', 'Affiliation': ""Instituto Clínico Cardiovascular (ICCV), Hospital Clínic i Provincial de Barcelona, Institut d'Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS), Spain (F.C., S.A.P., E.F.-U., L.O.-P., M.S.).""}]",Circulation. Cardiovascular interventions,['10.1161/CIRCINTERVENTIONS.118.007705'] 1553,31451014,"Clinical Outcomes Following Implantation of Thin-Strut, Bioabsorbable Polymer-Coated, Everolimus-Eluting SYNERGY Stents.","BACKGROUND The thin-strut SYNERGY stent has an abluminal everolimus-eluting bioabsorbable polymer coating designed to facilitate vascular healing and reduce risk of stent thrombosis. In the multicenter, randomized EVOLVE II trial (The EVOLVE II Clinical Trial to Assess the SYNERGY Stent System for the Treatment of Atherosclerotic Lesion[s]), SYNERGY was noninferior to the durable polymer PROMUS Element Plus everolimus-eluting stent for the primary end point of 1-year target lesion failure. Longer-term clinical follow-up will support the relative efficacy and safety of SYNERGY. METHODS Patients with ≤3 native coronary lesions (reference vessel diameter ≥2.25-≤4.00 mm; length ≤34 mm) in ≤2 major epicardial vessels were randomized 1:1 to SYNERGY (N=838) or PROMUS Element Plus (N=846). EVOLVE II included a Diabetes substudy which pooled patients with diabetes mellitus from the randomized controlled trial (n=263) and from a sequential, single-arm substudy (N=203). RESULTS The 5-year target lesion failure rate was 14.3% for SYNERGY and 14.2% for PROMUS Element Plus (P=0.91). Landmark analysis demonstrated similar rates of target lesion failure from discharge to 1-year (P=0.90) and from 1 to 5 years (P=0.94). Definite/probable stent thrombosis was infrequent in both arms (SYNERGY 0.7% versus PROMUS Element Plus 0.9%; P=0.75). There were no significant differences in the rates of cardiac death, myocardial infarction, or revascularization. Among patients with diabetes mellitus, the target lesion failure rate to 1-year was noninferior to a prespecified performance goal and to 5 years was 17.0%. CONCLUSIONS SYNERGY demonstrated comparable outcomes to PROMUS Element Plus, with low rates of stent thrombosis and adverse events through 5 years of follow-up. Five-year clinical outcomes were favorable in patients with diabetes mellitus. These data support the long-term safety and effectiveness of SYNERGY in a broad range of patients. CLINICAL TRIAL REGISTRATION URL: https://www.clinicaltrials.gov. Unique identifier: NCT01665053.",2019,"CONCLUSIONS SYNERGY demonstrated comparable outcomes to PROMUS","['EVOLVE II included a Diabetes substudy which pooled patients with diabetes mellitus from the randomized controlled trial (n=263) and from a sequential, single-arm substudy (N=203', 'patients with diabetes mellitus', 'Patients with ≤3 native coronary lesions (reference vessel diameter ≥2.25-≤4.00 mm; length ≤34 mm) in ≤2 major epicardial vessels were randomized 1:1 to SYNERGY (N=838) or PROMUS']","['Implantation of Thin-Strut, Bioabsorbable Polymer-Coated, Everolimus-Eluting SYNERGY Stents']","['Definite/probable stent thrombosis', 'stent thrombosis and adverse events', 'rates of target lesion failure', 'rates of cardiac death, myocardial infarction, or revascularization', '5-year target lesion failure rate']","[{'cui': 'C0332253', 'cui_str': 'Evolving (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0337051', 'cui_str': 'Pool (environment)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0302891', 'cui_str': 'Native (qualifier value)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0148346', 'cui_str': 'Vessel'}, {'cui': 'C1301886', 'cui_str': 'Diameter (qualifier value)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0442016', 'cui_str': 'Epicardial (qualifier value)'}]","[{'cui': 'C0021107', 'cui_str': 'Insertion procedure'}, {'cui': 'C0332528', 'cui_str': 'Decreased thickness (finding)'}, {'cui': 'C0441295', 'cui_str': 'Strut (physical object)'}, {'cui': 'C0032521', 'cui_str': 'Polymers'}, {'cui': 'C0453946', 'cui_str': 'Coat (physical object)'}, {'cui': 'C0541315', 'cui_str': 'everolimus'}, {'cui': 'C0038257', 'cui_str': 'Stents'}]","[{'cui': 'C0439544', 'cui_str': 'Definite (qualifier value)'}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis (contextual qualifier) (qualifier value)'}, {'cui': 'C3897493', 'cui_str': 'Stent thrombosis'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0014742', 'cui_str': 'Erythema Multiforme'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0376297', 'cui_str': 'Cardiac Death'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]",,0.254462,"CONCLUSIONS SYNERGY demonstrated comparable outcomes to PROMUS","[{'ForeName': 'Dean J', 'Initials': 'DJ', 'LastName': 'Kereiakes', 'Affiliation': 'The Christ Hospital Heart and Vascular Center/The Lindner Research Center, Cincinnati, OH (D.J.K., I.J.S.).'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Windecker', 'Affiliation': 'Bern University Hospital, Inselspital, University of Bern, Switzerland (S.W.).'}, {'ForeName': 'R Lee', 'Initials': 'RL', 'LastName': 'Jobe', 'Affiliation': 'UNC-Rex Healthcare, Raleigh, NC (R.L.J.).'}, {'ForeName': 'Shamir R', 'Initials': 'SR', 'LastName': 'Mehta', 'Affiliation': 'McMaster University and Hamilton Health Sciences, Hamilton, ON, Canada (S.R.M.).'}, {'ForeName': 'Ian J', 'Initials': 'IJ', 'LastName': 'Sarembock', 'Affiliation': 'The Christ Hospital Heart and Vascular Center/The Lindner Research Center, Cincinnati, OH (D.J.K., I.J.S.).'}, {'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Feldman', 'Affiliation': 'MediQuest Research AdventHealth Ocala, FL (R.L.F.).'}, {'ForeName': 'Bernardo', 'Initials': 'B', 'LastName': 'Stein', 'Affiliation': 'Morton Plant Mease Healthcare System, Clearwater, FL (B.S.).'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Dubois', 'Affiliation': 'University Hospital Leuven, Belgium (C.D.).'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Grady', 'Affiliation': 'Aspirus Research Institute, Wausau, WI (T.G.).'}, {'ForeName': 'Shigeru', 'Initials': 'S', 'LastName': 'Saito', 'Affiliation': 'Shonan Kamakura General Hospital, Kanagawa, Japan (S.S.).'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Kimura', 'Affiliation': 'Kyoto University Hospital, Japan (T.K.).'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Underwood', 'Affiliation': 'Boston Scientific Corporation, Marlborough, MA (P.U., D.J.A., I.T.M.).'}, {'ForeName': 'Dominic J', 'Initials': 'DJ', 'LastName': 'Allocco', 'Affiliation': 'Boston Scientific Corporation, Marlborough, MA (P.U., D.J.A., I.T.M.).'}, {'ForeName': 'Ian T', 'Initials': 'IT', 'LastName': 'Meredith', 'Affiliation': 'Boston Scientific Corporation, Marlborough, MA (P.U., D.J.A., I.T.M.).'}]",Circulation. Cardiovascular interventions,['10.1161/CIRCINTERVENTIONS.119.008152'] 1554,31301621,Supported self-help to prevent relapse or recurrence of depression: Who benefits most?,"BACKGROUND This study aimed to identify subgroups for whom supported self-help preventive cognitive therapy (S-PCT) is more (cost)effective than treatment as usual (TAU) in preventing relapse and recurrence of major depression. METHODS We conducted a randomized controlled trial in which 248 remitted, recurrently depressed participants were randomized to S-PCT (n = 124) or TAU (n = 124). Clinical outcome was relapse or recurrence of major depressive disorder (SCID-I). We tested the moderating effects on relapse or recurrence of age, gender, education level, residual depressive symptoms, number of previous episodes, age of onset, antidepressant medication, somatization, and self-efficacy with logistic regression analyses adjusted for baseline values of depressive symptoms. We examined moderating effects on costs using linear regression analyses adjusted for baseline costs. A stratified cost-effectiveness analysis was performed to tease out differences in cost-effectiveness between subgroups. RESULTS We found no moderating effect on relapse or recurrence for any of the potential moderators. For costs, the number of previous depressive episodes was identified as a moderator. At a willingness-to-pay of 16,000€, the probability that S-PCT was cost-effective compared to TAU was 95% for participants with 2-3 episodes and 11% for participants with ≥4 episodes. LIMITATIONS Participants and counselors were not blinded. The study was primarily designed to assess the (cost)effectiveness of S-PCT and not to conduct moderation analyses. CONCLUSIONS S-PCT was effective in preventing relapse or recurrence of depressive disorders in a broad range of participants, but is more likely to be cost-effective in participants with 2-3 episodes than ≥4 episodes. This indicates that S-PCT can best be offered to participants with fewer previous depressive episodes.",2019,We found no moderating effect on relapse or recurrence for any of the potential moderators.,"['248 remitted, recurrently depressed participants', 'participants with fewer previous depressive episodes']","['supported self-help preventive cognitive therapy (S-PCT', 'S-PCT', 'TAU']","['relapse or recurrence of age, gender, education level, residual depressive symptoms, number of previous episodes, age of onset, antidepressant medication, somatization, and self-efficacy', 'relapse or recurrence of major depressive disorder (SCID-I', 'relapse or recurrence of depression', 'relapse or recurrence of depressive disorders', 'relapse or recurrence']","[{'cui': 'C0439600', 'cui_str': 'Remitting (qualifier value)'}, {'cui': 'C0205388', 'cui_str': 'Few (qualifier value)'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0349217', 'cui_str': 'Depressive episode'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1456501', 'cui_str': 'Preventive'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0162566', 'cui_str': 'Porphyria Cutanea Tarda'}, {'cui': 'C1720655', 'cui_str': 'Tau'}]","[{'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1609982', 'cui_str': 'Residual (qualifier value)'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant Drugs'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C0085110', 'cui_str': 'Severe Combined Immunologic Deficiency'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}]",248.0,0.175608,We found no moderating effect on relapse or recurrence for any of the potential moderators.,"[{'ForeName': 'Sandra Ma', 'Initials': 'SM', 'LastName': 'Dijkstra-Kersten', 'Affiliation': 'Amsterdam Public Health Research Institute, Department of General Practice and Elderly Care, Amsterdam UMC, Amsterdam, Netherlands. Electronic address: s.kersten@vumc.nl.'}, {'ForeName': 'Karolien Em', 'Initials': 'KE', 'LastName': 'Biesheuvel-Leliefeld', 'Affiliation': 'Amsterdam Public Health Research Institute, Department of General Practice and Elderly Care, Amsterdam UMC, Amsterdam, Netherlands.'}, {'ForeName': 'Johannes C', 'Initials': 'JC', 'LastName': 'van der Wouden', 'Affiliation': 'Amsterdam Public Health Research Institute, Department of General Practice and Elderly Care, Amsterdam UMC, Amsterdam, Netherlands.'}, {'ForeName': 'Digna Jf', 'Initials': 'DJ', 'LastName': 'van Schaik', 'Affiliation': 'Amsterdam Public Health Research Institute, Department of Psychiatry, Amsterdam UMC, Amsterdam, Netherlands.'}, {'ForeName': 'Judith E', 'Initials': 'JE', 'LastName': 'Bosmans', 'Affiliation': 'Amsterdam Public Health Research Institute, Department of Health Sciences, Vrije Universiteit, Amsterdam, Netherlands.'}, {'ForeName': 'Harm Wj', 'Initials': 'HW', 'LastName': 'van Marwijk', 'Affiliation': 'Department of Primary Care and Public Health Medicine, Brighton and Sussex Medical School, Brighton, United Kingdom.'}, {'ForeName': 'Henriette E', 'Initials': 'HE', 'LastName': 'van der Horst', 'Affiliation': 'Amsterdam Public Health Research Institute, Department of General Practice and Elderly Care, Amsterdam UMC, Amsterdam, Netherlands.'}]",Journal of affective disorders,['10.1016/j.jad.2019.07.006'] 1555,31447130,Long-term Safety and Clinical Benefit of Mepolizumab in Patients With the Most Severe Eosinophilic Asthma: The COSMEX Study.,"PURPOSE The goal of this study was to assess the long-term safety and efficacy of mepolizumab in patients with the most severe eosinophilic asthma. METHODS This multicenter, open-label, long-term, Phase IIIb study (COSMEX [COSMOS Extension]; 201312/NCT02135692) enrolled patients from the 52-week, open-label extension study COSMOS (A Study to Determine Long-term Safety of Mepolizumab in Asthmatic Subjects) that previously enrolled patients from the double-blinded, placebo-controlled Phase III studies MENSA (Mepolizumab as Adjunctive Therapy in Patients with Severe Asthma) and SIRIUS (Steroid Reduction with Mepolizumab Study). To enter COSMEX, patients had to have life-threatening/seriously debilitating asthma before entering MENSA or SIRIUS and to have completed these previous studies with demonstrated improvement while receiving mepolizumab. In COSMEX, patients received mepolizumab 100 mg subcutaneously every 4 weeks as add-on therapy for up to 172 weeks. Primary endpoints were adverse event frequency and exacerbation rate per year; also assessed were forced expiratory volume in 1 s, Asthma Control Questionnaire-5 score, and daily oral corticosteroid (OCS) use. FINDINGS Of the 340 patients enrolled, 339 received mepolizumab; median treatment duration within this extension study was 2.2 years, equating to 718 patient-years of additional exposure. No new safety signals were identified. Patients receiving mepolizumab throughout this study and previous studies had lasting reductions in exacerbation rate and daily OCS use and improvements in forced expiratory volume in 1 s and Asthma Control Questionnaire-5 score. In COSMEX, the on-treatment exacerbation rate (95% CI) was 0.93 (0.81-1.06) event/year for clinically significant exacerbations, 0.13 (0.10-0.18) event/year for exacerbations requiring hospitalization/emergency department visit, and 0.07 (0.05-0.10) event/year for exacerbations requiring hospitalization. In patients requiring systemic/oral corticosteroids with ≥128 weeks of continuous enrollment across SIRIUS, COSMOS, and COSMEX, mepolizumab maintained the median daily OCS dose at 1.3-2.8 mg during COSMEX, with additional patients no longer requiring OCS after extended mepolizumab treatment. IMPLICATIONS This study indicates that long-term mepolizumab treatment is well tolerated and associated with sustained clinical benefits in patients with severe eosinophilic asthma. ClinicalTrials.gov identifier: NCT02135692.",2019,Patients receiving mepolizumab throughout this study and previous studies had lasting reductions in exacerbation rate and daily OCS use and improvements in forced expiratory volume in 1 s and Asthma Control Questionnaire-5 score.,"['patients with the most severe eosinophilic asthma', 'Patients', 'patients with severe eosinophilic asthma', 'in Patients with Severe Asthma) and SIRIUS (Steroid Reduction with Mepolizumab Study', '340 patients enrolled']","['Mepolizumab', 'mepolizumab', 'placebo-controlled Phase III studies MENSA (Mepolizumab as Adjunctive Therapy']","['adverse event frequency and exacerbation rate per year; also assessed were forced expiratory volume in 1\xa0s, Asthma Control Questionnaire-5 score, and daily oral corticosteroid (OCS) use', 'exacerbation rate and daily OCS use and improvements in forced expiratory volume in 1\xa0s and Asthma Control Questionnaire-5 score', 'treatment exacerbation rate']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0034068', 'cui_str': 'Pulmonary Eosinophilia'}, {'cui': 'C0581126', 'cui_str': 'Severe asthma'}, {'cui': 'C0038317', 'cui_str': 'Steroids'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0969324', 'cui_str': 'mepolizumab'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C4517730', 'cui_str': '340'}]","[{'cui': 'C0969324', 'cui_str': 'mepolizumab'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0439508', 'cui_str': 'per year'}, {'cui': 'C1306036', 'cui_str': 'Forced expiratory volume'}, {'cui': 'C2919686', 'cui_str': 'Asthma control questionnaire'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]",340.0,0.180543,Patients receiving mepolizumab throughout this study and previous studies had lasting reductions in exacerbation rate and daily OCS use and improvements in forced expiratory volume in 1 s and Asthma Control Questionnaire-5 score.,"[{'ForeName': 'Sandhya', 'Initials': 'S', 'LastName': 'Khurana', 'Affiliation': 'Department of Medicine/Pulmonary, University of Rochester School of Medicine & Dentistry, Rochester, NY, USA.'}, {'ForeName': 'Guy G', 'Initials': 'GG', 'LastName': 'Brusselle', 'Affiliation': 'Department of Respiratory Medicine, Ghent University Hospital, Ghent, Belgium.'}, {'ForeName': 'Elisabeth H', 'Initials': 'EH', 'LastName': 'Bel', 'Affiliation': 'Department of Respiratory Medicine, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'J Mark', 'Initials': 'JM', 'LastName': 'FitzGerald', 'Affiliation': 'Department of Medicine, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Masoli', 'Affiliation': 'Department of Respiratory Medicine, University Hospitals Plymouth NHS Trust, Plymouth, United Kingdom.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Korn', 'Affiliation': 'Pulmonary Department, Universitätsmedizin Mainz, Mainz, Germany.'}, {'ForeName': 'Motokazu', 'Initials': 'M', 'LastName': 'Kato', 'Affiliation': 'Chest Disease Clinical and Research Institute, Kishiwada City Hospital, Osaka, Japan.'}, {'ForeName': 'Frank C', 'Initials': 'FC', 'LastName': 'Albers', 'Affiliation': 'Respiratory Medical Franchise, GlaxoSmithKline, Research Triangle Park, NC, USA. Electronic address: frank-c.albers@t-online.de.'}, {'ForeName': 'Eric S', 'Initials': 'ES', 'LastName': 'Bradford', 'Affiliation': 'Respiratory Therapeutic Area, GlaxoSmithKline, Research Triangle Park, NC, USA.'}, {'ForeName': 'Martyn J', 'Initials': 'MJ', 'LastName': 'Gilson', 'Affiliation': 'Respiratory Research and Development, GlaxoSmithKline, Stockley Park, Uxbridge, Middlesex, United Kingdom.'}, {'ForeName': 'Robert G', 'Initials': 'RG', 'LastName': 'Price', 'Affiliation': 'Clinical Statistics, GlaxoSmithKline, Stevenage, Hertfordshire, United Kingdom.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Humbert', 'Affiliation': 'Assistance Publique -Hôpitaux de Paris, Service de Pneumologie, Hôpital Bicêtre, Paris, France; Univ. Paris-Sud, Université Paris-Saclay, Paris, France; INSERM U999, Le Kremlin-Bicêtre, Paris, France.'}]",Clinical therapeutics,['10.1016/j.clinthera.2019.07.007'] 1556,31434028,"Effects of non-tobacco flavors and nicotine on e-cigarette product appeal among young adult never, former, and current smokers.","BACKGROUND E-cigarette regulations targeting products that disproportionately appeal to never-smokers may optimize population health. This laboratory study of young adults tested whether differences in appeal between e-cigarettes with non-tobacco-flavored (vs. tobacco-flavored) and nicotine-containing (vs. nicotine-free) solutions varied by smoking history. METHODS Current (N = 53), former (N = 25), and never (N = 22) cigarette smokers who vape (Mean[SD] age = 25.4[4.4] years) administered standardized e-cigarette doses varied by a Flavor (fruit, menthol, tobacco) × Nicotine (nicotine-containing [6 mg/mL], nicotine-free) within-subject double-blind design. Participants rated each dose's appeal (0-100 scale). Covariate-adjusted interactions tested whether smoking history moderated flavor and nicotine effects. RESULTS Appeal was higher for fruit and menthol than tobacco flavors in each group. The fruit vs. tobacco appeal difference was greater in never smokers (fruit-tobacco estimate = 19.6) than current smokers (estimate = 12.1) but not former smokers (estimate = 12.6). The menthol vs. tobacco difference was greater in never smokers (menthol-tobacco estimate = 17.3) than former (estimate = 6.0) and current (estimate = 7.2) smokers. Appeal was lower for nicotine-containing than nicotine-free solutions in each group; this difference was greater in never smokers (nicotine-nicotine-free estimate = -17.3) than former (estimate = -7.0) and current (estimate = -10.6) smokers. Compared to tobacco flavors, nicotine's appeal-reducing effects were suppressed by fruit and menthol flavors in never smokers. CONCLUSIONS Higher appeal of non-tobacco-flavored (vs. tobacco-flavored) and lower appeal of nicotine-containing (vs. nicotine-free) e-cigarettes may be widespread in young adults but disproportionately amplified in never smokers. Non-tobacco flavors may suppress nicotine's appeal-lowering qualities in never smokers. The impact of regulating non-tobacco flavors in e-cigarettes may vary by smoking history.",2019,Appeal was lower for nicotine-containing than nicotine-free solutions in each group; this difference was greater in never smokers (nicotine-nicotine-free estimate = -17.3) than former (estimate = -7.0) and current (estimate = -10.6) smokers.,"['young adults tested whether differences in appeal between e-cigarettes with non-tobacco-flavored (vs. tobacco-flavored) and', 'young adults', 'young adult never, former, and current smokers', 'Current (N\u202f=\u202f53), former (N\u202f=\u202f25), and never (N\u202f=\u202f22) cigarette smokers who vape (Mean[SD] age\u202f=\u202f25.4[4.4] years) administered']","['standardized e-cigarette doses varied by a Flavor (fruit, menthol, tobacco) × Nicotine (nicotine-containing [6\u202fmg/mL], nicotine-free', 'non-tobacco flavors and nicotine', 'nicotine-containing (vs. nicotine-free) e-cigarettes', 'nicotine-containing (vs. nicotine-free) solutions']",[],"[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C3849993', 'cui_str': 'Electronic Cigarettes'}, {'cui': 'C0040329', 'cui_str': 'Tobacco Products'}, {'cui': 'C3241966'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0337667', 'cui_str': 'Cigarette smoker (finding)'}, {'cui': 'C4083280', 'cui_str': 'Vaping'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1621583', 'cui_str': 'Administer'}]","[{'cui': 'C3849993', 'cui_str': 'Electronic Cigarettes'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0025368', 'cui_str': 'Menthol'}, {'cui': 'C0040329', 'cui_str': 'Tobacco Products'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0439294', 'cui_str': 'mcg/mcL'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}]",[],,0.0349391,Appeal was lower for nicotine-containing than nicotine-free solutions in each group; this difference was greater in never smokers (nicotine-nicotine-free estimate = -17.3) than former (estimate = -7.0) and current (estimate = -10.6) smokers.,"[{'ForeName': 'Adam M', 'Initials': 'AM', 'LastName': 'Leventhal', 'Affiliation': 'Department of Preventive Medicine, University of Southern California Keck School of Medicine, Los Angeles, CA, USA; Department of Psychology, University of Southern California, Los Angeles, CA, USA. Electronic address: adam.leventhal@usc.edu.'}, {'ForeName': 'Nicholas I', 'Initials': 'NI', 'LastName': 'Goldenson', 'Affiliation': 'Department of Preventive Medicine, University of Southern California Keck School of Medicine, Los Angeles, CA, USA.'}, {'ForeName': 'Jessica L', 'Initials': 'JL', 'LastName': 'Barrington-Trimis', 'Affiliation': 'Department of Preventive Medicine, University of Southern California Keck School of Medicine, Los Angeles, CA, USA.'}, {'ForeName': 'Raina D', 'Initials': 'RD', 'LastName': 'Pang', 'Affiliation': 'Department of Preventive Medicine, University of Southern California Keck School of Medicine, Los Angeles, CA, USA.'}, {'ForeName': 'Matthew G', 'Initials': 'MG', 'LastName': 'Kirkpatrick', 'Affiliation': 'Department of Preventive Medicine, University of Southern California Keck School of Medicine, Los Angeles, CA, USA.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2019.05.020'] 1557,32496624,Clinical and radiographic assessment of circular versus triangular cross-section neck Implants in the posterior maxilla: A 1-year randomized controlled trial.,"OBJECTIVES Implants with a triangular neck were recently introduced to limit peri-implant bone loss. The primary objective of this randomized controlled trial was to compare peri-implant bone changes of circular versus triangular cross-section neck implants 1 year after loading. The secondary objectives were to assess buccal hard tissue thickness changes, Pink Esthetic Score (PES), and patient satisfaction. MATERIAL AND METHODS Thirty four patients requiring replacement of the single, intercalated missing tooth of healed site for at least 4 months in the posterior maxilla were randomized into 2 groups according to the type of implant. Immediately after surgery and 1 year after final restoration, a cone beam CT (CBCT) was performed to assess proximal bone remodeling and buccal bone thickness. Peri-implant soft tissue health, PES, and patient-reported outcome measures (PROMs) were recorded. RESULTS No implant loss occurred within the follow-up period. The mean ± SD peri-implant proximal bone loss 1 year after loading was 0.22 ± 0.30 mm for triangular and 0.42 ± 0.67 mm for circular implants necks (p = .25). Peri-implant bone loss exceeding 2 mm was observed in a single implant in the circular neck group. Buccal bone thickness remained stable and did not differ different between the 2 groups. The peri-implant soft tissue health, PES, and patient satisfaction were also comparable. CONCLUSIONS Within the limitations of the present study, patient clinical and radiographic outcomes did not differ between triangular and circular cross-section neck implants in the posterior maxilla.",2020,Buccal bone thickness remained stable and did not differ different between the 2 groups.,"['Thirty four patients requiring replacement of the single, intercalated missing tooth of healed site for at least 4 months in the posterior maxilla', 'Posterior Maxilla']","['Circular Versus Triangular cross-section neck Implants', 'circular versus triangular cross-section neck implants 1-year after loading', 'cone beam CT (CBCT']","['implant loss', 'Buccal bone thickness', 'mean ± SD peri-implant proximal bone loss 1-year', 'buccal hard tissue thickness changes, Pink Esthetic Score (PES) and patient satisfaction', 'proximal bone remodeling and buccal bone thickness', 'Peri-implant bone loss']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0080233', 'cui_str': 'Tooth loss'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0024947', 'cui_str': 'Bone structure of maxilla'}]","[{'cui': 'C1282913', 'cui_str': 'Circular'}, {'cui': 'C0205119', 'cui_str': 'Triangular'}, {'cui': 'C0205203', 'cui_str': 'Crossed'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1956110', 'cui_str': 'Cone beam CT'}]","[{'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0442010', 'cui_str': 'Buccal'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0029453', 'cui_str': 'Osteopenia'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0018599', 'cui_str': 'Hard'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0332585', 'cui_str': 'Pink color'}, {'cui': 'C0014901', 'cui_str': 'Aesthetics'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0085268', 'cui_str': 'Bone remodeling'}]",34.0,0.145292,Buccal bone thickness remained stable and did not differ different between the 2 groups.,"[{'ForeName': 'Lou', 'Initials': 'L', 'LastName': 'Li Manni', 'Affiliation': 'Department of Periodontology and Oral Surgery, University Hospital of Liège, Liège, Belgium.'}, {'ForeName': 'Geoffrey', 'Initials': 'G', 'LastName': 'Lecloux', 'Affiliation': 'Department of Periodontology and Oral Surgery, University Hospital of Liège, Liège, Belgium.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Rompen', 'Affiliation': 'Department of Periodontology and Oral Surgery, University Hospital of Liège, Liège, Belgium.'}, {'ForeName': 'Walid', 'Initials': 'W', 'LastName': 'Aouini', 'Affiliation': 'Department of Periodontology and Oral Surgery, University Hospital of Liège, Liège, Belgium.'}, {'ForeName': 'Lior', 'Initials': 'L', 'LastName': 'Shapira', 'Affiliation': 'Department of Periodontology, Hebrew University-Hadassah Faculty of Dental Medicine, Jerusalem, Israel.'}, {'ForeName': 'France', 'Initials': 'F', 'LastName': 'Lambert', 'Affiliation': 'Department of Periodontology and Oral Surgery, University Hospital of Liège, Liège, Belgium.'}]",Clinical oral implants research,['10.1111/clr.13624'] 1558,31434508,Effect of Empagliflozin on Left Ventricular Mass in Patients With Type 2 Diabetes Mellitus and Coronary Artery Disease: The EMPA-HEART CardioLink-6 Randomized Clinical Trial.,"BACKGROUND SGLT2 (sodium-glucose cotransporter 2) inhibitors lower cardiovascular events in type 2 diabetes mellitus but whether they promote direct cardiac effects remains unknown. We sought to determine if empagliflozin causes a decrease in left ventricular (LV) mass in people with type 2 diabetes mellitus and coronary artery disease. METHODS Between November 2016 and April 2018, we recruited 97 individuals ≥40 and ≤80 years old with glycated hemoglobin 6.5% to 10.0%, known coronary artery disease, and estimated glomerular filtration rate ≥60mL/min/1.73m 2 . The participants were randomized to empagliflozin (10 mg/day, n=49) or placebo (n=48) for 6 months, in addition to standard of care. The primary outcome was the 6-month change in LV mass indexed to body surface area from baseline as measured by cardiac magnetic resonance imaging. Other measures included 6-month changes in LV end-diastolic and -systolic volumes indexed to body surface area, ejection fraction, 24-hour ambulatory blood pressure, hematocrit, and NT-proBNP (N-terminal pro b-type natriuretic peptide). RESULTS Among the 97 participants (90 men [93%], mean [standard deviation] age 62.8 [9.0] years, type 2 diabetes mellitus duration 11.0 [8.2] years, estimated glomerular filtration rate 88.4 [16.9] mL/min/1.73m 2 , LV mass indexed to body surface area 60.7 [11.9] g/m 2 ), 90 had evaluable imaging at follow-up. Mean LV mass indexed to body surface area regression over 6 months was 2.6 g/m 2 and 0.01 g/m 2 for those assigned empagliflozin and placebo, respectively (adjusted difference -3.35 g/m 2 ; 95% CI, -5.9 to -0.81g/m 2 , P =0.01). In the empagliflozin-allocated group, there was significant lowering of overall ambulatory systolic blood pressure (adjusted difference -6.8mmHg, 95% CI -11.2 to -2.3mmHg, P =0.003), diastolic blood pressure (adjusted difference -3.2mmHg; 95% CI, -5.8 to -0.6mmHg, P =0.02) and elevation of hematocrit ( P =0.0003). CONCLUSIONS Among people with type 2 diabetes mellitus and coronary artery disease, SGLT2 inhibition with empagliflozin was associated with significant reduction in LV mass indexed to body surface area after 6 months, which may account in part for the beneficial cardiovascular outcomes observed in the EMPA-REG OUTCOME (BI 10773 [Empagliflozin] Cardiovascular Outcome Event Trial in Type 2 Diabetes Mellitus Patients) trial. CLINICAL TRIAL REGISTRATION URL: https://www.clinicaltrials.gov. Unique identifier: NCT02998970.",2019,"Mean LVMi regression over 6 months was 2.6 g/m 2 and 0.01 g/m 2 for those assigned empagliflozin and placebo, respectively (adjusted difference -3.35","['97 participants (90 men [93%], mean [SD] age 62.8 [9.0] years, T2DM duration 11.0 [8.2] years, eGFR 88.4', 'people with T2DM and coronary artery disease (CAD', '97 individuals ≥40 and ≤80 years old with glycated hemoglobin 6.5 to 10.0%, known CAD and estimated glomerular filtration rate (eGFR) ≥60mL/min/1.73m 2 ', 'Patients with Type 2 Diabetes and Coronary Artery Disease', 'type 2 diabetes (T2DM', 'Between November 2016 and April 2018']","['empagliflozin', 'Sodium-glucose co-transporter 2', 'placebo', 'Empagliflozin']","['left ventricular (LV) mass', 'LVMi', 'diastolic blood pressure', 'elevation of hematocrit', '6-month change in LV mass indexed (LVMi) to body surface area (BSA', 'overall ambulatory systolic blood pressure', '6-month changes in LV end-diastolic and -systolic volumes indexed to BSA (LVEDVi and LVESVi), ejection fraction (LVEF), 24-h ambulatory blood pressure, hematocrit and N-terminal pro b-type natriuretic peptide (NT-proBNP', 'Mean LVMi regression', 'Left Ventricular Mass']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C3844007', 'cui_str': '6.5'}, {'cui': 'C0205309', 'cui_str': 'Known (qualifier value)'}, {'cui': 'C3811844'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}]","[{'cui': 'C3490348', 'cui_str': 'empagliflozin'}, {'cui': 'C3541959', 'cui_str': 'Sodium supplement (substance)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0598849', 'cui_str': 'Co-Transporters'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0455825', 'cui_str': 'Left ventricular mass (finding)'}, {'cui': 'C1305849', 'cui_str': 'Blood pressure diastolic'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0518014', 'cui_str': 'Hematocrit - finding'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0005902', 'cui_str': 'Body Surface Area'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0439841', 'cui_str': 'Ambulatory'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0754710', 'cui_str': 'Amino-terminal pro-brain natriuretic peptide'}, {'cui': 'C1963813', 'cui_str': 'NT-proBNP'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0684321', 'cui_str': 'Regression'}]",97.0,0.492749,"Mean LVMi regression over 6 months was 2.6 g/m 2 and 0.01 g/m 2 for those assigned empagliflozin and placebo, respectively (adjusted difference -3.35","[{'ForeName': 'Subodh', 'Initials': 'S', 'LastName': 'Verma', 'Affiliation': ""Division of Cardiac Surgery (S.V., T.M, V.G., H.T., A.Q.), Li Ka Shing Knowledge Institute of St. Michael's Hospital, Toronto, Ontario, Canada.""}, {'ForeName': 'C David', 'Initials': 'CD', 'LastName': 'Mazer', 'Affiliation': ""Department of Anesthesia (C.D.M.), Li Ka Shing Knowledge Institute of St. Michael's Hospital, Toronto, Ontario, Canada.""}, {'ForeName': 'Andrew T', 'Initials': 'AT', 'LastName': 'Yan', 'Affiliation': ""Division of Cardiology (A.T.Y., D.H.F., S.G.G., K.A.C.), Li Ka Shing Knowledge Institute of St. Michael's Hospital, Toronto, Ontario, Canada.""}, {'ForeName': 'Tamique', 'Initials': 'T', 'LastName': 'Mason', 'Affiliation': ""Division of Cardiac Surgery (S.V., T.M, V.G., H.T., A.Q.), Li Ka Shing Knowledge Institute of St. Michael's Hospital, Toronto, Ontario, Canada.""}, {'ForeName': 'Vinay', 'Initials': 'V', 'LastName': 'Garg', 'Affiliation': ""Division of Cardiac Surgery (S.V., T.M, V.G., H.T., A.Q.), Li Ka Shing Knowledge Institute of St. Michael's Hospital, Toronto, Ontario, Canada.""}, {'ForeName': 'Hwee', 'Initials': 'H', 'LastName': 'Teoh', 'Affiliation': ""Division of Cardiac Surgery (S.V., T.M, V.G., H.T., A.Q.), Li Ka Shing Knowledge Institute of St. Michael's Hospital, Toronto, Ontario, Canada.""}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Zuo', 'Affiliation': ""Applied Health Research Centre (F.Z., P.J.), Li Ka Shing Knowledge Institute of St. Michael's Hospital, Toronto, Ontario, Canada.""}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Quan', 'Affiliation': ""Division of Cardiac Surgery (S.V., T.M, V.G., H.T., A.Q.), Li Ka Shing Knowledge Institute of St. Michael's Hospital, Toronto, Ontario, Canada.""}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Farkouh', 'Affiliation': 'Department of Medicine (A.T.Y., V.G., M.E.F., D.H.F., S.G.G., R.E.G., L.A.L., P.J., B.Z., K.A.C.), University of Toronto, Ontario, Canada.'}, {'ForeName': 'David H', 'Initials': 'DH', 'LastName': 'Fitchett', 'Affiliation': ""Division of Cardiology (A.T.Y., D.H.F., S.G.G., K.A.C.), Li Ka Shing Knowledge Institute of St. Michael's Hospital, Toronto, Ontario, Canada.""}, {'ForeName': 'Shaun G', 'Initials': 'SG', 'LastName': 'Goodman', 'Affiliation': ""Division of Cardiology (A.T.Y., D.H.F., S.G.G., K.A.C.), Li Ka Shing Knowledge Institute of St. Michael's Hospital, Toronto, Ontario, Canada.""}, {'ForeName': 'Ronald M', 'Initials': 'RM', 'LastName': 'Goldenberg', 'Affiliation': 'LMC Diabetes & Endocrinology, Concord, Ontario, Canada (R.M.G.).'}, {'ForeName': 'Mohammed', 'Initials': 'M', 'LastName': 'Al-Omran', 'Affiliation': ""Division of Vascular Surgery (M.A.O.), Li Ka Shing Knowledge Institute of St. Michael's Hospital, Toronto, Ontario, Canada.""}, {'ForeName': 'Richard E', 'Initials': 'RE', 'LastName': 'Gilbert', 'Affiliation': ""Division of Endocrinology and Metabolism (H.T., R.E.G., L.A.L.), Li Ka Shing Knowledge Institute of St. Michael's Hospital, Toronto, Ontario, Canada.""}, {'ForeName': 'Deepak L', 'Initials': 'DL', 'LastName': 'Bhatt', 'Affiliation': ""Brigham and Women's Hospital Heart & Vascular Center, Harvard Medical School, Boston, MA (D.L.B.).""}, {'ForeName': 'Lawrence A', 'Initials': 'LA', 'LastName': 'Leiter', 'Affiliation': ""Division of Endocrinology and Metabolism (H.T., R.E.G., L.A.L.), Li Ka Shing Knowledge Institute of St. Michael's Hospital, Toronto, Ontario, Canada.""}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Jüni', 'Affiliation': ""Applied Health Research Centre (F.Z., P.J.), Li Ka Shing Knowledge Institute of St. Michael's Hospital, Toronto, Ontario, Canada.""}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Zinman', 'Affiliation': 'Department of Medicine (A.T.Y., V.G., M.E.F., D.H.F., S.G.G., R.E.G., L.A.L., P.J., B.Z., K.A.C.), University of Toronto, Ontario, Canada.'}, {'ForeName': 'Kim A', 'Initials': 'KA', 'LastName': 'Connelly', 'Affiliation': ""Division of Cardiology (A.T.Y., D.H.F., S.G.G., K.A.C.), Li Ka Shing Knowledge Institute of St. Michael's Hospital, Toronto, Ontario, Canada.""}]",Circulation,['10.1161/CIRCULATIONAHA.119.042375'] 1559,32012080,Effect of 5-Minute Movies Shown via a Mobile Phone App on Risk Factors and Mortality After Stroke in a Low- to Middle-Income Country: Randomized Controlled Trial for the Stroke Caregiver Dyad Education Intervention (Movies4Stroke).,"BACKGROUND Pakistan is the sixth most populous nation in the world and has an estimated 4 million stroke survivors. Most survivors are taken care of by community-based caregivers, and there are no inpatient rehabilitation facilities. OBJECTIVE The objective of this study was to evaluate the effectiveness and safety of locally designed 5-min movies rolled out in order of relevance that are thematically delivered in a 3-month program to deliver poststroke education to stroke survivor and caregiver dyads returning to the community. METHODS This study was a randomized controlled, outcome assessor-blinded, parallel group, single-center superiority trial in which participants (stroke survivor-caregiver dyads) with first-ever stroke (both ischemic and hemorrhagic) incidence were randomized within 48 hours of their stroke into either the video-based education intervention group or the control group. The video-based education intervention group had health education delivered through short videos that were shown to the participants and their caregivers at the time of admission, before discharge, and the first and third months of follow-up after discharge. The control group had standardized care including predischarge education and counseling according to defined protocols. All participants enrolled in the video education intervention and control groups were followed for 12 months after discharge for outcome assessment in the outpatient stroke clinics. The primary outcome measures were the proportion of participants achieving control of blood pressure, blood sugar, and blood cholesterol in the video intervention versus the control group. Several predefined secondary outcomes were included in this study, of which we report the mortality and functional disability in this paper. Analysis was by performed using the intention-to-treat principle. RESULTS A total of 310 stroke survivors and their caregiver dyads (participant dyads) were recruited over a duration of 6 months. In total, 155 participant dyads were randomized into the intervention and control groups, each. The primary outcome of control of three major risk factors revealed that at 12 months, there was a greater percentage of participants with a systolic BP<125 mm Hg (18/54, 33% vs 11/52, 21%; P=.16), diastolic BP<85 mm Hg (44/54, 81% vs 37/52, 71%; P=.21), HbA 1c level<7% (36/55, 65% vs 30/40, 75%; P=.32), and low-density lipoprotein level<100 mg/dL (36/51, 70% vs 30/45, 67%; P=.68) in the intervention group than in the control group. The secondary outcome reported is the mortality among the stroke survivors because the number of stroke-related complications was higher in the control group than in the intervention group (13/155, 8.4% vs 2/155, 1.3%), and this difference was statistically significant (P<.001). CONCLUSIONS The Movies4Stroke trial failed to achieve its primary specified outcome. However, secondary outcomes that directly related to survival skills of stroke survivors demonstrated the effectiveness of the video-based intervention on improving stroke-related mortality and survival without disability. TRIAL REGISTRATION ClinicalTrials.gov NCT02202330; https://www.clinicaltrials.gov/ct2/show/NCT02202330.",2020,"(36/51, 70% vs 30/45, 67%; P=.68) in the intervention group than in the control group.","['participants (stroke survivor-caregiver dyads) with first-ever stroke (both ischemic and hemorrhagic) incidence', '155 participant dyads', '310 stroke survivors and their caregiver dyads (participant dyads']","['video education intervention', '5-Minute Movies Shown via a Mobile Phone App', 'video-based education intervention group or the control group', 'Stroke Caregiver Dyad Education Intervention (Movies4Stroke', 'video-based education intervention', 'standardized care including predischarge education and counseling according to defined protocols']","['stroke-related mortality and survival without disability', 'mortality among the stroke survivors because the number of stroke-related complications', 'diastolic BP<85 mm Hg', 'systolic BP<125 mm Hg', 'survival skills of stroke survivors', 'effectiveness and safety', 'Risk Factors and Mortality', 'proportion of participants achieving control of blood pressure, blood sugar, and blood cholesterol', 'mortality and functional disability', 'control of three major risk factors']","[{'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0475224', 'cui_str': 'Ischemic (qualifier value)'}, {'cui': 'C0333275', 'cui_str': 'Hemorrhagic (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}]","[{'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0681495', 'cui_str': 'Movies'}, {'cui': 'C1136360', 'cui_str': 'Mobile Phone'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0085537', 'cui_str': 'Care Givers'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}]","[{'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C0518017', 'cui_str': 'Blood cholesterol'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}]",310.0,0.164838,"(36/51, 70% vs 30/45, 67%; P=.68) in the intervention group than in the control group.","[{'ForeName': 'Ayeesha', 'Initials': 'A', 'LastName': 'Kamal', 'Affiliation': 'Aga Khan University, Stroke Services and Research, Karachi, Pakistan.'}, {'ForeName': 'Adeel', 'Initials': 'A', 'LastName': 'Khoja', 'Affiliation': 'Aga Khan University, Stroke Services and Research, Karachi, Pakistan.'}, {'ForeName': 'Bushra', 'Initials': 'B', 'LastName': 'Usmani', 'Affiliation': 'Aga Khan University, Stroke Services and Research, Karachi, Pakistan.'}, {'ForeName': 'Shahvaiz', 'Initials': 'S', 'LastName': 'Magsi', 'Affiliation': 'Aga Khan University, Stroke Services and Research, Karachi, Pakistan.'}, {'ForeName': 'Aresha', 'Initials': 'A', 'LastName': 'Malani', 'Affiliation': 'Aga Khan University, Stroke Services and Research, Karachi, Pakistan.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Peera', 'Affiliation': 'Aga Khan University, Stroke Services and Research, Karachi, Pakistan.'}, {'ForeName': 'Saadia', 'Initials': 'S', 'LastName': 'Sattar', 'Affiliation': 'Aga Khan University, Stroke Services and Research, Karachi, Pakistan.'}, {'ForeName': 'Masood', 'Initials': 'M', 'LastName': 'Ahmed Akram', 'Affiliation': 'Aga Khan University, Stroke Services and Research, Karachi, Pakistan.'}, {'ForeName': 'Sumaira', 'Initials': 'S', 'LastName': 'Shahnawaz', 'Affiliation': 'Aga Khan University, Stroke Services and Research, Karachi, Pakistan.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Zulfiqar', 'Affiliation': 'Aga Khan University, Stroke Services and Research, Karachi, Pakistan.'}, {'ForeName': 'Abdul', 'Initials': 'A', 'LastName': 'Muqeet', 'Affiliation': 'Aga Khan Development Network, Digital Health Resource Center, Karachi, Pakistan.'}, {'ForeName': 'Fabiha', 'Initials': 'F', 'LastName': 'Zaidi', 'Affiliation': 'Aga Khan Development Network, Digital Health Resource Center, Karachi, Pakistan.'}, {'ForeName': 'Saleem', 'Initials': 'S', 'LastName': 'Sayani', 'Affiliation': 'Aga Khan Development Network, Digital Health Resource Center, Karachi, Pakistan.'}, {'ForeName': 'Azmina', 'Initials': 'A', 'LastName': 'Artani', 'Affiliation': 'Aga Khan University, Stroke Services and Research, Karachi, Pakistan.'}, {'ForeName': 'Iqbal', 'Initials': 'I', 'LastName': 'Azam', 'Affiliation': 'Aga Khan University, Community Health Sciences, Karachi, Pakistan.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Saleem', 'Affiliation': 'Aga Khan University, Community Health Sciences, Karachi, Pakistan.'}]",JMIR mHealth and uHealth,['10.2196/12113'] 1560,32437328,Physical Activity With Tailored mHealth Support for Individuals With Intellectual Disabilities: Protocol for a Randomized Controlled Trial.,"BACKGROUND Individuals with intellectual disabilities (IDs) have lower levels of physical activity (PA) and greater barriers for participation in fitness activities compared with members of the general population. As increased PA has positive effects on cardiovascular and psychosocial health, it is exceedingly important to identify effective interventions for use in everyday settings. Mobile health (mHealth) methods such as motion sensor games (exergames) and smartphone reminders for PA have been explored and found to be promising in individuals with IDs. OBJECTIVE The purpose of this study is to examine the effectiveness of an individually tailored PA program with motivational mHealth support on daily levels of PA in youth and adults with IDs. METHODS The trial uses a randomized controlled design comprising 30 intervention participants and 30 control group participants, aged 16 to 60 years, with sedentary lifestyles or low PA levels. While the controls will receive standard care, the intervention aims to increase the level of PA, measured as steps per day, as the primary outcome. Secondary outcome variables are body mass index, blood pressure, physical performance, social support for PA, self-efficacy in a PA setting, behavior problems, and goal attainment. The intervention involves the delivery of tailored mHealth support, using smartphones or tablets to create structure with focus on the communicative abilities of individual participants. Rewards and feedback are provided in order to motivate individuals to increase participation in PA. Participants in the intervention group, their close relatives, and care staff will be invited to participate in a preintervention goal-setting meeting, where goal attainment scaling will be used to select the participants' PA goals for the intervention period. All participants will be assessed at baseline, at 3 months, and at 6 months. RESULTS Enrollment was planned to start in April 2020 but will be delayed due to the pandemic situation. The main contribution of this paper is a detailed plan to run our study, which will produce new knowledge about tailored mHealth to support PA in individuals with intellectual disabilities. CONCLUSIONS We expect the new intervention to perform better than standard care in terms of improved PA, improved self-efficacy, and social support for activities. Technology offers new opportunities to promote healthy behaviors. The results of the study will determine the effectiveness and sustainability of a tailored mHealth support intervention to increase PA in youth and adults with IDs. TRIAL REGISTRATION ClinicalTrials.gov NCT04079439; https://clinicaltrials.gov/ct2/show/NCT04079439. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID) PRR1-10.2196/19213.",2020,"We expect the new intervention to perform better than standard care in terms of improved PA, improved self-efficacy and social support for activities.","['30 intervention participants and 30 controls, aged 16 to 60 years, with a sedentary lifestyle or low PA level', 'individuals with IDs', 'youth and adults with IDs', 'individuals with intellectual disabilities', 'Individuals with intellectual disabilities (IDs']",[],"['Physical activity', 'blood pressure, physical performance, social support for PA, self-efficacy in PA setting, behavior problems and goal attainment']","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1532253', 'cui_str': 'Sedentary lifestyle'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C3714756', 'cui_str': 'Intellectual disability'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]",[],"[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0233514', 'cui_str': 'Abnormal behavior'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}]",30.0,0.0665167,"We expect the new intervention to perform better than standard care in terms of improved PA, improved self-efficacy and social support for activities.","[{'ForeName': 'Henriette', 'Initials': 'H', 'LastName': 'Michalsen', 'Affiliation': 'Department of Rehabilitation, University Hospital of North Norway, Tromsø, Norway.'}, {'ForeName': 'Silje Camilla', 'Initials': 'SC', 'LastName': 'Wangberg', 'Affiliation': 'Department of Health and Care Sciences, University of Tromsø - The Arctic University of Norway, Narvik, Norway.'}, {'ForeName': 'Gunnar', 'Initials': 'G', 'LastName': 'Hartvigsen', 'Affiliation': 'Department of Computer Science, University of Tromsø - The Artic University of Norway, Tromsø, Norway.'}, {'ForeName': 'Letizia', 'Initials': 'L', 'LastName': 'Jaccheri', 'Affiliation': 'Department of Computer Science, The Norwegian University of Science and Technology, Trondheim, Norway.'}, {'ForeName': 'Miroslav', 'Initials': 'M', 'LastName': 'Muzny', 'Affiliation': 'Department of Rehabilitation, University Hospital of North Norway, Tromsø, Norway.'}, {'ForeName': 'André', 'Initials': 'A', 'LastName': 'Henriksen', 'Affiliation': 'Department of Community Medicine, University of Tromsø - The Arctic University of Norway, Tromsø, Norway.'}, {'ForeName': 'Monica Isabel', 'Initials': 'MI', 'LastName': 'Olsen', 'Affiliation': 'Department of Rehabilitation, University Hospital of North Norway, Tromsø, Norway.'}, {'ForeName': 'Gyrd', 'Initials': 'G', 'LastName': 'Thrane', 'Affiliation': 'Department of Health and Care Sciences, University of Tromsø - The Arctic University of Norway, Tromsø, Norway.'}, {'ForeName': 'Reidun Birgitta', 'Initials': 'RB', 'LastName': 'Jahnsen', 'Affiliation': 'Department of Neurosciences for Children, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Gunn', 'Initials': 'G', 'LastName': 'Pettersen', 'Affiliation': 'Department of Health and Care Sciences, University of Tromsø - The Arctic University of Norway, Tromsø, Norway.'}, {'ForeName': 'Cathrine', 'Initials': 'C', 'LastName': 'Arntzen', 'Affiliation': 'Department of Rehabilitation, University Hospital of North Norway, Tromsø, Norway.'}, {'ForeName': 'Audny', 'Initials': 'A', 'LastName': 'Anke', 'Affiliation': 'Department of Rehabilitation, University Hospital of North Norway, Tromsø, Norway.'}]",JMIR research protocols,['10.2196/19213'] 1561,30485400,Safety of guselkumab in patients with moderate-to-severe psoriasis treated through 100 weeks: a pooled analysis from the randomized VOYAGE 1 and VOYAGE 2 studies.,"BACKGROUND Long-term evaluation is required to confirm the safety profile of newer biologic agents. OBJECTIVES To report on pooled safety data from the ongoing VOYAGE 1 (NCT02207231) and VOYAGE 2 (NCT02207244) trials through 100 weeks of follow-up. METHODS Patients were randomized to either guselkumab 100 mg at weeks 0 and 4 and every 8 weeks thereafter; placebo at weeks 0, 4, 12 followed by guselkumab 100 mg at weeks 16 and 20 and every 8 weeks thereafter; or adalimumab 80 mg at week 0, 40 mg at week 1, and 40 mg every 2 weeks thereafter. Patients who received adalimumab crossed over to guselkumab at week 52 (VOYAGE 1) and at/after week 28 based on clinical response (VOYAGE 2). Open-label extensions, in which all patients received guselkumab, started at week 52 (VOYAGE 1) and week 76 (VOYAGE 2). Rates of adverse events (AEs) per 100 patient-years (PYs) are presented through 100 weeks of follow-up. RESULTS Through week 52, observed rates for guselkumab- and adalimumab-treated patients, respectively, were 262·45 per 100 PYs and 328·28 per 100 PYs for AEs, 6·20 per 100 PYs and 7·77 per 100 PYs for serious AEs (SAEs), 1·22 per 100 PYs and 1·79 per 100 PYs for serious infections (SIs), 0·28 per 100 PYs and 0·40 per 100 PYs for malignancies other than nonmelanoma skin cancers (NMSCs), 0·56 per 100 PYs and 0·40 per 100 PYs for NMSCs, and 0·47 per 100 PYs and 0·40 per 100 PYs for major adverse cardiovascular events (MACEs). Rates among patients treated with guselkumab through week 52 and week 100, respectively, were 262·45 per 100 PYs and 210·41 per 100 PYs for AEs, 6·20 and 6·29 per 100 PYs, for SAEs, 1·22 per 100 PYs and 1·06 per 100 PYs for SIs, 0·28 per 100 PYs and 0·38 per 100 PYs for malignancies, 0·56 per 100 PYs and 0·39 per 100 PYs for NMSCs, and 0·47 per 100 PYs and 0·38 per 100 PYs for MACEs. Among patients treated with adalimumab, rates of AEs, SAEs, SIs, malignancies, NMSCs, and MACEs showed some variability before and after crossover to guselkumab, although no new safety signals were noted after crossover. CONCLUSIONS The safety profile for guselkumab remains favourable through 100 weeks of treatment in patients with moderate-to-severe psoriasis.",2019,"Among patients treated with adalimumab, rates of AEs, SAEs, SIs, malignancies, NMSCs, and MACEs showed some variability before and after crossover to guselkumab, although no new safety signals were noted after crossover. ","['Patients', 'patients with moderate-to-severe psoriasis treated through 100 weeks', 'patients with moderate-to-severe psoriasis']","['adalimumab', 'guselkumab', 'placebo', 'adalimumab crossed over to guselkumab']","['rates of AEs, SAEs, SIs, malignancies, NMSCs, and MACEs', 'Rates of adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C1122087', 'cui_str': 'adalimumab'}, {'cui': 'C3852217', 'cui_str': 'guselkumab'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0010366', 'cui_str': 'Crossing Over, Genetic'}]","[{'cui': 'C0349381', 'cui_str': 'Mace (substance)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.0604302,"Among patients treated with adalimumab, rates of AEs, SAEs, SIs, malignancies, NMSCs, and MACEs showed some variability before and after crossover to guselkumab, although no new safety signals were noted after crossover. ","[{'ForeName': 'K', 'Initials': 'K', 'LastName': 'Reich', 'Affiliation': 'Dermatologikum Berlin and SCIderm Research Institute, Hamburg, Germany.'}, {'ForeName': 'K A', 'Initials': 'KA', 'LastName': 'Papp', 'Affiliation': 'K Papp Clinical Research and Probity Research, Inc., Waterloo, Canada.'}, {'ForeName': 'A W', 'Initials': 'AW', 'LastName': 'Armstrong', 'Affiliation': 'University of Southern California, Los Angeles, CA, U.S.A.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Wasfi', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, PA, U.S.A.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, PA, U.S.A.'}, {'ForeName': 'Y K', 'Initials': 'YK', 'LastName': 'Shen', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, PA, U.S.A.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Randazzo', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, PA, U.S.A.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Song', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, PA, U.S.A.'}, {'ForeName': 'A B', 'Initials': 'AB', 'LastName': 'Kimball', 'Affiliation': 'Harvard Medical School and Beth Israel Deaconess Medical Center, Inc., Boston, MA, U.S.A.'}]",The British journal of dermatology,['10.1111/bjd.17454'] 1562,31427751,"Effects of immunomodulatory drugs on depressive symptoms: A mega-analysis of randomized, placebo-controlled clinical trials in inflammatory disorders.","Activation of the innate immune system is commonly associated with depression. Immunomodulatory drugs may have efficacy for depressive symptoms that are co-morbidly associated with inflammatory disorders. We report a large-scale re-analysis by standardized procedures (mega-analysis) of patient-level data combined from 18 randomized clinical trials conducted by Janssen or GlaxoSmithKline for one of nine disorders (N = 10,743 participants). Core depressive symptoms (low mood, anhedonia) were measured by the Short Form Survey (SF-36) or the Hospital Anxiety and Depression Scale (HADS), and participants were stratified into high (N = 1921) versus low-depressive strata based on baseline ratings. Placebo-controlled change from baseline after 4-16 weeks of treatment was estimated by the standardized mean difference (SMD) over all trials and for each subgroup of trials targeting one of 7 mechanisms (IL-6, TNF-α, IL-12/23, CD20, COX2, BLγS, p38/MAPK14). Patients in the high depressive stratum showed modest but significant effects on core depressive symptoms (SMD = 0.29, 95% CI [0.12-0.45]) and related SF-36 measures of mental health and vitality. Anti-IL-6 antibodies (SMD = 0.8, 95% CI [0.20-1.41]) and an anti-IL-12/23 antibody (SMD = 0.48, 95% CI [0.26-0.70]) had larger effects on depressive symptoms than other drug classes. Adjustments for physical health outcome marginally attenuated the average treatment effect on depressive symptoms (SMD = 0.20, 95% CI: 0.06-0.35), but more strongly attenuated effects on mental health and vitality. Effects of anti-IL-12/23 remained significant and anti-IL-6 antibodies became a trend after controlling for physical response to treatment. Novel immune-therapeutics can produce antidepressant effects in depressed patients with primary inflammatory disorders that are not entirely explained by treatment-related changes in physical health.",2020,Effects of anti-IL-12/23 remained significant and anti-IL-6 antibodies became a trend after controlling for physical response to treatment.,"['depressed patients with primary inflammatory disorders', 'for one of nine disorders (N\u2009=\u200910,743 participants']","['Placebo', 'placebo', 'immunomodulatory drugs', 'Janssen or GlaxoSmithKline']","['depressive symptoms', 'Anti-IL-6 antibodies', 'mental health and vitality', 'core depressive symptoms', 'related SF-36 measures of mental health and vitality', 'Core depressive symptoms (low mood, anhedonia', 'Hospital Anxiety and Depression Scale (HADS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1290884', 'cui_str': 'Inflammatory disorder'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}]","[{'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0444669', 'cui_str': 'Core (qualifier value)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0344315', 'cui_str': 'Depressed'}, {'cui': 'C0178417', 'cui_str': 'Anhedonia'}, {'cui': 'C0451221', 'cui_str': 'Hospital anxiety and depression scale (assessment scale)'}, {'cui': 'C0048008', 'cui_str': 'Benzenamine, 4-((4-aminophenyl)sulfonyl)-N-hydroxy-'}]",,0.398153,Effects of anti-IL-12/23 remained significant and anti-IL-6 antibodies became a trend after controlling for physical response to treatment.,"[{'ForeName': 'Gayle M', 'Initials': 'GM', 'LastName': 'Wittenberg', 'Affiliation': 'Neuroscience, Janssen Research & Development, LLC, Titusville, NJ, USA. gwittenb@its.jnj.com.'}, {'ForeName': 'Annie', 'Initials': 'A', 'LastName': 'Stylianou', 'Affiliation': 'Clinical Statistics, GlaxoSmithKline R&D, Stevenage, UK.'}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Neuroscience, Janssen Research & Development, LLC, Titusville, NJ, USA.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'Neuroscience, Janssen Research & Development, LLC, Titusville, NJ, USA.'}, {'ForeName': 'Ashutosh', 'Initials': 'A', 'LastName': 'Gupta', 'Affiliation': 'Clinical Statistics, GlaxoSmithKline R&D, Bangalore, India.'}, {'ForeName': 'P S', 'Initials': 'PS', 'LastName': 'Jagannatha', 'Affiliation': 'Clinical Statistics, GlaxoSmithKline R&D, Bangalore, India.'}, {'ForeName': 'Dai', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': 'Neuroscience, Janssen Research & Development, LLC, Titusville, NJ, USA.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Hsu', 'Affiliation': 'Immunology, Janssen Research & Development, LLC, Spring House, PA, USA.'}, {'ForeName': 'Mark E', 'Initials': 'ME', 'LastName': 'Curran', 'Affiliation': 'Immunology, Janssen Research & Development, LLC, Spring House, PA, USA.'}, {'ForeName': 'Shahid', 'Initials': 'S', 'LastName': 'Khan', 'Affiliation': 'ImmunoPsychiatry, Immuno-Inflammation Therapeutic Area Unit, GlaxoSmithKline R&D, Stevenage, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'Guang', 'Initials': 'G', 'LastName': 'Chen', 'Affiliation': 'Neuroscience, Janssen Research & Development, LLC, La Jolla, CA, USA.'}, {'ForeName': 'Edward T', 'Initials': 'ET', 'LastName': 'Bullmore', 'Affiliation': 'ImmunoPsychiatry, Immuno-Inflammation Therapeutic Area Unit, GlaxoSmithKline R&D, Stevenage, UK.'}, {'ForeName': 'Wayne C', 'Initials': 'WC', 'LastName': 'Drevets', 'Affiliation': 'Neuroscience, Janssen Research & Development, LLC, La Jolla, CA, USA.'}]",Molecular psychiatry,['10.1038/s41380-019-0471-8'] 1563,31422216,Nivolumab versus investigator's choice in patients with recurrent or metastatic squamous cell carcinoma of the head and neck: Efficacy and safety in CheckMate 141 by age.,"OBJECTIVES Many patients with squamous cell carcinoma of the head and neck (SCCHN) are ≥65 years old; comorbidities and other age-related factors may affect their ability to tolerate traditional chemotherapy. Nivolumab is the only immunotherapy to significantly improve overall survival (OS) versus investigator's choice (IC) of single-agent chemotherapy at primary analysis in a phase 3 trial (CheckMate 141) in patients with recurrent/metastatic SCCHN post-platinum therapy. In this post hoc analysis, we report efficacy and safety by age. PATIENTS AND METHODS Eligible patients were randomized 2:1 to nivolumab 3 mg/kg every 2 weeks (n = 240) or IC (methotrexate, docetaxel, or cetuximab n = 121). The primary endpoint of the trial was OS. For this analysis, outcomes were analyzed by age < 65 and ≥65 years. The data cut-off date was September 2017 (minimum follow-up 24.2 months). RESULTS At baseline, 68 patients (28.3%) receiving nivolumab and 45 patients (37.2%) receiving IC were ≥65 years. Baseline characteristics were generally similar across age groups. OS and tumor response benefits with nivolumab versus IC were maintained regardless of age. The 30-month OS rates of 11.2% (<65 years) and 13.0% (≥65 years) with nivolumab were more than tripled versus corresponding IC rates of 1.4% and 3.3%, respectively. The nivolumab arm had a lower rate of treatment-related adverse events versus IC regardless of age, consistent with the overall patient population. CONCLUSION In CheckMate 141, nivolumab resulted in a higher survival versus IC in patients <65 and ≥65 years, with a manageable safety profile in both age groups. ClinicalTrials.gov: NCT02105636.",2019,"In CheckMate 141, nivolumab resulted in a higher survival versus IC in patients <65 and ≥65 years, with a manageable safety profile in both age groups.","['patients with recurrent or metastatic squamous cell carcinoma of the head and neck', 'Eligible patients', 'patients with squamous cell carcinoma of the head and neck (SCCHN) are ≥65\u202fyears old; comorbidities and other age-related factors', 'patients with recurrent/metastatic SCCHN post-platinum therapy']","['nivolumab 3\u202fmg/kg every 2\u202fweeks (n\u202f=\u202f240) or IC (methotrexate, docetaxel, or cetuximab n\u202f=\u202f121', 'nivolumab versus IC', 'Nivolumab']","['overall survival (OS', 'rate of treatment-related adverse events', '30-month OS rates']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0334246', 'cui_str': 'Squamous cell carcinoma, metastatic (morphologic abnormality)'}, {'cui': 'C0018670', 'cui_str': 'Head'}, {'cui': 'C0027536', 'cui_str': 'Necking (finding)'}, {'cui': 'C1168401', 'cui_str': 'Squamous cell carcinoma of head and neck (disorder)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C4319600', 'cui_str': '240 (qualifier value)'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0995188', 'cui_str': 'cetuximab'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]",68.0,0.213077,"In CheckMate 141, nivolumab resulted in a higher survival versus IC in patients <65 and ≥65 years, with a manageable safety profile in both age groups.","[{'ForeName': 'Nabil F', 'Initials': 'NF', 'LastName': 'Saba', 'Affiliation': 'Winship Cancer Institute of Emory University, 1365-C Clifton Road NE, Atlanta, GA 30322, USA. Electronic address: nfsaba@emory.edu.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Blumenschein', 'Affiliation': 'MD Anderson Cancer Center, 1515 Holcombe Blvd., Houston, TX 77030, USA. Electronic address: gblumens@mdanderson.org.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Guigay', 'Affiliation': ""Centre Antoine Lacassagne, FHU OncoAge, Université Côte d'Azur, 33 Avenue de Valombrose, Nice 06189, France. Electronic address: joel.guigay@nice.unicancer.fr.""}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Licitra', 'Affiliation': 'Fondazione IRCCS Istituto Nazionale dei Tumori and University of Milan, via Venezian 1, Milan 20133, Italy. Electronic address: lisa.licitra@istitutotumori.mi.it.'}, {'ForeName': 'Jerome', 'Initials': 'J', 'LastName': 'Fayette', 'Affiliation': 'Centre Leon Berard, 28 Prom. Léa et Napoléon Bullukian, Lyon 69008, France. Electronic address: jerome.fayette@lyon.unicancer.fr.'}, {'ForeName': 'Kevin J', 'Initials': 'KJ', 'LastName': 'Harrington', 'Affiliation': 'Royal Marsden NHS Foundation Trust/The Institute of Cancer Research, Fulham Road, London SW3 6JJ, UK. Electronic address: kevin.harrington@icr.ac.uk.'}, {'ForeName': 'Naomi', 'Initials': 'N', 'LastName': 'Kiyota', 'Affiliation': 'Kobe University Hospital Cancer Center, 7 Chome-5-2 Kusunokicho, Chuo Ward, Kobe 650-0017, Japan. Electronic address: nkiyota@med.kobe-u.ac.jp.'}, {'ForeName': 'Maura L', 'Initials': 'ML', 'LastName': 'Gillison', 'Affiliation': 'MD Anderson Cancer Center, 1515 Holcombe Blvd., Houston, TX 77030, USA. Electronic address: mgillison@mdanderson.org.'}, {'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Ferris', 'Affiliation': 'University of Pittsburgh Medical Center Hillman Cancer Center, 5115 Centre Ave., Pittsburgh, PA 15232, USA. Electronic address: ferrisrl@upmc.edu.'}, {'ForeName': 'Vijayvel', 'Initials': 'V', 'LastName': 'Jayaprakash', 'Affiliation': 'Bristol-Myers Squibb, 3401 Princeton Pike, Lawrenceville 08648, NJ, USA. Electronic address: Vijayvel.Jayaprakash@bms.com.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Bristol-Myers Squibb, 3401 Princeton Pike, Lawrenceville 08648, NJ, USA. Electronic address: Li.Li6@bms.com.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Brossart', 'Affiliation': 'University Hospital of Bonn, Sigmund-Freud-Straße 25, Bonn 53127, Germany. Electronic address: Peter.Brossart@ukbonn.de.'}]",Oral oncology,['10.1016/j.oraloncology.2019.06.017'] 1564,31937856,Vitamin D Supplementation in Overweight/obese Asian Indian Women with Prediabetes Reduces Glycemic Measures and Truncal Subcutaneous Fat: A 78 Weeks Randomized Placebo-Controlled Trial (PREVENT-WIN Trial).,"Vitamin D deficiency may contribute to etiology of type 2 diabetes in Asian Indians. The objectives of this study was to evaluate effect of vitamin D supplementation on glycemic profile and body composition in prediabetic and vitamin D deficient overweight/obese Asian Indian women. In this open-label randomized placebo-controlled trial (78 weeks duration), 121 females (aged 20-60 years) with prediabetes and vitamin D deficiency were randomly allocated in intervention (n, 61) and placebo (n, 60) groups. The primary outcome variables were fasting blood glucose (FBG), 2-h blood glucose post OGTT (2-h BG), hemoglobin A1c (HbA1C), and reversal to normoglycemia. In Intention-to-treat analysis, at the end of intervention, we observed significant decrease in FBG [-5.0 (-12.6-2.4), p = 0.04], 2-h blood glucose post OGTT [-11(-49.3-26.9), p = 0.02], hemoglobin A1c [-0.41 (5.89, 6.55), p = 0.05] and increase in 25(OH) D [7.5 (-6.0-20.9), p = 0.002] levels in intervention as compared to the placebo group. Changes in glycemic category based on FBG were as follows; intervention group: normal FBG, 58.6%; impaired fasting glucose (IFG), 39%; and type 2 diabetes mellitus (T2DM), 2.4%; placebo group: normal FBG, 48.8%; IFG, 46.3%; and T2DM, 4.9%. Changes in category of 2-hour glucose post OGTT after intervention were as follows; intervention group: normal glucose tolerance (NGT) 51.2% and prediabetes, 48.8%; placebo group: NGT, 43.9%; prediabetes, 53.7% and T2DM, 2.4%. After intervention, subscapular skinfold (visit I st compared to visit III rd ) and suprailiac skinfold (visit II nd compared to visit III rd ) were significantly lower in intervention group vs. control group. In conclusion, we observed significant reduction in FBG, 2-hour glucose post OGTT, HbA1c, and truncal subcutaneous fat and reversal to normoglycemia in overweight/obese prediabetic vitamin D deficient Asian Indian women after 78 weeks of vitamin D supplementation.",2020,"Changes in category of 2-hour glucose post OGTT after intervention were as follows; intervention group: normal glucose tolerance (NGT) 51.2% and prediabetes, 48.8%; placebo group: NGT, 43.9%; prediabetes, 53.7% and T2DM, 2.4%.","['prediabetic and vitamin D deficient overweight/obese Asian Indian women', 'Overweight/obese Asian Indian Women with Prediabetes Reduces Glycemic Measures and Truncal Subcutaneous Fat', '121 females (aged 20-60 years) with prediabetes and vitamin D deficiency']","['Placebo', 'Vitamin D deficiency', 'vitamin D supplementation', 'Vitamin D Supplementation', 'placebo']","['FBG', 'fasting glucose (IFG', 'subscapular skinfold (visit I st compared to visit III rd ) and suprailiac skinfold', 'normal glucose tolerance', 'hemoglobin A1c', 'glycemic category based on\xa0FBG', 'FBG, 2-hour glucose post OGTT, HbA1c, and truncal subcutaneous fat and reversal to normoglycemia', 'glycemic profile and body composition', 'fasting blood glucose (FBG), 2-h blood glucose post OGTT (2-h BG), hemoglobin A1c (HbA1C), and reversal to normoglycemia', '25(OH']","[{'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C0011155', 'cui_str': 'Deficient (qualifier value)'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0078988', 'cui_str': 'Asians'}, {'cui': 'C1524069', 'cui_str': 'Indian (racial group)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0362046', 'cui_str': 'Prediabetes'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0222331', 'cui_str': 'Subcutaneous Fat'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0042870', 'cui_str': 'Vitamin D Deficiency'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0042870', 'cui_str': 'Vitamin D Deficiency'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}]","[{'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0231197', 'cui_str': 'Tolerance, function (observable entity)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C4521595', 'cui_str': 'Lcpl'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C1292425', 'cui_str': '2 hours (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C0222331', 'cui_str': 'Subcutaneous Fat'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0011744', 'cui_str': 'Hydrogen-2'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}]",,0.0943356,"Changes in category of 2-hour glucose post OGTT after intervention were as follows; intervention group: normal glucose tolerance (NGT) 51.2% and prediabetes, 48.8%; placebo group: NGT, 43.9%; prediabetes, 53.7% and T2DM, 2.4%.","[{'ForeName': 'Surya Prakash', 'Initials': 'SP', 'LastName': 'Bhatt', 'Affiliation': 'Diabetes Foundation (India), Safdarjung Development Area, New Delhi, 110016, India.'}, {'ForeName': 'Anoop', 'Initials': 'A', 'LastName': 'Misra', 'Affiliation': 'Diabetes Foundation (India), Safdarjung Development Area, New Delhi, 110016, India. anoopmisra@gmail.com.'}, {'ForeName': 'Ravindra Mohan', 'Initials': 'RM', 'LastName': 'Pandey', 'Affiliation': 'Biostatistics, All India Institute of Medical Sciences, Ansari Nagar, New Delhi, 110029, India.'}, {'ForeName': 'Ashish Datt', 'Initials': 'AD', 'LastName': 'Upadhyay', 'Affiliation': 'Biostatistics, All India Institute of Medical Sciences, Ansari Nagar, New Delhi, 110029, India.'}, {'ForeName': 'Seema', 'Initials': 'S', 'LastName': 'Gulati', 'Affiliation': 'Diabetes Foundation (India), Safdarjung Development Area, New Delhi, 110016, India.'}, {'ForeName': 'Namrata', 'Initials': 'N', 'LastName': 'Singh', 'Affiliation': 'Diabetes Foundation (India), Safdarjung Development Area, New Delhi, 110016, India.'}]",Scientific reports,['10.1038/s41598-019-56904-y'] 1565,31804894,Phase III Trial of Adjuvant Capecitabine After Standard Neo-/Adjuvant Chemotherapy in Patients With Early Triple-Negative Breast Cancer (GEICAM/2003-11_CIBOMA/2004-01).,"PURPOSE Operable triple-negative breast cancers (TNBCs) have a higher risk of relapse than non-TNBCs with standard therapy. The GEICAM/2003-11_CIBOMA/2004-01 trial explored extended adjuvant capecitabine after completion of standard chemotherapy in patients with early TNBC. PATIENTS AND METHODS Eligible patients were those with operable, node-positive-or node negative with tumor 1 cm or greater-TNBC, with prior anthracycline- and/or taxane-containing chemotherapy. After central confirmation of TNBC status by immunohistochemistry, patients were randomly assigned to either capecitabine or observation. Stratification factors included institution, prior taxane-based therapy, involved axillary lymph nodes, and centrally determined phenotype (basal v nonbasal, according to cytokeratins 5/6 and/or epidermal growth factor receptor positivity by immunohistochemistry). The primary objective was to compare disease-free survival (DFS) between both arms. RESULTS Eight hundred seventy-six patients were randomly assigned to capecitabine (n = 448) or observation (n = 428). Median age was 49 years, 55.9% were lymph node negative, 73.9% had a basal phenotype, and 67.5% received previous anthracyclines plus taxanes. Median length of follow-up was 7.3 years. DFS was not significantly prolonged with capecitabine versus observation [hazard ratio (HR), 0.82; 95% CI, 0.63 to 1.06; P = .136]. In a preplanned subgroup analysis, nonbasal patients seemed to derive benefit from the addition of capecitabine with a DFS HR of 0.53 versus 0.94 in those with basal phenotype (interaction test P = .0694) and an HR for overall survival of 0.42 versus 1.23 in basal phenotype (interaction test P = .0052). Tolerance of capecitabine was as expected, with 75.2% of patients completing the planned 8 cycles. CONCLUSION This study failed to show a statistically significant increase in DFS by adding extended capecitabine to standard chemotherapy in patients with early TNBC. In a preplanned subset analysis, patients with nonbasal phenotype seemed to obtain benefit with capecitabine, although this will require additional validation.",2020,"DFS was not significantly prolonged with capecitabine versus observation [hazard ratio (HR), 0.82; 95% CI, 0.63 to 1.06; P = .136].","['Patients With Early Triple-Negative Breast Cancer', 'Eligible patients were those with operable, node-positive-or node negative with tumor 1 cm or greater-TNBC, with prior', 'Median age was 49 years, 55.9% were lymph node negative, 73.9% had a basal phenotype, and 67.5% received previous', 'Eight hundred seventy-six patients', 'patients with early TNBC']","['Adjuvant Capecitabine', 'anthracycline- and/or taxane-containing chemotherapy', 'anthracyclines plus taxanes', 'capecitabine or observation', 'capecitabine', 'Standard Neo-/Adjuvant Chemotherapy']","['Median length', 'DFS', 'disease-free survival (DFS', 'overall survival']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C3539878', 'cui_str': 'Triple Negative Breast Cancer'}, {'cui': 'C0205188', 'cui_str': 'Operable (qualifier value)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0647859', 'cui_str': 'AM49'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0024204', 'cui_str': 'Lymphatic gland'}, {'cui': 'C0205112', 'cui_str': 'Basal (qualifier value)'}, {'cui': 'C1314763', 'cui_str': 'Phenotyping (qualifier value)'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C3844106', 'cui_str': 'Eight hundred'}, {'cui': 'C4319622', 'cui_str': 'Seventy-six'}]","[{'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C0282564', 'cui_str': 'Anthracyclines'}, {'cui': 'C0796419', 'cui_str': 'Taxanes'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",876.0,0.122436,"DFS was not significantly prolonged with capecitabine versus observation [hazard ratio (HR), 0.82; 95% CI, 0.63 to 1.06; P = .136].","[{'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Lluch', 'Affiliation': 'Hospital Clínico Universitario de Valencia and Biomedical Research Institute INCLIVA, University of Valencia, Valencia, Spain.'}, {'ForeName': 'Carlos H', 'Initials': 'CH', 'LastName': 'Barrios', 'Affiliation': 'Centro de Pesquisa Clínica Hospital São Lucas da PUCRS, Porto Alegre, Brazil.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Torrecillas', 'Affiliation': 'Centro Médico Nacional 20 de Noviembre, Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado, Ciudad de México, México.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Ruiz-Borrego', 'Affiliation': 'GEICAM, Spanish Breast Cancer Group, Madrid, Spain.'}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Bines', 'Affiliation': 'LACOG, Latin American Cooperative Oncology Group, Porto Alegre, Brazil.'}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Segalla', 'Affiliation': 'LACOG, Latin American Cooperative Oncology Group, Porto Alegre, Brazil.'}, {'ForeName': 'Ángel', 'Initials': 'Á', 'LastName': 'Guerrero-Zotano', 'Affiliation': 'GEICAM, Spanish Breast Cancer Group, Madrid, Spain.'}, {'ForeName': 'Jose A', 'Initials': 'JA', 'LastName': 'García-Sáenz', 'Affiliation': 'GEICAM, Spanish Breast Cancer Group, Madrid, Spain.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Torres', 'Affiliation': 'Instituto Nacional del Cáncer, Santiago, Chile.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'de la Haba', 'Affiliation': 'Centro de Investigación Biomédica en Red de Oncología ISCIII, Madrid, Spain.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'García-Martínez', 'Affiliation': 'GEICAM, Spanish Breast Cancer Group, Madrid, Spain.'}, {'ForeName': 'Henry L', 'Initials': 'HL', 'LastName': 'Gómez', 'Affiliation': 'Instituto Nacional de Enfermedades Neoplásicas, Lima, Perú.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Llombart', 'Affiliation': 'GEICAM, Spanish Breast Cancer Group, Madrid, Spain.'}, {'ForeName': 'Javier Salvador', 'Initials': 'JS', 'LastName': 'Bofill', 'Affiliation': 'GEICAM, Spanish Breast Cancer Group, Madrid, Spain.'}, {'ForeName': 'José M', 'Initials': 'JM', 'LastName': 'Baena-Cañada', 'Affiliation': 'GEICAM, Spanish Breast Cancer Group, Madrid, Spain.'}, {'ForeName': 'Agustí', 'Initials': 'A', 'LastName': 'Barnadas', 'Affiliation': 'Centro de Investigación Biomédica en Red de Oncología ISCIII, Madrid, Spain.'}, {'ForeName': 'Lourdes', 'Initials': 'L', 'LastName': 'Calvo', 'Affiliation': 'GEICAM, Spanish Breast Cancer Group, Madrid, Spain.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Pérez-Michel', 'Affiliation': 'Hospital de San José, Ciudad Obregón, Sonora, México.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Ramos', 'Affiliation': 'GEICAM, Spanish Breast Cancer Group, Madrid, Spain.'}, {'ForeName': 'Isaura', 'Initials': 'I', 'LastName': 'Fernández', 'Affiliation': 'GEICAM, Spanish Breast Cancer Group, Madrid, Spain.'}, {'ForeName': 'Álvaro', 'Initials': 'Á', 'LastName': 'Rodríguez-Lescure', 'Affiliation': 'GEICAM, Spanish Breast Cancer Group, Madrid, Spain.'}, {'ForeName': 'Jesús', 'Initials': 'J', 'LastName': 'Cárdenas', 'Affiliation': 'Centro Médico Colima, Colima, México.'}, {'ForeName': 'Jeferson', 'Initials': 'J', 'LastName': 'Vinholes', 'Affiliation': 'LACOG, Latin American Cooperative Oncology Group, Porto Alegre, Brazil.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Martínez de Dueñas', 'Affiliation': 'GEICAM, Spanish Breast Cancer Group, Madrid, Spain.'}, {'ForeName': 'Maria J', 'Initials': 'MJ', 'LastName': 'Godes', 'Affiliation': 'GEICAM, Spanish Breast Cancer Group, Madrid, Spain.'}, {'ForeName': 'Miguel A', 'Initials': 'MA', 'LastName': 'Seguí', 'Affiliation': 'GEICAM, Spanish Breast Cancer Group, Madrid, Spain.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Antón', 'Affiliation': 'GEICAM, Spanish Breast Cancer Group, Madrid, Spain.'}, {'ForeName': 'Pilar', 'Initials': 'P', 'LastName': 'López-Álvarez', 'Affiliation': 'GEICAM, Spanish Breast Cancer Group, Madrid, Spain.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Moncayo', 'Affiliation': 'Social S Hospital Teodoro Maldonado Carbo, Guayaquil, Ecuador.'}, {'ForeName': 'Gilberto', 'Initials': 'G', 'LastName': 'Amorim', 'Affiliation': 'LACOG, Latin American Cooperative Oncology Group, Porto Alegre, Brazil.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Villar', 'Affiliation': 'GEICAM, Spanish Breast Cancer Group, Madrid, Spain.'}, {'ForeName': 'Salvador', 'Initials': 'S', 'LastName': 'Reyes', 'Affiliation': 'Hospital Beneficiencia Española, San Luis de Potosí, México.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Sampaio', 'Affiliation': 'LACOG, Latin American Cooperative Oncology Group, Porto Alegre, Brazil.'}, {'ForeName': 'Bernardita', 'Initials': 'B', 'LastName': 'Cardemil', 'Affiliation': 'Hospital Base de Valdivia, Valdivia, Chile.'}, {'ForeName': 'Maria J', 'Initials': 'MJ', 'LastName': 'Escudero', 'Affiliation': 'GEICAM, Spanish Breast Cancer Group, Madrid, Spain.'}, {'ForeName': 'Susana', 'Initials': 'S', 'LastName': 'Bezares', 'Affiliation': 'GEICAM, Spanish Breast Cancer Group, Madrid, Spain.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Carrasco', 'Affiliation': 'GEICAM, Spanish Breast Cancer Group, Madrid, Spain.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Martín', 'Affiliation': 'Centro de Investigación Biomédica en Red de Oncología ISCIII, Madrid, Spain.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.00904'] 1566,32441473,Semaglutide 2.4 mg for the Treatment of Obesity: Key Elements of the STEP Trials 1 to 5.,"OBJECTIVE The obesity epidemic is a public health concern, warranting further research into pharmacological treatments for weight management (WM) as an adjunct to lifestyle interventions. The Semaglutide Treatment Effect in People with obesity (STEP) program aims to investigate the effect of semaglutide versus placebo on weight loss, safety, and tolerability in adults with obesity or overweight. METHODS Across five phase 3 trials (NCT03548935, WM; NCT03552757, WM in type 2 diabetes; NCT03611582, WM with intensive behavioral therapy; NCT03548987, sustained WM; and NCT03693430, long-term WM), ~5,000 participants are being randomly assigned to receive semaglutide 2.4 mg once weekly subcutaneously versus placebo. Results will be available in 2020/2021. For all trials, the primary end point is change from baseline to end of treatment in body weight. RESULTS Participants have a mean age of 46.2 to 55.3 years, are mostly female (mean: 74.1%-81.0%), and have a mean BMI of 35.7 to 38.5 kg/m 2 and a mean waist circumference of 113.0 to 115.7 cm. CONCLUSIONS The STEP program evaluates the efficacy and safety of semaglutide 2.4 mg subcutaneously once weekly in a broad population. The trials will provide insights on WM in people with obesity with and without type 2 diabetes and on long-term follow-up.",2020,"The Semaglutide Treatment Effect in People with obesity (STEP) program aims to investigate the effect of semaglutide versus placebo on weight loss, safety, and tolerability in adults with obesity or overweight. ","['Participants have a mean age of 46.2 to 55.3 years, are mostly female (mean: 74.1%-81.0%), and have a mean BMI of 35.7 to 38.5 kg/m 2 and a mean waist circumference of 113.0 to 115.7 cm', '5,000 participants', 'people with obesity with and without type 2 diabetes and on long-term follow-up', 'adults with obesity or overweight', 'People with obesity (STEP) program']","['semaglutide 2.4 mg once weekly subcutaneously versus placebo', 'semaglutide versus placebo']","['body weight', 'efficacy and safety', 'weight loss, safety, and tolerability']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C3885068', 'cui_str': 'semaglutide'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C3885068', 'cui_str': 'semaglutide'}, {'cui': 'C4517631', 'cui_str': '2.4'}, {'cui': 'C0558293', 'cui_str': 'Once a week'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}]",,0.0600766,"The Semaglutide Treatment Effect in People with obesity (STEP) program aims to investigate the effect of semaglutide versus placebo on weight loss, safety, and tolerability in adults with obesity or overweight. ","[{'ForeName': 'Robert F', 'Initials': 'RF', 'LastName': 'Kushner', 'Affiliation': 'Division of Endocrinology, Feinberg School of Medicine, Northwestern University, Chicago, Illinois, USA.'}, {'ForeName': 'Salvatore', 'Initials': 'S', 'LastName': 'Calanna', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Davies', 'Affiliation': 'Diabetes Research Centre, University of Leicester, Leicester, UK.'}, {'ForeName': 'Dror', 'Initials': 'D', 'LastName': 'Dicker', 'Affiliation': 'Department of Internal Medicine, Hasharon Hospital Rabin Medical Center, Petah Tikva, Israel.'}, {'ForeName': 'W Timothy', 'Initials': 'WT', 'LastName': 'Garvey', 'Affiliation': 'Department of Nutrition Sciences, University of Alabama at Birmingham, Birmingham, Alabama, USA.'}, {'ForeName': 'Bryan', 'Initials': 'B', 'LastName': 'Goldman', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Ildiko', 'Initials': 'I', 'LastName': 'Lingvay', 'Affiliation': 'Department of Internal Medicine/Endocrinology, UT Southwestern Medical Center, Dallas, Texas, USA.'}, {'ForeName': 'Mette', 'Initials': 'M', 'LastName': 'Thomsen', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Thomas A', 'Initials': 'TA', 'LastName': 'Wadden', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'Wharton', 'Affiliation': 'York University and Wharton Weight Management Clinic, Toronto, Ontario, Canada.'}, {'ForeName': 'John P H', 'Initials': 'JPH', 'LastName': 'Wilding', 'Affiliation': 'Obesity and Endocrinology Research, Institute of Ageing and Chronic Disease, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Domenica', 'Initials': 'D', 'LastName': 'Rubino', 'Affiliation': 'Washington Center for Weight Management and Research, Arlington, Virginia, USA.'}]","Obesity (Silver Spring, Md.)",['10.1002/oby.22794'] 1567,31439338,Antithrombotic Therapy and Cardiovascular Outcomes After Transcatheter Aortic Valve Replacement in Patients With Atrial Fibrillation.,"OBJECTIVES The study sought to determine the patterns of antithrombotic therapy and association with clinical outcomes in patients with atrial fibrillation (AF) and CHA 2 DS 2 -VASc (congestive heart failure, hypertension, age ≥75 years, diabetes mellitus, prior stroke or transient ischemic attack or thromboembolism, vascular disease, age 65-74 years, sex category) score ≥2 following transcatheter aortic valve replacement (TAVR). BACKGROUND The impact of antithrombotic regimens on clinical outcomes in patients with AF and severe aortic stenosis treated with TAVR is unknown. METHODS In the randomized PARTNER II (Placement of Aortic Transcatheter Valve II) trial and associated registries, 1,621 patients with prior AF and CHA 2 DS 2 -VASc score ≥2 comprised the study cohort. Outcomes were analyzed according to antithrombotic therapy. RESULTS During the 5-year enrollment period, 933 (57.6%) patients were discharged on oral anticoagulant therapy (OAC). Uninterrupted antiplatelet therapy (APT) for at least 6 months or until an endpoint event was used in 544 of 933 (58.3%) of patients on OAC and 77.5% of patients not on OAC. At 2 years, patients on OAC had a similar rate of stroke (6.6% vs. 5.6%; p = 0.53) and the composite outcome of death or stroke (29.7% vs. 31.8%; p = 0.33), compared with no OAC. OAC with APT was associated with a reduced rate of stroke (5.4% vs. 11.1%; p = 0.03) and death or stroke (29.7% vs. 40.1%; p = 0.01), compared with no OAC or APT. Following adjustment, OAC with APT and APT alone were both associated with reduced rates of stroke compared with no OAC or APT (hazard ratio for OAC+APT: 0.43, 95% confidence interval: 0.22 to 0.85; p = 0.015; hazard ratio for APT alone: 0.32, 95% confidence interval: 0.16 to 0.65; p = 0.002), while OAC alone was not. CONCLUSIONS Among patients with prior AF undergoing TAVR, antiplatelet with or without anticoagulant therapy was associated with a reduced risk of stroke at 2 years, implicating multifactorial stroke mechanisms in this population.",2019,"Following adjustment, OAC with APT and APT alone were both associated with reduced rates of stroke compared with no OAC or APT (hazard ratio for OAC+APT: 0.43, 95% confidence interval: 0.22 to 0.85; p = 0.015; hazard ratio for APT alone: 0.32, 95% confidence interval: 0.16 to 0.65; p = 0.002), while OAC alone was not. ","['1,621 patients with prior AF and CHA 2 DS 2 -VASc score\xa0≥2 comprised the study cohort', 'patients with prior AF undergoing TAVR, antiplatelet with or without', 'patients with atrial fibrillation (AF) and CHA 2 DS 2 -VASc (congestive heart failure, hypertension, age\xa0≥75 years, diabetes mellitus, prior stroke or transient ischemic attack or thromboembolism, vascular disease, age 65-74 years, sex category) score\xa0≥2 following transcatheter aortic valve replacement (TAVR', 'Patients With Atrial Fibrillation', 'patients with AF and severe aortic stenosis treated with TAVR is unknown']","['antithrombotic regimens', 'Transcatheter Aortic Valve Replacement', 'oral anticoagulant therapy (OAC', 'anticoagulant therapy', 'Uninterrupted antiplatelet therapy (APT']","['death or stroke', 'rate of stroke', 'rates of stroke', 'Antithrombotic Therapy and Cardiovascular Outcomes', 'composite outcome of death or stroke']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}, {'cui': 'C0018802', 'cui_str': 'Congestive heart failure (disorder)'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0007787', 'cui_str': 'Brain TIA'}, {'cui': 'C0040038', 'cui_str': 'Thromboembolism'}, {'cui': 'C0042373', 'cui_str': 'Vascular Diseases'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C2711836', 'cui_str': 'TAVR - Transcatheter aortic valve replacement'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0003507', 'cui_str': 'Aortic Stenosis'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0439673', 'cui_str': 'Unknown (qualifier value)'}]","[{'cui': 'C2711836', 'cui_str': 'TAVR - Transcatheter aortic valve replacement'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0150457', 'cui_str': 'Anticoagulant therapy (procedure)'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}, {'cui': 'C0003645', 'cui_str': 'APT'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}]",1621.0,0.0749304,"Following adjustment, OAC with APT and APT alone were both associated with reduced rates of stroke compared with no OAC or APT (hazard ratio for OAC+APT: 0.43, 95% confidence interval: 0.22 to 0.85; p = 0.015; hazard ratio for APT alone: 0.32, 95% confidence interval: 0.16 to 0.65; p = 0.002), while OAC alone was not. ","[{'ForeName': 'Ioanna', 'Initials': 'I', 'LastName': 'Kosmidou', 'Affiliation': 'Clinical Trials Center, Cardiovascular Research Foundation, New York, New York; Department of Medicine, NewYork-Presbyterian Hospital/Columbia University Medical Center, New York, New York. Electronic address: ik2394@cumc.columbia.edu.'}, {'ForeName': 'Yangbo', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Clinical Trials Center, Cardiovascular Research Foundation, New York, New York.'}, {'ForeName': 'Maria C', 'Initials': 'MC', 'LastName': 'Alu', 'Affiliation': 'Department of Medicine, NewYork-Presbyterian Hospital/Columbia University Medical Center, New York, New York.'}, {'ForeName': 'Mengdan', 'Initials': 'M', 'LastName': 'Liu', 'Affiliation': 'Clinical Trials Center, Cardiovascular Research Foundation, New York, New York.'}, {'ForeName': 'Mahesh', 'Initials': 'M', 'LastName': 'Madhavan', 'Affiliation': 'Clinical Trials Center, Cardiovascular Research Foundation, New York, New York; Department of Medicine, NewYork-Presbyterian Hospital/Columbia University Medical Center, New York, New York.'}, {'ForeName': 'Tarun', 'Initials': 'T', 'LastName': 'Chakravarty', 'Affiliation': 'Department of Medicine, Cedars-Sinai Medical Center, Los Angeles, California.'}, {'ForeName': 'Raj', 'Initials': 'R', 'LastName': 'Makkar', 'Affiliation': 'Department of Medicine, Cedars-Sinai Medical Center, Los Angeles, California.'}, {'ForeName': 'Vinod H', 'Initials': 'VH', 'LastName': 'Thourani', 'Affiliation': 'Department of Cardiac Surgery, Medstar Heart and Vascular Institute/Georgetown University, Washington, DC.'}, {'ForeName': 'Angelo', 'Initials': 'A', 'LastName': 'Biviano', 'Affiliation': 'Department of Medicine, NewYork-Presbyterian Hospital/Columbia University Medical Center, New York, New York.'}, {'ForeName': 'Susheel', 'Initials': 'S', 'LastName': 'Kodali', 'Affiliation': 'Clinical Trials Center, Cardiovascular Research Foundation, New York, New York; Department of Medicine, NewYork-Presbyterian Hospital/Columbia University Medical Center, New York, New York.'}, {'ForeName': 'Martin B', 'Initials': 'MB', 'LastName': 'Leon', 'Affiliation': 'Clinical Trials Center, Cardiovascular Research Foundation, New York, New York; Department of Medicine, NewYork-Presbyterian Hospital/Columbia University Medical Center, New York, New York.'}]",JACC. Cardiovascular interventions,['10.1016/j.jcin.2019.06.001'] 1568,31344528,Cariprazine for the treatment of bipolar mania with mixed features: A post hoc pooled analysis of 3 trials.,"BACKGROUND When bipolar I disorder (BP-I) mania is accompanied by subsyndromal depressive symptoms, a more complicated illness presentation results. To qualify for the mixed features specifier during mania, the DSM-5 requires ≥3 ""non-overlapping"" depressive symptoms (DS); notwithstanding, concerns of this definition's ecological validity and implications for timely diagnosis remain. METHODS Herein, patients were pooled from three similarly-designed pivotal trials of cariprazine compared to placebo for BP-I mania (NCT00488618/NCT01058096/NCT01058668) in post hoc analyses of mixed features using three criteria: ≥3 DS (DSM-5), ≥2 DS, and Montgomery-Åsberg Depression Rating Scale (MADRS) total score ≥10. Efficacy of cariprazine compared to placebo was assessed (Week 3) by Young Mania Rating Scale (YMRS) and MADRS scores and rates of mania response and remission. RESULTS In pooled patients (N = 1037), cariprazine significantly improved mean YMRS scores compared to placebo for each criterion; LSMDs were ≥3 DS = -3.79 (P = .0248), ≥2 DS = -2.91 (P = .0207), and ≥10 MADRS = -5.49 (P < .0001). More cariprazine- than placebo-treated patients met YMRS response and remission criteria, reaching significance for response in ≥2 DS (34% versus 47%; number-needed-to-treat [NNT] = 8, P = .0483) and ≥10 MADRS (31% versus 57%, NNT = 4, P < .0001) and for remission in ≥2 DS (27% versus 39%, NNT = 9, P = .0462), ≥10 MADRS (23% versus 44%, NNT = 5, P < .0001). Depressive symptoms were improved compared to placebo, reaching statistical significance in the MADRS ≥10 subgroup (LSMD = -1.59, P = .0082). LIMITATIONS Post hoc analysis, MADRS  < 18 entry criterion may have prevented assessment of MADRS changes. CONCLUSIONS Cariprazine significantly reduced manic and depressive symptoms in patients with mixed features with differential efficacy across the subgroups analyzed herein.",2019,"In pooled patients (N = 1037), cariprazine significantly improved mean YMRS scores compared to placebo for each criterion; LSMDs were ≥3 DS = -3.79 (P = .0248), ≥2 DS = -2.91 (P = .0207), and ≥10 MADRS = -5.49 (P < .0001).","['Herein, patients were pooled from three similarly-designed pivotal trials of', 'bipolar mania with mixed features']","['placebo', 'Cariprazine', 'cariprazine']","['Depressive symptoms', 'remission in ≥2 DS', 'Young Mania Rating Scale (YMRS) and MADRS scores and rates of mania response and remission', 'YMRS response and remission criteria', 'DS (DSM-5), ≥2 DS, and Montgomery-Åsberg Depression Rating Scale (MADRS) total score ≥10', 'mean YMRS scores', 'manic and depressive symptoms']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0337051', 'cui_str': 'Pool (environment)'}, {'cui': 'C0443156', 'cui_str': 'Bipolar (qualifier value)'}, {'cui': 'C0338831', 'cui_str': 'Manic State'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2936870', 'cui_str': 'cariprazine'}]","[{'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C4087288', 'cui_str': 'Young mania rating scale'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0338831', 'cui_str': 'Manic State'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C2960593', 'cui_str': 'Montgomery-Åsberg depression rating scale'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",18.0,0.228583,"In pooled patients (N = 1037), cariprazine significantly improved mean YMRS scores compared to placebo for each criterion; LSMDs were ≥3 DS = -3.79 (P = .0248), ≥2 DS = -2.91 (P = .0207), and ≥10 MADRS = -5.49 (P < .0001).","[{'ForeName': 'Roger S', 'Initials': 'RS', 'LastName': 'McIntyre', 'Affiliation': 'Mood Disorders Psychopharmacology Unit, University Health Network, 399 Bathurst Street, MP 9-325, Toronto, ON M5T 2S8, Canada; Brain Cognition Discovery Foundation, Toronto, Ontario, Canada. Electronic address: roger.mcintyre@uhn.ca.'}, {'ForeName': 'Prakash S', 'Initials': 'PS', 'LastName': 'Masand', 'Affiliation': 'Centers of Psychiatric Excellence, New York, New York, United States.'}, {'ForeName': 'Willie', 'Initials': 'W', 'LastName': 'Earley', 'Affiliation': 'Allergan plc, Madison, NJ, United States.'}, {'ForeName': 'Mehul', 'Initials': 'M', 'LastName': 'Patel', 'Affiliation': 'Allergan plc, Madison, NJ, United States.'}]",Journal of affective disorders,['10.1016/j.jad.2019.07.020'] 1569,31930018,Active surveillance of ventilator-associated pneumonia in the intensive care unit and establishment of the risk grading system and effect evaluation.,"Background To discuss ventilator-associated pneumonia (VAP) patient's clinical characteristic and related factors in the intensive care unit (ICU), and to establish a risk grading system for VAP patients in the ICU in order to provide a reference for VAP prevention. Methods A total of 1,513 patients in eight ICUs who received mechanical ventilation between June 2015 and June 2018 were randomized and into two groups, with 908 patients in the model group and 605 patients in the verification group. The model group was used to analyze the influencing factors of VAP and establish a risk grading system, while the verification group was used to verify the risk grading system. A receiver operating characteristic (ROC) curve was used to evaluate the predictive effect of the grading system. Results During the 3-year study period, of the 1,513 total patients, 188 patients were infected with VAP, leading to an incidence rate of 12.43% (188/1,513) and an infection rate of 15.23‰ (188/12,347). ICU length of stay, mechanical ventilation days, frequency of oral care, unused subglottic secretion drainage, tracheotomy, APACHE II score, and combined antibiotics use were risk factors of VAP infection for patients who received mechanical ventilation in the modeling group (P<0.05). In a VAP risk-grading system established based on risk factors, the high, medium and low-grade patients had a statistically significantly different VAP infection rate in the model group, and patients with a high grade had a higher risk of VAP infection. Patients' data in the model and verification groups were used to draw a ROC curve which showed a good predictive effect. Conclusions This study establishes and verifies the VAP risk grading system for patients who receive mechanical ventilation. It is helpful in high-risk patient surveillance and in reducing and preventing VAP infection.",2019,"During the 3-year study period, of the 1,513 total patients, 188 patients were infected with VAP, leading to an incidence rate of 12.43% (188/1,513) and an infection rate of 15.23‰ (188/12,347).","['1,513 total patients, 188 patients were infected with VAP, leading to an incidence rate of 12.43% (188/1,513) and an infection rate of 15.23‰ (188/12,347', 'patients who receive mechanical ventilation', '1,513 patients in eight ICUs who received mechanical ventilation between June 2015 and June 2018 were randomized and into two groups, with 908 patients in the model group and 605 patients in the verification group']",[],"['ICU length of stay, mechanical ventilation days, frequency of oral care, unused subglottic secretion drainage, tracheotomy, APACHE II score, and combined antibiotics use were risk factors of VAP infection', 'VAP infection rate']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0199470', 'cui_str': 'Mechanically assisted ventilation'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}]",[],"[{'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0199470', 'cui_str': 'Mechanically assisted ventilation'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0036537', 'cui_str': 'Secretions'}, {'cui': 'C0013103', 'cui_str': 'Drainage'}, {'cui': 'C0040591', 'cui_str': 'Tracheotomy'}, {'cui': 'C0489438', 'cui_str': 'APACHE II score'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C3714514', 'cui_str': 'Infection'}]",1513.0,0.0231236,"During the 3-year study period, of the 1,513 total patients, 188 patients were infected with VAP, leading to an incidence rate of 12.43% (188/1,513) and an infection rate of 15.23‰ (188/12,347).","[{'ForeName': 'Weiping', 'Initials': 'W', 'LastName': 'Liu', 'Affiliation': ""Department of Nosocomial Infection Control, Inner Mongolia People's Hospital, Hohhot 010017, China.""}, {'ForeName': 'Yueying', 'Initials': 'Y', 'LastName': 'Jiao', 'Affiliation': ""Department of Nosocomial Infection Control, Inner Mongolia People's Hospital, Hohhot 010017, China.""}, {'ForeName': 'Huimin', 'Initials': 'H', 'LastName': 'Xing', 'Affiliation': ""Department of Nosocomial Infection Control, Inner Mongolia People's Hospital, Hohhot 010017, China.""}, {'ForeName': 'Yunting', 'Initials': 'Y', 'LastName': 'Hai', 'Affiliation': ""Department of Nosocomial Infection Control, Inner Mongolia People's Hospital, Hohhot 010017, China.""}, {'ForeName': 'Haoxue', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': ""Department of Nosocomial Infection Control, Inner Mongolia People's Hospital, Hohhot 010017, China.""}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Zhang', 'Affiliation': ""Department of Nosocomial Infection Control, Inner Mongolia People's Hospital, Hohhot 010017, China.""}, {'ForeName': 'Yuping', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': ""Department of Nosocomial Infection Control, Inner Mongolia People's Hospital, Hohhot 010017, China.""}, {'ForeName': 'Yongfang', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': ""Department of Nosocomial Infection Control, Inner Mongolia People's Hospital, Hohhot 010017, China.""}, {'ForeName': 'Binbin', 'Initials': 'B', 'LastName': 'Xu', 'Affiliation': ""Department of Nosocomial Infection Control, Inner Mongolia People's Hospital, Hohhot 010017, China.""}, {'ForeName': 'Haibo', 'Initials': 'H', 'LastName': 'Bai', 'Affiliation': ""Department of Nosocomial Infection Control, Inner Mongolia People's Hospital, Hohhot 010017, China.""}, {'ForeName': 'Huan', 'Initials': 'H', 'LastName': 'Bao', 'Affiliation': ""Department of Nosocomial Infection Control, Inner Mongolia People's Hospital, Hohhot 010017, China.""}, {'ForeName': 'Shuai', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': ""Department of Nosocomial Infection Control, Inner Mongolia People's Hospital, Hohhot 010017, China.""}, {'ForeName': 'Tianhui', 'Initials': 'T', 'LastName': 'Guo', 'Affiliation': ""Department of Nosocomial Infection Control, Inner Mongolia People's Hospital, Hohhot 010017, China.""}]",Annals of translational medicine,['10.21037/atm.2019.11.25'] 1570,31416897,Heterogeneity of Treatment Effects From an Intensive Lifestyle Weight Loss Intervention on Cardiovascular Events in Patients With Type 2 Diabetes: Data From the Look AHEAD Trial.,"OBJECTIVE To explore the presence of heterogeneity of treatment effect (HTE) of an intensive lifestyle intervention on the occurrence of major cardiovascular events (MACE) in overweight or obese patients with type 2 diabetes, and to identify patient characteristics associated with individual treatment effect. RESEARCH DESIGN AND METHODS In 4,901 participants from the Action for Health in Diabetes (Look AHEAD) trial, a penalized Cox regression model to predict treatment effect of intensive lifestyle intervention for the risk of MACE was derived, including all possible treatment-by-covariate interaction terms. The ability of the model to predict HTE was confirmed by calculating hazard ratios (HRs) and absolute risk change in quartiles of predicted treatment effect, and baseline patient characteristics were compared between quartiles. RESULTS In quartile 1 of predicted treatment effect, with the highest predicted risk reduction, there was a significant treatment benefit of intensive lifestyle intervention (HR 0.64 [95% CI 0.49-0.83]), whereas there was no effect from treatment in quartiles 2 and 3 (HR 0.81 [95% CI 0.58-1.14] and 1.13 [95% CI 0.80-1.60], respectively) and a detrimental effect in quartile 4 (HR 1.37 [95% CI 1.09-1.73]). Several patient characteristics in demographics, medical history, physical examination, and laboratory values were associated with the level of treatment effect. CONCLUSIONS This post hoc analysis of the Look AHEAD trial showed that an intensive lifestyle intervention aimed at weight loss may reduce cardiovascular events in selected patients but may have a detrimental treatment effect in others.",2019,,['Patients With Type 2 Diabetes'],['Intensive Lifestyle Weight Loss Intervention'],['Cardiovascular Events'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}]","[{'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}]",,0.172102,,"[{'ForeName': 'Tamar I', 'Initials': 'TI', 'LastName': 'de Vries', 'Affiliation': 'Department of Vascular Medicine, University Medical Center Utrecht, Utrecht, the Netherlands.'}, {'ForeName': 'Jannick A N', 'Initials': 'JAN', 'LastName': 'Dorresteijn', 'Affiliation': 'Department of Vascular Medicine, University Medical Center Utrecht, Utrecht, the Netherlands.'}, {'ForeName': 'Yolanda', 'Initials': 'Y', 'LastName': 'van der Graaf', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands.'}, {'ForeName': 'Frank L J', 'Initials': 'FLJ', 'LastName': 'Visseren', 'Affiliation': 'Department of Vascular Medicine, University Medical Center Utrecht, Utrecht, the Netherlands.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Westerink', 'Affiliation': 'Department of Vascular Medicine, University Medical Center Utrecht, Utrecht, the Netherlands j.westerink-3@umcutrecht.nl.'}]",Diabetes care,['10.2337/dc19-0776'] 1571,30839304,Efficacy of deep core stability exercise program in postpartum women with diastasis recti abdominis: a randomised controlled trial.,"OBJECTIVES This study was aimed at discovering the efficacy the deep core stability exercise program has on the closure of diastasis recti and on the overall improvement in the quality of life for postpartum women. METHODS The study group consisted of forty women with diastasis recti, aged between 23 and 33 who were randomly divided into two groups. The 20 women in the first group underwent a deep core stability-strengthening program plus traditional abdominal exercises program, 3 times a week, for a total duration of 8 weeks. The other 20 women, forming the second group, only underwent the traditional abdominal exercises program, 3 times a week for 8 weeks. Following this procedure, the inter-recti separation was measured using digital nylon calipers while the quality of life was measured by Physical Functioning Scale (PF10) for all the participants. RESULTS As a result of the use of the deep core stability exercise program, inter-recti separation had a high statistically relevant decrease, (P<0.0001), showing a highly statistically relevant improvement with regard to the quality of life in the study groups (p<0.0001). CONCLUSIONS The deep core stability exercise program is effective in treating diastasis recti and improving postpartum women's quality of life.",2019,The deep core stability exercise program is effective in treating diastasis recti and improving postpartum women's quality of life.,"['20 women in the first group underwent a', 'postpartum women', 'forty women with diastasis recti, aged between 23 and 33 who', 'postpartum women with diastasis recti abdominis']","['deep core stability exercise program', 'deep core stability-strengthening program plus traditional abdominal exercises program', 'traditional abdominal exercises program']","['Physical Functioning Scale (PF10', 'quality of life']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0032804', 'cui_str': 'Postpartum Women'}, {'cui': 'C0221766', 'cui_str': 'Diastasis recti (disorder)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0444669', 'cui_str': 'Core (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}, {'cui': 'C0454354', 'cui_str': 'Abdominal exercises (regime/therapy)'}]","[{'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0222045'}, {'cui': 'C0034380'}]",40.0,0.0429497,The deep core stability exercise program is effective in treating diastasis recti and improving postpartum women's quality of life.,"[{'ForeName': 'Ali A', 'Initials': 'AA', 'LastName': 'Thabet', 'Affiliation': 'Department of Physical Therapy for Gynaecology and Obstetrics, Faculty of Physical Therapy, Cairo University, Giza, Egypt.'}, {'ForeName': 'Mansour A', 'Initials': 'MA', 'LastName': 'Alshehri', 'Affiliation': ''}]",Journal of musculoskeletal & neuronal interactions,[] 1572,32133778,"Bioavailability of Triprolidine as a Single Agent or in Combination With Pseudoephedrine: A Randomized, Open-Label Crossover Study in Healthy Volunteers.","Antihistamines have been in clinical use for more than 70 years to treat allergic and nonallergic symptoms including relief from cold and flu symptoms. Despite their widespread use, pharmacokinetic (PK) data are sparse for older, first-generation antihistamines. This phase 1 single-center open-label, randomized, single-dose, 3-way crossover trial evaluated the PK profiles of 2 doses of film-coated triprolidine caplets (2.5 and 5 mg) compared with a reference combination tablet (triprolidine 2.5 mg + pseudoephedrine 60 mg) in 24 healthy adults. Blood samples were collected predose and at specified intervals across a 24-hour period after administration, and triprolidine was quantified using liquid chromatography-tandem mass spectrometry. Maximum plasma concentration of triprolidine for the 2.5 mg and dose-normalized 5 mg single-agent tablets were comparable (8.4 versus 7.1 ng/mL, respectively) and higher for the combination tablet (9.5 ng/mL). PK parameters, including time to maximum plasma concentration (∼1.5 hours) and elimination half-life (∼4 hours), were comparable between the 3 treatment arms. The safety profile of this sedating antihistamine was as expected; however, adverse effects were reported in a markedly higher proportion of women than men. There were no significant sex differences in any of the measured PK parameters.",2020,There were no significant sex differences in any of the measured PK parameters.,"['Healthy Volunteers', '24 healthy adults']","['sedating antihistamine', 'Antihistamines', 'Pseudoephedrine', 'Triprolidine', 'reference combination tablet (triprolidine 2.5\xa0mg + pseudoephedrine', 'film-coated triprolidine caplets']","['time to maximum plasma concentration', 'adverse effects', 'Bioavailability', 'Maximum plasma concentration of triprolidine']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}]","[{'cui': 'C1955826', 'cui_str': 'Antihistamines, Sedating'}, {'cui': 'C0019590', 'cui_str': 'Antihistamines'}, {'cui': 'C0033798', 'cui_str': 'Pseudoephedrine'}, {'cui': 'C0041098', 'cui_str': 'Triprolidine'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C4319646', 'cui_str': 'Film'}, {'cui': 'C0453946', 'cui_str': 'Coat (physical object)'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0005508', 'cui_str': 'Bioavailability'}, {'cui': 'C0041098', 'cui_str': 'Triprolidine'}]",24.0,0.110154,There were no significant sex differences in any of the measured PK parameters.,"[{'ForeName': 'Salvatore', 'Initials': 'S', 'LastName': 'Febbraro', 'Affiliation': 'PRA Health Sciences, Reading, UK.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Shea', 'Affiliation': 'Reckitt Benckiser Health LLC, Parsippany, New Jersey, USA.'}, {'ForeName': 'Ana Santos', 'Initials': 'AS', 'LastName': 'Cravo', 'Affiliation': 'Reckitt Benckiser Healthcare Ltd, Slough, UK.'}]",Clinical pharmacology in drug development,['10.1002/cpdd.777'] 1573,31430059,Effect of cleaning guidelines implementation on microbial colony count of laparoscopic instruments: A study in a public hospital in Iran.,"INTRODUCTION Some countries have implemented reuse of laparoscopic instruments for cost-effective purposes. An accurate cleaning as the first step of reprocessing would lead to the effective sterilization. The purpose was to evaluate the effect of cleaning guidelines implementation on microbial load of laparoscopic instruments which were used in laparoscopic cholecystectomy surgery. METHODS This experimental study was done in an educational hospital, in 2017 and included a total of 128 laparoscopic instruments randomly selected from cholecystectomy surgeries and divided into two cleaning groups. The instruments were checked out in terms of number (colony-forming units [CFU]/mL) and type of microorganisms in two groups of routine cleaning and according to guideline cleaning. This guideline was indigenous and taken from successful instruction in this context that was presented by the Association for the Advancement of Medical Instrumentation (AAMI). The appropriate statistical analysis was conducted by SPSS version 19. RESULTS The average microbial load was 2.4 × 10 6 CFU/100 mL after clinical use. It was reduced to 7.2 × 10 5 CFU/100 mL in the control group and 3.4 × 10 4 CFU/100 mL in the intervention group, after the cleaning process. The most common microorganisms that were isolated immediately after clinical use were Escherichia coli 81.2%, Pseudomonas 68.8%, Klebsiella 57.8%, and spp., and so on. CONCLUSION The AAMI cleaning method is recommended to be utilized by operating room nurses for laparoscopic instruments.",2020,"The most common microorganisms that were isolated immediately after clinical use were Escherichia coli 81.2%, Pseudomonas 68.8%, Klebsiella 57.8%, and spp., and so on. CONCLUSION ","['educational hospital, in 2017 and included a total of 128 laparoscopic instruments randomly selected from cholecystectomy surgeries and divided into two cleaning groups', 'public hospital in Iran']",['cleaning guidelines implementation'],"['microbial colony count of laparoscopic instruments', 'average microbial load']","[{'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C4551823', 'cui_str': 'instruments'}, {'cui': 'C0008320', 'cui_str': 'Cholecystectomy'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0402683', 'cui_str': 'Cleaner'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0020022', 'cui_str': 'Hospitals, Public'}, {'cui': 'C0022065', 'cui_str': 'Islamic Republic of Iran'}]","[{'cui': 'C0402683', 'cui_str': 'Cleaner'}, {'cui': 'C0220845', 'cui_str': 'guidelines'}]","[{'cui': 'C0009380', 'cui_str': 'Colony-Forming Units Assay, Microbial'}, {'cui': 'C4551823', 'cui_str': 'instruments'}]",128.0,0.027795,"The most common microorganisms that were isolated immediately after clinical use were Escherichia coli 81.2%, Pseudomonas 68.8%, Klebsiella 57.8%, and spp., and so on. CONCLUSION ","[{'ForeName': 'Akram', 'Initials': 'A', 'LastName': 'Aarabi', 'Affiliation': 'Nursing and Midwifery Care Research Center, Operating Room Department, Faculty of Nursing and Midwifery, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Sorour', 'Initials': 'S', 'LastName': 'Mosleh', 'Affiliation': 'Master Science in Perioperative Care, Operating Room Department, Faculty of Nursing and Midwifery, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Fazeli', 'Affiliation': 'Department of Microbiology, Faculty of Medicine, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Hassan', 'Initials': 'H', 'LastName': 'Farahmand', 'Affiliation': 'Faculty Member of the Operating Room Department, Faculty of Nursing and Midwifery, Isfahan University of Medical Sciences, Isfahan, Iran.'}]",Asian journal of endoscopic surgery,['10.1111/ases.12750'] 1574,31944804,"Use of common and unique techniques in the early treatment phase for cognitive-behavioral, interpersonal/emotional, and supportive listening interventions for generalized anxiety disorder.","Psychotherapy research often compares specific treatments to control conditions to establish efficacy of the specified treatment. Research has typically evaluated common factor elements (e.g., credibility, expectancy) in treatments only after the first or second session, largely as a manipulation check and under the assumption that such factors are static. This study observed therapist common factor and model-specific interventions in three treatment approaches from a randomized control trial for generalized anxiety disorder across the entire early phase of treatment (i.e., first five sessions). The parent randomized control trial compared two treatment conditions, using an additive design where patients were randomized to receive either interpersonal/emotional processing interventions or supportive listening after receiving a session of cognitive-behavioral therapy. The first five video-recorded sessions of N = 40 randomly sampled participants were observationally coded with a multidimensional intervention measure, with subscales reflecting diverse theoretical orientations and common factors. Multilevel modeling was used to examine intervention use and investigate differences between treatment conditions and segments. Among the results, common factor interventions were rated as significantly more typical in cognitive-behavioral therapy compared with supportive listening. The pattern of intervention use of other subscales was generally consistent with the orientation of the respective protocols. In the early phase of treatment, supportive listening conditions do not appear to function as common factor controls in the manner that many might assume. Common factors are potentially enhanced in bona fide treatments that include a more detailed, specific rationale and clear and cohesive techniques and goals. (PsycINFO Database Record (c) 2020 APA, all rights reserved).",2020,"Among the results, common factor interventions were rated as significantly more typical in cognitive-behavioral therapy compared with supportive listening.",['generalized anxiety disorder'],"['therapist common factor and model-specific interventions', 'interpersonal/emotional processing interventions or supportive listening after receiving a session of cognitive-behavioral therapy']",[],"[{'cui': 'C0270549', 'cui_str': 'Generalized anxiety disorder (disorder)'}]","[{'cui': 'C0205214', 'cui_str': 'Common (qualifier value)'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}]",[],2020.0,0.0256031,"Among the results, common factor interventions were rated as significantly more typical in cognitive-behavioral therapy compared with supportive listening.","[{'ForeName': 'Brittany R', 'Initials': 'BR', 'LastName': 'King', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'James F', 'Initials': 'JF', 'LastName': 'Boswell', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Carly M', 'Initials': 'CM', 'LastName': 'Schwartzman', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Kyler', 'Initials': 'K', 'LastName': 'Lehrbach', 'Affiliation': 'Department of Emergency Medicine.'}, {'ForeName': 'Louis G', 'Initials': 'LG', 'LastName': 'Castonguay', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Michelle G', 'Initials': 'MG', 'LastName': 'Newman', 'Affiliation': 'Department of Psychology.'}]","Psychotherapy (Chicago, Ill.)",['10.1037/pst0000277'] 1575,31817731,Experimental Outcomes of the Mediterranean Diet: Lessons Learned from the Predimed Randomized Controlled Trial.,"The Mediterranean Diet (MD) is, culturally and historically, the nutritional pattern shared by people living in the olive-tree growing areas of the Mediterranean basin. It is of great importance for its potential preventive effect against cardiovascular diseases (CVDs). The PREvención con DIeta MEDiterránea (PREDIMED) study, a Spanish multicentre randomised controlled trial (RCT), was designed to assess the long-term effects of the MD, without any energy restriction, on the incidence of CVD in individuals at high cardiovascular (CV) risk. Since its inception, it gave a great contribution to the available literature on the issue. It is well known that, in the field of the health sciences, RCTs provide the best scientific evidence. Thus, the aim of the present review is to analyse the results of the RCTs performed within the frame of the PREDIMED study. Our findings showed that MD has beneficial effects in the primary prevention of CVDs, diabetes and in the management of metabolic syndrome.",2019,"Our findings showed that MD has beneficial effects in the primary prevention of CVDs, diabetes and in the management of metabolic syndrome.",['individuals at high cardiovascular (CV) risk'],[],[],"[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}]",[],[],,0.0397252,"Our findings showed that MD has beneficial effects in the primary prevention of CVDs, diabetes and in the management of metabolic syndrome.","[{'ForeName': 'Dicle', 'Initials': 'D', 'LastName': 'Kargin', 'Affiliation': 'Research Institute of Biomedical and Health Sciences, University of Las Palmas de Gran Canaria, 35016 Las Palmas de Gran Canaria, Spain.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Tomaino', 'Affiliation': 'Research Institute of Biomedical and Health Sciences, University of Las Palmas de Gran Canaria, 35016 Las Palmas de Gran Canaria, Spain.'}, {'ForeName': 'Lluís', 'Initials': 'L', 'LastName': 'Serra-Majem', 'Affiliation': 'Research Institute of Biomedical and Health Sciences, University of Las Palmas de Gran Canaria, 35016 Las Palmas de Gran Canaria, Spain.'}]",Nutrients,['10.3390/nu11122991'] 1576,31980638,Comparison of short-acting versus extended-release nifedipine: Effects on hemodynamics and sympathetic activity in patients with stable coronary artery disease.,"We investigated the impact of short-acting and extended release nifedipine on sympathetic activity using radiotracer methodology in patients with stable coronary artery disease in order to more accurately document the response of the sympathetic nervous system to different formulations of this dihydropyridine calcium channel antagonist. Participants were randomized to placebo, short-acting or extended release nifedipine for 7-10 days. On the final day, systemic blood pressure, cardiac filling pressures, cardiac output, plasma norepinephrine (NE) and total body NE spillover were measured at baseline (time 0) and repeated at intervals for 6 hours. There were no differences in baseline measures between groups. Following the morning dose of study medication there were no changes in hemodynamics or sympathetic activity in the placebo group. However, there was a significant fall in blood pressure and a significant increase in total body NE spillover in both nifedipine groups. Importantly, the increase in sympathetic activity in response to short-acting nifedipine began earlier (30 minutes) and was much greater than that observed in the extended release group, which occurred later (270 minutes). These findings confirm that sustained therapy with nifedipine is associated with activation of the sympathetic nervous system which is dependent on the pharmacokinetics of the formulation.",2020,Following the morning dose of study medication there were no changes in hemodynamics or sympathetic activity in the placebo group.,['patients with stable coronary artery disease'],"['short-acting versus extended-release nifedipine', 'placebo, short-acting or extended release nifedipine', 'dihydropyridine calcium channel antagonist', 'nifedipine']","['systemic blood pressure, cardiac filling pressures, cardiac output, plasma norepinephrine (NE) and total body NE spillover', 'sympathetic activity', 'total body NE spillover', 'hemodynamics or sympathetic activity', 'hemodynamics and sympathetic activity', 'blood pressure']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}]","[{'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0231449', 'cui_str': 'Extended (qualifier value)'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0028066', 'cui_str': 'Nifedipine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0220821', 'cui_str': 'dihydropyridine'}, {'cui': 'C0006684', 'cui_str': 'Calcium Channel Blocking Drugs'}]","[{'cui': 'C1272641', 'cui_str': 'Arterial Tension'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0007165', 'cui_str': 'Cardiac Output'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0202145', 'cui_str': 'Norepinephrine measurement (procedure)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}]",,0.0316431,Following the morning dose of study medication there were no changes in hemodynamics or sympathetic activity in the placebo group.,"[{'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Parker', 'Affiliation': 'Department of Pharmacology and Toxicology, University of Toronto, Ontario, Canada. john.parker@uhn.ca.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': ""D' Iorio"", 'Affiliation': 'Division of Cardiology, Department of Medicine Mount Sinai Hospital and The Lunenfeld-Tanenbaum Research Institute, University of Toronto, Ontario, Canada.'}, {'ForeName': 'John S', 'Initials': 'JS', 'LastName': 'Floras', 'Affiliation': 'Division of Cardiology, Department of Medicine Mount Sinai Hospital and The Lunenfeld-Tanenbaum Research Institute, University of Toronto, Ontario, Canada.'}, {'ForeName': 'Corey B', 'Initials': 'CB', 'LastName': 'Toal', 'Affiliation': 'Department of Pharmacology and Toxicology, University of Toronto, Ontario, Canada.'}]",Scientific reports,['10.1038/s41598-019-56890-1'] 1577,30616376,Impact of pre-diagnosis awareness of HIV-related stigma and dispositional coping on linkage to HIV care among newly diagnosed HIV+ Peruvian patients.,"A substantial body of literature has characterized how psychosocial factors, including HIV-related stigma and coping, are associated with HIV testing and HIV care utilization post-diagnosis. Less is known about if certain psychosocial characteristics pre-diagnosis may also predict linkage to care among individuals who receive an HIV-positive diagnosis. We examined if pre-diagnosis awareness/perception about HIV-related stigma and dispositional coping styles predicted linkage to HIV care within three months post-diagnosis with a secondary analysis of 604 patients from a randomized controlled trial (Sabes Study). Awareness/perception about HIV-related stigma, dispositional maladaptive and adaptive coping were measured before patients underwent an HIV test. Linkage to care was measured as receipt of care within three months of receiving the diagnosis. After adjusting for covariates, individuals who reported greater dispositional maladaptive coping pre-diagnosis had lower odds of linking to care, OR = 0.82, 95%CI [0.67, 1.00], p = .05. There was also a non-significant inverse association between dispositional adaptive coping pre-diagnosis and linkage to care. These preliminary data suggest the need for further longitudinal research and highlight the potential utility of pre-diagnosis psychosocial assessment and tailored counseling when providing positive HIV diagnosis results.",2019,"After adjusting for covariates, individuals who reported greater dispositional maladaptive coping pre-diagnosis had lower odds of linking to care, OR = 0.82, 95%CI [0.67, 1.00],","['newly diagnosed HIV+ Peruvian patients', '604 patients']","['HIV-related stigma and dispositional coping', 'pre-diagnosis awareness/perception about HIV-related stigma and dispositional coping styles predicted linkage to HIV care']","['Awareness/perception about HIV-related stigma, dispositional maladaptive and adaptive coping']","[{'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0277787', 'cui_str': 'Stigma (finding)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0004448', 'cui_str': 'Situational Awareness'}, {'cui': 'C0030971', 'cui_str': 'Perception'}]","[{'cui': 'C0004448', 'cui_str': 'Situational Awareness'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0277787', 'cui_str': 'Stigma (finding)'}]",604.0,0.0364575,"After adjusting for covariates, individuals who reported greater dispositional maladaptive coping pre-diagnosis had lower odds of linking to care, OR = 0.82, 95%CI [0.67, 1.00],","[{'ForeName': 'Yamilé', 'Initials': 'Y', 'LastName': 'Molina', 'Affiliation': 'a Community Health Sciences, Center for Research on Women and Gender , University of Illinois at Chicago , Chicago , IL , USA.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Ulrich', 'Affiliation': 'c Vaccine and Infectious Disease & Public Health Science Divisions , Fred Hutchinson Cancer Research Center , Seattle , WA , USA.'}, {'ForeName': 'Anna C', 'Initials': 'AC', 'LastName': 'Greer', 'Affiliation': 'e University of Washington , Seattle , WA , USA.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Primbas', 'Affiliation': 'e University of Washington , Seattle , WA , USA.'}, {'ForeName': 'Grace', 'Initials': 'G', 'LastName': 'Wandell', 'Affiliation': 'e University of Washington , Seattle , WA , USA.'}, {'ForeName': 'Hugo', 'Initials': 'H', 'LastName': 'Sanchez', 'Affiliation': 'g Epicentro , Lima , Peru.'}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Bain', 'Affiliation': 'c Vaccine and Infectious Disease & Public Health Science Divisions , Fred Hutchinson Cancer Research Center , Seattle , WA , USA.'}, {'ForeName': 'Kelika A', 'Initials': 'KA', 'LastName': 'Konda', 'Affiliation': 'i Department of Epidemiology, School of Public Health , University of California Los Angeles , Lima , Peru.'}, {'ForeName': 'Jesse L', 'Initials': 'JL', 'LastName': 'Clark', 'Affiliation': 'j Department of Medicine, Division of Infectious Diseases , University of California Los Angeles , Los Angeles , CA , USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'De la Grecca', 'Affiliation': 'k Asociación Civil Impacta Salud y Educación , Lima , Peru.'}, {'ForeName': 'Manuel V', 'Initials': 'MV', 'LastName': 'Villarán', 'Affiliation': 'k Asociación Civil Impacta Salud y Educación , Lima , Peru.'}, {'ForeName': 'Siavash', 'Initials': 'S', 'LastName': 'Pasalar', 'Affiliation': 'c Vaccine and Infectious Disease & Public Health Science Divisions , Fred Hutchinson Cancer Research Center , Seattle , WA , USA.'}, {'ForeName': 'Javier R', 'Initials': 'JR', 'LastName': 'Lama', 'Affiliation': 'k Asociación Civil Impacta Salud y Educación , Lima , Peru.'}, {'ForeName': 'Ann C', 'Initials': 'AC', 'LastName': 'Duerr', 'Affiliation': 'c Vaccine and Infectious Disease & Public Health Science Divisions , Fred Hutchinson Cancer Research Center , Seattle , WA , USA.'}]",AIDS care,['10.1080/09540121.2018.1563282'] 1578,32437921,Central Review of Radiation Therapy Planning Among Patients with Breast-Conserving Surgery: Results from a Quality Assurance Process Integrated into the INSEMA Trial.,"PURPOSE After publication of the radiation field design in the American College of Surgeons Oncology Group Z0011 trial, a radiation therapy quality assurance review was integrated into the Intergroup-Sentinel-Mamma (INSEMA) trial. We aimed to investigate the role of patient characteristics, extent of axillary surgery, and radiation techniques for dose distribution in ipsilateral axillary levels. METHODS AND MATERIALS INSEMA (NCT02466737) has randomized 5542 patients who underwent breast-conserving surgery. Of these, 276 patients from 108 radiation therapy facilities were included in the central review, using the planning records of the first 3 patients treated at each site. RESULTS Of the 276 patients, 41 had major deviations (ie, no axillary contouring or submission of insufficient records) leading to exclusion. A total of 235 (85.1%) radiation therapy planning records were delineated according to the INSEMA protocol, including 9 (3.8%) cases with minor deviations. At least 25% of INSEMA patients were unintentionally treated with ≥95% of the prescribed breast radiation dose in axillary level I. Approximately 50% of patients were irradiated with a median radiation dose of more than 85% of prescription dose in level I. Irradiated volumes and applied doses were significantly lower in levels II and III compared with level I. However, 25% of patients still received a median radiation dose of ≥75% of prescription dose to level II. Subgroup analysis revealed a significant association between incidental radiation dose in the axilla and obesity. Younger age, boost application, and fractionation schedule showed no impact on axillary dose distribution. CONCLUSIONS Assuming ≥80% of prescribed breast dose as the optimal dose for curative radiation of low-volume disease in axillary lymph nodes, at least 50% of reviewed INSEMA patients received an adequate dose in level I, even with contemporary 3-dimensional techniques. Dose coverage was much less in axillary levels II and III, and far below therapeutically relevant doses.",2020,"Younger age, boost application, and fractionation schedule showed no impact on axillary dose distribution. ","['axillary lymph nodes', '5,542 patients with breast-conserving surgery', '276 patients', '276 patients from 108 radiotherapy facilities were included in the central review using the planning records of the first three patients treated at each site', 'patients with breast-conserving surgery']","['radiation therapy planning', 'XXX']",[],"[{'cui': 'C0729594', 'cui_str': 'Axillary lymph node group'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0917927', 'cui_str': 'Breast conserving surgery'}, {'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning'}, {'cui': 'C2355580', 'cui_str': 'Record of'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0205145', 'cui_str': 'Site'}]","[{'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning'}]",[],5542.0,0.0393912,"Younger age, boost application, and fractionation schedule showed no impact on axillary dose distribution. ","[{'ForeName': 'Guido', 'Initials': 'G', 'LastName': 'Hildebrandt', 'Affiliation': 'Department of Radiotherapy, University of Rostock, Rostock, Germany.'}, {'ForeName': 'Angrit', 'Initials': 'A', 'LastName': 'Stachs', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Rostock, Rostock, Germany.'}, {'ForeName': 'Bernd', 'Initials': 'B', 'LastName': 'Gerber', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Rostock, Rostock, Germany.'}, {'ForeName': 'Jochem', 'Initials': 'J', 'LastName': 'Potenberg', 'Affiliation': 'Breast Center, Evangelisches Waldkrankenhaus Spandau, Berlin, Germany.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Krug', 'Affiliation': 'Department of Radiation Oncology, University Hospital Schleswig-Holstein, Campus Kiel, Kiel, Germany.'}, {'ForeName': 'Kathi', 'Initials': 'K', 'LastName': 'Wolter', 'Affiliation': 'Department of Radiotherapy, University of Rostock, Rostock, Germany.'}, {'ForeName': 'Thorsten', 'Initials': 'T', 'LastName': 'Kühn', 'Affiliation': 'Department of Obstetrics and Gynecology, Interdisciplinary Breast Center, Esslingen, Germany.'}, {'ForeName': 'Dietmar', 'Initials': 'D', 'LastName': 'Zierhut', 'Affiliation': 'Department of Radio-Oncology and Radiotherapy, Klinikum Hanau GmbH, Hanau, Germany.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Sedlmayer', 'Affiliation': 'Department of Radiotherapy and Radio-Oncology, LKH Salzburg, Paracelsus Medical University Clinics, Salzburg, Austria.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Kaiser', 'Affiliation': 'Department of Radiotherapy and Radio-Oncology, LKH Salzburg, Paracelsus Medical University Clinics, Salzburg, Austria.'}, {'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Reitsamer', 'Affiliation': 'Breast Center, LKH Salzburg, Paracelsus Medical University Clinics, Salzburg, Austria.'}, {'ForeName': 'Jörg', 'Initials': 'J', 'LastName': 'Heil', 'Affiliation': 'Breast Unit, University Hospital, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Nekljudova', 'Affiliation': 'German Breast Group, Neu-Isenburg, Germany.'}, {'ForeName': 'Inga', 'Initials': 'I', 'LastName': 'Bekes', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Ulm, Ulm, Germany.'}, {'ForeName': 'Sibylle', 'Initials': 'S', 'LastName': 'Loibl', 'Affiliation': 'German Breast Group, Neu-Isenburg, Germany.'}, {'ForeName': 'Toralf', 'Initials': 'T', 'LastName': 'Reimer', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Rostock, Rostock, Germany. Electronic address: toralf.reimer@med.uni-rostock.de.'}]","International journal of radiation oncology, biology, physics",['10.1016/j.ijrobp.2020.04.042'] 1579,31430183,"Randomized, back-to-back trial of a new generation NBI with a high-definition white light (HQ290) for detecting colorectal polyps.","Background : The benefits of narrow band imaging (NBI) for improving the detection rate of colorectal polyps remain unclear. New generation NBI using the 290 system (290-NBI) provides an at least two-fold brighter image than that of the previous version. We aimed to compare polyp miss rates between 290-NBI colonoscopy and high-definition white light endoscopy (HDWL). Methods : In total, 117 patients were randomized to undergo either 290-NBI or HDWL from June 2015 to February 2017. In the HDWL group, we performed HDWL as an initial inspection, followed by a second inspection with NBI. In the 290-NBI group, NBI was performed as the initial inspection, followed by a second inspection with HDWL. We compared polyp and adenoma detection rates and polyp miss rates (PMR) between the two groups and analyzed the factors associated with the PMR. Results : In total, 127 polyps were detected in the 117 patients. No differences in adenoma or polyp detection rates were observed between the two groups. The PMR for 290-NBI was 20.6% and that for HDWL was 33.9% ( p  = .068). However, the non-adenomatous PMR for 290-NBI was significantly lower than that of HDWL (11.5% vs. 52.2%, p  = .002). Furthermore, the miss rates of polyps on the left side of the colon, flat-type polyps, and non-adenomatous polyps were significantly lower in the 290-NBI than HDWL. Conclusions : New generation NBI may reduce PMR, especially of flat-type and non-adenomatous polyps and those on the left side of the colon. (UMIN000025505).",2019,No differences in adenoma or polyp detection rates were observed between the two groups.,"['117 patients were randomized to undergo either 290-NBI or HDWL from June 2015 to February 2017', 'In total, 127 polyps were detected in the 117 patients']","['290-NBI colonoscopy and high-definition white light endoscopy (HDWL', 'narrow band imaging (NBI', 'new generation NBI with a high-definition white light (HQ290']","['PMR for 290-NBI', 'polyp and adenoma detection rates and polyp miss rates (PMR', 'adenoma or polyp detection rates']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0032584', 'cui_str': 'Polyp (morphologic abnormality)'}, {'cui': 'C0442726', 'cui_str': 'Detected (qualifier value)'}]","[{'cui': 'C0009378', 'cui_str': 'Endoscopy of colon'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C3539107', 'cui_str': 'Definition (core metadata concept)'}, {'cui': 'C0563228', 'cui_str': 'White light (physical force)'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C3854333', 'cui_str': 'Narrowing'}, {'cui': 'C0185014', 'cui_str': 'Banding'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0079411', 'cui_str': 'Generations'}]","[{'cui': 'C0032584', 'cui_str': 'Polyp (morphologic abnormality)'}, {'cui': 'C0001430', 'cui_str': 'Adenoma'}]",117.0,0.033682,No differences in adenoma or polyp detection rates were observed between the two groups.,"[{'ForeName': 'Haewon', 'Initials': 'H', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Digestive Disease Center and Research Institute, SoonChunHyang University School of Medicine , Bucheon , Korea.'}, {'ForeName': 'Hyeon Jeong', 'Initials': 'HJ', 'LastName': 'Goong', 'Affiliation': 'Department of Internal Medicine, Digestive Disease Center and Research Institute, SoonChunHyang University School of Medicine , Bucheon , Korea.'}, {'ForeName': 'Bong Min', 'Initials': 'BM', 'LastName': 'Ko', 'Affiliation': 'Department of Internal Medicine, Digestive Disease Center and Research Institute, SoonChunHyang University School of Medicine , Bucheon , Korea.'}, {'ForeName': 'Yu Sik', 'Initials': 'YS', 'LastName': 'Myung', 'Affiliation': 'Department of Internal Medicine, Digestive Disease Center and Research Institute, SoonChunHyang University School of Medicine , Bucheon , Korea.'}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Ho Jung', 'Affiliation': 'Department of Internal Medicine, Digestive Disease Center and Research Institute, SoonChunHyang University School of Medicine , Bucheon , Korea.'}, {'ForeName': 'Seong Ran', 'Initials': 'SR', 'LastName': 'Jeon', 'Affiliation': 'Department of Internal Medicine, Digestive Disease Center and Research Institute, SoonChunHyang University School of Medicine , Bucheon , Korea.'}, {'ForeName': 'Hyun Gun', 'Initials': 'HG', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Digestive Disease Center and Research Institute, SoonChunHyang University School of Medicine , Bucheon , Korea.'}, {'ForeName': 'Moon Sung', 'Initials': 'MS', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, Digestive Disease Center and Research Institute, SoonChunHyang University School of Medicine , Bucheon , Korea.'}]",Scandinavian journal of gastroenterology,['10.1080/00365521.2019.1650953'] 1580,31434537,Effectiveness of Lower-Extremity Functional Training (LIFT) in Young Children With Unilateral Spastic Cerebral Palsy: A Randomized Controlled Trial.,"Background . Children with unilateral spastic cerebral palsy (USCP) have strength, coordination, and balance deficits affecting gross motor skills, such as walking, running, and jumping. However, there is a paucity of evidence for effective treatments for lower-extremity (LE) function in children with USCP. Objective . To determine the effectiveness of LE intensive functional training (LIFT) compared with an attention control group receiving upper-extremity bimanual training (Hand-Arm Bimanual Intensive Therapy [H-HABIT]). Methods . A total of 24 children with USCP were randomized to receive 90 hours of LIFT (5.8 [2.3] years) or an equivalent dosage of H-HABIT (5.1 [2.6] years) delivered 2 h/d, 5 d/wk for 9 weeks. Caregivers were trained to administer the intervention in the home setting. Progress and skill progression were monitored, and supervision was provided via weekly telerehabilitation. The primary outcome was the 1-minute walk test (1MWT). Secondary outcomes included self-selected and fast walking speeds, ABILOCO-kids, 30-s chair rise test, and single-leg stance. Results . LIFT showed greater improvement for the 1MWT ( P = .017) and ABILOCO-kids ( P = .008) compared with controls. The other secondary outcomes were not different between groups. Conclusions . The administration of LE intensive interventions in the home setting by caregivers was shown to be an effective and novel mode of delivery for improving gait capacity and performance. LIFT delivered in the home setting using telerehabilitation for monitoring resulted in improvements in ambulation distance and overall walking ability as compared to an intervention of equal intensity and duration that also controlled for the increased social interaction and attention between caregiver and child.",2019,LIFT showed greater improvement for the 1MWT ( P = .017) and ABILOCO-kids ( P = .008) compared with controls.,"['Young Children With Unilateral Spastic Cerebral Palsy', 'Children with unilateral spastic cerebral palsy (USCP', 'children with USCP', '24 children with USCP']","['attention control group receiving upper-extremity bimanual training (Hand-Arm Bimanual Intensive Therapy [H-HABIT', 'LE intensive functional training (LIFT', 'Lower-Extremity Functional Training (LIFT', 'LE intensive interventions']","['ambulation distance and overall walking ability', '1-minute walk test (1MWT', 'self-selected and fast walking speeds, ABILOCO-kids, 30-s chair rise test, and single-leg stance', '1MWT']","[{'cui': 'C0337547', 'cui_str': 'Younger child (person)'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C0338596', 'cui_str': 'Spastic cerebral palsy (disorder)'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0018464', 'cui_str': 'Habits'}, {'cui': 'C0181620', 'cui_str': 'Lift'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}]","[{'cui': 'C0945826', 'cui_str': 'Ambulation'}, {'cui': 'C0012751', 'cui_str': 'Distance (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0559964', 'cui_str': 'Ambulation ability'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0179847', 'cui_str': 'Chair (physical object)'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}]",,0.11282,LIFT showed greater improvement for the 1MWT ( P = .017) and ABILOCO-kids ( P = .008) compared with controls.,"[{'ForeName': 'Bhavini K', 'Initials': 'BK', 'LastName': 'Surana', 'Affiliation': 'Department of Biobehavioral Sciences, Teachers College, Columbia University, New York, NY, USA.'}, {'ForeName': 'Claudio L', 'Initials': 'CL', 'LastName': 'Ferre', 'Affiliation': 'Burke Neurological Institute, Weill Cornell Medicine, White Plains, NY, USA.'}, {'ForeName': 'Ashley P', 'Initials': 'AP', 'LastName': 'Dew', 'Affiliation': 'Ochsner Health System, New Orleans, LA, USA.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Brandao', 'Affiliation': 'Department of Occupational Therapy and Graduate Program in Rehabilitation Sciences, Universidade Federal de Minas Gerais, Belo Horizonte, MG, Brazil.'}, {'ForeName': 'Andrew M', 'Initials': 'AM', 'LastName': 'Gordon', 'Affiliation': 'Department of Biobehavioral Sciences, Teachers College, Columbia University, New York, NY, USA.'}, {'ForeName': 'Noelle G', 'Initials': 'NG', 'LastName': 'Moreau', 'Affiliation': 'LSU Health Sciences Center, New Orleans, LA, USA.'}]",Neurorehabilitation and neural repair,['10.1177/1545968319868719'] 1581,31432432,Effects of Tai Chi on beta endorphin and inflammatory markers in older adults with chronic pain: an exploratory study.,"The purpose of this exploratory study was to examine the effects of Tai Chi on blood levels of beta endorphin (β-endorphin) and inflammatory markers in older adults with chronic pain. Forty community-dwelling older adults with chronic pain were randomized to Tai Chi or light physical exercise, and each offered twice weekly for 12 weeks. Following the 12-week intervention, neither Tai Chi nor light physical exercise changed levels of β-endorphin and inflammatory markers. However, in older adults who completed 70% or more classes, Tai Chi significantly lowered levels of β-endorphin (p < 0.05), whereas light physical exercise did not change levels of β-endorphin. The results suggest that Tai Chi may reduce levels of β-endorphin in older adults with chronic pain. Future studies are needed to better understand the role of the opioid analgesic system and immune system in regulating pain with aging and the long-term effects of Tai Chi on pain-related biomarkers.",2020,"Following the 12-week intervention, neither Tai Chi nor light physical exercise changed levels of β-endorphin and inflammatory markers.","['Forty community-dwelling older adults with chronic pain', 'older adults with chronic pain']","['Tai Chi nor light physical exercise', 'Tai Chi', 'Tai Chi or light physical exercise']","['levels of β-endorphin', 'light physical exercise', 'beta endorphin and inflammatory markers', 'β-endorphin and inflammatory markers', 'blood levels of beta endorphin (β-endorphin) and inflammatory markers']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain (finding)'}]","[{'cui': 'C0376403', 'cui_str': 'Taiji'}, {'cui': 'C0332264', 'cui_str': 'Light (weight) (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0014242', 'cui_str': 'Endorphins'}, {'cui': 'C0332264', 'cui_str': 'Light (weight) (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0005210', 'cui_str': 'beta-Endorphin (1-31)'}, {'cui': 'C0005768'}]",40.0,0.0485784,"Following the 12-week intervention, neither Tai Chi nor light physical exercise changed levels of β-endorphin and inflammatory markers.","[{'ForeName': 'Tongjian', 'Initials': 'T', 'LastName': 'You', 'Affiliation': 'Department of Exercise and Health Sciences, College of Nursing and Health Sciences, University of Massachusetts Boston, Boston, MA, 02125, USA. tongjian.you@umb.edu.'}, {'ForeName': 'Elisa F', 'Initials': 'EF', 'LastName': 'Ogawa', 'Affiliation': 'Department of Exercise and Health Sciences, College of Nursing and Health Sciences, University of Massachusetts Boston, Boston, MA, 02125, USA.'}, {'ForeName': 'Saurja', 'Initials': 'S', 'LastName': 'Thapa', 'Affiliation': 'Department of Nursing, College of Nursing and Health Sciences, University of Massachusetts Boston, Boston, MA, 02125, USA.'}, {'ForeName': 'Yurun', 'Initials': 'Y', 'LastName': 'Cai', 'Affiliation': 'Department of Nursing, College of Nursing and Health Sciences, University of Massachusetts Boston, Boston, MA, 02125, USA.'}, {'ForeName': 'Gloria Y', 'Initials': 'GY', 'LastName': 'Yeh', 'Affiliation': 'Department of Medicine, Beth Israel Deaconess Medical Center, Boston, MA, 02215, USA.'}, {'ForeName': 'Peter M', 'Initials': 'PM', 'LastName': 'Wayne', 'Affiliation': 'Harvard Medical School, Boston, MA, 02115, USA.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Shi', 'Affiliation': 'Department of Nursing, College of Nursing and Health Sciences, University of Massachusetts Boston, Boston, MA, 02125, USA.'}, {'ForeName': 'Suzanne G', 'Initials': 'SG', 'LastName': 'Leveille', 'Affiliation': 'Department of Nursing, College of Nursing and Health Sciences, University of Massachusetts Boston, Boston, MA, 02125, USA.'}]",Aging clinical and experimental research,['10.1007/s40520-019-01316-1'] 1582,31314073,"Urine Tenofovir Concentrations Correlate With Plasma and Relate to Tenofovir Disoproxil Fumarate Adherence: A Randomized, Directly Observed Pharmacokinetic Trial (TARGET Study).","BACKGROUND Direct measurement of tenofovir (TFV) in urine could be an objective measure to monitor adherence to preexposure prophylaxis (PrEP) or TFV-based antiretroviral therapy (ART). METHODS We conducted a 3-arm randomized, pharmacokinetic study of tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg among adults living with human immunodeficiency virus. Participants were randomized to receive controlled TDF/FTC dosing as (1) ""perfect"" adherence (daily); (2) ""moderate"" adherence (4 doses/week); or (3) ""low"" adherence (2 doses/week). We obtained trough spot urine and plasma samples during a 6-week directly observed therapy period and a 4-week washout period. TFV concentrations were compared between adherence arms using 1-way analysis of variance. RESULTS Among 28 participants, the median age was 33 years and 16 (57%) were male. Correlation between TFV plasma and urine concentrations was strong (ρ = 0.78; P < .0001). Median (interquartile range) steady-state trough TFV concentrations (ng/mL) for perfect, moderate, and low TDF adherence were 41 (26-52), 16 (14-19), and 4 (3-5) in plasma; and 6480 (3940-14 300), 3405 (2210-5020), and 448 (228-675) in urine. Trough TFV concentrations at steady state were significantly different between the 3 adherence arms for plasma (P < .0001) and urine (P = .0002). Following drug cessation, TFV concentrations persisted longer in urine than plasma samples. Washout urine TFV concentrations and time to undetectable concentrations did not differ between the 3 randomized adherence groups. CONCLUSIONS Urine TFV concentrations can inform interpretation of novel point-of-care urine-based TFV assays to assess recent TDF adherence. CLINICAL TRIALS REGISTRATION NCT0301260.",2020,Trough TFV concentrations at steady state were significantly different between the three adherence arms for plasma (p<0.0001) and urine (p=0.0002).,"['HIV-uninfected adults', '28 participants, mean age was 33 years and 16 (57%) were male', 'adults with controlled levels of adherence to advance development and enable interpretation of point-of-care urine assays']","['controlled TDF/FTC', 'tenofovir (TFV', 'tenofovir disoproxil fumarate (TDF) 300mg/emtricitabine (FTC']","['Washout urine TFV concentrations and time-to-undetectable concentrations', 'Median [IQR] steady-state trough TFV concentrations (ng/mL) for perfect, moderate, and low TDF adherence in plasma', 'TDF Adherence', 'urine TFV concentrations', 'Trough TFV concentrations', 'TFV plasma and urine concentrations', 'TFV concentrations']","[{'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0619283', 'cui_str': 'IS 33'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C0562342', 'cui_str': 'Empowered (finding)'}, {'cui': 'C0459471', 'cui_str': 'Interpretation (attribute)'}, {'cui': 'C0282664', 'cui_str': 'Point-of-Care'}, {'cui': 'C0042037'}, {'cui': 'C1510438', 'cui_str': 'Assay technique (qualifier value)'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0384228', 'cui_str': 'Tenofovir'}, {'cui': 'C1099776', 'cui_str': 'Tenofovir disoproxil fumarate'}, {'cui': 'C0909839', 'cui_str': 'emtricitabine'}]","[{'cui': 'C0042037'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0205361', 'cui_str': 'Steady (qualifier value)'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0444506', 'cui_str': 'Trough (qualifier value)'}, {'cui': 'C0439275', 'cui_str': 'ug/L'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}]",28.0,0.15944,Trough TFV concentrations at steady state were significantly different between the three adherence arms for plasma (p<0.0001) and urine (p=0.0002).,"[{'ForeName': 'Paul K', 'Initials': 'PK', 'LastName': 'Drain', 'Affiliation': 'Department of Global Health, University of Washington, Seattle.'}, {'ForeName': 'Rachel W', 'Initials': 'RW', 'LastName': 'Kubiak', 'Affiliation': 'Department of Epidemiology, University of Washington, Seattle.'}, {'ForeName': 'Oraphan', 'Initials': 'O', 'LastName': 'Siriprakaisil', 'Affiliation': 'Sanpatong Hospital, Chiang Mai, Thailand.'}, {'ForeName': 'Virat', 'Initials': 'V', 'LastName': 'Klinbuayaem', 'Affiliation': 'Sanpatong Hospital, Chiang Mai, Thailand.'}, {'ForeName': 'Justice', 'Initials': 'J', 'LastName': 'Quame-Amaglo', 'Affiliation': 'Department of Global Health, University of Washington, Seattle.'}, {'ForeName': 'Pra-Ornsuda', 'Initials': 'PO', 'LastName': 'Sukrakanchana', 'Affiliation': 'Program for HIV Prevention and Treatment (PHPT) lab at Chiang Mai University/IRD UMI 174, Thailand.'}, {'ForeName': 'Suriyan', 'Initials': 'S', 'LastName': 'Tanasri', 'Affiliation': 'Program for HIV Prevention and Treatment (PHPT) lab at Chiang Mai University/IRD UMI 174, Thailand.'}, {'ForeName': 'Pimpinun', 'Initials': 'P', 'LastName': 'Punyati', 'Affiliation': 'Program for HIV Prevention and Treatment (PHPT) lab at Chiang Mai University/IRD UMI 174, Thailand.'}, {'ForeName': 'Wasna', 'Initials': 'W', 'LastName': 'Sirirungsi', 'Affiliation': 'Department of Medical Technology, Faculty of Associated Medical Sciences, Chiang Mai University, Thailand.'}, {'ForeName': 'Ratchada', 'Initials': 'R', 'LastName': 'Cressey', 'Affiliation': 'Department of Medical Technology, Faculty of Associated Medical Sciences, Chiang Mai University, Thailand.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Bacchetti', 'Affiliation': 'University of California, San Francisco, Boston, Massachusetts.'}, {'ForeName': 'Hideaki', 'Initials': 'H', 'LastName': 'Okochi', 'Affiliation': 'University of California, San Francisco, Boston, Massachusetts.'}, {'ForeName': 'Jared M', 'Initials': 'JM', 'LastName': 'Baeten', 'Affiliation': 'Department of Global Health, University of Washington, Seattle.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Gandhi', 'Affiliation': 'University of California, San Francisco, Boston, Massachusetts.'}, {'ForeName': 'Tim R', 'Initials': 'TR', 'LastName': 'Cressey', 'Affiliation': 'Program for HIV Prevention and Treatment (PHPT) lab at Chiang Mai University/IRD UMI 174, Thailand.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciz645'] 1583,32495306,Development of an Intervention to Promote Physical Activity and Reduce Dietary Sodium Intake for Preventing Hypertension and Chronic Disease in Filipino Americans.,"Hypertension is a common chronic health condition affecting Filipino Americans. This pilot study examined the feasibility of addressing high rates of hypertension among Filipino Americans through the implementation of a culturally tailored education intervention. Filipino Americans living in the Greater Philadelphia Area were recruited through community-based organizations for participation and were engaged using a community-based participatory research (CBPR) framework. The study included pre- and post-intervention blood pressure measurements, self-reported body mass index, and questionnaires about physical activity and salt intake. The intervention to promote physical activity and reduce salt intake was conducted through two educational sessions and was accompanied by follow-up at 3 months and by the collection of urine samples for 24-h urinary sodium intake biomarker analysis. Following intervention, a non-statistically significant decrease in urine sodium was observed in both the intervention and the control groups. For systolic blood pressure, a reduction of 12.6 mmHg and an increase in 5.3 mmHg was observed in the intervention and control groups, respectively. Diastolic pressure decreased 3.8 mmHg for the intervention group and increased 5.6 mmHg among controls. The culturally tailored education intervention reported here represents a promising tool for blood pressure reduction in high-risk ethnic populations. The methods used were effective for the recruitment and retention of ethnic minorities in a community-based setting.",2020,"Following intervention, a non-statistically significant decrease in urine sodium was observed in both the intervention and the control groups.","['Filipino Americans', 'Filipino Americans living in the Greater Philadelphia Area were recruited through community-based organizations for participation and were engaged using a community-based participatory research (CBPR) framework']","['Intervention to Promote Physical Activity and Reduce Dietary Sodium Intake', 'culturally tailored education intervention']","['Diastolic pressure', 'pre- and post-intervention blood pressure measurements, self-reported body mass index, and questionnaires about physical activity and salt intake', 'systolic blood pressure', 'urine sodium']","[{'cui': 'C0597918', 'cui_str': 'Filipino Americans'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0031525', 'cui_str': 'Philadelphia'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0029237', 'cui_str': 'Organization'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C2350575', 'cui_str': 'Community-Based Participatory Research'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0425433', 'cui_str': 'Dietary sodium intake'}, {'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0005824', 'cui_str': 'Blood pressure taking'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0036140', 'cui_str': 'Salts'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C1256585', 'cui_str': 'Sodium measurement, urine'}]",,0.0143801,"Following intervention, a non-statistically significant decrease in urine sodium was observed in both the intervention and the control groups.","[{'ForeName': 'Grace X', 'Initials': 'GX', 'LastName': 'Ma', 'Affiliation': 'Center for Asian Health, Lewis Katz School of Medicine, Temple University, 3440 N Broad St., Suite 320, Kresge East Bldg, Philadelphia, PA, 19140, USA. grace.ma@temple.edu.'}, {'ForeName': 'Aisha', 'Initials': 'A', 'LastName': 'Bhimla', 'Affiliation': 'Center for Asian Health, Lewis Katz School of Medicine, Temple University, 3440 N Broad St., Suite 320, Kresge East Bldg, Philadelphia, PA, 19140, USA.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Zhu', 'Affiliation': 'Center for Asian Health, Lewis Katz School of Medicine, Temple University, 3440 N Broad St., Suite 320, Kresge East Bldg, Philadelphia, PA, 19140, USA.'}, {'ForeName': 'Maayan', 'Initials': 'M', 'LastName': 'Beeber', 'Affiliation': 'Hunter College, The City University of New York (CUNY), New York, NY, USA.'}, {'ForeName': 'Ferdinand', 'Initials': 'F', 'LastName': 'Aczon', 'Affiliation': 'Filipino American Society of South Jersey Inc., Mount Laurel, NJ, 08084, USA.'}, {'ForeName': 'Yin', 'Initials': 'Y', 'LastName': 'Tan', 'Affiliation': 'Center for Asian Health, Lewis Katz School of Medicine, Temple University, 3440 N Broad St., Suite 320, Kresge East Bldg, Philadelphia, PA, 19140, USA.'}, {'ForeName': 'Sally Boyle', 'Initials': 'SB', 'LastName': 'Quinn', 'Affiliation': 'Division of Nephrology, Temple University School of Medicine, Philadelphia, PA, 19140, USA.'}, {'ForeName': 'Omar', 'Initials': 'O', 'LastName': 'Khan', 'Affiliation': 'Center for Asian Health, Lewis Katz School of Medicine, Temple University, 3440 N Broad St., Suite 320, Kresge East Bldg, Philadelphia, PA, 19140, USA.'}, {'ForeName': 'Crystal A', 'Initials': 'CA', 'LastName': 'Gadegbeku', 'Affiliation': 'Division of Nephrology, Temple University School of Medicine, Philadelphia, PA, 19140, USA.'}]",Journal of racial and ethnic health disparities,['10.1007/s40615-020-00781-z'] 1584,32495381,Randomized controlled trial of multi-modular motion-assisted memory desensitization and reconsolidation (3MDR) for male military veterans with treatment-resistant post-traumatic stress disorder.,"OBJECTIVE To explore the potential efficacy of multi-modular motion-assisted memory desensitization and reprocessing (3MDR) in British military veterans with treatment-resistant service-related PTSD. METHODS Exploratory single-blind, randomized, parallel arm, cross-over controlled trial with nested process evaluation to assess fidelity, adherence and factors that influence outcome. RESULTS A total of 42 participants (all male) were randomized with 83% retention at 12 weeks and 86% at 26 weeks. The difference in mean Clinician-Administered PTSD Scale for DSM-5 scores between the immediate and delayed 3MDR arms was -9.38 (95% CI -17.33 to -1.44, P = 0.021) at 12 weeks and -3.59 (-14.39 to 7.20, P = 0.513) at 26 weeks when both groups had received 3MDR. The likely effect size of 3MDR was found to be 0.65. Improvements were maintained at 26-week follow-up. 3MDR was found to be acceptable to most, but not all, participants. Several factors that may impact efficacy and acceptability of 3MDR were identified. CONCLUSION 3MDR is a promising new intervention for treatment-resistant PTSD with emerging evidence of effect.",2020,"(-14.39 to 7.20, p= 0.513) at 26 weeks when both groups had received 3MDR.","['male military veterans with treatment-resistant post-traumatic stress disorder', 'British military veterans with treatment-resistant, service-related PTSD', '42 participants (all male']","['multi-modular motion-assisted memory desensitisation and reconsolidation (3MDR', 'multi-modular motion-assisted memory desensitisation and reprocessing (3MDR', '3MDR']","['3MDR', 'mean Clinician Administered PTSD Scale for DSM-5 scores']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0026126', 'cui_str': 'Military personnel'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0557854', 'cui_str': 'Services'}]","[{'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0026597', 'cui_str': 'Motion'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1137105', 'cui_str': 'DSM-V'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.133104,"(-14.39 to 7.20, p= 0.513) at 26 weeks when both groups had received 3MDR.","[{'ForeName': 'J I', 'Initials': 'JI', 'LastName': 'Bisson', 'Affiliation': 'School of Medicine, Cardiff University, Cardiff, UK.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'van Deursen', 'Affiliation': 'School of Healthcare Sciences, Cardiff University, Cardiff, UK.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Hannigan', 'Affiliation': 'School of Healthcare Sciences, Cardiff University, Cardiff, UK.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Kitchiner', 'Affiliation': ""Veterans' NHS Wales, Cardiff and Vale University Health Board, Cardiff, UK.""}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Barawi', 'Affiliation': 'School of Medicine, Cardiff University, Cardiff, UK.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Jones', 'Affiliation': 'School of Healthcare Sciences, Cardiff University, Cardiff, UK.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Pickles', 'Affiliation': 'Centre for Trials Research, Cardiff University, Cardiff, UK.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Skipper', 'Affiliation': 'School of Medicine, Cardiff University, Cardiff, UK.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Young', 'Affiliation': 'Cardiff and Vale University Health Board, Cardiff, UK.'}, {'ForeName': 'L R', 'Initials': 'LR', 'LastName': 'Abbott', 'Affiliation': 'School of Healthcare Sciences, Cardiff University, Cardiff, UK.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'van Gelderen', 'Affiliation': 'Department of Psychiatry, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'M J', 'Initials': 'MJ', 'LastName': 'Nijdam', 'Affiliation': ""ARQ Centrum'45, ARQ National Psychotrauma Centre, Diemen, The Netherlands.""}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Vermetten', 'Affiliation': 'Department of Psychiatry, Leiden University Medical Center, Leiden, The Netherlands.'}]",Acta psychiatrica Scandinavica,['10.1111/acps.13200'] 1585,31337400,Influences of the biofeedback content on robotic post-stroke gait rehabilitation: electromyographic vs joint torque biofeedback.,"BACKGROUND Add-on robot-mediated therapy has proven to be more effective than conventional therapy alone in post-stroke gait rehabilitation. Such robot-mediated interventions routinely use also visual biofeedback tools. A better understanding of biofeedback content effects when used for robotic locomotor training may improve the rehabilitation process and outcomes. METHODS This randomized cross-over pilot trial aimed to address the possible impact of different biofeedback contents on patients' performance and experience during Lokomat training, by comparing a novel biofeedback based on online biological electromyographic information (EMGb) versus the commercial joint torque biofeedback (Rb) in sub-acute non ambulatory patients. 12 patients were randomized into two treatment groups, A and B, based on two different biofeedback training. For both groups, study protocol consisted of 12 Lokomat sessions, 6 for each biofeedback condition, 40 min each, 3 sessions per week of frequency. All patients performed Lokomat trainings as an add-on therapy to the conventional one that was the same for both groups and consisted of 40 min per day, 5 days per week. The primary outcome was the Modified Ashworth Spasticity Scale, and secondary outcomes included clinical, neurological, mechanical, and personal experience variables collected before and after each biofeedback training. RESULTS Lokomat training significantly improved gait/daily living activity independence and trunk control, nevertheless, different effects due to biofeedback content were remarked. EMGb was more effective to reduce spasticity and improve muscle force at the ankle, knee and hip joints. Robot data suggest that Rb induces more adaptation to robotic movements than EMGb. Furthermore, Rb was perceived less demanding than EMGb, even though patient motivation was higher for EMGb. Robot was perceived to be effective, easy to use, reliable and safe: acceptability was rated as very high by all patients. CONCLUSIONS Specific effects can be related to biofeedback content: when muscular-based information is used, a more direct effect on lower limb spasticity and muscle activity is evidenced. In a similar manner, when biofeedback treatment is based on joint torque data, a higher patient compliance effect in terms of force exerted is achieved. Subjects who underwent EMGb seemed to be more motivated than those treated with Rb.",2019,"Robot was perceived to be effective, easy to use, reliable and safe: acceptability was rated as very high by all patients. ","['robotic post-stroke gait rehabilitation', 'sub-acute non ambulatory patients', ""patients' performance and experience during Lokomat training"", '12 patients']","['electromyographic vs joint torque biofeedback', 'robotic locomotor training', 'novel biofeedback based on online biological electromyographic information (EMGb) versus the commercial joint torque biofeedback (Rb', 'biofeedback training', 'EMGb']","['spasticity and improve muscle force', 'effective, easy to use, reliable and safe: acceptability', 'gait/daily living activity independence and trunk control', 'Modified Ashworth Spasticity Scale, and secondary outcomes included clinical, neurological, mechanical, and personal experience variables']","[{'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C1264637', 'cui_str': 'Substance amount'}, {'cui': 'C0439841', 'cui_str': 'Ambulatory'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0022417', 'cui_str': 'Joints'}, {'cui': 'C0376590', 'cui_str': 'Torque'}, {'cui': 'C0678663', 'cui_str': 'Biofeedback, function (observable entity)'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0419113', 'cui_str': 'Locomotor training (regime/therapy)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C4553887', 'cui_str': 'Biologic Drugs'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0026838', 'cui_str': 'Muscle Spasticity'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0443221', 'cui_str': 'Forced (qualifier value)'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C0332219', 'cui_str': 'Easy (qualifier value)'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0001288', 'cui_str': 'ADL'}, {'cui': 'C0426971', 'cui_str': 'Trunk control (observable entity)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205494', 'cui_str': 'Neurologic (qualifier value)'}, {'cui': 'C0443254', 'cui_str': 'Mechanical (qualifier value)'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}]",,0.0331252,"Robot was perceived to be effective, easy to use, reliable and safe: acceptability was rated as very high by all patients. ","[{'ForeName': 'Federica', 'Initials': 'F', 'LastName': 'Tamburella', 'Affiliation': 'Spinal Rehabilitation Laboratory - Neurological and Spinal Cord Injury Rehabilitation Department A, Santa Lucia Foundation IRCCS, Via Ardeatina 306 -, 00179, Rome, Italy. f.tamburella@hsantalucia.it.'}, {'ForeName': 'Juan C', 'Initials': 'JC', 'LastName': 'Moreno', 'Affiliation': 'Spanish National Research Council, Cajal Institute, Neural Rehabilitation Group, Av. Doctor Arce, 37, 28002, Madrid, Spain.'}, {'ForeName': 'Diana Sofía', 'Initials': 'DS', 'LastName': 'Herrera Valenzuela', 'Affiliation': 'Department of Biomedical Engineering, Universidad de los Andes, Bogotá, Colombia.'}, {'ForeName': 'Iolanda', 'Initials': 'I', 'LastName': 'Pisotta', 'Affiliation': 'Laboratory of Robotics Applied to Neurological Rehabilitation- NeuroRobot - Neurological and Spinal Cord Injury Rehabilitation Department A, Santa Lucia Foundation IRCCS, Via Ardeatina 306 -, 00179, Rome, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Iosa', 'Affiliation': 'Laboratory for the Study of Mind and Action in Rehabilitation Technologies - Smart Lab, Santa Lucia Foundation IRCCS, Via Ardeatina 306, 00179, Rome, Italy.'}, {'ForeName': 'Febo', 'Initials': 'F', 'LastName': 'Cincotti', 'Affiliation': 'Department of Computer, Control and Management Engineering, Sapienza University of Rome, Rome, Italy.'}, {'ForeName': 'Donatella', 'Initials': 'D', 'LastName': 'Mattia', 'Affiliation': 'Neuroelectrical Imaging and BCI Lab, IRCCS S. Lucia Foundation, Via Ardeatina 306 -, 00179, Rome, Italy.'}, {'ForeName': 'José L', 'Initials': 'JL', 'LastName': 'Pons', 'Affiliation': 'Spanish National Research Council, Cajal Institute, Neural Rehabilitation Group, Av. Doctor Arce, 37, 28002, Madrid, Spain.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Molinari', 'Affiliation': 'Spinal Rehabilitation Laboratory - Neurological and Spinal Cord Injury Rehabilitation Department A, Santa Lucia Foundation IRCCS, Via Ardeatina 306 -, 00179, Rome, Italy.'}]",Journal of neuroengineering and rehabilitation,['10.1186/s12984-019-0558-0'] 1586,30098860,Comparison of DEXA and Bioimpedance for Body Composition Measurements in Nondialysis Patients With CKD.,"OBJECTIVES The aims of this study are (1) to compare dual-energy X-ray absorptiometry (DEXA) and bioimpedance for body composition measurements in nondialysis patients with chronic kidney disease, and (2) to investigate factors associated with any measurement differences. DESIGN AND METHODS This is a substudy using some baseline data from a randomized controlled clinical trial. One hundred twenty patients (aged 65 ± 14 years) with a measured glomerular filtration rate 8 to 55 mL/min/1.73m 2 , not on renal replacement therapy, irrespective of age and number of comorbidities, were included from 2011 to 2016. For DEXA measurements, Lunar Prodigy or Lunar iDXA were used. For bioimpedance measurements, body composition monitor (BCM) was used. Glomerular filtration rate was measured with iohexol clearance. Data were analyzed using R software. Bland-Altman analysis was performed to compare the 2 measurements. The measurement difference was DEXA minus BCM. Multiple linear regression analysis was performed to analyze relationships between variables. RESULTS The estimation of fat-free mass was higher using BCM than DEXA, with a mean difference of -2.8 kg and limits of agreement (mean ± 2 SD) ranging from -12 kg to 6.5 kg. The estimation of fat mass was lower using BCM than DEXA, with a mean difference of 3.1 kg and limits of agreement (mean ± 2 SD) ranging from -6.8 kg to 13 kg. The measurement differences were significantly related to lean tissue index, fat tissue index, extracellular water, intracellular water, extracellular water/intracellular water, total body water, and overhydration. CONCLUSION Our study showed a limited agreement between DEXA and bioimpedance, indicating that these 2 measurements are not interchangeable in nondialysis patients with chronic kidney disease. Lean tissue index, fat tissue index, and body water might contribute to the measurement differences, while measured glomerular filtration rate is not a factor associated with the measurement differences for body composition. Thus, we suggest that the same measure of body composition be used over time.",2019,"The measurement differences were significantly related to lean tissue index, fat tissue index, extracellular water, intracellular water, extracellular water/intracellular water, total body water, and overhydration. ","['nondialysis patients with chronic kidney disease', 'nondialysis patients with chronic kidney disease, and (2', 'Nondialysis Patients With CKD', 'One hundred twenty patients (aged 65 ± 14 years) with a measured glomerular filtration rate 8 to 55']","['dual-energy X-ray absorptiometry (DEXA) and bioimpedance', 'DEXA and Bioimpedance']","['lean tissue index, fat tissue index, extracellular water, intracellular water, extracellular water/intracellular water, total body water, and overhydration', 'estimation of fat mass', 'For DEXA measurements, Lunar Prodigy or Lunar iDXA', 'Lean tissue index, fat tissue index', 'Glomerular filtration rate', 'Body Composition Measurements']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1561643', 'cui_str': 'Chronic Kidney Diseases'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0017654', 'cui_str': 'Glomerular Filtration Rate'}]","[{'cui': 'C1510486', 'cui_str': 'Dual X-Ray Absorptiometry'}]","[{'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0521119', 'cui_str': 'Extracellular (qualifier value)'}, {'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C0178719', 'cui_str': 'Intracellular (qualifier value)'}, {'cui': 'C0429632', 'cui_str': 'Total body water (observable entity)'}, {'cui': 'C0392689', 'cui_str': 'Overhydration (disorder)'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0388929', 'cui_str': 'Prodigy'}, {'cui': 'C0017654', 'cui_str': 'Glomerular Filtration Rate'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}]",120.0,0.084384,"The measurement differences were significantly related to lean tissue index, fat tissue index, extracellular water, intracellular water, extracellular water/intracellular water, total body water, and overhydration. ","[{'ForeName': 'Yunan', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'Nephrology, Faculty of Medicine, Department of Clinical Sciences Lund, Lund University, Skåne University Hospital, Lund, Sweden.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Höglund', 'Affiliation': 'Division of Clinical Chemistry & Pharmacology, Department of Laboratory Medicine, Lund University, Skåne University Hospital, Lund, Sweden.'}, {'ForeName': 'Naomi', 'Initials': 'N', 'LastName': 'Clyne', 'Affiliation': 'Nephrology, Faculty of Medicine, Department of Clinical Sciences Lund, Lund University, Skåne University Hospital, Lund, Sweden. Electronic address: naomi.clyne@med.lu.se.'}]",Journal of renal nutrition : the official journal of the Council on Renal Nutrition of the National Kidney Foundation,['10.1053/j.jrn.2018.05.003'] 1587,32495016,Postoperative comparison of laparoscopic radical resection and open abdominal radical hysterectomy for cervical cancer patient.,"PURPOSE There are limited data regarding postoperative complications and autoimmune reactions caused by surgery in early-stage cervical cancer patients who underwent laparoscopic radical resection (LRR). This study aimed to investigate the therapeutic effect of LRR of cervical cancer patients and its effect on cytokines. METHODS 168 patients with cervical cancer were enrolled. The patients were divided into open group and laparoscopic group according to the random number table method, with 84 cases in each group. The surgical-related indexes and the incidence of complications of the two groups were observed, and the IFN-γ, TNF, and IL-1/2/4/6/8/10/12 levels in peripheral blood were compared before and after surgery in both groups. RESULTS The operation time of the patients in the laparoscopic group was significantly shorter than that in the open group (119.56 ± 45.26 vs. 206.36 ± 54.39, P < 0.01). The intraoperative blood loss in the laparoscopic group was significantly less than that in the open group (155.29 ± 57.58 vs. 529.58 ± 162.4, P < 0.01). The postoperative visual analog scale (VAS) score was also significantly lower than that in the open group (3.65 ± 0.88 vs. 6.32 ± 1.12, P < 0.01). There was no significant difference in the incidence of complications between the two groups. The degree of inflammatory cytokines changes caused by LRR was less than that of open radical surgery (P < 0.001). CONCLUSIONS LRR surgery has less stress on patients with early cervical cancer than open surgery within 5 days after surgery, which has certain reference value for early cervical cancer treatment.",2020,"The degree of inflammatory cytokines changes caused by LRR was less than that of open radical surgery (P < 0.001). ","['168 patients with cervical cancer were enrolled', 'early-stage cervical cancer patients who underwent', 'cervical cancer patient', 'cervical cancer patients', 'patients with early cervical cancer']","['laparoscopic radical resection and open abdominal radical hysterectomy', 'laparoscopic', 'laparoscopic radical resection (LRR', 'LRR surgery']","['IFN-γ, TNF, and IL-1/2/4/6/8/10/12 levels in peripheral blood', 'degree of inflammatory cytokines changes', 'postoperative visual analog scale (VAS) score', 'intraoperative blood loss', 'incidence of complications', 'operation time']","[{'cui': 'C4319556', 'cui_str': '168'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C1279919', 'cui_str': 'Early'}]","[{'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0302912', 'cui_str': 'Radical'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C2987682', 'cui_str': 'Radical hysterectomy'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",168.0,0.0199014,"The degree of inflammatory cytokines changes caused by LRR was less than that of open radical surgery (P < 0.001). ","[{'ForeName': 'Qin', 'Initials': 'Q', 'LastName': 'Xu', 'Affiliation': ""Department of Obstetrics and Gynaecology, The First People's Hospital of Yunnan Province, No. 157 Jinbi Road, Kunming, 650032, Yunnan, China.""}, {'ForeName': 'Mingfeng', 'Initials': 'M', 'LastName': 'Dong', 'Affiliation': ""Department of Obstetrics and Gynaecology, The First People's Hospital of Yunnan Province, No. 157 Jinbi Road, Kunming, 650032, Yunnan, China.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Dong', 'Affiliation': ""Department of Obstetrics and Gynaecology, The First People's Hospital of Yunnan Province, No. 157 Jinbi Road, Kunming, 650032, Yunnan, China.""}, {'ForeName': 'Dehong', 'Initials': 'D', 'LastName': 'Yang', 'Affiliation': ""Department of Obstetrics and Gynaecology, The First People's Hospital of Yunnan Province, No. 157 Jinbi Road, Kunming, 650032, Yunnan, China.""}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': ""Department of Obstetrics and Gynaecology, The First People's Hospital of Yunnan Province, No. 157 Jinbi Road, Kunming, 650032, Yunnan, China.""}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': ""Department of Obstetrics and Gynaecology, The First People's Hospital of Yunnan Province, No. 157 Jinbi Road, Kunming, 650032, Yunnan, China.""}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Ren', 'Affiliation': ""Department of Obstetrics and Gynaecology, The First People's Hospital of Yunnan Province, No. 157 Jinbi Road, Kunming, 650032, Yunnan, China. yinianwuji212@163.com.""}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Feng', 'Affiliation': ""Department of Obstetrics and Gynaecology, The First People's Hospital of Yunnan Province, No. 157 Jinbi Road, Kunming, 650032, Yunnan, China. hcfy98@126.com.""}]",Archives of gynecology and obstetrics,['10.1007/s00404-020-05606-2'] 1588,31423922,"Optimal delay time to initiate anticoagulation after ischemic stroke in atrial fibrillation (START): Methodology of a pragmatic, response-adaptive, prospective randomized clinical trial.","RATIONALE An estimated 15% of all strokes are associated with untreated atrial fibrillation. Long-term secondary stroke prevention in atrial fibrillation is anticoagulation, increasingly with non-vitamin K oral anticoagulants. The optimal time to initiate anticoagulation following an atrial fibrillation-related stroke that balances hemorrhagic conversion with recurrent stroke is not yet known. AIMS To determine if there is an optimal delay time to initiate anticoagulation after atrial fibrillation-related stroke that optimizes the composite outcome of hemorrhagic conversion and recurrent ischemic stroke. SAMPLE SIZE ESTIMATES The study will enroll 1500 total subjects split between a mild to moderate stroke cohort (1000) and a severe stroke cohort (500). METHODS AND DESIGN This study is a multi-center, prospective, randomized, pragmatic, adaptive trial that randomizes subjects to four arms of time to start of anticoagulation. The four arms for mild to moderate stroke are: Day 3, Day 6, Day 10, and Day 14. The time intervals for severe stroke are: Day 6, Day 10, Day 14, and Day 21. Allocation involves a response adaptive randomization via interim analyses to favor the arms that have a better risk-benefit profile. STUDY OUTCOMES The primary outcome event is the composite occurrence of an ischemic or hemorrhagic event within 30 days of the index stroke. Secondary outcomes are also collected at 30 and 90 days. DISCUSSION The optimal timing of direct oral anticoagulants post-ischemic stroke requires prospective randomized testing. A pragmatically designed trial with adaptive allocation and randomization to multiple time intervals such as the START trial is best suited to answer this question in order to directly inform current practice on this question.",2019,"To determine if there is an optimal delay time to initiate anticoagulation after atrial fibrillation-related stroke that optimizes the composite outcome of hemorrhagic conversion and recurrent ischemic stroke. ",['1500 total subjects split between a mild to moderate stroke cohort (1000) and a severe stroke cohort (500'],[],['composite occurrence of an ischemic or hemorrhagic event within 30 days of the index stroke'],"[{'cui': 'C4517582', 'cui_str': '1500'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C3816747', 'cui_str': 'Five hundred'}]",[],"[{'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0475224', 'cui_str': 'Ischemic (qualifier value)'}, {'cui': 'C0333275', 'cui_str': 'Hemorrhagic (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}]",,0.18034,"To determine if there is an optimal delay time to initiate anticoagulation after atrial fibrillation-related stroke that optimizes the composite outcome of hemorrhagic conversion and recurrent ischemic stroke. ","[{'ForeName': 'Benjamin T', 'Initials': 'BT', 'LastName': 'King', 'Affiliation': 'Department of Neurology, University of Texas Dell Medical School, Austin, TX, USA.'}, {'ForeName': 'Patrick D', 'Initials': 'PD', 'LastName': 'Lawrence', 'Affiliation': 'Department of Neurology, University of Texas Dell Medical School, Austin, TX, USA.'}, {'ForeName': 'Truman J', 'Initials': 'TJ', 'LastName': 'Milling', 'Affiliation': 'Department of Neurology, University of Texas Dell Medical School, Austin, TX, USA.'}, {'ForeName': 'Steven J', 'Initials': 'SJ', 'LastName': 'Warach', 'Affiliation': 'Department of Neurology, University of Texas Dell Medical School, Austin, TX, USA.'}]",International journal of stroke : official journal of the International Stroke Society,['10.1177/1747493019870651'] 1589,31416769,"Riociguat for idiopathic interstitial pneumonia-associated pulmonary hypertension (RISE-IIP): a randomised, placebo-controlled phase 2b study.","BACKGROUND Idiopathic interstitial pneumonias are often complicated by pulmonary hypertension, increasing morbidity and mortality. There are no approved treatments for pulmonary hypertension associated with idiopathic interstitial pneumonia (PH-IIP). We aimed to evaluate the efficacy and safety of riociguat in patients with PH-IIP. METHODS RISE-IIP was a double-blind, randomised, placebo-controlled study done at 65 pulmonary hypertension and interstitial lung disease centres in 19 countries to evaluate the efficacy and safety of riociguat in patients with PH-IIP. Eligible patients were adults (aged 18-80 years) diagnosed with idiopathic interstitial pneumonia (as per American Thoracic Society/European Respiratory Society/Japanese Respiratory Society/Latin American Thoracic Association guidelines), forced vital capacity (FVC) of at least 45%, 6MWD of 150-450 m, WHO functional classes II-IV, precapillary pulmonary hypertension confirmed by right heart catheterisation, systolic blood pressure of at least 95 mm Hg, and no signs or symptoms of hypotension. Patients were randomly allocated (1:1) using an interactive voice and web response system to riociguat (0·5-2·5 mg three times daily) or placebo for 26 weeks (main study), after which they could enter an open-label extension in which all patients received riociguat. The primary endpoint was change in 6-min walking distance (6MWD) in the intention-to-treat population. Prespecified safety variables included adverse events and serious adverse events, laboratory parameters, and adverse events of special interest (haemoptysis and symptomatic hypotension), assessed in the intention-to-treat population. This trial is registered with ClinicalTrials.gov, number NCT02138825. FINDINGS Between June 4, 2014, and May 5, 2016, we enrolled 229 participants. After the exclusion of 82 participants, 147 were randomly allocated to treatment (73 to riociguat, 74 to placebo). The study was terminated early (median treatment duration 157 days [range 6-203]) at the request of the data monitoring committee owing to increased serious adverse events (main study: 27 [37%] of 73 participants in the riociguat group vs 17 [23%] of 74 in the placebo group) and mortality in patients receiving riociguat, and the absence of efficacy signals in the riociguat group. 11 patients died in the main study (eight in the riociguat group, three in the placebo group), and nine died in the extension phase (one in the riociguat group, eight in the former placebo group; all received riociguat). In the main study, the most common adverse events were peripheral oedema (16 [22%] of 73 in the riociguat group vs seven [9%] of 74 in the placebo group) and diarrhoea (11 [15%] vs seven [9%]). The most common serious adverse events were worsening of interstitial lung disease (main study: six [8%] of 73 in the riociguat group vs five [7%] of 74 in the placebo group) and pneumonia (four [5%] vs one [1%]). Riociguat did not improve 6MWD versus placebo at 26 weeks (least-squares mean difference 21 m; 95% CI -9 to 52). INTERPRETATION In patients with PH-IIP, riociguat was associated with increased serious adverse events and mortality, and an unfavourable risk-benefit profile. Riociguat should not be used in patients with PH-IIP. FUNDING Bayer AG and Merck & Co.",2019,"Riociguat did not improve 6MWD versus placebo at 26 weeks (least-squares mean difference 21 m; 95% CI -9 to 52). ","['Between June 4, 2014, and May 5, 2016', 'idiopathic interstitial pneumonia-associated pulmonary hypertension (RISE-IIP', 'patients with PH-IIP', 'enrolled 229 participants', '65 pulmonary hypertension and interstitial lung disease centres in 19 countries', 'Eligible patients were adults (aged 18-80 years) diagnosed with idiopathic interstitial pneumonia (as per American Thoracic Society/European Respiratory Society/Japanese Respiratory Society/Latin American Thoracic Association guidelines), forced vital capacity (FVC) of at least 45%, 6MWD of 150-450 m, WHO functional classes II-IV, precapillary pulmonary hypertension confirmed by right heart catheterisation, systolic blood pressure of at least 95 mm Hg, and no signs or symptoms of hypotension']","['placebo', 'Riociguat', 'interactive voice and web response system to riociguat (0·5-2·5 mg three times daily) or placebo', 'riociguat']","['diarrhoea', 'adverse events and serious adverse events, laboratory parameters, and adverse events of special interest (haemoptysis and symptomatic hypotension), assessed in the intention-to-treat population', 'mortality', 'serious adverse events', '6MWD', 'pneumonia', 'efficacy and safety of riociguat', 'peripheral oedema', 'serious adverse events and mortality', '6-min walking distance (6MWD']","[{'cui': 'C0085786', 'cui_str': 'Alveolitis, Fibrosing'}, {'cui': 'C1963999', 'cui_str': 'Pulmonary hypertension (SMQ)'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1869044', 'cui_str': 'Interstitial lung disease (SMQ)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0817096', 'cui_str': 'Chest'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0239307', 'cui_str': 'European (ethnic group)'}, {'cui': 'C1556094', 'cui_str': 'Japanese'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C3714541', 'cui_str': 'Forced Vital Capacity'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C3844104', 'cui_str': 'Four hundred and fifty'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0441886', 'cui_str': 'Class 2 (qualifier value)'}, {'cui': 'C3696954', 'cui_str': 'Precapillary pulmonary hypertension'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by (contextual qualifier) (qualifier value)'}, {'cui': 'C0189896', 'cui_str': 'Catheterization of right heart (procedure)'}, {'cui': 'C0871470', 'cui_str': 'Systolic Pressure'}, {'cui': 'C0311392', 'cui_str': 'Sign'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0020649', 'cui_str': 'Blood Pressure, Low'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2717561', 'cui_str': 'riociguat'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0556984', 'cui_str': 'Three times daily (qualifier value)'}]","[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0205555', 'cui_str': 'Special (qualifier value)'}, {'cui': 'C0019079', 'cui_str': 'Hemoptysis'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0020649', 'cui_str': 'Blood Pressure, Low'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C2717561', 'cui_str': 'riociguat'}, {'cui': 'C0085649', 'cui_str': 'Peripheral edema (morphologic abnormality)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0429886', 'cui_str': 'Walking distance (observable entity)'}]",229.0,0.546608,"Riociguat did not improve 6MWD versus placebo at 26 weeks (least-squares mean difference 21 m; 95% CI -9 to 52). ","[{'ForeName': 'Steven D', 'Initials': 'SD', 'LastName': 'Nathan', 'Affiliation': 'The Advanced Lung Disease and Transplant Program, Department of Medicine, Inova Fairfax Hospital, Falls Church, VA, USA. Electronic address: steven.nathan@inova.org.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Behr', 'Affiliation': 'Department of Internal Medicine V, Ludwig Maximilians University of Munich, Munich, Germany; Asklepios Fachkliniken München-Gauting, German Center for Lung Research, Munich, Germany.'}, {'ForeName': 'Harold R', 'Initials': 'HR', 'LastName': 'Collard', 'Affiliation': 'Department of Medicine, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Cottin', 'Affiliation': 'Department of Respiratory Medicine, Louis Pradel Hospital, Hospices Civils de Lyon, Lyon, France.'}, {'ForeName': 'Marius M', 'Initials': 'MM', 'LastName': 'Hoeper', 'Affiliation': 'Clinic for Respiratory Medicine, Hannover Medical School, German Center for Lung Research, Hannover, Germany.'}, {'ForeName': 'Fernando J', 'Initials': 'FJ', 'LastName': 'Martinez', 'Affiliation': 'Department of Medicine, Weill Cornell Medical College, New York-Presbyterian Hospital/Weill Cornell Medical Center, New York, NY, USA.'}, {'ForeName': 'Tamera J', 'Initials': 'TJ', 'LastName': 'Corte', 'Affiliation': 'Royal Prince Alfred Hospital, Sydney, NSW, Australia; University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Anne M', 'Initials': 'AM', 'LastName': 'Keogh', 'Affiliation': ""St Vincent's Hospital, Sydney, NSW, Australia.""}, {'ForeName': 'Hanno', 'Initials': 'H', 'LastName': 'Leuchte', 'Affiliation': 'Department of Internal Medicine II, Neuwittelsbach Academic Hospital, Ludwig Maximilian University of Munich, Munich, Germany.'}, {'ForeName': 'Nesrin', 'Initials': 'N', 'LastName': 'Mogulkoc', 'Affiliation': 'Pulmonology, Ege University Hospital, Izmir, Turkey.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Ulrich', 'Affiliation': 'Clinic of Pulmonology, University Hospital Zürich, Zürich, Switzerland.'}, {'ForeName': 'Wim A', 'Initials': 'WA', 'LastName': 'Wuyts', 'Affiliation': 'Unit for Interstitial Lung Diseases, University of Leuven, Leuven, Belgium.'}, {'ForeName': 'Zhen', 'Initials': 'Z', 'LastName': 'Yao', 'Affiliation': 'Bayer HealthCare, Beijing, China.'}, {'ForeName': 'Francis', 'Initials': 'F', 'LastName': 'Boateng', 'Affiliation': 'Bayer HealthCare Pharmaceuticals, Whippany, NY, USA.'}, {'ForeName': 'Athol U', 'Initials': 'AU', 'LastName': 'Wells', 'Affiliation': 'Royal Brompton Hospital, London, UK.'}]",The Lancet. Respiratory medicine,['10.1016/S2213-2600(19)30250-4'] 1590,31810217,"A Randomised Trial to Optimise Gestational Weight Gain and Improve Maternal and Infant Health Outcomes through Antenatal Dietary, Lifestyle and Exercise Advice: The OPTIMISE Randomised Trial.","There are well-recognised associations between excessive gestational weight gain (GWG) and adverse pregnancy outcomes, including an increased risk of pre-eclampsia, gestational diabetes and caesarean birth. The aim of the OPTIMISE randomised trial was to evaluate the effect of dietary and exercise advice among pregnant women of normal body mass index (BMI), on pregnancy and birth outcomes. The trial was conducted in Adelaide, South Australia. Pregnant women with a body mass index in the healthy weight range (18.5-24.9 kg/m 2 ) were enrolled in a randomised controlled trial of a dietary and lifestyle intervention versus standard antenatal care. The dietitian-led dietary and lifestyle intervention over the course of pregnancy was based on the Australian Guide to Healthy Eating. Baseline characteristics of women in the two treatment groups were similar. There was no statistically significant difference in the proportion of infants with birth weight above 4.0 kg between the Lifestyle Advice and Standard Care groups (24/316 (7.59%) Lifestyle Advice versus 26/313 (8.31%) Standard Care; adjusted risk ratio (aRR) 0.91; 95% confidence interval (CI) 0.54 to 1.55; p = 0.732). Despite improvements in maternal diet quality, no significant differences between the treatment groups were observed for total GWG, or other pregnancy and birth outcomes.",2019,Standard Care; adjusted risk ratio (aRR) 0.91; 95% confidence interval (CI) 0.54 to 1.55; p = 0.732).,"['Adelaide, South Australia', 'pregnant women of normal body mass index (BMI), on pregnancy and birth outcomes', 'Pregnant women with a body mass index in the healthy weight range (18.5-24.9 kg/m 2 ']","['dietitian-led dietary and lifestyle intervention', 'dietary and lifestyle intervention versus standard antenatal care', 'dietary and exercise advice', 'Antenatal Dietary, Lifestyle and Exercise Advice']","['maternal diet quality', 'risk of pre-eclampsia, gestational diabetes and caesarean birth', 'excessive gestational weight gain (GWG) and adverse pregnancy outcomes', 'proportion of infants with birth weight', 'total GWG, or other pregnancy and birth outcomes']","[{'cui': 'C0037715', 'cui_str': 'South Australia'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0231253', 'cui_str': 'Normal body mass index (finding)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C1286282', 'cui_str': 'Birth outcome'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C4517611', 'cui_str': 'Eighteen point five'}]","[{'cui': 'C0334932', 'cui_str': 'Dietitian (general) (occupation)'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0033052', 'cui_str': 'Antenatal Care'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2828394', 'cui_str': 'Antenatal (qualifier value)'}]","[{'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0032914', 'cui_str': 'EPH Toxemias'}, {'cui': 'C0439671', 'cui_str': 'Gestational (qualifier value)'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0442802', 'cui_str': 'Excessive (qualifier value)'}, {'cui': 'C1398625', 'cui_str': 'Pregnancy Weight Gain'}, {'cui': 'C0032972', 'cui_str': 'Pregnancy Outcome'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0005612', 'cui_str': 'Birth Weight'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C1286282', 'cui_str': 'Birth outcome'}]",,0.20042,Standard Care; adjusted risk ratio (aRR) 0.91; 95% confidence interval (CI) 0.54 to 1.55; p = 0.732).,"[{'ForeName': 'Jodie M', 'Initials': 'JM', 'LastName': 'Dodd', 'Affiliation': 'Discipline of Obstetrics & Gynaecology, and Robinson Research Institute, The University of Adelaide, Adelaide, SA 5006, Australia.'}, {'ForeName': 'Andrea R', 'Initials': 'AR', 'LastName': 'Deussen', 'Affiliation': 'Discipline of Obstetrics & Gynaecology, and Robinson Research Institute, The University of Adelaide, Adelaide, SA 5006, Australia.'}, {'ForeName': 'Jennie', 'Initials': 'J', 'LastName': 'Louise', 'Affiliation': 'Discipline of Obstetrics & Gynaecology, and Robinson Research Institute, The University of Adelaide, Adelaide, SA 5006, Australia.'}]",Nutrients,['10.3390/nu11122911'] 1591,31046521,"Sildenafil enhances central hemodynamic responses to exercise, but not V̇o 2peak , in people with diabetes mellitus.","Exercise capacity is frequently reduced in people with diabetes mellitus (DM), and the contribution of pulmonary microvascular dysfunction remains undefined. We hypothesized that pulmonary microvascular disease, measured by a novel exercise echocardiography technique termed pulmonary transit of agitated contrast (PTAC), would be greater in subjects with DM and that the use of pulmonary vasodilator agent sildenafil would improve exercise performance by reducing right ventricular afterload. Forty subjects with DM and 20 matched controls performed cardiopulmonary exercise testing and semisupine exercise echocardiography 1 h after placebo or sildenafil ingestion in a double-blind randomized crossover design. The primary efficacy end point was exercise capacity (V̇o 2peak ) while secondary measures included pulmonary vascular resistance, cardiac output, and change in PTAC. DM subjects were aged 44 ± 13 yr, 73% male, with 16 ± 10 yr DM history. Sildenafil caused marginal improvements in echocardiographic measures of biventricular systolic function in DM subjects. Exercise-induced increases in pulmonary artery systolic pressure and pulmonary vascular resistance were attenuated with sildenafil, while heart rate (+2.4 ±1.2 beats/min, P = 0.04) and cardiac output (+322 ± 21 ml, P = 0.03) improved. However, the degree of PTAC did not change ( P = 0.93) and V̇o 2peak did not increase following sildenafil as compared with placebo (V̇o 2peak : 31.8 ± 9.7 vs. 32.1 ± 9.5 ml·min -1 ·kg -1 , P = 0.42). We conclude that sildenafil administration causes modest acute improvements in central hemodynamics but does not improve exercise capacity. This may be due to the mismatch in action of sildenafil on the pulmonary arteries rather than the distal pulmonary microvasculature and potential adverse effects on peripheral oxygen extraction. NEW & NOTEWORTHY This is one of the largest and most comprehensive studies of cardiopulmonary exercise performance in people with diabetes mellitus and to our knowledge the first to assess the effect of sildenafil using detailed echocardiographic measures during incremental exercise. Sildenafil attenuated the rise in pulmonary vascular resistance while augmenting cardiac output and intriguingly heart rate, without conferring any improvement in exercise capacity. The enhanced central hemodynamic indexes may have been offset by reduced peripheral O 2 extraction.",2019,"Exercise-induced increases in pulmonary artery systolic pressure and pulmonary vascular resistance were attenuated with sildenafil, while heart rate (+2.4 ±1.2 beats/min, P = 0.04) and cardiac output (+322 ± 21 ml, P = 0.03) improved.","['DM subjects were aged 44\u2009±\u200913 yr, 73% male, with 16\u2009±\u200910 yr DM history', 'Forty subjects with DM and 20 matched controls performed', 'people with diabetes mellitus (DM', 'DM subjects', 'people with diabetes mellitus']","['placebo', 'Sildenafil', 'sildenafil', 'cardiopulmonary exercise performance', 'cardiopulmonary exercise testing and semisupine exercise echocardiography 1 h after placebo or sildenafil ingestion']","['cardiac output', 'heart rate', 'exercise performance', 'echocardiographic measures of biventricular systolic function', 'pulmonary artery systolic pressure and pulmonary vascular resistance', 'pulmonary vascular resistance', 'exercise capacity', 'pulmonary vascular resistance, cardiac output, and change in PTAC', 'Exercise capacity', 'exercise capacity (V̇o 2peak ']","[{'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0019665', 'cui_str': 'historical aspects'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0529793', 'cui_str': 'sildenafil'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0013516', 'cui_str': 'Transthoracic Echocardiography'}, {'cui': 'C0700308', 'cui_str': 'Protium (substance)'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}]","[{'cui': 'C0007165', 'cui_str': 'Cardiac Output'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0428643', 'cui_str': 'Pulmonary artery systolic pressure (observable entity)'}, {'cui': 'C0456261', 'cui_str': 'Pulmonary Vascular Resistance'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0760635', 'cui_str': 'PTAC'}]",40.0,0.431972,"Exercise-induced increases in pulmonary artery systolic pressure and pulmonary vascular resistance were attenuated with sildenafil, while heart rate (+2.4 ±1.2 beats/min, P = 0.04) and cardiac output (+322 ± 21 ml, P = 0.03) improved.","[{'ForeName': 'Timothy J', 'Initials': 'TJ', 'LastName': 'Roberts', 'Affiliation': ""Department of Cardiology, St. Vincent's Hospital Melbourne , Fitzroy , Australia.""}, {'ForeName': 'Andrew T', 'Initials': 'AT', 'LastName': 'Burns', 'Affiliation': ""Department of Cardiology, St. Vincent's Hospital Melbourne , Fitzroy , Australia.""}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'MacIsaac', 'Affiliation': ""St. Vincent's Department of Medicine, University of Melbourne , Fitzroy , Australia.""}, {'ForeName': 'Andrew I', 'Initials': 'AI', 'LastName': 'MacIsaac', 'Affiliation': ""Department of Cardiology, St. Vincent's Hospital Melbourne , Fitzroy , Australia.""}, {'ForeName': 'David L', 'Initials': 'DL', 'LastName': 'Prior', 'Affiliation': ""Department of Cardiology, St. Vincent's Hospital Melbourne , Fitzroy , Australia.""}, {'ForeName': 'André', 'Initials': 'A', 'LastName': 'La Gerche', 'Affiliation': ""Department of Cardiology, St. Vincent's Hospital Melbourne , Fitzroy , Australia.""}]","Journal of applied physiology (Bethesda, Md. : 1985)",['10.1152/japplphysiol.00947.2018'] 1592,31074652,Apocynin and Tempol ameliorate dietary sodium-induced declines in cutaneous microvascular function in salt-resistant humans.,"It has previously been shown that high dietary salt impairs vascular function independent of changes in blood pressure. Rodent studies suggest that NADPH-derived reactive oxygen species mediate the deleterious effect of high salt on the vasculature, and here we translate these findings to humans. Twenty-nine healthy adults (34 ± 2 yr) participated in a controlled feeding study. Participants completed 7 days of a low-sodium diet (LS; 20 mmol sodium/day) and 7 days of a high-sodium diet (HS; 300 mmol sodium/day) in random order. All participants were salt resistant, defined as a ≤5-mmHg change in 24-h mean BP determined while on the LS and HS diets. Laser Doppler flowmetry was used to assess cutaneous vasodilation in response to local heating (42°C) during local delivery of Ringer's ( n = 29), 20 mM ascorbic acid (AA; n = 29), 10 µM Tempol ( n = 22), and 100 µM apocynin ( n = 22). Additionally, endothelial cells were obtained in a subset of participants from an antecubital vein and stained for nitrotyrosine ( n = 14). Cutaneous vasodilation was attenuated by the HS diet compared with LS [LS 93.0 ± 2.2 vs. HS 86.8 ± 2.0 percentage of maximal cutaneous vascular conductance (%CVC max) ; P < 0.05] and was restored by AA during the HS diet (AA 90.7 ± 1.2 %CVC max ; P < 0.05 vs. HS). Cutaneous vasodilation was also restored with the local infusion of both apocynin ( P < 0.01) and Tempol ( P < 0.05) on the HS diet. Nitrotyrosine expression was increased on the HS diet compared with LS ( P < 0.05). These findings provide direct evidence of dietary sodium-induced endothelial cell oxidative stress and suggest that NADPH-derived reactive oxygen species contribute to sodium-induced declines in microvascular function. NEW & NOTEWORTHY High-sodium diets have deleterious effects on vascular function, likely mediating, in part, the increased cardiovascular risk associated with a high sodium intake. Local infusion of apocynin and Tempol improved microvascular function in salt-resistant adults on a high-salt diet, providing evidence that reactive oxygen species contribute to impairments in microvascular function from high salt. This study provides insight into the blood pressure-independent mechanisms by which dietary sodium impairs vascular function. Listen to this article's corresponding podcast at https://ajpheart.podbean.com/e/dietary-sodium-oxidative-stress-and-microvascular-function/ .",2019,Cutaneous vasodilation was also restored with the local infusion of both apocynin ( P < 0.01) and Tempol ( P < 0.05) on the HS diet.,"['salt-resistant adults', 'Twenty-nine healthy adults (34\u2009±\u20092 yr) participated in a controlled feeding study', 'salt-resistant humans']","['Laser Doppler flowmetry', 'Apocynin and Tempol ameliorate dietary sodium', 'low-sodium diet (LS; 20 mmol sodium/day) and 7 days of a high-sodium diet (HS; 300 mmol sodium/day) in random order', '20 mM ascorbic acid (AA; n = 29), 10 µM Tempol', 'apocynin and Tempol']","['Cutaneous vasodilation', 'maximal cutaneous vascular conductance', 'microvascular function', 'cutaneous microvascular function', 'Nitrotyrosine expression', 'endothelial cells']","[{'cui': 'C0036140', 'cui_str': 'Salts'}, {'cui': 'C0332325', 'cui_str': 'Resistant (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0450351', 'cui_str': '29 (qualifier value)'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C0162520', 'cui_str': 'Laser-Doppler Flowmetry'}, {'cui': 'C0050465', 'cui_str': 'apocynine'}, {'cui': 'C0045283', 'cui_str': '4-hydroxy-2,2,6,6-tetramethylpiperidinyl-1-oxy'}, {'cui': 'C0037570', 'cui_str': 'Sodium, Dietary'}, {'cui': 'C0012169', 'cui_str': 'Diet, Low-Salt'}, {'cui': 'C0439190', 'cui_str': 'mmol'}, {'cui': 'C3541959', 'cui_str': 'Sodium supplement (substance)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0452340', 'cui_str': 'High sodium diet'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0439605', 'cui_str': 'Random (qualifier value)'}, {'cui': 'C4284072', 'cui_str': 'Order (record artifact)'}, {'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}]","[{'cui': 'C4521174', 'cui_str': 'Cutaneous'}, {'cui': 'C0042401', 'cui_str': 'Vasorelaxation'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0443258', 'cui_str': 'Microvascular (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0047645', 'cui_str': 'nitrotyrosine'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0225336', 'cui_str': 'Endothelial Cells'}]",29.0,0.0278053,Cutaneous vasodilation was also restored with the local infusion of both apocynin ( P < 0.01) and Tempol ( P < 0.05) on the HS diet.,"[{'ForeName': 'Meghan G', 'Initials': 'MG', 'LastName': 'Ramick', 'Affiliation': 'Department of Kinesiology and Applied Physiology, University of Delaware , Newark, Delaware.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Brian', 'Affiliation': 'Department of Kinesiology and Applied Physiology, University of Delaware , Newark, Delaware.'}, {'ForeName': 'Evan L', 'Initials': 'EL', 'LastName': 'Matthews', 'Affiliation': 'Department of Kinesiology and Applied Physiology, University of Delaware , Newark, Delaware.'}, {'ForeName': 'Jordan C', 'Initials': 'JC', 'LastName': 'Patik', 'Affiliation': 'Department of Kinesiology and Applied Physiology, University of Delaware , Newark, Delaware.'}, {'ForeName': 'Douglas R', 'Initials': 'DR', 'LastName': 'Seals', 'Affiliation': 'Department of Integrative Physiology, University of Colorado Boulder , Boulder, Colorado.'}, {'ForeName': 'Shannon L', 'Initials': 'SL', 'LastName': 'Lennon', 'Affiliation': 'Department of Kinesiology and Applied Physiology, University of Delaware , Newark, Delaware.'}, {'ForeName': 'William B', 'Initials': 'WB', 'LastName': 'Farquhar', 'Affiliation': 'Department of Kinesiology and Applied Physiology, University of Delaware , Newark, Delaware.'}, {'ForeName': 'David G', 'Initials': 'DG', 'LastName': 'Edwards', 'Affiliation': 'Department of Kinesiology and Applied Physiology, University of Delaware , Newark, Delaware.'}]",American journal of physiology. Heart and circulatory physiology,['10.1152/ajpheart.00786.2018'] 1593,32140784,Eldecalcitol is superior to alfacalcidol in maintaining bone mineral density in glucocorticoid-induced osteoporosis patients (e-GLORIA).,"INTRODUCTION Eldecalcitol increases bone mineral density (BMD) and reduces vertebral fracture in patients with primary osteoporosis. However, the effect of eldecalcitol on BMD and fracture in glucocorticoid-induced osteoporosis (GIO) patients is unknown. This study was undertaken to compare the effect of eldecalcitol on BMD and fracture with that of alfacalcidol in GIO patients. MATERIALS AND METHODS A randomized, open-label, parallel group study was conducted to identify the effectiveness and safety of monotherapy with 0.75 μg eldecalcitol compared with 1.0 μg alfacalcidol in GIO patients. RESULTS Lumbar spine BMD increased with eldecalcitol, but decreased with alfacalcidol at 12 and 24 months (between group difference 1.29%, p < 0.01, and 1.10%, p < 0.05, respectively). Total hip and femoral neck BMD were maintained until 24 months by eldecalcitol, but decreased by alfacalcidol (between group difference 0.97%, p < 0.05 and 1.22%, p < 0.05, respectively). Both bone formation and resorption markers were more strongly suppressed by eldecalcitol than by alfacalcidol. Eldecalcitol showed better effect on BMD than alfacalcidol in patients with no prevalent fracture and BMD > 70% of the young adult mean, and with ≤ 3 months of previous glucocorticoid treatment. No significant difference in the incidence of vertebral fracture was found, and the incidence of adverse events was similar between the two groups. CONCLUSIONS Eldecalcitol was more effective than alfacalcidol in maintaining BMD in GIO patients. Because eldecalcitol was effective in patients with no or short-term previous glucocorticoid treatment, as well as those without prevalent fracture or low BMD, eldecalcitol can be a good candidate for primary prevention of GIO. CLINICAL TRIAL REGISTRATION NUMBER UMIN000011700.",2020,"No significant difference in the incidence of vertebral fracture was found, and the incidence of adverse events was similar between the two groups. ","['GIO patients', 'patients with primary osteoporosis']","['monotherapy', 'Eldecalcitol', 'eldecalcitol']","['bone mineral density', 'incidence of adverse events', 'incidence of vertebral fracture', 'bone mineral density (BMD', 'effectiveness and safety', 'vertebral fracture', 'BMD', 'bone formation and resorption markers', 'Lumbar spine BMD', 'Total hip and femoral neck BMD']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0410438', 'cui_str': 'Primary osteoporosis (disorder)'}]","[{'cui': 'C2828245', 'cui_str': '2-(3-hydroxypropoxy)calcitriol'}]","[{'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0080179', 'cui_str': 'Spinal Fractures'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0029433', 'cui_str': 'Ossification'}, {'cui': 'C3887615', 'cui_str': 'Lumbar spine structure (body structure)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0019552', 'cui_str': 'Coxa'}, {'cui': 'C0015815', 'cui_str': 'Femoral Neck'}]",,0.0374739,"No significant difference in the incidence of vertebral fracture was found, and the incidence of adverse events was similar between the two groups. ","[{'ForeName': 'Toshio', 'Initials': 'T', 'LastName': 'Matsumoto', 'Affiliation': 'Fujii Memorial Institute of Medical Sciences, Tokushima University, Tokushima, 770-8530, Japan. toshio.matsumoto@tokushima-u.ac.jp.'}, {'ForeName': 'Kazuhiko', 'Initials': 'K', 'LastName': 'Yamamoto', 'Affiliation': 'Laboratory for Autoimmune Diseases, RIKEN Center for Integrative Medical Sciences, Yokohama, Kanagawa, Japan.'}, {'ForeName': 'Tsutomu', 'Initials': 'T', 'LastName': 'Takeuchi', 'Affiliation': 'Division of Rheumatology, Department of Internal Medicine, School of Medicine, Keio University, Tokyo, Japan.'}, {'ForeName': 'Yoshiya', 'Initials': 'Y', 'LastName': 'Tanaka', 'Affiliation': 'First Department of Internal Medicine, School of Medicine, University of Occupational and Environmental Health, Kitakyushu, Fukuoka, Japan.'}, {'ForeName': 'Sakae', 'Initials': 'S', 'LastName': 'Tanaka', 'Affiliation': 'Department of Orthopaedic Surgery, The University of Tokyo Graduate School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Tetsuo', 'Initials': 'T', 'LastName': 'Nakano', 'Affiliation': 'Tamana Central Hospital, Tamana, Kumamoto, Japan.'}, {'ForeName': 'Masako', 'Initials': 'M', 'LastName': 'Ito', 'Affiliation': 'The Open University of Japan, Nagasaki, Nagasaki, Japan.'}, {'ForeName': 'Tatsushi', 'Initials': 'T', 'LastName': 'Tomomitsu', 'Affiliation': 'Department of Radiology, Kawasaki Medical School, Kurashiki, Okayama, Japan.'}, {'ForeName': 'Akihiro', 'Initials': 'A', 'LastName': 'Hirakawa', 'Affiliation': 'Department of Biostatistics and Bioinformatics, The University of Tokyo Graduate School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Soen', 'Affiliation': 'Department of Orthopaedic Surgery and Rheumatology, Kindai University Nara Hospital, Ikoma, Nara, Japan.'}]",Journal of bone and mineral metabolism,['10.1007/s00774-020-01091-4'] 1594,31386976,Do the type of walking surface and the horse speed during hippotherapy modify the dynamics of sitting postural control in children with cerebral palsy?,"BACKGROUND Hippotherapy is described as a rehabilitation method for postural control in children with cerebral palsy. Horse's movements can be manipulated during hippotherapy's sessions with horse walking on different surfaces and at different speeds. The purpose of this study was to assess if dynamic sitting postural control in children with cerebral palsy in hippotherapy is modified when surfaces (sand or asphalt) and horse's walking speed (slow or faster) are changed. METHODS Sixteen children participated in this crossover study. Eight bilateral spastic cerebral palsy children, age range (6-12 years), with Gross Motor Function Classification System levels III to IV, practicing hippotherapy and eight children with typical development (reference group), matched for age and sex. All children were evaluated during riding a horse on sand and asphalt surfaces and at slow (self-selected) and faster (30%) horse's walking speed. Center of pressure parameters were determined by a portable pressure measurement system positioned on the saddle. FINDINGS Mediolateral displacement amplitude of the center of pressure was larger when the horse was on sand. Mediolateral and anteroposterior displacements amplitude and velocities of the center of pressure increased at horse's faster walking speed. INTERPRETATION Our study test empirical procedures used in clinical practice and with a population widely reached by hippotherapy. In order to increase the demand for sitting postural control in children with cerebral palsy during horse riding, faster horse speed or riding on sand should be used.",2019,"Mediolateral and anteroposterior displacements amplitude and velocities of the center of pressure increased at horse's faster walking speed. ","[""All children were evaluated during riding a horse on sand and asphalt surfaces and at slow (self-selected) and faster (30%) horse's walking speed"", 'Eight bilateral spastic cerebral palsy children, age range (6-12\u202fyears), with Gross Motor Function Classification System levels III to IV, practicing hippotherapy and eight children with typical development (reference group), matched for age and sex', 'children with cerebral palsy during horse riding', 'children with cerebral palsy', 'Sixteen children participated in this crossover study']",['dynamic sitting postural control'],['Mediolateral and anteroposterior displacements amplitude and velocities of the center of pressure'],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0242616', 'cui_str': 'Equidae'}, {'cui': 'C0037098', 'cui_str': 'Silicon Dioxide'}, {'cui': 'C0052558', 'cui_str': 'asphalt'}, {'cui': 'C0205148', 'cui_str': 'Surface (attribute)'}, {'cui': 'C0439834', 'cui_str': 'Slowly'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C3838784', 'cui_str': 'Bilateral spastic cerebral palsy'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677549', 'cui_str': 'Gross motor functions (observable entity)'}, {'cui': 'C0008902', 'cui_str': 'Systematics'}, {'cui': 'C0441927', 'cui_str': 'Level III (tumor staging)'}, {'cui': 'C0454416', 'cui_str': 'Hippotherapies'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0007789', 'cui_str': 'CP (Cerebral Palsy)'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0150097', 'cui_str': 'Crossover Trials'}]","[{'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C2584297', 'cui_str': 'Seated Position'}, {'cui': 'C0205278', 'cui_str': 'Postural (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0441992', 'cui_str': 'Mediolateral (qualifier value)'}, {'cui': 'C0456080', 'cui_str': 'Displacement (attribute)'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}]",16.0,0.0160924,"Mediolateral and anteroposterior displacements amplitude and velocities of the center of pressure increased at horse's faster walking speed. ","[{'ForeName': 'Fabiana Moraes', 'Initials': 'FM', 'LastName': 'Flores', 'Affiliation': 'Functional Rehabilitation Graduate Program, Universidade Federal de Santa Maria, Brazil.'}, {'ForeName': 'Frederico', 'Initials': 'F', 'LastName': 'Dagnese', 'Affiliation': 'Biomechanics Laboratory, Universidade Federal de Santa Maria, Brazil.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Copetti', 'Affiliation': 'Center of Physical Education and Sports, Universidade Federal de Santa Maria, Brazil. Electronic address: fernando.copetti@ufsm.br.'}]","Clinical biomechanics (Bristol, Avon)",['10.1016/j.clinbiomech.2019.07.030'] 1595,31410473,Nurse-led care is preferred over GP-led care of gout and improves gout outcomes: results of Nottingham Gout Treatment Trial follow-up study.,"OBJECTIVES To explore patient satisfaction, gout knowledge, medication adherence and flares among participants receiving nurse-led or general practitioner (GP)-led care of gout in the Nottingham Gout Treatment Trial phase-II (NGTT-II). METHODS A total of 438 participants of NGTT-II were sent a questionnaire enquiring about gout knowledge, satisfaction with health-care practitioner, urate-lowering treatment being undertaken, and gout flares ⩾1 year after their final visit. Nurse-led care participants were asked about their preference for receiving gout treatment from either a GP or a nurse. RESULTS Completed questionnaires were returned by 82% of participants. Participants previously receiving nurse-led care reported greater satisfaction with health-care practitioner (P < 0.001), had better gout knowledge (P = 0.02), were more likely to be taking urate-lowering treatment [adjusted relative risk (95% CI) 1.19 (1.09, 1.30)], and self-reported fewer flares in the previous 12 months [median (inter-quartile range) 0 (0-0) vs 1 (0-3), P < 0.001] than those receiving GP-led care. Of participants receiving nurse-led care, 41-63% indicated preference for receiving gout treatment from a nurse, while only 5-20% indicated preference for receiving treatment from GPs. CONCLUSION The results of this study favour nurse-led care, involving individualized patient education and engagement and a treat-to-target strategy, in terms of patient acceptability, long-term adherence, and flares. Further research is required to evaluate the feasibility of implementing such a model of care in clinical practice.",2020,"Participants previously receiving nurse-led care reported greater satisfaction with health-care practitioner (P < 0.001), had better gout knowledge (P = 0.02), were more likely to be taking urate-lowering treatment [adjusted relative risk (95% CI) 1.19 (1.09, 1.30)], and self-reported fewer flares in the previous 12 months [median (inter-quartile range) 0","['participants receiving nurse-led or general practitioner (GP)-led care of gout in the Nottingham Gout Treatment Trial phase-II (NGTT-II', '438 participants of NGTT-II were sent a questionnaire enquiring about gout knowledge, satisfaction with health-care practitioner, urate-lowering treatment being undertaken, and gout flares ⩾1 year after their final visit']",[],"['satisfaction with health-care practitioner', 'gout knowledge']","[{'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0017319', 'cui_str': 'Physicians, General Practice'}, {'cui': 'C0018099', 'cui_str': 'Gout'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C0935936', 'cui_str': 'Urate'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C0041666', 'cui_str': 'Undertaking'}, {'cui': 'C1619733', 'cui_str': 'Gout flare'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]",[],"[{'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0086388', 'cui_str': 'Health Care'}, {'cui': 'C0018099', 'cui_str': 'Gout'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}]",438.0,0.0840752,"Participants previously receiving nurse-led care reported greater satisfaction with health-care practitioner (P < 0.001), had better gout knowledge (P = 0.02), were more likely to be taking urate-lowering treatment [adjusted relative risk (95% CI) 1.19 (1.09, 1.30)], and self-reported fewer flares in the previous 12 months [median (inter-quartile range) 0","[{'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Fuller', 'Affiliation': 'Academic Rheumatology, Nottingham, UK.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Jenkins', 'Affiliation': 'Academic Rheumatology, Nottingham, UK.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Doherty', 'Affiliation': 'Academic Rheumatology, Nottingham, UK.'}, {'ForeName': 'Abhishek', 'Initials': 'A', 'LastName': 'Abhishek', 'Affiliation': 'Academic Rheumatology, Nottingham, UK.'}]","Rheumatology (Oxford, England)",['10.1093/rheumatology/kez333'] 1596,31789000,Comparison of rivaroxaban and dalteparin for the long-term treatment of venous thromboembolism in patients with gynecologic cancers.,"OBJECTIVES Two randomized, controlled studies comparing outcomes in patients treated with direct oral anticoagulants or low-molecular weight heparin for cancer-associated venous thromboembolism (VTE) have previously been performed. However, gynecologic cancers accounted for approximately 10% of the study populations. We compared the outcomes of patients with primary gynecological cancers who were treated for cancer-associated VTE with either rivaroxaban or dalteparin. METHODS The 162 eligible patients with gynecologic cancers who were treated with either dalteparin (n=60) or rivaroxaban (n=102) were reviewed. The primary outcome was a composite event, which included recurrence or clinically relevant bleeding events during the therapeutic period. Secondary outcomes were recurrence, clinically relevant bleeding events, and mortality. RESULTS During the therapeutic period, there were no significant differences between the groups in the proportion of composite events, recurrence, or clinically relevant bleeding. Multivariate analysis using the Cox proportional hazards model also showed no significant difference in the number of composite events and clinically relevant bleeding between the groups. In the rivaroxaban group, 44.0% of patients experienced gastrointestinal bleeding and 24.0% experienced urinary tract bleeding. In the dalteparin group, bleeding was most common in the urinary tract (44.4%) and at the injection site (22.2%). CONCLUSION In this study, although there were no significant differences in effectiveness or safety between the rivaroxaban and dalteparin groups, rivaroxaban use was associated with a higher rate of clinically relevant bleeding than dalteparin. Therefore, caution should be taken when prescribing rivaroxaban for gynecologic cancer-associated VTE and bleeding events should be carefully monitored.",2020,Multivariate analysis using the Cox proportional hazards model also showed no significant difference in the number of composite events and clinically relevant bleeding between the groups.,"['for cancer-associated venous thromboembolism (VTE', 'n=60) or', 'n=102) were reviewed', 'patients with primary gynecological cancers who were treated for cancer-associated VTE with either', 'patients with gynecologic cancers', 'patients treated with', '162 eligible patients with gynecologic cancers who were treated with either']","['rivaroxaban and dalteparin', 'rivaroxaban', 'direct oral anticoagulants or low-molecular weight heparin', 'dalteparin', 'rivaroxaban or dalteparin']","['urinary tract bleeding', 'gastrointestinal bleeding', 'effectiveness or safety', 'gynecologic cancers', 'proportion of composite events, recurrence, or clinically relevant bleeding', 'composite event, which included recurrence or clinically relevant bleeding events', 'recurrence, clinically relevant bleeding events, and mortality', 'venous thromboembolism', 'bleeding', 'number of composite events and clinically relevant bleeding']","[{'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C1861172', 'cui_str': 'Venous Thromboembolism'}, {'cui': 'C0630906', 'cui_str': 'triethoxyvinylsilane'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for (contextual qualifier) (qualifier value)'}, {'cui': 'C0205480', 'cui_str': 'Gynecologic (qualifier value)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}]","[{'cui': 'C1739768', 'cui_str': 'rivaroxaban'}, {'cui': 'C0206461', 'cui_str': 'Dalteparin'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0003280', 'cui_str': 'Anticoagulation Agents'}, {'cui': 'C0019139', 'cui_str': 'LMWH'}]","[{'cui': 'C0235620', 'cui_str': 'Haemorrhage urinary tract'}, {'cui': 'C0017181', 'cui_str': 'Gastrointestinal Hemorrhage'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205480', 'cui_str': 'Gynecologic (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C1861172', 'cui_str': 'Venous Thromboembolism'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}]",162.0,0.0874553,Multivariate analysis using the Cox proportional hazards model also showed no significant difference in the number of composite events and clinically relevant bleeding between the groups.,"[{'ForeName': 'Jang Ho', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.'}, {'ForeName': 'Joo Hee', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.'}, {'ForeName': 'Kyung Wook', 'Initials': 'KW', 'LastName': 'Jo', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.'}, {'ForeName': 'Jin Won', 'Initials': 'JW', 'LastName': 'Huh', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.'}, {'ForeName': 'Yeon Mok', 'Initials': 'YM', 'LastName': 'Oh', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.'}, {'ForeName': 'Jae Seung', 'Initials': 'JS', 'LastName': 'Lee', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.'}]",Journal of gynecologic oncology,['10.3802/jgo.2020.31.e10'] 1597,31358017,Robot-assisted gait training for balance and lower extremity function in patients with infratentorial stroke: a single-blinded randomized controlled trial.,"BACKGROUND Balance impairments are common in patients with infratentorial stroke. Although robot-assisted gait training (RAGT) exerts positive effects on balance among patients with stroke, it remains unclear whether such training is superior to conventional physical therapy (CPT). Therefore, we aimed to investigate the effects of RAGT combined with CPT and compared them with the effects of CPT only on balance and lower extremity function among survivors of infratentorial stroke. METHODS This study was a single-blinded, randomized controlled trial with a crossover design conducted at a single rehabilitation hospital. Patients (n = 19; 16 men, three women; mean age: 47.4 ± 11.6 years) with infratentorial stroke were randomly allocated to either group A (4 weeks of RAGT+CPT, followed by 4 weeks of CPT+CPT) or group B (4 weeks of CPT+CPT followed by 4 weeks of RAGT+CPT). Changes in dynamic and static balance as indicated by Berg Balance Scale scores were regarded as the primary outcome measure. Outcome measures were evaluated for each participant at baseline and after each 4-week intervention period. RESULTS No significant differences in outcome-related variables were observed between group A and B at baseline. In addition, no significant time-by-group interactions were observed for any variables, indicating that intervention order had no effect on lower extremity function or balance. Significantly greater improvements in secondary functional outcomes such as lower extremity Fugl-Meyer assessment (FMA-LE) and scale for the assessment and rating of ataxia (SARA) were observed following the RAGT+CPT intervention than following the CPT+CPT intervention. CONCLUSION RAGT produces clinically significant improvements in balance and lower extremity function in individuals with infratentorial stroke. Thus, RAGT may be useful for patients with balance impairments secondary to other pathologies. TRIAL REGISTRATION ClinicalTrials.gov Identifier NCT02680691. Registered 09 February 2016; retrospectively registered.",2019,"Significantly greater improvements in secondary functional outcomes such as lower extremity Fugl-Meyer assessment (FMA-LE) and scale for the assessment and rating of ataxia (SARA) were observed following the RAGT+CPT intervention than following the CPT+CPT intervention. ","['Patients (n\u2009=\u200919; 16 men, three women; mean age: 47.4\u2009±\u200911.6\u2009years) with infratentorial stroke', 'patients with infratentorial stroke', 'patients with balance impairments secondary to other pathologies', 'survivors of infratentorial stroke', 'patients with stroke', 'individuals with infratentorial stroke']","['CPT+CPT followed by 4\u2009weeks of RAGT+CPT', 'RAGT+CPT', 'CPT', 'robot-assisted gait training (RAGT', 'RAGT combined with CPT', 'RAGT+CPT, followed by 4\u2009weeks of CPT+CPT', 'Robot-assisted gait training']","['balance and lower extremity function', 'Berg Balance Scale scores', 'dynamic and static balance', 'secondary functional outcomes such as lower extremity Fugl-Meyer assessment (FMA-LE) and scale for the assessment and rating of ataxia (SARA', 'lower extremity function or balance']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4708782', 'cui_str': '11.6'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0441939', 'cui_str': 'Infratentorial (qualifier value)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0241981', 'cui_str': 'Unable to balance (finding)'}, {'cui': 'C0175668', 'cui_str': 'Secondary (qualifier value)'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C4521399', 'cui_str': 'LT'}, {'cui': 'C0336537', 'cui_str': 'Robot, device (physical object)'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0085673', 'cui_str': 'Gait training procedure (procedure)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}]","[{'cui': 'C0179199', 'cui_str': 'Balance (physical object)'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C1998325', 'cui_str': 'Berg balance scale'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0729333', 'cui_str': 'Dynamic (qualifier value)'}, {'cui': 'C0441463', 'cui_str': 'Static (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0222045'}, {'cui': 'C0004134', 'cui_str': 'Dyssynergia'}]",,0.0957003,"Significantly greater improvements in secondary functional outcomes such as lower extremity Fugl-Meyer assessment (FMA-LE) and scale for the assessment and rating of ataxia (SARA) were observed following the RAGT+CPT intervention than following the CPT+CPT intervention. ","[{'ForeName': 'Ha Yeon', 'Initials': 'HY', 'LastName': 'Kim', 'Affiliation': 'Translational Research Center for Rehabilitation Robots, National Rehabilitation Center, Seoul, South Korea.'}, {'ForeName': 'Joon-Ho', 'Initials': 'JH', 'LastName': 'Shin', 'Affiliation': 'Translational Research Center for Rehabilitation Robots, National Rehabilitation Center, Seoul, South Korea. asfreelyas@gmail.com.'}, {'ForeName': 'Sung Phil', 'Initials': 'SP', 'LastName': 'Yang', 'Affiliation': 'Department of Rehabilitation Medicine, National Rehabilitation Center, 58, Samgaksan-ro, Gangbuk-gu, Seoul, 01022, Republic of Korea.'}, {'ForeName': 'Min A', 'Initials': 'MA', 'LastName': 'Shin', 'Affiliation': 'Department of Rehabilitation Medicine, National Rehabilitation Center, 58, Samgaksan-ro, Gangbuk-gu, Seoul, 01022, Republic of Korea.'}, {'ForeName': 'Stephanie Hyeyoung', 'Initials': 'SH', 'LastName': 'Lee', 'Affiliation': 'Department of Rehabilitation Medicine, National Rehabilitation Center, 58, Samgaksan-ro, Gangbuk-gu, Seoul, 01022, Republic of Korea.'}]",Journal of neuroengineering and rehabilitation,['10.1186/s12984-019-0553-5'] 1598,32233747,Exploring gender differences among treatment-seekers who use opioids versus alcohol and other drugs.,"Identifying clinical differences between opioid users (OU) and alcohol and other drug users (AOD) may help to tailor treatment to OU, particularly among the majority of OU who are not on opioid agonist treatments. Given the dearth of research on these differences, this study explored gender differences in demographic and clinical characteristics between OU and AOD. Participants (N = 506) were from a multisite, randomized controlled clinical trial of an Internet-delivered psychosocial intervention conducted in 2010-2011. Logistic regression models explored differences in demographic and clinical characteristics by substance use category within and between women and men. Women OU were more likely to be younger, White, employed, benzodiazepine users, and less likely to have children or use cocaine and cannabis than women AOD. Men OU, compared to men AOD, were more likely to be younger, White, younger at first abuse/dependence, benzodiazepine users, and reported greater psychological distress, but were less likely to be involved in criminal justice or use stimulants. Interactions by gender and substance use were also detected for age of first abuse/dependence, employment, and criminal justice involvement. These findings provide a nuanced understanding of gender differences within substance use groups to inform providers for OU seeking treatment.",2020,"Men OU, compared to men AOD, were more likely to be younger, White, younger at first abuse/dependence, benzodiazepine users, and reported greater psychological distress, but were less likely to be involved in criminal justice or use stimulants.",['Participants (N\xa0=\xa0506'],"['Internet-delivered psychosocial intervention', 'benzodiazepine']",['psychological distress'],[],"[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0005064', 'cui_str': 'Benzodiazepine Compounds'}]","[{'cui': 'C0815107', 'cui_str': 'Emotional Distress'}]",506.0,0.053569,"Men OU, compared to men AOD, were more likely to be younger, White, younger at first abuse/dependence, benzodiazepine users, and reported greater psychological distress, but were less likely to be involved in criminal justice or use stimulants.","[{'ForeName': 'Tanya C', 'Initials': 'TC', 'LastName': 'Saraiya', 'Affiliation': 'Derner School of Psychology, Adelphi University , Garden City, NY, USA.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Pavlicova', 'Affiliation': 'Department of Biostatistics, Mailman School of Public Health, Columbia University , New York, NY, USA.'}, {'ForeName': 'Mei-Chen', 'Initials': 'MC', 'LastName': 'Hu', 'Affiliation': 'Department of Biostatistics, Mailman School of Public Health, Columbia University , New York, NY, USA.'}, {'ForeName': 'Edward V', 'Initials': 'EV', 'LastName': 'Nunes', 'Affiliation': 'Department of Psychiatry and New York State Psychiatric Institute, Columbia University Medical Center , New York, NY, USA.'}, {'ForeName': 'Denise A', 'Initials': 'DA', 'LastName': 'Hien', 'Affiliation': 'Center of Alcohol Studies, Graduate School of Applied and Professional Psychology, Rutgers, The State University of New Jersey , Piscataway Township, NJ, USA.'}, {'ForeName': 'Aimee N C', 'Initials': 'ANC', 'LastName': 'Campbell', 'Affiliation': 'Department of Psychiatry and New York State Psychiatric Institute, Columbia University Medical Center , New York, NY, USA.'}]",Women & health,['10.1080/03630242.2020.1746952'] 1599,32498073,Systematic manipulations of the biological stress systems result in sex-specific compensatory stress responses and negative mood outcomes.,"Women are twice as likely as men to be diagnosed with anxiety and mood disorders. One potential underlying mechanism is sex differences in physiological and psychological responses to stress; however, no studies to date have investigated this proposed mechanism experimentally. In a double-blind, placebo-controlled design, pharmacological challenges were administered to individually suppress the hypothalamic-pituitary-adrenal (HPA) axis, or the sympathetic nervous system (SNS) prior to stress exposure, to investigate sex differences in the resulting cross talk among the physiological and psychological stress responses. Sex-specific compensatory patterns and psychological effects emerged when the stress systems were manipulated. Men demonstrated heightened SNS reactivity to stress when the HPA axis was suppressed, and greater HPA reactivity after SNS suppression. This ability to react appropriately to the stressor, even with one system, did not lead to significant negative mood effects. In women, higher baseline activation (but dampened reactivity to stress) of SNS or HPA was observed when the other system was suppressed. This was coupled with worsened mood in response to stress when either stress system was compromised. Our results indicate that men and women may be differentially sensitive to fluctuations of their stress systems. This might be a potential link that underlies the sexual dimorphism in vulnerability for psychopathology.",2020,"This ability to react appropriately to the stressor, even with one system, did not lead to significant negative mood effects.",[],['placebo'],['HPA reactivity'],[],"[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0020663', 'cui_str': 'Hypothalamic structure'}, {'cui': 'C0032002', 'cui_str': 'Disorder of pituitary gland'}, {'cui': 'C0001625', 'cui_str': 'Adrenal structure'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}]",,0.0182391,"This ability to react appropriately to the stressor, even with one system, did not lead to significant negative mood effects.","[{'ForeName': 'Nida', 'Initials': 'N', 'LastName': 'Ali', 'Affiliation': 'Department of Psychology, McGill University, Montreal, QC, Canada. nida.ali@mail.mcgill.ca.'}, {'ForeName': 'Jonas P', 'Initials': 'JP', 'LastName': 'Nitschke', 'Affiliation': 'Department of Psychology, McGill University, Montreal, QC, Canada.'}, {'ForeName': 'Cory', 'Initials': 'C', 'LastName': 'Cooperman', 'Affiliation': 'Department of Psychology, McGill University, Montreal, QC, Canada.'}, {'ForeName': 'Mark W', 'Initials': 'MW', 'LastName': 'Baldwin', 'Affiliation': 'Department of Psychology, McGill University, Montreal, QC, Canada.'}, {'ForeName': 'Jens C', 'Initials': 'JC', 'LastName': 'Pruessner', 'Affiliation': 'Faculty of Medicine, McGill Centre for Studies in Aging, McGill University, Montreal, QC, Canada.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-020-0726-8'] 1600,32493693,"Phase 3, Randomized, Double-Blind, Active-Comparator (Darbepoetin Alfa) Study of Oral Roxadustat in CKD Patients with Anemia on Hemodialysis in Japan.","BACKGROUND Roxadustat is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor approved in China for dialysis-dependent CKD anemia. METHODS This phase 3, 24-week, double-blind, double-dummy study evaluated roxadustat's noninferiority to darbepoetin alfa for hemodialysis-dependent CKD anemia. We randomly assigned Japanese patients to oral roxadustat three times weekly or to darbepoetin alfa injections once weekly, titrating doses to maintain hemoglobin between 10-12 g/dl. The primary end point was change of average hemoglobin from baseline to weeks 18-24 ( ∆ Hb 18-24 ). Secondary end points were average hemoglobin and proportion of patients with hemoglobin between 10-12 g/dl (maintenance rate) at weeks 18-24, and iron parameters. Safety assessments included treatment-emergent adverse events and adjudicated ophthalmologic findings. RESULTS We randomly assigned 303 patients to roxadustat ( n =151) or darbepoetin alfa ( n =152). The difference between roxadustat and darbepoetin alfa in ∆ Hb 18-24 was -0.02 g/dl (95% confidence interval, -0.18 to 0.15), confirming roxadustat's noninferiority to darbepoetin alfa. Average hemoglobin at weeks 18-24 with roxadustat was 10.99 g/dl (95% confidence interval: 10.88 to 11.10), confirming its efficacy. Among patients with one or more hemoglobin value during weeks 18-24, the maintenance rate was 95.2% with roxadustat and 91.3% with darbepoetin alfa. Serum iron, ferritin, and transferrin saturation remained clinically stable with roxadustat; transferrin and total iron binding capacity increased through week 4 before stabilizing. Common treatment-emergent adverse events were nasopharyngitis, shunt stenosis, diarrhea, contusion, and vomiting. The proportion of patients with new or worsening retinal hemorrhage was 32.4% with roxadustat and 36.6% with darbepoetin alfa. We observed no clinically meaningful changes in retinal thickness groups. CONCLUSIONS Roxadustat maintained hemoglobin within 10-12 g/dl in patients on hemodialysis and was noninferior to darbepoetin alfa. Treatment-emergent adverse events were consistent with previous reports. CLINICAL TRIAL REGISTRY NAME AND REGISTRATION NUMBER A Study of Intermittent Oral Dosing of ASP1517 in Hemodialysis Chronic Kidney Disease Patients with Anemia, NCT02952092 (ClinicalTrials.gov).",2020,"Serum iron, ferritin, and transferrin saturation remained clinically stable with roxadustat; transferrin and total iron binding capacity increased through week 4 before stabilizing.","['hemodialysis-dependent CKD anemia', 'Hemodialysis Chronic Kidney Disease Patients with Anemia, NCT02952092 (ClinicalTrials.gov', 'CKD Patients with Anemia on Hemodialysis in Japan', '∆', '303 patients to roxadustat ( n =151) or']","['ASP1517', 'darbepoetin alfa', 'darbepoetin alfa injections']","['proportion of patients with new or worsening retinal hemorrhage', 'Serum iron, ferritin, and transferrin saturation', 'Safety assessments included treatment-emergent adverse events and adjudicated ophthalmologic findings', 'Average hemoglobin', 'hemoglobin value', 'change of average hemoglobin', 'total iron binding capacity', 'nasopharyngitis, shunt stenosis, diarrhea, contusion, and vomiting', 'maintenance rate', 'average hemoglobin and proportion of patients with hemoglobin']","[{'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022341', 'cui_str': 'Japan'}]","[{'cui': 'C0937950', 'cui_str': 'darbepoetin alfa'}, {'cui': 'C4027177', 'cui_str': 'darbepoetin alfa Injection'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0035317', 'cui_str': 'Retinal hemorrhage'}, {'cui': 'C1318312', 'cui_str': 'Serum iron measurement'}, {'cui': 'C0015879', 'cui_str': 'Ferritin'}, {'cui': 'C1277709', 'cui_str': 'Transferrin saturation'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0029087', 'cui_str': 'Ophthalmology'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0700379', 'cui_str': 'Total iron binding capacity'}, {'cui': 'C0027441', 'cui_str': 'Nasopharyngitis'}, {'cui': 'C1142174', 'cui_str': 'Shunt stenosis'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0009938', 'cui_str': 'Contusion'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}]",303.0,0.137155,"Serum iron, ferritin, and transferrin saturation remained clinically stable with roxadustat; transferrin and total iron binding capacity increased through week 4 before stabilizing.","[{'ForeName': 'Tadao', 'Initials': 'T', 'LastName': 'Akizawa', 'Affiliation': 'Department of Nephrology, Showa University School of Medicine, Tokyo, Japan akizawa@med.showa-u.ac.jp.'}, {'ForeName': 'Manabu', 'Initials': 'M', 'LastName': 'Iwasaki', 'Affiliation': 'Department of Data Science, Yokohama City University, Yokohama, Japan.'}, {'ForeName': 'Yusuke', 'Initials': 'Y', 'LastName': 'Yamaguchi', 'Affiliation': 'Japan-Asia Data Science, Development, Astellas Pharma, Inc., Tokyo, Japan.'}, {'ForeName': 'Yoshikatsu', 'Initials': 'Y', 'LastName': 'Majikawa', 'Affiliation': 'Japan-Asia Clinical Development 2, Development, Astellas Pharma, Inc., Tokyo, Japan.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Reusch', 'Affiliation': 'Development Medical Science Urology and Nephrology, Astellas Pharma Europe B.V., Leiden, The Netherlands.'}]",Journal of the American Society of Nephrology : JASN,['10.1681/ASN.2019060623'] 1601,29474117,Improving Provider Communication about HPV Vaccines for Vaccine-Hesitant Parents Through the Use of Motivational Interviewing.,"Human papillomavirus (HPV) vaccine uptake is below that of other routine adolescent vaccines. This is due in part to the fact that the HPV vaccine is often not routinely recommended by providers to all eligible adolescents. While providers' recommendations are crucial, even a strongly stated recommendation can be insufficient among HPV vaccine-hesitant parents. Providers must be prepared to respond to parental concerns following giving the recommendation for the HPV vaccine. This paper presents the analysis of implementation of an intervention aimed at improving provider communication with HPV vaccine-hesitant parents. Healthcare providers and staff at eight pediatric and family medicine clinics received communication training that included motivational interviewing (MI) techniques. Process evaluation in the form of serial surveys, as well as program evaluation in the form of focus groups with participating providers and staff, assessed the perceived efficacy of the intervention. Outcomes included time spent discussing the HPV vaccine during clinical visits, providers' self-efficacy for addressing parental HPV vaccine hesitancy, and their general perceptions of the effectiveness of MI techniques. Overall, findings indicate the intervention improved providers' communication with HPV vaccine-hesitant parents and providers reported the use of MI played a central role in improved HPV vaccine acceptance. Lessons learned and recommendations for future interventions are also discussed.",2018,"Outcomes included time spent discussing the HPV vaccine during clinical visits, providers' self-efficacy for addressing parental HPV vaccine hesitancy, and their general perceptions of the effectiveness of MI techniques.",['Healthcare providers and staff at eight pediatric and family medicine clinics'],"['HPV vaccine', 'communication training that included motivational interviewing (MI) techniques', 'HPV vaccine-hesitant parents']","['HPV vaccine acceptance', ""time spent discussing the HPV vaccine during clinical visits, providers' self-efficacy for addressing parental HPV vaccine hesitancy, and their general perceptions of the effectiveness of MI techniques""]","[{'cui': 'C0018724', 'cui_str': 'Healthcare Workers'}, {'cui': 'C2700616', 'cui_str': 'Manpowers'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C3833703', 'cui_str': 'Family medicine clinic (environment)'}]","[{'cui': 'C1512511', 'cui_str': 'HPV Vaccines'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}]","[{'cui': 'C1512511', 'cui_str': 'HPV Vaccines'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0376649', 'cui_str': 'Address'}, {'cui': 'C0152032', 'cui_str': 'Delay when starting to pass urine (finding)'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0025664', 'cui_str': 'techniques'}]",,0.0247254,"Outcomes included time spent discussing the HPV vaccine during clinical visits, providers' self-efficacy for addressing parental HPV vaccine hesitancy, and their general perceptions of the effectiveness of MI techniques.","[{'ForeName': 'Jenna E', 'Initials': 'JE', 'LastName': 'Reno', 'Affiliation': 'a Adult and Child Consortium for Health Outcomes Research and Delivery Science , University of Colorado Denver , Aurora , USA.'}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': ""O'Leary"", 'Affiliation': 'a Adult and Child Consortium for Health Outcomes Research and Delivery Science , University of Colorado Denver , Aurora , USA.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Garrett', 'Affiliation': 'b Department of Behavioral & Behavioral Health , University of Colorado Denver , USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Pyrzanowski', 'Affiliation': 'a Adult and Child Consortium for Health Outcomes Research and Delivery Science , University of Colorado Denver , Aurora , USA.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Lockhart', 'Affiliation': 'a Adult and Child Consortium for Health Outcomes Research and Delivery Science , University of Colorado Denver , Aurora , USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Campagna', 'Affiliation': 'a Adult and Child Consortium for Health Outcomes Research and Delivery Science , University of Colorado Denver , Aurora , USA.'}, {'ForeName': 'Juliana', 'Initials': 'J', 'LastName': 'Barnard', 'Affiliation': 'a Adult and Child Consortium for Health Outcomes Research and Delivery Science , University of Colorado Denver , Aurora , USA.'}, {'ForeName': 'Amanda F', 'Initials': 'AF', 'LastName': 'Dempsey', 'Affiliation': 'a Adult and Child Consortium for Health Outcomes Research and Delivery Science , University of Colorado Denver , Aurora , USA.'}]",Journal of health communication,['10.1080/10810730.2018.1442530'] 1602,32498613,The effects of psychological inoculation on condom use tendencies and barriers; a randomized controlled trial.,"Objective: Condom use prevents the contraction of the HIV. Research shows limited effects of education on increasing condom use. Psychological inoculation (PI) has been found to be more effective in this domain, however, its mechanism is unknown. This study examined effects of PI versus education on condom use barriers and tendencies, and its relations with cognitive dissonance, using a fully automatized online system. Design: The study was a randomized controlled trial (RCT) and included 149 students from a German University randomly assigned to PI or a control condition. Main outcome measures: An indirect condom use test (I-CUTE), a condom use barriers questionnaire, self-reported condom use, and cognitive dissonance estimations were all assessed at baseline and one-month post-intervention. Results: PI significantly increased I-CUTE scores when participants had sexual relations. Control participants increased in self-reported condom use and on I-CUTE scores in people without sexual relations. No changes in barriers were seen in either group. The cognitive dissonance tended to be higher in PI participants as compared to control participants. Conclusions: PI increases I-CUTE scores compared to controls (based on effect sizes), and significantly in those with sexual relations. The role of relationship status and the mechanisms of PI should be further examined.",2020,Control participants increased in self-reported condom use and on I-CUTE scores in people without sexual relations.,['149 students from a German University randomly assigned to PI or a control condition'],"['PI versus education', 'psychological inoculation', 'Psychological inoculation (PI']","['self-reported condom use and on I-CUTE scores', 'cognitive dissonance', 'I-CUTE scores', 'indirect condom use test (I-CUTE), a condom use barriers questionnaire, self-reported condom use, and cognitive dissonance estimations']","[{'cui': 'C5191071', 'cui_str': '149'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0017477', 'cui_str': 'German language'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]","[{'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0009242', 'cui_str': 'Cognitive Dissonance'}, {'cui': 'C0439852', 'cui_str': 'Indirect'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}]",149.0,0.046391,Control participants increased in self-reported condom use and on I-CUTE scores in people without sexual relations.,"[{'ForeName': 'Einav', 'Initials': 'E', 'LastName': 'Levy', 'Affiliation': 'Faculty of Medicine and Pharmacy, Free University of Brussels (VUB), Brussels, Belgium.'}, {'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'Warner', 'Affiliation': 'Department of Psychology, Health Psychology, Faculty of Natural Sciences, MSB Medical School Berlin, Berlin, Germany.'}, {'ForeName': 'Lena', 'Initials': 'L', 'LastName': 'Fleig', 'Affiliation': 'Department of Psychology, Health Psychology, Faculty of Natural Sciences, MSB Medical School Berlin, Berlin, Germany.'}, {'ForeName': 'Michelle R', 'Initials': 'MR', 'LastName': 'Kaufman', 'Affiliation': 'Department of Health, Behavior & Society, Blomberg School of Public Health, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Reginald', 'Initials': 'R', 'LastName': 'Deschepper', 'Affiliation': 'Faculty of Medicine and Pharmacy, Free University of Brussels (VUB), Brussels, Belgium.'}, {'ForeName': 'Yori', 'Initials': 'Y', 'LastName': 'Gidron', 'Affiliation': 'The Israeli School of Humanitarian Action, Tel Aviv, Israel.'}]",Psychology & health,['10.1080/08870446.2020.1775832'] 1603,32497217,Effects of Proximal and Distal Enteral Glucose Infusion on Cardiovascular Response in Health and Type 2 Diabetes.,"CONTEXT Exposure of the small intestine to nutrients frequently leads to marked reductions in blood pressure (BP) in type 2 diabetes (T2DM). It remains unclear whether the region of the gut exposed to nutrients influences postprandial cardiovascular responses. OBJECTIVE To evaluate the cardiovascular responses to proximal and distal small intestinal glucose infusion in health and T2DM. DESIGN Double-blind, randomized, crossover design. SETTING Single center in Australia. PATIENTS 10 healthy subjects and 10 T2DM patients. INTERVENTIONS Volunteers were studied on 2 occasions, when a transnasal catheter was positioned with infusion ports opening 13 cm and 190 cm beyond the pylorus. A 30-g bolus of glucose was infused into either site and 0.9% saline into the alternate site over 60 minutes. MAIN OUTCOME MEASURES BP, heart rate (HR), and superior mesenteric artery (SMA) blood flow were measured over 180 minutes. RESULTS Systolic BP was unchanged in response to both infusions in health, but decreased in T2DM, with a greater reduction after proximal versus distal infusion (all P ≤ .01). The increment in HR did not differ between treatments in health, but was greater after distal versus proximal infusion in T2DM (P = .02). The increases in SMA blood flow were initially greater, but less sustained, with proximal versus distal infusion in health (P < .001), a pattern less evident in T2DM. CONCLUSIONS In T2DM, postprandial hypotension may be mitigated by diversion of nutrients from the proximal to the distal small intestine.",2020,"The increment in HR did not differ between treatments in health, but was greater after distal vs. proximal infusion in T2DM (P=0.02).","['10 healthy subjects and 10 T2DM patients', '30', 'Single center in Australia', 'health and type 2 diabetes']",['proximal and distal enteral glucose infusion'],"['BP, heart rate (HR) and superior mesenteric artery (SMA) blood flow', 'Systolic BP', 'cardiovascular response', 'blood pressure (BP', 'increment in HR', 'SMA blood flow']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}]","[{'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C1304890', 'cui_str': 'Enteral'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0162861', 'cui_str': 'Superior mesenteric artery structure'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}]",10.0,0.0621509,"The increment in HR did not differ between treatments in health, but was greater after distal vs. proximal infusion in T2DM (P=0.02).","[{'ForeName': 'Xiang', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Adelaide Medical School and Centre of Research Excellence in Translating Nutritional Science to Good Health, The University of Adelaide, Adelaide, Australia.'}, {'ForeName': 'Karen L', 'Initials': 'KL', 'LastName': 'Jones', 'Affiliation': 'Adelaide Medical School and Centre of Research Excellence in Translating Nutritional Science to Good Health, The University of Adelaide, Adelaide, Australia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Horowitz', 'Affiliation': 'Adelaide Medical School and Centre of Research Excellence in Translating Nutritional Science to Good Health, The University of Adelaide, Adelaide, Australia.'}, {'ForeName': 'Christopher K', 'Initials': 'CK', 'LastName': 'Rayner', 'Affiliation': 'Adelaide Medical School and Centre of Research Excellence in Translating Nutritional Science to Good Health, The University of Adelaide, Adelaide, Australia.'}, {'ForeName': 'Tongzhi', 'Initials': 'T', 'LastName': 'Wu', 'Affiliation': 'Adelaide Medical School and Centre of Research Excellence in Translating Nutritional Science to Good Health, The University of Adelaide, Adelaide, Australia.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgaa341'] 1604,32498373,High-Intensity Training Reduces CVD Risk Factors among Rotating Shift Workers: An Eight-Week Intervention in Industry.,"Rotating shift work is associated with risk factors for cardiovascular disease (CVD). We have studied the effect of 17 min high-intensity training three times a week over eight weeks on CVD risk factors among shift workers. Sixty-five shift workers from two plants were recruited. They were all deemed healthy at the initial health screening and in 100% work. From plant A, 42 workers, and plant B, 23 workers participated. After the intervention, 56 workers were retested. The intervention group consisted of 19 participants from plant A who had participated in at least 10 sessions. Twenty workers from plant B and 17 workers from plant A that not had taken part in the training were included in the control group. All workers reported physical activity (PA) by questionnaires before and after the training intervention. We measured blood pressure, heart rate, lipids, glycated hemoglobin (HbA1c), and C-reactive protein (CRP) and arterial stiffness. Maximal oxygen uptake (V̇O 2max ) was assessed by bicycle ergometry. The intervention group favorably differed significantly from the control group in improvement of systolic and diastolic blood pressure and glycated hemoglobin (HbA1c). Short training sessions with 4 min of high-intensity PA, three times a week, for eight weeks among rotating shift workers reduced some CVD risk factors. PA interventions in occupational settings may thus decrease coronary heart disease and stroke incidences in this vulnerable group of workers.",2020,The intervention group favorably differed significantly from the control group in improvement of systolic and diastolic blood pressure and glycated hemoglobin (HbA1c).,"['Rotating Shift Workers', '19 participants from plant A who had participated in at least 10 sessions', 'Sixty-five shift workers from two plants were recruited', 'From plant A, 42 workers, and plant B, 23 workers participated', 'Twenty workers from plant B and 17 workers from plant A that not had taken part in the training were included in the control group']","['High-Intensity Training', 'PA interventions']","['CVD Risk Factors', 'Maximal oxygen uptake (V̇O 2max ', 'CVD risk factors', 'blood pressure, heart rate, lipids, glycated hemoglobin (HbA1c), and C-reactive protein (CRP) and arterial stiffness', 'coronary heart disease and stroke incidences', 'physical activity (PA', 'systolic and diastolic blood pressure and glycated hemoglobin (HbA1c']","[{'cui': 'C0555009', 'cui_str': 'Rotating shift worker'}, {'cui': 'C0032098', 'cui_str': 'Kingdom Viridiplantae'}, {'cui': 'C0450385', 'cui_str': '65'}, {'cui': 'C0425104', 'cui_str': 'Shift worker'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0599949', 'cui_str': 'Arterial stiffness'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}]",19.0,0.0220527,The intervention group favorably differed significantly from the control group in improvement of systolic and diastolic blood pressure and glycated hemoglobin (HbA1c).,"[{'ForeName': 'Asgeir', 'Initials': 'A', 'LastName': 'Mamen', 'Affiliation': 'School of Health Sciences, Kristiania University College, Box 1190, Sentrum, 0107 Oslo, Norway.'}, {'ForeName': 'Reidun', 'Initials': 'R', 'LastName': 'Øvstebø', 'Affiliation': 'The Blood Cell Research Group, Department of Medical Biochemistry, Oslo University Hospital, 0450 Ullevaal, Norway.'}, {'ForeName': 'Per Anton', 'Initials': 'PA', 'LastName': 'Sirnes', 'Affiliation': 'Østlandske Hjertesenter, 1523 Moss, Norway.'}, {'ForeName': 'Pia', 'Initials': 'P', 'LastName': 'Nielsen', 'Affiliation': 'Ringvoll BHT, 1523 Moss, Norway.'}, {'ForeName': 'Marit', 'Initials': 'M', 'LastName': 'Skogstad', 'Affiliation': 'Ringvoll BHT, 1523 Moss, Norway.'}]",International journal of environmental research and public health,['10.3390/ijerph17113943'] 1605,32500957,No evidence of a legacy effect on survival following randomization to extended hours dialysis in the ACTIVE Dialysis trial.,"AIM Extended hours haemodialysis is associated with superior survival to standard hours. However, residual confounding limits the interpretation of this observation. We aimed to determine the effect of a period of extended hours dialysis on long-term survival among participants in the ACTIVE Dialysis trial. METHODS Two-hundred maintenance haemodialysis recipients were randomized to extended hours dialysis (median 24 h/wk) or standard hours dialysis (median 12 h/wk) for 12 months. Further pre-specified observational follow up occurred at 24, 36 and 60 months. Vital status and modality of renal replacement therapy were ascertained. RESULTS Over the 5 years, 38 participants died, 30 received a renal transplant, and 6 were lost to follow up. Total weekly dialysis hours did not differ between standard and extended groups during the follow-up period (14.1 hours [95%CI 13.4-14.8] vs 14.8 hours [95%CI 14.1-15.6]; P = .16). There was no difference in all-cause mortality (hazard ratio for extended hours 0.91 [95%CI 0.48-1.72]; P = .77). Similar results were obtained after censoring participants at transplantation, and after adjusting for potential confounding variables. Subgroup analysis did not reveal differences in treatment effect by region, dialysis setting or vintage (P-interaction .51, .54, .12, respectively). CONCLUSION Twelve months of extended hours dialysis did not improve long-term survival nor affect dialysis hours after the intervention period. An urgent need remains to further define the optimal dialysis intensity across the broad range of dialysis recipients.",2020,There was no difference in all-cause mortality (hazard ratio for extended hours 0.91,"['38 participants died, 30 received a renal transplant, and 6 were lost to follow up', 'participants in the ACTIVE Dialysis trial', 'Two-hundred maintenance hemodialysis recipients']",[],"['cause mortality', 'Total weekly dialysis hours', 'long-term survival', 'survival']","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}, {'cui': 'C1302313', 'cui_str': 'Lost to follow-up'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0011945', 'cui_str': 'Dialysis'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C4040576', 'cui_str': 'Maintenance hemodialysis'}]",[],"[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0011945', 'cui_str': 'Dialysis'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",200.0,0.23794,There was no difference in all-cause mortality (hazard ratio for extended hours 0.91,"[{'ForeName': 'Brendan', 'Initials': 'B', 'LastName': 'Smyth', 'Affiliation': 'Renal and Metabolic Division, The George Institute for Global Health and University of New South Wales, Sydney, New South Wales, Australia.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Zuo', 'Affiliation': ""Department of Nephrology, Peking University People's Hospital, Beijing, China.""}, {'ForeName': 'Nicholas A', 'Initials': 'NA', 'LastName': 'Gray', 'Affiliation': 'Renal Department, Sunshine Coast University Hospital, Birtinya, Queensland, Australia.'}, {'ForeName': 'Christopher T', 'Initials': 'CT', 'LastName': 'Chan', 'Affiliation': 'Department of Medicine, University Health Network, Toronto, Ontario, Canada.'}, {'ForeName': 'Janak R', 'Initials': 'JR', 'LastName': 'de Zoysa', 'Affiliation': 'Renal Services, North Shore Hospital, Auckland, New Zealand.'}, {'ForeName': 'Daqing', 'Initials': 'D', 'LastName': 'Hong', 'Affiliation': ""Renal Department, Sichuan Provincial People's Hospital, Chengdu, China.""}, {'ForeName': 'Kris', 'Initials': 'K', 'LastName': 'Rogers', 'Affiliation': 'Renal and Metabolic Division, The George Institute for Global Health and University of New South Wales, Sydney, New South Wales, Australia.'}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'School of Medicine, University of Electronic Science and Technology of China Medical School, Chengdu, China.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Cass', 'Affiliation': 'Menzies School of Health Research, Charles Darwin University, Darwin, North Territory, Australia.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Gallagher', 'Affiliation': 'Renal and Metabolic Division, The George Institute for Global Health and University of New South Wales, Sydney, New South Wales, Australia.'}, {'ForeName': 'Vlado', 'Initials': 'V', 'LastName': 'Perkovic', 'Affiliation': 'Renal and Metabolic Division, The George Institute for Global Health and University of New South Wales, Sydney, New South Wales, Australia.'}, {'ForeName': 'Meg', 'Initials': 'M', 'LastName': 'Jardine', 'Affiliation': 'Renal and Metabolic Division, The George Institute for Global Health and University of New South Wales, Sydney, New South Wales, Australia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Nephrology (Carlton, Vic.)",['10.1111/nep.13737'] 1606,32497783,Study protocol: Using peer support to aid in prevention and treatment in prediabetes (UPSTART).,"BACKGROUND There is an urgent need to develop and evaluate effective and scalable interventions to prevent or delay the onset of type 2 diabetes mellitus (T2DM). METHODS In this randomized controlled pragmatic trial, 296 adults with prediabetes will be randomized to either a peer support arm or enhanced usual care. Participants in the peer support arm meet face-to-face initially with a trained peer coach who also is a patient at the same health center to receive information on locally available wellness and diabetes prevention programs, discuss behavioral goals related to diabetes prevention, and develop an action plan for the next week to meet their goals. Over six months, peer coaches call their assigned participants weekly to provide support for weekly action steps. In the final 6 months, coaches call participants at least once monthly. Participants in the enhanced usual care arm receive information on local resources and periodic updates on available diabetes prevention programs and resources. Changes in A1c, weight, waist circumference and other patient-centered outcomes and mediators and moderators of intervention effects will be assessed. RESULTS At least 296 participants and approximately 75 peer supporters will be enrolled. DISCUSSION Despite evidence that healthy lifestyle interventions can improve health behaviors and reduce risk for T2DM, engagement in recommended behavior change is low. This is especially true among racial and ethnic minority and low-income adults. Regular outreach and ongoing support from a peer coach may help participants to initiate and sustain healthy behavior changes to reduce their risk of diabetes. TRIAL REGISTRATION The ClinicalTrials.gov registration number is NCT03689530.",2020,"Changes in A1c, weight, waist circumference and other patient-centered outcomes and mediators and moderators of intervention effects will be assessed. ","['296 adults with prediabetes', 'At least 296 participants and approximately 75 peer supporters will be enrolled']","['peer support arm or enhanced usual care', 'peer support arm meet face-to-face initially with a trained peer coach who also is a patient at the same health center to receive information on locally available wellness and diabetes prevention programs, discuss behavioral goals related to diabetes prevention, and develop an action plan']","['Changes in A1c, weight, waist circumference', 'health behaviors']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0271650', 'cui_str': 'Impaired glucose tolerance'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}]","[{'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0557773', 'cui_str': 'Coach'}, {'cui': 'C1278569', 'cui_str': 'WAS A'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0475309', 'cui_str': 'Health center'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C1273866', 'cui_str': 'Action plan (community)'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C4521595', 'cui_str': 'US Military enlisted E3'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",296.0,0.0609549,"Changes in A1c, weight, waist circumference and other patient-centered outcomes and mediators and moderators of intervention effects will be assessed. ","[{'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Heisler', 'Affiliation': 'Department of Internal Medicine, University of Michigan Medical School, Ann Arbor, MI, United States of America; VA Center for Clinical Management Research, VA Ann Arbor Healthcare System, Ann Arbor, MI, United States of America. Electronic address: mheisler@umich.edu.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Kullgren', 'Affiliation': 'Department of Internal Medicine, University of Michigan Medical School, Ann Arbor, MI, United States of America; VA Center for Clinical Management Research, VA Ann Arbor Healthcare System, Ann Arbor, MI, United States of America; Department of Health Management and Policy, University of Michigan School of Public Health, Ann Arbor, MI, United States of America; University of Michigan Institute for Healthcare Policy and Innovation, Ann Arbor, MI, United States of America. Electronic address: jkullgre@med.umich.edu.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Richardson', 'Affiliation': 'Department of Family Medicine, University of Michigan Medical School, Ann Arbor, MI, United States of America. Electronic address: caroli@umich.edu.'}, {'ForeName': 'Shelley', 'Initials': 'S', 'LastName': 'Stoll', 'Affiliation': 'Department of Internal Medicine, University of Michigan Medical School, Ann Arbor, MI, United States of America. Electronic address: scstoll@umich.edu.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Alvarado Nieves', 'Affiliation': 'University of Michigan, Department of Internal Medicine- Metabolism, Endocrinology and Diabetes, United States of America. Electronic address: alvaradc@med.umich.edu.'}, {'ForeName': 'Deanne', 'Initials': 'D', 'LastName': 'Wiley', 'Affiliation': 'Kaiser Permanente Northern California, United States of America. Electronic address: deanne.wiley@kp.org.'}, {'ForeName': 'Tali', 'Initials': 'T', 'LastName': 'Sedgwick', 'Affiliation': 'Kaiser Permanente Northern California Division of Research, United States of America. Electronic address: Tali.S.Sedgwick@kp.org.'}, {'ForeName': 'Alyce', 'Initials': 'A', 'LastName': 'Adams', 'Affiliation': 'Kaiser Permanente Northern California, United States of America. Electronic address: Alyce.S.Adams@kp.org.'}, {'ForeName': 'Monique', 'Initials': 'M', 'LastName': 'Hedderson', 'Affiliation': 'Kaiser Permanente Northern California, United States of America. Electronic address: Monique.m.hedderson@kp.org.'}, {'ForeName': 'Eileen', 'Initials': 'E', 'LastName': 'Kim', 'Affiliation': 'The Permanente Medical Group (Kaiser Permanente, Northern California), United States of America. Electronic address: Eileen.Kim@kp.org.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Rao', 'Affiliation': 'The Permanente Medical Group (Kaiser Permanente, Northern California), United States of America. Electronic address: megan.rao@kp.org.'}, {'ForeName': 'Julie A', 'Initials': 'JA', 'LastName': 'Schmittdiel', 'Affiliation': 'Kaiser Permanente Northern California Division of Research, United States of America. Electronic address: Julie.A.Schmittdiel@kp.org.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106048'] 1607,32502445,"Quality of life in patients with cervical cancer after open versus minimally invasive radical hysterectomy (LACC): a secondary outcome of a multicentre, randomised, open-label, phase 3, non-inferiority trial.","BACKGROUND In the phase 3 LACC trial and a subsequent population-level review, minimally invasive radical hysterectomy was shown to be associated with worse disease-free survival and higher recurrence rates than was open radical hysterectomy in patients with early stage cervical cancer. Here, we report the results of a secondary endpoint, quality of life, of the LACC trial. METHODS The LACC trial was a randomised, open-label, phase 3, non-inferiority trial done in 33 centres worldwide. Eligible participants were women aged 18 years or older with International Federation of Gynaecology and Obstetrics (FIGO) stage IA1 with lymphovascular space invasion, IA2, or IB1 adenocarcinoma, squamous cell carcinoma, or adenosquamous carcinoma of the cervix, with an Eastern Cooperative Oncology Group performance status of 0 or 1, who were scheduled to have a type 2 or 3 radical hysterectomy. Participants were randomly assigned (1:1) to receive open or minimally invasive radical hysterectomy. Randomisation was done centrally using a computerised minimisation program, stratified by centre, disease stage according to FIGO guidelines, and age. Neither participants nor investigators were masked to treatment allocation. The primary endpoint of the LACC trial was disease-free survival at 4·5 years, and quality of life was a secondary endpoint. Eligible patients completed validated quality-of-life and symptom assessments (12-item Short Form Health Survey [SF-12], Functional Assessment of Cancer Therapy-Cervical [FACT-Cx], EuroQoL-5D [EQ-5D], and MD Anderson Symptom Inventory [MDASI]) before surgery and at 1 and 6 weeks and 3 and 6 months after surgery (FACT-Cx was also completed at additional timepoints up to 54 months after surgery). Differences in quality of life over time between treatment groups were assessed in the modified intention-to-treat population, which included all patients who had surgery and completed at least one baseline (pretreatment) and one follow-up (at any timepoint after surgery) questionnaire, using generalised estimating equations. The LACC trial is registered with ClinicalTrials.gov, NCT00614211. FINDINGS Between Jan 31, 2008, and June 22, 2017, 631 patients were enrolled; 312 assigned to the open surgery group and 319 assigned to the minimally invasive surgery group. 496 (79%) of 631 patients had surgery completed at least one baseline and one follow-up quality-of-life survey and were included in the modified intention-to-treat analysis (244 [78%] of 312 patients in the open surgery group and 252 [79%] of 319 participants in the minimally invasive surgery group). Median follow-up was 3·0 years (IQR 1·7-4·5). At baseline, no differences in the mean FACT-Cx total score were identified between the open surgery (129·3 [SD 18·8]) and minimally invasive surgery groups (129·8 [19·8]). No differences in mean FACT-Cx total scores were identified between the groups 6 weeks after surgery (128·7 [SD 19·9] in the open surgery group vs 130·0 [19·8] in the minimally invasive surgery group) or 3 months after surgery (132·0 [21·7] vs 133·0 [22·1]). INTERPRETATION Since recurrence rates are higher and disease-free survival is lower for minimally invasive radical hysterectomy than for open surgery, and postoperative quality of life is similar between the treatment groups, gynaecological oncologists should recommend open radical hysterectomy for patients with early stage cervical cancer. FUNDING MD Anderson Cancer Center and Medtronic.",2020,"No differences in mean FACT-Cx total scores were identified between the groups 6 weeks after surgery (128·7 [SD 19·9] in the open surgery group vs 130·0 [19·8] in the minimally invasive surgery group) or 3 months after surgery (132·0 [21·7] vs 133·0 [22·1]). ","['patients with early stage cervical cancer', '496 (79%) of 631 patients had surgery completed at least one baseline and one follow-up quality-of-life survey and were included in the modified intention-to-treat analysis (244 [78%] of 312 patients in the open surgery group and 252 [79%] of 319 participants in the minimally invasive surgery group', 'patients with cervical cancer after', '631 patients were enrolled; 312 assigned to the open surgery group and 319 assigned to the minimally invasive surgery group', '33 centres worldwide', 'Eligible participants were women aged 18 years or older with International Federation of Gynaecology and Obstetrics (FIGO) stage IA1 with lymphovascular space invasion, IA2, or IB1 adenocarcinoma, squamous cell carcinoma, or adenosquamous carcinoma of the cervix, with an Eastern Cooperative Oncology Group performance status of 0 or 1, who were scheduled to have a type 2 or 3 radical hysterectomy', 'Between Jan 31, 2008, and June 22, 2017']","['open versus minimally invasive radical hysterectomy (LACC', 'radical hysterectomy', 'open or minimally invasive radical hysterectomy']","['quality of life', 'validated quality-of-life and symptom assessments (12-item Short Form Health Survey [SF-12], Functional Assessment of Cancer Therapy-Cervical', 'mean FACT-Cx total scores', 'postoperative quality of life', 'Quality of life', 'disease-free survival at 4·5 years, and quality of life', 'mean FACT-Cx total score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}, {'cui': 'C4517660', 'cui_str': '244'}, {'cui': 'C4517706', 'cui_str': '312'}, {'cui': 'C0348025', 'cui_str': 'Open approach'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0282624', 'cui_str': 'Procedures, Minimally Invasive Surgical'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0018417', 'cui_str': 'Gynecology'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C0458828', 'cui_str': 'Stage 1A1'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}, {'cui': 'C1269955', 'cui_str': 'Tumour invasion'}, {'cui': 'C0001418', 'cui_str': 'Adenocarcinoma'}, {'cui': 'C0007137', 'cui_str': 'Squamous cell carcinoma'}, {'cui': 'C0346202', 'cui_str': 'Adenosquamous carcinoma of cervix'}, {'cui': 'C1520224', 'cui_str': 'ECOG performance status'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C2987682', 'cui_str': 'Radical hysterectomy'}]","[{'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C2987682', 'cui_str': 'Radical hysterectomy'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C3494437', 'cui_str': 'Symptom Assessment'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0439234', 'cui_str': 'year'}]",631.0,0.221146,"No differences in mean FACT-Cx total scores were identified between the groups 6 weeks after surgery (128·7 [SD 19·9] in the open surgery group vs 130·0 [19·8] in the minimally invasive surgery group) or 3 months after surgery (132·0 [21·7] vs 133·0 [22·1]). ","[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Frumovitz', 'Affiliation': 'Department of Gynecologic Oncology and Reproductive Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX, USA. Electronic address: mfrumovitz@mdanderson.org.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Obermair', 'Affiliation': 'Queensland Centre for Gynaecological Cancer Research, The University of Queensland, Brisbane, QLD, Australia.'}, {'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Coleman', 'Affiliation': 'Department of Gynecologic Oncology and Reproductive Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Rene', 'Initials': 'R', 'LastName': 'Pareja', 'Affiliation': 'Instituto Nacional de Cancerología, Bogotá, Colombia; Clínica de Oncología Astorga, Medellín, Colombia.'}, {'ForeName': 'Aldo', 'Initials': 'A', 'LastName': 'Lopez', 'Affiliation': 'Instituto Nacional de Enfermedades Neoplásicas, Lima, Peru.'}, {'ForeName': 'Reitan', 'Initials': 'R', 'LastName': 'Ribero', 'Affiliation': 'Erasto Gaertner Hospital, Curitiba, Brazil.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Isla', 'Affiliation': 'Instituto Nacional de Cancerología, Mexico City, Mexico.'}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Rendon', 'Affiliation': 'Instituto de Cancerologia-Las Americas, Medellín, Colombia.'}, {'ForeName': 'Marcus Q', 'Initials': 'MQ', 'LastName': 'Bernardini', 'Affiliation': 'Princess Margaret Cancer Center, Toronto, ON, Canada.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Buda', 'Affiliation': 'San Gerardo Hospital, Monza, Italy.'}, {'ForeName': 'Renato', 'Initials': 'R', 'LastName': 'Moretti-Marquez', 'Affiliation': 'Hospital Israelita Albert Einstein, Centro de Oncologia e Hematologia, São Paulo, Brazil.'}, {'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Zevallos', 'Affiliation': 'Instituto Nacional de Enfermedades Neoplásicas, Lima, Peru.'}, {'ForeName': 'Marcelo A', 'Initials': 'MA', 'LastName': 'Vieira', 'Affiliation': 'Barretos Cancer Hospital, São Paulo, Brazil.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Zhu', 'Affiliation': 'Institute of Cancer Research and Basic Medical Sciences of Chinese Academy of Sciences, Cancer Hospital of University of Chinese Academy of Sciences, Hangzhou, China.'}, {'ForeName': 'Russell P', 'Initials': 'RP', 'LastName': 'Land', 'Affiliation': 'School of Medicine, The University of Queensland, Brisbane, QLD, Australia.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Nicklin', 'Affiliation': 'School of Medicine, The University of Queensland, Brisbane, QLD, Australia.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Asher', 'Affiliation': 'National Health and Medical Research Council Clinical Trials Centre, University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Kristy P', 'Initials': 'KP', 'LastName': 'Robledo', 'Affiliation': 'National Health and Medical Research Council Clinical Trials Centre, University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Val', 'Initials': 'V', 'LastName': 'Gebski', 'Affiliation': 'National Health and Medical Research Council Clinical Trials Centre, University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Pedro T', 'Initials': 'PT', 'LastName': 'Ramirez', 'Affiliation': 'Department of Gynecologic Oncology and Reproductive Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}]",The Lancet. Oncology,['10.1016/S1470-2045(20)30081-4'] 1608,32503620,Adding Colchicine to the Antiretroviral Medication - Lopinavir/Ritonavir (Kaletra) in Hospitalized Patients with Non-Severe Covid-19 Pneumonia: A Structured Summary of a Study Protocol for a Randomized Controlled Trial.,"OBJECTIVES Colchicine is a well-known drug, which has been used for years to treat a wide range of rheumatic and inflammatory disorders. It helps break the cycle of inflammation through diverse mechanisms including reducing Intereukin-6, Interleukin-8, Tumour Necrosis Factor-alpha besides controlling oxidative stress pathways which all are important and pathologic components in the clinical course and outcome of patients infected with COVID-19. This study aims to assess the anti-inflammatory effects of colchicine in non-severe hospitalized COVID-19 patients. TRIAL DESIGN Prospective, randomized (1:1 ratio), double blind study with parallel group design. PARTICIPANTS Hospitalized patients with positive nasopharyngeal swab for COVID-19 infection (RT -PCR) and lung Computed tomography scan involvement compatible with COVID-19 pneumonia. The patients are not severely hypoxic, do not need intubation or invasive oxygenation. EXCLUSION CRITERIA known hypersensitivity to colchicine; known hepatic failure; estimated glomerular filtration rate (eGFR)<30 ml/min/1.73m 2 (by the CKD-EPI Creatinine Equation for Glomerular Filtration Rate (GFR) which estimates GFR based on serum creatinine. ; kidney transplant recipients, using Digoxin, QTc >450 msec. Participants will be recruited from inpatients at Labbafinejad Meidcal Center , Tehran, Iran. INTERVENTION AND COMPARATOR Eligible enrolled patients will be randomized into two groups. Group A will receive the antiretroviral Lopinavir/Ritonavir (Kaletra) while group B will receive Lopinavir/Ritonavir (Kaletra) + Colchicine 1.5 mg loading then 0.5 mg twice daily orally. All patients in both groups will receive the same amounts of essential minerals, vitamins as antioxidants, and antibiotics. Patients of both groups will be treated under optimal treatment based on the CDC and WHO guidelines and national consensus proposed in Iran including the same dosages of Lopinavir/Ritonavir, antibiotics, trace elements and antioxidants while only in group-B patients Colchicine will be added on top of this protocol. MAIN OUTCOMES Primary: Time for clinical improvement and lung CT score changes 14 days after treatment. Secondary: 14 days after treatment - C-Reactive Protein test x Neutrophil to Lymphocyte Ratio , Interleukin-6, malondialdehyde (MDA) levels reduction - Percentage of patients who require supplemental Oxygen - Mean hospital stay length RANDOMISATION: Patients will be allocated to each group (ratio 1:1) by using an online randomization tool: http://www.graphpad.com/quickcalcs/index.cfm BLINDING (MASKING): This will be a double-blind study in which participants and those assessing the final outcomes will be blinded to group assignment. NUMBERS TO BE RANDOMISED (SAMPLE SIZE) Regarding the pandemic crisis and our center capacity to hospitalize confirmed COVID-19 patients, a total of 80 patients was found to be logical to be randomized into two groups of 40- patients. TRIAL STATUS Recruitment is ongoing. Recruitment began on 20/03/2020 and the date by which the recruitment is anticipated to be completed is 30/05/2020. TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT04360980, registered 24/04/2020. FULL PROTOCOL The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.",2020,"Secondary: 14 days after treatment - C-Reactive Protein test x Neutrophil to Lymphocyte Ratio , Interleukin-6, malondialdehyde (MDA) levels","[' kidney transplant recipients, using Digoxin, QTc >450 msec', 'Hospitalized Patients with Non-Severe Covid-19 Pneumonia', 'Hospitalized patients with positive nasopharyngeal swab for COVID-19 infection (RT -PCR) and lung Computed tomography scan involvement compatible with COVID-19 pneumonia', '80 patients was found to be logical to be randomized into two groups of 40- patients', 'non-severe hospitalized COVID-19 patients', 'Participants will be recruited from inpatients at Labbafinejad Meidcal Center , Tehran, Iran', 'patients who require supplemental Oxygen - Mean hospital stay length RANDOMISATION']","['Antiretroviral Medication - Lopinavir/Ritonavir (Kaletra', 'Colchicine', 'essential minerals, vitamins as antioxidants, and antibiotics', 'colchicine', 'Lopinavir/Ritonavir, antibiotics, trace elements and antioxidants while only in group-B patients Colchicine', 'antiretroviral Lopinavir/Ritonavir (Kaletra) while group B will receive Lopinavir/Ritonavir (Kaletra) + Colchicine']","['glomerular filtration rate', 'Reactive Protein test x Neutrophil to Lymphocyte Ratio , Interleukin-6, malondialdehyde (MDA) levels', 'clinical improvement and lung CT score changes']","[{'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}, {'cui': 'C0012265', 'cui_str': 'Digoxin'}, {'cui': 'C0860814', 'cui_str': 'QTc'}, {'cui': 'C3844104', 'cui_str': '450'}, {'cui': 'C0439223', 'cui_str': 'ms'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0444192', 'cui_str': 'Nasopharyngeal swab'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0599161', 'cui_str': 'Polymerase Chain Reaction, Reverse Transcriptase'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0332290', 'cui_str': 'Consistent with'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C1444754', 'cui_str': 'Length'}]","[{'cui': 'C0599685', 'cui_str': 'Antiretroviral-containing product'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0939237', 'cui_str': 'lopinavir and ritonavir'}, {'cui': 'C0939357', 'cui_str': 'Kaletra'}, {'cui': 'C0009262', 'cui_str': 'Colchicine'}, {'cui': 'C0205224', 'cui_str': 'Essential'}, {'cui': 'C0006660', 'cui_str': 'Physiologic Calcification'}, {'cui': 'C0042890', 'cui_str': 'Vitamin'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0040577', 'cui_str': 'Trace element'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0205332', 'cui_str': 'Reactive'}, {'cui': 'C0202202', 'cui_str': 'Protein measurement'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear leukocyte'}, {'cui': 'C0024264', 'cui_str': 'Lymphocyte'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0412611', 'cui_str': 'CT of lungs'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",80.0,0.454787,"Secondary: 14 days after treatment - C-Reactive Protein test x Neutrophil to Lymphocyte Ratio , Interleukin-6, malondialdehyde (MDA) levels","[{'ForeName': 'Nooshin', 'Initials': 'N', 'LastName': 'Dalili', 'Affiliation': 'Department of Nephrology, Shahid Labbafinejad Medical Center, Shahid Beheshti University of Medical Sciences, Boostan 9th St., Pasdaran Av, Tehran, Iran. drn.dalili@sbmu.ac.ir.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Kashefizadeh', 'Affiliation': 'Department of Pulmonology, Shahid Labbafinejad Medical Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohsen', 'Initials': 'M', 'LastName': 'Nafar', 'Affiliation': 'Department of Nephrology, Shahid Labbafinejad Medical Center, Shahid Beheshti University of Medical Sciences, Boostan 9th St., Pasdaran Av, Tehran, Iran.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Poorrezagholi', 'Affiliation': 'Department of Nephrology, Shahid Labbafinejad Medical Center, Shahid Beheshti University of Medical Sciences, Boostan 9th St., Pasdaran Av, Tehran, Iran.'}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Firouzan', 'Affiliation': 'Department of Nephrology, Shahid Labbafinejad Medical Center, Shahid Beheshti University of Medical Sciences, Boostan 9th St., Pasdaran Av, Tehran, Iran.'}, {'ForeName': 'Fariba', 'Initials': 'F', 'LastName': 'Samadian', 'Affiliation': 'Department of Nephrology, Shahid Labbafinejad Medical Center, Shahid Beheshti University of Medical Sciences, Boostan 9th St., Pasdaran Av, Tehran, Iran.'}, {'ForeName': 'Shiva', 'Initials': 'S', 'LastName': 'Samavat', 'Affiliation': 'Department of Nephrology, Shahid Labbafinejad Medical Center, Shahid Beheshti University of Medical Sciences, Boostan 9th St., Pasdaran Av, Tehran, Iran.'}, {'ForeName': 'Shadi', 'Initials': 'S', 'LastName': 'Ziaie', 'Affiliation': 'Clinical Pharmacy Department, Faculty of Pharmacy, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Somayeh', 'Initials': 'S', 'LastName': 'Fatemizadeh', 'Affiliation': 'Department of Internal Medicine, Shahid Labbafinejad Medical Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}]",Trials,['10.1186/s13063-020-04455-3'] 1609,32504284,"N083E (Alliance): long-term outcomes of patients treated in a pilot phase II study of docetaxel, carboplatin, trastuzumab, and lapatinib as adjuvant therapy for early-stage HER2-positive breast cancer.","BACKGROUND The addition of lapatinib (L) to trastuzumab (T) was previously found to be synergistic in preclinical models and in the neoadjuvant setting. Prior to the results of the ALTTO trial, this study assessed the safety and feasibility of adding L to the standard adjuvant docetaxel, carboplatin, and trastuzumab (TCH) regimen in early-stage HER2-positive breast cancer (HER2+ BC). METHODS In this single-arm, 2-stage, phase II study, patients with stages I-III HER2+ BC received TCH plus L at 1000 mg daily for a total of 12 months. The primary endpoint was the safety and tolerability, including the rate of diarrhea. Secondary endpoints included adverse event (AE) profile using the NCI CTCAE v3.0 and cardiac safety. RESULTS Thirty eligible patients were enrolled. Median follow-up is 5.3 years. Diarrhea was the most common AE with 50% Grade (G)1/2 and 43% G3 diarrhea. However, it was responsive to dose reduction of L (750 mg) and institution of anti-diarrheal medications. Cardiovascular AE were infrequent and no patients experienced congestive heart failure while on treatment. CONCLUSION TCHL was a tolerable regimen at a starting L dose of 750 mg PO daily when given concurrently with chemotherapy.",2020,"Cardiovascular AE were infrequent and no patients experienced congestive heart failure while on treatment. ","['early-stage HER2-positive breast cancer (HER2+\u2009BC', 'Thirty eligible patients were enrolled', 'early-stage HER2-positive breast cancer']","['standard adjuvant docetaxel, carboplatin, and trastuzumab (TCH) regimen', 'TCH plus L', 'lapatinib (L) to trastuzumab (T', 'docetaxel, carboplatin, trastuzumab, and lapatinib as adjuvant therapy', 'N083E', 'TCHL']","['safety and tolerability', 'rate of diarrhea', 'Cardiovascular AE', 'congestive heart failure', 'Diarrhea', 'adverse event (AE) profile using the NCI CTCAE v3.0 and cardiac safety']","[{'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C1960398', 'cui_str': 'HER2-positive carcinoma of breast'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1506770', 'cui_str': 'lapatinib'}, {'cui': 'C0677850', 'cui_str': 'Adjuvant therapy'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0018802', 'cui_str': 'Congestive heart failure'}, {'cui': 'C0560007', 'cui_str': 'nCi'}, {'cui': 'C1516728', 'cui_str': 'National Cancer Institute common terminology criteria for adverse events'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}]",30.0,0.0277203,"Cardiovascular AE were infrequent and no patients experienced congestive heart failure while on treatment. ","[{'ForeName': 'Roberto A', 'Initials': 'RA', 'LastName': 'Leon-Ferre', 'Affiliation': 'Division of Medical Oncology, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Edith A', 'Initials': 'EA', 'LastName': 'Perez', 'Affiliation': 'Division of Hematology and Oncology, Mayo Clinic, 4500 San Pablo Rd, Jacksonville, FL, 32224, USA.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Hillman', 'Affiliation': 'Department of Biomedical Statistics and Informatics, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Celyne', 'Initials': 'C', 'LastName': 'Bueno', 'Affiliation': 'Department of General Oncology, MD Anderson Cancer Center Bay Area, Nassau Bay, TX, USA.'}, {'ForeName': 'Alejandra T', 'Initials': 'AT', 'LastName': 'Perez', 'Affiliation': 'Breast Cancer Centers, Memorial Cancer Institute, Hollywood, FL, USA.'}, {'ForeName': 'Beiyun', 'Initials': 'B', 'LastName': 'Chen', 'Affiliation': 'Department of Laboratory Medicine and Pathology, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Robert B', 'Initials': 'RB', 'LastName': 'Jenkins', 'Affiliation': 'Department of Laboratory Medicine and Pathology, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Donald W', 'Initials': 'DW', 'LastName': 'Northfelt', 'Affiliation': 'Division of Hematology and Oncology, Mayo Clinic, Scottsdale, AZ, USA.'}, {'ForeName': 'David B', 'Initials': 'DB', 'LastName': 'Johnson', 'Affiliation': 'Department of Hematology/Oncology, Wichita Community Clinical Oncology Program, Wichita, KS, USA.'}, {'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Carolla', 'Affiliation': 'Department of Hematology/Oncology, Cancer Research for the Ozarks, Springfield, MO, USA.'}, {'ForeName': 'Robin T', 'Initials': 'RT', 'LastName': 'Zon', 'Affiliation': 'Department of Oncology, North Indiana Cancer Research Consortium CCOP, South Bend, IN, USA.'}, {'ForeName': 'Alvaro', 'Initials': 'A', 'LastName': 'Moreno-Aspitia', 'Affiliation': 'Division of Hematology and Oncology, Mayo Clinic, 4500 San Pablo Rd, Jacksonville, FL, 32224, USA. morenoaspitia.alvaro@mayo.edu.'}]",Breast cancer research and treatment,['10.1007/s10549-020-05709-z'] 1610,32505126,Striatal activation to monetary reward is associated with alcohol reward sensitivity.,"One well-known phenotypic risk factor for the development of alcohol use disorder is sensitivity to the rewarding effects of alcohol. In the present study, we examined whether individuals who are sensitive to alcohol reward are also sensitive to nondrug rewards, thereby reflecting a broader individual difference risk factor. Specifically, we tested the hypothesis that subjective response to acute rewarding effects of alcohol would be related to neural activation during monetary reward receipt relative to loss (in the absence of alcohol). Community-recruited healthy young social drinkers (N = 58) completed four laboratory sessions in which they received alcohol (0.8 g/kg) and placebo in alternating order under double-blind conditions, providing self-report measures of subjective response to alcohol at regular intervals. At a separate visit 1-3 weeks later, they completed a reward-guessing game, the 'Doors' task, during fMRI in a drug-free state. Participants who reported greater motivation (i.e., wanting) to consume more alcohol after a single moderate dose of alcohol also exhibited greater neural activation in the bilateral ventral caudate and the nucleus accumbens during reward receipt relative to loss. Striatal activation was not related to other subjective ratings including alcohol-induced sedation, stimulation, or pleasure (i.e., feeling, liking). Our study is the first to show that measures of alcohol reward are related to neural indices of monetary reward in humans. These results support growing evidence that individual differences in responses to drug and nondrug reward are linked and together form a risk profile for drug use or abuse, particularly in young adults.",2020,"Striatal activation was not related to other subjective ratings including alcohol-induced sedation, stimulation, or pleasure (i.e., feeling, liking).","['young adults', 'Community-recruited healthy young social drinkers (N\u2009=\u200958']","['alcohol', 'placebo']","['neural activation', 'subjective ratings including alcohol-induced sedation, stimulation, or pleasure (i.e., feeling, liking']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0337676', 'cui_str': 'Social drinker'}]","[{'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0679105', 'cui_str': 'Pleasure'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}]",,0.0330504,"Striatal activation was not related to other subjective ratings including alcohol-induced sedation, stimulation, or pleasure (i.e., feeling, liking).","[{'ForeName': 'Milena', 'Initials': 'M', 'LastName': 'Radoman', 'Affiliation': 'Department of Psychiatry, University of Illinois at Chicago, 1601 W Taylor Street, Chicago, IL, 60612, USA. mradom3@uic.edu.'}, {'ForeName': 'Natania A', 'Initials': 'NA', 'LastName': 'Crane', 'Affiliation': 'Department of Psychiatry, University of Illinois at Chicago, 1601 W Taylor Street, Chicago, IL, 60612, USA.'}, {'ForeName': 'Stephanie M', 'Initials': 'SM', 'LastName': 'Gorka', 'Affiliation': 'Department of Psychiatry and Behavioral Health, Ohio State University, 1670 Upham Drive, Columbus, OH, 43205, USA.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Weafer', 'Affiliation': 'Department of Psychology, University of Kentucky, 171 Funkhouser Drive, Lexington, KY, 40506, USA.'}, {'ForeName': 'Scott A', 'Initials': 'SA', 'LastName': 'Langenecker', 'Affiliation': 'Department of Psychiatry, University of Utah, 50N Medical Drive, Salt Lake City, UT, 84132, USA.'}, {'ForeName': 'Harriet', 'Initials': 'H', 'LastName': 'de Wit', 'Affiliation': 'Department of Psychiatry and Behavioral Neuroscience, University of Chicago, 5841S Maryland Avenue, Chicago, IL, 60637, USA.'}, {'ForeName': 'K Luan', 'Initials': 'KL', 'LastName': 'Phan', 'Affiliation': 'Department of Psychiatry and Behavioral Health, Ohio State University, 1670 Upham Drive, Columbus, OH, 43205, USA.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-020-0728-6'] 1611,32506733,Methylene blue vs methyl aminolevulinate photodynamic therapy in combination with oral terbinafine in the treatment of severe dermatophytic toenail onychomycosis: Short- and long-term effects.,"BACKGROUND Photodynamic therapy (PDT) kills target microorganisms via reactive oxygen species (ROS) production. PDT seems to be a good alternative treatment option for onychomycosis. OBJECTIVE To compare the efficacy of combined therapies based on oral terbinafine (TN) plus adjunctive PDT mediated by methylene blue (MB) (TN + MB/PDT) or methyl aminolevulinate (MAL) (TN + MAL/PDT) in the treatment of onychomycosis. METHODS Twenty patients affected by severe dermatophyte onychomycosis in the nails of the big toe (>60% disease involvement of target nail) received oral TN for 12 weeks and concomitantly were randomly allocated to receive nine sessions, separated by 2-week intervals, of urea (40%) plus a PDT protocol mediated by MB (TN + MB/PDT: group I) or mediated by MAL (TN + MAL/PDT: group II). Clinical and mycological efficacy was evaluated at 16-, 40- and 52-week follow-up. RESULTS Both protocols showed a significant decrease in Onychomycosis Severity Index (OSI) scores (P < .05), from 24.2 ± 4.6 to 0.7 ± 0.6 (group I)) and from 18.5 ± 10.1 to 2.1 ± 2.0 (group II). No side effects or complications were reported in any of the combinations used. Mycological cure rates were significantly higher during the last third of the evaluated period of time, reaching 100% and 90% in group I and group II, respectively, at the 52-week follow-up. In both modalities, complete cure was achieved in 70% of the patients at the 52-week follow-up. CONCLUSIONS TN + MB/PDT and TN + MAL/PDT show similar outcomes in the treatment of toenails with severe onychomycosis. PDT is an effective method to accelerate the TN-mediated healing process.",2020,"Both protocols showed a significant decrease in Onychomycosis Severity Index (OSI) scores (p<0.05), from 24.2±4.6 to 0.7±0.6 (group I)) and from 18.5±10.1 to 2.1±2.0 (group II).","['toenails with severe onychomycosis', 'severe dermatophytic toenail onychomycosis', 'Twenty patients affected by severe dermatophyte onychomycosis in the nails of the big toe (>60% disease involvement of target nail) received oral TN for 12 weeks and concomitantly']","['PDT protocol mediated by MB (TN+MB/PDT: group I) or mediated by MAL (TN+MAL/PDT', 'Photodynamic therapy (PDT', 'TN+MB/PDT and TN+MAL/PDT', 'terbinafine', 'PDT', 'Methylene blue vs. methyl aminolevulinate photodynamic therapy', 'terbinafine (TN) plus adjunctive PDT mediated by methylene blue (MB) (TN+MB/PDT) or methyl aminolevulinate (MAL) (TN+MAL/PDT']","['Onychomycosis Severity Index (OSI) scores', 'Mycological cure rates', 'complete cure', 'Clinical and mycological efficacy', 'side effects or complications']","[{'cui': 'C0222007', 'cui_str': 'Toenails'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0040261', 'cui_str': 'Onychomycosis'}, {'cui': 'C0522476', 'cui_str': 'Patient affected'}, {'cui': 'C0011635', 'cui_str': 'Arthrodermataceae'}, {'cui': 'C0027342', 'cui_str': 'Nail plate structure'}, {'cui': 'C0018534', 'cui_str': 'Hallux structure'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0076110', 'cui_str': 'terbinafine'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0031740', 'cui_str': 'Photochemotherapy'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0025746', 'cui_str': 'Methylene blue'}, {'cui': 'C1260957', 'cui_str': 'Blue color'}, {'cui': 'C0441843', 'cui_str': 'Group I'}, {'cui': 'C1134467', 'cui_str': 'methyl 5-aminolevulinate'}, {'cui': 'C0600157', 'cui_str': 'Aminolevulinate'}, {'cui': 'C0076110', 'cui_str': 'terbinafine'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0040261', 'cui_str': 'Onychomycosis'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205467', 'cui_str': 'Mycologic'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",20.0,0.0247545,"Both protocols showed a significant decrease in Onychomycosis Severity Index (OSI) scores (p<0.05), from 24.2±4.6 to 0.7±0.6 (group I)) and from 18.5±10.1 to 2.1±2.0 (group II).","[{'ForeName': 'Enrique', 'Initials': 'E', 'LastName': 'Alberdi', 'Affiliation': 'Private clinic of Dr. Alberdi, Madrid, Spain.'}, {'ForeName': 'Clara', 'Initials': 'C', 'LastName': 'Gómez', 'Affiliation': 'Institute of Physical Chemistry Rocasolano, CSIC, Madrid, Spain.'}]",Mycoses,['10.1111/myc.13125'] 1612,32506738,Evaluation of the Effect of Maribavir on Cardiac Repolarization in Healthy Participants: Thorough QT/QTc Study.,"Maribavir is an orally bioavailable benzimidazole riboside in clinical development for treatment of cytomegalovirus infection in patients who undergo transplantation. Maribavir was evaluated in a thorough QT (TQT) study to determine any effects on cardiac repolarization. The effect of maribavir 100 and 1,200 mg oral doses on the baseline-adjusted and placebo-adjusted corrected QT (QTc) interval (delta delta QTc (ddQTc)) and other electrocardiogram (ECG) parameters was assessed in a randomized, phase I, placebo-controlled, four-period crossover study in healthy participants (men and women ages 18-50 years). Additionally, maribavir pharmacokinetics, safety, and tolerability were investigated. Moxifloxacin (400 mg) was used as a positive control to demonstrate the study's ability to detect QT prolongation. Digital 12-lead Holter ECG monitoring was performed over 22 hours following study drug administration. Individual, Fridericia's, and Bazett's QTc intervals were calculated. Of 52 randomized participants (29 ± 8.1 years old; 31 men (60%)), 50 (96%) completed the study. For both 100-mg and 1200-mg doses of maribavir, analysis of ddQTc demonstrated that the upper bound of the two-sided 90% confidence interval was below the 10-ms threshold at all time points. The concentration-effect analysis demonstrated no relationship between ddQTc and plasma concentrations of maribavir (and its metabolite). There were no clinically meaningful changes in heart rate and systolic blood pressure. The most common adverse event was dysgeusia; no serious adverse events were reported. This TQT study demonstrated that maribavir did not have impact on cardiac repolarization.",2020,There were no clinically meaningful changes in heart rate and systolic blood pressure.,"['Of 52 randomized participants (29 ± 8.1 years old; 31 [60%] males), 50 (96%) completed the study', 'Healthy Participants', 'healthy participants (males and females ages 18-50', 'transplant patients']","['baseline- and placebo-adjusted QTc interval (delta delta QTc [ddQTc]) and other electrocardiogram (ECG', 'Moxifloxacin', 'Maribavir', 'bioavailable benzimidazole riboside', 'placebo']","['Cardiac Repolarization', 'heart rate and systolic blood pressure', 'ddQTc and plasma concentrations of maribavir (and its metabolite', 'maribavir pharmacokinetics, safety, and tolerability', 'cardiac repolarization', ""Individual (QTcIb), Fridericia's (QTcF), and Bazett's (QTcB) QTc intervals""]","[{'cui': 'C4517875', 'cui_str': '8.1'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0860814', 'cui_str': 'QTc'}, {'cui': 'C0439097', 'cui_str': 'Delta'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0536495', 'cui_str': 'moxifloxacin'}, {'cui': 'C1508759', 'cui_str': 'maribavir'}, {'cui': 'C0935763', 'cui_str': 'Bioavailable'}, {'cui': 'C0005050', 'cui_str': 'Benzimidazoles'}]","[{'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C1508759', 'cui_str': 'maribavir'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0860814', 'cui_str': 'QTc'}]",52.0,0.108432,There were no clinically meaningful changes in heart rate and systolic blood pressure.,"[{'ForeName': 'Katarina', 'Initials': 'K', 'LastName': 'Ilic', 'Affiliation': 'Shire, a Takeda Company, Lexington, Massachusetts, USA.'}, {'ForeName': 'Ivy', 'Initials': 'I', 'LastName': 'Song', 'Affiliation': 'Shire, a Takeda Company, Lexington, Massachusetts, USA.'}, {'ForeName': 'Jingyang', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'Shire, a Takeda Company, Lexington, Massachusetts, USA.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Martin', 'Affiliation': 'Shire, a Takeda Company, Lexington, Massachusetts, USA.'}]",Clinical and translational science,['10.1111/cts.12814'] 1613,32507357,A randomized open label efficacy clinical trial of oral guava leaf decoction in patients with acute infectious diarrhoea.,"BACKGROUND Diarrhoea is amongst the first ten causes of death and its treatment faces an increased threat of drug resistance. Previous studies on the guava leaf decoction (GLD) revealed its suitability for use in infectious diarrhoea of unknown etiology. OBJECTIVE The objective of this trial was to establish efficacy, dose and safety of GLD prepared from the Indian Sardar variety in adults with acute infectious diarrhoea. METHODS The current trial was an open efficacy randomized 5-day, parallel group multi-arm interventional study. Amongst 137 adults (18-60 years) suffering with acute diarrhoea, 109 were included (57% females, 43% males). Three doses of GLD (6-leaf, 10-leaf and 14-leaf) were compared with controls receiving oral rehydration solution. Decrease in stool frequency and improvement in consistency were the outcomes measured. The data was analyzed using ANOVA, Tukey's post-hoc test, Kruscal-Wallis test and Chi-Square test where applicable. RESULTS The trial showed that the 14-leaf (7.4 g) decoction was the most effective. Administration of the decoction, thrice daily helped the patients regain normalcy in 72 h as opposed to 120 h in controls. Safety of the intervention was reflected by normal levels of haemoglobin, liver and kidney parameters. No adverse events were reported. CONCLUSION The 14 leaves decoction was a safe treatment for adult acute uncomplicated diarrhoea of unknown etiology. Moreover due to component synergy and divergent mechanisms of action, it could possibly combat the generation of drug resistance and destruction of gut microbiota. Hence GLD has the potential for development as a first line treatment for diarrhoea. TRIAL REGISTRATION Trial was registered with Clinical Trials Registry - India (CTRI registration number: CTRI/2016/07/007095). The trial was retrospectively registered.",2020,"No adverse events were reported. ","['137 adults (18-60 years) suffering with acute diarrhoea, 109 were included (57% females, 43% males', 'adults with acute infectious diarrhoea', 'patients with acute infectious diarrhoea']","['GLD', 'guava leaf decoction (GLD', 'decoction', 'oral guava leaf decoction']","['adverse events', 'normal levels of haemoglobin, liver and kidney parameters', 'stool frequency']","[{'cui': 'C4517569', 'cui_str': '137'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0740441', 'cui_str': 'Acute diarrhea'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0013369', 'cui_str': 'Infectious diarrheal disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0453279', 'cui_str': 'Guava'}, {'cui': 'C0242724', 'cui_str': 'Leaves'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}]",137.0,0.145841,"No adverse events were reported. ","[{'ForeName': 'Tannaz', 'Initials': 'T', 'LastName': 'Birdi', 'Affiliation': 'Foundation for Medical Research, 84-A, R. G. Thadani Marg, Worli, Mumbai-400018, India. Electronic address: fmrmum@gmail.com.'}, {'ForeName': 'G Geetha', 'Initials': 'GG', 'LastName': 'Krishnan', 'Affiliation': 'Medanta-The Medicity, Sector-38, Gurugram, Haryana-122001, India.'}, {'ForeName': 'Sushila', 'Initials': 'S', 'LastName': 'Kataria', 'Affiliation': 'Medanta-The Medicity, Sector-38, Gurugram, Haryana-122001, India.'}, {'ForeName': 'Manasi', 'Initials': 'M', 'LastName': 'Gholkar', 'Affiliation': 'Foundation for Medical Research, 84-A, R. G. Thadani Marg, Worli, Mumbai-400018, India.'}, {'ForeName': 'Poonam', 'Initials': 'P', 'LastName': 'Daswani', 'Affiliation': 'Foundation for Medical Research, 84-A, R. G. Thadani Marg, Worli, Mumbai-400018, India.'}]",Journal of Ayurveda and integrative medicine,['10.1016/j.jaim.2020.04.001'] 1614,32498113,"Pharmacokinetics, Safety, and Bioequivalence of Two Empagliflozin Formulations after Single Oral Administration under Fasting and Fed Conditions in Healthy Chinese Subjects: An Open-label Randomized Single-dose Two-sequence, Two-treatment, Two-period Crossover Study.","OBJECTIVES To evaluate the pharmacokinetic properties and safety of empagliflozin, and the bioequivalence of test formulation empagliflozin tablet compared with the brand-name drug Jardiance (reference formulation) after single oral administration under fasting and fed conditions in healthy Chinese subjects. METHODS An open-label randomized single-dose two-sequence, two-treatment, two-period crossover study was conducted in healthy Chinese subjects, with 30 subjects under fasting condition and another 30 subjects under fed condition. Under each condition, subjects received a single oral administration of either the test or reference empagliflozin formulation, and then they received a single oral dose of the other formulation after a 7-day washout period. RESULTS A total of 29 subjects under each condition completed the study. The maximum plasma drug concentration, the area under the plasma concentration-time curve (AUC) from 0 to t (AUC 0-t ), and the AUC from 0 to infinity (AUC 0-∞ ) of test formulation and reference formulation was 186.90 ± 47.21 and 190.60 ± 40.94 ng/ml, 1303.04 ± 234.28 and 1267.78 ± 217.07 ng·hour/ml, and 1328.08 ± 243.84 and 1293.22 ± 224.82 ng·hour/ml under fasting condition, and 151.55 ± 23.86 and 154.08 ± 30.40 ng/ml, 1215.65 ± 197.62 and 1199.26 ± 186.23 ng·hour/ml, and 1241.76 ± 202.47 and 1225.54 ± 192.10 ng·hour/ml under fed condition, respectively. CONCLUSIONS The two formulations of empagliflozin were bioequivalent, and both were generally well tolerated under fasting and fed conditions.",2020,"The maximum plasma concentration (C max ), the area under the plasma concentration-time curve (AUC) from 0 to t (AUC 0-t ), and the AUC from 0 to infinity (AUC 0-∞ ) of test formulation and reference formulation was 186.90 ± 47.21 and 190.60 ± 40.94 ng/mL, 1303.04 ± 234.28 and 1267.78 ± 217.07 ng·h/mL, and 1328.08 ± 243.84 and 1293.22 ± 224.82 ng·h/mL under fasting condition, and 151.55 ± 23.86 and 154.08 ± 30.40 ng/mL, 1215.65 ± 197.62 and 1199.26 ± 186.23 ng·h/mL, and 1241.76 ± 202.47 and 1225.54 ± 192.10 ng·h/mL under fed condition, respectively. ","['29 subjects under each condition completed the study', 'healthy Chinese subjects', 'healthy Chinese subjects, with 30 subjects under fasting condition and another 30 subjects under fed condition']","['empagliflozin formulations', 'empagliflozin formulation', 'empagliflozin']","['maximum plasma concentration (C max ), the area under the plasma concentration-time curve (AUC', 'Pharmacokinetics, safety, and bioequivalence']","[{'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0204695', 'cui_str': 'Feeding patient'}]","[{'cui': 'C3490348', 'cui_str': 'empagliflozin'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}]","[{'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0039789', 'cui_str': 'Equivalencies, Therapeutic'}]",30.0,0.0489666,"The maximum plasma concentration (C max ), the area under the plasma concentration-time curve (AUC) from 0 to t (AUC 0-t ), and the AUC from 0 to infinity (AUC 0-∞ ) of test formulation and reference formulation was 186.90 ± 47.21 and 190.60 ± 40.94 ng/mL, 1303.04 ± 234.28 and 1267.78 ± 217.07 ng·h/mL, and 1328.08 ± 243.84 and 1293.22 ± 224.82 ng·h/mL under fasting condition, and 151.55 ± 23.86 and 154.08 ± 30.40 ng/mL, 1215.65 ± 197.62 and 1199.26 ± 186.23 ng·h/mL, and 1241.76 ± 202.47 and 1225.54 ± 192.10 ng·h/mL under fed condition, respectively. ","[{'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Chen', 'Affiliation': 'Department of Clinical Pharmacology, Aerospace Center Hospital, Beijing, China.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Zhang', 'Affiliation': 'Department of Clinical Pharmacology, Aerospace Center Hospital, Beijing, China.'}, {'ForeName': 'Aihua', 'Initials': 'A', 'LastName': 'Du', 'Affiliation': 'Department of Clinical Pharmacology, Aerospace Center Hospital, Beijing, China.'}, {'ForeName': 'Yanan', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Clinical Pharmacology, Aerospace Center Hospital, Beijing, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Clinical Pharmacology, Aerospace Center Hospital, Beijing, China.'}, {'ForeName': 'Lina', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Department of Clinical Pharmacology, Aerospace Center Hospital, Beijing, China.'}, {'ForeName': 'Siqi', 'Initials': 'S', 'LastName': 'Zang', 'Affiliation': 'Department of Clinical Pharmacology, Aerospace Center Hospital, Beijing, China.'}, {'ForeName': 'Xiaona', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Department of Clinical Pharmacology, Aerospace Center Hospital, Beijing, China.'}, {'ForeName': 'Zejuan', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Department of Clinical Pharmacology, Aerospace Center Hospital, Beijing, China.'}, {'ForeName': 'Haiqing', 'Initials': 'H', 'LastName': 'Zhen', 'Affiliation': 'GCP Office, Aerospace Center Hospital, Beijing, China.'}, {'ForeName': 'Yujing', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Beijing Sun-Novo Pharmaceutical Research Co., Ltd., Beijing, China.'}, {'ForeName': 'Shuya', 'Initials': 'S', 'LastName': 'Yang', 'Affiliation': ""President's Office, Aerospace 731 Hospital, Beijing, China.""}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Clinical Pharmacology, Aerospace Center Hospital, Beijing, China.'}]",Pharmacotherapy,['10.1002/phar.2432'] 1615,32502306,Motivational processes during physical endurance tasks.,"PURPOSE Motivational processes are insufficiently recognized in models of human endurance. Hence, two studies examined a motivational model proposing that the quality of pre-task autonomous motivation influences performance at high intensity via the in-task temptation to reduce effort and value of goal pursuit. METHODS The studies involved 40 participants each (Study 1:33% female, M age  = 21.55, SD = 1.97; Study 2:45% female, M age  = 22.65, SD = 2.61) completing measures of autonomous motivation prior to a 10-minute cycling task. Measures of the temptation to reduce effort and value of goal pursuit were taken every minute during the trial (Study 1) or near the midpoint of the trial (Study 2). Data were analyzed using multilevel growth and parallel mediation models. RESULTS In both studies, autonomous motivation was associated with lower temptation to reduce effort and higher value of goal pursuit, which were subsequently characteristic of better performance. Study 1 revealed nuances within these relationships depending on whether task initiation or change over time was considered. In Study 2, indirect effects of autonomous motivation on performance via temptation to reduce effort (b = 0.20, 95% CIs 0.03-0.50) and goal value (b = 0.26, 95% CIs 0.01-0.44) were evidenced. CONCLUSION Two studies supported a theoretically viable model explaining the dynamics between pre-task and in-task motivation underpinning performance at high intensities.",2020,"In both studies, autonomous motivation was associated with lower temptation to reduce effort and higher value of goal pursuit, which were subsequently characteristic of better performance.","['40 participants each (Study 1: 33% female, M age = 21.55, SD = 1.97; Study 2: 45% female, M age = 22.65, SD = 2.61) completing measures of autonomous motivation prior to a ten-minute cycling task']",[],[],"[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0439232', 'cui_str': 'min'}]",[],[],40.0,0.0755075,"In both studies, autonomous motivation was associated with lower temptation to reduce effort and higher value of goal pursuit, which were subsequently characteristic of better performance.","[{'ForeName': 'Ian M', 'Initials': 'IM', 'LastName': 'Taylor', 'Affiliation': 'School of Sport, Exercise & Health Sciences, Loughborough University, Leicestershire, UK.'}, {'ForeName': 'Kieren', 'Initials': 'K', 'LastName': 'Smith', 'Affiliation': 'One-Eighty Psychology Behaviour Support, Oxford, UK.'}, {'ForeName': 'Raymon', 'Initials': 'R', 'LastName': 'Hunte', 'Affiliation': 'Nottingham Trent University, Nottingham, UK.'}]",Scandinavian journal of medicine & science in sports,['10.1111/sms.13739'] 1616,32502443,"Atezolizumab with or without bevacizumab in unresectable hepatocellular carcinoma (GO30140): an open-label, multicentre, phase 1b study.","BACKGROUND Dual blockade of PD-L1 and VEGF has enhanced anticancer immunity through multiple mechanisms and augmented antitumour activity in multiple malignancies. We aimed to assess the efficacy and safety of atezolizumab (anti-PD-L1) alone and combined with bevacizumab (anti-VEGF) in patients with unresectable hepatocellular carcinoma. METHODS GO30140 is an open-label, multicentre, multiarm, phase 1b study that enrolled patients at 26 academic centres and community oncology practices in seven countries worldwide. The study included five cohorts, and the two hepatocellular carcinoma cohorts, groups A and F, are described here. Inclusion criteria for these two groups included age 18 years and older; histologically, cytologically, or clinically (per American Association for the Study of Liver Diseases criteria) confirmed unresectable hepatocellular carcinoma that was not amenable to curative treatment; no previous systemic treatment; and Eastern Cooperative Oncology Group performance status of 0 or 1. In group A, all patients received atezolizumab (1200 mg) and bevacizumab (15 mg/kg) intravenously every 3 weeks. In group F, patients were randomly assigned (1:1) to receive intravenous atezolizumab (1200 mg) plus intravenous bevacizumab (15 mg/kg) every 3 weeks or atezolizumab alone by interactive voice-web response system using permuted block randomisation (block size of two) and stratification factors of geographical region; macrovascular invasion, extrahepatic spread, or both; and baseline α-fetoprotein concentration. Primary endpoints were confirmed objective response rate in all patients who received the combination treatment for group A and progression-free survival in the intention-to-treat population in group F, both assessed by an independent review facility according to Response Evaluation Criteria in Solid Tumors version 1.1. In both groups, safety was assessed in all patients who received at least one dose of any study treatment. This study is registered with ClinicalTrials.gov, NCT02715531, and is closed to enrolment. FINDINGS In group A, 104 patients were enrolled between July 20, 2016, and July 31, 2018, and received atezolizumab plus bevacizumab. With a median follow-up of 12·4 months (IQR 8·0-16·2), 37 (36%; 95% CI 26-46) of 104 patients had a confirmed objective response. The most common grade 3-4 treatment-related adverse events were hypertension (13 [13%]) and proteinuria (seven [7%]). Treatment-related serious adverse events occurred in 25 (24%) patients and treatment-related deaths in three (3%) patients (abnormal hepatic function, hepatic cirrhosis, and pneumonitis). In group F, 119 patients were enrolled and randomly assigned (60 to atezolizumab plus bevacizumab; 59 to atezolizumab monotherapy) between May 18, 2018, and March 7, 2019. With a median follow-up of 6·6 months (IQR 5·5-8·5) for the atezolizumab plus bevacizumab group and 6·7 months (4·2-8·2) for the atezolizumab monotherapy group, median progression-free survival was 5·6 months (95% CI 3·6-7·4) versus 3·4 months (1·9-5·2; hazard ratio 0·55; 80% CI 0·40-0·74; p=0·011). The most common grade 3-4 treatment-related adverse events in group F were hypertension (in three [5%] patients in the atezolizumab plus bevacizumab group; none in the atezolizumab monotherapy group) and proteinuria (in two [3%] patients in the atezolizumab plus bevacizumab group; none in the atezolizumab monotherapy group). Treatment-related serious adverse events occurred in seven (12%) patients in the atezolizumab plus bevacizumab group and two (3%) patients in the atezolizumab monotherapy group. There were no treatment-related deaths. INTERPRETATION Our study shows longer progression-free survival with a combination of atezolizumab plus bevacizumab than with atezolizumab alone in patients with unresectable hepatocellular carcinoma not previously treated with systemic therapy. Therefore, atezolizumab plus bevacizumab might become a promising treatment option for these patients. This combination is being compared with standard-of-care sorafenib in a phase 3 trial. FUNDING F Hoffmann-La Roche/Genentech.",2020,The most common grade 3-4 treatment-related adverse events in group F were hypertension,"['119 patients', 'patients with unresectable hepatocellular carcinoma not previously treated with systemic therapy', 'unresectable hepatocellular carcinoma (GO30140', 'Inclusion criteria for these two groups included age 18 years and older; histologically, cytologically, or clinically (per American Association for the Study of Liver Diseases criteria) confirmed unresectable hepatocellular carcinoma that was not amenable to curative treatment; no previous systemic treatment; and Eastern Cooperative Oncology Group performance status of 0 or 1', 'enrolled patients at 26 academic centres and community oncology practices in seven countries worldwide', '104 patients were enrolled between July 20, 2016, and July 31, 2018, and received', 'patients with unresectable hepatocellular carcinoma']","['atezolizumab alone', 'intravenous atezolizumab (1200 mg) plus intravenous bevacizumab', 'atezolizumab (anti-PD-L1) alone and combined with bevacizumab (anti-VEGF', 'atezolizumab', 'atezolizumab alone by interactive voice-web response system', 'Atezolizumab with or without bevacizumab', 'standard-of-care sorafenib', 'atezolizumab monotherapy', 'bevacizumab', 'atezolizumab plus bevacizumab']","['median progression-free survival', 'progression-free survival', 'efficacy and safety', 'serious adverse events', 'proteinuria', 'objective response rate', 'hypertension']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1112459', 'cui_str': 'Liver cell carcinoma non-resectable'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0023895', 'cui_str': 'Disease of liver'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C1276305', 'cui_str': 'Curative - procedure intent'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C1520224', 'cui_str': 'ECOG performance status'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C4517527', 'cui_str': '104'}]","[{'cui': 'C4055433', 'cui_str': 'atezolizumab'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C4517548', 'cui_str': '1200'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0965245', 'cui_str': 'CD274 protein, human'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C1516119', 'cui_str': 'sorafenib'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0033687', 'cui_str': 'Proteinuria'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}]",104.0,0.146586,The most common grade 3-4 treatment-related adverse events in group F were hypertension,"[{'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Lee', 'Affiliation': 'Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Baek-Yeol', 'Initials': 'BY', 'LastName': 'Ryoo', 'Affiliation': 'Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Chih-Hung', 'Initials': 'CH', 'LastName': 'Hsu', 'Affiliation': 'National Taiwan University Hospital, Taipei, Taiwan.'}, {'ForeName': 'Kazushi', 'Initials': 'K', 'LastName': 'Numata', 'Affiliation': 'Yokohama City University Medical Center, Yokohama, Japan.'}, {'ForeName': 'Stacey', 'Initials': 'S', 'LastName': 'Stein', 'Affiliation': 'Yale School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Verret', 'Affiliation': 'Genentech, South San Francisco, CA, USA.'}, {'ForeName': 'Stephen P', 'Initials': 'SP', 'LastName': 'Hack', 'Affiliation': 'Genentech, South San Francisco, CA, USA.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Spahn', 'Affiliation': 'Genentech, South San Francisco, CA, USA.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Liu', 'Affiliation': 'Genentech, South San Francisco, CA, USA.'}, {'ForeName': 'Heba', 'Initials': 'H', 'LastName': 'Abdullah', 'Affiliation': 'Genentech, South San Francisco, CA, USA.'}, {'ForeName': 'Yulei', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Genentech, South San Francisco, CA, USA.'}, {'ForeName': 'Aiwu Ruth', 'Initials': 'AR', 'LastName': 'He', 'Affiliation': 'Lombardi Comprehensive Cancer Center, Georgetown University, Washington, DC, USA.'}, {'ForeName': 'Kyung-Hun', 'Initials': 'KH', 'LastName': 'Lee', 'Affiliation': 'Division of Hematology and Oncology, Department of Internal Medicine, Seoul National University Hospital, Seoul, South Korea. Electronic address: kyunghunlee@snu.ac.kr.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Oncology,['10.1016/S1470-2045(20)30156-X'] 1617,32504862,Comparative Study of Mizoribine and Mycophenolate Mofetil Combined with a Calcineurin Inhibitor-Based Immunosuppressive Regimen in Patients with Alternative Donor Hematopoietic Cell Transplantation.,"Cytomegalovirus (CMV) infection and graft-versus-host disease (GVHD) remain the major causes of nonrelapse mortality (NRM) in patients following alternative donor hematopoietic stem cell transplantation (HCT). Mizoribine (MZR) showed an anti-CMV effect in addition to its immunosuppressive effect in patients with renal transplantation. In this study, we aimed to evaluate the efficacy and safety of MZR combined with a calcineurin inhibitor (CNI) as a method of prophylactic immunosuppression in recipients following alternative donor HCT. Eighty patients were enrolled in the study and randomized to the MZR (n = 40) or MMF (n = 40) cohort before transplantation conditioning. Analyses involved a comparison of the outcomes between the 2 cohorts, as well as risk analyses of early nonrelapse mortality (NRM) and severe CMV infection. In contrast to MMF, MZR was associated with a lower but statistically nonsignificant median CMV DNA peak load (P = .075), significantly fewer episodes of persistent/refractory infection (odds ratio [OR], .12), and a lower failure rate of CMV treatment (OR, .82), but a significantly higher rate of hyperuricemia (OR, 2.75). Transplantation efficacy was comparable in the 2 cohorts regarding engraftment, the development of secondary poor graft function and GVHD, and the estimated OS and PFS. The 1-year NRM of the MZR cohort did not differ from that of the MMF cohort, whereas the rate of 1-year NRM caused by viral infections was reduced in the MZR cohort and was of borderline statistical significance (P = .05). In the multivariate analysis, lower doses of CD34 + cells in grafts (hazard ratio [HR], 3.65) and persistent/refractory CMV infections (versus no CMV infection: HR, 7.31; versus CMV infection that was not persistent/refractory: HR, 4.46) were predictors of increased 1-year NRM. The use of MMF (versus MZR cohort: OR, 11.54) and grade II-IV acute GVHD (OR, 15.32) were independent risk factors for developing persistent/refractory CMV infection. When combined with CNIs, MZR functioned well in terms of both immunosuppression and reduced severity of CMV infection; however, further studies are warranted to verify its use as a potential immunosuppressant for alternative donor HCT.",2020,"The transplant efficacy was comparable between the two cohorts regarding engraftment, the development of secondary poor graft function (sPGF) and GvHD, and the estimated OS and PFS.","['patients with renal transplantation', 'recipients following alternative donor HCT', 'patients following alternative donor HCT', 'for hematopoietic cell transplantation', 'patients with alternative donor hematopoietic cell transplantation', 'Eighty patients were enrolled in the study and randomized to the MZR (n\u202f=\u202f40) and MMF (n\u202f=\u202f40) cohorts before transplant conditioning']","['mizoribine and mycophenolate mofetil combined with a calcineurin inhibitor-based immunosuppressive regimen', 'Mizoribine vs mycophenolate mofetil', 'Mizoribine (MZR', 'MMF', 'MZR combined with CNIs']","['risk analyses of early NRM and severe CMV infection', 'episodes of persistent/refractory infection', 'median CMV DNA peak load', 'failure rate of CMV treatment', 'transplant efficacy', 'refractory CMV infections', 'rate of 1-y NRM caused by viral infections', 'efficacy and safety', 'occurrence of hyperuricemia']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0018935', 'cui_str': 'Hematocrit determination'}, {'cui': 'C0472699', 'cui_str': 'Hemopoietic stem cell transplant'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0128608', 'cui_str': 'Mizoribine'}, {'cui': 'C0083765', 'cui_str': 'NMF protocol'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0376450', 'cui_str': 'Conditioning, Transplantation'}]","[{'cui': 'C0128608', 'cui_str': 'Mizoribine'}, {'cui': 'C0209368', 'cui_str': 'mycophenolate mofetil'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C1453118', 'cui_str': 'CABIN1 protein, human'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0021081', 'cui_str': 'Immunosuppressant agent'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0083765', 'cui_str': 'NMF protocol'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0010823', 'cui_str': 'Cytomegalovirus infection'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0369083', 'cui_str': 'Cytomegalovirus DNA'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0042769', 'cui_str': 'Viral disease'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0740394', 'cui_str': 'Hyperuricemia'}]",80.0,0.0245141,"The transplant efficacy was comparable between the two cohorts regarding engraftment, the development of secondary poor graft function (sPGF) and GvHD, and the estimated OS and PFS.","[{'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': 'Transplantation Center or Anemia Disease Center, Institute of Hematology & Blood Disease Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Tianjin, China.'}, {'ForeName': 'Mingzhe', 'Initials': 'M', 'LastName': 'Han', 'Affiliation': 'Transplantation Center or Anemia Disease Center, Institute of Hematology & Blood Disease Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Tianjin, China.'}, {'ForeName': 'Donglin', 'Initials': 'D', 'LastName': 'Yang', 'Affiliation': 'Transplantation Center or Anemia Disease Center, Institute of Hematology & Blood Disease Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Tianjin, China.'}, {'ForeName': 'Rongli', 'Initials': 'R', 'LastName': 'Zhang', 'Affiliation': 'Transplantation Center or Anemia Disease Center, Institute of Hematology & Blood Disease Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Tianjin, China.'}, {'ForeName': 'Qiaoling', 'Initials': 'Q', 'LastName': 'Ma', 'Affiliation': 'Transplantation Center or Anemia Disease Center, Institute of Hematology & Blood Disease Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Tianjin, China.'}, {'ForeName': 'Aiming', 'Initials': 'A', 'LastName': 'Pang', 'Affiliation': 'Transplantation Center or Anemia Disease Center, Institute of Hematology & Blood Disease Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Tianjin, China.'}, {'ForeName': 'Weihua', 'Initials': 'W', 'LastName': 'Zhai', 'Affiliation': 'Transplantation Center or Anemia Disease Center, Institute of Hematology & Blood Disease Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Tianjin, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'He', 'Affiliation': 'Transplantation Center or Anemia Disease Center, Institute of Hematology & Blood Disease Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Tianjin, China.'}, {'ForeName': 'Jialin', 'Initials': 'J', 'LastName': 'Wei', 'Affiliation': 'Transplantation Center or Anemia Disease Center, Institute of Hematology & Blood Disease Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Tianjin, China.'}, {'ForeName': 'Erlie', 'Initials': 'E', 'LastName': 'Jiang', 'Affiliation': 'Transplantation Center or Anemia Disease Center, Institute of Hematology & Blood Disease Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Tianjin, China.'}, {'ForeName': 'Sizhou', 'Initials': 'S', 'LastName': 'Feng', 'Affiliation': 'Transplantation Center or Anemia Disease Center, Institute of Hematology & Blood Disease Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Tianjin, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Transplantation Center or Anemia Disease Center, Institute of Hematology & Blood Disease Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Tianjin, China. Electronic address: zhangli@ihcams.ac.cn.'}]",Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation,['10.1016/j.bbmt.2020.05.022'] 1618,32504895,Patterns of daytime physical activity in patients with chronic fatigue syndrome.,"OBJECTIVES To classify patients with chronic fatigue syndrome (CFS) by pattern of physical activity and determine the clinical associations of each type. METHODS 579 out of 641 participants with CFS from the PACE (Pacing, graded Activity, Cognitive behavioural therapy: a randomised Evaluation) trial wore an Actiwatch (accelerometer) for between 3 and 7 days before any trial treatments, which provided a measure of physical activity. Participants' activity was categorised into one of four patterns (pervasively inactive, pervasively active, boom and bust, or indeterminate) primarily using a priori definitions of activity. Clinical associations were sought with each group using an exploratory logistic regression with the indeterminate activity group being the reference group. RESULTS 124 (21%) of the participants were classified as pervasively inactive, 65 (11%) as pervasively active, 172 (30%) showed a 'boom and bust' pattern of activity, and 218 (38%) had an indeterminate pattern. Pervasively inactive patients were more physically disabled, those in the pervasively active group were more anxious, and those in the boom and bust group had more sleep disturbance. CONCLUSION We were able to classify patients with CFS into groups by their daytime activity pattern. The different patterns of activity were associated with important clinical variables, suggesting that they might be helpful in determining prognosis and targeting treatments. These associations need replication.",2020,"Pervasively inactive patients were more physically disabled, those in the pervasively active group were more anxious, and those in the boom and bust group had more sleep disturbance. ","['patients with chronic fatigue syndrome', '579 out of 641 participants with CFS from the PACE (Pacing, graded Activity, Cognitive behavioural therapy', 'patients with chronic fatigue syndrome (CFS']",[],"['sleep disturbance', 'daytime physical activity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015674', 'cui_str': 'Chronic fatigue syndrome'}, {'cui': 'C0287990', 'cui_str': 'Furin'}, {'cui': 'C0562458', 'cui_str': 'Pacing up and down'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]",[],"[{'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}, {'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",641.0,0.0298142,"Pervasively inactive patients were more physically disabled, those in the pervasively active group were more anxious, and those in the boom and bust group had more sleep disturbance. ","[{'ForeName': 'E', 'Initials': 'E', 'LastName': 'King', 'Affiliation': 'Barts and the London School of Medicine and Dentistry, Queen Mary University of London, UK.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Beynon', 'Affiliation': 'Centre for Psychiatry, Wolfson Institute of Preventive Medicine, Barts and the London School of Medicine, Queen Mary University, London, UK.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Chalder', 'Affiliation': ""Academic Department of Psychological Medicine, King's College London, Weston Education Centre, London, UK. Electronic address: Trudie.chalder@kcl.ac.uk.""}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Sharpe', 'Affiliation': 'Psychological Medicine Research, Department of Psychiatry, University of Oxford, Oxford, UK.'}, {'ForeName': 'P D', 'Initials': 'PD', 'LastName': 'White', 'Affiliation': 'Centre for Psychiatry, Wolfson Institute of Preventive Medicine, Barts and the London School of Medicine, Queen Mary University, London, UK.'}]",Journal of psychosomatic research,['10.1016/j.jpsychores.2020.110154'] 1619,32510158,Nondigestible Carbohydrates Affect Metabolic Health and Gut Microbiota in Overweight Adults after Weight Loss.,"BACKGROUND The composition of diets consumed following weight loss (WL) can have a significant impact on satiety and metabolic health. OBJECTIVE This study was designed to test the effects of including a nondigestible carbohydrate to achieve weight maintenance (WM) following a period of WL. METHODS Nineteen volunteers [11 females and 8 males, aged 20-62 y; BMI (kg/m2): 27-42] consumed a 3-d maintenance diet (15%:30%:55%), followed by a 21-d WL diet (WL; 30%:30%:40%), followed by 2 randomized 10-d WM diets (20%:30%:50% of energy from protein:fat:carbohydrate) containing either resistant starch type 3 (RS-WM; 22 or 26 g/d for females and males, respectively) or no RS (C-WM) in a within-subject crossover design without washout periods. The primary outcome, WM after WL, was analyzed by body weight. Secondary outcomes of fecal microbiota composition and microbial metabolite concentrations and gut hormones were analyzed in fecal samples and blood plasma, respectively. All outcomes were assessed at the end of each dietary period. RESULTS Body weight was similar after the RS-WM and C-WM diets (90.7 and 90.8 kg, respectively), with no difference in subjectively rated appetite. During the WL diet period plasma ghrelin increased by 36% (P < 0.001), glucose-dependent insulinotropic polypeptide (GIP) decreased by 33% (P < 0.001), and insulin decreased by 46% (P < 0.001), but no significant differences were observed during the RS-WM and C-WM diet periods. Fasting blood glucose was lower after the RS-WM diet (5.59 ± 0.31 mmol/L) than after the C-WM diet [5.75 ± 0.49 mmol/L; P = 0.015; standard error of the difference between the means (SED): 0.09]. Dietary treatments influenced the fecal microbiota composition (R2 = 0.054, P = 0.031) but not diversity. CONCLUSIONS The metabolic benefits, for overweight adults, from WL were maintained through a subsequent WM diet with higher total carbohydrate intake. Inclusion of resistant starch in the WM diet altered gut microbiota composition positively and resulted in lower fasting glucose compared with the control, with no apparent change in appetite. This trial was registered at clinicaltrials.gov as NCT01724411.",2020,"Inclusion of resistant starch in the WM diet altered gut microbiota composition positively and resulted in lower fasting glucose compared with the control, with no apparent change in appetite.","['Overweight Adults after Weight Loss', 'Nineteen volunteers', '11 females and 8 males, aged 20-62 y; BMI (kg/m2): 27-42']","['Nondigestible Carbohydrates', 'nondigestible carbohydrate', 'resistant starch type 3 (RS-WM']","['glucose-dependent insulinotropic polypeptide (GIP', 'weight maintenance (WM', 'fecal samples and blood plasma', 'plasma ghrelin', 'insulin', 'Fasting blood glucose', 'appetite', 'Body weight', 'fecal microbiota composition and microbial metabolite concentrations and gut hormones', 'fecal microbiota composition', 'gut microbiota composition', 'subjectively rated appetite', 'lower fasting glucose']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0450337', 'cui_str': '19'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}]","[{'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0038179', 'cui_str': 'Starch'}, {'cui': 'C0441731', 'cui_str': 'Type 3'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}]","[{'cui': 'C0017132', 'cui_str': 'Gastric inhibitory polypeptide'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0911014', 'cui_str': 'Ghrelin'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0017189', 'cui_str': 'Gastrointestinal tract structure'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}]",19.0,0.0602516,"Inclusion of resistant starch in the WM diet altered gut microbiota composition positively and resulted in lower fasting glucose compared with the control, with no apparent change in appetite.","[{'ForeName': 'Alexandra M', 'Initials': 'AM', 'LastName': 'Johnstone', 'Affiliation': 'The Rowett Institute, University of Aberdeen, Foresterhill, United Kingdom.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Kelly', 'Affiliation': 'Functional and Comparative Genomics, and Psychological Sciences, University of Liverpool, Liverpool, United Kingdom.'}, {'ForeName': 'Sheila', 'Initials': 'S', 'LastName': 'Ryan', 'Affiliation': 'Functional and Comparative Genomics, and Psychological Sciences, University of Liverpool, Liverpool, United Kingdom.'}, {'ForeName': 'Reyna', 'Initials': 'R', 'LastName': 'Romero-Gonzalez', 'Affiliation': 'The Rowett Institute, University of Aberdeen, Foresterhill, United Kingdom.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'McKinnon', 'Affiliation': 'The Rowett Institute, University of Aberdeen, Foresterhill, United Kingdom.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Fyfe', 'Affiliation': 'The Rowett Institute, University of Aberdeen, Foresterhill, United Kingdom.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Naslund', 'Affiliation': 'Karolinska Institute, Stockholm, Sweden.'}, {'ForeName': 'Ruben', 'Initials': 'R', 'LastName': 'Lopez-Nicolas', 'Affiliation': 'Department of Food Science and Nutrition, Faculty of Veterinary Sciences, Regional Campus of International Excellence ""Campus Mare Nostrum"", University of Murcia, Murcia, Spain.'}, {'ForeName': 'Douwina', 'Initials': 'D', 'LastName': 'Bosscher', 'Affiliation': 'Cargill R&D Centre Europe, Vilvoorde, Belgium.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Bonnema', 'Affiliation': 'Cargill R&D Centre NA, Minneapolis, MN, USA.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Frontela-Saseta', 'Affiliation': 'Department of Food Science and Nutrition, Faculty of Veterinary Sciences, Regional Campus of International Excellence ""Campus Mare Nostrum"", University of Murcia, Murcia, Spain.'}, {'ForeName': 'Gaspar', 'Initials': 'G', 'LastName': 'Ros-Berruezo', 'Affiliation': 'Department of Food Science and Nutrition, Faculty of Veterinary Sciences, Regional Campus of International Excellence ""Campus Mare Nostrum"", University of Murcia, Murcia, Spain.'}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'Horgan', 'Affiliation': 'Biomathematics and Statistics Scotland, Aberdeen, United Kingdom.'}, {'ForeName': 'Xiaolei', 'Initials': 'X', 'LastName': 'Ze', 'Affiliation': 'The Rowett Institute, University of Aberdeen, Foresterhill, United Kingdom.'}, {'ForeName': 'Jo', 'Initials': 'J', 'LastName': 'Harrold', 'Affiliation': 'Appetite and Obesity Research Group, Department of Psychological Sciences, University of Liverpool, Liverpool, United Kingdom.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Halford', 'Affiliation': 'Appetite and Obesity Research Group, Department of Psychological Sciences, University of Liverpool, Liverpool, United Kingdom.'}, {'ForeName': 'Silvia W', 'Initials': 'SW', 'LastName': 'Gratz', 'Affiliation': 'The Rowett Institute, University of Aberdeen, Foresterhill, United Kingdom.'}, {'ForeName': 'Sylvia H', 'Initials': 'SH', 'LastName': 'Duncan', 'Affiliation': 'The Rowett Institute, University of Aberdeen, Foresterhill, United Kingdom.'}, {'ForeName': 'Soraya', 'Initials': 'S', 'LastName': 'Shirazi-Beechey', 'Affiliation': 'Functional and Comparative Genomics, and Psychological Sciences, University of Liverpool, Liverpool, United Kingdom.'}, {'ForeName': 'Harry J', 'Initials': 'HJ', 'LastName': 'Flint', 'Affiliation': 'The Rowett Institute, University of Aberdeen, Foresterhill, United Kingdom.'}]",The Journal of nutrition,['10.1093/jn/nxaa124'] 1620,32511981,"Ripretinib in patients with advanced gastrointestinal stromal tumours (INVICTUS): a double-blind, randomised, placebo-controlled, phase 3 trial.","BACKGROUND Resistance to approved inhibitors of KIT proto-oncogene, receptor tyrosine kinase (KIT), and platelet-derived growth factor receptor α (PDGFRA) is a clinical challenge for patients with advanced gastrointestinal stromal tumours. We compared the efficacy and safety of ripretinib, a switch-control tyrosine kinase inhibitor active against a broad spectrum of KIT and PDGFRA mutations, with placebo in patients with previously treated, advanced gastrointestinal stromal tumours. METHODS In this double-blind, randomised, placebo-controlled, phase 3 study, we enrolled adult patients in 29 specialised hospitals in 12 countries. We included patients aged 18 years or older who had advanced gastrointestinal stromal tumours with progression on at least imatinib, sunitinib, and regorafenib or documented intolerance to any of these treatments despite dose modifications, and who had an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2. Eligible patients were randomly assigned (2:1) to receive either oral ripretinib 150 mg once daily (ripretenib group) or placebo once daily (placebo group). Randomisation was done via an interactive response system using randomly permuted block sizes of six and stratified according to number of previous therapies and ECOG performance status. Patients, investigators, research staff, and the sponsor study team were masked to a patient's treatment allocation until the blinded independent central review (BICR) showed progressive disease for the patient. The primary endpoint was progression-free survival, assessed by BICR. The primary analysis was done in the intention-to-treat population and safety was assessed in patients who received at least one dose of study drug. Patients randomly assigned to placebo were permitted to cross over to ripretinib 150 mg at the time of disease progression. The INVICTUS study is registered with ClinicalTrials.gov, number NCT03353753, and with WHO International Clinical Trials Registry Platform, number EUCTR2017-002446-76-ES; follow-up is ongoing. FINDINGS Between Feb 27, 2018, and Nov 16, 2018, 129 of 154 assessed patients were randomly assigned to receive either ripretinib (n=85) or placebo (n=44). At data cutoff (May 31, 2019), at a median follow-up of 6·3 months (IQR 3·2-8·2) in the ripretinib group and 1·6 months (1·1-2·7) in the placebo group, 51 patients in the ripretinib group and 37 in the placebo group had had progression-free survival events. In the double-blind period, median progression-free survival was 6·3 months (95% CI 4·6-6·9) with ripretinib compared with 1·0 months (0·9-1·7) with placebo (hazard ratio 0·15, 95% CI 0·09-0·25; p<0·0001). The most common (>2%) grade 3 or 4 treatment-related treatment-emergent adverse events in the ripretinib group (n=85) included lipase increase (four [5%]), hypertension (three [4%]), fatigue (two [2%]), and hypophosphataemia (two (2%]); in the placebo group (n=43), the most common (>2%) grade 3 or 4 treatment-related treatment-emergent adverse events were anaemia (three [7%]), fatigue (one [2%]), diarrhoea (one [2%]), decreased appetite (one [2%]), dehydration (one [2%]), hyperkalaemia (one [2%]), acute kidney injury (one [2%]), and pulmonary oedema (one [2%]). Treatment-related serious adverse events were reported in eight (9%) of 85 patients who received ripretinib and three (7%) of 43 patients who received placebo. Treatment-related deaths occurred in one patient in the placebo group (septic shock and pulmonary oedema) and one patient in the ripretinib group (cause of death unknown; the patient died during sleep). INTERPRETATION Ripretinib significantly improved median progression-free survival compared with placebo and had an acceptable safety profile in patients with advanced gastrointestinal stromal tumours who were resistant to approved treatments. FUNDING Deciphera Pharmaceuticals.",2020,"Ripretinib significantly improved median progression-free survival compared with placebo and had an acceptable safety profile in patients with advanced gastrointestinal stromal tumours who were resistant to approved treatments. ","['enrolled adult patients in 29 specialised hospitals in 12 countries', 'patients aged 18 years or older who had advanced gastrointestinal stromal tumours with progression on at least imatinib, sunitinib, and regorafenib or documented intolerance to any of these treatments despite dose modifications, and who had an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2', 'patients with advanced gastrointestinal stromal tumours who were resistant to approved treatments', 'Between Feb 27, 2018, and Nov 16, 2018, 129 of 154 assessed patients', 'patients with previously treated, advanced gastrointestinal stromal tumours', 'patients with advanced gastrointestinal stromal tumours (INVICTUS', 'patients with advanced gastrointestinal stromal tumours', 'Eligible patients']","['ripretinib', 'oral ripretinib 150 mg once daily (ripretenib group) or placebo once daily (placebo', 'placebo']","['lipase increase', 'median progression-free survival', 'progression-free survival events', 'intention-to-treat population and safety', 'fatigue', 'hyperkalaemia', 'acute kidney injury', 'septic shock and pulmonary oedema', 'diarrhoea', 'dehydration', 'serious adverse events', 'pulmonary oedema', 'hypertension', 'deaths', 'decreased appetite', 'progression-free survival, assessed by BICR']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0238198', 'cui_str': 'Gastrointestinal stromal tumor'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0935989', 'cui_str': 'imatinib'}, {'cui': 'C1176020', 'cui_str': 'sunitinib'}, {'cui': 'C2980094', 'cui_str': 'regorafenib'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C0231199', 'cui_str': 'Intolerance'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0205540', 'cui_str': 'Approved'}, {'cui': 'C0949920', 'cui_str': 'Norovirus'}, {'cui': 'C1520439', 'cui_str': '129 Strain Mouse'}, {'cui': 'C5191279', 'cui_str': '154'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0556983', 'cui_str': 'Once daily'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0549475', 'cui_str': 'Lipase increased'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0020461', 'cui_str': 'Hyperkalemia'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C0036983', 'cui_str': 'Septic shock'}, {'cui': 'C0034063', 'cui_str': 'Pulmonary edema'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0011175', 'cui_str': 'Dehydration'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0232462', 'cui_str': 'Decrease in appetite'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0282443', 'cui_str': 'Review'}]",,0.788248,"Ripretinib significantly improved median progression-free survival compared with placebo and had an acceptable safety profile in patients with advanced gastrointestinal stromal tumours who were resistant to approved treatments. ","[{'ForeName': 'Jean-Yves', 'Initials': 'JY', 'LastName': 'Blay', 'Affiliation': 'Department of Medicine, Centre Léon Bérard, Lyon, France; Headquarters, Unicancer, Paris, France; LYRICAN, Lyon, France; Faculte Lyon Est, Université Claude Bernard, Lyon, France. Electronic address: jean-yves.blay@lyon.unicancer.fr.'}, {'ForeName': 'César', 'Initials': 'C', 'LastName': 'Serrano', 'Affiliation': ""Department of Medical Oncology, Vall d'Hebron Institute of Oncology, Barcelona, Spain.""}, {'ForeName': 'Michael C', 'Initials': 'MC', 'LastName': 'Heinrich', 'Affiliation': 'Department of Medicine, Portland VA Health Care System, Portland, OR, USA; OHSU Knight Cancer Institute, Oregon Health & Science University, Portland, OR, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Zalcberg', 'Affiliation': 'Department of Epidemiology and Preventative Medicine, School of Public Health and Preventive Medicine, Monash University, Melbourne, VIC, Australia; Department of Medical Oncology, Alfred Health, Melbourne, VIC, Australia.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Bauer', 'Affiliation': 'Department of Medical Oncology, West German Cancer Center, University of Duisburg-Essen, Essen, Germany; German Consortium for Translational Cancer Research (DKTK), Partner Site Essen, Germany.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Gelderblom', 'Affiliation': 'Department of Medical Oncology, Leiden University Medical Center, Leiden, Netherlands.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Schöffski', 'Affiliation': 'Leuven Cancer Institute and Department of General Medical Oncology, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'Robin L', 'Initials': 'RL', 'LastName': 'Jones', 'Affiliation': 'Sarcoma Unit, The Royal Marsden NHS Foundation Trust, London, UK; Division of Clinical Studies, The Institute of Cancer Research, London, UK.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Attia', 'Affiliation': 'Department of Hematology and Oncology, Mayo Clinic, Jacksonville, FL, USA.'}, {'ForeName': 'Gina', 'Initials': 'G', 'LastName': ""D'Amato"", 'Affiliation': 'Sylvester Comprehensive Cancer Center, University of Miami Health System, Miami, FL, USA.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Chi', 'Affiliation': 'Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA; Department of Medicine, Weill Cornell Medicine, New York, NY, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Reichardt', 'Affiliation': 'Department of Oncology, Helios Klinikum Berlin-Buch, Berlin, Germany.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Meade', 'Affiliation': 'Deciphera Pharmaceuticals, Waltham, MA, USA.'}, {'ForeName': 'Kelvin', 'Initials': 'K', 'LastName': 'Shi', 'Affiliation': 'Deciphera Pharmaceuticals, Waltham, MA, USA.'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Ruiz-Soto', 'Affiliation': 'Deciphera Pharmaceuticals, Waltham, MA, USA.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'George', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'von Mehren', 'Affiliation': 'Department of Hematology and Medical Oncology, Fox Chase Cancer Center, Philadelphia, PA, USA.'}]",The Lancet. Oncology,['10.1016/S1470-2045(20)30168-6'] 1621,32512124,Placebo-induced pain reduction is associated with negative coupling between brain networks at rest.,"Placebos can reduce pain by inducing beliefs in the effectiveness of an actually inert treatment. Such top-down effects on pain typically engage lateral and medial prefrontal regions, the insula, somatosensory cortex, as well as the thalamus and brainstem during pain anticipation or perception. Considering the level of large-scale brain networks, these regions spatially align with fronto-parietal/executive control, salience, and sensory-motor networks, but it is unclear if and how placebos alter interactions between them during rest. Here, we investigated how placebo analgesia affected intrinsic network coupling. Ninety-nine human participants were randomly assigned to a placebo or control group and underwent resting-state fMRI after pain processing. Results revealed inverse coupling between two resting-state networks in placebo but not control participants. Specifically, networks comprised the bilateral somatosensory cortex and posterior insula, as well as the brainstem, thalamus, striatal regions, dorsal and rostral anterior cingulate cortex, and the anterior insula, respectively. Across participants, more negative between-network coupling was associated with lower individual pain intensity as assessed during a preceding pain task, and there was no significant relation with expectations of medication effectiveness in the placebo group. Altogether, these findings provide initial evidence that placebo analgesia affects the intrinsic communication between large-scale brain networks, even in the absence of pain. We suggest a theoretical model where placebo analgesia might affect processing within a descending pain-modulatory network, potentially segregating it from somatosensory regions that may code for painful experiences.",2020,"Across participants, more negative between-network coupling was associated with lower individual pain intensity as assessed during a preceding pain task, and there was no significant relation with expectations of medication effectiveness in the placebo group.",['Ninety-nine human participants'],"['Placebos', 'Placebo', 'placebo or control group and underwent resting-state fMRI after pain processing', 'placebo']","['individual pain intensity', 'pain reduction', 'medication effectiveness', 'pain']","[{'cui': 'C3828813', 'cui_str': '99'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0423732', 'cui_str': 'After pains'}]","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",99.0,0.206348,"Across participants, more negative between-network coupling was associated with lower individual pain intensity as assessed during a preceding pain task, and there was no significant relation with expectations of medication effectiveness in the placebo group.","[{'ForeName': 'Isabella C', 'Initials': 'IC', 'LastName': 'Wagner', 'Affiliation': 'Social, Cognitive and Affective Neuroscience Unit, Department of Cognition, Emotion, and Methods in Psychology, Faculty of Psychology, University of Vienna, Liebiggasse 5, 1010, Vienna, Austria. Electronic address: isabella.wagner@univie.ac.at.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Rütgen', 'Affiliation': 'Social, Cognitive and Affective Neuroscience Unit, Department of Cognition, Emotion, and Methods in Psychology, Faculty of Psychology, University of Vienna, Liebiggasse 5, 1010, Vienna, Austria.'}, {'ForeName': 'Allan', 'Initials': 'A', 'LastName': 'Hummer', 'Affiliation': 'MR Centre of Excellence, Centre for Medical Physics and Biomedical Engineering, Medical University of Vienna, Währinger Gürtel 18-20, 1090, Vienna, Austria.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Windischberger', 'Affiliation': 'MR Centre of Excellence, Centre for Medical Physics and Biomedical Engineering, Medical University of Vienna, Währinger Gürtel 18-20, 1090, Vienna, Austria.'}, {'ForeName': 'Claus', 'Initials': 'C', 'LastName': 'Lamm', 'Affiliation': 'Social, Cognitive and Affective Neuroscience Unit, Department of Cognition, Emotion, and Methods in Psychology, Faculty of Psychology, University of Vienna, Liebiggasse 5, 1010, Vienna, Austria.'}]",NeuroImage,['10.1016/j.neuroimage.2020.117024'] 1622,32512127,"Creating while taking turns, the choice to unlocking group creative potential.","This study aimed to examine how communication modes affect creative idea generation in groups. Three communication mode conditions were created: natural (N), turn-taking (T), and electronic brainstorming (E). Participants were randomly recruited and grouped in dyads to solve one alternative uses task (AUT) in each condition, during which functional near-infrared spectroscopy (fNIRS)-based hyperscanning was used to record interpersonal neural responses. No difference was observed in AUT fluency across the three conditions, but AUT uniqueness was higher in the T condition than in the E condition. In addition, AUT uniqueness, AUT fluency, and perspective-taking behaviours increased faster in the T condition than in the other conditions. The T condition also showed higher perspective-taking behaviours than did the other conditions. Moreover, fNIRS data showed higher interpersonal brain synchronisation (IBS) increments at the right angular gyrus in the T condition than in the other conditions, which positively predicted perspective-taking behaviours between individuals during group creativity tasks. These findings indicate that when group members create together while taking turns, both creative performance and interpersonal interaction processes can be stimulated.",2020,"No difference was observed in AUT fluency across the three conditions, but AUT uniqueness was higher in the T condition than in the E condition.",[],[],"['AUT fluency, and perspective-taking behaviours', 'perspective-taking behaviours', 'interpersonal brain synchronisation (IBS', 'AUT fluency']",[],[],"[{'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}]",,0.0212556,"No difference was observed in AUT fluency across the three conditions, but AUT uniqueness was higher in the T condition than in the E condition.","[{'ForeName': 'Kelong', 'Initials': 'K', 'LastName': 'Lu', 'Affiliation': 'Shanghai Key Laboratory of Brain Functional Genomics, School of Psychology and Cognitive Science, East China Normal University, Shanghai, China.'}, {'ForeName': 'Tingting', 'Initials': 'T', 'LastName': 'Yu', 'Affiliation': 'Shanghai Key Laboratory of Brain Functional Genomics, School of Psychology and Cognitive Science, East China Normal University, Shanghai, China.'}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Hao', 'Affiliation': 'Shanghai Key Laboratory of Brain Functional Genomics, School of Psychology and Cognitive Science, East China Normal University, Shanghai, China. Electronic address: nhao@psy.ecnu.edu.cn.'}]",NeuroImage,['10.1016/j.neuroimage.2020.117025'] 1623,32513473,Incidental findings: A practical protocol for reporting elevated depressive symptoms in behavioral health research.,"Intervention studies conducted in caregivers often focus on improving mental health. Consequently, researchers may discover incidental findings like elevated depressive symptoms. Researchers have an ethical obligation to report incidental findings to participants, but no protocols exist for reporting behavioral health symptoms. The purpose of this paper was to describe a protocol for reporting elevated depressive symptoms to participants, based on the protocol used in a national randomized clinical trial of stress-reduction methods for 348 grandmothers raising grandchildren. Each questionnaire included the CES-D scale, and was scored immediately after completion. We established a cut-off score of 30 based on previous research. A registered nurse on the research team called participants with scores over 30 and ascertained whether the participant 1) was aware of the problem and 2) had sought help, and then offered additional resources. Overall, 94 (27%) participants had a CES-D score > 30. The majority (91%) were aware of the problem. About a third of the participants were on medication for their symptoms, and a third were seeing a therapist. Nine participants were not aware they had depressive symptoms. This paper outlines the ethical premise for developing our protocol, details of protocol development, and discussion for how research teams can apply this protocol to their work.",2020,The majority (91%) were aware of the problem.,['348 grandmothers raising grandchildren'],[],"['CES-D scale', 'mental health', 'depressive symptoms']","[{'cui': 'C4517733', 'cui_str': '348'}, {'cui': 'C0337474', 'cui_str': 'Grandmother'}, {'cui': 'C0442818', 'cui_str': 'Raised'}, {'cui': 'C0337548', 'cui_str': 'Grandchild'}]",[],"[{'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]",9.0,0.122803,The majority (91%) were aware of the problem.,"[{'ForeName': 'McKenzie K', 'Initials': 'MK', 'LastName': 'Wallace', 'Affiliation': 'Case Western Reserve University, Frances Payne Bolton School of Nursing, 10900 Euclid Ave, Cleveland, OH 44106-4409, United States of America. Electronic address: Mkw47@case.edu.'}, {'ForeName': 'Alexandra B', 'Initials': 'AB', 'LastName': 'Jeanblanc', 'Affiliation': 'Case Western Reserve University, Frances Payne Bolton School of Nursing, 10900 Euclid Ave, Cleveland, OH 44106-4409, United States of America.'}, {'ForeName': 'Carol M', 'Initials': 'CM', 'LastName': 'Musil', 'Affiliation': 'Case Western Reserve University, Frances Payne Bolton School of Nursing, 10900 Euclid Ave, Cleveland, OH 44106-4409, United States of America.'}]",Archives of psychiatric nursing,['10.1016/j.apnu.2020.04.005'] 1624,32515119,"The Effect of Preoperative Pentoxifylline on Postoperative Pain and Development of Secondary Hyperalgesia in Patients Undergoing Laparoscopic Appendectomy: A Randomized, Double-Blind, Placebo-Controlled Trial Study.","BACKGROUND After surgery and loss of anesthetic effect, postoperative pain can annoy the patient and affect patient satisfaction with treatment. This study was aimed at evaluating the effect of preoperative pentoxifylline (PTX) on postoperative pain and development of secondary hyperalgesia in patients undergoing laparoscopic appendectomy (LA). METHODS This randomized, double-blind, placebo-controlled clinical trial study was conducted on 91 eligible subjects with acute appendicitis referred to Shahid Beheshti hospital of Sabzevar, Iran, in 2018. The intervention and control groups were administered with a single oral dose of PTX (10 mg/kg) and placebo an hour before surgery, respectively. Postoperative pain was measured within 24 hours after surgery using a VAS, and the area of secondary hyperalgesia was measured 24 hours after surgery using the Stubhaug et al. method. RESULTS The mean age of the subjects was 26.74 ± 9.99 years, and 57.14% were female. Pain intensity during rest was significantly greater in the control group as compared to the PTX group 24 hours after surgery (VAS scores 2.19 ± 0.49 and 3.13 ± 0.66, respectively; P < 0.001). Moreover, pain intensity during cough was substantially lower in the PTX group compared with the control group 24 hours after surgery (VAS scores 2.65 ± 1.90 and 4.10 ± 2.60, respectively; P = 0.003 in turn). The dynamic hyperalgesia was significantly greater in the control group as compared with the PTX group (3.80 ± 1.82 and 7.43 ± 2.38, respectively; P < 0.001). CONCLUSIONS Findings suggest that oral administration of PTX 1 hour before surgery in patients undergoing LA can reduce postoperative pain in patients and prevent secondary hyperalgesia at a surgical site.",2020,"Moreover, pain intensity during cough was substantially lower in the PTX compared with the control group at 24 th hours after surgery (2.65±1.90 and 4.10±2.60; P = 0.003 in turn).","['patients undergoing laparoscopic appendectomy (LA', 'mean age of the subjects was 26.74±9.99 and 57.14% were female', '91 eligible subjects with acute appendicitis referred to Shahid Beheshti hospital of Sabzevar, Iran in 2018', 'patients undergoing laparoscopic appendectomy']","['PTX', 'preoperative pentoxifylline', 'preoperative pentoxifylline (PTX', 'placebo']","['pain intensity during cough', 'postoperative pain and development of secondary hyperalgesia', 'postoperative pain', 'Pain intensity', 'dynamic hyperalgesia', 'Visual Analog Score (VAS) and the area of secondary hyperalgesia', 'Postoperative pain']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0372525', 'cui_str': 'Laparoscopic appendectomy'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0022065', 'cui_str': 'Iran'}]","[{'cui': 'C0030899', 'cui_str': 'Pentoxifylline'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0751212', 'cui_str': 'Hyperalgesia, Secondary'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0020429', 'cui_str': 'Hyperalgesia'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}]",91.0,0.557522,"Moreover, pain intensity during cough was substantially lower in the PTX compared with the control group at 24 th hours after surgery (2.65±1.90 and 4.10±2.60; P = 0.003 in turn).","[{'ForeName': 'Samad', 'Initials': 'S', 'LastName': 'Nazemi', 'Affiliation': 'Cellular and Molecular Research Center, Department of Physiology and Pharmacology, Faculty of Medicine, Sabzevar University of Medical Sciences, Sabzevar, Iran.'}, {'ForeName': 'Akram', 'Initials': 'A', 'LastName': 'Taherian', 'Affiliation': 'Department of Nursing, School of Nursing, Islamic Azad University, Kashmar, Iran.'}, {'ForeName': 'Mahtab', 'Initials': 'M', 'LastName': 'Khajeh', 'Affiliation': 'Department of Surgery and Orthopedics, School of Medicine, Sabzevar University of Medical Sciences, Sabzevar, Iran.'}, {'ForeName': 'Ehsan', 'Initials': 'E', 'LastName': 'Shahrestanaki', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mostafa', 'Initials': 'M', 'LastName': 'Jafarpour', 'Affiliation': 'Student Research Committee, Sabzevar University of Medical Sciences, Sabzevar, Iran.'}, {'ForeName': 'Adeleh', 'Initials': 'A', 'LastName': 'Abdolalizadeh', 'Affiliation': 'Student Research Committee, Sabzevar University of Medical Sciences, Sabzevar, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Sahebkar', 'Affiliation': 'Student Research Committee, Sabzevar University of Medical Sciences, Sabzevar, Iran.'}]",Pain practice : the official journal of World Institute of Pain,['10.1111/papr.12925'] 1625,32520439,Cost-utility and cost-effectiveness analysis of a clinical medication review focused on personal goals in older persons with polypharmacy compared to usual care: Economic evaluation of the DREAMeR study.,"AIMS The ageing society may lead to increasing healthcare expenditure. A clinical medication review (CMR) could potentially reduce costs. The aim of this study is to perform a cost-utility and cost-effectiveness analysis from a societal perspective of a patient-centred CMR. METHODS A trial-based cost-utility and cost-effectiveness analysis was performed as part of the DREAMeR study, a pragmatic controlled trial that randomised patients aged ≥70 years using at least seven drugs to either CMR or usual care. Over six months, healthcare consumption and drug use were collected to estimate costs, and effects were collected in terms of quality-adjusted life years (QALYs) measured with EQ-5D-5 L and EQ-VAS and as reduced health-related complaints with impact on patients' daily lives. RESULTS The total mean costs per patient (n = 588) over six months were €4,189 ± 6,596 for the control group (n = 294) and €4,008 ± 6,678 for the intervention group (n = 294), including estimated intervention costs of €199 ± 67, which resulted in a mean incremental total cost savings of €181 for the intervention group compared to the control group. Compared to the control group, for the intervention group, the mean incremental QALYs over six months were: -0.00217 measured with EQ-5D and 0.003 measured with EQ-VAS. The incremental effect of reduced health-related complaints with impact was -0.34. There was a likelihood of >90% that the intervention was cost-saving. CONCLUSIONS The benefits of a patient-centred CMR were inconsistent with no benefits on HR-QoL measured with EQ-5D-5 L and small benefits on HR-QoL measured with EQ-VAS and health-related complaints with impact on patients' daily lives. Additionally, a CMR could potentially be cost saving from a societal perspective.",2020,The benefits of a patient-centred CMR were inconsistent with no benefits on HR-QoL measured with EQ-5D-5L and small benefits on HR-QoL measured with EQ-VAS and health-related complaints with impact on patients' daily lives.,"['older persons with polypharmacy', 'patients aged ≥70 years using ≥7 drugs to either CMR or usual care']",['CMR'],"['total mean costs', 'mean incremental QALYs', 'mean incremental total cost savings', 'cost-saving', 'Cost-utility and cost-effectiveness']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C2922974', 'cui_str': 'Polypharmacy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0560023', 'cui_str': 'Review of medication'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0560023', 'cui_str': 'Review of medication'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C0085550', 'cui_str': 'Cost Savings'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}]",,0.0718277,The benefits of a patient-centred CMR were inconsistent with no benefits on HR-QoL measured with EQ-5D-5L and small benefits on HR-QoL measured with EQ-VAS and health-related complaints with impact on patients' daily lives.,"[{'ForeName': 'Sanne', 'Initials': 'S', 'LastName': 'Verdoorn', 'Affiliation': 'Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences, Utrecht University, The Netherlands.'}, {'ForeName': 'Jeroen', 'Initials': 'J', 'LastName': 'van de Pol', 'Affiliation': 'Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences, Utrecht University, The Netherlands.'}, {'ForeName': 'Anke M', 'Initials': 'AM', 'LastName': 'Hövels', 'Affiliation': 'Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences, Utrecht University, The Netherlands.'}, {'ForeName': 'Henk-Frans', 'Initials': 'HF', 'LastName': 'Kwint', 'Affiliation': 'SIR Institute for Pharmacy Practice and Policy, Leiden, The Netherlands.'}, {'ForeName': 'Jeanet W', 'Initials': 'JW', 'LastName': 'Blom', 'Affiliation': 'Department of Public Health and Primary Care, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Jacobijn', 'Initials': 'J', 'LastName': 'Gussekloo', 'Affiliation': 'Department of Public Health and Primary Care, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Marcel L', 'Initials': 'ML', 'LastName': 'Bouvy', 'Affiliation': 'Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences, Utrecht University, The Netherlands.'}]",British journal of clinical pharmacology,['10.1111/bcp.14421'] 1626,32418886,Updated overall survival and final progression-free survival data for patients with treatment-naive advanced ALK-positive non-small-cell lung cancer in the ALEX study.,"BACKGROUND The ALEX study demonstrated significantly improved progression-free survival (PFS) with alectinib versus crizotinib in treatment-naive ALK-positive non-small-cell lung cancer (NSCLC) at the primary data cut-off (9 February 2017). We report mature PFS (cut-off: 30 November 2018) and overall survival (OS) data up to 5 years (cut-off: 29 November 2019). PATIENTS AND METHODS Patients with stage III/IV ALK-positive NSCLC were randomized to receive twice-daily alectinib 600 mg (n = 152) or crizotinib 250 mg (n = 151) until disease progression, toxicity, withdrawal or death. Primary end point: investigator-assessed PFS. Secondary end points included objective response rate, OS and safety. RESULTS Mature PFS data showed significantly prolonged investigator-assessed PFS with alectinib [hazard ratio (HR) 0.43, 95% confidence interval (CI) 0.32-0.58; median PFS 34.8 versus 10.9 months crizotinib]. Median duration of OS follow-up: 48.2 months alectinib, 23.3 months crizotinib. OS data remain immature (37% of events). Median OS was not reached with alectinib versus 57.4 months with crizotinib (stratified HR 0.67, 95% CI 0.46-0.98). The 5-year OS rate was 62.5% (95% CI 54.3-70.8) with alectinib and 45.5% (95% CI 33.6-57.4) with crizotinib, with 34.9% and 8.6% of patients still on study treatment, respectively. The OS benefit of alectinib was seen in patients with central nervous system metastases at baseline [HR 0.58 (95% CI 0.34-1.00)] and those without [HR 0.76 (95% CI 0.45-1.26)]. Median treatment duration was longer with alectinib (28.1 versus 10.8 months), and no new safety signals were observed. CONCLUSIONS Mature PFS data from ALEX confirmed significant improvement in PFS for alectinib over crizotinib in ALK-positive NSCLC. OS data remain immature, with a higher 5-year OS rate with alectinib versus crizotinib. This is the first global randomized study to show clinically meaningful improvement in OS for a next-generation tyrosine kinase inhibitor versus crizotinib in treatment-naive ALK-positive NSCLC. CLINICAL TRIALS NUMBER NCT02075840.",2020,"The 5-year OS rate was 62.5% (95% CI 54.3-70.8) with alectinib and 45.5% (95% CI 33.6-57.4) with crizotinib, with 34.9% and 9.3% of patients still on study treatment, respectively.","['patients with treatment-naïve advanced ALK-positive non-small-cell lung cancer in the ALEX study', 'patients with central nervous system metastases at baseline (HR 0.58', 'Patients with stage III/IV ALK-positive NSCLC']","['twice-daily alectinib 600 mg (n = 152) or crizotinib', 'alectinib versus crizotinib']","['overall survival (OS) data', 'Median duration of OS', 'Median OS', 'Updated overall survival and final progression-free survival data', 'Median treatment duration', 'objective response rate, OS and safety', '5-year OS rate', 'progression-free survival (PFS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C1663627', 'cui_str': 'ALK protein, human'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0279130', 'cui_str': 'CNS metastases'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C4517463', 'cui_str': '0.58'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3'}]","[{'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C3853921', 'cui_str': 'alectinib'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C2974289', 'cui_str': 'crizotinib'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0444921', 'cui_str': 'Duration of treatment'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}]",,0.315613,"The 5-year OS rate was 62.5% (95% CI 54.3-70.8) with alectinib and 45.5% (95% CI 33.6-57.4) with crizotinib, with 34.9% and 9.3% of patients still on study treatment, respectively.","[{'ForeName': 'T', 'Initials': 'T', 'LastName': 'Mok', 'Affiliation': 'State Key Laboratory of Translational Oncology, Chinese University of Hong Kong, Shatin, NT, Hong Kong.'}, {'ForeName': 'D R', 'Initials': 'DR', 'LastName': 'Camidge', 'Affiliation': 'University of Colorado, Denver, USA.'}, {'ForeName': 'S M', 'Initials': 'SM', 'LastName': 'Gadgeel', 'Affiliation': 'Department of Internal Medicine, Rogel Cancer Center/University of Michigan, Ann Arbor, USA.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Rosell', 'Affiliation': 'Catalan Institute of Oncology, Barcelona, Spain.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Dziadziuszko', 'Affiliation': 'Department of Oncology and Radiotherapy, Medical University of Gdansk, Gdansk, Poland.'}, {'ForeName': 'D-W', 'Initials': 'DW', 'LastName': 'Kim', 'Affiliation': 'Seoul National University Hospital, Seoul, South Korea.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Pérol', 'Affiliation': 'Department of Medical Oncology, Léon Bérard Cancer Center, Lyon, France.'}, {'ForeName': 'S-H I', 'Initials': 'SI', 'LastName': 'Ou', 'Affiliation': 'Chao Family Comprehensive Cancer Center, University of California, Irvine, USA.'}, {'ForeName': 'J S', 'Initials': 'JS', 'LastName': 'Ahn', 'Affiliation': 'Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea.'}, {'ForeName': 'A T', 'Initials': 'AT', 'LastName': 'Shaw', 'Affiliation': 'Massachusetts General Hospital, Boston, USA.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Bordogna', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Smoljanović', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Hilton', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Ruf', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Noé', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Peters', 'Affiliation': 'Lausanne University Hospital, Centre Hospitalier Universitaire Vaudois (CHUV), Lausanne, Switzerland. Electronic address: solange.peters@chuv.ch.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1016/j.annonc.2020.04.478'] 1627,32497491,"Tail-phase safety, tolerability, and pharmacokinetics of long-acting injectable cabotegravir in HIV-uninfected adults: a secondary analysis of the HPTN 077 trial.","BACKGROUND Long-acting injectable cabotegravir is a novel integrase inhibitor currently in advanced clinical development for HIV prevention and treatment. We aimed to assess the terminal phase pharmacokinetics and safety of long-acting injectable cabotegravir in participants included in the HPTN 077 trial. METHODS HPTN 077 was a multicentre, double-blind, randomised, placebo-controlled phase 2a trial done at eight sites in Brazil, Malawi, South Africa, and the USA. Participants (aged 18-65 years), who were HIV-uninfected and at low-risk for HIV, were randomly assigned (3:1) to long-acting injectable cabotegravir (800 mg given three times at 12 week intervals or 600 mg given five times, administered at one 4 week interval, and every 8 weeks thereafter) or placebo. Participants were followed up to 76 weeks after final injection. In a prespecified analysis of secondary and exploratory outcomes, we assessed the safety, measured by the proportion of participants with grade 2 or worse adverse events, and pharmacokinetics, measured by apparent terminal phase half-life (t 1/2app ) and estimated time to lower limit of quantification (LLOQ) of long-acting injectable cabotegravir during the injection phase (defined as the time between first injection and 12 weeks or 8 weeks after the last injection in cohort 1 or cohort 2 respectively) and tail phase (defined as the time between final injection and 52-76 weeks post-final injection). Safety was analysed in all participants who received at least one injection. Pharmacokinetic analyses included all participants who had received at least one injection and had at least three cabotegravir measurements higher than the LLOQ after the final injection. Pharmacokinetic outcomes were estimated using non-compartmental methods. The trial is completed, and was registered with ClinicalTrials.gov, NCT02178800. FINDINGS Between Feb 9, 2015, and May 27, 2016, 177 participants (134 participants in the cabotegravir group [74 participants in cohort 1; 60 participants in cohort 2] and 43 participants in the placebo group [25 participants in cohort 1; 18 participants in cohort 2) were enrolled and received at least one injection and thus were included in the safety analysis. The incidence of grade 2 or worse adverse events was significantly lower during the tail phase than the injection phase (p<0·0001). At 52-60 weeks after final injection, nine (23%) of 40 male participants had detectable cabotegravir concentrations and at week 76, four (13%) of 30 male participants had detectable cabotegravir concentrations compared with 52 (63%) of 82 female participants and 27 (42%) of 64 female participants at the same timepoints. The median time from the last injection to the time when cabotegravir concentration decreased below the LLOQ was 43·7 weeks (IQR 31·1-66·6; range 20·4-152·5) for male participants and 67·3 weeks (29·1-89·6; 17·7-225·5) for female participants (p=0·0003). t 1/2app was longer for female participants than male participants (geometric mean fold-change 1·33, 95% CI 1·06-1·68; p=0·014), and longer for participants with a high body-mass index (BMI) than those with a low BMI (1·31, 1·06-1·63; p=0·015). INTERPRETATION The clinical significance of the long pharmacokinetic tail of cabotegravir observed in female participants compared with male participants, and those with higher BMI compared with a lower BMI, need to be addressed in future trials. FUNDING National Institute of Allergy and Infectious Diseases.",2020,The incidence of grade 2 or worse adverse events was significantly lower during the tail phase than the injection phase (p<0·0001).,"['Participants (aged 18-65 years), who were HIV-uninfected and at low-risk for HIV', 'participants who had received at least one injection and had at least three cabotegravir measurements higher than the LLOQ after the final injection', '82 female participants and 27 (42%) of 64 female participants at the same timepoints', 'HIV-uninfected adults', 'participants included in the HPTN 077 trial', 'Between Feb 9, 2015, and May 27, 2016, 177 participants (134 participants in the cabotegravir group [74 participants in cohort 1; 60 participants in cohort 2] and 43 participants in the placebo group [25 participants in cohort 1; 18 participants in cohort 2', 'female participants compared with male participants']","['long-acting injectable cabotegravir', 'placebo']","['Safety', 'Pharmacokinetic outcomes', 'median time', 'detectable cabotegravir concentrations', 'cabotegravir concentration', 'Tail-phase safety, tolerability, and pharmacokinetics', 'incidence of grade 2 or worse adverse events', 'proportion of participants with grade 2 or worse adverse events, and pharmacokinetics, measured by apparent terminal phase half-life (t 1/2app ) and estimated time to lower limit of quantification (LLOQ) of long-acting injectable cabotegravir']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C4517565', 'cui_str': '134'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0086466', 'cui_str': 'Injectable Product'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0039259', 'cui_str': 'Tail'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0475270', 'cui_str': 'G2 grade'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0018517', 'cui_str': 'Halflife'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0086466', 'cui_str': 'Injectable Product'}]",40.0,0.577418,The incidence of grade 2 or worse adverse events was significantly lower during the tail phase than the injection phase (p<0·0001).,"[{'ForeName': 'Raphael J', 'Initials': 'RJ', 'LastName': 'Landovitz', 'Affiliation': 'UCLA Center for Clinical AIDS Research and Education, Division of Infectious Diseases, David Geffen School of Medicine at UCLA, Los Angeles, CA, USA. Electronic address: rlandovitz@mednet.ucla.edu.'}, {'ForeName': 'Sue', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'Statistical Center for HIV/AIDS Research and Prevention, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Joseph J', 'Initials': 'JJ', 'LastName': 'Eron', 'Affiliation': 'University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Grinsztejn', 'Affiliation': 'Evandro Chagas National Institute of Infectious Diseases, Oswaldo Cruz Foundation, Rio de Janeiro, Brazil.'}, {'ForeName': 'Halima', 'Initials': 'H', 'LastName': 'Dawood', 'Affiliation': 'Centre for the AIDS Programme of Research in South Africa, University of KwaZulu Natal, Durban, South Africa.'}, {'ForeName': 'Albert Y', 'Initials': 'AY', 'LastName': 'Liu', 'Affiliation': 'Bridge HIV, Population Health Division, San Francisco Department of Health, San Francisco, CA, USA.'}, {'ForeName': 'Manya', 'Initials': 'M', 'LastName': 'Magnus', 'Affiliation': 'Department of Epidemiology, Milken Institute School of Public Health at The George Washington University, Washington, DC, USA.'}, {'ForeName': 'Mina C', 'Initials': 'MC', 'LastName': 'Hosseinipour', 'Affiliation': 'University of North Carolina Project-Malawi, Lilongwe, Malawi.'}, {'ForeName': 'Ravindre', 'Initials': 'R', 'LastName': 'Panchia', 'Affiliation': 'Perinatal HIV Research Unit, Chris Hani Baragwanath Hospital, Soweto, South Africa.'}, {'ForeName': 'Leslie', 'Initials': 'L', 'LastName': 'Cottle', 'Affiliation': 'Statistical Center for HIV/AIDS Research and Prevention, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Gordon', 'Initials': 'G', 'LastName': 'Chau', 'Affiliation': 'Statistical Center for HIV/AIDS Research and Prevention, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Richardson', 'Affiliation': 'School of Medicine, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Marzinke', 'Affiliation': 'School of Medicine, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Susan H', 'Initials': 'SH', 'LastName': 'Eshleman', 'Affiliation': 'School of Medicine, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Kofron', 'Affiliation': 'UCLA Center for Clinical AIDS Research and Education, Division of Infectious Diseases, David Geffen School of Medicine at UCLA, Los Angeles, CA, USA.'}, {'ForeName': 'Adeola', 'Initials': 'A', 'LastName': 'Adeyeye', 'Affiliation': 'Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, MD, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Burns', 'Affiliation': 'Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, MD, USA.'}, {'ForeName': 'Alex R', 'Initials': 'AR', 'LastName': 'Rinehart', 'Affiliation': 'ViiV Healthcare, Durham, NC, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Margolis', 'Affiliation': 'ViiV Healthcare, Durham, NC, USA.'}, {'ForeName': 'Myron S', 'Initials': 'MS', 'LastName': 'Cohen', 'Affiliation': 'University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Marybeth', 'Initials': 'M', 'LastName': 'McCauley', 'Affiliation': 'FHI 360, Washington, DC, USA.'}, {'ForeName': 'Craig W', 'Initials': 'CW', 'LastName': 'Hendrix', 'Affiliation': 'School of Medicine, Johns Hopkins University, Baltimore, MD, USA.'}]",The lancet. HIV,['10.1016/S2352-3018(20)30106-5'] 1628,32502775,"Lumbar plexus block versus suprainguinal fascia iliaca block for total hip arthroplasty: A single-blinded, randomized trial.","STUDY OBJECTIVE Comparison of ultrasound-guided lumbar plexus block (LPB) and suprainguinal fascia iliaca block (SIFIB) in patients undergoing total hip arthroplasty (THA). DESIGN Randomized equivalence trial. SETTING University Hospital. PATIENTS Sixty patients undergoing primary THA. INTERVENTIONS Patients were randomly allocated to receive ultrasound-guided LPB (n = 30) or SIFIB (n = 30). The local anesthetic agent (40 mL of levobupivacaine 0.25% with epinephrine 5 μg/mL) and block adjuvant (4 mg of intravenous dexamethasone) were identical in all subjects. Postoperatively, all patients received patient-controlled intravenous analgesia (morphine) as well as acetaminophen and ketoprofen during 48 h. MEASUREMENTS A blinded investigator recorded morphine consumption at 24 and 48 h as well as time to first morphine request, pain scores at 3, 6, 12, 24 and 48 h, incidence of adverse events, time to readiness for discharge, and length of hospital stay. The blinded investigator also carried out sensorimotor block assessment at 3, 6 and 24 h using a 10-point sensorimotor composite scale. MAIN RESULTS No intergroup differences were found in terms of cumulative morphine consumption at 24 h (95% CI: -4.0 mg to 2.0 mg) and 48 h (95% CI, -5.0 mg to 2.0 mg) or time to first morphine request. Furthermore, pain scores were similar at all time intervals after 3 h. There were no intergroup differences in terms of composite sensorimotor scores at 3 and 6 h. However, SIFIB lasted longer than lumbar plexus block as evidenced by a higher composite score at 24 h. No intergroup differences were found in terms of complications. Compared with LPB, SIFIB was associated with shorter time to readiness for discharge (3 [1-4] vs. 2 [1-3] days; P = 0.042) and length of hospital stay (3 [2-5] vs. 3 [2-4] days; P = 0.048). CONCLUSIONS For THA, no differences were found between LPB and SIFIB in terms of breakthrough morphine requirement and pain control. However, SIFIB resulted in a longer block and was associated with shorter time to readiness for discharge as well as decreased hospital stay.",2020,No intergroup differences were found in terms of cumulative morphine consumption at 24 h,"['Sixty patients undergoing primary THA', 'University Hospital', 'patients undergoing total hip arthroplasty (THA', 'total hip arthroplasty']","['block adjuvant (4\xa0mg of intravenous dexamethasone', 'acetaminophen and ketoprofen', 'levobupivacaine', 'ultrasound-guided lumbar plexus block (LPB) and suprainguinal fascia iliaca block (SIFIB', 'epinephrine', 'patient-controlled intravenous analgesia (morphine', 'ultrasound-guided LPB', 'Lumbar plexus block versus suprainguinal fascia iliaca block']","['shorter time to readiness for discharge', 'breakthrough morphine requirement and pain control', 'cumulative morphine consumption', 'length of hospital stay', 'complications', 'composite sensorimotor scores', 'adverse events, time to readiness for discharge, and length of hospital stay', 'hospital stay', 'Furthermore, pain scores', 'morphine consumption at 24 and 48\xa0h as well as time to first morphine request, pain scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}]","[{'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0022635', 'cui_str': 'Ketoprofen'}, {'cui': 'C0873118', 'cui_str': 'Levobupivacaine'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0394731', 'cui_str': 'Lumbar plexus block'}, {'cui': 'C0225261', 'cui_str': 'Iliac fascia structure'}, {'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1320402', 'cui_str': 'Readiness for discharge'}, {'cui': 'C0444503', 'cui_str': 'Breakthrough'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C1272683', 'cui_str': 'Requested'}]",60.0,0.130543,No intergroup differences were found in terms of cumulative morphine consumption at 24 h,"[{'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Bravo', 'Affiliation': 'Hospital Clínico Universidad de Chile, Department of Anesthesiology and Perioperative Medicine, University of Chile, Office B222 second floor, sector B, 999 Santos Dumont, Independencia, Santiago, Chile, 8380456. Electronic address: dbravoadvis@uchile.cl.'}, {'ForeName': 'Sebastián', 'Initials': 'S', 'LastName': 'Layera', 'Affiliation': 'Hospital Clínico Universidad de Chile, Department of Anesthesiology and Perioperative Medicine, University of Chile, Office B222 second floor, sector B, 999 Santos Dumont, Independencia, Santiago, Chile, 8380456.'}, {'ForeName': 'Julián', 'Initials': 'J', 'LastName': 'Aliste', 'Affiliation': 'Hospital Clínico Universidad de Chile, Department of Anesthesiology and Perioperative Medicine, University of Chile, Office B222 second floor, sector B, 999 Santos Dumont, Independencia, Santiago, Chile, 8380456.'}, {'ForeName': 'Álvaro', 'Initials': 'Á', 'LastName': 'Jara', 'Affiliation': 'Hospital Clínico Universidad de Chile, Department of Anesthesiology and Perioperative Medicine, University of Chile, Office B222 second floor, sector B, 999 Santos Dumont, Independencia, Santiago, Chile, 8380456.'}, {'ForeName': 'Diego', 'Initials': 'D', 'LastName': 'Fernández', 'Affiliation': 'Hospital Clínico Universidad de Chile, Department of Anesthesiology and Perioperative Medicine, University of Chile, Office B222 second floor, sector B, 999 Santos Dumont, Independencia, Santiago, Chile, 8380456.'}, {'ForeName': 'Cristián', 'Initials': 'C', 'LastName': 'Barrientos', 'Affiliation': 'Hospital Clínico Universidad de Chile, Department of Orthopedic Surgery, University of Chile, Third floor, sector B, 999 Santos Dumont, Independencia, Santiago 8380456, Chile.'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Wulf', 'Affiliation': 'Hospital Clínico Universidad de Chile, Department of Orthopedic Surgery, University of Chile, Third floor, sector B, 999 Santos Dumont, Independencia, Santiago 8380456, Chile.'}, {'ForeName': 'Gonzalo', 'Initials': 'G', 'LastName': 'Muñoz', 'Affiliation': 'Hospital Clínico Universidad de Chile, Department of Anesthesiology and Perioperative Medicine, University of Chile, Office B222 second floor, sector B, 999 Santos Dumont, Independencia, Santiago, Chile, 8380456.'}, {'ForeName': 'Roderick J', 'Initials': 'RJ', 'LastName': 'Finlayson', 'Affiliation': 'Montreal General Hospital, Department of Anesthesiology, McGill University, 1650 Ave Cedar, D10-D144, Montreal, Quebec H3G-1A4, Canada.'}, {'ForeName': 'De Q', 'Initials': 'Q', 'LastName': 'Tran', 'Affiliation': ""St. Mary's Hospital, Department of Anesthesiology, McGill University, 3830 Ave Lacombe, Montreal, Quebec H3T-1M5, Canada.""}]",Journal of clinical anesthesia,['10.1016/j.jclinane.2020.109907'] 1629,32502795,Comparison of underwater gait training and overground gait training for improving the walking and balancing ability of patients with severe hemiplegic stroke: A randomized controlled pilot trial.,"BACKGROUND Walking training is an essential intervention to improve the function in stroke patients. However, only a limited number of gait training strategies are available for stroke patients with relatively severe disabilities. RESEARCH QUESTION Is underwater gait training or overground gait training more effective in severe stroke patients? METHODS A total of 21 patients with severe hemiplegic stroke were randomly assigned to the experimental and control groups. All participants (n = 21) received 60-minute sessions of general physical therapy, 5 times a week for a period of 12 weeks. Additionally, the experimental and control groups underwent underwater and overground walking training, respectively, for 30 min twice times a week for 12 weeks. Postural assessment for stroke score, center of pressure path length and velocity, step time and step length difference, and walking velocity were measured before and after the 12-week training. RESULTS Both groups showed a significant decrease in the center of pressure path length and velocity after the intervention compared to the values before the intervention (p < .05). However, there was no significant difference in the center of pressure path length and velocity changes after training between the two groups (p > .05). In the walking variables, the step length difference changes after training between the two groups showed a significant difference (p < .05). In the experimental group, the step length difference increased after the intervention compared to that before the intervention (+4.55 cm), whereas that of the control group decreased (-1.25 cm). SIGNIFICANCE In severe stroke patients, underwater gait training can be effective for improving balancing ability, but it may be less effective on the improvement of gait function than overground walking. CLINICAL TRIAL REGISTRATION NUMBER KCT0002587 (https://cris.nih.go.kr).",2020,"However, there was no significant difference in the center of pressure path length and velocity changes after training between the two groups (p > .05).","['21 patients with severe hemiplegic stroke', 'stroke patients', 'severe stroke patients', 'stroke patients with relatively severe disabilities', 'patients with severe hemiplegic stroke']","['Walking training', 'underwater gait training', '60-minute sessions of general physical therapy', 'underwater and overground walking training', 'underwater gait training and overground gait training', 'underwater gait training or overground gait training']","['center of pressure path length and velocity', 'Postural assessment for stroke score, center of pressure path length and velocity, step time and step length difference, and walking velocity', 'gait function', 'center of pressure path length and velocity changes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0231170', 'cui_str': 'Disability'}]","[{'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0085673', 'cui_str': 'Gait training procedure'}, {'cui': 'C3853333', 'cui_str': 'Sixty minutes'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}]","[{'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0205278', 'cui_str': 'Postural'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0427126', 'cui_str': 'Step length'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",21.0,0.0299419,"However, there was no significant difference in the center of pressure path length and velocity changes after training between the two groups (p > .05).","[{'ForeName': 'Nan-Hyang', 'Initials': 'NH', 'LastName': 'Kim', 'Affiliation': 'Department of Physical Therapy, Graduate School of Daejeon University, Republic of Korea. Electronic address: kimnan1004@hanmail.net.'}, {'ForeName': 'Hoon-Young', 'Initials': 'HY', 'LastName': 'Park', 'Affiliation': 'Department of Physical Therapy, Graduate School of Daejeon University, Republic of Korea. Electronic address: phy9234@naver.com.'}, {'ForeName': 'Jin-Kyu', 'Initials': 'JK', 'LastName': 'Son', 'Affiliation': 'Department of Physical Therapy, College of Health and Medical Science, Daejeon University, Republic of Korea. Electronic address: thswlsrb1004@naver.com.'}, {'ForeName': 'Young', 'Initials': 'Y', 'LastName': 'Moon', 'Affiliation': 'Department of Physical Therapy, Graduate School of Daejeon University, Republic of Korea. Electronic address: moyo2ng@naver.com.'}, {'ForeName': 'Jun-Ho', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': 'Department of Emergency Medical Technology, College of Health and Medical Science, Daejeon University, Republic of Korea. Electronic address: jhlee@dju.kr.'}, {'ForeName': 'Yong-Jun', 'Initials': 'YJ', 'LastName': 'Cha', 'Affiliation': 'Department of Physical Therapy, College of Health and Medical Science, Daejeon University, Republic of Korea. Electronic address: cha0874@dju.kr.'}]",Gait & posture,['10.1016/j.gaitpost.2020.05.022'] 1630,32504694,Forty-eight-hour fasting declines mental flexibility but improves balance in overweight and obese older women.,"The purpose of this study was to investigate the effects of a 48-h fast on evoked stress, mood, and cognitive and motor functions in overweight and obese older women. Eleven women (body mass index >25 kg/m 2 ) aged 63-80 years were tested under two randomly allocated conditions: 48-h zero-calorie diet with water provided ad libitum and 48-h usual diet. Autonomic function, cortisol levels, mood state, cognitive performance, visuomotor coordination, motor speed, and balance were evaluated before and after each diet. Fasting increased (P < 0.05) cortisol levels, whereas no changes were observed in heart rate and its variability. Fasting increased (P < 0.05) fatigue, prolonged (P < 0.05) reaction time in the two-choice reaction time test and decreased (P < 0.05) the velocity vector of the center of pressure with eyes closed, whereas no changes in performance were observed in the pursuit tracking and finger tapping tests. Thus, although a 48-h fast resulted in greater hypothalamic-pituitary-adrenal axis activity in overweight and obese older women, autonomic nervous system activity was not affected. Fasting increased fatigue and decreased mental flexibility, but improved balance.",2020,"Fasting increased (P < 0.05) fatigue, prolonged (P < 0.05) reaction time in the two-choice reaction time test and decreased (P < 0.05) the velocity vector of the center of pressure with eyes closed, whereas no changes in performance were observed in the pursuit tracking and finger tapping tests.","['Eleven women (body mass index >25 kg/m 2 ) aged 63-80 years', 'overweight and obese older women']",['48-h zero-calorie diet with water provided ad libitum and 48-h usual diet'],"['evoked stress, mood, and cognitive and motor functions', 'Autonomic function, cortisol levels, mood state, cognitive performance, visuomotor coordination, motor speed, and balance', 'reaction time', 'Fasting increased fatigue and decreased mental flexibility', 'autonomic nervous system activity', 'cortisol levels', 'heart rate and its variability', 'pursuit tracking and finger tapping tests', 'hypothalamic-pituitary-adrenal axis activity', 'Fasting']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0919414', 'cui_str': '0'}, {'cui': 'C0301589', 'cui_str': 'Calorie diet'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}]","[{'cui': 'C1444748', 'cui_str': 'Evoked'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0234130', 'cui_str': 'Motor function'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0242414', 'cui_str': 'Coordination'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0016129', 'cui_str': 'Digit of hand structure'}, {'cui': 'C0034115', 'cui_str': 'Centesis'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0020663', 'cui_str': 'Hypothalamic structure'}, {'cui': 'C0032022', 'cui_str': 'Pituitary-Adrenal System'}]",,0.0141728,"Fasting increased (P < 0.05) fatigue, prolonged (P < 0.05) reaction time in the two-choice reaction time test and decreased (P < 0.05) the velocity vector of the center of pressure with eyes closed, whereas no changes in performance were observed in the pursuit tracking and finger tapping tests.","[{'ForeName': 'Rima', 'Initials': 'R', 'LastName': 'Solianik', 'Affiliation': 'Institute of Sports Science and Innovations, Lithuanian Sports University, Sporto str. 6, LT-44221 Kaunas, Lithuania. Electronic address: rima.solianik@lsu.lt.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Žlibinaitė', 'Affiliation': 'Institute of Sports Science and Innovations, Lithuanian Sports University, Sporto str. 6, LT-44221 Kaunas, Lithuania.'}, {'ForeName': 'Margarita', 'Initials': 'M', 'LastName': 'Drozdova-Statkevičienė', 'Affiliation': 'Institute of Sports Science and Innovations, Lithuanian Sports University, Sporto str. 6, LT-44221 Kaunas, Lithuania.'}, {'ForeName': 'Artūras', 'Initials': 'A', 'LastName': 'Sujeta', 'Affiliation': 'Institute of Sports Science and Innovations, Lithuanian Sports University, Sporto str. 6, LT-44221 Kaunas, Lithuania.'}]",Physiology & behavior,['10.1016/j.physbeh.2020.112995'] 1631,32506940,Twelve-week intradialytic cycling exercise improves physical functional performance with gain in muscle strength and endurance: a randomized controlled trial.,"OBJECTIVE To evaluate the effect of intradialytic cycling exercise on physical functional performance with gain in muscle strength and endurance in end-stage renal disease patients with haemodialysis. DESIGN Randomized controlled trial, with repeated measurements at baseline and after 4, 8, and 12 weeks of intradialytic cycling exercise. SETTING A 50-bed haemodialysis centre in a regional hospital in Taiwan. SUBJECTS Seventy-six regular haemodialysis patients, recruited and equally and randomly assigned to exercise and control groups. INTERVENTION The intradialytic cycling exercise was performed for 12 weeks and comprised warm-up, main, and cool-down exercise phases. A stationary cycling equipment was used, which involved aerobic and resistance modalities. The intensity was maintained at somewhat hard exertion. Each intradialytic cycling exercise was implemented for 30 minutes, starting at the second hour of treatment. MAIN MEASURE Measured outcomes were 6-minute walk distance, time taken to complete 10 sit-to-stand-to-sit cycles and number of sit-to-stand-to-sit cycles in 60 seconds. RESULTS Average (standard deviation) participant age was 55.47 (13.00) years. Therefore, the 6-minute walk distance was significantly different at weeks 8 ( P  = 0.01) and 12 ( P  < 0.001) in the exercise group compared with that in the control group at baseline. Notably, sit-to-stand-to-sit outcomes ( P  = 0.01) significantly influenced the 6-minute walk distance. Sit-to-stand-to-sit outcomes significantly improved in the exercise group ( P  < 0.05). CONCLUSION Twelve-week intradialytic exercise for patients on haemodialysis can improve physical functional performance with gain muscle strength and endurance. This is a safe and effective method for improving health.",2020,"Sit-to-stand-to-sit outcomes significantly improved in the exercise group ( P  < 0.05). ","['muscle strength and endurance', 'end-stage renal disease patients with haemodialysis', 'Seventy-six regular haemodialysis patients', 'A 50-bed haemodialysis centre in a regional hospital in Taiwan']",['intradialytic cycling exercise'],"['6-minute walk distance, time taken to complete 10 sit-to-stand-to-sit cycles and number of sit-to-stand-to-sit cycles in 60\u2009seconds', '6-minute walk distance', 'Sit-to-stand-to-sit outcomes', 'physical functional performance']","[{'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0022661', 'cui_str': 'Chronic renal failure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C4319622', 'cui_str': '76'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0004914', 'cui_str': 'Bedding'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0039260', 'cui_str': 'Taiwan'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0429886', 'cui_str': 'Walking distance'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0560801', 'cui_str': 'Does stand from sitting'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C4704690', 'cui_str': 'Physical Functional Performance'}]",76.0,0.0517663,"Sit-to-stand-to-sit outcomes significantly improved in the exercise group ( P  < 0.05). ","[{'ForeName': 'Mei-Ling', 'Initials': 'ML', 'LastName': 'Yeh', 'Affiliation': 'School of Nursing, National Taipei University of Nursing and Health Sciences, Taipei.'}, {'ForeName': 'Mei-Hua', 'Initials': 'MH', 'LastName': 'Wang', 'Affiliation': 'National Taipei University of Nursing and Health Sciences, Taipei.'}, {'ForeName': 'Chin-Che', 'Initials': 'CC', 'LastName': 'Hsu', 'Affiliation': 'Heng Chun Christian Hospital, Kaohsiung.'}, {'ForeName': 'Yueh-Min', 'Initials': 'YM', 'LastName': 'Liu', 'Affiliation': 'Ching Kuo Institute of Management and Health, Keelung.'}]",Clinical rehabilitation,['10.1177/0269215520921923'] 1632,32505866,"Compared to Facebook, Instagram use causes more appearance comparison and lower body satisfaction in college women.","The current experiment tested the effect of social media use on college women's appearance comparisons, mood, and body satisfaction. We randomly assigned 308 undergraduate women (aged 18-26) to use Facebook, use Instagram, or play a matching game (the control condition) on an iPad for seven minutes. Compared to the Facebook condition, Instagram users retrospectively reported spending more time viewing images or videos containing people. Participants in both the Facebook and Instagram conditions also retrospectively reported engaging in more appearance comparisons relative to those in the control condition, but Instagram users reported significantly more appearance comparisons than those in the Facebook condition. Those who used Instagram, but not Facebook, showed decreased body satisfaction, decreased positive affect, and increased negative affect. Results are consistent with previous research suggesting social media use influences body satisfaction and social comparison, and that Instagram may be a particularly harmful platform when it comes to body image because of its focus on photos over text.",2020,"Those who used Instagram, but not Facebook, showed decreased body satisfaction, decreased positive affect, and increased negative affect.","[""college women's"", '308 undergraduate women (aged 18-26) to use', 'college women']","['Facebook, use Instagram, or play a matching game (the control condition']","['body satisfaction', 'appearance comparisons, mood, and body satisfaction']","[{'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0042153', 'cui_str': 'utilization'}]","[{'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0026516', 'cui_str': 'Mood'}]",308.0,0.0383295,"Those who used Instagram, but not Facebook, showed decreased body satisfaction, decreased positive affect, and increased negative affect.","[{'ForeName': 'Renee', 'Initials': 'R', 'LastName': 'Engeln', 'Affiliation': 'Department of Psychology, Northwestern University, United States. Electronic address: rengeln@northwestern.edu.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Loach', 'Affiliation': 'Department of Psychology, Northwestern University, United States.'}, {'ForeName': 'Megan N', 'Initials': 'MN', 'LastName': 'Imundo', 'Affiliation': 'Department of Psychology, University of California, Los Angeles, United States.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Zola', 'Affiliation': 'Oxford Internet Institute, University of Oxford, United Kingdom.'}]",Body image,['10.1016/j.bodyim.2020.04.007'] 1633,32505867,Light-emitting-diode and Grass PS 33 xenon lamp photic stimulators are equivalent in the assessment of photosensitivity: Clinical and research implications.,"The assessment of the effect of photic stimulation is an integral component of an EEG exam and is especially important in patients referred for ascertained or suspected photosensitivity with or without a diagnosis of epilepsy. A positive test result relies on eliciting a specific abnormality defined as the ""photoparoxysmal response"". Reliability of this assessment is strongly influenced by technical and procedural variables, a critical one represented by the physical properties of the stimulators used. Established clinical norms are based on data acquired with the ""gold-standard"" Grass PS stimulators. These are no longer commercially available and have been replaced by stimulators using light emitting diode (LED) technology. To our knowledge no comparative study on their efficacy has been conducted. To address this gap, we recruited 39 patients aged 5-54 years, referred to two specialized centers with confirmed of suspected diagnosis of photosensitive epilepsy or generalized epilepsy with photosensitivity in a prospective randomized single-blind cross-over study to compare two commercially available LED-bases stimulation systems (FSA 10® and Lifeline® stimulators) against the Grass PS 33 xenon lamp device. Our findings indicate that the LED systems tested are equivalent to the Grass stimulator both in identifying the PPR in affected individuals.",2020,Our findings indicate that the LED systems tested are equivalent to the Grass stimulator both in identifying the PPR in affected individuals.,"['39 patients aged 5-54 years, referred to two specialized centers with confirmed of suspected diagnosis of photosensitive epilepsy or generalized epilepsy with photosensitivity', 'patients referred for ascertained or suspected photosensitivity with or without a diagnosis of epilepsy']","['Light-emitting-diode and Grass PS 33 xenon lamp photic stimulators', 'LED-bases stimulation systems (FSA 10® and Lifeline® stimulators) against the Grass PS 33 xenon lamp device', 'photic stimulation']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0393720', 'cui_str': 'Photogenic epilepsy'}, {'cui': 'C0014548', 'cui_str': 'Generalized epilepsy'}, {'cui': 'C0349506', 'cui_str': 'Photosensitivity'}, {'cui': 'C0014544', 'cui_str': 'Epilepsy'}]","[{'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0162676', 'cui_str': 'Enzyme-multiplied immunoassay technique'}, {'cui': 'C0018210', 'cui_str': 'Poaceae'}, {'cui': 'C0043339', 'cui_str': 'Xenon'}, {'cui': 'C0392223', 'cui_str': 'Lamp'}, {'cui': 'C0175727', 'cui_str': 'Stimulator'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0031734', 'cui_str': 'Photic stimulation'}]",[],39.0,0.0265254,Our findings indicate that the LED systems tested are equivalent to the Grass stimulator both in identifying the PPR in affected individuals.,"[{'ForeName': 'Dorothée', 'Initials': 'D', 'LastName': 'Kasteleijn-Nolst Trenité', 'Affiliation': 'Department of Neurosurgery and Epilepsy, University Medical Center Utrecht, Utrecht, the Netherlands; Nesmos Department, Faculty of Medicine and Psychology, Sapienza University, Roma, Italy.'}, {'ForeName': 'Bryony', 'Initials': 'B', 'LastName': 'Carr', 'Affiliation': ""Department of Clinical Neurophysiology, Birmingham Women's and Children's Hospital NHS Foundation Trust, Birmingham, UK.""}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Checa-Ros', 'Affiliation': ""Department of Clinical Neurophysiology, Birmingham Women's and Children's Hospital NHS Foundation Trust, Birmingham, UK; School of Life and Health Sciences, Aston Neuroscience Institute, Aston University, Birmingham, UK; Department of Pediatrics, Faculty of Medicine, University of Granada, Spain.""}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Seri', 'Affiliation': ""Department of Clinical Neurophysiology, Birmingham Women's and Children's Hospital NHS Foundation Trust, Birmingham, UK; School of Life and Health Sciences, Aston Neuroscience Institute, Aston University, Birmingham, UK. Electronic address: s.seri@aston.ac.uk.""}]",Epilepsy research,['10.1016/j.eplepsyres.2020.106377'] 1634,32513290,A pilot study of therapeutic plasma exchange for serious SARS CoV-2 disease (COVID-19): A structured summary of a randomized controlled trial study protocol.,"OBJECTIVES To evaluate the safety of therapeutic plasma exchange (TPE) in adult patients with serious/life-threatening COVID-19 requiring intensive care unit (ICU) admission, and associated 28-day mortality. Serious and life threatening COVID-19 are defined as per published literature (please, refer to the full protocol, Additional file 1). The rationale is that TPE can remove interleukins-3, 6, 8, 10, interferon-gamma and tumor necrosis factor-alpha. Thus, it may reduce the cytokine release syndrome associated with fulminant COVID-19 disease. TRIAL DESIGN Pilot, interventional, open-label, randomized controlled multicenter trial. PARTICIPANTS Inclusion criteria are: 1) age ≥ 18 years old; 2) intubation and intensive care unit (ICU) admission; 3) serious and/or life-threatening COVID-19 (please, refer to the full protocol, Additional file 1). SARS-CoV-2 infection is confirmed by Real-Time-Polymerase-Chain-Reaction (RT-PCR) assays using QuantiNova Probe RT-PCR kit (Qiagen) in a Light-Cycler 480 real-time PCR system (Roche, Basel, Switzerland). Exclusion criteria are: 1) previous allergic reaction to plasma exchange or its ingredients (i.e., sodium citrate), 2) two consecutive negative RT-PCR tests for SARS-CoV-2 at least 24 hours apart, 3) mild COVID-19 not requiring ICU admission and 4) terminally ill patients receiving palliative care. The primary site will be King Saud Medical City (KSMC), Riyadh, Kingdom of Saudi Arabia (KSA). Also, the study will run in ICUs (Ministry of Health Cluster 1; Riyadh) and other centers in KSA pending their institutional review board (IRB) approval. INTERVENTIONS AND COMPARATOR The intervention group will receive TPE, plus empiric treatment for COVID-19. TPE is administered using the Spectra Optia TM Apheresis System equipped with the Depuro D2000 Adsorption Cartridge (Terumo BCT Inc., USA). The first dose is 1.5 plasma volumes, followed by one plasma volume on alternate days or daily for five to seven total treatments. Spectra Optia TM Apheresis System operates with acid-citrate dextrose anticoagulant (ACDA) as per Kidney Disease Improving Global Outcomes (KDIGO) 2019 guidelines. Plasma is replaced with albumin 5% or fresh frozen plasma in patients with coagulopathy (prothrombin time >37 seconds; international normalized ratio >3; activated partial thromboplastin time >100 or fibrinogen level <100 mg/d). TPE sessions are performed daily over four hours and laboratory markers measured daily. The comparators are controls not receiving TPE but usual empiric treatment for COVID-19 as per institutional, national and international recommendations. Both groups will receive standard ICU supportive care. MAIN OUTCOMES Primary study end-point is 28-day mortality and safety of TPE in serious and/or life-threatening COVID-19. Safety will be evaluated by the documentation of any pertinent adverse and/or serious adverse effects related to TPE as per institutional, national and international (Food and Drug Administration) guidelines. Secondary outcomes are: i) improvement in Sequential Organ Function Assessment (SOFA) score ; ii) changes in inflammatory markers: serum C-reactive protein, lactate dehydrogenase, ferritin, d-dimers and interleukin-6; iii) days on mechanical ventilation and ICU length of stay. RANDOMIZATION Eligible consented patients are randomized (1:1 allocation) after stratification by ICU center and two PaO2/FIO2 ratio categories (> 150 and ≤ 150). Randomization occurs in variable block sizes of four to eight patients. A web-based randomization service, randomize.net, is used to allocate patients to their respective strata prior to the intervention or control therapy. BLINDING (MASKING) Given the visibility of TPE machinery, the intervention will be unblinded; hence, no enrollment concealment will be expedited. The lack of allocation concealment will be mitigated by several measures (please, refer to the full protocol, Additional file 1). NUMBERS TO BE RANDOMIZED (SAMPLE SIZE) This pilot randomized trial aims to recruit a convenience sample of patients with serious and/or life-threatening COVID-19. Therefore, at least 20 patients are to be randomized to each group per participating center. We are hoping to consent and randomize approximately 60 patients in each group over a 3 to 6 months period giving a total of 120 participants. TRIAL STATUS The protocol version 1 was approved 29/04/2020. Recruitment is ongoing, and began on 01/05/2020. We estimate completion by 29/10/2020. TRIAL REGISTRATION Registered at ISRCTN on 18/05/2020 (ISRCTN21363594; doi.10.1186/ ISRCTN21363594). FULL PROTOCOL The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest of expediting dissemination of this material, the familiar formatting has been eliminated; this letter serves as a summary of the key elements of the full protocol.",2020,"SARS-CoV-2 infection is confirmed by Real-Time-Polymerase-Chain-Reaction (RT-PCR) assays using QuantiNova Probe RT-PCR kit (Qiagen) in a Light-Cycler 480 real-time PCR system (Roche, Basel, Switzerland).","['Exclusion criteria are: 1) previous allergic reaction to plasma exchange or its ingredients (i.e., sodium citrate), 2) two consecutive negative RT-PCR tests for SARS-CoV-2 at least 24 hours apart, 3) mild COVID-19 not requiring ICU admission and 4) terminally ill patients receiving palliative care', 'Inclusion criteria are: 1) age ≥ 18 years old; 2) intubation and intensive care unit (ICU) admission; 3) serious and/or life-threatening COVID-19 (please, refer to the full protocol, Additional file 1', '60 patients in each group over a 3 to 6 months period giving a total of 120 participants', 'serious SARS CoV-2 disease (COVID-19', 'patients with serious and/or life-threatening COVID-19', 'adult patients with serious/life-threatening COVID-19 requiring intensive care unit (ICU) admission, and associated 28-day mortality']","['TPE', 'acid-citrate dextrose anticoagulant (ACDA', 'TPE, plus empiric treatment for COVID-19', 'therapeutic plasma exchange (TPE']","['28-day mortality and safety of TPE in serious and/or life-threatening COVID-19', 'i) improvement in Sequential Organ Function Assessment (SOFA) score ; ii) changes in inflammatory markers: serum C-reactive protein, lactate dehydrogenase, ferritin, d-dimers and interleukin-6; iii) days on mechanical ventilation and ICU length of stay']","[{'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0032113', 'cui_str': 'Plasma exchange'}, {'cui': 'C0142825', 'cui_str': 'sodium citrate'}, {'cui': 'C0205448', 'cui_str': '2'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0599161', 'cui_str': 'Polymerase Chain Reaction, Reverse Transcriptase'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C1097282', 'cui_str': '2-amino-5-(3,4-dimethoxyphenyl)-1,3,4-thiadiazole'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0039552', 'cui_str': 'Terminally Ill'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030231', 'cui_str': 'Palliative care'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C3537125', 'cui_str': 'Common terminology criteria for adverse events grade 4'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0016094', 'cui_str': 'Filing'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]","[{'cui': 'C0032113', 'cui_str': 'Plasma exchange'}, {'cui': 'C0050552', 'cui_str': 'acid citrate dextrose'}, {'cui': 'C0003280', 'cui_str': 'Anticoagulant'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0749647', 'cui_str': 'Empiric treatment'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0032113', 'cui_str': 'Plasma exchange'}, {'cui': 'C3537125', 'cui_str': 'Common terminology criteria for adverse events grade 4'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C4758616', 'cui_str': 'Assessment score'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0202113', 'cui_str': 'Lactate dehydrogenase measurement'}, {'cui': 'C0015879', 'cui_str': 'Ferritin'}, {'cui': 'C0060323', 'cui_str': 'D-dimer'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}]",120.0,0.272786,"SARS-CoV-2 infection is confirmed by Real-Time-Polymerase-Chain-Reaction (RT-PCR) assays using QuantiNova Probe RT-PCR kit (Qiagen) in a Light-Cycler 480 real-time PCR system (Roche, Basel, Switzerland).","[{'ForeName': 'Fahad', 'Initials': 'F', 'LastName': 'Faqihi', 'Affiliation': 'Critical Care Department, King Saud Medical City, Riyadh, Kingdom of Saudi Arabia.'}, {'ForeName': 'Abdulrahman', 'Initials': 'A', 'LastName': 'Alharthy', 'Affiliation': 'Critical Care Department, King Saud Medical City, Riyadh, Kingdom of Saudi Arabia.'}, {'ForeName': 'Mohammed', 'Initials': 'M', 'LastName': 'Alodat', 'Affiliation': 'Critical Care Department, King Saud Medical City, Riyadh, Kingdom of Saudi Arabia.'}, {'ForeName': 'Daood', 'Initials': 'D', 'LastName': 'Asad', 'Affiliation': 'Critical Care Department, King Saud Medical City, Riyadh, Kingdom of Saudi Arabia.'}, {'ForeName': 'Waleed', 'Initials': 'W', 'LastName': 'Aletreby', 'Affiliation': 'Critical Care Department, King Saud Medical City, Riyadh, Kingdom of Saudi Arabia.'}, {'ForeName': 'Demetrios J', 'Initials': 'DJ', 'LastName': 'Kutsogiannis', 'Affiliation': 'Department of Critical Care, Faculty of Medicine and Dentistry, The University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Peter G', 'Initials': 'PG', 'LastName': 'Brindley', 'Affiliation': 'Department of Critical Care, Faculty of Medicine and Dentistry, The University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Dimitrios', 'Initials': 'D', 'LastName': 'Karakitsos', 'Affiliation': 'Critical Care Department, King Saud Medical City, Riyadh, Kingdom of Saudi Arabia. karakitsosdimitrios@gmail.com.'}]",Trials,['10.1186/s13063-020-04454-4'] 1635,32513299,"Efficacy and safety of Anluohuaxian in the treatment of patients with severe Coronavirus disease 2019- a multicenter, open label, randomized controlled study: a structured summary of a study protocol for a randomised controlled trial.","OBJECTIVES Patients with severe COVID-19 often suffer from significant pulmonary fibrosis. Although the pathogenesis of pulmonary fibrosis has not been fully explained, the signal pathways and cytokines involved are very similar to hepatic fibrosis. This has been successfully treated with the Anluohuaxian Pill, a proprietary Chinese medicine composed of a variety of Chinese herbal medicines. The aim of this study is to evaluate the efficacy and safety of Anluohuaxian in the treatment of pulmonary fibrosis in patients with severe COVID-19. TRIAL DESIGN This is a prospective, multicenter, open, randomized controlled trial. The distribution ratio was 2:1, 500 cases in the experimental group and 250 cases in the control group. PARTICIPANTS Minimum Age: 18 Years Maximum Age: 80 Years Sex: All Gender Based: No Accepts Healthy Volunteers: No Inclusion Criteria: 1.Confirmed COVID-19, and the nucleic acid test of respiratory specimens such as sputum or nasopharyngeal swabs is negative twice after the treatment (sampling interval is at least 24 hours);2.Negative nucleic acid test of respiratory specimens such as sputum or nasopharyngeal swabs during screening visits;3.High-resolution CT of the lung (HRCT) indicates pulmonary fibrosis (thickness of lobular septum, honeycomb-like changes, with or without bronchial / pleural distraction);4.Voluntarily participate in research and sign informed consent. EXCLUSION CRITERIA 1.Combined with severe heart, lung (diagnosed with interstitial lung disease, bronchial asthma, chronic obstructive pulmonary disease, etc.), liver and kidney disease or with endocrine, rheumatic, neurologic, malignant and other systemic diseases;2.Have been diagnosed with connective tissue disease;3.Pregnant or lactating women;4.History of mental disorders, substance abuse or dependence;5.Have used other anti-pulmonary fibrosis drugs in the past 14 days, such as nintedanib, pirfenidone, penicillamine, colchicine, tumor necrosis factor alpha blocker, imatinib, glucocorticoid hormones, morphomycodyl esters, azathioprine, cyclophosphamide, interferon-γ, and traditional Chinese medicine;6.Researchers consider it inappropriate to participate in research;7.Participating in other clinical research. This mutli-centre RCT will be undertaken in 9 trial centres: The Second People's Hospital of Fuyang, Ezhou Central Hospital, Huoshenshan Hospital of Wuhan, Jinyintan Hospital of Wuhan, Tongji Hospital of Huazhong University of Science and Technology, West Hospital Union Hospital Huazhong University of Science and Technology, Wuhan Pulmonary Hospital, Zhongnan Hospital of Wuhan University, Wenzhou Medical University Affiliated First Hospital. INTERVENTION AND COMPARATOR The research drug is Anluohuaxian Pill, which is provided by Senlong Pharmaceutical Co., Ltd. The basic therapeutic drugs for COVID-19 involved in the study include antiviral drugs. Brands can be selected according to the treatment routines of each research center to facilitate the improvement of treatment compliance. MAIN OUTCOMES Primary Outcome Measure: 1.Changes in high-resolution computer tomography of the lung Changes in ground-glass shadows, interstitial or air nodules found on high-resolution computer tomography [Time Frame: 3 months] 2.Change in 6-minute walking distance [Time Frame: 3 months] RANDOMISATION: In this study, the central randomization system (IWRS, an interactive network response system based on network) is used to randomise the groups. The subjects who met the entry criteria were randomly divided into the experimental group and the control group according to the proportion of 2:1. In this study, the block randomized grouping method is used, and the block length is 6. The random grouping program is set up by statistical and computer professionals in the randomization process. BLINDING (MASKING) This is an open label trial. Trial participants, investigators, care givers, outcome assessors, and date analysts are not blinded to group assignment. NUMBERS TO BE RANDOMISED (SAMPLE SIZE) 750 patients are expected to be enrolled and the cases are allocated according to the ratio of 2 (Anluohuaxian combined with regular treatment group):1 (regular treatment group). TRIAL STATUS Protocol version number 3.0, 10th April 2020. The recruitment has not yet started. Actual Study Start Date: April 1, 2020 Estimated Primary Completion Date: June 1, 2020 Estimated Study Completion Date: December 1, 2020 TRIAL REGISTRATION: ClinicalTrials.gov ID: NCT04334265. Registered on 3 April 2020 FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.",2020,is negative twice after the treatment,"['subjects who met the entry criteria', 'patients with severe Coronavirus disease 2019- a multicenter', 'Patients with severe COVID-19 often suffer from significant pulmonary fibrosis', 'Registered on 3 April 2020', '1.Combined with severe heart, lung (diagnosed with interstitial lung disease, bronchial asthma, chronic obstructive pulmonary disease, etc.), liver and kidney disease or with endocrine, rheumatic, neurologic, malignant and other systemic diseases;2.Have been diagnosed with connective tissue disease;3.Pregnant or lactating women;4.History of mental disorders, substance abuse or', 'Protocol version number 3.0, 10th April 2020', 'Minimum Age: 18 Years Maximum Age', ""9 trial centres: The Second People's Hospital of Fuyang, Ezhou Central Hospital, Huoshenshan Hospital of Wuhan, Jinyintan Hospital of Wuhan, Tongji Hospital of Huazhong University of Science and Technology, West Hospital Union Hospital Huazhong University of Science and Technology, Wuhan Pulmonary Hospital, Zhongnan Hospital of Wuhan University, Wenzhou Medical University Affiliated First Hospital"", '750 patients', 'Healthy Volunteers', '2020 Estimated Primary Completion Date: June 1, 2020 Estimated Study Completion Date: December 1, 2020 TRIAL REGISTRATION', 'patients with severe COVID-19', '80 Years Sex']","['Anluohuaxian', 'azathioprine, cyclophosphamide, interferon-γ', 'Anluohuaxian combined with regular treatment group):1 (regular treatment group', 'dependence;5.Have']","['distribution ratio', 'efficacy and safety', 'Efficacy and safety', '6-minute walking distance']","[{'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0034069', 'cui_str': 'Fibrosis of lung'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0206062', 'cui_str': 'Interstitial lung disease'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0022658', 'cui_str': 'Kidney disease'}, {'cui': 'C0014136', 'cui_str': 'Structure of endocrine system'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0205282', 'cui_str': 'Malignant'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0009780', 'cui_str': 'Connective tissue'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0740858', 'cui_str': 'Substance abuse'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0036397', 'cui_str': 'Science'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0037769', 'cui_str': 'West syndrome'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C4517868', 'cui_str': '750'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0011008', 'cui_str': 'Date'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}]","[{'cui': 'C0004482', 'cui_str': 'Azathioprine'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0012751', 'cui_str': 'Distance'}]",,0.0859004,is negative twice after the treatment,"[{'ForeName': 'Chi', 'Initials': 'C', 'LastName': 'Zhang', 'Affiliation': 'Department of Infectious Disease, Center for Liver Disease, Peking University First Hospital, No.8 Xishiku Street, Xicheng District, Beijing, China.'}, {'ForeName': 'Jiawen', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Infectious Disease, Center for Liver Disease, Peking University First Hospital, No.8 Xishiku Street, Xicheng District, Beijing, China.'}, {'ForeName': 'Zhao', 'Initials': 'Z', 'LastName': 'Wu', 'Affiliation': 'Department of Infectious Disease, Center for Liver Disease, Peking University First Hospital, No.8 Xishiku Street, Xicheng District, Beijing, China.'}, {'ForeName': 'He', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Department of Radiology, Peking University First Hospital, No. 8 Xishiku Street, Xicheng District, Beijing, 100034, China.'}, {'ForeName': 'Chengli', 'Initials': 'C', 'LastName': 'Que', 'Affiliation': 'Department of Respiratory Disease, Peking University First Hospital, No. 8 Xishiku Street, Xicheng District, Beijing, 100034, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Zhao', 'Affiliation': 'Department of Infectious Disease, Center for Liver Disease, Peking University First Hospital, No.8 Xishiku Street, Xicheng District, Beijing, China. zhaohong_pufh@bjmu.edu.cn.'}, {'ForeName': 'Guiqiang', 'Initials': 'G', 'LastName': 'Wang', 'Affiliation': 'Department of Infectious Disease, Center for Liver Disease, Peking University First Hospital, No.8 Xishiku Street, Xicheng District, Beijing, China. john131212@126.com.'}]",Trials,['10.1186/s13063-020-04399-8'] 1636,32517847,Evaluation of daily patch application duration for epicutaneous immunotherapy for peanut allergy.,"Background: Epicutaneous immunotherapy is a potential novel immunotherapy that utilizes unique cutaneous immunologic properties. In a phase III, randomized, double-blind, placebo controlled clinical trial, an epicutaneous patch (DBV712) with 250 µg of peanut protein applied once daily for 12-months was statistically superior to placebo in desensitizing children with peanut allergy (ages 4-11 years) (N = 356). Objective: To assess the relationship between the hours of daily application time and the efficacy of DBV712 250 µg. Methods: DBV712 250 µg was applied to 30 nonallergic volunteers for various durations from 2 to 24 hours and then assayed for residual peanut protein. Patch application data from the phase III clinical trial were analyzed post hoc according to prespecified responder rates and changes in the eliciting dose (ED), as measured by the geometric mean (GM) ED ratio (12 months/baseline). Results: Following application, there was a marked decrease in peanut protein on the patches from 2 to 12 hours. After 12 hours, the median peanut protein recovered was below quantification limits. The median daily patch application duration in subjects from the phase III clinical trial was 21.1 hours (DBV712 250 µg) and 22.4 hours (placebo). Ninety-five percent of the treated population achieved >10 hours per day mean application. Response rates and GM ED ratios were similar among subjects across a range of application durations; e.g. , in those with a mean duration of >10 hours, the response rate was 36.6% and the GM ED ratio was 3.8, comparable with 42.6% and 4.0, respectively, in those with a mean duration of >20 hours. In DBV712 250 µg subjects with >16 hours mean application duration (84.5% of the treated population), the response rate was 38.8% versus 13.4% for placebo (difference, 24.4% [95% confidence interval, 15.5-34.0%]; p < 0.001). Conclusion: An evaluation of residual peanut protein on patches following application and post hoc analysis of phase III data strongly suggest that allergen delivery is attained with 12-16 hours of daily patch application time, sufficient to drive clinically meaningful desensitization to peanut after 12 months.",2020,"In DBV712 250 micrograms subjects with >16 hours mean application duration (84.5% of the treated population), the response rate was 38.8% versus 13.4% for placebo (difference, 24.4% [95% confidence interval, 15.5-34.0%]; p < 0.001). ","['desensitizing children with peanut allergy (ages 4-11 years', '30 nonallergic volunteers for various durations from 2 to 24 hours and thenassayed for residual peanut protein', 'peanut allergy']","['epicutaneous patch (DBV712) with 250 micrograms of peanut protein', 'DBV712 250 micrograms', 'placebo']","['geometric mean (GM) ED ratio (12months/baseline', 'response rate', 'median peanut protein', 'median daily patch application duration', 'peanut protein', 'Response rates and GM ED ratios']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0559470', 'cui_str': 'Allergy to peanut'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0030736', 'cui_str': 'Arachis hypogaea'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}]","[{'cui': 'C0332461', 'cui_str': 'Plaque'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0439211', 'cui_str': 'mcg'}, {'cui': 'C0030736', 'cui_str': 'Arachis hypogaea'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449265', 'cui_str': 'Elicited by'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0030736', 'cui_str': 'Arachis hypogaea'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332461', 'cui_str': 'Plaque'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0449238', 'cui_str': 'Duration'}]",356.0,0.140751,"In DBV712 250 micrograms subjects with >16 hours mean application duration (84.5% of the treated population), the response rate was 38.8% versus 13.4% for placebo (difference, 24.4% [95% confidence interval, 15.5-34.0%]; p < 0.001). ","[{'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Fleischer', 'Affiliation': ""From the Children's Hospital Colorado, University of Colorado School of Medicine, Aurora, Colorado.""}, {'ForeName': 'Jonathan M', 'Initials': 'JM', 'LastName': 'Spergel', 'Affiliation': ""Children's Hospital of Philadelphia, Philadelphia, Pennsylvania.""}, {'ForeName': 'Edwin H', 'Initials': 'EH', 'LastName': 'Kim', 'Affiliation': 'University of North Carolina School of Medicine, Chapel Hill, North Carolina.'}, {'ForeName': 'Dianne E', 'Initials': 'DE', 'LastName': 'Campbell', 'Affiliation': 'DBV Technologies, Montrouge, France.'}, {'ForeName': 'Todd D', 'Initials': 'TD', 'LastName': 'Green', 'Affiliation': 'DBV Technologies, Montrouge, France.'}, {'ForeName': 'Katharine J', 'Initials': 'KJ', 'LastName': 'Bee', 'Affiliation': 'DBV Technologies, Montrouge, France.'}, {'ForeName': 'Romain', 'Initials': 'R', 'LastName': 'Lambert', 'Affiliation': 'DBV Technologies, Montrouge, France.'}, {'ForeName': 'Terrance', 'Initials': 'T', 'LastName': 'Ocheltree', 'Affiliation': 'Certara, Princeton, New Jersey; and.'}, {'ForeName': 'Hugh A', 'Initials': 'HA', 'LastName': 'Sampson', 'Affiliation': 'DBV Technologies, Montrouge, France.'}]",Allergy and asthma proceedings,['10.2500/aap.2020.41.200045'] 1637,32518012,A multimodality triage algorithm to improve cytoreductive outcomes in patients undergoing primary debulking surgery for advanced ovarian cancer: A Memorial Sloan Kettering Cancer Center team ovary initiative.,"OBJECTIVE To describe outcomes using a multimodal algorithm to triage patients with advanced epithelial ovarian cancer (EOC) to primary debulking surgery (PDS) versus neoadjuvant chemotherapy (NACT). METHODS All patients with EOC treated at our institution from 04/2015-08/2018 were identified. We included patients without contraindication to PDS who underwent prospective calculation of a Resectability (R)-score. A low risk score for suboptimal cytoreduction was defined as ≤6, and a high risk score ≥7. Patients were triaged to laparotomy/PDS, laparoscopic evaluation of resectability (LSC), or NACT depending on R-score. RESULTS Among 299 participants, 226 (76%) had a low risk score and 73 (24%) a high risk score. For patients with a low risk score, management included laparotomy/PDS, 181 (80%); LSC, 43 (19%) (with subsequent triage: PDS, 31; NACT, 12); and NACT, 2 (1%). For patients with a high risk score, management included laparotomy/PDS, 9 (12%); LSC, 51 (70%) (with subsequent triage: PDS, 28; NACT, 23); and NACT, 13 (18%). Overall, 83% underwent PDS, with a 75% CGR rate and 94% optimal cytoreduction rate. Use of the algorithm resulted in a 31% LSC rate and a 6% rate of suboptimal PDS. CONCLUSIONS The multimodal algorithm led to excellent surgical results; 94% of patients achieved an optimal resection, with a very low rate of suboptimal cytoreduction.",2020,"The multimodal algorithm led to excellent surgical results; 94% of patients achieved an optimal resection, with a very low rate of suboptimal cytoreduction.","['triage patients with advanced epithelial ovarian cancer (EOC', 'patients undergoing primary debulking surgery for advanced ovarian cancer', '299 participants, 226 (76%) had a low risk score and 73 (24%) a high risk score', 'All patients with EOC treated at our institution from 04/2015-08/2018 were identified', 'patients without contraindication to PDS who underwent prospective calculation of a Resectability (R)-score']",['primary debulking surgery (PDS) versus neoadjuvant chemotherapy (NACT'],"['cytoreductive outcomes', 'triaged to laparotomy/PDS, laparoscopic evaluation of resectability (LSC), or NACT depending on R-score']","[{'cui': 'C0040861', 'cui_str': 'Triage'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C4721610', 'cui_str': 'Epithelial Ovarian Carcinoma'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0919267', 'cui_str': 'Neoplasm of ovary'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0522473', 'cui_str': 'Contraindication to'}, {'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C1441506', 'cui_str': 'Calculation technique'}]","[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0023038', 'cui_str': 'Laparotomy'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",299.0,0.0508146,"The multimodal algorithm led to excellent surgical results; 94% of patients achieved an optimal resection, with a very low rate of suboptimal cytoreduction.","[{'ForeName': 'Alli M', 'Initials': 'AM', 'LastName': 'Straubhar', 'Affiliation': 'Gynecology Service, Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Olga T', 'Initials': 'OT', 'LastName': 'Filippova', 'Affiliation': 'Gynecology Service, Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Renee A', 'Initials': 'RA', 'LastName': 'Cowan', 'Affiliation': 'Gynecology Service, Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Yulia', 'Initials': 'Y', 'LastName': 'Lakhman', 'Affiliation': 'Department of Radiology, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Debra M', 'Initials': 'DM', 'LastName': 'Sarasohn', 'Affiliation': 'Department of Radiology, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Ines', 'Initials': 'I', 'LastName': 'Nikolovski', 'Affiliation': 'Department of Radiology, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Jean M', 'Initials': 'JM', 'LastName': 'Torrisi', 'Affiliation': 'Department of Radiology, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Weining', 'Initials': 'W', 'LastName': 'Ma', 'Affiliation': 'Department of Radiology, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Nadeem R', 'Initials': 'NR', 'LastName': 'Abu-Rustum', 'Affiliation': 'Gynecology Service, Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, NY, USA; Department of Obstetrics & Gynecology, Weill Cornell Medical College, New York, NY, USA.'}, {'ForeName': 'Ginger J', 'Initials': 'GJ', 'LastName': 'Gardner', 'Affiliation': 'Gynecology Service, Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, NY, USA; Department of Obstetrics & Gynecology, Weill Cornell Medical College, New York, NY, USA.'}, {'ForeName': 'Yukio', 'Initials': 'Y', 'LastName': 'Sonoda', 'Affiliation': 'Gynecology Service, Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, NY, USA; Department of Obstetrics & Gynecology, Weill Cornell Medical College, New York, NY, USA.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Zivanovic', 'Affiliation': 'Gynecology Service, Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, NY, USA; Department of Obstetrics & Gynecology, Weill Cornell Medical College, New York, NY, USA.'}, {'ForeName': 'Dennis S', 'Initials': 'DS', 'LastName': 'Chi', 'Affiliation': 'Gynecology Service, Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, NY, USA; Department of Obstetrics & Gynecology, Weill Cornell Medical College, New York, NY, USA.'}, {'ForeName': 'Kara', 'Initials': 'K', 'LastName': 'Long Roche', 'Affiliation': 'Gynecology Service, Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, NY, USA; Department of Obstetrics & Gynecology, Weill Cornell Medical College, New York, NY, USA. Electronic address: longrock@mskcc.org.'}]",Gynecologic oncology,['10.1016/j.ygyno.2020.05.041'] 1638,32520870,Sedentary Time and Physical Activity in Older Women Undergoing Exercise Training.,"Older adults have low rates meeting the physical activity (PA) guidelines and high sedentary time. Low PA and excessive sedentary time have been linked to adverse health outcomes. Less is known about whether exercise training influences sedentary time and PA in various intensities. PURPOSE To examine the effects of a 16-week aerobic exercise training on time spent being sedentary and on PA time of light (LPA) and moderate-to-vigorous (MVPA) intensities, and step numbers in older women. METHODS Inactive women (n = 61; age = 65.5 ± 4.3 years) participated in moderate-intensity walking of either a low or a moderate dose (33.6 and 58.8 kJ·kg body weight per week, respectively). They wore a SenseWear Mini Armband at baseline and at end-intervention to determine sedentary, LPA, and MVPA time, and step numbers. RESULTS Time being sedentary, or spent on LPA and MVPA, did not change differently by exercise groups with different doses (all p values for group by time interaction > 0.580). Overall, time being sedentary reduced from baseline to end-intervention by approximately 39 minutes (p < 0.001) and LPA increased by 19 minutes per day (p = 0.003). MVPA time increased (p < 0.001), which was primarily accounted for by the supervised exercise. Interestingly, daily steps increased more in the moderate-dose than the low-dose group (p = 0.023 for group by time interaction; 33.6% and 19.8% median increase in moderate- and low-dose groups, respectively). Also, there were individual differences in these changes. CONCLUSION Results indicated that on average, older women did not reduce time of LPA or MVPA outside of the exercise program, or increase sedentary time as a result of participating in the exercise program.",2020,"Overall, time being sedentary reduced from baseline to end-intervention by approximately 39 minutes (p < 0.001) and LPA increased by 19 minutes per day (p = 0.003).","['older women', 'Older Women Undergoing Exercise Training', 'Older adults', 'Inactive women (n = 61; age = 65.5 ± 4.3 years) participated in moderate-intensity walking of either a low or a moderate dose (33.6 and 58.8 kJ·kg body weight per week, respectively']","['exercise training', 'aerobic exercise training']","['sedentary time', 'time spent being sedentary and on PA time of light (LPA) and moderate-to-vigorous (MVPA) intensities, and step numbers', 'Sedentary Time and Physical Activity', 'MVPA time', 'LPA']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517759', 'cui_str': '4.3'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C1096202', 'cui_str': 'Lipoprotein (a) measurement'}]",61.0,0.0344794,"Overall, time being sedentary reduced from baseline to end-intervention by approximately 39 minutes (p < 0.001) and LPA increased by 19 minutes per day (p = 0.003).","[{'ForeName': 'Xuewen', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Exercise Science, University of South Carolina, Columbia, SC.'}, {'ForeName': 'Charity B', 'Initials': 'CB', 'LastName': 'Breneman', 'Affiliation': ''}, {'ForeName': 'Joshua R', 'Initials': 'JR', 'LastName': 'Sparks', 'Affiliation': ''}, {'ForeName': 'Steven N', 'Initials': 'SN', 'LastName': 'Blair', 'Affiliation': ''}]",Medicine and science in sports and exercise,['10.1249/MSS.0000000000002407'] 1639,32521324,"Evaluation of the impact of a nurse-led program of systematic screening of comorbidities in patients with axial spondyloarthritis: The results of the COMEDSPA prospective, controlled, one year randomized trial.","OBJECTIVE To evaluate the impact of a nurse-led program of systematic screening for the management (detection/prevention) of comorbidities. METHODS Prospective, randomized, controlled, open, 12-month trial (NCT02374749). PARTICIPANTS consecutive patients with axial Spondyloarthritis (axSpA) (according to the rheumatologist) THE PROGRAM: A nurse collected data on comorbidities during a specific outpatient visit. In the event of non-agreement with recommendations, the patient was informed and a specific recommendation was given to the patient (orally and in a with a detailed written report). Patients were seen after one year in a nurse-led visit. TREATMENT ALLOCATION: random allocation (i.e. either this program or an educational program not presented here and considered here as the control group). MAIN OUTCOME change after one year of a weighted comorbidity management score (0 to 100 where 0= optimal management). RESULTS 502 patients were included (252 and 250 in the active and control groups, respectively): age: 47±12 years, male gender: 63%, disease duration: 14±11y. After one year, no differences were observed in a weighted comorbidity management score. However, the number of patients in agreement with recommendations was significantly higher in the active group for vaccinations (flu vaccination: 28.6% vs. 9.9%, p<0.01; pneumococcal vaccination:40.0% vs. 21.1%,p=0.04), for cancer screening (skin cancer screening: 36.3% vs. 17.2%, p=0.04) and for osteoporosis (bone densitometry performed: 22.6% vs. 8.7%, p<0.01; Vitamin D supplementation initiation: 51.9% vs. 9.4%, p<0.01). CONCLUSIONS AND RELEVANCE This study suggests the short-term benefit of a single-visit nurse-led program for systematic screening of comorbidities for its management in agreement with recommendations, even in this young population of patients with axSpA.",2020,"However, the number of patients in agreement with recommendations was significantly higher in the active group for vaccinations (flu vaccination: 28.6% vs. 9.9%, p<0.01; pneumococcal vaccination:40.0% vs. 21.1%,p=0.04), for cancer screening (skin cancer screening: 36.3% vs. 17.2%, p=0.04) and for osteoporosis (bone densitometry performed: 22.6% vs. 8.7%, p<0.01; Vitamin D supplementation initiation: 51.9% vs. 9.4%, p<0.01). ","['consecutive patients with axial Spondyloarthritis (axSpA) (according to the rheumatologist) THE PROGRAM', 'patients with axial spondyloarthritis', '502 patients were included (252 and 250 in the active and control groups, respectively): age: 47±12 years, male gender: 63%, disease duration: 14±11y', 'young population of patients with axSpA']","['nurse-led program of systematic screening', 'nurse-led program', 'single-visit nurse-led program']",['weighted comorbidity management score'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3203547', 'cui_str': 'Axial spondyloarthritis'}, {'cui': 'C0334889', 'cui_str': 'Rheumatologist'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0042799', 'cui_str': 'Home Nurses'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",502.0,0.0692749,"However, the number of patients in agreement with recommendations was significantly higher in the active group for vaccinations (flu vaccination: 28.6% vs. 9.9%, p<0.01; pneumococcal vaccination:40.0% vs. 21.1%,p=0.04), for cancer screening (skin cancer screening: 36.3% vs. 17.2%, p=0.04) and for osteoporosis (bone densitometry performed: 22.6% vs. 8.7%, p<0.01; Vitamin D supplementation initiation: 51.9% vs. 9.4%, p<0.01). ","[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Molto', 'Affiliation': 'Rheumatology Department, Cochin Hospital, Assistance Publique Hôpitaux de Paris, Paris, France; Université de Paris, INSERM U-1153, CRESS, Paris, France. Electronic address: anna.molto@aphp.fr.'}, {'ForeName': 'Laure', 'Initials': 'L', 'LastName': 'Gossec', 'Affiliation': 'Sorbonne Université, IPLESP, INSERM, Paris France; Pitié Salpêtrière hospital, APHP, Rheumatology department, Paris, France.'}, {'ForeName': 'Serge', 'Initials': 'S', 'LastName': 'Poiraudeau', 'Affiliation': 'Rehabilitation and Physical Medicine Department, Cochin Hospital, Assistance Publique Hôpitaux de Paris, Paris, France.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Claudepierre', 'Affiliation': 'Rheumatology Department, Henri Mondor Hospital, Assistance Publique Hôpitaux de Paris, and Université Paris Est Créteil, EA, 7379 - EpidermE, F-94010, Créteil, France.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Soubrier', 'Affiliation': 'Rheumatology Department, CHU Clermont-Ferrand, Clermont-Ferrand, France.'}, {'ForeName': 'Françoise', 'Initials': 'F', 'LastName': 'Fayet', 'Affiliation': 'Rheumatology Department, CHU Clermont-Ferrand, Clermont-Ferrand, France.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Wendling', 'Affiliation': 'Rheumatology Department, CHRU de BESANCON, University Teaching Hospital, and Université Bourgogne Franche-Comté, EA4266 (EPILAB), Besançon, France.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Gaudin', 'Affiliation': 'Rheumatology Department, CHU Grenoble, France.'}, {'ForeName': 'Emmanuelle', 'Initials': 'E', 'LastName': 'Dernis', 'Affiliation': 'Rheumatology Department, CH Le Mans, France.'}, {'ForeName': 'Sandrine', 'Initials': 'S', 'LastName': 'Guis', 'Affiliation': 'Rheumatology Department, CHU Marseille, France.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Pouplin', 'Affiliation': 'Rheumatology Department, CHU Rouen, France.'}, {'ForeName': 'Adeline', 'Initials': 'A', 'LastName': 'Ruyssen', 'Affiliation': 'Centre de Rhumatologie, Hôpital Purpan, Toulouse, et Faculté de Médecine, Université Toulouse III, Paul Sabatier University, Toulouse, France.'}, {'ForeName': 'Gerard', 'Initials': 'G', 'LastName': 'Chales', 'Affiliation': 'Medecine Faculty, Department of Rheumatology, South Hospital, Rennes 1 University, Rennes, France.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Mariette', 'Affiliation': 'Rheumatology Department, APHP, Bicêtre Hospital, Le Kremlin-Bicetre, France.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Beauvais', 'Affiliation': 'Rheumatology Department, Saint Antoine Hospital, APHP, Paris, France.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Combe', 'Affiliation': 'Rheumatology department, CHU Montpellier, Montpellier University, Montpellier, France.'}, {'ForeName': 'René-Marc', 'Initials': 'RM', 'LastName': 'Flipo', 'Affiliation': 'Rheumatology Department, CHU Roger Salengro Hospital, University of Lille, Lille, France.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Richette', 'Affiliation': 'Université Paris Diderot, UFR médicale, Paris, France; APHP Hôpital Lariboisiére, Fédération de Rhumatologie, Paris, France.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Chary-Valckenaere', 'Affiliation': 'Department of Rheumatology, Nancy Hospital, Nancy, France.'}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Saraux', 'Affiliation': 'Rheumatology Unit, UMR1227 (Lymphocytes B et Autoimmunité), Université de Brest, Inserm, CHU Brest, LabEx IGO, Brest, France.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Sibilia', 'Affiliation': 'Department of Rheumatology, Hautepierre CHU, Fédération de médecine translationnelle, UMR INSERM 1109, Strasbourg, France.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Schaeverbeke', 'Affiliation': 'Rheumatology Department, Pellegrin Hospital, Bordeaux, France.'}, {'ForeName': 'Maxime', 'Initials': 'M', 'LastName': 'Dougados', 'Affiliation': 'Rheumatology Department, Cochin Hospital, Assistance Publique Hôpitaux de Paris, Paris, France; Université de Paris, INSERM U-1153, CRESS, Paris, France.'}]",Seminars in arthritis and rheumatism,['10.1016/j.semarthrit.2020.05.012'] 1640,32521358,Protocol for a partially nested randomised controlled trial to evaluate the effectiveness of the scleroderma patient-centered intervention network COVID-19 home-isolation activities together (SPIN-CHAT) program to reduce anxiety among at-risk scleroderma patients.,"OBJECTIVE Contagious disease outbreaks and related restrictions can lead to negative psychological outcomes, particularly in vulnerable populations at risk due to pre-existing medical conditions. No randomised controlled trials (RCTs) have tested interventions to reduce mental health consequences of contagious disease outbreaks. The primary objective of the Scleroderma Patient-centered Intervention Network COVID-19 Home-isolation Activities Together (SPIN-CHAT) Trial is to evaluate the effect of a videoconference-based program on symptoms of anxiety. Secondary objectives include evaluating effects on symptoms of depression, stress, loneliness, boredom, physical activity, and social interaction. METHODS The SPIN-CHAT Trial is a pragmatic RCT that will be conducted using the SPIN-COVID-19 Cohort, a sub-cohort of the SPIN Cohort. Eligible participants will be SPIN-COVID-19 Cohort participants without a positive COVID-19 test, with at least mild anxiety (PROMIS Anxiety 4a v1.0 T-score ≥ 55), not working from home, and not receiving current counselling or psychotherapy. We will randomly assign 162 participants to intervention groups of 7 to 10 participants each or waitlist control. We will use a partially nested RCT design to reflect dependence between individuals in training groups but not in the waitlist control. The SPIN-CHAT Program includes activity engagement, education on strategies to support mental health, and mutual participant support. Intervention participants will receive the 4-week (3 sessions per week) SPIN-CHAT Program via videoconference. The primary outcome is PROMIS Anxiety 4a score immediately post-intervention. ETHICS AND DISSEMINATION The SPIN-CHAT Trial will test whether a brief videoconference-based intervention will improve mental health outcomes among at-risk individuals during contagious disease outbreak.",2020,"Secondary objectives include evaluating effects on symptoms of depression, stress, loneliness, boredom, physical activity, and social interaction. ","['Eligible participants will be SPIN-COVID-19 Cohort participants without a positive COVID-19 test, with at least mild anxiety (PROMIS Anxiety 4a v1.0 T-score\u202f≥\u202f55), not working from home, and not receiving current counselling or psychotherapy', '162 participants to intervention groups of 7 to 10 participants each or', 'at-risk scleroderma patients']","['Scleroderma Patient-centered Intervention Network COVID-19 Home-isolation Activities', 'videoconference-based intervention', 'scleroderma patient-centered intervention network COVID-19 home-isolation activities together (SPIN-CHAT) program', 'Together (SPIN-CHAT', 'waitlist control', 'videoconference-based program']","['symptoms of depression, stress, loneliness, boredom, physical activity, and social interaction', 'PROMIS Anxiety 4a score immediately post-intervention', 'mental health outcomes', 'symptoms of anxiety']","[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0231401', 'cui_str': 'Mild anxiety'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C3854607', 'cui_str': 'T score'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0033968', 'cui_str': 'Psychotherapy'}, {'cui': 'C5191360', 'cui_str': '162'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0011644', 'cui_str': 'Scleroderma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0011644', 'cui_str': 'Scleroderma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0037421', 'cui_str': 'Social isolation'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C1450049', 'cui_str': 'Videoconference'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0023974', 'cui_str': 'Feeling lonely'}, {'cui': 'C0006019', 'cui_str': 'Boredom'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0037420', 'cui_str': 'Interaction with others'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205548', 'cui_str': 'Stat'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",162.0,0.100017,"Secondary objectives include evaluating effects on symptoms of depression, stress, loneliness, boredom, physical activity, and social interaction. ","[{'ForeName': 'Brett D', 'Initials': 'BD', 'LastName': 'Thombs', 'Affiliation': 'Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada; Department of Psychiatry, McGill University, Montreal, Quebec, Canada; Department of Epidemiology, Biostatistics, and Occupational Health, McGill University, Montreal, Quebec, Canada; Department of Medicine, McGill University, Montreal, Quebec, Canada; Department of Psychology, McGill University, Montreal, Quebec, Canada; Department of Educational and Counselling Psychology, McGill University, Montreal, Quebec, Canada; Biomedical Ethics Unit, McGill University, Montreal, Quebec, Canada. Electronic address: brett.thombs@mcgill.ca.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Kwakkenbos', 'Affiliation': 'Department of Clinical Psychology, Behavioural Science Institute, Radboud University, Nijmegen, the Netherlands.'}, {'ForeName': 'Marie-Eve', 'Initials': 'ME', 'LastName': 'Carrier', 'Affiliation': 'Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada.'}, {'ForeName': 'Angelica', 'Initials': 'A', 'LastName': 'Bourgeault', 'Affiliation': 'Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada.'}, {'ForeName': 'Lydia', 'Initials': 'L', 'LastName': 'Tao', 'Affiliation': 'Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada.'}, {'ForeName': 'Sami', 'Initials': 'S', 'LastName': 'Harb', 'Affiliation': 'Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada; Department of Psychiatry, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Gagarine', 'Affiliation': 'Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada; Department of Epidemiology, Biostatistics, and Occupational Health, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Rice', 'Affiliation': 'Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada; Department of Psychology, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Bustamante', 'Affiliation': 'Department of Applied Human Sciences, Concordia University, Montreal, Quebec, Canada.'}, {'ForeName': 'Kelsey', 'Initials': 'K', 'LastName': 'Ellis', 'Affiliation': 'Faculty of Kinesiology, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Delaney', 'Initials': 'D', 'LastName': 'Duchek', 'Affiliation': 'Faculty of Kinesiology, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Yin', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada; Department of Psychiatry, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Parash Mani', 'Initials': 'PM', 'LastName': 'Bhandari', 'Affiliation': 'Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada; Department of Epidemiology, Biostatistics, and Occupational Health, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Dipika', 'Initials': 'D', 'LastName': 'Neupane', 'Affiliation': 'Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada; Department of Epidemiology, Biostatistics, and Occupational Health, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Carboni-Jiménez', 'Affiliation': 'Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada; Department of Psychiatry, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Richard S', 'Initials': 'RS', 'LastName': 'Henry', 'Affiliation': 'Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada; Department of Psychiatry, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Ankur', 'Initials': 'A', 'LastName': 'Krishnan', 'Affiliation': 'Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada.'}, {'ForeName': 'Brooke', 'Initials': 'B', 'LastName': 'Levis', 'Affiliation': 'Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada; Department of Epidemiology, Biostatistics, and Occupational Health, McGill University, Montreal, Quebec, Canada; Centre for Prognosis Research, School of Primary, Community and Social Care, Keele University, Staffordshire, UK.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'He', 'Affiliation': 'Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada.'}, {'ForeName': 'Kimberly A', 'Initials': 'KA', 'LastName': 'Turner', 'Affiliation': 'Lady Davis Institute for Medical Research, Jewish General Hospital, Montreal, Quebec, Canada.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Benedetti', 'Affiliation': 'Department of Epidemiology, Biostatistics, and Occupational Health, McGill University, Montreal, Quebec, Canada; Department of Medicine, McGill University, Montreal, Quebec, Canada; Respiratory Epidemiology and Clinical Research Unit, McGill University Health Centre, Montreal, Quebec, Canada.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Culos-Reed', 'Affiliation': 'Department of Applied Human Sciences, Concordia University, Montreal, Quebec, Canada; Department of Oncology, Cumming School of Medicine, Calgary, Canada; Department of Psychosocial Resources, Tom Baker Cancer Centre, Alberta Health Services, Calgary, Alberta, Canada.'}, {'ForeName': 'Ghassan', 'Initials': 'G', 'LastName': 'El-Baalbaki', 'Affiliation': 'Department of Psychology, Université du Québec à Montréal, Montreal, Quebec, Canada.'}, {'ForeName': 'Shannon', 'Initials': 'S', 'LastName': 'Hebblethwaite', 'Affiliation': 'Department of Applied Human Sciences, Concordia University, Montreal, Quebec, Canada.'}, {'ForeName': 'Susan J', 'Initials': 'SJ', 'LastName': 'Bartlett', 'Affiliation': 'Department of Medicine, McGill University, Montreal, Quebec, Canada; Research Institute, McGill University Health Centre, Montreal, Quebec, Canada.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Dyas', 'Affiliation': 'Scleroderma Foundation Michigan Chapter, Southfield, MI, USA.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Patten', 'Affiliation': ""Department of Community Health Sciences, University of Calgary, Calgary, Alberta, Canada; Hotchkiss Brain Institute and O'Brien Institute for Public Health, University of Calgary, Calgary, Alberta, Canada.""}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Varga', 'Affiliation': 'Northwestern Scleroderma Program, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of psychosomatic research,['10.1016/j.jpsychores.2020.110132'] 1641,32521394,Effects of perioperative magnesium sulfate infusion on intraoperative blood loss and postoperative analgesia in patients undergoing posterior lumbar spinal fusion surgery: A randomized controlled trial.,"OBJECTIVE Many studies have suggested the anti-nociceptive role for magnesium either as an adjunct for postoperative pain. Although several studies have been carried out to evaluate the anti-nociceptive effect of magnesium, there is still considerable uncertainty. PATIENTS AND METHODS Eighty patients who underwent posterior spinal fusion were randomly divided into two groups (magnesium and saline). Changes in cell count, magnesium concentration and coagulation status were assessed one hour after operation at both group and compared to baseline. At recovery room, their pain score was assessed according to 10 points visual analogue scale (VAS). Morphine consumption was evaluated at regular times after the surgery by patient controlled analgesia (PCA) device. RESULTS VAS scores were significantly lower in the magnesium group. Cumulative PCA morphine consumption after the surgery was significantly lower in the magnesium group. Pre and postoperative values for haemoglobin, platelet count, Prothrombin Time (PT), fibrinogen were not significantly different. There was a significant increase in activated Partial Thromboplastin Time (aPTT), International Normalized Ratio (INR), and bleeding time (BT), one hour after the operation in the magnesium group but intraoperative blood loss was similar in both groups. CONCLUSIONS Perioperative magnesium sulfate infusion improves the postoperative analgesia, decreases the amount of morphine consumption after the operation and does not change the intraoperative bleeding in patients undergoing posterior spinal fusion surgery.",2020,"Pre and postoperative values for haemoglobin, platelet count, Prothrombin Time (PT), fibrinogen were not significantly different.","['patients undergoing posterior spinal fusion surgery', 'Eighty patients who underwent posterior spinal fusion', 'patients undergoing posterior lumbar spinal fusion surgery']","['Perioperative magnesium sulfate infusion', 'magnesium and saline', 'magnesium', 'perioperative magnesium sulfate infusion']","['postoperative analgesia', 'intraoperative bleeding', 'Pre and postoperative values for haemoglobin, platelet count, Prothrombin Time (PT), fibrinogen', 'morphine consumption', 'cell count, magnesium concentration and coagulation status', 'Morphine consumption', 'intraoperative blood loss', 'pain score', 'activated Partial Thromboplastin Time (aPTT), International Normalized Ratio (INR), and bleeding time (BT', 'Cumulative PCA morphine consumption', 'intraoperative blood loss and postoperative analgesia', 'VAS scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0919636', 'cui_str': 'Spinal fusion surgery'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0037935', 'cui_str': 'Spinal arthrodesis'}, {'cui': 'C0186045', 'cui_str': 'Lumbar spinal fusion'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0024480', 'cui_str': 'Magnesium Sulfate'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0024467', 'cui_str': 'Magnesium'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}]","[{'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0032181', 'cui_str': 'Platelet count'}, {'cui': 'C0033707', 'cui_str': 'Prothrombin time'}, {'cui': 'C0016006', 'cui_str': 'Fibrinogen'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0024467', 'cui_str': 'Magnesium'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0005778', 'cui_str': 'Coagulation, Blood'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0030605', 'cui_str': 'Partial thromboplastin time, activated'}, {'cui': 'C0525032', 'cui_str': 'International normalized ratio'}, {'cui': 'C0005729', 'cui_str': 'Bleeding time'}, {'cui': 'C0078944', 'cui_str': 'Patient controlled analgesia'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}]",80.0,0.140799,"Pre and postoperative values for haemoglobin, platelet count, Prothrombin Time (PT), fibrinogen were not significantly different.","[{'ForeName': 'Masih Ebrahimy', 'Initials': 'ME', 'LastName': 'Dehkordy', 'Affiliation': 'Department of Anesthesiology, Shohada Tajrish Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Roozbeh', 'Initials': 'R', 'LastName': 'Tavanaei', 'Affiliation': 'Shohada Tajrish Neurosurgical Center of Excellence, Functional Neurosurgery Research Center, Shohada Tajrish Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Elahe', 'Initials': 'E', 'LastName': 'Younesi', 'Affiliation': 'Department of Anesthesiology, Shohada Tajrish Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Shayesteh', 'Initials': 'S', 'LastName': 'Khorasanizade', 'Affiliation': 'Department of Anesthesiology, Shohada Tajrish Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hamidreza Azizi', 'Initials': 'HA', 'LastName': 'Farsani', 'Affiliation': 'Department of Anesthesiology, Shohada Tajrish Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Saeed', 'Initials': 'S', 'LastName': 'Oraee-Yazdani', 'Affiliation': 'Shohada Tajrish Neurosurgical Center of Excellence, Functional Neurosurgery Research Center, Shohada Tajrish Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran. Electronic address: Saeed_o_yazdani@sbmu.ac.ir.'}]",Clinical neurology and neurosurgery,['10.1016/j.clineuro.2020.105983'] 1642,32521448,Design cues for tobacco communication: Heuristic interpretations and usability of online health information about harmful chemicals.,"OBJECTIVE Many people have a poor understanding of the numerous chemicals in tobacco products that cause severe health harms. The US government must display a list of these harmful chemicals for the public. Online disclosures are one promising solution, but evidence is needed for effective design strategies to encourage interpretation and use of information as intended. METHOD To examine the impact of website designs for the activation of heuristics and usability perceptions, a national probability sample of US adolescents and adults (n = 1441) was randomized in a 3 (chemical format) × 2 (webpage layout) between-subjects online experiment. Chemicals were displayed as names only, with a visual risk indicator, or with numerical ranges. Layouts displayed health harms at the top of the webpage separate from chemicals or the chemicals grouped by associated health harms. Participants viewed a webpage and reported activated heuristics, usability (perceived ease of use and usefulness), and intentions to use the website. RESULTS Displaying risk indicators increased website usability by encouraging users to rely on colors to interpret the risk of the chemicals (all p < .01). Website designs that grouped chemicals with harms allowed users to link the chemicals to harms they cause and increased perceived usability and intentions to use the website (all p < .001). CONCLUSION Assessing heuristics gives insights for how US adolescents and adults interpret chemical information and the impact of design strategies on usability. Public disclosures of chemicals in tobacco products could be optimized with color-coded risk indicators and layouts placing chemicals near the harms they cause.",2020,"Website designs that grouped chemicals with harms allowed users to link the chemicals to harms they cause and increased perceived usability and intentions to use the website (all p < .001). ",['US adolescents and adults (n = 1441'],[],['website usability'],"[{'cui': 'C0002838', 'cui_str': 'Andorra'}]",[],[],1441.0,0.0625486,"Website designs that grouped chemicals with harms allowed users to link the chemicals to harms they cause and increased perceived usability and intentions to use the website (all p < .001). ","[{'ForeName': 'Allison J', 'Initials': 'AJ', 'LastName': 'Lazard', 'Affiliation': 'School of Media and Journalism, University of North Carolina at Chapel Hill, NC 27599-3365, United States; Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, NC 27599-3365, United States. Electronic address: lazard@unc.edu.'}]",International journal of medical informatics,['10.1016/j.ijmedinf.2020.104177'] 1643,32521472,Improvement of dynamic postural stability by an exercise program.,"BACKGROUND Central processing of multi-sensory feedback and motor commands responsible for force production are critical for postural control. An exercise program was developed to realign spinal curvature, but its effect on postural control is unknown. RESEARCH QUESTION To what extent would the exercise program influence on center of pressure (CoP) sway on stable and unstable surfaces? METHODS Subjects (n = 30) were randomly assigned into one of three groups: exercise on a cylinder-shaped tube (98-cm length, 15-cm diameter, n = 10), exercise on a flat surface (n = 10), and a control group that laid supine on a flat surface (n = 10). Standing posture of each subject was quantified using anterior-, posterior-, and lateral-view photography. Each subject's CoP sway was measured while standing on a static and dynamic platform with eyes open and eyes closed. Subjects were instructed to stand still when the platform was held stationary (e.g., no tilt) during the static condition. During the dynamic condition the platform was allowed to tilt in response to changes of CoP and subjects were instructed to maintain the platform in a horizontal position. RESULTS Only when subjects performed the exercise program on the tube, the angles of neck flexion and pelvis tilt decreased, and CoP sway in the sagittal, but not frontal plane, decreased during the dynamic platform conditions with both eyes open and eyes closed (p < 0.05). SIGNIFICANCE It is speculated that performing the exercise program on the tube might enhance a) central processing of somatosensory and vestibular inputs, b) motor commands responsible for force production in postural control, and c) biomechanical advantage by the realigned posture. The exercise program can be used by a variety of populations as home-exercise to realign the neck and pelvic posture and improve dynamic postural stability.",2020,"Only when subjects performed the exercise program on the tube, the angles of neck flexion and pelvis tilt decreased, and CoP sway in the sagittal, but not frontal plane, decreased during the dynamic platform conditions with both eyes open and eyes closed (p < 0.05). ",['Subjects (n\u202f=\u202f30'],"['exercise on a cylinder-shaped tube (98-cm length, 15-cm diameter, n\u202f=\u202f10), exercise on a flat surface (n\u202f=\u202f10), and a control group that laid supine']","['dynamic postural stability', 'neck flexion and pelvis tilt decreased, and CoP sway']",[],"[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0181797', 'cui_str': 'Medical gas cylinder'}, {'cui': 'C0332479', 'cui_str': 'Shape finding'}, {'cui': 'C0175730', 'cui_str': 'Tube'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0205324', 'cui_str': 'Flat'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038846', 'cui_str': 'Supine body position'}]","[{'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0205278', 'cui_str': 'Postural'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0445088', 'cui_str': 'Neck flexion'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}]",30.0,0.0135493,"Only when subjects performed the exercise program on the tube, the angles of neck flexion and pelvis tilt decreased, and CoP sway in the sagittal, but not frontal plane, decreased during the dynamic platform conditions with both eyes open and eyes closed (p < 0.05). ","[{'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Shibata', 'Affiliation': 'Athletic Training Education Program, Department of Health Exercise and Sports Sciences, University of New Mexico, New Mexico, USA. Electronic address: diceshibata@unm.edu.'}]",Gait & posture,['10.1016/j.gaitpost.2020.05.044'] 1644,32501612,"Circulating adhesion molecules and associations with HbA1c, hypertension, nephropathy, and retinopathy in the Treatment Options for type 2 Diabetes in Adolescent and Youth study.","BACKGROUND The Treatment Options for type 2 Diabetes in Adolescent and Youth study, a randomized clinical trial of three treatments for type 2 diabetes (T2DM) in youth, demonstrated treatment failure (defined as sustained HbA1c ≥8%, or inability to wean insulin after 3 months after acute metabolic decomposition) in over half of the participants. Given that binding of mononuclear cells to vascular endothelium, initiated by cellular adhesion molecules and chemokines, is an early step in vascular injury, we sought to evaluate (a) changes in cellular adhesion molecule levels during the trial; (b) effect of diabetes treatment; and (c) association of markers with HbA1c, hypertension, hypercholesterolemia, nephropathy, and retinopathy. METHODS Participants (n = 515 of 699) that had baseline assessment of adhesion molecules (monocyte chemoattractant protein-1 [MCP-1], vascular cell adhesion marker [VCAM], intercellular adhesion marker [ICAM], and E-Selectin) and at least one other assessment, measured at month 12, 24, or 36, were included. RESULTS Over 1 to 3 years, significant increases in MCP-1 and decreases in VCAM (both P < .0001) concentrations were found; however, no significant interactions were identified with treatment group for any molecule. For every 1% increase in HbA1c, ICAM increased by 1.8%, VCAM by 1.5%, and E-selectin by 6.8% (all P < .0001). E-selectin increased by 3.7% and 4.2% for every 10 mm Hg increase in systolic and diastolic blood pressure, respectively (both P < .0001). ICAM was 10.2% higher and E-selectin was 15.5% higher in participants with microalbuminuria (both P < .01). There was no significant association of adhesion molecule levels with retinopathy. CONCLUSION Concentrations of cellular adhesion molecules rise with increasing HbA1c in youth with T2DM, and are associated with blood pressure and microalbuminuria, markers of vascular injury.",2020,ICAM was 10.2% higher and E-selectin 15.5% higher in participants with microalbuminuria (both P < 0.01).,"['type 2 diabetes (T2DM) in youth, demonstrated treatment failure (defined as sustained HbA1c ≥8%, or inability to wean insulin after 3\u2009months after acute metabolic decomposition) in over half of the participants', 'Participants (n\xa0']",[],"['E-selectin', 'adhesion molecules (MCP-1, VCAM, ICAM, and E-Selectin', 'systolic and diastolic blood pressure', 'HbA1c, ICAM', 'ICAM', 'MCP-1 and decreases in VCAM ']","[{'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0521983', 'cui_str': 'Absence of therapeutic response'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0043084', 'cui_str': 'Weaning'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}]",[],"[{'cui': 'C0115305', 'cui_str': 'Lymphocyte antigen CD62E'}, {'cui': 'C0007578', 'cui_str': 'Cell Adhesion Molecules'}, {'cui': 'C0128897', 'cui_str': 'Monocyte Chemoattractant Protein-1'}, {'cui': 'C0078056', 'cui_str': 'Lymphocyte antigen CD106'}, {'cui': 'C0242565', 'cui_str': 'Intercellular Adhesion Molecules'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}]",2.0,0.0525065,ICAM was 10.2% higher and E-selectin 15.5% higher in participants with microalbuminuria (both P < 0.01).,"[{'ForeName': 'Jeanie B', 'Initials': 'JB', 'LastName': 'Tryggestad', 'Affiliation': 'Department of Diabetes and Endocrinology, University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, USA.'}, {'ForeName': 'Rachana D', 'Initials': 'RD', 'LastName': 'Shah', 'Affiliation': ""Department of Pediatrics, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, USA.""}, {'ForeName': 'Barbara H', 'Initials': 'BH', 'LastName': 'Braffett', 'Affiliation': 'The Biostatistics Center, George Washington University, Rockville, Maryland, USA.'}, {'ForeName': 'Fida', 'Initials': 'F', 'LastName': 'Bacha', 'Affiliation': 'Department of Diabetes and Endocrinology, Baylor College of Medicine, Houston, Texas, USA.'}, {'ForeName': 'Samuel S', 'Initials': 'SS', 'LastName': 'Gidding', 'Affiliation': 'FH Foundation, Pasadena, California, USA.'}, {'ForeName': 'Rose A', 'Initials': 'RA', 'LastName': 'Gubitosi-Klug', 'Affiliation': 'Department of Pediatric Endocrinology, Diabetes and Metabolism, Case Western Reserve University, Cleveland, Ohio, USA.'}, {'ForeName': 'Amy S', 'Initials': 'AS', 'LastName': 'Shah', 'Affiliation': ""Division of Endocrinology, Cincinnati Children's Hospital and the University of Cincinnati, Cincinnati, Ohio, USA.""}, {'ForeName': 'Elaine M', 'Initials': 'EM', 'LastName': 'Urbina', 'Affiliation': ""Division of Endocrinology, Cincinnati Children's Hospital and the University of Cincinnati, Cincinnati, Ohio, USA.""}, {'ForeName': 'Lorraine E', 'Initials': 'LE', 'LastName': 'Levitt Katz', 'Affiliation': ""Department of Pediatrics, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, USA.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Pediatric diabetes,['10.1111/pedi.13062'] 1645,32501914,"Effect of Intravenous Aminocaproid Acid on Blood Loss and Transfusion Requirements After Bilateral Varus Rotational Osteotomy: A Double-blind, Placebo-controlled Randomized Trial.","BACKGROUND ε-Aminocaproic acid (EACA) is an antifibrinolytic agent that has been shown to decrease blood loss and transfusion requirements in several populations undergoing various surgical procedures. However, the efficacy of EACA has not been assessed in pediatric patients with cerebral palsy undergoing bilateral varus rotational femoral osteotomies. The purpose of this study was to assess the efficacy of intravenous EACA in reducing calculated intraoperative blood loss and transfusions in this population. METHODS Patients aged 18 years or younger were eligible. Patients were randomized to receive EACA or placebo (saline), and randomization was stratified based on sex and whether or not additional soft tissue or osseous procedures were performed. On the basis of retrospective data, the calculated sample size was 12 patients per arm to detect a difference of 250-mL blood loss. The primary outcome was calculated intraoperative blood loss. Secondary outcomes included transfusion requirements, 24-hour drain output, length of stay, and incidence of complications. RESULTS The mean age of patients in this study was 8 years (SD: 2.4 y). There were no differences in age, sex, height, weight, type of anesthesia, operative time, and associated procedures between the EACA and placebo groups (P>0.05). Preoperative hematocrit was lower in the EACA group (37.1 vs. 40.0, P=0.04). Calculated intraoperative blood loss was 536 mL in the EACA group and 628 mL in the placebo group (P=0.45). Transfusions were required in 62% of patients in the EACA group and 67% of patients in the placebo group (P=0.68). Total 24-hour drain output was 72.5 mL in the EACA group and 103.3 mL in the placebo group (P=0.37). Length of stay was similar between both groups, and there were no drug or placebo-related complications in either group. CONCLUSIONS There was no difference in blood loss or transfusion requirements associated with EACA compared with placebo; however, this study is underpowered to detect smaller differences in blood loss. Additional studies with larger sample sizes are needed to confirm these findings and further elucidate the indications for antifibrinolytic agents in pediatric patients. LEVEL OF EVIDENCE Level I.",2020,Transfusions were required in 62% of patients in the EACA group and 67% of patients in the placebo group (P=0.68).,"['several populations undergoing various surgical procedures', 'pediatric patients', 'After Bilateral Varus Rotational Osteotomy', 'Patients aged 18 years or younger were eligible', 'pediatric patients with cerebral palsy undergoing bilateral varus rotational femoral osteotomies']","['Placebo', 'ε-Aminocaproic acid (EACA', 'EACA', 'EACA or placebo (saline', 'Intravenous Aminocaproid Acid', 'placebo']","['Length of stay', 'blood loss or transfusion requirements', 'Total 24-hour drain output', 'Preoperative hematocrit', '250-mL blood loss', 'Blood Loss and Transfusion Requirements', 'blood loss and transfusion requirements', 'Transfusions', 'calculated intraoperative blood loss', 'transfusion requirements, 24-hour drain output, length of stay, and incidence of complications', 'blood loss', 'Calculated intraoperative blood loss']","[{'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0443345', 'cui_str': 'Varus'}, {'cui': 'C0407433', 'cui_str': 'Rotational osteotomy'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0007789', 'cui_str': 'Cerebral palsy'}, {'cui': 'C0445237', 'cui_str': 'Rotational'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}, {'cui': 'C0029468', 'cui_str': 'Osteotomy'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0000608', 'cui_str': '6-Aminocaproic Acid'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0001128', 'cui_str': 'Acid'}]","[{'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0013103', 'cui_str': 'Drainage procedure'}, {'cui': 'C3251815', 'cui_str': 'Measurement of fluid output'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0018935', 'cui_str': 'Hematocrit determination'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0444686', 'cui_str': 'Calculated'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",,0.423115,Transfusions were required in 62% of patients in the EACA group and 67% of patients in the placebo group (P=0.68).,"[{'ForeName': 'Ishaan', 'Initials': 'I', 'LastName': 'Swarup', 'Affiliation': ""Division of Pediatric Orthopaedic Surgery, University of California, San Francisco, UCSF Benioff Children's Hospital Oakland, Oakland, CA.""}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Nguyen', 'Affiliation': 'Healthcare Research Institute.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Edmonds', 'Affiliation': 'Division of Anesthesiology.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Dodwell', 'Affiliation': 'Division of Pediatric Orthopaedic Surgery, Hospital for Special Surgery, New York, NY.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Scher', 'Affiliation': 'Division of Pediatric Orthopaedic Surgery, Hospital for Special Surgery, New York, NY.'}]",Journal of pediatric orthopedics,['10.1097/BPO.0000000000001480'] 1646,32501985,Influences of different dose of tirofiban for acute ST elevation myocardial infarction patients underwent percutaneous coronary intervention.,"Tirofiban is widely used in patients with acute ST elevation myocardial infarction (STEMI) underwent percutaneous coronary intervention (PCI). This drug can efficiently improve myocardial perfusion and cardiac function, but its dose still remains controversial. We here investigated the effects of different dose of tirofiban on myocardial reperfusion and heart function in patients with STEMI. A total of 312 STEMI patients who underwent PCI in our hospital from March 2017 to March 2018 were enrolled and randomly divided into control group (75 cases, 0 μg/kg), low-dose group (79 cases, 5 μg/kg), medium-dose group (81 cases, 10 μg/kg) and high-dose group (77 cases, 20 μg/kg). The infarction-targeted artery flow grade evaluated by thrombolysis in myocardial infarction (TIMI), corrected TIMI frame count (CTFC) and sum-ST-segment resolution were recorded. At Day 7 and Day 30 after PCI, the left ventricular ejection fraction (LVEF), left ventricular end diastolic diameter, left ventricular end systolic diameter, major adverse cardiovascular events and the hemorrhage and thrombocytopenia were also evaluated. After PCI, the rate of TIMI grade 3, CTFC and incidence of sum-ST-segment resolution > 50% of high-dose group were significantly higher than those of control group, low-dose group and medium-dose group (P < .05), and the CTFC of medium -dose group were significantly higher than that of control group, low-dose group (P < .05). Moreover, the LVEF, left ventricular end diastolic diameter and left ventricular end systolic diameter of high-dose group were significantly improved than those of other groups, and the LVEF of medium-dose group was significantly superior to that of low-dose group (P < .05). However, the incidence of major adverse cardiac events in high-dose group was significantly decreased, while the hemorrhage and incidence of thrombocytopenia of high-dose group were significantly higher than those of other 3 groups (P < .05). The tirofiban can effectively alleviate the myocardial ischemia-reperfusion injury and promote the recovery of cardiac function in STEMI patients underwent PCI. Although the high-dose can enhance the clinical effects, it also increased the hemorrhagic risk. Therefore, the rational dosage application of tirofiban become much indispensable in view of patient's conditions and hemorrhagic risk, and a medium dose of 10 μg/kg may be appropriate for patients without high hemorrhagic risk.",2020,"After PCI, the rate of TIMI grade 3, CTFC and incidence of sum-ST-segment resolution > 50% of high-dose group were significantly higher than those of control group, low-dose group and medium-dose group (P < .05), and the CTFC of medium -dose group were significantly higher than that of control group, low-dose group (P < .05).","['acute ST elevation myocardial infarction patients underwent percutaneous coronary intervention', 'patients without high hemorrhagic risk', 'patients with STEMI', '312 STEMI patients who underwent PCI in our hospital from March 2017 to March 2018', 'patients with acute ST elevation myocardial infarction (STEMI) underwent percutaneous coronary intervention (PCI']","['tirofiban', 'Tirofiban']","['infarction-targeted artery flow grade evaluated by thrombolysis in myocardial infarction (TIMI), corrected TIMI frame count (CTFC) and sum-ST-segment resolution', 'left ventricular ejection fraction (LVEF), left ventricular end diastolic diameter, left ventricular end systolic diameter, major adverse cardiovascular events and the hemorrhage and thrombocytopenia', 'incidence of major adverse cardiac events', 'myocardial perfusion and cardiac function', 'rate of TIMI grade 3, CTFC and incidence of sum-ST-segment resolution', 'hemorrhage and incidence of thrombocytopenia', 'LVEF, left ventricular end diastolic diameter and left ventricular end systolic diameter', 'myocardial reperfusion and heart function', 'hemorrhagic risk']","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C1303258', 'cui_str': 'Acute ST segment elevation myocardial infarction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0333275', 'cui_str': 'Hemorrhagic'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C4517706', 'cui_str': '312'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0247025', 'cui_str': 'tirofiban'}]","[{'cui': 'C0021308', 'cui_str': 'Infarct'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0520997', 'cui_str': 'Thrombolysis'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0080089', 'cui_str': 'Reading Frames'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0429029', 'cui_str': 'ST segment'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0040034', 'cui_str': 'Thrombocytopenic disorder'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0428857', 'cui_str': 'Myocardial perfusion'}, {'cui': 'C0232164', 'cui_str': 'Cardiac function'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0027054', 'cui_str': 'Reperfusion, Myocardial'}, {'cui': 'C0333275', 'cui_str': 'Hemorrhagic'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",312.0,0.0198557,"After PCI, the rate of TIMI grade 3, CTFC and incidence of sum-ST-segment resolution > 50% of high-dose group were significantly higher than those of control group, low-dose group and medium-dose group (P < .05), and the CTFC of medium -dose group were significantly higher than that of control group, low-dose group (P < .05).","[{'ForeName': 'Haixia', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Department Pharmacy, the Second Clinical Hospital of Shanxi Medical University, Taiyuan, Shanxi.'}, {'ForeName': 'Meiqin', 'Initials': 'M', 'LastName': 'Feng', 'Affiliation': 'AstraZeneca (Wuxi) trading co. LTD, Wuxi, Jiangsu, China.'}]",Medicine,['10.1097/MD.0000000000020402'] 1647,32503602,Two Randomized Controlled Trials of Bacillus Calmette-Guérin Vaccination to reduce absenteeism among health care workers and hospital admission by elderly persons during the COVID-19 pandemic: A structured summary of the study protocols for two randomised controlled trials.,"OBJECTIVES The objectives of these two separate trials are: (1) to reduce health care workers (HCWs) absenteeism; and (2) to reduce hospital admission among the elderly during the COVID-19 pandemic through BCG vaccination. TRIAL DESIGN Two separate multi-centre placebo-controlled parallel group randomized trials PARTICIPANTS: (1) Health care personnel working in the hospital or ambulance service where they will take care of patients with the COVID-19 infection and (2) elderly ≥60 years. The HCW trial is being undertaken in 9 hospitals. The elderly trial is being undertaken in locations in the community in Nijmegen, Utrecht, and Veghel, in the Netherlands, using senior citizen organisations to facilitate recruitment. INTERVENTION AND COMPARATOR For both trials the intervention group will be randomized to vaccination with 0.1 ml of the licensed BCG vaccine (Danish strain 1331, SSI, Denmark, equivalent to 0.075 mg attenuated M. bovis). The placebo group consists of 0.1 ml 0.9% NaCl, which is the same amount, and has the same colour and appearance as the suspended BCG vaccine. MAIN OUTCOMES (1) Number of days of unplanned work absenteeism in HCWs for any reason which can be continuously measured on a bi-weekly basis, and (2) the cumulative incidence of hospital admission due to documented COVID-19. RANDOMISATION Participants will be randomized to BCG vaccine or placebo (1;1) centrally using a computer- based system, stratified by study centre. BLINDING (MASKING) Subjects, investigators, physicians and outcome assessors are blinded for the intervention. Only the pharmacist assistant that prepares- and research personnel that administers- study medicines are unblinded. NUMBERS TO BE RANDOMISED (SAMPLE SIZE): (1) The sample size for the first trial is N=1500 HCWs randomised 1:1 to either BCG vaccine (n=750) and placebo (n=750) and (2) The sample size for the second trial is N=1600 elderly persons randomised to BCG vaccine (n=800) and the placebo group (n=800). TRIAL STATUS HCW: version 4.0, 24-04-2020. Recruitment began 25-03-2020 and was completed on the 23-04-2020. Elderly: version 3.0, 04-04-2020. Recruitment began 16-04- 2020 and is ongoing. TRIAL REGISTRATION The HCWs trial was registered 31-03-2020 at clinicaltrials.gov (identifier: NCT04328441) and registered 20-03-2020 at the Dutch Trial Registry (trialregister.nl, identifier Trial NL8477). The elderly trial was registered 22-04-2020 at the Dutch trial registry with number NL8547. FULL PROTOCOL The full protocols will be attached as additional files, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.",2020,"MAIN OUTCOMES (1) Number of days of unplanned work absenteeism in HCWs for any reason which can be continuously measured on a bi-weekly basis, and (2) the cumulative incidence of hospital admission due to documented COVID-19. ","['N=1600 elderly persons randomised to', 'The elderly trial was registered 22-04-2020 at the Dutch trial registry with number NL8547', 'Recruitment began 25-03-2020 and was completed on the 23-04-2020', 'patients with the COVID-19 infection and (2) elderly ≥60 years', 'HCW: version 4.0, 24-04-2020', 'health care workers and hospital admission by elderly persons during the COVID-19 pandemic']","['Bacillus Calmette-Guérin Vaccination', 'BCG vaccine', 'BCG vaccine or placebo', 'placebo']","['cumulative incidence of hospital admission', '1) Number of days of unplanned work absenteeism in HCWs']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0013331', 'cui_str': 'Dutch'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C1615608', 'cui_str': 'Pandemics'}]","[{'cui': 'C0004587', 'cui_str': 'Bacillus'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0004886', 'cui_str': 'BCG vaccine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0000849', 'cui_str': 'Absenteeism'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}]",,0.395304,"MAIN OUTCOMES (1) Number of days of unplanned work absenteeism in HCWs for any reason which can be continuously measured on a bi-weekly basis, and (2) the cumulative incidence of hospital admission due to documented COVID-19. ","[{'ForeName': 'Thijs', 'Initials': 'T', 'LastName': 'Ten Doesschate', 'Affiliation': 'University Medical Center, Utrecht, The Netherlands. t.tendoesschate@umcutrecht.nl.'}, {'ForeName': 'Simone J C F M', 'Initials': 'SJCFM', 'LastName': 'Moorlag', 'Affiliation': 'Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'Thomas W', 'Initials': 'TW', 'LastName': 'van der Vaart', 'Affiliation': 'University Medical Center, Utrecht, The Netherlands.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Taks', 'Affiliation': 'Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'Priya', 'Initials': 'P', 'LastName': 'Debisarun', 'Affiliation': 'Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'Jaap', 'Initials': 'J', 'LastName': 'Ten Oever', 'Affiliation': 'Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'Chantal P', 'Initials': 'CP', 'LastName': 'Bleeker-Rovers', 'Affiliation': 'Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'Patricia Bruijning', 'Initials': 'PB', 'LastName': 'Verhagen', 'Affiliation': 'University Medical Center, Utrecht, The Netherlands.'}, {'ForeName': 'Arief', 'Initials': 'A', 'LastName': 'Lalmohamed', 'Affiliation': 'University Medical Center, Utrecht, The Netherlands.'}, {'ForeName': 'Rob', 'Initials': 'R', 'LastName': 'Ter Heine', 'Affiliation': 'Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'Reinout', 'Initials': 'R', 'LastName': 'van Crevel', 'Affiliation': 'Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': 'Janneke', 'Initials': 'J', 'LastName': 'van de Wijgert', 'Affiliation': 'University Medical Center, Utrecht, The Netherlands.'}, {'ForeName': 'Axel B', 'Initials': 'AB', 'LastName': 'Janssen', 'Affiliation': 'University Medical Center, Utrecht, The Netherlands.'}, {'ForeName': 'Marc J', 'Initials': 'MJ', 'LastName': 'Bonten', 'Affiliation': 'University Medical Center, Utrecht, The Netherlands.'}, {'ForeName': 'Cornelis H', 'Initials': 'CH', 'LastName': 'van Werkhoven', 'Affiliation': 'University Medical Center, Utrecht, The Netherlands.'}, {'ForeName': 'Mihai G', 'Initials': 'MG', 'LastName': 'Netea', 'Affiliation': 'Radboud University Medical Center, Nijmegen, the Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Trials,['10.1186/s13063-020-04389-w'] 1648,32503663,Sargramostim to treat patients with acute hypoxic respiratory failure due to COVID-19 (SARPAC): A structured summary of a study protocol for a randomised controlled trial.,"OBJECTIVES The hypothesis of the proposed intervention is that Granulocyte-macrophage colony-stimulating factor (GM-CSF) has profound effects on antiviral immunity, and can provide the stimulus to restore immune homeostasis in the lung with acute lung injury post COVID-19, and can promote lung repair mechanisms, that lead to a 25% improvement in lung oxygenation parameters. Sargramostim is a man-made form of the naturally-occurring protein GM-CSF. TRIAL DESIGN A phase 4 academic, prospective, 2 arm (1:1 ratio), randomized, open-label, controlled trial. PARTICIPANTS Patients aged 18-80 years admitted to specialized COVID-19 wards in 5 Belgian hospitals with recent (< 2 weeks prior to randomization) confirmed COVID-19 infection and acute respiratory failure defined as a PaO2/FiO2 below 350 mmHg or SpO2 below 93% on minimal 2 L/min supplemental oxygen. Patients were excluded from the trial in case of (1) known serious allergic reactions to yeast-derived products, (2) lithium carbonate therapy, (3) mechanical ventilation prior to randomization, (4) peripheral white blood cell count above 25.000/μL and/or active myeloid malignancy, (5) high dose systemic steroid therapy (> 20 mg methylprednisolone or equivalent), (6) enrolment in another investigational study, (7) pregnant or breastfeeding or (8) ferritin levels > 2000 μg/mL. INTERVENTION AND COMPARATOR Inhaled sargramostim 125 μg twice daily for 5 days in addition to standard care. Upon progression of disease requiring mechanical ventilation or to acute respiratory distress syndrome (ARDS) and initiation of mechanical ventilator support within the 5 day period, inhaled sargramostim will be replaced by intravenous sargramostim 125 μg/m 2 body surface area once daily until the 5 day period is reached. From day 6 onwards, progressive patients in the active group will have the option to receive an additional 5 days of IV sargramostim, based on the treating physician's assessment. Intervention will be compared to standard of care. Subjects progressing to ARDS and requiring invasive mechanical ventilatory support, from day 6 onwards in the standard of care group will have the option (clinician's decision) to initiate IV sargramostim 125m μg/m 2 body surface area once daily for 5 days. MAIN OUTCOMES The primary endpoint of this intervention is measuring oxygenation after 5 days of inhaled (and intravenous) treatment through assessment of a change in pretreatment and post-treatment ratio of PaO2/FiO2 and through measurement of the P(A-a)O2 gradient (PAO2= Partial alveolar pressure of oxygen, PaO2=Partial arterial pressure of oxygen; FiO2= Fraction of inspired oxygen). RANDOMISATION Patients will be randomized in a 1:1 ratio. Randomization will be done using REDCap (electronic IWRS system). BLINDING (MASKING) In this open-label trial neither participants, caregivers, nor those assessing the outcomes will be blinded to group assignment. NUMBERS TO BE RANDOMISED (SAMPLE SIZE) A total of 80 patients with confirmed COVID-19 and acute hypoxic respiratory failure will be enrolled, 40 in the active and 40 in the control group. TRIAL STATUS SARPAC protocol Version 2.0 (April 15 2020). Participant recruitment is ongoing in 5 Belgian Hospitals (i.e. University Hospital Ghent, AZ Sint-Jan Bruges, AZ Delta Roeselare, University Hospital Brussels and ZNA Middelheim Antwerp). Participant recruitment started on March 26 th 2020. Given the current decline of the COVID-19 pandemic in Belgium, it is difficult to anticipate the rate of participant recruitment. TRIAL REGISTRATION The trial was registered on Clinical Trials.gov on March 30 th , 2020 (ClinicalTrials.gov Identifier: NCT04326920) - retrospectively registered; https://clinicaltrials.gov/ct2/show/NCT04326920?term=sarpac&recrs=ab&draw=2&rank=1 and on EudraCT on March 24th, 2020 (Identifier: 2020-001254-22). FULL PROTOCOL The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.",2020,"In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.","['Patients aged 18-80 years admitted to specialized COVID-19 wards in 5 Belgian hospitals with recent (< 2 weeks prior to randomization) confirmed COVID-19 infection and acute respiratory failure defined as a', 'on March 24th, 2020', 'Patients were excluded from the trial in case of (1) known serious allergic reactions to yeast-derived products, (2) lithium carbonate therapy, (3) mechanical ventilation prior to randomization, (4) peripheral white blood cell count above 25.000/μL and/or active myeloid malignancy, (5) high dose systemic steroid therapy (> 20 mg methylprednisolone or equivalent), (6) enrolment in another investigational study, (7) pregnant or breastfeeding or (8) ferritin levels ', '2000', 'patients with acute hypoxic respiratory failure due to COVID-19 (SARPAC', '80 patients with confirmed COVID-19 and acute hypoxic respiratory failure will be enrolled, 40 in the active and 40 in the control group']","['https://clinicaltrials.gov/ct2/show/NCT04326920?term=sarpac&recrs=ab&draw=2&rank=1 and on EudraCT', 'Sargramostim', 'Inhaled sargramostim', 'PaO2/FiO2 below 350 mmHg or SpO2 below 93% on minimal 2 L/min supplemental oxygen']","['measuring oxygenation after 5 days of inhaled (and intravenous) treatment through assessment of a change in pretreatment and post-treatment ratio of PaO2/FiO2 and through measurement of the P(A-a)O2 gradient (PAO2= Partial alveolar pressure of oxygen, PaO2=Partial arterial pressure of oxygen; FiO2= Fraction of inspired oxygen']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C0337797', 'cui_str': 'Belgians'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0264490', 'cui_str': 'Acute respiratory failure'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0036025', 'cui_str': 'Saccharomyces cerevisiae'}, {'cui': 'C0085217', 'cui_str': 'Lithium Carbonate'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C2939461', 'cui_str': 'Myeloid neoplasm'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0149783', 'cui_str': 'Administration of steroid'}, {'cui': 'C0025815', 'cui_str': 'Methylprednisolone'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0373607', 'cui_str': 'Ferritin measurement'}, {'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C3805211', 'cui_str': 'Hypoxic respiratory failure'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0216231', 'cui_str': 'sargramostim'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C4517735', 'cui_str': '350'}, {'cui': 'C0439475', 'cui_str': 'mmHg'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0439393', 'cui_str': 'L/min'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}]","[{'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0232010', 'cui_str': 'Alveolar pressure'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0232108', 'cui_str': 'Arterial pulse pressure'}, {'cui': 'C0428167', 'cui_str': 'Fraction of inspired oxygen'}]",80.0,0.333777,"In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.","[{'ForeName': 'Cedric', 'Initials': 'C', 'LastName': 'Bosteels', 'Affiliation': 'VIB-UGent Inflammatie-researchcentrum, Oost-Vlaanderen, Ghent, Belgium.'}, {'ForeName': 'Bastiaan', 'Initials': 'B', 'LastName': 'Maes', 'Affiliation': 'VIB-UGent Inflammatie-researchcentrum, Oost-Vlaanderen, Ghent, Belgium. bastiaan.maes@irc.vib-ugent.be.'}, {'ForeName': 'Karel', 'Initials': 'K', 'LastName': 'Van Damme', 'Affiliation': 'VIB-UGent Inflammatie-researchcentrum, Oost-Vlaanderen, Ghent, Belgium.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'De Leeuw', 'Affiliation': 'VIB-UGent Inflammatie-researchcentrum, Oost-Vlaanderen, Ghent, Belgium.'}, {'ForeName': 'Jozefien', 'Initials': 'J', 'LastName': 'Declercq', 'Affiliation': 'VIB-UGent Inflammatie-researchcentrum, Oost-Vlaanderen, Ghent, Belgium.'}, {'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'Delporte', 'Affiliation': 'VIB-UGent Inflammatie-researchcentrum, Oost-Vlaanderen, Ghent, Belgium.'}, {'ForeName': 'Bénédicte', 'Initials': 'B', 'LastName': 'Demeyere', 'Affiliation': 'VIB-UGent Inflammatie-researchcentrum, Oost-Vlaanderen, Ghent, Belgium.'}, {'ForeName': 'Stéfanie', 'Initials': 'S', 'LastName': 'Vermeersch', 'Affiliation': 'VIB-UGent Inflammatie-researchcentrum, Oost-Vlaanderen, Ghent, Belgium.'}, {'ForeName': 'Marnik', 'Initials': 'M', 'LastName': 'Vuylsteke', 'Affiliation': 'VIB-UGent Inflammatie-researchcentrum, Oost-Vlaanderen, Ghent, Belgium.'}, {'ForeName': 'Joren', 'Initials': 'J', 'LastName': 'Willaert', 'Affiliation': 'VIB-UGent Inflammatie-researchcentrum, Oost-Vlaanderen, Ghent, Belgium.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Bollé', 'Affiliation': 'VIB-UGent Inflammatie-researchcentrum, Oost-Vlaanderen, Ghent, Belgium.'}, {'ForeName': 'Yuri', 'Initials': 'Y', 'LastName': 'Vanbiervliet', 'Affiliation': 'VIB-UGent Inflammatie-researchcentrum, Oost-Vlaanderen, Ghent, Belgium.'}, {'ForeName': 'Jana', 'Initials': 'J', 'LastName': 'Decuypere', 'Affiliation': 'VIB-UGent Inflammatie-researchcentrum, Oost-Vlaanderen, Ghent, Belgium.'}, {'ForeName': 'Frederick', 'Initials': 'F', 'LastName': 'Libeer', 'Affiliation': 'VIB-UGent Inflammatie-researchcentrum, Oost-Vlaanderen, Ghent, Belgium.'}, {'ForeName': 'Stefaan', 'Initials': 'S', 'LastName': 'Vandecasteele', 'Affiliation': 'VIB-UGent Inflammatie-researchcentrum, Oost-Vlaanderen, Ghent, Belgium.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Peene', 'Affiliation': 'VIB-UGent Inflammatie-researchcentrum, Oost-Vlaanderen, Ghent, Belgium.'}, {'ForeName': 'Bart', 'Initials': 'B', 'LastName': 'Lambrecht', 'Affiliation': 'VIB-UGent Inflammatie-researchcentrum, Oost-Vlaanderen, Ghent, Belgium.'}]",Trials,['10.1186/s13063-020-04451-7'] 1649,32507027,Locomotor Kinematics and Kinetics Following High-Intensity Stepping Training in Variable Contexts Poststroke.,"Background and Purpose . Previous studies suggest that individuals poststroke can achieve substantial gains in walking function following high-intensity locomotor training (LT). Recent findings also indicate practice of variable stepping tasks targeting locomotor deficits can mitigate selected impairments underlying reduced walking speeds. The goal of this study was to investigate alterations in locomotor biomechanics following 3 different LT paradigms. Methods . This secondary analysis of a randomized trial recruited individuals 18 to 85 years old and >6 months poststroke. We compared changes in spatiotemporal, joint kinematics, and kinetics following up to 30 sessions of high-intensity (>70% heart rate reserve [HRR]) LT of variable tasks targeting paretic limb and balance impairments (high-variable, HV), high-intensity LT focused only on forward walking (high-forward, HF), or low-intensity LT (<40% HRR) of variable tasks (low-variable, LV). Sagittal spatiotemporal and joint kinematics, and concentric joint powers were compared between groups. Regressions and principal component analyses were conducted to evaluate relative contributions or importance of biomechanical changes to between and within groups. Results . Biomechanical data were available on 50 participants who could walk ≥0.1 m/s on a motorized treadmill. Significant differences in spatiotemporal parameters, kinematic consistency, and kinetics were observed between HV and HF versus LV. Resultant principal component analyses were characterized by paretic powers and kinematic consistency following HV, while HF and LV were characterized by nonparetic powers. Conclusion . High-intensity LT results in greater changes in kinematics and kinetics as compared with lower-intensity interventions. The results may suggest greater paretic-limb contributions with high-intensity variable stepping training that targets specific biomechanical deficits. Clinical Trial Registration . https://clinicaltrials.gov/ Unique Identifier: NCT02507466.",2020,"Significant differences in spatiotemporal parameters, kinematic consistency, and kinetics were observed between HV and HF versus LV.","['individuals 18 to 85 years old and >6 months poststroke', '50 participants who could walk ≥0.1 m/s on a motorized treadmill']","['high-intensity variable stepping training', 'High-Intensity Stepping Training', 'https://clinicaltrials.gov']","['locomotor biomechanics', 'Sagittal spatiotemporal and joint kinematics, and concentric joint powers', 'spatiotemporal parameters, kinematic consistency, and kinetics']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0439493', 'cui_str': 'm/s'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}]","[{'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0205129', 'cui_str': 'Sagittal'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}, {'cui': 'C0439744', 'cui_str': 'Concentric'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0022702', 'cui_str': 'Kinetics'}]",50.0,0.0846158,"Significant differences in spatiotemporal parameters, kinematic consistency, and kinetics were observed between HV and HF versus LV.","[{'ForeName': 'Marzieh M', 'Initials': 'MM', 'LastName': 'Ardestani', 'Affiliation': 'Indiana University School of Medicine, Indianapolis IN, USA.'}, {'ForeName': 'Christopher E', 'Initials': 'CE', 'LastName': 'Henderson', 'Affiliation': 'Indiana University School of Medicine, Indianapolis IN, USA.'}, {'ForeName': 'Gordhan', 'Initials': 'G', 'LastName': 'Mahtani', 'Affiliation': 'Department of Orthopaedic Surgery, Stanford University, Palo Alto, CA, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Connolly', 'Affiliation': 'University of Chicago Medicine, Chicago, IL, USA.'}, {'ForeName': 'T George', 'Initials': 'TG', 'LastName': 'Hornby', 'Affiliation': 'Indiana University School of Medicine, Indianapolis IN, USA.'}]",Neurorehabilitation and neural repair,['10.1177/1545968320929675'] 1650,32505485,Neuroplastic changes in resting-state functional connectivity after rTMS intervention for methamphetamine craving.,"Amphetamine-type stimulants are the second most commonly abused illicit drug worldwide, with no effective medical treatments currently available. Previous studies have demonstrated that high frequency repetitive transcranial magnetic stimulation (rTMS) over the left dorsolateral prefrontal cortex (DLPFC) reduced cue-induced craving in patients with methamphetamine dependence. However, the neuroplastic mechanism underlying rTMS intervention in methamphetamine users remains to be elucidated. Sixty participants (40 males) with severe methamphetamine use disorder according to DSM-5 were randomized to receive either intermittent theta burst protocols (iTBS) (short bursts of 50 Hz rTMS repeated at a rate in the theta range (5 Hz), 2-sec on, 8-sec off for 5 min; 900 pulses) or sham rTMS over the DLPFC over four weeks (20 daily sessions). Resting state functional connectivity magnetic resonance imaging was acquired before and after rTMS intervention. Participants received drug related cue exposure and rated their craving before and after stimulation. Seed-based functional connectivity analysis was performed to probe rTMS-induced neuroplastic reorganization of brain functional networks. Results showed that twenty daily rTMS sessions decreased craving, increased functional connectivity between left DLPFC and inferior parietal lobule, and decreased functional connectivity between insula and inferior parietal lobule, medial temporal lobe and precuneus. Moreover, the increase of functional connectivity between DLPFC and inferior parietal lobule correlated with craving reduction. This study suggests that neuroplastic changes of frontoparietal functional connectivity contributes to craving reduction, shedding light on the therapeutic effect of rTMS on methamphetamine use disorder.",2020,"Results showed that twenty daily rTMS sessions decreased craving, increased functional connectivity between left DLPFC and inferior parietal lobule, and decreased functional connectivity between insula and inferior parietal lobule, medial temporal lobe and precuneus.","['patients with methamphetamine dependence', 'Sixty participants (40 males) with severe methamphetamine use disorder according to DSM-5']","['intermittent theta burst protocols (iTBS) (short bursts of 50\u202fHz rTMS repeated at a rate in the theta range (5\u202fHz), 2-sec on, 8-sec off for 5\u202fmin; 900 pulses) or sham rTMS', 'rTMS', 'rTMS intervention', 'repetitive transcranial magnetic stimulation (rTMS', 'Amphetamine-type stimulants']","['craving, increased functional connectivity between left DLPFC and inferior parietal lobule, and decreased functional connectivity between insula and inferior parietal lobule, medial temporal lobe and precuneus', 'functional connectivity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1533217', 'cui_str': 'Methamphetamine dependence'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1137105', 'cui_str': 'DSM-V'}]","[{'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0059387', 'cui_str': 'staphylococcal enterotoxin C'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C4517900', 'cui_str': '900'}, {'cui': 'C0034107', 'cui_str': 'Pulse taking'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0002658', 'cui_str': 'Amphetamine'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0002763', 'cui_str': 'Central stimulant'}]","[{'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C4019080', 'cui_str': 'Prefrontal Cortex, Dorsolateral'}, {'cui': 'C0152304', 'cui_str': 'Inferior parietal lobule structure'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0021640', 'cui_str': 'Insular structure'}, {'cui': 'C0205098', 'cui_str': 'Medial'}, {'cui': 'C0039485', 'cui_str': 'Temporal lobe structure'}]",60.0,0.0225991,"Results showed that twenty daily rTMS sessions decreased craving, increased functional connectivity between left DLPFC and inferior parietal lobule, and decreased functional connectivity between insula and inferior parietal lobule, medial temporal lobe and precuneus.","[{'ForeName': 'Hang', 'Initials': 'H', 'LastName': 'Su', 'Affiliation': 'Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Yilin', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Institute of Neuroscience, CAS Center for Excellence in Brain Science and Intelligence Technology, State Key Laboratory of Neuroscience, CAS Key Laboratory of Primate Neurobiology, Chinese Academy of Sciences, Shanghai, China; University of Chinese Academy of Sciences, Beijing, China.'}, {'ForeName': 'Dazhi', 'Initials': 'D', 'LastName': 'Yin', 'Affiliation': 'School of Psychology and Cognitive Science, East China Normal University, Shanghai, China.'}, {'ForeName': 'Tianzhen', 'Initials': 'T', 'LastName': 'Chen', 'Affiliation': 'Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Xiaotong', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Na', 'Initials': 'N', 'LastName': 'Zhong', 'Affiliation': 'Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Haifeng', 'Initials': 'H', 'LastName': 'Jiang', 'Affiliation': 'Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Jijun', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Jiang', 'Initials': 'J', 'LastName': 'Du', 'Affiliation': 'Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Ke', 'Initials': 'K', 'LastName': 'Xiao', 'Affiliation': 'Shanghai Drug Rehabilitation Administration Bureau, Shanghai, China.'}, {'ForeName': 'Ding', 'Initials': 'D', 'LastName': 'Xu', 'Affiliation': 'Shanghai Drug Rehabilitation Administration Bureau, Shanghai, China.'}, {'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Zeljic', 'Affiliation': 'Institute of Neuroscience, CAS Center for Excellence in Brain Science and Intelligence Technology, State Key Laboratory of Neuroscience, CAS Key Laboratory of Primate Neurobiology, Chinese Academy of Sciences, Shanghai, China.'}, {'ForeName': 'Zheng', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Institute of Neuroscience, CAS Center for Excellence in Brain Science and Intelligence Technology, State Key Laboratory of Neuroscience, CAS Key Laboratory of Primate Neurobiology, Chinese Academy of Sciences, Shanghai, China; University of Chinese Academy of Sciences, Beijing, China; CAS Center for Excellence in Brain Science and Intelligence Technology, Chinese Academy of Sciences, Shanghai, 200031, China. Electronic address: zheng.wang@ion.ac.cn.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Zhao', 'Affiliation': 'Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China; CAS Center for Excellence in Brain Science and Intelligence Technology, Chinese Academy of Sciences, Shanghai, 200031, China; Shanghai Key Laboratory of Psychotic Disorders, Shanghai, China; Institute of Psychological and Behavioral Science, Shanghai Jiao Tong University, Shanghai, China. Electronic address: drminzhao@smhc.org.cn.'}]",Neuropharmacology,['10.1016/j.neuropharm.2020.108177'] 1651,32505660,Frontal-midline theta frequency and probabilistic learning: A transcranial alternating current stimulation study.,"Probabilistic learning is a fundamental cognitive ability that extracts and represents regularities of our environment enabling predictive processing during perception and acquisition of perceptual, motor, cognitive, and social skills. Previous studies show competition between neural networks related to executive function/working memory vs. probabilistic learning. Theta synchronization has been associated with the former while desynchronization with the latter in correlational studies. In the present paper our aim was to test causal relationship between fronto-parietal midline theta synchronization and probabilistic learning with non-invasive transcranial alternating current (tACS) stimulation. We hypothesize that theta synchronization disrupts probabilistic learning performance by modulating the competitive relationship. Twenty-six young adults performed the Alternating Serial Reaction Time (ASRT) task to assess probabilistic learning in two sessions that took place one week apart. Stimulation was applied in a double-blind cross-over within-subject design with an active theta tACS and a sham stimulation in a counter-balanced order between participants. Sinusoidal current was administered with 1 mA peak-to-peak intensity throughout the task (approximately 20 min) for the active stimulation and 30 s for the sham. We did not find an effect of fronto-parietal midline theta tACS on probabilistic learning comparing performance during active and sham stimulation. To influence probabilistic learning, we suggest applying higher current intensity and stimulation parameters more precisely aligned to endogenous brain activity for future studies.",2020,We did not find an effect of fronto-parietal midline theta tACS on probabilistic learning comparing performance during active and sham stimulation.,['Twenty-six young adults'],"['fronto-parietal midline theta synchronization and probabilistic learning with non-invasive transcranial alternating current (tACS) stimulation', 'probabilistic learning', 'fronto-parietal midline theta tACS', 'Probabilistic learning', 'Alternating Serial Reaction Time (ASRT) task to assess probabilistic learning']",['probabilistic learning performance'],"[{'cui': 'C0450349', 'cui_str': '26'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C0442030', 'cui_str': 'Parietal'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0439580', 'cui_str': 'Synchronous'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0205303', 'cui_str': 'Non-invasive'}, {'cui': 'C3852966', 'cui_str': 'Transcranial Alternating Current Stimulation'}, {'cui': 'C3489891', 'cui_str': 'TAC Alternate'}, {'cui': 'C0332270', 'cui_str': 'Alternating'}, {'cui': 'C0031082', 'cui_str': 'Periodicals'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}]","[{'cui': 'C0013621', 'cui_str': 'Education'}]",26.0,0.103353,We did not find an effect of fronto-parietal midline theta tACS on probabilistic learning comparing performance during active and sham stimulation.,"[{'ForeName': 'Zsófia', 'Initials': 'Z', 'LastName': 'Zavecz', 'Affiliation': 'Doctoral School of Psychology, ELTE Eötvös Loránd University, Budapest, Hungary; Institute of Psychology, ELTE Eötvös Loránd University, Budapest, Hungary; Brain, Memory and Language Research Group, Institute of Cognitive Neuroscience and Psychology, Research Centre for Natural Sciences, Hungarian Academy of Sciences, Budapest, Hungary.'}, {'ForeName': 'Kata', 'Initials': 'K', 'LastName': 'Horváth', 'Affiliation': 'Doctoral School of Psychology, ELTE Eötvös Loránd University, Budapest, Hungary; Institute of Psychology, ELTE Eötvös Loránd University, Budapest, Hungary; Brain, Memory and Language Research Group, Institute of Cognitive Neuroscience and Psychology, Research Centre for Natural Sciences, Hungarian Academy of Sciences, Budapest, Hungary.'}, {'ForeName': 'Péter', 'Initials': 'P', 'LastName': 'Solymosi', 'Affiliation': 'Institute of Psychology, ELTE Eötvös Loránd University, Budapest, Hungary.'}, {'ForeName': 'Karolina', 'Initials': 'K', 'LastName': 'Janacsek', 'Affiliation': 'Institute of Psychology, ELTE Eötvös Loránd University, Budapest, Hungary; Brain, Memory and Language Research Group, Institute of Cognitive Neuroscience and Psychology, Research Centre for Natural Sciences, Hungarian Academy of Sciences, Budapest, Hungary; Centre of Thinking and Learning, Institute for Lifecourse Development, School of Human Sciences, University of Greenwich, London, United Kingdom.'}, {'ForeName': 'Dezso', 'Initials': 'D', 'LastName': 'Nemeth', 'Affiliation': 'Institute of Psychology, ELTE Eötvös Loránd University, Budapest, Hungary; Brain, Memory and Language Research Group, Institute of Cognitive Neuroscience and Psychology, Research Centre for Natural Sciences, Hungarian Academy of Sciences, Budapest, Hungary; Lyon Neuroscience Research Center (CRNL), INSERM, CNRS, Université Claude Bernard Lyon 1, Lyon, France. Electronic address: dezso.nemeth@univ-lyon1.fr.'}]",Behavioural brain research,['10.1016/j.bbr.2020.112733'] 1652,32512184,"Accelerated iTBS treatment applied to the left DLPFC in depressed patients results in a rapid volume increase in the left hippocampal dentate gyrus, not driven by brain perfusion.","BACKGROUND Accelerated intermittent Theta Burst Stimulation (aiTBS) has been shown to be an effective antidepressant treatment. Although neurobiological changes shortly after this intervention have been reported, whether aiTBS results in structural brain changes must still be determined. Furthermore, it possible that rapid volumetric changes are driven by factors other than neurotrophic processes. OBJECTIVES We examined whether possible grey matter volumetric (GMV) increases after aiTBS treatment could be driven by increased brain perfusion, measured by Arterial Spin Labeling (ASL). METHODS 46 treatment-resistant depressed patients were randomized to receive 20 sessions of active or sham iTBS applied to the left dorsolateral prefrontal cortex. All sessions were delivered over 4 days at 5 sessions per day (trial registration: http://clinicaltrials.gov/show/NCT01832805). Patients were scanned the day before starting stimulation and three days after aiTBS. RESULTS There was a significant cluster of increased left hippocampal GMV in the dentate gyrus related to HRSD changes after active aiTBS, but not after sham stimulation. These GMV increases became more pronounced when accounting for changes in cerebral perfusion. CONCLUSIONS Active, but not sham, aiTBS, resulted in acute volumetric changes in parts of the left dentate gyrus, suggesting a connection with adult neurogenesis. Furthermore, taking cerebral perfusion measurements into account impacts on detection of the GMV changes. Whether these hippocampal volumetric changes produced by active aiTBS are necessary for long-term clinical improvement remains to be determined.",2020,"There was a significant cluster of increased left hippocampal GMV in the dentate gyrus related to HRSD changes after active aiTBS, but not after sham stimulation.",['46 treatment-resistant depressed patients'],"['Accelerated intermittent Theta Burst Stimulation (aiTBS', '20 sessions of active or sham iTBS']","['Arterial Spin Labeling (ASL', 'left hippocampal GMV']","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0019564', 'cui_str': 'Hippocampal structure'}, {'cui': 'C0018220', 'cui_str': 'Grey Matter'}, {'cui': 'C0445383', 'cui_str': 'Volumetric'}]",46.0,0.102893,"There was a significant cluster of increased left hippocampal GMV in the dentate gyrus related to HRSD changes after active aiTBS, but not after sham stimulation.","[{'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Baeken', 'Affiliation': 'Ghent University, Department of Psychiatry and Medical Psychology, Ghent Experimental Psychiatry (GHEP) Lab, Ghent, Belgium; Vrije Universiteit Brussel (VUB), Department of Psychiatry, Universitair Ziekenhuis Brussel (UZBrussel), Laarbeeklaan 101, 1090, Brussels, Belgium; Eindhoven University of Technology, Department of Electrical Engineering, Eindhoven, the Netherlands.'}, {'ForeName': 'GuoRong', 'Initials': 'G', 'LastName': 'Wu', 'Affiliation': 'Key Laboratory of Cognition and Personality, Faculty of Psychology, Southwest University, Chongqing, China. Electronic address: guorongwu@swu.edu.cn.'}, {'ForeName': 'Harold A', 'Initials': 'HA', 'LastName': 'Sackeim', 'Affiliation': 'Columbia University, Department of Psychiatry, New York, NY, USA; Columbia University, Department of Radiology, New York, NY, USA.'}]",Brain stimulation,['10.1016/j.brs.2020.05.015'] 1653,32512234,Oxygen supplementation increases the total work and muscle damage markers but reduces the inflammatory response in COPD patients.,"INTRODUCTION Oxygen supplementation (O 2 -Suppl) is recommended for pulmonary rehabilitation with higher exercise intensities. However, high-intensity exercise tends toward muscle damage and a greater inflammatory response. We aimed to investigate the effect of O 2 -Suppl during exercise test (EET) on CRP level and muscle damage (CPK, LDH, lactate) in non-hypoxemic COPD patients. METHODS Eleven non-depleted patients with COPD (FEV 1 65.5 ± 4.3 %) performed two EET (room-air or O 2 -Suppl-100 %), through a blind, randomized, and placebo-controlled crossover design. CPK, LDH and CRP were measured before, immediately after and 24 h after EET. RESULTS Exercise time was higher with O 2 -Suppl (49.9 ± 37.3 %; p = 0.001) and increases in CPK and LDH were observed compared to basal values in the O 2 -Suppl (28.4UI/L and 28.3 UI/L). The O 2 -Suppl protocol resulted in a lower increase in CRP (92.1 ± 112.4 % vs. 400.1 ± 384.9 %; p = 0.003). CONCLUSIONS O 2 -Suppl increases exercise-tolerance, resulting in increased muscle injury markers in COPD. However, oxygen supplementation attenuates the inflammatory response, even upon increased physical exercise.",2020,"RESULTS Exercise time was higher with O 2 -Suppl (49.9 ± 37.3%; p = 0.001) and increases in CPK and LDH were observed compared to basal values in the O 2 -Suppl (28.4UI/L and 28.3 UI/L).","['Eleven non-depleted patients with COPD (FEV 1 65.5\u2009±\u20094.3%) performed two EET (room-air or O 2 -Suppl-100', 'COPD patients', 'non-hypoxemic COPD patients']","['oxygen supplementation', 'Oxygen supplementation (O 2 -Suppl', 'O 2 -Suppl during exercise test (EET', 'Oxygen supplementation', 'placebo']","['Exercise time', 'CRP', 'CPK and LDH', 'CPK, LDH and CRP', 'total work and muscle damage markers', 'physical exercise', 'exercise-tolerance', 'CRP level and muscle damage (CPK, LDH, lactate', 'inflammatory response']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C4517759', 'cui_str': '4.3'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C1704407', 'cui_str': '100'}]","[{'cui': 'C0919655', 'cui_str': 'Oxygen supplementation'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0587107', 'cui_str': 'During exercise'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0439587', 'cui_str': 'Exercise time'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0010287', 'cui_str': 'Creatine kinase'}, {'cui': 'C0022917', 'cui_str': 'Lactate dehydrogenase'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0410158', 'cui_str': 'Muscle damage NOS'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0162521', 'cui_str': 'Exercise tolerance'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}]",11.0,0.185322,"RESULTS Exercise time was higher with O 2 -Suppl (49.9 ± 37.3%; p = 0.001) and increases in CPK and LDH were observed compared to basal values in the O 2 -Suppl (28.4UI/L and 28.3 UI/L).","[{'ForeName': 'Daniela Rodrigues', 'Initials': 'DR', 'LastName': 'Andrade', 'Affiliation': 'Laboratory of Exercise Physiology and Cardiac Rehabilitation (GERFE), Department of Medicine and Physiotherapy, Santo Amaro University (UNISA), São Paulo, Brazil.'}, {'ForeName': 'Kelly Critine', 'Initials': 'KC', 'LastName': 'Pinto', 'Affiliation': 'Laboratory of Exercise Physiology and Cardiac Rehabilitation (GERFE), Department of Medicine and Physiotherapy, Santo Amaro University (UNISA), São Paulo, Brazil.'}, {'ForeName': 'Julia Sampel', 'Initials': 'JS', 'LastName': 'de Castro', 'Affiliation': 'Laboratory of Exercise Physiology and Cardiac Rehabilitation (GERFE), Department of Medicine and Physiotherapy, Santo Amaro University (UNISA), São Paulo, Brazil.'}, {'ForeName': 'Daniela Kuguimoto', 'Initials': 'DK', 'LastName': 'Andaku', 'Affiliation': 'Laboratory of Exercise Physiology and Cardiac Rehabilitation (GERFE), Department of Medicine and Physiotherapy, Santo Amaro University (UNISA), São Paulo, Brazil.'}, {'ForeName': 'Viviani Aparecida', 'Initials': 'VA', 'LastName': 'Lara', 'Affiliation': 'Laboratory of Exercise Physiology and Cardiac Rehabilitation (GERFE), Department of Medicine and Physiotherapy, Santo Amaro University (UNISA), São Paulo, Brazil.'}, {'ForeName': 'Fabio Augusto', 'Initials': 'FA', 'LastName': 'de Luca', 'Affiliation': 'Laboratory of Exercise Physiology and Cardiac Rehabilitation (GERFE), Department of Medicine and Physiotherapy, Santo Amaro University (UNISA), São Paulo, Brazil.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Gun', 'Affiliation': 'Laboratory of Exercise Physiology and Cardiac Rehabilitation (GERFE), Department of Medicine and Physiotherapy, Santo Amaro University (UNISA), São Paulo, Brazil.'}, {'ForeName': 'Felipe Augusto Rodrigues', 'Initials': 'FAR', 'LastName': 'Mendes', 'Affiliation': 'Department of Physiotherapy, Ibirapuera University (UNIB), São Paulo, Brazil.'}, {'ForeName': 'Mayron F', 'Initials': 'MF', 'LastName': 'Oliveira', 'Affiliation': 'Pulmonary Function and Clinical Exercise Physiology Unit (SEFICE), Respiratory Division, Department of Medicine, Federal University of São Paulo (UNIFESP), São Paulo, Brazil; VO2Care Research Group, Research Physiotherapy Coordinator of Vila Nova Star Hospital, São Paulo, SP, Brazil.'}, {'ForeName': 'Wladimir Musetti', 'Initials': 'WM', 'LastName': 'Medeiros', 'Affiliation': 'Laboratory of Exercise Physiology and Cardiac Rehabilitation (GERFE), Department of Medicine and Physiotherapy, Santo Amaro University (UNISA), São Paulo, Brazil; Department of Physiotherapy, Ibirapuera University (UNIB), São Paulo, Brazil; Pulmonary Function and Clinical Exercise Physiology Unit (SEFICE), Respiratory Division, Department of Medicine, Federal University of São Paulo (UNIFESP), São Paulo, Brazil; HEART - Institute of Cardiology, Department of Education and Research, São Paulo, Brazil. Electronic address: wmusettimedeiros@hotmail.com.'}]",Respiratory physiology & neurobiology,['10.1016/j.resp.2020.103475'] 1654,32512262,Intensive therapy alleviates subclinical synovitis on ultrasound and disease activity and reduces flare in rheumatoid arthritis patients who have achieved clinical target - a randomized controlled trial.,"OBJECTIVE Whether intensive therapy can alleviate subclinical synovitis and reduce flare in rheumatoid arthritis (RA) patients in clinical remission remains unclear. We designed a 1-year open-labelled, randomized controlled clinical trial to elucidate this question. METHODS RA patients in clinical remission/low disease activity (defined by DAS28-CRP≤ 3.2), however with subclinical synovitis on ultrasound [power Doppler (PD)≥1 and/or gray scale (GS)≥2] were randomized to receive maintenance or intensive treatment at a ratio of 1:1. The primary outcome was the rate of RA relapse (defined by DAS28-CRP>3.2 and an increase≥0.6). The secondary outcomes were changes of PD and GS scores, and clinical disease activity at each visit from baseline. RESULTS 108 patients with 54 in each group were enrolled. During 1-year follow-up, the relapse rate was significantly higher in maintenance group than in intensive group, regardless of all enrolled patients or those in remission [24.1% (13/54) vs. 9.1% (5/54), p=0.039; 26.2% (11/42) vs. 5.3% (2/38), p=0.026, respectively]. Although GS and PD scores were decreased at 12 months in both groups, the decline was more remarkable in intensive group than in maintenance group. The improvement of clinical disease activity score was only observed in intensive group, not maintenance group. Adverse events were comparable between two groups. Abnormal liver function tests were observed in 24 (22%) patients with 16 from intensive group. CONCLUSION Intensive therapy can alleviate subclinical synovitis on ultrasound and clinical disease activity, and prevent relapse in RA patients who have achieved clinical remission or low disease activity, with comparable safety profiles to maintenance therapy. REGISTRATION NUMBER ChiCTR2000029279.",2020,"During 1-year follow-up, the relapse rate was significantly higher in maintenance group than in intensive group, regardless of all enrolled patients or those in remission [24.1% (13/54) vs. 9.1% (5/54), p=0.039; 26.2% (11/42) vs. 5.3% (2/38), p=0.026, respectively].","['rheumatoid arthritis patients who have achieved clinical target ', '24 (22%) patients with 16 from intensive group', 'RA patients in clinical remission/low disease activity (defined by DAS28-CRP≤ 3.2), however with subclinical synovitis on ultrasound [power Doppler (PD)≥1 and/or gray scale (GS)≥2', '108 patients with 54 in each group were enrolled', 'rheumatoid arthritis']","['Intensive therapy', 'intensive therapy']","['rate of RA relapse', 'Adverse events', 'changes of PD and GS scores, and clinical disease activity', 'GS and PD scores', 'relapse rate', 'clinical disease activity score', 'Abnormal liver function tests']","[{'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C4517687', 'cui_str': '3.2'}, {'cui': 'C0205211', 'cui_str': 'Subclinical'}, {'cui': 'C0039103', 'cui_str': 'Synovitis'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0554756', 'cui_str': 'Doppler studies'}, {'cui': 'C0556636', 'cui_str': 'Gy'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C4517530', 'cui_str': '108'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0554756', 'cui_str': 'Doppler studies'}, {'cui': 'C0556636', 'cui_str': 'Gy'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C4706353', 'cui_str': 'DAS - Disease Activity Score'}, {'cui': 'C0151766', 'cui_str': 'Liver function tests abnormal'}]",108.0,0.101084,"During 1-year follow-up, the relapse rate was significantly higher in maintenance group than in intensive group, regardless of all enrolled patients or those in remission [24.1% (13/54) vs. 9.1% (5/54), p=0.039; 26.2% (11/42) vs. 5.3% (2/38), p=0.026, respectively].","[{'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Zhao', 'Affiliation': 'Department of Rheumatology and Clinical Immunology, Peking University First Hospital, Beijing, 100034, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Rheumatology and Clinical Immunology, Peking University First Hospital, Beijing, 100034, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Geng', 'Affiliation': 'Department of Rheumatology and Clinical Immunology, Peking University First Hospital, Beijing, 100034, China.'}, {'ForeName': 'Xiaohui', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Department of Rheumatology and Clinical Immunology, Peking University First Hospital, Beijing, 100034, China.'}, {'ForeName': 'Xuerong', 'Initials': 'X', 'LastName': 'Deng', 'Affiliation': 'Department of Rheumatology and Clinical Immunology, Peking University First Hospital, Beijing, 100034, China.'}, {'ForeName': 'Lanlan', 'Initials': 'L', 'LastName': 'Ji', 'Affiliation': 'Department of Rheumatology and Clinical Immunology, Peking University First Hospital, Beijing, 100034, China.'}, {'ForeName': 'Zhibo', 'Initials': 'Z', 'LastName': 'Song', 'Affiliation': 'Department of Rheumatology and Clinical Immunology, Peking University First Hospital, Beijing, 100034, China.'}, {'ForeName': 'Zhuoli', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Department of Rheumatology and Clinical Immunology, Peking University First Hospital, Beijing, 100034, China. Electronic address: zhuoli.zhang@126.com.'}]",Seminars in arthritis and rheumatism,['10.1016/j.semarthrit.2020.05.014'] 1655,32513308,Evaluating the efficacy and safety of human anti-SARS-CoV-2 convalescent plasma in severely ill adults with COVID-19: A structured summary of a study protocol for a randomized controlled trial.,"OBJECTIVES The aim of this study is to evaluate the efficacy and safety of human anti-SARS-CoV-2 convalescent plasma in hospitalized adults with severe SARS-CoV-2 infection. TRIAL DESIGN This is a prospective, single-center, phase 2, randomized, controlled trial that is blinded to participants and clinical outcome assessor. PARTICIPANTS Eligible participants include adults (≥ 18 years) with evidence of SARS-CoV-2 infection by PCR test of nasopharyngeal or oropharyngeal swab within 14 days of randomization, evidence of infiltrates on chest radiography, peripheral capillary oxygen saturation (SpO2) ≤ 94% on room air, and/or need for supplemental oxygen, non-invasive mechanical ventilation, or invasive mechanical ventilation, who are willing and able to provide written informed consent prior to performing study procedures or who have a legally authorized representative available to do so. Exclusion criteria include participation in another clinical trial of anti-viral agent(s)* for coronavirus disease-2019 (COVID-19), receipt of any anti-viral agent(s)* with possible activity against SARS-CoV-2 <24 hours prior to plasma infusion, mechanical ventilation (including extracorporeal membrane oxygenation [ECMO]) for ≥ 5 days, severe multi-organ failure, history of allergic reactions to transfused blood products per NHSN/CDC criteria, known IgA deficiency, and pregnancy. Included participants will be hospitalized at the time of randomization and plasma infusion. *Use of remdesivir as treatment for COVID-19 is permitted. The study will be undertaken at Columbia University Irving Medical Center in New York, USA. INTERVENTION AND COMPARATOR The investigational treatment is anti-SARS-CoV-2 human convalescent plasma. To procure the investigational treatment, volunteers who recovered from COVID-19 will undergo testing to confirm the presence of anti-SARS-CoV-2 antibody to the spike trimer at a 1:400 dilution. Donors will also be screened for transfusion-transmitted infections (e.g. HIV, HBV, HCV, WNV, HTLV-I/II, T. cruzi, ZIKV). If donors have experienced COVID-19 symptoms within 28 days, they will be screened with a nasopharyngeal swab to confirm they are SARS-CoV-2 PCR-negative. Plasma will be collected using standard apheresis technology by the New York Blood Center. Study participants will be randomized in a 2:1 ratio to receive one unit (200 - 250 mL) of anti-SARS-CoV-2 plasma versus one unit (200 - 250 mL) of the earliest available control plasma. The control plasma cannot be tested for presence of anti-SARS-CoV-2 antibody prior to the transfusion, but will be tested for anti- SARS-CoV-2 antibody after the transfusion to allow for a retrospective per-protocol analysis. MAIN OUTCOMES The primary endpoint is time to clinical improvement. This is defined as time from randomization to either discharge from the hospital or improvement by one point on the following seven-point ordinal scale, whichever occurs first. 1. Not hospitalized with resumption of normal activities 2. Not hospitalized, but unable to resume normal activities 3. Hospitalized, not requiring supplemental oxygen 4. Hospitalized, requiring supplemental oxygen 5. Hospitalized, requiring high-flow oxygen therapy or non-invasive mechanical ventilation 6. Hospitalized, requiring ECMO, invasive mechanical ventilation, or both 7. Death This scale, designed to assess clinical status over time, was based on that recommended by the World Health Organization for use in determining efficacy end-points in clinical trials in hospitalized patients with COVID-19. A recent clinical trial evaluating the efficacy and safety of lopinavir- ritonavir for patients hospitalized with severe COVID-19 used a similar ordinal scale, as have recent clinical trials of novel therapeutics for severe influenza, including a post-hoc analysis of a trial evaluating immune plasma. The primary safety endpoints are cumulative incidence of grade 3 and 4 adverse events and cumulative incidence of serious adverse events during the study period. RANDOMIZATION Study participants will be randomized in a 2:1 ratio to receive anti-SARS-CoV-2 plasma versus control plasma using a web-based randomization platform. Treatment assignments will be generated using randomly permuted blocks of different sizes to minimize imbalance while also minimizing predictability. BLINDING (MASKING) The study participants and the clinicians who will evaluate post-treatment outcomes will be blinded to group assignment. The blood bank and the clinical research team will not be blinded to group assignment. NUMBERS TO BE RANDOMIZED (SAMPLE SIZE) We plan to enroll 129 participants, with 86 in the anti-SARS-CoV-2 arm, and 43 in the control arm. Among the participants, we expect ~70% or n = 72 will achieve clinical improvement. This will yield an 80% power for a one-sided Wald test at 0.15 level of significance under the proportional hazards model with a hazard ratio of 1.5. TRIAL STATUS Protocol AAAS9924, Version 17APR2020, 4/17/2020 Start of recruitment: April 20, 2020 Recruitment is ongoing. TRIAL REGISTRATION ClinicalTrials.gov: NCT04359810 Date of trial registration: April 24, 2020 Retrospectively registered FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest of expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.",2020,"The control plasma cannot be tested for presence of anti-SARS-CoV-2 antibody prior to the transfusion, but will be tested for anti- SARS-CoV-2 antibody after the transfusion to allow for a retrospective per-protocol analysis. ","['hospitalized patients with COVID-19', 'patients hospitalized with severe COVID-19 used a similar ordinal scale', 'severely ill adults with COVID-19', 'Hospitalized, requiring high-flow oxygen therapy or non-invasive mechanical ventilation 6', 'enroll 129 participants, with 86 in the anti-SARS-CoV-2 arm, and 43 in the control arm', 'hospitalized adults with severe SARS-CoV-2 infection', 'Eligible participants include adults (≥ 18 years) with evidence of SARS-CoV-2 infection by PCR test of nasopharyngeal or oropharyngeal swab within 14 days of randomization, evidence of infiltrates on chest radiography, peripheral capillary oxygen saturation (SpO2) ≤ 94% on room air, and/or need for supplemental oxygen, non-invasive mechanical ventilation, or invasive mechanical ventilation, who are willing and able to provide written informed consent prior to performing study procedures or who have a legally authorized representative available to do so', 'Columbia University Irving Medical Center in New York, USA']","['lopinavir- ritonavir', 'possible activity against SARS-CoV-2 <24 hours prior to plasma infusion, mechanical ventilation (including extracorporeal membrane oxygenation [ECMO', 'human anti-SARS-CoV-2 convalescent plasma', 'anti-SARS-CoV-2 plasma versus control plasma using a web-based randomization platform', 'anti-SARS-CoV-2 plasma versus one unit']","['efficacy and safety', 'time to clinical improvement', 'Death', 'cumulative incidence of grade 3 and 4 adverse events and cumulative incidence of serious adverse events']","[{'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0439080', 'cui_str': 'Ordinal number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0231218', 'cui_str': 'Malaise'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0184633', 'cui_str': 'Oxygen therapy'}, {'cui': 'C0205303', 'cui_str': 'Non-invasive'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C1520439', 'cui_str': '129 Strain Mouse'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332120', 'cui_str': 'Evidence of'}, {'cui': 'C0032520', 'cui_str': 'Polymerase chain reaction'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0027442', 'cui_str': 'Nasopharyngeal'}, {'cui': 'C0521367', 'cui_str': 'Oropharyngeal structure'}, {'cui': 'C0183753', 'cui_str': 'Swab'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0332448', 'cui_str': 'Infiltration'}, {'cui': 'C0039985', 'cui_str': 'Plain chest X-ray'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0428178', 'cui_str': 'Capillary oxygen saturation measurement'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C1868981', 'cui_str': 'Invasive mechanical ventilation'}, {'cui': 'C0600109', 'cui_str': 'Willing'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0021430', 'cui_str': 'Informed Consent'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0021613', 'cui_str': 'Inspiratory reserve volume'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}]","[{'cui': 'C0939237', 'cui_str': 'lopinavir and ritonavir'}, {'cui': 'C0332149', 'cui_str': 'Possible'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0278347', 'cui_str': 'Transfusion of plasma'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0015357', 'cui_str': 'Extracorporeal membrane oxygenation'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0740326', 'cui_str': 'Convalescent'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0439148', 'cui_str': 'Unit'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.269262,"The control plasma cannot be tested for presence of anti-SARS-CoV-2 antibody prior to the transfusion, but will be tested for anti- SARS-CoV-2 antibody after the transfusion to allow for a retrospective per-protocol analysis. ","[{'ForeName': 'Christina M', 'Initials': 'CM', 'LastName': 'Eckhardt', 'Affiliation': 'Columbia University Medical Center, New York, USA. cme2113@cumc.columbia.edu.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Cummings', 'Affiliation': 'Columbia University Medical Center, New York, USA.'}, {'ForeName': 'Kartik N', 'Initials': 'KN', 'LastName': 'Rajagopalan', 'Affiliation': 'Columbia University Medical Center, New York, USA.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Borden', 'Affiliation': 'Columbia University Medical Center, New York, USA.'}, {'ForeName': 'Zachary C', 'Initials': 'ZC', 'LastName': 'Bitan', 'Affiliation': 'Columbia University Medical Center, New York, USA.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Wolf', 'Affiliation': 'Columbia University Medical Center, New York, USA.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Kantor', 'Affiliation': 'Columbia University Medical Center, New York, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Briese', 'Affiliation': 'Columbia University Medical Center, New York, USA.'}, {'ForeName': 'Benjamin J', 'Initials': 'BJ', 'LastName': 'Meyer', 'Affiliation': 'Columbia University Medical Center, New York, USA.'}, {'ForeName': 'Samuel D', 'Initials': 'SD', 'LastName': 'Jacobson', 'Affiliation': 'Columbia University Medical Center, New York, USA.'}, {'ForeName': 'Dawn', 'Initials': 'D', 'LastName': 'Scotto', 'Affiliation': 'Columbia University Medical Center, New York, USA.'}, {'ForeName': 'Nischay', 'Initials': 'N', 'LastName': 'Mishra', 'Affiliation': 'Columbia University Medical Center, New York, USA.'}, {'ForeName': 'Neena M', 'Initials': 'NM', 'LastName': 'Philip', 'Affiliation': 'Columbia University Medical Center, New York, USA.'}, {'ForeName': 'Brie A', 'Initials': 'BA', 'LastName': 'Stotler', 'Affiliation': 'Columbia University Medical Center, New York, USA.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Schwartz', 'Affiliation': 'Columbia University Medical Center, New York, USA.'}, {'ForeName': 'Beth', 'Initials': 'B', 'LastName': 'Shaz', 'Affiliation': 'Columbia University Medical Center, New York, USA.'}, {'ForeName': 'Steven L', 'Initials': 'SL', 'LastName': 'Spitalnik', 'Affiliation': 'Columbia University Medical Center, New York, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Eisenberger', 'Affiliation': 'Columbia University Medical Center, New York, USA.'}, {'ForeName': 'Eldad A', 'Initials': 'EA', 'LastName': 'Hod', 'Affiliation': 'Columbia University Medical Center, New York, USA.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Justman', 'Affiliation': 'Columbia University Medical Center, New York, USA.'}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Cheung', 'Affiliation': 'Columbia University Medical Center, New York, USA.'}, {'ForeName': 'W Ian', 'Initials': 'WI', 'LastName': 'Lipkin', 'Affiliation': 'Columbia University Medical Center, New York, USA.'}, {'ForeName': 'Max R', 'Initials': 'MR', 'LastName': ""O'Donnell"", 'Affiliation': 'Columbia University Medical Center, New York, USA.'}]",Trials,['10.1186/s13063-020-04422-y'] 1656,32514794,"Glucagon Administration by Nasal and Intramuscular Routes in Adults With Type 1 Diabetes During Insulin-Induced Hypoglycaemia: A Randomised, Open-Label, Crossover Study.","INTRODUCTION Many commercially available glucagon products for treatment of severe hypoglycaemia require cumbersome reconstitution and potentially intimidating injection during an emergency. Nasal glucagon (NG) is a novel drug-device combination product consisting of a single-use dosing device that delivers glucagon dry powder through nasal administration. The present study assessed whether 3 mg NG was non-inferior to 1 mg intramuscular glucagon (IMG) in adults with type 1 diabetes. METHODS This randomised, open-label, two-period, crossover trial was conducted at two clinical sites. Hypoglycaemia (plasma glucose [PG] target of < 3.3 mmol/l (60 mg/dl) was induced by an intravenous insulin infusion. Glucagon preparations were given by study staff. Treatment success was defined as an increase in PG to ≥ 3.9 mmol/l (70 mg/dl) or an increase of ≥ 1.1 mmol/l (20 mg/dl) from the PG nadir within 30 min of receiving glucagon. RESULTS Of the 66 participants included in the primary efficacy analysis who received both NG and IMG, 100% achieved treatment success, thus demonstrating non-inferiority of NG to IMG. All participants achieved treatment success within 25 min with the mean time to treatment success of 11.4 min (NG) and 9.9 min (IMG). No serious adverse events occurred. Forty-eight treatment-emergent adverse events (TEAEs) occurred after NG and 51 after IMG. Most TEAEs were mild and transient. CONCLUSION Nasal glucagon was as efficacious and well tolerated as IMG for the treatment of insulin-induced hypoglycaemia in adults and will be as useful as IMG as a rescue treatment for severe hypoglycaemia. TRIAL REGISTRATION NCT03339453, ClinicalTrials.gov.",2020,All participants achieved treatment success within 25 min with the mean time to treatment success of 11.4 min (NG) and 9.9 min (IMG).,"['adults with type 1 diabetes', 'Adults With Type 1 Diabetes']","['Insulin-Induced Hypoglycaemia', 'Glucagon preparations', 'Glucagon', 'Nasal glucagon', 'intramuscular glucagon (IMG', 'Nasal glucagon (NG']",['Hypoglycaemia (plasma glucose [PG'],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0017687', 'cui_str': 'Glucagon'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0442117', 'cui_str': 'Intramuscular'}]","[{'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma'}]",,0.229767,All participants achieved treatment success within 25 min with the mean time to treatment success of 11.4 min (NG) and 9.9 min (IMG).,"[{'ForeName': 'Jeffrey G', 'Initials': 'JG', 'LastName': 'Suico', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA. suico_jeffrey_gideon@lilly.com.'}, {'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'Hövelmann', 'Affiliation': 'Profil, Neuss, Germany.'}, {'ForeName': 'Shuyu', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Tong', 'Initials': 'T', 'LastName': 'Shen', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Brandon', 'Initials': 'B', 'LastName': 'Bergman', 'Affiliation': 'Eli Lilly and Company, Indianapolis, IN, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Sherr', 'Affiliation': 'Endocrinology, Department of Pediatrics (Endocrinology), Yale School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Zijlstra', 'Affiliation': 'Profil, Neuss, Germany.'}, {'ForeName': 'Brian M', 'Initials': 'BM', 'LastName': 'Frier', 'Affiliation': ""The Queen's Medical Research Institute, University of Edinburgh, Edinburgh, UK.""}, {'ForeName': 'Leona', 'Initials': 'L', 'LastName': 'Plum-Mörschel', 'Affiliation': 'Profil, Mainz, Germany.'}]","Diabetes therapy : research, treatment and education of diabetes and related disorders",['10.1007/s13300-020-00845-7'] 1657,32516483,Cycling-specific isometric resistance training improves peak power output in elite sprint cyclists.,"INTRODUCTION This study aimed to assess the efficacy of a 6-week cycling-specific, isometric resistance training program on peak power output (PPO) in elite cyclists. METHODS Twenty-four elite track sprint cyclists were allocated to EXP (n = 13, PPO, 1537 ± 307 W) and CON (n = 11, PPO, 1541 ± 389 W) groups. All participants completed a 6-week training program; training content was identical except participants in the EXP group replaced their usual compound lower body resistance training exercise with a cycling-specific, isometric resistance training stimulus. Cycling PPO, knee extensor and cycling-specific isometric strength, and measures of muscle architecture were assessed pre- and post-training. RESULTS In EXP, absolute and relative PPO increased (46 ± 62 W and 0.8 ± 0.7 W/kg, P < .05), and the change in relative PPO was different to CON (-0.1 ± 1.0 W/kg, group × time interaction P = .02). The increase in PPO was concurrent with an increase in extrapolated maximal torque in EXP (7.1 ± 6.5 Nm, P = .007), but the effect was not different from the change in CON (2.4 ± 9.7 Nm, group × time P = .14). Cycling-specific isometric strength also increased more in EXP (group × time P = .002). There were no other between-group differences in response to training. CONCLUSION A 6-week novel, cycling-specific isometric resistance training period improved PPO in a group of elite sprint cyclists by 3%-4%. These data support the use of a cycling-specific isometric resistance training stimulus in the preparation programs of world-class cyclists.",2020,Cycling-specific isometric strength also increased more in EXP (group × time p = 0.002).,"['elite cyclists', 'world-class cyclists', 'elite\xa0sprint cyclists', 'Twenty-four elite track sprint cyclists']","['EXP group replaced their usual compound lower body resistance training exercise with a cycling-specific, isometric resistance training stimulus', 'Cycling-specific isometric resistance training', 'EXP', 'CON', 'six-week cycling-specific, isometric resistance training programme']","['Cycling-specific isometric strength', 'change in relative PPO', 'PPO', 'absolute and relative PPO', 'peak power output (PPO', 'Cycling PPO, knee extensor and cycling-specific isometric strength, and measures of muscle architecture', 'extrapolated maximal torque']","[{'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0040594', 'cui_str': 'Track'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0559956', 'cui_str': 'Replacement - action'}, {'cui': 'C0205198', 'cui_str': 'Compound'}, {'cui': 'C1268088', 'cui_str': 'Lower body structure'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0445194', 'cui_str': 'Power output'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0003737', 'cui_str': 'Architecture'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0318082', 'cui_str': 'Ruminococcus torques'}]",,0.0195751,Cycling-specific isometric strength also increased more in EXP (group × time p = 0.002).,"[{'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Kordi', 'Affiliation': 'Department of Sport, Exercise and Rehabilitation, Northumbria University, Newcastle, UK.'}, {'ForeName': 'Jonathan P', 'Initials': 'JP', 'LastName': 'Folland', 'Affiliation': 'School of Sport, Exercise & Health Sciences, Loughborough University, Loughborough, UK.'}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'Goodall', 'Affiliation': 'Department of Sport, Exercise and Rehabilitation, Northumbria University, Newcastle, UK.'}, {'ForeName': 'Campbell', 'Initials': 'C', 'LastName': 'Menzies', 'Affiliation': 'Centre for Sport, Exercise and Life Sciences, Coventry University, Coventry, UK.'}, {'ForeName': 'Tejal Sarika', 'Initials': 'TS', 'LastName': 'Patel', 'Affiliation': 'Department for Health, University of Bath, Bath, UK.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Evans', 'Affiliation': 'The Football Association, London, UK.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Thomas', 'Affiliation': 'Department of Sport, Exercise and Rehabilitation, Northumbria University, Newcastle, UK.'}, {'ForeName': 'Glyn', 'Initials': 'G', 'LastName': 'Howatson', 'Affiliation': 'Department of Sport, Exercise and Rehabilitation, Northumbria University, Newcastle, UK.'}]",Scandinavian journal of medicine & science in sports,['10.1111/sms.13742'] 1658,32525036,"One layer or two: Does it matter when performing a handsewn bowel anastomosis? Invited Commentary on ""Efficacy of single layered intestinal anastomosis over double layered intestinal anastamosis-an open labeled, randomized controlled trial"".",,2020,,[],['single layered intestinal anastomosis'],[],[],"[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0192711', 'cui_str': 'Anastomosis of intestine'}]",[],,0.075286,,"[{'ForeName': 'Glenn K', 'Initials': 'GK', 'LastName': 'Wakam', 'Affiliation': 'Department of Surgery, University of Michigan, Ann Arbor, MI, USA. Electronic address: gwakam@med.umich.edu.'}, {'ForeName': 'Hasan B', 'Initials': 'HB', 'LastName': 'Alam', 'Affiliation': 'Department of Surgery, University of Michigan, Ann Arbor, MI, USA.'}]","International journal of surgery (London, England)",['10.1016/j.ijsu.2020.05.088'] 1659,32525562,Changes of inflammatory cytokines/chemokines during ravidasvir plus ritonavir-boosted danoprevir and ribavirin therapy for patients with genotype 1b hepatitis C infection.,"This study investigated the safety and efficacy of ravidasvir (RDV) plus ritonavir-boosted danoprevir (DNVr) and ribavirin (RBV) regimens for treatment-naïve non-cirrhotic patients with hepatitis C virus (HCV) genotype 1b in mainland China. We also gained insight into HCV-host interactions during anti-HCV treatment. 16 patients with HCV and 10 healthy people enrolled the study. Three of 16 patients received 12-weeks' placebo treatment first and served as the placebo controls. All (n = 16) patients received 12-weeks' RDV plus DNVr and RBV treatment. The adverse effects (AEs), viral loads, alanine transaminase, and aspartate aminotransferase were recorded during study. We also performed multianalyte profiling of 48 cytokines/chemokines in 16 patients with HCV and 10 normal controls. Seventy-five percent patients treated with RDV plus DNVr and RBV experienced AEs. No death, treatment-related serious AEs or AEs leading to discontinuation were reported. The serum HCV-RNA levels remained extremely high in 3 placebo controls after treated with placebo. After RDV plus DNVr and RBV treatment, all patients achieved sustained virologic response (SVR) at posttreatment week 12, but 1 patient experienced viral relapse at SVR 24. The cytokine/chemokine expression pattern was markedly altered in patients with HCV as compared with healthy controls. The interferon-inducible protein-10 (IP-10) decreased after anti-HCV treatment, and dramatically increased in one patient with viral relapse. The regimen of RDV and DNVr plus RBV represents a highly safe and effective treatment option for HCV patients in mainland China. The IP-10 has the potential to be an indicator of innate immune viral recognition.",2020,"The adverse effects (AEs), viral loads, alanine transaminase (ALT) and aspartate aminotransferase (AST) were recorded during study.","['patients with genotype 1 b hepatitis C infection', '16 HCV patients and 10 healthy people enrolled the study', '16 HCV patients and 10 normal controls', 'treatment-naïve non-cirrhotic patients with hepatitis C virus (HCV) genotype 1b in mainland China', 'HCV patients in mainland China']","[""12-weeks' RDV plus DNVr and RBV treatment"", 'ravidasvir (RDV) plus ritonavir-boosted danoprevir (DNVr) and ribavirin (RBV) regimens', 'placebo', 'ravidasvir plus ritonavir-boosted danoprevir and ribavirin therapy', 'RDV and DNVr plus RBV']","['serum HCV-RNA levels', 'cytokine/chemokine expression pattern', 'sustained virologic response (SVR', 'adverse effects (AEs), viral loads, alanine transaminase (ALT) and aspartate aminotransferase (AST', 'viral relapse']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0017431', 'cui_str': 'Genotype'}, {'cui': 'C1609888', 'cui_str': '(E)-1-(2,3,6-trimethylphenyl)buta-1,3-diene'}, {'cui': 'C0019196', 'cui_str': 'Viral hepatitis C'}, {'cui': 'C0079500', 'cui_str': 'Hepacivirus'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439687', 'cui_str': 'Non-cirrhotic'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C4508633', 'cui_str': 'ravidasvir'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C2973564', 'cui_str': 'danoprevir'}, {'cui': 'C0035525', 'cui_str': 'Ribavirin'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0292818', 'cui_str': 'Ritonavir'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0019163', 'cui_str': 'Type B viral hepatitis'}, {'cui': 'C0035691', 'cui_str': 'RNA virus'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0282554', 'cui_str': 'Cytokines, Chemotactic'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C4050171', 'cui_str': 'Sustained Viral Suppression'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}]",75.0,0.0187822,"The adverse effects (AEs), viral loads, alanine transaminase (ALT) and aspartate aminotransferase (AST) were recorded during study.","[{'ForeName': 'Lanlan', 'Initials': 'L', 'LastName': 'Xiao', 'Affiliation': 'Infections Department, State Key Laboratory for Diagnosis and Treatment of Infectious Diseases, National Clinical Research Center for Infectious Diseases, Collaborative Innovation Center for Diagnosis and Treatment of Infectious Diseases, The First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, China.'}, {'ForeName': 'Xiaoxin', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': 'Infections Department, State Key Laboratory for Diagnosis and Treatment of Infectious Diseases, National Clinical Research Center for Infectious Diseases, Collaborative Innovation Center for Diagnosis and Treatment of Infectious Diseases, The First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, China.'}, {'ForeName': 'Fen', 'Initials': 'F', 'LastName': 'Zhang', 'Affiliation': 'Infections Department, State Key Laboratory for Diagnosis and Treatment of Infectious Diseases, National Clinical Research Center for Infectious Diseases, Collaborative Innovation Center for Diagnosis and Treatment of Infectious Diseases, The First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Infections Department, State Key Laboratory for Diagnosis and Treatment of Infectious Diseases, National Clinical Research Center for Infectious Diseases, Collaborative Innovation Center for Diagnosis and Treatment of Infectious Diseases, The First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, China.'}, {'ForeName': 'Xiaowei', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': 'Infections Department, State Key Laboratory for Diagnosis and Treatment of Infectious Diseases, National Clinical Research Center for Infectious Diseases, Collaborative Innovation Center for Diagnosis and Treatment of Infectious Diseases, The First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, China.'}, {'ForeName': 'Lanjuan', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Infections Department, State Key Laboratory for Diagnosis and Treatment of Infectious Diseases, National Clinical Research Center for Infectious Diseases, Collaborative Innovation Center for Diagnosis and Treatment of Infectious Diseases, The First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, China.'}]",Journal of medical virology,['10.1002/jmv.26161'] 1660,32525564,Thromboembolic events after high-intensity training during cisplatin-based chemotherapy for testicular cancer: Case reports and review of the literature.,"The randomized ""Testicular cancer and Aerobic and Strength Training trial"" (TAST-trial) aimed to evaluate the effect of high-intensity interval training (HIIT) on cardiorespiratory fitness during cisplatin-based chemotherapy (CBCT) for testicular cancer (TC). Here, we report on an unexpected high number of thromboembolic (TE) events among patients randomized to the intervention arm, and on a review of the literature on TE events in TC patients undergoing CBCT. Patients aged 18 to 60 years with a diagnosis of metastatic germ cell TC, planned for 3 to 4 CBCT cycles, were randomized to a 9 to 12 weeks exercise intervention, or to a single lifestyle counseling session. The exercise intervention included two weekly HIIT sessions, each with 2 to 4 intervals of 2 to 4 minutes at 85% to 95% of peak heart rate. The study was prematurely discontinued after inclusion of 19 of the planned 94 patients, with nine patients randomized to the intervention arm and 10 to the control arm. Three patients in the intervention arm developed TE complications; two with pulmonary embolism and one with myocardial infarction. All three patients had clinical stage IIA TC. No TE complications were observed among patients in the control arm. Our observations indicate that high-intensity aerobic training during CBCT might increase the risk of TE events in TC patients, leading to premature closure of the TAST-trial.",2020,No TE complications were observed among patients in the control arm.,"['Patients aged 18-60\u2009years with a diagnosis of metastatic germ cell TC, planned for 3-4 CBCT cycles', 'testicular cancer (TC', 'testicular cancer', 'TC patients undergoing CBCT']","['cisplatin-based chemotherapy (CBCT', 'exercise intervention, or to a single lifestyle counseling session', 'high-intensity interval training (HIIT', 'cisplatin-based chemotherapy']","['TE complications', 'risk of TE events', 'thromboembolic (TE) events', 'Thromboembolic events', 'cardiorespiratory fitness']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0017471', 'cui_str': 'Germ cell'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0442757', 'cui_str': '3/4'}, {'cui': 'C0153594', 'cui_str': 'Malignant tumor of testis'}]","[{'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0730543', 'cui_str': 'Lifestyle education'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}]","[{'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0040038', 'cui_str': 'Thromboembolus'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}]",9.0,0.0580454,No TE complications were observed among patients in the control arm.,"[{'ForeName': 'Lene', 'Initials': 'L', 'LastName': 'Thorsen', 'Affiliation': 'National Advisory Unit on Late Effects after Cancer Treatment, Department of Oncology, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Hege S', 'Initials': 'HS', 'LastName': 'Haugnes', 'Affiliation': 'Department of Oncology, University Hospital of North Norway, Tromsø, Norway.'}, {'ForeName': 'Sophie D', 'Initials': 'SD', 'LastName': 'Fosså', 'Affiliation': 'National Advisory Unit on Late Effects after Cancer Treatment, Department of Oncology, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Brydøy', 'Affiliation': 'Department of Oncology and Medical Physics, Haukeland University Hospital, Bergen, Norway.'}, {'ForeName': 'Torgrim', 'Initials': 'T', 'LastName': 'Tandstad', 'Affiliation': 'Clinic of Oncology, St. Olavs Hospital, Trondheim, Norway.'}, {'ForeName': 'Torbjørn', 'Initials': 'T', 'LastName': 'Wisløff', 'Affiliation': 'Institute of Clinical Medicine, University of Tromsø - The Arctic University, Tromsø, Norway.'}, {'ForeName': 'Gunhild M', 'Initials': 'GM', 'LastName': 'Gjerset', 'Affiliation': 'National Advisory Unit on Late Effects after Cancer Treatment, Department of Oncology, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Edvardsen', 'Affiliation': 'Department of Pulmonary Medicine, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Karl-Otto', 'Initials': 'KO', 'LastName': 'Larsen', 'Affiliation': 'Department of Pulmonary Medicine, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Per Morten', 'Initials': 'PM', 'LastName': 'Sandset', 'Affiliation': 'Institute of Clinical Medicine, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Carola E', 'Initials': 'CE', 'LastName': 'Henriksson', 'Affiliation': 'Institute of Clinical Medicine, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Truls', 'Initials': 'T', 'LastName': 'Raastad', 'Affiliation': 'Department of Physical Performance, Norwegian School of Sports Sciences, Oslo, Norway.'}, {'ForeName': 'Helene F S', 'Initials': 'HFS', 'LastName': 'Negaard', 'Affiliation': 'Department of Oncology, Oslo University Hospital, Oslo, Norway.'}]",International journal of cancer,['10.1002/ijc.33151'] 1661,32528650,Study protocol for a randomised controlled trial of haloperidol plus promethazine plus chlorpromazine versus haloperidol plus promethazine for rapid tranquilisation for agitated psychiatric patients in the emergency setting (TREC-Lebanon).,"Background: Agitated and aggressive behaviours are common in the psychiatric setting and rapid tranquilisation is sometimes unavoidable. A survey of Lebanese practice has shown that an intramuscular haloperidol, promethazine and chlorpromazine combination is a preferred form of treatment but there are no randomised trials of this triple therapy. Methods: This is a pragmatic randomised trial. Setting - the psychiatric wards of the Psychiatric Hospital of the Cross, Jal Eddib, Lebanon. Participants - any adult patient in the hospital who displays an aggressive episode for whom rapid tranquilisation is unavoidable, who has not been randomised before, for whom there are no known contraindications. Randomisation - stratified (by ward) randomisation and concealed in closed opaque envelope by independent parties. Procedure - if the clinical situation arises requiring rapid tranquilisation, medical residents overseeing the patient will open a TREC-Lebanon envelope in which will be notification of which group of treatments should be preferred [Haloperidol + Promethazine + Chlorpromazine (HPC) or Haloperidol + Promethazine (HP)], along with forms for primary, secondary and serious adverse effects. Treatment is not given blindly. Outcome - primary outcome is calm or tranquil at 20 minutes post intervention. Secondary outcomes are calm/tranquil at 40, 60 and 120 minutes post intervention, asleep, adverse effects, use of straitjacket and leaving the ward. Follow-up will be up to two weeks post randomisation. Discussion: Findings from this study will compare the HPC versus HP combination used in Lebanon's psychiatry emergency routine practice. Trial registration: ClinicalTrials.gov NCT03639558. Registration date, August 21, 2018.",2019,"Secondary outcomes are calm/tranquil at 40, 60 and 120 minutes post intervention, asleep, adverse effects, use of straitjacket and leaving the ward.","['Participants - any adult patient in the hospital who displays an aggressive episode for whom rapid tranquilisation is unavoidable', 'agitated psychiatric patients in the emergency setting (TREC-Lebanon']","['haloperidol, promethazine and chlorpromazine combination', 'HPC versus HP combination', 'haloperidol plus promethazine plus chlorpromazine', 'haloperidol plus promethazine', 'Haloperidol + Promethazine + Chlorpromazine (HPC) or Haloperidol + Promethazine (HP']","['calm or tranquil at 20 minutes post intervention', 'calm/tranquil at 40, 60 and 120 minutes post intervention, asleep, adverse effects, use of straitjacket and leaving the ward']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0001807', 'cui_str': 'Aggressive behavior'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0748064', 'cui_str': 'Psychiatric in-patient'}, {'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C1515131', 'cui_str': 'T-cell receptor excision circle'}, {'cui': 'C0023190', 'cui_str': 'Lebanon'}]","[{'cui': 'C0018546', 'cui_str': 'Haloperidol'}, {'cui': 'C0033405', 'cui_str': 'Promethazine'}, {'cui': 'C0008286', 'cui_str': 'Chlorpromazine'}, {'cui': 'C0018956', 'cui_str': 'Hematopoietic stem cell'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0150157', 'cui_str': 'Calming'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0424522', 'cui_str': 'Asleep'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C1305702', 'cui_str': 'Ward'}]",,0.351427,"Secondary outcomes are calm/tranquil at 40, 60 and 120 minutes post intervention, asleep, adverse effects, use of straitjacket and leaving the ward.","[{'ForeName': 'Joseph E', 'Initials': 'JE', 'LastName': 'Dib', 'Affiliation': 'Institute of Mental Health, University of Nottingham, Nottingham, Nottinghamshire, NG1 1NU, UK.'}, {'ForeName': 'Clive E', 'Initials': 'CE', 'LastName': 'Adams', 'Affiliation': 'Institution of Mental Health, University of Nottingham, Nottingham, Nottinghamshire, UK.'}, {'ForeName': 'Werner Henry', 'Initials': 'WH', 'LastName': 'Ikdais', 'Affiliation': 'Psychiatric Hospital of the Cross, Deir Salib, Jal l Dib, Lebanon.'}, {'ForeName': 'Elie', 'Initials': 'E', 'LastName': 'Atallah', 'Affiliation': 'Psychiatric Hospital of the Cross, Deir Salib, Jal l Dib, Lebanon.'}, {'ForeName': 'Hiba Edward', 'Initials': 'HE', 'LastName': 'Yaacoub', 'Affiliation': 'Psychiatric Hospital of the Cross, Deir Salib, Jal l Dib, Lebanon.'}, {'ForeName': 'Tony Jean', 'Initials': 'TJ', 'LastName': 'Merheb', 'Affiliation': 'Psychiatric Hospital of the Cross, Deir Salib, Jal l Dib, Lebanon.'}, {'ForeName': 'Francois', 'Initials': 'F', 'LastName': 'Kazour', 'Affiliation': 'Psychiatric Hospital of the Cross, Deir Salib, Jal l Dib, Lebanon.'}, {'ForeName': 'Fouad', 'Initials': 'F', 'LastName': 'Tahan', 'Affiliation': 'Psychiatric Hospital of the Cross, Deir Salib, Jal l Dib, Lebanon.'}, {'ForeName': 'Georges', 'Initials': 'G', 'LastName': 'Haddad', 'Affiliation': 'Psychiatric Hospital of the Cross, Deir Salib, Jal l Dib, Lebanon.'}, {'ForeName': 'Marouan', 'Initials': 'M', 'LastName': 'Zoghbi', 'Affiliation': 'Psychiatric Hospital of the Cross, Deir Salib, Jal l Dib, Lebanon.'}, {'ForeName': 'Jocelyn', 'Initials': 'J', 'LastName': 'Azar', 'Affiliation': 'Psychiatric Hospital of the Cross, Deir Salib, Jal l Dib, Lebanon.'}, {'ForeName': 'Chadia', 'Initials': 'C', 'LastName': 'Haddad', 'Affiliation': 'Psychiatric Hospital of the Cross, Deir Salib, Jal l Dib, Lebanon.'}, {'ForeName': 'Souheil', 'Initials': 'S', 'LastName': 'Hallit', 'Affiliation': 'Faculty of Medicine and Medical Sciences, Holy Spirit University of Kaslik, Beirut, Lebanon.'}]",F1000Research,['10.12688/f1000research.19933.1'] 1662,32499503,Reconsolidation-based treatment for fear of public speaking: a systematic pilot study using propranolol.,"Pharmacological manipulation of memory reconsolidation opens up promising new avenues for anxiety disorder treatment. However, few studies have directly investigated reconsolidation-based approaches in subclinical or clinical populations, leaving optimal means of fear memory reactivation unknown. We conducted a systematic pilot study to assess whether a reconsolidation-based treatment could tackle public speaking anxiety in a subclinical sample (N = 60). As lab studies indicate that the duration of reactivation may be important for inducing reconsolidation, we investigated several speech lengths to help inform further translational efforts. Participants underwent a stress-inducing speech task composed of 3-min preparation, and from 0 to 9 min of public speaking, in 1-min increments. They then received either 40 mg of propranolol (n = 40) or placebo (n = 20), double-blind, allocated 4:2 for each speech duration. Participants performed a second speech 1 week post treatment, and were followed up with questionnaires 1- and 3 months later. Both self-reported speech distress and questionnaire measures of public speaking anxiety showed clear reductions following treatment. However, propranolol did not reliably outperform placebo, regardless of speech duration at treatment. Physiological responses (heart rate and salivary cortisol) to the public speaking task remained stable from treatment to test. These findings highlight the challenges facing the translation of laboratory research on memory reconsolidation into clinical interventions. Lack of explicit controls for factors beyond duration, such as 'prediction error', could explain these null findings, but positive results in clinical interventions are needed to demonstrate that taking such factors into account can deliver the promises of reconsolidation-based therapy.",2020,Physiological responses (heart rate and salivary cortisol) to the public speaking task remained stable from treatment to test.,"['fear of public speaking', 'tackle public speaking anxiety in a subclinical sample (N\u2009=\u200960']","['stress-inducing speech task composed of 3-min preparation, and from 0 to 9\u2009min of public speaking', 'propranolol', 'placebo']",['Physiological responses (heart rate and salivary cortisol'],"[{'cui': 'C0424169', 'cui_str': 'Fear of public speaking'}, {'cui': 'C0234856', 'cui_str': 'Speaking'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0205211', 'cui_str': 'Subclinical'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}]","[{'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0392359', 'cui_str': 'Public Speaking'}, {'cui': 'C0033497', 'cui_str': 'Propranolol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}]",,0.0293513,Physiological responses (heart rate and salivary cortisol) to the public speaking task remained stable from treatment to test.,"[{'ForeName': 'James W B', 'Initials': 'JWB', 'LastName': 'Elsey', 'Affiliation': 'Department of Clinical Psychology, University of Amsterdam, Amsterdam, Netherlands. j.w.b.elsey@uva.nl.'}, {'ForeName': 'Anna I', 'Initials': 'AI', 'LastName': 'Filmer', 'Affiliation': 'Department of Clinical Psychology, University of Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Harriet R', 'Initials': 'HR', 'LastName': 'Galvin', 'Affiliation': 'Department of Clinical Psychology, University of Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Jennifer D', 'Initials': 'JD', 'LastName': 'Kurath', 'Affiliation': 'Department of Clinical Psychology, University of Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Linos', 'Initials': 'L', 'LastName': 'Vossoughi', 'Affiliation': 'Department of Clinical Psychology, University of Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Linnea S', 'Initials': 'LS', 'LastName': 'Thomander', 'Affiliation': 'Department of Clinical Psychology, University of Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Zavodnik', 'Affiliation': 'Department of Clinical Psychology, University of Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Merel', 'Initials': 'M', 'LastName': 'Kindt', 'Affiliation': 'Department of Clinical Psychology, University of Amsterdam, Amsterdam, Netherlands.'}]",Translational psychiatry,['10.1038/s41398-020-0857-z'] 1663,32502882,Continuing versus suspending angiotensin-converting enzyme inhibitors and angiotensin receptor blockers: Impact on adverse outcomes in hospitalized patients with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)--The BRACE CORONA Trial.,"Angiotensin-converting enzyme-2 (ACE2) expression may increase due to upregulation in patients using angiotensin-converting enzyme inhibitors (ACEI) and angiotensin receptor blockers (ARBs). Because renin-angiotensin system blockers increase levels of ACE2, a protein that facilitates coronavirus entry into cells, there is concern that these drugs could increase the risk of developing a severe and fatal form of COVID-19. The impact of discontinuing ACEI and ARBs in patients with COVID-19 remains uncertain. DESIGN: BRACE CORONA is a pragmatic, multicenter, randomized, phase IV, clinical trial that aims to enroll around 500 participants at 34 sites in Brazil. Participants will be identified from an ongoing national registry of suspected and confirmed cases of COVID-19. Eligible patients using renin-angiotensin system blockers (ACEI/ARBs) with a confirmed diagnosis of COVID-19 will be randomized to a strategy of continued ACEI/ARB treatment versus temporary discontinuation for 30 days. The primary outcome is the median days alive and out of the hospital at 30 days. Secondary outcomes include progression of COVID-19 disease, all-cause mortality, death from cardiovascular causes, myocardial infarction, stroke, transient ischemic attack, new or worsening heart failure, myocarditis, pericarditis, arrhythmias, thromboembolic events, hypertensive crisis, respiratory failure, hemodynamic decompensation, sepsis, renal failure, and troponin, B-type natriuretic peptide (BNP), N-terminal-proBNP, and D-dimer levels. SUMMARY: BRACE CORONA will evaluate whether the strategy of continued ACEI/ARB therapy compared with temporary discontinuation of these drugs impacts clinical outcomes among patients with COVID-19.",2020,Angiotensin-converting enzyme-2 (ACE2) expression may increase due to upregulation in patients using angiotensin-converting enzyme inhibitors (ACEI) and angiotensin receptor blockers (ARBs).,"['patients with COVID-19', 'patients using angiotensin-converting enzyme inhibitors (ACEI) and angiotensin receptor blockers (ARBs', '500 participants at 34 sites in Brazil', 'hospitalized patients with severe acute respiratory syndrome coronavirus 2', 'patients with COVID-19 remains uncertain', 'Eligible patients using renin-angiotensin system blockers (ACEI/ARBs) with a confirmed diagnosis of COVID-19']","['suspending angiotensin-converting enzyme inhibitors and angiotensin receptor blockers', 'Angiotensin-converting enzyme-2 (ACE2']","['progression of COVID-19 disease, all-cause mortality, death from cardiovascular causes, myocardial infarction, stroke, transient ischemic attack, new or worsening heart failure, myocarditis, pericarditis, arrhythmias, thromboembolic events, hypertensive crisis, respiratory failure, hemodynamic decompensation, sepsis, renal failure, and troponin, B-type natriuretic peptide (BNP), N-terminal-proBNP, and D-dimer levels', 'median days alive and out of the hospital at 30 days']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0003015', 'cui_str': 'Angiotensin-converting enzyme inhibitor'}, {'cui': 'C0034787', 'cui_str': 'Angiotensin receptor'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0087130', 'cui_str': 'Uncertain'}, {'cui': 'C0035094', 'cui_str': 'Renin'}, {'cui': 'C0003018', 'cui_str': 'Angiotensin'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0038959', 'cui_str': 'Suspending Agents'}, {'cui': 'C0003015', 'cui_str': 'Angiotensin-converting enzyme inhibitor'}, {'cui': 'C0034787', 'cui_str': 'Angiotensin receptor'}, {'cui': 'C0960880', 'cui_str': 'angiotensin converting enzyme 2'}]","[{'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0007787', 'cui_str': 'Transient cerebral ischemia'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0027059', 'cui_str': 'Myocarditis'}, {'cui': 'C0031046', 'cui_str': 'Pericarditis'}, {'cui': 'C0003811', 'cui_str': 'Cardiac arrhythmia'}, {'cui': 'C0040038', 'cui_str': 'Thromboembolus'}, {'cui': 'C0020546', 'cui_str': 'Hypertensive crisis'}, {'cui': 'C1145670', 'cui_str': 'Respiratory failure'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0231187', 'cui_str': 'Decompensation'}, {'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}, {'cui': 'C0035078', 'cui_str': 'Renal insufficiency'}, {'cui': 'C0041199', 'cui_str': 'Troponin'}, {'cui': 'C0054015', 'cui_str': 'Nesiritide'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0060323', 'cui_str': 'D-dimer'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C2584946', 'cui_str': 'Alive'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]",500.0,0.143314,Angiotensin-converting enzyme-2 (ACE2) expression may increase due to upregulation in patients using angiotensin-converting enzyme inhibitors (ACEI) and angiotensin receptor blockers (ARBs).,"[{'ForeName': 'Renato D', 'Initials': 'RD', 'LastName': 'Lopes', 'Affiliation': ""D'Or Institute for Research and Education (IDOR), Rio de Janeiro, Brazil; Duke Clinical Research Institute, Duke University Medical Center, Durham, NC, USA; Brazilian Clinical Research Institute, São Paulo, Brazil; Rede D'Or São Luiz (RDSL), São Paulo, Brazil. Electronic address: renato.lopes@dm.duke.edu.""}, {'ForeName': 'Ariane Vieira Scarlatelli', 'Initials': 'AVS', 'LastName': 'Macedo', 'Affiliation': ""D'Or Institute for Research and Education (IDOR), Rio de Janeiro, Brazil; Rede D'Or São Luiz (RDSL), São Paulo, Brazil; Santa Casa de São Paulo, São Paulo, Brazil.""}, {'ForeName': 'Pedro Gabriel Melo', 'Initials': 'PGM', 'LastName': 'de Barros E Silva', 'Affiliation': 'Brazilian Clinical Research Institute, São Paulo, Brazil.'}, {'ForeName': 'Renata Junqueira', 'Initials': 'RJ', 'LastName': 'Moll-Bernardes', 'Affiliation': ""D'Or Institute for Research and Education (IDOR), Rio de Janeiro, Brazil.""}, {'ForeName': 'Andre', 'Initials': 'A', 'LastName': 'Feldman', 'Affiliation': ""D'Or Institute for Research and Education (IDOR), Rio de Janeiro, Brazil; Rede D'Or São Luiz (RDSL), São Paulo, Brazil.""}, {'ForeName': 'Guilherme', 'Initials': 'G', 'LastName': ""D'Andréa Saba Arruda"", 'Affiliation': ""D'Or Institute for Research and Education (IDOR), Rio de Janeiro, Brazil; Rede D'Or São Luiz (RDSL), São Paulo, Brazil.""}, {'ForeName': 'Andrea Silvestre', 'Initials': 'AS', 'LastName': 'de Souza', 'Affiliation': ""D'Or Institute for Research and Education (IDOR), Rio de Janeiro, Brazil; Evandro Chagas National Institute of Infectious Diseases, Oswaldo Cruz Foundation, Rio de Janeiro, Brazil; Federal University of Rio de Janeiro (UFRJ), Rio de Janeiro, Brazil.""}, {'ForeName': 'Denilson Campos', 'Initials': 'DC', 'LastName': 'de Albuquerque', 'Affiliation': ""D'Or Institute for Research and Education (IDOR), Rio de Janeiro, Brazil; Universidade do Estado do Rio de Janeiro (UERJ), Rio de Janeiro, Brazil.""}, {'ForeName': 'Lilian', 'Initials': 'L', 'LastName': 'Mazza', 'Affiliation': 'Brazilian Clinical Research Institute, São Paulo, Brazil.'}, {'ForeName': 'Mayara Fraga', 'Initials': 'MF', 'LastName': 'Santos', 'Affiliation': ""D'Or Institute for Research and Education (IDOR), Rio de Janeiro, Brazil.""}, {'ForeName': 'Natalia Zerbinatti', 'Initials': 'NZ', 'LastName': 'Salvador', 'Affiliation': ""D'Or Institute for Research and Education (IDOR), Rio de Janeiro, Brazil.""}, {'ForeName': 'C Michael', 'Initials': 'CM', 'LastName': 'Gibson', 'Affiliation': 'Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Christopher B', 'Initials': 'CB', 'LastName': 'Granger', 'Affiliation': 'Duke Clinical Research Institute, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'Alexander', 'Affiliation': 'Duke Clinical Research Institute, Duke University Medical Center, Durham, NC, USA.'}, {'ForeName': 'Olga Ferreira', 'Initials': 'OF', 'LastName': 'de Souza', 'Affiliation': ""D'Or Institute for Research and Education (IDOR), Rio de Janeiro, Brazil; Rede D'Or São Luiz (RDSL), São Paulo, Brazil.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American heart journal,['10.1016/j.ahj.2020.05.002'] 1664,32502908,Effects of 1 mA and 2 mA transcranial direct current stimulation on working memory performance in healthy participants.,"Anodal transcranial current stimulation (tDCS) to the left dorsolateral prefrontal cortex (DLPFC) has been shown to enhance working memory (WM) in neuropsychiatric patients. In healthy populations, however, tDCS obtains inconclusive results, mostly due to heterogeneous study and stimulation protocols. Here, we approached these issues by investigating effects of tDCS intensity on simultaneous WM performance with three cognitive loads by directly comparing findings of two double-blind, cross-over, sham-controlled experiments. TDCS was administrated to the left DLPFC at intensity of 1 mA (Experiment 1) or 2 mA (Experiment 2), while participants completed a verbal n-back paradigm (1-, 2-, 3-back). Analysis showed no overall effects of tDCS on WM, but a significant interaction with cognitive load. The present study suggests that cognitive load rather than tDCS intensity could be a decisive factor for effects on WM. Moreover, it emphasizes the need of thorough investigation on study parameters to develop more efficient stimulation protocols.",2020,"Analysis showed no overall effects of tDCS on WM, but a significant interaction with cognitive load.","['healthy participants', 'neuropsychiatric patients']","['1\xa0mA and 2\xa0mA transcranial direct current stimulation', 'TDCS', 'Anodal transcranial current stimulation (tDCS']",['working memory performance'],"[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C1172076', 'cui_str': '1-(1-phenylethyl)-2-methyleneaziridine'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0442348', 'cui_str': 'Transcranial approach'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}]","[{'cui': 'C0025265', 'cui_str': 'Immediate memory'}]",,0.0450811,"Analysis showed no overall effects of tDCS on WM, but a significant interaction with cognitive load.","[{'ForeName': 'Irina', 'Initials': 'I', 'LastName': 'Papazova', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Hospital, Ludwig Maximilians University, München, Germany. Electronic address: Irina.papazova@med.uni-muenchen.de.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Strube', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Hospital, Ludwig Maximilians University, München, Germany.'}, {'ForeName': 'Aida', 'Initials': 'A', 'LastName': 'Wienert', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Hospital, Ludwig Maximilians University, München, Germany.'}, {'ForeName': 'Bettina', 'Initials': 'B', 'LastName': 'Henning', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Hospital, Ludwig Maximilians University, München, Germany.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Schwippel', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Neurophysiology & Interventional Neuropsychiatry, University of Tübingen, Germany.'}, {'ForeName': 'Andreas J', 'Initials': 'AJ', 'LastName': 'Fallgatter', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Neurophysiology & Interventional Neuropsychiatry, University of Tübingen, Germany.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Padberg', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Hospital, Ludwig Maximilians University, München, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Falkai', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Hospital, Ludwig Maximilians University, München, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Plewnia', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Neurophysiology & Interventional Neuropsychiatry, University of Tübingen, Germany.'}, {'ForeName': 'Alkomiet', 'Initials': 'A', 'LastName': 'Hasan', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Hospital, Ludwig Maximilians University, München, Germany; Department of Psychiatry, Psychotherapy and Psychosomatics, BKH Augsburg, Medical Faculty, University of Augsburg, Germany.'}]",Consciousness and cognition,['10.1016/j.concog.2020.102959'] 1665,32502923,"A phase III, randomized, double-blind, multicenter study to compare the efficacy, safety, pharmacokinetics, and immunogenicity between SB8 (proposed bevacizumab biosimilar) and reference bevacizumab in patients with metastatic or recurrent nonsquamous non-small cell lung cancer.","OBJECTIVES Efficacy, safety, pharmacokinetics (PK), and immunogenicity of the biosimilar candidate SB8 was compared to its reference product bevacizumab (BEV) in patients with metastatic or recurrent nonsquamous non-small cell lung cancer. METHODS Patients were randomized (1:1) in a phase III, double-blind study to receive intravenous SB8 or BEV 15 mg/kg with paclitaxel/carboplatin every 3 weeks for 24 weeks, followed by SB8 or BEV maintenance monotherapy. The primary endpoint was best overall response rate (ORR) by 24 weeks. Secondary endpoints included survival outcomes, safety, PK, and immunogenicity. RESULTS 763 patients (SB8, n = 379; BEV, n = 384) were randomized; baseline characteristics were well balanced. Best ORR in the FAS was 47.6% and 42.8%, and best ORR in the PPS was 50.1% and 44.8% for SB8 and BEV, respectively. The risk ratio of best ORR was 1.11 (90% CI, 0.975-1.269), and the risk difference in best ORR was 5.3% (95% CI, -2.2%-12.9%). Median survival outcomes were comparable between SB8 and BEV: progression-free survival was 8.50 vs 7.90 months, respectively (HR [95% CI], 0.99 [0.83-1.18]; p = 0.9338); overall survival was 14.90 vs 15.80 months, respectively (HR [95% CI], 1.03 [0.83-1.28]; p = 0.7713); and duration of response was 7.70 vs 7.00 months, respectively (HR [95% CI], 1.05 [0.81-1.37]; p = 0.6928). Severity and incidence of treatment-emergent adverse events, PK, and immunogenicity were comparable between SB8 and BEV. CONCLUSION This study demonstrated equivalence between SB8 and BEV in terms of best ORR risk ratio, with comparable safety, PK, and immunogenicity.",2020,"Severity and incidence of treatment-emergent adverse events, PK, and immunogenicity were comparable between SB8 and BEV. ","['763 patients (SB8, n\u2009=\u2009379; BEV, n\u2009=\u2009384', 'Patients', 'patients with metastatic or recurrent nonsquamous non-small cell lung cancer']","['paclitaxel/carboplatin', 'bevacizumab (BEV', 'bevacizumab', 'intravenous SB8 or BEV 15']","['duration of response', 'Efficacy, safety, pharmacokinetics (PK), and immunogenicity', 'risk ratio of best ORR', 'Median survival outcomes', 'safety, PK, and immunogenicity', 'overall response rate (ORR', 'overall survival', 'Severity and incidence of treatment-emergent adverse events, PK, and immunogenicity', 'FAS', 'efficacy, safety, pharmacokinetics, and immunogenicity', 'SB8 and BEV: progression-free survival', 'survival outcomes, safety, PK, and immunogenicity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}]","[{'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}]","[{'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",763.0,0.560036,"Severity and incidence of treatment-emergent adverse events, PK, and immunogenicity were comparable between SB8 and BEV. ","[{'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Reck', 'Affiliation': 'Department of Thoracic Oncology, Lung Clinic Grosshansdorf, Airway Research Center North, German Center of Lung Research, Lung Clinic, Woehrendamm 80, 22927 Grosshansdorf, Germany. Electronic address: m.reck@lungenclinic.de.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Luft', 'Affiliation': 'Department of Thoracic Surgery, Leningrad Regional Clinical Hospital, St. Petersburg, Russian Federation. Electronic address: alexander_luft@mail.ru.'}, {'ForeName': 'Igor', 'Initials': 'I', 'LastName': 'Bondarenko', 'Affiliation': 'Oncology and Medical Radiology Department, Dnipropetrovsk Medical Academy, Dnipro, Ukraine. Electronic address: oncology@dsma.dp.ua.'}, {'ForeName': 'Serhii', 'Initials': 'S', 'LastName': 'Shevnia', 'Affiliation': 'Department of Chemotherapy, Podillia Regional Oncology Center, Vinnytsia, Ukraine. Electronic address: shevnia1969@gmail.com.'}, {'ForeName': 'Dmytro', 'Initials': 'D', 'LastName': 'Trukhin', 'Affiliation': 'Oncology Department, Odessa Regional Oncology Center, Odessa, Ukraine. Electronic address: dtrukhin39@gmail.com.'}, {'ForeName': 'Nadezhda V', 'Initials': 'NV', 'LastName': 'Kovalenko', 'Affiliation': 'Oncology, Volgograd Regional Clinical Oncology Dispensary, Volgograd, Russian Federation. Electronic address: kovalenkost@yandex.ru.'}, {'ForeName': 'Kakha', 'Initials': 'K', 'LastName': 'Vacharadze', 'Affiliation': 'Department of Phthisiatry, Research Institute of Clinical Medicine, Tbilisi, Georgia. Electronic address: kakhavacharadze@yahoo.com.'}, {'ForeName': 'Fülöp', 'Initials': 'F', 'LastName': 'Andrea', 'Affiliation': 'Department of Pulmonary Class and Bronchology, Országos Korányi TBC és Pulmonológiai Intézet, Budapest, Hungary. Electronic address: afulop64@gmail.com.'}, {'ForeName': 'Anatoliy', 'Initials': 'A', 'LastName': 'Hontsa', 'Affiliation': 'Day Staing Department, Chernivtsi Regional Oncology Center, Chernivtsi, Ukraine. Electronic address: anatoliyhontsa@gmail.com.'}, {'ForeName': 'Jihye', 'Initials': 'J', 'LastName': 'Choi', 'Affiliation': 'Biometrics, Samsung Bioepis Co., Ltd., Suwon, Republic of Korea. Electronic address: jihye24.choi@samsung.com.'}, {'ForeName': 'Donghoon', 'Initials': 'D', 'LastName': 'Shin', 'Affiliation': 'Clinical Development, Samsung Bioepis Co., Ltd., Suwon, Republic of Korea. Electronic address: dh01.shin@samsung.com.'}]","Lung cancer (Amsterdam, Netherlands)",['10.1016/j.lungcan.2020.05.027'] 1666,31100038,Nivolumab Alone and With Ipilimumab in Previously Treated Metastatic Urothelial Carcinoma: CheckMate 032 Nivolumab 1 mg/kg Plus Ipilimumab 3 mg/kg Expansion Cohort Results.,"PURPOSE CheckMate 032 is an open-label, multicohort study that includes patients with unresectable locally advanced or metastatic urothelial carcinoma (mUC) treated with nivolumab 3 mg/kg monotherapy every 2 weeks (NIVO3), nivolumab 3 mg/kg plus ipilimumab 1 mg/kg every 3 weeks for four doses followed by nivolumab monotherapy 3 mg/kg every 2 weeks (NIVO3+IPI1), or nivolumab 1 mg/kg plus ipilimumab 3 mg/kg every 3 weeks for four doses followed by nivolumab monotherapy 3 mg/kg every 2 weeks (NIVO1+IPI3). We report on the expanded NIVO1+IPI3 cohort and extended follow-up for the NIVO3 and NIVO3+IPI1 cohorts. METHODS Patients with platinum-pretreated mUC were enrolled in this phase I/II multicenter study to receive NIVO3, NIVO3+IPI1, or NIVO1+IPI3 until disease progression or unacceptable toxicity. Primary end point was investigator-assessed objective response rate per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, including duration of response. RESULTS Seventy-eight patients were treated with NIVO3 (minimum follow-up, 37.7 months), 104 with NIVO3+IPI1 (minimum follow-up, 38.8 months), and 92 with NIVO1+IPI3 (minimum follow-up, 7.9 months). Objective response rate was 25.6%, 26.9%, and 38.0% in the NIVO3, NIVO3+IPI1, and NIVO1+IPI3 arms, respectively. Median duration of response was more than 22 months in all arms. Grade 3 or 4 treatment-related adverse events occurred in 21 (26.9%), 32 (30.8%), and 36 (39.1%) patients treated with NIVO3, NIVO3+IPI1, and NIVO1+IPI3, respectively. Grade 5 treatment-related pneumonitis occurred in one patient each in the NIVO3 and NIVO3+IPI1 arms. CONCLUSION With longer follow-up, NIVO3 demonstrated sustained antitumor activity alone and in combination with ipilimumab. NIVO1+IPI3 provided the greatest antitumor activity of all regimens, with a manageable safety profile. This result not only supports additional study of NIVO1+IPI3 in mUC, but demonstrates the potential benefit of immunotherapy combinations in this disease.",2019,"Grade 5 treatment-related pneumonitis occurred in one patient each in the NIVO3 and NIVO3+IPI1 arms. ","['Patients with platinum-pretreated mUC', 'CheckMate 032', 'Seventy-eight patients were treated with NIVO3 (minimum follow-up, 37.7 months), 104 with NIVO3+IPI1 (minimum follow-up, 38.8 months), and 92 with NIVO1+IPI3 (minimum follow-up, 7.9 months', 'Previously Treated Metastatic Urothelial Carcinoma', 'patients with unresectable locally advanced or metastatic urothelial carcinoma (mUC) treated with']","['Nivolumab 1 mg/kg Plus Ipilimumab', 'nivolumab 3 mg/kg monotherapy every 2 weeks (NIVO3), nivolumab 3 mg/kg plus ipilimumab', 'Nivolumab Alone and With Ipilimumab', 'nivolumab monotherapy 3 mg/kg every 2 weeks (NIVO3+IPI1), or nivolumab 1 mg/kg plus ipilimumab', 'NIVO3, NIVO3+IPI1, or NIVO1+IPI3 until disease progression or unacceptable toxicity']","['investigator-assessed objective response rate per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, including duration of response', 'Median duration of response', 'antitumor activity', 'Grade 5 treatment-related pneumonitis', 'adverse events', 'Objective response rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032207', 'cui_str': 'Platinum'}, {'cui': 'C4288754', 'cui_str': 'Metastatic urothelial carcinoma'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0585332', 'cui_str': 'Biweekly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}]","[{'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1367202', 'cui_str': 'ipilimumab'}, {'cui': 'C0585332', 'cui_str': 'Biweekly'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0040539', 'cui_str': 'TO'}]","[{'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C1709926', 'cui_str': 'RECIST'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C4517491', 'cui_str': '1.1'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C1705232', 'cui_str': 'Common terminology criteria for adverse events grade 5'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C3714636', 'cui_str': 'Pneumonitis'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",78.0,0.0471775,"Grade 5 treatment-related pneumonitis occurred in one patient each in the NIVO3 and NIVO3+IPI1 arms. ","[{'ForeName': 'Padmanee', 'Initials': 'P', 'LastName': 'Sharma', 'Affiliation': '1 The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Arlene', 'Initials': 'A', 'LastName': 'Siefker-Radtke', 'Affiliation': '1 The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Filippo', 'Initials': 'F', 'LastName': 'de Braud', 'Affiliation': '2 Istituto Nazionale dei Tumori, Milan, Italy.'}, {'ForeName': 'Umberto', 'Initials': 'U', 'LastName': 'Basso', 'Affiliation': '3 Istituto Oncologico Veneto-Istituto di Ricovero e Cura a Carattere Scientifico, Padua, Italy.'}, {'ForeName': 'Emiliano', 'Initials': 'E', 'LastName': 'Calvo', 'Affiliation': '4 START Madrid-Centro Integral Oncológico Clara Campal, Madrid, Spain.'}, {'ForeName': 'Petri', 'Initials': 'P', 'LastName': 'Bono', 'Affiliation': '5 Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Morse', 'Affiliation': '7 Duke University Medical Center, Durham, NC.'}, {'ForeName': 'Paolo A', 'Initials': 'PA', 'LastName': 'Ascierto', 'Affiliation': '8 Istituto Nazionale Tumori-Istituto di Ricovero e Cura a Carattere Scientifico, Fondazione G. Pascale, Naples, Italy.'}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Lopez-Martin', 'Affiliation': '9 Hospital Universitario 12 de Octubre, Madrid, Spain.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Brossart', 'Affiliation': '10 University Hospital of Bonn, Bonn, Germany.'}, {'ForeName': 'Kristoffer', 'Initials': 'K', 'LastName': 'Rohrberg', 'Affiliation': '11 Rigshospitalet, University Hospital of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Begoña', 'Initials': 'B', 'LastName': 'Mellado', 'Affiliation': ""12 Hospital Clinic of Barcelona, Institut D'Investigacions Biomèdiques August Pi i Sunyer, Barcelona, Spain.""}, {'ForeName': 'Bruce S', 'Initials': 'BS', 'LastName': 'Fischer', 'Affiliation': '13 Bristol-Myers Squibb, Princeton, NJ.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Meadows-Shropshire', 'Affiliation': '13 Bristol-Myers Squibb, Princeton, NJ.'}, {'ForeName': '', 'Initials': '', 'LastName': 'Abdel Saci', 'Affiliation': '13 Bristol-Myers Squibb, Princeton, NJ.'}, {'ForeName': 'Margaret K', 'Initials': 'MK', 'LastName': 'Callahan', 'Affiliation': '14 Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Rosenberg', 'Affiliation': '14 Memorial Sloan Kettering Cancer Center, New York, NY.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.00538'] 1667,32506663,Novel delivery of cellular therapy to reduce ischemia reperfusion injury in kidney transplantation.,"Ex vivo normothermic machine perfusion (NMP) of donor kidneys prior to transplantation provides a platform for direct delivery of cellular therapeutics to optimize organ quality prior to transplantation. Multipotent Adult Progenitor Cells (MAPC ® ) possess potent immunomodulatory properties that could minimize ischemia reperfusion injury. We investigated the potential capability of MAPC cells in kidney NMP. Pairs (5) of human kidneys, from the same donor, were simultaneously perfused for 7 hours. Kidneys were randomly allocated to receive MAPC treatment or control. Serial samples of perfusate, urine, and tissue biopsies were taken for comparison. MAPC-treated kidneys demonstrated improved urine output (P = .009), decreased expression of injury biomarker NGAL (P = .012), improved microvascular perfusion on contrast-enhanced ultrasound (cortex P = .019, medulla P = .001), downregulation of interleukin (IL)-1β (P = .050), and upregulation of IL-10 (P < .047) and Indolamine-2, 3-dioxygenase (P = .050). A chemotaxis model demonstrated decreased neutrophil recruitment when stimulated with perfusate from MAPC-treated kidneys (P < .001). Immunofluorescence revealed prelabeled MAPC cells in the perivascular space of kidneys during NMP. We report the first successful delivery of cellular therapy to a human kidney during NMP. Kidneys treated with MAPC cells demonstrate improvement in clinically relevant parameters and injury biomarkers. This novel method of cell therapy delivery provides an exciting opportunity to recondition organs prior to transplantation.",2020,"MAPC-treated kidneys demonstrated improved urine-output (p=0.009), decreased expression of injury biomarker NGAL (p=0.012), improved microvascular perfusion on contrast enhanced ultrasound (cortex p=0.019, medulla p=0.001), downregulation of IL-1β (p=0.050) and upregulation of IL-10 (p<0.047) and Indolamine-2, 3-dioxygenase (p=0.050).","['kidney transplantation', 'human kidney during NMP', 'kidney NMP']","['MAPC treatment or control', 'cellular therapy', 'MAPC cells', 'Ex-vivo normothermic machine perfusion (NMP', 'Multipotent Adult Progenitor Cells (MAPC ® ']","['Immunofluorescence revealed pre-labelled MAPC cells', 'urine-output', 'neutrophil recruitment', 'expression of injury biomarker NGAL', 'microvascular perfusion', 'downregulation of IL-1β (p=0.050) and upregulation of IL-10']","[{'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0445103', 'cui_str': 'Normothermia'}, {'cui': 'C0336779', 'cui_str': 'Machine'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0302189', 'cui_str': 'Therapy, Cell'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0445103', 'cui_str': 'Normothermia'}, {'cui': 'C0336779', 'cui_str': 'Machine'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0038250', 'cui_str': 'Stem cell'}]","[{'cui': 'C0016318', 'cui_str': 'Fluorescent identification of anti-nuclear antibody'}, {'cui': 'C0443289', 'cui_str': 'Revealed'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0232856', 'cui_str': 'Rate of urine output, function'}, {'cui': 'C0751982', 'cui_str': 'Neutrophil Recruitment'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0215955', 'cui_str': 'LCN2 protein, human'}, {'cui': 'C0443258', 'cui_str': 'Microvascular'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0013081', 'cui_str': 'Down-regulation'}, {'cui': 'C0041904', 'cui_str': 'Up-Regulation (Physiology)'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}]",,0.0198533,"MAPC-treated kidneys demonstrated improved urine-output (p=0.009), decreased expression of injury biomarker NGAL (p=0.012), improved microvascular perfusion on contrast enhanced ultrasound (cortex p=0.019, medulla p=0.001), downregulation of IL-1β (p=0.050) and upregulation of IL-10 (p<0.047) and Indolamine-2, 3-dioxygenase (p=0.050).","[{'ForeName': 'Emily R', 'Initials': 'ER', 'LastName': 'Thompson', 'Affiliation': 'NIHR Blood and Transplant Research Unit in Organ Donation and Transplantation, Institute of Transplantation, Freeman Hospital, Newcastle upon Tyne, UK.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Bates', 'Affiliation': 'NIHR Blood and Transplant Research Unit in Organ Donation and Transplantation, Institute of Transplantation, Freeman Hospital, Newcastle upon Tyne, UK.'}, {'ForeName': 'Ibrahim K', 'Initials': 'IK', 'LastName': 'Ibrahim', 'Affiliation': 'NIHR Blood and Transplant Research Unit in Organ Donation and Transplantation, Institute of Transplantation, Freeman Hospital, Newcastle upon Tyne, UK.'}, {'ForeName': 'Avinash', 'Initials': 'A', 'LastName': 'Sewpaul', 'Affiliation': 'NIHR Blood and Transplant Research Unit in Organ Donation and Transplantation, Institute of Transplantation, Freeman Hospital, Newcastle upon Tyne, UK.'}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Stenberg', 'Affiliation': 'Department of Radiology, Freeman Hospital, Newcastle upon Tyne, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'McNeill', 'Affiliation': 'Department of Radiology, Freeman Hospital, Newcastle upon Tyne, UK.'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Figueiredo', 'Affiliation': 'NIHR Blood and Transplant Research Unit in Organ Donation and Transplantation, Institute of Transplantation, Freeman Hospital, Newcastle upon Tyne, UK.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Girdlestone', 'Affiliation': 'NIHR Blood and Transplant Research Unit in Organ Donation and Transplantation, Institute of Transplantation, Freeman Hospital, Newcastle upon Tyne, UK.'}, {'ForeName': 'Georgina C', 'Initials': 'GC', 'LastName': 'Wilkins', 'Affiliation': 'NIHR Blood and Transplant Research Unit in Organ Donation and Transplantation, Institute of Transplantation, Freeman Hospital, Newcastle upon Tyne, UK.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'NIHR Blood and Transplant Research Unit in Organ Donation and Transplantation, Institute of Transplantation, Freeman Hospital, Newcastle upon Tyne, UK.'}, {'ForeName': 'Samuel J', 'Initials': 'SJ', 'LastName': 'Tingle', 'Affiliation': 'NIHR Blood and Transplant Research Unit in Organ Donation and Transplantation, Institute of Transplantation, Freeman Hospital, Newcastle upon Tyne, UK.'}, {'ForeName': 'William E', 'Initials': 'WE', 'LastName': 'Scott', 'Affiliation': 'NIHR Blood and Transplant Research Unit in Organ Donation and Transplantation, Institute of Transplantation, Freeman Hospital, Newcastle upon Tyne, UK.'}, {'ForeName': 'Henrique', 'Initials': 'H', 'LastName': 'de Paula Lemos', 'Affiliation': 'Translational and Clinical Research Institute, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Andrew L', 'Initials': 'AL', 'LastName': 'Mellor', 'Affiliation': 'Translational and Clinical Research Institute, Newcastle University, Newcastle upon Tyne, UK.'}, {'ForeName': 'Valerie D', 'Initials': 'VD', 'LastName': 'Roobrouck', 'Affiliation': 'ReGenesys, Leuven, Belgium.'}, {'ForeName': 'Anthony E', 'Initials': 'AE', 'LastName': 'Ting', 'Affiliation': 'Athersys Inc., Cleveland, OH, USA.'}, {'ForeName': 'Sarah A', 'Initials': 'SA', 'LastName': 'Hosgood', 'Affiliation': ""NIHR Blood and Transplant Research Unit, Department of Surgery, Addenbrooke's Hospital, University of Cambridge, Cambridge, UK.""}, {'ForeName': 'Michael L', 'Initials': 'ML', 'LastName': 'Nicholson', 'Affiliation': ""NIHR Blood and Transplant Research Unit, Department of Surgery, Addenbrooke's Hospital, University of Cambridge, Cambridge, UK.""}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Fisher', 'Affiliation': 'NIHR Blood and Transplant Research Unit in Organ Donation and Transplantation, Institute of Transplantation, Freeman Hospital, Newcastle upon Tyne, UK.'}, {'ForeName': 'Simi', 'Initials': 'S', 'LastName': 'Ali', 'Affiliation': 'NIHR Blood and Transplant Research Unit in Organ Donation and Transplantation, Institute of Transplantation, Freeman Hospital, Newcastle upon Tyne, UK.'}, {'ForeName': 'Neil S', 'Initials': 'NS', 'LastName': 'Sheerin', 'Affiliation': 'NIHR Blood and Transplant Research Unit in Organ Donation and Transplantation, Institute of Transplantation, Freeman Hospital, Newcastle upon Tyne, UK.'}, {'ForeName': 'Colin H', 'Initials': 'CH', 'LastName': 'Wilson', 'Affiliation': 'NIHR Blood and Transplant Research Unit in Organ Donation and Transplantation, Institute of Transplantation, Freeman Hospital, Newcastle upon Tyne, UK.'}]",American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons,['10.1111/ajt.16100'] 1668,32507863,Moxifloxacin versus amoxicillin plus metronidazole as adjunctive therapy for generalized aggressive periodontitis: a pilot randomized controlled clinical trial.,"OBJECTIVE Adjunctive antimicrobials improve probing depth and clinical attachment loss compared with subgingival debridement (SD) alone in patients with aggressive periodontitis. The microbiologic and clinical effectiveness of moxifloxacin (MOX) and amoxicillin plus metronidazole (AMOX+ME) as adjunctive therapies for generalized aggressive periodontitis were compared. METHOD AND MATERIALS This pilot randomized controlled clinical trial included 36 patients who were assigned to one of three therapy groups: SD plus systemic MOX (400 mg QD for 7 days), SD plus systemic AMOX+ME (500 mg TID each for 7 days), or SD plus placebo. Probing depth, clinical attachment loss, bleeding on probing, and plaque were recorded at baseline and 3 and 6 months after treatment. Subgingival plaque samples were analyzed. RESULTS All treatments resulted in significant probing depth and clinical attachment loss reduction compared with the baseline values (P < .0001 for all), with the effects still present at 6 months posttreatment, but the patients taking antibiotic protocols presented the most significant gains (P < .0001). There was a significant reduction in the occurrence of gingival pockets ≥ 6 mm at 6 months in all treatment groups (P < .0001), favoring the MOX and AMOX+ME groups. Adjunctive MOX diminished subgingival Aggregatibacter actinomycetemcomitans to unnoticeable stages, after the follow-up period. Adverse events were noted only in some patients of the AMOX+ME group. CONCLUSIONS This pilot clinical trial proposes that using MOX and AMOX+ME as adjuncts to SD improves the clinical and microbiologic parameters in comparison to mechanical therapy alone; however, the MOX protocol did not cause adverse events and decreased subgingival A actinomycetemcomitans to imperceptible levels.",2020,"All treatments resulted in significant probing depth and clinical attachment loss reduction compared with the baseline values (P < .0001 for all), with the effects still present at 6 months posttreatment, but the patients taking antibiotic protocols presented the most significant gains (P < .0001).","['generalized aggressive periodontitis', '36 patients who were assigned to one of three therapy groups', 'patients with aggressive periodontitis']","['SD plus systemic AMOX+ME', 'subgingival debridement (SD) alone', 'AMOX+ME', 'Moxifloxacin', 'MOX and AMOX+ME', 'amoxicillin plus metronidazole', 'SD plus systemic MOX', 'moxifloxacin (MOX) and amoxicillin plus metronidazole (AMOX+ME', 'placebo']","['Adverse events', 'significant probing depth and clinical attachment loss reduction', 'Probing depth, clinical attachment loss, bleeding on probing, and plaque', 'probing depth and clinical attachment loss', 'occurrence of gingival pockets']","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0001342', 'cui_str': 'Acute periodontitis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C1527374', 'cui_str': 'Group Therapy'}]","[{'cui': 'C0595817', 'cui_str': 'Subgingival route'}, {'cui': 'C0011079', 'cui_str': 'Debridement'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0002645', 'cui_str': 'Amoxicillin'}, {'cui': 'C0025872', 'cui_str': 'Metronidazole'}, {'cui': 'C0536495', 'cui_str': 'moxifloxacin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0017571', 'cui_str': 'Gingival pocket'}]",36.0,0.171925,"All treatments resulted in significant probing depth and clinical attachment loss reduction compared with the baseline values (P < .0001 for all), with the effects still present at 6 months posttreatment, but the patients taking antibiotic protocols presented the most significant gains (P < .0001).","[{'ForeName': 'Carlos M', 'Initials': 'CM', 'LastName': 'Ardila', 'Affiliation': ''}, {'ForeName': 'Juliana', 'Initials': 'J', 'LastName': 'Flórez-Flórez', 'Affiliation': ''}, {'ForeName': 'Luis-David', 'Initials': 'LD', 'LastName': 'Castañeda-Parra', 'Affiliation': ''}, {'ForeName': 'Isabel C', 'Initials': 'IC', 'LastName': 'Guzmán', 'Affiliation': ''}, {'ForeName': 'Jader A', 'Initials': 'JA', 'LastName': 'Bedoya-García', 'Affiliation': ''}]","Quintessence international (Berlin, Germany : 1985)",['10.3290/j.qi.a44715'] 1669,32511775,Effects of adjunctive probiotic L. reuteri lozenges on S/RSD outcomes at molar sites with deep pockets.,"AIM To evaluate effects of probiotic Lactobacillus reuteri (L. reuteri) lozenges as an S/RSD adjunct on site-level changes at molars with deep pockets. MATERIALS AND METHODS 447 molar sites with pockets ≥ 5 mm from a previous randomized clinical trial of adjunctive L. reuteri lozenges for 28 days were analyzed. Multilevel mixed-effect models (MLM) were constructed to analyze site-level outcomes ""change in CAL"" and ""pocket closure"" (residual PPD < 5 mm) in placebo and probiotic groups at 90 and 180 days. Possible patient-, tooth-, and site-level predictors were analyzed as fixed-effects. RESULTS Estimated change in CAL in probiotic (90 day: 0.87 mm, 180 day: 0.68 mm) was greater than placebo treated molar sites (90 day: 0.73 mm, 180 day: 0.66 mm) and the relative risk (RR) of pocket closure in the probiotic group (90 day: 1.7, 180 day: 1.6) was higher as compared to placebo. Furcation involvement and BOP at site predicted significantly worse treatment outcomes. CONCLUSION As compared to S/RSD with placebo, a 28-day course of adjunctive probiotic L. reuteri lozenges improved CAL change at molar sites with ≥ 5 mm deep pockets and conferred a higher probability of shallow residual pocket depth. Presence of furcation-involvement and bleeding on probing worsened treatment outcomes.",2020,"Furcation involvement and BOP at site predicted significantly worse treatment outcomes. ","['at molar sites with deep pockets', '447 molar sites with pockets ≥ 5mm from a previous randomized clinical trial of', 'site-level changes at molars with deep pockets']","['adjunctive L. reuteri lozenges', 'probiotic Lactobacillus reuteri (L. reuteri) lozenges', 'adjunctive probiotic L. reuteri lozenges', 'placebo']","['Furcation involvement and BOP', 'CAL change', 'S/RSD outcomes', 'relative risk (RR) of pocket closure']","[{'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0206034', 'cui_str': 'Trials, Randomized Clinical'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]","[{'cui': 'C0317625', 'cui_str': 'Lactobacillus reuteri'}, {'cui': 'C0991564', 'cui_str': 'Lozenge'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0796232', 'cui_str': 'Bohring Opitz syndrome'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0242492', 'cui_str': 'Relative Risk'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}]",,0.290731,"Furcation involvement and BOP at site predicted significantly worse treatment outcomes. ","[{'ForeName': 'Georgios', 'Initials': 'G', 'LastName': 'Pelekos', 'Affiliation': 'Faculty of Dentistry, The University of Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'Aneesha', 'Initials': 'A', 'LastName': 'Acharya', 'Affiliation': 'Faculty of Dentistry, The University of Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'Nemoto', 'Initials': 'N', 'LastName': 'Eiji', 'Affiliation': 'Department of Periodontology and Endodontology, Tohoku University Graduate School of Dentistry, Sendai, Japan.'}, {'ForeName': 'Guang', 'Initials': 'G', 'LastName': 'Hong', 'Affiliation': 'Liaison Center for Innovative Dentistry, Tohoku University Graduate School of Dentistry, Sendai, Japan.'}, {'ForeName': 'Wai Keung', 'Initials': 'WK', 'LastName': 'Leung', 'Affiliation': 'Faculty of Dentistry, The University of Hong Kong, Hong Kong SAR, China.'}, {'ForeName': 'Colman', 'Initials': 'C', 'LastName': 'McGrath', 'Affiliation': 'Faculty of Dentistry, The University of Hong Kong, Hong Kong SAR, China.'}]",Journal of clinical periodontology,['10.1111/jcpe.13329'] 1670,32512513,The effects of repetitive transcranial magnetic stimulation on cue-induced craving in male patients with heroin use disorder.,"BACKGROUND Craving is a central feature of addiction. Early evidence suggests that repetitive transcranial magnetic stimulation is effective in reducing cue induced craving for patients with opioid use disorder (OUD). However, trials in large populations of patients with OUDs are lacking. METHODS We randomly assigned 118 male heroin patients into three groups (i.e., 10 Hz rTMS, 1 Hz rTMS and a wait-list control group) from two addiction rehabilitation centers. rTMS was applied to the left dorsolateral prefrontal cortex (DLPFC) for 20 daily consecutive sessions. FINDINGS Results showed that 10 Hz rTMS and 1 Hz rTMS were both effective in reducing cue-induced craving scores in heroin users when compared to the wait list group. The treatment effects lasted for up to 60 days after rTMS treatment cessation. INTERPRETATION Our results suggest that rTMS applied to the DLPFC is effective in reducing craving severity in heroin use disorder patients. Our results also suggest that such treatment effects can last for up to 60 days after treatment cessation.",2020,"FINDINGS Results showed that 10 Hz rTMS and 1 Hz rTMS were both effective in reducing cue-induced craving scores in heroin users when compared to the wait list group.","['male patients with heroin use disorder', '118 male heroin patients into three groups (i.e., 10', 'heroin use disorder patients', 'patients with opioid use disorder (OUD']","['repetitive transcranial magnetic stimulation', 'rTMS', 'Hz rTMS, 1\u202fHz rTMS and a wait-list control group) from two addiction rehabilitation centers']","['cue-induced craving scores', 'craving severity']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011892', 'cui_str': 'Heroin'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C4517542', 'cui_str': '118'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4324621', 'cui_str': 'Opioid use disorder'}]","[{'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0085281', 'cui_str': 'Addiction'}, {'cui': 'C0034993', 'cui_str': 'Centers, Rehabilitation'}]","[{'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",118.0,0.0241904,"FINDINGS Results showed that 10 Hz rTMS and 1 Hz rTMS were both effective in reducing cue-induced craving scores in heroin users when compared to the wait list group.","[{'ForeName': 'Xiaoli', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Shanghai Key Laboratory of Psychotic Disorders, Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China; School of Psychology, Nanjing Normal University, Nanjing, Jiangsu, China; Co-innovation Center of Neuroregeneration, Nantong University, Nantong, Jiangsu, China; Ningbo Key Laboratory of Sleep Medicine, Ningbo Kangning Hospital, Ningbo, Zhejiang, China.'}, {'ForeName': 'Xiwen', 'Initials': 'X', 'LastName': 'Zhao', 'Affiliation': 'Yale Center for Analytical Sciences, School of Public Health, Yale University, New Haven, CT, U.S.A.'}, {'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Liu', 'Affiliation': 'Shanghai Key Laboratory of Psychotic Disorders, Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China; School of Psychology, Nanjing Normal University, Nanjing, Jiangsu, China.'}, {'ForeName': 'Qingming', 'Initials': 'Q', 'LastName': 'Liu', 'Affiliation': 'Shanghai Key Laboratory of Psychotic Disorders, Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China; School of Psychology, Nanjing Normal University, Nanjing, Jiangsu, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Tang', 'Affiliation': ""Department of Biostatistics, St. Jude Children's Research Hospital, U.S.A.""}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Department of Preventive Medicine, Feinberg School of Medicine, Northwestern University, Chicago, U.S.A.'}, {'ForeName': 'Wenbo', 'Initials': 'W', 'LastName': 'Luo', 'Affiliation': 'Research Center of Brain and Cognitive Neuroscience, Liaoning Normal University, Dalian, China; Key Laboratory of Brain and Cognitive Neurosience, Liaoning Province, China. Electronic address: luowb@lnnu.edu.cn.'}, {'ForeName': 'Zafiris J', 'Initials': 'ZJ', 'LastName': 'Daskalakis', 'Affiliation': 'Temerty Centre for Therapeutic Brain Intervention, Centre for Addiction and Mental Health, University of Toronto, Toronto, Ont., Canada; Department of Psychiatry, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Ti-Fei', 'Initials': 'TF', 'LastName': 'Yuan', 'Affiliation': 'Shanghai Key Laboratory of Psychotic Disorders, Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China; Co-innovation Center of Neuroregeneration, Nantong University, Nantong, Jiangsu, China. Electronic address: ytf0707@126.com.'}]",EBioMedicine,['10.1016/j.ebiom.2020.102809'] 1671,32512517,Association between cellular HIV-1 DNA level and mortality in HIV-1 infected African adults starting ART with high CD4 counts.,"BACKGROUND High HIV-1 DNA levels in peripheral blood mononuclear cells (PBMC) were associated with a higher risk of severe morbidity and a faster decline in CD4 count in ART-naive patients. We report the association between HIV-1 DNA and mortality in HIV-infected adults in a trial of early ART in West Africa. METHODS In the Temprano trial, HIV-infected adults were randomly assigned to start ART immediately or defer ART. After trial termination, HIV-1 DNA was measured in whole blood samples frozen at baseline. We analyzed the association between baseline PBMC HIV-1 DNA and long-term mortality. FINDINGS 2019 patients were followed for 9253 patient-years (median 4.9 years). At baseline, the median CD4 count was 462/mm 3 [IQR 368-571], the median plasma HIV-1 RNA 4.7 log 10 copies/ml [IQR 4.0-5.2], and the median HIV-1 DNA 2.9 log 10 copies/million PBMC [IQR 2.5-3.3]. During follow-up, 86 participants died. In univariate analysis, the hazard ratio [HR] of death was 2.67 (95% CI, 1.68-4.22) for patients with HIV-1 DNA ≥3 log 10 copies/million PBMC vs. others, and 2.10 (95% CI, 1.38-3.21) for patients with HIV-1 RNA ≥5 log10 copies/ml vs. others. In multivariate Cox regression analysis, HIV-1 DNA levels ≥3 log 10 copies/million PBMC were strongly associated mortality (adjusted HR = 2.09, 95% CI 1.24-3.52, p= 0.005) while the association between baseline plasma HIV-1 RNA and mortality was not significant. INTERPRETATION In these African adults who started ART with high CD4 counts, HIV-1 DNA was a strong independent predictor of death. The HIV reservoir still plays a prognostic role in the early ART era. FUNDING This trial was supported by the French National Agency for AIDS and viral hepatitis research (ANRS, Paris, France; Grants ANRS 12136, 12224 and 12253).",2020,"At baseline, the median CD4 count was 462/mm 3 [IQR 368-571], the median plasma HIV-1 RNA 4.7 log 10 copies/ml [IQR 4.0-5.2], and the median HIV-1 DNA 2.9 log 10 copies/million PBMC [IQR 2.5-3.3].","['HIV-infected adults in a trial of early ART in West Africa', '2019 patients were followed for 9253 patient-years (median 4.9 years', 'HIV-infected adults', 'HIV-1 infected African adults starting ART with high CD4 counts']",[],"['median plasma HIV-1 RNA', 'hazard ratio [HR] of death', 'HIV-1 DNA and mortality', 'HIV-1 DNA', 'mortality', 'median CD4 count', 'baseline plasma HIV-1 RNA and mortality', 'CD4 count']","[{'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0001747', 'cui_str': 'Western Africa'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0019704', 'cui_str': 'Human immunodeficiency virus type I'}, {'cui': 'C0027567', 'cui_str': 'African race'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0243009', 'cui_str': 'CD4+ Cell Counts'}]",[],"[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0369499', 'cui_str': 'Human immunodeficiency virus 1 RNA'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0486948', 'cui_str': 'Human immunodeficiency virus 1 DNA'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0243009', 'cui_str': 'CD4+ Cell Counts'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]",2019.0,0.300537,"At baseline, the median CD4 count was 462/mm 3 [IQR 368-571], the median plasma HIV-1 RNA 4.7 log 10 copies/ml [IQR 4.0-5.2], and the median HIV-1 DNA 2.9 log 10 copies/million PBMC [IQR 2.5-3.3].","[{'ForeName': 'Jean Baptiste', 'Initials': 'JB', 'LastName': ""N'takpe"", 'Affiliation': ""Centre Inserm 1219, Institut de Recherche pour le Développement (IRD), University of Bordeaux, 146 rue Léo Saignat, 33076 Bordeaux, France; PACCI/ANRS research site in Côte d'Ivoire, Côte d'Ivoire. Electronic address: jean-baptiste.ntakpe@u-bordeaux.fr.""}, {'ForeName': 'Delphine', 'Initials': 'D', 'LastName': 'Gabillard', 'Affiliation': ""Centre Inserm 1219, Institut de Recherche pour le Développement (IRD), University of Bordeaux, 146 rue Léo Saignat, 33076 Bordeaux, France; PACCI/ANRS research site in Côte d'Ivoire, Côte d'Ivoire.""}, {'ForeName': 'Raoul', 'Initials': 'R', 'LastName': 'Moh', 'Affiliation': ""Centre Inserm 1219, Institut de Recherche pour le Développement (IRD), University of Bordeaux, 146 rue Léo Saignat, 33076 Bordeaux, France; PACCI/ANRS research site in Côte d'Ivoire, Côte d'Ivoire; Département de Dermatologie et Maladies Infectieuses, Université Felix Houphouët Boigny, Abidjan, Côte d'Ivoire.""}, {'ForeName': 'Elise', 'Initials': 'E', 'LastName': 'Gardiennet', 'Affiliation': 'AP-HP, CHU Necker Enfants Malades, EA 7327 Université Paris Descartes, Paris, France.'}, {'ForeName': 'Arlette', 'Initials': 'A', 'LastName': 'Emieme', 'Affiliation': ""Centre Inserm 1219, Institut de Recherche pour le Développement (IRD), University of Bordeaux, 146 rue Léo Saignat, 33076 Bordeaux, France; PACCI/ANRS research site in Côte d'Ivoire, Côte d'Ivoire; CeDReS, CHU de Treichville, Abidjan, Côte d'Ivoire.""}, {'ForeName': 'Anani', 'Initials': 'A', 'LastName': 'Badje', 'Affiliation': ""Centre Inserm 1219, Institut de Recherche pour le Développement (IRD), University of Bordeaux, 146 rue Léo Saignat, 33076 Bordeaux, France; PACCI/ANRS research site in Côte d'Ivoire, Côte d'Ivoire.""}, {'ForeName': 'Gérard M', 'Initials': 'GM', 'LastName': 'Kouame', 'Affiliation': ""Centre Inserm 1219, Institut de Recherche pour le Développement (IRD), University of Bordeaux, 146 rue Léo Saignat, 33076 Bordeaux, France; PACCI/ANRS research site in Côte d'Ivoire, Côte d'Ivoire.""}, {'ForeName': ""Thomas-d'Aquin"", 'Initials': 'TD', 'LastName': 'Toni', 'Affiliation': ""Centre Inserm 1219, Institut de Recherche pour le Développement (IRD), University of Bordeaux, 146 rue Léo Saignat, 33076 Bordeaux, France; PACCI/ANRS research site in Côte d'Ivoire, Côte d'Ivoire; CeDReS, CHU de Treichville, Abidjan, Côte d'Ivoire.""}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Karcher', 'Affiliation': ""Centre Inserm 1219, Institut de Recherche pour le Développement (IRD), University of Bordeaux, 146 rue Léo Saignat, 33076 Bordeaux, France; PACCI/ANRS research site in Côte d'Ivoire, Côte d'Ivoire.""}, {'ForeName': 'Jérome Le', 'Initials': 'JL', 'LastName': 'Carrou', 'Affiliation': ""Centre Inserm 1219, Institut de Recherche pour le Développement (IRD), University of Bordeaux, 146 rue Léo Saignat, 33076 Bordeaux, France; PACCI/ANRS research site in Côte d'Ivoire, Côte d'Ivoire.""}, {'ForeName': 'Hervé', 'Initials': 'H', 'LastName': 'Ménan', 'Affiliation': ""Centre Inserm 1219, Institut de Recherche pour le Développement (IRD), University of Bordeaux, 146 rue Léo Saignat, 33076 Bordeaux, France; PACCI/ANRS research site in Côte d'Ivoire, Côte d'Ivoire; CeDReS, CHU de Treichville, Abidjan, Côte d'Ivoire.""}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Danel', 'Affiliation': ""Centre Inserm 1219, Institut de Recherche pour le Développement (IRD), University of Bordeaux, 146 rue Léo Saignat, 33076 Bordeaux, France; PACCI/ANRS research site in Côte d'Ivoire, Côte d'Ivoire.""}, {'ForeName': 'Serge P', 'Initials': 'SP', 'LastName': 'Eholie', 'Affiliation': ""Centre Inserm 1219, Institut de Recherche pour le Développement (IRD), University of Bordeaux, 146 rue Léo Saignat, 33076 Bordeaux, France; PACCI/ANRS research site in Côte d'Ivoire, Côte d'Ivoire; Département de Dermatologie et Maladies Infectieuses, Université Felix Houphouët Boigny, Abidjan, Côte d'Ivoire.""}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Rouzioux', 'Affiliation': ""PACCI/ANRS research site in Côte d'Ivoire, Côte d'Ivoire; AP-HP, CHU Necker Enfants Malades, EA 7327 Université Paris Descartes, Paris, France.""}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Anglaret', 'Affiliation': ""Centre Inserm 1219, Institut de Recherche pour le Développement (IRD), University of Bordeaux, 146 rue Léo Saignat, 33076 Bordeaux, France; PACCI/ANRS research site in Côte d'Ivoire, Côte d'Ivoire.""}]",EBioMedicine,['10.1016/j.ebiom.2020.102815'] 1672,32510985,Large Drill Holes Are Still Present in the Long Term After Arthroscopic Bankart Repair With Absorbable Tacks: An 18-Year Randomized Prospective Study.,"BACKGROUND Studies have demonstrated the development of an osseous reaction at the drill sites of anchors after arthroscopic shoulder surgery. PURPOSE To investigate the drill-hole size at 18 years after arthroscopic Bankart repair using either fast polygluconate acid (PGA) or slow polylevolactic acid (PLLA) absorbable tacks and to compare the functional outcomes and development of osteoarthritis. STUDY DESIGN Randomized controlled trial; Level of evidence, 2. METHODS 40 patients with unidirectional anterior shoulder instability, treated with arthroscopic Bankart repair, were randomized into the PGA group (n = 20) or the PLLA group (n = 20). Plain radiographs of both shoulders, as well as computed tomography (CT) images of the operated shoulder, were used to evaluate the drill-hole size, volume, and degenerative changes. Functional outcomes were assessed by use of the Rowe score, Constant score, and Western Ontario Shoulder Instability (WOSI) index. RESULTS Of the 40 patients, 32 patients returned for the follow-up (15 PGA and 17 PLLA). No significant differences were found in the population characteristics between the study groups. The mean follow-up time was 18 years for both groups. No significant differences were seen in range of motion, strength in abduction, or Constant, Rowe, and WOSI scores between the groups. Recurrence rate was 33% in the PGA group and 6% in the PLLA group during the follow-up period ( P = .07). The drill-hole appearance on plain radiographs (invisible/hardly visible/visible/cystic) was 11/2/2/0 and 6/5/5/1 for the PGA and PLLA groups, respectively ( P = .036). The mean ± SD drill-hole volume as estimated on CT images was 89 ± 94 and 184 ± 158 mm 3 in the PGA and PLLA groups, respectively ( P = .051). Degenerative changes (normal/minor/moderate/severe) on plain radiographs were 7/4/4/0 and 3/8/5/1 for the PGA and PLLA groups, respectively ( P = .21), and on CT images were 5/7/3/0 and 2/6/6/3 for the PGA and PLLA groups, respectively ( P = .030). CONCLUSION This long-term follow-up study demonstrated that the PLLA group had significantly more visible drill holes than the PGA group on plain radiographs. However, this difference was not evident on CT imaging, with both groups having several visible cystic drill holes and a substantial drill-hole volume defect. No significant differences were found between the study groups in terms of clinical outcomes.",2020,Recurrence rate was 33% in the PGA group and 6% in the PLLA group during the follow-up period ( P = .07).,"['40 patients with unidirectional anterior shoulder instability, treated with arthroscopic Bankart repair', '40 patients']","['arthroscopic Bankart repair using either fast polygluconate acid (PGA) or slow polylevolactic acid (PLLA) absorbable tacks', 'Arthroscopic Bankart Repair With Absorbable Tacks', 'PGA', 'PLLA']","['Degenerative changes', 'plain radiographs', 'Rowe score, Constant score, and Western Ontario Shoulder Instability (WOSI) index', 'CT images', 'range of motion, strength in abduction, or Constant, Rowe, and WOSI scores', 'Recurrence rate', 'visible drill holes', 'drill-hole appearance on plain radiographs', 'mean ± SD drill-hole volume']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0575624', 'cui_str': 'Shoulder joint unstable'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0408087', 'cui_str': 'Arthroscopic reattachment glenoid labrum'}]","[{'cui': 'C0408087', 'cui_str': 'Arthroscopic reattachment glenoid labrum'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0001128', 'cui_str': 'Acid'}, {'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C1101255', 'cui_str': 'polylevolactic acid'}, {'cui': 'C3874006', 'cui_str': 'Tack'}]","[{'cui': 'C0011164', 'cui_str': 'Degeneration'}, {'cui': 'C1306645', 'cui_str': 'Plain radiography'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C0575624', 'cui_str': 'Shoulder joint unstable'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0086505', 'cui_str': 'Kidnapping'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0205379', 'cui_str': 'Visible'}, {'cui': 'C0324815', 'cui_str': 'Mandrillus leucophaeus'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449468', 'cui_str': 'Volume'}]",40.0,0.0322059,Recurrence rate was 33% in the PGA group and 6% in the PLLA group during the follow-up period ( P = .07).,"[{'ForeName': 'Christina Chrysanthou', 'Initials': 'CC', 'LastName': 'Constantinou', 'Affiliation': 'NU Hospital Group, Department of Orthopaedics, Trollhättan, Sweden.'}, {'ForeName': 'Ninni', 'Initials': 'N', 'LastName': 'Sernert', 'Affiliation': 'Department of Research and Development, NU Hospital Group, Trollhättan, Sweden.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Rostgård-Christensen', 'Affiliation': 'Department of Radiology, Lidköping Hospital, Lidköping, Sweden.'}, {'ForeName': 'Jüri', 'Initials': 'J', 'LastName': 'Kartus', 'Affiliation': 'NU Hospital Group, Department of Orthopaedics, Trollhättan, Sweden.'}]",The American journal of sports medicine,['10.1177/0363546520922191'] 1673,32517165,When Do Good Deeds Lead to Good Feelings? Eudaimonic Orientation Moderates the Happiness Benefits of Prosocial Behavior.,"Engaging in prosocial behavior is considered an effective way to increase happiness in a sustainable manner. However, there is insufficient knowledge about the conditions under which such a happiness effect occurs. From a person-activity congruence perspective, we proposed that an individual's eudaimonic orientation moderates the effect of prosocial behavior on happiness, whereas hedonic orientation does not. For this purpose, 128 participants were assigned to play a game in which half of them were explained the benevolence impact of playing the game (the benevolence condition), and the other half played the same game without this knowledge (the control condition). Participants' eudaimonic and hedonic orientations were assessed before the game, and their post-task happiness were measured after the game. The results showed that participants in the benevolence condition reported higher post-task positive affect than those in the control condition. Furthermore, this happiness effect was moderated by participants' eudaimonic orientation-participants with high eudaimonic orientation reaped greater benefits from benevolence, and their hedonic orientation did not moderate the relationship between benevolence and happiness. The importance of the effect of person-activity congruence on happiness is discussed, along with the implications of these findings for sustainably pursuing happiness.",2020,The results showed that participants in the benevolence condition reported higher post-task positive affect than those in the control condition.,['128 participants'],[],"['eudaimonic and hedonic orientations', 'higher post-task positive affect']",[],[],"[{'cui': 'C0029266', 'cui_str': 'Orientation'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0001721', 'cui_str': 'Affect'}]",128.0,0.0317442,The results showed that participants in the benevolence condition reported higher post-task positive affect than those in the control condition.,"[{'ForeName': 'Weipeng', 'Initials': 'W', 'LastName': 'Lai', 'Affiliation': 'Department of Psychology and Behavioral Sciences, Zhejiang University, Hangzhou 310058, China.'}, {'ForeName': 'Zhixu', 'Initials': 'Z', 'LastName': 'Yang', 'Affiliation': 'Department of Psychology and Behavioral Sciences, Zhejiang University, Hangzhou 310058, China.'}, {'ForeName': 'Yanhui', 'Initials': 'Y', 'LastName': 'Mao', 'Affiliation': 'Department of Psychology and Behavioral Sciences, Zhejiang University, Hangzhou 310058, China.'}, {'ForeName': 'Qionghan', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': 'Department of Psychology and Behavioral Sciences, Zhejiang University, Hangzhou 310058, China.'}, {'ForeName': 'Hezhi', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'Department of Psychology and Behavioral Sciences, Zhejiang University, Hangzhou 310058, China.'}, {'ForeName': 'Jianhong', 'Initials': 'J', 'LastName': 'Ma', 'Affiliation': 'Department of Psychology and Behavioral Sciences, Zhejiang University, Hangzhou 310058, China.'}]",International journal of environmental research and public health,['10.3390/ijerph17114053'] 1674,32527268,Neurophysiological signatures of hand motor response to dual-transcranial direct current stimulation in subacute stroke: a TMS and MEG study.,"BACKGROUND Dual transcranial direct current stimulation (tDCS) to the bilateral primary motor cortices (M1s) has potential benefits in chronic stroke, but its effects in subacute stroke, when behavioural effects might be expected to be greater, have been relatively unexplored. Here, we examined the neurophysiological effects and the factors influencing responsiveness of dual-tDCS in subacute stroke survivors. METHODS We conducted a randomized sham-controlled crossover study in 18 survivors with first-ever, unilateral subcortical ischaemic stroke 2-4 weeks after stroke onset and 14 matched healthy controls. Participants had real dual-tDCS (with an ipsilesional [right for controls] M1 anode and a contralesional M1 [left for controls] cathode; 2 mA for 20mins) and sham dual-tDCS on separate days, with concurrent paretic [left for controls] hand exercise. Using transcranial magnetic stimulation (TMS) and magnetoencephalography (MEG), we recorded motor evoked potentials (MEPs), the ipsilateral silent period (iSP), short-interval intracortical inhibition, and finger movement-related cortical oscillations before and immediately after tDCS. RESULTS Stroke survivors had decreased excitability in ipsilesional M1 with a relatively excessive transcallosal inhibition from the contralesional to ipsilesional hemisphere at baseline compared with controls, as quantified by decreased MEPs and increased iSP duration. Dual-tDCS led to increased MEPs and decreased iSP duration in ipsilesional M1. The magnitude of the tDCS-induced MEP increase in stroke survivors was predicted by baseline contralesional-to-ipsilesional transcallosal inhibition (iSP) ratio. Baseline post-movement synchronization in α-band activity in ipsilesional M1 was decreased after stroke compared with controls, and its tDCS-induced increase correlated with upper limb score in stroke survivors. No significant adverse effects were observed during or after dual-tDCS. CONCLUSIONS Task-concurrent dual-tDCS in subacute stroke can safely and effectively modulate bilateral M1 excitability and inter-hemispheric imbalance and also movement-related α-activity.",2020,"Baseline post-movement synchronization in α-band activity in ipsilesional M1 was decreased after stroke compared with controls, and its tDCS-induced increase correlated with upper limb score in stroke survivors.","['subacute stroke survivors', '18 survivors with first-ever, unilateral subcortical ischaemic stroke 2-4\u2009weeks after stroke onset and 14 matched healthy controls', 'subacute stroke', 'Participants had real dual-tDCS (with an ipsilesional [right for controls] M1 anode and a contralesional M1 [left for controls] cathode; 2\u2009mA for 20mins) and']","['Dual transcranial direct current stimulation (tDCS', 'Task-concurrent dual-tDCS', 'transcranial magnetic stimulation (TMS) and magnetoencephalography (MEG', 'concurrent paretic [left for controls] hand exercise', 'dual-transcranial direct current stimulation', 'sham dual-tDCS']","['α-band activity in ipsilesional M1', 'stroke survivors', 'upper limb score', 'bilateral M1 excitability and inter-hemispheric imbalance', 'excitability in ipsilesional M1', 'adverse effects', 'motor evoked potentials (MEPs), the ipsilateral silent period (iSP), short-interval intracortical inhibition, and finger movement-related cortical oscillations', 'iSP duration']","[{'cui': 'C0205365', 'cui_str': 'Subacute'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0003103', 'cui_str': 'Anode'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0007441', 'cui_str': 'Cathode'}]","[{'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation'}, {'cui': 'C0024489', 'cui_str': 'Magnetoencephalography'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0454330', 'cui_str': 'Hand exercises'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0175723', 'cui_str': 'Band'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0235169', 'cui_str': 'Excitability'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0205139', 'cui_str': 'Hemispheric'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0282617', 'cui_str': 'Motor Evoked Potentials'}, {'cui': 'C0441989', 'cui_str': 'Ipsilateral'}, {'cui': 'C0443304', 'cui_str': 'Silent'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0016129', 'cui_str': 'Digit of hand structure'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C0425943', 'cui_str': 'Duration of menstrual flow'}]",18.0,0.0623601,"Baseline post-movement synchronization in α-band activity in ipsilesional M1 was decreased after stroke compared with controls, and its tDCS-induced increase correlated with upper limb score in stroke survivors.","[{'ForeName': 'I-Ju', 'Initials': 'IJ', 'LastName': 'Kuo', 'Affiliation': 'Institute of Brain Science, Brain Research Center, National Yang-Ming University, No.155, Sec. 2, Linong St., Beitou Dist, Taipei City, 112, Taiwan.'}, {'ForeName': 'Chih-Wei', 'Initials': 'CW', 'LastName': 'Tang', 'Affiliation': 'Institute of Brain Science, Brain Research Center, National Yang-Ming University, No.155, Sec. 2, Linong St., Beitou Dist, Taipei City, 112, Taiwan.'}, {'ForeName': 'Yun-An', 'Initials': 'YA', 'LastName': 'Tsai', 'Affiliation': 'Department of Neurosurgery, Taipei Veterans General Hospital, No.201, Sec. 2, Shipai Rd., Beitou Dist, Taipei City, 112, Taiwan.'}, {'ForeName': 'Shuen-Chang', 'Initials': 'SC', 'LastName': 'Tang', 'Affiliation': 'Department of Neurosurgery, Taipei Veterans General Hospital, No.201, Sec. 2, Shipai Rd., Beitou Dist, Taipei City, 112, Taiwan.'}, {'ForeName': 'Chun-Jen', 'Initials': 'CJ', 'LastName': 'Lin', 'Affiliation': 'Institute of Brain Science, Brain Research Center, National Yang-Ming University, No.155, Sec. 2, Linong St., Beitou Dist, Taipei City, 112, Taiwan.'}, {'ForeName': 'Shih-Pin', 'Initials': 'SP', 'LastName': 'Hsu', 'Affiliation': 'Institute of Brain Science, Brain Research Center, National Yang-Ming University, No.155, Sec. 2, Linong St., Beitou Dist, Taipei City, 112, Taiwan.'}, {'ForeName': 'Wei-Kuang', 'Initials': 'WK', 'LastName': 'Liang', 'Affiliation': 'Institute of Cognitive Neuroscience, National Central University, No.300, Zhongda Rd., Zhongli Dist, Taoyuan City, 320, Taiwan.'}, {'ForeName': 'Chi-Hung', 'Initials': 'CH', 'LastName': 'Juan', 'Affiliation': 'Institute of Cognitive Neuroscience, National Central University, No.300, Zhongda Rd., Zhongli Dist, Taoyuan City, 320, Taiwan.'}, {'ForeName': 'Catharina', 'Initials': 'C', 'LastName': 'Zich', 'Affiliation': 'Wellcome Centre for Integrative Neuroimaging, FMRIB, Nuffield Department of Clinical Neurosciences, University of Oxford, Oxford, OX3 9DU, UK.'}, {'ForeName': 'Charlotte J', 'Initials': 'CJ', 'LastName': 'Stagg', 'Affiliation': 'Wellcome Centre for Integrative Neuroimaging, FMRIB, Nuffield Department of Clinical Neurosciences, University of Oxford, Oxford, OX3 9DU, UK.'}, {'ForeName': 'I-Hui', 'Initials': 'IH', 'LastName': 'Lee', 'Affiliation': 'Institute of Brain Science, Brain Research Center, National Yang-Ming University, No.155, Sec. 2, Linong St., Beitou Dist, Taipei City, 112, Taiwan. ihlee@vghtpe.gov.tw.'}]",Journal of neuroengineering and rehabilitation,['10.1186/s12984-020-00706-1'] 1675,32531070,Effect of different general anaesthetics on ventricular repolarisation in robot-assisted laparoscopic prostatectomy.,"BACKGROUND Ventricular repolarisation is affected differently by the types of anaesthetics used. This study aimed to compare the effect of different types of anaesthetics on ventricular repolarisation during robot-assisted laparoscopic radical prostatectomy (RALP). METHODS Sixty-nine patients were randomly assigned in a 1:1:1 ratio to the Sevoflurane (sevoflurane/remifentanil), Desflurane (desflurane/remifentanil) or total intravenous anaesthesia (TIVA [propofol/remifentanil]) groups; however, only 67 patients completed the study. The primary outcome was heart rate-corrected QT (QTc) interval collected at nine time points during RALP. Bazett's (QTcB) and Fridericia's (QTcF) formulae were used for QT interval correction. The secondary outcomes were Tpeak-Tend (Tp-e) interval and Tp-e/QT ratio that were collected at the same time points. RESULTS The QTcB and QTcF intervals were significantly prolonged during surgery in all groups; however, these values showed significant intergroup differences with time. After assuming the Trendelenburg position, the QTcB and QTcF intervals were significantly longer in the Desflurane group than in the other two groups, and this prolongation continued until the end of surgery. Intra-operatively, the QTcB and QTcF intervals exceeded 450 ms in six and five patients, respectively, in the Desflurane group, but in none in the TIVA group. Moreover, the incidence of intra-operative QTc interval prolongation >20 ms and >60 ms was significantly higher in the Desflurane group than in the TIVA group. There were no significant differences in Tp-e intervals and Tp-e/QT ratio among the three groups during surgery. CONCLUSIONS To minimise QTc interval prolongation during RALP, TIVA with propofol/remifentanil is recommended for general anaesthesia.",2020,"There were no significant differences in Tp-e intervals and Tp-e/QT ratio among the three groups during surgery. ","['Sixty-nine patients', '67 patients completed the study']","['general anaesthetics', 'robot-assisted laparoscopic prostatectomy', 'propofol/remifentanil', 'anaesthetics', 'Desflurane', 'robot-assisted laparoscopic radical prostatectomy (RALP', 'total intravenous anaesthesia (TIVA [propofol/remifentanil', 'Sevoflurane (sevoflurane/remifentanil', 'Desflurane (desflurane/remifentanil']","['ventricular repolarisation', 'QTcB and QTcF intervals', 'intraoperative QTc interval prolongation', 'Tp-e intervals and Tp-e/QT ratio', 'Tpeak-Tend (Tp-e) interval and Tp-e/QT ratio', ""Bazett's (QTcB) and Fridericia's (QTcF) formulae"", 'heart rate-corrected QT (QTc) interval']","[{'cui': 'C0450388', 'cui_str': '69'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0002915', 'cui_str': 'General anesthesia'}, {'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0033573', 'cui_str': 'Prostatectomy'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C0002930', 'cui_str': 'Anesthetics'}, {'cui': 'C0063252', 'cui_str': 'desflurane'}, {'cui': 'C4039115', 'cui_str': 'Robot assisted laparoscopic radical prostatectomy'}, {'cui': 'C0194810', 'cui_str': 'Radical prostatectomy'}, {'cui': 'C0473965', 'cui_str': 'Total intravenous anesthesia'}, {'cui': 'C3854651', 'cui_str': 'TIVA'}, {'cui': 'C0074414', 'cui_str': 'sevoflurane'}]","[{'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0860814', 'cui_str': 'QTc'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0429028', 'cui_str': 'QT interval feature'}]",69.0,0.0291972,"There were no significant differences in Tp-e intervals and Tp-e/QT ratio among the three groups during surgery. ","[{'ForeName': 'Jin Ha', 'Initials': 'JH', 'LastName': 'Park', 'Affiliation': 'Department of Anaesthesiology and Pain Medicine, Anaesthesia and Pain Research Institute, Yonsei University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Ki-Young', 'Initials': 'KY', 'LastName': 'Lee', 'Affiliation': 'Department of Anaesthesiology and Pain Medicine, Anaesthesia and Pain Research Institute, Yonsei University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Young Deuk', 'Initials': 'YD', 'LastName': 'Choi', 'Affiliation': 'Department of Urology, Yonsei University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Jongsoo', 'Initials': 'J', 'LastName': 'Lee', 'Affiliation': 'Department of Urology, Yonsei University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Hye Jung', 'Initials': 'HJ', 'LastName': 'Shin', 'Affiliation': 'Biostatistics Collaboration Unit, Yonsei University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Dong Woo', 'Initials': 'DW', 'LastName': 'Han', 'Affiliation': 'Department of Anaesthesiology and Pain Medicine, Anaesthesia and Pain Research Institute, Yonsei University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Jiwon', 'Initials': 'J', 'LastName': 'Baek', 'Affiliation': 'Department of Anaesthesiology and Pain Medicine, Anaesthesia and Pain Research Institute, Yonsei University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'So Yeon', 'Initials': 'SY', 'LastName': 'Kim', 'Affiliation': 'Department of Anaesthesiology and Pain Medicine, Anaesthesia and Pain Research Institute, Yonsei University College of Medicine, Seoul, Republic of Korea.'}]",Acta anaesthesiologica Scandinavica,['10.1111/aas.13653'] 1676,32531115,"Efficacy of cold atmospheric plasma vs. diclofenac 3% gel in patients with actinic keratoses: a prospective, randomized and rater-blinded study (ACTICAP).",,2020,Actinic keratoses (AK) represent the most common skin malignancy worldwide and are considered the earliest stage in cutaneous squamous cell carcinoma development.,"['Actinic keratoses (AK', 'patients with actinic keratoses']","['Cold atmospheric plasma (CAP', 'CAP', 'cold atmospheric plasma versus diclofenac']",[],"[{'cui': 'C0439681', 'cui_str': 'Actinic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0009264', 'cui_str': 'Low temperature'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0012091', 'cui_str': 'Diclofenac'}]",[],,0.0942484,Actinic keratoses (AK) represent the most common skin malignancy worldwide and are considered the earliest stage in cutaneous squamous cell carcinoma development.,"[{'ForeName': 'F', 'Initials': 'F', 'LastName': 'Koch', 'Affiliation': 'Department of Dermatology, University Hospital of Essen, University Duisburg-Essen and German Cancer Consortium (DKTK) partner site Essen/Düsseldorf, Essen, Germany.'}, {'ForeName': 'K A', 'Initials': 'KA', 'LastName': 'Salva', 'Affiliation': 'Department of Dermatology, University Hospital of Essen, University Duisburg-Essen and German Cancer Consortium (DKTK) partner site Essen/Düsseldorf, Essen, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Wirtz', 'Affiliation': 'SanaSkin, Zürich, Switzerland.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Hadaschik', 'Affiliation': 'Department of Dermatology, University Hospital of Essen, University Duisburg-Essen and German Cancer Consortium (DKTK) partner site Essen/Düsseldorf, Essen, Germany.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Varaljai', 'Affiliation': 'Department of Dermatology, University Hospital of Essen, University Duisburg-Essen and German Cancer Consortium (DKTK) partner site Essen/Düsseldorf, Essen, Germany.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Schadendorf', 'Affiliation': 'Department of Dermatology, University Hospital of Essen, University Duisburg-Essen and German Cancer Consortium (DKTK) partner site Essen/Düsseldorf, Essen, Germany.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Roesch', 'Affiliation': 'Department of Dermatology, University Hospital of Essen, University Duisburg-Essen and German Cancer Consortium (DKTK) partner site Essen/Düsseldorf, Essen, Germany.'}]",Journal of the European Academy of Dermatology and Venereology : JEADV,['10.1111/jdv.16735'] 1677,32531253,The stability of children's salivary peptidome profiles in response to short-term beverage consumption.,"BACKGROUND Salivary peptidome profiling analysis has advantages of simplicity and non-invasiveness and great potentiality for screening, monitoring or primary diagnosis of diseases, but may be subjected to change against interferences like diet. METHODS We conducted a 5-day study to investigate the influence of 3 kinds of beverages (orange juice, sugar-free tea, and sugar-free liquid yoghurt; water as control) on children's salivary peptidome using mass spectrometry techniques. RESULTS All the groups shared a relatively stable pattern in heatmaps during the experimental days. Principal component analysis plot presented slight shifts in all the intervention groups between the baseline and intervention period while samples were not distinctly separated by date. The numbers of significantly changed peptides after short-term orange juice and tea intervention were four and three, respectively, while no changes occurred in the yoghurt group and control. Four of these peptides were identified as histatin-3, collagen alpha-1(IV) chain, zinc finger protein 805, and quinolinate synthase A. CONCLUSIONS Salivary peptidome has its own stability against beverage intervention, confirming the feasibility and validity of using it as a potential reference for the healthy state of the body, with diet habits recorded and considered as a confounder if necessary.",2020,"Four of these peptides were identified as histatin-3, collagen alpha-1(IV) chain, zinc finger protein 805, and quinolinate synthase A. CONCLUSIONS ","[""children's salivary peptidome using mass spectrometry techniques""]","['beverages (orange juice, sugar-free tea, and sugar-free liquid yoghurt; water as control']",[],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0037813', 'cui_str': 'Mass spectrometry measurement'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0001967', 'cui_str': 'Alcoholic beverage'}, {'cui': 'C0452458', 'cui_str': 'Orange juice'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0039400', 'cui_str': 'Tea'}, {'cui': 'C0301571', 'cui_str': 'Liquid diet'}, {'cui': 'C0043419', 'cui_str': 'Yogurt'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",[],,0.020256,"Four of these peptides were identified as histatin-3, collagen alpha-1(IV) chain, zinc finger protein 805, and quinolinate synthase A. CONCLUSIONS ","[{'ForeName': 'Fangqiao', 'Initials': 'F', 'LastName': 'Wei', 'Affiliation': 'Department of Preventive Dentistry, Peking University School and Hospital of Stomatology, National Clinical Research Center for Oral Diseases, National Engineering Laboratory for Digital and Material Technology of Stomatology, Beijing Key Laboratory of Digital Stomatology, Beijing, PR China.'}, {'ForeName': 'Xiangyu', 'Initials': 'X', 'LastName': 'Sun', 'Affiliation': 'Department of Preventive Dentistry, Peking University School and Hospital of Stomatology, National Clinical Research Center for Oral Diseases, National Engineering Laboratory for Digital and Material Technology of Stomatology, Beijing Key Laboratory of Digital Stomatology, Beijing, PR China.'}, {'ForeName': 'Peiyuan', 'Initials': 'P', 'LastName': 'Tong', 'Affiliation': 'Department of Preventive Dentistry, Peking University School and Hospital of Stomatology, National Clinical Research Center for Oral Diseases, National Engineering Laboratory for Digital and Material Technology of Stomatology, Beijing Key Laboratory of Digital Stomatology, Beijing, PR China.'}, {'ForeName': 'Yufeng', 'Initials': 'Y', 'LastName': 'Gao', 'Affiliation': 'Department of Preventive Dentistry, Peking University School and Hospital of Stomatology, National Clinical Research Center for Oral Diseases, National Engineering Laboratory for Digital and Material Technology of Stomatology, Beijing Key Laboratory of Digital Stomatology, Beijing, PR China.'}, {'ForeName': 'Ce', 'Initials': 'C', 'LastName': 'Zhu', 'Affiliation': 'Department of Preventive Dentistry, Peking University School and Hospital of Stomatology, National Clinical Research Center for Oral Diseases, National Engineering Laboratory for Digital and Material Technology of Stomatology, Beijing Key Laboratory of Digital Stomatology, Beijing, PR China.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Chen', 'Affiliation': 'Central Laboratory, Peking University School and Hospital of Stomatology, National Clinical Research Center for Oral Diseases, National Engineering Laboratory for Digital and Material Technology of Stomatology, Beijing Key Laboratory of Digital Stomatology, Beijing, PR China.'}, {'ForeName': 'Shuguo', 'Initials': 'S', 'LastName': 'Zheng', 'Affiliation': 'Department of Preventive Dentistry, Peking University School and Hospital of Stomatology, National Clinical Research Center for Oral Diseases, National Engineering Laboratory for Digital and Material Technology of Stomatology, Beijing Key Laboratory of Digital Stomatology, Beijing, PR China. Electronic address: kqzsg86@bjmu.edu.cn.'}]",Clinica chimica acta; international journal of clinical chemistry,['10.1016/j.cca.2020.06.018'] 1678,32502705,The efficacy of transversus abdominis plane block with or without dexmedetomidine for postoperative analgesia in renal transplantation. A randomized controlled trial.,"BACKGROUND Current options for effective postoperative analgesia after renal transplantation are limited, due to altered renal clearance and the risk of renal damage. This study compared the analgesic effect of the transversus abdominis plane block, with or without dexmedetomidine, in renal transplant recipients. MATERIALS AND METHODS This prospective randomized double-blinded clinical trial was performed from November 2014 to March 2017. Patients were randomly divided into group C (morphine intravenous patient-controlled analgesia), group R (morphine intravenous patient-controlled analgesia and transversus abdominis plane block), and group RD (morphine intravenous patient-controlled analgesia and transversus abdominis plane block with 1 μg/kg dexmedetomidine). Morphine consumption, time to first request for analgesia, pain, sedation, nausea, vomiting, respiratory depression, and bradycardia were measured at 2, 4, 6, 12 and 24 h after surgery. RESULTS The visual analogue pain score in group C was the highest among the three groups at the 2nd and 4th hour. Morphine consumption was the highest in group C at all assessed time intervals (p < 0.01). By the 12th hour and 24th hour, morphine consumption (calculated by time interval) was the lowest in group RD (p < 0.05), while no statistical difference was found between groups C and R. The average time to first request of analgesia was the longest and shortest in group RD and group C, respectively (p < 0.01). The overall incidence of nausea and vomiting was the highest in group C (p < 0.05). CONCLUSIONS The transversus abdominis plane block reduced morphine consumption in the first 24 h following renal transplantation, and the addition of dexmedetomidine provided a more effective analgesic effect.",2020,The visual analogue pain score in group C was the highest among the three groups at the 2nd and 4th hour.,"['renal transplant recipients', 'November 2014 to March 2017', 'renal transplantation']","['C (morphine intravenous patient-controlled analgesia), group R (morphine intravenous patient-controlled analgesia and transversus abdominis plane block), and group RD (morphine intravenous patient-controlled analgesia and transversus abdominis plane block with 1 μg/kg dexmedetomidine', 'transversus abdominis plane block with or without dexmedetomidine', 'dexmedetomidine', 'transversus abdominis plane block, with or without dexmedetomidine']","['visual analogue pain score', 'Morphine consumption, time to first request for analgesia, pain, sedation, nausea, vomiting, respiratory depression, and bradycardia', 'nausea and vomiting', 'morphine consumption', 'effective analgesic effect', 'Morphine consumption', 'average time to first request of analgesia']","[{'cui': 'C0022671', 'cui_str': 'Transplant of kidney'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}]","[{'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0078944', 'cui_str': 'Patient controlled analgesia'}, {'cui': 'C0441852', 'cui_str': 'Group R'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}]","[{'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0686900', 'cui_str': 'Request for'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0235063', 'cui_str': 'Decreased respiratory function'}, {'cui': 'C0428977', 'cui_str': 'Bradycardia'}, {'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0948482', 'cui_str': 'Analgesic effect'}, {'cui': 'C1272683', 'cui_str': 'Requested'}]",,0.113764,The visual analogue pain score in group C was the highest among the three groups at the 2nd and 4th hour.,"[{'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Yang', 'Affiliation': 'Department of Anesthesiology, The First Affiliated Hospital, Sun Yat-sen University, No.58, Zhongshan 2nd Road, 510080, Guangzhou, China.'}, {'ForeName': 'Yanhua', 'Initials': 'Y', 'LastName': 'Luo', 'Affiliation': 'Department of Anesthesiology, Zhongshan Ophthalmic Center, Sun Yat-sen University, No.54 Xianlie South Road, 510060, Guangzhou, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Lin', 'Affiliation': 'Department of Anesthesiology, The First Affiliated Hospital, Sun Yat-sen University, No.58, Zhongshan 2nd Road, 510080, Guangzhou, China.'}, {'ForeName': 'Hufei', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Department of Anesthesiology, The First Affiliated Hospital, Sun Yat-sen University, No.58, Zhongshan 2nd Road, 510080, Guangzhou, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Anesthesiology, The First Affiliated Hospital, Sun Yat-sen University, No.58, Zhongshan 2nd Road, 510080, Guangzhou, China.'}, {'ForeName': 'Yunsheng', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Anesthesiology, The First Affiliated Hospital, Sun Yat-sen University, No.58, Zhongshan 2nd Road, 510080, Guangzhou, China. Electronic address: mysjz1@163.com.'}]","International journal of surgery (London, England)",['10.1016/j.ijsu.2020.05.073'] 1679,32503093,Ocrelizumab shorter infusion: Primary results from the ENSEMBLE PLUS substudy in patients with MS.,"OBJECTIVE To assess the safety of ocrelizumab (OCR) shorter duration infusion in patients with MS. METHODS ENSEMBLE PLUS is a randomized, double-blind substudy to the single-arm ENSEMBLE study (NCT03085810). In ENSEMBLE, patients with early stage relapsing-remitting MS received OCR 600 mg initially as two 300 mg IV infusions 2 weeks apart and subsequently as a single 3.5-hour 600 mg infusion every 24 weeks for 192 weeks. In ENSEMBLE PLUS, OCR 600 mg administered over the approved 3.5-hour infusion time (conventional duration) is compared with a 2-hour infusion (shorter duration). The primary end point was the proportion of patients with infusion-related reactions (IRRs) after the first randomized dose (assessed during and up to 24 hours postinfusion). RESULTS From November 1, 2018, to September 27, 2019, 580 patients were randomized 1:1 to the conventional or shorter infusion group. After the first randomized dose, 67 of 291 patients (23.1%) in the conventional and 71 of 289 patients (24.6%) in the shorter infusion group experienced IRRs. Most IRRs were mild or moderate in both groups; one patient in each group experienced a severe IRR, and in both groups, 98.6% (136 of 138) of all IRRs resolved without sequelae. No IRRs were serious, life-threatening, or fatal. No IRR-related discontinuation occurred. During the first randomized dose, 14 of 291 (4.8%) and 25 of 289 (8.7%) patients in the conventional and shorter infusion groups, respectively, had IRRs leading to infusion slowing/interruption. CONCLUSION The frequency and severity of IRRs were similar between conventional and shorter OCR infusions. Shortening the infusion time to 2 hours reduces the total infusion site stay time and lessens the overall patient and site staff burden. CLASSIFICATION OF EVIDENCE This interventional study provides Class I evidence that the frequency and severity of IRRs were similar at the first randomized dose using OCR (600 mg) infusions of conventional and shorter duration in patients with relapsing-remitting MS. CLINICAL TRIAL IDENTIFIER NUMBER NCT03085810.",2020,"Shortening the infusion time to 2 hours reduces the total infusion site stay time and lessens the overall patient and site staff burden. ","['patients with MS', 'From November 1, 2018, to September 27, 2019, 580 patients', 'patients with relapsing-remitting MS', 'patients with early stage relapsing-remitting MS']","['OCR', 'conventional or shorter infusion group', 'Ocrelizumab', 'ocrelizumab (OCR']","['serious, life-threatening, or fatal', 'IRRs leading to infusion slowing/interruption', 'total infusion site stay time and lessens the overall patient and site staff burden', 'IRRs', 'severe IRR', 'proportion of patients with infusion-related reactions (IRRs', 'frequency and severity of IRRs']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517818', 'cui_str': '580'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}]","[{'cui': 'C1882138', 'cui_str': 'ocrelizumab'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C3537125', 'cui_str': 'Common terminology criteria for adverse events grade 4'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0332453', 'cui_str': 'Disruption'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0083017', 'cui_str': 'insulin receptor-related receptor'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",580.0,0.17746,"Shortening the infusion time to 2 hours reduces the total infusion site stay time and lessens the overall patient and site staff burden. ","[{'ForeName': 'Hans-Peter', 'Initials': 'HP', 'LastName': 'Hartung', 'Affiliation': 'From the Department of Neurology, UKD, Center of Neurology and Neuropsychiatry and LVR-Klinikum, Medical Faculty, Heinrich-Heine University Düsseldorf, Germany. hans-peter.hartung@uni-duesseldorf.de.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Neurology(R) neuroimmunology & neuroinflammation,['10.1212/NXI.0000000000000807'] 1680,32503194,Acupuncture Treatment Modulates the Connectivity of Key Regions of the Descending Pain Modulation and Reward Systems in Patients with Chronic Low Back Pain.,"Chronic low back pain (cLBP) is a common disorder with unsatisfactory treatment options. Acupuncture has emerged as a promising method for treating cLBP. However, the mechanism underlying acupuncture remains unclear. In this study, we investigated the modulation effects of acupuncture on resting state functional connectivity (rsFC) of the periaqueductal gray (PAG) and ventral tegmental area (VTA) in patients with cLBP. Seventy-nine cLBP patients were recruited and assigned to four weeks of real or sham acupuncture. Resting state functional magnetic resonance imaging data were collected before the first and after the last treatment. Fifty patients completed the study. We found remission of pain bothersomeness in all treatment groups after four weeks, with greater pain relief after real acupuncture compared to sham acupuncture. We also found that real acupuncture can increase VTA/PAG rsFC with the amygdala, and the increased rsFC was associated with decreased pain bothersomeness scores. Baseline PAG-amygdala rsFC could predict four-week treatment response. Our results suggest that acupuncture may simultaneously modulate the rsFC of key regions in the descending pain modulation (PAG) and reward systems (VTA), and the amygdala may be a key node linking the two systems to produce antinociceptive effects. Our findings highlight the potential of acupuncture for chronic low back pain management.",2020,"We found remission of pain bothersomeness in all treatment groups after four weeks, with greater pain relief after real acupuncture compared to sham acupuncture.","['Patients with Chronic Low Back Pain', 'Fifty patients completed the study', 'patients with cLBP', 'Seventy-nine cLBP patients']","['acupuncture', 'real or sham acupuncture', 'Acupuncture']","['remission of pain bothersomeness', 'pain relief', 'resting state functional connectivity (rsFC) of the periaqueductal gray (PAG) and ventral tegmental area (VTA', 'Chronic low back pain (cLBP', 'pain bothersomeness scores', 'Connectivity of Key Regions of the Descending Pain Modulation and Reward Systems', 'VTA/PAG rsFC']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C3816957', 'cui_str': '70'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0228398', 'cui_str': 'Structure of periaqueductal gray matter'}, {'cui': 'C0175405', 'cui_str': 'Ventral Tegmental Area of Tsai'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0205386', 'cui_str': 'Descending'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0035397', 'cui_str': 'Rewards'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]",79.0,0.121085,"We found remission of pain bothersomeness in all treatment groups after four weeks, with greater pain relief after real acupuncture compared to sham acupuncture.","[{'ForeName': 'Siyi', 'Initials': 'S', 'LastName': 'Yu', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, Charlestown, MA 02129, USA.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Ortiz', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, Charlestown, MA 02129, USA.'}, {'ForeName': 'Randy L', 'Initials': 'RL', 'LastName': 'Gollub', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, Charlestown, MA 02129, USA.'}, {'ForeName': 'Georgia', 'Initials': 'G', 'LastName': 'Wilson', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, Charlestown, MA 02129, USA.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Gerber', 'Affiliation': 'Department of Radiology, Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Harvard Medical School, Charlestown, MA 02129, USA.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Park', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, Charlestown, MA 02129, USA.'}, {'ForeName': 'Yiting', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, Charlestown, MA 02129, USA.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Shen', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, Charlestown, MA 02129, USA.'}, {'ForeName': 'Suk-Tak', 'Initials': 'ST', 'LastName': 'Chan', 'Affiliation': 'Department of Radiology, Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Harvard Medical School, Charlestown, MA 02129, USA.'}, {'ForeName': 'Ajay D', 'Initials': 'AD', 'LastName': 'Wasan', 'Affiliation': 'Department of Anesthesiology, Center for Pain Research, University of Pittsburgh, Pittsburgh, PA 15206, USA.'}, {'ForeName': 'Robert R', 'Initials': 'RR', 'LastName': 'Edwards', 'Affiliation': ""Department of Anesthesiology, Perioperative and Pain Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA 02467, USA.""}, {'ForeName': 'Vitaly', 'Initials': 'V', 'LastName': 'Napadow', 'Affiliation': 'Department of Radiology, Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Harvard Medical School, Charlestown, MA 02129, USA.'}, {'ForeName': 'Ted J', 'Initials': 'TJ', 'LastName': 'Kaptchuk', 'Affiliation': 'Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA 02215, USA.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Rosen', 'Affiliation': 'Department of Radiology, Martinos Center for Biomedical Imaging, Massachusetts General Hospital, Harvard Medical School, Charlestown, MA 02129, USA.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Kong', 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital, Harvard Medical School, Charlestown, MA 02129, USA.'}]",Journal of clinical medicine,['10.3390/jcm9061719'] 1681,32503657,"The Mechanism and Clinical Outcome of patients with Corona Virus Disease 2019 Whose Nucleic Acid Test has changed from negative to positive, and the therapeutic efficacy of Favipiravir: A structured summary of a study protocol for a randomised controlled trial.","OBJECTIVES A variety of possible mechanisms can make the nucleic acid test of patients who meet the discharge conditions positive again, including reinfection, reactivation of the original virus, lack of strict discharge criteria, new infection, and so on. Different reasons will correspond to different prevention and control measures. We will enroll patients who are discharged after treatment, whose nucleic acid test has changed from negative to positive during the screening visit, regardless of the severity of the symptoms, to investigate the mechanism, clinical outcome and therapeutic efficacy with Favipiravir patients with Corona virus Disease 2019. Favipiravir is an anti-viral agent that selectively and potently inhibits the RNA-dependent RNA polymerase, it has been used for treatment of some life-threatening infections such as Ebola virus, Lassa virus and rabies. Its therapeutic efficacy has been proven in these diseases. TRIAL DESIGN This is a multi-center, two arm, open label, parallel group, randomized controlled trial. PARTICIPANTS Eligibility criteria: Inclusion criteria: 1.Adults 18 to 80 years, male or female.2.After the first diagnosis and treatment of COVID-19, the nucleic acid test of respiratory specimens such as sputum or nasopharyngeal swabs, has been negative for two consecutive times (sampling time interval of at least 24 hours), in accordance with the COVID-19's diagnosis and treatment Plan (7th Edition), discharged.3.During screening visit (follow-up after discharge), The nucleic acid test of COVID-19 is positive in any one of the following samples: sputum, throat swabs, blood, feces or other specimens. Regardless of whether or not they had symptoms and the severity of symptoms.4.Volunteer to participate in the research and sign the Informed Consent Form. EXCLUSION CRITERIA 1.Allergic to Favipiravjr;2.Pregnant or lactating women3.Uncontrolled diseases of the blood and cardiovascular system, liver or kidney.4.History of mental disorders, drug abuse or dependence;5.Researchers consider it inappropriate for adults to participate;6.Participating in other clinical studies. Loss to Follow up: Cases that do not complete the clinical trial program will be regarded as lost to follow up. Including the withdrawal of patients by themselves (such as poor compliance, etc.), or the withdrawal of patients ordered by the researcher (those who need other drugs which affect the judgment of the curative effect, and those who need to stop taking drugs for severe adverse events) Study setting: The participating hospitals are some of the designated hospitals that have been or may be admitting patients who meet the eligibility criteria, mainly in Hubei, Shenzhen, Anhui and Beijing. Participants will be recruited from these 15 hospitals: Wuhan Pulmonary Hospital, Hubei; Jinyintan Hospital of Wuhan, Hubei; Ezhou Central Hospital, Hubei; The Second People's Hospital of Fuyang, Anhui; The First Affiliated Hospital of USTC, Anhui; Beijing Youan Hospital, Beijing; Capital Medical University Beijing Institute of Hepatology, Beijing; Ezhou Hospital of Traditional Chinese Medicine, Hubei; Zhongnan Hospital of Wuhan University, Hubei; The Fifth Hospital of ShiJiazhuang, Hebei; Jinan Infectious Diseases Hospital, Shandong; Public Health Clinical Center of Chengdu, Sichuan; Wuxi No.5 People's Hospital, Jiangsu; The Third People's Hospital of Shenzhen, Guangdong; The First Affiliated Hospital of Bengfu Medical College, AnHui. INTERVENTION AND COMPARATOR Favipiravir group (experimental): Favipiravir 1600mg each dose, twice a day on the 1st day; 600mg each dose, twice a day from the 2nd to the 7th day, Oral administration, the maximum number of days taken will be no more than 14 days plus routine treatment for COVID-19. Regular treatment group (control): Treatments other than Antiviral drugs can be given. Routine treatment for patients with the corona virus will be administered, this includes oxygen therapy, drugs that reduced phlegm and relieve cough, including thymosin, proprietary Chinese medicine, etc. MAIN OUTCOMES: Primary Outcome Measures: Viral nucleic acid test negative [Time Frame: 5 months]: Subjects who tested negative for nucleic acid from sputum or nasopharyngeal swabs for two consecutive times (sampling time interval of at least 24 hours). SECONDARY OUTCOME MEASURES Clinical cure [Time Frame: 5 months]: 1.Body temperature returned to normal for more than 3 days;2.Lung image improved.3.Clinical manifestation improved;4.The viral nucleic acid test of respiratory specimens was negative for two consecutive times (sampling time interval of at least 24 hours). RANDOMIZATION The central randomization system (Interactive Web Response Management System), will be used to randomly divide the subjects into the experimental group and the control group according to the ratio of 2:1. In this study, block randomization will be used, in blocks of 6. BLINDING (MASKING) This is an open label trial. Trial participants, investigators, care givers, outcome assessors, and date analysts are not blinded to group assignment. NUMBERS TO BE RANDOMISED 210 patients are expected to be enrolled and allocated according to the ratio of 2 (Favipiravir group, n=140): 1(regular treatment group, n=70). TRIAL STATUS Protocol version number 3.0, 10 th April 2020 First Patient, first visit 17 th March 2020; recruitment end date anticipated June 1, 2020. TRIAL REGISTRATION ClinicalTrials.gov, NCT04333589, April 3, 2020. Registered April 3, 2020. FULL PROTOCOL The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.",2020,"The central randomization system (Interactive Web Response Management System), will be used to randomly divide the subjects into the experimental group and the control group according to the ratio of 2:1.","['patients with Corona Virus Disease 2019', 'patients with the corona virus', 'Participants will be recruited from these 15 hospitals: Wuhan Pulmonary Hospital, Hubei; Jinyintan Hospital of Wuhan, Hubei; Ezhou Central Hospital, Hubei', 'patients with Corona virus Disease 2019', ""Eligibility criteria: Inclusion criteria: 1.Adults 18 to 80 years, male or female.2.After the first diagnosis and treatment of COVID-19, the nucleic acid test of respiratory specimens such as sputum or nasopharyngeal swabs, has been negative for two consecutive times (sampling time interval of at least 24 hours), in accordance with the COVID-19's diagnosis and treatment Plan (7th Edition), discharged.3.During screening visit (follow-up after discharge"", 'Subjects who tested negative for nucleic acid from sputum or nasopharyngeal swabs for two consecutive times (sampling time interval of at least 24 hours', '210 patients are expected to be enrolled and allocated according to the ratio of 2 (Favipiravir group, n=140', 'Protocol version number 3.0, 10 th April 2020']","['Favipiravir', 'Regular treatment group (control']","['Clinical cure', 'severe adverse events', 'Viral nucleic acid test negative']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0042769', 'cui_str': 'Viral disease'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0028606', 'cui_str': 'Nucleic acid'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0038056', 'cui_str': 'Sputum'}, {'cui': 'C0444192', 'cui_str': 'Nasopharyngeal swab'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0441792', 'cui_str': 'Editions'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C4319559', 'cui_str': '210'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C1138226', 'cui_str': 'favipiravir'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]","[{'cui': 'C1138226', 'cui_str': 'favipiravir'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1519275', 'cui_str': 'Common terminology criteria for adverse events grade 3'}, {'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0028606', 'cui_str': 'Nucleic acid'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0205160', 'cui_str': 'Negative'}]",,0.0854545,"The central randomization system (Interactive Web Response Management System), will be used to randomly divide the subjects into the experimental group and the control group according to the ratio of 2:1.","[{'ForeName': 'Jiawen', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Infectious Disease, Center for Liver Disease, Peking University First Hospital, No.8 Xishiku Street, Xicheng District, Beijing, China.'}, {'ForeName': 'Chi', 'Initials': 'C', 'LastName': 'Zhang', 'Affiliation': 'Department of Infectious Disease, Center for Liver Disease, Peking University First Hospital, No.8 Xishiku Street, Xicheng District, Beijing, China.'}, {'ForeName': 'Zhao', 'Initials': 'Z', 'LastName': 'Wu', 'Affiliation': 'Department of Infectious Disease, Center for Liver Disease, Peking University First Hospital, No.8 Xishiku Street, Xicheng District, Beijing, China.'}, {'ForeName': 'Guiqiang', 'Initials': 'G', 'LastName': 'Wang', 'Affiliation': 'Department of Infectious Disease, Center for Liver Disease, Peking University First Hospital, No.8 Xishiku Street, Xicheng District, Beijing, China. john131212@126.com.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Zhao', 'Affiliation': 'Department of Infectious Disease, Center for Liver Disease, Peking University First Hospital, No.8 Xishiku Street, Xicheng District, Beijing, China. haohong_pufh@bjmu.edu.cn.'}]",Trials,['10.1186/s13063-020-04430-y'] 1682,32503662,Norwegian Coronavirus Disease 2019 (NO COVID-19) Pragmatic Open label Study to assess early use of hydroxychloroquine sulphate in moderately severe hospitalised patients with coronavirus disease 2019: A structured summary of a study protocol for a randomised controlled trial.,"OBJECTIVES The hypothesis of the study is that treatment with hydroxychloroquine sulphate in hospitalised patients with coronavirus disease 2019 (Covid-19) is safe and will accelerate the virological clearance rate for patients with moderately severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) when compared to standard care. Furthermore, we hypothesize that early treatment with hydroxychloroquine sulphate is associated with more rapid resolve of clinical symptoms as assessed by the National Early Warning Score 2 (NEWS2), decreased admission rate to intensive care units and mortality, and improvement in protein biomarker profiles (C-reactive protein, markers of renal and hepatic injury, and established cardiac biomarkers like cardiac troponin and B-type natriuretic peptide). TRIAL DESIGN The study is a two-arm, open label, pragmatic randomised controlled group sequential adaptive trial designed to assess the effect on viral loads and clinical outcome of hydroxychloroquine sulphate therapy in addition to standard care compared to standard care alone in patients with established Covid-19. By utilizing resources already paid for by the hospitals (physicians and nurses in daily clinical practice), this pragmatic trial can include a larger number of patients over a short period of time and at a lower cost than studies utilizing traditional randomized controlled trial designs with an external study organization. The pragmatic approach will enable swift initiation of randomisation and allocation to treatment. PARTICIPANTS Patients will be recruited from all inpatients at Akershus University Hospital, Lørenskog, Norway. Electronic real-time surveillance of laboratory reports from the Department of Microbiology will be examined regularly for SARS-CoV-2 positive subjects. All of the following conditions must apply to the prospective patient at screening prior to inclusion: (1) Hospitalisation; (2) Adults 18 years or older; (3) Moderately severe Covid-19 disease (NEWS2 of 6 or less); (4) SARS-CoV-2 positive nasopharyngeal swab; (5) Expected time of hospitalisation > 48 hours; and (6) Signed informed consent must be obtained and documented according to Good Clinical Practice guidelines of the International Conference on Harmonization, and national/local regulations. Patients will be excluded from participation in the study if they meet any of the following criteria: (1) Requiring intensive care unit admission at screening; (2) History of psoriasis; (3) Known adverse reaction to hydroxychloroquine sulphate; (4) Pregnancy; or (5) Prolonged corrected QT interval (>450 ms). Clinical data, including standard hospital biochemistry, medical therapy, vital signs, NEWS2, and microbiology results (including blood culture results and reverse transcriptase polymerase chain reaction [RT-PCR] for other upper airway viruses), will be automatically extracted from the hospital electronic records and merged with the study specific database. INTERVENTION AND COMPARATOR Included patients will be randomised in a 1:1 ratio to (1) standard care with the addition of 400 mg hydroxychloroquine sulphate (Plaquenil TM ) twice daily for seven days or (2) standard care alone. MAIN OUTCOMES The primary endpoint of the study is the rate of decline in SARS-CoV-2 viral load in oropharyngeal samples as assessed by RT-PCR in samples collected at baseline, 48 and 96 hours after randomization and administration of drug for the intervention arm. Secondary endpoints include change in NEWS2 at 96 hours after randomisation, admission to intensive care unit, mortality (in-hospital, and at 30 and 90 days), duration of hospital admission, clinical status on a 7-point ordinal scale 14 days after randomization ([1] Death [2] Hospitalised, on invasive mechanical ventilation or extracorporeal membrane oxygenation [3] Hospitalised, on non-invasive ventilation or high flow oxygen devices [4] Hospitalized, requiring supplemental oxygen [5] Hospitalised, not requiring supplemental oxygen [6] Not hospitalized, but unable to resume normal activities [7] Not hospitalised, with resumption of normal activities), and improvement in protein biomarker profiles (C-reactive protein, markers of renal and hepatic injury, and established cardiac biomarkers like cardiac troponin and B-type natriuretic peptide) at 96 hours after randomization. RANDOMISATION Eligible patients will be allocated in a 1:1 ratio, using a computer randomisation procedure. The allocation sequence has been prepared by an independent statistician. BLINDING (MASKING) Open label randomised controlled pragmatic trial without blinding, no active or placebo control. The virologist assessing viral load in the oropharyngeal samples and the statistician responsible for analysis of the data will be blinded to the treatment allocation for the statistical analyses. NUMBERS TO BE RANDOMIZED (SAMPLE SIZE) This is a group sequential adaptive trial where analyses are planned after 51, 101, 151 and 202 completed patients, with a maximum sample size of 202 patients (101 patients allocated to intervention and standard care and 101 patients allocated to standard care alone). TRIAL STATUS Protocol version 1.3 (March 26, 2020). Recruitment of first patient on March 26, 2020, and 51 patients were included as per April 28, 2020. Study recruitment is anticipated to be completed by July 2020. TRIAL REGISTRATION ClinicalTrials.gov number, NCT04316377. Trial registered March 20, 2020. FULL PROTOCOL The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.",2020,Prolonged corrected QT interval (>450 ms).,"['Recruitment of first patient on March 26, 2020, and 51 patients were included as per April 28, 2020', 'prospective patient at screening prior to inclusion: (1) Hospitalisation; (2) Adults 18 years or older; (3) Moderately severe Covid-19 disease (NEWS2 of 6 or less); (4) SARS-CoV-2 positive nasopharyngeal swab; (5) Expected time of hospitalisation > 48 hours; and (6) Signed informed consent must be obtained and documented according to Good Clinical Practice guidelines of the International Conference on Harmonization, and national/local regulations', 'moderately severe hospitalised patients with coronavirus disease 2019', 'patients with moderately severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2', 'Patients will be excluded from participation in the study if they meet any of the following criteria: (1) Requiring intensive care unit admission at screening; (2) History of psoriasis; (3) Known adverse reaction to hydroxychloroquine sulphate; (4) Pregnancy; or (5', '4] Hospitalized, requiring supplemental oxygen [5] Hospitalised, not requiring supplemental oxygen [6] Not hospitalized, but unable to resume normal activities [7] Not hospitalised, with resumption of normal activities), and improvement in protein biomarker profiles (C-reactive protein, markers of renal and hepatic injury, and established cardiac biomarkers like cardiac troponin and B-type natriuretic peptide) at 96 hours after randomization', 'hospitalised patients with coronavirus disease 2019 (Covid-19', 'patients with established Covid-19', 'Patients will be recruited from all inpatients at Akershus University Hospital, Lørenskog, Norway', 'planned after 51, 101, 151 and 202 completed patients, with a maximum sample size of 202 patients (101 patients allocated to', 'Norwegian Coronavirus Disease 2019']","['hydroxychloroquine sulphate therapy', 'non-invasive ventilation or high flow oxygen devices', 'intervention and standard care and 101 patients allocated to standard care alone', 'placebo control', 'hydroxychloroquine sulphate (Plaquenil TM ) twice daily for seven days or (2) standard care alone', 'hydroxychloroquine sulphate']","['rate of decline in SARS-CoV-2 viral load in oropharyngeal samples as assessed by RT-PCR', 'Prolonged corrected QT interval', 'change in NEWS2 at 96 hours after randomisation, admission to intensive care unit, mortality (in-hospital, and at 30 and 90 days), duration of hospital admission, clinical status on a 7-point ordinal scale 14 days after randomization ([1] Death [2] Hospitalised, on invasive mechanical ventilation or extracorporeal membrane oxygenation', 'virological clearance rate']","[{'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C5197888', 'cui_str': 'Early Warning Score'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0444192', 'cui_str': 'Nasopharyngeal swab'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439586', 'cui_str': '48 hours'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0021430', 'cui_str': 'Informed Consent'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0282451', 'cui_str': 'Clinical Practice Guideline'}, {'cui': 'C0086047', 'cui_str': 'Conferences'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0455567', 'cui_str': 'H/O: psoriasis'}, {'cui': 'C0205309', 'cui_str': 'Known'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0596007', 'cui_str': 'Hydroxychloroquine sulfate'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0566415', 'cui_str': 'Unable to feed self'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0160390', 'cui_str': 'Injury of liver'}, {'cui': 'C0443211', 'cui_str': 'Established'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C1096316', 'cui_str': 'Cardiac troponin'}, {'cui': 'C0054015', 'cui_str': 'Nesiritide'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0028423', 'cui_str': 'Norway'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0242618', 'cui_str': 'Sample Size'}, {'cui': 'C0028424', 'cui_str': 'Norwegian language'}]","[{'cui': 'C0596007', 'cui_str': 'Hydroxychloroquine sulfate'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1997883', 'cui_str': 'Noninvasive ventilation'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0699177', 'cui_str': 'Plaquenil'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C0521367', 'cui_str': 'Oropharyngeal structure'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0599161', 'cui_str': 'Polymerase Chain Reaction, Reverse Transcriptase'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0429028', 'cui_str': 'QT interval feature'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C5197888', 'cui_str': 'Early Warning Score'}, {'cui': 'C1097282', 'cui_str': '2-amino-5-(3,4-dimethoxyphenyl)-1,3,4-thiadiazole'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0583239', 'cui_str': 'Admission to intensive care unit'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0449440', 'cui_str': 'Clinical status'}, {'cui': 'C0163299', 'cui_str': 'A 7'}, {'cui': 'C0439080', 'cui_str': 'Ordinal number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1868981', 'cui_str': 'Invasive mechanical ventilation'}, {'cui': 'C0015357', 'cui_str': 'Extracorporeal membrane oxygenation'}, {'cui': 'C0205466', 'cui_str': 'Virologic'}, {'cui': 'C0025515', 'cui_str': 'Metabolic clearance rate'}]",,0.36269,Prolonged corrected QT interval (>450 ms).,"[{'ForeName': 'Magnus Nakrem', 'Initials': 'MN', 'LastName': 'Lyngbakken', 'Affiliation': 'Division of Medicine, Akershus University Hospital, Lørenskog, Norway.'}, {'ForeName': 'Jan-Erik', 'Initials': 'JE', 'LastName': 'Berdal', 'Affiliation': 'Institute of Clinical Medicine, Faculty of Medicine, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Arne', 'Initials': 'A', 'LastName': 'Eskesen', 'Affiliation': 'Department of Infectious Diseases, Division of Medicine, Akershus University Hospital, Lørenskog, Norway.'}, {'ForeName': 'Dag', 'Initials': 'D', 'LastName': 'Kvale', 'Affiliation': 'Institute of Clinical Medicine, Faculty of Medicine, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Inge Christoffer', 'Initials': 'IC', 'LastName': 'Olsen', 'Affiliation': 'Department of Research Support for Clinical Trials, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Anbjørg', 'Initials': 'A', 'LastName': 'Rangberg', 'Affiliation': 'Center for Laboratory Medicine, Østfold Hospital Trust, Grålum, Norway.'}, {'ForeName': 'Christine Monceyron', 'Initials': 'CM', 'LastName': 'Jonassen', 'Affiliation': 'Center for Laboratory Medicine, Østfold Hospital Trust, Grålum, Norway.'}, {'ForeName': 'Torbjørn', 'Initials': 'T', 'LastName': 'Omland', 'Affiliation': 'Division of Medicine, Akershus University Hospital, Lørenskog, Norway.'}, {'ForeName': 'Helge', 'Initials': 'H', 'LastName': 'Røsjø', 'Affiliation': 'Institute of Clinical Medicine, Faculty of Medicine, University of Oslo, Oslo, Norway. helge.rosjo@medisin.uio.no.'}, {'ForeName': 'Olav', 'Initials': 'O', 'LastName': 'Dalgard', 'Affiliation': 'Institute of Clinical Medicine, Faculty of Medicine, University of Oslo, Oslo, Norway.'}]",Trials,['10.1186/s13063-020-04420-0'] 1683,32507551,Prevalence of NAFLD in Guatemala following exposure to a protein-energy nutrition intervention in early life.,"INTRODUCTION AND OBJECTIVES The global prevalence of non-alcoholic fatty liver disease (NAFLD) is approximately 25%, with Hispanic populations at greatest risk. We describe the prevalence of NAFLD in a cohort of Guatemalan adults and examine whether exposure to a protein-energy supplement from conception to two years is associated with lower prevalence of NAFLD. MATERIALS AND METHODS From 1969 to 1977, four villages in Guatemala were cluster-randomized to receive a protein-energy supplement (Atole) or a no-protein, low-energy beverage (Fresco). We conducted a follow-up of participants from 2015 to 2017. We assessed blood samples (n=1093; 61.1% women; aged 37-53 years) for alanine aminotransferase (ALT) and aspartate aminotransferase (AST) and estimated NAFLD prevalence using the liver fat score. We used generalized linear and logistic models to estimate the difference-in-difference effect of Atole from conception to two years on NAFLD. RESULTS Median ALT and AST were 19.7U/L (interquartile range, IQR: 14.1, 27.4) and 26.0U/L (IQR: 21.4, 32.8), respectively. The median NAFLD liver fat score was 0.2 (IQR: -1.2, 1.6) in women and -1.2 (IQR: -2.2, 0.5) in men (p<0.0001). The prevalence of NAFLD was 67.4% among women and 39.5% among men (p<0.0001). The association between Atole exposure from conception to two years and NAFLD was not significant (OR: 0.90, 95% CI: 0.50-1.63). CONCLUSIONS NAFLD prevalence among Guatemalan adults exceeds the global average. Protein-energy supplementation in early life was not associated with later NAFLD. There is a need for further studies on the causes and onset of NAFLD throughout the life course.",2020,"The median NAFLD liver fat score was 0.2 (IQR: -1.2, 1.6) in women and -1.2 (IQR: -2.2, 0.5) in men (p<0.0001).","['participants from 2015 to 2017', 'From 1969 to 1977, four villages in Guatemala', 'n=1093; 61.1% women; aged 37-53 years) for alanine aminotransferase (ALT) and aspartate aminotransferase (AST) and estimated NAFLD prevalence using the liver fat score']","['Protein-energy supplementation', 'protein-energy nutrition intervention', 'protein-energy supplement (Atole) or a no-protein, low-energy beverage (Fresco']","['blood samples', 'prevalence of NAFLD', 'median NAFLD liver fat score']","[{'cui': 'C0562518', 'cui_str': 'Village environment'}, {'cui': 'C0018367', 'cui_str': 'Guatemala'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0449820', 'cui_str': 'Score'}]","[{'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0556077', 'cui_str': 'Energy supplementation'}, {'cui': 'C0086153', 'cui_str': 'Diet Modification'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0001967', 'cui_str': 'Alcoholic beverage'}]","[{'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0835527,"The median NAFLD liver fat score was 0.2 (IQR: -1.2, 1.6) in women and -1.2 (IQR: -2.2, 0.5) in men (p<0.0001).","[{'ForeName': 'Ahlia', 'Initials': 'A', 'LastName': 'Sekkarie', 'Affiliation': 'Nutrition and Health Sciences Program, Laney Graduate School, Emory University, Atlanta, GA, United States. Electronic address: asekkar@emory.edu.'}, {'ForeName': 'Siran', 'Initials': 'S', 'LastName': 'He', 'Affiliation': 'Nutrition and Health Sciences Program, Laney Graduate School, Emory University, Atlanta, GA, United States.'}, {'ForeName': 'Jean A', 'Initials': 'JA', 'LastName': 'Welsh', 'Affiliation': 'Department of Pediatrics, Emory School of Medicine, Atlanta, GA, United States.'}, {'ForeName': 'Usha', 'Initials': 'U', 'LastName': 'Ramakrishnan', 'Affiliation': 'Nutrition and Health Sciences Program, Laney Graduate School, Emory University, Atlanta, GA, United States; Hubert Department of Global Health, Rollins School of Public Health, Emory University, Atlanta, GA, United States.'}, {'ForeName': 'Aryeh D', 'Initials': 'AD', 'LastName': 'Stein', 'Affiliation': 'Hubert Department of Global Health, Rollins School of Public Health, Emory University, Atlanta, GA, United States.'}, {'ForeName': 'Miriam B', 'Initials': 'MB', 'LastName': 'Vos', 'Affiliation': 'Department of Pediatrics, Emory School of Medicine, Atlanta, GA, United States.'}]",Annals of hepatology,['10.1016/j.aohep.2020.04.004'] 1684,32512364,Intake of Camelina Sativa Oil and Fatty Fish Alter the Plasma Lipid Mediator Profile in Subjects with Impaired Glucose Metabolism - A Randomized Controlled Trial.,"n-3 and n-6 polyunsaturated fatty acids (PUFAs) and their lipid mediator metabolites are associated with inflammation. We investigated the effect of dietary intake of plant- and animal-derived n-3 PUFAs and fish protein on the circulatory concentrations of lipid mediators. Seventy-nine subjects with impaired fasting glucose who completed the controlled dietary intervention after randomization to the fatty fish (FF, n=20), lean fish (LF, n=21), Camelina sativa oil (CSO, n=18) or control group (n=20) for 12 weeks were studied. Lipid mediator profiling from fasting plasma samples before and after the intervention was performed by liquid chromatography-mass spectrometry (LC-MS/MS). The FF diet increased concentrations of 18-hydroxyeicosapentaenoic acid (18-HEPE) and 4- and 17-hydroxydocosahexaenoic acid (4-, 17-HDoHE) derived from eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), respectively. Concentrations of lipid mediators derived from α-linolenic acid (ALA) increased and arachidonic acid (AA) derived 5-iso prostaglandin F 2α -VI decreased in the CSO group. There were no significant changes in lipid mediators in the LF group. The dietary intake of both plant and animal-based n-3 PUFAs increased circulatory concentrations of lipid mediators with potential anti-inflammatory properties.",2020,The FF diet increased concentrations of 18-hydroxyeicosapentaenoic acid (18-HEPE) and,"['Subjects with Impaired Glucose Metabolism ', 'Seventy-nine subjects with impaired fasting glucose who completed the controlled dietary intervention after randomization to the fatty fish (FF, n=20), lean fish (LF, n=21']","['plant- and animal-derived n-3 PUFAs and fish protein', 'Camelina sativa oil (CSO, n=18) or control group', 'Camelina Sativa Oil and Fatty Fish', 'n-3 and n-6 polyunsaturated fatty acids (PUFAs', 'plant and animal-based n-3 PUFAs', '4- and 17-hydroxydocosahexaenoic acid (4-, 17-HDoHE) derived from eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA']","['lipid mediators', 'arachidonic acid (AA) derived 5-iso prostaglandin F 2α -VI', 'concentrations of 18-hydroxyeicosapentaenoic acid (18-HEPE', 'Plasma Lipid Mediator Profile']","[{'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0086153', 'cui_str': 'Diet Modification'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0453017', 'cui_str': 'Fatty fish'}, {'cui': 'C0016163', 'cui_str': 'Fish'}]","[{'cui': 'C0032098', 'cui_str': 'Kingdom Viridiplantae'}, {'cui': 'C0003062', 'cui_str': 'Kingdom Animalia'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0598294', 'cui_str': 'Fish Proteins'}, {'cui': 'C0028908', 'cui_str': 'Oil'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0453017', 'cui_str': 'Fatty fish'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0639949', 'cui_str': '17-hydroxy-4,7,10,13,15,19-docosahexaenoic acid'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic acid'}, {'cui': 'C0012968', 'cui_str': 'Docosahexenoic Acids'}, {'cui': 'C0142831', 'cui_str': 'sodium dehydroacetate'}]","[{'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0003695', 'cui_str': 'Arachidonic acid'}, {'cui': 'C0911936', 'cui_str': 'isovaleronitrile'}, {'cui': 'C0033561', 'cui_str': 'F series prostaglandin'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C3251952', 'cui_str': '18(R)-hydroxyeicosapentaenoic acid'}, {'cui': 'C0019215', 'cui_str': ""N-2-Hydroxyethylpiperazine-N'-2'-ethanesulfonic Acid""}, {'cui': 'C1278073', 'cui_str': 'Plasma lipid measurement'}]",79.0,0.053379,The FF diet increased concentrations of 18-hydroxyeicosapentaenoic acid (18-HEPE) and,"[{'ForeName': 'Topi', 'Initials': 'T', 'LastName': 'Meuronen', 'Affiliation': 'Institute of Public Health and Clinical Nutrition, School of Medicine, University of Eastern Finland, 70211 Kuopio, Finland. Electronic address: topim@uef.fi.'}, {'ForeName': 'Maria A', 'Initials': 'MA', 'LastName': 'Lankinen', 'Affiliation': 'Institute of Public Health and Clinical Nutrition, School of Medicine, University of Eastern Finland, 70211 Kuopio, Finland.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Fauland', 'Affiliation': 'Division of Physiological Chemistry 2, Department of Medical Biochemistry and Biophysics, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Bun-Ichi', 'Initials': 'BI', 'LastName': 'Shimizu', 'Affiliation': 'Division of Physiological Chemistry 2, Department of Medical Biochemistry and Biophysics, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Vanessa D', 'Initials': 'VD', 'LastName': 'de Mello', 'Affiliation': 'Institute of Public Health and Clinical Nutrition, School of Medicine, University of Eastern Finland, 70211 Kuopio, Finland.'}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'Laaksonen', 'Affiliation': 'Department of Medicine, Endocrinology and Clinical Nutrition, Kuopio University Hospital, 70029 Kuopio University Hospital, Finland; Institute of Biomedicine, Physiology, University of Eastern Finland, 70211 Kuopio, Finland.'}, {'ForeName': 'Craig E', 'Initials': 'CE', 'LastName': 'Wheelock', 'Affiliation': 'Division of Physiological Chemistry 2, Department of Medical Biochemistry and Biophysics, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Arja T', 'Initials': 'AT', 'LastName': 'Erkkilä', 'Affiliation': 'Institute of Public Health and Clinical Nutrition, School of Medicine, University of Eastern Finland, 70211 Kuopio, Finland.'}, {'ForeName': 'Ursula S', 'Initials': 'US', 'LastName': 'Schwab', 'Affiliation': 'Institute of Public Health and Clinical Nutrition, School of Medicine, University of Eastern Finland, 70211 Kuopio, Finland; Department of Medicine, Endocrinology and Clinical Nutrition, Kuopio University Hospital, 70029 Kuopio University Hospital, Finland.'}]","Prostaglandins, leukotrienes, and essential fatty acids",['10.1016/j.plefa.2020.102143'] 1685,32512477,"Effect of a maximal exercise test on serum and urinary concentrations of magnesium, phosphorous, rubidium and strontium in athletes.","AIM This study aims to determine the changes induced by a maximal exercise test until exhaustion on the serum and urinary concentrations of Magnesium (Mg), Phosphorous (P), Rubidium (Rb) and Strontium (Sr) in athletes (AG) and sedentary students (SG). METHODS Fifty subjects participated in the study divided into two groups. In AG there were twenty-five male athletes and in SG there were twenty-five male sedentary students. Both groups performed an exercise test until exhaustion, starting at 8 or 10 km/h respectively, and increasing the speed at 1 km/h every 400 m. Serum and urine samples were obtained from all participants before and after the test. RESULTS Regarding the basal status, AG showed lower values of Mg in serum (p < 0.05) and urine (p < 0.01), but higher concentrations of serum P (p < 0.05) in comparison to SG. Comparing the pre and post-test values, corrected or non-corrected for hemoconcentration in serum and for creatinine in urine, AG showed a decrease in serum Mg (p < 0.05), in serum P (p < 0.01) and in urinary Sr (p < 0.01) while an increase was observed in urinary P (p < 0.05) and in urinary Rb (p < 0.05). CONCLUSIONS It can be concluded that a treadmill test until exhaustion leads to changes in serum and urinary concentrations of minerals in both AG and SG males. This may reflect an adaptive response of the body to overcome the physical stress and, in some cases, to avoid loss of these elements.",2020,"Regarding the basal status, AG showed lower values of Mg in serum (p < 0.05) and urine (p < 0.01), but higher concentrations of serum P (p < 0.05) in comparison to SG.","['athletes', 'athletes (AG) and sedentary students (SG', 'In AG there were twenty-five male athletes and in SG there were twenty-five male sedentary students', 'Fifty subjects participated in the study divided into two groups']",['maximal exercise test'],"['urinary Rb', 'serum and urinary concentrations of Magnesium (Mg), Phosphorous (P), Rubidium (Rb) and Strontium (Sr', 'urinary Sr', 'serum and urinary concentrations of magnesium, phosphorous, rubidium and strontium']","[{'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}]","[{'cui': 'C0035930', 'cui_str': 'Rubidium'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0232827', 'cui_str': 'Urinary concentration'}, {'cui': 'C0024467', 'cui_str': 'Magnesium'}, {'cui': 'C0031705', 'cui_str': 'Phosphorus'}, {'cui': 'C0038467', 'cui_str': 'Strontium'}]",25.0,0.0207851,"Regarding the basal status, AG showed lower values of Mg in serum (p < 0.05) and urine (p < 0.01), but higher concentrations of serum P (p < 0.05) in comparison to SG.","[{'ForeName': 'Diego', 'Initials': 'D', 'LastName': 'Muñoz', 'Affiliation': 'Exercise Physiology Lab, Sport Sciences Faculty, University of Extremadura, Avenida De La Universidad s/n, 10003, Cáceres, Spain. Electronic address: diegomun@unex.es.'}, {'ForeName': 'Francisco J', 'Initials': 'FJ', 'LastName': 'Grijota', 'Affiliation': 'Exercise Physiology Lab, Sport Sciences Faculty, University of Extremadura, Avenida De La Universidad s/n, 10003, Cáceres, Spain. Electronic address: fgrijota@gmail.com.'}, {'ForeName': 'Jesús', 'Initials': 'J', 'LastName': 'Siquier-Coll', 'Affiliation': 'Exercise Physiology Lab, Sport Sciences Faculty, University of Extremadura, Avenida De La Universidad s/n, 10003, Cáceres, Spain. Electronic address: jsiquier@alumnos.unex.es.'}, {'ForeName': 'Víctor', 'Initials': 'V', 'LastName': 'Toro-Román', 'Affiliation': 'Exercise Physiology Lab, Sport Sciences Faculty, University of Extremadura, Avenida De La Universidad s/n, 10003, Cáceres, Spain. Electronic address: vtororom@alumnos.unex.es.'}, {'ForeName': 'Ignacio', 'Initials': 'I', 'LastName': 'Bartolomé', 'Affiliation': 'Exercise Physiology Lab, Sport Sciences Faculty, University of Extremadura, Avenida De La Universidad s/n, 10003, Cáceres, Spain. Electronic address: ignbs.1991@gmail.com.'}, {'ForeName': 'Marcos', 'Initials': 'M', 'LastName': 'Maynar-Mariño', 'Affiliation': 'Exercise Physiology Lab, Sport Sciences Faculty, University of Extremadura, Avenida De La Universidad s/n, 10003, Cáceres, Spain. Electronic address: mmaynar@unex.es.'}]",Journal of trace elements in medicine and biology : organ of the Society for Minerals and Trace Elements (GMS),['10.1016/j.jtemb.2020.126572'] 1686,32513231,Treatment with Hydroxychloroquine vs Hydroxychloroquine + Nitazoxanide in COVID-19 patients with risk factors for poor prognosis: A structured summary of a study protocol for a randomised controlled trial.,"OBJECTIVES To determine the efficacy of Hydroxychloroquine vs. Hydroxychloroquine + Nitazoxanide in reducing the need for invasive mechanical ventilatory support for patients with COVID-19. Hydroxychloroquine is currently being used in multiple trials with varying doses in an attempt to treat COVID-19. Nitazoxanide has powerful antiviral effects and proven efficacy against a range of viruses including SARS and MERS. Dual therapy by combining appropriate doses of these two medications with diverse activities against COVID-19 is expected to be better than monotherapy with hydroxychloroquine. TRIAL DESIGN This is a single centre, randomized, controlled, single blinded, 2 arm (ratio 1:1) parallel group trial. PARTICIPANTS 86 COVID-19 positive patients that are being treated at the Health Institute of the State of Mexico (ISEM) in Toluca, State of Mexico will be recruited from May 14 to December 31, 2020. INCLUSION CRITERIA 1)Age older than 18 years.2)Hospitalised COVID-19 PCR test positive patients.3)Within the first 72 hours after performing the PCR test.4)Presence of risk factors for complications (at least one): over 60 years, history of diabetes mellitus, hypertension, and morbid obesity. EXCLUSION CRITERIA 1)Patients with corrected QT interval (QTc) greater than 500ms at hospital admission.2)Patients who have inherent contraindications to each drug.3)Patients who are unable to consent.4)Patients who have previously received chloroquine.5)Patients already intubated. Elimination criteria: 1)Patients whose clinical follow-up is lost or who decide not to continue in the study INTERVENTION AND COMPARATOR: The two management alternatives will be: Control - Hydroxychloroquine 200 mg taken orally every 12 hours for 7 days. Dual therapy - Hydroxychloroquine 400 mg taken orally every 12 hours for two days and then 200 mg taken orally every 12 hours for four days + Nitazoxanide 500 mg orally every 6 hours taken with food, for seven days. MAIN OUTCOMES Primary: Mechanical ventilation requirement assessed at one week. Percentage of COVID-19 positive patients who require mechanical ventilation . All patients will be monitored till hospital discharge or death. RANDOMISATION Patients will be randomly allocated using allocation papers and opaque sealed envelopes to either receive the placebo or the dual therapy intervention treatment in a 1:1 ratio until we have recruited the required number of patients for each group. BLINDING (MASKING) Trial participants will be blinded. NUMBERS TO BE RANDOMISED (SAMPLE SIZE) 86 participants will be randomized to each group, with 43 in the control group and 43 in the dual therapy group. TRIAL STATUS Protocol version: 2, recruitment will begin on May 14 until sample size is reached , with the analysis deadline of December 31st 2020. TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT04341493. Date of trial registration: April 10, 2020 FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest of expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.",2020,Nitazoxanide has powerful antiviral effects and proven efficacy against a range of viruses including SARS and MERS.,"['patients with COVID-19', 'COVID-19 patients with risk factors for poor prognosis', '1)Patients with corrected QT interval (QTc) greater than 500ms at hospital admission.2)Patients who have inherent contraindications to each drug.3)Patients who are unable to consent.4)Patients who have previously received chloroquine.5)Patients already intubated', '86 COVID-19 positive patients that are being treated at the Health Institute of the State of Mexico (ISEM) in Toluca, State of Mexico will be recruited from May 14 to December 31, 2020', '86 participants will be randomized to each group, with 43 in the control group and 43 in the dual therapy group']","['Nitazoxanide', 'Hydroxychloroquine vs Hydroxychloroquine + Nitazoxanide', 'hydroxychloroquine', 'Hydroxychloroquine', 'Control - Hydroxychloroquine', 'Dual therapy - Hydroxychloroquine', 'placebo or the dual therapy intervention treatment', 'Hydroxychloroquine vs. Hydroxychloroquine + Nitazoxanide']",['hospital discharge or death'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0278252', 'cui_str': 'Prognosis bad'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0429028', 'cui_str': 'QT interval feature'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0522473', 'cui_str': 'Contraindication to'}, {'cui': 'C0566415', 'cui_str': 'Unable to feed self'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0025885', 'cui_str': 'Mexico'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C1527374', 'cui_str': 'Group Therapy'}]","[{'cui': 'C0068788', 'cui_str': 'nitazoxanide'}, {'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0586003', 'cui_str': 'Discharge from hospital'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",86.0,0.38205,Nitazoxanide has powerful antiviral effects and proven efficacy against a range of viruses including SARS and MERS.,"[{'ForeName': 'José Meneses', 'Initials': 'JM', 'LastName': 'Calderón', 'Affiliation': 'Internal Medicine, Intensive Care Unit, ""Lic. Adolfo López Mateos"" General Hospital, Toluca, Mexico.'}, {'ForeName': 'Hugo Mendieta', 'Initials': 'HM', 'LastName': 'Zerón', 'Affiliation': 'Autonomous University of the State of Mexico (UAEMex), Internal Medicine and Medical Sciences (UNAM), Endocrinology, University of Santiago de Compostela, Santiago de Compostela, Spain. hmendietaz@uaemex.mx.'}, {'ForeName': 'Srivatsan', 'Initials': 'S', 'LastName': 'Padmanabhan', 'Affiliation': 'Internal Medicine, St. Joseph Medical Center, Tacoma, WA, USA.'}]",Trials,['10.1186/s13063-020-04448-2'] 1687,32513936,Investigating resting brain perfusion abnormalities and disease target-engagement by intranasal oxytocin in women with bulimia nervosa and binge-eating disorder and healthy controls.,"Advances in the treatment of bulimia nervosa and binge-eating disorder (BN/BED) have been marred by our limited understanding of the underpinning neurobiology. Here we measured regional cerebral blood flow (rCBF) to map resting perfusion abnormalities in women with BN/BED compared with healthy controls and investigate whether intranasal oxytocin (OT), proposed as a potential treatment, can restore perfusion in disorder-related brain circuits. Twenty-four women with BN/BED and 23 healthy women participated in a randomized, double-blind, crossover, placebo-controlled study. We used arterial spin labelling MRI to measure rCBF and the effects of an acute dose of intranasal OT (40 IU) or placebo over 18-26 min post dosing, as we have previously shown robust OT-induced changes in resting rCBF in men in a similar time-window (15-36 min post dosing). We tested for effects of treatment, diagnosis and their interaction on extracted rCBF values in anatomical regions-of-interest previously implicated in BN/BED by other neuroimaging modalities, and conducted exploratory whole-brain analyses to investigate previously unidentified brain regions. We demonstrated that women with BN/BED presented increased resting rCBF in the medial prefrontal and orbitofrontal cortices, anterior cingulate gyrus, posterior insula and middle/inferior temporal gyri bilaterally. Hyperperfusion in these areas specifically correlated with eating symptoms severity in patients. Our data did not support a normalizing effect of intranasal OT on perfusion abnormalities in these patients, at least for the specific dose (40 IU) and post-dosing interval (18-26 min) examined. Our findings enhance our understanding of resting brain abnormalities in BN/BED and identify resting rCBF as a non-invasive potential biomarker for disease-related changes and treatment monitoring. They also highlight the need for a comprehensive investigation of intranasal OT pharmacodynamics in women before we can fully ascertain its therapeutic value in disorders affecting predominantly this gender, such as BN/BED.",2020,"We demonstrated that women with BN/BED presented increased resting rCBF in the medial prefrontal and orbitofrontal cortices, anterior cingulate gyrus, posterior insula and middle/inferior temporal gyri bilaterally.","['Twenty-four women with BN/BED and 23 healthy women', 'women with BN/BED compared with healthy controls', 'bulimia nervosa and binge-eating disorder (BN/BED', 'women with bulimia nervosa and binge-eating disorder and healthy controls']","['intranasal OT', 'intranasal oxytocin (OT', 'intranasal oxytocin', 'placebo']","['perfusion abnormalities', 'medial prefrontal and orbitofrontal cortices, anterior cingulate gyrus, posterior insula and middle/inferior temporal gyri bilaterally', 'resting rCBF', 'regional cerebral blood flow (rCBF', 'eating symptoms severity']","[{'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C2267227', 'cui_str': 'Bulimia nervosa'}, {'cui': 'C0596170', 'cui_str': 'Binge eating disorder'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0000768', 'cui_str': 'Congenital malformation'}, {'cui': 'C0205098', 'cui_str': 'Medial'}, {'cui': 'C0152301', 'cui_str': 'Structure of orbital gyrus'}, {'cui': 'C0018427', 'cui_str': 'Structure of cingulate gyrus'}, {'cui': 'C0228261', 'cui_str': 'Structure of long insular gyrus'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0442043', 'cui_str': 'Temporal'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0007818', 'cui_str': 'Circulation, Cerebrovascular'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}]",24.0,0.231848,"We demonstrated that women with BN/BED presented increased resting rCBF in the medial prefrontal and orbitofrontal cortices, anterior cingulate gyrus, posterior insula and middle/inferior temporal gyri bilaterally.","[{'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Martins', 'Affiliation': ""Department of Neuroimaging, Institute of Psychiatry, Psychology and Neuroscience, King's College London, De Crespigny Park, London, SE5 8AF, UK.""}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Leslie', 'Affiliation': ""Section of Eating Disorders, Institute of Psychiatry, Psychology and Neuroscience, King's College London, De Crespigny Park, London, SE5 8AF, UK.""}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Rodan', 'Affiliation': ""Department of Neuroimaging, Institute of Psychiatry, Psychology and Neuroscience, King's College London, De Crespigny Park, London, SE5 8AF, UK.""}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Zelaya', 'Affiliation': ""Department of Neuroimaging, Institute of Psychiatry, Psychology and Neuroscience, King's College London, De Crespigny Park, London, SE5 8AF, UK.""}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Treasure', 'Affiliation': ""Section of Eating Disorders, Institute of Psychiatry, Psychology and Neuroscience, King's College London, De Crespigny Park, London, SE5 8AF, UK.""}, {'ForeName': 'Yannis', 'Initials': 'Y', 'LastName': 'Paloyelis', 'Affiliation': ""Department of Neuroimaging, Institute of Psychiatry, Psychology and Neuroscience, King's College London, De Crespigny Park, London, SE5 8AF, UK. yannis.paloyelis@kcl.ac.uk.""}]",Translational psychiatry,['10.1038/s41398-020-00871-w'] 1688,32511114,Comparing the Efficacy of Resuscitation Educational Modalities: A Randomized Study.,"This study evaluated the efficacy of online versus instructor-led advanced cardiac life support for first-time registered nurse participants. Participants were randomized into online or instructor-led courses, with learning outcomes measured in the cognitive, psychomotor, and affective domains. The instructor-led group showed statistically significant better performance during simulated megacode. Further analysis identified key areas where instructor-led participants out-performed the online group, enabling educators to articulate risk and benefit of the two learning modalities.",2020,The instructor-led group showed statistically significant better performance during simulated megacode.,['first-time registered nurse participants'],"['Resuscitation Educational Modalities', 'online versus instructor-led advanced cardiac life support']",[],"[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0687673', 'cui_str': 'Registered nurse'}]","[{'cui': 'C0035273', 'cui_str': 'Resuscitation'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0887907', 'cui_str': 'Advanced cardiac life support'}]",[],,0.0524608,The instructor-led group showed statistically significant better performance during simulated megacode.,"[{'ForeName': 'Mandi D', 'Initials': 'MD', 'LastName': 'Walker', 'Affiliation': 'Mandi D. Walker, DNP, RN, CCRN-K, NPD-BC, NEA-BC, is System Executive Director of Professional Practice, University of Louisville Health, Kentucky. Bridget Nuxoll, MSN, RN, PCCN-K, NPD-BC, is Professional Development Coordinator, University of Louisville Health, Kentucky. Sherle Niner, MSN, RN-BC, is Ancillary Staff Educator, University of Louisville Hospital, Kentucky. Thomas L. Hagan, MSN, RN, CCRN-K, NPD-BC, is Resuscitation and Simulation Educator, Robley Rex Veterans Affairs Medical Center, Louisville, Kentucky.'}, {'ForeName': 'Bridget', 'Initials': 'B', 'LastName': 'Nuxoll', 'Affiliation': ''}, {'ForeName': 'Sherle', 'Initials': 'S', 'LastName': 'Niner', 'Affiliation': ''}, {'ForeName': 'Thomas L', 'Initials': 'TL', 'LastName': 'Hagan', 'Affiliation': ''}]",Journal for nurses in professional development,['10.1097/NND.0000000000000645'] 1689,31996717,Gut microbiota plasticity is correlated with sustained weight loss on a low-carb or low-fat dietary intervention.,"While low-carbohydrate and low-fat diets can both lead to weight-loss, a substantial variability in achieved long-term outcomes exists among obese but otherwise healthy adults. We examined the hypothesis that structural differences in the gut microbiota explain a portion of variability in weight-loss using two cohorts of obese adults enrolled in the Diet Intervention Examining The Factors Interacting with Treatment Success (DIETFITS) study. A total of 161 pre-diet fecal samples were sequenced from a discovery cohort (n = 66) and 106 from a validation cohort (n = 56). An additional 157 fecal samples were sequenced from the discovery cohort after 10 weeks of dietary intervention. We found no specific bacterial signatures associated with weight loss that were consistent across both cohorts. However, the gut microbiota plasticity (i.e. variability), was correlated with long-term (12-month) weight loss in a diet-dependent manner; on the low-fat diet subjects with higher pre-diet daily plasticity had higher sustained weight loss, whereas on the low-carbohydrate diet those with higher plasticity over 10 weeks of dieting had higher 12-month weight loss. Our findings suggest the potential importance of gut microbiota plasticity for sustained weight-loss. We highlight the advantages of evaluating kinetic trends and assessing reproducibility in studies of the gut microbiota.",2020,We found no specific bacterial signatures associated with weight loss that were consistent across both cohorts.,"['A total of 161 pre-diet fecal samples were sequenced from a discovery cohort (n = 66) and 106 from a validation cohort (n = 56', 'obese but otherwise healthy adults']",['Diet Intervention Examining'],"['weight loss', 'sustained weight loss', 'long-term (12-month) weight loss', 'gut microbiota plasticity']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0004793', 'cui_str': 'Base sequence'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C0678558', 'cui_str': 'Plasticity'}]",161.0,0.0139624,We found no specific bacterial signatures associated with weight loss that were consistent across both cohorts.,"[{'ForeName': 'Jessica A', 'Initials': 'JA', 'LastName': 'Grembi', 'Affiliation': 'Department of Civil and Environmental Engineering, Stanford University, 318 Campus Drive E250 Clark Center, Stanford, CA, 94305, United States. jgrembi@stanford.edu.'}, {'ForeName': 'Lan H', 'Initials': 'LH', 'LastName': 'Nguyen', 'Affiliation': 'Institute for Computational and Mathematical Engineering, Stanford University, 475 Via Ortega, Stanford, CA, 94305, United States.'}, {'ForeName': 'Thomas D', 'Initials': 'TD', 'LastName': 'Haggerty', 'Affiliation': 'Department of Medicine, Stanford University School of Medicine, 291 Campus Drive, Stanford, CA, 94305, United States.'}, {'ForeName': 'Christopher D', 'Initials': 'CD', 'LastName': 'Gardner', 'Affiliation': 'Stanford Prevention Research Center, Department of Medicine, Stanford University School of Medicine, 1265 Welch Road, Stanford, CA, 94305, United States.'}, {'ForeName': 'Susan P', 'Initials': 'SP', 'LastName': 'Holmes', 'Affiliation': 'Department of Statistics, Stanford University, 390 Serra Mall, Stanford, CA, 94305, United States.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Parsonnet', 'Affiliation': 'Department of Medicine, Stanford University School of Medicine, 291 Campus Drive, Stanford, CA, 94305, United States.'}]",Scientific reports,['10.1038/s41598-020-58000-y'] 1690,32516507,Influence of hand and rotary files for endodontic treatment of primary teeth on immediate outcomes: Secondary analysis of a randomized controlled trial.,"BACKGROUND Endodontic treatment of primary teeth can be time-consuming. AIM To compare hand and rotary files regarding the time for root canal chemical-mechanical preparation, child's behavior, apical limit of the obturation, and post-operative pain. DESIGN This secondary data from a randomized clinical trial with two parallel arms evaluated endodontic instrumentation in 88 children aged 4-9 years. Stratified and block randomization was performed into two groups: K-file hand and ProDesign Logic rotary files. The evaluated outcomes were the chemical-mechanical preparation time, child's behavior using the Frankl scale, apical limit of the obturation, and post-operative pain using the Faces Pain Scale-Revised. One operator and all outcome appraisers were blinded to the chemical-mechanical technique. Multiple linear regression, chi-square, and Fisher's exact test were performed. RESULTS The mean time for chemical-mechanical preparation using hand files was 24.5 (SD 4.0) minutes, and using rotary files, it was 17.0 (SD 2.5) minutes (P < .001). No difference was found between the instrumentation methods in the child's behavior, apical limit of the obturation, or post-operative pain. CONCLUSIONS The ProDesign Logic file reduced the average procedure time but presented no difference in the other variables studied when compared to the K-file.",2020,"No difference was found between the instrumentation methods in the child's behavior, apical limit of the obturation, or postoperative pain. ",['88 children aged four to nine years'],[],"[""child's behavior, apical limit of the obturation, or postoperative pain"", 'mean time for chemical-mechanical preparation', ""chemical-mechanical preparation time, child's behavior using the Frankl scale, apical limit of the obturation, and postoperative pain using the Faces Pain Scale-Revised""]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]",[],"[{'cui': 'C0008065', 'cui_str': 'Behavior, Child'}, {'cui': 'C0205111', 'cui_str': 'Apical'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0220806', 'cui_str': 'Chemical'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0015468', 'cui_str': 'Pain in face'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}]",88.0,0.124704,"No difference was found between the instrumentation methods in the child's behavior, apical limit of the obturation, or postoperative pain. ","[{'ForeName': 'Jéssica C', 'Initials': 'JC', 'LastName': 'Barasuol', 'Affiliation': 'Department of Dentistry, Universidade Federal de Santa Catarina, Florianópolis, Brazil.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Massignan', 'Affiliation': 'Department of Dentistry, Universidade Federal de Santa Catarina, Florianópolis, Brazil.'}, {'ForeName': 'Eduardo A', 'Initials': 'EA', 'LastName': 'Bortoluzzi', 'Affiliation': 'Department of Dentistry, Universidade Federal de Santa Catarina, Florianópolis, Brazil.'}, {'ForeName': 'Mariane', 'Initials': 'M', 'LastName': 'Cardoso', 'Affiliation': 'Department of Dentistry, Universidade Federal de Santa Catarina, Florianópolis, Brazil.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Bolan', 'Affiliation': 'Department of Dentistry, Universidade Federal de Santa Catarina, Florianópolis, Brazil.'}]",International journal of paediatric dentistry,['10.1111/ipd.12682'] 1691,32516744,Evaluation of factors influencing obesity and the effect of a 12-week home-based exercise program in people with epilepsy - Randomized control trial.,"BACKGROUND Association of obesity, quality of life (QoL), and physical fitness in people with epilepsy (PWE) is rarely reported. We evaluate the effect of a 12-week home-based exercise program on weight reduction and physical capacity in PWE. METHODS In 173 PWE, physical fitness was assessed by using six-minute walk test (6MWT) and one-minute step test. Self-reported QoL data was collected using a 12-Item Short Form Survey (SF-12) questionnaire; further physical (PCS) and mental (MCS) component scores were derived. Effect of exercise was evaluated using randomized study of 110 PWE, divided into control and exercise groups of 55 each. RESULTS At baseline, mean age of study population was 25.85 ± 9.62 years with 77 (44.5%) women. Average body mass index (BMI) was 29.33 ± 6.17 kg/m 2 . Mean PCS and MCS were 45.95 ± 7.92 and 45.72 ± 10.40 respectively. In 124 (71.7%) PWE with obesity, while high-density lipoprotein (HDL-C) (46.10 ± 12.32 vs. 39.30 ± 10.39 mg/dL; p < .001) was lower, low-density lipoprotein (LDL-C) (101.60 ± 37.51 vs. 113.89 ± 32.65 mg/dL; p = .035) was high. Both the randomized groups were comparable for type and number of antiepileptic drugs (AEDs) used. At 12-week follow-up, PWE in the exercise group reduced 7.65 ± 5.62 kg while control group gained an average of 4.01 ± 4.74 kg (p < .001). Distance walked in 6MWT (293.07 ± 118.73 vs. 464.29 ± 55.33 m; p = .007) and PCS (48.59 ± 8.57 vs. 52.62 ± 4.03; p = .006) were higher in exercise group whereas MCS did not differ between the groups. None of the participants reported seizure during the 12-week follow-up period. CONCLUSION People with epilepsy have low PCS and MCS scores; PWE with obesity have altered metabolic profile when compared to PWE without obesity. A 12-week, home-based exercise program significantly reduces weight and improves physical capacity, irrespective of AEDs used. Trials with larger sample size and longer follow-up are required to validate our findings.",2020,"A 12-week, home-based exercise program significantly reduces weight and improves physical capacity, irrespective of AEDs used.","['110 PWE, divided into control and exercise groups of 55 each', 'people with epilepsy - Randomized control trial', 'At baseline, mean age of study population was 25.85\u202f±\u202f9.62\u202fyears with 77 (44.5%) women', 'people with epilepsy (PWE']",['home-based exercise program'],"['12-Item Short Form Survey (SF-12) questionnaire; further physical (PCS) and mental (MCS) component scores', 'Average body mass index (BMI', 'physical fitness', 'Distance walked in 6MWT', 'weight and improves physical capacity', 'weight reduction and physical capacity', 'Mean PCS and MCS', 'low-density lipoprotein (LDL-C']","[{'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0014544', 'cui_str': 'Epilepsy'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1276393', 'cui_str': 'Group exercise'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1882368', 'cui_str': 'Dynamic Light Scattering'}, {'cui': 'C0036221', 'cui_str': 'Mast cell sarcoma'}, {'cui': 'C0023823', 'cui_str': 'Low density lipoprotein'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}]",,0.0800908,"A 12-week, home-based exercise program significantly reduces weight and improves physical capacity, irrespective of AEDs used.","[{'ForeName': '', 'Initials': '', 'LastName': 'SudhindraVooturi', 'Affiliation': 'Department of Neurology, Krishna Institute of Medical Sciences, Secunderabad, Telangana, India. Electronic address: sudhindragupta@gmail.com.'}, {'ForeName': 'A N R', 'Initials': 'ANR', 'LastName': 'Lakshmi', 'Affiliation': 'Department of Physiology, Chalmeda Anand Rao Institute of Medical Sciences, Karimnagar, Telangana, India.'}, {'ForeName': 'Sita', 'Initials': 'S', 'LastName': 'Jayalakshmi', 'Affiliation': 'Department of Neurology, Krishna Institute of Medical Sciences, Secunderabad, Telangana, India.'}]",Epilepsy & behavior : E&B,['10.1016/j.yebeh.2020.107148'] 1692,32521284,The effect of vibration therapy on neck myofascial trigger points: A randomized controlled pilot study.,"BACKGROUND The purpose of this study was to evaluate the effect of low-frequency self-administered vibration therapy into myofascial trigger points in the upper trapezius and levator scapulae on patients with chronic non-specific neck pain. METHODS Twenty-eight patients with chronic non-specific neck pain were randomly assigned into a vibration group, receiving 10 self-applied sessions of vibration therapy in the upper trapezius and levator scapulae trigger points; or a control group, receiving no intervention. Self-reported neck pain and disability (Neck Disability Index) and pressure pain threshold were assessed at baseline and after the first, fifth and 10th treatment sessions. FINDINGS Significant differences were found in the vibration group when compared to the control group after the treatment period: the vibration group reached lower Neck Disability Index scores (F = 4.74, P = .033, η 2  = 0.07) and greater pressure pain threshold values (F = 7.56, P = .01, η 2  = 0.10) than the control group. The vibration group reported a significant reduction in Neck Disability Index scores (χ2 = 19,35, P = .00, Kendall's W = 0.28) and an increase in pressure pain threshold (χ2 = 87,10, P = .00, Kendall's W = 0.73) between the assessment times over the course of the treatment. The mean increase in pressure pain threshold in the vibration group after the 10 sessions was 8.54 N/cm2, while the mean reduction in Neck Disability Index scores was 4.53 points. INTERPRETATION Vibration therapy may be an effective intervention for reducing self-reported neck pain and disability and pressure pain sensitivity in patients with chronic non-specific neck pain. This tool could be recommended for people with non-specific neck pain.",2020,"INTERPRETATION Vibration therapy may be an effective intervention for reducing self-reported neck pain and disability and pressure pain sensitivity in patients with chronic non-specific neck pain.","['people with non-specific neck pain', 'patients with chronic non-specific neck pain', 'Twenty-eight patients with chronic non-specific neck pain']","['low-frequency self-administered vibration therapy', 'vibration group, receiving 10 self-applied sessions of vibration therapy in the upper trapezius and levator scapulae trigger points; or a control group, receiving no intervention', 'vibration therapy']","['Neck Disability Index scores', 'Self-reported neck pain and disability (Neck Disability Index) and pressure pain threshold', 'pressure pain threshold', 'neck myofascial trigger points', 'pressure pain threshold values']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205370', 'cui_str': 'Non-specific'}, {'cui': 'C0007859', 'cui_str': 'Neck pain'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C4283787', 'cui_str': '28'}]","[{'cui': 'C0205213', 'cui_str': 'Low frequency'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0455941', 'cui_str': 'Vibration - treatment'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0224361', 'cui_str': 'Structure of trapezius muscle'}, {'cui': 'C0224368', 'cui_str': 'Structure of levator scapulae muscle'}, {'cui': 'C0458343', 'cui_str': 'Trigger point'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C2959538', 'cui_str': 'Neck disability index score'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0007859', 'cui_str': 'Neck pain'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C0458343', 'cui_str': 'Trigger point'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",28.0,0.0224475,"INTERPRETATION Vibration therapy may be an effective intervention for reducing self-reported neck pain and disability and pressure pain sensitivity in patients with chronic non-specific neck pain.","[{'ForeName': 'L', 'Initials': 'L', 'LastName': 'Dueñas', 'Affiliation': 'Department of Physical Therapy, University of Valencia, Gascó Oliag 5, 46010, Valencia, Spain. Electronic address: lirios.duenas@uv.es.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Zamora', 'Affiliation': 'European Sleep Care Institute, San Vicente 16, 46023, Valencia, Spain. Electronic address: innovation@escinstitute.com.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Lluch', 'Affiliation': 'Department of Physical Therapy, University of Valencia, Gascó Oliag 5, 46010, Valencia, Spain; ""Pain in Motion"" international research group, Belgium. Electronic address: enrique.lluch@uv.es.'}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Artacho-Ramírez', 'Affiliation': 'Department of Engineering Projects, Universitat Politècnica de València, Camí de Vera s/n, 46022 València, Spain. Electronic address: miarra@dpi.upv.es.'}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Mayoral', 'Affiliation': 'Physical Therapy Unit, Hospital Provincial de Toledo, Toledo, Spain. Electronic address: orlando.mayoral@uclm.es.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Balasch', 'Affiliation': 'Departamento de Estadística e Investigación Operativa Aplicadas y Calidad, Universitat Politècnica de València, Camí de Vera s/n, 46022 València, Spain. Electronic address: sbalasch@eio.upv.es.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Balasch-Bernat', 'Affiliation': 'Department of Physical Therapy, University of Valencia, Gascó Oliag 5, 46010, Valencia, Spain. Electronic address: merce.balasch@uv.es.'}]","Clinical biomechanics (Bristol, Avon)",['10.1016/j.clinbiomech.2020.105071'] 1693,32521287,Evaluating the actual and perceived effectiveness of E-cigarette prevention advertisements among adolescents.,"BACKGROUND The efficacy of e-cigarette prevention ads among adolescents has seldom been studied. We examined the impact of ads from the The Real Cost vaping prevention media campaign on what adolescents think and believe about vaping. We also sought to test whether perceived message effectiveness (PME) served as a proxy for ad impact. METHODS Participants were 543 U.S. adolescents ages 13-17. In an online experiment, we randomized participants to either: 1) persuasive e-cigarette prevention video ads from the Food and Drug Administration's The Real Cost campaign that was targeted to adolescents or 2) information-only e-cigarette harms control videos (control condition). Participants in each condition viewed 2 videos in a random order. After ad exposure, the survey assessed PME (message and effects perceptions), risk beliefs about vaping, attitudes toward vaping, and intentions to vape. RESULTS The FDA's The Real Cost ads led to higher beliefs about the harms of vaping (p < .001), more negative attitudes toward vaping (p < .001), and lower intentions to vape (p < .05) compared to the control videos. The Real Cost ads also scored higher on both message perceptions (p < .001) and effects perceptions (p < .001) compared to control videos. Effects perceptions were associated with all three outcomes (all ps < 0.001, adjusting for both types of PME and covariates), but message perceptions did not offer additional predictive value. CONCLUSIONS Exposure to The Real Cost vaping prevention ads gave adolescents a more negative view of vaping and lowered their intentions to vape compared to control videos. Effects perceptions may be superior to message perceptions as a proxy for e-cigarette prevention ad impact.",2020,The Real Cost ads also scored higher on both message perceptions (p < .001) and effects perceptions (p < .001) compared to control videos.,"['Participants were 543 U.S. adolescents ages 13-17', 'adolescents']","[""1) persuasive e-cigarette prevention video ads from the Food and Drug Administration's The Real Cost campaign that was targeted to adolescents or 2) information-only e-cigarette harms control videos (control condition"", 'E-cigarette prevention advertisements']","['survey assessed PME (message and effects perceptions), risk beliefs about vaping, attitudes toward vaping, and intentions to vape']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C3849993', 'cui_str': 'Electronic cigarette'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0041714', 'cui_str': 'United States Food, Drug Administration'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0949214', 'cui_str': 'Advertisements'}]","[{'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0052148', 'cui_str': 'APEL protocol'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0291011', 'cui_str': 'VAPE protocol'}]",543.0,0.0210644,The Real Cost ads also scored higher on both message perceptions (p < .001) and effects perceptions (p < .001) compared to control videos.,"[{'ForeName': 'Seth M', 'Initials': 'SM', 'LastName': 'Noar', 'Affiliation': 'Hussman School of Journalism and Media, University of North Carolina, Chapel Hill, NC, USA; Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC, USA; Center for Health Promotion and Disease Prevention, University of North Carolina, Chapel Hill, NC, USA. Electronic address: noar@email.unc.edu.'}, {'ForeName': 'Jacob A', 'Initials': 'JA', 'LastName': 'Rohde', 'Affiliation': 'Hussman School of Journalism and Media, University of North Carolina, Chapel Hill, NC, USA.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Prentice-Dunn', 'Affiliation': 'Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC, USA.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Kresovich', 'Affiliation': 'Hussman School of Journalism and Media, University of North Carolina, Chapel Hill, NC, USA.'}, {'ForeName': 'Marissa G', 'Initials': 'MG', 'LastName': 'Hall', 'Affiliation': 'Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC, USA; Department of Health Behavior, Gillings School of Global Public Health, University of North Carolina, Chapel Hill, NC, USA; Center for Health Promotion and Disease Prevention, University of North Carolina, Chapel Hill, NC, USA.'}, {'ForeName': 'Noel T', 'Initials': 'NT', 'LastName': 'Brewer', 'Affiliation': 'Lineberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC, USA; Department of Health Behavior, Gillings School of Global Public Health, University of North Carolina, Chapel Hill, NC, USA.'}]",Addictive behaviors,['10.1016/j.addbeh.2020.106473'] 1694,32521299,Efficacy of buffered hypertonic seawater in different phenotypes of chronic rhinosinusitis with nasal polyps after endoscopic sinus surgery: a randomized double-blind study.,"PURPOSE Nasal douching is commonly used as a postoperative management strategy for chronic rhinosinusitis with nasal polyps (CRSwNP). Few studies to date have compared the effectiveness of nasal douching in CRSwNP phenotypes after endoscopic sinus surgery (ESS). We evaluated the efficacy of seawater types in eosinophilic CRSwNP (ECRSwNP) and noneosinophilic CRSwNP (nonECRSwNP) after ESS. METHODS Patients with bilateral CRSwNP who had undergone ESS were blindly randomized to receive buffered hypertonic seawater (BHS) (n = 48) or physiological seawater (PS) (n = 45). CRSwNP patients were stratified by phenotypes (ECRSwNP and nonECRSwNP) retrospectively according to whether tissue eosinophils exceeded 10%. Follow-up evaluations were conducted at 2, 8, 16, and 24 weeks after surgery. Evaluations included the 22-item Sino-Nasal Outcome Test (SNOT-22), visual analog scale (VAS), Lund-Kennedy endoscopic score (LKES), saccharine clearance time (SCT), and adverse events. RESULTS All of the patients experienced significant improvements in SNOT-22 scores, VAS scores, and LKES over time. BHS resulted in better improvement of LEKS and SCT relative to PS at 8 weeks postoperatively. Mucosal edema formation was significantly reduced with less crusting among HBS recipients at 8 weeks. After stratification, only patients in the nonECRSwNP + BHS subgroup showed a significant improvement in LEKS and SCT at 8 weeks postoperatively. Side effect profiles were not significantly different among the groups. CONCLUSIONS BHS has a better inhibitory effect on mucosal edema and crusting during the early postoperative care period of CRSwNP. Among all of the patients, nonECRSwNP patients showed a significant improvement in LEKS and SCT at 8 weeks.",2020,"Side effect profiles were not significantly different among the groups. ","['chronic rhinosinusitis with nasal polyps after endoscopic sinus surgery', 'Patients with bilateral CRSwNP who had undergone ESS', 'chronic rhinosinusitis with nasal polyps (CRSwNP']","['buffered hypertonic seawater (BHS) (n\xa0=\xa048) or physiological seawater (PS) ', 'nonECRSwNP + BHS', 'noneosinophilic CRSwNP (nonECRSwNP', 'BHS', 'buffered hypertonic seawater']","['Mucosal edema formation', '22-item Sino-Nasal Outcome Test (SNOT-22), visual analog scale (VAS), Lund-Kennedy endoscopic score (LKES), saccharine clearance time (SCT), and adverse events', 'mucosal edema and crusting', 'LEKS and SCT relative to PS', 'LEKS and SCT', 'SNOT-22 scores, VAS scores, and LKES over time']","[{'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0027430', 'cui_str': 'Polyp of nasal cavity'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0748725', 'cui_str': 'Sinus operation'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}]","[{'cui': 'C0006353', 'cui_str': 'Buffers'}, {'cui': 'C0036499', 'cui_str': 'Sea Water'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0027430', 'cui_str': 'Polyp of nasal cavity'}]","[{'cui': 'C0521481', 'cui_str': 'Mucous membrane edema'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C5197689', 'cui_str': 'Sinonasal Outcome Test'}, {'cui': 'C5197690', 'cui_str': 'SNOT-22'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205204', 'cui_str': 'Crust'}, {'cui': 'C3875154', 'cui_str': 'Relative to'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0036499', 'cui_str': 'Sea Water'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}]",,0.0772097,"Side effect profiles were not significantly different among the groups. ","[{'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Otorhinolaryngology, Head and Neck Surgery, The First Affiliated Hospital of Nanchang University, Nanchang, Jiangxi Province, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Shen', 'Affiliation': 'Department of Otorhinolaryngology, Head and Neck Surgery, The First Affiliated Hospital of Nanchang University, Nanchang, Jiangxi Province, China.'}, {'ForeName': 'Zhi-Qun', 'Initials': 'ZQ', 'LastName': 'Huang', 'Affiliation': 'Department of Otorhinolaryngology, Head and Neck Surgery, The First Affiliated Hospital of Nanchang University, Nanchang, Jiangxi Province, China.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Luo', 'Affiliation': 'Department of Otorhinolaryngology, Head and Neck Surgery, The First Affiliated Hospital of Nanchang University, Nanchang, Jiangxi Province, China.'}, {'ForeName': 'Meng-Yue', 'Initials': 'MY', 'LastName': 'Li', 'Affiliation': 'Department of Otorhinolaryngology, Head and Neck Surgery, The First Affiliated Hospital of Nanchang University, Nanchang, Jiangxi Province, China.'}, {'ForeName': 'Jun-Hao', 'Initials': 'JH', 'LastName': 'Tu', 'Affiliation': 'Department of Otorhinolaryngology, Head and Neck Surgery, The First Affiliated Hospital of Nanchang University, Nanchang, Jiangxi Province, China.'}, {'ForeName': 'Mei', 'Initials': 'M', 'LastName': 'Han', 'Affiliation': 'Department of Otorhinolaryngology, Head and Neck Surgery, The First Affiliated Hospital of Nanchang University, Nanchang, Jiangxi Province, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Ye', 'Affiliation': 'Department of Otorhinolaryngology, Head and Neck Surgery, The First Affiliated Hospital of Nanchang University, Nanchang, Jiangxi Province, China. Electronic address: yjholly@email.ncu.edu.cn.'}]",American journal of otolaryngology,['10.1016/j.amjoto.2020.102554'] 1695,32540277,High blood pressure responders show largest increase in heartbeat perception accuracy after post-learning stress following a cardiac interoceptive learning task.,"Mental disorders with physical symptoms, e.g. somatic symptom disorder, are characterized by altered interoceptive accuracy (IAc), which can be explained by individual differences in interoceptive learning (IL). We investigated if stress facilitates IL. Seventy-three healthy participants performed a heartbeat counting task (HCT: T1) and a heartbeat perception training (HBPT). After exposure to a socially-evaluated cold pressor stress test (SECPT; n = 48) or a control condition (n = 25), two more HCTs were performed (T2: 30 min after SECPT; T3: 24 h later). After the HBPT, all participants showed an increase in IAc. We separated the stress group into high vs. low systolic blood pressures (SBP) responders (n = 24 each), with high SBP responders showing the largest IAc increases. Only SBP, but not cortisol responsiveness significantly predicted IAc increase from T1 to T2. Our results indicate that post-learning autonomic stress response facilitates IL, whereas the HPA axis response may be less important for this effect.",2020,"Only SBP, but not cortisol responsiveness significantly predicted IAc increase from T1 to T2.","['Seventy-three healthy participants', 'Mental disorders with physical symptoms, e.g. somatic symptom disorder']","['heartbeat counting task (HCT: T1) and a heartbeat perception training (HBPT', 'SECPT']","['HPA axis response', 'IAc', 'systolic blood pressures (SBP) responders', 'heartbeat perception accuracy']","[{'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C4087321', 'cui_str': 'Somatic symptom disorder'}]","[{'cui': 'C0425583', 'cui_str': 'Heart beat'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0085355', 'cui_str': 'Platelet-specific antigen'}, {'cui': 'C0004457', 'cui_str': 'Bone structure of axis'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0425583', 'cui_str': 'Heart beat'}, {'cui': 'C0030971', 'cui_str': 'Perception'}]",73.0,0.014762,"Only SBP, but not cortisol responsiveness significantly predicted IAc increase from T1 to T2.","[{'ForeName': 'Lara', 'Initials': 'L', 'LastName': 'Schenk', 'Affiliation': 'Clinical Psychophysiology Laboratory, Department of Behavioural and Cognitive Sciences, University of Luxembourg, Esch-sur-Alzette, Luxembourg.'}, {'ForeName': 'Jean T M', 'Initials': 'JTM', 'LastName': 'Fischbach', 'Affiliation': 'Clinical Psychophysiology Laboratory, Department of Behavioural and Cognitive Sciences, University of Luxembourg, Esch-sur-Alzette, Luxembourg.'}, {'ForeName': 'Ruta', 'Initials': 'R', 'LastName': 'Müller', 'Affiliation': 'Clinical Psychophysiology Laboratory, Department of Behavioural and Cognitive Sciences, University of Luxembourg, Esch-sur-Alzette, Luxembourg.'}, {'ForeName': 'Claus', 'Initials': 'C', 'LastName': 'Vögele', 'Affiliation': 'Clinical Psychophysiology Laboratory, Department of Behavioural and Cognitive Sciences, University of Luxembourg, Esch-sur-Alzette, Luxembourg.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Witthöft', 'Affiliation': 'Division of Clinical Psychology, Department of Psychology, Johannes Gutenberg University of Mainz, Mainz, Germany.'}, {'ForeName': 'Ilse', 'Initials': 'I', 'LastName': 'Van Diest', 'Affiliation': 'Department of Health Psychology, Catholic University of Leuven, Leuven, Belgium.'}, {'ForeName': 'André', 'Initials': 'A', 'LastName': 'Schulz', 'Affiliation': 'Clinical Psychophysiology Laboratory, Department of Behavioural and Cognitive Sciences, University of Luxembourg, Esch-sur-Alzette, Luxembourg. Electronic address: andre.schulz@uni.lu.'}]",Biological psychology,['10.1016/j.biopsycho.2020.107919'] 1696,32540779,Comparison of simple frenotomy with 4-flap Z-frenuloplasty in treatment for ankyloglossia with articulation difficulty: A prospective randomized study.,"OBJECTIVE To compare the surgical outcomes of simple frenotomy and the 4-flap Z-frenuloplasty according to the articulation test values and tongue-tie classification in patients with ankyloglossia with articulation difficulty. STUDY DESIGN prospective randomized study. SETTING Tertiary academic center. SUBJECTS and methods: Children with ankyloglossia with articulation difficulty were randomly divided into 2 groups for surgical treatment. Patients were evaluated for the tongue-tie classification and articulation test before surgery. Three months after the operation, the frenulum classification and articulation test were re-evaluated to compare the differences in surgical outcome between the two surgical methods. RESULTS Out of 37 patients, 19 underwent the 4-flap Z-frenuloplasty and 18, the simple frenotomy. No differences were observed in the baseline characteristics of the patients assigned to both groups. Changes in the tongue-tie classification and improvement in the articulation test results were observed with both the surgical methods. Both surgical groups had significant improvement in the speech articulation test (consonants) but there was no difference in the speech outcomes between the surgical groups. CONCLUSION Although there was no significant difference in the surgical outcome between the two surgical methods, ankyloglossia patients showed improvement in a Korean speech articulation test 3 months after undergoing surgery to release the lingual frenulum.",2020,"Both surgical groups had significant improvement in the speech articulation test (consonants) but there was no difference in the speech outcomes between the surgical groups. ","['patients with ankyloglossia with articulation difficulty', 'ankyloglossia with articulation difficulty', 'and methods', 'Children with ankyloglossia with articulation difficulty', 'Tertiary academic center', '37 patients, 19 underwent the 4-flap Z-frenuloplasty and 18, the simple frenotomy']","['simple frenotomy and the 4-flap Z-frenuloplasty', 'simple frenotomy with 4-flap Z-frenuloplasty']","['speech articulation test', 'speech outcomes', 'surgical outcome', 'Korean speech articulation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0152415', 'cui_str': 'Tongue tie'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0038925', 'cui_str': 'Flap'}, {'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C0192139', 'cui_str': 'Incision of lingual frenum'}]","[{'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C0192139', 'cui_str': 'Incision of lingual frenum'}, {'cui': 'C0038925', 'cui_str': 'Flap'}]","[{'cui': 'C0037819', 'cui_str': 'Speech Articulation Tests'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}]",37.0,0.0322658,"Both surgical groups had significant improvement in the speech articulation test (consonants) but there was no difference in the speech outcomes between the surgical groups. ","[{'ForeName': 'Tae Hoon', 'Initials': 'TH', 'LastName': 'Kim', 'Affiliation': 'Department of Otorhinolaryngology - Head & Neck Surgery, School of Medicine, Kyung Hee University, Seoul, Republic of Korea.'}, {'ForeName': 'Young Chan', 'Initials': 'YC', 'LastName': 'Lee', 'Affiliation': 'Department of Otorhinolaryngology - Head & Neck Surgery, School of Medicine, Kyung Hee University, Seoul, Republic of Korea.'}, {'ForeName': 'Seung Don', 'Initials': 'SD', 'LastName': 'Yoo', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, College of Medicine, Kyung Hee University, Seoul, Republic of Korea.'}, {'ForeName': 'Seung Ah', 'Initials': 'SA', 'LastName': 'Lee', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, College of Medicine, Kyung Hee University, Seoul, Republic of Korea.'}, {'ForeName': 'Young-Gyu', 'Initials': 'YG', 'LastName': 'Eun', 'Affiliation': 'Department of Otorhinolaryngology - Head & Neck Surgery, School of Medicine, Kyung Hee University, Seoul, Republic of Korea. Electronic address: ygeun@khu.ac.kr.'}]",International journal of pediatric otorhinolaryngology,['10.1016/j.ijporl.2020.110146'] 1697,32540918,"Influences on memory for naturalistic visual episodes: sleep, familiarity, and traits differentially affect forms of recall.","The memories we form are composed of information that we extract from multifaceted episodes. Static stimuli and paired associations have proven invaluable stimuli for understanding memory, but real-life events feature spatial and temporal dimensions that help form new retrieval paths. We ask how the ability to recall semantic, temporal, and spatial aspects (the ""what, when, and where"") of naturalistic episodes is affected by three influences-prior familiarity, postencoding sleep, and individual differences-by testing their influence on three forms of recall: cued recall, free recall, and the extent that recalled details are recombined for a novel prompt. Naturalistic videos of events with rare animals were presented to 115 participants, randomly assigned to receive a 12- or 24-h delay with sleep and/or wakefulness. Participants' immediate and delayed recall was tested and coded by its spatial, temporal, and semantic content. We find that prior familiarity with items featured in events improved cued recall, but not free recall, particularly for temporal and spatial details. In contrast, postencoding sleep, relative to wakefulness, improved free recall, but not cued recall, of all forms of content. Finally, individuals with higher trait scores in the Survey of Autobiographical Memory spontaneously incorporated more spatial details during free recall, and more event details (at a trend level) in a novel recombination recall task. These findings show that prior familiarity, postencoding sleep, and memory traits can each enhance a different form of recall. More broadly, this work highlights that recall is heterogeneous in response to different influences on memory.",2020,"In contrast, postencoding sleep, relative to wakefulness, improved free recall, but not cued recall, of all forms of content.",['115 participants'],[],"['postencoding sleep, relative to wakefulness, improved free recall']","[{'cui': 'C4517540', 'cui_str': '115'}]",[],"[{'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C3875154', 'cui_str': 'Relative to'}, {'cui': 'C0043012', 'cui_str': 'Wakefulness'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}]",115.0,0.0243675,"In contrast, postencoding sleep, relative to wakefulness, improved free recall, but not cued recall, of all forms of content.","[{'ForeName': 'Marc N', 'Initials': 'MN', 'LastName': 'Coutanche', 'Affiliation': 'Department of Psychology, University of Pittsburgh, Pittsburgh, Pennsylvania 15260, USA.'}, {'ForeName': 'Griffin E', 'Initials': 'GE', 'LastName': 'Koch', 'Affiliation': 'Department of Psychology, University of Pittsburgh, Pittsburgh, Pennsylvania 15260, USA.'}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Paulus', 'Affiliation': 'Department of Psychology, University of Pittsburgh, Pittsburgh, Pennsylvania 15260, USA.'}]","Learning & memory (Cold Spring Harbor, N.Y.)",['10.1101/lm.051300.119'] 1698,32540986,Improving HPV Vaccination Rates: A Stepped-Wedge Randomized Trial.,"OBJECTIVES To evaluate the effectiveness of a stepped-wedge randomized trial of Development of Systems and Education for Human Papillomavirus Vaccination (DOSE HPV), a multilevel intervention. METHODS DOSE HPV is a 7-session program that includes interprofessional provider education, communication training, data feedback, and tailored systems change. Five primary care pediatric and/or family medicine practices completed interventions between 2016 and 2018; all chose to initiate vaccination at ages 9 to 10. We compared vaccination rates in the preintervention, intervention, and postintervention periods among 9- to 17-year-olds using random-effects generalized linear regression models appropriate for stepped-wedge design, accounting for calendar time and clustering of patients by providers and clinic. Outcomes included (1) the likelihood that eligible patients would receive vaccination during clinic visits; (2) the likelihood that adolescents would complete the series by age 13; and (3) the cumulative effect on population-level vaccine initiation and completion rates. Postintervention periods ranged from 6 to 18 months. RESULTS In the intervention and postintervention periods, the adjusted likelihood of vaccination at an eligible visit increased by >10 percentage points for ages 9 to 10 and 11 to 12, and completion of the vaccine series by age 13 increased by 4 percentage points ( P < .001 for all comparisons). Population-level vaccine initiation coverage increased from 75% (preintervention) to 84% (intervention) to 90% (postintervention), and completion increased from 60% (preintervention) to 63% (intervention) to 69% (postintervention). CONCLUSIONS Multilevel interventions that include provider education, data feedback, tailored systems changes, and early initiation of the human papillomavirus vaccine series may improve vaccine series initiation and completion beyond the conclusion of the intervention period.",2020,"Population-level vaccine initiation coverage increased from 75% (preintervention) to 84% (intervention) to 90% (postintervention), and completion increased from 60% (preintervention) to 63% (intervention) to 69% (postintervention). ",['Five primary care pediatric and/or family medicine practices completed interventions between 2016 and 2018; all chose to initiate vaccination at ages 9 to 10'],['Systems and Education for Human Papillomavirus Vaccination (DOSE HPV'],"['vaccination rates', 'HPV Vaccination Rates', 'Population-level vaccine initiation coverage', 'cumulative effect on population-level vaccine initiation and completion rates']","[{'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0015607', 'cui_str': 'Family practice'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C1997921', 'cui_str': 'Vaccination for human papillomavirus'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}]","[{'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]",,0.0663215,"Population-level vaccine initiation coverage increased from 75% (preintervention) to 84% (intervention) to 90% (postintervention), and completion increased from 60% (preintervention) to 63% (intervention) to 69% (postintervention). ","[{'ForeName': 'Rebecca B', 'Initials': 'RB', 'LastName': 'Perkins', 'Affiliation': 'Departments of Obstetrics and Gynecology and rbperkin@bu.edu.'}, {'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'Legler', 'Affiliation': 'Pediatrics and Adolescent Medicine, School of Medicine, Boston University and Boston Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Jansen', 'Affiliation': 'Continuing Medical Education Office.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Bernstein', 'Affiliation': 'Department of Health Law, Policy and Management, School of Public Health.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Pierre-Joseph', 'Affiliation': 'Pediatrics and Adolescent Medicine, School of Medicine, Boston University and Boston Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Terresa J', 'Initials': 'TJ', 'LastName': 'Eun', 'Affiliation': 'Department of Sociology, Stanford University, Stanford, California.'}, {'ForeName': 'Dea L', 'Initials': 'DL', 'LastName': 'Biancarelli', 'Affiliation': 'Department of Health Law, Policy and Management, School of Public Health.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Schuch', 'Affiliation': 'South Boston Community Health Center, Boston, Massachusetts.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Leschly', 'Affiliation': 'East Boston Neighborhood Health Center, Boston, Massachusetts; and.'}, {'ForeName': 'Anny T H R', 'Initials': 'ATHR', 'LastName': 'Fenton', 'Affiliation': 'Center for Outcomes, Research, and Evaluation, Maine Medical Center Research Institute, Portland, Maine.'}, {'ForeName': 'William G', 'Initials': 'WG', 'LastName': 'Adams', 'Affiliation': 'Pediatrics and Adolescent Medicine, School of Medicine, Boston University and Boston Medical Center, Boston, Massachusetts.'}, {'ForeName': 'Jack A', 'Initials': 'JA', 'LastName': 'Clark', 'Affiliation': 'Department of Health Law, Policy and Management, School of Public Health.'}, {'ForeName': 'Mari-Lynn', 'Initials': 'ML', 'LastName': 'Drainoni', 'Affiliation': 'Department of Health Law, Policy and Management, School of Public Health.'}, {'ForeName': 'Amresh', 'Initials': 'A', 'LastName': 'Hanchate', 'Affiliation': 'General Internal Medicine, Department of Medicine, and.'}]",Pediatrics,['10.1542/peds.2019-2737'] 1699,32541370,Can Treatment With Citicoline Eyedrops Reduce Progression in Glaucoma? The Results of a Randomized Placebo-controlled Clinical Trial.,"PRECIS Citicoline eyedrops in patients with progressing glaucoma. PURPOSE This study aimed to test whether the additional therapy with citicoline eyedrops to intraocular pressure (IOP)-lowering treatment could slow glaucoma progression in patients with worsening of damage and IOP 18 mm Hg or less. DESIGN This was a randomized, double-masked, placebo-controlled, multicenter 3-year study. OUTCOMES The outcomes studied were difference in the visual field (mean deviation, MD, of 24-2; MD of 10-2) rates of progression and difference in retinal nerve fiber layer (RNFL) thickness change between the 2 study groups at 3 years. METHODS Patients with mild to moderate open-angle glaucoma (OAG) showing damage progression of at least -0.5 dB/y in the 2 years before enrollment despite IOP ≤18 mm Hg were randomized to receive citicoline eyedrops or placebo 3 times daily for 3 years. Patients were followed every 3 months and underwent a visual field examination with 24-2 and 10-2 strategies and RNFL assessment. Analysis of variance and linear models were used to test the differences between groups. RESULTS Eighty patients were randomized in the trial. The mean 3-year rates of progression were -1.03 (2.14) dB in the citicoline group and -1.92 (2.23) dB in the placebo group (P=0.07) for 24-2 MD and -0.41 (3.45) dB in the citicoline group and -2.22 (3.63) dB in the placebo group (P=0.02) for 10-2 MD. On average, patients receiving citicoline eyedrops lost 1.86 μm of RNFL in 3 years, versus 2.99 μm in the placebo group (P=0.02). CONCLUSIONS Additional treatment with citicoline eyedrops to IOP-lowering treatment might reduce disease progression in patients with progressing glaucoma despite IOP ≤18 mm Hg.",2020,Mean three-year rates of progression were -1.03 (2.14) dB in citicoline group and -1.92,"['y in the 2 years before enrolment despite IOP ≤18▒mmHg', 'Eighty patients', 'patients with progressing glaucoma', 'Patients with mild to moderate open-angle glaucoma (OAG) showing damage progression of at least -0.5▒', 'patients with progressing glaucoma despite IOP ≤18▒mmHg', 'patients with worsening of damage and IOP 18 mmHg or less']","['Placebo', 'citicoline eyedrops or placebo', 'citicoline eyedrops', 'Citicoline Eyedrops', 'PRECIS\n\n\nCiticoline eyedrops', 'citicoline eyedrops to intraocular pressure (IOP) -lowering treatment', 'placebo']","['disease progression', 'visual field (mean deviation, MD, of 24-2; MD of 10-2) rates of progression; difference in retinal nerve fiber layer (RNFL) thickness change']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0439475', 'cui_str': 'mmHg'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0017601', 'cui_str': 'Glaucoma'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0017612', 'cui_str': 'Open-angle glaucoma'}, {'cui': 'C0010957', 'cui_str': 'Damage'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0010725', 'cui_str': 'Citicoline'}, {'cui': 'C0015399', 'cui_str': 'Eye drops'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0042826', 'cui_str': 'Visual field'}, {'cui': 'C1828170', 'cui_str': 'Mean deviation'}, {'cui': 'C0035298', 'cui_str': 'Retinal structure'}, {'cui': 'C1720466', 'cui_str': 'Nerve fiber layer'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",80.0,0.500531,Mean three-year rates of progression were -1.03 (2.14) dB in citicoline group and -1.92,"[{'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Rossetti', 'Affiliation': 'Eye Clinic, ASST Santi Paolo e Carlo, University of Milan, Milan.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Iester', 'Affiliation': 'Eye Clinic, DiNOGMI, University of Genoa.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Tranchina', 'Affiliation': 'Eye Clinic, ASST Santi Paolo e Carlo, University of Milan, Milan.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Ottobelli', 'Affiliation': 'Eye Clinic, ASST Santi Paolo e Carlo, University of Milan, Milan.'}, {'ForeName': 'Giulia', 'Initials': 'G', 'LastName': 'Coco', 'Affiliation': 'Department of Clinical Sciences and Translational Medicine, University of Tor Vergata.'}, {'ForeName': 'Elisabetta', 'Initials': 'E', 'LastName': 'Calcatelli', 'Affiliation': 'Department of Clinical Sciences and Translational Medicine, University of Tor Vergata.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Ancona', 'Affiliation': 'Eye Clinic, DiNOGMI, University of Genoa.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Cirafici', 'Affiliation': 'Eye Clinic, DiNOGMI, University of Genoa.'}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Manni', 'Affiliation': 'Department of Clinical Sciences and Translational Medicine, University of Tor Vergata.'}]",Journal of glaucoma,['10.1097/IJG.0000000000001565'] 1700,32541462,Analgesic impact of buprenorphine transdermal patch in total hip arthroplasty: A randomized controlled trial protocol.,"BACKGROUND The efficacy and safety of buprenorphine transdermal patch (BTP) has been well established in chronic pain, but data regarding acute postoperative pain relief is still very limited. Therefore, we design a prospective, randomized, controlled study to evaluate the effectiveness and safety of the BTP for postoperative analgesia in total hip arthroplasty. METHODS This study is designed as a single-center, prospective, double-blind, randomized controlled trial. Group A receives a 10 mg patch of buprenorphine at the conclusion of surgery which is continued for 14 days. Group B receives a conventional analgesic regimen, that is, IV paracetamol 1 mg every 8 hours alternating with parenteral tramadol 50 mg every 8 hours for the first 2 postoperative days followed by oral administration of the same drug still the end of 2 weeks. A total of 160 patients are needed with an allowance for 10% drop-out. The primary outcome of this noninferiority study is opioid consumption within the first 24 hours following surgery. The secondary outcomes included numerical rating scale scores at rest, postoperative complications, length of hospital stay, and patient satisfaction. RESULTS This trial is expected to be the largest randomized trial assessing the efficacy of BTP after primary total hip arthroplasty and powered to detect a potential difference in the primary outcome. TRIAL REGISTRATION NUMBER This study protocol was registered in Research Registry (researchregistry5524).",2020,"BACKGROUND The efficacy and safety of buprenorphine transdermal patch (BTP) has been well established in chronic pain, but data regarding acute postoperative pain relief is still very limited.","['160 patients are needed with an allowance for 10% drop-out', 'total hip arthroplasty']","['buprenorphine transdermal patch (BTP', 'buprenorphine transdermal patch', 'buprenorphine', 'BTP']","['opioid consumption within the first 24\u200ahours following surgery', 'numerical rating scale scores at rest, postoperative complications, length of hospital stay, and patient satisfaction', 'Analgesic impact']","[{'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C1321095', 'cui_str': 'Drop - unit of product usage'}, {'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}]","[{'cui': 'C0006405', 'cui_str': 'Buprenorphine'}, {'cui': 'C0991556', 'cui_str': 'Prolonged-release transdermal patch'}]","[{'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0443144', 'cui_str': 'At rest'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}]",160.0,0.340723,"BACKGROUND The efficacy and safety of buprenorphine transdermal patch (BTP) has been well established in chronic pain, but data regarding acute postoperative pain relief is still very limited.","[{'ForeName': 'Wen-Min', 'Initials': 'WM', 'LastName': 'Li', 'Affiliation': 'Department of Medicine, Linyi Cancer Hospital.'}, {'ForeName': 'Feng-Dao', 'Initials': 'FD', 'LastName': 'Li', 'Affiliation': 'Department of Orthopedics, Yinan County Hospital of Traditional Chinese Medicine.'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Xu', 'Affiliation': 'Department of Orthopedics, Linyi Cancer Hospital, Shandong, China.'}, {'ForeName': 'Li-Chen', 'Initials': 'LC', 'LastName': 'Sun', 'Affiliation': 'Department of Medicine, Linyi Cancer Hospital.'}]",Medicine,['10.1097/MD.0000000000020405'] 1701,32541528,Dose-response of rPMS for upper Limb hemiparesis after stroke.,"INTRODUCTION Repetitive peripheral magnetic stimulation (rPMS) therapy is an innovative and minimally invasive neurorehabilitative technique and has been shown to facilitate neural plasticity. However, there is at present no research that clarifies the dose-response of rPMS therapy on the recovery of upper limb hemiparesis after stroke. This trial aims to clarify the dose-response of rPMS therapy combined with intensive occupational therapy (OT) for chronic stroke patients with moderate to severe upper limb hemiparesis. METHODS AND ANALYSIS This multicenter, prospective, assessor-blinded, randomized controlled study with 3 parallel groups will be conducted from January 20, 2020 to September 30, 2022. Fifty patients will be randomly assigned in a ratio of 1:2:2 to the control group, the group receiving daily 2400 pulses of rPMS, or the group receiving daily 4800 pulses of rPMS, respectively. From the day after admission (Day 1), rPMS therapy and intensive OT will be initiated. The primary outcome is the change in the motor function of the affected upper extremity (Fugl-Meyer Assessment) between the time of admission (Day 0) and the day after 2 weeks of treatment (Day 14). Secondary outcomes will include the changes in spasticity, active range of motion, motor evoked potential, and activity of daily living. ETHICS AND DISSEMINATION The study was approved by the Jikei University Certified Review Board for all institutions (reference number: JKI19-020). Results of the primary and secondary outcomes will be published in a peer-reviewed journal and presented at international congresses. The results will also be disseminated to patients. TRIAL REGISTRATION NUMBER jRCTs032190191.",2020,"Secondary outcomes will include the changes in spasticity, active range of motion, motor evoked potential, and activity of daily living. ","['chronic stroke patients with moderate to severe upper limb hemiparesis', '3 parallel groups will be conducted from January 20, 2020 to September 30, 2022', 'Fifty patients']","['rPMS therapy combined with intensive occupational therapy (OT', 'rPMS therapy', 'Repetitive peripheral magnetic stimulation (rPMS) therapy', 'rPMS', 'group receiving daily 2400 pulses of rPMS, or the group receiving daily 4800 pulses of rPMS']","['changes in spasticity, active range of motion, motor evoked potential, and activity of daily living', 'change in the motor function of the affected upper extremity (Fugl-Meyer Assessment']","[{'cui': 'C3536593', 'cui_str': 'Chronic cerebrovascular accident'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0018989', 'cui_str': 'Hemiparesis'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]","[{'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C2350609', 'cui_str': 'Magnetic Stimulation Therapy'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C1318464', 'cui_str': 'Occupational therapy'}, {'cui': 'C0024488', 'cui_str': 'Magnetics'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C4517656', 'cui_str': '2400'}, {'cui': 'C0034107', 'cui_str': 'Pulse taking'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0026838', 'cui_str': 'Spasticity'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0282617', 'cui_str': 'Motor Evoked Potentials'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0234130', 'cui_str': 'Motor function'}, {'cui': 'C0392760', 'cui_str': 'Affecting'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",50.0,0.185728,"Secondary outcomes will include the changes in spasticity, active range of motion, motor evoked potential, and activity of daily living. ","[{'ForeName': 'Shoji', 'Initials': 'S', 'LastName': 'Kinoshita', 'Affiliation': 'Department of Rehabilitation Medicine.'}, {'ForeName': 'Kumi', 'Initials': 'K', 'LastName': 'Ikeda', 'Affiliation': 'Department of Rehabilitation Medicine.'}, {'ForeName': 'Shinji', 'Initials': 'S', 'LastName': 'Yasuno', 'Affiliation': 'Clinical Research Support Center, The Jikei University School of Medicine, Minato-Ku, Tokyo, Japan.'}, {'ForeName': 'Sho', 'Initials': 'S', 'LastName': 'Takahashi', 'Affiliation': 'Clinical Research Support Center, The Jikei University School of Medicine, Minato-Ku, Tokyo, Japan.'}, {'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Yamada', 'Affiliation': 'Department of Rehabilitation Medicine.'}, {'ForeName': 'Yumi', 'Initials': 'Y', 'LastName': 'Okuyama', 'Affiliation': 'Department of Rehabilitation Medicine.'}, {'ForeName': 'Nobuyuki', 'Initials': 'N', 'LastName': 'Sasaki', 'Affiliation': 'Department of Rehabilitation Medicine.'}, {'ForeName': 'Takuya', 'Initials': 'T', 'LastName': 'Hada', 'Affiliation': 'Department of Rehabilitation Medicine.'}, {'ForeName': 'Chiaki', 'Initials': 'C', 'LastName': 'Kuriyama', 'Affiliation': 'Department of Rehabilitation Medicine.'}, {'ForeName': 'Shin', 'Initials': 'S', 'LastName': 'Suzuki', 'Affiliation': 'Department of Rehabilitation Medicine.'}, {'ForeName': 'Midori', 'Initials': 'M', 'LastName': 'Hama', 'Affiliation': 'Department of Rehabilitation Medicine.'}, {'ForeName': 'Naoto', 'Initials': 'N', 'LastName': 'Ozaki', 'Affiliation': 'Department of Rehabilitation Medicine.'}, {'ForeName': 'Shu', 'Initials': 'S', 'LastName': 'Watanabe', 'Affiliation': 'Department of Rehabilitation Medicine.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Abo', 'Affiliation': 'Department of Rehabilitation Medicine.'}]",Medicine,['10.1097/MD.0000000000020752'] 1702,32541530,Comparison of sugammadex and pyridostigmine bromide for reversal of rocuronium-induced neuromuscular blockade in short-term pediatric surgery: A prospective randomized study: Retraction.,,2020,,['short-term pediatric surgery'],['sugammadex and pyridostigmine bromide'],[],"[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0279077', 'cui_str': 'Pediatric surgery'}]","[{'cui': 'C1700695', 'cui_str': 'Sugammadex'}, {'cui': 'C0034262', 'cui_str': 'Pyridostigmine bromide'}]",[],,0.0907641,,[],Medicine,['10.1097/MD.0000000000020879'] 1703,32534628,"Safety and immunogenicity of a mosquito saliva peptide-based vaccine: a randomised, placebo-controlled, double-blind, phase 1 trial.","BACKGROUND In animal models, immunity to mosquito salivary proteins protects animals against mosquito-borne disease. These findings provide a rationale to vaccinate against mosquito saliva instead of the pathogen itself. To our knowledge, no vector salivary protein-based vaccine has been tested for safety and immunogenicity in humans. We aimed to assess the safety and immunogenicity of Anopheles gambiae saliva vaccine (AGS-v), a peptide-based vaccine derived from four A gambiae salivary proteins, in humans. METHODS In this randomised, placebo-controlled, double-blind, phase 1 trial, participants were enrolled at the National Institutes of Health Clinical Center in Bethesda, MD, USA. Participants were eligible if they were healthy adults, aged 18-50 years with no history of severe allergic reactions to mosquito bites. Participants were randomly assigned (1:1:1), using block randomisation and a computer-generated randomisation sequence, to treatment with either 200 nmol of AGS-v vaccine alone, 200 nmol of AGS-v with adjuvant (Montanide ISA 51), or sterile water as placebo. Participants and clinicians were masked to treatment assignment. Participants were given a subcutaneous injection of their allocated treatment at day 0 and day 21, followed by exposure to feeding by an uninfected Aedes aegypti mosquito at day 42 to assess subsequent risk to mosquito bites in a controlled setting. The primary endpoints were safety and immunogenicity at day 42 after the first immunisation. Participants who were given at least one dose of assigned treatment were assessed for the primary endpoints and analysis was by intention to treat. The trial was registered with ClinicalTrials.gov, NCT03055000, and is closed for accrual. FINDINGS Between Feb 15 and Sept 10, 2017, we enrolled and randomly assigned 49 healthy adult participants to the adjuvanted vaccine (n=17), vaccine alone (n=16), or placebo group (n=16). Five participants did not complete the two-injection regimen with mosquito feeding at day 42, but were included in the safety analyses. No systemic safety concerns were identified; however, one participant in the adjuvanted vaccine group developed a grade 3 erythematous rash at the injection site. Pain, swelling, erythema, and itching were the most commonly reported local symptoms and were significantly increased in the adjuvanted vaccine group compared with both other treatment groups (nine [53%] of 17 participants in the adjuvanted vaccine group, two [13%] of 16 in the vaccine only group, and one [6%] of 16 in the placebo group; p=0·004). By day 42, participants who were given the adjuvanted vaccine had a significant increase in vaccine-specific total IgG antibodies compared with at baseline than did participants who were give vaccine only (absolute difference of log 10 -fold change of 0·64 [95% CI 0·39 to 0·89]; p=0·0002) and who were given placebo (0·62 [0·34 to 0·91]; p=0·0001). We saw a significant increase in IFN-γ production by peripheral blood mononuclear cells at day 42 in the adjuvanted vaccine group compared with in the placebo group (absolute difference of log 10 ratio of vaccine peptide-stimulated vs negative control 0·17 [95% CI 0·061 to 0·27]; p=0·009) but we saw no difference between the IFN-γ production in the vaccine only group compared with the placebo group (0·022 [-0·072 to 0·116]; p=0·63). INTERPRETATION AGS-v was well tolerated, and, when adjuvanted, immunogenic. These findings suggest that vector-targeted vaccine administration in humans is safe and could be a viable option for the increasing burden of vector-borne disease. FUNDING Office of the Director and the Division of Intramural Research at the National Institute of Allergy and Infectious Diseases, and National Institutes of Health.",2020,We saw a significant increase in IFN-γ production by peripheral blood mononuclear cells at day 42 in the adjuvanted vaccine group compared with in the placebo group (absolute difference of log 10 ratio of vaccine peptide-stimulated vs negative control 0·17,"['Participants were eligible if they were healthy adults, aged 18-50 years with no history of severe allergic reactions to mosquito bites', '49 healthy adult participants to the adjuvanted vaccine (n=17', 'Between Feb 15 and Sept 10, 2017', 'participants were enrolled at the National Institutes of Health Clinical Center in Bethesda, MD, USA']","['AGS-v vaccine alone, 200 nmol of AGS-v with adjuvant (Montanide ISA 51), or sterile water as placebo', 'vaccine alone', 'Anopheles gambiae saliva vaccine (AGS-v), a peptide-based vaccine', 'mosquito saliva peptide-based vaccine', 'placebo']","['Safety and immunogenicity', 'vaccine-specific total IgG antibodies', 'Pain, swelling, erythema, and itching', 'grade 3 erythematous rash', 'IFN-γ production', 'safety and immunogenicity', 'IFN-γ production by peripheral blood mononuclear cells']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0332122', 'cui_str': 'No history of'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0417744', 'cui_str': 'Mosquito bite'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0027468', 'cui_str': 'United States National Institutes of Health'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}]","[{'cui': 'C0036087', 'cui_str': 'Saliva'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0439191', 'cui_str': 'nmol'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C1311732', 'cui_str': 'montanide ISA 51'}, {'cui': 'C0359299', 'cui_str': 'sterile water'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0030956', 'cui_str': 'Peptide'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C4047355', 'cui_str': 'Mosquito saliva'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0038999', 'cui_str': 'Swelling'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0234913', 'cui_str': 'Rash erythematous'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C1321301', 'cui_str': 'Peripheral blood mononuclear cell'}]",49.0,0.7465,We saw a significant increase in IFN-γ production by peripheral blood mononuclear cells at day 42 in the adjuvanted vaccine group compared with in the placebo group (absolute difference of log 10 ratio of vaccine peptide-stimulated vs negative control 0·17,"[{'ForeName': 'Jessica E', 'Initials': 'JE', 'LastName': 'Manning', 'Affiliation': 'Laboratory of Malaria and Vector Research, National Institutes of Health, Bethesda, MD, USA. Electronic address: jessica.manning@nih.gov.'}, {'ForeName': 'Fabiano', 'Initials': 'F', 'LastName': 'Oliveira', 'Affiliation': 'Laboratory of Malaria and Vector Research, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Iliano V', 'Initials': 'IV', 'LastName': 'Coutinho-Abreu', 'Affiliation': 'Laboratory of Malaria and Vector Research, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Herbert', 'Affiliation': 'Laboratory of Malaria and Vector Research, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Meneses', 'Affiliation': 'Laboratory of Malaria and Vector Research, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Shaden', 'Initials': 'S', 'LastName': 'Kamhawi', 'Affiliation': 'Laboratory of Malaria and Vector Research, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Holly Ann', 'Initials': 'HA', 'LastName': 'Baus', 'Affiliation': 'LID Clinical Studies Unit, Laboratory of Infectious Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Han', 'Affiliation': 'LID Clinical Studies Unit, Laboratory of Infectious Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Lindsay', 'Initials': 'L', 'LastName': 'Czajkowski', 'Affiliation': 'LID Clinical Studies Unit, Laboratory of Infectious Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Luz Angela', 'Initials': 'LA', 'LastName': 'Rosas', 'Affiliation': 'LID Clinical Studies Unit, Laboratory of Infectious Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Adriana', 'Initials': 'A', 'LastName': 'Cervantes-Medina', 'Affiliation': 'LID Clinical Studies Unit, Laboratory of Infectious Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Rani', 'Initials': 'R', 'LastName': 'Athota', 'Affiliation': 'LID Clinical Studies Unit, Laboratory of Infectious Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Reed', 'Affiliation': 'LID Clinical Studies Unit, Laboratory of Infectious Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Allyson', 'Initials': 'A', 'LastName': 'Mateja', 'Affiliation': 'Clinical Monitoring Research Program Directorate, Frederick National Laboratory for Cancer Research, sponsored by the National Cancer Institute, National Institutes of Health, Frederick, MD, USA.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Hunsberger', 'Affiliation': 'Biostatistics Branch, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'James', 'Affiliation': 'SEEK, PepTcell, London, UK.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Pleguezuelos', 'Affiliation': 'SEEK, PepTcell, London, UK.'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Stoloff', 'Affiliation': 'SEEK, PepTcell, London, UK.'}, {'ForeName': 'Jesus G', 'Initials': 'JG', 'LastName': 'Valenzuela', 'Affiliation': 'Laboratory of Malaria and Vector Research, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Memoli', 'Affiliation': 'LID Clinical Studies Unit, Laboratory of Infectious Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, USA.'}]","Lancet (London, England)",['10.1016/S0140-6736(20)31048-5'] 1704,32542725,Hard and soft tissue alterations during the healing stage of immediate implant placement and provisionalization with or without connective tissue graft: A randomized clinical trial.,"AIMS To evaluate the hard and soft tissue alterations of immediately placed and provisionalized implants with or without connective tissue graft (CTG). MATERIALS AND METHODS Single unsalvageable maxillary incisors were replaced with immediately placed and provisionalized implants in 42 participants. The patients were randomly assigned to receive simultaneous CTG (test group) and not receive CTG (control group). Digital impression and cone-beam computed tomography images were obtained before extraction and after 6 months. Mid-facial gingival margin migrations, soft tissue contour changes and hard tissue remodelling were analysed and compared between the two groups using three-dimensional superimposition method. RESULTS Forty participants completed the study. The test group showed significantly less buccal tissue collapse in the area 2-5 mm apical to the gingival margin. In both groups, the mid-facial gingival margin migrated in an apico-palatal direction and the socket void, except for a triangular space in the bucco-coronal region, demonstrated radiographic new bone formation without statistically significant differences. CONCLUSIONS The CTG used with immediate implant placement and provisionalization could compensate for the facial tissue collapse, but it did not benefit maintenance of the mid-facial gingival margin position during the 6-month follow-up. New bone formation observed radiographically can be expected in most areas of the socket void, regardless of CTG use (ChiCTR-1900028494).",2020,The test group showed significantly less buccal tissue collapse in the area 2-5 mm apical to the gingival margin.,"[' Single unsalvageable maxillary incisors were replaced with immediately placed and provisionalized implants in 42 participants', 'Forty participants completed the study']","['immediate implant placement and provisionalization with or without connective tissue graft', 'simultaneous CTG (test group) and not receive CTG', 'provisionalized implants with or without connective tissue graft (CTG']","['buccal tissue collapse', 'radiographic new bone formation', 'Mid-facial gingival margin migrations, soft tissue contour changes, and hard tissue remodeling']","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0024947', 'cui_str': 'Bone structure of maxilla'}, {'cui': 'C0021156', 'cui_str': 'Structure of incisor tooth'}, {'cui': 'C0559956', 'cui_str': 'Replacement - action'}, {'cui': 'C0205548', 'cui_str': 'Stat'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0009780', 'cui_str': 'Connective tissue'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0442010', 'cui_str': 'Buccal'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0036974', 'cui_str': 'Shock'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0334168', 'cui_str': 'New bone formation'}, {'cui': 'C0444598', 'cui_str': 'Mid'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0017562', 'cui_str': 'Gingival structure'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0237731', 'cui_str': 'Human Migration'}, {'cui': 'C0225317', 'cui_str': 'Soft tissue'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0018599', 'cui_str': 'Hard'}]",42.0,0.0425291,The test group showed significantly less buccal tissue collapse in the area 2-5 mm apical to the gingival margin.,"[{'ForeName': 'Xi', 'Initials': 'X', 'LastName': 'Jiang', 'Affiliation': 'Department of Oral Implantology, Peking University School and Hospital of Stomatology, Beijing, P.R. China.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Di', 'Affiliation': 'Department of Oral Implantology, Peking University School and Hospital of Stomatology, Beijing, P.R. China.'}, {'ForeName': 'Shuxin', 'Initials': 'S', 'LastName': 'Ren', 'Affiliation': 'Department of Oral Implantology, Peking University School and Hospital of Stomatology, Beijing, P.R. China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Oral Implantology, Peking University School and Hospital of Stomatology, Beijing, P.R. China.'}, {'ForeName': 'Ye', 'Initials': 'Y', 'LastName': 'Lin', 'Affiliation': 'Department of Oral Implantology, Peking University School and Hospital of Stomatology, Beijing, P.R. China.'}]",Journal of clinical periodontology,['10.1111/jcpe.13331'] 1705,32543247,Prolonged enoxaparin therapy compared with standard-of-care antithrombotic therapy in opiate-treated patients undergoing primary percutaneous coronary intervention.,"A novel enoxaparin regimen consisting of intra-arterial bolus (0.75 mg/kg) followed by intravenous infusion (0.75 mg/kg/6 hours) has been developed as a possible solution to the delayed absorption of oral P2Y 12 inhibitors in opiate-treated ST-elevation myocardial infarction (STEMI) patients undergoing primary angioplasty. We aimed to study the feasibility of this regimen as an alternative to standard-of-care treatment (SOC) with unfractionated heparin ± glycoprotein IIb/IIIa antagonist (GPI). One hundred opiate-treated patients presenting with STEMI and accepted for primary angioplasty were randomized (1:1) to either enoxaparin or SOC. Fifty patients were allocated enoxaparin (median age 61, 40% females) and 49 allocated SOC (median age 62, 22% females). One developed stroke before angiography and was withdrawn. One SOC patient had a gastrointestinal bleed resulting in 1 g drop in hemoglobin and early cessation of GPI infusion. Two enoxaparin patients had transient minor bleeding: one transient gingival bleed and one episode of coffee ground vomit with no hemoglobin drop or hemodynamic instability. Two SOC and no enoxaparin group patients had acute stent thrombosis. These preliminary data support further study of this novel 6-hour enoxaparin regimen in opiate-treated PPCI patients.",2020,Two SOC and no enoxaparin group patients had acute stent thrombosis.,"['One hundred opiate-treated patients presenting with STEMI and accepted for primary angioplasty', 'Fifty patients were allocated', 'opiate-treated PPCI patients', 'median age 61, 40% females) and 49 allocated SOC (median age 62, 22% females', 'opiate-treated patients undergoing primary percutaneous coronary intervention']","['standard-of-care treatment (SOC) with unfractionated heparin ± glycoprotein IIb/IIIa antagonist (GPI', 'enoxaparin or SOC', 'enoxaparin therapy', 'standard-of-care antithrombotic therapy', 'enoxaparin']","['transient minor bleeding: one transient gingival bleed and one episode of coffee ground vomit with no hemoglobin drop or hemodynamic instability', 'gastrointestinal bleed', 'acute stent thrombosis']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0242401', 'cui_str': 'Opiates'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C1536220', 'cui_str': 'ST Segment Elevation Myocardial Infarction'}, {'cui': 'C1272684', 'cui_str': 'Accepted'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0162577', 'cui_str': 'Angioplasty of blood vessel'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}]","[{'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0019134', 'cui_str': 'heparin'}, {'cui': 'C0016011', 'cui_str': 'Glycoproteins IIb-IIIa'}, {'cui': 'C0231491', 'cui_str': 'Antagonist muscle action'}, {'cui': 'C0017759', 'cui_str': 'Glucose-6-phosphate isomerase'}, {'cui': 'C0206460', 'cui_str': 'Enoxaparin'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0040704', 'cui_str': 'Transients'}, {'cui': 'C0026193', 'cui_str': 'Minor'}, {'cui': 'C0017562', 'cui_str': 'Gingival structure'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0009237', 'cui_str': 'Coffee'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0162119', 'cui_str': 'Hemoglobin low'}, {'cui': 'C0948268', 'cui_str': 'Hemodynamic instability'}, {'cui': 'C0017181', 'cui_str': 'Gastrointestinal hemorrhage'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C3897493', 'cui_str': 'Stent thrombosis'}]",50.0,0.0391926,Two SOC and no enoxaparin group patients had acute stent thrombosis.,"[{'ForeName': 'Wael', 'Initials': 'W', 'LastName': 'Sumaya', 'Affiliation': 'Department of Infection, Immunity and Cardiovascular Disease, Medical School, University of Sheffield , Sheffield, UK.'}, {'ForeName': 'William A E', 'Initials': 'WAE', 'LastName': 'Parker', 'Affiliation': 'Department of Infection, Immunity and Cardiovascular Disease, Medical School, University of Sheffield , Sheffield, UK.'}, {'ForeName': 'Heather M', 'Initials': 'HM', 'LastName': 'Judge', 'Affiliation': 'Department of Infection, Immunity and Cardiovascular Disease, Medical School, University of Sheffield , Sheffield, UK.'}, {'ForeName': 'Ian R', 'Initials': 'IR', 'LastName': 'Hall', 'Affiliation': 'Department of Infection, Immunity and Cardiovascular Disease, Medical School, University of Sheffield , Sheffield, UK.'}, {'ForeName': 'Rachel C', 'Initials': 'RC', 'LastName': 'Orme', 'Affiliation': 'Department of Infection, Immunity and Cardiovascular Disease, Medical School, University of Sheffield , Sheffield, UK.'}, {'ForeName': 'Zulfiquar', 'Initials': 'Z', 'LastName': 'Adam', 'Affiliation': 'Department of Infection, Immunity and Cardiovascular Disease, Medical School, University of Sheffield , Sheffield, UK.'}, {'ForeName': 'James D', 'Initials': 'JD', 'LastName': 'Richardson', 'Affiliation': 'Department of Infection, Immunity and Cardiovascular Disease, Medical School, University of Sheffield , Sheffield, UK.'}, {'ForeName': 'Alexander M K', 'Initials': 'AMK', 'LastName': 'Rothman', 'Affiliation': 'Department of Infection, Immunity and Cardiovascular Disease, Medical School, University of Sheffield , Sheffield, UK.'}, {'ForeName': 'Kenneth P', 'Initials': 'KP', 'LastName': 'Morgan', 'Affiliation': 'Department of Infection, Immunity and Cardiovascular Disease, Medical School, University of Sheffield , Sheffield, UK.'}, {'ForeName': 'Julian P', 'Initials': 'JP', 'LastName': 'Gunn', 'Affiliation': 'Department of Infection, Immunity and Cardiovascular Disease, Medical School, University of Sheffield , Sheffield, UK.'}, {'ForeName': 'Robert F', 'Initials': 'RF', 'LastName': 'Storey', 'Affiliation': 'Department of Infection, Immunity and Cardiovascular Disease, Medical School, University of Sheffield , Sheffield, UK.'}]",Platelets,['10.1080/09537104.2020.1779925'] 1706,32543682,Effect of Continuous Glucose Monitoring on Hypoglycemia in Older Adults With Type 1 Diabetes: A Randomized Clinical Trial.,"Importance Continuous glucose monitoring (CGM) provides real-time assessment of glucose levels and may be beneficial in reducing hypoglycemia in older adults with type 1 diabetes. Objective To determine whether CGM is effective in reducing hypoglycemia compared with standard blood glucose monitoring (BGM) in older adults with type 1 diabetes. Design, Setting, and Participants Randomized clinical trial conducted at 22 endocrinology practices in the United States among 203 adults at least 60 years of age with type 1 diabetes. Interventions Participants were randomly assigned in a 1:1 ratio to use CGM (n = 103) or standard BGM (n = 100). Main Outcomes and Measures The primary outcome was CGM-measured percentage of time that sensor glucose values were less than 70 mg/dL during 6 months of follow-up. There were 31 prespecified secondary outcomes, including additional CGM metrics for hypoglycemia, hyperglycemia, and glucose control; hemoglobin A1c (HbA1c); and cognition and patient-reported outcomes, with adjustment for multiple comparisons to control for false-discovery rate. Results Of the 203 participants (median age, 68 [interquartile range {IQR}, 65-71] years; median type 1 diabetes duration, 36 [IQR, 25-48] years; 52% female; 53% insulin pump use; mean HbA1c, 7.5% [SD, 0.9%]), 83% used CGM at least 6 days per week during month 6. Median time with glucose levels less than 70 mg/dL was 5.1% (73 minutes per day) at baseline and 2.7% (39 minutes per day) during follow-up in the CGM group vs 4.7% (68 minutes per day) and 4.9% (70 minutes per day), respectively, in the standard BGM group (adjusted treatment difference, -1.9% (-27 minutes per day); 95% CI, -2.8% to -1.1% [-40 to -16 minutes per day]; P <.001). Of the 31 prespecified secondary end points, there were statistically significant differences for all 9 CGM metrics, 6 of 7 HbA1c outcomes, and none of the 15 cognitive and patient-reported outcomes. Mean HbA1c decreased in the CGM group compared with the standard BGM group (adjusted group difference, -0.3%; 95% CI, -0.4% to -0.1%; P <.001). The most commonly reported adverse events using CGM and standard BGM, respectively, were severe hypoglycemia (1 and 10), fractures (5 and 1), falls (4 and 3), and emergency department visits (6 and 8). Conclusions and Relevance Among adults aged 60 years or older with type 1 diabetes, continuous glucose monitoring compared with standard blood glucose monitoring resulted in a small but statistically significant improvement in hypoglycemia over 6 months. Further research is needed to understand the long-term clinical benefit. Trial Registration ClinicalTrials.gov Identifier: NCT03240432.",2020,"Mean HbA1c decreased in the CGM group compared with the standard BGM group (adjusted group difference, -0.3%; 95% CI, -0.4% to -0.1%; P <.001).","['older adults with type 1 diabetes', '22 endocrinology practices in the United States among 203 adults at least 60 years of age with type 1 diabetes', 'Older Adults With Type 1 Diabetes', 'adults aged 60 years or older with type 1 diabetes', '203 participants (median age, 68 [interquartile range {IQR}, 65-71] years; median type 1 diabetes duration, 36 [IQR, 25-48] years; 52% female; 53% insulin pump use; mean HbA1c, 7.5% [SD, 0.9%]), 83% used']","['CGM', 'standard blood glucose monitoring (BGM', 'CGM (n\u2009=\u2009103) or standard BGM', 'standard BGM', 'Importance\n\n\nContinuous glucose monitoring (CGM', 'standard blood glucose monitoring', 'Continuous Glucose Monitoring']","['severe hypoglycemia (1 and 10), fractures (5 and 1), falls (4 and 3), and emergency department visits', 'Hypoglycemia', 'Mean HbA1c', 'hypoglycemia', 'additional CGM metrics for hypoglycemia, hyperglycemia, and glucose control; hemoglobin A1c (HbA1c); and cognition and patient-reported outcomes, with adjustment for multiple comparisons to control for false-discovery rate', 'CGM-measured percentage of time that sensor glucose values', 'Median time with glucose levels']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0014137', 'cui_str': 'Endocrinology'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0011854', 'cui_str': 'Type 1 diabetes mellitus'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1140609', 'cui_str': 'Insulin pump'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C4517859', 'cui_str': '7.5'}, {'cui': 'C4068881', 'cui_str': '0.9'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C4517526', 'cui_str': '103'}]","[{'cui': 'C4728082', 'cui_str': 'Severe hypoglycaemia'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0586082', 'cui_str': 'Emergency department patient visit'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0699680', 'cui_str': 'Metric'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0376209', 'cui_str': 'Adjustment'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0205557', 'cui_str': 'False positive'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0183210', 'cui_str': 'Sensor device'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement'}]",203.0,0.1795,"Mean HbA1c decreased in the CGM group compared with the standard BGM group (adjusted group difference, -0.3%; 95% CI, -0.4% to -0.1%; P <.001).","[{'ForeName': 'Richard E', 'Initials': 'RE', 'LastName': 'Pratley', 'Affiliation': 'AdventHealth Translational Research Institute, Orlando, Florida.'}, {'ForeName': 'Lauren G', 'Initials': 'LG', 'LastName': 'Kanapka', 'Affiliation': 'Jaeb Center for Health Research, Tampa, Florida.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Rickels', 'Affiliation': 'Rodebaugh Diabetes Center, University of Pennsylvania Perelman School of Medicine, Philadelphia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Ahmann', 'Affiliation': 'Oregon Health and Science University, Portland.'}, {'ForeName': 'Grazia', 'Initials': 'G', 'LastName': 'Aleppo', 'Affiliation': 'Feinberg School of Medicine, Northwestern University, Chicago, Illinois.'}, {'ForeName': 'Roy', 'Initials': 'R', 'LastName': 'Beck', 'Affiliation': 'Jaeb Center for Health Research, Tampa, Florida.'}, {'ForeName': 'Anuj', 'Initials': 'A', 'LastName': 'Bhargava', 'Affiliation': 'Iowa Diabetes and Endocrinology Research Center, Des Moines.'}, {'ForeName': 'Bruce W', 'Initials': 'BW', 'LastName': 'Bode', 'Affiliation': 'Atlanta Diabetes Associates, Atlanta, Georgia.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Carlson', 'Affiliation': 'Park Nicollet International Diabetes Center, Minneapolis, Minnesota.'}, {'ForeName': 'Naomi S', 'Initials': 'NS', 'LastName': 'Chaytor', 'Affiliation': 'Elson S. Floyd College of Medicine, Washington State University, Spokane.'}, {'ForeName': 'D Steven', 'Initials': 'DS', 'LastName': 'Fox', 'Affiliation': 'University of South California, School of Pharmacy, Los Angeles.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Goland', 'Affiliation': 'Naomi Berri Diabetes Center, Columbia University, New York, New York.'}, {'ForeName': 'Irl B', 'Initials': 'IB', 'LastName': 'Hirsch', 'Affiliation': 'University of Washington, Seattle.'}, {'ForeName': 'Davida', 'Initials': 'D', 'LastName': 'Kruger', 'Affiliation': 'Henry Ford Health System, Detroit, Michigan.'}, {'ForeName': 'Yogish C', 'Initials': 'YC', 'LastName': 'Kudva', 'Affiliation': 'Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Levy', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Janet B', 'Initials': 'JB', 'LastName': 'McGill', 'Affiliation': 'Washington University School of Medicine in St Louis, St Louis, Missouri.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Peters', 'Affiliation': 'Keck School of Medicine, University of Southern California, Los Angeles.'}, {'ForeName': 'Louis', 'Initials': 'L', 'LastName': 'Philipson', 'Affiliation': 'University of Chicago, Chicago, Illinois.'}, {'ForeName': 'Athena', 'Initials': 'A', 'LastName': 'Philis-Tsimikas', 'Affiliation': 'Scripps Whittier Diabetes Institute, La Jolla, California.'}, {'ForeName': 'Rodica', 'Initials': 'R', 'LastName': 'Pop-Busui', 'Affiliation': 'University of Michigan, Ann Arbor.'}, {'ForeName': 'Viral N', 'Initials': 'VN', 'LastName': 'Shah', 'Affiliation': 'Barbara Davis Center for Diabetes, University of Colorado Anschutz Medical Campus, Aurora.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Thompson', 'Affiliation': 'University of Massachusetts Medical School, Worcester.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Vendrame', 'Affiliation': 'University of Miami, Miami, Florida.'}, {'ForeName': 'Alandra', 'Initials': 'A', 'LastName': 'Verdejo', 'Affiliation': 'Jaeb Center for Health Research, Tampa, Florida.'}, {'ForeName': 'Ruth S', 'Initials': 'RS', 'LastName': 'Weinstock', 'Affiliation': 'SUNY Upstate Medical University, Syracuse, New York.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Young', 'Affiliation': 'University of North Carolina at Chapel Hill, Chapel Hill.'}, {'ForeName': 'Kellee M', 'Initials': 'KM', 'LastName': 'Miller', 'Affiliation': 'Jaeb Center for Health Research, Tampa, Florida.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA,['10.1001/jama.2020.6928'] 1707,32543683,Effect of Continuous Glucose Monitoring on Glycemic Control in Adolescents and Young Adults With Type 1 Diabetes: A Randomized Clinical Trial.,"Importance Adolescents and young adults with type 1 diabetes exhibit the worst glycemic control among individuals with type 1 diabetes across the lifespan. Although continuous glucose monitoring (CGM) has been shown to improve glycemic control in adults, its benefit in adolescents and young adults has not been demonstrated. Objective To determine the effect of CGM on glycemic control in adolescents and young adults with type 1 diabetes. Design, Setting, and Participants Randomized clinical trial conducted between January 2018 and May 2019 at 14 endocrinology practices in the US including 153 individuals aged 14 to 24 years with type 1 diabetes and screening hemoglobin A1c (HbA1c) of 7.5% to 10.9%. Interventions Participants were randomized 1:1 to undergo CGM (CGM group; n = 74) or usual care using a blood glucose meter for glucose monitoring (blood glucose monitoring [BGM] group; n = 79). Main Outcomes and Measures The primary outcome was change in HbA1c from baseline to 26 weeks. There were 20 secondary outcomes, including additional HbA1c outcomes, CGM glucose metrics, and patient-reported outcomes with adjustment for multiple comparisons to control for the false discovery rate. Results Among the 153 participants (mean [SD] age, 17 [3] years; 76 [50%] were female; mean [SD] diabetes duration, 9 [5] years), 142 (93%) completed the study. In the CGM group, 68% of participants used CGM at least 5 days per week in month 6. Mean HbA1c was 8.9% at baseline and 8.5% at 26 weeks in the CGM group and 8.9% at both baseline and 26 weeks in the BGM group (adjusted between-group difference, -0.37% [95% CI, -0.66% to -0.08%]; P = .01). Of 20 prespecified secondary outcomes, there were statistically significant differences in 3 of 7 binary HbA1c outcomes, 8 of 9 CGM metrics, and 1 of 4 patient-reported outcomes. The most commonly reported adverse events in the CGM and BGM groups were severe hypoglycemia (3 participants with an event in the CGM group and 2 in the BGM group), hyperglycemia/ketosis (1 participant with an event in CGM group and 4 in the BGM group), and diabetic ketoacidosis (3 participants with an event in the CGM group and 1 in the BGM group). Conclusions and Relevance Among adolescents and young adults with type 1 diabetes, continuous glucose monitoring compared with standard blood glucose monitoring resulted in a small but statistically significant improvement in glycemic control over 26 weeks. Further research is needed to understand the clinical importance of the findings. Trial Registration ClinicalTrials.gov Identifier: NCT03263494.",2020,"Mean HbA1c was 8.9% at baseline and 8.5% at 26 weeks in the CGM group and 8.9% at both baseline and 26 weeks in the BGM group (adjusted between-group difference, -0.37% [95% CI, -0.66% to -0.08%]; P = .01).","['Importance\n\n\nAdolescents and young adults with type 1 diabetes', 'Adolescents and Young Adults With Type 1 Diabetes', '153 participants (mean [SD] age, 17 [3] years; 76 [50%] were female; mean [SD] diabetes duration, 9 [5] years), 142 (93%) completed the study', 'adolescents and young adults with type 1 diabetes', 'January 2018 and May 2019 at 14 endocrinology practices in the US including 153 individuals aged 14 to 24 years with type 1 diabetes and screening hemoglobin A1c (HbA1c) of 7.5% to 10.9']","['CGM (CGM group; n\u2009=\u200974) or usual care using a blood glucose meter for glucose monitoring (blood glucose monitoring [BGM] group; n\u2009=\u200979', 'continuous glucose monitoring (CGM', 'Continuous Glucose Monitoring', 'CGM']","['severe hypoglycemia', 'hyperglycemia/ketosis', 'Mean HbA1c', 'additional HbA1c outcomes, CGM glucose metrics, and patient-reported outcomes with adjustment for multiple comparisons to control for the false discovery rate', 'diabetic ketoacidosis', 'glycemic control', 'adverse events', 'change in HbA1c']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0014137', 'cui_str': 'Endocrinology'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0472226', 'cui_str': 'Blood glucose meters'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}]","[{'cui': 'C4728082', 'cui_str': 'Severe hypoglycaemia'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0022638', 'cui_str': 'Ketosis'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0202048', 'cui_str': 'Glucose measurement by monitoring device'}, {'cui': 'C0699680', 'cui_str': 'Metric'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0376209', 'cui_str': 'Adjustment'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205557', 'cui_str': 'False positive'}, {'cui': 'C0011880', 'cui_str': 'Diabetic ketoacidosis'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]",3.0,0.108319,"Mean HbA1c was 8.9% at baseline and 8.5% at 26 weeks in the CGM group and 8.9% at both baseline and 26 weeks in the BGM group (adjusted between-group difference, -0.37% [95% CI, -0.66% to -0.08%]; P = .01).","[{'ForeName': 'Lori M', 'Initials': 'LM', 'LastName': 'Laffel', 'Affiliation': 'Joslin Diabetes Center, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Lauren G', 'Initials': 'LG', 'LastName': 'Kanapka', 'Affiliation': 'Jaeb Center for Health Research, Tampa, Florida.'}, {'ForeName': 'Roy W', 'Initials': 'RW', 'LastName': 'Beck', 'Affiliation': 'Jaeb Center for Health Research, Tampa, Florida.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Bergamo', 'Affiliation': 'University of North Carolina Diabetes Care Center, Chapel Hill.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Clements', 'Affiliation': ""Children's Mercy Hospital, Kansas City, Missouri.""}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Criego', 'Affiliation': 'Health Partners Institute, International Diabetes Center, St Louis Park, Minnesota.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'DeSalvo', 'Affiliation': 'Baylor College of Medicine, Houston, Texas.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Goland', 'Affiliation': 'Naomi Berrie Diabetes Center, Columbia University, New York, New York.'}, {'ForeName': 'Korey', 'Initials': 'K', 'LastName': 'Hood', 'Affiliation': 'Stanford University, Palo Alto, California.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Liljenquist', 'Affiliation': 'Rocky Mountain Diabetes & Osteoporosis Center, Idaho Falls, Idaho.'}, {'ForeName': 'Laurel H', 'Initials': 'LH', 'LastName': 'Messer', 'Affiliation': ''}, {'ForeName': 'Roshanak', 'Initials': 'R', 'LastName': 'Monzavi', 'Affiliation': ""Children's Hospital Los Angeles, Los Angeles, California.""}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Mouse', 'Affiliation': 'Jaeb Center for Health Research, Tampa, Florida.'}, {'ForeName': 'Priya', 'Initials': 'P', 'LastName': 'Prahalad', 'Affiliation': 'Stanford University, Palo Alto, California.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Sherr', 'Affiliation': ""Yale Children's Diabetes Program, New Haven, Connecticut.""}, {'ForeName': 'Jill H', 'Initials': 'JH', 'LastName': 'Simmons', 'Affiliation': 'Vanderbilt University Medical Center, Nashville, Tennessee.'}, {'ForeName': 'R Paul', 'Initials': 'RP', 'LastName': 'Wadwa', 'Affiliation': 'Barbara Davis Center for Childhood Diabetes, Aurora, Colorado.'}, {'ForeName': 'Ruth S', 'Initials': 'RS', 'LastName': 'Weinstock', 'Affiliation': 'SUNY Upstate Medical University, Syracuse, New York.'}, {'ForeName': 'Steven M', 'Initials': 'SM', 'LastName': 'Willi', 'Affiliation': 'Childrens Hospital of Philadelphia, Philadelphia, Pennsylvania.'}, {'ForeName': 'Kellee M', 'Initials': 'KM', 'LastName': 'Miller', 'Affiliation': 'Jaeb Center for Health Research, Tampa, Florida.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA,['10.1001/jama.2020.6940'] 1708,32543684,Effect of Ticagrelor Monotherapy vs Ticagrelor With Aspirin on Major Bleeding and Cardiovascular Events in Patients With Acute Coronary Syndrome: The TICO Randomized Clinical Trial.,"Importance Discontinuing aspirin after short-term dual antiplatelet therapy (DAPT) was evaluated as a bleeding reduction strategy. However, the strategy of ticagrelor monotherapy has not been exclusively evaluated in patients with acute coronary syndromes (ACS). Objective To determine whether switching to ticagrelor monotherapy after 3 months of DAPT reduces net adverse clinical events compared with ticagrelor-based 12-month DAPT in patients with ACS treated with drug-eluting stents. Design, Setting, and Participants A randomized multicenter trial was conducted in 3056 patients with ACS treated with drug-eluting stents between August 2015 and October 2018 at 38 centers in South Korea. Follow-up was completed in October 2019. Interventions Patients were randomized to receive ticagrelor monotherapy (90 mg twice daily) after 3-month DAPT (n = 1527) or ticagrelor-based 12-month DAPT (n = 1529). Main Outcomes and Measures The primary outcome was a 1-year net adverse clinical event, defined as a composite of major bleeding and adverse cardiac and cerebrovascular events (death, myocardial infarction, stent thrombosis, stroke, or target-vessel revascularization). Prespecified secondary outcomes included major bleeding and major adverse cardiac and cerebrovascular events. Results Among 3056 patients who were randomized (mean age, 61 years; 628 women [20%]; 36% ST-elevation myocardial infarction), 2978 patients (97.4%) completed the trial. The primary outcome occurred in 59 patients (3.9%) receiving ticagrelor monotherapy after 3-month DAPT and in 89 patients (5.9%) receiving ticagrelor-based 12-month DAPT (absolute difference, -1.98% [95% CI, -3.50% to -0.45%]; hazard ratio [HR], 0.66 [95% CI, 0.48 to 0.92]; P = .01). Of 10 prespecified secondary outcomes, 8 showed no significant difference. Major bleeding occurred in 1.7% of patients with ticagrelor monotherapy after 3-month DAPT and in 3.0% of patients with ticagrelor-based 12-month DAPT (HR, 0.56 [95% CI, 0.34 to 0.91]; P = .02). The incidence of major adverse cardiac and cerebrovascular events was not significantly different between the ticagrelor monotherapy after 3-month DAPT group (2.3%) vs the ticagrelor-based 12-month DAPT group (3.4%) (HR, 0.69 [95% CI, 0.45 to 1.06]; P = .09). Conclusions and Relevance Among patients with acute coronary syndromes treated with drug-eluting stents, ticagrelor monotherapy after 3 months of dual antiplatelet therapy, compared with ticagrelor-based 12-month dual antiplatelet therapy, resulted in a modest but statistically significant reduction in a composite outcome of major bleeding and cardiovascular events at 1 year. The study population and lower than expected event rates should be considered in interpreting the trial. Trial Registration ClinicalTrials.gov Identifier: NCT02494895.",2020,"The incidence of major adverse cardiac and cerebrovascular events was not significantly different between the ticagrelor monotherapy after 3-month DAPT group (2.3%) vs the ticagrelor-based 12-month DAPT group (3.4%) (HR, 0.69 [95% CI, 0.45 to 1.06]; P = .09). ","['patients with acute coronary syndromes treated with drug-eluting stents', 'Patients', '3056 patients with ACS treated with drug-eluting stents between August 2015 and October 2018 at 38 centers in South Korea', 'patients with acute coronary syndromes (ACS', 'patients with ACS treated with drug-eluting stents', 'With Acute Coronary Syndrome', '3056 patients who were randomized (mean age, 61 years; 628 women [20%]; 36% ST-elevation myocardial infarction), 2978 patients (97.4%) completed the trial']","['DAPT', 'ticagrelor-based 12-month DAPT', 'Ticagrelor Monotherapy vs Ticagrelor', 'Aspirin', 'aspirin', 'ticagrelor monotherapy']","['major bleeding and cardiovascular events', 'Major Bleeding and Cardiovascular Events', 'incidence of major adverse cardiac and cerebrovascular events', 'Major bleeding', 'major bleeding and major adverse cardiac and cerebrovascular events', '1-year net adverse clinical event, defined as a composite of major bleeding and adverse cardiac and cerebrovascular events (death, myocardial infarction, stent thrombosis, stroke, or target-vessel revascularization']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C1322815', 'cui_str': 'Drug eluting stent'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0022773', 'cui_str': 'Republic of Korea'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1303258', 'cui_str': 'Acute ST segment elevation myocardial infarction'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}, {'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1456447', 'cui_str': 'SLC6A2 protein, human'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C3897493', 'cui_str': 'Stent thrombosis'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0449618', 'cui_str': 'Target vessel'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}]",3056.0,0.102151,"The incidence of major adverse cardiac and cerebrovascular events was not significantly different between the ticagrelor monotherapy after 3-month DAPT group (2.3%) vs the ticagrelor-based 12-month DAPT group (3.4%) (HR, 0.69 [95% CI, 0.45 to 1.06]; P = .09). ","[{'ForeName': 'Byeong-Keuk', 'Initials': 'BK', 'LastName': 'Kim', 'Affiliation': 'Severance Cardiovascular Hospital, Yonsei University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Sung-Jin', 'Initials': 'SJ', 'LastName': 'Hong', 'Affiliation': 'Severance Cardiovascular Hospital, Yonsei University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Yun-Hyeong', 'Initials': 'YH', 'LastName': 'Cho', 'Affiliation': 'Myongji Hospital, Hanyang University College of Medicine, Goyang, South Korea.'}, {'ForeName': 'Kyeong Ho', 'Initials': 'KH', 'LastName': 'Yun', 'Affiliation': 'Wonkwang University Hospital, Iksan, South Korea.'}, {'ForeName': 'Yong Hoon', 'Initials': 'YH', 'LastName': 'Kim', 'Affiliation': 'Kangwon National University School of Medicine, Chuncheon, South Korea.'}, {'ForeName': 'Yongsung', 'Initials': 'Y', 'LastName': 'Suh', 'Affiliation': 'Myongji Hospital, Hanyang University College of Medicine, Goyang, South Korea.'}, {'ForeName': 'Jae Young', 'Initials': 'JY', 'LastName': 'Cho', 'Affiliation': 'Wonkwang University Hospital, Iksan, South Korea.'}, {'ForeName': 'Ae-Young', 'Initials': 'AY', 'LastName': 'Her', 'Affiliation': 'Kangwon National University School of Medicine, Chuncheon, South Korea.'}, {'ForeName': 'Sungsoo', 'Initials': 'S', 'LastName': 'Cho', 'Affiliation': 'Dankook University Hospital, Dankook University College of Medicine, Cheonan, South Korea.'}, {'ForeName': 'Dong Woon', 'Initials': 'DW', 'LastName': 'Jeon', 'Affiliation': 'National Health Insurance Service Ilsan Hospital, Goyang-City, South Korea.'}, {'ForeName': 'Sang-Yong', 'Initials': 'SY', 'LastName': 'Yoo', 'Affiliation': 'Gangneung Asan Hospital, University of Ulsan College of Medicine, Gangneung, South Korea.'}, {'ForeName': 'Deok-Kyu', 'Initials': 'DK', 'LastName': 'Cho', 'Affiliation': 'Yongin Severance Hospital, Yonsei University College of Medicine, Yongin, South Korea.'}, {'ForeName': 'Bum-Kee', 'Initials': 'BK', 'LastName': 'Hong', 'Affiliation': 'Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Hyuckmoon', 'Initials': 'H', 'LastName': 'Kwon', 'Affiliation': 'Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Chul-Min', 'Initials': 'CM', 'LastName': 'Ahn', 'Affiliation': 'Severance Cardiovascular Hospital, Yonsei University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Dong-Ho', 'Initials': 'DH', 'LastName': 'Shin', 'Affiliation': 'Severance Cardiovascular Hospital, Yonsei University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Chung-Mo', 'Initials': 'CM', 'LastName': 'Nam', 'Affiliation': 'Department of Preventive Medicine and Biostatistics, Yonsei University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Jung-Sun', 'Initials': 'JS', 'LastName': 'Kim', 'Affiliation': 'Severance Cardiovascular Hospital, Yonsei University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Young-Guk', 'Initials': 'YG', 'LastName': 'Ko', 'Affiliation': 'Severance Cardiovascular Hospital, Yonsei University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Donghoon', 'Initials': 'D', 'LastName': 'Choi', 'Affiliation': 'Severance Cardiovascular Hospital, Yonsei University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Myeong-Ki', 'Initials': 'MK', 'LastName': 'Hong', 'Affiliation': 'Severance Cardiovascular Hospital, Yonsei University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Yangsoo', 'Initials': 'Y', 'LastName': 'Jang', 'Affiliation': 'Severance Cardiovascular Hospital, Yonsei University College of Medicine, Seoul, South Korea.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA,['10.1001/jama.2020.7580'] 1709,32535263,Effects of edaravone on postoperative cognitive function in elderly patients undergoing hip joint replacement surgery: A randomized controlled trial.,"BACKGROUND Postoperative cognitive dysfunction (POCD) is a complication of central nervous system in patients after surgery. Edaravone as a brain-protective agent may have protective effect on postoperative cognitive function. The study was designed to explore the effects of edaravone on postoperative cognitive function in elderly patients undergoing hip joint replacement surgery and potential mechanism. PATIENTS AND METHODS Patients undergoing hip joint replacement surgery were randomly allocated into 2 groups: the edaravone group (group E) and the control group (group C). Group E received intravenous edaravone at a dose of 0.5 mg/kg after induction of anesthesia, while group C received normal saline. The cognitive function was evaluated with the Mini-Mental State Examination (MMSE) 1day before surgery,3 days and the 7 days after surgery. Patients' plasma samples were collected to detect the levels of S100β protein (S100β), interleukin-6 (IL-6), matrix metalloproteinase-9 (MMP-9), superoxide dismutase (SOD) and malondialdehyde (MDA) before the induction of anesthesia, at the end of surgery and on postoperative day 3. RESULTS The MMSE scores in group E were higher than those of group C 3 days after surgery (25.98 ± 1.99 vs 24.86 ± 1.86, p = 0.003). There were remarkable rises (p < 0.05) in plasma IL-6, S100βand MMP-9 levels at the end of surgery and on postoperative day 3 in the two groups, however, edaravone pretreatment could reduce these levels to a certain extent compared with group C (p < 0.05).In group E, the SOD concentration was higher at the end of surgery (16.03 ± 2.46U/ml vs. 13.65 ± 2.53U/ml, p = 0.0001), while the MDA level was lower on postoperative day 3 than those in group C (7.01 ± 2.37 nmol/ml vs. 11.34 ± 3.18 nmol/ml, p = 0.0001). CONCLUSION The results indicated that preoperative intervention with edaravone may improve the postoperative cognitive function in elderly patients undergoing hip joint replacement surgery.",2020,"There were remarkable rises (p< 0.05) in plasma IL-6, S100βand MMP-9 levels at the end of surgery and on postoperative day 3 in the two groups, however, edaravone pretreatment could reduce these levels to a certain extent compared with group C (p< 0.05).In group E, the SOD concentration was higher at the end of surgery (16.03±2.46U/ml vs. 13.65±2.53U/ml, p = 0.0001), while the MDA level was lower on postoperative day 3 than those in group C (7.01±2.37nmol/ml vs. 11.34±3.18nmol/ml, p = 0.0001). ","['eldely patients undergoing hip joint replacement surgery and potential mechanism', 'Patients undergoing hip joint replacement surgery', 'patients after surgery', 'elderly patients undergoing hip joint replacement surgery']","['intravenous edaravone', 'normal saline', 'edaravone', 'Edaravone']","['MDA level', 'MMSE scores', 'cognitive function', 'SOD concentration', 'levels of S100β protein (S100β), interleukin-6 (IL-6), matrix metalloproteinase-9 (MMP-9), superoxide dismutase (SOD) and malondialdehyde (MDA', 'postoperative cognitive function', 'plasma IL-6, S100βand MMP-9 levels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019558', 'cui_str': 'Hip joint structure'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0441712', 'cui_str': 'Mechanisms'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0070694', 'cui_str': 'edaravone'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}]","[{'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C2960235', 'cui_str': 'Mini-mental state examination score'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0038838', 'cui_str': 'Superoxide Dismutase'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0165519', 'cui_str': 'Gelatinase B'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}]",,0.097904,"There were remarkable rises (p< 0.05) in plasma IL-6, S100βand MMP-9 levels at the end of surgery and on postoperative day 3 in the two groups, however, edaravone pretreatment could reduce these levels to a certain extent compared with group C (p< 0.05).In group E, the SOD concentration was higher at the end of surgery (16.03±2.46U/ml vs. 13.65±2.53U/ml, p = 0.0001), while the MDA level was lower on postoperative day 3 than those in group C (7.01±2.37nmol/ml vs. 11.34±3.18nmol/ml, p = 0.0001). ","[{'ForeName': 'Nan-Nan', 'Initials': 'NN', 'LastName': 'Zhang', 'Affiliation': 'Department of Anesthesiology, Shanghai Pudong Hospital, Fudan University Pudong Medical Center, 2800 Gongwei Road, Huinan Town, Pudong, Shanghai, 201399, China.'}, {'ForeName': 'Long', 'Initials': 'L', 'LastName': 'Sun', 'Affiliation': 'Department of Anesthesiology, Shuguang Hospital Affiliated to Shanghai University of Chinese Traditional Medicine, 528 Zhangheng Road, Pudong, Shanghai, 201203, China. Electronic address: sun_long2@163.com.'}, {'ForeName': 'Wen-Ting', 'Initials': 'WT', 'LastName': 'Chen', 'Affiliation': 'Department of Anesthesiology, Shuguang Hospital Affiliated to Shanghai University of Chinese Traditional Medicine, 528 Zhangheng Road, Pudong, Shanghai, 201203, China.'}, {'ForeName': 'Yang-Liang', 'Initials': 'YL', 'LastName': 'Yang', 'Affiliation': 'Department of Anesthesiology, Shanghai Pudong Hospital, Fudan University Pudong Medical Center, 2800 Gongwei Road, Huinan Town, Pudong, Shanghai, 201399, China.'}, {'ForeName': 'Yi-Ming', 'Initials': 'YM', 'LastName': 'Wu', 'Affiliation': 'Department of Anesthesiology, Shanghai Pudong Hospital, Fudan University Pudong Medical Center, 2800 Gongwei Road, Huinan Town, Pudong, Shanghai, 201399, China. Electronic address: nange1984@sina.com.'}]","International journal of surgery (London, England)",['10.1016/j.ijsu.2020.05.092'] 1710,32535338,A serious-game for child sexual abuse prevention: An evaluation of orbit.,"BACKGROUND Greater public and professional awareness of the extent and impact of child sexual abuse (CSA) has prompted the inclusions of prevention initiatives within school curricula. However CSA education is not always soundly grounded in empirical evidence, and evaluations of the impact of programs often inadequate. OBJECTIVE This paper reports on a randomized-control trial of an empirically informed serious-game for CSA prevention, for children aged 8-10 years. The study also evaluates the impact on learning of complementary classroom lessons and part completion of the Orbit game. PARTICIPANTS AND SETTING The evaluation involved 139 students (female = 78; male = 61) aged 8-10 years (Mage = 9.64, SD = 0.33), from an elementary school in Queensland, Australia. METHOD All children were pre-tested and post-tested (at 3 months) for knowledge of abuse prevention using the Children's Knowledge of Abuse Questionnaire-Revised (CKAQ-R-III), and a short form (SF) mapped to the learning objectives of Orbit . Children were assigned to one of three groups; i) play Orbit (n = 50); ii) play Orbit and CSA lessons (n = 55); and iii) control (n = 34). RESULTS Children in the Orbit play, and Orbit play and lesson groups, significantly (p < .001) increased their CKAQ SF scores, whereas those in the control group did not. Furthermore, those children who completed all of Orbit significantly (p < .001) increased their post-test CKAQ scores, whereas those who didn't complete the game did not. CONCLUSIONS This study shows the strength of a serious-games approach for school CSA prevention whilst reporting how child completion can impact learnings.",2020,"RESULTS Children in the Orbit play, and Orbit play and lesson groups, significantly (p < .001) increased their CKAQ SF scores, whereas those in the control group did not.","['child sexual abuse (CSA', 'child sexual abuse prevention', ""All children were pre-tested and post-tested (at 3 months) for knowledge of abuse prevention using the Children's Knowledge of Abuse Questionnaire-Revised (CKAQ-R-III), and a short form (SF) mapped to the learning objectives of Orbit "", 'The evaluation involved 139 students (female\u202f=\u202f78; male\u202f=\u202f61) aged 8-10 years (Mage\u202f=\u202f9.64, SD\u202f=\u202f0.33), from an elementary school in Queensland, Australia', 'children aged 8-10 years']",['play Orbit (n\u202f=\u202f50); ii) play Orbit and CSA lessons (n\u202f=\u202f55); and iii) control'],"['post-test CKAQ scores', 'CKAQ SF scores']","[{'cui': 'C0008062', 'cui_str': 'Sexual Abuse of Child'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C1261558', 'cui_str': 'Abuse prevention'}, {'cui': 'C0562381', 'cui_str': 'Victim of abuse'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0024779', 'cui_str': 'Maps'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0029180', 'cui_str': 'Orbital cavity'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C5191072', 'cui_str': '139'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517449', 'cui_str': '0.33'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0034391', 'cui_str': 'Queensland'}, {'cui': 'C0004340', 'cui_str': 'Australia'}]","[{'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0029180', 'cui_str': 'Orbital cavity'}, {'cui': 'C0008062', 'cui_str': 'Sexual Abuse of Child'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",139.0,0.0282223,"RESULTS Children in the Orbit play, and Orbit play and lesson groups, significantly (p < .001) increased their CKAQ SF scores, whereas those in the control group did not.","[{'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Jones', 'Affiliation': 'School of Social Sciences, University of the Sunshine Coast, Queensland, Australia. Electronic address: cmjones@usc.edu.au.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Scholes', 'Affiliation': 'Institute for Learning Sciences & Teacher Education, Australian Catholic University, Queensland, Australia. Electronic address: laura.scholes@acu.edu.au.'}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Rolfe', 'Affiliation': 'Ecoludology Games, Queensland, Australia. Electronic address: ben@ecoludology.com.'}, {'ForeName': 'Colleen', 'Initials': 'C', 'LastName': 'Stieler-Hunt', 'Affiliation': 'School of Creative Industries, University of the Sunshine Coast, Queensland, Australia. Electronic address: cstieler@usc.edu.au.'}]",Child abuse & neglect,['10.1016/j.chiabu.2020.104569'] 1711,32535341,Effects and safety of body positioning on back pain after transcatheter arterial chemoembolization in people with hepatocellular carcinoma: A randomized controlled study.,"BACKGROUND People with hepatocellular carcinoma who undergo transcatheter arterial chemoembolization usually experience back pain due to lie supine for at least 4 hours to avoid bleeding and hematoma. Body positioning is an effective and safe method for decreasing back pain in people with transfemoral cardiac catheterization; however, its effects and safety among patients with high bleeding tendency are unknown. OBJECTIVE To investigate whether body positioning could decrease back pain without increasing the chance of bleeding after transcatheter arterial chemoembolization. DESIGN A single-blind randomized controlled trial (ClinicalTrials.gov No.: NCT03784469). METHODS A total of 78 people with liver cancer who had undergone chemoembolization through the femoral artery were enrolled. Each person was randomly assigned to either the control or intervention group (each consisted of 39 participants). The control group received the usual care, remaining flat and lying in a supine position, whereas the intervention group had their positions changed in the second and fourth hour after chemoembolization. Participants' pain level was rated by using numerical rating scale -11 (score from 0 to 10), bleeding was measured by using volume of blood (cc.) in gauze and hematoma size in diameter (cm), and satisfaction was self-rated from 1 to 5. Repeated-measure analysis of variance (ANOVA) was used to compare the difference in pain levels over time within each group and independent t test to compare the mean difference of pain between groups at 5 endpoints, both methods with Bonferroni adjustment. Independent t test, chi-squared test, and Fisher's exact test compared postembolization discomfort, puncture sites bleeding, satisfaction between groups. RESULTS Significant changes of pain levels over time in both intervention [F(2.93, 111.20)=7.64, p<.001] and control groups [F(2.66, 101.17)=20.55, p<.001]. The intervention group had a significantly lower mean pain score in the second hour (t = -2.838, p = .006) and fourth hour (t = -4.739, p < .001) when patients turning to the side than did the control group lying supine. Furthermore, patients in the intervention group had significantly higher satisfaction than did those in the control group (t = -2.422, p = .018). No hematoma and significant difference of post-procedural bleeding between groups. CONCLUSION Changing patients' body positions in bed after transcatheter arterial chemoembolization is a safe and effective method of decreasing back pain, and increasing patients' satisfaction, without increasing the complications of bleeding and hematoma. Clinicians should change the positions of people with hepatocellular carcinoma 2 hours after they receive transcatheter arterial chemoembolization.",2020,"-4.739, p < .001) when patients turning to the side than did the control group lying supine.","['people with hepatocellular carcinoma', '78 people with liver cancer who had undergone chemoembolization through the femoral artery were enrolled', 'People with hepatocellular carcinoma who undergo transcatheter arterial chemoembolization usually experience back pain', 'people with transfemoral cardiac catheterization']","['body positioning', 'transcatheter arterial chemoembolization']","['pain level', 'pain levels', 'back pain', 'numerical rating scale -11', 'bleeding', 'mean pain score', 'higher satisfaction']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C2239176', 'cui_str': 'Hepatocellular carcinoma'}, {'cui': 'C0345904', 'cui_str': 'Malignant neoplasm of liver'}, {'cui': 'C0796679', 'cui_str': 'Chemoembolization'}, {'cui': 'C0015801', 'cui_str': 'Structure of femoral artery'}, {'cui': 'C2711393', 'cui_str': 'Transarterial chemoembolization of hepatic artery'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0004604', 'cui_str': 'Backache'}, {'cui': 'C0018795', 'cui_str': 'Cardiac catheterization'}]","[{'cui': 'C1262869', 'cui_str': 'Body position'}, {'cui': 'C2711393', 'cui_str': 'Transarterial chemoembolization of hepatic artery'}]","[{'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0004604', 'cui_str': 'Backache'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",78.0,0.143191,"-4.739, p < .001) when patients turning to the side than did the control group lying supine.","[{'ForeName': 'Kai-Ting', 'Initials': 'KT', 'LastName': 'Chang', 'Affiliation': 'Department of Nursing, National Taiwan University Hospital, No.7, Chung Shan S. Rd., Taipei City, 10002, Taiwan. Electronic address: kaiting105866@gmail.com.'}, {'ForeName': 'Chun-Jen', 'Initials': 'CJ', 'LastName': 'Liu', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Internal Medicine, National, Taiwan University Hospital, No.7, Chung Shan S. Rd., Taipei City, 10002, Taiwan. Electronic address: cjliu@ntu.edu.tw.'}, {'ForeName': 'Hsiu-Ting', 'Initials': 'HT', 'LastName': 'Tsai', 'Affiliation': 'Post-Baccalaureate Program in Nursing, Taipei Medical University, No. 250 Wu-Xing Street, Taipei City, 110, Taiwan. Electronic address: hsiuting@tmu.edu.tw.'}, {'ForeName': 'Tse-Pin', 'Initials': 'TP', 'LastName': 'Hsu', 'Affiliation': 'Department of Nursing, National Taiwan University Hospital, Chung Shan S. Rd., Taipei City, 10002, Taiwan. Electronic address: 021077@ntuh.gov.tw.'}, {'ForeName': 'Po-Ting', 'Initials': 'PT', 'LastName': 'Chen', 'Affiliation': 'Department of Medical Imaging, National Taiwan University Hospital, Chung Shan S. Rd., Taipei City, 10002, Taiwan. Electronic address: nate770407@gmail.com.'}, {'ForeName': 'Sophia H', 'Initials': 'SH', 'LastName': 'Hu', 'Affiliation': 'School of Nursing, College of Nursing, National Yang-Ming University, No.155, Sec.2, Li-Nong Street, Taipei City, 112, Taiwan. Electronic address: sophiahu@ym.edu.tw.'}]",International journal of nursing studies,['10.1016/j.ijnurstu.2020.103641'] 1712,32535786,The Protective Effects of Butorphanol on Pulmonary Function of Patients with Obesity Undergoing Laparoscopic Bariatric Surgery: a Double-Blind Randomized Controlled Trial.,"BACKGROUND Obesity is a risk factor for postoperative pulmonary complications (PPCs). Recent studies have reported the pulmonary protective role of the kappa opioid receptor (KOR). Butorphanol is a narcotic with strong KOR agonist action, and the role in pulmonary protection is uncertain. Here, we hypothesized that butorphanol exerts protective effects on pulmonary function in patients with obesity undergoing laparoscopic bariatric surgery. METHODS Patients with a body mass index ≥ 30 kg/m 2 scheduled for laparoscopic bariatric surgery were randomized to receive butorphanol or normal saline. Butorphanol was administered as an initial loading dose of 10 μg/kg at 5 min before induction followed by 5 μg/(kg h) during surgery. The primary outcome was arterial-alveolar oxygen tension ratio (a/A ratio). Secondary outcomes included other pulmonary variables, biomarkers reflecting pulmonary injury, and incidence of PPCs within 7 days after surgery. RESULTS Patients in the butorphanol group had a significantly higher a/A ratio at 1 h after the operation began (68 ± 7 vs. 55 ± 8, P < 0.001), end of the operation (73 ± 8 vs. 59 ± 7, P < 0.001), and 1 h after extubation (83 ± 9 vs. 70 ± 5, P < 0.001) compared with those in the control group. In addition, in the butorphanol group, dead space to tidal volume ratios were significantly lower than those in the control group at the same time points (all P < 0.001). In the control group, the levels of biomarkers reflecting pulmonary injury were significantly higher than those in the butorphanol group at 3 h, 6 h, 12 h, and 24 h postoperatively (P < 0.001). The incidence of PPCs was similar in both groups. CONCLUSION Butorphanol administration protected pulmonary function by improving oxygenation and reducing dead space ventilation in patients with obesity undergoing laparoscopic bariatric surgery. Butorphanol may therefore provide clinical benefits in patients with obesity.",2020,"In the control group, the levels of biomarkers reflecting pulmonary injury were significantly higher than those in the butorphanol group at 3 h, 6 h, 12 h, and 24 h postoperatively (P < 0.001).","['m 2 scheduled for laparoscopic bariatric surgery', 'Patients with a body mass index ≥', 'patients with obesity undergoing laparoscopic bariatric surgery', 'patients with obesity', 'Patients with Obesity Undergoing Laparoscopic Bariatric Surgery']","['butorphanol', 'Butorphanol', 'butorphanol or normal saline']","['Pulmonary Function', 'arterial-alveolar oxygen tension ratio (a/A ratio', 'pulmonary variables, biomarkers reflecting pulmonary injury, and incidence of PPCs within 7\xa0days after surgery', 'dead space ventilation', 'pulmonary function', 'dead space to tidal volume ratios', 'incidence of PPCs', 'levels of biomarkers reflecting pulmonary injury']","[{'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C1456587', 'cui_str': 'Metabolic surgery'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0006491', 'cui_str': 'Butorphanol'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}]","[{'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0202155', 'cui_str': 'Oxygen measurement, partial pressure, arterial'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0558058', 'cui_str': 'Reflecting'}, {'cui': 'C0273115', 'cui_str': 'Injury of lung'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0040210', 'cui_str': 'Tidal volume'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.433438,"In the control group, the levels of biomarkers reflecting pulmonary injury were significantly higher than those in the butorphanol group at 3 h, 6 h, 12 h, and 24 h postoperatively (P < 0.001).","[{'ForeName': 'Xiu-Li', 'Initials': 'XL', 'LastName': 'Wang', 'Affiliation': 'Jiangsu Province Key Laboratory of Anesthesiology, Xuzhou Medical University, Xuzhou, Jiangsu, China.'}, {'ForeName': 'Si', 'Initials': 'S', 'LastName': 'Zeng', 'Affiliation': ""Department of Anesthesiology, Sichuan Academy of Medical Science & Sichuan Provincial People's Hospital, University of Electronic Science and Technology of China, Chengdu, Sichuan, China.""}, {'ForeName': 'Xiao-Xiao', 'Initials': 'XX', 'LastName': 'Li', 'Affiliation': 'Jiangsu Province Key Laboratory of Anesthesiology, Xuzhou Medical University, Xuzhou, Jiangsu, China.'}, {'ForeName': 'Ye', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'Jiangsu Province Key Laboratory of Anesthesiology, Xuzhou Medical University, Xuzhou, Jiangsu, China.'}, {'ForeName': 'Xing-He', 'Initials': 'XH', 'LastName': 'Wang', 'Affiliation': 'Jiangsu Province Key Laboratory of Anesthesiology, Xuzhou Medical University, Xuzhou, Jiangsu, China.'}, {'ForeName': 'Tong', 'Initials': 'T', 'LastName': 'Li', 'Affiliation': 'Jiangsu Province Key Laboratory of Anesthesiology, Xuzhou Medical University, Xuzhou, Jiangsu, China.'}, {'ForeName': 'Su', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': 'Jiangsu Province Key Laboratory of Anesthesiology, Xuzhou Medical University, Xuzhou, Jiangsu, China. w15996933165@163.com.'}]",Obesity surgery,['10.1007/s11695-020-04755-2'] 1713,32510130,Kisspeptin and neurokinin B interactions in modulating gonadotropin secretion in women with polycystic ovary syndrome.,"STUDY QUESTION What is the role of the hypothalamic neuropeptide neurokinin B (NKB) and its interaction with kisspeptin on GnRH/LH secretion in women with polycystic ovary syndrome (PCOS)? SUMMARY ANSWER Administration of neurokinin 3 receptor antagonist (NK3Ra) for 7 days reduced LH and FSH secretion and LH pulse frequency in women with PCOS, whilst the stimulatory LH response to kisspeptin-10 was maintained. WHAT IS KNOWN ALREADY PCOS is characterized by abnormal GnRH/LH secretion. NKB and kisspeptin are master regulators of GnRH/LH secretion, but their role in PCOS is unclear. STUDY DESIGN, SIZE, DURATION The NK3Ra MLE4901, 40 mg orally twice a day, was administered to women with PCOS for 7 days (n = 8) (vs no treatment, n = 7). On the last day of NK3Ra administration or the equivalent day in those not treated, women were randomized to 7-h kisspeptin-10 (4 µg/kg/h i.v.) or vehicle infusion. This was repeated with the alternate infusion in a subsequent cycle. PARTICIPANTS/MATERIALS, SETTING, METHODS Subjects were women with PCOS, studied in a Clinical Research Facility. Reproductive hormones were measured before and after NK3Ra administration. On the last day of NK3Ra administration (or the equivalent cycle day in untreated women), all women attended for an 8-h frequent blood sampling to allow analysis of the pulsatile LH secretion. MAIN RESULTS AND THE ROLE OF CHANCE NK3Ra reduced LH secretion (4.0 ± 0.4 vs 6.5 ± 0.8 IU/l, P < 0.05) and pulse frequency (0.5 ± 0.1 vs 0.8 ± 0.1 pulses/h, P < 0.05); FSH secretion was also reduced (2.0 ± 0.3 vs 2.5 ± 0.4 IU/l, P < 0.05). Without NK3Ra pre-treatment, kisspeptin-10 increased LH secretion (5.2 ± 0.5 to 7.8 ± 1.0 IU/L, P < 0.05), with a positive relationship to oestradiol concentrations (r2 = 0.59, P < 0.05). After NK3Ra administration, the LH response to kisspeptin-10 was preserved (vehicle 3.5 ± 0.3 vs 9.0 ± 2.2 IU/l with kisspeptin-10, P < 0.05), but the positive correlation with oestradiol concentrations was abolished (r2 = 0.07, ns. after NK3Ra). FSH secretion was increased by kisspeptin-10 after NK3Ra treatment, but not without NK3Ra treatment. LIMITATIONS, REASONS FOR CAUTION The study did not explore the dose relationship of the effect of NK3R antagonism. The impact of obesity or other aspects of the variability of the PCOS phenotype was not studied due to the small number of subjects. WIDER IMPLICATIONS OF THE FINDINGS These data demonstrate the interactive regulation of GnRH/LH secretion by NKB and kisspeptin in PCOS, and that the NKB system mediates aspects of oestrogenic feedback. STUDY FUNDING/COMPETING INTEREST(S) Wellcome Trust through Scottish Translational Medicine and Therapeutics Initiative (102419/Z/13/A) and MRC grants (G0701682 to R.P.M. and R.A.A.) and MR/N022556/1 to the MRC Centre for Reproductive Health. This work was performed within the Edinburgh Clinical Research Facility. J.T.G. has undertaken consultancy work for AstraZeneca and Takeda Pharmaceuticals and is an employee of Boehringer Ingelheim. R.P.M. has consulted for Ogeda and was CEO of Peptocrine. R.A.A. has undertaken consultancy work for Merck, Ferring, NeRRe Therapeutics and Sojournix Inc. J.D.V. and K.S. have nothing to disclose. TRIAL REGISTRATION NUMBER N/A.",2020,"FSH secretion was increased by kisspeptin-10 after NK3Ra treatment, but not without NK3Ra treatment. ","['women with polycystic ovary syndrome (PCOS', 'Subjects were women with PCOS, studied in a Clinical Research Facility', 'women with PCOS', 'women with polycystic ovary syndrome']","['hypothalamic neuropeptide neurokinin B (NKB', 'Kisspeptin and neurokinin B interactions', 'NK3Ra', 'NK3Ra MLE4901', 'kisspeptin']","['pulse frequency', 'LH response to kisspeptin-10', 'NK3Ra reduced LH secretion', 'FSH secretion', 'LH and FSH secretion and LH pulse frequency', 'oestradiol concentrations', 'Reproductive hormones', 'positive correlation with oestradiol concentrations', 'LH secretion']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032460', 'cui_str': 'Polycystic ovary syndrome'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0020663', 'cui_str': 'Hypothalamic structure'}, {'cui': 'C0027895', 'cui_str': 'Neuropeptide'}, {'cui': 'C0027847', 'cui_str': 'Neurokinin beta'}, {'cui': 'C0540309', 'cui_str': 'KISS1 protein, human'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C0068603', 'cui_str': 'Neuromedin K Receptor'}, {'cui': 'C0231491', 'cui_str': 'Antagonist muscle action'}]","[{'cui': 'C0034107', 'cui_str': 'Pulse taking'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C1721258', 'cui_str': 'kisspeptin-10 protein, human'}, {'cui': 'C0068603', 'cui_str': 'Neuromedin K Receptor'}, {'cui': 'C0231491', 'cui_str': 'Antagonist muscle action'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0036536', 'cui_str': 'secretion'}, {'cui': 'C0202022', 'cui_str': 'Follicle stimulating hormone measurement'}, {'cui': 'C0014912', 'cui_str': 'Estradiol'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C1167871', 'cui_str': 'Reproductive hormone'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0010101', 'cui_str': 'Correlation Studies'}]",,0.109421,"FSH secretion was increased by kisspeptin-10 after NK3Ra treatment, but not without NK3Ra treatment. ","[{'ForeName': 'Karolina', 'Initials': 'K', 'LastName': 'Skorupskaite', 'Affiliation': ""MRC Centre for Reproductive Health, The Queen's Medical Research Institute, University of Edinburgh, 47 Little France Crescent, Edinburgh EH16 4TJ, UK.""}, {'ForeName': 'Jyothis T', 'Initials': 'JT', 'LastName': 'George', 'Affiliation': 'Warwick Medical School, Coventry CV4 7AL, UK.'}, {'ForeName': 'Johannes D', 'Initials': 'JD', 'LastName': 'Veldhuis', 'Affiliation': 'Endocrine Research Unit, Center for Translational Science Activities, Mayo Clinic, Rochester, MN 55905, USA.'}, {'ForeName': 'Robert P', 'Initials': 'RP', 'LastName': 'Millar', 'Affiliation': 'Centre for Neuroendocrinology and Mammal Research Institute, University of Pretoria, 0028 Pretoria, South Africa.'}, {'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Anderson', 'Affiliation': ""MRC Centre for Reproductive Health, The Queen's Medical Research Institute, University of Edinburgh, 47 Little France Crescent, Edinburgh EH16 4TJ, UK.""}]","Human reproduction (Oxford, England)",['10.1093/humrep/deaa104'] 1714,32505785,Effect of a 10-month residential multidisciplinary weight loss intervention on food reward in adolescents with obesity.,"BACKGROUND While multidisciplinary weight loss (WL) programs have been suggested to improve the sensitivity of appetite control system, this study examined for the first time the effect of a specific multidisciplinary intervention on the hedonic aspects of food intake in adolescents with obesity. STUDY DESIGN Twenty-four adolescents (11-15 years) with obesity (mean BMI: 35.7 ± 4.5 kg/m 2 ; BMI percentile: 98.7 ± 0.5) took part in a 10-month inpatient WL program, which included physical activity, nutritional education and psychological support. Height, weight, body composition, food reward (pre- and post-meal), ad libitum energy intake, appetite sensations and eating behavior traits were assessed at baseline, 5 months and at the end of the 10-month intervention. Analyses were conducted with linear mixed models and paired t-tests. RESULTS The mean WL was 8.9 ± 6.9 kg. Appetite sensations and pre-meal hedonic ratings of liking for all food categories (HF: high-fat; LF: low-fat; SA: savory; SW: sweet) increased after 5 months (fasting hunger, p = 0.02; fasting desire to eat, p = 0.01; daily hunger, p = 0.001; pre-meal liking for HFSA, p = 0.03; LFSA, p = 0.04; HFSW, p = 0.009; LFSW, p = 0.005). In contrast, appetite sensations (fasting and daily), emotional eating (p < 0.001), uncontrolled eating (p = 0.009), and pre-meal explicit liking (for all food categories) decreased between months 5 and 10. Post-meal liking for HFSA (p < 0.001), LFSA (p = 0.002), HFSW (p = 0.02) and LFSW (p < 0.001) decreased between baseline and month 5 and remained unchanged between months 5 and 10. CONCLUSION These findings suggest that adaptive mechanisms to WL occurring in the short-to-medium term are attenuated in the longer term with the persistence of WL. These results indicate improvements in the reward response to food in adolescents with obesity and may contribute to the beneficial effect of multicomponent WL interventions in this population. Future studies are required to confirm these findings and elucidate underlying mechanisms.",2020,Post-meal liking for HFSA (p<0.001),"['adolescents with obesity', 'Twenty-four adolescents (11-15 years) with obesity']",['residential multidisciplinary weight loss intervention'],"['Height, weight, body composition, food reward (pre- and post-meal), ad libitum energy intake, appetite sensations and eating behavior traits', 'appetite sensations (fasting and daily), emotional eating (p<0.001), uncontrolled eating (p=0.009), and pre-meal explicit liking', 'HFSW', 'Appetite sensations and pre-meal hedonic ratings of liking']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0242479', 'cui_str': 'Interdisciplinary Studies'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0035397', 'cui_str': 'Rewards'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0015745', 'cui_str': 'Eating Behavior'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C1998602', 'cui_str': 'Meals'}]",24.0,0.0263658,Post-meal liking for HFSA (p<0.001),"[{'ForeName': 'Maud', 'Initials': 'M', 'LastName': 'Miguet', 'Affiliation': 'Clermont Auvergne University, EA 3533, Laboratory of the Metabolic Adaptations to Exercise under Physiological and Pathological Conditions (AME2P), Clermont-Ferrand, France. Electronic address: maud.miguet@neuro.uu.se.'}, {'ForeName': 'Kristine', 'Initials': 'K', 'LastName': 'Beaulieu', 'Affiliation': 'School of Psychology, Faculty of Medicine and Health, University of Leeds, Leeds, LS2 9JT, UK.'}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Fillon', 'Affiliation': 'Clermont Auvergne University, EA 3533, Laboratory of the Metabolic Adaptations to Exercise under Physiological and Pathological Conditions (AME2P), Clermont-Ferrand, France.'}, {'ForeName': 'Marwa', 'Initials': 'M', 'LastName': 'Khammassi', 'Affiliation': 'Clermont Auvergne University, EA 3533, Laboratory of the Metabolic Adaptations to Exercise under Physiological and Pathological Conditions (AME2P), Clermont-Ferrand, France.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Masurier', 'Affiliation': 'UGECAM Nutrition Obesity Ambulatory Hospital, Clermont-Ferrand, France.'}, {'ForeName': 'Céline', 'Initials': 'C', 'LastName': 'Lambert', 'Affiliation': 'Clermont-Ferrand University Hospital, Biostatistics Unit (DRCI), Clermont-Ferrand, France.'}, {'ForeName': 'Martine', 'Initials': 'M', 'LastName': 'Duclos', 'Affiliation': 'Department of Sport Medicine and Functional Explorations, Clermont-Ferrand University Hospital, G. Montpied Hospital, Clermont-Ferrand, France.'}, {'ForeName': 'Yves', 'Initials': 'Y', 'LastName': 'Boirie', 'Affiliation': 'Department of Human Nutrition, Clermont-Ferrand University Hospital, G. Montpied Hospital, Clermont-Ferrand, France.'}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'Finlayson', 'Affiliation': 'School of Psychology, Faculty of Medicine and Health, University of Leeds, Leeds, LS2 9JT, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Thivel', 'Affiliation': 'Clermont Auvergne University, EA 3533, Laboratory of the Metabolic Adaptations to Exercise under Physiological and Pathological Conditions (AME2P), Clermont-Ferrand, France.'}]",Physiology & behavior,['10.1016/j.physbeh.2020.112996'] 1715,32505810,Improving Oral Health and Modulating the Oral Microbiome to Reduce Bloodstream Infections from Oral Organisms in Pediatric and Young Adult Hematopoietic Stem Cell Transplantation Recipients: A Randomized Controlled Trial.,"Bloodstream infections (BSIs) from oral organisms are a significant cause of morbidity and mortality in hematopoietic stem cell transplantation (HSCT) recipients. There are no proven strategies to decrease BSIs from oral organisms. The aim of this study was to evaluate the impact of daily xylitol wipes in improving oral health, decreasing BSI from oral organisms, and modulating the oral microbiome in pediatric HSCT recipients. This was a single-center 1:1 randomized controlled trial in pediatric HSCT recipients age >2 years. Age-matched healthy children were enrolled to compare the oral microbiome. The oral hygiene standard of care (SOC) group continued to receive the standard oral hygiene regimen. The xylitol group received daily oral xylitol wipes (with .7 g xylitol) in addition to the SOC. The intervention started from the beginning of the transplantation chemotherapy regimen and extended to 28 days following transplantation. The primary outcome was oral health at interval time points, and secondary outcomes included BSIs from oral organisms in the first 30 days following transplantation, oral microbiome abundance, and diversity and oral pathogenic organism abundance. The study was closed early due to efficacy after an interim analysis of the first 30 HSCT recipients was performed (SOC group, n = 16; xylitol group, n = 14). The xylitol group had a significantly lower rate of gingivitis at days 7, 14, and 28 following transplantation (P = .031, .0039, and .0005, respectively); oral plaque at days 7 and 14 (P = .045 and .0023, respectively); and oral ulcers >10 mm at day 14 (P = .049) compared with the SOC group. The xylitol group had no BSI from oral organisms compared with the SOC group, which had 4 (P = .04). The xylitol group had significantly lower abundance of potential BSI pathogens, such as Staphylococcus aureus (P = .036), Klebsiella pneumoniae (P = .033), and Streptococcus spp (P = .011) at the day after transplantation compared with the SOC group. Healthy children and young adults had significantly increased oral microbiome diversity compared with all HSCT recipients (P < .001). The addition of xylitol to standard oral care significantly improves oral health, decreases BSI from oral organisms, and decreases the abundance of pathogenic oral organisms in pediatric and young adult HSCT recipients.",2020,"The xylitol group had a significantly lower rate of gingivitis at days 7, 14, and 28 following transplantation (p=0.031, p=0.0039, p=0.0005); oral plaque at days 7 and 14 following transplantation (p=0.045, p=0.0023); and oral ulcers greater than 10 mm at day 14 (p=0.049) compared to the SOC group.","['hematopoietic stem cell transplant (HSCT) recipients', 'Age matched healthy children', 'pediatric HSCT recipients older than 2 years', 'Healthy children and young adults', 'pediatric and young adult HSCT recipients', 'Pediatric and Young Adult Hematopoietic Stem Cell Transplant Recipients', 'pediatric HSCT recipients']","['daily oral xylitol wipes (with 0.7gm xylitol', 'oral hygiene standard of care (SOC', 'xylitol']","['Klebsiella pneumoniae', 'oral health', 'oral ulcers', 'rate of gingivitis', 'oral microbiome diversity', 'abundance of potential BSI pathogens such as Staphylococcus aureus', 'oral plaque', 'oral health at interval time points, and secondary outcomes included blood stream infections from oral organisms in the first 30 days following transplantation, oral microbiome abundance, and diversity and oral pathogenic organism abundance', 'pathogenic oral organism abundance']","[{'cui': 'C0472699', 'cui_str': 'Hemopoietic stem cell transplant'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0686744', 'cui_str': 'Well child'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0043369', 'cui_str': 'Xylitol'}, {'cui': 'C0029164', 'cui_str': 'Dental Hygiene'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}]","[{'cui': 'C0001699', 'cui_str': 'Klebsiella pneumoniae'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0149745', 'cui_str': 'Ulcer of mouth'}, {'cui': 'C1956108', 'cui_str': 'Microbiome'}, {'cui': 'C2316160', 'cui_str': 'Infection of bloodstream'}, {'cui': 'C0450254', 'cui_str': 'Pathogenic organism'}, {'cui': 'C0038172', 'cui_str': 'Staphylococcus aureus'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0442540', 'cui_str': 'Stream'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0029235', 'cui_str': 'Organism'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}]",30.0,0.10366,"The xylitol group had a significantly lower rate of gingivitis at days 7, 14, and 28 following transplantation (p=0.031, p=0.0039, p=0.0005); oral plaque at days 7 and 14 following transplantation (p=0.045, p=0.0023); and oral ulcers greater than 10 mm at day 14 (p=0.049) compared to the SOC group.","[{'ForeName': 'Priscila', 'Initials': 'P', 'LastName': 'Badia', 'Affiliation': ""Division of Bone Marrow Transplant and Immune Deficiency, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio; Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, Ohio; Department of Hematology and Oncology, Phoenix Children's Hospital, Phoenix, Arizona. Electronic address: pbadia@phoenixchildrens.com.""}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Andersen', 'Affiliation': ""Department of Hematology and Oncology, Phoenix Children's Hospital, Phoenix, Arizona; Division of Infectious Diseases, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Haslam', 'Affiliation': ""Department of Hematology and Oncology, Phoenix Children's Hospital, Phoenix, Arizona; Division of Infectious Diseases, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio.""}, {'ForeName': 'Adam S', 'Initials': 'AS', 'LastName': 'Nelson', 'Affiliation': ""Department of Hematology and Oncology, Phoenix Children's Hospital, Phoenix, Arizona; Division of Infectious Diseases, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio.""}, {'ForeName': 'Abigail R', 'Initials': 'AR', 'LastName': 'Pate', 'Affiliation': ""Division of Bone Marrow Transplant and Immune Deficiency, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio.""}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Golkari', 'Affiliation': ""Division of Pediatric Dentistry, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio.""}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Teusink-Cross', 'Affiliation': ""Division of Bone Marrow Transplant and Immune Deficiency, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio.""}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Flesch', 'Affiliation': ""Division of Bone Marrow Transplant and Immune Deficiency, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio.""}, {'ForeName': 'Ashely', 'Initials': 'A', 'LastName': 'Bedel', 'Affiliation': ""Division of Bone Marrow Transplant and Immune Deficiency, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio.""}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Hickey', 'Affiliation': ""Division of Bone Marrow Transplant and Immune Deficiency, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio.""}, {'ForeName': 'Kathi', 'Initials': 'K', 'LastName': 'Kramer', 'Affiliation': ""Division of Bone Marrow Transplant and Immune Deficiency, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio.""}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Lane', 'Affiliation': ""Division of Bone Marrow Transplant and Immune Deficiency, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio.""}, {'ForeName': 'Stella M', 'Initials': 'SM', 'LastName': 'Davies', 'Affiliation': ""Division of Bone Marrow Transplant and Immune Deficiency, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio; Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, Ohio.""}, {'ForeName': 'Sarat', 'Initials': 'S', 'LastName': 'Thikkurissy', 'Affiliation': ""Division of Pediatric Dentistry, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio.""}, {'ForeName': 'Christopher E', 'Initials': 'CE', 'LastName': 'Dandoy', 'Affiliation': ""Division of Bone Marrow Transplant and Immune Deficiency, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio; Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, Ohio.""}]",Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation,['10.1016/j.bbmt.2020.05.019'] 1716,32512272,Durvalumab vs placebo consolidation therapy after chemoradiotherapy in stage III non-small-cell lung cancer: An updated PACIFIC trial-based cost-effectiveness analysis.,"INTRODUCTION Recently updated three-year survival data from the PACIFIC trial showed that durvalumab consolidation therapy improved OS rates versus placebo for patients with unresectable stage III non-small cell lung cancer (NSCLC) after chemoradiotherapy. Considering the impact of the high cost of durvalumab, its cost-effectiveness should be updated to see if its cost-effectiveness has changed from the US payers' perspective. METHODS A comprehensive Markov model was used to evaluate mean lifetime costs and effectiveness of first-line durvalumab consolidation therapy versus placebo for patients with unresectable stage III NSCLC imputing updated survival and quality-of-life data from the PACIFIC trial. The main endpoints include total costs, life years (LYs), quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratios (ICERs). One-way, two-way, and probabilistic sensitivity analyses were conducted to access the uncertainty in the variables. We also considered durvalumab cost-effectiveness in the subgroups. RESULTS Durvalumab consolidation therapy resulted in additional 1.34 LYs and 1.01 QALYs, resulting in an ICER of $138,920 per QALY versus the placebo treatment. One-way sensitivity analysis revealed that the utility values of two treatments, body weight, and unit cost of durvalumab have the greatest influence on the result. Subgroup analyses demonstrated that durvalumab was more cost effective for patients with non-squamous-cell lung cancer, followed by 25% or greater PD-L1 expression. Probabilistic sensitivity analysis showed that the probability of durvalumab being cost-effective versus the placebo is 62.6% at a willingness-to-pay (WTP) of $150,000 per QALY CONCLUSION: Our analyses demonstrated that receiving durvalumab consolidation therapy was more cost-effective than placebo at a WTP threshold of $150,000. These results can be of use to US practitioners in the application of durvalumab and for durvalumab prescription and reimbursement policies.",2020,"Subgroup analyses demonstrated that durvalumab was more cost effective for patients with non-squamous-cell lung cancer, followed by 25% or greater PD-L1 expression.","['patients with unresectable stage III non-small cell lung cancer (NSCLC) after chemoradiotherapy', 'patients with unresectable stage III NSCLC imputing updated survival and quality-of-life data from the PACIFIC trial', 'stage III non-small-cell lung cancer']","['durvalumab consolidation therapy', 'durvalumab', 'Durvalumab vs placebo consolidation therapy after chemoradiotherapy', 'placebo']","['total costs, life years (LYs), quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratios (ICERs', 'mean lifetime costs and effectiveness', 'OS rates', 'cost effective']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0278506', 'cui_str': 'Non-small cell lung cancer stage III'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C4055109', 'cui_str': 'durvalumab'}, {'cui': 'C0521530', 'cui_str': 'Lung consolidation'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",,0.0947434,"Subgroup analyses demonstrated that durvalumab was more cost effective for patients with non-squamous-cell lung cancer, followed by 25% or greater PD-L1 expression.","[{'ForeName': 'Jiaqi', 'Initials': 'J', 'LastName': 'Han', 'Affiliation': 'Department of Head and Neck Oncology and Department of Radiation Oncology, Cancer Center and State Key Laboratory of Biotherapy, West China Hospital, Sichuan University, Chengdu 610041, PR China.'}, {'ForeName': 'Kun', 'Initials': 'K', 'LastName': 'Tian', 'Affiliation': 'Department of Urology, Institute of Urology, West China Hospital, Sichuan University, Chengdu 610041, PR China.'}, {'ForeName': 'Jiangping', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': 'Department of Head and Neck Oncology and Department of Radiation Oncology, Cancer Center and State Key Laboratory of Biotherapy, West China Hospital, Sichuan University, Chengdu 610041, PR China.'}, {'ForeName': 'Youling', 'Initials': 'Y', 'LastName': 'Gong', 'Affiliation': 'Department of Thoracic Oncology and State Key Laboratory of Biotherapy, Cancer Center, West China Hospital, Sichuan University, Chengdu, Sichuan 610041, PR China. Electronic address: gongyouling@hotmail.com.'}]","Lung cancer (Amsterdam, Netherlands)",['10.1016/j.lungcan.2020.05.011'] 1717,32512291,"Rationale and design of the PRAETORIAN-COVID trial: A double-blind, placebo-controlled randomized clinical trial with valsartan for PRevention of Acute rEspiraTORy dIstress syndrome in hospitAlized patieNts with SARS-COV-2 Infection Disease.","There is much debate on the use of angiotensin receptor blockers (ARBs) in severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2)-infected patients. Although it has been suggested that ARBs might lead to a higher susceptibility and severity of SARS-CoV-2 infection, experimental data suggest that ARBs may reduce acute lung injury via blocking angiotensin-II-mediated pulmonary permeability, inflammation, and fibrosis. However, despite these hypotheses, specific studies on ARBs in SARS-CoV-2 patients are lacking. METHODS: The PRAETORIAN-COVID trial is a multicenter, double-blind, placebo-controlled 1:1 randomized clinical trial in adult hospitalized SARS-CoV-2-infected patients (n = 651). The primary aim is to investigate the effect of the ARB valsartan compared to placebo on the composite end point of admission to an intensive care unit, mechanical ventilation, or death within 14 days of randomization. The active-treatment arm will receive valsartan in a dosage titrated to blood pressure up to a maximum of 160 mg bid, and the placebo arm will receive matching placebo. Treatment duration will be 14 days, or until the occurrence of the primary end point or until hospital discharge, if either of these occurs within 14 days. The trial is registered at clinicaltrials.gov (NCT04335786, 2020). SUMMARY: The PRAETORIAN-COVID trial is a double-blind, placebo-controlled 1:1 randomized trial to assess the effect of valsartan compared to placebo on the occurrence of ICU admission, mechanical ventilation, and death in hospitalized SARS-CoV-2-infected patients. The results of this study might impact the treatment of SARS-CoV-2 patients globally.",2020,There is much debate on the use of angiotensin receptor blockers (ARBs) in severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2)-infected patients.,"['hospitalized SARS-CoV-2-infected patients', 'hospitAlized patieNts with SARS-COV-2 Infection Disease', 'severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2)-infected patients', 'adult hospitalized SARS-CoV-2-infected patients (n = 651']","['valsartan', 'ARB valsartan', 'angiotensin receptor blockers (ARBs', 'placebo arm will receive matching placebo', 'placebo']","['occurrence of ICU admission, mechanical ventilation, and death']","[{'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0216784', 'cui_str': 'valsartan'}, {'cui': 'C0521942', 'cui_str': 'Angiotensin II receptor antagonist'}, {'cui': 'C0034787', 'cui_str': 'Angiotensin receptor'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]","[{'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",,0.592181,There is much debate on the use of angiotensin receptor blockers (ARBs) in severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2)-infected patients.,"[{'ForeName': 'D H Frank', 'Initials': 'DHF', 'LastName': 'Gommans', 'Affiliation': 'Department of Cardiology, Radboudumc, Nijmegen, the Netherlands. Electronic address: frank.gommans@radboudumc.nl.'}, {'ForeName': 'Joris', 'Initials': 'J', 'LastName': 'Nas', 'Affiliation': 'Department of Cardiology, Radboudumc, Nijmegen, the Netherlands.'}, {'ForeName': 'Sara-Joan', 'Initials': 'SJ', 'LastName': 'Pinto-Sietsma', 'Affiliation': 'Department of Vascular Medicine, Amsterdam UMC, Amsterdam, the Netherlands.'}, {'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'Koop', 'Affiliation': 'Department of Cardiology, Radboudumc, Nijmegen, the Netherlands.'}, {'ForeName': 'Regina E', 'Initials': 'RE', 'LastName': 'Konst', 'Affiliation': 'Department of Cardiology, Radboudumc, Nijmegen, the Netherlands.'}, {'ForeName': 'Frans', 'Initials': 'F', 'LastName': 'Mensink', 'Affiliation': 'Department of Cardiology, Radboudumc, Nijmegen, the Netherlands.'}, {'ForeName': 'Goaris W A', 'Initials': 'GWA', 'LastName': 'Aarts', 'Affiliation': 'Department of Cardiology, Radboudumc, Nijmegen, the Netherlands.'}, {'ForeName': 'Lara S F', 'Initials': 'LSF', 'LastName': 'Konijnenberg', 'Affiliation': 'Department of Cardiology, Radboudumc, Nijmegen, the Netherlands.'}, {'ForeName': 'Kimberley', 'Initials': 'K', 'LastName': 'Cortenbach', 'Affiliation': 'Department of Cardiology, Radboudumc, Nijmegen, the Netherlands.'}, {'ForeName': 'Dominique V M', 'Initials': 'DVM', 'LastName': 'Verhaert', 'Affiliation': 'Department of Cardiology, Radboudumc, Nijmegen, the Netherlands; Department of Cardiology, Cardiovascular Research Institute Maastricht (CARIM), Maastricht University Medical Center (MUMC+), Maastricht, the Netherlands.'}, {'ForeName': 'Jos', 'Initials': 'J', 'LastName': 'Thannhauser', 'Affiliation': 'Department of Cardiology, Radboudumc, Nijmegen, the Netherlands.'}, {'ForeName': 'Jan-Quinten', 'Initials': 'JQ', 'LastName': 'Mol', 'Affiliation': 'Department of Cardiology, Radboudumc, Nijmegen, the Netherlands.'}, {'ForeName': 'Maxim J P', 'Initials': 'MJP', 'LastName': 'Rooijakkers', 'Affiliation': 'Department of Cardiology, Radboudumc, Nijmegen, the Netherlands.'}, {'ForeName': 'Jacqueline L', 'Initials': 'JL', 'LastName': 'Vos', 'Affiliation': 'Department of Cardiology, Radboudumc, Nijmegen, the Netherlands.'}, {'ForeName': 'Anouke', 'Initials': 'A', 'LastName': 'van Rumund', 'Affiliation': 'Department of Neurology, Radboudumc, Nijmegen, the Netherlands.'}, {'ForeName': 'Priya', 'Initials': 'P', 'LastName': 'Vart', 'Affiliation': 'Department of Biostatistics, Radboudumc, Nijmegen, the Netherlands.'}, {'ForeName': 'Robert-Jan', 'Initials': 'RJ', 'LastName': 'Hassing', 'Affiliation': 'Department of Internal Medicine, Rijnstate Hospital, Arnhem, the Netherlands.'}, {'ForeName': 'Jan-Hein', 'Initials': 'JH', 'LastName': 'Cornel', 'Affiliation': 'Department of Cardiology, Radboudumc, Nijmegen, the Netherlands; Department of Cardiology, Noordwest Ziekenhuisgroep, Alkmaar, the Netherlands.'}, {'ForeName': 'C Peter C', 'Initials': 'CPC', 'LastName': 'de Jager', 'Affiliation': ""Department of Intensive Care, Jeroen Bosch Hospital, 's-Hertogenbosch, the Netherlands.""}, {'ForeName': 'Michel M', 'Initials': 'MM', 'LastName': 'van den Heuvel', 'Affiliation': 'Department of Pulmonary diseases, Radboudumc, Nijmegen, the Netherlands.'}, {'ForeName': 'Hans G', 'Initials': 'HG', 'LastName': 'van der Hoeven', 'Affiliation': 'Department of Intensive Care, Radboudumc, Nijmegen, the Netherlands.'}, {'ForeName': 'Annelies', 'Initials': 'A', 'LastName': 'Verbon', 'Affiliation': 'Department of Medical Microbiology and Infectious Diseases, ErasmusMC, Rotterdam, the Netherlands.'}, {'ForeName': 'Yigal M', 'Initials': 'YM', 'LastName': 'Pinto', 'Affiliation': 'Department of Cardiology, Amsterdam UMC, Amsterdam, the Netherlands.'}, {'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'van Royen', 'Affiliation': 'Department of Cardiology, Radboudumc, Nijmegen, the Netherlands.'}, {'ForeName': 'Roland R J', 'Initials': 'RRJ', 'LastName': 'van Kimmenade', 'Affiliation': 'Department of Cardiology, Radboudumc, Nijmegen, the Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'Peter W', 'Initials': 'PW', 'LastName': 'de Leeuw', 'Affiliation': 'Department of Internal Medicine, Maastricht UMC, Maastricht, the Netherlands.'}, {'ForeName': 'Michiel A', 'Initials': 'MA', 'LastName': 'van Agtmael', 'Affiliation': 'Department of Internal Medicine, Amsterdam UMC, Amsterdam, the Netherlands.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Bresser', 'Affiliation': 'Department of Pulmonary Diseases, Onze Lieve Vrouwe Gasthuis, Amsterdam, the Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'Wiek H', 'Initials': 'WH', 'LastName': 'van Gilst', 'Affiliation': 'Department of Experimental Cardiology, UMCG, Groningen, the Netherlands.'}, {'ForeName': 'Anton', 'Initials': 'A', 'LastName': 'Vonk-Noordergraaf', 'Affiliation': 'Department of Pulmonary Diseases, Amsterdam UMC, Amsterdam, the Netherlands.'}, {'ForeName': 'Jan G P', 'Initials': 'JGP', 'LastName': 'Tijssen', 'Affiliation': 'Department of Cardiology, Amsterdam UMC, Amsterdam, the Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'van Royen', 'Affiliation': 'Department of Cardiology, Radboudumc, Nijmegen, the Netherlands.'}, {'ForeName': 'C Peter C', 'Initials': 'CPC', 'LastName': 'de Jager', 'Affiliation': ""Department of Intensive Care, Jeroen Bosch Hospital, 's-Hertogenbosch, the Netherlands.""}, {'ForeName': 'Michel M', 'Initials': 'MM', 'LastName': 'van den Heuvel', 'Affiliation': 'Department of Pulmonary diseases, Radboudumc, Nijmegen, the Netherlands.'}, {'ForeName': 'Hans G', 'Initials': 'HG', 'LastName': 'van der Hoeven', 'Affiliation': 'Department of Intensive Care, Radboudumc, Nijmegen, the Netherlands.'}, {'ForeName': 'Annelies', 'Initials': 'A', 'LastName': 'Verbon', 'Affiliation': 'Department of Medical Microbiology and Infectious Diseases, ErasmusMC, Rotterdam, the Netherlands.'}, {'ForeName': 'Yigal M', 'Initials': 'YM', 'LastName': 'Pinto', 'Affiliation': 'Department of Cardiology, Amsterdam UMC, Amsterdam, the Netherlands.'}, {'ForeName': 'Roland R J', 'Initials': 'RRJ', 'LastName': 'van Kimmenade', 'Affiliation': 'Department of Cardiology, Radboudumc, Nijmegen, the Netherlands.'}]",American heart journal,['10.1016/j.ahj.2020.05.010'] 1718,32512353,A Randomized Controlled Trial of Transcultural Validation of Group-Based Psychosocial Intervention for Patients with Bipolar Disorder.,"Adjunctive psychosocial interventions are part of the preferred method to treat bipolar disorder (BD). This study aimed to conduct a randomized control and protocol-guided trial, in order to evaluate the feasibility and effectiveness of adjunctive group-based treatments for Chinese outpatients with BD. A single-blind trial in which 68 outpatients with BD were randomly assigned to either treatment as usual (TAU) or to an experimental group with 12 additional weekly sessions and 3 monthly booster sessions. Participants were assessed at baseline for mood condition, suicidal ideation, medication adherence, and quality of life (QoL), with follow-up assessments every 3 months over a 1-year period. The overall retention rate of this study was 89.7%. The results showed significant differences between groups for the variables evaluated, which included achieving euthymia, decrease of depression symptoms, and improvement of QoL. No improvements in medication adherence, reduction in manic symptoms, or suicidal ideation was observed. The results of this study support the transcultural validity and efficacy of group-based psychosocial intervention as anadjunct to TAU among Chinese outpatients with BD to promote improvements during the course of the illness including achieving euthymia, reducing depressive symptoms, and improving QoL.",2020,"The results showed significant differences between groups for the variables evaluated, which included achieving euthymia, decrease of depression symptoms, and improvement of QoL. No improvements in medication adherence, reduction in manic symptoms, or suicidal ideation was observed.","['68 outpatients with BD', 'Patients with Bipolar Disorder', 'Chinese outpatients with BD']","['Adjunctive psychosocial interventions', 'psychosocial intervention', 'Group-Based Psychosocial Intervention']","['mood condition, suicidal ideation, medication adherence, and quality of life (QoL', 'medication adherence, reduction in manic symptoms, or suicidal ideation', 'feasibility and effectiveness', 'depression symptoms', 'transcultural validity and efficacy', 'depressive symptoms, and improving QoL', 'overall retention rate']","[{'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0005586', 'cui_str': 'Bipolar disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0424000', 'cui_str': 'Suicidal thoughts'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0338831', 'cui_str': 'Mania'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0042283', 'cui_str': 'Validity (Epidemiology)'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}]",68.0,0.0479467,"The results showed significant differences between groups for the variables evaluated, which included achieving euthymia, decrease of depression symptoms, and improvement of QoL. No improvements in medication adherence, reduction in manic symptoms, or suicidal ideation was observed.","[{'ForeName': 'Chen-Ju', 'Initials': 'CJ', 'LastName': 'Lin', 'Affiliation': 'Department of Psychiatry, MacKay Memorial Hospital, Taipei, Taiwan; Institute of Health and Welfare Policy, National Yang-Ming University.'}, {'ForeName': 'Yu-Hsin', 'Initials': 'YH', 'LastName': 'Huang', 'Affiliation': 'Department of Psychiatry, MacKay Memorial Hospital, Taipei, Taiwan; Department of Medicine, MacKay Medical College, Taipei, Taiwan.'}, {'ForeName': 'Kuo-Yang', 'Initials': 'KY', 'LastName': 'Huang', 'Affiliation': 'Department of Psychiatry, Taiwan Adventist Hospital, Taipei, Taiwan.'}, {'ForeName': 'Shu-I', 'Initials': 'SI', 'LastName': 'Wu', 'Affiliation': 'Department of Psychiatry, MacKay Memorial Hospital, Taipei, Taiwan; Department of Audiology and Speech Language Pathology, MacKay Medical College, Taipei, Taiwan.'}, {'ForeName': 'Yi-Hung', 'Initials': 'YH', 'LastName': 'Chang', 'Affiliation': 'Department of Psychiatry, MacKay Memorial Hospital, Taipei, Taiwan.'}, {'ForeName': 'Hsiao-Mei', 'Initials': 'HM', 'LastName': 'Yeh', 'Affiliation': 'Department of Psychiatry, MacKay Memorial Hospital, Taipei, Taiwan.'}, {'ForeName': 'Chih-Hung', 'Initials': 'CH', 'LastName': 'Chang', 'Affiliation': 'Department of Psychiatry, MacKay Memorial Hospital, Taipei, Taiwan; Department of Medicine, MacKay Medical College, Taipei, Taiwan.'}, {'ForeName': 'I-Chieh', 'Initials': 'IC', 'LastName': 'Lin', 'Affiliation': 'Department of Psychiatry, MacKay Memorial Hospital, Taipei, Taiwan.'}, {'ForeName': 'Hui-Chun', 'Initials': 'HC', 'LastName': 'Huang', 'Affiliation': 'Department of Medical Research, MacKay Memorial Hospital, Taipei, Taiwan; MacKay Junior College of Medicine, Nursing and Management, Taipei, Taiwan.'}, {'ForeName': 'Fang-Ju', 'Initials': 'FJ', 'LastName': 'Sun', 'Affiliation': 'Department of Medical Research, MacKay Memorial Hospital, Taipei, Taiwan; MacKay Junior College of Medicine, Nursing and Management, Taipei, Taiwan.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Berk', 'Affiliation': 'School of Medicine, Deakin University, Victoria, Australia.'}, {'ForeName': 'Shen-Ing', 'Initials': 'SI', 'LastName': 'Liu', 'Affiliation': 'Department of Psychiatry, MacKay Memorial Hospital, Taipei, Taiwan; Department of Medicine, MacKay Medical College, Taipei, Taiwan; Department of Medical Research, MacKay Memorial Hospital, Taipei, Taiwan. Electronic address: maryliuyip@gmail.com.'}]",Psychiatry research,['10.1016/j.psychres.2020.113139'] 1719,32513289,"The SARS-CoV-2 Ivermectin Navarra-ISGlobal Trial (SAINT) to Evaluate the Potential of Ivermectin to Reduce COVID-19 Transmission in low risk, non-severe COVID-19 patients in the first 48 hours after symptoms onset: A structured summary of a study protocol for a randomized control pilot trial.","OBJECTIVES The primary objective is to determine the efficacy of a single dose of ivermectin, administered to low risk, non-severe COVID-19 patients in the first 48 hours after symptom onset to reduce the proportion of patients with detectable SARS-CoV-2 RNA by Polymerase Chain Reaction (PCR) test from nasopharyngeal swab at day 7 post-treatment. The secondary objectives are: 1.To assess the efficacy of ivermectin to reduce the SARS-CoV-2 viral load in the nasopharyngeal swab at day 7 post treatment.2.To assess the efficacy of ivermectin to improve symptom progression in treated patients.3.To assess the proportion of seroconversions in treated patients at day 21.4.To assess the safety of ivermectin at the proposed dose.5.To determine the magnitude of immune response against SARS-CoV-2.6.To assess the early kinetics of immunity against SARS-CoV-2. TRIAL DESIGN SAINT is a single centre, double-blind, randomized, placebo-controlled, superiority trial with two parallel arms. Participants will be randomized to receive a single dose of 400 μg/kg ivermectin or placebo, and the number of patients in the treatment and placebo groups will be the same (1:1 ratio). PARTICIPANTS The population for the study will be patients with a positive nasopharyngeal swab PCR test for SARS-CoV-2, with non-severe COVID-19 disease, and no risk factors for progression to severity. Vulnerable populations such as pregnant women, minors (i.e.; under 18 years old), and seniors (i.e.; over 60 years old) will be excluded. Inclusion criteria 1. Patients diagnosed with COVID-19 in the emergency room of the Clínica Universidad de Navarra (CUN) with a positive SARS-CoV-2 PCR. 2. Residents of the Pamplona basin (""Cuenca de Pamplona""). 3. The patient must be between the ages of 18 and 60 years of age. 4. Negative pregnancy test for women of child bearing age*. 5. The patient or his/her representative, has given informed consent to participate in the study. 6. The patient should, in the PI's opinion, be able to comply with all the requirements of the clinical trial (including home follow up during isolation). Exclusion criteria 1. Known history of ivermectin allergy. 2. Hypersensitivity to any component of ivermectin. 3. COVID-19 pneumonia. Diagnosed by the attending physician.Identified in a chest X-ray. 4. Fever or cough present for more than 48 hours. 5. Positive IgG against SARS-CoV-2 by rapid diagnostic test. 6. Age under 18 or over 60 years. 7. The following co-morbidities (or any other disease that might interfere with the study in the eyes of the PI): Immunosuppression.Chronic Obstructive Pulmonary Disease.Diabetes.Hypertension.Obesity.Acute or chronic renal failure.History of coronary disease.History of cerebrovascular disease.Current neoplasm. 8. Recent travel history to countries that are endemic for Loa loa (Angola, Cameroon, Central African Republic, Chad, Democratic Republic of Congo, Ethiopia, Equatorial, Guinea, Gabon, Republic of Congo, Nigeria and Sudan). 9. Current use of CYP 3A4 or P-gp inhibitor drugs such as quinidine, amiodarone, diltiazem, spironolactone, verapamil, clarithromycin, erythromycin, itraconazole, ketoconazole, cyclosporine, tacrolimus, indinavir, ritonavir or cobicistat. Use of critical CYP3A4 substrate drugs such as warfarin. *Women of child bearing age may participate if they use a safe contraceptive method for the entire period of the study and at least one month afterwards. A woman is considered to not have childbearing capacity if she is post-menopausal (minimum of 2 years without menstruation) or has undergone surgical sterilization (at least one month before the study). The trial is currently planned at a single center, Clínica Universidad de Navarra, in Navarra (Spain), and the immunology samples will be analyzed at the Barcelona Institute for Global Health (ISGlobal), in Barcelona (Spain). Participants will be recruited by the investigators at the emergency room and/or COVID-19 area of the CUN. They will remain in the trial for a period of 28 days at their homes since they will be patients with mild disease. In the interest of public health and to contain transmission of infection, follow-up visits will be conducted in the participant's home by a clinical trial team comprising nursing and medical members. Home visits will assess clinical and laboratory parameters of the patients. INTERVENTION AND COMPARATOR Ivermectin will be administered to the treatment group at a 400μg/Kg dose (included in the EU approved label of Stromectol and Scabioral). The control group will receive placebo. There is no current data on the efficacy of ivermectin against the virus in vivo, therefore the use of placebo in the control group is ethically justified. MAIN OUTCOMES Primary Proportion of patients with a positive SARS-CoV-2 PCR from a nasopharyngeal swab at day 7 post-treatment. Secondary 1.Mean viral load as determined by PCR cycle threshold (Ct) at baseline and on days 4, 7, 14, and 21.2.Proportion of patients with fever and cough at days 4, 7, 14, and 21 as well as proportion of patients progressing to severe disease or death during the trial.3.Proportion of patients with seroconversion at day 21.4.Proportion of drug-related adverse events during the trial.5.Median levels of IgG, IgM, IgA measured by Luminex, frequencies of innate and SARS-CoV-2-specific T cells assessed by flow cytometry, median levels of inflammatory and activation markers measured by Luminex and transcriptomics.6.Median kinetics of IgG, IgM, IgA levels during the trial, until day 28. RANDOMISATION Eligible patients will be allocated in a 1:1 ratio using a randomization list generated by the trial statistician using blocks of four to ensure balance between the groups. A study identification code with the format ""SAINT-##"" (##: from 01 to 24) will be generated using a sequence of random numbers so that the randomization number does not match the subject identifier. The sequence and code used will be kept in an encrypted file accessible only to the trial statistician. A physical copy will be kept in a locked cabinet at the CUN, accessible only to the person administering the drug who will not enrol or attend to patient care. A separate set of 24 envelopes for emergency unblinding will be kept in the study file. BLINDING (MASKING) The clinical trial team and the patients will be blinded. The placebo will not be visibly identical, but it will be administered by staff not involved in the clinical care or participant follow up. NUMBERS TO BE RANDOMISED (SAMPLE SIZE) The sample size is 24 patients: 12 participants will be randomised to the treatment group and 12 participants to the control group. TRIAL STATUS Current protocol version: 1.0 dated 16 of April 2020. Recruitment is envisioned to begin by May 14th and end by June 14th. TRIAL REGISTRATION EudraCT number: 2020-001474-29, registered April 1 st . Clinicaltrials.gov: submitted, pending number FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.",2020,"Secondary 1.Mean viral load as determined by PCR cycle threshold (Ct) at baseline and on days 4, 7, 14, and 21.2.Proportion of patients with fever and cough at days 4, 7, 14, and 21 as well as proportion of patients progressing to severe disease or death during the trial.3.Proportion of patients with seroconversion at day 21.4.Proportion of drug-related adverse events during the trial.5.Median levels of IgG, IgM, IgA measured by Luminex, frequencies of innate and SARS-CoV-2-specific T cells assessed by flow cytometry, median levels of inflammatory and activation markers measured by Luminex and transcriptomics.6.Median kinetics of IgG, IgM, IgA levels during the trial, until day 28","['2020-001474-29, registered April 1 st ', 'Acute or chronic renal failure', 'women of child bearing age*. 5', 'The population for the study will be patients with a positive nasopharyngeal swab PCR test for SARS-CoV-2, with non-severe COVID-19 disease, and no risk factors for progression to severity', 'pregnant women, minors (i.e.; under 18 years old), and seniors (i.e.; over 60 years old', 'low risk, non-severe COVID-19 patients in the first 48 hours after symptoms onset', '24 patients: 12 participants', 'patients with mild disease', 'Chronic Obstructive Pulmonary Disease', 'Participants will be recruited by the investigators at the emergency room and/or COVID-19 area of the CUN', 'Patients diagnosed with COVID-19 in the emergency room of the Clínica Universidad de Navarra (CUN) with a positive SARS-CoV-2 PCR', 'Residents of the Pamplona basin (""Cuenca de Pamplona', 'Age under 18 or over 60 years']","['ivermectin', 'Ivermectin', 'quinidine, amiodarone, diltiazem, spironolactone, verapamil, clarithromycin, erythromycin, itraconazole, ketoconazole, cyclosporine, tacrolimus, indinavir, ritonavir or cobicistat', 'ivermectin or placebo', 'placebo']","['fever and cough', 'SARS-CoV-2 viral load', 'positive SARS-CoV-2 PCR', 'PCR cycle threshold (Ct', 'symptom progression', 'IgG, IgM, IgA measured by Luminex, frequencies of innate and SARS-CoV-2-specific T cells assessed by flow cytometry, median levels of inflammatory and activation markers measured by Luminex and transcriptomics.6.Median kinetics of IgG, IgM, IgA levels', 'Negative pregnancy test', 'Fever or cough', 'severe disease or death']","[{'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0022661', 'cui_str': 'Chronic renal failure'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0444192', 'cui_str': 'Nasopharyngeal swab'}, {'cui': 'C0032520', 'cui_str': 'Polymerase chain reaction'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0026193', 'cui_str': 'Minor'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0439586', 'cui_str': '48 hours'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0179226', 'cui_str': 'Basin'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0022322', 'cui_str': 'Ivermectin'}, {'cui': 'C0034414', 'cui_str': 'Quinidine'}, {'cui': 'C0002598', 'cui_str': 'Amiodarone'}, {'cui': 'C0012373', 'cui_str': 'Diltiazem'}, {'cui': 'C0037982', 'cui_str': 'Spironolactone'}, {'cui': 'C0042523', 'cui_str': 'Verapamil'}, {'cui': 'C0055856', 'cui_str': 'Clarithromycin'}, {'cui': 'C0014806', 'cui_str': 'Erythromycin'}, {'cui': 'C0064113', 'cui_str': 'Itraconazole'}, {'cui': 'C0022625', 'cui_str': 'Ketoconazole'}, {'cui': 'C0010592', 'cui_str': 'Cyclosporine'}, {'cui': 'C0085149', 'cui_str': 'Tacrolimus'}, {'cui': 'C0376637', 'cui_str': 'Indinavir'}, {'cui': 'C0292818', 'cui_str': 'Ritonavir'}, {'cui': 'C3177235', 'cui_str': 'cobicistat'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0032520', 'cui_str': 'Polymerase chain reaction'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0020861', 'cui_str': 'Immunoglobulin M'}, {'cui': 'C0020835', 'cui_str': 'Immunoglobulin A'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}, {'cui': 'C0016263', 'cui_str': 'Flow cytometry'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0022702', 'cui_str': 'Kinetics'}, {'cui': 'C0427780', 'cui_str': 'Pregnancy test negative'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",12.0,0.246002,"Secondary 1.Mean viral load as determined by PCR cycle threshold (Ct) at baseline and on days 4, 7, 14, and 21.2.Proportion of patients with fever and cough at days 4, 7, 14, and 21 as well as proportion of patients progressing to severe disease or death during the trial.3.Proportion of patients with seroconversion at day 21.4.Proportion of drug-related adverse events during the trial.5.Median levels of IgG, IgM, IgA measured by Luminex, frequencies of innate and SARS-CoV-2-specific T cells assessed by flow cytometry, median levels of inflammatory and activation markers measured by Luminex and transcriptomics.6.Median kinetics of IgG, IgM, IgA levels during the trial, until day 28","[{'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Chaccour', 'Affiliation': 'Instituto de Salud Global de Barcelona, Barcelona, Spain. carlos.chaccour@isglobal.org.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Ruiz-Castillo', 'Affiliation': 'Instituto de Salud Global de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Mary-Ann', 'Initials': 'MA', 'LastName': 'Richardson', 'Affiliation': 'Instituto de Salud Global de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Gemma', 'Initials': 'G', 'LastName': 'Moncunill', 'Affiliation': 'Instituto de Salud Global de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Aina', 'Initials': 'A', 'LastName': 'Casellas', 'Affiliation': 'Instituto de Salud Global de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Carmona-Torre', 'Affiliation': 'Instituto de Salud Global de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Giráldez', 'Affiliation': 'Instituto de Salud Global de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Juana Schwartz', 'Initials': 'JS', 'LastName': 'Mota', 'Affiliation': 'Instituto de Salud Global de Barcelona, Barcelona, Spain.'}, {'ForeName': 'José Ramón', 'Initials': 'JR', 'LastName': 'Yuste', 'Affiliation': 'Instituto de Salud Global de Barcelona, Barcelona, Spain.'}, {'ForeName': 'José Ramón', 'Initials': 'JR', 'LastName': 'Azanza', 'Affiliation': 'Instituto de Salud Global de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Fernández', 'Affiliation': 'Instituto de Salud Global de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Reina', 'Affiliation': 'Instituto de Salud Global de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Carlota', 'Initials': 'C', 'LastName': 'Dobaño', 'Affiliation': 'Instituto de Salud Global de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Joe', 'Initials': 'J', 'LastName': 'Brew', 'Affiliation': 'Instituto de Salud Global de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Belen', 'Initials': 'B', 'LastName': 'Sadaba', 'Affiliation': 'Instituto de Salud Global de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Hammann', 'Affiliation': 'Instituto de Salud Global de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Regina', 'Initials': 'R', 'LastName': 'Rabinovich', 'Affiliation': 'Instituto de Salud Global de Barcelona, Barcelona, Spain.'}]",Trials,['10.1186/s13063-020-04421-z'] 1720,32514590,Time to intra-arrest therapeutic hypothermia in out-of-hospital cardiac arrest patients and its association with neurologic outcome: a propensity matched sub-analysis of the PRINCESS trial.,"PURPOSE To study the association between early initiation of intra-arrest therapeutic hypothermia and neurologic outcome in out-of-hospital cardiac arrest. METHODS A prespecified sub-analysis of the PRINCESS trial (NCT01400373) that randomized 677 bystander-witnessed cardiac arrests to transnasal evaporative intra-arrest cooling initiated by emergency medical services or cooling started after hospital arrival. Early cooling (intervention) was defined as intra-arrest cooling initiated < 20 min from collapse (i.e., ≤ median time to cooling in PRINCESS). Propensity score matching established comparable control patients. Primary outcome was favorable neurologic outcome, Cerebral Performance Category (CPC) 1-2 at 90 days. Complete recovery (CPC 1) was among secondary outcomes. RESULTS In total, 300 patients were analyzed and the proportion with CPC 1-2 at 90 days was 35/150 (23.3%) in the intervention group versus 24/150 (16%) in the control group, odds ratio (OR) 1.92, 95% confidence interval (CI) 0.95-3.85, p = .07. In patients with shockable rhythm, CPC 1-2 was 29/57 (50.9%) versus 17/57 (29.8%), OR 3.25, 95%, CI 1.06-9.97, p = .04. The proportion with CPC 1 at 90 days was 31/150 (20.7%) in the intervention group and 17/150 (11.3%) in controls, OR 2.27, 95% CI 1.12-4.62, p = .02. In patients with shockable rhythms, the proportion with CPC 1 was 27/57 (47.4%) versus 12/57 (21.1%), OR 5.33, 95% CI 1.55-18.3, p = .008. CONCLUSIONS In the whole study population, intra-arrest cooling initiated < 20 min from collapse compared to cooling initiated at hospital was not associated with improved favorable neurologic outcome. In the subgroup with shockable rhythms, early cooling was associated with improved favorable outcome and complete recovery.",2020,"The proportion with CPC 1 at 90 days was 31/150 (20.7%) in the intervention group and 17/150 (11.3%) in controls, OR 2.27, 95% CI 1.12-4.62, p = .02.",[],"['677 bystander-witnessed cardiac arrests to transnasal evaporative intra-arrest cooling initiated by emergency medical services or cooling started after hospital arrival', 'Time to intra-arrest therapeutic hypothermia']","['favorable outcome and complete recovery', 'favorable neurologic outcome, Cerebral Performance Category (CPC', 'favorable neurologic outcome']",[],"[{'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}, {'cui': 'C0521131', 'cui_str': 'Transnasal approach'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0013961', 'cui_str': 'Emergency medical services'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0020674', 'cui_str': 'Induction of hypothermia'}]","[{'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}]",677.0,0.16917,"The proportion with CPC 1 at 90 days was 31/150 (20.7%) in the intervention group and 17/150 (11.3%) in controls, OR 2.27, 95% CI 1.12-4.62, p = .02.","[{'ForeName': 'Akil', 'Initials': 'A', 'LastName': 'Awad', 'Affiliation': 'Department of Medicine, Center for Resuscitation Science, Karolinska Institute, Solna, Sweden.'}, {'ForeName': 'Fabio Silvio', 'Initials': 'FS', 'LastName': 'Taccone', 'Affiliation': 'Department of Intensive Care, Erasme Hospital, Université Libre de Bruxelles (ULB), Brussels, Belgium.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Jonsson', 'Affiliation': 'Department of Medicine, Center for Resuscitation Science, Karolinska Institute, Solna, Sweden.'}, {'ForeName': 'Sune', 'Initials': 'S', 'LastName': 'Forsberg', 'Affiliation': 'Department of Medicine, Center for Resuscitation Science, Karolinska Institute, Solna, Sweden.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Hollenberg', 'Affiliation': 'Department of Medicine, Center for Resuscitation Science, Karolinska Institute, Solna, Sweden.'}, {'ForeName': 'Anatolij', 'Initials': 'A', 'LastName': 'Truhlar', 'Affiliation': 'Emergency Medical Services of the Hradec Kralove Region, Hradec Králové, Czech Republic.'}, {'ForeName': 'Mattias', 'Initials': 'M', 'LastName': 'Ringh', 'Affiliation': 'Department of Medicine, Center for Resuscitation Science, Karolinska Institute, Solna, Sweden.'}, {'ForeName': 'Benjamin S', 'Initials': 'BS', 'LastName': 'Abella', 'Affiliation': 'The Center for Resuscitation Science and Department of Emergency Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Lance B', 'Initials': 'LB', 'LastName': 'Becker', 'Affiliation': 'Department of Emergency Medicine, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Manhasset, NY, 11030, USA.'}, {'ForeName': 'Jean-Louis', 'Initials': 'JL', 'LastName': 'Vincent', 'Affiliation': 'Department of Intensive Care, Erasme Hospital, Université Libre de Bruxelles (ULB), Brussels, Belgium.'}, {'ForeName': 'Leif', 'Initials': 'L', 'LastName': 'Svensson', 'Affiliation': 'Department of Medicine, Center for Resuscitation Science, Karolinska Institute, Solna, Sweden.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Nordberg', 'Affiliation': 'Department of Medicine, Center for Resuscitation Science, Karolinska Institute, Solna, Sweden. per.nordberg@sll.se.'}]",Intensive care medicine,['10.1007/s00134-020-06024-3'] 1721,32517498,"Comparison of efficacy of a supervised versus non-supervised physical therapy exercise program on the pain, functionality and quality of life of patients with non-specific chronic low-back pain: a randomized controlled trial.","OBJECTIVE To compare the effectiveness of supervised physical therapy program versus non-supervised on pain, functionality, fear of movement and quality of life in patients with non-specific chronic low back pain. DESIGN A randomized double-blind clinical trial. SETTING Clinical outpatient unit; home. SUBJECTS A total of 64 participants with non-specific chronic low back pain were randomized into either supervised exercise group ( n  = 32) or non-supervised home exercise group ( n  = 32). INTERVENTIONS The supervised group was treated with therapy exercises (strengthen lumbopelvic musculature), while the non-supervised received an informative session of the exercises, which were performed un-supervised at home. Both groups received three weekly sessions for eight weeks. MAIN MEASURES Pain, disability, fear of movement, quality of life, trunk muscle endurance and trunk anteflexion motion were assessed at baseline, two, and six months of follow-up. RESULTS Although analysis of variance (ANOVA) test showed statistically significant differences between groups for pain ( P  = 0.028; supervised: 2.5 ± 2.1; non-supervised: 3.5 ± 1.5) and disability for Roland-Morris Disability Questionnaire ( P  = 0.004; supervised: 3.1 ± 2.2; non-supervised: 5.1 ± 3.0) and for Oswestry Disability Index ( P  = 0.034; supervised: 14.5 ± 7.1; non-supervised: 19.2 ± 10.0) at 8 weeks immediately posttreatment, there were no differences between the groups in patient-rated pain, functionality, fear of movement and quality of life at six months of follow-up. CONCLUSION Patients with chronic low back pain who received supervised exercise showed more improvement in both the short and long term in all patient-rated outcomes over the non-supervised group, but the differences were small and not clinically significant.",2020,"Although analysis of variance (ANOVA) test showed statistically significant differences between groups for pain ( P  = 0.028; supervised: 2.5 ± 2.1; non-supervised: 3.5 ± 1.5) and disability for Roland-Morris Disability Questionnaire ( P  = 0.004; supervised: 3.1 ± 2.2; non-supervised: 5.1 ± 3.0) and for Oswestry Disability Index ( P  = 0.034; supervised: 14.5 ± 7.1; non-supervised: 19.2 ± 10.0) at 8 weeks immediately posttreatment, there were no differences between the groups in patient-rated pain, functionality, fear of movement and quality of life at six months of follow-up. ","['patients with non-specific chronic low back pain', '64 participants with non-specific chronic low back pain', 'patients with non-specific chronic low-back pain']","['supervised exercise', 'supervised exercise group ( n \u2009=\u200932) or non-supervised home exercise group', 'supervised versus non-supervised physical therapy exercise program', 'supervised physical therapy program versus non-supervised', 'therapy exercises (strengthen lumbopelvic musculature), while the non-supervised received an informative session of the exercises, which were performed un-supervised at home']","['pain, functionality and quality of life', 'disability for Roland-Morris Disability Questionnaire', 'Pain, disability, fear of movement, quality of life, trunk muscle endurance and trunk anteflexion motion', 'pain', 'patient-rated pain, functionality, fear of movement and quality of life', 'Oswestry Disability Index', 'pain, functionality, fear of movement and quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205370', 'cui_str': 'Non-specific'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1276393', 'cui_str': 'Group exercise'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0452240', 'cui_str': 'Exercises'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0581755', 'cui_str': 'Skeletal muscle structure of trunk'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0460005', 'cui_str': 'Trunk structure'}, {'cui': 'C0333043', 'cui_str': 'Anterior displacement'}, {'cui': 'C0026597', 'cui_str': 'Motion'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index'}]",64.0,0.0799912,"Although analysis of variance (ANOVA) test showed statistically significant differences between groups for pain ( P  = 0.028; supervised: 2.5 ± 2.1; non-supervised: 3.5 ± 1.5) and disability for Roland-Morris Disability Questionnaire ( P  = 0.004; supervised: 3.1 ± 2.2; non-supervised: 5.1 ± 3.0) and for Oswestry Disability Index ( P  = 0.034; supervised: 14.5 ± 7.1; non-supervised: 19.2 ± 10.0) at 8 weeks immediately posttreatment, there were no differences between the groups in patient-rated pain, functionality, fear of movement and quality of life at six months of follow-up. ","[{'ForeName': 'Guillermo A', 'Initials': 'GA', 'LastName': 'Matarán-Peñarrocha', 'Affiliation': 'Andalusian Health Service, Family Medicine and Primary Care, Distrito Sanitario Málaga, Granada, Spain.'}, {'ForeName': 'Inmaculada Carmen', 'Initials': 'IC', 'LastName': 'Lara Palomo', 'Affiliation': 'Department of Nursing, Physical Therapy and Medicine, University of Almeria, Almeria, Spain.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Antequera Soler', 'Affiliation': 'Department of Nursing, Physical Therapy and Medicine, University of Almeria, Almeria, Spain.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Gil-Martínez', 'Affiliation': 'Department of Nursing, Physical Therapy and Medicine, University of Almeria, Almeria, Spain.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Fernández-Sánchez', 'Affiliation': 'Department of Nursing, Physical Therapy and Medicine, University of Almeria, Almeria, Spain.'}, {'ForeName': 'María Encarnación', 'Initials': 'ME', 'LastName': 'Aguilar-Ferrándiz', 'Affiliation': 'Department of Physical Therapy, University of Granada, Granada, Spain.'}, {'ForeName': 'Adelaida María', 'Initials': 'AM', 'LastName': 'Castro-Sánchez', 'Affiliation': 'Department of Nursing, Physical Therapy and Medicine, University of Almeria, Almeria, Spain.'}]",Clinical rehabilitation,['10.1177/0269215520927076'] 1722,32519676,Spelling Errors and Shouting Capitalization Lead to Additive Penalties to Trustworthiness of Online Health Information: Randomized Experiment With Laypersons.,"BACKGROUND The written format and literacy competence of screen-based texts can interfere with the perceived trustworthiness of health information in online forums, independent of the semantic content. Unlike in professional content, the format in unmoderated forums can regularly hint at incivility, perceived as deliberate rudeness or casual disregard toward the reader, for example, through spelling errors and unnecessary emphatic capitalization of whole words (online shouting). OBJECTIVE This study aimed to quantify the comparative effects of spelling errors and inappropriate capitalization on ratings of trustworthiness independently of lay insight and to determine whether these changes act synergistically or additively on the ratings. METHODS In web-based experiments, 301 UK-recruited participants rated 36 randomized short stimulus excerpts (in the format of information from an unmoderated health forum about multiple sclerosis) for trustworthiness using a semantic differential slider. A total of 9 control excerpts were compared with matching error-containing excerpts. Each matching error-containing excerpt included 5 instances of misspelling, or 5 instances of inappropriate capitalization (shouting), or a combination of 5 misspelling plus 5 inappropriate capitalization errors. Data were analyzed in a linear mixed effects model. RESULTS The mean trustworthiness ratings of the control excerpts ranged from 32.59 to 62.31 (rating scale 0-100). Compared with the control excerpts, excerpts containing only misspellings were rated as being 8.86 points less trustworthy, those containing inappropriate capitalization were rated as 6.41 points less trustworthy, and those containing the combination of misspelling and capitalization were rated as 14.33 points less trustworthy (P<.001 for all). Misspelling and inappropriate capitalization show an additive effect. CONCLUSIONS Distinct indicators of incivility independently and additively penalize the perceived trustworthiness of online text independently of lay insight, eliciting a medium effect size.",2020,The mean trustworthiness ratings of the control excerpts ranged from 32.59 to 62.31 (rating scale 0-100).,['301 UK-recruited participants rated 36'],"['inappropriate capitalization (shouting), or a combination of 5 misspelling plus 5 inappropriate capitalization errors', 'spelling errors and inappropriate capitalization', 'randomized short stimulus excerpts (in the format of information from an unmoderated health forum about multiple sclerosis) for trustworthiness using a semantic differential slider']",['mean trustworthiness ratings'],"[{'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}]","[{'cui': 'C3542467', 'cui_str': 'Inappropriate'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C1301627', 'cui_str': 'Format'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0036611', 'cui_str': 'Differential, Semantic'}, {'cui': 'C1005353', 'cui_str': 'Trachemys'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}]",,0.0768117,The mean trustworthiness ratings of the control excerpts ranged from 32.59 to 62.31 (rating scale 0-100).,"[{'ForeName': 'Harry J', 'Initials': 'HJ', 'LastName': 'Witchel', 'Affiliation': 'Department of Neuroscience, Brighton and Sussex Medical School, Brighton, United Kingdom.'}, {'ForeName': 'Georgina A', 'Initials': 'GA', 'LastName': 'Thompson', 'Affiliation': 'Department of Neuroscience, Brighton and Sussex Medical School, Brighton, United Kingdom.'}, {'ForeName': 'Christopher I', 'Initials': 'CI', 'LastName': 'Jones', 'Affiliation': 'Department of Primary Care and Public Health, Brighton and Sussex Medical School, Brighton, United Kingdom.'}, {'ForeName': 'Carina E I', 'Initials': 'CEI', 'LastName': 'Westling', 'Affiliation': 'Faculty of Media and Communication, Bournemouth University, Bournemouth, United Kingdom.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Romero', 'Affiliation': 'Dalton Maag Ltd, London, United Kingdom.'}, {'ForeName': 'Alessia', 'Initials': 'A', 'LastName': 'Nicotra', 'Affiliation': 'Dalton Maag Ltd, London, United Kingdom.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Maag', 'Affiliation': 'Dalton Maag Ltd, London, United Kingdom.'}, {'ForeName': 'Hugo D', 'Initials': 'HD', 'LastName': 'Critchley', 'Affiliation': 'Department of Neuroscience, Brighton and Sussex Medical School, Brighton, United Kingdom.'}]",Journal of medical Internet research,['10.2196/15171'] 1723,32520909,Impact of Routine Point-of-Care Versus Laboratory Testing for Early Infant Diagnosis of HIV: Results From a Multicountry Stepped-Wedge Cluster-Randomized Controlled Trial.,"BACKGROUND Although the World Health Organization recommends HIV-exposed infants receive a 6-week diagnostic test, few receive results by 12 weeks. Point-of-care (POC) early infant diagnosis (EID) may improve timely diagnosis and treatment. This study assesses the impact of routine POC versus laboratory-based EID on return of results by 12 weeks of age. METHODS This was a cluster-randomized stepped-wedge trial in Kenya and Zimbabwe. In each country, 18 health facilities were randomly selected for inclusion and randomized to timing of POC implementation. FINDINGS Nine thousand five hundred thirty-nine infants received tests: 5115 laboratory-based and 4424 POC. In Kenya and Zimbabwe, respectively, caregivers were 1.29 times [95% confidence interval (CI): 1.27 to 1.30, P < 0.001] and 4.56 times (95% CI: 4.50 to 4.60, P < 0.001) more likely to receive EID results by 12 weeks of age with POC versus laboratory-based EID. POC significantly reduced the time between sample collection and return of results to caregiver by an average of 23.03 days (95% CI: 4.85 to 21.21, P < 0.001) in Kenya and 62.37 days (95% CI: 58.94 to 65.80, P < 0.001) in Zimbabwe. For HIV-infected infants, POC significantly increased the percentage initiated on treatment, from 43.2% to 79.6% in Zimbabwe, and resulted in a nonsignificant increase in Kenya from 91.7% to 100%. The introduction of POC EID also significantly reduced the time to antiretroviral therapy initiation by an average of 17.01 days (95% CI: 9.38 to 24.64, P < 0.001) in Kenya and 56.00 days (95% CI: 25.13 to 153.76, P < 0.001) in Zimbabwe. CONCLUSIONS POC confers significant advantage on the proportion of caregivers receiving timely EID results, and improves time to results receipt and treatment initiation for infected infants. Where laboratory-based EID systems are unable to deliver results to caregivers rapidly, POC should be implemented as part of an integrated testing system.",2020,"The introduction of POC EID also significantly reduced the time to antiretroviral therapy initiation by an average of 17.01 days (95% CI: 9.38 to 24.64, P < 0.001) in Kenya and 56.00 days (95% CI: 25.13 to 153.76, P < 0.001) in Zimbabwe. ","['18 health facilities', 'Nine thousand five hundred thirty-nine infants received tests: 5115 laboratory-based and 4424 POC', 'Early Infant Diagnosis of HIV']","['routine POC versus laboratory-based EID', 'Routine Point-of-Care Versus Laboratory Testing']",['time to antiretroviral therapy initiation'],"[{'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C4708915', 'cui_str': '9000'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C3816447', 'cui_str': '39'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0282664', 'cui_str': 'Point-of-Care'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}]","[{'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0282664', 'cui_str': 'Point-of-Care'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0022885', 'cui_str': 'Laboratory procedure'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}]",9539.0,0.210826,"The introduction of POC EID also significantly reduced the time to antiretroviral therapy initiation by an average of 17.01 days (95% CI: 9.38 to 24.64, P < 0.001) in Kenya and 56.00 days (95% CI: 25.13 to 153.76, P < 0.001) in Zimbabwe. ","[{'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Sacks', 'Affiliation': 'Department of Global Health, George Washington School of Public Health, Washington, DC.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Cohn', 'Affiliation': 'Elizabeth Glaser Pediatric AIDS Foundation, Geneva, Switzerland.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Ochuka', 'Affiliation': 'Elizabeth Glaser Pediatric AIDS Foundation, Nairobi, Kenya.'}, {'ForeName': 'Haurovi', 'Initials': 'H', 'LastName': 'Mafaune', 'Affiliation': 'Elizabeth Glaser Pediatric AIDS Foundation, Harare, Zimbabwe.'}, {'ForeName': 'Addmore', 'Initials': 'A', 'LastName': 'Chadambuka', 'Affiliation': 'Elizabeth Glaser Pediatric AIDS Foundation, Harare, Zimbabwe.'}, {'ForeName': 'Collins', 'Initials': 'C', 'LastName': 'Odhiambo', 'Affiliation': 'Elizabeth Glaser Pediatric AIDS Foundation, Nairobi, Kenya.'}, {'ForeName': 'Rose', 'Initials': 'R', 'LastName': 'Masaba', 'Affiliation': 'Elizabeth Glaser Pediatric AIDS Foundation, Nairobi, Kenya.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Githuka', 'Affiliation': 'Ministry of Health, Nairobi, Kenya.'}, {'ForeName': 'Agnes', 'Initials': 'A', 'LastName': 'Mahomva', 'Affiliation': 'Ministry of Health and Child Care, Harare, Zimbabwe.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Mushavi', 'Affiliation': 'Ministry of Health and Child Care, Harare, Zimbabwe.'}, {'ForeName': 'Jean-Francois', 'Initials': 'JF', 'LastName': 'Lemaire', 'Affiliation': 'Elizabeth Glaser Pediatric AIDS Foundation, Geneva, Switzerland.'}, {'ForeName': 'Flavia', 'Initials': 'F', 'LastName': 'Bianchi', 'Affiliation': 'Elizabeth Glaser Pediatric AIDS Foundation, Washington, DC.'}, {'ForeName': 'Rhoderick', 'Initials': 'R', 'LastName': 'Machekano', 'Affiliation': 'Elizabeth Glaser Pediatric AIDS Foundation, Washington, DC.'}]",Journal of acquired immune deficiency syndromes (1999),['10.1097/QAI.0000000000002383'] 1724,32521782,"Effect of Morning vs. Evening Turmeric Consumption on Urine Oxidative Stress Biomarkers in Obese, Middle-Aged Adults: A Feasibility Study.","The circadian rhythm of biological systems is an important consideration in developing health interventions. The immune and oxidative defense systems exhibit circadian periodicity, with an anticipatory increase in activity coincident with the onset of the active period. Spice consumption is associated with enhanced oxidative defense. The objective of this study was to test the feasibility of a protocol, comparing the effects of morning vs. evening consumption of turmeric on urine markers of oxidative stress in obese, middle-aged adults. Using a within-sample design, participants received each of four clock time x treatment administrations, each separated by one week: morning turmeric; evening turmeric; morning control; evening control. Participants prepared for each lab visit by consuming a low-antioxidant diet for two days and fasting for 12 h. Urine was collected in the lab at baseline and one-hour post-meal and at home for the following five hours. The results showed that the processes were successful in executing the protocol and collecting the measurements and that participants understood and adhered to the instructions. The findings also revealed that the spice treatment did not elicit the expected antioxidant effect and that the six-hour post-treatment urine collection period did not detect differences in urine endpoints across treatments. This feasibility study revealed that modifications to the spice treatment and urine sampling timeline are needed before implementing a larger study.",2020,The results showed that the processes were successful in executing the protocol and collecting the measurements and that participants understood and adhered to the instructions.,"['obese, middle-aged adults', 'Obese, Middle-Aged Adults']","['morning vs. evening consumption of turmeric', 'Morning vs. Evening Turmeric Consumption']","['Urine Oxidative Stress Biomarkers', 'antioxidant effect']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0332170', 'cui_str': 'Morning'}, {'cui': 'C0587117', 'cui_str': 'Evening'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0041356', 'cui_str': 'Turmeric'}]","[{'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C3179302', 'cui_str': 'Antioxidant Effects'}]",,0.0773991,The results showed that the processes were successful in executing the protocol and collecting the measurements and that participants understood and adhered to the instructions.,"[{'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Blanton', 'Affiliation': 'Department of Nutrition and Dietetics, Idaho State University, Pocatello, ID 83209, USA.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Gordon', 'Affiliation': 'Department of Nutrition and Dietetics, Idaho State University, Pocatello, ID 83209, USA.'}]",International journal of environmental research and public health,['10.3390/ijerph17114088'] 1725,32522503,"Sensory aspects of acceptability of bitter-flavoured 7.5 mm film-coated tablets in adults, preschool and school children.","There is great interest in demonstrating acceptability of solid oral formulations in paediatric populations. This study investigated the acceptability of small, 7.5 mm, bitter-flavoured, coated tablets in healthy children and adults. A randomised, double-blind acceptability test was performed involving 101 children (4-12 years) and 52 adults (18-75 years). Acceptability was measured by participants as sensory assessment of taste, mouthfeel and hedonic perception, and by researcher observations of ability to swallow the tablet and negative facial expressions. Additionally, the taste-masking effect of film coatings was assessed based on the intensity of bitterness perception. At least one tablet was voluntarily swallowed by 35.7% of 4-6-year olds, 74% of 7-12-year olds and 98% of adults. The bitterness of the tablet did not affect participants' ability to swallow it. The sensory properties determined whether the tablet was acceptable. The following factors: low bitterness, high smoothness, high slipperiness and pleasant aftertaste had a positive impact on overall palatability in both populations. The paediatric scores during sensory evaluation of tablets differed from adults, showing lower acceptability. This study demonstrates the multifactorial nature of palatability of tablets and highlights that adults' palatability evaluation cannot be directly translated to a paediatric population.",2020,"The paediatric scores during sensory evaluation of tablets differed from adults, showing lower acceptability.","['healthy children and adults', 'adults, preschool and school children', '101 children (4-12 years) and 52 adults (18-75 years']",['bitter-flavoured 7.5 mm film-coated tablets'],"['overall palatability', 'Acceptability', 'sensory assessment of taste, mouthfeel and hedonic perception, and by researcher observations of ability to swallow the tablet and negative facial expressions']","[{'cui': 'C0686744', 'cui_str': 'Well child'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0260267', 'cui_str': 'School child'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0235290', 'cui_str': 'Taste bitter'}, {'cui': 'C0682897', 'cui_str': 'Flavor Enhancers'}, {'cui': 'C4517859', 'cui_str': '7.5'}, {'cui': 'C1273643', 'cui_str': 'Film-coated tablet'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0039336', 'cui_str': 'Finding of sense of taste'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0566355', 'cui_str': 'Ability to swallow'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}]",101.0,0.21376,"The paediatric scores during sensory evaluation of tablets differed from adults, showing lower acceptability.","[{'ForeName': 'Justyna Katarzyna', 'Initials': 'JK', 'LastName': 'Hofmanová', 'Affiliation': 'School of Pharmacy, University of Birmingham, Edgbaston, Birmingham B15 2TT, United Kingdom.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Mason', 'Affiliation': 'School of Pharmacy, University of Birmingham, Edgbaston, Birmingham B15 2TT, United Kingdom.'}, {'ForeName': 'Hannah Katharine', 'Initials': 'HK', 'LastName': 'Batchelor', 'Affiliation': 'School of Pharmacy, University of Birmingham, Edgbaston, Birmingham B15 2TT, United Kingdom; Strathclyde Institute of Pharmacy and Biomedical Sciences, University of Strathclyde, 161 Cathedral Street, Glasgow G4 0RE, United Kingdom. Electronic address: h.k.batchelor@bham.ac.uk.'}]",International journal of pharmaceutics,['10.1016/j.ijpharm.2020.119511'] 1726,31196847,Long-term safety of single-agent ibrutinib in patients with chronic lymphocytic leukemia in 3 pivotal studies.,"Ibrutinib, a first-in-class once-daily oral Bruton tyrosine kinase inhibitor indicated for chronic lymphocytic leukemia (CLL), is continued until progressive disease or unacceptable toxicity. We conducted an integrated safety analysis of single-agent ibrutinib from randomized phase 3 studies PCYC-1112 (RESONATE, n = 195) and PCYC-1115/1116 (RESONATE-2, n = 135), and examined longer-term safety separately in the phase 1b/2 PCYC-1102/1103 study (n = 94, 420 mg/d). In the integrated analysis (ibrutinib treatment up to 43 months), the most common adverse events (AEs) were primarily grade 1/2; diarrhea (n = 173, 52% any-grade; n = 15, 5% grade 3) and fatigue (n = 119, 36% any-grade; n = 10, 3% grade 3). The most common grade 3/4 AEs were neutropenia (n = 60, 18%) and pneumonia (n = 38, 12%). Over time, prevalence of AEs of interest (diarrhea, fatigue, grade ≥3 infection, bleeding, and neutropenia) trended down; prevalence of hypertension increased, but incidence decreased after year 1. AEs led to dose reductions in 42 (13%) patients and permanent discontinuations in 37 (11%); dose modifications due to AEs were most common during year 1 and decreased in frequency thereafter. The most common AEs (preferred term) contributing to discontinuation included pneumonia (n = 4), anemia (n = 3), and atrial fibrillation (n = 3). With long-term follow-up on PCYC-1102/1103 (ibrutinib treatment up to 67 months), grade 3/4 AEs were generally similar to those in the integrated analysis. Overall, AEs were primarily grade 1/2 and manageable during prolonged ibrutinib treatment in patients with CLL. These trials were registered at www.clinicaltrials.gov as #NCT01578707, #NCT01722487, #NCT01724346, #NCT01105247, and #NCT01109069.",2019,"Over time, prevalence of AEs of interest (diarrhea, fatigue, grade ≥3 infection, bleeding, and neutropenia) trended down; prevalence of hypertension increased, but incidence decreased after year 1.","['chronic lymphocytic leukemia (CLL', 'patients with chronic lymphocytic leukemia in 3 pivotal studies']","['PCYC-1115/1116', 'single-agent ibrutinib']","['diarrhea', 'neutropenia', 'fatigue', 'prevalence of AEs of interest (diarrhea, fatigue, grade ≥3 infection, bleeding, and neutropenia) trended down; prevalence of hypertension', 'atrial fibrillation']","[{'cui': 'C0023434', 'cui_str': 'Chronic lymphocytic leukemia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C3501358', 'cui_str': 'Ibrutinib'}]","[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0543488', 'cui_str': 'Interested'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0040833', 'cui_str': 'trends'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}]",,0.103485,"Over time, prevalence of AEs of interest (diarrhea, fatigue, grade ≥3 infection, bleeding, and neutropenia) trended down; prevalence of hypertension increased, but incidence decreased after year 1.","[{'ForeName': 'Steven E', 'Initials': 'SE', 'LastName': 'Coutre', 'Affiliation': 'Stanford University School of Medicine, Stanford, CA.'}, {'ForeName': 'John C', 'Initials': 'JC', 'LastName': 'Byrd', 'Affiliation': 'The Ohio State University Comprehensive Cancer Center, Columbus, OH.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Hillmen', 'Affiliation': ""Leeds Cancer Centre, St. James's Institute of Oncology, Leeds, United Kingdom.""}, {'ForeName': 'Jacqueline C', 'Initials': 'JC', 'LastName': 'Barrientos', 'Affiliation': 'Hofstra Northwell School of Medicine, Hempstead, NY.'}, {'ForeName': 'Paul M', 'Initials': 'PM', 'LastName': 'Barr', 'Affiliation': 'Wilmot Cancer Institute, University of Rochester Cancer Center, Rochester, NY.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Devereux', 'Affiliation': ""King's College Hospital, National Health Service Foundation Trust, London, United Kingdom.""}, {'ForeName': 'Tadeusz', 'Initials': 'T', 'LastName': 'Robak', 'Affiliation': 'Medical University of Lodz, Lodz, Poland.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Kipps', 'Affiliation': 'Moores Cancer Center, University of California San Diego, La Jolla, CA.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Schuh', 'Affiliation': 'Oxford National Institute for Health Research Biomedical Research Centre, University of Oxford, Oxford, United Kingdom.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Moreno', 'Affiliation': 'Hospital de la Santa Creu i Sant Pau, Autonomous University of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Richard R', 'Initials': 'RR', 'LastName': 'Furman', 'Affiliation': 'Weill Cornell Medical College, New York Presbyterian Hospital, New York, NY.'}, {'ForeName': 'Jan A', 'Initials': 'JA', 'LastName': 'Burger', 'Affiliation': 'The University of Texas MD Anderson Cancer Center, Houston, TX.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': ""O'Dwyer"", 'Affiliation': 'University College Hospital Galway, Galway, Ireland.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Ghia', 'Affiliation': 'Università Vita-Salute San Raffaele and Istituto di Ricovero e Cura a Carattere Scientifico Ospedale San Raffaele, Milan, Italy.'}, {'ForeName': 'Rudolph', 'Initials': 'R', 'LastName': 'Valentino', 'Affiliation': 'Pharmacyclics LLC, an AbbVie Company, Sunnyvale, CA; and.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Chang', 'Affiliation': 'Pharmacyclics LLC, an AbbVie Company, Sunnyvale, CA; and.'}, {'ForeName': 'James P', 'Initials': 'JP', 'LastName': 'Dean', 'Affiliation': 'Pharmacyclics LLC, an AbbVie Company, Sunnyvale, CA; and.'}, {'ForeName': 'Danelle F', 'Initials': 'DF', 'LastName': 'James', 'Affiliation': 'Pharmacyclics LLC, an AbbVie Company, Sunnyvale, CA; and.'}, {'ForeName': 'Susan M', 'Initials': 'SM', 'LastName': ""O'Brien"", 'Affiliation': 'Chao Family Comprehensive Cancer Center, University of California Irvine, Irvine, CA.'}]",Blood advances,['10.1182/bloodadvances.2018028761'] 1727,32519966,Technical and Psychosocial Challenges of mHealth Usage for Antiretroviral Therapy Adherence Among People Living With HIV in a Resource-Limited Setting: Case Series.,"BACKGROUND Mobile communication has been found to improve antiretroviral therapy (ART) adherence among people living with HIV. In an ongoing randomized clinical trial, 2 mobile communication strategies (ie, sending SMS text messages and real-time medication monitoring [RTMM]) were used to improve adherence to ART among people living with HIV in Tanzania. We noticed remarkable discrepancies between self-reported adherence and adherence recorded by SMS text messaging or RTMM among some of the first trial participants. OBJECTIVE Our objective was to describe these cases and the observed discrepancies in more detail, to serve as a useful illustration of some of the challenges in using mobile health in resource-limited settings. METHODS In an ongoing randomized trial, adults living with HIV from two HIV treatment centers in Tanzania who were suspected of low levels of adherence were randomly assigned in a 1:1:1 ratio to receive (1) SMS text message reminders, (2) an RTMM device, or (3) no additional intervention to standard HIV care. During bimonthly study visits, the participants self-reported their level of adherence, received feedback about their level of adherence based on SMS text messaging or RTMM, and discussed strategies to overcome adherence problems with nurses providing HIV care. For the purpose of this report, we selected people living with HIV who had completed 5 follow-up visits and consistently reported more than 95% adherence, while SMS text messaging or RTMM recorded lower than 75% adherence. The participants were invited for a short, face-to-face in-depth interview to explore reasons for this discrepancy. RESULTS At the time of this analysis, 26 participants had completed follow-up. Six of these evidenced the above-mentioned discrepancies, with an average adherence of 46% based on SMS text messaging or RTMM, while self-reported adherence was 98%. Five of these 6 participants insisted that their adherence to ART was good, with 4 reporting that their adherence to properly using the monitoring device was low. Three participants mentioned concerns about involuntary disclosure of HIV status as a main reason for low adherence to using the device. Two participants were still depending on other reminder cues despite receiving SMS text message or RTMM reminders. Poor network coverage caused low adherence in 1 participant. CONCLUSIONS Psychosocial barriers were reported as importantly contributing to low adherence, both with respect to use of ART and proper use of the adherence-monitoring device. This case series illustrates that when introducing new digital adherence monitoring technology, researchers should consider psychosocial barriers and distinguish between adherence to device use and adherence to treatment. TRIAL REGISTRATION Pan African Clinical Trials Registry PACTR201712002844286; https://tinyurl.com/y98q4p3l.",2020,Three participants mentioned concerns about involuntary disclosure of HIV status as a main reason for low adherence to using the device.,"['selected people living with HIV who had completed 5 follow-up visits and consistently reported more than 95% adherence, while SMS text messaging or RTMM recorded lower than 75% adherence', 'Two participants were still depending on other reminder cues despite receiving SMS text message or RTMM reminders', 'People Living With HIV in a Resource-Limited Setting', '26 participants had completed follow-up', 'people living with HIV in Tanzania', 'people living with HIV', 'adults living with HIV from two HIV treatment centers in Tanzania who were suspected of low levels of adherence']","['mobile communication strategies (ie, sending SMS text messages and real-time medication monitoring [RTMM', 'SMS text message reminders, (2) an RTMM device, or (3) no additional intervention to standard HIV care', 'Antiretroviral Therapy']",[],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0589121', 'cui_str': 'Follow-up visit'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0039298', 'cui_str': 'Tanzania'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]","[{'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0085421', 'cui_str': 'Medication monitoring'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}]",[],2.0,0.136054,Three participants mentioned concerns about involuntary disclosure of HIV status as a main reason for low adherence to using the device.,"[{'ForeName': 'Kennedy Michael', 'Initials': 'KM', 'LastName': 'Ngowi', 'Affiliation': 'Kilimanjaro Clinical Research Institute, Kilimanjaro Christian Medical Centre, Moshi, United Republic of Tanzania.'}, {'ForeName': 'Furaha', 'Initials': 'F', 'LastName': 'Lyamuya', 'Affiliation': 'Kilimanjaro Christian Medical Centre, Moshi, United Republic of Tanzania.'}, {'ForeName': 'Blandina T', 'Initials': 'BT', 'LastName': 'Mmbaga', 'Affiliation': 'Kilimanjaro Clinical Research Institute, Kilimanjaro Christian Medical Centre, Moshi, United Republic of Tanzania.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Muro', 'Affiliation': 'Kilimanjaro Christian Medical Centre, Moshi, United Republic of Tanzania.'}, {'ForeName': 'Zawadiel', 'Initials': 'Z', 'LastName': 'Hillu', 'Affiliation': 'Kilimanjaro Christian Medical Centre, Moshi, United Republic of Tanzania.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Shirima', 'Affiliation': 'Majengo Dispensary, Moshi, United Republic of Tanzania.'}, {'ForeName': 'Rob E', 'Initials': 'RE', 'LastName': 'Aarnoutse', 'Affiliation': 'Radboud Institute for Health Sciences & Department of Pharmacy, Radboud University Medical Center, Nijmegen, Netherlands.'}, {'ForeName': 'Mirjam', 'Initials': 'M', 'LastName': 'Ag Sprangers', 'Affiliation': 'Department of Medical Psychology, Amsterdam University Medical Centers, Amsterdam, Netherlands.'}, {'ForeName': 'Pythia T', 'Initials': 'PT', 'LastName': 'Nieuwkerk', 'Affiliation': 'Department of Medical Psychology, Amsterdam University Medical Centers, Amsterdam, Netherlands.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Reiss', 'Affiliation': 'Department of Global Health and Division of infectious Diseases, Amsterdam institute of Global Health and Development, Amsterdam University Medical Centers, Amsterdam, Netherlands.'}, {'ForeName': 'Marion', 'Initials': 'M', 'LastName': 'Sumari-de Boer', 'Affiliation': 'Kilimanjaro Clinical Research Institute, Kilimanjaro Christian Medical Centre, Moshi, United Republic of Tanzania.'}]",JMIR formative research,['10.2196/14649'] 1728,32519972,Continuous Monitoring of Vital Signs in the General Ward Using Wearable Devices: Randomized Controlled Trial.,"BACKGROUND Wearable devices can be used for continuous patient monitoring in the general ward, increasing patient safety. Little is known about the experiences and expectations of patients and health care professionals regarding continuous monitoring with these devices. OBJECTIVE This study aimed to identify positive and negative effects as well as barriers and facilitators for the use of two wearable devices: ViSi Mobile (VM) and HealthPatch (HP). METHODS In this randomized controlled trial, 90 patients admitted to the internal medicine and surgical wards of a university hospital in the Netherlands were randomly assigned to continuous vital sign monitoring using VM or HP and a control group. Users' experiences and expectations were addressed using semistructured interviews. Nurses, physician assistants, and medical doctors were also interviewed. Interviews were analyzed using thematic content analysis. Psychological distress was assessed using the State Trait Anxiety Inventory and the Pain Catastrophizing Scale. The System Usability Scale was used to assess the usability of both devices. RESULTS A total of 60 patients, 20 nurses, 3 physician assistants, and 6 medical doctors were interviewed. We identified 47 positive and 30 negative effects and 19 facilitators and 36 barriers for the use of VM and HP. Frequently mentioned topics included earlier identification of clinical deterioration, increased feelings of safety, and VM lines and electrodes. No differences related to psychological distress and usability were found between randomization groups or devices. CONCLUSIONS Both devices were well received by most patients and health care professionals, and the majority of them encouraged the idea of monitoring vital signs continuously in the general ward. This comprehensive overview of barriers and facilitators of using wireless devices may serve as a guide for future researchers, developers, and health care institutions that consider implementing continuous monitoring in the ward. TRIAL REGISTRATION Clinicaltrials.gov NCT02933307; http://clinicaltrials.gov/ct2/show/NCT02933307.",2020,"No differences related to psychological distress and usability were found between randomization groups or devices. ","['90 patients admitted to the internal medicine and surgical wards of a university hospital in the Netherlands', '60 patients, 20 nurses, 3 physician assistants, and 6 medical doctors were interviewed']","['Wearable Devices', 'continuous vital sign monitoring using VM or HP and a control group', 'two wearable devices: ViSi Mobile (VM) and HealthPatch (HP']","['feelings of safety, and VM lines and electrodes', 'State Trait Anxiety Inventory and the Pain Catastrophizing Scale', 'Psychological distress', 'psychological distress and usability']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0021782', 'cui_str': 'Internal medicine'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0031833', 'cui_str': 'Physician assistant'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}]","[{'cui': 'C4505348', 'cui_str': 'Wearable Technology'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0013812', 'cui_str': 'Electrode'}, {'cui': 'C0683457', 'cui_str': 'State-trait anger expression inventory'}, {'cui': 'C3178745', 'cui_str': 'Pain Catastrophizing'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0815107', 'cui_str': 'Emotional Distress'}]",90.0,0.0887291,"No differences related to psychological distress and usability were found between randomization groups or devices. ","[{'ForeName': 'Mariska', 'Initials': 'M', 'LastName': 'Weenk', 'Affiliation': 'Radboud University Medical Center, Nijmegen, Netherlands.'}, {'ForeName': 'Sebastian J', 'Initials': 'SJ', 'LastName': 'Bredie', 'Affiliation': 'Radboud University Medical Center, Nijmegen, Netherlands.'}, {'ForeName': 'Mats', 'Initials': 'M', 'LastName': 'Koeneman', 'Affiliation': 'Radboud University Medical Center, Nijmegen, Netherlands.'}, {'ForeName': 'Gijs', 'Initials': 'G', 'LastName': 'Hesselink', 'Affiliation': 'Radboud University Medical Center, Nijmegen, Netherlands.'}, {'ForeName': 'Harry', 'Initials': 'H', 'LastName': 'van Goor', 'Affiliation': 'Radboud University Medical Center, Nijmegen, Netherlands.'}, {'ForeName': 'Tom H', 'Initials': 'TH', 'LastName': 'van de Belt', 'Affiliation': 'Radboud University Medical Center, Nijmegen, Netherlands.'}]",Journal of medical Internet research,['10.2196/15471'] 1729,32520132,Surgical cricothyroidostomy. Analysis and comparison between teaching and validation models of simulator models.,"OBJECTIVE to compare the acquisition and retention of knowledge about surgical cricothyroidostomy by the rapid four-step technique (RFST), when taught by expository lecture, low fidelity and high-fidelity simulation models. METHODS ninety medical students at UFPR in the first years of training were randomized assigned into 3 groups, submitted to different teaching methods: 1) expository lectures, 2) low-fidelity simulator model, developed by the research team or 3) high-fidelity simulator model (commercial). The procedure chosen was surgical cricothyroidostomy using the RFST. Soon after lectures, the groups were submitted to a multiple-choice test with 20 questions (P1). Four months later, they underwent another test (P2) with similar content. Analysis of Variance was used to compare the grades of each group in P1 with their grades in P2, and the grades of the 3 groups 2 by 2 in P1 and P2. A multiple comparisons test (post-hoc) was used to check differences within each factor (test and group). Statistical significance was considered when p<0.05. Statistical analysis was performed in the statistical software R version 3.6.1. RESULTS each group was composed of 30 medical students, without demographic differences between them. The mean scores of the groups of the expositive lecture, of the simulator of low fidelity model and of high-fidelity simulator model in P1 were, respectively, 75.00, 76.09, and 68.79, (p<0.05). In P2 the grades were 69.84, 75.32, 69.46, respectively, (p>0.05). CONCLUSIONS the simulation of low fidelity model was more effective in learning and knowledge retention, being feasible for RFST cricothyroidostomy training in inexperienced students.",2020,"In P2 the grades were 69.84, 75.32, 69.46, respectively, (p>0.05). ",['ninety medical students at UFPR in the first years of training'],"['RFST cricothyroidostomy training', 'expository lectures, 2) low-fidelity simulator model, developed by the research team or 3) high-fidelity simulator model (commercial', 'Surgical cricothyroidostomy']",[],"[{'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0038495', 'cui_str': 'Medical student'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0396429', 'cui_str': 'Cricothyroidotomy'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0376683', 'cui_str': 'Lectures'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0183309', 'cui_str': 'Simulator'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}]",[],90.0,0.0201946,"In P2 the grades were 69.84, 75.32, 69.46, respectively, (p>0.05). ","[{'ForeName': 'Akihito Inca Atahualpa', 'Initials': 'AIA', 'LastName': 'Urdiales', 'Affiliation': '- Hospital do Trabalhador/Federal University of Paraná, Department of Integrated Medicine - Curitiba - PR - Brazil.'}, {'ForeName': 'Gabriela Tulio', 'Initials': 'GT', 'LastName': 'Struck', 'Affiliation': '- Federal University of Paraná, Medical Course - Curitiba - PR - Brazil.'}, {'ForeName': 'Camila Roginski', 'Initials': 'CR', 'LastName': 'Guetter', 'Affiliation': '- Federal University of Paraná, Medical Course - Curitiba - PR - Brazil.'}, {'ForeName': 'Cecilia Hissai', 'Initials': 'CH', 'LastName': 'Yaegashi', 'Affiliation': '- Cajuru University Hospital- Pontifical Catholic University of Paraná, Department of Surgery - Curitiba - PR - Brazil.'}, {'ForeName': 'Kassio Silva', 'Initials': 'KS', 'LastName': 'Temperly', 'Affiliation': '- Pontifical Catholic University of Paraná, Course of Medicina - Curitiba - PR - Brazil.'}, {'ForeName': 'Phillipe', 'Initials': 'P', 'LastName': 'Abreu', 'Affiliation': '- Hospital do Trabalhador/Federal University of Paraná, Department of Surgery - Curitiba - PR - Brazil.'}, {'ForeName': 'Flavio Saavedra', 'Initials': 'FS', 'LastName': 'Tomasich', 'Affiliation': '- Hospital do Trabalhador/Federal University of Paraná, Department of Surgery - Curitiba - PR - Brazil.'}, {'ForeName': 'Antônio Carlos Ligocki', 'Initials': 'ACL', 'LastName': 'Campos', 'Affiliation': '- Federal University of Paraná, Postgraduate Program in Surgical Clinic - Curitiba - PR - Brazil.'}]",Revista do Colegio Brasileiro de Cirurgioes,['10.1590/0100-6991e-20202522'] 1730,32521538,"Colon-delivered short-chain fatty acids attenuate the cortisol response to psychosocial stress in healthy men: a randomized, placebo-controlled trial.","Short-chain fatty acids (SCFAs) are products of microbial fermentation of dietary fiber in the colon and may mediate microbiota-gut-brain communication. However, their role in modulating psychobiological processes that underlie the development of stress- and anxiety-related disorders is not mechanistically studied in humans. In this triple-blind, randomized, placebo-controlled intervention trial, we examine in a parallel group design the effects of 1-week colonic SCFA-mixture delivery in doses equivalent to fermentation of 10 g or 20 g of arabinoxylan oligosaccharides on responses to psychosocial stress and fear tasks in 66 healthy men. We demonstrate that low and high doses of SCFAs significantly attenuate the cortisol response to psychosocial stress compared to placebo. Both doses of SCFAs increase serum SCFA levels and this increase in circulating SCFAs co-varies significantly with the attenuation of the cortisol response to psychosocial stress. Colonic SCFA delivery does not modulate fecal SCFA concentrations, serum brain-derived neurotrophic factor, cortisol awakening response, fear learning and extinction, or subjective mood ratings. These results demonstrate that colon-delivered SCFAs modulate hypothalamic-pituitary-adrenal axis reactivity to psychosocial stress, thereby supporting their hypothesized role in microbiota-gut-brain communication.",2020,"Colonic SCFA delivery does not modulate fecal SCFA concentrations, serum brain-derived neurotrophic factor, cortisol awakening response, fear learning and extinction, or subjective mood ratings.","['healthy men', '66 healthy men']","['Short-chain fatty acids (SCFAs', 'colonic SCFA-mixture delivery', 'SCFAs', 'Colon-delivered short-chain fatty acids', 'arabinoxylan oligosaccharides', 'placebo']","['fecal SCFA concentrations, serum brain-derived neurotrophic factor, cortisol awakening response, fear learning and extinction, or subjective mood ratings', 'cortisol response to psychosocial stress', 'serum SCFA levels']","[{'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0015691', 'cui_str': 'Short chain fatty acid'}, {'cui': 'C0009368', 'cui_str': 'Colonic'}, {'cui': 'C0439962', 'cui_str': 'Mixture'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0250438', 'cui_str': 'arabinoxylan'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0015691', 'cui_str': 'Short chain fatty acid'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C1720052', 'cui_str': 'Awakening'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0015347', 'cui_str': 'Psychological Extinction'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",66.0,0.031091,"Colonic SCFA delivery does not modulate fecal SCFA concentrations, serum brain-derived neurotrophic factor, cortisol awakening response, fear learning and extinction, or subjective mood ratings.","[{'ForeName': 'Boushra', 'Initials': 'B', 'LastName': 'Dalile', 'Affiliation': 'Translational Research Center in Gastrointestinal Disorders (TARGID), Department of Chronic Diseases, Metabolism, and Ageing, Faculty of Medicine, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Bram', 'Initials': 'B', 'LastName': 'Vervliet', 'Affiliation': 'Laboratory of Biological Psychology, Brain & Cognition, Faculty of Psychology and Educational Sciences, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Gabriela', 'Initials': 'G', 'LastName': 'Bergonzelli', 'Affiliation': 'Department of Gastrointestinal Health, Nestlé Research, Société des Produits Nestlé S.A., Lausanne, Switzerland.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Verbeke', 'Affiliation': 'Translational Research Center in Gastrointestinal Disorders (TARGID), Department of Chronic Diseases, Metabolism, and Ageing, Faculty of Medicine, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Lukas', 'Initials': 'L', 'LastName': 'Van Oudenhove', 'Affiliation': 'Translational Research Center in Gastrointestinal Disorders (TARGID), Department of Chronic Diseases, Metabolism, and Ageing, Faculty of Medicine, KU Leuven, Leuven, Belgium. lukas.vanoudenhove@kuleuven.be.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-020-0732-x'] 1731,32522090,Decision Regret among Informal Caregivers Making Housing Decisions for Older Adults with Cognitive Impairment: A Cross-sectional Analysis.,"Background . Informal caregivers are regularly faced with difficult housing decisions for older adults with cognitive impairment. They often regret the decision they made. We aimed to identify factors associated with decision regret among informal caregivers engaging in housing decisions for cognitively impaired older adults. Methods . We performed a secondary analysis of cross-sectional data collected from a cluster-randomized trial. Eligible participants were informal caregivers involved in making housing decisions for cognitively impaired older adults. Decision regret was assessed after caregivers' enrollment in the study using the Decision Regret Scale (DRS), scored from 0 to 100. We used a conceptual framework of potential predictors of regret to identify independent variables. We performed multilevel analyses using a mixed linear model by estimating fixed effects (β) and 95% confidence intervals (CIs). Results . The mean (SD) DRS score of 296 informal caregivers (mean [SD] age, 62 [12] years) was 12.4 (18.4). Factors associated with less decision regret were having a college degree compared to primary education (β [95% CI]: -11.14 [-18.36, -3.92]), being married compared to being single (-5.60 [-10.05, -1.15]), informal caregivers' perception that a joint process occurred (-0.14 [-0.25, -0.02]), and older adults' not having a specific housing preference compared to preferring to stay at home (-4.13 [-7.40, -0.86]). Factors associated with more decision regret were being retired compared to being a homemaker (7.74 [1.32, 14.16]), higher burden of care (0.14 [0.05, 0.22]), and higher decisional conflict (0.51 [0.34, 0.67]). Limitations . Our analysis may not illustrate all predictors of decision regret among informal caregivers. Conclusions . Our findings will allow risk-mitigation strategies for informal caregivers at risk of experiencing regret.",2020,"Factors associated with more decision regret were being retired compared to being a homemaker (7.74 [1.32, 14.16]), higher burden of care (0.14 [0.05, 0.22]), and higher decisional conflict (0.51 [0.34, 0.67]). ","['Older Adults with Cognitive Impairment', 'older adults with cognitive impairment', 'Eligible participants were informal caregivers involved in making housing decisions for cognitively impaired older adults', 'cognitively impaired older adults']",[],"['mean (SD) DRS score', 'decision regret', ""informal caregivers' perception that a joint process"", 'higher burden of care', 'Decision regret', 'higher decisional conflict', 'Decision Regret Scale (DRS']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}, {'cui': 'C1319882', 'cui_str': 'Informal caregiver'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0020056', 'cui_str': 'Housed'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}]",[],"[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0013261', 'cui_str': ""Duane's syndrome""}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0080101', 'cui_str': 'Regret'}, {'cui': 'C1319882', 'cui_str': 'Informal caregiver'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0231394', 'cui_str': 'Decisional conflict'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",,0.118618,"Factors associated with more decision regret were being retired compared to being a homemaker (7.74 [1.32, 14.16]), higher burden of care (0.14 [0.05, 0.22]), and higher decisional conflict (0.51 [0.34, 0.67]). ","[{'ForeName': 'Hélène', 'Initials': 'H', 'LastName': 'Elidor', 'Affiliation': 'VITAM - Centre de recherche en santé durable, Quebec, QC, Canada.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Ben Charif', 'Affiliation': 'VITAM - Centre de recherche en santé durable, Quebec, QC, Canada.'}, {'ForeName': 'Codjo Djignefa', 'Initials': 'CD', 'LastName': 'Djade', 'Affiliation': 'VITAM - Centre de recherche en santé durable, Quebec, QC, Canada.'}, {'ForeName': 'Rhéda', 'Initials': 'R', 'LastName': 'Adekpedjou', 'Affiliation': 'VITAM - Centre de recherche en santé durable, Quebec, QC, Canada.'}, {'ForeName': 'France', 'Initials': 'F', 'LastName': 'Légaré', 'Affiliation': 'VITAM - Centre de recherche en santé durable, Quebec, QC, Canada.'}]",Medical decision making : an international journal of the Society for Medical Decision Making,['10.1177/0272989X20925368'] 1732,32522591,Mothers' DASH diet adherence and food purchases after week-long episodic future thinking intervention.,"Prospection has helped participants forego the temptation to buy and eat higher calorie nutrient poor foods in favor of buying and eating fewer calories and healthier macronutrient profiles in laboratory tasks and brief field studies. This pilot study examines whether episodic future thinking (EFT) improves mothers' dietary behavior and food purchasing over a longer 7-10-day period. The study utilized a 2 × 2 factorial design with mothers (N = 60) randomized to EFT or standardized episodic thinking (SET) crossed with dietary approaches to stop hypertension (DASH) diet education or a food safety education control. Participants listened to their cues (e.g., recordings of themselves imagining a future event or recalling a past episode) using a mobile ecological momentary intervention (EMI) tool and returned to complete a follow-up dietary recall and submit food receipts. Results showed diets of mothers in the EFT groups became more concordant with the DASH diet (η p 2  = 0.08, p < .05) than mothers in the SET group. When considering food purchases for the family, there was an EFT effect on milligrams of sodium purchased (η p 2  = 0.07, p < .05) and a trend towards a decrease in grams of fat purchased (η p 2  = 0.06, p = .06), however, these findings were no longer significant after correcting for multiple comparisons. There were no DASH education effects and no DASH by EFT interactions observed. The dietary intake and food purchasing results should be replicated in larger more representative samples.",2020,"Results showed diets of mothers in the EFT groups became more concordant with the DASH diet (η p 2  = 0.08, p < .05) than mothers in the SET group.",['2\u202f×\u202f2 factorial design with mothers (N\u202f=\u202f60) randomized to'],"['episodic future thinking (EFT', 'EFT or standardized episodic thinking (SET) crossed with dietary approaches to stop hypertension (DASH) diet education or a food safety education control', 'mobile ecological momentary intervention (EMI) tool and returned to complete a follow-up dietary recall and submit food receipts']","['DASH education effects', ""mothers' dietary behavior and food purchasing"", 'grams of fat purchased']","[{'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0026591', 'cui_str': 'Mother'}]","[{'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0016884', 'cui_str': 'Future'}, {'cui': 'C0205203', 'cui_str': 'Crossed'}, {'cui': 'C4053458', 'cui_str': 'Dietary Approaches to Stop Hypertension diet'}, {'cui': 'C0204932', 'cui_str': 'Diet education'}, {'cui': 'C1456535', 'cui_str': 'Food Safety'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C0016452', 'cui_str': 'Foods'}]","[{'cui': 'C4053458', 'cui_str': 'Dietary Approaches to Stop Hypertension diet'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0439208', 'cui_str': 'g'}, {'cui': 'C0015677', 'cui_str': 'Fat'}]",60.0,0.0401892,"Results showed diets of mothers in the EFT groups became more concordant with the DASH diet (η p 2  = 0.08, p < .05) than mothers in the SET group.","[{'ForeName': 'Kelseanna', 'Initials': 'K', 'LastName': 'Hollis-Hansen', 'Affiliation': 'Department of Population Health, University of Texas at Austin, Dell Medical School, Austin, TX, USA; University of Texas at Austin, Steve Hicks School of Social Work, Austin, TX, USA. Electronic address: kelseanna.hollishansen@austin.utexas.edu.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Seidman', 'Affiliation': 'Department of Pediatrics, Division of Behavioral Medicine, University at Buffalo, Jacobs School of Medicine and Biomedical Sciences, Buffalo, NY, USA.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': ""O'Donnell"", 'Affiliation': 'Department of Pediatrics, Division of Behavioral Medicine, University at Buffalo, Jacobs School of Medicine and Biomedical Sciences, Buffalo, NY, USA.'}, {'ForeName': 'Leonard H', 'Initials': 'LH', 'LastName': 'Epstein', 'Affiliation': 'Department of Pediatrics, Division of Behavioral Medicine, University at Buffalo, Jacobs School of Medicine and Biomedical Sciences, Buffalo, NY, USA.'}]",Appetite,['10.1016/j.appet.2020.104757'] 1733,32524612,Impact of Labeled Glasses in a Bar Laboratory Setting: No Effect on Ad Libitum Alcohol Consumption.,"AIMS Information provided on glass labels may be an effective method to reduce alcohol consumption. The aim of this study was to assess the impact of glass labels conveying unit information and a health warning in reducing ad libitum alcohol consumption. METHODS A cluster-randomized experimental study was conducted to measure the efficacy of a labeled glass in reducing alcohol consumption in a semi naturalistic bar laboratory setting, in a sample of 81 pairs (n = 162) of UK young adult drinkers. Pairs were randomized to receive two 340-ml glasses of beer or wine: labeled or plain (control). Alcohol consumption was assessed in an ad libitum drinking period, and urge to drink was measured at baseline and postdrinking period. Focus groups (n = 2) were conducted, and thematic analysis was used to gain an insight into the acceptability and the perceived effectiveness of the glasses. RESULTS Mean unit consumption was 1.62 (SD ± 0.83) units in the labeled glass condition and 1.69 (SD ± 0.82) units in the non labeled glass condition. There were no significant effects of the labeled glasses on ad libitum alcohol consumption (95% CI -0.25 to 0.37, p = 0.35), despite participants (85%) noticing the information. Qualitative analysis of focus groups indicated that although participants perceived the glasses as a useful tool for increasing awareness of units and guidelines, they were viewed as limited in their potential to change drinking behavior due to the unappealing design of the glass and a view that unit guidelines were not relevant to drinking patterns or contexts. CONCLUSIONS Labeled glasses did not change alcohol consumption in the current study, potentially due to ineffectiveness of this type of message in a young adult population. The information on the glasses was attended to, highlighting that glasses could be a feasible tool for providing information.",2020,"Qualitative analysis of focus groups indicated that although participants perceived the glasses as a useful tool for increasing awareness of units and guidelines, they were viewed as limited in their potential to change drinking behaviour due to the unappealing design of the glass and a view that unit guidelines were not relevant to drinking patterns or contexts. ","['a semi-naturalistic bar-laboratory setting, in a sample of 81 pairs (n = 162) of UK young adult drinkers']","['labelled glass', '340 ml glasses of beer or wine: labelled or plain (control', 'labelled glasses']","['alcohol consumption', 'Mean unit consumption', 'labelled glasses on ad libitum alcohol consumption', 'Alcohol consumption']","[{'cui': 'C0001643', 'cui_str': 'Beta-2 adrenergic receptor'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C5191360', 'cui_str': '162'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C0015421', 'cui_str': 'Eyeglasses'}, {'cui': 'C4517730', 'cui_str': '340'}, {'cui': 'C0004922', 'cui_str': 'Beer'}, {'cui': 'C0043188', 'cui_str': 'Wine'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0015421', 'cui_str': 'Eyeglasses'}]",2.0,0.0811205,"Qualitative analysis of focus groups indicated that although participants perceived the glasses as a useful tool for increasing awareness of units and guidelines, they were viewed as limited in their potential to change drinking behaviour due to the unappealing design of the glass and a view that unit guidelines were not relevant to drinking patterns or contexts. ","[{'ForeName': 'Natasha', 'Initials': 'N', 'LastName': 'Clarke', 'Affiliation': 'From the, University of Cambridge Institute of Public Health, (NC), Cambridge, UK.'}, {'ForeName': 'Abigail K', 'Initials': 'AK', 'LastName': 'Rose', 'Affiliation': 'Department of Psychological Sciences, (NC, AKR), University of Liverpool, Liverpool, UK.'}]","Alcoholism, clinical and experimental research",['10.1111/acer.14392'] 1734,32525452,Analysis of Scapular Muscle EMG Activity During Elastic Resistance Oscillation Exercises From the Perspective of Different Arm Positions.,"BACKGROUND Little is known about the optimal exercise intensity and the effects of arm position on elastic resistance exercise. The purpose of this study was to investigate scapular muscle activity in different arm positions utilized during standing elastic resistance exercise. HYPOTHESIS Lower trapezius (LT), serratus anterior (SA), and infraspinatus (IS) muscle activity will vary across arm positions above shoulder level. Also, oscillation resistance exercise will result in increased muscle activity compared with isometric contraction. STUDY DESIGN Controlled laboratory study. LEVEL OF EVIDENCE Level 4. METHODS A total of 19 uninjured male collegiate baseball players volunteered to participate in this study. The electromyography (EMG) activity of the LT, upper trapezius (UT), middle deltoid (MD), SA, and IS muscles was determined using surface EMG in 3 arm positions: diagonal pattern 1 (D1), 120° of shoulder abduction (120), and 90° shoulder abduction with external rotation and elbow flexion (90/90) during both isometric contraction and oscillation resistance exercise. RESULTS No difference in EMG activity of the LT muscle was found between the 120 and 90/90 position. However, the 120 position increased UT and MD muscle activity significantly more than those of the 90/90 position. The D1 arm position significantly increased SA muscle activity more than the 120 and 90/90 positions while the LT muscle activity was nearly silent. CONCLUSION The standing 90/90 position effectively generated both LT and IS muscle EMG activity while minimizing both UT and MD muscle activity. CLINICAL RELEVANCE The use of oscillation movements under elastic loading can create high muscle activation in the LT muscle without an adverse effect of the humeral head position and scapular rotation.",2020,"The standing 90/90 position effectively generated both LT and IS muscle EMG activity while minimizing both UT and MD muscle activity. ",['19 uninjured male collegiate baseball players volunteered to participate in this study'],"['90° shoulder abduction with external rotation and elbow flexion (90/90) during both isometric contraction and oscillation resistance exercise', 'Elastic Resistance Oscillation Exercises']","['UT and MD muscle activity', 'Lower trapezius (LT), serratus anterior (SA), and infraspinatus (IS) muscle activity', 'scapular muscle activity', 'muscle activity', 'EMG activity of the LT muscle', 'LT muscle activity', 'SA muscle activity', 'Scapular Muscle EMG Activity', 'electromyography (EMG) activity of the LT, upper trapezius (UT), middle deltoid (MD), SA, and IS muscles']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0004795', 'cui_str': 'Baseball'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0086505', 'cui_str': 'Kidnapping'}, {'cui': 'C0231462', 'cui_str': 'External rotation'}, {'cui': 'C0013769', 'cui_str': 'Elbow region structure'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0022205', 'cui_str': 'Muscle isometric contraction'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0221839', 'cui_str': 'Orthodontic band, elastic'}]","[{'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0224361', 'cui_str': 'Structure of trapezius muscle'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0224234', 'cui_str': 'Structure of deltoid muscle'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0224349', 'cui_str': 'Structure of serratus anterior muscle'}, {'cui': 'C0584882', 'cui_str': 'Infraspinatus muscle structure'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0013839', 'cui_str': 'Electromyography'}]",19.0,0.0260439,"The standing 90/90 position effectively generated both LT and IS muscle EMG activity while minimizing both UT and MD muscle activity. ","[{'ForeName': 'Masaaki', 'Initials': 'M', 'LastName': 'Tsuruike', 'Affiliation': 'Department of Kinesiology, College of Health and Human Sciences, San José State University, San Jose, California.'}, {'ForeName': 'Todd S', 'Initials': 'TS', 'LastName': 'Ellenbecker', 'Affiliation': 'Rehab Plus Sports Therapy Scottsdale and ATP Tour, Scottsdale, Arizona.'}, {'ForeName': 'Yoshinori', 'Initials': 'Y', 'LastName': 'Kagaya', 'Affiliation': 'School of Nursing and Rehabilitation Sciences, Showa University, Yokohama, Kanagawa Prefecture, Japan.'}, {'ForeName': 'Luke', 'Initials': 'L', 'LastName': 'Lemings', 'Affiliation': 'Conte Sport Performance Therapy, Scottsdale, Arizona.'}]",Sports health,['10.1177/1941738120929305'] 1735,32526225,The effect of HF-rTMS over the left DLPFC on stress regulation as measured by cortisol and heart rate variability.,"The prefrontal cortex, and especially the Dorsolateral Prefrontal Cortex (DLPFC), plays an inhibitory role in the regulation of the Hypothalamic-Pituitary-Adrenal (HPA) axis under stressful situations. Moreover, recent evidence suggests that a sustained DLPFC activation is associated with adaptive stress regulation in anticipation of a stressful event, leading to a reduced stress-induced amygdala response, and facilitating the confrontation with the stressor. However, studies using experimental manipulation of the activity of the DLPFC before a stressor are scarce, and more research is needed to understand the specific role of this brain area in the stress-induced physiological response. This pre-registered study investigated the effect on stress regulation of a single excitatory high frequency (versus sham) repetitive transcranial magnetic stimulation (HF-rTMS) session over the left DLPFC applied before the Trier Social Stress Test in 75 healthy young women (M = 21.05, SD = 2.60). Heart rate variability (HRV) and salivary cortisol were assessed throughout the experimental protocol. The active HF-rTMS and the sham group showed a similar cognitive appraisal of the stress task. No differences in HRV were observed during both the anticipation and the actual confrontation with the stress task and therefore, our results did not reflect DLPFC-related adaptive anticipatory adjustments. Importantly, participants in the active HF-rTMS group showed a lower cortisol response to stress. The effect of left prefrontal HF-rTMS on the stress system provides further critical experimental evidence for the inhibitory role played by the DLPFC in the regulation of the HPA axis.",2020,"No differences in HRV were observed during both the anticipation and the actual confrontation with the stress task and therefore, our results did not reflect DLPFC-related adaptive anticipatory adjustments.","['75 healthy young women (M\u202f=\u202f21.05, SD\u202f=\u202f2.60']","['single excitatory high frequency (versus sham) repetitive transcranial magnetic stimulation (HF-rTMS) session', 'HF-rTMS']","['HRV', 'cortisol response', 'Heart rate variability (HRV) and salivary cortisol']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205212', 'cui_str': 'High frequency'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}]","[{'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}]",75.0,0.0262171,"No differences in HRV were observed during both the anticipation and the actual confrontation with the stress task and therefore, our results did not reflect DLPFC-related adaptive anticipatory adjustments.","[{'ForeName': 'Matias M', 'Initials': 'MM', 'LastName': 'Pulopulos', 'Affiliation': 'Department of Experimental Clinical and Health Psychology, Ghent University, Belgium. Electronic address: matias.pulopulos@ugent.be.'}, {'ForeName': 'Maximilian', 'Initials': 'M', 'LastName': 'Schmausser', 'Affiliation': 'Department of Experimental Clinical and Health Psychology, Ghent University, Belgium.'}, {'ForeName': 'Stefanie', 'Initials': 'S', 'LastName': 'De Smet', 'Affiliation': 'Department of Head and Skin, Ghent University, Belgium; Ghent Experimental Psychiatry (GHEP) Lab, Belgium.'}, {'ForeName': 'Marie-Anne', 'Initials': 'MA', 'LastName': 'Vanderhasselt', 'Affiliation': 'Department of Experimental Clinical and Health Psychology, Ghent University, Belgium; Department of Head and Skin, Ghent University, Belgium; Ghent Experimental Psychiatry (GHEP) Lab, Belgium.'}, {'ForeName': 'Shishir', 'Initials': 'S', 'LastName': 'Baliyan', 'Affiliation': 'Department of Psychobiology, Universidad Nacional de Educación a Distancia (UNED), Spain.'}, {'ForeName': 'César', 'Initials': 'C', 'LastName': 'Venero', 'Affiliation': 'Department of Psychobiology, Universidad Nacional de Educación a Distancia (UNED), Spain.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Baeken', 'Affiliation': 'Department of Head and Skin, Ghent University, Belgium; Ghent Experimental Psychiatry (GHEP) Lab, Belgium; Department of Psychiatry, University Hospital Brussels (UZBrussel), Belgium; Department of Electrical Engineering, Eindhoven University of Technology, the Netherlands.'}, {'ForeName': 'Rudi', 'Initials': 'R', 'LastName': 'De Raedt', 'Affiliation': 'Department of Experimental Clinical and Health Psychology, Ghent University, Belgium.'}]",Hormones and behavior,['10.1016/j.yhbeh.2020.104803'] 1736,32533236,Bracka verses Byar's two-stage repair in proximal hypospadias associated with severe chordee: a randomized comparative study.,"INTRODUCTION Proximal hypospadias associated with severe chordee represents a major surgical challenge and the debate over its optimal treatment is ongoing. The objective of this study is to compare the outcome of two-stage Bracka and Byar's repair in proximal hypospadias. MATERIALS AND METHODS This study was conducted from January 2013 to February 2018 in a tertiary care centre. Patients of hypospadias with severe chordee who required urethral plate transection were included in the study. Patients were randomly divided into two groups by simple randomization method. Bracka staged repair was done in Group A and Byar's staged repair in Group B. Postoperatively complications including graft loss, flap necrosis, fistula formation, meatal stenosis, stricture, diverticula formation, residual chordee were noted in both the groups and compared. p value of < 0.05 was considered statistically significant. RESULTS Over a period of 5 years, 74 patients in group A and 68 patients in group B were operated. Fistula occurred in 6.8% and 10.2% in group A and group B, respectively (p value 0.629). Meatal stenosis was seen in 4% in group A and 3% in group B (p value 0.731). Stricture was seen in 1% in each group (p value 0.339). Diverticula formation was seen in 2% in group B and none of the patient in group A (p value 0.960). None of the patient had recurrence of chordee in either group. CONCLUSION Bracka and Byar's two-stage repair have similar postoperative outcome and the choice between the two depends up on the surgeon's choice and experience rather than scientific evidence.",2020,Meatal stenosis was seen in 4% in group A and 3% in group B (p value 0.731).,"['January 2013 to February 2018 in a tertiary care centre', 'Patients of hypospadias with severe chordee who required urethral plate transection', 'proximal hypospadias associated with severe chordee']","[""Bracka verses Byar's two-stage repair""]","['Fistula', 'Diverticula formation', 'graft loss, flap necrosis, fistula formation, meatal stenosis, stricture, diverticula formation, residual chordee', 'recurrence of chordee', 'Meatal stenosis', 'Stricture']","[{'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0848558', 'cui_str': 'Hypospadias'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0221182', 'cui_str': 'Chordee'}, {'cui': 'C0440785', 'cui_str': 'Urethral plate'}, {'cui': 'C0152060', 'cui_str': 'Transection'}, {'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}]","[{'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}]","[{'cui': 'C0016169', 'cui_str': 'Fistula'}, {'cui': 'C0012817', 'cui_str': 'Diverticulum'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0877042', 'cui_str': 'Graft loss'}, {'cui': 'C4075512', 'cui_str': 'Flap necrosis'}, {'cui': 'C0431750', 'cui_str': 'Pinhole meatus'}, {'cui': 'C1261287', 'cui_str': 'Stenosis'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0221182', 'cui_str': 'Chordee'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}]",,0.0473903,Meatal stenosis was seen in 4% in group A and 3% in group B (p value 0.731).,"[{'ForeName': 'Sajad Ahmad', 'Initials': 'SA', 'LastName': 'Wani', 'Affiliation': 'Consultant Paediatric Surgery and Paediatric Urology, GMC Srinagar, Married Hostel, Room No 205, Srinagar, Jammu and Kashmir, 190001, India. wanisajad862@gmail.com.'}, {'ForeName': 'Aejaz Ahsan', 'Initials': 'AA', 'LastName': 'Baba', 'Affiliation': 'Paediatric Surgery, SKIMS, Srinagar, Kashmir, India.'}, {'ForeName': 'Gowhar Nazir', 'Initials': 'GN', 'LastName': 'Mufti', 'Affiliation': 'Paediatric Surgery, SKIMS, Srinagar, Kashmir, India.'}, {'ForeName': 'Kumar Abdul', 'Initials': 'KA', 'LastName': 'Rashid', 'Affiliation': 'Consultant Paediatric Surgery and Paediatric Urology, GMC Srinagar, Married Hostel, Room No 205, Srinagar, Jammu and Kashmir, 190001, India.'}, {'ForeName': 'Nisar Ahmad', 'Initials': 'NA', 'LastName': 'Bhat', 'Affiliation': 'Paediatric Surgery, SKIMS, Srinagar, Kashmir, India.'}, {'ForeName': 'Mudasir', 'Initials': 'M', 'LastName': 'Buch', 'Affiliation': 'Registrar Paediatric Surgery, SKIMS, Srinagar, Kashmir, India.'}, {'ForeName': 'Mir', 'Initials': 'M', 'LastName': 'Faheem', 'Affiliation': 'Registrar Paediatric Surgery, SKIMS, Srinagar, Kashmir, India.'}]",Pediatric surgery international,['10.1007/s00383-020-04697-x'] 1737,30145365,Dietary and Plasma Polyunsaturated Fatty Acids Are Inversely Associated with Asthma and Atopy in Early Childhood.,"BACKGROUND Polyunsaturated fatty acids (PUFAs) influence immune function and risk of allergic disease. Prior evidence of the effect of PUFA intake on childhood asthma and allergy is inconclusive. OBJECTIVES To investigate associations of PUFA plasma levels and dietary intake with asthma and allergy at age 3 years in this ancillary study of the Vitamin D Antenatal Asthma Reduction Trial. METHODS Plasma PUFA levels were reported as relative abundances from mass spectrometry profiling, and dietary PUFA intake was derived from food frequency questionnaire responses. Associations between PUFA and outcomes, including asthma and/or recurrent wheeze, allergic sensitization, and total IgE at age 3 years, were evaluated in adjusted regression models. Additional regression models analyzed the combined effects of antenatal vitamin D and early childhood PUFA on outcomes. RESULTS Total, omega-3, and omega-6 plasma PUFA relative abundances were significantly (P < .05) inversely associated with both asthma and/or recurrent wheeze and allergic sensitization. Likewise, dietary PUFA intake was inversely associated with asthma and/or recurrent wheeze (P < .05 for omega-6 PUFA only). For both dietary and plasma measures of total, omega-3, and omega-6 PUFAs, inverse associations with outcomes were strongest among subjects with both high umbilical cord blood 25-hydroxyvitamin D and high PUFA at age 3 years. CONCLUSIONS PUFA dietary intake and plasma levels are inversely associated with asthma and/or recurrent wheeze and atopy at age 3 years. Antenatal vitamin D could modulate the effect of early childhood PUFA on risk of asthma and allergy.",2019,"RESULTS Total, omega-3, and omega-6 plasma PUFA relative abundances were significantly (P < .05) inversely associated with both asthma and/or recurrent wheeze and allergic sensitization.",['subjects with both high umbilical cord blood 25-hydroxyvitamin D and high PUFA at age 3 years'],"['Antenatal vitamin D', 'antenatal vitamin D and early childhood PUFA', 'Polyunsaturated fatty acids (PUFAs', 'PUFA intake']","['asthma and/or recurrent wheeze, allergic sensitization, and total IgE', 'Likewise, dietary PUFA intake', 'asthma and/or recurrent wheeze and allergic sensitization', 'Total, omega-3, and omega-6 plasma PUFA relative abundances', 'asthma and/or recurrent wheeze']","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0162371', 'cui_str': 'Cord blood'}, {'cui': 'C0006657', 'cui_str': 'Calcifediol'}, {'cui': 'C0032615', 'cui_str': 'Polyunsaturated fatty acid'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C2828394', 'cui_str': 'Antenatal'}, {'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0599196', 'cui_str': 'Early childhood'}, {'cui': 'C0032615', 'cui_str': 'Polyunsaturated fatty acid'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}]","[{'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0043144', 'cui_str': 'Wheezing'}, {'cui': 'C3662483', 'cui_str': 'Allergic sensitization'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0020846', 'cui_str': 'Immunoglobulin E'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0032615', 'cui_str': 'Polyunsaturated fatty acid'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C1719844', 'cui_str': 'Omega'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0080103', 'cui_str': 'Relative'}]",,0.0332669,"RESULTS Total, omega-3, and omega-6 plasma PUFA relative abundances were significantly (P < .05) inversely associated with both asthma and/or recurrent wheeze and allergic sensitization.","[{'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Lee-Sarwar', 'Affiliation': ""Division of Rheumatology, Immunology and Allergy, Brigham and Women's Hospital and Harvard Medical School, Boston, Mass; Channing Division of Network Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Mass. Electronic address: klee-sarwar@partners.org.""}, {'ForeName': 'Rachel S', 'Initials': 'RS', 'LastName': 'Kelly', 'Affiliation': ""Channing Division of Network Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Mass.""}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Lasky-Su', 'Affiliation': ""Channing Division of Network Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Mass.""}, {'ForeName': 'Priyadarshini', 'Initials': 'P', 'LastName': 'Kachroo', 'Affiliation': ""Channing Division of Network Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Mass.""}, {'ForeName': 'Robert S', 'Initials': 'RS', 'LastName': 'Zeiger', 'Affiliation': 'Departments of Allergy and Research and Evaluation, Kaiser Permanente Southern California, San Diego and Pasadena, Calif.'}, {'ForeName': 'George T', 'Initials': 'GT', 'LastName': ""O'Connor"", 'Affiliation': 'Pulmonary Center and Department of Medicine, Boston University School of Medicine, Boston, Mass.'}, {'ForeName': 'Megan T', 'Initials': 'MT', 'LastName': 'Sandel', 'Affiliation': 'Department of Pediatrics, Boston Medical Center, Boston, Mass.'}, {'ForeName': 'Leonard B', 'Initials': 'LB', 'LastName': 'Bacharier', 'Affiliation': ""Division of Pediatric Allergy, Immunology and Pulmonary Medicine, Department of Pediatrics, Washington University School of Medicine, and St Louis Children's Hospital, St Louis, Mo.""}, {'ForeName': 'Avraham', 'Initials': 'A', 'LastName': 'Beigelman', 'Affiliation': ""Division of Pediatric Allergy, Immunology and Pulmonary Medicine, Department of Pediatrics, Washington University School of Medicine, and St Louis Children's Hospital, St Louis, Mo.""}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Laranjo', 'Affiliation': ""Channing Division of Network Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Mass.""}, {'ForeName': 'Diane R', 'Initials': 'DR', 'LastName': 'Gold', 'Affiliation': ""Channing Division of Network Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Mass; Department of Environmental Health, Harvard T.H. Chan School of Public Health, Boston, Mass.""}, {'ForeName': 'Scott T', 'Initials': 'ST', 'LastName': 'Weiss', 'Affiliation': ""Channing Division of Network Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Mass.""}, {'ForeName': 'Augusto A', 'Initials': 'AA', 'LastName': 'Litonjua', 'Affiliation': ""Division of Pediatric Pulmonary Medicine, Golisano Children's Hospital at University of Rochester Medical Center, Rochester, New York, NY. Electronic address: augusto_litonjua@urmc.rochester.edu.""}]",The journal of allergy and clinical immunology. In practice,['10.1016/j.jaip.2018.07.039'] 1738,32539487,Cognition test battery: Adjusting for practice and stimulus set effects for varying administration intervals in high performing individuals.,"INTRODUCTION Practice effects associated with the repeated administration of cognitive tests often confound true therapeutic or experimental effects. Alternate test forms help reduce practice effects, but generating stimulus sets with identical properties can be difficult. The main objective of this study was to disentangle practice and stimulus set effects for Cognition , a battery of 10 brief cognitive tests specifically designed for high-performing populations with 15 unique versions for repeated testing. A secondary objective was to investigate the effects of test-retest interval on practice effects. METHODS The 15 versions of Cognition were administered in three groups of 15-16 subjects (total N = 46, mean±SD age 32.5 ± 7.2 years, range 25-54 years, 23 male) in a randomized but balanced fashion with administration intervals of ≥10 days, ≤5 days, or 4 times per day. Mixed effect models were used to investigate linear and logarithmic trends across repeated administrations in key speed and accuracy outcomes, whether these trends differed significantly between administration interval groups, and whether stimulus sets differed significantly in difficulty. RESULTS Protracted, non-linear practice effects well beyond the second administration were observed for most of the 10 Cognition tests both in accuracy and speed, but test-retest administration interval significantly affected practice effects only for 3 out of the 10 tests and only in the speed domain. Stimulus set effects were observed for the 6 Cognition tests that use unique sets of stimuli. Factors were established that allow for correcting for both practice and stimulus set effects. CONCLUSIONS Practice effects are pronounced and probably under-appreciated in cognitive testing. The correction factors established in this study are a unique feature of the Cognition battery that can help avoid masking practice effects, address noise generated by differences in stimulus set difficulty, and facilitate interpretation of results from studies with repeated assessments.",2020,"RESULTS Protracted, non-linear practice effects well beyond the second administration were observed for most of the 10 Cognition tests both in accuracy and speed, but test-retest administration interval significantly affected practice effects only for 3 out of the 10 tests and only in the speed domain.","['high-performing populations with 15 unique versions for repeated testing', '15 versions of Cognition were administered in three groups of 15-16 subjects (total N =\xa046, mean±SD age 32.5\xa0±\xa07.2\xa0years, range 25-54\xa0years, 23 male']",[],['Cognition test battery'],"[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517710', 'cui_str': '32.5'}, {'cui': 'C4517857', 'cui_str': '7.2'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0086582', 'cui_str': 'Male'}]",[],"[{'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0337088', 'cui_str': 'Electrical battery'}]",,0.0386009,"RESULTS Protracted, non-linear practice effects well beyond the second administration were observed for most of the 10 Cognition tests both in accuracy and speed, but test-retest administration interval significantly affected practice effects only for 3 out of the 10 tests and only in the speed domain.","[{'ForeName': 'Mathias', 'Initials': 'M', 'LastName': 'Basner', 'Affiliation': 'Unit for Experimental Psychiatry, Division of Sleep and Chronobiology, Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania , Philadelphia, PA, USA.'}, {'ForeName': 'Emanuel', 'Initials': 'E', 'LastName': 'Hermosillo', 'Affiliation': 'Unit for Experimental Psychiatry, Division of Sleep and Chronobiology, Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania , Philadelphia, PA, USA.'}, {'ForeName': 'Jad', 'Initials': 'J', 'LastName': 'Nasrini', 'Affiliation': 'Unit for Experimental Psychiatry, Division of Sleep and Chronobiology, Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania , Philadelphia, PA, USA.'}, {'ForeName': 'Salil', 'Initials': 'S', 'LastName': 'Saxena', 'Affiliation': 'Unit for Experimental Psychiatry, Division of Sleep and Chronobiology, Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania , Philadelphia, PA, USA.'}, {'ForeName': 'David F', 'Initials': 'DF', 'LastName': 'Dinges', 'Affiliation': 'Unit for Experimental Psychiatry, Division of Sleep and Chronobiology, Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania , Philadelphia, PA, USA.'}, {'ForeName': 'Tyler M', 'Initials': 'TM', 'LastName': 'Moore', 'Affiliation': 'Brain Behavior Laboratory, Neuropsychiatry Section, Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania , Philadelphia, PA, USA.'}, {'ForeName': 'Ruben C', 'Initials': 'RC', 'LastName': 'Gur', 'Affiliation': 'Brain Behavior Laboratory, Neuropsychiatry Section, Department of Psychiatry, Perelman School of Medicine, University of Pennsylvania , Philadelphia, PA, USA.'}]",Journal of clinical and experimental neuropsychology,['10.1080/13803395.2020.1773765'] 1739,32540134,Event-related desynchronization of alpha and beta band neural oscillations predicts speech and limb motor timing deficits in normal aging.,"Normal aging is associated with decline of motor timing mechanisms implicated in planning and execution of movement. Evidence from previous studies has highlighted the relationship between neural oscillatory activities and motor timing processing in neurotypical younger adults; however, it remains unclear how normal aging affects the underlying neural mechanisms of movement in older populations. In the present study, we recorded EEG activities in two groups of younger and older adults while they performed randomized speech and limb motor reaction time tasks cued by temporally predictable and unpredictable sensory stimuli. Our data showed that older adults were significantly slower than their younger counterparts during speech production and limb movement, especially in response to temporally unpredictable sensory stimuli. This behavioral effect was accompanied by significant desynchronization of alpha (7-12 Hz) and beta (13-25 Hz) band neural oscillatory activities in older compared with younger adults, primarily during the preparatory pre-motor phase of responses for speech production and limb movement. In addition, we found that faster motor reaction times in younger adults were significantly correlated with weaker desynchronization of pre-motor alpha and beta band neural activities irrespective of stimulus timing and response modality. However, the pre-motor components of alpha and beta activities were timing-specific in older adults and were more strongly desynchronized in response to temporally predictable sensory stimuli. These findings highlight the role of alpha and beta band neural oscillations in motor timing processing mechanisms and reflect their functional deficits during the planning phase of speech production and limb movement in normal aging.",2020,"Our data showed that older adults were significantly slower than their younger counterparts during speech production and limb movement, especially in response to temporally unpredictable sensory stimuli.","['Normal Aging', 'neurotypical younger adults', 'two groups of younger and older adults', 'older adults']",['randomized speech and limb motor reaction time tasks cued by temporally predictable and unpredictable sensory stimuli'],['faster motor reaction times'],"[{'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}]","[{'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}]",,0.0320888,"Our data showed that older adults were significantly slower than their younger counterparts during speech production and limb movement, especially in response to temporally unpredictable sensory stimuli.","[{'ForeName': 'Karim', 'Initials': 'K', 'LastName': 'Johari', 'Affiliation': 'Speech Neuroscience Lab, Department of Communication Sciences and Disorders, University of South Carolina, Columbia, SC, United States; Department of Psychology, University of South Carolina, Columbia, SC, United States.'}, {'ForeName': 'Roozbeh', 'Initials': 'R', 'LastName': 'Behroozmand', 'Affiliation': 'Speech Neuroscience Lab, Department of Communication Sciences and Disorders, University of South Carolina, Columbia, SC, United States. Electronic address: r-behroozmand@sc.edu.'}]",Behavioural brain research,['10.1016/j.bbr.2020.112763'] 1740,32540634,"A randomized, double blind, placebo controlled study to evaluate the effects of ashwagandha (Withania somnifera) extract on sleep quality in healthy adults.","OBJECTIVE Non-restorative sleep (NRS) affects 10% people worldwide, leading to poor sleep quality, as well as physical and cognitive fatigue. This is the first human study in which an extract of ashwagandha (Withania somnifera Dunal L.) was evaluated for effects in improving overall sleep quality in subjects with NRS. METHODS In this randomized, double-blind, placebo-controlled trial, 150 healthy subjects scoring high on non-restorative sleep measures were given 120 mg of standardized ashwagandha extract (Shoden®) once daily for six weeks. Subjects were evaluated using the Restorative Sleep Questionnaire-weekly version and World Health Organization Quality of Life-Bref (WHOQOL) scale. Sleep actigraphy was used to measure the onset of sleep latency, sleep efficiency, total sleep time and wake after sleep onset. Safety of the treatment was determined by testing of vitals, hematology, biochemistry and urinalysis. RESULTS A total of 144 subjects completed the study, with no dropouts due to adverse events. A 72% increase in self-reported sleep quality was found for the treatment group, compared with 29% in the placebo group (p < 0.001). Based on activity monitoring data, the treatment group showed significant improvement in sleep efficiency (SE) (p < 0.01), total sleep time (p < 0.001) and sleep latency (p < 0.01) and wake after sleep onset (WASO) (p < 0.05) versus placebo after six weeks. In the ashwagandha group quality of life (QOL) scores showed significant improvement in physical (p < 0.001), psychological (p < 0.001), and environment domains (p < 0.01). CONCLUSIONS Supplementation with the standardized ashwagandha extract for six weeks improved the overall quality of sleep by significantly improving the NRS condition in healthy subjects. No treatment related adverse events were reported in the study. TRIAL REGISTRATION Clinical Trials Registry-India (www.ctri.nic.in). Registration number: CTRI/2017/02/007801.",2020,"Based on activity monitoring data, the treatment group showed significant improvement in sleep efficiency (SE) (p < 0.01), total sleep time (p < 0.001) and sleep latency (p < 0.01) and wake after sleep onset (WASO) (p < 0.05) versus placebo after six weeks.","['subjects with NRS', 'healthy subjects', 'healthy adults', '150 healthy subjects scoring high on non-restorative sleep measures', '144 subjects completed the study, with no dropouts due to adverse events']","['standardized ashwagandha extract (Shoden®', 'ashwagandha (Withania somnifera) extract', 'placebo']","['Sleep actigraphy', 'Restorative Sleep Questionnaire-weekly version and World Health Organization Quality of Life-Bref (WHOQOL) scale', 'total sleep time', 'overall quality of sleep', 'onset of sleep latency, sleep efficiency, total sleep time and wake after sleep onset', 'overall sleep quality', 'sleep latency', 'adverse events', 'quality of life (QOL) scores', 'sleep quality', 'self-reported sleep quality', 'sleep efficiency (SE']","[{'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C4760627', 'cui_str': '144'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]","[{'cui': 'C0613707', 'cui_str': 'Ashwagandha'}, {'cui': 'C1061163', 'cui_str': 'Withania somnifera'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C1171301', 'cui_str': 'Actigraphy'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0332162', 'cui_str': 'Onset of'}, {'cui': 'C4505222', 'cui_str': 'Sleep Onset Latency'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0442696', 'cui_str': 'Waking'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}]",150.0,0.234196,"Based on activity monitoring data, the treatment group showed significant improvement in sleep efficiency (SE) (p < 0.01), total sleep time (p < 0.001) and sleep latency (p < 0.01) and wake after sleep onset (WASO) (p < 0.05) versus placebo after six weeks.","[{'ForeName': 'Abhijit', 'Initials': 'A', 'LastName': 'Deshpande', 'Affiliation': 'International Institute of Sleep Sciences (IISS), NEST Hospital, Second Floor, Behind SBI Naupada Br, Off Gokhale Road, Naupada, Thane, Maharashtra, 400602, India. Electronic address: abhijitd1965@gmail.com.'}, {'ForeName': 'Nushafreen', 'Initials': 'N', 'LastName': 'Irani', 'Affiliation': 'International Institute of Sleep Sciences (IISS), NEST Hospital, Second Floor, Behind SBI Naupada Br, Off Gokhale Road, Naupada, Thane, Maharashtra, 400602, India.'}, {'ForeName': 'Ratna', 'Initials': 'R', 'LastName': 'Balkrishnan', 'Affiliation': 'International Institute of Sleep Sciences (IISS), NEST Hospital, Second Floor, Behind SBI Naupada Br, Off Gokhale Road, Naupada, Thane, Maharashtra, 400602, India.'}, {'ForeName': 'Irin Rosanna', 'Initials': 'IR', 'LastName': 'Benny', 'Affiliation': 'Amala Institute of Medical Sciences, Amala Nagar PO, Thrissur, Kerala, 680555, India.'}]",Sleep medicine,['10.1016/j.sleep.2020.03.012'] 1741,32540685,"Impact of the group intervention ""Accept Voices©"" for the management of auditory hallucinations.","AIM OF THE STUDY The objective of this study was to evaluate the potential impact of a third wave CBT group intervention for the management of auditory hallucinations in patients with schizophrenia. METHOD 38 patients with schizophrenia presenting with auditory hallucinations, followed in mental health services, participated in six sessions of a group based on acceptance and engagement therapy (ACT). The study followed a repeated single case experimental design (type A-B-A) based on the principle of a control phase followed by an intervention phase and a follow-up phase of similar duration. The various measurements were administered during the control phase, at pre-/post-group and six weeks after the last group session. RESULTS The results show a significant decrease in auditory hallucinations, as measured by the PSYRATS scale, during the treatment and follow-up phase, compared to the control phase. In addition, the participants saw significant reductions in depressive and anxious symptomatology (assessed with CDSS and SEAS), and increases in coping and acceptance in regards to voices (assessed using a study scale and VAAS). The level of Malevolence beliefs about voices (measured with BAVQ-R) also decreased significantly. CONCLUSIONS A brief group intervention based acceptance show promise in the reduction of the intensity of auditory hallucinations, depression and anxiety in patients with schizophrenia, while improving their acceptance.",2020,"A brief group intervention based acceptance show promise in the reduction of the intensity of auditory hallucinations, depression and anxiety in patients with schizophrenia, while improving their acceptance.","['patients with schizophrenia', '38 patients with schizophrenia presenting with auditory hallucinations, followed in mental health services, participated in six sessions of a group based on']","['acceptance and engagement therapy (ACT', 'CBT group intervention']","['depressive and anxious symptomatology', 'auditory hallucinations', 'level of Malevolence beliefs about voices (measured with BAVQ-R', 'coping and acceptance', 'intensity of auditory hallucinations, depression and anxiety']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0233762', 'cui_str': 'Auditory hallucinations'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0025355', 'cui_str': 'Mental health service'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0233762', 'cui_str': 'Auditory hallucinations'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]",38.0,0.0263279,"A brief group intervention based acceptance show promise in the reduction of the intensity of auditory hallucinations, depression and anxiety in patients with schizophrenia, while improving their acceptance.","[{'ForeName': 'T', 'Initials': 'T', 'LastName': 'Langlois', 'Affiliation': ""Centre d'Études et de Recherches en Psychopathologie et Psychopathologie de la Santé, Université de Toulouse, UT2J, France. Electronic address: thomas.langlois@univ-tlse2.fr.""}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Sanchez-Rodriguez', 'Affiliation': ""Centre d'Études et de Recherches en Psychopathologie et Psychopathologie de la Santé, Université de Toulouse, UT2J, France.""}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Bourcier', 'Affiliation': 'CHU Toulouse Purpan, Toulouse, France.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Lamy', 'Affiliation': 'Centre médical la Villanelle, Cornebarrieu, France.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Callahan', 'Affiliation': ""Centre d'Études et de Recherches en Psychopathologie et Psychopathologie de la Santé, Université de Toulouse, UT2J, France.""}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Lecomte', 'Affiliation': 'Université de Montréal, Montréal, Canada.'}]",Psychiatry research,['10.1016/j.psychres.2020.113159'] 1742,32540720,Beta-band oscillations as a biomarker of gait recovery in spinal cord injury patients: A quantitative electroencephalography analysis.,"OBJECTIVE The gait recovery in spinal cord injury (SCI) seems to be partially related to the reorganization of cerebral function; however, the neural mechanisms and the respective biomarkers are not well known. This study tested the hypothesis that enhanced beta-band oscillations may be a marker of compensatory neural plasticity during the recovery period in SCI. We tested this hypothesis at baseline in SCI subjects and also in response to cortical stimulation with transcranial direct current stimulation (tDCS) combined with robotic-assisted gait training (RAGT). METHODS In this neurophysiological analysis of a randomized controlled trial, thirty-nine patients with incomplete SCI were included. They received 30 sessions of either active or sham anodal tDCS over the primary motor area for 20 min combined with RAGT. We analyzed the Electroencephalography (EEG) power spectrum and task-related power modulation of EEG oscillations, and their association with gait function indexed by Walk Index for Spinal Cord Injury (WISCI-II). Univariate and multivariate linear/logistic regression analyses were performed to identify the predictors of gait function and recovery. RESULTS Consistent with our hypothesis, we found that in the sensorimotor area: (1) Anodal tDCS combined with RAGT can modulate high-beta EEG oscillations power and enhance gait recovery; (2) higher high-beta EEG oscillations power at baseline can predict baseline gait function; (3) high-beta EEG oscillations power at baseline can predict gait recovery - the higher power at baseline, the better gait recovery; (4) decreases in relative high-beta power and increases in beta power decrease during walking are associated with gait recovery. CONCLUSIONS Enhanced EEG beta oscillations in the sensorimotor area in SCI subjects may be part of a compensatory mechanism to enhance local plasticity. Our results point to the direction that interventions enhancing local plasticity such as tDCS combined with robotic training also lead to an immediate increase in sensorimotor cortex activation, improvement in gait recovery, and subsequent decrease in high-beta power. These findings suggest that beta-band oscillations may be potential biomarkers of gait function and recovery in SCI. SIGNIFICANCE These findings are significant for rehabilitation in SCI patients, and as EEG is a portable, inexpensive, and easy-to-apply system, the clinical translation is feasible to follow better the recovery process and to help to individualize rehabilitation therapies of SCI patients.",2020,This study tested the hypothesis that enhanced beta-band oscillations may be a marker of compensatory neural plasticity during the recovery period in SCI.,"['thirty-nine patients with incomplete SCI were included', 'spinal cord injury patients', 'SCI subjects', 'spinal cord injury (SCI', 'SCI patients']","['active or sham anodal tDCS over the primary motor area for 20\xa0min combined with RAGT', 'transcranial direct current stimulation (tDCS) combined with robotic-assisted gait training (RAGT']","['high-beta EEG oscillations power and enhance gait recovery', 'Electroencephalography (EEG) power spectrum and task-related power modulation of EEG oscillations, and their association with gait function indexed by Walk Index for Spinal Cord Injury (WISCI-II', 'gait recovery', 'sensorimotor cortex activation']","[{'cui': 'C3816447', 'cui_str': '39'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4545488', 'cui_str': 'Incomplete spinal cord injury'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0037929', 'cui_str': 'Spinal cord injury'}]","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C3495441', 'cui_str': 'Precentral Motor Cortex'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0085673', 'cui_str': 'Gait training procedure'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0330390', 'cui_str': 'Beta'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0037929', 'cui_str': 'Spinal cord injury'}, {'cui': 'C3499125', 'cui_str': 'Sensory Motor Cortex'}]",39.0,0.0972225,This study tested the hypothesis that enhanced beta-band oscillations may be a marker of compensatory neural plasticity during the recovery period in SCI.,"[{'ForeName': 'Marcel', 'Initials': 'M', 'LastName': 'Simis', 'Affiliation': 'Physical and Rehabilitation Medicine Institute, General Hospital, Medical School of the University of Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Elif', 'Initials': 'E', 'LastName': 'Uygur-Kucukseymen', 'Affiliation': 'Neuromodulation Center and Center for Clinical Research Learning, Spaulding Rehabilitation Hospital and Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, USA.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Pacheco-Barrios', 'Affiliation': 'Neuromodulation Center and Center for Clinical Research Learning, Spaulding Rehabilitation Hospital and Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, USA; Universidad San Ignacio de Loyola, Vicerrectorado de Investigación, Unidad de Investigación para la Generación y Síntesis de Evidencias en Salud. Lima, Peru.'}, {'ForeName': 'Linamara R', 'Initials': 'LR', 'LastName': 'Battistella', 'Affiliation': 'Physical and Rehabilitation Medicine Institute, General Hospital, Medical School of the University of Sao Paulo, Sao Paulo, Brazil.'}, {'ForeName': 'Felipe', 'Initials': 'F', 'LastName': 'Fregni', 'Affiliation': 'Neuromodulation Center and Center for Clinical Research Learning, Spaulding Rehabilitation Hospital and Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, USA. Electronic address: Fregni.Felipe@mgh.harvard.edu.'}]",Clinical neurophysiology : official journal of the International Federation of Clinical Neurophysiology,['10.1016/j.clinph.2020.04.166'] 1743,32523337,Effectiveness and Economic Evaluation of Hospital-Outreach Pulmonary Rehabilitation for Patients with Chronic Obstructive Pulmonary Disease.,"Objective Hospital-outreach pulmonary rehabilitation (PR) can improve health status and reduce health-care utilization by patients with chronic obstructive pulmonary disease (COPD). However, its long-term effects and costs versus benefits are still not clear. This study was conducted to develop, deliver, and evaluate the effects and monetary savings of a hospital-outreach PR program for patients with COPD. Methods A randomized controlled trial was conducted. Patients with COPD (n=208) were randomly assigned to the hospital-outreach PR program (treatment) or treatment as usual (control). The treatment group received a 3-month intensive intervention, including supervised physical exercise, smoking cessation, self-management education, and psychosocial support, followed by long-term access to a nurse through telephone follow-up and home visits up to 24 months. The control group received routine care, including discharge education and a self-management education brochure. Main outcomes were collected at 3, 6, 12, and 24 -months postrandomization. Primary outcomes included health-care utilization (ie, readmission rates, times, and days, and emergency department visits) and medical costs. Secondary outcomes included lung function (ie, FEV 1 , FEV 1 % predicted, FVC), dyspnea (mMCR), exercise capacity (6MWD), impact on quality of life (CAT), and self-management (CSMS). Results At the end of 24 months, 85 (81.7%) in the treatment group and 89 (85.6%) in the control group had completed the whole program. Compared with the control group, patients in the treatment group had lower readmission rates, times, and days at 6 and 12 months and during 12-24 months. Regarding costs during the 2 years, the program achieved CN¥3,655.94 medical  savings per patient per year, and every ¥1 spent on the program led to ¥3.29 insavings. Patients in the treatment group achieved improvements in FEV 1 , FEV 1 % predicted, exercise capacity, and self-management. It also achieved relief of dyspnea symptoms and improvement in COPD's impact on quality of life. Conclusion The hospital-outreach PR program for patients with COPD achieved reductions in health-care utilization, monetary savings, and improvements in patient health outcomes. The effects of the program were sustained for at least 2 years. Trial Registration This trial was registered at the Chinese Clinical Trial Registry (ChiCTR-TRC-14005108).",2020,"Patients in the treatment group achieved improvements in FEV 1 , FEV 1 % predicted, exercise capacity, and self-management.","['patients with chronic obstructive pulmonary disease (COPD', 'patients with COPD', 'Patients with COPD (n=208', 'Patients with Chronic Obstructive Pulmonary Disease']","['routine care, including discharge education and a self-management education brochure', 'Hospital-Outreach Pulmonary Rehabilitation', '3-month intensive intervention, including supervised physical exercise, smoking cessation, self-management education, and psychosocial support, followed by long-term access to a nurse through telephone follow-up and home visits up to 24 months', 'Hospital-outreach pulmonary rehabilitation (PR', 'hospital-outreach PR program', 'hospital-outreach PR program (treatment) or treatment as usual (control']","['health-care utilization (ie, readmission rates, times, and days, and emergency department visits) and medical costs', 'quality of life', 'health-care utilization, monetary savings, and improvements in patient health outcomes', 'lung function (ie, FEV 1 , FEV 1 % predicted, FVC), dyspnea (mMCR), exercise capacity (6MWD), impact on quality of life (CAT), and self-management (CSMS', 'relief of dyspnea symptoms', 'FEV 1 , FEV 1 % predicted, exercise capacity, and self-management', 'lower readmission rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}]","[{'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0199529', 'cui_str': 'Pulmonary rehabilitation'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C2958078', 'cui_str': 'Psychosocial care'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0178941', 'cui_str': 'Telephone follow-up'}, {'cui': 'C0020043', 'cui_str': 'Home visit'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0030672', 'cui_str': 'Health Care Utilization'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0586082', 'cui_str': 'Emergency department patient visit'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0036245', 'cui_str': 'Savings'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C3714541', 'cui_str': 'Forced vital capacity'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C4521841', 'cui_str': 'US Military enlisted E9'}, {'cui': 'C0564405', 'cui_str': 'Feeling relief'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205251', 'cui_str': 'Low'}]",208.0,0.0443092,"Patients in the treatment group achieved improvements in FEV 1 , FEV 1 % predicted, exercise capacity, and self-management.","[{'ForeName': 'Aidi', 'Initials': 'A', 'LastName': 'Zhang', 'Affiliation': ""Nursing Department, Third Xiangya Hospital of Central South University, Changsha 410013, People's Republic of China.""}, {'ForeName': 'Lianhong', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': ""The First Affiliated Hospital of Zunyi Medical University, Zunyi 563003, People's Republic of China.""}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Long', 'Affiliation': ""Nursing Department, Third Xiangya Hospital of Central South University, Changsha 410013, People's Republic of China.""}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Yan', 'Affiliation': ""Nursing Department, Third Xiangya Hospital of Central South University, Changsha 410013, People's Republic of China.""}, {'ForeName': 'Chun', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': ""Respiratory Department, Third Xiangya Hospital of Central South University, Changsha 410013, People's Republic of China.""}, {'ForeName': 'Sucui', 'Initials': 'S', 'LastName': 'Zhu', 'Affiliation': ""Nursing Department, Third Xiangya Hospital of Central South University, Changsha 410013, People's Republic of China.""}, {'ForeName': 'Xiaowan', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': ""Center for Health Policy and Management, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100730, People's Republic of China.""}]",International journal of chronic obstructive pulmonary disease,['10.2147/COPD.S239841'] 1744,32525235,Continuation Sessions of Mindfulness-Based Cognitive Therapy (MBCT-C) vs. Treatment as Usual in Late-Life Depression and Anxiety: An Open-Label Extension Study.,"OBJECTIVES Mindfulness-based cognitive therapy (MBCT) is a novel treatment for depression. Our published randomized controlled trial shows that MBCT improves symptoms of late-life depression (LLD) and anxiety (LLA). We now examine whether continuation sessions of MBCT (MBCT-C) can prevent LLD/LLA symptom recurrence. METHODS/DESIGN Following an 8-week MBCT intervention, we compared patients who attended open-label weekly 1-hour MBCT-C for another 26 weeks (n = 10) vs those who did not (n = 17) for change in depressive and anxiety symptoms. RESULTS While there were no significant differences between groups on depressive or anxiety symptom severities between 8- and 34- weeks (Cohen's d = 0.045), we observed a small clinical effect of MBCT-C on symptoms of anxiety (d = 0.29). CONCLUSIONS These preliminary results suggest that MBCT-C may be somewhat beneficial for symptoms of LLA, but not for LLD. Healthcare providers should consider what is clinically feasible before investing time and resources into MBCT-C in older adults with depression and/or anxiety.",2020,"While there were no significant differences between groups on depressive or anxiety symptom severities between 8- and 34- weeks (Cohen's d = 0.045), we observed a small clinical effect of MBCT-C on symptoms of anxiety (d = 0.29). ","['Late-Life Depression and Anxiety', 'Older Adults', 'older adults with depression and/or anxiety']","['MBCT', 'MBCT intervention', 'Mindfulness-Based Cognitive Therapy (MBCT-C', 'MBCT (MBCT-C', 'Mindfulness-Based Cognitive Therapy (MBCT']","['depressive or anxiety symptom severities', 'symptoms of anxiety', 'symptoms of late-life depression (LLD) and anxiety (LLA']","[{'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]",,0.0552697,"While there were no significant differences between groups on depressive or anxiety symptom severities between 8- and 34- weeks (Cohen's d = 0.045), we observed a small clinical effect of MBCT-C on symptoms of anxiety (d = 0.29). ","[{'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Dikaios', 'Affiliation': 'McGill Meditation and Mind-Body Medicine Research Clinic (MMMM-RC) and GeriPARTy Research Group, Jewish General Hospital, Montreal, Canada.'}, {'ForeName': 'Sophia', 'Initials': 'S', 'LastName': 'Escobar', 'Affiliation': 'McGill Meditation and Mind-Body Medicine Research Clinic (MMMM-RC) and GeriPARTy Research Group, Jewish General Hospital, Montreal, Canada.'}, {'ForeName': 'Marouane', 'Initials': 'M', 'LastName': 'Nassim', 'Affiliation': 'McGill Meditation and Mind-Body Medicine Research Clinic (MMMM-RC) and GeriPARTy Research Group, Jewish General Hospital, Montreal, Canada.'}, {'ForeName': 'Chien-Lin', 'Initials': 'CL', 'LastName': 'Su', 'Affiliation': 'Department of Epidemiology, Biostatistics and Occupational Health, McGill University, Quebec, Canada.'}, {'ForeName': 'Susana G', 'Initials': 'SG', 'LastName': 'Torres-Platas', 'Affiliation': 'McGill Meditation and Mind-Body Medicine Research Clinic (MMMM-RC) and GeriPARTy Research Group, Jewish General Hospital, Montreal, Canada.'}, {'ForeName': 'Soham', 'Initials': 'S', 'LastName': 'Rej', 'Affiliation': 'McGill Meditation and Mind-Body Medicine Research Clinic (MMMM-RC) and GeriPARTy Research Group, Jewish General Hospital, Montreal, Canada.'}]",International journal of geriatric psychiatry,['10.1002/gps.5360'] 1745,32529206,Effects of oily fish intake on cognitive and socioemotional function in healthy 8-9-year-old children: the FiSK Junior randomized trial.,"BACKGROUND Long-chain n-3 PUFAs (n-3 LCPUFAs) accrete in the brain during childhood and affect brain development. Randomized trials in children show inconsistent effects of n-3 LCPUFAs on cognitive and socioemotional function, and few have investigated effects of fish per se. OBJECTIVES We aimed to investigate the effects of oily fish consumption on overall and domain-specific cognitive and socioemotional scores and explore sex differences. METHODS Healthy 8-9-y-old children (n = 199) were randomly allocated to receive ∼300 g/wk oily fish or poultry (control) for 12 ± 2 wk. At baseline and endpoint, we assessed attention, processing speed, executive functions, memory, emotions, and behavior with a large battery of tests and questionnaires and analyzed erythrocyte fatty acid composition. RESULTS One hundred and ninety-seven (99%) children completed the trial. Children in the fish group consumed 375 (25th-75th percentile: 325-426) g/wk oily fish resulting in 2.3 (95% CI: 1.9, 2.6) fatty acid percentage points higher erythrocyte n-3 LCPUFA than in the poultry group. The overall cognitive performance score tended to improve by 0.17 (95% CI: -0.01, 0.35) points in children who received fish compared with poultry, supported by n-3 LCPUFA dose dependency. This was driven mainly by fewer errors [-1.9 (95% CI: -3.4, -0.3)] in an attention task and improved cognitive flexibility measured as faster reaction time [-51 ms (95% CI: -94, -7 ms)] in a complex relative to a simple task (""mixing cost""). The fish intervention furthermore reduced parent-rated Strength and Difficulties Questionnaire total difficulties by -0.89 (95% CI: -1.60, -0.18) points mainly due to a -0.63 (95% CI: -1.11, -0.16) points reduction in internalizing problems that was reflected in tendency to a decrease in the overall socioemotional problems score of -0.13 (95% CI: -0.26, 0.01) points. The overall effects were similar in boys and girls. CONCLUSIONS Oily fish dose-dependently improved cognitive function, especially attention and cognitive flexibility, and reduced socioemotional problems. The results support the importance of n-3 LCPUFAs for optimal brain function and fish intake recommendations in children.The trial was registered at www.clinicaltrials.gov as NCT02809508.",2020,The fish intervention furthermore reduced parent-rated Strength and Difficulties Questionnaire total difficulties by -0.89,"['One hundred and ninety-seven (99%) children completed the trial', 'Healthy 8-9-y-old children (n\xa0=\xa0199', 'healthy 8-9-year-old children', 'children']","['n-3 LCPUFA', 'n-3 LCPUFAs', 'oily fish intake', 'oily fish consumption', '∼300 g/wk oily fish or poultry (control']","['overall and domain-specific cognitive and socioemotional scores and explore sex differences', 'overall effects', 'attention task and improved cognitive flexibility', 'reaction time ', 'cognitive function, especially attention and cognitive flexibility, and reduced socioemotional problems', 'overall cognitive performance score', 'cognitive and socioemotional function', 'attention, processing speed, executive functions, memory, emotions, and behavior with a large battery of tests and questionnaires and analyzed erythrocyte fatty acid composition', 'parent-rated Strength and Difficulties Questionnaire total difficulties', 'overall socioemotional problems score']","[{'cui': 'C4517622', 'cui_str': '190'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0556218', 'cui_str': 'Fatty fish intake'}, {'cui': 'C0453017', 'cui_str': 'Fatty fish'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0556978', 'cui_str': 'g/week'}, {'cui': 'C0032850', 'cui_str': 'Fowls, Domestic'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0036866', 'cui_str': 'Sex Differences'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0582591', 'cui_str': 'Processing speed'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0337088', 'cui_str': 'Electrical battery'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0014772', 'cui_str': 'Red blood cell count'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C3472494', 'cui_str': 'Strengths and difficulties questionnaire'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}]",199.0,0.37571,The fish intervention furthermore reduced parent-rated Strength and Difficulties Questionnaire total difficulties by -0.89,"[{'ForeName': 'Marie N', 'Initials': 'MN', 'LastName': 'Teisen', 'Affiliation': 'Department of Nutrition, Exercise, and Sports, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Stine', 'Initials': 'S', 'LastName': 'Vuholm', 'Affiliation': 'Department of Nutrition, Exercise, and Sports, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Janni', 'Initials': 'J', 'LastName': 'Niclasen', 'Affiliation': 'Department of Psychology, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Juan J', 'Initials': 'JJ', 'LastName': 'Aristizabal-Henao', 'Affiliation': 'Department of Kinesiology, University of Waterloo, Waterloo, Ontario, Canada.'}, {'ForeName': 'Ken D', 'Initials': 'KD', 'LastName': 'Stark', 'Affiliation': 'Department of Kinesiology, University of Waterloo, Waterloo, Ontario, Canada.'}, {'ForeName': 'Svend S', 'Initials': 'SS', 'LastName': 'Geertsen', 'Affiliation': 'Department of Nutrition, Exercise, and Sports, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Camilla T', 'Initials': 'CT', 'LastName': 'Damsgaard', 'Affiliation': 'Department of Nutrition, Exercise, and Sports, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Lotte', 'Initials': 'L', 'LastName': 'Lauritzen', 'Affiliation': 'Department of Nutrition, Exercise, and Sports, University of Copenhagen, Copenhagen, Denmark.'}]",The American journal of clinical nutrition,['10.1093/ajcn/nqaa050'] 1746,32530334,Autologous plasma gel injection combined with scar subcision is a successful technique for atrophic post-acne scars: a split-face study.,"Background: Different therapeutic options can be used for post-acne scarring. Scar subcision alone or in combination with other treatments have been used by many dermatologists to treat post-acne scarring. Objectives: We thought to study and compare the efficacy and safety of scar subcision combined with platelet gel injection versus scar subcision combined with PRP injection for atrophic post-acne scarring. Patients and methods: Scar subcision was done 1st on both sides of the face. Plasma gel injection was done on the right side and PRP injection was done on the left side. The sessions were done monthly for 4 months followed by a 6-month follow-up period. Evaluation of the results and any complications were recorded. Results: There was a significant improvement ( p  = .035) of the scars on the subcision-gel-side at one month following the 1st treatment session. However, along with the following sessions, there were no significant differences between both sides. Finally, at the follow-up visit after 6 months following the end of the treatment course there was a significant difference between the two sides of the face in favor of the subcision-gel-side. Conclusions: Subcision combined with autologous plasma gel injection is a successful technique for atrophic post-acne scars.",2020,There was a significant improvement (p = 0.035) of the scars on the subcision-gel-side at one month following the 1 st treatment session.,"['atrophic post-acne scars', 'atrophic post-acne scarring']","['Autologous plasma gel injection combined with scar subcision', 'Subcision combined with autologous plasma gel injection', 'scar subcision combined with platelet gel injection versus scar subcision combined with PRP injection']","['efficacy and safety', 'Scar subcision']","[{'cui': 'C0333641', 'cui_str': 'Atrophy'}, {'cui': 'C0423783', 'cui_str': 'Acne scar'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0001144', 'cui_str': 'Acne vulgaris'}]","[{'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0008767', 'cui_str': 'Scarring'}, {'cui': 'C4761112', 'cui_str': 'Subcision'}, {'cui': 'C0005821', 'cui_str': 'thrombocytes'}, {'cui': 'C0032027', 'cui_str': 'Pityriasis rubra pilaris'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0008767', 'cui_str': 'Scarring'}, {'cui': 'C4761112', 'cui_str': 'Subcision'}]",,0.0216317,There was a significant improvement (p = 0.035) of the scars on the subcision-gel-side at one month following the 1 st treatment session.,"[{'ForeName': 'Amany', 'Initials': 'A', 'LastName': 'Nassar', 'Affiliation': 'Dermatology, Venereology & Andrology Department, Faculty of Medicine, Zagazig University, Zagazig, Egypt.'}, {'ForeName': 'Walaa', 'Initials': 'W', 'LastName': 'El-Shaarawy', 'Affiliation': 'Dermatology, Venereology & Andrology Department, Faculty of Medicine, Zagazig University, Zagazig, Egypt.'}, {'ForeName': 'Eman', 'Initials': 'E', 'LastName': 'Salah', 'Affiliation': 'Dermatology, Venereology & Andrology Department, Faculty of Medicine, Zagazig University, Zagazig, Egypt.'}]",The Journal of dermatological treatment,['10.1080/09546634.2020.1782322'] 1747,32526634,"Randomised phase II study of panitumumab plus irinotecan versus cetuximab plus irinotecan in patients with KRAS wild-type metastatic colorectal cancer refractory to fluoropyrimidine, irinotecan and oxaliplatin (WJOG 6510G).","BACKGROUND Cetuximab has been shown to be clinically active when given in combination with irinotecan in patients with irinotecan-refractory metastatic colorectal cancer (mCRC). However, it has remained unclear whether panitumumab is effective when combined with irinotecan. We compared efficacies of both regimens in this randomised phase II study. PATIENTS AND METHODS Patients with wild-type KRAS exon 2 mCRC previously treated with fluorouracil-, oxaliplatin- and irinotecan-based chemotherapies were randomised (1:1) to either panitumumab plus irinotecan (panitumumab arm) or cetuximab plus irinotecan (cetuximab arm). The primary end-point was progression-free survival (PFS). The planned sample size was 120, expecting a hazard ratio (HR) of 1.0 with non-inferiority margin of 1.3 (one-sided alpha error 0.2 and power 0.7). Major secondary end-points were overall survival (OS), response rate and safety. RESULTS From December 2011 to September 2014, 121 patients were enrolled, and 61 and 59 patients were randomised to the panitumumab and cetuximab arms, respectively (1 patient excluded). Most patients (97%) had received prior chemotherapies containing bevacizumab. The median PFS was 5.42 months in the panitumumab arm and 4.27 months in the cetuximab arm (HR = 0.64, 95% confidence interval [CI] = 0.44-0.94, P < 0.001 for non-inferiority, P = 0.058 for superiority), and median OS was 14.85 and 11.53 months (HR = 0.66, 95% CI = 0.44-1.00, P = 0.050 for superiority), respectively. The incidence of grade 3 or 4 hypomagnesaemia was higher in the panitumumab arm than that in the cetuximab arm (17% vs. 7%). CONCLUSION Panitumumab may be non-inferior to cetuximab in combination with irinotecan in survival of patients with irinotecan-refractory mCRC.",2020,"CONCLUSION Panitumumab may be non-inferior to cetuximab in combination with irinotecan in survival of patients with irinotecan-refractory mCRC.","['patients with KRAS wild-type metastatic colorectal cancer refractory to', 'patients with irinotecan-refractory metastatic colorectal cancer (mCRC', 'From December 2011 to September 2014', 'patients with irinotecan-refractory mCRC', '121 patients were enrolled, and 61 and 59 patients', 'Patients with wild-type KRAS exon 2 mCRC previously treated with']","['panitumumab plus irinotecan versus cetuximab plus irinotecan', 'fluoropyrimidine, irinotecan\xa0and oxaliplatin (WJOG 6510G', 'panitumumab', 'panitumumab and cetuximab', 'panitumumab plus irinotecan (panitumumab arm) or cetuximab plus irinotecan (cetuximab arm', 'irinotecan', 'bevacizumab', 'fluorouracil-, oxaliplatin-\xa0and irinotecan-based chemotherapies']","['median OS', 'incidence of grade 3 or 4 hypomagnesaemia', 'overall survival (OS), response rate\xa0and safety', 'progression-free survival (PFS', 'median PFS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0445392', 'cui_str': 'Wild'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C4721579', 'cui_str': 'Secondary malignant neoplasm of colon and/or rectum'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0123931', 'cui_str': 'irinotecan'}, {'cui': 'C0015295', 'cui_str': 'Exons'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0879427', 'cui_str': 'panitumumab'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0123931', 'cui_str': 'irinotecan'}, {'cui': 'C0995188', 'cui_str': 'cetuximab'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0151723', 'cui_str': 'Hypomagnesemia'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",121.0,0.220477,"CONCLUSION Panitumumab may be non-inferior to cetuximab in combination with irinotecan in survival of patients with irinotecan-refractory mCRC.","[{'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Sakai', 'Affiliation': 'Department of Frontier Science for Cancer and Chemotherapy, Osaka University Graduate School of Medicine, Suita, Japan. Electronic address: dsakai@cfs.med.osaka-u.ac.jp.'}, {'ForeName': 'Hiroya', 'Initials': 'H', 'LastName': 'Taniguchi', 'Affiliation': 'Department of Clinical Oncology, Aichi Cancer Center Hospital, Nagoya, Japan.'}, {'ForeName': 'Naotoshi', 'Initials': 'N', 'LastName': 'Sugimoto', 'Affiliation': 'Department of Medical Oncology, Osaka International Cancer Institute, Osaka, Japan.'}, {'ForeName': 'Takao', 'Initials': 'T', 'LastName': 'Tamura', 'Affiliation': 'Department of Medical Oncology, Kindai University Faculty of Medicine, Osaka-Sayama, Japan.'}, {'ForeName': 'Tomohiro', 'Initials': 'T', 'LastName': 'Nishina', 'Affiliation': 'Department of Gastrointestinal Medical Oncology, National Hospital Organization Shikoku Cancer Center, Matsuyama, Japan.'}, {'ForeName': 'Hiroki', 'Initials': 'H', 'LastName': 'Hara', 'Affiliation': 'Department of Gastroenterology, Saitama Cancer Center, Saitama, Japan.'}, {'ForeName': 'Taito', 'Initials': 'T', 'LastName': 'Esaki', 'Affiliation': 'Department of Gastrointestinal and Medical Oncology, National Hospital Organization Kyushu Cancer Center, Fukuoka, Japan.'}, {'ForeName': 'Tadamichi', 'Initials': 'T', 'LastName': 'Denda', 'Affiliation': 'Division of Gastroenterology, Chiba Cancer Center, Chiba, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Sakamoto', 'Affiliation': 'Department of Gastroetererological Oncology, Hyogo Cancer Center, Akashi, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Okuda', 'Affiliation': 'Department of Medical Oncology, Keiyukai Sapporo Hospital, Sapporo, Japan.'}, {'ForeName': 'Taroh', 'Initials': 'T', 'LastName': 'Satoh', 'Affiliation': 'Department of Frontier Science for Cancer and Chemotherapy, Osaka University Graduate School of Medicine, Suita, Japan.'}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Tsushima', 'Affiliation': 'Division of Gastrointestinal Oncology, Shizuoka Cancer Center, Shizuoka, Japan.'}, {'ForeName': 'Akitaka', 'Initials': 'A', 'LastName': 'Makiyama', 'Affiliation': 'Department of Hematology/Oncology, Japan Community Healthcare Organization Kyushu Hospital, Fukuoka, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Tsuda', 'Affiliation': 'Department of Clinical Oncology, St. Marianna University School of Medicine, Kawasaki, Japan.'}, {'ForeName': 'Ayumu', 'Initials': 'A', 'LastName': 'Hosokawa', 'Affiliation': 'Department of Gastroenterology and Hematology, Faculty of Medicine, University of Toyama, Toyama, Japan.'}, {'ForeName': 'Hidekazu', 'Initials': 'H', 'LastName': 'Kuramochi', 'Affiliation': ""Department of Chemotherapy, Tokyo Women's Medical University, Yachiyo Medical Center, Yachiyo, Japan.""}, {'ForeName': 'Shinya', 'Initials': 'S', 'LastName': 'Tokunaga', 'Affiliation': 'Department of Medical Oncology, Osaka City General Hospital, Osaka, Japan.'}, {'ForeName': 'Toshikazu', 'Initials': 'T', 'LastName': 'Moriwaki', 'Affiliation': 'Division of Gastroenterology, Faculty of Medicine, University of Tsukuba, Tsukuba, Japan.'}, {'ForeName': 'Hisateru', 'Initials': 'H', 'LastName': 'Yasui', 'Affiliation': 'Department of Medical Oncology, Kobe City Medical Center General Hospital, Kobe, Japan.'}, {'ForeName': 'Hiroyasu', 'Initials': 'H', 'LastName': 'Ishida', 'Affiliation': 'Department of Gastroenterology, National Hospital Organization Mito Medical Center, Mito, Japan.'}, {'ForeName': 'Akihito', 'Initials': 'A', 'LastName': 'Tsuji', 'Affiliation': 'Department of Clinical Oncology, Kagawa University Faculty of Medicine, Kagawa, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Otsu', 'Affiliation': 'Department of Medical Oncology and Hematology, Oita University Faculty of Medicine, Oita, Japan.'}, {'ForeName': 'Hozumi', 'Initials': 'H', 'LastName': 'Shimokawa', 'Affiliation': 'Department of Medical Oncology, Clinical Research Institute, National Hospital Organization Kyushu Medical Center, Japan.'}, {'ForeName': 'Eishi', 'Initials': 'E', 'LastName': 'Baba', 'Affiliation': 'Department of Oncology and Social Medicine, Graduate School of Medical Sciences, Kyushu University, Japan.'}, {'ForeName': 'Mikio', 'Initials': 'M', 'LastName': 'Sato', 'Affiliation': 'Department of Gastroenterology and Hepatology, Ryugasaki Saiseikai Hospital, Ryugasaki, Japan.'}, {'ForeName': 'Shigemi', 'Initials': 'S', 'LastName': 'Matsumoto', 'Affiliation': 'Department of Medical Oncology, Kyoto University Hospital, Kyoto, Japan.'}, {'ForeName': 'Yukinori', 'Initials': 'Y', 'LastName': 'Ozaki', 'Affiliation': 'Department of Medical Oncology, Toranomon Hospital, Tokyo, Japan.'}, {'ForeName': 'Katsunori', 'Initials': 'K', 'LastName': 'Shinozaki', 'Affiliation': 'Division of Clinical Oncology, Hiroshima Prefectural Hospital, Hiroshima, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Tamagawa', 'Affiliation': 'Department of Surgery, Osaka General Medical Center, Osaka, Japan.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Goto', 'Affiliation': 'Cancer Chemotherapy Center, Osaka Medical College, Osaka, Japan.'}, {'ForeName': 'Shigenori', 'Initials': 'S', 'LastName': 'Kadowaki', 'Affiliation': 'Department of Clinical Oncology, Aichi Cancer Center Hospital, Nagoya, Japan.'}, {'ForeName': 'Hirofumi', 'Initials': 'H', 'LastName': 'Fujii', 'Affiliation': 'Department of Clinical Oncology, Jichi Medical University Hospital, Tochigi, Japan.'}, {'ForeName': 'Yasuhiro', 'Initials': 'Y', 'LastName': 'Koh', 'Affiliation': 'Internal Medicine III, Wakayama Medical University, Wakayama, Japan.'}, {'ForeName': 'Kentaro', 'Initials': 'K', 'LastName': 'Yamazaki', 'Affiliation': 'Division of Gastrointestinal Oncology, Shizuoka Cancer Center, Shizuoka, Japan.'}, {'ForeName': 'Shuichi', 'Initials': 'S', 'LastName': 'Hironaka', 'Affiliation': 'Department of Medical Oncology and Hematology, Oita University Faculty of Medicine, Oita, Japan.'}, {'ForeName': 'Junji', 'Initials': 'J', 'LastName': 'Kishimoto', 'Affiliation': 'Center for Clinical and Translational Research, Kyushu University Hospital, Japan.'}, {'ForeName': 'Narikazu', 'Initials': 'N', 'LastName': 'Boku', 'Affiliation': 'Division of Gastrointestinal Medical Oncology, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Ichinosuke', 'Initials': 'I', 'LastName': 'Hyodo', 'Affiliation': 'Division of Gastroenterology, Faculty of Medicine, University of Tsukuba, Tsukuba, Japan.'}, {'ForeName': 'Kei', 'Initials': 'K', 'LastName': 'Muro', 'Affiliation': 'Department of Clinical Oncology, Aichi Cancer Center Hospital, Nagoya, Japan.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2020.04.014'] 1748,32526669,A CT-based deep learning model for predicting the nuclear grade of clear cell renal cell carcinoma.,"PURPOSE To investigate the effects of different methodologies on the performance of deep learning (DL) model for differentiating high- from low-grade clear cell renal cell carcinoma (ccRCC). METHOD Patients with pathologically proven ccRCC diagnosed between October 2009 and March 2019 were assigned to training or internal test dataset, and external test dataset was acquired from The Cancer Genome Atlas-Kidney Renal Clear Cell Carcinoma (TCGA-KIRC) database. The effects of different methodologies on the performance of DL-model, including image cropping (IC), setting the attention level, selecting model complexity (MC), and applying transfer learning (TL), were compared using repeated measures analysis of variance (ANOVA) and receiver operating characteristic (ROC) curve analysis. The performance of DL-model was evaluated through accuracy and ROC analyses with internal and external tests. RESULTS In this retrospective study, patients (n = 390) from one hospital were randomly assigned to training (n = 370) or internal test dataset (n = 20), and the other 20 patients from TCGA-KIRC database were assigned to external test dataset. IC, the attention level, MC, and TL had major effects on the performance of the DL-model. The DL-model based on the cropping of an image less than three times the tumor diameter, without attention, a simple model and the application of TL achieved the best performance in internal (ACC = 73.7 ± 11.6%, AUC = 0.82 ± 0.11) and external (ACC = 77.9 ± 6.2%, AUC = 0.81 ± 0.04) tests. CONCLUSIONS CT-based DL model can be conveniently applied for grading ccRCC with simple IC in routine clinical practice.",2020,"IC, the attention level, MC, and TL had major effects on the performance of the DL-model.","['Patients with pathologically proven ccRCC diagnosed between October 2009 and March 2019', 'differentiating high- from low-grade clear cell renal cell carcinoma (ccRCC', 'patients (n\u202f=\u202f390) from one hospital were randomly assigned to training (n\u202f=\u202f370) or internal test dataset (n\u202f=\u202f20), and the other 20 patients from TCGA-KIRC database']",['CT-based deep learning model'],"['performance of DL-model, including image cropping (IC), setting the attention level, selecting model complexity (MC), and applying transfer learning (TL']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0456369', 'cui_str': 'Proven'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0205615', 'cui_str': 'Well differentiated'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1962916', 'cui_str': 'Low grade (lymphoma)'}, {'cui': 'C0279702', 'cui_str': 'Clear cell carcinoma of kidney'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C4517743', 'cui_str': '370'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0150098', 'cui_str': 'Data Set'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0017428', 'cui_str': 'Genome'}, {'cui': 'C0004170', 'cui_str': 'Bone structure of atlas'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C4704761', 'cui_str': 'Hierarchical Learning'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}]","[{'cui': 'C4704761', 'cui_str': 'Hierarchical Learning'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C4760635', 'cui_str': 'Transfer Learning'}]",,0.0253668,"IC, the attention level, MC, and TL had major effects on the performance of the DL-model.","[{'ForeName': 'Fan', 'Initials': 'F', 'LastName': 'Lin', 'Affiliation': ""Department of Radiology, The First Affiliated Hospital of Shenzhen University, Health Science Center, Shenzhen Second People's Hospital, 3002 SunGangXi Road, Shenzhen, 518035, China.""}, {'ForeName': 'Changyi', 'Initials': 'C', 'LastName': 'Ma', 'Affiliation': 'Department of Radiology, Jiangmen Central Hospital, Affiliated Jiangmen Hospital of Guangdong Medical University, Affiliated Jiangmen Hospital of SUN YAT-SEN University, 23 Beijie Haibang Street, Jiangmen, 529030, China.'}, {'ForeName': 'Jinpeng', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': 'Department of Radiology, Jiangmen Central Hospital, Affiliated Jiangmen Hospital of Guangdong Medical University, Affiliated Jiangmen Hospital of SUN YAT-SEN University, 23 Beijie Haibang Street, Jiangmen, 529030, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Lei', 'Affiliation': ""Department of Radiology, The First Affiliated Hospital of Shenzhen University, Health Science Center, Shenzhen Second People's Hospital, 3002 SunGangXi Road, Shenzhen, 518035, China.""}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'Department of Pathology, Jiangmen Central Hospital, Affiliated Jiangmen Hospital of SUN YAT-SEN University, 23 Beijie Haibang Street, Jiangmen, 529030, China.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Lan', 'Affiliation': 'Department of Radiology, Jiangmen Central Hospital, Affiliated Jiangmen Hospital of Guangdong Medical University, Affiliated Jiangmen Hospital of SUN YAT-SEN University, 23 Beijie Haibang Street, Jiangmen, 529030, China.'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Sun', 'Affiliation': 'Department of Urology, Jiangmen Central Hospital, Affiliated Jiangmen Hospital of SUN YAT-SEN University, 23 Beijie Haibang Street, Jiangmen, 529030, China.'}, {'ForeName': 'Wansheng', 'Initials': 'W', 'LastName': 'Long', 'Affiliation': 'Department of Radiology, Jiangmen Central Hospital, Affiliated Jiangmen Hospital of Guangdong Medical University, Affiliated Jiangmen Hospital of SUN YAT-SEN University, 23 Beijie Haibang Street, Jiangmen, 529030, China.'}, {'ForeName': 'Enming', 'Initials': 'E', 'LastName': 'Cui', 'Affiliation': 'Department of Radiology, Jiangmen Central Hospital, Affiliated Jiangmen Hospital of Guangdong Medical University, Affiliated Jiangmen Hospital of SUN YAT-SEN University, 23 Beijie Haibang Street, Jiangmen, 529030, China. Electronic address: cem2008@163.com.'}]",European journal of radiology,['10.1016/j.ejrad.2020.109079'] 1749,32528046,Author Correction: Vitamin D Supplementation in Overweight/obese Asian Indian Women with Prediabetes Reduces Glycemic Measures and Truncal Subcutaneous Fat: A 78 Weeks Randomized Placebo-Controlled Trial (PREVENT-WIN Trial).,An amendment to this paper has been published and can be accessed via a link at the top of the paper.,2020,An amendment to this paper has been published and can be accessed via a link at the top of the paper.,['Overweight/obese Asian Indian Women with Prediabetes Reduces Glycemic Measures and Truncal Subcutaneous Fat'],"['Placebo', 'Author Correction: Vitamin D Supplementation']",[],"[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C1524069', 'cui_str': 'Indian'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0271650', 'cui_str': 'Impaired glucose tolerance'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0222331', 'cui_str': 'Subcutaneous fatty tissue'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3812881', 'cui_str': 'Author'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}]",[],,0.30447,An amendment to this paper has been published and can be accessed via a link at the top of the paper.,"[{'ForeName': 'Surya Prakash', 'Initials': 'SP', 'LastName': 'Bhatt', 'Affiliation': 'Diabetes Foundation (India), Safdarjung Development Area, New Delhi, 110016, India.'}, {'ForeName': 'Anoop', 'Initials': 'A', 'LastName': 'Misra', 'Affiliation': 'Diabetes Foundation (India), Safdarjung Development Area, New Delhi, 110016, India. anoopmisra@gmail.com.'}, {'ForeName': 'Ravindra Mohan', 'Initials': 'RM', 'LastName': 'Pandey', 'Affiliation': 'Biostatistics, All India Institute of Medical Sciences, Ansari Nagar, New Delhi, 110029, India.'}, {'ForeName': 'Ashish Datt', 'Initials': 'AD', 'LastName': 'Upadhyay', 'Affiliation': 'Biostatistics, All India Institute of Medical Sciences, Ansari Nagar, New Delhi, 110029, India.'}, {'ForeName': 'Seema', 'Initials': 'S', 'LastName': 'Gulati', 'Affiliation': 'Diabetes Foundation (India), Safdarjung Development Area, New Delhi, 110016, India.'}, {'ForeName': 'Namrata', 'Initials': 'N', 'LastName': 'Singh', 'Affiliation': 'Diabetes Foundation (India), Safdarjung Development Area, New Delhi, 110016, India.'}]",Scientific reports,['10.1038/s41598-020-67064-9'] 1750,32533723,Preoperative high-dose Steroids in Total Knee and Hip Arthroplasty - Protocols for three randomized controlled trials.,"BACKGROUND Patients undergoing total knee arthroplasty (TKA)/ total hip arthroplasty (THA) still experience moderate-severe postoperative pain despite optimized pain management regimes. The patients already on opioid treatment and pain catastrophizers (PCs) have a higher risk of postoperative pain. The use of preoperative intravenous high-dose glucocorticoids decreases postoperative pain after TKA and THA, but optimal dose is yet to be found, and the effect on subpopulations at high pain risk is unknown. AIM To investigate the effect of a higher than previously used dose of glucocorticoids (dexamethasone (DXM)), administered intravenously before surgery, as part of standardized fast-track regimen, on postoperative pain in TKA/THA subgroups. METHOD Three separate randomized, double-blinded, controlled trials were planned to compare a new higher dose DXM (1 mg/kg) to the earlier used high-dose DXM (0.3 mg/kg). Study 1: predicted Low Pain TKA; study 2: predicted High Pain Responder (HPR) TKA; study 3: predicted HPR THA. Predicted HPR groups consist of either PCs with PCS-score of ≥ 21 and/or history of ongoing opioid-treatment of 30 mg/day of morphine or equivalents > 30 days. In total, 408 patients were planned for inclusion (160 Low Pain TKA, 88 HPR TKA, 160 HPR THA). PRIMARY OUTCOME Pain upon ambulation in a 5-meter walk test 24 hours after surgery. Secondary outcomes include use of analgesics, rescue-opioids, antiemetics, cumulated pain, CRP, OR-SDS, QoR-15, quality of sleep, length of stay (LOS), reasons for hospitalization, readmission, morbidity, and mortality. Patients completed follow-up on day 90. Recruiting commenced February 2019 and is expected to finish in September 2020.",2020,"Secondary outcomes include use of analgesics, rescue-opioids, antiemetics, cumulated pain, CRP, OR-SDS, QoR-15, quality of sleep, length of stay (LOS), reasons for hospitalization, readmission, morbidity and mortality.","['408 patients in total are planned for inclusion (160 Low Pain TKA, 88 HPR TKA, 160 HPR THA', 'Total Knee and Hip Arthroplasty - Protocols', 'Patients undergoing total knee arthroplasty (TKA) / total hip arthroplasty (THA) still experience moderate-severe postoperative pain despite optimized pain management regimes']","['glucocorticoids (dexamethasone (DXM', 'glucocorticoids', 'DXM', 'Preoperative high-dose Steroids', 'morphine']","['Pain upon ambulation in a 5-meter walk test 24 hours after surgery', 'use of analgesics, rescue-opioids, antiemetics, cumulated pain, CRP, OR-SDS, QoR-15, quality of sleep, length of stay (LOS), reasons for hospitalization, readmission, morbidity and mortality']","[{'cui': 'C4517769', 'cui_str': '408'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0186193', 'cui_str': 'Repair of hip'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}]","[{'cui': 'C0017710', 'cui_str': 'Glucocorticoid'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0038317', 'cui_str': 'Steroid'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0441074', 'cui_str': 'Meters'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0003297', 'cui_str': 'Antiemetic agent'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0037506', 'cui_str': 'Sodium lauryl sulfate'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",,0.22163,"Secondary outcomes include use of analgesics, rescue-opioids, antiemetics, cumulated pain, CRP, OR-SDS, QoR-15, quality of sleep, length of stay (LOS), reasons for hospitalization, readmission, morbidity and mortality.","[{'ForeName': 'Niklas I', 'Initials': 'NI', 'LastName': 'Nielsen', 'Affiliation': 'Department of Anaesthesiology, Copenhagen University, Hvidovre Hospital, Hvidovre, Denmark.'}, {'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Kehlet', 'Affiliation': 'Section of Surgical Pathophysiology, 7621, Rigshospitalet, University of Copenhagen, Blegdamsvej, Denmark.'}, {'ForeName': 'Kirill', 'Initials': 'K', 'LastName': 'Gromov', 'Affiliation': 'Department of Orthopedic Surgery, Copenhagen University, Hvidovre Hospital, Hvidovre, Denmark.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Troelsen', 'Affiliation': 'Department of Orthopedic Surgery, Copenhagen University, Hvidovre Hospital, Hvidovre, Denmark.'}, {'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Husted', 'Affiliation': 'Department of Orthopedic Surgery, Copenhagen University, Hvidovre Hospital, Hvidovre, Denmark.'}, {'ForeName': 'Claus', 'Initials': 'C', 'LastName': 'Varnum', 'Affiliation': 'Department of Orthopedic Surgery, Lillebaelt Hospital - Vejle, Vejle, Denmark.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Kjaersgaard-Andersen', 'Affiliation': 'Department of Orthopedic Surgery, Lillebaelt Hospital - Vejle, Vejle, Denmark.'}, {'ForeName': 'Lasse E', 'Initials': 'LE', 'LastName': 'Rasmussen', 'Affiliation': 'Department of Orthopedic Surgery, Lillebaelt Hospital - Vejle, Vejle, Denmark.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Mandøe', 'Affiliation': 'Department of Anaesthesiology, Lillebaelt Hospital -Vejle, Vejle, Denmark.'}, {'ForeName': 'Nicolai B', 'Initials': 'NB', 'LastName': 'Foss', 'Affiliation': 'Department of Anaesthesiology, Copenhagen University, Hvidovre Hospital, Hvidovre, Denmark.'}]",Acta anaesthesiologica Scandinavica,['10.1111/aas.13656'] 1751,32531622,Comparison of functional outcomes of cartilage tympanoplasty with silastic sheet versus Gelfoam packing in middle ear.,"BACKGROUND AND AIM Tympanoplasty is a common surgery in otorhinolaryngology field. In majority of procedures, in addition to the graft used for closure of tympanic membrane, a packing material is essential to be placed in the middle ear cavity. The main goals of packing can be summarized as providing support to the tympanic membrane and ossicular grafts, aeration of middle ear cavity and hemostasis. Several packing materials are currently available for using in middle ear surgeries. Each agent is associated with particular advantages and disadvantages, so choosing the proper packing agent is essential in tympanoplasty surgeries. In this study we aimed to compare two common packing materials (Gelfoam and silastic sheets) in cartilage tympanoplasty surgeries. METHODS AND MATERIALS In this block-randomized clinical trial, 78 patients undergoing tympanoplasty in Vali-e-asr hospital in 2017 and 2018 were enrolled. They were randomly assigned to silastic sheet or gelfoam groups. The functional outcomes were compared between the groups. Statistical analysis was performed by SPSS. RESULTS Success was achieved in 32 (82.1%) patients and 34 (87.2%) patients in gelfoam and silastic sheets' groups, respectively (p = 0.530). The perforation area percentage was significantly lower (P = 0.007) in Gelfoam group. The other parameters were statistically the same in both groups (P > 0.05). CONCLUSION Overall, Gelfoam and silastic sheet methods had similar efficacy in cartilage tympanoplasty. Using each method depends on the preferrence of surgeon and patients' characteristics. Multi-center studies with larger sample sizes are needed for more conclusive results.",2020,The perforation area percentage was significantly lower (P = 0.007) in Gelfoam group.,"['78 patients undergoing tympanoplasty in Vali-e-asr hospital in 2017 and 2018 were enrolled', 'middle ear']","['packing materials (Gelfoam and silastic sheets', 'cartilage tympanoplasty with silastic sheet versus Gelfoam packing', 'silastic sheet or gelfoam']","['Success', 'perforation area percentage']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0041447', 'cui_str': 'Repair of middle ear'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0013455', 'cui_str': 'Middle ear structure'}]","[{'cui': 'C1289829', 'cui_str': 'Packing material'}, {'cui': 'C0918040', 'cui_str': 'Gelfoam'}, {'cui': 'C0074517', 'cui_str': 'Silastic'}, {'cui': 'C0439643', 'cui_str': 'Sheets'}, {'cui': 'C0007301', 'cui_str': 'Cartilage tissue'}, {'cui': 'C0041447', 'cui_str': 'Repair of middle ear'}]","[{'cui': 'C0549099', 'cui_str': 'Perforation'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0439165', 'cui_str': 'Percent'}]",78.0,0.0554288,The perforation area percentage was significantly lower (P = 0.007) in Gelfoam group.,"[{'ForeName': 'Mahtab Rabbani', 'Initials': 'MR', 'LastName': 'Anari', 'Affiliation': 'Otorhinolaryngology Research Center, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Amir Miratashi', 'Initials': 'AM', 'LastName': 'Yazdi', 'Affiliation': 'Surgery Department, Sina Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Elnaz', 'Initials': 'E', 'LastName': 'Kazemi', 'Affiliation': 'Otorhinolaryngology Research Center, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Atie', 'Initials': 'A', 'LastName': 'Moghtadaie', 'Affiliation': 'Internal Medicine Department, Sina Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Abolfazl', 'Initials': 'A', 'LastName': 'Farbod', 'Affiliation': 'School of Medicine, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hamed', 'Initials': 'H', 'LastName': 'Emami', 'Affiliation': 'Otorhinolaryngology Research Center, Tehran University of Medical Sciences, Tehran, Iran. Electronic address: hd_emami@yahoo.com.'}]",American journal of otolaryngology,['10.1016/j.amjoto.2020.102588'] 1752,32534250,External trigeminal nerve stimulation for drug resistant epilepsy: A randomized controlled trial.,"BACKGROUND External trigeminal nerve stimulation (ETNS) is an emergent, non-invasive neurostimulation therapy delivered bilaterally with adhesive skin electrodes. In previous studies, ETNS was associated to a decrease in seizure frequency in patients with focal drug-resistant epilepsy (DRE). OBJECTIVE To determine the long-term efficacy and tolerability of ETNS in patients with focal DRE. Moreover, to explore whether its efficacy depends on the epileptogenic zone (frontal or temporal), and its impact on mood, cognitive function, quality of life, and trigeminal nerve excitability. METHODS Forty consecutive patients with frontal or temporal DRE, unsuitable for surgery, were randomized to ETNS or usual medical treatment. Participants were evaluated at 3, 6 and 12 months for efficacy, side effects, mood scales, neuropsychological tests and trigeminal nerve excitability. RESULTS Subjects had a median of 15 seizures per month and had tried a median of 12.5 antiepileptic drugs. At 12 months, percentage of responders was 50% in ETNS group and 0% in control group. Seizure frequency in ETNS group decreased by -43.5% from baseline. Temporal epilepsy subgroup responded better than frontal epilepsy subgroup (55.56% vs. 45.45%, respectively). Median stimulation intensity was 6.2 mA. ETNS improved quality of life, but not anxiety or depression. Long-term ETNS affected neither neuropsychological function, nor trigeminal nerve excitability. No relevant adverse events were observed. CONCLUSIONS ETNS is an effective and well-tolerated therapy for focal DRE. Patients with temporal epilepsy showed a better response than those with frontal epilepsy. Future studies with larger populations may define its role compared to other neurostimulation techniques. CLASSIFICATION OF EVIDENCE This study provides Class II evidence that ETNS reduces seizure frequency in patients with focal DRE.",2020,"Temporal epilepsy subgroup responded better than frontal epilepsy subgroup (55.56% vs. 45.45%, respectively).","['Patients with temporal epilepsy', 'Subjects had a median of 15 seizures per month and had tried a median of 12.5 antiepileptic drugs', 'patients with focal drug-resistant epilepsy (DRE', 'drug resistant epilepsy', 'Forty consecutive patients with frontal or temporal DRE, unsuitable for surgery', 'patients with focal DRE']","['ETNS or usual medical treatment', 'External trigeminal nerve stimulation (ETNS', 'ETNS', 'External trigeminal nerve stimulation']","['quality of life', 'seizure frequency', 'neuropsychological function, nor trigeminal nerve excitability', 'efficacy, side effects, mood scales, neuropsychological tests and trigeminal nerve excitability', 'Seizure frequency', 'Median stimulation intensity', 'adverse events', 'anxiety or depression', 'mood, cognitive function, quality of life, and trigeminal nerve excitability']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0442043', 'cui_str': 'Temporal'}, {'cui': 'C0014544', 'cui_str': 'Epilepsy'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C4517544', 'cui_str': '12.5'}, {'cui': 'C0003299', 'cui_str': 'ANTIEPILEPTICS'}, {'cui': 'C0205234', 'cui_str': 'Focal'}, {'cui': 'C1096063', 'cui_str': 'Refractory epilepsy'}, {'cui': 'C0205123', 'cui_str': 'Coronal'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0040996', 'cui_str': 'Trigeminal nerve structure'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0149775', 'cui_str': 'Fit frequency'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0040996', 'cui_str': 'Trigeminal nerve structure'}, {'cui': 'C0235169', 'cui_str': 'Excitability'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0027902', 'cui_str': 'Neuropsychological testing'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}]",40.0,0.130105,"Temporal epilepsy subgroup responded better than frontal epilepsy subgroup (55.56% vs. 45.45%, respectively).","[{'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Gil-López', 'Affiliation': ""Epilepsy Unit, Department of Neurology, Hospital Clínic de Barcelona, Barcelona, Spain, Institut D'Investigacions Biomediques August Pi I Sunyer (IDIBAPS), Barcelona, Spain. Electronic address: fran.gil.lopez@gmail.com.""}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Boget', 'Affiliation': 'Epilepsy Unit, Department of Neuropsychology, Hospital Clínic de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Manzanares', 'Affiliation': ""Epilepsy Unit, Department of Neurology, Hospital Clínic de Barcelona, Barcelona, Spain, Institut D'Investigacions Biomediques August Pi I Sunyer (IDIBAPS), Barcelona, Spain.""}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Donaire', 'Affiliation': ""Epilepsy Unit, Department of Neurology, Hospital Clínic de Barcelona, Barcelona, Spain, Institut D'Investigacions Biomediques August Pi I Sunyer (IDIBAPS), Barcelona, Spain.""}, {'ForeName': 'Estefanía', 'Initials': 'E', 'LastName': 'Conde-Blanco', 'Affiliation': ""Epilepsy Unit, Department of Neurology, Hospital Clínic de Barcelona, Barcelona, Spain, Institut D'Investigacions Biomediques August Pi I Sunyer (IDIBAPS), Barcelona, Spain.""}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Baillés', 'Affiliation': 'Epilepsy Unit, Department of Psychiatry, Hospital Clínic de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Pintor', 'Affiliation': 'Epilepsy Unit, Department of Psychiatry, Hospital Clínic de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Setoaín', 'Affiliation': 'Epilepsy Unit, Department of Nuclear Medicine, Hospital Clínic de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Núria', 'Initials': 'N', 'LastName': 'Bargalló', 'Affiliation': 'Epilepsy Unit, Department of Neurorradiology, Hospital Clínic de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Navarro', 'Affiliation': 'Electromyography Unit, Neurophysiology, Department of Neurology, Hospital Clínic de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Casanova', 'Affiliation': 'Electromyography Unit, Neurophysiology, Department of Neurology, Hospital Clínic de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Josep', 'Initials': 'J', 'LastName': 'Valls', 'Affiliation': 'Electromyography Unit, Neurophysiology, Department of Neurology, Hospital Clínic de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Roldán', 'Affiliation': 'Epilepsy Unit, Department of Neurosurgery, Hospital Clínic de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Rumià', 'Affiliation': 'Epilepsy Unit, Department of Neurosurgery, Hospital Clínic de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Georgina', 'Initials': 'G', 'LastName': 'Casanovas', 'Affiliation': 'Medical Statistics Core Facility, IDIBAPS-Hospital Clínic, Barcelona, Spain.'}, {'ForeName': 'Gema', 'Initials': 'G', 'LastName': 'Domenech', 'Affiliation': 'Medical Statistics Core Facility, IDIBAPS-Hospital Clínic, Barcelona, Spain.'}, {'ForeName': 'Ferrán', 'Initials': 'F', 'LastName': 'Torres', 'Affiliation': 'Medical Statistics Core Facility, IDIBAPS-Hospital Clínic, Barcelona, Spain.'}, {'ForeName': 'Mar', 'Initials': 'M', 'LastName': 'Carreño', 'Affiliation': ""Epilepsy Unit, Department of Neurology, Hospital Clínic de Barcelona, Barcelona, Spain, Institut D'Investigacions Biomediques August Pi I Sunyer (IDIBAPS), Barcelona, Spain.""}]",Brain stimulation,['10.1016/j.brs.2020.06.005'] 1753,32534252,"Two weeks of image-guided left dorsolateral prefrontal cortex repetitive transcranial magnetic stimulation improves smoking cessation: A double-blind, sham-controlled, randomized clinical trial.","BACKGROUND Previous studies have found that repetitive transcranial magnetic stimulation (rTMS) to the left dorsal lateral prefrontal cortex (LDLPFC) transiently reduces smoking craving, decreases cigarette consumption, and increases abstinence rates. OBJECTIVE We investigated whether 10 daily MRI-guided rTMS sessions over two weeks to the LDLPFC paired with craving cues could reduce cigarette consumption and induce smoking cessation. METHODS We enrolled 42 treatment-seeking nicotine-dependent smokers (≥10 cigarettes per day) in a randomized, double-blind, sham-controlled trial. Participants received 10 daily sessions over 2 weeks of either active or sham MRI-guided rTMS (10Hz, 3000 pulses each session) to the LDLPFC concurrently with video smoking cues. The primary outcome was a reduction in biochemically confirmed cigarette consumption with a secondary outcome of abstinence on the target quit date. We also recorded cue-induced craving and withdrawal symptoms. RESULTS Compared to sham (n = 17), participants receiving active rTMS (n = 21) smoked significantly fewer cigarettes per day during the 2-week treatment (mean [SD], 13.73[9.18] vs. 11.06[9.29], P < .005) and at 1-month follow-up (12.78[9.53] vs. 7.93[7.24], P < .001). Active rTMS participants were also more likely to quit by their target quit rate (23.81%vs. 0%, OR 11.67, 90% CL, 0.96-141.32, x 2  = 4.66, P = .031). Furthermore, rTMS significantly reduced mean craving throughout the treatments and at follow-up (29.93[13.12] vs. 25.01[14.45], P < .001). Interestingly across the active treatment sample, more lateral coil location was associated with more success in quitting (-43.43[0.40] vs. -41.79[2.24], P < .013). CONCLUSIONS Daily MRI-guided rTMS to the LDLPFC for 10 days reduces cigarette consumption and cued craving for up to one month and also increases the likelihood of smoking cessation. TRIAL REGISTRATION ClinicalTrials.gov identifier: NCT02401672.",2020,"Compared to sham (n=17), participants receiving active rTMS (n=21) smoked significantly fewer cigarettes per day during the 2-week treatment (mean [SD], 13.73[9.18] vs. 11.06[9.29], P<.005) and at 1-month follow-up (12.78[9.53] vs. 7.93[7.24], P<.001).",['enrolled 42 treatment-seeking nicotine-dependent smokers (≥10 cigarettes per day'],"['rTMS', 'Image-guided Left Dorsolateral Prefrontal Cortex Repetitive Transcranial Magnetic Stimulation Improves Smoking Cessation', 'active rTMS', 'repetitive transcranial magnetic stimulation (rTMS', 'LDLPFC paired with craving cues', 'active or sham MRI-guided rTMS (10Hz, 3000 pulses each session) to the LDLPFC concurrently with video smoking cues']","['abstinence on the target quit date', 'likelihood of smoking cessation', 'lateral coil location', 'cigarette consumption and cued craving', 'mean craving', 'likely to quit by their target quit rate']","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0439505', 'cui_str': '/day'}]","[{'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C4019080', 'cui_str': 'Prefrontal Cortex, Dorsolateral'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0162783', 'cui_str': 'Prefrontal Cortex'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0470279', 'cui_str': '3000'}, {'cui': 'C0034107', 'cui_str': 'Pulse taking'}, {'cui': 'C0450424', 'cui_str': 'To the left'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}]","[{'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0011008', 'cui_str': 'Date'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0337671', 'cui_str': 'Ex-smoker'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0419518', 'cui_str': 'Contraceptive coil'}, {'cui': 'C0450429', 'cui_str': 'Location'}, {'cui': 'C0459840', 'cui_str': 'Cigarette consumption'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis'}]",42.0,0.428626,"Compared to sham (n=17), participants receiving active rTMS (n=21) smoked significantly fewer cigarettes per day during the 2-week treatment (mean [SD], 13.73[9.18] vs. 11.06[9.29], P<.005) and at 1-month follow-up (12.78[9.53] vs. 7.93[7.24], P<.001).","[{'ForeName': 'Xingbao', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC, 29425, USA; Center for Biomedical Imaging, Medical University of South Carolina, Charleston, SC, 29425, USA. Electronic address: lixi@musc.edu.'}, {'ForeName': 'Karen J', 'Initials': 'KJ', 'LastName': 'Hartwell', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC, 29425, USA; Ralph H. Johnson VA Medical Center, Charleston, SC, 29401, USA.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Henderson', 'Affiliation': 'Center for Biomedical Imaging, Medical University of South Carolina, Charleston, SC, 29425, USA.'}, {'ForeName': 'Bashar W', 'Initials': 'BW', 'LastName': 'Badran', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC, 29425, USA.'}, {'ForeName': 'Kathleen T', 'Initials': 'KT', 'LastName': 'Brady', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC, 29425, USA; Ralph H. Johnson VA Medical Center, Charleston, SC, 29401, USA.'}, {'ForeName': 'Mark S', 'Initials': 'MS', 'LastName': 'George', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC, 29425, USA; Ralph H. Johnson VA Medical Center, Charleston, SC, 29401, USA.'}]",Brain stimulation,['10.1016/j.brs.2020.06.007'] 1754,32534361,Long-term effects of mindfulness-based cognitive therapy in patients with obsessive-compulsive disorder and residual symptoms after cognitive behavioral therapy: Twelve-month follow-up of a randomized controlled trial.,"We examined the long-term efficacy of mindfulness-based cognitive therapy (MBCT) compared to a psychoeducation group as an active control condition in patients with obsessive-compulsive disorder (OCD) with residual symptoms of OCD after cognitive behavioral therapy. A total of 125 patients were included in a bicentric, interviewer-blind, randomized, and actively controlled trial and were assigned to either an MBCT group (n = 61) or a psychoeducation group (n = 64). Patients' demographic characteristics and the results from our previous assessments have already been reported (Külz et al., 2019). At the 12-month follow-up the completion rate was 80%. OCD symptoms were reduced from baseline to follow-up assessment with a large effect, but no difference was found between groups. Exploratory analyses showed that a composite score of time occupied by obsessive thoughts, distress associated with obsessive thoughts, and interference due to obsessive thoughts differed between groups in the per-protocol analysis, with a stronger reduction in the MBCT group. At the 12-month follow-up, the two groups showed a similar reduction of symptoms. However, preliminary evidence indicates that MBCT has a superior effect on some aspects of OCD. This should be replicated in future studies.",2020,"OCD symptoms were reduced from baseline to follow-up assessment with a large effect, but no difference was found between groups.","['patients with obsessive-compulsive disorder and residual symptoms after cognitive behavioral therapy', 'patients with obsessive-compulsive disorder (OCD) with residual symptoms of OCD after cognitive behavioral therapy', 'A total of 125 patients']","['MBCT', 'mindfulness-based cognitive therapy', 'mindfulness-based cognitive therapy (MBCT']","['OCD symptoms', 'composite score of time occupied by obsessive thoughts, distress associated with obsessive thoughts, and interference due to obsessive thoughts']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0028768', 'cui_str': 'Obsessive-compulsive disorder'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4319551', 'cui_str': '125'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C0028768', 'cui_str': 'Obsessive-compulsive disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0679048', 'cui_str': 'Obsessive thoughts'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0678226', 'cui_str': 'Due to'}]",125.0,0.0493293,"OCD symptoms were reduced from baseline to follow-up assessment with a large effect, but no difference was found between groups.","[{'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Cludius', 'Affiliation': 'University Medical Center Hamburg-Eppendorf, Department of Psychiatry and Psychotherapy, Martinistr, 52, 20246 Hamburg, Germany. Electronic address: barbara.cludius@psy.lmu.de.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Landmann', 'Affiliation': 'University Medical Center Freiburg, Department of Psychiatry and Psychotherapy, Hauptstr. 6, 79104 Freiburg, Germany.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Rose', 'Affiliation': 'University Medical Center Freiburg, Department of Psychiatry and Psychotherapy, Hauptstr. 6, 79104 Freiburg, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Heidenreich', 'Affiliation': 'Esslingen University of Applied Sciences; Flandernstraße 101, 73732 Esslingen am Neckar, Germany.'}, {'ForeName': 'Birgit', 'Initials': 'B', 'LastName': 'Hottenrott', 'Affiliation': 'University Medical Center Hamburg-Eppendorf, Department of Psychiatry and Psychotherapy, Martinistr, 52, 20246 Hamburg, Germany.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Schröder', 'Affiliation': 'University Medical Center Hamburg-Eppendorf, Department of Psychiatry and Psychotherapy, Martinistr, 52, 20246 Hamburg, Germany; Institute for Sex Research, Sexual Medicine and Forensic Psychiatry, Germany.'}, {'ForeName': 'Lena', 'Initials': 'L', 'LastName': 'Jelinek', 'Affiliation': 'University Medical Center Hamburg-Eppendorf, Department of Psychiatry and Psychotherapy, Martinistr, 52, 20246 Hamburg, Germany.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Voderholzer', 'Affiliation': 'University Medical Center Freiburg, Department of Psychiatry and Psychotherapy, Hauptstr. 6, 79104 Freiburg, Germany;; Schoen Clinic Roseneck, Am Roseneck 6, 83209 Prien am Chiemsee, Germany; Clinic for Psychiatry and Psychotherapy, Ludwig-Maximilians-University, Nußbaumstraße 7, 80336 Munich, Germany.'}, {'ForeName': 'Anne Katrin', 'Initials': 'AK', 'LastName': 'Külz', 'Affiliation': 'University Medical Center Freiburg, Department of Psychiatry and Psychotherapy, Hauptstr. 6, 79104 Freiburg, Germany.'}, {'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Moritz', 'Affiliation': 'University Medical Center Hamburg-Eppendorf, Department of Psychiatry and Psychotherapy, Martinistr, 52, 20246 Hamburg, Germany.'}]",Psychiatry research,['10.1016/j.psychres.2020.113119'] 1755,32534369,Hydroxychloroquine/ chloroquine as a treatment choice or prophylaxis for Covid-19 at the primary care level in developing countries: A Primum non Nocere dilemma.,"The Food and Drug Administration (FDA) warned against the use of Hydroxychloroquine or chloroquine for Covid-19 outside of a hospital or a clinical trial setting due to the risk of QT interval prolongation, ventricular tachycardia and the increased risk of these complications when combined with some antibiotics such as azithromycin. Several studies have reported no benefit of Hydroxychloroquine or chloroquine, when used alone or with a macrolide in COVID-19 hospitalized patients. Despite these warnings, in several developing countries the official guidelines for treatment of Covid-19 patients at the primary care level recommend Hydroxychloroquine and azithromycin, among other treatments, as the first-choice for mild symptomatic Covid-19 patients, asymptomatic contacts or for prophylaxis. In our opinion there is a primum non nocere dilemma during this Covid-19 pandemic. In order to solve this bioethical problem, we strongly recommend that a randomized controlled trial in a primary care setting be carried out as a matter of urgency in these areas of the world.",2020,"Several studies have reported no benefit of Hydroxychloroquine or chloroquine, when used alone or with a macrolide in COVID-19 hospitalized patients.",['COVID-19 hospitalized patients'],"['azithromycin', 'Hydroxychloroquine/ chloroquine', 'Hydroxychloroquine or chloroquine', 'Hydroxychloroquine and azithromycin']",[],"[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0052796', 'cui_str': 'Azithromycin'}, {'cui': 'C0008269', 'cui_str': 'Chloroquine'}, {'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}]",[],,0.0510268,"Several studies have reported no benefit of Hydroxychloroquine or chloroquine, when used alone or with a macrolide in COVID-19 hospitalized patients.","[{'ForeName': 'Marco T', 'Initials': 'MT', 'LastName': 'Medina', 'Affiliation': 'Faculty of Medical Sciences, National Autonomous University of Honduras, WFN Regional Director for Latin America, Tegucigalpa, Honduras. Electronic address: marcotmedina@yahoo.com.'}, {'ForeName': 'Sir Salvador', 'Initials': 'SS', 'LastName': 'Moncada', 'Affiliation': 'Manchester Cancer Research Centre, The University of Manchester, Manchester, UK.'}]",Journal of the neurological sciences,['10.1016/j.jns.2020.116972'] 1756,32534376,Fatty acid desaturation in red blood cell membranes of patients with type 2 diabetes is improved by zinc supplementation.,"BACKGROUND/OBJECTIVE Membrane flexibility can be a determining factor in pathophysiological mechanisms of type 2 diabetes (T2D). As a cofactor of delta-5 desaturase (D5D) and delta-6 desaturase (D6D), and gene expression regulator, zinc may play a role modulating membrane flexibility by increasing membrane polyunsaturated fatty acids (PUFA) abundance. The objective of this study was to evaluate the effect of a 24-month zinc supplementation (30 mg elemental zinc) on membrane fatty acid composition in patients with T2D. SUBJECTS/METHODS Sixty patients with T2D were evaluated. Thirty were randomly assigned to the zinc supplemented group and thirty to the placebo group. Fatty acid composition in red blood cell (RBC) membranes was determined by gas chromatography. Expression of gene encoding for D5D (FADS1), and D6D (FADS2) were evaluated in peripheral blood mononuclear cells by real-time polymerase chain reaction. RESULTS After 24 months of supplementation, a greater abundance of docosapentaenoic acid (C22:5 n-3), arachidonic acid (C20:4 n-6), adrenic acid (C22:4 n-6), and total n-6 PUFA was found (p = 0.001, p = 0.007, p = 0.033, p = 0.048, respectively). The unsaturated fatty acids/saturated fatty acids ratio, and unsaturation index was increased in the zinc supplemented group at month 24 (p = 0.003 and p  = 0.000, respectively). FADS1 gene was upregulated in the zinc group in relation to placebo at month 12 (p = 0.020). CONCLUSIONS Supplementation with 30 mg/d elemental zinc during 24 months in patients with T2D had an effect on the composition of RBC membranes increasing PUFA abundance and in turn, improving membrane flexibility. This effect may be mediated by induction of D5D gene expression.",2020,"FADS1 gene was upregulated in the zinc group in relation to placebo at month 12 (p = 0.020). ","['patients with T2D', 'Sixty patients with T2D were evaluated', 'patients with type 2 diabetes']","['Fatty acid desaturation', 'zinc supplementation (30\u202fmg elemental zinc', 'placebo']","['membrane flexibility', 'Expression of gene encoding for D5D (FADS1), and D6D (FADS2', 'Fatty acid composition in red blood cell (RBC) membranes', 'abundance of docosapentaenoic acid (C22:5 n-3), arachidonic acid (C20:4 n-6), adrenic acid (C22:4 n-6), and total n-6 PUFA', 'FADS1 gene', 'unsaturated fatty acids/saturated fatty acids ratio, and unsaturation index', 'membrane fatty acid composition']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0746961', 'cui_str': 'Oxygen saturation below reference range'}, {'cui': 'C4524022', 'cui_str': 'Zinc supplementation'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0025255', 'cui_str': 'Membrane Tissue'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C0057338', 'cui_str': 'delta-5 fatty acid desaturase'}, {'cui': 'C0065017', 'cui_str': 'Linoleoyl-CoA desaturase'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0014772', 'cui_str': 'Red blood cell count'}, {'cui': 'C0058624', 'cui_str': 'docosapentaenoic acid'}, {'cui': 'C0003695', 'cui_str': 'Arachidonic acid'}, {'cui': 'C0050877', 'cui_str': 'adrenic acid'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1276035', 'cui_str': 'Pena-Shokeir syndrome type I'}, {'cui': 'C0015690', 'cui_str': 'Unsaturated fatty acid'}, {'cui': 'C0597423', 'cui_str': 'Saturated fat'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",60.0,0.126956,"FADS1 gene was upregulated in the zinc group in relation to placebo at month 12 (p = 0.020). ","[{'ForeName': 'María Catalina', 'Initials': 'MC', 'LastName': 'Hernández', 'Affiliation': 'From the Department of Nutrition, Faculty of Medicine, University of Chile, Santiago, Chile.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Rojas', 'Affiliation': 'From the Department of Nutrition, Faculty of Medicine, University of Chile, Santiago, Chile.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Carrasco', 'Affiliation': 'From the Department of Nutrition, Faculty of Medicine, University of Chile, Santiago, Chile.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Basfi-Fer', 'Affiliation': 'From the Department of Nutrition, Faculty of Medicine, University of Chile, Santiago, Chile.'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Valenzuela', 'Affiliation': 'From the Department of Nutrition, Faculty of Medicine, University of Chile, Santiago, Chile.'}, {'ForeName': 'Juana', 'Initials': 'J', 'LastName': 'Codoceo', 'Affiliation': 'From the Department of Nutrition, Faculty of Medicine, University of Chile, Santiago, Chile.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Inostroza', 'Affiliation': 'From the Department of Nutrition, Faculty of Medicine, University of Chile, Santiago, Chile.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Ruz', 'Affiliation': 'From the Department of Nutrition, Faculty of Medicine, University of Chile, Santiago, Chile. Electronic address: mruz@med.uchile.cl.'}]",Journal of trace elements in medicine and biology : organ of the Society for Minerals and Trace Elements (GMS),['10.1016/j.jtemb.2020.126571'] 1757,32558047,Introduction of mini-clinical evaluation exercise in teaching dental radiology-A pilot study.,"INTRODUCTION Workplace-based assessments are methods that can be applied for assessing competence and performance. One of these methods is the mini-clinical evaluation exercise (mini-CEX). This study was conducted to determine the role of mini-CEX in students' performance assessment on panoramic X-ray reporting at dental radiology course. MATERIALS AND METHODS A workshop as training for the assessors and the participants was conducted before the primary test. All participants (n = 36) were randomly allocated into six groups. Each group had three seminars in which every student reported a panoramic X-ray. Students were directly observed and rated by an assessor on a modified mini-CEX rating form. Then, a self-assessment of the students and a systematic feedback session were performed. Finally, the students and the assessors were evaluated for the acceptability and satisfaction with this tool. RESULTS The mean duration of the assessment and the feedback decreased significantly from the first seminar to the third seminar (P < .0001). Comparison of the results of the mini-CEX of all three assessments showed that students displayed a significantly better performance in evaluating the upper jaw and the soft tissue (P < .05). There was no significant improvement for the other aspects of the rating form. Overall, both students and assessors reported a high level of satisfaction in using the mini-CEX rating form. CONCLUSION Due to the objectivity and transparency of the assessment, the mini-CEX helped to improve the performance on reporting panoramic X-rays. Besides that, the structured feedback had major impact on the improvement. Overall, the assessors and the participants reported a high level of satisfaction using the rating form. Therefore, the mini-CEX may be an effective method for performing workplace-based assessments to evaluate students' performance on reporting panoramic X-rays.",2020,The mean duration of the assessment and the feedback decreased significantly from the first seminar to the third seminar (p < 0.0001).,"['All participants (n = 36', ""students' performance assessment on panoramic x-ray reporting at dental radiology course""]","['mini-clinical evaluation exercise', 'mini-CEX']","['acceptability and satisfaction', 'mean duration of the assessment and the feedback']","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0034571', 'cui_str': 'radiography'}, {'cui': 'C0011365', 'cui_str': 'Health Services, Dental'}, {'cui': 'C0034599', 'cui_str': 'Radiology - specialty'}, {'cui': 'C0750729', 'cui_str': 'Courses'}]","[{'cui': 'C0445542', 'cui_str': 'Mini'}, {'cui': 'C1261322', 'cui_str': 'Evaluation procedure'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}]",36.0,0.0264222,The mean duration of the assessment and the feedback decreased significantly from the first seminar to the third seminar (p < 0.0001).,"[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Bock', 'Affiliation': 'Department of Oral, Maxillofacial Surgery, University Hospital of Aachen University, Aachen, Germany.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Peters', 'Affiliation': 'Department of Oral, Maxillofacial Surgery, University Hospital of Aachen University, Aachen, Germany.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Elvers', 'Affiliation': 'Department of Oral, Maxillofacial Surgery, University Hospital of Aachen University, Aachen, Germany.'}, {'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Wittenborn', 'Affiliation': 'Department of Oral, Maxillofacial Surgery, University Hospital of Aachen University, Aachen, Germany.'}, {'ForeName': 'Kristian', 'Initials': 'K', 'LastName': 'Kniha', 'Affiliation': 'Department of Oral, Maxillofacial Surgery, University Hospital of Aachen University, Aachen, Germany.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Gerressen', 'Affiliation': 'Department of Oral, Maxillofacial and Plastic Facial Surgery, Heinrich Braun Hospital, Zwickau, Germany.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Hölzle', 'Affiliation': 'Department of Oral, Maxillofacial Surgery, University Hospital of Aachen University, Aachen, Germany.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Modabber', 'Affiliation': 'Department of Oral, Maxillofacial Surgery, University Hospital of Aachen University, Aachen, Germany.'}]",European journal of dental education : official journal of the Association for Dental Education in Europe,['10.1111/eje.12558'] 1758,32558215,Using Nonparticipant Observation as a Method to Understand Implementation Context in Evidence-Based Practice.,"BACKGROUND The uptake of evidence-based knowledge in practice is influenced by context. Observations are suggested as a valuable but under-used approach in implementation research for gaining a holistic understanding of contexts. AIM The aim of this paper is to demonstrate how data from observations can provide insights about context and evidence use in implementation research. METHODS Data were collected over 24 months in a randomised trial with an embedded realist evaluation in 24 nursing homes across four European countries; notes from 183 observations (representing 335 hours) were triangulated with interview transcripts and context survey data (from 357 staff interviews and 725 questionnaire responses, respectively). RESULTS Although there were similarities in several elements of context within survey, interview and observation data, the observations provided additional features of the implementation context. In particular, observations demonstrated if and how the resources (staffing and supplies) and leadership (formal and informal, teamwork, and professional autonomy) affected knowledge use and implementation. Further, the observations illuminated the influence of standards and the physical nursing environment on evidence-based practice, and the dynamic interaction between different aspects of context. LINKING EVIDENCE TO ACTION Although qualitative observations are resource-intensive, they add value when used with other data collection methods, further enlightening the understanding of the implementation context and how evidence use and sharing are influenced by context elements. Observations can enhance an understanding of the context, evidence use and knowledge-sharing triad in implementation research.",2020,"Although there were similarities in several elements of context within survey, interview and observation data, the observations provided additional features of the implementation context.","['Data were collected over 24\xa0months in a randomised trial with an embedded realist evaluation in 24 nursing homes across four European countries; notes from 183 observations (representing 335 hours) were triangulated with interview transcripts and context survey data (from 357 staff interviews and 725 questionnaire responses, respectively']",[],[],"[{'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0028688', 'cui_str': 'Long term care facility'}, {'cui': 'C0454713', 'cui_str': 'European country'}, {'cui': 'C4517615', 'cui_str': '183'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C4709307', 'cui_str': '335'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0449255', 'cui_str': 'Context'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",[],[],,0.0495672,"Although there were similarities in several elements of context within survey, interview and observation data, the observations provided additional features of the implementation context.","[{'ForeName': 'Ann Catrine', 'Initials': 'AC', 'LastName': 'Eldh', 'Affiliation': 'Department of Medicine and Health, Linkoping University, Linkoping, Sweden.'}, {'ForeName': 'Jo', 'Initials': 'J', 'LastName': 'Rycroft-Malone', 'Affiliation': 'Department of Health Research, Faculty of Health and Medicine, Lancaster University, Lancaster, UK.'}, {'ForeName': 'Teatske', 'Initials': 'T', 'LastName': 'van der Zijpp', 'Affiliation': 'Fontys School of People and Health Studies, Fontys University of Applied Sciences, Eindhoven, The Netherlands.'}, {'ForeName': 'Christel', 'Initials': 'C', 'LastName': 'McMullan', 'Affiliation': 'Institute of Applied Health Research, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Hawkes', 'Affiliation': 'Warwick Clinical Trials Unit, Warwick Medical School, University of Warwick, Coventry, UK.'}]",Worldviews on evidence-based nursing,['10.1111/wvn.12449'] 1759,32553118,"Berzosertib plus gemcitabine versus gemcitabine alone in platinum-resistant high-grade serous ovarian cancer: a multicentre, open-label, randomised, phase 2 trial.","BACKGROUND High-grade serous ovarian cancers show increased replication stress, rendering cells vulnerable to ATR inhibition because of near universal loss of the G1/S checkpoint (through deleterious TP53 mutations), premature S phase entry (due to CCNE1 amplification, RB1 loss, or CDKN2A mRNA downregulation), alterations of homologous recombination repair genes, and expression of oncogenic drivers (through MYC amplification and other mechanisms). We hypothesised that the combination of the selective ATR inhibitor, berzosertib, and gemcitabine could show acceptable toxicity and superior efficacy to gemcitabine alone in high-grade serous ovarian cancer. METHODS In this multicentre, open-label, randomised, phase 2 study, 11 different centres in the US Experimental Therapeutics Clinical Trials Network enrolled women (aged ≥18 years) with recurrent, platinum-resistant high-grade serous ovarian cancer (determined histologically) and Eastern Cooperative Oncology Group performance status of 0 or 1, who had unlimited previous lines of cytotoxic therapy in the platinum-sensitive setting but no more than one line of cytotoxic therapy in the platinum-resistant setting. Eligible patients were randomly assigned (1:1) to receive intravenous gemcitabine (1000 mg/m 2 ) on day 1 and day 8, or gemcitabine plus intravenous berzosertib (210 mg/m 2 ) on day 2 and day 9 of a 21-day cycle until disease progression or intolerable toxicity. Randomisation was done centrally using the Theradex Interactive Web Response System, stratified by platinum-free interval, and with a permuted block size of six. Following central randomisation, patients and investigators were not masked to treatment assignment. The primary endpoint was investigator-assessed progression-free survival, and analyses included all patients who received at least one dose of the study drugs. The study is registered with ClinicalTrials.gov, NCT02595892, and is active but closed to enrolment. FINDINGS Between Feb 14, 2017, and Sept 7, 2018, 88 patients were assessed for eligibility, of whom 70 were randomly assigned to treatment with gemcitabine alone (36 patients) or gemcitabine plus berzosertib (34 patients). At the data cutoff date (Feb 21, 2020), the median follow-up was 53·2 weeks (25·6-81·8) in the gemcitabine plus berzosertib group and 43·0 weeks (IQR 23·2-69·1) in the gemcitabine alone group. Median progression-free survival was 22·9 weeks (17·9-72·0) for gemcitabine plus berzosertib and 14·7 weeks (90% CI 9·7-36·7) for gemcitabine alone (hazard ratio 0·57, 90% CI 0·33-0·98; one-sided log-rank test p=0·044). The most common treatment-related grade 3 or 4 adverse events were decreased neutrophil count (14 [39%] of 36 patients in the gemcitabine alone group vs 16 [47%] of 34 patients in the gemcitabine plus berzosertib group) and decreased platelet count (two [6%] vs eight [24%]). Serious adverse events were observed in ten (28%) patients in the gemcitabine alone group and nine (26%) patients in the gemcitabine plus berzosertib group. There was one treatment-related death in the gemcitabine alone group due to sepsis and one treatment-related death in the gemcitabine plus berzosertib group due to pneumonitis. INTERPRETATION To our knowledge, this is the first randomised study of an ATR inhibitor in any tumour type. This study shows a benefit of adding berzosertib to gemcitabine in platinum-resistant high-grade serous ovarian cancer. This combination warrants further investigation in this setting. FUNDING US National Cancer Institute.",2020,"Median progression-free survival was 22·9 weeks (17·9-72·0) for gemcitabine plus berzosertib and 14·7 weeks (90% CI 9·7-36·7) for gemcitabine alone (hazard ratio 0·57, 90% CI 0·33-0·98; one-sided log-rank test p=0·044).","['platinum-resistant high-grade serous ovarian cancer', '88 patients were assessed for eligibility, of whom 70', '11 different centres in the US Experimental Therapeutics Clinical Trials Network enrolled women (aged ≥18 years) with recurrent, platinum-resistant high-grade serous ovarian cancer (determined histologically) and Eastern Cooperative Oncology Group performance status of 0 or 1, who had unlimited previous lines of cytotoxic therapy in the platinum-sensitive setting but no more than one line of cytotoxic therapy in the platinum-resistant setting', 'Eligible patients', 'Between Feb 14, 2017, and Sept 7, 2018']","['Berzosertib plus gemcitabine', 'gemcitabine plus intravenous berzosertib', 'gemcitabine alone', 'intravenous gemcitabine', 'gemcitabine plus berzosertib', 'gemcitabine', 'berzosertib to gemcitabine']","['platelet count', 'Median progression-free survival', 'neutrophil count', 'death', 'investigator-assessed progression-free survival', 'Serious adverse events']","[{'cui': 'C0032207', 'cui_str': 'Platinum'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0440743', 'cui_str': 'Serous'}, {'cui': 'C0919267', 'cui_str': 'Neoplasm of ovary'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C1520224', 'cui_str': 'ECOG performance status'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0233535', 'cui_str': 'Butting'}, {'cui': 'C0439093', 'cui_str': '>'}]","[{'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}]","[{'cui': 'C0032181', 'cui_str': 'Platelet count'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0200633', 'cui_str': 'Neutrophil count'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",88.0,0.0861426,"Median progression-free survival was 22·9 weeks (17·9-72·0) for gemcitabine plus berzosertib and 14·7 weeks (90% CI 9·7-36·7) for gemcitabine alone (hazard ratio 0·57, 90% CI 0·33-0·98; one-sided log-rank test p=0·044).","[{'ForeName': 'Panagiotis A', 'Initials': 'PA', 'LastName': 'Konstantinopoulos', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA. Electronic address: panagiotis_konstantinopoulos@dfci.harvard.edu.'}, {'ForeName': 'Su-Chun', 'Initials': 'SC', 'LastName': 'Cheng', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.'}, {'ForeName': 'Andrea E', 'Initials': 'AE', 'LastName': 'Wahner Hendrickson', 'Affiliation': 'Department of Medical Oncology, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Richard T', 'Initials': 'RT', 'LastName': 'Penson', 'Affiliation': 'Department of Medical Oncology, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Susan T', 'Initials': 'ST', 'LastName': 'Schumer', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.'}, {'ForeName': 'L Austin', 'Initials': 'LA', 'LastName': 'Doyle', 'Affiliation': 'Department of Cancer Treatment and Diagnosis, National Cancer Institute, Bethesda, MD, USA.'}, {'ForeName': 'Elizabeth K', 'Initials': 'EK', 'LastName': 'Lee', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.'}, {'ForeName': 'Elise C', 'Initials': 'EC', 'LastName': 'Kohn', 'Affiliation': 'Department of Cancer Treatment and Diagnosis, National Cancer Institute, Bethesda, MD, USA.'}, {'ForeName': 'Linda R', 'Initials': 'LR', 'LastName': 'Duska', 'Affiliation': 'Department of Obstetrics and Gynecology, Cancer Center, University of Virginia, Charlottesville, VA, USA.'}, {'ForeName': 'Marta A', 'Initials': 'MA', 'LastName': 'Crispens', 'Affiliation': 'Department of Obstetrics and Gynecology, Ingram Cancer Center, Vanderbilt University Nashville, TN, USA.'}, {'ForeName': 'Alexander B', 'Initials': 'AB', 'LastName': 'Olawaiye', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Pittsburgh Cancer Institute, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Ira S', 'Initials': 'IS', 'LastName': 'Winer', 'Affiliation': 'Department of Obstetrics and Gynecology, Karmanos Cancer Institute, Wayne State University, Detroit, MI, USA.'}, {'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'Barroilhet', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Wisconsin Hospital and Clinics, Madison, WI, USA.'}, {'ForeName': 'Siqing', 'Initials': 'S', 'LastName': 'Fu', 'Affiliation': 'Department of Investigational Cancer Therapeutics, MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Michael T', 'Initials': 'MT', 'LastName': 'McHale', 'Affiliation': 'Department of Obstetrics and Gynecology, Moores Cancer Center, University of California San Diego, San Diego, CA, USA.'}, {'ForeName': 'Russell J', 'Initials': 'RJ', 'LastName': 'Schilder', 'Affiliation': 'Department of Medical Oncology, Sidney Kimmel Cancer Center, Thomas Jefferson University, Philadelphia, PA, USA.'}, {'ForeName': 'Anniina', 'Initials': 'A', 'LastName': 'Färkkilä', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.'}, {'ForeName': 'Dipanjan', 'Initials': 'D', 'LastName': 'Chowdhury', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Curtis', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.'}, {'ForeName': 'Roxanne S', 'Initials': 'RS', 'LastName': 'Quinn', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.'}, {'ForeName': 'Brittany', 'Initials': 'B', 'LastName': 'Bowes', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.'}, {'ForeName': 'Alan D', 'Initials': 'AD', 'LastName': ""D'Andrea"", 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.'}, {'ForeName': 'Geoffrey I', 'Initials': 'GI', 'LastName': 'Shapiro', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.'}, {'ForeName': 'Ursula A', 'Initials': 'UA', 'LastName': 'Matulonis', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA.'}]",The Lancet. Oncology,['10.1016/S1470-2045(20)30180-7'] 1760,32556354,"Efficacy of radial extracorporeal shock wave therapy compared with botulinum toxin type A injection in treatment of lower extremity spasticity in subjects with cerebral palsy: A randomized, controlled, cross-over study.","OBJECTIVES To investigate whether botulinum toxin type A (BTX-A) injection is more effective than radial extracorporeal shock wave therapy in reducing plantar flexor muscle spasticity in subjects with cerebral palsy. METHODS A total of 68 subjects with cerebral palsy were randomly allocated to BTX-A injection (Group 1) or radial extracorporeal shock wave therapy (Group 2) (first experiment; E1). Outcome was evaluated using the Tardieu V1 and V3 stretches, at 3 weeks, 2 months (M2) and M3 after baseline. At M6 subjects in Group 1 received radial extracorporeal shock wave therapy and subjects in Group 2 received BTX-A injection (second experiment; E2); outcome was evaluated as in E1. Treatment success was defined as improvement in foot dorsiflexion ≥10° when performing the V3 stretch at M2 in both experiments. RESULTS In both experiments mean V1 and V3 significantly improved over time. In E1 both treatments resulted in similar treatment success. In E2 fewer subjects treated with BTX-A injection reached the criteria of treatment success than did subjects treated with radial extracorporeal shock wave therapy, which was due to a carry-over effect from E1. No significant complications were observed. CONCLUSION BTX-A injection is not superior to radial extracorporeal shock wave therapy in the treatment of plantar flexor muscle spasticity in subjects with cerebral palsy.",2020,BTX-A injection is not superior to radial extracorporeal shock wave therapy in the treatment of plantar flexor muscle spasticity in subjects with cerebral palsy.,"['subjects with cerebral palsy', '68 subjects with cerebral palsy']","['BTX-A injection (Group 1) or radial extracorporeal shock wave therapy', 'radial extracorporeal shock wave therapy', 'botulinum toxin type', 'BTX-A injection', 'botulinum toxin type A (BTX-A) injection']",['plantar flexor muscle spasticity'],"[{'cui': 'C0007789', 'cui_str': 'Cerebral palsy'}]","[{'cui': 'C4060200', 'cui_str': 'Botulinum Toxin Type A Injection [Botox]'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C0442038', 'cui_str': 'Radial'}, {'cui': 'C1737238', 'cui_str': 'Extracorporeal shock wave therapy'}, {'cui': 'C0006050', 'cui_str': 'Botulinum Toxin Type A'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}]","[{'cui': 'C0230463', 'cui_str': 'Structure of sole of foot'}, {'cui': 'C0026838', 'cui_str': 'Spasticity'}]",68.0,0.0388298,BTX-A injection is not superior to radial extracorporeal shock wave therapy in the treatment of plantar flexor muscle spasticity in subjects with cerebral palsy.,"[{'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Vidal', 'Affiliation': 'Blanquerna School of Health Science, Ramon Llull University, Barcelona, Spain.'}, {'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Martí-Fàbregas', 'Affiliation': ''}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Canet', 'Affiliation': ''}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Roqué', 'Affiliation': ''}, {'ForeName': 'Antoni', 'Initials': 'A', 'LastName': 'Morral', 'Affiliation': ''}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Tur', 'Affiliation': ''}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Schmitz', 'Affiliation': ''}, {'ForeName': 'Mercè', 'Initials': 'M', 'LastName': 'Sitjà-Rabert', 'Affiliation': ''}]",Journal of rehabilitation medicine,['10.2340/16501977-2703'] 1761,32530412,The Effects of Intensive Versus Routine Treatment in Patients with Acute Kidney Injury.,"BACKGROUND In patients with acute kidney injury (AKI), specialized treatment-initiated in response to an early-warning system- may be beneficial compared with routine treatment. METHOD To explore effect estimators in a pilot trial (DRKS00010530), patients with AKI on regular wards of a university hospital were treated either in the usual way (control group) or more intensively (intervention group). The subjects were allotted randomly to the two treatment groups. The more intensive treatment consisted of an early warning system for a rise in the serum creatinine concentration, immediate consultation of a specialist, and the issuance of a patient kidney passport. The primary endpoint was recovery of renal function after AKI during the index hospitalization. Renal complications and process indicators were the secondary endpoints. RESULTS The proportion of patients whose renal function returned to baseline after AKI was 50% in the intervention group (N = 26) and 42% in the control group (N = 26) (odds ratio 1.4, 95% confidence interval [0.5; 4.0], p = 0.58). The calculated glomerular filtration rate went down, from hospital admission to discharge, by 3 mL/min/1.73 m2 (1st-3rd quartile: [6; -20]) in the intervention group and by 13 mL/min/1.73 m2 in the control group (1st-3rd quartile: [0; -25]; p = 0.09). Complications of AKI such as hyperkalemia, pulmonary edema, and renal acidosis were rarer in the intervention group (15% versus 39%; p = 0.03). In the intervention group, compared with the control group, the cause of AKI was identified more frequently (27% versus 4%; p = 0.05); drugs with relevance to the kidney were discontinued more frequently (65% versus 31%; p = 0.01); and the diagnosis of AKI was more frequently documented in the patient's chart (58% versus 37%; p = 0.03). CONCLUSION Specialized consultations supported by an early warning system for AKI seem to be beneficial for patients. The findings of this pilot trial should be verified in larger-scale randomized controlled trials.",2020,"The calculated glomerular filtration rate went down, from hospital admission to discharge, by 3 mL/min/1.73 m2 (1st-3rd quartile:","['patients with acute kidney injury (AKI', 'Patients with Acute Kidney Injury', 'patients with AKI on regular wards of a university hospital']",['Intensive Versus Routine Treatment'],"['cause of AKI', 'renal function', 'recovery of renal function', 'calculated glomerular filtration rate', 'diagnosis of AKI', 'Complications of AKI such as hyperkalemia, pulmonary edema, and renal acidosis']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}]","[{'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C0444686', 'cui_str': 'Calculated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0020461', 'cui_str': 'Hyperkalemia'}, {'cui': 'C0034063', 'cui_str': 'Pulmonary edema'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0001122', 'cui_str': 'Acidosis'}]",,0.061064,"The calculated glomerular filtration rate went down, from hospital admission to discharge, by 3 mL/min/1.73 m2 (1st-3rd quartile:","[{'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'Haase-Fielitz', 'Affiliation': 'Department of Cardiology, Brandenburg Heart Center, Immanuel Hospital, Bernau; Brandenburg Medical School Theodor Fontane; Institute of Social Medicine and Health Systems Research, Magdeburg University, Magdeburg; Department of Nephrology and Endocrinology, Ernst von Bergmann Hospital, Potsdam; Department of Urology and Pediatric Urology, Magdeburg University Hospital, Magdeburg; Department of Orthopedics and Trauma Surgery, Ameos Hospital, Schönebeck; Institute of Laboratory Medicine, Leipzig University Hospital, Leipzig; Diaverum Renal Care Center Am Neuen Garten, Potsdam; Faculty of Medicine, Otto-von-Guericke University of Magdeburg; Department of Nephrology, Essen University Hospital, Essen.'}, {'ForeName': 'Saban', 'Initials': 'S', 'LastName': 'Elitok', 'Affiliation': ''}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Schostak', 'Affiliation': ''}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Ernst', 'Affiliation': ''}, {'ForeName': 'Berend', 'Initials': 'B', 'LastName': 'Isermann', 'Affiliation': ''}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Albert', 'Affiliation': ''}, {'ForeName': 'Bernt-Peter', 'Initials': 'BP', 'LastName': 'Robra', 'Affiliation': ''}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Kribben', 'Affiliation': ''}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Haase', 'Affiliation': ''}]",Deutsches Arzteblatt international,['10.3238/arztebl.2020.0289'] 1762,32530436,A Mobile Game (Safe City) Designed to Promote Children's Safety Knowledge and Behaviors: Protocol for a Randomized Controlled Trial.,"BACKGROUND Children have high levels of curiosity and eagerness to explore. This makes them more vulnerable to danger and hazards, and they thus have a higher risk of injury. Safety education such as teaching safety rules and tips is vital to prevent children from injuries. Although game-based approaches have the potential to capture children's attention and sustain their interest in learning, whether these new instructional approaches are more effective than traditional approaches in delivering safety messages to children remains uncertain. OBJECTIVE The aim of this study is to test the effectiveness of a game-based intervention in promoting safety knowledge and behaviors among Hong Kong school children in Grades 4-6. It will also examine the potential effect of the game-based intervention on these children's functioning and psychosocial difficulties. METHODS This study comprises the development of a city-based role-playing game Safe City, where players are immersed as safety inspectors to prevent dangerous situations and promote safety behavior in a virtual city environment. The usability and acceptability tests will be conducted with children in Grades 4-6 who will trial the gameplay on a mobile phone. Adjustments will be made based on their feedback. A 4-week randomized controlled trial with children studying in Grades 4-6 in Hong Kong elementary schools will be conducted to assess the effectiveness of the Safe City game-based intervention. In this trial, 504 children will play Safe City, and 504 children will receive traditional instructional materials (electronic and printed safety information). The evaluation will be conducted using both child self-report and parent proxy-report data. Specifically, child safety knowledge and behaviors will be assessed by a questionnaire involving items on knowledge and behaviors, respectively, for home safety, road safety, and sport-related safety; child functioning will be assessed by PedsQL Generic Core Scales; and psychosocial difficulties will be assessed by the Strength and Difficulties Questionnaire. These questionnaires will be administered at 3 time points: before, 1 month, and 3 months after the intervention. Game usage statistics will also be reviewed. RESULTS This project was funded in September 2019. The design and development of the Safe City game are currently under way. Recruitment and data collection will begin from September 2020 and will continue up to March 1, 2021. Full analysis will be conducted after the end of the data collection period. CONCLUSIONS If the Safe City game is found to be an effective tool to deliver safety education, it could be used to promote safety in children in the community and upgraded to incorporate more health-related topics to support education and empowerment for the larger public. TRIAL REGISTRATION ClinicalTrials.gov NCT04096196; https://clinicaltrials.gov/ct2/show/NCT04096196. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID) PRR1-10.2196/17756.",2020,"If the Safe City game is found to be an effective tool to deliver safety education, it could be used to promote safety in children in the community and upgraded to incorporate more health-related topics to support education and empowerment for the larger public. ","['children studying in Grades 4-6 in Hong Kong elementary schools', 'children from injuries', 'Hong Kong school children in Grades 4-6', '504 children will play Safe City, and 504 children', 'children in Grades 4-6 who will trial the gameplay on a mobile phone']","['Safe City game-based intervention', 'traditional instructional materials (electronic and printed safety information', 'Mobile Game (Safe City', 'game-based intervention']","['safety knowledge and behaviors', 'usability and acceptability tests']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C3537125', 'cui_str': 'Common terminology criteria for adverse events grade 4'}, {'cui': 'C0019907', 'cui_str': 'Hong Kong'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0260267', 'cui_str': 'School child'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1136360', 'cui_str': 'Car Phone'}]","[{'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0033161', 'cui_str': 'Printing'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]",504.0,0.179091,"If the Safe City game is found to be an effective tool to deliver safety education, it could be used to promote safety in children in the community and upgraded to incorporate more health-related topics to support education and empowerment for the larger public. ","[{'ForeName': 'Rosa S', 'Initials': 'RS', 'LastName': 'Wong', 'Affiliation': 'Department of Paediatrics & Adolescent Medicine, The University of Hong Kong, Hong Kong, China (Hong Kong).'}, {'ForeName': 'Keith Ts', 'Initials': 'KT', 'LastName': 'Tung', 'Affiliation': 'Department of Paediatrics & Adolescent Medicine, The University of Hong Kong, Hong Kong, China (Hong Kong).'}, {'ForeName': 'Hiu Tung', 'Initials': 'HT', 'LastName': 'Wong', 'Affiliation': 'Department of Paediatrics & Adolescent Medicine, The University of Hong Kong, Hong Kong, China (Hong Kong).'}, {'ForeName': 'Frederick Kw', 'Initials': 'FK', 'LastName': 'Ho', 'Affiliation': 'Institute of Health and Wellbeing, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Hing Sang', 'Initials': 'HS', 'LastName': 'Wong', 'Affiliation': 'Department of Paediatrics & Adolescent Medicine, The University of Hong Kong, Hong Kong, China (Hong Kong).'}, {'ForeName': 'King-Wa', 'Initials': 'KW', 'LastName': 'Fu', 'Affiliation': 'Journalism and Media Studies Centre, University of Hong Kong, Hong Kong, China (Hong Kong).'}, {'ForeName': 'Ting Chuen', 'Initials': 'TC', 'LastName': 'Pong', 'Affiliation': 'Department of Computer Science & Engineering, The Hong Kong University of Science and Technology, Hong Kong, China (Hong Kong).'}, {'ForeName': 'Ko Ling', 'Initials': 'KL', 'LastName': 'Chan', 'Affiliation': 'Department of Applied Social Sciences, The Hong Kong Polytechnic University, Hong Kong, China (Hong Kong).'}, {'ForeName': 'Chun Bong', 'Initials': 'CB', 'LastName': 'Chow', 'Affiliation': 'Department of Paediatrics & Adolescent Medicine, The University of Hong Kong, Hong Kong, China (Hong Kong).'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Ip', 'Affiliation': 'Department of Paediatrics & Adolescent Medicine, The University of Hong Kong, Hong Kong, China (Hong Kong).'}]",JMIR research protocols,['10.2196/17756'] 1763,32526490,Creativity on tap 2: Investigating dose effects of alcohol on cognitive control and creative cognition.,"This preregistered study aimed to replicate and extend research on the role of cognitive control in creative cognition by examining dose effects of alcohol in a randomized controlled trial. A sample of 125 participants was randomly assigned to three experimental groups, either drinking alcoholic beer (BAC = 0.03 or 0.06) or drinking non-alcoholic beer (placebo-control group). Before and after the alcohol intervention, participants completed two tests of cognitive control and two established creative thinking tasks. A BAC of 0.06 led to an impairment of verbal fluency, while working memory performance was unaffected at both alcohol levels. Alcohol had no facilitative or detrimental effects on creative thinking performance, neither in terms of RAT performance, divergent thinking fluency or divergent thinking creativity. These results indicate that moderate alcohol levels have dose-dependent, selective effects on cognitive control, and that minor impairments of cognitive control do not generally increase or attenuate creative thinking performance.",2020,"Alcohol had no facilitative or detrimental effects on creative thinking performance, neither in terms of RAT performance, divergent thinking fluency or divergent thinking creativity.",['A sample of 125 participants'],"['drinking alcoholic beer (BAC\xa0=\xa00.03 or 0.06) or drinking non-alcoholic beer (placebo-control group', 'alcohol', 'cognitive control and two established creative thinking tasks']","['creative thinking performance', 'verbal fluency, while working memory performance', 'RAT performance, divergent thinking fluency or divergent thinking creativity', 'cognitive control and creative cognition']","[{'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C4319551', 'cui_str': '125'}]","[{'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0687725', 'cui_str': 'Problem drinker'}, {'cui': 'C0004922', 'cui_str': 'Beer'}, {'cui': 'C0004599', 'cui_str': 'Bacitracin'}, {'cui': 'C4517402', 'cui_str': '0.03'}, {'cui': 'C4517412', 'cui_str': '0.06'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0443211', 'cui_str': 'Established'}, {'cui': 'C0010297', 'cui_str': 'Creative thought'}]","[{'cui': 'C0010297', 'cui_str': 'Creative thought'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}]",125.0,0.0319793,"Alcohol had no facilitative or detrimental effects on creative thinking performance, neither in terms of RAT performance, divergent thinking fluency or divergent thinking creativity.","[{'ForeName': 'Mathias', 'Initials': 'M', 'LastName': 'Benedek', 'Affiliation': 'Institute of Psychology, University of Graz, Austria. Electronic address: mathias.benedek@uni-graz.at.'}, {'ForeName': 'Lena', 'Initials': 'L', 'LastName': 'Zöhrer', 'Affiliation': 'Institute of Psychology, University of Graz, Austria.'}]",Consciousness and cognition,['10.1016/j.concog.2020.102972'] 1764,32526502,The effect of rumination and distraction on auditory hallucinatory experiences: An analogue experimental study.,"BACKGROUND AND OBJECTIVES The cognitive model of voices suggests that negative appraisals of hallucinatory experiences result in responses, such as rumination, which maintain voice-hearing. Our principal aim was to investigate the effect of rumination on the frequency of voice-hearing. METHODS A two-group randomised experimental design was employed using a non-clinical sample. A total of 106 participants completed baseline measures of trait rumination, hallucination-proneness, mood and state negative affect, and were presented with a voice-hearing paradigm. False feedback designed to cause a negative interpretation of auditory intrusions was provided and participants were randomly allocated to either a distraction or rumination condition. Participants performed the auditory task for a second time, and the total number of false alarms and distress scores were compared between groups. RESULTS A Mann-Whitney U test revealed that the manipulation of rumination was successful (p = 0.007). We did not detect a statistically significant difference between the distraction and rumination groups for total false alarms (p = 0.282) or distress (p = 0.387) scores. LIMITATIONS Findings largely relate to a female undergraduate psychology sample. CONCLUSION Results of this non-clinical study do not support the hypothesis that rumination leads to an increase in the frequency of voice-hearing on a laboratory task.",2020,"We did not detect a statistically significant difference between the distraction and rumination groups for total false alarms (p = 0.282) or distress (p = 0.387) scores. ","['106 participants completed baseline measures of trait rumination, hallucination-proneness, mood and state negative affect, and were presented with a voice-hearing paradigm', 'auditory hallucinatory experiences', 'female undergraduate psychology sample']","['distraction or rumination condition', 'rumination and distraction']","['distress', 'auditory task', 'total number of false alarms and distress scores', 'frequency of voice-hearing']","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0154575', 'cui_str': 'Rumination disorder'}, {'cui': 'C0018524', 'cui_str': 'Hallucinations'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0033909', 'cui_str': 'Psychology'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}]","[{'cui': 'C0150189', 'cui_str': 'Distraction training'}, {'cui': 'C0154575', 'cui_str': 'Rumination disorder'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205557', 'cui_str': 'False positive'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}]",106.0,0.0413272,"We did not detect a statistically significant difference between the distraction and rumination groups for total false alarms (p = 0.282) or distress (p = 0.387) scores. ","[{'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Anderson', 'Affiliation': 'Division of Psychology and Mental Health, School of Health Sciences, Faculty of Biology, Medicine and Health, Manchester Academic Health Sciences, The University of Manchester, Manchester, United Kingdom.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Hartley', 'Affiliation': 'Division of Psychology and Mental Health, School of Health Sciences, Faculty of Biology, Medicine and Health, Manchester Academic Health Sciences, The University of Manchester, Manchester, United Kingdom; Pennine Care NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Morrison', 'Affiliation': 'Division of Psychology and Mental Health, School of Health Sciences, Faculty of Biology, Medicine and Health, Manchester Academic Health Sciences, The University of Manchester, Manchester, United Kingdom; Greater Manchester Mental Health NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Bucci', 'Affiliation': 'Division of Psychology and Mental Health, School of Health Sciences, Faculty of Biology, Medicine and Health, Manchester Academic Health Sciences, The University of Manchester, Manchester, United Kingdom; Greater Manchester Mental Health NHS Foundation Trust, Manchester, UK. Electronic address: sandra.bucci@manchester.ac.uk.'}]",Journal of behavior therapy and experimental psychiatry,['10.1016/j.jbtep.2020.101592'] 1765,32526534,The RICH LIFE Project: A cluster randomized pragmatic trial comparing the effectiveness of health system only vs. health system Plus a collaborative/stepped care intervention to reduce hypertension disparities.,"Disparities in the control of hypertension and other cardiovascular disease risk factors are well-documented in the United States, even among patients seen regularly in the healthcare system. Few existing approaches explicitly address disparities in hypertension care and control. This paper describes the RICH LIFE Project (Reducing Inequities in Care of Hypertension: Lifestyle Improvement for Everyone) design. METHODS RICH LIFE is a two-arm, cluster-randomized trial, comparing the effectiveness of enhanced standard of care, ""Standard of Care Plus"" (SCP), to a multi-level intervention, ""Collaborative Care/Stepped Care"" (CC/SC), for improving blood pressure (BP) control and patient activation and reducing disparities in BP control among 1890 adults with uncontrolled hypertension and at least one other cardiovascular disease risk factor treated at 30 primary care practices in Maryland and Pennsylvania. Fifteen practices randomized to the SCP arm receive standardized BP measurement training; race/ethnicity-specific audit and feedback of BP control rates; and quarterly webinars in management practices, quality improvement and disparities reduction. Fifteen practices in the CC/SC arm receive the SCP interventions plus implementation of the collaborative care model with stepped-care components (community health worker referrals and virtual specialist-panel consults). The primary clinical outcome is BP control (<140/90 mm Hg) at 12 months. The primary patient-reported outcome is change from baseline in self-reported patient activation at 12 months. DISCUSSION This study will provide knowledge about the feasibility of leveraging existing resources in routine primary care and potential benefits of adding supportive community-facing roles to improve hypertension care and reduce disparities. TRIAL REGISTRATION Clinicaltrials.govNCT02674464.",2020,Fifteen practices in the CC/SC arm receive the SCP interventions plus implementation of the collaborative care model with stepped-care components (community health worker referrals and virtual specialist-panel consults).,['1890 adults with uncontrolled hypertension and at least one other cardiovascular disease risk factor treated at 30 primary care practices in Maryland and Pennsylvania'],"['RICH LIFE Project', 'enhanced standard of care, ""Standard of Care Plus"" (SCP), to a multi-level intervention, ""Collaborative Care/Stepped Care"" (CC/SC', 'SCP arm receive standardized BP measurement training; race/ethnicity-specific audit and feedback of BP control rates', 'health system only vs health system plus a collaborative/stepped care intervention']","['blood pressure (BP) control and patient activation', 'hypertension disparities', 'BP control']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1868885', 'cui_str': 'Uncontrolled hypertension'}, {'cui': 'C0348668', 'cui_str': 'Other and unspecified disorders of circulatory system'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0024858', 'cui_str': 'Maryland'}, {'cui': 'C0030853', 'cui_str': 'Pennsylvania'}]","[{'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0016538', 'cui_str': 'Projections and Predictions'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0005824', 'cui_str': 'Blood pressure taking'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0034510', 'cui_str': 'Racial group'}, {'cui': 'C0015031', 'cui_str': 'Ethnic group'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0450985', 'cui_str': 'Alcohol use disorders identification test'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C3853034', 'cui_str': 'Patient Activation'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}]",1890.0,0.09569,Fifteen practices in the CC/SC arm receive the SCP interventions plus implementation of the collaborative care model with stepped-care components (community health worker referrals and virtual specialist-panel consults).,"[{'ForeName': 'Lisa A', 'Initials': 'LA', 'LastName': 'Cooper', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD, USA; Johns Hopkins Center for Health Equity, Johns Hopkins University, Baltimore, MD, USA; The Welch Center for Prevention, Epidemiology and Clinical Research, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA; Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA. Electronic address: lisa.cooper@jhmi.edu.'}, {'ForeName': 'Jill A', 'Initials': 'JA', 'LastName': 'Marsteller', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD, USA; Johns Hopkins Center for Health Equity, Johns Hopkins University, Baltimore, MD, USA; The Welch Center for Prevention, Epidemiology and Clinical Research, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA; Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA; Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Kathryn A', 'Initials': 'KA', 'LastName': 'Carson', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD, USA; Johns Hopkins Center for Health Equity, Johns Hopkins University, Baltimore, MD, USA; The Welch Center for Prevention, Epidemiology and Clinical Research, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA; Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Katherine B', 'Initials': 'KB', 'LastName': 'Dietz', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD, USA; Johns Hopkins Center for Health Equity, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Romsai T', 'Initials': 'RT', 'LastName': 'Boonyasai', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD, USA; Johns Hopkins Center for Health Equity, Johns Hopkins University, Baltimore, MD, USA; Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Alvarez', 'Affiliation': 'Johns Hopkins Center for Health Equity, Johns Hopkins University, Baltimore, MD, USA; John Hopkins University School of Nursing, Baltimore, MD, USA.'}, {'ForeName': 'Chidinma A', 'Initials': 'CA', 'LastName': 'Ibe', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD, USA; Johns Hopkins Center for Health Equity, Johns Hopkins University, Baltimore, MD, USA; Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Deidra C', 'Initials': 'DC', 'LastName': 'Crews', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD, USA; Johns Hopkins Center for Health Equity, Johns Hopkins University, Baltimore, MD, USA; The Welch Center for Prevention, Epidemiology and Clinical Research, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Hsin-Chieh', 'Initials': 'HC', 'LastName': 'Yeh', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD, USA; Johns Hopkins Center for Health Equity, Johns Hopkins University, Baltimore, MD, USA; The Welch Center for Prevention, Epidemiology and Clinical Research, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA; Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Edgar R', 'Initials': 'ER', 'LastName': 'Miller', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD, USA; Johns Hopkins Center for Health Equity, Johns Hopkins University, Baltimore, MD, USA; The Welch Center for Prevention, Epidemiology and Clinical Research, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA; Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Cheryl R', 'Initials': 'CR', 'LastName': 'Dennison-Himmelfarb', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD, USA; Johns Hopkins Center for Health Equity, Johns Hopkins University, Baltimore, MD, USA; Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA; John Hopkins University School of Nursing, Baltimore, MD, USA.'}, {'ForeName': 'Lisa H', 'Initials': 'LH', 'LastName': 'Lubomski', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD, USA; Johns Hopkins Center for Health Equity, Johns Hopkins University, Baltimore, MD, USA; Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Tanjala S', 'Initials': 'TS', 'LastName': 'Purnell', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD, USA; Johns Hopkins Center for Health Equity, Johns Hopkins University, Baltimore, MD, USA; The Welch Center for Prevention, Epidemiology and Clinical Research, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA; Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': 'Felicia', 'Initials': 'F', 'LastName': 'Hill-Briggs', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD, USA; Johns Hopkins Center for Health Equity, Johns Hopkins University, Baltimore, MD, USA; The Welch Center for Prevention, Epidemiology and Clinical Research, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA; Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA; John Hopkins University School of Nursing, Baltimore, MD, USA.'}, {'ForeName': 'Nae-Yuh', 'Initials': 'NY', 'LastName': 'Wang', 'Affiliation': 'Johns Hopkins University School of Medicine, Baltimore, MD, USA; Johns Hopkins Center for Health Equity, Johns Hopkins University, Baltimore, MD, USA; The Welch Center for Prevention, Epidemiology and Clinical Research, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA; Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American heart journal,['10.1016/j.ahj.2020.05.001'] 1766,32527365,Low male partner attendance after syphilis screening in pregnant women leads to worse birth outcomes: the Syphilis Treatment of Partners (STOP) randomised control trial.,"Background Maternal syphilis causes poor birth outcomes, including congenital syphilis. Testing and treatment of partners prevents reinfection, but strategies to improve partner attendance are failing. The aim of this study was to determine the effectiveness of three partner notification strategies. METHODS Pregnant women with a positive point-of-care treponemal test at three antenatal clinics (ANCs) in Kampala, Uganda, were randomised 1:1:1 to receive either notification slips (NS; standard of care), NS and a text messages (SMS) or NS and telephone calls. The primary outcome was the proportion of partners who attended the ANC and were treated for syphilis. RESULTS Between 2015 and 2016, 17130 pregnant women were screened; 601 (3.5%) had a positive treponemal result, and 442 were enrolled in the study. Only 81 of 442 partners (18.3%; 23/152 (15.1%), 31/144 (21.5%) and 27/146 (18.5%) in the NS only, NS + SMS and NS + telephone call groups respectively) attended an ANC for follow-up; there were no significant differences between the groups. Twelve per cent of women attended the ANC with their male partner, and this proportion increased over time. Partner non-treatment was independently associated with adverse birth outcomes (odds ratio 2.75; 95% confidence interval 2.36-3.21; P < 0.001). CONCLUSIONS Only 18.3% of partners of pregnant women who tested positive for syphilis received treatment. Female partners of non-attendant men had worse birth outcomes. Encouraging men to accompany women to the ANC and testing both may address the urgent need to treat partners of pregnant women in sub-Saharan Africa to reduce poor fetal outcomes.",2020,Partner non-treatment was independently associated with adverse birth outcomes (odds ratio 2.75; 95% confidence interval 2.36-3.21; P < 0.001). ,"['17130 pregnant women were screened; 601 (3.5%) had a positive treponemal result, and 442 were enrolled in the study', 'Pregnant women with a positive point-of-care treponemal test at three antenatal clinics (ANCs) in Kampala, Uganda', 'Female partners of non-attendant men had worse birth outcomes', 'Low male partner attendance after syphilis screening in pregnant women', 'Results: Between 2015 and 2016', 'pregnant women who tested positive for syphilis received treatment']","['notification slips (NS; standard of care), NS and a text messages (SMS) or NS and telephone calls']","['proportion of partners who attended the ANC', 'adverse birth outcomes']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C3844010', 'cui_str': '3.5'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0282664', 'cui_str': 'Point-of-Care'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1274027', 'cui_str': 'Antenatal clinic'}, {'cui': 'C0041573', 'cui_str': 'Uganda'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C1286282', 'cui_str': 'Birth outcome'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C0039128', 'cui_str': 'Syphilis'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0422202', 'cui_str': 'Notifications'}, {'cui': 'C0337209', 'cui_str': 'Slipping'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C1720420', 'cui_str': 'Call'}]","[{'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0948762', 'cui_str': 'Absolute neutrophil count'}, {'cui': 'C1286282', 'cui_str': 'Birth outcome'}]",17130.0,0.183705,Partner non-treatment was independently associated with adverse birth outcomes (odds ratio 2.75; 95% confidence interval 2.36-3.21; P < 0.001). ,"[{'ForeName': 'Rosalind', 'Initials': 'R', 'LastName': 'Parkes-Ratanshi', 'Affiliation': 'Infectious Diseases Institute, Makerere University College of Health Sciences, PO Box 22418, Kampala, Uganda; and Institute of Public Health, University of Cambridge, Forvie Site, Cambridge CB2 0SR, UK; and Corresponding author. Email: rp549@medschl.cam.ac.uk.'}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Mbazira Kimeze', 'Affiliation': 'Infectious Diseases Institute, Makerere University College of Health Sciences, PO Box 22418, Kampala, Uganda.'}, {'ForeName': 'Edith', 'Initials': 'E', 'LastName': 'Nakku-Joloba', 'Affiliation': 'School of Public Health, Makerere University College of Health Sciences, PO Box 7072, Kampala, Uganda.'}, {'ForeName': 'Matthew M', 'Initials': 'MM', 'LastName': 'Hamill', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, Johns Hopkins University School of Medicine, 1830 E. Monument Street, Room 8031, Baltimore, MD 21287, USA.'}, {'ForeName': 'Mariam', 'Initials': 'M', 'LastName': 'Namawejje', 'Affiliation': 'Infectious Diseases Institute, Makerere University College of Health Sciences, PO Box 22418, Kampala, Uganda.'}, {'ForeName': 'Agnes', 'Initials': 'A', 'LastName': 'Kiragga', 'Affiliation': 'Infectious Diseases Institute, Makerere University College of Health Sciences, PO Box 22418, Kampala, Uganda.'}, {'ForeName': 'Josaphat', 'Initials': 'J', 'LastName': 'Kayogoza Byamugisha', 'Affiliation': 'School of Medicine, Makerere University College of Health Sciences, PO Box 7072, Kampala, Uganda.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Rompalo', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, Johns Hopkins University School of Medicine, 1830 E. Monument Street, Room 8031, Baltimore, MD 21287, USA.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Gaydos', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, Johns Hopkins University School of Medicine, 1830 E. Monument Street, Room 8031, Baltimore, MD 21287, USA.'}, {'ForeName': 'Yukari C', 'Initials': 'YC', 'LastName': 'Manabe', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, Johns Hopkins University School of Medicine, 1830 E. Monument Street, Room 8031, Baltimore, MD 21287, USA.'}]",Sexual health,['10.1071/SH19092'] 1767,32531816,Formulation and efficacy evaluation of the safe and efficient moisturizing snow mushroom hand sanitizer.,"OBJECTIVES Snow fungus or snow mushroom or white jelly mushroom (Tremella fuciformis), the edible mushroom, was formulated into hand sanitizer in form of moisturizing alcohol-based hand rub (ABHR) gel. METHODS The stable base ABHRs were developed. The preferred bases were incorporated with various concentrations of snow mushroom extract. The stable and preferred snow mushroom ABHR was moisturizing and sanitizing efficacies evaluated in 20 human volunteers in comparison with its placebo. RESULTS The stable hand sanitizer gel bases containing 66.5% of ethanol and 0.3% of triclosan were developed and incorporated with the extract of snow mushroom polysaccharide. Of which, the preparations containing 10% of snow mushroom and 0.3% of gelling agent gained the highest preferences as assessed in 20 Thai volunteers. The snow mushroom hand sanitizer was proved to be none irritated in the same group of the volunteers as was the placebo. The snow mushroom gel significantly (P < .05) moist the skin better than the placebo at all time of the interval assessment until the end of the study at 180 minutes. The hand sanitizers were confirmed on their anti-septic, at which the efficacies of the active and placebo ABHR were comparable (P = .90). CONCLUSIONS Snow mushroom ABHR gel with its confirmed moisturizing and sanitizing efficacies is presented. It is meetings with the recommendation on hand hygienic improvement to combat the infections of diseases spreading. The preparation can be frequency applied with its proved skin hydrating efficacy co-contributes in a good condition of hand hygiene.",2020,The snow mushroom gel significantly (P < 0.05) moist the skin better than the placebo at all time of the interval assessment until the end of the study at 180 min.,"['20 human volunteers in a comparison with its placebo', '20 Thai volunteers']","['ethanol and 0.3% triclosan', 'Snow fungus or snow mushroom or white jelly mushroom (Tremella fuciformis), the edible mushroom, was formulated into hand sanitizer in form of moisturizing alcohol-based hand rubs (ABHR) gel', 'placebo']",[],"[{'cui': 'C0020155', 'cui_str': 'Human Volunteers'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0039724', 'cui_str': 'Thai language'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C4068885', 'cui_str': '0.3'}, {'cui': 'C0040958', 'cui_str': 'Triclosan'}, {'cui': 'C0009170', 'cui_str': 'Cocaine'}, {'cui': 'C0016832', 'cui_str': 'Fungi'}, {'cui': 'C0001774', 'cui_str': 'Order Agaricales'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C1330330', 'cui_str': 'Hand Antiseptics'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],20.0,0.031813,The snow mushroom gel significantly (P < 0.05) moist the skin better than the placebo at all time of the interval assessment until the end of the study at 180 min.,"[{'ForeName': 'Nattaya', 'Initials': 'N', 'LastName': 'Lourith', 'Affiliation': 'School of Cosmetic Science, Mae Fah Luang University, Chiang Rai, Thailand.'}, {'ForeName': 'Sathaporn', 'Initials': 'S', 'LastName': 'Pungprom', 'Affiliation': 'School of Cosmetic Science, Mae Fah Luang University, Chiang Rai, Thailand.'}, {'ForeName': 'Mayuree', 'Initials': 'M', 'LastName': 'Kanlayavattanakul', 'Affiliation': 'School of Cosmetic Science, Mae Fah Luang University, Chiang Rai, Thailand.'}]",Journal of cosmetic dermatology,['10.1111/jocd.13543'] 1768,32534120,Effect of traditional Chinese medicine formula GeGen decoction on primary dysmenorrhea: A randomized controlled trial study.,"ETHNOPHARMACOLOGICAL RELEVANCE GeGen Decoction, a well-known Chinese herbal formula, is widely used in China and other Asian countries to treat gynecological diseases, including primary dysmenorrhea. Pharmacological studies have confirmed that GeGen Decoction is able to inhibit spasmodic contractions of the uterus in vivo and in vitro. AIM OF THE STUDY The objective of this study is to examine the efficacy and safety of GeGen Decoction on primary dysmenorrheic patients. METHODS This was a randomized, double-blinded, placebo-controlled trial. GeGen Decoction or placebo was administered a week before the expected start of each cycle for three consecutive menstrual periods. Between-group differences in pain intensity were detected by visual analogue scale (VAS). In addition, serum levels of arginine vasopressin (AVP) and estrogen (E) were examined by enzyme-linked immunosorbent assay. Metabolomic analysis was further used to evaluate the influence of GeGen Decoction on the metabolomics of primary dysmenorrheic patients. RESULTS A total of 71 primary dysmenorrheic women were recruited and 30 participants met the criteria were randomized into GeGen Decoction or placebo group. After three consecutive menstrual cycles' treatments, the VAS score of the GeGen Decoction group was significantly lower than that of the placebo group. Both serum levels of AVP and E decreased after GeGen Decoction administration, while the placebo seemed to have little effect on either of the index. Moreover, after GeGen Decoction treatment, seven important metabolites were identified by metabolomic analysis compared to the placebo group. No abnormalities in blood biochemical and routine physical examination pre and post GeGen Decoction intervention were observed. CONCLUSIONS GeGen Decoction can remarkably relieve the severity of menstrual pain without obvious adverse effects. Its therapeutic effect on primary dysmenorrhea might be related to the regulation of pituitary hypothalamic ovarian hormones, and interfering with the metabolic change.",2020,"After three consecutive menstrual cycles' treatment, the VAS score of the GeGen Decoction group was significantly lower than that of the placebo group.","['primary dysmenorrhea', 'primary dysmenorrheic patients', '71 primary dysmenorrheic women were recruited and 30 participants met the criteria']","['GeGen Decoction', 'traditional Chinese medicine formula GeGen decoction', 'GeGen Decoction or placebo', 'placebo']","['VAS score', 'pain intensity', 'blood biochemical and routine physical examination pre and post GeGen Decoction intervention', 'visual analogue scale (VAS', 'serum levels of arginine vasopressin (AVP) and estrogen (E', 'serum levels of AVP and E', 'efficacy and safety', 'severity of menstrual pain']","[{'cui': 'C0149875', 'cui_str': 'Primary dysmenorrhea'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0025124', 'cui_str': 'Traditional Chinese Medicine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0003779', 'cui_str': 'Argipressin'}, {'cui': 'C0014939', 'cui_str': 'Estrogens'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0013390', 'cui_str': 'Dysmenorrhea'}]",71.0,0.369829,"After three consecutive menstrual cycles' treatment, the VAS score of the GeGen Decoction group was significantly lower than that of the placebo group.","[{'ForeName': 'Chengzhi', 'Initials': 'C', 'LastName': 'Chai', 'Affiliation': 'Jiangsu Provincial Key Laboratory for TCM Evaluation and Translational Development, School of Traditional Chinese Pharmacy, China Pharmaceutical University, Nanjing, Jiangsu Province, 211198, PR China.'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Hong', 'Affiliation': 'Jiangsu Provincial Key Laboratory for TCM Evaluation and Translational Development, School of Traditional Chinese Pharmacy, China Pharmaceutical University, Nanjing, Jiangsu Province, 211198, PR China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Yan', 'Affiliation': 'Shanxi University, Taiyuan, Shanxi Province, PR China.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': 'Jiangsu Provincial Key Laboratory for TCM Evaluation and Translational Development, School of Traditional Chinese Pharmacy, China Pharmaceutical University, Nanjing, Jiangsu Province, 211198, PR China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Zong', 'Affiliation': 'Hospital Affiliated to Shanxi University of Traditional Chinese Medicine, Taiyuan, Shanxi Province, PR China.'}, {'ForeName': 'Changsong', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'Department of Traditional Chinese Medicine, Zhongda Hospital, Southeast University, Nanjing, Jiangsu Province, PR China.'}, {'ForeName': 'Zhigang', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'Department of Traditional Chinese Medicine, Zhongda Hospital, Southeast University, Nanjing, Jiangsu Province, PR China. Electronic address: liuzhigang729@seu.edu.cn.'}, {'ForeName': 'Boyang', 'Initials': 'B', 'LastName': 'Yu', 'Affiliation': 'Jiangsu Provincial Key Laboratory for TCM Evaluation and Translational Development, School of Traditional Chinese Pharmacy, China Pharmaceutical University, Nanjing, Jiangsu Province, 211198, PR China. Electronic address: boyangyu59@163.com.'}]",Journal of ethnopharmacology,['10.1016/j.jep.2020.113053'] 1769,32534175,"Three novel prevention, diagnostic, and treatment options for COVID-19 urgently necessitating controlled randomized trials.","PURPOSE Asymptomatic or minimally symptomatic infection with COVID-19 can result in silent transmission to large numbers of individuals, resulting in expansion of the pandemic with a global increase in morbidity and mortality. New ways of screening the general population for COVID-19 are urgently needed along with novel effective prevention and treatment strategies. HYPOTHESIS A hypothetical three-part prevention, diagnostic, and treatment approach based on an up-to-date scientific literature review for COVID-19 is proposed. Regarding diagnosis, a validated screening questionnaire and digital app for COVID-19 could help identify individuals who are at risk of transmitting the disease, as well as those at highest risk for poor clinical outcomes. Global implementation and online tracking of vital signs and scored questionnaires that are statistically validated would help health authorities properly allocate essential health care resources to test and isolate those at highest risk for transmission and poor outcomes. Second, regarding prevention, no validated protocols except for physical distancing, hand washing, and isolation exist, and recently ivermectin has been published to have anti-viral properties against COVID-19. A randomized trial of ivermectin, and/or nutraceuticals that have been published to support immune function including glutathione, vitamin C, zinc, and immunomodulatory supplements (3,6 Beta glucan) could be beneficial in preventing transmission or lessening symptomatology but requires statistical validation. Third, concerning treatment, COVID-19 induced inflammation and ""cytokine storm syndrome"" with hemophagocytic lymphohistiocytosis (HLH)/Macrophage Activation Syndrome (MAS) have resulted in extreme morbidity and mortality in those with certain comorbidities, secondary to ""acute respiratory distress syndrome"" (ARDS) and multiorgan dysfunction with disseminated intravascular coagulation (DIC). Deficiency in red blood cell, serum and alveolar glutathione has been published in the medical literature for ARDS, as well as viral and bacterial pneumonias, resulting from increased levels of free radical/oxidative stress. A randomized controlled trial of blocking NF-κB and cytokine formation using glutathione precursors (N-acetyl-cysteine [NAC] and alpha lipoic acid) and PO/IV glutathione with associated anti-viral effects should be performed, along with an evaluation of Nrf2 activators (curcumin, sulforaphane glucosinolate) which have been scientifically proven to lower inflammation. Since high mortality rates from sepsis induced DIC due to COVID-19 infection has also been associated with thrombotic events and elevated levels of D-dimer, randomized controlled trials of using anticoagulant therapy with heparin is urgently required. This is especially important in patients on ventilators who have met certain sepsis induced coagulopathy (SIC) criteria. The use of acetazolamide with or without sildenafil also needs to be explored with or without heparin, since increased oxygen delivery to vital organs through prevention of thrombosis/pulmonary emboli along with carbonic anhydrase inhibition may help increase oxygenation and prevent adverse clinical outcomes. CONCLUSION AND IMPLICATIONS A three-part prevention, diagnostic, and treatment plan is proposed for addressing the severe complications of COVID-19. Digital monitoring of symptoms to clinically diagnose early exposure and response to treatment; prevention with ivermectin as well as nutritional therapies that support a healthy immune response; treatment with anti-inflammatory therapies that block NF-κB and activate Nrf2 pathways, as well as novel therapies that address COVID-19 pneumonia and ARDS with DIC including anticoagulation and/or novel respiratory therapies with or without acetazolamide and sildenafil. These three broad-based interventions urgently need to be subjected to randomized, controlled trials.",2020,"New ways of screening the general population for COVID-19 are urgently needed along with novel effective prevention and treatment strategies. ",['patients on ventilators who have met certain sepsis induced coagulopathy (SIC) criteria'],"['ivermectin', 'acetazolamide and sildenafil', 'heparin', 'hemophagocytic lymphohistiocytosis (HLH)/Macrophage Activation Syndrome (MAS', 'acetazolamide with or without sildenafil', 'blocking NF-κB and cytokine formation using glutathione precursors (N-acetyl-cysteine [NAC] and alpha lipoic acid) and PO/IV glutathione']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2603364', 'cui_str': 'On ventilator'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0205423', 'cui_str': 'Certain'}, {'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0005779', 'cui_str': 'Blood coagulation disorder'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0022322', 'cui_str': 'Ivermectin'}, {'cui': 'C0000981', 'cui_str': 'Acetazolamide'}, {'cui': 'C0529793', 'cui_str': 'sildenafil'}, {'cui': 'C0019134', 'cui_str': 'heparin'}, {'cui': 'C0024291', 'cui_str': 'Hemophagocytic lymphohistiocytosis'}, {'cui': 'C1868709', 'cui_str': 'Activation syndrome'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0017817', 'cui_str': 'Glutathione'}, {'cui': 'C0001047', 'cui_str': 'Acetylcysteine'}, {'cui': 'C0023791', 'cui_str': 'thioctic acid'}]",[],,0.0711722,"New ways of screening the general population for COVID-19 are urgently needed along with novel effective prevention and treatment strategies. ","[{'ForeName': 'Richard I', 'Initials': 'RI', 'LastName': 'Horowitz', 'Affiliation': 'HHS Babesia and Tickborne Pathogen Subcommittee, Washington, D.C. 20201, USA; Hudson Valley Healing Arts Center, 4232 Albany Post Road, Hyde Park, NY 12538, USA. Electronic address: medical@hvhac.com.'}, {'ForeName': 'Phyllis R', 'Initials': 'PR', 'LastName': 'Freeman', 'Affiliation': 'Hudson Valley Healing Arts Center, 4232 Albany Post Road, Hyde Park, NY 12538, USA.'}]",Medical hypotheses,['10.1016/j.mehy.2020.109851'] 1770,32534221,The three-year effect of a single zoledronate infusion on bone mineral density and bone turnover markers following denosumab discontinuation in women with postmenopausal osteoporosis.,"INTRODUCTION In women with postmenopausal osteoporosis denosumab discontinuation is associated with rapid bone loss that could be potentially prevented by a single zoledronate infusion for two years. The longer-term effects, however, of zoledronate treatment are unknown. We aimed to study the effect of a single zoledronate infusion during the third year following denosumab discontinuation, in initially treatment-naive postmenopausal women who became osteopenic after 2.4 ± 0.2 years of denosumab therapy. METHODS We report the 1-year follow-up results of a single arm observational extension of a previously reported 2-year multicenter prospective randomized clinical trial. The primary endpoint of this extension was the change in lumbar spine bone mineral density (LS-BMD); secondary endpoints were changes in femoral neck (FN)-BMD and markers of bone turnover (BTM) during the 3rd year from the zoledronate infusion. Changes are presented as mean and SEM. RESULTS LS-BMD did not change significantly at year 3 compared to year 2 (-1.35 ± 1.1%, p = 1.00) and compared to baseline (-1.96 ± 1.44%, p = 1.00). FN-BMD values did not change while serum P1NP values decreased and CTX values remained unchanged during the third-year of the follow-up. In 4 of the 23 studied women BMD values returned to the osteoporotic range at 3 years. CONCLUSIONS A single i.v. infusion of zoledronate 5 mg, given 6 months after the last injection of denosumab therapy maintains for three years BMD gains in the majority of patients previously treated with denosumab for an approximate period of 2.5 years. Follow-up of patients is, however, recommended because about one-fifth of treated women will require additional antiosteoporotic treatment.",2020,FN-BMD values did not change while serum P1NP values decreased and CTX values remained unchanged during the third-year of the follow-up.,"['women with postmenopausal osteoporosis', 'initially treatment-naive postmenopausal women who became osteopenic after 2.4\u202f±\u202f0.2\u202fyears of denosumab therapy']","['single zoledronate infusion', 'zoledronate infusion', 'denosumab', 'zoledronate', 'denosumab discontinuation']","['CTX values', 'femoral neck (FN)-BMD and markers of bone turnover (BTM', 'FN-BMD values', 'lumbar spine bone mineral density (LS-BMD', 'bone mineral density and bone turnover markers', 'LS-BMD']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0029458', 'cui_str': 'Postmenopausal osteoporosis'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C4517631', 'cui_str': '2.4'}, {'cui': 'C4517436', 'cui_str': '0.2'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3839270', 'cui_str': 'Denosumab therapy'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0392938', 'cui_str': 'Zoledronate'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C1690432', 'cui_str': 'denosumab'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}]","[{'cui': 'C0010377', 'cui_str': 'Crotoxin'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0015815', 'cui_str': 'Structure of neck of femur'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0085268', 'cui_str': 'Bone remodeling'}, {'cui': 'C0024091', 'cui_str': 'Bone structure of lumbar vertebra'}]",23.0,0.0926873,FN-BMD values did not change while serum P1NP values decreased and CTX values remained unchanged during the third-year of the follow-up.,"[{'ForeName': 'Polyzois', 'Initials': 'P', 'LastName': 'Makras', 'Affiliation': 'Department of Endocrinology and Diabetes and Department of Medical Research, 251 Hellenic Air Force & VA General Hospital, Athens, Greece.'}, {'ForeName': 'Socrates E', 'Initials': 'SE', 'LastName': 'Papapoulos', 'Affiliation': 'Center for Bone Quality, Department of Internal Medicine, Section Endocrinology, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Stergios A', 'Initials': 'SA', 'LastName': 'Polyzos', 'Affiliation': 'First Laboratory of Pharmacology, School of Medicine, Aristotle University of Thessaloniki, Thessaloniki, Greece.'}, {'ForeName': 'Natasha M', 'Initials': 'NM', 'LastName': 'Appelman-Dijkstra', 'Affiliation': 'Center for Bone Quality, Department of Internal Medicine, Section Endocrinology, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'Athanasios D', 'Initials': 'AD', 'LastName': 'Anastasilakis', 'Affiliation': 'Department of Endocrinology, 424 General Military Hospital, Thessaloniki, Greece. Electronic address: a.anastasilakis@gmail.com.'}]",Bone,['10.1016/j.bone.2020.115478'] 1771,32539204,The efficacy of macro-focused ultrasound in the treatment of upper facial laxity: A pilot study.,"BACKGROUND Recently, macro-focused ultrasound (MFU) has become a popular noninvasive esthetic treatment for facial laxity. However, there are no studies done that evaluated the use of MFU with a 2.0 mm transducer for upper facial lifting. AIMS To evaluate the efficacy and safety of MFU with a 2.0 mm transducer in the treatment of upper facial laxity in Thai patients. METHODS This was a prospective, evaluator-blinded pilot study with 34 Thai patients diagnosed with mild to moderate facial laxity. Patients were treated with a single session of MFU with 2.0 mm transducer at the forehead, lateral and just below the eye area. Primary outcome was the clinical improvement of upper facial laxity graded by 2 blinded dermatologists at baseline, 1-week, 1-, 3-, and 6-month follow-up. Objective measurements including eyebrow height, upper facial volume, and textural irregularities were evaluated. Patients' self-assessment scores and adverse effects were also recorded. RESULTS Out of 34 patients, 27 (79.4%) attended all follow-ups. Clinical improvement of upper facial laxity was observed as early as 1-week follow-up. Eyebrow height elevation was significantly increased at every follow-up (P = .000) with an average of 1.22 mm at 6-month follow-up. Wrinkles improved significantly at 1-week and 6-month follow-up (P = .002 and P = .010, respectively). Skin roughness showed significant improvement at 6-month follow-up (P = .004). Majority of the patients (53.6%) reported marked improvement at 3-month follow-up. No serious adverse event was noted. CONCLUSION Macro-focused ultrasound is a safe and effective treatment for upper facial laxity and skin textural irregularities in patients with mild to moderate degree of laxity.",2020,"Wrinkles improved significantly at 1-week and 6-month follow-up (p=0.002 and p=0.010, respectively).","['upper facial laxity in Thai patients', '34 Thai patients diagnosed with mild to moderate facial laxity', 'upper facial laxity', 'Out of 34 patients, 27 (79.4%) attended all follow-ups', 'patients with mild to moderate degree of laxity']","['macro-focused ultrasound', 'macro-focused ultrasound (MFU', 'MFU']","['clinical improvement of upper facial laxity graded by 2 blinded dermatologists', 'upper facial laxity', ""Patients' self-assessment scores and adverse effects"", 'Wrinkles', 'efficacy and safety', 'Skin roughness', 'Eyebrow height elevation', 'eyebrow height, upper facial volume and textural irregularities']","[{'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0332536', 'cui_str': 'Laxity'}, {'cui': 'C0039724', 'cui_str': 'Thai language'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]","[{'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0332536', 'cui_str': 'Laxity'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0259831', 'cui_str': 'Dermatologist'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036591', 'cui_str': 'Self Assessment'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0037301', 'cui_str': 'Wrinkled skin'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0859038', 'cui_str': 'Skin roughness'}, {'cui': 'C0015420', 'cui_str': 'Eyebrow structure'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0449468', 'cui_str': 'Volume'}]",34.0,0.027383,"Wrinkles improved significantly at 1-week and 6-month follow-up (p=0.002 and p=0.010, respectively).","[{'ForeName': 'Rungsima', 'Initials': 'R', 'LastName': 'Wanitphakdeedecha', 'Affiliation': 'Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Chadakan', 'Initials': 'C', 'LastName': 'Yan', 'Affiliation': 'Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Janice Natasha C', 'Initials': 'JNC', 'LastName': 'Ng', 'Affiliation': 'Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Ya-Nin', 'Initials': 'YN', 'LastName': 'Nokdhes', 'Affiliation': 'Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Ploypailin', 'Initials': 'P', 'LastName': 'Tantrapornpong', 'Affiliation': 'Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Thanya', 'Initials': 'T', 'LastName': 'Techapichetvanich', 'Affiliation': 'Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Sasima', 'Initials': 'S', 'LastName': 'Eimpunth', 'Affiliation': 'Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Woraphong', 'Initials': 'W', 'LastName': 'Manuskiatti', 'Affiliation': 'Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}]",Journal of cosmetic dermatology,['10.1111/jocd.13550'] 1772,32539812,Effects of transcranial direct current stimulation with virtual reality on upper limb function in patients with ischemic stroke: a randomized controlled trial.,"BACKGROUND Non-invasive brain stimulation techniques have been shown in several studies to improve the motor recovery of the affected upper-limbs in stroke patients. This study aims to investigate whether or not cathodal transcranial direct current stimulation (c-tDCS), combined with virtual reality (VR), is superior to VR alone in reducing motor impairment and improving upper limb function and quality of life in stroke patients. METHODS Forty patients who suffered ischemic stroke between 2 weeks to 12 months were recruited for this single-blind randomized control trial. The patients were randomly assigned either to an experimental group who receiving c-tDCS and VR, or a control group receiving sham stimulation and VR. The cathodal electrode was positioned over the primary motor cortex (M1) of the unaffected hemisphere. The treatment session consisted of 20 min of daily therapy, for 10 sessions over a 2-week period. The outcome measures were the Fugl-Meyer Upper Extremity (FM-UE), the Action Research Arm Test (ARAT) and the Barthel Index (BI). RESULTS The two groups were comparable in demographic characteristic and motor impairment. After 2 weeks of intervention, both groups demonstrated significant improvement in FM-UE, ARAT and BI scores (P<0.05).The experiment group demonstrated more improvement in FM-UE than the control group (10.1 vs. 6.4, p = 0.003) and, ARAT (7.0 vs 3.6, p = 0.026) and BI (12.8 vs 8.5, p = 0.043). CONCLUSIONS The findings from our study support that c-tDCS, along with VR, can facilitate a stronger beneficial effect on upper limb motor impairment, function and quality of life than VR alone in patients with ischemic stroke. TRIAL REGISTRATION The study was registered in the Chinese Clinical Trial Registry (ChiCTR1800019386) in November 8, 2018-Retrospectively registered.",2020,"After 2 weeks of intervention, both groups demonstrated significant improvement in FM-UE, ARAT and BI scores (P<0.05).The experiment group demonstrated more improvement in FM-UE than the control group (10.1 vs. 6.4, p = 0.003) and, ARAT (7.0 vs 3.6, p = 0.026) and BI (12.8 vs 8.5, p = 0.043). ","['stroke patients', 'patients with ischemic stroke', 'Forty patients who suffered ischemic stroke between 2\u2009weeks to 12\u2009months']","['cathodal transcranial direct current stimulation (c-tDCS), combined with virtual reality (VR', 'experimental group who receiving c-tDCS and VR, or a control group receiving sham stimulation and VR', 'transcranial direct current stimulation with virtual reality']","['ARAT', 'FM-UE', 'demographic characteristic and motor impairment', 'FM-UE, ARAT and BI scores', 'upper limb motor impairment, function and quality of life', 'Fugl-Meyer Upper Extremity (FM-UE), the Action Research Arm Test (ARAT) and the Barthel Index (BI', 'motor impairment and improving upper limb function and quality of life']","[{'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}]","[{'cui': 'C4720875', 'cui_str': 'Action research arm test'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0451019', 'cui_str': 'Barthel index'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0184511', 'cui_str': 'Improved'}]",40.0,0.105452,"After 2 weeks of intervention, both groups demonstrated significant improvement in FM-UE, ARAT and BI scores (P<0.05).The experiment group demonstrated more improvement in FM-UE than the control group (10.1 vs. 6.4, p = 0.003) and, ARAT (7.0 vs 3.6, p = 0.026) and BI (12.8 vs 8.5, p = 0.043). ","[{'ForeName': 'Xiaoling', 'Initials': 'X', 'LastName': 'Yao', 'Affiliation': 'Department of Rehabilitation Medicine, Ruijin Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Lijun', 'Initials': 'L', 'LastName': 'Cui', 'Affiliation': 'Department of Rehabilitation Medicine, Ruijin Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Jixian', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Rehabilitation Medicine, Ruijin Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Wuwei', 'Initials': 'W', 'LastName': 'Feng', 'Affiliation': 'Deparment of Neurology, Duke University Medical Center, Durham, North Carolina, USA.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Bao', 'Affiliation': 'Department of Rehabilitation Medicine, Shanghai Ruijin Rehabilitation Hospital, Shanghai, China. 15901999958@163.com.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Xie', 'Affiliation': 'Department of Rehabilitation Medicine, Ruijin Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, China. ruijin_xq@163.com.'}]",Journal of neuroengineering and rehabilitation,['10.1186/s12984-020-00699-x'] 1773,32540584,The effect of injection volume on long-term outcomes of US-guided subacromial bursa injections.,"PURPOSE Limited data exist on the efficacy of high- compared to low-volume US-guided corticosteroid injections (CI) in the subacromial-subdeltoid (SA-SD) bursa. Our purpose was to compare the short- and long-term efficacy of low- and high-volume injections, by using a capacity reference of SA-SD bursa volume, as assessed on cadaveric specimens. METHOD Within two years, 136 patients (63 males, 73 females; mean age: 46.11 ± 10.28 years) who underwent SA-SD bursa US-guided CI for subacromial impingement, rotator cuff tendinopathy or shoulder overuse were prospectively included. Patients were randomly assigned to low-volume (1 mL triamcinolone acetonide/40 mg) or high-volume (1 mL triamcinolone acetonide/40 mg, 9 mL anaesthetic agents) groups (67 and 69 patients, respectively). Visual Analogue Scores (VAS) were recorded at baseline, 30 min, 3 weeks, 3 months, 6 months and 1 year post-treatment. Predictors of complete recovery (VAS ≤ 2) at 1 year were analysed with multivariate Cox regression analysis. SA-SD bursa cadaveric dissection in 10 specimens was performed for volume assessment. RESULTS Injection volume was the only predictor of complete pain resolution at 1 year. High-volume CI yielded higher chances of early pain recovery (2.837 HR, 95% CI 1.737-4.633, P < .001). Mean VAS scores at baseline and subsequent time-points were 6, 2.6, 2.2, 2, 1.6 and 1 for the high-volume and 7.8, 7.3, 4.7, 3.2, 2.5 and 1.8 for the low-volume group, respectively (P < .001, at all time-points). Cadaveric measurements showed a minimum SA-SD bursa volume of approximately 6.9 mL. CONCLUSIONS High-compared to low-volume US-guided CI are superior for achieving early pain recovery.",2020,"High-volume CI yielded higher chances of early pain recovery (2.837 HR, 95% CI 1.737-4.633, P < .001).","['136 patients (63 males, 73 females; mean age: 46.11\u202f±\u202f10.28 years) who underwent SA-SD bursa US-guided CI for subacromial impingement, rotator cuff tendinopathy or shoulder overuse were prospectively included']","['US-guided subacromial bursa injections', 'low-volume US-guided corticosteroid injections (CI', 'low- and high-volume injections', 'triamcinolone acetonide/40\u202fmg) or high-volume (1\u202fmL triamcinolone acetonide/40\u202fmg, 9\u202fmL anaesthetic agents']","['minimum SA-SD bursa volume', 'complete pain resolution', 'chances of early pain recovery', 'Visual Analogue Scores (VAS', 'Mean VAS scores']","[{'cui': 'C4517568', 'cui_str': '136'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0006441', 'cui_str': 'Structure of bursa'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0376685', 'cui_str': 'Impingement syndrome of shoulder region'}, {'cui': 'C0085515', 'cui_str': 'Structure of rotator cuff including muscles and tendons'}, {'cui': 'C0151936', 'cui_str': 'Disorder of tendon'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0224792', 'cui_str': 'Structure of subacromial bursa'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0040864', 'cui_str': 'Triamcinolone'}, {'cui': 'C0002932', 'cui_str': 'Anesthetic'}]","[{'cui': 'C0006441', 'cui_str': 'Structure of bursa'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",,0.107082,"High-volume CI yielded higher chances of early pain recovery (2.837 HR, 95% CI 1.737-4.633, P < .001).","[{'ForeName': 'Michail E', 'Initials': 'ME', 'LastName': 'Klontzas', 'Affiliation': 'Department of Medical Imaging, University Hospital, Voutes, 71110, Heraklion, Crete, Greece; Advanced Hybrid Imaging Systems, Institute of Computer Science, Foundation for Research and Technology (FORTH), 100 N. Plastira str., Voutes, 70013, Heraklion, Crete, Greece.'}, {'ForeName': 'Evangelia E', 'Initials': 'EE', 'LastName': 'Vassalou', 'Affiliation': 'Department of Medical Imaging, University Hospital, Voutes, 71110, Heraklion, Crete, Greece; Department of Radiology, General Hospital of Sitia, Xserokamares, 72300, Sitia, Lasithi, Crete, Greece. Electronic address: vassalou.e@hotmail.com.'}, {'ForeName': 'Aristeidis H', 'Initials': 'AH', 'LastName': 'Zibis', 'Affiliation': 'University of Thessaly, Faculty of Medicine, Department of Anatomy Mezourlo Viopolis, 41222, Larissa, Greece.'}, {'ForeName': 'Apostolos H', 'Initials': 'AH', 'LastName': 'Karantanas', 'Affiliation': 'Department of Medical Imaging, University Hospital, Voutes, 71110, Heraklion, Crete, Greece; Department of Radiology, Medical School, University of Crete, Voutes, 71110, Heraklion, Greece.'}]",European journal of radiology,['10.1016/j.ejrad.2020.109113'] 1774,32540588,Deep transcranial magnetic stimulation for obsessive-compulsive disorder is efficacious even in patients who failed multiple medications and CBT.,"OCD is a chronic and disabling disease with a lifetime prevalence of 2%-3%. About 40-60% of these patients do not adequately respond to pharmacotherapy and CBT. Deep transcranial magnetic stimulation (dTMS) was shown to be safe and effective as a treatment alternative for OCD and recently received regulatory approvals. Yet it is unclear whether patients who failed numerous medications and/or CBT can still benefit from dTMS. Here, we analyzed recent data from a double-blind multicenter dTMS study and found efficacy of this novel treatment even in OCD patient cohorts who previously failed to respond to multiple medications and CBT.",2020,Deep transcranial magnetic stimulation (dTMS) was shown to be safe and effective as a treatment alternative for OCD and recently received regulatory approvals.,"['OCD patient cohorts who previously failed to respond to multiple medications and CBT', 'patients who failed multiple medications and CBT']","['OCD', 'Deep transcranial magnetic stimulation', 'Deep transcranial magnetic stimulation (dTMS']",[],"[{'cui': 'C0009595', 'cui_str': 'Obsessive compulsive personality disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C0009595', 'cui_str': 'Obsessive compulsive personality disorder'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation'}]",[],,0.0274375,Deep transcranial magnetic stimulation (dTMS) was shown to be safe and effective as a treatment alternative for OCD and recently received regulatory approvals.,"[{'ForeName': 'Yiftach', 'Initials': 'Y', 'LastName': 'Roth', 'Affiliation': 'The Department of Life Sciences and the Zlotowski Center for Neuroscience, Ben-Gurion University of the Negev, Beer-Sheva, Israel.'}, {'ForeName': 'Noam', 'Initials': 'N', 'LastName': 'Barnea-Ygael', 'Affiliation': 'The Department of Life Sciences and the Zlotowski Center for Neuroscience, Ben-Gurion University of the Negev, Beer-Sheva, Israel.'}, {'ForeName': 'Lior', 'Initials': 'L', 'LastName': 'Carmi', 'Affiliation': 'Chaim Sheba Medical Center, Ramat Gan, Israel.'}, {'ForeName': 'Eric A', 'Initials': 'EA', 'LastName': 'Storch', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Baylor College of Medicine, TX, USA.'}, {'ForeName': 'Aron', 'Initials': 'A', 'LastName': 'Tendler', 'Affiliation': 'Advanced Mental Health Care, Inc., Palm Beach, FL, USA.'}, {'ForeName': 'Abraham', 'Initials': 'A', 'LastName': 'Zangen', 'Affiliation': 'The Department of Life Sciences and the Zlotowski Center for Neuroscience, Ben-Gurion University of the Negev, Beer-Sheva, Israel. Electronic address: azangen@bgu.ac.il.'}]",Psychiatry research,['10.1016/j.psychres.2020.113179'] 1775,32540624,Effects of night-time bicycling visibility aids on vehicle passing distance.,"Bicycling at night is dangerous, with vehicle passing distances being a key concern, given that the main cause of night-time bicycling fatalities is from motorists hitting bicyclists from behind. However, little is known about vehicle passing distances at night or how they are affected by bicyclist visibility. This study assessed the impact of different bicyclist visibility configurations on vehicle passing distances at night-time. Fourteen licenced drivers with normal vision (age 24.2 ± 3.7 years) drove an experimental vehicle with low-beam headlights around a 1-km section of a closed-road circuit at night. Each lap involved passing two bicyclists displaying one of four visibility configurations: Control (red rear-facing light and reflector), Handlebars (control plus two red rear-facing lights on each handlebar), Helmet (control plus one red rear-facing light on the helmet), and Leg Retro-reflectors (control plus retro-reflective strips positioned on the knees and ankles). Participants were instructed to pass each bicyclist at a distance of 1-metre at a speed no greater than 50 km/hr, consistent with Queensland's Minimum Passing Distance rule. Participants completed eight laps, two for each configuration, in a randomised sequence. Passing distance was measured using a vehicle-mounted ultra-sonic sensor (ToughSonic14; Senix). Following each lap, participants rated the difficulty level in judging the 1-metre passing distance, as well as their estimated passing distance. Visibility configuration significantly affected passing distance (p = 0.001), with wider passing distances for the Handlebar configuration (1.54 ± 0.62 m), followed by the Helmet (1.51 ± 0.63 m), Leg Retro-reflectors (1.50 ± 0.62 m) which were all significantly greater than the Control (1.42 ± 0.57 m), but not significantly different from each other. There was also a significant effect of visibility configuration on difficulty rating (p = 0.035), with the Control rated as the most difficult, followed by Helmet, Handlebars and Leg Retro-reflectors. Overall, additional visibility aids resulted in wider vehicle passing distances, likely due to enhanced visual cues for drivers. The findings suggest that bicyclists should incorporate additional visibility aids to encourage safer passing distances of vehicles at night-time.",2020,"Visibility configuration significantly affected passing distance (p = 0.001), with wider passing distances for the Handlebar configuration (1.54 ± 0.62 m), followed by the Helmet (1.51 ± 0.63 m), Leg Retro-reflectors (1.50 ± 0.62 m) which were all significantly greater than the Control (1.42 ± 0.57 m), but not significantly different from each other.",['Fourteen licenced drivers with normal vision (age 24.2\u202f±\u202f3.7 years) drove an experimental vehicle with low-beam headlights around a 1-km section of a closed-road circuit at night'],"['visibility configurations: Control (red rear-facing light and reflector), Handlebars (control plus two red rear-facing lights on each handlebar), Helmet (control plus one red rear-facing light on the helmet), and Leg Retro-reflectors (control plus retro-reflective strips positioned on the knees and ankles', 'night-time bicycling visibility aids']","['visibility configuration on difficulty rating', 'Leg Retro-reflectors']","[{'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0684312', 'cui_str': 'Vehicle driver'}, {'cui': 'C0234622', 'cui_str': 'Normal vision'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517696', 'cui_str': '3.7'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0042444', 'cui_str': 'Drug vehicle'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0442650', 'cui_str': 'Road'}, {'cui': 'C0240526', 'cui_str': 'Night time'}]","[{'cui': 'C0449830', 'cui_str': 'With configuration'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332575', 'cui_str': 'Red color'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0018884', 'cui_str': 'Helmet'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0185047', 'cui_str': 'Stripping'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0005375', 'cui_str': 'Bicycle'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}]","[{'cui': 'C0449830', 'cui_str': 'With configuration'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}]",,0.0635457,"Visibility configuration significantly affected passing distance (p = 0.001), with wider passing distances for the Handlebar configuration (1.54 ± 0.62 m), followed by the Helmet (1.51 ± 0.63 m), Leg Retro-reflectors (1.50 ± 0.62 m) which were all significantly greater than the Control (1.42 ± 0.57 m), but not significantly different from each other.","[{'ForeName': 'Alex A', 'Initials': 'AA', 'LastName': 'Black', 'Affiliation': 'Queensland University of Technology (QUT), Centre for Vision and Eye Research, Institute of Health and Biomedical Innovation, Kelvin Grove, Brisbane, QLD 4059, Australia. Electronic address: aa.black@qut.edu.au.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Duff', 'Affiliation': 'Queensland University of Technology (QUT), Centre for Vision and Eye Research, Institute of Health and Biomedical Innovation, Kelvin Grove, Brisbane, QLD 4059, Australia.'}, {'ForeName': 'Madeline', 'Initials': 'M', 'LastName': 'Hutchinson', 'Affiliation': 'Queensland University of Technology (QUT), Centre for Vision and Eye Research, Institute of Health and Biomedical Innovation, Kelvin Grove, Brisbane, QLD 4059, Australia.'}, {'ForeName': 'Ingrid', 'Initials': 'I', 'LastName': 'Ng', 'Affiliation': 'Queensland University of Technology (QUT), Centre for Vision and Eye Research, Institute of Health and Biomedical Innovation, Kelvin Grove, Brisbane, QLD 4059, Australia.'}, {'ForeName': 'Kirby', 'Initials': 'K', 'LastName': 'Phillips', 'Affiliation': 'Queensland University of Technology (QUT), Centre for Vision and Eye Research, Institute of Health and Biomedical Innovation, Kelvin Grove, Brisbane, QLD 4059, Australia.'}, {'ForeName': 'Katelyn', 'Initials': 'K', 'LastName': 'Rose', 'Affiliation': 'Queensland University of Technology (QUT), Centre for Vision and Eye Research, Institute of Health and Biomedical Innovation, Kelvin Grove, Brisbane, QLD 4059, Australia.'}, {'ForeName': 'Abby', 'Initials': 'A', 'LastName': 'Ussher', 'Affiliation': 'Queensland University of Technology (QUT), Centre for Vision and Eye Research, Institute of Health and Biomedical Innovation, Kelvin Grove, Brisbane, QLD 4059, Australia.'}, {'ForeName': 'Joanne M', 'Initials': 'JM', 'LastName': 'Wood', 'Affiliation': 'Queensland University of Technology (QUT), Centre for Vision and Eye Research, Institute of Health and Biomedical Innovation, Kelvin Grove, Brisbane, QLD 4059, Australia.'}]",Accident; analysis and prevention,['10.1016/j.aap.2020.105636'] 1776,32554183,The interactive effects of test-retest and methylphenidate administration on cognitive performance in youth with ADHD: A double-blind placebo-controlled crossover study.,"Studies have shown that Methylphenidate (MPH) affects cognitive performance on the neuropsychological tests and clinical symptoms of individuals diagnosed with attention deficit/hyperactivity disorder (ADHD). This study investigated the acute effects of MPH on neuropsychological tests to explore the interaction between MPH and test-retest effects. Twenty youths with ADHD were tested before and after MPH intake in a double-blind placebo-controlled crossover design and compared to twenty matched controls. Participants were tested on a range of standardized tasks including sustained attention to response, N-Back, and Word/Color Stroop. Identical tasks were administered twice each testing day, before and 1 hour after MPH/Placebo administration. Healthy controls were tested similarly with no intervention. Decreases in response time (RT) variability across tasks and in commission errors were found in ADHD after MPH. Conversely, a significant increase in RT variability and increase in omission errors were observed after the placebo. In the control group, RT variability and omission errors increased whereas commission errors decreased, suggesting fatigue and practice effects, respectively. Test-retest reliability was higher in controls than ADHD. It is suggested that cognitive tests are sensitive objective measures for the assessment of responses to MPH in ADHD but are also affected by repetition and fatigue.",2020,"In the control group, RT variability and omission errors increased whereas commission errors decreased, suggesting fatigue and practice effects, respectively.","['youth with ADHD', 'individuals diagnosed with attention deficit/hyperactivity disorder (ADHD', 'Twenty youths with ADHD']","['Methylphenidate (MPH', 'methylphenidate', 'placebo']","['cognitive performance', 'RT variability and omission errors', 'Test-retest reliability', 'sustained attention to response, N-Back, and Word/Color Stroop', 'RT variability', 'response time (RT) variability across tasks and in commission errors', 'omission errors', 'commission errors']","[{'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0025810', 'cui_str': 'Methylphenidate'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0035035', 'cui_str': 'Reliability (Epidemiology)'}, {'cui': 'C0589099', 'cui_str': 'Sustained attention'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0009393', 'cui_str': 'Color'}]",20.0,0.196672,"In the control group, RT variability and omission errors increased whereas commission errors decreased, suggesting fatigue and practice effects, respectively.","[{'ForeName': 'Itai', 'Initials': 'I', 'LastName': 'Horowitz', 'Affiliation': ""Ruth Rappaport Children's Hospital, Rambam Medical Center, Haifa, Israel; Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel. Electronic address: itaizen@gmail.com.""}, {'ForeName': 'Keren', 'Initials': 'K', 'LastName': 'Avirame', 'Affiliation': ""Ruth Rappaport Children's Hospital, Rambam Medical Center, Haifa, Israel; Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.""}, {'ForeName': 'Jodie', 'Initials': 'J', 'LastName': 'Naim-Feil', 'Affiliation': 'Department of Physics of Complex Systems, The Weizmann Institute of Science, Rehovot, Israel; Sagol Center for Brain and Mind, Baruch Ivcher School of Psychology, Interdisciplinary Center (IDC), Herzliya, Israel.'}, {'ForeName': 'Mica', 'Initials': 'M', 'LastName': 'Rubinson', 'Affiliation': 'Department of Physics of Complex Systems, The Weizmann Institute of Science, Rehovot, Israel.'}, {'ForeName': 'Elisha', 'Initials': 'E', 'LastName': 'Moses', 'Affiliation': 'Department of Physics of Complex Systems, The Weizmann Institute of Science, Rehovot, Israel.'}, {'ForeName': 'Doron', 'Initials': 'D', 'LastName': 'Gothelf', 'Affiliation': ""Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel; Child and Adolescent Psychiatry Division, The Edmond and Lily Safra Children's Hospital, Sheba Medical Center, Israel; Sagol School of Neuroscience, Tel Aviv University, Tel Aviv, Israel.""}, {'ForeName': 'Nava', 'Initials': 'N', 'LastName': 'Levit-Binnun', 'Affiliation': 'Sagol Center for Brain and Mind, Baruch Ivcher School of Psychology, Interdisciplinary Center (IDC), Herzliya, Israel.'}]",Psychiatry research,['10.1016/j.psychres.2020.113056'] 1777,32554218,Potential benefits of environmental volunteering programs of the health of older adults: a pilot study.,"PURPOSE To study the effects of participating in a 12-week environmental volunteering program on the physical performance of older adults across different age groups MATERIALS AND METHODS: We conducted a pretest-posttest pilot study with a single group. The intervention consisted of twice-weekly recycling activities and once-weekly rehabilitation exercise at community-based care centers. The recycling activities of the environmental volunteering program included sorting and handling paper products, plastics, and metals; disposing electronic products; and sorting clothes. The rehabilitation exercise program comprised a 90-min course for special needs and 30 min of health education. The evaluation tools were the handgrip strength, five-times-sit-to-stand test, sit-and-reach test, Timed Up and Go (TUG) test and usual and fast gait speeds. RESULTS In total, 45 participants completed the program. After the program, the participants showed significantly great improvements compared to baseline in all outcome measures. We further divided these participants into two age subgroups [65-75 years (n = 31) and >75 years (n = 14)]. The 65-75-year subgroup only showed significant improvements in handgrip strength, TUG and usual gait speed. However, the >75-year subgroup showed significant improvements in all outcome measures. CONCLUSIONS This innovative environmental volunteering program conducted in a local Taiwanese community can be a sustainable and feasible model to improve physical performance in the participants, the subgroup aged >75 years in particular. It also provides a potential avenue for researchers and policymakers to address environmental and aging-related issues.",2020,"The 65-75-year subgroup only showed significant improvements in handgrip strength, TUG and usual gait speed.","['older adults across different age groups', 'older adults', 'participants into two age subgroups [65-75 years (n\u2009=\u200931) and >75 years (n\u2009=\u200914', 'participants, the subgroup aged >75 years in particular', '45 participants completed the program']","['twice-weekly recycling activities and once-weekly rehabilitation exercise at community-based care centers', 'rehabilitation exercise program', 'environmental volunteering program', 'environmental volunteering programs']","['handgrip strength, TUG and usual gait speed', 'handgrip strength, five-times-sit-to-stand test, sit-and-reach test, Timed Up and Go (TUG) test and usual and fast gait speeds']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0027362', 'cui_str': 'Age Groups'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0556985', 'cui_str': 'Twice weekly'}, {'cui': 'C0282114', 'cui_str': 'Recycling'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0558293', 'cui_str': 'Once a week'}, {'cui': 'C0452240', 'cui_str': 'Exercises'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0014406', 'cui_str': 'Environment'}]","[{'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0560801', 'cui_str': 'Does stand from sitting'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}]",45.0,0.0265483,"The 65-75-year subgroup only showed significant improvements in handgrip strength, TUG and usual gait speed.","[{'ForeName': 'Jia-Ching', 'Initials': 'JC', 'LastName': 'Chen', 'Affiliation': 'Department of Rehabilitation Medicine, Buddhist Tzu Chi General Hospital, Hualien, Taiwan; Department of Physical Therapy, Tzu Chi University, Hualien, Taiwan.'}, {'ForeName': 'Qi-Xing', 'Initials': 'QX', 'LastName': 'Chang', 'Affiliation': 'Department of Rehabilitation Medicine, Buddhist Tzu Chi General Hospital, Hualien, Taiwan.'}, {'ForeName': 'Chung-Chao', 'Initials': 'CC', 'LastName': 'Liang', 'Affiliation': 'Department of Rehabilitation Medicine, Buddhist Tzu Chi General Hospital, Hualien, Taiwan; Department of Medicine, Tzu Chi University, Hualien, Taiwan.'}, {'ForeName': 'Jyh-Gang', 'Initials': 'JG', 'LastName': 'Hsieh', 'Affiliation': 'Department of Family Medicine, Buddhist Tzu Chi General Hospital, Hualien, Taiwan.'}, {'ForeName': 'Peter Pin-Sung', 'Initials': 'PP', 'LastName': 'Liu', 'Affiliation': 'Center for Aging and Health, Buddhist Tzu Chi General Hospital, Hualien, Taiwan.'}, {'ForeName': 'Chia-Feng', 'Initials': 'CF', 'LastName': 'Yen', 'Affiliation': 'Department of Public Health, Tzu Chi University, Hualien, Taiwan. Electronic address: mapleyeng@gmail.com.'}, {'ForeName': 'Ching-Hui', 'Initials': 'CH', 'LastName': 'Loh', 'Affiliation': 'Department of Family Medicine, Buddhist Tzu Chi General Hospital, Hualien, Taiwan; Center for Aging and Health, Buddhist Tzu Chi General Hospital, Hualien, Taiwan. Electronic address: twdoc1960@gmail.com.'}]",Archives of gerontology and geriatrics,['10.1016/j.archger.2020.104113'] 1778,32554291,Community level interventions for pre-eclampsia (CLIP) in India: A cluster randomised controlled trial.,"OBJECTIVES Pregnancy hypertension is associated with 7.1% of maternal deaths in India. The objective of this trial was to assess whether task-sharing care might reduce adverse pregnancy outcomes related to delays in triage, transport, and treatment. STUDY DESIGN The Indian Community-Level Interventions for Pre-eclampsia (CLIP) open-label cluster randomised controlled trial (NCT01911494) recruited pregnant women in 12 clusters (initial four-cluster internal pilot) in Belagavi and Bagalkote, Karnataka. The CLIP intervention (6 clusters) consisted of community engagement, community health workers (CHW) provided mobile health (mHeath)-guided clinical assessment, initial treatment, and referral to facility either urgently (<4 h) or non-urgently (<24 h), dependent on algorithm-defined risk. Treatment effect was estimated by multi-level logistic regression modelling, adjusted for prognostically-significant baseline variables. Predefined secondary analyses included safety and evaluation of the intensity of mHealth-guided CHW-provided contacts. MAIN OUTCOME MEASURES 20% reduction in composite of maternal, fetal, and newborn mortality and major morbidity. RESULTS All 14,783 recruited pregnancies (7839 intervention, 6944 control) were followed-up. The primary outcome did not differ between intervention and control arms (adjusted odds ratio (aOR) 0.92 [95% confidence interval 0.74, 1.15]; p = 0.47; intraclass correlation coefficient 0.013). There were no intervention-related safety concerns following administration of either methyldopa or MgSO 4 , and 401 facility referrals. Compared with intervention arm women without CLIP contacts, those with ≥8 contacts suffered fewer stillbirths (aOR 0.19 [0.10, 0.35]; p < 0.001), at the probable expense of survivable neonatal morbidity (aOR 1.39 [0.97, 1.99]; p = 0.072). CONCLUSIONS As implemented, solely community-level interventions focussed on pre-eclampsia did not improve outcomes in northwest Karnataka.",2020,"There were no intervention-related safety concerns following administration of either methyldopa or MgSO 4 , and 401 facility referrals.","['All 14,783 recruited pregnancies (7839 intervention, 6944 control) were followed-up', 'pregnant women in 12 clusters (initial four-cluster internal pilot) in Belagavi and Bagalkote, Karnataka', 'pre-eclampsia (CLIP) in India']","['CLIP intervention (6 clusters) consisted of community engagement, community health workers (CHW) provided mobile health (mHeath)-guided clinical assessment, initial treatment, and referral to facility either urgently (<4\xa0h) or non-urgently', 'task-sharing care', 'Community level interventions', 'methyldopa']","['safety and evaluation of the intensity of mHealth-guided CHW-provided contacts', 'survivable neonatal morbidity', 'composite of maternal, fetal, and newborn mortality and major morbidity']","[{'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0473169', 'cui_str': 'Pilot - aircraft'}, {'cui': 'C0032914', 'cui_str': 'Pre-eclampsia'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021201', 'cui_str': 'India'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0032914', 'cui_str': 'Pre-eclampsia'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0009467', 'cui_str': 'Community Health Aides'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C2585021', 'cui_str': 'Referral to'}, {'cui': 'C0025741', 'cui_str': 'Methyldopa'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0009467', 'cui_str': 'Community Health Aides'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0015965', 'cui_str': 'Fetuses'}, {'cui': 'C0027616', 'cui_str': 'Neonatal Mortality'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]",,0.32665,"There were no intervention-related safety concerns following administration of either methyldopa or MgSO 4 , and 401 facility referrals.","[{'ForeName': 'Mrutunjaya B', 'Initials': 'MB', 'LastName': 'Bellad', 'Affiliation': ""KLE Academy of Higher Education and Research's J N Medical College, Nehru Nagar, Belagavi, 590010 Karnataka, India. Electronic address: mbbellad@hotmail.com.""}, {'ForeName': 'Shivaprasad S', 'Initials': 'SS', 'LastName': 'Goudar', 'Affiliation': ""KLE Academy of Higher Education and Research's J N Medical College, Nehru Nagar, Belagavi, 590010 Karnataka, India.""}, {'ForeName': 'Ashalata A', 'Initials': 'AA', 'LastName': 'Mallapur', 'Affiliation': 'S Nijalingappa Medical College, HSK (Hanagal Shree Kumareshwar) Hospital and Research Centre, Navanagar, Bagalkot, 587102 Karnataka, India.'}, {'ForeName': 'Sumedha', 'Initials': 'S', 'LastName': 'Sharma', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver, BC V6Z 2K8, Canada.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Bone', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver, BC V6Z 2K8, Canada.'}, {'ForeName': 'Umesh S', 'Initials': 'US', 'LastName': 'Charantimath', 'Affiliation': ""KLE Academy of Higher Education and Research's J N Medical College, Nehru Nagar, Belagavi, 590010 Karnataka, India.""}, {'ForeName': 'Geetanjali M', 'Initials': 'GM', 'LastName': 'Katageri', 'Affiliation': 'S Nijalingappa Medical College, HSK (Hanagal Shree Kumareshwar) Hospital and Research Centre, Navanagar, Bagalkot, 587102 Karnataka, India.'}, {'ForeName': 'Umesh Y', 'Initials': 'UY', 'LastName': 'Ramadurg', 'Affiliation': 'S Nijalingappa Medical College, HSK (Hanagal Shree Kumareshwar) Hospital and Research Centre, Navanagar, Bagalkot, 587102 Karnataka, India.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Mark Ansermino', 'Affiliation': 'Centre for International Child Health, 305 - 4088 Cambie Street, Vancouver V5Z 2X8, Canada.'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Derman', 'Affiliation': 'Global Affairs, 1020 Walnut Street, Thomas Jefferson University, Philadelphia 19107, USA.'}, {'ForeName': 'Dustin T', 'Initials': 'DT', 'LastName': 'Dunsmuir', 'Affiliation': 'Centre for International Child Health, 305 - 4088 Cambie Street, Vancouver V5Z 2X8, Canada.'}, {'ForeName': 'Narayan V', 'Initials': 'NV', 'LastName': 'Honnungar', 'Affiliation': ""KLE Academy of Higher Education and Research's J N Medical College, Nehru Nagar, Belagavi, 590010 Karnataka, India.""}, {'ForeName': 'Chandrashekhar', 'Initials': 'C', 'LastName': 'Karadiguddi', 'Affiliation': ""KLE Academy of Higher Education and Research's J N Medical College, Nehru Nagar, Belagavi, 590010 Karnataka, India.""}, {'ForeName': 'Avinash J', 'Initials': 'AJ', 'LastName': 'Kavi', 'Affiliation': ""KLE Academy of Higher Education and Research's J N Medical College, Nehru Nagar, Belagavi, 590010 Karnataka, India.""}, {'ForeName': 'Bhalachandra S', 'Initials': 'BS', 'LastName': 'Kodkany', 'Affiliation': ""KLE Academy of Higher Education and Research's J N Medical College, Nehru Nagar, Belagavi, 590010 Karnataka, India.""}, {'ForeName': 'Tang', 'Initials': 'T', 'LastName': 'Lee', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver, BC V6Z 2K8, Canada.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver, BC V6Z 2K8, Canada.'}, {'ForeName': 'Hannah L', 'Initials': 'HL', 'LastName': 'Nathan', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, St. Thomas' Hospital, Westminster Bridge Road, London SE1 7EH, UK.""}, {'ForeName': 'Beth A', 'Initials': 'BA', 'LastName': 'Payne', 'Affiliation': 'Centre for International Child Health, 305 - 4088 Cambie Street, Vancouver V5Z 2X8, Canada.'}, {'ForeName': 'Amit P', 'Initials': 'AP', 'LastName': 'Revankar', 'Affiliation': ""KLE Academy of Higher Education and Research's J N Medical College, Nehru Nagar, Belagavi, 590010 Karnataka, India.""}, {'ForeName': 'Andrew H', 'Initials': 'AH', 'LastName': 'Shennan', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, St. Thomas' Hospital, Westminster Bridge Road, London SE1 7EH, UK.""}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Singer', 'Affiliation': ""Centre for Health Evaluation and Outcome Sciences, Providence Health Care Research Institute, University of British Columbia, 588 - 1081 Burrard Street, St. Paul's Hospital, Vancouver V6Z 1Y6, Canada.""}, {'ForeName': 'Domena K', 'Initials': 'DK', 'LastName': 'Tu', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver, BC V6Z 2K8, Canada.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Vidler', 'Affiliation': 'Department of Obstetrics and Gynaecology, Faculty of Medicine, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver, BC V6Z 2K8, Canada; Centre for International Child Health, 305 - 4088 Cambie Street, Vancouver V5Z 2X8, Canada.'}, {'ForeName': 'Hubert', 'Initials': 'H', 'LastName': 'Wong', 'Affiliation': ""Centre for Health Evaluation and Outcome Sciences, Providence Health Care Research Institute, University of British Columbia, 588 - 1081 Burrard Street, St. Paul's Hospital, Vancouver V6Z 1Y6, Canada.""}, {'ForeName': 'Zulfiqar A', 'Initials': 'ZA', 'LastName': 'Bhutta', 'Affiliation': 'Centre for Global Child Health, Hospital for Sick Children, 525 University Avenue, Suite 702, Toronto M5G 2L3, Canada; Aga Khan University, Stadium Road, P.O. Box 3500, Karachi 74800, Pakistan.'}, {'ForeName': 'Laura A', 'Initials': 'LA', 'LastName': 'Magee', 'Affiliation': ""Department of Obstetrics and Gynaecology, Faculty of Medicine, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver, BC V6Z 2K8, Canada; Department of Women and Children's Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, St. Thomas' Hospital, Westminster Bridge Road, London SE1 7EH, UK.""}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'von Dadelszen', 'Affiliation': ""Department of Obstetrics and Gynaecology, Faculty of Medicine, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver, BC V6Z 2K8, Canada; Department of Women and Children's Health, School of Life Course Sciences, Faculty of Life Sciences and Medicine, King's College London, St. Thomas' Hospital, Westminster Bridge Road, London SE1 7EH, UK.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Pregnancy hypertension,['10.1016/j.preghy.2020.05.008'] 1779,32555990,Intrathyroid injection of dexamethasone inhibits Th2 cells in Graves' disease.,"OBJECTIVE Intrathyroid injection of dexamethasone (IID) was used for decrease the relapse rate of hyperthyroidism in the treatment of Graves' disease (GD), but the mechanism is still unclear. We aimed to explore the effect of IID on T help (Th)1/Th2 cells and their chemokine in patients with GD. SUBJECTS AND METHODS A total of 42 patients with GD who were euthyroidism by methimazole were randomly divided into IID group (n = 20) and control group (n = 22). Thyroid function and associated antibody, Th1/Th2 cells proportion, serum CXCL10 and CCL2 levels, and CXCR3/CCR2 mRNA expression in peripheral blood mononuclear cells before and after 3-month IID treatment were tested by chemiluminescence assay, Flow cytometry, ELISA, and real-time PCR, respectively. Thyroid follicular cells were stimulated by IFN-γ and TNF-α and treated with dexamethasone in vitro. CXCL10 and CCL2 levels in supernatant were determined. RESULTS After 3-month therapy, the proportion of Th2 cells and serum CCL2 levels, as well as TPOAb, TRAb levels and thyroid volume decreased in IID group (p < 0.05). However, the proportion of Th1 and CXCL10 levels had no change in IID group and control (p > 0.05). The CXCR3/CCR2 ratio had no change in both groups (p > 0.05). CONCLUSION IID therapy could inhibit peripheral Th2 cells via decreasing CCL2 level in peripheral blood, and this result partly explain the effects of IID therapy on prevention of relapse of GD. Arch Endocrinol Metab. 2020;64(3):243-50.",2020,"Thyroid follicular cells were stimulated by IFN-γ and TNF-α and treated with dexamethasone in vitro. CXCL10 and CCL2 levels in supernatant were determined. ","['patients with GD', '42 patients with GD who were euthyroidism by methimazole', ""Graves' disease"", ""Graves' disease (GD""]","['dexamethasone', 'dexamethasone (IID']","['proportion of Th2 cells and serum CCL2 levels', 'CXCR3/CCR2 ratio', 'Thyroid follicular cells', 'TPOAb, TRAb levels and thyroid volume', 'Thyroid function and associated antibody, Th1/Th2 cells proportion, serum CXCL10 and CCL2 levels, and CXCR3/CCR2 mRNA expression in peripheral blood mononuclear cells', 'proportion of Th1 and CXCL10 levels', 'relapse rate of hyperthyroidism']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0025644', 'cui_str': 'Methimazole'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}]","[{'cui': 'C0242633', 'cui_str': 'T helper subset 2 cell'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C1449159', 'cui_str': 'CCL2 protein, human'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C1181052', 'cui_str': 'Thyrocytes'}, {'cui': 'C0040132', 'cui_str': 'Thyroid structure'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C1308752', 'cui_str': 'CXCL10 protein, human'}, {'cui': 'C0035696', 'cui_str': 'Messenger RNA'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C1321301', 'cui_str': 'Peripheral blood mononuclear cell'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0020550', 'cui_str': 'Hyperthyroidism'}]",42.0,0.0193606,"Thyroid follicular cells were stimulated by IFN-γ and TNF-α and treated with dexamethasone in vitro. CXCL10 and CCL2 levels in supernatant were determined. ","[{'ForeName': 'Ke', 'Initials': 'K', 'LastName': 'He', 'Affiliation': 'Department of Endocrinology, Wuxi Hospital of Traditional Chinese Medicine, Wuxi Hospital Affiliated to Nanjing University of Chinese Medicine, Wuxi, China.'}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Jiang', 'Affiliation': 'Department of Thyroid and Breast Surgery, Nanjing First Hospital, Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Bing-Li', 'Initials': 'BL', 'LastName': 'Liu', 'Affiliation': 'Department of Endocrinology, Nanjing First Hospital, Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Xiao-Mei', 'Initials': 'XM', 'LastName': 'Liu', 'Affiliation': 'Department of Endocrinology, Nanjing First Hospital, Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Xiao-Ming', 'Initials': 'XM', 'LastName': 'Mao', 'Affiliation': 'Department of Endocrinology, Nanjing First Hospital, Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': 'Department of Endocrinology, Nanjing First Hospital, Nanjing Medical University, Nanjing, China.'}]",Archives of endocrinology and metabolism,['10.20945/2359-3997000000244'] 1780,32555996,Metformin for prevention of cesarean delivery and large-for-gestational-age newborns in non-diabetic obese pregnant women: a randomized clinical trial.,"OBJECTIVE To evaluate the use of metformin for preventing cesarean deliveries and large-for-gestational-age (LGA) newborn (NB) outcomes in non-diabetic obese pregnant women. SUBJECTS AND METHODS This is a randomized clinical trial with obese pregnant women, divided into 2 groups: metformin group and control group, with followed-up prenatal routine. The gestational age of participants was less than or equal to 20 weeks and were monitored throughout entire prenatal period. For outcomes of delivery and LGA newborns, absolute risk reduction (ARR) and the number needed to treat (NNT) were calculated with a 95% confidence interval (CI). RESULTS 357 pregnant women were evaluated. From the metformin group (n = 171), 68 (39.8%) subjects underwent cesarean delivery, and 117 (62.9%) subjects from the control group (n = 186) had intercurrence (p < 0.01). As for the mothers' general characteristics, there was significance for marital status (p < 0.01). Maternal-fetal results presented reduced preeclampsia (p < 0,01). Primary prophylactic results presented an ARR of 23.1 times (95% CI: 13.0-33.4) with NNT of 4 (95% CI: 3.0-7.7) and no significant values for LGA NB (p > 0.01). Secondary prophylactic outcomes presented decreased odds ratio for preeclampsia (OR = 0.17, 95% CI: 0.10-0.41). CONCLUSION The use of metformin reduced cesarean section rates, resulted in a small number of patients to be treated, but it did not reduce LGA NB. Administering a lower dosage of metformin from the early stages to the end of treatment may yield significant results with fewer side effects. Arch Endocrinol Metab. 2020;64(3):290-7.",2020,"Secondary prophylactic outcomes presented decreased odds ratio for preeclampsia (OR = 0.17, 95% CI: 0.10-0.41). ","['obese pregnant women', '357 pregnant women', 'non-diabetic obese pregnant women', 'cesarean delivery and large-for-gestational-age newborns in non-diabetic obese pregnant women']","['Metformin', 'metformin group and control group, with followed-up prenatal routine', 'metformin']","['odds ratio for preeclampsia', 'cesarean section rates', 'cesarean deliveries and large-for-gestational-age (LGA) newborn (NB) outcomes', 'absolute risk reduction (ARR) and the number needed to treat (NNT', 'preeclampsia']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C4304643', 'cui_str': 'Large for gestational age newborn'}]","[{'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0205547', 'cui_str': 'Routine'}]","[{'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}, {'cui': 'C0032914', 'cui_str': 'Pre-eclampsia'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C1848395', 'cui_str': 'Large for dates baby'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C3179139', 'cui_str': 'Absolute Risk Reduction'}, {'cui': 'C3179138', 'cui_str': 'Numbers Needed To Treat'}]",357.0,0.0746908,"Secondary prophylactic outcomes presented decreased odds ratio for preeclampsia (OR = 0.17, 95% CI: 0.10-0.41). ","[{'ForeName': 'Iramar Baptistella do', 'Initials': 'IBD', 'LastName': 'Nascimento', 'Affiliation': 'Centro de Ciências da Saúde e do Esporte (Cefid), Universidade do Estado de Santa Catarina (Udesc), Florianópolis, SC, Brasil.'}, {'ForeName': 'Willian Barbosa', 'Initials': 'WB', 'LastName': 'Sales', 'Affiliation': 'Universidade da Região de Joinville (Univille), Joinville, SC, Brasil.'}, {'ForeName': 'Guilherme', 'Initials': 'G', 'LastName': 'Dienstmann', 'Affiliation': 'Universidade da Região de Joinville (Univille), Joinville, SC, Brasil.'}, {'ForeName': 'Matheus Leite Ramos de', 'Initials': 'MLR', 'LastName': 'Souza', 'Affiliation': 'Universidade da Região de Joinville (Univille), Joinville, SC, Brasil.'}, {'ForeName': 'Raquel', 'Initials': 'R', 'LastName': 'Fleig', 'Affiliation': 'Centro de Educação do Planalto Norte (Ceplan), Universidade do Estado de Santa Catarina (Udesc), Florianópolis, SC, Brasil.'}, {'ForeName': 'Jean Carl', 'Initials': 'JC', 'LastName': 'Silva', 'Affiliation': 'Maternidade Darcy Vargas; Universidade da Região de Joinville (Univille), Joinville, SC, Brasil.'}]",Archives of endocrinology and metabolism,['10.20945/2359-3997000000251'] 1781,32559716,A randomized controlled trial of digital cognitive behavioral therapy for insomnia in pregnant women.,"OBJECTIVE Despite high rates of prenatal insomnia, efficacious treatment options for this population are quite limited. Early evidence from randomized controlled trials (RCTs) support the efficacy of face-to-face cognitive-behavioral therapy for insomnia (CBTI) for prenatal insomnia. Yet, as many patients are unable to access this specialist-driven care, a critical need exists to increase its accessibility. This RCT examined the efficacy internet-based digital CBTI in pregnant women with insomnia. METHODS Single-site RCT. A total of 91 pregnant women (29.03 ± 4.16 years) nearing/entering the third trimester who screened positive for clinical insomnia on the Insomnia Severity Index (ISI) were randomized to digital CBTI or digital sleep education control. The ISI, Pittsburgh Sleep Quality Index (PSQI), Edinburgh Postnatal Depression Scale (EPDS), and Pre-Sleep Arousal Scale's Cognitive factor (PSAS-C) served as study outcomes, which were collected before treatment and after treatment during pregnancy, then six weeks after childbirth. RESULTS From pre to posttreatment, CBTI patients reported reductions in ISI (-4.91 points, p < 0.001) and PSQI (-2.98 points, p < 0.001) and increases in nightly sleep duration by 32 min (p = 0.008). Sleep symptoms did not change during pregnancy in the control group. After childbirth, CBTI patients, relative to controls, slept longer by 40 min per night (p = 0.01) and reported better sleep maintenance. No pre or postnatal treatment effects on depression or cognitive arousal were observed. CONCLUSIONS Digital CBTI improves sleep quality and sleep duration during pregnancy and after childbirth. To better optimize outcomes, CBTI should be tailored to meet the changing needs of women as the progress through pregnancy and early parenting. NAME: Insomnia and Rumination in Late Pregnancy and the Risk for Postpartum Depression. URL: clinicaltrials.gov. Registration: NCT03596879.",2020,"From pre to posttreatment, CBTI patients reported reductions in ISI (-4.91 points, p < 0.001) and PSQI (-2.98 points, p < 0.001) and increases in nightly sleep duration by 32 min (p = 0.008).","['insomnia (CBTI) for prenatal insomnia', 'pregnant women with insomnia', '91 pregnant women (29.03\xa0±\xa04.16 years) nearing/entering the third trimester who screened positive for clinical insomnia on the Insomnia Severity Index (ISI', 'pregnant women']","['Digital CBTI', 'digital CBTI or digital sleep education control', 'digital cognitive behavioral therapy', 'face-to-face cognitive-behavioral therapy', 'NAME']","['nightly sleep duration', 'PSQI', 'sleep quality and sleep duration', 'sleep maintenance', 'ISI', 'depression or cognitive arousal', ""ISI, Pittsburgh Sleep Quality Index (PSQI), Edinburgh Postnatal Depression Scale (EPDS), and Pre-Sleep Arousal Scale's Cognitive factor (PSAS-C"", 'Sleep symptoms', 'Insomnia and Rumination in Late Pregnancy and the Risk for Postpartum Depression']","[{'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0475806', 'cui_str': '1/3 meter'}, {'cui': 'C1522196', 'cui_str': 'Enteral route'}, {'cui': 'C0032981', 'cui_str': 'Third trimester pregnancy'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C4520529', 'cui_str': 'Insomnia severity index'}]","[{'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}]","[{'cui': 'C0424574', 'cui_str': 'Duration of sleep'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C4520529', 'cui_str': 'Insomnia severity index'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0451144', 'cui_str': 'Edinburgh postnatal depression scale'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0154575', 'cui_str': 'Rumination disorder'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0221074', 'cui_str': 'Postpartum depression'}]",91.0,0.126542,"From pre to posttreatment, CBTI patients reported reductions in ISI (-4.91 points, p < 0.001) and PSQI (-2.98 points, p < 0.001) and increases in nightly sleep duration by 32 min (p = 0.008).","[{'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Kalmbach', 'Affiliation': 'Thomas Roth Sleep Disorders & Research Center, Henry Ford Health System, Detroit, MI, USA. Electronic address: dkalmba1@hfhs.org.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Cheng', 'Affiliation': 'Thomas Roth Sleep Disorders & Research Center, Henry Ford Health System, Detroit, MI, USA.'}, {'ForeName': 'Louise M', 'Initials': 'LM', 'LastName': ""O'Brien"", 'Affiliation': 'Departments of Obstetrics & Gynecology and Neurology, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Leslie M', 'Initials': 'LM', 'LastName': 'Swanson', 'Affiliation': 'Department of Psychiatry, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Roopina', 'Initials': 'R', 'LastName': 'Sangha', 'Affiliation': 'Department of Obstetrics & Gynecology, Henry Ford Health System, Detroit, MI, USA.'}, {'ForeName': 'Srijan', 'Initials': 'S', 'LastName': 'Sen', 'Affiliation': 'Department of Psychiatry, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Constance', 'Initials': 'C', 'LastName': 'Guille', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, SC, USA.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Cuamatzi-Castelan', 'Affiliation': 'Thomas Roth Sleep Disorders & Research Center, Henry Ford Health System, Detroit, MI, USA.'}, {'ForeName': 'Alasdair L', 'Initials': 'AL', 'LastName': 'Henry', 'Affiliation': 'Big Health Inc, San Francisco, CA, USA; Sleep and Circadian Neuroscience Institute, Nuffield Department of Clinical Neurosciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Roth', 'Affiliation': 'Thomas Roth Sleep Disorders & Research Center, Henry Ford Health System, Detroit, MI, USA.'}, {'ForeName': 'Christopher L', 'Initials': 'CL', 'LastName': 'Drake', 'Affiliation': 'Thomas Roth Sleep Disorders & Research Center, Henry Ford Health System, Detroit, MI, USA.'}]",Sleep medicine,['10.1016/j.sleep.2020.03.016'] 1782,32559734,"Effects of low fructose diet on glycemic control, lipid profile and systemic inflammation in patients with type 2 diabetes: A single-blind randomized controlled trial.","BACKGROUND AND AIM Type 2 diabetes is one of the global epidemic disorders, which causes many side effects on the body. Fructose is a lipogenic monosaccharide. Recent studies have reported the adverse effects of this carbohydrate on diabetes. This study aimed to evaluate the clinical efficacy of a low-fructose diet on the metabolic alterations in patients with type 2 diabetes. METHODS This study was a randomized, single-blind clinical trial on 50 patients with type 2 diabetes. Participants randomly allocated to two groups, to receive either diabetic-diet or diabetic-diet with low-fructose for 8-weeks. Anthropometric measurements, systolic blood pressure (SBP), Diastolic blood pressure (DBP) and metabolic factors were assessed at baseline and the end of the trial. RESULTS At the end of trial, reduction in body weight, waist circumference, and blood pressure were not significant except for DBP (P = 0.013). Statistical analysis showed that low-fructose diet compared to control group significantly declined fasting blood glucose (FBG), Hemoglobin A1c (HbA1c), Triglyceride (TG), high-density lipoprotein-cholesterol (HDL-C) and high-sensitivity C-reactive protein (hs-CRP) (P = 0.015, P = 0.001, P=<0.0001, P= <0.0001 and P= <0.0001 respectively). CONCLUSION Our results showed that eight weeks of low-fructose diet results in a significant improvement in FBG, HbA1c, TG, HDL-C and hs-CRP in patients with type 2 diabetes.",2020,"At the end of trial, reduction in body weight, waist circumference, and blood pressure were not significant except for DBP (P = 0.013).","['50 patients with type 2 diabetes', 'patients with type 2 diabetes']","['diabetic-diet or diabetic-diet with low-fructose for 8-weeks', 'low-fructose diet', 'Fructose', 'low fructose diet']","['fasting blood glucose (FBG), Hemoglobin A1c (HbA1c), Triglyceride (TG), high-density lipoprotein-cholesterol (HDL-C) and high-sensitivity C-reactive protein (hs-CRP', 'Anthropometric measurements, systolic blood pressure (SBP), Diastolic blood pressure (DBP) and metabolic factors', 'glycemic control, lipid profile and systemic inflammation', 'body weight, waist circumference, and blood pressure', 'metabolic alterations', 'FBG, HbA1c, TG, HDL-C and hs-CRP']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0011878', 'cui_str': 'Diabetic diet'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0016745', 'cui_str': 'Fructose'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0452314', 'cui_str': 'Low fructose diet'}]","[{'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0023822', 'cui_str': 'HDL cholesterol'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}]",50.0,0.074236,"At the end of trial, reduction in body weight, waist circumference, and blood pressure were not significant except for DBP (P = 0.013).","[{'ForeName': 'Arman', 'Initials': 'A', 'LastName': 'Jalilvand', 'Affiliation': 'Department of Clinical Nutrition and Dietetics, National Nutrition and Food Technology Research Institute, Faculty of Nutrition Sciences and Food Technology, ShahidBeheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Vahideh', 'Initials': 'V', 'LastName': 'Behrouz', 'Affiliation': 'Department of Clinical Nutrition and Dietetics, National Nutrition and Food Technology Research Institute, Faculty of Nutrition Sciences and Food Technology, ShahidBeheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Omid', 'Initials': 'O', 'LastName': 'Nikpayam', 'Affiliation': 'Student Research Committee, Tabriz University of Medical Science, Tabriz, Iran; Department of Clinical Nutrition, Faculty of Nutrition and Food Science, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Golbon', 'Initials': 'G', 'LastName': 'Sohrab', 'Affiliation': 'Department of Clinical Nutrition and Dietetics, National Nutrition and Food Technology Research Institute, Faculty of Nutrition Sciences and Food Technology, ShahidBeheshti University of Medical Sciences, Tehran, Iran. Electronic address: golbonsohrab@yahoo.com.'}, {'ForeName': 'Azita', 'Initials': 'A', 'LastName': 'Hekmatdoost', 'Affiliation': 'Department of Clinical Nutrition and Dietetics, National Nutrition and Food Technology Research Institute, Faculty of Nutrition Sciences and Food Technology, ShahidBeheshti University of Medical Sciences, Tehran, Iran.'}]",Diabetes & metabolic syndrome,['10.1016/j.dsx.2020.04.003'] 1783,32559735,Improving clinical outcomes of diabetic foot ulcers by the 3-month self- and family management support programs in Indonesia: A randomized controlled trial study.,"BACKGROUND AND AIMS Diabetic foot ulcers are the leading cause of lower extremity amputations, which require more effective prevention. Even though previous nursing studies on diabetic foot ulcers have been well performed, programs implementing self- and family management are limited and even underexplored. Therefore, the purpose of the study was to investigate the effect of 3-month self- and family management support programs on clinical outcomes among Indonesians with diabetic foot ulcers. METHOD The randomized controlled trial design was used to answer the research question of the study. A total of 56 eligible participants were enrolled, with 27 in the experimental group and 29 in the control group. The experimental group received self- and family management support programs for three months. Meanwhile, the control group received usual care. Descriptive statistics, multivariate analysis of variance, and Generalized Estimating Equations were used to analyze the data. The significance level was considered at .05 for hypothesis testing. RESULTS The study showed that there were statistically significant improvements in self-management, family supports, hemoglobin A1c, and wound size after implemented the programs for three months (p < .05). CONCLUSIONS With regard to the result of the study, implementing the 3-month self- and family management support programs improves the patients' and families' abilities to perform diabetic foot ulcer care at home.",2020,"The study showed that there were statistically significant improvements in self-management, family supports, hemoglobin A1c, and wound size after implemented the programs for three months (p < .05). ","['A total of 56 eligible participants were enrolled, with 27 in the experimental group and 29 in the control group', 'Indonesia', 'Indonesians with diabetic foot ulcers']","['usual care', 'self- and family management support programs']","['self-management, family supports, hemoglobin A1c, and wound size']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0021247', 'cui_str': 'Indonesia'}, {'cui': 'C0021248', 'cui_str': 'Indonesian language'}, {'cui': 'C1456868', 'cui_str': 'Diabetic foot ulcer'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0150232', 'cui_str': 'Family support'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0456389', 'cui_str': 'Size'}]",56.0,0.0239313,"The study showed that there were statistically significant improvements in self-management, family supports, hemoglobin A1c, and wound size after implemented the programs for three months (p < .05). ","[{'ForeName': 'Sumarno Adi', 'Initials': 'SA', 'LastName': 'Subrata', 'Affiliation': 'Ramathibodi School of Nursing, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Thailand; Department of Nursing and Wound Research Center, Faculty of Health Sciences, Universitas Muhammadiyah Magelang, Indonesia.'}, {'ForeName': 'Rutja', 'Initials': 'R', 'LastName': 'Phuphaibul', 'Affiliation': 'Ramathibodi School of Nursing, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Thailand. Electronic address: ruja.phu@mahidol.ac.th.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Grey', 'Affiliation': 'Yale University School of Nursing, United States.'}, {'ForeName': 'Apinya', 'Initials': 'A', 'LastName': 'Siripitayakunkit', 'Affiliation': 'Ramathibodi School of Nursing, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Thailand.'}, {'ForeName': 'Noppawan', 'Initials': 'N', 'LastName': 'Piaseu', 'Affiliation': 'Ramathibodi School of Nursing, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Thailand.'}]",Diabetes & metabolic syndrome,['10.1016/j.dsx.2020.05.028'] 1784,32562206,Dabigatran Dual Therapy vs Warfarin Triple Therapy Post-Percutaneous Coronary Intervention in Patients with Atrial Fibrillation With/Without a Proton Pump Inhibitor: A Pre-Specified Analysis of the RE-DUAL PCI Trial.,"BACKGROUND AND OBJECTIVE In patients with atrial fibrillation following percutaneous coronary intervention, if a proton pump inhibitor is used, could that allow the use of warfarin triple therapy, or is there additional reduction in bleeding while using it with dual therapy? METHODS The RE-DUAL PCI trial randomized 2725 patients with atrial fibrillation post-percutaneous coronary intervention to dabigatran dual therapy (110 or 150 mg twice daily, with clopidogrel or ticagrelor) or warfarin triple therapy (with clopidogrel or ticagrelor, and aspirin for 1-3 months). This prespecified subgroup analysis evaluated risks of a first major bleeding event or clinically relevant non-major bleeding event, all gastrointestinal bleeding, and a composite efficacy endpoint of all-cause mortality/thromboembolic event or unplanned revascularization according to baseline use of a proton pump inhibitor. RESULTS Of 2678 analyzed patients, 1641 (61.3%) were receiving a proton pump inhibitor at baseline. Dabigatran 110 and 150 mg dual therapy reduced the risk of major bleeding events or clinically relevant non-major bleeding events vs warfarin triple therapy regardless of proton pump inhibitor use, with comparable risk of the composite efficacy endpoint (all interaction p values > 0.05). For gastrointestinal bleeding, no interaction was observed between study treatment and proton pump inhibitor use (interaction p values 0.84 and 0.62 for dabigatran 110 and 150 mg dual therapy, respectively, vs warfarin triple therapy). CONCLUSIONS Dabigatran 110 and 150 mg dual therapy reduced the risk of major bleeding events or clinically relevant non-major bleeding events vs warfarin triple therapy, regardless of proton pump inhibitor use at baseline, in patients with atrial fibrillation who underwent percutaneous coronary intervention. Risk of the composite efficacy endpoint appeared to be similar for dabigatran dual therapy vs warfarin triple therapy in patients receiving/not receiving a proton pump inhibitor. CLINICALTRIALS. GOV UNIQUE IDENTIFIER NCT02164864.",2020,"Dabigatran 110 and 150 mg dual therapy reduced the risk of major bleeding events or clinically relevant non-major bleeding events vs warfarin triple therapy regardless of proton pump inhibitor use, with comparable risk of the composite efficacy endpoint (all interaction p values > 0.05).","['patients with atrial fibrillation who underwent percutaneous coronary intervention', 'patients receiving/not receiving a proton pump inhibitor', 'Patients with Atrial Fibrillation', 'patients with atrial fibrillation following percutaneous coronary intervention', 'Of 2678 analyzed patients, 1641 (61.3%) were receiving a proton pump inhibitor at baseline', '2725 patients with atrial fibrillation post-percutaneous coronary intervention to']","['warfarin triple therapy', 'dabigatran dual therapy', 'Dabigatran', 'clopidogrel or ticagrelor', 'Proton Pump Inhibitor', 'warfarin triple therapy (with clopidogrel or ticagrelor, and aspirin', 'proton pump inhibitor', 'Dabigatran Dual Therapy vs Warfarin Triple Therapy Post-Percutaneous Coronary Intervention']","['risk of major bleeding events', 'risks of a first major bleeding event or clinically relevant non-major bleeding event, all gastrointestinal bleeding, and a composite efficacy endpoint of all-cause mortality/thromboembolic event or unplanned revascularization']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0358591', 'cui_str': 'H+/K+-exchanging ATPase inhibitor'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0687676', 'cui_str': 'After values'}]","[{'cui': 'C0043031', 'cui_str': 'Warfarin'}, {'cui': 'C0205174', 'cui_str': 'Triple'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C2348066', 'cui_str': 'dabigatran'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C0358591', 'cui_str': 'H+/K+-exchanging ATPase inhibitor'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0017181', 'cui_str': 'Gastrointestinal hemorrhage'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0040038', 'cui_str': 'Thromboembolus'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}]",2725.0,0.0706981,"Dabigatran 110 and 150 mg dual therapy reduced the risk of major bleeding events or clinically relevant non-major bleeding events vs warfarin triple therapy regardless of proton pump inhibitor use, with comparable risk of the composite efficacy endpoint (all interaction p values > 0.05).","[{'ForeName': 'José C', 'Initials': 'JC', 'LastName': 'Nicolau', 'Affiliation': 'Instituto do Coracao (InCor), Hospital das Clínicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Enéas Carvalho Aguiar, 44, Sao Paulo, SP, 05403-000, Brazil. jose.nicolau@incor.usp.br.'}, {'ForeName': 'Deepak L', 'Initials': 'DL', 'LastName': 'Bhatt', 'Affiliation': ""Brigham and Women's Hospital and Heart and Vascular Center, and Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Stefan H', 'Initials': 'SH', 'LastName': 'Hohnloser', 'Affiliation': 'Johann Wolfgang Goethe University, Frankfurt am Main, Germany.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Kimura', 'Affiliation': 'Kyoto University, Kyoto, Japan.'}, {'ForeName': 'Gregory Y H', 'Initials': 'GYH', 'LastName': 'Lip', 'Affiliation': 'Liverpool Centre for Cardiovascular Science, University of Liverpool and Liverpool Heart and Chest Hospital, Liverpool, UK.'}, {'ForeName': 'Corinna', 'Initials': 'C', 'LastName': 'Miede', 'Affiliation': 'Mainanalytics ma GmbH, Sulzbach (Taunus), Germany.'}, {'ForeName': 'Matias', 'Initials': 'M', 'LastName': 'Nordaby', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim am Rhein, Germany.'}, {'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'Oldgren', 'Affiliation': 'Uppsala Clinical Research Center, and Department of Medical Sciences, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Philippe Gabriel', 'Initials': 'PG', 'LastName': 'Steg', 'Affiliation': 'Université de Paris, FACT, INSERM U_1148, Paris, France.'}, {'ForeName': 'Jurriën M', 'Initials': 'JM', 'LastName': 'Ten Berg', 'Affiliation': 'St. Antonius Ziekenhuis, Nieuwegein, the Netherlands.'}, {'ForeName': 'Lucas C', 'Initials': 'LC', 'LastName': 'Godoy', 'Affiliation': 'Instituto do Coracao (InCor), Hospital das Clínicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Enéas Carvalho Aguiar, 44, Sao Paulo, SP, 05403-000, Brazil.'}, {'ForeName': 'Christopher P', 'Initials': 'CP', 'LastName': 'Cannon', 'Affiliation': ""Brigham and Women's Hospital and Heart and Vascular Center, and Harvard Medical School, Boston, MA, USA.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Drugs,['10.1007/s40265-020-01323-x'] 1785,32562310,Impact of Phenol-Enriched Virgin Olive Oils on the Postprandial Levels of Circulating microRNAs Related to Cardiovascular Disease.,"SCOPE We investigate the postprandial modulation of cardiovascular-related microRNAs elicited by extra virgin olive oil (EVOOs) containing different levels of their own polyphenols. METHODS AND RESULTS It is randomized, postprandial, parallel, double-blind study. Twelve healthy participants consumed 30 mL of EVOO containing low (L-EVOO; 250 mg total phenols kg -1 of oil), medium (M-EVOO; 500 mg total phenols kg -1 of oil), and high (H-EVOO; 750 mg total phenols kg -1 of oil) enriched EVOOs. Postprandial plasma microRNAs levels are analyzed by real-time quantitative PCR. The results show that L-EVOO intake is associated with decreased let-7e-5p and miR-328a-3p levels and increased miR-17-5p and miR-20a-5p, concentrations. M-EVOO decreases plasma let-7e-5p and increases miR-17-5p, miR-20a-5p, and miR-192-5p levels. Finally, H-EVOO decreases let-7e-5p, miR-10a-5p, miR-21-5p, and miR-26b-5p levels. CONCLUSION During the postprandial state, the levels of let-7e-5p decrease with EVOO regardless of polyphenol content suggesting a general response to the fatty acid composition of EVOO or/and the presence of at least 250 mg polyphenol kg -1 olive oil. Moreover, the miR-17-92 cluster increases by low and medium polyphenol content suggesting a role in fatty acid metabolism and nutrient sensing. Thus, postprandial modulation of circulating microRNAs levels could be a potential mechanism for the cardiovascular benefits associated with EVOO intake.",2020,"M-EVOO decreased plasma let-7e-5p and increased miR-17-5p, miR-20a-5p and miR-192-5p levels.",['12 healthy participants'],"['consumed 30\xa0mL of EVOO containing Low (L-EVOO; 250\xa0mg total phenols/kg of oil), Medium (M-EVOO; 500\xa0mg total phenols/kg of oil) and high (H-EVOO; 750\xa0mg total phenols/kg of oil) polyphenol', 'Extra Virgin Olive oil (EVOOs', 'Phenol-Enriched Virgin Olive Oils', 'polyphenol/kg olive oil']","['let-7e-5p and miR-328a-3p levels and increased miR-17-5p and miR-20a-5p, concentrations', 'Plasma microRNAs levels', 'L-EVOO intake', 'H-EVOO decreased let-7e-5p, miR-10a-5p, miR-21-5p and miR-26b-5p levels', 'M-EVOO decreased plasma let-7e-5p and increased miR-17-5p, miR-20a-5p and miR-192-5p levels']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0031428', 'cui_str': 'Phenols'}, {'cui': 'C0028908', 'cui_str': 'Oil'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C4517868', 'cui_str': '750'}, {'cui': 'C0071649', 'cui_str': 'Polyphenol'}, {'cui': 'C0555061', 'cui_str': 'Virgin'}, {'cui': 'C0069449', 'cui_str': 'olive oil'}]","[{'cui': 'C0086562', 'cui_str': 'Energy Transfer, Linear'}, {'cui': 'C1101610', 'cui_str': 'MicroRNA'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C4517623', 'cui_str': '192'}]",12.0,0.125285,"M-EVOO decreased plasma let-7e-5p and increased miR-17-5p, miR-20a-5p and miR-192-5p levels.","[{'ForeName': 'Lidia', 'Initials': 'L', 'LastName': 'Daimiel', 'Affiliation': 'Nutritional Control of the Epigenome Group, Instituto Madrileño de Estudios, Avanzados (IMDEA) Food Institute, CEI UAM+CSIC, Madrid, 28049, Spain.'}, {'ForeName': 'Víctor', 'Initials': 'V', 'LastName': 'Micó', 'Affiliation': 'Nutritional Control of the Epigenome Group, Instituto Madrileño de Estudios, Avanzados (IMDEA) Food Institute, CEI UAM+CSIC, Madrid, 28049, Spain.'}, {'ForeName': 'Rosa M', 'Initials': 'RM', 'LastName': 'Valls', 'Affiliation': 'Functional Nutrition, Oxidation and Cardiovascular Disease Research Group, Universitat Rovira i Virgili, Hospital Universitari Sant Joan, EURECAT, Reus, 43204, Spain.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Pedret', 'Affiliation': 'Functional Nutrition, Oxidation and Cardiovascular Disease Research Group, Universitat Rovira i Virgili, Hospital Universitari Sant Joan, EURECAT, Reus, 43204, Spain.'}, {'ForeName': 'María José', 'Initials': 'MJ', 'LastName': 'Motilva', 'Affiliation': ""Food Technology Department, Agrotecnio Center, Escola Tècnica Superior d'Enginyeria Agrària, University of Lleida, Lleida, 25198, Spain.""}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Rubió', 'Affiliation': 'Instituto de Ciencias de la Vid y del Vino-ICVV, (CSIC-Consejo Superior de Investigaciones Científicas, Universidad de La Rioja, Gobierno de La Rioja), Finca La Grajera, Ctra. de Burgos Km. 6 (LO-20 - salida 13), Logroño, La Rioja, 26007, Spain.'}, {'ForeName': 'Montse', 'Initials': 'M', 'LastName': 'Fitó', 'Affiliation': 'Cardiovascular Risk and Nutrition (Regicor Study Group), Hospital del Mar Medical Research Institute (IMIM), 08003 Barcelona, Spain. CIBER de Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Institute of Health Carlos III, Madrid, 28029, Spain.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Farrás', 'Affiliation': 'Cardiovascular Risk and Nutrition (Regicor Study Group), Hospital del Mar Medical Research Institute (IMIM), 08003 Barcelona, Spain. CIBER de Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Institute of Health Carlos III, Madrid, 28029, Spain.'}, {'ForeName': 'María Isabel', 'Initials': 'MI', 'LastName': 'Covas', 'Affiliation': 'Cardiovascular Risk and Nutrition (Regicor Study Group), Hospital del Mar Medical Research Institute (IMIM), 08003 Barcelona, Spain. CIBER de Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Institute of Health Carlos III, Madrid, 28029, Spain.'}, {'ForeName': 'Rosa', 'Initials': 'R', 'LastName': 'Solá', 'Affiliation': 'Functional Nutrition, Oxidation and Cardiovascular Disease Research Group, Universitat Rovira i Virgili, Hospital Universitari Sant Joan, EURECAT, Reus, 43204, Spain.'}, {'ForeName': 'José M', 'Initials': 'JM', 'LastName': 'Ordovás', 'Affiliation': 'Nutritional Genomics and Epigenomics Group, Instituto Madrileño de Estudios Avanzados (IMDEA) Food Institute, CEI UAM+CSIC, Madrid, 28049, Spain.'}]",Molecular nutrition & food research,['10.1002/mnfr.202000049'] 1786,32538286,Effects of wearing a full body compression garment during recovery from an ultra-trail race.,"In sport disciplines with high levels of muscle damage such as an ultra-trail competition, full body compression garments (FBCG) may have an ergogenic effect during the recovery process. The aim of the study was to assess the influence of FBCG worn for 24 h immediately after a 107-km ultra-trail on delayed onset muscle soreness (DOMS), muscle damage, inflammatory and renal response. Thirty-two athletes (19 males and 13 females; VO 2peak : 54.1 ± 5.2 ml O2/kg/min) participated in the study. The following blood markers were analysed before, immediately after, at 24 and 48 h post-race: lactate dehydrogenase, creatine kinase, C-reactive protein and creatinine. The glomerular filtration rate was also calculated. Delayed onset muscle soreness was evaluated before, immediately after and at 24 h post-race. On arrival at the finishing line, athletes were randomised into one of two recovery groups (FBCG and control group). The results showed that wearing FBCG did not influence the evolution of any of the blood markers up to 48 h after the race ( p  > .05). However, FBCG group presented a lower increase in posterior leg DOMS (11.0 ± 46.2% vs 112.3 ± 170.4%, p  =   .03, d  =   0.8). Therefore, although FBCG is not useful for reducing muscle damage and inflammatory response after an ultra-trail race, its use may still be recommended as a recovery method to reduce muscle soreness. Trial registration: ClinicalTrials.gov identifier: NCT03990259. Highlights It was assessed the influence of full body compression garments (FBCG) worn for 24 h immediately after a 107-km ultra-trail on delayed onset muscle soreness (DOMS) and physiological parameters. No effect was observed of FBCG on muscle damage, inflammatory and renal function recovery. Lower increase in posterior leg DOMS was observed for FBCG group.",2020,The results showed that wearing FBCG did not influence the evolution of any of the blood markers up to 48 h after the race (p>0.05).,['Thirty-two athletes (19 males and 13 females; VO 2peak : 54.1 ± 5.2 ml O2/kg/min) participated in the study'],"['FBCG', 'Wearing a Full Body Compression Garment']","['glomerular filtration rate', 'delayed onset muscle soreness (DOMS), muscle damage, inflammatory and renal response', 'posterior leg DOMS', 'Delayed onset muscle soreness']","[{'cui': 'C0450357', 'cui_str': '32'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517790', 'cui_str': '5.2'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C2985539', 'cui_str': 'Compression garment'}]","[{'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0231528', 'cui_str': 'Muscle pain'}, {'cui': 'C0410158', 'cui_str': 'Muscle damage NOS'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}]",,0.0531844,The results showed that wearing FBCG did not influence the evolution of any of the blood markers up to 48 h after the race (p>0.05).,"[{'ForeName': 'Ignacio', 'Initials': 'I', 'LastName': 'Martínez-Navarro', 'Affiliation': 'Physical Education and Sports Department, University of Valencia, Valencia, Spain.'}, {'ForeName': 'Inma', 'Initials': 'I', 'LastName': 'Aparicio', 'Affiliation': 'Research Group in Sports Biomechanics (GIBD), Physical Education and Sports Department, University of Valencia, Valencia, Spain.'}, {'ForeName': 'Jose Ignacio', 'Initials': 'JI', 'LastName': 'Priego-Quesada', 'Affiliation': 'Research Group in Sports Biomechanics (GIBD), Physical Education and Sports Department, University of Valencia, Valencia, Spain.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Pérez-Soriano', 'Affiliation': 'Research Group in Sports Biomechanics (GIBD), Physical Education and Sports Department, University of Valencia, Valencia, Spain.'}, {'ForeName': 'Eladio', 'Initials': 'E', 'LastName': 'Collado', 'Affiliation': 'Faculty of Health Sciences, Jaume I University, Castellon, Spain.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Hernando', 'Affiliation': 'Department of Medicine, Jaume I University, Castellon, Spain.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Hernando', 'Affiliation': 'Sport Service, Jaume I University, Castellon, Spain.'}]",European journal of sport science,['10.1080/17461391.2020.1783369'] 1787,32540337,Consolidation cetuximab after concurrent triplet radiochemotherapy+cetuximab in patients with advanced head and neck cancer: A randomized phase II study.,"BACKGROUND AND PURPOSE Preclinical data suggest that cetuximab should be continued after end of concurrent radiotherapy+cetuximab due to its efficacy against residual tumor cells in the irradiated tumor bed. Based on this concept the phase II add-on cetuximab (AOC) study was designed. MATERIALS AND METHODS Altogether 63 patients with advanced head and neck cancer were treated with radiochemotherapy (70 Gy, cisplatin 40 mg/m 2 weekly) in combination with concurrent cetuximab (loading dose 400 mg/m 2 , then 250 mg/m 2 weekly). Thereafter patients were randomized to cetuximab consolidation (500 mg/m 2 biweekly × 6) or no further treatment. The primary endpoint was the 2-year locoregional control (LRC) rate. As translational research endpoints serum markers were analyzed before and during treatment and CT-based quantitative image analysis (radiomics) was performed. RESULTS Median follow-up was 24 months. The 2-year LRC rates were 67.9% and 67.7% in the treatment arms with and without consolidation cetuximab, respectively. Higher than median levels of three serum markers were negatively associated with the 2-year LRC rate in the overall patient cohort: Osteopontin, IL8 and FasL2 (p ≤ 0.05). A radiomics model consisting of two radiomics features could be built showing that higher entropy and higher complexity of tumor Hounsfield unit distribution indicates worse LRC (concordance index 0.66). No correlation was found between biological and imaging markers. CONCLUSIONS There was no evidence that consolidation cetuximab would improve the 2-year LRC rate. Prognostic biological and imaging markers could be identified for the overall patient cohort. Studies with larger patient numbers are needed to correlate biological and imaging markers.",2020,"Higher than median levels of three serum markers were negatively associated with the 2-year LRC rate in the overall patient cohort: Osteopontin, IL8 and FasL2 (p≤0.05).","['Altogether 63 patients with advanced head and neck cancer', 'patients with advanced head and neck cancer']","['radiochemotherapy + cetuximab', 'radiochemotherapy (70 Gy, cisplatin 40mg/m2 weekly) in combination with concurrent cetuximab', 'Consolidation cetuximab', 'radiotherapy + cetuximab', 'cetuximab consolidation']","['2-year LRC rates', '2-year LRC rate', '2-year locoregional control (LRC) rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0278996', 'cui_str': 'Malignant tumor of head and neck'}]","[{'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0995188', 'cui_str': 'cetuximab'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0521530', 'cui_str': 'Lung consolidation'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",63.0,0.0261113,"Higher than median levels of three serum markers were negatively associated with the 2-year LRC rate in the overall patient cohort: Osteopontin, IL8 and FasL2 (p≤0.05).","[{'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Riesterer', 'Affiliation': 'Department of Radiation Oncology, University Hospital Zurich, University of Zurich, Switzerland; Center for Radiation Oncology KSA-KSB, Cantonal Hospital Aarau, Switzerland. Electronic address: oliver.riesterer@ksa.ch.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Pruschy', 'Affiliation': 'Laboratory for Molecular Radiobiology, University of Zurich, Switzerland.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Bender', 'Affiliation': 'Laboratory for Molecular Radiobiology, University of Zurich, Switzerland.'}, {'ForeName': 'Ashish', 'Initials': 'A', 'LastName': 'Sharma', 'Affiliation': 'Laboratory for Molecular Radiobiology, University of Zurich, Switzerland.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Bogowicz', 'Affiliation': 'Department of Radiation Oncology, University Hospital Zurich, University of Zurich, Switzerland.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Tanadini-Lang', 'Affiliation': 'Department of Radiation Oncology, University Hospital Zurich, University of Zurich, Switzerland.'}, {'ForeName': 'Sonja', 'Initials': 'S', 'LastName': 'Stieb', 'Affiliation': 'Department of Radiation Oncology, University Hospital Zurich, University of Zurich, Switzerland.'}, {'ForeName': 'Kaja', 'Initials': 'K', 'LastName': 'Bertogg', 'Affiliation': 'Clinical Trials Center, University Hospital Zurich, University of Zurich, Switzerland.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Weber', 'Affiliation': 'Clinical Trials Center, University Hospital Zurich, University of Zurich, Switzerland.'}, {'ForeName': 'Kristian', 'Initials': 'K', 'LastName': 'Ikenberg', 'Affiliation': 'Institute of Pathology and Molecular Pathology, University Hospital Zurich, University of Zurich, Switzerland.'}, {'ForeName': 'Gerhard', 'Initials': 'G', 'LastName': 'Huber', 'Affiliation': 'Department of Otorhinolaryngology, University Hospital Zurich, University of Zurich, Switzerland; Department of Otorhinolaryngology, Cantonal Hospital St. Gallen, Switzerland.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Schmid', 'Affiliation': 'Otorhinolaryngology Clinic Bethanien, Zurich, Switzerland.'}, {'ForeName': 'Marius', 'Initials': 'M', 'LastName': 'Bredell', 'Affiliation': 'Clinic for Oral and Maxillofacial Surgery, University Hospital Zurich, University of Zurich, Switzerland.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Veit-Haibach', 'Affiliation': 'Department of Nuclear Medicine, University Hospital Zurich, Switzerland; Department of Diagnostic and Interventional Radiology, University Hospital Zurich, University of Zurich, Switzerland.'}, {'ForeName': 'Tamara', 'Initials': 'T', 'LastName': 'Rordorf', 'Affiliation': 'Department of Medical Oncology, University Hospital Zurich, University of Zurich, Switzerland.'}, {'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'Held', 'Affiliation': 'Epidemiology, Biostatistics and Prevention Institute, Department of Biostatistics, University of Zurich, Switzerland.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Glanzmann', 'Affiliation': 'Department of Radiation Oncology, University Hospital Zurich, University of Zurich, Switzerland; Department of Radiation Oncology, Cantonal Hospital Lucerne, Switzerland.'}, {'ForeName': 'Gabriela', 'Initials': 'G', 'LastName': 'Studer', 'Affiliation': 'Department of Radiation Oncology, University Hospital Zurich, University of Zurich, Switzerland; Department of Radiation Oncology, Cantonal Hospital Lucerne, Switzerland.'}]",Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology,['10.1016/j.radonc.2020.06.011'] 1788,32540838,COVID-19 Modifications for Remote Teleassessment and Teletraining of a Complementary Alternative Medicine Intervention for People With Multiple Sclerosis: Protocol for a Randomized Controlled Trial.,"BACKGROUND Access to comprehensive exercise and rehabilitation services for people with multiple sclerosis (MS) remains a major challenge, especially in rural, low-income areas. Hence, the Tele-Exercise and Multiple Sclerosis (TEAMS) study aims to provide patient-centered, coordinated care by implementing a 12-week complementary and alternative medicine (CAM) intervention for adults with MS. However, due to the societal impact of coronavirus disease (COVID-19) in mid-March 2020, the University of Alabama at Birmingham announced a limited business model halting all nonessential research requiring on-site visits, which includes the TEAMS study. OBJECTIVE In compliance with the shelter-in-place policy and quarantine guidance, a modified testing and training protocol was developed to allow participants to continue the study. METHODS The modified protocol, which replaces on-site data collection and training procedures, includes a teleassessment package (computer tablet, blood pressure cuff, hand dynamometer, mini disc cone, measuring tape, an 8"" step, and a large-print 8"" × 11"" paper with ruler metrics and wall-safe tape) and a virtual meeting platform for synchronous interactive training between the therapist and the participant. The teleassessment measures include resting blood pressure and heart rate, grip strength, Five Times Sit to Stand, Timed Up & Go, and the Berg Balance Scale. The teletraining component includes 20 sessions of synchronous training sessions of dual tasking, yoga, and Pilates exercises designed and customized for a range of functional levels. Teletraining lasts 12 weeks and participants are instructed to continue exercising for a posttraining period of 9 months. RESULTS The protocol modifications were supported with supplemental funding (from the Patient-Centered Outcomes Research Institute) and approved by the University Institutional Review Board for Human Use. At the time nonessential research visits were halted by the university, there were 759 people enrolled and baseline tested, accounting for 92.5% of our baseline testing completion target (N=820). Specifically, 325 participants completed the 12-week intervention and follow-up testing visits, and 289 participants needed to complete either the intervention or follow-up assessments. A modified analysis plan will include sensitivity analyses to ensure the robustness of the study results in the presence of uncertainty and protocol deviations. Study results are projected to be published in 2021. CONCLUSIONS This modified remote teleassessment/teletraining protocol will impact a large number of participants with MS who would otherwise have been discontinued from the study. TRIAL REGISTRATION ClinicalTrials.gov NCT03117881; https://clinicaltrials.gov/ct2/show/NCT03117881. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID) DERR1-10.2196/18415.",2020,A modified analysis plan will include sensitivity analyses to ensure the robustness of the study results in presence of uncertainty and protocol deviations.,"['325 participants completed the 12-week intervention and follow-up testing visits, and 289 participants needed to complete either the intervention or follow-up assessments', 'participants with MS who would otherwise have discontinued the study', '759 people enrolled and baseline tested in the study (92.5% of our baseline testing completion target: 820', 'people with multiple sclerosis (MS', 'people with multiple sclerosis', 'adults with MS']","['synchronous training sessions of dual tasking, yoga, and Pilates exercises designed and customized', 'comprehensive exercise/rehabilitation services', 'alternative medicine (CAM) intervention', 'teleassessment package (laptop computer, blood pressure cuff, hand dynamometer, mini- disc cone, measuring tape, an 8"" step, and a large print 8""x11"" paper with ruler metrics and wall-safe tape) and virtual meeting platform for synchronous interactive training between therapist and participant']","['resting blood pressure and heart rate, the Hand-Grip Strength Test; Five Times Sit to Stand test; Timed Up & Go test; and Berg Balance Scale']","[{'cui': 'C4517714', 'cui_str': '325'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0439580', 'cui_str': 'Synchronous'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0587660', 'cui_str': 'Rehabilitation service'}, {'cui': 'C0002346', 'cui_str': 'Medicine, Alternative'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0013194', 'cui_str': 'Packaging, Drug'}, {'cui': 'C1737642', 'cui_str': 'Laptop computer'}, {'cui': 'C0180208', 'cui_str': 'Blood pressure cuff'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0180572', 'cui_str': 'Dynamometer'}, {'cui': 'C3881002', 'cui_str': 'Mini disc'}, {'cui': 'C0206428', 'cui_str': 'Cone of retina'}, {'cui': 'C0336570', 'cui_str': 'Measuring tape'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0033161', 'cui_str': 'Printing'}, {'cui': 'C0030351', 'cui_str': 'Paper'}, {'cui': 'C0522637', 'cui_str': 'Measuring ruler'}, {'cui': 'C0699680', 'cui_str': 'Metric'}, {'cui': 'C0205380', 'cui_str': 'Walled'}, {'cui': 'C0343138', 'cui_str': 'Strapping procedure'}, {'cui': 'C0556656', 'cui_str': 'Meetings'}]","[{'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C1293900', 'cui_str': 'Hand grip'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0560801', 'cui_str': 'Does stand from sitting'}, {'cui': 'C1998325', 'cui_str': 'Berg balance scale'}]",759.0,0.0382581,A modified analysis plan will include sensitivity analyses to ensure the robustness of the study results in presence of uncertainty and protocol deviations.,"[{'ForeName': 'Byron', 'Initials': 'B', 'LastName': 'Lai', 'Affiliation': 'Division of Pediatric Rehabilitation Medicine, School of Medicine, University of Alabama at Birmingham, Birmingham, AL, United States.'}, {'ForeName': 'Chia-Ying', 'Initials': 'CY', 'LastName': 'Chiu', 'Affiliation': 'Department of Health Services Administration, School of Health Professions, University of Alabama at Birmingham, Birmingham, AL, United States.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Pounds', 'Affiliation': ""Dean's Office, School of Health Professions, University of Alabama at Birmingham, Birmingham, AL, United States.""}, {'ForeName': 'Tracy', 'Initials': 'T', 'LastName': 'Tracy', 'Affiliation': 'Tanner Foundation, Birmingham, AL, United States.'}, {'ForeName': 'Tapan', 'Initials': 'T', 'LastName': 'Mehta', 'Affiliation': 'Department of Health Services Administration, School of Health Professions, University of Alabama at Birmingham, Birmingham, AL, United States.'}, {'ForeName': 'Hui-Ju', 'Initials': 'HJ', 'LastName': 'Young', 'Affiliation': 'Department of Physical Therapy, School of Health Professions, University of Alabama at Birmingham, Birmingham, AL, United States.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Riser', 'Affiliation': 'Tanner Foundation, Birmingham, AL, United States.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Rimmer', 'Affiliation': ""Dean's Office, School of Health Professions, University of Alabama at Birmingham, Birmingham, AL, United States.""}]",JMIR research protocols,['10.2196/18415'] 1789,32541288,Cost of Elective Labor Induction Compared With Expectant Management in Nulliparous Women.,"OBJECTIVE To compare the actual health-system cost of elective labor induction at 39 weeks of gestation with expectant management. METHODS This was an economic analysis of patients enrolled in the five Utah hospitals participating in a multicenter randomized trial of elective labor induction at 39 weeks of gestation compared with expectant management in low-risk nulliparous women. The entire trial enrolled more than 6,000 patients. For this subset, 1,201 had cost data available. The primary outcome was relative direct health care costs of maternal and neonatal care from a health system perspective. Secondary outcomes included the costs of each phase of maternal and neonatal care. Direct health system costs of maternal and neonatal care were measured using advanced costing analytics from the time of randomization at 38 weeks of gestation until exit from the study up to 8 weeks postpartum. Costs in each randomization arm were compared using generalized linear models and reported as the relative cost of induction compared with expectant management. With a fixed sample size, we had adequate power to detect a 7.3% or greater difference in overall costs. RESULTS The total cost of elective induction was no different than expectant management (mean difference +4.7%; 95% CI -2.1% to +12.0%; P=.18). Maternal outpatient antenatal care costs were 47.0% lower in the induction arm (95% CI -58.3% to -32.6%; P<.001). Maternal inpatient intrapartum and delivery care costs, conversely, were 16.9% higher among women undergoing labor induction (95% CI +5.5% to +29.5%; P=.003). Maternal inpatient postpartum care, maternal outpatient care after discharge, neonatal hospital care, and neonatal care after discharge did not differ between arms. CONCLUSION Total costs of elective labor induction and expectant management did not differ significantly. These results challenge the assumption that elective induction of labor leads to significant cost escalation.",2020,Maternal outpatient antenatal care costs were 47.0% lower in the induction arm (95% CI -58.3% to -32.6%; P<.001).,"['low-risk nulliparous women', 'patients enrolled in the five Utah hospitals participating', '6,000 patients', 'Nulliparous Women']","['Expectant Management', 'elective labor induction', 'expectant management']","['Maternal outpatient antenatal care costs', 'total cost of elective induction', 'Maternal inpatient postpartum care, maternal outpatient care after discharge, neonatal hospital care, and neonatal care after discharge', 'costs of each phase of maternal and neonatal care', 'overall costs', 'Cost of Elective Labor Induction', 'relative direct health care costs of maternal and neonatal care from a health system perspective', 'Maternal inpatient intrapartum and delivery care costs']","[{'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0425979', 'cui_str': 'Nulliparous'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0042124', 'cui_str': 'Utah'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0700325', 'cui_str': 'Patient status observation'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0259787', 'cui_str': 'Induction of labor'}]","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0032782', 'cui_str': 'Postpartum care'}, {'cui': 'C0002423', 'cui_str': 'Outpatient Care'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0001758', 'cui_str': 'Aftercare'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0259787', 'cui_str': 'Induction of labor'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0085552', 'cui_str': 'Health Costs'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0456337', 'cui_str': 'Intrapartum'}, {'cui': 'C1171257', 'cui_str': 'Delivery care'}]",,0.122938,Maternal outpatient antenatal care costs were 47.0% lower in the induction arm (95% CI -58.3% to -32.6%; P<.001).,"[{'ForeName': 'Brett D', 'Initials': 'BD', 'LastName': 'Einerson', 'Affiliation': 'Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, and the Division of Epidemiology, Department of Internal Medicine, University of Utah Health, Intermountain Healthcare, and the IDEAS Center, VA Salt Lake City Healthcare System, Salt Lake City, Utah; George Washington University Biostatistics Center, Washington, DC; the Division of Maternal Fetal Medicine, Department of Obstetrics and Gynecology, Northwestern University, Chicago, Illinois; and the Eunice Kennedy Shriver National Institute of Child Health and Human Development, Bethesda, Maryland.'}, {'ForeName': 'Richard E', 'Initials': 'RE', 'LastName': 'Nelson', 'Affiliation': ''}, {'ForeName': 'Grecio', 'Initials': 'G', 'LastName': 'Sandoval', 'Affiliation': ''}, {'ForeName': 'M Sean', 'Initials': 'MS', 'LastName': 'Esplin', 'Affiliation': ''}, {'ForeName': 'D Ware', 'Initials': 'DW', 'LastName': 'Branch', 'Affiliation': ''}, {'ForeName': 'Torri D', 'Initials': 'TD', 'LastName': 'Metz', 'Affiliation': ''}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Silver', 'Affiliation': ''}, {'ForeName': 'William A', 'Initials': 'WA', 'LastName': 'Grobman', 'Affiliation': ''}, {'ForeName': 'Uma M', 'Initials': 'UM', 'LastName': 'Reddy', 'Affiliation': ''}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Varner', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Obstetrics and gynecology,['10.1097/AOG.0000000000003930'] 1790,32541480,Systematic training program for nursing home staff based on the concept of combination of medicine and care.,"It is important to improve the training for nursing home staff in order to achieve better quality of life for the elderly.This study aimed to develop a systematic training program for nursing home staff based on the concept of combination of medicine and care.Thirty-four nursing staff from 2 representative nursing homes in Qiqihar City were selected as study subjects and divided into experimental and control groups. The subjects in both groups received routine training following ""National Occupational Standards of Elderly Nursing Staff"". In addition, the subjects in experimental groups received systematic training at three levels based on the concept of combination of medicine and care for 4 months.After the training, the competence scores of nursing staff in experimental group increased significantly compared to control group, the living quality of the elderly in nursing homes cared by nursing staff in experimental group was significantly improved, and the satisfaction of the elderly to nursing staff in experimental group improved significantly, compared to control group (P < .05).We develop systematic training program for nursing home staff based on the concept of combination of medicine and care, which can improve nursing care for the elderly in nursing home.",2020,"After the training, the competence scores of nursing staff in experimental group increased significantly compared to control group, the living quality of the elderly in nursing homes cared by nursing staff in experimental group was significantly improved, and the satisfaction of the elderly to nursing staff in experimental group improved significantly, compared to control group (P < .05).We develop systematic training program for nursing home staff based on the concept of combination of medicine and care, which can improve nursing care for the elderly in nursing home.",['Thirty-four nursing staff from 2 representative nursing homes in Qiqihar City'],"['routine training', 'systematic training']","['satisfaction of the elderly to nursing staff', 'competence scores of nursing staff', 'living quality']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0028698', 'cui_str': 'Nursing Staffs'}, {'cui': 'C0028688', 'cui_str': 'Long term care facility'}, {'cui': 'C0008848', 'cui_str': 'Cities'}]","[{'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0008902', 'cui_str': 'Classification'}]","[{'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0028698', 'cui_str': 'Nursing Staffs'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0332306', 'cui_str': 'Quality'}]",,0.00933714,"After the training, the competence scores of nursing staff in experimental group increased significantly compared to control group, the living quality of the elderly in nursing homes cared by nursing staff in experimental group was significantly improved, and the satisfaction of the elderly to nursing staff in experimental group improved significantly, compared to control group (P < .05).We develop systematic training program for nursing home staff based on the concept of combination of medicine and care, which can improve nursing care for the elderly in nursing home.","[{'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Department of Nursing.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'The First Hospital of Qiqihar, Heilongjiang, PR China.'}, {'ForeName': 'Liu', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': 'Department of Nursing.'}, {'ForeName': 'Chunhua', 'Initials': 'C', 'LastName': 'Qian', 'Affiliation': 'Department of Nursing.'}, {'ForeName': 'Dongmei', 'Initials': 'D', 'LastName': 'Sun', 'Affiliation': 'Department of Nursing.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'Department of Nursing.'}]",Medicine,['10.1097/MD.0000000000020559'] 1791,32541498,Intravenous versus topical tranexamic acid in lumbar interbody fusion: A protocol of randomized controlled trial.,"BACKGROUND Questions still remain about the safest and most effective route of administration for tranexamic acid (TXA) in lumbar interbody fusion. As such, the goal of this randomized clinical trial was to assess the efficacy and safety of topical TXA compared with intravenous TXA in lumbar interbody fusion. METHODS This was a prospectively randomized trial that investigated the effectiveness and safety of the intravenous and topical administrations of TXA with regard to lumbar interbody fusion. Approval from Clinical Studies Ethical Committee in our hospital was obtained. The patients were randomized to 1 of 2 treatment options:Patients, surgeons, anesthesiologists, nurses, and research assistants collecting data were blinded to group allocation. The primary outcome measures were perioperative calculated blood loss, total drain output at 24 hours, and perioperative blood transfusion rate. Secondary outcomes included an analysis of complications, namely symptomatic venous thromboembolism, cerebrovascular accident, and arterio-occlusive events. Data were analyzed using the statistical software package SPSS version 25.0 (Chicago, IL). RESULTS There are several limitations to this study. We did not include a group of patients who did not receive TXA. Another potential limitation is that the study population contains heterogeneity such as varying patient diagnosis and surgical technique/approach. Despite these limitations, the validity of our results should be maintained, as the same methodology was applied to both treatment arms. TRIAL REGISTRATION This study protocol was registered in Research Registry (researchregistry5564).",2020,"BACKGROUND Questions still remain about the safest and most effective route of administration for tranexamic acid (TXA) in lumbar interbody fusion.",['lumbar interbody fusion'],"['tranexamic acid (TXA', 'TXA', 'topical TXA', 'intravenous TXA', 'topical tranexamic acid']","['efficacy and safety', 'perioperative calculated blood loss, total drain output at 24\u200ahours, and perioperative blood transfusion rate', 'analysis of complications, namely symptomatic venous thromboembolism, cerebrovascular accident, and arterio-occlusive events', 'effectiveness and safety']","[{'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C0332466', 'cui_str': 'Fusion'}]","[{'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0013103', 'cui_str': 'Drainage procedure'}, {'cui': 'C3251815', 'cui_str': 'Measurement of fluid output'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C1861172', 'cui_str': 'Thromboembolism, Venous'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C1947917', 'cui_str': 'Occluded'}, {'cui': 'C0441471', 'cui_str': 'Event'}]",,0.278037,"BACKGROUND Questions still remain about the safest and most effective route of administration for tranexamic acid (TXA) in lumbar interbody fusion.","[{'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Song', 'Affiliation': ""Department of Orthopedics, People's Hospital of Nanchuan District, Chongqing, China.""}, {'ForeName': 'Zhouhai', 'Initials': 'Z', 'LastName': 'Zheng', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000020619'] 1792,32541504,The efficacy of ketamine in total knee arthroplasty: a randomized controlled trial protocol.,"BACKGROUND Appropriate pain management is essential to improve the postoperative recovery after total knee arthroplasty (TKA). There is a paucity of literature on ketamine for TKA procedures. The aim of this study was to evaluate the analgesic efficacy of ketamine in patients undergoing primary TKA. METHODS This study was designed as a prospective, double blind, single center, randomized controlled trial. The participants were randomly assigned to either the ketamine or placebo groups, using a set of random numbers for the allocation sequence. All patients underwent TKA without patella resurfacing under spinal anesthesia. Preoperative workup, surgical technique, and postoperative management were standardized for all the patients. The primary outcome of this noninferiority study is opioid consumption within the first 24 hours following surgery, pain scores, distance ambulated, patient satisfaction, length of hospital stay, and complications. RESULTS The results of this study were expected to provide useful information on the effectiveness and safety of ketamine for immediate postoperative analgesia after TKA surgery. TRIAL REGISTRATION This study protocol was registered in Research Registry (researchregistry5575).",2020,"The results of this study were expected to provide useful information on the effectiveness and safety of ketamine for immediate postoperative analgesia after TKA surgery. ","['total knee arthroplasty', 'total knee arthroplasty (TKA', 'patients undergoing primary TKA']","['TKA without patella resurfacing under spinal anesthesia', 'ketamine or placebo', 'ketamine']","['analgesic efficacy', 'opioid consumption within the first 24\u200ahours following surgery, pain scores, distance ambulated, patient satisfaction, length of hospital stay, and complications']","[{'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205225', 'cui_str': 'Principal'}]","[{'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0030647', 'cui_str': 'Bone structure of patella'}, {'cui': 'C0002928', 'cui_str': 'Spinal anesthesia'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",,0.488923,"The results of this study were expected to provide useful information on the effectiveness and safety of ketamine for immediate postoperative analgesia after TKA surgery. ","[{'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Department of Orthopedics, Aerospace Center Hospital, Beijing.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Hu', 'Affiliation': 'Department of Orthopedics, Ningxia Armed Police Corps Hospital, Ningxia Hui Autonomous Region.'}, {'ForeName': 'Shu-Ming', 'Initials': 'SM', 'LastName': 'Li', 'Affiliation': 'Department of Orthopedics, Aerospace Center Hospital, Beijing.'}, {'ForeName': 'Xiao-Lin', 'Initials': 'XL', 'LastName': 'Li', 'Affiliation': 'Department of Orthopedics, Ningxia Armed Police Corps Hospital, Ningxia Hui Autonomous Region.'}, {'ForeName': 'Zhan-Min', 'Initials': 'ZM', 'LastName': 'Yang', 'Affiliation': 'Department of Anesthesiology, Aerospace Center Hospital, Beijing, China.'}]",Medicine,['10.1097/MD.0000000000020645'] 1793,32541510,A randomized controlled study for Yuanhu Zhitong dropping pills in the treatment of knee osteoarthritis.,"BACKGROUND Knee osteoarthritis (KOA) is a common chronic disorder of knee and the leading cause of pain in the elderly with an overall prevalence of 50% in people over 60 years of age. This disease is an important factor affecting the quality of life of middle-aged and elderly people, and its main symptom is knee joint pain. Due to the pain, the knee joint activity function is limited, bringing great pain to patients, affecting their quality of life, effective prevention, and treatment of KOA is a modern medical problem. METHODS The 60 patients who met the inclusion criteria were randomly divided into the treatment group and the control group. In this study, single center, randomized control and equivalent clinical trial were used for treatment. The treatment group received Yuanhu Zhitong dropping pills within 4 weeks, and the control group received diclofenac sodium sustained-release capsule treatment within 4 weeks. The main measures were visual analogue scale (VAS), WOMAC osteoarthritis index score and gastrointestinal symptoms rating scale (GSRS).Secondary measures included biochemical markers and adverse reactions during treatment. RESULT The results of this trial will be published on the website of China Clinical Trial Registration Center (http://www.chictr.org.cn/searchprojen.aspx) and in peer-reviewed journals or academic conferences. CONCLUSIONS This study is to assess the efficacy and safety of Yuanhu Zhitong dropping pills for knee osteoarthritis (KOA). REGISTRATION PROSPERO (registration number ChiCTR1900024712).",2020,"The main measures were visual analogue scale (VAS), WOMAC osteoarthritis index score and gastrointestinal symptoms rating scale (GSRS).Secondary measures included biochemical markers and adverse reactions during treatment. ","['knee osteoarthritis', 'elderly with an overall prevalence of 50% in people over 60 years of age', '60 patients who met the inclusion criteria', 'knee osteoarthritis (KOA']","['Yuanhu Zhitong dropping pills', 'diclofenac sodium sustained-release capsule treatment']","['visual analogue scale (VAS), WOMAC osteoarthritis index score and gastrointestinal symptoms rating scale (GSRS).Secondary measures included biochemical markers and adverse reactions', 'efficacy and safety']","[{'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C3885247', 'cui_str': 'yuanhu zhitong'}, {'cui': 'C0440421', 'cui_str': 'Droppings'}, {'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}, {'cui': 'C0700583', 'cui_str': 'Diclofenac sodium'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0426576', 'cui_str': 'Gastrointestinal symptom'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0206015', 'cui_str': 'Biochemical Markers'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",60.0,0.0717213,"The main measures were visual analogue scale (VAS), WOMAC osteoarthritis index score and gastrointestinal symptoms rating scale (GSRS).Secondary measures included biochemical markers and adverse reactions during treatment. ","[{'ForeName': 'Yubiao', 'Initials': 'Y', 'LastName': 'Gu', 'Affiliation': 'Gansu Provincial Hospital of TCM.'}, {'ForeName': 'Jin', 'Initials': 'J', 'LastName': 'Huang', 'Affiliation': 'Gansu Provincial Hospital of TCM.'}, {'ForeName': 'Honggang', 'Initials': 'H', 'LastName': 'Guo', 'Affiliation': 'Gansu University of Chinese medicine.'}, {'ForeName': 'Xuewen', 'Initials': 'X', 'LastName': 'Song', 'Affiliation': 'Gansu University of Chinese medicine.'}, {'ForeName': 'Jianguo', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Gansu Provincial Hospital of TCM.'}, {'ForeName': 'Yanlong', 'Initials': 'Y', 'LastName': 'Shi', 'Affiliation': 'Gansu University of Chinese medicine.'}, {'ForeName': 'Xingwen', 'Initials': 'X', 'LastName': 'Xie', 'Affiliation': 'Department of Orthopaedics, Affiliated Hospital of Northwest Minzu University.'}]",Medicine,['10.1097/MD.0000000000020666'] 1794,32535138,The effects of foam roll on perceptual and performance recovery during a futsal tournament.,"The present study investigated the efficacy of recovery by foam rolling (FR) on performance, psychological, and physiological parameters of futsal players in a simulated futsal tournament. In this randomized controlled trial design, four youth teams from Iran's national premier league participated in a simulated futsal tournament (five days, three matches). Sixteen youth futsal players from two teams (age: 19.1 ± 1.3 years old) were randomly distributed into two groups: (i) passive recovery (PR); and (ii) FR recovery. The FR recovery protocol consisted of five repetitions of 40 s separated by 20 s of rest on calf, quadriceps, hamstrings, and gluteus muscles 5 min after each match. The other group rested passively during the same period. The Yo-Yo intermittent recovery level 2, repeated sprint ability, vertical jump, and PRO agility tests were assessed pre- and post-tournament. Also, Hooper index (HI) and blood lactate concentrations were measured throughout matchdays. Data were analyzed by a repeated measure ANOVA and ANCOVA. Substantial improvements in HI on the second (ES:0.6) and third (ES:0.4) matchdays and faster lactate removal on the third (ES:0.3) matchday were observed in the FR group when compared to the PR group (p<0.05). Although FR recovery was slightly beneficial when compared to PR attenuated decrements in aerobic (-1.6%vs-9.7%) and anaerobic performance (-4.5%vs-1.3%), vertical jump (-1.6%vs-3.0%), and change of direction (-2.1%vs-4.3%), these effects were not statistically significant (p>0.05). The finding showed using FR during compact competitions expedites physical performance recovery, increases blood lactate clearance and leads to regenerate psychological characteristics. Therefore, along with other desirable recovery strategies, the use of FR could be recommended in short-term compacted futsal tournaments.",2020,Substantial improvements in HI on the second (ES:0.6) and third (ES:0.4) matchdays and faster lactate removal on the third (ES:0.3) matchday were observed in the FR group when compared to the PR group (p<0.05).,"['Sixteen youth futsal players from two teams (age: 19.1±1.3 years old', ""four youth teams from Iran's national premier league participated in a simulated futsal tournament (five days, three matches"", 'futsal players in a simulated futsal tournament']","['passive recovery (PR); and (ii) FR recovery', 'foam rolling (FR', 'foam roll']","['Hooper index (HI) and blood lactate concentrations', 'perceptual and performance recovery', 'repeated sprint ability, vertical jump, and PRO agility tests', 'lactate removal', 'blood lactate clearance', 'anaerobic performance']","[{'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C1532535', 'cui_str': 'Indoor soccer'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0284447', 'cui_str': 'Simulate composite resin'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0336766', 'cui_str': 'Matches'}]","[{'cui': 'C0991510', 'cui_str': 'Foam'}]","[{'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}]",,0.0276004,Substantial improvements in HI on the second (ES:0.6) and third (ES:0.4) matchdays and faster lactate removal on the third (ES:0.3) matchday were observed in the FR group when compared to the PR group (p<0.05).,"[{'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Rahimi', 'Affiliation': 'Department of Exercise Physiology, Faculty of Physical Education and Sports Science, Kharazmi University, Tehran, Iran.'}, {'ForeName': 'Sadegh', 'Initials': 'S', 'LastName': 'Amani-Shalamzari', 'Affiliation': 'Department of Exercise Physiology, Faculty of Physical Education and Sports Science, Kharazmi University, Tehran, Iran.'}, {'ForeName': 'Filipe Manuel', 'Initials': 'FM', 'LastName': 'Clemente', 'Affiliation': ""Escola Superior Desporto e Lazer, Instituto Politécnico de Viana do Castelo, Rua Escola Industrial e Comercial de Nun'Álvares, 4900-347, Viana do Castelo, Portugal; Instituto de Telecomunicações, Delegação da Covilhã, Lisboa 1049-001, Portugal. Electronic address: filipeclemente@esdl.ipvc.pt.""}]",Physiology & behavior,['10.1016/j.physbeh.2020.112981'] 1795,32543382,Cost Saving of Short Hospitalization Nonoperative Management for Acute Uncomplicated Appendicitis.,"BACKGROUND Nonoperative management (NOM) of uncomplicated appendicitis has gained recognition as an alternative to surgery. In the largest published randomized trial (Appendicitis Acuta), patients received a 3-d hospital stay for intravenous antibiotics; however, cost implications for health care systems remain unknown. We hypothesized short stay protocols would be cost saving compared with a long stay protocol. MATERIALS AND METHODS We constructed a Markov model comparing the cost of three protocols for NOM of acute uncomplicated appendicitis: (1) long stay (3-d hospitalization), (2) short stay (1-d hospitalization), and (3) emergency department (ED) discharge. The long stay protocol was modeled on data from the APPAC trial. Model variables were abstracted from national database and literature review. One-way and two-way sensitivity analyses were performed to determine the impact of uncertainty on the model. RESULTS The long stay treatment protocol had a total 5-y projected cost of $10,735 per patient. The short stay treatment protocol costs $8026 per patient, and the ED discharge protocol costs $6,825, which was $2709 and $3910 less than the long stay protocol, respectively. One-way sensitivity analysis demonstrated that the relative risk of treatment failure with the short stay protocol needed to exceed 6.3 (absolute risk increase of 31%) and with the ED discharge protocol needed to exceed 8.75 (absolute risk increase of 45%) in order for the long stay protocol to become cost saving. CONCLUSIONS Short duration hospitalization protocols to treat appendicitis nonoperatively with antibiotics are cost saving under almost all model scenarios. Future consideration of patient preferences and health-related quality of life will need to be made to determine if short stay treatment protocols are cost-effective.",2020,"The short stay treatment protocol costs $8026 per patient, and the ED discharge protocol costs $6,825, which was $2709 and $3910 less than the long stay protocol, respectively.",['Acute Uncomplicated Appendicitis'],"['3-d hospital stay for intravenous antibiotics', 'Nonoperative management (NOM']","['ED discharge protocol costs', 'short stay treatment protocol costs', 'stay (3-d hospitalization), (2) short stay (1-d hospitalization), and (3) emergency department (ED) discharge', 'total 5-y projected cost']","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0443334', 'cui_str': 'Uncomplicated'}]","[{'cui': 'C0450363', 'cui_str': 'Three-dimensional'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0450363', 'cui_str': 'Three-dimensional'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0016538', 'cui_str': 'Projections and Predictions'}]",,0.0383425,"The short stay treatment protocol costs $8026 per patient, and the ED discharge protocol costs $6,825, which was $2709 and $3910 less than the long stay protocol, respectively.","[{'ForeName': 'Max A', 'Initials': 'MA', 'LastName': 'Schumm', 'Affiliation': 'Department of Surgery, UCLA David Geffen School of Medicine, Los Angeles, California. Electronic address: mschumm@mednet.ucla.edu.'}, {'ForeName': 'Christopher P', 'Initials': 'CP', 'LastName': 'Childers', 'Affiliation': 'Department of Surgery, UCLA David Geffen School of Medicine, Los Angeles, California.'}, {'ForeName': 'James X', 'Initials': 'JX', 'LastName': 'Wu', 'Affiliation': 'Department of Surgery, UCLA David Geffen School of Medicine, Los Angeles, California.'}, {'ForeName': 'Kyle A', 'Initials': 'KA', 'LastName': 'Zanocco', 'Affiliation': 'Department of Surgery, UCLA David Geffen School of Medicine, Los Angeles, California.'}]",The Journal of surgical research,['10.1016/j.jss.2020.05.028'] 1796,32543706,Recombinant Human BMP6 Applied Within Autologous Blood Coagulum Accelerates Bone Healing: Randomized Controlled Trial in High Tibial Osteotomy Patients.,"Bone morphogenetic proteins (BMPs) are potent osteogenic proteins that induce new bone formation in vivo. However, their effect on bone healing in the trabecular bone surfaces remains challenging. We evaluated the safety and efficacy of recombinant human BMP6 (rhBMP6) applied within an autologous blood coagulum (ABC) in a surgically created wedge defect of the proximal tibia in patients undergoing high tibial osteotomy (HTO) for Varus deformity and medial osteoarthritis of the knee. We enrolled 20 HTO patients in a randomized, placebo-controlled, double-blinded phase I/II clinical trial. RhBMP6/ABC (1.0 mg/10 mL ABC prepared from peripheral blood) or placebo (10 mL ABC containing excipients) was administered into the tibial wedge defects. Patients were followed for 0 to 24 months by clinical examination (safety) and computed tomography (CT) and serial radiographic analyses (efficacy). The results show that there were no detectable anti-rhBMP6 antibodies in the blood of any of the 20 patients at 14 weeks after implantation. During the 24 months of follow-up, there were no serious adverse reactions recorded. The CT scans from defects of patients treated with rhBMP6/ABC showed an accelerated bone healing compared with placebo at 9 weeks (47.8 ± 24.1 versus 22.2 ± 12.3 mg/cm 2 ; p = 0.008) and at 14 weeks (89.7 ± 29.1 versus 53.6 ± 21.9 mg/cm 2 ; p = 0.006) follow-up. Radiographic analyses at weeks 6 and 24 and months 12 and 24 suggested the advanced bone formation and remodeling in rhBMP6/ABC-treated patients. In conclusion, we show that rhBMP6/ABC at a dose of 100 μg/mL accelerated bone healing in patients undergoing HTO without serious adverse events and with a good tolerability compared with placebo alone. Overall, for the first time, a BMP-based osteogenic implant was examined against a placebo for bone healing efficacy in the trabecular bone surface, using an objective bone mineral density measurement system. © 2020 The Authors. Journal of Bone and Mineral Research published by American Society for Bone and Mineral Research.",2020,The results show that there were no detectable anti-rhBMP6 antibodies in the blood of any of the 20 patients at 14 weeks following implantation.,"['High Tibial Osteotomy patients', 'patients undergoing high tibial osteotomy (HTO) for Varus deformity and medial osteoarthritis of the knee', '20 HTO patients']","['Recombinant human BMP6', 'RhBMP6/ABC ', 'rhBMP6/ABC', 'recombinant human BMP6 (rhBMP6', 'placebo']","['accelerated bone healing', 'clinical examination (safety) and CT and serial radiographic analyses (efficacy', 'bone healing', 'detectable anti-rhBMP6 antibodies', 'advanced bone formation and remodelling']","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0187826', 'cui_str': 'Osteotomy of tibia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0432593', 'cui_str': 'Varus angulation'}, {'cui': 'C0205098', 'cui_str': 'Medial'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}]","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C1612225', 'cui_str': 'BMP6 protein, human'}, {'cui': 'C0302148', 'cui_str': 'Blood clot'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0521110', 'cui_str': 'Accelerated'}, {'cui': 'C1321023', 'cui_str': 'Bone healing status'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031082', 'cui_str': 'Periodicals'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C1612225', 'cui_str': 'BMP6 protein, human'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0029433', 'cui_str': 'Bone formation'}]",20.0,0.154535,The results show that there were no detectable anti-rhBMP6 antibodies in the blood of any of the 20 patients at 14 weeks following implantation.,"[{'ForeName': 'Catharina', 'Initials': 'C', 'LastName': 'Chiari', 'Affiliation': 'Department of Orthopedics and Trauma Surgery, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Lovorka', 'Initials': 'L', 'LastName': 'Grgurevic', 'Affiliation': 'Laboratory for Mineralized Tissues, Centre for Translational and Clinical Research, University of Zagreb School of Medicine, Zagreb, Croatia.'}, {'ForeName': 'Tatjana', 'Initials': 'T', 'LastName': 'Bordukalo-Niksic', 'Affiliation': 'Laboratory for Mineralized Tissues, Centre for Translational and Clinical Research, University of Zagreb School of Medicine, Zagreb, Croatia.'}, {'ForeName': 'Hermann', 'Initials': 'H', 'LastName': 'Oppermann', 'Affiliation': 'Genera Research, Rakov Potok, Croatia.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Valentinitsch', 'Affiliation': 'Department of Orthopedics and Trauma Surgery, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Nemecek', 'Affiliation': 'Department of Orthopedics and Trauma Surgery, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Staats', 'Affiliation': 'Department of Orthopedics and Trauma Surgery, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Schreiner', 'Affiliation': 'Department of Orthopedics and Trauma Surgery, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Trost', 'Affiliation': 'Department of Orthopedics and Trauma Surgery, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Kolb', 'Affiliation': 'Department of Orthopedics and Trauma Surgery, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Franz', 'Initials': 'F', 'LastName': 'Kainberger', 'Affiliation': 'Department of Orthopedics and Trauma Surgery, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Sanja', 'Initials': 'S', 'LastName': 'Pehar', 'Affiliation': 'Laboratory for Mineralized Tissues, Centre for Translational and Clinical Research, University of Zagreb School of Medicine, Zagreb, Croatia.'}, {'ForeName': 'Milan', 'Initials': 'M', 'LastName': 'Milosevic', 'Affiliation': 'Department of Environmental and Occupational Health and Sports, School of Public Health, ""Andrija Stampar,"", University of Zagreb School of Medicine, Zagreb, Croatia.'}, {'ForeName': 'Snjezana', 'Initials': 'S', 'LastName': 'Martinovic', 'Affiliation': 'SmartMedico, Zagreb, Croatia.'}, {'ForeName': 'Mihaela', 'Initials': 'M', 'LastName': 'Peric', 'Affiliation': 'Department for Intracellular Communication, Centre for Translational and Clinical Research, University of Zagreb School of Medicine, Zagreb, Croatia.'}, {'ForeName': 'T Kuber', 'Initials': 'TK', 'LastName': 'Sampath', 'Affiliation': 'perForm Biologics Inc., Holliston, MA, USA.'}, {'ForeName': 'Slobodan', 'Initials': 'S', 'LastName': 'Vukicevic', 'Affiliation': 'Laboratory for Mineralized Tissues, Centre for Translational and Clinical Research, University of Zagreb School of Medicine, Zagreb, Croatia.'}, {'ForeName': 'Reinhard', 'Initials': 'R', 'LastName': 'Windhager', 'Affiliation': 'Department of Orthopedics and Trauma Surgery, Medical University of Vienna, Vienna, Austria.'}]",Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research,['10.1002/jbmr.4107'] 1797,32535342,Food intake is associated with verbal interactions between nursing home staff and residents with dementia: A secondary analysis of videotaped observations.,"BACKGROUND Nursing home residents with dementia commonly experience low food intake, leading to negative functional and nutritional consequences. While the importance of staff-resident (dyadic) interactions during mealtime is acknowledged, little research has examined the role of dyadic verbal interactions on food intake. OBJECTIVES This study aimed to examine the relationship between food intake and dyadic verbal interactions. METHODS This study was a secondary analysis of 110 videotaped observations of mealtime care interactions among 25 residents with dementia and 29 staff (42 unique dyads) in 9 nursing homes. Staff positive utterances and resident positive and negative utterances (independent variables) and food intake (dependent variable) were coded from the videotaped observations using the Cue Utilization and Engagement in Dementia video coding scheme. A linear mixed model was fit to the data. The two-way interaction effects of food type and video duration with each independent variable as well as two-way interaction effects among the independent variables were tested. Covariates included in the model were the number of years staff worked as a caregiver, and resident age, gender, and eating function. RESULTS The model included three significant interaction effects involving verbal variables: the interaction effect of staff positive utterances with resident positive utterances (p=.030), the interaction effect of staff positive utterances with food type (p=.027), and the interaction effect of resident negative utterances with video duration (p=0.002). Increased number of intakes of liquid food per minute was associated with increased number of staff positive utterances per minute when residents did not make positive utterances. Decreased number of intakes of solid food per minute was associated with increased number of staff positive utterances per minute, especially when residents made between 0 and 3 positive utterances per minute. As the duration of the videos increased, the number of intakes per minute increased for residents who made one or more negative utterances and decreased for residents who made no negative utterances in the videos. The number of intakes per minute was associated with resident gender in that male residents had increased number of intakes per minute compared with female residents (p=.017), and was not associated with other participant characteristics. CONCLUSION Intake was associated with dyadic verbal interactions, and such relationship was complex in that it was moderated by food type and video duration. Findings support the significant role of dyadic verbal interactions on intake, and inform the development of effective, tailored mealtime care interventions to promote intake.",2020,"The number of intakes per minute was associated with resident gender in that male residents had increased number of intakes per minute compared with female residents (p=.017), and was not associated with other participant characteristics. ","['25 residents with dementia and 29 staff (42 unique dyads) in 9 nursing homes', 'nursing home staff and residents with dementia']",[],"['number of intakes per minute', 'dyadic verbal interactions', 'Staff positive utterances and resident positive and negative utterances (independent variables) and food intake', 'number of staff positive utterances']","[{'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0028688', 'cui_str': 'Long term care facility'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}]",[],"[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0702093', 'cui_str': '/minute'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0013470', 'cui_str': 'Eating'}]",110.0,0.0676015,"The number of intakes per minute was associated with resident gender in that male residents had increased number of intakes per minute compared with female residents (p=.017), and was not associated with other participant characteristics. ","[{'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Liu', 'Affiliation': 'The University of Iowa, College of Nursing, Iowa City, IA, USA. Electronic address: wen-liu-1@uiowa.edu.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Perkhounkova', 'Affiliation': 'The University of Iowa, College of Nursing, Iowa City, IA, USA.'}, {'ForeName': 'Kristine', 'Initials': 'K', 'LastName': 'Williams', 'Affiliation': 'The University of Kansas, School of Nursing, Kansas City, KS, USA.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Batchelor', 'Affiliation': 'George Washington University, School of Nursing, Washington, D.C., USA.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Hein', 'Affiliation': 'The University of Iowa, College of Nursing, Iowa City, IA, USA.'}]",International journal of nursing studies,['10.1016/j.ijnurstu.2020.103654'] 1798,32535407,An investigation of the impact of social exclusion on attachment to possessions and saving behaviors.,"BACKGROUND AND OBJECTIVES Hoarding disorder (HD) is a debilitating mental illness characterized by extreme difficulty parting with possessions and clutter that can result in dangerous living conditions. One hypothesis about why individuals with HD save possessions is that they possess a pathological attachment to their belongings, which may serve to compensate for unfulfilling interpersonal relationships. However, there is a dearth of empirical work examining this. The current study examined the impact of an experimental manipulation of social exclusion on attachment to possessions and saving behaviors in a sample of individuals with elevated hoarding symptoms. METHODS Participants (n = 117) were selected for scoring above the non-clinical mean on a measure of hoarding symptoms. Participants were randomized to either be included or excluded in a game of Cyberball. They completed a behavioral discarding task and object attachment measure before and after completion of the game. RESULTS Study condition was unrelated to in vivo attachment to possessions and saving behaviors during the discarding task. However, a post hoc mediation model showed that greater feelings of rejection, regardless of condition, were associated with greater in vivo attachment to possessions and subsequent number of items saved during the lab task. LIMITATIONS Limitations include the use of a non-clinical and homogeneous sample. CONCLUSIONS Taken together, individuals prone to feelings of rejection may be at risk for developing HD as they may use possessions to cope with interpersonal stress. Results will be discussed in light of implications for theoretical models and potential treatment targets in HD.",2020,"However, a post hoc mediation model showed that greater feelings of rejection, regardless of condition, were associated with greater in vivo attachment to possessions and subsequent number of items saved during the lab task. ","['individuals with elevated hoarding symptoms', 'Participants (n\xa0=\xa0117']",[],[],"[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",[],[],117.0,0.034374,"However, a post hoc mediation model showed that greater feelings of rejection, regardless of condition, were associated with greater in vivo attachment to possessions and subsequent number of items saved during the lab task. ","[{'ForeName': 'Brittany M', 'Initials': 'BM', 'LastName': 'Mathes', 'Affiliation': 'Florida State University, United States.'}, {'ForeName': 'Norman B', 'Initials': 'NB', 'LastName': 'Schmidt', 'Affiliation': 'Florida State University, United States. Electronic address: schmidt@psy.fsu.edu.'}]",Journal of behavior therapy and experimental psychiatry,['10.1016/j.jbtep.2020.101588'] 1799,32535481,Efficacy and safety of Abelmoschus manihot for IgA nephropathy: A multicenter randomized clinical trial.,"RATIONALE AND OBJECTIVE IgA nephropathy (IgAN) is an important cause for end-stage renal disease worldwide. The treatment for IgAN remains challenging, and few randomized and controlled clinical trials have been conducted to evaluate new therapies. The present study assesses the efficacy and safety of Abelmoschus manihot (AM) in IgAN patients. STUDY DESIGN Randomized, non-inferiority, double-blind, double-dummy multicenter trial. SETTING AND PARTICIPANTS This trial was designed to recruit 1,600 biopsy-proven IgAN patients (proteinuria between 0.5-3.0 g/d and estimated glomerular filtration rate [eGFR] of ≥ 45 ml/min/1.73 m 2 ) across China. INTERVENTIONS The participants were randomized at 1:1 to AM (2.5 g for three times per day) or losartan potassium (100 mg per day) for 48 weeks. OUTCOMES The primary outcome was the change in 24-hour proteinuria from baseline to week 48. The secondary outcomes were the change in eGFR from baseline to week 48, and the incidents of endpoint events (proteinuria ≥ 3.5 g/24 h, doubling of serum creatinine, or receiving renal replacement treatment). RESULTS Among 1,470 randomized patients (mean age, 37.4 [SD, 10.6] years old; 777 [52.9%] were female; mean eGFR, 95.0 [SD, 24.3] mL/min/1.73 m 2 ; mean 24-hour proteinuria, 1.2 [SD, 0.7] g/d), the mean decline in 24-h proteinuria at week 48 was 230 mg and 253 mg in the AM and losartan potassium groups, respectively (P = 0.676). The mean difference in the change in 24-h proteinuria between these two groups was -23.32 mg (95% confident interval: -123.2 to 76.6, p = 0.647). The mean decline in eGFR was 0.41 ml/min/1.73 m 2 and 0.76 ml/min/1.73 m 2 in the AM and losartan potassium groups, respectively (p = 0.661). The mean difference in the change in eGFR between these two groups was -0.43 ml/min/1.73 m 2 (95% confident interval: -1.99 to 1.13, p = 0.589). The incidence of endpoint events was 8.6% in the AM group and 8.2% in the losartan group (p = 0.851). LIMITATIONS The results of the trial may not be generalized to IgAN patients with a proteinuria of > 3.0 g/d and an eGFR of < 45 ml/min/1.73 m 2 . The long-term benefits of AM in reducing the risk of progressive renal dysfunction remains unclear, based on this 48-week observation. CONCLUSION AM can be recommended as a promising treatment for IgAN patients.",2020,The mean difference in the change in eGFR between these two groups was -0.43,"['IgAN patients', '1,470 randomized patients (mean age, 37.4 [SD, 10.6] years old; 777 [52.9%] were female; mean eGFR, 95.0 [SD, 24.3] mL/min/1.73 m 2 ; mean 24-hour proteinuria, 1.2 [SD, 0.7] g/d), the mean decline in 24-h proteinuria at week 48 was 230 mg and 253 mg in the AM and losartan potassium groups, respectively (P\xa0=\xa00.676', 'IgA nephropathy', '1,600 biopsy-proven IgAN patients (proteinuria between 0.5-3.0 g/d and estimated glomerular filtration rate [eGFR] of ≥ 45 ml/min/1.73 m 2 ) across China']","['AM', 'Abelmoschus manihot (AM', 'losartan potassium', 'Abelmoschus manihot', 'losartan']","['change in 24-hour proteinuria', 'eGFR', '24-h proteinuria', 'Efficacy and safety', 'mean decline in eGFR', 'incidence of endpoint events', 'efficacy and safety', 'change in eGFR']","[{'cui': 'C0017661', 'cui_str': 'IgA nephropathy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517741', 'cui_str': '37.4'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0033687', 'cui_str': 'Proteinuria'}, {'cui': 'C4068880', 'cui_str': '1.2'}, {'cui': 'C4517474', 'cui_str': '0.7'}, {'cui': 'C0439417', 'cui_str': 'g/24h'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0949866', 'cui_str': 'Abelmoschus'}, {'cui': 'C0996896', 'cui_str': 'Manihot'}, {'cui': 'C0700492', 'cui_str': 'Losartan potassium'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0456369', 'cui_str': 'Proven'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C0949866', 'cui_str': 'Abelmoschus'}, {'cui': 'C0996896', 'cui_str': 'Manihot'}, {'cui': 'C0700492', 'cui_str': 'Losartan potassium'}, {'cui': 'C0126174', 'cui_str': 'Losartan'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0033687', 'cui_str': 'Proteinuria'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0441471', 'cui_str': 'Event'}]",1470.0,0.162545,The mean difference in the change in eGFR between these two groups was -0.43,"[{'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Li', 'Affiliation': 'Department of Nephrology, Chinese PLA Institute of Nephrology, State Key Laboratory of Kidney Diseases, National Clinical Research Center for Kidney Diseases, Chinese PLA General Hospital, Chinese PLA Medical School, Beijing 100853, China.'}, {'ForeName': 'Hongli', 'Initials': 'H', 'LastName': 'Lin', 'Affiliation': 'Department of Nephrology, The First Affiliated Hospital of Dalian Medical University, Dalian, Liaoning 116011, China.'}, {'ForeName': 'Zhaohui', 'Initials': 'Z', 'LastName': 'Ni', 'Affiliation': 'Department of Nephrology, Renji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai 200127, China.'}, {'ForeName': 'Yongli', 'Initials': 'Y', 'LastName': 'Zhan', 'Affiliation': ""Department of Nephrology, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing 100053, China.""}, {'ForeName': 'Yani', 'Initials': 'Y', 'LastName': 'He', 'Affiliation': 'Department of Nephrology, Da Ping Hospital of Third Military Medical University, Chongqing, 400042, China.'}, {'ForeName': 'Hongtao', 'Initials': 'H', 'LastName': 'Yang', 'Affiliation': 'Department of Nephrology, First Teaching Hospital of Tianjin University of TCM, Tianjin 300192, China.'}, {'ForeName': 'Jingai', 'Initials': 'J', 'LastName': 'Fang', 'Affiliation': 'Department of Nephrology, The First Hospital of Shanxi Medical University, Taiyuan 030024, China.'}, {'ForeName': 'Niansong', 'Initials': 'N', 'LastName': 'Wang', 'Affiliation': 'Department of Nephrology, The Six Affiliated Hospital of Shanghai Jiao Tong University School of Medicine, Shanghai 200233, China.'}, {'ForeName': 'Wenge', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'Department of Nephrology, China-Japan Friendship Hospital, Beijing 100029, China.'}, {'ForeName': 'Guangyan', 'Initials': 'G', 'LastName': 'Cai', 'Affiliation': 'Department of Nephrology, Chinese PLA Institute of Nephrology, State Key Laboratory of Kidney Diseases, National Clinical Research Center for Kidney Diseases, Chinese PLA General Hospital, Chinese PLA Medical School, Beijing 100853, China.'}, {'ForeName': 'Yizhi', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Department of Nephrology, Chinese PLA Institute of Nephrology, State Key Laboratory of Kidney Diseases, National Clinical Research Center for Kidney Diseases, Chinese PLA General Hospital, Chinese PLA Medical School, Beijing 100853, China.'}, {'ForeName': 'Peiqing', 'Initials': 'P', 'LastName': 'Zhang', 'Affiliation': 'Department of Nephrology, Heilongjiang Provincial Academy of Traditional Chinese Medicine, Heilongjiang, 150036, China.'}, {'ForeName': 'Xiaoqin', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Department of Nephrology, Hubei Provincial Hospital of Traditional Chinese Medicine, Wuhan, 430061, China.'}, {'ForeName': 'Qinkai', 'Initials': 'Q', 'LastName': 'Chen', 'Affiliation': 'Department of Nephrology, The First Affiliated Hospital of Nanchang University, Nanchang, 330006, China.'}, {'ForeName': 'Zhenjiang', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': ""Department of Nephrology, Shanxi Provincial People's Hospital, Xi'an, 710068, China.""}, {'ForeName': 'Xuefeng', 'Initials': 'X', 'LastName': 'Sun', 'Affiliation': 'Department of Nephrology, Chinese PLA Institute of Nephrology, State Key Laboratory of Kidney Diseases, National Clinical Research Center for Kidney Diseases, Chinese PLA General Hospital, Chinese PLA Medical School, Beijing 100853, China. Electronic address: xfssun@126.com.'}, {'ForeName': 'Xiangmei', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Department of Nephrology, Chinese PLA Institute of Nephrology, State Key Laboratory of Kidney Diseases, National Clinical Research Center for Kidney Diseases, Chinese PLA General Hospital, Chinese PLA Medical School, Beijing 100853, China. Electronic address: xmchen301@126.com.'}]",Phytomedicine : international journal of phytotherapy and phytopharmacology,['10.1016/j.phymed.2020.153231'] 1800,32567372,Application of Zizao Yangrong Granules for Treating Targeted Drugs-Related Skin Xerosis: A Randomized Double-Blinded Controlled Study.,"Background: Dermatologic toxicities are the most common side effects associated with the targeted drugs epidermal growth factor receptor inhibitors (EGFRIs), in which xerosis commonly complicated by pruritus severely disturbs the quality of life. The study has observed the curative effect of Zizao Yangrong granules (ZYG) from Chishui Xuanzhu in the treatment of EGFRIs-related xerosis and pruritus, as well as evaluating the safety of the prescription. Methods: Patients (n = 68) who had xerosis after using EGFRIs were enrolled and then randomly divided into the treatment group and control group, respectively, receiving ZYG and placebo granules combined with vitamin E ointment. The intervention lasted 4 weeks. Changes in xerosis and pruritus were observed, and blood routine examination as well as liver and kidney function are observed as safety indexes . The water content of skin and qualify of life were observed . Results: A total of 66 out of 68 patients finished the study with 34 patients in each group . The effective rates of xerosis among the treatment group and control group were 84.8% and 69.7% after 2 weeks' treatment ( P < .05), while they were 84.8% and 75.8% after 4 weeks' treatment ( P < .05). The patients in the experimental group had better quality of life than that in the control group ( P = .045). Conclusion: ZYG can effectively improve the skin dryness associated with EGFRIs, and significantly improve the quality of life of patients with good safety; however, larger randomized controlled trials are needed to verify these findings.",2020,The patients in the experimental group had better quality of life than that in the control group ( P = .045). ,"['A total of 66 out of 68 patients finished the study with 34 patients in each group ', 'Methods: Patients (n = 68) who had xerosis after using EGFRIs', 'Skin Xerosis']","['ZYG and placebo granules combined with vitamin E ointment', 'Zizao Yangrong granules (ZYG) from Chishui Xuanzhu', 'Zizao Yangrong Granules']","['quality of life', 'effective rates of xerosis', 'blood routine examination', 'xerosis and pruritus', 'Dermatologic toxicities', 'skin dryness', 'water content of skin and qualify of life']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1706059', 'cui_str': 'Finish'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0259817', 'cui_str': 'Xerosis'}, {'cui': 'C0263465', 'cui_str': 'Asteatosis cutis'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0010837', 'cui_str': 'Cytoplasmic Granules'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0042874', 'cui_str': 'Vitamin E'}, {'cui': 'C0028912', 'cui_str': 'Ointment'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0259817', 'cui_str': 'Xerosis'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C0205489', 'cui_str': 'Dermatologic'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0151908', 'cui_str': 'Dry skin'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0376558', 'cui_str': 'Life'}]",68.0,0.0597227,The patients in the experimental group had better quality of life than that in the control group ( P = .045). ,"[{'ForeName': 'Yan Mei', 'Initials': 'YM', 'LastName': 'Peng', 'Affiliation': 'Fangshan Hospital, Beijing University of Chinese Medicine, Beijing, China.'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Duan', 'Affiliation': 'Beijing University of Chinese Medicine, Beijing, China.'}, {'ForeName': 'Jingyi', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Beijing University of Chinese Medicine, Beijing, China.'}, {'ForeName': 'Chenyao', 'Initials': 'C', 'LastName': 'Sun', 'Affiliation': 'Beijing University of Chinese Medicine, Beijing, China.'}, {'ForeName': 'Xu', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Beijing University of Chinese Medicine, Beijing, China.'}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Shen', 'Affiliation': 'Beijing University of Chinese Medicine, Beijing, China.'}, {'ForeName': 'Shuyue', 'Initials': 'S', 'LastName': 'Zheng', 'Affiliation': 'Beijing University of Chinese Medicine, Beijing, China.'}, {'ForeName': 'Kexin', 'Initials': 'K', 'LastName': 'Tan', 'Affiliation': 'Beijing University of Chinese Medicine, Beijing, China.'}, {'ForeName': 'Xuejiao', 'Initials': 'X', 'LastName': 'Jiang', 'Affiliation': 'Beijing University of Chinese Medicine, Beijing, China.'}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Beijing University of Chinese Medicine, Beijing, China.'}, {'ForeName': 'Hui Juan', 'Initials': 'HJ', 'LastName': 'Cui', 'Affiliation': 'China-Japan Friendship Hospital, Beijing, China.'}]",Integrative cancer therapies,['10.1177/1534735420924832'] 1801,32567433,Glycemic variability in type 2 diabetes mellitus and acute coronary syndrome: liraglutide compared with insulin glargine: a pilot study.,"OBJECTIVE To explore the glucagon-like peptide-1 analogue liraglutide in the hospital setting in patients with type 2 diabetes mellitus (T2DM) and acute coronary syndrome and to evaluate the safety and efficacy and its impact on hospitalization and short-term glycemic variability (GV). METHODS A 12-week, open-label, prospective, randomized pilot clinical study with parallel groups that compared liraglutide (group 1) with glargine (group 2) and its impact on glycemic control and GV. RESULTS Thirteen patients were included. During hospitalization, mean glucose was 164.75 mg/dL (standard deviation [SD] 19.94) in group 1 and 166.69 mg/dL (38.22) in group 2. GV determined by CV and SD was 20.98 (7.68) vs. 25.48 (7.19) and 34.37 (13.05) vs. 43.56 (19.53) in groups 1 and 2, respectively. Group 1 prandial insulin requirements during hospitalization were lower compared with group 2. Follow-up A1c in group 1 was 6.9% (-1.51%) and 6.5% in group 2 (-1.27). GV after discharge and hypoglycemia were lower in group 1 compared with group 2. CONCLUSIONS Liraglutide seems to reduce GV in the acute phase of acute coronary syndrome, and patients achieved optimal control with a low incidence of hypoglycemia. These results support the need to explore liraglutide in a larger multicenter trial. Trial registration: The study was approved by the National Medical Ethics Committee of Spain. The study was registered at European Clinical Trials Database (EudraCT): 2014003298-40.",2020,"GV after discharge and hypoglycemia were lower in group 1 compared with group 2. ","['patients with type 2 diabetes mellitus (T2DM) and acute coronary syndrome', 'Thirteen patients were included', 'type 2 diabetes mellitus and acute coronary syndrome']","['glargine', 'liraglutide', 'Liraglutide', 'glucagon-like peptide-1 analogue liraglutide', 'insulin glargine']","['GV determined by CV and SD', 'GV after discharge and hypoglycemia', 'Glycemic variability']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-like peptide 1'}]","[{'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}]",13.0,0.0629473,"GV after discharge and hypoglycemia were lower in group 1 compared with group 2. ","[{'ForeName': 'Maria Isabel', 'Initials': 'MI', 'LastName': 'Del Olmo-García', 'Affiliation': 'Hospital Universitario La Fe (Valencia), Valenciana, Spain.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Hervás Marín', 'Affiliation': 'Unidad Bioestadistica, Instituto de Investigación Sanitaria IIS La Fe (Valencia), Valenciana, Spain.'}, {'ForeName': 'Jana', 'Initials': 'J', 'LastName': 'Caudet Esteban', 'Affiliation': 'Hospital Universitario La Fe (Valencia), Valenciana, Spain.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Ballesteros Martin-Portugués', 'Affiliation': 'Hospital Universitario La Fe (Valencia), Valenciana, Spain.'}, {'ForeName': 'Alba', 'Initials': 'A', 'LastName': 'Cerveró Rubio', 'Affiliation': 'Hospital Universitario La Fe (Valencia), Valenciana, Spain.'}, {'ForeName': 'Miguel Angel', 'Initials': 'MA', 'LastName': 'Arnau Vives', 'Affiliation': 'Hospital Universitario La Fe (Valencia), Valenciana, Spain.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Catalá Gregori', 'Affiliation': 'Unidad Mixta Investigacion Endocrinología, Nutrición y Dietética, IIS La Fe, Valenciana, Spain.'}, {'ForeName': 'Maite', 'Initials': 'M', 'LastName': 'Penalba Martínez', 'Affiliation': 'Hospital Universitario La Fe (Valencia), Valenciana, Spain.'}, {'ForeName': 'Juan Francisco', 'Initials': 'JF', 'LastName': 'Merino-Torres', 'Affiliation': 'Hospital Universitario La Fe (Valencia), Valenciana, Spain.'}]",The Journal of international medical research,['10.1177/0300060520926063'] 1802,32567438,Brief cycles of lower-limb occlusion accelerate recovery kinetics in soccer players.,"OBJECTIVE The aim of this study was to assess the effect of intermittent vascular occlusion (IVO) on recovery following simulated soccer physical demand test in soccer players. METHODS Twelve soccer players completed the Loughborough Intermittent Shuttle Test (LIST) in two conditions placebo (PLA) and IVO followed by intermittent lower-limb occlusion. Physical performance (Squat jump: SJ, countermovement jump: CMJ, maximal voluntary contraction: MVC, and 20 m sprint: SP), muscle damage parameters (creatine kinase: CK, Lactate dehydrogenase: LDH), inflammatory parameter (C-reactive protein: CRP), and perceived muscle soreness (DOMS) were assessed before, immediately after (0 h), and 24 h, 48 h, and 72 h following the exercise. RESULTS Following the LIST, a decrease was observed in all Physical performance within 48 h in PLA condition (p < 0.05), compared to PLA treatment, IVO treatment attenuated the decrease of SJ and CMJ at 24 h and at 48 h and for MVC and SP within 48 h after the LIST (p < 0.05). CK and LDH levels increased within 24 h post-exercise in both conditions (p < 0.05), but with a lower level in IVO compared to PLA condition (p < 0.05). Likewise, DOMS values were significantly lower with IVO condition compared to PLA condition immediately and at 24 h after exercise. CONCLUSION The results of the present study suggest that the application of IVO after simulated soccer physical demand test accelerated recovery kinetics in soccer players.",2020,"CK and LDH levels increased within 24h post exercise in both conditions (p<0.05), but with a lower level in IVO compared to PLA condition (p<0.05).","['Twelve soccer players completed the', 'soccer players']","['Loughborough Intermittent Shuttle Test (LIST) in two conditions placebo (PLA) and IVO followed by intermittent lower limb occlusion', 'intermittent vascular occlusion (IVO']","['Likewise, DOMS values', 'SJ and CMJ', 'CK and LDH levels', 'Physical performance (Squat jump: SJ, countermovement jump: CMJ, maximal voluntary contraction: MVC, and 20 meters sprint: SP), muscle damage parameters (creatine kinase: CK, Lactate dehydrogenase: LDH), inflammatory parameter (C-reactive protein: CRP) and perceived muscle soreness (DOMS', 'Physical performance']","[{'cui': 'C0037393', 'cui_str': 'Soccer'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0430518', 'cui_str': 'Shuttle test'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1096458', 'cui_str': 'Vascular occlusion'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}]","[{'cui': 'C0013007', 'cui_str': 'Methyldimethoxyamphetamine'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0022917', 'cui_str': 'Lactate dehydrogenase'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0241236', 'cui_str': 'Does squat'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}, {'cui': 'C0441074', 'cui_str': 'Meters'}, {'cui': 'C0410158', 'cui_str': 'Muscle damage NOS'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0010287', 'cui_str': 'Creatine kinase'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0231528', 'cui_str': 'Muscle pain'}]",,0.0603503,"CK and LDH levels increased within 24h post exercise in both conditions (p<0.05), but with a lower level in IVO compared to PLA condition (p<0.05).","[{'ForeName': 'Wael', 'Initials': 'W', 'LastName': 'Daab', 'Affiliation': 'UR15JS01: Education, Motricité, Sport Et Santé (EM2S), High Institute of Sport and Physical Education, University of Sfax , Sfax, Tunisia.'}, {'ForeName': 'Mohamed Amine', 'Initials': 'MA', 'LastName': 'Bouzid', 'Affiliation': 'UR15JS01: Education, Motricité, Sport Et Santé (EM2S), High Institute of Sport and Physical Education, University of Sfax , Sfax, Tunisia.'}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Lajri', 'Affiliation': 'UR15JS01: Education, Motricité, Sport Et Santé (EM2S), High Institute of Sport and Physical Education, University of Sfax , Sfax, Tunisia.'}, {'ForeName': 'Mustapha', 'Initials': 'M', 'LastName': 'Bouchiba', 'Affiliation': 'UR15JS01: Education, Motricité, Sport Et Santé (EM2S), High Institute of Sport and Physical Education, University of Sfax , Sfax, Tunisia.'}, {'ForeName': 'Haithem', 'Initials': 'H', 'LastName': 'Rebai', 'Affiliation': 'UR15JS01: Education, Motricité, Sport Et Santé (EM2S), High Institute of Sport and Physical Education, University of Sfax , Sfax, Tunisia.'}]",The Physician and sportsmedicine,['10.1080/00913847.2020.1785260'] 1803,32563939,Association of Meteorin-Like Hormone with insulin resistance and body composition in healthy Iranian adults.,"BACKGROUND AND AIMS Sedentary behavior and/or physical inactivity are modifiable risk factors for noncommunicable diseases. Myokines are one of the mediators of physical activity health benefits. Relationship between regular physical activity (RPA) and baseline plasma Meteorin-Like Hormone (Metrnl) has not been explored in human. Hence, we compared baseline plasma Metrnl between sedentary individuals and ones with recreational physical activities, and role of Metrnl as a biological messenger between physical activity and insulin resistance and body composition was also explored. METHODS Forty healthy young men (aged: 21 ± 2.1 yrs; BMI: 23 ± 3.44 kg/m 2 ) completed the study. Participants were equally assigned into two groups of control (sedentary) and case (recreational athletes). Baseline plasma Metrnl, glucose, insulin and body composition components and insulin resistance index (HOMA-IR) were assessed under resting conditions. RESULTS Except for baseline blood glucose, baseline plasma Metrnl, insulin, HOMA-IR and body mass index and body fat percentage were similar between two groups (P > 0.05). However, after Metrnl correction for the degree of insulin resistance index (Metrnl/HOMA-IR), recreational athletes showed a significantly greater baseline compared to sedentary subjects (P < 0.05). Baseline blood glucose showed a negative and significant correlation with baseline plasma Metrnl (P < 0.05). CONCLUSIONS Baseline plasma Metrnl is correlated with regular physical activity and insulin sensitivity, but not with body composition parameters. Metrnl may be one possible mediator of the beneficial effects of PA on insulin sensitivity in healthy humans. Hence, increasing awareness of the benefits of physical activity and incorporating physical activity into lifestyle are of great importance for people with non-communicable diseases.",2020,"Baseline plasma Metrnl, glucose, insulin and body composition components and insulin resistance index (HOMA-IR) were assessed under resting conditions. ","['healthy humans', 'Forty healthy young men (aged: 21\xa0±\xa02.1\xa0yrs', 'people with non-communicable diseases', 'healthy Iranian adults']","['Meteorin-Like Hormone with insulin resistance and body composition', 'regular physical activity (RPA) and baseline plasma Meteorin-Like Hormone (Metrnl']","['Baseline blood glucose', 'degree of insulin resistance index (Metrnl/HOMA-IR', 'baseline plasma Metrnl', 'baseline blood glucose, baseline plasma Metrnl, insulin, HOMA-IR and body mass index and body fat percentage', 'Baseline plasma Metrnl, glucose, insulin and body composition components and insulin resistance index (HOMA-IR']","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4068876', 'cui_str': '2.1'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C4505065', 'cui_str': 'Non-infectious Diseases'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0449432', 'cui_str': 'Component'}]",40.0,0.0269477,"Baseline plasma Metrnl, glucose, insulin and body composition components and insulin resistance index (HOMA-IR) were assessed under resting conditions. ","[{'ForeName': 'Hamid', 'Initials': 'H', 'LastName': 'Alizadeh', 'Affiliation': 'Faculty of Sport Sciences, University of Mazandaran, Babolsar, Mazandaran, Iran. Electronic address: h.alizadeh.aw@gmail.com.'}, {'ForeName': 'Aliakbar', 'Initials': 'A', 'LastName': 'Alizadeh', 'Affiliation': 'Faculty of Sports Sciences, University of Shahid Chamran of Ahvaz, Iran. Electronic address: aliakbar.alizadeh1984@gmail.com.'}]",Diabetes & metabolic syndrome,['10.1016/j.dsx.2020.05.031'] 1804,32563960,Cost-effectiveness of preoperative magnetic resonance imaging to optimize surgery in ductal carcinoma in situ of the breast.,"PURPOSE Complete surgical excision is the main factor for successful breast-conserving surgery in patients with ductal carcinoma in situ (DCIS) of the breast. Preoperative magnetic resonance imaging (MRI) may allow surgery optimization in this indication. From an economic standpoint, systematic preoperative MRI is associated with an extra cost, which may be offset by a decrease in the number of re-interventions. We performed an economic evaluation alongside IRCIS randomised controlled trial (NCT01112254) to determine whether systematic preoperative MRI in DCIS is a cost-effective strategy. METHODS 360 patients were included in IRCIS trial. Costs were assessed from the French national health insurance perspective. Resource use was prospectively collected during a 6-month period after randomisation. We estimated the mean cost per averted re-intervention. RESULTS Despite extra costs due to MRI and additional biopsies, difference in total costs between arms was not statistically significant (mean cost of €9980 in MRI arm and €9682 in no MRI arm, cost difference: €298 [CI95% : -470; 1063]). There was a non-significant decrease in the rate of re-hospitalisations for positive or close margins (20% in MRI arm versus 27% in No MRI arm, difference -7% [CI95% : -17; 3]). At a willingness to pay of €500 to avert a re-intervention, the probability that MRI strategy is cost-effective was 93%. CONCLUSION Systematic preoperative MRI in patients with DCIS of the breast may be a cost-effective strategy. However, the modest clinical benefit associated with such a strategy limits the interest for this procedure in routine practice given the current MRI techniques.",2020,"Despite extra costs due to MRI and additional biopsies, difference in total costs between arms was not statistically significant (mean cost of €9980 in MRI arm and €9682 in no MRI arm, cost difference:","['360 patients were included in IRCIS trial', '€298', 'ductal carcinoma in situ of the breast', 'patients with ductal carcinoma in situ (DCIS) of the breast']","['Preoperative magnetic resonance imaging (MRI', 'preoperative magnetic resonance imaging']","['total costs', 'mean cost per averted re-intervention', 'rate of re-hospitalisations']","[{'cui': 'C4319607', 'cui_str': '360'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0007124', 'cui_str': 'Intraductal carcinoma, noninfiltrating'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}]",360.0,0.132549,"Despite extra costs due to MRI and additional biopsies, difference in total costs between arms was not statistically significant (mean cost of €9980 in MRI arm and €9682 in no MRI arm, cost difference:","[{'ForeName': 'Marguerite', 'Initials': 'M', 'LastName': 'Kandel', 'Affiliation': ""Gustave Roussy, Service de Biostatistique et d'Epidémiologie, Villejuif, F-94805, France; CESP, Fac. de médecine, Univ. Paris-Sud, Fac. de médecine, UVSQ, INSERM, Université Paris-Saclay, Villejuif, 94805, France.""}, {'ForeName': 'Ariane', 'Initials': 'A', 'LastName': 'Dunant', 'Affiliation': ""Gustave Roussy, Service de Biostatistique et d'Epidémiologie, Villejuif, F-94805, France.""}, {'ForeName': 'Corinne', 'Initials': 'C', 'LastName': 'Balleyguier', 'Affiliation': 'Gustave Roussy, Department of Medical Imaging, 114 rue Edouard Vaillant, Villejuif, F-94805, France. Electronic address: corinne.balleyguier@gustaveroussy.fr.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Bonastre', 'Affiliation': ""Gustave Roussy, Service de Biostatistique et d'Epidémiologie, Villejuif, F-94805, France; CESP, Fac. de médecine, Univ. Paris-Sud, Fac. de médecine, UVSQ, INSERM, Université Paris-Saclay, Villejuif, 94805, France.""}]",European journal of radiology,['10.1016/j.ejrad.2020.109058'] 1805,32565123,An acute bout of swimming increases post-exercise energy intake in young healthy men and women.,"Single bouts of land-based exercise (for example, walking, running, cycling) do not typically alter post-exercise energy intake on the day of exercise. However, anecdotal and preliminary empirical evidence suggests that swimming may increase appetite and energy intake. This study compared the acute effects of swimming on appetite, energy intake, and food preference and reward, versus exertion-matched cycling and a resting control. Thirty-two men (n = 17; mean ± SD age 24 ± 2 years, body mass index [BMI] 25.0 ± 2.6 kg/m 2 ) and women (n = 15; age 22 ± 3 years, BMI 22.8 ± 2.3 kg/m 2 ) completed three experimental trials (swimming, cycling, control) in a randomised, crossover design. The exercise trials involved 60-min of 'hard' exercise (self-selected rating of perceived exertion: 15) performed 90-min after a standardised breakfast. Food preference and reward were assessed via the Leeds Food Preference Questionnaire 15-min after exercise, whilst ad libitum energy intake was determined 30-min after exercise. The control trial involved identical procedures except no exercise was performed. Compared with control (3259 ± 1265 kJ), swimming increased ad libitum energy intake (3857 ± 1611 kJ; ES = 0.47, 95% CI of the mean difference between trials 185, 1010 kJ, P = 0.005); the magnitude of increase was smaller after cycling (3652 ± 1619 kJ; ES = 0.31, 95% CI -21, 805 kJ, P = 0.062). Ad libitum energy intake was similar between swimming and cycling (ES = 0.16, 95% CI -207, 618 kJ, P = 0.324). This effect was consistent across sexes and unrelated to food preference and reward which were similar after swimming and cycling compared with control. This study has identified an orexigenic effect of swimming. Further research is needed to identify the responsible mechanism(s), including the relevance of water immersion and water temperature per se.",2020,This effect was consistent across sexes and unrelated to food preference and reward which were similar after swimming and cycling compared with control.,"['young healthy men and women', 'Thirty-two men (n\u202f=\u202f17; mean\u202f±\u202fSD age 24\u202f±\u202f2 years, body mass index [BMI] 25.0\u202f±\u202f2.6\u202fkg/m 2 ) and women (n\u202f=\u202f15', 'age 22\u202f±\u202f3 years, BMI 22.8\u202f±\u202f2.3\u202fkg/m 2 ']","[""60-min of 'hard' exercise (self-selected rating of perceived exertion: 15) performed 90-min after a standardised breakfast"", 'Single bouts of land-based exercise']","['appetite, energy intake, and food preference and reward, versus exertion-matched cycling', 'Ad libitum energy intake', 'appetite and energy intake']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0450357', 'cui_str': '32'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517633', 'cui_str': '2.6'}]","[{'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0018599', 'cui_str': 'Hard'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C2698559', 'cui_str': 'Breakfast time'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0557668', 'cui_str': 'Landing'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C0016483', 'cui_str': 'Food Preferences'}, {'cui': 'C0035397', 'cui_str': 'Rewards'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0336766', 'cui_str': 'Matches'}]",,0.135485,This effect was consistent across sexes and unrelated to food preference and reward which were similar after swimming and cycling compared with control.,"[{'ForeName': 'Alice E', 'Initials': 'AE', 'LastName': 'Thackray', 'Affiliation': 'National Centre for Sport and Exercise Medicine, School of Sport Exercise and Health Sciences, Loughborough University, UK; National Institute for Health Research (NIHR) Leicester Biomedical Research Centre, University Hospitals of Leicester NHS Trust and University of Leicester, Leicester, UK. Electronic address: A.E.Thackray@lboro.ac.uk.'}, {'ForeName': 'Scott A', 'Initials': 'SA', 'LastName': 'Willis', 'Affiliation': 'National Centre for Sport and Exercise Medicine, School of Sport Exercise and Health Sciences, Loughborough University, UK; National Institute for Health Research (NIHR) Leicester Biomedical Research Centre, University Hospitals of Leicester NHS Trust and University of Leicester, Leicester, UK. Electronic address: S.Willis2@lboro.ac.uk.'}, {'ForeName': 'Aron P', 'Initials': 'AP', 'LastName': 'Sherry', 'Affiliation': 'National Centre for Sport and Exercise Medicine, School of Sport Exercise and Health Sciences, Loughborough University, UK; National Institute for Health Research (NIHR) Leicester Biomedical Research Centre, University Hospitals of Leicester NHS Trust and University of Leicester, Leicester, UK. Electronic address: A.P.Sherry@lboro.ac.uk.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Clayton', 'Affiliation': 'School of Science and Technology, Nottingham Trent University, UK. Electronic address: David.Clayton@ntu.ac.uk.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Broom', 'Affiliation': 'Centre for Sport, Exercise and Life Sciences, Coventry University, UK. Electronic address: ad5173@coventry.ac.uk.'}, {'ForeName': 'Mayada', 'Initials': 'M', 'LastName': 'Demashkieh', 'Affiliation': 'Department of Physical Education and Sport Science, Nanyang Technological University, Singapore. Electronic address: Mayada.Demashkieh@nie.edu.sg.'}, {'ForeName': 'Jack A', 'Initials': 'JA', 'LastName': 'Sargeant', 'Affiliation': 'National Institute for Health Research (NIHR) Leicester Biomedical Research Centre, University Hospitals of Leicester NHS Trust and University of Leicester, Leicester, UK; Diabetes Research Centre, University of Leicester, UK. Electronic address: js928@leicester.ac.uk.'}, {'ForeName': 'Lewis J', 'Initials': 'LJ', 'LastName': 'James', 'Affiliation': 'National Centre for Sport and Exercise Medicine, School of Sport Exercise and Health Sciences, Loughborough University, UK. Electronic address: L.James@lboro.ac.uk.'}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'Finlayson', 'Affiliation': 'Faculty of Medicine and Health, University of Leeds, UK. Electronic address: G.S.Finlayson@leeds.ac.uk.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Stensel', 'Affiliation': 'National Centre for Sport and Exercise Medicine, School of Sport Exercise and Health Sciences, Loughborough University, UK; National Institute for Health Research (NIHR) Leicester Biomedical Research Centre, University Hospitals of Leicester NHS Trust and University of Leicester, Leicester, UK. Electronic address: D.J.Stensel@lboro.ac.uk.'}, {'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'King', 'Affiliation': 'National Centre for Sport and Exercise Medicine, School of Sport Exercise and Health Sciences, Loughborough University, UK; National Institute for Health Research (NIHR) Leicester Biomedical Research Centre, University Hospitals of Leicester NHS Trust and University of Leicester, Leicester, UK. Electronic address: j.a.king@lboro.ac.uk.'}]",Appetite,['10.1016/j.appet.2020.104785'] 1806,32528654,Learning to make informed health choices: Protocol for a pilot study in schools in Barcelona.,"Introduction: The Informed Health Choices (IHC) project has developed learning resources to teach primary school children (10 to 12-year-olds) to assess treatment claims and make informed health choices. The aim of our study is to explore both the students' and teachers' experience when using these resources in the context of Barcelona (Spain). Methods: During the 2019-2020 school year, we will conduct a pilot study with 4 th and 5 th -year primary school students (9 to 11-year-olds) from three schools in Barcelona. The intervention in the schools will include: 1) a workshop with the teachers, and 2) lessons to the students. The data collection will include: 1) assessment of the IHC resources by the teachers before the lessons, 2) non-participatory observations during the lessons, 3) semi-structured interviews with the students after a lesson, 4) assessment of the lessons by the teachers after a lesson, 5) treatment claim assessment by the students at the end of the lessons, and 6) assessment of the IHC resources by the teachers at the end of the lessons. We will use ad hoc questionnaires and guides to register the data. We will perform a quantitative and qualitative analysis of the data to explore understandability, desirability, suitability, usefulness, facilitators and barriers of the resources. The most relevant results will be discussed and some recommendations on how to use, how to adapt (if needed), and how to implement the IHC resources to this context will be agreed. The findings of the contextualization activities could inform the design of a cluster-randomised trial, to determine the effectiveness of the IHC resources in this context prior to scaling-up its use. Ethical considerations: The study protocol has obtained an approval exemption from the Ethics Committee of the Hospital de la Santa Creu i Sant Pau (Barcelona, Spain).",2019,"The findings of the contextualization activities could inform the design of a cluster-randomised trial, to determine the effectiveness of the IHC resources in this context prior to scaling-up its use. ","['schools in Barcelona', 'primary school children (10 to 12-year-olds', 'During the 2019-2020 school year, we will conduct a pilot study with 4 th and 5 th -year primary school students (9 to 11-year-olds) from three schools in Barcelona']","['IHC resources by the teachers before the lessons, 2) non-participatory observations during the lessons, 3) semi-structured interviews with the students after a lesson, 4) assessment of the lessons by the teachers after a lesson, 5) treatment claim assessment', 'Santa Creu']",[],"[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0033145', 'cui_str': 'Primary school'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0031928', 'cui_str': 'Pilot Study'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0038492', 'cui_str': 'Student'}]","[{'cui': 'C0021044', 'cui_str': 'Immunohistochemistry'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",[],,0.0303023,"The findings of the contextualization activities could inform the design of a cluster-randomised trial, to determine the effectiveness of the IHC resources in this context prior to scaling-up its use. ","[{'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Martínez García', 'Affiliation': 'Iberoamerican Cochrane Centre (IbCC) - Sant Pau Biomedical Research Institute (IIB-Sant Pau), Barcelona, Spain.'}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Alonso-Coello', 'Affiliation': 'Iberoamerican Cochrane Centre (IbCC) - Sant Pau Biomedical Research Institute (IIB-Sant Pau), Barcelona, Spain.'}, {'ForeName': 'Laia', 'Initials': 'L', 'LastName': 'Asso Ministral', 'Affiliation': 'Maternal and Child Health Service, General Subdirectorate of Health Promotion, Public Health Agency of Catalonia, Barcelona, Spain.'}, {'ForeName': 'Clara', 'Initials': 'C', 'LastName': 'Ballesté-Delpierre', 'Affiliation': 'ISGlobal, Hospital Clínic, University of Barcelona, Barcelona, Spain.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Canelo Aybar', 'Affiliation': 'Iberoamerican Cochrane Centre (IbCC) - Sant Pau Biomedical Research Institute (IIB-Sant Pau), Barcelona, Spain.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'de Britos', 'Affiliation': 'Escola Virolai, Barcelona, Spain.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Fernández Rodríguez', 'Affiliation': 'Escola Sant Martí, Barcelona, Spain.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Gallego Iborra', 'Affiliation': 'Andalusian Health Service, Malaga, Spain.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Leo Rosas', 'Affiliation': 'Iberoamerican Cochrane Centre (IbCC) - Sant Pau Biomedical Research Institute (IIB-Sant Pau), Barcelona, Spain.'}, {'ForeName': 'Paloma', 'Initials': 'P', 'LastName': 'Llaquet', 'Affiliation': 'Escola Virolai, Barcelona, Spain.'}, {'ForeName': 'Ena Pery', 'Initials': 'EP', 'LastName': 'Niño de Guzmán Quispe', 'Affiliation': 'Iberoamerican Cochrane Centre (IbCC) - Sant Pau Biomedical Research Institute (IIB-Sant Pau), Barcelona, Spain.'}, {'ForeName': 'Giordano', 'Initials': 'G', 'LastName': 'Pérez-Gaxiola', 'Affiliation': 'Paediatric Hospital of Sinaloa, Sinaloa, Mexico.'}, {'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'Requeijo', 'Affiliation': 'Epidemiology and Public Health Department, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain.'}, {'ForeName': 'Karla', 'Initials': 'K', 'LastName': 'Salas-Gama', 'Affiliation': 'Epidemiology and Public Health Department, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Samsó Jofra', 'Affiliation': 'Epidemiology and Public Health Department, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain.'}, {'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Terres', 'Affiliation': 'Institut Escola Antaviana, Barcelona, Spain.'}, {'ForeName': 'Iratxe', 'Initials': 'I', 'LastName': 'Urreta', 'Affiliation': 'Clinical Epidemiology and Research Unit, University Hospital of Donostia, Donostia, Spain.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Rosenbaum', 'Affiliation': 'Centre for Informed Health Choices, Norwegian Institute of Public Health, Oslo, Norway.'}]",F1000Research,['10.12688/f1000research.21292.3'] 1807,31491384,Antibiotics-Driven Gut Microbiome Perturbation Alters Immunity to Vaccines in Humans.,"Emerging evidence indicates a central role for the microbiome in immunity. However, causal evidence in humans is sparse. Here, we administered broad-spectrum antibiotics to healthy adults prior and subsequent to seasonal influenza vaccination. Despite a 10,000-fold reduction in gut bacterial load and long-lasting diminution in bacterial diversity, antibody responses were not significantly affected. However, in a second trial of subjects with low pre-existing antibody titers, there was significant impairment in H1N1-specific neutralization and binding IgG1 and IgA responses. In addition, in both studies antibiotics treatment resulted in (1) enhanced inflammatory signatures (including AP-1/NR4A expression), observed previously in the elderly, and increased dendritic cell activation; (2) divergent metabolic trajectories, with a 1,000-fold reduction in serum secondary bile acids, which was highly correlated with AP-1/NR4A signaling and inflammasome activation. Multi-omics integration revealed significant associations between bacterial species and metabolic phenotypes, highlighting a key role for the microbiome in modulating human immunity.",2019,"However, in a second trial of subjects with low pre-existing antibody titers, there was significant impairment in H1N1-specific neutralization and binding IgG1 and IgA responses.","['healthy adults prior and subsequent to seasonal influenza vaccination', 'Humans']",['Antibiotics-Driven Gut Microbiome Perturbation'],"['dendritic cell activation; (2) divergent metabolic trajectories', 'H1N1-specific neutralization and binding IgG1 and IgA responses', 'gut bacterial load and long-lasting diminution in bacterial diversity, antibody responses']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0439601', 'cui_str': 'Seasonal course'}, {'cui': 'C0042200', 'cui_str': 'Influenza vaccination'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}]","[{'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C0332453', 'cui_str': 'Disruption'}]","[{'cui': 'C0003315', 'cui_str': 'Immunologic Accessory Cells'}, {'cui': 'C0580264', 'cui_str': 'H1N1'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0332297', 'cui_str': 'Bounded by'}, {'cui': 'C0020855', 'cui_str': 'Immunoglobulin IgG1'}, {'cui': 'C0020835', 'cui_str': 'Immunoglobulin A'}, {'cui': 'C0017189', 'cui_str': 'Gastrointestinal tract structure'}, {'cui': 'C2936404', 'cui_str': 'Bacterial Load'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0332511', 'cui_str': 'Decreased size'}, {'cui': 'C0003261', 'cui_str': 'Antibody Production'}]",2.0,0.024709,"However, in a second trial of subjects with low pre-existing antibody titers, there was significant impairment in H1N1-specific neutralization and binding IgG1 and IgA responses.","[{'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Hagan', 'Affiliation': 'Institute for Immunity, Transplantation and Infection, School of Medicine, Stanford University, Stanford, CA 94305, USA.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Cortese', 'Affiliation': 'Institute for Immunity, Transplantation and Infection, School of Medicine, Stanford University, Stanford, CA 94305, USA.'}, {'ForeName': 'Nadine', 'Initials': 'N', 'LastName': 'Rouphael', 'Affiliation': 'Hope Clinic of the Emory Vaccine Center, Decatur, GA 30030, USA.'}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Boudreau', 'Affiliation': 'Ragon Institute of MGH, MIT and Harvard, Cambridge, MA 02139, USA.'}, {'ForeName': 'Caitlin', 'Initials': 'C', 'LastName': 'Linde', 'Affiliation': 'Ragon Institute of MGH, MIT and Harvard, Cambridge, MA 02139, USA.'}, {'ForeName': 'Mohan S', 'Initials': 'MS', 'LastName': 'Maddur', 'Affiliation': 'Emory Vaccine Center, Yerkes National Primate Research Center, Atlanta, GA 30329, USA.'}, {'ForeName': 'Jishnu', 'Initials': 'J', 'LastName': 'Das', 'Affiliation': 'Ragon Institute of MGH, MIT and Harvard, Cambridge, MA 02139, USA.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Emory Vaccine Center, Yerkes National Primate Research Center, Atlanta, GA 30329, USA.'}, {'ForeName': 'Jenna', 'Initials': 'J', 'LastName': 'Guthmiller', 'Affiliation': 'Department of Medicine, Section of Rheumatology, Knapp Center for Lupus and Immunology, University of Chicago, Chicago, IL 60637, USA.'}, {'ForeName': 'Nai-Ying', 'Initials': 'NY', 'LastName': 'Zheng', 'Affiliation': 'Department of Medicine, Section of Rheumatology, Knapp Center for Lupus and Immunology, University of Chicago, Chicago, IL 60637, USA.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Huang', 'Affiliation': 'Department of Medicine, Section of Rheumatology, Knapp Center for Lupus and Immunology, University of Chicago, Chicago, IL 60637, USA.'}, {'ForeName': 'Amit A', 'Initials': 'AA', 'LastName': 'Uphadhyay', 'Affiliation': 'Emory Vaccine Center, Yerkes National Primate Research Center, Atlanta, GA 30329, USA.'}, {'ForeName': 'Luiz', 'Initials': 'L', 'LastName': 'Gardinassi', 'Affiliation': 'Department of Medicine, Emory University, Atlanta, GA 30303, USA.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Petitdemange', 'Affiliation': 'Emory Vaccine Center, Yerkes National Primate Research Center, Atlanta, GA 30329, USA.'}, {'ForeName': 'Michele Paine', 'Initials': 'MP', 'LastName': 'McCullough', 'Affiliation': 'Hope Clinic of the Emory Vaccine Center, Decatur, GA 30030, USA.'}, {'ForeName': 'Sara Jo', 'Initials': 'SJ', 'LastName': 'Johnson', 'Affiliation': 'Hope Clinic of the Emory Vaccine Center, Decatur, GA 30030, USA.'}, {'ForeName': 'Kiran', 'Initials': 'K', 'LastName': 'Gill', 'Affiliation': 'Emory Vaccine Center, Yerkes National Primate Research Center, Atlanta, GA 30329, USA.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Cervasi', 'Affiliation': 'Emory Vaccine Center, Yerkes National Primate Research Center, Atlanta, GA 30329, USA.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Zou', 'Affiliation': 'Center for Inflammation, Immunity, and Infection, Institute for Biomedical Sciences, Georgia State University, Atlanta, GA 30303, USA.'}, {'ForeName': 'Alexis', 'Initials': 'A', 'LastName': 'Bretin', 'Affiliation': 'Center for Inflammation, Immunity, and Infection, Institute for Biomedical Sciences, Georgia State University, Atlanta, GA 30303, USA.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Hahn', 'Affiliation': 'Division of Viral Products, Center for Biologics Evaluation and Research, Food and Drug Administration, Silver Spring, MD 20993, USA.'}, {'ForeName': 'Andrew T', 'Initials': 'AT', 'LastName': 'Gewirtz', 'Affiliation': 'Center for Inflammation, Immunity, and Infection, Institute for Biomedical Sciences, Georgia State University, Atlanta, GA 30303, USA.'}, {'ForeName': 'Steve E', 'Initials': 'SE', 'LastName': 'Bosinger', 'Affiliation': 'Emory Vaccine Center, Yerkes National Primate Research Center, Atlanta, GA 30329, USA.'}, {'ForeName': 'Patrick C', 'Initials': 'PC', 'LastName': 'Wilson', 'Affiliation': 'Department of Medicine, Section of Rheumatology, Knapp Center for Lupus and Immunology, University of Chicago, Chicago, IL 60637, USA.'}, {'ForeName': 'Shuzhao', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'Department of Medicine, Emory University, Atlanta, GA 30303, USA.'}, {'ForeName': 'Galit', 'Initials': 'G', 'LastName': 'Alter', 'Affiliation': 'Ragon Institute of MGH, MIT and Harvard, Cambridge, MA 02139, USA.'}, {'ForeName': 'Surender', 'Initials': 'S', 'LastName': 'Khurana', 'Affiliation': 'Division of Viral Products, Center for Biologics Evaluation and Research, Food and Drug Administration, Silver Spring, MD 20993, USA.'}, {'ForeName': 'Hana', 'Initials': 'H', 'LastName': 'Golding', 'Affiliation': 'Division of Viral Products, Center for Biologics Evaluation and Research, Food and Drug Administration, Silver Spring, MD 20993, USA.'}, {'ForeName': 'Bali', 'Initials': 'B', 'LastName': 'Pulendran', 'Affiliation': 'Institute for Immunity, Transplantation and Infection, School of Medicine, Stanford University, Stanford, CA 94305, USA; Department of Pathology, Stanford University School of Medicine, Stanford University, Stanford, CA 94305, USA; Department of Microbiology & Immunology, Stanford University School of Medicine, Stanford University, Stanford, CA 94305, USA. Electronic address: bpulend@stanford.edu.'}]",Cell,['10.1016/j.cell.2019.08.010'] 1808,32546431,Tezacaftor/ivacaftor in people with cystic fibrosis heterozygous for minimal function CFTR mutations.,"BACKGROUND Tezacaftor/ivacaftor is a CFTR modulator approved to treat people with cystic fibrosis (pwCF) who are homozygous (F/F) or heterozygous for the F508del-CFTR mutation and a residual function mutation (F/RF). This randomized, double-blind, placebo-controlled Phase 3 study evaluated the efficacy, safety, tolerability, and pharmacokinetics (PK) of tezacaftor/ivacaftor in participants ≥12 years of age heterozygous for the F508del-CFTR mutation and a minimal function mutation (F/MF), which produces no CFTR protein or a protein unresponsive to tezacaftor/ivacaftor in vitro. METHODS Participants were randomized 1:1 to receive tezacaftor/ivacaftor or placebo for 12 weeks. The primary endpoint was the absolute change from baseline in percent predicted forced expiratory volume in 1 second (ppFEV 1 ) between the tezacaftor/ivacaftor and placebo groups through week 12. Key secondary endpoints included absolute change from baseline in CF Questionnaire-Revised respiratory domain scores and the number of pulmonary exacerbations through week 12 and the absolute change from baseline in body mass index at week 12. A prespecified interim analysis (IA) for futility was conducted when approximately 50% of a planned enrollment of 300 participants reached week 12 of the study. RESULTS At the time of the IA, 83 participants were randomized to tezacaftor/ivacaftor and 85 to placebo; 165 participants completed treatment. The study failed to demonstrate that tezacaftor/ivacaftor significantly improved ppFEV 1 or any of the key secondary endpoints and was terminated for futility. The safety profile and PK parameters of tezacaftor/ivacaftor were similar to those reported in prior studies in participants ≥12 years of age with CF. CONCLUSIONS Tezacaftor/ivacaftor did not show a clinically meaningful benefit in participants with F/MF genotypes but was generally safe and well tolerated, consistent with the safety profile reported in other Phase 3 studies (NCT02516410).",2020,The study failed to demonstrate that tezacaftor/ivacaftor significantly improved ppFEV 1 or any of the key secondary endpoints and was terminated for futility.,"['165 participants completed treatment', 'participants ≥12 years of age with CF', 'people with cystic fibrosis ', 'Participants', '83 participants', '300 participants reached week 12 of the study', 'participants ≥12 years of age heterozygous for the F508del-CFTR mutation and a minimal function mutation (F/MF), which produces no CFTR protein or a protein unresponsive to tezacaftor/ivacaftor in vitro', 'people with cystic fibrosis heterozygous for minimal function CFTR mutations']","['pwCF', 'tezacaftor/ivacaftor or placebo', 'tezacaftor/ivacaftor', 'Tezacaftor/ivacaftor', 'placebo']","['efficacy, safety, tolerability, and pharmacokinetics (PK', 'safety profile and PK parameters of tezacaftor/ivacaftor', 'absolute change from baseline in CF Questionnaire-Revised respiratory domain scores and the number of pulmonary exacerbations', 'absolute change from baseline in percent predicted forced expiratory volume in 1\xa0second (ppFEV 1 ', 'safe and well tolerated']","[{'cui': 'C4319555', 'cui_str': '165'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0010674', 'cui_str': 'Cystic fibrosis'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0019425', 'cui_str': 'Heterozygote'}, {'cui': 'C0056889', 'cui_str': 'CFTR Protein'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0038164', 'cui_str': 'Protein A'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C4519194', 'cui_str': 'tezacaftor'}, {'cui': 'C3264621', 'cui_str': 'ivacaftor'}, {'cui': 'C0021135', 'cui_str': 'In Vitro'}]","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0010674', 'cui_str': 'Cystic fibrosis'}, {'cui': 'C4519194', 'cui_str': 'tezacaftor'}, {'cui': 'C3264621', 'cui_str': 'ivacaftor'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C4519194', 'cui_str': 'tezacaftor'}, {'cui': 'C3264621', 'cui_str': 'ivacaftor'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0730561', 'cui_str': 'Percent predicted FEV1'}]",83.0,0.465593,The study failed to demonstrate that tezacaftor/ivacaftor significantly improved ppFEV 1 or any of the key secondary endpoints and was terminated for futility.,"[{'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Munck', 'Affiliation': 'Robert Debré Hospital, Assistance Publique-Hopitaux de Paris, Université Paris Diderot, Paris, France. Electronic address: anne.munck1@gmail.com.'}, {'ForeName': 'Eitan', 'Initials': 'E', 'LastName': 'Kerem', 'Affiliation': 'Department of Pediatrics and Cystic Fibrosis Center, Hadassah-Hebrew University Medical Center, Mount Scopus, Jerusalem, Israel. Electronic address: eitank@hadassah.org.il.'}, {'ForeName': 'Helmut', 'Initials': 'H', 'LastName': 'Ellemunter', 'Affiliation': 'Department of Child and Adolescent Health, Division of Cardiology, Pulmonology, Allergology, and Cystic Fibrosis, Cystic Fibrosis Centre, Medical University of Innsbruck, Innsbruck, Austria. Electronic address: helmut.ellemunter@i-med.ac.at.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Campbell', 'Affiliation': 'Vertex Pharmaceuticals Incorporated, Boston, MA, USA. Electronic address: Daniel_Campbell@vrtx.com.'}, {'ForeName': 'Linda T', 'Initials': 'LT', 'LastName': 'Wang', 'Affiliation': 'Vertex Pharmaceuticals Incorporated, Boston, MA, USA. Electronic address: Linda_Wang@vrtx.com.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Ahluwalia', 'Affiliation': 'Vertex Pharmaceuticals Incorporated, Boston, MA, USA. Electronic address: Neil_Ahluwalia@vrtx.com.'}, {'ForeName': 'Caroline A', 'Initials': 'CA', 'LastName': 'Owen', 'Affiliation': 'Vertex Pharmaceuticals Incorporated, Boston, MA, USA. Electronic address: Caroline_Owen@vrtx.com.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Wainwright', 'Affiliation': 'Faculty of Medicine, University of Queensland, South Brisbane, Queensland, Australia. Electronic address: claire.wainwright@health.qld.gov.au.'}]",Journal of cystic fibrosis : official journal of the European Cystic Fibrosis Society,['10.1016/j.jcf.2020.04.015'] 1809,32546421,Small changes in glucose variability induced by low and high glycemic index diets are not associated with changes in β-cell function in adults with pre-diabetes.,"Oscillating glucose levels can increase oxidative stress and may contribute to β-cell dysfunction. We tested the hypothesis that increased glycemic variability contributes to β-cell dysfunction by experimentally altering glucose variability with controlled diets varying in glycemic index (GI). Fifty-two adults with prediabetes received a 2-week moderate GI (GI = 55-58) control diet followed by randomization to a four-week low GI (LGI: GI < 35) or high GI (HGI HI > 70) diet. Those on the HGI diet were randomized to placebo or the antioxidant N-acetylcysteine (NAC). Participants underwent blinded CGMS, fasting oxidative stress markers and an intravenous glucose tolerance test to estimate β-cell function (disposition index: DI). On the control diet, DI was inversely correlated with SD glucose (r = -0.314, p = 0.03), but neither DI nor glucose variability were associated with oxidative stress markers. The LGI diet decreased SD glucose (Control 0.96 ± 0.08 vs. LGI 0.79 ± 0.06, p = 0.02) while the HGI diet increased it (Control 0.88 ± 0.06 vs. HGI 1.06 ± 0.07, p = 0.03). Neither DI nor oxidative stress markers changed after the LGI or HGI diets. NAC had no effect on DI, glucose variability or oxidative stress markers. We conclude small changes in glucose variability induced by dietary GI in adults with pre-diabetes are unlikely to contribute to β-cell dysfunction.",2020,"The LGI diet decreased SD glucose (Control 0.96 ± 0.08 vs. LGI 0.79 ± 0.06, p = 0.02) while the HGI diet increased it (Control 0.88 ± 0.06 vs. HGI 1.06 ± 0.07, p = 0.03).","['Fifty-two adults with prediabetes received a', 'adults with pre-diabetes']","['2-week moderate GI (GI\u202f=\u202f55-58) control diet followed by randomization to a four-week low GI (LGI: GI\u202f<\u202f35) or high GI (HGI HI', 'antioxidant N-acetylcysteine (NAC', 'NAC', 'placebo']","['oxidative stress markers', 'oxidative stress', 'SD glucose', 'glucose variability', 'β-cell function', 'DI, glucose variability or oxidative stress markers']","[{'cui': 'C4319570', 'cui_str': '52'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0271650', 'cui_str': 'Impaired glucose tolerance'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}]","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C1136206', 'cui_str': 'Glycemic Index Number'}, {'cui': 'C0743195', 'cui_str': 'Dietary control'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0001047', 'cui_str': 'Acetylcysteine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0007613', 'cui_str': 'Physiology, Cell'}]",52.0,0.0150612,"The LGI diet decreased SD glucose (Control 0.96 ± 0.08 vs. LGI 0.79 ± 0.06, p = 0.02) while the HGI diet increased it (Control 0.88 ± 0.06 vs. HGI 1.06 ± 0.07, p = 0.03).","[{'ForeName': 'Kristina M', 'Initials': 'KM', 'LastName': 'Utzschneider', 'Affiliation': 'Research and Development, Department of Medicine, 1660 S Columbian Way (151), VA Puget Sound Health Care System, Seattle, WA 98108, USA; Division of Metabolism, Endocrinology and Nutrition, University of Washington, 1959 NE Pacific Street, Seattle, WA 98195-6426, USA. Electronic address: kutzschn@uw.edu.'}, {'ForeName': 'Tonya N', 'Initials': 'TN', 'LastName': 'Johnson', 'Affiliation': 'Research and Development, Department of Medicine, 1660 S Columbian Way (151), VA Puget Sound Health Care System, Seattle, WA 98108, USA; Seattle Institute for BIomedical and Clinical Research, Seattle, WA, USA.'}, {'ForeName': 'Kara L', 'Initials': 'KL', 'LastName': 'Breymeyer', 'Affiliation': 'Public Health Sciences Division, Fred Hutchinson Cancer Research Center, 1100 Fairview Ave N, Seattle, WA 98109, USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Bettcher', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, University of Washington, 1959 NE Pacific Street, Seattle, WA 98195-6426, USA. Electronic address: bettcher@uw.edu.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Raftery', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, University of Washington, 1959 NE Pacific Street, Seattle, WA 98195-6426, USA. Electronic address: draftery@uw.edu.'}, {'ForeName': 'Katherine M', 'Initials': 'KM', 'LastName': 'Newton', 'Affiliation': 'Kaiser Permanente Health Research Institute, 1730 Minor Ave, Seattle, WA 98101, USA. Electronic address: Katherine.M.Newton@kp.org.'}, {'ForeName': 'Marian L', 'Initials': 'ML', 'LastName': 'Neuhouser', 'Affiliation': 'Public Health Sciences Division, Fred Hutchinson Cancer Research Center, 1100 Fairview Ave N, Seattle, WA 98109, USA. Electronic address: mneuhous@fredhutch.org.'}]",Journal of diabetes and its complications,['10.1016/j.jdiacomp.2020.107586'] 1810,32544297,Long-term safety and efficacy of N8-GP in previously treated adults and adolescents with hemophilia A: Final results from pathfinder2.,"BACKGROUND N8-GP (turoctocog alfa pegol; Esperoct ® , Novo Nordisk A/S, Bagsvaerd, Denmark) is a glycoPEGylated human recombinant factor VIII with a half-life of ~1.6-fold of standard FVIII products. pathfinder2 (NCT01480180) was a multi-national, open-label trial of N8-GP in previously treated adolescent and adult patients with severe hemophilia A. OBJECTIVE We report end-of-trial efficacy and safety of N8-GP from pathfinder2. METHODS pathfinder2 main phase and extension phase part 1 results have been previously reported. During extension phase part 2, patients could switch from N8-GP prophylaxis 50 IU/kg every fourth day (Q4D) or 75 IU/kg once-weekly (Q7D), depending on bleeding status. Extension phase part 2 collected long-term safety and efficacy data for all regimens until trial end (first patient in main phase, 30 Jan 2012; trial end, 10 Dec 2018). RESULTS Overall, 186 patients were exposed to N8-GP for up to 6.6 years (median 5.4 years). The estimated annualized bleeding rate (ABR) was 2.14 (median 0.84) for the Q4D prophylaxis arm and 1.31 (median 1.67) for the Q7D prophylaxis arm. Nearly 30% of patients experienced 0 bleeds throughout the entire duration of the trial, the hemostatic response was 83.2% across all treatment arms, and patient-reported outcomes were maintained or slightly improved. No safety concerns were detected. CONCLUSION Data from the completed pathfinder2 trial, one of the largest and longest-running clinical trials to investigate treatment of severe hemophilia A, demonstrate the efficacy and safety of N8-GP in previously treated adolescent and adult patients.",2020,The estimated annualized bleeding rate (ABR) was 2.14 (median 0.84) for the Q4D prophylaxis arm and 1.31 (median 1.67) for the Q7D prophylaxis arm.,"['previously treated adults and adolescents with hemophilia A', 'previously treated adolescent and adult patients', '186 patients were exposed to N8-GP for up to 6.6\xa0years (median 5.4\xa0years', 'previously treated adolescent and adult patients with severe hemophilia A']",['N8-GP'],"['hemostatic response', 'annualized bleeding rate (ABR']","[{'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0019069', 'cui_str': 'Hereditary factor VIII deficiency disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C4517823', 'cui_str': '6.6'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C4517792', 'cui_str': '5.4'}, {'cui': 'C0272322', 'cui_str': 'Severe hereditary factor VIII deficiency disease'}]",[],"[{'cui': 'C0019116', 'cui_str': 'Hemostatic function'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}]",186.0,0.0938106,The estimated annualized bleeding rate (ABR) was 2.14 (median 0.84) for the Q4D prophylaxis arm and 1.31 (median 1.67) for the Q7D prophylaxis arm.,"[{'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Giangrande', 'Affiliation': 'Department of Clinical and Laboratory Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Faraizah', 'Initials': 'F', 'LastName': 'Abdul Karim', 'Affiliation': 'National Blood Centre, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Laszlo', 'Initials': 'L', 'LastName': 'Nemes', 'Affiliation': 'National Hemophilia Center, Hemostasis Department, Medical Center, Hungarian Defence Forces, Budapest, Hungary.'}, {'ForeName': 'Chur Woo', 'Initials': 'CW', 'LastName': 'You', 'Affiliation': 'Pediatric Department, Eulji University Hospital, Daejeon, Republic of Korea.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Landorph', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Milan S', 'Initials': 'MS', 'LastName': 'Geybels', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Curry', 'Affiliation': 'Oxford Haemophilia and Thrombosis Centre and Oxford National Institute for Health Research Biomedical Research Centre, Churchill Hospital, Oxford, UK.'}]",Journal of thrombosis and haemostasis : JTH,['10.1111/jth.14959'] 1811,32544846,"A fructose-based meal challenge to assess metabotypes and their metabolic risk profile: A randomized, crossover, controlled trial.","OBJECTIVES The first aim of this study was to determine the metabolic type of individuals based on the postprandial metabolic response after the ingestion of a meal challenge that was high protein and either high glucose (high GI) or fructose (low GI). The second aim was to compare the baseline characteristics between the different metabolic types (metabotypes). The third aim was to assess whether the inclusion of fructose or glucose in a high-protein breakfast modulated the glucose, insulin, and TG response over a 4-h period. METHODS The study included 46 Asian women with a body mass index between 17 and 28 kg/m 2 in a randomized crossover design. Metabolic typing was based on the assessment of the postprandial glycemic, insulin and triacylglycerol (TG) response after the ingestion of two high-protein meal challenges either high in fructose or glucose. Baseline characteristics were compared between the different metabolic types. Baseline and 4-h postprandial blood samples were collected and glucose, insulin, and TG levels were analyzed. Cluster analysis was used to phenotype the participants in distinct groups. Baseline characteristics including anthropometry, glycemic, and lipid profiles and resting metabolic rate were compared among the metabolic types. RESULTS Cluster analysis revealed that women could be grouped into three metabolic types based on postprandial glucose, insulin, and TG response after the fructose meal challenge: cluster 1 with an average glucose + high TG response (highTG; n = 12), cluster 2 with a high glucose + average TG response (highGLU; n = 8), and cluster 3 with an average glucose + average TG response (Avg; n = 26). Post hoc analysis revealed significantly greater waist-to-hip ratio and a worse lipid profile for the highTG cluster and a higher fasting blood glucose, body mass index, fat percentage, and hip circumference in the highGLU cluster. CONCLUSIONS Three metabolic types with a distinct metabolic response could be distinguished after a high fructose meal. The results suggest a different risk profile and may indicate why some people develop diabetes in an obesogenic environment. Improved metabolic-type assessments will enable us to develop and optimize nutritional and medical interventions for individuals with differing diabetes risk.",2020,"Post hoc analysis revealed significantly greater waist-to-hip ratio and a worse lipid profile for the highTG cluster and a higher fasting blood glucose, body mass index, fat percentage, and hip circumference in the highGLU cluster. ","['46 Asian women with a body mass index between 17 and 28 kg/m 2', 'individuals with differing diabetes risk']","['high glucose (high GI) or fructose (low GI', 'fructose-based meal challenge']","['waist-to-hip ratio', 'fasting blood glucose, body mass index, fat percentage, and hip circumference', 'glucose, insulin, and TG levels', 'glucose, insulin, and TG response', 'postprandial glycemic, insulin and triacylglycerol (TG) response', 'Baseline and 4-h postprandial blood samples', 'postprandial glucose, insulin, and TG response', 'anthropometry, glycemic, and lipid profiles and resting metabolic rate', 'postprandial metabolic response']","[{'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]","[{'cui': 'C0860803', 'cui_str': 'Glucose increased'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0016745', 'cui_str': 'Fructose'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1998602', 'cui_str': 'Meals'}]","[{'cui': 'C0205682', 'cui_str': 'Waist/hip ratio'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0562350', 'cui_str': 'Hip circumference'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0003188', 'cui_str': 'Anthropometry'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C4082350', 'cui_str': 'Resting Metabolic Rate'}]",46.0,0.0341195,"Post hoc analysis revealed significantly greater waist-to-hip ratio and a worse lipid profile for the highTG cluster and a higher fasting blood glucose, body mass index, fat percentage, and hip circumference in the highGLU cluster. ","[{'ForeName': 'Stefan Gerardus', 'Initials': 'SG', 'LastName': 'Camps', 'Affiliation': 'Singapore Institute of Food and Biotechnology Innovation, Agency for Science, Technology and Research and National University Health System, Singapore.'}, {'ForeName': 'Huann Rong', 'Initials': 'HR', 'LastName': 'Koh', 'Affiliation': 'Singapore Institute of Food and Biotechnology Innovation, Agency for Science, Technology and Research and National University Health System, Singapore.'}, {'ForeName': 'Nan Xin', 'Initials': 'NX', 'LastName': 'Wang', 'Affiliation': 'Singapore Institute of Food and Biotechnology Innovation, Agency for Science, Technology and Research and National University Health System, Singapore.'}, {'ForeName': 'Christiani Jeyakumar', 'Initials': 'CJ', 'LastName': 'Henry', 'Affiliation': 'Singapore Institute of Food and Biotechnology Innovation, Agency for Science, Technology and Research and National University Health System, Singapore; Department of Biochemistry, Yong Loo Lin School of Medicine, National University of Singapore, Singapore. Electronic address: jeya_henry@sifbi.a-star.edu.sg.'}]","Nutrition (Burbank, Los Angeles County, Calif.)",['10.1016/j.nut.2020.110799'] 1812,32544854,Effect of ZNF804A gene polymorphism (rs1344706) on the plasticity of the functional coupling between the right dorsolateral prefrontal cortex and the contralateral hippocampal formation.,"ZNF804A has now been recognized as a schizophrenia risk gene by multiple genome-wide association studies with its intronic polymorphism rs1344706 being reported as the first genome-wide significant risk variant for schizophrenia. Although the functional impact of this gene is still unknown, rs1344706's contribution to the functional coupling between the right dorsolateral prefrontal cortex (DLPFC) and the contralateral hippocampal formation (HF) has been reported by several studies. The current study tested whether the right DLPFC-left HF functional coupling showed plasticity during cognitive training (Study I) and whether rs1344706 affected the plasticity (Study II). In Study I, we conducted a randomized controlled trial with 30 subjects receiving 20 sessions of adaptive training on a memory span task (the training group) and 30 subjects practicing on a non-adaptive easy version of the same memory span task for 20 sessions (the control group). All subjects were scanned using fMRI before and after the training. Analyses of resting-state and task-state fMRI data consistently showed that the adaptive memory span training significantly strengthened the right DLPFC-left HF functional coupling. In Study II, we conducted a genetic association study with 101 subjects (combining the data from the training group in Study I with those from an additional subsequent sample of 71 subjects who received the same training and fMRI scans). Results showed that rs1344706 was significantly associated with training-induced changes in functional coupling. Subjects carrying the non-risk allele (C) of rs1344706 showed greater training-induced plasticity than the risk allele (A) homozygotes. These findings expanded our current understanding of the functional impact of the schizophrenia risk variant of ZNF804A gene and suggested that the ZNF804A gene could be used as a prospective target for future antipsychotic drugs and clinical research.",2020,Subjects carrying the non-risk allele (C) of rs1344706 showed greater training-induced plasticity than the risk allele (A) homozygotes.,"['101 subjects (combining the data from the training group in Study', '71 subjects who received the same training and fMRI scans', '30 subjects receiving 20 sessions of adaptive training on a memory span task (the training group) and 30 subjects practicing on a non-adaptive easy version of the same memory span task for 20 sessions (the control group']","['ZNF804A', 'ZNF804A gene polymorphism (rs1344706']",['functional coupling'],"[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0332219', 'cui_str': 'Easy'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C0032529', 'cui_str': 'Genetic polymorphism'}]","[{'cui': 'C0205245', 'cui_str': 'Functional'}]",101.0,0.0118036,Subjects carrying the non-risk allele (C) of rs1344706 showed greater training-induced plasticity than the risk allele (A) homozygotes.,"[{'ForeName': 'Wan', 'Initials': 'W', 'LastName': 'Zhao', 'Affiliation': 'State Key Laboratory of Cognitive Neuroscience and Learning & IDG/McGovern Institute for Brain Research, Beijing Normal University, PR China.'}, {'ForeName': 'Xiongying', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'The National Clinical Research Center for Mental Disorders & Beijing Key Laboratory of Mental Disorders & Beijing Institute for Brain Disorders Center of Schizophrenia, Beijing Anding Hospital, Capital Medical University, Beijing 100088, PR China.'}, {'ForeName': 'Qiumei', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': 'State Key Laboratory of Cognitive Neuroscience and Learning & IDG/McGovern Institute for Brain Research, Beijing Normal University, PR China; School of Mental Health, Jining Medical University, 45# Jianshe South Road, Jining 272013, Shandong Province, PR China.'}, {'ForeName': 'Boqi', 'Initials': 'B', 'LastName': 'Du', 'Affiliation': 'State Key Laboratory of Cognitive Neuroscience and Learning & IDG/McGovern Institute for Brain Research, Beijing Normal University, PR China.'}, {'ForeName': 'Xiaoxiang', 'Initials': 'X', 'LastName': 'Deng', 'Affiliation': 'State Key Laboratory of Cognitive Neuroscience and Learning & IDG/McGovern Institute for Brain Research, Beijing Normal University, PR China.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Ji', 'Affiliation': 'School of Mental Health, Jining Medical University, 45# Jianshe South Road, Jining 272013, Shandong Province, PR China.'}, {'ForeName': 'Yu-Tao', 'Initials': 'YT', 'LastName': 'Xiang', 'Affiliation': 'Faculty of Health Sciences, University of Macau, Avenida da Universidade, Taipa, Macau, PR China.'}, {'ForeName': 'Chuanyue', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'The National Clinical Research Center for Mental Disorders & Beijing Key Laboratory of Mental Disorders & Beijing Institute for Brain Disorders Center of Schizophrenia, Beijing Anding Hospital, Capital Medical University, Beijing 100088, PR China.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Dong', 'Affiliation': 'State Key Laboratory of Cognitive Neuroscience and Learning & IDG/McGovern Institute for Brain Research, Beijing Normal University, PR China.'}, {'ForeName': 'Chuansheng', 'Initials': 'C', 'LastName': 'Chen', 'Affiliation': 'Department of Psychological Science, University of California, Irvine, CA 92697, United States.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'State Key Laboratory of Cognitive Neuroscience and Learning & IDG/McGovern Institute for Brain Research, Beijing Normal University, PR China. Electronic address: lijundp@bnu.edu.cn.'}]",NeuroImage. Clinical,['10.1016/j.nicl.2020.102279'] 1813,32545223,Impact of Molar Furcations on Photodynamic Therapy Outcomes: A 6-Month Split-Mouth Randomized Clinical Trial.,"The effectiveness of adjunctive photodynamic treatment (PDT) to non-surgical periodontal therapy has been shown to depend on initial periodontal status. As molar furcation involvement impairs healing response to non-surgical periodontal therapy, the aim of this study was to evaluate the impact of furcation involvement on PDT outcomes. Thirty-six patients suffering from severe chronic periodontitis were included in a 6-month split-mouth randomized clinical trial. PDT applications used the toluidine blue O and a light-emitting diode (LED) with a red spectrum. Repeated PDT applications were performed in addition to non-surgical periodontal treatment at baseline and at 3-months. Pocket probing depth (PPD), plaque index, bleeding on probing, and clinical attachment level were recorded at baseline, and again at 3- and 6-months. Furcation sites of molars were compared to other sites of molars and non-molars. Multilevel analysis showed no PDT effect in molar furcation sites while an additional significant reduction (odds ratio = 0.67) of pockets with PPD > 5 mm in other sites at 3-months was measured. PPD reduction appeared delayed in molar furcation sites treated with PDT. There is no additional apparent benefit to use PDT in molar furcation sites for the reduction of pockets with PPD > 5 mm contrary to other sites.",2020,There is no additional apparent benefit to use PDT in molar furcation sites for the reduction of pockets with PPD > 5 mm contrary to other sites.,['Thirty-six patients suffering from severe chronic periodontitis'],"['Molar Furcations', 'adjunctive photodynamic treatment (PDT']","['healing response', 'Photodynamic Therapy Outcomes', 'PPD reduction', 'Pocket probing depth (PPD), plaque index, bleeding on probing, and clinical attachment level', 'PDT effect in molar furcation sites']","[{'cui': 'C4319606', 'cui_str': '36'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0266929', 'cui_str': 'Chronic periodontitis'}]","[{'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0031740', 'cui_str': 'Photochemotherapy'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0011390', 'cui_str': 'Dental Plaque Indices'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}, {'cui': 'C0205145', 'cui_str': 'Site'}]",36.0,0.0345002,There is no additional apparent benefit to use PDT in molar furcation sites for the reduction of pockets with PPD > 5 mm contrary to other sites.,"[{'ForeName': 'Aymeric', 'Initials': 'A', 'LastName': 'Courval', 'Affiliation': 'Department of Periodontology, Dental Faculty, University of Strasbourg, 67000 Strasbourg, France.'}, {'ForeName': 'Laetitia', 'Initials': 'L', 'LastName': 'Harmouche', 'Affiliation': 'Department of Periodontology, Dental Faculty, University of Strasbourg, 67000 Strasbourg, France.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Mathieu', 'Affiliation': 'Department of Periodontology, Dental Faculty, University of Strasbourg, 67000 Strasbourg, France.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Petit', 'Affiliation': 'Department of Periodontology, Dental Faculty, University of Strasbourg, 67000 Strasbourg, France.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Huck', 'Affiliation': 'Department of Periodontology, Dental Faculty, University of Strasbourg, 67000 Strasbourg, France.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Séverac', 'Affiliation': 'Methodology and Biostatistics Group, Public Health Department, University Hospitals of Strasbourg, 67000 Strasbourg, France.'}, {'ForeName': 'Jean-Luc', 'Initials': 'JL', 'LastName': 'Davideau', 'Affiliation': 'Department of Periodontology, Dental Faculty, University of Strasbourg, 67000 Strasbourg, France.'}]",International journal of environmental research and public health,['10.3390/ijerph17114162'] 1814,32557338,Chronic adverse effects after an axillary lymphadenectomy in breast cancer patients after administering weaker and stronger postoperative analgesia: results of a prospective double-blind randomized study.,"PURPOSE The aim of this study was to compare the rate of chronic adverse effects after a weaker and stronger postoperative analgesia. METHODS A prospective double-blind randomized study included 117 breast cancer patients receiving tramadol for pain relief for 4 weeks after an axillary lymphadenectomy from 2015 to 2018. Patients with a larger dose received 75/650 mg of tramadol with paracetamol every 8 h and a group with a lower dose received 37.5/325 mg of tramadol with paracetamol every 8 h from the 2nd to the 29th postoperative day. 1 year after surgery, patients were evaluated for the presence of neuropathic pain, chronic pain, arm symptoms and lymphedema. RESULTS There was a trend for a lower rate of neuropathic pain after stronger analgesia in comparison to weaker analgesia (p = 0.059). Chronic pain was present in 18% of patients 1 year after the lymphadenectomy. There was no difference in the rate of chronic pain after stronger and weaker postoperative analgesia. Patients had less arm symptoms after a stronger analgesia than after a weaker analgesia (p = 0.02). Furthermore, there was a trend for a lower rate of lymphedema of the forearm after a stronger analgesia than after a lower analgesia (p = 0.078). CONCLUSIONS The patients who received a stronger postoperative analgesia had less arm symptoms and a better quality of life in comparison to patients who received a weaker analgesia. The patients who received a stronger postoperative analgesia had a statistical trend for less neuropathic pain in comparison to patients who received a weaker analgesia.",2020,There was a trend for a lower rate of neuropathic pain after stronger analgesia in comparison to weaker analgesia (p = 0.059).,"['for pain relief for 4\xa0weeks after an axillary lymphadenectomy from 2015 to 2018', 'breast cancer patients after administering weaker and stronger postoperative analgesia', '117 breast cancer patients receiving']","['tramadol with paracetamol', 'tramadol', 'axillary lymphadenectomy']","['rate of chronic adverse effects', 'quality of life', 'Chronic adverse effects', 'Chronic pain', 'rate of chronic pain', 'neuropathic pain, chronic pain, arm symptoms and lymphedema', 'postoperative analgesia', 'neuropathic pain']","[{'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0193867', 'cui_str': 'Excision of axillary lymph nodes'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C1762617', 'cui_str': 'Weak'}, {'cui': 'C0442821', 'cui_str': 'Strong'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}]","[{'cui': 'C0040610', 'cui_str': 'Tramadol'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0193867', 'cui_str': 'Excision of axillary lymph nodes'}]","[{'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0027796', 'cui_str': 'Neuralgia'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0024236', 'cui_str': 'Lymphedema'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}]",117.0,0.401534,There was a trend for a lower rate of neuropathic pain after stronger analgesia in comparison to weaker analgesia (p = 0.059).,"[{'ForeName': 'Nikola', 'Initials': 'N', 'LastName': 'Besic', 'Affiliation': 'Department of Surgical Oncology, Institute of Oncology, Zaloska 2, 1000, Ljubljana, Slovenia. nbesic@onko-i.si.'}, {'ForeName': 'Jaka', 'Initials': 'J', 'LastName': 'Smrekar', 'Affiliation': 'Faculty of Mathematics and Physics, University of Ljubljana, 1000, Ljubljana, Slovenia.'}, {'ForeName': 'Branka', 'Initials': 'B', 'LastName': 'Strazisar', 'Affiliation': 'Department of Anesthesiology, Institute of Oncology, Zaloska 2, 1000, Ljubljana, Slovenia.'}]",Breast cancer research and treatment,['10.1007/s10549-020-05713-3'] 1815,32558951,Anterior cruciate ligament reconstruction reinitiates an inflammatory and chondrodegenerative process in the knee joint.,"Anterior cruciate ligament (ACL) injury leads to a sustained increase in synovial fluid concentrations of inflammatory cytokines and biomarkers of cartilage breakdown. While this has been documented post-injury, it remains unclear whether ACL reconstruction surgery contributes to the inflammatory process and/or cartilage breakdown. This study is a secondary analysis of 14 patients (nine males/five females, mean age = 9, mean BMI = 28) enrolled in an IRB-approved randomized clinical trial. Arthrocentesis was performed at initial presentation (mean = 6 days post-injury), immediately prior to surgery (mean = 23 days post-injury), 1-week post-surgery, and 1-month post-surgery. Enzyme-linked immunosorbant assay kits were used to determine concentrations of carboxy-terminal telopeptides of type II collagen (CTXII), interleukin-6 (IL-6), and IL-1β in the synovial fluid. The log-transformed IL-1β was not normally distributed; therefore, changes between time points were evaluated using a non-parametric Kruskal-Wallis one-way ANOVA. IL-1β concentrations significantly increased from the day of surgery to the first postoperative time point (P ≤ .001) and significantly decreased at the 4-week postoperative visit (P = .03). IL-1β concentrations at the 4-week postoperative visit remained significantly greater than both preoperative time points (P > .05). IL-6 concentrations at 1-week post-surgery were significantly higher than at initial presentation (P = .013), the day of surgery (P < .001), and 4 weeks after surgery (P = .002). CTX-II concentrations did not differ between the first three-time points (P > .99) but significantly increased at 4 weeks post-surgery (P < .01). ACL reconstruction appears to reinitiate an inflammatory response followed by an increase in markers for cartilage degradation. ACL reconstruction appears to initiate a second ""inflammatory hit"" resulting in increased chondral breakdown suggesting that post-operative chondroprotection may be needed.",2020,CTX-II concentrations did not differ between the first three time points (p>.99) but significantly increased at 4 weeks post-surgery (p<.01).,"['14 patients (9 males/5 females, mean age=19, mean BMI=28) enrolled in an IRB-approved randomized clinical trial']","['Anterior Cruciate Ligament Reconstruction Reinitiates', 'ACL reconstruction']","['concentrations of CTXII, IL-6 and IL-1β', 'IL-1β concentrations', 'CTX-II concentrations']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0086911', 'cui_str': 'Ethics Committee, Research'}, {'cui': 'C0205540', 'cui_str': 'Approved'}, {'cui': 'C0206034', 'cui_str': 'Trials, Randomized Clinical'}]","[{'cui': 'C3178820', 'cui_str': 'Anterior Cruciate Ligament Reconstruction'}]","[{'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0010377', 'cui_str': 'Crotoxin'}]",,0.0209689,CTX-II concentrations did not differ between the first three time points (p>.99) but significantly increased at 4 weeks post-surgery (p<.01).,"[{'ForeName': 'Emily R', 'Initials': 'ER', 'LastName': 'Hunt', 'Affiliation': 'Department of Orthopedic Surgery and Sports Medicine, University of Kentucky, Lexington, Kentucky.'}, {'ForeName': 'Cale A', 'Initials': 'CA', 'LastName': 'Jacobs', 'Affiliation': 'Department of Orthopedic Surgery and Sports Medicine, University of Kentucky, Lexington, Kentucky.'}, {'ForeName': 'Caitlin E-W', 'Initials': 'CE', 'LastName': 'Conley', 'Affiliation': 'Department of Orthopedic Surgery and Sports Medicine, University of Kentucky, Lexington, Kentucky.'}, {'ForeName': 'Mary L', 'Initials': 'ML', 'LastName': 'Ireland', 'Affiliation': 'Department of Orthopedic Surgery and Sports Medicine, University of Kentucky, Lexington, Kentucky.'}, {'ForeName': 'Darren L', 'Initials': 'DL', 'LastName': 'Johnson', 'Affiliation': 'Department of Orthopedic Surgery and Sports Medicine, University of Kentucky, Lexington, Kentucky.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Lattermann', 'Affiliation': ""Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.""}]",Journal of orthopaedic research : official publication of the Orthopaedic Research Society,['10.1002/jor.24783'] 1816,32553489,"High Prevalence of Multidrug-Resistant Organism Colonization in 28 Nursing Homes: An ""Iceberg Effect"".","OBJECTIVE Determine the prevalence of methicillin-resistant Staphylococcus aureus (MRSA), vancomycin-resistant Enterococcus spp. (VRE), extended-spectrum beta-lactamase producing organisms (ESBLs), and carbapenem-resistant Enterobacteriaceae (CRE) among residents and in the environment of nursing homes (NHs). DESIGN Point prevalence sampling of residents and environmental sampling of high-touch objects in resident rooms and common areas. SETTING Twenty-eight NHs in Southern California from 2016 to 2017. PARTICIPANTS NH participants in Project PROTECT, a cluster-randomized trial of enhanced bathing and decolonization vs routine care. METHODS Fifty residents were randomly sampled per NH. Twenty objects were sampled, including 5 common room objects plus 5 objects in each of 3 rooms (ambulatory, total care, and dementia care residents). RESULTS A total of 2797 swabs were obtained from 1400 residents in 28 NHs. Median prevalence of multidrug-resistant organism (MDRO) carriage per NH was 50% (range: 24%-70%). Median prevalence of specific MDROs were as follows: MRSA, 36% (range: 20%-54%); ESBL, 16% (range: 2%-34%); VRE, 5% (range: 0%-30%); and CRE, 0% (range: 0%-8%). A median of 45% of residents (range: 24%-67%) harbored an MDRO without a known MDRO history. Environmental MDRO contamination was found in 74% of resident rooms and 93% of common areas. CONCLUSIONS AND IMPLICATIONS In more than half of the NHs, more than 50% of residents were colonized with MDROs of clinical and public health significance, most commonly MRSA and ESBL. Additionally, the vast majority of resident rooms and common areas were MDRO contaminated. The unknown submerged portion of the iceberg of MDRO carriers in NHs may warrant changes to infection prevention and control practices, particularly high-fidelity adoption of universal strategies such as hand hygiene, environmental cleaning, and decolonization.",2020,Median prevalence of multidrug-resistant organism (MDRO) carriage per NH was 50% (range: 24%-70%).,"['residents and environmental sampling of high-touch objects in resident rooms and common areas', '28 Nursing Homes', 'A total of 2797 swabs were obtained from 1400 residents in 28 NHs', 'NH participants', 'Fifty residents were randomly sampled per NH', 'Twenty-eight NHs in Southern California from 2016 to\xa02017', 'Twenty objects were sampled, including 5 common room objects plus 5 objects in each of 3 rooms (ambulatory, total care, and dementia care residents']","['vancomycin-resistant Enterococcus spp', 'enhanced bathing and decolonization vs routine care', 'VRE), extended-spectrum beta-lactamase producing organisms (ESBLs), and carbapenem-resistant Enterobacteriaceae (CRE']","['Environmental MDRO contamination', 'Median prevalence of specific MDROs', 'Median prevalence of multidrug-resistant organism (MDRO) carriage per NH']","[{'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0152054', 'cui_str': 'Touch'}, {'cui': 'C0347997', 'cui_str': 'Physical object'}, {'cui': 'C0205214', 'cui_str': 'Common'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0028688', 'cui_str': 'Long term care facility'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0183753', 'cui_str': 'Swab'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}]","[{'cui': 'C1265175', 'cui_str': 'Vancomycin resistant enterococcus'}, {'cui': 'C0074992', 'cui_str': 'sphingosine 1-phosphate'}, {'cui': 'C0518460', 'cui_str': 'Bathing'}, {'cui': 'C4520447', 'cui_str': 'Decolonization'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0486433', 'cui_str': 'Extended-spectrum beta lactamase'}, {'cui': 'C0029235', 'cui_str': 'Organism'}, {'cui': 'C4039163', 'cui_str': 'Carbapenem resistant Enterobacteriaceae'}]","[{'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0029235', 'cui_str': 'Organism'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0205369', 'cui_str': 'Specific'}]",2797.0,0.115846,Median prevalence of multidrug-resistant organism (MDRO) carriage per NH was 50% (range: 24%-70%).,"[{'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'McKinnell', 'Affiliation': 'Department of Medicine, Infectious Disease Clinical Outcomes Research (ID-CORE), LA Biomed at Harbor-UCLA Medical Center, Torrance, CA; Los Angeles County Department of Public Health, Healthcare Outreach Unit, Los Angeles, CA; Expert Stewardship, Newport, CA. Electronic address: Dr.McKinnell@gmail.com.'}, {'ForeName': 'Loren G', 'Initials': 'LG', 'LastName': 'Miller', 'Affiliation': 'Department of Medicine, Infectious Disease Clinical Outcomes Research (ID-CORE), LA Biomed at Harbor-UCLA Medical Center, Torrance, CA.'}, {'ForeName': 'Raveena D', 'Initials': 'RD', 'LastName': 'Singh', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, University of California Irvine School of Medicine, Irvine, CA.'}, {'ForeName': 'Gabrielle', 'Initials': 'G', 'LastName': 'Gussin', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, University of California Irvine School of Medicine, Irvine, CA.'}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Kleinman', 'Affiliation': 'University of Massachusetts Amherst School of Public Health and Health Sciences, Amherst, MA.'}, {'ForeName': 'Job', 'Initials': 'J', 'LastName': 'Mendez', 'Affiliation': 'Department of Medicine, Infectious Disease Clinical Outcomes Research (ID-CORE), LA Biomed at Harbor-UCLA Medical Center, Torrance, CA.'}, {'ForeName': 'Bryn', 'Initials': 'B', 'LastName': 'Laurner', 'Affiliation': 'Department of Medicine, Infectious Disease Clinical Outcomes Research (ID-CORE), LA Biomed at Harbor-UCLA Medical Center, Torrance, CA.'}, {'ForeName': 'Tabitha D', 'Initials': 'TD', 'LastName': 'Catuna', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, University of California Irvine School of Medicine, Irvine, CA.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Heim', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, University of California Irvine School of Medicine, Irvine, CA.'}, {'ForeName': 'Raheeb', 'Initials': 'R', 'LastName': 'Saavedra', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, University of California Irvine School of Medicine, Irvine, CA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Felix', 'Affiliation': 'Department of Medicine, Infectious Disease Clinical Outcomes Research (ID-CORE), LA Biomed at Harbor-UCLA Medical Center, Torrance, CA.'}, {'ForeName': 'Crystal', 'Initials': 'C', 'LastName': 'Torres', 'Affiliation': 'Department of Medicine, Infectious Disease Clinical Outcomes Research (ID-CORE), LA Biomed at Harbor-UCLA Medical Center, Torrance, CA.'}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Chang', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, University of California Irvine School of Medicine, Irvine, CA.'}, {'ForeName': 'Marlene', 'Initials': 'M', 'LastName': 'Estevez', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, University of California Irvine School of Medicine, Irvine, CA.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Mendez', 'Affiliation': 'Department of Medicine, Infectious Disease Clinical Outcomes Research (ID-CORE), LA Biomed at Harbor-UCLA Medical Center, Torrance, CA.'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Tchakalian', 'Affiliation': 'Department of Medicine, Infectious Disease Clinical Outcomes Research (ID-CORE), LA Biomed at Harbor-UCLA Medical Center, Torrance, CA.'}, {'ForeName': 'Leah', 'Initials': 'L', 'LastName': 'Bloomfield', 'Affiliation': 'Department of Medicine, Infectious Disease Clinical Outcomes Research (ID-CORE), LA Biomed at Harbor-UCLA Medical Center, Torrance, CA.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Ceja', 'Affiliation': 'Department of Medicine, Infectious Disease Clinical Outcomes Research (ID-CORE), LA Biomed at Harbor-UCLA Medical Center, Torrance, CA.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Franco', 'Affiliation': 'Department of Medicine, Infectious Disease Clinical Outcomes Research (ID-CORE), LA Biomed at Harbor-UCLA Medical Center, Torrance, CA.'}, {'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'Miner', 'Affiliation': 'Department of Medicine, Infectious Disease Clinical Outcomes Research (ID-CORE), LA Biomed at Harbor-UCLA Medical Center, Torrance, CA.'}, {'ForeName': 'Aura', 'Initials': 'A', 'LastName': 'Hurtado', 'Affiliation': 'Department of Medicine, Infectious Disease Clinical Outcomes Research (ID-CORE), LA Biomed at Harbor-UCLA Medical Center, Torrance, CA.'}, {'ForeName': 'Ratharo', 'Initials': 'R', 'LastName': 'Hean', 'Affiliation': 'Department of Medicine, Infectious Disease Clinical Outcomes Research (ID-CORE), LA Biomed at Harbor-UCLA Medical Center, Torrance, CA.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Varasteh', 'Affiliation': 'Department of Medicine, Infectious Disease Clinical Outcomes Research (ID-CORE), LA Biomed at Harbor-UCLA Medical Center, Torrance, CA.'}, {'ForeName': 'Philip A', 'Initials': 'PA', 'LastName': 'Robinson', 'Affiliation': 'Expert Stewardship, Newport, CA; Hoag Hospital, Newport, CA.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Park', 'Affiliation': 'Department of Pathology and Laboratory Medicine, University of California, Irvine School of Medicine, Irvine, CA.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Tam', 'Affiliation': 'Division of Geriatrics, Department of Medicine, University of California Irvine, Orange, CA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Tjoa', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, University of California Irvine School of Medicine, Irvine, CA.'}, {'ForeName': 'Jiayi', 'Initials': 'J', 'LastName': 'He', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, University of California Irvine School of Medicine, Irvine, CA.'}, {'ForeName': 'Shalini', 'Initials': 'S', 'LastName': 'Agrawal', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, University of California Irvine School of Medicine, Irvine, CA.'}, {'ForeName': 'Stacey', 'Initials': 'S', 'LastName': 'Yamaguchi', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, University of California Irvine School of Medicine, Irvine, CA.'}, {'ForeName': 'Harold', 'Initials': 'H', 'LastName': 'Custodio', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, University of California Irvine School of Medicine, Irvine, CA.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Nguyen', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, University of California Irvine School of Medicine, Irvine, CA.'}, {'ForeName': 'Cassiana E', 'Initials': 'CE', 'LastName': 'Bittencourt', 'Affiliation': 'Department of Pathology and Laboratory Medicine, University of California, Irvine School of Medicine, Irvine, CA.'}, {'ForeName': 'Kaye D', 'Initials': 'KD', 'LastName': 'Evans', 'Affiliation': 'Department of Pathology and Laboratory Medicine, University of California, Irvine School of Medicine, Irvine, CA.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Mor', 'Affiliation': 'Department of Health Services, Policy and Practice, Brown University School of Public Health, Providence, RI; Center of Innovation in Long-Term Services and Supports, Veterans Affairs Medical Center, Providence VA Medical Center, Providence, RI; Center for Long-Term Care Quality and Innovation, Brown University School of Public Health, Providence, RI.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'McConeghy', 'Affiliation': 'Department of Health Services, Policy and Practice, Brown University School of Public Health, Providence, RI; Center of Innovation in Long-Term Services and Supports, Veterans Affairs Medical Center, Providence VA Medical Center, Providence, RI; Center for Long-Term Care Quality and Innovation, Brown University School of Public Health, Providence, RI.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Weinstein', 'Affiliation': 'Cook County Health and Hospitals System, Chicago, IL; Department of Medicine, Rush University Medical Center, Chicago, IL.'}, {'ForeName': 'Mary K', 'Initials': 'MK', 'LastName': 'Hayden', 'Affiliation': 'Department of Medicine, Rush University Medical Center, Chicago, IL.'}, {'ForeName': 'Nimalie D', 'Initials': 'ND', 'LastName': 'Stone', 'Affiliation': 'Division of Healthcare Quality Promotion, Centers for Disease Control and Prevention, Atlanta, GA.'}, {'ForeName': 'Karl', 'Initials': 'K', 'LastName': 'Steinberg', 'Affiliation': 'California Association of Long Term Care Medicine, Santa Clarita, CA.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Beecham', 'Affiliation': 'The National Association of Directors of Nursing Administration in Long Term Care, Springdale, OH.'}, {'ForeName': 'Jocelyn', 'Initials': 'J', 'LastName': 'Montgomery', 'Affiliation': 'California Association of Health Facilities, Sacramento, CA.'}, {'ForeName': 'Walters', 'Initials': 'W', 'LastName': 'DeAnn', 'Affiliation': 'California Association of Health Facilities, Sacramento, CA.'}, {'ForeName': 'Ellena M', 'Initials': 'EM', 'LastName': 'Peterson', 'Affiliation': 'Department of Pathology and Laboratory Medicine, University of California, Irvine School of Medicine, Irvine, CA.'}, {'ForeName': 'Susan S', 'Initials': 'SS', 'LastName': 'Huang', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, University of California Irvine School of Medicine, Irvine, CA; Department of Medicine, Health Policy Research Institute, University of California Irvine School of Medicine, Irvine, CA.'}]",Journal of the American Medical Directors Association,['10.1016/j.jamda.2020.04.007'] 1817,32569643,Effect of the SafeCare© intervention on parenting outcomes among parents in child welfare systems: A cluster randomized trial.,"Child maltreatment has long-lasting negative impacts, and interventions are needed to improve caregiver's parenting skills to prevent maltreatment. This paper reports on a randomized trial comparing the SafeCare© model to services as usual (SAU) for child-welfare referred caregivers. SafeCare is an 18-session behavioral parenting program that teaches skills in positive parent-child interactions, home safety, and child health. SAU is generally unstructured and includes support, crisis management, referrals for need, and parenting education. Teams of providers at nine sites were randomized to implement SafeCare (19 teams; 119 providers) or continue SAU (17 teams; 118 providers). Two-hundred eighty eight caregivers (193 SafeCare; 95 SAU) with children aged 0-5 who were receiving services agreed to complete a baseline and 6-month assessment. Assessments measured positive parenting behaviors, parenting stress, protective factors, and neglectful behaviors using validated scales. Participants were primarily white (74.6%), female (87.0%), and low-income (68.6%), and had a mean age of 29. Latent change score models (LCSM) using a sandwich estimator consistent with the trial design were used to examine changes in 13 outcomes. Results indicated that SafeCare had small to medium effects for improving several parenting outcomes including supporting positive child behaviors (d = 0.46), proactive parenting (d = 0.25), and two aspects of parenting stress (d = 0.28 and .30). No differential change between groups was found for other indicators, including all indicators of neglect. Parenting programs such as SafeCare offer a promising mode of intervention for child welfare systems. Scale-up of parenting programs can improve parenting, improve child outcomes, and potentially reduce maltreatment. CLINICALTRIAL.GOV REGISTRATION NUMBER: NCT02549287.",2020,Teams of providers at nine sites were randomized to implement SafeCare (19 teams; 119 providers) or continue SAU (17 teams; 118 providers).,"['Participants were primarily white (74.6%), female (87.0%), and low-income (68.6%), and had a mean age of 29', 'child-welfare referred caregivers', 'Teams of providers at nine sites were randomized to implement SafeCare (19 teams; 119 providers) or', 'parents in child welfare systems', 'Two-hundred eighty eight caregivers (193 SafeCare; 95 SAU) with children aged 0-5 who were receiving services agreed to complete a baseline and 6-month assessment']","['continue SAU', 'SafeCare']","['several parenting outcomes including supporting positive child behaviors', 'proactive parenting', 'positive parenting behaviors, parenting stress, protective factors, and neglectful behaviors using validated scales', 'parenting outcomes']","[{'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C4517855', 'cui_str': '68.6'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0008093', 'cui_str': 'Child Well Being'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C4517898', 'cui_str': '88'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0557854', 'cui_str': 'Services'}]","[{'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0008065', 'cui_str': 'Behavior, Child'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0679688', 'cui_str': 'Protective Factors'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",288.0,0.0742896,Teams of providers at nine sites were randomized to implement SafeCare (19 teams; 119 providers) or continue SAU (17 teams; 118 providers).,"[{'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Whitaker', 'Affiliation': 'Georgia State University, United States of America. Electronic address: Dwhitaker@gsu.edu.'}, {'ForeName': 'Shannon', 'Initials': 'S', 'LastName': 'Self-Brown', 'Affiliation': 'Georgia State University, United States of America.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Hayat', 'Affiliation': 'Georgia State University, United States of America.'}, {'ForeName': 'Melissa C', 'Initials': 'MC', 'LastName': 'Osborne', 'Affiliation': 'Georgia State University, United States of America.'}, {'ForeName': 'Erin A', 'Initials': 'EA', 'LastName': 'Weeks', 'Affiliation': 'Georgia State University, United States of America.'}, {'ForeName': 'Dennis E', 'Initials': 'DE', 'LastName': 'Reidy', 'Affiliation': 'Georgia State University, United States of America.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Lyons', 'Affiliation': 'Georgia State University, United States of America.'}]",Preventive medicine,['10.1016/j.ypmed.2020.106167'] 1818,32570015,Lactobacillus rhamnosus GG and HbA1c in middle age and older adults without type 2 diabetes mellitus: A preliminary randomized study.,"BACKGROUND AND AIMS Probiotic supplementation improves glycemic control in persons with diabetes and the current study examined whether these benefits extend to healthy individuals. METHODS The current study was a 90-day placebo-controlled, double-blind, randomized clinical trial of Lactobacillus rhamnosus GG in healthy middle-aged and older adults. Fasting blood glucose and HbA1c were quantified at baseline and follow up. RESULTS ANCOVA controlling for baseline values showed group differences in follow up HbA1c [F (1,90) = 8.44, p = 0.005]; HbA1c values increased in the placebo group, though remained stable in the probiotic group. CONCLUSIONS If replicated, Lactobacillus rhamnosus GG may protect against changes in glycemic control.",2020,"RESULTS ANCOVA controlling for baseline values showed group differences in follow up HbA1c [F (1,90) = 8.44, p = 0.005]; HbA1c values increased in the placebo group, though remained stable in the probiotic group. ","['middle age and older adults without type 2 diabetes mellitus', 'healthy middle-aged and older adults', 'persons with diabetes']","['placebo', 'Lactobacillus rhamnosus GG', 'Lactobacillus rhamnosus GG and HbA1c', 'Probiotic supplementation']","['glycemic control', 'HbA1c values', 'Fasting blood glucose and HbA1c']","[{'cui': 'C0026062', 'cui_str': 'Middle-age'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1629836', 'cui_str': 'Lactobacillus rhamnosus GG'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0428568', 'cui_str': 'Fasting blood glucose measurement'}]",,0.163147,"RESULTS ANCOVA controlling for baseline values showed group differences in follow up HbA1c [F (1,90) = 8.44, p = 0.005]; HbA1c values increased in the placebo group, though remained stable in the probiotic group. ","[{'ForeName': 'Victoria E', 'Initials': 'VE', 'LastName': 'Sanborn', 'Affiliation': 'Department of Psychological Sciences, Kent State University, USA. Electronic address: vsanborn@kent.edu.'}, {'ForeName': 'M Andrea', 'Initials': 'MA', 'LastName': 'Azcarate-Peril', 'Affiliation': 'Department of Medicine, Division of Gastroenterology and Hepatology, and UNC Microbiome Core, Center for Gastrointestinal Biology and Disease, School of Medicine, University of North Carolina, Chapel Hill, NC, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Gunstad', 'Affiliation': 'Department of Psychological Sciences, Kent State University, USA; Brain Health Research Institute, Kent State University, USA.'}]",Diabetes & metabolic syndrome,['10.1016/j.dsx.2020.05.034'] 1819,32570059,"Effect of photobiomodulation on salivary flow and composition, xerostomia and quality of life of patients during head and neck radiotherapy in short term follow-up: A randomized controlled clinical trial.","Xerostomia and hyposalivation are frequent conditions in patients undergoing head and neck radiotherapy, which usually lead to a worsening of quality of life. This study aimed to assess whether photobiomodulation (PBM) can minimize hyposalivation, xerostomia and qualitative changes on saliva and improve quality of life in patients undergoing radiotherapy in short-term follow-up. Twenty-one patients were randomly divided into two groups: sham group (SG) and laser group (LG). A diode laser was used for intra- (660 nm, 10 J/cm 2 , 0.28 J per point, 40 mW) and extra-oral (810 nm, 25 J/cm 2 , 0.7 J per point, 40 mW) applications over the salivary glands, three times a week, during the entire radiotherapy period. In SG, the tip of the instrument was sealed with blue rubber to prevent the passage of light. Xerostomia and pH were evaluated and unstimulated and stimulated salivary flow was determined before the start of radiotherapy (T1), after the 15th session (T2), after the end of radiotherapy (T3) and 60 days after radiotherapy (T4). Concentrations of calcium, total proteins, chloride, sodium, potassium and amylase and catalase activities were evaluated in stimulated saliva samples. Quality of life was assessed at times T1 and T4. Generalized estimating equations were used to assess differences in the outcome between times and groups. All patients showed worsening in unstimulated (p = .003) and stimulated (p < .001) salivary flow, xerostomia (p < .05) and quality of life during radiotherapy (p = .001). An increase in chloride concentrations was observed at times T3 and T4 (p < 0,05), and a reduction in amylase activity at T3 (p < .05). Unstimulated saliva pH was higher in LG than SG at T3 (p = .037). No difference between groups was noted in relation to salivary flow and composition, xerostomia or quality of life. Our results suggest that PBM may help in preserving salivary pH during radiotherapy.",2020,"All patients showed worsening in unstimulated (p = .003) and stimulated (p < .001) salivary flow, xerostomia (p < .05) and quality of life during radiotherapy (p = .001).","['patients undergoing head and neck', 'patients during head and neck radiotherapy in short term follow-up', 'patients undergoing radiotherapy in short-term follow-up', 'Twenty-one patients']","['radiotherapy', 'photobiomodulation (PBM', 'photobiomodulation', 'sham group (SG) and laser group (LG', 'diode laser', 'PBM']","['quality of life', 'Concentrations of calcium, total proteins, chloride, sodium, potassium and amylase and catalase activities', 'Unstimulated saliva pH', 'relation to salivary flow and composition, xerostomia or quality of life', 'amylase activity', 'Quality of life', 'salivary flow and composition, xerostomia and quality of life', 'chloride concentrations', 'Xerostomia and pH', 'salivary flow, xerostomia']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0460004', 'cui_str': 'Structure of head and/or neck'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C3715213', 'cui_str': '21'}]","[{'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0392254', 'cui_str': 'Semiconductor laser device'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0555903', 'cui_str': 'Total protein measurement'}, {'cui': 'C0008203', 'cui_str': 'Chloride salt'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0032821', 'cui_str': 'Potassium'}, {'cui': 'C0002712', 'cui_str': 'Amylases'}, {'cui': 'C0007367', 'cui_str': 'CATALASE'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0439819', 'cui_str': 'Unstimulated'}, {'cui': 'C0036087', 'cui_str': 'Saliva'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0043352', 'cui_str': 'Xerostomia'}]",21.0,0.0663906,"All patients showed worsening in unstimulated (p = .003) and stimulated (p < .001) salivary flow, xerostomia (p < .05) and quality of life during radiotherapy (p = .001).","[{'ForeName': 'Gabriel Campos', 'Initials': 'GC', 'LastName': 'Louzeiro', 'Affiliation': 'School of Health and Life Sciences, Oral Medicine Division, Pontifical Catholic University of Rio Grande do Sul- PUCRS, Porto Alegre, Rio Grande do Sul, Brazil.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Cherubini', 'Affiliation': 'School of Health and Life Sciences, Oral Medicine Division, Pontifical Catholic University of Rio Grande do Sul- PUCRS, Porto Alegre, Rio Grande do Sul, Brazil.'}, {'ForeName': 'Maria Antonia Zancanaro', 'Initials': 'MAZ', 'LastName': 'de Figueiredo', 'Affiliation': 'School of Health and Life Sciences, Oral Medicine Division, Pontifical Catholic University of Rio Grande do Sul- PUCRS, Porto Alegre, Rio Grande do Sul, Brazil.'}, {'ForeName': 'Fernanda Gonçalves', 'Initials': 'FG', 'LastName': 'Salum', 'Affiliation': 'School of Health and Life Sciences, Oral Medicine Division, Pontifical Catholic University of Rio Grande do Sul- PUCRS, Porto Alegre, Rio Grande do Sul, Brazil. Electronic address: fernanda.salum@pucrs.br.'}]","Journal of photochemistry and photobiology. B, Biology",['10.1016/j.jphotobiol.2020.111933'] 1820,32570126,A Prospective Study Investigating Blood Patch Pleurodesis for Postoperative Air Leaks After Pulmonary Resection.,"BACKGROUND Prolonged air leaks (PALs) after lung resection are one of the most common complications in thoracic surgery. Several options are available to treat PALs. The autologous blood patch pleurodesis is commonly used but has not been thoroughly investigated. MATERIALS AND METHODS We conducted a prospective randomized study including all consecutive patients with PALs after pulmonary resections. Patients were randomized to either having received pleurodesis by injecting 100 mL autologous blood at d 5 and 6 (Group A) or being placed under observation (Group B). Patients from either group undergoing revisions were further investigated by a post hoc analysis and formed Group C. RESULTS A total of 24 patients were included: 10 patients were randomized to group A and 14 to group B. Six patients (3 from each group) underwent surgical revision and were included in Group C. Groups A and B did not differ in baseline characteristics. The median time to drainage removal was 9 d (range: 5-23 d) in Group A; 9 d (range: 2-20 d) in Group B; and 6 d in Group C (range: 3-10 d), (A/B versus C, P < 0.04; A versus B was not significant). CONCLUSIONS There is no evidence indicating a benefit for blood patch pleurodeses in patients undergoing lung resections and presenting with postoperative PALs for more than 5 d. An early operative closure of postoperative air leakage seems to be more effective.",2020,"The median time to drainage removal was 9 d (range: 5-23 d) in Group A; 9 d (range: 2-20 d) in Group B; and 6 d in Group C (range: 3-10 d), (A/B versus C, P ","['all consecutive patients with PALs after pulmonary resections', 'patients undergoing lung resections and presenting with postoperative PALs for more than 5\xa0d', '24 patients were included: 10 patients']","['pleurodesis by injecting 100\xa0mL autologous blood at d 5 and 6 (Group A) or being placed under observation', 'surgical revision', 'Blood Patch Pleurodesis']","['Postoperative Air Leaks', 'blood patch pleurodeses', 'median time to drainage removal']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0332234', 'cui_str': 'Leaking'}, {'cui': 'C0396565', 'cui_str': 'Lung excision'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0189557', 'cui_str': 'Pleurodesis'}, {'cui': 'C1720154', 'cui_str': 'Inject'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0035110', 'cui_str': 'Reoperation'}, {'cui': 'C0332461', 'cui_str': 'Plaque'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0332234', 'cui_str': 'Leaking'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0332461', 'cui_str': 'Plaque'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0015252', 'cui_str': 'Removal'}]",24.0,0.10955,"The median time to drainage removal was 9 d (range: 5-23 d) in Group A; 9 d (range: 2-20 d) in Group B; and 6 d in Group C (range: 3-10 d), (A/B versus C, P ","[{'ForeName': 'Till', 'Initials': 'T', 'LastName': 'Ploenes', 'Affiliation': 'Department of Thoracic Surgery and Thoracic Endoscopy, Ruhrlandklinik, West German Lung Center, University Hospital Essen, University Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Ioanis', 'Initials': 'I', 'LastName': 'Kyritsis', 'Affiliation': 'Department of Thoracic Surgery and Thoracic Endoscopy, Ruhrlandklinik, West German Lung Center, University Hospital Essen, University Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Khaled', 'Initials': 'K', 'LastName': 'Mardanzai', 'Affiliation': 'Department of Thoracic Surgery and Thoracic Endoscopy, Ruhrlandklinik, West German Lung Center, University Hospital Essen, University Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Muhmann', 'Affiliation': 'Department of Thoracic Surgery and Thoracic Endoscopy, Ruhrlandklinik, West German Lung Center, University Hospital Essen, University Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Langehegermann', 'Affiliation': 'Department of Thoracic Surgery and Thoracic Endoscopy, Ruhrlandklinik, West German Lung Center, University Hospital Essen, University Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Alexis', 'Initials': 'A', 'LastName': 'Slama', 'Affiliation': 'Department of Thoracic Surgery and Thoracic Endoscopy, Ruhrlandklinik, West German Lung Center, University Hospital Essen, University Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Balazs', 'Initials': 'B', 'LastName': 'Hegedüs', 'Affiliation': 'Department of Thoracic Surgery and Thoracic Endoscopy, Ruhrlandklinik, West German Lung Center, University Hospital Essen, University Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Clemens', 'Initials': 'C', 'LastName': 'Aigner', 'Affiliation': 'Department of Thoracic Surgery and Thoracic Endoscopy, Ruhrlandklinik, West German Lung Center, University Hospital Essen, University Duisburg-Essen, Essen, Germany. Electronic address: clemens.aigner@rlk.uk-essen.de.'}]",The Journal of surgical research,['10.1016/j.jss.2020.05.012'] 1821,32546251,A comparison of two personalization and adaptive cognitive rehabilitation approaches: a randomized controlled trial with chronic stroke patients.,"BACKGROUND Paper-and-pencil tasks are still widely used for cognitive rehabilitation despite the proliferation of new computer-based methods, like VR-based simulations of ADL's. Studies have established construct validity of VR assessment tools with their paper-and-pencil version by demonstrating significant associations with their traditional construct-driven measures. However, VR rehabilitation intervention tools are mostly developed to include mechanisms such as personalization and adaptation, elements that are disregarded in their paper-and-pencil counterparts, which is a strong limitation of comparison studies. Here we compare the clinical impact of a personalized and adapted paper-and-pencil training and a content equivalent and more ecologically valid VR-based ADL's simulation. METHODS We have performed a trial with 36 stroke patients comparing Reh@City v2.0 (adaptive cognitive training through everyday tasks VR simulations) with Task Generator (TG: content equivalent and adaptive paper-and-pencil training). The intervention comprised 12 sessions, with a neuropsychological assessment pre, post-intervention and follow-up, having as primary outcomes: general cognitive functioning (assessed by the Montreal Cognitive Assessment - MoCA), attention, memory, executive functions and language specific domains. RESULTS A within-group analysis revealed that the Reh@City v2.0 improved general cognitive functioning, attention, visuospatial ability and executive functions. These improvements generalized to verbal memory, processing speed and self-perceived cognitive deficits specific assessments. TG only improved in orientation domain on the MoCA, and specific processing speed and verbal memory outcomes. However, at follow-up, processing speed and verbal memory improvements were maintained, and a new one was revealed in language. A between-groups analysis revealed Reh@City v2.0 superiority in general cognitive functioning, visuospatial ability, and executive functions on the MoCA. CONCLUSIONS The Reh@City v2.0 intervention with higher ecological validity revealed higher effectiveness with improvements in different cognitive domains and self-perceived cognitive deficits in everyday life, and the TG intervention retained fewer cognitive gains for longer. TRIAL REGISTRATION The trial is registered at ClinicalTrials.gov, number NCT02857803. Registered 5 August 2016, .",2020,"A between-groups analysis revealed Reh@City v2.0 superiority in general cognitive functioning, visuospatial ability, and executive functions on the MoCA. CONCLUSIONS The Reh@City v2.0 intervention with higher ecological validity revealed higher effectiveness with improvements in different cognitive domains and self-perceived cognitive deficits in everyday life, and the TG intervention retained fewer cognitive gains for longer. ","['36 stroke patients comparing', 'chronic stroke patients']","['two personalization and adaptive cognitive rehabilitation approaches', 'Reh@City v2.0 (adaptive cognitive training through everyday tasks VR simulations) with Task Generator (TG: content equivalent and adaptive paper-and-pencil training', 'neuropsychological assessment pre, post-intervention and follow-up, having as primary outcomes: general cognitive functioning (assessed by the Montreal Cognitive Assessment - MoCA), attention, memory, executive functions and language specific domains', ""personalized and adapted paper-and-pencil training and a content equivalent and more ecologically valid VR-based ADL's simulation""]","['MoCA, and specific processing speed and verbal memory outcomes', 'general cognitive functioning, attention, visuospatial ability and executive functions', 'processing speed and verbal memory improvements', 'verbal memory, processing speed and self-perceived cognitive deficits specific assessments', 'cognitive gains', 'general cognitive functioning, visuospatial ability, and executive functions']","[{'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3536593', 'cui_str': 'Chronic cerebrovascular accident'}]","[{'cui': 'C0870303', 'cui_str': 'Cognitive rehabilitation'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0441661', 'cui_str': 'Everyday tasks'}, {'cui': 'C0237638', 'cui_str': 'Generator'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0030351', 'cui_str': 'Paper'}, {'cui': 'C0441059', 'cui_str': 'Pencil'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0027902', 'cui_str': 'Neuropsychological testing'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}, {'cui': 'C4555213', 'cui_str': 'Assessment using Montreal cognitive assessment'}, {'cui': 'C0025750', 'cui_str': ""3,3'-Dichloro-4,4'-Diaminodiphenylmethane""}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}]","[{'cui': 'C0025750', 'cui_str': ""3,3'-Dichloro-4,4'-Diaminodiphenylmethane""}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0582591', 'cui_str': 'Processing speed'}, {'cui': 'C0561770', 'cui_str': 'Verbal memory observable'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0009241', 'cui_str': 'Cognitive disorder'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",36.0,0.0444724,"A between-groups analysis revealed Reh@City v2.0 superiority in general cognitive functioning, visuospatial ability, and executive functions on the MoCA. CONCLUSIONS The Reh@City v2.0 intervention with higher ecological validity revealed higher effectiveness with improvements in different cognitive domains and self-perceived cognitive deficits in everyday life, and the TG intervention retained fewer cognitive gains for longer. ","[{'ForeName': 'Ana Lúcia', 'Initials': 'AL', 'LastName': 'Faria', 'Affiliation': 'Madeira Interactive Technologies Institute, Universidade da Madeira, Funchal, Portugal. ana.faria@m-iti.org.'}, {'ForeName': 'Maria Salomé', 'Initials': 'MS', 'LastName': 'Pinho', 'Affiliation': 'Faculdade de Psicologia e de Ciências da Educação, Universidade de Coimbra, Coimbra, Portugal.'}, {'ForeName': 'Sergi', 'Initials': 'S', 'LastName': 'Bermúdez I Badia', 'Affiliation': 'Madeira Interactive Technologies Institute, Universidade da Madeira, Funchal, Portugal.'}]",Journal of neuroengineering and rehabilitation,['10.1186/s12984-020-00691-5'] 1822,32544572,"A 10-week yoga practice has no effect on cognition, but improves balance and motor learning by attenuating brain-derived neurotrophic factor levels in older adults.","Despite studies investigating the effect of yoga on cognitive and motor functioning in older adults, the effect on dual-task performance and motor learning and the specific mechanisms underlying the positive effect of yoga remain unclear. Thus, the aim of this study was to investigate the effects of yoga on cognition, balance under single- and dual-task conditions, and motor learning. The potential role of brain-derived neurotrophic factor (BDNF) in induced improvement was also explored. Participants aged 60-79 years were randomized to either a control group (n = 15) or a yoga group (n = 18) for a 10-week period. The yoga group received 90-min duration yoga classes two times per week. Changes in cognition, balance under single- and dual-task conditions, and learning fast and accurate reaching movements were assessed. Yoga practice decreased (P < 0.05) the velocity vector of the center of pressure under single- and dual-task conditions, whereas no changes in cognitive performance were observed. Although reaction and movement times during learning were decreased in both groups (P < 0.05), a faster reaction time (P < 0.05) and shorter movement time (P < 0.05) were observed in the yoga group than in the control group. Significant moderate relationships (P < 0.05) between changes in BDNF levels and functional improvements were observed. Thus, 10 weeks of yoga practice resulted in improved balance and learning in the speed-accuracy motor task that were mediated by increased BDNF levels, but had no impact on cognition in older adults.",2020,"Although reaction and movement times during learning were decreased in both groups (P < 0.05), a faster reaction time (P < 0.05) and shorter movement time (P < 0.05) were observed in the yoga group than in the control group.","['Participants aged 60-79\u202fyears', 'older adults']","['brain-derived neurotrophic factor (BDNF', 'control group (n\u202f=\u202f15) or a yoga group']","['cognitive performance', 'Yoga practice', 'BDNF levels', 'shorter movement time', 'reaction and movement times during learning', 'velocity vector of the center of pressure under single- and dual-task conditions', 'Changes in cognition, balance under single- and dual-task conditions, and learning fast and accurate reaching movements', 'balance and learning', 'cognition, balance under single- and dual-task conditions, and motor learning', 'BDNF levels and functional improvements', 'faster reaction time']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0012656', 'cui_str': 'Infectious Disease Vectors'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}]",,0.0174528,"Although reaction and movement times during learning were decreased in both groups (P < 0.05), a faster reaction time (P < 0.05) and shorter movement time (P < 0.05) were observed in the yoga group than in the control group.","[{'ForeName': 'Agnė', 'Initials': 'A', 'LastName': 'Čekanauskaitė', 'Affiliation': 'Department of Health Promotion and Rehabilitation, Lithuanian Sports University, Kaunas, Lithuania. Electronic address: agne.cekanauskaite@lsu.lt.'}, {'ForeName': 'Albertas', 'Initials': 'A', 'LastName': 'Skurvydas', 'Affiliation': 'Department of Health Promotion and Rehabilitation, Lithuanian Sports University, Kaunas, Lithuania; Institute of Sports Science and Innovations, Lithuanian Sports University, Kaunas, Lithuania.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Žlibinaitė', 'Affiliation': 'Department of Health Promotion and Rehabilitation, Lithuanian Sports University, Kaunas, Lithuania.'}, {'ForeName': 'Dalia', 'Initials': 'D', 'LastName': 'Mickevičienė', 'Affiliation': 'Department of Health Promotion and Rehabilitation, Lithuanian Sports University, Kaunas, Lithuania; Institute of Sports Science and Innovations, Lithuanian Sports University, Kaunas, Lithuania.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Kilikevičienė', 'Affiliation': 'Department of Health Promotion and Rehabilitation, Lithuanian Sports University, Kaunas, Lithuania; Institute of Sports Science and Innovations, Lithuanian Sports University, Kaunas, Lithuania.'}, {'ForeName': 'Rima', 'Initials': 'R', 'LastName': 'Solianik', 'Affiliation': 'Department of Health Promotion and Rehabilitation, Lithuanian Sports University, Kaunas, Lithuania; Institute of Sports Science and Innovations, Lithuanian Sports University, Kaunas, Lithuania.'}]",Experimental gerontology,['10.1016/j.exger.2020.110998'] 1823,32544700,Time course of drug-related treatment-emergent adverse side effects of brivaracetam.,"OBJECTIVE Treatment-emergent adverse events (TEAEs) in clinical trials are typically reported for the full duration of the treatment period including titration and maintenance. Drug-related central nervous system (CNS) TEAEs are common with antiseizure medications (ASMs) and can affect drug tolerability. In this report, we test the hypothesis that drug-related CNS TEAEs have early onset and decrease with time. Unlike prior ASM clinical trials, a novel design was used for brivaracetam (BRV) without initial drug titration allowing assessment of habituation to TEAEs separate from dose titration. METHODS Data were pooled from three studies (N01252 [NCT00490035], N01253 [NCT00464269], N01358 [NCT01261325]) in adult patients (≥16 years of age) with focal seizures receiving BRV adjunctive therapy. This post hoc analysis reports data on the prevalence and incidence of all drug-related CNS TEAEs and all TEAEs over time in patients who received BRV doses of 50-200 mg/day (without titration) vs. placebo during a 12-week treatment period. RESULTS A total of 1262 patients received the following: placebo (n = 459), BRV 50 mg/day (n = 200), BRV 100 mg/day (n = 353), and BRV 200 mg/day (n = 250). Both the incidence (p < .0001) and prevalence (p < .0001) of drug-related CNS TEAEs (all with frequency ≥ 5%) changed across time with peak TEAEs in week 1 then significantly reducing over the first 6 weeks for prevalence and the first 3 weeks for incidence. CONCLUSIONS Drug-related CNS TEAEs occurred early and substantially habituated over several weeks. TEAEs of ASMs might be better represented by division into early and late phases to guide clinician monitoring and patient expectations.",2020,"Both the incidence (p < .0001) and prevalence (p < .0001) of drug-related CNS TEAEs (all with frequency ≥ 5%) changed across time with peak TEAEs in week 1 then significantly reducing over the first 6 weeks for prevalence and the first 3 weeks for incidence. ","['1262 patients', 'adult patients (≥16\u202fyears of age) with focal seizures receiving BRV adjunctive therapy']","['Drug-related central nervous system (CNS', 'brivaracetam', 'placebo']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0751495', 'cui_str': 'Partial seizure'}, {'cui': 'C1699861', 'cui_str': 'Brivaracetam'}, {'cui': 'C0677850', 'cui_str': 'Adjuvant therapy'}]","[{'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C3540014', 'cui_str': 'CENTRAL NERVOUS SYSTEM'}, {'cui': 'C1699861', 'cui_str': 'Brivaracetam'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],1262.0,0.10034,"Both the incidence (p < .0001) and prevalence (p < .0001) of drug-related CNS TEAEs (all with frequency ≥ 5%) changed across time with peak TEAEs in week 1 then significantly reducing over the first 6 weeks for prevalence and the first 3 weeks for incidence. ","[{'ForeName': 'Kimford J', 'Initials': 'KJ', 'LastName': 'Meador', 'Affiliation': 'Department of Neurology and Neurological Sciences, Stanford University, Stanford, CA, USA. Electronic address: kmeador@stanford.edu.'}, {'ForeName': 'Cedric', 'Initials': 'C', 'LastName': 'Laloyaux', 'Affiliation': 'UCB Pharma, Brussels, Belgium. Electronic address: cedric.laloyaux@ucb.com.'}, {'ForeName': 'Sami', 'Initials': 'S', 'LastName': 'Elmoufti', 'Affiliation': 'UCB Pharma, Raleigh, NC, USA. Electronic address: sami.elmoufti@ucb.com.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Gasalla', 'Affiliation': 'UCB Pharma, Monheim am Rhein, Germany. Electronic address: teresa.gasalla@ucb.com.'}, {'ForeName': 'Jesse', 'Initials': 'J', 'LastName': 'Fishman', 'Affiliation': 'UCB Pharma, Smyrna, GA, USA. Electronic address: jfishman@its.jnj.com.'}, {'ForeName': 'Melinda S', 'Initials': 'MS', 'LastName': 'Martin', 'Affiliation': 'UCB Pharma, Smyrna, GA, USA. Electronic address: melinda.martin@ucb.com.'}, {'ForeName': 'Pavel', 'Initials': 'P', 'LastName': 'Klein', 'Affiliation': 'Mid-Atlantic Epilepsy and Sleep Center, Bethesda, MD, USA. Electronic address: kleinp@epilepsydc.com.'}]",Epilepsy & behavior : E&B,['10.1016/j.yebeh.2020.107212'] 1824,32552153,"Safety and tolerability of empagliflozin and linagliptin combination therapy in patients with type 2 diabetes mellitus: a pooled analysis of data from five randomized, controlled clinical trials.","OBJECTIVES The fixed-dose combination of empagliflozin and linagliptin, two glucose-lowering drugs prescribed for type 2 diabetes mellitus, has demonstrated good tolerability in phase III clinical trials. To further evaluate the safety profile of this combination, the data from these trials were pooled and analyzed. METHODS This was a post-hoc pooled analysis of five randomized, double-blind, clinical trials of the empagliflozin/linagliptin fixed-dose combination. Data for adverse events and laboratory parameters were evaluated. RESULTS The analysis included 2895 patients: 1410, 1015, and 470 receiving the empagliflozin/linagliptin combination, empagliflozin monotherapy, and linagliptin monotherapy, respectively. Overall, the incidence of adverse events with the empagliflozin/linagliptin combination was similar to that with empagliflozin or linagliptin alone. Fewer than 2% of patients experienced hypoglycemia, and its incidence was similar across treatment groups. Genital infections occurred in more patients receiving empagliflozin/linagliptin (3.0%) or empagliflozin monotherapy (5.1%) than in those receiving linagliptin monotherapy (1.9%). No cases of Fournier's gangrene, diabetic ketoacidosis, or pemphigoid occurred, and no clinically relevant mean changes in laboratory parameters were noted. CONCLUSION The safety profile of the fixed-dose combination of empagliflozin and linagliptin was similar to the individual monotherapies. No new safety signals were identified.",2020,Genital infections occurred in more patients receiving empagliflozin/linagliptin (3.0%) or empagliflozin monotherapy (5.1%) than in those receiving linagliptin monotherapy (1.9%).,"['patients with type 2 diabetes mellitus', 'type 2 diabetes mellitus', '2895 patients: 1410, 1015, and 470 receiving the']","['empagliflozin monotherapy', 'empagliflozin/linagliptin combination, empagliflozin monotherapy, and linagliptin monotherapy', 'empagliflozin', 'empagliflozin and linagliptin', 'empagliflozin and linagliptin, two glucose-lowering drugs', 'empagliflozin/linagliptin', 'linagliptin monotherapy', 'empagliflozin and linagliptin combination therapy', 'empagliflozin/linagliptin fixed-dose combination', 'linagliptin']","['Safety and tolerability', 'hypoglycemia', ""Fournier's gangrene, diabetic ketoacidosis, or pemphigoid"", 'Genital infections', 'adverse events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}]","[{'cui': 'C3490348', 'cui_str': 'empagliflozin'}, {'cui': 'C3871442', 'cui_str': 'linagliptin and empagliflozin'}, {'cui': 'C2746078', 'cui_str': 'Linagliptin'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0009429', 'cui_str': 'Combination therapy'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0017086', 'cui_str': 'Gangrene'}, {'cui': 'C0011880', 'cui_str': 'Diabetic ketoacidosis'}, {'cui': 'C0030805', 'cui_str': 'Bullous pemphigoid'}, {'cui': 'C0729552', 'cui_str': 'Genital infection'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",2895.0,0.279202,Genital infections occurred in more patients receiving empagliflozin/linagliptin (3.0%) or empagliflozin monotherapy (5.1%) than in those receiving linagliptin monotherapy (1.9%).,"[{'ForeName': 'Hirotaka', 'Initials': 'H', 'LastName': 'Watada', 'Affiliation': 'Department of Metabolism and Endocrinology, Juntendo University Graduate School of Medicine , Tokyo, Japan.'}, {'ForeName': 'Toshimasa', 'Initials': 'T', 'LastName': 'Yamauchi', 'Affiliation': 'Department of Diabetes and Metabolic Disease, Graduate School of Medicine, Tokyo University , Tokyo, Japan.'}, {'ForeName': 'Fumiko', 'Initials': 'F', 'LastName': 'Yamamoto', 'Affiliation': 'Medicine Division, Nippon Boehringer Ingelheim Co. Ltd , Tokyo, Japan.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Taniguchi', 'Affiliation': 'Biostatistics & Data Science, Nippon Boehringer Ingelheim Co. Ltd , Tokyo, Japan.'}, {'ForeName': 'Larisa', 'Initials': 'L', 'LastName': 'Yarush', 'Affiliation': 'Global Pharmacovigilance, Boehringer Ingelheim Pharmaceuticals, Inc ., Ridgefield, CT, USA.'}, {'ForeName': 'Clemens', 'Initials': 'C', 'LastName': 'Heilmann', 'Affiliation': 'Global Medical Affairs, Boehringer Ingelheim International GmbH , Ingelheim, Germany.'}, {'ForeName': 'Atsutaka', 'Initials': 'A', 'LastName': 'Yasui', 'Affiliation': 'Medicine Division, Nippon Boehringer Ingelheim Co. Ltd , Tokyo, Japan.'}]",Expert opinion on drug safety,['10.1080/14740338.2020.1782884'] 1825,32552775,"The ReWalk ReStore™ soft robotic exosuit: a multi-site clinical trial of the safety, reliability, and feasibility of exosuit-augmented post-stroke gait rehabilitation.","BACKGROUND Atypical walking in the months and years after stroke constrain community reintegration and reduce mobility, health, and quality of life. The ReWalk ReStore™ is a soft robotic exosuit designed to assist the propulsion and ground clearance subtasks of post-stroke walking by actively assisting paretic ankle plantarflexion and dorsiflexion. Previous proof-of-concept evaluations of the technology demonstrated improved gait mechanics and energetics and faster and farther walking in users with post-stroke hemiparesis. We sought to determine the safety, reliability, and feasibility of using the ReStore™ during post-stroke rehabilitation. METHODS A multi-site clinical trial (NCT03499210) was conducted in preparation for an application to the United States Food and Drug Administration (FDA). The study included 44 users with post-stroke hemiparesis who completed up to 5 days of training with the ReStore™ on the treadmill and over ground. In addition to primary and secondary endpoints of safety and device reliability across all training activities, an exploratory evaluation of the effect of multiple exposures to using the device on users' maximum walking speeds with and without the device was conducted prior to and following the five training visits. RESULTS All 44 study participants completed safety and reliability evaluations. Thirty-six study participants completed all five training days. No device-related falls or serious adverse events were reported. A low rate of device malfunctions was reported by clinician-operators. Regardless of their reliance on ancillary assistive devices, after only 5 days of walking practice with the device, study participants increased both their device-assisted (Δ: 0.10 ± 0.03 m/s) and unassisted (Δ: 0.07 ± 0.03 m/s) maximum walking speeds (P's < 0.05). CONCLUSIONS When used under the direction of a licensed physical therapist, the ReStore™ soft exosuit is safe and reliable for use during post-stroke gait rehabilitation to provide targeted assistance of both paretic ankle plantarflexion and dorsiflexion during treadmill and overground walking. TRIAL REGISTRATION NCT03499210. Prospectively registered on March 28, 2018.",2020,Previous proof-of-concept evaluations of the technology demonstrated improved gait mechanics and energetics and faster and farther walking in users with post-stroke hemiparesis.,"['users with post-stroke hemiparesis', '44 users with post-stroke hemiparesis who completed up to 5 days of training with the ReStore™ on the treadmill and over ground']",['exosuit-augmented post-stroke gait rehabilitation'],"['safety and reliability evaluations', 'mobility, health, and quality of life', 'gait mechanics and energetics and faster and farther walking', 'No device-related falls or serious adverse events', 'maximum walking speeds', ""safety and device reliability across all training activities, an exploratory evaluation of the effect of multiple exposures to using the device on users' maximum walking speeds""]","[{'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0018989', 'cui_str': 'Hemiparesis'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}]","[{'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0035035', 'cui_str': 'Reliability (Epidemiology)'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0376706', 'cui_str': 'Mechanics'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0040606', 'cui_str': 'Training Activities'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}]",44.0,0.124064,Previous proof-of-concept evaluations of the technology demonstrated improved gait mechanics and energetics and faster and farther walking in users with post-stroke hemiparesis.,"[{'ForeName': 'Louis N', 'Initials': 'LN', 'LastName': 'Awad', 'Affiliation': 'Department of Physical Therapy & Athletic Training, Boston University, Boston, MA, USA. louawad@bu.edu.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Esquenazi', 'Affiliation': 'Department of PM&R, MossRehab and Einstein Healthcare Network, Elkins Park, PA, USA.'}, {'ForeName': 'Gerard E', 'Initials': 'GE', 'LastName': 'Francisco', 'Affiliation': 'Department of PM&R, University of Texas McGovern Medical School, TIRR Memorial Hermann, Houston, TX, USA.'}, {'ForeName': 'Karen J', 'Initials': 'KJ', 'LastName': 'Nolan', 'Affiliation': 'Center for Mobility and Rehabilitation Engineering, Kessler Foundation, West Orange, NJ, USA.'}, {'ForeName': 'Arun', 'Initials': 'A', 'LastName': 'Jayaraman', 'Affiliation': 'Department of PM&R, Northwestern University, Chicago, IL, USA. ajayaraman@sralab.org.'}]",Journal of neuroengineering and rehabilitation,['10.1186/s12984-020-00702-5'] 1826,32553996,"The effects of a nurse-led lifestyle intervention program on cardiovascular risk, self-efficacy and health promoting behaviours among patients with metabolic syndrome: Randomized controlled trial.","BACKGROUND Metabolic syndrome is a cluster of cardio-metabolic risk factors and a major burden for public health due to its increasing prevalence and adverse effects on cardiovascular health. Lifestyle modification is the first-line intervention for metabolic syndrome management. However, adopting healthy behaviours is challenging among patients with metabolic syndrome. OBJECTIVE To examine the effects of a nurse-led lifestyle intervention program on cardiovascular risks, self-efficacy and the implementation of health promoting behaviours. DESIGN A two-armed randomized controlled trial. SETTINGS AND PARTICIPANTS A total of 173 patients that satisfied the metabolic syndrome definition of International Diabetes Federation was recruited from a hospital in North China. METHODS The participants were randomly assigned to either attend the lifestyle interventions (n = 86) or receive usual care from the study hospital (n = 87). The lifestyle intervention followed the framework of Health Promotion Model and consisted of one face-to-face education session (30-40 min), one educational booklet and six telephone follow-ups (bi-weekly, 20-30 min per call) in three months. The Framingham 10-year risk score was calculated to measure the participants' cardiovascular risks at baseline and 3-month. The Self-rated Abilities for Health Practices and Health Promoting Lifestyle Profile II was employed to measure the self-efficacy and health promoting behaviours at baseline, 1-month, and 3-month. The generalized estimating equation model was employed to examine the effects of the lifestyle intervention program. RESULTS No difference was detected in the baseline characteristics between the two groups. Decreased cardiovascular risk was found in the lifestyle intervention group, but no significant group-by-time effect was detected. The self-efficacy for nutrition, stress dimension and sum score of health promoting behaviours revealed significant improvements at 1-month (all p < 0.05). Significant improvements were also detected in all subscales, total scale of self-efficacy, all dimensions and the sum score of health promoting behaviours at 3-month (all p < 0.05). CONCLUSIONS The nurse-led Health Promotion Model guided lifestyle intervention program effectively improved the self-efficacy and implementation of health promoting behaviours in patients with metabolic syndrome. We recommend that nurses apply lifestyle interventions in routine care for patients with metabolic syndrome. Tweetable abstract: The RCT revealed that nurse-led lifestyle intervention was effective to improve self-efficacy and healthy behaviours among 173 MetS patients.",2020,"The self-efficacy for nutrition, stress dimension and sum score of health promoting behaviours revealed significant improvements at 1-month (all p < 0.05).","['173 patients that satisfied the metabolic syndrome definition of International Diabetes Federation was recruited from a hospital in North China', 'patients with metabolic syndrome', '173 MetS patients']","['nurses apply lifestyle interventions', 'nurse-led lifestyle intervention program', 'lifestyle intervention followed the framework of Health Promotion Model and consisted of one face-to-face education session (30-40\xa0min), one educational booklet and six telephone follow-ups', 'lifestyle interventions (n\xa0=\xa086) or receive usual care from the study hospital', 'Tweetable abstract']","['cardiovascular risks, self-efficacy', 'cardiovascular risk', 'cardiovascular risk, self-efficacy and health promoting behaviours', 'subscales, total scale of self-efficacy, all dimensions and the sum score of health promoting behaviours', 'self-efficacy and healthy behaviours', 'Framingham 10-year risk score', 'self-efficacy and implementation of health promoting behaviours', 'self-efficacy for nutrition, stress dimension and sum score of health promoting behaviours']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C3539107', 'cui_str': 'Definition'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0018738', 'cui_str': 'Health promotion'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0178941', 'cui_str': 'Telephone follow-up'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0000857', 'cui_str': 'Abstracting as Topic'}]","[{'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0517496', 'cui_str': 'Health promotion behavior'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0038435', 'cui_str': 'Stress'}]",173.0,0.0272669,"The self-efficacy for nutrition, stress dimension and sum score of health promoting behaviours revealed significant improvements at 1-month (all p < 0.05).","[{'ForeName': 'Xujuan', 'Initials': 'X', 'LastName': 'Zheng', 'Affiliation': 'School of Nursing, Shenzhen University, No.1066 Xueyuan Road, Nanshan District, Shenzhen 518055, China. Electronic address: zhengxujuan@szu.edu.cn.'}, {'ForeName': 'Hongbo', 'Initials': 'H', 'LastName': 'Yu', 'Affiliation': ""Department of Endocrinology, Pingdu People's Hospital, Qingdao, China. Electronic address: yuhongbo.doc@163.com.""}, {'ForeName': 'Xichenhui', 'Initials': 'X', 'LastName': 'Qiu', 'Affiliation': 'School of Nursing, Shenzhen University, No.1066 Xueyuan Road, Nanshan District, Shenzhen 518055, China. Electronic address: qiuxichenhui@163.com.'}, {'ForeName': 'Sek Ying', 'Initials': 'SY', 'LastName': 'Chair', 'Affiliation': 'The Nethersole School of Nursing, The Chinese University of Hong Kong, Shatin, N.T., Hong Kong. Electronic address: sychair@cuhk.edu.hk.'}, {'ForeName': 'Eliza Mi-Ling', 'Initials': 'EM', 'LastName': 'Wong', 'Affiliation': 'School of Nursing, The Hong Kong Polytechnic University. Hung Hom, Kowloon, Hong Kong. Electronic address: eliza.wong@polyu.edu.hk.'}, {'ForeName': 'Qun', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': 'School of Nursing, Shenzhen University, No.1066 Xueyuan Road, Nanshan District, Shenzhen 518055, China. Electronic address: qunwang@szu.edu.cn.'}]",International journal of nursing studies,['10.1016/j.ijnurstu.2020.103638'] 1827,32554025,swCRTdesign: An R Package for Stepped Wedge Trial Design and Analysis.,"BACKGROUND AND OBJECTIVE Stepped wedge trials (SWTs) are a type of cluster-randomized trial that are commonly used to evaluate health care interventions. Most SWT-related software packages have restrictive assumptions about the study design and correlation structure of the data. The objective of this paper is to present a package and corresponding web-based graphical user interface (GUI) that provide researchers with another, more flexible option for SWT design and analysis. METHODS We developed an R package swCRTdesign ('stepped wedge Cluster Randomized Trial design'), which uses a random effects model to account for correlation in the data induced by a SWT design. Possible sources of correlation include clusters, time within clusters, and treatment within clusters. RESULTS swCRTdesign allows a user to calculate power, simulate SWT data to streamline simulation studies (e.g. to estimate power), and create descriptive summaries and plots. Additionally, a GUI, developed using shiny, is available to calculate power and create power curves and design plots. CONCLUSIONS The swCRTdesign package accommodates a wide variety of SWT designs, and makes it easy to account for some sources of correlation which are not found in other packages. The user-friendly web-based GUI makes some swCRTdesign features accessible to researchers not familiar with R. These two resources will make appropriately complex SWT calculations more accessible to scientists from a wide variety of backgrounds.",2020,"We developed an R package swCRTdesign ('stepped wedge Cluster Randomized Trial design'), which uses a random effects model to account for correlation in the data induced by a SWT design.",[],['swCRTdesign'],[],[],[],[],,0.150645,"We developed an R package swCRTdesign ('stepped wedge Cluster Randomized Trial design'), which uses a random effects model to account for correlation in the data induced by a SWT design.","[{'ForeName': 'Emily C', 'Initials': 'EC', 'LastName': 'Voldal', 'Affiliation': 'Department of Biostatistics, University of Washington, Box 357232, Seattle, WA 98195, United States. Electronic address: voldal@uw.edu.'}, {'ForeName': 'Navneet R', 'Initials': 'NR', 'LastName': 'Hakhu', 'Affiliation': 'Department of Statistics, University of California, Irvine, Irvine, CA 92697, United States.'}, {'ForeName': 'Fan', 'Initials': 'F', 'LastName': 'Xia', 'Affiliation': 'Department of Biostatistics, University of Washington, Box 357232, Seattle, WA 98195, United States.'}, {'ForeName': 'Patrick J', 'Initials': 'PJ', 'LastName': 'Heagerty', 'Affiliation': 'Department of Biostatistics, University of Washington, Box 357232, Seattle, WA 98195, United States.'}, {'ForeName': 'James P', 'Initials': 'JP', 'LastName': 'Hughes', 'Affiliation': 'Department of Biostatistics, University of Washington, Box 357232, Seattle, WA 98195, United States.'}]",Computer methods and programs in biomedicine,['10.1016/j.cmpb.2020.105514'] 1828,32554911,Effect of photobiomodulation on pain perception among orthodontic patients: a randomized clinical trial.,,2020,,['orthodontic patients'],['photobiomodulation'],['pain perception'],"[{'cui': 'C0332276', 'cui_str': 'Orthodontic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",[],"[{'cui': 'C3714605', 'cui_str': 'Pain sensation, function'}]",,0.215888,,"[{'ForeName': 'Nour', 'Initials': 'N', 'LastName': 'Al-Okla', 'Affiliation': 'Private Practice of Orthodontics in Dubai, United Arab Emarites.'}, {'ForeName': 'Dana', 'Initials': 'D', 'LastName': 'Bader', 'Affiliation': 'Private Practice of Orthodontics in Riyadh, Saudi Arabia.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Al-Mulla', 'Affiliation': 'Orthodontic Consultant, Riyadh, Saudi Arabia.'}, {'ForeName': 'Donald', 'Initials': 'D', 'LastName': 'Ferguson', 'Affiliation': 'European University College, Dubai, United Arab Emirates.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Shaughnessy', 'Affiliation': 'Private Practice of Orthodontics, Marietta, GA. str8tth@me.com.'}]",Journal of clinical orthodontics : JCO,[] 1829,32555432,Touching the social robot PARO reduces pain perception and salivary oxytocin levels.,"Human-human social touch improves mood and alleviates pain. No studies have so far tested the effect of human-robot emotional touch on experimentally induced pain ratings, on mood and on oxytocin levels in healthy young adults. Here, we assessed the effect of touching the robot PARO on pain perception, on mood and on salivary oxytocin levels, in 83 young adults. We measured their perceived pain, happiness state, and salivary oxytocin. For the 63 participants in the PARO group, pain was assessed in three conditions: Baseline, Touch (touching PARO) and No-Touch (PARO present). The control group (20 participants) underwent the same measurements without ever encountering PARO. There was a decrease in pain ratings and in oxytocin levels and an increase in happiness ratings compared to baseline only in the PARO group. The Touch condition yielded a larger decrease in pain ratings compared to No-Touch. These effects correlated with the participants' positive perceptions of the interaction with PARO. Participants with higher perceived ability to communicate with PARO experienced a greater hypoalgesic effect when touching PARO. We show that human-robot social touch is effective in reducing pain ratings, improving mood and - surprisingly - reducing salivary oxytocin levels in adults.",2020,There was a decrease in pain ratings and in oxytocin levels and an increase in happiness ratings compared to baseline only in the PARO group.,"['63 participants in the PARO group', 'adults', '83 young adults', 'healthy young adults']",['Human-human social touch'],"['salivary oxytocin levels', 'pain ratings and in oxytocin levels', 'mood and alleviates pain', 'perceived pain, happiness state, and salivary oxytocin', 'pain perception, on mood and on salivary oxytocin levels', 'pain', 'happiness ratings', 'pain ratings', 'pain perception and salivary oxytocin levels']","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0152054', 'cui_str': 'Touch'}]","[{'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0018592', 'cui_str': 'Cheerful mood'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C3714605', 'cui_str': 'Pain sensation, function'}]",83.0,0.0710033,There was a decrease in pain ratings and in oxytocin levels and an increase in happiness ratings compared to baseline only in the PARO group.,"[{'ForeName': 'Nirit', 'Initials': 'N', 'LastName': 'Geva', 'Affiliation': 'Recanati School for Community Health Professions, Department of Physical Therapy, Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel.'}, {'ForeName': 'Florina', 'Initials': 'F', 'LastName': 'Uzefovsky', 'Affiliation': 'Zlotowski Center for Neuroscience, Ben-Gurion University of the Negev, Beer-Sheva, Israel.'}, {'ForeName': 'Shelly', 'Initials': 'S', 'LastName': 'Levy-Tzedek', 'Affiliation': 'Recanati School for Community Health Professions, Department of Physical Therapy, Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel. shelly@bgu.ac.il.'}]",Scientific reports,['10.1038/s41598-020-66982-y'] 1830,32559463,Dynamic trial fitting by an expanding trial cup does not jeopardize primary acetabular component stability.,"BACKGROUND Trial fitting of the acetabular component in uncemented total hip replacement is traditionally done by trial cups. Since trial cups do not resemble the real press-fit obtained by the definitive cup, a dynamic trial inserter, called the X-pander ®, was developed to mimic the real amount of press-fit. However, the concern is raised of losing the initial press-fit by using the X-pander® due to pre-expansion of the acetabulum. The purpose of this study was to assess if there is a difference in primary stability between both methods. METHODS A biomechanical randomized study was performed with bovine calf acetabula, with randomization between either using the X-pander® or the traditional trial cups to assess primary stability. The primary outcome was the force needed to achieve lever out of the implanted cup (Anexys, Mathys or Trident, Stryker), measured in Newton meter (Nm) with a biomechanical testing set up. FINDINGS In total, 54 cups (19 Anexys, 35 Trident) were inserted and tested after randomized trial fitting. Overall mean lever out was 45.1 Nm (SD 14.6) for the X-pander® group and 45.0 Nm (SD 14.5) for the trial cups group. After adjustment for potential confounders (cup size and type) mixed model analysis did not reveal a significant difference in lever out force between both testing devices (mean 1.0 Nm, 95%CI (-5.9; 8.0), p = .77). INTERPRATION Initial press-fit of the implanted cup is not lost by pre-expansion as done with dynamic trial fitting with the X-pander®.",2020,"After adjustment for potential confounders (cup size and type) mixed model analysis did not reveal a significant difference in lever out force between both testing devices (mean 1.0 Nm, 95%CI (-5.9; 8.0), p = .77). ",[],"['INTERPRATION', 'bovine calf acetabula']","['force needed to achieve lever out of the implanted cup (Anexys, Mathys or Trident, Stryker), measured in Newton meter (Nm) with a biomechanical testing set up']",[],"[{'cui': 'C0007452', 'cui_str': 'Cattle'}, {'cui': 'C0230445', 'cui_str': 'Structure of calf of leg'}, {'cui': 'C0000962', 'cui_str': 'Bone structure of acetabulum'}]","[{'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0220647', 'cui_str': 'Carcinoma of unknown primary'}, {'cui': 'C1430904', 'cui_str': 'FOXM1 protein, human'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0542569', 'cui_str': 'newton'}, {'cui': 'C0441074', 'cui_str': 'Meters'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}]",54.0,0.260371,"After adjustment for potential confounders (cup size and type) mixed model analysis did not reveal a significant difference in lever out force between both testing devices (mean 1.0 Nm, 95%CI (-5.9; 8.0), p = .77). ","[{'ForeName': 'D', 'Initials': 'D', 'LastName': 'Hoornenborg', 'Affiliation': 'Xpert Orthopedie Amsterdam/SCORE (Specialized Center of Orthopedic Research and Education), Laarderhoogtweg 12, 1101EA Amsterdam, the Netherlands. Electronic address: d.hoornenborg@xpertorthopedie.nl.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'van Loon', 'Affiliation': 'Xpert Orthopedie Amsterdam/SCORE (Specialized Center of Orthopedic Research and Education), Laarderhoogtweg 12, 1101EA Amsterdam, the Netherlands; Academic Medical Center Amsterdam, Department of Orthopedic Surgery, Meibergdreef 15, 1105 AZ Amsterdam, the Netherlands. Electronic address: justin.vanloon@amc.uva.nl.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'de Waard', 'Affiliation': 'Xpert Orthopedie Amsterdam/SCORE (Specialized Center of Orthopedic Research and Education), Laarderhoogtweg 12, 1101EA Amsterdam, the Netherlands.'}, {'ForeName': 'I N', 'Initials': 'IN', 'LastName': 'Sierevelt', 'Affiliation': 'Xpert Orthopedie Amsterdam/SCORE (Specialized Center of Orthopedic Research and Education), Laarderhoogtweg 12, 1101EA Amsterdam, the Netherlands. Electronic address: i.n.sierevelt@score-amsterdam.nl.'}, {'ForeName': 'K T M', 'Initials': 'KTM', 'LastName': 'Opdam', 'Affiliation': 'Academic Medical Center Amsterdam, Department of Orthopedic Surgery, Meibergdreef 15, 1105 AZ Amsterdam, the Netherlands. Electronic address: k.t.opdam@amc.uva.nl.'}, {'ForeName': 'G M M J', 'Initials': 'GMMJ', 'LastName': 'Kerkhoffs', 'Affiliation': 'Academic Medical Center Amsterdam, Department of Orthopedic Surgery, Meibergdreef 15, 1105 AZ Amsterdam, the Netherlands. Electronic address: g.m.kerkhoffs@amc.uva.nl.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Haverkamp', 'Affiliation': 'Xpert Orthopedie Amsterdam/SCORE (Specialized Center of Orthopedic Research and Education), Laarderhoogtweg 12, 1101EA Amsterdam, the Netherlands. Electronic address: d.haverkamp@xpertorthopedie.nl.'}]","Clinical biomechanics (Bristol, Avon)",['10.1016/j.clinbiomech.2020.105077'] 1831,32559474,"Effects of the SGLT2 inhibitor dapagliflozin on proteinuria in non-diabetic patients with chronic kidney disease (DIAMOND): a randomised, double-blind, crossover trial.","BACKGROUND SGLT2 inhibition decreases albuminuria and reduces the risk of kidney disease progression in patients with type 2 diabetes. These benefits are unlikely to be mediated by improvements in glycaemic control alone. Therefore, we aimed to examine the kidney effects of the SGLT2 inhibitor dapagliflozin in patients with proteinuric kidney disease without diabetes. METHODS DIAMOND was a randomised, double-blind, placebo-controlled crossover trial done at six hospitals in Canada, Malaysia, and the Netherlands. Eligible participants were adult patients (aged 18-75 years) with chronic kidney disease, without a diagnosis of diabetes, with a 24-h urinary protein excretion greater than 500 mg and less than or equal to 3500 mg and an estimated glomerular filtration rate (eGFR) of at least 25 mL/min per 1·73 m 2 , and who were on stable renin-angiotensin system blockade. Participants were randomly assigned (1:1) to receive placebo and then dapagliflozin 10 mg per day or vice versa. Each treatment period lasted 6 weeks with a 6-week washout period in between. Participants, investigators, and study personnel were masked to assignment throughout the trial and analysis. The primary outcome was percentage change from baseline in 24-h proteinuria during dapagliflozin treatment relative to placebo. Secondary outcomes were changes in measured GFR (mGFR; via iohexol clearance), bodyweight, blood pressure, and concentrations of neurohormonal biomarkers. Analyses were done in accordance with the intention-to-treat principle. This study is registered with ClinicalTrials.gov, NCT03190694. FINDINGS Between Nov 22, 2017, and April 5, 2019, 58 patients were screened, of whom 53 (mean age 51 years [SD 13]; 32% women) were randomly assigned (27 received dapagliflozin then placebo and 26 received placebo then dapagliflozin). One patient discontinued during the first treatment period. All patients were included in the analysis. Mean baseline mGFR was 58·3 mL/min per 1·73 m 2 (SD 23), median proteinuria was 1110 mg per 24 h (IQR 730-1560), and mean HbA 1c was 5·6% (SD 0·4). The difference in mean proteinuria change from baseline between dapagliflozin and placebo was 0·9% (95% CI -16·6 to 22·1; p=0·93). Compared with placebo, mGFR was changed with dapagliflozin treatment by -6·6 mL/min per 1·73 m 2 (-9·0 to -4·2; p<0·0001) at week 6. This reduction was fully reversible within 6 weeks after dapagliflozin discontinuation. Compared with placebo, bodyweight was reduced by 1·5 kg (0·03-3·0; p=0·046) with dapagliflozin; changes in systolic and diastolic blood pressure and concentrations of neurohormonal biomarkers did not differ significantly between dapagliflozin and placebo treatment. The numbers of patients who had one or more adverse events during dapagliflozin treatment (17 [32%] of 53) and during placebo treatment (13 [25%] of 52) were similar. No hypoglycaemic events were reported and no deaths occurred. INTERPRETATION 6-week treatment with dapagliflozin did not affect proteinuria in patients with chronic kidney disease without diabetes, but did induce an acute and reversible decline in mGFR and a reduction in bodyweight. Long-term clinical trials are underway to determine whether SGLT2 inhibitors can safely reduce the rate of major clinical kidney outcomes in patients with chronic kidney disease with and without diabetes. FUNDING AstraZeneca.",2020,"Compared with placebo, mGFR was changed with dapagliflozin treatment by -6·6 mL/min per 1·73 m 2 (-9·0 to -4·2; p<0·0001) at week 6.","['Eligible participants were adult patients (aged 18-75 years) with chronic kidney disease, without a diagnosis of diabetes, with a 24-h urinary protein excretion greater than 500 mg and less than or equal to 3500 mg and an estimated glomerular filtration rate (eGFR) of at least 25 mL/min per 1·73 m 2 , and who were on stable renin-angiotensin system blockade', '58 patients were screened, of whom 53 (mean age 51 years [SD 13]; 32% women', 'patients with chronic kidney disease with and without diabetes', 'Between Nov 22, 2017, and April 5, 2019', 'patients with proteinuric kidney disease without diabetes', 'patients with type 2 diabetes', 'non-diabetic patients with chronic kidney disease (DIAMOND', 'patients with chronic kidney disease without diabetes', 'six hospitals in Canada, Malaysia, and the Netherlands']","['dapagliflozin then placebo', 'dapagliflozin', 'SGLT2 inhibitors', 'placebo and then dapagliflozin 10 mg per day or vice versa', 'SGLT2 inhibitor dapagliflozin', 'placebo then dapagliflozin', 'dapagliflozin and placebo', 'placebo']","['systolic and diastolic blood pressure and concentrations of neurohormonal biomarkers', 'median proteinuria', 'percentage change from baseline in 24-h proteinuria', 'mean proteinuria change', 'adverse events', 'hypoglycaemic events', 'changes in measured GFR (mGFR; via iohexol clearance), bodyweight, blood pressure, and concentrations of neurohormonal biomarkers', 'Mean baseline mGFR']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0439090', 'cui_str': '<='}, {'cui': 'C4517736', 'cui_str': '3500'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0439445', 'cui_str': 'mL/min'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0035094', 'cui_str': 'Renin'}, {'cui': 'C0003018', 'cui_str': 'Angiotensin'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0332206', 'cui_str': 'Blocking'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0949920', 'cui_str': 'Norovirus'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0022658', 'cui_str': 'Kidney disease'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0057717', 'cui_str': 'Diamond'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0024552', 'cui_str': 'Malaysia'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}]","[{'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3273807', 'cui_str': 'SGLT2 Inhibitors'}, {'cui': 'C3709918', 'cui_str': 'dapagliflozin 10 MG'}, {'cui': 'C0439505', 'cui_str': '/day'}]","[{'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0033687', 'cui_str': 'Proteinuria'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0020616', 'cui_str': 'Hypoglycemic agent'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0022005', 'cui_str': 'Iohexol'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}]",58.0,0.624837,"Compared with placebo, mGFR was changed with dapagliflozin treatment by -6·6 mL/min per 1·73 m 2 (-9·0 to -4·2; p<0·0001) at week 6.","[{'ForeName': 'David Z I', 'Initials': 'DZI', 'LastName': 'Cherney', 'Affiliation': 'Division of Nephrology, Department of Medicine, University Health Network and University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Claire C J', 'Initials': 'CCJ', 'LastName': 'Dekkers', 'Affiliation': 'Department of Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Centre Groningen, Groningen, Netherlands.'}, {'ForeName': 'Sean J', 'Initials': 'SJ', 'LastName': 'Barbour', 'Affiliation': 'Division of Nephrology, Department of Medicine, University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Cattran', 'Affiliation': 'Division of Nephrology, Department of Medicine, University Health Network and University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Abdul Halim', 'Initials': 'AH', 'LastName': 'Abdul Gafor', 'Affiliation': 'Department of Medicine, Hospital Canselor Tuanku Muhriz, Universiti Kebangsaan Malaysia Medical Centre, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Greasley', 'Affiliation': 'Early Clinical Development, Research and Early Development, Cardiovascular, Renal and Metabolism (CVRM), BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Gozewijn D', 'Initials': 'GD', 'LastName': 'Laverman', 'Affiliation': 'Department of Internal Medicine, ZGT Hospital, Almelo and Hengelo, Netherlands.'}, {'ForeName': 'Soo Kun', 'Initials': 'SK', 'LastName': 'Lim', 'Affiliation': 'Division of Nephrology, Department of Medicine, University of Malaya, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Gian Luca', 'Initials': 'GL', 'LastName': 'Di Tanna', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Sydney, NSW, Australia.'}, {'ForeName': 'Heather N', 'Initials': 'HN', 'LastName': 'Reich', 'Affiliation': 'Division of Nephrology, Department of Medicine, University Health Network and University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Marc G', 'Initials': 'MG', 'LastName': 'Vervloet', 'Affiliation': 'Department of Nephrology and Amsterdam Cardiovascular Sciences, Amsterdam University Medical Center, Amsterdam, Netherlands.'}, {'ForeName': 'Muh Geot', 'Initials': 'MG', 'LastName': 'Wong', 'Affiliation': 'The George Institute for Global Health, University of New South Wales, Sydney, NSW, Australia; Royal North Shore Hospital, St Leonards, NSW, Australia.'}, {'ForeName': 'Ron T', 'Initials': 'RT', 'LastName': 'Gansevoort', 'Affiliation': 'Department of Nephrology, University of Groningen, University Medical Centre Groningen, Groningen, Netherlands.'}, {'ForeName': 'Hiddo J L', 'Initials': 'HJL', 'LastName': 'Heerspink', 'Affiliation': 'Department of Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Centre Groningen, Groningen, Netherlands. Electronic address: h.j.lambers.heerspink@umcg.nl.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The lancet. Diabetes & endocrinology,['10.1016/S2213-8587(20)30162-5'] 1832,32559515,Fampridine-induced changes in walking kinetics are associated with clinical improvements in patients with multiple sclerosis.,"Gait dysfunction is common in patients with multiple sclerosis (PwMS). Treatment with prolonged-release fampridine (PR-fampridine) improves walking ability in some PwMS. Associated fampridine-induced changes in the walking pattern are still poorly understood but may provide a better understanding of the mechanisms underlying the beneficial drug effects. 61 PwMS were treated with PR-fampridine in a randomized, monocentric, double-blind and placebo-controlled clinical trial with crossover design (FAMPKIN). Drug-induced improvements in walking speed (Timed-25-Foot Walk; T25FW) and endurance (6-Minute Walk Test; 6MWT) were quantified. In this sub-study of the FAMPKIN trial, fampridine-induced changes in kinetic gait patterns were analyzed by pressure-based foot print analysis during treadmill walking. Vertical ground reaction forces were analyzed during different gait phases. Kinetic data of 44 PwMS was eligible for analysis. During double-blind treatment with PR-fampridine, patients performed significantly better in the T25FW and 6MWT than during placebo treatment (p < 0.0001 for both). At the group level (n = 44), there were no significant changes of gait kinetics under PR-fampridine vs. placebo. However, we found relevant changes of walking kinetics regarding forces during loading, single limb and pre-swing phase in a patient sub-group (n = 8). Interestingly, this sub-group demonstrated superior responsiveness to PR-fampridine in the clinical walking tests compared to those patients without any fampridine-induced changes in kinetics (n = 36). Our results demonstrate fampridine-induced changes in gait kinetics in a sub-group of PwMS. These gait pattern changes were accompanied by improved clinical walking performance under PR-fampridine. These results shed some light on the biomechanical changes in walking patterns underlying enhanced fampridine-induced gait performance.",2020,"At the group level (n = 44), there were no significant changes of gait kinetics under PR-fampridine vs. placebo.","['patients with multiple sclerosis', 'patients with multiple sclerosis (PwMS']","['PR-fampridine', 'prolonged-release fampridine (PR-fampridine', 'placebo']","['clinical walking performance', 'Vertical ground reaction forces', 'walking kinetics', 'gait kinetics', 'Gait dysfunction', 'walking speed (Timed-25-Foot Walk; T25FW) and endurance (6-Minute Walk Test; 6MWT', 'kinetic gait patterns', 'T25FW and 6MWT']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}]","[{'cui': 'C0000477', 'cui_str': 'dalfampridine'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0022702', 'cui_str': 'Kinetics'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0430515', 'cui_str': '6-minute walk test'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}]",61.0,0.124543,"At the group level (n = 44), there were no significant changes of gait kinetics under PR-fampridine vs. placebo.","[{'ForeName': 'D', 'Initials': 'D', 'LastName': 'Weller', 'Affiliation': 'Department of Neurology, University Hospital and University of Zurich, Frauenklinikstrasse 26, 8091 Zurich, Switzerland.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Lörincz', 'Affiliation': 'Department of Neurology, University Hospital and University of Zurich, Frauenklinikstrasse 26, 8091 Zurich, Switzerland.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Sutter', 'Affiliation': 'Department of Neurology, University Hospital and University of Zurich, Frauenklinikstrasse 26, 8091 Zurich, Switzerland.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Reuter', 'Affiliation': 'Department of Neurology, University Hospital and University of Zurich, Frauenklinikstrasse 26, 8091 Zurich, Switzerland.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Linnebank', 'Affiliation': 'Department of Neurology, University Witten/Herdecke and Evangelische Kliniken Gelsenkirchen, Munckelstraße 32, 45879 Gelsenkirchen, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Weller', 'Affiliation': 'Department of Neurology, University Hospital and University of Zurich, Frauenklinikstrasse 26, 8091 Zurich, Switzerland.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Zörner', 'Affiliation': 'Spinal Cord Injury Center, Balgrist University Hospital, Forchstrasse 340, 8008 Zurich, Switzerland.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Filli', 'Affiliation': 'Department of Neurology, University Hospital and University of Zurich, Frauenklinikstrasse 26, 8091 Zurich, Switzerland; Spinal Cord Injury Center, Balgrist University Hospital, Forchstrasse 340, 8008 Zurich, Switzerland; Swiss Center for clinical Movement Analysis (SCMA), Balgrist Campus AG, Lengghalde 5, 8008 Zurich, Switzerland. Electronic address: linard.filli@balgrist.ch.'}]",Journal of the neurological sciences,['10.1016/j.jns.2020.116978'] 1833,32559601,Cardiovascular responses to pelvic floor muscle contraction in healthy women: Prospective study.,"OBJECTIVE Analyze the acute heart rate and blood pressure responses to two protocols of pelvic floor muscles contractions in premenopausal and postmenopausal women. METHODS Fifty-four women without pelvic floor muscles disorders were eligible and allocated into two groups: premenopausal and postmenopausal. The groups underwent two protocols and the pelvic floor muscle endurance, heart rate, and blood pressure values were monitored. Both protocols included 10 pelvic floor muscles contractions; one series contained contractions lasting 5 s with 5 s of rest between each contraction and the other series contained contractions lasting 10 s with 10 s of rest. RESULTS In both groups, there was a significant increase in the heart rate during pelvic floor muscles contractions (premenopausal: 71.0 ± 7.3 and 80.3 ± 7.7; postmenopausal: 65.4 ± 6.6 and 73.6 ± 6.6, at rest and contractions peak, respectively) and in systolic blood pressure immediately after the contractions. The observed values during exercise returned to basal values seconds after the contractions. A positive correlation between heart rate and vaginal squeeze pressure (r = 0.45, p = 0.0007 and r = 0.48, p = 0.0003, 5- and 10-s series, respectively) was observed. CONCLUSION The proposed protocol of isometric pelvic floor muscles contractions caused an increase in heart rate and blood pressure within the normal range and might not represent a cardiovascular risk for healthy postmenopausal women without urinary incontinence and without cardiovascular dysfunctions.",2020,The proposed protocol of isometric pelvic floor muscles contractions caused an increase in heart rate and blood pressure within the normal range and might not represent a cardiovascular risk for healthy postmenopausal women without urinary incontinence and without cardiovascular dysfunctions.,"['premenopausal and postmenopausal women', 'healthy women', 'healthy postmenopausal women without urinary incontinence and without cardiovascular dysfunctions', 'Fifty-four women without pelvic floor muscles disorders were eligible and allocated into two groups: premenopausal and postmenopausal']",['pelvic floor muscles contractions'],"['heart rate and blood pressure', 'pelvic floor muscle endurance, heart rate, and blood pressure values', 'heart rate', 'Cardiovascular responses', 'systolic blood pressure', 'heart rate and vaginal squeeze pressure']","[{'cui': 'C1096235', 'cui_str': 'Premenopausal symptoms'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0042024', 'cui_str': 'Urinary incontinence'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C4517807', 'cui_str': '54'}, {'cui': 'C0206248', 'cui_str': 'Pelvic floor structure'}, {'cui': 'C0026848', 'cui_str': 'Disorder of muscle'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0206248', 'cui_str': 'Pelvic floor structure'}, {'cui': 'C0026820', 'cui_str': 'Muscle contraction'}]","[{'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0206248', 'cui_str': 'Pelvic floor structure'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0413258', 'cui_str': 'Barotrauma of descent'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}]",54.0,0.0281104,The proposed protocol of isometric pelvic floor muscles contractions caused an increase in heart rate and blood pressure within the normal range and might not represent a cardiovascular risk for healthy postmenopausal women without urinary incontinence and without cardiovascular dysfunctions.,"[{'ForeName': 'Alana Maria G', 'Initials': 'AMG', 'LastName': 'Bastos', 'Affiliation': ""Women's Health Research Laboratory, Physical Therapy Department, Federal University of São Carlos, São Carlos, São Paulo State, Brazil.""}, {'ForeName': 'Aparecida M', 'Initials': 'AM', 'LastName': 'Catai', 'Affiliation': 'Cardiovascular Physical Therapy Laboratory, Physical Therapy Department, Federal University of São Carlos, São Carlos, São Paulo State, Brazil.'}, {'ForeName': 'Soraia P', 'Initials': 'SP', 'LastName': 'Jürgensen', 'Affiliation': ""Women's Health Research Laboratory, Physical Therapy Department, Federal University of São Carlos, São Carlos, São Paulo State, Brazil.""}, {'ForeName': 'Grasiela N', 'Initials': 'GN', 'LastName': 'Correia', 'Affiliation': ""Women's Health Research Laboratory, Physical Therapy Department, Federal University of São Carlos, São Carlos, São Paulo State, Brazil.""}, {'ForeName': 'Vanessa S', 'Initials': 'VS', 'LastName': 'Pereira-Baldon', 'Affiliation': ""Women's Health Research Laboratory, Physical Therapy Department, Federal University of São Carlos, São Carlos, São Paulo State, Brazil.""}, {'ForeName': 'Natalia', 'Initials': 'N', 'LastName': 'Perseguini', 'Affiliation': 'Cardiovascular Physical Therapy Laboratory, Physical Therapy Department, Federal University of São Carlos, São Carlos, São Paulo State, Brazil.'}, {'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'Borghi-Silva', 'Affiliation': 'Cardiovascular Physical Therapy Laboratory, Physical Therapy Department, Federal University of São Carlos, São Carlos, São Paulo State, Brazil.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Driusso', 'Affiliation': ""Women's Health Research Laboratory, Physical Therapy Department, Federal University of São Carlos, São Carlos, São Paulo State, Brazil. Electronic address: pdriusso@ufscar.br.""}]","European journal of obstetrics, gynecology, and reproductive biology",['10.1016/j.ejogrb.2020.05.050'] 1834,32561466,A randomized clinical trial of a collaborative home-based diabetes intervention to reduce emergency department visits and hospitalizations in black individuals with diabetes.,"The prevalence of diabetes mellitus (DM) in black individuals (blacks) is twice that of white individuals (whites), and blacks are more likely to have worse glycemic control, less optimal medication regimens, and higher levels of mistrust in the medical system. These three factors account for higher rates of acute medical care use in blacks with DM. To address this disparity, we developed DM I-TEAM (Diabetes Interprofessional Team to Enhance Adherence to Medical Care), a home-based multidisciplinary behavioral intervention that integrates care from a community health worker (CHW), the participant's primary care physician (PCP), a DM nurse educator, and a clinical pharmacist. Treatment is delivered during 9 sessions over 1 year, and includes diabetes education and goal setting, telehealth visits with participants' PCP and a DM nurse educator, and comprehensive medication reviews by a pharmacist. We describe the rationale and methods for a randomized controlled trial to test the efficacy of DM I-TEAM to reduce emergency department (ED) visits and hospitalizations. We are enrolling 200 blacks with DM during an ED visit. Participants are randomized to DM I-TEAM or Usual Medical Care (UMC). Follow-up assessments are conducted at 6 and 12 months. The primary outcome is the number of ED visits and hospitalizations over 12 months, and is measured by participant self-report and medical record review. Secondary outcomes include hemoglobin A1c (HbA1c), number of potentially inappropriate medications (PIMs), and trust in health care.",2020,"The prevalence of diabetes mellitus (DM) in black individuals (blacks) is twice that of white individuals (whites), and blacks are more likely to have worse glycemic control, less optimal medication regimens, and higher levels of mistrust in the medical system.","['200 blacks with DM during an ED visit', 'blacks with DM', 'black individuals (blacks', 'black individuals with diabetes']","['DM I-TEAM', 'collaborative home-based diabetes intervention', 'DM I-TEAM or Usual Medical Care (UMC']","['hemoglobin A1c (HbA1c), number of potentially inappropriate medications (PIMs), and trust in health care', 'emergency department (ED) visits and hospitalizations', 'prevalence of diabetes mellitus (DM', 'number of ED visits and hospitalizations over 12\u202fmonths, and is measured by participant self-report and medical record review']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0586082', 'cui_str': 'Emergency department patient visit'}]","[{'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0496675', 'cui_str': 'Medical care'}]","[{'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C4042848', 'cui_str': 'PIM List'}, {'cui': 'C0237935', 'cui_str': 'Trust'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0586082', 'cui_str': 'Emergency department patient visit'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0730229', 'cui_str': 'Medical records review'}]",200.0,0.0803291,"The prevalence of diabetes mellitus (DM) in black individuals (blacks) is twice that of white individuals (whites), and blacks are more likely to have worse glycemic control, less optimal medication regimens, and higher levels of mistrust in the medical system.","[{'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Casten', 'Affiliation': 'Department of Psychiatry and Human Behavior, Sidney Kimmel Medical College at Thomas, Jefferson University, United States of America. Electronic address: Robin.Casten@Jefferson.edu.'}, {'ForeName': 'Barry', 'Initials': 'B', 'LastName': 'Rovner', 'Affiliation': 'Departments of Neurology, Psychiatry, and Ophthalmology, Sidney Kimmel Medical College at Thomas Jefferson University, United States of America.'}, {'ForeName': 'Anna Marie', 'Initials': 'AM', 'LastName': 'Chang', 'Affiliation': 'Department of Emergency Medicine, Sidney Kimmel Medical College at Thomas Jefferson University, United States of America.'}, {'ForeName': 'Judd E', 'Initials': 'JE', 'LastName': 'Hollander', 'Affiliation': 'Department of Emergency Medicine, Sidney Kimmel Medical College at Thomas Jefferson University, United States of America.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Kelley', 'Affiliation': 'Department of Neurology, Sidney Kimmel Medical College at Thomas Jefferson University, United States of America.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Leiby', 'Affiliation': 'Division of Biostatistics, Department of Pharmacology and Experimental Therapeutics, Sidney Kimmel Medical College at Thomas Jefferson University, United States of America.'}, {'ForeName': 'Ginah', 'Initials': 'G', 'LastName': 'Nightingale', 'Affiliation': 'Jefferson College of Pharmacy at Thomas Jefferson University, United States of America.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Pizzi', 'Affiliation': 'Center for Health Outcomes, Policy, and Economics, Ernest Mario School of Pharmacy, Rutgers University, United States of America.'}, {'ForeName': 'Neva', 'Initials': 'N', 'LastName': 'White', 'Affiliation': 'Center for Urban Health, Thomas Jefferson University Hospital, United States of America.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Rising', 'Affiliation': 'Department of Emergency Medicine, Sidney Kimmel Medical College at Thomas Jefferson University, United States of America.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106069'] 1835,32561467,A randomized comparison trial of culturally adapted HIV prevention approaches for Native Americans reducing trauma symptoms versus substance misuse: The Healing Seasons protocol.,"Native Americans (NA) experience interrelated risks of trauma exposure, substance use, and HIV risk behaviors that put them at increased risk for HIV infection. Despite these known risk factors, there are very few published randomized trials testing interventions to reduce trauma-related symptoms and substance misuse among NA. METHODS The Healing Seasons study is a randomized comparsion trial of two counseling strategies, Narrative Exposure Therapy (NET) addressing PTSD or Motivational interviewing with cognitive behavioral therapy skills training (MIST) addressing substance misuse as a means to prevent HIV among NA. Using a community-based participatory research approach, we adapted both evidence-based interventions to be specific to the risk contexts and realities of NA and to include psychoeducational and skill-building components that include cultural-specific stories, virtues, and traditional treatment strategies. Participants, 16 years and older, were recruited from a Pacific Northwest tribal community, screened over the phone, enrolled in person, and randomized in equal numbers to NET or MIST. We stratified by age (16-29 years and 30 or older) and gender (male or female identified) to ensure balance between treatment arms. The primary outcomes were number of sex partners and frequency of sexual acts (with and without condoms), sex under the influence of substances, frequency of substance use, and PTSD severity. DISCUSSION Behavioral interventions for NA are needed to prevent HIV risk behaviors when faced with trauma symptoms and substance misuse. This study will provide evidence to determine feasibility and efficacy of addressing related risk factors as part of counseling-based HIV prevention intervention to reduce sexual risk among this population. TRIAL REGISTRATION ClinicalTrials.gov number, NCT03112369, registered April 12, 2017.",2020,"Using a community-based participatory research approach, we adapted both evidence-based interventions to be specific to the risk contexts and realities of NA and to include psychoeducational and skill-building components that include cultural-specific stories, virtues, and traditional treatment strategies.","['Native Americans reducing trauma symptoms versus substance misuse', 'We stratified by age (16-29\u202fyears and 30 or older) and gender (male or female identified', 'Participants, 16\u202fyears and older, were recruited from a Pacific Northwest tribal community, screened over the phone, enrolled in person']","['NET or MIST', 'culturally adapted HIV prevention approaches', 'Narrative Exposure Therapy (NET) addressing PTSD or Motivational interviewing with cognitive behavioral therapy skills training (MIST', 'counseling-based HIV prevention intervention']","['number of sex partners and frequency of sexual acts (with and without condoms), sex under the influence of substances, frequency of substance use, and PTSD severity', 'HIV risk behaviors']","[{'cui': 'C0282204', 'cui_str': 'Native Americans'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0439861', 'cui_str': 'Substance'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030170', 'cui_str': 'Pacific Northwest'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C1135957', 'cui_str': 'Narration'}, {'cui': 'C0870527', 'cui_str': 'Exposure Therapy'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0559197', 'cui_str': 'Skills training'}, {'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0376649', 'cui_str': 'Addresses'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0036911', 'cui_str': 'Sexual partners'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0439861', 'cui_str': 'Substance'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0086931', 'cui_str': 'Risk Behavior'}]",,0.0757073,"Using a community-based participatory research approach, we adapted both evidence-based interventions to be specific to the risk contexts and realities of NA and to include psychoeducational and skill-building components that include cultural-specific stories, virtues, and traditional treatment strategies.","[{'ForeName': 'C R', 'Initials': 'CR', 'LastName': 'Pearson', 'Affiliation': 'Indigenous Wellness Research Institute, School of Social Work, University of Washington, Seattle, WA, USA. Electronic address: pearsonc@uw.edu.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Kaysen', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Huh', 'Affiliation': 'Indigenous Wellness Research Institute, School of Social Work, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Bedard-Gillgan', 'Affiliation': 'Department of Psychiatry, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Walker', 'Affiliation': 'Innovative Programs Research Group, School of Social Work, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Marin', 'Affiliation': 'Indigenous Wellness Research Institute, School of Social Work, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Saluskin', 'Affiliation': 'Yakama Nation Behavioral Health Services, Toppenish, WA, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106070'] 1836,32576351,[Application of acute physiology and chronic health evaluation II score in the timing of noninvasive ventilation in patients with acute exacerbation of chronic obstructive pulmonary disease].,"OBJECTIVE To explore the application of acute physiology and chronic health evaluation II (APACHE II) score in the timing and nursing of noninvasive ventilation for patients with acute exacerbation of chronic obstructive pulmonary disease (AECOPD). METHODS 106 AECOPD patients admitted to Haikou People's Hospital from January 2018 to October 2019 were selected as the study objects. According to the method of random number table, the patients were divided into observation group and control group, with 53 patients in each group. The control group selected the timing of noninvasive ventilation treatment according to the standards of Mechanical ventilation (second edition), weaned according to Clinical practice of mechanical ventilation, and received routine nursing in intensive care unit (ICU), including creating comfortable indoor environment, reasonable diet, condition monitoring, psychological nursing and complications nursing. On the basis of the control group, the patients in the observation group were given noninvasive ventilation when APACHE II score was more than 10, and were weaned when APACHE II score was less than or equal to 10. According to APACHE II score < 10, 10-14, 15-19 and ≥ 20, the patients were given level-3 care, level-2 care, level-1 care and intensive care. The pulmonary function before and 3 days after the noninvasive ventilation treatment was monitored, and the duration of mechanical ventilation, the length of ICU stay, endotracheal intubation rate, incidence of complication [ventilator associated pneumonia (VAP)] and ICU mortality were recorded. The self-designed questionnaire of nursing satisfaction was used to evaluate the patients' nursing satisfaction. RESULTS There was no significant difference in general data such as gender or age between the two groups. After 3 days of noninvasive ventilation, the forced expiratory volume in one second (FEV1), forced vital capacity (FVC) and FEV1/FVC ratio of the two groups were increased significantly as compared with those before treatment, especially in the observation group, with statistical significances as compared with the control group [FEV1 (L): 3.02±0.22 vs. 2.54±0.19, FVC (L): 3.01±0.32 vs. 2.13±0.28, FEV1/FVC ratio: 0.89±0.08 vs. 0.79±0.08, all P < 0.05]. Compared with the control group, the duration of mechanical ventilation and length of ICU stay in the observation group were significantly shortened [duration of mechanical ventilation (days): 4.32±0.73 vs. 8.42±1.94, length of ICU stay (hours): 32.23±10.22 vs. 38.52±9.85, both P < 0.01]. The intubation rate, incidence of VAP and ICU mortality in the observation group were significantly lower than those in the control group [intubation rate: 1.9% (1/53) vs. 13.2% (7/53), incidence of VAP: 1.9% (1/53) vs. 15.1% (8/53), ICU mortality: 1.9% (1/53) vs. 13.2% (7/53), all P < 0.05]. The nursing satisfaction of patients in the observation group was significantly higher than that in the control group [96.2% (51/53) vs. 75.5% (40/53), P < 0.01]. CONCLUSIONS APACHE II score can be used to guide the choice of noninvasive ventilation treatment opportunity and nursing intervention measures for AECOPD patients. It can significantly improve the pulmonary function of patients, improve the treatment effect, reduce the incidence of complications, and improve the satisfaction of patients with nursing, which is effective in clinical application.",2020,"The intubation rate, incidence of VAP and ICU mortality in the observation group were significantly lower than those in the control group [intubation rate: 1.9% (1/53) vs. 13.2% (7/53), incidence of VAP: 1.9% (1/53) vs. 15.1% (8/53), ICU mortality: 1.9% (1/53) vs. 13.2% (7/53), all P < 0.05].","['patients with acute exacerbation of chronic obstructive pulmonary disease (AECOPD', 'AECOPD patients', ""106 AECOPD patients admitted to Haikou People's Hospital from January 2018 to October 2019 were selected as the study objects"", 'patients with acute exacerbation of chronic obstructive pulmonary disease']","['noninvasive ventilation', 'noninvasive ventilation treatment according to the standards of Mechanical ventilation (second edition), weaned according to Clinical practice of mechanical ventilation, and received routine nursing in intensive care unit (ICU), including creating comfortable indoor environment, reasonable diet, condition monitoring, psychological nursing and complications nursing']","['duration of mechanical ventilation, the length of ICU stay, endotracheal intubation rate, incidence of complication [ventilator associated pneumonia (VAP)] and ICU mortality', 'intubation rate, incidence of VAP and ICU mortality', 'forced expiratory volume in one second (FEV1), forced vital capacity (FVC) and FEV1/FVC ratio', 'nursing satisfaction', 'incidence of VAP', 'ICU mortality', 'pulmonary function', 'duration of mechanical ventilation and length of ICU stay']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0340044', 'cui_str': 'Acute exacerbation of chronic obstructive airways disease'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0347997', 'cui_str': 'Physical object'}]","[{'cui': 'C1997883', 'cui_str': 'Noninvasive ventilation'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0441795', 'cui_str': 'Second edition'}, {'cui': 'C0043084', 'cui_str': 'Weaning'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]","[{'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0021932', 'cui_str': 'Insertion of endotracheal tube'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0087153', 'cui_str': 'Ventilator'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0430511', 'cui_str': 'Vital capacity test'}, {'cui': 'C0042834', 'cui_str': 'Vital capacity'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0231921', 'cui_str': 'Pulmonary function'}]",106.0,0.0268742,"The intubation rate, incidence of VAP and ICU mortality in the observation group were significantly lower than those in the control group [intubation rate: 1.9% (1/53) vs. 13.2% (7/53), incidence of VAP: 1.9% (1/53) vs. 15.1% (8/53), ICU mortality: 1.9% (1/53) vs. 13.2% (7/53), all P < 0.05].","[{'ForeName': 'Jumei', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': ""Department of Respiratory and Critical Care Medicine, Central South University Xiangya School of Medicine Affiliated Haikou Hospital (Haikou People's Hospital), Haikou 570208, Hainan, China. Corresponding author: Zeng Cimei, Email: chenhushi980@126.com.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Wanrong', 'Initials': 'W', 'LastName': 'Qiu', 'Affiliation': ''}, {'ForeName': 'Qionge', 'Initials': 'Q', 'LastName': 'Fu', 'Affiliation': ''}, {'ForeName': 'Cimei', 'Initials': 'C', 'LastName': 'Zeng', 'Affiliation': ''}]",Zhonghua wei zhong bing ji jiu yi xue,['10.3760/cma.j.cn121430-20200106-00159'] 1837,32577921,Randomized comparative study of child and caregiver responses to three software functions added to the Japanese version of the electronic Pediatric Quality of Life Inventory (ePedsQL) questionnaire.,"BACKGROUND Patient-reported outcomes (PROs) refer to any report of the status of a patient's health condition, health behavior, or experience with healthcare directly from the patient, without interpretation of the patient's response by a clinician or any other external party. While many PROs, such as the Pediatric Quality of Life Inventory (PedsQL), were originally administered in paper-and-pencil format, these are now available as electronic versions (ePROs). Although ePROs might well have used the same structure as their paper versions, we developed an alternate ePedsQL incorporating three software functions: 1) a non-forcing non-response alert, 2) a conditional question branch of the School Functioning Scale that only displays for (pre) school children, and 3) a vertical item-by-item display for small-screen devices. This report evaluated the effect of these functions on item non-response rate, survey completion time, and user experience. METHODS All surveys were conducted via the online/computer mode. We compared the dynamic format containing the three functions with the basic format in a randomized comparative study in 2803 children and 6289 caregivers in Japan. RESULTS We found that the non-response alert lowered the item non-response rate (0.338% to 0.046%, t = - 4.411, p < 0.001 by generalized linear mixed model analysis). The conditional question branch had mixed effects on survey completion time depending on the respondents' age. Surprisingly, respondents rated the vertical question display for handheld devices less legible than the matrix format. Further, multigroup structural equation modelling revealed that the same configuration for both formats showed an acceptable fit (CFI 0.933, RMSEA 0.060, SRMR 0.038) but the errors of observed variables were larger for the dynamic format than the basic format. CONCLUSIONS We confirmed the robustness of the ePedsQL in different formats. The non-response rate of ePedsQL was very low even in the absence of an alert. The branch and item-by-item display were effective but unnecessary for all populations. Our findings further understanding of how humans respond to special software functions and different digital survey formats and provide new insight on how the three tested functions might be most successfully implemented.",2020,"We found that the non-response alert lowered the item non-response rate (0.338% to 0.046%, t = - 4.411, p < 0.001 by generalized linear mixed model analysis).",['2803 children and 6289 caregivers in Japan'],[],"['survey completion time', 'item non-response rate', 'item non-response rate, survey completion time, and user experience', 'electronic Pediatric Quality of Life Inventory (ePedsQL) questionnaire']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0022341', 'cui_str': 'Japan'}]",[],"[{'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",2803.0,0.0234042,"We found that the non-response alert lowered the item non-response rate (0.338% to 0.046%, t = - 4.411, p < 0.001 by generalized linear mixed model analysis).","[{'ForeName': 'Iori', 'Initials': 'I', 'LastName': 'Sato', 'Affiliation': 'Department of Family Nursing, Division of Health Sciences and Nursing, Graduate School of Medicine, the University of Tokyo, Tokyo, Japan. satoi-tky@umin.ac.jp.'}, {'ForeName': 'Mariko', 'Initials': 'M', 'LastName': 'Sakka', 'Affiliation': 'Department of Health Quality and Outcome Research, Division of Nursing System, Global Nursing Research Center, Graduate School of Medicine, the University of Tokyo, Hongo 7-3-1, Bunkyo-ku, Tokyo, 113-0033, Japan.'}, {'ForeName': 'Takafumi', 'Initials': 'T', 'LastName': 'Soejima', 'Affiliation': 'Department of Family Nursing, Division of Health Sciences and Nursing, Graduate School of Medicine, the University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Sachiko', 'Initials': 'S', 'LastName': 'Kita', 'Affiliation': 'Department of Family Nursing, Division of Health Sciences and Nursing, Graduate School of Medicine, the University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Kiyoko', 'Initials': 'K', 'LastName': 'Kamibeppu', 'Affiliation': 'Department of Family Nursing, Division of Health Sciences and Nursing, Graduate School of Medicine, the University of Tokyo, Tokyo, Japan.'}]",Journal of patient-reported outcomes,['10.1186/s41687-020-00213-w'] 1838,32129511,Safety and efficacy of self-administered romiplostim in patients with immune thrombocytopenia: Results of an integrated database of five clinical trials.,"Romiplostim self-administration by patients or caregivers may offer time/cost savings to healthcare professionals (HCPs) and convenience for patients who avoid weekly clinic visits. We performed an integrated analysis of five clinical trials to evaluate the efficacy and safety of romiplostim self-administration. Data were analyzed from adults with immune thrombocytopenia (ITP) who received weekly romiplostim via self-administration or from an HCP. Patients who achieved a stable romiplostim dose for ≥3 weeks (HCP group ≥5 weeks to provide an appropriate index date to enable comparisons with the self-administration group) with platelet counts ≥50 × 10 9 /L were eligible. In the self-administration (n = 621) vs HCP (n = 133) groups, respectively, median age was 53 vs 58 years, median time since primary ITP diagnosis was 3.7 vs 2.5 years, and median baseline platelet count at ITP diagnosis was 19.0 vs 20.0 × 10 9 /L. In the self-administration and HCP-dosed groups, median romiplostim treatment duration was 89 vs 52 weeks and median total number of doses was 81 vs 50, respectively. In the self-administration and HCP groups, respectively: 95.0% and 100.0% of patients achieved ≥1 platelet response (defined as weekly platelet count ≥50 × 10 9 /L without rescue medication in previous 4 weeks); the median percentage of weeks with a response was 94.5% and 95.9%; and rescue medication was used in 36.7% and 39.8% of patients. Self-administration did not adversely affect safety; duration-adjusted rates for all treatment-emergent adverse events (TEAEs) and bleeding TEAEs were numerically lower with self-administration. Romiplostim self-administration appears effective and well tolerated in eligible patients with ITP.",2020,Self-administration did not adversely affect safety; duration-adjusted rates for all treatment-emergent adverse events (TEAEs) and bleeding TEAEs were numerically lower with self-administration.,"['eligible patients with ITP', 'Patients who achieved a stable romiplostim dose for ≥3\u2009weeks', 'patients who avoid weekly clinic visits', 'patients with immune thrombocytopenia', '10 9 /L were eligible', 'adults with immune thrombocytopenia (ITP) who received weekly']","['self-administered romiplostim', 'romiplostim self-administration', 'romiplostim via self-administration or from an HCP']","['platelet response', 'median time since primary ITP diagnosis', 'Safety and efficacy', 'rescue medication', 'median romiplostim treatment duration']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0242584', 'cui_str': 'Autoimmune thrombocytopenia'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C2364481', 'cui_str': 'romiplostim'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0008952', 'cui_str': 'Clinic Visits'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C2364481', 'cui_str': 'romiplostim'}, {'cui': 'C0036589', 'cui_str': 'Self-administration of medication'}, {'cui': 'C0162531', 'cui_str': 'Hereditary coproporphyria'}]","[{'cui': 'C0005821', 'cui_str': 'thrombocytes'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0242584', 'cui_str': 'Autoimmune thrombocytopenia'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C2364481', 'cui_str': 'romiplostim'}, {'cui': 'C0444921', 'cui_str': 'Duration of treatment'}]",621.0,0.0679414,Self-administration did not adversely affect safety; duration-adjusted rates for all treatment-emergent adverse events (TEAEs) and bleeding TEAEs were numerically lower with self-administration.,"[{'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Kuter', 'Affiliation': 'Hematology Division, Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'Donald M', 'Initials': 'DM', 'LastName': 'Arnold', 'Affiliation': 'Canadian Blood Services and Department of Medicine, McMaster Centre for Transfusion Research, Michael G DeGroote School of Medicine, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Rodeghiero', 'Affiliation': 'Haematology Project Foundation, Affiliated to the Department of Haematology, S. Bortolo Hospital, Vicenza, Italy.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Janssens', 'Affiliation': 'Department of Hematology, University Hospitals Leuven, Campus Gasthuisberg, Leuven, Belgium.'}, {'ForeName': 'Dominik', 'Initials': 'D', 'LastName': 'Selleslag', 'Affiliation': 'Department of Hematology, AZ Sint Jan Brugge, Bruges, Belgium.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Bird', 'Affiliation': 'Division of Cancer Services, Princess Alexandra Hospital, Brisbane, Australia.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Newland', 'Affiliation': 'The Pathology Clinical Academic Group, The Royal London Hospital, London, UK.'}, {'ForeName': 'Jiri', 'Initials': 'J', 'LastName': 'Mayer', 'Affiliation': 'Department of Internal Medicine, Haematology and Oncology, Masaryk University and University Hospital Brno, Brno, Czech Republic.'}, {'ForeName': 'Kejia', 'Initials': 'K', 'LastName': 'Wang', 'Affiliation': 'Amgen Inc, Thousand Oaks, California, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Olie', 'Affiliation': 'Amgen (Europe) GmbH, Rotkreuz, Switzerland.'}]",American journal of hematology,['10.1002/ajh.25776'] 1839,32578800,Electric toothbrush for biofilm control in individuals with Down syndrome: a crossover randomized clinical trial.,"Poor oral hygiene seems to be the norm in children and teenagers with Down Syndrome (DS). Advances in design and types of toothbrushes may improve biofilm control. This randomized, single-blind, crossover clinical trial evaluated the effectiveness of electric toothbrushes regarding mechanical control of biofilm in children and teenagers with DS and their cooperation. Twenty-nine participants with DS, aged 6 to 14 years, used both types of toothbrushes: electric (ET) and manual (MT). The order of use of the different types of toothbrushes was randomly defined, including a 7-day period with each type with 7-day washout period in between. The Turesky-Quigley-Hein biofilm index was used before and after brushing to assess the effectiveness of the technique. Frankl's behavioral scale was used during toothbrushing to assess the participants' cooperation. Paired T-test, Mann Whitney, Chi-square, and Fisher's Exact tests were applied, with a significance level of 5%. The quantity of dental biofilm was significantly reduced after both brushing techniques (p < 0.001). However, no significant difference was found in total biofilm (ET: 0.73 ± 0.36; MT: 0.73 ± 0.34; p = 0.985) or % biofilm reduction (ET: 72.22%; MT: 70.96%; p = 0.762) after brushing between techniques or in % biofilm reduction between toothbrushes of age groups (6 -9 years, p = 0.919; 10-14 years, p = 0.671). Participants showed similar cooperation level with the two types of toothbrush (p = 1.000). The use of electric or manual toothbrush had no effect on the quantity of dental biofilm removed in children and teenagers with DS, nor did it influence their cooperation during the procedure.",2020,"The use of electric or manual toothbrush had no effect on the quantity of dental biofilm removed in children and teenagers with DS, nor did it influence their cooperation during the procedure.","['children and teenagers with DS', 'individuals with Down syndrome', 'Twenty-nine participants with DS, aged 6 to 14 years, used both types of', 'children and teenagers with Down Syndrome (DS', 'children and teenagers with DS and their cooperation']","['Electric toothbrush', 'electric toothbrushes', 'toothbrushes: electric (ET) and manual (MT', 'electric or manual toothbrush']","['quantity of dental biofilm', 'total biofilm', ""Frankl's behavioral scale"", 'cooperation level']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0013080', 'cui_str': 'Trisomy 21'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0450351', 'cui_str': '29'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C1740271', 'cui_str': 'Electric toothbrush'}, {'cui': 'C0183975', 'cui_str': 'Toothbrush'}, {'cui': 'C0013790', 'cui_str': 'Electricity'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0490733', 'cui_str': 'Manual toothbrush'}]","[{'cui': 'C1265611', 'cui_str': 'Quantity'}, {'cui': 'C0011365', 'cui_str': 'Health Services, Dental'}, {'cui': 'C0081786', 'cui_str': 'Biofilm'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",29.0,0.0316669,"The use of electric or manual toothbrush had no effect on the quantity of dental biofilm removed in children and teenagers with DS, nor did it influence their cooperation during the procedure.","[{'ForeName': 'Aryvelto Miranda', 'Initials': 'AM', 'LastName': 'Silva', 'Affiliation': 'Universidade Federal do Piauí - UFPI, Postgraduation Program in Dentistry, Teresina, PI, Brazil.'}, {'ForeName': 'Luís Fernando Bandeira', 'Initials': 'LFB', 'LastName': 'Miranda', 'Affiliation': 'Universidade Federal do Piauí - UFPI, Department of Restorative Dentistry, Teresina, PI, Brazil.'}, {'ForeName': 'Ana Sara Matos', 'Initials': 'ASM', 'LastName': 'AraÚjo', 'Affiliation': 'Universidade Federal do Piauí - UFPI, Department of Restorative Dentistry, Teresina, PI, Brazil.'}, {'ForeName': 'Raimundo Rosendo', 'Initials': 'RR', 'LastName': 'Prado JÚnior', 'Affiliation': 'Universidade Federal do Piauí - UFPI, Postgraduation Program in Dentistry, Teresina, PI, Brazil.'}, {'ForeName': 'Regina Ferraz', 'Initials': 'RF', 'LastName': 'Mendes', 'Affiliation': 'Universidade Federal do Piauí - UFPI, Postgraduation Program in Dentistry, Teresina, PI, Brazil.'}]",Brazilian oral research,['10.1590/1807-3107bor-2020.vol34.0057'] 1840,32574801,Emotion generation and regulation following an intrusion induction: Implications for taboo or autogenous obsessions.,"BACKGROUND AND OBJECTIVES Research demonstrates that autogenous (AO) and reactive obsessions (RO) differ in obsessional content; however, no experimental research has examined differences in emotion generation and regulation. Characterizing this taxonomy with respect to emotion generation and regulation could refine conceptualizations of obsessionality and optimize clinical interventions. METHODS Seventy undergraduates were randomly assigned to imagine a personally-relevant AO or RO. Subsequently, emotional reactivity was assessed. Participants then rated their emotion regulation efforts and the degree to which the intrusion violated their values. RESULTS Broadly aligning with expectations, bootstrapped linear regression models indicated that AOs led to a significant increase in self-conscious emotions (guilt, shame, and embarrassment), and these effects were stronger for those whose values were more severely threatened by the intrusion. A conditional process analysis revealed that the relationship between the AO condition and emotion regulation difficulties was explained by an increase in negative emotional reactivity, and the strength of this effect depended upon the degree of conflict with participants' values. LIMITATIONS The use of an analogue sample, and minimal emotional reactivity in the RO condition, threaten the ecological and external validity of the study. CONCLUSIONS The current study employed a novel experimental design demonstrating a meaningful relationship between AOs and both emotional activation and regulation. Results highlight the relevance of self-conscious emotions to the conceptualization of AOs and the utility of addressing them in the context of exposure therapy.",2020,"Broadly aligning with expectations, bootstrapped linear regression models indicated that AOs led to a significant increase in self-conscious emotions (guilt, shame, and embarrassment), and these effects were stronger for those whose values were more severely threatened by the intrusion.","['taboo or autogenous obsessions', 'Seventy undergraduates']",['imagine a personally-relevant AO or RO'],"['negative emotional reactivity', 'self-conscious emotions (guilt, shame, and embarrassment', 'AO condition and emotion regulation difficulties', 'emotional reactivity']","[{'cui': 'C0039227', 'cui_str': 'Taboo'}, {'cui': 'C0443145', 'cui_str': 'Autogenous'}, {'cui': 'C0233697', 'cui_str': 'Obsessional thoughts'}, {'cui': 'C3816957', 'cui_str': '70'}]","[{'cui': 'C0443145', 'cui_str': 'Autogenous'}, {'cui': 'C0205332', 'cui_str': 'Reactive'}, {'cui': 'C0233697', 'cui_str': 'Obsessional thoughts'}]","[{'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0234421', 'cui_str': 'Consciousness'}, {'cui': 'C0018379', 'cui_str': 'Feeling guilt'}, {'cui': 'C0036938', 'cui_str': 'Shame'}, {'cui': 'C0679112', 'cui_str': 'Embarrassment'}, {'cui': 'C0443145', 'cui_str': 'Autogenous'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}]",70.0,0.0314195,"Broadly aligning with expectations, bootstrapped linear regression models indicated that AOs led to a significant increase in self-conscious emotions (guilt, shame, and embarrassment), and these effects were stronger for those whose values were more severely threatened by the intrusion.","[{'ForeName': 'Noah Chase', 'Initials': 'NC', 'LastName': 'Berman', 'Affiliation': 'College of the Holy Cross, Department of Psychology, 1 College St, Worcester, MA, 01610, USA. Electronic address: nberman@holycross.edu.'}, {'ForeName': 'Jumi', 'Initials': 'J', 'LastName': 'Hayaki', 'Affiliation': 'College of the Holy Cross, Department of Psychology, 1 College St, Worcester, MA, 01610, USA.'}, {'ForeName': 'Abigail', 'Initials': 'A', 'LastName': 'Szkutak', 'Affiliation': 'College of the Holy Cross, Department of Psychology, 1 College St, Worcester, MA, 01610, USA.'}]",Journal of behavior therapy and experimental psychiatry,['10.1016/j.jbtep.2020.101593'] 1841,32574844,"Effect of soluble corn fiber supplementation for 1 year on bone metabolism in children, the MetA-bone trial: Rationale and design.","Calcium intake is critical for adequate bone mineralization in adolescence, but it is usually inadequate in US adolescents. A strategy to maximize bone mineralization is to increase calcium absorption, which could be achieved by soluble corn fiber (SCF). There are no studies determining the long-term effects of SCF on bone mass in children. OBJECTIVES To determine the effect of one-year SCF supplementation compared to placebo on bone mass and bone biomarkers in children with low habitual calcium intake. We hypothesize that SCF supplementation will result in a higher bone mineral content and higher levels of bone formation and lower bone resorption biomarkers. METHODS 240 healthy children (10-13 years), with usual low calcium intake, will be randomized to four experimental groups for 1 year: (1) SCF (12 g/d); (2) SCF (12 g/d) + 600 mg/d of calcium; (3) Placebo (maltodextrin); and (4) Placebo +600 mg/d of calcium. The supplements have been pre-mixed with a flavored powder beverage and participants will only need to dilute it in water and drink this twice per day. Bone will be measured using dual energy x-ray absorptiometry (DXA) at baseline, 6 and 12 months. Serum bone biomarkers will be measured at baseline and at 12 months. CONCLUSIONS If supplementing diets with SCF lead to higher bone mass during adolescence, this could help achieve the genetic potential for PBM and to start adult life with stronger bones. If successful, SCF can be incorporated into diets for promoting bone health in adolescents.",2020,"We hypothesize that SCF supplementation will result in a higher bone mineral content and higher levels of bone formation and lower bone resorption biomarkers. ","['240 healthy children (10-13\u202fyears', 'adolescents', 'children with low habitual calcium intake', 'children']","['SCF', 'usual low calcium intake', 'soluble corn fiber supplementation', 'calcium; (3) Placebo (maltodextrin', 'Calcium intake', 'SCF supplementation', 'Placebo +600\u202fmg/d of calcium', 'placebo']","['bone metabolism', 'Serum bone biomarkers', 'bone mineral content and higher levels of bone formation and lower bone resorption biomarkers', 'bone mass and bone biomarkers']","[{'cui': 'C4319600', 'cui_str': '240'}, {'cui': 'C0686744', 'cui_str': 'Well child'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205353', 'cui_str': 'Habitual'}, {'cui': 'C0489458', 'cui_str': 'Calcium intake'}]","[{'cui': 'C0010028', 'cui_str': 'Zea mays'}, {'cui': 'C0012173', 'cui_str': 'Dietary fiber'}, {'cui': 'C0860967', 'cui_str': 'Calcium low'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0065601', 'cui_str': 'maltodextrin'}, {'cui': 'C0489458', 'cui_str': 'Calcium intake'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}]","[{'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0005963', 'cui_str': 'Bone Mineral Content'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0029433', 'cui_str': 'Bone formation'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0005974', 'cui_str': 'Bone resorption'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}]",240.0,0.314368,"We hypothesize that SCF supplementation will result in a higher bone mineral content and higher levels of bone formation and lower bone resorption biomarkers. ","[{'ForeName': 'C', 'Initials': 'C', 'LastName': 'Palacios', 'Affiliation': 'Dietetics and Nutrition Department, Robert Stempel College of Public Health & Social Work, Florida International University, 11200 SW 8th Street, Miami, FL\xa033199, United States of America. Electronic address: cristina.palacios@fiu.edu.'}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Trak-Fellermeier', 'Affiliation': 'Dietetics and Nutrition Department, Robert Stempel College of Public Health & Social Work, Florida International University, 11200 SW 8th Street, Miami, FL\xa033199, United States of America.'}, {'ForeName': 'C M', 'Initials': 'CM', 'LastName': 'Pérez', 'Affiliation': 'Department of Biostatistics and Epidemiology, Graduate School of Public Health, Medical Sciences Campus, University of Puerto Rico, 11200 SW 8th Street, Miami, FL\xa033199, United States of America.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Huffman', 'Affiliation': 'Dietetics and Nutrition Department, Robert Stempel College of Public Health & Social Work, Florida International University, 11200 SW 8th Street, Miami, FL\xa033199, United States of America.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Hernandez Suarez', 'Affiliation': 'Vice Provost for Population Health and Well-being, Florida International University, 11200 SW 8th Street, Miami, FL\xa033199, United States of America.'}, {'ForeName': 'Z', 'Initials': 'Z', 'LastName': 'Bursac', 'Affiliation': 'Department of Biostatistics, Robert Stempel College of Public Health, Florida International University, 11200 SW 8th Street, Miami, FL\xa033199, United States of America.'}, {'ForeName': 'T B', 'Initials': 'TB', 'LastName': 'Gambon', 'Affiliation': 'Pediatrician, Citrus Health Network, 551 W 51st Pl, Hialeah, FL 33012, United States of America.'}, {'ForeName': 'C H', 'Initials': 'CH', 'LastName': 'Nakatsu', 'Affiliation': 'Department of Agronomy, College of Agriculture, Purdue University, 915 West State Street, West Lafayette, IN 47907-2053, United States of America.'}, {'ForeName': 'C M', 'Initials': 'CM', 'LastName': 'Weaver', 'Affiliation': 'Distinguished Professor emerita, Purdue University, 610 Purdue Mall, West Lafayette, IN 47907, United States of America.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106061'] 1842,32584285,Photobiomodulation Effect of Low-level Laser Therapy as a Palliative Treatment of Symptomatic Geographic Tongue (A Double-blinded Randomized Clinical Trial).,"AIM To evaluate the effectiveness of photobiomodulation (PBM) of low-level laser therapy (LLLT) as a palliative treatment of symptomatic geographic tongue. MATERIALS AND METHODS This randomized double-blinded controlled clinical trial was performed on 50 patients with symptomatic geographic tongue (GT). Participants were allocated randomly into study and control groups. A 660-nm diode laser was applied on randomly selected patients of the study group ( n = 25) over the complained site for 2 minutes with continuous laser beam application. For the control group ( n = 25), no application of 660-nm diode laser was performed. None of the participants were aware if they received the LLLT or placebo treatment. Patients were assessed for the level of pain, burning sensation, and size of the lesion before starting LLLT ""T0"" and during recall visit ""T1, T2, and T3."" RESULTS The study group showed a low level of pain, burning sensation, and better healing with statistically significant differences at T2 and T3 of the follow-up period, with a level of significance was set at p < 0.05. CONCLUSION Low-level laser therapy can be used to adequately relieve significant discomforts associated with GT and accelerate healing and restoring of the patient's quality of life. CLINICAL SIGNIFICANCE To develop a framework based on the results regarding the photobiomodulation effect of a 660-nm diode laser to relieve pain and burning sensation associated with symptomatic GT, which increases patients' perception toward the services provided to them.",2020,"The study group showed a low level of pain, burning sensation, and better healing with statistically significant differences at T2 and T3 of the follow-up period, with a level of significance was set at p < 0.05. ","['50 patients with symptomatic geographic tongue (GT', 'symptomatic geographic tongue']","['Low-level Laser Therapy', 'LLLT or placebo', '660-nm diode laser', 'photobiomodulation (PBM) of low-level laser therapy (LLLT', 'Low-level laser therapy']","['level of pain, burning sensation, and size of the lesion before starting LLLT ""T0', 'low level of pain, burning sensation, and better healing']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0017677', 'cui_str': 'Geographic tongue'}]","[{'cui': 'C0279027', 'cui_str': 'Low power laser therapy'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4517845', 'cui_str': '660'}, {'cui': 'C0392254', 'cui_str': 'Semiconductor laser device'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0085624', 'cui_str': 'Burning sensation'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0279027', 'cui_str': 'Low power laser therapy'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}]",50.0,0.157638,"The study group showed a low level of pain, burning sensation, and better healing with statistically significant differences at T2 and T3 of the follow-up period, with a level of significance was set at p < 0.05. ","[{'ForeName': 'Islam', 'Initials': 'I', 'LastName': 'Saad', 'Affiliation': 'Department of Periodontology and Oral Medicine, College of Dentistry, Qassim University, Kingdom of Saudi Arabia, Phone: +966 531017409, e-mail: Dr.islam.saad@qudent.org.'}]",The journal of contemporary dental practice,[] 1843,32584367,Efficacy and Safety of Trastuzumab Emtansine Plus Capecitabine vs Trastuzumab Emtansine Alone in Patients With Previously Treated ERBB2 (HER2)-Positive Metastatic Breast Cancer: A Phase 1 and Randomized Phase 2 Trial.,"Importance ERBB2 (HER2)-targeted therapy provides benefits in metastatic breast cancer (mBC) and gastric cancer, but additional treatments are needed to maximize efficacy and quality of life. Objective To determine maximum tolerated doses (MTDs) of trastuzumab emtansine (T-DM1) plus capecitabine in patients with previously treated ERBB2-positive mBC and locally advanced/metastatic gastric cancer (LA/mGC) (phase 1) and the efficacy and safety of this combination vs T-DM1 alone in patients with mBC (phase 2). Design, Setting, and Participants The MTD in phase 1 was assessed using a 3 + 3 design with capecitabine dose modification. Phase 2 was an open-label, randomized, international multicenter study of patients with mBC treated with T-DM1 plus capecitabine or T-DM1 alone. Eligible patients had previously treated ERBB2-positive mBC or LA/mGC with no prior chemotherapy treatment for advanced disease. Interventions Patients in the phase 1 mBC cohort received capecitabine (750 mg/m2, 700 mg/m2, or 650 mg/m2 twice daily, days 1-14 of a 3-week cycle) plus T-DM1 3.6 mg/kg every 3 weeks. Patients with LA/mGC received capecitabine at the mBC phase 1 MTD, de-escalating as needed, plus T-DM1 2.4 mg/kg weekly. In phase 2, patients with mBC were randomized (1:1) to receive capecitabine (at the phase 1 MTD) plus T-DM1 or T-DM1 alone. Main Outcomes and Measures The phase 1 primary objective was to identify the MTD of capecitabine plus T-DM1. The phase 2 primary outcome was investigator-assessed overall response rate (ORR). Results In phase 1, the median (range) age was 54.0 (37-71) and 57.5 (53-70) years for patients with mBC and patients with LA/mGC, respectively. The capecitabine MTD was identified as 700 mg/m2 in 11 patients with mBC and 6 patients with LA/mGC evaluable for dose-limiting toxic effects. In phase 2, between October 2014 and April 2016, patients with mBC (median [range] age, 52.0 [28-80] years) were randomized to receive combination therapy (n = 81) or T-DM1 (n = 80). The ORR was 44% (36 of 81 patients) and 36% (29 of 80 patients) in the combination and T-DM1 groups, respectively (difference, 8.2%; 90% CI, -4.5 to 20.9; P = .34; clinical cutoff, May 31, 2017). Adverse events (AEs) were reported in 78 of 82 patients (95%) in the combination group, with 36 (44%) experiencing grade 3-4 AEs, and 69 of 78 patients (88%) in the T-DM1 group, with 32 (41%) experiencing grade 3-4 AEs. No grade 5 AEs were reported. Conclusions and Relevance Adding capecitabine to T-DM1 did not statistically increase ORR associated with T-DM1 in patients with previously treated ERBB2-positive mBC. The combination group reported more AEs, but with no unexpected toxic effects. Trial Registration ClinicalTrials.gov Identifier: NCT01702558.",2020,"No grade 5 AEs were reported. ","['patients with previously treated ERBB2-positive mBC and locally advanced/metastatic gastric cancer (LA/mGC', 'patients with previously treated ERBB2-positive mBC', 'patients with mBC treated with', 'patients with mBC (phase 2', 'Eligible patients had previously treated ERBB2-positive mBC or LA/mGC with no prior chemotherapy treatment for advanced disease', 'HER2)-Positive Metastatic Breast Cancer', 'In phase 2, between October 2014 and April 2016, patients with mBC (median [range] age, 52.0 [28-80] years', 'metastatic breast cancer (mBC) and gastric cancer', 'Patients With Previously Treated ERBB2', 'patients with mBC']","['HER2)-targeted therapy', 'combination therapy', 'capecitabine (at the phase 1 MTD) plus T-DM1 or T-DM1 alone', 'T-DM1 plus capecitabine or T-DM1 alone', 'capecitabine MTD', 'capecitabine', 'trastuzumab emtansine (T-DM1) plus capecitabine', 'Trastuzumab Emtansine Plus Capecitabine vs Trastuzumab Emtansine Alone']","['Efficacy and Safety', 'investigator-assessed overall response rate (ORR', 'Importance\n\n\nERBB2', 'ORR', 'efficacy and safety', 'Adverse events (AEs', 'toxic effects']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0069515', 'cui_str': 'Oncogene protein HER-2/neu'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0278488', 'cui_str': 'Breast cancer stage IV'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0278498', 'cui_str': 'Gastric cancer stage IV'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0282460', 'cui_str': 'Clinical Trials, Phase II as Topic'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0024623', 'cui_str': 'Malignant tumor of stomach'}]","[{'cui': 'C0069515', 'cui_str': 'Oncogene protein HER-2/neu'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0009429', 'cui_str': 'Combination therapy'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C0439559', 'cui_str': 'Phase 1'}, {'cui': 'C0752079', 'cui_str': 'Maximal Tolerated Dose'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C2935436', 'cui_str': 'ado-trastuzumab emtansine'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0069515', 'cui_str': 'Oncogene protein HER-2/neu'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}]",,0.170456,"No grade 5 AEs were reported. ","[{'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Cortés', 'Affiliation': 'Quirónsalud Group, IOB Institute of Oncology, Madrid, Spain.'}, {'ForeName': 'Véronique', 'Initials': 'V', 'LastName': 'Diéras', 'Affiliation': 'Centre Eugène Marquis, Rennes, France.'}, {'ForeName': 'Sylvie', 'Initials': 'S', 'LastName': 'Lorenzen', 'Affiliation': 'Hematology/Medical Oncology, 3rd Department of Internal Medicine, Klinikum rechts der Isar, Technische Universität München, Munich, Germany.'}, {'ForeName': 'Filippo', 'Initials': 'F', 'LastName': 'Montemurro', 'Affiliation': 'Multidisciplinary Oncology Outpatient Clinic, Candiolo Cancer Institute, FPO-IRCCS, Candiolo, Italy.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Riera-Knorrenschild', 'Affiliation': 'Klinik für Hämatologie, Onkologie und Immunologie, Universitätsklinikum Gießen und Marburg, Standort Marburg, Philipps-Universität Marburg, Baldingerstraße, Marburg, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Thuss-Patience', 'Affiliation': 'Department of Haematology, Oncology and Tumorimmunology, Campus Virchow-Klinikum, Charité-University Medicine Berlin, Berlin, Germany.'}, {'ForeName': 'Giacomo', 'Initials': 'G', 'LastName': 'Allegrini', 'Affiliation': 'Division of Medical Oncology, Department of Oncology, Pontedera Hospital, Azienda L Toscana Nord Ovest, Pisa, Italy.'}, {'ForeName': 'Michelino', 'Initials': 'M', 'LastName': 'De Laurentiis', 'Affiliation': 'Division of Breast Medical Oncology, Istituto Nazionale Tumori IRCCS ""Fondazione G. Pascale"", Napoli, Italy.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Lohrisch', 'Affiliation': 'BC Cancer, Vancouver Cancer Centre, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Oravcová', 'Affiliation': '2nd Department of Oncology, Faculty of Medicine, Comenius University, Bratislava, Slovak Republic.'}, {'ForeName': 'Jose M', 'Initials': 'JM', 'LastName': 'Perez-Garcia', 'Affiliation': 'Quirónsalud Group, IOB Institute of Oncology, Barcelona, Spain.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Ricci', 'Affiliation': 'Institut Curie, Paris, France.'}, {'ForeName': 'Dina', 'Initials': 'D', 'LastName': 'Sakaeva', 'Affiliation': 'Department of Chemotherapy, Republican Clinical Oncology Center, Ufa, Russia.'}, {'ForeName': 'Rosanne', 'Initials': 'R', 'LastName': 'Serpanchy', 'Affiliation': 'BC Cancer, Vancouver Cancer Centre, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Jozef', 'Initials': 'J', 'LastName': 'Šufliarský', 'Affiliation': '2nd Department of Oncology, Faculty of Medicine, Comenius University, Bratislava, Slovak Republic.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Vidal', 'Affiliation': ""Vall d'Hebron Institute of Oncology, Barcelona, Spain.""}, {'ForeName': 'Natsumi', 'Initials': 'N', 'LastName': 'Irahara', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Wohlfarth', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'Mounir', 'Initials': 'M', 'LastName': 'Aout', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Basel, Switzerland.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Gelmon', 'Affiliation': 'BC Cancer, Vancouver Cancer Centre, Vancouver, British Columbia, Canada.'}]",JAMA oncology,['10.1001/jamaoncol.2020.1796'] 1844,32584384,Association of Intravitreal Aflibercept With Optical Coherence Tomography Angiography Vessel Density in Patients With Proliferative Diabetic Retinopathy: A Secondary Analysis of a Randomized Clinical Trial.,"Importance Although previous studies have evaluated the association between anti-vascular endothelial growth factor therapy and macular vessel density, they were confounded by the presence of macular edema, which may be associated with artifacts and segmentation errors in optical coherence tomography angiography (OCTA). Objective To evaluate the association of intravitreal aflibercept with changes in macular vascular density using OCTA in patients with proliferative diabetic retinopathy without diabetic macular edema. Design, Setting, and Participants This post hoc analysis of a randomized clinical trial used data on 40 eyes of 40 patients with proliferative diabetic retinopathy without diabetic macular edema who were enrolled in the Intravitreal Aflibercept for Retinal Nonperfusion in Proliferative Diabetic Retinopathy (RECOVERY) clinical trial from August 1, 2016, to June 31, 2017. Three patients were lost to follow-up at month 12, and 5 patients were excluded from analysis because of poor OCTA image quality, leaving 16 patients in each cohort in the final analysis. Data analysis was performed from March 1, 2018, to January 15, 2019. Intervention In the RECOVERY trial, patients were randomized into cohorts receiving 2 mg of aflibercept injections monthly (n = 20) or quarterly (n = 20) and treated for 12 months. Main Outcomes and Measures The percentage of vascular density (in total scan and foveal and parafoveal regions) was compared before and after 12 months of therapy. Results The sample for this OCTA analysis included 32 eyes from 32 patients (mean [SD] age, 48.37 [12.30] years; 17 [53.1%] male). The mean (SD) total scan vascular density for the superficial vascular complex was 42.28% (4.03%; 95% CI, 40.63%-43.93%) at baseline and 39.64% (4.01%; 95% CI, 37.91%-41.37%) at month 12 (P = .69). For the deep vascular complex, the mean (SD) vascular density was 48.42% (4.99%; 95% CI, 46.36%-50.47%) at baseline and 45.69% (4.63%; 95% CI, 43.69%-47.70%) at month 12 (P = .40). For the choriocapillaris, the mean (SD) vascular density was 64.42% (3.36%; 95% CI, 63.04%-65.81%) at baseline and 62.55% (4.79%; 95% CI, 60.48%-64.62%) at month 12 (P = .16). There was no difference in vascular density parameters between monthly and quarterly injection arms at month 12. Conclusions and Relevance In this study, macular vascular density did not change after 12 months of intravitreal aflibercept therapy. Because nonperfusion is expected to progress in diabetic retinopathy, this finding may represent a beneficial association between anti-vascular endothelial growth factor therapy and macular vascular density. Trial Registration ClinicalTrials.gov Identifier: NCT02863354.",2020,"In this study, macular vascular density did not change after 12 months of intravitreal aflibercept therapy.","['32 eyes from 32 patients (mean [SD] age, 48.37', 'Patients With Proliferative Diabetic Retinopathy', '40 eyes of 40 patients with proliferative diabetic retinopathy without diabetic macular edema who were enrolled in the Intravitreal Aflibercept for Retinal Nonperfusion in Proliferative Diabetic Retinopathy (RECOVERY) clinical trial from August 1, 2016, to June 31, 2017', 'patients with proliferative diabetic retinopathy without diabetic macular edema', '12.30] years; 17 [53.1%] male']","['aflibercept injections', 'OCTA', 'Intravitreal Aflibercept With Optical Coherence Tomography Angiography Vessel Density', 'intravitreal aflibercept']","['macular vascular density', 'mean (SD) total scan vascular density for the superficial vascular complex', 'percentage of vascular density (in total scan and foveal and parafoveal regions', 'mean (SD) vascular density', 'vascular density parameters']","[{'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0154830', 'cui_str': 'Proliferative retinopathy with diabetes mellitus'}, {'cui': 'C0730285', 'cui_str': 'Macular edema due to diabetes mellitus'}, {'cui': 'C1517572', 'cui_str': 'Intravitreal route'}, {'cui': 'C1134659', 'cui_str': 'aflibercept'}, {'cui': 'C4049512', 'cui_str': 'Retinal nonperfusion'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C4050106', 'cui_str': 'aflibercept Injection'}, {'cui': 'C0920367', 'cui_str': 'Optical coherence tomography'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}, {'cui': 'C1517572', 'cui_str': 'Intravitreal route'}, {'cui': 'C1134659', 'cui_str': 'aflibercept'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0178587', 'cui_str': 'Density'}]","[{'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0205124', 'cui_str': 'Superficial'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0442137', 'cui_str': 'Parafoveal'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",3.0,0.299412,"In this study, macular vascular density did not change after 12 months of intravitreal aflibercept therapy.","[{'ForeName': 'Ahmed Roshdy', 'Initials': 'AR', 'LastName': 'Alagorie', 'Affiliation': 'Doheny Image Reading Center, Doheny Eye Institute, Los Angeles, California.'}, {'ForeName': 'Muneeswar Gupta', 'Initials': 'MG', 'LastName': 'Nittala', 'Affiliation': 'Doheny Image Reading Center, Doheny Eye Institute, Los Angeles, California.'}, {'ForeName': 'Swetha', 'Initials': 'S', 'LastName': 'Velaga', 'Affiliation': 'Doheny Image Reading Center, Doheny Eye Institute, Los Angeles, California.'}, {'ForeName': 'Brenda', 'Initials': 'B', 'LastName': 'Zhou', 'Affiliation': 'Retina Consultants of Houston, Houston, Texas.'}, {'ForeName': 'Alexander M', 'Initials': 'AM', 'LastName': 'Rusakevich', 'Affiliation': 'Retina Consultants of Houston, Houston, Texas.'}, {'ForeName': 'Charles C', 'Initials': 'CC', 'LastName': 'Wykoff', 'Affiliation': 'Retina Consultants of Houston, Houston, Texas.'}, {'ForeName': 'SriniVas R', 'Initials': 'SR', 'LastName': 'Sadda', 'Affiliation': 'Doheny Image Reading Center, Doheny Eye Institute, Los Angeles, California.'}]",JAMA ophthalmology,['10.1001/jamaophthalmol.2020.2130'] 1845,32438828,Participation in and outcomes from a 12-month tailored exercise programme for people with multiple sclerosis (MSTEP©): a randomized trial.,"OBJECTIVE To estimate, among people with multiple sclerosis, the extent to which a personally tailored exercise programme (MSTEP©) resulted in greater improvements in exercise capacity and related outcomes over 12 months in comparison with general exercise guidelines. DESIGN Two-group randomized trial. SUBJECTS Ambulatory and sedentary. INTERVENTIONS MSTEP©, a personally adapted exercise regimen done on most days including two days of high intensity exercise; guidelines recommending 30 minutes of moderate intensity aerobic and strength training two times per week. MAIN MEASURES Primary outcome was peak oxygen consumption (VO 2peak ) at 12 months; secondary outcomes were composite measures of physical function, fatigue, and health-related quality of life. RESULTS In total, 137 people were randomized, 66 were lost over 12 months leaving 71 with outcome data, 34 in MSTEP© group, and 37 in the Guideline group. Exercise enjoyment and confidence and exercise-induced fatigue predicted retention. There were no differences between groups on the proportion making a 10% increase in VO 2peak (27.1% MSTEP© vs 29.6% Guidelines; OR: 0.83; 95% CI: 0.23-3.08) by the 12 month assessment. The effect on fatigue was larger in the MSTEP© group than the Guideline groups (OR: 1.59; 95% CI: 0.93-2.74), the effect on physical function was more modest (OR: 1.35; 95% CI: 0.80-2.25), and null for health-related quality of life outcomes. CONCLUSIONS The disappointing exercise retention suggests that people with multiple sclerosis may not consider exercise important to their brain health. Either type of exercise resulted in stable exercise capacity over 1 year in those sticking with the programme.",2020,The effect on fatigue was larger in the MSTEP,"['people with multiple sclerosis', 'people with multiple sclerosis (MSTEP©', '137 people were randomized, 66 were lost over 12\u2009months leaving 71 with outcome data, 34 in MSTEP© group, and 37 in the Guideline group', 'Ambulatory and sedentary']","['MSTEP', 'tailored exercise programme']","['VO 2peak', 'physical function', 'fatigue', 'stable exercise capacity', 'peak oxygen consumption (VO 2peak ', 'physical function, fatigue, and health-related quality of life', 'Exercise enjoyment and confidence and exercise-induced fatigue predicted retention']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C4517569', 'cui_str': '137'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0679105', 'cui_str': 'Pleasure'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C2732413', 'cui_str': 'Postexertional fatigue'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}]",137.0,0.195875,The effect on fatigue was larger in the MSTEP,"[{'ForeName': 'Nancy E', 'Initials': 'NE', 'LastName': 'Mayo', 'Affiliation': 'Center for Outcomes Research and Evaluation, Research Institute of McGill University Health Centre, Montreal, QC, Canada.'}, {'ForeName': 'Kedar Kv', 'Initials': 'KK', 'LastName': 'Mate', 'Affiliation': 'Center for Outcomes Research and Evaluation, Research Institute of McGill University Health Centre, Montreal, QC, Canada.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Reid', 'Affiliation': 'Human Kinetics Department, St Francis Xavier University, Antigonish, NS, Canada.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Duquette', 'Affiliation': 'Départment de Neurologie, Faculté de Médecine, Université de Montréal, Montreal, QC, Canada.'}, {'ForeName': 'Yves', 'Initials': 'Y', 'LastName': 'Lapierre', 'Affiliation': 'Montreal Neurological Hospital, Department of Neurology and Neurosurgery, McGill University, Montreal, QC, Canada.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Barclay', 'Affiliation': 'College of Rehabilitation Sciences, Rady Faculty of Health Sciences, Department of Physical Therapy, University of Manitoba, Winnipeg, MA, Canada.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Bayley', 'Affiliation': 'Toronto Rehabilitation Center, University Health Network, Toronto, ON, Canada.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Bartlett', 'Affiliation': 'Division of Clinical Epidemiology, Department of Medicine, Center for Outcomes Research and Evaluation, Research Institute of McGill University Health Centre, McGill University, Montreal, QC, Canada.'}, {'ForeName': 'Ross', 'Initials': 'R', 'LastName': 'Andersen', 'Affiliation': 'Department of Kinesiology and Physical Education, McGill University, Montreal, QC, Canada.'}]",Clinical rehabilitation,['10.1177/0269215520923089'] 1846,32442673,Salivary oxytocin after oxytocin administration: Examining the moderating role of childhood trauma.,"Although oxytocin administration influences behavior, its effects on peripheral oxytocin concentrations are mixed and derived from studies on healthy subjects. Additionally, trauma attenuates the behavioral effects of oxytocin, but it is unknown whether it also influences its effect on peripheral circulation. This study examined whether salivary oxytocin increased after oxytocin administration and whether trauma attenuated this effect. We conducted a randomized, double-blind, placebo-controlled, within-subjects study in 100 male adolescents living in residential youth care facilities. Participants self-administered intranasally 24 IU of oxytocin and placebo (one week later) and provided a saliva sample before and 15 min after administration. Salivary oxytocin increased significantly after oxytocin administration, but this effect might be inflated by exogenous oxytocin reaching the throat. Trauma did not moderate this effect. Our findings suggest that trauma did not attenuate the effect of oxytocin administration on salivary oxytocin, but more robust methodologies are recommended to draw more solid conclusions.",2020,Trauma did not moderate this effect.,"['100 male adolescents living in residential youth care facilities', 'healthy subjects']","['oxytocin', 'salivary oxytocin', 'Salivary oxytocin', 'oxytocin and placebo', 'placebo']","['Salivary oxytocin', 'peripheral oxytocin concentrations']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0001589', 'cui_str': 'Adolescents, Male'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",100.0,0.442201,Trauma did not moderate this effect.,"[{'ForeName': 'Iro', 'Initials': 'I', 'LastName': 'Fragkaki', 'Affiliation': 'Radboud University, Behavioural Science Institute, Montessorilaan 3, 6525 HR, Nijmegen, the Netherlands. Electronic address: i.fragkaki@pwo.ru.nl.'}, {'ForeName': 'Jeffrey C', 'Initials': 'JC', 'LastName': 'Glennon', 'Affiliation': 'Radboud University Medical Center, Donders Institute for Brain, Cognition and Behaviour, Geert Grooteplein Zuid 10, 6525 GA, Nijmegen, the Netherlands.'}, {'ForeName': 'Maaike', 'Initials': 'M', 'LastName': 'Cima', 'Affiliation': 'Radboud University, Behavioural Science Institute, Montessorilaan 3, 6525 HR, Nijmegen, the Netherlands.'}]",Biological psychology,['10.1016/j.biopsycho.2020.107903'] 1847,32442688,"A commentary on ""Efficacy of single layered intestinal anastomosis over double layered intestinal anastomosis - An open labeled, randomized controlled trial"" - What is missing for a careful analysis? The importance of considering all the factors involved.",,2020,,[],['single layered intestinal anastomosis'],[],[],"[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0192711', 'cui_str': 'Anastomosis of intestine'}]",[],,0.102212,,"[{'ForeName': 'Leandro Ryuchi', 'Initials': 'LR', 'LastName': 'Iuamoto', 'Affiliation': 'Department of Surgery, Laboratory of Medical Research 02, Division of Human Structural Topography, University of Sao Paulo School of Medicine, Sao Paulo, SP, Brazil.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Meyer', 'Affiliation': 'General and Gastrointestinal (GI) Surgeon, Hospital Das Clínicas, Department of Gastroenterology, University of Sao Paulo School of Medicine, Sao Paulo, SP, Brazil. Electronic address: alberto.meyer@usp.br.'}]","International journal of surgery (London, England)",['10.1016/j.ijsu.2020.05.045'] 1848,32557560,Spatial regression and spillover effects in cluster randomized trials with count outcomes.,"This paper describes methodology for analyzing data from cluster randomized trials with count outcomes, taking indirect effects as well spatial effects into account. Indirect effects are modeled using a novel application of a measure of depth within the intervention arm. Both direct and indirect effects can be estimated accurately even when the proposed model is misspecified. We use spatial regression models with Gaussian random effects, where the individual outcomes have distributions overdispersed with respect to the Poisson, and the corresponding direct and indirect effects have a marginal interpretation. To avoid spatial confounding, we use orthogonal regression, in which random effects represent spatial dependence using a homoscedastic and dimensionally reduced modification of the intrinsic conditional autoregression model. We illustrate the methodology using spatial data from a pair-matched cluster randomized trial against the dengue mosquito vector Aedes aegypti, done in Trujillo, Venezuela.",2020,"We illustrate the methodology using spatial data from a pair-matched cluster randomized trial against the dengue mosquito vector Aedes aegypti, done in Trujillo, Venezuela.",[],[],[],[],[],[],,0.0463177,"We illustrate the methodology using spatial data from a pair-matched cluster randomized trial against the dengue mosquito vector Aedes aegypti, done in Trujillo, Venezuela.","[{'ForeName': 'Karim', 'Initials': 'K', 'LastName': 'Anaya-Izquierdo', 'Affiliation': 'Department of Mathematical Sciences, University of Bath, Bath, UK.'}, {'ForeName': 'Neal', 'Initials': 'N', 'LastName': 'Alexander', 'Affiliation': 'MRC Tropical Epidemiology, London School of Hygiene and Tropical Medicine, London, UK.'}]",Biometrics,['10.1111/biom.13316'] 1849,32559003,Evaluation and comparison of histologic changes and implant survival in extraction sites immediately grafted with two different xenografts: A randomized clinical pilot study.,"OBJECTIVES The purpose of this prospective, single-center randomized pilot study was to histologically evaluate and compare vital bone development in premolar and molar-extraction sites grafted with two different bovine-derived xenografts. The secondary outcome of interest was implant survival in the grafted sites. MATERIALS AND METHODS Adult patients in need of at least two tooth extractions were enrolled. A paired design was used; each patient received at least one of each type of graft at different sites. Each extraction site was randomized to one of two xenograft treatment groups. A resorbable membrane was always placed, and primary intention soft tissue closure was achieved. Four months later, implants were placed and a trephine drill was used to remove bone cores for histologic and histomorphometric analysis. RESULTS Sixteen patients with 40 extraction sites were enrolled; 20 sites were grafted with one type of xenograft and 20 with another. Mean patient age was 53.5 years, and 65% of patients were male. Evaluation of bone core samples taken from grafted sites showed no significant difference in the mean value of percentage of new bone formation between the different grafted sites (33.4% and 32.4%, p = .76). Cumulative implant survival was 97.5% at the 24-month follow-up visit. CONCLUSION Within the limitations of this pilot study, no statistically significant differences in new bone growth between sites grafted with two different types of xenograft were found. Both graft materials promoted the formation of new bone and provided osseous support for implant placement after socket grafting.",2020,"Evaluation of bone core samples taken from grafted sites showed no significant difference in the mean value of percentage of new bone formation between the different grafted sites (33.4 % and 32.4 %, p=0.76).","['Mean patient age was 53.5 years, and 65% of patients were male', 'Sixteen patients with 40 extraction sites were enrolled; 20 sites were grafted with one type of xenograft and 20 with another', 'Adult patients in need of at least 2 tooth extractions were enrolled', 'premolar and molar extraction sites grafted with 2 different bovine-derived xenografts']",[],"['new bone growth', 'Histologic Changes and Implant Survival', 'implant survival', 'Cumulative implant survival', 'mean value of percentage of new bone formation']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0520484', 'cui_str': 'Xenogeneic transplantation'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0040440', 'cui_str': 'Tooth extraction'}, {'cui': 'C1704302', 'cui_str': 'Structure of premolar tooth'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}, {'cui': 'C0007452', 'cui_str': 'Cattle'}]",[],"[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0971859', 'cui_str': 'Bone Growth'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0334168', 'cui_str': 'New bone formation'}]",16.0,0.0481422,"Evaluation of bone core samples taken from grafted sites showed no significant difference in the mean value of percentage of new bone formation between the different grafted sites (33.4 % and 32.4 %, p=0.76).","[{'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Sivolella', 'Affiliation': 'Department of Neurosciences, Dentistry Section, University of Padova, Padova, Italy.'}, {'ForeName': 'Daniele', 'Initials': 'D', 'LastName': 'Botticelli', 'Affiliation': 'ARDEC Academy, Ariminum Odontologica SRL, Rimini, Italy.'}, {'ForeName': 'Sanjana', 'Initials': 'S', 'LastName': 'Prasad', 'Affiliation': 'Hard Tissue Research Laboratory, Biological and Diagnostic Sciences, School of Dentistry, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Ricci', 'Affiliation': 'Department of Neurosciences, Dentistry Section, University of Padova, Padova, Italy.'}, {'ForeName': 'Eriberto', 'Initials': 'E', 'LastName': 'Bressan', 'Affiliation': 'Department of Neurosciences, Dentistry Section, University of Padova, Padova, Italy.'}, {'ForeName': 'Hari', 'Initials': 'H', 'LastName': 'Prasad', 'Affiliation': 'Hard Tissue Research Laboratory, Biological and Diagnostic Sciences, School of Dentistry, University of Minnesota, Minneapolis, MN, USA.'}]",Clinical oral implants research,['10.1111/clr.13626'] 1850,32552850,Intense and unpredictable perturbations during gait training improve dynamic balance abilities in chronic hemiparetic individuals: a randomized controlled pilot trial.,"BACKGROUND Previous studies have assessed the effects of perturbation training on balance after stroke. However, the perturbations were either applied while standing or were small in amplitude during gait, which is not representative of the most common fall conditions. The perturbations were also combined with other challenges such as progressive increases in treadmill speed. OBJECTIVE To determine the benefit of treadmill training with intense and unpredictable perturbations compared to treadmill walking-only training for dynamic balance and gait post-stroke. METHODS Twenty-one individuals post-stroke with reduced dynamic balance abilities, with or without a history of fall and ability to walk on a treadmill without external support or a walking aid for at least 1 min were allocated to either an unpredictable gait perturbation (Perturb) group or a walking-only (NonPerturb) group through covariate adaptive randomization. Nine training sessions were conducted over 3 weeks. NonPerturb participants only walked on the treadmill but were offered perturbation training after the control intervention. Pre- and post-training evaluations included balance and gait abilities, maximal knee strength, balance confidence and community integration. Six-week phone follow-ups were conducted for balance confidence and community integration. Satisfaction with perturbation training was also assessed. RESULTS With no baseline differences between groups (p > 0.075), perturbation training yielded large improvements in most variables in the Perturb (p < 0.05, Effect Size: ES > .46) group (n = 10) and the NonPerturb (p ≤ .089, ES > .45) group (n = 7 post-crossing), except for maximal strength (p > .23) in the NonPerturb group. Walking-only training in the NonPerturb group (n = 8, pre-crossing) mostly had no effect (p > .292, ES < .26), except on balance confidence (p = .063, ES = .46). The effects of the gait training were still present on balance confidence and community integration at follow-up. Satisfaction with the training program was high. CONCLUSION Intense and unpredictable gait perturbations have the potential to be an efficient component of training to improve balance abilities and community integration in individuals with chronic stroke. Retrospective registration: ClinicalTrials.gov. March 18th, 2020. Identifier: NCT04314830.",2020,", perturbation training yielded large improvements in most variables in the Perturb (p < 0.05, Effect Size: ES > .46) group (n = 10) and the NonPerturb (p ≤ .089, ES > .45) group (n = 7 post-crossing), except for maximal strength (p > .23) in the NonPerturb group.","['Twenty-one individuals post-stroke with reduced dynamic balance abilities, with or without a history of fall and ability to walk on a treadmill without external support or a walking aid for at least 1\u2009min', 'chronic hemiparetic individuals', 'individuals with chronic stroke']","['gait training', 'treadmill training with intense and unpredictable perturbations compared to treadmill walking-only training', 'unpredictable gait perturbation (Perturb) group or a walking-only (NonPerturb) group through covariate adaptive randomization', 'perturbation training']","['balance and gait abilities, maximal knee strength, balance confidence and community integration', 'dynamic balance abilities', 'balance confidence', 'maximal strength', 'progressive increases in treadmill speed', 'balance confidence and community integration']","[{'cui': 'C3715213', 'cui_str': '21'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0560184', 'cui_str': 'Ability to balance'}, {'cui': 'C1561668', 'cui_str': 'History of fall'}, {'cui': 'C0559964', 'cui_str': 'Ability to walk'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C3536593', 'cui_str': 'Chronic cerebrovascular accident'}]","[{'cui': 'C0085673', 'cui_str': 'Gait training procedure'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0332453', 'cui_str': 'Disruption'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}]","[{'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C3494302', 'cui_str': 'Community Integration'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0560184', 'cui_str': 'Ability to balance'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}]",,0.0445433,", perturbation training yielded large improvements in most variables in the Perturb (p < 0.05, Effect Size: ES > .46) group (n = 10) and the NonPerturb (p ≤ .089, ES > .45) group (n = 7 post-crossing), except for maximal strength (p > .23) in the NonPerturb group.","[{'ForeName': 'Vahid', 'Initials': 'V', 'LastName': 'Esmaeili', 'Affiliation': 'School of Rehabilitation, Université de Montréal, P.O. Box 6128, Station Centre-Ville, Montreal, Quebec, H3C 3J7, Canada.'}, {'ForeName': 'Andréanne', 'Initials': 'A', 'LastName': 'Juneau', 'Affiliation': ""Centre for Interdisciplinary Research in Rehabilitation-Institut Universitaire sur la Réadaptation en Déficience Physique de Montréal, in CIUSSS du Centre-Sud-de-l'ile-de-Montréal, Montreal, Canada.""}, {'ForeName': 'Joseph-Omer', 'Initials': 'JO', 'LastName': 'Dyer', 'Affiliation': 'School of Rehabilitation, Université de Montréal, P.O. Box 6128, Station Centre-Ville, Montreal, Quebec, H3C 3J7, Canada.'}, {'ForeName': 'Anouk', 'Initials': 'A', 'LastName': 'Lamontagne', 'Affiliation': ""Centre for Interdisciplinary Research in Rehabilitation-Institut Universitaire sur la Réadaptation en Déficience Physique de Montréal, in CIUSSS du Centre-Sud-de-l'ile-de-Montréal, Montreal, Canada.""}, {'ForeName': 'Dahlia', 'Initials': 'D', 'LastName': 'Kairy', 'Affiliation': 'School of Rehabilitation, Université de Montréal, P.O. Box 6128, Station Centre-Ville, Montreal, Quebec, H3C 3J7, Canada.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Bouyer', 'Affiliation': 'Department of Rehabilitation, Faculty of Medicine, Université Laval and Center for Interdisciplinary Research in Rehabilitation and Social Integration, CIUSSS-CN, Quebec City, Canada.'}, {'ForeName': 'Cyril', 'Initials': 'C', 'LastName': 'Duclos', 'Affiliation': 'School of Rehabilitation, Université de Montréal, P.O. Box 6128, Station Centre-Ville, Montreal, Quebec, H3C 3J7, Canada. cyril.duclos@umontreal.ca.'}]",Journal of neuroengineering and rehabilitation,['10.1186/s12984-020-00707-0'] 1851,32553642,Love at first taste: Activation in reward-related brain regions during single-trial naturalistic appetitive conditioning in humans.,"Palatable food can trigger appetitive responses, such as salivation and approach tendencies. Though evolutionarily functional, these conditioned responses can encourage overeating and obesity when food is abundant. The current study examines the neural correlates of 'denovo' Pavlovian appetitive conditioning, pairing one class of unknown objects (conditioned stimuli, CS) with their sweet taste (unconditioned stimulus, US) during a single trial. To do so, 23 participants consumed unknown (marzipan) objects of one particular color (CS+) while only interacting with control stimuli of different color and shape (CS-). After this single-trial conditioning procedure, participants viewed and rated images of the marzipan figures and the control objects during functional magnetic resonance imaging (fMRI). Relative to the CS-, the CS+ elicited stronger activation in the dorsal striatum, a brain region associated with cue-reward coupling. Furthermore, conditioning effects in subjective 'craving', defined as increased palatability and desire to eat, were observed, and these were positively related to conditioning effects in the amygdala, a brain region associated with the need-dependent value of a reward. Thus, the study identified reward-related brain regions involved in single-trial appetitive learning, thereby providing a potential mechanism that contributes to the etiology of food craving. These findings might help to understand clinically relevant food cravings in individuals with eating or weight related concerns and might support the development of extinction based treatments.",2020,"Relative to the CS-, the CS+ elicited stronger activation in the dorsal striatum, a brain region associated with cue-reward coupling.","['23 participants consumed unknown (marzipan) objects of one particular color (CS+) while only interacting with control stimuli of different color and shape (CS', 'humans']","[""denovo' Pavlovian appetitive conditioning, pairing one class of unknown objects (conditioned stimuli, CS) with their sweet taste (unconditioned stimulus, US""]","[""subjective 'craving"", 'palatability and desire to eat']","[{'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C0347997', 'cui_str': 'Physical object'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C0332479', 'cui_str': 'Shape finding'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}]","[{'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C0347997', 'cui_str': 'Physical object'}, {'cui': 'C0234404', 'cui_str': 'Conditioned stimulus'}, {'cui': 'C0858600', 'cui_str': 'Taste sweet'}, {'cui': 'C0234403', 'cui_str': 'Unconditioned stimulus'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}]",23.0,0.0298472,"Relative to the CS-, the CS+ elicited stronger activation in the dorsal striatum, a brain region associated with cue-reward coupling.","[{'ForeName': 'Lender', 'Initials': 'L', 'LastName': 'A', 'Affiliation': 'Department of Psychology, Centre for Cognitive Neuroscience, Paris-Lodron-University of Salzburg, Hellbrunner Str. 34, 5020 Salzburg, Austria. Electronic address: anja.lender@sbg.ac.at.'}, {'ForeName': 'Miedl', 'Initials': 'M', 'LastName': 'Sf', 'Affiliation': 'Department of Psychology, Division of Clinical Psychology and Psychopathology, Paris-Lodron-University of Salzburg, Hellbrunner Str. 34, 15020 Salzburg, Austria.'}, {'ForeName': 'Wilhelm', 'Initials': 'W', 'LastName': 'Fh', 'Affiliation': 'Department of Psychology, Division of Clinical Psychology and Psychopathology, Paris-Lodron-University of Salzburg, Hellbrunner Str. 34, 15020 Salzburg, Austria.'}, {'ForeName': 'Miller', 'Initials': 'M', 'LastName': 'J', 'Affiliation': 'Department of Psychology, Centre for Cognitive Neuroscience, Paris-Lodron-University of Salzburg, Hellbrunner Str. 34, 5020 Salzburg, Austria.'}, {'ForeName': 'Blechert', 'Initials': 'B', 'LastName': 'J', 'Affiliation': 'Department of Psychology, Centre for Cognitive Neuroscience, Paris-Lodron-University of Salzburg, Hellbrunner Str. 34, 5020 Salzburg, Austria.'}]",Physiology & behavior,['10.1016/j.physbeh.2020.113014'] 1852,32553717,Plasma Pharmacokinetics and Urinary Excretion of Tenofovir Following Cessation in Adults with Controlled Levels of Adherence to Tenofovir Disoproxil Fumarate.,"OBJECTIVES To fully characterize the plasma and urine washout pharmacokinetics of TFV in adults following 6 weeks of controlled levels of TDF adherence to inform the utility of clinic-based adherence testing. DESIGN A 3-arm randomized, open-label study in adult volunteers. Participants were randomized to receive TDF 300 mg/emtricitabine (FTC) 200 mg either: (i) 7 doses/week (Perfect Adherence), (ii) 4 doses/week (Moderate Adherence), or (iii) 2 doses/week (Low Adherence). Plasma and urine samples were regularly collected during the six-week dosing phase and four weeks following drug cessation. RESULTS Twenty-eight adults were included in this analysis. Median (range) age was 33 (20-49) years. No differences in TFV PK parameters during the washout were observed across arms. Small differences in TFV plasma concentrations occurred across arms between 4 to 10 hours post-dose. The cumulative amount of TFV excreted in urine was not different 24 hours post-dose, but at 148 hours was 24.8, 21.0 and 17.2 mg for the Perfect, Moderate and Low Adherence arms, respectively (p = 0.043). CONCLUSIONS Among adults with different TDF adherence patterns, relative differences in plasma concentrations and cumulative urine extraction of TFV were minor following cessation. TFV measurement in plasma or urine is more indicative of last drug ingestion rather than differentiating recent adherence patterns.",2020,"The cumulative amount of TFV excreted in urine was not different 24 hours post-dose, but at 148 hours was 24.8, 21.0 and 17.2 mg for the Perfect, Moderate and Low Adherence arms, respectively (p = 0.043). ","['Adults with Controlled Levels of Adherence to', 'adult volunteers', 'adults with different TDF adherence patterns', 'Median (range) age was 33 (20-49) years', 'Twenty-eight adults']","['Tenofovir Disoproxil Fumarate', 'TDF 300\u2009mg/emtricitabine (FTC']","['Plasma and urine samples', 'cumulative amount of TFV excreted in urine', 'TFV PK parameters', 'Plasma Pharmacokinetics and Urinary Excretion of Tenofovir', 'plasma concentrations and cumulative urine extraction of TFV', 'TFV measurement in plasma or urine', 'TFV plasma concentrations']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C1099776', 'cui_str': 'Tenofovir disoproxil fumarate'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0619283', 'cui_str': 'IS 33'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4283787', 'cui_str': '28'}]","[{'cui': 'C1099776', 'cui_str': 'Tenofovir disoproxil fumarate'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0909839', 'cui_str': 'emtricitabine'}, {'cui': 'C0206682', 'cui_str': 'Follicular thyroid carcinoma'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C1610733', 'cui_str': 'Urine specimen'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0384228', 'cui_str': 'Tenofovir'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}]",28.0,0.0747984,"The cumulative amount of TFV excreted in urine was not different 24 hours post-dose, but at 148 hours was 24.8, 21.0 and 17.2 mg for the Perfect, Moderate and Low Adherence arms, respectively (p = 0.043). ","[{'ForeName': 'Tim R', 'Initials': 'TR', 'LastName': 'Cressey', 'Affiliation': 'PHPT/IRD, Faculty of Associated Medical Sciences, Chiang Mai University, Chiang Mai, Thailand; Department of Immunology & Infectious Diseases, Boston, Harvard T.H Chan School of Public Health, MA, USA; Department of Molecular & Clinical Pharmacology, University of Liverpool, UK. Electronic address: tim.cressey@phpt.org.'}, {'ForeName': 'Oraphan', 'Initials': 'O', 'LastName': 'Siriprakaisil', 'Affiliation': 'Sanpatong Hospital, Chiang Mai, Thailand.'}, {'ForeName': 'Rachel W', 'Initials': 'RW', 'LastName': 'Kubiak', 'Affiliation': 'Department of Epidemiology, University of Washington, Seattle, USA.'}, {'ForeName': 'Virat', 'Initials': 'V', 'LastName': 'Klinbuayaem', 'Affiliation': 'Sanpatong Hospital, Chiang Mai, Thailand.'}, {'ForeName': 'Pra-Ornsuda', 'Initials': 'PO', 'LastName': 'Sukrakanchana', 'Affiliation': 'PHPT/IRD, Faculty of Associated Medical Sciences, Chiang Mai University, Chiang Mai, Thailand.'}, {'ForeName': 'Justice', 'Initials': 'J', 'LastName': 'Quame-Amaglo', 'Affiliation': 'Department of Global Health, University of Washington, Seattle, USA.'}, {'ForeName': 'Hideaki', 'Initials': 'H', 'LastName': 'Okochi', 'Affiliation': 'Department of Medicine, University of California-San Francisco (UCSF), San Francisco, USA.'}, {'ForeName': 'Yardpiroon', 'Initials': 'Y', 'LastName': 'Tawon', 'Affiliation': 'PHPT/IRD, Faculty of Associated Medical Sciences, Chiang Mai University, Chiang Mai, Thailand.'}, {'ForeName': 'Ratchada', 'Initials': 'R', 'LastName': 'Cressey', 'Affiliation': 'Department of Medical Technology, Faculty of Associated Medical Sciences, Chiang Mai University, Thailand.'}, {'ForeName': 'Jared M', 'Initials': 'JM', 'LastName': 'Baeten', 'Affiliation': 'Department of Epidemiology, University of Washington, Seattle, USA; Department of Global Health, University of Washington, Seattle, USA; Department of Medicine, University of Washington, Seattle, USA.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Gandhi', 'Affiliation': 'Department of Medicine, University of California-San Francisco (UCSF), San Francisco, USA.'}, {'ForeName': 'Paul K', 'Initials': 'PK', 'LastName': 'Drain', 'Affiliation': 'Department of Epidemiology, University of Washington, Seattle, USA; Department of Global Health, University of Washington, Seattle, USA; Department of Medicine, University of Washington, Seattle, USA.'}]",International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases,['10.1016/j.ijid.2020.06.037'] 1853,32553888,Effect of practical hyperoxic high-intensity interval training on exercise performance.,"This study investigated the effect of a practical hyperoxic high-intensity interval training (HIIT) on aerobic and anaerobic exercise capacity. Sixteen male athletes were randomized into 2 groups: normoxic HIIT (NHIIT, n = 8) group or hyperoxic HIIT (HHIIT, n = 8) group and trained for 3 weeks (2 days/week) on a cycle ergometer (2-min intervals, with 2-min rest between intervals) at maximal workload, which was obtained during a maximal graded exercise test under normoxia. All training sessions were performed until exhaustion. Participants performed maximal graded exercise, submaximal exercise, and 90-s maximal exercise tests before and after the training period. Maximal oxygen uptake (P < 0.01) increased significantly in both groups. Blood lactate curve during submaximal exercise improved significantly only in the HHIIT group (P < 0.01). Mean power output during maximal exercise increased significantly only in the HHIIT group (P = 0.02). This study demonstrated that a practical hyperoxic HHIIT might be effective for improving aerobic capacity and anaerobic performance.",2020,Blood lactate curve during submaximal exercise improved significantly only in the HHIIT group (P <  0.01).,['Sixteen male athletes'],"['normoxic HIIT (NHIIT, n\u2009=\u20098) group or hyperoxic HIIT (HHIIT, n\u2009=\u20098) group and trained for 3 weeks (2 days/week) on a cycle ergometer (2-min intervals, with 2-min rest between intervals) at maximal workload, which was obtained during a maximal graded exercise test under normoxia', 'maximal graded exercise, submaximal exercise, and 90-s maximal exercise tests', 'practical hyperoxic high-intensity interval training', 'practical hyperoxic high-intensity interval training (HIIT']","['Mean power output during maximal exercise', 'Blood lactate curve during submaximal exercise', 'Maximal oxygen uptake', 'aerobic capacity and anaerobic performance', 'aerobic and anaerobic exercise capacity', 'exercise performance']","[{'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}]","[{'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0677547', 'cui_str': 'days/week'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0085122', 'cui_str': 'Work Load'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0445194', 'cui_str': 'Power output'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}]",16.0,0.0253253,Blood lactate curve during submaximal exercise improved significantly only in the HHIIT group (P <  0.01).,"[{'ForeName': 'Michihiro', 'Initials': 'M', 'LastName': 'Kon', 'Affiliation': 'School of International Liberal Studies, Chukyo University, 101-2 Yagotohonmachi, Showa-ku, Nagoya, 466-8666, Japan; Department of Sports Sciences, Japan Institute of Sports Sciences, 3-15-1 Nishigaoka, Kita-ku, Tokyo, 115-0056, Japan. Electronic address: kon.michihiro@gmail.com.'}, {'ForeName': 'Kohei', 'Initials': 'K', 'LastName': 'Nakagaki', 'Affiliation': 'Department of Sports Sciences, Japan Institute of Sports Sciences, 3-15-1 Nishigaoka, Kita-ku, Tokyo, 115-0056, Japan; Department of Sports Sciences, Yamanashi Gakuin University, 2-4-5 Sakaori, Kofu, Yamanashi, 400-8575, Japan.'}, {'ForeName': 'Yoshiko', 'Initials': 'Y', 'LastName': 'Ebi', 'Affiliation': 'Department of Sports Sciences, Japan Institute of Sports Sciences, 3-15-1 Nishigaoka, Kita-ku, Tokyo, 115-0056, Japan.'}]",Respiratory physiology & neurobiology,['10.1016/j.resp.2020.103481'] 1854,32553922,Conditioning automatic inhibition task: Introducing a novel task to associate automatic inhibition with specific cues.,"There is growing interest in methods for conditioning automatic inhibition with specific stimuli and the potential clinical implications of these methods. For example, OCD patients were shown to benefit from a computerized training program which aimed to create an association between OCD-related cues and stopping behaviors. In the current study, we aimed to investigate the ability to condition inhibition to specific stimuli and whether such conditioning can be generalized between tasks to last over time. Participants completed 6 training sessions using a novel version of the stop-signal task, the 'conditioning automatic inhibition task' (CAIT), over a 48 -h period, in which one randomly chosen color patch was associated with inhibition. The classic Stroop task was administered before and after the CAIT training. Results yielded smaller congruency and interference effects in the Stroop task after training, but only for the color that was associated with stopping. These results demonstrate the effect of the CAIT onto one specific stimulus, and that the effect generalized between the training and testing tasks. This provides novel evidence that the CAIT can be used to facilitate faster recruitment of inhibitory resources for a specific trained stimulus, which might later help resolve cognitive conflicts that require inhibition and might also have important clinical implications.",2020,"Results yielded smaller congruency and interference effects in the Stroop task after training, but only for the color that was associated with stopping.",[],"['Conditioning Automatic Inhibition Task', ""training sessions using a novel version of the stop-signal task, the 'conditioning automatic inhibition task' (CAIT""]",['smaller congruency and interference effects'],[],"[{'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0450446', 'cui_str': 'Stops'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}]","[{'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",1.0,0.0185002,"Results yielded smaller congruency and interference effects in the Stroop task after training, but only for the color that was associated with stopping.","[{'ForeName': 'Shachar', 'Initials': 'S', 'LastName': 'Hochman', 'Affiliation': 'Department of Psychology and the Zlotowski Center for Neuroscience, Ben-Gurion University of the Negev, Beer-Sheva, Israel; Department of Psychology, The Hebrew University of Jerusalem, Israel. Electronic address: shacharh@post.bgu.ac.il.'}, {'ForeName': 'Shahaf', 'Initials': 'S', 'LastName': 'Leshem', 'Affiliation': 'Department of Psychology, The Hebrew University of Jerusalem, Israel.'}, {'ForeName': 'Avishai', 'Initials': 'A', 'LastName': 'Henik', 'Affiliation': 'Department of Psychology and the Zlotowski Center for Neuroscience, Ben-Gurion University of the Negev, Beer-Sheva, Israel.'}, {'ForeName': 'Eyal', 'Initials': 'E', 'LastName': 'Kalanthroff', 'Affiliation': 'Department of Psychology, The Hebrew University of Jerusalem, Israel.'}]",Journal of neuroscience methods,['10.1016/j.jneumeth.2020.108809'] 1855,32553932,The Second Strategic Reperfusion Early After Myocardial Infarction (STREAM-2) study optimizing pharmacoinvasive reperfusion strategy in older ST-elevation myocardial infarction patients.,"BACKGROUND The STREAM study demonstrated that a pharmaco-invasive strategy was at least as effective as primary PCI (pPCI) in patients presenting early with ST-elevation myocardial infarction (STEMI). The current trial is a response to the finding that reduced intracranial hemorrhage (ICH) in patients ≥75 years occurred after halving the dose of tenecteplase. Additionally, a subsequent analysis of full dose tenecteplase or alteplase in the Assessment of the Safety and Efficacy of a New Thrombolytic (ASSENT) trials demonstrated a steep increase in bleeding events beginning around the age of 60 years. METHODS STREAM-2 will compare the efficacy and safety of a novel pharmaco-invasive strategy as compared to routine pPCI in STEMI patients ≥60 years presenting within 3 hours from symptom onset. In the pharmaco-invasive arm patients will receive half-dose tenecteplase, as soon as possible before transport to a PCI center. In the pPCI arm, patients will be treated according to optimal standard of care defined by local practice. The key criteria for efficacy will be the number of patients achieving ≥50% ST-segment resolution before and after PCI in lead with maximal ST elevation at baseline and the clinical endpoints of death, congestive heart failure, shock or re-infarction, rescue PCI and aborted myocardial infarction, both singularly and as a composite at 30 days. Key safety criteria are total stroke, ICH and major non-intracranial bleeds. Approximately 600 patients will be randomized (400 to pharmaco-invasive treatment and 200 to pPCI). An interim analysis is planned after 300 patients are enrolled to consider adapting the trial to include a larger sample size aimed at undertaking a formal confirmatory trial. DISCUSSION The study will provide new insights aimed at establishing an effective and safer pharmaco-invasive treatment for the growing population of older STEMI patients who cannot undergo timely pPCI.",2020,The current trial is a response to the finding that reduced intracranial hemorrhage (ICH) in patients ≥75 years occurred after halving the dose of tenecteplase.,"['older STEMI patients who cannot undergo timely pPCI', '300 patients', 'older ST-elevation myocardial infarction patients', 'Approximately 600 patients', 'STEMI patients ≥60 years presenting within 3 hours from symptom onset', 'patients presenting early with ST-elevation myocardial infarction (STEMI']",['novel pharmaco-invasive strategy'],"['intracranial hemorrhage (ICH', 'bleeding events', 'efficacy and safety']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C1303258', 'cui_str': 'Acute ST segment elevation myocardial infarction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C1279919', 'cui_str': 'Early'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}]","[{'cui': 'C0151699', 'cui_str': 'Intracranial hemorrhage'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",600.0,0.0767294,The current trial is a response to the finding that reduced intracranial hemorrhage (ICH) in patients ≥75 years occurred after halving the dose of tenecteplase.,"[{'ForeName': 'Paul W', 'Initials': 'PW', 'LastName': 'Armstrong', 'Affiliation': 'The Canadian Virtual Coordinating Centre for Global Collaborative Cardiovascular Research {Canadian VIGOUR Centre}, University of Alberta, Edmonton, Canada.'}, {'ForeName': 'Kris', 'Initials': 'K', 'LastName': 'Bogaerts', 'Affiliation': 'Interuniversity Institute for Biostatistics and statistical Bioinformatics (I-BioStat), KU Leuven, Leuven and University Hasselt, Hasselt, Belgium.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Welsh', 'Affiliation': 'The Canadian Virtual Coordinating Centre for Global Collaborative Cardiovascular Research {Canadian VIGOUR Centre}, University of Alberta, Edmonton, Canada.'}, {'ForeName': 'Peter R', 'Initials': 'PR', 'LastName': 'Sinnaeve', 'Affiliation': 'Dept. of Cardiovascular Sciences, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Goldstein', 'Affiliation': 'Emergency Department and SAMU, Lille University Hospital, Lille, France.'}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Pages', 'Affiliation': 'Boehringer Ingelheim GmbH, Ingelheim am Rhein, Germany.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Danays', 'Affiliation': 'TDC, Aix en Provence, France.'}, {'ForeName': 'Frans', 'Initials': 'F', 'LastName': 'Van de Werf', 'Affiliation': 'Dept. of Cardiovascular Sciences, KU Leuven, Leuven, Belgium. Electronic address: frans.vandewerf@kuleuven.be.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American heart journal,['10.1016/j.ahj.2020.04.029'] 1856,32555211,The effects of environmental enrichment on skin barrier recovery in humans: a randomised trial.,"This study investigated whether environmental enrichment (EE) could reduce stress and improve wound healing in humans. 120 participants underwent a standardised tape-stripping procedure and were then randomised to interact for 30 minutes with one of three EE interventions (comfort blankets as tactile enrichment, music as auditory enrichment or a Paro robot as multi-sensory enrichment) or to a control group. Skin barrier recovery (SBR) was measured using transepidermal water loss at baseline, after tape-stripping and after the intervention. Psychological variables, cortisol and alpha-amylase were measured at the three time-points. SBR did not significantly differ between the EE conditions and the control condition. The music condition had higher stimulation levels than the control condition, and the comfort condition had significantly lower relaxation levels than the control condition after the intervention. The EE interventions tested were not beneficial for wound healing compared to a control group. Limitations were that the sample were not stressed and an active control condition was used.",2020,SBR did not significantly differ between the EE conditions and the control condition.,"['120 participants underwent a', 'humans']","['environmental enrichment (EE', 'standardised tape-stripping procedure', 'environmental enrichment', 'EE interventions (comfort blankets as tactile enrichment, music as auditory enrichment or a Paro robot as multi-sensory enrichment) or to a control group']","['stimulation levels', 'SBR', 'skin barrier recovery', 'Skin barrier recovery (SBR', 'wound healing', 'relaxation levels', 'Psychological variables, cortisol and alpha-amylase']","[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}]","[{'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0343138', 'cui_str': 'Strapping procedure'}, {'cui': 'C0185047', 'cui_str': 'Stripping'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0179330', 'cui_str': 'Blanket'}, {'cui': 'C0439815', 'cui_str': 'Tactile'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0002245', 'cui_str': 'alpha-Amylase'}]",120.0,0.0391175,SBR did not significantly differ between the EE conditions and the control condition.,"[{'ForeName': 'Mikaela', 'Initials': 'M', 'LastName': 'Law', 'Affiliation': 'Department of Psychological Medicine, University of Auckland, Private Bag 92019, Auckland, 1142, New Zealand.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Jarrett', 'Affiliation': 'Department of Dermatology, Middlemore Hospital, Auckland, New Zealand.'}, {'ForeName': 'Urs M', 'Initials': 'UM', 'LastName': 'Nater', 'Affiliation': 'Faculty of Psychology, University of Vienna, Vienna, 1010, Austria.'}, {'ForeName': 'Nadine', 'Initials': 'N', 'LastName': 'Skoluda', 'Affiliation': 'Faculty of Psychology, University of Vienna, Vienna, 1010, Austria.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Broadbent', 'Affiliation': 'Department of Psychological Medicine, University of Auckland, Private Bag 92019, Auckland, 1142, New Zealand. e.broadbent@auckland.ac.nz.'}]",Scientific reports,['10.1038/s41598-020-66687-2'] 1857,32559181,Effect of Parenting Training on Neurobehavioral Development of Infants.,"BACKGROUND Early interventions have been believed to have a positive influence on the neurodevelopment of infants. Our Child Health Center has carried out parenting training for parents of infants for several years to promote the neurobehavioral development of infants at an early stage. MATERIAL AND METHODS We enrolled 117 families with term infants age 0-3 months who had completed a parenting training class at the Child Health Center of the Department of Pediatrics, the Third Xiangya Hospital. Parenting training included 4 parts: nursing, intelligence, social contact, and physical ability. A nurse practitioner demonstrated procedures to parents, who then performed them at home for 1 month. The Neonatal Behavioral Neurological Assessment (NBNA) was used to evaluate infants before and 1 month after parenting training. RESULTS In the comparative analysis before and after parenting training, there was a significant increase in the NBNA scores. For the infants whose parents received parenting training, the NBNA scores in total score (33.74±0.19 before parenting training vs. 36.69±0.20 after 1 month), neonatal behavioral capacity (10.19±0.14 before parenting training vs. 11.26±0.10 after 1 month), passive muscle tension (7.28±0.07 before parenting training vs. 7.82±0.04 after 1 month), and initiative muscle tension (4.29±0.08 before the parenting training vs. 5.61±0.13 after 1 month) were significantly higher one month before (P<0.01). CONCLUSIONS Term infant neurobehavior was associated with participation in parenting training, suggesting that these practices of parenting training support better early neurobehavioral development of infants.",2020,"In the comparative analysis before and after parenting training, there was a significant increase in the NBNA scores.","['Infants', '117 families with term infants age 0-3 months who had completed a parenting training class at the Child Health Center of the Department of Pediatrics, the Third Xiangya Hospital']","['Parenting Training', 'parenting training']","['NBNA scores in total score', 'NBNA scores', 'passive muscle tension', 'neonatal behavioral capacity', 'Neonatal Behavioral Neurological Assessment (NBNA', 'initiative muscle tension']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0456128', 'cui_str': 'Term infant'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0008078', 'cui_str': 'Child health care'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0027853', 'cui_str': 'Neurological examination'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0026841', 'cui_str': 'Muscle Tension'}, {'cui': 'C0424093', 'cui_str': 'Initiative'}]",117.0,0.0160345,"In the comparative analysis before and after parenting training, there was a significant increase in the NBNA scores.","[{'ForeName': 'Mei', 'Initials': 'M', 'LastName': 'Jiang', 'Affiliation': 'Department of Pediatrics, The Third Xiangya Hospital, Central South University, Changsha, Hunan, China (mainland).'}, {'ForeName': 'Quyan', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': 'Department of Pediatrics, The Third Xiangya Hospital, Central South University, Changsha, Hunan, China (mainland).'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': 'Department of Pediatrics, The Third Xiangya Hospital, Central South University, Changsha, Hunan, China (mainland).'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'He', 'Affiliation': 'Department of Pediatrics, The Third Xiangya Hospital, Central South University, Changsha, Hunan, China (mainland).'}, {'ForeName': 'Ke', 'Initials': 'K', 'LastName': 'Huang', 'Affiliation': 'Department of Pediatrics, The Third Xiangya Hospital, Central South University, Changsha, Hunan, China (mainland).'}, {'ForeName': 'Guo', 'Initials': 'G', 'LastName': 'Peng', 'Affiliation': 'Department of Pediatrics, The Third Xiangya Hospital, Central South University, Changsha, Hunan, China (mainland).'}, {'ForeName': 'Jinhui', 'Initials': 'J', 'LastName': 'Huang', 'Affiliation': 'Department of Pediatrics, The Third Xiangya Hospital, Central South University, Changsha, Hunan, China (mainland).'}, {'ForeName': 'Mingyi', 'Initials': 'M', 'LastName': 'Zhao', 'Affiliation': 'Department of Pediatrics, The Third Xiangya Hospital, Central South University, Changsha, Hunan, China (mainland).'}]",Medical science monitor : international medical journal of experimental and clinical research,['10.12659/MSM.924457'] 1858,31961711,Effects of combined histamine H 1 and H 2 receptor blockade on hemodynamic responses to dynamic exercise in males with high-normal blood pressure.,"While postexercise hypotension is associated with histamine H 1 and H 2 receptor-mediated postexercise vasodilation, effects of histaminergic vasodilation on blood pressure (BP) in response to dynamic exercise are not known. Thus, in 20 recreationally active male participants (10 normotensive and 10 with high-normal BP) we examined the effects of histamine H 1 and H 2 receptor blockade on cardiac output (CO), mean atrial pressure (MAP), aortic stiffness (AoStiff), and total vascular conductance (TVC) at rest and during progressive cycling exercise. Compared with the normotensive group, MAP, CO, and AoStiff were higher in the high-normal group before and after the blockade at rest, while TVC was similar. At the 40% workload, the blockade significantly increased MAP in both groups, while no difference was found in the TVC. CO was higher in the high-normal group than the normotensive group in both conditions. At the 60% workload, the blockade substantially increased MAP and decreased TVC in the normotensive group, while there were no changes in the high-normal group. A similar CO response pattern was observed at the 60% workload. These findings suggest that the mechanism eliciting an exaggerated BP response to exercise in the high-normal group may be partially due to the inability of histamine receptors. Novelty Males with high-normal BP had an exaggerated BP response to exercise. The overactive BP response is known due to an increase in peripheral vasoconstriction. Increase in peripheral vasoconstriction is partially due to inability of histamine receptors.",2020,"At the 40% workload, the blockade significantly increased MAP in both groups, while no difference was found in the TVC.","['males with high-normal blood pressure', '20 recreationally active male participants (10 normotensive and 10 with high-normal BP', 'Males with high-normal BP']","['histamine H 1 and H 2 receptor blockade', 'combined histamine H 1 and H 2 receptor blockade']","['cardiac output (CO), mean atrial pressure (MAP), aortic stiffness (AoStiff), and total vascular conductance (TVC) at rest and during progressive cycling exercise', 'exaggerated BP response', 'MAP, CO, and AoStiff', 'TVC', 'MAP', 'blood pressure (BP', 'Novelty', 'CO', 'CO response pattern', 'MAP and decreased TVC', 'overactive BP response']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C2712122', 'cui_str': 'Normal blood pressure'}, {'cui': 'C0205177', 'cui_str': 'Active'}]","[{'cui': 'C0019588', 'cui_str': 'Histamine'}, {'cui': 'C0700308', 'cui_str': 'Protium'}, {'cui': 'C0011744', 'cui_str': 'Deuterium'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C0332206', 'cui_str': 'Blocking'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0007165', 'cui_str': 'Cardiac output'}, {'cui': 'C3854604', 'cui_str': 'Mean atrial pressure'}, {'cui': 'C3178782', 'cui_str': 'Aortic Stiffness'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0443144', 'cui_str': 'At rest'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0442801', 'cui_str': 'Exaggerated'}, {'cui': 'C0024779', 'cui_str': 'Maps'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0443272', 'cui_str': 'Overactive'}]",10.0,0.0443588,"At the 40% workload, the blockade significantly increased MAP in both groups, while no difference was found in the TVC.","[{'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Naylor', 'Affiliation': 'Department of Kinesiology, California Baptist University, Riverside, CA 92504, USA.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Shariffi', 'Affiliation': 'Department of Kinesiology, California Baptist University, Riverside, CA 92504, USA.'}, {'ForeName': 'Trevor L', 'Initials': 'TL', 'LastName': 'Gillum', 'Affiliation': 'Department of Kinesiology, California Baptist University, Riverside, CA 92504, USA.'}, {'ForeName': 'Boyer', 'Initials': 'B', 'LastName': 'William', 'Affiliation': 'Department of Kinesiology, California Baptist University, Riverside, CA 92504, USA.'}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'Sullivan', 'Affiliation': 'Department of Kinesiology, California Baptist University, Riverside, CA 92504, USA.'}, {'ForeName': 'Jong-Kyung', 'Initials': 'JK', 'LastName': 'Kim', 'Affiliation': 'Department of Kinesiology, California Baptist University, Riverside, CA 92504, USA.'}]","Applied physiology, nutrition, and metabolism = Physiologie appliquee, nutrition et metabolisme",['10.1139/apnm-2019-0645'] 1859,32566130,Toward a paradigm shift from deficit-based to proactive speech and language treatment: Randomized pilot trial of the Babble Boot Camp in infants with classic galactosemia.,"Background: Speech and language therapy is typically initiated reactively after a child shows delays. Infants with classic galactosemia (CG), a metabolic disease with a known high risk for both speech and language disorders, hold the keys towards evaluating whether preventive treatment is effective when the risks are known at birth. We present pilot data from a randomized parallel trial of an innovative proactive speech and language intervention program, the Babble Boot Camp (BBC).  Method : Five children with CG, otherwise healthy, participated in the study from approximately 2 to 24 months of age. One of these was randomly selected as control receiving conventional management, which typically starts at age 2-3 years. A pediatric speech-language pathologist met weekly via telepractice with the parents in the treatment cohort. Parents implemented the prespeech, speech, and language stimulation and expansion activities according to the intervention protocol. The control child was still too young for conventional treatment. Primary outcome measures were speech sound production complexity in babble and speech and expressive vocabulary size. Secondary outcome measures were vocalization rates and developmental milestones in communication, motor, and cognition. The trial is ongoing. Results :  All four treated children had higher speech sound skills in babble, three had higher speech sound skills in meaningful speech, two had higher expressive vocabularies, three had higher global developmental scores, and two had higher vocalization rates, compared to the control child with CG. Discussion: Given the high risk for speech and language delays in children with CG, finding on-schedule abilities in two or more of the treated children but not the untreated child is unexpected under random conditions. The trends toward beneficial effects of the BBC on speech sound production, expressive language, and communication milestones warrant appropriately powered larger clinical trials with full randomization. Trial registration: ClinicalTrials.gov NCT03838016 (12 th February 2019).",2019,"All four treated children had higher speech sound skills in babble, three had higher speech sound skills in meaningful speech, two had higher expressive vocabularies, and three had higher communication and personal-social skills, compared to the control child with CG. ","['infants with classic galactosemia', 'children with CG', 'Infants with classic galactosemia (CG', 'Method : Five children with CG, otherwise healthy, participated in the BBC from approximately 2 to 24 months of age']","['Babble Boot Camp', 'proactive speech and language treatment', 'control receiving conventional management', 'innovative proactive speech and language intervention program, the Babble Boot Camp (BBC', ': Speech or language therapy']","['speech sound production, expressive language, and communication milestones', 'developmental milestones in communication, motor, and cognition', 'speech sound production complexity in babble and speech and expressive vocabulary size', 'higher communication and personal-social skills', 'higher speech sound skills', 'prespeech, speech, and language stimulation and expansion activities']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0268151', 'cui_str': 'Deficiency of UDPglucose-hexose-1-phosphate uridylyltransferase'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0856983', 'cui_str': 'Babbling'}, {'cui': 'C0331794', 'cui_str': 'Boots'}, {'cui': 'C0001455', 'cui_str': 'Cyclic AMP'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0023017', 'cui_str': 'Language therapy'}]","[{'cui': 'C0037829', 'cui_str': 'Speech Sounds'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0458003', 'cui_str': 'Developmental'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0856983', 'cui_str': 'Babbling'}, {'cui': 'C0037817', 'cui_str': 'Speech'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0679005', 'cui_str': 'Social Abilities'}, {'cui': 'C0589217', 'cui_str': 'Language stimulation'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",5.0,0.032084,"All four treated children had higher speech sound skills in babble, three had higher speech sound skills in meaningful speech, two had higher expressive vocabularies, and three had higher communication and personal-social skills, compared to the control child with CG. ","[{'ForeName': 'Beate', 'Initials': 'B', 'LastName': 'Peter', 'Affiliation': 'Speech and Hearing Science, College of Health Solutions, Arizona State University, Tempe, AZ, USA.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Potter', 'Affiliation': 'Department of Speech and Hearing Sciences, Elson S. Floyd College of Medicine, Washington State University, Spokane, WA, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Davis', 'Affiliation': 'Speech and Hearing Science, College of Health Solutions, Arizona State University, Tempe, AZ, USA.'}, {'ForeName': 'Inbal', 'Initials': 'I', 'LastName': 'Donenfeld-Peled', 'Affiliation': 'Speech and Hearing Science, College of Health Solutions, Arizona State University, Tempe, AZ, USA.'}, {'ForeName': 'Lizbeth', 'Initials': 'L', 'LastName': 'Finestack', 'Affiliation': 'Department of Speech-Language-Hearing Services, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Stoel-Gammon', 'Affiliation': 'Department of Speech and Hearing Sciences, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Kari', 'Initials': 'K', 'LastName': 'Lien', 'Affiliation': 'Speech and Hearing Science, College of Health Solutions, Arizona State University, Tempe, AZ, USA.'}, {'ForeName': 'Laurel', 'Initials': 'L', 'LastName': 'Bruce', 'Affiliation': 'Speech and Hearing Science, College of Health Solutions, Arizona State University, Tempe, AZ, USA.'}, {'ForeName': 'Caitlin', 'Initials': 'C', 'LastName': 'Vose', 'Affiliation': 'Department of Communication Sciences and Disorders, Syracuse University, Syracuse, NY, USA.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Eng', 'Affiliation': 'Speech and Hearing Science, College of Health Solutions, Arizona State University, Tempe, AZ, USA.'}, {'ForeName': 'Hanako', 'Initials': 'H', 'LastName': 'Yokoyama', 'Affiliation': 'Speech and Hearing Science, College of Health Solutions, Arizona State University, Tempe, AZ, USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Olds', 'Affiliation': 'Department of Speech and Hearing Sciences, Elson S. Floyd College of Medicine, Washington State University, Spokane, WA, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'VanDam', 'Affiliation': 'Department of Speech and Hearing Sciences, Elson S. Floyd College of Medicine, Washington State University, Spokane, WA, USA.'}]",F1000Research,['10.12688/f1000research.18062.4'] 1860,32567443,Application of intraoperative electrophysiological monitoring in vertebral canal decompression surgery for acute spinal cord injury.,"OBJECTIVE This study aimed to evaluate the joint monitoring of somatosensory evoked potentials (SEPs) and motor evoked potentials (MEPs) in vertebral canal decompression surgery for acute spinal cord injury. METHODS Twenty-four patients, who were admitted to the hospital for the surgical treatment of spinal cord injury with SEP and MEP monitoring, were assigned to the intraoperative monitoring group (group I). In addition, 24 patients who were admitted to the hospital for the surgical treatment of spinal cord injury without SEP or MEP monitoring were assigned to the control group (group C). RESULTS In group I, there were significant changes before and after decompression surgery in the P40 latency and amplitude, and in the latency of MEP in the abductor hallucis brevis (AHB), in patients with improved spinal nerve function following surgery. In contrast, there were no significant differences in the P40 latency or amplitude, or the latency of MEP in the AHB, in patients who showed no improvement after surgery. CONCLUSION In vertebral canal decompression surgery for acute spinal cord injury, the application of joint MEP and SEP monitoring can timely reflect changes in spinal cord function.",2020,"In group I, there were significant changes before and after decompression surgery in the P40 latency and amplitude, and in the latency of MEP in the abductor hallucis brevis (AHB), in patients with improved spinal nerve function following surgery.","['vertebral canal decompression surgery for acute spinal cord injury', 'Twenty-four patients, who were admitted to the hospital for the surgical treatment of spinal cord injury with SEP and MEP monitoring', '24 patients who were admitted to the hospital for the surgical treatment of spinal cord injury without SEP or MEP monitoring']","['intraoperative monitoring group', 'intraoperative electrophysiological monitoring', 'somatosensory evoked potentials (SEPs) and motor evoked potentials (MEPs', 'vertebral canal decompression surgery']","['latency of MEP in the abductor hallucis brevis (AHB', 'P40 latency or amplitude, or the latency of MEP', 'spinal nerve function']","[{'cui': 'C0037922', 'cui_str': 'Spinal canal structure'}, {'cui': 'C0022983', 'cui_str': 'Laminectomy'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0037929', 'cui_str': 'Spinal cord injury'}, {'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0054871', 'cui_str': 'Cathepsin L'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}]","[{'cui': 'C0079637', 'cui_str': 'Intraoperative Monitoring'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0015216', 'cui_str': 'Somatosensory evoked potential'}, {'cui': 'C0282617', 'cui_str': 'Motor Evoked Potentials'}, {'cui': 'C0037922', 'cui_str': 'Spinal canal structure'}, {'cui': 'C0022983', 'cui_str': 'Laminectomy'}]","[{'cui': 'C0242465', 'cui_str': 'Response Latency'}, {'cui': 'C0054871', 'cui_str': 'Cathepsin L'}, {'cui': 'C0224490', 'cui_str': 'Structure of abductor hallucis muscle'}, {'cui': 'C0079407', 'cui_str': 'Gene Product, tax'}, {'cui': 'C0037941', 'cui_str': 'Spinal nerve structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",24.0,0.0372423,"In group I, there were significant changes before and after decompression surgery in the P40 latency and amplitude, and in the latency of MEP in the abductor hallucis brevis (AHB), in patients with improved spinal nerve function following surgery.","[{'ForeName': 'Qun-Xi', 'Initials': 'QX', 'LastName': 'Li', 'Affiliation': 'Department of Neurosurgery, Affiliated Hospital of North China University of Science and Technology, Tangshan, China.'}, {'ForeName': 'Xiao-Jing', 'Initials': 'XJ', 'LastName': 'Zhao', 'Affiliation': 'Department of Neurology, Affiliated Hospital of North China University of Science and Technology, Tangshan, China.'}, {'ForeName': 'Xiang-Nan', 'Initials': 'XN', 'LastName': 'Li', 'Affiliation': 'Department of Neurosurgery, Affiliated Hospital of North China University of Science and Technology, Tangshan, China.'}, {'ForeName': 'Ai-Jun', 'Initials': 'AJ', 'LastName': 'Fu', 'Affiliation': 'Department of Neurosurgery, Affiliated Hospital of North China University of Science and Technology, Tangshan, China.'}, {'ForeName': 'Yun-He', 'Initials': 'YH', 'LastName': 'Zhang', 'Affiliation': 'Department of Neurosurgery, Affiliated Hospital of North China University of Science and Technology, Tangshan, China.'}, {'ForeName': 'Tong', 'Initials': 'T', 'LastName': 'Chen', 'Affiliation': 'Department of Neurosurgery, Affiliated Hospital of North China University of Science and Technology, Tangshan, China.'}, {'ForeName': 'Tie-Jun', 'Initials': 'TJ', 'LastName': 'Liu', 'Affiliation': 'Department of Anesthesiology, Affiliated Hospital of North China University of Science and Technology, Tangshan, China.'}, {'ForeName': 'Fu-Xia', 'Initials': 'FX', 'LastName': 'Zheng', 'Affiliation': 'Department of Neurology, Affiliated Hospital of North China University of Science and Technology, Tangshan, China.'}, {'ForeName': 'Jian-Min', 'Initials': 'JM', 'LastName': 'Li', 'Affiliation': 'Department of Neurosurgery, Affiliated Hospital of North China University of Science and Technology, Tangshan, China.'}]",The Journal of international medical research,['10.1177/0300060520924205'] 1861,32567996,Analysis of subjective perception and influencing factors of different inclusive education models among prelingually deaf children with a cochlear implant.,"OBJECTIVE We aimed to explore the educational outcome and influencing factors of ongoing verbal rehabilitation training together with inclusive education among prelingually deaf children with a cochlear implant. METHODS Prelingually deaf children who underwent cochlear implantation, rehabilitation, and had inclusive education placement were randomly divided into two groups: one group received continuous verbal rehabilitation training under inclusive education status; the other group did not receive this training. Speech discrimination scores were determined. RESULTS Among 60 included children, subjectively perceived academic adaptability, peer relations, initiative communication, and teacher's involvement under inclusive education, as well as speech discrimination scores, were all significantly different between groups. Continuous verbal rehabilitation training influenced the subjective perception of children and resulted in higher speech discrimination scores and more positive subjective perception. Subjective perception was not significantly correlated with chronological age, sex, age at the time of cochlear implantation, or duration of inclusive education. CONCLUSION Ongoing verbal rehabilitation training within inclusive education can largely improve the education placement outcomes of prelingually deaf children with cochlear implants.",2020,Ongoing verbal rehabilitation training within inclusive education can largely improve the education placement outcomes of prelingually deaf children with cochlear implants.,"['prelingually deaf children with cochlear implants', 'Prelingually deaf children who underwent cochlear implantation, rehabilitation, and had inclusive education placement', 'prelingually deaf children with a cochlear implant']","['continuous verbal rehabilitation training under inclusive education status; the other group did not receive this training', 'verbal rehabilitation training', 'Continuous verbal rehabilitation training']","['Speech discrimination scores', 'positive subjective perception', 'Subjective perception', ""subjectively perceived academic adaptability, peer relations, initiative communication, and teacher's involvement under inclusive education, as well as speech discrimination scores"", 'higher speech discrimination scores']","[{'cui': 'C0525064', 'cui_str': 'Hearing Impaired Persons'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0009199', 'cui_str': 'Cochlear prosthesis'}, {'cui': 'C0302559', 'cui_str': 'Implantation of cochlear prosthetic device'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0557305', 'cui_str': 'Educated at mainstream school'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0557305', 'cui_str': 'Educated at mainstream school'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1299585', 'cui_str': 'Does not'}]","[{'cui': 'C0429202', 'cui_str': 'Speech discrimination score'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0424093', 'cui_str': 'Initiative'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0557305', 'cui_str': 'Educated at mainstream school'}, {'cui': 'C0205250', 'cui_str': 'High'}]",60.0,0.0144398,Ongoing verbal rehabilitation training within inclusive education can largely improve the education placement outcomes of prelingually deaf children with cochlear implants.,"[{'ForeName': 'Xiao-Feng', 'Initials': 'XF', 'LastName': 'Qiao', 'Affiliation': ""Department of Otorhinolaryngology, Shanxi Provincial People's Hospital Affiliated to Shanxi Medical University, Taiyuan, China.""}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Ren', 'Affiliation': 'Shanxi University of Chinese Medicine, Taiyuan, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': ""Department of Otorhinolaryngology, Shanxi Provincial People's Hospital Affiliated to Shanxi Medical University, Taiyuan, China.""}, {'ForeName': 'Tong-Li', 'Initials': 'TL', 'LastName': 'Li', 'Affiliation': ""Department of Otorhinolaryngology, Shanxi Provincial People's Hospital Affiliated to Shanxi Medical University, Taiyuan, China.""}, {'ForeName': 'Redentor S', 'Initials': 'RS', 'LastName': 'Mariano', 'Affiliation': 'Jose Rizal University, Mandaluyong City, Philippines.'}]",The Journal of international medical research,['10.1177/0300060520929855'] 1862,32568470,Coronal Bacterial Penetration after 7 days in class II endodontic access cavities restored with two temporary restorations: A Randomised Clinical Trial.,"The aim of this in vivo randomised clinical trial was to assess coronal bacterial penetration after placement of Cavit G and IRM temporary restorations in class II endodontic access cavities. After completion of endodontic treatment, placement of an orifice seal and disinfection of the operating field, sterile cotton pellets were placed in the pulp chamber and the cavities were restored with Cavit G or IRM. After 7 days, coronal and proximal restoration thickness was measured by digital radiographs. Cotton pellet was evaluated by culture methods and polymerase chain reaction assay and bacterial species identified. Bacterial growth was observed in 5 of the 27 (18%) Cavit G samples and in 11 of the 27 (40%) IRM samples which was not significant. Coronal restoration thickness of 4-5 mm and proximal restoration thickness of more than 2.15 mm for Cavit G and 2.35 mm for IRM are recommended to prevent bacterial penetration over 7 days. Adequate restoration thickness is critical to prevent bacterial penetration.",2020,Bacterial growth was observed in 5 of the 27 (18%) Cavit G samples and in 11 of the 27 (40%),['class II endodontic access cavities'],['Cavit G and IRM temporary restorations'],"['Bacterial growth', 'coronal bacterial penetration', 'coronal and proximal restoration thickness', 'Coronal restoration thickness', 'Coronal Bacterial Penetration']","[{'cui': 'C0441886', 'cui_str': 'Class 2'}, {'cui': 'C0332274', 'cui_str': 'Endodontic'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}]","[{'cui': 'C0054898', 'cui_str': 'Cavit G'}, {'cui': 'C0205374', 'cui_str': 'Transitory'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration'}]","[{'cui': 'C0427944', 'cui_str': 'Determination of bacterial growth'}, {'cui': 'C0205123', 'cui_str': 'Coronal'}, {'cui': 'C0205321', 'cui_str': 'Penetrating'}, {'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration'}, {'cui': 'C1280412', 'cui_str': 'Thick'}]",,0.143247,Bacterial growth was observed in 5 of the 27 (18%) Cavit G samples and in 11 of the 27 (40%),"[{'ForeName': 'Sandhya', 'Initials': 'S', 'LastName': 'Shanmugam', 'Affiliation': 'Department of Conservative Dentistry and Endodontics, Thai Moogambigai Dental College and Hospital, Dr M.G.R. Educational and Research Institute, Chennai, Tamil Nadu, India.'}, {'ForeName': 'Angambakkam Rajasekaran', 'Initials': 'AR', 'LastName': 'PradeepKumar', 'Affiliation': 'Department of Conservative Dentistry and Endodontics, Thai Moogambigai Dental College and Hospital, Dr M.G.R. Educational and Research Institute, Chennai, Tamil Nadu, India.'}, {'ForeName': 'Paul Vincent', 'Initials': 'PV', 'LastName': 'Abbott', 'Affiliation': 'UWA Dental School, The University of Western Australia, Nedlands, WA, Australia.'}, {'ForeName': 'Ravishankar', 'Initials': 'R', 'LastName': 'Periasamy', 'Affiliation': 'Department of Conservative Dentistry and Endodontics, Thai Moogambigai Dental College and Hospital, Dr M.G.R. Educational and Research Institute, Chennai, Tamil Nadu, India.'}, {'ForeName': 'Gopikrishna', 'Initials': 'G', 'LastName': 'Velayutham', 'Affiliation': 'Dept of Conservative Dentistry & Endodontics, Sri Ramachandra Institute of Higher Education & Reasearch, Chennai, Tamil Nadu, India.'}, {'ForeName': 'Sridevi', 'Initials': 'S', 'LastName': 'Krishnamoorthy', 'Affiliation': 'Department of Conservative Dentistry and Endodontics, Thai Moogambigai Dental College and Hospital, Dr M.G.R. Educational and Research Institute, Chennai, Tamil Nadu, India.'}, {'ForeName': 'Krishnan', 'Initials': 'K', 'LastName': 'Mahalakshmi', 'Affiliation': 'Department of Microbiology, Sree Balaji Dental College and Hospital, Pallikaranai, Chennai, Tamil Nadu, India.'}]",Australian endodontic journal : the journal of the Australian Society of Endodontology Inc,['10.1111/aej.12415'] 1863,32563378,"Effects of a high-dose 24-h infusion of tranexamic acid on death and thromboembolic events in patients with acute gastrointestinal bleeding (HALT-IT): an international randomised, double-blind, placebo-controlled trial.","BACKGROUND Tranexamic acid reduces surgical bleeding and reduces death due to bleeding in patients with trauma. Meta-analyses of small trials show that tranexamic acid might decrease deaths from gastrointestinal bleeding. We aimed to assess the effects of tranexamic acid in patients with gastrointestinal bleeding. METHODS We did an international, multicentre, randomised, placebo-controlled trial in 164 hospitals in 15 countries. Patients were enrolled if the responsible clinician was uncertain whether to use tranexamic acid, were aged above the minimum age considered an adult in their country (either aged 16 years and older or aged 18 years and older), and had significant (defined as at risk of bleeding to death) upper or lower gastrointestinal bleeding. Patients were randomly assigned by selection of a numbered treatment pack from a box containing eight packs that were identical apart from the pack number. Patients received either a loading dose of 1 g tranexamic acid, which was added to 100 mL infusion bag of 0·9% sodium chloride and infused by slow intravenous injection over 10 min, followed by a maintenance dose of 3 g tranexamic acid added to 1 L of any isotonic intravenous solution and infused at 125 mg/h for 24 h, or placebo (sodium chloride 0·9%). Patients, caregivers, and those assessing outcomes were masked to allocation. The primary outcome was death due to bleeding within 5 days of randomisation; analysis excluded patients who received neither dose of the allocated treatment and those for whom outcome data on death were unavailable. This trial was registered with Current Controlled Trials, ISRCTN11225767, and ClinicalTrials.gov, NCT01658124. FINDINGS Between July 4, 2013, and June 21, 2019, we randomly allocated 12 009 patients to receive tranexamic acid (5994, 49·9%) or matching placebo (6015, 50·1%), of whom 11 952 (99·5%) received the first dose of the allocated treatment. Death due to bleeding within 5 days of randomisation occurred in 222 (4%) of 5956 patients in the tranexamic acid group and in 226 (4%) of 5981 patients in the placebo group (risk ratio [RR] 0·99, 95% CI 0·82-1·18). Arterial thromboembolic events (myocardial infarction or stroke) were similar in the tranexamic acid group and placebo group (42 [0·7%] of 5952 vs 46 [0·8%] of 5977; 0·92; 0·60 to 1·39). Venous thromboembolic events (deep vein thrombosis or pulmonary embolism) were higher in tranexamic acid group than in the placebo group (48 [0·8%] of 5952 vs 26 [0·4%] of 5977; RR 1·85; 95% CI 1·15 to 2·98). INTERPRETATION We found that tranexamic acid did not reduce death from gastrointestinal bleeding. On the basis of our results, tranexamic acid should not be used for the treatment of gastrointestinal bleeding outside the context of a randomised trial. FUNDING UK National Institute for Health Research Health Technology Assessment Programme.",2020,Venous thromboembolic events (deep vein thrombosis or pulmonary embolism) were higher in tranexamic acid group than in the placebo group (48 [0·8%] of 5952 vs 26 [0·4%] of 5977;,"['patients with gastrointestinal bleeding', 'Patients were enrolled if the responsible clinician was uncertain whether to use tranexamic acid, were aged above the minimum age considered an adult in their country (either aged 16 years and older or aged 18 years and older), and had significant (defined as at risk of bleeding to death) upper or lower gastrointestinal bleeding', 'patients with trauma', '164 hospitals in 15 countries', 'patients with acute gastrointestinal bleeding (HALT-IT', 'Between July 4, 2013, and June 21, 2019, we randomly allocated 12\u2008009 patients to receive']","['Tranexamic acid', 'placebo', 'matching placebo', 'tranexamic acid added to 1 L of any isotonic intravenous solution and infused at 125 mg/h for 24 h, or placebo (sodium chloride 0·9', 'tranexamic acid', '0·9% sodium chloride']","['death due to bleeding', 'death and thromboembolic events', 'Venous thromboembolic events (deep vein thrombosis or pulmonary embolism', 'Arterial thromboembolic events (myocardial infarction or stroke', 'Death due to bleeding', 'death from gastrointestinal bleeding']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0017181', 'cui_str': 'Gastrointestinal hemorrhage'}, {'cui': 'C1273518', 'cui_str': 'Responsible to'}, {'cui': 'C0087130', 'cui_str': 'Uncertain'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0024050', 'cui_str': 'Lower gastrointestinal hemorrhage'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0266807', 'cui_str': 'Acute gastrointestinal hemorrhage'}]","[{'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0454287', 'cui_str': 'Isotonic exercise'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C4707055', 'cui_str': 'Infuse'}, {'cui': 'C0104485', 'cui_str': 'AT 125'}, {'cui': 'C0439421', 'cui_str': 'mg/h'}, {'cui': 'C0037494', 'cui_str': 'Sodium Chloride'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0040038', 'cui_str': 'Thromboembolus'}, {'cui': 'C0042449', 'cui_str': 'Venous structure'}, {'cui': 'C0149871', 'cui_str': 'Deep venous thrombosis'}, {'cui': 'C0034065', 'cui_str': 'Pulmonary embolism'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0017181', 'cui_str': 'Gastrointestinal hemorrhage'}]",12009.0,0.734066,Venous thromboembolic events (deep vein thrombosis or pulmonary embolism) were higher in tranexamic acid group than in the placebo group (48 [0·8%] of 5952 vs 26 [0·4%] of 5977;,"[{'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Lancet (London, England)",['10.1016/S0140-6736(20)30848-5'] 1864,31219175,Adult Day Service Use Decreases Likelihood of a Missed Physician's Appointment Among Dementia Caregivers.,"BACKGROUND/OBJECTIVE Adult day services (ADSs) that provide community-based supervised support for persons with dementia (PWD) may also function as a respite for familial caregivers to attend to self-care needs. Guided by a revised version of the Andersen Healthcare Utilization Model, the objective of this study was to identify the association between use of ADSs and a missed physician's appointment among family caregivers for community-dwelling familial PWD. A secondary objective was to identify other predisposing, enabling, and need factors associated with a missed physician's appointment. DESIGN Secondary analysis of baseline, cross-sectional data from two randomized controlled trials (Advancing Caregiver Training, n = 272; and Care of Persons With Dementia in Their Environments, n = 237). SETTING Community. PARTICIPANTS Community-dwelling caregivers for PWD (n = 509). MEASUREMENTS Missed physician's appointment was measured using the caregivers' self-report of one or more missed physician's appointments (yes/no) in the past 6 months. ADS use was measured using the caregivers' self-report of ADS use (yes/no). RESULTS Over a third of the caregivers utilized ADSs for their PWD. Caregivers who utilized ADSs for their familial PWD were 49% less likely (95% confidence interval = 0.32-0.81) to miss a physician's appointment in the past 6 months. More black compared to white caregivers missed appointments regardless of ADS use. Caregivers with increased chronic health conditions were more likely to miss a physician's appointment compared to those with fewer conditions. CONCLUSION ADSs' provision of respite enables caregivers the time to address self-care needs by decreasing the likelihood that caregivers miss a physician's appointment. Findings suggest that ADSs may promote positive health behaviors for caregivers and should be expanded as part of comprehensive dementia care for families. Factors associated with missed physician appointments need further examination and intervention to support black caregivers.",2019,Caregivers who utilized ADSs for their familial PWD were 49% less likely (95% confidence interval = 0.32-0.81) to miss a physician's appointment in the past 6 months.,"['Dementia Caregivers', 'persons with dementia (PWD', 'Community', 'Community-dwelling caregivers for PWD (n = 509', 'Persons With Dementia in Their Environments, n = 237', 'family caregivers for community-dwelling familial PWD']",[],"['chronic health conditions', 'positive health behaviors']","[{'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0086279', 'cui_str': 'Family Caregivers'}, {'cui': 'C0015576', 'cui_str': 'Family'}]",[],"[{'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",509.0,0.0348899,Caregivers who utilized ADSs for their familial PWD were 49% less likely (95% confidence interval = 0.32-0.81) to miss a physician's appointment in the past 6 months.,"[{'ForeName': 'Lauren J', 'Initials': 'LJ', 'LastName': 'Parker', 'Affiliation': 'Department of Health, Behavior, and Society, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.'}, {'ForeName': 'Joseph E', 'Initials': 'JE', 'LastName': 'Gaugler', 'Affiliation': 'Long-Term Care and Aging, School of Public Health, University of Minnesota, Minneapolis, Minnesota.'}, {'ForeName': 'Quincy', 'Initials': 'Q', 'LastName': 'Samus', 'Affiliation': 'Psychiatry and Behavioral Sciences, Johns Hopkins School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Laura N', 'Initials': 'LN', 'LastName': 'Gitlin', 'Affiliation': 'College of Nursing and Health Professions, Drexel University, Philadelphia, Pennsylvania.'}]",Journal of the American Geriatrics Society,['10.1111/jgs.15995'] 1865,32449228,"Internet-based intervention for postpartum depression in China (""Mommy go""): Protocol for a randomized controlled trial.","AIM The purpose of this study is to design a research protocol for the clinical testing of the ""Mommy go"" for pregnant women with a risk of postpartum depression. DESIGN A non-blinded randomized controlled trial. METHODS A randomized controlled study will be performed from January 2018 to the completion of the study. The intervention group will follow the ""Mommy go"" protocol and the control group will receive traditional support. We will use the Edinburgh Postpartum Depression Scale and the Chinese version of the Postpartum Depression Predictors Inventory-Revised to measure the risk of postpartum depression in pregnant women. The outcomes are clinical data, postpartum depressive mood, self-efficacy, and infant temperament. Outcomes will be assessed using questionnaires and through data generated by digital technologies. DISCUSSION The expected outcomes are increased self-efficacy and infant temperament, reduced postpartum depressive mood, and improvements to postpartum depression. We expect the study to have a clinical impact on future online interventions for postpartum depression in China. IMPACT This study will provide an internet-based intervention for postpartum depression in China. It will be implemented in clinical practice if it can effectively improve postpartum depression. TRIAL REGISTRATION Registered at the Chinese Clinical Trials.gov (ChiCTR1800018804).",2020,"The expected outcomes are increased self-efficacy and infant temperament, reduced postpartum depressive mood and improvements to postpartum depression.","['postpartum depression in China', 'pregnant women with a risk of postpartum depression', 'pregnant women']","['Mommy go"" protocol and the control group will receive traditional support', 'Internet-Based Intervention']","['clinical data, postpartum depressive mood, self-efficacy and infant temperament', 'self-efficacy and infant temperament, reduced postpartum depressive mood and improvements to postpartum depression']","[{'cui': 'C0221074', 'cui_str': 'Postpartum depression'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]","[{'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C3898714', 'cui_str': 'Internet Intervention'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0039474', 'cui_str': 'Temperament'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0221074', 'cui_str': 'Postpartum depression'}]",,0.155209,"The expected outcomes are increased self-efficacy and infant temperament, reduced postpartum depressive mood and improvements to postpartum depression.","[{'ForeName': 'Yu-Hong', 'Initials': 'YH', 'LastName': 'Li', 'Affiliation': 'Nursing College, Anhui Medical University, Hefei, Anhui, P.R. China.'}, {'ForeName': 'Ting-Yu', 'Initials': 'TY', 'LastName': 'Mu', 'Affiliation': 'Nursing College, Anhui Medical University, Hefei, Anhui, P.R. China.'}, {'ForeName': 'Liu', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Nursing College, Anhui Medical University, Hefei, Anhui, P.R. China.'}, {'ForeName': 'Cheng-Lu', 'Initials': 'CL', 'LastName': 'Zhang', 'Affiliation': 'Nursing College, Anhui Medical University, Hefei, Anhui, P.R. China.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Wu', 'Affiliation': 'The Second Affiliated Hospital of Anhui Medical University, Hefei, Anhui, P.R., China.'}, {'ForeName': 'Jin-Ju', 'Initials': 'JJ', 'LastName': 'Chen', 'Affiliation': 'The Second Affiliated Hospital of Anhui Medical University, Hefei, Anhui, P.R., China.'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Wang', 'Affiliation': 'The Second Affiliated Hospital of Anhui Medical University, Hefei, Anhui, P.R., China.'}]",Journal of advanced nursing,['10.1111/jan.14436'] 1866,32551853,S-1 Maintenance Therapy in Extensive Stage Small-Cell Lung Cancer-A Randomized Clinical Study.,"Small-cell lung cancer (SCLC) is a recalcitrant cancer for its dismal prognosis although extensive research had been done. Four to 6 cycles platinum-based chemotherapy is the mainstay treatment for the extensive-stage disease; but the role of maintenance treatment is not fully understood. This is a phase 2, open-label study. Patients with extensive-stage SCLC reaching an objective response or stable disease (SD) after induction chemotherapy were randomly assigned (1:1) with a minimization procedure. One group received oral S-1 and the other group received placebo as maintenance treatment until disease progression or unacceptable toxicities. The primary end point of this study was progression-free survival (PFS), and the secondary end points were overall survival (OS), response rates, and toxicities. This study was based on earlier work, the preliminary results was reported on 2019 ASCO annual meeting. A total of 89 patients were enrolled, of whom 45 received S-1 maintenance therapy and 44 received placebo. The median PFS and OS were 6.35 months and 10.82 months in the S-1 group, as compared to 5.98 months and 10.09 months in the placebo group. The PFS was 7.2 months and 5.3 months, and OS was 12.9 months and 10.9 months in patients with an objective response compared to in patients with SD after induction chemotherapy, respectively. S-1 maintenance therapy did not prolong PFS or OS in patients with extensive-stage SCLC; tumor regression rate was the prognostic factor of PFS or OS. Further research with novel agents in the maintenance setting is warranted.",2020,maintenance therapy did not prolong PFS or OS in patients with extensive-stage SCLC; tumor regression rate was the prognostic factor of PFS or OS.,"['Patients with extensive-stage SCLC reaching an objective response or stable disease (SD) after induction chemotherapy', '89 patients were enrolled, of whom 45 received', 'patients with extensive-stage SCLC', 'Extensive Stage Small-Cell Lung Cancer']","['S-1 maintenance therapy', 'S-1 Maintenance Therapy', 'S-1', 'oral S-1', 'platinum-based chemotherapy', 'placebo']","['progression-free survival (PFS', 'PFS or OS', 'overall survival (OS), response rates, and toxicities', 'median PFS and OS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0278726', 'cui_str': 'Small cell lung cancer extensive stage'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C3179010', 'cui_str': 'Induction chemotherapy'}]","[{'cui': 'C0879262', 'cui_str': 'S 1 (combination)'}, {'cui': 'C0677908', 'cui_str': 'Maintenance therapy'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C3536920', 'cui_str': 'Platinum compounds'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",89.0,0.074097,maintenance therapy did not prolong PFS or OS in patients with extensive-stage SCLC; tumor regression rate was the prognostic factor of PFS or OS.,"[{'ForeName': 'Keke', 'Initials': 'K', 'LastName': 'Nie', 'Affiliation': 'Department of Oncology, Qingdao Central Hospital, Qingdao University, China.'}, {'ForeName': 'Xiuhui', 'Initials': 'X', 'LastName': 'Guo', 'Affiliation': ""Pingdu People's Hospital, Qingdao, China.""}, {'ForeName': 'Yunhong', 'Initials': 'Y', 'LastName': 'You', 'Affiliation': 'Department of Oncology, Qingdao Central Hospital, Qingdao University, China.'}, {'ForeName': 'Xingjun', 'Initials': 'X', 'LastName': 'Zhuang', 'Affiliation': 'Department of Oncology, PLA 971 Hospital, Qingdao City, China.'}, {'ForeName': 'Chunling', 'Initials': 'C', 'LastName': 'Zhang', 'Affiliation': 'Department of Oncology, Qingdao Central Hospital, Qingdao University, China.'}, {'ForeName': 'Youxin', 'Initials': 'Y', 'LastName': 'Ji', 'Affiliation': 'Department of Oncology, Qingdao Central Hospital, Qingdao University, China.'}]",Cancer control : journal of the Moffitt Cancer Center,['10.1177/1073274820932004'] 1867,32554072,Downregulating the P2X3 receptor in the carotid body to reduce blood pressure via acoustic gene delivery in canines.,"The purinergic P2X3 receptor in the carotid body (CB) is considered a new target for treating hypertension, although approaches for targeted regulating P2X3 receptor expression are lacking. Here, we explored the feasibility of targeted P2X3 receptor down-regulation in CBs by localized low-intensity focused ultrasound (LIFU)-mediated gene delivery to reduce the blood pressure. Thirty-two Kunming canines were randomly assigned to the treatment group (n = 14), negative control group (n = 10), LIFU + cationic microbubbles group (n = 4), and LIFU-only group (n = 4). Plasmid-loaded cationic microbubbles were injected and bilateral CBs were irradiated with a LIFU-based transducer. Flow cytometry showed that 33.15% of transfected cells expressed the green fluorescent protein reporter gene. T7 endonuclease I assays showed an insertion-deletion rate of 8.30%. The P2X3 receptor mRNA- and protein-expression levels in CBs decreased by 56.31% and 45.10%, respectively, in the treatment group. Mean systolic (152.5 ± 3.0 vs 138.0 ± 2.9 mm Hg, P = 0.003) and diastolic (97.8 ± 1.5 vs 87.2 ± 2.3 mm Hg, P= 0.002) blood pressures reduced on day 14 in the treatment group, compared with the baseline values, whereas no effects were observed with LIFU treatment or cationic microbubbles injection alone. Canines treated with this strategy exhibited no local or systemic adverse events. Thus, LIFU-mediated gene delivery to CBs successfully modulated CB function and reduced blood pressure in a canine model, suggesting a new possibility for treating hypertension and further clinical translation.",2020,"The P2 × 3 receptor mRNA- and protein-expression levels in CBs decreased by 56.31% and 45.10%, respectively, in the treatment group.",['Thirty-two Kunming canines'],"['negative control group (n\u202f=\u202f10), LIFU\u202f+\u202fcationic microbubbles group (n\u202f=\u202f4), and LIFU-only group']","['insertion-deletion rate', 'blood pressure', 'Mean systolic', 'local or systemic adverse events', 'blood pressures', 'protein-expression levels in CBs']","[{'cui': 'C0450357', 'cui_str': '32'}, {'cui': 'C0010482', 'cui_str': 'Structure of canine tooth'}]","[{'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0596836', 'cui_str': 'Light intensity'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C1258018', 'cui_str': 'Microbubbles'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C1956002', 'cui_str': 'Insertion-Deletion Mutation'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.0504845,"The P2 × 3 receptor mRNA- and protein-expression levels in CBs decreased by 56.31% and 45.10%, respectively, in the treatment group.","[{'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Xue', 'Affiliation': 'Department of Cardiology, The Second Affiliated Hospital of Chongqing Medical University, Chongqing, China.'}, {'ForeName': 'Ruiyu', 'Initials': 'R', 'LastName': 'Wang', 'Affiliation': 'Department of Cardiology, The Second Affiliated Hospital of Chongqing Medical University, Chongqing, China.'}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Department of Cardiology, The Second Affiliated Hospital of Chongqing Medical University, Chongqing, China.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Xiong', 'Affiliation': 'Department of Cardiology, The Second Affiliated Hospital of Chongqing Medical University, Chongqing, China.'}, {'ForeName': 'Lingjiao', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Department of Cardiology, The Second Affiliated Hospital of Chongqing Medical University, Chongqing, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Qian', 'Affiliation': 'Department of Cardiology, The Second Affiliated Hospital of Chongqing Medical University, Chongqing, China.'}, {'ForeName': 'Lan', 'Initials': 'L', 'LastName': 'Hao', 'Affiliation': 'Chongqing Key Laboratory of Ultrasound Molecular Imaging, Chongqing Medical University, Chongqing, China.'}, {'ForeName': 'Zhigang', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Chongqing Key Laboratory of Ultrasound Molecular Imaging, Chongqing Medical University, Chongqing, China.'}, {'ForeName': 'Dichuan', 'Initials': 'D', 'LastName': 'Liu', 'Affiliation': 'Department of Cardiology, The Second Affiliated Hospital of Chongqing Medical University, Chongqing, China.'}, {'ForeName': 'Changming', 'Initials': 'C', 'LastName': 'Deng', 'Affiliation': 'Department of Cardiology, The Second Affiliated Hospital of Chongqing Medical University, Chongqing, China.'}, {'ForeName': 'Shunkang', 'Initials': 'S', 'LastName': 'Rong', 'Affiliation': 'Department of Cardiology, The Second Affiliated Hospital of Chongqing Medical University, Chongqing, China.'}, {'ForeName': 'Yuanqing', 'Initials': 'Y', 'LastName': 'Yao', 'Affiliation': 'Department of Cardiology, The Second Affiliated Hospital of Chongqing Medical University, Chongqing, China.'}, {'ForeName': 'Yonghong', 'Initials': 'Y', 'LastName': 'Jiang', 'Affiliation': 'Department of Cardiology, The Second Affiliated Hospital of Chongqing Medical University, Chongqing, China.'}, {'ForeName': 'Que', 'Initials': 'Q', 'LastName': 'Zhu', 'Affiliation': 'Department of Cardiology, The Second Affiliated Hospital of Chongqing Medical University, Chongqing, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Huang', 'Affiliation': 'Department of Cardiology, The Second Affiliated Hospital of Chongqing Medical University, Chongqing, China; Institute of Ultrasound Imaging, Department of Ultrasound, The Second Affiliated Hospital of Chongqing Medical University, Chongqing, China. Electronic address: huangjing@cqmu.edu.cn.'}]",Translational research : the journal of laboratory and clinical medicine,['10.1016/j.trsl.2020.06.005'] 1868,32554105,Cost-effectiveness of a collaborative care program for managing major depression and chronic musculoskeletal pain in primary care: Economic evaluation alongside a randomized controlled trial.,"BACKGROUND We designed a collaborative care program for the integrated management of chronic musculoskeletal pain and depression, which frequently coexist in primary care patients. The aim of this study was to evaluate the cost-effectiveness of this program compared with care as usual. METHODS We performed a cost-effectiveness analysis alongside a randomized clinical trial. Results were monitored over a 12-month period. The primary outcome was the incremental cost-effectiveness ratio (ICER). We performed cost-effectiveness analyses from the perspectives of the healthcare system and society using an intention-to-treat approach with imputation of missing values. RESULTS We evaluated 328 patients (167 in the intervention group and 161 in the control group) with chronic musculoskeletal pain and major depression at baseline. From the healthcare system perspective, the mean incremental cost was €234 (p = .17) and the mean incremental effectiveness was 0.009 QALYs (p = .66), resulting in an ICER of €23,989/QALY. Costs from the societal perspective were €235 (p = .16), yielding an ICER of €24,102/QALY. These estimates were associated with a high degree of uncertainty illustrated on the cost-effectiveness plane. CONCLUSIONS Contrary to our expectations, the collaborative care program had no significant effects on health status, and although the additional costs of implementing the program compared with care as usual were not high, we were unable to demonstrate a favorable cost-effectiveness ratio, largely due to the high degree of uncertainty surrounding the estimates.",2020,"Costs from the societal perspective were €235 (p = .16), yielding an ICER of €24,102/QALY.","['328 patients (167 in the intervention group and 161 in the control group) with chronic musculoskeletal pain and major depression at baseline', 'primary care patients', 'managing major depression and chronic musculoskeletal pain in primary care']",['collaborative care program'],"['Cost-effectiveness', 'mean incremental effectiveness', 'mean incremental cost', 'health status', 'cost-effectiveness', 'incremental cost-effectiveness ratio (ICER']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517595', 'cui_str': '167'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0746683', 'cui_str': 'Chronic musculoskeletal pain'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}]","[{'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",328.0,0.0923458,"Costs from the societal perspective were €235 (p = .16), yielding an ICER of €24,102/QALY.","[{'ForeName': 'Enric', 'Initials': 'E', 'LastName': 'Aragonès', 'Affiliation': ""Institut Universitari d'Investigació en Atenció Primària Jordi Gol (IDIAP Jordi Gol), Barcelona, Spain; Atenció Primària Camp de Tarragona, Institut Català de la Salut, Tarragona, Spain. Electronic address: earagones.tgn.ics@gencat.cat.""}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Sánchez-Iriso', 'Affiliation': 'Department of Economics, Public University of Navarra, Pamplona, Spain; Instituto de Investigación Sanitaria de Navarra (IdiSNA), Pamplona, Spain.'}, {'ForeName': 'Germán', 'Initials': 'G', 'LastName': 'López-Cortacans', 'Affiliation': ""Institut Universitari d'Investigació en Atenció Primària Jordi Gol (IDIAP Jordi Gol), Barcelona, Spain; Atenció Primària Camp de Tarragona, Institut Català de la Salut, Tarragona, Spain.""}, {'ForeName': 'Catarina', 'Initials': 'C', 'LastName': 'Tomé-Pires', 'Affiliation': ""Institut Universitari d'Investigació en Atenció Primària Jordi Gol (IDIAP Jordi Gol), Barcelona, Spain; ISCTE-Lisbon University Institute (ISCTE-IUL), Center for Social Research and Intervention (CIS-IUL), Lisbon, Portugal.""}, {'ForeName': 'Concepción', 'Initials': 'C', 'LastName': 'Rambla', 'Affiliation': ""Institut Universitari d'Investigació en Atenció Primària Jordi Gol (IDIAP Jordi Gol), Barcelona, Spain; Atenció Primària Camp de Tarragona, Institut Català de la Salut, Tarragona, Spain.""}, {'ForeName': 'Elisabet', 'Initials': 'E', 'LastName': 'Sánchez-Rodríguez', 'Affiliation': ""Unit for the Study and Treatment of Pain - ALGOS, Research Center for Behavior Assessment (CRAMC), Department of Psychology, Universitat Rovira i Virgili, Tarragona, Spain; Institut d'Investigació Sanitària Pere Virgili, Universitat Rovira i Virgili, Tarragona, Spain.""}]",Journal of psychosomatic research,['10.1016/j.jpsychores.2020.110167'] 1869,32554135,The relationship between the tympanostomy tube extrusion time and viscosity.,"OBJECTIVE The purpose of the study was to assess the correlation between the tympanostomy tube extrusion time and the viscosity of the middle ear fluid. METHODS Thirty-three patients who were scheduled for a tympanostomy tube (TT) insertion were included in the study. During the paracentesis procedure, fluid from the middle ear was obtained, and the viscosity was measured with a viscometer. Patients with effusion values below and above the median viscosity value of 439 cP (cP) were assigned to Group 1 and Group 2, respectively. After the surgery, the patients were followed up monthly until the tubes were observed to be extruded. RESULTS The analysis of the correlation between the tube extrusion time and the viscosity was statistically insignificant (p > 0.05). The mean tube extrusion time of Group 1 (12.65 ± 4.152 months) was slightly lower than that of Group 2 (13.81 ± 4.43 months); however, the difference was not statistically significant. CONCLUSION The tube extrusion time can be longer or shorter and is independent of the effusion viscosity. Further studies are needed to clarify the factors that affect the TT extrusion time. TRIAL REGISTRATION NUMBER NCT03848026.",2020,The analysis of the correlation between the tube extrusion time and the viscosity was statistically insignificant (p > 0.05).,"['Patients with effusion values below and above the median viscosity value of 439\xa0cP (cP', 'Thirty-three patients who were scheduled for a tympanostomy tube (TT) insertion were included in the study']",[],"['mean tube extrusion time', 'tube extrusion time and the viscosity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013687', 'cui_str': 'Effusion'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0042784', 'cui_str': 'Viscosity'}, {'cui': 'C0450358', 'cui_str': '33'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0850121', 'cui_str': 'Tympanic ventilation tube'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]",[],"[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0175730', 'cui_str': 'Tube'}, {'cui': 'C0443213', 'cui_str': 'Extrusion'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0042784', 'cui_str': 'Viscosity'}]",33.0,0.0301946,The analysis of the correlation between the tube extrusion time and the viscosity was statistically insignificant (p > 0.05).,"[{'ForeName': 'Nazan', 'Initials': 'N', 'LastName': 'Degirmenci', 'Affiliation': 'Bezmialem Vakif University, Department of Otorhinolaryngology and Head and Neck Surgery, Istanbul, Turkey. Electronic address: ndegirmenci@bezmialem.edu.tr.'}, {'ForeName': 'Selahattin', 'Initials': 'S', 'LastName': 'Tugrul', 'Affiliation': 'Bezmialem Vakif University, Department of Otorhinolaryngology and Head and Neck Surgery, Istanbul, Turkey. Electronic address: selahattintugrul@yahoo.com.'}, {'ForeName': 'Seda Sezen', 'Initials': 'SS', 'LastName': 'Goktas', 'Affiliation': '75. Yil Boyabat State Hospital, Department of Otorhinolaryngology and Head and Neck Surgery, Sinop, Turkey. Electronic address: sedasezengoktas@gmail.com.'}, {'ForeName': 'Erol', 'Initials': 'E', 'LastName': 'Senturk', 'Affiliation': 'Bezmialem Vakif University, Department of Otorhinolaryngology and Head and Neck Surgery, Istanbul, Turkey. Electronic address: erolsent@gmail.com.'}, {'ForeName': 'Omer Faruk', 'Initials': 'OF', 'LastName': 'Calim', 'Affiliation': 'Bezmialem Vakif University, Department of Otorhinolaryngology and Head and Neck Surgery, Istanbul, Turkey. Electronic address: omercalim@yahoo.com.'}, {'ForeName': 'Remzi', 'Initials': 'R', 'LastName': 'Dogan', 'Affiliation': 'Bezmialem Vakif University, Department of Otorhinolaryngology and Head and Neck Surgery, Istanbul, Turkey. Electronic address: dr.remzidogan@hotmail.com.'}, {'ForeName': 'Alper', 'Initials': 'A', 'LastName': 'Yenigun', 'Affiliation': 'Bezmialem Vakif University, Department of Otorhinolaryngology and Head and Neck Surgery, Istanbul, Turkey. Electronic address: alperyenigun@gmail.com.'}, {'ForeName': 'Orhan', 'Initials': 'O', 'LastName': 'Ozturan', 'Affiliation': 'Bezmialem Vakif University, Department of Otorhinolaryngology and Head and Neck Surgery, Istanbul, Turkey. Electronic address: orhanent@yahoo.com.'}]",International journal of pediatric otorhinolaryngology,['10.1016/j.ijporl.2020.110140'] 1870,32554173,Neuroendocrine biomarkers of prolonged exposure treatment response in military-related PTSD.,"Posttraumatic stress disorder (PTSD) is associated with dysregulation of the neuroendocrine system, including cortisol, allopregnanolone, and pregnanolone. Preliminary evidence from animal models suggests that baseline levels of these biomarkers may predict response to PTSD treatment. We report the change in biomarkers over the course of PTSD treatment. Biomarkers were sampled from individuals participating in (1) a randomized controlled trial comparing a web-version of Prolonged Exposure (Web-PE) therapy to in-person Present-Centered Therapy (PCT) and (2) from individuals participating in a nonrandomized effectiveness study testing PE delivered in-person as part of an intensive outpatient PTSD program. We found that higher cortisol reactivity during script-driven imagery was associated with higher baseline PTSD severity and that baseline allopregnanolone, pregnanolone, and cortisol reactivity were associated with degree of symptom change over the course of intensive outpatient treatment. These findings demonstrate that peripherally assessed biomarkers are associated with PTSD severity and likelihood of successful treatment outcome of PE delivered daily over two weeks. These assessments could be used to determine which patients are likely to respond to treatment and which patients require augmentation to increase the likelihood of optimal response to PTSD treatment.",2020,"Posttraumatic stress disorder (PTSD) is associated with dysregulation of the neuroendocrine system, including cortisol, allopregnanolone, and pregnanolone.","['military-related PTSD', 'Posttraumatic stress disorder (PTSD']","['web-version of Prolonged Exposure (Web-PE) therapy to in-person Present-Centered Therapy (PCT', 'pregnanolone']",['higher cortisol reactivity'],"[{'cui': 'C0026126', 'cui_str': 'Military personnel'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0033008', 'cui_str': '3 alpha, 5 beta-Tetrahydroprogesterone'}]","[{'cui': 'C0541847', 'cui_str': 'Cortisol increased'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}]",,0.0279829,"Posttraumatic stress disorder (PTSD) is associated with dysregulation of the neuroendocrine system, including cortisol, allopregnanolone, and pregnanolone.","[{'ForeName': 'Sheila A M', 'Initials': 'SAM', 'LastName': 'Rauch', 'Affiliation': 'Atlanta VA Medical Center, 1670 Clairmont Road, Decatur, GA, 30033, USA; Emory University School of Medicine, Department of Psychiatry and Behavioral Sciences, 12 Executive Park, 3rd Floor, Atlanta, GA, 30029, USA. Electronic address: sheila.a.m.rauch@emory.edu.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Sripada', 'Affiliation': 'VA Ann Arbor Healthcare System, 2215 Fuller Road, Ann Arbor, MI, 48105, USA; University of Michigan, Department of Psychiatry, 4250 Plymouth Road, Ann Arbor, MI, 48109, USA. Electronic address: rekaufma@med.umich.edu.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Burton', 'Affiliation': 'Emory University School of Medicine, Department of Psychiatry and Behavioral Sciences, 12 Executive Park, 3rd Floor, Atlanta, GA, 30029, USA. Electronic address: mark.steven.burton@emory.edu.'}, {'ForeName': 'Vasiliki', 'Initials': 'V', 'LastName': 'Michopoulos', 'Affiliation': 'Emory University School of Medicine, Department of Psychiatry and Behavioral Sciences, 12 Executive Park, 3rd Floor, Atlanta, GA, 30029, USA. Electronic address: vmichop@emory.edu.'}, {'ForeName': 'Kimberly', 'Initials': 'K', 'LastName': 'Kerley', 'Affiliation': 'Emory University School of Medicine, Department of Psychiatry and Behavioral Sciences, 12 Executive Park, 3rd Floor, Atlanta, GA, 30029, USA. Electronic address: kimberly.kerley@emory.edu.'}, {'ForeName': 'Christine E', 'Initials': 'CE', 'LastName': 'Marx', 'Affiliation': 'Duke University School of Medicine, Department of Psychiatry and Behavioral Sciences, 40 Duke Medicine Circle, Durham, NC, 27710, USA; Durham Veterans Administration Medical Center and VA Mid-Atlantic MIRECC, 508 Fulton Street, Durham, NC, 27705, USA. Electronic address: christine.marx@duke.edu.'}, {'ForeName': 'Jason D', 'Initials': 'JD', 'LastName': 'Kilts', 'Affiliation': 'Duke University School of Medicine, Department of Psychiatry and Behavioral Sciences, 40 Duke Medicine Circle, Durham, NC, 27710, USA; Durham Veterans Administration Medical Center and VA Mid-Atlantic MIRECC, 508 Fulton Street, Durham, NC, 27705, USA. Electronic address: jason.kilts@duke.edu.'}, {'ForeName': 'Jennifer C', 'Initials': 'JC', 'LastName': 'Naylor', 'Affiliation': 'Duke University School of Medicine, Department of Psychiatry and Behavioral Sciences, 40 Duke Medicine Circle, Durham, NC, 27710, USA; Durham Veterans Administration Medical Center and VA Mid-Atlantic MIRECC, 508 Fulton Street, Durham, NC, 27705, USA. Electronic address: jennifer.naylor@duke.edu.'}, {'ForeName': 'Barbara O', 'Initials': 'BO', 'LastName': 'Rothbaum', 'Affiliation': 'Emory University School of Medicine, Department of Psychiatry and Behavioral Sciences, 12 Executive Park, 3rd Floor, Atlanta, GA, 30029, USA. Electronic address: brothba@emory.edu.'}, {'ForeName': 'Carmen P', 'Initials': 'CP', 'LastName': 'McLean', 'Affiliation': 'National Center for PTSD, Dissemination and Training Division, VA Palo Alto Health Care System, 795 Willow Rd, Menlo Park, CA, 94025, USA; Stanford University School of Medicine, Department of Psychiatry and Behavioral Sciences, 291 Campus Dr., Stanford, CA, 94305, USA. Electronic address: Carmen.McLean4@va.gov.'}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Smith', 'Affiliation': 'Emory University School of Medicine, Department of Obstetrics and Gynecology, 101 Woodruff Circle NE, Ste 4217, Atlanta, 30322, USA. Electronic address: alicia.smith@emory.edu.'}, {'ForeName': 'Seth D', 'Initials': 'SD', 'LastName': 'Norrholm', 'Affiliation': 'Atlanta VA Medical Center, 1670 Clairmont Road, Decatur, GA, 30033, USA; Wayne State University, 3901 Chrysler Dr, Detroit, MI, 48201, USA. Electronic address: SNorrholm@wayne.edu.'}, {'ForeName': 'Tanja', 'Initials': 'T', 'LastName': 'Jovanovic', 'Affiliation': 'Wayne State University, 3901 Chrysler Dr, Detroit, MI, 48201, USA. Electronic address: tjovanovic@med.wayne.edu.'}, {'ForeName': 'Israel', 'Initials': 'I', 'LastName': 'Liberzon', 'Affiliation': 'Texas A&M University, 8447 Riverside Parkway, Bryan, TX, 77808-3260, USA. Electronic address: liberzon@tamu.edu.'}, {'ForeName': 'Douglas E', 'Initials': 'DE', 'LastName': 'Williamson', 'Affiliation': 'Duke University School of Medicine, Department of Psychiatry and Behavioral Sciences, 40 Duke Medicine Circle, Durham, NC, 27710, USA; Durham Veterans Administration Medical Center and VA Mid-Atlantic MIRECC, 508 Fulton Street, Durham, NC, 27705, USA. Electronic address: douglas.williamson@duke.edu.'}, {'ForeName': 'Col Jeffrey S', 'Initials': 'CJS', 'LastName': 'Yarvis', 'Affiliation': 'Carl R. Darnall Army Medical Center, Department of Behavioral Health, 36065 Santa Fe Ave., Fort Hood, TX, 76544, USA. Electronic address: jeffrey.s.yarvis.mil@mail.mil.'}, {'ForeName': 'Katherine A', 'Initials': 'KA', 'LastName': 'Dondanville', 'Affiliation': 'University of Texas Health Science Center at San Antonio, Department of Psychiatry and Behavioral Sciences, 7703 Floyd Curl Dr., San Antonio, TX, 78229, USA. Electronic address: Dondanville@uthscsa.edu.'}, {'ForeName': 'Stacey', 'Initials': 'S', 'LastName': 'Young-McCaughan', 'Affiliation': 'University of Texas Health Science Center at San Antonio, Department of Psychiatry and Behavioral Sciences, 7703 Floyd Curl Dr., San Antonio, TX, 78229, USA. Electronic address: youngs1@uthscsa.edu.'}, {'ForeName': 'Terence M', 'Initials': 'TM', 'LastName': 'Keane', 'Affiliation': 'VA Boston Healthcare System, National Center for PTSD (116B-2), 150 South Huntington Avenue, Boston, MA, 02130, USA; Boston University School of Medicine, Department of Psychiatry, 720 Harrison Avenue, Room 906, Boston, MA, 02118, USA. Electronic address: Terry.Keane@va.gov.'}, {'ForeName': 'Alan L', 'Initials': 'AL', 'LastName': 'Peterson', 'Affiliation': 'University of Texas Health Science Center at San Antonio, Department of Psychiatry and Behavioral Sciences, 7703 Floyd Curl Dr., San Antonio, TX, 78229, USA; South Texas Veterans Health Care System, Research and Development Service, 7400 Merton Minter, San Antonio, TX, 78229, USA; University of Texas at San Antonio, Department of Psychology, One UTSA Circle, San Antonio, TX, 78249, USA. Electronic address: petersona3@uthscsa.edu.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Psychoneuroendocrinology,['10.1016/j.psyneuen.2020.104749'] 1871,32555986,Autonomic function may not modulate irisin release in healthy adults: findings from a randomized cross-over study.,"OBJECTIVE Autonomic nervous system, especially the sympathetic nervous system, may stimulate the expression of peroxisome proliferator-activated receptor γ coactivator-1α, which regulates irisin. This study aimed to explore whether there was any association between autonomic function as assessed by heart rate related indices and irisin release following acute exercise. SUBJECTS AND METHODS Seventeen healthy adults were asked to perform an incremental exhaustive cycling as well as an incremental exhaustive running separately on different days. Heart rate was monitored, and blood samples were collected before, immediately, 10-, and 60-minutes post-exercise. Serum irisin was measured using ELISA kit. RESULTS Markers for autonomic function, such as heart rate at rest, peak, or recovery, heart rate reserve, heart rate recovery, and chronotropic index, were comparable between cycling and running (all P > 0.10). Irisin was increased immediately following both exercise. No significant association was observed between heart rate at rest, peak, or recovery and irisin level at the corresponding time-point, as well as between heart rate reserve, heart rate recovery, or chronotropic index and exercise induced irisin release, with or without controlling for age, body mass index, and glucose (all P > 0.10). CONCLUSIONS Autonomic function might not be associated with irisin release in healthy adults. Arch Endocrinol Metab. 2020;64(3):201-4.",2020,"No significant association was observed between heart rate at rest, peak, or recovery and irisin level at the corresponding time-point, as well as between heart rate reserve, heart rate recovery, or chronotropic index and exercise induced irisin release, with or without controlling for age, body mass index, and glucose (all P > 0.10). ","['Seventeen healthy adults', 'healthy adults']",[],"['heart rate at rest, peak, or recovery, heart rate reserve, heart rate recovery, and chronotropic index', 'heart rate reserve, heart rate recovery, or chronotropic index and exercise induced irisin release, with or without controlling for age, body mass index, and glucose', 'heart rate at rest, peak, or recovery and irisin level', 'Heart rate', 'Irisin', 'Serum irisin']","[{'cui': 'C0450331', 'cui_str': '17'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}]",[],"[{'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0443144', 'cui_str': 'At rest'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0229671', 'cui_str': 'Serum'}]",17.0,0.0253477,"No significant association was observed between heart rate at rest, peak, or recovery and irisin level at the corresponding time-point, as well as between heart rate reserve, heart rate recovery, or chronotropic index and exercise induced irisin release, with or without controlling for age, body mass index, and glucose (all P > 0.10). ","[{'ForeName': 'Shanhu', 'Initials': 'S', 'LastName': 'Qiu', 'Affiliation': ""Department of Endocrinology,Shenzhen People's Hospital; The Second Clinical Medical College of Jinan University; The First Affiliated Hospital of Southern University of Science and Technology, Shenzhen, China.""}, {'ForeName': 'Edit', 'Initials': 'E', 'LastName': 'Bosnyák', 'Affiliation': 'Division of Sports and Rehabilitation Medicine, Ulm University Medical Center, Ulm, Germany.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Zügel', 'Affiliation': 'Division of Sports and Rehabilitation Medicine, Ulm University Medical Center, Ulm, Germany.'}, {'ForeName': 'Jürgen Michael', 'Initials': 'JM', 'LastName': 'Steinacker', 'Affiliation': 'Division of Sports and Rehabilitation Medicine, Ulm University Medical Center, Ulm, Germany.'}, {'ForeName': 'Uwe', 'Initials': 'U', 'LastName': 'Schumann', 'Affiliation': 'Division of Sports and Rehabilitation Medicine, Ulm University Medical Center, Ulm, Germany.'}]",Archives of endocrinology and metabolism,['10.20945/2359-3997000000243'] 1872,32559602,Efficacy and safety of vilaprisan in women with uterine fibroids: Data from the phase 2b randomized controlled trial ASTEROID 2.,"OBJECTIVE To assess the efficacy of vilaprisan compared with placebo in the management of the symptoms of uterine fibroids (UF), with a secondary objective to provide a descriptive comparison with ulipristal acetate. STUDY DESIGN The randomized, parallel-group, double-blind, placebo- and active-controlled, multicenter ASTEROID 2 trial assessed the efficacy and safety of vilaprisan versus placebo and ulipristal acetate for two 12-week treatment periods in women with ≥1 UF experiencing heavy menstrual bleeding (HMB). The primary endpoint compared the efficacy of vilaprisan with placebo at 12 weeks, assessed as the absence of bleeding/spotting by bleeding diary. Secondary endpoints compared the efficacy of vilaprisan with ulipristal acetate. Results of the first 12-week treatment period are reported here. RESULTS Women (mean age 42.5 years) were enrolled from 1 June 2015. At baseline, mean menstrual blood loss per 28 days was 214.1 mL and the volume of the three largest UF was 106.2 mL. In total, 155 women completed the initial 12-week treatment period. Complete absence of bleeding/spotting until the end of the 12-week treatment period was achieved by 62.9 % of women receiving vilaprisan versus 0.0 % with placebo (p < .001); 55.4 % of women treated with ulipristal acetate reported absence of bleeding/spotting. The predefined HMB response (<80 mL and >50 % reduction from baseline during the last 28 days of treatment) was observed in 95.7 % of subjects treated with vilaprisan and 86.5 % of subjects treated with ulipristal acetate. Vilaprisan and ulipristal acetate treatment reduced the sum of the volume of the three largest UF by 29.9 % and 23.8 %, respectively, whereas an increase of 6.3 % was observed in the placebo group. No safety concerns, including multiple laboratory parameters, were identified. CONCLUSION Daily administration of vilaprisan 2 mg induced amenorrhea, controlled bleeding, decreased UF size, and was well tolerated in women with HMB associated with UF. CLINICAL TRIAL REGISTRATION ClinicalTrials.gov number: NCT02465814 https://clinicaltrials.gov/ct2/show/NCT02465814.",2020,"Vilaprisan and ulipristal acetate treatment reduced the sum of the volume of the three largest UF by 29.9 % and 23.8 %, respectively, whereas an increase of 6.3 % was observed in the placebo group.","['women with ≥1 UF experiencing heavy menstrual bleeding (HMB', 'women with uterine fibroids', 'Women (mean age 42.5 years) were enrolled from 1 June 2015', '155 women completed the initial 12-week treatment period']","['Vilaprisan and ulipristal acetate', 'ulipristal acetate', 'vilaprisan versus placebo and ulipristal acetate', 'vilaprisan', 'placebo']","['mean menstrual blood loss', 'HMB response', 'Efficacy and safety', 'absence of bleeding/spotting by bleeding diary', 'Complete absence of bleeding/spotting', 'efficacy and safety', 'amenorrhea, controlled bleeding, decreased UF size', 'efficacy of vilaprisan', 'efficacy of vilaprisan with ulipristal acetate', 'absence of bleeding/spotting']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0042133', 'cui_str': 'Leiomyoma'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0025323', 'cui_str': 'Menorrhagia'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C4508937', 'cui_str': 'vilaprisan'}, {'cui': 'C2723461', 'cui_str': 'Ulipristal acetate'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0694689', 'cui_str': 'Menstrual blood'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0002453', 'cui_str': 'Amenorrhea'}, {'cui': 'C0149533', 'cui_str': 'Control of hemorrhage'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0042133', 'cui_str': 'Leiomyoma'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C4508937', 'cui_str': 'vilaprisan'}, {'cui': 'C2723461', 'cui_str': 'Ulipristal acetate'}]",155.0,0.413833,"Vilaprisan and ulipristal acetate treatment reduced the sum of the volume of the three largest UF by 29.9 % and 23.8 %, respectively, whereas an increase of 6.3 % was observed in the placebo group.","[{'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Gemzell-Danielsson', 'Affiliation': ""Department of Women's and Children's Health, Division of Obstetrics and Gynecology, Karolinska Institutet, and Karolinska University Hospital, S-171 76, Stockholm, Sweden. Electronic address: Kristina.Gemzell@ki.se.""}, {'ForeName': 'Oskari', 'Initials': 'O', 'LastName': 'Heikinheimo', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Helsinki and Helsinki University Hospital, PO Box 140, 00029-HUS, Helsinki, Finland. Electronic address: oskari.heikinheimo@helsinki.fi.'}, {'ForeName': 'Janos', 'Initials': 'J', 'LastName': 'Zatik', 'Affiliation': 'Szent Anna Szuleszeti, Nogyogyaszati es Ultrahang Magan Rendelo, 48 Szent Anna utca, Debrecen, Hungary. Electronic address: jzatik@yahoo.com.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Poka', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Debrecen, Nagyerdei krt. 98, 4032, Debrecen, Hungary. Electronic address: pokar@med.unideb.hu.'}, {'ForeName': 'Tomasz', 'Initials': 'T', 'LastName': 'Rechberger', 'Affiliation': 'II Department of Gynecology, Medical University of Lublin, Racławickie 1 Street, 20-059, Lublin, Poland. Electronic address: rechbergt@yahoo.com.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Hudecek', 'Affiliation': 'Department of Obstetrics and Gynecology, Brno University Hospital and Masaryk University Medical School, Jihlavská 20, CZ - 625 00, Brno, Czech Republic. Electronic address: hudecek.robert@fnbrno.cz.'}, {'ForeName': 'Kathrin', 'Initials': 'K', 'LastName': 'Petersdorf', 'Affiliation': 'Bayer AG, Müllerstraße 178, 13342, Berlin, Germany. Electronic address: Kathrin.petersdorf@bayer.com.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Ramirez', 'Affiliation': 'Syneos Health, Frankfurter StraBe 233 Triforum, Haus C1 Neu-Isenburg, 63263, Germany. Electronic address: francisco.ramirez1.ext@bayer.com.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Faustmann', 'Affiliation': 'Bayer AG, Müllerstraße 178, 13342, Berlin, Germany. Electronic address: thomas.faustmann@bayer.com.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Groettrup-Wolfers', 'Affiliation': 'Bayer AG, Müllerstraße 178, 13342, Berlin, Germany. Electronic address: Esther.groettrup-wolfers@bayer.com.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Seitz', 'Affiliation': 'Bayer AG, Müllerstraße 178, 13342, Berlin, Germany. Electronic address: Christian.seitz@bayer.com.'}]","European journal of obstetrics, gynecology, and reproductive biology",['10.1016/j.ejogrb.2020.05.043'] 1873,32559644,Compensation of stochastic time-continuous perturbations during walking in healthy young adults: An analysis of the structure of gait variability.,"BACKGROUND During everyday locomotion, we cope with various internal or external perturbations (e.g. uneven surface). Uncertainty exists on how unpredictable external perturbations increase noise within the motor system and if they are compensated by employing covariation of the limb joints or rather due to decreased sensitivity of an altered posture. RESEARCH QUESTION Do continuous stochastic perturbations affect the structure of gait variability in young and healthy adults? METHODS In a cross-over study, gait kinematics of 21 healthy young sports students were registered during treadmill walking with and without continuous stochastic perturbations. Using the TNC method, the following aspects were analyzed: (a) the sensitivity of body posture to perturbations ('tolerance') decreasing gait variability, (b) the unstructured motor 'noise' increasing gait variability and (c) the amount of 'covariation' of the limb joints. RESULTS Compared to normal walking, gait variability was significantly increased (p < .001) during walking with perturbations. The negative effect of noise was partly compensated by improved 'covariation' of leg joints (p < .001). The aspect 'tolerance' had a small effect on increasing gait variability during stance phase (p < .001) and decreasing gait variability during swing phase (p < .001). SIGNIFICANCE Increased motor noise due to external perturbations is partly compensated by improved covariation of the limb joints. However, the effect of an altered posture slightly affects gait variability. Further studies should focus on different populations (e.g. older participants) to see if they use the same mechanism (improved covariation) to compensate for stochastic perturbations.",2020,"The aspect 'tolerance' had a small effect on increasing gait variability during stance phase (p < .001) and decreasing gait variability during swing phase (p < .001). ","['young and healthy adults', '21 healthy young sports students', 'healthy young adults']",['treadmill walking with and without continuous stochastic perturbations'],"[""sensitivity of body posture to perturbations ('tolerance') decreasing gait variability, (b) the unstructured motor 'noise' increasing gait variability and (c) the amount of 'covariation' of the limb joints"", 'gait variability', 'normal walking, gait variability', ""covariation' of leg joints""]","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0038039', 'cui_str': 'Sport'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0332453', 'cui_str': 'Disruption'}]","[{'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C1262869', 'cui_str': 'Body position'}, {'cui': 'C0332453', 'cui_str': 'Disruption'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}]",21.0,0.0319459,"The aspect 'tolerance' had a small effect on increasing gait variability during stance phase (p < .001) and decreasing gait variability during swing phase (p < .001). ","[{'ForeName': 'Monique', 'Initials': 'M', 'LastName': 'Koch', 'Affiliation': 'Institute of Sports Science, Friedrich Schiller University of Jena, Jena, Germany. Electronic address: mq.koch@gmx.de.'}, {'ForeName': 'Nils', 'Initials': 'N', 'LastName': 'Eckardt', 'Affiliation': 'Department of Sport and Movement Science, Institute of Sport Science, Carl von Ossietzky University of Oldenburg, Oldenburg, Germany; Department for Exercise & Health, Institute of Sport Science, Leibniz University Hannover, Hannover, Germany. Electronic address: nils.eckardt@uni-oldenburg.de.'}, {'ForeName': 'Astrid', 'Initials': 'A', 'LastName': 'Zech', 'Affiliation': 'Institute of Sports Science, Friedrich Schiller University of Jena, Jena, Germany. Electronic address: astrid.zech@uni-jena.de.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Hamacher', 'Affiliation': 'Institute of Sports Science, Friedrich Schiller University of Jena, Jena, Germany. Electronic address: daniel.hamacher@uni-jena.de.'}]",Gait & posture,['10.1016/j.gaitpost.2020.05.040'] 1874,32559656,Can theory of mind be improved? Positive expectations cause better theory of mind performance in a community sample.,"BACKGROUND AND OBJECTIVES Theory of Mind (ToM) deficits are present in several mental disorders and closely related to problems in social functioning and lower quality of life. While several trainings are aimed at improving ToM performance, it is unknown whether positive expectations on a persons' ToM performance might cause better ToM achievement. METHODS Participants (n = 131) first completed a mock ToM test and were then randomly assigned to either receive standardized positive, negative or no feedback on their ToM performance. Secondly, their expectations on their own ToM performance were assessed. Thirdly, ToM was assessed using the Movie Task for the Assessment of Social Cognition (MASC). RESULTS Participants who received positive feedback resulted in positive expectations on their ToM performance and showed enhanced ToM performance, whereas negative feedback did not lead to negative expectations and negative expectations did not affect a change in ToM performance. LIMITATIONS In the present exploratory study, the effect of positive expectations on ToM performance was assessed in a community sample. Thus, the study should be replicated in a clinical sample for more in-depth results. CONCLUSIONS ToM performance could be enhanced by inducing positive expectations on one's ToM performance, whereas negative feedback had no effect. The present study suggest that interventions that focus on strengthening positive expectations on one's ToM performance could enhance the efficacy of present ToM training methods.",2020,"RESULTS Participants who received positive feedback resulted in positive expectations on their ToM performance and showed enhanced ToM performance, whereas negative feedback did not lead to negative expectations and negative expectations did not affect a change in ToM performance. ",['Participants (n\xa0'],"['standardized positive, negative or no feedback on their ToM performance']","['Movie Task for the Assessment of Social Cognition (MASC', 'enhanced ToM performance', 'ToM performance']",[],"[{'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0935573', 'cui_str': 'Theory of Mind'}]","[{'cui': 'C0681495', 'cui_str': 'Movies'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0935573', 'cui_str': 'Theory of Mind'}]",131.0,0.0319971,"RESULTS Participants who received positive feedback resulted in positive expectations on their ToM performance and showed enhanced ToM performance, whereas negative feedback did not lead to negative expectations and negative expectations did not affect a change in ToM performance. ","[{'ForeName': 'Laura M-L', 'Initials': 'LM', 'LastName': 'Dorn', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Philipps-University, Marburg, Germany. Electronic address: laura.dorn@staff.uni-marburg.de.'}, {'ForeName': 'Winfried', 'Initials': 'W', 'LastName': 'Rief', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Philipps-University, Marburg, Germany.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Mehl', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Philipps-University, Marburg, Germany; Department of Social Work and Health, Frankfurt University of Applied Sciences, Germany.'}]",Journal of behavior therapy and experimental psychiatry,['10.1016/j.jbtep.2020.101577'] 1875,32559669,A novel digital health intervention to improve patient engagement to stimulants in adult ADHD in the primary care setting: Preliminary findings from an open label study.,"AIMS We piloted the effectiveness and acceptability of a novel text messaging-based (SMS) digital health intervention aimed at addressing the previously documented poor rate of patient engagement in stimulant treatment in the primary care setting. METHODS 117 adults ages 18-55 from primary care and psychiatric practices who were prescribed a stimulant medication for ADHD treatment received the SMS intervention. Comparators were age-, race-, and sex-matched patients from the same health care organization's electronic medical record who had been prescribed stimulant medications over a similar time period. Using documented prescription records, we determined whether patients had timely prescription refills. RESULTS Ninety-six percent (N = 112) of participants completed our a priori metric of patient engagement consisting of 37 days of the SMS program. Eighty-one percent of participants refilled their index prescriptions in a timely manner compared to only 36% of patients receiving treatment as usual (OR=7.54, 95% CI: 4.46, 12.77; p<0.001). We found no significant interaction between prescribing source (non-psychiatry vs. psychiatry) and intervention group (SMS vs. treatment as usual). CONCLUSIONS These data suggest that an ADHD-centric, digital health intervention using text messaging significantly improves patient engagement in stimulant treatment in adults with ADHD.",2020,"We found no significant interaction between prescribing source (non-psychiatry vs. psychiatry) and intervention group (SMS vs. treatment as usual). ","[""Comparators were age-, race-, and sex-matched patients from the same health care organization's electronic medical record who had been prescribed stimulant medications over a similar time period"", 'adults with ADHD', 'adult ADHD in the primary care setting', '117 adults ages 18-55 from primary care and psychiatric practices who were prescribed a stimulant medication for ADHD treatment received the']","['SMS intervention', 'digital health intervention', 'novel text messaging-based (SMS) digital health intervention']",['patient engagement'],"[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0034510', 'cui_str': 'Racial group'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0029237', 'cui_str': 'Organization'}, {'cui': 'C2362543', 'cui_str': 'Computer record of patient'}, {'cui': 'C2239117', 'cui_str': 'Prescription of drug'}, {'cui': 'C0002763', 'cui_str': 'Central stimulant'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C1948053', 'cui_str': 'Time periods'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C3508152', 'cui_str': 'Patient Engagement'}]",117.0,0.0801889,"We found no significant interaction between prescribing source (non-psychiatry vs. psychiatry) and intervention group (SMS vs. treatment as usual). ","[{'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Biederman', 'Affiliation': 'Clinical and Research Programs in Pediatric Psychopharmacology and Adult ADHD, Massachusetts General Hospital, Boston, MA, USA; Department of Psychiatry, Harvard Medical School, Boston, MA, USA. Electronic address: jbiederman@partners.org.'}, {'ForeName': 'Ronna', 'Initials': 'R', 'LastName': 'Fried', 'Affiliation': 'Clinical and Research Programs in Pediatric Psychopharmacology and Adult ADHD, Massachusetts General Hospital, Boston, MA, USA; Department of Psychiatry, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Maura', 'Initials': 'M', 'LastName': 'DiSalvo', 'Affiliation': 'Clinical and Research Programs in Pediatric Psychopharmacology and Adult ADHD, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Haley', 'Initials': 'H', 'LastName': 'Driscoll', 'Affiliation': 'Clinical and Research Programs in Pediatric Psychopharmacology and Adult ADHD, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Green', 'Affiliation': 'Clinical and Research Programs in Pediatric Psychopharmacology and Adult ADHD, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Itai', 'Initials': 'I', 'LastName': 'Biederman', 'Affiliation': 'Clinical and Research Programs in Pediatric Psychopharmacology and Adult ADHD, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'K Yvonne', 'Initials': 'KY', 'LastName': 'Woodworth', 'Affiliation': 'Clinical and Research Programs in Pediatric Psychopharmacology and Adult ADHD, Massachusetts General Hospital, Boston, MA, USA.'}, {'ForeName': 'Stephen V', 'Initials': 'SV', 'LastName': 'Faraone', 'Affiliation': 'Departments of Psychiatry and of Neuroscience and Physiology, SUNY Upstate Medical University, Syracuse, NY, USA.'}]",Psychiatry research,['10.1016/j.psychres.2020.113158'] 1876,32562747,Effects of an 8-week resistance training intervention on plantar flexor muscle quality and functional capacity in older women: A randomised controlled trial.,"The present study examined 8 weeks of resistance training and its effects on muscle quality measures, plantar flexor muscle strength, muscle thickness and functional capacity in older women. Moreover, we tested if changes in muscle quality were associated with functional capacity. Twenty-four older women (66.3 ± 5.8 years; 69.0 ± 3.0 kg; 25.3 ± 1.4 kg·m -2 ) were recruited to the study. After completion of the baseline assessment, participants were randomly assigned to either the resistance training (RET, n = 12) or an active control group (CTR, n = 12). Muscle quality was evaluated through muscle echo intensity (MQ EI ) and specific tension (MQ ST ). Muscle thickness, unilateral plantar flexor muscle strength and functional tests were evaluated at baseline and after the training period. After 8 weeks, both MQ EI and MQ ST did not respond to the intervention. Furthermore, significant changes in stair climb performance (P < 0.05) were not associated with plantar flexor-derived muscle quality (P > 0.05). Finally, significant gains in muscle hypertrophy were observed in the RET group (P < 0.01), while muscle strength failed to change significantly (P > 0.05). In conclusion, a resistance training program provided significant benefits in the stair climb test, unrelated to plantar flexor-derived muscle quality measures as previously demonstrated in quadriceps femoris.",2020,"Furthermore, significant changes in stair climb performance (P < 0.05) were not associated with plantar flexor-derived muscle quality (P > 0.05).","['older women', 'Twenty-four older women (66.3\u202f±\u202f5.8\u202fyears; 69.0\u202f±\u202f3.0\u202fkg; 25.3\u202f±\u202f1.4\u202fkg·m -2 ']","['8-week resistance training intervention', 'resistance training (RET, n\u202f=\u202f12) or an active control', 'resistance training']","['stair climb performance', 'Muscle quality', 'plantar flexor-derived muscle quality', 'muscle quality', 'plantar flexor muscle quality and functional capacity', 'Muscle thickness, unilateral plantar flexor muscle strength and functional tests', 'muscle hypertrophy', 'muscle strength', 'muscle echo intensity (MQ EI ) and specific tension (MQ ST ', 'muscle quality measures, plantar flexor muscle strength, muscle thickness and functional capacity']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C4517796', 'cui_str': '5.8'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517503', 'cui_str': '1.4'}]","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0389252', 'cui_str': 'RET protein, human'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0432601', 'cui_str': 'Stairs climbed'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0230463', 'cui_str': 'Structure of sole of foot'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0236033', 'cui_str': 'Muscle hypertrophy'}, {'cui': 'C0013520', 'cui_str': 'Doppler Echocardiography'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0233494', 'cui_str': 'Tension'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",24.0,0.0161992,"Furthermore, significant changes in stair climb performance (P < 0.05) were not associated with plantar flexor-derived muscle quality (P > 0.05).","[{'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Lopez', 'Affiliation': 'Exercise Medicine Research Institute, Edith Cowan University, Perth, Western Australia, Australia. Electronic address: p.lopezda@our.ecu.edu.au.'}, {'ForeName': 'Brendan James', 'Initials': 'BJ', 'LastName': 'Crosby', 'Affiliation': 'Exercise Medicine Research Institute, Edith Cowan University, Perth, Western Australia, Australia.'}, {'ForeName': 'Bruna Patrícia', 'Initials': 'BP', 'LastName': 'Robetti', 'Affiliation': 'Universidade de Caxias do Sul, Caxias do Sul, Rio Grande do Sul, Brazil.'}, {'ForeName': 'Douglas Jean Preussler', 'Initials': 'DJP', 'LastName': 'Turella', 'Affiliation': 'Centro Clínico UCS, Universidade de Caxias do Sul, Caxias do Sul, Rio Grande do Sul, Brazil.'}, {'ForeName': 'Thaís Andréia Schepa', 'Initials': 'TAS', 'LastName': 'Weber', 'Affiliation': 'Universidade de Caxias do Sul, Caxias do Sul, Rio Grande do Sul, Brazil.'}, {'ForeName': 'Morgana Lima', 'Initials': 'ML', 'LastName': 'de Oliveira', 'Affiliation': 'Universidade de Caxias do Sul, Caxias do Sul, Rio Grande do Sul, Brazil.'}, {'ForeName': 'Anderson', 'Initials': 'A', 'LastName': 'Rech', 'Affiliation': 'Universidade de Caxias do Sul, Caxias do Sul, Rio Grande do Sul, Brazil.'}]",Experimental gerontology,['10.1016/j.exger.2020.111003'] 1877,32562806,Impact of health warning labels on snack selection: An online experimental study.,"Excessive consumption of energy-dense food increases the risk of obesity, which in turn increases the risk of non-communicable diseases, including heart disease, type 2 diabetes and most non-smoking-related cancers. Health warning labels (HWLs) that communicate the adverse health consequences of excess energy consumption could reduce intake of energy-dense foods. The aim of the current study was to estimate the impact on selection of energy-dense snacks of (a) image-and-text HWLs (b) text-only HWLs and (c) calorie information. In a between-subjects, 3 (HWL: image-and-text, text-only, no label) x 2 (calorie information: present, absent), factorial experimental design, participants (N = 4134) were randomised to view a selection of energy-dense and non-energy-dense snacks with one of five label types or no label. The primary outcome was the proportion of participants selecting an energy-dense snack in a hypothetical vending machine task. The proportion of participants selecting an energy-dense snack was reduced in all label groups, relative to the no label group (no label: 59%; calories only: 54%; text-only HWL: 48%; text-only HWL with calories: 44%; image-and-text HWL: 37%; image-and-text HWL with calories: 38%). Compared to the no label group, participants were least likely to select an energy-dense snack in the image-and-text HWL group (OR = 0.46, 95%CI = 0.40, 0.54, p < 0.001). Health warning labels - particularly those including an image and text - have the potential to reduce selection of energy-dense snacks in an online setting. Their impact on selection and consumption in real-world settings awaits testing.",2020,"The proportion of participants selecting an energy-dense snack was reduced in all label groups, relative to the no label group (no label: 59%; calories only: 54%; text-only HWL: 48%; text-only HWL with calories: 44%; image-and-text HWL: 37%; image-and-text HWL with calories: 38%).","['participants (N\u202f=\u202f4,134', 'snack selection']","['energy-dense snacks of (a) image-and-text HWLs (b) text-only HWLs and (c) calorie information', 'health warning labels', 'energy-dense and non-energy-dense snacks with one of five label types or no label']","['proportion of participants selecting an energy-dense snack', 'proportion of participants selecting an energy-dense snack in a hypothetical vending machine task']","[{'cui': 'C0453863', 'cui_str': 'Snack food'}, {'cui': 'C0031222', 'cui_str': 'Personnel Selection'}]","[{'cui': 'C0439794', 'cui_str': 'Dense'}, {'cui': 'C0453863', 'cui_str': 'Snack food'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0439794', 'cui_str': 'Dense'}, {'cui': 'C0453863', 'cui_str': 'Snack food'}, {'cui': 'C0336779', 'cui_str': 'Machine'}]",4134.0,0.0769476,"The proportion of participants selecting an energy-dense snack was reduced in all label groups, relative to the no label group (no label: 59%; calories only: 54%; text-only HWL: 48%; text-only HWL with calories: 44%; image-and-text HWL: 37%; image-and-text HWL with calories: 38%).","[{'ForeName': 'Natasha', 'Initials': 'N', 'LastName': 'Clarke', 'Affiliation': 'Behaviour and Health Research Unit, Institute of Public Health, University of Cambridge, Cambridge, UK. Electronic address: ncc42@medschl.cam.ac.uk.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Pechey', 'Affiliation': 'Behaviour and Health Research Unit, Institute of Public Health, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Eleni', 'Initials': 'E', 'LastName': 'Mantzari', 'Affiliation': 'Behaviour and Health Research Unit, Institute of Public Health, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Anna K M', 'Initials': 'AKM', 'LastName': 'Blackwell', 'Affiliation': 'Tobacco and Alcohol Research Group, School of Psychological Science, University of Bristol, Bristol, UK.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'De-Loyde', 'Affiliation': 'Tobacco and Alcohol Research Group, School of Psychological Science, University of Bristol, Bristol, UK.'}, {'ForeName': 'Richard W', 'Initials': 'RW', 'LastName': 'Morris', 'Affiliation': 'Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Marcus R', 'Initials': 'MR', 'LastName': 'Munafò', 'Affiliation': 'Tobacco and Alcohol Research Group, School of Psychological Science, University of Bristol, Bristol, UK.'}, {'ForeName': 'Theresa M', 'Initials': 'TM', 'LastName': 'Marteau', 'Affiliation': 'Behaviour and Health Research Unit, Institute of Public Health, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Gareth J', 'Initials': 'GJ', 'LastName': 'Hollands', 'Affiliation': 'Behaviour and Health Research Unit, Institute of Public Health, University of Cambridge, Cambridge, UK.'}]",Appetite,['10.1016/j.appet.2020.104744'] 1878,32563609,"Safety and immunogenicity of experimental stand-alone trivalent, inactivated Sabin-strain polio vaccine formulations in healthy infants: A randomized, observer-blind, controlled phase 1/2 trial.","BACKGROUND To increase the global supply of affordable IPV vaccine, preferably using Sabin viruses to comply with GAPIII requirements, Takeda has assessed three dosages of a stand-alone sIPV. METHODS In this phase I/II study two cohorts of 40 adults and 60 toddlers, respectively, were initially assessed for safety after receiving high-dosage sIPV compared with placebo (adults) or Salk IPV (toddlers). A cohort of 240 infants was then enrolled and randomized (1:1:1:1) to receive low-, medium- or high-dosage sIPV, or a reference Salk IPV in a three-dose primary schedule at 6, 10 and 14 weeks of age. Parents completed safety diaries for 4 weeks after each dose, and immunogenicity was measured as neutralization antibody titers at baseline and four weeks after vaccination. RESULTS All vaccinations were generally well-tolerated and sIPV had a comparable safety profile to the control arm in adults or the reference Salk IPV vaccine in toddlers and infants. Infants displayed dosage-dependent immune responses to sIPV when assayed using Sabin strains, which were equivalent to the reference IPV in the high-dosage sIPV group for serotypes 1 and 2, but not for Sabin and Salk serotype 3. Seroconversion rates (SCR) of the low- and medium-dosage groups were significantly lower than the Salk IPV group for both Sabin and Salk serotypes 1 and type 2 (p < 0.05), with no significant differences for Salk or Sabin serotypes 3. Responses to sIPV, particularly to Sabin types 1 and 2, were higher in initially seronegative infants, indicating possible interference by maternally-derived antibodies. CONCLUSIONS A novel stand-alone Sabin-based IPV vaccine was well tolerated with an acceptable safety profile, but less immunogenic than reference Salk IPV at 6, 10 and 14 weeks of age for Salk serotypes 1 and 2, with apparent interference by maternal antibodies. Additional preclinical assessments will be made before any further clinical development.",2020,All vaccinations were generally well-tolerated and sIPV had a comparable safety profile to the control arm in adults or the reference Salk IPV vaccine in toddlers and infants.,"['240 infants', '40 adults and 60 toddlers', 'healthy infants']","['Salk IPV', 'experimental stand-alone trivalent, inactivated Sabin-strain polio vaccine formulations', 'placebo (adults) or Salk IPV (toddlers', 'low-, medium- or high-dosage sIPV, or a reference Salk IPV']","['safety diaries', 'neutralization antibody titers', 'Safety and immunogenicity', 'Seroconversion rates (SCR']","[{'cui': 'C4319600', 'cui_str': '240'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0682053', 'cui_str': 'Toddler'}]","[{'cui': 'C0718003', 'cui_str': 'Inactivated Poliovirus vaccine'}, {'cui': 'C0560204', 'cui_str': 'Does stand alone'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0032371', 'cui_str': 'Acute poliomyelitis'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0682053', 'cui_str': 'Toddler'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C0474643', 'cui_str': 'Antibody titer measurement'}, {'cui': 'C4042908', 'cui_str': 'Seroconversion'}]",240.0,0.09039,All vaccinations were generally well-tolerated and sIPV had a comparable safety profile to the control arm in adults or the reference Salk IPV vaccine in toddlers and infants.,"[{'ForeName': 'Jakob P', 'Initials': 'JP', 'LastName': 'Cramer', 'Affiliation': 'Takeda Pharmaceuticals International AG, Zurich, Switzerland.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Jimeno', 'Affiliation': 'Department of Infectious Diseases at Hospital del Niño Dr. José Renán Esquivel, Sistema Nacional de Investigación at SENACYT, Centro de Vacunación Internacional (Cevaxin), Panama City, Panama, USA.'}, {'ForeName': 'Htay Htay', 'Initials': 'HH', 'LastName': 'Han', 'Affiliation': 'Takeda Vaccines, Inc., Cambridge, USA. Electronic address: htay-htay.han@takeda.com.'}, {'ForeName': 'Stella', 'Initials': 'S', 'LastName': 'Lin', 'Affiliation': 'Takeda Vaccines, Inc., Cambridge, USA.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Hartmann', 'Affiliation': 'Takeda Pharmaceuticals International AG, Zurich, Switzerland.'}, {'ForeName': 'Astrid', 'Initials': 'A', 'LastName': 'Borkowski', 'Affiliation': 'Takeda Pharmaceuticals International AG, Zurich, Switzerland.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Sáez-Llorens', 'Affiliation': 'Department of Infectious Diseases at Hospital del Niño Dr. José Renán Esquivel, Sistema Nacional de Investigación at SENACYT, Centro de Vacunación Internacional (Cevaxin), Panama City, Panama, USA.'}]",Vaccine,['10.1016/j.vaccine.2020.05.081'] 1879,32447315,"Effect of flavour manipulation on ENDS (JUUL) users' experiences, puffing behaviour and nicotine exposure among US college students.","SIGNIFICANCE Electronic nicotine delivery system (ENDS) use has continued to increase exponentially among young people in the USA, with unique flavours being one of the most cited reasons for use. Yet, controlled studies examining the effects of restricting flavour are lacking. This study evaluates the impact of ENDS flavour manipulation on user's puffing behaviour, subjective experience, harm perception and nicotine exposure among college-aged ENDS users. METHODS JUUL users (n=30, age 18 to 24 years) attended two 60 min ad libitum ENDS use sessions (JUUL preferred flavour vs JUUL classic tobacco flavour) in a cross-over design. Puff topography and plasma nicotine concentration were measured, and participants completed subjective experience questionnaires. RESULTS Increases were observed on measures of satisfaction, taste, enjoyment, urges to vape/smoke, pleasure, product appeal and increased concentration following using the preferred flavour pod (p values <0.05). Compared with preferred flavour, participants in the tobacco flavour were less motivated to use it in the future (70.9 vs 19.1 scores, p<0.001), even if it was the only product on the market (75.8 vs 30.7 scores, p<0.001). While nicotine levels significantly increased in both conditions from pre to post session (p values <0.001), no significant differences were observed in nicotine boost levels or on puff topography parameters when comparing both flavour conditions. CONCLUSIONS This pilot study provides evidence that ENDS flavours have a substantial effect in enhancing young current ENDS users' experiences, product appeal and motivation to use the product in the future. It highlights that limiting flavours could play a potential role when designing strategic policies to reduce the appeal of ENDS use among young people.",2020,"RESULTS Increases were observed on measures of satisfaction, taste, enjoyment, urges to vape/smoke, pleasure, product appeal and increased concentration following using the preferred flavour pod (p values <0.05).","['US college students', 'college-aged ENDS users', 'JUUL users (n=30, age 18 to 24 years']","['flavour manipulation', 'ENDS flavour manipulation', 'Electronic nicotine delivery system (ENDS', 'attended two 60\u2009min ad libitum ENDS use sessions (JUUL preferred flavour vs JUUL classic tobacco flavour', 'ENDS flavours']","['Puff topography and plasma nicotine concentration', 'nicotine boost levels', 'satisfaction, taste, enjoyment, urges to vape/smoke, pleasure, product appeal and increased concentration']","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C3849993', 'cui_str': 'Electronic cigarette'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0682897', 'cui_str': 'Flavor Enhancers'}, {'cui': 'C0947647', 'cui_str': 'Manipulation'}, {'cui': 'C3849993', 'cui_str': 'Electronic cigarette'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0439658', 'cui_str': 'Classic'}, {'cui': 'C0040329', 'cui_str': 'Tobacco'}]","[{'cui': 'C1533107', 'cui_str': 'Puff - unit of product usage'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0039336', 'cui_str': 'Finding of sense of taste'}, {'cui': 'C0679105', 'cui_str': 'Pleasure'}, {'cui': 'C0291011', 'cui_str': 'VAPE protocol'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0205217', 'cui_str': 'Increased'}]",,0.0222113,"RESULTS Increases were observed on measures of satisfaction, taste, enjoyment, urges to vape/smoke, pleasure, product appeal and increased concentration following using the preferred flavour pod (p values <0.05).","[{'ForeName': 'Mayra', 'Initials': 'M', 'LastName': 'Vargas-Rivera', 'Affiliation': 'Epidemiology, Robert Stempel College of Public Health, Florida International University, Miami, Florida, USA.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Ebrahimi Kalan', 'Affiliation': 'Epidemiology, Robert Stempel College of Public Health, Florida International University, Miami, Florida, USA.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Ward-Peterson', 'Affiliation': 'Community Based Research Institute, Robert Stempel College of Public Health, Florida International University, Miami, Florida, USA.'}, {'ForeName': 'Olatokunbo', 'Initials': 'O', 'LastName': 'Osibogun', 'Affiliation': 'Epidemiology, Robert Stempel College of Public Health, Florida International University, Miami, Florida, USA.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'Epidemiology, Robert Stempel College of Public Health, Florida International University, Miami, Florida, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Brown', 'Affiliation': 'Family and Community Medicine, Florida International University College of Medicine, Miami, Florida, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Eissenberg', 'Affiliation': 'Psychology and Center for the Study of Tobacco Products, Virginia Commonwealth University, Richmond, Virginia, USA.'}, {'ForeName': 'Wasim', 'Initials': 'W', 'LastName': 'Maziak', 'Affiliation': 'Epidemiology, Robert Stempel College of Public Health, Florida International University, Miami, Florida, USA wmaziak@fiu.edu.'}]",Tobacco control,['10.1136/tobaccocontrol-2019-055551'] 1880,32563116,Screening and brief intervention for lower-risk drug use in primary care: A pilot randomized trial.,"AIMS The efficacy of screening and brief intervention for lower-risk drug use is unknown. This pilot study tested the efficacy of two brief interventions (BIs) for drug use compared to no BI in primary care patients with lower-risk drug use identified by screening. METHODS We randomly assigned participants identified by screening with Alcohol Smoking and Substance Involvement Screening Test (ASSIST) drug specific scores of 2 or 3 to: no BI, a brief negotiated interview (BNI), or an adaptation of motivational interviewing (MOTIV). Primary outcome was number of days use of main drug in the past 30 as determined by validated calendar method at 6 months. Analyses were performed using negative binomial regression adjusted for baseline use and main drug. RESULTS Of 142 eligible adults, 61(43 %) consented and were randomized. Participant characteristics were: mean age 41; 54 % male; 77 % black. Main drug was cannabis 70 %, cocaine 15 %, prescription opioid 10 %; 7% reported injection drug use and mean days use of main drug (of 30) was 3.4. At 6 months, 93 % completed follow-up and adjusted mean days use of main drug were 6.4 (no BI) vs 2.1 (BNI) (incidence rate ratio, IRR 0.33[0.15-0.74]) and 2.3 (MOTIV) (IRR 0.36[0.15-0.85]). CONCLUSIONS BI appears to have efficacy for preventing an increase in drug use in primary care patients with lower-risk use identified by screening. These findings raise the potential that less severe patterns of drug use in primary care may be uniquely amenable to brief intervention and warrant replication.",2020,"This pilot study tested the efficacy of two brief interventions (BIs) for drug use compared to no BI in primary care patients with lower-risk drug use identified by screening. ","['Of 142 eligible adults, 61(43 %) consented and were randomized', 'Participant characteristics were: mean age 41; 54 % male; 77 % black', 'lower-risk drug use in primary care', 'primary care patients with lower-risk drug use identified by screening', 'primary care patients with lower-risk use identified by screening']","['brief interventions (BIs', 'screening with Alcohol Smoking and Substance Involvement Screening Test (ASSIST) drug specific scores of 2 or 3 to: no BI, a brief negotiated interview (BNI), or an adaptation of motivational interviewing (MOTIV', 'screening and brief intervention']",['number of days use of main drug in the past 30 as determined by validated calendar method'],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0449889', 'cui_str': 'Drug used'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0042153', 'cui_str': 'utilization'}]","[{'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0439861', 'cui_str': 'Substance'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0871311', 'cui_str': 'Screening test'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0680727', 'cui_str': 'Mediation'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0000934', 'cui_str': 'Acclimation'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0035513', 'cui_str': 'Contraceptive rhythm method'}]",142.0,0.0558587,"This pilot study tested the efficacy of two brief interventions (BIs) for drug use compared to no BI in primary care patients with lower-risk drug use identified by screening. ","[{'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Bertholet', 'Affiliation': 'Addiction Medicine, Department of Psychiatry, Lausanne University Hospital and University of Lausanne, Bugnon 23A, Lausanne, 1011, Switzerland. Electronic address: Nicolas.Bertholet@chuv.ch.'}, {'ForeName': 'Seville', 'Initials': 'S', 'LastName': 'Meli', 'Affiliation': 'Upstream USA, Cambridge, MA 02140, USA.'}, {'ForeName': 'Tibor P', 'Initials': 'TP', 'LastName': 'Palfai', 'Affiliation': 'Department of Psychology, Boston University, 900 Commonwealth Avenue, Boston, MA 02215, USA. Electronic address: palfai@bu.edu.'}, {'ForeName': 'Debbie M', 'Initials': 'DM', 'LastName': 'Cheng', 'Affiliation': 'Department of Biostatistics, Boston University School of Public Health, Clinical Addiction Research and Education (CARE) Unit, Section of General Internal Medicine, Department of Medicine, and the Grayken Center for Addiction, Boston Medical Center and Boston University School of Medicine, Boston, MA 02118, USA. Electronic address: dmcheng@bu.edu.'}, {'ForeName': 'Daniel P', 'Initials': 'DP', 'LastName': 'Alford', 'Affiliation': 'Clinical Addiction Research and Education (CARE) Unit, Section of General Internal Medicine, Department of Medicine, and the Grayken Center for Addiction, Boston Medical Center and Boston University School of Medicine, Boston, MA 02118, USA. Electronic address: Dan.Alford@bmc.org.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Bernstein', 'Affiliation': 'Department of Community Health Sciences, Boston University School of Public Health, Boston, MA 02118, USA. Electronic address: jbernste@bu.edu.'}, {'ForeName': 'Jeffrey H', 'Initials': 'JH', 'LastName': 'Samet', 'Affiliation': 'Department of Community Health Sciences, Boston University School of Public Health, Boston, MA, USA, and Clinical Addiction Research and Education (CARE) Unit, Section of General Internal Medicine, Department of Medicine, and the Grayken Center for Addiction, Boston Medical Center and Boston University School of Medicine, Boston, MA 02118, USA. Electronic address: jsamet@bu.edu.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Lloyd-Travaglini', 'Affiliation': 'Data Coordinating Center, Boston University School of Public Health, Boston, MA 02118, USA. Electronic address: clloyd@bu.edu.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Saitz', 'Affiliation': 'Department of Community Health Sciences, Boston University School of Public Health, Boston, MA, USA, and Clinical Addiction Research and Education (CARE) Unit, Section of General Internal Medicine, Department of Medicine, and the Grayken Center for Addiction, Boston Medical Center and Boston University School of Medicine, Boston, MA 02118, USA. Electronic address: rsaitz@bu.edu.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2020.108001'] 1881,32563171,Adjunctive perampanel and myoclonic and absence seizures: Post hoc analysis of data from study 332 in patients with idiopathic generalized epilepsy.,"PURPOSE This post hoc analysis assessed the effects of adjunctive perampanel on myoclonic and absence seizure outcomes in patients (aged ≥12 years) with idiopathic generalized epilepsy (IGE) and generalized tonic-clonic seizures during the double-blind (up to 8 mg/day) and open-label extension (OLEx; up to 12 mg/day) phases of Study 332. METHODS Patients experiencing myoclonic and/or absence seizures during study baseline were included. Assessments for myoclonic and absence seizures included: median percent change in seizure frequency, number of seizure days and seizure-free days (all per 28 days), 50 % and 75 % responder rates, seizure-freedom rates, seizure worsening, and monitoring of treatment-emergent adverse events (TEAEs). RESULTS During the double-blind phase, myoclonic and/or absence seizures were reported in 47/163 and 60/163 patients, respectively. Median percent reductions in seizure frequency per 28 days from study baseline were 52.5% and 24.5% (myoclonic seizures) and 7.6 % and 41.2 % (absence seizures) for placebo and perampanel, respectively; seizure-freedom rates were 13.0 % and 16.7 % (myoclonic seizures) and 12.1 % and 22.2 % (absence seizures), respectively. During the OLEx phase, 46/138 and 52/138 patients experienced myoclonic and/or absence seizures, respectively. Responses during the double-blind phase were maintained during long-term (>104 weeks) adjunctive perampanel treatment. The frequency/type of TEAEs was consistent with the known safety profile of perampanel. CONCLUSION In this post hoc analysis, adjunctive perampanel was not associated with any overall worsening of absence seizures. Further research is needed to investigate the effect of adjunctive perampanel in IGE patients with myoclonic and/or absence seizures.",2020,"In this post hoc analysis, adjunctive perampanel was not associated with any overall worsening of absence seizures.","['and myoclonic and absence seizures', 'patients (aged ≥12 years) with idiopathic generalized epilepsy (IGE) and generalized tonic-clonic seizures during the double-blind (up to 8 mg/day) and open-label extension (OLEx; up to 12 mg/day) phases of Study 332', 'Patients experiencing myoclonic and/or absence seizures during study baseline were included', 'patients with idiopathic generalized epilepsy', 'IGE patients with myoclonic and/or absence seizures']","['Adjunctive perampanel', 'adjunctive perampanel', 'placebo']","['responder rates, seizure-freedom rates, seizure worsening, and monitoring of treatment-emergent adverse events (TEAEs', 'seizure frequency', 'overall worsening of absence seizures', 'myoclonic and/or absence seizures', 'seizure frequency, number of seizure days and seizure-free days', 'seizure-freedom rates', 'myoclonic and absence seizure outcomes']","[{'cui': 'C0014553', 'cui_str': 'Absence seizure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0270850', 'cui_str': 'Idiopathic generalized epilepsy'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0494475', 'cui_str': 'Tonic-clonic seizure'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C2698764', 'cui_str': 'perampanel'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0149775', 'cui_str': 'Fit frequency'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0014553', 'cui_str': 'Absence seizure'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1299590', 'cui_str': 'Seizure free'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.383148,"In this post hoc analysis, adjunctive perampanel was not associated with any overall worsening of absence seizures.","[{'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Brandt', 'Affiliation': 'Bethel Epilepsy Centre, Maraweg 21, 33617, Bielefeld, Germany. Electronic address: Christian.Brandt@mara.de.'}, {'ForeName': 'Robert T', 'Initials': 'RT', 'LastName': 'Wechsler', 'Affiliation': 'Idaho Comprehensive Epilepsy Center, 1499 West Hays St., Boise, ID, 83702, USA. Electronic address: rtw@idahoepilepsy.com.'}, {'ForeName': 'Terence J', 'Initials': 'TJ', 'LastName': ""O'Brien"", 'Affiliation': 'The Department of Neuroscience, The Central Clinical School, Monash University, The Alfred Centre, 99 Commercial Road, Melbourne, VIC, 3004, Australia; The Departments of Medicine, The Royal Melbourne Hospital, The University of Melbourne, Grattan St., Parkville, VIC, 3010, Australia. Electronic address: terence.obrien@monash.edu.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Patten', 'Affiliation': 'Eisai Ltd., Mosquito Way, Hatfield, Hertfordshire, AL10 9SN, UK. Electronic address: Anna_Patten@eisai.net.'}, {'ForeName': 'Manoj', 'Initials': 'M', 'LastName': 'Malhotra', 'Affiliation': 'Eisai Inc., 100 Tice Blvd, Woodcliff Lake, NJ, 07677, USA. Electronic address: Manoj_Malhotra@eisai.com.'}, {'ForeName': 'Leock Y', 'Initials': 'LY', 'LastName': 'Ngo', 'Affiliation': 'Eisai Inc., 100 Tice Blvd, Woodcliff Lake, NJ, 07677, USA. Electronic address: Stella_Ngo@eisai.com.'}, {'ForeName': 'Bernhard J', 'Initials': 'BJ', 'LastName': 'Steinhoff', 'Affiliation': 'Kork Epilepsy Centre, Landstraße 1, 77694, Kehl-Kork, Germany. Electronic address: BSteinhoff@epilepsiezentrum.de.'}]",Seizure,['10.1016/j.seizure.2020.06.011'] 1882,32563173,Impact of childhood adversity on network reconfiguration dynamics during working memory in hypogonadal women.,"Many women with no history of cognitive difficulties experience executive dysfunction during menopause. Significant adversity during childhood negatively impacts executive function into adulthood and may be an indicator of women at risk of a mid-life cognitive decline. Previous studies have indicated that alterations in functional network connectivity underlie these negative effects of childhood adversity. There is growing evidence that functional brain networks are not static during executive tasks; instead, such networks reconfigure over time. Optimal dynamics are necessary for efficient executive function; while too little reconfiguration is insufficient for peak performance, too much reconfiguration (supra-optimal reconfiguration) is also maladaptive and associated with poorer performance. Here we examined the impact of adverse childhood experiences (ACEs) on network flexibility, a measure of dynamic reconfiguration, during a letter n-back task within three networks that support executive function: frontoparietal, salience, and default mode networks. Several animal and human subject studies have suggested that childhood adversity exerts lasting effects on executive function via serotonergic mechanisms. Tryptophan depletion (TD) was used to examine whether serotonin function drives ACE effects on network flexibility. We hypothesized that ACE would be associated with higher flexibility (supra-optimal flexibility) and that TD would further increase this measure. Forty women underwent functional imaging at two time points in this double-blind, placebo controlled, crossover study. Participants also completed the Penn Conditional Exclusion Test, a task assessing abstraction and mental flexibility. The effects of ACE and TD were evaluated using generalized estimating equations. ACE was associated with higher flexibility across networks (frontoparietal β = 0.00748, D = 2.79, p = 0.005; salience β = 0.00679, D = 3.02, p = 0.003; and default mode β = 0.00910, D = 3.53, p = 0.0004). While there was no interaction between ACE and TD, active TD increased network flexibility in both ACE groups in comparison to sham depletion (frontoparietal β = 0.00489, D = 2.15, p = 0.03; salience β = 0.00393, D = 1.91, p = 0.06; default mode β = 0.00334, D = 1.73, p = 0.08). These results suggest that childhood adversity has lasting impacts on dynamic reconfiguration of functional brain networks supporting executive function and that decreasing serotonin levels may exacerbate these effects.",2020,"While there was no interaction between ACE and TD, active TD increased network flexibility in both ACE groups in comparison to sham depletion (frontoparietal β = 0.00489, D =","['Forty women underwent', 'hypogonadal women', 'Many women with no history of cognitive difficulties experience executive dysfunction during menopause']","['ACE', 'Tryptophan depletion (TD', 'functional imaging', 'placebo']","['ACE and TD, active TD increased network flexibility']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332122', 'cui_str': 'No history of'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C2748208', 'cui_str': 'Executive dysfunction'}, {'cui': 'C0587112', 'cui_str': 'During menopause'}]","[{'cui': 'C0050385', 'cui_str': 'AC protocol'}, {'cui': 'C0041249', 'cui_str': 'Tryptophan'}, {'cui': 'C0333668', 'cui_str': 'Depletion'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0050385', 'cui_str': 'AC protocol'}, {'cui': 'C0041249', 'cui_str': 'Tryptophan'}, {'cui': 'C0333668', 'cui_str': 'Depletion'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}]",40.0,0.0712399,"While there was no interaction between ACE and TD, active TD increased network flexibility in both ACE groups in comparison to sham depletion (frontoparietal β = 0.00489, D =","[{'ForeName': 'Sheila', 'Initials': 'S', 'LastName': 'Shanmugan', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA; Penn PROMOTES Research on Sex and Gender in Health, University of Pennsylvania, Philadelphia, PA, USA. Electronic address: sheilashanmugan@gmail.com.'}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Cao', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Theodore D', 'Initials': 'TD', 'LastName': 'Satterthwaite', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Mary D', 'Initials': 'MD', 'LastName': 'Sammel', 'Affiliation': 'Penn PROMOTES Research on Sex and Gender in Health, University of Pennsylvania, Philadelphia, PA, USA; Department of Biostatistics and Epidemiology, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA; Obstetrics and Gynecology, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Arian', 'Initials': 'A', 'LastName': 'Ashourvan', 'Affiliation': 'Department of Bioengineering, University of Pennsylvania, Philadelphia, PA, USA; Department of Neurology, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Danielle S', 'Initials': 'DS', 'LastName': 'Bassett', 'Affiliation': 'Department of Bioengineering, University of Pennsylvania, Philadelphia, PA, USA; Department of Neurology, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA; Department of Physics & Astronomy, University of Pennsylvania, Philadelphia, PA, USA; Department of Electrical & Systems Engineering, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Kosha', 'Initials': 'K', 'LastName': 'Ruparel', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Ruben C', 'Initials': 'RC', 'LastName': 'Gur', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'C Neill', 'Initials': 'CN', 'LastName': 'Epperson', 'Affiliation': 'Department of Psychiatry, Anschutz Medical Campus, University of Colorado, Aurora, CO USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Loughead', 'Affiliation': 'Department of Psychiatry, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, PA, USA.'}]",Psychoneuroendocrinology,['10.1016/j.psyneuen.2020.104710'] 1883,32567140,"Physical activity, sitting time and sleep duration before and during pregnancy and pregnancy outcomes: A prospective panel study.","AIMS AND OBJECTIVES To examine how changes in physical activity, sitting time and sleep duration through pre-, mid- and late pregnancy are in association with Caesarean section, medically indicated Caesarean section and small for gestational age. BACKGROUND While circadian activities could change throughout pregnancy, studies exploring the effect of change in those activities on pregnancy outcomes remain limited. DESIGN This study applied a prospective panel design. METHODS A self-reported questionnaire was used to assess the three activities before and during pregnancy and was administered three times from August 2015-July 2017. Multiple logistic regression models were used. The analysis included 488, 477 and 455 participants in the models for Caesarean section, medically indicated Caesarean section and small for gestational age, respectively. This study followed the STROBE guidelines. RESULTS The mean age of participants was 32.18 years, and more than half (54.90%) were primiparous. Sleep duration of >8 hr/day before pregnancy and experiencing a decrease in mid-pregnancy was a risk factor for Caesarean section and medically indicated Caesarean section. Sitting ≥8 hr/weekday in pre-, mid- and late pregnancy had a protective effect for Caesarean section and medically indicated Caesarean section. Sitting <8 hr in mid-pregnancy and experiencing a decrease in late pregnancy was a risk factor for small-for-gestational-age infants. Physical activity was not significantly related to pregnancy outcomes. CONCLUSION Sleep duration of 7-8 hr and sitting time of more than 8 hr/day seem beneficial for women both before and during pregnancy. RELEVANCE TO CLINICAL PRACTICE Health professionals could assess pregnant women or those intending to become pregnant regarding their sleep and sitting behaviour and provide relevant interventions.",2020,"Physical activity was not significantly related to pregnancy outcomes. ","['The mean age of participants was 32.18 years, and more than half (54.90%) were primiparous', 'The analysis included 488, 477, and 455 participants in the models for caesarean section, medically-indicated caesarean section, and small for gestational age, respectively']",['Sitting'],"['Physical Activity, Sitting Time, and Sleep Duration', 'Physical activity', 'physical activity, sitting time, and sleep duration through pre-, mid-, and late pregnancy in association with caesarean section, medically-indicated caesarean section, and small for gestational age', 'Sleep duration', 'protective effect for caesarean section and medically-indicated caesarean section', 'late pregnancy']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0033150', 'cui_str': 'Para 1'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0235991', 'cui_str': 'Small for gestational age'}]","[{'cui': 'C0037216', 'cui_str': 'SITS'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0424574', 'cui_str': 'Duration of sleep'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0444598', 'cui_str': 'Mid'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0235991', 'cui_str': 'Small for gestational age'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",,0.0188153,"Physical activity was not significantly related to pregnancy outcomes. ","[{'ForeName': 'Shiue-Shan', 'Initials': 'SS', 'LastName': 'Weng', 'Affiliation': 'School of Nursing, Institute of Community Health Care, National Yang-Ming University, Taipei, Taiwan.'}, {'ForeName': 'Yu-Hsiang', 'Initials': 'YH', 'LastName': 'Lee', 'Affiliation': 'Department of Obstetrics and Gynecology, Taipei Tzu Chi Hospital, Taipei, Taiwan.'}, {'ForeName': 'Li-Yin', 'Initials': 'LY', 'LastName': 'Chien', 'Affiliation': 'School of Nursing, Institute of Community Health Care, National Yang-Ming University, Taipei, Taiwan.'}]",Journal of clinical nursing,['10.1111/jocn.15388'] 1884,32563787,Tolerability and effectiveness of povidone-iodine or mupirocin versus saline sinus irrigations for chronic rhinosinusitis.,"OBJECTIVES The role of topical anti-infectives in acute exacerbations of chronic rhinosinusitis is controversial. Povidone-iodine is an anti-bacterial and anti-viral that is affordable and available over-the-counter and may demonstrate advantages over mupirocin as a sinus irrigation therapy. The objective was to compare povidone-iodine or mupirocin versus saline sinus irrigations for sinusitis exacerbations in post-surgery subjects as well as to assess tolerability of povidone-iodine sinus irrigations. MATERIALS AND METHODS This was a prospective single-blinded (clinician only) randomized controlled trial. Subjects were post-surgery with acute exacerbations of chronic rhinosinusitis and gram-positive bacteria on culture. They received povidone-iodine, mupirocin, or saline sinus irrigations, twice daily for 30 days. Outcomes were post-treatment culture negativity (primary) and Sinonasal Outcome Test-20 and Lund-Kennedy endoscopic score change (secondary). RESULTS Of the 62 subjects analyzed, post-treatment culture negativity rate was higher in the MUP (14/20, 70%) group compared to the PI (9/21, 43%) and SAL (9/19, 47%) groups, although this was not significant (p = 0.29). Povidone-iodine sinus irrigations at the 1% concentration were very well-tolerated, similar to saline irrigations. There were no significant differences in Sinonasal Outcome Test-20 score (povidone-iodine -0.3 [-0.6, 0.05] vs. mupirocin -0.3 [-0.7, 0.05] vs. saline -0.4 [-0.8, 0.05]; p = 0.86) or Lund-Kennedy endoscopic score (povidone-iodine -3.5 [-7, -0.5] vs. mupirocin -2 [-4, 2] vs. saline -3 [-5, 0]; p = 0.45) change. No serious adverse effects were reported. CONCLUSIONS In patients who have had prior sinus surgery with acute exacerbations of CRS and gram-positive bacteria on culture, mupirocin sinus irrigations achieved a better post-treatment culture ""control"" rate compared to saline and povidone-iodine. In addition, 1% povidone-iodine solution was well-tolerated as a sinus irrigation and may represent a feasible method for temporarily disinfecting the sinonasal cavity of bacteria and viruses such as COVID-19.",2020,"There were no significant differences in Sinonasal Outcome Test-20 score (povidone-iodine -0.3 [-0.6, 0.05] vs. mupirocin -0.3","['patients who have had prior sinus surgery with acute exacerbations of CRS and gram-positive bacteria on culture, mupirocin sinus irrigations', 'sinusitis exacerbations in post-surgery subjects', 'chronic rhinosinusitis', '62 subjects analyzed', 'Subjects were post-surgery with acute exacerbations of chronic rhinosinusitis and gram-positive bacteria on culture']","['povidone-iodine, mupirocin, or saline sinus irrigations', 'Povidone-iodine sinus irrigations', 'saline -3', 'povidone-iodine solution', 'saline and povidone-iodine', 'Povidone-iodine', 'povidone-iodine or mupirocin versus saline sinus irrigations', 'topical anti-infectives']","['Lund-Kennedy endoscopic score', 'Tolerability and effectiveness', 'Sinonasal Outcome Test-20 score', 'culture negativity rate', 'culture negativity (primary) and Sinonasal Outcome Test-20 and Lund-Kennedy endoscopic score change (secondary', 'serious adverse effects']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0748725', 'cui_str': 'Sinus operation'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0018154', 'cui_str': 'Gram-positive bacteria'}, {'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0085259', 'cui_str': 'Mupirocin'}, {'cui': 'C0016169', 'cui_str': 'Fistula'}, {'cui': 'C0022100', 'cui_str': 'Irrigation'}, {'cui': 'C0037199', 'cui_str': 'Sinusitis'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}]","[{'cui': 'C0032857', 'cui_str': 'Povidone-Iodine'}, {'cui': 'C0085259', 'cui_str': 'Mupirocin'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0016169', 'cui_str': 'Fistula'}, {'cui': 'C0022100', 'cui_str': 'Irrigation'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0332237', 'cui_str': 'Topical'}]","[{'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C5197691', 'cui_str': 'SNOT-20'}, {'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",,0.208361,"There were no significant differences in Sinonasal Outcome Test-20 score (povidone-iodine -0.3 [-0.6, 0.05] vs. mupirocin -0.3","[{'ForeName': 'Victoria S', 'Initials': 'VS', 'LastName': 'Lee', 'Affiliation': 'Department of Otolaryngology - Head and Neck Surgery, University of Washington, Box 356515, Seattle, WA 98195, United States of America. Electronic address: vlee39@uic.edu.'}, {'ForeName': 'Paul S', 'Initials': 'PS', 'LastName': 'Pottinger', 'Affiliation': 'Department of Medicine, Division of Allergy & Infectious Diseases, University of Washington, 1959 NE Pacific St, PO Box 356130, Courier BB-302, Seattle, WA 98195, United States of America.'}, {'ForeName': 'Greg E', 'Initials': 'GE', 'LastName': 'Davis', 'Affiliation': 'Department of Otolaryngology - Head and Neck Surgery, University of Washington, Box 356515, Seattle, WA 98195, United States of America.'}]",American journal of otolaryngology,['10.1016/j.amjoto.2020.102604'] 1885,32563846,Depression history as a predictor of outcomes during buprenorphine-naloxone treatment of prescription opioid use disorder.,"BACKGROUND In the multi-site Prescription Opioid Addiction Treatment Study (POATS), the best predictor of successful opioid use outcome was lifetime diagnosis of major depressive disorder. The primary aim of this secondary analysis of data from POATS was to empirically assess two explanations for this counterintuitive finding. METHODS The POATS study was a national, 10-site randomized controlled trial (N = 360 enrolled in the 12-week buprenorphine-naloxone maintenance treatment phase) sponsored by the NIDA Clinical Trials Network. We evaluated how the presence of a history of depression influences opioid use outcome (negative urine drug assays). Using adjusted logistic regression models, we tested the hypotheses that 1) a reduction in depressive symptoms and 2) greater motivation and engagement in treatment account for the association between depression history and good treatment outcome. RESULTS Although depressive symptoms decreased significantly throughout treatment (p <.001), this improvement was not associated with opioid outcomes (aOR = 0.98, ns). Reporting a goal of opioid abstinence at treatment entry was also not associated with outcomes (aOR = 1.39, ns); however, mutual-help group participation was associated with good treatment outcomes (aOR = 1.67, p <.05). In each of these models, lifetime major depressive disorder remained associated with good outcomes (aORs = 1.63-1.82, ps = .01-.055). CONCLUSIONS Findings are consistent with the premise that greater engagement in treatment is associated with good opioid outcomes. Nevertheless, depression history continues to be associated with good opioid outcomes in adjusted models. More research is needed to understand how these factors could improve treatment outcomes for those with opioid use disorder.",2020,"Although depressive symptoms decreased significantly throughout treatment (p <.001), this improvement was not associated with opioid outcomes (aOR = 0.98, ns).","['prescription opioid use disorder', '360 enrolled in the 12-week', 'maintenance treatment phase) sponsored by the NIDA Clinical Trials Network']",['buprenorphine-naloxone'],"['lifetime major depressive disorder', 'depressive symptoms']","[{'cui': 'C0033080', 'cui_str': 'Prescription'}, {'cui': 'C4324621', 'cui_str': 'Opioid use disorder'}, {'cui': 'C4319607', 'cui_str': '360'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0068218', 'cui_str': 'N-nitrosoiminodiacetic acid'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}]","[{'cui': 'C1169989', 'cui_str': 'Buprenorphine- and naloxone-containing product'}]","[{'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]",360.0,0.0809725,"Although depressive symptoms decreased significantly throughout treatment (p <.001), this improvement was not associated with opioid outcomes (aOR = 0.98, ns).","[{'ForeName': 'Andrew D', 'Initials': 'AD', 'LastName': 'Peckham', 'Affiliation': 'Department of Psychiatry, McLean Hospital and Harvard Medical School, Belmont, MA, USA. Electronic address: adpeckham@mclean.harvard.edu.'}, {'ForeName': 'Margaret L', 'Initials': 'ML', 'LastName': 'Griffin', 'Affiliation': 'Department of Psychiatry, McLean Hospital and Harvard Medical School, Belmont, MA, USA.'}, {'ForeName': 'R Kathryn', 'Initials': 'RK', 'LastName': 'McHugh', 'Affiliation': 'Department of Psychiatry, McLean Hospital and Harvard Medical School, Belmont, MA, USA.'}, {'ForeName': 'Roger D', 'Initials': 'RD', 'LastName': 'Weiss', 'Affiliation': 'Department of Psychiatry, McLean Hospital and Harvard Medical School, Belmont, MA, USA.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2020.108122'] 1886,32563847,Longitudinal analysis of alcohol use and intimate partner violence perpetration among men with HIV in northern Vietnam.,"BACKGROUND Alcohol use is a known risk factor for male-perpetrated intimate partner violence (IPV), although few studies have been conducted globally and among men with HIV (MWH). We estimated the longitudinal effects of alcohol use on IPV perpetration among MWH. METHODS This study is a secondary analysis of randomized controlled trial data among male and female antiretroviral treatment patients with hazardous alcohol use in Thai Nguyen, Vietnam. Analyses were restricted to male participants who were married/cohabitating (N = 313). Alcohol use was assessed as proportion days alcohol abstinent, heavy drinking, and alcohol use disorder (AUD) using the Timeline Followback and Mini International Neuropsychiatric Interview questionnaire. Multilevel modeling was used to estimate the effects of higher versus lower average alcohol use on IPV perpetration (between-person effects) and the effects of time-specific deviations in alcohol use on IPV perpetration (within-person effects). RESULTS Participants with higher average proportion days alcohol abstinent had decreased odds of IPV perpetration (adjusted Odds Ratio [aOR] = 0.43, p = 0.03) and those with higher average heavy drinking and AUD had increased odds of IPV perpetration (Heavy drinking: aOR = 1.05, p = 0.002; AUD: aOR = 4.74, p < 0.0001). Time-specific increases in proportion days alcohol abstinent were associated with decreased odds of IPV perpetration (aOR = 0.39, p = 0.02) and time-specific increases in AUD were associated with increased odds of IPV perpetration (aOR = 2.95, p = 0.001). Within-person effects for heavy drinking were non-significant. CONCLUSIONS Alcohol use is associated with IPV perpetration among Vietnamese men with HIV. In this context, AUD and frequent drinking are stronger correlates of IPV perpetration as compared to heavy drinking.",2020,"Within-person effects for heavy drinking were non-significant. CONCLUSIONS Alcohol use is associated with IPV perpetration among Vietnamese men with HIV.","['men with HIV in northern Vietnam', 'men with HIV (MWH', 'Vietnamese men with HIV', 'male participants who were married/cohabitating (N = 313', 'male and female antiretroviral treatment patients with hazardous alcohol use in Thai Nguyen, Vietnam', 'male-perpetrated intimate partner violence (IPV']",[],"['proportion days alcohol abstinent, heavy drinking, and alcohol use disorder (AUD) using the Timeline Followback and Mini International Neuropsychiatric Interview questionnaire', 'time-specific increases in AUD', 'Time-specific increases in proportion days alcohol abstinent', 'IPV perpetration']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0042658', 'cui_str': 'Vietnam'}, {'cui': 'C0042660', 'cui_str': 'Vietnamese language'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0024841', 'cui_str': 'Marriage'}, {'cui': 'C4517707', 'cui_str': '313'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0599685', 'cui_str': 'Antiretroviral-containing product'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0039724', 'cui_str': 'Thai language'}, {'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}]",[],"[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0457801', 'cui_str': 'Non - drinker'}, {'cui': 'C0439539', 'cui_str': 'Heavy (weight)'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0001956', 'cui_str': 'Alcohol use disorder'}, {'cui': 'C0145943', 'cui_str': 'TimeLine'}, {'cui': 'C4505426', 'cui_str': 'Mini International Neuropsychiatric Interview'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}]",313.0,0.0196213,"Within-person effects for heavy drinking were non-significant. CONCLUSIONS Alcohol use is associated with IPV perpetration among Vietnamese men with HIV.","[{'ForeName': 'Rebecca B', 'Initials': 'RB', 'LastName': 'Hershow', 'Affiliation': 'University of North Carolina at Chapel Hill Gillings School of Global Public Health, 135 Dauer Drive, 302 Rosenau Hall, Chapel Hill, NC, 27599, USA. Electronic address: rhershow@live.unc.edu.'}, {'ForeName': 'H Luz McNaughton', 'Initials': 'HLM', 'LastName': 'Reyes', 'Affiliation': 'University of North Carolina at Chapel Hill Gillings School of Global Public Health, 135 Dauer Drive, 302 Rosenau Hall, Chapel Hill, NC, 27599, USA.'}, {'ForeName': 'Tran Viet', 'Initials': 'TV', 'LastName': 'Ha', 'Affiliation': 'UNC Project Vietnam, Yen Hoa Health Clinic, Lot E2, Duong Dinh Nghe Street, Hanoi, Viet Nam.'}, {'ForeName': 'Geetanjali', 'Initials': 'G', 'LastName': 'Chander', 'Affiliation': 'Johns Hopkins University Bloomberg School of Public Health, 615 N. Wolfe Street, Baltimore, MD, 21205, USA; Johns Hopkins University School of Medicine, 600 N. Wolfe Street, Baltimore, MD, 21205, USA.'}, {'ForeName': 'Nguyen Vu Tuyet', 'Initials': 'NVT', 'LastName': 'Mai', 'Affiliation': 'UNC Project Vietnam, Yen Hoa Health Clinic, Lot E2, Duong Dinh Nghe Street, Hanoi, Viet Nam.'}, {'ForeName': 'Teerada', 'Initials': 'T', 'LastName': 'Sripaipan', 'Affiliation': 'University of North Carolina at Chapel Hill Gillings School of Global Public Health, 135 Dauer Drive, 302 Rosenau Hall, Chapel Hill, NC, 27599, USA.'}, {'ForeName': 'Constantine', 'Initials': 'C', 'LastName': 'Frangakis', 'Affiliation': 'Johns Hopkins University Bloomberg School of Public Health, 615 N. Wolfe Street, Baltimore, MD, 21205, USA; Johns Hopkins University School of Medicine, 600 N. Wolfe Street, Baltimore, MD, 21205, USA.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Dowdy', 'Affiliation': 'Johns Hopkins University Bloomberg School of Public Health, 615 N. Wolfe Street, Baltimore, MD, 21205, USA; Johns Hopkins University School of Medicine, 600 N. Wolfe Street, Baltimore, MD, 21205, USA.'}, {'ForeName': 'Carl', 'Initials': 'C', 'LastName': 'Latkin', 'Affiliation': 'Johns Hopkins University Bloomberg School of Public Health, 615 N. Wolfe Street, Baltimore, MD, 21205, USA; Johns Hopkins University School of Medicine, 600 N. Wolfe Street, Baltimore, MD, 21205, USA.'}, {'ForeName': 'Heidi E', 'Initials': 'HE', 'LastName': 'Hutton', 'Affiliation': 'Johns Hopkins University School of Medicine, 600 N. Wolfe Street, Baltimore, MD, 21205, USA.'}, {'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'Pettifor', 'Affiliation': 'University of North Carolina at Chapel Hill Gillings School of Global Public Health, 135 Dauer Drive, 302 Rosenau Hall, Chapel Hill, NC, 27599, USA.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Maman', 'Affiliation': 'University of North Carolina at Chapel Hill Gillings School of Global Public Health, 135 Dauer Drive, 302 Rosenau Hall, Chapel Hill, NC, 27599, USA.'}, {'ForeName': 'Vivian F', 'Initials': 'VF', 'LastName': 'Go', 'Affiliation': 'University of North Carolina at Chapel Hill Gillings School of Global Public Health, 135 Dauer Drive, 302 Rosenau Hall, Chapel Hill, NC, 27599, USA.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2020.108098'] 1887,32564260,"Pertuzumab, trastuzumab, and docetaxel for Chinese patients with previously untreated HER2-positive locally recurrent or metastatic breast cancer (PUFFIN): a phase III, randomized, double-blind, placebo-controlled study.","PURPOSE The Chinese bridging study PUFFIN (NCT02896855) aimed to assess consistency of efficacy with CLEOPATRA (NCT00567190), investigating pertuzumab with trastuzumab and docetaxel versus placebo, trastuzumab, and docetaxel in patients with previously untreated HER2-positive locally recurrent or metastatic breast cancer. METHODS Patients were randomized 1:1, stratified by visceral/non-visceral disease and hormone receptor status. The primary endpoint was investigator-assessed progression-free survival (PFS). Secondary endpoints included objective response rate (in patients with measurable baseline disease), overall survival, and safety. The consistency threshold for PFS (hazard ratio [HR] < 0.81) (maintaining ≥ 50% of the risk reduction determined in CLEOPATRA [HR 0.62]) determined the target sample size (n = 240). RESULTS Two hundred forty-three patients were randomized. Median PFS was 14.5 months in the pertuzumab arm (95% confidence interval [CI] 12.5, 18.6) and 12.4 months in the placebo arm (95% CI 10.4, 12.7) in the intention-to-treat population (HR: 0.69 [95% CI 0.49, 0.99]). Objective responses were recorded in 83/105 (79.0%) and 67/97 (69.1%) patients, respectively. Grade ≥ 3 adverse events (70.5% and 69.2%, respectively) and serious adverse events (19.7% and 19.2%, respectively) were similar across both arms. No heart failure cases or symptomatic left ventricular ejection fraction declines were reported. CONCLUSIONS PUFFIN met its primary objective. Overall, efficacy data were consistent with CLEOPATRA. Safety was consistent with the known pertuzumab safety profile. PUFFIN adds to the totality of data with pertuzumab in previously untreated HER2-positive locally recurrent or metastatic breast cancer and supports the favorable benefit-risk profile of pertuzumab in Chinese patients TRIAL REGISTRATION: ClinicalTrials.gov, NCT02896855, registered 7 September 2016.",2020,"Median PFS was 14.5 months in the pertuzumab arm (95% confidence interval [CI] 12.5, 18.6) and 12.4 months in the placebo arm (95% CI 10.4, 12.7) in the intention-to-treat population (HR: 0.69 [95% CI 0.49, 0.99]).","['Chinese patients with previously untreated HER2-positive locally recurrent or metastatic breast cancer (PUFFIN', 'Two hundred forty-three patients were randomized', 'Patients were randomized 1:1, stratified by visceral/non-visceral disease and hormone receptor status', 'patients with previously untreated HER2-positive locally recurrent or metastatic breast cancer']","['Pertuzumab, trastuzumab, and docetaxel', 'pertuzumab', 'trastuzumab and docetaxel versus placebo, trastuzumab, and docetaxel', 'placebo']","['investigator-assessed progression-free survival (PFS', 'Median PFS', 'Grade\u2009≥\u20093 adverse events', 'heart failure cases or symptomatic left ventricular ejection fraction declines', 'measurable baseline disease), overall survival, and safety', 'serious adverse events', 'objective response rate', 'Objective responses']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0069515', 'cui_str': 'Oncogene protein HER-2/neu'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0278488', 'cui_str': 'Breast cancer stage IV'}, {'cui': 'C1002208', 'cui_str': 'Fratercula'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0450368', 'cui_str': '43'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0442045', 'cui_str': 'Visceral'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0449443', 'cui_str': 'Receptor status'}]","[{'cui': 'C1328025', 'cui_str': 'pertuzumab'}, {'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0018017', 'cui_str': 'Goal'}]",243.0,0.608416,"Median PFS was 14.5 months in the pertuzumab arm (95% confidence interval [CI] 12.5, 18.6) and 12.4 months in the placebo arm (95% CI 10.4, 12.7) in the intention-to-treat population (HR: 0.69 [95% CI 0.49, 0.99]).","[{'ForeName': 'Binghe', 'Initials': 'B', 'LastName': 'Xu', 'Affiliation': 'National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences, and Peking Union Medical College, Beijing, China. xubinghe@medmail.com.cn.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'The Cancer Center, The First Hospital of Jilin University, Jilin, China.'}, {'ForeName': 'Qingyuan', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': 'Harbin Medical University, Harbin, China.'}, {'ForeName': 'Zhimin', 'Initials': 'Z', 'LastName': 'Shao', 'Affiliation': 'Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Qiao', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences, and Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Xiaojia', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Zhejiang Cancer Hospital, Hangzhou City, China.'}, {'ForeName': 'Huiping', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Beijing Cancer Hospital, Beijing, China.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Sun', 'Affiliation': 'Cancer Hospital of China Medical University, Liaoning Cancer Hospital & Institute, Liaoning, China.'}, {'ForeName': 'Yongmei', 'Initials': 'Y', 'LastName': 'Yin', 'Affiliation': 'Jiangsu Province Hospital, Nanjing, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Zheng', 'Affiliation': 'West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Jifeng', 'Initials': 'J', 'LastName': 'Feng', 'Affiliation': 'Jiangsu Cancer Hospital, Nanjing, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Roche (China) Holding Ltd, Shanghai, China.'}, {'ForeName': 'Guiyuan', 'Initials': 'G', 'LastName': 'Lei', 'Affiliation': 'Roche Products Limited, Welwyn Garden City, UK.'}, {'ForeName': 'Eleonora', 'Initials': 'E', 'LastName': 'Restuccia', 'Affiliation': 'F. Hoffmann-La Roche Ltd, Basel, Switzerland.'}]",Breast cancer research and treatment,['10.1007/s10549-020-05728-w'] 1888,32564804,An RCT of Fecal Immunochemical Test Colorectal Cancer Screening in Veterans Without Recent Primary Care.,"INTRODUCTION The use of screening can prevent death from colorectal cancer, yet people without regular healthcare visits may not realize the benefits of this preventive intervention. The objective of this study was to determine the effectiveness of a mailed screening invitation or mailed fecal immunochemical test in increasing colorectal cancer screening uptake in veterans without recent primary care encounters. STUDY DESIGN Three-arm pragmatic randomized trial. SETTING/PARTICIPANTS Participants were screening-eligible veterans aged 50-75 years, without a recent primary care visit who accessed medical services at the Corporal Michael J. Crescenz Veteran Affairs Medical Center between January 1, 2017, and July 31, 2017. All data were analyzed from March 1, 2018, to July 31, 2018. INTERVENTION Participants were randomized to (1) usual opportunistic screening during a healthcare visit (n=260), (2) mailed invitation to screen and reminder phone calls (n=261), or (3) mailed fecal immunochemical test outreach plus reminder calls (n=61). MAIN OUTCOME MEASURES The main outcome under investigation was the completion of colorectal cancer screening within 6 months after randomization. RESULTS Of 782 participants in the trial, 53.9% were aged 60-75 years and 59.7% were African American. The screening rate was higher in the mailed fecal immunochemical test group (26.1%) compared with usual care (5.8%) (rate difference=20.3%, 95% CI=14.3%, 26.3%; RR=4.52, 95% CI=2.7, 7.7) or screening invitation (7.7%) (rate difference=18.4%, 95% CI=12.2%, 24.6%; RR=3.4, 95% CI=2.1, 5.4). Screening completion rates were similar between invitation and usual care (rate difference=1.9%, 95% CI= -2.4%, 6.2%; RR=1.3, 95% CI=0.7, 2.5). CONCLUSIONS Mailed fecal immunochemical test screening promotes colorectal cancer screening participation among veterans without a recent primary care encounter. Despite the addition of reminder calls, an invitation letter was no more effective in screening participation than screening during outpatient appointments. TRIAL REGISTRATION This study is registered at clinicaltrials.gov NCT02584998.",2020,"Screening completion rates were similar between invitation and usual care (rate difference=1.9%, 95% CI= -2.4%, 6.2%; RR=1.3, 95% CI=0.7, 2.5). ","['782 participants in the trial, 53.9% were aged 60-75 years and 59.7% were African American', 'Veterans Without Recent Primary Care', 'Participants were screening-eligible veterans aged 50-75 years, without a recent primary care visit who accessed medical services at the Corporal Michael J. Crescenz Veteran Affairs Medical Center between January 1, 2017, and July 31, 2017', 'veterans without a recent primary care encounter', 'veterans without recent primary care encounters']","['usual opportunistic screening during a healthcare visit (n=260), (2) mailed invitation to screen and reminder phone calls (n=261), or (3) mailed fecal immunochemical test outreach plus reminder calls (n=61', 'mailed screening invitation or mailed fecal immunochemical test']","['screening invitation', 'Screening completion rates', 'completion of colorectal cancer screening', 'screening rate']","[{'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C4521398', 'cui_str': 'US Military enlisted E4'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}]","[{'cui': 'C0422389', 'cui_str': 'Opportunistic screening'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0024492', 'cui_str': 'Mail'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}]",,0.289727,"Screening completion rates were similar between invitation and usual care (rate difference=1.9%, 95% CI= -2.4%, 6.2%; RR=1.3, 95% CI=0.7, 2.5). ","[{'ForeName': 'Matthew A', 'Initials': 'MA', 'LastName': 'Goldshore', 'Affiliation': 'Corporal Michael J. Crescenz VA Medical Center, Philadelphia, Pennsylvania; Department of Surgery, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania. Electronic address: matthew.goldshore@pennmedicine.upenn.edu.'}, {'ForeName': 'Shivan J', 'Initials': 'SJ', 'LastName': 'Mehta', 'Affiliation': 'Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Woodrow', 'Initials': 'W', 'LastName': 'Fletcher', 'Affiliation': 'Corporal Michael J. Crescenz VA Medical Center, Philadelphia, Pennsylvania.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Tzanis', 'Affiliation': 'Corporal Michael J. Crescenz VA Medical Center, Philadelphia, Pennsylvania.'}, {'ForeName': 'Chyke A', 'Initials': 'CA', 'LastName': 'Doubeni', 'Affiliation': 'Center for Health Equity and Community Engagement Research, Mayo Clinic, Rochester, Minnesota; Department of Family Medicine, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'E Carter', 'Initials': 'EC', 'LastName': 'Paulson', 'Affiliation': 'Corporal Michael J. Crescenz VA Medical Center, Philadelphia, Pennsylvania; Department of Surgery, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.'}]",American journal of preventive medicine,['10.1016/j.amepre.2020.02.014'] 1889,32565344,"Immunogenicity, safety and inter-lot consistency of a meningococcal conjugate vaccine (MenACYW-TT) in adolescents and adults: A Phase III randomized study.","BACKGROUND MenACYW-TT is an investigational quadrivalent (serogroups A, C, W and Y) meningococcal conjugate vaccine that is being developed for protection against invasive meningococcal disease. METHODS In this Phase 3, blinded, randomized study, 3344 meningococcal vaccine-naïve 10-55-year-olds were randomized (3:3:3:2) to receive one of three lots of MenACYW-TT or licensed quadrivalent meningococcal conjugate vaccine, MCV4-DT (NCT02842853). Antibody titers were assessed by human and rabbit complement serum bactericidal antibody assays. The co-primary objectives were to demonstrate lot-to-lot consistency of MenACYW-TT by the between-lot geometric mean titer ratios (GMTR) at Day 30, and non-inferiority of Day 30 vaccine seroresponses (titers ≥ 1:16 if pre-vaccination titers < 1:8, or ≥ 4-fold increase if pre-vaccination titers ≥ 1:8) with MenACYW-TT vs MCV4-DT. Further objectives included safety and immunogenicity. RESULTS Lot consistency was demonstrated for all three lots, with GMTRs ranging from 0.87 to 1.1. The proportion of participants achieving seroresponse in the MenACYW-TT group (data pooled from the 3 lots) was non-inferior to MCV4-DT (A: 74% vs 55%; C: 89% vs 48%; W: 80% vs 61%; Y: 91% vs 73%, respectively). MenACYW-TT and MCV4-DT had similar safety profiles; no safety concerns were identified. CONCLUSIONS The study met both co-primary endpoints, demonstrating lot-to-lot consistency and non-inferiority of MenACYW-TT vs MCV4-DT in adolescents and adults.",2020,"RESULTS Lot consistency was demonstrated for all three lots, with GMTRs ranging from 0.87 to 1.1.","['3344 meningococcal vaccine-naïve 10-55-year-olds', 'adolescents and adults']","['meningococcal conjugate vaccine (MenACYW-TT', 'MCV4-DT', 'MenACYW-TT or licensed quadrivalent meningococcal conjugate vaccine, MCV4-DT (NCT02842853']","['Immunogenicity, safety and inter-lot consistency', 'Antibody titers', 'safety and immunogenicity']","[{'cui': 'C0700144', 'cui_str': 'Meningococcus vaccine'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C1660580', 'cui_str': 'Meningococcal conjugate vaccine'}, {'cui': 'C0023636', 'cui_str': 'Licenses'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0474643', 'cui_str': 'Antibody titer measurement'}]",3344.0,0.232694,"RESULTS Lot consistency was demonstrated for all three lots, with GMTRs ranging from 0.87 to 1.1.","[{'ForeName': 'Mandeep S', 'Initials': 'MS', 'LastName': 'Dhingra', 'Affiliation': 'Global Clinical Sciences, Sanofi Pasteur, Swiftwater, PA 18370, USA. Electronic address: MandeepSingh.Dhingra@sanofi.com.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Peterson', 'Affiliation': 'J Lewis Research, Salt Lake City, UT 84109, USA. Electronic address: jpeterson@foothillfamilyclinic.com.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Hedrick', 'Affiliation': 'Kentucky Pediatric and Adult Research, Bardstown, KY 40004, USA. Electronic address: jhedrick@bardstowncable.net.'}, {'ForeName': 'Judy', 'Initials': 'J', 'LastName': 'Pan', 'Affiliation': 'Global Biostatistical Sciences, Sanofi Pasteur, Swiftwater, PA 18370, USA. Electronic address: judy.pan@sanofi.com.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Neveu', 'Affiliation': 'Global Pharmacovigilance, Sanofi Pasteur, Swiftwater, PA 18370, USA. Electronic address: david.neveu@sanofi.com.'}, {'ForeName': 'Emilia', 'Initials': 'E', 'LastName': 'Jordanov', 'Affiliation': 'Global Clinical Sciences, Sanofi Pasteur, Swiftwater, PA 18370, USA. Electronic address: emilia.jordanov@sanofi.com.'}]",Vaccine,['10.1016/j.vaccine.2020.06.013'] 1890,31885339,Transurethral holmium laser resection and transurethral electrocision combined with intravesical epirubicin within 24 hours postoperatively for treatment of bladder cancer.,"OBJECTIVE To investigate the efficacy and safety of transurethral holmium laser resection (THOLR) and transurethral electrocision (TUR) combined with intravesical epirubicin within 24 hours postoperatively for treatment of non-muscular invasive bladder cancer. METHODS A total of 218 consecutive patients who were newly diagnosed with bladder cancer were enrolled in this prospective study from July 2014 to December 2017. The patients were randomly divided into THOLR and TUR groups. All patients received intravesical epirubicin (30 mg dissolved in 5% glucose solution) within 24 hours postoperatively. The operation time, blood loss, rate of obturator reflex, hospitalization time, catheterization time, complications, and recurrence were analyzed. RESULTS Operation, hospitalization, and catheterization times were significantly greater in the TUR group than in the THOLR group. The rates of blood loss and intraoperative obturator reflex were also significantly greater in the TUR group. There were no significant differences in complications, recurrence rate survival, or recurrence-free survival between the two groups, with the exception of bladder perforation rate. CONCLUSIONS THOLR and TUR combined with intravesical epirubicin within 24 hours postoperatively were both safe and effective for treatment of bladder tumor; however, patients who undergo THOLR might experience more rapid recovery.",2020,"There were no significant differences in complications, recurrence rate survival, or recurrence-free survival between the two groups, with the exception of bladder perforation rate. ","['218 consecutive patients who were newly diagnosed with bladder cancer were enrolled in this prospective study from July 2014 to December 2017', 'non-muscular invasive bladder cancer', 'bladder cancer']","['transurethral holmium laser resection (THOLR) and transurethral electrocision (TUR) combined with intravesical epirubicin', 'TUR', 'THOLR and TUR combined with intravesical epirubicin', 'Transurethral holmium laser resection and transurethral electrocision combined with intravesical epirubicin', 'intravesical epirubicin']","['Operation, hospitalization, and catheterization times', 'efficacy and safety', 'operation time, blood loss, rate of obturator reflex, hospitalization time, catheterization time, complications, and recurrence', 'complications, recurrence rate survival, or recurrence-free survival', 'rates of blood loss and intraoperative obturator reflex']","[{'cui': 'C4517647', 'cui_str': '218'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0005684', 'cui_str': 'Malignant tumor of urinary bladder'}, {'cui': 'C0033522', 'cui_str': 'Prospective Studies'}, {'cui': 'C0442025', 'cui_str': 'Muscular'}, {'cui': 'C1827293', 'cui_str': 'Carcinoma of urinary bladder, invasive'}]","[{'cui': 'C0205497', 'cui_str': 'Transurethral approach'}, {'cui': 'C0441085', 'cui_str': 'Holmium:YAG laser device'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0442124', 'cui_str': 'Intravesical approach'}, {'cui': 'C0014582', 'cui_str': 'Epirubicin'}]","[{'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0007430', 'cui_str': 'Catheterization'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0182021', 'cui_str': 'Obturator'}, {'cui': 'C0034929', 'cui_str': 'Reflex'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C2919733', 'cui_str': 'Surviving free of recurrence of neoplastic disease'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}]",218.0,0.0160123,"There were no significant differences in complications, recurrence rate survival, or recurrence-free survival between the two groups, with the exception of bladder perforation rate. ","[{'ForeName': 'Jiawei', 'Initials': 'J', 'LastName': 'Lu', 'Affiliation': 'Department of Urology, The Affiliated Zhangjiagang Hospital of Soochow University, Zhangjiagang, jiangsu, China.'}, {'ForeName': 'Yagang', 'Initials': 'Y', 'LastName': 'Xue', 'Affiliation': 'Department of Urology, The Affiliated Zhangjiagang Hospital of Soochow University, Zhangjiagang, jiangsu, China.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Shen', 'Affiliation': 'Department of Urology, The Affiliated Zhangjiagang Hospital of Soochow University, Zhangjiagang, jiangsu, China.'}, {'ForeName': 'Hongxing', 'Initials': 'H', 'LastName': 'Gu', 'Affiliation': 'Department of Urology, The Affiliated Zhangjiagang Hospital of Soochow University, Zhangjiagang, jiangsu, China.'}, {'ForeName': 'Haiyong', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'Department of Urology, The Affiliated Zhangjiagang Hospital of Soochow University, Zhangjiagang, jiangsu, China.'}, {'ForeName': 'Jianhua', 'Initials': 'J', 'LastName': 'Hou', 'Affiliation': 'Department of Urology, The Affiliated Zhangjiagang Hospital of Soochow University, Zhangjiagang, jiangsu, China.'}, {'ForeName': 'Huidong', 'Initials': 'H', 'LastName': 'Miao', 'Affiliation': 'Department of Urology, The Affiliated Zhangjiagang Hospital of Soochow University, Zhangjiagang, jiangsu, China.'}]",The Journal of international medical research,['10.1177/0300060519887267'] 1891,32572611,QOLEC2: a randomized controlled trial on nutritional and respiratory counseling after esophagectomy for cancer.,"BACKGROUND Esophagectomy for cancer strongly impairs quality of life. The aim of this trial was to evaluate the effect of the nutritional and respiratory counseling on postoperative quality of life. METHODS At hospital discharge, patients were randomized into four groups receiving respectively: nutritional and respiratory counseling, nutritional counseling alone, respiratory counseling alone, or standard care. The main endpoint was the impairment in quality of life in the first month after surgery. Linear mixed effect models were estimated to assess mean score differences (MDs) in quality of life scores. RESULTS Patients receiving nutritional counseling reported less appetite loss (MD - 17.7, 95% CI - 32.2 to -3.3) than those not receiving nutritional counseling at 1 month after surgery. Dyspnea was similar between patients receiving vs. those not receiving respiratory counseling (MD - 3.1, 95% CI - 10.8 to 4.6). Global quality of life was clinically similar between patients receiving vs. those not receiving nutritional counseling over time (MD 0.9, 95% CI - 5.5 to 7.3), as well as in patients receiving vs. those not receiving respiratory counseling over time (MD 0.7, 95% CI - 5.9 to 7.2). CONCLUSIONS Intensive postoperative care does not affect global quality of life even if nutritional counseling reduced appetite loss.",2020,"RESULTS Patients receiving nutritional counseling reported less appetite loss (MD - 17.7, 95% CI - 32.2 to -3.3) than those not receiving nutritional counseling at 1 month after surgery.",['after esophagectomy for cancer'],"['nutritional and respiratory counseling', 'nutritional counseling', 'QOLEC2', 'nutritional and respiratory counseling, nutritional counseling alone, respiratory counseling alone, or standard care']","['impairment in quality of life', 'Dyspnea', 'postoperative quality of life', 'mean score differences (MDs) in quality of life scores', 'appetite loss', 'Global quality of life']","[{'cui': 'C0085198', 'cui_str': 'Esophagectomy'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}]","[{'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0204932', 'cui_str': 'Diet education'}, {'cui': 'C0341618', 'cui_str': 'Counsel'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0003123', 'cui_str': 'Anorexia'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}]",,0.0621371,"RESULTS Patients receiving nutritional counseling reported less appetite loss (MD - 17.7, 95% CI - 32.2 to -3.3) than those not receiving nutritional counseling at 1 month after surgery.","[{'ForeName': 'Eleonora', 'Initials': 'E', 'LastName': 'Pinto', 'Affiliation': 'Oesophageal and Digestive Tract Surgical Unit, Veneto Institute of Oncology IOV-IRCCS, Padua, Italy.'}, {'ForeName': 'Maria Teresa', 'Initials': 'MT', 'LastName': 'Nardi', 'Affiliation': 'Nutritional Support Unit, Veneto Institute of Oncology IOV-IRCCS, Padua, Italy.'}, {'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Marchi', 'Affiliation': 'Respiratory Intensive Care Unit, Azienda Ospedaliera di Padova, Padua, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Cavallin', 'Affiliation': 'Oesophageal and Digestive Tract Surgical Unit, Veneto Institute of Oncology IOV-IRCCS, Padua, Italy.'}, {'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Alfieri', 'Affiliation': 'Oesophageal and Digestive Tract Surgical Unit, Veneto Institute of Oncology IOV-IRCCS, Padua, Italy.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Saadeh', 'Affiliation': 'Oesophageal and Digestive Tract Surgical Unit, Veneto Institute of Oncology IOV-IRCCS, Padua, Italy.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Cagol', 'Affiliation': 'Oesophageal and Digestive Tract Surgical Unit, Veneto Institute of Oncology IOV-IRCCS, Padua, Italy.'}, {'ForeName': 'Ilaria', 'Initials': 'I', 'LastName': 'Baldan', 'Affiliation': 'Nutritional Support Unit, Veneto Institute of Oncology IOV-IRCCS, Padua, Italy.'}, {'ForeName': 'Elisabetta', 'Initials': 'E', 'LastName': 'Saraceni', 'Affiliation': 'Intensive Care Unit (ISTAR 2), Azienda Ospedaliera di Padova, Padua, Italy.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Parotto', 'Affiliation': 'Intensive Care Unit, Toronto General Hospital, Toronto, Ontario, Canada.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Baratto', 'Affiliation': 'Intensive Care Unit (ISTAR 2), Azienda Ospedaliera di Padova, Padua, Italy.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Caberlotto', 'Affiliation': 'Oesophageal and Digestive Tract Surgical Unit, Veneto Institute of Oncology IOV-IRCCS, Padua, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Vianello', 'Affiliation': 'Respiratory Intensive Care Unit, Azienda Ospedaliera di Padova, Padua, Italy.'}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Castoro', 'Affiliation': 'Department. of Upper GI Surgery, Humanitas Research Hospital-Humanitas University, Rozzano, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Scarpa', 'Affiliation': 'General Surgery Unit, Azienda Ospedaliera di Padova, Padua, Italy. marcoscarpa73@yahoo.it.'}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-020-05573-z'] 1892,32568935,Apoyo con Cariño: A Qualitative Analysis of a Palliative Care-Focused Lay Patient Navigation Intervention for Hispanics With Advanced Cancer.,"A lay patient navigator model involving a culturally tailored intervention to improve palliative care outcomes for Hispanics with advanced cancer was tested across 3 urban and 5 rural cancer centers in Colorado. Five home visits were delivered over 3 months to 112 patients assigned to the randomized controlled trial's intervention arm. Grounded in core Hispanic values, visits addressed palliative care domains (advance care planning, pain/symptom management, and hospice utilization). To describe the content of patient navigator visits with patients/family caregivers, research team members analyzed 4 patient navigators' field notes comprising 499 visits to 112 patients. Based on previous work, codes were established a priori to identify ways patient navigators help patients/family caregivers. Key words and comments from field notes were classified into themes using ATLAS.ti and additional codes established. Nine common themes and exemplars describing the lay patient navigator role are described: activation/empowerment, advocacy, awareness, access, building rapport, providing support, exploring barriers, symptom screening, and the patient experience. Patient navigators used advocacy, activation, education, and motivational interviewing to address patient/family concerns and reduce barriers to quality palliative care in urban and rural settings. Adapting and implementing this model across cultures has potential to improve palliative care access to underserved populations.",2020,A lay patient navigator model involving a culturally tailored intervention to improve palliative care outcomes for Hispanics with advanced cancer was tested across 3 urban and 5 rural cancer centers in Colorado.,"['Hispanics with advanced cancer was tested across 3 urban and 5 rural cancer centers in Colorado', ""patient navigator visits with patients/family caregivers, research team members analyzed 4 patient navigators' field notes comprising 499 visits to 112 patients"", 'Hispanics With Advanced Cancer', 'urban and rural settings']","['culturally tailored intervention', 'Palliative Care-Focused Lay Patient Navigation Intervention']",[],"[{'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0009399', 'cui_str': 'Colorado'}, {'cui': 'C1709488', 'cui_str': 'Patient navigator'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086279', 'cui_str': 'Family Caregivers'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0680022', 'cui_str': 'Member of'}, {'cui': 'C0440042', 'cui_str': ""Field's stain""}, {'cui': 'C4319548', 'cui_str': '112'}]","[{'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0030231', 'cui_str': 'Palliative care'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0023668', 'cui_str': 'Liechtenstein'}, {'cui': 'C3494323', 'cui_str': 'Patient Navigation'}]",[],,0.0265818,A lay patient navigator model involving a culturally tailored intervention to improve palliative care outcomes for Hispanics with advanced cancer was tested across 3 urban and 5 rural cancer centers in Colorado.,"[{'ForeName': 'Regina M', 'Initials': 'RM', 'LastName': 'Fink', 'Affiliation': 'Regina M. Fink, PhD, APRN, CHPN, FAAN, is professor and codirector, Interprofessional Master of Science in Palliative Care Program, Division of General Internal Medicine, Department of Medicine, University of Colorado School of Medicine, Anschutz Medical Campus, Aurora. Danielle M. Kline, MS, is senior professional research assistant, Division of General Internal Medicine, Department of Medicine, University of Colorado School of Medicine, Anschutz Medical Campus, Aurora. Shaunna Siler, PhD, RN, is palliative care & aging research fellow and T-32 scholar, University of Colorado School of Medicine, Anschutz Medical Campus, Aurora. Stacy M. Fischer, MD, is associate professor, Division of General Internal Medicine, Department of Medicine, University of Colorado School of Medicine, Anschutz Medical Campus, Aurora.'}, {'ForeName': 'Danielle M', 'Initials': 'DM', 'LastName': 'Kline', 'Affiliation': ''}, {'ForeName': 'Shaunna', 'Initials': 'S', 'LastName': 'Siler', 'Affiliation': ''}, {'ForeName': 'Stacy M', 'Initials': 'SM', 'LastName': 'Fischer', 'Affiliation': ''}]",Journal of hospice and palliative nursing : JHPN : the official journal of the Hospice and Palliative Nurses Association,['10.1097/NJH.0000000000000666'] 1893,32452060,Skin seeding technique with 0.5-mm micropunch grafting for vitiligo irrespective of the epidermal-dermal orientation: Animal and clinical studies.,"Micropunch grafting is the simplest surgical intervention for refractory vitiligo but is tedious and time-consuming. Therefore, we aimed to verify the efficacy and safety of dermal orientation grafting using motorized 0.5-mm micropunch grafting for vitiligo. In a preliminary animal study, 12-week-old rats were used to observe the healing process after the transplantation of dermal orientation grafts with various punch sizes. In a clinical trial, a total of 100 vitiligo patches in 50 patients with stable vitiligo were randomly allocated to motorized 0.5-mm micropunch grafting in epidermal and dermal orientations, respectively. The grafts were implanted at intervals of 5 mm at the recipient site. Treatment success was defined as greater than 75% repigmentation. In the animal study, all grafts were shown to be well integrated into the recipient site within 3 weeks. In the clinical trial, treatment success was achieved in 72% and 76% of the epidermal and dermal orientation groups, respectively; a cobblestone appearance was observed in 4% and 2%, respectively. In conclusion, we demonstrated that this new grafting method irrespective of epidermal-dermal orientation using motorized 0.5-mm micropunch grafting was effective and safe. We have named this the ""skin seeding technique"" and it differs from traditional punch grafting in that it can be performed regardless of the graft orientation.",2020,"In the clinical trial, treatment success was achieved in 72% and 76% of the epidermal and dermal orientation groups, respectively; a cobblestone appearance was observed in 4% and 2%, respectively.","['100 vitiligo patches in 50 patients with stable vitiligo', 'vitiligo']","['Skin seeding technique with 0.5-mm micropunch grafting', 'dermal orientation grafting using motorized 0.5-mm micropunch grafting', 'Micropunch grafting', 'motorized 0.5-mm micropunch grafting']","['Treatment success', 'efficacy and safety', 'cobblestone appearance']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0042900', 'cui_str': 'Vitiligo'}, {'cui': 'C0332461', 'cui_str': 'Plaque'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205360', 'cui_str': 'Stable'}]","[{'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C1522447', 'cui_str': 'Cutaneous route'}, {'cui': 'C0029266', 'cui_str': 'Orientation'}, {'cui': 'C0449871', 'cui_str': 'Use of graft'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}]",50.0,0.0311647,"In the clinical trial, treatment success was achieved in 72% and 76% of the epidermal and dermal orientation groups, respectively; a cobblestone appearance was observed in 4% and 2%, respectively.","[{'ForeName': 'Dong Seok', 'Initials': 'DS', 'LastName': 'Kim', 'Affiliation': 'Eureka Skin & Laser Clinic, Seoul, Korea.'}, {'ForeName': 'Hyun Jeong', 'Initials': 'HJ', 'LastName': 'Ju', 'Affiliation': ""Department of Dermatology, St Vincent's Hospital, College of Medicine, The Catholic University of Korea, Suwon, Korea.""}, {'ForeName': 'Han Na', 'Initials': 'HN', 'LastName': 'Lee', 'Affiliation': ""Department of Dermatology, St Vincent's Hospital, College of Medicine, The Catholic University of Korea, Suwon, Korea.""}, {'ForeName': 'In Hye', 'Initials': 'IH', 'LastName': 'Choi', 'Affiliation': ""Department of Dermatology, Bucheon St Mary's Hospital, College of Medicine, The Catholic University of Korea, Bucheon, Korea.""}, {'ForeName': 'Sung Hye', 'Initials': 'SH', 'LastName': 'Eun', 'Affiliation': ""Department of Dermatology, St Vincent's Hospital, College of Medicine, The Catholic University of Korea, Suwon, Korea.""}, {'ForeName': 'Jiehoon', 'Initials': 'J', 'LastName': 'Kim', 'Affiliation': ""Dr Kim's Skin & Laser Clinic, Suwon, Korea.""}, {'ForeName': 'Jung Min', 'Initials': 'JM', 'LastName': 'Bae', 'Affiliation': ""Department of Dermatology, St Vincent's Hospital, College of Medicine, The Catholic University of Korea, Suwon, Korea.""}]",The Journal of dermatology,['10.1111/1346-8138.15390'] 1894,32580207,Metabolic activity in subcallosal cingulate predicts response to deep brain stimulation for depression.,"Subcallosal cingulate (SCC) deep brain stimulation (DBS) is a promising therapy for treatment-resistant depression (TRD), but response rates in open-label studies were not replicated in a large multicenter trial. Identifying biomarkers of response could improve patient selection and outcomes. We examined SCC metabolic activity as both a predictor and marker of SCC DBS treatment response. Brain glucose metabolism (CMRGlu) was measured with [18F] FDG-PET at baseline and 6 months post DBS in 20 TRD patients in a double-blind randomized controlled trial where two stimulation types (long pulse width (LPW) n = 9 and short pulse width (SPW) n = 11) were used. Responders (n = 10) were defined by a ≥48% reduction in Hamilton Depression Rating Scale scores after 6 months. The response rates were similar with five responders in each stimulation group: LPW (55.6%) and SPW (44.5%). First, differences in SCC CMRGlu in responders and non-responders were compared at baseline. Then machine learning analysis was performed with a leave-one-out cross-validation using a Gaussian naive Bayes classifier to test whether baseline CMRGlu in SCC could categorize responders. Finally, we compared 6-month change in metabolic activity with change in depression severity. All analyses were controlled for age. Baseline SCC CMRGlu was significantly higher in responders than non-responders. The machine learning analysis predicted response with 80% accuracy. Furthermore, reduction in SCC CMRGlu 6 months post DBS correlated with symptom improvement (r(17) = 0.509; p = 0.031). This is the first evidence of an image-based treatment selection biomarker that predicts SCC DBS response. Future studies could utilize SCC metabolic activity for prospective patient selection.",2020,The response rates were similar with five responders in each stimulation group: LPW (55.6%) and SPW (44.5%).,['20 TRD patients'],['Subcallosal cingulate (SCC) deep brain stimulation (DBS'],"['Brain glucose metabolism (CMRGlu', 'Baseline SCC CMRGlu', 'SCC metabolic activity', 'response rates', 'metabolic activity', 'Hamilton Depression Rating Scale scores']","[{'cui': 'C2063866', 'cui_str': 'Therapy-Resistant Depression'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0394162', 'cui_str': 'Deep brain stimulation'}]","[{'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",20.0,0.0983597,The response rates were similar with five responders in each stimulation group: LPW (55.6%) and SPW (44.5%).,"[{'ForeName': 'Elliot C', 'Initials': 'EC', 'LastName': 'Brown', 'Affiliation': 'Mathison Centre for Mental Health Research & Education, University of Calgary, Calgary, AB, Canada.'}, {'ForeName': 'Darren L', 'Initials': 'DL', 'LastName': 'Clark', 'Affiliation': 'Mathison Centre for Mental Health Research & Education, University of Calgary, Calgary, AB, Canada.'}, {'ForeName': 'Nils D', 'Initials': 'ND', 'LastName': 'Forkert', 'Affiliation': 'Hotchkiss Brain Institute, University of Calgary, Calgary, AB, Canada.'}, {'ForeName': 'Christine P', 'Initials': 'CP', 'LastName': 'Molnar', 'Affiliation': 'Department of Radiology, University of Calgary, Calgary, AB, Canada.'}, {'ForeName': 'Zelma H T', 'Initials': 'ZHT', 'LastName': 'Kiss', 'Affiliation': 'Mathison Centre for Mental Health Research & Education, University of Calgary, Calgary, AB, Canada.'}, {'ForeName': 'Rajamannar', 'Initials': 'R', 'LastName': 'Ramasubbu', 'Affiliation': 'Mathison Centre for Mental Health Research & Education, University of Calgary, Calgary, AB, Canada. rramasub@ucalgary.ca.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-020-0745-5'] 1895,32453876,"Metabolomics Reveals Altered Hepatic Bile Acids, Gut Microbiome Metabolites, and Cell Membrane Lipids Associated with Marginal Vitamin A Deficiency in a Mongolian Gerbil Model.","SCOPE This study is designed to provide a broad evaluation of the impacts of vitamin A (VA) deficiency on hepatic metabolism in a gerbil model. METHODS AND RESULTS After 28 days of VA depletion, male Mongolian gerbils (Meriones unguiculatus) are randomly assigned to experimental diets for 28 days. Groups are fed a white-maize-based diet with ≈50 µL cottonseed oil vehicle either alone (VA-, n = 10) or containing 40 µg retinyl acetate (VA+, n = 10) for 28 days. Liver retinol is measured by high-performance liquid chromatography. Primary metabolomics, aminomics, lipidomics, bile acids, oxylipins, ceramides, and endocannabinoids are analyzed in post-mortem liver samples by liquid chromatography-mass spectrometry. RESULTS Liver retinol is lower (p < 0.001) in the VA- versus VA+ group, with concentrations indicating marginal VA deficiency. A total of 300 metabolites are identified. Marginal VA deficiency is associated with lower bile acids, trimethylamine N-oxide, and a variety of acylcarnitines, phospholipids and sphingomyelins (p < 0.05). Components of DNA, including deoxyguanosine, cytidine, and N-carbomoyl-beta-alanine (p < 0.05), are differentially altered. CONCLUSIONS Hepatic metabolomics in a marginally VA-deficient gerbil model revealed alterations in markers of the gut microbiome, fatty acid and nucleotide metabolism, and cellular structure and signaling.",2020,"RESULTS Liver retinol was lower (p < 0.001) in the VA- versus VA+ group, with concentrations indicating marginal VA deficiency.",['male Mongolian gerbils (Meriones unguiculatus'],"['white maize-based diet with ∼50\xa0μL cottonseed oil vehicle either alone (VA-, n\xa0=\xa010) or containing 40\xa0μg retinyl acetate (VA+, n\xa0=\xa010) for 28 d. Liver retinol was measured by high-performance liquid chromatography (HPLC', 'vitamin A (VA) deficiency']","['Primary metabolomics, aminomics, lipidomics, bile acids, oxylipins, ceramides and endocannabinoids', 'Liver retinol', 'Hepatic Bile Acids, Gut Microbiome Metabolites, and Cell Membrane Lipids']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0324939', 'cui_str': 'Meriones unguiculatus'}, {'cui': 'C0022392', 'cui_str': 'Meriones'}]","[{'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0010028', 'cui_str': 'Zea mays'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0028908', 'cui_str': 'Oil'}, {'cui': 'C0042444', 'cui_str': 'Drug vehicle'}, {'cui': 'C0042839', 'cui_str': 'Vitamin A'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0073109', 'cui_str': 'Retinol acetate'}, {'cui': 'C0042890', 'cui_str': 'Vitamin'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0008562', 'cui_str': 'High pressure liquid chromatography'}, {'cui': 'C0011155', 'cui_str': 'Deficiency'}]","[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1328813', 'cui_str': 'Metabolomics'}, {'cui': 'C4727082', 'cui_str': 'Lipidomics'}, {'cui': 'C0005390', 'cui_str': 'Bile acid'}, {'cui': 'C1956100', 'cui_str': 'Oxylipins'}, {'cui': 'C0007745', 'cui_str': 'Ceramides'}, {'cui': 'C1172779', 'cui_str': 'Endocannabinoid'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0042839', 'cui_str': 'Vitamin A'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0025249', 'cui_str': 'Membrane lipid'}]",300.0,0.057129,"RESULTS Liver retinol was lower (p < 0.001) in the VA- versus VA+ group, with concentrations indicating marginal VA deficiency.","[{'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'La Frano', 'Affiliation': 'Department of Food Science and Nutrition, California Polytechnic State University, San Luis Obispo, CA, 93407, USA.'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Brito', 'Affiliation': 'Laboratory of Pharmacokinetics and Metabolomic Analysis, Institute of Translational Medicine and Biotechnology, I. M. Sechenov First Moscow State Medical University, Moscow, 119991, Russia.'}, {'ForeName': 'Catherine M', 'Initials': 'CM', 'LastName': 'Johnson', 'Affiliation': 'Department of Food Science and Nutrition, California Polytechnic State University, San Luis Obispo, CA, 93407, USA.'}, {'ForeName': 'Baylee', 'Initials': 'B', 'LastName': 'Wilhelmson', 'Affiliation': 'Department of Food Science and Nutrition, California Polytechnic State University, San Luis Obispo, CA, 93407, USA.'}, {'ForeName': 'Bryan', 'Initials': 'B', 'LastName': 'Gannon', 'Affiliation': 'University of Wisconsin-Madison, Department of Nutritional Sciences, Madison, WI, USA.'}, {'ForeName': 'Rob K', 'Initials': 'RK', 'LastName': 'Fanter', 'Affiliation': 'College of Agriculture, Food and Environmental Sciences, California Polytechnic State University, San Luis Obispo, CA, USA.'}, {'ForeName': 'Theresa L', 'Initials': 'TL', 'LastName': 'Pedersen', 'Affiliation': 'Department of Food Science and Technology, University of California Davis, Davis, CA, USA.'}, {'ForeName': 'Sherry A', 'Initials': 'SA', 'LastName': 'Tanumihardjo', 'Affiliation': 'University of Wisconsin-Madison, Department of Nutritional Sciences, Madison, WI, USA.'}, {'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'Newman', 'Affiliation': 'West Coast Metabolomics Center, University of California, Davis, CA, USA.'}]",Molecular nutrition & food research,['10.1002/mnfr.201901319'] 1896,32569700,The effects of combination canagliflozin and glucagon-like peptide-1 receptor agonist therapy on intermediate markers of cardiovascular risk in the CANVAS program.,"BACKGROUND Sodium glucose co-transporter 2 (SGLT2) inhibitors and glucagon-like peptide-1 receptor agonists (GLP1-RA) reduce cardiovascular events, and improve intermediate markers of cardiometabolic health, in those with type 2 diabetes. We investigated these effects in the CANVAS Program. METHODS AND RESULTS The CANVAS Program comprised 2 double-blind, randomized, placebo-controlled trials (CANVAS and CANVAS-R) done in patients with type 2 diabetes and elevated cardiovascular risk. Effects were estimated using mixed-effects models for continuous measures and Cox regression models for other outcomes. Randomized treatment by subgroup interaction terms were used to compare effects of canagliflozin versus placebo across subgroups defined by baseline use of GLP1-RA. There were 10,142 participants, of whom 407 (4%) were using GLP1-RA therapy at baseline. Those using GLP1-RA at baseline were less likely to have a history of cardiovascular disease (60.4% vs 65.8%), had a longer duration of diabetes (15.2 vs 13.5 years) and a higher body mass index (BMI; 35.6 vs 31.8 kg/m 2 ) but were otherwise similar. There were greater reductions with canagliflozin versus placebo for HbA1c (-0.75% versus -0.58%; P = .0091), SBP (-6.26 versus -3.83 mmHg; P = .0018), and body weight (-3.79 versus -2.18 kg; P < .0001) in those on baseline GLP1-RA therapy. Effects across subgroups were similar for UACR (P = .21), eGFR slope (P = .72), major adverse cardiac events (P = .94) and total serious adverse events (P = .74). CONCLUSIONS There may be a synergistic effect of SGLT2 inhibition when used on a background of GLP1-RA for intermediate cardiometabolic markers.",2020,"Effects across subgroups were similar for UACR (P = .21), eGFR slope (P = .72), major adverse cardiac events (P = .94) and total serious adverse events (P = .74). ","['10,142 participants, of whom 407 (4%) were using GLP1-RA therapy at baseline', 'patients with type 2 diabetes and elevated cardiovascular risk']","['canagliflozin versus placebo', 'placebo-controlled trials (CANVAS and CANVAS-R', 'combination canagliflozin and glucagon-like peptide-1 receptor agonist therapy', 'Sodium glucose co-transporter 2 (SGLT2) inhibitors and glucagon-like peptide-1 receptor agonists (GLP1-RA']","['body weight', 'history of cardiovascular disease', 'total serious adverse events', 'major adverse cardiac events', 'longer duration of diabetes', 'SBP', 'eGFR slope']","[{'cui': 'C1562104', 'cui_str': 'Glucagon-like peptide 1 receptor agonist-containing product'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}]","[{'cui': 'C2974540', 'cui_str': 'canagliflozin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1562104', 'cui_str': 'Glucagon-like peptide 1 receptor agonist-containing product'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0598849', 'cui_str': 'Co-Transporters'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0455539', 'cui_str': 'H/O: cardiovascular disease'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0439591', 'cui_str': 'Long duration'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0085805', 'cui_str': 'Androgen Binding Protein'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}]",10142.0,0.359796,"Effects across subgroups were similar for UACR (P = .21), eGFR slope (P = .72), major adverse cardiac events (P = .94) and total serious adverse events (P = .74). ","[{'ForeName': 'Clare', 'Initials': 'C', 'LastName': 'Arnott', 'Affiliation': 'The George Institute for Global Health, UNSW Sydney, Sydney, Australia; University of New South Wales, Sydney, Australia; Royal Prince Alfred Hospital, Camperdown, Sydney, Australia; Sydney Medical School, University of Sydney, Sydney, Australia. Electronic address: carnott@georgeinstitute.org.au.'}, {'ForeName': 'Brendon L', 'Initials': 'BL', 'LastName': 'Neuen', 'Affiliation': 'The George Institute for Global Health, UNSW Sydney, Sydney, Australia.'}, {'ForeName': 'Hiddo J L', 'Initials': 'HJL', 'LastName': 'Heerspink', 'Affiliation': 'University of New South Wales, Sydney, Australia; University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Gemma A', 'Initials': 'GA', 'LastName': 'Figtree', 'Affiliation': 'The George Institute for Global Health, UNSW Sydney, Sydney, Australia; Sydney Medical School, University of Sydney, Sydney, Australia; Kolling Institute, Royal North Shore Hospital and University of Sydney, Sydney, Australia.'}, {'ForeName': 'Mikhail', 'Initials': 'M', 'LastName': 'Kosiborod', 'Affiliation': ""Saint Luke's Mid America Heart Institute, Kansas City, MO, USA.""}, {'ForeName': 'Carolyn S', 'Initials': 'CS', 'LastName': 'Lam', 'Affiliation': 'The George Institute for Global Health, UNSW Sydney, Sydney, Australia; University of Groningen, University Medical Center Groningen, Groningen, The Netherlands; National Heart Centre Singapore and Duke-National University, Singapore.'}, {'ForeName': 'Christopher P', 'Initials': 'CP', 'LastName': 'Cannon', 'Affiliation': ""Cardiovascular Division, Brigham and Women's Hospital and Baim Institute for Clinical Research, Boston, MA, USA.""}, {'ForeName': 'Norman', 'Initials': 'N', 'LastName': 'Rosenthal', 'Affiliation': 'Janssen Research & Development, LLC, Raritan, NJ, USA.'}, {'ForeName': 'Wayne', 'Initials': 'W', 'LastName': 'Shaw', 'Affiliation': 'Janssen Research & Development, LLC, Raritan, NJ, USA.'}, {'ForeName': 'Kenneth W', 'Initials': 'KW', 'LastName': 'Mahaffey', 'Affiliation': 'Stanford Center for Clinical Research, Department of Medicine, Stanford University School of Medicine, Stanford, CA, USA.'}, {'ForeName': 'Meg J', 'Initials': 'MJ', 'LastName': 'Jardine', 'Affiliation': 'The George Institute for Global Health, UNSW Sydney, Sydney, Australia; University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Vlado', 'Initials': 'V', 'LastName': 'Perkovic', 'Affiliation': 'The George Institute for Global Health, UNSW Sydney, Sydney, Australia; University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Neal', 'Affiliation': 'The George Institute for Global Health, UNSW Sydney, Sydney, Australia; University of New South Wales, Sydney, Australia.'}]",International journal of cardiology,['10.1016/j.ijcard.2020.06.011'] 1897,32569854,Improving imagery rescripting treatments: Comparing an active versus passive approach.,"BACKGROUND AND OBJECTIVES In imagery rescripting (ImRs), aversive mental images are modified to reduce symptoms in a variety of psychological disorders. However, uniform guidelines on how to optimally implement ImRs do currently not exist. It remains unclear whether therapists should stimulate patients to imagine themselves to actively intervene within the new image, or whether they may imagine helpers to change the situation. We aimed to compare these two variants of ImRs within an analogue experimental setting. METHODS After having watched an aversive film, one-hundred participants were randomly assigned to active ImRs (ImRs-A), passive ImRs (ImRs-P), imagery rehearsal (IRE), or no-intervention control (NIC). Participants were either instructed to rescript the film by imagining themselves intervening in the new script (ImRs-A) or encouraged to imagine helpers to intervene in the imagined situation (ImRs-P). RESULTS Both ImRs increased mastery and elicited less distress than IRE with ImRs-P being experienced as less distressing than ImRs-A. Only ImRs-A led to a stronger increase in positive affect than IRE, whereas groups did not differ with respect to negative affect and self-efficacy. Conditions did not differ regarding the number of film-related intrusive memories. LIMITATIONS As a convenience sample was investigated, results cannot be generalized to clinical samples. CONCLUSION Even though differences regarding symptomatic outcome could not be detected, ImRs-P was experienced as less distressing than ImRs-A. Results suggest that both ImRs lead to different processes during the intervention than mere exposure. Compared to IRE, ImRs increases mastery with ImRs-A and ImRs-P being equally effective.",2020,"Both ImRs increased mastery and elicited less distress than IRE with ImRs-P being experienced as less distressing than ImRs-A. Only ImRs-A led to a stronger increase in positive affect than IRE, whereas groups did not differ with respect to negative affect and self-efficacy.","['After having watched an aversive film, one-hundred participants']","['active ImRs (ImRs-A), passive ImRs (ImRs-P), imagery rehearsal (IRE), or no-intervention control (NIC', 'instructed to rescript the film by imagining themselves intervening in the new script (ImRs-A) or encouraged to imagine helpers to intervene in the imagined situation (ImRs-P']",['number of film-related intrusive memories'],"[{'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C1704608', 'cui_str': 'Film'}, {'cui': 'C1704407', 'cui_str': '100'}]","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0150627', 'cui_str': 'Simple guided imagery'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1704608', 'cui_str': 'Film'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C1704608', 'cui_str': 'Film'}, {'cui': 'C0561837', 'cui_str': 'Intrusive memories'}]",100.0,0.0317839,"Both ImRs increased mastery and elicited less distress than IRE with ImRs-P being experienced as less distressing than ImRs-A. Only ImRs-A led to a stronger increase in positive affect than IRE, whereas groups did not differ with respect to negative affect and self-efficacy.","[{'ForeName': 'Marena', 'Initials': 'M', 'LastName': 'Siegesleitner', 'Affiliation': 'LMU Munich, Department of Psychology, Leopoldstraße 13, 80802, Munich, Germany.'}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Strohm', 'Affiliation': 'LMU Munich, Department of Psychology, Leopoldstraße 13, 80802, Munich, Germany.'}, {'ForeName': 'Charlotte E', 'Initials': 'CE', 'LastName': 'Wittekind', 'Affiliation': 'LMU Munich, Department of Psychology, Leopoldstraße 13, 80802, Munich, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Ehring', 'Affiliation': 'LMU Munich, Department of Psychology, Leopoldstraße 13, 80802, Munich, Germany.'}, {'ForeName': 'Anna E', 'Initials': 'AE', 'LastName': 'Kunze', 'Affiliation': 'LMU Munich, Department of Psychology, Leopoldstraße 13, 80802, Munich, Germany. Electronic address: anna.kunze@psy.lmu.de.'}]",Journal of behavior therapy and experimental psychiatry,['10.1016/j.jbtep.2020.101578'] 1898,32570152,To study the changes in maternal hemodynamics with intravenous labetalol or nifedipine in acute severe hypertension.,"OBJECTIVE To study the maternal hemodynamic changes in acute severe hypertension after treatment with intravenous labetalol or oral nifedipine using color doppler ultrasound. STUDY DESIGN We evaluated thirty pregnant women with gestational age between 28 and 40 weeks in acute severe hypertension (more than or equal to 160/105 mmHg) which were randomly allocated to receive either intravenous labetalol or oral nifedipine until blood pressure was lowered to less than or equal to 140/90 mmHg. Doppler vascular indices namely pulsatility index, resistance index, S/D ratio of bilateral uterine arteries and maternal renal artery were measured baseline at the time of acute severe hypertension and repeated after control of blood pressure, to assess the changes in maternal hemodynamics if any with labetalol or nifedipine. RESULTS When evaluating right uterine artery Doppler parameters, a trend to increase in PI and RI was observed in those who received labetalol and nifedipine however the difference was not statistically significant. Whereas, while evaluating left uterine artery indices a trend to decrease PI was seen in nifedipine group but the difference was not statistically significant. On intergroup comparison there was no any significant change in any of uterine artery as well as renal artery indices in either group. CONCLUSION The use of labetalol and nifedipine were not related to any significant changes in maternal Doppler, which is reassuring about the safety of these drugs when treating acute severe hypertension in pregnancy.",2020,"On intergroup comparison there was no any significant change in any of uterine artery as well as renal artery indices in either group. ","['thirty pregnant women with gestational age between 28 and 40\xa0weeks in acute severe hypertension (more than or equal to 160/105\xa0mmHg', 'acute severe hypertension', 'acute severe hypertension after treatment with intravenous']","['labetalol or nifedipine', 'nifedipine', 'labetalol or oral nifedipine', 'intravenous labetalol or oral nifedipine', 'labetalol and nifedipine', 'labetalol']","['renal artery indices', 'Doppler vascular indices namely pulsatility index, resistance index, S/D ratio of bilateral uterine arteries and maternal renal artery', 'PI and RI']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0439475', 'cui_str': 'mmHg'}, {'cui': 'C0001758', 'cui_str': 'Aftercare'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}]","[{'cui': 'C0022860', 'cui_str': 'Labetalol'}, {'cui': 'C0028066', 'cui_str': 'Nifedipine'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}]","[{'cui': 'C0035065', 'cui_str': 'Structure of renal artery'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0554756', 'cui_str': 'Doppler studies'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0429863', 'cui_str': 'Pulsatility index, arterial velocity waveform'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0226378', 'cui_str': 'Structure of uterine artery'}, {'cui': 'C0026591', 'cui_str': 'Mother'}]",30.0,0.0341283,"On intergroup comparison there was no any significant change in any of uterine artery as well as renal artery indices in either group. ","[{'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Thakur', 'Affiliation': 'Department of Obstetrics & Gynaecology, YSPGMC, Nahan, India. Electronic address: thakurmonika126@gmail.com.'}, {'ForeName': 'Shalini', 'Initials': 'S', 'LastName': 'Gainder', 'Affiliation': 'Department of Obstetrics & Gynaecology, PGIMER, Chandigarh, India.'}, {'ForeName': 'S C', 'Initials': 'SC', 'LastName': 'Saha', 'Affiliation': 'Department of Obstetrics & Gynaecology, PGIMER, Chandigarh, India.'}, {'ForeName': 'Mahesh', 'Initials': 'M', 'LastName': 'Prakash', 'Affiliation': 'Department of Radiodiagnosis, PGIMER, Chandigarh, India.'}]",Pregnancy hypertension,['10.1016/j.preghy.2020.05.014'] 1899,32570178,Effects of a 10-week multimodal dance and art intervention program leading to a public performance in persons with multiple sclerosis - A controlled pilot-trial.,"BACKGROUND Dance therapy is increasingly reported in neurological diseases for improving several motor and cognitive functions, but was mostly studied in partner dance. No individual choreo-based dance program has ever been reported in MS. OBJECTIVES The aim of this pilot study is to investigate effects of a ten-week choreo-based dance intervention on different impairments in MS. PARTICIPANTS Seventeen participants with MS were allocated to a dance group (DG) or an art group (AG) for a ten-week intervention program, with a public live performance at the end of the intervention. METHODS The DG received choreo-based dance courses twice a week for 90 min, while the active control AG weekly contributed to the production by painting, music, spoken word and photo- or videography. Measurements for fatigue and fatigability, physical capacity and coordination, sensory function, cognitive capacity, quality of life and dual task performance took place before and after the intervention. Differences were analysed with Wilcoxon Signed Rank test. RESULTS Both groups improved significantly on executive cognitive performance during dual task and fatigue. Only the DG improved significantly on functional lower limb strength, hand function, coordination, self-reported balance and walking, and showed a trend towards improving on cognition (PASAT). The AG showed significant improvements in on cognitive function (SDMT). CONCLUSION A ten-week multimodal dance intervention has positive effects on impact of fatigue, physical capacity and coordination, and cognitive performance during a dual task. Larger samples, follow-up measurements and research in different disability groups is recommended.",2020,"Only the DG improved significantly on functional lower limb strength, hand function, coordination, self-reported balance and walking, and showed a trend towards improving on cognition (PASAT).","['persons with multiple sclerosis', 'Seventeen participants with MS']","['active control AG weekly contributed to the production by painting, music, spoken word and photo- or videography', 'ten-week choreo-based dance intervention', 'multimodal dance and art intervention program', 'dance group (DG) or an art group (AG']","['functional lower limb strength, hand function, coordination, self-reported balance and walking, and showed a trend towards improving on cognition (PASAT', 'impact of fatigue, physical capacity and coordination, and cognitive performance', 'executive cognitive performance', 'fatigue and fatigability, physical capacity and coordination, sensory function, cognitive capacity, quality of life and dual task performance took place', 'cognitive function (SDMT']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0450331', 'cui_str': '17'}]","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0030208', 'cui_str': 'Paintings'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0010963', 'cui_str': 'Dance'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0562230', 'cui_str': 'Hand functions'}, {'cui': 'C0242414', 'cui_str': 'Coordination'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0040833', 'cui_str': 'trends'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0231230', 'cui_str': 'Fatigability'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0039333', 'cui_str': 'Task Performance'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0442504', 'cui_str': 'Place'}]",17.0,0.0172608,"Only the DG improved significantly on functional lower limb strength, hand function, coordination, self-reported balance and walking, and showed a trend towards improving on cognition (PASAT).","[{'ForeName': 'Fanny', 'Initials': 'F', 'LastName': 'Van Geel', 'Affiliation': 'REVAL Rehabilitation Research Center, Faculty of Rehabilitation Sciences, Hasselt University, Belgium. Electronic address: fanny.vangeel@uhasselt.be.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Van Asch', 'Affiliation': 'Fit Up Neurological and Sport Physiotherapy, Antwerp, Belgium; Move to Sport Foundation, Mechelsesteenweg, Kontich, Belgium.'}, {'ForeName': 'Renee', 'Initials': 'R', 'LastName': 'Veldkamp', 'Affiliation': 'REVAL Rehabilitation Research Center, Faculty of Rehabilitation Sciences, Hasselt University, Belgium. Electronic address: renee.veldkamp@uhasselt.be.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Feys', 'Affiliation': 'REVAL Rehabilitation Research Center, Faculty of Rehabilitation Sciences, Hasselt University, Belgium. Electronic address: peter.feys@uhasselt.be.'}]",Multiple sclerosis and related disorders,['10.1016/j.msard.2020.102256'] 1900,32571567,Direct Oral Anticoagulants in the Setting of Catheter Ablation of Atrial Fibrillation: State of art.,"Atrial fibrillation (AF) represents the arrhythmia of greatest clinical impact and catheter ablation of AF (CAAF) has become the most effective strategy for rhythm control in selected patients. Therefore, appropriate anticoagulation strategies are of paramount importance for patients undergoing CAAF, especially those at high risk, such those with high CHA2DS2VASc scores. Optimal management of anticoagulation before, during, and after CAAF is crucial. Several studies have evaluated the use of different anticoagulation strategies in the periprocedural period. Randomized controlled trial seem to suggest that in patients undergoing CAAF, uninterrupted (or minimally interrupted) direct oral anticoagulants (DOACs) provides an alternative to continuous vitamin K antagonists strategy, with low thromboembolic and bleeding risk.",2020,Atrial fibrillation (AF) represents the arrhythmia of greatest clinical impact and catheter ablation of AF (CAAF) has become the most effective strategy for rhythm control in selected patients.,['patients undergoing'],"['CAAF, uninterrupted (or minimally interrupted) direct oral anticoagulants (DOACs', 'catheter ablation of AF (CAAF']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0162563', 'cui_str': 'Cardiac ablation'}, {'cui': 'C0443239', 'cui_str': 'Interrupted'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0003280', 'cui_str': 'Anticoagulant'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}]",[],,0.0202978,Atrial fibrillation (AF) represents the arrhythmia of greatest clinical impact and catheter ablation of AF (CAAF) has become the most effective strategy for rhythm control in selected patients.,"[{'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Coppola', 'Affiliation': ''}, {'ForeName': 'Egle', 'Initials': 'E', 'LastName': 'Corrado', 'Affiliation': ''}, {'ForeName': 'Mirko', 'Initials': 'M', 'LastName': 'Luparelli', 'Affiliation': ''}, {'ForeName': 'Girolamo', 'Initials': 'G', 'LastName': 'Manno', 'Affiliation': ''}, {'ForeName': 'Antonino', 'Initials': 'A', 'LastName': 'Mignano', 'Affiliation': ''}, {'ForeName': 'Gianfranco', 'Initials': 'G', 'LastName': 'Ciaramitaro', 'Affiliation': ''}, {'ForeName': 'Serge', 'Initials': 'S', 'LastName': 'Boveda', 'Affiliation': ''}]",Current problems in cardiology,['10.1016/j.cpcardiol.2020.100622'] 1901,32577113,Automated Mobile Phone Messaging Utilizing a Cognitive Behavioral Intervention: A Pilot Investigation.,"Background In the setting of outpatient orthopaedic surgery, this pilot study utilized automated mobile messaging to assess (1) the feasibility of and interaction rates with a software delivered cognitive behavior therapy (CBT) intervention for postoperative opioid utilization, (2) the reliability of patient reported opioid utilization through our platform, (3) daily patient reported pain and opioid utilization within the first two postoperative weeks, and (4) the effect of software delivered CBT intervention on patient reported opioid utilization. Methods Musculoskeletal tumor patients scheduled for outpatient surgery were randomized into two study groups. Control patients received standard postoperative communication limited to a two-week postoperative follow-up visit. The intervention group received automated daily text-messages regarding pain, opioid utilization, and a daily CBT intervention. Interventional group patients also completed a patient satisfaction questionnaire at their two-week follow-up. Completion rates of all software delivered questions were determined in the interventional group. Median values of opioid utilization and interquartile range (IQR) were determined to compare utilization between groups. Spearman correlation coefficients were used to determine reliability of patient reported opioid utilization in the interventional group. Results Fourteen patients completed the pilot study (seven controls, seven intervention). Patients in the intervention arm completed 90% of pain and opioid questions. Intervention group patients utilized less of their daily prescribed opioid medication (20%, IQR:10%-27%) compared to controls (50%, IQR:4%-68%). Correlation between in-office pill counts and patient reported opioid medication utilization via our software messaging system was high (r=0.90, p=0.037). Conclusion Automated mobile phone messaging in outpatient tumor surgery yielded high interaction rates. Patient reported opioid utilization obtained through our platform demonstrated a high correlation with in-office pill counts. CBT delivered via automated mobile phone messaging demonstrated decreased opioid utilization in this pilot investigation. Level of evidence: II .",2019,"Intervention group patients utilized less of their daily prescribed opioid medication (20%, IQR:10%-27%) compared to controls (50%, IQR:4%-68%).",['Methods\n\n\nMusculoskeletal tumor patients scheduled for outpatient surgery'],"['CBT delivered via automated mobile phone messaging', 'Automated Mobile Phone Messaging Utilizing a Cognitive Behavioral Intervention', 'automated daily text-messages regarding pain, opioid utilization, and a daily CBT intervention', 'CBT intervention', 'cognitive behavior therapy (CBT) intervention']","['opioid utilization', 'pain and opioid utilization', 'Median values of opioid utilization and interquartile range (IQR', 'daily prescribed opioid medication', 'opioid medication utilization', 'patient satisfaction questionnaire']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0002428', 'cui_str': 'Ambulatory surgery'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C1136360', 'cui_str': 'Car Phone'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",,0.0693844,"Intervention group patients utilized less of their daily prescribed opioid medication (20%, IQR:10%-27%) compared to controls (50%, IQR:4%-68%).","[{'ForeName': 'Edward O', 'Initials': 'EO', 'LastName': 'Rojas', 'Affiliation': 'Department of Orthopaedics and Rehabilitation, University of Iowa Hospitals and Clinics, Iowa City, IA, USA.'}, {'ForeName': 'Chris A', 'Initials': 'CA', 'LastName': 'Anthony', 'Affiliation': 'Department of Orthopaedics and Rehabilitation, University of Iowa Hospitals and Clinics, Iowa City, IA, USA.'}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Kain', 'Affiliation': 'Department of Orthopaedics and Rehabilitation, University of Iowa Hospitals and Clinics, Iowa City, IA, USA.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Glass', 'Affiliation': 'Department of Orthopaedics and Rehabilitation, University of Iowa Hospitals and Clinics, Iowa City, IA, USA.'}, {'ForeName': 'Apurva S', 'Initials': 'AS', 'LastName': 'Shah', 'Affiliation': ""Division of Orthopaedics, Children's Hospital of Philadelphia, Philadelphia, PA, USA.""}, {'ForeName': 'Tammy', 'Initials': 'T', 'LastName': 'Smith', 'Affiliation': 'Department of Orthopaedics and Rehabilitation, University of Iowa Hospitals and Clinics, Iowa City, IA, USA.'}, {'ForeName': 'Benjamin J', 'Initials': 'BJ', 'LastName': 'Miller', 'Affiliation': 'Department of Orthopaedics and Rehabilitation, University of Iowa Hospitals and Clinics, Iowa City, IA, USA.'}]",The Iowa orthopaedic journal,[] 1902,32578755,Effectiveness of simulation in teaching immunization in nursing: a randomized clinical trial.,"OBJECTIVE to evaluate the effectiveness of the clinical simulation on the cognitive performance of nursing students in adult immunization scenarios in the context of Primary Health Care. METHOD a controlled and randomized pre-test and post-test clinical trial applied to random intervention and control groups. 34 undergraduate nursing students were selected and divided into two groups: classes with active participation of students and skills training (control); and classes with active participation of students, skills training, and clinical simulation (intervention). RESULTS the students in the intervention group performed better than those in the control group in the four assessments of cognitive performance, with statistical significance in the assessments of immediate (p=0.031) and late (1-20 days) (p=0.031) knowledge. CONCLUSION from the simulation, students learn more in the short and medium terms. The information learned is retained for longer and the students are better prepared for the professional practice. Universal Trial Number: u1111-1195-2580.",2020,"the students in the intervention group performed better than those in the control group in the four assessments of cognitive performance, with statistical significance in the assessments of immediate (p=0.031) and late (1-20 days) (p=0.031) knowledge. ","['nursing', '34 undergraduate nursing students', 'nursing students in adult immunization scenarios in the context of Primary Health Care']","['active participation of students and skills training (control); and classes with active participation of students, skills training, and clinical simulation (intervention']",[],"[{'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0038496', 'cui_str': 'Student nurse'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0020971', 'cui_str': 'Immunization'}, {'cui': 'C0449255', 'cui_str': 'Context'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}]","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0559197', 'cui_str': 'Skills training'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],,0.0408832,"the students in the intervention group performed better than those in the control group in the four assessments of cognitive performance, with statistical significance in the assessments of immediate (p=0.031) and late (1-20 days) (p=0.031) knowledge. ","[{'ForeName': 'Raphael Raniere de Oliveira', 'Initials': 'RRO', 'LastName': 'Costa', 'Affiliation': 'Universidade Federal do Rio Grande do Norte, Escola Multicampi de Ciências Médicas do Rio Grande do Norte, Caicó, RN, Brazil.'}, {'ForeName': 'Soraya Maria de', 'Initials': 'SM', 'LastName': 'Medeiros', 'Affiliation': 'Universidade Federal do Rio Grande do Norte, Departamento de Enfermagem, Natal, RN, Brazil.'}, {'ForeName': 'José Carlos Amado', 'Initials': 'JCA', 'LastName': 'Martins', 'Affiliation': 'Escola Superior de Enfermagem de Coimbra, Unidade Científico-Pedagógica de Enfermagem Médico-Cirúrgica, Coimbra, Portugal.'}, {'ForeName': 'Verónica Rita Dias', 'Initials': 'VRD', 'LastName': 'Coutinho', 'Affiliation': 'Escola Superior de Enfermagem de Coimbra, Unidade Científico-Pedagógica de Enfermagem Médico-Cirúrgica, Coimbra, Portugal.'}, {'ForeName': 'Marília Souto de', 'Initials': 'MS', 'LastName': 'Araújo', 'Affiliation': 'Universidade Federal do Rio Grande do Norte, Escola Multicampi de Ciências Médicas do Rio Grande do Norte, Caicó, RN, Brazil.'}]",Revista latino-americana de enfermagem,['10.1590/1518-8345.3147.3305'] 1903,32584168,"The Effect of ICS Withdrawal and Baseline Inhaled Treatment on Exacerbations in the IMPACT Study: A Randomized, Double-blind Multicenter Trial.","RATIONALE In the IMPACT trial fluticasone furoate/umeclidinium/ vilanterol (FF/UMEC/VI) significantly reduced exacerbations compared with FF/VI or UMEC/VI in patients with symptomatic chronic obstructive pulmonary disease and a history of exacerbations. OBJECTIVES Understand whether inhaled corticosteroid (ICS) withdrawal affected IMPACT results given direct transition from prior maintenance medication to study medication at randomization. METHODS Exacerbations and change from baseline in trough forced expiratory volume in 1 second (FEV 1 ) and St George's Respiratory Questionnaire (SGRQ) were analyzed by prior ICS use. Exacerbations were also analyzed excluding data from the first 30 days. MEASUREMENTS AND MAIN RESULTS FF/UMEC/VI significantly reduced annual moderate/severe exacerbation rate versus UMEC/VI in prior ICS users (29% reduction; p<0.001), but only a numerical reduction was seen among prior ICS non-users (12% reduction; p=0.115). To minimize impact from ICS withdrawal, in an analysis excluding the first 30 days, FF/UMEC/VI continued to significantly reduce annual on-treatment moderate/severe exacerbation rate (19%; p<0.001) versus UMEC/VI. Benefit of FF/UMEC/VI versus UMEC/VI was seen for severe exacerbation rates, regardless of prior ICS use (prior ICS users: 35% reduction, p<0.001; non-ICS users: 35% reduction, p=0.018) and overall when excluding the first 30 days (29%, p<0.001). Improvements from baseline with FF/UMEC/VI versus UMEC/VI were also maintained throughout the study for both trough FEV 1 and SGRQ regardless of prior ICS use. CONCLUSIONS These data support important treatment effects from FF/UMEC/VI combination therapy on exacerbation reduction, lung function and quality of life that do not appear to be related to abrupt ICS withdrawal. FUNDING GSK (CTT116855/NCT02164513). Clinical trial registration available at www.clinicaltrials.gov, ID: NCT02164513. This article is open access and distributed under the terms of the Creative Commons Attribution Non-Commercial No Derivatives License 4.0 (http://creativecommons.org/licenses/by-nc-nd/4.0/).",2020,"Benefit of FF/UMEC/VI versus UMEC/VI was seen for severe exacerbation rates, regardless of prior ICS use (prior ICS users: 35% reduction, p<0.001; non-ICS users: 35% reduction, p=0.018) and overall when excluding the first 30 days (29%, p<0.001).",['patients with symptomatic chronic obstructive pulmonary disease and a history of exacerbations'],"['inhaled corticosteroid (ICS', 'FF/UMEC/VI versus UMEC', 'fluticasone furoate/umeclidinium/ vilanterol (FF/UMEC/VI', 'ICS Withdrawal and Baseline Inhaled Treatment']","['severe exacerbation rates', ""trough forced expiratory volume in 1 second (FEV 1 ) and St George's Respiratory Questionnaire (SGRQ"", 'annual moderate/severe exacerbation rate', 'exacerbation reduction, lung function and quality of life', 'severe exacerbation rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0262926', 'cui_str': 'History of'}]","[{'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C2935023', 'cui_str': 'vilanterol'}, {'cui': 'C1948374', 'cui_str': 'fluticasone furoate'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0444506', 'cui_str': 'Trough'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",,0.74081,"Benefit of FF/UMEC/VI versus UMEC/VI was seen for severe exacerbation rates, regardless of prior ICS use (prior ICS users: 35% reduction, p<0.001; non-ICS users: 35% reduction, p=0.018) and overall when excluding the first 30 days (29%, p<0.001).","[{'ForeName': 'MeiLan K', 'Initials': 'MK', 'LastName': 'Han', 'Affiliation': 'University of Michigan, 1259, Pulmonary & Critical Care, Ann Arbor, Michigan, United States; mrking@umich.edu.'}, {'ForeName': 'Gerard J', 'Initials': 'GJ', 'LastName': 'Criner', 'Affiliation': 'Temple University Hospital, 25139, Pulmonary & Critical Care Medicine, Philadelphia, Pennsylvania, United States.'}, {'ForeName': 'Mark T', 'Initials': 'MT', 'LastName': 'Dransfield', 'Affiliation': 'University of Alabama at Birmingham, 9968, Division of Pulmonary, Allergy, and Critical Care Medicine, Lung Health Center, Birmingham, Alabama, United States.'}, {'ForeName': 'David M G', 'Initials': 'DMG', 'LastName': 'Halpin', 'Affiliation': 'University of Exeter Medical School, 171002, College of Medicine and Health, Exeter, Devon, United Kingdom of Great Britain and Northern Ireland.'}, {'ForeName': 'C Elaine', 'Initials': 'CE', 'LastName': 'Jones', 'Affiliation': 'GlaxoSmithKline Plc, 1929, Development, R&D, Collegeville, Pennsylvania, United States.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Kilbride', 'Affiliation': 'GlaxoSmithKline Plc, 1929, Biostatistics, Stockley Park West, Uxbridge, United Kingdom of Great Britain and Northern Ireland.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Lange', 'Affiliation': 'University of Copenhagen, 4321, Department of Public Health, Kobenhavn, Denmark.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Lettis', 'Affiliation': 'GlaxoSmithKline Plc, 1929, Biostatistics, Stockley Park West, Uxbridge, United Kingdom of Great Britain and Northern Ireland.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Lipson', 'Affiliation': 'GlaxoSmithKline Plc, 1929, Clinical Sciences, Collegeville, Pennsylvania, United States.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Lomas', 'Affiliation': 'University College London, 4919, UCL Respiratory, London, United Kingdom of Great Britain and Northern Ireland.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Martin', 'Affiliation': 'GlaxoSmithKline Plc, 1929, Global Medical Affairs, Brentford, United Kingdom of Great Britain and Northern Ireland.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Wise', 'Affiliation': 'Johns Hopkins University School of Medicine, 1500, Division of Pulmonary and Critical Care Medicine, Baltimore, Maryland, United States.'}, {'ForeName': 'Dave', 'Initials': 'D', 'LastName': 'Singh', 'Affiliation': 'Manchester Academic Health Science Centre, 158986, Centre for Respiratory Medicine and Allergy, Institute of Inflammation and Repair, Manchester, United Kingdom of Great Britain and Northern Ireland.'}, {'ForeName': 'Fernando J', 'Initials': 'FJ', 'LastName': 'Martinez', 'Affiliation': 'NewYork-Presbyterian Hospital/Weill Cornell Medical Center, 159947, New York, New York, United States.'}]",American journal of respiratory and critical care medicine,['10.1164/rccm.201912-2478OC'] 1904,32579807,Triple Inhaled Therapy at Two Glucocorticoid Doses in Moderate-to-Very-Severe COPD.,"BACKGROUND Triple fixed-dose regimens of an inhaled glucocorticoid, a long-acting muscarinic antagonist (LAMA), and a long-acting β 2 -agonist (LABA) for chronic obstructive pulmonary disease (COPD) have been studied at single dose levels of inhaled glucocorticoid, but studies at two dose levels are lacking. METHODS In a 52-week, phase 3, randomized trial to evaluate the efficacy and safety of triple therapy at two dose levels of inhaled glucocorticoid in patients with moderate-to-very-severe COPD and at least one exacerbation in the past year, we assigned patients in a 1:1:1:1 ratio to receive twice-daily inhaled doses of triple therapy (inhaled glucocorticoid [320 μg or 160 μg of budesonide], a LAMA [18 μg of glycopyrrolate], and a LABA [9.6 μg of formoterol]) or one of two dual therapies (18 μg of glycopyrrolate plus 9.6 μg of formoterol or 320 μg of budesonide plus 9.6 μg of formoterol). The primary end point was the annual rate (the estimated mean number per patient per year) of moderate or severe COPD exacerbations, as analyzed in the modified intention-to-treat population with the use of on-treatment data only. RESULTS The modified intention-to-treat population comprised 8509 patients. The annual rates of moderate or severe exacerbations were 1.08 in the 320-μg-budesonide triple-therapy group (2137 patients), 1.07 in the 160-μg-budesonide triple-therapy group (2121 patients), 1.42 in the glycopyrrolate-formoterol group (2120 patients), and 1.24 in the budesonide-formoterol group (2131 patients). The rate was significantly lower with 320-μg-budesonide triple therapy than with glycopyrrolate-formoterol (24% lower: rate ratio, 0.76; 95% confidence interval [CI], 0.69 to 0.83; P<0.001) or budesonide-formoterol (13% lower: rate ratio, 0.87; 95% CI, 0.79 to 0.95; P = 0.003). Similarly, the rate was significantly lower with 160-μg-budesonide triple therapy than with glycopyrrolate-formoterol (25% lower: rate ratio, 0.75; 95% CI, 0.69 to 0.83; P<0.001) or budesonide-formoterol (14% lower: rate ratio, 0.86; 95% CI, 0.79 to 0.95; P = 0.002). The incidence of any adverse event was similar across the treatment groups (range, 61.7 to 64.5%); the incidence of confirmed pneumonia ranged from 3.5 to 4.5% in the groups that included inhaled glucocorticoid use and was 2.3% in the glycopyrrolate-formoterol group. CONCLUSIONS Triple therapy with twice-daily budesonide (at either the 160-μg or 320-μg dose), glycopyrrolate, and formoterol resulted in a lower rate of moderate or severe COPD exacerbations than glycopyrrolate-formoterol or budesonide-formoterol. (Funded by AstraZeneca, ETHOS ClinicalTrials.gov number, NCT02465567.).",2020,"The incidence of any adverse event was similar across the treatment groups (range, 61.7 to 64.5%); the incidence of confirmed pneumonia ranged from 3.5 to 4.5% in the groups that included inhaled glucocorticoid use and was 2.3% in the glycopyrrolate-formoterol group. ","['patients with moderate-to-very-severe COPD and at least one exacerbation in the past year', 'Moderate-to-Very-Severe COPD', 'chronic obstructive pulmonary disease (COPD', '8509 patients']","['LAMA', 'glycopyrrolate-formoterol', 'inhaled glucocorticoid', 'triple therapy (inhaled glucocorticoid [320 μg or 160 μg of budesonide', 'glycopyrrolate-formoterol or budesonide-formoterol', 'LABA [9.6 μg of formoterol', 'inhaled glucocorticoid, a long-acting muscarinic antagonist (LAMA', 'glycopyrrolate, and formoterol', 'glycopyrrolate', 'budesonide-formoterol', 'glycopyrrolate plus 9.6 μg of formoterol or 320 μg of budesonide plus 9.6 μg of formoterol']","['moderate or severe COPD exacerbations', 'incidence of confirmed pneumonia', 'annual rates of moderate or severe exacerbations', 'incidence of any adverse event', 'efficacy and safety', 'annual rate', 'rate of moderate or severe COPD exacerbations']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C3641272', 'cui_str': 'Very severe'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0003385', 'cui_str': 'Muscarinic receptor antagonist'}, {'cui': 'C0017970', 'cui_str': 'Glycopyrrolate'}, {'cui': 'C0060657', 'cui_str': 'formoterol'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0017710', 'cui_str': 'Glucocorticoid'}, {'cui': 'C0205174', 'cui_str': 'Triple'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C4517711', 'cui_str': '320'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0054201', 'cui_str': 'Budesonide'}, {'cui': 'C1276807', 'cui_str': 'formoterol and budesonide'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0740304', 'cui_str': 'COPD exacerbation'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.540992,"The incidence of any adverse event was similar across the treatment groups (range, 61.7 to 64.5%); the incidence of confirmed pneumonia ranged from 3.5 to 4.5% in the groups that included inhaled glucocorticoid use and was 2.3% in the glycopyrrolate-formoterol group. ","[{'ForeName': 'Klaus F', 'Initials': 'KF', 'LastName': 'Rabe', 'Affiliation': 'From LungenClinic Grosshansdorf and Christian-Albrechts University Kiel, Airway Research Center North, German Center for Lung Research (DZL), Grosshansdorf, Germany (K.F.R.); the Joan and Sanford I. Weill Department of Medicine, Weill Cornell Medicine, New York (F.J.M.); the Pulmonary Research Institute of Southeast Michigan, Farmington Hills (G.T.F.); the National Clinical Research Center for Respiratory Diseases, China-Japan Friendship Hospital, Beijing (C.W.); the Medicines Evaluation Unit, University of Manchester, Manchester University NHS Foundation Hospitals Trust, Manchester (D.S.), and the National Heart and Lung Institute, Imperial College London, London (J.A.W.) - both in the United Kingdom; AstraZeneca, Durham, NC (R.T., P. Dorinsky); AstraZeneca, Morristown, NJ (E.S.R., S.B., P. Darken, C.R.); AstraZeneca, Gaithersburg, MD (J.M.); and AstraZeneca, Gothenburg, Sweden (M.A.).'}, {'ForeName': 'Fernando J', 'Initials': 'FJ', 'LastName': 'Martinez', 'Affiliation': 'From LungenClinic Grosshansdorf and Christian-Albrechts University Kiel, Airway Research Center North, German Center for Lung Research (DZL), Grosshansdorf, Germany (K.F.R.); the Joan and Sanford I. Weill Department of Medicine, Weill Cornell Medicine, New York (F.J.M.); the Pulmonary Research Institute of Southeast Michigan, Farmington Hills (G.T.F.); the National Clinical Research Center for Respiratory Diseases, China-Japan Friendship Hospital, Beijing (C.W.); the Medicines Evaluation Unit, University of Manchester, Manchester University NHS Foundation Hospitals Trust, Manchester (D.S.), and the National Heart and Lung Institute, Imperial College London, London (J.A.W.) - both in the United Kingdom; AstraZeneca, Durham, NC (R.T., P. Dorinsky); AstraZeneca, Morristown, NJ (E.S.R., S.B., P. Darken, C.R.); AstraZeneca, Gaithersburg, MD (J.M.); and AstraZeneca, Gothenburg, Sweden (M.A.).'}, {'ForeName': 'Gary T', 'Initials': 'GT', 'LastName': 'Ferguson', 'Affiliation': 'From LungenClinic Grosshansdorf and Christian-Albrechts University Kiel, Airway Research Center North, German Center for Lung Research (DZL), Grosshansdorf, Germany (K.F.R.); the Joan and Sanford I. Weill Department of Medicine, Weill Cornell Medicine, New York (F.J.M.); the Pulmonary Research Institute of Southeast Michigan, Farmington Hills (G.T.F.); the National Clinical Research Center for Respiratory Diseases, China-Japan Friendship Hospital, Beijing (C.W.); the Medicines Evaluation Unit, University of Manchester, Manchester University NHS Foundation Hospitals Trust, Manchester (D.S.), and the National Heart and Lung Institute, Imperial College London, London (J.A.W.) - both in the United Kingdom; AstraZeneca, Durham, NC (R.T., P. Dorinsky); AstraZeneca, Morristown, NJ (E.S.R., S.B., P. Darken, C.R.); AstraZeneca, Gaithersburg, MD (J.M.); and AstraZeneca, Gothenburg, Sweden (M.A.).'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'From LungenClinic Grosshansdorf and Christian-Albrechts University Kiel, Airway Research Center North, German Center for Lung Research (DZL), Grosshansdorf, Germany (K.F.R.); the Joan and Sanford I. Weill Department of Medicine, Weill Cornell Medicine, New York (F.J.M.); the Pulmonary Research Institute of Southeast Michigan, Farmington Hills (G.T.F.); the National Clinical Research Center for Respiratory Diseases, China-Japan Friendship Hospital, Beijing (C.W.); the Medicines Evaluation Unit, University of Manchester, Manchester University NHS Foundation Hospitals Trust, Manchester (D.S.), and the National Heart and Lung Institute, Imperial College London, London (J.A.W.) - both in the United Kingdom; AstraZeneca, Durham, NC (R.T., P. Dorinsky); AstraZeneca, Morristown, NJ (E.S.R., S.B., P. Darken, C.R.); AstraZeneca, Gaithersburg, MD (J.M.); and AstraZeneca, Gothenburg, Sweden (M.A.).'}, {'ForeName': 'Dave', 'Initials': 'D', 'LastName': 'Singh', 'Affiliation': 'From LungenClinic Grosshansdorf and Christian-Albrechts University Kiel, Airway Research Center North, German Center for Lung Research (DZL), Grosshansdorf, Germany (K.F.R.); the Joan and Sanford I. Weill Department of Medicine, Weill Cornell Medicine, New York (F.J.M.); the Pulmonary Research Institute of Southeast Michigan, Farmington Hills (G.T.F.); the National Clinical Research Center for Respiratory Diseases, China-Japan Friendship Hospital, Beijing (C.W.); the Medicines Evaluation Unit, University of Manchester, Manchester University NHS Foundation Hospitals Trust, Manchester (D.S.), and the National Heart and Lung Institute, Imperial College London, London (J.A.W.) - both in the United Kingdom; AstraZeneca, Durham, NC (R.T., P. Dorinsky); AstraZeneca, Morristown, NJ (E.S.R., S.B., P. Darken, C.R.); AstraZeneca, Gaithersburg, MD (J.M.); and AstraZeneca, Gothenburg, Sweden (M.A.).'}, {'ForeName': 'Jadwiga A', 'Initials': 'JA', 'LastName': 'Wedzicha', 'Affiliation': 'From LungenClinic Grosshansdorf and Christian-Albrechts University Kiel, Airway Research Center North, German Center for Lung Research (DZL), Grosshansdorf, Germany (K.F.R.); the Joan and Sanford I. Weill Department of Medicine, Weill Cornell Medicine, New York (F.J.M.); the Pulmonary Research Institute of Southeast Michigan, Farmington Hills (G.T.F.); the National Clinical Research Center for Respiratory Diseases, China-Japan Friendship Hospital, Beijing (C.W.); the Medicines Evaluation Unit, University of Manchester, Manchester University NHS Foundation Hospitals Trust, Manchester (D.S.), and the National Heart and Lung Institute, Imperial College London, London (J.A.W.) - both in the United Kingdom; AstraZeneca, Durham, NC (R.T., P. Dorinsky); AstraZeneca, Morristown, NJ (E.S.R., S.B., P. Darken, C.R.); AstraZeneca, Gaithersburg, MD (J.M.); and AstraZeneca, Gothenburg, Sweden (M.A.).'}, {'ForeName': 'Roopa', 'Initials': 'R', 'LastName': 'Trivedi', 'Affiliation': 'From LungenClinic Grosshansdorf and Christian-Albrechts University Kiel, Airway Research Center North, German Center for Lung Research (DZL), Grosshansdorf, Germany (K.F.R.); the Joan and Sanford I. Weill Department of Medicine, Weill Cornell Medicine, New York (F.J.M.); the Pulmonary Research Institute of Southeast Michigan, Farmington Hills (G.T.F.); the National Clinical Research Center for Respiratory Diseases, China-Japan Friendship Hospital, Beijing (C.W.); the Medicines Evaluation Unit, University of Manchester, Manchester University NHS Foundation Hospitals Trust, Manchester (D.S.), and the National Heart and Lung Institute, Imperial College London, London (J.A.W.) - both in the United Kingdom; AstraZeneca, Durham, NC (R.T., P. Dorinsky); AstraZeneca, Morristown, NJ (E.S.R., S.B., P. Darken, C.R.); AstraZeneca, Gaithersburg, MD (J.M.); and AstraZeneca, Gothenburg, Sweden (M.A.).'}, {'ForeName': 'Earl', 'Initials': 'E', 'LastName': 'St Rose', 'Affiliation': 'From LungenClinic Grosshansdorf and Christian-Albrechts University Kiel, Airway Research Center North, German Center for Lung Research (DZL), Grosshansdorf, Germany (K.F.R.); the Joan and Sanford I. Weill Department of Medicine, Weill Cornell Medicine, New York (F.J.M.); the Pulmonary Research Institute of Southeast Michigan, Farmington Hills (G.T.F.); the National Clinical Research Center for Respiratory Diseases, China-Japan Friendship Hospital, Beijing (C.W.); the Medicines Evaluation Unit, University of Manchester, Manchester University NHS Foundation Hospitals Trust, Manchester (D.S.), and the National Heart and Lung Institute, Imperial College London, London (J.A.W.) - both in the United Kingdom; AstraZeneca, Durham, NC (R.T., P. Dorinsky); AstraZeneca, Morristown, NJ (E.S.R., S.B., P. Darken, C.R.); AstraZeneca, Gaithersburg, MD (J.M.); and AstraZeneca, Gothenburg, Sweden (M.A.).'}, {'ForeName': 'Shaila', 'Initials': 'S', 'LastName': 'Ballal', 'Affiliation': 'From LungenClinic Grosshansdorf and Christian-Albrechts University Kiel, Airway Research Center North, German Center for Lung Research (DZL), Grosshansdorf, Germany (K.F.R.); the Joan and Sanford I. Weill Department of Medicine, Weill Cornell Medicine, New York (F.J.M.); the Pulmonary Research Institute of Southeast Michigan, Farmington Hills (G.T.F.); the National Clinical Research Center for Respiratory Diseases, China-Japan Friendship Hospital, Beijing (C.W.); the Medicines Evaluation Unit, University of Manchester, Manchester University NHS Foundation Hospitals Trust, Manchester (D.S.), and the National Heart and Lung Institute, Imperial College London, London (J.A.W.) - both in the United Kingdom; AstraZeneca, Durham, NC (R.T., P. Dorinsky); AstraZeneca, Morristown, NJ (E.S.R., S.B., P. Darken, C.R.); AstraZeneca, Gaithersburg, MD (J.M.); and AstraZeneca, Gothenburg, Sweden (M.A.).'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'McLaren', 'Affiliation': 'From LungenClinic Grosshansdorf and Christian-Albrechts University Kiel, Airway Research Center North, German Center for Lung Research (DZL), Grosshansdorf, Germany (K.F.R.); the Joan and Sanford I. Weill Department of Medicine, Weill Cornell Medicine, New York (F.J.M.); the Pulmonary Research Institute of Southeast Michigan, Farmington Hills (G.T.F.); the National Clinical Research Center for Respiratory Diseases, China-Japan Friendship Hospital, Beijing (C.W.); the Medicines Evaluation Unit, University of Manchester, Manchester University NHS Foundation Hospitals Trust, Manchester (D.S.), and the National Heart and Lung Institute, Imperial College London, London (J.A.W.) - both in the United Kingdom; AstraZeneca, Durham, NC (R.T., P. Dorinsky); AstraZeneca, Morristown, NJ (E.S.R., S.B., P. Darken, C.R.); AstraZeneca, Gaithersburg, MD (J.M.); and AstraZeneca, Gothenburg, Sweden (M.A.).'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Darken', 'Affiliation': 'From LungenClinic Grosshansdorf and Christian-Albrechts University Kiel, Airway Research Center North, German Center for Lung Research (DZL), Grosshansdorf, Germany (K.F.R.); the Joan and Sanford I. Weill Department of Medicine, Weill Cornell Medicine, New York (F.J.M.); the Pulmonary Research Institute of Southeast Michigan, Farmington Hills (G.T.F.); the National Clinical Research Center for Respiratory Diseases, China-Japan Friendship Hospital, Beijing (C.W.); the Medicines Evaluation Unit, University of Manchester, Manchester University NHS Foundation Hospitals Trust, Manchester (D.S.), and the National Heart and Lung Institute, Imperial College London, London (J.A.W.) - both in the United Kingdom; AstraZeneca, Durham, NC (R.T., P. Dorinsky); AstraZeneca, Morristown, NJ (E.S.R., S.B., P. Darken, C.R.); AstraZeneca, Gaithersburg, MD (J.M.); and AstraZeneca, Gothenburg, Sweden (M.A.).'}, {'ForeName': 'Magnus', 'Initials': 'M', 'LastName': 'Aurivillius', 'Affiliation': 'From LungenClinic Grosshansdorf and Christian-Albrechts University Kiel, Airway Research Center North, German Center for Lung Research (DZL), Grosshansdorf, Germany (K.F.R.); the Joan and Sanford I. Weill Department of Medicine, Weill Cornell Medicine, New York (F.J.M.); the Pulmonary Research Institute of Southeast Michigan, Farmington Hills (G.T.F.); the National Clinical Research Center for Respiratory Diseases, China-Japan Friendship Hospital, Beijing (C.W.); the Medicines Evaluation Unit, University of Manchester, Manchester University NHS Foundation Hospitals Trust, Manchester (D.S.), and the National Heart and Lung Institute, Imperial College London, London (J.A.W.) - both in the United Kingdom; AstraZeneca, Durham, NC (R.T., P. Dorinsky); AstraZeneca, Morristown, NJ (E.S.R., S.B., P. Darken, C.R.); AstraZeneca, Gaithersburg, MD (J.M.); and AstraZeneca, Gothenburg, Sweden (M.A.).'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'Reisner', 'Affiliation': 'From LungenClinic Grosshansdorf and Christian-Albrechts University Kiel, Airway Research Center North, German Center for Lung Research (DZL), Grosshansdorf, Germany (K.F.R.); the Joan and Sanford I. Weill Department of Medicine, Weill Cornell Medicine, New York (F.J.M.); the Pulmonary Research Institute of Southeast Michigan, Farmington Hills (G.T.F.); the National Clinical Research Center for Respiratory Diseases, China-Japan Friendship Hospital, Beijing (C.W.); the Medicines Evaluation Unit, University of Manchester, Manchester University NHS Foundation Hospitals Trust, Manchester (D.S.), and the National Heart and Lung Institute, Imperial College London, London (J.A.W.) - both in the United Kingdom; AstraZeneca, Durham, NC (R.T., P. Dorinsky); AstraZeneca, Morristown, NJ (E.S.R., S.B., P. Darken, C.R.); AstraZeneca, Gaithersburg, MD (J.M.); and AstraZeneca, Gothenburg, Sweden (M.A.).'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Dorinsky', 'Affiliation': 'From LungenClinic Grosshansdorf and Christian-Albrechts University Kiel, Airway Research Center North, German Center for Lung Research (DZL), Grosshansdorf, Germany (K.F.R.); the Joan and Sanford I. Weill Department of Medicine, Weill Cornell Medicine, New York (F.J.M.); the Pulmonary Research Institute of Southeast Michigan, Farmington Hills (G.T.F.); the National Clinical Research Center for Respiratory Diseases, China-Japan Friendship Hospital, Beijing (C.W.); the Medicines Evaluation Unit, University of Manchester, Manchester University NHS Foundation Hospitals Trust, Manchester (D.S.), and the National Heart and Lung Institute, Imperial College London, London (J.A.W.) - both in the United Kingdom; AstraZeneca, Durham, NC (R.T., P. Dorinsky); AstraZeneca, Morristown, NJ (E.S.R., S.B., P. Darken, C.R.); AstraZeneca, Gaithersburg, MD (J.M.); and AstraZeneca, Gothenburg, Sweden (M.A.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa1916046'] 1905,32571718,Safety and immunogenicity of three seasonal inactivated influenza vaccines among pregnant women and antibody persistence in their infants.,"OBJECTIVE Inactivated influenza virus vaccines (IIVs) are recommended for all pregnant women in the United States. We conducted a prospective, randomized, double blind study of three licensed seasonal trivalent IIVs (IIV3s) to assess their safety and immunogenicity in pregnant women and determine the level and persistence of passively transferred maternal antibody in infants. STUDY DESIGN 139 pregnant women ages 18-39 years and 14-33 weeks' gestation, and 44 non-pregnant women, were randomized 1:1:1 to receive a single intramuscular dose of one of three licensed IIV3s (Agriflu®, Fluzone®, or Fluarix®) prior to the 2010-2011 influenza season. Reactogenicity, adverse events (AEs) and pregnancy outcomes were documented. Serum samples for hemagglutination inhibition (HAI) and neutralization antibody assays were collected prior to and 28 and 180 days after immunization. Maternal sera and cord blood were collected at the time of delivery and sera were obtained from 44 infants at 6 weeks of age. RESULTS Pregnant and non-pregnant women experienced similar frequency of injection site (92% and 86%, respectively) and systemic (95% and 87%, respectively) reactions, the majority of which were mild. There were no vaccine-associated maternal or infant serious AEs. Antibody responses to the three vaccine antigens were not different between pregnant and non-pregnant women. The ratios of cord blood (infant) to maternal HAI antibody titers at delivery ranged between 1.1 and 1.7 for each of the vaccine antigens. Influenza antibody concentrations in infants were 70-40% of the birth titer by 6 weeks of age. CONCLUSIONS The three IIV3s were well tolerated in pregnant women. Antibody responses were comparable in pregnant and non-pregnant women, and after second or third trimester vaccination. Transplacental transfer of maternal antibodies to the infant was efficient. However, antibody titers decline rapidly in the first 6 weeks of life.",2020,Antibody responses to the three vaccine antigens were not different between pregnant and non-pregnant women.,"['infants were 70-40% of the birth titer by 6\xa0weeks of age', 'pregnant women and determine the level and persistence of passively transferred maternal antibody in infants', 'all pregnant women in the United States', ""139 pregnant women ages 18-39\xa0years and 14-33\xa0weeks' gestation, and 44 non-pregnant women"", 'pregnant women and antibody persistence in their infants', 'pregnant women']","['licensed IIV3s (Agriflu®, Fluzone®, or Fluarix®', 'licensed seasonal trivalent IIVs (IIV3s', 'influenza virus vaccines (IIVs', 'seasonal inactivated influenza vaccines']","['Influenza antibody concentrations', 'Safety and immunogenicity', 'Antibody responses', 'Serum samples for hemagglutination inhibition (HAI) and neutralization antibody assays', 'Reactogenicity, adverse events (AEs) and pregnancy outcomes', 'safety and immunogenicity', 'Maternal sera and cord blood', 'Transplacental transfer of maternal antibodies', 'frequency of injection site', 'ratios of cord blood (infant) to maternal HAI antibody titers']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0475208', 'cui_str': 'Titer'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0546816', 'cui_str': 'Persistence'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0729663', 'cui_str': 'Maternal antibody'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C5191072', 'cui_str': '139'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}]","[{'cui': 'C0023636', 'cui_str': 'Licenses'}, {'cui': 'C0591524', 'cui_str': 'fluarix'}, {'cui': 'C0439601', 'cui_str': 'Seasonal course'}, {'cui': 'C0021403', 'cui_str': 'Influenza virus vaccine'}]","[{'cui': 'C0236493', 'cui_str': 'Influenza antibody'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0003261', 'cui_str': 'Antibody Production'}, {'cui': 'C1550100', 'cui_str': 'Serum specimen'}, {'cui': 'C0018904', 'cui_str': 'Hemagglutination inhibition assay'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C0005507', 'cui_str': 'Bioassay'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0032972', 'cui_str': 'Outcomes, Pregnancy'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0162371', 'cui_str': 'Cord blood'}, {'cui': 'C0442375', 'cui_str': 'Transplacental approach'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0729663', 'cui_str': 'Maternal antibody'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0221208', 'cui_str': 'Injection site'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0474643', 'cui_str': 'Antibody titer measurement'}]",139.0,0.0806985,Antibody responses to the three vaccine antigens were not different between pregnant and non-pregnant women.,"[{'ForeName': 'Flor M', 'Initials': 'FM', 'LastName': 'Munoz', 'Affiliation': 'Department of Pediatrics, Houston, TX, United States; Department of Molecular Virology and Microbiology, Houston, TX, United States. Electronic address: florm@bcm.edu.'}, {'ForeName': 'Shital M', 'Initials': 'SM', 'LastName': 'Patel', 'Affiliation': 'Department of Molecular Virology and Microbiology, Houston, TX, United States; Department of Medicine, Baylor College of Medicine, Houston, TX, United States.'}, {'ForeName': 'Lisa A', 'Initials': 'LA', 'LastName': 'Jackson', 'Affiliation': 'Kaiser Permanente Washington Health Research Institute, Seattle, WA, United States.'}, {'ForeName': 'Geeta K', 'Initials': 'GK', 'LastName': 'Swamy', 'Affiliation': 'Department of Obstetrics & Gynecology, Duke University, Durham, NC, United States.'}, {'ForeName': 'Kathryn M', 'Initials': 'KM', 'LastName': 'Edwards', 'Affiliation': 'Vanderbilt Vaccine Research Program, Department of Pediatrics, Vanderbilt University, Nashville, TN, United States.'}, {'ForeName': 'Sharon E', 'Initials': 'SE', 'LastName': 'Frey', 'Affiliation': 'Saint Louis University School of Medicine, St. Louis, MO, United States.'}, {'ForeName': 'Carey R', 'Initials': 'CR', 'LastName': 'Petrie', 'Affiliation': 'The EMMES Company, LLC, Rockville, MD, United States.'}, {'ForeName': 'Eli A', 'Initials': 'EA', 'LastName': 'Sendra', 'Affiliation': 'The EMMES Company, LLC, Rockville, MD, United States.'}, {'ForeName': 'Wendy A', 'Initials': 'WA', 'LastName': 'Keitel', 'Affiliation': 'Department of Molecular Virology and Microbiology, Houston, TX, United States; Department of Medicine, Baylor College of Medicine, Houston, TX, United States.'}]",Vaccine,['10.1016/j.vaccine.2020.05.059'] 1906,32571773,"Oseltamivir for coronavirus illness: post-hoc exploratory analysis of an open-label, pragmatic, randomised controlled trial in European primary care from 2016 to 2018.","BACKGROUND Patients infected with the novel coronavirus (SARS-CoV-2) are being treated empirically with oseltamivir, but there is little evidence from randomised controlled trials to support the treatment of coronavirus infections with oseltamivir. AIM To determine whether adding oseltamivir to usual care reduces time to recovery in symptomatic patients who have tested positive for coronavirus (not including SARS-CoV-2). DESIGN AND SETTING Exploratory analysis of data from an open-label, pragmatic, randomised controlled trial during three influenza seasons, from 2016 to 2018, in primary care research networks, in 15 European countries. METHOD Patients aged ≥1 year presenting to primary care with influenza-like illness (ILI), and who tested positive for coronavirus (not including SARS-CoV-2), were randomised to usual care or usual care plus oseltamivir. The primary outcome was time to recovery defined as a return to usual activities, with minor or absent fever, headache, and muscle ache. RESULTS Coronaviruses (CoV-229E, CoV-OC43, CoV-KU1 and CoV-NL63) were identified in 308 (9%) out of 3266 randomised participants in the trial; 153 of these were allocated to usual care and 155 to usual care plus oseltamivir; the primary outcome was ascertained in 136 and 147 participants, respectively. The median time to recovery was shorter in patients randomised to oseltamivir: 4 days (interquartile range [IQR] 3-6) versus 5 days (IQR 3-8; hazard ratio 1.31; 95% confidence interval = 1.03 to 1.66; P = 0.026). CONCLUSION Primary care patients with ILI testing positive for coronavirus (not including SARS-CoV-2) recovered sooner when oseltamivir was added to usual care compared with usual care alone. This may be of relevance to the primary care management of COVID-19.",2020,"CONCLUSION Primary care patients with ILI testing positive for coronavirus (not including SARS-CoV-2) recovered sooner when oseltamivir was added to usual care compared with usual care alone.","['Patients aged ≥1 year presenting to primary care with influenza-like illness (ILI), and who tested positive for coronavirus (not including SARS-CoV-2', 'Primary care patients with ILI testing positive for coronavirus (not including SARS-CoV-2', 'coronavirus illness', 'Patients infected with the novel coronavirus (SARS-CoV-2', 'European primary care from 2016 to 2018', 'Exploratory analysis of data from an open-label, pragmatic, randomised controlled trial during three influenza seasons, from 2016 to 2018, in primary care research networks, in 15 European countries', 'symptomatic patients who have tested positive for coronavirus (not including SARS-CoV-2']","['usual care plus oseltamivir', 'oseltamivir', 'Oseltamivir', 'usual care or usual care plus oseltamivir']","['time to recovery defined as a return to usual activities, with minor or absent fever, headache, and muscle ache', 'median time to recovery']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0392171', 'cui_str': 'Influenza-like symptoms'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0021400', 'cui_str': 'Influenza'}, {'cui': 'C0036497', 'cui_str': 'Seasons'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0454713', 'cui_str': 'European country'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}]","[{'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0874161', 'cui_str': 'Oseltamivir'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0026193', 'cui_str': 'Minor'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0231528', 'cui_str': 'Muscle pain'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",3266.0,0.207108,"CONCLUSION Primary care patients with ILI testing positive for coronavirus (not including SARS-CoV-2) recovered sooner when oseltamivir was added to usual care compared with usual care alone.","[{'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Coenen', 'Affiliation': 'Centre for General Practice, Department of Family Medicine & Health Policy (FAMPOP); Laboratory of Medical Microbiology, Vaccine & Infectious Disease Institute (VAXINFECTIO), University of Antwerp, Antwerp, Belgium.'}, {'ForeName': 'Alike W', 'Initials': 'AW', 'LastName': 'van der Velden', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Cianci', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands.'}, {'ForeName': 'Herman', 'Initials': 'H', 'LastName': 'Goossens', 'Affiliation': 'Laboratory of Medical Microbiology, Vaccine and Infectious Disease Institute (VAXINFECTIO), University of Antwerp, Antwerp; Laboratory of Clinical Microbiology, Antwerp University Hospital, Edegem, Belgium.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Bongard', 'Affiliation': 'Department of Primary Care Health Sciences, University of Oxford, Radcliffe Observatory Quarter, Oxford, UK.'}, {'ForeName': 'Benjamin R', 'Initials': 'BR', 'LastName': 'Saville', 'Affiliation': 'Berry Consultants, Austin, Texas, US; adjunct assistant professor, Vanderbilt University, Department of Biostatistics, Nashville, Tennessee, US.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Gobat', 'Affiliation': 'Department of Primary Care Health Sciences, University of Oxford, Radcliffe Observatory Quarter, Oxford, UK.'}, {'ForeName': 'Muireann', 'Initials': 'M', 'LastName': 'de Paor', 'Affiliation': 'Department of General Practice, Royal College of Surgeons in Ireland School of Medicine, Dublin, Ireland.'}, {'ForeName': 'Margareta', 'Initials': 'M', 'LastName': 'Ieven', 'Affiliation': 'Laboratory of Medical Microbiology, Vaccine and Infectious Disease Institute (VAXINFECTIO), University of Antwerp, Antwerp; Laboratory of Clinical Microbiology, Antwerp University Hospital, Edegem, Belgium.'}, {'ForeName': 'Theo J', 'Initials': 'TJ', 'LastName': 'Verheij', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands.'}, {'ForeName': 'Christopher C', 'Initials': 'CC', 'LastName': 'Butler', 'Affiliation': 'Department of Primary Care Health Sciences, University of Oxford, Radcliffe Observatory Quarter, Oxford, UK.'}]",The British journal of general practice : the journal of the Royal College of General Practitioners,['10.3399/bjgp20X711941'] 1907,32578478,Inclusion of resistance routines in a hypoxia training program does not interfere with prevention of acute mountain sickness.,"OBJECTIVES Acclimatization strategies have been shown to be the best solutions to avoid acute mountain sickness. In this context, we have designed a protocol performed in hypoxia that includes resistance routines in combination with classical endurance training exercises with mountain trekking at mid altitude. METHODS Thirty-two volunteers preparing different mountain expeditions participated in the study distributed into two groups. One group trained at 2000 m, while another group trained at 4500-5800 m of simulated altitude in a hypoxic chamber. Acute mountain sickness was monitored by answering the Lake Louise Scale questionnaire during 2 sleeping sessions at 4800 m of simulated altitude at the beginning and at the end of the study. At the same time, oxygen saturation was determined in both groups to monitor physiologic adaptation. Data were also collected from the base camps in each expedition before ascension. RESULTS Acute mountain sickness incidence in the hypoxic group decreased from 100% at the beginning to 12% of individuals at the end of the training period, and it was 25% at the base camps of expeditions. On the other hand, the control group passed from 100% to 88% of individuals at the end of the intervention and 70% at the base camps. At the same time, acute mountain sickness severity was mild in the experimental group compared to moderate-severe in the control group. These data were supported by the oxygen saturation values, indicating adequate adaptation changes for altitude in the hypoxic group. CONCLUSION The inclusion of resistance workouts in combination with endurance exercises, all performed in hypoxic conditions, does not interfere with an optimal adaptation to altitude and to prevent acute mountain sickness.",2020,"At the same time, acute mountain sickness severity was mild in the experimental group compared to moderate-severe in the control group.","['with mountain trekking at mid altitude', 'Thirty-two volunteers preparing different mountain expeditions participated in the study, distributed into 2 groups']","['classical endurance training exercises', 'Hypoxia Training Program']","['Acute mountain sickness', 'Lake Louise Scale questionnaire', 'acute mountain sickness severity', 'oxygen saturation', 'Acute mountain sickness incidence']","[{'cui': 'C0442533', 'cui_str': 'Mountain'}, {'cui': 'C0444598', 'cui_str': 'Mid'}, {'cui': 'C0002349', 'cui_str': 'Altitude'}, {'cui': 'C0450357', 'cui_str': '32'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0015315', 'cui_str': 'Expeditions'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C4704697', 'cui_str': 'Endurance Training'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0238284', 'cui_str': 'Acute mountain sickness'}, {'cui': 'C0337049', 'cui_str': 'Lake'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",32.0,0.0122975,"At the same time, acute mountain sickness severity was mild in the experimental group compared to moderate-severe in the control group.","[{'ForeName': 'Aritz', 'Initials': 'A', 'LastName': 'Urdampilleta', 'Affiliation': 'ElikaEsport®. Nutrition, Innovation and Sport , Barcelona, Spain.'}, {'ForeName': 'Patxi', 'Initials': 'P', 'LastName': 'León-Guereño', 'Affiliation': 'Department of Psychology, University of Deusto , Bilbao, Spain.'}, {'ForeName': 'Julio', 'Initials': 'J', 'LastName': 'Calleja-González', 'Affiliation': 'Department of Physical Education and Sports, University of Basque Country (UPV-EHU) , Vitoria, Spain.'}, {'ForeName': 'Enrique', 'Initials': 'E', 'LastName': 'Roche', 'Affiliation': 'Department of Applied Biology-Nutrition, Institute of Bioengineering, University Miguel Hernandez (Elche). Alicante Institute for Health and Biomedical Research (ISABIAL) , Alicante, Spain.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Mielgo-Ayuso', 'Affiliation': 'Department of Biochemistry, Molecular Biology and Physiology, Faculty of Physical Therapy, University of Valladolid , Soria, Spain.'}]",The Physician and sportsmedicine,['10.1080/00913847.2020.1786344'] 1908,32579195,Effect of Colchicine vs Standard Care on Cardiac and Inflammatory Biomarkers and Clinical Outcomes in Patients Hospitalized With Coronavirus Disease 2019: The GRECCO-19 Randomized Clinical Trial.,"Importance Severe acute respiratory syndrome coronavirus 2 infection has evolved into a global pandemic. Low-dose colchicine combines anti-inflammatory action with a favorable safety profile. Objective To evaluate the effect of treatment with colchicine on cardiac and inflammatory biomarkers and clinical outcomes in patients hospitalized with coronavirus disease 2019 (COVID-19). Design, Setting, and Participants In this prospective, open-label, randomized clinical trial (the Greek Study in the Effects of Colchicine in COVID-19 Complications Prevention), 105 patients hospitalized with COVID-19 were randomized in a 1:1 allocation from April 3 to April 27, 2020, to either standard medical treatment or colchicine with standard medical treatment. The study took place in 16 tertiary hospitals in Greece. Intervention Colchicine administration (1.5-mg loading dose followed by 0.5 mg after 60 min and maintenance doses of 0.5 mg twice daily) with standard medical treatment for as long as 3 weeks. Main Outcomes and Measures Primary end points were (1) maximum high-sensitivity cardiac troponin level; (2) time for C-reactive protein to reach more than 3 times the upper reference limit; and (3) time to deterioration by 2 points on a 7-grade clinical status scale, ranging from able to resume normal activities to death. Secondary end points were (1) the percentage of participants requiring mechanical ventilation, (2) all-cause mortality, and (3) number, type, severity, and seriousness of adverse events. The primary efficacy analysis was performed on an intention-to-treat basis. Results A total of 105 patients were evaluated (61 [58.1%] men; median [interquartile range] age, 64 [54-76] years) with 50 (47.6%) randomized to the control group and 55 (52.4%) to the colchicine group. Median (interquartile range) peak high-sensitivity cardiac troponin values were 0.0112 (0.0043-0.0093) ng/mL in the control group and 0.008 (0.004-0.0135) ng/mL in the colchicine group (P = .34). Median (interquartile range) maximum C-reactive protein levels were 4.5 (1.4-8.9) mg/dL vs 3.1 (0.8-9.8) mg/dL (P = .73), respectively. The clinical primary end point rate was 14.0% in the control group (7 of 50 patients) and 1.8% in the colchicine group (1 of 55 patients) (odds ratio, 0.11; 95% CI, 0.01-0.96; P = .02). Mean (SD) event-free survival time was 18.6 (0.83) days the in the control group vs 20.7 (0.31) in the colchicine group (log rank P = .03). Adverse events were similar in the 2 groups, except for diarrhea, which was more frequent with colchicine group than the control group (25 patients [45.5%] vs 9 patients [18.0%]; P = .003). Conclusions and Relevance In this randomized clinical trial, participants who received colchicine had statistically significantly improved time to clinical deterioration. There were no significant differences in high-sensitivity cardiac troponin or C-reactive protein levels. These findings should be interpreted with caution. Trial Registration ClinicalTrials.gov Identifier: NCT04326790.",2020,"Adverse events were similar in the 2 groups, except for diarrhea, which was more frequent with colchicine group than the control group (25 patients [45.5%] vs 9 patients [18.0%]; P = .003). ","['A total of 105 patients were evaluated (61 [58.1%] men; median [interquartile range] age, 64 [54-76] years) with 50 (47.6%) randomized to the control group and 55 (52.4%) to the', 'patients hospitalized with coronavirus disease 2019 (COVID-19', '105 patients hospitalized with COVID-19', 'Patients Hospitalized With Coronavirus Disease 2019', '16 tertiary hospitals in Greece']","['Colchicine', 'standard medical treatment or colchicine with standard medical treatment', 'Colchicine vs Standard Care', 'colchicine']","['time to clinical deterioration', 'diarrhea', 'Adverse events', 'high-sensitivity cardiac troponin or C-reactive protein levels', 'Mean (SD) event-free survival time', 'Median (interquartile range) maximum C-reactive protein levels', 'Median (interquartile range) peak high-sensitivity cardiac troponin values', 'maximum high-sensitivity cardiac troponin level; (2) time for C-reactive protein to reach more than 3 times the upper reference limit; and (3) time to deterioration by 2 points on a 7-grade clinical status scale, ranging from able to resume normal activities to death', 'intention-to-treat basis', 'percentage of participants requiring mechanical ventilation, (2) all-cause mortality, and (3) number, type, severity, and seriousness of adverse events']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0018226', 'cui_str': 'Greece'}]","[{'cui': 'C0009262', 'cui_str': 'Colchicine'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C4505323', 'cui_str': 'Clinical Deterioration'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C1096316', 'cui_str': 'Cardiac troponin'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0163299', 'cui_str': 'A 7'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0449440', 'cui_str': 'Clinical status'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0205404', 'cui_str': 'Serious'}]",105.0,0.277987,"Adverse events were similar in the 2 groups, except for diarrhea, which was more frequent with colchicine group than the control group (25 patients [45.5%] vs 9 patients [18.0%]; P = .003). ","[{'ForeName': 'Spyridon G', 'Initials': 'SG', 'LastName': 'Deftereos', 'Affiliation': 'Second Department of Cardiology, Attikon Hospital, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Georgios', 'Initials': 'G', 'LastName': 'Giannopoulos', 'Affiliation': 'Department of Cardiology, G. Gennimatas General Hospital of Athens, Athens, Greece.'}, {'ForeName': 'Dimitrios A', 'Initials': 'DA', 'LastName': 'Vrachatis', 'Affiliation': 'Cardio Center, Humanitas Clinical and Research Hospital IRCCS, Rozzano-Milan, Italy.'}, {'ForeName': 'Gerasimos D', 'Initials': 'GD', 'LastName': 'Siasos', 'Affiliation': 'First Department of Cardiology, Hippokration Hospital, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Sotiria G', 'Initials': 'SG', 'LastName': 'Giotaki', 'Affiliation': 'Second Department of Cardiology, Attikon Hospital, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Panagiotis', 'Initials': 'P', 'LastName': 'Gargalianos', 'Affiliation': 'Athens Medical Center, Athens, Greece.'}, {'ForeName': 'Simeon', 'Initials': 'S', 'LastName': 'Metallidis', 'Affiliation': 'First Department of Internal Medicine, AHEPA Hospital, Aristotle University of Thessaloniki, Thessaloniki, Greece.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Sianos', 'Affiliation': 'First Department of Cardiology, AHEPA Hospital, Aristotle University of Thessaloniki, Thessaloniki, Greece.'}, {'ForeName': 'Stefanos', 'Initials': 'S', 'LastName': 'Baltagiannis', 'Affiliation': 'Department of Internal Medicine, General Hospital of Kastoria, Kastoria, Greece.'}, {'ForeName': 'Periklis', 'Initials': 'P', 'LastName': 'Panagopoulos', 'Affiliation': 'Second Department of Internal Medicine, General Hospital of Alexandroupoli, Democritus University of Thrace, Alexandroupoli, Greece.'}, {'ForeName': 'Konstantinos', 'Initials': 'K', 'LastName': 'Dolianitis', 'Affiliation': 'Department of Internal Medicine, Mpodosakio General Hospital of Ptolemaida, Ptolemaida, Greece.'}, {'ForeName': 'Efthalia', 'Initials': 'E', 'LastName': 'Randou', 'Affiliation': 'Department of Internal Medicine, General Hospital of Kozani, Kozani, Greece.'}, {'ForeName': 'Konstantinos', 'Initials': 'K', 'LastName': 'Syrigos', 'Affiliation': 'Third Department of Internal Medicine, General Hospital Sotiria, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Anastasia', 'Initials': 'A', 'LastName': 'Kotanidou', 'Affiliation': 'First Intensive Care Unit, General Hospital Evangelismos, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Nikolaos G', 'Initials': 'NG', 'LastName': 'Koulouris', 'Affiliation': 'First Department of Pneumonology, General Hospital Sotiria, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Haralampos', 'Initials': 'H', 'LastName': 'Milionis', 'Affiliation': 'First Department of Internal Medicine, Ioannina University Hospital, University of Ioannina, Ioannina, Greece.'}, {'ForeName': 'Nikolaos', 'Initials': 'N', 'LastName': 'Sipsas', 'Affiliation': 'Infectious Diseases Unit, Laiko General Hospital, Athens, Greece.'}, {'ForeName': 'Charalampos', 'Initials': 'C', 'LastName': 'Gogos', 'Affiliation': 'Internal Medicine Department, University Hospital of Patras, Patras, Greece.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Tsoukalas', 'Affiliation': 'Fourth Department of Pneumonology, General Hospital Sotiria, Athens, Greece.'}, {'ForeName': 'Christoforos D', 'Initials': 'CD', 'LastName': 'Olympios', 'Affiliation': 'Department of Cardiology, General Hospital of Elefsina Thriasio, Elefsina, Greece.'}, {'ForeName': 'Eleftheria', 'Initials': 'E', 'LastName': 'Tsagalou', 'Affiliation': 'Therapeutics Department, Alexandra Hospital, Athens, Greece.'}, {'ForeName': 'Ilias', 'Initials': 'I', 'LastName': 'Migdalis', 'Affiliation': 'Second Medical Department, NIMTS Hospital, Athens, Greece.'}, {'ForeName': 'Styliani', 'Initials': 'S', 'LastName': 'Gerakari', 'Affiliation': 'Department of Internal Medicine, General Hospital of West Attica Agia Varvara, Athens, Greece.'}, {'ForeName': 'Christos', 'Initials': 'C', 'LastName': 'Angelidis', 'Affiliation': 'Second Department of Cardiology, Attikon Hospital, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Dimitrios', 'Initials': 'D', 'LastName': 'Alexopoulos', 'Affiliation': 'Second Department of Cardiology, Attikon Hospital, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Pericles', 'Initials': 'P', 'LastName': 'Davlouros', 'Affiliation': 'Department of Cardiology, University of Patras Medical School, Patras, Greece.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Hahalis', 'Affiliation': 'Department of Cardiology, University of Patras Medical School, Patras, Greece.'}, {'ForeName': 'Ioannis', 'Initials': 'I', 'LastName': 'Kanonidis', 'Affiliation': 'Second Department of Cardiology, AHEPA Hospital, Aristotle University of Thessaloniki, Thessaloniki, Greece.'}, {'ForeName': 'Demosthenes', 'Initials': 'D', 'LastName': 'Katritsis', 'Affiliation': 'Third Department of Cardiology, Hygeia Hospital, Athens, Greece.'}, {'ForeName': 'Theofilos', 'Initials': 'T', 'LastName': 'Kolettis', 'Affiliation': 'Department of Cardiology, Ioannina University Hospital, University of Ioannina, Ioannina, Greece.'}, {'ForeName': 'Antonios S', 'Initials': 'AS', 'LastName': 'Manolis', 'Affiliation': 'First Department of Cardiology, Hippokration Hospital, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Lampros', 'Initials': 'L', 'LastName': 'Michalis', 'Affiliation': 'Department of Cardiology, Ioannina University Hospital, University of Ioannina, Ioannina, Greece.'}, {'ForeName': 'Katerina K', 'Initials': 'KK', 'LastName': 'Naka', 'Affiliation': 'Department of Cardiology, Ioannina University Hospital, University of Ioannina, Ioannina, Greece.'}, {'ForeName': 'Vlasios N', 'Initials': 'VN', 'LastName': 'Pyrgakis', 'Affiliation': 'Department of Cardiology, G. Gennimatas General Hospital of Athens, Athens, Greece.'}, {'ForeName': 'Konstantinos P', 'Initials': 'KP', 'LastName': 'Toutouzas', 'Affiliation': 'First Department of Cardiology, Hippokration Hospital, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Filippos', 'Initials': 'F', 'LastName': 'Triposkiadis', 'Affiliation': 'Department of Cardiology, University General Hospital of Larissa, Larissa, Greece.'}, {'ForeName': 'Konstantinos', 'Initials': 'K', 'LastName': 'Tsioufis', 'Affiliation': 'First Department of Cardiology, Hippokration Hospital, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Emmanouil', 'Initials': 'E', 'LastName': 'Vavouranakis', 'Affiliation': 'Third Department of Cardiology, General Hospital Sotiria, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Martinèz-Dolz', 'Affiliation': 'Hospital Universitario y Politécnico La Fe, Valencia, Spain.'}, {'ForeName': 'Bernhard', 'Initials': 'B', 'LastName': 'Reimers', 'Affiliation': 'Cardio Center, Humanitas Clinical and Research Hospital IRCCS, Rozzano-Milan, Italy.'}, {'ForeName': 'Giulio G', 'Initials': 'GG', 'LastName': 'Stefanini', 'Affiliation': 'Cardio Center, Humanitas Clinical and Research Hospital IRCCS, Rozzano-Milan, Italy.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Cleman', 'Affiliation': 'Section of Cardiovascular Medicine, Yale University School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Goudevenos', 'Affiliation': 'Department of Cardiology, Ioannina University Hospital, University of Ioannina, Ioannina, Greece.'}, {'ForeName': 'Sotirios', 'Initials': 'S', 'LastName': 'Tsiodras', 'Affiliation': 'Fourth Department of Internal Medicine, Attikon Hospital, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Dimitrios', 'Initials': 'D', 'LastName': 'Tousoulis', 'Affiliation': 'First Department of Cardiology, Hippokration Hospital, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Efstathios', 'Initials': 'E', 'LastName': 'Iliodromitis', 'Affiliation': 'Second Department of Cardiology, Attikon Hospital, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Roxana', 'Initials': 'R', 'LastName': 'Mehran', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Dangas', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, New York.'}, {'ForeName': 'Christodoulos', 'Initials': 'C', 'LastName': 'Stefanadis', 'Affiliation': 'First Department of Cardiology, Hippokration Hospital, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",JAMA network open,['10.1001/jamanetworkopen.2020.13136'] 1909,32574895,Randomized controlled study comparing tonsillectomy safety and patient satisfaction outcomes between HARMONIC ACE® + shears and monopolar diathermy in an adult population - A pilot study.,"PURPOSE Various types of the harmonic scalpel blades have been used for tonsillectomy since the early 2000s with varying successes. The HARMONIC ACE® + 23 cm shears is a relatively new blade which has not been studied in an adult population yet. METHODOLOGY A randomized controlled pilot study was performed comparing the HARMONIC ACE® + 23 cm shears (HS) and monopolar electrocautery (EC) tonsillectomy in 20 patients. Intraoperative blood loss, pain control, return to normal diet and activity as well as patient satisfaction outcomes were compared between these two arms. RESULTS The operative time was comparable. Compared to the EC arm, there was less intraoperative bleeding, lower risks of delayed haemorrhage and readmission in the HS arm. Post-operative pain scores and use of analgesia were similar. There was earlier return to normal diet and activity in the HS arm compared to the EC arm. More patients in the HS arm recommended using HARMONIC ACE® + 23 cm shears compared to those in the EC arm. This is a non-inferiority study which suggests that the HARMONIC ACE® + 23 cm shears is comparable to monopolar electrocautery in terms of efficacy and post-operative complication rates with better patient satisfaction outcomes. The main weakness of the study is a small study population. CONCLUSION This is the first reported study comparing the use of the HARMONIC ACE® + 23 cm shears with monopolar cautery in tonsillectomy. A prospective adequately powered study validated by objective outcome measures would be useful to verify the findings from this pilot study.",2020,"Compared to the EC arm, there was less intraoperative bleeding, lower risks of delayed haemorrhage and readmission in the HS arm.",['20 patients'],"['ACE®\xa0+\xa0shears and monopolar diathermy', 'harmonic scalpel blades', 'ACE®\xa0+\xa023\xa0cm shears (HS) and monopolar electrocautery (EC) tonsillectomy', 'ACE®\xa0+\xa023\xa0cm shears with monopolar cautery in tonsillectomy']","['Post-operative pain scores and use of analgesia', 'intraoperative bleeding, lower risks of delayed haemorrhage and readmission', 'operative time', 'Intraoperative blood loss, pain control, return to normal diet and activity as well as patient satisfaction outcomes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0050385', 'cui_str': 'AC protocol'}, {'cui': 'C0175735', 'cui_str': 'Scissors'}, {'cui': 'C0012002', 'cui_str': 'Diathermy'}, {'cui': 'C0392220', 'cui_str': 'Scalpel'}, {'cui': 'C2948008', 'cui_str': 'Blade'}, {'cui': 'C0013804', 'cui_str': 'Electrocoagulation'}, {'cui': 'C0040423', 'cui_str': 'Tonsillectomy'}, {'cui': 'C0007471', 'cui_str': 'Cauterization - action'}]","[{'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0184625', 'cui_str': 'Normal diet'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.0502624,"Compared to the EC arm, there was less intraoperative bleeding, lower risks of delayed haemorrhage and readmission in the HS arm.","[{'ForeName': 'Wei Ming James', 'Initials': 'WMJ', 'LastName': 'Kwek', 'Affiliation': 'Department of Otolaryngology - Head and Neck Surgery, Changi General Hospital, Singapore.'}, {'ForeName': 'Shu May Celeste Ann', 'Initials': 'SMCA', 'LastName': 'Chua', 'Affiliation': 'Department of Otolaryngology - Head and Neck Surgery, Changi General Hospital, Singapore.'}, {'ForeName': 'Shu Hui', 'Initials': 'SH', 'LastName': 'Xu', 'Affiliation': 'Department of Otolaryngology - Head and Neck Surgery, Changi General Hospital, Singapore.'}, {'ForeName': 'Toh Hui Leonard', 'Initials': 'THL', 'LastName': 'Tan', 'Affiliation': 'Department of Otolaryngology - Head and Neck Surgery, Changi General Hospital, Singapore.'}, {'ForeName': 'Xin Yong', 'Initials': 'XY', 'LastName': 'Huang', 'Affiliation': 'Department of Otolaryngology - Head and Neck Surgery, Changi General Hospital, Singapore.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Loh', 'Affiliation': 'Department of Otolaryngology - Head and Neck Surgery, Changi General Hospital, Singapore.'}, {'ForeName': 'Tee Sin', 'Initials': 'TS', 'LastName': 'Lee', 'Affiliation': 'Department of Otolaryngology - Head and Neck Surgery, Changi General Hospital, Singapore. Electronic address: lee.tee.sin@singhealth.com.sg.'}]",American journal of otolaryngology,['10.1016/j.amjoto.2020.102568'] 1910,32583982,The Effects of Vitamin D and Marine Omega-3 Fatty Acid Supplementation on Chronic Knee Pain in Older U.S. Adults: Results from a Randomized Trial.,"OBJECTIVE Knee pain from osteoarthritis is frequent in the adult population. Prior trials have had conflicting results concerning vitamin D's therapeutic effects on knee pain and few trials have investigated marine omega-3 fatty acids (n-3 FA). METHODS The double-blind, placebo-controlled VITamin D and OmegA-3 TriaL (VITAL) randomized 25,871 U.S. adults in a two-by-two factorial design to vitamin D and n-3 FA. We identified a subgroup with chronic knee pain prior to randomization and assessed knee pain at baseline and annually during follow-up with the Western Ontario and McMaster Universities Arthritis Index (WOMAC; 0-100, 100 worst). Repeated measures modeling tested the effect of randomized treatment on WOMAC Pain over follow-up after adjustment for age and sex. Analyses were repeated for WOMAC Function and Stiffness. RESULTS We included 1,398 participants who returned at least one knee pain questionnaire. Mean age was 67.7 years, 66% were female, and mean WOMAC Pain was 37 (SD 19). Mean follow-up time was 5.3 years (SD 0.7). WOMAC Pain did not differ between vitamin D or n-3 FA and placebo at any time point during follow-up. Linear time by treatment interactions were not statistically significant for either treatment (vitamin D p= 0.41, n-3 FA p= 0.77). Vitamin D and n-3 FA supplementation did not significantly affect WOMAC Function or Stiffness scores over time. CONCLUSION Vitamin D and n-3 FA supplementation for a mean of 5.3 years did not reduce knee pain or improve function or stiffness in a large sample of U.S adults with chronic knee pain.",2020,WOMAC Pain did not differ between vitamin D or n-3 FA and placebo at any time point during follow-up.,"['1,398 participants who returned at least one knee pain questionnaire', 'subgroup with chronic knee pain prior to randomization and assessed knee pain at baseline and annually during follow-up with the Western Ontario and McMaster Universities Arthritis Index', 'adults with chronic knee pain', 'Older U.S. Adults', 'Mean age was 67.7 years, 66% were female, and mean WOMAC Pain was 37 (SD 19']","['vitamin D and n-3 FA', 'Vitamin D and n-3 FA supplementation', 'placebo-controlled VITamin D and OmegA-3 TriaL', 'vitamin D or n-3 FA and placebo', 'Vitamin D and Marine Omega-3 Fatty Acid Supplementation']","['knee pain', 'Chronic Knee Pain', 'WOMAC Function or Stiffness scores', 'WOMAC Function and Stiffness', 'WOMAC Pain']","[{'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0231749', 'cui_str': 'Knee pain'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0003864', 'cui_str': 'Arthritis'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]","[{'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0524645', 'cui_str': 'Marines'}, {'cui': 'C0561929', 'cui_str': 'N-3 fatty acid supplementation'}]","[{'cui': 'C0231749', 'cui_str': 'Knee pain'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",25871.0,0.401195,WOMAC Pain did not differ between vitamin D or n-3 FA and placebo at any time point during follow-up.,"[{'ForeName': 'Lindsey A', 'Initials': 'LA', 'LastName': 'MacFarlane', 'Affiliation': ""Orthopedic and Arthritis Center for Outcomes Research, Department of Orthopedic Surgery, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Nancy R', 'Initials': 'NR', 'LastName': 'Cook', 'Affiliation': ""Division of Preventive Medicine, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Eunjung', 'Initials': 'E', 'LastName': 'Kim', 'Affiliation': ""Division of Preventive Medicine, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'I-Min', 'Initials': 'IM', 'LastName': 'Lee', 'Affiliation': ""Division of Preventive Medicine, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Maura D', 'Initials': 'MD', 'LastName': 'Iversen', 'Affiliation': ""Division of Rheumatology, Inflammation and Immunity, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Gordon', 'Affiliation': ""Division of Preventive Medicine, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Julie E', 'Initials': 'JE', 'LastName': 'Buring', 'Affiliation': ""Division of Preventive Medicine, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Jeffrey N', 'Initials': 'JN', 'LastName': 'Katz', 'Affiliation': ""Orthopedic and Arthritis Center for Outcomes Research, Department of Orthopedic Surgery, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'JoAnn E', 'Initials': 'JE', 'LastName': 'Manson', 'Affiliation': ""Division of Preventive Medicine, Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Karen H', 'Initials': 'KH', 'LastName': 'Costenbader', 'Affiliation': ""Division of Rheumatology, Inflammation and Immunity, Brigham and Women's Hospital, Boston, MA, USA.""}]","Arthritis & rheumatology (Hoboken, N.J.)",['10.1002/art.41416'] 1911,32584276,A Comparative Assessment of the Management of Mandibular Angle Fractures Using 3D Plates and 2D Miniplates.,"AIMS The aim of this study was to compare 2D plates with 3D miniplate system in the management of mandibular angle fractures. MATERIALS AND METHODS The study was conducted on 146 patients with mandibular angle fracture, who were equally divided into two groups of 73. Patients in group I were treated with 3D plating and in group II with 2D plating. In all cases, 2.0 mm titanium miniplates were used. The etiology of fracture, amount of mouth opening, and pain and sensory deficit were recorded. Clinical and radiographic assessment was done at 1, 3, and 6 months. RESULTS The etiology of mandibular angle fracture is roadside accident (RSA) seen in 110 (75.3%) cases, fall in 24 (16.4%), and assault in 12 (2.6%) cases. There was significant ( p < 0.05) mouth opening in group I at 1 month postoperatively (32.4 mm) as compared to group II (27.5 mm), at 3 months in group I (33.6 mm) as compared to group II (30.2 mm), and at 6 months in group I (36.4 mm) as compared to group II (31.6 mm). After 1 month, sensory deficit was present in six patients in group I and 10 patients in group II. After 3 months, group I had no patients and three patients in group II. Right angle fracture was found in 71 patients (group I-36, group II-35). Mandibular right angle fracture in 58 patients (group I-28, group II-30). CONCLUSION The authors found that the 3D miniplate system is more useful in the management of cases of mandibular angle fracture as compared to 2D miniplates. CLINICAL SIGNIFICANCE There has been increase in mandibular fractures in the last few years. Appropriate management with 3D miniplates may be useful in providing better treatment outcomes.",2020,"There was significant ( p < 0.05) mouth opening in group I at 1 month postoperatively (32.4 mm) as compared to group II (27.5 mm), at 3 months in group I (33.6 mm) as compared to group II (30.2 mm), and at 6 months in group I (36.4 mm) as compared to group II (31.6 mm).","['58 patients (group I-28, group II-30', '146 patients with mandibular angle fracture, who were equally divided into two groups of 73']",[],"['sensory deficit', 'Right angle fracture', 'mandibular fractures', 'etiology of fracture, amount of mouth opening, and pain and sensory deficit', 'Mandibular right angle fracture']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441843', 'cui_str': 'Group I'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0332849', 'cui_str': 'Divide'}]",[],"[{'cui': 'C0748618', 'cui_str': 'Sensory deficit'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0024692', 'cui_str': 'Fracture of mandible'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0240379', 'cui_str': 'Open mouth'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}]",146.0,0.0204353,"There was significant ( p < 0.05) mouth opening in group I at 1 month postoperatively (32.4 mm) as compared to group II (27.5 mm), at 3 months in group I (33.6 mm) as compared to group II (30.2 mm), and at 6 months in group I (36.4 mm) as compared to group II (31.6 mm).","[{'ForeName': 'Revati', 'Initials': 'R', 'LastName': 'Singh', 'Affiliation': 'Department of Dentistry, Patna Dental College and Hospital, Patna, Bihar, India, Phone: +91 8210356292, e-mail: revateesingh@gmail.com.'}, {'ForeName': 'Rohit', 'Initials': 'R', 'LastName': 'Singh', 'Affiliation': 'Department of Prosthodontics, Crown, Bridge and Implantology, Patna Dental College and Hospital, Patna, Bihar, India.'}, {'ForeName': 'Cheranjeevi', 'Initials': 'C', 'LastName': 'Jayam', 'Affiliation': 'Department of Dentistry, All India Institute of Medical Sciences, Mangalagiri, Andhra Pradesh, India.'}, {'ForeName': 'Jazib', 'Initials': 'J', 'LastName': 'Nazeer', 'Affiliation': 'Department of Oral Pathology, Patna Dental College and Hospital, Patna, Bihar, India.'}, {'ForeName': 'Mohammad A', 'Initials': 'MA', 'LastName': 'Iqubal', 'Affiliation': 'Department of Oral Medicine and Radiology, Patna Dental College and Hospital, Patna, Bihar, India.'}, {'ForeName': 'Supriya', 'Initials': 'S', 'LastName': 'Singh', 'Affiliation': 'Private Practitioner, Department of Oral Medicine and Radiology, Patna, Bihar, India.'}]",The journal of contemporary dental practice,[] 1912,32584279,"Comparative Assessment between Ibuprofen, Chewing Gum, and Bite Wafers in Pain Control Following First Archwire Placement in Orthodontic Patients.","PURPOSE This study aimed to investigate the effectiveness of using bite wafers and chewing gum in relieving pain after the activation of the first archwire among Saudi orthodontic patients and evaluating them in comparison with ibuprofen use. Furthermore, the study investigated the effect of chewing gum and plastic wafers on the frequency of orthodontic appliance breakage. MATERIALS AND METHODS A total of 105 female patients aged 15-35 years, undergoing maxillary and mandibular fixed appliance treatment were classified randomly into three groups of 35 each. In each group, the patients were given one of the following treatments immediately after the placement of the first archwire, every 8 hours for 1 week as needed: ibuprofen (400 mg), or a viscoelastic bite wafer, or chewing gum. A visual analog scale was given to the patients to record their pain perception following initial archwire placement. In addition, the patients were asked to report any incidence of detached brackets while using the above methods. Data were analyzed using analysis of variance (ANOVA). RESULTS No statistically significant differences were found in pain perception at any time interval among the three groups. The pain experienced at bedtime and 24 hours after wire placement among different groups in the present study was found to be slightly higher with maximum intensity and the pain perception finding at different time intervals within each pain relief method was statistically significant ( p = 0.000, p < 0.05). Furthermore, ANOVA results demonstrate no significant differences in bracket detachment between the groups ( p = 0.20, p < 0.05). CONCLUSION The use of bite wafers and chewing gum was effective and comparable to ibuprofen use for pain relief following the initial activation of fixed orthodontic appliances among Saudi orthodontic patients. In addition, the study found no clinically or statistically significant differences in bracket detachment between the groups. CLINICAL SIGNIFICANCE The nondrug modalities of controlling pain such as chewing gum and/or bite wafers can be used as an alternative to ibuprofen use following the first activation of fixed orthodontic appliances.",2020,The use of bite wafers and chewing gum was effective and comparable to ibuprofen use for pain relief following the initial activation of fixed orthodontic appliances among Saudi orthodontic patients.,"['Saudi orthodontic patients and evaluating them in comparison with ibuprofen use', 'Saudi orthodontic patients', '105 female patients aged 15-35 years, undergoing maxillary and mandibular fixed appliance treatment', 'Orthodontic Patients']","['viscoelastic bite wafer, or chewing gum', 'bite wafers and chewing gum', 'Ibuprofen, Chewing Gum, and Bite Wafers', 'ibuprofen']","['pain relief', 'maximum intensity and the pain perception', 'pain', 'bracket detachment', 'pain perception']","[{'cui': 'C0332276', 'cui_str': 'Orthodontic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0024947', 'cui_str': 'Bone structure of maxilla'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0441421', 'cui_str': 'Fixed orthodontic appliance'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0005658', 'cui_str': 'Bite wound'}, {'cui': 'C0991560', 'cui_str': 'Oral Wafer'}, {'cui': 'C0008037', 'cui_str': 'Chewing Gum'}, {'cui': 'C0020740', 'cui_str': 'Ibuprofen'}]","[{'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C3714605', 'cui_str': 'Pain sensation, function'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0541879', 'cui_str': 'Detachment psychological'}]",105.0,0.0157747,The use of bite wafers and chewing gum was effective and comparable to ibuprofen use for pain relief following the initial activation of fixed orthodontic appliances among Saudi orthodontic patients.,"[{'ForeName': 'Eman I', 'Initials': 'EI', 'LastName': 'Al Shayea', 'Affiliation': 'Division of Orthodontics, Department of Pediatric Dentistry and Orthodontics, College of Dentistry, King Saud University, Riyadh, Kingdom of Saudi Arabia, Phone: +966 505420838, e-mail: e_shayea@hotmail.com.'}]",The journal of contemporary dental practice,[] 1913,32584281,"Dentin Conditioning Using Different Laser Prototypes (Er,Cr:YSGG; Er:YAG) on Bond Assessment of Resin-modified Glass Ionomer Cement.","AIM The aim of this study was to evaluate and compare various conditioning regimes (laser and conventional) on shear bond strength (SBS) of resin-modified glass ionomer cement (RMGIC) bonded to dentin. MATERIALS AND METHODS Sixty non-carious intact maxillary molars were cleaned, isolated, and randomly divided into six groups ( n = 10). Before randomization, the dentin surface was exposed and finished. Samples in group I were conditioned using Er,Cr:YSGG laser (ECYL). Specimens in group II were conditioned using Er:YAG laser (EYL), and the dentin surfaces of specimens in group III and group IV were conditioned using cavity conditioner and K930. Similarly, the samples in group V and group VI were surface treated using 17% EDTA and total etch. All samples were bonded with RMGIC following conditioning regime. For SBS testing, the samples were placed in universal testing machine. A fracture analysis of debonded surfaces was evaluated using stereomicroscope at 40× magnification. Means and standard deviations (SDs) were calculated using analysis of variance (ANOVA) and Tukey's post hoc test at a significant level of p < 0.05. RESULTS The maximum bond strength values were observed in group VI total etch (23.85 ± 3.67). The lowest bond strength was displayed in laser dentin group II conditioned by EYL (11.65 ± 2.77). Dentin conditioned with ECYL, cavity conditioner, K930 conditioner, and 17% ethylenediaminetetraacetic acid (EDTA) were found to be comparable, p > 0.05. Cohesive failure was dominant among experimental groups. CONCLUSION Er,Cr:YSGG laser has a potential to be recommended for dentin conditioning prior to application of RMGIC. CLINICAL SIGNIFICANCE Dentin conditioning enhances adhesion of RMGIC for improved prognosis and treatment outcome.",2020,The lowest bond strength was displayed in laser dentin group II conditioned by EYL (11.65 ± 2.77).,"['Sixty non-carious intact maxillary molars', 'Resin-modified Glass Ionomer Cement']","['various conditioning regimes (laser and conventional', 'Dentin Conditioning Using Different Laser Prototypes', 'conditioned using Er:YAG laser (EYL', 'ethylenediaminetetraacetic acid (EDTA', 'Er,Cr', 'I were conditioned using Er,Cr:YSGG laser (ECYL', 'YSGG', 'YSGG laser']","['maximum bond strength values', 'shear bond strength (SBS', 'Means and standard deviations (SDs', 'lowest bond strength']","[{'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C0024947', 'cui_str': 'Bone structure of maxilla'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}, {'cui': 'C0035191', 'cui_str': 'Resins, Plant'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0017597', 'cui_str': 'Glass-ionomer dental material'}]","[{'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0011429', 'cui_str': 'Dentin structure'}, {'cui': 'C0457903', 'cui_str': 'Erbium:YAG laser device'}, {'cui': 'C0013618', 'cui_str': 'Edetic Acid'}, {'cui': 'C0879167', 'cui_str': 'Yttrium-Scandium-Gallium Garnet Lasers'}]","[{'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0028758', 'cui_str': 'Bonding (Psychology)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0175735', 'cui_str': 'Scissors'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0037506', 'cui_str': 'Sodium lauryl sulfate'}, {'cui': 'C0205251', 'cui_str': 'Low'}]",60.0,0.0338134,The lowest bond strength was displayed in laser dentin group II conditioned by EYL (11.65 ± 2.77).,"[{'ForeName': 'Fahad', 'Initials': 'F', 'LastName': 'Alkhudhairy', 'Affiliation': 'Department of Restorative Dental Sciences, College of Dentistry, King Saud University, Riyadh, Kingdom of Saudi Arabia, Phone: +966 559917888, e-mail: falkhudhairy@ksu.edu.sa.'}]",The journal of contemporary dental practice,[] 1914,32579567,School-based intervention to address self-regulation and executive functioning in children attending primary schools in remote Australian Aboriginal communities.,"Executive functioning and self-regulation influence a range of outcomes across the life course including physical and mental health, educational success, and employment. Children prenatally exposed to alcohol or early life trauma (ELT) are at higher risk of impairment of these skills and may require intervention to address self-regulation deficits. Researchers partnered with the local Aboriginal health organization and schools to develop and pilot a manualized version of the Alert Program® in the Fitzroy Valley, north Western Australia, a region with documented high rates of fetal alcohol spectrum disorder and ELT. This self-controlled cluster randomized trial evaluated the effect of an 8-week Alert Program® intervention on children's executive functioning and self-regulation skills. Following parent or caregiver consent (referred to hereafter as parent), 271 students were enrolled in the study. This reflects a 75% participation rate and indicates the strong community support that exists for the study. Teachers from 26 primary school classrooms across eight Fitzroy Valley schools received training to deliver eight, one-hour Alert Program® lessons over eight-weeks to students. Student outcomes were measured by parent and teacher ratings of children's behavioral, emotional, and cognitive regulation. The mean number of lessons attended by children was 4.2. Although no significant improvements to children's executive functioning skills or behavior were detected via the teacher-rated measures as hypothesized, statistically significant improvements were noted on parent-rated measures of executive functioning and behavior. The effectiveness of future self-regulation programs may be enhanced through multimodal delivery through home, school and community based settings to maximize children's exposure to the intervention. Despite mixed findings of effect, this study was an important first step in adapting and evaluating the Alert Program® for use in remote Australian Aboriginal community schools, where access to self-regulation interventions is limited.",2020,"Although no significant improvements to children's executive functioning skills or behavior were detected via the teacher-rated measures as hypothesized, statistically significant improvements were noted on parent-rated measures of executive functioning and behavior.","['Following parent or caregiver consent (referred to hereafter as parent), 271 students were enrolled in the study', 'children attending primary schools in remote Australian Aboriginal communities', ""children's executive functioning and self-regulation skills"", 'Teachers from 26 primary school classrooms across eight Fitzroy Valley schools', 'remote Australian Aboriginal community schools']","['alcohol or early life trauma (ELT', 'School-based intervention to address self-regulation and executive functioning', '8-week Alert Program® intervention']","[""parent and teacher ratings of children's behavioral, emotional, and cognitive regulation"", 'executive functioning and behavior', ""children's executive functioning skills or behavior"", 'physical and mental health, educational success, and employment']","[{'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0557296', 'cui_str': 'Attending primary school'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0684274', 'cui_str': 'Self-control'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0033145', 'cui_str': 'Primary school'}, {'cui': 'C0563004', 'cui_str': 'Valley'}, {'cui': 'C0036375', 'cui_str': 'School'}]","[{'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0376649', 'cui_str': 'Addresses'}, {'cui': 'C0684274', 'cui_str': 'Self-control'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0014003', 'cui_str': 'Employment'}]",271.0,0.0226753,"Although no significant improvements to children's executive functioning skills or behavior were detected via the teacher-rated measures as hypothesized, statistically significant improvements were noted on parent-rated measures of executive functioning and behavior.","[{'ForeName': 'Bree', 'Initials': 'B', 'LastName': 'Wagner', 'Affiliation': 'Alcohol and Pregnancy and Fetal Alcohol Spectrum Disorder Research Team, Telethon Kids Institute, The University of Western Australia, Perth, Western Australia, Australia.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Latimer', 'Affiliation': 'Sydney School of Public Health, Faculty of Medicine and Health, The University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Adams', 'Affiliation': 'Alcohol and Pregnancy and Fetal Alcohol Spectrum Disorder Research Team, Telethon Kids Institute, The University of Western Australia, Perth, Western Australia, Australia.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Carmichael Olson', 'Affiliation': ""Seattle Children's Research Institute, Seattle, Washington, United States of America.""}, {'ForeName': 'Martyn', 'Initials': 'M', 'LastName': 'Symons', 'Affiliation': 'National Health and Medical Research Council FASD Research Australia Centre of Research Excellence, Perth, Western Australia, Australia.'}, {'ForeName': 'Trevor G', 'Initials': 'TG', 'LastName': 'Mazzucchelli', 'Affiliation': 'Child and Family Research Group, School of Psychology, Curtin University, Perth, Western Australia, Australia.'}, {'ForeName': 'Tracy', 'Initials': 'T', 'LastName': 'Jirikowic', 'Affiliation': 'Division of Occupational Therapy, Department of Rehabilitation Medicine, University of Washington School of Medicine, Seattle, Washington, United States of America.'}, {'ForeName': 'Rochelle', 'Initials': 'R', 'LastName': 'Watkins', 'Affiliation': 'National Health and Medical Research Council FASD Research Australia Centre of Research Excellence, Perth, Western Australia, Australia.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'Cross', 'Affiliation': 'Telethon Kids Institute, The University of Western Australia, Perth, Western Australia, Australia.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Carapetis', 'Affiliation': 'Telethon Kids Institute, The University of Western Australia, Perth, Western Australia, Australia.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Boulton', 'Affiliation': 'The University of Newcastle, Newcastle, New South Wales, Australia.'}, {'ForeName': 'Edie', 'Initials': 'E', 'LastName': 'Wright', 'Affiliation': 'Western Australian Department of Education Kimberley Education Region, Broome, Western Australia, Australia.'}, {'ForeName': 'Tracy', 'Initials': 'T', 'LastName': 'McRae', 'Affiliation': 'Alcohol and Pregnancy and Fetal Alcohol Spectrum Disorder Research Team, Telethon Kids Institute, The University of Western Australia, Perth, Western Australia, Australia.'}, {'ForeName': 'Maureen', 'Initials': 'M', 'LastName': 'Carter', 'Affiliation': 'Nindilingarri Cultural Health Services, Fitzroy Crossing, Western Australia, Australia.'}, {'ForeName': 'James P', 'Initials': 'JP', 'LastName': 'Fitzpatrick', 'Affiliation': 'Alcohol and Pregnancy and Fetal Alcohol Spectrum Disorder Research Team, Telethon Kids Institute, The University of Western Australia, Perth, Western Australia, Australia.'}]",PloS one,['10.1371/journal.pone.0234895'] 1915,32442153,Evaluating Engagement in a Digital and Dietetic Intervention Promoting Healthy Weight Gain in Pregnancy: Mixed Methods Study.,"BACKGROUND Early excess and inadequate gestational weight gain (GWG) have been associated with negative outcomes for mother and child. The use of digital media to deliver pregnancy lifestyle interventions is increasing, but there is little data on participant engagement. The Pregnancy Lifestyle Activity and Nutrition (PLAN) intervention pilot study was an electronic health and dietetic-delivered intervention program promoting healthy GWG in early pregnancy. OBJECTIVE This study aims to explore the interactions of participants with the program and to assess its acceptability. METHODS This study uses both quantitative and qualitative methods using data from parent randomized controlled trial (ACTRN12617000725369). Quantitative data from 22 participants in the intervention arm who completed the study provided measures of the interactions participants had with the digital components of the program and with dietetic consultations. A descriptive qualitative analysis employed semistructured interviews with 9 participants to elicit views on the acceptability of the intervention and its components. RESULTS The electronic delivery of information and recording of weight from 8 to 20 weeks of gestation were universally accepted. Component (face-to-face dietitian, weight tracker, website information delivery, and SMS goal prompting) acceptability and engagement differed between individuals. A total of 4 key themes emerged from the qualitative analysis: supporting lifestyle change, component acceptability and value, delivery platforms, and engagement barriers. CONCLUSIONS The PLAN intervention and its delivery via a blend of personal dietetic consultations and digital program delivery was found to be acceptable and valuable to pregnant women. Individuals responded differently to various components, emphasizing the importance of including women in the development of lifestyle interventions and allowing participants to choose and tailor programs. Larger randomized controlled trials using these insights in a broader section of the community are needed to inform the iterative development of practical, time-efficient, and cost-effective ways of supporting optimal GWG with the potential to optimize outcomes for pregnant women and their child.",2020,The PLAN intervention and its delivery via a blend of personal dietetic consultations and digital program delivery was found to be acceptable and valuable to pregnant women.,"['pregnant women and their child', 'pregnant women', ""Women's Engagement With Pregnancy Lifestyle Activity and Nutrition"", '22 participants in the intervention arm who completed the study provided measures of the interactions participants had with the digital components of the program and with dietetic consultations']","['Electronic Health and Dietetic Intervention', 'electronic health and dietetic-delivered intervention program promoting healthy GWG']",[],"[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0012180', 'cui_str': 'Dietetics'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}]","[{'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0012180', 'cui_str': 'Dietetics'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C1398625', 'cui_str': 'Maternal Weight Gain'}]",[],22.0,0.0728469,The PLAN intervention and its delivery via a blend of personal dietetic consultations and digital program delivery was found to be acceptable and valuable to pregnant women.,"[{'ForeName': 'Jane C', 'Initials': 'JC', 'LastName': 'Willcox', 'Affiliation': 'La Trobe University, Bundoora, Australia.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Chai', 'Affiliation': 'Telethon Kids Institute, Perth, Australia.'}, {'ForeName': 'Lawrence J', 'Initials': 'LJ', 'LastName': 'Beilin', 'Affiliation': 'The University of Western Australia, Perth, Australia.'}, {'ForeName': 'Susan L', 'Initials': 'SL', 'LastName': 'Prescott', 'Affiliation': 'The University of Western Australia, Perth, Australia.'}, {'ForeName': 'Desiree', 'Initials': 'D', 'LastName': 'Silva', 'Affiliation': 'Joondalup Health Campus, Shenton Avenue, Perth, Australia.'}, {'ForeName': 'Cliff', 'Initials': 'C', 'LastName': 'Neppe', 'Affiliation': 'Joondalup Health Campus, Shenton Avenue, Perth, Australia.'}, {'ForeName': 'Rae-Chi', 'Initials': 'RC', 'LastName': 'Huang', 'Affiliation': 'Telethon Kids Institute, Perth, Australia.'}]",Journal of medical Internet research,['10.2196/17845'] 1916,32442154,Feasibility and Utility of mHealth for the Remote Monitoring of Parkinson Disease: Ancillary Study of the PD_manager Randomized Controlled Trial.,"BACKGROUND Mobile health, predominantly wearable technology and mobile apps, have been considered in Parkinson disease to provide valuable ecological data between face-to-face visits and improve monitoring of motor symptoms remotely. OBJECTIVE We explored the feasibility of using a technology-based mHealth platform comprising a smartphone in combination with a smartwatch and a pair of smart insoles, described in this study as the PD_manager system, to collect clinically meaningful data. We also explored outcomes and disease-related factors that are important determinants to establish feasibility. Finally, we further validated a tremor evaluation method with data collected while patients performed their daily activities. METHODS PD_manager trial was an open-label parallel group randomized study.The mHealth platform consists of a wristband, a pair of sensor insoles, a smartphone (with dedicated mobile Android apps) and a knowledge platform serving as the cloud backend. Compliance was assessed with statistical analysis and the factors affecting it using appropriate regression analysis. The correlation of the scores of our previous algorithm for tremor evaluation and the respective Unified Parkinson's Disease Rating Scale estimations by clinicians were explored. RESULTS Of the 75 study participants, 65 (87%) completed the protocol. They used the PD_manager system for a median 11.57 (SD 3.15) days. Regression analysis suggests that the main factor associated with high use was caregivers' burden. Motor Aspects of Experiences of Daily Living and patients' self-rated health status also influence the system's use. Our algorithm provided clinically meaningful data for the detection and evaluation of tremor. CONCLUSIONS We found that PD patients, regardless of their demographics and disease characteristics, used the system for 11 to 14 days. The study further supports that mHealth can be an effective tool for the ecologically valid, passive, unobtrusive monitoring and evaluation of symptoms. Future studies will be required to demonstrate that an mHealth platform can improve disease management and care. TRIAL REGISTRATION ISRCTN Registry ISRCTN17396879; http://www.isrctn.com/ISRCTN17396879. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID) RR2-10.1186/s13063-018-2767-4.",2020,"The correlation of the scores of our previous algorithm for tremor evaluation and the respective Unified Parkinson's Disease Rating Scale estimations by clinicians were explored. ","['Of the 75 study participants, 65 (87%) completed the protocol', 'Parkinson Disease']",['technology-based mHealth platform'],[],"[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}]","[{'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}]",[],75.0,0.0514528,"The correlation of the scores of our previous algorithm for tremor evaluation and the respective Unified Parkinson's Disease Rating Scale estimations by clinicians were explored. ","[{'ForeName': 'Dimitris', 'Initials': 'D', 'LastName': 'Gatsios', 'Affiliation': 'Department of Neurology, Medical School, University of Ioannina, Ioannina, Greece.'}, {'ForeName': 'Angelo', 'Initials': 'A', 'LastName': 'Antonini', 'Affiliation': 'Department of Neuroscience, University of Padua, Padua, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Gentile', 'Affiliation': 'Department of Neuroscience, University of Padua, Padua, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Marcante', 'Affiliation': 'San Camillo Hospital Istituto Di Ricovero e Cura a Carattere Scientifico, Venice, Italy.'}, {'ForeName': 'Clelia', 'Initials': 'C', 'LastName': 'Pellicano', 'Affiliation': 'Laboratory of Neuropsychiatry, Fondazione Santa Lucia Istituto Di Ricovero e Cura a Carattere Scientifico, Rome, Italy.'}, {'ForeName': 'Lucia', 'Initials': 'L', 'LastName': 'Macchiusi', 'Affiliation': 'Laboratory of Neuropsychiatry, Fondazione Santa Lucia Istituto Di Ricovero e Cura a Carattere Scientifico, Rome, Italy.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Assogna', 'Affiliation': 'Laboratory of Neuropsychiatry, Fondazione Santa Lucia Istituto Di Ricovero e Cura a Carattere Scientifico, Rome, Italy.'}, {'ForeName': 'Gianfranco', 'Initials': 'G', 'LastName': 'Spalletta', 'Affiliation': 'Laboratory of Neuropsychiatry, Fondazione Santa Lucia Istituto Di Ricovero e Cura a Carattere Scientifico, Rome, Italy.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Gage', 'Affiliation': 'Surrey Health Economics Centre, Department of Clinical and Experimental Medicine, University of Surrey, Guildford, United Kingdom.'}, {'ForeName': 'Morro', 'Initials': 'M', 'LastName': 'Touray', 'Affiliation': 'Surrey Health Economics Centre, Department of Clinical and Experimental Medicine, University of Surrey, Guildford, United Kingdom.'}, {'ForeName': 'Lada', 'Initials': 'L', 'LastName': 'Timotijevic', 'Affiliation': 'School of Psychology, Faculty of Health and Medical Sciences, University of Surrey, Guildford, United Kingdom.'}, {'ForeName': 'Charo', 'Initials': 'C', 'LastName': 'Hodgkins', 'Affiliation': 'School of Psychology, Faculty of Health and Medical Sciences, University of Surrey, Guildford, United Kingdom.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Chondrogiorgi', 'Affiliation': 'Department of Neurology, Medical School, University of Ioannina, Ioannina, Greece.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Rigas', 'Affiliation': 'Unit of Medical Technology and Intelligent Information System, Department of Materials Science and Engineering, University of Ioannina, Ioannina, Greece.'}, {'ForeName': 'Dimitrios I', 'Initials': 'DI', 'LastName': 'Fotiadis', 'Affiliation': 'Unit of Medical Technology and Intelligent Information System, Department of Materials Science and Engineering, University of Ioannina, Ioannina, Greece.'}, {'ForeName': 'Spyridon', 'Initials': 'S', 'LastName': 'Konitsiotis', 'Affiliation': 'Department of Neurology, Medical School, University of Ioannina, Ioannina, Greece.'}]",JMIR mHealth and uHealth,['10.2196/16414'] 1917,32461626,Timing of milk expression following delivery in mothers delivering preterm very low birth weight infants: a randomized trial.,"OBJECTIVE To determine the effect of timing of expression initiation on mother's own milk production and time to secretory activation in mothers of preterm infants. STUDY DESIGN 180 mothers delivering infants ≤1500 grams and ≤32 weeks gestation were randomized to begin expression within 60 (early), 61-180 (intermediate) or 181-360 (late) minutes following delivery. Milk volume was measured on days 1-7 and weekly for 6 weeks. Time to secretory activation was determined through self-report. RESULTS The late group produced more milk than the early group in the first 3 days (p = 0.015-0.031) and over 6 weeks (p = 0.045). The late group had more expressions on day 1 (early: p = 0.049; intermediate; p = 0.048). CONCLUSION Initiation of expression at 181-360 min following delivery was associated with increased milk production for 6 weeks following delivery. Further research is needed to determine the effect of expression frequency on milk production in the first days following birth.",2020,The late group produced more milk than the early group in the first 3 days (p = 0.015-0.031) and over 6 weeks (p = 0.045).,"['mothers of preterm infants', 'mothers delivering preterm very low birth weight infants', '180 mothers delivering infants', '≤1500 grams and ≤32 weeks gestation']",[],"['milk production', 'Milk volume', 'Time to secretory activation']","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0566687', 'cui_str': 'Mother delivered'}, {'cui': 'C0282667', 'cui_str': 'Very low birth weight infant'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0439208', 'cui_str': 'g'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}]",[],"[{'cui': 'C0558187', 'cui_str': 'Lactation established'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",180.0,0.11443,The late group produced more milk than the early group in the first 3 days (p = 0.015-0.031) and over 6 weeks (p = 0.045).,"[{'ForeName': 'Leslie A', 'Initials': 'LA', 'LastName': 'Parker', 'Affiliation': 'University of Florida, Gainesville, FL, USA. Parkela@ufl.edu.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Sullivan', 'Affiliation': 'University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Charlene', 'Initials': 'C', 'LastName': 'Kruger', 'Affiliation': 'University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Mueller', 'Affiliation': 'Medical University of South Carolina, Charleston, SC, USA.'}]",Journal of perinatology : official journal of the California Perinatal Association,['10.1038/s41372-020-0688-z'] 1918,32580919,A randomized controlled trial of antibody response to 2018-19 cell-based vs. egg-based quadrivalent inactivated influenza vaccine in children.,"BACKGROUND Current influenza vaccine effectiveness (VE) improvement efforts focus on minimizing egg adaptation mutations during manufacture. This study compared immune response of two FDA-approved quadrivalent inactivated influenza vaccines in an unblinded randomized controlled trial. METHODS Participants were 144 community dwelling, healthy children/adolescents aged 4-20 years, randomized 1:1 in blocks of 4 to a vaccine grown in cell culture (ccIIV4 [Flucelvax®]; n = 85); or in egg medium (IIV4 [Fluzone ®]; n = 83). Blood was drawn at day 0 prevaccination and at day 28 (19-35 days) post vaccination. Hemagglutination inhibition (HI) assays against A/H1N1 and both B strains and microneutralization (MN) assays against egg-based and cell-based A/H3N2 strains were conducted. The primary outcome measure was seroconversion (day 28/day 0 titer ratio ≥ 4 with day 28 titer ≥ 40). Secondary outcomes were elevated titers (day 28 HI titer ≥ 1:110), geometric mean titers (GMTs) and mean fold rise (MFR) in titers. Outcomes were compared for 74 ccIIV4 recipients and 70 IIV4 recipients, and for those vaccinated and unvaccinated the previous year. Only the HI and MN laboratory analysis team was blinded to group assignment. RESULTS In this racially diverse (81% non-white) group of children with a median age of 14 years, baseline demographics did not differ between vaccine groups. At day 0, half or more in each vaccine group had elevated HI or MN titers. Low seroconversion rates (14%-35%) were found; they did not differ between groups. Among 2018-19 ccIIV4 recipients, those unvaccinated in the previous season showed significantly higher MFR against A/H1N1 and A/H3N2 cell-grown virus than the previously vaccinated. Similar results were found for MFR against B/Victoria among 2018-2019 IIV4 recipients. CONCLUSION In mostly older children with high baseline titers, no differences in seroconversion or other measures of antibody titers were found between ccIIV4 and IIV4 recipients against egg- and cell-grown influenza vaccine viruses. CLINICAL TRIALS NO NCT03614975.",2020,"In mostly older children with high baseline titers, no differences in seroconversion or other measures of antibody titers were found between ccIIV4 and IIV4 recipients against egg- and cell-grown influenza vaccine viruses. ","['≥\xa04 with day 28 titer', 'Participants were 144 community dwelling, healthy children/adolescents aged 4-20\xa0years', 'children']","['2018-19 cell-based vs. egg-based quadrivalent inactivated influenza vaccine', 'vaccine grown in cell culture (ccIIV4 [Flucelvax®]; n\xa0=\xa085); or in egg medium (IIV4 [Fluzone ®', 'FDA-approved quadrivalent inactivated influenza vaccines', 'Hemagglutination inhibition (HI) assays against A/H1N1 and both B strains and microneutralization (MN) assays']","['Low seroconversion rates', 'MFR against B/Victoria', 'antibody titers', 'titer ratio', 'elevated HI or MN titers', 'elevated titers (day 28 HI titer\xa0≥\xa01:110), geometric mean titers (GMTs) and mean fold rise (MFR', 'seroconversion (day 28/day 0']","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0475208', 'cui_str': 'Titer'}, {'cui': 'C4760627', 'cui_str': '144'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0686744', 'cui_str': 'Well child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013710', 'cui_str': 'Eggs (edible)'}, {'cui': 'C0021403', 'cui_str': 'Influenza virus vaccine'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0007585', 'cui_str': 'Cell Culture'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0041714', 'cui_str': 'United States Food, Drug Administration'}, {'cui': 'C0205540', 'cui_str': 'Approved'}, {'cui': 'C0018904', 'cui_str': 'Hemagglutination inhibition assay'}, {'cui': 'C0005507', 'cui_str': 'Bioassay'}, {'cui': 'C0580264', 'cui_str': 'H1N1'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C4042908', 'cui_str': 'Seroconversion'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0185026', 'cui_str': 'Plication'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0042645', 'cui_str': 'Victoria'}, {'cui': 'C0474643', 'cui_str': 'Antibody titer measurement'}, {'cui': 'C0475208', 'cui_str': 'Titer'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0018904', 'cui_str': 'Hemagglutination inhibition assay'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",144.0,0.30326,"In mostly older children with high baseline titers, no differences in seroconversion or other measures of antibody titers were found between ccIIV4 and IIV4 recipients against egg- and cell-grown influenza vaccine viruses. ","[{'ForeName': 'Krissy K', 'Initials': 'KK', 'LastName': 'Moehling', 'Affiliation': 'Department of Family Medicine, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Richard K', 'Initials': 'RK', 'LastName': 'Zimmerman', 'Affiliation': 'Department of Family Medicine, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Mary Patricia', 'Initials': 'MP', 'LastName': 'Nowalk', 'Affiliation': 'Department of Family Medicine, University of Pittsburgh, Pittsburgh, PA, USA. Electronic address: tnowalk@pitt.edu.'}, {'ForeName': 'Chyongchiou', 'Initials': 'C', 'LastName': 'Jeng Lin', 'Affiliation': 'Department of Family Medicine, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Judith M', 'Initials': 'JM', 'LastName': 'Martin', 'Affiliation': 'Department of Pediatrics, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'John F', 'Initials': 'JF', 'LastName': 'Alcorn', 'Affiliation': 'Department of Pediatrics, University of Pittsburgh, Pittsburgh, PA, USA; Department of Immunology, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Susick', 'Affiliation': 'Department of Family Medicine, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Burroughs', 'Affiliation': 'National Center Immunizations and Respiratory Diseases, Centers for Disease Control and Prevention, Atlanta GA, USA.'}, {'ForeName': 'Crystal', 'Initials': 'C', 'LastName': 'Holiday', 'Affiliation': 'National Center Immunizations and Respiratory Diseases, Centers for Disease Control and Prevention, Atlanta GA, USA.'}, {'ForeName': 'Brendan', 'Initials': 'B', 'LastName': 'Flannery', 'Affiliation': 'National Center Immunizations and Respiratory Diseases, Centers for Disease Control and Prevention, Atlanta GA, USA.'}, {'ForeName': 'Min Z', 'Initials': 'MZ', 'LastName': 'Levine', 'Affiliation': 'National Center Immunizations and Respiratory Diseases, Centers for Disease Control and Prevention, Atlanta GA, USA.'}]",Vaccine,['10.1016/j.vaccine.2020.06.023'] 1919,32445277,Exhalation delivery system with fluticasone improves quality of life and health status: pooled analysis of phase 3 trials NAVIGATE I and II.,"BACKGROUND Chronic rhinosinusitis with or without nasal polyps (CRSwNP/CRSsNP) seriously impairs health-related quality of life (HRQoL). This analysis describes the impact of the exhalation delivery system with fluticasone (EDS-FLU) on HRQoL, assessed by the 36-item Short-Form Health Survey version 2 (SF-36v2), and on utilities, assessed via the Short-Form 6-Dimension (SF-6D), in patients with CRSwNP. METHODS Post hoc analysis of pooled randomized clinical trial data (NAVIGATE I and II; N = 643) to examine change from baseline in SF-36v2 and SF-6D at end-of-double-blind (EODB: 16 weeks) and end-of-open-label (EOOL: 24 weeks; following 8 weeks of open-label treatment) for EDS-FLU vs placebo (EDS-PBO). Baseline characteristics predictive of change in SF-36 and SF-6D scores were assessed. RESULTS Mean baseline SF-36v2 scores were below population norms. At EODB, mean improvement was greater for all SF-36v2 domain and component scores with EDS-FLU (range: 2.9 [physical functioning] to 5.11 [bodily pain {BP}]) vs EDS-PBO (range: 0.81 [mental health] to 2.87 [BP]) (each comparison p < 0.01); physical and mental component score improvements within the EDS-FLU group exceeded the minimal clinically important difference (MCID). Clinically meaningful and statistically significant improvements in SF-6D utility scores were seen in EDS-FLU-treated patients compared to EDS-PBO-treated patients (0.058 vs 0.023, respectively, p < 0.001). At EOOL, SF-36v2 and SF-6D mean scores were at or above population norms, with clinically meaningful and statistically significant improvements from baseline. CONCLUSION In this pooled analysis of 2 large pivotal EDS-FLU trials, health domain and health utilities improvements were significantly greater with EDS-FLU than EDS-PBO and were comparable to population norms.",2020,"Clinically meaningful and statistically significant improvements in SF-6D utility scores were seen in EDS-FLU-treated patients compared to EDS-PBO-treated patients (0.058 vs 0.023, respectively, p < 0.001).",['patients with CRSwNP'],"['nasal polyps (CRSwNP/CRSsNP', 'EDS-FLU vs placebo (EDS-PBO', 'fluticasone (EDS-FLU', 'fluticasone']","['SF-6D utility scores', 'quality of life and health status', 'At EOOL, SF-36v2 and SF-6D mean scores', 'SF-36 and SF-6D scores', 'Mean baseline SF-36v2 scores', 'physical and mental component score improvements']","[{'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0027430', 'cui_str': 'Polyp of nasal cavity'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0449914', 'cui_str': 'Delivery system'}, {'cui': 'C0082607', 'cui_str': 'fluticasone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0021400', 'cui_str': 'Influenza'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449432', 'cui_str': 'Component'}]",,0.118395,"Clinically meaningful and statistically significant improvements in SF-6D utility scores were seen in EDS-FLU-treated patients compared to EDS-PBO-treated patients (0.058 vs 0.023, respectively, p < 0.001).","[{'ForeName': 'Zachary M', 'Initials': 'ZM', 'LastName': 'Soler', 'Affiliation': 'Division of Rhinology and Sinus Surgery, Department of Otolaryngology-Head and Neck Surgery, Medical University of South Carolina, Charleston, SC.'}, {'ForeName': 'Sam', 'Initials': 'S', 'LastName': 'Colman', 'Affiliation': 'OptiNose US, Inc., Yardley, PA.'}, {'ForeName': 'Fulton F', 'Initials': 'FF', 'LastName': 'Velez', 'Affiliation': 'Covance Market Access Services Inc, Gaithersburg, MD.'}, {'ForeName': 'Rodney J', 'Initials': 'RJ', 'LastName': 'Schlosser', 'Affiliation': 'Division of Rhinology and Sinus Surgery, Department of Otolaryngology-Head and Neck Surgery, Medical University of South Carolina, Charleston, SC.'}]",International forum of allergy & rhinology,['10.1002/alr.22573'] 1920,32580032,Design of a cluster-randomized trial of the effectiveness and cost-effectiveness of metformin on prevention of type 2 diabetes among prediabetic Mexican adults (the PRuDENTE initiative of Mexico City).,"INTRODUCTION Type 2 diabetes (T2D) is a global epidemic, and nations are struggling to implement effective healthcare strategies to reduce the burden. While efficacy studies demonstrate that metformin can reduce incident T2D by half among younger, obese adults with prediabetes, its real-world effectiveness are understudied, and its use for T2D prevention in primary care is low. We describe the design of a pragmatic trial to evaluate the incremental effectiveness of metformin, as an adjunct to a simple lifestyle counseling. METHODS The ""Prevención de la Diabetes con Ejercicio, Nutrición y Tratamiento"" [Diabetes Prevention with Exercise, Nutrition and Treatment; PRuDENTE, (Spanish acronym)] is a cluster-randomized trial in Mexico City's public primary healthcare system. The study randomly assigns 51 clinics to deliver one of two interventions for 36 months: 1) lifestyle only; 2) lifestyle plus metformin, to 3060 patients ages 30-65 with impaired fasting glucose and obesity. The primary endpoint is incident T2D (fasting glucose ≥126 mg/dL, or HbA1c ≥6.5%). We will also measure a range of implementation-related process outcomes at the clinic-, clinician- and patient-levels to inform interpretations of effectiveness and enable efforts to refine, adapt, adopt and disseminate the model. We will also estimate the cost-effectiveness of metformin as an adjunct to lifestyle counseling in Mexico. DISCUSSION Findings from this pragmatic trial will generate new translational knowledge in Mexico and beyond, both with respect to metformin's real-world effectiveness among an 'at-risk' population, and uncovering facilitators and barriers to the reach, adoption and implementation of metformin preventive therapy in public primary care settings. TRIAL REGISTRATION This trial is registered at Clinicaltrials.gov (NCT03194009).",2020,Nutrición y,"['prediabetic Mexican adults (the PRuDENTE initiative of Mexico City', '3060 patients ages 30-65 with impaired fasting glucose and obesity', 'Nutrición y']","['lifestyle only; 2) lifestyle plus metformin', 'metformin']","['incident T2D (fasting glucose ≥126\u202fmg/dL, or HbA1c ≥6.5']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0424093', 'cui_str': 'Initiative'}, {'cui': 'C0025885', 'cui_str': 'Mexico'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C1272092', 'cui_str': 'Impaired fasting glycaemia'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}]","[{'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}]",3060.0,0.0429361,Nutrición y,"[{'ForeName': 'Luis A', 'Initials': 'LA', 'LastName': 'Rodríguez', 'Affiliation': 'Department of Epidemiology & Biostatistics, University of California, San Francisco, San Francisco, CA, USA. Electronic address: Luis.Rodriguez@ucsf.edu.'}, {'ForeName': 'Simón', 'Initials': 'S', 'LastName': 'Barquera', 'Affiliation': 'Nutrition and Health Research Center, National Institute of Public Health, Cuernavaca, Mexico.'}, {'ForeName': 'Carlos A', 'Initials': 'CA', 'LastName': 'Aguilar-Salinas', 'Affiliation': 'Division of Nutrition, Salvador Zubiran National Institute of Medical Sciences and Nutrition, Mexico City, Mexico.'}, {'ForeName': 'Jaime', 'Initials': 'J', 'LastName': 'Sepúlveda-Amor', 'Affiliation': 'Department of Epidemiology & Biostatistics, University of California, San Francisco, San Francisco, CA, USA; Institute for Global Health Sciences, University of California, San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Luz María', 'Initials': 'LM', 'LastName': 'Sánchez-Romero', 'Affiliation': 'Nutrition and Health Research Center, National Institute of Public Health, Cuernavaca, Mexico.'}, {'ForeName': 'Edgar', 'Initials': 'E', 'LastName': 'Denova-Gutiérrez', 'Affiliation': 'Nutrition and Health Research Center, National Institute of Public Health, Cuernavaca, Mexico.'}, {'ForeName': 'Nydia', 'Initials': 'N', 'LastName': 'Balderas', 'Affiliation': 'Nutrition and Health Research Center, National Institute of Public Health, Cuernavaca, Mexico.'}, {'ForeName': 'Lizbeth', 'Initials': 'L', 'LastName': 'Moreno-Loaeza', 'Affiliation': 'Research Unit on Metabolic Diseases, Salvador Zubiran National Institute of Medical Sciences and Nutrition, Mexico City, Mexico; Medical, Dental and Health Sciences, National Autonomous University of Mexico, Mexico City, Mexico.'}, {'ForeName': 'Margaret A', 'Initials': 'MA', 'LastName': 'Handley', 'Affiliation': 'Department of Epidemiology & Biostatistics, University of California, San Francisco, San Francisco, CA, USA; Division of General Internal Medicine at San Francisco General Hospital, University of California, San Francisco, San Francisco, CA, USA; UCSF Center for Vulnerable Populations, San Francisco General Hospital, San Francisco, CA, USA.'}, {'ForeName': 'Sanjay', 'Initials': 'S', 'LastName': 'Basu', 'Affiliation': 'Department of Medicine, Stanford University, Palo Alto, CA, USA.'}, {'ForeName': 'Oliva', 'Initials': 'O', 'LastName': 'López-Arellano', 'Affiliation': 'Ministry of Health, Mexico City, Mexico.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Gallardo-Hernández', 'Affiliation': 'Ministry of Health, Mexico City, Mexico.'}, {'ForeName': 'Dean', 'Initials': 'D', 'LastName': 'Schillinger', 'Affiliation': 'Division of General Internal Medicine at San Francisco General Hospital, University of California, San Francisco, San Francisco, CA, USA; UCSF Center for Vulnerable Populations, San Francisco General Hospital, San Francisco, CA, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106067'] 1921,32445850,Comparison of the Effects of Vapocoolant Spray and Topical Anesthetic Cream on Pain During Intraarticular Injection of the Shoulder: A Randomized Double-Blind Controlled Trial.,"OBJECTIVE This study was performed to compare the effects of a vapocoolant spray and a eutectic mixture of local anesthetics (EMLA) cream on reducing pain during intra-articular (IA) injection of the shoulder. DESIGN Double-blind randomized placebo-controlled clinical trial. SETTING University hospital. PARTICIPANTS Patients (N=63) who underwent IA injection of the shoulder joint were randomized into the spray group, EMLA group, or placebo group. INTERVENTION Placebo cream+vapocoolant spray (spray group), EMLA cream+placebo spray (EMLA group), or placebo cream+placebo spray (placebo group) before IA injection. MAIN OUTCOME MEASURES A 100-mm visual analog scale (VAS) for injection pain and 5-point Likert scales for participant satisfaction and preference for repeated use were administered immediately after IA injection. RESULTS The VAS scores for pain during IA injection were 30.0 (95% CI, 19.7-41.2) in the spray group, 50.0 (95% CI, 37.7-63.0) in the EMLA group, and 53.8 (95% CI, 41.6-65.0) in the placebo group (F=6.403, P<.01). The spray group showed significantly better Likert scale scores than the placebo group for participant satisfaction (P=.003) and preference for repeated use (P<.001). CONCLUSIONS Vapocoolant spray was effective in reducing pain during IA injection of the shoulder.",2020,"The spray group showed significantly better Likert scale scores than the placebo group for participant satisfaction (P = 0.003) and preference for repeated use (P < 0.001). ","['Sixty-three patients who underwent IA injection of the shoulder joint', 'Pain during Intraarticular Injection of the Shoulder', 'University hospital']","['EMLA', 'vapocoolant spray and an eutectic mixture of local anesthetics (EMLA) cream', 'Placebo cream + vapocoolant spray (spray group), EMLA cream + placebo spray (EMLA group), or placebo cream + placebo spray (placebo', 'Vapocoolant spray', 'Vapocoolant Spray and Topical Anesthetic Cream', 'placebo']","['pain during intraarticular (IA) injection', '100-mm visual analog scale (VAS) for injection pain and 5-point Likert scales for participant satisfaction and preference for repeated use', 'pain', 'VAS scores for pain', 'Likert scale scores']","[{'cui': 'C4319614', 'cui_str': '63'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021488', 'cui_str': 'Intra-articular injection'}, {'cui': 'C0037009', 'cui_str': 'Joint structure of shoulder region'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}]","[{'cui': 'C0059079', 'cui_str': 'Eutectic Mixture of Local Anesthetics'}, {'cui': 'C1154182', 'cui_str': 'Spray dose form'}, {'cui': 'C0700385', 'cui_str': 'Cream'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0040464', 'cui_str': 'Topical anesthetic'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0021488', 'cui_str': 'Intra-articular injection'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C1096717', 'cui_str': 'Pain during injection'}, {'cui': 'C0451267', 'cui_str': 'Likert scale'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0558295', 'cui_str': 'Preferences'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",63.0,0.716197,"The spray group showed significantly better Likert scale scores than the placebo group for participant satisfaction (P = 0.003) and preference for repeated use (P < 0.001). ","[{'ForeName': 'Young-Eun', 'Initials': 'YE', 'LastName': 'Moon', 'Affiliation': ""Department of Anesthesiology and Pain Medicine (Moon), Catholic University Seoul St. Mary's Hospital, Seoul, Korea.""}, {'ForeName': 'Sang-Hyun', 'Initials': 'SH', 'LastName': 'Kim', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, College of Medicine, Soonchunhyang University Hospital, Bucheon, Korea. Electronic address: sanghyunkim71@gmail.com.'}, {'ForeName': 'Hyun', 'Initials': 'H', 'LastName': 'Seok', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, College of Medicine, Soonchunhyang University Hospital, Bucheon, Korea.'}, {'ForeName': 'Seung Yeol', 'Initials': 'SY', 'LastName': 'Lee', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, College of Medicine, Soonchunhyang University Hospital, Bucheon, Korea.'}]",Archives of physical medicine and rehabilitation,['10.1016/j.apmr.2020.04.021'] 1922,32446245,"Me, myself, bye: regional alterations in glutamate and the experience of ego dissolution with psilocybin.","There is growing interest in the therapeutic utility of psychedelic substances, like psilocybin, for disorders characterized by distortions of the self-experience, like depression. Accumulating preclinical evidence emphasizes the role of the glutamate system in the acute action of the drug on brain and behavior; however this has never been tested in humans. Following a double-blind, placebo-controlled, parallel group design, we utilized an ultra-high field multimodal brain imaging approach and demonstrated that psilocybin (0.17 mg/kg) induced region-dependent alterations in glutamate, which predicted distortions in the subjective experience of one's self (ego dissolution). Whereas higher levels of medial prefrontal cortical glutamate were associated with negatively experienced ego dissolution, lower levels in hippocampal glutamate were associated with positively experienced ego dissolution. Such findings provide further insights into the underlying neurobiological mechanisms of the psychedelic, as well as the baseline, state. Importantly, they may also provide a neurochemical basis for therapeutic effects as witnessed in ongoing clinical trials.",2020,"There is growing interest in the therapeutic utility of psychedelic substances, like psilocybin, for disorders characterized by distortions of the self-experience, like depression.",[],"['psilocybin', 'placebo']","['medial prefrontal cortical glutamate', 'hippocampal glutamate']",[],"[{'cui': 'C0033850', 'cui_str': 'Psilocybine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205098', 'cui_str': 'Medial'}, {'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C0017789', 'cui_str': 'Glutamates'}, {'cui': 'C0019564', 'cui_str': 'Hippocampal structure'}]",,0.0862072,"There is growing interest in the therapeutic utility of psychedelic substances, like psilocybin, for disorders characterized by distortions of the self-experience, like depression.","[{'ForeName': 'N L', 'Initials': 'NL', 'LastName': 'Mason', 'Affiliation': 'Department of Neuropsychology and Psychopharmacology, Faculty of Psychology and Neuroscience, Maastricht University, P.O. Box 616, 6200 MD, Maastricht, the Netherlands. natasha.mason@maastrichtuniversity.nl.'}, {'ForeName': 'K P C', 'Initials': 'KPC', 'LastName': 'Kuypers', 'Affiliation': 'Department of Neuropsychology and Psychopharmacology, Faculty of Psychology and Neuroscience, Maastricht University, P.O. Box 616, 6200 MD, Maastricht, the Netherlands.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Müller', 'Affiliation': 'Department of Neuropsychology and Psychopharmacology, Faculty of Psychology and Neuroscience, Maastricht University, P.O. Box 616, 6200 MD, Maastricht, the Netherlands.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Reckweg', 'Affiliation': 'Department of Neuropsychology and Psychopharmacology, Faculty of Psychology and Neuroscience, Maastricht University, P.O. Box 616, 6200 MD, Maastricht, the Netherlands.'}, {'ForeName': 'D H Y', 'Initials': 'DHY', 'LastName': 'Tse', 'Affiliation': 'Department of Neuropsychology and Psychopharmacology, Faculty of Psychology and Neuroscience, Maastricht University, P.O. Box 616, 6200 MD, Maastricht, the Netherlands.'}, {'ForeName': 'S W', 'Initials': 'SW', 'LastName': 'Toennes', 'Affiliation': 'Institute of Legal Medicine, University of Frankfurt, Kennedyallee 104, D-60596, Frankfurt/Main, Germany.'}, {'ForeName': 'N R P W', 'Initials': 'NRPW', 'LastName': 'Hutten', 'Affiliation': 'Department of Neuropsychology and Psychopharmacology, Faculty of Psychology and Neuroscience, Maastricht University, P.O. Box 616, 6200 MD, Maastricht, the Netherlands.'}, {'ForeName': 'J F A', 'Initials': 'JFA', 'LastName': 'Jansen', 'Affiliation': 'Department of Radiology and Nuclear Medicine, Maastricht University Medical Center+ (MUMC+), Maastricht, the Netherlands.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Stiers', 'Affiliation': 'Department of Neuropsychology and Psychopharmacology, Faculty of Psychology and Neuroscience, Maastricht University, P.O. Box 616, 6200 MD, Maastricht, the Netherlands.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Feilding', 'Affiliation': 'The Beckley Foundation, Beckley Park, Oxford, OX3 9SY, UK.'}, {'ForeName': 'J G', 'Initials': 'JG', 'LastName': 'Ramaekers', 'Affiliation': 'Department of Neuropsychology and Psychopharmacology, Faculty of Psychology and Neuroscience, Maastricht University, P.O. Box 616, 6200 MD, Maastricht, the Netherlands. j.ramaekers@maastrichtuniversity.nl.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-020-0718-8'] 1923,32580074,Impact of electrical cardioversion on quality of life for patients with symptomatic persistent atrial fibrillation: Is there a treatment expectation effect?,"It is assumed that electrical cardioversion (ECV) improves the quality of life (QoL) of patients with atrial fibrillation (AF) by restoring sinus rhythm (SR). OBJECTIVE We examined the effect of ECV and rhythm status on QoL of patients with symptomatic persistent AF in a randomized controlled trial. METHOD The elective cardioversion for prevention of symptomatic atrial fibrillation trial examined the efficacy of dronedarone around the time of ECV in maintaining SR. Quality of life was measured with the University of Toronto Atrial Fibrillation Severity Scale. The primary outcome was the change in AF symptom severity (∆AFSS) score over 6 months (0-35 points, with higher scores reflecting worse QoL and a minimal clinically important difference defined as ∆AFSS ≥3 points). Multivariable linear regression was performed to identify factors associated with changes in QoL. RESULTS We included 148 patients with complete AFSS scores at baseline and 6 months. Over 6 months, QoL improved irrespective of rhythm status (ΔAFSS scores for patients who (i) maintained SR; (ii) had AF relapse after successful ECV; and (iii) had unsuccessful ECV were -6.8 ± 6.4 points, -4.1 ± 6.2 points, and -4.0 ± 5.8 points respectively, P < .01 for all subgroups). After adjustment of baseline covariates, maintenance of SR was associated with QoL improvement (ΔAFSS: -3.8 points, 95% CI: -6.0 to -1.6 points, P < .01). CONCLUSIONS Maintenance of SR was associated with clinically relevant improvement in patients' QoL at 6 months. Patients with AF recurrence had a small but still relevant improvement in their QoL, potentially due to factors other than sinus rhythm.",2020,"Over 6 months, QoL improved irrespective of rhythm status (ΔAFSS scores for patients who (i) maintained SR; (ii) had AF relapse after successful ECV; and (iii) had unsuccessful ECV were -6.8 ± 6.4 points, -4.1 ± 6.2 points, and -4.0 ± 5.8 points respectively, P < .01 for all subgroups).","['Patients with AF recurrence', 'patients with symptomatic persistent atrial fibrillation', '148 patients with complete AFSS scores at baseline and 6 months', 'patients with symptomatic persistent AF', 'patients with atrial fibrillation (AF) by restoring sinus rhythm (SR']","['electrical cardioversion', 'dronedarone', 'ECV', 'electrical cardioversion (ECV']","['quality of life', 'University of Toronto Atrial Fibrillation Severity Scale', 'quality of life (QoL', 'change in AF symptom severity (∆AFSS) score', 'Quality of life', 'AF relapse', 'unsuccessful ECV', 'QoL improved irrespective of rhythm status (ΔAFSS scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C2585653', 'cui_str': 'Persistent atrial fibrillation'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0232201', 'cui_str': 'Sinus rhythm'}]","[{'cui': 'C0013778', 'cui_str': 'Cardioversion'}, {'cui': 'C0766326', 'cui_str': 'dronedarone'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C1272705', 'cui_str': 'Unsuccessful'}, {'cui': 'C0013778', 'cui_str': 'Cardioversion'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0449438', 'cui_str': 'Status'}]",148.0,0.042951,"Over 6 months, QoL improved irrespective of rhythm status (ΔAFSS scores for patients who (i) maintained SR; (ii) had AF relapse after successful ECV; and (iii) had unsuccessful ECV were -6.8 ± 6.4 points, -4.1 ± 6.2 points, and -4.0 ± 5.8 points respectively, P < .01 for all subgroups).","[{'ForeName': 'Andrew C T', 'Initials': 'ACT', 'LastName': 'Ha', 'Affiliation': 'Peter Munk Cardiac Center, University Health Network, Toronto, Ontario, Canada; Department of Medicine, University of Toronto, Toronto, Ontario, Canada. Electronic address: andrew.ha@uhn.ca.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Stewart', 'Affiliation': 'Sanofi, Montreal, Quebec, Canada.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Klein', 'Affiliation': 'Arrhythmia Service, University Hospital, Western University, London Health Sciences Centre, London, Ontario, Canada.'}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Roy', 'Affiliation': 'Montreal Heart Institute, Université de Montréal, Montreal, Quebec, Canada.'}, {'ForeName': 'Stuart', 'Initials': 'S', 'LastName': 'Connolly', 'Affiliation': 'Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, Ontario, Canada.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Koren', 'Affiliation': 'Sanofi US, Bridgewater, NJ, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Dorian', 'Affiliation': ""Department of Medicine, University of Toronto, Toronto, Ontario, Canada; St. Michael's Hospital, Unity Health Toronto, Toronto, Ontario, Canada.""}]",American heart journal,['10.1016/j.ahj.2020.05.004'] 1924,32446881,Possible differential benefits of edetate disodium in post-myocardial infarction patients with diabetes treated with different hypoglycemic strategies in the Trial to Assess Chelation Therapy (TACT).,"BACKGROUND The NIH-funded Trial to Assess Chelation Therapy (TACT) randomized 1708 stable patients age ≥50 who were ≥6 months post myocardial infarction to 40 infusions of an edetate disodium-based regimen or placebo. In 633 patients with diabetes, edetate disodium significantly reduced the primary composite endpoint of mortality, recurrent myocardial infarction, stroke, coronary revascularization, or hospitalization for angina (hazard ratio [HR] 0.59, 95% confidence interval [CI] 0.44-0.79, p < 0.001). The principal secondary endpoint of a composite of cardiovascular death, myocardial infarction, or stroke was also reduced (HR 0.60, 95% CI 0.39-0.91, p = 0.017). It is unknown if the treatment effect differs by diabetes therapy. METHODS We grouped the subset of 633 patients with diabetes according to glucose-lowering therapy at time of randomization. The log-rank test was used to compare active therapy versus placebo. All treatment comparisons were performed using 2-sided significance tests at the significance level of 0.05 and were as randomized. Relative risks were expressed as HR with associated 95% CI, calculated using the Cox proportional hazards model. RESULTS There were 162 (25.7%) patients treated with insulin; 301 (47.5%) with oral hypoglycemics only; and 170 (26.8%) receiving no pharmacologic treatment for diabetes. Patients on insulin reached the primary endpoint more frequently than patients on no pharmacologic treatment [61 (38%) vs 49 (29%) (HR 1.56, 95% CI 1.07-2.27, p = 0.022)] or oral hypoglycemics [61 (38%) vs 87 (29%) (HR 1.46, 1.05-2.03, p = 0.024)]. The primary endpoint occurred less frequently with edetate disodium based therapy versus placebo in patients on insulin [19 (26%) vs 42 (48%) (HR 0.42, 95% CI 0.25-0.74, log-rank p = 0.002)], marginally in patients on oral hypoglycemics [38 (25%) vs 49 (34%) (HR 0.66, 95% CI 0.43-1.01, log-rank p = 0.041)], and no significant difference in patients not treated with a pharmacologic therapy [23 (25%) vs 26 (34%) (HR 0.69, 95% CI 0.39-1.20, log-rank p = 0.225)]. The interaction between randomized intravenous treatment and type of diabetes therapy was not statistically significant (p = 0.203). CONCLUSIONS Edetate disodium treatment in stable, post-myocardial infarction patients with diabetes suggests that patients on insulin therapy at baseline may accrue the greatest benefit. CLINICAL TRIAL REGISTRATION clinicaltrials.gov identifier: http://clinicaltrials.gov/ct2/show/NCT00044213?term=TACT&rank=7 identifier Trial to Assess Chelation Therapy (TACT), NCT00044213.",2020,Patients on insulin reached the primary endpoint more frequently than patients on no pharmacologic treatment [61 (38%) vs 49 (29%),"['633 patients with diabetes according to glucose-lowering therapy at time of randomization', 'post-myocardial infarction patients with diabetes treated with different hypoglycemic strategies in the Trial to Assess Chelation Therapy (TACT', '1708 stable patients age ≥50 who were ≥6\u202fmonths post myocardial infarction to 40 infusions of an', '633 patients with diabetes']","['edetate disodium', 'placebo', 'Chelation Therapy (TACT', 'edetate disodium-based regimen or placebo', 'disodium']","['oral hypoglycemics', 'primary composite endpoint of mortality, recurrent myocardial infarction, stroke, coronary revascularization, or hospitalization for angina', 'composite of cardiovascular death, myocardial infarction, or stroke']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0020616', 'cui_str': 'Hypoglycemic agent'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0007975', 'cui_str': 'Chelation therapy'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}]","[{'cui': 'C0012695', 'cui_str': 'sodium edetate'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0007975', 'cui_str': 'Chelation therapy'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0020616', 'cui_str': 'Hypoglycemic agent'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0877341', 'cui_str': 'Coronary revascularisation'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0002962', 'cui_str': 'Angina pectoris'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",1708.0,0.261821,Patients on insulin reached the primary endpoint more frequently than patients on no pharmacologic treatment [61 (38%) vs 49 (29%),"[{'ForeName': 'Esteban', 'Initials': 'E', 'LastName': 'Escolar', 'Affiliation': 'Columbia University Division of Cardiology at Mount Sinai Medical Center, Miami, FL, United States of America.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Ujueta', 'Affiliation': 'Columbia University Division of Cardiology at Mount Sinai Medical Center, Miami, FL, United States of America.'}, {'ForeName': 'Hwasoon', 'Initials': 'H', 'LastName': 'Kim', 'Affiliation': 'Duke Clinical Research Institute, Duke University Medical Center, Durham, NC, United States of America; Duke University, Durham, NC, United States of America.'}, {'ForeName': 'Daniel B', 'Initials': 'DB', 'LastName': 'Mark', 'Affiliation': 'Duke Clinical Research Institute, Duke University Medical Center, Durham, NC, United States of America; Duke University, Durham, NC, United States of America.'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Boineau', 'Affiliation': 'National Heart, Lung, and Blood Institute, Bethesda, MD, United States of America.'}, {'ForeName': 'Richard L', 'Initials': 'RL', 'LastName': 'Nahin', 'Affiliation': 'National Heart, Lung, and Blood Institute, Bethesda, MD, United States of America.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Goertz', 'Affiliation': 'Duke Department of Orthopaedic Surgery, Duke University, Durham, NC, United States of America.'}, {'ForeName': 'Kerry L', 'Initials': 'KL', 'LastName': 'Lee', 'Affiliation': 'Duke Clinical Research Institute, Duke University Medical Center, Durham, NC, United States of America; Duke University, Durham, NC, United States of America.'}, {'ForeName': 'Kevin J', 'Initials': 'KJ', 'LastName': 'Anstrom', 'Affiliation': 'Duke Clinical Research Institute, Duke University Medical Center, Durham, NC, United States of America; Duke University, Durham, NC, United States of America.'}, {'ForeName': 'Gervasio A', 'Initials': 'GA', 'LastName': 'Lamas', 'Affiliation': 'Columbia University Division of Cardiology at Mount Sinai Medical Center, Miami, FL, United States of America. Electronic address: gervasio.lamas@msmc.com.'}]",Journal of diabetes and its complications,['10.1016/j.jdiacomp.2020.107616'] 1925,32452588,"A Phase II, Single-Arm, Open-Label, Bayesian Adaptive Efficacy and Safety Study of PBI-05204 in Patients with Stage IV Metastatic Pancreatic Adenocarcinoma.","LESSONS LEARNED This trial evaluating a novel plant extract, PBI-05204, did not meet its primary endpoint of overall survival but did show signals of efficacy in heavily pretreated mPDA. PBI-05204 was generally well tolerated, with the most common side effects related to treatment being vomiting (23.7%), nausea (18.4%), decreased appetite (18.4%), and diarrhea (15.8%). Additional trials are needed to explore the role of PBI-05204 in cancer treatment. BACKGROUND Survival for metastatic pancreatic ductal adenocarcinoma (mPDA) is dismal, and novel agents are needed. PBI-05204 is a modified supercritical carbon dioxide extract of Nerium oleander leaves. Oleandrin, the extract's major cytotoxic component, is a cardiac glycoside that has demonstrated antitumor activity in various tumor cell lines with a mechanism involving inhibition of Akt phosphorylation and through downregulation of mTOR. METHODS A phase II, single-arm, open-label study to determine the efficacy of PBI-05204 in patients with refractory mPDA therapy was conducted. The primary endpoint was overall survival (OS), with the hypothesis that 50% of patients would be alive at 4.5 months. Secondary objectives included safety, progression-free survival (PFS), and overall response rate. Patients received oral PBI-05204 daily until progressive disease (PD), unacceptable toxicity, or patient withdrawal. Radiographic response was assessed every two cycles. RESULTS Forty-two patients were enrolled, and 38 were analyzed. Ten patients were alive at 4.5 months (26.3%) with a median PFS of 56 days. One objective response (2.6%) was observed for 162 days. Grade ≥ 3 treatment-emergent adverse events occurred in 63.2% of patients with the most common being fatigue, vomiting, nausea, decreased appetite, and diarrhea. CONCLUSION PBI-05204 did not meet its primary endpoint for OS in this study. Recent preclinical data indicate a role for PBI-05204 against glioblastoma multiforme when combined with chemotherapy and radiotherapy. A randomized phase II trial is currently being designed.",2020,"3 treatment-emergent adverse events occurred in 63.2% of patients with the most common being fatigue, vomiting, nausea, decreased appetite, and diarrhea. ","['patients with refractory mPDA therapy was conducted', 'metastatic pancreatic ductal adenocarcinoma (mPDA', 'Forty-two patients were enrolled, and 38 were analyzed', 'Patients with Stage IV Metastatic Pancreatic Adenocarcinoma']","['PBI-05204', 'chemotherapy and radiotherapy', 'Oleandrin']","['diarrhea', 'fatigue, vomiting, nausea, decreased appetite, and diarrhea', 'overall survival', 'Radiographic response', 'vomiting', 'Grade ≥', 'safety, progression-free survival (PFS), and overall response rate', 'adverse events', 'nausea', 'overall survival (OS', 'decreased appetite']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C1335302', 'cui_str': 'Ductal adenocarcinoma of pancreas'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C4319566', 'cui_str': '42'}, {'cui': 'C0441772', 'cui_str': 'Stage level 4'}, {'cui': 'C0861727', 'cui_str': 'Pancreatic adenocarcinoma metastatic'}]","[{'cui': 'C2987707', 'cui_str': 'PBI-05204'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0069397', 'cui_str': 'Oleandrin'}]","[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0232462', 'cui_str': 'Decrease in appetite'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",10.0,0.0807327,"3 treatment-emergent adverse events occurred in 63.2% of patients with the most common being fatigue, vomiting, nausea, decreased appetite, and diarrhea. ","[{'ForeName': 'Marc T', 'Initials': 'MT', 'LastName': 'Roth', 'Affiliation': 'Vanderbilt-Ingram Cancer Center, Nashville, Tennessee, USA.'}, {'ForeName': 'Dana Backlund', 'Initials': 'DB', 'LastName': 'Cardin', 'Affiliation': 'Vanderbilt-Ingram Cancer Center, Nashville, Tennessee, USA.'}, {'ForeName': 'Erkut Hasan', 'Initials': 'EH', 'LastName': 'Borazanci', 'Affiliation': 'HonorHealth Research Institute, Scottsdale, Arizona, USA.'}, {'ForeName': 'Margaux', 'Initials': 'M', 'LastName': 'Steinbach', 'Affiliation': 'HonorHealth Research Institute, Scottsdale, Arizona, USA.'}, {'ForeName': 'Vincent J', 'Initials': 'VJ', 'LastName': 'Picozzi', 'Affiliation': 'Virginia Mason Hospital and Medical Center, Seattle, Washington, USA.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Rosemury', 'Affiliation': 'AdventHealth Tampa, Tampa, Florida, USA.'}, {'ForeName': 'Raymond Couric', 'Initials': 'RC', 'LastName': 'Wadlow', 'Affiliation': 'Virginia Cancer Specialists, Fairfax, Virginia, USA.'}, {'ForeName': 'Robert A', 'Initials': 'RA', 'LastName': 'Newman', 'Affiliation': 'MD Anderson Cancer Center, Houston, Texas, USA.'}, {'ForeName': 'Jordan', 'Initials': 'J', 'LastName': 'Berlin', 'Affiliation': 'Vanderbilt-Ingram Cancer Center, Nashville, Tennessee, USA.'}]",The oncologist,['10.1634/theoncologist.2020-0440'] 1926,32453393,"Supplementation with vitamin D or ω-3 fatty acids in adolescent girls and young women with endometriosis (SAGE): a double-blind, randomized, placebo-controlled trial.","BACKGROUND Adolescents with endometriosis are a particularly underserved population who struggle with chronic pain. Despite widespread use, there are no published trials examining the individual effects of vitamin D and omega-3 (n-3) fatty acid supplementation on endometriosis-associated pain in adolescents. OBJECTIVES We aimed to determine whether supplementation with vitamin D or ω-3 fatty acids remediates pain, changes frequency of pain medication usage, or affects quality of life in young women with endometriosis. METHODS Women (aged 12-25 y) with surgically confirmed endometriosis and pelvic pain enrolled in a double-blind, randomized, placebo-controlled trial. The primary outcome was pain measured by the visual analog scale (VAS). Secondary outcomes were quality of life, pain catastrophizing, and pain medication usage. Participants were randomly assigned to receive 2000 IU vitamin D3, 1000 mg fish oil, or placebo daily for 6 mo. RESULTS A total of 147 women were screened and 69 were randomly assigned as follows: 27 to vitamin D3; 20 to fish oil; and 22 to placebo. Participants in the vitamin D arm experienced significant improvement in VAS pain [mean (95% CI) worst pain in the past month, from baseline to 6 mo: 7.0 (6.2, 7.8) to 5.5 (4.2, 6.8), P = 0.02]; however, an improvement of nearly identical magnitude was observed in the placebo arm [6.0 (5.1, 6.9) to 4.4 (3.0, 5.8), P = 0.07]. A more modest improvement was observed in the fish oil arm [5.9 (4.8, 7.0) to 5.2 (3.7, 6.8), P = 0.39]. Neither of the intervention arms were statistically different from placebo. CONCLUSIONS In young women with endometriosis, supplementation with vitamin D led to significant changes in pelvic pain; however, these were similar in magnitude to placebo. Supplementation with fish oil resulted in about half of the VAS pain reduction of the other 2 arms. Studies are needed to better define the physiology underlying the observed reduction in pain score in the placebo arm that persisted across 6 mo.This trial was registered at clinicaltrials.gov as NCT02387931.",2020,"In young women with endometriosis, supplementation with vitamin D led to significant changes in pelvic pain; however, these were similar in magnitude to placebo.","['young women with endometriosis', 'adolescent girls and young women with endometriosis (SAGE', 'A total of 147 women were screened and 69 were randomly assigned as follows: 27 to', 'Women (aged 12-25 y) with surgically confirmed endometriosis and pelvic pain enrolled', 'young women with endometriosis, supplementation with', 'Adolescents with endometriosis are a particularly underserved population who struggle with chronic pain', 'endometriosis-associated pain in adolescents']","['vitamin D or ω-3 fatty acids', 'vitamin D3; 20 to fish oil', '2000 IU vitamin D3, 1000 mg fish oil, or placebo', 'placebo', 'vitamin D', 'vitamin D and omega-3 (n-3) fatty acid supplementation']","['quality of life', 'quality of life, pain catastrophizing, and pain medication usage', 'pain measured by the visual analog scale (VAS', 'pelvic pain', 'VAS pain reduction', 'pain', 'VAS pain', 'pain score']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0014175', 'cui_str': 'Endometriosis'}, {'cui': 'C0001588', 'cui_str': 'Adolescents, Female'}, {'cui': 'C1122976', 'cui_str': 'Sage'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0030794', 'cui_str': 'Pain in pelvis'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C1278569', 'cui_str': 'WAS A'}, {'cui': 'C0872319', 'cui_str': 'Patients, Underserved'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]","[{'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0016157', 'cui_str': 'Fish Oils'}, {'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0015684', 'cui_str': 'Fatty acid'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C3178745', 'cui_str': 'Pain Catastrophizing'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0457083', 'cui_str': 'Usage'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0030794', 'cui_str': 'Pain in pelvis'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}]",147.0,0.819757,"In young women with endometriosis, supplementation with vitamin D led to significant changes in pelvic pain; however, these were similar in magnitude to placebo.","[{'ForeName': 'James L', 'Initials': 'JL', 'LastName': 'Nodler', 'Affiliation': 'Department of Obstetrics and Gynecology, Colorado Center for Reproductive Medicine-Houston, Houston, TX, USA.'}, {'ForeName': 'Amy D', 'Initials': 'AD', 'LastName': 'DiVasta', 'Affiliation': ""Boston Center for Endometriosis, Boston Children's Hospital and Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Allison F', 'Initials': 'AF', 'LastName': 'Vitonis', 'Affiliation': ""Department of Obstetrics, Gynecology, and Reproductive Biology, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Karevicius', 'Affiliation': ""Boston Center for Endometriosis, Boston Children's Hospital and Brigham and Women's Hospital, Boston, MA, USA.""}, {'ForeName': 'Maggie', 'Initials': 'M', 'LastName': 'Malsch', 'Affiliation': ""Institutional Centers for Clinical and Translational Research, Boston Children's Hospital, Boston, MA, USA.""}, {'ForeName': 'Vishnudas', 'Initials': 'V', 'LastName': 'Sarda', 'Affiliation': ""Division of Adolescent and Young Adult Medicine, Department of Medicine, Boston Children's Hospital and Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Ayotunde', 'Initials': 'A', 'LastName': 'Fadayomi', 'Affiliation': ""Department of Obstetrics, Gynecology, and Reproductive Biology, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Holly R', 'Initials': 'HR', 'LastName': 'Harris', 'Affiliation': 'Program in Epidemiology, Division of Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Stacey A', 'Initials': 'SA', 'LastName': 'Missmer', 'Affiliation': ""Boston Center for Endometriosis, Boston Children's Hospital and Brigham and Women's Hospital, Boston, MA, USA.""}]",The American journal of clinical nutrition,['10.1093/ajcn/nqaa096'] 1927,32451659,Early sonographic evaluation of the placenta in cases with IUGR: a pilot study.,"PURPOSE The objective of this study was to evaluate the feasibility and value of measuring early placental echogenicity to predict fetal intrauterine growth restriction (IUGR). METHODS This is a single center, retrospective cohort study. Early ultrasound examination (6 + o to 8 + 6 weeks of gestation in singleton pregnancies) was used to measure placental dimensions and placental echogenicity. A ratio between placental echogenicity and myometrial echogenicity (PE/ME-ratio) was calculated for each patient. Study population was assigned to either the IUGR group or the control group based on clinical data. RESULTS 184 eligible pregnancies were analysed. 49 patients were included in our study. Of those, 9 (18.37%) cases were affected by IUGR and 40 (81.63%) were controls. Measuring the placental echogenicity was feasible in all cases. IUGR neonates had a significant lower placental echogenicity (1.20 (± 0.24) vs. 1.64 (± 0.60), p = 0.033), but no significant differences in the other placental outcomes were observed. CONCLUSION Our results showed that measuring placental echogenicity is feasible in the early first trimester and demonstrated a significantly lower placental echogenicity in fetuses with subsequent IUGR. Further prospective studies are needed to validate those results.",2020,"IUGR neonates had a significant lower placental echogenicity (1.20 (± 0.24) vs. 1.64 (± 0.60), p = 0.033), but no significant differences in the other placental outcomes were observed. ","['184 eligible pregnancies', 'cases with IUGR', '49 patients were included in our study']","['fetal intrauterine growth restriction (IUGR', 'IUGR']","['placental echogenicity', 'placental echogenicity and myometrial echogenicity (PE/ME-ratio', 'feasibility and value of measuring early placental echogenicity', 'placental outcomes']","[{'cui': 'C4517616', 'cui_str': '184'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0015934', 'cui_str': 'Fetal growth restriction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0015965', 'cui_str': 'Fetuses'}, {'cui': 'C0015934', 'cui_str': 'Fetal growth restriction'}]","[{'cui': 'C0032043', 'cui_str': 'Placental structure'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",49.0,0.0319917,"IUGR neonates had a significant lower placental echogenicity (1.20 (± 0.24) vs. 1.64 (± 0.60), p = 0.033), but no significant differences in the other placental outcomes were observed. ","[{'ForeName': 'Adeline', 'Initials': 'A', 'LastName': 'Walter', 'Affiliation': 'Department of Obstetrics and Prenatal Medicine, University Hospital Bonn, Venusberg-Campus 1, 53127, Bonn, Germany.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Böckenhoff', 'Affiliation': 'Department of Obstetrics and Prenatal Medicine, University Hospital Bonn, Venusberg-Campus 1, 53127, Bonn, Germany.'}, {'ForeName': 'Annegret', 'Initials': 'A', 'LastName': 'Geipel', 'Affiliation': 'Department of Obstetrics and Prenatal Medicine, University Hospital Bonn, Venusberg-Campus 1, 53127, Bonn, Germany.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Gembruch', 'Affiliation': 'Department of Obstetrics and Prenatal Medicine, University Hospital Bonn, Venusberg-Campus 1, 53127, Bonn, Germany.'}, {'ForeName': 'Alexander C', 'Initials': 'AC', 'LastName': 'Engels', 'Affiliation': 'Department of Obstetrics and Prenatal Medicine, University Hospital Bonn, Venusberg-Campus 1, 53127, Bonn, Germany. alexander.engels@outlook.com.'}]",Archives of gynecology and obstetrics,['10.1007/s00404-020-05601-7'] 1928,32451660,Ovarian stimulation after dehydroepiandrosterone supplementation in poor ovarian reserve: a randomized clinical trial.,"OBJECTIVE This study aimed at improving fertility rates among infertile women with poor ovarian reserve. METHODS This was a randomized clinical trial conducted in the outpatient clinic of a tertiary hospital. We recruited infertile women with poor ovarian reserve. The study population was divided into 2 groups, each of 25 participants. Both had induction of ovulation for three consecutive cycles. Study group took DHEA supplementation 25 mg/8 h for two consecutive cycles before induction of ovulation. Both groups were compared for outcomes of induction. Baseline ovarian reserve tests and antral follicle count (AFC) were done for both groups before induction of ovulation. The study group repeated these baseline tests after DHEA treatment to compare ovarian reserve before and after DHEA supplementation. Outcome measures were the number of mature follicles at the time of ovulation, the number of gonadotrophin ampoules needed for induction of ovulation, the duration of ovarian stimulation, E2 level at the day of HCG injection. RESULTS The study group baseline investigations after DHEA treatment showed a statistically significant improvement compared to the control group. The outcomes of induction of ovulation in the study group showed a statistically better response than the control group. CONCLUSION DHEA may help many poor responders so better considered for poor responder patients. TRIAL REGISTRATION NUMBER PACTR201911829230395.",2020,"The outcomes of induction of ovulation in the study group showed a statistically better response than the control group. ","['poor ovarian reserve', 'outpatient clinic of a tertiary hospital', 'infertile women with poor ovarian reserve']","['DHEA supplementation', 'dehydroepiandrosterone supplementation']","['Ovarian stimulation', 'Baseline ovarian reserve tests and antral follicle count (AFC', 'induction of ovulation', 'fertility rates', 'number of mature follicles at the time of ovulation, the number of gonadotrophin ampoules needed for induction of ovulation, the duration of ovarian stimulation, E2 level at the day of HCG injection']","[{'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C3850153', 'cui_str': 'Ovarian Reserve'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0021359', 'cui_str': 'Sterility'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0011185', 'cui_str': 'prasterone'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0949385', 'cui_str': 'Ovarian Stimulation'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C3850153', 'cui_str': 'Ovarian Reserve'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C3273281', 'cui_str': 'Antral follicle count'}, {'cui': 'C0029967', 'cui_str': 'Ovulation induction'}, {'cui': 'C0015912', 'cui_str': 'Fertility Rate'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0600225', 'cui_str': 'Vesicular ovarian follicle structure'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0029965', 'cui_str': 'Ovulation'}, {'cui': 'C0018061', 'cui_str': 'Gonadotropin'}, {'cui': 'C0179031', 'cui_str': 'Ampule'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1141639', 'cui_str': 'Human chorionic gonadotropin'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}]",,0.167646,"The outcomes of induction of ovulation in the study group showed a statistically better response than the control group. ","[{'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Elprince', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Suez Canal University, Round Road, Ismailia, 41111, Egypt. prince.ma939@yahoo.com.'}, {'ForeName': 'Eman A', 'Initials': 'EA', 'LastName': 'Kishk', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Suez Canal University, Round Road, Ismailia, 41111, Egypt.'}, {'ForeName': 'Ola M', 'Initials': 'OM', 'LastName': 'Metawie', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Suez Canal University, Round Road, Ismailia, 41111, Egypt.'}, {'ForeName': 'Magda M', 'Initials': 'MM', 'LastName': 'Albiely', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, Suez Canal University, Round Road, Ismailia, 41111, Egypt.'}]",Archives of gynecology and obstetrics,['10.1007/s00404-020-05603-5'] 1929,32459423,Elagolix Treatment for Up to 12 Months in Women With Heavy Menstrual Bleeding and Uterine Leiomyomas.,"OBJECTIVE To investigate the safety and efficacy of elagolix, an oral gonadotropin-releasing hormone antagonist, with hormonal add-back therapy for up to 12 months in women with heavy menstrual bleeding associated with uterine leiomyomas. METHODS Elaris UF-EXTEND was a phase 3 extension study that evaluated an additional 6 months (up to 12 months total) of elagolix 300 mg twice daily with hormonal add-back therapy (estradiol 1 mg and norethindrone acetate 0.5 mg once daily) in women who completed an initial 6 months of the same treatment in one of two preceding phase 3 studies. The primary endpoint was the percentage of women with both less than 80 mL menstrual blood loss during final month and a 50% or greater reduction in menstrual blood loss from baseline to final month. Safety evaluations included adverse events and bone mineral density changes. The planned sample size of UF-EXTEND was based on estimated rollover and discontinuation rates in the two preceding studies. RESULTS From September 2016 to March 2019, 433 women were enrolled in UF-EXTEND. Of these women, 218 received up to 12 months of elagolix with add-back therapy; the mean±SD age of this group was 42.4±5.4 years and 67.3% were black. The percentage of women who met the primary endpoint in this elagolix with add-back group was 87.9% (95% CI [83.4-92.3]). The most frequently reported adverse events with up to 12 months of elagolix plus add-back therapy were hot flush (6.9%), night sweats (3.2%), headache (5.5%), and nausea (4.1%). Mean percent decreases in bone mineral density from baseline to extension month 6 were significantly less with elagolix plus add-back therapy than with elagolix alone {between-group difference in lumbar spine: -3.3 (95% CI [-4.1 to -2.5])}. CONCLUSION Up to 12 months of elagolix with add-back therapy provided sustained reduction in menstrual blood loss in women with uterine leiomyomas, with the addition of add-back therapy attenuating the hypoestrogenic effects of elagolix alone. No new or unexpected safety concerns were associated with an additional 6 months of elagolix with addback therapy. CLINICAL TRIAL REGISTRATION ClinicalTrials.gov, NCT02925494. FUNDING SOURCE AbbVie Inc funded this study.",2020,Mean percent decreases in bone mineral density from baseline to extension month 6 were significantly less with elagolix plus add-back therapy than with elagolix alone {between-group difference in lumbar spine: -3.3,"['Women With Heavy Menstrual Bleeding and Uterine Leiomyomas', 'From September 2016 to March 2019, 433 women were enrolled in UF-EXTEND', 'women with heavy menstrual bleeding associated with uterine leiomyomas', 'women with uterine leiomyomas']","['elagolix with add-back therapy', 'elagolix 300 mg twice daily with hormonal add-back therapy (estradiol 1 mg and norethindrone acetate', 'oral gonadotropin-releasing hormone antagonist, with hormonal add-back therapy', 'elagolix', 'Elagolix']","['headache', 'bone mineral density', 'adverse events and bone mineral density changes', 'menstrual blood loss', 'percentage of women with both less than 80 mL menstrual blood loss', 'adverse events', 'night sweats', 'nausea']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025323', 'cui_str': 'Menorrhagia'}, {'cui': 'C0042133', 'cui_str': 'Leiomyoma'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}]","[{'cui': 'C2714632', 'cui_str': 'elagolix'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0458083', 'cui_str': 'Hormonal'}, {'cui': 'C0985841', 'cui_str': 'Estradiol 1 MG'}, {'cui': 'C0068980', 'cui_str': 'Norethindrone acetate'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C1268855', 'cui_str': 'Gonadotropin releasing hormone receptor antagonist-containing product'}]","[{'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0694689', 'cui_str': 'Menstrual blood'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0028081', 'cui_str': 'Night sweats'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}]",433.0,0.171702,Mean percent decreases in bone mineral density from baseline to extension month 6 were significantly less with elagolix plus add-back therapy than with elagolix alone {between-group difference in lumbar spine: -3.3,"[{'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'Simon', 'Affiliation': 'George Washington University, IntimMedicine Specialists, Washington, DC; University of Illinois at Chicago, Chicago, Illinois; Eastern Virginia Medical School, Norfolk, Virginia; Perleman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania; Cleveland Clinic, Cleveland, Ohio; University of Texas Southwestern Medical Center, Dallas, Texas; Attia Medical, San Diego, California; Northwestern University, Chicago, Illinois; Ochsner Health System, New Orleans, Louisiana; University of Texas Health Science Center at Houston, Houston, Texas; Columbia University, New York, New York; AbbVie Inc, North Chicago, Illinois; SUNY Downstate Health Science University, Brooklyn, New York; Mercy Health, Cincinnati, Ohio; and Thomas Jefferson University, Philadelphia, Pennsylvania.'}, {'ForeName': 'Ayman', 'Initials': 'A', 'LastName': 'Al-Hendy', 'Affiliation': ''}, {'ForeName': 'David F', 'Initials': 'DF', 'LastName': 'Archer', 'Affiliation': ''}, {'ForeName': 'Kurt T', 'Initials': 'KT', 'LastName': 'Barnhart', 'Affiliation': ''}, {'ForeName': 'Linda D', 'Initials': 'LD', 'LastName': 'Bradley', 'Affiliation': ''}, {'ForeName': 'Bruce R', 'Initials': 'BR', 'LastName': 'Carr', 'Affiliation': ''}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Dayspring', 'Affiliation': ''}, {'ForeName': 'Eve C', 'Initials': 'EC', 'LastName': 'Feinberg', 'Affiliation': ''}, {'ForeName': 'Veronica', 'Initials': 'V', 'LastName': 'Gillispie', 'Affiliation': ''}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Hurtado', 'Affiliation': ''}, {'ForeName': 'JinHee', 'Initials': 'J', 'LastName': 'Kim', 'Affiliation': ''}, {'ForeName': 'Ran', 'Initials': 'R', 'LastName': 'Liu', 'Affiliation': ''}, {'ForeName': 'Charlotte D', 'Initials': 'CD', 'LastName': 'Owens', 'Affiliation': ''}, {'ForeName': 'Ozgul', 'Initials': 'O', 'LastName': 'Muneyyirci-Delale', 'Affiliation': ''}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Nelson B', 'Initials': 'NB', 'LastName': 'Watts', 'Affiliation': ''}, {'ForeName': 'William D', 'Initials': 'WD', 'LastName': 'Schlaff', 'Affiliation': ''}]",Obstetrics and gynecology,['10.1097/AOG.0000000000003869'] 1930,32454356,Benefit-cost analysis of Promoting First Relationships®: Implications of victim benefits assumptions for return on investment.,"BACKGROUND Child abuse and neglect (CAN) cost United States society $136 billion to $428 billion annually. Preventive interventions that reduce CAN may improve people's lives and generate economic benefits to society, but their magnitude is likely to vary greatly with assumptions about victim costs avoided through intervention. OBJECTIVE We examined the implications of different assumptions about avoided victim costs in a benefit-cost analysis of Promoting First Relationships® (PFR), a 10-session attachment and strengths-based home visiting intervention. PARTICIPANTS AND SETTING Participants were 247 child protection-involved but intact families in Washington State randomized to receive PFR (n = 124) or resource and referral (n = 123). METHODS We monetized intervention effects on out-of-home placements and implicit effects on CAN and calculated net present values under three scenarios: (1) benefits from avoided system costs, (2) additional benefits from avoided tangible victim costs, and (3) additional benefits from avoided tangible and intangible quality-of-life victim costs. For scenarios 2 and 3, we varied the CAN effect size and estimated the effect size at which PFR was reliably cost beneficial. RESULTS PFR's societal net benefit ranged from $1 (scenario 1) to $5514 - $25,562 (scenario 2) and $7004 - $32,072 (scenario 3) (2014 USD). In scenarios 2 and 3, PFR was reliably cost beneficial at a CAN effect size of approximately -0.25. CONCLUSIONS PFR is cost beneficial assuming tangible victim costs are avoided by PFR. Research into the long-term health and economic consequences of reducing CAN in at-risk populations would contribute to comprehensive, accurate benefits models.",2020,"In scenarios 2 and 3, PFR was reliably cost beneficial at a CAN effect size of approximately -0.25. ",['Participants were 247 child protection-involved but intact families in Washington State randomized to receive PFR (n = 124) or resource and referral (n = 123'],['Promoting First Relationships®'],[],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0205266', 'cui_str': 'Intact'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0043038', 'cui_str': 'Washington'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0459868', 'cui_str': 'First relationship'}, {'cui': 'C4517553', 'cui_str': '124'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}]","[{'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0459868', 'cui_str': 'First relationship'}]",[],,0.0284117,"In scenarios 2 and 3, PFR was reliably cost beneficial at a CAN effect size of approximately -0.25. ","[{'ForeName': 'Margaret R', 'Initials': 'MR', 'LastName': 'Kuklinski', 'Affiliation': 'Social Development Research Group, School of Social Work, University of Washington, 9725 Third Ave. NE, Suite 401, Seattle, WA 98115, United States. Electronic address: mrk63@uw.edu.'}, {'ForeName': 'Monica L', 'Initials': 'ML', 'LastName': 'Oxford', 'Affiliation': 'Department of Child, Family, and Population Health Nursing, School of Nursing, University of Washington, United States. Electronic address: mloxford@uw.edu.'}, {'ForeName': 'Susan J', 'Initials': 'SJ', 'LastName': 'Spieker', 'Affiliation': 'Department of Child, Family, and Population Health Nursing, School of Nursing, University of Washington, United States. Electronic address: spieker@uw.edu.'}, {'ForeName': 'Mary Jane', 'Initials': 'MJ', 'LastName': 'Lohr', 'Affiliation': 'Department of Child, Family, and Population Health Nursing, School of Nursing, University of Washington, United States. Electronic address: mjlohr@uw.edu.'}, {'ForeName': 'Charles B', 'Initials': 'CB', 'LastName': 'Fleming', 'Affiliation': 'Center for The Study of Health and Risk Behavior, Department of Psychiatry, University of Washington, United States. Electronic address: cnbflem@uw.edu.'}]",Child abuse & neglect,['10.1016/j.chiabu.2020.104515'] 1931,32457075,Cholinergic Modulation of Binocular Vision.,"The endogenous neurotransmitter acetylcholine (ACh) is known to affect the excitatory/inhibitory (E/I) balance of primate visual cortex, enhancing feedforward thalamocortical gain while suppressing corticocortical synapses. Recent advances in the study of the human visual system suggest that ACh is a likely component underlying interocular interactions. However, our understanding of its precise role in binocular processes is currently lacking. Here we use binocular rivalry as a probe of interocular dynamics to determine ACh's effects, via the acetylcholinesterase inhibitor (AChEI) donepezil, on the binocular visual system. A total of 23 subjects (13 male) completed two crossover experimental sessions where binocular rivalry measurements were obtained before and after taking either donepezil (5 mg) or a placebo (lactose) pill. We report that enhanced cholinergic potentiation attenuates perceptual suppression during binocular rivalry, reducing the overall rate of interocular competition while enhancing the visibility of superimposition mixed percepts. Considering recent evidence that perceptual suppression during binocular rivalry is causally modulated by the inhibitory neurotransmitter GABA, our results suggest that cholinergic activity counteracts the effect of GABA with regards to interocular dynamics and may modulate the inhibitory drive within the visual cortex. SIGNIFICANCE STATEMENT Our research demonstrates that the cholinergic system is implicated in modulating binocular interactions in the human visual cortex. Potentiating the transmission of acetylcholine (ACh) via the cholinergic drug donepezil reduces the extent to which the eyes compete for perceptual dominance when presented two separate, incongruent images.",2020,"Increasing the potentiation of acetylcholine via the cholinergic drug donepezil reduces the extent to which the eyes compete for perceptual dominance when presented two separate, incongruent images.",['23 Subjects (13 male'],"['placebo (lactose) pill', 'acetylcholinesterase inhibitor (AChEI) donepezil ', 'acetylcholine', 'donepezil']",['binocular rivalry measurements'],"[{'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}, {'cui': 'C0001046', 'cui_str': 'Acetylcholinesterase inhibitor'}, {'cui': 'C0527316', 'cui_str': 'donepezil'}, {'cui': 'C0001041', 'cui_str': 'Acetylcholine'}]","[{'cui': 'C2594855', 'cui_str': 'Binoculars'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}]",23.0,0.0594407,"Increasing the potentiation of acetylcholine via the cholinergic drug donepezil reduces the extent to which the eyes compete for perceptual dominance when presented two separate, incongruent images.","[{'ForeName': 'Yasha', 'Initials': 'Y', 'LastName': 'Sheynin', 'Affiliation': 'McGill Vision Research, McGill University, Montréal, Quebec H3G 1A4, Canada.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Rosa-Neto', 'Affiliation': 'Douglas Mental Health University Institute, McGill University, Montréal, Quebec H4H 1R3, Canada.'}, {'ForeName': 'Robert F', 'Initials': 'RF', 'LastName': 'Hess', 'Affiliation': 'McGill Vision Research, McGill University, Montréal, Quebec H3G 1A4, Canada robert.hess@mcgill.ca elvire.vaucher@umontreal.ca.'}, {'ForeName': 'Elvire', 'Initials': 'E', 'LastName': 'Vaucher', 'Affiliation': ""Laboratoire de Neurobiologie de la Cognition Visuelle, École d'Optométrie, Université de Montréal, Montréal, Quebec H3T 1P1, Canada robert.hess@mcgill.ca elvire.vaucher@umontreal.ca.""}]",The Journal of neuroscience : the official journal of the Society for Neuroscience,['10.1523/JNEUROSCI.2484-19.2020'] 1932,32458393,Correction to: Conservative Sinusectomy vs. excision and primary off-midline closure for pilonidal disease: a randomized controlled trial.,"The original version of this article, unfortunately, contained an error. The given names and family names of the authors were interchanged and are now presented correctly. The original article has been corrected.].",2020,"The original version of this article, unfortunately, contained an error.",['pilonidal disease'],['Conservative Sinusectomy vs. excision and primary off-midline closure'],[],"[{'cui': 'C2317114', 'cui_str': 'Pilonidal disease'}]","[{'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}]",[],,0.0503036,"The original version of this article, unfortunately, contained an error.","[{'ForeName': 'Sotirios Georgios', 'Initials': 'SG', 'LastName': 'Popeskou', 'Affiliation': 'Department of Visceral Surgery and Transplantation, Geneva University Hospitals, Geneva, Switzerland. salvator10@yahoo.com.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Pravini', 'Affiliation': 'Depatment of Surgery, Regional Hospital of Lugano, Lugano, Switzerland.'}, {'ForeName': 'Sofoklis', 'Initials': 'S', 'LastName': 'Panteleimonitis', 'Affiliation': 'School of Health Sciences and social work, University of Portsmouth, Portsmouth, UK.'}, {'ForeName': 'Antoniacopo', 'Initials': 'A', 'LastName': 'Ferrario di Tor Vajana', 'Affiliation': 'Department of Surgery, Regional Hospital of Bellinzona, Bellinzona, Switzerland.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Vanoni', 'Affiliation': 'Department of Visceral Surgery, Lausanne University Hospital, Lausanne, Switzerland.'}, {'ForeName': 'Mike', 'Initials': 'M', 'LastName': 'Schmalzbauer', 'Affiliation': 'Depatment of Surgery, Regional Hospital of Lugano, Lugano, Switzerland.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Posabella', 'Affiliation': 'Department of Surgery, Standort Unispital Clarunis, Universitäres Bauchzentrum Basel, Basel, Switzerland.'}, {'ForeName': 'Dimitri', 'Initials': 'D', 'LastName': 'Christoforidis', 'Affiliation': 'Depatment of Surgery, Regional Hospital of Lugano, Lugano, Switzerland. dimitri.christoforidis@eoc.ch.'}]",International journal of colorectal disease,['10.1007/s00384-020-03620-z'] 1933,32453667,Biomechanical Functional Elbow Restoration of Acute Ulnar Collateral Ligament Tears: The Role of Internal Bracing on Gap Formation and Repair Stabilization.,"BACKGROUND Biomechanical studies have compared augmented primary repair with internal bracing versus reconstruction techniques of the anterior ulnar collateral ligament (aUCL) in the elbow. However, aUCL repair alone has not been compared with augmented repair or reconstruction techniques. HYPOTHESIS Internal bracing of aUCL repair provides improved time-zero stabilization in terms of gap formation, torsional stiffness, and residual torque compared with both repair alone and the modified docking technique, with enhanced valgus stability restoration to that of the native ligament. STUDY DESIGN Controlled laboratory study. METHODS We randomized 8 matched pairs of cadaveric elbows to undergo either augmented aUCL repair or a modified docking technique through use of the palmaris longus tendon. Valgus laxity testing was consecutively performed at 90° of flexion on the intact, torn, and repaired conditions as well as the previously assigned techniques. First, intact elbows were loaded up to 10 N·m valgus torque to evaluate time-zero ligament rotations at valgus moments of 2.5, 5.0, 7.5, and 10 N·m. Rotation controlled cycling was performed (total 1000 cycles) for each surgical condition. Gap formation, stiffness, and residual torque were analyzed. Finally, these elbows and 8 additional intact elbows underwent torque to failure testing (30 deg/min). RESULTS Repair alone revealed low torsional resistance and gapping, similar to the torn state. The augmented repair technique showed significantly higher torsional stiffness ( P < .001) and residual torque ( P < .001) compared with all other conditions and restored native function. Although reconstruction revealed similar initial stiffness and residual torque compared with an intact ligament, a steady decrease of torsional resistance led to a completely loose state at higher valgus rotations. Analysis of covariance between all groups showed significantly less gap formation for augmented repair ( P < .001). The native failure load and stiffness were significantly higher and were similar to those of augmented repair ( P = .766). CONCLUSION Internal bracing of aUCL repair restored valgus stability to the native state with statistically improved torsional resistance, loading capability, and gap formation compared with reconstruction, especially at the upper load range of native aUCL function in the elbow. CLINICAL RELEVANCE We found that aUCL repair with an internal brace effectively improves time-zero mechanical characteristics and may provide stabilized healing with accelerated and reliable recovery without the need for a tendon graft.",2020,The augmented repair technique showed significantly higher torsional stiffness ( P < .001) and residual torque ( P < .001) compared with all other conditions and restored native function.,['Acute Ulnar Collateral Ligament Tears'],"['cadaveric elbows to undergo either augmented aUCL repair or a modified docking technique through use of the palmaris longus tendon', 'primary repair with internal bracing versus reconstruction techniques of the anterior ulnar collateral ligament (aUCL']","['torsional stiffness', 'low torsional resistance', 'time-zero mechanical characteristics', 'native failure load and stiffness', 'Biomechanical Functional Elbow Restoration', 'residual torque', 'torsional resistance', 'torsional resistance, loading capability, and gap formation', 'initial stiffness and residual torque', 'Gap formation, stiffness, and residual torque']","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C1261052', 'cui_str': 'Structure of collateral carpal ulnar ligament'}, {'cui': 'C0039409', 'cui_str': 'Tears'}]","[{'cui': 'C0013769', 'cui_str': 'Elbow region structure'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C1261052', 'cui_str': 'Structure of collateral carpal ulnar ligament'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0442632', 'cui_str': 'Dock - marine'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0448547', 'cui_str': 'Structure of tendon of palmaris longus'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C1828220', 'cui_str': 'Application of brace'}, {'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}]","[{'cui': 'C0450425', 'cui_str': 'Torsional'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0919414', 'cui_str': '0'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0079891', 'cui_str': 'Indigenous Population'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0013769', 'cui_str': 'Elbow region structure'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0318082', 'cui_str': 'Ruminococcus torques'}, {'cui': 'C0061928', 'cui_str': 'GTPase-Activating Protein'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0205265', 'cui_str': 'Initial'}]",8.0,0.0337054,The augmented repair technique showed significantly higher torsional stiffness ( P < .001) and residual torque ( P < .001) compared with all other conditions and restored native function.,"[{'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Bachmaier', 'Affiliation': 'Arthrex Department of Orthopedic Research, Munich, Germany.'}, {'ForeName': 'Coen A', 'Initials': 'CA', 'LastName': 'Wijdicks', 'Affiliation': 'Arthrex Department of Orthopedic Research, Munich, Germany.'}, {'ForeName': 'Nikhil N', 'Initials': 'NN', 'LastName': 'Verma', 'Affiliation': 'Rush University Medical Center, Chicago, Illinois, USA.'}, {'ForeName': 'Laurence D', 'Initials': 'LD', 'LastName': 'Higgins', 'Affiliation': 'Arthrex Department of Orthopedic Research, Munich, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Greiner', 'Affiliation': 'Sporthopaedicum, Regensburg, Germany.'}]",The American journal of sports medicine,['10.1177/0363546520921174'] 1934,32464351,Efficacy and safety of 5-Hydroxytryptophan on levodopa-induced motor complications in Parkinson's disease: A preliminary finding.,"BACKGROUND AND PURPOSE Several studies have indicated that altered serotonergic neurotransmission may contribute to the motor features commonly associated with Parkinson's disease (PD) drug treatment such as levodopa-induced dyskinesias (LIDs). 5-Hydroxytryptophan (5-HTP) is the immediate precursor of serotonin. We have recently demonstrated that 5-HTP produces significant antidyskinetic effects in a rat model of PD. To date, there has been inconsistent research on the use of 5-HTP in PD. The purpose of this study was to compare the effects of 5-HTP versus placebo on levodopa-induced motor complications in PD patients. MATERIAL AND METHODS A single-center, randomized, double-blind placebo-controlled cross-over study was performed. A total of 12 PD patients were diagnosed with LIDs and motor fluctuactions and subsequently were randomized to intervention; 11 subjects completed the entire 16-week protocol. Patients received placebo or 50 mg of 5-HTP daily in a cross-over design over a period of 4 weeks. For the assessment of efficacy on the motor functions and motor complications, the UPDRS (parts III and IV), Unified Dyskinesia Rating Scale (UDysRS), Wearing-Off Questionnaire (WOQ-19) and the self-reported 24-h home dyskinesia diaries were obtained at baseline and weeks 4, 8, 12 and 16 (T-end). RESULTS Repeated measures analysis revealed a significant improvement of LIDs during the 50 mg 5-HTP treatment as assessed by the UDysRS and UPDRS-IV scores. CONCLUSIONS This study provides preliminary evidence of clinical benefit of 5-HTP against LIDs in PD. Larger studies with a longer treatment duration and a wider range of doses are warranted to corroborate these findings.",2020,"RESULTS Repeated measures analysis revealed a significant improvement of LIDs during the 50 mg 5-HTP treatment as assessed by the UDysRS and UPDRS-IV scores. ","['PD patients', ""Parkinson's disease"", '12 PD patients were diagnosed with LIDs and motor fluctuactions and subsequently were randomized to intervention; 11 subjects completed the entire 16-week protocol']","['5-Hydroxytryptophan', '5-HTP versus placebo', '5-Hydroxytryptophan (5-HTP', '5-HTP', 'placebo or 50\xa0mg of 5-HTP', '5-HTP against LIDs', 'placebo']","['UDysRS and UPDRS-IV scores', 'Efficacy and safety', 'motor functions and motor complications, the UPDRS (parts III and IV), Unified Dyskinesia Rating Scale (UDysRS), Wearing-Off Questionnaire (WOQ-19) and the self-reported 24-h home dyskinesia diaries', 'LIDs']","[{'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0023570', 'cui_str': 'Levodopa'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0013384', 'cui_str': 'Dyskinesia'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439751', 'cui_str': 'Entire'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0000578', 'cui_str': '5-Hydroxytryptophan'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0023570', 'cui_str': 'Levodopa'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0013384', 'cui_str': 'Dyskinesia'}]","[{'cui': 'C0013384', 'cui_str': 'Dyskinesia'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C3639721', 'cui_str': 'UPDRS Panel'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0234130', 'cui_str': 'Motor function'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0449719', 'cui_str': 'Part'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C0023570', 'cui_str': 'Levodopa'}, {'cui': 'C0205263', 'cui_str': 'Induced'}]",,0.222511,"RESULTS Repeated measures analysis revealed a significant improvement of LIDs during the 50 mg 5-HTP treatment as assessed by the UDysRS and UPDRS-IV scores. ","[{'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Meloni', 'Affiliation': 'Department of Medical Sciences and Public Health, University of Cagliari, Cagliari, Italy. Electronic address: mario.meloni@hotmail.it.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Puligheddu', 'Affiliation': 'Sleep Disorders Center, Department of Medical Sciences and Public Health, University of Cagliari, Cagliari, Italy; Department of Medical Sciences and Public Health, Neurology Unit, University of Cagliari and AOU Cagliari, Monserrato, Cagliari, Italy.'}, {'ForeName': 'Fabrizio', 'Initials': 'F', 'LastName': 'Sanna', 'Affiliation': 'Department of Biomedical Sciences, University of Cagliari, Cagliari, Italy.'}, {'ForeName': 'Antonino', 'Initials': 'A', 'LastName': 'Cannas', 'Affiliation': 'Department of Medical Sciences and Public Health, Neurology Unit, University of Cagliari and AOU Cagliari, Monserrato, Cagliari, Italy.'}, {'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Farris', 'Affiliation': 'Department of Medical Sciences and Public Health, University of Cagliari, Cagliari, Italy.'}, {'ForeName': 'Elisabetta', 'Initials': 'E', 'LastName': 'Tronci', 'Affiliation': 'Department of Biomedical Sciences, University of Cagliari, Cagliari, Italy.'}, {'ForeName': 'Michela', 'Initials': 'M', 'LastName': 'Figorilli', 'Affiliation': 'Sleep Disorders Center, Department of Medical Sciences and Public Health, University of Cagliari, Cagliari, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Defazio', 'Affiliation': 'Department of Medical Sciences and Public Health, Neurology Unit, University of Cagliari and AOU Cagliari, Monserrato, Cagliari, Italy.'}, {'ForeName': 'Manolo', 'Initials': 'M', 'LastName': 'Carta', 'Affiliation': 'Department of Biomedical Sciences, University of Cagliari, Cagliari, Italy.'}]",Journal of the neurological sciences,['10.1016/j.jns.2020.116869'] 1935,32472075,Two nights of recovery sleep restores hippocampal connectivity but not episodic memory after total sleep deprivation.,"Sleep deprivation significantly impairs a range of cognitive and brain function, particularly episodic memory and the underlying hippocampal function. However, it remains controversial whether one or two nights of recovery sleep following sleep deprivation fully restores brain and cognitive function. In this study, we used functional magnetic resonance imaging (fMRI) and examined the effects of two consecutive nights (20-hour time-in-bed) of recovery sleep on resting-state hippocampal connectivity and episodic memory deficits following one night of total sleep deprivation (TSD) in 39 healthy adults in a controlled in-laboratory protocol. TSD significantly reduced memory performance in a scene recognition task, impaired hippocampal connectivity to multiple prefrontal and default mode network regions, and disrupted the relationships between memory performance and hippocampal connectivity. Following TSD, two nights of recovery sleep restored hippocampal connectivity to baseline levels, but did not fully restore memory performance nor its associations with hippocampal connectivity. These findings suggest that more than two nights of recovery sleep are needed to fully restore memory function and hippocampal-memory associations after one night of total sleep loss.",2020,"TSD significantly reduced memory performance in a scene recognition task, impaired hippocampal connectivity to multiple prefrontal and default mode network regions, and disrupted the relationships between memory performance and hippocampal connectivity.",['39 healthy adults in a controlled in-laboratory protocol'],"['two consecutive nights (20-hour time-in-bed) of recovery sleep', 'total sleep deprivation (TSD', 'TSD', 'functional magnetic resonance imaging (fMRI']","['hippocampal connectivity to multiple prefrontal and default mode network regions', 'Sleep deprivation', 'memory performance']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0004914', 'cui_str': 'Bedding'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0037316', 'cui_str': 'Sleep deprivation'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}]","[{'cui': 'C0019564', 'cui_str': 'Hippocampal structure'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0037316', 'cui_str': 'Sleep deprivation'}, {'cui': 'C1285654', 'cui_str': 'Memory performance'}]",39.0,0.0326211,"TSD significantly reduced memory performance in a scene recognition task, impaired hippocampal connectivity to multiple prefrontal and default mode network regions, and disrupted the relationships between memory performance and hippocampal connectivity.","[{'ForeName': 'Ya', 'Initials': 'Y', 'LastName': 'Chai', 'Affiliation': 'Department of Psychology, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Zhuo', 'Initials': 'Z', 'LastName': 'Fang', 'Affiliation': 'Laboratory of Applied Brain and Cognitive Sciences, School of Business and Management, Shanghai International Studies University, Shanghai, China.'}, {'ForeName': 'Fan Nils', 'Initials': 'FN', 'LastName': 'Yang', 'Affiliation': 'Department of Psychology, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Sihua', 'Initials': 'S', 'LastName': 'Xu', 'Affiliation': 'Laboratory of Applied Brain and Cognitive Sciences, School of Business and Management, Shanghai International Studies University, Shanghai, China.'}, {'ForeName': 'Yao', 'Initials': 'Y', 'LastName': 'Deng', 'Affiliation': 'Laboratory of Applied Brain and Cognitive Sciences, School of Business and Management, Shanghai International Studies University, Shanghai, China.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Raine', 'Affiliation': 'Center for Functional Neuroimaging, Department of Neurology, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Jieqiong', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Center for Functional Neuroimaging, Department of Neurology, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Meichen', 'Initials': 'M', 'LastName': 'Yu', 'Affiliation': 'Center for Neuromodulation in Depression and Stress, Department of Psychiatry, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Mathias', 'Initials': 'M', 'LastName': 'Basner', 'Affiliation': 'Division of Sleep and Chronobiology, Department of Psychiatry, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Namni', 'Initials': 'N', 'LastName': 'Goel', 'Affiliation': 'Division of Sleep and Chronobiology, Department of Psychiatry, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Junghoon J', 'Initials': 'JJ', 'LastName': 'Kim', 'Affiliation': 'Department of Molecular, Cellular, and Biomedical Sciences, CUNY School of Medicine, The City College of New York, New York, NY, USA.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Wolk', 'Affiliation': 'Center for Functional Neuroimaging, Department of Neurology, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Detre', 'Affiliation': 'Center for Functional Neuroimaging, Department of Neurology, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'David F', 'Initials': 'DF', 'LastName': 'Dinges', 'Affiliation': 'Division of Sleep and Chronobiology, Department of Psychiatry, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Hengyi', 'Initials': 'H', 'LastName': 'Rao', 'Affiliation': 'Center for Functional Neuroimaging, Department of Neurology, University of Pennsylvania, Philadelphia, PA, USA. hengyi@pennmedicine.upenn.edu.'}]",Scientific reports,['10.1038/s41598-020-65086-x'] 1936,32472611,Novel dose escalation to predict treatment with hydroxyurea (NDEPTH): A randomized controlled trial of a dose-prediction equation to determine maximum tolerated dose of hydroxyurea in pediatric sickle cell disease.,,2020,,['Pediatric Sickle Cell Disease'],"['Hydroxyurea (NDEPTH', 'Hydroxyurea']",[],"[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0002895', 'cui_str': 'Sickling disorder due to hemoglobin S'}]","[{'cui': 'C0020402', 'cui_str': 'hydroxyurea'}]",[],,0.125772,,"[{'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'George', 'Affiliation': ""Department of Pediatrics, Texas Children's Cancer and Hematology Centers, Baylor College of Medicine, Houston, Texas, USA.""}, {'ForeName': 'Bogdan', 'Initials': 'B', 'LastName': 'Dinu', 'Affiliation': ""Department of Pediatrics, Texas Children's Cancer and Hematology Centers, Baylor College of Medicine, Houston, Texas, USA.""}, {'ForeName': 'Norma', 'Initials': 'N', 'LastName': 'Estrada', 'Affiliation': ""Department of Pediatrics, Texas Children's Cancer and Hematology Centers, Baylor College of Medicine, Houston, Texas, USA.""}, {'ForeName': 'Charles G', 'Initials': 'CG', 'LastName': 'Minard', 'Affiliation': 'Institute for Clinical and Translational Research, Baylor College of Medicine, Houston, Texas, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Hurwitz', 'Affiliation': ""Department of Pediatrics, Texas Children's Cancer and Hematology Centers, Baylor College of Medicine, Houston, Texas, USA.""}, {'ForeName': 'Donald H', 'Initials': 'DH', 'LastName': 'Mahoney', 'Affiliation': ""Department of Pediatrics, Texas Children's Cancer and Hematology Centers, Baylor College of Medicine, Houston, Texas, USA.""}, {'ForeName': 'Amber M', 'Initials': 'AM', 'LastName': 'Yates', 'Affiliation': ""Department of Pediatrics, Texas Children's Cancer and Hematology Centers, Baylor College of Medicine, Houston, Texas, USA.""}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Vaughan', 'Affiliation': ""Department of Pediatrics, Texas Children's Cancer and Hematology Centers, Baylor College of Medicine, Houston, Texas, USA.""}, {'ForeName': 'Alaundra', 'Initials': 'A', 'LastName': 'Carmouche', 'Affiliation': ""Department of Pediatrics, Texas Children's Cancer and Hematology Centers, Baylor College of Medicine, Houston, Texas, USA.""}, {'ForeName': 'Gladstone', 'Initials': 'G', 'LastName': 'Airewele', 'Affiliation': ""Department of Pediatrics, Texas Children's Cancer and Hematology Centers, Baylor College of Medicine, Houston, Texas, USA.""}, {'ForeName': 'Susan E', 'Initials': 'SE', 'LastName': 'Kirk', 'Affiliation': ""Department of Pediatrics, Texas Children's Cancer and Hematology Centers, Baylor College of Medicine, Houston, Texas, USA.""}, {'ForeName': 'Titilope', 'Initials': 'T', 'LastName': 'Fasipe', 'Affiliation': ""Department of Pediatrics, Texas Children's Cancer and Hematology Centers, Baylor College of Medicine, Houston, Texas, USA.""}, {'ForeName': 'Precious', 'Initials': 'P', 'LastName': 'Uwaezuoke', 'Affiliation': ""Department of Pediatrics, Texas Children's Cancer and Hematology Centers, Baylor College of Medicine, Houston, Texas, USA.""}, {'ForeName': 'Russell E', 'Initials': 'RE', 'LastName': 'Ware', 'Affiliation': ""Division of Hematology, Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, USA.""}]",American journal of hematology,['10.1002/ajh.25883'] 1937,32469811,Endogenous cortisol-related alterations of right anterior insula functional connectivity under acute stress.,"BACKGROUND Previous studies have suggested that the right anterior insula (rAI) plays a vital role in salience processing and stress-related disorders. In this study, we aimed to investigate the relationship between rAI functional connectivity changes and individual differences in cortisol responses after acute stress, in order to provide insights into psychiatric illness vulnerabilities. METHODS Thirty-five young men were enrolled in a randomized, counterbalanced two-session study, with aversive movie clip combined with electrical shocks as stress stimulation and the neutral movie clip as control stimulation. Resting-state fMRI data was acquired after movie exposure. The rAI was chosen as seed for functional connectivity analysis. We then examined the effect of acute stress on rAI functional connectivity and its association with individuals' cortisol response. RESULTS We found decreased rAI functional connectivity in the fronto-parietal regions, but increased functional connectivity in the visual and somatosensory areas following acute stress. Moreover, stress-induced cortisol response was significantly positively correlated with the rAI functional connectivity in the medial prefrontal cortex, and negatively correlated with the orbital-frontal cortex, lingual gyrus, and middle temporal gyrus. LIMITATIONS Only young Chinese males without any trauma experience were recruited in this study. CONCLUSIONS The results suggested tight link between specific rAI functional connectivity alterations and individual stress reactivity, which may help elucidate the potential neurobiological mechanism underlying vulnerability to stress-related disorders.",2020,"We found decreased rAI functional connectivity in the fronto-parietal regions, but increased functional connectivity in the visual and somatosensory areas following acute stress.","['Only young Chinese males without any trauma experience', 'Thirty-five young men']",['aversive movie clip combined with electrical shocks as stress stimulation and the neutral movie clip as control stimulation'],"['stress-induced cortisol response', 'orbital-frontal cortex, lingual gyrus, and middle temporal gyrus', 'functional connectivity', 'rAI functional connectivity']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C4319605', 'cui_str': '35'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0681495', 'cui_str': 'Movies'}, {'cui': 'C0175722', 'cui_str': 'Clip'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0013781', 'cui_str': 'Exposure to electric current, with passage of current through tissue'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0699036', 'cui_str': 'Orbital'}, {'cui': 'C0016733', 'cui_str': 'Frontal lobe structure'}, {'cui': 'C0152308', 'cui_str': 'Structure of lingual gyrus'}, {'cui': 'C0152310', 'cui_str': 'Structure of middle temporal gyrus'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0441997', 'cui_str': 'Right anterior'}, {'cui': 'C0021640', 'cui_str': 'Insular structure'}]",35.0,0.0233179,"We found decreased rAI functional connectivity in the fronto-parietal regions, but increased functional connectivity in the visual and somatosensory areas following acute stress.","[{'ForeName': 'Yuyang', 'Initials': 'Y', 'LastName': 'Zhu', 'Affiliation': 'Institute of Radiation Medicine, Academy of Military Medical Sciences, Beijing, 100850, China; Institute of Military Cognition and Brain Sciences, Academy of Military Medical Sciences, Beijing, 100850, China.'}, {'ForeName': 'Yituo', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Radiology, Seventh Medical Center of the Chinese PLA General Hospital, Beijing, 100700, China.'}, {'ForeName': 'Zheng', 'Initials': 'Z', 'LastName': 'Yang', 'Affiliation': 'Institute of Military Cognition and Brain Sciences, Academy of Military Medical Sciences, Beijing, 100850, China.'}, {'ForeName': 'Lubin', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Institute of Military Cognition and Brain Sciences, Academy of Military Medical Sciences, Beijing, 100850, China. Electronic address: wanglb@bmi.ac.cn.'}, {'ForeName': 'Xiangjun', 'Initials': 'X', 'LastName': 'Hu', 'Affiliation': 'Institute of Radiation Medicine, Academy of Military Medical Sciences, Beijing, 100850, China. Electronic address: xjhu2003@vip.sina.com.'}]",Journal of affective disorders,['10.1016/j.jad.2020.05.123'] 1938,32469835,"The effectiveness of modified, group-based CBT for dementia worry among Chinese elders.","OBJECTIVES Dementias are highly prevalent among Chinese elders. This study examined the effectiveness of a modified group cognitive behavioral therapy (CBT) on dementia worry among Chinese older adults. METHODS Eighty-two older adults recruited from four elder group homes were randomly assigned to either intervention or control group. The intervention group (n= 44) received eight weekly 60-minute face-to-face CBT, while the control group (n=38) received treatment-as-usual. RESULTS Outcomes indicated that the modified group CBT has significantly reduced dementia worry and culturally biased beliefs about dementia (p<.001). Study findings supported both statistically and clinically significant effect of modified group CBT on dementia worry [g=-1.52, 95% CI (-2.01, -1.03)] and biased beliefs about dementia [g=-.95, 95% CI (-1.40, -.49)]. DISCUSSION The culturally adapted CBT is promising in alleviating worries and anxiety over dementia among Chinese older adults. Future research needs to include larger samples and participants from different regions to replicate findings.",2020,"RESULTS Outcomes indicated that the modified group CBT has significantly reduced dementia worry and culturally biased beliefs about dementia (p<.001).","['Eighty-two older adults recruited from four elder group homes', 'Chinese elders', 'Chinese older adults']","['eight weekly 60-minute face-to-face CBT, while the control group (n=38) received treatment-as-usual', 'modified, group-based CBT', 'modified group cognitive behavioral therapy (CBT']","['dementia worry', 'dementia worry and culturally biased beliefs about dementia']","[{'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0018257', 'cui_str': 'Group Homes'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0331055', 'cui_str': 'Genus Sambucus'}]","[{'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C3853333', 'cui_str': 'Sixty minutes'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0233481', 'cui_str': 'Worried'}, {'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0005346', 'cui_str': 'Biases'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}]",82.0,0.0313174,"RESULTS Outcomes indicated that the modified group CBT has significantly reduced dementia worry and culturally biased beliefs about dementia (p<.001).","[{'ForeName': 'Qiuling', 'Initials': 'Q', 'LastName': 'An', 'Affiliation': 'East China Normal University, School of Social Development, 500 DongChuan Rd., Shanghai, China.'}, {'ForeName': 'Kaipeng', 'Initials': 'K', 'LastName': 'Wang', 'Affiliation': 'University of Denver, Graduate School of Social Work, Denver, CO, USA. Electronic address: Kaipeng.Wang@du.edu.'}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Sun', 'Affiliation': 'Michigan State University, School of Social Work, East Lansing, MI, USA.'}, {'ForeName': 'Anao', 'Initials': 'A', 'LastName': 'Zhang', 'Affiliation': 'University of Michigan, School of Social Work, Ann Arbor, MI, USA.'}]",Journal of affective disorders,['10.1016/j.jad.2020.05.054'] 1939,32469838,"Repeated transcranial direct current stimulation of dorsolateral-prefrontal cortex improves executive functions, cognitive reappraisal emotion regulation, and control over emotional processing in borderline personality disorder: A randomized, sham-controlled, parallel-group study.","BACKGROUND Borderline personality disorder (BPD) is primarily characterized by deficient emotion regulation. Impaired cognitive control over negative emotions is central to emotion dysregulation in BPD. Respective executive dysfunctions are associated with hypoactivation of prefrontal regions, and consecutive alterations of fronto-limbic network functionality. Here, we investigated the effect of increasing activity of the dorsolateral prefrontal cortex (DLPFC) with repeated transcranial direct current stimulation (tDCS) on (1) executive dysfunctions and (2) whether improving cognitive control affects emotion dysregulation and emotional processing in BPD. METHODS Thirty-two patients diagnosed with BPD were randomly assigned to active stimulation (N = 16) or sham stimulation (N = 16) group in a randomized, sham-controlled, parallel-group design. They received 10 sessions of active (2 mA, 20 min, anodal left- cathodal right DLPFC) or sham tDCS over 10 days. Major executive functions, emotion regulation strategies, and emotional processing of the patients were assessed before and immediately after the intervention. RESULTS The active stimulation group showed a significant improvement in major executive function domains. Importantly, cognitive reappraisal strategy of emotion regulation and several factors of emotional processing involved in the control of emotion significantly improved in the active stimulation group after the intervention. Factors related to emotional expression were, however, not affected. LIMITATIONS The single-blind design, absence of follow-up measures, and the intrinsically limited focality of tDCS are limitations of this study. CONCLUSIONS Increasing activity of the DLPFC improves executive functioning in BPD and improves ´cognitive control over negative emotions. Cognitive control interventions could be a potential, symptom-driven therapeutic approach in BPD.",2020,"Respective executive dysfunctions are associated with hypoactivation of prefrontal regions, and consecutive alterations of fronto-limbic network functionality.","['borderline personality disorder', 'Thirty-two patients diagnosed with BPD', 'Borderline personality disorder (BPD']","['10 sessions of active (2\xa0mA, 20\xa0min, anodal left', 'repeated transcranial direct current stimulation (tDCS', 'cathodal right DLPFC) or sham tDCS', 'Cognitive control interventions', 'transcranial direct current stimulation of dorsolateral-prefrontal cortex', 'active stimulation (N\xa0=\xa016) or sham stimulation']","['emotional expression', 'major executive function domains', 'Major executive functions, emotion regulation strategies, and emotional processing', 'executive functions, cognitive reappraisal emotion regulation']","[{'cui': 'C0006012', 'cui_str': 'Borderline personality disorder'}, {'cui': 'C0450357', 'cui_str': '32'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C4019080', 'cui_str': 'Prefrontal Cortex, Dorsolateral'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}]","[{'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}]",32.0,0.096733,"Respective executive dysfunctions are associated with hypoactivation of prefrontal regions, and consecutive alterations of fronto-limbic network functionality.","[{'ForeName': 'Parviz', 'Initials': 'P', 'LastName': 'Molavi', 'Affiliation': 'Department of Psychiatry, Fatemi Hospital, School of Medicine, Ardabil University of Medical Science, Ardabil, Iran.'}, {'ForeName': 'Samaneh', 'Initials': 'S', 'LastName': 'Aziziaram', 'Affiliation': 'Department of Psychology, University of Mohaghegh Ardabili, Ardabil, Iran.'}, {'ForeName': 'Sajjad', 'Initials': 'S', 'LastName': 'Basharpoor', 'Affiliation': 'Department of Psychology, University of Mohaghegh Ardabili, Ardabil, Iran. Electronic address: basharpoor_sajjad@uma.ac.ir.'}, {'ForeName': 'Akbar', 'Initials': 'A', 'LastName': 'Atadokht', 'Affiliation': 'Department of Psychology, University of Mohaghegh Ardabili, Ardabil, Iran.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Nitsche', 'Affiliation': 'Department of Psychology and Neurosciences, Leibniz Research Institute for Working Environment and Human Factors, Dortmund, Germany; University Medical Hospital Bergmannsheil, Department of Neurology, Bochum, Germany.'}, {'ForeName': 'Mohammed Ali', 'Initials': 'MA', 'LastName': 'Salehinejad', 'Affiliation': 'Department of Psychology and Neurosciences, Leibniz Research Institute for Working Environment and Human Factors, Dortmund, Germany; Ruhr-University Bochum, International Graduate School of Neuroscience, Bochum, Germany. Electronic address: salehinejad@ifado.de.'}]",Journal of affective disorders,['10.1016/j.jad.2020.05.007'] 1940,32470574,Pharmacokinetic and bioequivalence study of new S-1 capsule in Chinese cancer patients.,"S-1 is a multicomponent capsule containing tegafur, gimeracil, and oteracil potassium that has shown anticancer activity against numerous tumor types. However, S-1 capsules from different manufacturing companies have shown variations in pharmacokinetics and safety. Therefore, this multicenter, single-dose, randomized-sequence, open-label, two-way, self-crossover study was conducted to evaluate the bioequivalence of a newly developed generic S-1 (New Times Pharmaceutical Co., Ltd., Shandong, China) and the original brand-name S-1 capsule (Taiho Pharmaceutical Co., Ltd., Japan). Furthermore, the safety profiles of both products were compared. A total of 70 patients with 18 types cancer including breast, lung, gastric, and colorectal recruited at 5 hospitals who were randomly and alternatively administered 50 mg of the reference and test S-1 with a 7-day interval. Plasma concentrations of tegafur, 5-chloro-2,4-dihydroxypyridine (CDHP), oteracil potassium, and 5-fluorouracil were detected using liquid chromatography-tandem mass spectrometry (LC-MS/MS). Pharmacokinetic parameters, including maximum drug concentration (C max ), time to achieve C max (T max ), half-life (t 1/2 , area under the concentration-time curve from 0-time t (AUC 0-t ), and AUC from 0-infinity (AUC 0-∞ ) were determined using non-compartmental analysis with DAS2.0 software. Bioequivalence of the reference and test S-1 was evaluated according to 90% confidence intervals (CIs) for ratios of AUC and C max of S-1. Adverse events were evaluated by monitoring symptoms, physical and laboratory examinations, electrocardiogram, and subject interviews. No significant difference was observed in plasma concentrations and pharmacokinetic profiles of tegafur, CDHP, oteracil potassium, or 5-fluorouracil (p > 0.05) among cancer patients treated with the reference or test S-1 formulation. The 90% CIs of C max , AUC 0-t , and AUC 0-∞ ratios were within the 80%-125% limit. The generic S-1 caused eight mild adverse events including liver dysfunction, diarrhea, nausea, fatigue, abnormal blood electrolytes, hyperglycemia, and dermal toxicity. Similarly, 18 mild adverse events were observed including dysarteriotony, diarrhea, nausea, fatigue, fever, hematotoxicity, abnormal blood electrolytes, hyperglycemia, dermal toxicity, and joint pain. There were no differences in the adverse event incidence between the two formulations. In conclusion, the newly developed generic S-1 showed similar pharmacokinetics to those of an original brand-name S-1 in cancer patients, thereby indicating bioequivalence. Furthermore, both treatments were well tolerated, suggesting that the cost-effective generic S-1 should be considered as a feasible option when treating patients.",2020,"No significant difference was observed in plasma concentrations and pharmacokinetic profiles of tegafur, CDHP, oteracil potassium, or 5-fluorouracil (p > 0.05) among cancer patients treated with the reference or test S-1 formulation.","['Chinese cancer patients', '70 patients with 18 types cancer including breast, lung, gastric, and colorectal recruited at 5 hospitals']",['new S-1 capsule'],"['adverse event incidence', 'liver dysfunction, diarrhea, nausea, fatigue, abnormal blood electrolytes, hyperglycemia, and dermal toxicity', 'pharmacokinetics and safety', 'Adverse events', 'Plasma concentrations of tegafur, 5-chloro-2,4-dihydroxypyridine (CDHP), oteracil potassium, and 5-fluorouracil', 'dysarteriotony, diarrhea, nausea, fatigue, fever, hematotoxicity, abnormal blood electrolytes, hyperglycemia, dermal toxicity, and joint pain', 'monitoring symptoms, physical and laboratory examinations, electrocardiogram, and subject interviews', 'maximum drug concentration (C max ), time to achieve C max (T max ), half-life (t 1/2 , area under the concentration-time curve from 0-time t (AUC 0-t ), and AUC from 0-infinity (AUC 0-∞ ', 'plasma concentrations and pharmacokinetic profiles of tegafur, CDHP, oteracil potassium, or 5-fluorouracil']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0038351', 'cui_str': 'Stomach'}, {'cui': 'C0555952', 'cui_str': 'Colorectal'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0879262', 'cui_str': 'S 1 (combination)'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0086565', 'cui_str': 'Abnormal liver function'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0205161', 'cui_str': 'Abnormal'}, {'cui': 'C0853360', 'cui_str': 'Blood electrolytes'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C1522447', 'cui_str': 'Cutaneous route'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0016778', 'cui_str': 'Tegafur'}, {'cui': 'C0535459', 'cui_str': 'Gimeracil'}, {'cui': 'C0393003', 'cui_str': 'potassium oxonate'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0920103', 'cui_str': 'Haematotoxicity'}, {'cui': 'C0003862', 'cui_str': 'Joint pain'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0260877', 'cui_str': 'Laboratory examination'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0018517', 'cui_str': 'Halflife'}, {'cui': 'C0580272', 'cui_str': '1/2'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}]",70.0,0.0538582,"No significant difference was observed in plasma concentrations and pharmacokinetic profiles of tegafur, CDHP, oteracil potassium, or 5-fluorouracil (p > 0.05) among cancer patients treated with the reference or test S-1 formulation.","[{'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Center of New Drug Clinical Trial, Hunan Cancer Hospital and The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Changsha, China.'}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Jiang', 'Affiliation': 'Center of New Drug Clinical Trial, Hunan Cancer Hospital and The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Changsha, China.'}, {'ForeName': 'Jingjing', 'Initials': 'J', 'LastName': 'Qu', 'Affiliation': 'Center of New Drug Clinical Trial, Hunan Cancer Hospital and The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Changsha, China.'}, {'ForeName': 'Qiming', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': 'Department of Internal Medicine, Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital, Zhengzhou, China.'}, {'ForeName': 'Yuxian', 'Initials': 'Y', 'LastName': 'Bai', 'Affiliation': 'Department of Gastrointestinal Oncology, Harbin Medical University Cancer Hospital, Harbin, China.'}, {'ForeName': 'Jianhua', 'Initials': 'J', 'LastName': 'Shi', 'Affiliation': 'Department of Oncology, Linyi Cancer Hospital, Linyi, China.'}, {'ForeName': 'Yehui', 'Initials': 'Y', 'LastName': 'Shi', 'Affiliation': 'Phase I Clinical Trial Department of Tianjin Medical University Cancer Institute and Hospital, Tianjin, China.'}, {'ForeName': 'Xue', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Center of New Drug Clinical Trial, Hunan Cancer Hospital and The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Changsha, China.'}, {'ForeName': 'Nong', 'Initials': 'N', 'LastName': 'Yang', 'Affiliation': 'Center of New Drug Clinical Trial, Hunan Cancer Hospital and The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Changsha, China.'}, {'ForeName': 'Jianfu', 'Initials': 'J', 'LastName': 'Heng', 'Affiliation': 'Center of New Drug Clinical Trial, Hunan Cancer Hospital and The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Changsha, China. Electronic address: hengjianfu@hnca.org.cn.'}, {'ForeName': 'Kunyan', 'Initials': 'K', 'LastName': 'Li', 'Affiliation': 'Center of New Drug Clinical Trial, Hunan Cancer Hospital and The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Changsha, China. Electronic address: lkunyan@163.com.'}]",European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences,['10.1016/j.ejps.2020.105384'] 1941,32471080,"Effectiveness of a Family Intervention to Increase Physical Activity in Disadvantaged Areas-A Healthy Generation, a Controlled Pilot Study.","There are large social inequalities in health. The purpose of this study was to evaluate the effects of a family intervention on physical activity (PA) and sedentary time (ST) in children and their parents. In this controlled pilot study, all 8-9-year-old children from four schools from a socioeconomically disadvantaged area in Sweden were invited and 67 children and 94 parents were included. The intervention was run by a foundation in co-operation with the municipality. The 9-month program included: (1) activity sessions, (2) healthy meals, (3) health information and (4) parental support groups. PA was primary outcome and ST was secondary outcome, measured by accelerometry. In total, 40 of the children (60%) and 45 of the adults (50%) had at least one day of valid accelerometer data at both baseline and follow-up. Significant intervention effects for the whole group were found in total PA ( p = 0.048, mean difference (MD) intervention/control 150 counts per minute) and in vigorous PA ( p = 0.02, MD 8 min/day) during the weekends. There were no differences between groups in the other PA variables or ST. This pilot study shows that it is possible to influence PA in families from a disadvantaged area through a family program.",2020,"Significant intervention effects for the whole group were found in total PA ( p = 0.048, mean difference (MD) intervention/control 150 counts per minute) and in vigorous PA ( p = 0.02, MD 8 min/day) during the weekends.","['all 8-9-year-old children from four schools from a socioeconomically disadvantaged area in Sweden were invited and 67 children and 94 parents were included', 'families from a disadvantaged area through a family program', 'Disadvantaged Areas', 'children and their parents']","['activity sessions, (2) healthy meals, (3) health information and (4) parental support groups', 'family intervention', 'Family Intervention']","['physical activity (PA) and sedentary time (ST', 'total PA']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0012613', 'cui_str': 'Disadvantaged'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0418946', 'cui_str': 'Parental support'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",,0.0240404,"Significant intervention effects for the whole group were found in total PA ( p = 0.048, mean difference (MD) intervention/control 150 counts per minute) and in vigorous PA ( p = 0.02, MD 8 min/day) during the weekends.","[{'ForeName': 'Gisela', 'Initials': 'G', 'LastName': 'Nyberg', 'Affiliation': 'Department of Global Public Health, Karolinska Institutet, 171 77 Stockholm, Sweden.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Andermo', 'Affiliation': 'Department of Global Public Health, Karolinska Institutet, 171 77 Stockholm, Sweden.'}, {'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'Nordenfelt', 'Affiliation': 'The Foundation A Healthy Generation, 118 63 Stockholm, Sweden.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Lidin', 'Affiliation': 'Department of Medicine, Karolinska Institutet, 171 76 Stockholm, Sweden.'}, {'ForeName': 'Mai-Lis', 'Initials': 'ML', 'LastName': 'Hellénius', 'Affiliation': 'Department of Medicine, Karolinska Institutet, 171 76 Stockholm, Sweden.'}]",International journal of environmental research and public health,['10.3390/ijerph17113794'] 1942,32473186,"The effects of GAMotion (a giant exercising board game) on physical capacity, motivation and quality of life among nursing home residents: A pilot interventional study.","BACKGROUND In 2017, our team highlighted promising results of a giant exercising board game on physical activity level and a broader array of physical and psychological outcomes among nursing home residents. However, some improvements of this game were needed to make it more suitable for nursing homes and more challenging in terms of exercises. Therefore, we decided to develop a new version of a giant exercising board game: the GAMotion. OBJECTIVES The primary objective of this pilot study was to assess the impact of the GAMotion on physical capacity among nursing home residents. The secondary aims were to assess the impact of the GAMotion on motivation and quality of life in this population. METHODS A one-month pilot interventional study was performed in two comparable nursing homes. Eleven participants meeting the inclusion criteria took part in the intervention in one nursing home, whereas 10 participants were assigned to the control group in the other institution. The GAMotion required participants to perform strength, flexibility, balance and endurance activities. The assistance provided by an exercising specialist decreased gradually during the intervention in an autonomy-oriented approach based on the self-determination theory. Physical capacity (i.e. fall risk using Tinetti test; dynamic balance using Timed Up and Go test (TUG); physical abilities using SPPB test; grip strength using Jamar dynamometer; isometric lower limb muscle strength using MicroFET2 and quantitative evaluation of walking using Locometrix), motivation (i.e. using Behavioral Regulation in Exercise Questionnaire-2) and quality of life (i.e. using EQ-5D questionnaire) were assessed at baseline and at the end of the intervention. A two-way repeated-measure analysis of variance (ANOVA) was used to assess time*group (intervention vs. control group) effects. All the analyses were adjusted on age, which differed significantly between the 2 groups at baseline. RESULTS During the intervention period, the experimental group displayed a greater improvement in Tinetti score (p < 0.0001), TUG (p = 0.02), SPPB (p < 0.0001), knee extensor isometric strength (p = 0.04), grip strength (p = 0.02), symmetry of steps (p = 0.04), 3 domains of the EQ-5D (i.e. mobility, self-care, usual activities: p < 0.0001) and intrinsic motivation (p = 0.02) compared to the control group. No significant improvement was demonstrated on the other parameters. CONCLUSION These promising results should be interpreted with caution because of certain limitations (e.g. small sample size, no blind assessment). Further investigation is required to confirm and evaluate the long-term effectiveness of the GAMotion in nursing homes.",2020,"During the intervention period, the experimental group displayed a greater improvement in Tinetti score (p < 0.0001), TUG (p = 0.02), SPPB (p < 0.0001), knee extensor isometric strength (p = 0.04), grip strength (p = 0.02), symmetry of steps (p = 0.04), 3 domains of the EQ-5D (i.e. mobility, self-care, usual activities: p < 0.0001) and intrinsic motivation (p = 0.02) compared to the control group.","['nursing home residents', 'Eleven participants meeting the inclusion criteria took part in the intervention in one nursing home, whereas 10 participants were assigned to the control group in the other institution', 'two comparable nursing homes']","['GAMotion', 'GAMotion (a giant exercising board game']","['SPPB', 'TUG', 'intrinsic motivation', 'knee extensor isometric strength', 'motivation and quality of life', 'grip strength', 'physical capacity, motivation and quality of life', 'physical capacity', 'strength, flexibility, balance and endurance activities', 'quality of life (i.e. using EQ-5D questionnaire', 'Tinetti score', 'Physical capacity']","[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0028688', 'cui_str': 'Long term care facility'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}]","[{'cui': 'C0017547', 'cui_str': 'Gigantism'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0392350', 'cui_str': 'Intrinsic motivation'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0429271', 'cui_str': 'Grip strength'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",2.0,0.028377,"During the intervention period, the experimental group displayed a greater improvement in Tinetti score (p < 0.0001), TUG (p = 0.02), SPPB (p < 0.0001), knee extensor isometric strength (p = 0.04), grip strength (p = 0.02), symmetry of steps (p = 0.04), 3 domains of the EQ-5D (i.e. mobility, self-care, usual activities: p < 0.0001) and intrinsic motivation (p = 0.02) compared to the control group.","[{'ForeName': 'Fanny', 'Initials': 'F', 'LastName': 'Buckinx', 'Affiliation': 'WHO Collaborating Center for Public Health aspects of musculo-skeletal health and ageing, Division of Public Health, Epidemiology and Health Economics, University of Liège, Belgium. Electronic address: fanny.buckinx@uliege.be.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Bruyère', 'Affiliation': 'WHO Collaborating Center for Public Health aspects of musculo-skeletal health and ageing, Division of Public Health, Epidemiology and Health Economics, University of Liège, Belgium; Department of Sport and Rehabilitation Sciences, Multidisciplinary Research Unit on Health and Society, University of Liège, Liège, Belgium.'}, {'ForeName': 'Laetitia', 'Initials': 'L', 'LastName': 'Lengelé', 'Affiliation': 'WHO Collaborating Center for Public Health aspects of musculo-skeletal health and ageing, Division of Public Health, Epidemiology and Health Economics, University of Liège, Belgium.'}, {'ForeName': 'Jean-Yves', 'Initials': 'JY', 'LastName': 'Reginster', 'Affiliation': 'WHO Collaborating Center for Public Health aspects of musculo-skeletal health and ageing, Division of Public Health, Epidemiology and Health Economics, University of Liège, Belgium.'}, {'ForeName': 'Quentin', 'Initials': 'Q', 'LastName': 'Marchal', 'Affiliation': 'Department of Sport and Rehabilitation Sciences, Multidisciplinary Research Unit on Health and Society, University of Liège, Liège, Belgium.'}, {'ForeName': 'Paulin', 'Initials': 'P', 'LastName': 'Hurtrez', 'Affiliation': 'Department of Sport and Rehabilitation Sciences, Multidisciplinary Research Unit on Health and Society, University of Liège, Liège, Belgium.'}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Mouton', 'Affiliation': 'Department of Sport and Rehabilitation Sciences, Multidisciplinary Research Unit on Health and Society, University of Liège, Liège, Belgium.'}]",Experimental gerontology,['10.1016/j.exger.2020.110983'] 1943,32477853,Text messaging and lottery incentive to improve colorectal cancer screening outreach at a community health center: A randomized controlled trial.,"Efforts to boost colorectal cancer (CRC) screening rates in underserved populations have been limited by effectiveness and scalability. We evaluate the impact of adding a lottery-based financial incentive to a text messaging program that asks patients to opt-in to receive mailed fecal immunochemical testing (FIT). This is a two-arm pragmatic randomized controlled trial at a community health center in Southwest Philadelphia from April to July 2017. We included CRC screening-eligible patients between ages 50-74 years who had a mobile phone, active health insurance, and at least one visit to the clinic in the past 12 months. Patients received a text message about CRC screening with the opportunity to opt-in to receive mailed FIT. They were randomized 1:1 to the following: (1) text messaging outreach alone (text), or (2) text messaging with lottery for a 1-in-5 chance of winning $100 after FIT completion (text + lottery). The primary outcome was the percentage of patients completing the mailed FIT within 3 months of initial outreach. 281 patients were included in the intent-to-treat analysis. The FIT completion rate was 12.1% (95% CI, 6.7%-17.5%) in the text message arm and 12.1% (95% CI, 6.7%-17.5%) in the lottery arm, with no statistical difference between arms. The majority of post-intervention interview respondents found text messaging to be acceptable and convenient. Opt-in text messaging is a feasible option to promote the uptake of mailed FIT screening, but the addition of a lottery-based incentive did not improve completion rates. Trial Registration: clinicaltrials.gov (NCT03072095).",2020,"The FIT completion rate was 12.1% (95% CI, 6.7%-17.5%) in the text message arm and 12.1% (95% CI, 6.7%-17.5%) in the lottery arm, with no statistical difference between arms.","['community health center in Southwest Philadelphia from April to July 2017', '281 patients were included in the intent-to-treat analysis', 'eligible patients between ages 50-74\xa0years who had a mobile phone, active health insurance, and at least one visit to the clinic in the past 12\xa0months']","['text messaging outreach alone (text), or (2) text messaging with lottery', 'lottery-based financial incentive to a text messaging program', 'Text messaging and lottery incentive to improve colorectal cancer screening outreach', 'CRC screening', 'text message about CRC screening']","['FIT completion rate', 'percentage of patients completing the mailed FIT within 3\xa0months of initial outreach']","[{'cui': 'C0009469', 'cui_str': 'Satellite Centers'}, {'cui': 'C0031525', 'cui_str': 'Philadelphia'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1136360', 'cui_str': 'Car Phone'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0021682', 'cui_str': 'Health Insurance'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C3178908', 'cui_str': 'Texting'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0376243', 'cui_str': 'finances'}, {'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}]","[{'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024492', 'cui_str': 'Mail'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205265', 'cui_str': 'Initial'}]",281.0,0.290046,"The FIT completion rate was 12.1% (95% CI, 6.7%-17.5%) in the text message arm and 12.1% (95% CI, 6.7%-17.5%) in the lottery arm, with no statistical difference between arms.","[{'ForeName': 'Shivan J', 'Initials': 'SJ', 'LastName': 'Mehta', 'Affiliation': 'Department of Medicine, Perelman School of Medicine, University of Pennsylvania, United States.'}, {'ForeName': 'Akinbowale', 'Initials': 'A', 'LastName': 'Oyalowo', 'Affiliation': 'Department of Medicine, Perelman School of Medicine, University of Pennsylvania, United States.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Reitz', 'Affiliation': 'Department of Medicine, Perelman School of Medicine, University of Pennsylvania, United States.'}, {'ForeName': 'Owen', 'Initials': 'O', 'LastName': 'Dean', 'Affiliation': 'Department of Medicine, Perelman School of Medicine, University of Pennsylvania, United States.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'McAuliffe', 'Affiliation': 'Department of Medicine, Perelman School of Medicine, University of Pennsylvania, United States.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Asch', 'Affiliation': 'Department of Medicine, Perelman School of Medicine, University of Pennsylvania, United States.'}, {'ForeName': 'Chyke A', 'Initials': 'CA', 'LastName': 'Doubeni', 'Affiliation': 'Center for Health Equity and Community Engagement Research, Mayo Clinic, United States.'}]",Preventive medicine reports,['10.1016/j.pmedr.2020.101114'] 1944,32478863,A pilot randomised placebo-controlled trial of cannabidiol to reduce severe behavioural problems in children and adolescents with intellectual disability.,"AIMS Severe behavioural problems (SBP) are a major contributor to morbidity in children with intellectual disability (ID). Medications used to treat SBP in ID are associated with a high risk of side effects. Cannabidiol has potential therapeutic effects in SBP. This pilot study aimed to investigate the feasibility of conducting a randomised placebo-controlled trial of cannabidiol to reduce SBP in children with ID. METHODS This is a double-blind, placebo-controlled, two-armed, parallel-design, randomised controlled trial of cannabidiol in children aged 8-16 years with ID and SBP. Participants were randomised 1:1 to receive either 98% cannabidiol in oil (Tilray, Canada) or placebo orally for 8 weeks. The dose was up-titrated over 9 days to 20 mg/kg/day in two divided doses, with a maximum dose of 500 mg twice/day. The feasibility and acceptability of all study components were assessed. RESULTS Eight children were randomised, and all completed the full study protocol. There were no serious adverse events or drop-outs. Protocol adherence for key study components was excellent: study visits 100%, medication adherence 100%, blood tests 92% and questionnaire completion 88%. Parents reported a high degree of acceptability with the study design. All parents reported they would recommend the study to other families with children with similar problems. There was an efficacy signal in favour of active drug. CONCLUSIONS The findings suggest that the study protocol is feasible and acceptable to patients with ID and SBP and their families.",2020,There were no Serious Adverse Events or drop-outs.,"['children and adolescents with intellectual disability', 'children aged 8 - 16 years with ID and SBP', 'children with ID', 'children with Intellectual Disability (ID', 'Eight children']","['cannabidiol', '98% cannabidiol in oil (Tilray, Canada) or placebo', 'placebo']",['severe behavioural problems'],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C3714756', 'cui_str': 'Intellectual disability'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0233514', 'cui_str': 'Abnormal behavior'}]","[{'cui': 'C0006863', 'cui_str': 'Cannabidiol'}, {'cui': 'C0028908', 'cui_str': 'Oil'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0233514', 'cui_str': 'Abnormal behavior'}]",8.0,0.496793,There were no Serious Adverse Events or drop-outs.,"[{'ForeName': 'Daryl', 'Initials': 'D', 'LastName': 'Efron', 'Affiliation': ""Murdoch Children's Research Institute, Parkville, Victoria, Australia.""}, {'ForeName': 'Jeremy L', 'Initials': 'JL', 'LastName': 'Freeman', 'Affiliation': ""Murdoch Children's Research Institute, Parkville, Victoria, Australia.""}, {'ForeName': 'Noel', 'Initials': 'N', 'LastName': 'Cranswick', 'Affiliation': ""Murdoch Children's Research Institute, Parkville, Victoria, Australia.""}, {'ForeName': 'Jonathan M', 'Initials': 'JM', 'LastName': 'Payne', 'Affiliation': ""Murdoch Children's Research Institute, Parkville, Victoria, Australia.""}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Mulraney', 'Affiliation': ""Murdoch Children's Research Institute, Parkville, Victoria, Australia.""}, {'ForeName': 'Chidambaram', 'Initials': 'C', 'LastName': 'Prakash', 'Affiliation': ""Royal Children's Hospital, Parkville, Victoria, Australia.""}, {'ForeName': 'Katherine J', 'Initials': 'KJ', 'LastName': 'Lee', 'Affiliation': ""Murdoch Children's Research Institute, Parkville, Victoria, Australia.""}, {'ForeName': 'Kaitlyn', 'Initials': 'K', 'LastName': 'Taylor', 'Affiliation': ""Murdoch Children's Research Institute, Parkville, Victoria, Australia.""}, {'ForeName': 'Katrina', 'Initials': 'K', 'LastName': 'Williams', 'Affiliation': 'Monash University, Clayton, Victoria, Australia.'}]",British journal of clinical pharmacology,['10.1111/bcp.14399'] 1945,32449678,Arterial stiffness and kidney disease progression in the systolic blood pressure intervention trial
.,"AIMS Arterial stiffness increases with both advancing age and chronic kidney disease (CKD) and may contribute to kidney function decline, but evidence is inconsistent. We hypothesized that greater baseline arterial stiffness (assessed as pulse pressure (PP) and carotid-femoral pulse-wave velocity CFPWV)) was independently associated with kidney disease progression over the follow-up period (3.8 years) in the Systolic Blood Pressure Intervention Trial (SPRINT). MATERIALS AND METHODS 8,815 SPRINT participants were included in the analysis of PP. 592 adults who participated in a SPRINT ancillary study that measured CFPWV were included in subgroup analyses. Cox proportional hazards analysis was used to examine the association between PP and time to kidney disease progression endpoints: (A) incident estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73m 2 in non-CKD participants at baseline; (B) 50% decline in eGFR, initiation of dialysis, or transplant in those with baseline CKD. Mixed model analyses examined the association of baseline PP/CFPWV with follow-up eGFR. RESULTS AND CONCLUSION Mean ± SD age was 68 ± 10 years, baseline PP was 62 ± 14 mmHg, and CFPWV was 10.8 ± 2.7 m/s. In the fully adjusted model, PP ≥ median was associated with an increased hazard of kidney disease progression endpoints (HR: 1.93 (1.43 - 2.61)). The association remained significant in individuals without (2.05 (1.47 - 2.87)) but not with baseline CKD (1.28 (0.55 - 2.65)). In fully adjusted models, higher baseline PP associated with eGFR decline (p < 0.0001 (all, CKD, non-CKD)), but baseline CFPWV did not. Among older adults at high risk for cardiovascular events, baseline PP was associated with kidney disease progression.",2020,The association remained significant in individuals without (2.05 (1.47 - 2.87)) but not with baseline CKD (1.28 (0.55 - 2.65)).,"['8,815 SPRINT participants were included in the analysis of PP', 'SD age was 68\xa0±\xa010 years, baseline PP was 62\xa0±', '592 adults who participated in a SPRINT ancillary study that measured CFPWV were included in subgroup analyses', 'older adults']",[],"['Mean\xa0±', 'Arterial stiffness and kidney disease progression', 'baseline arterial stiffness', 'glomerular filtration rate (eGFR', 'pulse pressure (PP) and carotid-femoral pulse-wave velocity CFPWV', 'hazard of kidney disease progression endpoints', 'eGFR decline', 'kidney disease progression']","[{'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]",[],"[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0599949', 'cui_str': 'Arterial stiffness'}, {'cui': 'C0022658', 'cui_str': 'Kidney disease'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0949236', 'cui_str': 'Pulse Pressure'}, {'cui': 'C5197774', 'cui_str': 'Carotid-Femoral Pulse Wave Velocities'}]",8815.0,0.068225,The association remained significant in individuals without (2.05 (1.47 - 2.87)) but not with baseline CKD (1.28 (0.55 - 2.65)).,"[{'ForeName': 'Kristen L', 'Initials': 'KL', 'LastName': 'Nowak', 'Affiliation': ''}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Chonchol', 'Affiliation': ''}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Jovanovich', 'Affiliation': ''}, {'ForeName': 'Zhiying', 'Initials': 'Z', 'LastName': 'You', 'Affiliation': ''}, {'ForeName': 'Walter T', 'Initials': 'WT', 'LastName': 'Ambrosius', 'Affiliation': ''}, {'ForeName': 'Monique E', 'Initials': 'ME', 'LastName': 'Cho', 'Affiliation': ''}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Glasser', 'Affiliation': ''}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Lash', 'Affiliation': ''}, {'ForeName': 'Debra L', 'Initials': 'DL', 'LastName': 'Simmons', 'Affiliation': ''}, {'ForeName': 'Addison', 'Initials': 'A', 'LastName': 'Taylor', 'Affiliation': ''}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Weiner', 'Affiliation': ''}, {'ForeName': 'Anjay', 'Initials': 'A', 'LastName': 'Rastogi', 'Affiliation': ''}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Oparil', 'Affiliation': ''}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Supiano', 'Affiliation': ''}]",Clinical nephrology,['10.5414/CN109982'] 1946,32446675,"Influence of the Instructional Approach ""Mastery Learning"" versus ""See One, Do One"" on Acquiring Competencies in Abdomen Sonography: A Comparative Effectiveness Analysis.","Ultrasound is an important diagnostic tool in patients with abdominal pain and after injury. However, it is highly dependent on the skills and training of the examiner. Thus, ultrasound competencies should be acquired early during medical education. The instructional approach affects the retention and performance of skills. A promising approach is ""mastery learning."" The aim of the study was to evaluate the effectiveness of ""mastery learning"" compared with the ""see one, do one"" approach by performing a focused assessment of sonography for trauma (FAST) in undergraduate medical students based using an academic assessment tool (Objective Structured Clinical Examination [OSCE]). In a prospective controlled trial, 146 participants were randomly allocated to two groups (see one, do one and mastery learning) and trained in a 90-min module. In the see one, do one group, the trainer demonstrated the complete FAST routine, and then the students trained each other on it under supervision and received direct oral feedback from the tutors. In the mastery learning group, each student received a routing slip. The routing slip contained five levels of competence for the FAST routine, each of which had to be achieved (e.g., choosing the correct probe) and verified by the trainer before working toward the next competency level. The acquired competencies were assessed after training using the OSCE, which is a standardized practical exam using checklists. The mastery learning group attained 40.69 ± 5.6 points on average (of a maximum of 46 points), and the see one, do one group, 33.85 ± 7.7 points (p < 0.001). Mastery learning is an effective teaching method for undergraduate medical students performing FAST and is superior to the see one, do one approach, as assessed with the OSCE.",2020,"Mastery learning is an effective teaching method for undergraduate medical students performing FAST and is superior to the see one, do one approach, as assessed with the OSCE.","['patients with abdominal pain and after injury', '146 participants', 'undergraduate medical students', 'Abdomen Sonography']","['Mastery learning', 'mastery learning']",['retention and performance of skills'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0000737', 'cui_str': 'Abdominal pain'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0038495', 'cui_str': 'Medical student'}, {'cui': 'C0607422', 'cui_str': 'Abdoman (drug)'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}]","[{'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}]",146.0,0.0211243,"Mastery learning is an effective teaching method for undergraduate medical students performing FAST and is superior to the see one, do one approach, as assessed with the OSCE.","[{'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'Britz', 'Affiliation': 'Department of Trauma, Hand and Reconstructive Surgery, University Hospital Frankfurt, Goethe University, Frankfurt, Germany.'}, {'ForeName': 'Jasmina', 'Initials': 'J', 'LastName': 'Sterz', 'Affiliation': 'Department of Trauma, Hand and Reconstructive Surgery, University Hospital Frankfurt, Goethe University, Frankfurt, Germany.'}, {'ForeName': 'Sebastian H', 'Initials': 'SH', 'LastName': 'Voß', 'Affiliation': 'MVZ Voss, Aschaffenburg, Germany.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Carstensen', 'Affiliation': 'Department of Trauma, Hand and Reconstructive Surgery, University Hospital Frankfurt, Goethe University, Frankfurt, Germany.'}, {'ForeName': 'Aleksandra', 'Initials': 'A', 'LastName': 'Germanyuk', 'Affiliation': 'Department of Urology and Pediatric Urology, University of Saarland, Homburg, Germany.'}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Ruesseler', 'Affiliation': 'Department of Trauma, Hand and Reconstructive Surgery, University Hospital Frankfurt, Goethe University, Frankfurt, Germany. Electronic address: miriam.ruesseler@kgu.de.'}]",Ultrasound in medicine & biology,['10.1016/j.ultrasmedbio.2020.04.001'] 1947,32446706,A role for the right dorsolateral prefrontal cortex in enhancing regulation of both craving and negative emotions in internet gaming disorder: A randomized trial.,"Reward-seeking and relief from negative emotions are two central motivational drives underlying addictions. Impaired executive control over craving and negative emotions contributes to compulsive addictive behaviors. Neuroimaging evidence has implicated the prefrontal cortex (PFC) in regulating craving or emotions. This study aims at examining whether anodal transcranial direct current stimulation (tDCS) over a specific region of the PFC would enhance both regulation processes. Thirty-three men with internet gaming disorder received active (1.5 mA for 20 minutes) and sham tDCS over the right dorsolateral PFC (dlPFC) one week apart in a randomized order. During each stimulation session, participants regulated craving for gaming during a regulation of craving (ROC) task and negative emotions during an emotion regulation (ER) task using cognitive reappraisal. Subjective ratings of craving and negative emotions and skin conductance responses (SCRs) were recorded. For both craving and negative emotions, tDCS of the right dlPFC facilitated downregulation and upregulation: active relative to sham tDCS decreased ratings (ROC: 95% CI of difference -1.38 to -0.56, p < 0.001; ER: -1.65 to -0.70, p < 0.001) and/or SCRs (ROC: -1.99 to -0.41 μs, p = 0.004) for downregulation, and increased ratings (ROC: 0.24 to 0.82, p = 0.001; ER: 0.26 to 0.72, p < 0.001) for upregulation. These findings provide the first experimental evidence confirming that tDCS of the right dlPFC enhances both craving- and negative-emotion-regulation. This suggests a promising approach for concurrently enhancing executive control over two central motivational drives underlying addictions.",2020,"and/or SCRs (ROC: -1.99 to -0.41 μs, p = 0.004) for downregulation, and increased ratings (ROC: 0.24 to 0.82, p = 0.001; ER: 0.26 to 0.72, p < 0.001) for upregulation.","['Thirty-three men with internet gaming disorder received', 'internet gaming disorder']","['participants regulated craving for gaming during a regulation of craving (ROC) task and negative emotions during an emotion regulation (ER) task using cognitive reappraisal', 'anodal transcranial direct current stimulation (tDCS', 'active (1.5 mA for 20 minutes) and sham tDCS over the right dorsolateral PFC (dlPFC']",['Subjective ratings of craving and negative emotions and skin conductance responses (SCRs'],"[{'cui': 'C0450358', 'cui_str': '33'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C4760905', 'cui_str': 'Internet gaming disorder'}]","[{'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C4019080', 'cui_str': 'Prefrontal Cortex, Dorsolateral'}, {'cui': 'C2983598', 'cui_str': 'Dorsolateral'}, {'cui': 'C4521595', 'cui_str': 'US Military enlisted E3'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}]",33.0,0.110968,"and/or SCRs (ROC: -1.99 to -0.41 μs, p = 0.004) for downregulation, and increased ratings (ROC: 0.24 to 0.82, p = 0.001; ER: 0.26 to 0.72, p < 0.001) for upregulation.","[{'ForeName': 'Lu-Lu', 'Initials': 'LL', 'LastName': 'Wu', 'Affiliation': 'State Key Laboratory of Cognitive Neuroscience and Learning and IDG/McGovern Institute for Brain Research, Beijing Normal University, No. 19 XieJieKouWai Street, Haidian Strict 100875, Beijing, China.'}, {'ForeName': 'Marc N', 'Initials': 'MN', 'LastName': 'Potenza', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, New Haven, CT, USA; Child Study Center, Yale University School of Medicine, New Haven, CT, USA; Department of Neuroscience, Yale University School of Medicine, Connecticut Mental Health Center, New Haven, Connecticut Council on Problem Gambling, Wethersfield, CT, USA; Connecticut Council on Problem Gambling, Wethersfield, CT, USA; Connecticut Mental Health Center, New Haven, CT, USA.'}, {'ForeName': 'Nan', 'Initials': 'N', 'LastName': 'Zhou', 'Affiliation': 'Faculty of Education, Beijing Normal University, Beijing 100875, China.'}, {'ForeName': 'Hedy', 'Initials': 'H', 'LastName': 'Kober', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, New Haven, CT, USA; Department of Psychology, Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Xin-Hui', 'Initials': 'XH', 'LastName': 'Shi', 'Affiliation': 'State Key Laboratory of Cognitive Neuroscience and Learning and IDG/McGovern Institute for Brain Research, Beijing Normal University, No. 19 XieJieKouWai Street, Haidian Strict 100875, Beijing, China.'}, {'ForeName': 'Sarah W', 'Initials': 'SW', 'LastName': 'Yip', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, New Haven, CT, USA; Child Study Center, Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Jia-Hua', 'Initials': 'JH', 'LastName': 'Xu', 'Affiliation': 'State Key Laboratory of Cognitive Neuroscience and Learning and IDG/McGovern Institute for Brain Research, Beijing Normal University, No. 19 XieJieKouWai Street, Haidian Strict 100875, Beijing, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Zhu', 'Affiliation': 'State Key Laboratory of Cognitive Neuroscience and Learning and IDG/McGovern Institute for Brain Research, Beijing Normal University, No. 19 XieJieKouWai Street, Haidian Strict 100875, Beijing, China.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Wang', 'Affiliation': 'State Key Laboratory of Cognitive Neuroscience and Learning and IDG/McGovern Institute for Brain Research, Beijing Normal University, No. 19 XieJieKouWai Street, Haidian Strict 100875, Beijing, China.'}, {'ForeName': 'Guan-Qun', 'Initials': 'GQ', 'LastName': 'Liu', 'Affiliation': 'State Key Laboratory of Cognitive Neuroscience and Learning and IDG/McGovern Institute for Brain Research, Beijing Normal University, No. 19 XieJieKouWai Street, Haidian Strict 100875, Beijing, China.'}, {'ForeName': 'Jin-Tao', 'Initials': 'JT', 'LastName': 'Zhang', 'Affiliation': 'State Key Laboratory of Cognitive Neuroscience and Learning and IDG/McGovern Institute for Brain Research, Beijing Normal University, No. 19 XieJieKouWai Street, Haidian Strict 100875, Beijing, China; Beijing Key Lab of Applied Experimental Psychology, School of Psychology, Beijing Normal University, Beijing, China. Electronic address: zhangjintao@bnu.edu.cn.'}]",European neuropsychopharmacology : the journal of the European College of Neuropsychopharmacology,['10.1016/j.euroneuro.2020.04.003'] 1948,32452846,Cardiogenic shock: role of invasive cardiology.,"PURPOSE OF REVIEW Early revascularization significantly improved the outcome of patients with cardiogenic shock following acute myocardial infarction (AMI). Nevertheless, the mortality remains substantial, ranging between 40 and 50% after 30 days. The present review summarizes the current evidence regarding revascularization strategies, vascular access site and concomitant antiplatelet and antithrombotic treatment in infarct-related cardiogenic shock. RECENT FINDINGS On the basis of the SHOCK trial, early revascularization is the most relevant procedure to improve the outcome of patients with infarct-related cardiogenic shock. The majority of these patients present with multivessel coronary disease. The randomized CULPRIT-SHOCK trial showed that in the emergency setting, percutaneous coronary intervention (PCI) should be confined to the culprit lesion. Regarding vascular access site, no data derived from randomized controlled trials in cardiogenic shock are available. Emergency coronary artery bypass grafting (CABG) is nowadays rarely performed in cardiogenic shock with rates less than 5% but is still a treatment option if coronary anatomy is not amenable to PCI. Regarding antiplatelet treatment, a randomized trial testing the intravenous P2Y12 inhibitor cangrelor versus an oral P2Y12 inhibitor in infarct-related cardiogenic shock is currently being performed. SUMMARY Early revascularization is the cornerstone of treatment of infarct-related cardiogenic shock and should be confined to the culprit lesion in the emergency setting.",2020,"PURPOSE OF REVIEW Early revascularization significantly improved the outcome of patients with cardiogenic shock following acute myocardial infarction (AMI).","['patients with cardiogenic shock following acute myocardial infarction (AMI', 'patients with infarct-related cardiogenic shock']","['percutaneous coronary intervention (PCI', 'Emergency coronary artery bypass grafting (CABG', 'intravenous P2Y12 inhibitor cangrelor']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036980', 'cui_str': 'Cardiogenic shock'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction'}, {'cui': 'C0021308', 'cui_str': 'Infarct'}]","[{'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C1532296', 'cui_str': 'Emergency CABG'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C1121991', 'cui_str': 'cangrelor'}]",[],,0.1286,"PURPOSE OF REVIEW Early revascularization significantly improved the outcome of patients with cardiogenic shock following acute myocardial infarction (AMI).","[{'ForeName': 'Hans-Josef', 'Initials': 'HJ', 'LastName': 'Feistritzer', 'Affiliation': 'Department of Internal Medicine/Cardiology, Heart Center Leipzig at the University of Leipzig and Leipzig Heart Institute, Leipzig, Germany.'}, {'ForeName': 'Holger', 'Initials': 'H', 'LastName': 'Thiele', 'Affiliation': ''}, {'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Desch', 'Affiliation': ''}]",Current opinion in critical care,['10.1097/MCC.0000000000000738'] 1949,32453453,Ultra-Early Blood Pressure Reduction Attenuates Hematoma Growth and Improves Outcome in Intracerebral Hemorrhage.,"OBJECTIVE The aim was to investigate whether intensive blood pressure treatment is associated with less hematoma growth and better outcome in intracerebral hemorrhage (ICH) patients who received intravenous nicardipine treatment ≤2 hours after onset of symptoms. METHODS A post-hoc exploratory analysis of the Antihypertensive Treatment of Acute Cerebral Hemorrhage 2 (ATACH-2) trial was performed. This was a multicenter, international, open-label, randomized clinical trial, in which patients with primary ICH were allocated to intensive versus standard blood pressure treatment with nicardipine ≤4.5 hours after onset of symptoms. We have included 913 patients with complete imaging and follow-up data in the present analysis. RESULTS Among the 913 included patients, 354 (38.7%) had intravenous nicardipine treatment initiated within 2 hours. In this subgroup of patients treated within 2 hours, the frequency of ICH expansion was significantly lower in the intensive blood pressure reduction group compared with the standard treatment group (p = 0.02). Multivariable analysis showed that ultra-early intensive blood pressure treatment was associated with a decreased risk of hematoma growth (odds ratio, 0.56; 95% confidence interval [CI], 0.34-0.92; p = 0.02), higher rate of functional independence (odds ratio, 2.17; 95% CI, 1.28-3.68; p = 0.004), and good outcome (odds ratio, 1.68; 95% CI, 1.01-2.83; p = 0.048) at 90 days. Ultra-early intensive blood pressure reduction was associated with a favorable shift in modified Rankin Scale score distribution at 3 months (p = 0.04). INTERPRETATION In a subgroup of ICH patients with elevated blood pressure given intravenous nicardipine ≤2 hours after onset of symptoms, intensive blood pressure reduction was associated with reduced hematoma growth and improved functional outcome. ANN NEUROL 2020.",2020,"Ultra-early intensive blood pressure reduction was associated with a favorable shift in modified Rankin Scale score distribution at 3 months (p = 0.04). ","['Intracerebral Hemorrhage', '913 patients with complete imaging and follow-up data in the present analysis', 'ICH patients who received intravenous', 'patients with primary ICH']","['intensive blood pressure treatment', 'intensive versus standard blood pressure treatment with nicardipine', 'Ultra-early Blood Pressure Reduction', 'nicardipine']","['hematoma growth and improved functional outcome', 'modified Rankin Scale score distribution', 'rate of functional independence', 'Ultra-early intensive blood pressure reduction', 'elevated blood pressure', 'risk of hematoma growth', 'frequency of ICH expansion', 'intensive blood pressure reduction']","[{'cui': 'C2937358', 'cui_str': 'Cerebral hemorrhage'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0019191', 'cui_str': 'Infectious Canine Hepatitis'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0205225', 'cui_str': 'Principal'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0028005', 'cui_str': 'Nicardipine'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]","[{'cui': 'C0018944', 'cui_str': 'Hematoma'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0019191', 'cui_str': 'Infectious Canine Hepatitis'}]",913.0,0.129574,"Ultra-early intensive blood pressure reduction was associated with a favorable shift in modified Rankin Scale score distribution at 3 months (p = 0.04). ","[{'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'Department of Neurology, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Andrew D', 'Initials': 'AD', 'LastName': 'Warren', 'Affiliation': 'Department of Neurology, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Adnan I', 'Initials': 'AI', 'LastName': 'Qureshi', 'Affiliation': 'Zeenat Qureshi Stroke Institute, St. Cloud, MN, USA.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Morotti', 'Affiliation': 'Department of Neurology and Neurorehabilitation, IRCCS Mondino Foundation, Pavia, Italy.'}, {'ForeName': 'Guido J', 'Initials': 'GJ', 'LastName': 'Falcone', 'Affiliation': 'Department of Neurology, Yale School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Kevin N', 'Initials': 'KN', 'LastName': 'Sheth', 'Affiliation': 'Department of Neurology, Yale School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Ashkan', 'Initials': 'A', 'LastName': 'Shoamanesh', 'Affiliation': 'Division of Neurology, McMaster University/Population Health Research Institute, Hamilton, Ontario, Canada.'}, {'ForeName': 'Dar', 'Initials': 'D', 'LastName': 'Dowlatshahi', 'Affiliation': 'Department of Medicine (Neurology), Ottawa Hospital Research Institute, University of Ottawa, Ottawa, Ontario, Canada.'}, {'ForeName': 'Anand', 'Initials': 'A', 'LastName': 'Viswanathan', 'Affiliation': 'Department of Neurology, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Joshua N', 'Initials': 'JN', 'LastName': 'Goldstein', 'Affiliation': 'Division of Neurocritical Care and Emergency Neurology, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.'}]",Annals of neurology,['10.1002/ana.25793'] 1950,32450456,The impact of pre-procedure heart rate on adverse clinical outcomes in patients undergoing percutaneous coronary intervention: Results from a 2-year follow-up of the GLOBAL LEADERS trial.,"BACKGROUND AND AIMS The prognostic impact of pre-procedure heart rate (PHR) following percutaneous coronary intervention (PCI) has not yet been fully investigated. This post-hoc analysis sought to assess the impact of PHR on medium-term outcomes among patients having PCI, who were enrolled in the ""all-comers"" GLOBAL LEADERS trial. METHODS AND RESULTS The primary endpoint (composite of all-cause death or new Q-wave myocardial infarction [MI]) and key secondary safety endpoint (bleeding according to Bleeding Academic Research Consortium [BARC] type 3 or 5) were assessed at 2 years. PHR was available in 15,855 patients, and when evaluated as a continuous variable (5 bpm increase) and following adjustment using multivariate Cox regression, it significantly correlated with the primary endpoint (hazard ratio [HR] 1.06, 95% confidence interval [CI] 1.03-1.09, p < 0.001). Using dichotomous cut-off criteria, a PHR>67 bpm was associated with increased all-cause mortality (HR 1.38, 95%CI 1.13-1.69, p = 0.002) and more frequent new Q-wave MI (HR 1.41, 95%CI 1.02-1.93, p = 0.037). No significant association was found between PHR and BARC 3 or 5 bleeding (HR 1.04, 95% CI 0.99-1.09, p = 0.099). There was no interaction with the primary (p-inter = 0.236) or secondary endpoint (p-inter = 0.154) when high and low PHR was analyzed according to different antiplatelet strategies. CONCLUSIONS Elevated PHR was an independent predictor of all-cause mortality at 2 years following PCI in the ""all-comer"" GLOBAL LEADERS trial. The prognostic value of increased PHR on outcomes was not affected by the different antiplatelet strategies in this trial.",2020,"No significant association was found between PHR and BARC 3 or 5 bleeding (HR 1.04, 95% CI 0.99-1.09, p = 0.099).","['patients undergoing percutaneous coronary intervention', 'patients having PCI, who were enrolled in the ""all-comers"" GLOBAL LEADERS trial']",['percutaneous coronary intervention (PCI'],"['PHR and BARC 3 or 5 bleeding', 'primary endpoint (composite of all-cause death or new Q-wave myocardial infarction [MI]) and key secondary safety endpoint (bleeding according to Bleeding Academic Research Consortium [BARC] type 3 or 5', 'PHR']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}]","[{'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0429089', 'cui_str': 'Electrocardiogram Q waves'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0441731', 'cui_str': 'Type 3'}]",,0.296061,"No significant association was found between PHR and BARC 3 or 5 bleeding (HR 1.04, 95% CI 0.99-1.09, p = 0.099).","[{'ForeName': 'Rutao', 'Initials': 'R', 'LastName': 'Wang', 'Affiliation': ""Department of Cardiology, Xijing Hospital, Fourth Military Medical University, Xi'an, China; Department of Cardiology, Radboudumc, Nijmegen, the Netherlands; Department of Cardiology, National University of Ireland, Galway (NUIG), Galway, Ireland.""}, {'ForeName': 'Kuniaki', 'Initials': 'K', 'LastName': 'Takahashi', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Heart Center, Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam, the Netherlands.'}, {'ForeName': 'Ply', 'Initials': 'P', 'LastName': 'Chichareon', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Heart Center, Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam, the Netherlands; Cardiology Unit, Department of Internal Medicine, Faculty of Medicine, Prince of Songkla University, Songkhla, Thailand.'}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Gao', 'Affiliation': ""Department of Cardiology, Xijing Hospital, Fourth Military Medical University, Xi'an, China; Department of Cardiology, Radboudumc, Nijmegen, the Netherlands; Department of Cardiology, National University of Ireland, Galway (NUIG), Galway, Ireland.""}, {'ForeName': 'Norihiro', 'Initials': 'N', 'LastName': 'Kogame', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Heart Center, Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam, the Netherlands.'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Modolo', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Heart Center, Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam, the Netherlands; Department of Internal Medicine, Cardiology Division, University of Campinas (UNICAMP), Campinas, Brazil.'}, {'ForeName': 'Mariusz', 'Initials': 'M', 'LastName': 'Tomaniak', 'Affiliation': 'Department of Cardiology, Erasmus Medical University Center, Thorax Centre, Rotterdam, the Netherlands; First Department of Cardiology, Medical University of Warsaw, Warsaw, Poland.'}, {'ForeName': 'Hideyuki', 'Initials': 'H', 'LastName': 'Kawashima', 'Affiliation': 'Department of Cardiology, National University of Ireland, Galway (NUIG), Galway, Ireland; Amsterdam UMC, University of Amsterdam, Heart Center, Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam, the Netherlands.'}, {'ForeName': 'Masafumi', 'Initials': 'M', 'LastName': 'Ono', 'Affiliation': 'Department of Cardiology, National University of Ireland, Galway (NUIG), Galway, Ireland; Amsterdam UMC, University of Amsterdam, Heart Center, Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam, the Netherlands.'}, {'ForeName': 'Hironori', 'Initials': 'H', 'LastName': 'Hara', 'Affiliation': 'Department of Cardiology, National University of Ireland, Galway (NUIG), Galway, Ireland; Amsterdam UMC, University of Amsterdam, Heart Center, Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam, the Netherlands.'}, {'ForeName': 'Volker', 'Initials': 'V', 'LastName': 'Schächinger', 'Affiliation': 'Klinikum Fulda, Medizinische Klinik I, Fulda, Germany.'}, {'ForeName': 'Gincho', 'Initials': 'G', 'LastName': 'Tonev', 'Affiliation': ""Multi-profile Hospital for Active Treatment, St George's University, Plovdiv, Bulgaria.""}, {'ForeName': 'Imre', 'Initials': 'I', 'LastName': 'Ungi', 'Affiliation': 'Division of Invasive Cardiology, Second Department of Internal Medicine and Cardiology Center, University of Szeged, Szeged, Hungary.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Botelho', 'Affiliation': 'CT / Instituto Do Coracao Do Triangulo Mineiro, Uberlandia, Brazil.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Eeckhout', 'Affiliation': 'Department of Cardiology, Lausanne University Hospital, Switzerland.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Hamm', 'Affiliation': 'Kerckhoff Heart Center, Campus University of Giessen, Bad Nauheim, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Jüni', 'Affiliation': ""Applied Health Research Centre, Li Ka Shing Knowledge Institute, St Michael's Hospital, University of Toronto, Toronto, Canada.""}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Vranckx', 'Affiliation': 'Department of Cardiology and Critical Care Medicine, Hartcentrum Hasselt, Jessa Ziekenhuis, Hasselt, Belgium.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Windecker', 'Affiliation': 'Department of Cardiology, Bern University Hospital, Bern, Switzerland.'}, {'ForeName': 'Scot', 'Initials': 'S', 'LastName': 'Garg', 'Affiliation': 'East Lancashire Hospitals NHS Trust, Blackburn, Lancashire, United Kingdom.'}, {'ForeName': 'Robert Jan', 'Initials': 'RJ', 'LastName': 'Van Geuns', 'Affiliation': 'Department of Cardiology, Radboudumc, Nijmegen, the Netherlands.'}, {'ForeName': 'Yoshinobu', 'Initials': 'Y', 'LastName': 'Onuma', 'Affiliation': 'Department of Cardiology, National University of Ireland, Galway (NUIG), Galway, Ireland; Department of Cardiology, Erasmus Medical University Center, Thorax Centre, Rotterdam, the Netherlands.'}, {'ForeName': 'Patrick W', 'Initials': 'PW', 'LastName': 'Serruys', 'Affiliation': 'Department of Cardiology, National University of Ireland, Galway (NUIG), Galway, Ireland; National Heart and Lung Institute, Imperial College London, London, UK. Electronic address: patrick.w.j.c.serruys@gmail.com.'}]",Atherosclerosis,['10.1016/j.atherosclerosis.2020.04.010'] 1951,32454209,"Psilocybin acutely alters the functional connectivity of the claustrum with brain networks that support perception, memory, and attention.","Psychedelic drugs, including the serotonin 2a (5-HT 2A ) receptor partial agonist psilocybin, are receiving renewed attention for their possible efficacy in treating a variety of neuropsychiatric disorders. Psilocybin induces widespread dysregulation of cortical activity, but circuit-level mechanisms underlying this effect are unclear. The claustrum is a subcortical nucleus that highly expresses 5-HT 2A receptors and provides glutamatergic inputs to arguably all areas of the cerebral cortex. We therefore tested the hypothesis that psilocybin modulates claustrum function in humans. Fifteen healthy participants (10M, 5F) completed this within-subjects study in which whole-brain resting-state blood-oxygenation level-dependent (BOLD) signal was measured 100 ​min after blinded oral administration of placebo and 10 mg/70 ​kg psilocybin. Left and right claustrum signal was isolated using small region confound correction. Psilocybin significantly decreased both the amplitude of low frequency fluctuations as well as the variance of BOLD signal in the left and right claustrum. Psilocybin also significantly decreased functional connectivity of the right claustrum with auditory and default mode networks (DMN), increased right claustrum connectivity with the fronto-parietal task control network (FPTC), and decreased left claustrum connectivity with the FPTC. DMN integrity was associated with right-claustrum connectivity with the DMN, while FPTC integrity and modularity were associated with right claustrum and left claustrum connectivity with the FPTC, respectively. Subjective effects of psilocybin predicted changes in the amplitude of low frequency fluctuations and the variance of BOLD signal in the left and right claustrum. Observed effects were specific to claustrum, compared to flanking regions of interest (the left and right insula and putamen). This study used a pharmacological intervention to provide the first empirical evidence in any species for a significant role of 5-HT 2A receptor signaling in claustrum functioning, and supports a possible role of the claustrum in the subjective and therapeutic effects of psilocybin.",2020,Psilocybin significantly decreased both the amplitude of low frequency fluctuations as well as the variance of BOLD signal in the left and right claustrum.,"['Fifteen healthy participants (10M, 5F) completed this within-subjects study in which whole-brain resting-state blood-oxygenation level-dependent (BOLD) signal was measured 100\u202fmin after blinded oral administration of', 'humans']","['psilocybin', 'placebo and 10 mg/70\u202fkg psilocybin', 'Psilocybin', 'serotonin 2a (5-HT 2A ) receptor partial agonist psilocybin']","['BOLD signal', 'amplitude of low frequency fluctuations', 'functional connectivity of the right claustrum with auditory and default mode networks (DMN), increased right claustrum connectivity']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0001563', 'cui_str': 'Medication administration: oral'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}]","[{'cui': 'C0033850', 'cui_str': 'Psilocybine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0036751', 'cui_str': 'Serotonin'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0243192', 'cui_str': 'agonists'}]","[{'cui': 'C0037083', 'cui_str': 'Signal transduction'}, {'cui': 'C0205213', 'cui_str': 'Low frequency'}, {'cui': 'C0231239', 'cui_str': 'Fluctuation'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0008910', 'cui_str': 'Claustral structure'}, {'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0205217', 'cui_str': 'Increased'}]",15.0,0.0313229,Psilocybin significantly decreased both the amplitude of low frequency fluctuations as well as the variance of BOLD signal in the left and right claustrum.,"[{'ForeName': 'Frederick S', 'Initials': 'FS', 'LastName': 'Barrett', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore, MD, 21224, USA; Center for Psychedelic and Consciousness Research, Johns Hopkins University School of Medicine, Baltimore, MD, 21224, USA. Electronic address: fbarrett@jhmi.edu.'}, {'ForeName': 'Samuel R', 'Initials': 'SR', 'LastName': 'Krimmel', 'Affiliation': 'Department of Neural and Pain Sciences, School of Dentistry, and Center to Advance Chronic Pain Research, University of Maryland, Baltimore, MD, 21201, USA.'}, {'ForeName': 'Roland R', 'Initials': 'RR', 'LastName': 'Griffiths', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine, Baltimore, MD, 21224, USA; Center for Psychedelic and Consciousness Research, Johns Hopkins University School of Medicine, Baltimore, MD, 21224, USA; Department of Neuroscience, Johns Hopkins University School of Medicine, Baltimore, MD, 21224, USA.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Seminowicz', 'Affiliation': 'Department of Neural and Pain Sciences, School of Dentistry, and Center to Advance Chronic Pain Research, University of Maryland, Baltimore, MD, 21201, USA.'}, {'ForeName': 'Brian N', 'Initials': 'BN', 'LastName': 'Mathur', 'Affiliation': 'Department of Pharmacology, School of Medicine, University of Maryland, Baltimore, MD, 21201, USA.'}]",NeuroImage,['10.1016/j.neuroimage.2020.116980'] 1952,32457366,Efficacy of water spray for evaporative cooling in athletes with spinal cord injury.,"STUDY DESIGN Interventional crossover study. OBJECTIVE Spinal cord injury (SCI) disrupts afferent input to the hypothalamus and impairs efferent vaso- and sudomotor output, especially in lesions above the sympathetic chain (T1-L2). In consequence, persons with SCI under heat stress experience impairment in the ability to dissipate heat proportional to the lesion level. Thermoregulatory dysfunction places an individual at high risk of hyperthermia, which can be life threatening, especially for athletes with SCI during exercise. Current evidence on therapeutic cooling techniques in athletes with SCI is limited, but basic physiologic and research data suggest water spray (WS) might be efficacious, particularly in athletes with tetraplegia (TP), who are most impaired in thermoregulation. The aim of this study was to evaluate the effect of WS on core temperature (Tc) during exercise in athletes with SCI. SETTING Texas, USA. METHODS Eleven individuals with SCI: seven with TP, four with paraplegia (PP); and sixteen able-bodied (AB) controls underwent a wheelchair intermittent sprint exercise for 90 min under two conditions: (1) WS application every 15 min and (2) control (C), without WS. Tc was measured every 15 min and was analyzed for the effect of group (TP, PP, and AB) and time. Change in Tc (ΔTc) was also compared between groups. RESULTS ΔTc was significantly higher in TP vs. PP (p < 0.0001) and TP vs. AB (p < 0.0001) groups under C treatment. WS significantly attenuated ΔTc in TP (p = 0.001), but did not change ΔTc in PP or AB. CONCLUSION WS effectively attenuated Tc elevation during exercise in athletes with TP. SPONSORSHIP Texas chapter of the Paralyzed Veterans of America.",2019,"WS significantly attenuated ΔTc in TP (p = 0.001), but did not change ΔTc in PP or AB. CONCLUSION WS effectively attenuated Tc elevation during exercise in athletes with TP. ","['Eleven individuals with SCI: seven with TP, four with paraplegia (PP); and sixteen able-bodied (AB) controls underwent a', 'athletes with tetraplegia (TP', 'SPONSORSHIP\n\n\nTexas chapter of the Paralyzed Veterans of America', 'athletes with spinal cord injury', 'athletes with SCI.\nSETTING\n\n\nTexas, USA', 'athletes with SCI']","['wheelchair intermittent sprint exercise for 90\u2009min under two conditions: (1) WS application every 15\u2009min and (2) control (C), without WS', 'water spray']","['core temperature (Tc', 'TP vs. PP', 'Change in Tc (ΔTc', 'Tc elevation']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0037929', 'cui_str': 'Spinal cord injury'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0030486', 'cui_str': 'Paraplegia'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0034372', 'cui_str': 'Tetraplegia'}, {'cui': 'C0039711', 'cui_str': 'Texas'}, {'cui': 'C0522224', 'cui_str': 'Paralysis'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0002454', 'cui_str': 'America'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}]","[{'cui': 'C0043143', 'cui_str': 'Wheelchair'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C1154182', 'cui_str': 'Spray dose form'}]","[{'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}]",11.0,0.0318801,"WS significantly attenuated ΔTc in TP (p = 0.001), but did not change ΔTc in PP or AB. CONCLUSION WS effectively attenuated Tc elevation during exercise in athletes with TP. ","[{'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Trbovich', 'Affiliation': 'Department of Rehabilitation Medicine, University of Texas Health Science Center at San Antonio, San Antonio, TX, USA. trbovichm@uthscsa.edu.'}, {'ForeName': 'Wouter', 'Initials': 'W', 'LastName': 'Koek', 'Affiliation': 'Department of Psychiatry, University of Texas Health Science Center at San Antonio, San Antonio, TX, USA.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Ortega', 'Affiliation': 'School of Health Professions, Physical Therapy Department, University of Texas Health Science Center at San Antonio, San Antonio, TX, USA.'}]",Spinal cord series and cases,['10.1038/s41394-019-0194-8'] 1953,32462829,Addition of Amlodipine or Valsartan for Improvement of Diastolic Dysfunction Associated with Hypertension.,"BACKGROUND Hypertensive patients are at increased risk of diastolic dysfunction. The hypothesis of this study was that addition of amlodipine would be superior to valsartan in improving diastolic dysfunction associated with hypertension. METHODS In this randomized trial, we randomly assigned 104 controlled, hypertensive patients with diastolic dysfunction to receive either amlodipine 2.5 mg or valsartan 40 mg, in addition to antihypertensive therapy. The primary end point was the change in the ratio of early mitral inflow velocity to early mitral annular relaxation velocity (E/E') from baseline to the 6-month follow-up. Secondary end points included changes in systolic blood pressure (SBP), left ventricular (LV) mass index, and left atrial volume index. RESULTS SBP decreased significantly from baseline in both treatment groups (p < 0.001). E/E' decreased significantly from 13.0 ± 2.2 to 12.0 ± 2.7 in the amlodipine arm and from 14.4 ± 4.3 to 12.7 ± 3.7 in the valsartan arm (p < 0.01 in both groups). The change of E/E' was not significantly different between treatment groups (p = 0.25). There were also no significant between-group differences regarding the changes in SBP, LV mass index, and left atrial volume index. Two patients (3.8%) in the amlodipine group and 1 (16%) in the valsartan group had serious adverse event. CONCLUSIONS In this randomized trial involving controlled hypertensive patients, addition of amlodipine or valsartan was associated with an improvement of diastolic dysfunction, but the effects on diastolic dysfunction did not differ significantly between the treatment groups.",2020,"There were also no significant between-group differences regarding the changes in SBP, LV mass index, and left atrial volume index.","['hypertensive patients with diastolic dysfunction to receive either', 'controlled hypertensive patients', 'Hypertensive patients']","['valsartan', 'amlodipine', 'Amlodipine or Valsartan', 'amlodipine or valsartan', 'amlodipine 2.5 mg or valsartan 40 mg, in addition to antihypertensive therapy']","['diastolic dysfunction', 'SBP, LV mass index, and left atrial volume index', 'Diastolic Dysfunction', 'systolic blood pressure (SBP), left ventricular (LV) mass index, and left atrial volume index', 'serious adverse event', 'risk of diastolic dysfunction', 'change in the ratio of early mitral inflow velocity to early mitral annular relaxation velocity (E/E', 'E/E', 'SBP', 'change of E/E']","[{'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0520863', 'cui_str': 'Diastolic dysfunction'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0216784', 'cui_str': 'valsartan'}, {'cui': 'C0051696', 'cui_str': 'Amlodipine'}, {'cui': 'C1124795', 'cui_str': 'Amlodipine 2.5 MG'}, {'cui': 'C1132897', 'cui_str': 'valsartan 40 MG'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0585941', 'cui_str': 'Antihypertensive therapy'}]","[{'cui': 'C0520863', 'cui_str': 'Diastolic dysfunction'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0455825', 'cui_str': 'Left ventricular mass'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0018792', 'cui_str': 'Atrial structure'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0521164', 'cui_str': 'Annular shape'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",104.0,0.0345762,"There were also no significant between-group differences regarding the changes in SBP, LV mass index, and left atrial volume index.","[{'ForeName': 'Jin Kyung', 'Initials': 'JK', 'LastName': 'Oh', 'Affiliation': 'Division of Cardiology, Asan Medical Center, College of Medicine, University of Ulsan, Seoul, Korea.'}, {'ForeName': 'Jeong Sook', 'Initials': 'JS', 'LastName': 'Seo', 'Affiliation': 'Division of Cardiology, Inje University Busan Paik Hospital, Busan, Korea.'}, {'ForeName': 'Yong Hyun', 'Initials': 'YH', 'LastName': 'Park', 'Affiliation': 'Division of Cardiology, Pusan National University Yangsan Hospital, Yangsan, Korea.'}, {'ForeName': 'Jae Hyeong', 'Initials': 'JH', 'LastName': 'Park', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Chungnam National University Hospital, Chungnam National University College of Medicine, Daejeon, Korea.'}, {'ForeName': 'Seung Ah', 'Initials': 'SA', 'LastName': 'Lee', 'Affiliation': 'Division of Cardiology, Asan Medical Center, College of Medicine, University of Ulsan, Seoul, Korea.'}, {'ForeName': 'Sahmin', 'Initials': 'S', 'LastName': 'Lee', 'Affiliation': 'Division of Cardiology, Asan Medical Center, College of Medicine, University of Ulsan, Seoul, Korea.'}, {'ForeName': 'Dae Hee', 'Initials': 'DH', 'LastName': 'Kim', 'Affiliation': 'Division of Cardiology, Asan Medical Center, College of Medicine, University of Ulsan, Seoul, Korea.'}, {'ForeName': 'Jong Min', 'Initials': 'JM', 'LastName': 'Song', 'Affiliation': 'Division of Cardiology, Asan Medical Center, College of Medicine, University of Ulsan, Seoul, Korea.'}, {'ForeName': 'Duk Hyun', 'Initials': 'DH', 'LastName': 'Kang', 'Affiliation': 'Division of Cardiology, Asan Medical Center, College of Medicine, University of Ulsan, Seoul, Korea. dhkang@amc.seoul.kr.'}]",Journal of cardiovascular imaging,['10.4250/jcvi.2020.0005'] 1954,32462856,"Effects of essential amino acid supplementation on pain in the elderly with hip fractures: a pilot, double-blind, placebo-controlled, randomised clinical trial.",,2020,,['elderly with hip fractures'],"['essential amino acid supplementation', 'placebo']",['pain'],"[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0019557', 'cui_str': 'Hip fracture'}]","[{'cui': 'C0556083', 'cui_str': 'Essential amino acid supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}]",,0.620566,,"[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Rondanelli', 'Affiliation': 'IRCCS Mondino Foundation, Pavia, Italy.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Guido', 'Affiliation': 'Epidemiology Unit, Agency for Health Protection of Milan, Milan, Italy.'}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Faliva', 'Affiliation': ""Endocrinology and Nutrition Unit, Azienda di Servizi alla Persona ''Istituto Santa Margherita'', University of Pavia, Pavia, Italy.""}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Gasparri', 'Affiliation': ""Endocrinology and Nutrition Unit, Azienda di Servizi alla Persona ''Istituto Santa Margherita'', University of Pavia, Pavia, Italy.""}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Peroni', 'Affiliation': ""Endocrinology and Nutrition Unit, Azienda di Servizi alla Persona ''Istituto Santa Margherita'', University of Pavia, Pavia, Italy.""}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Iannello', 'Affiliation': ""General Management, Azienda di Servizi alla Persona ''Istituto Santa Margherita'', Pavia, Italy.""}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Nichetti', 'Affiliation': ""Endocrinology and Nutrition Unit, Azienda di Servizi alla Persona ''Istituto Santa Margherita'', University of Pavia, Pavia, Italy.""}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Naso', 'Affiliation': ""Endocrinology and Nutrition Unit, Azienda di Servizi alla Persona ''Istituto Santa Margherita'', University of Pavia, Pavia, Italy.""}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Infantino', 'Affiliation': 'University of Bari, Department of Biomedical Science and Human Oncology, Bari, Italy.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Spadaccini', 'Affiliation': ""Endocrinology and Nutrition Unit, Azienda di Servizi alla Persona ''Istituto Santa Margherita'', University of Pavia, Pavia, Italy.""}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Perna', 'Affiliation': 'University of Bahrain, Department of Biology, College of Science, Sakhir Campus, Kingdom of Bahrain.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Aquilani', 'Affiliation': 'Department of Biology and Biotechnology University of Pavia.'}]",Journal of biological regulators and homeostatic agents,['10.23812/19-452-L-46'] 1955,32580883,"Hypofractionated breast radiotherapy for 1 week versus 3 weeks (FAST-Forward): 5-year efficacy and late normal tissue effects results from a multicentre, non-inferiority, randomised, phase 3 trial.","BACKGROUND We aimed to identify a five-fraction schedule of adjuvant radiotherapy (radiation therapy) delivered in 1 week that is non-inferior in terms of local cancer control and is as safe as an international standard 15-fraction regimen after primary surgery for early breast cancer. Here, we present 5-year results of the FAST-Forward trial. METHODS FAST-Forward is a multicentre, phase 3, randomised, non-inferiority trial done at 97 hospitals (47 radiotherapy centres and 50 referring hospitals) in the UK. Patients aged at least 18 years with invasive carcinoma of the breast (pT1-3, pN0-1, M0) after breast conservation surgery or mastectomy were eligible. We randomly allocated patients to either 40 Gy in 15 fractions (over 3 weeks), 27 Gy in five fractions (over 1 week), or 26 Gy in five fractions (over 1 week) to the whole breast or chest wall. Allocation was not masked because of the nature of the intervention. The primary endpoint was ipsilateral breast tumour relapse; assuming a 2% 5-year incidence for 40 Gy, non-inferiority was predefined as ≤1·6% excess for five-fraction schedules (critical hazard ratio [HR] of 1·81). Normal tissue effects were assessed by clinicians, patients, and from photographs. This trial is registered at isrctn.com, ISRCTN19906132. FINDINGS Between Nov 24, 2011, and June 19, 2014, we recruited and obtained consent from 4096 patients from 97 UK centres, of whom 1361 were assigned to the 40 Gy schedule, 1367 to the 27 Gy schedule, and 1368 to the 26 Gy schedule. At a median follow-up of 71·5 months (IQR 71·3 to 71·7), the primary endpoint event occurred in 79 patients (31 in the 40 Gy group, 27 in the 27 Gy group, and 21 in the 26 Gy group); HRs versus 40 Gy in 15 fractions were 0·86 (95% CI 0·51 to 1·44) for 27 Gy in five fractions and 0·67 (0·38 to 1·16) for 26 Gy in five fractions. 5-year incidence of ipsilateral breast tumour relapse after 40 Gy was 2·1% (1·4 to 3·1); estimated absolute differences versus 40 Gy in 15 fractions were -0·3% (-1·0 to 0·9) for 27 Gy in five fractions (probability of incorrectly accepting an inferior five-fraction schedule: p=0·0022 vs 40 Gy in 15 fractions) and -0·7% (-1·3 to 0·3) for 26 Gy in five fractions (p=0·00019 vs 40 Gy in 15 fractions). At 5 years, any moderate or marked clinician-assessed normal tissue effects in the breast or chest wall was reported for 98 of 986 (9·9%) 40 Gy patients, 155 (15·4%) of 1005 27 Gy patients, and 121 of 1020 (11·9%) 26 Gy patients. Across all clinician assessments from 1-5 years, odds ratios versus 40 Gy in 15 fractions were 1·55 (95% CI 1·32 to 1·83, p<0·0001) for 27 Gy in five fractions and 1·12 (0·94 to 1·34, p=0·20) for 26 Gy in five fractions. Patient and photographic assessments showed higher normal tissue effect risk for 27 Gy versus 40 Gy but not for 26 Gy versus 40 Gy. INTERPRETATION 26 Gy in five fractions over 1 week is non-inferior to the standard of 40 Gy in 15 fractions over 3 weeks for local tumour control, and is as safe in terms of normal tissue effects up to 5 years for patients prescribed adjuvant local radiotherapy after primary surgery for early-stage breast cancer. FUNDING National Institute for Health Research Health Technology Assessment Programme.",2020,incidence of ipsilateral breast tumour relapse after 40 Gy was 2·1% (1·4 to 3·1); estimated absolute differences versus 40 Gy in 15 fractions were -0·3% (-1·0 to 0·9) for 27 Gy in five fractions (probability of incorrectly accepting an inferior five-fraction schedule: p=0·0022 vs 40 Gy in 15 fractions) and -0·7% (-1·3 to 0·3) for 26 Gy in five fractions (p=0·00019 vs 40 Gy in 15 fractions).,"['Between Nov 24, 2011, and June 19, 2014', '4096 patients from 97 UK centres, of whom 1361 were assigned to the 40 Gy schedule, 1367 to the 27 Gy schedule, and 1368 to the 26 Gy schedule', 'Patients aged at least 18 years with invasive carcinoma of the breast (pT1-3, pN0-1, M0) after breast conservation surgery or mastectomy were eligible', '97 hospitals (47 radiotherapy centres and 50 referring hospitals) in the UK']","['adjuvant radiotherapy (radiation therapy', 'adjuvant local radiotherapy', 'Hypofractionated breast radiotherapy']","['normal tissue effect risk', 'Normal tissue effects', 'ipsilateral breast tumour relapse', 'moderate or marked clinician-assessed normal tissue effects', '5-year incidence for 40 Gy, non-inferiority', 'incidence of ipsilateral breast tumour relapse']","[{'cui': 'C0949920', 'cui_str': 'Norovirus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0853879', 'cui_str': 'Invasive carcinoma of breast'}, {'cui': 'C0332391', 'cui_str': 'pT1 category'}, {'cui': 'C0332396', 'cui_str': 'pN0 category'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0024881', 'cui_str': 'Mastectomy'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}]","[{'cui': 'C0242939', 'cui_str': 'Adjuvant Radiotherapy'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0852216', 'cui_str': 'Breast radiotherapies'}]","[{'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0441989', 'cui_str': 'Ipsilateral'}, {'cui': 'C1458155', 'cui_str': 'Neoplasm of breast'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0522501', 'cui_str': 'Massive'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0237666', 'cui_str': 'Inferiority feeling'}]",4096.0,0.236289,incidence of ipsilateral breast tumour relapse after 40 Gy was 2·1% (1·4 to 3·1); estimated absolute differences versus 40 Gy in 15 fractions were -0·3% (-1·0 to 0·9) for 27 Gy in five fractions (probability of incorrectly accepting an inferior five-fraction schedule: p=0·0022 vs 40 Gy in 15 fractions) and -0·7% (-1·3 to 0·3) for 26 Gy in five fractions (p=0·00019 vs 40 Gy in 15 fractions).,"[{'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Murray Brunt', 'Affiliation': 'University Hospitals of North Midlands and University of Keele, Stoke on Trent, UK; Clinical Trials and Statistics Unit, The Institute of Cancer Research, Sutton, London, UK. Electronic address: fastforward-icrctsu@icr.ac.uk.'}, {'ForeName': 'Joanne S', 'Initials': 'JS', 'LastName': 'Haviland', 'Affiliation': 'Clinical Trials and Statistics Unit, The Institute of Cancer Research, Sutton, London, UK.'}, {'ForeName': 'Duncan A', 'Initials': 'DA', 'LastName': 'Wheatley', 'Affiliation': 'Royal Cornwall Hospital, Treliske, Truro, UK.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Sydenham', 'Affiliation': 'Clinical Trials and Statistics Unit, The Institute of Cancer Research, Sutton, London, UK.'}, {'ForeName': 'Abdulla', 'Initials': 'A', 'LastName': 'Alhasso', 'Affiliation': 'Beatson West of Scotland Cancer Centre, Glasgow, UK.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Bloomfield', 'Affiliation': 'Brighton and Sussex University Hospitals, Brighton, UK.'}, {'ForeName': 'Charlie', 'Initials': 'C', 'LastName': 'Chan', 'Affiliation': 'Nuffield Health Cheltenham Hospital, Cheltenham, UK.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Churn', 'Affiliation': 'Worcestershire Acute Hospitals NHS Trust, Worcester, UK.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Cleator', 'Affiliation': 'Imperial Healthcare NHS Trust, London, UK.'}, {'ForeName': 'Charlotte E', 'Initials': 'CE', 'LastName': 'Coles', 'Affiliation': 'University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Goodman', 'Affiliation': 'Royal Devon and Exeter NHS Foundation Trust, Exeter, UK; Torbay Hospital NHS Foundation Trust, Torquay, UK.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Harnett', 'Affiliation': 'Norfolk and Norwich University Hospital, Norwich, UK.'}, {'ForeName': 'Penelope', 'Initials': 'P', 'LastName': 'Hopwood', 'Affiliation': 'Clinical Trials and Statistics Unit, The Institute of Cancer Research, Sutton, London, UK.'}, {'ForeName': 'Anna M', 'Initials': 'AM', 'LastName': 'Kirby', 'Affiliation': 'The Royal Marsden NHS Foundation Trust and The Institute of Cancer Research, London, UK.'}, {'ForeName': 'Cliona C', 'Initials': 'CC', 'LastName': 'Kirwan', 'Affiliation': 'University of Manchester, Manchester, UK.'}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Morris', 'Affiliation': ""Independent Cancer Patients' Voice, London, UK.""}, {'ForeName': 'Zohal', 'Initials': 'Z', 'LastName': 'Nabi', 'Affiliation': 'Mount Vernon Cancer Centre, Northwood, UK.'}, {'ForeName': 'Elinor', 'Initials': 'E', 'LastName': 'Sawyer', 'Affiliation': ""King's College London, London, UK.""}, {'ForeName': 'Navita', 'Initials': 'N', 'LastName': 'Somaiah', 'Affiliation': 'The Royal Marsden NHS Foundation Trust and The Institute of Cancer Research, London, UK.'}, {'ForeName': 'Liba', 'Initials': 'L', 'LastName': 'Stones', 'Affiliation': 'Clinical Trials and Statistics Unit, The Institute of Cancer Research, Sutton, London, UK.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Syndikus', 'Affiliation': 'Clatterbridge Cancer Centre, Bebington, Wirral, UK.'}, {'ForeName': 'Judith M', 'Initials': 'JM', 'LastName': 'Bliss', 'Affiliation': 'Clinical Trials and Statistics Unit, The Institute of Cancer Research, Sutton, London, UK.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Yarnold', 'Affiliation': 'The Royal Marsden NHS Foundation Trust and The Institute of Cancer Research, London, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Lancet (London, England)",['10.1016/S0140-6736(20)30932-6'] 1956,32468741,Pharmacokinetics and Safety of Two Voriconazole Formulations after Intravenous Infusion in Healthy Korean Volunteers.,"BACKGROUND Voriconazole, a triazole antifungal agent exhibits broad-spectrum antifungal activity. It is used to treat severe, invasive fungal infections, including invasive aspergillosis and candidemia. The aim of this study was to assess the pharmacokinetic equivalence of a test formulation (Vorico® Injection) and reference formulation (Vfend® IV) of voriconazole. MATERIALS AND METHODS This was a randomized, open-label, single-dose, three-group, two-treatment, two-sequence, two-period, crossover phase I trial with 7-day washout periods (ClinicalTrials.gov identifier NCT02631954). Twenty-four healthy Korean male subjects were recruited. In each group, eight subjects were randomized in a 1:1 manner to receive a single dose of 200 mg test or reference formulation intravenously over 1.5 h. Blood samples were collected over 24 h post-dose, and plasma drug concentrations were determined by liquid chromatography-tandem mass spectrometry. Pharmacokinetic parameters were determined using a non-compartmental analysis, and safety was evaluated. RESULTS Twenty-three subjects completed the study. The geometric mean ratio (90% confidence interval) of the test formulation to reference formulation was 0.9570 (0.8178 - 1.1199) for the maximum plasma concentration (C max ) and 1.0720 (1.0262 - 1.1198) for the area under the concentration-time curve from dosing to the last quantifiable concentration (AUC last ). The mean plasma concentration-time profiles, pharmacokinetic parameters, and safety were comparable between the two formulations. CONCLUSION Equivalent pharmacokinetic characteristics that satisfied the criteria of bioequivalence and similar safety profiles were observed for both test and reference formulations of voriconazole.",2020,The geometric mean ratio (90% confidence interval) of the test formulation to reference formulation was 0.9570,"['Twenty-three subjects completed the study', 'Twenty-four healthy Korean male subjects were recruited', 'Healthy Korean Volunteers']","['Two Voriconazole Formulations', 'test formulation (Vorico® Injection) and reference formulation (Vfend® IV) of voriconazole']","['geometric mean ratio', 'maximum plasma concentration (C max ', 'mean plasma concentration-time profiles, pharmacokinetic parameters, and safety', 'pharmacokinetic equivalence']","[{'cui': 'C0450348', 'cui_str': '23'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C0393080', 'cui_str': 'voriconazole'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C1136812', 'cui_str': 'Vfend'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",8.0,0.088423,The geometric mean ratio (90% confidence interval) of the test formulation to reference formulation was 0.9570,"[{'ForeName': 'Sang Heon', 'Initials': 'SH', 'LastName': 'Cho', 'Affiliation': 'Department of Clinical Pharmacology, Inha University Hospital, Inha University School of Medicine, Incheon, Korea. shcho123@inha.ac.kr.'}, {'ForeName': 'Cheol Woo', 'Initials': 'CW', 'LastName': 'Kim', 'Affiliation': 'Department of Clinical Pharmacology, Inha University Hospital, Inha University School of Medicine, Incheon, Korea.'}, {'ForeName': 'Moon Suk', 'Initials': 'MS', 'LastName': 'Nam', 'Affiliation': 'Department of Clinical Pharmacology, Inha University Hospital, Inha University School of Medicine, Incheon, Korea.'}]",Infection & chemotherapy,['10.3947/ic.2020.52.2.204'] 1957,32469398,Effect of lean red meat combined with a multicomponent exercise program on muscle and cognitive function in older adults: a 6-month randomized controlled trial.,"BACKGROUND Exercise and increased dietary protein have been linked to improved muscle and cognitive health, but the combination may be more effective. OBJECTIVE In this study performed in community-dwelling older adults undergoing a 3-d/wk resistance-based exercise training program, we investigated whether those who consumed lean red meat compared to carbohydrates on the 3 training days per wk would experience greater exercise-induced improvements in total body and leg lean mass (LM), muscle strength, and executive function (multiple primary outcomes), as well as muscle size and density, functional performance, cognition, inflammatory and neurotrophic markers, blood pressure, and lipid concentrations. DESIGN In a 24-wk, 2-arm parallel randomized controlled trial, 154 adults aged ≥65 y participated in a multicomponent 3-d/wk resistance-based exercise program with random allocation to either a lean red meat group (two 80-g servings of cooked red meat), the exercise plus lean red meat (Ex + Meat) group (n = 77) or a control group receiving carbohydrates in the form of one-half cup (approximately 225 g cooked weight) of rice or pasta or 1 medium potato, the exercise plus carbohydrate control (C + Ex) group (n = 77), on the training days. RESULTS Exercise-induced improvements (mean within group changes) did not significantly differ between groups for the primary outcomes of total body LM (0.6 to 0.8 kg), leg LM (0.1 to 0.2 kg), thigh muscle cross-sectional area (3.7% to 4.9%), leg and back muscle strength (26% to 40%), and executive function (z-score SD: 0.33 to 0.39), nor the secondary outcomes of global cognition function (0.17 to 0.23 SD), fat mass (-0.65 to -0.75 kg), physical function measures (sit-to-stand, both 15%; 4-square step test, 2% to 7%), or systolic blood pressure (-3.2 to -4.1 mm Hg). The Ex + Meat group experienced greater improvements than the C + Ex in arm LM (0.07 kg; 95% CI: 0.01, 0.14; P = 0.029), gait speed (0.05 m/s; 95% CI: 0.00, 0.11; P = 0.042), muscle density (1.0%; 95% CI: 0.2, 1.9; P = 0.015), and appendicular LM in the per-protocol analysis (0.21 kg; 95% CI: 0.02, 0.40; P = 0.03). The C + Ex group had greater net improvements in working memory/learning after 12 wk (SD: 0.24; 95% CI: 0.05, 0.43; P = 0.011) and 24 wk (SD: 0.27; 95% CI: 0.06, 0.49; P = 0.007). Inflammatory and neurotrophic markers did not change in either group. CONCLUSION In healthy community-dwelling older adults undertaking resistance-based exercise training 3-d/wk, participants who consumed lean red meat in line with current Australian dietary recommendations did not experience any significant additional benefits in the primary outcome measures of muscle mass, strength, or cognitive function compared to participants consuming carbohydrates.This trial is registered with the Australian and New Zealand Clinical Trials Registry as ACTRN12613001153707.",2020,"The C + Ex group had greater net improvements in working memory/learning after 12 wk (SD: 0.24; 95% CI: 0.05, 0.43; P = 0.011) and 24 wk (SD: 0.27; 95% CI: 0.06, 0.49; P = 0.007).","['healthy community-dwelling older adults undertaking', 'community-dwelling older adults undergoing a', 'older adults', '154 adults aged ≥65 y participated in a']","['lean red meat combined with a multicomponent exercise program', '3-d/wk resistance-based exercise training program', 'multicomponent 3-d/wk resistance-based exercise program with random allocation to either a lean red meat group (two 80-g servings of cooked red meat), the exercise plus lean red meat (Ex +\xa0Meat) group (n = 77) or a control group receiving carbohydrates in the form of one-half cup (approximately 225 g cooked weight) of rice or pasta or 1 medium potato, the exercise plus carbohydrate control (C\xa0+\xa0Ex', 'resistance-based exercise training 3-d/wk, participants who consumed lean red meat in line with current Australian dietary recommendations']","['muscle and cognitive function', 'muscle density', 'muscle mass, strength, or cognitive function', 'Inflammatory and neurotrophic markers', 'thigh muscle cross-sectional area', 'gait speed', 'leg and back muscle strength', 'executive function', 'total body LM', 'working memory/learning', 'fat mass', 'physical function measures', 'total body and leg lean mass (LM), muscle strength, and executive function (multiple primary outcomes), as well as muscle size and density, functional performance, cognition, inflammatory and neurotrophic markers, blood pressure, and lipid concentrations', 'global cognition function', 'leg LM', 'systolic blood pressure', 'appendicular LM']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C5191279', 'cui_str': '154'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0452848', 'cui_str': 'Red meat'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0450363', 'cui_str': 'Three-dimensional'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0335326', 'cui_str': 'Cookery'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0025017', 'cui_str': 'Meat'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0220647', 'cui_str': 'Carcinoma of unknown primary'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C4517652', 'cui_str': '225'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0035567', 'cui_str': 'Rice'}, {'cui': 'C0452694', 'cui_str': 'Pasta'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0032846', 'cui_str': 'Potato'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}]","[{'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0240417', 'cui_str': 'Form of muscle'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0224416', 'cui_str': 'Skeletal muscle structure of thigh'}, {'cui': 'C0010362', 'cui_str': 'Cross Sectional Analysis'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0224334', 'cui_str': 'Skeletal muscle structure of back'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0424678', 'cui_str': 'Lean body mass'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}]",154.0,0.167933,"The C + Ex group had greater net improvements in working memory/learning after 12 wk (SD: 0.24; 95% CI: 0.05, 0.43; P = 0.011) and 24 wk (SD: 0.27; 95% CI: 0.06, 0.49; P = 0.007).","[{'ForeName': 'Melissa B', 'Initials': 'MB', 'LastName': 'Formica', 'Affiliation': 'Institute for Physical Activity and Nutrition (IPAN), School of Exercise and Nutrition Sciences, Deakin University, Melbourne, Australia.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Gianoudis', 'Affiliation': 'Institute for Physical Activity and Nutrition (IPAN), School of Exercise and Nutrition Sciences, Deakin University, Melbourne, Australia.'}, {'ForeName': 'Caryl A', 'Initials': 'CA', 'LastName': 'Nowson', 'Affiliation': 'Institute for Physical Activity and Nutrition (IPAN), School of Exercise and Nutrition Sciences, Deakin University, Melbourne, Australia.'}, {'ForeName': 'Stella L', 'Initials': 'SL', 'LastName': ""O'Connell"", 'Affiliation': 'Institute for Physical Activity and Nutrition (IPAN), School of Exercise and Nutrition Sciences, Deakin University, Melbourne, Australia.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Milte', 'Affiliation': 'Institute for Physical Activity and Nutrition (IPAN), School of Exercise and Nutrition Sciences, Deakin University, Melbourne, Australia.'}, {'ForeName': 'Kathryn A', 'Initials': 'KA', 'LastName': 'Ellis', 'Affiliation': 'Neurodegeneration Division, The Florey Institute, Academic Unit for Psychiatry of Old Age, Department of Psychiatry, The University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Robin M', 'Initials': 'RM', 'LastName': 'Daly', 'Affiliation': 'Institute for Physical Activity and Nutrition (IPAN), School of Exercise and Nutrition Sciences, Deakin University, Melbourne, Australia.'}]",The American journal of clinical nutrition,['10.1093/ajcn/nqaa104'] 1958,32475312,"Modest Sodium Reduction Increases Circulating Short-Chain Fatty Acids in Untreated Hypertensives: A Randomized, Double-Blind, Placebo-Controlled Trial.","High-sodium diet may modulate the gut microbiome. Given the circulating short-chain fatty acids (SCFAs) are microbial in origin, we tested the hypothesis that the modest sodium reduction would alter circulating SCFA concentrations among untreated hypertensives, and the changes would be associated with reduced blood pressure and improved cardiovascular phenotypes. A total of 145 participants (42% blacks, 19% Asian, and 34% females) were included from a randomized, double-blind, placebo-controlled cross-over trial of sodium reduction with slow sodium or placebo tablets, each for 6 weeks. Targeted circulating SCFA profiling was performed in paired serum samples, which were collected at the end of each period, so as all outcome measures. Sodium reduction increased all 8 SCFAs, among which the increases in 2-methylbutyrate, butyrate, hexanoate, isobutyrate, and valerate were statistically significant ( P s<0.05). Also, increased SCFAs were associated with decreased blood pressure and improved arterial compliance. There were significant sex differences of SCFAs in response to sodium reduction ( P s<0.05). When stratified by sex, the increases in butyrate, hexanoate, isobutyrate, isovalerate, and valerate were significant in females only ( P s<0.05), not in males ( P s>0.05). In females, changes in isobutyrate, isovalerate, and 2-methylbutyrate were inversely associated with reduced blood pressures ( P s<0.05). Increased valerate was associated with decreased carotid-femoral pulse wave velocity ( P =0.040). Our results show that dietary sodium reduction increases circulating SCFAs, supporting that dietary sodium may influence the gut microbiome in humans. There is a sex difference in SCFA response to sodium reduction. Moreover, increased SCFAs are associated with decreased blood pressures and improved arterial compliance. Registration- URL: https://www.clinicaltrials.gov. Unique identifier: NCT00152074.",2020,Increased valerate was associated with decreased carotid-femoral pulse wave velocity ( P =0.040).,"['145 participants (42% blacks, 19% Asian, and 34% females', 'Untreated Hypertensives']","['placebo-controlled cross-over trial of sodium reduction with slow sodium or placebo tablets', 'Modest Sodium Reduction Increases Circulating Short-Chain Fatty Acids', 'Placebo', 'High-sodium diet']","['blood pressures and improved arterial compliance', 'Sodium reduction', 'SCFA response', 'blood pressures', '2-methylbutyrate, butyrate, hexanoate, isobutyrate, and valerate', 'circulating SCFA concentrations', 'blood pressure and improved cardiovascular phenotypes', 'carotid-femoral pulse wave velocity', 'blood pressure and improved arterial compliance', 'butyrate, hexanoate, isobutyrate, isovalerate, and valerate']","[{'cui': 'C4517577', 'cui_str': '145'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0150097', 'cui_str': 'Crossover Trials'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0015691', 'cui_str': 'Short chain fatty acid'}, {'cui': 'C0452340', 'cui_str': 'High sodium diet'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0015691', 'cui_str': 'Short chain fatty acid'}, {'cui': 'C0046367', 'cui_str': '2-methylbutyrate'}, {'cui': 'C0006521', 'cui_str': 'Butyrates'}, {'cui': 'C0121652', 'cui_str': 'hexanoate'}, {'cui': 'C0042280', 'cui_str': 'Pentanoates'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0031437', 'cui_str': 'Phenotype'}, {'cui': 'C5197774', 'cui_str': 'Carotid-Femoral Pulse Wave Velocities'}]",145.0,0.135264,Increased valerate was associated with decreased carotid-femoral pulse wave velocity ( P =0.040).,"[{'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'From the Department of Medicine, Georgia Prevention Institute, Medical College of Georgia, Augusta University, Augusta, GA (L.C., Y.D., Y.H., G.A.H., H.Z.).'}, {'ForeName': 'Feng J', 'Initials': 'FJ', 'LastName': 'He', 'Affiliation': 'Wolfson Institute of Preventive Medicine, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, United Kingdom (F.J.H., C.W.).'}, {'ForeName': 'Yanbin', 'Initials': 'Y', 'LastName': 'Dong', 'Affiliation': 'From the Department of Medicine, Georgia Prevention Institute, Medical College of Georgia, Augusta University, Augusta, GA (L.C., Y.D., Y.H., G.A.H., H.Z.).'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': 'From the Department of Medicine, Georgia Prevention Institute, Medical College of Georgia, Augusta University, Augusta, GA (L.C., Y.D., Y.H., G.A.H., H.Z.).'}, {'ForeName': 'Changqiong', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'Wolfson Institute of Preventive Medicine, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, United Kingdom (F.J.H., C.W.).'}, {'ForeName': 'Gregory A', 'Initials': 'GA', 'LastName': 'Harshfield', 'Affiliation': 'From the Department of Medicine, Georgia Prevention Institute, Medical College of Georgia, Augusta University, Augusta, GA (L.C., Y.D., Y.H., G.A.H., H.Z.).'}, {'ForeName': 'Haidong', 'Initials': 'H', 'LastName': 'Zhu', 'Affiliation': 'From the Department of Medicine, Georgia Prevention Institute, Medical College of Georgia, Augusta University, Augusta, GA (L.C., Y.D., Y.H., G.A.H., H.Z.).'}]","Hypertension (Dallas, Tex. : 1979)",['10.1161/HYPERTENSIONAHA.120.14800'] 1959,32476816,The correlation of cytokines and sensory hypersensitivity in mild dry eye patients characterized by symptoms outweighing signs.,"Purpose To explore the correlation of tear and conjunctival cytokines and sensory hypersensitivity in mild dry eye (MDE) patients characterized by symptoms outweighing signs (DESOS). Methods The subjects comprised 39 patients with MDE characterized by DESOS, 18 patients with common MDE (CMDE), and 15 healthy controls. The patients with DESOS were randomly subdivided into two groups; the C-DESOS group received artificial tears only, and the G-DESOS group received artificial tears and 0.1% fluorometholone eye drops three times a day. Symptoms were assessed using the Ocular Surface Disease Index (OSDI) and the Neuropathic Pain Symptoms Inventory modified for Eye (NPSI-E) questionnaire. Ocular examinations and in vivo confocal microscopy (IVCM) were also employed. Tear and conjunctival cytokines were measured using Multiplex or RT-PCR on Days 0, 7, and 30. The correlation between the expression of cytokines and hypersensitivity status was analyzed. Results Compared with the CMDE and control groups, the DESOS groups showed a significant increase in symptom scores and in the ratio of symptoms versus signs. IL-1 β, IL-2, IL-6, and TNF-α in tears and conjunctiva increased in the DESOS groups compared to the CMDE and control groups, indicating a high correlation with hypersensitivity status in the DESOS groups. Glucocorticoid treatment significantly decreased the level of cytokines in tears and conjunctiva in the G-DESOS group and subsequently ameliorated the symptoms. Conclusions Tear and conjunctival cytokines, including IL-1 β, IL-2, IL-6, and TNF-α, were correlated with sensory hypersensitivity status in the DESOS groups, suggesting they play an important role in the discordance of symptoms outweighing signs.",2020,"IL-1 β, IL-2, IL-6, and TNF-α in tears and conjunctiva increased in the DESOS groups compared to the CMDE and control groups, indicating a high correlation with hypersensitivity status in the DESOS groups.","['39 patients with MDE characterized by DESOS, 18 patients with common MDE (CMDE), and 15 healthy controls', 'patients with DESOS', 'mild dry eye (MDE) patients characterized by symptoms outweighing signs (DESOS', 'mild dry eye patients characterized by symptoms outweighing signs']","['CMDE', 'Glucocorticoid', 'vivo confocal microscopy (IVCM', 'C-DESOS group received artificial tears only, and the G-DESOS group received artificial tears and 0.1% fluorometholone eye drops three times a day']","['Conclusions\n\n\nTear and conjunctival cytokines, including IL-1 β, IL-2, IL-6, and TNF-α', 'IL-1 β, IL-2, IL-6, and TNF-α in tears and conjunctiva', 'Ocular Surface Disease Index (OSDI) and the Neuropathic Pain Symptoms Inventory modified for Eye (NPSI-E) questionnaire', 'expression of cytokines and hypersensitivity status', 'level of cytokines in tears and conjunctiva', 'Tear and conjunctival cytokines', 'cytokines and sensory hypersensitivity', 'symptom scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0013238', 'cui_str': 'Dry Eye Disease'}, {'cui': 'C3875152', 'cui_str': 'Characterizes'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0205214', 'cui_str': 'Common'}, {'cui': 'C0047006', 'cui_str': 'Methylenedioxyethylamphetamine'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205214', 'cui_str': 'Common'}, {'cui': 'C0047006', 'cui_str': 'Methylenedioxyethylamphetamine'}, {'cui': 'C0017710', 'cui_str': 'Glucocorticoid'}, {'cui': 'C0242842', 'cui_str': 'Confocal Microscopy'}, {'cui': 'C0013238', 'cui_str': 'Dry Eye Disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3875152', 'cui_str': 'Characterizes'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C2608262', 'cui_str': 'Artificial Tears'}, {'cui': 'C4517420', 'cui_str': '0.1'}, {'cui': 'C0016351', 'cui_str': 'Fluorometholone'}, {'cui': 'C0015399', 'cui_str': 'Eye drops'}, {'cui': 'C0556984', 'cui_str': 'Three times daily'}]","[{'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0021755', 'cui_str': 'Interleukin-1'}, {'cui': 'C0021756', 'cui_str': 'Interleukin-2'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0009758', 'cui_str': 'Conjunctival structure'}, {'cui': 'C1557335', 'cui_str': 'Ocular surface disease'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0027796', 'cui_str': 'Neuralgia'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",18.0,0.0262237,"IL-1 β, IL-2, IL-6, and TNF-α in tears and conjunctiva increased in the DESOS groups compared to the CMDE and control groups, indicating a high correlation with hypersensitivity status in the DESOS groups.","[{'ForeName': 'Bei', 'Initials': 'B', 'LastName': 'Li', 'Affiliation': '.The Third Affiliated Hospital, Guangzhou Medical University, 63 Duobao Road, Guangzhou, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Tian', 'Affiliation': '.The Third Affiliated Hospital, Guangzhou Medical University, 63 Duobao Road, Guangzhou, China.'}, {'ForeName': 'Shuangyong', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': '.The Third Affiliated Hospital, Guangzhou Medical University, 63 Duobao Road, Guangzhou, China.'}]",Molecular vision,[] 1960,32477208,Training Positive Rumination in Expressive Writing to Enhance Psychological Adjustment and Working Memory Updating for Maladaptive Ruminators.,"Rumination is associated with psychological adjustment and working memory (WM) capacity. Studies have shown that psychological interventions can reduce negative rumination and improve psychological adjustment and WM capacity. The present study investigated the effect of positive rumination training in expressive writing on psychological adjustment and WM updating capacity. Within an experimental design, positive rumination was manipulated for 10 participants who were maladaptive ruminators in an experiment using a 5-week training compared to the control group with nine participants. Results revealed significant enhancement of psychological adjustment and the response time (RT) of WM updating in the experimental group but not in the control group. The two groups did not show significant difference of all the variables in pretest. However, the experimental group showed significantly better outcomes than the control group in posttest. The results suggest that positive rumination training in expressive writing is effective and rumination has a causal influence on WM updating capacity.",2020,Results revealed significant enhancement of psychological adjustment and the response time (RT) of WM updating in the experimental group but not in the control group.,['10 participants who were maladaptive ruminators in an experiment using a 5-week training compared to the control group with nine participants'],['positive rumination training'],"['psychological adjustment and working memory (WM) capacity', 'psychological adjustment and the response time (RT) of WM updating', 'negative rumination and improve psychological adjustment and WM capacity']","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0154575', 'cui_str': 'Rumination disorder'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0557904', 'cui_str': 'Emotional adjustment'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0154575', 'cui_str': 'Rumination disorder'}, {'cui': 'C0184511', 'cui_str': 'Improved'}]",10.0,0.0192719,Results revealed significant enhancement of psychological adjustment and the response time (RT) of WM updating in the experimental group but not in the control group.,"[{'ForeName': 'Hongfei', 'Initials': 'H', 'LastName': 'Yang', 'Affiliation': 'Department of Psychology and Behavioral Sciences, Zhejiang University, Hangzhou, China.'}, {'ForeName': 'Huizhong', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Department of Psychology and Behavioral Sciences, Zhejiang University, Hangzhou, China.'}]",Frontiers in psychology,['10.3389/fpsyg.2020.00789'] 1961,32452896,Mis-estimation of coronary lesions and rectification by SYNTAX score feedback for coronary revascularization appropriateness.,"BACKGROUND Imprecise interpretation of coronary angiograms was reported and resulted in inappropriate revascularization. Synergy Between Percutaneous Coronary Intervention with Taxus and Cardiac Surgery (SYNTAX) score is a comprehensive system to evaluate the complexity of the overall lesions. We hypothesized that a real-time SYNTAX score feedback from image analysts may rectify the mis-estimation and improve revascularization appropriateness in patients with stable coronary artery disease (CAD). METHODS In this single-center, historical control study, patients with stable CAD with coronary lesion stenosis ≥50% were consecutively recruited. During the control period, SYNTAX scores were calculated by treating cardiologists. During the intervention period, SYNTAX scores were calculated by image analysts immediately after coronary angiography and were provided to cardiologists in real-time to aid decision-making. The primary outcome was revascularization deemed inappropriate by Chinese appropriate use criteria for coronary revascularization. RESULTS A total of 3245 patients were enrolled and assigned to the control group (08/2016-03/2017, n = 1525) or the intervention group (03/2017-09/2017, n = 1720). For SYNTAX score tertiles, 17.9% patients were overestimated and 4.3% were underestimated by cardiologists in the control group. After adjustment, inappropriate revascularization significantly decreased in the intervention group compared with the control group (adjusted odds ratio [OR]: 0.83; 95% confidence interval [CI]: 0.73-0.95; P = 0.007). Both inappropriate percutaneous coronary intervention (adjusted OR: 0.82; 95% CI: 0.74-0.92; P < 0.001) and percutaneous coronary intervention utilization (adjusted OR: 0.88; 95% CI: 0.79-0.98; P = 0.016) decreased significantly in the intervention group. There was no significant difference in 1-year adverse cardiac events between the control group and the intervention group. CONCLUSIONS Real-time SYNTAX score feedback significantly reduced inappropriate coronary revascularization in stable patients with CAD. CLINICAL TRIAL REGISTRATION Nos. NCT03068858 and NCT02880605; https://www.clinicaltrials.gov.",2020,Both inappropriate percutaneous coronary intervention (adjusted OR: 0.82; 95% CI: 0.74-0.92; P < 0.001) and percutaneous coronary intervention utilization (adjusted OR: 0.88; 95% CI: 0.79-0.98; P = 0.016) decreased significantly in the intervention group.,"['patients with stable coronary artery disease (CAD', 'stable patients with CAD', 'patients with stable CAD with coronary lesion stenosis ≥50% were consecutively recruited', '3245 patients were enrolled and assigned to the control group (08/2016-03/2017, n\u200a=\u200a1525) or the intervention group (03/2017-09/2017, n\u200a=\u200a1720']","['Real-time SYNTAX score feedback', 'Percutaneous Coronary Intervention with Taxus and Cardiac Surgery (SYNTAX) score']","['revascularization deemed inappropriate by Chinese appropriate use criteria for coronary revascularization', 'percutaneous coronary intervention utilization', 'inappropriate revascularization', 'inappropriate coronary revascularization', '1-year adverse cardiac events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0678234', 'cui_str': 'Form of stenosis'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517603', 'cui_str': '1720'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0330199', 'cui_str': 'Taxus'}, {'cui': 'C0018821', 'cui_str': 'Operation on heart'}]","[{'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C3542467', 'cui_str': 'Inappropriate'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0877341', 'cui_str': 'Coronary revascularisation'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}]",3245.0,0.104042,Both inappropriate percutaneous coronary intervention (adjusted OR: 0.82; 95% CI: 0.74-0.92; P < 0.001) and percutaneous coronary intervention utilization (adjusted OR: 0.88; 95% CI: 0.79-0.98; P = 0.016) decreased significantly in the intervention group.,"[{'ForeName': 'Shen', 'Initials': 'S', 'LastName': 'Lin', 'Affiliation': 'National Clinical Research Center of Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100032, China.'}, {'ForeName': 'Heng', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'National Clinical Research Center of Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100032, China.'}, {'ForeName': 'Si-Peng', 'Initials': 'SP', 'LastName': 'Chen', 'Affiliation': 'Department of Information Center, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100032, China.'}, {'ForeName': 'Chen-Fei', 'Initials': 'CF', 'LastName': 'Rao', 'Affiliation': 'National Clinical Research Center of Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100032, China.'}, {'ForeName': 'Fan', 'Initials': 'F', 'LastName': 'Wu', 'Affiliation': 'National Clinical Research Center of Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100032, China.'}, {'ForeName': 'Fa-Jun', 'Initials': 'FJ', 'LastName': 'Zhou', 'Affiliation': 'National Clinical Research Center of Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100032, China.'}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Biostatistics, Harvard T.H. Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Hong-Bing', 'Initials': 'HB', 'LastName': 'Yan', 'Affiliation': 'National Clinical Research Center of Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100032, China.'}, {'ForeName': 'Ke-Fei', 'Initials': 'KF', 'LastName': 'Dou', 'Affiliation': 'National Clinical Research Center of Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100032, China.'}, {'ForeName': 'Yong-Jian', 'Initials': 'YJ', 'LastName': 'Wu', 'Affiliation': 'National Clinical Research Center of Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100032, China.'}, {'ForeName': 'Yi-Da', 'Initials': 'YD', 'LastName': 'Tang', 'Affiliation': 'National Clinical Research Center of Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100032, China.'}, {'ForeName': 'Li-Hua', 'Initials': 'LH', 'LastName': 'Xie', 'Affiliation': 'National Clinical Research Center of Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100032, China.'}, {'ForeName': 'Chang-Dong', 'Initials': 'CD', 'LastName': 'Guan', 'Affiliation': 'National Clinical Research Center of Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100032, China.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Xu', 'Affiliation': 'National Clinical Research Center of Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100032, China.'}, {'ForeName': 'Zhe', 'Initials': 'Z', 'LastName': 'Zheng', 'Affiliation': 'National Clinical Research Center of Cardiovascular Diseases, State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100032, China.'}]",Chinese medical journal,['10.1097/CM9.0000000000000827'] 1962,32452208,"The Use of Recombinant Human Growth Hormone to Protect Against Muscle Weakness in Patients Undergoing Anterior Cruciate Ligament Reconstruction: A Pilot, Randomized Placebo-Controlled Trial.","BACKGROUND Anterior cruciate ligament (ACL) tears are common knee injuries. Despite undergoing extensive rehabilitation after ACL reconstruction (ACLR), many patients have persistent quadriceps muscle weakness that limits their successful return to play and are also at an increased risk of developing knee osteoarthritis (OA). Human growth hormone (HGH) has been shown to prevent muscle atrophy and weakness in various models of disuse and disease but has not been evaluated in patients undergoing ACLR. HYPOTHESIS Compared with placebo treatment, a 6-week perioperative treatment course of HGH would protect against muscle atrophy and weakness in patients undergoing ACLR. STUDY DESIGN Randomized controlled trial; Level of evidence, 2. METHODS A total of 19 male patients (aged 18-35 years) scheduled to undergo ACLR were randomly assigned to the placebo (n = 9) or HGH (n = 10) group. Patients began placebo or HGH treatment twice daily 1 week before surgery and continued through 5 weeks after surgery. Knee muscle strength and volume, patient-reported outcome scores, and circulating biomarkers were measured at several time points through 6 months after surgery. Mixed-effects models were used to evaluate differences between treatment groups and time points, and as this was a pilot study, significance was set at P < .10. The Cohen d was calculated to determine the effect size. RESULTS HGH was well-tolerated, and no differences in adverse events between the groups were observed. The HGH group had a 2.1-fold increase in circulating insulin-like growth factor 1 over the course of the treatment period ( P < .05; d = 2.93). The primary outcome measure was knee extension strength, and HGH treatment increased normalized peak isokinetic knee extension torque by 29% compared with the placebo group ( P = .05; d = 0.80). Matrix metalloproteinase-3 (MMP3), which was used as an indirect biomarker of cartilage degradation, was 36% lower in the HGH group ( P = .05; d = -1.34). HGH did not appear to be associated with changes in muscle volume or patient-reported outcome scores. CONCLUSION HGH improved quadriceps strength and reduced MMP3 levels in patients undergoing ACLR. On the basis of this pilot study, further trials to more comprehensively evaluate the ability of HGH to improve muscle function and potentially protect against OA in patients undergoing ACLR are warranted. REGISTRATION NCT02420353 ( ClinicalTrials.gov identifier).",2020,Matrix metalloproteinase-3,"['patients undergoing ACLR', 'Patients Undergoing Anterior Cruciate Ligament Reconstruction', 'Anterior cruciate ligament (ACL) tears are common knee injuries', '19 male patients (aged 18-35 years) scheduled to undergo ACLR', 'patients undergoing ACLR are warranted']","['extensive rehabilitation after ACL reconstruction (ACLR', 'Recombinant Human Growth Hormone', 'Placebo', 'Human growth hormone (HGH', 'Matrix metalloproteinase-3', 'placebo or HGH', 'HGH', 'placebo']","['quadriceps strength and reduced MMP3 levels', 'knee extension strength, and HGH treatment increased normalized peak isokinetic knee extension torque', 'adverse events', 'Knee muscle strength and volume, patient-reported outcome scores, and circulating biomarkers', 'circulating insulin-like growth factor']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0162596', 'cui_str': 'Cardiolipin antibody'}, {'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}, {'cui': 'C3178820', 'cui_str': 'Anterior Cruciate Ligament Reconstruction'}, {'cui': 'C0078960', 'cui_str': 'Structure of anterior cruciate ligament of knee joint'}, {'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C0205214', 'cui_str': 'Common'}, {'cui': 'C0022744', 'cui_str': 'Injury of knee'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}]","[{'cui': 'C0205231', 'cui_str': 'Extensive'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C3178820', 'cui_str': 'Anterior Cruciate Ligament Reconstruction'}, {'cui': 'C0162596', 'cui_str': 'Cardiolipin antibody'}, {'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}, {'cui': 'C0169964', 'cui_str': 'Somatropin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0164371', 'cui_str': 'Stromelysin 1'}]","[{'cui': 'C0164371', 'cui_str': 'Stromelysin 1'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0169964', 'cui_str': 'Somatropin'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0318082', 'cui_str': 'Ruminococcus torques'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0037657', 'cui_str': 'Somatomedin'}]",19.0,0.277985,Matrix metalloproteinase-3,"[{'ForeName': 'Christopher L', 'Initials': 'CL', 'LastName': 'Mendias', 'Affiliation': 'Hospital for Special Surgery, New York, New York, USA.'}, {'ForeName': 'Elizabeth R Sibilsky', 'Initials': 'ERS', 'LastName': 'Enselman', 'Affiliation': 'Department of Orthopaedic Surgery, University of Michigan Medical School, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Adam M', 'Initials': 'AM', 'LastName': 'Olszewski', 'Affiliation': 'Department of Orthopaedic Surgery, University of Michigan Medical School, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Jonathan P', 'Initials': 'JP', 'LastName': 'Gumucio', 'Affiliation': 'Department of Orthopaedic Surgery, University of Michigan Medical School, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Daniel L', 'Initials': 'DL', 'LastName': 'Edon', 'Affiliation': 'Hospital for Special Surgery, New York, New York, USA.'}, {'ForeName': 'Maxwell A', 'Initials': 'MA', 'LastName': 'Konnaris', 'Affiliation': 'Hospital for Special Surgery, New York, New York, USA.'}, {'ForeName': 'James E', 'Initials': 'JE', 'LastName': 'Carpenter', 'Affiliation': 'Department of Orthopaedic Surgery, University of Michigan Medical School, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Tariq M', 'Initials': 'TM', 'LastName': 'Awan', 'Affiliation': 'Department of Orthopaedic Surgery, University of Michigan Medical School, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Jon A', 'Initials': 'JA', 'LastName': 'Jacobson', 'Affiliation': 'Department of Radiology, University of Michigan Medical School, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Joel J', 'Initials': 'JJ', 'LastName': 'Gagnier', 'Affiliation': 'Department of Orthopaedic Surgery, University of Michigan Medical School, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Ariel L', 'Initials': 'AL', 'LastName': 'Barkan', 'Affiliation': 'Division of Metabolism, Endocrinology & Diabetes, Department of Internal Medicine, University of Michigan Medical School, Ann Arbor, Michigan, USA.'}, {'ForeName': 'Asheesh', 'Initials': 'A', 'LastName': 'Bedi', 'Affiliation': 'Department of Orthopaedic Surgery, University of Michigan Medical School, Ann Arbor, Michigan, USA.'}]",The American journal of sports medicine,['10.1177/0363546520920591'] 1963,32452275,A Novel Wearable Device for Motor Recovery of Hand Function in Chronic Stroke Survivors.,"Background. In monkey, reticulospinal connections to hand and forearm muscles are spontaneously strengthened following corticospinal lesions, likely contributing to recovery of function. In healthy humans, pairing auditory clicks with electrical stimulation of a muscle induces plastic changes in motor pathways (probably including the reticulospinal tract), with features reminiscent of spike-timing dependent plasticity. In this study, we tested whether pairing clicks with muscle stimulation could improve hand function in chronic stroke survivors. Methods. Clicks were delivered via a miniature earpiece; transcutaneous electrical stimuli at motor threshold targeted forearm extensor muscles. A wearable electronic device (WD) allowed patients to receive stimulation at home while performing normal daily activities. A total of 95 patients >6 months poststroke were randomized to 3 groups: WD with shock paired 12 ms before click; WD with clicks and shocks delivered independently; standard care. Those allocated to the device used it for at least 4 h/d, every day for 4 weeks. Upper-limb function was assessed at baseline and weeks 2, 4, and 8 using the Action Research Arm Test (ARAT), which has 4 subdomains (Grasp, Grip, Pinch, and Gross). Results. Severity across the 3 groups was comparable at baseline. Only the paired stimulation group showed significant improvement in total ARAT (median baseline: 7.5; week 8: 11.5; P = .019) and the Grasp subscore (median baseline: 1; week 8: 4; P = .004). Conclusion. A wearable device delivering paired clicks and shocks over 4 weeks can produce a small but significant improvement in upper-limb function in stroke survivors.",2020,A wearable device delivering paired clicks and shocks over 4 weeks can produce a small but significant improvement in upper-limb function in stroke survivors.,"['chronic stroke survivors', '95 patients >6 months poststroke', 'Chronic Stroke Survivors']","['pairing clicks with muscle stimulation', 'shock paired 12 ms before click; WD with clicks and shocks delivered independently; standard care']","['Upper-limb function', 'Grasp subscore', 'upper-limb function', 'total ARAT']","[{'cui': 'C3536593', 'cui_str': 'Chronic cerebrovascular accident'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0036974', 'cui_str': 'Shock'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0220843', 'cui_str': 'Grasp'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1264673', 'cui_str': 'Arbitrary rate'}]",95.0,0.0695364,A wearable device delivering paired clicks and shocks over 4 weeks can produce a small but significant improvement in upper-limb function in stroke survivors.,"[{'ForeName': 'Supriyo', 'Initials': 'S', 'LastName': 'Choudhury', 'Affiliation': 'Institute of Neurosciences, Kolkata, West Bengal, India.'}, {'ForeName': 'Ravi', 'Initials': 'R', 'LastName': 'Singh', 'Affiliation': 'Institute of Neurosciences, Kolkata, West Bengal, India.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Shobhana', 'Affiliation': 'Institute of Neurosciences, Kolkata, West Bengal, India.'}, {'ForeName': 'Dwaipayan', 'Initials': 'D', 'LastName': 'Sen', 'Affiliation': 'Institute of Neurosciences, Kolkata, West Bengal, India.'}, {'ForeName': 'Sidharth Shankar', 'Initials': 'SS', 'LastName': 'Anand', 'Affiliation': 'Institute of Neurosciences, Kolkata, West Bengal, India.'}, {'ForeName': 'Shantanu', 'Initials': 'S', 'LastName': 'Shubham', 'Affiliation': 'Institute of Neurosciences, Kolkata, West Bengal, India.'}, {'ForeName': 'Suparna', 'Initials': 'S', 'LastName': 'Gangopadhyay', 'Affiliation': 'Institute of Neurosciences, Kolkata, West Bengal, India.'}, {'ForeName': 'Mark R', 'Initials': 'MR', 'LastName': 'Baker', 'Affiliation': 'Newcastle University, Newcastle upon Tyne, Tyne and Wear, UK.'}, {'ForeName': 'Hrishikesh', 'Initials': 'H', 'LastName': 'Kumar', 'Affiliation': 'Institute of Neurosciences, Kolkata, West Bengal, India.'}, {'ForeName': 'Stuart N', 'Initials': 'SN', 'LastName': 'Baker', 'Affiliation': 'Newcastle University, Newcastle upon Tyne, Tyne and Wear, UK.'}]",Neurorehabilitation and neural repair,['10.1177/1545968320926162'] 1964,32461104,Tumor mutational burden and immune infiltration as independent predictors of response to neoadjuvant immune checkpoint inhibition in early TNBC in GeparNuevo.,"BACKGROUND The predictive value of tumor mutational burden (TMB), alone or in combination with an immune gene expression profile (GEP), for response to neoadjuvant therapy in early triple negative breast cancer (TNBC) is currently not known, either for immune checkpoint blockade (ICB) or conventional chemotherapy. PATIENTS AND METHODS We obtained both whole exome sequencing and RNA-Seq data from pretreatment samples of 149 TNBC of the recent neoadjuvant ICB trial, GeparNuevo. In a predefined analysis, we assessed the predictive value of TMB and a previously developed immune GEP for pathological complete remission (pCR). RESULTS Median TMB was 1.52 mut/Mb (range 0.02-7.65) and was significantly higher in patients with pCR (median 1.87 versus 1.39; P = 0.005). In multivariate analysis, odds ratios for pCR per mut/Mb were 2.06 [95% confidence intervals (CI) 1.33-3.20, P = 0.001] among all patients, 1.77 (95% CI 1.00-3.13, P = 0.049) in the durvalumab treatment arm, and 2.82 (95% CI 1.21-6.54, P = 0.016) in the placebo treatment arm, respectively. We also found that both continuous TMB and immune GEP (or tumor infiltrating lymphocytes) independently predicted pCR. When we stratified patients in groups based on the upper tertile of TMB and median GEP, we observed a pCR rate of 82% (95% CI 60% to 95%) in the group with both high TMB and GEP in contrast to only 28% (95% CI 16% to 43%) in the group with both low TMB and GEP. CONCLUSIONS TMB and immune GEP add independent value for pCR prediction. Our results recommend further analysis of TMB in combination with immune parameters to individually tailor therapies in breast cancer.",2020,"(95% CI 1.33-3.20, P=0.001) among all patients, 1.77 (95% CI 1.00-3.13, P=0.049) in the durvalumab treatment arm, and 2.82 (95% CI 1.21-6.54, P=0.016) in the placebo treatment arm, respectively.",['early triple negative breast cancer (TNBC'],[],"['pCR rate', 'Median TMB']","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C3539878', 'cui_str': 'Triple-negative breast cancer'}]",[],"[{'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}]",,0.160939,"(95% CI 1.33-3.20, P=0.001) among all patients, 1.77 (95% CI 1.00-3.13, P=0.049) in the durvalumab treatment arm, and 2.82 (95% CI 1.21-6.54, P=0.016) in the placebo treatment arm, respectively.","[{'ForeName': 'T', 'Initials': 'T', 'LastName': 'Karn', 'Affiliation': 'Goethe University, Frankfurt, Germany. Electronic address: t.karn@em.uni-frankfurt.de.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Denkert', 'Affiliation': 'University Hospital, Marburg, Germany.'}, {'ForeName': 'K E', 'Initials': 'KE', 'LastName': 'Weber', 'Affiliation': 'German Breast Group, Neu-Isenburg, Germany.'}, {'ForeName': 'U', 'Initials': 'U', 'LastName': 'Holtrich', 'Affiliation': 'Goethe University, Frankfurt, Germany.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Hanusch', 'Affiliation': 'Rotkreuzklinikum, Munich, Germany.'}, {'ForeName': 'B V', 'Initials': 'BV', 'LastName': 'Sinn', 'Affiliation': 'Charite University, Berlin, Germany.'}, {'ForeName': 'B W', 'Initials': 'BW', 'LastName': 'Higgs', 'Affiliation': 'AstraZeneca, Gaithersburg, USA.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Jank', 'Affiliation': 'University Hospital, Marburg, Germany.'}, {'ForeName': 'H P', 'Initials': 'HP', 'LastName': 'Sinn', 'Affiliation': 'University Hospital, Heidelberg, Germany.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Huober', 'Affiliation': 'University Hospital, Ulm, Germany.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Becker', 'Affiliation': 'Rotkreuzklinikum, Munich, Germany.'}, {'ForeName': 'J-U', 'Initials': 'JU', 'LastName': 'Blohmer', 'Affiliation': 'Charite University, Berlin, Germany.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Marmé', 'Affiliation': 'University Hospital, Heidelberg, Germany.'}, {'ForeName': 'W D', 'Initials': 'WD', 'LastName': 'Schmitt', 'Affiliation': 'Charite University, Berlin, Germany.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Wu', 'Affiliation': 'AstraZeneca, Gaithersburg, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'van Mackelenbergh', 'Affiliation': 'University Hospital, Kiel, Germany.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Müller', 'Affiliation': 'University Hospital, Hamburg, Germany.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Schem', 'Affiliation': 'Mammazentrum, Hamburg, Germany.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Stickeler', 'Affiliation': 'University Hospital, Aachen, Germany.'}, {'ForeName': 'P A', 'Initials': 'PA', 'LastName': 'Fasching', 'Affiliation': 'University Hospital Comprehensive Cancer Center, Friedrich-Alexander University, Erlangen, Germany.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Jackisch', 'Affiliation': 'Sana Klinikum, Offenbach, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Untch', 'Affiliation': 'Helios Kliniken Berlin-Buch, Berlin, Germany.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Schneeweiss', 'Affiliation': 'National Center of Tumor Diseases, Heidelberg, Germany.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Loibl', 'Affiliation': 'German Breast Group, Neu-Isenburg, Germany.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1016/j.annonc.2020.05.015'] 1965,32466446,Multicomponent Exercise Program Reduces Frailty and Inflammatory Biomarkers and Improves Physical Performance in Community-Dwelling Older Adults: A Randomized Controlled Trial.,"The efficacy of exercise to reverse frailty in the aging population has not been extensively investigated. This study aimed to investigate the effectiveness of a multicomponent exercise program (MCEP) on frailty, physical performance (handgrip strength, Berg Balance Scale (BBS), Timed Up and Go test (TUG), and VO 2 Max), blood biomarkers (Interleukin-6 (IL-6) and C-reactive protein (CRP)) in frail older adults. A randomized controlled trial using an allocation concealment method, included 64 older adults (77.78 ± 7.24 years), were divided into two parallel groups using block randomization: an MCEP group ( n = 32) and a control group ( n = 32). The combined center- and home-based MCEP training consisted of chair aerobic, resistance, and balance, which was carried out 3 days per week for 24 weeks. A mixed model repeated measure ANOVA demonstrated significant interaction effects of group x time for BBS, TUG and frailty scores ( p < 0.001). Additionally, the post-hoc analysis revealed that the MCEP group showed significantly improved BBS, TUG, and frailty scores ( p < 0.01), at both 12- and 24-weeks. When compared with controls at 12-weeks, the MCEP group decreased IL-6 and CRP levels ( p < 0.05). The combined center- and home-based MCEP were effective in reversing frailty to pre-frailty and improving physical performance especially balance in the older population.",2020,"A mixed model repeated measure ANOVA demonstrated significant interaction effects of group x time for BBS, TUG and frailty scores ( p < 0.001).","['frail older adults', 'Community-Dwelling Older Adults', '64 older adults (77.78 ± 7.24 years']","['Multicomponent Exercise Program', 'multicomponent exercise program (MCEP', 'MCEP', 'combined center- and home-based MCEP']","['BBS, TUG and frailty scores', 'Frailty and Inflammatory Biomarkers and Improves Physical Performance', 'frailty, physical performance (handgrip strength, Berg Balance Scale (BBS), Timed Up and Go test (TUG), and VO 2 Max), blood biomarkers (Interleukin-6 (IL-6) and C-reactive protein (CRP', 'BBS, TUG, and frailty scores', 'IL-6 and CRP levels']","[{'cui': 'C0079379', 'cui_str': 'Frail Older Adults'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0398791', 'cui_str': 'Microcephaly, normal intelligence and immunodeficiency'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0424594', 'cui_str': 'Frailty'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1998325', 'cui_str': 'Berg balance scale'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",64.0,0.0358322,"A mixed model repeated measure ANOVA demonstrated significant interaction effects of group x time for BBS, TUG and frailty scores ( p < 0.001).","[{'ForeName': 'Uratcha', 'Initials': 'U', 'LastName': 'Sadjapong', 'Affiliation': 'Department of Community Medicine, Faculty of Medicine, Chiang Mai University, Chiang Mai 50200, Thailand.'}, {'ForeName': 'Supachai', 'Initials': 'S', 'LastName': 'Yodkeeree', 'Affiliation': 'Department of Biochemistry, Faculty of Medicine, Chiang Mai University, Chiang Mai 50200, Thailand.'}, {'ForeName': 'Somporn', 'Initials': 'S', 'LastName': 'Sungkarat', 'Affiliation': 'Department of Physical Therapy, Faculty of Associated Medical Sciences, Chiang Mai University, Chiang Mai 50200, Thailand.'}, {'ForeName': 'Penprapa', 'Initials': 'P', 'LastName': 'Siviroj', 'Affiliation': 'Department of Community Medicine, Faculty of Medicine, Chiang Mai University, Chiang Mai 50200, Thailand.'}]",International journal of environmental research and public health,['10.3390/ijerph17113760'] 1966,32466496,Dance Fitness Classes Improve the Health-Related Quality of Life in Sedentary Women.,"This study aims to analyze the effect of two dance-focused and choreographic fitness classes on Health-Related Quality of Life (HRQoL) in sedentary worker women. Methods : 65 sedentary middle-aged worker women (38 ± 7.3 years old) completed a 16-week intervention randomly assigned to: (1) dance fitness group based on Zumba Fitness classes (DF group, n = 25)], (2) dance fitness + functional strength training group (DFFT group, n = 20), and (3) control group ( n = 20). HRQoL was assessed by the 36-Item Short-Form Health-Survey (SF-36), which evaluates 8 dimensions of health [General Health (GH), Physical Functioning (PF), Social Functioning (SF), Physical Role (PR), Emotional Role (ER), Bodily Pain (BP), Vitality (V), and Mental Health (MH)] scored from 0 (worst) to 100 (best health status). Results : The control group statistically differed from both exercise groups in PF and PR, and from the DF group in SF and MH showing a lower score. No statistical differences were observed between exercise groups post-intervention, except in V. DF group showed increases in GH, PF, SF, V, PR, and MH post-intervention. Conclusion : A 16-week dance fitness intervention based on Zumba Fitness classes generates notable improvements in a wide range of HRQoL dimensions in sedentary middle-aged worker women, especially in V, PR and MH dimensions.",2020,"The control group statistically differed from both exercise groups in PF and PR, and from the DF group in SF and MH showing a lower score.","['sedentary middle-aged worker women', '65 sedentary middle-aged worker women (38 ± 7.3 years old', 'Sedentary Women', 'sedentary worker women']","['dance fitness group based on Zumba Fitness classes (DF group, n = 25)], (2) dance fitness + functional strength training group (DFFT group, n = 20), and (3) control group']","['Health-Related Quality of Life (HRQoL', 'HRQoL', 'health [General Health (GH), Physical Functioning (PF), Social Functioning (SF), Physical Role (PR), Emotional Role (ER), Bodily Pain (BP), Vitality (V), and Mental Health (MH)] scored from 0 (worst) to 100 (best health status', 'GH, PF, SF, V, PR, and MH post-intervention', 'Health-Related Quality of Life', 'HRQoL dimensions']","[{'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0010963', 'cui_str': 'Dance'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0424575', 'cui_str': 'General body state finding'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0037395', 'cui_str': 'Social adjustment'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}]",65.0,0.0337697,"The control group statistically differed from both exercise groups in PF and PR, and from the DF group in SF and MH showing a lower score.","[{'ForeName': 'Yaira', 'Initials': 'Y', 'LastName': 'Barranco-Ruiz', 'Affiliation': 'Department of Physical Education and Sports, PROFITH ""PROmoting FITness and Health through physical activity"" Research Group, Sport and Health University Research Institute (iMUDS), Faculty of Education and Sport Sciences, University of Granada, 52071 Melilla, Spain.'}, {'ForeName': 'Susana', 'Initials': 'S', 'LastName': 'Paz-Viteri', 'Affiliation': 'Pedagogy School of Physical Activity and Sports, Faculty of Education Sciences, National University of Chimborazo, 060150 Riobamba, Ecuador.'}, {'ForeName': 'Emilio', 'Initials': 'E', 'LastName': 'Villa-González', 'Affiliation': 'Department of Physical Education and Sports, PROFITH ""PROmoting FITness and Health through physical activity"" Research Group, Sport and Health University Research Institute (iMUDS), Faculty of Education and Sport Sciences, University of Granada, 52071 Melilla, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph17113771'] 1967,32468892,Impact of immunogenicity on efficacy and tolerability of tumour necrosis factor inhibitors: pooled analysis of biosimilar studies in rheumatoid arthritis.,"OBJECTIVE SB4, SB2, and SB5 are biosimilars of etanercept (ETN), infliximab (INF), and adalimumab (ADA), respectively. This pooled analysis evaluated the immunogenicity of these treatments across three phase III randomized controlled trials of patients with rheumatoid arthritis (RA). METHODS Patients had to have at least one anti-drug antibody (ADAb) assessment up to the time of the primary endpoint from each study (week 24 in SB4 and SB5 studies; week 30 in SB2 study). The effect of ADAbs on American College of Rheumatology 20% (ACR20) response and the incidences of injection-site reactions (ISRs)/infusion-related reactions (IRRs) were evaluated. RESULTS The study included 1709 patients. The cumulative incidences of ADAbs were 30.3% in the all-treatments-combined group, 29.1% in the biosimilars combined group, and 31.5% in the reference products combined group. ACR20 response rates were significantly lower in ADAb-positive patients in the all-treatments-combined [odds ratio (95% confidence interval) 1.77 (1.37, 2.27), p < 0.0001], biosimilars combined [2.24 (1.53, 3.30), p < 0.0001], and reference products combined [1.49 (1.06, 2.09), p = 0.0225] groups. ADAb-positive patients also had a higher likelihood of developing ISRs/IRRs in the all-treatments-combined group [0.56 (0.31, 1.01), p = 0.0550], predominantly due to the results observed with SB2 + INF combined rather than with SB4 + ETN or SB5 + ADA combined. CONCLUSION In this pooled analysis, ADAbs were associated with reduced efficacy in patients with RA treated with biosimilars (SB4, SB2, and SB5) or their reference products (ETN, INF, and ADA). ADAbs were associated with an increased incidence of ISRs/IRRs in those treated with SB2 + INF. Clinical trial registration numbers: NCT01936181 (SB2 study), NCT01895309 (SB4 study), and NCT02167139 (SB5 study).",2020,"ACR20 response rates were significantly lower in ADAb-positive patients in the all-treatments-combined [odds ratio (95% confidence interval) 1.77 (1.37, 2.27), p < 0.0001], biosimilars combined [2.24 (1.53, 3.30), p < 0.0001], and reference products combined [1.49 (1.06, 2.09), p = 0.0225] groups.","['patients with rheumatoid arthritis (RA', 'Patients had to have at least one anti-drug antibody (ADAb) assessment up to the time of the primary endpoint from each study (week 24 in SB4 and SB5 studies; week 30 in SB2 study', '1709 patients', 'rheumatoid arthritis']","['tumour necrosis factor inhibitors', 'ADAbs']","['American College of Rheumatology 20% (ACR20) response and the incidences of injection-site reactions (ISRs)/infusion-related reactions (IRRs', 'efficacy and tolerability', 'incidence of ISRs/IRRs', 'likelihood of developing ISRs/IRRs', 'cumulative incidences of ADAbs', 'ACR20 response rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C1456820', 'cui_str': 'Tumor necrosis factor alpha'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0035452', 'cui_str': 'Rheumatology'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0151735', 'cui_str': 'Injection site reaction'}, {'cui': 'C0221208', 'cui_str': 'Injection site'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0033204', 'cui_str': 'Probability'}]",1709.0,0.148957,"ACR20 response rates were significantly lower in ADAb-positive patients in the all-treatments-combined [odds ratio (95% confidence interval) 1.77 (1.37, 2.27), p < 0.0001], biosimilars combined [2.24 (1.53, 3.30), p < 0.0001], and reference products combined [1.49 (1.06, 2.09), p = 0.0225] groups.","[{'ForeName': 'P', 'Initials': 'P', 'LastName': 'Emery', 'Affiliation': 'Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds, Chapel Allerton Hospital , Leeds, UK.'}, {'ForeName': 'C-H', 'Initials': 'CH', 'LastName': 'Suh', 'Affiliation': 'Department of Rheumatology, Ajou University School of Medicine , Suwon, Republic of Korea.'}, {'ForeName': 'M E', 'Initials': 'ME', 'LastName': 'Weinblatt', 'Affiliation': ""Division of Rheumatology, Immunology, and Allergy, Brigham and Women's Hospital , Boston, MA, USA.""}, {'ForeName': 'J S', 'Initials': 'JS', 'LastName': 'Smolen', 'Affiliation': 'Division of Rheumatology, Department of Medicine, Medical University of Vienna , Vienna, Austria.'}, {'ForeName': 'E C', 'Initials': 'EC', 'LastName': 'Keystone', 'Affiliation': 'Division of Rheumatology, Mount Sinai Hospital, University of Toronto , Toronto, ON, Canada.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Genovese', 'Affiliation': 'Division of Immunology and Rheumatology, Stanford University Medical Center, Stanford University School of Medicine , Palo Alto, CA, USA.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Vencovsky', 'Affiliation': 'Department of Rheumatology, Institute of Rheumatology , Prague, Czech Republic.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Kay', 'Affiliation': 'Division of Rheumatology, Department of Medicine, UMass Memorial Medical Center and University of Massachusetts Medical School , Worcester, MA, USA.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Hong', 'Affiliation': 'Samsung Bioepis Co. Ltd , Incheon, Republic of Korea.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Baek', 'Affiliation': 'Samsung Bioepis Co. Ltd , Incheon, Republic of Korea.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Ghil', 'Affiliation': 'Samsung Bioepis Co. Ltd , Incheon, Republic of Korea.'}]",Scandinavian journal of rheumatology,['10.1080/03009742.2020.1732458'] 1968,32471872,Olaparib Makes OS Gains in Ovarian Cancer.,"Olaparib has solidified its place as a standard maintenance therapy for patients with platinum-sensitive relapsed ovarian cancer who have BRCA mutations. In the phase III SOLO 2 trial, the drug extended overall survival by more than a year in these patients compared with a placebo.",2020,"In the phase III SOLO 2 trial, the drug extended overall survival by more than a year in these patients compared with a placebo.","['Ovarian Cancer', 'patients with platinum-sensitive relapsed ovarian cancer who have BRCA mutations']","['placebo', 'Olaparib']",['overall survival'],"[{'cui': 'C0919267', 'cui_str': 'Neoplasm of ovary'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032207', 'cui_str': 'Platinum'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0278689', 'cui_str': 'Recurrent ovarian cancer'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C2316164', 'cui_str': 'olaparib'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",,0.129422,"In the phase III SOLO 2 trial, the drug extended overall survival by more than a year in these patients compared with a placebo.",[],Cancer discovery,['10.1158/2159-8290.CD-NB2020-048'] 1969,32472628,Remote ischemic conditioning combined with intravenous thrombolysis for acute ischemic stroke.,"OBJECTIVE The objective of this study was to investigate the safety and efficacy of remote ischemic conditioning (RIC) combined with intravenous thrombolysis (IVT) in the treatment of acute ischemic stroke (AIS). METHODS Patients with AIS who underwent IVT were enrolled and 1:1 randomized to the RIC group and sham-RIC group in this study. RIC (or sham-RIC) was performed twice within 6-24 h of IVT. The subjects in the two groups were followed up for 90 days. The safety outcome included the ratio of hemorrhagic transformation (HT), adverse events during the follow-up, blood pressure within the first 24 h after IVT, and laboratory tests 24 h after IVT. The efficacy outcome included the modified Rankin Scale (mRS) score, National Institute of Health Stroke Scale (NIHSS) score during the follow-up, and level of high-sensitivity C-reactive protein (hs-CRP) tested 24 h after IVT. RESULTS Forty-nine patients (24 in the RIC group and 25 in the sham-RIC group) were recruited. No significant difference was observed in the ratio of HT, adverse events, blood pressure, coagulation function or liver function between groups. In addition, there was no significant difference in mRS score and NIHSS score during the follow-up between groups. However, patients in the RIC group exhibited a significant lower level of hs-CRP compared with the control group (P = 0.048). INTERPRETATION RIC combined with IVT is safe in the treatment of AIS. The neuroprotective and anti-inflammatory effects of this therapy warrant further study on a larger scale.",2020,"No significant difference was observed in the ratio of HT, adverse events, blood pressure, coagulation function or liver function between groups.","['acute ischemic stroke', 'acute ischemic stroke (AIS', 'Patients with AIS who underwent', 'Forty-nine patients (24 in the RIC group and 25 in the sham-RIC group) were recruited']","['RIC (or sham-RIC', 'RIC group and sham-RIC', 'IVT', 'remote ischemic conditioning (RIC) combined with intravenous thrombolysis (IVT', 'Remote ischemic conditioning combined with intravenous thrombolysis']","['ratio of HT, adverse events, blood pressure, coagulation function or liver function', 'mRS score and NIHSS score', 'safety and efficacy', 'modified Rankin Scale (mRS) score, National Institute of Health Stroke Scale (NIHSS) score during the follow-up, and level of high-sensitivity C-reactive protein (hs-CRP', 'level of hs-CRP', 'ratio of hemorrhagic transformation (HT), adverse events during the follow-up, blood pressure within the first 24\xa0h after IVT, and laboratory tests 24\xa0h after IVT']","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0520997', 'cui_str': 'Thrombolysis'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0333275', 'cui_str': 'Hemorrhagic'}, {'cui': 'C3714584', 'cui_str': 'Transformation'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0005778', 'cui_str': 'Coagulation, Blood'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0232741', 'cui_str': 'Liver function'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0520997', 'cui_str': 'Thrombolysis'}, {'cui': 'C0022885', 'cui_str': 'Laboratory procedure'}]",,0.0585417,"No significant difference was observed in the ratio of HT, adverse events, blood pressure, coagulation function or liver function between groups.","[{'ForeName': 'Yao-De', 'Initials': 'YD', 'LastName': 'He', 'Affiliation': 'Department of Neurology, Stroke Center, The First Hospital of Jilin University, Chang Chun, Jilin, 130021, China.'}, {'ForeName': 'Zhen-Ni', 'Initials': 'ZN', 'LastName': 'Guo', 'Affiliation': 'Department of Neurology, Clinical Trial and Research Center for Stroke, The First Hospital of Jilin University, Chang Chun, Jilin, 130021, China.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Qin', 'Affiliation': 'Department of Neurology, Stroke Center, The First Hospital of Jilin University, Chang Chun, Jilin, 130021, China.'}, {'ForeName': 'Hang', 'Initials': 'H', 'LastName': 'Jin', 'Affiliation': 'Department of Neurology, Stroke Center, The First Hospital of Jilin University, Chang Chun, Jilin, 130021, China.'}, {'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Zhang', 'Affiliation': 'Department of Neurology, Clinical Trial and Research Center for Stroke, The First Hospital of Jilin University, Chang Chun, Jilin, 130021, China.'}, {'ForeName': 'Reziya', 'Initials': 'R', 'LastName': 'Abuduxukuer', 'Affiliation': 'Department of Neurology, Stroke Center, The First Hospital of Jilin University, Chang Chun, Jilin, 130021, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Department of Neurology, Stroke Center, The First Hospital of Jilin University, Chang Chun, Jilin, 130021, China.'}]",Annals of clinical and translational neurology,['10.1002/acn3.51063'] 1970,32472768,Population-level viral suppression among pregnant and postpartum women in a universal test and treat trial.,"OBJECTIVE(S) We sought to determine whether universal 'test and treat' (UTT) can achieve gains in viral suppression beyond universal antiretroviral treatment (ART) eligibility during pregnancy and postpartum, among women living with HIV. DESIGN A community cluster randomized trial. METHODS The SEARCH UTT trial compared an intervention of annual population testing and universal ART with a control of baseline population testing with ART by country standard, including ART eligibility for all pregnant/postpartum women, in 32 communities in Kenya and Uganda. When testing, women were asked about current pregnancy and live births over the prior year and, if HIV-infected, had their viral load measured. Between arms, we compared population-level viral suppression (HIV RNA <500 copies/ml) among all pregnant/postpartum HIV-infected women at study close (year 3). We also compared year-3 population-level viral suppression and predictors of viral suppression among all 15 to 45-year-old women by arm. RESULTS At baseline, 92 and 93% of 15 to 45-year-old women tested for HIV: HIV prevalence was 12.6 and 12.3%, in intervention and control communities, respectively. Among HIV-infected women self-reporting pregnancy/live birth, prevalence of viral suppression was 42 and 44% at baseline, and 81 and 76% (P = 0.02) at year 3, respectively. Among all 15 to 45-year-old HIV-infected women, year-3 population-level viral suppression was higher in intervention (77%) versus control (68%; P < 0.001). Pregnancy/live birth was a predictor of year-3 viral suppression in control (P = 0.016) but not intervention (P = 0.43). Younger age was a risk factor for nonsuppression in both arms. CONCLUSION The SEARCH intervention resulted in higher population viral suppression among pregnant/postpartum women than a control of baseline universal testing with ART eligibility for pregnant/postpartum women.",2020,Pregnancy/live birth was a predictor of year-3 viral suppression in control (P = 0.016) but not intervention (P = 0.43).,"['all pregnant/postpartum women, in 32 communities in Kenya and Uganda', 'pregnant and postpartum women in a universal test and treat trial', '15 to 45-year-old women by arm', 'women living with HIV']","[""universal 'test and treat' (UTT""]","['year-3 viral suppression', 'HIV: HIV prevalence', 'viral suppression', 'year-3 population-level viral suppression', 'Pregnancy/live birth', 'population viral suppression']","[{'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0032804', 'cui_str': 'Postpartum Women'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0022558', 'cui_str': 'Kenya'}, {'cui': 'C0041573', 'cui_str': 'Uganda'}, {'cui': 'C0175671', 'cui_str': 'Universal'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}]","[{'cui': 'C0175671', 'cui_str': 'Universal'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0481667', 'cui_str': 'Live birth'}]",,0.305022,Pregnancy/live birth was a predictor of year-3 viral suppression in control (P = 0.016) but not intervention (P = 0.43).,"[{'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Kabami', 'Affiliation': 'Department of Medicine, Makerere University College of Health Sciences.'}, {'ForeName': 'Laura B', 'Initials': 'LB', 'LastName': 'Balzer', 'Affiliation': 'University of Massachusetts, Amherst, Massachusetts, USA.'}, {'ForeName': 'Hachem', 'Initials': 'H', 'LastName': 'Saddiki', 'Affiliation': 'University of Massachusetts, Amherst, Massachusetts, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Ayieko', 'Affiliation': 'Kenya Medical Research Institute, Nairobi, Kenya.'}, {'ForeName': 'Dalsone', 'Initials': 'D', 'LastName': 'Kwarisiima', 'Affiliation': 'Infectious Diseases Research Collaboration, Kampala, Uganda.'}, {'ForeName': 'Mucunguzi', 'Initials': 'M', 'LastName': 'Atukunda', 'Affiliation': 'Infectious Diseases Research Collaboration, Kampala, Uganda.'}, {'ForeName': 'Edwin D', 'Initials': 'ED', 'LastName': 'Charlebois', 'Affiliation': 'University of California, San Francisco.'}, {'ForeName': 'Tamara D', 'Initials': 'TD', 'LastName': 'Clark', 'Affiliation': 'University of California, San Francisco.'}, {'ForeName': 'Catherine A', 'Initials': 'CA', 'LastName': 'Koss', 'Affiliation': 'University of California, San Francisco.'}, {'ForeName': 'Theodore', 'Initials': 'T', 'LastName': 'Ruel', 'Affiliation': 'University of California, San Francisco.'}, {'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Bukusi', 'Affiliation': 'Kenya Medical Research Institute, Nairobi, Kenya.'}, {'ForeName': 'Craig R', 'Initials': 'CR', 'LastName': 'Cohen', 'Affiliation': 'University of California, San Francisco.'}, {'ForeName': 'Phillipa', 'Initials': 'P', 'LastName': 'Musoke', 'Affiliation': 'Department of Medicine, Makerere University College of Health Sciences.'}, {'ForeName': 'Maya L', 'Initials': 'ML', 'LastName': 'Petersen', 'Affiliation': 'University of California, Berkeley, California, USA.'}, {'ForeName': 'Diane V', 'Initials': 'DV', 'LastName': 'Havlir', 'Affiliation': 'University of California, San Francisco.'}, {'ForeName': 'Moses R', 'Initials': 'MR', 'LastName': 'Kamya', 'Affiliation': 'Department of Medicine, Makerere University College of Health Sciences.'}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Chamie', 'Affiliation': 'University of California, San Francisco.'}]","AIDS (London, England)",['10.1097/QAD.0000000000002564'] 1971,32470486,"Ruxolitinib in treatment of severe coronavirus disease 2019 (COVID-19): A multicenter, single-blind, randomized controlled trial.","BACKGROUND Accumulating evidence proposed JAK inhibitors as therapeutic targets warranting rapid investigation. OBJECTIVE This study evaluated the efficacy and safety of ruxolitinib, a Janus-associated kinase (JAK1/2) inhibitor, for COVID-19. METHODS We conducted a prospective, multicenter, single-blind, randomized controlled phase II trial involving patients with severe COVID-19. RESULTS Forty-three patients were randomly assigned (1:1) to receive ruxolitinib plus SoC treatment (22 patients) or placebo based on SoC treatment (21 patients). After exclusion of 2 patients (1 ineligible, 1 consent withdrawn) from the ruxolitinib group, 20 patients in intervention group and 21 patients in control group were included in the study. Treatment with ruxolitinib plus SoC was not associated with significantly accelerated clinical improvement in severe patients with COVID-19, although ruxolitinib recipients had a numerically faster clinical improvement. Eighteen (90%) patients from the ruxolitinib group showed CT improvement at D 14 compared with 13 (61.9%) patients from the control group (P = 0.0495). Three patients in the control group died of respiratory failure, with 14.3% overall mortality at D 28 ; no patients died in the ruxolitinib group. Ruxolitinib was well tolerated with low toxicities and no new safety signals. Levels of 7 cytokines were significantly decreased in the ruxolitinib group in comparison to the control group. CONCLUSIONS Although no statistical difference was observed, ruxolitinib recipients had a numerically faster clinical improvement. Significant chest CT improvement, a faster recovery from lymphopenia and favorable side-effect profile in ruxolitinib group were encouraging and informative to future trials to test efficacy of ruxolitinib in a larger population. This trial is registered at www.chictr.org.cn as ChiCTR-OPN-2000029580.",2020,"Significant chest CT improvement, a faster recovery from lymphopenia and favorable side-effect profile in ruxolitinib group were encouraging and informative to future trials to test efficacy of ruxolitinib in a larger population.","['severe coronavirus disease 2019 (COVID-19', 'patients with severe COVID-19', 'Forty-three patients']","['ruxolitinib plus SoC', 'placebo based on SoC treatment', 'ruxolitinib plus SoC treatment']","['tolerated with low toxicities and no new safety signals', 'overall mortality', 'died of respiratory failure', 'CT improvement', 'Levels of 7 cytokines']","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0450368', 'cui_str': '43'}]","[{'cui': 'C2931926', 'cui_str': 'ruxolitinib'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1145670', 'cui_str': 'Respiratory failure'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}]",43.0,0.116984,"Significant chest CT improvement, a faster recovery from lymphopenia and favorable side-effect profile in ruxolitinib group were encouraging and informative to future trials to test efficacy of ruxolitinib in a larger population.","[{'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Cao', 'Affiliation': 'Department of Hematology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, No. 1095 Jiefang Avenue, Wuhan, Hubei 430030, China;; Clincal Trial and Research Center of Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei 430030, China.'}, {'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Wei', 'Affiliation': 'Department of Hematology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, No. 1095 Jiefang Avenue, Wuhan, Hubei 430030, China;; Clincal Trial and Research Center of Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei 430030, China.'}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Zou', 'Affiliation': 'Department of Hematology, Wuhan No. 1 Hospital, No. 215 Zhongshan Ave., Wuhan, 430022, China.'}, {'ForeName': 'Tiebin', 'Initials': 'T', 'LastName': 'Jiang', 'Affiliation': 'Hematology Department of The Third Xiangya Hospital Central South University, 410013, Changsha, China.'}, {'ForeName': 'Gaoxiang', 'Initials': 'G', 'LastName': 'Wang', 'Affiliation': 'Department of Hematology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, No. 1095 Jiefang Avenue, Wuhan, Hubei 430030, China;; Clincal Trial and Research Center of Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei 430030, China.'}, {'ForeName': 'Liting', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Department of Hematology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, No. 1095 Jiefang Avenue, Wuhan, Hubei 430030, China;; Clincal Trial and Research Center of Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei 430030, China.'}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Huang', 'Affiliation': 'Department of Hematology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, No. 1095 Jiefang Avenue, Wuhan, Hubei 430030, China;; Clincal Trial and Research Center of Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei 430030, China.'}, {'ForeName': 'Fankai', 'Initials': 'F', 'LastName': 'Meng', 'Affiliation': 'Department of Hematology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, No. 1095 Jiefang Avenue, Wuhan, Hubei 430030, China;; Clincal Trial and Research Center of Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei 430030, China.'}, {'ForeName': 'Lifang', 'Initials': 'L', 'LastName': 'Huang', 'Affiliation': 'Department of Hematology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, No. 1095 Jiefang Avenue, Wuhan, Hubei 430030, China;; Clincal Trial and Research Center of Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei 430030, China.'}, {'ForeName': 'Na', 'Initials': 'N', 'LastName': 'Wang', 'Affiliation': 'Department of Hematology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, No. 1095 Jiefang Avenue, Wuhan, Hubei 430030, China;; Clincal Trial and Research Center of Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei 430030, China.'}, {'ForeName': 'Xiaoxi', 'Initials': 'X', 'LastName': 'Zhou', 'Affiliation': 'Department of Hematology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, No. 1095 Jiefang Avenue, Wuhan, Hubei 430030, China;; Clincal Trial and Research Center of Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei 430030, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Luo', 'Affiliation': 'Department of Hematology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, No. 1095 Jiefang Avenue, Wuhan, Hubei 430030, China;; Clincal Trial and Research Center of Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei 430030, China.'}, {'ForeName': 'Zekai', 'Initials': 'Z', 'LastName': 'Mao', 'Affiliation': 'Department of Hematology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, No. 1095 Jiefang Avenue, Wuhan, Hubei 430030, China;; Clincal Trial and Research Center of Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei 430030, China.'}, {'ForeName': 'Xing', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Department of Hematology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, No. 1095 Jiefang Avenue, Wuhan, Hubei 430030, China;; Clincal Trial and Research Center of Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei 430030, China.'}, {'ForeName': 'Jungang', 'Initials': 'J', 'LastName': 'Xie', 'Affiliation': 'Department of Respiratory and Critical Care Medicine, Key Laboratory of Pulmonary Diseases of Health Ministry, Key Cite of National Clinical Research Center for Respiratory Disease, Tongji Hospital, Tongji Medical College Huazhong University of Science and Technology, No. 1095 Jie Fang Avenue, 430030, Wuhan, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Hematology Department of The Third Xiangya Hospital Central South University, 410013, Changsha, China.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Cheng', 'Affiliation': 'Department of Hematology, Wuhan No. 1 Hospital, No. 215 Zhongshan Ave., Wuhan, 430022, China.'}, {'ForeName': 'Jianping', 'Initials': 'J', 'LastName': 'Zhao', 'Affiliation': 'Department of Respiratory and Critical Care Medicine, Key Laboratory of Pulmonary Diseases of Health Ministry, Key Cite of National Clinical Research Center for Respiratory Disease, Tongji Hospital, Tongji Medical College Huazhong University of Science and Technology, No. 1095 Jie Fang Avenue, 430030, Wuhan, China.'}, {'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Huang', 'Affiliation': ""Divisions of Pathology and Experimental Hematology and Cancer Biology, Cincinnati Children's Hospital Medical Center, 3333 Burnet Avenue, Room S7.224, Cincinnati, Ohio, USA.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'Department of Neurology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, No. 1095 Jiefang Avenue, Wuhan 430030, Hubei, China.'}, {'ForeName': 'Jianfeng', 'Initials': 'J', 'LastName': 'Zhou', 'Affiliation': 'Department of Hematology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, No. 1095 Jiefang Avenue, Wuhan, Hubei 430030, China;; Clincal Trial and Research Center of Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei 430030, China;. Electronic address: jfzhou@tjh.tjmu.edu.cn.'}]",The Journal of allergy and clinical immunology,['10.1016/j.jaci.2020.05.019'] 1972,32473556,Functional training with blood occlusion influences muscle quality indices in older adults.,"OBJECTIVES This study aimed to determine if functional training with blood flow restriction (BFR) has a greater effect on muscle quality indices and performance of older men when compared to functional training without BFR. MATERIALS AND METHODS Thirty men (67.7 ± 5.8 years) were randomly assigned to one of the following three groups: functional training (FT), functional training with blood flow restriction (FTBFR), and control (C). Participants in both experimental groups trained three sessions per week for six weeks. The training program included eleven body exercises, which were performed in 2-4 sets of 10 repetitions. FTBFR group wore pneumatic cuffs on their extremities that begun with 50 % of estimated arterial occlusion pressure and increased by 10 % every 2 weeks. Before and after the intervention period, subjects completed a series of tests to assess physical performances along with changes serum muscle quality indices. RESULTS A significant decrease in serum C-terminal Agrin Fragment (CAF) levels were observed in FT and FTBFR groups (p ≤ 0.05). In addition, the levels of CAF in FTBFR group was significantly lower compared to control group. Moreover, the circulatory levels of N-terminal propeptide type III collagen (P3NP) were reduced significantly in FT and C groups (p ≤ 0.05) but did not statistically differ from baseline in FTBFR group (p > 0.05). These changes were accompanied by significant improvements in dynamic strength, flexibility, static, and dynamic balance in both training groups (p ≤ 0.01). CONCLUSIONS The finding showed greater improvements in muscle quality indices and functional performance of older men when exercises performed with BFR.",2020,A significant decrease in serum C-terminal Agrin Fragment (CAF) levels were observed in FT and FTBFR groups (p ≤ 0.05).,"['Thirty men (67.7\u202f±\u202f5.8 years', 'older adults', 'older men']","['Functional training with blood occlusion', 'FTBFR group wore pneumatic cuffs', 'functional training with blood flow restriction (BFR', 'functional training (FT), functional training with blood flow restriction (FTBFR), and control (C']","['circulatory levels of N-terminal propeptide type III collagen (P3NP', 'dynamic strength, flexibility, static, and dynamic balance', 'serum C-terminal Agrin Fragment (CAF) levels', 'arterial occlusion pressure', 'muscle quality indices and functional performance', 'levels of CAF']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C4517796', 'cui_str': '5.8'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0441107', 'cui_str': 'Device cuff'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0005775', 'cui_str': 'Circulation, Blood'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0009332', 'cui_str': 'Collagen type III'}, {'cui': 'C0072054', 'cui_str': 'procollagen Type III-N-terminal peptide'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C4077009', 'cui_str': 'C-terminal agrin fragment'}, {'cui': 'C0264995', 'cui_str': 'Occlusion of artery'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205245', 'cui_str': 'Functional'}]",,0.0143913,A significant decrease in serum C-terminal Agrin Fragment (CAF) levels were observed in FT and FTBFR groups (p ≤ 0.05).,"[{'ForeName': 'Sima', 'Initials': 'S', 'LastName': 'Bigdeli', 'Affiliation': 'Department of Exercise Physiology, Faculty of Physical Education and Sports Science, Kharazmi University, Tehran, Iran.'}, {'ForeName': 'Mohammad Hasan', 'Initials': 'MH', 'LastName': 'Dehghaniyan', 'Affiliation': 'Department of Exercise Physiology, Faculty of Physical Education and Sports Science, Kharazmi University, Tehran, Iran.'}, {'ForeName': 'Sadegh', 'Initials': 'S', 'LastName': 'Amani-Shalamzari', 'Affiliation': 'Department of Exercise Physiology, Faculty of Physical Education and Sports Science, Kharazmi University, Tehran, Iran. Electronic address: amani_sadegh@khu.ac.ir.'}, {'ForeName': 'Hamid', 'Initials': 'H', 'LastName': 'Rajabi', 'Affiliation': 'Department of Exercise Physiology, Faculty of Physical Education and Sports Science, Kharazmi University, Tehran, Iran.'}, {'ForeName': 'Daniel E', 'Initials': 'DE', 'LastName': 'Gahreman', 'Affiliation': 'College of Health and Human Sciences, Charles Darwin University, Darwin, Northern Territory, Australia.'}]",Archives of gerontology and geriatrics,['10.1016/j.archger.2020.104110'] 1973,32473563,Exercise improves neurotrophins in multiple sclerosis independent of disability status.,"BACKGROUND To date, studies examining the effect of exercise on neurotrophic factors in MS are contradictory, and this may be explained, in part, by moderators such as disability status. To investigating the effect of a 12-week (3sessions/week) supervised multimodal exercise program on neurotrophic factors levels. METHODS Ninety four women with MS were randomly assigned into exercise or control conditions with randomization stratified by Expanded Disability Status Scale (EDSS) scores of low (EDSS< 4.5), moderate (4.5 ≤EDSS≤ 6), or high (EDSS≥ 6.5) disability. The exercise program comprised resistance, endurance, Pilates, balance and stretch exercises. Resting level of neurotrophic factors, aerobic capacity, one-repetition maximum, and physiological cost index (PCI) were evaluated before and after the intervention period. RESULTS Exercise training improved brain-derived neurotrophic factor (BDNF), neurotrophin (NT)-3, and NT-4/5 levels. The effect of exercise on NT-3 was dependent on disability status such that exercise groups with low and high disability had more pronounced changes compared with other condition. There were no exercise effects on ciliary neurotrophic factor (CNTF) and glial cell-derived neurotrophic factor (GDNF). Aerobic capacity and one-repetition maximum, but not PCI, were improved with exercise independent of disability status. CONCLUSIONS Exercise can stimulate neurotrophic production and secretion, and this is generally not influenced by disability status. Exercise training may be an adjuvant for disease-modifying therapy among people with MS, and its effect may not be moderated by disability status.",2020,There were no exercise effects on ciliary neurotrophic factor (CNTF) and glial cell-derived neurotrophic factor (GDNF).,['Ninety four women with MS'],"['Exercise', 'Exercise training', 'multimodal exercise program', 'exercise program comprised resistance, endurance, Pilates, balance and stretch exercises']","['Resting level of neurotrophic factors, aerobic capacity, one-repetition maximum, and physiological cost index (PCI', 'ciliary neurotrophic factor (CNTF) and glial cell-derived neurotrophic factor (GDNF', 'brain-derived neurotrophic factor (BDNF), neurotrophin (NT)-3, and NT-4/5 levels', 'Disability Status Scale (EDSS) scores', 'Aerobic capacity and one-repetition maximum']","[{'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0600080', 'cui_str': 'Stretching exercises'}]","[{'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0027754', 'cui_str': 'Nerve growth factor'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0207071', 'cui_str': 'Ciliary Neuronotrophic Factor'}, {'cui': 'C0027836', 'cui_str': 'Glia'}, {'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C0083735', 'cui_str': 'Neurotrophin 3'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0451246', 'cui_str': 'Kurtzke multiple sclerosis rating scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",94.0,0.0199456,There were no exercise effects on ciliary neurotrophic factor (CNTF) and glial cell-derived neurotrophic factor (GDNF).,"[{'ForeName': 'Ebrahim', 'Initials': 'E', 'LastName': 'Banitalebi', 'Affiliation': 'Department of Sport Sciences, Shahrekord University, Shahrekord, Iran. Electronic address: banitalebi@sku.ac.ir.'}, {'ForeName': 'Majid Mardaniyan', 'Initials': 'MM', 'LastName': 'Ghahfarrokhi', 'Affiliation': 'Department of Sport Sciences, Shahrekord University, Shahrekord, Iran.'}, {'ForeName': 'Raoof', 'Initials': 'R', 'LastName': 'Negaresh', 'Affiliation': 'Department of Physical Education & Sport Sciences, Faculty of Humanities, Tarbiat Modares University, Tehran, Iran.'}, {'ForeName': 'Abdolreza', 'Initials': 'A', 'LastName': 'Kazemi', 'Affiliation': 'Department of Sport Sciences, Vali-E-Asr University of Rafsanjan, Rafsanjan, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Faramarzi', 'Affiliation': 'Department of Sport Sciences, Shahrekord University, Shahrekord, Iran.'}, {'ForeName': 'Robert W', 'Initials': 'RW', 'LastName': 'Motl', 'Affiliation': 'Department of Physical Therapy, University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Zimmer', 'Affiliation': 'Department for Performance and Health, Institute for Sport and Sport Science, Technical University Dortmund, Germany.'}]",Multiple sclerosis and related disorders,['10.1016/j.msard.2020.102143'] 1974,32458286,A randomized controlled trial comparing right and left lateral decubitus starting position on outcomes in colonoscopy.,"BACKGROUND Patient positioning in colonoscopy has been proposed as a simple and inexpensive technique to increase luminal distention and improve navigation through the large bowel. We sought to determine if the right lateral (RL) starting position compared to the standard left lateral (LL) starting position could improve outcomes in colonoscopy. METHODS We conducted a randomized controlled trial of 185 patients who were undergoing an elective colonoscopy. Patients were randomized to either a right lateral decubitus starting position or a left lateral decubitus starting position and the primary outcome measure was cecal intubation time. Secondary outcome measures included cecal intubation rate, patient discomfort, and sedation dosage. All colonoscopists who had successfully completed a colonoscopy skills improvement course were included in the trial. A sample size was calculated prior to the start of the study and outcomes were analyzed using univariate and multiple regression analyses. RESULTS A total of 94 patients were randomized to RL starting position and 91 patients were randomized to LL starting position. No difference was found in time to cecal intubation comparing the RL starting position (542.6 s, SD 360.7 s) to LL starting position (497.85 s, SD 288.3 s) (p = 0.354). Variables associated with prolonged cecal intubation time included female gender, General Surgery specialty, less than 5 years of endoscopist experience, a high patient discomfort score, amount of water used, and number of position changes required to reach the cecum. There was no difference in any of the secondary outcome measures aside from the amount of midazolam used, with more midazolam used for patients starting in the right lateral decubitus position. CONCLUSION This study failed to show an association between cecal intubation time and patient position comparing right and left lateral starting position.",2020,"No difference was found in time to cecal intubation comparing the RL starting position (542.6 s, SD 360.7 s) to LL starting position (497.85 s, SD 288.3 s)","['94 patients', '185 patients who were undergoing an elective colonoscopy', 'All colonoscopists who had successfully completed a colonoscopy skills improvement course were included in the trial']","['right and left lateral decubitus starting position', 'right lateral decubitus starting position or a left lateral decubitus starting position', 'midazolam']","['time to cecal intubation', 'prolonged cecal intubation time included female gender, General Surgery specialty, less than 5\xa0years of endoscopist experience, a high patient discomfort score, amount of water used, and number of position changes required to reach the cecum', 'cecal intubation time', 'cecal intubation rate, patient discomfort, and sedation dosage']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517617', 'cui_str': '185'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0009378', 'cui_str': 'Colonoscopy'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0444379', 'cui_str': 'Lateral decubitus position'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C0559228', 'cui_str': 'Right lateral decubitus position'}, {'cui': 'C0026056', 'cui_str': 'Midazolam'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0007531', 'cui_str': 'Cecum structure'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0086287', 'cui_str': 'Female'}, {'cui': 'C1274039', 'cui_str': 'General surgery'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0444793', 'cui_str': 'Position change'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]",185.0,0.163214,"No difference was found in time to cecal intubation comparing the RL starting position (542.6 s, SD 360.7 s) to LL starting position (497.85 s, SD 288.3 s)","[{'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Greene', 'Affiliation': ""Department of Surgery, Health Sciences Center, Memorial University of Newfoundland, Room H-1373, 300 Prince Philip Drive, St. John's, NL, A1B3V6, Canada.""}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Borgoankar', 'Affiliation': ""Department of Medicine, Memorial University of Newfoundland, St. John's, NL, Canada.""}, {'ForeName': 'Kathy', 'Initials': 'K', 'LastName': 'Hodgkinson', 'Affiliation': ""Faculty of Medicine, Memorial University of Newfoundland, St. John's, NL, Canada.""}, {'ForeName': 'Chantae', 'Initials': 'C', 'LastName': 'Garland', 'Affiliation': ""Faculty of Medicine, Memorial University of Newfoundland, St. John's, NL, Canada.""}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Bacque', 'Affiliation': ""Department of Surgery, Health Sciences Center, Memorial University of Newfoundland, Room H-1373, 300 Prince Philip Drive, St. John's, NL, A1B3V6, Canada.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Pace', 'Affiliation': ""Department of Surgery, Health Sciences Center, Memorial University of Newfoundland, Room H-1373, 300 Prince Philip Drive, St. John's, NL, A1B3V6, Canada. dpace@mun.ca.""}]",Surgical endoscopy,['10.1007/s00464-020-07661-x'] 1975,32462746,Impact of the sexual abstinence period on the production of seminal reactive oxygen species in patients undergoing intrauterine insemination: A randomized trial.,"AIM To evaluate whether the duration of sexual abstinence has impact on oxidative stress in semen samples. METHODS Oxidative reaction was tested for different levels of reactive oxygen species (ROS) by nitro blue tetrazolium assay in 90 patients with the diagnosis of unexplained or male factor infertility that were grouped into 3 groups as 0-2 (group 1), 3-4 (group 2) and >4 days (group 3) of duration of sexual abstinence. Subsequently, the remaining semen was prepared by gradient method for ovarian stimulation and intrauterine insemination (IUI) cycles to compare pregnancy rates in terms of different levels of ROS and different abstinence periods. RESULTS Increased staining pigment intensity was related to higher level of ROS in >4 days' group as compared to groups 0-2 and 3-4 days (70% vs 43.3% and 50%, P = 0.013 and P = 0.014, respectively). Pregnancy rates significantly decrease with prolonged abstinence period (26.7%, 16.7% and 6.7% in groups 1, 2 and 3, respectively, P = 0.039). Progressive motile sperm count after gradient method of sperm preparation for IUI was highest in 3-4 days of abstinence period than shorter and longer abstinence groups. CONCLUSION Longer duration of sexual abstinence causes higher oxidative stress and decreases pregnancy rates in IUI cycles.",2020,"Progressive motile sperm count after gradient method of sperm preparation for IUI was highest in 3-4 days of abstinence period than shorter and longer abstinence groups. ","['90 patients with the diagnosis of unexplained or male factor infertility', 'patients undergoing intrauterine insemination', 'semen samples']",['reactive oxygen species (ROS) by nitro blue tetrazolium assay'],"['staining pigment intensity', 'Progressive motile sperm count', 'oxidative stress', 'pregnancy rates', 'level of ROS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0021359', 'cui_str': 'Sterility'}, {'cui': 'C0546824', 'cui_str': 'Intrauterine artificial insemination'}, {'cui': 'C0444176', 'cui_str': 'Seminal fluid specimen'}]","[{'cui': 'C0162772', 'cui_str': 'Oxygen Species, Reactive'}, {'cui': 'C0430303', 'cui_str': 'Nitro Blue tetrazolium assay'}]","[{'cui': 'C0038128', 'cui_str': 'Stain'}, {'cui': 'C0031911', 'cui_str': 'Pigmentation'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0577264', 'cui_str': 'Sperm motile'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rates'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0162772', 'cui_str': 'Oxygen Species, Reactive'}]",90.0,0.203675,"Progressive motile sperm count after gradient method of sperm preparation for IUI was highest in 3-4 days of abstinence period than shorter and longer abstinence groups. ","[{'ForeName': 'Yaman', 'Initials': 'Y', 'LastName': 'Degirmenci', 'Affiliation': 'Department of Obstetrics and Gynecology, Gazi University School of Medicine, Ankara, Turkey.'}, {'ForeName': 'Erhan', 'Initials': 'E', 'LastName': 'Demirdag', 'Affiliation': 'Department of Obstetrics and Gynecology, Gazi University School of Medicine, Ankara, Turkey.'}, {'ForeName': 'Ismail', 'Initials': 'I', 'LastName': 'Guler', 'Affiliation': 'Department of Obstetrics and Gynecology, Gazi University School of Medicine, Ankara, Turkey.'}, {'ForeName': 'Sule', 'Initials': 'S', 'LastName': 'Yildiz', 'Affiliation': 'Department of Obstetrics and Gynecology, Koç University School of Medicine, Istanbul, Turkey.'}, {'ForeName': 'Mehmet', 'Initials': 'M', 'LastName': 'Erdem', 'Affiliation': 'Department of Obstetrics and Gynecology, Gazi University School of Medicine, Ankara, Turkey.'}, {'ForeName': 'Ahmet', 'Initials': 'A', 'LastName': 'Erdem', 'Affiliation': 'Department of Obstetrics and Gynecology, Gazi University School of Medicine, Ankara, Turkey.'}]",The journal of obstetrics and gynaecology research,['10.1111/jog.14308'] 1976,32463117,K ATP channels modulate cerebral blood flow and oxygen delivery during isocapnic hypoxia in humans.,"KEY POINTS ATP-sensitive K + (K ATP ) channels mediate hypoxia-induced cerebral vasodilatation and hyperperfusion in animals. We tested whether K ATP channels blockade affects the increase in human cerebral blood flow (CBF) and the maintenance of oxygen delivery (CDO 2 ) during hypoxia. Hypoxia-induced increases in the anterior circulation and total cerebral perfusion were attenuated under K ATP channels blockade affecting the relative changes of brain oxygen delivery. Therefore, in humans, K ATP channels activation modulates the vascular tone in the anterior circulation of the brain, contributing to CBF and CDO 2 responses to hypoxia. ABSTRACT ATP-sensitive K + (K ATP ) channels mediate hypoxia-induced cerebral vasodilatation and hyperperfusion in animals. We tested whether K ATP channels blockade affects the increase in cerebral blood flow (CBF) and the maintenance of oxygen delivery (CDO 2 ) during hypoxia in humans. Nine healthy men were exposed to 5-min trials of normoxia and isocapnic hypoxia (IHX, 10% O 2 ) before (BGB) and 3 h after glibenclamide ingestion (AGB). Mean arterial pressure (MAP), arterial saturation ( S a O 2 ), partial pressure of oxygen ( P a O 2 ) and carbon dioxide ( P aC O 2 ), internal carotid artery blood flow (ICABF), vertebral artery blood flow (VABF), total (t)CBF (Doppler ultrasound) and CDO 2 were quantified during the trials. IHX provoked similar reductions in S a O 2 and P a O 2 , while MAP was not affected by oxygen desaturation or K ATP blockade. A smaller increase in ICABF (ΔBGB: 36 ± 23 vs. ΔAGB 11 ± 18%, p = 0.019) but not in VABF (∆BGB 26 ± 21 vs. ∆AGB 27 ± 27%, p = 0.893) was observed during the hypoxic trial under K ATP channels blockade. Thus, IHX-induced increases in tCBF (∆BGB 32 ± 19 vs. ∆AGB 14 ± 13%, p = 0.012) and CDO 2 relative changes (∆BGB 7 ± 13 vs. ∆AGB -6 ± 14%, p = 0.048) were attenuated during the AGB hypoxic trial. In a separate protocol, 6 healthy men (5 from protocol 1) underwent a 5-min exposure to normoxia and IHX before and 3 h after placebo (5 mg of cornstarch) ingestion. IHX reduced S a O 2 and P a O 2 , but placebo did not affect the ICABF, VABF, tCBF, or CDO 2 responses. Therefore, in humans, K ATP channels activation modulates vascular tone in the anterior rather than the posterior circulation of the brain, contributing to tCBF and CDO 2 responses to hypoxia.",2020,"IHX reduced SaO 2 and PaO 2 , but placebo did not affect ICABF, VABF, tCBF, or CDO 2 responses.","['6\xa0healthy men (5 from protocol 1) underwent', 'Nine healthy men', 'humans']","['normoxia and isocapnic hypoxia (IHX, 10% O 2 ) before (BGB) and 3\xa0h after glibenclamide ingestion (AGB', 'IHX', 'KATP channels blockade', '5-min exposure to normoxia and IHX before and 3\xa0h after placebo (5\xa0mg of cornstarch) ingestion', 'KATP channels', 'placebo']","['anterior circulation and total cerebral perfusion', 'ICABF', 'human cerebral blood flow (CBF', 'tCBF', 'Mean arterial pressure (MAP), arterial saturation (SaO 2 ), oxygen (PaO 2 ) and carbon dioxide (PaCO 2 ) partial pressure, internal carotid artery blood flow (ICABF), vertebral artery blood flow (VABF), total (t)CBF (Doppler Ultrasound) and CDO 2', 'cerebral blood flow (CBF', 'cerebral blood flow and oxygen delivery', 'ICABF, VABF, tCBF, or CDO 2 responses']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}]","[{'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0041119', 'cui_str': 'Tritium'}, {'cui': 'C0017628', 'cui_str': 'Glyburide'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C1955862', 'cui_str': 'ATP-Sensitive Potassium Channels'}, {'cui': 'C0332206', 'cui_str': 'Blocking'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1384515', 'cui_str': 'corn starch'}]","[{'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0005775', 'cui_str': 'Circulation, Blood'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0007818', 'cui_str': 'Circulation, Cerebrovascular'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0522534', 'cui_str': 'Saturated'}, {'cui': 'C1862322', 'cui_str': 'Southeast Asian ovalocytosis'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0232555', 'cui_str': 'Peak gastric acid output'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C0030604', 'cui_str': 'Partial pressure'}, {'cui': 'C0007276', 'cui_str': 'Internal carotid artery structure'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0042559', 'cui_str': 'Structure of vertebral artery'}, {'cui': 'C0162481', 'cui_str': 'Doppler ultrasound'}, {'cui': 'C0429622', 'cui_str': 'Oxygen delivery'}]",9.0,0.0504265,"IHX reduced SaO 2 and PaO 2 , but placebo did not affect ICABF, VABF, tCBF, or CDO 2 responses.","[{'ForeName': 'Marcos P', 'Initials': 'MP', 'LastName': 'Rocha', 'Affiliation': 'Laboratory of Exercise Sciences, Department of Physiology and Pharmacology, Fluminense Federal University, RJ, Brazil.'}, {'ForeName': 'Monique O', 'Initials': 'MO', 'LastName': 'Campos', 'Affiliation': 'Laboratory of Exercise Sciences, Department of Physiology and Pharmacology, Fluminense Federal University, RJ, Brazil.'}, {'ForeName': 'João D', 'Initials': 'JD', 'LastName': 'Mattos', 'Affiliation': 'Laboratory of Exercise Sciences, Department of Physiology and Pharmacology, Fluminense Federal University, RJ, Brazil.'}, {'ForeName': 'Daniel E', 'Initials': 'DE', 'LastName': 'Mansur', 'Affiliation': 'Laboratory of Exercise Sciences, Department of Physiology and Pharmacology, Fluminense Federal University, RJ, Brazil.'}, {'ForeName': 'Helena N M', 'Initials': 'HNM', 'LastName': 'Rocha', 'Affiliation': 'Laboratory of Exercise Sciences, Department of Physiology and Pharmacology, Fluminense Federal University, RJ, Brazil.'}, {'ForeName': 'Niels H', 'Initials': 'NH', 'LastName': 'Secher', 'Affiliation': 'Department of Anaesthesia, The Copenhagen Muscle Research Centre, Rigshospitalet, University of Copenhagen, Denmark.'}, {'ForeName': 'Antonio C L', 'Initials': 'ACL', 'LastName': 'Nóbrega', 'Affiliation': 'Laboratory of Exercise Sciences, Department of Physiology and Pharmacology, Fluminense Federal University, RJ, Brazil.'}, {'ForeName': 'Igor A', 'Initials': 'IA', 'LastName': 'Fernandes', 'Affiliation': 'NeuroV̇ASQ̇-Integrative Physiology Laboratory, Faculty of Physical Education, University of Brasília, Brazil.'}]",The Journal of physiology,['10.1113/JP279751'] 1977,31028057,Indinavir Increases Midazolam N -Glucuronidation in Humans: Identification of an Alternate CYP3A Inhibitor Using an In Vitro to In Vivo Approach.,"Midazolam is a widely used index substrate for assessing effects of xenobiotics on CYP3A activity. A previous study involving human hepatocytes showed the primary route of midazolam metabolism, 1'-hydroxylation, shifted to N -glucuronidation in the presence of the CYP3A inhibitor ketoconazole, which may lead to an overprediction of the magnitude of a xenobiotic-midazolam interaction. Because ketoconazole is no longer recommended as a clinical CYP3A inhibitor, indinavir was selected as an alternate CYP3A inhibitor to evaluate the contribution of the N -glucuronidation pathway to midazolam metabolism. The effects of indinavir on midazolam 1'-hydroxylation and N -glucuronidation were first characterized in human-derived in vitro systems. Compared with vehicle, indinavir (10 μ M) inhibited midazolam 1'-hydroxylation by recombinant CYP3A4, human liver microsomes, and high-CYP3A activity cryopreserved human hepatocytes by ≥70%; the IC 50 obtained with hepatocytes (2.7 μ M) was within reported human unbound indinavir C max (≤5 μ M). Midazolam N -glucuronidation in hepatocytes increased in the presence of indinavir in both a concentration-dependent (1-33 μ M) and time-dependent (0-4 hours) manner (by up to 2.5-fold), prompting assessment in human volunteers ( n = 8). As predicted by these in vitro data, indinavir was a strong inhibitor of the 1'-hydroxylation pathway, decreasing the 1'-hydroxymidazolam/midazolam area under the plasma concentration versus time curve (AUC) 0-12h ratio by 80%. Although not statistically significant, the midazolam N -glucuronide/midazolam AUC 0-12h ratio increased by 40%, suggesting a shift to the N -glucuronidation pathway. The amount of midazolam N -glucuronide recovered in urine increased 4-fold but remained <10% of the oral midazolam dose (2.5 mg). A powered clinical study would clarify whether N -glucuronidation should be considered when assessing the magnitude of a xenobiotic-midazolam interaction.",2019,"Compared with vehicle, indinavir (10 μ M) inhibited midazolam 1'-hydroxylation by recombinant CYP3A4, human liver microsomes, and high-CYP3A activity cryopreserved human hepatocytes by ≥70%; the IC 50 obtained with hepatocytes (2.7 μ M) was within reported human unbound indinavir C max (≤5 μ M).",['N -Glucuronidation in Humans'],"['Midazolam', 'ketoconazole', 'oral midazolam', 'vehicle, indinavir', 'Indinavir', 'indinavir']","['amount of midazolam N -glucuronide recovered in urine', 'midazolam N -glucuronide/midazolam AUC 0-12h ratio']","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}]","[{'cui': 'C0026056', 'cui_str': 'Midazolam'}, {'cui': 'C0022625', 'cui_str': 'Ketoconazole'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0042444', 'cui_str': 'Drug vehicle'}, {'cui': 'C0376637', 'cui_str': 'Indinavir'}]","[{'cui': 'C0026056', 'cui_str': 'Midazolam'}, {'cui': 'C0752086', 'cui_str': 'Glucuronides'}, {'cui': 'C0521108', 'cui_str': 'Recovering from'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0456695', 'cui_str': '/12h'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",,0.0362997,"Compared with vehicle, indinavir (10 μ M) inhibited midazolam 1'-hydroxylation by recombinant CYP3A4, human liver microsomes, and high-CYP3A activity cryopreserved human hepatocytes by ≥70%; the IC 50 obtained with hepatocytes (2.7 μ M) was within reported human unbound indinavir C max (≤5 μ M).","[{'ForeName': 'Dan-Dan', 'Initials': 'DD', 'LastName': 'Tian', 'Affiliation': 'Department of Pharmaceutical Sciences, Washington State University, Spokane, Washington (D.-D.T., E.J.C., V.G.-P., M.F.P.); Division of Gastroenterology and Hepatology, School of Medicine (Y.V.S.) and Division of Pharmacotherapy and Experimental Therapeutics, Eshelman School of Pharmacy (C.L.), University of North Carolina at Chapel Hill, Chapel Hill, North Carolina; and Boehringer-Ingelheim Pharmaceuticals, Ridgefield, Connecticut (K.S.F., M.B.F.).'}, {'ForeName': 'Cathrine', 'Initials': 'C', 'LastName': 'Leonowens', 'Affiliation': 'Department of Pharmaceutical Sciences, Washington State University, Spokane, Washington (D.-D.T., E.J.C., V.G.-P., M.F.P.); Division of Gastroenterology and Hepatology, School of Medicine (Y.V.S.) and Division of Pharmacotherapy and Experimental Therapeutics, Eshelman School of Pharmacy (C.L.), University of North Carolina at Chapel Hill, Chapel Hill, North Carolina; and Boehringer-Ingelheim Pharmaceuticals, Ridgefield, Connecticut (K.S.F., M.B.F.).'}, {'ForeName': 'Emily J', 'Initials': 'EJ', 'LastName': 'Cox', 'Affiliation': 'Department of Pharmaceutical Sciences, Washington State University, Spokane, Washington (D.-D.T., E.J.C., V.G.-P., M.F.P.); Division of Gastroenterology and Hepatology, School of Medicine (Y.V.S.) and Division of Pharmacotherapy and Experimental Therapeutics, Eshelman School of Pharmacy (C.L.), University of North Carolina at Chapel Hill, Chapel Hill, North Carolina; and Boehringer-Ingelheim Pharmaceuticals, Ridgefield, Connecticut (K.S.F., M.B.F.).'}, {'ForeName': 'Vanessa', 'Initials': 'V', 'LastName': 'González-Pérez', 'Affiliation': 'Department of Pharmaceutical Sciences, Washington State University, Spokane, Washington (D.-D.T., E.J.C., V.G.-P., M.F.P.); Division of Gastroenterology and Hepatology, School of Medicine (Y.V.S.) and Division of Pharmacotherapy and Experimental Therapeutics, Eshelman School of Pharmacy (C.L.), University of North Carolina at Chapel Hill, Chapel Hill, North Carolina; and Boehringer-Ingelheim Pharmaceuticals, Ridgefield, Connecticut (K.S.F., M.B.F.).'}, {'ForeName': 'Kosea S', 'Initials': 'KS', 'LastName': 'Frederick', 'Affiliation': 'Department of Pharmaceutical Sciences, Washington State University, Spokane, Washington (D.-D.T., E.J.C., V.G.-P., M.F.P.); Division of Gastroenterology and Hepatology, School of Medicine (Y.V.S.) and Division of Pharmacotherapy and Experimental Therapeutics, Eshelman School of Pharmacy (C.L.), University of North Carolina at Chapel Hill, Chapel Hill, North Carolina; and Boehringer-Ingelheim Pharmaceuticals, Ridgefield, Connecticut (K.S.F., M.B.F.).'}, {'ForeName': 'Yolanda V', 'Initials': 'YV', 'LastName': 'Scarlett', 'Affiliation': 'Department of Pharmaceutical Sciences, Washington State University, Spokane, Washington (D.-D.T., E.J.C., V.G.-P., M.F.P.); Division of Gastroenterology and Hepatology, School of Medicine (Y.V.S.) and Division of Pharmacotherapy and Experimental Therapeutics, Eshelman School of Pharmacy (C.L.), University of North Carolina at Chapel Hill, Chapel Hill, North Carolina; and Boehringer-Ingelheim Pharmaceuticals, Ridgefield, Connecticut (K.S.F., M.B.F.).'}, {'ForeName': 'Michael B', 'Initials': 'MB', 'LastName': 'Fisher', 'Affiliation': 'Department of Pharmaceutical Sciences, Washington State University, Spokane, Washington (D.-D.T., E.J.C., V.G.-P., M.F.P.); Division of Gastroenterology and Hepatology, School of Medicine (Y.V.S.) and Division of Pharmacotherapy and Experimental Therapeutics, Eshelman School of Pharmacy (C.L.), University of North Carolina at Chapel Hill, Chapel Hill, North Carolina; and Boehringer-Ingelheim Pharmaceuticals, Ridgefield, Connecticut (K.S.F., M.B.F.).'}, {'ForeName': 'Mary F', 'Initials': 'MF', 'LastName': 'Paine', 'Affiliation': 'Department of Pharmaceutical Sciences, Washington State University, Spokane, Washington (D.-D.T., E.J.C., V.G.-P., M.F.P.); Division of Gastroenterology and Hepatology, School of Medicine (Y.V.S.) and Division of Pharmacotherapy and Experimental Therapeutics, Eshelman School of Pharmacy (C.L.), University of North Carolina at Chapel Hill, Chapel Hill, North Carolina; and Boehringer-Ingelheim Pharmaceuticals, Ridgefield, Connecticut (K.S.F., M.B.F.) mary.paine@wsu.edu.'}]",Drug metabolism and disposition: the biological fate of chemicals,['10.1124/dmd.119.087007'] 1978,31806881,"OPRM1, OPRK1, and COMT genetic polymorphisms associated with opioid effects on experimental pain: a randomized, double-blind, placebo-controlled study.","Genetic polymorphisms have been shown to affect opioid requirement for pain relief. However, true genetic effect is often difficult to assess due to underlying pain conditions and placebo effects. The goal of this study was to understand how common polymorphisms affect opioid effects while controlling for these factors. A randomized, double-blind, placebo-controlled study was implemented to assess how opioid effects are modulated by COMT (rs6269, rs4633, rs4848, rs4680), OPRM1 (A118G), and OPRK1 (rs1051660, rs702764, rs16918875). One hundred and eight healthy subjects underwent experimental pain testing before and after morphine, butorphanol, and placebo (saline). Association analysis was performed between polymorphisms/haplotypes and opioid response, while correcting for race, gender, placebo effects, and multiple comparisons. Pressure pain was significantly associated with rs6269 and rs4633 following butorphanol. The AA genotype of rs4680 or A_T_C_A/ A_T_C_A (rs6269_rs4633_ rs4818_rs4680) diplotype of COMT, combined with the AG genotype of OPRM1 A118G, showed significantly increased pressure pain threshold from butorphanol. Opioid effects on pressure, ischemic, heat pain, and side effects were nominally associated with several SNPs and haplotypes. Effects were often present in one opioid but not the other. This indicates that these polymorphisms affect pain relief from opioids, and that their effects are opioid and pain modality specific.",2020,Pressure pain was significantly associated with rs6269 and rs4633 following butorphanol.,['One hundred and eight healthy subjects'],"['butorphanol', 'morphine, butorphanol, and placebo (saline', 'placebo']","['Pressure pain', 'pressure, ischemic, heat pain, and side effects', 'pressure pain', 'experimental pain']","[{'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0006491', 'cui_str': 'Butorphanol'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}]","[{'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",108.0,0.58088,Pressure pain was significantly associated with rs6269 and rs4633 following butorphanol.,"[{'ForeName': 'Kwo Wei David', 'Initials': 'KWD', 'LastName': 'Ho', 'Affiliation': 'Department of Anesthesiology, Perioperative and Pain Medicine, Division of Pain Medicine, Stanford University, Redwood City, CA, USA. kwoweiho@stanford.edu.'}, {'ForeName': 'Margaret R', 'Initials': 'MR', 'LastName': 'Wallace', 'Affiliation': 'Department of Molecular Genetics & Microbiology, and UF Genetics Institute, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Staud', 'Affiliation': 'Department of Medicine, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Roger B', 'Initials': 'RB', 'LastName': 'Fillingim', 'Affiliation': 'Department of Community Dentistry and Behavioral Science, University of Florida, Gainesville, FL, USA.'}]",The pharmacogenomics journal,['10.1038/s41397-019-0131-z'] 1979,32466729,"Computable Phenotype Implementation for a National, Multicenter Pragmatic Clinical Trial: Lessons Learned From ADAPTABLE.","BACKGROUND Many large-scale cardiovascular clinical trials are plagued with escalating costs and low enrollment. Implementing a computable phenotype, which is a set of executable algorithms, to identify a group of clinical characteristics derivable from electronic health records or administrative claims records, is essential to successful recruitment in large-scale pragmatic clinical trials. This methods paper provides an overview of the development and implementation of a computable phenotype in ADAPTABLE (Aspirin Dosing: a Patient-Centric Trial Assessing Benefits and Long-Term Effectiveness)-a pragmatic, randomized, open-label clinical trial testing the optimal dose of aspirin for secondary prevention of atherosclerotic cardiovascular disease events. METHODS AND RESULTS A multidisciplinary team developed and tested the computable phenotype to identify adults ≥18 years of age with a history of atherosclerotic cardiovascular disease without safety concerns around using aspirin and meeting trial eligibility criteria. Using the computable phenotype, investigators identified over 650 000 potentially eligible patients from the 40 participating sites from Patient-Centered Outcomes Research Network-a network of Clinical Data Research Networks, Patient-Powered Research Networks, and Health Plan Research Networks. Leveraging diverse recruitment methods, sites enrolled 15 076 participants from April 2016 to June 2019. During the process of developing and implementing the ADAPTABLE computable phenotype, several key lessons were learned. The accuracy and utility of a computable phenotype are dependent on the quality of the source data, which can be variable even with a common data model. Local validation and modification were required based on site factors, such as recruitment strategies, data quality, and local coding patterns. Sustained collaboration among a diverse team of researchers is needed during computable phenotype development and implementation. CONCLUSIONS The ADAPTABLE computable phenotype served as an efficient method to recruit patients in a multisite pragmatic clinical trial. This process of development and implementation will be informative for future large-scale, pragmatic clinical trials. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02697916.",2020,"Local validation and modification were required based on site factors, such as recruitment strategies, data quality, and local coding patterns.","['Leveraging diverse recruitment methods, sites enrolled 15 076 participants from April 2016 to June 2019', '650 000 potentially eligible patients from the 40 participating sites from Patient-Centered Outcomes Research Network-a network of Clinical Data Research Networks, Patient-Powered Research Networks, and Health Plan Research Networks', 'adults ≥18 years of age with a history of atherosclerotic cardiovascular disease without safety concerns around using aspirin and meeting trial eligibility criteria']","['Aspirin', 'aspirin']",[],"[{'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C3844101', 'cui_str': '650'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0032863', 'cui_str': 'Power (Psychology)'}, {'cui': 'C0018727', 'cui_str': 'Health Planning'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0004153', 'cui_str': 'Atherosclerosis'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0004057', 'cui_str': 'Aspirin'}]",[],15076.0,0.152651,"Local validation and modification were required based on site factors, such as recruitment strategies, data quality, and local coding patterns.","[{'ForeName': 'Faraz S', 'Initials': 'FS', 'LastName': 'Ahmad', 'Affiliation': 'Department of Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL (F.S.A.).'}, {'ForeName': 'Iben M', 'Initials': 'IM', 'LastName': 'Ricket', 'Affiliation': 'Louisiana Public Health Institute, New Orleans (I.M.R.).'}, {'ForeName': 'Bradley G', 'Initials': 'BG', 'LastName': 'Hammill', 'Affiliation': 'Duke University School of Medicine, Durham, NC (B.G.H., M.T.R., W.S.J.).'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Eskenazi', 'Affiliation': 'Duke Clinical Research Institute, Durham, NC (B.G.H., L.E., H.R., L.H.C., M.T.R., W.S.J.).'}, {'ForeName': 'Holly R', 'Initials': 'HR', 'LastName': 'Robertson', 'Affiliation': 'Duke Clinical Research Institute, Durham, NC (B.G.H., L.E., H.R., L.H.C., M.T.R., W.S.J.).'}, {'ForeName': 'Lesley H', 'Initials': 'LH', 'LastName': 'Curtis', 'Affiliation': 'Duke Clinical Research Institute, Durham, NC (B.G.H., L.E., H.R., L.H.C., M.T.R., W.S.J.).'}, {'ForeName': 'Cecilia D', 'Initials': 'CD', 'LastName': 'Dobi', 'Affiliation': 'Department of Clinical Sciences, Lewis Katz School of Medicine at Temple University, Philadelphia, PA (C.D.D.).'}, {'ForeName': 'Saket', 'Initials': 'S', 'LastName': 'Girotra', 'Affiliation': 'University of Iowa Carver College of Medicine, Iowa City (S.G.).'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Haynes', 'Affiliation': 'Scientific Affairs, HealthCore, Inc., Wilmington, DE (K.H.).'}, {'ForeName': 'Jorge R', 'Initials': 'JR', 'LastName': 'Kizer', 'Affiliation': 'Cardiology Section, San Francisco Veterans Affairs Health Care System, CA (J.R.K.).'}, {'ForeName': 'Sunil', 'Initials': 'S', 'LastName': 'Kripalani', 'Affiliation': 'Department of Medicine, Vanderbilt University Medical Center, Veterans Health Administration-Tennessee Valley Healthcare System Geriatric Research Education Clinical Center, Health Services Research and Development Center, Nashville, TN (S.K., C.L.R.).'}, {'ForeName': 'Mathew T', 'Initials': 'MT', 'LastName': 'Roe', 'Affiliation': 'Duke University School of Medicine, Durham, NC (B.G.H., M.T.R., W.S.J.).'}, {'ForeName': 'Christianne L', 'Initials': 'CL', 'LastName': 'Roumie', 'Affiliation': 'Department of Medicine, Vanderbilt University Medical Center, Veterans Health Administration-Tennessee Valley Healthcare System Geriatric Research Education Clinical Center, Health Services Research and Development Center, Nashville, TN (S.K., C.L.R.).'}, {'ForeName': 'Russ', 'Initials': 'R', 'LastName': 'Waitman', 'Affiliation': 'Department of Internal Medicine, University of Kansas Medical Center, Kansas City, KS (R.W.).'}, {'ForeName': 'W Schuyler', 'Initials': 'WS', 'LastName': 'Jones', 'Affiliation': 'Duke University School of Medicine, Durham, NC (B.G.H., M.T.R., W.S.J.).'}, {'ForeName': 'Mark G', 'Initials': 'MG', 'LastName': 'Weiner', 'Affiliation': 'Department of Population Health Sciences, Weill Cornell Medicine, New York Presbyterian-Weill Cornell Campus, New York (M.G.W.).'}]",Circulation. Cardiovascular quality and outcomes,['10.1161/CIRCOUTCOMES.119.006292'] 1980,32464527,Community-level interventions for pre-eclampsia (CLIP) in Mozambique: A cluster randomised controlled trial.,"OBJECTIVES Pregnancy hypertension is the third leading cause of maternal mortality in Mozambique and contributes significantly to fetal and neonatal mortality. The objective of this trial was to assess whether task-sharing care might reduce adverse pregnancy outcomes related to delays in triage, transport, and treatment. STUDY DESIGN The Mozambique Community-Level Interventions for Pre-eclampsia (CLIP) cluster randomised controlled trial (NCT01911494) recruited pregnant women in 12 administrative posts (clusters) in Maputo and Gaza Provinces. The CLIP intervention (6 clusters) consisted of community engagement, community health worker-provided mobile health-guided clinical assessment, initial treatment, and referral to facility either urgently (<4hrs) or non-urgently (<24hrs), dependent on algorithm-defined risk. Treatment effect was estimated by multi-level logistic regression modelling, adjusted for prognostically-significant baseline variables. Predefined secondary analyses included safety and evaluation of the intensity of CLIP contacts. MAIN OUTCOME MEASURES 20% reduction in composite of maternal, fetal, and newborn mortality and major morbidity. RESULTS 15,013 women (15,123 pregnancies) were recruited in intervention (N = 7930; 2·0% loss to follow-up (LTFU)) and control (N = 7190; 2·8% LTFU) clusters. The primary outcome did not differ between intervention and control clusters (adjusted odds ratio (aOR) 1·31, 95% confidence interval (CI) [0·70, 2·48]; p = 0·40). Compared with intervention arm women without CLIP contacts, those with ≥8 contacts experienced fewer primary outcomes (aOR 0·79 (95% CI 0·63, 0·99); p = 0·041), primarily due to improved maternal outcomes (aOR 0·72 (95% CI 0·53, 0·97); p = 0·033). INTERPRETATION As generally implemented, the CLIP intervention did not improve pregnancy outcomes; community implementation of the WHO eight contact model may be beneficial. FUNDING The University of British Columbia (PRE-EMPT), a grantee of the Bill & Melinda Gates Foundation (OPP1017337).",2020,"The primary outcome did not differ between intervention and control clusters (adjusted odds ratio (aOR) 1·31, 95% confidence interval (CI) [0·70, 2·48]; p = 0·40).","['pre-eclampsia (CLIP) in Mozambique', 'pregnant women in 12 administrative posts (clusters) in Maputo and Gaza Provinces', '15,013 women (15,123 pregnancies']","['CLIP intervention', 'task-sharing care', 'CLIP intervention (6 clusters) consisted of community engagement, community health worker-provided mobile health-guided clinical assessment, initial treatment, and referral to facility either urgently (<4hrs) or non-urgently', 'Community-level interventions', 'Mozambique Community-Level Interventions']","['maternal outcomes', 'composite of maternal, fetal, and newborn mortality and major morbidity', 'safety and evaluation of the intensity of CLIP contacts']","[{'cui': 'C0032914', 'cui_str': 'Pre-eclampsia'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0026655', 'cui_str': 'Mozambique'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C1292785', 'cui_str': 'Administrative action'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0032914', 'cui_str': 'Pre-eclampsia'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0009467', 'cui_str': 'Community Health Aides'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C2585021', 'cui_str': 'Referral to'}, {'cui': 'C0026655', 'cui_str': 'Mozambique'}]","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0015965', 'cui_str': 'Fetuses'}, {'cui': 'C0027616', 'cui_str': 'Neonatal Mortality'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0032914', 'cui_str': 'Pre-eclampsia'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}]",15013.0,0.295538,"The primary outcome did not differ between intervention and control clusters (adjusted odds ratio (aOR) 1·31, 95% confidence interval (CI) [0·70, 2·48]; p = 0·40).","[{'ForeName': 'Esperança', 'Initials': 'E', 'LastName': 'Sevene', 'Affiliation': 'Centro de Investigação em Saúde da Manhiça (CISM), Rua 12, Cambeve, Manhiça, CP 1929 Maputo, Mozambique; Faculdade de Medicina, Universidade Eduardo Mondlane, Av. Salvador Allende nr. 702, Maputo, Mozambique. Electronic address: esperanca.sevene@manhica.net.'}, {'ForeName': 'Sumedha', 'Initials': 'S', 'LastName': 'Sharma', 'Affiliation': 'Department of Obstetrics and Gynaecology, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver V6Z 2K8, Canada.'}, {'ForeName': 'Khátia', 'Initials': 'K', 'LastName': 'Munguambe', 'Affiliation': 'Centro de Investigação em Saúde da Manhiça (CISM), Rua 12, Cambeve, Manhiça, CP 1929 Maputo, Mozambique; Faculdade de Medicina, Universidade Eduardo Mondlane, Av. Salvador Allende nr. 702, Maputo, Mozambique.'}, {'ForeName': 'Charfudin', 'Initials': 'C', 'LastName': 'Sacoor', 'Affiliation': 'Centro de Investigação em Saúde da Manhiça (CISM), Rua 12, Cambeve, Manhiça, CP 1929 Maputo, Mozambique.'}, {'ForeName': 'Anifa', 'Initials': 'A', 'LastName': 'Vala', 'Affiliation': 'Centro de Investigação em Saúde da Manhiça (CISM), Rua 12, Cambeve, Manhiça, CP 1929 Maputo, Mozambique.'}, {'ForeName': 'Salésio', 'Initials': 'S', 'LastName': 'Macuacua', 'Affiliation': 'Centro de Investigação em Saúde da Manhiça (CISM), Rua 12, Cambeve, Manhiça, CP 1929 Maputo, Mozambique; Direcção Provincial de Saúde, Ministério da Saúde, Av. Eduardo Mondlane n(o) 1008, CP 264 Maputo, Mozambique.'}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Boene', 'Affiliation': 'Centro de Investigação em Saúde da Manhiça (CISM), Rua 12, Cambeve, Manhiça, CP 1929 Maputo, Mozambique.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Mark Ansermino', 'Affiliation': 'Centre for International Child Health, University of British Columbia, 305 - 4088 Cambie Street, Vancouver V5Z 2X8, Canada.'}, {'ForeName': 'Orvalho', 'Initials': 'O', 'LastName': 'Augusto', 'Affiliation': 'Centro de Investigação em Saúde da Manhiça (CISM), Rua 12, Cambeve, Manhiça, CP 1929 Maputo, Mozambique; Faculdade de Medicina, Universidade Eduardo Mondlane, Av. Salvador Allende nr. 702, Maputo, Mozambique.'}, {'ForeName': 'Cassimo', 'Initials': 'C', 'LastName': 'Bique', 'Affiliation': 'Departamento de Ginecologia e Obstetrícia, Hospital Central de Maputo, Av. Agostinho Neto n(o) 167, CP 1164 Maputo, Mozambique.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Bone', 'Affiliation': 'Department of Obstetrics and Gynaecology, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver V6Z 2K8, Canada.'}, {'ForeName': 'Dustin T', 'Initials': 'DT', 'LastName': 'Dunsmuir', 'Affiliation': 'Centre for International Child Health, University of British Columbia, 305 - 4088 Cambie Street, Vancouver V5Z 2X8, Canada.'}, {'ForeName': 'Tang', 'Initials': 'T', 'LastName': 'Lee', 'Affiliation': 'Department of Obstetrics and Gynaecology, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver V6Z 2K8, Canada.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Obstetrics and Gynaecology, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver V6Z 2K8, Canada.'}, {'ForeName': 'Eusébio', 'Initials': 'E', 'LastName': 'Macete', 'Affiliation': 'Centro de Investigação em Saúde da Manhiça (CISM), Rua 12, Cambeve, Manhiça, CP 1929 Maputo, Mozambique; Instituto Nacional de Saúde, Ministério da Saúde, Distrito de Marracuene, Estrada Nacional N(o) 1, Maputo, Mozambique.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Singer', 'Affiliation': ""Centre for Health Evaluation and Outcome Sciences, Providence Health Care Research Institute, University of British Columbia, 588 - 1081 Burrard Street, St. Paul's Hospital, Vancouver V6Z 1Y6, Canada.""}, {'ForeName': 'Hubert', 'Initials': 'H', 'LastName': 'Wong', 'Affiliation': ""Centre for Health Evaluation and Outcome Sciences, Providence Health Care Research Institute, University of British Columbia, 588 - 1081 Burrard Street, St. Paul's Hospital, Vancouver V6Z 1Y6, Canada.""}, {'ForeName': 'Hannah L', 'Initials': 'HL', 'LastName': 'Nathan', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, Faculty of Medicine and Life Sciences, King's College London, 1 Lambeth Place Road, London SE1 7EH, UK.""}, {'ForeName': 'Beth A', 'Initials': 'BA', 'LastName': 'Payne', 'Affiliation': 'Centre for International Child Health, University of British Columbia, 305 - 4088 Cambie Street, Vancouver V5Z 2X8, Canada.'}, {'ForeName': 'Mohsin', 'Initials': 'M', 'LastName': 'Sidat', 'Affiliation': 'Faculdade de Medicina, Universidade Eduardo Mondlane, Av. Salvador Allende nr. 702, Maputo, Mozambique.'}, {'ForeName': 'Andrew H', 'Initials': 'AH', 'LastName': 'Shennan', 'Affiliation': ""Department of Women and Children's Health, School of Life Course Sciences, Faculty of Medicine and Life Sciences, King's College London, 1 Lambeth Place Road, London SE1 7EH, UK.""}, {'ForeName': 'Corssino', 'Initials': 'C', 'LastName': 'Tchavana', 'Affiliation': 'Centro de Investigação em Saúde da Manhiça (CISM), Rua 12, Cambeve, Manhiça, CP 1929 Maputo, Mozambique.'}, {'ForeName': 'Domena K', 'Initials': 'DK', 'LastName': 'Tu', 'Affiliation': 'Department of Obstetrics and Gynaecology, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver V6Z 2K8, Canada.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Vidler', 'Affiliation': 'Department of Obstetrics and Gynaecology, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver V6Z 2K8, Canada.'}, {'ForeName': 'Zulfiqar A', 'Initials': 'ZA', 'LastName': 'Bhutta', 'Affiliation': 'Centre for Global Child Health, Hospital for Sick Children, 525 University Avenue, Suite 702, Toronto M5G 2L3, Canada.'}, {'ForeName': 'Laura A', 'Initials': 'LA', 'LastName': 'Magee', 'Affiliation': ""Department of Obstetrics and Gynaecology, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver V6Z 2K8, Canada; Department of Women and Children's Health, School of Life Course Sciences, Faculty of Medicine and Life Sciences, King's College London, 1 Lambeth Place Road, London SE1 7EH, UK.""}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'von Dadelszen', 'Affiliation': ""Department of Obstetrics and Gynaecology, University of British Columbia, Suite 930, 1125 Howe Street, Vancouver V6Z 2K8, Canada; Department of Women and Children's Health, School of Life Course Sciences, Faculty of Medicine and Life Sciences, King's College London, 1 Lambeth Place Road, London SE1 7EH, UK.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Pregnancy hypertension,['10.1016/j.preghy.2020.05.006'] 1981,32472792,Clinical Efficacy of Immediate Manual Meibomian Gland Expression After Thermal Pulsation (LipiFlow) for Obstructive Meibomian Gland Dysfunction: Comparison With Thermal Pulsation.,"PURPOSE To evaluate the clinical efficacy and safety of immediate manual meibomian gland expression (MGX) after LipiFlow thermal pulsation (TearScience Inc, Morrisville, NC) for obstructive meibomian gland dysfunction and to compare the LipiFlow only and MGX after LipiFlow. METHODS Patients who underwent immediate manual MGX after LipiFlow or who received only LipiFlow treatment were included. Thirty eyes from 15 patients were enrolled in each group. All patients underwent 3 treatments at monthly intervals. All patients were followed up for 6 months after treatment. All patients were examined before and at 3 and 6 months after treatment. Examinations included the Ocular Surface Disease Index score, noninvasive tear film breakup time (NIBUT), lipid layer thickness (LLT), corneal and conjunctival staining, and tear meniscus height. RESULTS The Ocular Surface Disease Index scores improved in both groups during the follow-up periods (P = 0.001 and P = 0.001). In the LipiFlow-only group, the NIBUT and LLT significantly improved at 3 months (P < 0.001 and P = 0.006) but deteriorated at 6 months. In the MGX after LipiFlow group, the NIBUT and LLT improved at 3 months (P < 0.001 and P < 0.001), and this improvement was maintained at 6 months. The improvement of NIBUT at 3 months was greater in the MGX after LipiFlow group (3.24 ± 1.16 to 9.25 ± 1.36 s) than in the LipiFlow-only group (3.78 ± 1.75 to 7.18 ± 2.70 s), and the improvements of the LLT at 6 months were greater in the MGX after LipiFlow group (30.27 ± 10.74 to 46.93 ± 20.81 μm) than in the LipiFlow-only group (34.70 ± 10.79 to 38.73 ± 14.70 μm). CONCLUSIONS Both LipiFlow only and MGX after LipiFlow were clinically effective for obstructive meibomian gland dysfunction. However, the efficacy and persistence of treatment were greater in patients who received MGX after LipiFlow.",2020,The Ocular Surface Disease Index scores improved in both groups during the follow-up periods (P = 0.001 and P = 0.001).,"['Patients who underwent immediate manual MGX after LipiFlow or who received only LipiFlow treatment were included', 'Thirty eyes from 15 patients were enrolled in each group', 'Obstructive Meibomian Gland Dysfunction']","['Immediate Manual Meibomian Gland Expression', 'Thermal Pulsation (LipiFlow', 'immediate manual meibomian gland expression (MGX) after LipiFlow thermal pulsation (TearScience Inc, Morrisville, NC']","['Ocular Surface Disease Index score, noninvasive tear film breakup time (NIBUT), lipid layer thickness (LLT), corneal and conjunctival staining, and tear meniscus height', 'Ocular Surface Disease Index scores', 'NIBUT and LLT', 'improvement of NIBUT']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0025181', 'cui_str': 'Structure of meibomian gland'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1275684', 'cui_str': 'Meibomian gland dysfunction'}]","[{'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0025181', 'cui_str': 'Structure of meibomian gland'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}]","[{'cui': 'C1557335', 'cui_str': 'Ocular surface disease'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C1704608', 'cui_str': 'Film'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C3203718', 'cui_str': 'Conjunctival staining'}, {'cui': 'C1827565', 'cui_str': 'Tear meniscus height'}]",30.0,0.0233914,The Ocular Surface Disease Index scores improved in both groups during the follow-up periods (P = 0.001 and P = 0.001).,"[{'ForeName': 'Hye Jee', 'Initials': 'HJ', 'LastName': 'Kim', 'Affiliation': 'Department of Medicine, Graduate School, Kyung Hee University, Seoul, Republic of Korea.'}, {'ForeName': 'Jin Hyoung', 'Initials': 'JH', 'LastName': 'Park', 'Affiliation': 'Miso Eye Clinic, Gyeonggi-do, Republic of Korea.'}]",Cornea,['10.1097/ICO.0000000000002328'] 1982,32470863,The effect of Korean Red Ginseng on sarcopenia biomarkers in type 2 diabetes patients.,"BACKGROUND The elderly population is growing rapidly worldwide and sarcopenia, which is considered as a new geriatric syndrome has become an important issue. In particular, diabetes is known to be an important risk factor for sarcopenia. In this study, we investigated the effects of Korean Red Ginseng (KRG) on biomarkers of sarcopenia in middle and old age diabetes patients. PATIENTS AND METHODS This study was a randomized, double-blind, placebo-controlled trial. Participants were randomly allocated to either the placebo or KRG group and took corresponding tablets for 24 weeks. The primary outcomes were changes in sarcopenia biomarkers at week 24. Secondary outcomes were changes in inflammatory and antioxidant markers and lean body mass at week 24. RESULTS Fifty-nine patients completed the study. Follistatin and sex hormone binding globulin (SHBG) were significantly improved in KRG group. In the subgroup analysis, female postmenopausal patients over the age of 55 showed a significant improvement in serum SHBG, follistatin, and growth differentiation factor 15 (GDF-15) and an attenuated reduction in Troponin T (TNT) after the administration of KRG. CONCLUSION Twenty-four week administration of KRG in diabetes patients resulted in a significant improvement in follistatin and SHBG levels, especially in old postmenopausal women. A further, larger population study with a longer follow-up period is warranted to verify and understand the effects of KRG on sarcopenia.",2020,"Twenty-four week administration of KRG in diabetes patients resulted in a significant improvement in follistatin and SHBG levels, especially in old postmenopausal women.","['type 2 diabetes patients', 'Fifty-nine patients completed the study', 'middle and old age diabetes patients', 'old postmenopausal women']","['placebo or KRG', 'Korean Red Ginseng (KRG', 'KRG', 'Korean Red Ginseng', 'placebo']","['serum SHBG, follistatin, and growth differentiation factor 15 (GDF-15) and an attenuated reduction in Troponin T (TNT', 'sarcopenia biomarkers', 'changes in inflammatory and antioxidant markers and lean body mass', 'changes in sarcopenia biomarkers', 'follistatin and SHBG levels', 'Follistatin and sex hormone binding globulin (SHBG']","[{'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3830128', 'cui_str': '59'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0231337', 'cui_str': 'Senility'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C0873137', 'cui_str': 'Korean ginseng preparation'}]","[{'cui': 'C0455307', 'cui_str': 'Serum sex hormone binding globulin measurement'}, {'cui': 'C0060623', 'cui_str': 'Activin-Binding Protein'}, {'cui': 'C0668195', 'cui_str': 'Macrophage Inhibitory Cytokine 1'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0077404', 'cui_str': 'Troponin T'}, {'cui': 'C0872084', 'cui_str': 'Sarcopenia'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0424678', 'cui_str': 'Lean body mass'}, {'cui': 'C0202218', 'cui_str': 'Sex hormone binding globulin measurement'}, {'cui': 'C0036883', 'cui_str': 'Sex steroid binding globulin'}]",59.0,0.135337,"Twenty-four week administration of KRG in diabetes patients resulted in a significant improvement in follistatin and SHBG levels, especially in old postmenopausal women.","[{'ForeName': 'Kahui', 'Initials': 'K', 'LastName': 'Park', 'Affiliation': 'Department of Internal Medicine, Yonsei University College of Medicine, 63 gil 20, Eonguro, Gangnam-gu, Seoul, 06229, Republic of Korea.'}, {'ForeName': 'Chul Woo', 'Initials': 'CW', 'LastName': 'Ahn', 'Affiliation': 'Department of Internal Medicine, Yonsei University College of Medicine, 63 gil 20, Eonguro, Gangnam-gu, Seoul, 06229, Republic of Korea; Severance Institute for Vascular and Metabolic Research, College of Medicine, Yonsei University, 211 Eonguro, Gangnam-gu, Seoul, 06288, Republic of Korea.'}, {'ForeName': 'YuSik', 'Initials': 'Y', 'LastName': 'Kim', 'Affiliation': 'Severance Institute for Vascular and Metabolic Research, College of Medicine, Yonsei University, 211 Eonguro, Gangnam-gu, Seoul, 06288, Republic of Korea. Electronic address: cromoton@yuhs.ac.'}, {'ForeName': 'Ji Sun', 'Initials': 'JS', 'LastName': 'Nam', 'Affiliation': 'Department of Internal Medicine, Yonsei University College of Medicine, 63 gil 20, Eonguro, Gangnam-gu, Seoul, 06229, Republic of Korea; Severance Institute for Vascular and Metabolic Research, College of Medicine, Yonsei University, 211 Eonguro, Gangnam-gu, Seoul, 06288, Republic of Korea. Electronic address: jisunn@yuhs.ac.'}]",Archives of gerontology and geriatrics,['10.1016/j.archger.2020.104108'] 1983,32473365,Central nervous system activities of extract Mangifera indica L.,"ETHNOBOTANICAL RELEVANCE Leaves of Mangifera indica L. have folk-uses in tropical regions of the world as health teas, as a remedy for exhaustion and fatigue, as a vegetable, and as a medicine. Mangifera indica leaf extract (MLE) had previously been demonstrated to alter brain electrical activity in-vivo. The aim of the present series of studies was to investigate whether mangiferin, a major compound in leaves and in MLE, is responsible for the neurocognitive activity of MLE, and if the CNS activities of MLE have translational potential. MATERIALS AND METHODS MLE, tradename Zynamite, is produced by Nektium Pharma, Spain. Isolated mangiferin was tested in-vitro in radioligand binding and enzyme inhibition studies against 106 CNS targets. Changes in the electroencephalograms (EEG's) of MLE and mangiferin were recorded in-vivo from four brain regions. Two double blind randomized placebo-controlled crossover clinical trials were conducted, each with 16 subjects. At 90 min and at 60 min respectively, after oral intake of 500 mg MLE, EEG recordings, psychometric tests, mood state, and tolerability were studied. RESULTS Isolated mangiferin is a selective inhibitor of catechol-O-methyltransferase (COMT) with an IC50 of 1.1 μM, with no activity on the CNS targets of caffeine. Both mangiferin and MLE induce similar changes in long-term potentiation (LTP) in the hippocampus in-vitro, and induce a similar pattern of EEG changes in-vivo. In both translational clinical trials MLE was well tolerated, with no cardiovascular side-effects. In both studies MLE caused significant spectral changes in brain electrical activity in cortical regions during cognitive challenges, different to the attenuated spectral changes induced by caffeine. There were no significant changes in the psychometric tests other than reaction time for all groups. In the second study there was a trend to faster reaction time within group for MLE (p = 0.066) and the percentage improvement in reaction time for MLE compared to placebo was significant (p = 0.049). In the first study MLE improved all scores for Profile of Mood States (POMS), with the score for ""fatigue"" significantly improved (p = 0.015); in the second study the POMS score for ""dejection"" was improved in the caffeine group, p = 0.05. CONCLUSIONS Mangiferin is a COMT inhibitor of moderate potency and is the major CNS-active compound in MLE. Both mangiferin and MLE increase hippocampal LTP in-vitro, and induce a similar pattern of changes in brain electrical activity in-vivo. While the translational clinical trials of MLE are limited by being single dose studies in a small number of subjects, they provide the first clinical evidence that the extract is well tolerated with no cardiovascular side-effects, can induce changes in brain electrical activity, may give a faster reaction time, and decrease fatigue. These CNS activities support the reported folk-uses use of mango leaf tea as a substitute for tea and as a traditional remedy for fatigue and exhaustion. Extract Mangifera indica L., Zynamite, has nootropic potential, and larger clinical studies are needed to realise this potential.",2020,"Both mangiferin and MLE induce similar changes in long term potentiation (LTP) in the hippocampus in-vitro, and induce a similar pattern of EEG changes in-vivo.",['16 subjects'],"['Mangifera indica leaf extract (MLE', 'caffeine', 'mangiferin and MLE', 'MLE', 'extract Mangifera indica L', 'placebo']","['fatigue', 'POMS score for ""dejection', 'Profile of Mood States (POMS', 'brain electrical activity', 'psychometric tests, mood state, and tolerability', 'reaction time for MLE', 'faster reaction time']",[],"[{'cui': 'C4081111', 'cui_str': 'mango leaf extract'}, {'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C0065654', 'cui_str': 'mangiferin'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0330955', 'cui_str': 'Mangifera indica'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0451394', 'cui_str': 'Profile of mood states'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0234388', 'cui_str': 'Electrical activity of brain'}, {'cui': 'C0033920', 'cui_str': 'Psychometric testing'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C4081111', 'cui_str': 'mango leaf extract'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}]",,0.0364453,"Both mangiferin and MLE induce similar changes in long term potentiation (LTP) in the hippocampus in-vitro, and induce a similar pattern of EEG changes in-vivo.","[{'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'López-Ríos', 'Affiliation': 'Department of Research, Development and Innovation, Nektium Pharma SL, 35118, Las Palmas de Gran Canaria, Spain. Electronic address: llopez@nektium.com.'}, {'ForeName': 'Julia C', 'Initials': 'JC', 'LastName': 'Wiebe', 'Affiliation': 'Department of Research, Development and Innovation, Nektium Pharma SL, 35118, Las Palmas de Gran Canaria, Spain. Electronic address: jwiebe@nektium.com.'}, {'ForeName': 'Tanausú', 'Initials': 'T', 'LastName': 'Vega-Morales', 'Affiliation': 'Department of Research, Development and Innovation, Nektium Pharma SL, 35118, Las Palmas de Gran Canaria, Spain. Electronic address: tvega@nektium.com.'}, {'ForeName': 'Nigel', 'Initials': 'N', 'LastName': 'Gericke', 'Affiliation': 'Department of Research, Development and Innovation, Nektium Pharma SL, 35118, Las Palmas de Gran Canaria, Spain; Department of Botany and Plant Biotechnology, University of Johannesburg, Auckland Park, 2006, Johannesburg, South Africa. Electronic address: ngericke@nektium.com.'}]",Journal of ethnopharmacology,['10.1016/j.jep.2020.112996'] 1984,32473403,Testing a self-directed lifestyle intervention among veterans: The D-ELITE pragmatic clinical trial.,"Nearly half of Veterans have obesity, fueling chronic diseases. The Department of Veterans Affairs (VA) offers an evidence-based behavioral weight management intervention called MOVE!, mostly delivered through in-person group sessions. Few eligible Veterans participate due to factors like distance and preferences, mirroring barriers in the general population. Practical alternatives to standard in-person programs are needed to improve access and engagement. A self-directed lifestyle intervention called D-ELITE-delivered through pre-recorded videos by DVD or online streaming-previously efficacious in a general primary care population, may provide such an alternative. This pragmatic clinical trial will evaluate whether D-ELITE improves weight and general health status among Veterans with obesity, relative to VA usual care. The yearlong intervention includes one orientation by phone, supplemental lifestyle coaching primarily via technology-based messages, 12 DVD or online streaming sessions over 3 months, and continued self-directed weight management for months 4-12. Participants use MyFitnessPal.com or paper booklets for self-monitoring weight, diet, and physical activity. Follow-up assessments at 12 and 24 months are administered by mail or phone. The study hypothesis is that compared with usual care, D-ELITE will lead to greater improvements in 12-month weight loss, per VA electronic health records, and general physical health status, assessed using the self-reported SF-12 physical composite score. We will also explore D-ELITE's effects on secondary biometric (e.g., HbA1c) and intermediate (e.g., diet) outcomes, reach, and budget impact. If effective, D-ELITE will offer a potentially scalable, low-cost alternative to VA's existing weight loss interventions by mitigating barriers presented by distance and technology.",2020,"If effective, D-ELITE will offer a potentially scalable, low-cost alternative to VA's existing weight loss interventions by mitigating barriers presented by distance and technology.","['veterans', 'Veterans with obesity, relative to VA usual care']","['supplemental lifestyle coaching primarily via technology-based messages, 12 DVD or online streaming sessions', 'self-directed lifestyle intervention', 'self-directed lifestyle intervention called D-ELITE-delivered through pre-recorded videos by DVD or online streaming-previously efficacious']","['secondary biometric (e.g., HbA1c) and intermediate (e.g., diet) outcomes, reach, and budget impact', 'weight and general health status']","[{'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C3875154', 'cui_str': 'Relative to'}]","[{'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0557773', 'cui_str': 'Coach'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0750927', 'cui_str': 'Developmental verbal dyspraxia'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0042655', 'cui_str': 'Video'}]","[{'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0006347', 'cui_str': 'Budgets'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0424575', 'cui_str': 'General body state finding'}, {'cui': 'C0449438', 'cui_str': 'Status'}]",,0.02449,"If effective, D-ELITE will offer a potentially scalable, low-cost alternative to VA's existing weight loss interventions by mitigating barriers presented by distance and technology.","[{'ForeName': 'Katherine D', 'Initials': 'KD', 'LastName': 'Hoerster', 'Affiliation': 'VA Puget Sound Healthcare System, Seattle Division, Health Services Research and Development, 1660 South Columbian Way (S-152), Seattle, WA 98108, United States; VA Puget Sound Healthcare System, Seattle Division, Mental Health Service, 1660 South Columbian Way (S-116), Seattle, WA 98108, United States; University of Washington, Department of Psychiatry and Behavioral Sciences, 1100 NE 45(th) Street, Suite 300, Seattle, WA 98105, United States. Electronic address: Katherine.Hoerster@va.gov.'}, {'ForeName': 'Margaret P', 'Initials': 'MP', 'LastName': 'Collins', 'Affiliation': 'VA Puget Sound Healthcare System, Seattle Division, Health Services Research and Development, 1660 South Columbian Way (S-152), Seattle, WA 98108, United States. Electronic address: Margaret.Collins@va.gov.'}, {'ForeName': 'David H', 'Initials': 'DH', 'LastName': 'Au', 'Affiliation': 'VA Puget Sound Healthcare System, Seattle Division, Health Services Research and Development, 1660 South Columbian Way (S-152), Seattle, WA 98108, United States; University of Washington, Department of Medicine, 1959 NE Pacific St, Seattle, WA 98195, United States. Electronic address: David.Au@va.gov.'}, {'ForeName': 'Amber', 'Initials': 'A', 'LastName': 'Lane', 'Affiliation': 'VA Puget Sound Healthcare System, Seattle Division, Health Services Research and Development, 1660 South Columbian Way (S-152), Seattle, WA 98108, United States. Electronic address: Amber.Lane2@va.gov.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Epler', 'Affiliation': 'VA Puget Sound Healthcare System, Seattle Division, Health Services Research and Development, 1660 South Columbian Way (S-152), Seattle, WA 98108, United States. Electronic address: Eric.Epler@va.gov.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'McDowell', 'Affiliation': 'VA Puget Sound Healthcare System, Seattle Division, Health Services Research and Development, 1660 South Columbian Way (S-152), Seattle, WA 98108, United States. Electronic address: Jennifer.McDowell@va.gov.'}, {'ForeName': 'Anna E', 'Initials': 'AE', 'LastName': 'Barón', 'Affiliation': 'Department of Biostatistics and Informatics, Colorado School of Public Health, University of Colorado Anschutz Medical Campus, 13001 E. 17(th) Place, Aurora, CO 80045, United States. Electronic address: Anna.Baron@cuanschutz.edu.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Rise', 'Affiliation': 'VA Puget Sound Healthcare System, Seattle Division, Health Services Research and Development, 1660 South Columbian Way (S-152), Seattle, WA 98108, United States. Electronic address: Peter.Rise@va.gov.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Plumley', 'Affiliation': 'VA Puget Sound Healthcare System, Seattle Division, Health Services Research and Development, 1660 South Columbian Way (S-152), Seattle, WA 98108, United States. Electronic address: Robert.Plumley@va.gov.'}, {'ForeName': 'Tanya', 'Initials': 'T', 'LastName': 'Nguyen', 'Affiliation': 'VA Puget Sound Healthcare System, Seattle Division, Health Services Research and Development, 1660 South Columbian Way (S-152), Seattle, WA 98108, United States. Electronic address: Tanya.Nguyen@va.gov.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Schooler', 'Affiliation': 'VA Puget Sound Healthcare System, Seattle Division, Health Services Research and Development, 1660 South Columbian Way (S-152), Seattle, WA 98108, United States. Electronic address: Mary.Schooler@va.gov.'}, {'ForeName': 'Linnaea', 'Initials': 'L', 'LastName': 'Schuttner', 'Affiliation': 'VA Puget Sound Healthcare System, Seattle Division, Health Services Research and Development, 1660 South Columbian Way (S-152), Seattle, WA 98108, United States; University of Washington, Department of Medicine, 1959 NE Pacific St, Seattle, WA 98195, United States. Electronic address: Linnaea.Schuttner@va.gov.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Ma', 'Affiliation': 'University of Illinois at Chicago, Department of Medicine, 1747 W. Roosevelt Rd, Room 586 (MC 275), Chicago, IL 60608, United States. Electronic address: maj2015@uic.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106045'] 1985,32474062,The effects on ovarian activity of delaying versus immediately restarting combined oral contraception after missing three pills and taking ulipristal acetate 30 mg.,"OBJECTIVE Among combined oral contraception (COC) users, to determine the effect on ovarian activity and ovulation of waiting five days before restarting COC, versus restarting immediately, having taken ulipristal acetate 30 mg (UPA, the dose used for emergency contraception) after missing three consecutive COC pills. STUDY DESIGN Women already using COC were enrolled for two cycles of COC use (21/7 regimen). In cycle 2, all women omitted COC pills for three consecutive days (days 5,6,7), and on day 8 took UPA 30 mg. They were randomized either to restart their COC pills that same day (immediate restart) or to wait five days (delayed restart). Transvaginal ultrasound, and blood sampling for estradiol and progesterone were undertaken on days 4,8,11,13,15,18,22 and 26. A modified Hoogland score was used to quantify ovarian activity/ovulation and to assess whether luteal phase progesterone concentrations were sufficiently 'adequate' to have conferred a theoretical risk of pregnancy. RESULTS No one ovulated with risk of pregnancy during the five days following UPA. Among 26 women with immediate restart, none ovulated with a theoretical risk of pregnancy at any time in the cycle. Four of 23 women (17.4% CI [5.0; 38.8]) with delayed restart ovulated with theoretical risk of pregnancy before the end of the cycle. This difference was statistically significant (p = 0.042). CONCLUSION Women who delay restarting COC for five days after taking UPA 30 mg are at much greater risk of ovulation, and therefore theoretically of pregnancy, than if they restart their COC on the same day as taking UPA. Current recommendations should be revisited. IMPLICATIONS Women who take UPA-EC after having missed combined oral contraceptive pills are advised to wait five days before restarting the COC. This delay puts them at risk of ovulation and, if intercourse occurs, theoretically therefore of pregnancy. Women who restart their COC pills immediately are much less likely to ovulate. The label for UPA-EC and clinical guidelines on using EC after missed pills should be revisited.",2020,"Among 26 women with immediate restart, none ovulated with a theoretical risk of pregnancy at any time in the cycle.","['Women who delay restarting COC for five after taking', 'Women already using COC were enrolled for two cycles of COC use (21/7 regimen', '26 women with immediate restart, none ovulated with a theoretical risk of pregnancy at any time in the cycle']","['UPA', 'combined oral contraception (COC']","['ovarian activity', 'Transvaginal ultrasound, and blood sampling for estradiol and progesterone', 'risk of ovulation']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0700589', 'cui_str': 'Contraception'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C4546343', 'cui_str': 'Uses contraception'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0029965', 'cui_str': 'Ovulation'}, {'cui': 'C0404588', 'cui_str': 'Finding related to risk factor in pregnancy'}, {'cui': 'C0040223', 'cui_str': 'Time'}]","[{'cui': 'C0042071', 'cui_str': 'Urokinase'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0029151', 'cui_str': 'Oral contraception'}, {'cui': 'C0700589', 'cui_str': 'Contraception'}]","[{'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0203418', 'cui_str': 'Transvaginal echography'}, {'cui': 'C0005834', 'cui_str': 'Collection of blood specimen for laboratory'}, {'cui': 'C0014912', 'cui_str': 'Estradiol'}, {'cui': 'C0033308', 'cui_str': 'Progesterone'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0029965', 'cui_str': 'Ovulation'}]",26.0,0.105905,"Among 26 women with immediate restart, none ovulated with a theoretical risk of pregnancy at any time in the cycle.","[{'ForeName': 'Camille', 'Initials': 'C', 'LastName': 'Banh', 'Affiliation': 'HRA Pharma, 200 Avenue de Paris, 92320 Châtillon, France. Electronic address: c.banh@HRA-PHARMA.COM.'}, {'ForeName': 'Tanja', 'Initials': 'T', 'LastName': 'Rautenberg', 'Affiliation': 'Dinox GmbH, Anklamer Strasse 38, 10115 Berlin, Germany.'}, {'ForeName': 'Ingrid', 'Initials': 'I', 'LastName': 'Duijkers', 'Affiliation': 'Dinox Consultancy, Marktstraat 19, 9712 PB Groningen, the Netherlands.'}, {'ForeName': 'Pascale', 'Initials': 'P', 'LastName': 'Borenzstein', 'Affiliation': 'HRA Pharma, 200 Avenue de Paris, 92320 Châtillon, France.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Monteil', 'Affiliation': 'HRA Pharma, 200 Avenue de Paris, 92320 Châtillon, France.'}, {'ForeName': 'Delphine', 'Initials': 'D', 'LastName': 'Levy-Gompel', 'Affiliation': 'HRA Pharma, 200 Avenue de Paris, 92320 Châtillon, France.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Klipping', 'Affiliation': 'Dinox GmbH, Anklamer Strasse 38, 10115 Berlin, Germany.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Scherrer', 'Affiliation': 'Bruno Scherrer Conseil, 78730 Saint-Arnoult-en-Yvelines, France.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Glasier', 'Affiliation': ""Department of Obstetrics and Gynaecology, University of Edinburgh, Queen's Medical Research Institute, 47 Little France Crescent, Midlothian EH16 4TJ, UK.""}]",Contraception,['10.1016/j.contraception.2020.05.013'] 1986,32474130,Randomized controlled trial protocol for project BRIDGE: A telephone-administered motivational interviewing intervention targeting risky sexual behavior in older people living with HIV.,"PURPOSE By 2020, 70% of people living with HIV in the United States will be greater than 50 years of age. As many as 37% of sexually active older people living with HIV (OPLWH) engage in HIV transmission sexual behaviors. In spite of repeated calls for secondary prevention interventions to reduce condomless sex in OPLWH, no age-appropriate, evidence-based secondary prevention interventions exist for this group. Furthermore, many OPLWH face barriers to engaging in face-to-face secondary prevention services because of HIV- and age-related stigma, comorbid mental and physical health conditions that complicate travel, or geographic isolation. High rates of depression in OPLWH may further complicate engagement in interventions intended to reduce HIV transmissions. Telephone-administered motivational interviewing may be a feasible and efficacious intervention for this population. METHODS This randomized controlled trial will test the efficacy of a 5-session telephone-administered motivational interviewing plus behavioral skills training (teleMI+BST) intervention versus a 5-session telephone-administered coping effectiveness training (teleCET) control intervention to reduce condomless sex in OPLWH. A diverse sample of 336 OPLWH will be recruited across the U.S. The primary analysis will test the efficacy of teleMI+BST to reduce occasions of non-condom protected anal and vaginal intercourse with HIV serodiscordant sex partners. Secondary analyses will examine the efficacy of teleMI+BST to reduce depressive symptoms in mildly depressed OPLWH. CONCLUSION This is the first large-scale RCT intended to reduce HIV sexual transmission risk behavior in OPLWH and will add to the literature on secondary prevention telehealth interventions for people living with HIV. ClinicalTrials.gov Identifier: NCT03004170. This trial has been conducted by the approval of the Institutional Review Board. Participants provided verbal consent to participate in this trial.",2020,The primary analysis will test the efficacy of teleMI+BST to reduce occasions of non-condom protected anal and vaginal intercourse with HIV serodiscordant sex partners.,"['older people living with HIV', 'people living with HIV', 'A diverse sample of 336 OPLWH will be recruited across the U.S']","['teleMI+BST', 'Telephone-administered motivational interviewing', '5-session telephone-administered motivational interviewing plus behavioral skills training (teleMI+BST) intervention versus a 5-session telephone-administered coping effectiveness training (teleCET) control intervention', 'telephone-administered motivational interviewing intervention']",['depressive symptoms'],"[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}]","[{'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0559197', 'cui_str': 'Skills training'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]",336.0,0.216379,The primary analysis will test the efficacy of teleMI+BST to reduce occasions of non-condom protected anal and vaginal intercourse with HIV serodiscordant sex partners.,"[{'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Kahler', 'Affiliation': 'Center to Improve Veteran Involvement in Care, VA Portland Healthcare System, 3710 SW US Veterans Hospital Road, Portland, OR 97239, USA.'}, {'ForeName': 'Timothy G', 'Initials': 'TG', 'LastName': 'Heckman', 'Affiliation': 'College of Public Health, University of Georgia, 100 Foster Road, Athens, GA 30606, USA.'}, {'ForeName': 'Ye', 'Initials': 'Y', 'LastName': 'Shen', 'Affiliation': 'College of Public Health, University of Georgia, 100 Foster Road, Athens, GA 30606, USA.'}, {'ForeName': 'Marilyn S', 'Initials': 'MS', 'LastName': 'Huckans', 'Affiliation': 'Department of Psychiatry, Oregon Health & Science University, 3181 SW Sam Jackson Park Road, Portland, OR 97239, USA.'}, {'ForeName': 'Sarah W', 'Initials': 'SW', 'LastName': 'Feldstein Ewing', 'Affiliation': 'Department of Psychiatry, Oregon Health & Science University, 3181 SW Sam Jackson Park Road, Portland, OR 97239, USA.'}, {'ForeName': 'Jeffrey T', 'Initials': 'JT', 'LastName': 'Parsons', 'Affiliation': 'Mindful Designs, 791 Salem Street, Teaneck, NJ 07666, USA.'}, {'ForeName': 'Alissa', 'Initials': 'A', 'LastName': 'Phelps', 'Affiliation': 'Center to Improve Veteran Involvement in Care, VA Portland Healthcare System, 3710 SW US Veterans Hospital Road, Portland, OR 97239, USA; Department of Psychiatry, Oregon Health & Science University, 3181 SW Sam Jackson Park Road, Portland, OR 97239, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Sutton', 'Affiliation': 'College of Public Health, University of Georgia, 100 Foster Road, Athens, GA 30606, USA.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Holloway', 'Affiliation': 'Center to Improve Veteran Involvement in Care, VA Portland Healthcare System, 3710 SW US Veterans Hospital Road, Portland, OR 97239, USA; Department of Psychiatry, Oregon Health & Science University, 3181 SW Sam Jackson Park Road, Portland, OR 97239, USA.'}, {'ForeName': 'Travis I', 'Initials': 'TI', 'LastName': 'Lovejoy', 'Affiliation': 'Center to Improve Veteran Involvement in Care, VA Portland Healthcare System, 3710 SW US Veterans Hospital Road, Portland, OR 97239, USA; Department of Psychiatry, Oregon Health & Science University, 3181 SW Sam Jackson Park Road, Portland, OR 97239, USA. Electronic address: lovejoy@ohsu.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106047'] 1987,32485323,Moderators of treatment effects in a child maltreatment prevention programme in South Africa.,"BACKGROUND Previous research has found mixed results on whether the most disadvantaged families benefit as much as less disadvantaged families from parenting interventions designed to reduce child maltreatment, and little in known in low-income settings. OBJECTIVE In this study, we test the effects of child, caregiver, household, and community characteristics as treatment moderators of intervention outcomes - child maltreatment and parenting practices. We test characteristics previously examined elsewhere as well as factors relevant to the South African context. PARTICIPANTS AND SETTING This analysis includes adolescents (ages 10-18) and their caregivers (N = 552 pairs) who participated in a randomised trial of a parenting programme in the Eastern Cape Province of South Africa. METHODS Data from the caregiver and adolescent standardised questionnaires collected at baseline, post-test (1-month post-intervention), and follow-up (5-9 months) were analysed using longitudinal multilevel analyses. We tested seven hypothesised moderators for each of the primary outcomes through interactions of treatment effect with baseline moderators. RESULTS No moderator effects were statistically significant after correcting for multiple comparisons testing. Hence, in line with several recent studies examining moderation effects in parenting programmes, our study suggests that parenting interventions aiming to reduce child maltreatment and promote parenting skills in low- and middle-income countries may be similarly effective for families facing various levels of economic, social, and health risk factors. CONCLUSIONS It may be useful to explicitly power trials for testing moderator effects, study different types of moderators and use person-centred analyses to further understand variations in treatment effects.",2020,No moderator effects were statistically significant after correcting for multiple comparisons testing.,"['This analysis includes adolescents (ages 10-18) and their caregivers (N = 552 pairs) who participated in a randomised trial of a parenting programme in the Eastern Cape Province of South Africa', 'Data from the caregiver and adolescent standardised questionnaires collected at baseline, post-test (1-month post-intervention), and follow-up (5-9 months) were analysed using longitudinal multilevel analyses', 'child maltreatment prevention programme in South Africa']",[],[],"[{'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0454728', 'cui_str': 'Cape Province'}, {'cui': 'C0037712', 'cui_str': 'South Africa'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0205127', 'cui_str': 'Longitudinal'}, {'cui': 'C0814909', 'cui_str': 'Multilevel Analysis'}, {'cui': 'C0008060', 'cui_str': 'Child abuse'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}]",[],[],552.0,0.117227,No moderator effects were statistically significant after correcting for multiple comparisons testing.,"[{'ForeName': 'Yulia', 'Initials': 'Y', 'LastName': 'Shenderovich', 'Affiliation': 'Department of Social Policy and Intervention, Centre for Evidence-Based Intervention, University of Oxford, Barnett House, 32 Wellington Square, OX1 2ER, Oxford, United Kingdom; Institute of Criminology, University of Cambridge, Sidgwick Avenue, CB3 9DA, Cambridge, United Kingdom. Electronic address: yulia.shenderovich@spi.ox.ac.uk.'}, {'ForeName': 'Lucie', 'Initials': 'L', 'LastName': 'Cluver', 'Affiliation': 'Department of Social Policy and Intervention, Centre for Evidence-Based Intervention, University of Oxford, Barnett House, 32 Wellington Square, OX1 2ER, Oxford, United Kingdom; Department of Psychiatry and Mental Health, University of Cape Town, J-Block, Groote Schuur Hospital, Observatory, 7925, Cape Town, South Africa. Electronic address: lucie.cluver@spi.ox.ac.uk.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Eisner', 'Affiliation': 'Institute of Criminology, University of Cambridge, Sidgwick Avenue, CB3 9DA, Cambridge, United Kingdom; Jacobs Center for Productive Youth Development, University of Zurich, Andreasstrasse 15, 8050, Zürich, Switzerland. Electronic address: mpe23@cam.ac.uk.'}, {'ForeName': 'Aja Louise', 'Initials': 'AL', 'LastName': 'Murray', 'Affiliation': 'Institute of Criminology, University of Cambridge, Sidgwick Avenue, CB3 9DA, Cambridge, United Kingdom; Department of Psychology, University of Edinburgh, Room F16, Psychology Building, 7 George Square, Edinburgh, EH8 9JZ, United Kingdom. Electronic address: Aja.Murray@ed.ac.uk.'}]",Child abuse & neglect,['10.1016/j.chiabu.2020.104519'] 1988,32485422,Utilizing the somatosensory system via vibratory stimulation to mitigate knee pain during walking: Randomized clinical trial.,"BACKGROUND Pain and proprioception deficits are often associated with knee pathologies and resultant quadriceps muscle inhibition. There is a need for new approaches to mitigate active knee pain and restore muscle function during walking. Activating properties of the somatosensory system with common pain and sensory pathways offers a novel opportunity to enhance quadriceps function during walking. RESEARCH QUESTION Conduct a controlled clinical trial that investigates the effects of applying intermittent vibrational cutaneous stimulation during walking on knee pain and symptoms and their correlations to gait parameters. METHODS This longitudinal controlled cross-over clinical study included thirty-two patients randomly and blindly assigned to active Treatment A and passive Treatment B for 4 weeks with a 2-week washout period between treatments. RESULTS Subjects when wearing active Treatment A for 4 weeks had significant (p = 0.04) improvement in patient reported outcomes, while they had no significant differences with passive Treatment B (p > 0.7) compared to the no treatment condition. For Treatment A, subjects with low knee flexion moment and knee flexion angle in no-treatment condition exhibited the greatest increase in knee flexion moment/angle in the active treatment condition (R > 0.57, p < 0.001). These changes in gait measures were correlated significantly to changes in pain. SIGNIFICANCE This clinical trial indicates that knee pain can be reduced, and gait improved in a manner that enhances quadriceps function by applying intermittent cutaneous stimulation during gait in patients following knee injury or disease. The correlation between decreased pain and improved gait suggests that rehabilitation and exercise therapy may benefit from this treatment.",2020,"RESULTS Subjects when wearing active Treatment A for 4 weeks had significant (p = 0.04) improvement in patient reported outcomes, while they had no significant differences with passive Treatment B (p > 0.7) compared to the no treatment condition.",['knee pain during walking'],"['somatosensory system via vibratory stimulation', 'intermittent vibrational cutaneous stimulation']","['knee flexion moment/angle', 'gait measures', 'pain']","[{'cui': 'C0231749', 'cui_str': 'Knee pain'}]","[{'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0150184', 'cui_str': 'Cutaneous stimulation'}]","[{'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",32.0,0.0771875,"RESULTS Subjects when wearing active Treatment A for 4 weeks had significant (p = 0.04) improvement in patient reported outcomes, while they had no significant differences with passive Treatment B (p > 0.7) compared to the no treatment condition.","[{'ForeName': 'Arielle G', 'Initials': 'AG', 'LastName': 'Fischer', 'Affiliation': 'BioMotion Laboratory, Department of Mechanical Engineering, Stanford University, Stanford, CA 94305, USA. Electronic address: ariellef@stanford.edu.'}, {'ForeName': 'Jennifer C', 'Initials': 'JC', 'LastName': 'Erhart-Hledik', 'Affiliation': 'BioMotion Laboratory, Department of Mechanical Engineering, Stanford University, Stanford, CA 94305, USA; Palo Alto Veterans Hospital, Palo Alto, CA, USA.'}, {'ForeName': 'Jessica L', 'Initials': 'JL', 'LastName': 'Asay', 'Affiliation': 'BioMotion Laboratory, Department of Mechanical Engineering, Stanford University, Stanford, CA 94305, USA; Palo Alto Veterans Hospital, Palo Alto, CA, USA.'}, {'ForeName': 'Constance R', 'Initials': 'CR', 'LastName': 'Chu', 'Affiliation': 'BioMotion Laboratory, Department of Mechanical Engineering, Stanford University, Stanford, CA 94305, USA; Palo Alto Veterans Hospital, Palo Alto, CA, USA.'}, {'ForeName': 'Thomas P', 'Initials': 'TP', 'LastName': 'Andriacchi', 'Affiliation': 'BioMotion Laboratory, Department of Mechanical Engineering, Stanford University, Stanford, CA 94305, USA.'}]",Gait & posture,['10.1016/j.gaitpost.2020.05.030'] 1989,32579810,Serum Urate Lowering with Allopurinol and Kidney Function in Type 1 Diabetes.,"BACKGROUND Higher serum urate levels are associated with an increased risk of diabetic kidney disease. Lowering of the serum urate level with allopurinol may slow the decrease in the glomerular filtration rate (GFR) in persons with type 1 diabetes and early-to-moderate diabetic kidney disease. METHODS In a double-blind trial, we randomly assigned participants with type 1 diabetes, a serum urate level of at least 4.5 mg per deciliter, an estimated GFR of 40.0 to 99.9 ml per minute per 1.73 m 2 of body-surface area, and evidence of diabetic kidney disease to receive allopurinol or placebo. The primary outcome was the baseline-adjusted GFR, as measured with iohexol, after 3 years plus a 2-month washout period. Secondary outcomes included the decrease in the iohexol-based GFR per year and the urinary albumin excretion rate after washout. Safety was also assessed. RESULTS A total of 267 patients were assigned to receive allopurinol and 263 to receive placebo. The mean age was 51.1 years, the mean duration of diabetes 34.6 years, and the mean glycated hemoglobin level 8.2%. The mean baseline iohexol-based GFR was 68.7 ml per minute per 1.73 m 2 in the allopurinol group and 67.3 ml per minute per 1.73 m 2 in the placebo group. During the intervention period, the mean serum urate level decreased from 6.1 to 3.9 mg per deciliter with allopurinol and remained at 6.1 mg per deciliter with placebo. After washout, the between-group difference in the mean iohexol-based GFR was 0.001 ml per minute per 1.73 m 2 (95% confidence interval [CI], -1.9 to 1.9; P = 0.99). The mean decrease in the iohexol-based GFR was -3.0 ml per minute per 1.73 m 2 per year with allopurinol and -2.5 ml per minute per 1.73 m 2 per year with placebo (between-group difference, -0.6 ml per minute per 1.73 m 2 per year; 95% CI, -1.5 to 0.4). The mean urinary albumin excretion rate after washout was 40% (95% CI, 0 to 80) higher with allopurinol than with placebo. The frequency of serious adverse events was similar in the two groups. CONCLUSIONS We found no evidence of clinically meaningful benefits of serum urate reduction with allopurinol on kidney outcomes among patients with type 1 diabetes and early-to-moderate diabetic kidney disease. (Funded by the National Institute of Diabetes and Digestive and Kidney Diseases and others; PERL ClinicalTrials.gov number, NCT02017171.).",2020,"The mean urinary albumin excretion rate after washout was 40% (95% CI, 0 to 80) higher with allopurinol than with placebo.","['persons with type 1 diabetes and early-to-moderate diabetic kidney disease', 'Type 1 Diabetes', 'patients with type 1 diabetes and early-to-moderate diabetic kidney disease', '267 patients']","['placebo', 'allopurinol or placebo', 'allopurinol', 'Allopurinol']","['Safety', 'frequency of serious adverse events', 'baseline-adjusted GFR', 'iohexol-based GFR per year and the urinary albumin excretion rate', 'mean baseline iohexol-based GFR', 'mean serum urate level', 'iohexol-based GFR', 'kidney outcomes', 'mean urinary albumin excretion rate', 'mean iohexol-based GFR', 'glomerular filtration rate (GFR']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0011881', 'cui_str': 'Kidney disorder due to diabetes mellitus'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517672', 'cui_str': '267'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0002144', 'cui_str': 'Allopurinol'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0022005', 'cui_str': 'Iohexol'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0439508', 'cui_str': '/year'}, {'cui': 'C0585937', 'cui_str': 'Albumin excretion rate measurement'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0455272', 'cui_str': 'Serum urate measurement'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",267.0,0.615998,"The mean urinary albumin excretion rate after washout was 40% (95% CI, 0 to 80) higher with allopurinol than with placebo.","[{'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Doria', 'Affiliation': 'From the Research Division, Joslin Diabetes Center, and the Department of Medicine, Harvard Medical School, Boston (A.D., A.B.G., S.E.R.); the Division of Geriatrics, Institute of Gerontology (A.T.G., C.W.), the Department of Biostatistics, School of Public Health (A.T.G., C.S.), Statistical Analysis of Biomedical and Educational Research (SABER) (C.S.), and the Department of Internal Medicine, Metabolism, Endocrinology, and Diabetes (R.P.-B.), University of Michigan, Ann Arbor; the Departments of Medicine, Physiology, and Pharmacology and Toxicology (D.Z.C.) and the Division of Endocrinology and Metabolism (B.A.P.), University of Toronto, the Division of Nephrology, University Health Network (D.Z.C.), LMC Diabetes and Endocrinology (R.A.), and Lunenfeld-Tanenbaum Research Institute, Sinai Health System (B.A.P.), Toronto, the Departments of Medicine, Cardiac Sciences, and Community Health Sciences, Faculties of Medicine and Kinesiology, University of Calgary, Calgary, AB (R.J.S.), BCDiabetes, Vancouver (T.G.E.), and the Division of Endocrinology, University of Alberta, Edmonton (P.S.) - all in Canada; the Departments of Medicine and Population and Data Sciences, University of Texas Southwestern Medical Center, Dallas (I.L.); the Division of Kidney, Urologic, and Hematologic Diseases, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD (A.P.); Steno Diabetes Center, and the Department of Clinical Medicine, University Copenhagen, Copenhagen (P.R.); the Division of Nephrology, Department of Medicine, University of California, Davis (M.A.), and the Department of Pediatrics and Stanford Diabetes Research Center, Stanford University, Palo Alto (D.M.M.) - both in California; the Departments of Medicine and Pediatrics (M.L.C., W.N.R.. M.M.) and Laboratory Medicine and Pathology (A.B.K.), University of Minnesota, Minneapolis; the Division of Endocrinology and Fleischer Institute for Diabetes and Metabolism, Albert Einstein College of Medicine (J.P.C.), and JDRF (Juvenile Diabetes Research Foundation) (M.P.), New York; the Department of Medicine (I.H.B., I.B.H.) and the Nephrology Division (K.R.T.), University of Washington, and the Institute of Translational Health Sciences, Kidney Research Institute (K.R.T.), Seattle, and Providence Health Care, Spokane (K.R.T.) - both in Washington; the Department of Medicine, Emory University, Atlanta (J.S.H., G.E.U.); the Division of Endocrinology, Metabolism, and Lipid Research, Washington University School of Medicine, St. Louis (J.B.M.); the Division of Endocrinology, Metabolism, and Molecular Medicine, Northwestern University Feinberg School of Medicine, Chicago (M.E.M., A.W.); the Barbara Davis Center for Diabetes, University of Colorado, Aurora (S.P.); and the Department of Medicine, State University of New York Upstate Medical University, Syracuse (R.S.W.).'}, {'ForeName': 'Andrzej T', 'Initials': 'AT', 'LastName': 'Galecki', 'Affiliation': 'From the Research Division, Joslin Diabetes Center, and the Department of Medicine, Harvard Medical School, Boston (A.D., A.B.G., S.E.R.); the Division of Geriatrics, Institute of Gerontology (A.T.G., C.W.), the Department of Biostatistics, School of Public Health (A.T.G., C.S.), Statistical Analysis of Biomedical and Educational Research (SABER) (C.S.), and the Department of Internal Medicine, Metabolism, Endocrinology, and Diabetes (R.P.-B.), University of Michigan, Ann Arbor; the Departments of Medicine, Physiology, and Pharmacology and Toxicology (D.Z.C.) and the Division of Endocrinology and Metabolism (B.A.P.), University of Toronto, the Division of Nephrology, University Health Network (D.Z.C.), LMC Diabetes and Endocrinology (R.A.), and Lunenfeld-Tanenbaum Research Institute, Sinai Health System (B.A.P.), Toronto, the Departments of Medicine, Cardiac Sciences, and Community Health Sciences, Faculties of Medicine and Kinesiology, University of Calgary, Calgary, AB (R.J.S.), BCDiabetes, Vancouver (T.G.E.), and the Division of Endocrinology, University of Alberta, Edmonton (P.S.) - all in Canada; the Departments of Medicine and Population and Data Sciences, University of Texas Southwestern Medical Center, Dallas (I.L.); the Division of Kidney, Urologic, and Hematologic Diseases, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD (A.P.); Steno Diabetes Center, and the Department of Clinical Medicine, University Copenhagen, Copenhagen (P.R.); the Division of Nephrology, Department of Medicine, University of California, Davis (M.A.), and the Department of Pediatrics and Stanford Diabetes Research Center, Stanford University, Palo Alto (D.M.M.) - both in California; the Departments of Medicine and Pediatrics (M.L.C., W.N.R.. M.M.) and Laboratory Medicine and Pathology (A.B.K.), University of Minnesota, Minneapolis; the Division of Endocrinology and Fleischer Institute for Diabetes and Metabolism, Albert Einstein College of Medicine (J.P.C.), and JDRF (Juvenile Diabetes Research Foundation) (M.P.), New York; the Department of Medicine (I.H.B., I.B.H.) and the Nephrology Division (K.R.T.), University of Washington, and the Institute of Translational Health Sciences, Kidney Research Institute (K.R.T.), Seattle, and Providence Health Care, Spokane (K.R.T.) - both in Washington; the Department of Medicine, Emory University, Atlanta (J.S.H., G.E.U.); the Division of Endocrinology, Metabolism, and Lipid Research, Washington University School of Medicine, St. Louis (J.B.M.); the Division of Endocrinology, Metabolism, and Molecular Medicine, Northwestern University Feinberg School of Medicine, Chicago (M.E.M., A.W.); the Barbara Davis Center for Diabetes, University of Colorado, Aurora (S.P.); and the Department of Medicine, State University of New York Upstate Medical University, Syracuse (R.S.W.).'}, {'ForeName': 'Cathie', 'Initials': 'C', 'LastName': 'Spino', 'Affiliation': 'From the Research Division, Joslin Diabetes Center, and the Department of Medicine, Harvard Medical School, Boston (A.D., A.B.G., S.E.R.); the Division of Geriatrics, Institute of Gerontology (A.T.G., C.W.), the Department of Biostatistics, School of Public Health (A.T.G., C.S.), Statistical Analysis of Biomedical and Educational Research (SABER) (C.S.), and the Department of Internal Medicine, Metabolism, Endocrinology, and Diabetes (R.P.-B.), University of Michigan, Ann Arbor; the Departments of Medicine, Physiology, and Pharmacology and Toxicology (D.Z.C.) and the Division of Endocrinology and Metabolism (B.A.P.), University of Toronto, the Division of Nephrology, University Health Network (D.Z.C.), LMC Diabetes and Endocrinology (R.A.), and Lunenfeld-Tanenbaum Research Institute, Sinai Health System (B.A.P.), Toronto, the Departments of Medicine, Cardiac Sciences, and Community Health Sciences, Faculties of Medicine and Kinesiology, University of Calgary, Calgary, AB (R.J.S.), BCDiabetes, Vancouver (T.G.E.), and the Division of Endocrinology, University of Alberta, Edmonton (P.S.) - all in Canada; the Departments of Medicine and Population and Data Sciences, University of Texas Southwestern Medical Center, Dallas (I.L.); the Division of Kidney, Urologic, and Hematologic Diseases, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD (A.P.); Steno Diabetes Center, and the Department of Clinical Medicine, University Copenhagen, Copenhagen (P.R.); the Division of Nephrology, Department of Medicine, University of California, Davis (M.A.), and the Department of Pediatrics and Stanford Diabetes Research Center, Stanford University, Palo Alto (D.M.M.) - both in California; the Departments of Medicine and Pediatrics (M.L.C., W.N.R.. M.M.) and Laboratory Medicine and Pathology (A.B.K.), University of Minnesota, Minneapolis; the Division of Endocrinology and Fleischer Institute for Diabetes and Metabolism, Albert Einstein College of Medicine (J.P.C.), and JDRF (Juvenile Diabetes Research Foundation) (M.P.), New York; the Department of Medicine (I.H.B., I.B.H.) and the Nephrology Division (K.R.T.), University of Washington, and the Institute of Translational Health Sciences, Kidney Research Institute (K.R.T.), Seattle, and Providence Health Care, Spokane (K.R.T.) - both in Washington; the Department of Medicine, Emory University, Atlanta (J.S.H., G.E.U.); the Division of Endocrinology, Metabolism, and Lipid Research, Washington University School of Medicine, St. Louis (J.B.M.); the Division of Endocrinology, Metabolism, and Molecular Medicine, Northwestern University Feinberg School of Medicine, Chicago (M.E.M., A.W.); the Barbara Davis Center for Diabetes, University of Colorado, Aurora (S.P.); and the Department of Medicine, State University of New York Upstate Medical University, Syracuse (R.S.W.).'}, {'ForeName': 'Rodica', 'Initials': 'R', 'LastName': 'Pop-Busui', 'Affiliation': 'From the Research Division, Joslin Diabetes Center, and the Department of Medicine, Harvard Medical School, Boston (A.D., A.B.G., S.E.R.); the Division of Geriatrics, Institute of Gerontology (A.T.G., C.W.), the Department of Biostatistics, School of Public Health (A.T.G., C.S.), Statistical Analysis of Biomedical and Educational Research (SABER) (C.S.), and the Department of Internal Medicine, Metabolism, Endocrinology, and Diabetes (R.P.-B.), University of Michigan, Ann Arbor; the Departments of Medicine, Physiology, and Pharmacology and Toxicology (D.Z.C.) and the Division of Endocrinology and Metabolism (B.A.P.), University of Toronto, the Division of Nephrology, University Health Network (D.Z.C.), LMC Diabetes and Endocrinology (R.A.), and Lunenfeld-Tanenbaum Research Institute, Sinai Health System (B.A.P.), Toronto, the Departments of Medicine, Cardiac Sciences, and Community Health Sciences, Faculties of Medicine and Kinesiology, University of Calgary, Calgary, AB (R.J.S.), BCDiabetes, Vancouver (T.G.E.), and the Division of Endocrinology, University of Alberta, Edmonton (P.S.) - all in Canada; the Departments of Medicine and Population and Data Sciences, University of Texas Southwestern Medical Center, Dallas (I.L.); the Division of Kidney, Urologic, and Hematologic Diseases, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD (A.P.); Steno Diabetes Center, and the Department of Clinical Medicine, University Copenhagen, Copenhagen (P.R.); the Division of Nephrology, Department of Medicine, University of California, Davis (M.A.), and the Department of Pediatrics and Stanford Diabetes Research Center, Stanford University, Palo Alto (D.M.M.) - both in California; the Departments of Medicine and Pediatrics (M.L.C., W.N.R.. M.M.) and Laboratory Medicine and Pathology (A.B.K.), University of Minnesota, Minneapolis; the Division of Endocrinology and Fleischer Institute for Diabetes and Metabolism, Albert Einstein College of Medicine (J.P.C.), and JDRF (Juvenile Diabetes Research Foundation) (M.P.), New York; the Department of Medicine (I.H.B., I.B.H.) and the Nephrology Division (K.R.T.), University of Washington, and the Institute of Translational Health Sciences, Kidney Research Institute (K.R.T.), Seattle, and Providence Health Care, Spokane (K.R.T.) - both in Washington; the Department of Medicine, Emory University, Atlanta (J.S.H., G.E.U.); the Division of Endocrinology, Metabolism, and Lipid Research, Washington University School of Medicine, St. Louis (J.B.M.); the Division of Endocrinology, Metabolism, and Molecular Medicine, Northwestern University Feinberg School of Medicine, Chicago (M.E.M., A.W.); the Barbara Davis Center for Diabetes, University of Colorado, Aurora (S.P.); and the Department of Medicine, State University of New York Upstate Medical University, Syracuse (R.S.W.).'}, {'ForeName': 'David Z', 'Initials': 'DZ', 'LastName': 'Cherney', 'Affiliation': 'From the Research Division, Joslin Diabetes Center, and the Department of Medicine, Harvard Medical School, Boston (A.D., A.B.G., S.E.R.); the Division of Geriatrics, Institute of Gerontology (A.T.G., C.W.), the Department of Biostatistics, School of Public Health (A.T.G., C.S.), Statistical Analysis of Biomedical and Educational Research (SABER) (C.S.), and the Department of Internal Medicine, Metabolism, Endocrinology, and Diabetes (R.P.-B.), University of Michigan, Ann Arbor; the Departments of Medicine, Physiology, and Pharmacology and Toxicology (D.Z.C.) and the Division of Endocrinology and Metabolism (B.A.P.), University of Toronto, the Division of Nephrology, University Health Network (D.Z.C.), LMC Diabetes and Endocrinology (R.A.), and Lunenfeld-Tanenbaum Research Institute, Sinai Health System (B.A.P.), Toronto, the Departments of Medicine, Cardiac Sciences, and Community Health Sciences, Faculties of Medicine and Kinesiology, University of Calgary, Calgary, AB (R.J.S.), BCDiabetes, Vancouver (T.G.E.), and the Division of Endocrinology, University of Alberta, Edmonton (P.S.) - all in Canada; the Departments of Medicine and Population and Data Sciences, University of Texas Southwestern Medical Center, Dallas (I.L.); the Division of Kidney, Urologic, and Hematologic Diseases, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD (A.P.); Steno Diabetes Center, and the Department of Clinical Medicine, University Copenhagen, Copenhagen (P.R.); the Division of Nephrology, Department of Medicine, University of California, Davis (M.A.), and the Department of Pediatrics and Stanford Diabetes Research Center, Stanford University, Palo Alto (D.M.M.) - both in California; the Departments of Medicine and Pediatrics (M.L.C., W.N.R.. M.M.) and Laboratory Medicine and Pathology (A.B.K.), University of Minnesota, Minneapolis; the Division of Endocrinology and Fleischer Institute for Diabetes and Metabolism, Albert Einstein College of Medicine (J.P.C.), and JDRF (Juvenile Diabetes Research Foundation) (M.P.), New York; the Department of Medicine (I.H.B., I.B.H.) and the Nephrology Division (K.R.T.), University of Washington, and the Institute of Translational Health Sciences, Kidney Research Institute (K.R.T.), Seattle, and Providence Health Care, Spokane (K.R.T.) - both in Washington; the Department of Medicine, Emory University, Atlanta (J.S.H., G.E.U.); the Division of Endocrinology, Metabolism, and Lipid Research, Washington University School of Medicine, St. Louis (J.B.M.); the Division of Endocrinology, Metabolism, and Molecular Medicine, Northwestern University Feinberg School of Medicine, Chicago (M.E.M., A.W.); the Barbara Davis Center for Diabetes, University of Colorado, Aurora (S.P.); and the Department of Medicine, State University of New York Upstate Medical University, Syracuse (R.S.W.).'}, {'ForeName': 'Ildiko', 'Initials': 'I', 'LastName': 'Lingvay', 'Affiliation': 'From the Research Division, Joslin Diabetes Center, and the Department of Medicine, Harvard Medical School, Boston (A.D., A.B.G., S.E.R.); the Division of Geriatrics, Institute of Gerontology (A.T.G., C.W.), the Department of Biostatistics, School of Public Health (A.T.G., C.S.), Statistical Analysis of Biomedical and Educational Research (SABER) (C.S.), and the Department of Internal Medicine, Metabolism, Endocrinology, and Diabetes (R.P.-B.), University of Michigan, Ann Arbor; the Departments of Medicine, Physiology, and Pharmacology and Toxicology (D.Z.C.) and the Division of Endocrinology and Metabolism (B.A.P.), University of Toronto, the Division of Nephrology, University Health Network (D.Z.C.), LMC Diabetes and Endocrinology (R.A.), and Lunenfeld-Tanenbaum Research Institute, Sinai Health System (B.A.P.), Toronto, the Departments of Medicine, Cardiac Sciences, and Community Health Sciences, Faculties of Medicine and Kinesiology, University of Calgary, Calgary, AB (R.J.S.), BCDiabetes, Vancouver (T.G.E.), and the Division of Endocrinology, University of Alberta, Edmonton (P.S.) - all in Canada; the Departments of Medicine and Population and Data Sciences, University of Texas Southwestern Medical Center, Dallas (I.L.); the Division of Kidney, Urologic, and Hematologic Diseases, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD (A.P.); Steno Diabetes Center, and the Department of Clinical Medicine, University Copenhagen, Copenhagen (P.R.); the Division of Nephrology, Department of Medicine, University of California, Davis (M.A.), and the Department of Pediatrics and Stanford Diabetes Research Center, Stanford University, Palo Alto (D.M.M.) - both in California; the Departments of Medicine and Pediatrics (M.L.C., W.N.R.. M.M.) and Laboratory Medicine and Pathology (A.B.K.), University of Minnesota, Minneapolis; the Division of Endocrinology and Fleischer Institute for Diabetes and Metabolism, Albert Einstein College of Medicine (J.P.C.), and JDRF (Juvenile Diabetes Research Foundation) (M.P.), New York; the Department of Medicine (I.H.B., I.B.H.) and the Nephrology Division (K.R.T.), University of Washington, and the Institute of Translational Health Sciences, Kidney Research Institute (K.R.T.), Seattle, and Providence Health Care, Spokane (K.R.T.) - both in Washington; the Department of Medicine, Emory University, Atlanta (J.S.H., G.E.U.); the Division of Endocrinology, Metabolism, and Lipid Research, Washington University School of Medicine, St. Louis (J.B.M.); the Division of Endocrinology, Metabolism, and Molecular Medicine, Northwestern University Feinberg School of Medicine, Chicago (M.E.M., A.W.); the Barbara Davis Center for Diabetes, University of Colorado, Aurora (S.P.); and the Department of Medicine, State University of New York Upstate Medical University, Syracuse (R.S.W.).'}, {'ForeName': 'Afshin', 'Initials': 'A', 'LastName': 'Parsa', 'Affiliation': 'From the Research Division, Joslin Diabetes Center, and the Department of Medicine, Harvard Medical School, Boston (A.D., A.B.G., S.E.R.); the Division of Geriatrics, Institute of Gerontology (A.T.G., C.W.), the Department of Biostatistics, School of Public Health (A.T.G., C.S.), Statistical Analysis of Biomedical and Educational Research (SABER) (C.S.), and the Department of Internal Medicine, Metabolism, Endocrinology, and Diabetes (R.P.-B.), University of Michigan, Ann Arbor; the Departments of Medicine, Physiology, and Pharmacology and Toxicology (D.Z.C.) and the Division of Endocrinology and Metabolism (B.A.P.), University of Toronto, the Division of Nephrology, University Health Network (D.Z.C.), LMC Diabetes and Endocrinology (R.A.), and Lunenfeld-Tanenbaum Research Institute, Sinai Health System (B.A.P.), Toronto, the Departments of Medicine, Cardiac Sciences, and Community Health Sciences, Faculties of Medicine and Kinesiology, University of Calgary, Calgary, AB (R.J.S.), BCDiabetes, Vancouver (T.G.E.), and the Division of Endocrinology, University of Alberta, Edmonton (P.S.) - all in Canada; the Departments of Medicine and Population and Data Sciences, University of Texas Southwestern Medical Center, Dallas (I.L.); the Division of Kidney, Urologic, and Hematologic Diseases, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD (A.P.); Steno Diabetes Center, and the Department of Clinical Medicine, University Copenhagen, Copenhagen (P.R.); the Division of Nephrology, Department of Medicine, University of California, Davis (M.A.), and the Department of Pediatrics and Stanford Diabetes Research Center, Stanford University, Palo Alto (D.M.M.) - both in California; the Departments of Medicine and Pediatrics (M.L.C., W.N.R.. M.M.) and Laboratory Medicine and Pathology (A.B.K.), University of Minnesota, Minneapolis; the Division of Endocrinology and Fleischer Institute for Diabetes and Metabolism, Albert Einstein College of Medicine (J.P.C.), and JDRF (Juvenile Diabetes Research Foundation) (M.P.), New York; the Department of Medicine (I.H.B., I.B.H.) and the Nephrology Division (K.R.T.), University of Washington, and the Institute of Translational Health Sciences, Kidney Research Institute (K.R.T.), Seattle, and Providence Health Care, Spokane (K.R.T.) - both in Washington; the Department of Medicine, Emory University, Atlanta (J.S.H., G.E.U.); the Division of Endocrinology, Metabolism, and Lipid Research, Washington University School of Medicine, St. Louis (J.B.M.); the Division of Endocrinology, Metabolism, and Molecular Medicine, Northwestern University Feinberg School of Medicine, Chicago (M.E.M., A.W.); the Barbara Davis Center for Diabetes, University of Colorado, Aurora (S.P.); and the Department of Medicine, State University of New York Upstate Medical University, Syracuse (R.S.W.).'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Rossing', 'Affiliation': 'From the Research Division, Joslin Diabetes Center, and the Department of Medicine, Harvard Medical School, Boston (A.D., A.B.G., S.E.R.); the Division of Geriatrics, Institute of Gerontology (A.T.G., C.W.), the Department of Biostatistics, School of Public Health (A.T.G., C.S.), Statistical Analysis of Biomedical and Educational Research (SABER) (C.S.), and the Department of Internal Medicine, Metabolism, Endocrinology, and Diabetes (R.P.-B.), University of Michigan, Ann Arbor; the Departments of Medicine, Physiology, and Pharmacology and Toxicology (D.Z.C.) and the Division of Endocrinology and Metabolism (B.A.P.), University of Toronto, the Division of Nephrology, University Health Network (D.Z.C.), LMC Diabetes and Endocrinology (R.A.), and Lunenfeld-Tanenbaum Research Institute, Sinai Health System (B.A.P.), Toronto, the Departments of Medicine, Cardiac Sciences, and Community Health Sciences, Faculties of Medicine and Kinesiology, University of Calgary, Calgary, AB (R.J.S.), BCDiabetes, Vancouver (T.G.E.), and the Division of Endocrinology, University of Alberta, Edmonton (P.S.) - all in Canada; the Departments of Medicine and Population and Data Sciences, University of Texas Southwestern Medical Center, Dallas (I.L.); the Division of Kidney, Urologic, and Hematologic Diseases, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD (A.P.); Steno Diabetes Center, and the Department of Clinical Medicine, University Copenhagen, Copenhagen (P.R.); the Division of Nephrology, Department of Medicine, University of California, Davis (M.A.), and the Department of Pediatrics and Stanford Diabetes Research Center, Stanford University, Palo Alto (D.M.M.) - both in California; the Departments of Medicine and Pediatrics (M.L.C., W.N.R.. M.M.) and Laboratory Medicine and Pathology (A.B.K.), University of Minnesota, Minneapolis; the Division of Endocrinology and Fleischer Institute for Diabetes and Metabolism, Albert Einstein College of Medicine (J.P.C.), and JDRF (Juvenile Diabetes Research Foundation) (M.P.), New York; the Department of Medicine (I.H.B., I.B.H.) and the Nephrology Division (K.R.T.), University of Washington, and the Institute of Translational Health Sciences, Kidney Research Institute (K.R.T.), Seattle, and Providence Health Care, Spokane (K.R.T.) - both in Washington; the Department of Medicine, Emory University, Atlanta (J.S.H., G.E.U.); the Division of Endocrinology, Metabolism, and Lipid Research, Washington University School of Medicine, St. Louis (J.B.M.); the Division of Endocrinology, Metabolism, and Molecular Medicine, Northwestern University Feinberg School of Medicine, Chicago (M.E.M., A.W.); the Barbara Davis Center for Diabetes, University of Colorado, Aurora (S.P.); and the Department of Medicine, State University of New York Upstate Medical University, Syracuse (R.S.W.).'}, {'ForeName': 'Ronald J', 'Initials': 'RJ', 'LastName': 'Sigal', 'Affiliation': 'From the Research Division, Joslin Diabetes Center, and the Department of Medicine, Harvard Medical School, Boston (A.D., A.B.G., S.E.R.); the Division of Geriatrics, Institute of Gerontology (A.T.G., C.W.), the Department of Biostatistics, School of Public Health (A.T.G., C.S.), Statistical Analysis of Biomedical and Educational Research (SABER) (C.S.), and the Department of Internal Medicine, Metabolism, Endocrinology, and Diabetes (R.P.-B.), University of Michigan, Ann Arbor; the Departments of Medicine, Physiology, and Pharmacology and Toxicology (D.Z.C.) and the Division of Endocrinology and Metabolism (B.A.P.), University of Toronto, the Division of Nephrology, University Health Network (D.Z.C.), LMC Diabetes and Endocrinology (R.A.), and Lunenfeld-Tanenbaum Research Institute, Sinai Health System (B.A.P.), Toronto, the Departments of Medicine, Cardiac Sciences, and Community Health Sciences, Faculties of Medicine and Kinesiology, University of Calgary, Calgary, AB (R.J.S.), BCDiabetes, Vancouver (T.G.E.), and the Division of Endocrinology, University of Alberta, Edmonton (P.S.) - all in Canada; the Departments of Medicine and Population and Data Sciences, University of Texas Southwestern Medical Center, Dallas (I.L.); the Division of Kidney, Urologic, and Hematologic Diseases, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD (A.P.); Steno Diabetes Center, and the Department of Clinical Medicine, University Copenhagen, Copenhagen (P.R.); the Division of Nephrology, Department of Medicine, University of California, Davis (M.A.), and the Department of Pediatrics and Stanford Diabetes Research Center, Stanford University, Palo Alto (D.M.M.) - both in California; the Departments of Medicine and Pediatrics (M.L.C., W.N.R.. M.M.) and Laboratory Medicine and Pathology (A.B.K.), University of Minnesota, Minneapolis; the Division of Endocrinology and Fleischer Institute for Diabetes and Metabolism, Albert Einstein College of Medicine (J.P.C.), and JDRF (Juvenile Diabetes Research Foundation) (M.P.), New York; the Department of Medicine (I.H.B., I.B.H.) and the Nephrology Division (K.R.T.), University of Washington, and the Institute of Translational Health Sciences, Kidney Research Institute (K.R.T.), Seattle, and Providence Health Care, Spokane (K.R.T.) - both in Washington; the Department of Medicine, Emory University, Atlanta (J.S.H., G.E.U.); the Division of Endocrinology, Metabolism, and Lipid Research, Washington University School of Medicine, St. Louis (J.B.M.); the Division of Endocrinology, Metabolism, and Molecular Medicine, Northwestern University Feinberg School of Medicine, Chicago (M.E.M., A.W.); the Barbara Davis Center for Diabetes, University of Colorado, Aurora (S.P.); and the Department of Medicine, State University of New York Upstate Medical University, Syracuse (R.S.W.).'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Afkarian', 'Affiliation': 'From the Research Division, Joslin Diabetes Center, and the Department of Medicine, Harvard Medical School, Boston (A.D., A.B.G., S.E.R.); the Division of Geriatrics, Institute of Gerontology (A.T.G., C.W.), the Department of Biostatistics, School of Public Health (A.T.G., C.S.), Statistical Analysis of Biomedical and Educational Research (SABER) (C.S.), and the Department of Internal Medicine, Metabolism, Endocrinology, and Diabetes (R.P.-B.), University of Michigan, Ann Arbor; the Departments of Medicine, Physiology, and Pharmacology and Toxicology (D.Z.C.) and the Division of Endocrinology and Metabolism (B.A.P.), University of Toronto, the Division of Nephrology, University Health Network (D.Z.C.), LMC Diabetes and Endocrinology (R.A.), and Lunenfeld-Tanenbaum Research Institute, Sinai Health System (B.A.P.), Toronto, the Departments of Medicine, Cardiac Sciences, and Community Health Sciences, Faculties of Medicine and Kinesiology, University of Calgary, Calgary, AB (R.J.S.), BCDiabetes, Vancouver (T.G.E.), and the Division of Endocrinology, University of Alberta, Edmonton (P.S.) - all in Canada; the Departments of Medicine and Population and Data Sciences, University of Texas Southwestern Medical Center, Dallas (I.L.); the Division of Kidney, Urologic, and Hematologic Diseases, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD (A.P.); Steno Diabetes Center, and the Department of Clinical Medicine, University Copenhagen, Copenhagen (P.R.); the Division of Nephrology, Department of Medicine, University of California, Davis (M.A.), and the Department of Pediatrics and Stanford Diabetes Research Center, Stanford University, Palo Alto (D.M.M.) - both in California; the Departments of Medicine and Pediatrics (M.L.C., W.N.R.. M.M.) and Laboratory Medicine and Pathology (A.B.K.), University of Minnesota, Minneapolis; the Division of Endocrinology and Fleischer Institute for Diabetes and Metabolism, Albert Einstein College of Medicine (J.P.C.), and JDRF (Juvenile Diabetes Research Foundation) (M.P.), New York; the Department of Medicine (I.H.B., I.B.H.) and the Nephrology Division (K.R.T.), University of Washington, and the Institute of Translational Health Sciences, Kidney Research Institute (K.R.T.), Seattle, and Providence Health Care, Spokane (K.R.T.) - both in Washington; the Department of Medicine, Emory University, Atlanta (J.S.H., G.E.U.); the Division of Endocrinology, Metabolism, and Lipid Research, Washington University School of Medicine, St. Louis (J.B.M.); the Division of Endocrinology, Metabolism, and Molecular Medicine, Northwestern University Feinberg School of Medicine, Chicago (M.E.M., A.W.); the Barbara Davis Center for Diabetes, University of Colorado, Aurora (S.P.); and the Department of Medicine, State University of New York Upstate Medical University, Syracuse (R.S.W.).'}, {'ForeName': 'Ronnie', 'Initials': 'R', 'LastName': 'Aronson', 'Affiliation': 'From the Research Division, Joslin Diabetes Center, and the Department of Medicine, Harvard Medical School, Boston (A.D., A.B.G., S.E.R.); the Division of Geriatrics, Institute of Gerontology (A.T.G., C.W.), the Department of Biostatistics, School of Public Health (A.T.G., C.S.), Statistical Analysis of Biomedical and Educational Research (SABER) (C.S.), and the Department of Internal Medicine, Metabolism, Endocrinology, and Diabetes (R.P.-B.), University of Michigan, Ann Arbor; the Departments of Medicine, Physiology, and Pharmacology and Toxicology (D.Z.C.) and the Division of Endocrinology and Metabolism (B.A.P.), University of Toronto, the Division of Nephrology, University Health Network (D.Z.C.), LMC Diabetes and Endocrinology (R.A.), and Lunenfeld-Tanenbaum Research Institute, Sinai Health System (B.A.P.), Toronto, the Departments of Medicine, Cardiac Sciences, and Community Health Sciences, Faculties of Medicine and Kinesiology, University of Calgary, Calgary, AB (R.J.S.), BCDiabetes, Vancouver (T.G.E.), and the Division of Endocrinology, University of Alberta, Edmonton (P.S.) - all in Canada; the Departments of Medicine and Population and Data Sciences, University of Texas Southwestern Medical Center, Dallas (I.L.); the Division of Kidney, Urologic, and Hematologic Diseases, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD (A.P.); Steno Diabetes Center, and the Department of Clinical Medicine, University Copenhagen, Copenhagen (P.R.); the Division of Nephrology, Department of Medicine, University of California, Davis (M.A.), and the Department of Pediatrics and Stanford Diabetes Research Center, Stanford University, Palo Alto (D.M.M.) - both in California; the Departments of Medicine and Pediatrics (M.L.C., W.N.R.. M.M.) and Laboratory Medicine and Pathology (A.B.K.), University of Minnesota, Minneapolis; the Division of Endocrinology and Fleischer Institute for Diabetes and Metabolism, Albert Einstein College of Medicine (J.P.C.), and JDRF (Juvenile Diabetes Research Foundation) (M.P.), New York; the Department of Medicine (I.H.B., I.B.H.) and the Nephrology Division (K.R.T.), University of Washington, and the Institute of Translational Health Sciences, Kidney Research Institute (K.R.T.), Seattle, and Providence Health Care, Spokane (K.R.T.) - both in Washington; the Department of Medicine, Emory University, Atlanta (J.S.H., G.E.U.); the Division of Endocrinology, Metabolism, and Lipid Research, Washington University School of Medicine, St. Louis (J.B.M.); the Division of Endocrinology, Metabolism, and Molecular Medicine, Northwestern University Feinberg School of Medicine, Chicago (M.E.M., A.W.); the Barbara Davis Center for Diabetes, University of Colorado, Aurora (S.P.); and the Department of Medicine, State University of New York Upstate Medical University, Syracuse (R.S.W.).'}, {'ForeName': 'M Luiza', 'Initials': 'ML', 'LastName': 'Caramori', 'Affiliation': 'From the Research Division, Joslin Diabetes Center, and the Department of Medicine, Harvard Medical School, Boston (A.D., A.B.G., S.E.R.); the Division of Geriatrics, Institute of Gerontology (A.T.G., C.W.), the Department of Biostatistics, School of Public Health (A.T.G., C.S.), Statistical Analysis of Biomedical and Educational Research (SABER) (C.S.), and the Department of Internal Medicine, Metabolism, Endocrinology, and Diabetes (R.P.-B.), University of Michigan, Ann Arbor; the Departments of Medicine, Physiology, and Pharmacology and Toxicology (D.Z.C.) and the Division of Endocrinology and Metabolism (B.A.P.), University of Toronto, the Division of Nephrology, University Health Network (D.Z.C.), LMC Diabetes and Endocrinology (R.A.), and Lunenfeld-Tanenbaum Research Institute, Sinai Health System (B.A.P.), Toronto, the Departments of Medicine, Cardiac Sciences, and Community Health Sciences, Faculties of Medicine and Kinesiology, University of Calgary, Calgary, AB (R.J.S.), BCDiabetes, Vancouver (T.G.E.), and the Division of Endocrinology, University of Alberta, Edmonton (P.S.) - all in Canada; the Departments of Medicine and Population and Data Sciences, University of Texas Southwestern Medical Center, Dallas (I.L.); the Division of Kidney, Urologic, and Hematologic Diseases, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD (A.P.); Steno Diabetes Center, and the Department of Clinical Medicine, University Copenhagen, Copenhagen (P.R.); the Division of Nephrology, Department of Medicine, University of California, Davis (M.A.), and the Department of Pediatrics and Stanford Diabetes Research Center, Stanford University, Palo Alto (D.M.M.) - both in California; the Departments of Medicine and Pediatrics (M.L.C., W.N.R.. M.M.) and Laboratory Medicine and Pathology (A.B.K.), University of Minnesota, Minneapolis; the Division of Endocrinology and Fleischer Institute for Diabetes and Metabolism, Albert Einstein College of Medicine (J.P.C.), and JDRF (Juvenile Diabetes Research Foundation) (M.P.), New York; the Department of Medicine (I.H.B., I.B.H.) and the Nephrology Division (K.R.T.), University of Washington, and the Institute of Translational Health Sciences, Kidney Research Institute (K.R.T.), Seattle, and Providence Health Care, Spokane (K.R.T.) - both in Washington; the Department of Medicine, Emory University, Atlanta (J.S.H., G.E.U.); the Division of Endocrinology, Metabolism, and Lipid Research, Washington University School of Medicine, St. Louis (J.B.M.); the Division of Endocrinology, Metabolism, and Molecular Medicine, Northwestern University Feinberg School of Medicine, Chicago (M.E.M., A.W.); the Barbara Davis Center for Diabetes, University of Colorado, Aurora (S.P.); and the Department of Medicine, State University of New York Upstate Medical University, Syracuse (R.S.W.).'}, {'ForeName': 'Jill P', 'Initials': 'JP', 'LastName': 'Crandall', 'Affiliation': 'From the Research Division, Joslin Diabetes Center, and the Department of Medicine, Harvard Medical School, Boston (A.D., A.B.G., S.E.R.); the Division of Geriatrics, Institute of Gerontology (A.T.G., C.W.), the Department of Biostatistics, School of Public Health (A.T.G., C.S.), Statistical Analysis of Biomedical and Educational Research (SABER) (C.S.), and the Department of Internal Medicine, Metabolism, Endocrinology, and Diabetes (R.P.-B.), University of Michigan, Ann Arbor; the Departments of Medicine, Physiology, and Pharmacology and Toxicology (D.Z.C.) and the Division of Endocrinology and Metabolism (B.A.P.), University of Toronto, the Division of Nephrology, University Health Network (D.Z.C.), LMC Diabetes and Endocrinology (R.A.), and Lunenfeld-Tanenbaum Research Institute, Sinai Health System (B.A.P.), Toronto, the Departments of Medicine, Cardiac Sciences, and Community Health Sciences, Faculties of Medicine and Kinesiology, University of Calgary, Calgary, AB (R.J.S.), BCDiabetes, Vancouver (T.G.E.), and the Division of Endocrinology, University of Alberta, Edmonton (P.S.) - all in Canada; the Departments of Medicine and Population and Data Sciences, University of Texas Southwestern Medical Center, Dallas (I.L.); the Division of Kidney, Urologic, and Hematologic Diseases, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD (A.P.); Steno Diabetes Center, and the Department of Clinical Medicine, University Copenhagen, Copenhagen (P.R.); the Division of Nephrology, Department of Medicine, University of California, Davis (M.A.), and the Department of Pediatrics and Stanford Diabetes Research Center, Stanford University, Palo Alto (D.M.M.) - both in California; the Departments of Medicine and Pediatrics (M.L.C., W.N.R.. M.M.) and Laboratory Medicine and Pathology (A.B.K.), University of Minnesota, Minneapolis; the Division of Endocrinology and Fleischer Institute for Diabetes and Metabolism, Albert Einstein College of Medicine (J.P.C.), and JDRF (Juvenile Diabetes Research Foundation) (M.P.), New York; the Department of Medicine (I.H.B., I.B.H.) and the Nephrology Division (K.R.T.), University of Washington, and the Institute of Translational Health Sciences, Kidney Research Institute (K.R.T.), Seattle, and Providence Health Care, Spokane (K.R.T.) - both in Washington; the Department of Medicine, Emory University, Atlanta (J.S.H., G.E.U.); the Division of Endocrinology, Metabolism, and Lipid Research, Washington University School of Medicine, St. Louis (J.B.M.); the Division of Endocrinology, Metabolism, and Molecular Medicine, Northwestern University Feinberg School of Medicine, Chicago (M.E.M., A.W.); the Barbara Davis Center for Diabetes, University of Colorado, Aurora (S.P.); and the Department of Medicine, State University of New York Upstate Medical University, Syracuse (R.S.W.).'}, {'ForeName': 'Ian H', 'Initials': 'IH', 'LastName': 'de Boer', 'Affiliation': 'From the Research Division, Joslin Diabetes Center, and the Department of Medicine, Harvard Medical School, Boston (A.D., A.B.G., S.E.R.); the Division of Geriatrics, Institute of Gerontology (A.T.G., C.W.), the Department of Biostatistics, School of Public Health (A.T.G., C.S.), Statistical Analysis of Biomedical and Educational Research (SABER) (C.S.), and the Department of Internal Medicine, Metabolism, Endocrinology, and Diabetes (R.P.-B.), University of Michigan, Ann Arbor; the Departments of Medicine, Physiology, and Pharmacology and Toxicology (D.Z.C.) and the Division of Endocrinology and Metabolism (B.A.P.), University of Toronto, the Division of Nephrology, University Health Network (D.Z.C.), LMC Diabetes and Endocrinology (R.A.), and Lunenfeld-Tanenbaum Research Institute, Sinai Health System (B.A.P.), Toronto, the Departments of Medicine, Cardiac Sciences, and Community Health Sciences, Faculties of Medicine and Kinesiology, University of Calgary, Calgary, AB (R.J.S.), BCDiabetes, Vancouver (T.G.E.), and the Division of Endocrinology, University of Alberta, Edmonton (P.S.) - all in Canada; the Departments of Medicine and Population and Data Sciences, University of Texas Southwestern Medical Center, Dallas (I.L.); the Division of Kidney, Urologic, and Hematologic Diseases, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD (A.P.); Steno Diabetes Center, and the Department of Clinical Medicine, University Copenhagen, Copenhagen (P.R.); the Division of Nephrology, Department of Medicine, University of California, Davis (M.A.), and the Department of Pediatrics and Stanford Diabetes Research Center, Stanford University, Palo Alto (D.M.M.) - both in California; the Departments of Medicine and Pediatrics (M.L.C., W.N.R.. M.M.) and Laboratory Medicine and Pathology (A.B.K.), University of Minnesota, Minneapolis; the Division of Endocrinology and Fleischer Institute for Diabetes and Metabolism, Albert Einstein College of Medicine (J.P.C.), and JDRF (Juvenile Diabetes Research Foundation) (M.P.), New York; the Department of Medicine (I.H.B., I.B.H.) and the Nephrology Division (K.R.T.), University of Washington, and the Institute of Translational Health Sciences, Kidney Research Institute (K.R.T.), Seattle, and Providence Health Care, Spokane (K.R.T.) - both in Washington; the Department of Medicine, Emory University, Atlanta (J.S.H., G.E.U.); the Division of Endocrinology, Metabolism, and Lipid Research, Washington University School of Medicine, St. Louis (J.B.M.); the Division of Endocrinology, Metabolism, and Molecular Medicine, Northwestern University Feinberg School of Medicine, Chicago (M.E.M., A.W.); the Barbara Davis Center for Diabetes, University of Colorado, Aurora (S.P.); and the Department of Medicine, State University of New York Upstate Medical University, Syracuse (R.S.W.).'}, {'ForeName': 'Thomas G', 'Initials': 'TG', 'LastName': 'Elliott', 'Affiliation': 'From the Research Division, Joslin Diabetes Center, and the Department of Medicine, Harvard Medical School, Boston (A.D., A.B.G., S.E.R.); the Division of Geriatrics, Institute of Gerontology (A.T.G., C.W.), the Department of Biostatistics, School of Public Health (A.T.G., C.S.), Statistical Analysis of Biomedical and Educational Research (SABER) (C.S.), and the Department of Internal Medicine, Metabolism, Endocrinology, and Diabetes (R.P.-B.), University of Michigan, Ann Arbor; the Departments of Medicine, Physiology, and Pharmacology and Toxicology (D.Z.C.) and the Division of Endocrinology and Metabolism (B.A.P.), University of Toronto, the Division of Nephrology, University Health Network (D.Z.C.), LMC Diabetes and Endocrinology (R.A.), and Lunenfeld-Tanenbaum Research Institute, Sinai Health System (B.A.P.), Toronto, the Departments of Medicine, Cardiac Sciences, and Community Health Sciences, Faculties of Medicine and Kinesiology, University of Calgary, Calgary, AB (R.J.S.), BCDiabetes, Vancouver (T.G.E.), and the Division of Endocrinology, University of Alberta, Edmonton (P.S.) - all in Canada; the Departments of Medicine and Population and Data Sciences, University of Texas Southwestern Medical Center, Dallas (I.L.); the Division of Kidney, Urologic, and Hematologic Diseases, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD (A.P.); Steno Diabetes Center, and the Department of Clinical Medicine, University Copenhagen, Copenhagen (P.R.); the Division of Nephrology, Department of Medicine, University of California, Davis (M.A.), and the Department of Pediatrics and Stanford Diabetes Research Center, Stanford University, Palo Alto (D.M.M.) - both in California; the Departments of Medicine and Pediatrics (M.L.C., W.N.R.. M.M.) and Laboratory Medicine and Pathology (A.B.K.), University of Minnesota, Minneapolis; the Division of Endocrinology and Fleischer Institute for Diabetes and Metabolism, Albert Einstein College of Medicine (J.P.C.), and JDRF (Juvenile Diabetes Research Foundation) (M.P.), New York; the Department of Medicine (I.H.B., I.B.H.) and the Nephrology Division (K.R.T.), University of Washington, and the Institute of Translational Health Sciences, Kidney Research Institute (K.R.T.), Seattle, and Providence Health Care, Spokane (K.R.T.) - both in Washington; the Department of Medicine, Emory University, Atlanta (J.S.H., G.E.U.); the Division of Endocrinology, Metabolism, and Lipid Research, Washington University School of Medicine, St. Louis (J.B.M.); the Division of Endocrinology, Metabolism, and Molecular Medicine, Northwestern University Feinberg School of Medicine, Chicago (M.E.M., A.W.); the Barbara Davis Center for Diabetes, University of Colorado, Aurora (S.P.); and the Department of Medicine, State University of New York Upstate Medical University, Syracuse (R.S.W.).'}, {'ForeName': 'Allison B', 'Initials': 'AB', 'LastName': 'Goldfine', 'Affiliation': 'From the Research Division, Joslin Diabetes Center, and the Department of Medicine, Harvard Medical School, Boston (A.D., A.B.G., S.E.R.); the Division of Geriatrics, Institute of Gerontology (A.T.G., C.W.), the Department of Biostatistics, School of Public Health (A.T.G., C.S.), Statistical Analysis of Biomedical and Educational Research (SABER) (C.S.), and the Department of Internal Medicine, Metabolism, Endocrinology, and Diabetes (R.P.-B.), University of Michigan, Ann Arbor; the Departments of Medicine, Physiology, and Pharmacology and Toxicology (D.Z.C.) and the Division of Endocrinology and Metabolism (B.A.P.), University of Toronto, the Division of Nephrology, University Health Network (D.Z.C.), LMC Diabetes and Endocrinology (R.A.), and Lunenfeld-Tanenbaum Research Institute, Sinai Health System (B.A.P.), Toronto, the Departments of Medicine, Cardiac Sciences, and Community Health Sciences, Faculties of Medicine and Kinesiology, University of Calgary, Calgary, AB (R.J.S.), BCDiabetes, Vancouver (T.G.E.), and the Division of Endocrinology, University of Alberta, Edmonton (P.S.) - all in Canada; the Departments of Medicine and Population and Data Sciences, University of Texas Southwestern Medical Center, Dallas (I.L.); the Division of Kidney, Urologic, and Hematologic Diseases, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD (A.P.); Steno Diabetes Center, and the Department of Clinical Medicine, University Copenhagen, Copenhagen (P.R.); the Division of Nephrology, Department of Medicine, University of California, Davis (M.A.), and the Department of Pediatrics and Stanford Diabetes Research Center, Stanford University, Palo Alto (D.M.M.) - both in California; the Departments of Medicine and Pediatrics (M.L.C., W.N.R.. M.M.) and Laboratory Medicine and Pathology (A.B.K.), University of Minnesota, Minneapolis; the Division of Endocrinology and Fleischer Institute for Diabetes and Metabolism, Albert Einstein College of Medicine (J.P.C.), and JDRF (Juvenile Diabetes Research Foundation) (M.P.), New York; the Department of Medicine (I.H.B., I.B.H.) and the Nephrology Division (K.R.T.), University of Washington, and the Institute of Translational Health Sciences, Kidney Research Institute (K.R.T.), Seattle, and Providence Health Care, Spokane (K.R.T.) - both in Washington; the Department of Medicine, Emory University, Atlanta (J.S.H., G.E.U.); the Division of Endocrinology, Metabolism, and Lipid Research, Washington University School of Medicine, St. Louis (J.B.M.); the Division of Endocrinology, Metabolism, and Molecular Medicine, Northwestern University Feinberg School of Medicine, Chicago (M.E.M., A.W.); the Barbara Davis Center for Diabetes, University of Colorado, Aurora (S.P.); and the Department of Medicine, State University of New York Upstate Medical University, Syracuse (R.S.W.).'}, {'ForeName': 'J Sonya', 'Initials': 'JS', 'LastName': 'Haw', 'Affiliation': 'From the Research Division, Joslin Diabetes Center, and the Department of Medicine, Harvard Medical School, Boston (A.D., A.B.G., S.E.R.); the Division of Geriatrics, Institute of Gerontology (A.T.G., C.W.), the Department of Biostatistics, School of Public Health (A.T.G., C.S.), Statistical Analysis of Biomedical and Educational Research (SABER) (C.S.), and the Department of Internal Medicine, Metabolism, Endocrinology, and Diabetes (R.P.-B.), University of Michigan, Ann Arbor; the Departments of Medicine, Physiology, and Pharmacology and Toxicology (D.Z.C.) and the Division of Endocrinology and Metabolism (B.A.P.), University of Toronto, the Division of Nephrology, University Health Network (D.Z.C.), LMC Diabetes and Endocrinology (R.A.), and Lunenfeld-Tanenbaum Research Institute, Sinai Health System (B.A.P.), Toronto, the Departments of Medicine, Cardiac Sciences, and Community Health Sciences, Faculties of Medicine and Kinesiology, University of Calgary, Calgary, AB (R.J.S.), BCDiabetes, Vancouver (T.G.E.), and the Division of Endocrinology, University of Alberta, Edmonton (P.S.) - all in Canada; the Departments of Medicine and Population and Data Sciences, University of Texas Southwestern Medical Center, Dallas (I.L.); the Division of Kidney, Urologic, and Hematologic Diseases, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD (A.P.); Steno Diabetes Center, and the Department of Clinical Medicine, University Copenhagen, Copenhagen (P.R.); the Division of Nephrology, Department of Medicine, University of California, Davis (M.A.), and the Department of Pediatrics and Stanford Diabetes Research Center, Stanford University, Palo Alto (D.M.M.) - both in California; the Departments of Medicine and Pediatrics (M.L.C., W.N.R.. M.M.) and Laboratory Medicine and Pathology (A.B.K.), University of Minnesota, Minneapolis; the Division of Endocrinology and Fleischer Institute for Diabetes and Metabolism, Albert Einstein College of Medicine (J.P.C.), and JDRF (Juvenile Diabetes Research Foundation) (M.P.), New York; the Department of Medicine (I.H.B., I.B.H.) and the Nephrology Division (K.R.T.), University of Washington, and the Institute of Translational Health Sciences, Kidney Research Institute (K.R.T.), Seattle, and Providence Health Care, Spokane (K.R.T.) - both in Washington; the Department of Medicine, Emory University, Atlanta (J.S.H., G.E.U.); the Division of Endocrinology, Metabolism, and Lipid Research, Washington University School of Medicine, St. Louis (J.B.M.); the Division of Endocrinology, Metabolism, and Molecular Medicine, Northwestern University Feinberg School of Medicine, Chicago (M.E.M., A.W.); the Barbara Davis Center for Diabetes, University of Colorado, Aurora (S.P.); and the Department of Medicine, State University of New York Upstate Medical University, Syracuse (R.S.W.).'}, {'ForeName': 'Irl B', 'Initials': 'IB', 'LastName': 'Hirsch', 'Affiliation': 'From the Research Division, Joslin Diabetes Center, and the Department of Medicine, Harvard Medical School, Boston (A.D., A.B.G., S.E.R.); the Division of Geriatrics, Institute of Gerontology (A.T.G., C.W.), the Department of Biostatistics, School of Public Health (A.T.G., C.S.), Statistical Analysis of Biomedical and Educational Research (SABER) (C.S.), and the Department of Internal Medicine, Metabolism, Endocrinology, and Diabetes (R.P.-B.), University of Michigan, Ann Arbor; the Departments of Medicine, Physiology, and Pharmacology and Toxicology (D.Z.C.) and the Division of Endocrinology and Metabolism (B.A.P.), University of Toronto, the Division of Nephrology, University Health Network (D.Z.C.), LMC Diabetes and Endocrinology (R.A.), and Lunenfeld-Tanenbaum Research Institute, Sinai Health System (B.A.P.), Toronto, the Departments of Medicine, Cardiac Sciences, and Community Health Sciences, Faculties of Medicine and Kinesiology, University of Calgary, Calgary, AB (R.J.S.), BCDiabetes, Vancouver (T.G.E.), and the Division of Endocrinology, University of Alberta, Edmonton (P.S.) - all in Canada; the Departments of Medicine and Population and Data Sciences, University of Texas Southwestern Medical Center, Dallas (I.L.); the Division of Kidney, Urologic, and Hematologic Diseases, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD (A.P.); Steno Diabetes Center, and the Department of Clinical Medicine, University Copenhagen, Copenhagen (P.R.); the Division of Nephrology, Department of Medicine, University of California, Davis (M.A.), and the Department of Pediatrics and Stanford Diabetes Research Center, Stanford University, Palo Alto (D.M.M.) - both in California; the Departments of Medicine and Pediatrics (M.L.C., W.N.R.. M.M.) and Laboratory Medicine and Pathology (A.B.K.), University of Minnesota, Minneapolis; the Division of Endocrinology and Fleischer Institute for Diabetes and Metabolism, Albert Einstein College of Medicine (J.P.C.), and JDRF (Juvenile Diabetes Research Foundation) (M.P.), New York; the Department of Medicine (I.H.B., I.B.H.) and the Nephrology Division (K.R.T.), University of Washington, and the Institute of Translational Health Sciences, Kidney Research Institute (K.R.T.), Seattle, and Providence Health Care, Spokane (K.R.T.) - both in Washington; the Department of Medicine, Emory University, Atlanta (J.S.H., G.E.U.); the Division of Endocrinology, Metabolism, and Lipid Research, Washington University School of Medicine, St. Louis (J.B.M.); the Division of Endocrinology, Metabolism, and Molecular Medicine, Northwestern University Feinberg School of Medicine, Chicago (M.E.M., A.W.); the Barbara Davis Center for Diabetes, University of Colorado, Aurora (S.P.); and the Department of Medicine, State University of New York Upstate Medical University, Syracuse (R.S.W.).'}, {'ForeName': 'Amy B', 'Initials': 'AB', 'LastName': 'Karger', 'Affiliation': 'From the Research Division, Joslin Diabetes Center, and the Department of Medicine, Harvard Medical School, Boston (A.D., A.B.G., S.E.R.); the Division of Geriatrics, Institute of Gerontology (A.T.G., C.W.), the Department of Biostatistics, School of Public Health (A.T.G., C.S.), Statistical Analysis of Biomedical and Educational Research (SABER) (C.S.), and the Department of Internal Medicine, Metabolism, Endocrinology, and Diabetes (R.P.-B.), University of Michigan, Ann Arbor; the Departments of Medicine, Physiology, and Pharmacology and Toxicology (D.Z.C.) and the Division of Endocrinology and Metabolism (B.A.P.), University of Toronto, the Division of Nephrology, University Health Network (D.Z.C.), LMC Diabetes and Endocrinology (R.A.), and Lunenfeld-Tanenbaum Research Institute, Sinai Health System (B.A.P.), Toronto, the Departments of Medicine, Cardiac Sciences, and Community Health Sciences, Faculties of Medicine and Kinesiology, University of Calgary, Calgary, AB (R.J.S.), BCDiabetes, Vancouver (T.G.E.), and the Division of Endocrinology, University of Alberta, Edmonton (P.S.) - all in Canada; the Departments of Medicine and Population and Data Sciences, University of Texas Southwestern Medical Center, Dallas (I.L.); the Division of Kidney, Urologic, and Hematologic Diseases, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD (A.P.); Steno Diabetes Center, and the Department of Clinical Medicine, University Copenhagen, Copenhagen (P.R.); the Division of Nephrology, Department of Medicine, University of California, Davis (M.A.), and the Department of Pediatrics and Stanford Diabetes Research Center, Stanford University, Palo Alto (D.M.M.) - both in California; the Departments of Medicine and Pediatrics (M.L.C., W.N.R.. M.M.) and Laboratory Medicine and Pathology (A.B.K.), University of Minnesota, Minneapolis; the Division of Endocrinology and Fleischer Institute for Diabetes and Metabolism, Albert Einstein College of Medicine (J.P.C.), and JDRF (Juvenile Diabetes Research Foundation) (M.P.), New York; the Department of Medicine (I.H.B., I.B.H.) and the Nephrology Division (K.R.T.), University of Washington, and the Institute of Translational Health Sciences, Kidney Research Institute (K.R.T.), Seattle, and Providence Health Care, Spokane (K.R.T.) - both in Washington; the Department of Medicine, Emory University, Atlanta (J.S.H., G.E.U.); the Division of Endocrinology, Metabolism, and Lipid Research, Washington University School of Medicine, St. Louis (J.B.M.); the Division of Endocrinology, Metabolism, and Molecular Medicine, Northwestern University Feinberg School of Medicine, Chicago (M.E.M., A.W.); the Barbara Davis Center for Diabetes, University of Colorado, Aurora (S.P.); and the Department of Medicine, State University of New York Upstate Medical University, Syracuse (R.S.W.).'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Maahs', 'Affiliation': 'From the Research Division, Joslin Diabetes Center, and the Department of Medicine, Harvard Medical School, Boston (A.D., A.B.G., S.E.R.); the Division of Geriatrics, Institute of Gerontology (A.T.G., C.W.), the Department of Biostatistics, School of Public Health (A.T.G., C.S.), Statistical Analysis of Biomedical and Educational Research (SABER) (C.S.), and the Department of Internal Medicine, Metabolism, Endocrinology, and Diabetes (R.P.-B.), University of Michigan, Ann Arbor; the Departments of Medicine, Physiology, and Pharmacology and Toxicology (D.Z.C.) and the Division of Endocrinology and Metabolism (B.A.P.), University of Toronto, the Division of Nephrology, University Health Network (D.Z.C.), LMC Diabetes and Endocrinology (R.A.), and Lunenfeld-Tanenbaum Research Institute, Sinai Health System (B.A.P.), Toronto, the Departments of Medicine, Cardiac Sciences, and Community Health Sciences, Faculties of Medicine and Kinesiology, University of Calgary, Calgary, AB (R.J.S.), BCDiabetes, Vancouver (T.G.E.), and the Division of Endocrinology, University of Alberta, Edmonton (P.S.) - all in Canada; the Departments of Medicine and Population and Data Sciences, University of Texas Southwestern Medical Center, Dallas (I.L.); the Division of Kidney, Urologic, and Hematologic Diseases, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD (A.P.); Steno Diabetes Center, and the Department of Clinical Medicine, University Copenhagen, Copenhagen (P.R.); the Division of Nephrology, Department of Medicine, University of California, Davis (M.A.), and the Department of Pediatrics and Stanford Diabetes Research Center, Stanford University, Palo Alto (D.M.M.) - both in California; the Departments of Medicine and Pediatrics (M.L.C., W.N.R.. M.M.) and Laboratory Medicine and Pathology (A.B.K.), University of Minnesota, Minneapolis; the Division of Endocrinology and Fleischer Institute for Diabetes and Metabolism, Albert Einstein College of Medicine (J.P.C.), and JDRF (Juvenile Diabetes Research Foundation) (M.P.), New York; the Department of Medicine (I.H.B., I.B.H.) and the Nephrology Division (K.R.T.), University of Washington, and the Institute of Translational Health Sciences, Kidney Research Institute (K.R.T.), Seattle, and Providence Health Care, Spokane (K.R.T.) - both in Washington; the Department of Medicine, Emory University, Atlanta (J.S.H., G.E.U.); the Division of Endocrinology, Metabolism, and Lipid Research, Washington University School of Medicine, St. Louis (J.B.M.); the Division of Endocrinology, Metabolism, and Molecular Medicine, Northwestern University Feinberg School of Medicine, Chicago (M.E.M., A.W.); the Barbara Davis Center for Diabetes, University of Colorado, Aurora (S.P.); and the Department of Medicine, State University of New York Upstate Medical University, Syracuse (R.S.W.).'}, {'ForeName': 'Janet B', 'Initials': 'JB', 'LastName': 'McGill', 'Affiliation': 'From the Research Division, Joslin Diabetes Center, and the Department of Medicine, Harvard Medical School, Boston (A.D., A.B.G., S.E.R.); the Division of Geriatrics, Institute of Gerontology (A.T.G., C.W.), the Department of Biostatistics, School of Public Health (A.T.G., C.S.), Statistical Analysis of Biomedical and Educational Research (SABER) (C.S.), and the Department of Internal Medicine, Metabolism, Endocrinology, and Diabetes (R.P.-B.), University of Michigan, Ann Arbor; the Departments of Medicine, Physiology, and Pharmacology and Toxicology (D.Z.C.) and the Division of Endocrinology and Metabolism (B.A.P.), University of Toronto, the Division of Nephrology, University Health Network (D.Z.C.), LMC Diabetes and Endocrinology (R.A.), and Lunenfeld-Tanenbaum Research Institute, Sinai Health System (B.A.P.), Toronto, the Departments of Medicine, Cardiac Sciences, and Community Health Sciences, Faculties of Medicine and Kinesiology, University of Calgary, Calgary, AB (R.J.S.), BCDiabetes, Vancouver (T.G.E.), and the Division of Endocrinology, University of Alberta, Edmonton (P.S.) - all in Canada; the Departments of Medicine and Population and Data Sciences, University of Texas Southwestern Medical Center, Dallas (I.L.); the Division of Kidney, Urologic, and Hematologic Diseases, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD (A.P.); Steno Diabetes Center, and the Department of Clinical Medicine, University Copenhagen, Copenhagen (P.R.); the Division of Nephrology, Department of Medicine, University of California, Davis (M.A.), and the Department of Pediatrics and Stanford Diabetes Research Center, Stanford University, Palo Alto (D.M.M.) - both in California; the Departments of Medicine and Pediatrics (M.L.C., W.N.R.. M.M.) and Laboratory Medicine and Pathology (A.B.K.), University of Minnesota, Minneapolis; the Division of Endocrinology and Fleischer Institute for Diabetes and Metabolism, Albert Einstein College of Medicine (J.P.C.), and JDRF (Juvenile Diabetes Research Foundation) (M.P.), New York; the Department of Medicine (I.H.B., I.B.H.) and the Nephrology Division (K.R.T.), University of Washington, and the Institute of Translational Health Sciences, Kidney Research Institute (K.R.T.), Seattle, and Providence Health Care, Spokane (K.R.T.) - both in Washington; the Department of Medicine, Emory University, Atlanta (J.S.H., G.E.U.); the Division of Endocrinology, Metabolism, and Lipid Research, Washington University School of Medicine, St. Louis (J.B.M.); the Division of Endocrinology, Metabolism, and Molecular Medicine, Northwestern University Feinberg School of Medicine, Chicago (M.E.M., A.W.); the Barbara Davis Center for Diabetes, University of Colorado, Aurora (S.P.); and the Department of Medicine, State University of New York Upstate Medical University, Syracuse (R.S.W.).'}, {'ForeName': 'Mark E', 'Initials': 'ME', 'LastName': 'Molitch', 'Affiliation': 'From the Research Division, Joslin Diabetes Center, and the Department of Medicine, Harvard Medical School, Boston (A.D., A.B.G., S.E.R.); the Division of Geriatrics, Institute of Gerontology (A.T.G., C.W.), the Department of Biostatistics, School of Public Health (A.T.G., C.S.), Statistical Analysis of Biomedical and Educational Research (SABER) (C.S.), and the Department of Internal Medicine, Metabolism, Endocrinology, and Diabetes (R.P.-B.), University of Michigan, Ann Arbor; the Departments of Medicine, Physiology, and Pharmacology and Toxicology (D.Z.C.) and the Division of Endocrinology and Metabolism (B.A.P.), University of Toronto, the Division of Nephrology, University Health Network (D.Z.C.), LMC Diabetes and Endocrinology (R.A.), and Lunenfeld-Tanenbaum Research Institute, Sinai Health System (B.A.P.), Toronto, the Departments of Medicine, Cardiac Sciences, and Community Health Sciences, Faculties of Medicine and Kinesiology, University of Calgary, Calgary, AB (R.J.S.), BCDiabetes, Vancouver (T.G.E.), and the Division of Endocrinology, University of Alberta, Edmonton (P.S.) - all in Canada; the Departments of Medicine and Population and Data Sciences, University of Texas Southwestern Medical Center, Dallas (I.L.); the Division of Kidney, Urologic, and Hematologic Diseases, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD (A.P.); Steno Diabetes Center, and the Department of Clinical Medicine, University Copenhagen, Copenhagen (P.R.); the Division of Nephrology, Department of Medicine, University of California, Davis (M.A.), and the Department of Pediatrics and Stanford Diabetes Research Center, Stanford University, Palo Alto (D.M.M.) - both in California; the Departments of Medicine and Pediatrics (M.L.C., W.N.R.. M.M.) and Laboratory Medicine and Pathology (A.B.K.), University of Minnesota, Minneapolis; the Division of Endocrinology and Fleischer Institute for Diabetes and Metabolism, Albert Einstein College of Medicine (J.P.C.), and JDRF (Juvenile Diabetes Research Foundation) (M.P.), New York; the Department of Medicine (I.H.B., I.B.H.) and the Nephrology Division (K.R.T.), University of Washington, and the Institute of Translational Health Sciences, Kidney Research Institute (K.R.T.), Seattle, and Providence Health Care, Spokane (K.R.T.) - both in Washington; the Department of Medicine, Emory University, Atlanta (J.S.H., G.E.U.); the Division of Endocrinology, Metabolism, and Lipid Research, Washington University School of Medicine, St. Louis (J.B.M.); the Division of Endocrinology, Metabolism, and Molecular Medicine, Northwestern University Feinberg School of Medicine, Chicago (M.E.M., A.W.); the Barbara Davis Center for Diabetes, University of Colorado, Aurora (S.P.); and the Department of Medicine, State University of New York Upstate Medical University, Syracuse (R.S.W.).'}, {'ForeName': 'Bruce A', 'Initials': 'BA', 'LastName': 'Perkins', 'Affiliation': 'From the Research Division, Joslin Diabetes Center, and the Department of Medicine, Harvard Medical School, Boston (A.D., A.B.G., S.E.R.); the Division of Geriatrics, Institute of Gerontology (A.T.G., C.W.), the Department of Biostatistics, School of Public Health (A.T.G., C.S.), Statistical Analysis of Biomedical and Educational Research (SABER) (C.S.), and the Department of Internal Medicine, Metabolism, Endocrinology, and Diabetes (R.P.-B.), University of Michigan, Ann Arbor; the Departments of Medicine, Physiology, and Pharmacology and Toxicology (D.Z.C.) and the Division of Endocrinology and Metabolism (B.A.P.), University of Toronto, the Division of Nephrology, University Health Network (D.Z.C.), LMC Diabetes and Endocrinology (R.A.), and Lunenfeld-Tanenbaum Research Institute, Sinai Health System (B.A.P.), Toronto, the Departments of Medicine, Cardiac Sciences, and Community Health Sciences, Faculties of Medicine and Kinesiology, University of Calgary, Calgary, AB (R.J.S.), BCDiabetes, Vancouver (T.G.E.), and the Division of Endocrinology, University of Alberta, Edmonton (P.S.) - all in Canada; the Departments of Medicine and Population and Data Sciences, University of Texas Southwestern Medical Center, Dallas (I.L.); the Division of Kidney, Urologic, and Hematologic Diseases, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD (A.P.); Steno Diabetes Center, and the Department of Clinical Medicine, University Copenhagen, Copenhagen (P.R.); the Division of Nephrology, Department of Medicine, University of California, Davis (M.A.), and the Department of Pediatrics and Stanford Diabetes Research Center, Stanford University, Palo Alto (D.M.M.) - both in California; the Departments of Medicine and Pediatrics (M.L.C., W.N.R.. M.M.) and Laboratory Medicine and Pathology (A.B.K.), University of Minnesota, Minneapolis; the Division of Endocrinology and Fleischer Institute for Diabetes and Metabolism, Albert Einstein College of Medicine (J.P.C.), and JDRF (Juvenile Diabetes Research Foundation) (M.P.), New York; the Department of Medicine (I.H.B., I.B.H.) and the Nephrology Division (K.R.T.), University of Washington, and the Institute of Translational Health Sciences, Kidney Research Institute (K.R.T.), Seattle, and Providence Health Care, Spokane (K.R.T.) - both in Washington; the Department of Medicine, Emory University, Atlanta (J.S.H., G.E.U.); the Division of Endocrinology, Metabolism, and Lipid Research, Washington University School of Medicine, St. Louis (J.B.M.); the Division of Endocrinology, Metabolism, and Molecular Medicine, Northwestern University Feinberg School of Medicine, Chicago (M.E.M., A.W.); the Barbara Davis Center for Diabetes, University of Colorado, Aurora (S.P.); and the Department of Medicine, State University of New York Upstate Medical University, Syracuse (R.S.W.).'}, {'ForeName': 'Sarit', 'Initials': 'S', 'LastName': 'Polsky', 'Affiliation': 'From the Research Division, Joslin Diabetes Center, and the Department of Medicine, Harvard Medical School, Boston (A.D., A.B.G., S.E.R.); the Division of Geriatrics, Institute of Gerontology (A.T.G., C.W.), the Department of Biostatistics, School of Public Health (A.T.G., C.S.), Statistical Analysis of Biomedical and Educational Research (SABER) (C.S.), and the Department of Internal Medicine, Metabolism, Endocrinology, and Diabetes (R.P.-B.), University of Michigan, Ann Arbor; the Departments of Medicine, Physiology, and Pharmacology and Toxicology (D.Z.C.) and the Division of Endocrinology and Metabolism (B.A.P.), University of Toronto, the Division of Nephrology, University Health Network (D.Z.C.), LMC Diabetes and Endocrinology (R.A.), and Lunenfeld-Tanenbaum Research Institute, Sinai Health System (B.A.P.), Toronto, the Departments of Medicine, Cardiac Sciences, and Community Health Sciences, Faculties of Medicine and Kinesiology, University of Calgary, Calgary, AB (R.J.S.), BCDiabetes, Vancouver (T.G.E.), and the Division of Endocrinology, University of Alberta, Edmonton (P.S.) - all in Canada; the Departments of Medicine and Population and Data Sciences, University of Texas Southwestern Medical Center, Dallas (I.L.); the Division of Kidney, Urologic, and Hematologic Diseases, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD (A.P.); Steno Diabetes Center, and the Department of Clinical Medicine, University Copenhagen, Copenhagen (P.R.); the Division of Nephrology, Department of Medicine, University of California, Davis (M.A.), and the Department of Pediatrics and Stanford Diabetes Research Center, Stanford University, Palo Alto (D.M.M.) - both in California; the Departments of Medicine and Pediatrics (M.L.C., W.N.R.. M.M.) and Laboratory Medicine and Pathology (A.B.K.), University of Minnesota, Minneapolis; the Division of Endocrinology and Fleischer Institute for Diabetes and Metabolism, Albert Einstein College of Medicine (J.P.C.), and JDRF (Juvenile Diabetes Research Foundation) (M.P.), New York; the Department of Medicine (I.H.B., I.B.H.) and the Nephrology Division (K.R.T.), University of Washington, and the Institute of Translational Health Sciences, Kidney Research Institute (K.R.T.), Seattle, and Providence Health Care, Spokane (K.R.T.) - both in Washington; the Department of Medicine, Emory University, Atlanta (J.S.H., G.E.U.); the Division of Endocrinology, Metabolism, and Lipid Research, Washington University School of Medicine, St. Louis (J.B.M.); the Division of Endocrinology, Metabolism, and Molecular Medicine, Northwestern University Feinberg School of Medicine, Chicago (M.E.M., A.W.); the Barbara Davis Center for Diabetes, University of Colorado, Aurora (S.P.); and the Department of Medicine, State University of New York Upstate Medical University, Syracuse (R.S.W.).'}, {'ForeName': 'Marlon', 'Initials': 'M', 'LastName': 'Pragnell', 'Affiliation': 'From the Research Division, Joslin Diabetes Center, and the Department of Medicine, Harvard Medical School, Boston (A.D., A.B.G., S.E.R.); the Division of Geriatrics, Institute of Gerontology (A.T.G., C.W.), the Department of Biostatistics, School of Public Health (A.T.G., C.S.), Statistical Analysis of Biomedical and Educational Research (SABER) (C.S.), and the Department of Internal Medicine, Metabolism, Endocrinology, and Diabetes (R.P.-B.), University of Michigan, Ann Arbor; the Departments of Medicine, Physiology, and Pharmacology and Toxicology (D.Z.C.) and the Division of Endocrinology and Metabolism (B.A.P.), University of Toronto, the Division of Nephrology, University Health Network (D.Z.C.), LMC Diabetes and Endocrinology (R.A.), and Lunenfeld-Tanenbaum Research Institute, Sinai Health System (B.A.P.), Toronto, the Departments of Medicine, Cardiac Sciences, and Community Health Sciences, Faculties of Medicine and Kinesiology, University of Calgary, Calgary, AB (R.J.S.), BCDiabetes, Vancouver (T.G.E.), and the Division of Endocrinology, University of Alberta, Edmonton (P.S.) - all in Canada; the Departments of Medicine and Population and Data Sciences, University of Texas Southwestern Medical Center, Dallas (I.L.); the Division of Kidney, Urologic, and Hematologic Diseases, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD (A.P.); Steno Diabetes Center, and the Department of Clinical Medicine, University Copenhagen, Copenhagen (P.R.); the Division of Nephrology, Department of Medicine, University of California, Davis (M.A.), and the Department of Pediatrics and Stanford Diabetes Research Center, Stanford University, Palo Alto (D.M.M.) - both in California; the Departments of Medicine and Pediatrics (M.L.C., W.N.R.. M.M.) and Laboratory Medicine and Pathology (A.B.K.), University of Minnesota, Minneapolis; the Division of Endocrinology and Fleischer Institute for Diabetes and Metabolism, Albert Einstein College of Medicine (J.P.C.), and JDRF (Juvenile Diabetes Research Foundation) (M.P.), New York; the Department of Medicine (I.H.B., I.B.H.) and the Nephrology Division (K.R.T.), University of Washington, and the Institute of Translational Health Sciences, Kidney Research Institute (K.R.T.), Seattle, and Providence Health Care, Spokane (K.R.T.) - both in Washington; the Department of Medicine, Emory University, Atlanta (J.S.H., G.E.U.); the Division of Endocrinology, Metabolism, and Lipid Research, Washington University School of Medicine, St. Louis (J.B.M.); the Division of Endocrinology, Metabolism, and Molecular Medicine, Northwestern University Feinberg School of Medicine, Chicago (M.E.M., A.W.); the Barbara Davis Center for Diabetes, University of Colorado, Aurora (S.P.); and the Department of Medicine, State University of New York Upstate Medical University, Syracuse (R.S.W.).'}, {'ForeName': 'William N', 'Initials': 'WN', 'LastName': 'Robiner', 'Affiliation': 'From the Research Division, Joslin Diabetes Center, and the Department of Medicine, Harvard Medical School, Boston (A.D., A.B.G., S.E.R.); the Division of Geriatrics, Institute of Gerontology (A.T.G., C.W.), the Department of Biostatistics, School of Public Health (A.T.G., C.S.), Statistical Analysis of Biomedical and Educational Research (SABER) (C.S.), and the Department of Internal Medicine, Metabolism, Endocrinology, and Diabetes (R.P.-B.), University of Michigan, Ann Arbor; the Departments of Medicine, Physiology, and Pharmacology and Toxicology (D.Z.C.) and the Division of Endocrinology and Metabolism (B.A.P.), University of Toronto, the Division of Nephrology, University Health Network (D.Z.C.), LMC Diabetes and Endocrinology (R.A.), and Lunenfeld-Tanenbaum Research Institute, Sinai Health System (B.A.P.), Toronto, the Departments of Medicine, Cardiac Sciences, and Community Health Sciences, Faculties of Medicine and Kinesiology, University of Calgary, Calgary, AB (R.J.S.), BCDiabetes, Vancouver (T.G.E.), and the Division of Endocrinology, University of Alberta, Edmonton (P.S.) - all in Canada; the Departments of Medicine and Population and Data Sciences, University of Texas Southwestern Medical Center, Dallas (I.L.); the Division of Kidney, Urologic, and Hematologic Diseases, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD (A.P.); Steno Diabetes Center, and the Department of Clinical Medicine, University Copenhagen, Copenhagen (P.R.); the Division of Nephrology, Department of Medicine, University of California, Davis (M.A.), and the Department of Pediatrics and Stanford Diabetes Research Center, Stanford University, Palo Alto (D.M.M.) - both in California; the Departments of Medicine and Pediatrics (M.L.C., W.N.R.. M.M.) and Laboratory Medicine and Pathology (A.B.K.), University of Minnesota, Minneapolis; the Division of Endocrinology and Fleischer Institute for Diabetes and Metabolism, Albert Einstein College of Medicine (J.P.C.), and JDRF (Juvenile Diabetes Research Foundation) (M.P.), New York; the Department of Medicine (I.H.B., I.B.H.) and the Nephrology Division (K.R.T.), University of Washington, and the Institute of Translational Health Sciences, Kidney Research Institute (K.R.T.), Seattle, and Providence Health Care, Spokane (K.R.T.) - both in Washington; the Department of Medicine, Emory University, Atlanta (J.S.H., G.E.U.); the Division of Endocrinology, Metabolism, and Lipid Research, Washington University School of Medicine, St. Louis (J.B.M.); the Division of Endocrinology, Metabolism, and Molecular Medicine, Northwestern University Feinberg School of Medicine, Chicago (M.E.M., A.W.); the Barbara Davis Center for Diabetes, University of Colorado, Aurora (S.P.); and the Department of Medicine, State University of New York Upstate Medical University, Syracuse (R.S.W.).'}, {'ForeName': 'Sylvia E', 'Initials': 'SE', 'LastName': 'Rosas', 'Affiliation': 'From the Research Division, Joslin Diabetes Center, and the Department of Medicine, Harvard Medical School, Boston (A.D., A.B.G., S.E.R.); the Division of Geriatrics, Institute of Gerontology (A.T.G., C.W.), the Department of Biostatistics, School of Public Health (A.T.G., C.S.), Statistical Analysis of Biomedical and Educational Research (SABER) (C.S.), and the Department of Internal Medicine, Metabolism, Endocrinology, and Diabetes (R.P.-B.), University of Michigan, Ann Arbor; the Departments of Medicine, Physiology, and Pharmacology and Toxicology (D.Z.C.) and the Division of Endocrinology and Metabolism (B.A.P.), University of Toronto, the Division of Nephrology, University Health Network (D.Z.C.), LMC Diabetes and Endocrinology (R.A.), and Lunenfeld-Tanenbaum Research Institute, Sinai Health System (B.A.P.), Toronto, the Departments of Medicine, Cardiac Sciences, and Community Health Sciences, Faculties of Medicine and Kinesiology, University of Calgary, Calgary, AB (R.J.S.), BCDiabetes, Vancouver (T.G.E.), and the Division of Endocrinology, University of Alberta, Edmonton (P.S.) - all in Canada; the Departments of Medicine and Population and Data Sciences, University of Texas Southwestern Medical Center, Dallas (I.L.); the Division of Kidney, Urologic, and Hematologic Diseases, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD (A.P.); Steno Diabetes Center, and the Department of Clinical Medicine, University Copenhagen, Copenhagen (P.R.); the Division of Nephrology, Department of Medicine, University of California, Davis (M.A.), and the Department of Pediatrics and Stanford Diabetes Research Center, Stanford University, Palo Alto (D.M.M.) - both in California; the Departments of Medicine and Pediatrics (M.L.C., W.N.R.. M.M.) and Laboratory Medicine and Pathology (A.B.K.), University of Minnesota, Minneapolis; the Division of Endocrinology and Fleischer Institute for Diabetes and Metabolism, Albert Einstein College of Medicine (J.P.C.), and JDRF (Juvenile Diabetes Research Foundation) (M.P.), New York; the Department of Medicine (I.H.B., I.B.H.) and the Nephrology Division (K.R.T.), University of Washington, and the Institute of Translational Health Sciences, Kidney Research Institute (K.R.T.), Seattle, and Providence Health Care, Spokane (K.R.T.) - both in Washington; the Department of Medicine, Emory University, Atlanta (J.S.H., G.E.U.); the Division of Endocrinology, Metabolism, and Lipid Research, Washington University School of Medicine, St. Louis (J.B.M.); the Division of Endocrinology, Metabolism, and Molecular Medicine, Northwestern University Feinberg School of Medicine, Chicago (M.E.M., A.W.); the Barbara Davis Center for Diabetes, University of Colorado, Aurora (S.P.); and the Department of Medicine, State University of New York Upstate Medical University, Syracuse (R.S.W.).'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Senior', 'Affiliation': 'From the Research Division, Joslin Diabetes Center, and the Department of Medicine, Harvard Medical School, Boston (A.D., A.B.G., S.E.R.); the Division of Geriatrics, Institute of Gerontology (A.T.G., C.W.), the Department of Biostatistics, School of Public Health (A.T.G., C.S.), Statistical Analysis of Biomedical and Educational Research (SABER) (C.S.), and the Department of Internal Medicine, Metabolism, Endocrinology, and Diabetes (R.P.-B.), University of Michigan, Ann Arbor; the Departments of Medicine, Physiology, and Pharmacology and Toxicology (D.Z.C.) and the Division of Endocrinology and Metabolism (B.A.P.), University of Toronto, the Division of Nephrology, University Health Network (D.Z.C.), LMC Diabetes and Endocrinology (R.A.), and Lunenfeld-Tanenbaum Research Institute, Sinai Health System (B.A.P.), Toronto, the Departments of Medicine, Cardiac Sciences, and Community Health Sciences, Faculties of Medicine and Kinesiology, University of Calgary, Calgary, AB (R.J.S.), BCDiabetes, Vancouver (T.G.E.), and the Division of Endocrinology, University of Alberta, Edmonton (P.S.) - all in Canada; the Departments of Medicine and Population and Data Sciences, University of Texas Southwestern Medical Center, Dallas (I.L.); the Division of Kidney, Urologic, and Hematologic Diseases, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD (A.P.); Steno Diabetes Center, and the Department of Clinical Medicine, University Copenhagen, Copenhagen (P.R.); the Division of Nephrology, Department of Medicine, University of California, Davis (M.A.), and the Department of Pediatrics and Stanford Diabetes Research Center, Stanford University, Palo Alto (D.M.M.) - both in California; the Departments of Medicine and Pediatrics (M.L.C., W.N.R.. M.M.) and Laboratory Medicine and Pathology (A.B.K.), University of Minnesota, Minneapolis; the Division of Endocrinology and Fleischer Institute for Diabetes and Metabolism, Albert Einstein College of Medicine (J.P.C.), and JDRF (Juvenile Diabetes Research Foundation) (M.P.), New York; the Department of Medicine (I.H.B., I.B.H.) and the Nephrology Division (K.R.T.), University of Washington, and the Institute of Translational Health Sciences, Kidney Research Institute (K.R.T.), Seattle, and Providence Health Care, Spokane (K.R.T.) - both in Washington; the Department of Medicine, Emory University, Atlanta (J.S.H., G.E.U.); the Division of Endocrinology, Metabolism, and Lipid Research, Washington University School of Medicine, St. Louis (J.B.M.); the Division of Endocrinology, Metabolism, and Molecular Medicine, Northwestern University Feinberg School of Medicine, Chicago (M.E.M., A.W.); the Barbara Davis Center for Diabetes, University of Colorado, Aurora (S.P.); and the Department of Medicine, State University of New York Upstate Medical University, Syracuse (R.S.W.).'}, {'ForeName': 'Katherine R', 'Initials': 'KR', 'LastName': 'Tuttle', 'Affiliation': 'From the Research Division, Joslin Diabetes Center, and the Department of Medicine, Harvard Medical School, Boston (A.D., A.B.G., S.E.R.); the Division of Geriatrics, Institute of Gerontology (A.T.G., C.W.), the Department of Biostatistics, School of Public Health (A.T.G., C.S.), Statistical Analysis of Biomedical and Educational Research (SABER) (C.S.), and the Department of Internal Medicine, Metabolism, Endocrinology, and Diabetes (R.P.-B.), University of Michigan, Ann Arbor; the Departments of Medicine, Physiology, and Pharmacology and Toxicology (D.Z.C.) and the Division of Endocrinology and Metabolism (B.A.P.), University of Toronto, the Division of Nephrology, University Health Network (D.Z.C.), LMC Diabetes and Endocrinology (R.A.), and Lunenfeld-Tanenbaum Research Institute, Sinai Health System (B.A.P.), Toronto, the Departments of Medicine, Cardiac Sciences, and Community Health Sciences, Faculties of Medicine and Kinesiology, University of Calgary, Calgary, AB (R.J.S.), BCDiabetes, Vancouver (T.G.E.), and the Division of Endocrinology, University of Alberta, Edmonton (P.S.) - all in Canada; the Departments of Medicine and Population and Data Sciences, University of Texas Southwestern Medical Center, Dallas (I.L.); the Division of Kidney, Urologic, and Hematologic Diseases, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD (A.P.); Steno Diabetes Center, and the Department of Clinical Medicine, University Copenhagen, Copenhagen (P.R.); the Division of Nephrology, Department of Medicine, University of California, Davis (M.A.), and the Department of Pediatrics and Stanford Diabetes Research Center, Stanford University, Palo Alto (D.M.M.) - both in California; the Departments of Medicine and Pediatrics (M.L.C., W.N.R.. M.M.) and Laboratory Medicine and Pathology (A.B.K.), University of Minnesota, Minneapolis; the Division of Endocrinology and Fleischer Institute for Diabetes and Metabolism, Albert Einstein College of Medicine (J.P.C.), and JDRF (Juvenile Diabetes Research Foundation) (M.P.), New York; the Department of Medicine (I.H.B., I.B.H.) and the Nephrology Division (K.R.T.), University of Washington, and the Institute of Translational Health Sciences, Kidney Research Institute (K.R.T.), Seattle, and Providence Health Care, Spokane (K.R.T.) - both in Washington; the Department of Medicine, Emory University, Atlanta (J.S.H., G.E.U.); the Division of Endocrinology, Metabolism, and Lipid Research, Washington University School of Medicine, St. Louis (J.B.M.); the Division of Endocrinology, Metabolism, and Molecular Medicine, Northwestern University Feinberg School of Medicine, Chicago (M.E.M., A.W.); the Barbara Davis Center for Diabetes, University of Colorado, Aurora (S.P.); and the Department of Medicine, State University of New York Upstate Medical University, Syracuse (R.S.W.).'}, {'ForeName': 'Guillermo E', 'Initials': 'GE', 'LastName': 'Umpierrez', 'Affiliation': 'From the Research Division, Joslin Diabetes Center, and the Department of Medicine, Harvard Medical School, Boston (A.D., A.B.G., S.E.R.); the Division of Geriatrics, Institute of Gerontology (A.T.G., C.W.), the Department of Biostatistics, School of Public Health (A.T.G., C.S.), Statistical Analysis of Biomedical and Educational Research (SABER) (C.S.), and the Department of Internal Medicine, Metabolism, Endocrinology, and Diabetes (R.P.-B.), University of Michigan, Ann Arbor; the Departments of Medicine, Physiology, and Pharmacology and Toxicology (D.Z.C.) and the Division of Endocrinology and Metabolism (B.A.P.), University of Toronto, the Division of Nephrology, University Health Network (D.Z.C.), LMC Diabetes and Endocrinology (R.A.), and Lunenfeld-Tanenbaum Research Institute, Sinai Health System (B.A.P.), Toronto, the Departments of Medicine, Cardiac Sciences, and Community Health Sciences, Faculties of Medicine and Kinesiology, University of Calgary, Calgary, AB (R.J.S.), BCDiabetes, Vancouver (T.G.E.), and the Division of Endocrinology, University of Alberta, Edmonton (P.S.) - all in Canada; the Departments of Medicine and Population and Data Sciences, University of Texas Southwestern Medical Center, Dallas (I.L.); the Division of Kidney, Urologic, and Hematologic Diseases, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD (A.P.); Steno Diabetes Center, and the Department of Clinical Medicine, University Copenhagen, Copenhagen (P.R.); the Division of Nephrology, Department of Medicine, University of California, Davis (M.A.), and the Department of Pediatrics and Stanford Diabetes Research Center, Stanford University, Palo Alto (D.M.M.) - both in California; the Departments of Medicine and Pediatrics (M.L.C., W.N.R.. M.M.) and Laboratory Medicine and Pathology (A.B.K.), University of Minnesota, Minneapolis; the Division of Endocrinology and Fleischer Institute for Diabetes and Metabolism, Albert Einstein College of Medicine (J.P.C.), and JDRF (Juvenile Diabetes Research Foundation) (M.P.), New York; the Department of Medicine (I.H.B., I.B.H.) and the Nephrology Division (K.R.T.), University of Washington, and the Institute of Translational Health Sciences, Kidney Research Institute (K.R.T.), Seattle, and Providence Health Care, Spokane (K.R.T.) - both in Washington; the Department of Medicine, Emory University, Atlanta (J.S.H., G.E.U.); the Division of Endocrinology, Metabolism, and Lipid Research, Washington University School of Medicine, St. Louis (J.B.M.); the Division of Endocrinology, Metabolism, and Molecular Medicine, Northwestern University Feinberg School of Medicine, Chicago (M.E.M., A.W.); the Barbara Davis Center for Diabetes, University of Colorado, Aurora (S.P.); and the Department of Medicine, State University of New York Upstate Medical University, Syracuse (R.S.W.).'}, {'ForeName': 'Amisha', 'Initials': 'A', 'LastName': 'Wallia', 'Affiliation': 'From the Research Division, Joslin Diabetes Center, and the Department of Medicine, Harvard Medical School, Boston (A.D., A.B.G., S.E.R.); the Division of Geriatrics, Institute of Gerontology (A.T.G., C.W.), the Department of Biostatistics, School of Public Health (A.T.G., C.S.), Statistical Analysis of Biomedical and Educational Research (SABER) (C.S.), and the Department of Internal Medicine, Metabolism, Endocrinology, and Diabetes (R.P.-B.), University of Michigan, Ann Arbor; the Departments of Medicine, Physiology, and Pharmacology and Toxicology (D.Z.C.) and the Division of Endocrinology and Metabolism (B.A.P.), University of Toronto, the Division of Nephrology, University Health Network (D.Z.C.), LMC Diabetes and Endocrinology (R.A.), and Lunenfeld-Tanenbaum Research Institute, Sinai Health System (B.A.P.), Toronto, the Departments of Medicine, Cardiac Sciences, and Community Health Sciences, Faculties of Medicine and Kinesiology, University of Calgary, Calgary, AB (R.J.S.), BCDiabetes, Vancouver (T.G.E.), and the Division of Endocrinology, University of Alberta, Edmonton (P.S.) - all in Canada; the Departments of Medicine and Population and Data Sciences, University of Texas Southwestern Medical Center, Dallas (I.L.); the Division of Kidney, Urologic, and Hematologic Diseases, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD (A.P.); Steno Diabetes Center, and the Department of Clinical Medicine, University Copenhagen, Copenhagen (P.R.); the Division of Nephrology, Department of Medicine, University of California, Davis (M.A.), and the Department of Pediatrics and Stanford Diabetes Research Center, Stanford University, Palo Alto (D.M.M.) - both in California; the Departments of Medicine and Pediatrics (M.L.C., W.N.R.. M.M.) and Laboratory Medicine and Pathology (A.B.K.), University of Minnesota, Minneapolis; the Division of Endocrinology and Fleischer Institute for Diabetes and Metabolism, Albert Einstein College of Medicine (J.P.C.), and JDRF (Juvenile Diabetes Research Foundation) (M.P.), New York; the Department of Medicine (I.H.B., I.B.H.) and the Nephrology Division (K.R.T.), University of Washington, and the Institute of Translational Health Sciences, Kidney Research Institute (K.R.T.), Seattle, and Providence Health Care, Spokane (K.R.T.) - both in Washington; the Department of Medicine, Emory University, Atlanta (J.S.H., G.E.U.); the Division of Endocrinology, Metabolism, and Lipid Research, Washington University School of Medicine, St. Louis (J.B.M.); the Division of Endocrinology, Metabolism, and Molecular Medicine, Northwestern University Feinberg School of Medicine, Chicago (M.E.M., A.W.); the Barbara Davis Center for Diabetes, University of Colorado, Aurora (S.P.); and the Department of Medicine, State University of New York Upstate Medical University, Syracuse (R.S.W.).'}, {'ForeName': 'Ruth S', 'Initials': 'RS', 'LastName': 'Weinstock', 'Affiliation': 'From the Research Division, Joslin Diabetes Center, and the Department of Medicine, Harvard Medical School, Boston (A.D., A.B.G., S.E.R.); the Division of Geriatrics, Institute of Gerontology (A.T.G., C.W.), the Department of Biostatistics, School of Public Health (A.T.G., C.S.), Statistical Analysis of Biomedical and Educational Research (SABER) (C.S.), and the Department of Internal Medicine, Metabolism, Endocrinology, and Diabetes (R.P.-B.), University of Michigan, Ann Arbor; the Departments of Medicine, Physiology, and Pharmacology and Toxicology (D.Z.C.) and the Division of Endocrinology and Metabolism (B.A.P.), University of Toronto, the Division of Nephrology, University Health Network (D.Z.C.), LMC Diabetes and Endocrinology (R.A.), and Lunenfeld-Tanenbaum Research Institute, Sinai Health System (B.A.P.), Toronto, the Departments of Medicine, Cardiac Sciences, and Community Health Sciences, Faculties of Medicine and Kinesiology, University of Calgary, Calgary, AB (R.J.S.), BCDiabetes, Vancouver (T.G.E.), and the Division of Endocrinology, University of Alberta, Edmonton (P.S.) - all in Canada; the Departments of Medicine and Population and Data Sciences, University of Texas Southwestern Medical Center, Dallas (I.L.); the Division of Kidney, Urologic, and Hematologic Diseases, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD (A.P.); Steno Diabetes Center, and the Department of Clinical Medicine, University Copenhagen, Copenhagen (P.R.); the Division of Nephrology, Department of Medicine, University of California, Davis (M.A.), and the Department of Pediatrics and Stanford Diabetes Research Center, Stanford University, Palo Alto (D.M.M.) - both in California; the Departments of Medicine and Pediatrics (M.L.C., W.N.R.. M.M.) and Laboratory Medicine and Pathology (A.B.K.), University of Minnesota, Minneapolis; the Division of Endocrinology and Fleischer Institute for Diabetes and Metabolism, Albert Einstein College of Medicine (J.P.C.), and JDRF (Juvenile Diabetes Research Foundation) (M.P.), New York; the Department of Medicine (I.H.B., I.B.H.) and the Nephrology Division (K.R.T.), University of Washington, and the Institute of Translational Health Sciences, Kidney Research Institute (K.R.T.), Seattle, and Providence Health Care, Spokane (K.R.T.) - both in Washington; the Department of Medicine, Emory University, Atlanta (J.S.H., G.E.U.); the Division of Endocrinology, Metabolism, and Lipid Research, Washington University School of Medicine, St. Louis (J.B.M.); the Division of Endocrinology, Metabolism, and Molecular Medicine, Northwestern University Feinberg School of Medicine, Chicago (M.E.M., A.W.); the Barbara Davis Center for Diabetes, University of Colorado, Aurora (S.P.); and the Department of Medicine, State University of New York Upstate Medical University, Syracuse (R.S.W.).'}, {'ForeName': 'Chunyi', 'Initials': 'C', 'LastName': 'Wu', 'Affiliation': 'From the Research Division, Joslin Diabetes Center, and the Department of Medicine, Harvard Medical School, Boston (A.D., A.B.G., S.E.R.); the Division of Geriatrics, Institute of Gerontology (A.T.G., C.W.), the Department of Biostatistics, School of Public Health (A.T.G., C.S.), Statistical Analysis of Biomedical and Educational Research (SABER) (C.S.), and the Department of Internal Medicine, Metabolism, Endocrinology, and Diabetes (R.P.-B.), University of Michigan, Ann Arbor; the Departments of Medicine, Physiology, and Pharmacology and Toxicology (D.Z.C.) and the Division of Endocrinology and Metabolism (B.A.P.), University of Toronto, the Division of Nephrology, University Health Network (D.Z.C.), LMC Diabetes and Endocrinology (R.A.), and Lunenfeld-Tanenbaum Research Institute, Sinai Health System (B.A.P.), Toronto, the Departments of Medicine, Cardiac Sciences, and Community Health Sciences, Faculties of Medicine and Kinesiology, University of Calgary, Calgary, AB (R.J.S.), BCDiabetes, Vancouver (T.G.E.), and the Division of Endocrinology, University of Alberta, Edmonton (P.S.) - all in Canada; the Departments of Medicine and Population and Data Sciences, University of Texas Southwestern Medical Center, Dallas (I.L.); the Division of Kidney, Urologic, and Hematologic Diseases, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD (A.P.); Steno Diabetes Center, and the Department of Clinical Medicine, University Copenhagen, Copenhagen (P.R.); the Division of Nephrology, Department of Medicine, University of California, Davis (M.A.), and the Department of Pediatrics and Stanford Diabetes Research Center, Stanford University, Palo Alto (D.M.M.) - both in California; the Departments of Medicine and Pediatrics (M.L.C., W.N.R.. M.M.) and Laboratory Medicine and Pathology (A.B.K.), University of Minnesota, Minneapolis; the Division of Endocrinology and Fleischer Institute for Diabetes and Metabolism, Albert Einstein College of Medicine (J.P.C.), and JDRF (Juvenile Diabetes Research Foundation) (M.P.), New York; the Department of Medicine (I.H.B., I.B.H.) and the Nephrology Division (K.R.T.), University of Washington, and the Institute of Translational Health Sciences, Kidney Research Institute (K.R.T.), Seattle, and Providence Health Care, Spokane (K.R.T.) - both in Washington; the Department of Medicine, Emory University, Atlanta (J.S.H., G.E.U.); the Division of Endocrinology, Metabolism, and Lipid Research, Washington University School of Medicine, St. Louis (J.B.M.); the Division of Endocrinology, Metabolism, and Molecular Medicine, Northwestern University Feinberg School of Medicine, Chicago (M.E.M., A.W.); the Barbara Davis Center for Diabetes, University of Colorado, Aurora (S.P.); and the Department of Medicine, State University of New York Upstate Medical University, Syracuse (R.S.W.).'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Mauer', 'Affiliation': 'From the Research Division, Joslin Diabetes Center, and the Department of Medicine, Harvard Medical School, Boston (A.D., A.B.G., S.E.R.); the Division of Geriatrics, Institute of Gerontology (A.T.G., C.W.), the Department of Biostatistics, School of Public Health (A.T.G., C.S.), Statistical Analysis of Biomedical and Educational Research (SABER) (C.S.), and the Department of Internal Medicine, Metabolism, Endocrinology, and Diabetes (R.P.-B.), University of Michigan, Ann Arbor; the Departments of Medicine, Physiology, and Pharmacology and Toxicology (D.Z.C.) and the Division of Endocrinology and Metabolism (B.A.P.), University of Toronto, the Division of Nephrology, University Health Network (D.Z.C.), LMC Diabetes and Endocrinology (R.A.), and Lunenfeld-Tanenbaum Research Institute, Sinai Health System (B.A.P.), Toronto, the Departments of Medicine, Cardiac Sciences, and Community Health Sciences, Faculties of Medicine and Kinesiology, University of Calgary, Calgary, AB (R.J.S.), BCDiabetes, Vancouver (T.G.E.), and the Division of Endocrinology, University of Alberta, Edmonton (P.S.) - all in Canada; the Departments of Medicine and Population and Data Sciences, University of Texas Southwestern Medical Center, Dallas (I.L.); the Division of Kidney, Urologic, and Hematologic Diseases, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD (A.P.); Steno Diabetes Center, and the Department of Clinical Medicine, University Copenhagen, Copenhagen (P.R.); the Division of Nephrology, Department of Medicine, University of California, Davis (M.A.), and the Department of Pediatrics and Stanford Diabetes Research Center, Stanford University, Palo Alto (D.M.M.) - both in California; the Departments of Medicine and Pediatrics (M.L.C., W.N.R.. M.M.) and Laboratory Medicine and Pathology (A.B.K.), University of Minnesota, Minneapolis; the Division of Endocrinology and Fleischer Institute for Diabetes and Metabolism, Albert Einstein College of Medicine (J.P.C.), and JDRF (Juvenile Diabetes Research Foundation) (M.P.), New York; the Department of Medicine (I.H.B., I.B.H.) and the Nephrology Division (K.R.T.), University of Washington, and the Institute of Translational Health Sciences, Kidney Research Institute (K.R.T.), Seattle, and Providence Health Care, Spokane (K.R.T.) - both in Washington; the Department of Medicine, Emory University, Atlanta (J.S.H., G.E.U.); the Division of Endocrinology, Metabolism, and Lipid Research, Washington University School of Medicine, St. Louis (J.B.M.); the Division of Endocrinology, Metabolism, and Molecular Medicine, Northwestern University Feinberg School of Medicine, Chicago (M.E.M., A.W.); the Barbara Davis Center for Diabetes, University of Colorado, Aurora (S.P.); and the Department of Medicine, State University of New York Upstate Medical University, Syracuse (R.S.W.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The New England journal of medicine,['10.1056/NEJMoa1916624'] 1990,32459987,Client memory and learning of treatment contents: An experimental study of intervention strategies and relationship to outcome in a brief treatment for procrastination.,"BACKGROUND AND OBJECTIVES Client memory and learning is limited for psychological treatment contents. This study investigated different approaches to support client memory and learning of treatment contents and the relationship between memory and learning of treatment contents and outcome. METHODS Adult participants (n = 428) were recruited through Amazon's Mechanical Turk and randomized to complete one of three versions of a one-session procrastination intervention. Two versions of the intervention included different amounts of memory support strategy types from the Memory Support Intervention. A control version did not include any types of memory support. Memory and learning of treatment contents were assessed immediately after the intervention and one week later. Procrastination and two mechanisms of procrastination (impulsiveness and self-efficacy) were assessed at baseline and one week after the intervention. RESULTS Contrary to the hypotheses, a version of the intervention with multiple types of memory support strategies was not associated with better memory and learning of treatment contents than a version of the intervention with only one type of memory support strategy or the control intervention. Greater memory and learning of treatment contents predicted improvement in mechanisms of procrastination, but not procrastination itself. LIMITATIONS The mean level of procrastination in this study was lower than in other treatment studies of procrastination. CONCLUSIONS Results partially support the rationale for the Memory Support Intervention that improving client memory and learning of treatment contents can improve outcome. Findings suggest that the Memory Support Intervention may be simplified to include fewer strategies without compromising efficacy.",2020,"Contrary to the hypotheses, a version of the intervention with multiple types of memory support strategies was not associated with better memory and learning of treatment contents than a version of the intervention with only one type of memory support strategy or the control intervention.",['Adult participants (n\xa0=\xa0428'],"[""Amazon's Mechanical Turk""]","['Memory and learning of treatment contents', 'procrastination (impulsiveness and self-efficacy', 'mean level of procrastination', 'Client memory and learning of treatment contents']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4517775', 'cui_str': '428'}]","[{'cui': 'C0325969', 'cui_str': 'Genus Amazona'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0337911', 'cui_str': 'Turks'}]","[{'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0871142', 'cui_str': 'Procrastination'}, {'cui': 'C0564567', 'cui_str': 'Impulsive character'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0008942', 'cui_str': 'Clients'}]",428.0,0.032357,"Contrary to the hypotheses, a version of the intervention with multiple types of memory support strategies was not associated with better memory and learning of treatment contents than a version of the intervention with only one type of memory support strategy or the control intervention.","[{'ForeName': 'Garret G', 'Initials': 'GG', 'LastName': 'Zieve', 'Affiliation': 'University of California, Berkeley, United States.'}, {'ForeName': 'Cara', 'Initials': 'C', 'LastName': 'Woodworth', 'Affiliation': 'University of California, Berkeley, United States.'}, {'ForeName': 'Allison G', 'Initials': 'AG', 'LastName': 'Harvey', 'Affiliation': 'University of California, Berkeley, United States. Electronic address: aharvey@berkeley.edu.'}]",Journal of behavior therapy and experimental psychiatry,['10.1016/j.jbtep.2020.101579'] 1991,32460145,Effect of cognitive rehabilitation on neuropsychological and semiecological testing and on daily cognitive functioning in multiple sclerosis: The REACTIV randomized controlled study.,"BACKGROUND Specific cognitive rehabilitation (SCR) has been suggested for multiple sclerosis (MS). A randomized controlled trial (RCT) evaluating the therapeutic effects of SCR is necessary. OBJECTIVE To demonstrate the superiority of a SCR program (REACTIV) over nonspecific intervention (NSI) for neuropsychological (NP) assessment, virtual reality (VR) cognitive testing and daily cognitive functioning. METHODS A single-blind RCT compared SCR and NSI in patients with MS with cognitive complaint. Both programs included 50 individual sessions, 3 times a week for 17 weeks in a real-world setting. The primary end-point was NP assessment. Secondary end-points included semiecological VR tasks (Urban Daily Cog®) and daily cognitive functioning assessment. Maintenance of the effects at 8 months was studied. RESULTS Of the 35 patients, 18 completed the SCR, and 17 completed the NSI. Several NP and semiecological scores improved significantly more after SCR than after NSI. More NP scores improved significantly after SCR than after NSI. SCR improved daily cognitive functioning. Most improvements were maintained at 8 months. CONCLUSION SCR performed in a real-world setting is superior to NSI for improving performance in specific cognitive domains and information processing speed, and for improving cognitive functioning, as evaluated by ecological tools close to daily life and a daily cognitive functioning questionnaire.",2020,"CONCLUSION SCR performed in a real-world setting is superior to NSI for improving performance in specific cognitive domains and information processing speed, and for improving cognitive functioning, as evaluated by ecological tools close to daily life and a daily cognitive functioning questionnaire.","['35 patients', 'patients with MS with cognitive complaint', 'multiple sclerosis']","['Specific cognitive rehabilitation (SCR', 'cognitive rehabilitation', 'SCR program (REACTIV) over nonspecific intervention (NSI) for neuropsychological (NP) assessment, virtual reality (VR) cognitive testing and daily cognitive functioning']","['SCR improved daily cognitive functioning', 'semiecological VR tasks (Urban Daily Cog®) and daily cognitive functioning assessment', 'NP scores', 'Several NP and semiecological scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0277786', 'cui_str': 'Complaint'}]","[{'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0870303', 'cui_str': 'Cognitive rehabilitation'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0027902', 'cui_str': 'Neuropsychological testing'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}]","[{'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0870303', 'cui_str': 'Cognitive rehabilitation'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0009738', 'cui_str': 'Congo'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.067952,"CONCLUSION SCR performed in a real-world setting is superior to NSI for improving performance in specific cognitive domains and information processing speed, and for improving cognitive functioning, as evaluated by ecological tools close to daily life and a daily cognitive functioning questionnaire.","[{'ForeName': 'D', 'Initials': 'D', 'LastName': 'Lamargue', 'Affiliation': 'Univ. Bordeaux, F-33000 Bordeaux, France; Inserm U1215 - Neurocentre Magendie, F-33000 Bordeaux, France.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Koubiyr', 'Affiliation': 'Univ. Bordeaux, F-33000 Bordeaux, France; Inserm U1215 - Neurocentre Magendie, F-33000 Bordeaux, France.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Deloire', 'Affiliation': 'CHU de Bordeaux, F-33000 Bordeaux, France.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Saubusse', 'Affiliation': 'CHU de Bordeaux, F-33000 Bordeaux, France.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Charre-Morin', 'Affiliation': 'CHU de Bordeaux, F-33000 Bordeaux, France.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Moroso', 'Affiliation': 'CHU de Bordeaux, F-33000 Bordeaux, France.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Coupé', 'Affiliation': 'Laboratoire Bordelais de Recherche en Informatique, UMR CNRS 5800, PICTURA, F-33405 Talence, France.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Brochet', 'Affiliation': 'Univ. Bordeaux, F-33000 Bordeaux, France; Inserm U1215 - Neurocentre Magendie, F-33000 Bordeaux, France; CHU de Bordeaux, F-33000 Bordeaux, France. Electronic address: bruno.brochet@chu-bordeaux.fr.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Ruet', 'Affiliation': 'Univ. Bordeaux, F-33000 Bordeaux, France; Inserm U1215 - Neurocentre Magendie, F-33000 Bordeaux, France; CHU de Bordeaux, F-33000 Bordeaux, France.'}]",Journal of the neurological sciences,['10.1016/j.jns.2020.116929'] 1992,32468087,Nangibotide in patients with septic shock: a Phase 2a randomized controlled clinical trial.,"PURPOSE Nangibotide is a specific TREM-1 inhibitor that tempered deleterious host-pathogens interactions, restored vascular function, and improved survival, in animal septic shock models. This study evaluated the safety and pharmacokinetics of nangibotide and its effects on clinical and pharmacodynamic parameters in septic shock patients. METHODS This was a multicenter randomized, double-blind, two-stage study. Patients received either continuous infusion of nangibotide (0.3, 1.0, or 3.0 mg/kg/h) or placebo. Treatment began < 24 h after shock onset and continued for up to 5 days. Safety primary outcomes were adverse events (AEs), whether serious or not, and death. Exploratory endpoints evaluated nangibotide effects on pharmacodynamics, organ function, and mortality, and were analyzed according to baseline sTREM-1 concentrations. RESULTS Forty-nine patients were randomized. All treatment emergent AEs (TEAEs) were collected until Day 28. No significant differences were observed in TEAEs between treatment groups. No drug withdrawal linked to TEAE nor appearance of anti-drug antibodies were reported. Nangibotide pharmacokinetics appeared to be dose-proportional and clearance was dose-independent. Nangibotide did not significantly affect pharmacodynamic markers. Decrease in SOFA score LS mean change (± SE) from baseline to Day 5 in pooled nangibotide groups versus placebo was - 0.7 (± 0.85) in the randomized population and - 1.5 (± 1.12) in patients with high baseline plasma sTREM-1 concentrations (non-significant). This pattern was similar to organ support end points. CONCLUSION No significant increases in TEAEs were detected in nangibotide-treated patients versus placebo. These results encourage further evaluation of nangibotide and further exploration of plasma sTREM-1 concentrations as a predictive efficacy biomarker.",2020,No significant differences were observed in TEAEs between treatment groups.,"['septic shock patients', 'patients with septic shock', 'Forty-nine patients were randomized']","['Nangibotide', 'continuous infusion of nangibotide', 'placebo']","['Nangibotide pharmacokinetics', 'nangibotide effects on pharmacodynamics, organ function, and mortality', 'TEAEs', 'pharmacodynamic markers', 'SOFA score LS mean change (±\u2009SE', 'adverse events (AEs), whether serious or not, and death']","[{'cui': 'C0036983', 'cui_str': 'Septic shock'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0444889', 'cui_str': 'Continuous infusion'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",49.0,0.585864,No significant differences were observed in TEAEs between treatment groups.,"[{'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'François', 'Affiliation': 'Medical-Surgical ICU Department and Inserm CIC1435 & UMR1092, CRICS-TRIGGERSEP Network, CHU Limoges, Limoges, France. b.francois@unilim.fr.'}, {'ForeName': 'Xavier', 'Initials': 'X', 'LastName': 'Wittebole', 'Affiliation': 'Department of Critical Care Medicine, St Luc University Hospital, Université Catholique de Louvain, Brussels, Belgium.'}, {'ForeName': 'Ricard', 'Initials': 'R', 'LastName': 'Ferrer', 'Affiliation': ""ICU Department, Vall d'Hebron University Hospital, Barcelona, Spain.""}, {'ForeName': 'Jean-Paul', 'Initials': 'JP', 'LastName': 'Mira', 'Affiliation': 'Medical ICU, Cochin Hotel-Dieu, AP-HP, Paris, France.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Dugernier', 'Affiliation': 'ICU Department, Clinique St. Pierre, Ottignies, Belgium.'}, {'ForeName': 'Sébastien', 'Initials': 'S', 'LastName': 'Gibot', 'Affiliation': 'Medical ICU Department, Hospital Central, CHU Nancy, Nancy, France.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Derive', 'Affiliation': 'Inotrem SA, Paris, France.'}, {'ForeName': 'Aurélie', 'Initials': 'A', 'LastName': 'Olivier', 'Affiliation': 'Inotrem SA, Paris, France.'}, {'ForeName': 'Valérie', 'Initials': 'V', 'LastName': 'Cuvier', 'Affiliation': 'Inotrem SA, Paris, France.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Witte', 'Affiliation': 'Helion Pharma, Schriesheim, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Pickkers', 'Affiliation': 'ICU Department, Radboudumc Hospital, Nijmegen, The Netherlands.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Vandenhende', 'Affiliation': 'ClinBay SPRL, Baisy-Thy, Belgium.'}, {'ForeName': 'Jean-Jacques', 'Initials': 'JJ', 'LastName': 'Garaud', 'Affiliation': 'Inotrem SA, Paris, France.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Sánchez', 'Affiliation': 'ICU Department, Hospital Clínico San Carlos, Madrid, Spain.'}, {'ForeName': 'Margarita', 'Initials': 'M', 'LastName': 'Salcedo-Magguilli', 'Affiliation': 'Inotrem SA, Paris, France.'}, {'ForeName': 'Pierre-François', 'Initials': 'PF', 'LastName': 'Laterre', 'Affiliation': 'Department of Critical Care Medicine, St Luc University Hospital, Université Catholique de Louvain, Brussels, Belgium.'}]",Intensive care medicine,['10.1007/s00134-020-06109-z'] 1993,32585581,"Zataria multiflora affects clinical symptoms, oxidative stress and cytokines in asthmatic patient: A randomized, double blind, placebo-controlled, phase II clinical trial.","BACKGROUND Z. multiflora effect on clinical symptoms, pulmonary function tests (PFT), oxidative stress and cytokine levels in asthmatic patients were evaluated. METHODS 36 asthmatic patients were divided to; placebo group (P), two groups treated with Z. multiflora extract (5 and 10 mg/kg/day, as Z5 and Z10, respectively), (n = 12 in each group). Medications were administered three times a day for two months and several parameters were evaluated before treatment (step 0), one (step 1) and two months (step 2) after treatment. RESULTS Clinical symptoms and PFTs were significantly improved in Z5 and Z10 groups in steps 1 and 2 compared to step 0 (p < 0.05 to p < 0.001). Improvement of oxidative stress, cytokines levels and their gene expression after treatment with both doses of extract were observed in step 2 compared to step 0 (p < 0.05 to p < 0.001). CONCLUSION These results indicated therapeutic value of Z. multiflora for the management of asthma.",2020,"Improvement of oxidative stress, cytokines levels and their gene expression after treatment with both doses of extract were observed in step 2 compared to step 0 (p < 0.05 to p < 0.001). ","['36 asthmatic patients', 'asthmatic patient', 'asthmatic patients were evaluated']","['Zataria multiflora', 'Z. multiflora extract', 'placebo']","['oxidative stress, cytokines levels and their gene expression', 'Clinical symptoms and PFTs', 'clinical symptoms, pulmonary function tests (PFT), oxidative stress and cytokine levels']","[{'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}]",36.0,0.141139,"Improvement of oxidative stress, cytokines levels and their gene expression after treatment with both doses of extract were observed in step 2 compared to step 0 (p < 0.05 to p < 0.001). ","[{'ForeName': 'Azam', 'Initials': 'A', 'LastName': 'Alavinezhad', 'Affiliation': 'Neurogenic Inflammation Research Center, Mashhad University of Medical Sciences, Mashhad, Iran; Department of Physiology, School of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Vahideh', 'Initials': 'V', 'LastName': 'Ghorani', 'Affiliation': 'Neurogenic Inflammation Research Center, Mashhad University of Medical Sciences, Mashhad, Iran; Department of Physiology, School of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Omid', 'Initials': 'O', 'LastName': 'Rajabi', 'Affiliation': 'Department of Drug and Food Control, School of Pharmacy, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Mohammad Hossein', 'Initials': 'MH', 'LastName': 'Boskabady', 'Affiliation': 'Neurogenic Inflammation Research Center, Mashhad University of Medical Sciences, Mashhad, Iran; Department of Physiology, School of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran. Electronic address: boskabadymh@mums.ac.ir.'}]",Cytokine,['10.1016/j.cyto.2020.155169'] 1994,32585686,Gonadotrophins or clomiphene citrate in women with normogonadotropic anovulation and CC failure: does the endometrium matter?,"STUDY QUESTION Is endometrial thickness (EMT) a biomarker to select between women who should switch to gonadotropins and those who could continue clomiphene citrate (CC) after six failed ovulatory cycles? SUMMARY ANSWER Using a cut-off of 7 mm for EMT, we can distinguish between women who are better off switching to gonadotropins and those who could continue CC after six earlier failed ovulatory CC cycles. WHAT IS ALREADY KNOWN For women with normogonadotropic anovulation, CC has been a long-standing first-line treatment in conjunction with intercourse or intrauterine insemination (IUI). We recently showed that a switch to gonadotropins increases the chance of live birth by 11% in these women over continued treatment with CC after six failed ovulatory cycles, at a cost of €15 258 per additional live birth. It is unclear whether EMT can be used to identify women who can continue on CC with similar live birth rates without the extra costs of gonadotropins. STUDY DESIGN, SIZE, DURATION Between 8 December 2008 and 16 December 2015, 666 women with CC failure were randomly assigned to receive an additional six cycles with a change to gonadotropins (n = 331) or an additional six cycles continuing with CC (n = 335), both in conjunction with intercourse or IUI. The primary outcome was conception leading to live birth within 8 months after randomisation. EMT was measured mid-cycle before randomisation during their sixth ovulatory CC cycle. The EMT was available in 380 women, of whom 190 were allocated to gonadotropins and 190 were allocated to CC. PARTICIPANTS/MATERIALS, SETTING, METHODS EMT was determined in the sixth CC cycle prior to randomisation. We tested for interaction of EMT with the treatment effect using logistic regression. We performed a spline analysis to evaluate the association of EMT with chance to pregnancy leading to a live birth in the next cycles and to determine the best cut-off point. On the basis of the resulting cut-off point, we calculated the relative risk and 95% CI of live birth for gonadotropins versus CC at EMT values below and above this cut-off point. Finally, we calculated incremental cost-effectiveness ratios (ICER). MAIN RESULTS AND THE ROLE OF CHANCE Mid-cycle EMT in the sixth cycle interacted with treatment effect (P < 0.01). Spline analyses showed a cut-off point of 7 mm. There were 162 women (45%) who had an EMT ≤ 7 mm in the sixth ovulatory cycle and 218 women (55%) who had an EMT > 7 mm. Among the women with EMT ≤ 7 mm, gonadotropins resulted in a live birth in 44 of 79 women (56%), while CC resulted in a live birth in 28 of 83 women (34%) (RR 1.57, 95% CI 1.13-2.19). Per additional live birth with gonadotropins, the ICER was €9709 (95% CI: €5117 to €25 302). Among the women with EMT > 7 mm, gonadotropins resulted in a live birth in 53 of 111 women (48%) while CC resulted in a live birth in 52 of 107 women (49%) (RR 0.98, 95% CI 0.75-1.29). LIMITATIONS, REASONS FOR CAUTION This was a post hoc analysis of a randomised controlled trial (RCT) and therefore mid-cycle EMT measurements before randomisation during their sixth ovulatory CC cycle were not available for all included women. WIDER IMPLICATIONS OF THE FINDINGS In women with six failed ovulatory cycles on CC and an EMT ≤ 7 mm in the sixth cycle, we advise switching to gonadotropins, since it improves live birth rate over continuing treatment with CC at an extra cost of €9709 to achieve one additional live birth. If the EMT > 7 mm, we advise to continue treatment with CC, since live birth rates are similar to those with gonadotropins, without the extra costs. STUDY FUNDING/COMPETING INTEREST(S) The original MOVIN trial received funding from the Dutch Organization for Health Research and Development (ZonMw number: 80-82310-97-12067). C.B.L.A. reports unrestricted grant support from Merck and Ferring. B.W.M. is supported by a NHMRC Practitioner Fellowship (GNT1082548) and reports consultancy for Merck, ObsEva, IGENOMIX and Guerbet. All other authors have nothing to declare. TRIAL REGISTRATION NUMBER Netherlands Trial Register, number NTR1449.",2020,"Per additional live birth with gonadotropins, the ICER was €9709 (95% CI: €5117 to €25 302).","['380 women, of whom 190 were allocated to', '162 women (45%) who had an EMT\u2009≤\u20097\xa0mm in the sixth ovulatory cycle and 218 women (55%) who had an EMT\u2009>\u20097\xa0mm', 'women with normogonadotropic anovulation and CC failure', 'women who should switch to gonadotropins and those who could continue', 'Between 8 December 2008 and 16 December 2015, 666 women with CC failure']","['EMT', 'additional six cycles with a change to gonadotropins (n\xa0=\u2009331) or an additional six cycles continuing with CC (n\xa0=\u2009335), both in conjunction with intercourse or IUI', 'gonadotropins', 'clomiphene citrate (CC', 'Gonadotrophins or clomiphene citrate']","['live birth', 'chance of live birth', 'incremental cost-effectiveness ratios (ICER', 'live birth rate', 'conception leading to live birth']","[{'cui': 'C4319693', 'cui_str': '380'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517622', 'cui_str': '190'}, {'cui': 'C5191360', 'cui_str': '162'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0205440', 'cui_str': 'Sixth'}, {'cui': 'C0429470', 'cui_str': 'Ovulatory'}, {'cui': 'C4517647', 'cui_str': '218'}, {'cui': 'C0003128', 'cui_str': 'Anovulation'}, {'cui': 'C0546859', 'cui_str': 'Clomiphene citrate'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0018061', 'cui_str': 'Gonadotropin'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}]","[{'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0018061', 'cui_str': 'Gonadotropin'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0546859', 'cui_str': 'Clomiphene citrate'}, {'cui': 'C4709307', 'cui_str': '335'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0546824', 'cui_str': 'Intrauterine artificial insemination'}]","[{'cui': 'C0481667', 'cui_str': 'Live birth'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0009637', 'cui_str': 'Conception'}, {'cui': 'C0023175', 'cui_str': 'Lead'}]",666.0,0.218287,"Per additional live birth with gonadotropins, the ICER was €9709 (95% CI: €5117 to €25 302).","[{'ForeName': 'E M', 'Initials': 'EM', 'LastName': 'Bordewijk', 'Affiliation': 'Center for Reproductive Medicine Amsterdam UMC, University of Amsterdam, Meibergdreef 9, Amsterdam, Netherlands.'}, {'ForeName': 'N S', 'Initials': 'NS', 'LastName': 'Weiss', 'Affiliation': 'Center for Reproductive Medicine Amsterdam UMC, University of Amsterdam, Meibergdreef 9, Amsterdam, Netherlands.'}, {'ForeName': 'M J', 'Initials': 'MJ', 'LastName': 'Nahuis', 'Affiliation': 'Department of Obstetrics and Gynaecology, Noordwest Ziekenhuisgroep, Alkmaar, Netherlands.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Kwee', 'Affiliation': 'Department of Obstetrics and Gynaecology, Onze Lieve Vrouwe Gasthuis, Amsterdam, Netherlands.'}, {'ForeName': 'A F', 'Initials': 'AF', 'LastName': 'Lambeek', 'Affiliation': 'Department of Obstetrics and Gynaecology, IJsselland Hospital, Capelle aan den Ijssel, Netherlands.'}, {'ForeName': 'G A', 'Initials': 'GA', 'LastName': 'van Unnik', 'Affiliation': 'Department of Obstetrics and Gynaecology, Alrijne Hospital, Leiden, Netherlands.'}, {'ForeName': 'F P J', 'Initials': 'FPJ', 'LastName': 'Vrouenraets', 'Affiliation': 'Department of Obstetrics and Gynaecology, Zuyderland Medical Center, Heerlen, Netherlands.'}, {'ForeName': 'B J', 'Initials': 'BJ', 'LastName': 'Cohlen', 'Affiliation': 'Department of Obstetrics and Gynaecology, Isala Fertility Center, Zwolle, Netherlands.'}, {'ForeName': 'T A M', 'Initials': 'TAM', 'LastName': 'van de Laar-van Asseldonk', 'Affiliation': 'Department of Obstetrics and Gynaecology, Elkerliek Hospital, Helmond, Netherlands.'}, {'ForeName': 'C B', 'Initials': 'CB', 'LastName': 'Lambalk', 'Affiliation': 'Center for Reproductive Medicine Amsterdam UMC, VU University, De Boelelaan 1117, Amsterdam, Netherlands.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Goddijn', 'Affiliation': 'Center for Reproductive Medicine Amsterdam UMC, University of Amsterdam, Meibergdreef 9, Amsterdam, Netherlands.'}, {'ForeName': 'P G', 'Initials': 'PG', 'LastName': 'Hompes', 'Affiliation': 'Center for Reproductive Medicine Amsterdam UMC, VU University, De Boelelaan 1117, Amsterdam, Netherlands.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'van der Veen', 'Affiliation': 'Center for Reproductive Medicine Amsterdam UMC, University of Amsterdam, Meibergdreef 9, Amsterdam, Netherlands.'}, {'ForeName': 'B W J', 'Initials': 'BWJ', 'LastName': 'Mol', 'Affiliation': 'Department of Obstetrics and Gynaecology, Monash University, Melbourne, Australia.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'van Wely', 'Affiliation': 'Center for Reproductive Medicine Amsterdam UMC, University of Amsterdam, Meibergdreef 9, Amsterdam, Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Human reproduction (Oxford, England)",['10.1093/humrep/deaa052'] 1995,32586361,"Transmuscular quadratus lumborum (TQL) block for laparoscopic colorectal surgery: study protocol for a double-blind, prospective randomized placebo-controlled trial.","BACKGROUND Thoracic epidural anesthesia is no longer considered the gold standard for perioperative analgesia in laparoscopic colorectal procedures. In the search for alternatives, the efficacy of the transverse abdominal plane (TAP) block and other abdominal wall blocks such as the transmuscular quadratus lumborum (TQL) block continues to be investigated for postoperative pain management. Most of the initial studies on TAP blocks reported positive effects; however, the amount of studies with negative outcomes is increasing, most probably due to the fact that the majority of abdominal wall blocks fail to mitigate visceral pain. The TQL block could prove attractive in the search for better postoperative pain relief after laparoscopic colorectal surgery. In several cadaveric studies of the TQL, a spread of dye into the thoracic paravertebral space, the intercostal spaces, and even the thoracic sympathetic trunk was reported. Given the advantage of possibly reaching the thoracic paravertebral space, the potential to reach nerves transmitting visceral pain, and the possible coverage of dermatomes T4-L1, we hypothesize that the TQL provides superior postoperative analgesia for laparoscopic colorectal surgery as compared to patient-controlled intravenous analgesia with morphine alone. METHODS AND DESIGN In this prospective, randomized, double-blind controlled clinical trial, 150 patients undergoing laparoscopic colorectal surgery will be included. Patients will be randomly allocated to two different analgesic strategies: a bilateral TQL with 30 ml ropivacaine 0.375% each on both sides, administered before induction of anesthesia, plus postoperative patient-controlled intravenous analgesia with morphine (TQL group, n = 75), or a bilateral TQL block with 30 ml saline each on both sides plus postoperative patient-controlled intravenous analgesia with morphine (placebo group, n = 75). Our primary outcome parameter will be the morphine consumption during the first 24 h postsurgery. Secondary endpoints include pain intensity as assessed with the numerical rating scale (NRS) for pain, time to return of intestinal function (defined as the time to first flatus and the time to the first postoperative intake of solid food), time to first mobilization, the incidence of postoperative nausea and vomiting during the first 24 h, length of stay on the post anesthesia care unit (PACU) and in the hospital, the extent of sensory block at two time points (admission to and discharge from the PACU), the doses of morphine IV as requested by the patient from the PCA pump, the total dosage of morphine administered IV, the need for and dose of rescue analgesics (ketamine, clonidine), free plasma ropivacaine levels after induction and at discharge from the PACU, and the incidence of adverse events during treatment (in particular, signs of local anesthetic systemic toxicity (LAST)). Epidural analgesia is no longer the standard of care for postoperative analgesia in laparoscopic colorectal surgery. Until now, the most effective analgesic strategy in these patients especially in an enhanced recovery program is still unknown. Several abdominal wall blocks (TAP, fascia transversalis plane block) are known to have an analgesic effect only on somatic pain. Recognizing the importance of procedure-specific pain management, we aim to investigate whether a transmuscular quadratus lumborum block delivers superior pain control in comparison to patient-controlled intravenous analgesia with morphine alone. TRIAL REGISTRATION EudraCT identifier 2019-002304-40. Registered on 17 September 2019.",2020,"Secondary endpoints include pain intensity as assessed with the numerical rating scale (NRS) for pain, time to return of intestinal function (defined as the time to first flatus and the time to the first postoperative intake of solid food), time to first mobilization, the incidence of postoperative nausea and vomiting during the first 24 h, length of stay on the post anesthesia care unit (PACU) and in the hospital, the extent of sensory block at two time points (admission to and discharge from the PACU), the doses of morphine IV as requested by the patient from the PCA pump, the total dosage of morphine administered IV, the need for and dose of rescue analgesics (ketamine, clonidine), free plasma ropivacaine levels after induction and at discharge from the PACU, and the incidence of adverse events during treatment (in particular, signs of local anesthetic systemic toxicity (LAST)).","['150 patients undergoing', 'laparoscopic colorectal surgery', 'after laparoscopic colorectal surgery']","['transmuscular quadratus lumborum block', 'Epidural analgesia', 'laparoscopic colorectal surgery', 'Transmuscular quadratus lumborum (TQL) block', 'placebo', 'bilateral TQL with 30\u2009ml ropivacaine 0.375% each on both sides, administered before induction of anesthesia, plus postoperative patient-controlled intravenous analgesia with morphine (TQL group, n\u2009=\u200975), or a bilateral TQL block with 30\u2009ml saline each on both sides plus postoperative patient-controlled intravenous analgesia with morphine (placebo', 'TQL', 'morphine']","['total dosage of morphine administered IV, the need for and dose of rescue analgesics (ketamine, clonidine), free plasma ropivacaine levels', 'local anesthetic systemic toxicity (LAST', 'pain intensity as assessed with the numerical rating scale (NRS) for pain, time to return of intestinal function (defined as the time to first flatus and the time to the first postoperative intake of solid food), time to first mobilization, the incidence of postoperative nausea and vomiting during the first 24\u2009h, length of stay on the post anesthesia care unit (PACU) and in the hospital, the extent of sensory block at two time points (admission to and discharge from the PACU', 'morphine consumption during the first 24\u2009h postsurgery', 'postoperative pain relief', 'incidence of adverse events']","[{'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0009369', 'cui_str': 'Colorectal surgery'}]","[{'cui': 'C0224380', 'cui_str': 'Structure of quadratus lumborum muscle'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0002769', 'cui_str': 'Epidural analgesia'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0009369', 'cui_str': 'Colorectal surgery'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C4517455', 'cui_str': '0.375'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0853212', 'cui_str': 'Induction of anaesthesia'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0009014', 'cui_str': 'Clonidine'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C4761262', 'cui_str': 'Local anaesthetic systemic toxicity'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0453855', 'cui_str': 'Solid food'}, {'cui': 'C0185112', 'cui_str': 'Mobilization'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0520909', 'cui_str': 'Postoperative nausea and vomiting'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0034871', 'cui_str': 'Postoperative anesthesia care unit'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0439792', 'cui_str': 'Extent'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",150.0,0.231922,"Secondary endpoints include pain intensity as assessed with the numerical rating scale (NRS) for pain, time to return of intestinal function (defined as the time to first flatus and the time to the first postoperative intake of solid food), time to first mobilization, the incidence of postoperative nausea and vomiting during the first 24 h, length of stay on the post anesthesia care unit (PACU) and in the hospital, the extent of sensory block at two time points (admission to and discharge from the PACU), the doses of morphine IV as requested by the patient from the PCA pump, the total dosage of morphine administered IV, the need for and dose of rescue analgesics (ketamine, clonidine), free plasma ropivacaine levels after induction and at discharge from the PACU, and the incidence of adverse events during treatment (in particular, signs of local anesthetic systemic toxicity (LAST)).","[{'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Coppens', 'Affiliation': 'Department of Anaesthesiology, University Hospitals of the KU Leuven, Herestraat 49, B-3000, Leuven, Belgium. Steve.coppens@uzleuven.be.'}, {'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Rex', 'Affiliation': 'Department of Anaesthesiology, University Hospitals of the KU Leuven, Herestraat 49, B-3000, Leuven, Belgium.'}, {'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Fieuws', 'Affiliation': 'Interuniversity Institute for Biostatistics and Statistical Bioinformatics, KU Leuven-University of Leuven & Universiteit Hasselt, Kapucijnenvoer 35, B-3000, Leuven, Belgium.'}, {'ForeName': 'Arne', 'Initials': 'A', 'LastName': 'Neyrinck', 'Affiliation': 'Department of Anaesthesiology, University Hospitals of the KU Leuven, Herestraat 49, B-3000, Leuven, Belgium.'}, {'ForeName': 'Andre', 'Initials': 'A', 'LastName': ""D'Hoore"", 'Affiliation': 'Department of Abdominal Surgery, KU Leuven-University Hospitals of Leuven, Herestraat 49, B-3000, Leuven, Belgium.'}, {'ForeName': 'Geertrui', 'Initials': 'G', 'LastName': 'Dewinter', 'Affiliation': 'Department of Anaesthesiology, University Hospitals of the KU Leuven, Herestraat 49, B-3000, Leuven, Belgium.'}]",Trials,['10.1186/s13063-020-04525-6'] 1996,32586362,"Evaluation of the SPIRIT Integrated Suicide Prevention Programme: study protocol for a cluster-randomised controlled trial in rural Gujarat, India.","BACKGROUND Suicide is a major public health challenge globally and specifically in India where 36.6% and 24.3% of all suicides worldwide occur in women and men, respectively. The United Nations Sustainable Development Goals uses suicide rate as one of two indicators for Target 3.4, aimed at reducing these deaths by one third by 2030. India has no examples of large-scale implementation of evidence-based interventions to prevent suicide; however, there is a sizeable evidence base to draw on for suicide prevention strategies that have been piloted in India or proven to be effective regionally or internationally. METHOD The SPIRIT study is designed as a cluster-randomized superiority trial and uses mixed methods to evaluate the implementation, effectiveness and costs of an integrated suicide prevention programme consisting of three integrated interventions including (1) a secondary-school-based intervention to reduce suicidal ideation among adolescents, (2) a community storage facility intervention to reduce access to pesticides and (3) training for community health workers in recognition, management, and appropriate referral of people identified with high suicidal risk. DISCUSSION Combining three evidence-based interventions that tackle suicide among high-risk groups may generate a synergistic impact in reducing suicides at the community level in rural areas in India. Examination of implementation processes throughout the trial will also help to prepare a roadmap for policymakers and researchers looking to implement suicide prevention interventions in other countries and at scale. TRIAL REGISTRATION Clinical Trial Registry of Indian Council of Medical Research, India: CTRI/2017/04/008313. Registered on 7 April 2017. http://ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=18256&EncHid=&userName=SPIRIT Trial registry was last modified on 28 June 2019.",2020,Combining three evidence-based interventions that tackle suicide among high-risk groups may generate a synergistic impact in reducing suicides at the community level in rural areas in India.,"['community health workers in recognition, management, and appropriate referral of people identified with high suicidal risk', 'rural Gujarat, India']","['community storage facility intervention to reduce access to pesticides and (3) training', 'integrated suicide prevention programme consisting of three integrated interventions including (1) a secondary-school-based intervention']",[],"[{'cui': 'C0009467', 'cui_str': 'Community Health Aides'}, {'cui': 'C0524637', 'cui_str': 'Recognition'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0438696', 'cui_str': 'Suicidal'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0021201', 'cui_str': 'India'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C1698986', 'cui_str': 'Storage'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0031253', 'cui_str': 'Pesticide'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0204732', 'cui_str': 'Suicide prevention'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0036530', 'cui_str': 'Secondary school'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]",[],,0.166794,Combining three evidence-based interventions that tackle suicide among high-risk groups may generate a synergistic impact in reducing suicides at the community level in rural areas in India.,"[{'ForeName': 'Soumitra', 'Initials': 'S', 'LastName': 'Pathare', 'Affiliation': 'Centre for Mental Health Law and Policy, Indian Law Society, Law College Road, Pune, 411004, India. spathare@cmhlp.org.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Shields-Zeeman', 'Affiliation': 'Netherlands Institute for Mental health and Addiction (Trimbos Institute), Da Costakade 45, Utrecht, 3521 VT, the Netherlands.'}, {'ForeName': 'Lakshmi', 'Initials': 'L', 'LastName': 'Vijayakumar', 'Affiliation': 'SNEHA Suicide Prevention Centre, Chennai, India.'}, {'ForeName': 'Deepa', 'Initials': 'D', 'LastName': 'Pandit', 'Affiliation': 'Centre for Mental Health Law and Policy, Indian Law Society, Law College Road, Pune, 411004, India.'}, {'ForeName': 'Renuka', 'Initials': 'R', 'LastName': 'Nardodkar', 'Affiliation': 'Centre for Mental Health Law and Policy, Indian Law Society, Law College Road, Pune, 411004, India.'}, {'ForeName': 'Susmita', 'Initials': 'S', 'LastName': 'Chatterjee', 'Affiliation': 'George Institute for Global Health Elegance Tower, 311-312, Third Floor, JasolaVihar, New Delhi, 110025, India.'}, {'ForeName': 'Jasmine', 'Initials': 'J', 'LastName': 'Kalha', 'Affiliation': 'Centre for Mental Health Law and Policy, Indian Law Society, Law College Road, Pune, 411004, India.'}, {'ForeName': 'Sadhvi', 'Initials': 'S', 'LastName': 'Krishnamoorthy', 'Affiliation': 'Centre for Mental Health Law and Policy, Indian Law Society, Law College Road, Pune, 411004, India.'}, {'ForeName': 'Nikhil', 'Initials': 'N', 'LastName': 'Jain', 'Affiliation': 'Centre for Mental Health Law and Policy, Indian Law Society, Law College Road, Pune, 411004, India.'}, {'ForeName': 'Arjun', 'Initials': 'A', 'LastName': 'Kapoor', 'Affiliation': 'Centre for Mental Health Law and Policy, Indian Law Society, Law College Road, Pune, 411004, India.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Shahjahan', 'Affiliation': 'Bangladesh Centre for Communication Programs, Dhaka, Bangladesh.'}, {'ForeName': 'Ajay', 'Initials': 'A', 'LastName': 'Chauhan', 'Affiliation': 'Hospital for Mental Health, Ahmedabad, India.'}, {'ForeName': 'Filip', 'Initials': 'F', 'LastName': 'Smit', 'Affiliation': 'Netherlands Institute for Mental health and Addiction (Trimbos Institute), Da Costakade 45, Utrecht, 3521 VT, the Netherlands.'}]",Trials,['10.1186/s13063-020-04472-2'] 1997,32586366,Efficacy and safety of umbilical cord mesenchymal stem cells in treatment of cesarean section skin scars: a randomized clinical trial.,"BACKGROUND Pathological skin scars, caused by cesarean section, affected younger mothers esthetically and psychosocially and to some extent frustrated obstetricians and dermatologists. Umbilical cord mesenchymal stem cells (UC-MSCs), as a population of multipotent cells, are abundant in human tissues, providing several possibilities for their effects on skin scar tissues. Herein, we performed a randomized, double-blind, placebo-controlled, three-arm clinical trial, aiming to assess the efficacy and safety of UC-MSCs in the treatment of cesarean section skin scars among primiparous singleton pregnant women. METHODS Ninety primiparous singleton pregnant women undergoing elective cesarean section were randomly allocated to receive placebo, low-dose (3 × 10 6 cells), or high-dose (6 × 10 6 cells) transdermal hydrogel UC-MSCs on the surface of the skin incision. The primary outcome was cesarean section skin scars followed after the sixth month, assessed by the Vancouver Scar Scale (VSS). RESULTS All the participants completed their trial of the primary outcome according to the protocol. The mean score of estimated total VSS was 5.52 in all participants at the sixth-month follow-up, with 6.43 in the placebo group, 5.18 in the low-dose group, and 4.71 in the high-dose group, respectively. No significant difference was found between-group in the mean scores for VSS at the sixth month. Additional prespecified secondary outcomes were not found with significant differences among groups either. No obvious side effects or adverse effects were reported in any of the three arms. CONCLUSION This randomized clinical trial showed that UC-MSCs did not demonstrate the effects of improvement of cesarean section skin scars. TRIAL REGISTRATION ClinicalTrials.gov identifier, NCT02772289. Registered on 13 May 2016.",2020,"No obvious side effects or adverse effects were reported in any of the three arms. ","['primiparous singleton pregnant women', 'Ninety primiparous singleton pregnant women undergoing elective cesarean section', 'cesarean section skin scars']","['UC-MSCs', 'placebo, low-dose (3\u2009×\u200910 6 cells), or high-dose (6\u2009×\u200910 6 cells) transdermal hydrogel UC-MSCs', 'umbilical cord mesenchymal stem cells', 'Umbilical cord mesenchymal stem cells (UC-MSCs', 'placebo']","['cesarean section skin scars', 'Efficacy and safety', 'efficacy and safety', 'Vancouver Scar Scale (VSS', 'mean score of estimated total VSS', 'adverse effects']","[{'cui': 'C0033150', 'cui_str': 'Para 1'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0473296', 'cui_str': 'Elective cesarean section'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0008767', 'cui_str': 'Scarring'}]","[{'cui': 'C0041633', 'cui_str': 'Umbilical cord structure'}, {'cui': 'C1257975', 'cui_str': 'Mesenchymal stem cell'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0040652', 'cui_str': 'Transdermal route'}, {'cui': 'C0063083', 'cui_str': 'Hydrogel'}]","[{'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0008767', 'cui_str': 'Scarring'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",90.0,0.521774,"No obvious side effects or adverse effects were reported in any of the three arms. ","[{'ForeName': 'Dazhi', 'Initials': 'D', 'LastName': 'Fan', 'Affiliation': 'Foshan Institute of Fetal Medicine, Affiliated Foshan Maternity & Child Healthcare Hospital, Southern Medical University, 11 Renminxi Road, Foshan, 528000, Guangdong, China.'}, {'ForeName': 'Meng', 'Initials': 'M', 'LastName': 'Zeng', 'Affiliation': 'Department of Obstetrics, Affiliated Foshan Maternity & Child Healthcare Hospital, Southern Medical University, 11 Renminxi Road, Foshan, 528000, Guangdong, China.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Xia', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health, Anhui Medical University, Hefei, 230032, Anhui, China.'}, {'ForeName': 'Shuzhen', 'Initials': 'S', 'LastName': 'Wu', 'Affiliation': 'Department of Obstetrics, Affiliated Foshan Maternity & Child Healthcare Hospital, Southern Medical University, 11 Renminxi Road, Foshan, 528000, Guangdong, China.'}, {'ForeName': 'Shaoxin', 'Initials': 'S', 'LastName': 'Ye', 'Affiliation': 'Foshan Institute of Fetal Medicine, Affiliated Foshan Maternity & Child Healthcare Hospital, Southern Medical University, 11 Renminxi Road, Foshan, 528000, Guangdong, China.'}, {'ForeName': 'Jiaming', 'Initials': 'J', 'LastName': 'Rao', 'Affiliation': 'Foshan Institute of Fetal Medicine, Affiliated Foshan Maternity & Child Healthcare Hospital, Southern Medical University, 11 Renminxi Road, Foshan, 528000, Guangdong, China.'}, {'ForeName': 'Dongxin', 'Initials': 'D', 'LastName': 'Lin', 'Affiliation': 'Foshan Institute of Fetal Medicine, Affiliated Foshan Maternity & Child Healthcare Hospital, Southern Medical University, 11 Renminxi Road, Foshan, 528000, Guangdong, China.'}, {'ForeName': 'Huishan', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Foshan Institute of Fetal Medicine, Affiliated Foshan Maternity & Child Healthcare Hospital, Southern Medical University, 11 Renminxi Road, Foshan, 528000, Guangdong, China.'}, {'ForeName': 'Huiting', 'Initials': 'H', 'LastName': 'Ma', 'Affiliation': 'Foshan Institute of Fetal Medicine, Affiliated Foshan Maternity & Child Healthcare Hospital, Southern Medical University, 11 Renminxi Road, Foshan, 528000, Guangdong, China.'}, {'ForeName': 'Zhongchao', 'Initials': 'Z', 'LastName': 'Han', 'Affiliation': 'State Key Laboratory of Experimental Hematology, Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Tianjin, 300020, China. hanzhongchao@hotmail.com.'}, {'ForeName': 'Xiaoling', 'Initials': 'X', 'LastName': 'Guo', 'Affiliation': 'Foshan Institute of Fetal Medicine, Affiliated Foshan Maternity & Child Healthcare Hospital, Southern Medical University, 11 Renminxi Road, Foshan, 528000, Guangdong, China. fsguoxl@163.com.'}, {'ForeName': 'Zhengping', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'Foshan Institute of Fetal Medicine, Affiliated Foshan Maternity & Child Healthcare Hospital, Southern Medical University, 11 Renminxi Road, Foshan, 528000, Guangdong, China. liuzphlk81@outlook.com.'}]",Stem cell research & therapy,['10.1186/s13287-020-01695-7'] 1998,32586393,The ProBio trial: molecular biomarkers for advancing personalized treatment decision in patients with metastatic castration-resistant prostate cancer.,"BACKGROUND Multiple therapies exist for patients with metastatic castration-resistant prostate cancer (mCRPC). However, their improvement on progression-free survival (PFS) remains modest, potentially explained by tumor molecular heterogeneity. Several prognostic molecular biomarkers have been identified for mCRPC that may have predictive potential to guide treatment selection and prolong PFS. We designed a platform trial to test this hypothesis. METHODS The Prostate-Biomarker (ProBio) study is a multi-center, outcome-adaptive, multi-arm, biomarker-driven platform trial for tailoring treatment decisions for men with mCRPC. Treatment decisions in the experimental arms are based on biomarker signatures defined as mutations in certain genes/pathways suggested in the scientific literature to be important for treatment response in mCRPC. The biomarker signatures are determined by targeted sequencing of circulating tumor and germline DNA using a panel specifically designed for mCRPC. DISCUSSION Patients are stratified based on the sequencing results and randomized to either current clinical practice (control), where the treating physician decides treatment, or to molecularly driven treatment selection based on the biomarker profile. Outcome-adaptive randomization is implemented to early identify promising treatments for a biomarker signature. Biomarker signature-treatment combinations graduate from the platform when they demonstrate 85% probability of improving PFS compared to the control arm. Graduated combinations are further evaluated in a seamless confirmatory trial with fixed randomization. The platform design allows for new drugs and biomarkers to be introduced in the study. CONCLUSIONS The ProBio design allows promising treatment-biomarker combinations to quickly graduate from the platform and be confirmed for rapid implementation in clinical care. TRIAL REGISTRATION ClinicalTrials.gov Identifier NCT03903835. Date of registration: April 4, 2019. Status: Recruiting.",2020,Biomarker signature-treatment combinations graduate from the platform when they demonstrate 85% probability of improving PFS compared to the control arm.,"['patients with metastatic castration-resistant prostate cancer', 'patients with metastatic castration-resistant prostate cancer (mCRPC', 'Status', 'men with mCRPC']",[],['progression-free survival (PFS'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4721208', 'cui_str': 'Metastatic castration-resistant prostate cancer'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0025266', 'cui_str': 'Man'}]",[],"[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",,0.0621446,Biomarker signature-treatment combinations graduate from the platform when they demonstrate 85% probability of improving PFS compared to the control arm.,"[{'ForeName': 'Alessio', 'Initials': 'A', 'LastName': 'Crippa', 'Affiliation': 'Department of Medical Epidemiology and Biostatistics, Karolinska Institutet, Stockholm, Sweden. alessio.crippa@ki.se.'}, {'ForeName': 'Bram', 'Initials': 'B', 'LastName': 'De Laere', 'Affiliation': 'Department of Medical Epidemiology and Biostatistics, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Discacciati', 'Affiliation': 'Department of Medical Epidemiology and Biostatistics, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Berit', 'Initials': 'B', 'LastName': 'Larsson', 'Affiliation': 'Department of Medical Epidemiology and Biostatistics, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Jason T', 'Initials': 'JT', 'LastName': 'Connor', 'Affiliation': 'University of Central Florida College of Medicine, Orlando, FL, USA.'}, {'ForeName': 'Erin E', 'Initials': 'EE', 'LastName': 'Gabriel', 'Affiliation': 'Department of Medical Epidemiology and Biostatistics, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Camilla', 'Initials': 'C', 'LastName': 'Thellenberg', 'Affiliation': 'Department of Radiation Sciences and Oncology, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Elin', 'Initials': 'E', 'LastName': 'Jänes', 'Affiliation': 'Länssjukhuset Sundsvall Härnösand, Sundsvall, Sweden.'}, {'ForeName': 'Gunilla', 'Initials': 'G', 'LastName': 'Enblad', 'Affiliation': 'Department of Immunology, Genetics and Pathology, Uppsala Universitet, Uppsala, Sweden.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Ullen', 'Affiliation': 'Department of Oncology-Pathology, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Hjälm-Eriksson', 'Affiliation': 'Capio St. Görans Hospital, Stockholm, Sweden.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Oldenburg', 'Affiliation': 'Division of Medicine, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Piet', 'Initials': 'P', 'LastName': 'Ost', 'Affiliation': 'Department of Radiotherapy and Experimental Cancer Research, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Lindberg', 'Affiliation': 'Department of Medical Epidemiology and Biostatistics, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Eklund', 'Affiliation': 'Department of Medical Epidemiology and Biostatistics, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Grönberg', 'Affiliation': 'Department of Medical Epidemiology and Biostatistics, Karolinska Institutet, Stockholm, Sweden.'}]",Trials,['10.1186/s13063-020-04515-8'] 1999,32589230,Safety and Efficacy of Apixaban vs Enoxaparin for Preventing Postoperative Venous Thromboembolism in Women Undergoing Surgery for Gynecologic Malignant Neoplasm: A Randomized Clinical Trial.,"Importance Current guidelines recommend a 28-day course of enoxaparin for thromboprophylaxis after surgery for gynecologic cancer. The high cost of this medication and the low adherence rates observed in prior studies provide an opportunity to benefit patients by demonstrating the safety of a more cost-effective, easier to use thromboprophylactic. Objective To investigate the safety and efficacy of an oral treatment alternative for thromboprophylaxis in postoperative patients with gynecologic cancer. Design, Setting, and Participants This was a patient-based, multicenter, open-label, blinded, end point, randomized clinical trial conducted May 2015 to March 2019 in outpatient and inpatient gynecologic oncology settings. Women undergoing surgery for suspected or confirmed gynecologic cancer were approached for recruitment. The trial compared rates of major bleeding and clinically relevant nonmajor bleeding events during a 90-day follow-up period in patients taking apixaban or enoxaparin for postoperative thromboprophylaxis using a modified intent-to-treat analysis. Data analysis was performed from October to December 2019. Interventions Women were randomized to 28 days of apixaban (2.5 mg orally twice daily) or enoxaparin (40 mg subcutaneously daily). Main Outcomes and Measures The primary outcome was major bleeding and clinically relevant nonmajor bleeding events. Secondary outcomes included incidence of venous thromboembolic events, adverse events, medication adherence, participant quality of life, and medication satisfaction. Results Of 500 women recruited for the study, 400 were enrolled and randomized (median age, 58.0 years; range, 18.0-89.0 years); 204 received apixaban and 196 received enoxaparin. Treatment groups did not differ in terms of race/ethnicity, cancer stage, or surgery modality (open vs robotic). There were no statistically significant differences between the apixaban and enoxaparin groups in terms of rates of major bleeding events (1 patient [0.5%] vs 1 patient [0.5%]; odds ratio [OR], 1.04; 95% CI, 0.07-16.76; P > .99), clinically relevant nonmajor bleeding events (12 patients [5.4%] vs 19 patients [9.7%]; OR, 1.88; 95% CI, 0.87-4.1; P = .11), venous thromboembolic events (2 patients [1.0%] vs 3 patients [1.5%]; OR, 1.57; 95% CI, 0.26-9.50; P = .68), adverse events, medication adherence, or quality of life between the groups. Participant satisfaction was significantly greater in the apixaban group with regard to ease of taking the medication (186 patients [98.9%] vs 110 patients [58.8%]; OR, 0.06; 95% CI, 0.01-0.25; P < .001) and pain associated with taking the medication (4 patients [2.1%] vs 92 patients [49.2%]; OR, 9.20; 95% CI, 2.67-31.82; P < .001). Conclusions and Relevance These findings suggest that oral apixaban is a potentially safe, less painful, and easier-to-take alternative to subcutaneous enoxaparin for thromboprophylaxis after surgery for gynecologic cancer. The efficacy of apixaban to prevent venous thromboembolic events is hypothesized as being equivalent. Trial Registration ClinicalTrials.gov Identifier: NCT02366871.",2020,"There were no statistically significant differences between the apixaban and enoxaparin groups in terms of rates of major bleeding events (1 patient [0.5%] vs 1 patient [0.5%]; odds ratio [OR], 1.04; 95% CI, 0.07-16.76; P > .99), clinically relevant nonmajor bleeding events (12 patients [5.4%] vs 19 patients [9.7%];","['postoperative patients with gynecologic cancer', 'Interventions\n\n\nWomen', 'gynecologic cancer', 'Women undergoing surgery for suspected or confirmed gynecologic cancer', '2015 to March 2019 in outpatient and inpatient gynecologic oncology settings', '500 women recruited for the study, 400 were enrolled and randomized (median age, 58.0 years; range, 18.0-89.0 years); 204 received', 'Women Undergoing Surgery for Gynecologic Malignant Neoplasm']","['apixaban or enoxaparin', 'apixaban', 'Apixaban vs Enoxaparin', 'enoxaparin', 'oral apixaban']","['Participant satisfaction', 'rates of major bleeding and clinically relevant nonmajor bleeding events', 'race/ethnicity, cancer stage, or surgery modality', 'Postoperative Venous Thromboembolism', 'clinically relevant nonmajor bleeding events', 'venous thromboembolic events', 'safety and efficacy', 'pain', 'incidence of venous thromboembolic events, adverse events, medication adherence, participant quality of life, and medication satisfaction', 'major bleeding and clinically relevant nonmajor bleeding events', 'rates of major bleeding events', 'adverse events, medication adherence, or quality of life']","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0699889', 'cui_str': 'Female reproductive neoplasm malignant NOS'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C1321164', 'cui_str': 'Gynecological oncology'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0205480', 'cui_str': 'Gynecologic'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}]","[{'cui': 'C1831808', 'cui_str': 'apixaban'}, {'cui': 'C0206460', 'cui_str': 'Enoxaparin'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0034510', 'cui_str': 'Racial group'}, {'cui': 'C0015031', 'cui_str': 'Ethnic group'}, {'cui': 'C0027646', 'cui_str': 'Cancer staging'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C1861172', 'cui_str': 'Thromboembolism, Venous'}, {'cui': 'C0042449', 'cui_str': 'Venous structure'}, {'cui': 'C0040038', 'cui_str': 'Thromboembolus'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]",400.0,0.236392,"There were no statistically significant differences between the apixaban and enoxaparin groups in terms of rates of major bleeding events (1 patient [0.5%] vs 1 patient [0.5%]; odds ratio [OR], 1.04; 95% CI, 0.07-16.76; P > .99), clinically relevant nonmajor bleeding events (12 patients [5.4%] vs 19 patients [9.7%];","[{'ForeName': 'Saketh R', 'Initials': 'SR', 'LastName': 'Guntupalli', 'Affiliation': 'Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, University of Colorado School of Medicine at Denver, Aurora.'}, {'ForeName': 'Alyse', 'Initials': 'A', 'LastName': 'Brennecke', 'Affiliation': 'Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, University of Colorado School of Medicine at Denver, Aurora.'}, {'ForeName': 'Kian', 'Initials': 'K', 'LastName': 'Behbakht', 'Affiliation': 'Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, University of Colorado School of Medicine at Denver, Aurora.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Tayebnejad', 'Affiliation': 'Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, University of Colorado School of Medicine at Denver, Aurora.'}, {'ForeName': 'Christopher A', 'Initials': 'CA', 'LastName': 'Breed', 'Affiliation': 'Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, University of Colorado School of Medicine at Denver, Aurora.'}, {'ForeName': 'Lisa Marie', 'Initials': 'LM', 'LastName': 'Babayan', 'Affiliation': 'Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, University of Colorado School of Medicine at Denver, Aurora.'}, {'ForeName': 'Georgina', 'Initials': 'G', 'LastName': 'Cheng', 'Affiliation': 'Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, University of Colorado School of Medicine at Denver, Aurora.'}, {'ForeName': 'Amin A', 'Initials': 'AA', 'LastName': 'Ramzan', 'Affiliation': 'Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, University of Colorado School of Medicine at Denver, Aurora.'}, {'ForeName': 'Lindsay J', 'Initials': 'LJ', 'LastName': 'Wheeler', 'Affiliation': 'Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, University of Colorado School of Medicine at Denver, Aurora.'}, {'ForeName': 'Bradley R', 'Initials': 'BR', 'LastName': 'Corr', 'Affiliation': 'Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, University of Colorado School of Medicine at Denver, Aurora.'}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Lefkowits', 'Affiliation': 'Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, University of Colorado School of Medicine at Denver, Aurora.'}, {'ForeName': 'Jeanelle', 'Initials': 'J', 'LastName': 'Sheeder', 'Affiliation': 'Division of Family Planning, Department of Obstetrics and Gynecology, University of Colorado School of Medicine at Denver, Aurora.'}, {'ForeName': 'Koji', 'Initials': 'K', 'LastName': 'Matsuo', 'Affiliation': 'Keck School of Medicine, Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, University of Southern California, Los Angeles.'}, {'ForeName': 'Dina', 'Initials': 'D', 'LastName': 'Flink', 'Affiliation': 'Division of Gynecologic Oncology, Department of Obstetrics and Gynecology, University of Colorado School of Medicine at Denver, Aurora.'}]",JAMA network open,['10.1001/jamanetworkopen.2020.7410'] 2000,32589237,Effects of catheter orifice configuration (triple-hole versus end-hole) in continuous infraclavicular brachial plexus block on analgesia after upper limb surgery.,"BACKGROUND The configuration of a nerve block catheter may affect the local anesthetic spread in epidural analgesia and continuous peripheral nerve blocks. This prospective and randomized study aims to compare the multi-orifice nerve block catheter with an end-hole catheter in ultrasound-guided continuous infraclavicular brachial plexus block (BPB) in terms of providing postoperative analgesia for the orthopedic upper limb surgery below the shoulder. The primary outcome measure was mean pain scores. Secondary outcome measures were the consumption of rescue analgesic and the amount of local anesthetics delivered by a Patient-Controlled Analgesia (PCA) device. METHODS A total of 58 adult patients who underwent orthopedic upper limb surgery below the shoulder were randomly assigned into two groups: group end-hole catheter (EHC) (n=31) and group multi-orifice catheter (MOC) (n=27). All patients received a single-shot infraclavicular BPB using 100 mg lidocaine 2% and 75 mg bupivacaine 0.5% administrated through a Tuohy needle. Then, a multi-orifice (triple-hole) nerve catheter was placed in the group MOC and an end-hole (one-hole) catheter in the group EHC at the same location. Bupivacaine 0.125% was infused through the catheters via PCA (infusion rate: 2 mlh-1, automated regular bolus: 5 mlh-1, patient-controlled bolus: 3 ml, lock-out time: 1 hour, 4 hours limit: 40 ml). Pain intensity was evaluated using a visual analogue scale (VAS). RESULTS Mean VAS scores were higher in group EHC than group MOC in the first postoperative day (p=0.001). Mean rescue analgesic consumption, the number of bolus demand on PCA, PCA bolus demand dose, and total PCA dose were higher in group EHC than group MOC during the first postoperative day (p<0.05). CONCLUSION It is concluded that the use of MHC is more effective than EHC for continuous infraclavicular brachial plexus blocks in providing postoperative pain relief during the first 24 hours.",2020,"RESULTS Mean VAS scores were higher in group EHC than group MOC in the first postoperative day (p=0.001).","['58 adult patients who underwent orthopedic upper limb surgery below the shoulder', 'continuous infraclavicular brachial plexus block on analgesia after upper limb surgery', 'orthopedic upper limb surgery below the shoulder']","['EHC', 'catheter orifice configuration (triple-hole versus end-hole', 'Bupivacaine', 'bupivacaine', 'group end-hole catheter (EHC) (n=31) and group multi-orifice catheter (MOC) ', 'lidocaine', 'multi-orifice nerve block catheter with an end-hole catheter in ultrasound-guided continuous infraclavicular brachial plexus block (BPB', 'MHC']","['visual analogue scale (VAS', 'Pain intensity', 'consumption of rescue analgesic and the amount of local anesthetics delivered by a Patient-Controlled Analgesia (PCA) device', 'mean pain scores', 'Mean rescue analgesic consumption, the number of bolus demand on PCA, PCA bolus demand dose, and total PCA dose', 'Mean VAS scores', 'postoperative pain relief']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0394700', 'cui_str': 'Brachial plexus block by infraclavicular approach'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}]","[{'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0444567', 'cui_str': 'Ostium'}, {'cui': 'C0449830', 'cui_str': 'With configuration'}, {'cui': 'C0205174', 'cui_str': 'Triple'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0027741', 'cui_str': 'Nerve block'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0394700', 'cui_str': 'Brachial plexus block by infraclavicular approach'}, {'cui': 'C0394697', 'cui_str': 'Injection of anesthetic agent into brachial plexus'}, {'cui': 'C0024518', 'cui_str': 'Major histocompatibility complex'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia'}, {'cui': 'C0078944', 'cui_str': 'Patient controlled analgesia'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}]",58.0,0.068495,"RESULTS Mean VAS scores were higher in group EHC than group MOC in the first postoperative day (p=0.001).","[{'ForeName': 'Mehmet Burak', 'Initials': 'MB', 'LastName': 'Eskin', 'Affiliation': 'Department of Anesthesiology and Reanimation, University of Health Sciences, Gülhane Faculty of Medicine, Ankara -Turkey.'}, {'ForeName': 'Ayşegül', 'Initials': 'A', 'LastName': 'Ceylan', 'Affiliation': 'Department of Anesthesiology and Reanimation, Gülhane Training and Research Hospital, Ankara-Turkey.'}]",Ulusal travma ve acil cerrahi dergisi = Turkish journal of trauma & emergency surgery : TJTES,['10.14744/tjtes.2020.03302'] 2001,32589242,An investigation into the effects of hemodynamic changes on the patient's clinical condition during the treatment of patients undergoing aneurysmal subarachnoid hemorrhage.,"BACKGROUND In this study, we investigated the hemodynamic changes in patients with aneurysmal subarachnoid hemorrhage (aSAH) during the intensive care unit and the effects of PiCCO on the hemodynamic clinical course during hydration and hypertension treatment. METHODS In our study, 15 adult aSAH patients, whose aneurysm had been treated by surgery or coiling, were examined for the signs of vasospasm in between the dates 03/01/2015 and 01/03/2016. The PICCO measurement was made at least twice in a day. Positive daily fluid balance was attempted to be at least 1000 mL and the value of the Global end-diastolic index (GEDI) was targeted to 680 to 800 mL/m2 for each patient. The values of mean arterial pressure (MAP), systolic arterial pressure (SAP), heart rate (HR), central venous pressure (CVP), and cardiac index (CI), GEDI, systemic vascular resistance index (SVRI), extravascular lung water index (ELWI) measured by PiCCO, and daily neurological outcome of patients and GCS values were recorded. RESULTS It had been observed that CVP value was randomly changing during the volume therapy, but the GEDI value determined by thermodilution was consistent. A positive correlation was detected between the period of reaching the hospital and the first measured value of SVRI. Low GEDI value was detected as a risk factor in the perspective of vasospasm, but an ideal GEDI value could not be determined. CONCLUSION GEDI values were correlated with daily fluid balance. While low GEDI value was found as a risk factor, we could not determine an ideal GEDI value.",2020,"The values of mean arterial pressure (MAP), systolic arterial pressure (SAP), heart rate (HR), central venous pressure (CVP), and cardiac index (CI), GEDI, systemic vascular resistance index (SVRI), extravascular lung water index (ELWI) measured by PiCCO, and daily neurological outcome of patients and GCS values were recorded. ","['15 adult aSAH patients', 'patients with aneurysmal subarachnoid hemorrhage (aSAH', 'patients undergoing aneurysmal subarachnoid hemorrhage']",['PiCCO'],"['values of mean arterial pressure (MAP), systolic arterial pressure (SAP), heart rate (HR), central venous pressure (CVP), and cardiac index (CI), GEDI, systemic vascular resistance index (SVRI), extravascular lung water index (ELWI) measured by PiCCO, and daily neurological outcome of patients and GCS values', 'signs of vasospasm', 'GEDI values', 'Positive daily fluid balance']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0751530', 'cui_str': 'Subarachnoid Hemorrhage, Aneurysmal'}]",[],"[{'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0199666', 'cui_str': 'Measurement of central venous pressure'}, {'cui': 'C0428776', 'cui_str': 'Cardiac index'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0456260', 'cui_str': 'Systemic vascular resistance index'}, {'cui': 'C0015380', 'cui_str': 'Lung Water, Extravascular'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1522376', 'cui_str': 'GCLC protein, human'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0042396', 'cui_str': 'Vascular constriction'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0016284', 'cui_str': 'Fluid balance'}]",15.0,0.0389726,"The values of mean arterial pressure (MAP), systolic arterial pressure (SAP), heart rate (HR), central venous pressure (CVP), and cardiac index (CI), GEDI, systemic vascular resistance index (SVRI), extravascular lung water index (ELWI) measured by PiCCO, and daily neurological outcome of patients and GCS values were recorded. ","[{'ForeName': 'Nihan', 'Initials': 'N', 'LastName': 'Yaman Mammadov', 'Affiliation': 'Department of Anesthesiology, University of Health Sciences, Van Training and Research Hospital, Van-Turkey.'}, {'ForeName': 'Achmet', 'Initials': 'A', 'LastName': 'Ali', 'Affiliation': 'Department of Anesthesiology, İstanbul University İstanbul Faculty of Medicine, İstanbul-Turkey.'}, {'ForeName': 'Orkhan', 'Initials': 'O', 'LastName': 'Mammadov', 'Affiliation': 'Department of Intensive Care Unit, Altunizade Acıbadem Hospital, İstanbul-Turkey.'}, {'ForeName': 'Ararso Kedir', 'Initials': 'AK', 'LastName': 'Jima', 'Affiliation': 'Department of Intensive Care Unit, Altunizade Acıbadem Hospital, İstanbul-Turkey.'}, {'ForeName': 'Günseli', 'Initials': 'G', 'LastName': 'Orhun', 'Affiliation': 'Department of Anesthesiology, İstanbul University İstanbul Faculty of Medicine, İstanbul-Turkey.'}, {'ForeName': 'Ibrahim Ozkan', 'Initials': 'IO', 'LastName': 'Akinci', 'Affiliation': 'Department of Intensive Care Unit, Taksim Acıbadem Hospital, İstanbul-Turkey.'}]",Ulusal travma ve acil cerrahi dergisi = Turkish journal of trauma & emergency surgery : TJTES,['10.14744/tjtes.2020.24412'] 2002,32589244,The effects of analgesic treatment and chest physiotherapy on the complications of the patients with rib fractures that arise from blunt chest trauma.,"BACKGROUND This prospective study aims to investigate the effect of chest physiotherapy and analgesic therapy on the possible complications of isolated rib fractures attributable to blunt thoracic trauma, such as hemothorax and pneumothorax. METHODS Patients who presented to Çanakkale Onsekiz Mart University School of Medicine Hospital's Emergency Department and Thoracic Surgery outpatient clinics within the first 24 hours of the post-traumatic period and did not have additional intrathoracic complications at presentation with blunt thoracic trauma and who were diagnosed with isolated rib fractures were enrolled in this prospective research study. The groups were designated as the patients who would receive analgesic treatment only (Group A) and the patients who would receive chest physiotherapy and analgesic treatment together (Group B). Patients who had first and second rib fractures or three or more rib fractures and who did not have additional organ injury were hospitalized in the Thoracic Surgery clinics; patients who had other organ trauma were hospitalized in related clinics. Patients were reassessed on their seventh and 30th post-traumatic days with physical examination and radiologic studies. RESULTS The mean age of the 114 patients were 56.3±16.4 (22-87). There were 37 (32.5%) women and 77 (67.5%) men. Each group included 57 patients. The most common form of trauma was the same-level falls (31.6%). The mean number of rib fractures of all participants was 2.6±0.7 (1-10); the median number was 1.5. Fifty-two (45.6%) patients were hospitalized. The mean length of stay was 4.0±1.1 days. At the end of their treatment and follow-up periods, pleural effusion was found in 28 patients (24.6%) out of 114 enrolled at the side of trauma. Group B had a higher number of patients with pleural effusion (43.9%) than group A (5.3%). We performed tube thoracostomy in four patients, all of which were in group B (p<0.05). CONCLUSION As a result of this study, chest physiotherapy maneuvers have increased the incidence of late hemothorax in patients with three or more isolated rib fractures. Also, minimal hemothoraces (<300 ml) may spontaneously regress, and no additional surgical treatment are required if the proper follow-up procedures are performed. It is advisable to hospitalize the blunt thoracic trauma patients who have three or more rib fractures and who are planned to undergo chest physiotherapy and or are prone to develop additional complications because of possible risks.",2020,"We performed tube thoracostomy in four patients, all of which were in group B (p<0.05). ","['Each group included 57 patients', 'blunt thoracic trauma patients who have three or more rib fractures', 'Patients who had first and second rib fractures or three or more rib fractures and who did not have additional organ injury were hospitalized in the Thoracic Surgery clinics; patients who had other organ trauma were hospitalized in related clinics', 'Fifty-two (45.6%) patients were hospitalized', '28 patients (24.6%) out of 114 enrolled at the side of trauma', 'patients with three or more isolated rib fractures', ""Patients who presented to Çanakkale Onsekiz Mart University School of Medicine Hospital's Emergency Department and Thoracic Surgery outpatient clinics within the first 24 hours of the post-traumatic period and did not have additional intrathoracic complications at presentation with blunt thoracic trauma and who were diagnosed with isolated rib fractures"", 'The mean age of the 114 patients were 56.3±16.4 (22-87', 'patients with rib fractures that arise from blunt chest trauma', 'There were 37 (32.5%) women and 77 (67.5%) men', 'Patients were reassessed on their seventh and 30th post-traumatic days with physical examination and radiologic studies']","['chest physiotherapy and analgesic therapy', 'chest physiotherapy and analgesic treatment together', 'analgesic treatment and chest physiotherapy']","['mean length of stay', 'incidence of late hemothorax', 'higher number of patients with pleural effusion', 'mean number of rib fractures']","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1997138', 'cui_str': 'Blunted'}, {'cui': 'C0729233', 'cui_str': 'Dissecting aortic aneurysm, thoracic'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0035522', 'cui_str': 'Fracture of rib'}, {'cui': 'C0920004', 'cui_str': 'Second rib fracture'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0039986', 'cui_str': 'Thoracic surgery'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C4319570', 'cui_str': '52'}, {'cui': 'C4708785', 'cui_str': '114'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0332663', 'cui_str': 'Traumatic'}, {'cui': 'C0595836', 'cui_str': 'Intrathoracic route'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0449450', 'cui_str': 'Presentation'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332285', 'cui_str': 'In'}, {'cui': 'C0039980', 'cui_str': 'Chest injury'}, {'cui': 'C4517710', 'cui_str': '32.5'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0199467', 'cui_str': 'Physiotherapy of chest'}, {'cui': 'C0412784', 'cui_str': 'Analgesic technique'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0019123', 'cui_str': 'Hemothorax'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032227', 'cui_str': 'Pleural effusion'}, {'cui': 'C0035522', 'cui_str': 'Fracture of rib'}]",114.0,0.0219527,"We performed tube thoracostomy in four patients, all of which were in group B (p<0.05). ","[{'ForeName': 'Timuçin', 'Initials': 'T', 'LastName': 'Alar', 'Affiliation': 'Department of Thoracic Surgery, Çanakkale Onsekiz Mart University Faculty of Medicine, Çanakkale-Turkey.'}, {'ForeName': 'İsmail Ertuğrul', 'Initials': 'İE', 'LastName': 'Gedik', 'Affiliation': 'Department of Thoracic Surgery, Erzurum Regional Education and Research Hospital, Erzurum, Turkey.'}, {'ForeName': 'Murat', 'Initials': 'M', 'LastName': 'Kara', 'Affiliation': 'Department of Thoracic Surgery, İstanbul University İstanbul Faculty of Medicine, İstanbul-Turkey.'}]",Ulusal travma ve acil cerrahi dergisi = Turkish journal of trauma & emergency surgery : TJTES,['10.14744/tjtes.2019.26356'] 2003,31811480,"Efficacy of oral administration of cystine and theanine in colorectal cancer patients undergoing capecitabine-based adjuvant chemotherapy after surgery: a multi-institutional, randomized, double-blinded, placebo-controlled, phase II trial (JORTC-CAM03).","PURPOSE Capecitabine-based adjuvant chemotherapy for colorectal cancer patients often causes adverse events (AEs), such as diarrhea, stomatitis, anorexia, and hand-foot syndrome (HFS). Cystine and theanine were reported to attenuate some chemotherapy-associated AEs, and hence are also expected to attenuate capecitabine-induced AEs. Therefore, we aimed to investigate the safety and efficacy of cystine/theanine treatment in colorectal cancer patients undergoing capecitabine-based adjuvant chemotherapy after surgery. METHODS A total of 100 colorectal cancer patients treated with capecitabine as an adjuvant chemotherapy after surgery were randomly allocated into the cystine/theanine group (n = 52) or the placebo group (n = 48). The primary endpoint was incidence rate of diarrhea of grade 1 or higher in accordance with the Common Terminology Criteria for AEs (CTCAE) v.4.0, Japanese Clinical Oncology Group (JCOG) version. The secondary endpoints included incidence rates of other AEs (CTCAE v.4.0-JCOG), as well as the incidence rate of HFS according to the HFS grading scale. RESULTS There were no significant differences in capecitabine-induced AEs between the two groups. However, the incidence rate of diarrhea of grade 1 or higher tended to be lower in the cystine/theanine group than the placebo group (18.4% vs. 28.9%, p = 0.169) as well as the incidence rate of HFS of grade 1 or higher (CTCAE v.4.0-JCOG or HFS grading scale) (67.4% vs. 77.8%, p = 0.185, 67.3% vs. 80.0%, p = 0.124, respectively). CONCLUSION This trial demonstrated that cystine/theanine treatment of colorectal cancer patients undergoing capecitabine-based adjuvant chemotherapy after surgery is safe and has the tendency to reduce the incidence rate of diarrhea or HFS. TRIAL REGISTRATION UMIN000024784.",2020,There were no significant differences in capecitabine-induced AEs between the two groups.,"['100 colorectal cancer patients treated with', 'colorectal cancer patients undergoing', 'as an adjuvant chemotherapy after surgery', 'colorectal cancer patients', 'colorectal cancer patients undergoing capecitabine-based adjuvant chemotherapy after surgery']","['Cystine and theanine', 'capecitabine-based adjuvant chemotherapy', 'cystine/theanine treatment', 'capecitabine', 'Capecitabine-based adjuvant chemotherapy', 'cystine and theanine', 'cystine/theanine', 'placebo']","['incidence rate of diarrhea of grade 1 or higher in accordance with the Common Terminology Criteria for AEs (CTCAE', 'incidence rate of diarrhea', 'safety and efficacy', 'incidence rates of other AEs (CTCAE v.4.0-JCOG), as well as the incidence rate of HFS according to the HFS grading scale', 'incidence rate of HFS of grade 1 or higher (CTCAE v.4.0-JCOG or HFS grading scale']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0010682', 'cui_str': 'Cystine'}, {'cui': 'C0076380', 'cui_str': 'theanine'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0475269', 'cui_str': 'G1 grade'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1516728', 'cui_str': 'National Cancer Institute common terminology criteria for adverse events'}, {'cui': 'C0205214', 'cui_str': 'Common'}, {'cui': 'C0028275', 'cui_str': 'Terminology'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C1274034', 'cui_str': 'Clinical oncology'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0549410', 'cui_str': 'Palmar-plantar erythrodysaesthesia syndrome'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",100.0,0.573596,There were no significant differences in capecitabine-induced AEs between the two groups.,"[{'ForeName': 'Reo', 'Initials': 'R', 'LastName': 'Hamaguchi', 'Affiliation': 'Department of Palliative Medicine, The Institute of Medical Science, The University of Tokyo, Tokyo, Japan. reo-h@nifty.com.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Tsuchiya', 'Affiliation': 'Department of Gastroenterological Surgery, Sendai City Medical Center, Sendai Open Hospital, Sendai, Miyagi, Japan.'}, {'ForeName': 'Go', 'Initials': 'G', 'LastName': 'Miyata', 'Affiliation': 'Department of Gastroenterological Surgery, Iwate Prefectural Central Hospital, Morioka, Iwate, Japan.'}, {'ForeName': 'Toshihiko', 'Initials': 'T', 'LastName': 'Sato', 'Affiliation': 'Department of Surgery, Yamagata Prefectural Central Hospital, Yamagata, Japan.'}, {'ForeName': 'Kenichi', 'Initials': 'K', 'LastName': 'Takahashi', 'Affiliation': 'Department of Colorectal Surgery, Tohoku Rosai Hospital, Sendai, Miyagi, Japan.'}, {'ForeName': 'Koh', 'Initials': 'K', 'LastName': 'Miura', 'Affiliation': 'Department of Surgery, Miyagi Cancer Center, Sendai, Miyagi, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Oshio', 'Affiliation': 'Department of Surgery, Sendai Medical Center, Sendai, Miyagi, Japan.'}, {'ForeName': 'Hisatsugu', 'Initials': 'H', 'LastName': 'Ohori', 'Affiliation': 'Department of Clinical Oncology, Ishinomaki Red Cross Hospital, Ishinomaki, Miyagi, Japan.'}, {'ForeName': 'Keisuke', 'Initials': 'K', 'LastName': 'Ariyoshi', 'Affiliation': 'JORTC Data Center, Tokyo, Japan.'}, {'ForeName': 'Shunsuke', 'Initials': 'S', 'LastName': 'Oyamada', 'Affiliation': 'JORTC Data Center, Tokyo, Japan.'}, {'ForeName': 'Satoru', 'Initials': 'S', 'LastName': 'Iwase', 'Affiliation': 'Department of Palliative Medicine, The Institute of Medical Science, The University of Tokyo, Tokyo, Japan.'}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-019-05205-1'] 2004,31823057,Benefits of using the Brief Pain Inventory in patients with cancer pain: an intervention study conducted in Swedish hospitals.,"PURPOSE The prevalence of cancer pain is too high. There is a need for improvement of pain management in cancer care. The aim of this study was to explore whether the use of the multidimensional pain assessment questionnaire Brief Pain Inventory (BPI) could improve pain relief in hospitalized patients with cancer. METHODS A controlled intervention study was performed at two hospitals in western Sweden, 264 patients were included, 132 formed a control group and 132 an intervention group. All participants completed the BPI and the Edmonton Symptom Assessment Scale (ESAS) at baseline. Only the researcher had access to questionnaires from the control group. The completed forms from the intervention group were presented to the patients' care team. A follow-up took place after 2-5 days when patients in both groups rated the scales a second time. RESULTS In the intervention group, significant differences in all measured items of the BPI were found at follow-up compared with baseline. Symptoms rated with the ESAS also decreased significantly, except shortness of breath. At follow-up, a significant increase in regular use of paracetamol, anti-neuropathic pain drugs and opioids was found, as well as elevated doses of fixed-schedule opioids. In the control group, differences between baseline and follow-up were significant regarding average pain and worst pain over the past 24 h. CONCLUSION Presenting the patient-reported BPI to the care team helped them to focus on patients' pain, identify pain mechanisms and adjust analgesics accordingly. A possible explanation for the results is changes in the medication prescribed.",2020,"In the control group, differences between baseline and follow-up were significant regarding average pain and worst pain over the past 24 h. CONCLUSION Presenting the patient-reported BPI to the care team helped them to focus on patients' pain, identify pain mechanisms and adjust analgesics accordingly.","['patients with cancer pain', 'two hospitals in western Sweden, 264 patients were included, 132 formed a control group and 132 an intervention group', 'hospitalized patients with cancer', 'Swedish hospitals']","['Brief Pain Inventory', 'multidimensional pain assessment questionnaire Brief Pain Inventory (BPI']","['regular use of paracetamol, anti-neuropathic pain drugs and opioids', 'pain relief', 'BPI', 'average pain and worst pain', 'except shortness of breath', 'BPI and the Edmonton Symptom Assessment Scale (ESAS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0596240', 'cui_str': 'Cancer pain'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0038996', 'cui_str': 'Swedish language'}]","[{'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0030198', 'cui_str': 'Pain assessment'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]","[{'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0027796', 'cui_str': 'Neuralgia'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C3494437', 'cui_str': 'Symptom Assessment'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",264.0,0.0362389,"In the control group, differences between baseline and follow-up were significant regarding average pain and worst pain over the past 24 h. CONCLUSION Presenting the patient-reported BPI to the care team helped them to focus on patients' pain, identify pain mechanisms and adjust analgesics accordingly.","[{'ForeName': 'Viveka', 'Initials': 'V', 'LastName': 'Andersson', 'Affiliation': 'The Sahlgrenska Academy, Institute of Health and Care Sciences, University of Gothenburg, Box 457, SE-405 30, Gothenburg, Sweden. viveka.andersson@regionhalland.se.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Bergman', 'Affiliation': 'Primary Health Care Unit, Department of Public Health and Community Medicine, Institute of Medicine, The Sahlgrenska Academy, University of Gothenburg, Box 457, SE-405 30, Gothenburg, Sweden.'}, {'ForeName': 'Ingela', 'Initials': 'I', 'LastName': 'Henoch', 'Affiliation': 'The Sahlgrenska Academy, Institute of Health and Care Sciences, University of Gothenburg, Box 457, SE-405 30, Gothenburg, Sweden.'}, {'ForeName': 'Hanna', 'Initials': 'H', 'LastName': 'Simonsson', 'Affiliation': 'Department of Surgery, Hallands Hospital Halmstad, Lasarettsvägen, 302 42, Halmstad, Sweden.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Ahlberg', 'Affiliation': 'The Sahlgrenska Academy, Institute of Health and Care Sciences, University of Gothenburg, Box 457, SE-405 30, Gothenburg, Sweden.'}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-019-05200-6'] 2005,32463786,Comparative Effectiveness of 2 Diabetes Prevention Lifestyle Programs in the Workplace: The City and County of San Francisco Diabetes Prevention Trial.,"INTRODUCTION Data on the comparative effectiveness of Diabetes Prevention Programs (DPPs) in the workplace are limited. METHODS Between September 2015 and July 2016, employees of the City and County of San Francisco who were at risk for type 2 diabetes (N = 158) were randomly assigned to one of 2 DPP-derived programs recognized by the Centers for Disease Control and Prevention: an in-person YMCA-DPP (n = 78) or an online virtual lifestyle management DPP (VLM-DPP) offered through Canary Health (n = 80). The primary outcome was change in body weight assessed at 6 and 12 months. Follow-up ended in August 2017. RESULTS Both the YMCA-DPP and VLM-DPP yielded a significant reduction in percentage body weight at 6 months. For the YMCA-DPP, mean percentage change at 6 months was -2.70% (95% confidence interval [CI], -3.91% to -1.48%) and at 12 months was -2.46% (95% CI, -4.24% to -0.68%). For the VLM-DPP, mean percentage change at 6 months was -2.41% (95% CI, -4.07% to -0.77%) and at 12 months was -1.59% (95% CI, -3.51% to 0.33%). The mean between-condition difference at 6 months was -0.25% (95% CI, -2.04% to 1.55%) and at 12 months was -0.84% (95% CI, -3.03% to 1.34%). No significant differences were observed between conditions. The YMCA-DPP had a slightly higher reduction in waist circumference than VLM-DDP at 6 months (mean between-condition difference -2.00 cm [95% CI, -4.24 to 0.25 cm]). Participant engagement, expressed as mean number of completed core program sessions, was significantly higher for the YMCA-DPP than the VLM-DPP. Participants of the YMCA-DPP completed an average of 10.2 sessions (95% CI, 9.0 to 11.4), and participants of the VLM-DPP completed an average of 5.9 sessions (95% CI, 4.7 to 7.1). The adjusted mean between-condition difference was 4.2 sessions (95% CI, 2.54 to 5.99). CONCLUSION Both the YMCA-DPP and VLM-DPP yielded weight loss at 6 months, which was maintained at 12 months in the YMCA-DPP. The workplace may be an effective setting to offer DPPs.",2020,The YMCA-DPP had a slightly higher reduction in waist circumference than VLM-DDP at 6 months,"['N = 158', 'Between September 2015 and July 2016, employees of the City and County of San Francisco who were at risk for type 2 diabetes']","['2 Diabetes Prevention Lifestyle Programs', 'Diabetes Prevention Programs (DPPs', 'DPP-derived programs recognized by the Centers for Disease Control and Prevention: an in-person YMCA-DPP (n = 78) or an online virtual lifestyle management DPP (VLM-DPP) offered through Canary Health']","['weight loss', 'change in body weight', 'waist circumference', 'percentage body weight']","[{'cui': 'C0599987', 'cui_str': 'Employee'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0036152', 'cui_str': 'San Francisco'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}]","[{'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0007670', 'cui_str': 'Centers for Disease Control and Prevention (U.S.)'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C0006824', 'cui_str': 'Genus Serinus'}, {'cui': 'C0018684', 'cui_str': 'Health'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0439165', 'cui_str': 'Percent'}]",158.0,0.0835716,The YMCA-DPP had a slightly higher reduction in waist circumference than VLM-DDP at 6 months,"[{'ForeName': 'Assiamira', 'Initials': 'A', 'LastName': 'Ferrara', 'Affiliation': 'Division of Research, Kaiser Permanente Northern California, 2000 Broadway, Oakland, CA 94612. Email: assiamira.ferrara@kp.org.'}, {'ForeName': 'Julia C', 'Initials': 'JC', 'LastName': 'McDonald', 'Affiliation': 'Division of Research, Kaiser Permanente Northern California, Oakland, California.'}, {'ForeName': 'Susan D', 'Initials': 'SD', 'LastName': 'Brown', 'Affiliation': 'Division of Research, Kaiser Permanente Northern California, Oakland, California.'}, {'ForeName': 'Janet G', 'Initials': 'JG', 'LastName': 'Alexander', 'Affiliation': 'Division of Research, Kaiser Permanente Northern California, Oakland, California.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Christian-Herman', 'Affiliation': 'Kaiser Foundation Health Plan, Oakland, California.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Fisher', 'Affiliation': 'San Francisco Health Service System, San Francisco, California.'}, {'ForeName': 'Charles P', 'Initials': 'CP', 'LastName': 'Quesenberry', 'Affiliation': 'Division of Research, Kaiser Permanente Northern California, Oakland, California.'}]",Preventing chronic disease,['10.5888/pcd17.190396'] 2006,32464019,Comparative Evaluation of Bone Formation between PRF and Blood Clot Alone as the Sole Sinus-Filling Material in Maxillary Sinus Augmentation with the Implant as a Tent Pole: A Randomized Split-Mouth Study.,"The lack of bone volume in the posterior maxillary region can be augmented with sinus elevation. Since the elevated sinus is a closed cavity, a blood clot that fills the sinus space itself can aid in bone formation. The aim of this study was to compare bone formation in the elevated maxillary sinus between platelet-rich fibrin (PRF) and blood clot alone as the sole sinus-filling material with the implant as a tent pole. The study was a randomized controlled trial with a split-mouth design involving seven patients. An implant was placed on one side only and blood was allowed to fill the elevated sinus cavity; on the other side, PRF plugs were inserted. The sinus window was covered by nonresorbable titanium-reinforced membrane. The results showed that there was no statistically significant difference between the two groups, but the PRF group showed increased bone gain in the mesial, buccal, and palatal regions, and increased average height and bucco-palatal width at the height of the old and new sinus floor. A greater increase in distal bone height was seen in the control group. It was concluded that PRF may be more effective as a sole sinus-filling material in the elevated sinus cavity with an implant as a tent pole.",2019,"The results showed that there was no statistically significant difference between the two groups, but the PRF group showed increased bone gain in the mesial, buccal, and palatal regions, and increased average height and bucco-palatal width at the height of the old and new sinus floor.","['seven patients', 'Maxillary Sinus Augmentation with the Implant as a Tent Pole']","['PRF and Blood Clot Alone', 'PRF', 'platelet-rich fibrin (PRF) and blood clot alone']","['bone gain in the mesial, buccal, and palatal regions, and increased average height and bucco-palatal width', 'distal bone height', 'bone formation']","[{'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024957', 'cui_str': 'Maxillary sinus structure'}, {'cui': 'C0332509', 'cui_str': 'Increased size'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0677506', 'cui_str': 'Tent'}, {'cui': 'C0337815', 'cui_str': 'Poles'}]","[{'cui': 'C4505052', 'cui_str': 'Leukocyte- and Platelet-Rich Fibrin'}, {'cui': 'C0087086', 'cui_str': 'Thrombus'}]","[{'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0442010', 'cui_str': 'Buccal'}, {'cui': 'C0700374', 'cui_str': 'Palatal'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0487742', 'cui_str': 'Width'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0029433', 'cui_str': 'Bone formation'}]",7.0,0.0173919,"The results showed that there was no statistically significant difference between the two groups, but the PRF group showed increased bone gain in the mesial, buccal, and palatal regions, and increased average height and bucco-palatal width at the height of the old and new sinus floor.","[{'ForeName': 'Gurumoorthy', 'Initials': 'G', 'LastName': 'Kaarthikeyan', 'Affiliation': 'Department of Periodontics, Saveetha Dental College, Saveetha University, Chennai-77.'}, {'ForeName': 'N D', 'Initials': 'ND', 'LastName': 'Jayakumar', 'Affiliation': 'Saveetha Dental College, Saveetha University, Chennai-77 India.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Sivakumar', 'Affiliation': 'Private Practitioner, Thirupur, India.'}]",Journal of long-term effects of medical implants,['10.1615/JLongTermEffMedImplants.2019031387'] 2007,32471973,The neuropeptide substance P regulates aldosterone secretion in human adrenals.,"Aldosterone, produced by the adrenals and under the control of plasma angiotensin and potassium levels, regulates hydromineral homeostasis and blood pressure. Here we report that the neuropeptide substance P (SP) released by intraadrenal nerve fibres, stimulates aldosterone secretion via binding to neurokinin type 1 receptors (NK1R) expressed by aldosterone-producing adrenocortical cells. The action of SP is mediated by the extracellular signal-regulated kinase pathway and involves upregulation of steroidogenic enzymes. We also conducted a prospective proof-of-concept, double blind, placebo-controlled clinical trial aimed to investigate the impact of the NK1R antagonist aprepitant on aldosterone secretion in healthy male volunteers (EudraCT: 2008-003367-40, ClinicalTrial.gov: NCT00977223). Participants received during two 7-day treatment periods aprepitant (125 mg on the 1 st day and 80 mg during the following days) or placebo in a random order at a 2-week interval. The primary endpoint was plasma aldosterone levels during posture test. Secondary endpoints included basal aldosterone alterations, plasma aldosterone variation during metoclopramide and hypoglycaemia tests, and basal and stimulated alterations of renin, cortisol and ACTH during the three different stimulatory tests. The safety of the treatment was assessed on the basis of serum transaminase measurements on days 4 and 7. All pre-specified endpoints were achieved. Aprepitant decreases aldosterone production by around 30% but does not influence the aldosterone response to upright posture. These results indicate that the autonomic nervous system exerts a direct stimulatory tone on mineralocorticoid synthesis through SP, and thus plays a role in the maintenance of hydromineral homeostasis. This regulatory mechanism may be involved in aldosterone excess syndromes.",2020,Aprepitant decreases aldosterone production by around 30% but does not influence the aldosterone response to upright posture.,"['healthy male volunteers (EudraCT', 'human adrenals']","['NK1R antagonist aprepitant', 'Aldosterone', 'neuropeptide substance P (SP', 'placebo']","['plasma aldosterone levels', 'aldosterone secretion', 'aldosterone production', 'plasma angiotensin and potassium levels, regulates hydromineral homeostasis and blood pressure', 'basal aldosterone alterations, plasma aldosterone variation during metoclopramide and hypoglycaemia tests, and basal and stimulated alterations of renin, cortisol and ACTH']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0001625', 'cui_str': 'Adrenal structure'}]","[{'cui': 'C0038581', 'cui_str': 'Neurokinin alpha'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C4543207', 'cui_str': 'Receptor antagonist'}, {'cui': 'C1176306', 'cui_str': 'aprepitant'}, {'cui': 'C0002006', 'cui_str': 'Aldosterone'}, {'cui': 'C0027895', 'cui_str': 'Neuropeptide'}, {'cui': 'C0038585', 'cui_str': 'Substance P'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1272143', 'cui_str': 'Plasma aldosterone level'}, {'cui': 'C0002006', 'cui_str': 'Aldosterone'}, {'cui': 'C0036536', 'cui_str': 'secretion'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0003018', 'cui_str': 'Angiotensin'}, {'cui': 'C0202194', 'cui_str': 'Potassium measurement'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0857639', 'cui_str': 'Plasma aldosterone'}, {'cui': 'C0042333', 'cui_str': 'Genetic variation'}, {'cui': 'C0025853', 'cui_str': 'Metoclopramide'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0035094', 'cui_str': 'Renin'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0001655', 'cui_str': 'Corticotropin'}]",,0.0620632,Aprepitant decreases aldosterone production by around 30% but does not influence the aldosterone response to upright posture.,"[{'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Wils', 'Affiliation': 'Normandie Univ, UNIROUEN, INSERM, DC2N, 76000, Rouen, France.'}, {'ForeName': 'Céline', 'Initials': 'C', 'LastName': 'Duparc', 'Affiliation': 'Normandie Univ, UNIROUEN, INSERM, DC2N, 76000, Rouen, France.'}, {'ForeName': 'Anne-Françoise', 'Initials': 'AF', 'LastName': 'Cailleux', 'Affiliation': 'Rouen University Hospital, Department of Endocrinology, Diabetes and Metabolic Diseases, 76000, Rouen, France.'}, {'ForeName': 'Antoine-Guy', 'Initials': 'AG', 'LastName': 'Lopez', 'Affiliation': 'Normandie Univ, UNIROUEN, INSERM, DC2N, 76000, Rouen, France.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Guiheneuf', 'Affiliation': 'Rouen University Hospital, Department of Endocrinology, Diabetes and Metabolic Diseases, 76000, Rouen, France.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Boutelet', 'Affiliation': 'Normandie Univ, UNIROUEN, INSERM, DC2N, 76000, Rouen, France.'}, {'ForeName': 'Hadrien-Gaël', 'Initials': 'HG', 'LastName': 'Boyer', 'Affiliation': 'Normandie Univ, UNIROUEN, INSERM, DC2N, 76000, Rouen, France.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Dubessy', 'Affiliation': 'Normandie Univ, UNIROUEN, INSERM, DC2N, 76000, Rouen, France.'}, {'ForeName': 'Saloua', 'Initials': 'S', 'LastName': 'Cherifi', 'Affiliation': 'Normandie Univ, UNIROUEN, INSERM, DC2N, 76000, Rouen, France.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Cauliez', 'Affiliation': 'Rouen University Hospital, Department of Biochemistry, 76000, Rouen, France.'}, {'ForeName': 'Françoise', 'Initials': 'F', 'LastName': 'Gobet', 'Affiliation': 'Rouen University Hospital, Department of Pathology, 76000, Rouen, France.'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Defortescu', 'Affiliation': 'Rouen University Hospital, Department of Urology, 76000, Rouen, France.'}, {'ForeName': 'Jean-François', 'Initials': 'JF', 'LastName': 'Ménard', 'Affiliation': 'Rouen University Hospital, Department of Biostatistics, 76000, Rouen, France.'}, {'ForeName': 'Estelle', 'Initials': 'E', 'LastName': 'Louiset', 'Affiliation': 'Normandie Univ, UNIROUEN, INSERM, DC2N, 76000, Rouen, France.'}, {'ForeName': 'Hervé', 'Initials': 'H', 'LastName': 'Lefebvre', 'Affiliation': 'Normandie Univ, UNIROUEN, INSERM, DC2N, 76000, Rouen, France. herve.lefebvre@chu-rouen.fr.'}]",Nature communications,['10.1038/s41467-020-16470-8'] 2008,32470975,Vitamin B-12 Supplementation during Pregnancy and Early Lactation Does Not Affect Neurophysiologic Outcomes in Children Aged 6 Years.,"BACKGROUND Deficiency of vitamin B-12 is common in pregnant Indian women. Assessment of neurophysiological measures using event-related potentials (ERPs) may yield additional information on the effects of maternal B-12 supplementation on child brain function. OBJECTIVES The objective of the study was to evaluate the effects of vitamin B-12 supplementation (50 μg daily orally) during pregnancy on the childhood ERP measures of positive waveform ∼300 ms after stimulus (P300) and mismatch negativity. METHODS This study was a follow-up of children born to pregnant women who received oral vitamin B-12 supplements (n = 62) compared with children of pregnant women who received placebo (n = 70) from a randomized controlled trial. The mean ± SD child age was 72 ± 1 mo. We used the Enobio system to assess the ERP measures P300 and mismatch negativity. RESULTS There were no significant differences in the primary outcomes, amplitudes, and latencies of the P300 results and the mismatch negativity between children in the supplementation and placebo groups. We combined the intervention and placebo groups for secondary analyses. On multiple variable regression analysis after adjusting for treatment group, intrauterine growth restriction, and home environment, P300 amplitude in children was significantly higher in the lowest tertile of third-trimester maternal methylmalonic acid (MMA) concentrations (β = 3034.04; 95% CI: 923.24, 5144.83) compared with the highest MMA tertile (β = 1612.12; 95% CI: -258.86, 3483.10, P = 0.005). CONCLUSIONS While no significant effects of maternal vitamin B-12 supplementation on children's ERP measures were seen at 72 mo, elevated maternal MMA concentrations in the third trimester were negatively associated with P300 amplitude in children. It may be worthwhile to study the impact of maternal and infant vitamin B-12 supplementation on childhood brain structure and function in longer and larger trials. The parent trial was registered at clinicaltrials.gov as NCT00641862.",2020,"There were no significant differences in the primary outcomes, amplitudes, and latencies of the P300 results and the mismatch negativity between children in the supplementation and placebo groups.","['children born to pregnant women who received', 'n\xa0=\xa062) compared with children of pregnant women who received', 'during Pregnancy and Early Lactation', 'Children', 'Aged 6 Years', 'pregnant Indian women']","['event-related potentials (ERPs', 'vitamin B-12 supplementation', 'oral vitamin B-12 supplements', 'maternal vitamin B-12 supplementation', 'Vitamin B-12 Supplementation', 'placebo']","['childhood ERP measures of positive waveform ∼300\xa0ms after stimulus (P300) and mismatch negativity', 'amplitudes, and latencies of the P300 results and the mismatch negativity', ""children's ERP measures"", 'ERP measures P300 and mismatch negativity', 'maternal MMA concentrations', 'Neurophysiologic Outcomes']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0002460', 'cui_str': 'American Indian race'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0282171', 'cui_str': 'Event-related potentials'}, {'cui': 'C0042845', 'cui_str': 'Vitamin B 12'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0231335', 'cui_str': 'Childhood'}, {'cui': 'C0015214', 'cui_str': 'Evoked potential'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0450448', 'cui_str': 'Waveforms'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C0242465', 'cui_str': 'Response Latency'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0025787', 'cui_str': 'Methyl malonic acid'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.385632,"There were no significant differences in the primary outcomes, amplitudes, and latencies of the P300 results and the mismatch negativity between children in the supplementation and placebo groups.","[{'ForeName': 'Krishnamachari', 'Initials': 'K', 'LastName': 'Srinivasan', 'Affiliation': ""Division of Mental Health and Neurosciences, St. John's Research Institute, Bengaluru, Karnataka, India.""}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Thomas', 'Affiliation': ""Division of Mental Health and Neurosciences, St. John's Research Institute, Bengaluru, Karnataka, India.""}, {'ForeName': 'Shilpa', 'Initials': 'S', 'LastName': 'Anand', 'Affiliation': ""Division of Mental Health and Neurosciences, St. John's Research Institute, Bengaluru, Karnataka, India.""}, {'ForeName': 'Mahesh', 'Initials': 'M', 'LastName': 'Jayachandra', 'Affiliation': ""Division of Mental Health and Neurosciences, St. John's Research Institute, Bengaluru, Karnataka, India.""}, {'ForeName': 'Tinku', 'Initials': 'T', 'LastName': 'Thomas', 'Affiliation': ""Department of Biostatistics, St. John's Medical College, Bengaluru, Karnataka, India.""}, {'ForeName': 'Tor Arne', 'Initials': 'TA', 'LastName': 'Strand', 'Affiliation': 'Innlandet Hosptial Trust, Lillehammer, Norway.'}, {'ForeName': 'Anura V', 'Initials': 'AV', 'LastName': 'Kurpad', 'Affiliation': ""Division of Nutrition, St. John's Research Institute, Bengaluru, Karnataka, India.""}, {'ForeName': 'Christopher P', 'Initials': 'CP', 'LastName': 'Duggan', 'Affiliation': 'Department of Nutrition, Harvard TH Chan School of Public Health, Boston, MA, USA.'}]",The Journal of nutrition,['10.1093/jn/nxaa123'] 2009,32473216,"High-School Students Can Stop the Bleed: A Randomized, Controlled Educational Trial.","OBJECTIVE To determine high-school students' ability to learn hemorrhage control skills and knowledge via 3 educational modalities. BACKGROUND Trauma is the leading cause of death for young Americans, and there are calls to teach children about hemorrhage control. However, little is known about adolescents' ability to perform hemorrhage control, and the ideal way(s) to teach them. METHODS This randomized controlled trial enrolled high-school students from 39 states at a 2019 national conference. After answering questions about their willingness to use tourniquets, participants received hemorrhage control education in 1 of 3 formats: instructor-led, web-only, or blended (combining web and instructor-led). Participants were then assessed on their ability to apply a tourniquet and to identify wounds that require a tourniquet. Finally, they completed an attitude questionnaire. RESULTS Two hundred and four (82%) of 248 participants applied a tourniquet correctly: 72 (88%) instructor-led, 50 (61%) web-only, and 79 (94%) blended. The instructor-led and blended arms were superior to the web-only arm (P < .001). Nearly all participants passed an assessment requiring them to identify wounds warranting a tourniquet (99% instructor-led and blended, and 98% web-only). All modalities improved participants' self-reported willingness and comfort in using tourniquets (P < .001). CONCLUSIONS This is the first study to demonstrate that high-school students can learn hemorrhage control via multiple methods. Blended and instructor-led education led to highly successful skill performance. Students learned to identify wounds requiring tourniquets and showed an improved willingness to aid from all modalities. These findings should encourage educators to offer multiple educational modalities.",2020,Participants were then assessed on their ability to apply a tourniquet and to identify wounds that require a tourniquet.,"['High-School Students Can Stop the Bleed', 'enrolled high-school students from 39 states at a 2019 national conference', 'high school students', 'young Americans']",[],[],"[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0450446', 'cui_str': 'Stops'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0086047', 'cui_str': 'Conferences'}, {'cui': 'C0332239', 'cui_str': 'Young'}]",[],[],,0.114711,Participants were then assessed on their ability to apply a tourniquet and to identify wounds that require a tourniquet.,"[{'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Goolsby', 'Affiliation': 'Department of Military and Emergency Medicine, Uniformed Services University of the Health Sciences (C Goolsby), Bethesda, Md; National Center for Disaster Medicine and Public Health (C Goolsby, LE Rojas, and RH Rodzik), Rockville, Md. Electronic address: craig.goolsby@usuhs.edu.'}, {'ForeName': 'Luis E', 'Initials': 'LE', 'LastName': 'Rojas', 'Affiliation': 'National Center for Disaster Medicine and Public Health (C Goolsby, LE Rojas, and RH Rodzik), Rockville, Md; The Henry M. Jackson Foundation for the Advancement of Military Medicine (LE Rojas and RH Rodzik), Bethesda, Md.'}, {'ForeName': 'Raphaelle H', 'Initials': 'RH', 'LastName': 'Rodzik', 'Affiliation': 'National Center for Disaster Medicine and Public Health (C Goolsby, LE Rojas, and RH Rodzik), Rockville, Md; The Henry M. Jackson Foundation for the Advancement of Military Medicine (LE Rojas and RH Rodzik), Bethesda, Md.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Gausche-Hill', 'Affiliation': 'Los Angeles County Emergency Medical Services Agency (M Gausche-Hill), Los Angeles, Calif; Departments of Emergency Medicine and Pediatrics, David Geffen School of Medicine at the University of California (M Gausche-Hill), Los Angeles, Calif; Departments of Emergency Medicine and Pediatrics, Harbor-UCLA Medical Center (M Gausche-Hill), Torrance, Calif.'}, {'ForeName': 'Matthew D', 'Initials': 'MD', 'LastName': 'Neal', 'Affiliation': 'Departments of Surgery, Critical Care Medicine, and the Clinical and Translational Science Institute (CTSI), University of Pittsburgh (MD Neal), Pittsburgh, Pa; University of Pittsburgh Medical Center (MD Neal), Pittsburgh, Pa.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Levy', 'Affiliation': 'Department of Emergency Medicine, Johns Hopkins University School of Medicine (MJ Levy), Baltimore, Md; Howard County Department of Fire and Rescue Services (MJ Levy), Columbia, Md.'}]",Academic pediatrics,['10.1016/j.acap.2020.05.012'] 2010,32473275,Exploring the Effects of an Acute Dose of Antipsychotic Medication on Motivation-mediated BOLD Activity Using fMRI and a Perceptual Decision-making Task.,"The left inferior frontal gyrus and the bilateral ventral striatum are thought to be involved in motivation-mediated decision-making. Antipsychotics may influence this relationship, and atypical antipsychotics improve secondary negative symptoms in schizophrenia, such as loss of motivation, although the acute effects of pharmacological medication on motivation are not fully understood. In this single-blinded, randomized controlled trial, 49 healthy volunteers were randomized into three groups to receive a single dose of haloperidol, aripiprazole or placebo. Between 4.0 and 5.6 h later, participant's brain blood-oxygen-level dependent (BOLD) activity was recorded using functional magnetic resonance imaging (fMRI) while completing a perceptual decision-making fMRI task consisting of one neutral and one motivated condition. Response bias, reflecting the participant's willingness to say that the target stimulus is present, was calculated using signal detection theory. Concurrent with widespread changes in BOLD signal in the motivated vs. neutral condition, a less conservative, mathematically optimal response bias was observed in the motivated condition across the whole sample. Within-group differences in BOLD signal in the left inferior frontal gyrus and bilateral ventral striatum were observed between conditions in the aripiprazole and haloperidol groups, but not in the placebo group. No robust between-group differences in brain activity in the left inferior frontal gyrus or the bilateral ventral striatum were found. Overall, we found no robust evidence for an effect of either aripiprazole or haloperidol on motivationally mediated behavior. An interesting pattern of correlations possibly related to pharmacologically induced alterations in the dopamine system was observed, although findings remain inconclusive and must be replicated in larger samples.",2020,"Overall, we found no robust evidence for an effect of either aripiprazole or haloperidol on motivationally mediated behavior.",['49 healthy volunteers'],"['haloperidol, aripiprazole or placebo', 'haloperidol', 'Antipsychotics', 'aripiprazole', 'antipsychotic medication', 'placebo']","['BOLD signal', 'brain blood-oxygen-level dependent (BOLD) activity', 'brain activity', 'bilateral ventral striatum']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0018546', 'cui_str': 'Haloperidol'}, {'cui': 'C0299792', 'cui_str': 'aripiprazole'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0040615', 'cui_str': 'Antipsychotic agent'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0443158', 'cui_str': 'Brain activity'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0750950', 'cui_str': 'Ventral Striatum'}]",49.0,0.0560753,"Overall, we found no robust evidence for an effect of either aripiprazole or haloperidol on motivationally mediated behavior.","[{'ForeName': 'Carl', 'Initials': 'C', 'LastName': 'Delfin', 'Affiliation': 'NORMENT, KG Jebsen Centre for Psychosis Research, Division of Mental Health and Addiction, Oslo University Hospital, Norway; Centre for Ethics, Law and Mental Health, Institute of Neuroscience and Physiology, The Sahlgrenska Academy, University of Gothenburg, Sweden; Research Department, Regional Forensic Psychiatric Clinic Växjö, Sweden. Electronic address: carl.delfin@gu.se.'}, {'ForeName': 'Greg E', 'Initials': 'GE', 'LastName': 'Reckless', 'Affiliation': 'NORMENT, KG Jebsen Centre for Psychosis Research, Division of Mental Health and Addiction, Oslo University Hospital, Norway; Institute of Clinical Medicine, University of Oslo, Norway.'}, {'ForeName': 'Ingeborg', 'Initials': 'I', 'LastName': 'Bolstad', 'Affiliation': 'NORMENT, KG Jebsen Centre for Psychosis Research, Division of Mental Health and Addiction, Oslo University Hospital, Norway; Institute of Clinical Medicine, University of Oslo, Norway.'}, {'ForeName': 'Inge', 'Initials': 'I', 'LastName': 'Groote', 'Affiliation': 'Computational Radiology & Artificial Intelligence, Division of Radiology and Nuclear Medicine, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Ole A', 'Initials': 'OA', 'LastName': 'Andreassen', 'Affiliation': 'NORMENT, KG Jebsen Centre for Psychosis Research, Division of Mental Health and Addiction, Oslo University Hospital, Norway; Institute of Clinical Medicine, University of Oslo, Norway.'}, {'ForeName': 'Jimmy', 'Initials': 'J', 'LastName': 'Jensen', 'Affiliation': 'NORMENT, KG Jebsen Centre for Psychosis Research, Division of Mental Health and Addiction, Oslo University Hospital, Norway; Centre for Psychology, Kristianstad University, Kristianstad, Sweden.'}]",Neuroscience,['10.1016/j.neuroscience.2020.05.035'] 2011,32473765,Outcomes of orthodontic treatment performed by individual orthodontists vs 2 orthodontists collaborating on treatment.,"INTRODUCTION One factor that can affect treatment outcomes is the treatment provider, and this factor has not been extensively studied. This research aimed to evaluate orthodontic treatment quality, length, and efficiency when 2 orthodontists collaborated on treatment, compared with the treatment provided solely by either orthodontist. METHODS A total of 150 consecutively treated subjects were divided into 3 equal groups based on the treating clinician. Patients in group A were treated by orthodontist A, group B by orthodontist B, and group C by both orthodontists in collaboration. The Peer Assessment Rating (PAR), Index of Complexity, Outcome, and Need (ICON), American Board of Orthodontics-Discrepancy Index, and American Board of Orthodontics-Cast and Radiographic Evaluation were used to assess the pretreatment and posttreatment status. Patient age, gender, type of malocclusion, extraction treatment, orthognathic surgery, treatment length, number of visits, and treatment efficiency index were assessed. RESULTS Posttreatment PAR and ICON indices showed excellent results in all 3 groups. American Board of Orthodontics-Cast and Radiographic Evaluation was significantly higher in group C (25.3 points) than in group A (21.5 points) or group B (22.0 points) (P = 0.014). Patients in group A had significantly shorter treatment time (23 months) than those in either group B or C (26 months) (P = 0.011). Patients in group C required more appointments (27 visits) than those in either group A or B (23 and 25 visits, respectively). The treatment efficiency index showed no statistically significant difference among the 3 groups. CONCLUSIONS There was no difference in treatment quality among the 3 groups, as assessed by the PAR index and ICON. Jointly treated cases required 2 to 4 more visits and had higher American Board of Orthodontics-Cast and Radiograph Evaluation scores than those treated by either orthodontist. Complex cases required 6 to 7 more months when they were treated collaboratively.",2020,Jointly treated cases required 2 to 4 more visits and had higher American Board of Orthodontics-Cast and Radiograph Evaluation scores than those treated by either orthodontist.,['A total of 150 consecutively treated subjects'],[],"['shorter treatment time', 'Peer Assessment Rating (PAR), Index of Complexity, Outcome, and Need (ICON), American Board of Orthodontics-Discrepancy Index, and American Board of Orthodontics-Cast and Radiographic Evaluation', 'PAR index and ICON', 'treatment quality', 'higher American Board of Orthodontics-Cast and Radiograph Evaluation scores']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}]",[],"[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0429164', 'cui_str': 'Peer assessment rating (orthodontic index)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0332276', 'cui_str': 'Orthodontic'}, {'cui': 'C1290905', 'cui_str': 'Discrepancy'}, {'cui': 'C0179686', 'cui_str': 'Cast'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1306645', 'cui_str': 'Plain radiography'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",150.0,0.0151119,Jointly treated cases required 2 to 4 more visits and had higher American Board of Orthodontics-Cast and Radiograph Evaluation scores than those treated by either orthodontist.,"[{'ForeName': 'Suliman A', 'Initials': 'SA', 'LastName': 'Alsaeed', 'Affiliation': 'Faculty of Dentistry, Division of Orthodontics, University of British Columbia, Vancouver, British Columbia, Canada; College of Dentistry, King Saud Bin Abdulaziz University for Health Sciences, Riyadh, Saudi Arabia. Electronic address: alsaeeds@mail.ubc.ca.'}, {'ForeName': 'David B', 'Initials': 'DB', 'LastName': 'Kennedy', 'Affiliation': 'Faculty of Dentistry, Division of Orthodontics, University of British Columbia, Vancouver, British Columbia, Canada; Private Practice, Vancouver and Richmond, British Columbia, Canada.'}, {'ForeName': 'Jolanta', 'Initials': 'J', 'LastName': 'Aleksejuniene', 'Affiliation': 'Faculty of Dentistry, Division of Orthodontics, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Edwin H', 'Initials': 'EH', 'LastName': 'Yen', 'Affiliation': 'Faculty of Dentistry, Division of Orthodontics, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Benjamin T', 'Initials': 'BT', 'LastName': 'Pliska', 'Affiliation': 'Faculty of Dentistry, Division of Orthodontics, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Donal C', 'Initials': 'DC', 'LastName': 'Flanagan', 'Affiliation': 'Private Practice, Vancouver and Delta, British Columbia, Canada.'}]","American journal of orthodontics and dentofacial orthopedics : official publication of the American Association of Orthodontists, its constituent societies, and the American Board of Orthodontics",['10.1016/j.ajodo.2019.07.015'] 2012,32474302,Lower levels of high-density lipoprotein cholesterol are associated with increased cardiovascular events in patients with acute coronary syndrome.,"BACKGROUND AND AIMS This study aimed to elucidate whether high-density lipoprotein cholesterol (HDL-C) at 3-month follow-up for patients receiving contemporary lipid-lowering therapy after acute coronary syndrome (ACS) could predict cardiac events. METHODS The HIJ-PROPER study was a multicenter, prospective, randomized trial comparing intensive lipid-lowering therapy (pitavastatin + ezetimibe) and conventional lipid-lowering therapy (pitavastatin monotherapy) after ACS. The entire cohort was divided into three groups according to tertiles of HDL-C levels at 3-month follow-up (Group 1, HDL-C ≤43 mg/dL; Group 2, HDL-C >43, <53.6 mg/dL; Group 3; HDL-C ≥53.6 mg/dL). Baseline characteristics and incidence of the primary endpoint (a composite of all-cause death, non-fatal myocardial infarction, non-fatal stroke, unstable angina pectoris, or ischemia-driven revascularization) were compared among the three groups. RESULTS The primary endpoint event occurred in 34.8%, 30.1%, and 24.6% of patients in Groups 1, 2, and 3, respectively, and its incidence was significantly higher in Group 1 than in Group 3 (hazard ratio [HR], 1.5; 95% confidence interval [CI], 1.19-1.9; p = 0.001). Irrespective of the treatment regimen, Group 1 had significantly higher rates of the primary endpoint than Group 3 (pitavastatin + ezetimibe therapy: HR, 1.6; 95% CI, 1.12-2.22; p = 0.01 and pitavastatin monotherapy: HR, 1.4; 95% CI, 1.05-1.98; p = 0.02). These trends remained even after adjustment for baseline characteristics and lipid profiles. Multivariate analysis revealed that lower body mass index, prevalence of diabetes mellitus, higher levels of high-sensitivity C reactive protein at baseline, and lower levels of HDL-C at 3-month follow-up were independent predictors of the incidence of primary endpoint. CONCLUSIONS Lower levels of HDL-C at 3-month follow-up are independently associated with higher incidence of cardiovascular events in ACS patients receiving contemporary lipid-lowering therapy.",2020,"Irrespective of the treatment regimen, Group 1 had significantly higher rates of the primary endpoint than Group 3 (pitavastatin + ezetimibe therapy: HR, 1.6; 95% CI, 1.12-2.22; p = 0.01 and pitavastatin monotherapy: HR, 1.4; 95% CI, 1.05-1.98; p = 0.02).","['patients with acute coronary syndrome', 'ACS patients receiving contemporary lipid-lowering therapy', 'patients receiving contemporary lipid-lowering therapy after acute coronary syndrome (ACS']","['intensive lipid-lowering therapy (pitavastatin\xa0+\xa0ezetimibe) and conventional lipid-lowering therapy (pitavastatin monotherapy', 'high-density lipoprotein cholesterol (HDL-C']","['Baseline characteristics and incidence of the primary endpoint (a composite of all-cause death, non-fatal myocardial infarction, non-fatal stroke, unstable angina pectoris, or ischemia-driven revascularization', 'cardiovascular events', 'lower body mass index, prevalence of diabetes mellitus, higher levels of high-sensitivity C reactive protein at baseline, and lower levels of HDL-C']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0948089', 'cui_str': 'Acute coronary syndrome'}, {'cui': 'C0585943', 'cui_str': 'Lipid-lowering therapy'}]","[{'cui': 'C0585943', 'cui_str': 'Lipid-lowering therapy'}, {'cui': 'C1101838', 'cui_str': 'pitavastatin'}, {'cui': 'C1142985', 'cui_str': 'ezetimibe'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0023822', 'cui_str': 'HDL cholesterol'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0002965', 'cui_str': 'Impending infarction'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0231255', 'cui_str': 'Decreased body mass index'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0023822', 'cui_str': 'HDL cholesterol'}]",,0.0661322,"Irrespective of the treatment regimen, Group 1 had significantly higher rates of the primary endpoint than Group 3 (pitavastatin + ezetimibe therapy: HR, 1.6; 95% CI, 1.12-2.22; p = 0.01 and pitavastatin monotherapy: HR, 1.4; 95% CI, 1.05-1.98; p = 0.02).","[{'ForeName': 'Mayui', 'Initials': 'M', 'LastName': 'Nakazawa', 'Affiliation': ""Department of Cardiology, The Heart Institute of Japan, Tokyo Women's Medical University, 8-1 Kawada-cho, Shinjuku-ku, Tokyo, 162-8666, Japan.""}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Arashi', 'Affiliation': ""Department of Cardiology, The Heart Institute of Japan, Tokyo Women's Medical University, 8-1 Kawada-cho, Shinjuku-ku, Tokyo, 162-8666, Japan. Electronic address: arashi.hiroyuki@twmu.ac.jp.""}, {'ForeName': 'Junichi', 'Initials': 'J', 'LastName': 'Yamaguchi', 'Affiliation': ""Department of Cardiology, The Heart Institute of Japan, Tokyo Women's Medical University, 8-1 Kawada-cho, Shinjuku-ku, Tokyo, 162-8666, Japan.""}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Ogawa', 'Affiliation': ""Department of Cardiology, The Heart Institute of Japan, Tokyo Women's Medical University, 8-1 Kawada-cho, Shinjuku-ku, Tokyo, 162-8666, Japan.""}, {'ForeName': 'Nobuhisa', 'Initials': 'N', 'LastName': 'Hagiwara', 'Affiliation': ""Department of Cardiology, The Heart Institute of Japan, Tokyo Women's Medical University, 8-1 Kawada-cho, Shinjuku-ku, Tokyo, 162-8666, Japan.""}]",Atherosclerosis,['10.1016/j.atherosclerosis.2020.05.005'] 2013,32475705,The risk of developing disordered eating following a family-based program among children with overweight and obesity and their siblings: Retrospective and prospective analyses.,"BACKGROUND Studies have raised the concern that dieting and weight-loss programs may be a potential risk factor for developing eating disorders, and may have a potential to affect siblings as well. This study assessed the long-term risk of developing disordered eating among children with overweight and obesity and their siblings as well as the change in the obesogenic environment following a family-based intervention program. METHODS In a 30-month retrospective follow-up study (n=18 families in intervention group, n=26 families in control group, total of 81 children and siblings) and a 14-month prospective follow-up study (n=42 families, 78 children and siblings), families with one or more children with overweight or obesity ages 8-14 years participated in a multidisciplinary parent-child program called ""Maccabi Active"". Children's version of the eating-attitude-test (ChEAT) questionnaire, family eating-and-activity-habits questionnaire (FEAHQ) and BMI z-score were measured. RESULTS in the retrospective study, no difference between groups with respect to ChEAT scores in children and siblings was found. In the prospective study, the FEAHQ score significantly decreased after completion of the program (ΔFEAHQ=-16.2±4.9, p=0.001) and continued to decrease in the 8-month follow-up (ΔFEAHQ=-23.2±5.7, p=0.001). BMI z-scores decreased after 6 months (ΔBMI z-score=-0.3±0.1, p=0.014), and did not increase in the 8-month follow-up. CONCLUSIONS Our findings suggest no exacerbation in disordered eating behaviors among children with overweight or obesity or their siblings, thus alleviating concerns surrounding the development of disordered eating after participating in a family-based intervention. Moreover, improvement in obesogenic environment suggests potential benefits to the entire family.",2020,"BMI z-scores decreased after 6 months (ΔBMI z-score=-0.3±0.1, p=0.014), and did not increase in the 8-month follow-up. ","['n=18 families in intervention group, n=26 families in control group, total of 81 children and siblings) and a 14-month prospective follow-up study (n=42 families, 78 children and siblings), families with one or more children with overweight or obesity ages 8-14 years participated in a', 'children with overweight or obesity or their siblings', 'children with overweight and obesity and their siblings']","['multidisciplinary parent-child program called ""Maccabi Active']","['FEAHQ score', 'BMI z-scores', ""Children's version of the eating-attitude-test (ChEAT) questionnaire, family eating-and-activity-habits questionnaire (FEAHQ) and BMI z-score"", 'disordered eating behaviors']","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0037047', 'cui_str': 'Sibling'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C0016441', 'cui_str': 'Followup Studies'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0242479', 'cui_str': 'Interdisciplinary Studies'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0205177', 'cui_str': 'Active'}]","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0018464', 'cui_str': 'Habits'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0451136', 'cui_str': 'Eating attitudes test'}, {'cui': 'C0855228', 'cui_str': 'Eating disorder symptom'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",81.0,0.0161907,"BMI z-scores decreased after 6 months (ΔBMI z-score=-0.3±0.1, p=0.014), and did not increase in the 8-month follow-up. ","[{'ForeName': 'Batya', 'Initials': 'B', 'LastName': 'Shaharabany', 'Affiliation': 'Department of Nutritional Sciences, Tel-Hai College, Upper Galilee, Israel; Maccabi Health Care Services, Northern District, Haifa, Israel. Electronic address: batya496@gmail.com.'}, {'ForeName': 'Sigal', 'Initials': 'S', 'LastName': 'Tepper', 'Affiliation': 'Department of Nutritional Sciences, Tel-Hai College, Upper Galilee, Israel. Electronic address: sigalt@bgu.ac.il.'}, {'ForeName': 'Suzana', 'Initials': 'S', 'LastName': 'Berman', 'Affiliation': 'Maccabi Health Care Services, Northern District, Haifa, Israel. Electronic address: Berman_s@mac.org.il.'}, {'ForeName': 'Moria', 'Initials': 'M', 'LastName': 'Golan', 'Affiliation': 'Department of Nutritional Sciences, Tel-Hai College, Upper Galilee, Israel. Electronic address: moria.golan@mail.huji.ac.il.'}]",Obesity research & clinical practice,['10.1016/j.orcp.2020.04.007'] 2014,32476455,A multicomponent intervention to decrease sedentary time during hospitalization: a quasi-experimental pilot study.,"OBJECTIVE The aim of this study was to evaluate the feasibility and preliminary effects of a multicomponent intervention to decrease sedentary time during and shortly after hospitalization. DESIGN This is a quasi-experimental pilot study comparing outcomes in patients admitted before and after the implementation of the intervention. SETTING The study was conducted in a university hospital. SUBJECTS Participants were adult patients undergoing elective organ transplantation or vascular surgery. INTERVENTIONS In the control phase, patients received usual care, whereas in the intervention phase, patients also received a multicomponent intervention to decrease sedentary time. The intervention comprised eight elements: paper and digital information, an exercise movie, an activity planner, a pedometer and Fitbit Flex™, a personal activity coach and an individualized digital training program. MEASURES Measures of feasiblity were the self-reported use of the intervention components (yes/no) and satisfaction (low-high = 0-10). Main outcome measure was the median % of sedentary time measured by an accelerometer worn during hospitalization and 7-14 days thereafter. RESULTS A total of 42 controls (mean age = 59 years, 62% male) and 52 intervention patients (58 years, 52%) were included. The exercise movie, paper information and Fitbit Flex were the three most frequently used components, with highest satisfaction scores for the fitbit, paper information, exercise movie and digital training. Median sedentary time decreased from 99.6% to 95.7% and 99.3% to 91.0% between Days 1 and 6 in patients admitted in the control and intervention phases, respectively. The difference at Day 6 reached statistical significance (difference = 41 min/day, P  = 0.01). No differences were seen after discharge. CONCLUSION Implementing a multicomponent intervention to reduce sedentary time appeared feasible and may be effective during but not directly after hospitalization.",2020,"Median sedentary time decreased from 99.6% to 95.7% and 99.3% to 91.0% between Days 1 and 6 in patients admitted in the control and intervention phases, respectively.","['The study was conducted in a university hospital', 'patients admitted before and after the implementation of the intervention', 'A total of 42 controls (mean age = 59\u2009years, 62% male) and 52 intervention patients (58\u2009years, 52%) were included', 'Participants were adult patients undergoing elective organ transplantation or vascular surgery']","['digital information, an exercise movie, an activity planner, a pedometer and Fitbit Flex™, a personal activity coach and an individualized digital training program', 'multicomponent intervention']","['Median sedentary time', 'sedentary time', 'median % of sedentary time measured by an accelerometer worn during hospitalization']","[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0029216', 'cui_str': 'Organ transplant'}, {'cui': 'C0042381', 'cui_str': 'Vascular surgery procedure'}]","[{'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0681495', 'cui_str': 'Movies'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0557773', 'cui_str': 'Coach'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}]",,0.0189748,"Median sedentary time decreased from 99.6% to 95.7% and 99.3% to 91.0% between Days 1 and 6 in patients admitted in the control and intervention phases, respectively.","[{'ForeName': 'D', 'Initials': 'D', 'LastName': 'Conijn', 'Affiliation': 'Department of Orthopaedics, Rehabilitation and Physical Therapy, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'van Bodegom-Vos', 'Affiliation': 'Department of Biomedical Data Sciences, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'W G', 'Initials': 'WG', 'LastName': 'Volker', 'Affiliation': 'Department for Innovation, Quality + Research, Basalt Rehabilitation Center, The Hague/Leiden, The Netherlands.'}, {'ForeName': 'Bja', 'Initials': 'B', 'LastName': 'Mertens', 'Affiliation': 'Department of Biomedical Data Sciences, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'H M', 'Initials': 'HM', 'LastName': 'Vermeulen', 'Affiliation': 'Department of Orthopaedics, Rehabilitation and Physical Therapy, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Val', 'Initials': 'V', 'LastName': 'Huurman', 'Affiliation': 'Department of Transplantation Surgery, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'van Schaik', 'Affiliation': 'Department of Vascular Surgery, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Tpm', 'Initials': 'T', 'LastName': 'Vliet Vlieland', 'Affiliation': 'Department of Orthopaedics, Rehabilitation and Physical Therapy, Leiden University Medical Center, Leiden, The Netherlands.'}, {'ForeName': 'Jjl', 'Initials': 'J', 'LastName': 'Meesters', 'Affiliation': 'Department of Orthopaedics, Rehabilitation and Physical Therapy, Leiden University Medical Center, Leiden, The Netherlands.'}]",Clinical rehabilitation,['10.1177/0269215520920662'] 2015,32476482,Acceptance and commitment therapy for the treatment of depression in persons with physical disability: a randomized controlled trial.,"OBJECTIVE To evaluate the effectiveness of acceptance and commitment therapy (ACT) on depressive symptoms in physically disabled persons. DESIGN Randomized controlled trial. SETTING State welfare organization in Kamyaran, Kurdistan, Iran. PARTICIPANTS Fifty-two physically disabled participants with a primary diagnosis of depression were randomly assigned to either ACT or control groups. INTERVENTIONS Participants in the ACT group ( n  = 23) received eight weekly 90-minute group sessions based on standard ACT protocol for depression. Participants in the control group ( n  = 29) received psychoeducation regarding depression. MAIN MEASURES Measures were recorded at baseline, eight weeks (end of treatment), and 16 weeks (follow-up). The outcomes were the change in the depressive symptoms, measured by Beck Depression Inventory-II (BDI-II), psychological flexibility, emotion regulation, and psychological well-being measured by Acceptance and Action Questionnaire-II (AAQ-II), Emotion Regulation Questionnaire (ERQ), and Scales of Psychological Well-Being (SPWB), respectively. RESULTS After eight weeks, significant changes in depressive symptoms was observed in the experimental group (ACT -10.39 ± 0.79 vs control 0.66 ± 0.68, P  < 0.001). Compared to the control group, the experimental group also showed significant improvement in psychological flexibility (ACT 8.13 ± 0.52 vs control -0.03 ± 0.51, P  < 0.001), adaptive emotion regulation strategies (ACT 10.74 ± 0.62 vs control 0.03 ± 1.03, P  < 0.001), and psychological well-being (ACT 66.95 ± 4.01 vs control -1.90 ± 1.04, P  < 0.001). CONCLUSION Compared with control group, ACT significantly reduced the participants' depression, and changed psychological flexibility, emotion regulation, and psychological well-being in persons with physical disability.",2020,"Compared with control group, ACT significantly reduced the participants' depression, and changed psychological flexibility, emotion regulation, and psychological well-being in persons with physical disability.","['Participants in the ACT group ( n \u2009=\u200923', 'physically disabled persons', 'State welfare organization in Kamyaran, Kurdistan, Iran', 'Fifty-two physically disabled participants with a primary diagnosis of depression', 'persons with physical disability']","['acceptance and commitment therapy (ACT', 'ACT or control groups', 'psychoeducation regarding depression', 'standard ACT protocol']","[""participants' depression, and changed psychological flexibility, emotion regulation, and psychological well-being in persons with physical disability"", 'depressive symptoms, measured by Beck Depression Inventory-II (BDI-II), psychological flexibility, emotion regulation, and psychological well-being measured by Acceptance and Action Questionnaire-II (AAQ-II), Emotion Regulation Questionnaire (ERQ), and Scales of Psychological Well-Being (SPWB), respectively', 'psychological flexibility', 'adaptive emotion regulation strategies', 'depressive symptoms']","[{'cui': 'C0029917', 'cui_str': 'Outpatient Commitment'}, {'cui': 'C1527374', 'cui_str': 'Group Therapy'}, {'cui': 'C0086807', 'cui_str': 'Physically Disabled'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0037440', 'cui_str': 'Social services'}, {'cui': 'C0029237', 'cui_str': 'Organization'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C4319570', 'cui_str': '52'}, {'cui': 'C0332137', 'cui_str': 'Principal diagnosis'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0520817', 'cui_str': 'Physical handicap'}]","[{'cui': 'C3658321', 'cui_str': 'Acceptance and commitment therapy'}, {'cui': 'C0029917', 'cui_str': 'Outpatient Commitment'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0871175', 'cui_str': 'Psychoeducation'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]","[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}, {'cui': 'C0424578', 'cui_str': 'Well in self'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0520817', 'cui_str': 'Physical handicap'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",52.0,0.106167,"Compared with control group, ACT significantly reduced the participants' depression, and changed psychological flexibility, emotion regulation, and psychological well-being in persons with physical disability.","[{'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Zemestani', 'Affiliation': 'Department of Clinical Psychology, University of Kurdistan, Sanandaj, Iran.'}, {'ForeName': 'Sharmin', 'Initials': 'S', 'LastName': 'Mozaffari', 'Affiliation': 'Department of Clinical Psychology, University of Kurdistan, Sanandaj, Iran.'}]",Clinical rehabilitation,['10.1177/0269215520923135'] 2016,32483147,"Analysis of immune, microbiota and metabolome maturation in infants in a clinical trial of Lactobacillus paracasei CBA L74-fermented formula.","Mother's milk is the best choice for infants nutrition, however when it is not available or insufficient to satisfy the needs of the infant, formula is proposed as an effective substitute. Here, we report the results of a randomized controlled clinical trial (NCT03637894) designed to evaluate the effects of two different dietary regimens (standard formula and Lactobacillus paracasei CBA L74-fermented formula) versus breastfeeding (reference group) on immune defense mechanisms (primary endpoint: secretory IgA, antimicrobial peptides), the microbiota and its metabolome (secondary outcomes), in healthy full term infants according to the type of delivery (n = 13/group). We show that the fermented formula, safe and well tolerated, induces an increase in secretory IgA (but not in antimicrobial peptides) and reduces the diversity of the microbiota, similarly, but not as much as, breastmilk. Metabolome analysis allowed us to distinguish subjects based on their dietary regimen and mode of delivery. Together, these results suggest that a fermented formula favors the maturation of the immune system, microbiota and metabolome.",2020,"We show that the fermented formula, safe and well tolerated, induces an increase in secretory IgA (but not in antimicrobial peptides) and reduces the diversity of the microbiota, similarly, but not as much as, breastmilk.",['healthy full term infants according to the type of delivery (n\u2009=\u200913/group'],"['Lactobacillus paracasei CBA', 'dietary regimens (standard formula and Lactobacillus paracasei CBA L74-fermented formula']","['secretory IgA', 'safe and well tolerated']","[{'cui': 'C4551581', 'cui_str': 'Term baby'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}]","[{'cui': 'C1080735', 'cui_str': 'Lactobacillus paracasei'}, {'cui': 'C0025922', 'cui_str': 'Mouse, Inbred CBA'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C3853255', 'cui_str': 'Standard formula'}]","[{'cui': 'C0020838', 'cui_str': 'Immunoglobulin A secretory'}]",,0.03072,"We show that the fermented formula, safe and well tolerated, induces an increase in secretory IgA (but not in antimicrobial peptides) and reduces the diversity of the microbiota, similarly, but not as much as, breastmilk.","[{'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Roggero', 'Affiliation': ""Neonatal Intensive Care Unit, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico (IRCCS), Milan, Italy. paola.roggero@unimi.it.""}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Liotto', 'Affiliation': ""Neonatal Intensive Care Unit, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico (IRCCS), Milan, Italy.""}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Pozzi', 'Affiliation': 'Humanitas Clinical and Research Center-IRCCS, Via Manzoni 56, 20089 Rozzano, Milan, Italy.'}, {'ForeName': 'Daniele', 'Initials': 'D', 'LastName': 'Braga', 'Affiliation': 'Humanitas Clinical and Research Center-IRCCS, Via Manzoni 56, 20089 Rozzano, Milan, Italy.'}, {'ForeName': 'Jacopo', 'Initials': 'J', 'LastName': 'Troisi', 'Affiliation': 'Theoreo Srl, Via degli Ulivi 3, 84090, Montecorvino Pugliano, SA, Italy.'}, {'ForeName': 'Camilla', 'Initials': 'C', 'LastName': 'Menis', 'Affiliation': ""Neonatal Intensive Care Unit, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico (IRCCS), Milan, Italy.""}, {'ForeName': 'Maria Lorella', 'Initials': 'ML', 'LastName': 'Giannì', 'Affiliation': ""Neonatal Intensive Care Unit, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico (IRCCS), Milan, Italy.""}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Berni Canani', 'Affiliation': 'Department of Translational Medical Science, University Federico II, Naples, Italy.'}, {'ForeName': 'Lorella', 'Initials': 'L', 'LastName': 'Paparo', 'Affiliation': 'Department of Translational Medical Science, University Federico II, Naples, Italy.'}, {'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Nocerino', 'Affiliation': 'Department of Translational Medical Science, University Federico II, Naples, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Budelli', 'Affiliation': 'School of Engineering, Niccoló Cusano University, Rome, Italy.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Mosca', 'Affiliation': ""Neonatal Intensive Care Unit, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico (IRCCS), Milan, Italy.""}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Rescigno', 'Affiliation': 'Humanitas Clinical and Research Center-IRCCS, Via Manzoni 56, 20089 Rozzano, Milan, Italy. maria.rescigno@hunimed.eu.'}]",Nature communications,['10.1038/s41467-020-16582-1'] 2017,32480319,Effectiveness of an app-based cognitive behavioral therapy program for postpartum depression in primary care: A randomized controlled trial.,"OBJECTIVE The objective of this study was to examine the effect of mobile phone applications (App) based cognitive behavioral therapy (CBT) on postpartum depression. METHOD A non-blinded parallel-group randomized controlled trial was conducted. The study population consisted of women attended to three health care centers in Kerman, Iran. Participants were recruited between September and November 2018, and randomized 1:1 to either the intervention group (mobile application access) or control group (no mobile application access). All participants completed the Edinburgh Postnatal Depression Scale (EPDS) at the baseline and 2 months after baseline. Data were analyzed using inferential statistics including chi-square, independent sample t-test, paired t-test and linear regression. RESULTS A total of 75 women with an average age of 27 years participated in this study. Before the intervention, there was no statistically significant difference between the EPDS score between the two groups (p > 0.001). However, in the intervention group, the average EPDS score after intervention was 8.18 and in the control group was 15.05, which was statistically significant (p < 0.001). CONCLUSION These findings provide proof that providing a CBT program using a mobile application can lead to clinically important improvements in outcomes for mothers who suffer from postpartum depression.",2020,"Before the intervention, there was no statistically significant difference between the EPDS score between the two groups (p > 0.001).","['Participants were recruited between September and November 2018', 'postpartum depression in primary care', 'women attended to three health care centers in Kerman, Iran', 'mothers who suffer from postpartum depression', '75 women with an average age of 27 years participated in this study']","['intervention group (mobile application access) or control group (no mobile application access', 'app-based cognitive behavioral therapy program', 'mobile phone applications (App) based cognitive behavioral therapy (CBT']","['Edinburgh Postnatal Depression Scale (EPDS', 'average EPDS score', 'EPDS score']","[{'cui': 'C0221074', 'cui_str': 'Postpartum depression'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C1136360', 'cui_str': 'Car Phone'}, {'cui': 'C0185125', 'cui_str': 'Application'}]","[{'cui': 'C0451144', 'cui_str': 'Edinburgh postnatal depression scale'}, {'cui': 'C3472185', 'cui_str': 'Edinburgh postnatal depression scale score'}]",75.0,0.174326,"Before the intervention, there was no statistically significant difference between the EPDS score between the two groups (p > 0.001).","[{'ForeName': 'Nazanin', 'Initials': 'N', 'LastName': 'Jannati', 'Affiliation': 'Neuroscience Research Center, Institute of Neuropharmacology, Kerman University of Medical Sciences, Kerman, Iran.'}, {'ForeName': 'Shahrzad', 'Initials': 'S', 'LastName': 'Mazhari', 'Affiliation': 'Neuroscience Research Center, Institute of Neuropharmacology, Kerman University of Medical Sciences, Kerman, Iran.'}, {'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Ahmadian', 'Affiliation': 'Medical Informatics Research Center, Institute for Futures Studies in Health, Kerman University of Medical Sciences, Kerman, Iran. Electronic address: ahmadianle@yahoo.com.'}, {'ForeName': 'Moghaddameh', 'Initials': 'M', 'LastName': 'Mirzaee', 'Affiliation': 'Epidemiology and Biostatistics, Kerman University of Medical Sciences, Kerman, Iran.'}]",International journal of medical informatics,['10.1016/j.ijmedinf.2020.104145'] 2018,32487567,"Osimertinib Called ""Home Run"" for EGFR -Mutant NSCLC.","Adjuvant treatment with the tyrosine kinase inhibitor osimertinib will likely become a new standard of care in patients with EGFR -mutant non-small cell lung cancer. In the phase III ADAURA trial, 90% of patients with stage II-IIIA disease who received osimertinib were alive and free of cancer at 2 years, compared with 44% who received a placebo-results considered so striking that researchers unblinded the trial early.",2020,Adjuvant treatment with the tyrosine kinase inhibitor osimertinib will likely become a new standard of care in patients with EGFR -mutant non-small cell lung cancer.,"['patients with stage II-IIIA disease who received osimertinib were alive and free of cancer at 2 years', 'patients with EGFR -mutant non-small cell lung cancer']",['placebo'],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C4058811', 'cui_str': 'osimertinib'}, {'cui': 'C2584946', 'cui_str': 'Alive'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],90.0,0.0800407,Adjuvant treatment with the tyrosine kinase inhibitor osimertinib will likely become a new standard of care in patients with EGFR -mutant non-small cell lung cancer.,[],Cancer discovery,['10.1158/2159-8290.CD-NB2020-053'] 2019,32487568,Trastuzumab Deruxtecan DESTINY for Some Cancers.,"Trastuzumab deruxtecan may be effective in solid cancers in addition to breast cancer. In a randomized phase II trial of HER2-positive gastric and gastroesophageal junction cancers, the agent significantly extended overall survival and progression-free survival compared with standard chemotherapy. It also elicited high response rates in phase II trials of HER2-mutant non-small cell lung cancer and HER2-positive colorectal cancer.",2020,"In a randomized phase II trial of HER2-positive gastric and gastroesophageal junction cancers, the agent significantly extended overall survival and progression-free survival compared with standard chemotherapy.",['Solid Cancers'],"['Trastuzumab deruxtecan', 'standard chemotherapy']",['overall survival and progression-free survival'],"[{'cui': 'C0205208', 'cui_str': 'Solid'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}]","[{'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",,0.0396085,"In a randomized phase II trial of HER2-positive gastric and gastroesophageal junction cancers, the agent significantly extended overall survival and progression-free survival compared with standard chemotherapy.",[],Cancer discovery,['10.1158/2159-8290.CD-ND2020-011'] 2020,32488923,Ultra rapid lispro improves postprandial glucose control compared with lispro in patients with type 1 diabetes: Results from the 26-week PRONTO-T1D study.,"AIMS To evaluate the efficacy and safety of ultra rapid lispro (URLi) versus lispro in adults with type 1 diabetes in a 26-week, treat-to-target, phase 3 trial. MATERIALS AND METHODS After an 8-week lead-in to optimize basal insulin glargine or degludec, patients were randomized to double-blind mealtime URLi (n = 451) or lispro (n = 442), or open-label post-meal URLi (n = 329). The primary endpoint was change from baseline glycated haemoglobin (HbA1c) to 26 weeks (non-inferiority margin 0.4%), with multiplicity-adjusted objectives for postprandial glucose (PPG) excursions after a meal test. RESULTS Both mealtime and post-meal URLi demonstrated non-inferiority to lispro for HbA1c: estimated treatment difference (ETD) for mealtime URLi -0.08% [95% confidence interval (CI) -0.16, 0.00] and for post-meal URLi +0.13% (95% CI 0.04, 0.22), with a significantly higher endpoint HbA1c for post-meal URLi versus lispro (P = 0.003). Mealtime URLi was superior to lispro in reducing 1- and 2-hour PPG excursions during the meal test: ETD -1.55 mmol/L (95% CI -1.96, -1.14) at 1 hour and - 1.73 mmol/L (95% CI -2.28, -1.18) at 2 hours (both P < 0.001). The rate and incidence of severe, documented and postprandial hypoglycaemia (<3.0 mmol/L) was similar between treatments, but mealtime URLi demonstrated a 37% lower rate in the period >4 hours after meals (P = 0.013). Injection site reactions were reported by 2.9% of patients on mealtime URLi, 2.4% on post-meal URLi, and 0.2% on lispro. Overall, the incidence of treatment-emergent adverse events was similar between treatments. CONCLUSIONS The results showed that URLi provided good glycaemic control, with non-inferiority to lispro confirmed for both mealtime and post-meal URLi, while superior PPG control was demonstrated with mealtime dosing.",2020,"Both mealtime and postmeal URLi demonstrated noninferiority to lispro for HbA1c: estimated treatment difference (ETD) mealtime URLi, -0.08% [95% CI -0.16, 0.00], and postmeal URLi +0.13% [0.04, 0.22]; with a significantly higher endpoint HbA1c for postmeal URLi versus lispro (p=0.003).","['adults with type 1 diabetes', 'Patients With Type 1 Diabetes']","['ultra rapid lispro (URLi) versus lispro', 'Ultra Rapid Lispro', 'double-blind mealtime URLi (n=451) or lispro (n=442), or open-label postmeal URLi', 'Lispro']","['Postprandial Glucose Control', 'incidence of treatment-emergent adverse events', 'rate and incidence of severe, documented and postprandial hypoglycaemia', 'Injection site reactions', 'postprandial glucose (PPG) excursions', '1- and 2-h PPG excursions']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0293359', 'cui_str': 'Insulin Lispro'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}, {'cui': 'C0587119', 'cui_str': 'Mealtimes'}, {'cui': 'C0175566', 'cui_str': 'Open'}]","[{'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0271710', 'cui_str': 'Reactive hypoglycemia'}, {'cui': 'C0151735', 'cui_str': 'Injection site reaction'}, {'cui': 'C0011744', 'cui_str': 'Deuterium'}]",,0.0808552,"Both mealtime and postmeal URLi demonstrated noninferiority to lispro for HbA1c: estimated treatment difference (ETD) mealtime URLi, -0.08% [95% CI -0.16, 0.00], and postmeal URLi +0.13% [0.04, 0.22]; with a significantly higher endpoint HbA1c for postmeal URLi versus lispro (p=0.003).","[{'ForeName': 'Leslie', 'Initials': 'L', 'LastName': 'Klaff', 'Affiliation': 'Rainier CRC, Renton, Washington, USA.'}, {'ForeName': 'Dachuang', 'Initials': 'D', 'LastName': 'Cao', 'Affiliation': 'Eli Lilly and Company, Lilly Corporate Center, Indianapolis, Indiana, USA.'}, {'ForeName': 'Mary Anne', 'Initials': 'MA', 'LastName': 'Dellva', 'Affiliation': 'Eli Lilly and Company, Lilly Corporate Center, Indianapolis, Indiana, USA.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Tobian', 'Affiliation': 'Eli Lilly and Company, Lilly Corporate Center, Indianapolis, Indiana, USA.'}, {'ForeName': 'Junnosuke', 'Initials': 'J', 'LastName': 'Miura', 'Affiliation': ""Tokyo Women's Medical University School of Medicine, Tokyo, Japan.""}, {'ForeName': 'Dominik', 'Initials': 'D', 'LastName': 'Dahl', 'Affiliation': 'Gemeinschaftspraxis fur Innere Medizin und Diabetologie, Hamburg, Germany.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Lucas', 'Affiliation': 'Lucas Research, Morehead City, North Carolina, USA.'}, {'ForeName': 'Juliana', 'Initials': 'J', 'LastName': 'Bue-Valleskey', 'Affiliation': 'Eli Lilly and Company, Lilly Corporate Center, Indianapolis, Indiana, USA.'}]","Diabetes, obesity & metabolism",['10.1111/dom.14100'] 2021,32589977,"Selinexor in patients with relapsed or refractory diffuse large B-cell lymphoma (SADAL): a single-arm, multinational, multicentre, open-label, phase 2 trial.","BACKGROUND Relapsed or refractory diffuse large B-cell lymphoma (DLBCL) is an aggressive cancer with a median overall survival of less than 6 months. We aimed to assess the response to single-agent selinexor, an oral selective inhibitor of nuclear export, in patients with relapsed or refractory DLBCL who had no therapeutic options of potential clinical benefit. METHODS SADAL was a multicentre, multinational, open-label, phase 2b study done in 59 sites in 19 countries. Patients aged 18 years or older with pathologically confirmed diffuse large B-cell lymphoma, an Eastern Cooperative Oncology Group performance status of 2 or less, who had received two to five lines of previous therapies, and progressed after or were not candidates for autologous stem-cell transplantation were enrolled. Germinal centre B-cell or non-germinal centre B-cell tumour subtype and double or triple expressor status were determined by immunohistochemistry and double or triple hit status was determined by cytogenetics. Patients received 60 mg selinexor orally on days 1 and 3 weekly until disease progression or unacceptable toxicity. The study was initially designed to evaluate both 60 mg and 100 mg twice-weekly doses of selinexor; however, the 100 mg dose was discontinued in the protocol (version 7.0) on March 29, 2017, when an improved therapeutic window was observed at 60 mg. Primary outcome was overall response rate. The primary outcome and safety were assessed in all patients who received 60 mg selinexor under protocol version 6.0, or enrolled under protocol versions 7.0 or higher and received at least one dose of selinexor. This trial is registered at ClinicalTrials.gov, NCT02227251 (active but not enrolling). FINDINGS Between Oct 21, 2015, and Nov 2, 2019, 267 patients were randomly assigned, with 175 allocated to the 60 mg group and 92 to the discontinued 100 mg group. 48 patients assigned to the 60 mg group were excluded due to enrolment before version 6.0 of the protocol; the remaining 127 patients received selinexor 60 mg and were included in analyses of primary outcome and safety. The overall response rate was 28% (36/127; 95% CI 20·7-37·0); 15 (12%) achieved a complete response and 21 (17%) a partial response. The most common grade 3-4 adverse events were thrombocytopenia (n=58), neutropenia (n=31), anaemia (n=28), fatigue (n=14), hyponatraemia (n=10), and nausea (n=8). The most common serious adverse events were pyrexia (n=9), pneumonia (n=6), and sepsis (n=6). There were no deaths judged as related to treatment with selinexor. INTERPRETATION Single-drug oral selinexor induced durable responses and had a manageable adverse events profile in patients with relapsed or refractory DLBCL who received at least two lines of previous chemoimmunotherapy. Selinexor could be considered a new oral, non-cytotoxic treatment option in this setting. FUNDING Karyopharm Therapeutics Inc.",2020,The overall response rate was 28% (36/127; 95% CI 20·7-37·0); 15 (12%) achieved a complete response and 21 (17%) a partial response.,"['patients with relapsed or refractory DLBCL who received at least two lines of previous', '48 patients assigned to the 60 mg group were excluded due to enrolment before version 6.0 of the protocol; the remaining 127 patients received', 'n=31), anaemia (n=28), fatigue (n=14), hyponatraemia (n=10), and nausea (n=8', 'SADAL was a multicentre, multinational, open-label, phase 2b study done in 59 sites in 19 countries', 'patients with relapsed or refractory DLBCL who had no therapeutic options of potential clinical benefit', 'patients with relapsed or refractory diffuse large B-cell lymphoma (SADAL', 'Between Oct 21, 2015, and Nov 2, 2019, 267 patients', 'Patients aged 18 years or older with pathologically confirmed diffuse large B-cell lymphoma, an Eastern Cooperative Oncology Group performance status of 2 or less, who had received two to five lines of previous therapies, and progressed after or were not candidates for autologous stem-cell transplantation were enrolled']","['Selinexor', 'chemoimmunotherapy', 'selinexor']","['overall response rate', 'neutropenia']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0855112', 'cui_str': 'Diffuse large B-cell lymphoma refractory'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0020625', 'cui_str': 'Hyponatremia'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C1278569', 'cui_str': 'WAS A'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0029279', 'cui_str': 'Ornithine carbamoyltransferase'}, {'cui': 'C0949920', 'cui_str': 'Norovirus'}, {'cui': 'C4517672', 'cui_str': '267'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0079744', 'cui_str': 'Malignant lymphoma, large B-cell, diffuse'}, {'cui': 'C1520224', 'cui_str': 'ECOG performance status'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C1831743', 'cui_str': 'Transplantation of autologous hematopoietic stem cell'}]","[{'cui': 'C3852671', 'cui_str': 'Selinexor'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}]",267.0,0.466967,The overall response rate was 28% (36/127; 95% CI 20·7-37·0); 15 (12%) achieved a complete response and 21 (17%) a partial response.,"[{'ForeName': 'Nagesh', 'Initials': 'N', 'LastName': 'Kalakonda', 'Affiliation': 'University of Liverpool, Liverpool, UK. Electronic address: nagesh.kalakonda@liverpool.ac.uk.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Maerevoet', 'Affiliation': 'Institut Jules Bordet, Brussels, Belgium.'}, {'ForeName': 'Federica', 'Initials': 'F', 'LastName': 'Cavallo', 'Affiliation': 'Department of Molecular Biotechnologies and Health Sciences, Division of Hematology, University of Torino, Turin, Italy.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Follows', 'Affiliation': ""Addenbrooke's Hospital, Cambridge, UK.""}, {'ForeName': 'Andre', 'Initials': 'A', 'LastName': 'Goy', 'Affiliation': 'John Theurer Cancer Center, Hackensack University Medical Center, Hackensack, NJ, USA.'}, {'ForeName': 'Joost S P', 'Initials': 'JSP', 'LastName': 'Vermaat', 'Affiliation': 'Leiden University Medical Center, Leiden, Netherlands.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Casasnovas', 'Affiliation': 'Hématologie Clinique, Dijon, France.'}, {'ForeName': 'Nada', 'Initials': 'N', 'LastName': 'Hamad', 'Affiliation': ""St Vincent's Hospital Sydney, Darlinghurst, NSW, Australia.""}, {'ForeName': 'Josée M', 'Initials': 'JM', 'LastName': 'Zijlstra', 'Affiliation': 'Amsterdam UMC, Vrije Universiteit, Cancer Center, Amsterdam, Netherlands.'}, {'ForeName': 'Sameer', 'Initials': 'S', 'LastName': 'Bakhshi', 'Affiliation': 'Dr B R Ambedkar Institute Rotary Cancer Hospital AIIMS, New Delhi, India.'}, {'ForeName': 'Reda', 'Initials': 'R', 'LastName': 'Bouabdallah', 'Affiliation': 'Institut Paoli-Calmettes, Marseille, France.'}, {'ForeName': 'Sylvain', 'Initials': 'S', 'LastName': 'Choquet', 'Affiliation': 'Hôpital Pitié Salpêtrière, Paris, France.'}, {'ForeName': 'Ronit', 'Initials': 'R', 'LastName': 'Gurion', 'Affiliation': 'Rabin Medical Centre, Petah Tiqwa, Israel; Tel Aviv University, Petah Tiqwa, Israel.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Hill', 'Affiliation': 'Cleveland Clinic, Cleveland, OH, USA.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Jaeger', 'Affiliation': 'Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Juan Manuel', 'Initials': 'JM', 'LastName': 'Sancho', 'Affiliation': 'ICO-IJC Hospital Universitari Germans Trias I Pujol, Barcelona, Spain.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Schuster', 'Affiliation': 'Stony Brook University, Stony Brook NY, USA.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Thieblemont', 'Affiliation': 'Saint-Louis Hospital, Paris, France; Paris Diderot University, Paris, France.'}, {'ForeName': 'Fátima', 'Initials': 'F', 'LastName': 'De la Cruz', 'Affiliation': 'Hospital Universitario Virgen del Rocio, Sevilla, Spain.'}, {'ForeName': 'Miklos', 'Initials': 'M', 'LastName': 'Egyed', 'Affiliation': 'Teaching Hospital Mór Kaposi, Kaposvár, Hungary.'}, {'ForeName': 'Sourav', 'Initials': 'S', 'LastName': 'Mishra', 'Affiliation': 'Institute of Medical Sciences & SUM Hospital, Odisha, India.'}, {'ForeName': 'Fritz', 'Initials': 'F', 'LastName': 'Offner', 'Affiliation': 'Gent University Hospital, Gent Belgium.'}, {'ForeName': 'Theodoros P', 'Initials': 'TP', 'LastName': 'Vassilakopoulos', 'Affiliation': 'Laikon General Hospital National, Athens, Greece; Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Krzysztof', 'Initials': 'K', 'LastName': 'Warzocha', 'Affiliation': 'Instytut Hematologii i Transfuzjologii, Warszawa, Poland.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'McCarthy', 'Affiliation': 'Karyopharm Therapeutics Inc, Newton, MA, USA.'}, {'ForeName': 'Xiwen', 'Initials': 'X', 'LastName': 'Ma', 'Affiliation': 'Karyopharm Therapeutics Inc, Newton, MA, USA.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Corona', 'Affiliation': 'Karyopharm Therapeutics Inc, Newton, MA, USA.'}, {'ForeName': 'Jean-Richard', 'Initials': 'JR', 'LastName': 'Saint-Martin', 'Affiliation': 'Karyopharm Therapeutics Inc, Newton, MA, USA.'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Chang', 'Affiliation': 'Karyopharm Therapeutics Inc, Newton, MA, USA.'}, {'ForeName': 'Yosef', 'Initials': 'Y', 'LastName': 'Landesman', 'Affiliation': 'Karyopharm Therapeutics Inc, Newton, MA, USA.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Joshi', 'Affiliation': 'Karyopharm Therapeutics Inc, Newton, MA, USA.'}, {'ForeName': 'Hongwei', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Karyopharm Therapeutics Inc, Newton, MA, USA.'}, {'ForeName': 'Jatin', 'Initials': 'J', 'LastName': 'Shah', 'Affiliation': 'Karyopharm Therapeutics Inc, Newton, MA, USA.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Shacham', 'Affiliation': 'Karyopharm Therapeutics Inc, Newton, MA, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Kauffman', 'Affiliation': 'Karyopharm Therapeutics Inc, Newton, MA, USA.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Van Den Neste', 'Affiliation': 'Cliniques Universitaires Saint-Luc, Brussels, Belgium.'}, {'ForeName': 'Miguel A', 'Initials': 'MA', 'LastName': 'Canales', 'Affiliation': 'Hospital Universitario La Paz, Madrid, Spain.'}]",The Lancet. Haematology,['10.1016/S2352-3026(20)30120-4'] 2022,32590137,Bone turnover markers in children living with HIV remaining on ritonavir-boosted lopinavir or switching to efavirenz.,"INTRODUCTION We previously found lower bone mass but similar bone turnover in pre-pubertal children living with HIV (CLWH) on a ritonavir-boosted lopinavir (LPV/r)-based vs. efavirenz-based antiretroviral therapy regimen 2 years after switch. Here, we evaluate if bone turnover differed between the groups close to the time of switch. METHODS Samples from 108 children remaining on LPV/r and 104 children switched to efavirenz were available for analysis 8 weeks post-randomization. Bone turnover markers, including C-telopeptide of type 1 collagen (CTx), procollagen type-I N-terminal propeptide (P1NP), and osteocalcin were measured. Markers of immune activation were also measured, including IL-6, TNF-alpha, soluble CD14 and high-sensitivity C-reactive protein (CRP). RESULTS Eight weeks post-randomization, we did not detect differences in CTx (1.42 vs. 1.44 ng/mL, p = 0.85) or P1NP concentrations (622 vs. 513 ng/mL, p = 0.68) between treatment groups. At 8 weeks, the treatment groups also had similar levels of IL-6, TNF-alpha, soluble CD14 and high-sensitivity CRP. Osteocalcin (ng/mL) was higher in the LPV/r than efavirenz group both at 8 weeks (88.6 vs. 67.3, p = 0.001) and 2 years (67.6 vs. 49.8, p = 0.001). CONCLUSIONS Overall, we failed to detect difference in bone turnover by P1NP and CTx in virologically-suppressed CLWH on different regimens at a time point close to the switch. We did observe higher levels of total osteocalcin in children remaining on LPV/r compared to children switched to efavirenz. Future studies should focus on uncovering the mechanism and determining whether perturbation in undercarboxylated osteocalcin could explain some of the bone side effects noted with protease inhibitors.",2020,"At 8 weeks, the treatment groups also had similar levels of IL-6, TNF-alpha, soluble CD14 and high-sensitivity CRP.","['children living with HIV remaining on ritonavir-boosted lopinavir or switching to', 'Samples from 108 children remaining on LPV/r and 104 children switched to', 'pre-pubertal children living with HIV (CLWH) on a']","['efavirenz', 'ritonavir-boosted lopinavir (LPV/r)-based vs. efavirenz-based antiretroviral therapy']","['IL-6, TNF-alpha, soluble CD14 and high-sensitivity C-reactive protein (CRP', 'Bone turnover markers, including C-telopeptide of type 1 collagen (CTx), procollagen type-I N-terminal propeptide (P1NP), and osteocalcin', 'levels of IL-6, TNF-alpha, soluble CD14 and high-sensitivity CRP', 'Osteocalcin', 'bone turnover by P1NP and CTx', 'total osteocalcin', 'CTx', 'Bone turnover markers', 'bone turnover', 'P1NP concentrations', 'Markers of immune activation']","[{'cui': 'C0553288', 'cui_str': 'Lives with children'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0292818', 'cui_str': 'Ritonavir'}, {'cui': 'C0674432', 'cui_str': 'lopinavir'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C1628325', 'cui_str': 'Pre-pubertal'}]","[{'cui': 'C0674428', 'cui_str': 'efavirenz'}, {'cui': 'C0292818', 'cui_str': 'Ritonavir'}, {'cui': 'C0674432', 'cui_str': 'lopinavir'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}]","[{'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C1448177', 'cui_str': 'TNF protein, human'}, {'cui': 'C0108768', 'cui_str': 'Lymphocyte antigen CD14'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0085268', 'cui_str': 'Bone remodeling'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0631180', 'cui_str': 'C-telopeptide'}, {'cui': 'C0041455', 'cui_str': 'Collagen Type I'}, {'cui': 'C0041457', 'cui_str': 'Type I Procollagen'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0029419', 'cui_str': 'Osteocalcin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0072053', 'cui_str': 'Procollagen peptide, type 1 N-terminal'}, {'cui': 'C0010377', 'cui_str': 'Crotoxin'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0439662', 'cui_str': 'Immune'}]",,0.0664262,"At 8 weeks, the treatment groups also had similar levels of IL-6, TNF-alpha, soluble CD14 and high-sensitivity CRP.","[{'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Shiau', 'Affiliation': 'Department of Biostatistics and Epidemiology, Rutgers School of Public Health, Piscataway, NJ, USA.'}, {'ForeName': 'Michael T', 'Initials': 'MT', 'LastName': 'Yin', 'Affiliation': 'Department of Medicine, College of Physicians and Surgeons, Columbia University, New York, NY, USA.'}, {'ForeName': 'Renate', 'Initials': 'R', 'LastName': 'Strehlau', 'Affiliation': 'Empilweni Services and Research Unit, Rahima Moosa Mother and Child Hospital, Department of Pediatrics and Child Health, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Shen', 'Affiliation': 'Gertrude H. Sergievsky Center, College of Physicians and Surgeons, Columbia University, New York, NY, USA.'}, {'ForeName': 'Elaine J', 'Initials': 'EJ', 'LastName': 'Abrams', 'Affiliation': 'Department of Epidemiology, Mailman School of Public Health, Columbia University, New York, NY, USA; Department of Pediatrics, College of Physicians and Surgeons, Columbia University, New York, NY, USA; ICAP at Columbia, Mailman School of Public Health, Columbia University, New York, NY, USA.'}, {'ForeName': 'Ashraf', 'Initials': 'A', 'LastName': 'Coovadia', 'Affiliation': 'Empilweni Services and Research Unit, Rahima Moosa Mother and Child Hospital, Department of Pediatrics and Child Health, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Kuhn', 'Affiliation': 'Gertrude H. Sergievsky Center, College of Physicians and Surgeons, Columbia University, New York, NY, USA; Department of Epidemiology, Mailman School of Public Health, Columbia University, New York, NY, USA.'}, {'ForeName': 'Stephen M', 'Initials': 'SM', 'LastName': 'Arpadi', 'Affiliation': 'Gertrude H. Sergievsky Center, College of Physicians and Surgeons, Columbia University, New York, NY, USA; Department of Epidemiology, Mailman School of Public Health, Columbia University, New York, NY, USA; Department of Pediatrics, College of Physicians and Surgeons, Columbia University, New York, NY, USA; ICAP at Columbia, Mailman School of Public Health, Columbia University, New York, NY, USA. Electronic address: sma2@columbia.edu.'}]",Bone,['10.1016/j.bone.2020.115500'] 2023,32590148,Physical and mental health effects of repeated short walks in a blue space environment: A randomised crossover study.,"INTRODUCTION Blue spaces may benefit mental health and promote physical activity, although the evidence is still scarce. And benefits on physical health are less consistent. The objective of this randomized crossover study was to assess psychological and cardiovascular responses to blue spaces' exposure. METHODS A sample of 59 healthy adult office workers was randomly assigned to a different environment (i.e. blue space, urban space, and control site) on 4 days each week, for 3 weeks. For 20 min per day, they either walked along a blue or an urban space or rested at a control site. Before, during and/or after the exposure, we measured self-reported well-being and mood, blood pressure, and heart rate variability parameters. For well-being, we also assessed the duration of these potential effects over time (at least 4 h after exposure). RESULTS We found significantly improved well-being and mood responses immediately after walking in the blue space compared with walking in the urban space or when resting in the control site. Cardiovascular responses showed increased activity of the sympathetic nervous system, both during and after walking along the blue and urban spaces. However, cardiovascular responses measured after the walks, showed no statistically significant differences between the blue and the urban space environments. CONCLUSIONS Short walks in blue spaces can benefit both well-being and mood. However, we did not observe a positive effect of blue spaces for any of the cardiovascular outcomes assessed in this study.",2020,We found significantly improved well-being and mood responses immediately after walking in the blue space compared with walking in the urban space or when resting in the control site.,['59 healthy adult office workers'],[],"['psychological and cardiovascular responses', 'cardiovascular responses', 'self-reported well-being and mood, blood pressure, and heart rate variability parameters', 'well-being and mood responses', 'Physical and mental health effects']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C1306056', 'cui_str': 'Worker'}]",[],"[{'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",59.0,0.0763709,We found significantly improved well-being and mood responses immediately after walking in the blue space compared with walking in the urban space or when resting in the control site.,"[{'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Vert', 'Affiliation': 'ISGlobal, Barcelona, Spain; Universitat Pompeu Fabra (UPF), Barcelona, Spain; CIBER Epidemiología y Salud Pública (CIBERESP), Barcelona, Spain.'}, {'ForeName': 'Mireia', 'Initials': 'M', 'LastName': 'Gascon', 'Affiliation': 'ISGlobal, Barcelona, Spain; Universitat Pompeu Fabra (UPF), Barcelona, Spain; CIBER Epidemiología y Salud Pública (CIBERESP), Barcelona, Spain.'}, {'ForeName': 'Otavio', 'Initials': 'O', 'LastName': 'Ranzani', 'Affiliation': 'ISGlobal, Barcelona, Spain; Universitat Pompeu Fabra (UPF), Barcelona, Spain; CIBER Epidemiología y Salud Pública (CIBERESP), Barcelona, Spain.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Márquez', 'Affiliation': 'ISGlobal, Barcelona, Spain; Universitat Pompeu Fabra (UPF), Barcelona, Spain; CIBER Epidemiología y Salud Pública (CIBERESP), Barcelona, Spain.'}, {'ForeName': 'Margarita', 'Initials': 'M', 'LastName': 'Triguero-Mas', 'Affiliation': 'Universitat Autònoma de Barcelona, Barcelona, Spain; Institute for Environmental Science and Technology, Barcelona, Spain; IMIM (Hospital Del Mar Medical Research Institute), Barcelona, Spain; Barcelona Lab for Urban Environmental Justice and Sustainability, Barcelona, Spain.'}, {'ForeName': 'Glòria', 'Initials': 'G', 'LastName': 'Carrasco-Turigas', 'Affiliation': 'ISGlobal, Barcelona, Spain; Universitat Pompeu Fabra (UPF), Barcelona, Spain; CIBER Epidemiología y Salud Pública (CIBERESP), Barcelona, Spain.'}, {'ForeName': 'Lourdes', 'Initials': 'L', 'LastName': 'Arjona', 'Affiliation': 'ISGlobal, Barcelona, Spain; Universitat Pompeu Fabra (UPF), Barcelona, Spain; CIBER Epidemiología y Salud Pública (CIBERESP), Barcelona, Spain.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Koch', 'Affiliation': 'ISGlobal, Barcelona, Spain; Universitat Pompeu Fabra (UPF), Barcelona, Spain; CIBER Epidemiología y Salud Pública (CIBERESP), Barcelona, Spain.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Llopis', 'Affiliation': 'ISGlobal, Barcelona, Spain; Universitat Pompeu Fabra (UPF), Barcelona, Spain; CIBER Epidemiología y Salud Pública (CIBERESP), Barcelona, Spain.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Donaire-Gonzalez', 'Affiliation': 'Mary MacKillop Institute for Health Research, Australian Catholic University, Melbourne, VIC, Australia; Institute for Risk Assessment Sciences (IRAS), Division of Environmental Epidemiology (EEPI), Utrecht University, Utrecht, the Netherlands.'}, {'ForeName': 'Lewis R', 'Initials': 'LR', 'LastName': 'Elliott', 'Affiliation': 'European Centre for Environment and Human Health, University of Exeter Medical School, United Kingdom.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Nieuwenhuijsen', 'Affiliation': 'ISGlobal, Barcelona, Spain; Universitat Pompeu Fabra (UPF), Barcelona, Spain; CIBER Epidemiología y Salud Pública (CIBERESP), Barcelona, Spain. Electronic address: mark.nieuwenhuijsen@isglobal.org.'}]",Environmental research,['10.1016/j.envres.2020.109812'] 2024,32590214,Perceived social support and posttraumatic stress symptoms in children and youth in therapy: A parallel process latent growth curve model.,"Many studies show that perceived social support protects against the development of posttraumatic stress symptoms (PTSS) in the aftermath of trauma, but less is known about support in relation to PTSS in trauma therapy. This study examined associations between perceived social support and PTSS in children and adolescents during trauma therapy. Parallel process latent growth curve modeling was used to examine trajectories of perceived social support and PTSS over five measurement waves in a sample of 156 patients, aged between 10 and 18 years (M age = 15.1, SD = 2.2, 79.5% girls), randomized to receive trauma-focused cognitive behavior therapy (TF-CBT) or therapy-as-usual (TAU). Across all participants there was an average decline in PTSS and increase of perceived social support from pre-therapy to 18 months after therapy. Most of the change occurred during therapy and was maintained after therapy. Higher levels of PTSS prior to therapy were associated with lower levels of perceived social support prior to therapy, and a decrease in PTSS was associated with increase in perceived social support. This co-development may have been directed by a third underlying factor or short-term temporal effects. Studies investigating within-person associations over shorter time intervals will benefit our understanding of possible temporal effects.",2020,Across all participants there was an average decline in PTSS and increase of perceived social support from pre-therapy to 18 months after therapy.,"['children and adolescents during trauma therapy', '156 patients, aged between 10 and 18 years (M age\xa0=\xa015.1, SD\xa0=\xa02.2, 79.5% girls', 'children and youth in therapy']",['trauma-focused cognitive behavior therapy (TF-CBT) or therapy-as-usual (TAU'],"['Perceived social support and posttraumatic stress symptoms', 'PTSS', 'perceived social support']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C1320387', 'cui_str': 'Trauma therapy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517629', 'cui_str': '2.2'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C0521991', 'cui_str': 'Symptoms of stress'}]",156.0,0.02545,Across all participants there was an average decline in PTSS and increase of perceived social support from pre-therapy to 18 months after therapy.,"[{'ForeName': 'Marianne S', 'Initials': 'MS', 'LastName': 'Birkeland', 'Affiliation': 'Norwegian Centre for Violence and Traumatic Stress Studies, Norway. Electronic address: Marianne.s.birkeland@gmail.com.'}, {'ForeName': 'Tonje', 'Initials': 'T', 'LastName': 'Holt', 'Affiliation': 'Division of Mental & Physical Health, Norwegian Institute of Public Health, Norway.'}, {'ForeName': 'Silje M', 'Initials': 'SM', 'LastName': 'Ormhaug', 'Affiliation': 'Norwegian Centre for Violence and Traumatic Stress Studies, Norway.'}, {'ForeName': 'Tine K', 'Initials': 'TK', 'LastName': 'Jensen', 'Affiliation': 'Norwegian Centre for Violence and Traumatic Stress Studies, Norway; Department of Psychology, University of Oslo, Norway.'}]",Behaviour research and therapy,['10.1016/j.brat.2020.103655'] 2025,32590658,Feasibility of Surgeon-Delivered Audit and Feedback Incorporating Peer Surgical Coaching to Reduce Fistula Incidence following Cleft Palate Repair: A Pilot Trial.,"BACKGROUND Improving surgeons' technical performance may reduce their frequency of postoperative complications. The authors conducted a pilot trial to evaluate the feasibility of a surgeon-delivered audit and feedback intervention incorporating peer surgical coaching on technical performance among surgeons performing cleft palate repair, in advance of a future effectiveness trial. METHODS A nonrandomized, two-arm, unblinded pilot trial enrolled surgeons performing cleft palate repair. Participants completed a baseline audit of fistula incidence. Participants with a fistula incidence above the median were allocated to an intensive feedback intervention that included selecting a peer surgical coach, observing the coach perform palate repair, reviewing operative video of their own surgical technique with the coach, and proposing and implementing changes in their technique. All others were allocated to simple feedback (receiving audit results). Outcomes assessed were proportion of surgeons completing the baseline audit, disclosing their fistula incidence to peers, and completing the feedback intervention. RESULTS Seven surgeons enrolled in the trial. All seven completed the baseline audit and disclosed their fistula incidence to other participants. The median baseline fistula incidence was 0.4 percent (range, 0 to 10.5 percent). Two surgeons were unable to receive the feedback intervention. Of the five remaining surgeons, two were allocated to intensive feedback and three to simple feedback. All surgeons completed their assigned feedback intervention. Among surgeons receiving intensive feedback, fistula incidence was 5.9 percent at baseline and 0.0 percent following feedback (adjusted OR, 0.98; 95 percent CI, 0.44 to 2.17). CONCLUSION Surgeon-delivered audit and feedback incorporating peer coaching on technical performance was feasible for surgeons.",2020,"Participants with a fistula incidence above the median were allocated to an intensive feedback intervention that included selecting a peer surgical coach, observing the coach perform palate repair, reviewing operative video of their own surgical technique with the coach, and proposing and implementing changes in their technique.","['Participants with a fistula incidence above the median', 'Cleft Palate Repair', 'Seven surgeons enrolled in the trial', 'surgeons performing cleft palate repair']","['Surgeon-delivered audit and feedback incorporating peer coaching', 'intensive feedback intervention that included selecting a peer surgical coach, observing the coach perform palate repair, reviewing operative video of their own surgical technique with the coach, and proposing and implementing changes in their technique', 'Surgeon-Delivered Audit and Feedback Incorporating Peer Surgical Coaching', 'surgeon-delivered audit and feedback intervention incorporating peer surgical coaching', 'cleft palate repair']","['median baseline fistula incidence', 'proportion of surgeons completing the baseline audit, disclosing their fistula incidence to peers, and completing the feedback intervention', 'Fistula Incidence', 'fistula incidence']","[{'cui': 'C0016169', 'cui_str': 'Fistula'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0192086', 'cui_str': 'Repair of cleft palate'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0450985', 'cui_str': 'Alcohol use disorders identification test'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0557773', 'cui_str': 'Coach'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0337358', 'cui_str': 'Repair of palate'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0192086', 'cui_str': 'Repair of cleft palate'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0016169', 'cui_str': 'Fistula'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0450985', 'cui_str': 'Alcohol use disorders identification test'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",2.0,0.216518,"Participants with a fistula incidence above the median were allocated to an intensive feedback intervention that included selecting a peer surgical coach, observing the coach perform palate repair, reviewing operative video of their own surgical technique with the coach, and proposing and implementing changes in their technique.","[{'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Sitzman', 'Affiliation': ""Phoenix and Scottsdale, Ariz.; Seattle, Wash.; Durham, N.C.; Toronto and London, Ontario, Canada; Hershey, Pa.; and Akron and Cincinnati, Ohio From the Division of Plastic Surgery, Phoenix Children's Hospital; the Department of Surgery, Mayo Clinic College of Medicine; the Americleft Task Force Surgeon Subgroup; the Divisions of Craniofacial and Plastic Surgery and Plastic Surgery, Department of Surgery, Seattle Children's Hospital; the Division of Plastic, Maxillofacial & Oral Surgery, Duke University Hospital & Children's Health Center; the Cleft Lip and Palate Program, Division of Plastic Surgery, The Hospital for Sick Children; the Department of Surgery, University of Toronto; the Departments of Surgery, Pediatrics, and Neurosurgery, Penn State Hershey Medical Center; the Barrow Cleft and Craniofacial Center; the Division of Plastic and Reconstructive Surgery, Division of Paediatric Surgery, and the Department of Paediatrics, University of Western Ontario; Akron Children's Hospital; and the James M. Anderson Center for Health Systems Excellence, Cincinnati Children's Hospital Medical Center, and the University of Cincinnati College of Medicine.""}, {'ForeName': 'Raymond W', 'Initials': 'RW', 'LastName': 'Tse', 'Affiliation': ''}, {'ForeName': 'Alexander C', 'Initials': 'AC', 'LastName': 'Allori', 'Affiliation': ''}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Fisher', 'Affiliation': ''}, {'ForeName': 'Thomas D', 'Initials': 'TD', 'LastName': 'Samson', 'Affiliation': ''}, {'ForeName': 'Stephen P', 'Initials': 'SP', 'LastName': 'Beals', 'Affiliation': ''}, {'ForeName': 'Damir B', 'Initials': 'DB', 'LastName': 'Matic', 'Affiliation': ''}, {'ForeName': 'Jeffrey R', 'Initials': 'JR', 'LastName': 'Marcus', 'Affiliation': ''}, {'ForeName': 'Daniel H', 'Initials': 'DH', 'LastName': 'Grossoehme', 'Affiliation': ''}, {'ForeName': 'Maria T', 'Initials': 'MT', 'LastName': 'Britto', 'Affiliation': ''}]",Plastic and reconstructive surgery,['10.1097/PRS.0000000000006907'] 2026,32590726,Prediction of no-reflow phenomenon in patients treated with primary percutaneous coronary intervention for ST-segment elevation myocardial infarction.,"No-reflow is an important complication among patients with acute ST-segment elevation myocardial infarction (STEMI) undergoing percutaneous coronary intervention (PCI).A retrospective study of 1658 STEMI patients undergoing direct PCI was performed. Patients were randomly assigned at a 7:3 ratio into development cohort and validation cohort and into no-reflow and normal blood flow groups. Clinical data and laboratory examinations were compared to identify independent risk factors and establish a no-reflow risk scoring system.In the development cohort (n = 1122), 331 (29.5%) had no-reflow. Multivariate analysis showed age ≥ 65 years (OR = 1.766, 95% confidence interval (CI): 1.313-2.376, P < .001), not using angiotonase inhibitor/angiotensin receptor antagonists (OR = 1.454, 95%CI: 1.084-1.951, P = .013), collateral circulation 8 mmol/L (OR = 1.386, 95%CI: 1.007-1.908, P = .045) were related to no-reflow. Receiver operating characteristic (ROC) area under the curve was 0.648 (95%CI: 0.609-0.86). At 0.349 cutoff sensitivity was 42.0%, specificity was 79.3%, positive predictive value (PPV) was 44.7%, negative predictive value (NPV) was 77.4%, P < .001. The resulting risk scoring system was tested in the validation cohort (n = 536), with 30.1% incidence of no-reflow. The area under the ROC curve was 0.637 (95%CI: 0.582-0.692). At a cutoff of 0.349 sensitivity was 53.2% and specificity was 66.7%, PPV was 41.2%, NPV was 76.4%, P < .001.The no-reflow risk scoring system was effective in identifying high-risk patients.",2020,"At 0.349 cutoff sensitivity was 42.0%, specificity was 79.3%, positive predictive value (PPV) was 44.7%, negative predictive value (NPV) was 77.4%,","['patients treated with primary percutaneous coronary intervention for ST-segment elevation myocardial infarction', 'patients with acute ST-segment elevation myocardial infarction (STEMI) undergoing percutaneous coronary intervention (PCI).A retrospective study of 1658 STEMI patients undergoing']",['direct PCI'],"['positive predictive value (PPV', 'risk scoring system', 'thrombosis aspiration', 'negative predictive value (NPV', 'Receiver operating characteristic (ROC) area under the curve', 'collateral circulation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C1536220', 'cui_str': 'ST Segment Elevation Myocardial Infarction'}, {'cui': 'C1303258', 'cui_str': 'Acute ST segment elevation myocardial infarction'}, {'cui': 'C0441635', 'cui_str': 'Segment'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0035363', 'cui_str': 'Retrospective Study'}]","[{'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}]","[{'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0040053', 'cui_str': 'Thrombosis'}, {'cui': 'C0004056', 'cui_str': 'Aspiration, Psychology'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0009348', 'cui_str': 'Collateral circulation'}]",1658.0,0.10574,"At 0.349 cutoff sensitivity was 42.0%, specificity was 79.3%, positive predictive value (PPV) was 44.7%, negative predictive value (NPV) was 77.4%,","[{'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': 'Department of Cardiology, Tianjin Chest Hospital.'}, {'ForeName': 'Hongliang', 'Initials': 'H', 'LastName': 'Cong', 'Affiliation': 'Department of Cardiology, Tianjin Chest Hospital.'}, {'ForeName': 'Yali', 'Initials': 'Y', 'LastName': 'Lu', 'Affiliation': 'Department of Epidemiology and Health Statistics, School of Public Health, Tianjin Medical University.'}, {'ForeName': 'Xiaolin', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Department of Cardiology, Thoracic Clinical College, Tianjin Medical University, Tianjin, China.'}, {'ForeName': 'Yin', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Cardiology, Tianjin Chest Hospital.'}]",Medicine,['10.1097/MD.0000000000020152'] 2027,32590758,"Efficacy of deep convolutional neural network algorithm for the identification and classification of dental implant systems, using panoramic and periapical radiographs: A pilot study.","Convolutional neural networks (CNNs), a particular type of deep learning architecture, are positioned to become one of the most transformative technologies for medical applications. The aim of the current study was to evaluate the efficacy of deep CNN algorithm for the identification and classification of dental implant systems.A total of 5390 panoramic and 5380 periapical radiographic images from 3 types of dental implant systems, with similar shape and internal conical connection, were randomly divided into training and validation dataset (80%) and a test dataset (20%). We performed image preprocessing and transfer learning techniques, based on fine-tuned and pre-trained deep CNN architecture (GoogLeNet Inception-v3). The test dataset was used to assess the accuracy, sensitivity, specificity, receiver operating characteristic curve, area under the receiver operating characteristic curve (AUC), and confusion matrix compared between deep CNN and periodontal specialist.We found that the deep CNN architecture (AUC = 0.971, 95% confidence interval 0.963-0.978) and board-certified periodontist (AUC = 0.925, 95% confidence interval 0.913-0.935) showed reliable classification accuracies.This study demonstrated that deep CNN architecture is useful for the identification and classification of dental implant systems using panoramic and periapical radiographic images.",2020,"We found that the deep CNN architecture (AUC = 0.971, 95% confidence interval 0.963-0.978) and board-certified periodontist (AUC = 0.925, 95% confidence interval 0.913-0.935) showed reliable classification accuracies.","['A total of 5390 panoramic and 5380 periapical radiographic images from 3 types of dental implant systems, with similar shape and internal conical connection']","['Convolutional neural networks (CNNs', 'deep CNN algorithm', 'deep convolutional neural network algorithm']","['accuracy, sensitivity, specificity, receiver operating characteristic curve, area under the receiver operating characteristic curve (AUC), and confusion matrix']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0729269', 'cui_str': 'Periapical'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C3880579', 'cui_str': 'Dental implant system'}, {'cui': 'C0332479', 'cui_str': 'Shape finding'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0449379', 'cui_str': 'Connection'}]","[{'cui': 'C0242406', 'cui_str': 'Neural Networks (Anatomic)'}, {'cui': 'C0205125', 'cui_str': 'Deep'}]","[{'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0037791', 'cui_str': 'Specificity'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0034772', 'cui_str': 'Receiver Operating Characteristic'}, {'cui': 'C0009676', 'cui_str': 'Confusional state'}, {'cui': 'C4050026', 'cui_str': 'Matrix'}]",5390.0,0.0265642,"We found that the deep CNN architecture (AUC = 0.971, 95% confidence interval 0.963-0.978) and board-certified periodontist (AUC = 0.925, 95% confidence interval 0.913-0.935) showed reliable classification accuracies.","[{'ForeName': 'Jae-Hong', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': ''}, {'ForeName': 'Seong-Nyum', 'Initials': 'SN', 'LastName': 'Jeong', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000020787'] 2028,32590780,Evaluation of rehabilitation effect of five-step exercises on patients with radiculopathy of cervical vertebra.,"BACKGROUND Among all types of cervical spondylitis, cervical spondylitis radiculopathy (CSR) has the highest incidence. The incidence of CSR increases year by year and is generally younger, which has seriously threatened people's quality of life and affected their work and life. This study proposes to improve the recovery rate of patients with CSR, delay the recurrence, improve the symptoms of patients, and improve the quality of life of patients through the rehabilitation and exercise of five-step cervical vertebra exercises. METHODS For 90 patients with CSR that met the inclusion criteria, SPSS 23.0 software random number generator was used to randomly divide the patients into an experimental group and control group, with 45 cases in each group. The control group took basic nursing measures, and the experimental group took five steps of cervical vertebra rehabilitation exercises on the basis of elementary nursing measures. The rehabilitation effect of five-step exercises on CSR patients was evaluated by Neck Disability Index (NDI), Visual Analogue Scale (VAS), and Cervical range of motion measured (CROM) before and after intervention. RESULTS The results of this trial will be published on the website of China Clinical Trial Registration Center (http://www.chictr.org.cn/searchproj.aspx) and in peer-reviewed journals or academic conferences. CONCLUSIONS This study will examine the feasibility and preliminary effects of five-step exercises for the treatment of patients with CSR. TRIAL REGISTRATION This protocol was registered in Clinical Trials platform with the number ChiCTR1900027299.",2020,"The incidence of CSR increases year by year and is generally younger, which has seriously threatened people's quality of life and affected their work and life.","['90 patients with CSR', 'patients with radiculopathy of cervical vertebra', 'patients with CSR']","['control group took basic nursing measures, and the experimental group took five steps of cervical vertebra rehabilitation exercises', 'five-step exercises']","['recovery rate', 'Neck Disability Index (NDI), Visual Analogue Scale (VAS), and Cervical range of motion measured (CROM']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0263854', 'cui_str': 'Cervical arthritis'}, {'cui': 'C0700594', 'cui_str': 'Radiculopathy'}, {'cui': 'C3665420', 'cui_str': 'Bone structure of cervical vertebra'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C3665420', 'cui_str': 'Bone structure of cervical vertebra'}, {'cui': 'C0452240', 'cui_str': 'Exercises'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",90.0,0.0298168,"The incidence of CSR increases year by year and is generally younger, which has seriously threatened people's quality of life and affected their work and life.","[{'ForeName': 'Xia', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': 'Gansu Provincial Hospital of Traditional Chinese Medicine.'}, {'ForeName': 'Yajie', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Gansu University of Chinese Medicine.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Yang', 'Affiliation': 'Gansu University of Chinese Medicine.'}, {'ForeName': 'Xinyu', 'Initials': 'X', 'LastName': 'Song', 'Affiliation': 'Gansu University of Chinese Medicine.'}, {'ForeName': 'Zhilong', 'Initials': 'Z', 'LastName': 'Chen', 'Affiliation': 'Gansu Provincial Hospital of Traditional Chinese Medicine.'}, {'ForeName': 'Lingge', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': 'Gansu Provincial Hospital of Traditional Chinese Medicine.'}, {'ForeName': 'Yaxin', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Lanzhou University, Lanzhou, Gansu, China.'}]",Medicine,['10.1097/MD.0000000000020846'] 2029,32590979,"Simulation-based low-dose, high-frequency plus mobile mentoring versus traditional group-based trainings among health workers on day of birth care in Nigeria; a cluster randomized controlled trial.","BACKGROUND The aim of this study was to compare health workers knowledge and skills competencies between those trained using the onsite simulation-based, low-dose, high frequency training plus mobile mentoring (LDHF/m-mentoring) and the ones trained through traditional offsite, group-based training (TRAD) approach in Kogi and Ebonyi states, Nigeria, over a 12-month period. METHODS A prospective cluster randomized controlled trial was conducted by enrolling 299 health workers who provided healthcare to mothers and their babies on the day of birth in 60 health facilities in Kogi and Ebonyi states. These were randomized to either LDHF/m-mentoring (intervention, n = 30 facilities) or traditional group-based training (control, n = 30 facilities) control arm. They received Basic Emergency Obstetrics and Newborn Care (BEmONC) training with simulated practice using anatomic models and role-plays. The control arm was trained offsite while the intervention arm was trained onsite where they worked. Mentorship was done through telephone calls and reminder text messages. The multiple choice questions (MCQs) and objective structured clinical examinations (OSCEs) mean scores were compared; p-value < 0.05 was considered statistically significant. Qualitative data were also collected and content analysis was conducted. RESULTS The mean knowledge scores between the two arms at months 3 and 12 post-training were equally high; no statistically significant differences. Both arms showed improvements in composite scores for assessed BEmONC clinical skills from around 30% at baseline to 75% and above at end line (p < 0.05). Overall, the observed improvement and retention of skills was higher in intervention arm compared to the control arm at 12 months post-training, (p < 0.05). Some LDHF/m-mentoring approach trainees reported that mentors' support improved their acquisition and maintenance of knowledge and skills, which may have led to reductions in maternal and newborn deaths in their facilities. CONCLUSION The LDHF/m-mentoring intervention is more effective than TRAD approach in improving health workers' skills acquisition and retention. Health care managers should have the option to select the LDHF/m-mentoring learning approach, depending on their country's priorities or context, as it ensures health workers remain in their place of work during training events thus less disruption to service delivery. TRIAL REGISTRATION The trial was retrospectively registered on August 24, 2017 at ClinicalTrials.Gov: NCT03269240.",2020,The LDHF/m-mentoring intervention is more effective than TRAD approach in improving health workers' skills acquisition and retention.,"['health workers on day of birth care in Nigeria', 'enrolling 299 health workers who provided healthcare to mothers and their babies on the day of birth in 60 health facilities in Kogi and Ebonyi states']","['frequency training plus mobile mentoring (LDHF/m-mentoring) and the ones trained through traditional offsite, group-based training (TRAD) approach in Kogi and Ebonyi states, Nigeria, over a 12-month period', 'Simulation-based low-dose, high-frequency plus mobile mentoring versus traditional group-based trainings', 'Basic Emergency Obstetrics and Newborn Care (BEmONC) training with simulated practice using anatomic models and role-plays', 'LDHF/m-mentoring (intervention, n\u2009=\u200930 facilities) or traditional group-based training (control, n\u2009=\u200930 facilities) control arm']","['multiple choice questions (MCQs) and objective structured clinical examinations (OSCEs) mean scores', 'retention of skills', 'mean knowledge scores', 'composite scores']","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0028075', 'cui_str': 'Nigeria'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C1301808', 'cui_str': 'State'}]","[{'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0025369', 'cui_str': 'Mentors'}, {'cui': 'C0205447', 'cui_str': '1'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0028075', 'cui_str': 'Nigeria'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0205212', 'cui_str': 'High frequency'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C0204792', 'cui_str': 'Routine care of newborn'}, {'cui': 'C0026337', 'cui_str': 'Anatomic Models'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]","[{'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0205199', 'cui_str': 'Composite'}]",299.0,0.125709,The LDHF/m-mentoring intervention is more effective than TRAD approach in improving health workers' skills acquisition and retention.,"[{'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Ugwa', 'Affiliation': ""USAID's Maternal and Child Survival Program/Jhpiego, Nigeria, 971 Reuben Okoya Crescent, Wuye District, Abuja, Nigeria. drajulugreatgod@hotmail.co.za.""}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Kabue', 'Affiliation': ""USAID's Maternal and Child Survival Program/Jhpiego-, 1615 Thames St, Baltimore, MD, 21231, USA.""}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Otolorin', 'Affiliation': ""USAID's Maternal and Child Survival Program/Jhpiego, Nigeria, 971 Reuben Okoya Crescent, Wuye District, Abuja, Nigeria.""}, {'ForeName': 'Gayane', 'Initials': 'G', 'LastName': 'Yenokyan', 'Affiliation': 'The Johns Hopkins Biostatistics Center, Johns Hopkins Bloomberg School of Public Health, 615 N. Wolfe Street, Baltimore, MD, USA.'}, {'ForeName': 'Adetiloye', 'Initials': 'A', 'LastName': 'Oniyire', 'Affiliation': ""USAID's Maternal and Child Survival Program/Jhpiego, Nigeria, 971 Reuben Okoya Crescent, Wuye District, Abuja, Nigeria.""}, {'ForeName': 'Bright', 'Initials': 'B', 'LastName': 'Orji', 'Affiliation': ""USAID's Maternal and Child Survival Program/Jhpiego, Nigeria, 971 Reuben Okoya Crescent, Wuye District, Abuja, Nigeria.""}, {'ForeName': 'Ugo', 'Initials': 'U', 'LastName': 'Okoli', 'Affiliation': ""USAID's Maternal and Child Survival Program/Jhpiego, Nigeria, 971 Reuben Okoya Crescent, Wuye District, Abuja, Nigeria.""}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Enne', 'Affiliation': ""USAID's Maternal and Child Survival Program/Jhpiego, Nigeria, 971 Reuben Okoya Crescent, Wuye District, Abuja, Nigeria.""}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Alobo', 'Affiliation': ""USAID's Maternal and Child Survival Program/Jhpiego, Nigeria, 971 Reuben Okoya Crescent, Wuye District, Abuja, Nigeria.""}, {'ForeName': 'Gladys', 'Initials': 'G', 'LastName': 'Olisaekee', 'Affiliation': ""USAID's Maternal and Child Survival Program/Jhpiego, Nigeria, 971 Reuben Okoya Crescent, Wuye District, Abuja, Nigeria.""}, {'ForeName': 'Adebayo', 'Initials': 'A', 'LastName': 'Oluwatobi', 'Affiliation': ""USAID's Maternal and Child Survival Program/Jhpiego, Nigeria, 971 Reuben Okoya Crescent, Wuye District, Abuja, Nigeria.""}, {'ForeName': 'Chioma', 'Initials': 'C', 'LastName': 'Oduenyi', 'Affiliation': ""USAID's Maternal and Child Survival Program/Jhpiego, Nigeria, 971 Reuben Okoya Crescent, Wuye District, Abuja, Nigeria.""}, {'ForeName': 'Adekunle', 'Initials': 'A', 'LastName': 'Aledare', 'Affiliation': 'Department of Public Health, State Ministry of Health, Lokoja, Kogi State, Nigeria.'}, {'ForeName': 'Boniface', 'Initials': 'B', 'LastName': 'Onwe', 'Affiliation': 'Department of Public Health, State Ministry of Health, Abakiliki, Ebonyi State, Nigeria.'}, {'ForeName': 'Gbenga', 'Initials': 'G', 'LastName': 'Ishola', 'Affiliation': ""USAID's Maternal and Child Survival Program/Jhpiego, Nigeria, 971 Reuben Okoya Crescent, Wuye District, Abuja, Nigeria.""}]",BMC health services research,['10.1186/s12913-020-05450-9'] 2030,32591004,Study design of the DAS-OLT trial: a randomized controlled trial to evaluate the impact of dexmedetomidine on early allograft dysfunction following liver transplantation.,"BACKGROUND Perioperative ischemia/reperfusion (I/R) injury during liver transplantation is strongly associated with early allograft dysfunction (EAD), graft loss, and mortality. Hepatic I/R injury also causes remote damage to other organs including the renal and pulmonary systems. Dexmedetomidine (DEX), a selective α2-adrenoceptor agonist which is used as an adjuvant to general anesthesia, has been shown in preclinical studies to provide organ protection by ameliorating the effects of I/R injury in a range of tissues (including the liver). However, prospective clinical evidence of any potential benefits in improving outcomes in liver transplantation is lacking. This study aimed to verify the hypothesis that the application of dexmedetomidine during the perioperative period of liver transplantation can reduce the incidence of EAD and primary graft non-function (PNF). At the same time, the effects of dexmedetomidine application on perioperative renal function and lung function were studied. METHODS This is a prospective, single-center, randomized, parallel-group study. Two hundred participants (18-65 years) scheduled to undergo liver transplantation under general anesthesia will be included in this study. For participants in the treatment group, a loading dose of DEX will be given after induction of anesthesia (1 μg/kg over 10 min) followed by a continuous infusion (0.5 μg/kg /h) until the end of surgery. For participants in the placebo group, an equal volume loading dose of 0.9% saline will be given after the induction of anesthesia followed by an equal volume continuous infusion until the end of surgery. All other supplements, e.g., opioids, sedatives, and muscle relaxant, will be identical in both arms and administered according to routine clinical practice. DISCUSSION The present trial will examine whether DEX confers organoprotective effects in the liver, in terms of reducing the incidence of EAD and PNF in orthotopic liver transplantation recipients. TRIAL REGISTRATION ClinicalTrials.gov NCT03770130. Registered on 10 December 2018. https://clinicaltrials.gov/ct2/show/NCT03770130.",2020,"The present trial will examine whether DEX confers organoprotective effects in the liver, in terms of reducing the incidence of EAD and PNF in orthotopic liver transplantation recipients. ","['Two hundred participants (18-65\u2009years) scheduled to undergo liver transplantation under general anesthesia will be included in this study', 'liver transplantation', 'orthotopic liver transplantation recipients']","['placebo', 'dexmedetomidine', 'Dexmedetomidine (DEX', 'DEX']","['incidence of EAD and primary graft non-function (PNF', 'perioperative renal function and lung function', 'early allograft dysfunction (EAD), graft loss, and mortality', 'early allograft dysfunction']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0023911', 'cui_str': 'Transplantation of liver'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0400447', 'cui_str': 'Orthotopic liver transplant'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0040739', 'cui_str': 'Allogeneic transplantation'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0877042', 'cui_str': 'Graft loss'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",200.0,0.207344,"The present trial will examine whether DEX confers organoprotective effects in the liver, in terms of reducing the incidence of EAD and PNF in orthotopic liver transplantation recipients. ","[{'ForeName': 'Chenlu', 'Initials': 'C', 'LastName': 'Ni', 'Affiliation': 'Department of Anesthesiology, Ren Ji Hospital, Shanghai Jiao Tong University School of Medicine, No. 160 Pujian Road, Shanghai, 200127, China.'}, {'ForeName': 'Joe', 'Initials': 'J', 'LastName': 'Masters', 'Affiliation': 'Anaesthetics, Pain Medicine and Intensive Care, Department of Surgery and Cancer, Faculty of Medicine, Imperial College London, Chelsea and Westminster Hospital, London, UK.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Zhu', 'Affiliation': 'Department of Anesthesiology, Ren Ji Hospital, Shanghai Jiao Tong University School of Medicine, No. 160 Pujian Road, Shanghai, 200127, China.'}, {'ForeName': 'Weifeng', 'Initials': 'W', 'LastName': 'Yu', 'Affiliation': 'Department of Anesthesiology, Ren Ji Hospital, Shanghai Jiao Tong University School of Medicine, No. 160 Pujian Road, Shanghai, 200127, China.'}, {'ForeName': 'Yingfu', 'Initials': 'Y', 'LastName': 'Jiao', 'Affiliation': 'Department of Anesthesiology, Ren Ji Hospital, Shanghai Jiao Tong University School of Medicine, No. 160 Pujian Road, Shanghai, 200127, China.'}, {'ForeName': 'Yuting', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Department of Anesthesiology, Ren Ji Hospital, Shanghai Jiao Tong University School of Medicine, No. 160 Pujian Road, Shanghai, 200127, China.'}, {'ForeName': 'Cui', 'Initials': 'C', 'LastName': 'Cui', 'Affiliation': 'Department of Anesthesiology, Ren Ji Hospital, Shanghai Jiao Tong University School of Medicine, No. 160 Pujian Road, Shanghai, 200127, China.'}, {'ForeName': 'Suqing', 'Initials': 'S', 'LastName': 'Yin', 'Affiliation': 'Department of Anesthesiology, Ren Ji Hospital, Shanghai Jiao Tong University School of Medicine, No. 160 Pujian Road, Shanghai, 200127, China.'}, {'ForeName': 'Liqun', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': 'Department of Anesthesiology, Ren Ji Hospital, Shanghai Jiao Tong University School of Medicine, No. 160 Pujian Road, Shanghai, 200127, China. lqyang72721@126.com.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Qi', 'Affiliation': 'Department of Anesthesiology, Ren Ji Hospital, Shanghai Jiao Tong University School of Medicine, No. 160 Pujian Road, Shanghai, 200127, China. renji_qibo@foxmail.com.'}, {'ForeName': 'Daqing', 'Initials': 'D', 'LastName': 'Ma', 'Affiliation': 'Anaesthetics, Pain Medicine and Intensive Care, Department of Surgery and Cancer, Faculty of Medicine, Imperial College London, Chelsea and Westminster Hospital, London, UK.'}]",Trials,['10.1186/s13063-020-04497-7'] 2031,32591007,INdividual Vocational and Educational Support Trial (INVEST) for young people with borderline personality disorder: study protocol for a randomised controlled trial.,"BACKGROUND The clinical onset of borderline personality disorder (BPD) usually occurs in young people (aged 12-25 years) and commonly leads to difficulty achieving and maintaining vocational (education and/or employment) engagement. While current psychosocial interventions lead to improvements in psychopathology, they have little effect upon functioning. Individual Placement and Support (IPS) is a client-driven model that assists individuals with severe mental illness to engage with education and/or employment appropriate to their personal goals, and that provides ongoing support to maintain this engagement. The objective of the INdividual Vocational and Educational Support Trial (INVEST) is to evaluate the effectiveness of adding IPS to an evidence-based early intervention programme for BPD, with the aim of improving vocational outcomes. METHODS/DESIGN INVEST is a single-blind, parallel-groups, randomised controlled trial (RCT). The randomisation is stratified by gender and age and uses random permuted blocks. The interventions are 39 weeks of either IPS, or 'usual vocational services' (UVS). Participants will comprise 108 help-seeking young people (aged 15-25 years) with three or more DSM-5 BPD features and a desire to study or work, recruited from the Helping Young People Early (HYPE) early intervention programme for BPD at Orygen, in Melbourne, Australia. All participants will receive the HYPE intervention. After baseline assessment, staff who are blind to the intervention group allocation will conduct assessments at 13, 26, 39 and 52 weeks. At the 52-week primary endpoint, the primary outcome is the number of days in mainstream education/employment since baseline. Secondary outcomes include the cost-effectiveness of the intervention, quality of life, and BPD severity. DISCUSSION Current treatments for BPD have little impact on vocational outcomes and enduring functional impairment is prevalent among this patient group. IPS is a targeted functional intervention, which has proven effective in improving vocational outcomes for adults and young people with psychotic disorders. This trial will investigate whether IPS is effective for improving vocational (employment and educational) outcomes among young people with subthreshold or full-syndrome BPD. TRIAL REGISTRATION Australian New Zealand Clinical Trials Registry, ID: ACTRN12619001220156 . 13 September 2019.",2020,"IPS is a targeted functional intervention, which has proven effective in improving vocational outcomes for adults and young people with psychotic disorders.","['adults and young people with psychotic disorders', 'Participants will comprise 108 help-seeking young people (aged 15-25\u2009years) with three or more DSM-5 BPD features and a desire to study or work, recruited from the Helping Young People Early (HYPE) early intervention programme for BPD at Orygen, in Melbourne, Australia', 'young people (aged 12-25\u2009years', 'young people with borderline personality disorder', 'young people with subthreshold or full-syndrome BPD', 'individuals with severe mental illness']","['INdividual Vocational and Educational Support Trial (INVEST', 'Individual Placement and Support (IPS', 'HYPE intervention', 'IPS', ""IPS, or 'usual vocational services' (UVS""]","['cost-effectiveness of the intervention, quality of life, and BPD severity', 'number of days in mainstream education/employment since baseline']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}, {'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1137105', 'cui_str': 'DSM-V'}, {'cui': 'C0006012', 'cui_str': 'Borderline personality disorder'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0242687', 'cui_str': 'Provision of early intervention service for child'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}]","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C4750554', 'cui_str': 'Individual Placement and Support'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0242687', 'cui_str': 'Provision of early intervention service for child'}, {'cui': 'C0557854', 'cui_str': 'Services'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0006012', 'cui_str': 'Borderline personality disorder'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0024500', 'cui_str': 'Mainstreaming (Education)'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0014003', 'cui_str': 'Employment'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]",,0.130796,"IPS is a targeted functional intervention, which has proven effective in improving vocational outcomes for adults and young people with psychotic disorders.","[{'ForeName': 'Andrew M', 'Initials': 'AM', 'LastName': 'Chanen', 'Affiliation': 'Orygen, 35 Poplar Road, Parkville, Melbourne, VIC, 3052, Australia. andrew.chanen@orygen.org.au.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Nicol', 'Affiliation': 'Orygen, 35 Poplar Road, Parkville, Melbourne, VIC, 3052, Australia.'}, {'ForeName': 'Jennifer K', 'Initials': 'JK', 'LastName': 'Betts', 'Affiliation': 'Orygen, 35 Poplar Road, Parkville, Melbourne, VIC, 3052, Australia.'}, {'ForeName': 'Gary R', 'Initials': 'GR', 'LastName': 'Bond', 'Affiliation': 'IPS Employment Center, Rockville Institute and Westat Inc., 85 Mechanic Street, Suite C3-1, Box 4A, Lebanon, NH, 03766, USA.'}, {'ForeName': 'Cathrine', 'Initials': 'C', 'LastName': 'Mihalopoulos', 'Affiliation': 'Deakin Health Economics, Centre for Population Health Research, Deakin University, Geelong, VIC, 3220, Australia.'}, {'ForeName': 'Henry J', 'Initials': 'HJ', 'LastName': 'Jackson', 'Affiliation': 'Melbourne School of Psychological Sciences, Redmond Barry Building, The University of Melbourne, Parkville, Melbourne, VIC, 3010, Australia.'}, {'ForeName': 'Katherine N', 'Initials': 'KN', 'LastName': 'Thompson', 'Affiliation': 'Orygen, 35 Poplar Road, Parkville, Melbourne, VIC, 3052, Australia.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Jovev', 'Affiliation': 'Orygen, 35 Poplar Road, Parkville, Melbourne, VIC, 3052, Australia.'}, {'ForeName': 'Hok Pan', 'Initials': 'HP', 'LastName': 'Yuen', 'Affiliation': 'Orygen, 35 Poplar Road, Parkville, Melbourne, VIC, 3052, Australia.'}, {'ForeName': 'Gina', 'Initials': 'G', 'LastName': 'Chinnery', 'Affiliation': 'Orygen, 35 Poplar Road, Parkville, Melbourne, VIC, 3052, Australia.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Ring', 'Affiliation': 'Travancore School, 35 Poplar Road, Parkville, Melbourne, VIC, 3052, Australia.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Allott', 'Affiliation': 'Orygen, 35 Poplar Road, Parkville, Melbourne, VIC, 3052, Australia.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'McCutcheon', 'Affiliation': 'Orygen, 35 Poplar Road, Parkville, Melbourne, VIC, 3052, Australia.'}, {'ForeName': 'Ashleigh P', 'Initials': 'AP', 'LastName': 'Salmon', 'Affiliation': 'Orygen, 35 Poplar Road, Parkville, Melbourne, VIC, 3052, Australia.'}, {'ForeName': 'Eoin', 'Initials': 'E', 'LastName': 'Killackey', 'Affiliation': 'Orygen, 35 Poplar Road, Parkville, Melbourne, VIC, 3052, Australia.'}]",Trials,['10.1186/s13063-020-04471-3'] 2032,32591421,"A Single Load of Fructose Attenuates the Risk of Exercise-Induced Hypoglycemia in Adults With Type 1 Diabetes on Ultra-Long-Acting Basal Insulin: A Randomized, Open-Label, Crossover Proof-of-Principle Study.","OBJECTIVE While the adjustment of insulin is an established strategy to reduce the risk of exercise-associated hypoglycemia for individuals with type 1 diabetes, it is not easily feasible for those treated with ultra-long-acting basal insulin. The current study determined whether pre-exercise intake of fructose attenuates the risk of exercise-induced hypoglycemia in individuals with type 1 diabetes using insulin degludec. RESEARCH DESIGN AND METHODS Fourteen male adults with type 1 diabetes completed two 60-min aerobic cycling sessions with or without prior intake (30 min) of 20 g of fructose, in a randomized two-period crossover design. Exercise was performed in the morning in a fasted state without prior insulin reduction and after 48 h of standardized diet. The primary outcome was time to hypoglycemia (plasma glucose ≤3.9 mmol/L) during exercise. RESULTS Intake of fructose resulted in one hypoglycemic event at 60 min compared with six hypoglycemic events at 27.5 ± 9.4 min of exercise in the control condition, translating into a risk reduction of 87.8% (hazard ratio 0.12 [95% CI 0.02, 0.66]; P = 0.015). Mean plasma glucose during exercise was 7.3 ± 1.4 mmol/L with fructose and 5.5 ± 1.1 mmol/L in the control group ( P < 0.001). Lactate levels were higher at rest in the 30 min following fructose intake ( P < 0.001) but were not significantly different from the control group during exercise ( P = 0.32). Substrate oxidation during exercise did not significantly differ between the conditions ( P = 0.73 for carbohydrate and P = 0.48 for fat oxidation). Fructose was well tolerated. CONCLUSIONS Pre-exercise intake of fructose is an easily feasible, effective, and well-tolerated strategy to alleviate the risk of exercise-induced hypoglycemia while avoiding hyperglycemia in individuals with type 1 diabetes on ultra-long-acting insulin.",2020,Substrate oxidation during exercise did not significantly differ between the conditions ( P = 0.73 for carbohydrate and P = 0.48 for fat oxidation).,"['Adults With Type 1 Diabetes on Ultra-Long-Acting Basal Insulin', 'individuals with type 1 diabetes using insulin degludec', 'Fourteen male adults with type 1 diabetes', 'individuals with type 1 diabetes']","['Fructose', '60-min aerobic cycling sessions with or without prior intake (30 min) of 20 g of fructose']","['Lactate levels', 'Mean plasma glucose', 'tolerated', 'hypoglycemic event', 'time to hypoglycemia (plasma glucose ≤3.9 mmol/L) during exercise', 'Substrate oxidation during exercise']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0240016', 'cui_str': 'Insulin used'}, {'cui': 'C3491971', 'cui_str': 'insulin degludec'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0016745', 'cui_str': 'Fructose'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0450403', 'cui_str': '20G'}]","[{'cui': 'C0428445', 'cui_str': 'D-lactate measurement'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma'}, {'cui': 'C0020616', 'cui_str': 'Hypoglycemic agent'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C1532563', 'cui_str': 'mmol/L'}, {'cui': 'C0587107', 'cui_str': 'During exercise'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}]",14.0,0.0650296,Substrate oxidation during exercise did not significantly differ between the conditions ( P = 0.73 for carbohydrate and P = 0.48 for fat oxidation).,"[{'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Kosinski', 'Affiliation': 'Department of Diabetes, Endocrinology, Nutritional Medicine and Metabolism, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Herzig', 'Affiliation': 'Department of Diabetes, Endocrinology, Nutritional Medicine and Metabolism, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Céline Isabelle', 'Initials': 'CI', 'LastName': 'Laesser', 'Affiliation': 'Department of Diabetes, Endocrinology, Nutritional Medicine and Metabolism, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Christos T', 'Initials': 'CT', 'LastName': 'Nakas', 'Affiliation': 'Laboratory of Biometry, School of Agriculture, University of Thessaly, Nea Ionia Magnesia, Greece.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Melmer', 'Affiliation': 'Department of Diabetes, Endocrinology, Nutritional Medicine and Metabolism, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Vogt', 'Affiliation': 'Department of Anaesthesiology and Pain Medicine, Inselspital, Bern University Hospital, University of Bern, Switzerland.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Vogt', 'Affiliation': 'Department of Nephrology and Hypertension, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Laimer', 'Affiliation': 'Department of Diabetes, Endocrinology, Nutritional Medicine and Metabolism, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Lia', 'Initials': 'L', 'LastName': 'Bally', 'Affiliation': 'Department of Diabetes, Endocrinology, Nutritional Medicine and Metabolism, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Stettler', 'Affiliation': 'Department of Diabetes, Endocrinology, Nutritional Medicine and Metabolism, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland christoph.stettler@insel.ch.'}]",Diabetes care,['10.2337/dc19-2250'] 2033,32592261,Acute performance and physiological responses to repeated-sprint exercise in a combined hot and hypoxic environment.,"We investigated performance, energy metabolism, acid-base balance, and endocrine responses to repeated-sprint exercise in hot and/or hypoxic environment. In a single-blind, cross-over study, 10 male highly trained athletes completed a repeated cycle sprint exercise (3 sets of 3 × 10-s maximal sprints with 40-s passive recovery) under four conditions (control [CON; 20℃, 50% rH, FiO 2 : 20.9%; sea level], hypoxia [HYP; 20℃, 50% rH, FiO 2 : 14.5%; a simulated altitude of 3,000 m], hot [HOT; 35℃, 50% rH, FiO 2 : 20.9%; sea level], and hot + hypoxia [HH; 35℃, 50% rH, FiO 2 : 14.5%; a simulated altitude of 3,000 m]). Changes in power output, muscle and skin temperatures, and respiratory oxygen uptake were measured. Peak (CON: 912 ± 26 W, 95% confidence interval [CI]: 862-962 W, HYP: 915 ± 28 W [CI: 860-970 W], HOT: 937 ± 26 W [CI: 887-987 W], HH: 937 ± 26 W [CI: 886-987 W]) and mean (CON: 808 ± 22 W [CI: 765-851 W], HYP: 810 ± 23 W [CI: 765-855 W], HOT: 825 ± 22 W [CI: 781-868 W], HH: 824 ± 25 W [CI: 776-873 W]) power outputs were significantly greater when exercising in heat conditions (HOT and HH) during the first sprint (p < .05). Heat exposure (HOT and HH) elevated muscle and skin temperatures compared to other conditions (p < .05). Oxygen uptake and arterial oxygen saturation were significantly lower in hypoxic conditions (HYP and HH) versus the other conditions (p < .05). In summary, additional heat stress when sprinting repeatedly in hypoxia improved performance (early during exercise), while maintaining low arterial oxygen saturation.",2020,25 W [CI: 776-873 W]) power outputs were significantly greater when exercising in heat conditions (HOT and HH) during the first sprint (p < .05).,"['22', '10 male highly trained athletes completed a', 'hot and/or hypoxic environment', '26']","['repeated cycle sprint exercise', 'repeated-sprint exercise']","['Heat exposure (HOT and HH) elevated muscle and skin temperatures', 'low arterial oxygen saturation', 'performance, energy metabolism, acid-base balance, and endocrine responses', 'power output, muscle and skin temperatures, and respiratory oxygen uptake', 'Oxygen uptake and arterial oxygen saturation']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0444519', 'cui_str': 'Hot'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0014406', 'cui_str': 'Environment'}]","[{'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0239930', 'cui_str': 'Heat exposure'}, {'cui': 'C0444519', 'cui_str': 'Hot'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0037294', 'cui_str': 'Temperature of skin'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0428175', 'cui_str': 'Oxygen saturation measurement, arterial'}, {'cui': 'C0014272', 'cui_str': 'Energy expenditure'}, {'cui': 'C0001117', 'cui_str': 'Acid-base equilibrium'}, {'cui': 'C0014136', 'cui_str': 'Structure of endocrine system'}, {'cui': 'C0445194', 'cui_str': 'Power output'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}]",10.0,0.0615615,25 W [CI: 776-873 W]) power outputs were significantly greater when exercising in heat conditions (HOT and HH) during the first sprint (p < .05).,"[{'ForeName': 'Keiichi', 'Initials': 'K', 'LastName': 'Yamaguchi', 'Affiliation': 'Graduate School of Sport and Health Science, Ritsumeikan University, Kusatsu, Shiga, Japan.'}, {'ForeName': 'Nobukazu', 'Initials': 'N', 'LastName': 'Kasai', 'Affiliation': 'Graduate School of Sport and Health Science, Ritsumeikan University, Kusatsu, Shiga, Japan.'}, {'ForeName': 'Nanako', 'Initials': 'N', 'LastName': 'Hayashi', 'Affiliation': 'Graduate School of Sport and Health Science, Ritsumeikan University, Kusatsu, Shiga, Japan.'}, {'ForeName': 'Haruka', 'Initials': 'H', 'LastName': 'Yatsutani', 'Affiliation': 'Graduate School of Sport and Health Science, Ritsumeikan University, Kusatsu, Shiga, Japan.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Girard', 'Affiliation': 'School of Human Science (Exercise and Sport Science), The University of Western Australia, Crawley, Australia.'}, {'ForeName': 'Kazushige', 'Initials': 'K', 'LastName': 'Goto', 'Affiliation': 'Graduate School of Sport and Health Science, Ritsumeikan University, Kusatsu, Shiga, Japan.'}]",Physiological reports,['10.14814/phy2.14466'] 2034,32592439,Preventing Stress-Related Ill Health Among New Registered Nurses by Supporting Engagement in Proactive Behaviors-A Randomized Controlled Trial.,"BACKGROUND New registered nurses (RNs) are at risk of developing symptoms of stress-related ill health. OBJECTIVES To evaluate the effect of a 3 × 3 hour group intervention aiming to prevent symptoms of stress-related ill health among new RNs by increasing engagement in proactive behaviors. The intervention involves discussions and models of newcomer experiences and stress and the behavior change techniques reinforcing approach behaviors, systematic exposure, and action planning. DESIGN A randomized parallel group trial with an active control condition. PARTICIPANTS The study sample consisted of 239 new RNs participating in a transition-to-practice program for new RNs in a large county in Sweden. METHODS Participants were randomized to either the experimental intervention or a control intervention. Data on experiences of stress, avoidance of proactive behaviors, engagement in leisure activities, role clarity, task mastery, and social acceptance were collected before and after the intervention. Effects were evaluated using multilevel model analysis and regression analysis. Missing data were imputed using multiple imputation. RESULTS The control group experienced a statistically significant increase in experiences of stress during the period of the study (t(194.13) = 1.98, p = .049), whereas the level in the experimental group remained stable. Greater adherence to the intervention predicted a greater effect on experiences of stress (β = -0.15, p = .039) and social acceptance (β = 0.16, p = .027). LINKING EVIDENCE TO ACTION Transition-to-practice programs may benefit from adding an intervention that specifically addresses new RNs' experiences of stress to further support them as they adjust to their new professional role. However, replication studies with larger samples, more reliable measures, and longer periods of follow-up are needed.",2020,"Greater adherence to the intervention predicted a greater effect on experiences of stress (β = -0.15, p = .039) and social acceptance (β = 0.16, p = .027). ","['The study sample consisted of 239 new RNs participating in a transition-to-practice program for new RNs in a large county in Sweden', 'Participants']",['control intervention'],"['experiences of stress', 'stress, avoidance of proactive behaviors, engagement in leisure activities, role clarity, task mastery, and social acceptance', 'social acceptance']","[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0687673', 'cui_str': 'Registered nurse'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0023292', 'cui_str': 'Leisure Activities'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0486588', 'cui_str': 'Clarity (property)'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}]",,0.0564245,"Greater adherence to the intervention predicted a greater effect on experiences of stress (β = -0.15, p = .039) and social acceptance (β = 0.16, p = .027). ","[{'ForeName': 'Elin', 'Initials': 'E', 'LastName': 'Frögéli', 'Affiliation': 'Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Rudman', 'Affiliation': 'Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Brjánn', 'Initials': 'B', 'LastName': 'Ljótsson', 'Affiliation': 'Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Petter', 'Initials': 'P', 'LastName': 'Gustavsson', 'Affiliation': 'Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden.'}]",Worldviews on evidence-based nursing,['10.1111/wvn.12442'] 2035,32473928,Short-term interval exercise suppresses acylated ghrelin and hunger during caloric restriction in women with obesity.,"Caloric restriction is suggested to increase hunger, in part, through complex interactions of hormones and behavior that contribute to challenges in long-term weight loss. Although intense exercise may attenuate appetite, no data exist testing the effects of interval exercise (INT) during a low-calorie diet (LCD) on appetite regulation. We hypothesized that LCD+INT would favorably influence satiety when compared with an energy-deficit matched LCD in women with obesity. Twenty-six women with obesity (47.3±2.4 yrs; 37.3 ± 1.2 kg/m 2 ) were randomized to either LCD (n = 13; mixed meals of ~1200 kcal/d) or LCD+INT (n = 13; 60 min/d of supervised interval exercise at 90% HRpeak for 3 min and 50% HRpeak for 3 min) for 2 weeks. An additional 350kcal (shake) was provided to LCD+INT individuals post-exercise to equate energy availability between groups. Total PYY, acylated ghrelin and des-ghrelin were measured at 0, 30 and 60 min of a 75g OGTT before and after the intervention. Visual analog scales were also administered at 0 and 120 min of the OGTT to assess appetite perception. Food logs were recorded prior to and during the intervention to ensure caloric intake compliance. Compared with pre-intervention conditions, both interventions decreased food intake (P = 0.001) and body fat (P < 0.01). There was no effect on fasting PYY, but both LCD and LCD+INT increased post-prandial PYY iAUC (P < 0.001) relative to pre-intervention. LCD+INT maintained fasting acylated ghrelin (P = 0.06) and suppressed post-prandial acylated ghrelin iAUC (P = 0.04) compared to LCD. Neither intervention impacted circulating des- ghrelin before or following the OGTT. Interestingly, LCD+INT attenuated fasting hunger and maintained fullness compared with LCD (P = 0.05 and P = 0.06, respectively). Taken together, interval exercise favors acylated ghrelin suppression and perception of hunger during a LCD in women with obesity.",2020,"Compared with pre-intervention conditions, both interventions decreased food intake (P=0.001) and body fat (P<0.01).","['women with obesity', 'Twenty-six women with obesity (47.3±2.4 yrs; 37.3±1.2 kg/m 2 ']","['interval exercise (INT', 'LCD+INT', 'Short-term interval exercise', 'LCD', 'supervised interval exercise at 90% HRpeak for 3 min and 50% HRpeak', 'interval exercise favors acylated ghrelin suppression and perception of hunger during a LCD']","['Total PYY, acylated ghrelin and des-ghrelin', 'appetite perception', 'food intake', 'Visual analog scales', 'fasting hunger and maintained fullness']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0450349', 'cui_str': '26'}]","[{'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C2930544', 'cui_str': 'Calorie restricted diet'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0911014', 'cui_str': 'Ghrelin'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0020175', 'cui_str': 'Hungry'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0070358', 'cui_str': 'Peptide YY'}, {'cui': 'C0911014', 'cui_str': 'Ghrelin'}, {'cui': 'C0011702', 'cui_str': '4-(4-Amino-4-Carboxybutyl)-1-(5-Amino-5-Carboxypentyl)-3,5-bis(3-Amino-3-Carboxypropyl)pyridinium'}, {'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0013470', 'cui_str': 'Eating'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0020175', 'cui_str': 'Hungry'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0439650', 'cui_str': 'Fullness'}]",26.0,0.0280904,"Compared with pre-intervention conditions, both interventions decreased food intake (P=0.001) and body fat (P<0.01).","[{'ForeName': 'Steven K', 'Initials': 'SK', 'LastName': 'Malin', 'Affiliation': 'Department of Kinesiology, University of Virginia, Charlottesville, VA, United States; Division of Endocrinology & Metabolism, University of Virginia, Charlottesville, VA, United States; Robert M. Berne Cardiovascular Research Center, University of Virginia, Charlottesville, VA, United States. Electronic address: skm6n@virginia.edu.'}, {'ForeName': 'Emily M', 'Initials': 'EM', 'LastName': 'Heiston', 'Affiliation': 'Department of Kinesiology, University of Virginia, Charlottesville, VA, United States.'}, {'ForeName': 'Nicole M', 'Initials': 'NM', 'LastName': 'Gilbertson', 'Affiliation': 'Department of Kinesiology, University of Virginia, Charlottesville, VA, United States.'}, {'ForeName': 'Natalie Z M', 'Initials': 'NZM', 'LastName': 'Eichner', 'Affiliation': 'Department of Kinesiology, University of Virginia, Charlottesville, VA, United States.'}]",Physiology & behavior,['10.1016/j.physbeh.2020.112978'] 2036,32473959,A randomised controlled trial of the effect of providing online risk information and lifestyle advice for the most common preventable cancers.,"Few trial data are available concerning the impact of personalised cancer risk information on behaviour. This study assessed the short-term effects of providing personalised cancer risk information on cancer risk beliefs and self-reported behaviour. We randomised 1018 participants, recruited through the online platform Prolific, to either a control group receiving cancer-specific lifestyle advice or one of three intervention groups receiving their computed 10-year risk of developing one of the five most common preventable cancers either as a bar chart, a pictograph or a qualitative scale alongside the same lifestyle advice. The primary outcome was change from baseline in computed risk relative to an individual with a recommended lifestyle (RRI) 1 at three months. Secondary outcomes included: health-related behaviours, risk perception, anxiety, worry, intention to change behaviour, and a newly defined concept, risk conviction. After three months there were no between-group differences in change in RRI (p = 0.71). At immediate follow-up, accuracy of absolute risk perception (p < 0.001), absolute and comparative risk conviction (p < 0.001) and intention to increase fruit and vegetables (p = 0.026) and decrease processed meat (p = 0.033) were higher in all intervention groups relative to the control group. The increases in accuracy and conviction were only seen in individuals with high numeracy and low baseline conviction, respectively. These findings suggest that personalised cancer risk information alongside lifestyle advice can increase short-term risk accuracy and conviction without increasing worry or anxiety but has little impact on health-related behaviour. Trial registration: ISRCTN17450583. Registered 30 January 2018.",2020,"At immediate follow-up, accuracy of absolute risk perception (p < 0.001), absolute and comparative risk conviction (p < 0.001) and intention to increase fruit and vegetables (p = 0.026) and decrease processed meat (p = 0.033) were higher in all intervention groups relative to the control group.","['1018 participants, recruited through the online platform Prolific, to either a']","['control group receiving cancer-specific lifestyle advice or one of three intervention groups receiving their computed 10-year risk of developing one of the five most common preventable cancers either as a bar chart, a pictograph or a qualitative scale alongside the same lifestyle advice', 'personalised cancer risk information', 'online risk information and lifestyle advice']","['computed risk relative to an individual with a recommended lifestyle (RRI', 'accuracy and conviction', 'health-related behaviours, risk perception, anxiety, worry, intention to change behaviour, and a newly defined concept, risk conviction', 'accuracy of absolute risk perception', 'absolute and comparative risk conviction', 'change in RRI', 'intention to increase fruit and vegetables', 'cancer risk beliefs and self-reported behaviour']",[],"[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205447', 'cui_str': '1'}, {'cui': 'C1547273', 'cui_str': 'Preventable'}, {'cui': 'C0684240', 'cui_str': 'Chart'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C3875154', 'cui_str': 'Relative to'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0237121', 'cui_str': 'Health-related behavior'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0233481', 'cui_str': 'Worried'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}]",1018.0,0.105156,"At immediate follow-up, accuracy of absolute risk perception (p < 0.001), absolute and comparative risk conviction (p < 0.001) and intention to increase fruit and vegetables (p = 0.026) and decrease processed meat (p = 0.033) were higher in all intervention groups relative to the control group.","[{'ForeName': 'Golnessa', 'Initials': 'G', 'LastName': 'Masson', 'Affiliation': 'The Primary Care Unit, Department of Public Health and Primary Care, University of Cambridge School of Clinical Medicine, Box 113, Cambridge Biomedical Campus, Cambridge CB2 0SR, UK. Electronic address: gh453@medschl.cam.ac.uk.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Mills', 'Affiliation': 'The Primary Care Unit, Department of Public Health and Primary Care, University of Cambridge School of Clinical Medicine, Box 113, Cambridge Biomedical Campus, Cambridge CB2 0SR, UK. Electronic address: kmills@medschl.cam.ac.uk.'}, {'ForeName': 'Simon J', 'Initials': 'SJ', 'LastName': 'Griffin', 'Affiliation': 'The Primary Care Unit, Department of Public Health and Primary Care, University of Cambridge School of Clinical Medicine, Box 113, Cambridge Biomedical Campus, Cambridge CB2 0SR, UK. Electronic address: profgp@medschl.cam.ac.uk.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Sharp', 'Affiliation': 'MRC Epidemiology Unit, University of Cambridge, Institute of Metabolic Science, Cambridge CB2 0QQ, UK. Electronic address: stephen.sharp@mrc-epid.cam.ac.uk.'}, {'ForeName': 'William M P', 'Initials': 'WMP', 'LastName': 'Klein', 'Affiliation': 'National Cancer Institute, Rockville, MD, USA. Electronic address: kleinwm@mail.nih.gov.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Sutton', 'Affiliation': 'The Primary Care Unit, Department of Public Health and Primary Care, University of Cambridge School of Clinical Medicine, Box 113, Cambridge Biomedical Campus, Cambridge CB2 0SR, UK. Electronic address: srs34@medschl.cam.ac.uk.'}, {'ForeName': 'Juliet A', 'Initials': 'JA', 'LastName': 'Usher-Smith', 'Affiliation': 'The Primary Care Unit, Department of Public Health and Primary Care, University of Cambridge School of Clinical Medicine, Box 113, Cambridge Biomedical Campus, Cambridge CB2 0SR, UK. Electronic address: jau20@medschl.cam.ac.uk.'}]",Preventive medicine,['10.1016/j.ypmed.2020.106154'] 2037,32474584,Potentially inappropriate medication use in older adults with mild-moderate Alzheimer's disease: prevalence and associations with adverse events.,"AIM Potentially inappropriate medication (PIM) use is prevalent in older adults and is associated with adverse events, hospitalisation and mortality. We assessed the patterns and associations of PIM use in older adults with mild-to-moderate Alzheimer's Disease (AD), who may represent a particularly vulnerable group. DESIGN Analysis of data from NILVad, an 18-month Randomised Control Trial of Nilvadapine in mild-to-moderate AD. The v2 STOPP criteria were applied in duplicate to identify PIM use. Associations between PIM use and adverse events/unscheduled healthcare visits in addition to the associations between PIM use and AD progression were evaluated. SETTING AND PARTICIPANTS 448 older adults with mild-to-moderate AD from 23 centres in nine European countries. RESULTS Of 448 participants (mean age: 72.56 ± 8.19 years), over half (55.8%) were prescribed a PIM with 30.1% being prescribed 2+ PIMs. The most frequent PIMs were (i) long-term benzodiazepines (11.6% N = 52/448), (ii) selective serotonin reuptake inhibitors without appropriate indication (11.1% N = 50/448), and (iii) Proton-Pump Inhibitors (PPIs) without appropriate indication (10.7% N = 48/448). Increasing number of PIMs was associated with a greater risk of adverse events (IRR 1.17, 1.13-1.19, P < 0.001), serious adverse events (IRR 1.27; 1.17-1.37, P < 0.001), unscheduled hospitalisations (IRR 1.16, 1.03-1.30, P = 0.016) and GP visits (IRR 1.22, 1.15-1.28, P < 0.001). PIM use was not associated with dementia progression. CONCLUSIONS AND IMPLICATIONS PIM use is highly prevalent in mild-to-moderate AD and is associated with adverse events and unscheduled healthcare utilisation. Further attention to de-prescribing in this vulnerable group is warranted.",2020,"Increasing number of PIMs was associated with a greater risk of adverse events (IRR 1.17, 1.13-1.19, P < 0.001), serious adverse events (IRR 1.27; 1.17-1.37, P < 0.001), unscheduled hospitalisations (IRR 1.16, 1.03-1.30, P = 0.016) and GP visits (IRR 1.22, 1.15-1.28, P < 0.001).","['448 older adults with mild-to-moderate AD from 23 centres in nine European countries', 'Of 448 participants (mean age: 72.56\u2009±\u20098.19\xa0years), over half (55.8%) were prescribed a PIM with 30.1% being prescribed 2+ PIMs', 'older adults', ""older adults with mild-moderate Alzheimer's disease"", 'mild-to-moderate AD', ""older adults with mild-to-moderate Alzheimer's Disease (AD""]","['benzodiazepines', 'Nilvadapine', 'inappropriate medication (PIM']","['unscheduled hospitalisations', 'GP visits', 'serious adverse events', 'risk of adverse events']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0002395', 'cui_str': ""Alzheimer's disease""}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0454713', 'cui_str': 'European country'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C2239117', 'cui_str': 'Prescription of drug'}, {'cui': 'C4042848', 'cui_str': 'PIM List'}]","[{'cui': 'C0005064', 'cui_str': 'Benzodiazepine Compounds'}, {'cui': 'C3542467', 'cui_str': 'Inappropriate'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C4042848', 'cui_str': 'PIM List'}]","[{'cui': 'C3854240', 'cui_str': 'Unscheduled'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",448.0,0.0647382,"Increasing number of PIMs was associated with a greater risk of adverse events (IRR 1.17, 1.13-1.19, P < 0.001), serious adverse events (IRR 1.27; 1.17-1.37, P < 0.001), unscheduled hospitalisations (IRR 1.16, 1.03-1.30, P = 0.016) and GP visits (IRR 1.22, 1.15-1.28, P < 0.001).","[{'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Murphy', 'Affiliation': 'Department of Age-Related Healthcare, Tallaght University Hospital, Dublin, Ireland.'}, {'ForeName': 'Adam H', 'Initials': 'AH', 'LastName': 'Dyer', 'Affiliation': 'Department of Age-Related Healthcare, Tallaght University Hospital, Dublin, Ireland.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Lawlor', 'Affiliation': 'Department of Medical Gerontology, School of Medicine, Trinity College Dublin, Dublin, Ireland.'}, {'ForeName': 'Sean P', 'Initials': 'SP', 'LastName': 'Kennelly', 'Affiliation': 'Department of Age-Related Healthcare, Tallaght University Hospital, Dublin, Ireland.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Age and ageing,['10.1093/ageing/afaa067'] 2038,32474993,Melatonin In Acute Mania Investigation (MIAMI-UK). A randomized controlled trial of add-on melatonin in bipolar disorder.,"OBJECTIVES Current options for treating emergent episodes of hypomania and mania in bipolar disorder are limited. Our objective was to compare the effectiveness and safety of add-on melatonin in hypomania or mania over 3 weeks as a well-tolerated therapy. METHODS A randomized, double-blind, parallel-group, 3-week comparison of modified release melatonin (n = 21) vs placebo (n = 20) in adult bipolar patients aged 18-65 years. Permuted block randomization was used with participants and investigators masked to treatment allocation. Trial registration is ISRCTN28988273 and EUdraCT2008-000281-23. Approved by the South Central National Research Ethics Service (Oxford REC A) ref: 09/H0604/63. RESULTS The trial was negative as there was no significant difference between melatonin and placebo on the primary outcome-mean Young Mania Rating Scale (YMRS) score at Day 21: (mean difference [MD] -1.77 ([95% CI: -6.39 to 2.85]; P = .447). Significantly fewer patients on melatonin scored 10 or more on the Altman Self Rating Mania Scale: (odds ratio [OR] 0.164 [95% CI: 0.0260-1.0002]; P = .05). Quick Inventory of Depression Symptomatology Clinician Version-16 (QIDS-C16) scores were not significantly different. (OR 1.77 [95% CI: 0.43-7.29]; P = .430). The proportion of patients scoring less than or equal to 5 on the self-report QIDS-SR16 at end-point was greater for the melatonin group (OR 8.35 [95% CI: 1.04-67.23]; P = .046). CONCLUSIONS In this small trial, melatonin did not effectively treat emerging hypomania or mania as there was no significant difference on the primary outcome. The sample size limitation and secondary outcomes suggest further investigation of melatonin treatment in mood episodes is indicated.",2020,The trial was negative as there was no significant difference between melatonin and placebo on the primary outcome - mean Young Mania Rating Scale (YMRS) score at Day 21: (mean difference (MD) -1.77 ([95%CI:-6.39 to 2.85]; p=0.447).,"['adult bipolar patients aged 18-65 years', 'bipolar disorder']","['modified release melatonin (n=21) vs placebo', 'Melatonin', 'melatonin and placebo', 'melatonin']","['Altman Self Rating Mania Scale (ASRM', 'primary outcome - mean Young Mania Rating Scale (YMRS) score', 'effectiveness and safety', 'Quick Inventory of Depression Symptomatology Clinician Version-16 (QIDS-C16) scores']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0443156', 'cui_str': 'Bipolar'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005586', 'cui_str': 'Bipolar disorder'}]","[{'cui': 'C4544813', 'cui_str': 'Modified-release'}, {'cui': 'C0025219', 'cui_str': 'Melatonin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0338831', 'cui_str': 'Mania'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4087288', 'cui_str': 'Young mania rating scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0585291', 'cui_str': 'Four times daily'}]",,0.550988,The trial was negative as there was no significant difference between melatonin and placebo on the primary outcome - mean Young Mania Rating Scale (YMRS) score at Day 21: (mean difference (MD) -1.77 ([95%CI:-6.39 to 2.85]; p=0.447).,"[{'ForeName': 'Digby J', 'Initials': 'DJ', 'LastName': 'Quested', 'Affiliation': 'Oxford Health NHS Foundation Trust, Warneford Hospital, Oxford, UK.'}, {'ForeName': 'Jessica C', 'Initials': 'JC', 'LastName': 'Gibson', 'Affiliation': 'Oxford Health NHS Foundation Trust, Warneford Hospital, Oxford, UK.'}, {'ForeName': 'Ann L', 'Initials': 'AL', 'LastName': 'Sharpley', 'Affiliation': 'Department of Psychiatry, University of Oxford, Warneford Hospital, Oxford, UK.'}, {'ForeName': 'Julia H', 'Initials': 'JH', 'LastName': 'Cordey', 'Affiliation': 'Oxford Health NHS Foundation Trust, Warneford Hospital, Oxford, UK.'}, {'ForeName': 'Alexis', 'Initials': 'A', 'LastName': 'Economou', 'Affiliation': 'Oxford Health NHS Foundation Trust, Warneford Hospital, Oxford, UK.'}, {'ForeName': 'Franco', 'Initials': 'F', 'LastName': 'De Crescenzo', 'Affiliation': 'Oxford Health NHS Foundation Trust, Warneford Hospital, Oxford, UK.'}, {'ForeName': 'Merryn', 'Initials': 'M', 'LastName': 'Voysey', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Lawson', 'Affiliation': 'Oxford Health NHS Foundation Trust, Warneford Hospital, Oxford, UK.'}, {'ForeName': 'Jennifer M', 'Initials': 'JM', 'LastName': 'Rendell', 'Affiliation': 'Department of Psychiatry, University of Oxford, Warneford Hospital, Oxford, UK.'}, {'ForeName': 'Hasanen', 'Initials': 'H', 'LastName': 'Al-Taiar', 'Affiliation': 'Oxford Health NHS Foundation Trust, Warneford Hospital, Oxford, UK.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Lennox', 'Affiliation': 'Oxford Health NHS Foundation Trust, Warneford Hospital, Oxford, UK.'}, {'ForeName': 'Farooq', 'Initials': 'F', 'LastName': 'Ahmad', 'Affiliation': 'Berkshire NHS Foundation Trust, Prospect Park Hospital, Reading, Berkshire, UK.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Geddes', 'Affiliation': 'Oxford Health NHS Foundation Trust, Warneford Hospital, Oxford, UK.'}]",Bipolar disorders,['10.1111/bdi.12944'] 2039,32476617,Vagus Nerve Stimulation Paired With Upper-Limb Rehabilitation After Stroke: One-Year Follow-up.,"Background . Vagus nerve stimulation (VNS) paired with rehabilitation may improve upper-limb impairment and function after ischemic stroke. Objective . To report 1-year safety, feasibility, adherence, and outcome data from a home exercise program paired with VNS using long-term follow-up data from a randomized double-blind study of rehabilitation therapy paired with Active VNS (n = 8) or Control VNS (n = 9). Methods . All people were implanted with a VNS device and underwent 6 weeks in clinic therapy with Control or Active VNS followed by home exercises through day 90. Thereafter, participants and investigators were unblinded. The Control VNS group then received 6 weeks in-clinic Active VNS (Cross-VNS group). All participants then performed an individualized home exercise program with self-administered Active VNS. Data from this phase are reported here. Outcome measures were Fugl-Meyer Assessment-Upper Extremity (FMA-UE), Wolf Motor Function Test (Functional and Time), Box and Block Test, Nine-Hole Peg Test, Stroke Impact Scale, and Motor Activity Log. Results . There were no VNS treatment-related serious adverse events during the long-term therapy. Two participants discontinued prior to receiving the full crossover VNS. On average, participants performed 200 ± 63 home therapy sessions, representing device use on 57.4% of home exercise days available for each participant. Pooled analysis revealed that 1 year after randomization, the FMA-UE score increased by 9.2 points (95% CI = 4.7 to 13.7; P = .001; n = 15). Other functional measures were also improved at 1 year. Conclusions . VNS combined with rehabilitation is feasible, with good long-term adherence, and may improve arm function after ischemic stroke.",2020,"VNS combined with rehabilitation is feasible, with good long-term adherence, and may improve arm function after ischemic stroke.",['After Stroke'],"['clinic therapy with Control or Active VNS followed by home exercises through day 90', 'rehabilitation therapy paired with Active VNS (n = 8) or Control VNS', 'Vagus Nerve Stimulation Paired With Upper-Limb Rehabilitation', 'home exercise program paired with VNS', 'individualized home exercise program with self-administered Active VNS', 'VNS combined with rehabilitation', 'Vagus nerve stimulation (VNS) paired with rehabilitation']","['Fugl-Meyer Assessment-Upper Extremity (FMA-UE), Wolf Motor Function Test (Functional and Time), Box and Block Test, Nine-Hole Peg Test, Stroke Impact Scale, and Motor Activity Log', 'FMA-UE score', 'VNS treatment-related serious adverse events']","[{'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}]","[{'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C2350432', 'cui_str': 'Vagal Nerve Stimulation'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0475647', 'cui_str': 'Home exercise program'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0325001', 'cui_str': 'Wolf'}, {'cui': 'C0234130', 'cui_str': 'Motor function'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0006080', 'cui_str': 'Boxing'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0451335', 'cui_str': 'Nine hole peg test'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C2350432', 'cui_str': 'Vagal Nerve Stimulation'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.123532,"VNS combined with rehabilitation is feasible, with good long-term adherence, and may improve arm function after ischemic stroke.","[{'ForeName': 'Jesse', 'Initials': 'J', 'LastName': 'Dawson', 'Affiliation': 'University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Navzer D', 'Initials': 'ND', 'LastName': 'Engineer', 'Affiliation': 'MicroTransponder, Inc, Austin, TX, USA.'}, {'ForeName': 'Cecília N', 'Initials': 'CN', 'LastName': 'Prudente', 'Affiliation': 'MicroTransponder, Inc, Austin, TX, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Pierce', 'Affiliation': 'MicroTransponder, Inc, Austin, TX, USA.'}, {'ForeName': 'Gerard', 'Initials': 'G', 'LastName': 'Francisco', 'Affiliation': 'The University of Texas Health Science Center at Houston (UTHealth), TX, USA.'}, {'ForeName': 'Nuray', 'Initials': 'N', 'LastName': 'Yozbatiran', 'Affiliation': 'The University of Texas Health Science Center at Houston (UTHealth), TX, USA.'}, {'ForeName': 'W Brent', 'Initials': 'WB', 'LastName': 'Tarver', 'Affiliation': 'MicroTransponder, Inc, Austin, TX, USA.'}, {'ForeName': 'Reema', 'Initials': 'R', 'LastName': 'Casavant', 'Affiliation': 'MicroTransponder, Inc, Austin, TX, USA.'}, {'ForeName': 'Danielle K', 'Initials': 'DK', 'LastName': 'Kline', 'Affiliation': 'University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Steven C', 'Initials': 'SC', 'LastName': 'Cramer', 'Affiliation': 'University of California, Los Angeles, CA, USA.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Van de Winckel', 'Affiliation': 'University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Teresa J', 'Initials': 'TJ', 'LastName': 'Kimberley', 'Affiliation': 'University of Minnesota, Minneapolis, MN, USA.'}]",Neurorehabilitation and neural repair,['10.1177/1545968320924361'] 2040,32476619,Task-Specific Versus Impairment-Based Training on Locomotor Performance in Individuals With Chronic Spinal Cord Injury: A Randomized Crossover Study.,"Background . Many research studies attempting to improve locomotor function following motor incomplete spinal cord injury (iSCI) focus on providing stepping practice. However, observational studies of physical therapy strategies suggest the amount of stepping practice during clinical rehabilitation is limited; rather, many interventions focus on mitigating impairments underlying walking dysfunction. Objective . The purpose of this blinded-assessor randomized trial was to evaluate the effects of task-specific versus impairment-based interventions on walking outcomes in individuals with iSCI. Methods . Using a crossover design, ambulatory participants with iSCI >1-year duration performed either task-specific (upright stepping) or impairment-based training for up to 20 sessions over ≤6 weeks, with interventions alternated after >4 weeks delay. Both strategies focused on achieving higher cardiovascular intensities, with training specificity manipulated by practicing only stepping practice in variable contexts or practicing tasks targeting impairments underlying locomotor dysfunction (strengthening, balance tasks, and recumbent stepping). Results . Significantly greater increases in fastest overground and treadmill walking speeds were observed following task-specific versus impairment-based training, with moderate associations between differences in amount of practice and outcomes. Gains in balance confidence were also observed following task-specific vs impairment-based training, although incidence of falls was also increased with the former protocol. Limited gains were observed with impairment-based training except for peak power during recumbent stepping tests. Conclusion . The present study reinforces work from other patient populations that the specificity of task practice is a critical determinant of locomotor outcomes and suggest impairment-based exercises may not translate to improvements in functional tasks. Clinical Trial Registration URL . https://clinicaltrials.gov/ ; Unique Identifier: NCT02115685.",2020,"Significantly greater increases in fastest overground and treadmill walking speeds were observed following task-specific versus impairment-based training, with moderate associations between differences in amount of practice and outcomes.","['Individuals With Chronic Spinal Cord Injury', 'individuals with iSCI', 'ambulatory participants with iSCI >1-year duration performed either']","['Task-Specific Versus Impairment-Based Training', 'task-specific versus impairment-based interventions', 'task-specific (upright stepping) or impairment-based training']","['Gains in balance confidence', 'incidence of falls', 'Locomotor Performance', 'walking outcomes', 'fastest overground and treadmill walking speeds']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0037929', 'cui_str': 'Spinal cord injury'}, {'cui': 'C4545488', 'cui_str': 'Incomplete spinal cord injury'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C4280965', 'cui_str': 'Greater than one'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}]",,0.0682405,"Significantly greater increases in fastest overground and treadmill walking speeds were observed following task-specific versus impairment-based training, with moderate associations between differences in amount of practice and outcomes.","[{'ForeName': 'Jennifer K', 'Initials': 'JK', 'LastName': 'Lotter', 'Affiliation': 'Rehabilitation Hospital of Indiana, Indianapolis, IN, USA.'}, {'ForeName': 'Christopher E', 'Initials': 'CE', 'LastName': 'Henderson', 'Affiliation': 'Rehabilitation Hospital of Indiana, Indianapolis, IN, USA.'}, {'ForeName': 'Abbey', 'Initials': 'A', 'LastName': 'Plawecki', 'Affiliation': 'Rehabilitation Hospital of Indiana, Indianapolis, IN, USA.'}, {'ForeName': 'Molly E', 'Initials': 'ME', 'LastName': 'Holthus', 'Affiliation': 'Rehabilitation Hospital of Indiana, Indianapolis, IN, USA.'}, {'ForeName': 'Emily H', 'Initials': 'EH', 'LastName': 'Lucas', 'Affiliation': 'Rehabilitation Hospital of Indiana, Indianapolis, IN, USA.'}, {'ForeName': 'Marzieh M', 'Initials': 'MM', 'LastName': 'Ardestani', 'Affiliation': 'Rehabilitation Hospital of Indiana, Indianapolis, IN, USA.'}, {'ForeName': 'Brian D', 'Initials': 'BD', 'LastName': 'Schmit', 'Affiliation': 'Marquette University, Milwaukee, WI, USA.'}, {'ForeName': 'T George', 'Initials': 'TG', 'LastName': 'Hornby', 'Affiliation': 'Rehabilitation Hospital of Indiana, Indianapolis, IN, USA.'}]",Neurorehabilitation and neural repair,['10.1177/1545968320927384'] 2041,32482626,Prioritisation of treatment goals among older patients with non-curable cancer: the OPTion randomised controlled trial in Dutch primary care.,"BACKGROUND Older patients with cancer often find it difficult to take part in shared decision making. AIM To assess the utility of the Outcome Prioritisation Tool (OPT), designed to aid discussion with a patient in regards to their treatment goals, to empower patients with cancer through structured conversations about generic treatment goals with GPs. DESIGN AND SETTING A randomised controlled trial of 114 Dutch participants recruited between November 2015 and January 2019, aged ≥60 years with non-curable cancer who had to make a treatment decision with an oncologist. The intervention group used the OPT while the control group received care as usual. METHOD The primary outcome was patient empowerment using the score on the decision self-efficacy (DSE) scale. Secondary outcomes were symptoms measures of fatigue, anxiety, and depression. The experiences of participants were also explored. RESULTS No effect was found on patient empowerment between the OPT group ( n = 48; DSE 86.8; standard deviation [SD] = 18.2) and the control group ( n = 58; DSE 84.2; SD = 17.6; P = 0.47). In the OPT group, although statistically non-significant, fewer patients had low empowerment (18.8%, n = 9 versus 24.1%, n = 14; P = 0.50), but they did have statistically significant lower mean anxiety scores (6.0, SD = 4.6 versus 7.6, SD = 4.4; P<0.05) and less mild fatigue (58.8%, n = 30 versus 77.2%, n = 44; P = 0.05). Overall, 44.8% ( n = 13) of patients indicated that the OPT-facilitated conversation helped them make a treatment decision, and 31.1% ( n = 14) of the GPs reported that they gained new insights from the conversation. CONCLUSION An OPT-facilitated conversation about generic treatment goals between patients and their GPs is associated with less anxiety and fatigue, but did not show statistically significant improvements in patient empowerment. Adding the OPT to routine care might ensure more patient-tailored care.",2020,"In the OPT group, although statistically non-significant, fewer patients had low empowerment (18.8%, n = 9 versus 24.1%, n = 14; P = 0.50), but they did have statistically significant lower mean anxiety scores (6.0, SD = 4.6 versus 7.6, SD = 4.4; P<0.05) and less mild fatigue (58.8%, n = 30 versus 77.2%, n = 44; P = 0.05).","['Older patients with cancer', 'older patients with non-curable cancer', 'patients with cancer through structured conversations about generic treatment goals with GPs', '114 Dutch participants recruited between November 2015 and January 2019, aged ≥60 years with non-curable cancer who had to make a treatment decision with an oncologist']","['OPT while the control group received care as usual', 'Outcome Prioritisation Tool (OPT']","['symptoms measures of fatigue, anxiety, and depression', 'patient empowerment using the score on the decision self-efficacy (DSE) scale', 'mild fatigue', 'anxiety and fatigue', 'patient empowerment', 'mean anxiety scores', 'low empowerment']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0085155', 'cui_str': 'Generic Drugs'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0272302', 'cui_str': 'Gray platelet syndrome'}, {'cui': 'C4708785', 'cui_str': '114'}, {'cui': 'C0013331', 'cui_str': 'Dutch'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0259990', 'cui_str': 'Oncologists'}]","[{'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C3853035', 'cui_str': 'Patient Empowerment'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0679959', 'cui_str': 'Empowerment'}]",114.0,0.0458868,"In the OPT group, although statistically non-significant, fewer patients had low empowerment (18.8%, n = 9 versus 24.1%, n = 14; P = 0.50), but they did have statistically significant lower mean anxiety scores (6.0, SD = 4.6 versus 7.6, SD = 4.4; P<0.05) and less mild fatigue (58.8%, n = 30 versus 77.2%, n = 44; P = 0.05).","[{'ForeName': 'Mariken E', 'Initials': 'ME', 'LastName': 'Stegmann', 'Affiliation': 'Department of General Practice and Elderly Care Medicine, University Medical Centre Groningen, University of Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Daan', 'Initials': 'D', 'LastName': 'Brandenbarg', 'Affiliation': 'Department of General Practice and Elderly Care Medicine, University Medical Centre Groningen, University of Groningen, Groningen, the Netherlands.'}, {'ForeName': 'An Kl', 'Initials': 'AK', 'LastName': 'Reyners', 'Affiliation': 'Department of Medical Oncology, University Medical Centre Groningen, University of Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Wouter H', 'Initials': 'WH', 'LastName': 'van Geffen', 'Affiliation': 'Department of Pulmonary Diseases, Medical Centre Leeuwarden, Leeuwarden, the Netherlands.'}, {'ForeName': 'T Jeroen N', 'Initials': 'TJN', 'LastName': 'Hiltermann', 'Affiliation': 'Department of Pulmonary Diseases and Tuberculosis, University Medical Centre Groningen, University of Groningen, Groningen, the Netherlands.'}, {'ForeName': 'Annette J', 'Initials': 'AJ', 'LastName': 'Berendsen', 'Affiliation': 'Department of General Practice and Elderly Care Medicine, University Medical Centre Groningen, University of Groningen, Groningen, the Netherlands.'}]",The British journal of general practice : the journal of the Royal College of General Practitioners,['10.3399/bjgp20X710405'] 2042,32479750,A Randomized Controlled Trial of the Lowest Effective Dose of Acetazolamide for Acute Mountain Sickness Prevention.,"BACKGROUND Acetazolamide is the most common medication used for acute mountain sickness prevention, with speculation that a reduced dose may be as efficacious as standard dosing with fewer side effects. METHODS This double-blind, randomized, controlled noninferiority trial compared acetazolamide 62.5 mg twice daily to the standard dose acetazolamide 125 mg twice daily starting the evening prior to ascent from 1240 m (4100 ft) to 3810 m (12,570 ft) over 4 hours. The primary outcome was acute mountain sickness incidence (ie, headache, Lake Louise Questionnaire ≥3, and another symptom). RESULTS A total of 106 participants were analyzed, with 51 (48%) randomized to 125 mg and 55 (52%) to 62.5 mg, with a combined acute mountain sickness incidence of 53 (50%) and mean severity of 3 (± 2.1). The 62.5-mg group failed to fall within the prespecified 26% noninferiority margin for acute mountain sickness incidence (62.5 mg = 30 [55%] vs 125 mg = 23 [45%], 95% confidence interval [CI] -11% to 30%). Participants in the 62.5-mg group had a higher risk of acute mountain sickness (odds ratio = 1.5, 95% CI 0.7-3.2) and moderate acute mountain sickness (odds ratio = 1.8, 95% CI 0.6-5.9), with a number needed to harm (NNH) of 9, with a number needed to treat (NNT) in the 125-mg group of 4.8. Increased acute mountain sickness incidence and symptom severity corresponded to lower weight-based and body mass index dosing, with similar side effects between groups. CONCLUSION Acetazolamide 62.5 mg twice daily failed to demonstrate equal effectiveness to 125 mg twice daily for prevention of acute mountain sickness. With increased risk and no demonstrable symptomatic or physiologic benefits, acetazolamide 62.5 mg twice daily should not be recommended for acute mountain sickness prevention.",2020,"Participants in the 62.5 mg group had a higher risk of acute mountain sickness (OR = 1.5, 95% CI 0.7 to 3.2) and moderate acute mountain sickness (OR = 1.8, 95% CI 0.6 to 5.9), with a NNH of 9, with a NNT in the 125 mg group of 4.8.","['106 participants', 'Acute Mountain Sickness Prevention']","['acetazolamide', 'Acetazolamide']","['higher risk of acute mountain sickness', 'acute mountain sickness incidence and symptom severity', 'moderate acute mountain sickness', 'acute mountain sickness incidence', 'acute mountain sickness incidence (headache and Lake Louise Questionnaire ≥ 3 and another symptom']","[{'cui': 'C0238284', 'cui_str': 'Acute mountain sickness'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}]","[{'cui': 'C0000981', 'cui_str': 'Acetazolamide'}]","[{'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0238284', 'cui_str': 'Acute mountain sickness'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0337049', 'cui_str': 'Lake'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",106.0,0.0551059,"Participants in the 62.5 mg group had a higher risk of acute mountain sickness (OR = 1.5, 95% CI 0.7 to 3.2) and moderate acute mountain sickness (OR = 1.8, 95% CI 0.6 to 5.9), with a NNH of 9, with a NNT in the 125 mg group of 4.8.","[{'ForeName': 'Grant S', 'Initials': 'GS', 'LastName': 'Lipman', 'Affiliation': 'Department of Emergency Medicine, Stanford University School of Medicine, Palo Alto, Calif. Electronic address: grantlip@hotmail.com.'}, {'ForeName': 'Carrie', 'Initials': 'C', 'LastName': 'Jurkiewicz', 'Affiliation': 'Department of Emergency Medicine, Stanford University School of Medicine, Palo Alto, Calif.'}, {'ForeName': 'Andre', 'Initials': 'A', 'LastName': 'Burnier', 'Affiliation': 'Stanford Emergency Medicine Residency, Stanford University School of Medicine, Palo Alto, Calif.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Marvel', 'Affiliation': 'Department of Emergency Medicine, Stanford University School of Medicine, Palo Alto, Calif.'}, {'ForeName': 'Caleb', 'Initials': 'C', 'LastName': 'Phillips', 'Affiliation': 'Department of Computational Science, University of Colorado, Golden.'}, {'ForeName': 'Cassie', 'Initials': 'C', 'LastName': 'Lowry', 'Affiliation': 'MountainView Regional Medical Center, Las Cruces, NM.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Hawkins', 'Affiliation': 'Stanford University School of Medicine, Palo Alto, Calif.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Navlyt', 'Affiliation': 'Stanford Emergency Medicine Residency, Stanford University School of Medicine, Palo Alto, Calif.'}, {'ForeName': 'Erik R', 'Initials': 'ER', 'LastName': 'Swenson', 'Affiliation': 'Medical Service, VA Puget Sound Health Care System, and Division of Pulmonary, Critical Care, and Sleep Medicine, University of Washington, Seattle.'}]",The American journal of medicine,['10.1016/j.amjmed.2020.05.003'] 2043,32479786,"Neuroleptic strategies for terminal agitation in patients with cancer and delirium at an acute palliative care unit: a single-centre, double-blind, parallel-group, randomised trial.","BACKGROUND The role of neuroleptics for terminal agitated delirium is controversial. We assessed the effect of three neuroleptic strategies on refractory agitation in patients with cancer with terminal delirium. METHODS In this single-centre, double-blind, parallel-group, randomised trial, patients with advanced cancer, aged at least 18 years, admitted to the palliative and supportive care unit at the University of Texas MD Anderson Cancer Center (Houston, TX, USA), with refractory agitation, despite low-dose haloperidol, were randomly assigned to receive intravenous haloperidol dose escalation at 2 mg every 4 h, neuroleptic rotation with chlorpromazine at 25 mg every 4 h, or combined haloperidol at 1 mg and chlorpromazine at 12·5 mg every 4 h, until death or discharge. Rescue doses identical to the scheduled doses were administered at inception, and then hourly as needed. Permuted block randomisation (block size six; 1:1:1) was done, stratified by baseline Richmond Agitation Sedation Scale (RASS) scores. Research staff, clinicians, patients, and caregivers were masked to group assignment. The primary outcome was change in RASS score from time 0 to 24 h. Comparisons among group were done by modified intention-to-treat analysis. This completed study is registered with ClinicalTrials.gov, NCT03021486. FINDINGS Between July 5, 2017, and July 1, 2019, 998 patients were screened for eligibility, with 68 being enrolled and randomly assigned to treatment; 45 received the masked study interventions (escalation n=15, rotation n=16, combination n=14). RASS score decreased significantly within 30 min and remained low at 24 h in the escalation group (n=10, mean RASS score change between 0 h and 24 h -3·6 [95% CI -5·0 to -2·2]), rotation group (n=11, -3·3 [-4·4 to -2·2]), and combination group (n=10, -3·0 [-4·6 to -1·4]), with no difference among groups (p=0·71). The most common serious toxicity was hypotension (escalation n=6 [40%], rotation n=5 [31%], combination n=3 [21%]); there were no treatment-related deaths. INTERPRETATION Our data provide preliminary evidence that the three strategies of neuroleptics might reduce agitation in patients with terminal agitation. These findings are in the context of the single-centre design, small sample size, and lack of a placebo-only group. FUNDING National Institute of Nursing Research.",2020,"RASS score decreased significantly within 30 min and remained low at 24 h in the escalation group (n=10, mean RASS score change between 0 h and 24 h -3·6 [95% CI -5·0 to -2·2]), rotation group (n=11, -3·3","['patients with terminal agitation', 'patients with cancer and delirium at an acute palliative care unit', 'Between July 5, 2017, and July 1, 2019, 998 patients were screened for eligibility, with 68 being enrolled and randomly assigned to treatment; 45 received the masked study interventions (escalation n=15, rotation n=16, combination n=14', 'patients with cancer with terminal delirium', 'patients with advanced cancer, aged at least 18 years, admitted to the palliative and supportive care unit at the University of Texas MD Anderson Cancer Center (Houston, TX, USA), with refractory agitation, despite low-dose']","['neuroleptic strategies', 'Neuroleptic strategies', 'haloperidol', 'intravenous haloperidol dose escalation at 2 mg every 4 h, neuroleptic rotation with chlorpromazine at 25 mg every 4 h, or combined haloperidol at 1\u2008mg and chlorpromazine']","['mean RASS score change', 'RASS score', 'Agitation Sedation Scale (RASS) scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4087165', 'cui_str': 'Terminal agitation'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0030231', 'cui_str': 'Palliative care'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0587605', 'cui_str': 'Palliative care service'}, {'cui': 'C0344211', 'cui_str': 'Support'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0039711', 'cui_str': 'Texas'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0085631', 'cui_str': 'Feeling agitated'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}]","[{'cui': 'C0040615', 'cui_str': 'Antipsychotic agent'}, {'cui': 'C0018546', 'cui_str': 'Haloperidol'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0008286', 'cui_str': 'Chlorpromazine'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4720839', 'cui_str': 'Richmond agitation-sedation scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0085631', 'cui_str': 'Feeling agitated'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",998.0,0.653147,"RASS score decreased significantly within 30 min and remained low at 24 h in the escalation group (n=10, mean RASS score change between 0 h and 24 h -3·6 [95% CI -5·0 to -2·2]), rotation group (n=11, -3·3","[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Hui', 'Affiliation': 'Department of Palliative Care, Rehabilitation and Integrative Medicine, University of Texas MD Anderson Cancer Center, Houston, TX, USA. Electronic address: dhui@mdanderson.org.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'De La Rosa', 'Affiliation': 'Department of Palliative Care, Rehabilitation and Integrative Medicine, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Annie', 'Initials': 'A', 'LastName': 'Wilson', 'Affiliation': 'Department of Palliative Care, Rehabilitation and Integrative Medicine, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Thuc', 'Initials': 'T', 'LastName': 'Nguyen', 'Affiliation': 'Department of Palliative Care, Rehabilitation and Integrative Medicine, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Jimin', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'Department of Biostatistics, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Marvin', 'Initials': 'M', 'LastName': 'Delgado-Guay', 'Affiliation': 'Department of Palliative Care, Rehabilitation and Integrative Medicine, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Ahsan', 'Initials': 'A', 'LastName': 'Azhar', 'Affiliation': 'Department of Palliative Care, Rehabilitation and Integrative Medicine, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Arthur', 'Affiliation': 'Department of Palliative Care, Rehabilitation and Integrative Medicine, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Epner', 'Affiliation': 'Department of Palliative Care, Rehabilitation and Integrative Medicine, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Haider', 'Affiliation': 'Department of Palliative Care, Rehabilitation and Integrative Medicine, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Maxine', 'Initials': 'M', 'LastName': 'De La Cruz', 'Affiliation': 'Department of Palliative Care, Rehabilitation and Integrative Medicine, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'Heung', 'Affiliation': 'Department of Palliative Care, Rehabilitation and Integrative Medicine, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Kimberson', 'Initials': 'K', 'LastName': 'Tanco', 'Affiliation': 'Department of Palliative Care, Rehabilitation and Integrative Medicine, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Shalini', 'Initials': 'S', 'LastName': 'Dalal', 'Affiliation': 'Department of Palliative Care, Rehabilitation and Integrative Medicine, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Akhila', 'Initials': 'A', 'LastName': 'Reddy', 'Affiliation': 'Department of Palliative Care, Rehabilitation and Integrative Medicine, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Williams', 'Affiliation': 'Department of Palliative Care, Rehabilitation and Integrative Medicine, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Sapna', 'Initials': 'S', 'LastName': 'Amin', 'Affiliation': 'Department of Investigational Pharmacy, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Terri S', 'Initials': 'TS', 'LastName': 'Armstrong', 'Affiliation': 'Neuro-Oncology Branch, Centre for Cancer Research, National Cancer Institute, National Institutes of Health, Bethesda, MD, USA.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Breitbart', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Memorial Sloan Kettering Cancer Center, New York, NY, USA.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Bruera', 'Affiliation': 'Department of Palliative Care, Rehabilitation and Integrative Medicine, University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}]",The Lancet. Oncology,['10.1016/S1470-2045(20)30307-7'] 2044,32481404,Exploratory study of clinical effectiveness and safety of TJ-116 bukuryoingohangekobokuto for anxiety and postoperative water brash in esophageal cancer patients (TJ116E).,"BACKGROUND Patients with esophageal cancer suffer from anxiety in the perioperative period surrounding esophagectomy; this may increase the risk of postoperative complications. In particular, postoperative aspiration pneumonia carries a high risk of hospital mortality. Bukuryoingohangekobokuto (BRIHK) is a traditional Japanese medicine formula used to treat anxiety, the feeling of a foreign body in the esophagus, and water brash. We hypothesize that BRIHK might be effective for both anxiety and water brash in perioperative patients with esophageal cancer. The aim of this study is to evaluate the efficacy and safety of BRIHK compared to a placebo for anxiety and water brash in perioperative esophageal cancer patients. METHOD/DESIGN This will be a single-center, single blind, placebo-controlled randomized clinical trial. Twenty-four patients with esophageal cancer undergoing radical resection surgery will be registered to participate, then randomly and blindly assigned to the BRIHK treatment group or control group. Patients will be administered BRIHK or the placebo from 2 weeks before to 6 weeks after surgery. Primary outcome measures will be anxiety and depression (assessed using the Hospital Anxiety and Depression Scale), and water brash (assessed using the 10-item Eating Assessment Tool, Esophagus and Stomach Surgery Symptom Scale, and videofluoroscopy swallowing measurement). Incidences of aspiration pneumonia will be noted and abdominal gas volume, inflammatory markers, and nutrition status will be evaluated. DISCUSSION This investigative study will provide clinical evidence of BRIHK administration for anxiety and water brash, which might improve mental distress and reduce postoperative mortality. TRIAL REGISTRATION The protocol and progress are registered on the Japan Registry of Clinical Trials (jRCT s021190001) and University Hospital Medical Information Network (UMIN000031330). The protocol was approved by the Japanese Ministry of Health, Labour and Welfare certified clinical research review board, Tohoku University (CRB2180001).",2020,"Primary outcome measures will be anxiety and depression (assessed using the Hospital Anxiety and Depression Scale), and water brash (assessed using the 10-item Eating Assessment Tool, Esophagus and Stomach Surgery Symptom Scale, and videofluoroscopy swallowing measurement).","['Twenty-four patients with esophageal cancer undergoing', 'Patients with esophageal cancer suffer from anxiety in the perioperative period surrounding esophagectomy', 'perioperative esophageal cancer patients', 'perioperative patients with esophageal cancer', 'esophageal cancer patients (TJ116E']","['TJ-116 bukuryoingohangekobokuto', 'BRIHK treatment group or control group', 'Bukuryoingohangekobokuto (BRIHK', 'radical resection surgery', 'BRIHK', 'placebo']","['anxiety and depression (assessed using the Hospital Anxiety and Depression Scale), and water brash (assessed using the 10-item Eating Assessment Tool, Esophagus and Stomach Surgery Symptom Scale, and videofluoroscopy swallowing measurement', 'efficacy and safety']","[{'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0014859', 'cui_str': 'Neoplasm of esophagus'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C2712230', 'cui_str': 'Perioperative Period'}, {'cui': 'C1282914', 'cui_str': 'Circumscribed'}, {'cui': 'C0085198', 'cui_str': 'Esophagectomy'}]","[{'cui': 'C4517541', 'cui_str': '116'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0302912', 'cui_str': 'Radical'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C3539657', 'cui_str': 'Hospital anxiety and depression scale'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0018834', 'cui_str': 'Heartburn'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0336791', 'cui_str': 'Tool'}, {'cui': 'C0014876', 'cui_str': 'Esophageal structure'}, {'cui': 'C0192398', 'cui_str': 'Operation on stomach'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0412099', 'cui_str': 'Videofluoroscopy swallow'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",24.0,0.102714,"Primary outcome measures will be anxiety and depression (assessed using the Hospital Anxiety and Depression Scale), and water brash (assessed using the 10-item Eating Assessment Tool, Esophagus and Stomach Surgery Symptom Scale, and videofluoroscopy swallowing measurement).","[{'ForeName': 'Ryutaro', 'Initials': 'R', 'LastName': 'Arita', 'Affiliation': 'Department of Kampo Medicine.'}, {'ForeName': 'Shin', 'Initials': 'S', 'LastName': 'Takayama', 'Affiliation': 'Department of Kampo Medicine.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Okamoto', 'Affiliation': 'Department of Surgery, Tohoku University Hospital.'}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Koseki', 'Affiliation': 'Department of Surgery, Tohoku University Hospital.'}, {'ForeName': 'Yusuke', 'Initials': 'Y', 'LastName': 'Taniyama', 'Affiliation': 'Department of Surgery, Tohoku University Hospital.'}, {'ForeName': 'Soichiro', 'Initials': 'S', 'LastName': 'Kaneko', 'Affiliation': 'Department of Kampo Medicine.'}, {'ForeName': 'Rie', 'Initials': 'R', 'LastName': 'Ono', 'Affiliation': 'Department of Kampo Medicine.'}, {'ForeName': 'Satoko', 'Initials': 'S', 'LastName': 'Suzuki', 'Affiliation': 'Department of Kampo Medicine.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Kamei', 'Affiliation': 'Department of Surgery, Tohoku University Hospital.'}, {'ForeName': 'Tadashi', 'Initials': 'T', 'LastName': 'Ishii', 'Affiliation': 'Department of Kampo Medicine.'}]",Medicine,['10.1097/MD.0000000000020317'] 2045,32491124,Effects of dry and traditional bed bathing on respiratory parameters: a randomized pilot study.,"OBJECTIVE to compare the time for performance of dry and traditional bed bathing and its effects on transcutaneous arterial oxygen saturation and respiratory rates in critical adult patients. METHOD pilot study of a randomized, open, crossover clinical trial, performed with 15 adult critically ill patients. Each patient received a dry and a traditional bed bath. Analysis of variance with repeated measures was used, adopting p-value ≤ 0.05. RESULTS most patients were male (73.3%), white (66.7%), with a mean age of 69.7 years. The dry bath was faster (20.0 minutes) than the traditional bath (30.0 minutes) (p<0.001). There was no significant difference between the patients' saturation means between baths (p=0.381), with 94.7% for the dry bath and 95.2% for the traditional bath. During the traditional bath, the patients' respiratory rate mean was higher (24.2 incursions per minute) and statistically different (p<0.001) from the value obtained for the dry bath (20.5 incursions per minute). CONCLUSION the dry bath had a shorter duration than did the traditional bath, resulting in less patient exposure. The traditional bed bath had a negative effect on patients' respiratory rate, increasing it. Brazilian Registry of Clinical Trials (ReBEC): RBR-5qwkqd.",2020,The dry bath was faster (20.0 minutes) than the traditional bath (30.0 minutes) (p<0.001).,"['Brazilian Registry of Clinical Trials (ReBEC', 'most patients were male (73.3%), white (66.7%), with a mean age of 69.7 years', 'critical adult patients', '15 adult critically ill patients']",['dry and traditional bed bathing'],"['transcutaneous arterial oxygen saturation and respiratory rates', 'respiratory parameters', 'respiratory rate mean']","[{'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C4517843', 'cui_str': '66.7'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}]","[{'cui': 'C0011682', 'cui_str': 'Desiccation - action'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0004914', 'cui_str': 'Bedding'}, {'cui': 'C0518460', 'cui_str': 'Bathing'}]","[{'cui': 'C0428175', 'cui_str': 'Oxygen saturation measurement, arterial'}, {'cui': 'C0231832', 'cui_str': 'Respiratory rate'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",15.0,0.0337215,The dry bath was faster (20.0 minutes) than the traditional bath (30.0 minutes) (p<0.001).,"[{'ForeName': 'Luana Vieira', 'Initials': 'LV', 'LastName': 'Toledo', 'Affiliation': 'Departamento de Medicina e Enfermagem, Universidade Federal de Viçosa, Viçosa, MG, Brasil.'}, {'ForeName': 'Patrícia de Oliveira', 'Initials': 'PO', 'LastName': 'Salgado', 'Affiliation': 'Departamento de Medicina e Enfermagem, Universidade Federal de Viçosa, Viçosa, MG, Brasil.'}, {'ForeName': 'Cristiane Chaves de', 'Initials': 'CC', 'LastName': 'Souza', 'Affiliation': 'Departamento de Medicina e Enfermagem, Universidade Federal de Viçosa, Viçosa, MG, Brasil.'}, {'ForeName': 'Lídia Miranda', 'Initials': 'LM', 'LastName': 'Brinati', 'Affiliation': 'Unidade de Terapia Intensiva, Hospital São Sebastião, Viçosa, MG, Brasil.'}, {'ForeName': 'Carla de Fátima', 'Initials': 'CF', 'LastName': 'Januário', 'Affiliation': 'Departamento de Medicina e Enfermagem, Universidade Federal de Viçosa, Viçosa, MG, Brasil.'}, {'ForeName': 'Flávia Falci', 'Initials': 'FF', 'LastName': 'Ercole', 'Affiliation': 'Escola de Enfermagem, Universidade Federal de Minas Gerais, Belo Horizonte, MG, Brasil.'}]",Revista latino-americana de enfermagem,['10.1590/1518-8345.3668.3264'] 2046,32485095,"Differential effects of testosterone on circulating neutrophils, monocytes, and platelets in men: Findings from two trials.","BACKGROUND Testosterone treatment increases erythrocytes in men, but its effects on leukocyte and platelet counts are unknown and could affect its safety. OBJECTIVE To determine whether testosterone affects circulating leukocytes and platelets in men. METHODS Secondary analyses of two randomized testosterone trials were performed: the 5α-reductase (5aR) and OPTIMEN trials. In 5aR trial, 102 healthy men, 21-50 years (mean age 38), received a long-acting GnRH agonist, and 50, 125, 300, or 600 mg/week testosterone enanthate (TE) plus placebo or 2.5 mg / day dutasteride for 20 weeks. In OPTIMEN, 78 functionally limited men, ≥65 years (mean age 72) with protein intake ≤ 0.83 g kg -1  day -1 , were randomized to controlled diets with 0.8 g kg -1  day -1 protein or 1.3 g kg -1  day -1 protein plus placebo or TE (100 mg/week) for 6 months. Changes from baseline in total and differential leukocyte count, and platelet count were evaluated. RESULTS In 5aR, testosterone administration was associated with increases in total leukocyte (estimated change from baseline 40, 490, 1230, and 1280 cells/µL, P < .001), neutrophil (65.1, 436.1, 1177.2, and 1192.2 cells/µL, P < .001), monocyte (-20.2, 24.5, 90.6, and 143.9 cells/µL, P < .001), platelet (-7.3, 8.4, 8.7, and 8.9 × 10 3 cells/µL, P = .033), and erythrocyte counts. Testosterone did not affect absolute lymphocyte count. Similar increase in total leukocyte count was observed with testosterone treatment in OPTIMEN (change 0.77 × 10 3 cells/µL, P vs placebo = 0.004). CONCLUSIONS Testosterone administration in men differentially increases neutrophil and monocyte counts. These findings, together with its erythropoietic effects, suggest that testosterone promotes the differentiation of hematopoietic progenitors into the myeloid lineage. These findings have potential mechanistic, therapeutic, and safety implications.",2020,Similar increase in total leukocyte count was observed with testosterone treatment in OPTIMEN (change 0.77,"['78 functionally-limited men, ≥65 years (mean age 72) with protein intake ≤0.83 g * kg -1 * day -1', 'men', '102 healthy men, 21-50 years (mean age 38', 'Men']","['controlled diets with 0.8 g * kg -1 * day -1 protein or 1.3 g * kg -1 * day -1 protein plus placebo or TE', 'testosterone', 'Testosterone', 'enanthate (TE) plus placebo', '5α-Reductase (5aR']","['total and differential leukocyte count, and platelet count', 'monocyte', 'total leukocyte', 'total leukocyte count', 'Peripheral Neutrophils, Monocytes and Platelets', 'platelet', 'neutrophil and monocyte counts', 'absolute lymphocyte count', 'neutrophil', 'erythrocyte counts']","[{'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0743195', 'cui_str': 'Dietary control'}, {'cui': 'C4517481', 'cui_str': '0.8'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C4517499', 'cui_str': '1.3'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0039601', 'cui_str': 'Testosterone'}, {'cui': 'C0019226', 'cui_str': 'Enanthates'}, {'cui': 'C0030016', 'cui_str': 'Oxidoreductase'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0162401', 'cui_str': 'Differential white blood cell count procedure'}, {'cui': 'C0032181', 'cui_str': 'Platelet count'}, {'cui': 'C0026473', 'cui_str': 'Monocyte'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear leukocyte'}, {'cui': 'C0005821', 'cui_str': 'thrombocytes'}, {'cui': 'C0200637', 'cui_str': 'Monocyte count'}, {'cui': 'C3544087', 'cui_str': 'Absolute lymphocyte count'}, {'cui': 'C0014772', 'cui_str': 'Red blood cell count'}]",102.0,0.505029,Similar increase in total leukocyte count was observed with testosterone treatment in OPTIMEN (change 0.77,"[{'ForeName': 'Thiago', 'Initials': 'T', 'LastName': 'Gagliano-Jucá', 'Affiliation': ""Research Program in Men's Health: Aging and Metabolism, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Karol M', 'Initials': 'KM', 'LastName': 'Pencina', 'Affiliation': ""Research Program in Men's Health: Aging and Metabolism, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Guo', 'Affiliation': ""Research Program in Men's Health: Aging and Metabolism, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Zhuoying', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': ""Research Program in Men's Health: Aging and Metabolism, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Grace', 'Initials': 'G', 'LastName': 'Huang', 'Affiliation': ""Research Program in Men's Health: Aging and Metabolism, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Shehzad', 'Initials': 'S', 'LastName': 'Basaria', 'Affiliation': ""Research Program in Men's Health: Aging and Metabolism, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Shalender', 'Initials': 'S', 'LastName': 'Bhasin', 'Affiliation': ""Research Program in Men's Health: Aging and Metabolism, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}]",Andrology,['10.1111/andr.12834'] 2047,32485656,Impulsiveness as a moderator of amphetamine treatment response for cocaine use disorder among ADHD patients.,"BACKGROUND Amphetamines are a first-line treatment for ADHD and have shown promise for the treatment of cocaine use disorder (CUD), both alone and with comorbid ADHD. Impulsiveness is a key aspect of both ADHD and substance use disorders. We sought to understand the role of baseline impulsiveness in the treatment of comorbid CUD and ADHD. METHODS In a post hoc analysis (N = 76) of a 14-week, double-blind, randomized, placebo-controlled trial of mixed amphetamine salts-extended release (MAS-ER) for comorbid ADHD and CUD, we examined the relationship between treatment response and participants' baseline Barratt Impulsiveness Scale (BIS-11) score by comparing those with scores below versus above the median. In the original trial, participants received daily 60 mg MAS-ER, 80 mg MAS-ER, or placebo, in conjunction with cognitive behavioral therapy. RESULTS The odds of a cocaine-abstinent week over time were significantly greater in the high BIS group compared to the low BIS group, both when missing data was treated as missing (p = .0155; OR = 1.23, 95% CI: 1.13, 1.35 versus OR = 1.04, 95% CI: 0.95, 1.15) and when missing data was treated as cocaine-positive (p = .003; OR = 1.15, 95% CI: 1.06, 1.24 versus OR = 0.96, 95% CI: 0.88, 1.05). CONCLUSIONS The results show an association between higher within-group trait impulsiveness, as measured by the BIS-11, and response to MAS-ER for CUD in a cohort with comorbid ADHD. This result further demonstrates that impulsiveness is an important factor when considering treatment options for patients with CUD and that higher baseline impulsiveness may predict response to treatment with psychostimulants for CUD.",2020,"The odds of a cocaine-abstinent week over time were significantly greater in the high BIS group compared to the low BIS group, both when missing data was treated as missing (p = .0155; OR = 1.23, 95% CI: 1.13, 1.35 versus OR = 1.04, 95% CI: 0.95, 1.15) and when missing data was treated as cocaine-positive (p = .003; OR = 1.15, 95% CI: 1.06, 1.24 versus OR = 0.96, 95% CI: 0.88, 1.05). ","['ADHD patients', 'patients with CUD']","['mixed amphetamine salts-extended release (MAS-ER', 'daily 60\u2009mg MAS-ER, 80\u2009mg\u2009MAS-ER, or placebo, in conjunction with cognitive behavioral therapy', 'amphetamine', 'placebo']",['baseline Barratt Impulsiveness Scale (BIS-11) score'],"[{'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009170', 'cui_str': 'Cocaine'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0002658', 'cui_str': 'Amphetamine'}, {'cui': 'C0036140', 'cui_str': 'Salts'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0564567', 'cui_str': 'Impulsive character'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0053723', 'cui_str': 'bis(cyclohexylammonium)'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.145481,"The odds of a cocaine-abstinent week over time were significantly greater in the high BIS group compared to the low BIS group, both when missing data was treated as missing (p = .0155; OR = 1.23, 95% CI: 1.13, 1.35 versus OR = 1.04, 95% CI: 0.95, 1.15) and when missing data was treated as cocaine-positive (p = .003; OR = 1.15, 95% CI: 1.06, 1.24 versus OR = 0.96, 95% CI: 0.88, 1.05). ","[{'ForeName': 'Derek', 'Initials': 'D', 'LastName': 'Blevins', 'Affiliation': 'Department of Psychiatry, Columbia University Irving Medical Center, New York, NY, United States; Division on Substance Use Disorders, New York State Psychiatric Institute, New York, NY, United States. Electronic address: derek.blevins@nyspi.columbia.edu.'}, {'ForeName': 'C Jean', 'Initials': 'CJ', 'LastName': 'Choi', 'Affiliation': 'Mental Health Data Science, New York State Psychiatric Institute, New York, NY, United States.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Pavlicova', 'Affiliation': 'Department of Biostatistics, Columbia University Mailman School of Public Health, New York, NY, United States.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Martinez', 'Affiliation': 'Department of Psychiatry, Columbia University Irving Medical Center, New York, NY, United States; Division on Substance Use Disorders, New York State Psychiatric Institute, New York, NY, United States.'}, {'ForeName': 'John J', 'Initials': 'JJ', 'LastName': 'Mariani', 'Affiliation': 'Department of Psychiatry, Columbia University Irving Medical Center, New York, NY, United States; Division on Substance Use Disorders, New York State Psychiatric Institute, New York, NY, United States.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Grabowski', 'Affiliation': 'Department of Psychiatry, University of Minnesota Twin Cities, Minneapolis, MN, United States.'}, {'ForeName': 'Frances R', 'Initials': 'FR', 'LastName': 'Levin', 'Affiliation': 'Department of Psychiatry, Columbia University Irving Medical Center, New York, NY, United States; Division on Substance Use Disorders, New York State Psychiatric Institute, New York, NY, United States.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2020.108082'] 2048,32485741,"Response to Letter to the Editor: ""Twice as High Diet-Induced Thermogenesis After Breakfast vs Dinner on High-Calorie as well as Low-Calorie Meals"".",,2020,,[],[],[],[],[],[],,0.0162441,,"[{'ForeName': 'Juliane', 'Initials': 'J', 'LastName': 'Richter', 'Affiliation': 'Section of Psychoneurobiology, Center of Brain, Behavior and Metabolism, University of Luebeck, Luebeck, Germany.'}, {'ForeName': 'Kerstin M', 'Initials': 'KM', 'LastName': 'Oltmanns', 'Affiliation': 'Section of Psychoneurobiology, Center of Brain, Behavior and Metabolism, University of Luebeck, Luebeck, Germany.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgaa353'] 2049,32591590,Effects of combining constraint-induced movement therapy and action-observation training on upper limb kinematics in children with unilateral cerebral palsy: a randomized controlled trial.,"Modified constraint-induced movement therapy (mCIMT) improves upper limb (UL) motor execution in unilateral cerebral palsy (uCP). As these children also show motor planning deficits, action-observation training (AOT) might be of additional value. Here, we investigated the combined value of AOT to mCIMT on UL kinematics in children with uCP in a randomized controlled trial. Thirty-six children with uCP completed an UL kinematic and clinical evaluation after participating in a 9-day mCIMT camp wearing a splint for 6 h/day. The experimental group (mCIMT + AOT, n = 20) received 15 h of AOT, i.e. video-observation and execution of unimanual tasks. The control group (mCIMT + placebo, n = 16) watched biological-motion free videos and executed the same tasks. We examined changes in motor control (movement duration, peak velocity, time-to-peak velocity, and trajectory straightness) and kinematic movement patterns (using Statistical Parametric Mapping) during the execution of three unimanual, relevant tasks before the intervention, after and at 6 months follow-up. Adding AOT to mCIMT mainly affected movement duration during reaching, whereas little benefit is seen on UL movement patterns. mCIMT, with or without AOT, improved peak velocity and trajectory straightness, and proximal movement patterns. Clinical and kinematic improvements are poorly related. Although there seem to be limited benefits of AOT to CIMT on UL kinematics, our results support the inclusion of kinematics to capture changes in motor control and movement patterns of the proximal joints.",2020,"The control group (mCIMT + placebo, n = 16) watched biological-motion free videos and executed the same tasks.","['children with unilateral cerebral palsy', 'children with uCP', 'unilateral cerebral palsy (uCP', 'Thirty-six children with uCP completed an UL kinematic and clinical evaluation after participating in a 9-day mCIMT camp wearing a splint for 6\xa0h/day']","['15\xa0h of AOT, i.e. video-observation and execution of unimanual tasks', 'control group (mCIMT\u2009+\u2009placebo, n\u2009=\u200916) watched biological-motion free videos and executed the same tasks', 'combining constraint-induced movement therapy and action-observation training', 'AOT to mCIMT', 'Modified constraint-induced movement therapy (mCIMT']","['peak velocity and trajectory straightness, and proximal movement patterns', 'motor control (movement duration, peak velocity, time-to-peak velocity, and trajectory straightness) and kinematic movement patterns', 'upper limb kinematics', 'upper limb (UL) motor execution']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0007789', 'cui_str': 'Cerebral palsy'}, {'cui': 'C4319606', 'cui_str': '36'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}, {'cui': 'C1261322', 'cui_str': 'Evaluation procedure'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0454279', 'cui_str': 'Movement therapy'}, {'cui': 'C0001455', 'cui_str': 'Cyclic AMP'}, {'cui': 'C0038009', 'cui_str': 'Splint'}]","[{'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C1278561', 'cui_str': 'Judicial execution'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0454279', 'cui_str': 'Movement therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0005515', 'cui_str': 'Biological agent'}, {'cui': 'C0026597', 'cui_str': 'Motion'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0205107', 'cui_str': 'Proximal'}, {'cui': 'C0427096', 'cui_str': 'Patterning of movement'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C1278561', 'cui_str': 'Judicial execution'}]",36.0,0.0555808,"The control group (mCIMT + placebo, n = 16) watched biological-motion free videos and executed the same tasks.","[{'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Simon-Martinez', 'Affiliation': 'Department of Rehabilitation Sciences, KU Leuven, 3000, Leuven, Belgium. cristina.simon@kuleuven.be.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Mailleux', 'Affiliation': 'Department of Rehabilitation Sciences, KU Leuven, 3000, Leuven, Belgium.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Jaspers', 'Affiliation': 'Neural Control of Movement Lab, ETH Zurich, Zurich, Switzerland.'}, {'ForeName': 'Els', 'Initials': 'E', 'LastName': 'Ortibus', 'Affiliation': 'Department of Development and Regeneration, KU Leuven, Leuven, Belgium.'}, {'ForeName': 'Kaat', 'Initials': 'K', 'LastName': 'Desloovere', 'Affiliation': 'Department of Rehabilitation Sciences, KU Leuven, 3000, Leuven, Belgium.'}, {'ForeName': 'Katrijn', 'Initials': 'K', 'LastName': 'Klingels', 'Affiliation': 'Department of Rehabilitation Sciences, KU Leuven, 3000, Leuven, Belgium.'}, {'ForeName': 'Hilde', 'Initials': 'H', 'LastName': 'Feys', 'Affiliation': 'Department of Rehabilitation Sciences, KU Leuven, 3000, Leuven, Belgium.'}]",Scientific reports,['10.1038/s41598-020-67427-2'] 2050,32591594,Cold atmospheric plasma as an effective method to treat diabetic foot ulcers: A randomized clinical trial.,"Cold atmospheric plasma (CAP) was shown to decrease bacterial load in chronic wounds. It was also presented as a novel approach to healing wounds in both in vitro and in vivo experiments. We aimed to examine the first randomized clinical trial for the use of CAP in diabetic foot ulcers. Patients (n = 44) were randomly double-blinded, and assigned to receive standard care (SC, n = 22) without or with CAP, to be applied three times a week for three consecutive weeks (SC + CAP, n = 22), using block randomization with mixing block sizes of four. The trial was conducted at the Diabetes Research Center in Tehran, Iran. CAP was generated from ionized helium gas in ambient air, and driven by a high voltage (10 kV) and high frequency (6 kHz) power supply. Primary outcomes were wound size, number of cases reaching wound size of <0.5, and a bacterial load after over three weeks of treatment. CAP treatment effectively reduced the fraction of wound size (p = 0.02). After three weeks, the wounds to reach fraction wound size of ≤0.5 was significantly greater in the SC + CAP group (77.3%) compared to the SC group (36.4%) (p = 0.006). The mean fraction of bacterial load counted in each session 'after CAP exposure' was significantly less than 'before exposure' measures. CAP can be an efficient method to accelerate wound healing in diabetic foot ulcers, with immediate antiseptic effects that do not seem to last long.",2020,The mean fraction of bacterial load counted in each session 'after CAP exposure' was significantly less than 'before exposure' measures.,"['Diabetes Research Center in Tehran, Iran', 'diabetic foot ulcers', 'Patients (n\u2009=\u200944']","['Cold atmospheric plasma (CAP', 'Cold atmospheric plasma', 'CAP', 'standard care (SC, n\u2009=\u200922) without or with CAP']","['mean fraction of bacterial load', 'wound size, number of cases reaching wound size of <0.5, and a bacterial load', 'fraction of wound size']","[{'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C1456868', 'cui_str': 'Diabetic foot ulcer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0009264', 'cui_str': 'Low temperature'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C2936404', 'cui_str': 'Bacterial Load'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0444500', 'cui_str': '0.5'}]",44.0,0.0759249,The mean fraction of bacterial load counted in each session 'after CAP exposure' was significantly less than 'before exposure' measures.,"[{'ForeName': 'Shahriar', 'Initials': 'S', 'LastName': 'Mirpour', 'Affiliation': 'Department of Applied physics, Eindhoven university of Technology, Eindhoven, The Netherlands.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Fathollah', 'Affiliation': 'Department of Applied physics, Amirkabir university of Technology, Tehran, Iran.'}, {'ForeName': 'Parvin', 'Initials': 'P', 'LastName': 'Mansouri', 'Affiliation': 'Skin and Stem Cell Research Center, Tehran University of Medical Sciences, Tehran, Iran. mansorip@sina.tums.ac.ir.'}, {'ForeName': 'Bagher', 'Initials': 'B', 'LastName': 'Larijani', 'Affiliation': 'Endocrinology and Metabolism Research Center, Endocrinology and Metabolism Clinical Sciences Institute, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mahmood', 'Initials': 'M', 'LastName': 'Ghoranneviss', 'Affiliation': 'Endocrinology and Metabolism Research Center, Endocrinology and Metabolism Clinical Sciences Institute, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohammadreza', 'Initials': 'M', 'LastName': 'Mohajeri Tehrani', 'Affiliation': 'Endocrinology and Metabolism Research Center, Endocrinology and Metabolism Clinical Sciences Institute, Tehran University of Medical Sciences, Tehran, Iran. mrmohajeri@tums.ac.ir.'}, {'ForeName': 'Mohammad Reza', 'Initials': 'MR', 'LastName': 'Amini', 'Affiliation': 'Diabetes Research Center, Endocrinology and Metabolism Clinical Sciences Institute, Tehran University of Medical Sciences, Tehran, Iran. mramini@tums.ac.ir.'}]",Scientific reports,['10.1038/s41598-020-67232-x'] 2051,32592830,Cluster-sets resistance training induce similar functional and strength improvements than the traditional method in postmenopausal and elderly women.,"OBJECTIVE The aim of this study was to compare the effects of 12 weeks of traditional resistance training (TRT) or resistance training using Cluster-set (CS) on functional performance and physical fitness of postmenopausal and elderly women. METHODS Participants (61.1 ± 4.9 years, body mass 64.5 ± 1.8 kg, height 155.7 ± 4.7 cm) were randomized to TRT (n = 35) or CS (n = 31). Anthropometric measures, muscle strength and power, gait speed, core stability, flexibility, and functional performance tests were performed before and after 12 weeks of training. The difference between protocols was the structure of rest intervals. The TRT group performed 120 s of rest between sets of 8 repetitions, while the CS performed 30 s of rest after every 2 repetitions. Two-way ANOVA with repeated measures was applied for each variable and, when needed, the Bonferroni post hoc was used. Statistical significance was set at p < 0.05. RESULTS No group by time interaction was found for any variable. Regarding between-moment comparisons, there were significant improvements for 1 repetition maximum (RM) bench press (F = 104.6; η p 2  = 0.62; p < 0.001), 1RM leg press (F = 74.6; η p 2  = 0.53; p < 0.001), medicine ball throw (F = 64.0; η p 2  = 0.26; p < 0.001), standing long jump (F = 27.6; η p 2  = 0.30; p < 0.001), countermovement jump (F = 17.4; η p 2  = 0.21; p < 0.001), squat jump (F = 23.2; η p 2  = 0.26; p < 0.001), plank time (F = 31.6; η p 2  = 0.33; p < 0.001), 6 m walking test (F = 18.0; η p 2  = 0.22; p < 0.001), sit-to-stand test (F = 20.4; η p 2  = 0.24; p < 0.001), sit and reach test (F = 56.8; η p 2  = 0.47; p < 0.001) and 2 kg elbow curls (F = 15.9; η p 2  = 0.19; p < 0.001). CONCLUSION Considering that both CS and TRT methods were equally effective to improve the physical fitness and functionality of elderly women, the decision of which protocol to use should be based on individual preferences and practical aspects.",2020,"Regarding between-moment comparisons, there were significant improvements for 1 repetition maximum (RM) bench press (F = 104.6; η p 2  = 0.62; p < 0.001), 1RM leg press (F = 74.6; η p 2  = 0.53; p < 0.001), medicine ball throw (F = 64.0; η p 2  = 0.26; p < 0.001), standing long jump (F = 27.6; η p 2  = 0.30; p < 0.001), countermovement jump (F = 17.4; η p 2  = 0.21; p < 0.001), squat jump (F = 23.2; η p 2  = 0.26; p < 0.001), plank time (F = 31.6; η p 2  = 0.33; p < 0.001), 6 m walking test (F = 18.0; η p 2  = 0.22; p < 0.001), sit-to-stand test (F = 20.4; η p 2  = 0.24; p < 0.001), sit and reach test (F = 56.8; η p 2  = 0.47; p < 0.001) and 2 kg elbow curls (F = 15.9; η p 2  = 0.19; p < 0.001). ","['Participants (61.1\u202f±\u202f4.9\u202fyears, body mass 64.5\u202f±\u202f1.8\u202fkg, height 155.7\u202f±\u202f4.7\u202fcm', 'postmenopausal and elderly women', 'elderly women']","['traditional resistance training (TRT) or resistance training using Cluster-set (CS', 'CS', 'Cluster-sets resistance training', 'TRT']","['Anthropometric measures, muscle strength and power, gait speed, core stability, flexibility, and functional performance tests', 'countermovement jump', '1 repetition maximum (RM) bench press', '1RM leg press', 'standing long jump', 'plank time', 'functional performance and physical fitness', 'squat jump']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C4068742', 'cui_str': '1.8'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0524338', 'cui_str': 'Elderly woman'}]","[{'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}]","[{'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0454326', 'cui_str': 'Bench press'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0241236', 'cui_str': 'Does squat'}]",,0.024454,"Regarding between-moment comparisons, there were significant improvements for 1 repetition maximum (RM) bench press (F = 104.6; η p 2  = 0.62; p < 0.001), 1RM leg press (F = 74.6; η p 2  = 0.53; p < 0.001), medicine ball throw (F = 64.0; η p 2  = 0.26; p < 0.001), standing long jump (F = 27.6; η p 2  = 0.30; p < 0.001), countermovement jump (F = 17.4; η p 2  = 0.21; p < 0.001), squat jump (F = 23.2; η p 2  = 0.26; p < 0.001), plank time (F = 31.6; η p 2  = 0.33; p < 0.001), 6 m walking test (F = 18.0; η p 2  = 0.22; p < 0.001), sit-to-stand test (F = 20.4; η p 2  = 0.24; p < 0.001), sit and reach test (F = 56.8; η p 2  = 0.47; p < 0.001) and 2 kg elbow curls (F = 15.9; η p 2  = 0.19; p < 0.001). ","[{'ForeName': 'Rayra Khalinka Neves', 'Initials': 'RKN', 'LastName': 'Dias', 'Affiliation': 'Faculdade de Educação Física, Universidade Federal do Pará, Castanhal, PA, Brasil.'}, {'ForeName': 'Eduardo Macedo', 'Initials': 'EM', 'LastName': 'Penna', 'Affiliation': 'Faculdade de Educação Física, Universidade Federal do Pará, Castanhal, PA, Brasil; Programa de Pós Graduação em Ciências do Movimento Humano, Universidade Federal do Pará.'}, {'ForeName': 'Adria Samara Negrão', 'Initials': 'ASN', 'LastName': 'Noronha', 'Affiliation': 'Faculdade de Educação Física, Universidade Federal do Pará, Castanhal, PA, Brasil.'}, {'ForeName': 'Antenor Barbosa Calandrini', 'Initials': 'ABC', 'LastName': 'de Azevedo', 'Affiliation': 'Faculdade de Educação Física, Universidade Federal do Pará, Castanhal, PA, Brasil.'}, {'ForeName': 'Matheus', 'Initials': 'M', 'LastName': 'Barbalho', 'Affiliation': 'Faculdade de Educação Física e Dança, Universidade Federal de Goiás, Goiânia, GO, Brasil.'}, {'ForeName': 'Paulo Viana', 'Initials': 'PV', 'LastName': 'Gentil', 'Affiliation': 'Faculdade de Educação Física e Dança, Universidade Federal de Goiás, Goiânia, GO, Brasil.'}, {'ForeName': 'Victor Silveira', 'Initials': 'VS', 'LastName': 'Coswig', 'Affiliation': 'Faculdade de Educação Física, Universidade Federal do Pará, Castanhal, PA, Brasil; Programa de Pós Graduação em Ciências do Movimento Humano, Universidade Federal do Pará. Electronic address: vcoswig@ufpa.br.'}]",Experimental gerontology,['10.1016/j.exger.2020.111011'] 2052,32592861,"Antidepressant efficacy and immune effects of bilateral theta burst stimulation monotherapy in major depression: A randomized, double-blind, sham-controlled study.",,2020,,['Major Depression'],['Bilateral Theta Burst Stimulation Monotherapy'],[],"[{'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}]","[{'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}]",[],,0.446696,,"[{'ForeName': 'Po-Han', 'Initials': 'PH', 'LastName': 'Chou', 'Affiliation': 'Department of Psychiatry, China Medical University Hsinchu Hospital, China Medical University, Hsinchu, Taiwan; Department of Psychiatry, China Medical University Hospital, China Medical University, Taichung, Taiwan; Department of Biological Science and Technology, National Chiao Tung University, Hsinchu, Taiwan; Taiwan Allied Clinics for Integrative TMS, Taipei, Taiwan.'}, {'ForeName': 'Ming-Kuei', 'Initials': 'MK', 'LastName': 'Lu', 'Affiliation': 'Department of Neurology, China Medical University Hospital, Taichung, Taiwan; College of Medicine, China Medical University, Taichung, Taiwan.'}, {'ForeName': 'Chon-Haw', 'Initials': 'CH', 'LastName': 'Tsai', 'Affiliation': 'Department of Neurology, China Medical University Hospital, Taichung, Taiwan; College of Medicine, China Medical University, Taichung, Taiwan.'}, {'ForeName': 'Wan-Ting', 'Initials': 'WT', 'LastName': 'Hsieh', 'Affiliation': 'Mind-Body Interface Laboratory (MBI-Lab), China Medical University Hospital, Taichung, Taiwan.'}, {'ForeName': 'Hui-Chen', 'Initials': 'HC', 'LastName': 'Lai', 'Affiliation': 'Mind-Body Interface Laboratory (MBI-Lab), China Medical University Hospital, Taichung, Taiwan.'}, {'ForeName': 'Sergey', 'Initials': 'S', 'LastName': 'Shityakov', 'Affiliation': 'Department of Psychiatry, China Medical University Hospital, China Medical University, Taichung, Taiwan; College of Medicine, China Medical University, Taichung, Taiwan; Mind-Body Interface Laboratory (MBI-Lab), China Medical University Hospital, Taichung, Taiwan.'}, {'ForeName': 'Kuan-Pin', 'Initials': 'KP', 'LastName': 'Su', 'Affiliation': 'Department of Psychiatry, China Medical University Hospital, China Medical University, Taichung, Taiwan; College of Medicine, China Medical University, Taichung, Taiwan; Mind-Body Interface Laboratory (MBI-Lab), China Medical University Hospital, Taichung, Taiwan; An-Nan Hospital, China Medical University, Tainan, Taiwan. Electronic address: cobolsu@gmail.com.'}]","Brain, behavior, and immunity",['10.1016/j.bbi.2020.06.024'] 2053,32593046,"An open-label, multicentre, randomized comparative study of efficacy, safety and tolerability of the 5 plant - extract BNO 1012 in the Delayed Antibiotic Prescription Method in children, aged 6 to 11 years with acute viral and post-viral rhinosinusitis.","Acute rhinosinusitis (ARS) can be characterized as bacterial (ABRS) and require antibiotic therapy only in 0.5-5% of cases. In most cases, the disease is in a viral and post-viral form, which requires pathogenetic and symptomatic treatment. The study objective was to determine the efficacy of BNO 1012 extract in the technology of delayed antibiotic prescribing in children with acute rhinosinusitis. METHODS 292 children aged 6 to 11 years with ARS were randomized in the multicenter, comparative study. They received an extract of five medicinal plants in addition to standard symptomatic therapy or standard therapy only. EVALUATION CRITERIA: reduction of the sinusitis severity according to a 4-point medical assessment scale (nasal congestion, severity of anterior and posterior rhinorrhea) at each visit, dynamics of self-scoring of rhinorrhea and headache (according to a 10-point visual analogue scale), ""therapeutic benefit"" in days, frequency of antibiotic prescriptions due to the use of an extract of five plants. RESULTS The use of the 5-plant extract BNO 1012 in addition to the standard symptomatic treatment of acute rhinosinusitis provides a clinically significant, adequate reduction in the severity of rhinorrhea, nasal congestion and post-nasal drip, assessed by a physician at V2 (p < 0.005). Significant differences are noted in the patient's self-scoring of rhinorrhea on the second or third day in viral RS, and from the fourth to the eighth day in post-viral RS. Symptoms of similar intensity in control group were observed at V3. Thus, in the first week of treatment, the treatment group compared to the control one showed a ""therapeutic benefit"" of three days. The use of BNO 1012 in patients with acute rhinosinusitis can 1.81-fold reduce the prescription of antibacterial drugs. CONCLUSION The combination of five medicinal plants is effective for the treatment of acute rhinosinusitis in children aged 6 to 11 years. Its use provides a significant ""therapeutic benefit"" when administered in addition to standard symptomatic therapy, reducing the need for antibiotic use.",2020,The combination of five medicinal plants is effective for the treatment of acute rhinosinusitis in children aged 6 to 11 years.,"['children, aged 6 to 11\u202fyears with acute viral and post-viral rhinosinusitis', '292 children aged 6 to 11\u202fyears with ARS', 'children with acute rhinosinusitis', 'Acute rhinosinusitis (ARS', 'patients with acute rhinosinusitis', 'acute rhinosinusitis in children aged 6 to 11\u202fyears']",['5 plant - extract BNO'],"['efficacy, safety and tolerability', ""patient's self-scoring of rhinorrhea"", 'severity of rhinorrhea, nasal congestion and post-nasal drip']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0032081', 'cui_str': 'Plant extract'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1260880', 'cui_str': 'Nasal discharge'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0027424', 'cui_str': 'Nasal congestion'}, {'cui': 'C0032781', 'cui_str': 'Posterior rhinorrhea'}]",292.0,0.0255448,The combination of five medicinal plants is effective for the treatment of acute rhinosinusitis in children aged 6 to 11 years.,"[{'ForeName': 'Vasyl I', 'Initials': 'VI', 'LastName': 'Popovych', 'Affiliation': 'ENT - Department of Ivano-Frankivsk National Medical University, Halytska Street, 2, Ivano-Frankivsk, Ivano-Frankivsk Region 76000, Ukraine. Electronic address: popovych_ent@ukr.net.'}, {'ForeName': 'Halyna V', 'Initials': 'HV', 'LastName': 'Beketova', 'Affiliation': 'Department of Children and Adolescent Diseases of the National Academy of Postgraduate Education, 9, Dorogozhytska Street, Kyiv 04112, Ukraine.'}, {'ForeName': 'Ivana V', 'Initials': 'IV', 'LastName': 'Koshel', 'Affiliation': 'Department of Therapy and Family Medicine of Institute of Postgraduate Education of Ivano-Frankivsk National Medical University, Ivano-Frankivsk, Halytska Street, 2, Ivano-Frankivsk, Ivano-Frankivsk Region 76000, Ukraine.'}, {'ForeName': 'Olha A', 'Initials': 'OA', 'LastName': 'Tsodikova', 'Affiliation': 'Department of Outpatient Pediatrics KhMAPE, 58 Amosova Street, Kharkiv, Kharkiv Region 61176, Ukraine.'}, {'ForeName': 'Tetiana A', 'Initials': 'TA', 'LastName': 'Kriuchko', 'Affiliation': 'Department of Pediatrics №2 of Ukrainian Dental Academy, European Street, 39, Poltava, Poltava Region 36011, Ukraine.'}, {'ForeName': 'Aleksandr E', 'Initials': 'AE', 'LastName': 'Abaturov', 'Affiliation': 'Department of Pediatrics and Medical Genetics of Dnipropetrovsk Medical Academy, Volodymyra Vernadskoho Street, 9, Dnipro, Dnipropetrovsk Region 49044, Ukraine.'}, {'ForeName': 'Liudmyla I', 'Initials': 'LI', 'LastName': 'Vakulenko', 'Affiliation': 'Department of Pediatrics No. 2, Dnipropetrovsk Medical Academy, Volodymyra Vernadskoho Street, 9, Dnipro, Dnipropetrovsk Region 49044, Ukraine.'}, {'ForeName': 'Iurii V', 'Initials': 'IV', 'LastName': 'Gavrylenko', 'Affiliation': 'Department of Pediatric Otolaryngology of the National Academy of the Postgraduate Education, 9, Dorogozhytska Street, Kyiv 04112, Ukraine.'}]",American journal of otolaryngology,['10.1016/j.amjoto.2020.102564'] 2054,32593069,Affective responses to climbing exercises in children and adolescents during in-patient treatment for mental health disorders a pilot study on acute effects of different exercise interventions.,"The aim of the present study was to compare acute effects of a climbing intervention (CI) on affective responses with a different exercise intervention (swimming, SI) and an occupational therapy intervention (OTI) in children and adolescents during in-patient treatment for mental health disorders. The following study was designed as a cross-over study. Participants completed three single 60 min interventions of CI, SI and OTI. Affective responses were assessed pre and post intervention and at 20 and 40 min during intervention. The sample consisted of 33 children and adolescents in mental-health inpatient care (ᴓage: 13.3 ± 2.2 years, ♀=39.4%). A significant time effect was seen in all interventions in increasing positive and reducing negative affect, p<.028, eta²>0.144. Repeated measures ANOVAs revealed a significant time by intervention effect for affective valence (p=.011, eta²=0.09), but not for perceived activation, favouring CI over SI and OCT between pre-test and the first 20 or 40 min, respectively. All interventions showed similar effects on affective responses pre to post interventions. CI seems to increase affective valence more strongly during intervention compared to SI and OTI. The present results may have implications for therapy adherence and acute emotion regulation in children and adolescent in-patients with mental health disorders.",2020,"A significant time effect was seen in all interventions in increasing positive and reducing negative affect, p<.028, eta²>0.144.","['children and adolescent in-patients with mental health disorders', '33 children and adolescents in mental-health inpatient care (ᴓage: 13.3\xa0±\xa02.2 years, ♀=39.4', 'children and adolescents during in-patient treatment for mental health disorders']","['exercise intervention (swimming, SI) and an occupational therapy intervention (OTI', 'exercise interventions', 'climbing exercises', 'climbing intervention (CI']","['perceived activation, favouring CI over SI and OCT', 'affective valence', 'Affective responses']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C4517629', 'cui_str': '2.2'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0039003', 'cui_str': 'Swimming'}, {'cui': 'C1318464', 'cui_str': 'Occupational therapy'}, {'cui': 'C0561942', 'cui_str': 'Does climb'}]","[{'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0561942', 'cui_str': 'Does climb'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0029279', 'cui_str': 'Ornithine carbamoyltransferase'}]",33.0,0.0311106,"A significant time effect was seen in all interventions in increasing positive and reducing negative affect, p<.028, eta²>0.144.","[{'ForeName': 'Anika', 'Initials': 'A', 'LastName': 'Frühauf', 'Affiliation': 'Department of Sport Science, University of Innsbruck, Fürstenweg 185, 6020 Innsbruck, Austria. Electronic address: anika.fruehauf@uibk.ac.at.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Niedermeier', 'Affiliation': 'Department of Sport Science, University of Innsbruck, Fürstenweg 185, 6020 Innsbruck, Austria.'}, {'ForeName': 'Kathrin', 'Initials': 'K', 'LastName': 'Sevecke', 'Affiliation': 'Department of Psychiatry Psychotherapy and Psychosomatics in childhood and adolescence, Medical University of Innsbruck, Austria.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Haid-Stecher', 'Affiliation': 'Department of Psychiatry Psychotherapy and Psychosomatics in childhood and adolescence, Medical University of Innsbruck, Austria.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Albertini', 'Affiliation': 'Department of Sport Science, University of Innsbruck, Fürstenweg 185, 6020 Innsbruck, Austria.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Richter', 'Affiliation': 'Department of Sport Science, University of Innsbruck, Fürstenweg 185, 6020 Innsbruck, Austria.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Schipflinger', 'Affiliation': 'Department of Sport Science, University of Innsbruck, Fürstenweg 185, 6020 Innsbruck, Austria.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Kopp', 'Affiliation': 'Department of Sport Science, University of Innsbruck, Fürstenweg 185, 6020 Innsbruck, Austria.'}]",Psychiatry research,['10.1016/j.psychres.2020.113245'] 2055,32593123,Quality of life changes in response to yoga therapy in patients with schizophrenia: Reanalysis of Three randomized controlled trials.,,2020,,['patients with schizophrenia'],['yoga therapy'],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}]","[{'cui': 'C1883583', 'cui_str': 'Yoga'}]",[],,0.0595902,,"[{'ForeName': 'Saeko', 'Initials': 'S', 'LastName': 'Ikai-Tani', 'Affiliation': 'Department of Neuropsychiatry, Keio University School of Medicine, 35 Shinanomachi, Shinjuku-ku, 160-8582 Tokyo, Japan; Faculty of Kinesiology & Physical Education, University of Toronto, 55 Harbord Street, M5S 2W6, Toronto, ON, Canada. Electronic address: sako0609@gmail.com.'}, {'ForeName': 'Hideaki', 'Initials': 'H', 'LastName': 'Tani', 'Affiliation': 'Department of Neuropsychiatry, Keio University School of Medicine, 35 Shinanomachi, Shinjuku-ku, 160-8582 Tokyo, Japan; Kimel Family Translational Imaging-Genetics Laboratory, Centre for Addiction and Mental Health, 1001 Queen St W, M6J 1H4, Toronto, ON, Canada.'}, {'ForeName': 'Saki', 'Initials': 'S', 'LastName': 'Kamiyama', 'Affiliation': 'Department of Neuropsychiatry, Keio University School of Medicine, 35 Shinanomachi, Shinjuku-ku, 160-8582 Tokyo, Japan.'}, {'ForeName': 'Masaru', 'Initials': 'M', 'LastName': 'Mimura', 'Affiliation': 'Department of Neuropsychiatry, Keio University School of Medicine, 35 Shinanomachi, Shinjuku-ku, 160-8582 Tokyo, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Uchida', 'Affiliation': 'Department of Neuropsychiatry, Keio University School of Medicine, 35 Shinanomachi, Shinjuku-ku, 160-8582 Tokyo, Japan; Geriatric Mental Health Program, Centre for Addiction and Mental Health, 1001 Queen St W, M6J 1H4, Toronto, ON, Canada.'}]",Asian journal of psychiatry,['10.1016/j.ajp.2020.102250'] 2056,32593154,Alpha-tACS effect on inhibitory control and feasibility of administration in community outpatient substance use treatment.,"BACKGROUND Deficits in inhibitory control (IC) and distress tolerance (DT) are associated with substance use disorders (SUD) and post-treatment return to substance use. Transcranial alternating current stimulation (tACS) modulates the neural oscillations that are associated with the cognitive and affective mechanisms contributing to IC and DT. The aims of the current study were to examine the feasibility and acceptability of administering tACS in a community-based SUD treatment setting, and to test the effect of alpha-tACS on IC and DT. METHOD A double-blind, randomized, active sham-controlled trial of treatment-seeking adults with a SUD (N = 30, Mean age = 43.2 years, 70.0% male). Participants attended two sessions and completed computerized inhibitory control and distress tolerance tasks while receiving tACS targeting the bilateral dorsolateral prefrontal cortex (DLPFC). Participants received sham-tACS and were then randomized to receive sham-, alpha-, or gamma-tACS within 2-3 days. RESULTS Treatment retention was 87%. Participant self-reported belief of having received tACS and mean side effect intensity ratings did not differ across conditions, with all side effect ratings in the absent to mild range. There was a large (d = 0.83) and significant effect of alpha-tACS on inhibitory control compared to sham-tACS (β = 1.78, SE = 0.65, 95 % CI: 0.41, 3.14, p<0.01). There were no significant effects of condition on distress tolerance. CONCLUSIONS To our knowledge, this is the first study of tACS in adults with a SUD. Our findings provide preliminary evidence for recruitment, retention, and administration feasibility of tACS in a community-based substance use treatment program and a beneficial effect of alpha-tACS on inhibitory control.",2020,Transcranial alternating current stimulation (tACS) modulates the neural oscillations that are associated with the cognitive and affective mechanisms contributing to IC and DT.,"['treatment-seeking adults with a SUD (N = 30, Mean age = 43.2 years, 70.0% male', 'adults with a SUD']","['Transcranial alternating current stimulation (tACS', 'sham-, alpha-, or gamma-tACS', 'alpha-tACS', 'tACS', 'sham-tACS', 'computerized inhibitory control and distress tolerance tasks while receiving tACS']","['feasibility and acceptability', 'distress tolerance']","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0038586', 'cui_str': 'Substance use disorder'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C3852966', 'cui_str': 'Transcranial Alternating Current Stimulation'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0017011', 'cui_str': 'Gamma radiation'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}]",,0.0861259,Transcranial alternating current stimulation (tACS) modulates the neural oscillations that are associated with the cognitive and affective mechanisms contributing to IC and DT.,"[{'ForeName': 'Stacey B', 'Initials': 'SB', 'LastName': 'Daughters', 'Affiliation': 'Department of Psychology & Neuroscience, University of North Carolina, Chapel Hill, NC, 27516, USA. Electronic address: daughter@unc.edu.'}, {'ForeName': 'Jennifer Y', 'Initials': 'JY', 'LastName': 'Yi', 'Affiliation': 'Department of Psychology & Neuroscience, University of North Carolina, Chapel Hill, NC, 27516, USA.'}, {'ForeName': 'Rachel D', 'Initials': 'RD', 'LastName': 'Phillips', 'Affiliation': 'Department of Psychology & Neuroscience, University of North Carolina, Chapel Hill, NC, 27516, USA.'}, {'ForeName': 'Regina M', 'Initials': 'RM', 'LastName': 'Carelli', 'Affiliation': 'Department of Psychology & Neuroscience, University of North Carolina, Chapel Hill, NC, 27516, USA.'}, {'ForeName': 'Flavio', 'Initials': 'F', 'LastName': 'Fröhlich', 'Affiliation': 'Carolina Center for Neurostimulation, University of North Carolina at Chapel Hill, Chapel Hill, NC 27599, USA; Department of Psychiatry, University of North Carolina at Chapel Hill, Chapel Hill, NC 27599, USA; Department of Neurology, University of North Carolina at Chapel Hill, Chapel Hill, NC 27599, USA; Department of Biomedical Engineering, University of North Carolina at Chapel Hill, Chapel Hill, NC 27599, USA; Department of Cell Biology and Physiology, University of North Carolina at Chapel Hill, Chapel Hill, NC 27599, USA; Neuroscience Center, University of North Carolina at Chapel Hill, Chapel Hill, NC 27599, USA.'}]",Drug and alcohol dependence,['10.1016/j.drugalcdep.2020.108132'] 2057,32593173,Pharmacodynamic studies of nasal tetracosactide with salivary glucocorticoids for a noninvasive Short Synacthen Test.,"CONTEXT The Short Synacthen Test (SST) is the gold standard for diagnosing adrenal insufficiency. It requires invasive administration of Synacthen, venous sampling, and is resource-intensive. OBJECTIVE To develop a nasally administered SST, with salivary glucocorticoids measurement, to assess the adrenal response. DESIGN We conducted 5 studies: 4 open-label, sequence-randomized, crossover, pharmacodynamic studies testing 6 doses/formulations and a repeatability study. Additionally, pharmacokinetic analysis was undertaken using our chosen formulation, 500 µg tetracosactide with mucoadhesive chitosan, Nasacthin003, in our pediatric study. SETTING Adult and children's clinical research facilities. PARTICIPANTS A total of 36 healthy adult males and 24 healthy children. INTERVENTION We administered all 6 nasal formulations using an European regulator endorsed atomization device. The IV comparators were 250 µg or 1 µg SST. MAIN OUTCOME MEASURES We analyzed paired blood and saliva samples for plasma cortisol and salivary cortisol and cortisone. RESULTS The addition of chitosan to tetracosactide and dose escalation increased peak cortisol response (P = 0.01 and 0.001, respectively). The bioavailability of Nasacthin003 was 14.3%. There was no significant difference in plasma cortisol at 60 minutes between 500 µg Nasacthin003 and 250 µg IV Synacthen (P = 0.17). The repeatability coefficient at 60 minutes was 105 nmol/L for IV Synacthen and salivary cortisol and cortisone was 10.3 and 21.1 nmol/L, respectively. The glucocorticoid response in children was indistinguishable from that of adults. CONCLUSIONS Nasal administration of Nasacthin003 generates equivalent plasma cortisol values to the 250-µg IV SST and, with measurement at 60 minutes of salivary cortisol or cortisone, provides a noninvasive test for adrenal insufficiency.",2020,"The addition of chitosan to tetracosactide and dose escalation increased peak cortisol response (P = 0.01 and 0.001, respectively).","[""Adult and children's clinical research facilities"", 'A total of 36 healthy adult males and 24 healthy children']",['salivary glucocorticoids'],"['plasma cortisol and salivary cortisol and cortisone', 'bioavailability of Nasacthin003', 'plasma cortisol values', 'peak cortisol response', 'repeatability coefficient', 'plasma cortisol', 'glucocorticoid response']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0686744', 'cui_str': 'Well child'}]","[{'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0017710', 'cui_str': 'Glucocorticoid'}]","[{'cui': 'C1281899', 'cui_str': 'Plasma cortisol measurement'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0010137', 'cui_str': 'Cortisone'}, {'cui': 'C0005508', 'cui_str': 'Availability, Biological'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0017710', 'cui_str': 'Glucocorticoid'}]",36.0,0.0457079,"The addition of chitosan to tetracosactide and dose escalation increased peak cortisol response (P = 0.01 and 0.001, respectively).","[{'ForeName': 'Charlotte J', 'Initials': 'CJ', 'LastName': 'Elder', 'Affiliation': 'Department of Oncology and Metabolism, The University of Sheffield, Sheffield, United Kingdom.'}, {'ForeName': 'Ruben', 'Initials': 'R', 'LastName': 'Vilela', 'Affiliation': 'Department of Oncology and Metabolism, The University of Sheffield, Sheffield, United Kingdom.'}, {'ForeName': 'Trevor N', 'Initials': 'TN', 'LastName': 'Johnson', 'Affiliation': 'Certara UK Limited, Sheffield, United Kingdom.'}, {'ForeName': 'Rosie N', 'Initials': 'RN', 'LastName': 'Taylor', 'Affiliation': 'Statistical Services Unit, The University of Sheffield, Sheffield, United Kingdom.'}, {'ForeName': 'E Helen', 'Initials': 'EH', 'LastName': 'Kemp', 'Affiliation': 'Department of Oncology and Metabolism, The University of Sheffield, Sheffield, United Kingdom.'}, {'ForeName': 'Brian G', 'Initials': 'BG', 'LastName': 'Keevil', 'Affiliation': 'Department of Clinical Biology, Manchester University NHS Trust, Manchester, United Kingdom.'}, {'ForeName': 'Alexandra S', 'Initials': 'AS', 'LastName': 'Cross', 'Affiliation': 'Department of Oncology and Metabolism, The University of Sheffield, Sheffield, United Kingdom.'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Ross', 'Affiliation': 'Department of Oncology and Metabolism, The University of Sheffield, Sheffield, United Kingdom.'}, {'ForeName': 'Neil P', 'Initials': 'NP', 'LastName': 'Wright', 'Affiliation': ""Department of Endocrinology, Sheffield Children's NHS Foundation Trust, Sheffield, United Kingdom.""}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgaa323'] 2058,32596815,"Effects of activity groups, in which art activities are used, on resilience and related factors in families with disabled children.","PURPOSE This study aims to examine the effects of activity groups using art activities on resilience and related factors in mothers with disabled children. DESIGN AND METHODS This randomized controlled experimental design study was conducted with 33 mothers (18 in the control and 15 in the intervention group). FINDINGS A statistically significant difference was found between the intervention group's pretest and posttest mean scores on the Resilience Scale for Adults, the Satisfaction with Life Scale, Zarit Burden Interview, and 12-item General Health Questionnaire scales. IMPLICATIONS FOR NURSING PRACTICE The psychological activity groups that used art activities were found to increase psychological well-being and satisfaction with life among the families of disabled children with various types of distress (physical, psychological, economic, and social), as well as reducing their mothers' perceived caregiving burden.",2020,"FINDINGS A statistically significant difference was found between the intervention group's pretest and posttest mean scores on the Resilience Scale for Adults, the Satisfaction with Life Scale, Zarit Burden Interview, and 12-item General Health Questionnaire scales. ","['33 mothers (18 in the control and 15 in the intervention group', 'families with disabled children', 'mothers with disabled children']",[],"['Resilience Scale for Adults, the Satisfaction with Life Scale, Zarit Burden Interview, and 12-item General Health Questionnaire scales', 'psychological well-being and satisfaction with life']","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0259916', 'cui_str': 'Child, Disabled'}]",[],"[{'cui': 'C0683253', 'cui_str': 'Psychological resilience'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0582668', 'cui_str': 'Satisfaction with life scale'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C4274135', 'cui_str': '12 item General Health Questionnaire'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0376558', 'cui_str': 'Life'}]",,0.0253203,"FINDINGS A statistically significant difference was found between the intervention group's pretest and posttest mean scores on the Resilience Scale for Adults, the Satisfaction with Life Scale, Zarit Burden Interview, and 12-item General Health Questionnaire scales. ","[{'ForeName': 'Gümrah Duygu', 'Initials': 'GD', 'LastName': 'Çulhacik', 'Affiliation': 'Department of Psychiatric Nursing, Faculity of Health Science, Sakarya University, Sakarya, Turkey.'}, {'ForeName': 'Gülgün', 'Initials': 'G', 'LastName': 'Durat', 'Affiliation': 'Department of Psychiatric Nursing, Faculity of Health Science, Sakarya University, Sakarya, Turkey.'}, {'ForeName': 'Nurhan', 'Initials': 'N', 'LastName': 'Eren', 'Affiliation': 'Department of Mental Health and Diseases, Internal Medical Sciences, Faculity of Medicine, Istanbul University, Istanbul, Turkey.'}]",Perspectives in psychiatric care,['10.1111/ppc.12569'] 2059,32596882,Cognitive behavioural therapy for insomnia does not appear to have a substantial impact on early markers of cardiovascular disease: A preliminary randomized controlled trial.,"According to the World Health Organization, cardiovascular diseases are the leading cause of death in the world. Therefore, early prevention of these diseases is a public health priority. Epidemiological data suggest that insomnia may be a modifiable risk factor for cardiovascular diseases. A randomized controlled trial in a sample of insomnia patients without cardiovascular disease was conducted to investigate the effects of insomnia treatment on early markers of cardiovascular diseases assessed by 24-hr ambulatory blood pressure, heart rate and heart rate variability monitoring, and morning fasting blood samples. Forty-six patients with insomnia disorder were randomized to cognitive behavioural therapy for insomnia (CBT-I; n = 23) or a waitlist control condition (n = 23). Contrary to the hypothesis, intention-to-treat analyses did not show any significant treatment effects on early markers of cardiovascular disease (d = 0.0-0.6) despite successful insomnia treatment (d = 1.3). Potential methodological and conceptual reasons for these negative findings are discussed. Future studies might include larger sample sizes that are at risk of cardiovascular diseases and focus on other cardiovascular markers.",2020,"Contrary to the hypothesis, intention-to-treat analyses did not show any significant treatment effects on early markers of cardiovascular disease (d = 0.0-0.6) despite successful insomnia treatment (d = 1.3).","['Forty-six patients with insomnia disorder', 'insomnia patients without cardiovascular disease']","['Cognitive behavioural therapy', 'cognitive behavioural therapy for insomnia (CBT-I; n\xa0=\xa023) or a waitlist control condition']","['early markers of cardiovascular disease', '24-hr ambulatory blood pressure, heart rate and heart rate variability monitoring, and morning fasting blood samples']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0855316', 'cui_str': 'Blood pressure ambulatory'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0332170', 'cui_str': 'Morning'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}]",46.0,0.0606613,"Contrary to the hypothesis, intention-to-treat analyses did not show any significant treatment effects on early markers of cardiovascular disease (d = 0.0-0.6) despite successful insomnia treatment (d = 1.3).","[{'ForeName': 'Anna Friederike', 'Initials': 'AF', 'LastName': 'Johann', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Faculty of Medicine, Medical Center - University of Freiburg, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Hertenstein', 'Affiliation': 'University Hospital of Psychiatry and Psychotherapy, Bern, Switzerland.'}, {'ForeName': 'Bernd', 'Initials': 'B', 'LastName': 'Feige', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Faculty of Medicine, Medical Center - University of Freiburg, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Umair', 'Initials': 'U', 'LastName': 'Akram', 'Affiliation': 'Department of Psychology, Sociology and Politics, Sheffield Hallam University, Sheffield, UK.'}, {'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Holub', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Faculty of Medicine, Medical Center - University of Freiburg, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Baglioni', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Faculty of Medicine, Medical Center - University of Freiburg, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Domschke', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Faculty of Medicine, Medical Center - University of Freiburg, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Schramm', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Faculty of Medicine, Medical Center - University of Freiburg, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Nissen', 'Affiliation': 'University Hospital of Psychiatry and Psychotherapy, Bern, Switzerland.'}, {'ForeName': 'Simon D', 'Initials': 'SD', 'LastName': 'Kyle', 'Affiliation': 'Nuffield Department of Clinical Neurosciences, Sleep and Circadian Neuroscience Institute (SCNi), University of Oxford, Oxford, UK.'}, {'ForeName': 'Dieter', 'Initials': 'D', 'LastName': 'Riemann', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Faculty of Medicine, Medical Center - University of Freiburg, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Biermann', 'Affiliation': 'Department of Cardiology and Angiology, Cardiac Electrophysiology, St. Franziskus-Hospital Münster, Münster, Germany.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Spiegelhalder', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Faculty of Medicine, Medical Center - University of Freiburg, University of Freiburg, Freiburg, Germany.'}]",Journal of sleep research,['10.1111/jsr.13102'] 2060,32596937,Securement to prevent device-related pressure injuries in the intensive care unit: A randomised controlled feasibility study.,"Medical device-related pressure injuries are the most common cause of pressure injuries within the intensive care unit, in particular those caused by nasogastric tubes and endotracheal tubes. There are several known methods, which can alleviate the pressure of these devices on the skin surface to reduce the rate of these injuries. To determine the feasibility of conducting a larger, adequately powered trial testing, several clinically effective interventions to reduce the incidence of medical device-related pressure injuries caused by these devices. Patients were recruited into both study arms and received one of three different methods of skin protection for both arms. Outcome measures included fidelity to the processes of care protocol, recruitment potential, and the number of medical device-related pressure injuries. Recruitment (n = 87) was slower than expected with less than 10% of screened potential patients available for enrolment. Fidelity to the process of care for each subgroup was variable with better adherence in the nasogastric tube arm compared to the endotracheal tube arm. This feasibility study has revealed concerns about the intervention designs and effectiveness as well as challenges for the adherence of the nursing staff to the protocol.",2020,Fidelity to the process of care for each subgroup was variable with better adherence in the nasogastric tube arm compared to the endotracheal tube arm.,['intensive care unit'],[],"['fidelity to the processes of care protocol, recruitment potential, and the number of medical device-related pressure injuries']","[{'cui': 'C0021708', 'cui_str': 'Intensive care unit'}]",[],"[{'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0250336', 'cui_str': 'CARE protocol'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0332679', 'cui_str': 'Crushing injury'}]",87.0,0.0382754,Fidelity to the process of care for each subgroup was variable with better adherence in the nasogastric tube arm compared to the endotracheal tube arm.,"[{'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Coyer', 'Affiliation': ""Joint appointment Intensive Care Services, Royal Brisbane and Women's Hospital and School of Nursing, Queensland University of Technology, Australia.""}, {'ForeName': 'Jane-Louise', 'Initials': 'JL', 'LastName': 'Cook', 'Affiliation': 'School of Nursing, Queensland University of Technology, Brisbane, Australia.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Brown', 'Affiliation': 'Department of Intensive Care, Redcliffe Hospital, Redcliffe, Australia.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Vann', 'Affiliation': ""Intensive Care Services, Royal Brisbane and Women's Hospital, Brisbane, Australia.""}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Doubrovsky', 'Affiliation': 'School of Nursing, Queensland University of Technology, Brisbane, Australia.'}]",International wound journal,['10.1111/iwj.13432'] 2061,32596938,Re: Incidence and characteristics of pregnancy-related death across ten low- and middle-income geographical regions: secondary analysis of a cluster randomised controlled trial: The underestimated scourge of eclampsia in low-income countries.,,2020,,[],[],[],[],[],[],,0.361711,,"[{'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Scioscia', 'Affiliation': 'Department of Obstetrics and Gynaecology, Policlinico Hospital, Abano Terme, Padua, Italy.'}, {'ForeName': 'Edgardo', 'Initials': 'E', 'LastName': 'Somigliana', 'Affiliation': ""Università degli Studi di Milano and Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.""}, {'ForeName': 'Sartie', 'Initials': 'S', 'LastName': 'Kenneh', 'Affiliation': 'Ministry of Health and Sanitation, Government of Sierra Leone, Freetown, Sierra Leone.'}, {'ForeName': 'Pierre-Yves', 'Initials': 'PY', 'LastName': 'Robillard', 'Affiliation': ""Service de Néonatologie-Centre d'Etudes Périnatales Océan Indien (CEPOI), Centre Hospitalier Universitaire Sud Réunion, Saint-Pierre Cedex, La Réunion.""}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Dalle Carbonare', 'Affiliation': 'Department of Obstetrics and Gynaecology, Policlinico Hospital, Abano Terme, Padua, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Putoto', 'Affiliation': 'Operational Research Unit, Doctors with Africa CUAMM, Padua, Italy.'}]",BJOG : an international journal of obstetrics and gynaecology,['10.1111/1471-0528.16351'] 2062,32597013,Continued capacity: Factors of importance for organizations to support continued Let's Talk practice - a mixed-methods study.,"Sustainability is a desired outcome of implementation. Understanding how organizations support new practices after implementation is important for sustainability. Let's Talk about Children (hereby referred to as 'Let's Talk'), a family-focused intervention with parents with a mental illness, improves family, parent, and child outcomes. Little is understood about how organizations support sustained practice. The study aimed to (i) understand the implementation process that occurred in eight adult mental health services during a previous randomized controlled trial; (ii) establish their continued capacity to embed Let's Talk; and (iii) explore links between organizational capacity and sustained delivery by practitioners. This mixed method study used a questionnaire and individual interviews to collect data on the implementation process and current organizational capacity to support Let's Talk 12months after the randomized controlled trial. Links between organizational capacity and the adult mental health services with practitioners' continuing to use Let's Talk in the past 12 months were explored. Services with higher current organizational capacity scores had practitioners currently delivering Let's Talk. These services had all made changes to their organizational structures to support Let's Talk practice. All services experienced significant changes during and after implementation, influencing sustainability of Let's Talk. Addressing organizational capacity appears to be important to enable sustainability of Let's Talk implementation endeavours. Real-world settings are constantly changing systems requiring ongoing tracking and adjustments to understand and support sustainability. Internal service development staff appear to support the shaping of organizational capacity to support Let's Talk; however, broader organizational support is needed for change within a complex system.",2020,Links between organizational capacity and the adult mental health services with practitioners' continuing to use Let's Talk in the past 12 months were explored.,['eight adult mental health services'],[],"[""sustainability of Let's Talk""]","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0025355', 'cui_str': 'Mental health service'}]",[],"[{'cui': 'C0086562', 'cui_str': 'Energy Transfer, Linear'}, {'cui': 'C0037817', 'cui_str': 'Speech'}]",,0.0268096,Links between organizational capacity and the adult mental health services with practitioners' continuing to use Let's Talk in the past 12 months were explored.,"[{'ForeName': 'Becca', 'Initials': 'B', 'LastName': 'Allchin', 'Affiliation': 'School of Rural Health, Faculty of Medicine, Nursing and Health Sciences, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Bente M', 'Initials': 'BM', 'LastName': 'Weimand', 'Affiliation': 'Department of Nursing and Health Promotion, Faculty of Health Sciences, OsloMet - Oslo Metropolitan University, Oslo, Norway.'}, {'ForeName': 'Brendan', 'Initials': 'B', 'LastName': ""O'Hanlon"", 'Affiliation': 'The Bouverie Centre, La Trobe University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Melinda', 'Initials': 'M', 'LastName': 'Goodyear', 'Affiliation': 'School of Rural Health, Faculty of Medicine, Nursing and Health Sciences, Monash University, Melbourne, Victoria, Australia.'}]",International journal of mental health nursing,['10.1111/inm.12754'] 2063,32597030,Effect of low energy availability during three consecutive days of endurance training on iron metabolism in male long distance runners.,"We investigated the effect of low energy availability (LEA) during three consecutive days of endurance training on muscle glycogen content and iron metabolism. Six male long distance runners completed three consecutive days of endurance training under LEA or neutral energy availability (NEA) conditions. Energy availability was set at 20 kcal/kg fat-free mass (FFM)/day for LEA and 45 kcal/kg FFM/day for NEA. The subjects ran for 75 min at 70% of maximal oxygen uptake ( V ˙ O 2max ) on days 1-3. Venous blood samples were collected following an overnight fast on days 1-4, immediately and 3 hr after exercise on day 3. The muscle glycogen content on days 1-4 was evaluated by carbon-magnetic resonance spectroscopy. In LEA condition, the body weight and muscle glycogen content on days 2-4, and the FFM on days 2 and 4 were significantly lower than those on day1 (p < .05 vs. day1), whereas no significant change was observed throughout the training period in NEA condition. On day 3, muscle glycogen content before exercise was negatively correlated with serum iron level (immediately after exercise, 3 hr after exercise), serum hepcidin level immediately after exercise, and plasma IL-6 level immediately after exercise (p < .05). Moreover, serum hepcidin level on day 4 was significantly higher in LEA condition than that in NEA condition (p < .05). In conclusion, three consecutive days of endurance training under LEA reduced the muscle glycogen content with concomitant increased serum hepcidin levels in male long distance runners.",2020,"Moreover, serum hepcidin level on day 4 was significantly higher in LEA condition than that in NEA condition (p < .05).","['male long distance runners', 'Six male long distance runners']","['endurance training under LEA or neutral energy availability (NEA) conditions', 'endurance training', 'low energy availability (LEA']","['serum iron level', 'serum hepcidin level immediately after exercise, and plasma IL-6 level', 'muscle glycogen content and iron metabolism', 'Venous blood samples', 'iron metabolism', 'serum hepcidin levels', 'Energy availability', 'body weight and muscle glycogen content', 'serum hepcidin level']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0012751', 'cui_str': 'Distance'}]","[{'cui': 'C4704697', 'cui_str': 'Endurance Training'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C1318312', 'cui_str': 'Serum iron measurement'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0966897', 'cui_str': 'Hepcidin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205548', 'cui_str': 'Stat'}, {'cui': 'C1979962', 'cui_str': 'After exercise'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0017911', 'cui_str': 'Glycogen'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0444255', 'cui_str': 'Venous blood specimen'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}]",6.0,0.0243692,"Moreover, serum hepcidin level on day 4 was significantly higher in LEA condition than that in NEA condition (p < .05).","[{'ForeName': 'Aya', 'Initials': 'A', 'LastName': 'Ishibashi', 'Affiliation': 'Japan Institute of Sports Sciences, Kitaku, Tokyo, Japan.'}, {'ForeName': 'Chihiro', 'Initials': 'C', 'LastName': 'Kojima', 'Affiliation': 'Japan Institute of Sports Sciences, Kitaku, Tokyo, Japan.'}, {'ForeName': 'Yoko', 'Initials': 'Y', 'LastName': 'Tanabe', 'Affiliation': 'Faculty of Health and Sport Sciences, University of Tsukuba, Tsukuba, Ibaraki, Japan.'}, {'ForeName': 'Kaito', 'Initials': 'K', 'LastName': 'Iwayama', 'Affiliation': 'Department of Budo and Sport Studies, Tenri University, Tenri, Nara, Japan.'}, {'ForeName': 'Tsutomu', 'Initials': 'T', 'LastName': 'Hiroyama', 'Affiliation': 'Faculty of Health and Sport Sciences, University of Tsukuba, Tsukuba, Ibaraki, Japan.'}, {'ForeName': 'Toshiki', 'Initials': 'T', 'LastName': 'Tsuji', 'Affiliation': 'Faculty of Health and Sport Sciences, University of Tsukuba, Tsukuba, Ibaraki, Japan.'}, {'ForeName': 'Akiko', 'Initials': 'A', 'LastName': 'Kamei', 'Affiliation': 'Japan Institute of Sports Sciences, Kitaku, Tokyo, Japan.'}, {'ForeName': 'Kazushige', 'Initials': 'K', 'LastName': 'Goto', 'Affiliation': 'Graduate School of Sport and Health Science, Ritsumeikan University, Kusatsu, Shiga, Japan.'}, {'ForeName': 'Hideyuki', 'Initials': 'H', 'LastName': 'Takahashi', 'Affiliation': 'Japan Institute of Sports Sciences, Kitaku, Tokyo, Japan.'}]",Physiological reports,['10.14814/phy2.14494'] 2064,32597035,Effect of milk fat globule membrane supplementation on motor unit adaptation following resistance training in older adults.,"This study aimed to investigate the effect of milk fat globule membrane (MFGM) supplementation on motor unit adaptation following resistance training in older adults. Twenty-five older males and females took MFGM (n = 12) or a placebo (PLA; n = 12) while performing 8 weeks of isometric knee extension training. During the training, the motor unit firing pattern during submaximal contractions, muscle thickness, and maximal muscle strength of knee extensor muscles were measured every 2 weeks. None of the measurements showed significant differences in muscle thickness or maximal muscle strength (MVC) between the two groups (p > .05). Significant decreases in motor unit firing rate following the intervention were observed in PLA, that is, 14.1 ± 2.7 pps at 0 weeks to 13.0 ± 2.4 pps at 4 weeks (p = .003), but not in MFGM (14.4 ± 2.5 pps to 13.8 ± 1.9 pps). Motor unit firing rates in MFGM were significantly higher than those in PLA at 2, 4, 6, and 8 weeks of the intervention, that is, 15.1 ± 2.3 pps in MFGM and 14.5 ± 3.3 pps in PLA at 70% of MVC for motor units recruited at 40% of MVC at 6 weeks (p = .034). Significant differences in firing rates among motor units with different recruitment thresholds were newly observed following the resistance training intervention in MFGM, indicating that motor unit firing pattern is changed in this group. These results suggest that motor unit adaptation following resistance training is modulated by MFGM supplementation in older adults.",2020,"Significant differences in firing rates among motor units with different recruitment thresholds were newly observed following the resistance training intervention in MFGM, indicating that motor unit firing pattern is changed in this group.","['Twenty-five older males and females took MFGM (n\xa0=\xa012) or a', 'older adults']","['milk fat globule membrane supplementation', 'milk fat globule membrane (MFGM) supplementation', 'MFGM supplementation', 'placebo (PLA; n\xa0=\xa012) while performing 8\xa0weeks of isometric knee extension training']","['motor unit firing rate', 'Motor unit firing rates in MFGM', 'firing rates', 'motor unit firing pattern during submaximal contractions, muscle thickness, and maximal muscle strength of knee extensor muscles', 'muscle thickness or maximal muscle strength (MVC', 'motor unit adaptation']","[{'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0670751', 'cui_str': 'milk fat globule'}, {'cui': 'C0025255', 'cui_str': 'Membrane Tissue'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0670751', 'cui_str': 'milk fat globule'}, {'cui': 'C0025255', 'cui_str': 'Membrane Tissue'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0014007', 'cui_str': 'Dismissed from job'}, {'cui': 'C0670751', 'cui_str': 'milk fat globule'}, {'cui': 'C0025255', 'cui_str': 'Membrane Tissue'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0000934', 'cui_str': 'Acclimation'}]",25.0,0.0321513,"Significant differences in firing rates among motor units with different recruitment thresholds were newly observed following the resistance training intervention in MFGM, indicating that motor unit firing pattern is changed in this group.","[{'ForeName': 'Kohei', 'Initials': 'K', 'LastName': 'Watanabe', 'Affiliation': 'Laboratory of Neuromuscular Biomechanics, School of International Liberal Studies, Chukyo University, Nagoya, Japan.'}, {'ForeName': 'Aleš', 'Initials': 'A', 'LastName': 'Holobar', 'Affiliation': 'Faculty of Electrical Engineering and Computer Science, University of Maribor, Maribor, Slovenia.'}, {'ForeName': 'Aya', 'Initials': 'A', 'LastName': 'Tomita', 'Affiliation': 'Laboratory of Neuromuscular Biomechanics, School of International Liberal Studies, Chukyo University, Nagoya, Japan.'}, {'ForeName': 'Yukiko', 'Initials': 'Y', 'LastName': 'Mita', 'Affiliation': 'Department of Human Nutrition, School of Life Studies, Sugiyama Jogakuen University, Nagoya, Japan.'}]",Physiological reports,['10.14814/phy2.14491'] 2065,32484261,Long-term effects of high-intensity training vs moderate intensity training in heart transplant recipients: A 3-year follow-up study of the randomized-controlled HITTS study.,"The randomized controlled High-Intensity Interval Training in De Novo Heart Transplant Recipients in Scandinavia (HITTS) study compared 9 months of high-intensity interval training (HIT) with moderate intensity continuous training in de novo heart transplant recipients. In our 3-year follow-up study, we aimed to determine whether the effect of early initiation of HIT on peak oxygen consumption (VO 2peak ) persisted for 2 years postintervention. The study's primary end point was the change in VO 2peak (mL/kg/min). The secondary end points were muscle strength, body composition, heart rate response, health-related quality of life, daily physical activity, biomarkers, and heart function. Of 78 patients who completed the 1-year HITTS trial, 65 entered our study and 62 completed the study tests. VO 2peak increased from baseline to 1 year and leveled off thereafter. During the intervention period, the increase in VO 2peak was larger in the HIT arm; however, 2 years later, there was no significant between-group difference in VO 2peak . However, the mean change in the anaerobic threshold and extensor muscle endurance remained significantly higher in the HIT group. Early initiation of HIT after heart transplantation appears to have some sustainable long-term effects. Clinical trial registration number: NCT01796379.",2020,"During the intervention period, the increase in VO 2peak was larger in the HIT arm; however, 2 years later, there was no significant between-group difference in VO 2peak .","['De Novo Heart Transplant Recipients in Scandinavia (HITTS', 'heart transplant recipients', '78 patients who completed the 1-year HITTS trial, 65 entered our study and 62 completed the study tests', 'in de novo heart transplant recipients']","['Intensity Interval Training', 'high-intensity interval training (HIT) with moderate intensity continuous training', 'high-intensity training vs. moderate intensity training']","['VO 2peak', 'change in VO 2peak (mL/kg/min', 'peak oxygen consumption (VO 2peak ', 'muscle strength, body composition, heart rate response, health-related quality of life, daily physical activity, biomarkers and heart function', 'anaerobic threshold and extensor muscle endurance']","[{'cui': 'C2029943', 'cui_str': 'Transplanted heart present'}, {'cui': 'C0036273', 'cui_str': 'Nordic Countries'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1522196', 'cui_str': 'Enteral route'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]","[{'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0439402', 'cui_str': 'mL/min/kg'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C1997754', 'cui_str': 'Heart rate response'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0232164', 'cui_str': 'Cardiac function'}, {'cui': 'C0002749', 'cui_str': 'Anaerobic Threshold'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}]",78.0,0.0659216,"During the intervention period, the increase in VO 2peak was larger in the HIT arm; however, 2 years later, there was no significant between-group difference in VO 2peak .","[{'ForeName': 'Katrine', 'Initials': 'K', 'LastName': 'Rolid', 'Affiliation': 'Department of Cardiology, Oslo University Hospital Rikshospitalet, Oslo, Norway.'}, {'ForeName': 'Arne K', 'Initials': 'AK', 'LastName': 'Andreassen', 'Affiliation': 'Department of Cardiology, Oslo University Hospital Rikshospitalet, Oslo, Norway.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Yardley', 'Affiliation': 'Department of Cardiology, Oslo University Hospital Rikshospitalet, Oslo, Norway.'}, {'ForeName': 'Einar', 'Initials': 'E', 'LastName': 'Gude', 'Affiliation': 'Department of Cardiology, Oslo University Hospital Rikshospitalet, Oslo, Norway.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Bjørkelund', 'Affiliation': 'Department of Cardiology, Oslo University Hospital Rikshospitalet, Oslo, Norway.'}, {'ForeName': 'Anne R', 'Initials': 'AR', 'LastName': 'Authen', 'Affiliation': 'Department of Cardiology, Oslo University Hospital Rikshospitalet, Oslo, Norway.'}, {'ForeName': 'Ingelin', 'Initials': 'I', 'LastName': 'Grov', 'Affiliation': 'Department of Cardiology, Oslo University Hospital Rikshospitalet, Oslo, Norway.'}, {'ForeName': 'Kaspar', 'Initials': 'K', 'LastName': 'Broch', 'Affiliation': 'Department of Cardiology, Oslo University Hospital Rikshospitalet, Oslo, Norway.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Gullestad', 'Affiliation': 'Department of Cardiology, Oslo University Hospital Rikshospitalet, Oslo, Norway.'}, {'ForeName': 'Kari', 'Initials': 'K', 'LastName': 'Nytrøen', 'Affiliation': 'Department of Cardiology, Oslo University Hospital Rikshospitalet, Oslo, Norway.'}]",American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons,['10.1111/ajt.16087'] 2066,32480076,Microstructural white matter changes following gait training with Hybrid Assistive Limb initiated within 1 week of stroke onset.,"The early initiation of robot-assisted gait training in patients with acute stroke could promote neuroplasticity. The aim of this study was to clarify the microstructural changes of white matter associated with gait training using Hybrid Assistive Limb (HAL) by diffusion tensor imaging (DTI). Patients with first-ever stroke and requiring a walking aid started gait training within 1 week of stroke onset. The patients were quasi-randomly assigned either to the conventional physical therapy (CPT) group or gait training using HAL (HAL) group. Motor function and DTI were examined at baseline and after 3-5 months. Voxel-based statistical analyses of fractional anisotropy (FA) images were performed using diffusion metric voxel-wise analyses. Volume of interest (VOI)-based analyses were used to assess changes in FA (ΔFA). Twenty-seven patients (17 in the CPT group and 10 in the HAL group) completed the study. There were improvements in motor function and independency in the CPT and HAL groups (p < .001). Compared to baseline, there were decreases in FA in the ipsi-lesional cerebral peduncle in the CPT group (p < .001) and increases in the contra-lesional rostrum of the corpus callosum in the HAL group (p < .001) at the second assessment, consistent with the mean ΔFA in each group from VOI analysis (CPT/HAL: cerebral peduncle, -0.066/-0.027, p = .027; corpus callosum, 0.002/0.042, p < .001). Gait training using HAL initiated within 1 week after stroke onset facilitated the recovery of inter-hemispheric communication and prevented the progression of Wallerian degeneration of the affected pyramidal tract.",2020,"Compared to baseline, there were decreases in FA in the ipsi-lesional cerebral peduncle in the CPT group (p < .001) and increases in the contra-lesional rostrum of the corpus callosum in the HAL group (p < .001) at the second assessment, consistent with the mean ΔFA in each group from VOI analysis (CPT/HAL: cerebral peduncle, -0.066/-0.027, p = .027; corpus callosum, 0.002/0.042, p < .001).","['Twenty-seven patients (17 in the CPT group and 10 in the HAL group) completed the study', 'Patients with first-ever stroke and requiring a walking aid started gait training within 1\xa0week of stroke onset', 'patients with acute stroke']","['Gait training using HAL', 'gait training using Hybrid Assistive Limb (HAL) by diffusion tensor imaging (DTI', 'robot-assisted gait training', 'conventional physical therapy (CPT) group or gait training using HAL (HAL', 'gait training with Hybrid Assistive Limb']","['Motor function and DTI', 'changes in FA (ΔFA', 'contra-lesional rostrum of the corpus callosum', 'motor function and independency', 'FA in the ipsi-lesional cerebral peduncle']","[{'cui': 'C4319602', 'cui_str': '27'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0007597', 'cui_str': 'Cell hybridization'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0021588', 'cui_str': 'Artificial insemination, heterologous'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0085673', 'cui_str': 'Gait training procedure'}, {'cui': 'C1442452', 'cui_str': 'One week'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0751956', 'cui_str': 'Acute stroke'}]","[{'cui': 'C0085673', 'cui_str': 'Gait training procedure'}, {'cui': 'C0007597', 'cui_str': 'Cell hybridization'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C1537007', 'cui_str': 'Diffusion Tensor MRI'}, {'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0234130', 'cui_str': 'Motor function'}, {'cui': 'C1537007', 'cui_str': 'Diffusion Tensor MRI'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0085406', 'cui_str': 'Anisotropy'}, {'cui': 'C0152322', 'cui_str': 'Structure of rostrum of corpus callosum'}, {'cui': 'C0007793', 'cui_str': 'Cerebral peduncle structure'}]",27.0,0.0293157,"Compared to baseline, there were decreases in FA in the ipsi-lesional cerebral peduncle in the CPT group (p < .001) and increases in the contra-lesional rostrum of the corpus callosum in the HAL group (p < .001) at the second assessment, consistent with the mean ΔFA in each group from VOI analysis (CPT/HAL: cerebral peduncle, -0.066/-0.027, p = .027; corpus callosum, 0.002/0.042, p < .001).","[{'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Ando', 'Affiliation': 'Department of Cerebrovascular Medicine, National Cerebral and Cardiovascular Center, Suita, Japan.'}, {'ForeName': 'Chiaki', 'Initials': 'C', 'LastName': 'Yokota', 'Affiliation': 'Department of Cerebrovascular Medicine, National Cerebral and Cardiovascular Center, Suita, Japan; Department of Stroke Rehabilitation, National Cerebral and Cardiovascular Center, Suita, Japan. Electronic address: cyokota@ncvc.go.jp.'}, {'ForeName': 'Kazuhiro', 'Initials': 'K', 'LastName': 'Koshino', 'Affiliation': 'Department of Systems and Informatics, Hokkaido Information University, Ebetsu, Japan. Electronic address: koshino@do-johodai.ac.jp.'}, {'ForeName': 'Fumihiko', 'Initials': 'F', 'LastName': 'Yasuno', 'Affiliation': 'Department of Psychiatry, National Center for Geriatrics and Gerontology, Obu, Aichi, Japan. Electronic address: yasunof@ncgg.go.jp.'}, {'ForeName': 'Takeo', 'Initials': 'T', 'LastName': 'Sato', 'Affiliation': 'Department of Cerebrovascular Medicine, National Cerebral and Cardiovascular Center, Suita, Japan.'}, {'ForeName': 'Akihide', 'Initials': 'A', 'LastName': 'Yamamoto', 'Affiliation': 'Department of Industrial-Academic Collaboration, Open Innovation Center, National Cerebral and Cardiovascular Center, Suita, Japan. Electronic address: ayamamot@ncvc.go.jp.'}, {'ForeName': 'Hirotaka', 'Initials': 'H', 'LastName': 'Odani', 'Affiliation': 'Department of Cerebrovascular Medicine, National Cerebral and Cardiovascular Center, Suita, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Nakajima', 'Affiliation': 'Department of Neurology, National Hospital Organization Niigata National Hospital, Kashiwazaki, Japan. Electronic address: nakajima.takashi.ud@mail.hosp.go.jp.'}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Higuchi', 'Affiliation': 'Department of Nuclear Medicine and Comprehensive Heart Failure Center, University of Würzburg, Würzburg, Germany.'}, {'ForeName': 'Eisuke', 'Initials': 'E', 'LastName': 'Tatsumi', 'Affiliation': 'Open Innovation Center, National Cerebral and Cardiovascular Center, Suita, Japan. Electronic address: tatsumi@ncvc.go.jp.'}]",Journal of the neurological sciences,['10.1016/j.jns.2020.116939'] 2067,32480103,Safety and placement stability for the Children's Home Network kinship navigator program.,"BACKGROUND With the passage of the Families First Prevention Act, kinship navigator programs have growing support as an intervention to connect kinship families to needed resources. Growing evidence has helped to showcase the outcomes, but no study has shared follow up outcomes past twelve months. OBJECTIVE This study examined the 12, 24 and 36 month follow up child safety (substantiated abuse record) and placement stability (disruption in placement) outcomes from state administered secondary data for children whose caregivers participated in the Children's Home Network-Kinship Navigator Program (CHN-KN). SETTING Study participants were 240 (60 in each group) randomly selected kinship caregivers who were enrolled in four treatment groups in CHN-KN (Standard Kinship Navigator, Kinship Navigator with Innovations, Kinship Navigator with Peer-to-Peer only, and Usual Child Welfare). METHODS Repeated measures anovas were used to show between group differences for each study group. RESULTS Results show that children living with caregivers who received Kinship Navigator Programs (Kinship Navigator Peer to Peer and Kinship Navigator with Innovations) were the least likely to be involved in a substantiation of child abuse or neglect and most likely to remain in the home of a relative at 12, 24 and 36 month follow up. CONCLUSIONS Results suggest that the kinship navigator programs could improve child safety and placement stability. This study can help to inform the replication of the CHN-KN model and provide additional supported evidence to inform practice.",2020,"outcomes from state administered secondary data for children whose caregivers participated in the Children's Home Network-Kinship Navigator Program (CHN-KN). ","[""Children's Home Network kinship navigator program"", 'Study participants were 240 (60 in each group) randomly selected kinship caregivers who were enrolled in four treatment groups in', ""children whose caregivers participated in the Children's Home Network-Kinship Navigator Program (CHN-KN"", 'children living with caregivers']","['CHN-KN (Standard Kinship Navigator, Kinship Navigator with Innovations, Kinship Navigator with Peer-to-Peer only, and Usual Child Welfare', 'Kinship Navigator Programs (Kinship Navigator Peer to Peer and Kinship Navigator with Innovations']","['Safety and placement stability', 'child safety (substantiated abuse record) and placement stability (disruption in placement', 'child safety and placement stability']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4319600', 'cui_str': '240'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0553288', 'cui_str': 'Lives with children'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0008093', 'cui_str': 'Child Well Being'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0562381', 'cui_str': 'Victim of abuse'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0332453', 'cui_str': 'Disruption'}]",240.0,0.0249446,"outcomes from state administered secondary data for children whose caregivers participated in the Children's Home Network-Kinship Navigator Program (CHN-KN). ","[{'ForeName': 'Kerry', 'Initials': 'K', 'LastName': 'Littlewood', 'Affiliation': 'The University of South Florida School of Social Work, Tampa, FL, United States. Electronic address: littlewood@usf.edu.'}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Cooper', 'Affiliation': ""Children's Home Network, Tampa, FL, 33620, United States. Electronic address: lcooper@childrenshomenetwork.org.""}, {'ForeName': 'Abhishek', 'Initials': 'A', 'LastName': 'Pandey', 'Affiliation': 'The University of South Florida, Tampa, FL, United States. Electronic address: apandey47@gmail.com.'}]",Child abuse & neglect,['10.1016/j.chiabu.2020.104506'] 2068,32484850,Prevention of adverse drug reactions in hospitalized older patients with multi-morbidity and polypharmacy: the SENATOR* randomized controlled clinical trial.,"BACKGROUND Multi-morbidity and polypharmacy increase the risk of non-trivial adverse drug reactions (ADRs) in older people during hospitalization. Despite this, there are no established interventions for hospital-acquired ADR prevention. METHODS We undertook a pragmatic, multi-national, parallel arm prospective randomized open-label, blinded endpoint (PROBE) controlled trial enrolling patients at six European medical centres. We randomized 1,537 older medical and surgical patients with multi-morbidity and polypharmacy on admission in a 1:1 ratio to SENATOR software-guided medication optimization plus standard care (intervention, n = 772, mean number of daily medications = 9.34) or standard care alone (control, n = 765, mean number of daily medications = 9.23) using block randomization stratified by site and admission type. Attending clinicians in the intervention arm received SENATOR-generated advice at a single time point with recommendations they could choose to adopt or not. The primary endpoint was occurrence of probable or certain ADRs within 14 days of randomization. Secondary endpoints were primary endpoint derivatives; tertiary endpoints included all-cause mortality, re-hospitalization, composite healthcare utilization and health-related quality of life. RESULTS For the primary endpoint, there was no difference between the intervention and control groups (24.5 vs. 24.8%; OR 0.98; 95% CI 0.77-1.24; P = 0.88). Similarly, with secondary and tertiary endpoints, there were no significant differences. Among attending clinicians in the intervention group, implementation of SENATOR software-generated medication advice points was poor (~15%). CONCLUSIONS In this trial, uptake of software-generated medication advice to minimize ADRs was poor and did not reduce ADR incidence during index hospitalization.",2020,"In this trial, uptake of software-generated medication advice to minimize ADRs was poor and did not reduce ADR incidence during index hospitalization.","['enrolling patients at six European medical centres', '1,537 older medical and surgical patients with multi-morbidity and polypharmacy on admission in a 1:1 ratio to SENATOR software-guided medication optimization plus standard care (intervention, n\u2009=\u2009772, mean number of daily medications\u2009=\u20099.34) or', 'hospitalized older patients with multi-morbidity and polypharmacy', 'older people during hospitalization']","['standard care alone (control, n\u2009=\u2009765, mean number of daily medications\u2009=\u20099.23) using block randomization stratified by site and admission type']","['occurrence of probable or certain ADRs', 'cause mortality, re-hospitalization, composite healthcare utilization and health-related quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C1948041', 'cui_str': 'Surgical and medical procedures'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C2922974', 'cui_str': 'Polypharmacy'}, {'cui': 'C0457453', 'cui_str': 'On admission'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0037585', 'cui_str': 'Software'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0205423', 'cui_str': 'Certain'}, {'cui': 'C0041755', 'cui_str': 'Adverse reaction to drug'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",1537.0,0.223776,"In this trial, uptake of software-generated medication advice to minimize ADRs was poor and did not reduce ADR incidence during index hospitalization.","[{'ForeName': 'Denis', 'Initials': 'D', 'LastName': ""O'Mahony"", 'Affiliation': 'University College Cork School of Medicine-Medicine Cork Ireland, Cork University Hospital Group, Cork, Ireland.'}, {'ForeName': 'Adalsteinn', 'Initials': 'A', 'LastName': 'Gudmundsson', 'Affiliation': 'Landspitali University Hospital Reykjavik, Landspitali, Iceland.'}, {'ForeName': 'Roy L', 'Initials': 'RL', 'LastName': 'Soiza', 'Affiliation': 'NHS Grampian, University of Aberdeen Institute of Applied Health Sciences-Ageing Clinical and Experimental Research, Aberdeen, UK.'}, {'ForeName': 'Mirko', 'Initials': 'M', 'LastName': 'Petrovic', 'Affiliation': 'University of Ghent-Medicine, University Hospital Ghent, Ghent, Belgium.'}, {'ForeName': 'Alfonso', 'Initials': 'A', 'LastName': 'Jose Cruz-Jentoft', 'Affiliation': 'Hospital Universario Ramón y Cajal-Geriatrics, Madrid, Spain.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Cherubini', 'Affiliation': 'Italian National Research Center on Aging (IRCCS-INRCA), Geriatrics and Geriatrics Emergency Care, Ancona, Italy.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Fordham', 'Affiliation': 'Faculty of Medicine and Health Sciences, University of East Anglia, Norwich, UK.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Byrne', 'Affiliation': 'School of Pharmacy, University College Cork, Cork, Ireland.'}, {'ForeName': 'Darren', 'Initials': 'D', 'LastName': 'Dahly', 'Affiliation': 'University College Cork, Cork, Ireland.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Gallagher', 'Affiliation': 'Cork University Hospital-Geriatric Medicine, Cork, Ireland.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Lavan', 'Affiliation': 'University College Cork, School of Medicine-Geriatrics, Cork, Ireland.'}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Curtin', 'Affiliation': 'University College Cork, School of Medicine-Geriatrics, Cork, Ireland.'}, {'ForeName': 'Kieran', 'Initials': 'K', 'LastName': 'Dalton', 'Affiliation': 'University College Cork, National University of Ireland, Pharmaceutical Care Research Group, School of Pharmacy, Cork Ireland.'}, {'ForeName': 'Shane', 'Initials': 'S', 'LastName': 'Cullinan', 'Affiliation': 'Royal College of Surgeons, School of Pharmacy, Dublin, Ireland.'}, {'ForeName': 'Evelyn', 'Initials': 'E', 'LastName': 'Flanagan', 'Affiliation': 'University College Cork, Clinical Research Facility, Cork, Ireland.'}, {'ForeName': 'Frances', 'Initials': 'F', 'LastName': 'Shiely', 'Affiliation': 'University College Cork, School of Epidemiology and Public Health, Cork, Ireland.'}, {'ForeName': 'Olafur', 'Initials': 'O', 'LastName': 'Samuelsson', 'Affiliation': 'Landspitali University Hospital, Geriatric Medicine Reykjavik, Iceland.'}, {'ForeName': 'Astros', 'Initials': 'A', 'LastName': 'Sverrisdottir', 'Affiliation': 'Landspitali University Hospital, Geriatric Medicine Reykjavik, Iceland.'}, {'ForeName': 'Selvarani', 'Initials': 'S', 'LastName': 'Subbarayan', 'Affiliation': 'NHS Grampian, Aberdeen Royal Infirmary, Aberdeen UK.'}, {'ForeName': 'Lore', 'Initials': 'L', 'LastName': 'Vandaele', 'Affiliation': 'University Hospital Ghent, Ghent, Belgium.'}, {'ForeName': 'Eline', 'Initials': 'E', 'LastName': 'Meireson', 'Affiliation': 'University Hospital Ghent, Ghent, Belgium.'}, {'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Montero-Errasquin', 'Affiliation': 'Hospital Universario Ramón y Cajal-Geriatrics, Madrid, Spain.'}, {'ForeName': 'Aurora', 'Initials': 'A', 'LastName': 'Rexach-Cano', 'Affiliation': 'Hospital Universario Ramón y Cajal-Geriatrics, Madrid, Spain.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Correa Perez', 'Affiliation': 'Hospital Universario Ramón y Cajal-Geriatrics, Madrid, Spain.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Lozano-Montoya', 'Affiliation': 'Hospital Universario Ramón y Cajal-Geriatrics, Madrid, Spain.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Vélez-Díaz-Pallarés', 'Affiliation': 'Hospital Universario Ramón y Cajal-Geriatrics, Madrid, Spain.'}, {'ForeName': 'Annarita', 'Initials': 'A', 'LastName': 'Cerenzia', 'Affiliation': 'Italian National Research Center on Aging (IRCCS-INRCA), Geriatrics and Geriatrics Emergency Care, Ancona, Italy.'}, {'ForeName': 'Samanta', 'Initials': 'S', 'LastName': 'Corradi', 'Affiliation': 'Italian National Research Center on Aging (IRCCS-INRCA), Geriatrics and Geriatrics Emergency Care, Ancona, Italy.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Soledad Cotorruelo Ferreiro', 'Affiliation': 'Italian National Research Center on Aging (IRCCS-INRCA), Geriatrics and Geriatrics Emergency Care, Ancona, Italy.'}, {'ForeName': 'Federica', 'Initials': 'F', 'LastName': 'Dimitri', 'Affiliation': 'Italian National Research Center on Aging (IRCCS-INRCA), Geriatrics and Geriatrics Emergency Care, Ancona, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Marinelli', 'Affiliation': 'Italian National Research Center on Aging (IRCCS-INRCA), Geriatrics and Geriatrics Emergency Care, Ancona, Italy.'}, {'ForeName': 'Gaia', 'Initials': 'G', 'LastName': 'Martelli', 'Affiliation': 'Italian National Research Center on Aging (IRCCS-INRCA), Geriatrics and Geriatrics Emergency Care, Ancona, Italy.'}, {'ForeName': 'Rebekah', 'Initials': 'R', 'LastName': 'Fong Soe Khioe', 'Affiliation': 'University of East Anglia, Faculty of Medicine and Health Sciences, Norwich, UK.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Eustace', 'Affiliation': 'University College Cork, National University of Ireland-Clinical Research Facility, Cork, Ireland.'}]",Age and ageing,['10.1093/ageing/afaa072'] 2069,32485743,"Letter to the Editor from Melanson et al (second letter): ""Twice as High Diet-Induced Thermogenesis After Breakfast vs Dinner on High-Calorie as Well as Low-Calorie Meals"".",,2020,,[],['High Diet-Induced Thermogenesis'],[],[],"[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0018841', 'cui_str': 'Heat Production'}]",[],,0.01543,,"[{'ForeName': 'Edward L', 'Initials': 'EL', 'LastName': 'Melanson', 'Affiliation': 'Division of Endocrinology, Metabolism, and Diabetes, Department of Medicine, University of Colorado Anschutz Medical Campus, Aurora, Colorado.'}, {'ForeName': 'Kong Y', 'Initials': 'KY', 'LastName': 'Chen', 'Affiliation': 'Diabetes, Endocrinology, and Obesity Branch, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda Maryland.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgaa350'] 2070,32485781,The Pharmacokinetics of Fluticasone Furoate Given Intranasally in Healthy Subjects Using an Ultra-Sensitive Analytical Assay.,"PURPOSE It has been previously shown that the complete pharmacokinetic profile, in particular the elimination phase, of intranasal fluticasone furoate has not been fully characterized due to the inability to quantify concentrations at low enough levels. This study was designed to evaluate the pharmacokinetic profile of intranasal FF using a validated, ultra-sensitive analytical method in healthy subjects. METHODS This was an open-label, single-dose, two-period, one-treatment, crossover study. A dose of 880 µg fluticasone furoate was administered intra nasally. Blood samples for pharmacokinetic analysis were collected at 23 time points up to 36 h and analyzed for FF plasma levels using a lower limit of quantitation (LLOQ) of 0.1 pg/mL. Medical and adverse events (AE) were monitored throughout the study. RESULTS Eighteen subjects were enrolled in and 17 completed the study. The results showed that all 17 subjects had measurable fluticasone furoate plasma concentrations at all time points with a clearly defined elimination phase, thus allowing estimation of AUC inf and t 1/2 . Median T max was 1.33 h (range=0.75-6.00), mean C max was 13.05±7.59 pg/mL, mean AUC t was 148.48±77.76 pg/mL*h, mean AUC inf was 279.07±187.81 pg/mL*h, and mean t 1/2 was 31.67±29.23 h. In total 4 subjects (22.2%) experienced 4 AEs. CONCLUSION Using a lower LLOQ than what has been previously reported, a complete characterization of intranasal fluticasone furoate pharmacokinetics, including a clearly defined terminal elimination phase, was achieved. This method will allow for further investigations into the pharmacokinetics of fluticasone furoate.",2020,"Median T max was 1.33 h (range=0.75-6.00), mean C max was 13.05±7.59 pg/mL, mean","['Eighteen subjects were enrolled in and 17 completed the study', 'healthy subjects', 'Healthy Subjects Using an Ultra-Sensitive Analytical Assay']","['fluticasone furoate', 'Fluticasone Furoate', 'intranasal FF']","['AUC inf', 'measurable fluticasone furoate plasma concentrations', 'Median T max']","[{'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0005507', 'cui_str': 'Bioassay'}]","[{'cui': 'C1948374', 'cui_str': 'fluticasone furoate'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach'}]","[{'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0666743', 'cui_str': 'infliximab'}, {'cui': 'C1948374', 'cui_str': 'fluticasone furoate'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}]",18.0,0.0300749,"Median T max was 1.33 h (range=0.75-6.00), mean C max was 13.05±7.59 pg/mL, mean","[{'ForeName': 'Mohammed', 'Initials': 'M', 'LastName': 'Bouhajib', 'Affiliation': 'Bioanalytical Laboratory, Pharma Medica Research Inc, Mississauga, Canada.'}, {'ForeName': 'Zia', 'Initials': 'Z', 'LastName': 'Tayab', 'Affiliation': 'Scientific Affairs, Pharma Medica Research Inc, Mississauga, Canada.'}]",Drug research,['10.1055/a-1170-3083'] 2071,32581041,Hyperprogression to camrelizumab in a patient with esophageal squamous cell carcinoma harboring EGFR kinase domain duplication.,"BACKGROUND Previous studies have reported that the amplification of some genes, such as Murine Double Minute 2 or 4 and Epidermal Growth Factor Receptor ( EGFR ), may be related to hyperprogressive disease (HPD). Exploring somatic gene alterations might be an effective method to predict HPD. Herein we characterize the somatic alterations in a patient with esophageal squamous cell carcinoma (ESCC) who developed HPD to investigate the potential origins of HPD. CASE PRESENTATION A man in his mid-40s was diagnosed with ESCC. After the failure of first-line treatment with cisplatin and docetaxel, the patient participated in a phase III randomized, open, multicenter clinical trial (CTR20170307) and subsequently received camrelizumab. After 4 weeks of immunotherapy, the tumor size increased by 79% compared with baseline imaging; the progressive pace was 2.5-fold higher than preimmunotherapy, and a new liver metastasis appeared. A rare EGFR exon 2-28 duplication was discovered in both preimmunotherapy and postimmunotherapy tumor tissues. CONCLUSION This is the first report on a patient with ESCC harboring rare EGFR kinase domain duplication in exons 2-28 and developing HPD in the process of camrelizumab treatment. This case suggested that EGFR kinase domain duplication might be associated with HPD. Administration of immune checkpoint inhibitor monotherapy in this subgroup of patients harboring EGFR kinase domain duplication should be performed with caution. These results need to be further confirmed in a larger cohort of patients.",2020,"After 4 weeks of immunotherapy, the tumor size increased by 79% compared with baseline imaging; the progressive pace was 2.5-fold higher than preimmunotherapy, and a new liver metastasis appeared.","['A man in his mid-40s was diagnosed with ESCC', 'patient with esophageal squamous cell carcinoma harboring EGFR kinase domain duplication', 'patient with esophageal squamous cell carcinoma (ESCC']","['Double Minute 2 or 4 and Epidermal Growth Factor Receptor ( EGFR ', 'camrelizumab', 'Hyperprogression to camrelizumab', 'cisplatin and docetaxel', 'immune checkpoint inhibitor monotherapy']","['tumor size', 'progressive pace']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0279626', 'cui_str': 'Squamous cell carcinoma of esophagus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0475311', 'cui_str': 'Harbor'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0031727', 'cui_str': 'Kinase'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0332597', 'cui_str': 'Duplication'}]","[{'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C4682408', 'cui_str': 'camrelizumab'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0439662', 'cui_str': 'Immune'}, {'cui': 'C1155874', 'cui_str': 'Cell Cycle Checkpoints'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0475440', 'cui_str': 'Tumor size'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0287990', 'cui_str': 'Furin'}]",,0.0305784,"After 4 weeks of immunotherapy, the tumor size increased by 79% compared with baseline imaging; the progressive pace was 2.5-fold higher than preimmunotherapy, and a new liver metastasis appeared.","[{'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'Department of Oncology, Changhai Hospital of Shanghai, Shanghai, China.'}, {'ForeName': 'Meihong', 'Initials': 'M', 'LastName': 'Wu', 'Affiliation': 'Department of Oncology, Changhai Hospital of Shanghai, Shanghai, China.'}, {'ForeName': 'Minglu', 'Initials': 'M', 'LastName': 'Liu', 'Affiliation': 'Department of Radiology, Changhai Hospital of Shanghai, Shanghai, China.'}, {'ForeName': 'Zhengqing', 'Initials': 'Z', 'LastName': 'Yan', 'Affiliation': 'The Medical Department, 3D Medicines Inc, Shanghai, China.'}, {'ForeName': 'Guoqiang', 'Initials': 'G', 'LastName': 'Wang', 'Affiliation': 'The Medical Department, 3D Medicines Inc, Shanghai, China.'}, {'ForeName': 'Dongliang', 'Initials': 'D', 'LastName': 'Mao', 'Affiliation': 'Department of Oncology, North Ruijin Hospital, Shanghai Jiao Tong University, Shanghai, China.'}, {'ForeName': 'Mei', 'Initials': 'M', 'LastName': 'Wang', 'Affiliation': 'Department of Oncology, North Ruijin Hospital, Shanghai Jiao Tong University, Shanghai, China 13601810867@163.com.'}]",Journal for immunotherapy of cancer,['10.1136/jitc-2020-000793'] 2072,32581042,Serum interleukin-6 and C-reactive protein are associated with survival in melanoma patients receiving immune checkpoint inhibition.,"BACKGROUND Inflammatory mediators, including acute phase reactants and cytokines, have been reported to be associated with clinical efficacy in patients with melanoma and other cancers receiving immune checkpoint inhibitors (ICI). Analyses of patient sera from three large phase II/III randomized ICI trials, one of which included a chemotherapy arm, were performed to assess whether baseline levels of C-reactive protein (CRP), interleukin-6 (IL-6) or neutrophil/lymphocyte (N/L) ratios were prognostic or predictive. PATIENTS AND METHODS Baseline and on-treatment sera were analyzed by multiplex protein assays from immunotherapy-naïve patients with metastatic melanoma randomized 1:1 on the Checkmate-064 phase II trial of sequential administration of nivolumab followed by ipilimumab or the reverse sequence. Baseline sera, and peripheral blood mononuclear cells using automated cell counting, were analyzed from treatment-naïve patients who were BRAF wild-type and randomly allocated 1:1 to receive nivolumab or dacarbazine on the phase III Checkmate-066 trial, and from treatment-naïve patients allocated 1:1:1 to receive nivolumab, ipilimumab or both ipilimumab and nivolumab on the phase III Checkmate-067 trial. RESULTS Higher baseline levels of IL-6 and the N/L ratio, and to a lesser degree, CRP were associated with shorter survival in patients receiving ICI or chemotherapy. Increased on-treatment levels of IL-6 in patients on the Checkmate-064 study were also associated with shorter survival. IL-6 levels from patients on Checkmate-064, Checkmate-066 and Checkmate-067 were highly correlated with levels of CRP and the N/L ratio. CONCLUSION IL-6, CRP and the N/L ratio are prognostic factors with higher levels associated with shorter overall survival in patients with metastatic melanoma receiving ICI or chemotherapy in large randomized trials. In a multi-variable analysis of the randomized phase III Checkmate-067 study, IL-6 was a significant prognostic factor for survival.",2020,"RESULTS Higher baseline levels of IL-6 and the N/L ratio, and to a lesser degree, CRP were associated with shorter survival in patients receiving ICI or chemotherapy.","['melanoma patients receiving immune checkpoint inhibition', 'Baseline and on-treatment sera were analyzed by multiplex protein assays from immunotherapy-naïve patients with metastatic melanoma randomized 1:1 on the Checkmate-064 phase II trial of sequential administration of', 'patients with metastatic melanoma receiving', 'patients with melanoma and other cancers receiving immune checkpoint inhibitors (ICI', 'naïve patients who were BRAF wild-type']","['nivolumab, ipilimumab or both ipilimumab and nivolumab', 'nivolumab followed by ipilimumab', 'nivolumab or dacarbazine', 'ICI or chemotherapy']","['baseline levels of C-reactive protein (CRP), interleukin-6 (IL-6) or neutrophil/lymphocyte (N/L) ratios', 'IL-6 levels', 'overall survival', 'IL-6', 'shorter survival']","[{'cui': 'C0025202', 'cui_str': 'Malignant melanoma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439662', 'cui_str': 'Immune'}, {'cui': 'C1155874', 'cui_str': 'Cell Cycle Checkpoints'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0005507', 'cui_str': 'Bioassay'}, {'cui': 'C0005525', 'cui_str': 'Modifiers, Biological Response'}, {'cui': 'C0278883', 'cui_str': 'Metastatic melanoma'}, {'cui': 'C0282460', 'cui_str': 'Clinical Trials, Phase II as Topic'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C1259929', 'cui_str': 'BRAF protein, human'}, {'cui': 'C0445392', 'cui_str': 'Wild'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C1367202', 'cui_str': 'ipilimumab'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0010927', 'cui_str': 'Dacarbazine'}, {'cui': 'C0439662', 'cui_str': 'Immune'}, {'cui': 'C1155874', 'cui_str': 'Cell Cycle Checkpoints'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear leukocyte'}, {'cui': 'C0024264', 'cui_str': 'Lymphocyte'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}]",,0.152016,"RESULTS Higher baseline levels of IL-6 and the N/L ratio, and to a lesser degree, CRP were associated with shorter survival in patients receiving ICI or chemotherapy.","[{'ForeName': 'Andressa S', 'Initials': 'AS', 'LastName': 'Laino', 'Affiliation': 'Perlmutter Cancer Center, NYU Langone Health, New York, New York, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Woods', 'Affiliation': 'Department of Medicine, University of Colorado Denver-Anschutz Medical Campus, Aurora, Colorado, USA.'}, {'ForeName': 'Melinda', 'Initials': 'M', 'LastName': 'Vassallo', 'Affiliation': 'Perlmutter Cancer Center, NYU Langone Health, New York, New York, USA.'}, {'ForeName': 'Xiaozhong', 'Initials': 'X', 'LastName': 'Qian', 'Affiliation': 'Bristol-Myers Squibb, Princeton, New Jersey, USA.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Tang', 'Affiliation': 'Bristol-Myers Squibb, Princeton, New Jersey, USA.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Wind-Rotolo', 'Affiliation': 'Bristol-Myers Squibb, Princeton, New Jersey, USA.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Weber', 'Affiliation': 'Perlmutter Cancer Center, NYU Langone Health, New York, New York, USA Jeffrey.Weber@nyulangone.org.'}]",Journal for immunotherapy of cancer,['10.1136/jitc-2020-000842'] 2073,32581524,Erratum: The Effect of Baseline Rescue Medication Use on Efficacy and Safety of Nebulized Glycopyrrolate Treatment in Patients with COPD from the GOLDEN 3 and 4 Studies [Corrigendum].,[This corrects the article DOI: 10.2147/COPD.S242767.].,2020,[This corrects the article DOI: 10.2147/COPD.S242767.].,['Patients with COPD from the GOLDEN 3 and 4 Studies [Corrigendum'],['Nebulized Glycopyrrolate'],['Efficacy and Safety'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0017970', 'cui_str': 'Glycopyrrolate'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.0383834,[This corrects the article DOI: 10.2147/COPD.S242767.].,[],International journal of chronic obstructive pulmonary disease,['10.2147/COPD.S262956'] 2074,32586143,On-treatment HDL cholesterol predicts incident atrial fibrillation in hypertensive patients with left ventricular hypertrophy.,"Purpose : Hypertensive patients are at increased risk of atrial fibrillation (AF). Although low baseline high density lipoprotein (HDL) cholesterol has been associated with a higher risk of AF, this has not been verified in recent population-based studies. Whether changing levels of HDL over time are more strongly related to the risk of new AF in hypertensive patients has not been examined. Material and methods : Incident AF was examined in relation to baseline and on-treatment HDL levels in 8267 hypertensive patients with no history of AF, in sinus rhythm on their baseline electrocardiogram, randomly assigned to losartan- or atenolol-based treatment. HDL levels at baseline and each year of testing were categorised into quartiles according to baseline HDL levels. Results : During 4.7 ± 1.10 years of follow-up, 645 patients (7.8%) developed new AF. In univariate Cox analyses, compared with the highest quartile of HDL levels (>1.78 mmol/l), patients with on-treatment HDL in the lowest quartile (≤ 1.21 mmol/l) had a 53% greater risk of new AF. Patients with on-treatment HDL in the second and third quartiles had intermediate increased risks of AF. Baseline HDL in the lowest quartile was not a significant predictor of new AF (hazard ratio (HR): 1.14, 95% confidence interval (CI): 0.90-1.43). In multivariable Cox analyses adjusting for multiple baseline and time-varying covariates, the lowest quartile of on-treatment HDL remained associated with a nearly 54% increased risk of new AF (HR: 1.54, 95% CI: 1.16-2.05) whereas a baseline HDL≤ ⩽1.21 mmol/l was not predictive of new AF (HR: 1.01, 95% CI: 0.78-1.31). Conclusion : Lower on-treatment HDL is strongly associated with risk of new AF. These findings suggest that serial assessment of HDL can estimate AF risk better than baseline HDL in hypertensive patients with left ventricular hypertrophy. Future studies may investigate whether therapies that increase HDL can lower risk of developing AF. Clinical Trials Registration : http://clinicaltrials.gov/ct/show/NCT00338260?order=1.",2020,Baseline HDL in the lowest quartile was not a significant predictor of new AF (hazard ratio (HR):,"['hypertensive patients', 'hypertensive patients with left ventricular hypertrophy', '8267 hypertensive patients with no history of AF, in sinus rhythm on their baseline electrocardiogram, randomly assigned to']","['losartan- or atenolol-based treatment', 'HDL']","['HDL levels', 'new AF', 'new AF (hazard ratio (HR', 'risk of atrial fibrillation (AF', 'risk of new AF', 'risks of AF']","[{'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0149721', 'cui_str': 'Left ventricular hypertrophy'}, {'cui': 'C0332122', 'cui_str': 'No history of'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0232201', 'cui_str': 'Sinus rhythm'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}]","[{'cui': 'C0126174', 'cui_str': 'Losartan'}, {'cui': 'C0004147', 'cui_str': 'Atenolol'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}]","[{'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",8267.0,0.0364102,Baseline HDL in the lowest quartile was not a significant predictor of new AF (hazard ratio (HR):,"[{'ForeName': 'Peter M', 'Initials': 'PM', 'LastName': 'Okin', 'Affiliation': 'Division of Cardiology, Weill Cornell Medical College, New York, NY, USA.'}, {'ForeName': 'Darcy A', 'Initials': 'DA', 'LastName': 'Hille', 'Affiliation': 'Merck Research Labs, West Point, PA, USA.'}, {'ForeName': 'Kristian', 'Initials': 'K', 'LastName': 'Wachtell', 'Affiliation': 'Department of Cardiology, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Sverre E', 'Initials': 'SE', 'LastName': 'Kjeldsen', 'Affiliation': 'Department of Cardiology, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'Stevo', 'Initials': 'S', 'LastName': 'Julius', 'Affiliation': 'Division of Cardiovascular Medicine, University of Michigan Medical Center, Ann Arbor, MI, USA.'}, {'ForeName': 'Richard B', 'Initials': 'RB', 'LastName': 'Devereux', 'Affiliation': 'Division of Cardiology, Weill Cornell Medical College, New York, NY, USA.'}]",Blood pressure,['10.1080/08037051.2020.1782171'] 2075,32586400,"Protocol for a cluster randomised trial in Madhya Pradesh, India: community health promotion and medical provision and impact on neonates (CHAMPION2); and support to rural India's public education system and impact on numeracy and literacy scores (STRIPES2).","BACKGROUND Rural areas of India exhibit high neonatal mortality, and low literacy and numeracy. We assess the effect of a complex package of health interventions on neonatal survival and the effect of out-of-school-hours teaching on children's literacy and numeracy in rural Madhya Pradesh. METHODS/DESIGN This is a cluster-randomised controlled trial with villages (clusters) receiving either a health (CHAMPION2) or education (STRIPES2) intervention. Building on the design of the earlier CHAMPION/STRIPES trial, villages receiving the health intervention are controls for the education intervention and vice versa. The clusters are 196 villages in Satna district, Madhya Pradesh, India: each is at least 5 km from a Community Health Centre, has a population below 2500, and has at least 15 children eligible for the education intervention. The participants in CHAMPION2 are resident married women younger than 50 years of age who had not undergone a family planning operation, provided they are enumerated pre-randomisation or marry a man enumerated pre-randomisation. The participants in STRIPES2 are resident children born 16 June 2010 to 15 June 2013, not in school before the 2018-2019 school year and intending to enrol in first grade in 2018-2019 or 2019-2020. DISCUSSION In CHAMPION2, the NICE Foundation will deliver a 3.5-year programme comprising Accredited Social Health Activists or village health workers and midwives promoting health knowledge and providing antenatal, postnatal, and neonatal healthcare; community mobilisation; referrals to appropriate government health facilities; and a health education campaign. In STRIPES2, the Pratham Education Foundation will deliver a programme of village-based, before/after school support focusing on literacy and numeracy. As controls, the CHAMPION2 control villages will receive the usual health services (plus the STRIPES2 intervention). STRIPES2 control villages will receive the usual education services (plus the CHAMPION2 intervention). The primary outcome in CHAMPION2 is neonatal mortality. Secondary outcomes include antenatal, delivery, immediate neonatal and postnatal care practices, maternal mortality, stillbirths, early neonatal deaths, perinatal deaths, health knowledge, hospital admissions, maternal blood transfusions, and cost effectiveness. The primary outcome in STRIPES2 is a composite literacy and numeracy test score. Secondary outcomes include separate literacy and numeracy scores, reported school enrolment and attendance, parents' engagement with children's learning, and cost effectiveness. Independent research and implementation teams will conduct the trial. Trial Steering and Data Monitoring Committees, with independent members, will supervise the trial. TRIAL REGISTRATION Clinical Trial Registry of India: CTRI/2019/05/019296. Registered on 23 May 2019. http://www.ctri.nic.in/Clinicaltrials/pdf_generate.php?trialid=31198&EncHid=&modid=&compid=%27,%2731198det%27.",2020,"Secondary outcomes include separate literacy and numeracy scores, reported school enrolment and attendance, parents' engagement with children's learning, and cost effectiveness.","['participants in CHAMPION2 are resident married women younger than 50 years of age who had not undergone a family planning operation, provided they are enumerated pre-randomisation or marry a man enumerated pre-randomisation', 'participants in STRIPES2 are resident children born 16 June 2010 to 15 June 2013, not in school before the 2018-2019 school year and intending to enrol in first grade in 2018-2019 or 2019-2020', '196 villages in Satna district, Madhya Pradesh, India: each is at least 5 km from a Community Health Centre, has a population below 2500, and has at least 15 children eligible for the education intervention', ""children's literacy and numeracy in rural Madhya Pradesh""]","['villages (clusters) receiving either a health (CHAMPION2) or education (STRIPES2) intervention', 'school-hours teaching', 'complex package of health interventions']","[""separate literacy and numeracy scores, reported school enrolment and attendance, parents' engagement with children's learning, and cost effectiveness"", 'composite literacy and numeracy test score', 'neonatal survival', 'antenatal, delivery, immediate neonatal and postnatal care practices, maternal mortality, stillbirths, early neonatal deaths, perinatal deaths, health knowledge, hospital admissions, maternal blood transfusions, and cost effectiveness', 'neonatal mortality']","[{'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0024841', 'cui_str': 'Marriage'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009861', 'cui_str': 'Family planning service'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C1283828', 'cui_str': 'Has intent'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C4517625', 'cui_str': '196'}, {'cui': 'C0562518', 'cui_str': 'Village environment'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0034019', 'cui_str': 'Community Health'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C4319601', 'cui_str': '2500'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0023864', 'cui_str': 'Literacy'}]","[{'cui': 'C0562518', 'cui_str': 'Village environment'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0013194', 'cui_str': 'Packaging, Drug'}]","[{'cui': 'C0443299', 'cui_str': 'Separate'}, {'cui': 'C0023864', 'cui_str': 'Literacy'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C2828394', 'cui_str': 'Antenatal'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0032782', 'cui_str': 'Postpartum care'}, {'cui': 'C0024923', 'cui_str': 'Maternal death'}, {'cui': 'C0595939', 'cui_str': 'Stillbirth'}, {'cui': 'C1271991', 'cui_str': 'Early neonatal death'}, {'cui': 'C0701826', 'cui_str': 'Perinatal death'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0027616', 'cui_str': 'Neonatal Mortality'}]",,0.117173,"Secondary outcomes include separate literacy and numeracy scores, reported school enrolment and attendance, parents' engagement with children's learning, and cost effectiveness.","[{'ForeName': 'Arjun', 'Initials': 'A', 'LastName': 'Agarwal', 'Affiliation': 'Pratham Education Foundation, New Delhi, India.'}, {'ForeName': 'Rukmini', 'Initials': 'R', 'LastName': 'Banerji', 'Affiliation': 'Pratham Education Foundation, New Delhi, India.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Boone', 'Affiliation': 'Effective Intervention, London, UK.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Elbourne', 'Affiliation': 'London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Ila', 'Initials': 'I', 'LastName': 'Fazzio', 'Affiliation': 'Effective Intervention, London, UK. if@effint.org.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Frost', 'Affiliation': 'London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Madan', 'Initials': 'M', 'LastName': 'Gopal', 'Affiliation': 'NICE Foundation, Hyderabad, India.'}, {'ForeName': 'Sridevi', 'Initials': 'S', 'LastName': 'Karnati', 'Affiliation': 'GH Training and Consulting, Hyderabad, India.'}, {'ForeName': 'Rakhi', 'Initials': 'R', 'LastName': 'Nair', 'Affiliation': 'NICE Foundation, Hyderabad, India.'}, {'ForeName': 'Harshavardhan', 'Initials': 'H', 'LastName': 'Reddy', 'Affiliation': 'GH Training and Consulting, Hyderabad, India.'}, {'ForeName': 'Padmanabh', 'Initials': 'P', 'LastName': 'Reddy', 'Affiliation': 'NICE Foundation, Hyderabad, India.'}, {'ForeName': 'Dropti', 'Initials': 'D', 'LastName': 'Sharma', 'Affiliation': 'Pratham Education Foundation, New Delhi, India.'}, {'ForeName': 'Sajjan Singh', 'Initials': 'SS', 'LastName': 'Shekhawat', 'Affiliation': 'Pratham Education Foundation, New Delhi, India.'}, {'ForeName': 'Siddharudha', 'Initials': 'S', 'LastName': 'Shivalli', 'Affiliation': 'London School of Hygiene and Tropical Medicine, London, UK.'}]",Trials,['10.1186/s13063-020-04339-6'] 2076,32586587,Post-Discharge Prophylaxis With Rivaroxaban Reduces Fatal and Major Thromboembolic Events in Medically Ill Patients.,"BACKGROUND Hospitalized acutely ill medical patients are at risk for fatal and major thromboembolic events. Whether use of extended-duration primary thromboprophylaxis can prevent such events is unknown. OBJECTIVES The purpose of this study was to evaluate whether extended-duration rivaroxaban reduces the risk of venous and arterial fatal and major thromboembolic events without significantly increasing major bleeding in acutely ill medical patients after discharge. METHODS MARINER (A Study of Rivaroxaban [JNJ-39039039] on the Venous Thromboembolic Risk in Post-Hospital Discharge Patients) studied acutely ill medical patients with additional risk factors for venous thromboembolism (VTE). Medically ill patients with a baseline creatinine clearance ≥50 ml/min were randomized in a double-blind fashion to rivaroxaban 10 mg or placebo daily at hospital discharge for 45 days. Exploratory efficacy analyses were performed with the intent-to-treat population including all data through day 45. Time-to-event curves were calculated using the Kaplan-Meier method. A blinded independent committee adjudicated all clinical events. RESULTS In total, 4,909 patients were assigned to rivaroxaban and 4,913 patients to placebo. The mean age was 67.8 years, 55.5% were men, mean baseline creatinine clearance was 87.8 ml/min, and mean duration of hospitalization was 6.7 days. The pre-specified composite efficacy endpoint (symptomatic VTE, myocardial infarction, nonhemorrhagic stroke, and cardiovascular death) occurred in 1.28% and 1.77% of patients in the rivaroxaban and placebo groups, respectively (hazard ratio: 0.72; 95% confidence interval: 0.52 to 1.00; p = 0.049), whereas major bleeding occurred in 0.27% and 0.18% of patients in the rivaroxaban and placebo groups, respectively (hazard ratio: 1.44; 95% confidence interval: 0.62 to 3.37; p = 0.398). CONCLUSIONS Extended-duration rivaroxaban in hospitalized medically ill patients resulted in a 28% reduction in fatal and major thromboembolic events without a significant increase in major bleeding. (A Study of Rivaroxaban [JNJ-39039039] on the Venous Thromboembolic Risk in Post-Hospital Discharge Patients [MARINER]; NCT02111564).",2020,"The pre-specified composite efficacy endpoint (symptomatic VTE, myocardial infarction, nonhemorrhagic stroke, and cardiovascular death) occurred in 1.28% and 1.77% of patients in the rivaroxaban and placebo groups, respectively (hazard ratio: 0.72; 95% confidence interval: 0.52 to 1.00; p = 0.049), whereas major bleeding occurred in 0.27% and 0.18% of patients in the rivaroxaban and placebo groups, respectively (hazard ratio: 1.44; 95% confidence interval: 0.62 to 3.37; p = 0.398). ","['Post-Hospital Discharge Patients) studied acutely ill medical patients with additional risk factors for venous thromboembolism (VTE', 'acutely ill medical patients after discharge', '4,909 patients', 'Medically\xa0Ill\xa0Patients', 'Hospitalized acutely ill medical patients', 'Medically ill patients with a baseline creatinine clearance\xa0≥50', 'hospitalized medically ill patients']","['Rivaroxaban [JNJ-39039039', 'rivaroxaban 10\xa0mg or placebo', 'Rivaroxaban', 'extended-duration rivaroxaban', 'rivaroxaban', 'Post-Discharge Prophylaxis', 'placebo']","['mean baseline creatinine clearance', 'Time-to-event curves', 'fatal and major thromboembolic events', 'risk of venous and arterial fatal and major thromboembolic events', 'Venous Thromboembolic Risk', 'major bleeding', 'pre-specified composite efficacy endpoint (symptomatic VTE, myocardial infarction, nonhemorrhagic stroke, and cardiovascular death']","[{'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0586003', 'cui_str': 'Discharge from hospital'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0231218', 'cui_str': 'Malaise'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C1861172', 'cui_str': 'Thromboembolism, Venous'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0373595', 'cui_str': 'Measurement of renal clearance of creatinine'}]","[{'cui': 'C1739768', 'cui_str': 'rivaroxaban'}, {'cui': 'C3162455', 'cui_str': 'rivaroxaban 10 MG'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0033107', 'cui_str': 'prevention & control'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0373595', 'cui_str': 'Measurement of renal clearance of creatinine'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0040038', 'cui_str': 'Thromboembolus'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0042449', 'cui_str': 'Venous structure'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C1861172', 'cui_str': 'Thromboembolism, Venous'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C3805136', 'cui_str': 'Nonhaemorrhagic stroke'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",4909.0,0.351323,"The pre-specified composite efficacy endpoint (symptomatic VTE, myocardial infarction, nonhemorrhagic stroke, and cardiovascular death) occurred in 1.28% and 1.77% of patients in the rivaroxaban and placebo groups, respectively (hazard ratio: 0.72; 95% confidence interval: 0.52 to 1.00; p = 0.049), whereas major bleeding occurred in 0.27% and 0.18% of patients in the rivaroxaban and placebo groups, respectively (hazard ratio: 1.44; 95% confidence interval: 0.62 to 3.37; p = 0.398). ","[{'ForeName': 'Alex C', 'Initials': 'AC', 'LastName': 'Spyropoulos', 'Affiliation': 'The Donald and Barbara Zucker School of Medicine and Hofstra/Northwell, The Feinstein Institute for Medical Research, and Department of Medicine, Anticoagulation and Clinical Thrombosis Services Northwell Health at Lenox Hill Hospital, New York, New York. Electronic address: aspyropoul@northwell.edu.'}, {'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Ageno', 'Affiliation': 'Department of Medicine and Surgery, University of Insubria, Varese, Italy.'}, {'ForeName': 'Gregory W', 'Initials': 'GW', 'LastName': 'Albers', 'Affiliation': 'Stanford Stroke Center, Stanford University Medical Center, Stanford, California.'}, {'ForeName': 'C Gregory', 'Initials': 'CG', 'LastName': 'Elliott', 'Affiliation': 'Department of Medicine, Intermountain Medical Center and the University of Utah, Salt Lake City, Utah.'}, {'ForeName': 'Jonathan L', 'Initials': 'JL', 'LastName': 'Halperin', 'Affiliation': 'The Cardiovascular Institute, Mount Sinai Medical Center, New York, New York.'}, {'ForeName': 'William R', 'Initials': 'WR', 'LastName': 'Hiatt', 'Affiliation': 'University of Colorado School of Medicine, Division of Cardiology, Aurora, Colorado; CPC Clinical Research, Aurora, Colorado.'}, {'ForeName': 'Gregory A', 'Initials': 'GA', 'LastName': 'Maynard', 'Affiliation': 'University of California, Davis, Sacramento, California.'}, {'ForeName': 'P Gabriel', 'Initials': 'PG', 'LastName': 'Steg', 'Affiliation': 'Université de Paris, Assistance Publique-Hôpitaux de Paris, INSERM U-1148, Paris, France; Imperial College, Royal Brompton Hospital, London, United Kingdom.'}, {'ForeName': 'Jeffrey I', 'Initials': 'JI', 'LastName': 'Weitz', 'Affiliation': 'McMaster University and the Thrombosis and Atherosclerosis Research Institute, Hamilton, Ontario, Canada.'}, {'ForeName': 'Wentao', 'Initials': 'W', 'LastName': 'Lu', 'Affiliation': 'Janssen Research & Development, LLC, Raritan, New Jersey.'}, {'ForeName': 'Theodore E', 'Initials': 'TE', 'LastName': 'Spiro', 'Affiliation': 'Thrombosis and Hematology Therapeutic Area, Clinical Development, Pharmaceuticals, Bayer U.S. LLC, Whippany, New Jersey.'}, {'ForeName': 'Elliot S', 'Initials': 'ES', 'LastName': 'Barnathan', 'Affiliation': 'Janssen Research & Development, LLC, Raritan, New Jersey.'}, {'ForeName': 'Gary E', 'Initials': 'GE', 'LastName': 'Raskob', 'Affiliation': 'Hudson College of Public Health, The University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma.'}]",Journal of the American College of Cardiology,['10.1016/j.jacc.2020.04.071'] 2077,32586693,"Peer Companionship for Mental Health of Older Adults in Primary Care: A Pragmatic, Nonblinded, Parallel-Group, Randomized Controlled Trial.","OBJECTIVES To determine whether peer companionship delivered by an aging services agency to socially-disconnected older adult primary care patients was associated with improvement in suicidal ideation depression, anxiety, and psychological connectedness. DESIGN Pragmatic, nonblinded, parallel-group, randomized controlled trial comparing peer companionship, The Senior Connection (TSC), to care-as-usual (CAU). SETTING Lifespan, a nonmedical, community-based aging services agency. PARTICIPANTS Adult primary care patients ages 60 years or older who endorsed feelings of loneliness or being a burden on others. INTERVENTION TSC was delivered by Lifespan volunteers who provided supportive visits and phone calls in the subjects' homes. CAU involved no peer companion assignment. MEASUREMENTS The primary outcome was suicidal ideation assessed by the Geriatric Suicide Ideation Scale; secondary outcomes were depression, anxiety, and feelings of belonging and being a burden on others. Data were collected at baseline, 3-, 6-, and 12-months. RESULTS Subjects (55% female) had a mean age of 71 years. There was no difference between groups in change in suicidal ideation or belonging. Subjects randomized to TSC had greater reduction in depression (PHQ-9; 2.33 point reduction for TSC versus 1.32 for CAU, p = 0.05), anxiety (GAD-7; TSC 1.52 versus CAU 0.28, p = 0.03), and perceived burden on others (INQ; 0.46 TSC versus 0.09 CAU, p <0.01). CONCLUSIONS TSC was superior to CAU for improving depression, anxiety, and perceived burden, but not suicidal ideation. Although effect sizes were small, the low-cost and nationwide availability of peer companionship justify further examination of its effectiveness and scalability in improving mental health outcomes of socially disconnected older adults.",2020,"Subjects randomized to TSC had greater reduction in depression (PHQ-9; 2.33 point reduction for TSC versus 1.32 for CAU, p = 0.05), anxiety (GAD-7; TSC 1.52 versus CAU 0.28, p = 0.03), and perceived burden on others (INQ; 0.46 TSC versus 0.09 CAU, p <0.01). ","['socially disconnected older adults', 'Adult primary care patients ages 60 years or older who endorsed feelings of loneliness or being a burden on others', 'Older Adults in Primary Care', 'Subjects (55% female) had a mean age of 71 years', 'Lifespan, a nonmedical, community-based aging services agency', 'to socially-disconnected older adult primary care patients']","['TSC', 'Peer Companionship', 'peer companionship delivered by an aging services agency', 'TSC was delivered by Lifespan volunteers who provided supportive visits and phone calls', 'CAU', 'peer companionship, The Senior Connection (TSC), to care-as-usual (CAU']","['depression, anxiety, and perceived burden', 'anxiety', 'suicidal ideation assessed by the Geriatric Suicide Ideation Scale; secondary outcomes were depression, anxiety, and feelings of belonging and being a burden on others', 'mental health outcomes', 'suicidal ideation', 'suicidal ideation depression, anxiety, and psychological connectedness', 'depression']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0023974', 'cui_str': 'Feeling lonely'}, {'cui': 'C1278569', 'cui_str': 'WAS A'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0023980', 'cui_str': 'Longevity'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0557854', 'cui_str': 'Services'}]","[{'cui': 'C0449379', 'cui_str': 'Connection'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0023980', 'cui_str': 'Longevity'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C1720420', 'cui_str': 'Call'}]","[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0424000', 'cui_str': 'Suicidal thoughts'}, {'cui': 'C0017469', 'cui_str': 'Geriatric medicine'}, {'cui': 'C0038661', 'cui_str': 'Suicide'}, {'cui': 'C0392348', 'cui_str': 'Ideation'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C1278569', 'cui_str': 'WAS A'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}]",,0.118022,"Subjects randomized to TSC had greater reduction in depression (PHQ-9; 2.33 point reduction for TSC versus 1.32 for CAU, p = 0.05), anxiety (GAD-7; TSC 1.52 versus CAU 0.28, p = 0.03), and perceived burden on others (INQ; 0.46 TSC versus 0.09 CAU, p <0.01). ","[{'ForeName': 'Yeates', 'Initials': 'Y', 'LastName': 'Conwell', 'Affiliation': 'Department of Psychiatry (YC, KVO, and CP), University of Rochester School of Medicine, Rochester, NY. Electronic address: yeates_conwell@urmc.rochester.edu.'}, {'ForeName': 'Kimberly A', 'Initials': 'KA', 'LastName': 'Van Orden', 'Affiliation': 'Department of Psychiatry (YC, KVO, and CP), University of Rochester School of Medicine, Rochester, NY.'}, {'ForeName': 'Deborah M', 'Initials': 'DM', 'LastName': 'Stone', 'Affiliation': 'Division of Injury Prevention (DMS, WLKWM), Centers for Disease Control and Prevention, Atlanta, GA.'}, {'ForeName': 'Wendy LiKamWa', 'Initials': 'WL', 'LastName': 'McIntosh', 'Affiliation': 'Division of Injury Prevention (DMS, WLKWM), Centers for Disease Control and Prevention, Atlanta, GA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Messing', 'Affiliation': 'Department of Biostatistics and Computational Biology (SM, KAK), University of Rochester School of Medicine, NY.'}, {'ForeName': 'Jody', 'Initials': 'J', 'LastName': 'Rowe', 'Affiliation': 'Lifespan of Greater Rochester, Inc. (JR), NY.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Podgorski', 'Affiliation': 'Department of Psychiatry (YC, KVO, and CP), University of Rochester School of Medicine, Rochester, NY.'}, {'ForeName': 'Kimberly A', 'Initials': 'KA', 'LastName': 'Kaukeinen', 'Affiliation': 'Department of Biostatistics and Computational Biology (SM, KAK), University of Rochester School of Medicine, NY.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Tu', 'Affiliation': 'Department of Family Medicine and Public Health, Division of Biostatistics and Bioinformatics (XT), UC San Diego School of Medicine, La Jolla, CA.'}]",The American journal of geriatric psychiatry : official journal of the American Association for Geriatric Psychiatry,['10.1016/j.jagp.2020.05.021'] 2078,32584754,Communication Cues and Engagement Behavior: Identifying Advertisement Strategies to Attract Middle-Aged Adults to a Study of the Chronic Disease Self-Management Program.,"INTRODUCTION Low- and middle-income, middle-aged adults have high rates of disease and death from chronic disease, yet their participation in self-management programs is low. This may be because advertisements for such programs often target elderly, predominantly white, affluent adults. Our study used data from a parent randomized controlled trial to identify theoretically driven advertisement cues to engage low- and middle-income, middle-aged adults in the Chronic Disease Self-Management Program (CDSMP). METHODS A framework that combined the Elaboration Likelihood Model and Protection Motivation Theory was used to guide χ 2 and regression analyses to assess relationships between advertisement cue preferences and 5 stages of cognitive engagement (cue processing, cognitive appraisal of the advertised study, motivation to enroll) and behavioral engagement of study participants (enrollment and program participation). RESULTS One advertisement cue (taking control of one's future) and 1 cue combination (financial security and taking control of one's future) were significantly associated with study enrollment, as were motivation to enroll and cue processing. CONCLUSION These results can inform CDSMP recruitment efforts to better engage low- and middle-income, middle-aged adults in an effort to mitigate the disproportionate burden of chronic disease in this population.",2020,"RESULTS One advertisement cue (taking control of one's future) and 1 cue combination (financial security and taking control of one's future) were significantly associated with study enrollment, as were motivation to enroll and cue processing. ","['middle-aged adults in the Chronic Disease Self-Management Program (CDSMP', 'Attract Middle-Aged Adults']",[],[],"[{'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]",[],[],,0.030059,"RESULTS One advertisement cue (taking control of one's future) and 1 cue combination (financial security and taking control of one's future) were significantly associated with study enrollment, as were motivation to enroll and cue processing. ","[{'ForeName': 'Lindsey', 'Initials': 'L', 'LastName': 'Horrell', 'Affiliation': 'University of North Carolina at Chapel Hill, Gillings School of Global Public Health, Chapel Hill, North Carolina.'}, {'ForeName': 'George J', 'Initials': 'GJ', 'LastName': 'Knafl', 'Affiliation': 'University of North Carolina at Chapel Hill, School of Nursing, Chapel Hill, North Carolina.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Brady', 'Affiliation': 'Clarity Consulting and Communications, Atlanta, Georgia.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Lazard', 'Affiliation': 'University of North Carolina at Chapel Hill, Hussman School of Journalism and Media, Chapel Hill, North Carolina.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Linnan', 'Affiliation': 'University of North Carolina at Chapel Hill, Gillings School of Global Public Health, Chapel Hill, North Carolina.'}, {'ForeName': 'Shawn', 'Initials': 'S', 'LastName': 'Kneipp', 'Affiliation': 'University of North Carolina at Chapel Hill, School of Nursing, Chapel Hill, North Carolina.'}]",Preventing chronic disease,['10.5888/pcd17.190413'] 2079,32584828,Potentials and pitfalls of increasing prosocial behavior and self-efficacy over time using an online personalized platform.,"BACKGROUND This longitudinal mixed methods experimental study aimed to better understand the interplay between digital technology exposure over time, self-efficacy, and prosocial behavior in everyday contexts. METHODS 66 psychology students tracked their daily prosocial behavior over three weeks. Additionally, half of the participants were randomly assigned to receive access to an online platform, which made personalized suggestions for prosocial actions to complete. Qualitative post-study interviews complemented quantitative measures. RESULTS Platform exposure had no measurable impact beyond that of tracking over time on either prosocial behavior or self-efficacy. Tracking increased self-efficacy to perform everyday prosocial actions, but did not affect self-efficacy to impact change. Prosocial behavior was predicted by self-efficacy to impact change. Enjoyment of the platform predicted completing higher numbers of suggested prosocial actions and was related to a higher likelihood to continue using the platform in the future. Avenues for increasing platform effectiveness include context-specific action personalization, an effective reminder system, and better support for the development of self-efficacy to impact change through meaningful actions. CONCLUSION Technology for prosocial behavior should be enjoyable, capable of being seamlessly integrated into everyday life, and ensure that suggested actions are perceived as meaningful in order to support the sustainable development of self-efficacy and prosocial behavior over time.",2020,Enjoyment of the platform predicted completing higher numbers of suggested prosocial actions and was related to a higher likelihood to continue using the platform in the future.,['66 psychology students tracked their'],[],"['prosocial behavior and self-efficacy', 'daily prosocial behavior', 'prosocial behavior or self-efficacy', 'self-efficacy', 'Prosocial behavior']","[{'cui': 'C0033909', 'cui_str': 'Psychology'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0040594', 'cui_str': 'Track'}]",[],"[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",66.0,0.025428,Enjoyment of the platform predicted completing higher numbers of suggested prosocial actions and was related to a higher likelihood to continue using the platform in the future.,"[{'ForeName': 'Sharon T', 'Initials': 'ST', 'LastName': 'Steinemann', 'Affiliation': 'Department for General Psychology and Methodology, Faculty of Psychology, University of Basel, Basel, Basel-Stadt, Switzerland.'}, {'ForeName': 'Benjamin J', 'Initials': 'BJ', 'LastName': 'Geelan', 'Affiliation': 'Department for General Psychology and Methodology, Faculty of Psychology, University of Basel, Basel, Basel-Stadt, Switzerland.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Zaehringer', 'Affiliation': 'Department for General Psychology and Methodology, Faculty of Psychology, University of Basel, Basel, Basel-Stadt, Switzerland.'}, {'ForeName': 'Kamalatharsi', 'Initials': 'K', 'LastName': 'Mutuura', 'Affiliation': 'Department for General Psychology and Methodology, Faculty of Psychology, University of Basel, Basel, Basel-Stadt, Switzerland.'}, {'ForeName': 'Ewgenij', 'Initials': 'E', 'LastName': 'Wolkow', 'Affiliation': 'Department for General Psychology and Methodology, Faculty of Psychology, University of Basel, Basel, Basel-Stadt, Switzerland.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Frasseck', 'Affiliation': 'Department for General Psychology and Methodology, Faculty of Psychology, University of Basel, Basel, Basel-Stadt, Switzerland.'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Opwis', 'Affiliation': 'Department for General Psychology and Methodology, Faculty of Psychology, University of Basel, Basel, Basel-Stadt, Switzerland.'}]",PloS one,['10.1371/journal.pone.0234422'] 2080,32584834,Gender-differences in predictors for time to metabolic syndrome resolution: A secondary analysis of a randomized controlled trial study.,"Understanding gender differences in health-related behaviors and their impacts is a crucial aspect of effective primary care. We studied gender-based differences in predictors of metabolic syndrome (MetS) resolution among newly diagnosed MetS patients. This study was a secondary analysis of a prospective clinical trial study comprising of 637 middle-aged and older adults (226 men and 411 women) who underwent a regular health checkup and were newly diagnosed with MetS at 16 different health clinics of 14 metropolitan cities and provinces. We conducted Cox proportional hazard analysis to estimate cumulative probability of MetS resolution within a 12-month observation period. Among the 637 patients, 47.6% of participants achieved MetS resolution. The resolution rate was similar among men and women (44.7% and 49.1%, respectively, P = 0.320). Low household income (Hazard ratio = 2.62, 95% confidence interval: 1.13-6.08) and current employment (2.29, 1.26-4.13) were associated with a higher cumulative probability of MetS resolution in men than in women. For women, however, longer sleeping hours (1.18, 1.04-1.34) and living with a partner (1.58, 1.06-2.35) were positive predictors of MetS resolution. Being overweight (0.63, 0.44-0.89) was associated with lower cumulative probability of MetS resolution in women than in men. The factors associated with cumulative probability of MetS resolution within the 12-month follow-up were different between men and women. These findings facilitate further exploration on gender-based differences in risk factors for less optimal improvements in MetS.",2020,"Low household income (Hazard ratio = 2.62, 95% confidence interval: 1.13-6.08) and current employment (2.29, 1.26-4.13) were associated with a higher cumulative probability of MetS resolution in men than in women.","['637 middle-aged and older adults (226 men and 411 women) who underwent a regular health checkup and were newly diagnosed with MetS at 16 different health clinics of 14 metropolitan cities and provinces', 'newly diagnosed MetS patients']",[],"['metabolic syndrome (MetS) resolution', 'current employment', 'cumulative probability of MetS resolution', 'MetS resolution', 'resolution rate']","[{'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0260860', 'cui_str': 'General medical examination'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]",[],"[{'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0014003', 'cui_str': 'Employment'}, {'cui': 'C0033204', 'cui_str': 'Probability'}]",637.0,0.231571,"Low household income (Hazard ratio = 2.62, 95% confidence interval: 1.13-6.08) and current employment (2.29, 1.26-4.13) were associated with a higher cumulative probability of MetS resolution in men than in women.","[{'ForeName': 'Seung-Ah', 'Initials': 'SA', 'LastName': 'Choe', 'Affiliation': 'Department of Obstetrics and Gynecology, School of Medicine, CHA University, Gyunggi-do, Republic of Korea.'}, {'ForeName': 'Nan-He', 'Initials': 'NH', 'LastName': 'Yoon', 'Affiliation': 'Department of Health Administration, Hanyang Cyber University, Seoul, Republic of Korea.'}, {'ForeName': 'Seunghyun', 'Initials': 'S', 'LastName': 'Yoo', 'Affiliation': 'Department of Public Health Science, Graduate School of Public Health, Seoul National University, Seoul, Republic of Korea.'}, {'ForeName': 'Hyekyeong', 'Initials': 'H', 'LastName': 'Kim', 'Affiliation': 'Department of Health Convergence, Ewha Womans University, Seoul, Republic of Korea.'}]",PloS one,['10.1371/journal.pone.0234035'] 2081,32584881,"Effect of maternal prenatal food supplementation, gestational weight gain, and breast-feeding on infant growth during the first 24 months of life in rural Vietnam.","Growth faltering among children during the first five years of life is a common problem among low and middle-income countries. The purpose of this study was to determine the effect of a nutrient-rich, food-based supplement given to Vietnamese rural women prior to and/or during pregnancy on the growth of their infants during first 24 months of life and to identify maternal and newborn factors associated with the infant's growth. This prospective cohort study included 236 infants born to mothers who had received nutritional advice or a food supplement from pre-conception to term or from mid-gestation to term as part of a prior randomized controlled trial. Infant anthropometry and feeding information were monitored monthly and the infant weight for age Z-score (WAZ), length for age Z-score (LAZ), and weight for length Z-score (WLZ) were assessed at 6, 12, 18, and 24 months of age using mixed-effects regression modeling. Compared to the non-supplemented mothers, infants born to mothers receiving food supplementation from mid-gestation to term had significantly higher WLZ only at 18 months (p = 0.03) and did not differ in other outcomes. Supplementation from pre-conception to term did not affect infant growth at any time point during the first 24 months. In the entire study cohort, maternal height and gestational weight gain were positively associated with the infant's WAZ and LAZ from 6 to 24 months of age. Programs designed to improve gestational weight gain among women performing demanding physical work throughout a reproductive cycle may improve postnatal infant growth. Trial registration: Registered Clinical Trials.Gov: NCT01235767.",2020,Supplementation from pre-conception to term did not affect infant growth at any time point during the first 24 months.,"['236 infants born to mothers who had received nutritional advice or a food supplement from pre-conception to term or from mid-gestation to term as part of a prior randomized controlled trial', 'rural Vietnam', ""Vietnamese rural women prior to and/or during pregnancy on the growth of their infants during first 24 months of life and to identify maternal and newborn factors associated with the infant's growth""]","['maternal prenatal food supplementation, gestational weight gain, and breast-feeding', 'nutrient-rich, food-based supplement']","['maternal height and gestational weight gain', 'infant weight for age Z-score (WAZ), length for age Z-score (LAZ), and weight for length Z-score (WLZ', 'WLZ', 'gestational weight gain']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0009637', 'cui_str': 'Conception'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0444598', 'cui_str': 'Mid'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0042658', 'cui_str': 'Vietnam'}, {'cui': 'C0042660', 'cui_str': 'Vietnamese language'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0347984', 'cui_str': 'During'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}]","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C1398625', 'cui_str': 'Maternal Weight Gain'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0678695', 'cui_str': 'Nutrients'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C1398625', 'cui_str': 'Maternal Weight Gain'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C1444754', 'cui_str': 'Length'}]",236.0,0.0761669,Supplementation from pre-conception to term did not affect infant growth at any time point during the first 24 months.,"[{'ForeName': 'Phi N', 'Initials': 'PN', 'LastName': 'Quyen', 'Affiliation': 'National Institute of Nutrition, Hanoi, Vietnam.'}, {'ForeName': 'Hoang T', 'Initials': 'HT', 'LastName': 'Nga', 'Affiliation': 'National Institute of Nutrition, Hanoi, Vietnam.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Chaffee', 'Affiliation': 'University of California San Francisco, San Francisco, California, United States of America.'}, {'ForeName': 'Tu', 'Initials': 'T', 'LastName': 'Ngu', 'Affiliation': 'National Institute of Nutrition, Hanoi, Vietnam.'}, {'ForeName': 'Janet C', 'Initials': 'JC', 'LastName': 'King', 'Affiliation': ""Children's Hospital Oakland Research Institute, Oakland, California, United States of America.""}]",PloS one,['10.1371/journal.pone.0233671'] 2082,32597419,Acupuncture in the treatment of acute toxicity during and after head and neck cancer radiotherapy: Interim analysis of randomized prospective open-label trial.,"AIMS The aim of this investigator-initiated prospective randomized open-label single institutional trial is to evaluate the role of acupuncture in the treatment of acute skin and mucosal toxicity, xerostomia, and perception of taste, pain, and nausea related to curative and adjuvant (chemo)radiotherapy of head and neck cancer. This paper reports pilot data of the first 30 enrolled patients. METHODS Patients were randomized to undergo standard of care radiotherapy ± chemotherapy and support care defined by our institutional standard operating procedures alone or in the combination with acupuncture which was initiated with the first signs of any toxicity. RESULTS Fifteen patients were enrolled in both arms and all finished the treatment as planned.The median pain was significantly lower in the acupuncture arm (median 1.6 points vs. 2.5 points on a 10-item Likert scale; P=0.035) as well as duration of acute pain (median 31 days vs. 54 days; P=0.031). Patients with acupuncture had significantly shorter duration of acute skin (median 44 days vs. 109 days; P<0.001) and mucosal toxicity (median 34 days vs. 109 days; P<0.001) with no difference in grading of toxicity (median grade 1.6 vs. 1.5; P=0.701 and median grade 1.4 vs. 1.6; P=0.204 for skin and mucosa, respectively). No significant difference was found for other toxicity domains, with the exception of salivation toxicity which was significantly lower in acupuncture arm (median grade 1.3 vs. 1.7; P=0.048). CONCLUSION In this interim analysis, acupuncture leads to lower pain andfaster disappearance of skin and mucosal toxicity after (chemo)radiotherapy of head and neck cancer. Description and validation of acupuncture using scientific approaches will further enhance acceptance of this method by both patients and health care providers. TRIAL REGISTRATION Clinicaltrials.gov - NCT03751566.",2020,"Patients with acupuncture had significantly shorter duration of acute skin (median 44 days vs. 109 days; P<0.001) and mucosal toxicity (median 34 days vs. 109 days; P<0.001) with no difference in grading of toxicity (median grade 1.6 vs. 1.5; P=0.701 and median grade 1.4 vs. 1.6; P=0.204 for skin and mucosa, respectively).","['Fifteen patients were enrolled in both arms and all finished the treatment as planned', '30 enrolled patients', 'Patients', 'acute toxicity during and after head and neck cancer radiotherapy']","['acupuncture', 'care radiotherapy ± chemotherapy and support care defined by our institutional standard operating procedures alone or in the combination with acupuncture', 'Acupuncture']","['pain andfaster disappearance of skin and mucosal toxicity', 'duration of acute pain', 'median pain', 'shorter duration of acute skin', 'grading of toxicity', 'acute skin and mucosal toxicity, xerostomia, and perception of taste, pain, and nausea related to curative and adjuvant (chemo)radiotherapy of head and neck cancer', 'toxicity domains', 'mucosal toxicity', 'salivation toxicity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0230348', 'cui_str': 'Both upper arms'}, {'cui': 'C1706059', 'cui_str': 'Finish'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0278996', 'cui_str': 'Malignant tumor of head and neck'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}]","[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0205171', 'cui_str': 'Singular'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C3854395', 'cui_str': 'Mucosal toxicity'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0184567', 'cui_str': 'Acute pain'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0439593', 'cui_str': 'Short duration'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0043352', 'cui_str': 'Xerostomia'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0039336', 'cui_str': 'Finding of sense of taste'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C1276305', 'cui_str': 'Curative - procedure intent'}, {'cui': 'C0242939', 'cui_str': 'Adjuvant Radiotherapy'}, {'cui': 'C0278996', 'cui_str': 'Malignant tumor of head and neck'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0036104', 'cui_str': 'Salivary secretion'}]",30.0,0.124878,"Patients with acupuncture had significantly shorter duration of acute skin (median 44 days vs. 109 days; P<0.001) and mucosal toxicity (median 34 days vs. 109 days; P<0.001) with no difference in grading of toxicity (median grade 1.6 vs. 1.5; P=0.701 and median grade 1.4 vs. 1.6; P=0.204 for skin and mucosa, respectively).","[{'ForeName': 'Radana', 'Initials': 'R', 'LastName': 'Dymackova', 'Affiliation': 'Department of Radiation Oncology, Faculty of Medicine, Masaryk University, Kamenice 5, 625 00 Brno, Czech Republic.'}, {'ForeName': 'Tomas', 'Initials': 'T', 'LastName': 'Kazda', 'Affiliation': 'Department of Radiation Oncology, Faculty of Medicine, Masaryk University, Kamenice 5, 625 00 Brno, Czech Republic.'}, {'ForeName': 'Marek', 'Initials': 'M', 'LastName': 'Slavik', 'Affiliation': 'Department of Radiation Oncology, Faculty of Medicine, Masaryk University, Kamenice 5, 625 00 Brno, Czech Republic.'}, {'ForeName': 'Iveta', 'Initials': 'I', 'LastName': 'Selingerova', 'Affiliation': 'Regional Center for Applied Molecular Oncology (RECAMO), Masaryk Memorial Cancer Institute, Zluty kopec 7, 656 53 Brno, Czech Republic.'}, {'ForeName': 'Pavel', 'Initials': 'P', 'LastName': 'Slampa', 'Affiliation': 'Department of Radiation Oncology, Faculty of Medicine, Masaryk University, Kamenice 5, 625 00 Brno, Czech Republic.'}, {'ForeName': 'Ondrej', 'Initials': 'O', 'LastName': 'Slama', 'Affiliation': 'Department of Comprehensive Cancer Care, Faculty of Medicine, Masaryk University, Kamenice 5, 625 00 Brno, Czech Republic.'}]","Biomedical papers of the Medical Faculty of the University Palacky, Olomouc, Czechoslovakia",['10.5507/bp.2020.021'] 2083,32597548,"Randomized Trial of an Intensified, Multifactorial Intervention in Patients with Advanced Stage of Diabetic Kidney Disease: Diabetic Nephropathy Remission and Regression Team Trial in Japan (DNETT-Japan).","AIMS/INTRODUCTION We evaluated the efficacy of multifactorial intensive treatment (IT) on renal outcomes in patients with type 2 diabetes and advanced stage of diabetic kidney disease (DKD). MATERIALS AND METHODS Diabetic Nephropathy Remission and Regression Team Trial in Japan (DNETT-Japan) is a multi-centered, open-labeled, randomized controlled trial with a 5-year follow-up. We randomly assigned 164 patients with advanced stage of DKD (urinary albumin-to-creatinine ratio ≥300 mg/g creatinine, serum creatinine level: 1.2-2.5 mg/dl in male and 1.0-2.5 mg/dl in female) to receive either IT or conventional treatment (CT). The primary composite outcome was end stage kidney failure, doubling of serum creatinine, or death from any cause, which was assessed in the intention-to treat population. RESULTS The IT tended to reduce the risk of primary endpoints as compared to CT, but the difference between treatment groups did not reach the statistically significant level (hazard ratio (HR), 0.69; 95% confidence interval [CI], 0.43 to 1.11; P=0.13). Meanwhile, the decrease in serum LDL cholesterol level and the use of statin were significantly associated with the decrease in primary outcome (HR, 1.14; 95% CI, 1.05 to 1.23; p<0.001 and HR, 0.53; 95% CI, 0.28 to 0.998; p<0.05, respectively). The incidence of adverse events was not different between treatment groups. CONCLUSIONS The risk of kidney events tended to decrease by IT although it was not statistically significant. Lipid control using statin was associated with lower risk of kidney event. Further follow-up study may show the effect of IT in patients with advanced DKD.",2020,"The IT tended to reduce the risk of primary endpoints as compared to CT, but the difference between treatment groups did not reach the statistically significant level (hazard ratio (HR), 0.69; 95% confidence interval [CI], 0.43 to 1.11; P=0.13).","['Diabetic Nephropathy Remission and Regression Team Trial in Japan (DNETT-Japan', '164 patients with advanced stage of DKD (urinary albumin-to-creatinine ratio ≥300', 'patients with advanced DKD', 'Patients with Advanced Stage of Diabetic Kidney Disease', 'patients with type 2 diabetes and advanced stage of diabetic kidney disease (DKD']","['Intensified, Multifactorial Intervention', 'IT or conventional treatment (CT', 'multifactorial intensive treatment (IT']","['renal outcomes', 'risk of kidney events', 'adverse events', 'serum LDL cholesterol level', 'stage kidney failure, doubling of serum creatinine, or death from any cause, which was assessed in the intention-to treat population']","[{'cui': 'C0011881', 'cui_str': 'Kidney disorder due to diabetes mellitus'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0684321', 'cui_str': 'Regression - mental defense mechanism'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}]","[{'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0428474', 'cui_str': 'Serum LDL cholesterol measurement'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0035078', 'cui_str': 'Renal insufficiency'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0032659', 'cui_str': 'Population'}]",164.0,0.147588,"The IT tended to reduce the risk of primary endpoints as compared to CT, but the difference between treatment groups did not reach the statistically significant level (hazard ratio (HR), 0.69; 95% confidence interval [CI], 0.43 to 1.11; P=0.13).","[{'ForeName': 'Kenichi', 'Initials': 'K', 'LastName': 'Shikata', 'Affiliation': 'Center for Innovative Clinical Medicine, Okayama University Hospital, Okayama, Japan.'}, {'ForeName': 'Masakazu', 'Initials': 'M', 'LastName': 'Haneda', 'Affiliation': 'Division of Metabolism and Biosystemic Science, Department of Medicine, Asahikawa Medical University, Asahikawa, Japan.'}, {'ForeName': 'Toshiharu', 'Initials': 'T', 'LastName': 'Ninomiya', 'Affiliation': 'Department of Epidemiology and Public Health, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.'}, {'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Koya', 'Affiliation': 'Department of Diabetology & Endocrinology, Kanazawa Medical University, Ishikawa, Japan.'}, {'ForeName': 'Yoshiki', 'Initials': 'Y', 'LastName': 'Suzuki', 'Affiliation': 'Health Administration Center, Niigata University, Niigata, Japan.'}, {'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Suzuki', 'Affiliation': 'Suzuki Diabetes Clinic, Kanagawa, Japan.'}, {'ForeName': 'Hitoshi', 'Initials': 'H', 'LastName': 'Ishida', 'Affiliation': 'Research Center for Health Care, Nagahama City Hospital, Shiga, Japan.'}, {'ForeName': 'Hiroaki', 'Initials': 'H', 'LastName': 'Akai', 'Affiliation': 'Division of Metabolism and Diabetes, Tohoku Medical and Pharmaceutical University, Fukumuro, Miyagino-ku, Sendai, Miyagi, Japan.'}, {'ForeName': 'Yasuhiko', 'Initials': 'Y', 'LastName': 'Tomino', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine, Juntendo University, Faculty of Medicine, Hongo, Bunkyo-ku, Tokyo, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Uzu', 'Affiliation': 'Division of Nephrology, Department of Medicine, Nippon Life Hospital, Osaka, Japan.'}, {'ForeName': 'Motonobu', 'Initials': 'M', 'LastName': 'Nishimura', 'Affiliation': 'National Hospital Organization Chibahigashi Chiba-East National Hospital, Chiba, Japan.'}, {'ForeName': 'Shiro', 'Initials': 'S', 'LastName': 'Maeda', 'Affiliation': 'Department of Advanced Genomic and Laboratory Medicine, Graduate School of Medicine, University of the Ryukyu, Okinawa, Japan.'}, {'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Ogawa', 'Affiliation': 'Okayama Diabetes and Neurology Clinic, Okayama, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Miyamoto', 'Affiliation': 'Center for Innovative Clinical Medicine, Okayama University Hospital, Okayama, Japan.'}, {'ForeName': 'Hirofumi', 'Initials': 'H', 'LastName': 'Makino', 'Affiliation': 'Okayama University, Kita-ku, Tsushima, Okayama, Japan.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of diabetes investigation,['10.1111/jdi.13339'] 2084,32597565,Sequential nephron blockade with combined diuretics improves diastolic function in patients with resistant hypertension.,"AIMS Hypertension is a major contributor to cardiac diastolic dysfunction. Different therapeutics strategies have been proposed to control blood pressure (BP), but their independent impact on cardiac function remains undetermined. In patients with resistant hypertension, we compared the changes in cardiac parameters between two strategies based on sequential nephron blockade (NBD) with a combination of diuretics or sequential renin-angiotensin system blockade (RASB). METHODS AND RESULTS After a 4-week period where all patients received Irbesartan 300 mg/day + hydrochlorothiazide 12.5 mg/day + amlodipine 5 mg/day, 140 resistant hypertension patients (54.8 ± 11.1 years, 76% men, mean duration with hypertension: 13.1 ± 10.5 years, no previous history of heart failure or current symptoms of congestive heart failure) were randomized 1:1 to the NBD regimen or to the RASB regimen at week 0 (W0, baseline). Treatment intensity was increased at week 4, 8, or 10 if home BP was ≥135/85 mmHg, by sequentially adding 25 mg spironolactone, 20-40 mg furosemide, and 5 mg amiloride (NBD group) or 5-10 mg ramipril and 5-10 mg bisoprolol (RASB group). No other antihypertensive drug was allowed during the study. BP, BNP levels, and echocardiographic parameters were assessed at weeks 0 and 12. The baseline characteristics, laboratory parameters, and plasma hormones (BNP, renin, and aldosterone) and cardiac echocardiographic parameters did not significantly differ between the NBD and the RASB groups. Over 12 weeks, BNP levels significantly decreased in NBD but increased in RASB (mean [CI 95%] change in log-transformed BNP levels: -43% [-67%; -23%] vs. +55% [46%; 62%] in NBD vs. RASB, respectively, P < 0.0001). Similarly, the proportion of patients presenting ≥2 echocardiographic criteria of diastolic dysfunction decreased between baseline and W12 from 31% to 3% in NBD but increased from 19% to 32% in RASB (P = 0.0048). As compared with RASB, NBD induced greater decrease in ambulatory systolic BP (P < 0.0001), pulse pressure (P < 0.0001), and systemic vascular resistance (P < 0.005). In multivariable linear regression analyses, NBD treatment was significantly associated with decreased BNP levels (adjusted ß: -46.41 ± 6.99, P < 0.0001) independent of age, gender, renal function, and changes in BPs or heart rate. CONCLUSIONS In patients with resistant hypertension, nephron blockade with a combination of diuretics significantly improves cardiac markers of diastolic dysfunction independently of BP lowering.",2020,"In multivariable linear regression analyses, NBD treatment was significantly associated with decreased BNP levels (adjusted ß: -46.41 ± 6.99, P ","['140 resistant hypertension patients (54.8\xa0±\xa011.1\xa0years, 76% men, mean duration with hypertension: 13.1\xa0±\xa010.5\xa0years, no previous history of heart failure or current symptoms of congestive heart failure', 'patients with resistant hypertension, nephron blockade with a combination of', 'patients with resistant hypertension']","['spironolactone', 'Irbesartan 300\xa0mg/day\xa0+\xa0hydrochlorothiazide 12.5\xa0mg/day\xa0+\xa0amlodipine', 'furosemide, and 5\xa0mg amiloride (NBD group) or 5-10\xa0mg ramipril', 'diuretics', 'diuretics or sequential renin-angiotensin system blockade (RASB', 'RASB, NBD', 'combined diuretics']","['BP, BNP levels, and echocardiographic parameters', 'BNP levels', 'RASB', 'pulse pressure', 'age, gender, renal function, and changes in BPs or heart rate', 'proportion of patients presenting ≥2 echocardiographic criteria of diastolic dysfunction', 'systemic vascular resistance', 'baseline characteristics, laboratory parameters, and plasma hormones (BNP, renin, and aldosterone) and cardiac echocardiographic parameters', 'cardiac markers of diastolic dysfunction', 'control blood pressure (BP', 'diastolic function', 'ambulatory systolic BP']","[{'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0745130', 'cui_str': 'Resistant hypertensive disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C4517521', 'cui_str': '10.5'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0455531', 'cui_str': 'H/O: heart failure'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0018802', 'cui_str': 'Congestive heart failure'}, {'cui': 'C0027713', 'cui_str': 'Nephron structure'}, {'cui': 'C0332206', 'cui_str': 'Blocking'}]","[{'cui': 'C0037982', 'cui_str': 'Spironolactone'}, {'cui': 'C0986850', 'cui_str': 'irbesartan 300 MG'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0986524', 'cui_str': 'Hydrochlorothiazide 12.5 MG'}, {'cui': 'C0051696', 'cui_str': 'Amlodipine'}, {'cui': 'C0016860', 'cui_str': 'Furosemide'}, {'cui': 'C0002502', 'cui_str': 'Amiloride'}, {'cui': 'C0027713', 'cui_str': 'Nephron structure'}, {'cui': 'C0332206', 'cui_str': 'Blocking'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0072973', 'cui_str': 'Ramipril'}, {'cui': 'C0012798', 'cui_str': 'Diuretic'}, {'cui': 'C0035094', 'cui_str': 'Renin'}, {'cui': 'C0003018', 'cui_str': 'Angiotensin'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0054015', 'cui_str': 'Nesiritide'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0035094', 'cui_str': 'Renin'}, {'cui': 'C0003018', 'cui_str': 'Angiotensin'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0332206', 'cui_str': 'Blocking'}, {'cui': 'C0949236', 'cui_str': 'Pulse Pressure'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1849718', 'cui_str': 'Autosomal recessive popliteal pterygium syndrome'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0520863', 'cui_str': 'Diastolic dysfunction'}, {'cui': 'C1258192', 'cui_str': 'Systemic vascular resistance'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0002006', 'cui_str': 'Aldosterone'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C1271630', 'cui_str': 'Cardiac markers'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}]",,0.0396228,"In multivariable linear regression analyses, NBD treatment was significantly associated with decreased BNP levels (adjusted ß: -46.41 ± 6.99, P ","[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Fouassier', 'Affiliation': ""Centre d'Investigations Cliniques CIC1418, AP-HP, Hôpital Européen Georges Pompidou, Paris, France.""}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Blanchard', 'Affiliation': ""Centre d'Investigations Cliniques CIC1418, AP-HP, Hôpital Européen Georges Pompidou, Paris, France.""}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Fayol', 'Affiliation': ""Centre d'Investigations Cliniques CIC1418, AP-HP, Hôpital Européen Georges Pompidou, Paris, France.""}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Bobrie', 'Affiliation': 'Assistance Publique Hôpitaux de Paris, Hypertension unit, Hôpital Européen Georges Pompidou, Paris, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Boutouyrie', 'Affiliation': 'Paris Cardiovascular Research Center PARCC, INSERM, Université de Paris, Paris, France.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Azizi', 'Affiliation': ""Centre d'Investigations Cliniques CIC1418, AP-HP, Hôpital Européen Georges Pompidou, Paris, France.""}, {'ForeName': 'Jean-Sébastien', 'Initials': 'JS', 'LastName': 'Hulot', 'Affiliation': ""Centre d'Investigations Cliniques CIC1418, AP-HP, Hôpital Européen Georges Pompidou, Paris, France.""}]",ESC heart failure,['10.1002/ehf2.12832'] 2085,32597570,Promoting dietary awareness: Home-dwelling older adults' perspectives on using a nutrition application.,"AIMS AND OBJECTIVES This study investigated older adults' experiences of using the Appetitus app with support from healthcare professionals. BACKGROUND Good nutrition status is important for good health when ageing. However, as undernutrition remains a prevalent and persistent problem among older adults, the study explored whether technology affords innovative support for nutritional self-care among older adults. DESIGN The study was explorative and qualitative in approach. METHODS Appetitus was developed as a tablet-based application to prevent and alleviate undernutrition among older adults. Eighteen home-dwelling older adults used the app for 8 weeks. Older adults received home care, and local healthcare professionals introduced the app and gave support during the study. RESULTS Appetitus served as a source of inspiration and a reminder of available, relevant food options. Appetitus encouraged some participants to eat or drink more by the end of the day while others became more aware of selecting food options to ensure sufficient protein, energy and fluids. However, some participants made no active effort to change their diet despite feedback from the app that suggested they did not eat or drink enough. Technical support from healthcare professionals facilitated participants' use of the app and tablet. Some participants also received more specific nutritional follow-up that helped to make their experience of using the app more meaningful. CONCLUSION Older adults' awareness about the importance of keeping a diet that helps prevent undernutrition was reinforced through the use of Appetitus and discussing nutrition with healthcare professionals. IMPLICATION FOR PRACTICE The findings affirm feasibility of using technology in nutritional interventions enhancing self-care among older adults.",2020,"Appetitus encouraged some participants to eat or drink more by the end of the day while others became more aware of selecting food options to ensure sufficient protein, energy and fluids.","['older adults', ""older adults' experiences of using the Appetitus app with support from healthcare professionals"", 'Older adults received home care, and local healthcare professionals introduced the app and gave support during the study', 'Eighteen home-dwelling older adults', 'dwelling older adults']",[],[],"[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0204977', 'cui_str': 'Home care of patient'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C1292748', 'cui_str': 'Introduces'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}]",[],[],18.0,0.015188,"Appetitus encouraged some participants to eat or drink more by the end of the day while others became more aware of selecting food options to ensure sufficient protein, energy and fluids.","[{'ForeName': 'Caroline Farsjø', 'Initials': 'CF', 'LastName': 'Aure', 'Affiliation': 'Faculty of Medicine, Institute of Health and Society, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Kluge', 'Affiliation': 'Department of Education, Faculty of Educational Sciences, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Moen', 'Affiliation': 'Faculty of Medicine, Institute of Health and Society, University of Oslo, Oslo, Norway.'}]",International journal of older people nursing,['10.1111/opn.12332'] 2086,32597615,The effect of four weeks of plyometric training on reactive strength index and leg stiffness is sport dependent.,"BACKGROUND Plyometric exercises are often used to develop lower limb strength and performance-related biomechanics such as leg stiffness. However, the effectiveness of plyometric training may depend on participants' own training and performance demands. The purpose of this study was to examine the effect of plyometric training on Reactive Strength Index (RSI) and leg stiffness (Kleg) on young athletes of different sports. METHODS Forty eight female athletes (25 Taekwondo (TKD) and 23 rhythmic gymnastics (RG), mean±SD: age: 8.94±2.50 years; mass: 29.73±7.69 kg; height: 138.84±11.90 cm; training experience: 4.62±2.37 years) participated in this study. Participants were randomly assigned to experimental (PT, N.=24) and control (CG, N.=24) groups. The PT group followed a twice-weekly plyometric training program for 4 weeks. Plyometric drills lasted approximately 5-10 s, and at least 90 s rest was allowed after each set. To examine RSI, participants performed trials of five maximal CMJs. Submaximal hopping (20 hops) was performed in order to examine leg stiffness. RESULTS Significant interaction effect was found for RSI and the post hoc analysis showed that RSI significantly increased by 35% (P=0.017) in RG athletes, whereas a significantly reduction by 28% (P=0.004) was revealed in TKD athletes. The interaction effect between time and group was statistically significant for Kleg (P<0.05) with Kleg significantly increasing by 31% (P=0.008) in TKD athletes, but remaining unchanged (P>0.05) in RG athletes. CONCLUSIONS The results showed that the effect of a 4-week plyometric training program on RSI and leg stiffness is sport dependent. Further, the applied plyometric program was effective in reducing ground contact time and therefore increasing leg stiffness.",2020,"The interaction effect between time and group was statistically significant for Kleg (P<0.05) with Kleg significantly increasing by 31% (P=0.008) in TKD athletes, but remaining unchanged (P>0.05) in RG athletes. ","['young athletes of different sports', 'Forty eight female athletes (25 Taekwondo (TKD) and 23 rhythmic gymnastics (RG), mean±SD: age: 8.94±2.50 years; mass: 29.73±7.69 kg; height: 138.84±11.90 cm; training experience: 4.62±2.37 years) participated in this study']","['Plyometric exercises', 'plyometric training', 'plyometric training program']","['RSI', 'RSI and leg stiffness', 'ground contact time and therefore increasing leg stiffness', 'reactive strength index and leg stiffness', 'Reactive Strength Index (RSI) and leg stiffness (Kleg']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0038039', 'cui_str': 'Sport'}, {'cui': 'C4319608', 'cui_str': '48'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0018409', 'cui_str': 'Gymnastics'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C3178799', 'cui_str': 'Plyometric Drill'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0205332', 'cui_str': 'Reactive'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205217', 'cui_str': 'Increased'}]",48.0,0.0131781,"The interaction effect between time and group was statistically significant for Kleg (P<0.05) with Kleg significantly increasing by 31% (P=0.008) in TKD athletes, but remaining unchanged (P>0.05) in RG athletes. ","[{'ForeName': 'George C', 'Initials': 'GC', 'LastName': 'Dallas', 'Affiliation': 'School of Physical Education and Sport Science, National and Kapodistrian University of Athens, Athens, Greece - gdallas@phed.uoa.gr.'}, {'ForeName': 'Panagiotis', 'Initials': 'P', 'LastName': 'Pappas', 'Affiliation': 'School of Physical Education and Sport Science, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Constantinos G', 'Initials': 'CG', 'LastName': 'Ntallas', 'Affiliation': 'School of Physical Education and Sport Science, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Giorgos P', 'Initials': 'GP', 'LastName': 'Paradisis', 'Affiliation': 'School of Physical Education and Sport Science, National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Timothy A', 'Initials': 'TA', 'LastName': 'Exell', 'Affiliation': 'School of Sport, Health and Exercise Science, University of Portsmouth, Portsmouth, UK.'}]",The Journal of sports medicine and physical fitness,['10.23736/S0022-4707.20.10384-0'] 2087,32597616,"Does rest interval between sets affect resistance training volume, density, and rating of perceived exertion when adopting the crescent pyramid system in young women?","BACKGROUND The rest interval between sets can affect the responses to resistance training. Thus, the purpose of this study was to compare the effects of different rest intervals (RI) on volume, density, and rating of perceived exertion (RPE) when adopting a crescent pyramid (CP) system. METHODS Twenty young women (21.1±2.6 years, 1.59±0.06 m, 58.5±9.3 kg) participated in this study. All participants performed three experimental sessions of the leg press exercise in 5 sets until voluntary muscular failure at 60%, 65%, 70%, 75%, and 80% of one-repetition maximum (1RM). A randomized and crossover design was used so that in each session one of three RI (RI-1 = 1 min, RI-2 = 2 min, and RI-3 = 3 min) was tested. RESULTS The participants performed a significantly larger volume in the RI-3 (12820±3134 kg) when compared to RI-1 (10367±3053 kg) condition (P<0.05). The volume did not differ between RI-2 and RI-3 (P>0.05). The density was higher (P<0.05) in RI-1 (43.1±12.7 kg/s) when compared RI-2 (25.6±5.8 kg/s) and RI-3 (17.7±4.3 kg/s). The RI-2 presented higher density compared to RI-3 condition (P<0.05). The RPE was not different between the three conditions (P>0.05). CONCLUSIONS The use of 2 minutes of rest between sets allowed the performance of a high volume-load and density of the session in young women. In addition, the three experimental sessions provided a high perception of effort.",2020,The density was higher (P<0.05) in RI-1 (43.1±12.7 kg/s) when compared RI-2 (25.6±5.8 kg/s) and RI-3 (17.7±4.3 kg/s).,"['Twenty young women (21.1±2.6 years, 1.59±0.06 m, 58.5±9.3 kg) participated in this study', 'young women']",['leg press exercise'],"['resistance training volume, density, and rating of perceived exertion', 'volume, density, and rating of perceived exertion (RPE']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}]",20.0,0.0268077,The density was higher (P<0.05) in RI-1 (43.1±12.7 kg/s) when compared RI-2 (25.6±5.8 kg/s) and RI-3 (17.7±4.3 kg/s).,"[{'ForeName': 'Witalo', 'Initials': 'W', 'LastName': 'Kassiano', 'Affiliation': 'Metabolism, Nutrition and Exercise Laboratory, Physical Education and Sport Center, Londrina State University, Londrina, Brazil - witalokf@gmail.com.'}, {'ForeName': 'Alexandre I', 'Initials': 'AI', 'LastName': 'Medeiros', 'Affiliation': 'Federal University of Ceará (UFC), Fortaleza, Brazil.'}, {'ForeName': 'Bruna D', 'Initials': 'BD', 'LastName': 'de Vasconcelos Costa', 'Affiliation': 'Metabolism, Nutrition and Exercise Laboratory, Physical Education and Sport Center, Londrina State University, Londrina, Brazil.'}, {'ForeName': 'Ana D', 'Initials': 'AD', 'LastName': 'Andrade', 'Affiliation': 'Federal University of Paraiba (UFPB), João Pessoa, Brazil.'}, {'ForeName': 'Mário A', 'Initials': 'MA', 'LastName': 'Moura Simim', 'Affiliation': 'Federal University of Ceará (UFC), Fortaleza, Brazil.'}, {'ForeName': 'Leonardo', 'Initials': 'L', 'LastName': 'de Sousa Fortes', 'Affiliation': 'Federal University of Paraiba (UFPB), João Pessoa, Brazil.'}, {'ForeName': 'Edilson S', 'Initials': 'ES', 'LastName': 'Cyrino', 'Affiliation': 'Metabolism, Nutrition and Exercise Laboratory, Physical Education and Sport Center, Londrina State University, Londrina, Brazil.'}, {'ForeName': 'Cláudio', 'Initials': 'C', 'LastName': 'de Oliveira Assumpção', 'Affiliation': 'Federal University of Ceará (UFC), Fortaleza, Brazil.'}]",The Journal of sports medicine and physical fitness,['10.23736/S0022-4707.20.10612-1'] 2088,32597617,Effects of three different stretching protocols on hamstring muscle flexibility in professional soccer players: a randomized study.,"BACKGROUND The current study aimed to investigate and compare the influences of global postural rieducation techniques (GPR), stretching exercises on a whole-body vibration platform (WBV), and static stretching exercises on hamstrings flexibility in elite soccer players. METHODS 24 professional soccer players were randomly assigned to either global postural re-education (N.=8), stretching on whole-body vibration group (N.=8) or static stretching (N.=8), during the first 4 weeks of the precompetitive season. Assessment of hamstring muscle flexibility was performed using a straight leg raise test. All participants were assessed three times: at baseline, at the end of the study protocol and 14 days after the end of the study protocol. RESULTS The short-term increase in hamstring muscle flexibility was observed in all 3 groups, without significant differences among groups. However, after 14 days from the end of the interventions only the WBV group maintained the flexibility level achieved just at the end of the protocol with no significant changes in both legs whereas a significant decrease in the SLRT in GPR and SS groups, in right and left legs (GPR, P=0.002; P=0.015; SS, P=0.0001; P=0.0001), was observed. CONCLUSIONS These results would suggest that GPR, static stretching on whole-body vibration and static stretching techniques all improve hamstring muscle flexibility, but only stretching on WBV maintains the effect over time in professional soccer players.",2020,"The short-term increase in hamstring muscle flexibility was observed in all 3 groups, without significant differences among groups.","['professional soccer players', '24 professional soccer players', 'elite soccer players']","['global postural rieducation techniques (GPR), stretching exercises', 'global postural re-education (N.=8), stretching on whole-body vibration group (N.=8) or static stretching', 'stretching protocols', 'static stretching exercises']","['hamstring muscle flexibility', 'flexibility level', 'SLRT']","[{'cui': 'C0037393', 'cui_str': 'Soccer'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0205278', 'cui_str': 'Postural'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0600080', 'cui_str': 'Stretching exercises'}, {'cui': 'C0454282', 'cui_str': 'Posture training'}, {'cui': 'C0270814', 'cui_str': 'Spastic syndrome'}, {'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C0455941', 'cui_str': 'Vibration - treatment'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1720875', 'cui_str': 'Static Stretching'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",24.0,0.014341,"The short-term increase in hamstring muscle flexibility was observed in all 3 groups, without significant differences among groups.","[{'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'Manzi', 'Affiliation': 'IRCCS San Raffaele Pisana, Rome, Italy.'}, {'ForeName': 'Ferdinando', 'Initials': 'F', 'LastName': 'Iellamo', 'Affiliation': 'IRCCS San Raffaele Pisana, Rome, Italy.'}, {'ForeName': 'Anas R', 'Initials': 'AR', 'LastName': 'Alashram', 'Affiliation': 'Department of Medicine Systems, Faculty of Medicine and Surgery, Tor Vergata University, Rome, Italy.'}, {'ForeName': 'Rosario', 'Initials': 'R', 'LastName': ""D'onofrio"", 'Affiliation': 'Scientific Society of Sport Rehabilitation and Posturology, Rome, Italy.'}, {'ForeName': 'Elvira', 'Initials': 'E', 'LastName': 'Padua', 'Affiliation': 'Department of Human Sciences and Promotion of the Quality of Life, San Raffaele University, Rome, Italy.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Casasco', 'Affiliation': 'Federazione Italiana Medicina dello Sport (FMSI), Rome, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Annino', 'Affiliation': 'Department of Human Sciences and Promotion of the Quality of Life, San Raffaele University, Rome, Italy - g_annino@hotmail.com.'}]",The Journal of sports medicine and physical fitness,['10.23736/S0022-4707.20.10562-0'] 2089,32597619,"Creatine supplementation improves performance, but is it safe? Double-blind placebo-controlled study.","BACKGROUND Creatine represents a natural supplement and ergogenic aid for sport performance, but there are several concerns regarding its safety for health. The present double-blind placebo-controlled study evaluated the effect of creatine monohydrate supplementation on a panel of blood and urine health indicators in resistance training practitioners. METHODS Eighteen males performing resistance training three times per week were supplemented with 0.3 g/kg per day creatine monohydrate for 7 days and compared with matched controls supplemented with dextrosol. Blood and urine samples were collected pre- and 30 days post-supplementation to evaluate 41 biochemical parameters and renal function. RESULTS Creatine monohydrate supplementation did not cause adverse events and, as expected, promoted an increase of the performance and body weight. No modification of red blood cells parameters, white blood cells profile, blood lipid profile, metabolic and urine markers, hepatic and renal function were observed in the supplemented group. CONCLUSIONS Despite the expected weight increase, the creatine monohydrate supplementation is safe for health and no detrimental effects on different organs and physiological systems were observed in our cohort of volunteers.",2020,"Despite the expected weight increase, the creatine monohydrate supplementation is safe for health and no detrimental effects on different organs and physiological systems were observed in our cohort of volunteers.","['Eighteen males performing', 'resistance training practitioners']","['resistance training three times per week were supplemented with 0.3 g/kg per day creatine monohydrate for 7 days and compared with matched controls supplemented with dextrosol', 'Creatine supplementation', 'creatine monohydrate supplementation', 'placebo']","['performance and body weight', 'red blood cells parameters, white blood cells profile, blood lipid profile, metabolic and urine markers, hepatic and renal function']","[{'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}]","[{'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C4068885', 'cui_str': '0.3'}, {'cui': 'C1300563', 'cui_str': 'g/kg'}, {'cui': 'C0439505', 'cui_str': '/day'}, {'cui': 'C0873188', 'cui_str': 'Creatine monohydrate'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0010286', 'cui_str': 'Creatine'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0014772', 'cui_str': 'Red blood cell count'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}]",18.0,0.265685,"Despite the expected weight increase, the creatine monohydrate supplementation is safe for health and no detrimental effects on different organs and physiological systems were observed in our cohort of volunteers.","[{'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Almeida', 'Affiliation': 'Laboratory of Physiology and Biokinetic, Faculty of Biological Sciences and Health, UNIG Campus V, Itaperuna, Brazil.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Colombini', 'Affiliation': 'Orthopedic Biotechnology Lab, IRCCS Istituto Ortopedico Galeazzi, Milan, Italy - alessandra.colombini@grupposandonato.it.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Machado', 'Affiliation': 'Laboratory of Physiology and Biokinetic, Faculty of Biological Sciences and Health, UNIG Campus V, Itaperuna, Brazil.'}]",The Journal of sports medicine and physical fitness,['10.23736/S0022-4707.20.10437-7'] 2090,32597621,Effects of acute cooling on cycling anaerobic exercise performance and neuromuscular activity: a randomized crossover study.,"BACKGROUND While cryotherapy is known for its favorable long-term recovery effects on muscle-damaging eccentric and plyometric exercises, studies showed that cryotherapy when used as an acute recovery mode (same day) had a negligible or negative effect on high-intensity and explosive exercises. However, there is lack of evidence regarding the mechanisms underlying the detrimental effect of acute cooling on the anaerobic performance. We hypothesized that acute cooling for the lower body would reduce anaerobic power output during a subsequent WAnT, which is at least in part due to decreased neuromuscular firing rate as indexed by mean frequency. METHODS We performed a randomized crossover design experiment. 11 young healthy males completed two consecutive 30-sec Wingate anaerobic tests (WAnT 1 and 2). Subjects rested for 10 min between the WAnT 1 and the WAnT 2. Neuromuscular activity on the rectus femoris of both legs was recorded using wireless electromyography (EMG) during WAnT. RESULTS Anaerobic power during the first 5 sec of WAnT 2 was decreased in the cooling suit recovery group relative to WAnT 1. MNF in WAnT 2 was also lower in a cooled leg during WAnT 2 during the first 10 sec when compared with WAnT 1. CONCLUSIONS Acute cooling application blunts the initial phase of anaerobic power output during a subsequent WAnT, which could be explained by a concomitant reduction in neuromuscular firing rate. Given that cryotherapy is widely utilized in a variety of sports, athletes and trainers should pay close attention to the appropriate application of cryotherapy.",2020,"MNF in WAnT 2 was also lower in a cooled leg during WAnT 2 during the first 10 sec when compared with WAnT 1. ",['11 young healthy males'],"['acute cooling', 'cryotherapy']",['cycling anaerobic exercise performance and neuromuscular activity'],"[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C4551716', 'cui_str': 'Cryotherapy'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",11.0,0.0486034,"MNF in WAnT 2 was also lower in a cooled leg during WAnT 2 during the first 10 sec when compared with WAnT 1. ","[{'ForeName': 'Suk Won', 'Initials': 'SW', 'LastName': 'Kim', 'Affiliation': 'Motion Analysis Laboratory, Department of Physical Education, Jeonbuk National University, Jeonju-si, Jeollabuk-do, South Korea.'}, {'ForeName': 'Chansol', 'Initials': 'C', 'LastName': 'Hurr', 'Affiliation': 'Integrative Exercise Physiology Laboratory, Department of Physical Education, Jeonbuk National University, Jeonju-si, Jeollabuk-do South Korea - chansolh@jbnu.ac.kr.'}]",The Journal of sports medicine and physical fitness,['10.23736/S0022-4707.20.11044-2'] 2091,32597737,Micro-level de-coupling of negative affect and binge eating in relationship to macro-level outcomes in binge eating disorder treatment.,"BACKGROUND While negative affect reliably predicts binge eating, it is unknown how this association may decrease or 'de-couple' during treatment for binge eating disorder (BED), whether such change is greater in treatments targeting emotion regulation, or how such change predicts outcome. This study utilized multi-wave ecological momentary assessment (EMA) to assess changes in the momentary association between negative affect and subsequent binge-eating symptoms during Integrative Cognitive Affective Therapy (ICAT-BED) and Cognitive Behavior Therapy Guided Self-Help (CBTgsh). It was predicted that there would be stronger de-coupling effects in ICAT-BED compared to CBTgsh given the focus on emotion regulation skills in ICAT-BED and that greater de-coupling would predict outcomes. METHODS Adults with BED were randomized to ICAT-BED or CBTgsh and completed 1-week EMA protocols and the Eating Disorder Examination (EDE) at pre-treatment, end-of-treatment, and 6-month follow-up (final N = 78). De-coupling was operationalized as a change in momentary associations between negative affect and binge-eating symptoms from pre-treatment to end-of-treatment. RESULTS There was a significant de-coupling effect at follow-up but not end-of-treatment, and de-coupling did not differ between ICAT-BED and CBTgsh. Less de-coupling was associated with higher end-of-treatment EDE global scores at end-of-treatment and higher binge frequency at follow-up. CONCLUSIONS Both ICAT-BED and CBTgsh were associated with de-coupling of momentary negative affect and binge-eating symptoms, which in turn relate to cognitive and behavioral treatment outcomes. Future research is warranted to identify differential mechanisms of change across ICAT-BED and CBTgsh. Results also highlight the importance of developing momentary interventions to more effectively de-couple negative affect and binge eating.",2020,"Less de-coupling was associated with higher end-of-treatment EDE global scores at end-of-treatment and higher binge frequency at follow-up. ","['Adults with BED', 'binge eating disorder treatment']","['multi-wave ecological momentary assessment (EMA', 'Integrative Cognitive Affective Therapy (ICAT-BED) and Cognitive Behavior Therapy Guided Self-Help (CBTgsh', 'ICAT-BED or CBTgsh and completed 1-week EMA protocols and the Eating Disorder Examination (EDE', 'CBTgsh']","['binge-eating symptoms', 'binge frequency']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0596170', 'cui_str': 'Binge eating disorder'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C4277684', 'cui_str': 'Ecological Momentary Assessment'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0596170', 'cui_str': 'Binge eating disorder'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C1442452', 'cui_str': 'One week'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C2732388', 'cui_str': 'Eating disorder examination'}]","[{'cui': 'C0006370', 'cui_str': 'Binge Eating'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0596170', 'cui_str': 'Binge eating disorder'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}]",78.0,0.0216115,"Less de-coupling was associated with higher end-of-treatment EDE global scores at end-of-treatment and higher binge frequency at follow-up. ","[{'ForeName': 'Kathryn E', 'Initials': 'KE', 'LastName': 'Smith', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Southern California, Los Angeles, California, US.'}, {'ForeName': 'Tyler B', 'Initials': 'TB', 'LastName': 'Mason', 'Affiliation': 'Department of Preventive Medicine, University of Southern California, Los Angeles, California, USA.'}, {'ForeName': 'Lauren M', 'Initials': 'LM', 'LastName': 'Schaefer', 'Affiliation': 'Center for Bio-behavioral Research, Sanford Research, Fargo, North Dakota, USA.'}, {'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'Anderson', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Vivienne M', 'Initials': 'VM', 'LastName': 'Hazzard', 'Affiliation': 'Center for Bio-behavioral Research, Sanford Research, Fargo, North Dakota, USA.'}, {'ForeName': 'Ross D', 'Initials': 'RD', 'LastName': 'Crosby', 'Affiliation': 'Center for Bio-behavioral Research, Sanford Research, Fargo, North Dakota, USA.'}, {'ForeName': 'Scott G', 'Initials': 'SG', 'LastName': 'Engel', 'Affiliation': 'Center for Bio-behavioral Research, Sanford Research, Fargo, North Dakota, USA.'}, {'ForeName': 'Scott J', 'Initials': 'SJ', 'LastName': 'Crow', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Minnesota, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Stephen A', 'Initials': 'SA', 'LastName': 'Wonderlich', 'Affiliation': 'Center for Bio-behavioral Research, Sanford Research, Fargo, North Dakota, USA.'}, {'ForeName': 'Carol B', 'Initials': 'CB', 'LastName': 'Peterson', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Minnesota, Minneapolis, Minnesota, USA.'}]",Psychological medicine,['10.1017/S0033291720001804'] 2092,32597789,Assisting Home-Based Resistance Training for Normotensive and Prehypertensive Individuals Using Ambient Lighting and Sonification Feedback: Sensor-Based System Evaluation.,"BACKGROUND Physical exercise is an effective lifestyle intervention to improve blood pressure. Although aerobic sports can be performed anywhere, resistance exercises are traditionally performed at the gym; extending the latter to the home setting may promote an increase in the number of practitioners. OBJECTIVE This study aims to evaluate a sensor-based system that guides resistance exercises through ambient lighting and sonification (A/S) feedback in a home setting in 34 study participants who were normotensive and prehypertensive. METHODS Participants took part in a 1.5-hour exercise session in which they experienced the A/S feedback (ie, experimental condition) as well as a control condition (ie, no feedback) and a reference condition (ie, verbal feedback through a human remote coach). The system was evaluated for improving exercise form (range of motion, timing, and breathing patterns) as well as psychophysiological experience (perceived exertion, attentional focus, competence, and motivation). RESULTS A/S feedback was significantly better than the control for concentric (mean 2.48, SD 0.75 seconds; P<.001) and eccentric (mean 2.92, SD 1.05 seconds; P<.001) contraction times, concentric range of motion consistency (mean 15.64, SD 8.31 cm vs mean 17.94, SD 9.75 cm; P<.001), and perceived exertion (mean 3.37, SD 0.78 vs mean 3.64, SD 0.76; P<.001). However, A/S feedback did not outperform verbal feedback on any of these measures. The breathing technique was best in the control condition (ie, without any feedback). Participants did not show more positive changes in perceived competence with A/S feedback or verbal feedback. CONCLUSIONS The system seemed to improve resistance exercise execution and perception in comparison with the control, but did not outperform a human tele-coach. Further research is warranted to improve the breathing technique.",2020,"RESULTS A/S feedback was significantly better than the control for concentric (mean 2.48, SD 0.75 seconds; P<.001) and eccentric (mean 2.92, SD 1.05 seconds; P<.001) contraction times, concentric range of motion consistency (mean 15.64, SD 8.31 cm","['Participants took part in a 1.5-hour exercise session in which they experienced the A/S feedback (ie, experimental condition) as well as a control condition (ie, no feedback) and a reference condition (ie, verbal feedback through a human remote coach', 'Normotensive and Prehypertensive Individuals Using Ambient Lighting and Sonification Feedback', '34 study participants who were normotensive and prehypertensive']","['Assisting Home-Based Resistance Training', 'guides resistance exercises through ambient lighting and sonification (A/S) feedback', 'Physical exercise']","['blood pressure', 'positive changes in perceived competence with A/S feedback or verbal feedback', 'perceived exertion', 'psychophysiological experience (perceived exertion, attentional focus, competence, and motivation', 'resistance exercise execution and perception', 'contraction times, concentric range of motion consistency']","[{'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0332273', 'cui_str': 'Through'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0557773', 'cui_str': 'Coach'}, {'cui': 'C2712122', 'cui_str': 'Normal blood pressure'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1278561', 'cui_str': 'Judicial execution'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439744', 'cui_str': 'Concentric'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}]",34.0,0.0297682,"RESULTS A/S feedback was significantly better than the control for concentric (mean 2.48, SD 0.75 seconds; P<.001) and eccentric (mean 2.92, SD 1.05 seconds; P<.001) contraction times, concentric range of motion consistency (mean 15.64, SD 8.31 cm","[{'ForeName': 'Mustafa', 'Initials': 'M', 'LastName': 'Radha', 'Affiliation': 'Royal Philips, Eindhoven, Netherlands.'}, {'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'den Boer', 'Affiliation': 'Eindhoven University of Technology, Eindhoven, Netherlands.'}, {'ForeName': 'Martijn C', 'Initials': 'MC', 'LastName': 'Willemsen', 'Affiliation': 'Eindhoven University of Technology, Eindhoven, Netherlands.'}, {'ForeName': 'Thom', 'Initials': 'T', 'LastName': 'Paardekooper', 'Affiliation': 'The Hague University of Applied Sciences, The Hague, Netherlands.'}, {'ForeName': 'Wijnand A', 'Initials': 'WA', 'LastName': 'IJsselsteijn', 'Affiliation': 'Eindhoven University of Technology, Eindhoven, Netherlands.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Sartor', 'Affiliation': 'Royal Philips, Eindhoven, Netherlands.'}]",JMIR cardio,['10.2196/16354'] 2093,32597889,[Use of Detravenol in treatment of chronic venous insufficiency of lower limbs].,"AIM The purpose of this study was to prove that Detravenol is not inferior by clinical efficacy to Detralex® in the course administration in patients presenting with chronic venous insufficiency of the lower extremities caused by lower limb varicose veins. PATIENTS AND METHODS Ours was a prospective randomized open-liable comparative trial aimed at determining efficacy and safety of the two drugs in parallel groups with active control. The trial enrolled a total of 106 patients with chronic venous insufficiency of the lower extremities secondary to lower limb varicose veins. The patients took the drug during 60 days twice daily. The primary outcome measure of efficacy was reduction of the malleolar circumference upon completion of treatment as compared with the baseline values, with the secondary outcome measures being the dynamics of parameters according to the Venous Clinical Severity Score (VCSS), CIVIQ-2 quality of life questionnaire, and the findings of ultrasonographic duplex scanning. RESULTS The obtained findings demonstrated efficacy of therapy with the use of Detravenol in treatment of patients with chronic venous insufficiency of the lower limbs. The 60-day therapy with the study drug resulted in decreased oedema of the lower extremities: the malleolar circumference reduced averagely by 4%, the composite index of the venous clinical severity score diminished averagely by 50%, and the subjective measure of quality of life increased. Patients taking the study drug demonstrated positive dynamics according to the findings of ultrasonographic duplex scanning, with no serious adverse events during the trial observed. CONCLUSION By the primary outcome measure of efficacy (reduction of the malleolar circumference) therapy using the investigational drug proved to be not inferior to therapy with the comparator drug. By the secondary outcome measures the compared therapies appeared equally effective. The study drug and the comparator were found to have a similar safety profile.",2020,"Patients taking the study drug demonstrated positive dynamics according to the findings of ultrasonographic duplex scanning, with no serious adverse events during the trial observed. ","['patients presenting with chronic venous insufficiency of the lower extremities caused by lower limb varicose veins', 'patients with chronic venous insufficiency of the lower limbs', '106 patients with chronic venous insufficiency of the lower extremities secondary to lower limb varicose veins', 'chronic venous insufficiency of lower limbs']","['Detralex®', 'Detravenol']","['efficacy (reduction of the malleolar circumference) therapy', 'Venous Clinical Severity Score (VCSS), CIVIQ-2 quality of life questionnaire, and the findings of ultrasonographic duplex scanning', 'efficacy and safety', 'malleolar circumference upon completion of treatment', 'oedema of the lower extremities: the malleolar circumference', 'efficacy', 'composite index of the venous clinical severity score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C1306557', 'cui_str': 'Venous insufficiency (chronic) (peripheral)'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0042345', 'cui_str': 'Phlebectasia'}, {'cui': 'C0175668', 'cui_str': 'Secondary'}]","[{'cui': 'C0379896', 'cui_str': 'Detralex'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0332520', 'cui_str': 'Circumference'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0042449', 'cui_str': 'Venous structure'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0457451', 'cui_str': 'Severity score'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0444916', 'cui_str': 'Duplex'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0013604', 'cui_str': 'Edema'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",106.0,0.038315,"Patients taking the study drug demonstrated positive dynamics according to the findings of ultrasonographic duplex scanning, with no serious adverse events during the trial observed. ","[{'ForeName': 'É A', 'Initials': 'ÉA', 'LastName': 'Ponomarev', 'Affiliation': 'Department of Hospital Surgery, Volgograd State Medical University, Volgograd, Russia.'}, {'ForeName': 'N N', 'Initials': 'NN', 'LastName': 'Strepetov', 'Affiliation': 'Department of Hospital Surgery, Volgograd State Medical University, Volgograd, Russia.'}, {'ForeName': 'I E', 'Initials': 'IE', 'LastName': 'Sotnikov', 'Affiliation': ""Limited Liability Company 'Expert Legal Centre', Moscow, Russia.""}, {'ForeName': 'S V', 'Initials': 'SV', 'LastName': ""Vasil'ev"", 'Affiliation': ""Limited Liability Company 'Expert Legal Centre', Moscow, Russia.""}, {'ForeName': 'V S', 'Initials': 'VS', 'LastName': 'Arnautov', 'Affiliation': ""Limited Liability Company 'Expert Legal Centre', Moscow, Russia.""}, {'ForeName': 'I S', 'Initials': 'IS', 'LastName': 'Kasatkina', 'Affiliation': ""Limited Liability Company 'Expert Legal Centre', Moscow, Russia.""}, {'ForeName': 'A V', 'Initials': 'AV', 'LastName': 'Bukhtenkov', 'Affiliation': ""Limited Liability Company 'Expert Legal Centre', Moscow, Russia.""}]",Angiologiia i sosudistaia khirurgiia = Angiology and vascular surgery,['10.33529/ANGI02020201'] 2094,32598041,In Reference to A Randomized Controlled Trial of Adjuvant Mitomycin-C in Endoscopic Surgery for Laryngotracheal Stenosis.,,2020,,['Endoscopic Surgery for Laryngotracheal Stenosis'],['Adjuvant Mitomycin-C'],[],"[{'cui': 'C0282493', 'cui_str': 'Endoscopy with surgical procedure'}, {'cui': 'C0450117', 'cui_str': 'Laryngotracheal'}, {'cui': 'C0678234', 'cui_str': 'Form of stenosis'}]","[{'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0002475', 'cui_str': 'Mitomycin'}]",[],,0.134449,,"[{'ForeName': 'Frederik G', 'Initials': 'FG', 'LastName': 'Dikkers', 'Affiliation': 'Department of Otorhinolaryngology, Academic Medical Center and Free University Medical Center, Amsterdam, the Netherlands.'}]",The Laryngoscope,['10.1002/lary.28834'] 2095,32593293,"The Promotoer, a brain-computer interface-assisted intervention to promote upper limb functional motor recovery after stroke: a study protocol for a randomized controlled trial to test early and long-term efficacy and to identify determinants of response.","BACKGROUND Stroke is a leading cause of long-term disability. Cost-effective post-stroke rehabilitation programs for upper limb are critically needed. Brain-Computer Interfaces (BCIs) which enable the modulation of Electroencephalography (EEG) sensorimotor rhythms are promising tools to promote post-stroke recovery of upper limb motor function. The ""Promotoer"" study intends to boost the application of the EEG-based BCIs in clinical practice providing evidence for a short/long-term efficacy in enhancing post-stroke hand functional motor recovery and quantifiable indices of the participants response to a BCI-based intervention. To these aims, a longitudinal study will be performed in which subacute stroke participants will undergo a hand motor imagery (MI) training assisted by the Promotoer system, an EEG-based BCI system fully compliant with rehabilitation requirements. METHODS This longitudinal 2-arm randomized controlled superiority trial will include 48 first ever, unilateral, subacute stroke participants, randomly assigned to 2 intervention groups: the BCI-assisted hand MI training and a hand MI training not supported by BCI. Both interventions are delivered (3 weekly session; 6 weeks) as add-on regimen to standard intensive rehabilitation. A multidimensional assessment will be performed at: randomization/pre-intervention, 48 h post-intervention, and at 1, 3 and 6 month/s after end of intervention. Primary outcome measure is the Fugl-Meyer Assessment (FMA, upper extremity) at 48 h post-intervention. Secondary outcome measures include: the upper extremity FMA at follow-up, the Modified Ashworth Scale, the Numeric Rating Scale for pain, the Action Research Arm Test, the National Institute of Health Stroke Scale, the Manual Muscle Test, all collected at the different timepoints as well as neurophysiological and neuroimaging measures. DISCUSSION We expect the BCI-based rewarding of hand MI practice to promote long-lasting retention of the early induced improvement in hand motor outcome and also, this clinical improvement to be sustained by a long-lasting neuroplasticity changes harnessed by the BCI-based intervention. Furthermore, the longitudinal multidimensional assessment will address the selection of those stroke participants who best benefit of a BCI-assisted therapy, consistently advancing the transfer of BCIs to a best clinical practice. TRIAL REGISTRATION Name of registry: BCI-assisted MI Intervention in Subacute Stroke (Promotoer). TRIAL REGISTRATION NUMBER NCT04353297 ; registration date on the ClinicalTrial.gov platform: April, 15/2020.",2020,"Primary outcome measure is the Fugl-Meyer Assessment (FMA, upper extremity) at 48 h post-intervention.","['48 first ever, unilateral, subacute stroke participants', 'subacute stroke participants']","['hand motor imagery (MI) training assisted by the Promotoer system, an EEG-based BCI system fully compliant with rehabilitation requirements', 'Brain-Computer Interfaces (BCIs', 'BCI-assisted MI Intervention', 'BCI-assisted hand MI training and a hand MI training not supported by BCI']","['Fugl-Meyer Assessment (FMA, upper extremity', ' the upper extremity FMA at follow-up, the Modified Ashworth Scale, the Numeric Rating Scale for pain, the Action Research Arm Test, the National Institute of Health Stroke Scale, the Manual Muscle Test, all collected at the different timepoints as well as neurophysiological and neuroimaging measures']","[{'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0205365', 'cui_str': 'Subacute'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}]","[{'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0150627', 'cui_str': 'Simple guided imagery'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C2742590', 'cui_str': '2-benzylidene-3-(cyclohexylamino)-2,3-dihydro-1H-inden-1-one'}, {'cui': 'C0566588', 'cui_str': 'Compliant'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C3494288', 'cui_str': 'Brain-Computer Interface'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0183683', 'cui_str': 'Support'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C4707572', 'cui_str': 'Modified Ashworth Scale'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C4720875', 'cui_str': 'Action research arm test'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0451362', 'cui_str': 'Oxford grading scale for muscle strength'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",48.0,0.0693517,"Primary outcome measure is the Fugl-Meyer Assessment (FMA, upper extremity) at 48 h post-intervention.","[{'ForeName': 'Donatella', 'Initials': 'D', 'LastName': 'Mattia', 'Affiliation': 'Fondazione Santa Lucia, IRCCS, Rome, Italy. d.mattia@hsantalucia.it.'}, {'ForeName': 'Floriana', 'Initials': 'F', 'LastName': 'Pichiorri', 'Affiliation': 'Fondazione Santa Lucia, IRCCS, Rome, Italy.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Colamarino', 'Affiliation': 'Fondazione Santa Lucia, IRCCS, Rome, Italy.'}, {'ForeName': 'Marcella', 'Initials': 'M', 'LastName': 'Masciullo', 'Affiliation': 'Fondazione Santa Lucia, IRCCS, Rome, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Morone', 'Affiliation': 'Fondazione Santa Lucia, IRCCS, Rome, Italy.'}, {'ForeName': 'Jlenia', 'Initials': 'J', 'LastName': 'Toppi', 'Affiliation': 'Fondazione Santa Lucia, IRCCS, Rome, Italy.'}, {'ForeName': 'Iolanda', 'Initials': 'I', 'LastName': 'Pisotta', 'Affiliation': 'Fondazione Santa Lucia, IRCCS, Rome, Italy.'}, {'ForeName': 'Federica', 'Initials': 'F', 'LastName': 'Tamburella', 'Affiliation': 'Fondazione Santa Lucia, IRCCS, Rome, Italy.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Lorusso', 'Affiliation': 'Fondazione Santa Lucia, IRCCS, Rome, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Paolucci', 'Affiliation': 'Fondazione Santa Lucia, IRCCS, Rome, Italy.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Puopolo', 'Affiliation': 'Istituto Superiore di Sanità, Rome, Italy.'}, {'ForeName': 'Febo', 'Initials': 'F', 'LastName': 'Cincotti', 'Affiliation': 'Fondazione Santa Lucia, IRCCS, Rome, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Molinari', 'Affiliation': 'Fondazione Santa Lucia, IRCCS, Rome, Italy.'}]",BMC neurology,['10.1186/s12883-020-01826-w'] 2096,32593323,"Self-expanding intra-annular versus commercially available transcatheter heart valves in high and extreme risk patients with severe aortic stenosis (PORTICO IDE): a randomised, controlled, non-inferiority trial.","BACKGROUND Randomised trial data assessing the safety and efficacy of the self-expanding intra-annular Portico transcatheter aortic valve system (Abbott Structural Heart, St Paul, MN, USA) compared with any commercially available valves are needed to compare performance among designs. METHODS In this prospective, multicentre, non-inferiority, randomised controlled trial (the Portico Re-sheathable Transcatheter Aortic Valve System US Investigational Device Exemption trial [PORTICO IDE]), high and extreme risk patients with severe symptomatic aortic stenosis were recruited from 52 medical centres experienced in performing transcatheter aortic valve replacement in the USA and Australia. Patients were eligible if they were aged 21 years or older, in New York Heart Association functional class II or higher, and had severe native aortic stenosis. Eligible patients were randomly assigned (1:1) using permuted block randomisation (block sizes of 2 and 4) and stratified by clinical investigational site, surgical risk cohort, and vascular access method, to transcatheter aortic valve replacement with the first generation Portico valve and delivery system or a commercially available valve (either an intra-annular balloon-expandable Edwards-SAPIEN, SAPIEN XT, or SAPIEN 3 valve [Edwards LifeSciences, Irvine, CA, USA]; or a supra-annular self-expanding CoreValve, Evolut-R, or Evolut-PRO valve [Medtronic, Minneapolis, MN, USA]). Investigational site staff, implanting physician, and study participant were unmasked to treatment assignment. Core laboratories and clinical event assessors were masked to treatment allocation. The primary safety endpoint was a composite of all-cause mortality, disabling stroke, life-threatening bleeding requiring transfusion, acute kidney injury requiring dialysis, or major vascular complication at 30 days. The primary efficacy endpoint was all-cause mortality or disabling stroke at 1 year. Clinical outcomes and valve performance were assessed up to 2 years after the procedure. Primary analyses were by intention to treat and the Kaplan-Meier method to estimate event rates. The non-inferiority margin was 8·5% for primary safety and 8·0% for primary efficacy endpoints. This study is registered with ClinicalTrials.gov, NCT02000115, and is ongoing. FINDINGS Between May 30 and Sept 12, 2014, and between Aug 21, 2015, and Oct 10, 2017, with recruitment paused for 11 months by the funder, we recruited 1034 patients, of whom 750 were eligible and randomly assigned to the Portico valve group (n=381) or commercially available valve group (n=369). Mean age was 83 years (SD 7) and 395 (52·7%) patients were female. For the primary safety endpoint at 30 days, the event rate was higher in the Portico valve group than in the commercial valve group (52 [13·8%] vs 35 [9·6%]; absolute difference 4·2, 95% CI -0·4 to 8·8 [upper confidence bound {UCB} 8·1%]; p non-inferiority =0·034, p superiority =0·071). At 1 year, the rates of the primary efficacy endpoint were similar between the groups (55 [14·8%] in the Portico group vs 48 [13·4%] in the commercial valve group; difference 1·5%, 95% CI -3·6 to 6·5 [UCB 5·7%]; p non-inferiority =0·0058, p superiority =0·50). At 2 years, rates of death (80 [22·3%] vs 70 [20·2%]; p=0·40) or disabling stroke (10 [3·1%] vs 16 [5·0%]; p=0·23) were similar between groups. INTERPRETATION The Portico valve was associated with similar rates of death or disabling stroke at 2 years compared with commercial valves, but was associated with higher rates of the primary composite safety endpoint including death at 30 days. The first-generation Portico valve and delivery system did not offer advantages over other commercially available valves. FUNDING Abbott.",2020,"The Portico valve was associated with similar rates of death or disabling stroke at 2 years compared with commercial valves, but was associated with higher rates of the primary composite safety endpoint including death at 30 days.","['high and extreme risk patients with severe aortic stenosis (PORTICO IDE', '1034 patients, of whom 750 were eligible and randomly assigned to the Portico valve group (n=381) or commercially available valve group (n=369', 'risk patients with severe symptomatic aortic stenosis were recruited from 52 medical centres experienced in performing transcatheter aortic valve replacement in the USA and Australia', 'Mean age was 83 years (SD 7) and 395 (52·7%) patients were female', 'Patients were eligible if they were aged 21 years or older, in New York Heart Association functional class II or higher, and had severe native aortic stenosis', 'Eligible patients']","['self-expanding intra-annular Portico transcatheter aortic valve system (Abbott Structural Heart, St Paul, MN, USA', 'transcatheter aortic valve replacement with the first generation Portico valve and delivery system or a commercially available valve (either an intra-annular balloon-expandable Edwards-SAPIEN, SAPIEN XT', 'Self-expanding intra-annular versus commercially available transcatheter heart valves']","['event rate', 'intention to treat and the Kaplan-Meier method to estimate event rates', 'cause mortality or disabling stroke', 'disabling stroke', 'composite of all-cause mortality, disabling stroke, life-threatening bleeding requiring transfusion, acute kidney injury requiring dialysis, or major vascular complication at 30 days', 'safety and efficacy', 'rates of death', 'Clinical outcomes and valve performance', 'rates of death or disabling stroke', 'rates of the primary efficacy endpoint']","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205403', 'cui_str': 'Extreme'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0003507', 'cui_str': 'Aortic valve stenosis'}, {'cui': 'C0328104', 'cui_str': 'Leuciscus idus'}, {'cui': 'C4517868', 'cui_str': '750'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0018826', 'cui_str': 'Cardiac valve structure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C2711836', 'cui_str': 'Percutaneous replacement of aortic valve using fluoroscopic guidance'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0441886', 'cui_str': 'Class 2'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0079891', 'cui_str': 'Indigenous Population'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0205229', 'cui_str': 'Expanding'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0521164', 'cui_str': 'Annular shape'}, {'cui': 'C0442343', 'cui_str': 'Transcatheter approach'}, {'cui': 'C0003501', 'cui_str': 'Aortic valve structure'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C2711836', 'cui_str': 'Percutaneous replacement of aortic valve using fluoroscopic guidance'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C0018826', 'cui_str': 'Cardiac valve structure'}, {'cui': 'C0449914', 'cui_str': 'Delivery system'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft'}, {'cui': 'C0018825', 'cui_str': 'Cardiac valve prosthesis'}]","[{'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C3537125', 'cui_str': 'Common terminology criteria for adverse events grade 4'}, {'cui': 'C4302018', 'cui_str': 'Bleeding requiring transfusion'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C0011945', 'cui_str': 'Dialysis'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0018826', 'cui_str': 'Cardiac valve structure'}, {'cui': 'C0205225', 'cui_str': 'Principal'}]",,0.297403,"The Portico valve was associated with similar rates of death or disabling stroke at 2 years compared with commercial valves, but was associated with higher rates of the primary composite safety endpoint including death at 30 days.","[{'ForeName': 'Raj R', 'Initials': 'RR', 'LastName': 'Makkar', 'Affiliation': 'Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles, CA, USA. Electronic address: raj.makkar@cshs.org.'}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Cheng', 'Affiliation': 'Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles, CA, USA.'}, {'ForeName': 'Ron', 'Initials': 'R', 'LastName': 'Waksman', 'Affiliation': 'Washington Hospital Center, Washington, DC, USA.'}, {'ForeName': 'Lowell F', 'Initials': 'LF', 'LastName': 'Satler', 'Affiliation': 'Washington Hospital Center, Washington, DC, USA.'}, {'ForeName': 'Tarun', 'Initials': 'T', 'LastName': 'Chakravarty', 'Affiliation': 'Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles, CA, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Groh', 'Affiliation': 'Mission Health and Hospitals, Asheville, NC, USA.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Abernethy', 'Affiliation': 'Mission Health and Hospitals, Asheville, NC, USA.'}, {'ForeName': 'Mark J', 'Initials': 'MJ', 'LastName': 'Russo', 'Affiliation': 'Rutgers-Robert Wood Johnson Medical School, New Brunswick, NJ, USA; Newark Beth Israel Medical Center, Newark, NY, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Heimansohn', 'Affiliation': 'St Vincent Heart Center, Indianapolis, IN, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Hermiller', 'Affiliation': 'St Vincent Heart Center, Indianapolis, IN, USA.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Worthley', 'Affiliation': 'Royal Adelaide Hospital, Adelaide, SA, Australia; Genesis Care, Sydney, NSW, Australia.'}, {'ForeName': 'Bassem', 'Initials': 'B', 'LastName': 'Chehab', 'Affiliation': 'Cardiovascular Research Institute of Kansas, Ascension Via Christi Hospital, Wichita, KS, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Cunningham', 'Affiliation': 'University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Ray', 'Initials': 'R', 'LastName': 'Matthews', 'Affiliation': 'University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Ravi K', 'Initials': 'RK', 'LastName': 'Ramana', 'Affiliation': 'Advocate Christ Medical Center, Oak Lawn, IL, USA; Heart Care Centers of Illinois, Palos Park, IL, USA.'}, {'ForeName': 'Gerald', 'Initials': 'G', 'LastName': 'Yong', 'Affiliation': 'Fiona Stanley Hospital, Murdoch, WA, Australia.'}, {'ForeName': 'Carlos E', 'Initials': 'CE', 'LastName': 'Ruiz', 'Affiliation': 'Hackensack University Medical Center, Hackensack, NJ, USA.'}, {'ForeName': 'Chunguang', 'Initials': 'C', 'LastName': 'Chen', 'Affiliation': 'Newark Beth Israel Medical Center, Newark, NY, USA.'}, {'ForeName': 'Federico M', 'Initials': 'FM', 'LastName': 'Asch', 'Affiliation': 'MedStar Health Research Institute, Washington, DC, USA.'}, {'ForeName': 'Mamoo', 'Initials': 'M', 'LastName': 'Nakamura', 'Affiliation': 'Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles, CA, USA.'}, {'ForeName': 'Hasan', 'Initials': 'H', 'LastName': 'Jilaihawi', 'Affiliation': 'NYU Langone Health, New York, NY, USA.'}, {'ForeName': 'Rahul', 'Initials': 'R', 'LastName': 'Sharma', 'Affiliation': 'Stanford University Medical Center, Stanford, CA, USA.'}, {'ForeName': 'Sung-Han', 'Initials': 'SH', 'LastName': 'Yoon', 'Affiliation': 'Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles, CA, USA.'}, {'ForeName': 'Augusto D', 'Initials': 'AD', 'LastName': 'Pichard', 'Affiliation': 'Abbott, Abbott Park, IL, USA.'}, {'ForeName': 'Samir', 'Initials': 'S', 'LastName': 'Kapadia', 'Affiliation': 'Cleveland Clinic, Cleveland, OH, USA.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Reardon', 'Affiliation': 'Houston Methodist Hospital, Houston, TX, USA.'}, {'ForeName': 'Deepak L', 'Initials': 'DL', 'LastName': 'Bhatt', 'Affiliation': ""Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Gregory P', 'Initials': 'GP', 'LastName': 'Fontana', 'Affiliation': 'Cardiovascular Institute, Los Robles Regional Medical Center, Thousand Oaks, CA, USA.'}]","Lancet (London, England)",['10.1016/S0140-6736(20)31358-1'] 2097,32593487,Highly Porous Tantalum Acetabular Components Without Ancillary Screws Have Similar Migration to Porous Titanium Acetabular Components With Screws at 2 Years: A Randomized Controlled Trial.,"BACKGROUND It is proposed that highly porous coatings on acetabular components, such as a porous tantalum coating, provide adequate fixation without ancillary screw fixation in primary total hip arthroplasty (THA). However, tantalum acetabular components have been associated with higher rates of revision than other uncemented components in national registries. The aim of this randomized controlled trial is to determine whether the early migration of a solid-backed tantalum acetabular component was no greater than that of a titanium acetabular component with ancillary screw fixation that has proven good clinical results. METHODS Sixty-six patients aged 40 to 64 years, with osteoarthritis and Charnley grade A or B activity grade and who underwent primary THA, were recruited into the trial. Patients were randomized intraoperatively to receive either the tantalum or titanium acetabular component. All patients received the same cemented polished tapered femoral stem, 28-mm cobalt-chromium femoral head, and highly cross-linked polyethylene liner. Acetabular component migration was measured using radiostereometric analysis at 4-6 days postoperatively and at 6 weeks, 3 months, 1 and 2 years following THA. RESULTS The mean proximal migration at 2 years for the tantalum cohort was 0.17 mm (95% confidence interval, 0.09-0.24) which was no greater than that of the titanium cohort which was 0.19 mm (0.07-0.32). Harris hip scores and functional activity scores were similar between groups. CONCLUSION These results demonstrate that early stability can be achieved without ancillary screw fixation through the use of a highly porous high friction coating on a solid-backed modular acetabular component. LEVEL OF EVIDENCE Level I.",2020,"Harris hip scores and functional activity scores were similar between groups. ","['Sixty-six patients aged 40 to 64 years, with osteoarthritis and Charnley grade A or B activity grade and who underwent primary THA, were recruited into the trial']","['same cemented polished tapered femoral stem, 28-mm cobalt-chromium femoral head, and highly cross-linked polyethylene liner', 'Highly Porous Tantalum Acetabular Components', 'titanium acetabular component with ancillary screw fixation', 'tantalum or titanium acetabular component']","['Harris hip scores and functional activity scores', 'Acetabular component migration', 'mean proximal migration']","[{'cui': 'C4517841', 'cui_str': '66'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0309195', 'cui_str': 'Grade A'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0011343', 'cui_str': 'Cementum structure'}, {'cui': 'C0441640', 'cui_str': 'Tapering - action'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}, {'cui': 'C0162731', 'cui_str': 'STEM'}, {'cui': 'C0009148', 'cui_str': 'Cobalt'}, {'cui': 'C0008574', 'cui_str': 'Chromium'}, {'cui': 'C0015813', 'cui_str': 'Structure of head of femur'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0332220', 'cui_str': 'Cross-linking'}, {'cui': 'C0032487', 'cui_str': 'Polyethylenes'}, {'cui': 'C0181663', 'cui_str': 'Liner'}, {'cui': 'C0039297', 'cui_str': 'Tantalum'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0040302', 'cui_str': 'Titanium'}, {'cui': 'C0005975', 'cui_str': 'Bone screw'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}]","[{'cui': 'C2919875', 'cui_str': 'Harris hip score'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0237731', 'cui_str': 'Human Migration'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205107', 'cui_str': 'Proximal'}]",66.0,0.276053,"Harris hip scores and functional activity scores were similar between groups. ","[{'ForeName': 'Donald W', 'Initials': 'DW', 'LastName': 'Howie', 'Affiliation': 'Department of Orthopaedics and Trauma, Royal Adelaide Hospital, Adelaide, South Australia, Australia; Centre for Orthopaedic and Trauma Research, The University of Adelaide, Adelaide, South Australia, Australia.'}, {'ForeName': 'Oksana T', 'Initials': 'OT', 'LastName': 'Holubowycz', 'Affiliation': 'Centre for Orthopaedic and Trauma Research, The University of Adelaide, Adelaide, South Australia, Australia.'}, {'ForeName': 'Stuart A', 'Initials': 'SA', 'LastName': 'Callary', 'Affiliation': 'Department of Orthopaedics and Trauma, Royal Adelaide Hospital, Adelaide, South Australia, Australia; Centre for Orthopaedic and Trauma Research, The University of Adelaide, Adelaide, South Australia, Australia.'}, {'ForeName': 'Thomas S', 'Initials': 'TS', 'LastName': 'Robertson', 'Affiliation': 'Centre for Orthopaedic and Trauma Research, The University of Adelaide, Adelaide, South Australia, Australia.'}, {'ForeName': 'Lucian B', 'Initials': 'LB', 'LastName': 'Solomon', 'Affiliation': 'Department of Orthopaedics and Trauma, Royal Adelaide Hospital, Adelaide, South Australia, Australia; Centre for Orthopaedic and Trauma Research, The University of Adelaide, Adelaide, South Australia, Australia.'}]",The Journal of arthroplasty,['10.1016/j.arth.2020.05.049'] 2098,32593489,Fidelity and sustainability of Mouth Care Without a Battle and lessons for other innovations in care.,"There are countless efficacious interventions that improve outcomes when conducted in controlled situations. Many fewer are effective when implemented in real-world situations, largely because they are not implemented with fidelity. Still fewer are sustained over time, for reasons including lack of institutional support and fit with existing values, among others. It is especially important to examine fidelity and sustainability when efficacious interventions are being implemented, because these interventions are the ones that hold the most promise. This project examined the fidelity and sustainability of Mouth Care Without a Battle (MCWB), an evidence-based program conducted in a two-year cluster randomized trial in 14 nursing homes. Results that triangulated two sources of data indicated that fidelity decreased after the first year; they provide guidance to promote fidelity and sustainability of this and other new care practices in nursing homes, including ongoing education, coaching, evaluation, feedback, and sufficient resources.",2020,"This project examined the fidelity and sustainability of Mouth Care Without a Battle (MCWB), an evidence-based program conducted in a two-year cluster randomized trial in 14 nursing homes.",['14 nursing homes'],['Mouth Care Without a Battle (MCWB'],['Fidelity and sustainability of mouth care'],"[{'cui': 'C0028688', 'cui_str': 'Long term care facility'}]","[{'cui': 'C1272386', 'cui_str': 'Mouth care management'}]","[{'cui': 'C1272386', 'cui_str': 'Mouth care management'}]",14.0,0.0401182,"This project examined the fidelity and sustainability of Mouth Care Without a Battle (MCWB), an evidence-based program conducted in a two-year cluster randomized trial in 14 nursing homes.","[{'ForeName': 'Sheryl', 'Initials': 'S', 'LastName': 'Zimmerman', 'Affiliation': 'The Cecil G. Sheps Center for Health Services Research, University of North Carolina at Chapel Hill; School of Social Work, University of North Carolina at Chapel Hill; Gillings School of Global Public Health, University of North Carolina at Chapel Hill. Electronic address: Sheryl_Zimmerman@unc.edu.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Wretman', 'Affiliation': 'The Cecil G. Sheps Center for Health Services Research, University of North Carolina at Chapel Hill; School of Social Work, University of North Carolina at Chapel Hill.'}, {'ForeName': 'Kimberly', 'Initials': 'K', 'LastName': 'Ward', 'Affiliation': 'The Cecil G. Sheps Center for Health Services Research, University of North Carolina at Chapel Hill.'}, {'ForeName': 'Meera', 'Initials': 'M', 'LastName': 'Tandan', 'Affiliation': 'The Cecil G. Sheps Center for Health Services Research, University of North Carolina at Chapel Hill.'}, {'ForeName': 'Philip D', 'Initials': 'PD', 'LastName': 'Sloane', 'Affiliation': 'The Cecil G. Sheps Center for Health Services Research, University of North Carolina at Chapel Hill; Department of Family Medicine, School of Medicine, University of North Carolina at Chapel Hill.'}, {'ForeName': 'John S', 'Initials': 'JS', 'LastName': 'Preisser', 'Affiliation': 'Gillings School of Global Public Health, University of North Carolina at Chapel Hill.'}]","Geriatric nursing (New York, N.Y.)",['10.1016/j.gerinurse.2020.06.002'] 2099,32593524,Ursolic acid has no additional effect on muscle strength and mass in active men undergoing a high-protein diet and resistance training: A double-blind and placebo-controlled trial.,"BACKGROUND Ursolic acid (UA) is thought to have an anabolic effect on muscle mass in humans. This study sought to compare the effects of UA and a placebo on muscle strength and mass in young men undergoing resistance training (RT) and consuming a high-protein diet. METHODS A clinical, double-blind, placebo-controlled trial was conducted for 8 weeks. The Control + RT group (CON n = 12) received 400 mg/d of placebo, and the UA + RT group (UA n = 10) received 400 mg/d of UA. Both groups ingested ~1.6 g/kg of protein and performed the same RT program. Pre- and post-intervention, both groups were evaluated for anthropometric measures, body composition, food intake and muscle strength. RESULTS Food intake remained unchanged throughout the study. Both groups showed significant increases in body weight (CON Δ: 2.12 ± 0.47 kg, p = 0.001 vs. UA Δ: 2.24 ± 0.67 kg, p = 0.009), body mass index (BMI) (CON Δ: 0.69 ± 0.15 kg/m 2 , p = 0.001 vs. UA Δ: 0.75 ± 0.23, p = 0.011) and thigh circumference (CON Δ: 1.50 ± 0.36, p = 0.002 vs. UA Δ: 2.46 ± 0.50 cm, p = 0.003 vs. UA 1.84 ± 0.82 cm, p = 0.001), with differences between them. There was no difference in the arm, waist and hip circumferences. Both groups showed increases in muscle mass (CON Δ: 1.12 ± 0.26, p = 0.001 vs. UA Δ: 1.08 ± 0.28 kg, p = 0.004), but there was no significant difference between them. Additionally, there were significant increases in the one repetition maximum test in the bench press and in the 10-repetition maximum test in the knee extension (CON Δ: 5.00 ± 2.09, p = 0.036 vs. UA Δ: 7.8 ± 1.87, p = 0.340 and CON Δ: 3.58 ± 1.15, p = 0.010 vs. UA Δ: 1.20 ± 0.72, p = 0.133), respectively, with no difference between them. CONCLUSIONS Ursolic acid had no synergic effect on muscle strength and mass in response to RT in physically active men consuming a high-protein diet. BRAZILIAN CLINICAL TRIALS REGISTRY (REBEC) RBR-76tbqs.",2020,"Additionally, there were significant increases in the one repetition maximum test in the bench press and in the 10-repetition maximum test in the knee extension (CON Δ: 5.00 ± 2.09, p = ","['young men undergoing resistance training (RT) and consuming a high-protein diet', 'active men undergoing a high-protein diet and resistance training']","['UA and a placebo', 'placebo, and the UA\xa0+\xa0RT group (UA n\xa0=\xa010) received 400\xa0mg/d of UA', 'Pre- and post-intervention', 'Ursolic acid', 'placebo']","['thigh circumference', 'body weight', 'muscle mass', 'anthropometric measures, body composition, food intake and muscle strength', 'muscle strength and mass in response to RT', 'muscle strength and mass', 'waist and hip circumferences', 'one repetition maximum test', 'body mass index (BMI']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0425403', 'cui_str': 'Increased protein diet'}, {'cui': 'C0205177', 'cui_str': 'Active'}]","[{'cui': 'C0077938', 'cui_str': 'ursolic acid'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0039866', 'cui_str': 'Thigh structure'}, {'cui': 'C0332520', 'cui_str': 'Circumference'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0240417', 'cui_str': 'Form of muscle'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0013470', 'cui_str': 'Eating'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0230097', 'cui_str': 'Structure of waist (surface region)'}, {'cui': 'C0562350', 'cui_str': 'Hip circumference'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]",,0.26676,"Additionally, there were significant increases in the one repetition maximum test in the bench press and in the 10-repetition maximum test in the knee extension (CON Δ: 5.00 ± 2.09, p = ","[{'ForeName': 'Patrícia C B', 'Initials': 'PCB', 'LastName': 'Lobo', 'Affiliation': 'Clinical and Sports Nutrition Research Laboratory (Labince), Faculty of Nutrition, Federal University of Goias, Goiânia, Brazil.'}, {'ForeName': 'Itamar P', 'Initials': 'IP', 'LastName': 'Vieira', 'Affiliation': 'Faculty of Physical Education and Dance, Federal University of Goias, Goiânia, Brazil.'}, {'ForeName': 'Claude', 'Initials': 'C', 'LastName': 'Pichard', 'Affiliation': 'Clinical Nutrition, Geneva University Hospital, Geneva, Switzerland.'}, {'ForeName': 'Bruna S', 'Initials': 'BS', 'LastName': 'Marques', 'Affiliation': 'Department of Clinical Analyses, Health Sciences Center, Federal University of Santa Catarina, Florianópolis, Santa Catarina, Brazil.'}, {'ForeName': 'Paulo', 'Initials': 'P', 'LastName': 'Gentil', 'Affiliation': 'Faculty of Physical Education and Dance, Federal University of Goias, Goiânia, Brazil.'}, {'ForeName': 'Edson L', 'Initials': 'EL', 'LastName': 'da Silva', 'Affiliation': 'Department of Clinical Analyses, Health Sciences Center, Federal University of Santa Catarina, Florianópolis, Santa Catarina, Brazil; Post-Graduation Program in Nutrition, Health Sciences Center, Federal University of Santa Catarina, Florianópolis, Santa Catarina, Brazil.'}, {'ForeName': 'Gustavo D', 'Initials': 'GD', 'LastName': 'Pimentel', 'Affiliation': 'Clinical and Sports Nutrition Research Laboratory (Labince), Faculty of Nutrition, Federal University of Goias, Goiânia, Brazil. Electronic address: gupimentel@yahoo.com.br.'}]","Clinical nutrition (Edinburgh, Scotland)",['10.1016/j.clnu.2020.06.004'] 2100,32593547,Pegvaliase for the treatment of phenylketonuria: Results of the phase 2 dose-finding studies with long-term follow-up.,"BACKGROUND Phenylketonuria (PKU) is characterized by a deficiency in phenylalanine hydroxylase (PAH) that may lead to elevated blood phenylalanine (Phe) and significant neurocognitive and neuropsychological comorbidities. Pegvaliase (PALYNZIQ®, BioMarin Pharmaceutical Inc.) is a PEGylated recombinant Anabaena variabilis phenylalanine ammonia lyase (PAL), which converts Phe to trans-cinnamic acid and ammonia, and was approved in May 2018 in the United States and in May 2019 in the European Union for decreasing blood Phe levels in adults with PKU with blood Phe levels >600 μmol/L. The efficacy and safety of pegvaliase was assessed in two phase 2 dose-finding studies in adults with PKU (PAL-002, NCT00925054, and PAL-004, NCT01212744). Participants completing these studies could enroll in a long-term extension study (PAL-003, NCT00924703). METHODS Participants in PAL-002 received pegvaliase 0.001, 0.003, 0.01, 0.03, or 0.1 mg/kg weekly for 8 weeks, then continued treatment for a further 8 weeks with dose and/or frequency adjusted to achieve blood Phe concentrations of 60 to 600 μmol/L. Participants in PAL-004 received pegvaliase 0.001 to 0.4 mg/kg 5 days/week for 13 weeks, with modifications made to the starting dose in response to safety and/or efficacy, followed by 3 additional weeks of follow-up assessments. The maximum allowable daily dose in both studies was 1.0 mg/kg/day (5.0 mg/kg/week). Participants who completed any of the phase 2 studies (PAL-002; PAL-004; or a third phase 2 study, 165-205) were eligible to enroll in an open-label, multicenter, long-term extension study (PAL-003, NCT00924703). RESULTS Thirty-seven of the 40 enrolled participants completed PAL-002 and 15 of the 16 enrolled participants completed PAL-004. Mean blood Phe at baseline was 1311.0 (standard deviation [SD] 354) μmol/L in PAL-002 and 1482.1 (SD 363.5) μmol/L in PAL-004. Mean blood Phe did not substantially decrease with pegvaliase treatment in PAL-002 (-206.3 [SD 287.1] μmol/L at Week 16) or PAL-004 (-410.8 [SD 653.7] μmol/L at Week 13). In PAL-004, mean blood Phe dropped from baseline by 929.1 μmol/L (SD 691.1) by Week 2; subsequent to dose modifications and interruptions, this early decrease in mean Phe level was not sustained. With increased pegvaliase dose and duration in PAL-003, mean blood Phe levels steadily decreased from baseline, with mean reductions by Week 120 of 68.8% (SD 44.2%) in PAL-002 participants and 75.9% (SD 32.4%) in PAL-004 participants. All participants in PAL-002 and PAL-004 reported ≥1 adverse event (AE), with higher exposure-adjusted event rates in PAL-004. The majority of AEs were mild (87.2% in PAL-002, 86.7% in PAL-004) or moderate (12.4% in PAL-002, 13.3% in PAL-004). The most commonly reported AEs in PAL-002 were injection site reaction (50.0% of participants), headache (42.1%), injection site erythema (36.8%), nausea (34.2%), and arthralgia (29.0%), and in PAL-004 were arthralgia (75.0%), headache (62.5%), dizziness (56.3%), injection site erythema (56.3%), and injection site reaction (50.0%). CONCLUSIONS In two phase 2 dose-finding studies, pegvaliase did not lead to substantial blood Phe reductions. Higher and more frequent pegvaliase dosing in PAL-004 led to a substantial initial drop in blood Phe, but an increase in the number of hypersensitivity AEs and dose reductions or interruptions. With increased dose and duration of treatment in PAL-003, mean blood Phe reduction was substantial and sustained, and the frequency of hypersensitivity AEs decreased and stabilized. Together, these studies led to the development of an induction-titration-maintenance regimen that has been approved for pegvaliase, with patients starting at a low weekly dose that gradually increases in dose and frequency until they achieve a standard non-weight-based daily maintenance dose. This regimen has been tested in a third phase 2 study, as well as in two successful phase 3 studies of pegvaliase.",2020,Mean blood Phe did not substantially decrease with pegvaliase treatment in PAL-002 (-206.3 [SD 287.1] μmol/L at Week 16) or PAL-004 (-410.8 [SD 653.7] μmol/L at Week 13).,"['Thirty-seven of the 40 enrolled participants completed PAL-002 and 15 of the 16 enrolled participants completed', 'adults with PKU with blood Phe levels', 'Participants who completed any of the phase 2 studies (PAL-002; PAL-004; or a third phase 2 study, 165-205) were eligible to enroll in an open-label, multicenter, long-term extension study (PAL-003, NCT00924703']",['PAL-004'],"['headache', 'dizziness', 'efficacy and safety of pegvaliase', 'frequency of hypersensitivity AEs', 'mean blood Phe', 'injection site reaction', 'pegvaliase dose and duration in PAL-003, mean blood Phe levels', 'nausea', 'arthralgia', 'injection site erythema', 'adverse event (AE', 'Mean blood Phe']","[{'cui': 'C4319569', 'cui_str': '37'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0031454', 'cui_str': 'Phenylalanine ammonia-lyase'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0031485', 'cui_str': 'Phenylketonuria'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0428204', 'cui_str': 'Phenylalanine level - finding'}, {'cui': 'C0282460', 'cui_str': 'Clinical Trials, Phase II as Topic'}, {'cui': 'C4319555', 'cui_str': '165'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0031454', 'cui_str': 'Phenylalanine ammonia-lyase'}]","[{'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C4519229', 'cui_str': 'pegvaliase'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0031453', 'cui_str': 'Phenylalanine'}, {'cui': 'C0151735', 'cui_str': 'Injection site reaction'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0031454', 'cui_str': 'Phenylalanine ammonia-lyase'}, {'cui': 'C0428204', 'cui_str': 'Phenylalanine level - finding'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0003862', 'cui_str': 'Joint pain'}, {'cui': 'C0852625', 'cui_str': 'Injection site erythema'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",40.0,0.118836,Mean blood Phe did not substantially decrease with pegvaliase treatment in PAL-002 (-206.3 [SD 287.1] μmol/L at Week 16) or PAL-004 (-410.8 [SD 653.7] μmol/L at Week 13).,"[{'ForeName': 'Barbara K', 'Initials': 'BK', 'LastName': 'Burton', 'Affiliation': ""Department of Pediatrics, Division of Genetics, Birth Defects & Metabolism, Ann & Robert H. Lurie Children's Hospital of Chicago, 225 E Chicago Ave, Chicago, IL 60611, United States of America. Electronic address: BBurton@luriechildrens.org.""}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Longo', 'Affiliation': 'Department of Pediatrics, Division of Medical Genetics, University of Utah, 295 Chipeta Way, Salt Lake City, UT 84108, United States of America. Electronic address: Nicola.Longo@hsc.utah.edu.'}, {'ForeName': 'Jerry', 'Initials': 'J', 'LastName': 'Vockley', 'Affiliation': ""Department of Pediatrics, Division of Medical Genetics, University of Pittsburgh and Children's Hospital of Pittsburgh, 4401 Penn Ave, Pittsburgh, PA 15224, United States of America. Electronic address: vockleyg@upmc.edu.""}, {'ForeName': 'Dorothy K', 'Initials': 'DK', 'LastName': 'Grange', 'Affiliation': 'Department of Pediatrics, Division of Genetics and Genomic Medicine, Washington University, 660 S Euclid Ave, St. Louis, MO 63110, United States of America. Electronic address: grangedk@wustl.edu.'}, {'ForeName': 'Cary O', 'Initials': 'CO', 'LastName': 'Harding', 'Affiliation': 'Department of Molecular and Medical Genetics, Oregon Health & Science University, Portland, OR 97239, United States of America. Electronic address: hardingc@ohsu.edu.'}, {'ForeName': 'Celeste', 'Initials': 'C', 'LastName': 'Decker', 'Affiliation': 'Research and Development, BioMarin Pharmaceutical Inc., 105 Digital Dr, Novato, CA 94949, United States of America.'}, {'ForeName': 'Mingjin', 'Initials': 'M', 'LastName': 'Li', 'Affiliation': 'Research and Development, BioMarin Pharmaceutical Inc., 105 Digital Dr, Novato, CA 94949, United States of America. Electronic address: mili@bmrn.com.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Lau', 'Affiliation': 'Research and Development, BioMarin Pharmaceutical Inc., 105 Digital Dr, Novato, CA 94949, United States of America. Electronic address: klau@bmrn.com.'}, {'ForeName': 'Orli', 'Initials': 'O', 'LastName': 'Rosen', 'Affiliation': 'Research and Development, BioMarin Pharmaceutical Inc., 105 Digital Dr, Novato, CA 94949, United States of America. Electronic address: orli.rosen@bmrn.com.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Larimore', 'Affiliation': 'Research and Development, BioMarin Pharmaceutical Inc., 105 Digital Dr, Novato, CA 94949, United States of America. Electronic address: KLarimore@bmrn.com.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Thomas', 'Affiliation': 'Department of Pediatrics, Section of Clinical Genetics and Metabolism, University of Colorado School of Medicine, 12605 E 16th St, Aurora, CO 80045, United States of America. Electronic address: janet.thomas@childrenscolorado.org.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Molecular genetics and metabolism,['10.1016/j.ymgme.2020.06.006'] 2101,32593555,Effectiveness of a brief advance directive intervention in primary care: a randomized clinical trial.,"OBJECTIVE To measure the effectiveness of a brief intervention aimed at increasing interest in and use of advanced directives (AD) among primary care patients. METHODS Randomized controlled trial. In the intervention arm, patients were given brief oral information and a leaflet on AD by General Practitioners (GPs), in the control group were briefly informed about the study's purpose. Outcome variables were the proportion of patients who expressed interest in AD and those who completed one. Covariates were sex, age, education, race, Charlson comorbidity index (CCI), religion, and possession of financial will. RESULTS Overall, 332 patients were recruited; 58 in the intervention and 36 in the control group expressed interest in AD (p = 0.033) and 18 (5.4 %) made an AD (nine in each group). Variables associated with interest were Caucasian race (odds ratio [OR], 1.88), the intervention (OR, 1.86), and CCI extreme scores (OR, 0.36). Variables associated with AD completion were primary education/no schooling (OR, 5.69) and fewer children (OR, 0.57). CONCLUSIONS A brief oral and written intervention delivered by GP significantly increased interest in AD and achieved a completion rate of 5.4 %, without differences with the control group. PRACTICE IMPLICATIONS AD interventions should focus on individuals already likely to be motivated.",2020,"CONCLUSIONS A brief oral and written intervention delivered by GP significantly increased interest in AD and achieved a completion rate of 5.4 %, without differences with the control group. ","['primary care', 'primary care patients']",['brief advance directive intervention'],"['CCI extreme scores', 'completion rate']","[{'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0001683', 'cui_str': 'Advance Directives'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C4546361', 'cui_str': 'Charlson Comorbidity Index'}, {'cui': 'C0205403', 'cui_str': 'Extreme'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]",332.0,0.0561145,"CONCLUSIONS A brief oral and written intervention delivered by GP significantly increased interest in AD and achieved a completion rate of 5.4 %, without differences with the control group. ","[{'ForeName': 'Yolanda', 'Initials': 'Y', 'LastName': 'Rando-Matos', 'Affiliation': ""Centre d'Atenció Primària Florida Nord, Direcció d'Atenció Primària Costa de Ponent, Catalan Health Institute (ICS), L'Hospitalet de Llobregat, Barcelona, Spain; University Institute in Primary Care Research Jordi Gol (IDIAP Jordi Gol), Barcelona, Spain; Universitat Autònoma de Barcelona, Bellaterra (Cerdanyola del Vallès), Spain. Electronic address: yrando@ambitcp.catsalut.net.""}, {'ForeName': 'Toni', 'Initials': 'T', 'LastName': 'Vives-Argilagós', 'Affiliation': ""Centre d'Atenció Primària Florida Nord, Direcció d'Atenció Primària Costa de Ponent, Catalan Health Institute (ICS), L'Hospitalet de Llobregat, Barcelona, Spain. Electronic address: 22793ava@gmail.com.""}, {'ForeName': 'Estrella', 'Initials': 'E', 'LastName': 'Rodero-Pérez', 'Affiliation': ""Centre d'Atenció Primària Florida Nord, Direcció d'Atenció Primària Costa de Ponent, Catalan Health Institute (ICS), L'Hospitalet de Llobregat, Barcelona, Spain. Electronic address: 24698erp@gmail.com.""}, {'ForeName': 'Lluís', 'Initials': 'L', 'LastName': 'Solsona-Díaz', 'Affiliation': ""Centre d'Atenció Primària Florida Nord, Direcció d'Atenció Primària Costa de Ponent, Catalan Health Institute (ICS), L'Hospitalet de Llobregat, Barcelona, Spain. Electronic address: lsolsona@ambitcp.catsalut.net.""}, {'ForeName': 'José Luis', 'Initials': 'JL', 'LastName': 'Ballvé-Moreno', 'Affiliation': ""Centre d'Atenció Primària Florida Nord, Direcció d'Atenció Primària Costa de Ponent, Catalan Health Institute (ICS), L'Hospitalet de Llobregat, Barcelona, Spain; Universitat de Barcelona, Barcelona, Spain. Electronic address: ballvejl@gmail.com.""}, {'ForeName': 'Noemí', 'Initials': 'N', 'LastName': 'Moreno-Farrés', 'Affiliation': ""Centre d'Atenció Primària Florida Nord, Direcció d'Atenció Primària Costa de Ponent, Catalan Health Institute (ICS), L'Hospitalet de Llobregat, Barcelona, Spain. Electronic address: nmoreno@ambitcp.catsalut.net.""}, {'ForeName': 'Rosa', 'Initials': 'R', 'LastName': 'Sorando-Alastruey', 'Affiliation': ""Centre d'Atenció Primària Florida Nord, Direcció d'Atenció Primària Costa de Ponent, Catalan Health Institute (ICS), L'Hospitalet de Llobregat, Barcelona, Spain. Electronic address: rsorando@ambitcp.catsalut.net.""}, {'ForeName': 'Raquel', 'Initials': 'R', 'LastName': 'Adroer-Martori', 'Affiliation': ""Centre d'Atenció Primària Florida Nord, Direcció d'Atenció Primària Costa de Ponent, Catalan Health Institute (ICS), L'Hospitalet de Llobregat, Barcelona, Spain. Electronic address: madroer@ambitcp.catsalut.net.""}, {'ForeName': 'Núria', 'Initials': 'N', 'LastName': 'Sanfeliu-Soto', 'Affiliation': ""Centre d'Atenció Primària Florida Nord, Direcció d'Atenció Primària Costa de Ponent, Catalan Health Institute (ICS), L'Hospitalet de Llobregat, Barcelona, Spain. Electronic address: nsanfeliu@ambitcp.catsalut.net.""}, {'ForeName': 'Jesús', 'Initials': 'J', 'LastName': 'Almeda-Ortega', 'Affiliation': ""University Institute in Primary Care Research Jordi Gol (IDIAP Jordi Gol), Barcelona, Spain; Universitat Autònoma de Barcelona, Bellaterra (Cerdanyola del Vallès), Spain; Unitat de Suport a la Recerca Costa de Ponent, Direcció d'Atenció Primària Costa de Ponent, Catalan Health Institute (ICS), Cornellà de Llobregat, Barcelona, Spain. Electronic address: jalmeda@ambitcp.catsalut.net.""}]",Patient education and counseling,['10.1016/j.pec.2020.06.018'] 2102,32593627,Modified circumcision using the disposable circumcision suture device in children: a randomized controlled trial.,"OBJECTIVE To evaluate and compare the surgical outcomes and complications of the modified circumcision using disposable circumcision suture device (device group) and the conventional dorsal slit circumcision (conventional group) in children. METHODS A total of 284 patients were randomized to either device group or conventional group. All patients were preoperatively assessed and evaluated at 4 weeks after surgery. The perioperative data and postoperative outcomes were compared between the two groups. RESULTS No statistical differences were observed in the average age and indications between the two groups preoperatively (p>0.05). Compared with the conventional group, patients in the device group were shorter mean operative time, less blood loss, lower intraoperative and postoperative pain score, faster incision healing time and a higher satisfaction rate of penile cosmetic appearance (p<0.01). Similarly, the incidences of complication were significantly lower in the device group than in the conventional group (4.3% vs 12.3%, p<0.05). CONCLUSIONS The modified circumcision using disposable circumcision suture device is a simple, safe, faster, and effective procedure and may become the attractive alternative to the conventional technique for the children, with a relatively lower complication rate and better cosmetic results. With the improvement of disposable circumcision suture device, the modified circumcision using disposable circumcision suture device has the potential to be widely used in the world.",2020,No statistical differences were observed in the average age and indications between the two groups preoperatively (p>0.05).,"['284 patients', 'children']","['device group or conventional group', 'disposable circumcision suture device (device group) and the conventional dorsal slit circumcision (conventional group', 'Modified circumcision using the disposable circumcision suture device']","['perioperative data and postoperative outcomes', 'incidences of complication', 'shorter mean operative time, less blood loss, lower intraoperative and postoperative pain score, faster incision healing time and a higher satisfaction rate of penile cosmetic appearance']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0008819', 'cui_str': 'Circumcision'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0184904', 'cui_str': 'Slitting'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0030851', 'cui_str': 'Penile structure'}, {'cui': 'C0010164', 'cui_str': 'Cosmetic'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}]",284.0,0.0262913,No statistical differences were observed in the average age and indications between the two groups preoperatively (p>0.05).,"[{'ForeName': 'Jian-Ming', 'Initials': 'JM', 'LastName': 'Rao', 'Affiliation': ""Department of Urology, Fourth Hospital of Changsha, Hunan Normal University, Changsha, Hunan Province, 410007, China; Department of Urology, The Second Hunan Provincial People's Hospital, Hunan Traditional Chinese Medical University, Changsha, Hunan Province, 410007, China.""}, {'ForeName': 'He', 'Initials': 'H', 'LastName': 'Huang', 'Affiliation': 'Department of Urology, Fourth Hospital of Changsha, Hunan Normal University, Changsha, Hunan Province, 410007, China.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Chen', 'Affiliation': 'Department of Urology, Fourth Hospital of Changsha, Hunan Normal University, Changsha, Hunan Province, 410007, China.'}, {'ForeName': 'Chun-Gang', 'Initials': 'CG', 'LastName': 'Yang', 'Affiliation': 'Department of Urology, Fourth Hospital of Changsha, Hunan Normal University, Changsha, Hunan Province, 410007, China.'}, {'ForeName': 'Ci-Zhong', 'Initials': 'CZ', 'LastName': 'Pan', 'Affiliation': 'Department of Urology, Fourth Hospital of Changsha, Hunan Normal University, Changsha, Hunan Province, 410007, China.'}, {'ForeName': 'Guang-Cheng', 'Initials': 'GC', 'LastName': 'Deng', 'Affiliation': 'Department of Urology, Fourth Hospital of Changsha, Hunan Normal University, Changsha, Hunan Province, 410007, China.'}, {'ForeName': 'Long-Jiang', 'Initials': 'LJ', 'LastName': 'Shen', 'Affiliation': 'Department of Urology, Fourth Hospital of Changsha, Hunan Normal University, Changsha, Hunan Province, 410007, China.'}, {'ForeName': 'Xiao-Hui', 'Initials': 'XH', 'LastName': 'Qian', 'Affiliation': 'Department of Urology, Fourth Hospital of Changsha, Hunan Normal University, Changsha, Hunan Province, 410007, China.'}, {'ForeName': 'Mei-Kang', 'Initials': 'MK', 'LastName': 'Peng', 'Affiliation': 'Department of Urology, Fourth Hospital of Changsha, Hunan Normal University, Changsha, Hunan Province, 410007, China.'}, {'ForeName': 'Hui-Dong', 'Initials': 'HD', 'LastName': 'Zhou', 'Affiliation': 'Department of Urology, Fourth Hospital of Changsha, Hunan Normal University, Changsha, Hunan Province, 410007, China.'}, {'ForeName': 'Hong-Liang', 'Initials': 'HL', 'LastName': 'Peng', 'Affiliation': 'Department of Urology, Fourth Hospital of Changsha, Hunan Normal University, Changsha, Hunan Province, 410007, China.'}]",Urology,['10.1016/j.urology.2020.06.018'] 2103,32593717,Caring for older veterans with chronic low back pain using a geriatric syndrome approach: Rationale and methods for the aging back clinics (ABC) trial.,"The purpose of the ongoing trial is to improve care of older Veterans with chronic low back pain (CLBP, i.e., low back pain for ≥6 months on ≥ half the days). Current CLBP care is limited by being either overly spine-focused or non-specifically prescribed and both approaches frequently lead to suboptimal reduction in pain and improvement in function. Through prior studies we have laid the foundation for a patient-centered approach to care for older Veterans with CLBP in which the spine is a source of vulnerability but not the sole treatment target. The approach considers CLBP a geriatric syndrome, a final common pathway for the expression of multiple contributors rather than a disease of the spine. We describe here the rationale and design of a randomized controlled trial to test the efficacy of an older Veteran-centered approach to CLBP care in ""Aging Back Clinics (ABCs)"" compared with Usual Care (UC). Three hundred thirty Veterans age 65-89 with CLBP will be randomized to ABCs or UC and followed for 12 months after randomization. We will assess the impact of ABCs on our primary outcome of pain-associated disability with the Oswestry Disability Index at 6 and 12 months, and secondary outcomes of pain intensity, health-related quality of life, balance confidence, mobility and healthcare utilization. If shown efficacious, the approach tested in ABCs has the potential to transform the care of older adults with CLBP by improving the quality of life for millions, reducing morbidity and saving substantial healthcare costs.",2020,"If shown efficacious, the approach tested in ABCs has the potential to transform the care of older adults with CLBP by improving the quality of life for millions, reducing morbidity and saving substantial healthcare costs.","['Three hundred thirty Veterans age 65-89 with CLBP', 'older Veterans with chronic low back pain (CLBP, i.e., low back pain for ≥6\u202fmonths on ≥ half the days', 'older veterans with chronic low back pain using a geriatric syndrome approach', 'older adults with CLBP']","['ABCs or UC', 'older Veteran-centered approach to CLBP care', 'Usual Care (UC']","['pain-associated disability with the Oswestry Disability Index', 'pain intensity, health-related quality of life, balance confidence, mobility and healthcare utilization']","[{'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0017469', 'cui_str': 'Geriatric medicine'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0042153', 'cui_str': 'utilization'}]",330.0,0.0631505,"If shown efficacious, the approach tested in ABCs has the potential to transform the care of older adults with CLBP by improving the quality of life for millions, reducing morbidity and saving substantial healthcare costs.","[{'ForeName': 'Debra K', 'Initials': 'DK', 'LastName': 'Weiner', 'Affiliation': 'Geriatric Research, Education and Clinic Center, VA Pittsburgh Healthcare System, Pittsburgh, PA, United States of America; University of Pittsburgh School of Medicine, Pittsburgh, PA, United States of America. Electronic address: debra.weiner@va.gov.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Gentili', 'Affiliation': 'Central Virginia VA Health Care System, Richmond, VA, United States of America; Virginia Commonwealth University Health System, Richmond, VA.'}, {'ForeName': 'Meika A', 'Initials': 'MA', 'LastName': 'Fang', 'Affiliation': 'Geriatric Research, Education and Clinical Center, VA Greater Los Angeles Healthcare System, Los Angeles, CA, United States of America; David Geffen School of Medicine at UCLA Los Angeles, Los Angeles, CA, United States of America.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Garay', 'Affiliation': 'VA Pittsburgh Healthcare System, Pittsburgh, PA, United States of America.'}, {'ForeName': 'Thiru', 'Initials': 'T', 'LastName': 'Annaswamy', 'Affiliation': 'VA North Texas Health Care System, Dallas, TX, United States of America; University of Texas Southwestern Medical Center, Dallas, TX, United States of America.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Castle', 'Affiliation': 'Geriatric Research, Education and Clinical Center, VA Greater Los Angeles Healthcare System, Los Angeles, CA, United States of America; David Geffen School of Medicine at UCLA Los Angeles, Los Angeles, CA, United States of America.'}, {'ForeName': 'Lenore', 'Initials': 'L', 'LastName': 'Joseph', 'Affiliation': 'Central Virginia VA Health Care System, Richmond, VA, United States of America; Virginia Commonwealth University Health System, Richmond, VA.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Lawson', 'Affiliation': 'Central Virginia VA Health Care System, Richmond, VA, United States of America; Virginia Commonwealth University Health System, Richmond, VA.'}, {'ForeName': 'Cathy C', 'Initials': 'CC', 'LastName': 'Lee', 'Affiliation': 'Geriatric Research, Education and Clinical Center, VA Greater Los Angeles Healthcare System, Los Angeles, CA, United States of America; David Geffen School of Medicine at UCLA Los Angeles, Los Angeles, CA, United States of America.'}, {'ForeName': 'Una E', 'Initials': 'UE', 'LastName': 'Makris', 'Affiliation': 'VA North Texas Health Care System, Dallas, TX, United States of America; University of Texas Southwestern Medical Center, Dallas, TX, United States of America.'}, {'ForeName': 'Michelle I', 'Initials': 'MI', 'LastName': 'Rossi', 'Affiliation': 'Geriatric Research, Education and Clinic Center, VA Pittsburgh Healthcare System, Pittsburgh, PA, United States of America; University of Pittsburgh School of Medicine, Pittsburgh, PA, United States of America.'}, {'ForeName': 'Beverly', 'Initials': 'B', 'LastName': 'Thorn', 'Affiliation': 'University of Alabama, Tuscaloosa, AL, United States of America.'}, {'ForeName': 'Kimberly', 'Initials': 'K', 'LastName': 'Clemens', 'Affiliation': 'Geriatric Research, Education and Clinic Center, VA Pittsburgh Healthcare System, Pittsburgh, PA, United States of America.'}, {'ForeName': 'Dave', 'Initials': 'D', 'LastName': 'Newman', 'Affiliation': 'Geriatric Research, Education and Clinic Center, VA Pittsburgh Healthcare System, Pittsburgh, PA, United States of America.'}, {'ForeName': 'Subashan', 'Initials': 'S', 'LastName': 'Perera', 'Affiliation': 'University of Pittsburgh School of Medicine, Pittsburgh, PA, United States of America; University of Pittsburgh Graduate School of Public Health, United States of America.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106077'] 2104,32593750,Effect of acute caffeine intake on hit accuracy and reaction time in professional e-sports players.,"Caffeine is considered a cognitive enhancer at low to moderate doses because it improves alertness, vigilance, attention, and reaction time. However, no previous investigation has assessed the effect of acute caffeine intake on e-sports-specific performance. The aim of this investigation was to determine the effect of the ingestion of 3 mg per kg of body mass on simple reaction time in a color test and on hit accuracy and reaction time during a first-person shooting game. Fifteen professional e-gamers (age= 22 ± 3 years) participated in a double-blind, cross-over, randomized experimental trial. In two trials 3 days apart, participants either ingested a placebo (cellulose) or 3 mg/kg of caffeine in an opaque and unidentifiable capsule. After a 45-min wait for substance absorption, participants performed 5 attempts at a simple reaction time test and completed a first-person shooting game that included 3 attempts at a 2-min game with 60 fixed targets (180 targets in total). Reaction times (in both tests) and accuracy in hitting the targets (only in the shooting game) were measured. In comparison to the placebo, caffeine decreased simple reaction time (0.20 ± 0.01 vs. 0.19 ± 0.01 s, P < 0.01), the mean time taken to hit the targets (0.92 ± 0.07 vs. 0.88 ± 0.07 s, P < 0.01) and enhanced hit accuracy (98.8 ± 0.92 vs. 99.8 ± 0.35% of targets hit, P < 0.01). In summary, the acute ingestion of 3 mg/kg of caffeine reduced the time taken to react to a simple stimulus, decreased the time taken to hit a fixed target and improved accuracy in hitting the target in a first-person shooting game in professional e-gamers. Thus, the caffeine ingestion (3 mg/kg) might be considered as an ergogenic aid for e-sports gamers based on its effect to enhance hit accuracy and time.",2020,"In comparison to the placebo, caffeine decreased simple reaction time (0.20 ± 0.01 vs. 0.19 ± 0.01 s, P < 0.01), the mean time taken to hit the targets (0.92 ± 0.07 vs. 0.88 ± 0.07 s, P < 0.01) and enhanced hit accuracy (98.8 ± 0.92 vs. 99.8 ± 0.35% of targets hit, P < 0.01).","['Fifteen professional e-gamers (age= 22 ± 3 years) participated in a double-blind, cross-over, randomized experimental trial', 'professional e-sports players']","['acute caffeine intake', 'caffeine ingestion', 'caffeine', 'placebo (cellulose) or 3 mg/kg of caffeine', 'Caffeine', 'placebo, caffeine']","['enhanced hit accuracy', 'time taken to hit a fixed target and improved accuracy', 'alertness, vigilance, attention, and reaction time', 'simple reaction time', 'Reaction times', 'hit accuracy and reaction time', 'mean time taken to hit the targets']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}, {'cui': 'C0010366', 'cui_str': 'Genetic crossing over'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0038039', 'cui_str': 'Sport'}]","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}]","[{'cui': 'C0272285', 'cui_str': 'Heparin-induced thrombocytopenia'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0043012', 'cui_str': 'Wakefulness'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",,0.0879569,"In comparison to the placebo, caffeine decreased simple reaction time (0.20 ± 0.01 vs. 0.19 ± 0.01 s, P < 0.01), the mean time taken to hit the targets (0.92 ± 0.07 vs. 0.88 ± 0.07 s, P < 0.01) and enhanced hit accuracy (98.8 ± 0.92 vs. 99.8 ± 0.35% of targets hit, P < 0.01).","[{'ForeName': 'Ignacio', 'Initials': 'I', 'LastName': 'Sainz', 'Affiliation': 'Team Queso, e-Gamers Club. Madrid, Spain. Electronic address: nachosainz10@gmail.com.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Collado-Mateo', 'Affiliation': 'Centre for Sport Studies, Rey Juan Carlos University, Fuenlabrada, Madrid, Spain. Electronic address: daniel.collado@urjc.es.'}, {'ForeName': 'Juan Del', 'Initials': 'JD', 'LastName': 'Coso', 'Affiliation': 'Centre for Sport Studies, Rey Juan Carlos University, Fuenlabrada, Madrid, Spain. Electronic address: juan.delcoso@urjc.es.'}]",Physiology & behavior,['10.1016/j.physbeh.2020.113031'] 2105,32593753,Correlation between effectual time and the curative effect in patients with all frequency descending sudden deafness after treatment.,"OBJECTIVE To discuss the correlation between effectual time and the curative effect in patients with all frequency descending sudden deafness. METHODS According to effectual time, the subjects were divided into first week effectual group and second week effectual group and the curative effect of each group was compared. RESULTS In patients with flat descent sudden deafness, the curative rate of the first week effectual group was higher than that of the second week effectual group, but there was no significant difference between the two groups (χ 2  = 1.584, P = 0.208). Meanwhile, the total significant effective rate of the first week effectual group was higher than that of the second week effectual group, without obvious difference between the two groups (χ 2  = 0.227, P = 0.634). Furthermore, in patients with total deafness type of sudden deafness, the curative rate of the first week effectual group was higher than that of the second week effectual group, showing no remarkable difference between the two groups (χ 2  = 2.726, P = 0.099). Besides, there was no remarkable difference in the comparison of the total significant effective rate (χ 2  = 2.933, P = 0.087), which was higher in the first week effectual group than that in the second week effectual group. CONCLUSION The course of treatment should be at least 2 weeks in patients with all frequency descending sudden deafness after onset.",2020,"Besides, there was no remarkable difference in the comparison of the total significant effective rate (χ 2  = 2.933, P = 0.087), which was higher in the first week effectual group than that in the second week effectual group. ","['patients with all frequency descending sudden deafness after treatment', 'patients with all frequency descending sudden deafness']",[],"['curative rate', 'total significant effective rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0205386', 'cui_str': 'Descending'}, {'cui': 'C1148477', 'cui_str': 'Sudden Deafness'}, {'cui': 'C0001758', 'cui_str': 'Aftercare'}]",[],"[{'cui': 'C1276305', 'cui_str': 'Curative - procedure intent'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",,0.014918,"Besides, there was no remarkable difference in the comparison of the total significant effective rate (χ 2  = 2.933, P = 0.087), which was higher in the first week effectual group than that in the second week effectual group. ","[{'ForeName': 'Jian-Ping', 'Initials': 'JP', 'LastName': 'Si', 'Affiliation': 'Handan Central Hospital, Handan, Hebei 056000, China. Electronic address: sjpemail@126.com.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Jiang', 'Affiliation': 'Handan Central Hospital, Handan, Hebei 056000, China.'}, {'ForeName': 'Yan-Yan', 'Initials': 'YY', 'LastName': 'Li', 'Affiliation': 'Handan Central Hospital, Handan, Hebei 056000, China.'}]",American journal of otolaryngology,['10.1016/j.amjoto.2020.102621'] 2106,32485945,"Sprint Interval Running and Continuous Running Produce Training Specific Adaptations, Despite a Similar Improvement of Aerobic Endurance Capacity-A Randomized Trial of Healthy Adults.","The purpose of the present study was to investigate training-specific adaptations to eight weeks of moderate intensity continuous training (CT) and sprint interval training (SIT). Young healthy subjects ( n = 25; 9 males and 16 females) performed either continuous training (30-60 min, 70-80% peak heart rate) or sprint interval training (5-10 near maximal 30 s sprints, 3 min recovery) three times per week for eight weeks. Maximal oxygen consumption, 20 m shuttle run test and 5·60 m sprint test were performed before and after the intervention. Furthermore, heart rate, oxygen pulse, respiratory exchange ratio, lactate and running economy were assessed at five submaximal intensities, before and after the training interventions. Maximal oxygen uptake increased after CT (before: 47.9 ± 1.5; after: 49.7 ± 1.5 mL·kg -1 ·min -1 , p < 0.05) and SIT (before: 50.5 ± 1.6; after: 53.3 ± 1.5 mL·kg -1 ·min -1 , p < 0.01), with no statistically significant differences between groups. Both groups increased 20 m shuttle run performance and 60 m sprint performance, but SIT performed better than CT at the 4th and 5th 60 m sprint after the intervention ( p < 0.05). At submaximal intensities, CT, but not SIT, reduced heart rate ( p < 0.05), whereas lactate decreased in both groups. In conclusion, both groups demonstrated similar improvements of several performance measures including VO 2max , but sprint performance was better after SIT, and CT caused training-specific adaptations at submaximal intensities.",2020,"Both groups increased 20 m shuttle run performance and 60 m sprint performance, but SIT performed better than CT at the 4th and 5th 60 m sprint after the intervention ( p < 0.05).","['Healthy Adults', 'Young healthy subjects ( n = 25; 9 males and 16 females']","['continuous training', 'moderate intensity continuous training (CT) and sprint interval training (SIT', 'Sprint Interval Running and Continuous Running Produce Training Specific Adaptations', 'sprint interval training']","['Maximal oxygen consumption, 20 m shuttle run test and 5·60 m sprint test', 'lactate', 'Maximal oxygen uptake', 'heart rate', 'Furthermore, heart rate, oxygen pulse, respiratory exchange ratio, lactate and running economy', '20 m shuttle run performance and 60 m sprint performance', 'several performance measures including VO 2max , but sprint performance']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C4279979', 'cui_str': 'Sprint Interval Training'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0035953', 'cui_str': 'Running'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0000934', 'cui_str': 'Acclimation'}]","[{'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0034107', 'cui_str': 'Pulse taking'}, {'cui': 'C0429702', 'cui_str': 'Respiratory quotient'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0332257', 'cui_str': 'Including'}]",,0.025306,"Both groups increased 20 m shuttle run performance and 60 m sprint performance, but SIT performed better than CT at the 4th and 5th 60 m sprint after the intervention ( p < 0.05).","[{'ForeName': 'Sigbjørn', 'Initials': 'S', 'LastName': 'Litleskare', 'Affiliation': 'Department of Physical Performance, Norwegian School of Sport Sciences, 0863 Oslo, Norway.'}, {'ForeName': 'Eystein', 'Initials': 'E', 'LastName': 'Enoksen', 'Affiliation': 'Department of Physical Performance, Norwegian School of Sport Sciences, 0863 Oslo, Norway.'}, {'ForeName': 'Marit', 'Initials': 'M', 'LastName': 'Sandvei', 'Affiliation': 'Department of Physical Performance, Norwegian School of Sport Sciences, 0863 Oslo, Norway.'}, {'ForeName': 'Line', 'Initials': 'L', 'LastName': 'Støen', 'Affiliation': 'Department of Physical Performance, Norwegian School of Sport Sciences, 0863 Oslo, Norway.'}, {'ForeName': 'Trine', 'Initials': 'T', 'LastName': 'Stensrud', 'Affiliation': 'Department of Physical Performance, Norwegian School of Sport Sciences, 0863 Oslo, Norway.'}, {'ForeName': 'Egil', 'Initials': 'E', 'LastName': 'Johansen', 'Affiliation': 'Department of Physical Performance, Norwegian School of Sport Sciences, 0863 Oslo, Norway.'}, {'ForeName': 'Jørgen', 'Initials': 'J', 'LastName': 'Jensen', 'Affiliation': 'Department of Physical Performance, Norwegian School of Sport Sciences, 0863 Oslo, Norway.'}]",International journal of environmental research and public health,['10.3390/ijerph17113865'] 2107,32488368,Footprint preparation with nanofractures in a supraspinatus repair cuts in half the retear rate at 1-year follow-up. A randomized controlled trial.,"PURPOSE To evaluate if adding nanofractures to the footprint of a supraspinatus tear repair would have any effect in the outcomes at one-year follow-up. METHODS Multicentric, triple-blinded, randomized trial with 12-months follow-up. Subjects with isolated symptomatic reparable supraspinatus tears smaller than 3 cm and without grade 4 fatty infiltration were included. These were randomized to two groups: In the Control group an arthroscopic supraspinatus repair was performed; in the Nanofracture group the footprint was additionally prepared with nanofractures (1 mm wide, 9 mm deep microfractures). Clinical evaluation was done with Constant score, EQ-5D-3L, and Brief Pain Inventory. The primary outcome was the retear rate in MRI at 12-months follow-up. Secondary outcomes were: characteristics of the retear (at the footprint or at the musculotendinous junction) and clinical outcomes. RESULTS Seventy-one subjects were randomized. Two were lost to follow-up, leaving 69 participants available for assessment at 12-months follow-up (33 in the Control group and 36 in the Nanofracture Group). The Nanofracture group had lower retear rates than the Control group (7/36 [19.4%] vs 14/33 [42.4%], differences significant, p = 0.038). Retear rates at the musculotendinous junction were similar but the Nanofracture group had better tendon healing rates to the bone (34/36 [94.4%] vs. 24/33 [66.71%], p = 0.014). Clinically both groups had significant improvements, but no differences were found between groups. CONCLUSION Adding nanofractures at the footprint during an isolated supraspinatus repair lowers in half the retear rate at 12-months follow-up. This is due to improved healing at the footprint. LEVEL OF EVIDENCE Level I.",2020,"Retear rates at the musculotendinous junction were similar but the Nanofracture group had better tendon healing rates to the bone (34/36 [94.4%] vs. 24/33 [66.71%], p = 0.014).","['Subjects with isolated symptomatic reparable supraspinatus tears smaller than 3\xa0cm and without grade 4 fatty infiltration were included', 'Seventy-one subjects were randomized']",['arthroscopic supraspinatus repair'],"['tendon healing rates', 'characteristics of the retear (at the footprint or at the musculotendinous junction) and clinical outcomes', 'retear rates', 'retear rate in MRI', 'Constant score, EQ-5D-3L, and Brief Pain Inventory']","[{'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0439059', 'cui_str': 'Supraspinatus tear'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C3537125', 'cui_str': 'Common terminology criteria for adverse events grade 4'}, {'cui': 'C0333575', 'cui_str': 'Fatty infiltration'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0450389', 'cui_str': '71'}]","[{'cui': 'C0584869', 'cui_str': 'Supraspinatus muscle structure'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}]","[{'cui': 'C0039508', 'cui_str': 'Tendon structure'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0584646', 'cui_str': 'Musculotendinous junction'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C1720529', 'cui_str': 'Constant'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}]",71.0,0.122116,"Retear rates at the musculotendinous junction were similar but the Nanofracture group had better tendon healing rates to the bone (34/36 [94.4%] vs. 24/33 [66.71%], p = 0.014).","[{'ForeName': 'Miguel Angel', 'Initials': 'MA', 'LastName': 'Ruiz Ibán', 'Affiliation': 'Unidad de Hombro y Codo, Hospital Universitario Ramón y Cajal, Cta Colmenar km 9,100, 28046, Madrid, Spain. drmri@hotmail.com.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Sanchez Alepuz', 'Affiliation': 'Hospital IMED Valencia, Valencia, Spain.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Diaz Heredia', 'Affiliation': 'Unidad de Hombro y Codo, Hospital Universitario Ramón y Cajal, Cta Colmenar km 9,100, 28046, Madrid, Spain.'}, {'ForeName': 'Abdul-Ilah', 'Initials': 'AI', 'LastName': 'Hachem', 'Affiliation': 'Head of the Shoulder Unit, Hospital Universitario de Bellvitge, Barcelona, Spain.'}, {'ForeName': 'Leon', 'Initials': 'L', 'LastName': 'Ezagüi Bentolila', 'Affiliation': 'Hospital Egarsat, Barcelona, Spain.'}, {'ForeName': 'Angel', 'Initials': 'A', 'LastName': 'Calvo', 'Affiliation': 'Arthrosport, Zaragoza, Spain.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Verdú', 'Affiliation': 'Unidad de Hombro y Codo, Hospital General Universitario de Elche, Elche, Alicante, Spain.'}, {'ForeName': 'Ignacio', 'Initials': 'I', 'LastName': 'de Rus Aznar', 'Affiliation': 'Unidad de Hombro y Codo, Hospital Universitario Ramón y Cajal, Cta Colmenar km 9,100, 28046, Madrid, Spain.'}, {'ForeName': 'Francesc', 'Initials': 'F', 'LastName': 'Soler Romagosa', 'Affiliation': 'Traumadvance, Terrassa, Barcelona, Spain.'}]","Knee surgery, sports traumatology, arthroscopy : official journal of the ESSKA",['10.1007/s00167-020-06073-7'] 2108,32485622,Effects of cognitive-behavioural therapy for stress management on stress and hair cortisol levels in pregnant women: A randomised controlled trial.,"OBJECTIVE To demonstrate the effectiveness of a cognitive behavioural therapy for stress management in pregnant women in the reduction of psychological stress and hair cortisol levels. METHODS The trial was controlled and randomised, with a total of 78 pregnant women: control group (n-39) and Cognitive Behavioural Therapy group (n-39). To test the therapy's efficacy, an evaluation of the primary outcome (hair cortisol levels) and secondary outcomes (psychological stress, psychopathological symptomatology and resilience) was conducted before and after the treatment. The therapy was conducted during 8 sessions (one per week) in a group setting. The study was registered as a Randomised Controlled Trial with the code NCT03404141. RESULTS The results showed a group time interaction between hair cortisol levels, psychological stress (perceived and pregnancy-specific), and in the exacerbation and severity of psychopathological symptoms. These variables presented reductions after treatment only in the Cognitive Behavioural Therapy group. CONCLUSIONS Using a novel way of assessing chronic stress (psychological and objective measures as hair cortisol levels), this is the first study that has shown a decrease in both the levels of cortisol in hair and in psychological stress. This decline could have implications for maternal and fetal health.",2020,"These variables presented reductions after treatment only in the Cognitive Behavioural Therapy group. ","['78 pregnant women', 'pregnant women in the reduction of psychological stress and hair cortisol levels', 'pregnant women']","['cognitive behavioural therapy', 'cognitive-behavioural therapy', 'control group (n-39) and Cognitive Behavioural Therapy group (n-39']","['hair cortisol levels, psychological stress (perceived and pregnancy-specific), and in the exacerbation and severity of psychopathological symptoms', 'primary outcome (hair cortisol levels) and secondary outcomes (psychological stress, psychopathological symptomatology and resilience', 'stress and hair cortisol levels']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0038443', 'cui_str': 'Psychological Stress'}, {'cui': 'C0018494', 'cui_str': 'Hair structure'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0018494', 'cui_str': 'Hair structure'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement'}, {'cui': 'C0038443', 'cui_str': 'Psychological Stress'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0683253', 'cui_str': 'Psychological resilience'}, {'cui': 'C0038435', 'cui_str': 'Stress'}]",78.0,0.0699261,"These variables presented reductions after treatment only in the Cognitive Behavioural Therapy group. ","[{'ForeName': 'Borja', 'Initials': 'B', 'LastName': 'Romero-Gonzalez', 'Affiliation': 'Brain, Mind and Behavior Research Center (CIMCYC), Faculty of Psychology, University of Granada, Granada, Spain; Department of Personality, Assessment and Psychological Treatment, University of Granada, Granada, Spain.'}, {'ForeName': 'Jose A', 'Initials': 'JA', 'LastName': 'Puertas-Gonzalez', 'Affiliation': 'Brain, Mind and Behavior Research Center (CIMCYC), Faculty of Psychology, University of Granada, Granada, Spain; Department of Personality, Assessment and Psychological Treatment, University of Granada, Granada, Spain.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Strivens-Vilchez', 'Affiliation': 'Midwifery Department, Gongora Primary Health Center, Granada, Spain.'}, {'ForeName': 'Raquel', 'Initials': 'R', 'LastName': 'Gonzalez-Perez', 'Affiliation': 'Department of Pharmacology, CIBERehd, School of Pharmacy, Instituto de Investigación Biosanitariaibs.GRANADA, University of Granada, Granada, Spain. Electronic address: raquel.gonzalez@ciberehd.org.'}, {'ForeName': 'M Isabel', 'Initials': 'MI', 'LastName': 'Peralta-Ramirez', 'Affiliation': 'Department of Personality, Assessment and Psychological Treatment, University of Granada, Granada, Spain.'}]",Journal of psychosomatic research,['10.1016/j.jpsychores.2020.110162'] 2109,32485633,Effect of hippotherapy on walking performance and gait parameters in people with multiple sclerosis.,"BACKGROUND Walking dysfunction is one of the most common symptoms of multiple sclerosis (MS). OBJECTIVE To evaluate the effects of an 8-week hippotherapy intervention on walking performance and spatiotemporal gait parameters in people with relapsing-remitting MS; and to examine whether the effects of hippotherapy on walking performance are mediated by changes in spatiotemporal gait parameters. METHODS Participants were assigned into a hippotherapy intervention group (n = 17) or a control group (n = 16). The intervention included 16 sessions of 30-minutes of hippotherapy conducted twice a week. Participants underwent the 25-foot walk test (T25FW) and 6-minute walk test (6MWT), as primary outcomes, and spatiotemporal gait evaluation using GaitRite system, as secondary outcomes, before and after intervention. The data were examined using mixed model ANOVA with Bonferroni post hoc. Mediation analysis was conducted as per Baron and Kenny's criteria. RESULTS Compared with control, the intervention group significantly increased 6MWT distance (+9.70%, p<0.001) and decreased T25FW time (-15.86%, p<0.001).Regarding spatiotemporal gait parameters, the intervention group exhibited significantly greater improvements in most variables (Δ% from 3.66 and 41.43%; all p<0.005) than control. Only balance time (p = 0.043), stance time (p = 0.031), and absolute (p = 0.004) and relative (p = 0.017) double support time were identified as significant mediators of the effects of hippotherapy on walking performance evaluated by T25FW. There was no significant mediator for 6MWT (all p>0.05). CONCLUSION Hippotherapy improved walking performance and spatiotemporal gait parameters in people with relapsing-remitting MS, and changes in walking performance, evaluated by T25FW, were partially driven by reduction in stance time and double support time and increase in balance time. Hippotherapy may be a useful complimentary treatment approach for improving walking in people with MS.",2020,"Compared with control, the intervention group significantly increased 6MWT distance (+9.70%, p<0.001) and decreased T25FW time (-15.86%, p<0.001).Regarding spatiotemporal gait parameters, the intervention group exhibited significantly greater improvements in most variables (Δ% from 3.66 and 41.43%; all p<0.005) than control.","['people with relapsing-remitting MS', 'people with multiple sclerosis', 'Participants', 'people with MS']","['hippotherapy intervention', 'Hippotherapy', 'hippotherapy', '25-foot walk test (T25FW) and 6-minute walk test (6MWT']","['T25FW time', 'walking performance and spatiotemporal gait parameters', '6MWT distance', 'walking performance and gait parameters', 'stance time', 'balance time']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0751967', 'cui_str': 'Relapsing remitting multiple sclerosis'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}]","[{'cui': 'C0454416', 'cui_str': 'Hippotherapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0430515', 'cui_str': '6-minute walk test'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0430515', 'cui_str': '6-minute walk test'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}]",,0.0352318,"Compared with control, the intervention group significantly increased 6MWT distance (+9.70%, p<0.001) and decreased T25FW time (-15.86%, p<0.001).Regarding spatiotemporal gait parameters, the intervention group exhibited significantly greater improvements in most variables (Δ% from 3.66 and 41.43%; all p<0.005) than control.","[{'ForeName': 'Andréa Gomes', 'Initials': 'AG', 'LastName': 'Moraes', 'Affiliation': 'Laboratory of Human Motion Analysis, Faculty of Physical Education, University of Brasilia, Brasilia, DF, Brazil. Electronic address: deyafisio9@hotmail.com.'}, {'ForeName': 'Silvia Gonçalves Ricci', 'Initials': 'SGR', 'LastName': 'Neri', 'Affiliation': 'Laboratory of Human Motion Analysis, Faculty of Physical Education, University of Brasilia, Brasilia, DF, Brazil.'}, {'ForeName': 'Robert W', 'Initials': 'RW', 'LastName': 'Motl', 'Affiliation': 'Department of Physical Therapy, University of Alabama at Birmingham,Birmingham, AL, United States.'}, {'ForeName': 'Carlos Bernardo', 'Initials': 'CB', 'LastName': 'Tauil', 'Affiliation': 'Faculty of Medicine, University of Brasília, DF, Brazil.'}, {'ForeName': 'Felipe von', 'Initials': 'FV', 'LastName': 'Glehn', 'Affiliation': 'Department of Medical Clinic, Faculty of Medicine, University of Brasilia, Brasilia, DF and Department of Immunology, University of Unicamp, SP, Brazil.'}, {'ForeName': 'Éber Castro', 'Initials': 'ÉC', 'LastName': 'Corrêa', 'Affiliation': 'Clinen, Neurology and Endocrinology Clinic, Brasília, DF, Bazil.'}, {'ForeName': 'Ana Cristina', 'Initials': 'AC', 'LastName': 'de David', 'Affiliation': 'Laboratory of Human Motion Analysis, Faculty of Physical Education, University of Brasilia, Brasilia, DF, Brazil.'}]",Multiple sclerosis and related disorders,['10.1016/j.msard.2020.102203'] 2110,32485640,Improving B-mode ultrasound diagnostic performance for focal liver lesions using deep learning: A multicentre study.,"BACKGROUND The diagnosis performance of B-mode ultrasound (US) for focal liver lesions (FLLs) is relatively limited. We aimed to develop a deep convolutional neural network of US (DCNN-US) for aiding radiologists in classification of malignant from benign FLLs. MATERIALS AND METHODS This study was conducted in 13 hospitals and finally 2143 patients with 24,343 US images were enrolled. Patients who had non-cystic FLLs with pathological results were enrolled. The FLLs from 11 hospitals were randomly divided into training and internal validations (IV) cohorts with a 4:1 ratio for developing and evaluating DCNN-US. Diagnostic performance of the model was verified using external validation (EV) cohort from another two hospitals. The diagnosis value of DCNN-US was compared with that of contrast enhanced computed tomography (CT)/magnetic resonance image (MRI) and 236 radiologists, respectively. FINDINGS The AUC of Model LBC for FLLs was 0.924 (95% CI: 0.889-0.959) in the EV cohort. The diagnostic sensitivity and specificity of Model LBC were superior to 15-year skilled radiologists (86.5% vs 76.1%, p = 0.0084 and 85.5% vs 76.9%, p = 0.0051, respectively). Accuracy of Model LBC was comparable to that of contrast enhanced CT (both 84.7%) but inferior to contrast enhanced MRI (87.9%) for lesions detected by US. INTERPRETATION DCNN-US with high sensitivity and specificity in diagnosing FLLs shows its potential to assist less-experienced radiologists in improving their performance and lowering their dependence on sectional imaging in liver cancer diagnosis.",2020,"INTERPRETATION DCNN-US with high sensitivity and specificity in diagnosing FLLs shows its potential to assist less-experienced radiologists in improving their performance and lowering their dependence on sectional imaging in liver cancer diagnosis.","['focal liver lesions using deep learning', '11 hospitals', '13 hospitals and finally 2143 patients with 24,343 US images were enrolled', 'Patients who had non-cystic FLLs with pathological results were enrolled']",['deep convolutional neural network of US (DCNN-US'],"['AUC of Model LBC for FLLs', 'Diagnostic performance', 'diagnostic sensitivity and specificity of Model LBC were superior to 15-year skilled radiologists']","[{'cui': 'C0205234', 'cui_str': 'Focal'}, {'cui': 'C0577053', 'cui_str': 'Lesion of liver'}, {'cui': 'C4704761', 'cui_str': 'Hierarchical Learning'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0205207', 'cui_str': 'Cystic'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0678226', 'cui_str': 'Due to'}]","[{'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0242406', 'cui_str': 'Neural Networks (Anatomic)'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}]","[{'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C1318045', 'cui_str': 'AKAP13 protein, human'}, {'cui': 'C0205234', 'cui_str': 'Focal'}, {'cui': 'C0577053', 'cui_str': 'Lesion of liver'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0036668', 'cui_str': 'Sensitivity and Specificity'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0260194', 'cui_str': 'Radiologist'}]",2143.0,0.0256485,"INTERPRETATION DCNN-US with high sensitivity and specificity in diagnosing FLLs shows its potential to assist less-experienced radiologists in improving their performance and lowering their dependence on sectional imaging in liver cancer diagnosis.","[{'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Yang', 'Affiliation': 'Department of Interventional Ultrasound, Chinese PLA General Hospital, 28 Fuxing Road, Beijing 100853, China.'}, {'ForeName': 'Jingwei', 'Initials': 'J', 'LastName': 'Wei', 'Affiliation': 'Key Laboratory of Molecular Imaging, Institute of Automation, Chinese Academy of Sciences, Beijing, China; University of Chinese Academy of Sciences, Beijing, China.'}, {'ForeName': 'Xiaohan', 'Initials': 'X', 'LastName': 'Hao', 'Affiliation': 'Key Laboratory of Molecular Imaging, Institute of Automation, Chinese Academy of Sciences, Beijing, China; University of Chinese Academy of Sciences, Beijing, China; Centers for Biomedical Engineering, University of Science and Technology of China, University of Science and Technology of China, Hefei, China.'}, {'ForeName': 'Dexing', 'Initials': 'D', 'LastName': 'Kong', 'Affiliation': 'School of Mathematical Sciences, Zhejiang University, Hangzhou, China.'}, {'ForeName': 'Xiaoling', 'Initials': 'X', 'LastName': 'Yu', 'Affiliation': 'Department of Interventional Ultrasound, Chinese PLA General Hospital, 28 Fuxing Road, Beijing 100853, China.'}, {'ForeName': 'Tianan', 'Initials': 'T', 'LastName': 'Jiang', 'Affiliation': 'Department of Ultrasound, the First Affiliated hospital, College of Medicine, Zhejiang University, Hangzhou, Jiangsu, China.'}, {'ForeName': 'Junqing', 'Initials': 'J', 'LastName': 'Xi', 'Affiliation': 'Department of Interventional Ultrasound, Chinese PLA General Hospital, 28 Fuxing Road, Beijing 100853, China.'}, {'ForeName': 'Wenjia', 'Initials': 'W', 'LastName': 'Cai', 'Affiliation': 'Department of Interventional Ultrasound, Chinese PLA General Hospital, 28 Fuxing Road, Beijing 100853, China.'}, {'ForeName': 'Yanchun', 'Initials': 'Y', 'LastName': 'Luo', 'Affiliation': 'Department of Interventional Ultrasound, Chinese PLA General Hospital, 28 Fuxing Road, Beijing 100853, China.'}, {'ForeName': 'Xiang', 'Initials': 'X', 'LastName': 'Jing', 'Affiliation': 'Department of Ultrasound, Tianjin Third Central Hospital, Tianjin, China.'}, {'ForeName': 'Yilin', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': ""Department of Ultrasound Diagnosis, Tangdu Hospital, Fourth Military Medical University, Xi'an, China.""}, {'ForeName': 'Zhigang', 'Initials': 'Z', 'LastName': 'Cheng', 'Affiliation': 'Department of Interventional Ultrasound, Chinese PLA General Hospital, 28 Fuxing Road, Beijing 100853, China.'}, {'ForeName': 'Jinyu', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'Department of Ultrasound, Harbin The First Hospital, Harbin, China.'}, {'ForeName': 'Huiping', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': ""Department of Medical Ultrasound, Ma'anshan People's Hospital, Ma'anshan, China.""}, {'ForeName': 'Jintang', 'Initials': 'J', 'LastName': 'Liao', 'Affiliation': 'Department of Diagnostic Ultrasound, Xiangya Hospital, Changsha, China.'}, {'ForeName': 'Pei', 'Initials': 'P', 'LastName': 'Zhou', 'Affiliation': ""Department of Ultrasound, Central Theater Command General Hospital, Chinese People's Liberation Army, Wuhan, China.""}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Song', 'Affiliation': 'Department of Diagnostic Ultrasound, The Second Affiliated Hospital of Dalian Medical University, Dalian, China.'}, {'ForeName': 'Yao', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Ultrasound, Beijing Ditan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Zhiyu', 'Initials': 'Z', 'LastName': 'Han', 'Affiliation': 'Department of Interventional Ultrasound, Chinese PLA General Hospital, 28 Fuxing Road, Beijing 100853, China.'}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Cheng', 'Affiliation': 'Department of Ultrasound, Harbin Medical University Cancer Hospital, Harbin, China.'}, {'ForeName': 'Lina', 'Initials': 'L', 'LastName': 'Tang', 'Affiliation': 'Department of Ultrasound, Fujian Cancer Hospital&Fujian Medical University Cancer Hospita, Fuzhou, China.'}, {'ForeName': 'Fangyi', 'Initials': 'F', 'LastName': 'Liu', 'Affiliation': 'Department of Interventional Ultrasound, Chinese PLA General Hospital, 28 Fuxing Road, Beijing 100853, China.'}, {'ForeName': 'Jianping', 'Initials': 'J', 'LastName': 'Dou', 'Affiliation': 'Department of Interventional Ultrasound, Chinese PLA General Hospital, 28 Fuxing Road, Beijing 100853, China.'}, {'ForeName': 'Rongqin', 'Initials': 'R', 'LastName': 'Zheng', 'Affiliation': 'Guangdong Key Laboratory of Liver Disease Research, Department of Medical Ultrasound, The Third Affiliated Hospital of Sun Yat-sen University, Guangzhou, China. Electronic address: zhengrq@mail.sysu.edu.cn.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Yu', 'Affiliation': 'Department of Interventional Ultrasound, Chinese PLA General Hospital, 28 Fuxing Road, Beijing 100853, China. Electronic address: jiemi301@163.com.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Tian', 'Affiliation': 'Key Laboratory of Molecular Imaging, Institute of Automation, Chinese Academy of Sciences, Beijing, China; University of Chinese Academy of Sciences, Beijing, China; Beijing Advanced Innovation Center for Big Data-Based Precision Medicine, School of Medicine, Beihang University, Beijing, China. Electronic address: jie.tian@ia.ac.cn.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Liang', 'Affiliation': 'Department of Interventional Ultrasound, Chinese PLA General Hospital, 28 Fuxing Road, Beijing 100853, China. Electronic address: liangping301@hotmail.com.'}]",EBioMedicine,['10.1016/j.ebiom.2020.102777'] 2111,32585354,The benefits and costs of changing treatment technique in electroconvulsive therapy due to insufficient improvement of a major depressive episode.,"BACKGROUND Electroconvulsive therapy (ECT) technique is often changed after insufficient improvement, yet there has been little research on switching strategies. OBJECTIVE To document clinical outcome in ECT nonresponders who were received a second course using high dose, brief pulse, bifrontotemporal (HD BP BL) ECT, and compare relapse rates and cognitive effects relative to patients who received only one ECT course and as a function of the type of ECT first received. METHODS Patients were classified as receiving Weak, Strong, or HD BP BL ECT during three randomized trials at Columbia University. Nonresponders received HD BP BL ECT. In a separate multi-site trial, Optimization of ECT, patients were randomized to right unilateral or BL ECT and nonresponders also received further treatment with HD BP BL ECT. RESULTS Remission rates with a second course of HD BP BL ECT were high in ECT nonresponders, approximately 60% and 40% in the Columbia University and Optimization of ECT studies, respectively. Clinical outcome was independent of the type of ECT first received. A second course with HD BP BL ECT resulted in greater retrograde amnesia immediately, two months, and six months following ECT. CONCLUSIONS In the largest samples of ECT nonresponders studied to date, a second course of ECT had marked antidepressant effects. Since the therapeutic effects were independent of the technique first administered, it is possible that many patients may benefit simply from longer courses of ECT. Randomized trials are needed to determine whether, when, and how to change treatment technique in ECT.",2020,Clinical outcome was independent of the type of ECT first received.,"['Patients were classified as receiving Weak, Strong, or HD BP BL ECT during three randomized trials at Columbia University', 'patients who received only one ECT course and as a function of the type of ECT first received']","['Electroconvulsive therapy (ECT) technique', 'right unilateral or BL ECT', 'Electroconvulsive Therapy', 'HD BP BL ECT']","['retrograde amnesia', 'HD BP BL ECT']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C1762617', 'cui_str': 'Weak'}, {'cui': 'C0442821', 'cui_str': 'Strong'}, {'cui': 'C0013806', 'cui_str': 'Electroconvulsive therapy'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0013806', 'cui_str': 'Electroconvulsive therapy'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}]","[{'cui': 'C0002624', 'cui_str': 'Retrograde amnesia'}, {'cui': 'C0013806', 'cui_str': 'Electroconvulsive therapy'}]",,0.0665526,Clinical outcome was independent of the type of ECT first received.,"[{'ForeName': 'Harold A', 'Initials': 'HA', 'LastName': 'Sackeim', 'Affiliation': 'Department of Psychiatry, Columbia University, NY, USA; Department of Radiology, Columbia University, NY, USA. Electronic address: has1@columbia.edu.'}, {'ForeName': 'Joan', 'Initials': 'J', 'LastName': 'Prudic', 'Affiliation': 'Department of Psychiatry, Columbia University, NY, USA; New York State Psychiatric Institute, NY, USA.'}, {'ForeName': 'D P', 'Initials': 'DP', 'LastName': 'Devanand', 'Affiliation': 'Department of Psychiatry, Columbia University, NY, USA; New York State Psychiatric Institute, NY, USA; Department of Neurology, Columbia University, NY, USA.'}, {'ForeName': 'Mitchell S', 'Initials': 'MS', 'LastName': 'Nobler', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, New York Medical College, NY, USA.'}, {'ForeName': 'Roger F', 'Initials': 'RF', 'LastName': 'Haskett', 'Affiliation': 'Department of Psychiatry, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Benoit H', 'Initials': 'BH', 'LastName': 'Mulsant', 'Affiliation': 'Department of Psychiatry, University of Toronto, Toronto, ON, Canada; Centre for Addiction and Mental Health, Toronto, ON, Canada.'}, {'ForeName': 'Peter B', 'Initials': 'PB', 'LastName': 'Rosenquist', 'Affiliation': 'Department of Psychiatry and Health Behavior, Medical College of Georgia, Augusta University, Augusta, GA, USA.'}, {'ForeName': 'William V', 'Initials': 'WV', 'LastName': 'McCall', 'Affiliation': 'Department of Psychiatry and Health Behavior, Medical College of Georgia, Augusta University, Augusta, GA, USA.'}]",Brain stimulation,['10.1016/j.brs.2020.06.016'] 2112,32585438,Effect of in-bed cycling on acute muscle wasting in critically ill adults: A randomised clinical trial.,"PURPOSE To examine whether in-bed cycling assists critically ill adults to reduce acute muscle wasting, improve function and improve quality of life following a period of critical illness. MATERIALS AND METHODS A single-centre, two-group, randomised controlled trial with blinded assessment of the primary outcome was conducted in a tertiary ICU. Critically ill patients expected to be mechanically ventilated for at least 48 h were randomised to 30 min daily in-bed cycling in addition to usual-care physiotherapy (n = 37) or usual-care physiotherapy (n = 37). The primary outcome was muscle atrophy of rectus femoris cross-sectional area (RF CSA ) measured by ultrasound at Day 10 following study enrolment. Secondary outcomes included manual muscle strength, handgrip strength, ICU mobility score, six-minute walk test distance and health-related quality of life up to six-months following hospital admission. RESULTS Analysis included the 72 participants (mean age, 56-years; male, 68%) who completed the study. There were no significant between-group differences in muscle atrophy of RF CSA at Day 10 (mean difference 3.4, 95% CI -6.9% to 13.6%; p = .52), or for secondary outcomes (p-values ranged p = .11 to p = .95). CONCLUSIONS AND RELEVANCE In-bed cycling did not reduce muscle wasting in critically ill adults, but this study provides useful effect estimates for large-scale clinical trials. TRIAL REGISTRATION anzctr.org.au Identifier: ACTRN12616000948493.",2020,"There were no significant between-group differences in muscle atrophy of RF CSA at Day 10 (mean difference 3.4, 95% CI -6.9% to 13.6%; p = .52), or for secondary outcomes (p-values ranged p = .11 to p = .95). ","['72 participants (mean age, 56-years; male, 68%) who completed the study', 'critically ill adults', 'Critically ill patients expected to be mechanically ventilated for at least 48\xa0h']","['anzctr.org.au Identifier', '30\xa0min daily in-bed cycling in addition to usual-care physiotherapy (n\xa0=\xa037) or usual-care physiotherapy', 'bed cycling']","['quality of life', 'manual muscle strength, handgrip strength, ICU mobility score, six-minute walk test distance and health-related quality of life up to six-months following hospital admission', 'muscle atrophy of rectus femoris cross-sectional area (RF CSA ', 'muscle atrophy of RF CSA']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0042491', 'cui_str': 'Ventilation'}]","[{'cui': 'C0600091', 'cui_str': 'Identifier'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0004914', 'cui_str': 'Bedding'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0026846', 'cui_str': 'Muscle atrophy'}, {'cui': 'C0010362', 'cui_str': 'Cross Sectional Analysis'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0584894', 'cui_str': 'Rectus femoris muscle structure'}]",,0.450536,"There were no significant between-group differences in muscle atrophy of RF CSA at Day 10 (mean difference 3.4, 95% CI -6.9% to 13.6%; p = .52), or for secondary outcomes (p-values ranged p = .11 to p = .95). ","[{'ForeName': 'Marc R', 'Initials': 'MR', 'LastName': 'Nickels', 'Affiliation': 'Physiotherapy Department, Princess Alexandra Hospital, Metro South Health, Brisbane, Queensland, Australia; Australian Centre for Health Services Innovation for Healthcare Transformation, School of Public Health & Social Work, Queensland University of Technology, Brisbane, Queensland, Australia; Centre for Functioning and Health Research, Metro South Health, Brisbane, Queensland, Australia; Intensive Care Unit, Princess Alexandra Hospital, Metro South Health, Brisbane, Queensland, Australia. Electronic address: marc.nickels@health.qld.gov.au.'}, {'ForeName': 'Leanne M', 'Initials': 'LM', 'LastName': 'Aitken', 'Affiliation': 'School of Health Sciences, City, University of London, London, United Kingdom; Menzies Health Institute Queensland, Griffith University, Brisbane, Queensland, Australia. Electronic address: leanne.aitken.1@city.ac.uk.'}, {'ForeName': 'Adrian G', 'Initials': 'AG', 'LastName': 'Barnett', 'Affiliation': 'Australian Centre for Health Services Innovation for Healthcare Transformation, School of Public Health & Social Work, Queensland University of Technology, Brisbane, Queensland, Australia. Electronic address: a.barnett@qut.edu.au.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Walsham', 'Affiliation': 'Intensive Care Unit, Princess Alexandra Hospital, Metro South Health, Brisbane, Queensland, Australia; School of Medicine, University of Queensland, Brisbane, Queensland, Australia. Electronic address: james.walsham@health.qld.gov.au.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'King', 'Affiliation': 'Department of Radiology, Princess Alexandra Hospital, Metro South Health, Brisbane, Queensland, Australia. Electronic address: scott.king@health.qld.gov.au.'}, {'ForeName': 'Nicolette E', 'Initials': 'NE', 'LastName': 'Gale', 'Affiliation': 'Department of Radiology, Princess Alexandra Hospital, Metro South Health, Brisbane, Queensland, Australia. Electronic address: nicolette.gale@health.qld.gov.au.'}, {'ForeName': 'Alicia C', 'Initials': 'AC', 'LastName': 'Bowen', 'Affiliation': 'Physiotherapy Department, Princess Alexandra Hospital, Metro South Health, Brisbane, Queensland, Australia; Intensive Care Unit, Princess Alexandra Hospital, Metro South Health, Brisbane, Queensland, Australia. Electronic address: alicia.bowen@health.qld.gov.au.'}, {'ForeName': 'Brent M', 'Initials': 'BM', 'LastName': 'Peel', 'Affiliation': 'Physiotherapy Department, Princess Alexandra Hospital, Metro South Health, Brisbane, Queensland, Australia; Intensive Care Unit, Princess Alexandra Hospital, Metro South Health, Brisbane, Queensland, Australia. Electronic address: brent.peel@health.qld.gov.au.'}, {'ForeName': 'Samuel L', 'Initials': 'SL', 'LastName': 'Donaldson', 'Affiliation': 'Physiotherapy Department, Princess Alexandra Hospital, Metro South Health, Brisbane, Queensland, Australia; Intensive Care Unit, Princess Alexandra Hospital, Metro South Health, Brisbane, Queensland, Australia. Electronic address: samuel.donaldson2@health.qld.gov.au.'}, {'ForeName': 'Stewart T J', 'Initials': 'STJ', 'LastName': 'Mealing', 'Affiliation': 'Intensive Care Unit, Princess Alexandra Hospital, Metro South Health, Brisbane, Queensland, Australia. Electronic address: stewart.mealing@health.qld.gov.au.'}, {'ForeName': 'Steven M', 'Initials': 'SM', 'LastName': 'McPhail', 'Affiliation': 'Australian Centre for Health Services Innovation for Healthcare Transformation, School of Public Health & Social Work, Queensland University of Technology, Brisbane, Queensland, Australia; Centre for Functioning and Health Research, Metro South Health, Brisbane, Queensland, Australia; Clinical Informatics, Metro South Health, Brisbane, Australia. Electronic address: steven.mcphail@qut.edu.au.'}]",Journal of critical care,['10.1016/j.jcrc.2020.05.008'] 2113,32586526,Variants in ADRB1 and CYP2C9: Association with Response to Atenolol and Losartan in Marfan Syndrome.,"OBJECTIVE To test whether variants in ADRB1 and CYP2C9 genes identify subgroups of individuals with differential response to treatment for Marfan syndrome through analysis of data from a large, randomized trial. STUDY DESIGN In a subset of 250 white, non-Hispanic participants with Marfan syndrome in a prior randomized trial of atenolol vs losartan, the common variants rs1801252 and rs1801253 in ADRB1 and rs1799853 and rs1057910 in CYP2C9 were analyzed. The primary outcome was baseline-adjusted annual rate of change in the maximum aortic root diameter z-score over 3 years, assessed using mixed effects models. RESULTS Among 122 atenolol-assigned participants, the 70 with rs1801253 CC genotype had greater rate of improvement in aortic root z-score compared with 52 participants with CG or GG genotypes (Time × Genotype interaction P = .005, mean annual z-score change ± SE -0.20 ± 0.03 vs -0.09 ± 0.03). Among participants with the CC genotype in both treatment arms, those assigned to atenolol had greater rate of improvement compared with the 71 of the 121 assigned to losartan (interaction P = .002; -0.20 ± 0.02 vs -0.07 ± 0.02; P < .001). There were no differences in atenolol response by rs1801252 genotype or in losartan response by CYP2C9 metabolizer status. CONCLUSIONS In this exploratory study, ADRB1-rs1801253 was associated with atenolol response in children and young adults with Marfan syndrome. If these findings are confirmed in future studies, ADRB1 genotyping has the potential to guide therapy by identifying those who are likely to have greater therapeutic response to atenolol than losartan.",2020,"There were no differences in atenolol response by rs1801252 genotype or in losartan response by CYP2C9 metabolizer status. ","['250 white, non-Hispanic participants with Marfan syndrome', 'Marfan Syndrome', 'children and young adults with Marfan syndrome']","['atenolol vs losartan', 'losartan', 'Atenolol and Losartan', 'atenolol']","['atenolol response', 'rate of improvement in aortic root z-score', 'rate of improvement', 'baseline-adjusted annual rate of change in the maximum aortic root diameter z-score over 3\xa0years, assessed using mixed effects models']","[{'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0024796', 'cui_str': ""Marfan's syndrome""}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C0004147', 'cui_str': 'Atenolol'}, {'cui': 'C0126174', 'cui_str': 'Losartan'}]","[{'cui': 'C0004147', 'cui_str': 'Atenolol'}, {'cui': 'C0549113', 'cui_str': 'Supraaortic valve area structure'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}]",52.0,0.139844,"There were no differences in atenolol response by rs1801252 genotype or in losartan response by CYP2C9 metabolizer status. ","[{'ForeName': 'Sara L', 'Initials': 'SL', 'LastName': 'Van Driest', 'Affiliation': 'Department of Pediatrics, Vanderbilt University Medical Center, Nashville, TN; Department of Medicine, Vanderbilt University Medical Center, Nashville, TN.'}, {'ForeName': 'Lynn A', 'Initials': 'LA', 'LastName': 'Sleeper', 'Affiliation': ""Department of Cardiology, Boston Children's Hospital, and Department of Pediatrics, Harvard Medical School, Boston, MA.""}, {'ForeName': 'Bruce D', 'Initials': 'BD', 'LastName': 'Gelb', 'Affiliation': 'Mindich Child Health and Development Institute, Departments of Pediatrics and Genetics & Genomic Sciences, Icahn School of Medicine at Mount Sinai, New York, NY.'}, {'ForeName': 'Shaine A', 'Initials': 'SA', 'LastName': 'Morris', 'Affiliation': ""Division of Cardiology, Department of Pediatrics, Baylor College of Medicine and Texas Children's Hospital, Houston, TX.""}, {'ForeName': 'Harry C', 'Initials': 'HC', 'LastName': 'Dietz', 'Affiliation': 'Institute of Genetic Medicine, Johns Hopkins University School of Medicine and Howard Hughes Medical Institute, Baltimore, MD.'}, {'ForeName': 'Geoffrey A', 'Initials': 'GA', 'LastName': 'Forbus', 'Affiliation': 'Department of Pediatrics, Division of Pediatric Cardiology, Medical University of South Carolina, Charleston, SC.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Goldmuntz', 'Affiliation': ""Division of Cardiology, Children's Hospital of Philadelphia, Department of Pediatrics University of Pennsylvania Perlman School of Medicine, Philadelphia, PA.""}, {'ForeName': 'Arvind', 'Initials': 'A', 'LastName': 'Hoskoppal', 'Affiliation': 'Departments of Pediatrics and Internal Medicine, University of Utah and Intermountain Healthcare, Salt Lake City, UT.'}, {'ForeName': 'Jeanne', 'Initials': 'J', 'LastName': 'James', 'Affiliation': ""Department of Pediatrics, Section of Cardiology, Medical College of Wisconsin and Children's Hospital of Wisconsin, Milwaukee, WI.""}, {'ForeName': 'Teresa M', 'Initials': 'TM', 'LastName': 'Lee', 'Affiliation': 'Department of Pediatrics, Columbia University Medical Center, New York, NY.'}, {'ForeName': 'Jami C', 'Initials': 'JC', 'LastName': 'Levine', 'Affiliation': ""Department of Cardiology, Boston Children's Hospital, and Department of Pediatrics, Harvard Medical School, Boston, MA.""}, {'ForeName': 'Jennifer S', 'Initials': 'JS', 'LastName': 'Li', 'Affiliation': 'Department of Pediatrics, Division of Cardiology, Duke University Medical Center, Durham, NC.'}, {'ForeName': 'Bart L', 'Initials': 'BL', 'LastName': 'Loeys', 'Affiliation': 'Center of Medical Genetics, Faculty of Medicine and Health Sciences, University of Antwerp and Antwerp University Hospital, Antwerp, Belgium.'}, {'ForeName': 'Larry W', 'Initials': 'LW', 'LastName': 'Markham', 'Affiliation': 'Department of Pediatrics, Division of Pediatric Cardiology, Riley Hospital for Children, Indiana University School of Medicine, Indianapolis, IN.'}, {'ForeName': 'Josephina A N', 'Initials': 'JAN', 'LastName': 'Meester', 'Affiliation': 'Center of Medical Genetics, Faculty of Medicine and Health Sciences, University of Antwerp and Antwerp University Hospital, Antwerp, Belgium.'}, {'ForeName': 'Seema', 'Initials': 'S', 'LastName': 'Mital', 'Affiliation': 'Department of Pediatrics, Division of Cardiology, Hospital for Sick Children, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Jonathan D', 'Initials': 'JD', 'LastName': 'Mosley', 'Affiliation': 'Department of Medicine, Vanderbilt University Medical Center, Nashville, TN.'}, {'ForeName': 'Aaron K', 'Initials': 'AK', 'LastName': 'Olson', 'Affiliation': ""Department of Pediatrics, Seattle Children's Hospital, Seattle, WA.""}, {'ForeName': 'Marjolijn', 'Initials': 'M', 'LastName': 'Renard', 'Affiliation': 'Center for Medical Genetics, Faculty of Medicine and Health Sciences, Ghent University, Ghent, Belgium.'}, {'ForeName': 'Christian M', 'Initials': 'CM', 'LastName': 'Shaffer', 'Affiliation': 'Department of Medicine, Vanderbilt University Medical Center, Nashville, TN.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Sharkey', 'Affiliation': 'Department of Pediatrics, Washington University, St. Louis, MO.'}, {'ForeName': 'Luciana', 'Initials': 'L', 'LastName': 'Young', 'Affiliation': ""Department of Pediatrics, Ann & Robert H. Lurie Children's Hospital, Chicago, IL.""}, {'ForeName': 'Ronald V', 'Initials': 'RV', 'LastName': 'Lacro', 'Affiliation': ""Department of Cardiology, Boston Children's Hospital, and Department of Pediatrics, Harvard Medical School, Boston, MA.""}, {'ForeName': 'Dan M', 'Initials': 'DM', 'LastName': 'Roden', 'Affiliation': 'Department of Medicine, Vanderbilt University Medical Center, Nashville, TN; Departments of Pharmacology and Biomedical Informatics, Vanderbilt University Medical Center, Nashville, TN.'}]",The Journal of pediatrics,['10.1016/j.jpeds.2020.03.064'] 2114,32586939,Clinical significance of circulating tumor cells in hormone receptor-positive metastatic breast cancer patients who received letrozole with or without bevacizumab.,"PURPOSE We evaluated the prognostic and predictive value of circulating tumor cells (CTCs) hormone-receptor positive (HR+) metastatic breast cancer (MBC) patients randomized to letrozole (Let) alone or letrozole plus bevacizumab (Let+Bev) in the first-line setting (CALGB 40503). EXPERIMENTAL DESIGN Blood samples were collected at pretreatment and three additional time points during therapy. The presence of ≥5 CTCs per 7.5 mLs of blood was considered CTC-positive. Association of CTCs with progression-free survival (PFS) and overall survival (OS) was assessed using Cox regression models. RESULTS Of 343 patients treated, 294 had CTC data and were included in this analysis. Median follow-up was 39 months. In multivariable analysis, CTC-positive patients at baseline (31%) had significantly reduced PFS (HR=1.49; 95%CI: 1.12-1.97) and OS (HR=2.08; 95%CI: 1.49-2.93) compared to CTC-negative. Failure to clear CTCs during treatment was associated with significantly increased risk of progression (HR=2.2; 95%CI: 1.58-3.07) and death (HR=3.4; 95% CI: 2.36-4.88). CTC-positive patients who received only Let had the worse PFS (HR=2.3; 95% CI: 1.54-3.47) and OS (HR=2.6; 95% CI: 1.59-4.40). Median PFS in CTC-positive patients was significantly longer (18.0 versus 7.0 months) in Let+Bev versus Let arm (p=0.0009). Restricted mean survival time analysis further revealed that addition of Bev was associated with PFS benefit in both CTC-positive and CTC-negative patients, but OS benefit was only observed in CTC-positive patients. CONCLUSIONS CTCs were highly prognostic for the addition of Bev to first-line Let in patients with HR+ MBC. Further research to determine the potential predictive value of CTCs in this setting is warranted.",2020,only Let had the worse PFS (HR=2.3; 95% CI: 1.54-3.47) and OS (HR=2.6; 95% CI: 1.59-4.40).,"['hormone receptor-positive metastatic breast cancer patients who received', 'CTC-positive patients who received', '343 patients treated, 294 had CTC data and were included in this analysis', 'patients with HR+ MBC']","['letrozole with or without bevacizumab', 'letrozole (Let) alone or letrozole plus bevacizumab (Let+Bev']","['OS benefit', 'Median PFS', 'PFS', 'death', 'Association of CTCs with progression-free survival (PFS) and overall survival (OS', 'risk of progression', 'worse PFS']","[{'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0278488', 'cui_str': 'Breast cancer stage IV'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027625', 'cui_str': 'Circulating Neoplastic Cells'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0246421', 'cui_str': 'letrozole'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0027625', 'cui_str': 'Circulating Neoplastic Cells'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}]",,0.146634,only Let had the worse PFS (HR=2.3; 95% CI: 1.54-3.47) and OS (HR=2.6; 95% CI: 1.59-4.40).,"[{'ForeName': 'Mark Jesus M', 'Initials': 'MJM', 'LastName': 'Magbanua', 'Affiliation': 'Laboratory Medicine, University of California, San Francisco Mark.Magbanua@ucsf.edu.'}, {'ForeName': 'Oleksander', 'Initials': 'O', 'LastName': 'Savenkov', 'Affiliation': 'Department of Biostatistics and Epidemiology, Weill Cornell Medicine.'}, {'ForeName': 'Erik J', 'Initials': 'EJ', 'LastName': 'Asmus', 'Affiliation': 'Health Sciences Research, Mayo Clinic.'}, {'ForeName': 'Karla', 'Initials': 'K', 'LastName': 'Ballman', 'Affiliation': 'Population Health Sciences, Weill Cornell Medicine.'}, {'ForeName': 'Janet H', 'Initials': 'JH', 'LastName': 'Scott', 'Affiliation': 'Hematology Oncology, University of California, San Francisco.'}, {'ForeName': 'John W', 'Initials': 'JW', 'LastName': 'Park', 'Affiliation': 'Hematology/Oncology, University of California, San Francisco.'}, {'ForeName': 'Maura', 'Initials': 'M', 'LastName': 'Dickler', 'Affiliation': 'Eli Lilly.'}, {'ForeName': 'Ann H', 'Initials': 'AH', 'LastName': 'Partridge', 'Affiliation': 'Harvard Medical School.'}, {'ForeName': 'Lisa A', 'Initials': 'LA', 'LastName': 'Carey', 'Affiliation': 'Medicine, University of North Carolina School of Medicine.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Winer', 'Affiliation': 'Dana Farber Harvard Cancer Center.'}, {'ForeName': 'Hope S', 'Initials': 'HS', 'LastName': 'Rugo', 'Affiliation': 'Helen Diller Family Comprehensive Cancer Center, University of California, San Francisco.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-20-1329'] 2115,32587397,The effect of 17% EDTA and QMiX ultrasonic activation on smear layer removal and sealer penetration: ex vivo study.,"This study aimed to compare the effect of conventional irrigation (CI) and passive ultrasonic irrigation (PUI) with 17% EDTA and QMiX on the maximum depth and percentage of sealer penetration into the dentinal tubules by confocal laser scanning microscopy (CLSM) and to describe the cleaning of root canal walls by scanning electron microscopy (SEM). Eighty single-rooted human mandibular premolars were instrumented and randomly assigned to four groups (n = 20): EDTA + CI, QMiX + CI, EDTA + PUI, and QMiX + PUI. Ten samples from each group were examined by SEM (2,000×) and the remaining 40 roots were filled with a single gutta-percha cone and AH Plus sealer mixed with 0.1% rhodamine B for analysis by CLSM (10×). Images were assessed at distances of 2 mm (apical), 5 mm (middle), and 8 mm (coronal) from the apex with the Leica Application Suite V4.10 software. The EDTA + PUI and QMiX + PUI protocols presented higher rates of debris/smear layer removal in the apical and middle thirds. The PUI was superior to CI in the maximum depth of sealer penetration at the middle third. The QMiX + PUI group had a higher percentage of sealer penetration at the apical third. The PUI and QMiX protocol improved debris/smear layer removal and tubular dentin sealer penetration.",2020,The PUI and QMiX protocol improved debris/smear layer removal and tubular dentin sealer penetration.,"['Ten samples from each group were examined by SEM (2,000×) and the remaining 40 roots were filled with a', 'Eighty single-rooted human mandibular premolars']","['conventional irrigation (CI) and passive ultrasonic irrigation (PUI) with 17% EDTA and QMiX', '17% EDTA and QMiX ultrasonic activation', 'single gutta-percha cone and AH Plus sealer mixed with 0.1% rhodamine B for analysis by CLSM']","['sealer penetration', 'rates of debris/smear layer removal', 'debris/smear layer removal and tubular dentin sealer penetration']","[{'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332128', 'cui_str': 'Examined for'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0026019', 'cui_str': 'Electron microscopic study'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C1704302', 'cui_str': 'Structure of premolar tooth'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0022100', 'cui_str': 'Irrigation'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0013618', 'cui_str': 'Edetic Acid'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0440200', 'cui_str': 'Gutta percha cone'}, {'cui': 'C0673096', 'cui_str': 'AH Plus'}, {'cui': 'C0449942', 'cui_str': 'Sealer'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C4517420', 'cui_str': '0.1'}, {'cui': 'C0073194', 'cui_str': 'Rhodamine B'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0242841', 'cui_str': 'Confocal Laser Scanning Microscopy'}]","[{'cui': 'C0449942', 'cui_str': 'Sealer'}, {'cui': 'C0205321', 'cui_str': 'Penetrating'}, {'cui': 'C0440266', 'cui_str': 'Debris'}, {'cui': 'C0085070', 'cui_str': 'Smear Layer'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0332208', 'cui_str': 'Tubular'}, {'cui': 'C0011429', 'cui_str': 'Dentin structure'}]",80.0,0.0357585,The PUI and QMiX protocol improved debris/smear layer removal and tubular dentin sealer penetration.,"[{'ForeName': 'Felipe de Souza', 'Initials': 'FS', 'LastName': 'Matos', 'Affiliation': 'Postgraduate Program in Dentistry, School of Dentistry, Federal University of Uberlândia (UFU), Uberlândia, MG, Brazil. felipe_smatos@hotmail.com.'}, {'ForeName': 'Fabrício Rutz', 'Initials': 'FR', 'LastName': 'da Silva', 'Affiliation': 'Department of Restorative Dentistry, School of Dentistry, State University of Ponta Grossa (UEPG), Ponta Grossa, PR, Brazil.'}, {'ForeName': 'Luiz Renato', 'Initials': 'LR', 'LastName': 'Paranhos', 'Affiliation': 'Department of Preventive and Social Dentistry, School of Dentistry, Federal University of Uberlândia (UFU), Uberlândia, MG, Brazil.'}, {'ForeName': 'Camilla Christian Gomes', 'Initials': 'CCG', 'LastName': 'Moura', 'Affiliation': 'Department of Endodontics, School of Dentistry, Federal University of Uberlândia (UFU), Uberlândia, MG, Brazil.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Bresciani', 'Affiliation': 'Department of Restorative Dentistry, Institute of Science and Technology, São Paulo State University (Unesp), São José dos Campos, SP, Brazil.'}, {'ForeName': 'Marcia Carneiro', 'Initials': 'MC', 'LastName': 'Valera', 'Affiliation': 'Department of Restorative Dentistry, Institute of Science and Technology, São Paulo State University (Unesp), São José dos Campos, SP, Brazil.'}]",Scientific reports,['10.1038/s41598-020-67303-z'] 2116,32589153,Evaluation of the Tobbstop Mobile App for Smoking Cessation: Cluster Randomized Controlled Clinical Trial.,"BACKGROUND Mobile apps provide an accessible way to test new health-related methodologies. Tobacco is still the primary preventable cause of death in industrialized countries, constituting an important public health issue. New technologies provide novel opportunities that are effective in the cessation of smoking tobacco. OBJECTIVE This paper aims to evaluate the efficacy and usage of a mobile app for assisting adult smokers to quit smoking. METHODS We conducted a cluster randomized clinical trial. We included smokers older than 18 years who were motivated to stop smoking and used a mobile phone compatible with our mobile app. We carried out follow-up visits at 15, 30, and 45 days, and at 2, 3, 6, and 12 months. Participants of the intervention group had access to the Tobbstop mobile app designed by the research team. The primary outcomes were continuous smoking abstinence at 3 and 12 months. RESULTS A total of 773 participants were included in the trial, of which 602 (77.9%) began the study on their D-Day. Of participants in the intervention group, 34.15% (97/284) did not use the app. The continuous abstention level was significantly larger in the intervention group participants who used the app than in those who did not use the app at both 3 months (72/187, 38.5% vs 13/97, 13.4%; P<.001) and 12 months (39/187, 20.9% vs 8/97, 8.25%; P=.01). Participants in the intervention group who used the app regularly and correctly had a higher probability of not being smokers at 12 months (OR 7.20, 95% CI 2.14-24.20; P=.001) than the participants of the CG. CONCLUSIONS Regular use of an app for smoking cessation is effective in comparison with standard clinical practice. TRIAL REGISTRATION Clinicaltrials.gov NCT01734421; https://clinicaltrials.gov/ct2/show/NCT01734421.",2020,"The continuous abstention level was significantly larger in the intervention group participants who used the app than in those who did not use the app at both 3 months (72/187, 38.5% vs 13/97, 13.4%; P<.001) and 12 months (39/187, 20.9% vs 8/97, 8.25%; P=.01).","['A total of 773 participants were included in the trial, of which 602 (77.9%) began the study on their D-Day', 'smokers older than 18 years who were motivated to stop smoking and used a mobile phone compatible with our mobile app']",[],"['higher probability of not being smokers', 'continuous smoking abstinence', 'continuous abstention level']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439228', 'cui_str': 'day'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0425310', 'cui_str': 'Stopped smoking'}, {'cui': 'C1136360', 'cui_str': 'Car Phone'}, {'cui': 'C0332290', 'cui_str': 'Consistent with'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}]",[],"[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",773.0,0.193476,"The continuous abstention level was significantly larger in the intervention group participants who used the app than in those who did not use the app at both 3 months (72/187, 38.5% vs 13/97, 13.4%; P<.001) and 12 months (39/187, 20.9% vs 8/97, 8.25%; P=.01).","[{'ForeName': 'Meritxell', 'Initials': 'M', 'LastName': 'Pallejà-Millán', 'Affiliation': ""Unitat de Suport a la Recerca Camp de Tarragona, Fundació Institut Universitari per a la recerca a l'Atenció Primària de Salut Jordi Gol i Gurina, Reus, Spain.""}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Rey-Reñones', 'Affiliation': 'Departament de Ciències Mèdiques Bàsiques, Universitat Rovira i Virgili, Reus, Spain.'}, {'ForeName': 'Maria Luisa', 'Initials': 'ML', 'LastName': 'Barrera Uriarte', 'Affiliation': 'Institut Català de la Salut, Unitat de Suport a la Recerca Camp de Tarragona, Reus, Spain.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Granado-Font', 'Affiliation': 'Institut Català de la Salut, Unitat de Suport a la Recerca Camp de Tarragona, Reus, Spain.'}, {'ForeName': 'Josep', 'Initials': 'J', 'LastName': 'Basora', 'Affiliation': ""Unitat de Suport a la Recerca Camp de Tarragona, Fundació Institut Universitari per a la recerca a l'Atenció Primària de Salut Jordi Gol i Gurina, Reus, Spain.""}, {'ForeName': 'Gemma', 'Initials': 'G', 'LastName': 'Flores-Mateo', 'Affiliation': ""Unitat de Suport a la Recerca Camp de Tarragona, Fundació Institut Universitari per a la recerca a l'Atenció Primària de Salut Jordi Gol i Gurina, Reus, Spain.""}, {'ForeName': 'Jordi', 'Initials': 'J', 'LastName': 'Duch', 'Affiliation': ""Departament d'Enginyeria Informàtica i Matemàtiques, Universitat Rovira i Virgili, Tarragona, Spain.""}]",JMIR mHealth and uHealth,['10.2196/15951'] 2117,32589155,Improving the Lifestyle of Adolescents Through Peer Education and Support in Vietnam: Protocol for a Pilot Cluster Randomized Controlled Trial.,"BACKGROUND In Ho Chi Minh City, Vietnam, recent studies found a rapid increase in overweight and obesity in adolescents. There is a need for effective health promotion interventions to support healthy diets and encourage a physically active lifestyle. This study will help fill an evidence gap on effective interventions to prevent excess weight gain in adolescents and generate new insights about peer-led education to promote healthy lifestyles. OBJECTIVE We aim to assess the feasibility and acceptability of a combined peer-led and peer support intervention among junior high school students in Ho Chi Minh City. Additionally, the efficacy of the intervention on adolescents' dietary practices and time spent on physical activity will also be measured in this pilot study. METHODS The Peer Education and Peer Support (PEPS) project is a pilot cluster randomized controlled trial with 2 intervention and 2 control schools. The intervention consists of 4 weekly education sessions of why and how to choose healthy food and drinks and how to be more physically active. Additionally, the intervention includes a school-based and online support system to help maintain student engagement during the intervention. We will use in-depth interviews with students, peer leaders, teachers, and parents; focus group discussions with peer educators; and direct observation of the school environment and peer leaders' interactions with the students. Acceptability and feasibility of the intervention will be assessed. We will also quantitatively assess limited efficacy by measuring changes in student' physical activity levels and dietary behaviors. RESULTS We delivered the peer education intervention at the start of each school year over 3 months for all new grade 6 adolescents in the selected schools, followed by peer support and home engagement activities over 6 months until the end of the school year. There was a baseline assessment and 2 post-intervention assessments: the first immediately after the intervention to assess the short-term impact and the second at the end of the school year to assess the sustained impact on changes in adiposity, diet, and physical activity. CONCLUSIONS The findings of this study will be used to develop a larger-scale cluster randomized controlled trial to examine the impact of a multicomponent, school- and home-based health promotion intervention. The trial will use innovative peer education methods to reduce overweight and obesity and improve dietary choices and physical activity levels in Vietnamese adolescents. TRIAL REGISTRATION Australian New Zealand Clinical Trials Registry ACTRN12619000421134; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=376690&isReview=true. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID) DERR1-10.2196/15930.",2020,"OBJECTIVE We aim to assess the feasibility and acceptability of a combined peer-led and peer support intervention among junior high school students in Ho Chi Minh City.","['overweight and obesity in adolescents', 'Vietnamese adolescents', 'junior high school students in Ho Chi Minh City']","[""discussions with peer educators; and direct observation of the school environment and peer leaders' interactions with the students"", 'combined peer-led and peer support intervention', 'Peer Education and Peer Support', 'multicomponent, school- and home-based health promotion intervention', 'peer education intervention']","['feasibility and acceptability', 'changes in adiposity, diet, and physical activity', 'Acceptability and feasibility']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0042660', 'cui_str': 'Vietnamese language'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0376586', 'cui_str': 'Life-Breath (Philosophy)'}, {'cui': 'C0008848', 'cui_str': 'Cities'}]","[{'cui': 'C0557061', 'cui_str': 'Discussion'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018738', 'cui_str': 'Health promotion'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",,0.0860508,"OBJECTIVE We aim to assess the feasibility and acceptability of a combined peer-led and peer support intervention among junior high school students in Ho Chi Minh City.","[{'ForeName': 'Hong K', 'Initials': 'HK', 'LastName': 'Tang', 'Affiliation': 'Department of Epidemiology, Faculty of Public Health, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Ngoc-Minh', 'Initials': 'NM', 'LastName': 'Nguyen', 'Affiliation': 'Department of Epidemiology, Faculty of Public Health, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Dibley', 'Affiliation': 'The Sydney School of Public Health, Faculty of Medicine and Health, The University of Sydney, Sydney, Australia.'}, {'ForeName': 'Trang H H D', 'Initials': 'THHD', 'LastName': 'Nguyen', 'Affiliation': 'Department of Epidemiology, Faculty of Public Health, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Ashraful', 'Initials': 'A', 'LastName': 'Alam', 'Affiliation': 'The Sydney School of Public Health, Faculty of Medicine and Health, The University of Sydney, Sydney, Australia.'}]",JMIR research protocols,['10.2196/15930'] 2118,32589156,Interactive Guidance Intervention to Address Sustained Social Withdrawal in Preterm Infants in Chile: Protocol for a Randomized Controlled Trial.,"BACKGROUND Preterm newborns can be exposed early to significant perinatal stress, and this stress can increase the risk of altered socioemotional development. Sustained social withdrawal in infants is an early indicator of emotional distress which is expressed by low reactivity to the environment, and if persistent, is frequently associated with altered psychological development. Infants born prematurely have a higher probability of developing sustained social withdrawal (adjusted odds ratio 1.84, 95% CI 1.04-3.26) than infants born full term, and there is a correlation between weight at birth and sustained social withdrawal at 12 months of age. OBJECTIVE The aims of this study are to compare the effect of the interactive guidance intervention to that of routine pediatric care on sustained social withdrawal in infants born moderately or late preterm and to explore the relationship between sustained social withdrawal in these infants and factors such as neonatal intensive care unit hospitalization variables, parental depression, and posttraumatic stress symptoms. METHODS This study is designed as a multicenter randomized controlled trial. Moderate and late preterm newborns and their parents were recruited and randomized (1:1 allocation ratio) to control and experimental groups. During neonatal intensive care unit hospitalization, daily duration of skin-to-skin contact, breastfeeding, and parental visits were recorded. Also, a daily score for neonatal pain and painful invasive procedures were recorded. After discharge from neonatal intensive care, for the duration of the study, both groups will attend follow-up consultations with neonatologists at 2, 6, and 12 months of age (corrected for gestational age) and will receive routine pediatric care. Every consultation will be recorded and assessed with the Alarm Distress Baby Scale to detect sustained social withdrawal (indicated by a score of 5 or higher). The neonatologists will perform an interactive guidance intervention if an infant in the intervention group exhibits sustained social withdrawal. In each follow-up consultation, parents will fill out the Edinburgh Postnatal Depression Scale, the modified Perinatal Posttraumatic Stress Disorder Questionnaire, and the Impact of Event Scale-revised. RESULTS Recruitment for this trial started in September 2017. As of May 2020, we have completed enrollment (N=110 infants born moderately or late preterm). We aim to publish the results by mid-2021. CONCLUSIONS This is the first randomized controlled trial with a sample of infants born moderately or late preterm infants who will attend pediatric follow-up consultations during their first year (corrected for gestational age at birth) with neonatologists trained in the Alarm Distress Baby Scale and who will receive this interactive guidance intervention. If successful, this early intervention will show significant potential to be implemented in both public and private health care, given its low cost of training staff and that the intervention takes place during routine pediatric follow-up. TRIAL REGISTRATION ClinicalTrials.gov NCT03212547; https://clinicaltrials.gov/ct2/show/NCT03212547. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID) DERR1-10.2196/17943.",2020,"Infants born prematurely have a higher probability of developing sustained social withdrawal (adjusted odds ratio 1.84, 95% CI 1.04-3.26) than infants born full term, and there is a correlation between weight at birth and sustained social withdrawal at 12 months of age. ","['infants born moderately or late preterm', 'N=110 infants born moderately or late preterm', 'Moderate and late preterm newborns and their parents', 'infants born moderately or late preterm infants who will attend pediatric follow-up consultations during their first year (corrected for gestational age at birth) with neonatologists trained in the Alarm Distress Baby Scale and who will receive this', 'Preterm Infants in Chile', 'Preterm newborns']","['routine pediatric care', 'interactive guidance intervention', 'Interactive Guidance Intervention']","['higher probability of developing sustained social withdrawal', 'neonatal pain and painful invasive procedures', 'weight at birth and sustained social withdrawal', 'Edinburgh Postnatal Depression Scale, the modified Perinatal Posttraumatic Stress Disorder Questionnaire', 'daily duration of skin-to-skin contact, breastfeeding, and parental visits']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C3898619', 'cui_str': 'Late preterm infant'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0422322', 'cui_str': 'Follow-up consultation'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0456129', 'cui_str': 'Length of gestation at birth'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0008107', 'cui_str': 'Chile'}]","[{'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C3839839', 'cui_str': 'Pediatric care'}, {'cui': 'C0042934', 'cui_str': 'Vocational counseling'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0424095', 'cui_str': 'Social withdrawal'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C1744681', 'cui_str': 'Congenital'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C0451144', 'cui_str': 'Edinburgh postnatal depression scale'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0178795', 'cui_str': 'Perinatal period'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0030551', 'cui_str': 'Parent'}]",,0.149628,"Infants born prematurely have a higher probability of developing sustained social withdrawal (adjusted odds ratio 1.84, 95% CI 1.04-3.26) than infants born full term, and there is a correlation between weight at birth and sustained social withdrawal at 12 months of age. ","[{'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Bustamante Loyola', 'Affiliation': 'Neonatology Unit, Clinica Alemana de Santiago, Santiago, Chile.'}, {'ForeName': 'Marcela', 'Initials': 'M', 'LastName': 'Perez Retamal', 'Affiliation': 'Neonatology Unit, Clinica Alemana de Santiago, Santiago, Chile.'}, {'ForeName': 'Monica Isabel', 'Initials': 'MI', 'LastName': 'Morgues Nudman', 'Affiliation': 'Neonatology Unit, Hospital San Jose, Santiago, Chile.'}, {'ForeName': 'Andres', 'Initials': 'A', 'LastName': 'Maturana', 'Affiliation': 'Neonatology Unit, Clinica Alemana de Santiago, Santiago, Chile.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Salinas Gonzalez', 'Affiliation': 'Neonatology Unit, Clinica Alemana de Santiago, Santiago, Chile.'}, {'ForeName': 'Horacio', 'Initials': 'H', 'LastName': 'Cox', 'Affiliation': 'Neonatology Unit, Clinica Alemana de Santiago, Santiago, Chile.'}, {'ForeName': 'José Miguel', 'Initials': 'JM', 'LastName': 'González Mas', 'Affiliation': 'Neonatology Unit, Clinica Alemana de Santiago, Santiago, Chile.'}, {'ForeName': 'Lucia', 'Initials': 'L', 'LastName': 'Muñoz', 'Affiliation': 'Neonatology Unit, Hospital San Jose, Santiago, Chile.'}, {'ForeName': 'Lilian', 'Initials': 'L', 'LastName': 'Lopez', 'Affiliation': 'Neonatology Unit, Hospital San Jose, Santiago, Chile.'}, {'ForeName': 'Andrés', 'Initials': 'A', 'LastName': 'Mendiburo-Seguel', 'Affiliation': 'Faculty of Education and Social Sciences, Universidad Andrés Bello, Santiago, Chile.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Simó', 'Affiliation': 'Faculty of Psychology, Universitat de Valencia, Valencia, Spain.'}, {'ForeName': 'Pascual', 'Initials': 'P', 'LastName': 'Palau Subiela', 'Affiliation': 'Spain Association for Infant Mental Health Since Gestation, Valencia, Spain.'}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Guedeney', 'Affiliation': 'Hospital Bichat Claude Bernard, Assistance Publique-Hôpitaux de Paris, Paris, France.'}]",JMIR research protocols,['10.2196/17943'] 2119,32589229,"Association Between Lifestyle Factors, Vitamin and Garlic Supplementation, and Gastric Cancer Outcomes: A Secondary Analysis of a Randomized Clinical Trial.","Importance The associations of lifestyle factors with gastric cancer (GC) are still underexplored in populations in China. Long-term nutritional supplementation may prevent GC in high-risk populations, but the possible effect modification by lifestyle factors remains unknown. Objective To evaluate how lifestyle factors, including smoking, alcohol intake, and diet, may change the risk of GC incidence and mortality and whether the effects of vitamin and garlic supplementation on GC are associated with major lifestyle factors. Design, Setting, and Participants This is a secondary analysis of the Shandong Intervention Trial, a masked, randomized, placebo-controlled trial that aimed to assess the effect of vitamin and garlic supplementations and Helicobacter pylori treatment on GC in a factorial design with 22.3 years of follow-up. The study took place in Linqu County, Shandong province, China, a high-risk area for GC. Data were collected from Jully 1995 to December 2017. Overall, 3365 participants aged 35 to 64 years identified in 13 randomly selected villages who agreed to undergo gastroscopy were invited to participate in the trial and were included in the analysis. Data analysis was conducted from March to May 2019. Interventions Participants received vitamin and garlic supplementation for 7.3 years, H pylori treatment for 2 weeks (among participants with H pylori ), or placebo. Main Outcomes and Measures The primary outcomes were GC incidence and GC mortality (1995-2017). We also examined the progression of gastric lesions (1995-2003) as a secondary outcome. Results Of the 3365 participants (mean [SD] age, 47.1 [9.2] years; 1639 [48.7%] women), 1677 (49.8%) were randomized to receive active vitamin supplementation, with 1688 (50.2%) receiving placebo, and 1678 (49.9%) receiving active garlic supplementation, with 1687 (50.1%) receiving placebo. Overall, 151 GC cases (4.5%) and 94 GC deaths (2.8%) were identified. Smoking was associated with increased risk of GC incidence (odds ratio, 1.72; 95% CI, 1.003-2.93) and mortality (hazard ratio [HR], 2.01; 95% CI, 1.01-3.98). Smoking was not associated with changes to the effects of vitamin or garlic supplementation. The protective effect on GC mortality associated with garlic supplementation was observed only among those not drinking alcohol (never drank alcohol: HR, 0.33; 95% CI, 0.15-0.75; ever drank alcohol: HR, 0.92; 95% CI, 0.55-1.54; P for interaction = .03), and significant interactions were only seen among participants with H pylori (never drank alcohol: HR, 0.31; 95% CI, 0.12-0.78; ever drank alcohol: HR, 0.91; 95% CI, 0.52-1.60; P for interaction = .04). No significant interactions between vitamin supplementation and lifestyle factors were found. Conclusions and Relevance In this secondary analysis of a randomized clinical trial, smoking was associated with an increased risk of GC incidence and mortality. Not drinking alcohol was associated with a stronger beneficial effect of garlic supplementation on GC prevention. Our findings provide new insights into lifestyle intervention for GC prevention, suggesting that mass GC prevention strategies may need to be tailored to specific population subgroups to maximize the potential beneficial effect. Trial Registration ClinicalTrials.gov Identifier: NCT00339768.",2020,"Smoking was associated with increased risk of GC incidence (odds ratio, 1.72; 95% CI, 1.003-2.93) and mortality (hazard ratio [HR], 2.01; 95% CI, 1.01-3.98).","['3365 participants aged 35 to 64 years identified in 13 randomly selected villages who agreed to undergo gastroscopy were invited to participate in the trial and were included in the analysis', 'Linqu County, Shandong province, China, a high-risk area for GC', '3365 participants (mean [SD] age, 47.1 [9.2] years; 1639 [48.7%] women), 1677 (49.8']","['vitamin and garlic supplementation', 'active garlic supplementation', 'vitamin and garlic supplementations and Helicobacter pylori treatment', 'vitamin or garlic supplementation', 'garlic supplementation', 'active vitamin supplementation', 'placebo']","['risk of GC incidence', 'progression of gastric lesions', 'risk of GC incidence and mortality', 'mortality', 'GC incidence and GC mortality', 'Lifestyle Factors, Vitamin and Garlic Supplementation, and Gastric Cancer Outcomes', 'GC mortality associated with garlic supplementation']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0562518', 'cui_str': 'Village environment'}, {'cui': 'C0017195', 'cui_str': 'Endoscopy of stomach'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0024623', 'cui_str': 'Malignant tumor of stomach'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C5191219', 'cui_str': '9.2'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0042890', 'cui_str': 'Vitamin'}, {'cui': 'C0331590', 'cui_str': 'Allium ameloprasum'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0079488', 'cui_str': 'Helicobacter pylori'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0302837', 'cui_str': 'Vitamin supplement agent'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0024623', 'cui_str': 'Malignant tumor of stomach'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0679408', 'cui_str': 'Lesion of stomach'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0042890', 'cui_str': 'Vitamin'}, {'cui': 'C0331590', 'cui_str': 'Allium ameloprasum'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}]",3365.0,0.29091,"Smoking was associated with increased risk of GC incidence (odds ratio, 1.72; 95% CI, 1.003-2.93) and mortality (hazard ratio [HR], 2.01; 95% CI, 1.01-3.98).","[{'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Guo', 'Affiliation': 'Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education-Beijing), Department of Cancer Epidemiology, Peking University Cancer Hospital and Institute, Beijing, China.'}, {'ForeName': 'Zhe-Xuan', 'Initials': 'ZX', 'LastName': 'Li', 'Affiliation': 'Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education-Beijing), Department of Cancer Epidemiology, Peking University Cancer Hospital and Institute, Beijing, China.'}, {'ForeName': 'Jing-Yu', 'Initials': 'JY', 'LastName': 'Zhang', 'Affiliation': 'Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education-Beijing), Department of Cancer Epidemiology, Peking University Cancer Hospital and Institute, Beijing, China.'}, {'ForeName': 'Jun-Ling', 'Initials': 'JL', 'LastName': 'Ma', 'Affiliation': 'Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education-Beijing), Department of Cancer Epidemiology, Peking University Cancer Hospital and Institute, Beijing, China.'}, {'ForeName': 'Lian', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education-Beijing), Department of Cancer Epidemiology, Peking University Cancer Hospital and Institute, Beijing, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education-Beijing), Department of Cancer Epidemiology, Peking University Cancer Hospital and Institute, Beijing, China.'}, {'ForeName': 'Tong', 'Initials': 'T', 'LastName': 'Zhou', 'Affiliation': 'Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education-Beijing), Department of Cancer Epidemiology, Peking University Cancer Hospital and Institute, Beijing, China.'}, {'ForeName': 'Wei-Dong', 'Initials': 'WD', 'LastName': 'Liu', 'Affiliation': 'Linqu County Public Health Bureau, Shandong, China.'}, {'ForeName': 'Zhong-Xiang', 'Initials': 'ZX', 'LastName': 'Han', 'Affiliation': 'Linqu County Public Health Bureau, Shandong, China.'}, {'ForeName': 'Wen-Qing', 'Initials': 'WQ', 'LastName': 'Li', 'Affiliation': 'Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education-Beijing), Department of Cancer Epidemiology, Peking University Cancer Hospital and Institute, Beijing, China.'}, {'ForeName': 'Kai-Feng', 'Initials': 'KF', 'LastName': 'Pan', 'Affiliation': 'Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education-Beijing), Department of Cancer Epidemiology, Peking University Cancer Hospital and Institute, Beijing, China.'}, {'ForeName': 'Wei-Cheng', 'Initials': 'WC', 'LastName': 'You', 'Affiliation': 'Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education-Beijing), Department of Cancer Epidemiology, Peking University Cancer Hospital and Institute, Beijing, China.'}]",JAMA network open,['10.1001/jamanetworkopen.2020.6628'] 2120,32594273,Protective effect of the oral administration of cystine and theanine on oxaliplatin-induced peripheral neuropathy: a pilot randomized trial.,"BACKGROUND Oxaliplatin, one of the key cytotoxic drugs for colorectal cancer, frequently causes peripheral neuropathy which leads to dose modification and decreased patients' quality of life. However, prophylactic or therapeutic measures have not yet been established. Orally administered amino acids, cystine and theanine, promoted the synthesis of glutathione which was one of the potential candidates for preventing the neuropathy. The aim of this study was to determine whether daily oral administration of cystine and theanine attenuated oxaliplatin-induced peripheral neuropathy (OXLIPN). METHODS Twenty-eight colorectal cancer patients who received infusional 5-fluorouracil, leucovorin, and oxaliplatin (mFOLFOX6) therapy were randomly and evenly assigned to the cystine and theanine group and the control group. OXLIPN was assessed up to the sixth course using original 7-item questionnaire as well as Common Terminology Criteria for Adverse Events (CTCAE) grading scale. RESULTS Neuropathy scores according to our original questionnaire were significantly smaller in the cystine and theanine group at the fourth (p = 0.026), fifth (p = 0.029), and sixth course (p = 0.038). Furthermore, significant differences were also observed in CTCAE neuropathy grades at the fourth (p = 0.037) and the sixth course (p = 0.017). There was one patient in each group who required dose reduction due to OXLIPN. Except for neurotoxicity, no significant differences were noted in the incidence of adverse events, and the total amount of administered oxaliplatin. CONCLUSION The results demonstrated the daily oral administration of cystine and theanine attenuated OXLIPN.",2020,"Except for neurotoxicity, no significant differences were noted in the incidence of adverse events, and the total amount of administered oxaliplatin. ","['Twenty-eight colorectal cancer patients who received', 'induced peripheral neuropathy']","['oxaliplatin', 'cystine and theanine attenuated oxaliplatin', 'infusional 5-fluorouracil, leucovorin, and oxaliplatin (mFOLFOX6) therapy', 'amino acids, cystine and theanine', 'cystine and theanine', 'Oxaliplatin', 'cystine and theanine group and the control group']","['Neuropathy scores', 'total amount of administered oxaliplatin', 'neurotoxicity', 'OXLIPN', 'CTCAE neuropathy grades', 'incidence of adverse events']","[{'cui': 'C4283787', 'cui_str': '28'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C1869037', 'cui_str': 'Peripheral neuropathy (SMQ)'}]","[{'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0010682', 'cui_str': 'Cystine'}, {'cui': 'C0076380', 'cui_str': 'theanine'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0023413', 'cui_str': 'Leucovorin'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0002520', 'cui_str': 'amino acids'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0442874', 'cui_str': 'Neuropathy'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0235032', 'cui_str': 'Neurotoxicity'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C1869037', 'cui_str': 'Peripheral neuropathy (SMQ)'}, {'cui': 'C1516728', 'cui_str': 'National Cancer Institute common terminology criteria for adverse events'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",28.0,0.0213027,"Except for neurotoxicity, no significant differences were noted in the incidence of adverse events, and the total amount of administered oxaliplatin. ","[{'ForeName': 'Minoru', 'Initials': 'M', 'LastName': 'Kobayashi', 'Affiliation': 'Department of Surgery, Sendai City Medical Center, 5-22-1 Tsurugaya, Miyagino-ku, Sendai, Miyagi, 983-0824, Japan.'}, {'ForeName': 'Ryuichiro', 'Initials': 'R', 'LastName': 'Sato', 'Affiliation': 'Department of Surgery, Sendai City Medical Center, 5-22-1 Tsurugaya, Miyagino-ku, Sendai, Miyagi, 983-0824, Japan.'}, {'ForeName': 'Toshihiro', 'Initials': 'T', 'LastName': 'Komura', 'Affiliation': 'Department of Surgery, Omagari Kousei Medical Center, Akita, Akita, Japan.'}, {'ForeName': 'Hidetaka', 'Initials': 'H', 'LastName': 'Ichikawa', 'Affiliation': 'Department of Surgery, Tohoku University Graduate School of Medicine, Sendai, Miyagi, Japan.'}, {'ForeName': 'Tomoaki', 'Initials': 'T', 'LastName': 'Hirashima', 'Affiliation': 'Department of Surgery, Tohoku University Graduate School of Medicine, Sendai, Miyagi, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Otake', 'Affiliation': 'Department of Surgery, Sendai City Medical Center, 5-22-1 Tsurugaya, Miyagino-ku, Sendai, Miyagi, 983-0824, Japan.'}, {'ForeName': 'Naoya', 'Initials': 'N', 'LastName': 'Akazawa', 'Affiliation': 'Department of Surgery, Sendai City Medical Center, 5-22-1 Tsurugaya, Miyagino-ku, Sendai, Miyagi, 983-0824, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Yazawa', 'Affiliation': 'Department of Surgery, Sendai City Medical Center, 5-22-1 Tsurugaya, Miyagino-ku, Sendai, Miyagi, 983-0824, Japan.'}, {'ForeName': 'Tomoya', 'Initials': 'T', 'LastName': 'Abe', 'Affiliation': 'Department of Surgery, Sendai City Medical Center, 5-22-1 Tsurugaya, Miyagino-ku, Sendai, Miyagi, 983-0824, Japan.'}, {'ForeName': 'Takaho', 'Initials': 'T', 'LastName': 'Okada', 'Affiliation': 'Department of Surgery, Sendai City Medical Center, 5-22-1 Tsurugaya, Miyagino-ku, Sendai, Miyagi, 983-0824, Japan.'}, {'ForeName': 'Tetsuya', 'Initials': 'T', 'LastName': 'Kakita', 'Affiliation': 'Department of Surgery, Sendai City Medical Center, 5-22-1 Tsurugaya, Miyagino-ku, Sendai, Miyagi, 983-0824, Japan.'}, {'ForeName': 'Masaya', 'Initials': 'M', 'LastName': 'Oikawa', 'Affiliation': 'Department of Surgery, Sendai City Medical Center, 5-22-1 Tsurugaya, Miyagino-ku, Sendai, Miyagi, 983-0824, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Tsuchiya', 'Affiliation': 'Department of Surgery, Sendai City Medical Center, 5-22-1 Tsurugaya, Miyagino-ku, Sendai, Miyagi, 983-0824, Japan. tsuchiya@openhp.or.jp.'}]",International journal of clinical oncology,['10.1007/s10147-020-01728-4'] 2121,32594305,Rectal Omeprazole in Infants With Gastroesophageal Reflux Disease: A Randomized Pilot Trial.,"BACKGROUND AND OBJECTIVE Omeprazole is a proton pump inhibitor that is used in acid suppression therapy in infants. Infants cannot swallow the oral tablets or capsules. Since, infants require a non-standard dose of omeprazole, the granules or tablets are often crushed or suspended in water or sodium bicarbonate, which may destroy the enteric coating. In this study we explore the efficacy and pharmacokinetics of rectally administered omeprazole in infants with gastroesophageal reflux disease (GERD) due to esophageal atresia (EA) or congenital diaphragmatic hernia (CDH) and compare these with orally administered omeprazole. METHODS Infants (6-12 weeks postnatal and bodyweight > 3 kg) with EA or CDH and GERD were randomized to receive a single dose of 1 mg/kg omeprazole rectally or orally. The primary outcome was the percentage of infants for whom omeprazole was effective according to predefined criteria for 24-h intraesophageal pH. Secondary outcomes were the percentages of time that gastric pH was < 3 or < 4, as well as the pharmacokinetic parameters. RESULTS Seventeen infants, 4 with EA and 13 with CDH, were included. The proportion of infants for whom omeprazole was effective was 56% (5 of 9 infants) after rectal administration and 50% (4 of 8 infants) after oral administration. The total reflux time in minutes and percentages and the number of reflux episodes of pH < 4 decreased statistically significantly after both rectal and oral omeprazole administration. Rectal and oral administration of omeprazole resulted in similar serum exposure. CONCLUSIONS A single rectal omeprazole dose (1 mg/kg) results in consistent increases in intraesophageal and gastric pH in infants with EA- or CDH-related GERD, similar to an oral dose. Considering the challenges with existing oral formulations, rectal omeprazole presents as an innovative, promising alternative for infants with pathological GERD. CLINICAL TRIAL REGISTER ClinicalTrials.gov Identifier: NCT00226044.",2020,The total reflux time in minutes and percentages and the number of reflux episodes of pH < 4 decreased statistically significantly after both rectal and oral omeprazole administration.,"['3\xa0kg) with EA or CDH and GERD', 'Infants', 'Seventeen infants, 4 with EA and 13 with CDH, were included', 'infants with gastroesophageal reflux disease (GERD) due to esophageal atresia (EA) or congenital diaphragmatic hernia (CDH', 'Infants (6-12\xa0weeks postnatal and bodyweight ', 'infants', 'With Gastroesophageal Reflux Disease', 'infants with pathological GERD']","['omeprazole', 'Rectal Omeprazole', 'Omeprazole', 'omeprazole rectally or orally', 'rectal omeprazole']","['efficacy and pharmacokinetics', 'percentages of time that gastric pH', 'intraesophageal and gastric pH', 'number of reflux episodes of pH', 'total reflux time']","[{'cui': 'C0014850', 'cui_str': 'Congenital atresia of esophagus'}, {'cui': 'C0235833', 'cui_str': 'Congenital diaphragmatic hernia'}, {'cui': 'C0017168', 'cui_str': 'Gastroesophageal reflux disease'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0450331', 'cui_str': '17'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0443281', 'cui_str': 'Postnatal'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}]","[{'cui': 'C0028978', 'cui_str': 'Omeprazole'}, {'cui': 'C0205052', 'cui_str': 'Rectal'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1168023', 'cui_str': 'Gastric pH'}, {'cui': 'C2959898', 'cui_str': 'Intraesophageal route'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C4317146', 'cui_str': 'Acid reflux'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",,0.126466,The total reflux time in minutes and percentages and the number of reflux episodes of pH < 4 decreased statistically significantly after both rectal and oral omeprazole administration.,"[{'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Bestebreurtje', 'Affiliation': 'Department of Clinical Pharmacology, Tergooi Hospital, Hilversum, The Netherlands.'}, {'ForeName': 'Barbara A E', 'Initials': 'BAE', 'LastName': 'de Koning', 'Affiliation': 'Division of Pediatric Gastroenterology, Department of Pediatrics, Erasmus MC Sophia, Rotterdam, The Netherlands.'}, {'ForeName': 'Nel', 'Initials': 'N', 'LastName': 'Roeleveld', 'Affiliation': 'Department for Health Evidence, Radboud Institute for Health Sciences, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Catherijne A J', 'Initials': 'CAJ', 'LastName': 'Knibbe', 'Affiliation': 'Department of Clinical Pharmacology, St Antonius Hospital, Nieuwegein, The Netherlands.'}, {'ForeName': 'Dick', 'Initials': 'D', 'LastName': 'Tibboel', 'Affiliation': 'Intensive Care and Department of Pediatric Surgery, Erasmus MC Sophia, Rotterdam, The Netherlands.'}, {'ForeName': 'Bianca', 'Initials': 'B', 'LastName': 'van Groen', 'Affiliation': 'Intensive Care and Department of Pediatric Surgery, Erasmus MC Sophia, Rotterdam, The Netherlands.'}, {'ForeName': 'Cees P', 'Initials': 'CP', 'LastName': 'van de Ven', 'Affiliation': 'Department of Pediatric Surgery, Prinses Maxima Hospital, Utrecht, The Netherlands.'}, {'ForeName': 'Frans B', 'Initials': 'FB', 'LastName': 'Plötz', 'Affiliation': 'Department of Pediatrics, Tergooi Hospital, Hilversum, The Netherlands.'}, {'ForeName': 'Saskia N', 'Initials': 'SN', 'LastName': 'de Wildt', 'Affiliation': 'Intensive Care and Department of Pediatric Surgery, Erasmus MC Sophia, Rotterdam, The Netherlands. Saskia.deWildt@radboudumc.nl.'}]",European journal of drug metabolism and pharmacokinetics,['10.1007/s13318-020-00630-8'] 2122,32594328,Correction to: Footprint preparation with nanofractures in a supraspinatus repair cuts in half the retear rate at 1-year follow-up. A randomized controlled trial.,The article Footprint preparation with nanofractures in a supraspinatus repair cuts in half the retear rate at 1-year follow-up.,2020,The article Footprint preparation with nanofractures in a supraspinatus repair cuts in half the retear rate at 1-year follow-up.,[],[],[],[],[],[],,0.062914,The article Footprint preparation with nanofractures in a supraspinatus repair cuts in half the retear rate at 1-year follow-up.,"[{'ForeName': 'Miguel Angel', 'Initials': 'MA', 'LastName': 'Ruiz Ibán', 'Affiliation': 'Unidad de Hombro y Codo, Hospital Universitario Ramón y Cajal, Cta Colmenar km 9,100, 28046, Madrid, Spain. drmri@hotmail.com.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Sanchez Alepuz', 'Affiliation': 'Hospital IMED Valencia, Valencia, Spain.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Diaz Heredia', 'Affiliation': 'Unidad de Hombro y Codo, Hospital Universitario Ramón y Cajal, Cta Colmenar km 9,100, 28046, Madrid, Spain.'}, {'ForeName': 'Abdul-Ilah', 'Initials': 'AI', 'LastName': 'Hachem', 'Affiliation': 'Head of the Shoulder Unit, Hospital Universitario de Bellvitge, Barcelona, Spain.'}, {'ForeName': 'Leon', 'Initials': 'L', 'LastName': 'Ezagüi Bentolila', 'Affiliation': 'Hospital Egarsat, Barcelona, Spain.'}, {'ForeName': 'Angel', 'Initials': 'A', 'LastName': 'Calvo', 'Affiliation': 'Arthrosport, Zaragoza, Spain.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Verdú', 'Affiliation': 'Unidad de Hombro y Codo, Hospital General Universitario de Elche, Elche, Alicante, Spain.'}, {'ForeName': 'Ignacio', 'Initials': 'I', 'LastName': 'de Rus Aznar', 'Affiliation': 'Unidad de Hombro y Codo, Hospital Universitario Ramón y Cajal, Cta Colmenar km 9,100, 28046, Madrid, Spain.'}, {'ForeName': 'Francesc', 'Initials': 'F', 'LastName': 'Soler Romagosa', 'Affiliation': 'Traumadvance, Terrassa, Barcelona, Spain.'}]","Knee surgery, sports traumatology, arthroscopy : official journal of the ESSKA",['10.1007/s00167-020-06118-x'] 2123,32594370,Efficacy of low or standard rituximab-based protocols and comparison to Ponticelli's regimen in membranous nephropathy.,"BACKGROUND Patients (pts) with primary Membranous nephropathy (MN) have an autoimmune disease caused by autoantibodies against podocyte antigens and 60-80% of them have antibodies directed against the M-type phospholipase A2 receptor (PLA2R). Immunosuppressive treatment is recommended in high-medium risk pts. Recently the use of rituximab (RTX), has emerged as an important therapeutic option in pts with primary MN. The appropriate cumulative dose of RTX in PMN pts is still uncertain, and favorable outcomes even with low-dose of RTX has been described. We compared efficacy and safety of 3 different treatment regimens: low-dose RTX (Protocol 1, one dose of RTX 375 mg/m 2 ), standard RTX protocol (Protocol 2, four weekly doses of rituximab 375 mg/m 2 ) and Ponticelli's regimen. METHODS 42 pts with primary MN and nephrotic syndrome were assigned to Protocol 1 (14 pts) or Protocol 2 (14 pts). All patients were followed for 24 months after RTX. Fourteen pts, matched for age and baseline serum creatinine (sCr) and proteinuria, treated with Ponticelli's regimen were examined as controls. RESULTS At 24 months, a significant improvement in proteinuria levels was observed in pts treated with Protocol 1 (7.5 ± 4.8 at T0; 0.21 ± 0.15 at T24, p < 0.01), Protocol 2 (5.1 ± 1.41 g/24 at T0; 0.35 ± 0.39 at T24 p < 0.01) and controls (8.27 ± 4.78 T0; 2.2 ± 1.9 g/24 h at T24, p < 0.01). No differences in clinical response (p = 0.53) was observed comparing the 3 groups. CONCLUSIONS Our data suggest that the RTX is a promising alternative to Ponticelli's regimen even at low-doses. This makes RTX a cost-effective treatment of primary MN in the short and medium terms.",2020,"No differences in clinical response (p = 0.53) was observed comparing the 3 groups. ","['pts with primary MN', '42 pts with primary MN and nephrotic syndrome', 'membranous nephropathy', ""Fourteen pts, matched for age and baseline serum creatinine (sCr) and proteinuria, treated with Ponticelli's regimen were examined as controls"", 'Patients (pts) with primary Membranous nephropathy (MN']","[""low or standard rituximab-based protocols and comparison to Ponticelli's regimen"", ""rituximab 375\xa0mg/m 2 ) and Ponticelli's regimen"", 'rituximab (RTX', 'RTX', 'Immunosuppressive treatment']","['efficacy and safety', 'clinical response', 'proteinuria levels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0017665', 'cui_str': 'Membranous glomerulonephritis'}, {'cui': 'C0027726', 'cui_str': 'Nephrotic syndrome'}, {'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum'}, {'cui': 'C0033687', 'cui_str': 'Proteinuria'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0332128', 'cui_str': 'Examined for'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C4517745', 'cui_str': '375'}, {'cui': 'C0021081', 'cui_str': 'Immunosuppressant agent'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0033687', 'cui_str': 'Proteinuria'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.0323735,"No differences in clinical response (p = 0.53) was observed comparing the 3 groups. ","[{'ForeName': 'Roberta', 'Initials': 'R', 'LastName': 'Fenoglio', 'Affiliation': 'CMID-Nephrology and Dialysis Unit (ERK-Net Member), Coordinating Center of the Network for Rare Diseases of Piedmont and Aosta Valley, University of Turin and San Giovanni Bosco Hospital, Piazza del Donatore di Sangue 3, 10054, Turin, Italy.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Baldovino', 'Affiliation': 'CMID-Nephrology and Dialysis Unit (ERK-Net Member), Coordinating Center of the Network for Rare Diseases of Piedmont and Aosta Valley, University of Turin and San Giovanni Bosco Hospital, Piazza del Donatore di Sangue 3, 10054, Turin, Italy.'}, {'ForeName': 'Savino', 'Initials': 'S', 'LastName': 'Sciascia', 'Affiliation': 'CMID-Nephrology and Dialysis Unit (ERK-Net Member), Coordinating Center of the Network for Rare Diseases of Piedmont and Aosta Valley, University of Turin and San Giovanni Bosco Hospital, Piazza del Donatore di Sangue 3, 10054, Turin, Italy.'}, {'ForeName': 'Emanuele', 'Initials': 'E', 'LastName': 'De Simone', 'Affiliation': 'CMID-Nephrology and Dialysis Unit (ERK-Net Member), Coordinating Center of the Network for Rare Diseases of Piedmont and Aosta Valley, University of Turin and San Giovanni Bosco Hospital, Piazza del Donatore di Sangue 3, 10054, Turin, Italy.'}, {'ForeName': 'Giulio', 'Initials': 'G', 'LastName': 'Del Vecchio', 'Affiliation': 'CMID-Nephrology and Dialysis Unit (ERK-Net Member), Coordinating Center of the Network for Rare Diseases of Piedmont and Aosta Valley, University of Turin and San Giovanni Bosco Hospital, Piazza del Donatore di Sangue 3, 10054, Turin, Italy.'}, {'ForeName': 'Michela', 'Initials': 'M', 'LastName': 'Ferro', 'Affiliation': 'CMID-Nephrology and Dialysis Unit (ERK-Net Member), Coordinating Center of the Network for Rare Diseases of Piedmont and Aosta Valley, University of Turin and San Giovanni Bosco Hospital, Piazza del Donatore di Sangue 3, 10054, Turin, Italy.'}, {'ForeName': 'Giacomo', 'Initials': 'G', 'LastName': 'Quattrocchio', 'Affiliation': 'CMID-Nephrology and Dialysis Unit (ERK-Net Member), Coordinating Center of the Network for Rare Diseases of Piedmont and Aosta Valley, University of Turin and San Giovanni Bosco Hospital, Piazza del Donatore di Sangue 3, 10054, Turin, Italy.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Naretto', 'Affiliation': 'CMID-Nephrology and Dialysis Unit (ERK-Net Member), Coordinating Center of the Network for Rare Diseases of Piedmont and Aosta Valley, University of Turin and San Giovanni Bosco Hospital, Piazza del Donatore di Sangue 3, 10054, Turin, Italy.'}, {'ForeName': 'Dario', 'Initials': 'D', 'LastName': 'Roccatello', 'Affiliation': 'CMID-Nephrology and Dialysis Unit (ERK-Net Member), Coordinating Center of the Network for Rare Diseases of Piedmont and Aosta Valley, University of Turin and San Giovanni Bosco Hospital, Piazza del Donatore di Sangue 3, 10054, Turin, Italy. dario.roccatello@unito.it.'}]",Journal of nephrology,['10.1007/s40620-020-00781-6'] 2124,32594451,Efficacy and safety of hydroxychloroquine as add-on therapy in uncontrolled type 2 diabetes patients who were using two oral antidiabetic drugs.,"OBJECTIVE To evaluate the Safety and Efficacy of Hydroxychloroquine as add-on therapy in uncontrolled type 2 diabetes patients who were using two oral antidiabetic drugs. MATERIALS AND METHODS This was a double blind, placebo controlled, parallel group study in 304 inadequately controlled type 2 diabetes (T2DM) subjects with two oral antidiabetic drugs (glimepiride 4 mg and metformin 500 mg) were randomised to hydroxychloroquine (HCQ) 200 mg, 300 mg, 400 mg once daily (OD) or placebo. Dose of hydroxychloroquine was selected as per body weight of the subject. Primary end point was glycated haemoglobin (HbA1c) change at week 12 from baseline. Secondary endpoint was change in fasting plasma glucose (FPG), post prandial plasma glucose (PPG), body weight and any adverse reaction including no of hypoglycemic events, as well as a change in the percentage of subjects with A1C < 7.0% and > 6.5% after 12 weeks of treatment.. In follow-up of 400 mg once daily was once again divided to 200 mg twice daily (BD) to study the effect on tolerability profile for further 12 weeks. RESULTS Hydroxychloroquine was associated with significant reduction in HbA1c from baseline (7-8.5%) in 12 weeks -0.78%, -0.91% and 1.2% for hydroxychloroquine 200 mg, 300 mg and 400 mg OD, respectively, versus 0.13% with placebo (P < 0.005). FPG and PPG were reduced by -25 to -38 mg/dl and 34-53 mg/dl, respectively. Body weight also reduced in each group of HCQ. Hypoglycemia was reported only with 300 mg (1.2%) and 400 mg (2.1%) group of HCQ. It was observed that patients who complains with mild GI disturbance with HCQ 400 mg glycemic efficacy was maintained with 200 mg BD with significant relief of the symptoms. CONCLUSION Hydroxychloroquine added to sulphonylurea and metformin, improves glycemic control significantly in T2DM patients. Glycemic effect of different dose of hydroxychloroquine is dose dependent. The safety/tolerability profile of hydroxychloroquine was favourable except GI disturbance which is more frequent with 400 mg. This can be avoided with 200 mg BD without compromise on efficacy.",2020,"FPG and PPG were reduced by -25 to -38 mg/dl and 34-53 mg/dl, respectively.","['500\xa0mg', '304 inadequately controlled type 2 diabetes (T2DM) subjects with two', 'T2DM patients', 'uncontrolled type 2 diabetes patients who were using two oral antidiabetic drugs']","['hydroxychloroquine', 'Hydroxychloroquine', 'hydroxychloroquine (HCQ', 'sulphonylurea and metformin', 'oral antidiabetic drugs (glimepiride 4\xa0mg and metformin', 'placebo']","['Hypoglycemia', 'Safety and Efficacy', 'FPG and PPG', 'safety/tolerability profile', 'glycated haemoglobin (HbA1c) change', 'Efficacy and safety', 'Body weight', 'glycemic control', 'tolerability profile', 'glycemic efficacy', 'Glycemic effect', 'fasting plasma glucose (FPG), post prandial plasma glucose (PPG), body weight and any adverse reaction including no of hypoglycemic events, as well as a change in the percentage of subjects with A1C']","[{'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205318', 'cui_str': 'Uncontrolled'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0935929', 'cui_str': 'Antidiabetic agent'}]","[{'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}, {'cui': 'C0038766', 'cui_str': 'Sulfonylurea'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0935929', 'cui_str': 'Antidiabetic agent'}, {'cui': 'C0986240', 'cui_str': 'glimepiride 4 MG'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0020616', 'cui_str': 'Hypoglycemic agent'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C4521595', 'cui_str': 'US Military enlisted E3'}]",,0.111767,"FPG and PPG were reduced by -25 to -38 mg/dl and 34-53 mg/dl, respectively.","[{'ForeName': 'H N', 'Initials': 'HN', 'LastName': 'Chakravarti', 'Affiliation': 'Department of Medicine, Medical College and Hospital, Kolkata, West Bengal, India.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Nag', 'Affiliation': 'Department of Medicine, Medical College and Hospital, Kolkata, West Bengal, India. dravicknag@rediffmail.com.'}]",Journal of endocrinological investigation,['10.1007/s40618-020-01330-5'] 2125,32594567,A computer-guided quality improvement tool for primary health care: cost-effectiveness analysis based on TORPEDO trial data.,"OBJECTIVE To assess the cost-effectiveness of a computer-guided quality improvement intervention for primary health care management of cardiovascular disease (CVD) in people at high risk. DESIGN Modelled cost-effectiveness analysis of the HealthTracker intervention and usual care for people with high CVD risk, based on TORPEDO trial data on prescribing patterns, changes in intermediate risk factors (low-density lipoprotein cholesterol, systolic blood pressure), and Framingham risk scores. PARTICIPANTS Hypothetical population of people with high CVD risk attending primary health care services in a New South Wales primary health network (PHN) of mean size. INTERVENTION HealthTracker, integrated into health care provider electronic health record systems, provides real time decision support, risk communication, a clinical audit tool, and a web portal for performance feedback. MAIN OUTCOME MEASURES Incremental cost-effectiveness ratios (ICERs): difference in costs of the intervention and usual care divided by number of CVD events averted with HealthTracker. RESULTS The estimated numbers of major CVD events over five years per 1000 patients at high CVD risk were lower in PHNs using HealthTracker, both for patients with prior CVD events (secondary prevention; 259 v 267 with usual care) and for those without prior events (primary prevention; 168 v 176). Medication costs were higher and hospitalisation costs lower with HealthTracker than with usual care for both primary and secondary prevention. The estimated ICER for one averted CVD event was $7406 for primary prevention and $17 988 for secondary prevention. CONCLUSION Modelled cost-effectiveness analyses provide information that can assist decisions about investing in health care quality improvement interventions. We estimate that HealthTracker could prevent major CVD events for less than $20 000 per event averted. TRIAL REGISTRATION (TORPEDO) Australian New Zealand Clinical Trials Registry, ACTRN 12611000478910.",2020,Medication costs were higher and hospitalisation costs lower with HealthTracker than with usual care for both primary and secondary prevention.,"['primary health care', 'primary health care management of cardiovascular disease (CVD) in people at high risk', 'people with high CVD risk', 'Hypothetical population of people with high CVD risk attending primary health care services in a New South Wales primary health network (PHN) of mean size']","['computer-guided quality improvement intervention', 'HealthTracker intervention and usual care']","['Medication costs', 'estimated numbers of major CVD events', 'major CVD events', 'intermediate risk factors (low-density lipoprotein cholesterol, systolic blood pressure), and Framingham risk scores', 'Incremental cost-effectiveness ratios (ICERs): difference in costs of the intervention and usual care divided by number of CVD events averted with HealthTracker', 'cost-effectiveness']","[{'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0043015', 'cui_str': 'Wales'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0150775', 'cui_str': 'Social Networks'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0456389', 'cui_str': 'Size'}]","[{'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C2936612', 'cui_str': 'Quality Improvement'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332849', 'cui_str': 'Divide'}]",,0.109009,Medication costs were higher and hospitalisation costs lower with HealthTracker than with usual care for both primary and secondary prevention.,"[{'ForeName': 'Bindu', 'Initials': 'B', 'LastName': 'Patel', 'Affiliation': 'The George Institute for Global Health, UNSW Sydney, Sydney, NSW.'}, {'ForeName': 'David P', 'Initials': 'DP', 'LastName': 'Peiris', 'Affiliation': 'The George Institute for Global Health, UNSW Sydney, Sydney, NSW.'}, {'ForeName': 'Anushka', 'Initials': 'A', 'LastName': 'Patel', 'Affiliation': 'The George Institute for Global Health, UNSW Sydney, Sydney, NSW.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Jan', 'Affiliation': 'The George Institute for Global Health, UNSW Sydney, Sydney, NSW.'}, {'ForeName': 'Mark F', 'Initials': 'MF', 'LastName': 'Harris', 'Affiliation': 'Centre for Primary Health Care and Equity, University of New South Wales, Sydney, NSW.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Usherwood', 'Affiliation': 'Sydney Medical School, the University of Sydney, Sydney, NSW.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Panaretto', 'Affiliation': 'Centre for Chronic Disease, University of Queensland, Brisbane, QLD.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Lung', 'Affiliation': 'The George Institute for Global Health, UNSW Sydney, Sydney, NSW.'}]",The Medical journal of Australia,['10.5694/mja2.50667'] 2126,32594587,Examining what factors mediate treatment effect in chronic low back pain: a mediation analysis of a Cognitive Functional Therapy clinical trial.,"Cognitive Functional Therapy (CFT) is a physiotherapist-led individualised intervention for people with people with non-specific chronic low back pain (CLBP), involving biopsychosocial pain education, graded movement exposure and lifestyle coaching. A multicentre randomised controlled trial (RCT), including 206 participants with CLBP in Ireland, supported CFT's effectiveness for reducing disability, but not pain, compared to a group exercise and education intervention. In this study, causal mediation analysis was used to determine whether the effect of CFT on disability and the lack of effect on pain (relative to a group exercise and education intervention) is mediated by certain psychological and lifestyle factors. Hypothesised mediators measured were pain self-efficacy, stress, fear of physical activity, coping, depression, anxiety, and sleep, at 6 months. The outcomes measured were functional disability and pain intensity at 12 months. This causal mediation study shows that the majority of benefit of CFT (relative to a group exercise and education intervention) for disability is due to increasing pain self-efficacy. CFT did not improve the majority of the hypothesised mediators (stress, fear of physical activity, coping, depression, anxiety and sleep) and these mediators were not associated with either disability or pain. Unfortunately, the proportion of missing data in this study is substantial and these findings can only be considered hypothesis-generating. Therefore, future research should examine replicating the results of this study to verify the role of self-efficacy and other proposed mediators (e.g. stress, coping, sleep, fear) on clinical outcomes.",2020,"CFT did not improve the majority of the hypothesised mediators (stress, fear of physical activity, coping, depression, anxiety and sleep) and these mediators were not associated with either disability or pain.","[""206 participants with CLBP in Ireland, supported CFT's effectiveness for reducing disability, but not pain, compared to a group exercise and education intervention"", 'people with people with non-specific chronic low back pain (CLBP', 'chronic low back pain']","['CFT', 'Cognitive Functional Therapy (CFT']","['functional disability and pain intensity', 'pain self-efficacy, stress, fear of physical activity, coping, depression, anxiety, and sleep', 'majority of the hypothesised mediators (stress, fear of physical activity, coping, depression, anxiety and sleep', 'disability or pain']","[{'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}, {'cui': 'C0022067', 'cui_str': 'Republic of Ireland'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205370', 'cui_str': 'Non-specific'}]","[{'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}]",206.0,0.0973819,"CFT did not improve the majority of the hypothesised mediators (stress, fear of physical activity, coping, depression, anxiety and sleep) and these mediators were not associated with either disability or pain.","[{'ForeName': 'Aoife', 'Initials': 'A', 'LastName': ""O'Neill"", 'Affiliation': 'School of Allied Health, University of Limerick, Limerick, Ireland.'}, {'ForeName': 'Kieran', 'Initials': 'K', 'LastName': ""O'Sullivan"", 'Affiliation': 'School of Allied Health, University of Limerick, Limerick, Ireland.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': ""O'Sullivan"", 'Affiliation': 'School of Physiotherapy and Exercise Science, Curtin University, Perth, Australia.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Purtill', 'Affiliation': 'Aging Research Centre, Health Research Institute, University of Limerick, Ireland.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': ""O'Keeffe"", 'Affiliation': 'School of Allied Health, University of Limerick, Limerick, Ireland.'}]","European journal of pain (London, England)",['10.1002/ejp.1624'] 2127,32594600,Comparative evaluation of therapeutic efficacy and safety of intralesional triamcinolone acetonide injection versus intralesional radiofrequency with intralesional triamcinolone acetonide in treatment of keloids.,"Management of keloid is difficult, so there is always a need for adequate and effective therapy. OBJECTIVES In this study we explored and compared the efficacy and synergistic effect of combined intralesional radiofrequency (RF) and intralesional triamcinolone acetonide[TAC] with intralesional triamcinolone acetonide alone in the treatment of keloids. METHODS Sixty patients with keloid were divided in two groups of 30 patients each. In both groups total 6 sittings every 3 weeks & post treatment follow up every 6 weeks was done. In Group A, intralesional TAC was given. In Group B, intralesional radiofrequency followed by triamcinolone was injected. RESULTS In this study, there were 29 males and 31 females. In Group A and B, 73.4% and 80% of the patients respectively achieved grade 4 improvement at the end of 33 weeks, but there was greater mean POSAS score decline in group B in comparison with group A at each visit compared to baseline. 6 patients in group A while 3 in group B showed recurrence. Side effects were equal in number in both groups CONCLUSION: Thus both the studied modalities of treatment produced equal efficacy and safety but with less recurrence in Group B. This article is protected by copyright. All rights reserved.",2020,Side effects were equal in number in both groups CONCLUSION:,"['Sixty patients with keloid were divided in two groups of 30 patients each', '29 males and 31 females']","['intralesional TAC', 'intralesional triamcinolone acetonide injection', 'combined intralesional radiofrequency (RF) and intralesional triamcinolone acetonide[TAC', 'intralesional radiofrequency followed by triamcinolone', 'triamcinolone acetonide']","['efficacy and synergistic effect', 'Side effects', 'efficacy and safety', 'recurrence', 'mean POSAS score decline']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022548', 'cui_str': 'Keloid'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C1512955', 'cui_str': 'Intralesional route'}, {'cui': 'C3489891', 'cui_str': 'TAC Alternate'}, {'cui': 'C0040866', 'cui_str': 'Triamcinolone acetonide'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0040864', 'cui_str': 'Triamcinolone'}, {'cui': 'C0332282', 'cui_str': 'Following'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",60.0,0.0271219,Side effects were equal in number in both groups CONCLUSION:,"[{'ForeName': 'Vishw', 'Initials': 'V', 'LastName': 'Kaushal', 'Affiliation': 'Guru gobind Singh Medical College and Hospital, Faridkot, Punjab, India.'}, {'ForeName': 'Sumir', 'Initials': 'S', 'LastName': 'Kumar', 'Affiliation': 'Guru gobind Singh Medical College and Hospital, Faridkot, Punjab, India.'}, {'ForeName': 'Balwinder Kaur', 'Initials': 'BK', 'LastName': 'Brar', 'Affiliation': 'Guru gobind Singh Medical College and Hospital, Faridkot, Punjab, India.'}, {'ForeName': 'Amarbir', 'Initials': 'A', 'LastName': 'Singh', 'Affiliation': 'Guru gobind Singh Medical College and Hospital, Faridkot, Punjab, India.'}]",Dermatologic therapy,['10.1111/dth.13919'] 2128,32594612,Safety and tolerability of elbasvir/grazoprevir in chronic hepatitis C virus therapy: integrated analysis from clinical trials.,"Direct-acting antiviral treatments for chronic hepatitis C virus (HCV) infection are generally safe; however, understanding the safety profile of each regimen is essential for their continued use. Safety data were pooled from 12 clinical trials of elbasvir/grazoprevir (EBR/GZR) that enrolled adult participants with HCV infection. Pooled analyses are presented for participants receiving EBR/GZR for 12 weeks and those receiving EBR/GZR plus ribavirin (RBV) for 16-18 weeks. Safety data are also presented for participants with comorbidities receiving EBR/GZR for 12 weeks in individual clinical trials (chronic kidney disease [CKD] stage 4/5, inherited blood disorders [IBLD], or receiving opioid agonist therapy [OAT]). Among 1743 participants receiving EBR/GZR for 12 weeks, 1068 (61.3%) reported ≥1 adverse event (AE) and 491 had AEs (28.2%) considered drug-related. The most frequent AEs were headache (10.6%), fatigue (8.7%), nasopharyngitis (5.8%), nausea (5.1%), and diarrhea (5.0%). Serious AEs were reported by 37 participants (2.1%), and 12 (0.7%) discontinued treatment due to an AE. In populations with CKD 4/5 or IBLD or receiving OAT, safety was similar in participants receiving EBR/GZR for 12 weeks and those receiving placebo. Some AEs occurred at higher frequencies in participants receiving RBV compared with those receiving EBR/GZR alone: fatigue (32.7% vs 8.7%); headache (21.6% vs 10.6%); and nausea (15.8% vs 5.1%). Safety was similar in participants with and those without cirrhosis. Grade 3/4 alanine aminotransferase elevations were reported in 0.7% participants.EBR/GZR is a safe treatment option for individuals with HCV genotype (GT)1 or GT4 infections, even those with challenging comorbidities such as CKD or IBLD and in those receiving OAT.",2020,"EBR/GZR is a safe treatment option for individuals with HCV genotype (GT)1 or GT4 infections, even those with challenging comorbidities such as CKD or IBLD and in those receiving OAT.","['participants with comorbidities receiving EBR/GZR for 12 weeks in individual clinical trials (chronic kidney disease [CKD] stage 4/5, inherited blood disorders [IBLD', '1743 participants receiving', 'participants with and those without cirrhosis', 'enrolled adult participants with HCV infection']","['opioid agonist therapy [OAT', 'Direct-acting antiviral treatments', 'EBR/GZR plus ribavirin (RBV', 'elbasvir/grazoprevir', 'EBR/GZR', 'elbasvir/grazoprevir (EBR/GZR', 'placebo']","['headache', 'diarrhea', 'Safety and tolerability', 'Safety', 'fatigue', '≥1 adverse event (AE', 'IBLD or receiving OAT, safety', 'Grade 3/4 alanine aminotransferase elevations', 'nasopharyngitis', 'nausea']","[{'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C4080453', 'cui_str': 'elbasvir and grazoprevir'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0439660', 'cui_str': 'Hereditary'}, {'cui': 'C0018939', 'cui_str': 'Disorder of hematopoietic system'}, {'cui': 'C0023890', 'cui_str': 'Cirrhosis of liver'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0019196', 'cui_str': 'Viral hepatitis C'}]","[{'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0028753', 'cui_str': 'Oats'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C2363964', 'cui_str': 'Antiviral treatment'}, {'cui': 'C4080453', 'cui_str': 'elbasvir and grazoprevir'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0035525', 'cui_str': 'Ribavirin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0028753', 'cui_str': 'Oats'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0442757', 'cui_str': '3/4'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0027441', 'cui_str': 'Nasopharyngitis'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}]",1743.0,0.0643241,"EBR/GZR is a safe treatment option for individuals with HCV genotype (GT)1 or GT4 infections, even those with challenging comorbidities such as CKD or IBLD and in those receiving OAT.","[{'ForeName': 'Gayatri', 'Initials': 'G', 'LastName': 'Nangia', 'Affiliation': 'Department of Medicine, Division of Gastroenterology and Hepatology, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Vierling', 'Affiliation': 'Departments of Medicine and Surgery, Baylor College of Medicine, Houston, TX, USA.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Kwo', 'Affiliation': 'Department of Medicine-Gastroenterology and Hepatology, Stanford University School of Medicine, Palo Alto, CA, USA.'}, {'ForeName': 'Deborah D', 'Initials': 'DD', 'LastName': 'Brown', 'Affiliation': 'Merck & Co., Inc, Kenilworth, NJ, USA.'}, {'ForeName': 'Stephanie O', 'Initials': 'SO', 'LastName': 'Klopfer', 'Affiliation': 'Merck & Co., Inc, Kenilworth, NJ, USA.'}, {'ForeName': 'Michael N', 'Initials': 'MN', 'LastName': 'Robertson', 'Affiliation': 'Merck & Co., Inc, Kenilworth, NJ, USA.'}, {'ForeName': 'Barbara A', 'Initials': 'BA', 'LastName': 'Haber', 'Affiliation': 'Merck & Co., Inc, Kenilworth, NJ, USA.'}, {'ForeName': 'K Rajender', 'Initials': 'KR', 'LastName': 'Reddy', 'Affiliation': 'Department of Medicine, Division of Gastroenterology and Hepatology, University of Pennsylvania, Philadelphia, PA, USA.'}]",Journal of viral hepatitis,['10.1111/jvh.13357'] 2129,32594760,Two-hour infusion of vasoactive intestinal polypeptide induces delayed headache and extracranial vasodilation in healthy volunteers.,"BACKGROUND In recent years, vasoactive intestinal peptide (VIP) and pituitary adenylate cyclase-activating polypeptides (PACAPs) have gained special interest in headache science. VIP and PACAPs (two isoforms, PACAP27 and PACAP38) are related in structure and function, as are their receptors, but they show differences in vasodilating- and headache-inducing properties. Intravenous infusion of PACAP27 or PACAP38, but not VIP, induces a long-lasting dilation of cranial arteries and delayed headache. The relationship between the long-lasting cranial vasodilation and headache development is not fully clarified. METHODS In a double-blinded, placebo-controlled, crossover study in 12 healthy volunteers, diameter changes of cranial arteries, occurrence of headache and the parasympathetic system were examined before, during and after a 2-hour continuous intravenous infusion of VIP and placebo. Primary endpoints were the differences in area under the curve for the superficial temporal artery diameter and headache intensity scores, as well as in headache incidence, between VIP and placebo. RESULTS The superficial temporal artery diameter was significantly larger on the VIP day compared to placebo ( p  < 0.001) and the dilation lasted for more than 2 h. The incidence of headache was higher ( p  = 0.003) on the VIP day compared to the placebo day. The difference in headache intensity scores was more evident in the post-infusion period (120-200 min, p  = 0.034) and in the post-hospital phase (4-12 h, p  = 0.025). Cranial parasympathetic activity, measured through the production of tears, was higher during VIP compared to placebo ( p  = 0.033). CONCLUSION Continuous intravenous infusion of VIP over 2 h induced a long-lasting cranial vasodilation, activation of the cranial parasympathetic system, and delayed mild headaches in healthy volunteers. Trial Registration: The study is registered at ClinicalTrials.gov (NCT03989817).",2020,The superficial temporal artery diameter was significantly larger on the VIP day compared to placebo ( p  < 0.001) and the dilation lasted for more than 2 h.,"['healthy volunteers', '12 healthy volunteers, diameter changes of cranial arteries, occurrence of headache and the parasympathetic system']","['VIP and placebo', 'PACAP27 or PACAP38', 'vasoactive intestinal polypeptide', 'placebo']","['Cranial parasympathetic activity', 'delayed headache and extracranial vasodilation', 'superficial temporal artery diameter', 'headache intensity scores', 'incidence of headache', 'differences in area under the curve for the superficial temporal artery diameter and headache intensity scores, as well as in headache incidence, between VIP and placebo']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0037303', 'cui_str': 'Bone structure of cranium'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0042395', 'cui_str': 'vasoactive intestinal peptide'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0084057', 'cui_str': 'PACAP27'}, {'cui': 'C1314954', 'cui_str': 'PACAP38'}]","[{'cui': 'C0037303', 'cui_str': 'Bone structure of cranium'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0580586', 'cui_str': 'Extracranial'}, {'cui': 'C0042401', 'cui_str': 'Vasodilatation'}, {'cui': 'C0226130', 'cui_str': 'Structure of superficial temporal artery'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0042395', 'cui_str': 'vasoactive intestinal peptide'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",12.0,0.183353,The superficial temporal artery diameter was significantly larger on the VIP day compared to placebo ( p  < 0.001) and the dilation lasted for more than 2 h.,"[{'ForeName': 'Lanfranco', 'Initials': 'L', 'LastName': 'Pellesi', 'Affiliation': 'Danish Headache Center, Department of Neurology, Rigshospitalet Glostrup Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Mohammad Al-Mahdi', 'Initials': 'MA', 'LastName': 'Al-Karagholi', 'Affiliation': 'Danish Headache Center, Department of Neurology, Rigshospitalet Glostrup Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Basit Ali', 'Initials': 'BA', 'LastName': 'Chaudhry', 'Affiliation': 'Danish Headache Center, Department of Neurology, Rigshospitalet Glostrup Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Cristina Lopez', 'Initials': 'CL', 'LastName': 'Lopez', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Josefin', 'Initials': 'J', 'LastName': 'Snellman', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Hannibal', 'Affiliation': 'Department of Clinical Biochemistry, Bispebjerg Frederiksberg Hospital, Faculty of Health Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Faisal Mohammad', 'Initials': 'FM', 'LastName': 'Amin', 'Affiliation': 'Danish Headache Center, Department of Neurology, Rigshospitalet Glostrup Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Messoud', 'Initials': 'M', 'LastName': 'Ashina', 'Affiliation': 'Danish Headache Center, Department of Neurology, Rigshospitalet Glostrup Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}]",Cephalalgia : an international journal of headache,['10.1177/0333102420937655'] 2130,32585077,"""Patients are not the same, so we cannot treat them the same"" - A qualitative content analysis of provider, patient and implementer perspectives on differentiated service delivery models for HIV treatment in South Africa.","INTRODUCTION In 2014, the South African government adopted a differentiated service delivery (DSD) model in its ""National Adherence Guidelines for Chronic Diseases (HIV, TB and NCDs)"" (AGL) to strengthen the HIV care cascade. We describe the barriers and facilitators of the AGL implementation as experienced by various stakeholders in eight intervention and control sites across four districts. METHODS Embedded within a cluster-randomized evaluation of the AGL, we conducted 48 in-depth interviews (IDIs) with healthcare providers, 16 IDIs with Department of Health and implementing partners and 24 focus group discussions (FGDs) with three HIV patient groups: new, stable and those not stable on treatment or not adhering to care. IDIs were conducted from August 2016 to August 2017; FGDs were conducted in January to February 2017. Content analysis was guided by the Consolidated Framework for Implementation Research. Findings were triangulated among respondent types to elicit barriers and facilitators to implementation. RESULTS New HIV patients found counselling helpful but intervention respondents reported sub-optimal counselling and privacy concerns as barriers to initiation. Providers felt insufficiently trained for this intervention and were confused by the simultaneous rollout of the Universal Test and Treat strategy. For stable patients, repeat prescription collection strategies (RPCS) were generally well received. Patients and providers concurred that RPCS reduced congestion and waiting times at clinics. There was confusion though, among providers and implementers, around implementation of RPCS interventions. For patients not stable on treatment, enhanced counselling and tracing patients lost-to-follow-up were perceived as beneficial to adherence behaviours but faced logistical challenges. All providers faced difficulties accessing data and identifying patients in need of tracing. Congestion at clinics and staff attitude were perceived as barriers preventing patients returning to care. CONCLUSIONS Implementation of DSD models at scale is complex but this evaluation identified several positive aspects of AGL implementation. The positive perception of RPCS interventions and challenges managing patients not stable on treatment aligned with results from the larger evaluation. While some implementation challenges may resolve with experience, ensuring providers and implementers have the necessary training, tools and resources to operationalize AGL effectively is critical to the overall success of South Africa's HIV control strategy.",2020,"For patients not stable on treatment, enhanced counselling and tracing patients lost-to-follow-up were perceived as beneficial to adherence behaviours but faced logistical challenges.","['IDIs were conducted from August 2016 to August 2017; FGDs were conducted in January to February 2017', '48 in-depth interviews (IDIs) with healthcare providers, 16 IDIs with Department of Health and implementing partners and 24 focus group discussions (FGDs) with three HIV patient groups']","['AGL', 'new, stable and those not stable on treatment or not adhering to care']",['congestion and waiting times'],"[{'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0016400', 'cui_str': 'Focus Groups'}, {'cui': 'C0557061', 'cui_str': 'Discussion'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0700148', 'cui_str': 'Congestion'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",,0.0350601,"For patients not stable on treatment, enhanced counselling and tracing patients lost-to-follow-up were perceived as beneficial to adherence behaviours but faced logistical challenges.","[{'ForeName': 'Sophie J S', 'Initials': 'SJS', 'LastName': 'Pascoe', 'Affiliation': 'Health Economics and Epidemiology Research Office, Department of Internal Medicine, School of Clinical Medicine, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Nancy A', 'Initials': 'NA', 'LastName': 'Scott', 'Affiliation': 'Department of Global Health, Boston University School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Rachel M', 'Initials': 'RM', 'LastName': 'Fong', 'Affiliation': 'Department of Global Health, Boston University School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Murphy', 'Affiliation': 'Health Economics and Epidemiology Research Office, Department of Internal Medicine, School of Clinical Medicine, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Amy N', 'Initials': 'AN', 'LastName': 'Huber', 'Affiliation': 'Health Economics and Epidemiology Research Office, Department of Internal Medicine, School of Clinical Medicine, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Aneesa', 'Initials': 'A', 'LastName': 'Moolla', 'Affiliation': 'Health Economics and Epidemiology Research Office, Department of Internal Medicine, School of Clinical Medicine, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Mokgadi', 'Initials': 'M', 'LastName': 'Phokojoe', 'Affiliation': 'National Department of Health, Pretoria, South Africa.'}, {'ForeName': 'Marelize', 'Initials': 'M', 'LastName': 'Gorgens', 'Affiliation': 'The World Bank Group, Washington, DC, USA.'}, {'ForeName': 'Sydney', 'Initials': 'S', 'LastName': 'Rosen', 'Affiliation': 'Health Economics and Epidemiology Research Office, Department of Internal Medicine, School of Clinical Medicine, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Wilson', 'Affiliation': 'The World Bank Group, Washington, DC, USA.'}, {'ForeName': 'Yogan', 'Initials': 'Y', 'LastName': 'Pillay', 'Affiliation': 'National Department of Health, Pretoria, South Africa.'}, {'ForeName': 'Matthew P', 'Initials': 'MP', 'LastName': 'Fox', 'Affiliation': 'Health Economics and Epidemiology Research Office, Department of Internal Medicine, School of Clinical Medicine, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Fraser-Hurt', 'Affiliation': 'The World Bank Group, Washington, DC, USA.'}]",Journal of the International AIDS Society,['10.1002/jia2.25544'] 2131,32586293,"A blended intervention to promote physical activity, health and work productivity among office employees using intervention mapping: a study protocol for a cluster-randomized controlled trial.","BACKGROUND Regular participation in moderate-to-vigorous physical activity (MVPA) is related to decreased risk of morbidity and mortality. Among working populations, lack of MVPA may also be a risk factor for absenteeism and presenteeism. Both traditional workplace-based and web-based interventions have been suggested as being effective in promoting participation MVPA, health-related outcomes, and work-related productivity. However, several challenges limit their application in real world contexts. A 'blended' intervention approach combining the two intervention strategies is proposed to overcome these limitations. The proposed intervention aims to utilize the blended approach to increase participation in MVPA, health-related outcomes, and work productivity among inactive workers. METHODS The study will comprise of a three-group cluster randomized controlled trial (cluster-RCT), comprising a three-month actual intervention and a nine-month behavioral follow-up period. The three groups will be: a web-based intervention group, a blended intervention group combining the web-based components with face-to-face workshops and posters, and a control group. Physically inactive office employees (N = 495) from 33 companies (i.e., clusters) will be recruited and randomly assigned to the three groups by cluster randomization. The intervention mapping (IM) framework will be used for selecting and applying effective health behavioral theories and behavioral change techniques (BCTs) to the development, implementation and assessment of the intervention, which will be personally tailored. The primary outcome variable will be objectively-measured MVPA using an accelerometer. Secondary outcomes will consist of indices of health including adiposity, blood pressure, blood sugar, blood lipids, self-reported depression, anxiety, stress, health-related quality of life and work-related variables including absenteeism and presenteeism. DISCUSSION The proposed study adopts a robust blended intervention approach that is expected to overcome challenges in applying workplace-based and web-based interventions separately and yield larger effects in promoting MVPA participation, health-related outcomes and work productivity. Improvements in work productivity outcomes will be of particular interest to employers. If more effective, the new blended intervention has the potential to be implemented on a larger scale to benefit workplace populations. TRIAL REGISTRATION The trial is prospectively registered at the ClinicalTrials.gov PRS (Trial ID: NCT04391270; Date of First Posted: May 18, 2020).",2020,"Both traditional workplace-based and web-based interventions have been suggested as being effective in promoting participation MVPA, health-related outcomes, and work-related productivity.","['Physically inactive office employees (N\u2009=\u2009495) from 33 companies (i.e., clusters']","['blended intervention group combining the web-based components with face-to-face workshops and posters, and a control group']","['consist of indices of health including adiposity, blood pressure, blood sugar, blood lipids, self-reported depression, anxiety, stress, health-related quality of life and work-related variables including absenteeism and presenteeism', 'objectively-measured MVPA using an accelerometer']","[{'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C0599987', 'cui_str': 'Employee'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0242262', 'cui_str': 'Workshops'}, {'cui': 'C0376675', 'cui_str': 'Posters'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0000849', 'cui_str': 'Absenteeism'}, {'cui': 'C4042785', 'cui_str': 'Sickness Presence'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",,0.0879274,"Both traditional workplace-based and web-based interventions have been suggested as being effective in promoting participation MVPA, health-related outcomes, and work-related productivity.","[{'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'Department of Sport, Physical Education and Health, Hong Kong Baptist University, Hong Kong, China.'}, {'ForeName': 'Aiwei', 'Initials': 'A', 'LastName': 'Wang', 'Affiliation': 'Department of Sport, Physical Education and Health, Hong Kong Baptist University, Hong Kong, China.'}, {'ForeName': 'Siyue', 'Initials': 'S', 'LastName': 'Yu', 'Affiliation': 'JC School of Public Health and Primary Care, The Chinese University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Martin S', 'Initials': 'MS', 'LastName': 'Hagger', 'Affiliation': 'Psychological Sciences, University of California, Merced, CA, USA.'}, {'ForeName': 'Xiangyan', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': 'Department of Health Technology and Informatics, The Hong Kong Polytechnic University, Hong Kong, China.'}, {'ForeName': 'Shirley Siu Ming', 'Initials': 'SSM', 'LastName': 'Fong', 'Affiliation': 'Department of Health and Physical Education, Education University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Chunqing', 'Initials': 'C', 'LastName': 'Zhang', 'Affiliation': 'Department of Sport, Physical Education and Health, Hong Kong Baptist University, Hong Kong, China.'}, {'ForeName': 'Wendy Yajun', 'Initials': 'WY', 'LastName': 'Huang', 'Affiliation': 'Department of Sport, Physical Education and Health, Hong Kong Baptist University, Hong Kong, China.'}, {'ForeName': 'Julien S', 'Initials': 'JS', 'LastName': 'Baker', 'Affiliation': 'Department of Sport, Physical Education and Health, Hong Kong Baptist University, Hong Kong, China.'}, {'ForeName': 'Frédéric', 'Initials': 'F', 'LastName': 'Dutheil', 'Affiliation': 'LaPSCo, Physiological and Psychosocial Stress, CHU Clermont-Ferrand, Preventive and Occupational Medicine, Witty Fit, University Hospital of Clermont-Ferrand, F-63000, Clermont-Ferrand, France.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Gao', 'Affiliation': 'Department of Sport, Physical Education and Health, Hong Kong Baptist University, Hong Kong, China. gaoyang@hkbu.edu.hk.'}]",BMC public health,['10.1186/s12889-020-09128-z'] 2132,32586344,"FASCE, the benefit of spironolactone for treating acne in women: study protocol for a randomized double-blind trial.","BACKGROUND Acne vulgaris has increased in women over the past 10 years; it currently affects 20-30% of women. The physiopathology of adult female acne is distinguished from that of teenagers essentially by two factors: hormonal and inflammatory. On a therapeutic plan, the four types of systemic treatment approved for female acne include cyclines (leading to bacterial resistance); zinc salts (less effective than cyclines); and antiandrogens (risks of phlebitis). The last alternative is represented by isotretinoin, but its use in women of childbearing potential is discouraged because of the teratogen risks. In this context, spironolactone could represent an interesting alternative. It blocks the 5-alpha-reductase receptors at the sebaceous gland and inhibits luteinizing hormone (LH) production at the pituitary level. It has no isotretinoin constraints and does not lead to bacterial resistance. Currently, very few studies have been performed in a limited number of patients: the studies showed that at low doses (lower than 200 mg/day), spironolactone can be effective against acne. In that context, it is clearly of interest to perform the first double-blind randomized study of spironolactone versus cyclines, which remains the moderate acne reference treatment, and to demonstrate the superiority of spironolactone's efficacy in order to establish it as an alternative to cyclines. METHODS Two hundred female patients will be included. They must have acne vulgaris with at least 10 inflammatory lesions and no more than 3 nodules. After randomization, the patients will be treated by spironolactone or doxycycline for 3 months and after placebo. The study will be blind for the first 6 months and open for the last 6 months. DISCUSSION The treatment frequently used in female acne is systemic antibiotics with many courses, as it is a chronic inflammatory disease. In the context of the recent World Health Organisation (WHO) revelation about the serious, worldwide threat to public health of antibiotic resistance, this trial could give the physician another alternative in the treatment of adult female acne instead of using isotretinoin, which is more complex to manage. TRIAL REGISTRATION ClinicalTrials.gov: NCT03334682. Registered on 7 November 2017.",2020,"In the context of the recent World Health Organisation (WHO) revelation about the serious, worldwide threat to public health of antibiotic resistance, this trial could give the physician another alternative in the treatment of adult female acne instead of using isotretinoin, which is more complex to manage. ","['Two hundred female patients will be included', 'women']","['FASCE', 'spironolactone or doxycycline', 'spironolactone', 'placebo']",[],"[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0037982', 'cui_str': 'Spironolactone'}, {'cui': 'C0013090', 'cui_str': 'Doxycycline'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],200.0,0.134613,"In the context of the recent World Health Organisation (WHO) revelation about the serious, worldwide threat to public health of antibiotic resistance, this trial could give the physician another alternative in the treatment of adult female acne instead of using isotretinoin, which is more complex to manage. ","[{'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Poinas', 'Affiliation': 'Clinical Investigation Centre CIC1413, CHU Nantes and INSERM, Nantes, France. alexandra.poinas@chu-nantes.fr.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Lemoigne', 'Affiliation': 'Dermatology Department, CHU Nantes, Nantes University, CRCINA, Nantes, France.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Le Naour', 'Affiliation': 'Dermatology Department, CHU Nantes, Nantes University, CRCINA, Nantes, France.'}, {'ForeName': 'Jean-Michel', 'Initials': 'JM', 'LastName': 'Nguyen', 'Affiliation': 'Department of Epidemiology and Biostatistics, CHU Nantes, Nantes, France.'}, {'ForeName': 'Solène', 'Initials': 'S', 'LastName': 'Schirr-Bonnans', 'Affiliation': 'Service Evaluation Economique et Développement des Produits de Santé, Département Partenariats et Innovation, Centre Hospitalier Universitaire de Nantes, Nantes University, Nantes, France.'}, {'ForeName': 'Valery-Pierre', 'Initials': 'VP', 'LastName': 'Riche', 'Affiliation': 'Service Evaluation Economique et Développement des Produits de Santé, Département Partenariats et Innovation, Centre Hospitalier Universitaire de Nantes, Nantes University, Nantes, France.'}, {'ForeName': 'Florence', 'Initials': 'F', 'LastName': 'Vrignaud', 'Affiliation': 'Clinical Investigation Centre CIC1413, CHU Nantes and INSERM, Nantes, France.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Machet', 'Affiliation': 'Department of Dermatology, CHU Tours, INSERM U1253, University of Tours, Tours, France.'}, {'ForeName': 'Jean-Paul', 'Initials': 'JP', 'LastName': 'Claudel', 'Affiliation': 'Private Practice, Tours, France.'}, {'ForeName': 'Marie-Thérèse', 'Initials': 'MT', 'LastName': 'Leccia', 'Affiliation': 'Department of Dermatology, Allergology and Photobiology, CHU A. Michallon, Grenoble, France.'}, {'ForeName': 'Ewa', 'Initials': 'E', 'LastName': 'Hainaut', 'Affiliation': 'Service de Dermatologie, Poitiers University Hospital, Poitiers, France.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Beneton', 'Affiliation': 'Service de Dermatologie, Le Mans Hospital, Le Mans, France.'}, {'ForeName': 'Cécile', 'Initials': 'C', 'LastName': 'Dert', 'Affiliation': 'Service Evaluation Economique et Développement des Produits de Santé, Département Partenariats et Innovation, Centre Hospitalier Universitaire de Nantes, Nantes University, Nantes, France.'}, {'ForeName': 'Aurélie', 'Initials': 'A', 'LastName': 'Boisrobert', 'Affiliation': 'Clinical Investigation Centre CIC1413, CHU Nantes and INSERM, Nantes, France.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Flet', 'Affiliation': 'Department of Pharmacy, CHU Nantes, Nantes, France.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Chiffoleau', 'Affiliation': 'Direction de la Recherche, Département Promotion, Cellule Vigilances, Centre Hospitalier Universitaire de Nantes, Nantes, France.'}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Corvec', 'Affiliation': 'CHU Nantes, Service de Bactériologie-Hygiène Hospitalière, CRCINA, INSERM, U1232, Université de Nantes, Nantes, France.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Khammari', 'Affiliation': 'Clinical Investigation Centre CIC1413, CHU Nantes and INSERM, Nantes, France.'}, {'ForeName': 'Brigitte', 'Initials': 'B', 'LastName': 'Dréno', 'Affiliation': 'Clinical Investigation Centre CIC1413, CHU Nantes and INSERM, Nantes, France.'}]",Trials,['10.1186/s13063-020-04432-w'] 2133,32586348,"Postoperative analgesia of scalp nerve block with ropivacaine in pediatric craniotomy patients: a protocol for a prospective, randomized, placebo-controlled, double-blinded trial.","BACKGROUND Moderate-to-severe postoperative pain following craniotomy has a high incidence in pediatric patients. Such pain may cause agitation, intracranial hypertension, epileptic seizures, and postoperative hematoma, which affect morbidity and mortality. Although scalp nerve block (SNB) achieves satisfactory pain relief except for suboccipital mid-craniotomy in adults and ropivacaine is widely used as a long-acting peripheral nerve block agent in children, there are few studies of SNB with ropivacaine in pediatric patients undergoing craniotomy. In addition, the neurosurgery operation time is relatively long, but the duration of action of SNB is limited. It is generally believed that postoperative SNB is better than preoperative SNB for postoperative analgesia. However, considering the concept of preemptive analgesia, we believe that preoperative SNB may achieve a longer postoperative analgesia effect than we expected. METHODS This trial is a single-institution, prospective, randomized, controlled, double-blind study. A total of 180 children aged between 1 and 12 years who are undergoing elective craniotomy will be randomly allocated in a 1:1:1 ratio to three groups: group B (preoperative ropivacaine block group), group A (postoperative ropivacaine block group), and group N (nonblocking control group). This randomization will be stratified by age in two strata (1-6 years and 7-12 years). The primary outcome is the total consumption of sufentanil within 24 h after surgery. The secondary outcomes include assessment of pain scores, total consumption of sufentanil and emergency-remedy medicine consumption at observation points, the occurrence of postoperative complications, and the length of hospitalization after surgery. DISCUSSION This study is designed to explore the effect and feasibility of SNB with ropivacaine for postoperative analgesia in pediatric patients undergoing craniotomy. Further aims are to compare the effects of preoperative and postoperative SNB on postoperative analgesia in order to identify whether there is a preemptive analgesic effect and determine the better time to implement SNB in pediatric patients during craniotomy. TRIAL REGISTRATION Chinese Clinical Trial Registry ChiCTR1800017386. Registered on 27 July 2018.",2020,"Although scalp nerve block (SNB) achieves satisfactory pain relief except for suboccipital mid-craniotomy in adults and ropivacaine is widely used as a long-acting peripheral nerve block agent in children, there are few studies of SNB with ropivacaine in pediatric patients undergoing craniotomy.","['180 children aged between 1 and 12\u2009years who are undergoing elective craniotomy', 'pediatric patients', 'pediatric patients during craniotomy', 'pediatric patients undergoing craniotomy', 'pediatric craniotomy patients']","['ropivacaine block group), group A (postoperative ropivacaine block group), and group N (nonblocking control group', 'scalp nerve block (SNB', 'ropivacaine', 'SNB', 'placebo']","['postoperative analgesia effect', 'assessment of pain scores, total consumption of sufentanil and emergency-remedy medicine consumption at observation points, the occurrence of postoperative complications, and the length of hospitalization after surgery', 'total consumption of sufentanil within 24\u2009h after surgery']","[{'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0010280', 'cui_str': 'Craniotomy'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0441848', 'cui_str': 'Group N'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0036270', 'cui_str': 'Scalp structure'}, {'cui': 'C0027741', 'cui_str': 'Nerve block'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0143993', 'cui_str': 'Sufentanil'}, {'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C0920324', 'cui_str': 'Homeopathic medicine'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}]",180.0,0.390615,"Although scalp nerve block (SNB) achieves satisfactory pain relief except for suboccipital mid-craniotomy in adults and ropivacaine is widely used as a long-acting peripheral nerve block agent in children, there are few studies of SNB with ropivacaine in pediatric patients undergoing craniotomy.","[{'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Xiong', 'Affiliation': 'Department of Anesthesiology, Beijing Tiantan Hospital, Capital Medical University, Beijing, 100070, China.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Department of Anesthesiology, Beijing Tiantan Hospital, Capital Medical University, Beijing, 100070, China.'}, {'ForeName': 'Di', 'Initials': 'D', 'LastName': 'Bao', 'Affiliation': 'Department of Anesthesiology, Beijing Tiantan Hospital, Capital Medical University, Beijing, 100070, China.'}, {'ForeName': 'Yaxin', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, Beijing Tiantan Hospital, Capital Medical University, Beijing, 100070, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Liang', 'Affiliation': 'Department of Anesthesiology, Beijing Tiantan Hospital, Capital Medical University, Beijing, 100070, China.'}, {'ForeName': 'Pengwei', 'Initials': 'P', 'LastName': 'Lu', 'Affiliation': 'Department of Neurosurgery, Beijing Tiantan Hospital, Capital Medical University, Beijing, 100070, China.'}, {'ForeName': 'Di', 'Initials': 'D', 'LastName': 'Zhang', 'Affiliation': 'Department of Anesthesiology, Beijing Tiantan Hospital, Capital Medical University, Beijing, 100070, China.'}, {'ForeName': 'Gaifen', 'Initials': 'G', 'LastName': 'Liu', 'Affiliation': 'Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, 100070, China.'}, {'ForeName': 'Lanxin', 'Initials': 'L', 'LastName': 'Qiao', 'Affiliation': 'Department of Anesthesiology, Beijing Tiantan Hospital, Capital Medical University, Beijing, 100070, China.'}, {'ForeName': 'Na', 'Initials': 'N', 'LastName': 'Zheng', 'Affiliation': 'Department of Anesthesiology, Beijing Tiantan Hospital, Capital Medical University, Beijing, 100070, China.'}, {'ForeName': 'Xu', 'Initials': 'X', 'LastName': 'Jin', 'Affiliation': 'Department of Anesthesiology, Beijing Tiantan Hospital, Capital Medical University, Beijing, 100070, China. jxsys2020@gmail.com.'}]",Trials,['10.1186/s13063-020-04524-7'] 2134,32586349,Core outcome sets through the healthcare ecosystem: the case of type 2 diabetes mellitus.,"BACKGROUND It is increasingly accepted that insufficient attention has been given to the patient health outcomes that are important to measure in comparative effectiveness research that will inform decision-making. The relationship between outcomes chosen for comparative effectiveness research, outcomes used in decision-making in routine care, and outcome data recorded in electronic health records (EHR) is also poorly understood. The COMET Initiative (http://www.comet-initiative.org/. Accessed 3 Apr 2020) supports and encourages the development and use of 'core outcome sets' (COS), which represent the minimum set of patient health outcomes that should be measured and reported for a specific condition. There is growing interest in identifying how COS might fit into the different stages of the healthcare research and delivery ecosystem, and whether inclusion in the EHR might facilitate this. METHODS We sought to determine the degree of overlap between outcomes within COS for research and routine care, EMA, FDA and NICE guidelines, NICE quality statements/indicators, EHR and a point-of-care randomised clinical trial, using type 2 diabetes (T2D) as a case study. RESULTS There is substantial agreement about important patient outcomes for T2D for research and healthcare, with associated coverage within the UK general practice EHR. CONCLUSIONS This case study has demonstrated the potential for efficient research and value-based healthcare when the EHR can include COS for both research and care, where the COS comprises outcomes of importance to all relevant stakeholders. However, this concordance may not hold more generally, as the focus on patient-centred outcomes may well be greater in T2D than in other conditions. Work is ongoing to examine other clinical areas, in order to highlight any current inefficiencies when health outcomes in research and healthcare do not agree with core outcomes identified by patients, clinicians and other key stakeholders.",2020,"There is substantial agreement about important patient outcomes for T2D for research and healthcare, with associated coverage within the UK general practice EHR. ",[],[],[],[],[],[],,0.0462693,"There is substantial agreement about important patient outcomes for T2D for research and healthcare, with associated coverage within the UK general practice EHR. ","[{'ForeName': 'Susanna', 'Initials': 'S', 'LastName': 'Dodd', 'Affiliation': 'Department of Health Data Science, University of Liverpool (a member of Liverpool Health Partners), Liverpool, UK. s.r.dodd@liv.ac.uk.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Harman', 'Affiliation': 'Department of Health Data Science, University of Liverpool (a member of Liverpool Health Partners), Liverpool, UK.'}, {'ForeName': 'Nichole', 'Initials': 'N', 'LastName': 'Taske', 'Affiliation': 'NICE Centre for Guidelines/Quality and Leadership Programme, Manchester, UK.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Minchin', 'Affiliation': 'NICE Centre for Guidelines/Quality and Leadership Programme, Manchester, UK.'}, {'ForeName': 'Toni', 'Initials': 'T', 'LastName': 'Tan', 'Affiliation': 'NICE Centre for Guidelines/Quality and Leadership Programme, Manchester, UK.'}, {'ForeName': 'Paula R', 'Initials': 'PR', 'LastName': 'Williamson', 'Affiliation': 'Department of Health Data Science, University of Liverpool (a member of Liverpool Health Partners), Liverpool, UK.'}]",Trials,['10.1186/s13063-020-04403-1'] 2135,32589073,"Comparison of the efficacy and safety of CELBESTA® versus CELEBREX® in patients with rheumatoid arthritis: a 6-week, multicenter, double-blind, double-dummy, active-controlled, randomized, parallel-group, non-inferiority phase 4 clinical trial.","OBJECTIVES Celecoxib is a selective cyclooxygenase (COX)-2 inhibitor that is commonly used to reduce the incidence of gastrointestinal (GI) complications in patients with rheumatoid arthritis (RA). CELBESTA® is a generic equivalent to CELEBREX®, a celecoxib preparation. This study compared the efficacy and safety of CELBESTA® and CELEBREX® in patients with RA. METHODS This was a multicenter, double-blind, double-dummy, active-controlled, randomized, parallel-group, non-inferiority clinical trial. The primary endpoint was a change from baseline in self-assessed pain intensity determined using a 100-mm visual analog scale after 6 weeks of treatment. RESULTS After a washout period, 119 eligible subjects were randomized to one of two groups (CELBESTA® group, n = 61; CELEBREX® group, n = 58). CELBESTA® was not inferior to CELEBREX® because the upper limit of two-sided 95% confidence interval (CI) for the difference between the two groups (difference in the least square [LS] mean, -8.68 mm; two-sided 95% CI -16.59 mm to -0.77 mm) was less than the non-inferiority margin (10 mm). There were no significant differences in GI complications and renal toxicity. CONCLUSIONS CELBESTA® was not inferior to CELEBREX® with regard to the pain relief efficacy in RA patients, and the tolerability and safety profiles were excellent and at similar levels for both preparations.",2020,"CONCLUSIONS CELBESTA® was not inferior to CELEBREX® with regard to the pain relief efficacy in RA patients, and the tolerability and safety profiles were excellent and at similar levels for both preparations.","['patients with rheumatoid arthritis', 'patients with rheumatoid arthritis (RA', 'patients with RA', '119 eligible subjects']","['CELBESTA® versus CELEBREX®', 'CELBESTA® and CELEBREX®', 'Celecoxib']","['incidence of gastrointestinal (GI) complications', 'GI complications and renal toxicity', 'efficacy and safety', 'change from baseline in self-assessed pain intensity determined using a 100-mm visual analog scale', 'tolerability and safety profiles', 'pain relief efficacy']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}]","[{'cui': 'C0719198', 'cui_str': 'Celebrex'}, {'cui': 'C0538927', 'cui_str': 'celecoxib'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0161819', 'cui_str': 'Gastrointestinal complication'}, {'cui': 'C0595916', 'cui_str': 'Toxic nephropathy'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}]",119.0,0.734665,"CONCLUSIONS CELBESTA® was not inferior to CELEBREX® with regard to the pain relief efficacy in RA patients, and the tolerability and safety profiles were excellent and at similar levels for both preparations.","[{'ForeName': 'Hyun-Sook', 'Initials': 'HS', 'LastName': 'Kim', 'Affiliation': 'Division of Rheumatology, Department of Internal Medicine, Soonchunhyang University Seoul Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Won-Ho', 'Initials': 'WH', 'LastName': 'Choi', 'Affiliation': 'Division of Rheumatology, Department of Internal Medicine, Soonchunhyang University Seoul Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Bo Young', 'Initials': 'BY', 'LastName': 'Kim', 'Affiliation': 'Division of Rheumatology, Department of Internal Medicine, Gangneung Asan Hospital, Ulsan University College of Medicine, Gangneung, Republic of Korea.'}, {'ForeName': 'Sung Soo', 'Initials': 'SS', 'LastName': 'Kim', 'Affiliation': 'Division of Rheumatology, Department of Internal Medicine, Gangneung Asan Hospital, Ulsan University College of Medicine, Gangneung, Republic of Korea.'}, {'ForeName': 'Sang-Il', 'Initials': 'SI', 'LastName': 'Lee', 'Affiliation': 'Division of Rheumatology, Department of Internal Medicine, Gyeongsang National University Hospital, JinJu, Republic of Korea.'}, {'ForeName': 'Sang-Hyon', 'Initials': 'SH', 'LastName': 'Kim', 'Affiliation': 'Division of Rheumatology, Department of Internal Medicine, Keimyung University Dongsan Medical Center, Daegu, Republic of Korea.'}, {'ForeName': 'Sung Jae', 'Initials': 'SJ', 'LastName': 'Choi', 'Affiliation': 'Division of Rheumatology, Department of Internal Medicine, Korea University Ansan Hospital, Ansan, Republic of Korea.'}, {'ForeName': 'Geun-Tae', 'Initials': 'GT', 'LastName': 'Kim', 'Affiliation': 'Division of Rheumatology, Department of Internal Medicine, Kosin University Gospel Hospital, Busan, Republic of Korea.'}, {'ForeName': 'Jin-Wuk', 'Initials': 'JW', 'LastName': 'Hur', 'Affiliation': 'Division of Rheumatology, Department of Internal Medicine, Nowon Eulji Medical Center, Seoul, Republic of Korea.'}, {'ForeName': 'Myeung-Su', 'Initials': 'MS', 'LastName': 'Lee', 'Affiliation': 'Division of Rheumatology, Department of Internal Medicine, Wonkwang University Hospital, Iksan, Republic of Korea.'}, {'ForeName': 'Yun Sung', 'Initials': 'YS', 'LastName': 'Kim', 'Affiliation': 'Division of Rheumatology, Department of Internal Medicine, Chosun University Hospital, Gwangju, Republic of Korea.'}, {'ForeName': 'Seung-Jae', 'Initials': 'SJ', 'LastName': 'Hong', 'Affiliation': 'Division of Rheumatology, Department of Internal Medicine, Kyung Hee University Medical Center, Seoul, Republic of Korea.'}]",The Journal of international medical research,['10.1177/0300060520931323'] 2136,32589129,"Prospective partially randomized comparison of clopidogrel loading versus maintenance dosing to prevent periprocedural myocardial infarction after stenting for stable angina pectoris: Results from the ""Method of Clopidogrel Pre-treatment Undergoing Conventional Coronary Angiogram in Angina Patients (MECCA)"" study.","WHAT IS KNOWN AND OBJECTIVE Pre-treatment of clopidogrel 600 mg is better than 300 mg loading for reducing periprocedural myocardial infarction (PMI). We aimed to evaluate pre-treatment methods for preventing PMI among patients undergoing conventional coronary angiography (CAG) for stable angina pectoris. MATERIALS AND METHODS The study analyzed 402 patients who underwent percutaneous coronary intervention (PCI) during 2010 - 2011 at three Korean hospitals. Clopidogrel-naïve patients received routine maintenance therapy (75 mg/day for ≥ 5 days) and were randomly assigned to a 300-mg reload (RL) or only the maintenance dose (MD). Patients who received a loading dose (LD; 600 mg at 2 - 24 hours before the procedure) were entered into a non-randomized group. RESULTS After excluding patients who showed an abnormal creatinine kinase myocardial band (CK-MB) level, the study included 233 patients in the LD group, 85 patients in the RL group and 84 patients in the MD group. The LD group had a significantly higher rate of PMI (LD: 21, RL: 3, MD: 0 cases; p = 0.007) and a significant increase in the mean CK-MB levels after 8 hours (p = 0.016) and 24 h (p = 0.01). However, there was no difference in PMI between the RL and MD groups. Furthermore, no significant differences between the three groups were observed in the P2Y12 reaction unit (PRU) values (p = 0.57). Albeit not significantly, the LD group had a higher rate of moderate-to-severe GUSTO bleeding within 7 days. WHAT IS NEW AND CONCLUSION Clopidogrel maintenance is better than 600-mg loading for preventing PMI, and the RL protocol did not further prevent PMI.
.",2020,"Albeit not significantly, the LD group had a higher rate of moderate-to-severe GUSTO bleeding within 7 days. ","['233 patients in the LD group, 85 patients in the RL group and 84 patients in the MD group', 'patients undergoing', '402 patients who underwent percutaneous coronary intervention (PCI) during 2010\xa0-\xa02011 at three Korean hospitals', 'stable angina pectoris']","['clopidogrel loading', 'conventional coronary angiography (CAG', '300-mg reload (RL) or only the maintenance dose (MD', 'clopidogrel', 'Clopidogrel-naïve patients received routine maintenance therapy', 'Clopidogrel Pre-treatment Undergoing Conventional Coronary Angiogram']","['rate of PMI', 'rate of moderate-to-severe GUSTO bleeding', 'periprocedural myocardial infarction', 'P2Y12 reaction unit (PRU) values', 'periprocedural myocardial infarction (PMI', 'mean CK-MB levels', 'PMI', 'abnormal creatinine kinase myocardial band (CK-MB) level']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0340288', 'cui_str': 'Stable angina'}]","[{'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0085532', 'cui_str': 'Coronary angiography'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C3714445', 'cui_str': 'Maintenance dose'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0677908', 'cui_str': 'Maintenance therapy'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C4324584', 'cui_str': 'Periprocedural myocardial infarction'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0031727', 'cui_str': 'Kinase'}, {'cui': 'C0175723', 'cui_str': 'Band'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0740471', 'cui_str': 'Creatinine abnormal NOS'}]",233.0,0.0456417,"Albeit not significantly, the LD group had a higher rate of moderate-to-severe GUSTO bleeding within 7 days. ","[{'ForeName': 'Jae Hyoung', 'Initials': 'JH', 'LastName': 'Park', 'Affiliation': ''}, {'ForeName': 'Je Sang', 'Initials': 'JS', 'LastName': 'Kim', 'Affiliation': ''}, {'ForeName': 'Chul-Min', 'Initials': 'CM', 'LastName': 'Ahn', 'Affiliation': ''}, {'ForeName': 'Soon Jun', 'Initials': 'SJ', 'LastName': 'Hong', 'Affiliation': ''}, {'ForeName': 'Kyung Joo', 'Initials': 'KJ', 'LastName': 'Ahn', 'Affiliation': ''}, {'ForeName': 'Jae Woong', 'Initials': 'JW', 'LastName': 'Choi', 'Affiliation': ''}, {'ForeName': 'Hyung Joon', 'Initials': 'HJ', 'LastName': 'Joo', 'Affiliation': ''}, {'ForeName': 'Cheol Woong', 'Initials': 'CW', 'LastName': 'Yu', 'Affiliation': ''}, {'ForeName': 'Do-Sun', 'Initials': 'DS', 'LastName': 'Lim', 'Affiliation': ''}]",International journal of clinical pharmacology and therapeutics,['10.5414/CP203644'] 2137,32584893,Effectiveness of a digital device providing real-time visualized tooth brushing instructions: A randomized controlled trial.,"INTRODUCTION The aim of this trial was to investigate whether a digital device that provides real-time visualized brushing instructions would contribute to the removal of dental plaque over usual brushing instructions. METHODS We conducted a single-center, parallel-group, stratified permuted block randomized control trial with 1:1 allocation ratio. Eligibility criteria included people aged ≥ 18 years, and exclude people who met the following criteria: severely crowded teeth; using interdental cleaning implement; having external injury in the oral cavity, or stomatitis; having less than 20 teeth; using orthodontic apparatus; visited to a dental clinic; having the possibility of consulting a dental clinic; having a dental license; not owning a smartphone or tablet device; smoker; taken antibiotics; pregnant; an allergy to the staining fluid; and employee of Sunstar Inc. All participants received tooth brushing instructions using video materials and were randomly assigned to one of two groups for four weeks: (1) an intervention group who used the digital device, providing real-time visualized instructions by connection with a mobile application; and (2) a control group that used a digital device which only collected their brushing logs. The primary outcome was the change in 6-point method plaque control record (PCR) score of all teeth between baseline and week 4. The t-test was used to compare the two groups in accordance with intention-to-treat principles. RESULTS Among 118 enrolled individuals, 112 participants were eligible for our analyses. The mean of PCR score at week 4 was 45.05% in the intervention group and 49.65% in the control group, and the change of PCR score from baseline was -20.46% in the intervention group and -15.77% in the control group (p = 0.088, 95% confidence interval -0.70-10.07). CONCLUSIONS A digital device providing real-time visualized brushing instructions may be effective for the removal of dental plaque.",2020,"The mean of PCR score at week 4 was 45.05% in the intervention group and 49.65% in the control group, and the change of PCR score from baseline was -20.46% in the intervention group and -15.77% in the control group (p = 0.088, 95% confidence interval -0.70-10.07). ","['118 enrolled individuals', '112 participants were eligible for our analyses', 'Eligibility criteria included people aged ≥ 18 years, and exclude people who met the following criteria: severely crowded teeth; using interdental cleaning implement; having external injury in the oral cavity, or stomatitis; having less than 20 teeth; using orthodontic apparatus; visited to a dental clinic; having the possibility of consulting a dental clinic; having a dental license; not owning a smartphone or tablet device; smoker; taken antibiotics; pregnant; an allergy to the staining fluid; and employee of Sunstar Inc']","['intervention group who used the digital device, providing real-time visualized instructions by connection with a mobile application; and (2) a control group that used a digital device which only collected their brushing logs', 'digital device providing real-time visualized tooth brushing instructions']","['change in 6-point method plaque control record (PCR) score of all teeth', 'mean of PCR score', 'change of PCR score']","[{'cui': 'C4517542', 'cui_str': '118'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0040433', 'cui_str': 'Crowding of teeth'}, {'cui': 'C0442104', 'cui_str': 'Interdental'}, {'cui': 'C0542277', 'cui_str': 'Cleans drug injection equipment'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0443212', 'cui_str': 'External injury'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0038362', 'cui_str': 'Stomatitis'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0332276', 'cui_str': 'Orthodontic'}, {'cui': 'C0243111', 'cui_str': 'apparatus'}, {'cui': 'C0011344', 'cui_str': 'Dental clinic'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0011365', 'cui_str': 'Health Services, Dental'}, {'cui': 'C0023636', 'cui_str': 'Licenses'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0002111', 'cui_str': 'Allergy - specialty'}, {'cui': 'C0038128', 'cui_str': 'Stain'}, {'cui': 'C0005889', 'cui_str': 'Body fluid'}, {'cui': 'C0599987', 'cui_str': 'Employee'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0449379', 'cui_str': 'Connection'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0040461', 'cui_str': 'Brushing of teeth'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",118.0,0.27291,"The mean of PCR score at week 4 was 45.05% in the intervention group and 49.65% in the control group, and the change of PCR score from baseline was -20.46% in the intervention group and -15.77% in the control group (p = 0.088, 95% confidence interval -0.70-10.07). ","[{'ForeName': 'Haruka', 'Initials': 'H', 'LastName': 'Shida', 'Affiliation': 'Department of Preventive Services, Kyoto University School of Public Health, Kyoto, Japan.'}, {'ForeName': 'Satoe', 'Initials': 'S', 'LastName': 'Okabayashi', 'Affiliation': 'Kyoto University Health Service, Kyoto, Japan.'}, {'ForeName': 'Masami', 'Initials': 'M', 'LastName': 'Yoshioka', 'Affiliation': 'Department of Oral Health Sciences, Faculty of Health and Welfare, Tokushima Bunri University, Tokushima, Japan.'}, {'ForeName': 'Naoko', 'Initials': 'N', 'LastName': 'Takase', 'Affiliation': 'R&D Department, Sunstar Inc., Osaka, Japan.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Nishiura', 'Affiliation': 'R&D Department, Sunstar Inc., Osaka, Japan.'}, {'ForeName': 'Yui', 'Initials': 'Y', 'LastName': 'Okazawa', 'Affiliation': 'R&D Department, Sunstar Inc., Osaka, Japan.'}, {'ForeName': 'Kosuke', 'Initials': 'K', 'LastName': 'Kiyohara', 'Affiliation': ""Department of Food Science, Otsuma Women's University, Tokyo, Japan.""}, {'ForeName': 'Manako', 'Initials': 'M', 'LastName': 'Konda', 'Affiliation': 'Department of Preventive Services, Kyoto University School of Public Health, Kyoto, Japan.'}, {'ForeName': 'Norihiro', 'Initials': 'N', 'LastName': 'Nishioka', 'Affiliation': 'Department of Preventive Services, Kyoto University School of Public Health, Kyoto, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Kawamura', 'Affiliation': 'Kyoto University Health Service, Kyoto, Japan.'}, {'ForeName': 'Taku', 'Initials': 'T', 'LastName': 'Iwami', 'Affiliation': 'Kyoto University Health Service, Kyoto, Japan.'}]",PloS one,['10.1371/journal.pone.0235194'] 2138,32584909,Machine learning insight into the role of imaging and clinical variables for the prediction of obstructive coronary artery disease and revascularization: An exploratory analysis of the CONSERVE study.,"BACKGROUND Machine learning (ML) is able to extract patterns and develop algorithms to construct data-driven models. We use ML models to gain insight into the relative importance of variables to predict obstructive coronary artery disease (CAD) using the Coronary Computed Tomographic Angiography for Selective Cardiac Catheterization (CONSERVE) study, as well as to compare prediction of obstructive CAD to the CAD consortium clinical score (CAD2). We further perform ML analysis to gain insight into the role of imaging and clinical variables for revascularization. METHODS For prediction of obstructive CAD, the entire ICA arm of the study, comprising 719 patients was used. For revascularization, 1,028 patients were randomized to invasive coronary angiography (ICA) or coronary computed tomographic angiography (CCTA). Data was randomly split into 80% training 20% test sets for building and validation. Models used extreme gradient boosting (XGBoost). RESULTS Mean age was 60.6 ± 11.5 years and 64.3% were female. For the prediction of obstructive CAD, the AUC was significantly higher for ML at 0.779 (95% CI: 0.672-0.886) than for CAD2 (0.696 [95% CI: 0.594-0.798]) (P = 0.01). BMI, age, and angina severity were the most important variables. For revascularization, the model obtained an overall area under the receiver-operation curve (AUC) of 0.958 (95% CI = 0.933-0.983). Performance did not differ whether the imaging parameters used were from ICA (AUC 0.947, 95% CI = 0.903-0.990) or CCTA (AUC 0.941, 95% CI = 0.895-0.988) (P = 0.90). The ML model obtained sensitivity and specificity of 89.2% and 92.9%, respectively. Number of vessels with ≥70% stenosis, maximum segment stenosis severity (SSS) and body mass index (BMI) were the most important variables. Exclusion of imaging variables resulted in performance deterioration, with an AUC of 0.705 (95% CI 0.614-0.795) (P <0.0001). CONCLUSIONS For obstructive CAD, the ML model outperformed CAD2. BMI is an important variable, although currently not included in most scores. In this ML model, imaging variables were most associated with revascularization. Imaging modality did not influence model performance. Removal of imaging variables reduced model performance.",2020,"For the prediction of obstructive CAD, the AUC was significantly higher for ML at 0.779 (95% CI: 0.672-0.886) than for CAD2 (0.696 [95% CI: 0.594-0.798])","['1,028 patients were randomized to', 'Mean age was 60.6 ± 11.5 years and 64.3% were female', 'obstructive coronary artery disease and revascularization', '719 patients was used']","['Machine learning (ML', 'invasive coronary angiography (ICA) or coronary computed tomographic angiography (CCTA', 'Coronary Computed Tomographic Angiography']","['Performance', 'BMI', 'Number of vessels with ≥70% stenosis, maximum segment stenosis severity (SSS) and body mass index (BMI', 'BMI, age, and angina severity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517534', 'cui_str': '11.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}]","[{'cui': 'C0376284', 'cui_str': 'Machine Learning'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0085532', 'cui_str': 'Coronary angiography'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C1536105', 'cui_str': 'CT angiography'}]","[{'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0678234', 'cui_str': 'Form of stenosis'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0441635', 'cui_str': 'Segment'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0002962', 'cui_str': 'Angina pectoris'}]",1028.0,0.0893556,"For the prediction of obstructive CAD, the AUC was significantly higher for ML at 0.779 (95% CI: 0.672-0.886) than for CAD2 (0.696 [95% CI: 0.594-0.798])","[{'ForeName': 'Lohendran', 'Initials': 'L', 'LastName': 'Baskaran', 'Affiliation': 'Department of Radiology, New York-Presbyterian Hospital and Weill Cornell Medicine, New York, New York, United States of America.'}, {'ForeName': 'Xiaohan', 'Initials': 'X', 'LastName': 'Ying', 'Affiliation': 'Dalio Institute of Cardiovascular Imaging, Weill Cornell Medicine, New York, New York, United States of America.'}, {'ForeName': 'Zhuoran', 'Initials': 'Z', 'LastName': 'Xu', 'Affiliation': 'Department of Radiology, New York-Presbyterian Hospital and Weill Cornell Medicine, New York, New York, United States of America.'}, {'ForeName': 'Subhi J', 'Initials': 'SJ', 'LastName': ""Al'Aref"", 'Affiliation': 'Department of Radiology, New York-Presbyterian Hospital and Weill Cornell Medicine, New York, New York, United States of America.'}, {'ForeName': 'Benjamin C', 'Initials': 'BC', 'LastName': 'Lee', 'Affiliation': 'Department of Radiology, New York-Presbyterian Hospital and Weill Cornell Medicine, New York, New York, United States of America.'}, {'ForeName': 'Sang-Eun', 'Initials': 'SE', 'LastName': 'Lee', 'Affiliation': 'Division of Cardiology, Severance Cardiovascular Hospital, Integrative Cardiovascular Imaging Center, Yonsei University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Ibrahim', 'Initials': 'I', 'LastName': 'Danad', 'Affiliation': 'VU Medical Center, Amsterdam, the Netherlands.'}, {'ForeName': 'Hyung-Bok', 'Initials': 'HB', 'LastName': 'Park', 'Affiliation': 'Myongji Hospital, Seonam University College of Medicine, Gyeonggi-do, South Korea.'}, {'ForeName': 'Ravi', 'Initials': 'R', 'LastName': 'Bathina', 'Affiliation': 'CARE Hospital and FACTS Foundation, Hyderabad, India.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Baggiano', 'Affiliation': 'Centro Cardiologico Monzino, IRCCS, Milan, Italy.'}, {'ForeName': 'Virginia', 'Initials': 'V', 'LastName': 'Beltrama', 'Affiliation': 'Centro Cardiologico Monzino, IRCCS, Milan, Italy.'}, {'ForeName': 'Rodrigo', 'Initials': 'R', 'LastName': 'Cerci', 'Affiliation': 'Quanta Diagnostico Nuclear, Curitiba, Brazil.'}, {'ForeName': 'Eui-Young', 'Initials': 'EY', 'LastName': 'Choi', 'Affiliation': 'Gangnam Severance Hospital, Seoul, South Korea.'}, {'ForeName': 'Jung-Hyun', 'Initials': 'JH', 'LastName': 'Choi', 'Affiliation': 'Pusan National University Hospital, Busan, South Korea.'}, {'ForeName': 'So-Yeon', 'Initials': 'SY', 'LastName': 'Choi', 'Affiliation': 'Ajou University Hospital, Gyeonggi-do, South Korea.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Cole', 'Affiliation': 'Cardiology Associates of Mobile, Mobile, Alabama, United States of America.'}, {'ForeName': 'Joon-Hyung', 'Initials': 'JH', 'LastName': 'Doh', 'Affiliation': 'Inje University, Ilsan Paik Hospital, Gyeonggi-do, South Korea.'}, {'ForeName': 'Sang-Jin', 'Initials': 'SJ', 'LastName': 'Ha', 'Affiliation': 'Gangneung Asan Hospital, Gangwon-do, South Korea.'}, {'ForeName': 'Ae-Young', 'Initials': 'AY', 'LastName': 'Her', 'Affiliation': 'Kangwon National University Hospital, Gangwon-do, South Korea.'}, {'ForeName': 'Cezary', 'Initials': 'C', 'LastName': 'Kepka', 'Affiliation': 'Institute of Cardiology, Warsaw, Poland.'}, {'ForeName': 'Jang-Young', 'Initials': 'JY', 'LastName': 'Kim', 'Affiliation': 'Wonju Severance Hospital, Gangwon-do, South Korea.'}, {'ForeName': 'Jin-Won', 'Initials': 'JW', 'LastName': 'Kim', 'Affiliation': 'Korea University Guro Hospital, Seoul, South Korea.'}, {'ForeName': 'Sang-Wook', 'Initials': 'SW', 'LastName': 'Kim', 'Affiliation': 'Chung-Ang University Hospital, Seoul, South Korea.'}, {'ForeName': 'Woong', 'Initials': 'W', 'LastName': 'Kim', 'Affiliation': 'Yeungnam University Hospital, Daegu, South Korea.'}, {'ForeName': 'Yao', 'Initials': 'Y', 'LastName': 'Lu', 'Affiliation': 'Dalio Institute of Cardiovascular Imaging, Weill Cornell Medicine, New York, New York, United States of America.'}, {'ForeName': 'Amit', 'Initials': 'A', 'LastName': 'Kumar', 'Affiliation': 'Dalio Institute of Cardiovascular Imaging, Weill Cornell Medicine, New York, New York, United States of America.'}, {'ForeName': 'Ran', 'Initials': 'R', 'LastName': 'Heo', 'Affiliation': 'Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.'}, {'ForeName': 'Ji Hyun', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': 'Dalio Institute of Cardiovascular Imaging, Weill Cornell Medicine, New York, New York, United States of America.'}, {'ForeName': 'Ji-Min', 'Initials': 'JM', 'LastName': 'Sung', 'Affiliation': 'Severance Cardiovascular Hospital, Yonsei University Health System, Seoul, South Korea.'}, {'ForeName': 'Uma', 'Initials': 'U', 'LastName': 'Valeti', 'Affiliation': 'Department of Medicine, Stanford Medicine, Stanford, California, United States of America.'}, {'ForeName': 'Daniele', 'Initials': 'D', 'LastName': 'Andreini', 'Affiliation': 'Centro Cardiologico Monzino, IRCCS, Milan, Italy.'}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Pontone', 'Affiliation': 'Centro Cardiologico Monzino, IRCCS, Milan, Italy.'}, {'ForeName': 'Donghee', 'Initials': 'D', 'LastName': 'Han', 'Affiliation': 'Department of Imaging, Cedars-Sinai Medical Center, Cedars-Sinai Heart Institute, Los Angeles, California, United States of America.'}, {'ForeName': 'Todd C', 'Initials': 'TC', 'LastName': 'Villines', 'Affiliation': 'Department of Medicine, University of Virginia Health System, Charlottesville, Virginia, United States of America.'}, {'ForeName': 'Fay', 'Initials': 'F', 'LastName': 'Lin', 'Affiliation': 'Department of Radiology, New York-Presbyterian Hospital and Weill Cornell Medicine, New York, New York, United States of America.'}, {'ForeName': 'Hyuk-Jae', 'Initials': 'HJ', 'LastName': 'Chang', 'Affiliation': 'Division of Cardiology, Severance Cardiovascular Hospital, Integrative Cardiovascular Imaging Center, Yonsei University College of Medicine, Seoul, South Korea.'}, {'ForeName': 'James K', 'Initials': 'JK', 'LastName': 'Min', 'Affiliation': 'Department of Radiology, New York-Presbyterian Hospital and Weill Cornell Medicine, New York, New York, United States of America.'}, {'ForeName': 'Leslee J', 'Initials': 'LJ', 'LastName': 'Shaw', 'Affiliation': 'Department of Radiology, New York-Presbyterian Hospital and Weill Cornell Medicine, New York, New York, United States of America.'}]",PloS one,['10.1371/journal.pone.0233791'] 2139,32589342,Lottery incentives have short-term impact on ART initiation among men: results from a randomized pilot study.,"INTRODUCTION Among people living with HIV in South Africa, viral suppression is lower among men than women. The study aim was to test the impact of lottery incentives, which reward positive health choice (e.g. antiretroviral therapy (ART) linkage) with a chance to win a prize, on strengthening the HIV care continuum including ART initiation and viral suppression for men. METHODS We conducted a randomized, prospective trial of lottery incentives in the context of HIV testing and linkage to ART in rural KwaZulu-Natal, South Africa. Men living with HIV were randomly allocated to: lottery incentives and motivational text messages or motivational text messages only. Lottery prize eligibility was conditional on clinic registration, ART initiation, or viral suppression by one, three and six months respectively. After completing each continuum step, participants in the lottery group were notified whether they had won and were encouraged to continue in care. Lottery prizes were either a mobile phone, data or a gift card (valued at R1000/$100). Kaplan-Meier curves were plotted to determine time to ART initiation by study group. The primary outcome was viral suppression at six months. RESULTS Between November 2017 and December 2018, we tested 740 men for HIV and enrolled 131 HIV-positive men who reported not being on ART. At baseline, 100 (76%) participants were 30 years and older, 95 (73%) were unemployed and the median CD4 count was 472 cells/μL. At study exit, 84% (110/131) of participants had visited a clinic and 62% (81/131) were virally suppressed. Compared to motivational text messages, lottery incentives decreased the median time to ART initiation from 126 to 66 days (p = 0.0043, age-adjusted Cox regression) among all participants, and, from 134 days to 20 days (p = 0.0077) among participants who were not virally suppressed at baseline. Lottery incentives had an inconclusive effect on clinic registration (RR = 1.21, 95% CI: 0.83 to 1.76) and on viral suppression at six months (RR = 1.13, 95% CI: 0.73 to 1.75) compared to motivational text messages. CONCLUSIONS Conditional lottery incentives shortened the time to ART initiation among South African men. Behavioural economics strategies strengthen linkage to ART, but the study power was limited to see an impact on viral suppression. CLINICAL TRIAL NUMBER NCT03808194.",2020,"Compared to motivational text messages, lottery incentives decreased the median time to ART initiation from 126 to 66 days (p = 0.0043, age-adjusted Cox regression) among all participants, and, from 134 days to 20 days (p = 0.0077) among participants who were not virally suppressed at baseline.","['740 men for HIV and enrolled 131 HIV-positive men who reported not being on ART', 'people living with HIV in South Africa', 'South African men', 'Men living with HIV', 'Between November 2017 and December 2018', 'men', 'At baseline, 100 (76%) participants were 30\xa0years and older, 95 (73%) were unemployed and the median CD4 count was 472\xa0cells/μL', 'rural KwaZulu-Natal, South Africa']","['lottery incentives, which reward positive health choice (e.g. antiretroviral therapy (ART) linkage', 'lottery incentives and motivational text messages or motivational text messages only']","['median time to ART initiation', 'viral suppression', 'time to ART initiation', 'clinic registration']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0019699', 'cui_str': 'HIV positive'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0037712', 'cui_str': 'South Africa'}, {'cui': 'C0027567', 'cui_str': 'African race'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0041674', 'cui_str': 'Unemployed'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0243009', 'cui_str': 'CD4+ Cell Counts'}, {'cui': 'C0454729', 'cui_str': 'Natal'}]","[{'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C0035397', 'cui_str': 'Rewards'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}]",131.0,0.271571,"Compared to motivational text messages, lottery incentives decreased the median time to ART initiation from 126 to 66 days (p = 0.0043, age-adjusted Cox regression) among all participants, and, from 134 days to 20 days (p = 0.0077) among participants who were not virally suppressed at baseline.","[{'ForeName': 'Ruanne V', 'Initials': 'RV', 'LastName': 'Barnabas', 'Affiliation': 'Department of Global Health and Division of Allergy and Infectious Diseases, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Alastair', 'Initials': 'A', 'LastName': 'van Heerden', 'Affiliation': 'Human Sciences Research Council, Sweetwaters, KwaZulu-Natal, South Africa.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'McConnell', 'Affiliation': 'Harvard T. H. Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Adam A', 'Initials': 'AA', 'LastName': 'Szpiro', 'Affiliation': 'Department of Biostatistics, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Meighan L', 'Initials': 'ML', 'LastName': 'Krows', 'Affiliation': 'Department of Global Health and Division of Allergy and Infectious Diseases, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Torin T', 'Initials': 'TT', 'LastName': 'Schaafsma', 'Affiliation': 'Department of Global Health and Division of Allergy and Infectious Diseases, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Thulani', 'Initials': 'T', 'LastName': 'Ngubane', 'Affiliation': 'Human Sciences Research Council, Sweetwaters, KwaZulu-Natal, South Africa.'}, {'ForeName': 'Rose B', 'Initials': 'RB', 'LastName': 'Nxele', 'Affiliation': 'Human Sciences Research Council, Sweetwaters, KwaZulu-Natal, South Africa.'}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Joseph', 'Affiliation': 'Human Sciences Research Council, Sweetwaters, KwaZulu-Natal, South Africa.'}, {'ForeName': 'Jared M', 'Initials': 'JM', 'LastName': 'Baeten', 'Affiliation': 'Department of Global Health and Division of Allergy and Infectious Diseases, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Connie L', 'Initials': 'CL', 'LastName': 'Celum', 'Affiliation': 'Department of Global Health and Division of Allergy and Infectious Diseases, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'van Rooyen', 'Affiliation': 'Human Sciences Research Council, Sweetwaters, KwaZulu-Natal, South Africa.'}]",Journal of the International AIDS Society,['10.1002/jia2.25519'] 2140,32589354,Male partner testing and sexual behaviour following provision of multiple HIV self-tests to Kenyan women at higher risk of HIV infection in a cluster randomized trial.,"INTRODUCTION Without significant increases in uptake of HIV testing among men, it will be difficult to reduce HIV incidence to disease elimination levels. Secondary distribution of HIV self-tests by women to their male partners is a promising approach for increasing male testing that is being implemented in several countries. Here, we examine male partner and couples testing outcomes and sexual decision making associated with this approach in a cluster randomized trial. METHODS We examined data from women at higher risk of HIV participating in the intervention arm of an ongoing pair-matched cluster randomized trial in Kenya. HIV-negative women ≥18 years who self-reported ≥2 partners in the past month were eligible. Participants received self-tests at enrolment and three-monthly intervals. They were encouraged to offer tests to sexual partners with whom they anticipated condomless sex. At six months, we collected data on self-test distribution, male partner and couples testing, and testing and sexual behaviour in the three most recent transactional sex encounters. We used descriptive analyses and generalized estimating equation models to understand how sexual behaviour was influenced by self-test distribution. RESULTS From January 2018 to April 2019, 921/1057 (87%) participants completed six-month follow-up. Average age was 28 years, 65% were married, and 72% reported income through sex work. Participants received 7283 self-tests over six months, a median of eight per participant. Participants offered a median three self-tests to sexual partners. Of participants with a primary partner, 94% offered them a self-test. Of these, 97% accepted the test. When accepted, couples testing was reported among 91% of participants. Among 1954 transactional sex encounters, 64% included an offer to self-test. When offered self-tests were accepted by 93% of partners, and 84% who accepted conducted couples testing. Compared to partners with an HIV-negative result, condom use was higher when men had a reactive result (56.3% vs. 89.7%, p < 0.01), were not offered a self-test (56.3% vs. 62.0%, p = 0.02), or refused to self-test (56.3% vs. 78.3, p < 0.01). CONCLUSIONS Providing women with multiple self-tests facilitated male partner and couples testing, and led to safer sexual behaviour. These findings suggest secondary distribution is a promising approach for reaching men and has HIV prevention potential. Clinical Trial Number: NCT03135067.",2020,"p = 0.02), or refused to self-test (56.3% vs. 78.3, p < 0.01). ","['women at higher risk of HIV participating in the intervention arm of an ongoing pair-matched cluster randomized trial in Kenya', 'HIV-negative women ≥18\xa0years who self-reported ≥2 partners in the past month were eligible', 'Of participants with a primary partner, 94% offered them a self-test', 'From January 2018 to April 2019, 921/1057 (87%) participants completed six-month follow-up', 'sexual partners with whom they anticipated condomless sex', '1954 transactional sex encounters, 64% included an offer to self-test', 'women to their male partners', 'Average age was 28\xa0years, 65% were married, and 72% reported income through sex work']",[],"['HIV self-tests', 'uptake of HIV testing', 'self-test distribution, male partner and couples testing, and testing and sexual behaviour']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0022558', 'cui_str': 'Kenya'}, {'cui': 'C0481430', 'cui_str': 'HIV negative'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0036911', 'cui_str': 'Sexual partners'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0555047', 'cui_str': 'Married'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C0033595', 'cui_str': 'Works as prostitute'}]",[],"[{'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0459958', 'cui_str': 'HIV screening'}, {'cui': 'C0037775', 'cui_str': 'Distributions'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}]",,0.0719497,"p = 0.02), or refused to self-test (56.3% vs. 78.3, p < 0.01). ","[{'ForeName': 'Sue', 'Initials': 'S', 'LastName': 'Napierala', 'Affiliation': ""Women's Global Health Imperative, RTI International, San Francisco, CA, USA.""}, {'ForeName': 'Elizabeth F', 'Initials': 'EF', 'LastName': 'Bair', 'Affiliation': 'Department of Medical Ethics and Health Policy, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Noora', 'Initials': 'N', 'LastName': 'Marcus', 'Affiliation': 'Department of Medical Ethics and Health Policy, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}, {'ForeName': 'Perez', 'Initials': 'P', 'LastName': 'Ochwal', 'Affiliation': 'Impact Research and Development Organization, Kisumu, Kenya.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Maman', 'Affiliation': 'Department of Health Behavior, Gillings School of Global Public Health, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Kawango', 'Initials': 'K', 'LastName': 'Agot', 'Affiliation': 'Impact Research and Development Organization, Kisumu, Kenya.'}, {'ForeName': 'Harsha', 'Initials': 'H', 'LastName': 'Thirumurthy', 'Affiliation': 'Department of Medical Ethics and Health Policy, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.'}]",Journal of the International AIDS Society,['10.1002/jia2.25515'] 2141,32589630,Effect of tailoring anticoagulant treatment duration by applying a recurrence risk prediction model in patients with venous thromboembolism compared to usual care: A randomized controlled trial.,"BACKGROUND Patients with unprovoked (i.e., without the presence of apparent transient risk factors such as recent surgery) venous thromboembolism (VTE) are at risk of recurrence if anticoagulants are stopped after 3-6 months, yet their risk remains heterogeneous. Thus, prolonging anticoagulant treatment should be considered in high-risk patients, whereas stopping is likely preferred in those with a low predicted risk. The Vienna Prediction Model (VPM) could aid clinicians in estimating this risk, yet its clinical effects and external validity are currently unknown. The aim of this study was to investigate the clinical impact of this model on reducing recurrence risk in patients with unprovoked VTE, compared to usual care. METHODS AND FINDINGS In a randomized controlled trial, the decision to prolong or stop anticoagulant treatment was guided by predicted recurrence risk using the VPM (n = 441), which was compared with usual care (n = 442). Patients with unprovoked VTE were recruited from local thrombosis services in the Netherlands (in Utrecht, Harderwijk, Ede, Amersfoort, Zwolle, Hilversum, Rotterdam, Deventer, and Enschede) between 22 July 2011 and 30 November 2015, with 24-month follow-up complete for all patients by early 2018. The primary outcome was recurrent VTE during 24 months of follow-up. Secondary outcomes included major bleeding and clinically relevant non-major (CRNM) bleeding. In the total study population of 883 patients, mean age was 55 years, and 507 (57.4%) were men. A total of 96 recurrent VTE events (10.9%) were observed, 46 in the intervention arm and 50 in the control arm (risk ratio 0.92, 95% CI 0.63-1.35, p = 0.67). Major bleeding occurred in 4 patients, 2 in each treatment arm, whereas CRNM bleeding occurred in 20 patients (12 in intervention arm versus 8 in control arm). The VPM showed good discriminative power (c-statistic 0.76, 95% CI 0.69-0.83) and moderate to good calibration, notably at the lower spectrum of predicted risk. For instance, in 284 patients with a predicted risk of >2% to 4%, the observed rate of recurrence was 2.5% (95% CI 0.7% to 4.3%). The main limitation of this study is that it did not enroll the preplanned number of 750 patients in each study arm due to declining recruitment rate. CONCLUSIONS Our results show that application of the VPM in all patients with unprovoked VTE is unlikely to reduce overall recurrence risk. Yet, in those with a low predicted risk of recurrence, the observed rate was also low, suggesting that it might be safe to stop anticoagulant treatment in these patients. TRIAL REGISTRATION Netherlands Trial Register NTR2680.",2020,"The VPM showed good discriminative power (c-statistic 0.76, 95% CI 0.69-0.83) and moderate to good calibration, notably at the lower spectrum of predicted risk.","['284 patients', '883 patients, mean age was 55 years, and 507 (57.4%) were men', 'patients with venous thromboembolism compared to usual care', 'Patients with unprovoked VTE were recruited from local thrombosis services in the Netherlands (in Utrecht, Harderwijk, Ede, Amersfoort, Zwolle, Hilversum, Rotterdam, Deventer, and Enschede) between 22 July 2011 and 30 November 2015, with 24-month follow-up complete for all patients by early 2018', 'patients with unprovoked VTE, compared to usual care']",[],"['CRNM bleeding', 'recurrence risk', 'recurrent VTE', 'major bleeding and clinically relevant non-major (CRNM) bleeding', 'overall recurrence risk', 'Major bleeding', 'rate of recurrence']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0450381', 'cui_str': '507'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C1861172', 'cui_str': 'Thromboembolism, Venous'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0040053', 'cui_str': 'Thrombosis'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0027778', 'cui_str': 'Netherlands'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C1279919', 'cui_str': 'Early'}]",[],"[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C1861172', 'cui_str': 'Thromboembolism, Venous'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",284.0,0.138641,"The VPM showed good discriminative power (c-statistic 0.76, 95% CI 0.69-0.83) and moderate to good calibration, notably at the lower spectrum of predicted risk.","[{'ForeName': 'Geert-Jan', 'Initials': 'GJ', 'LastName': 'Geersing', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands.'}, {'ForeName': 'Janneke M T', 'Initials': 'JMT', 'LastName': 'Hendriksen', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands.'}, {'ForeName': 'Nicolaas P A', 'Initials': 'NPA', 'LastName': 'Zuithoff', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands.'}, {'ForeName': 'Kit C', 'Initials': 'KC', 'LastName': 'Roes', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands.'}, {'ForeName': 'Ruud', 'Initials': 'R', 'LastName': 'Oudega', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands.'}, {'ForeName': 'Toshihiko', 'Initials': 'T', 'LastName': 'Takada', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands.'}, {'ForeName': 'Roger E G', 'Initials': 'REG', 'LastName': 'Schutgens', 'Affiliation': 'Van Creveld Clinic, University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands.'}, {'ForeName': 'Karel G M', 'Initials': 'KGM', 'LastName': 'Moons', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, the Netherlands.'}]",PLoS medicine,['10.1371/journal.pmed.1003142'] 2142,32589648,"Safety and efficacy of N-acetylcysteine in hospitalized patients with HIV-associated tuberculosis: An open-label, randomized, phase II trial (RIPENACTB Study).","Despite the availability of effective antimicrobials, tuberculosis (TB) is still a serious health threat. Mortality is even higher in people living with HIV who are diagnosed with TB. New therapies are needed to shorten the time required to cure TB and decrease fatality rates in this population. N-acetylcysteine (NAC) is a glutathione precursor and has shown recently in experimental setting to present in vitro and in vivo anti-mycobacterial activity. We test the hypothesis that NAC is safe, well tolerated and secondarily efficacious as adjunctive anti-TB therapy in hospitalized individuals with HIV-associated TB. Patients were enrolled sequentially in a tertiary care center, in the Brazilian Amazon. We performed a randomized, parallel group, single-center, open study trial of two arms, in hospitalized patients over 18 years of age, with microbiologically confirmed pulmonary TB in HIV: one with rifampicin, isoniazid, pyrazinamide and ethambutol at standard doses (Control Group), and a second in which NAC 600 mg bid for eight weeks was added (NAC Group). A total of 21 and 18 patients were enrolled to the Control Group and NAC Group, respectively. Adverse event rates were similar in the two arms. Our findings suggest that in the more critical population of hospitalized patients with HIV-associated TB, the use of NAC was not unsafe, despite the low sample size, and a potential impact on faster negative cultures needs to be further explored in larger studies.",2020,Adverse event rates were similar in the two arms.,"['hospitalized individuals with HIV-associated TB', 'hospitalized patients over 18 years of age, with microbiologically confirmed pulmonary TB in HIV: one with', 'Patients were enrolled sequentially in a tertiary care center, in the Brazilian Amazon', 'A total of 21 and 18 patients were enrolled to the Control Group and NAC Group, respectively', 'people living with HIV who are diagnosed with TB', 'hospitalized patients with HIV-associated tuberculosis']","['NAC', 'N-acetylcysteine (NAC', 'N-acetylcysteine', 'rifampicin, isoniazid, pyrazinamide and ethambutol at standard doses (Control Group), and a second in which NAC 600 mg bid for eight weeks was added (NAC']","['Adverse event rates', 'Safety and efficacy', 'Mortality']","[{'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0041296', 'cui_str': 'Tuberculosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0041327', 'cui_str': 'Pulmonary tuberculosis'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0325969', 'cui_str': 'Genus Amazona'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001047', 'cui_str': 'Acetylcysteine'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0001047', 'cui_str': 'Acetylcysteine'}, {'cui': 'C0035608', 'cui_str': 'Rifampin'}, {'cui': 'C0022209', 'cui_str': 'isoniazid'}, {'cui': 'C0034239', 'cui_str': 'Pyrazinamide'}, {'cui': 'C0014964', 'cui_str': 'Ethambutol'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0048106', 'cui_str': ""4-benzamido-4'-isothiocyanostilbene-2,2'-disulfonate""}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",21.0,0.095281,Adverse event rates were similar in the two arms.,"[{'ForeName': 'Izabella Picinin', 'Initials': 'IP', 'LastName': 'Safe', 'Affiliation': 'Fundação de Medicina Tropical Dr. Heitor Vieira Dourado, Manaus, Brazil.'}, {'ForeName': 'Marcus Vinícius Guimarães', 'Initials': 'MVG', 'LastName': 'Lacerda', 'Affiliation': 'Fundação de Medicina Tropical Dr. Heitor Vieira Dourado, Manaus, Brazil.'}, {'ForeName': 'Vitoria Silva', 'Initials': 'VS', 'LastName': 'Printes', 'Affiliation': 'Fundação de Medicina Tropical Dr. Heitor Vieira Dourado, Manaus, Brazil.'}, {'ForeName': 'Adriana Ferreira', 'Initials': 'AF', 'LastName': 'Praia Marins', 'Affiliation': 'Fundação de Medicina Tropical Dr. Heitor Vieira Dourado, Manaus, Brazil.'}, {'ForeName': 'Amanda Lia', 'Initials': 'AL', 'LastName': 'Rebelo Rabelo', 'Affiliation': 'Programa de Pós-Graduação em Medicina Tropical, Universidade do Estado do Amazonas, Manaus, Brazil.'}, {'ForeName': 'Amanda Araújo', 'Initials': 'AA', 'LastName': 'Costa', 'Affiliation': 'Fundação de Medicina Tropical Dr. Heitor Vieira Dourado, Manaus, Brazil.'}, {'ForeName': 'Michel Araújo', 'Initials': 'MA', 'LastName': 'Tavares', 'Affiliation': 'Universidade Federal do Amazonas, Manaus, Brazil.'}, {'ForeName': 'Jaquelane Silva', 'Initials': 'JS', 'LastName': 'Jesus', 'Affiliation': 'Fundação de Medicina Tropical Dr. Heitor Vieira Dourado, Manaus, Brazil.'}, {'ForeName': 'Alexandra Brito', 'Initials': 'AB', 'LastName': 'Souza', 'Affiliation': 'Programa de Pós-Graduação em Medicina Tropical, Universidade do Estado do Amazonas, Manaus, Brazil.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Beraldi-Magalhães', 'Affiliation': 'Programa de Pós-Graduação em Medicina Tropical, Universidade do Estado do Amazonas, Manaus, Brazil.'}, {'ForeName': 'Cynthia Pessoa', 'Initials': 'CP', 'LastName': 'Neves', 'Affiliation': 'Fundação de Medicina Tropical Dr. Heitor Vieira Dourado, Manaus, Brazil.'}, {'ForeName': 'Wuelton Marcelo', 'Initials': 'WM', 'LastName': 'Monteiro', 'Affiliation': 'Fundação de Medicina Tropical Dr. Heitor Vieira Dourado, Manaus, Brazil.'}, {'ForeName': 'Vanderson Souza', 'Initials': 'VS', 'LastName': 'Sampaio', 'Affiliation': 'Fundação de Medicina Tropical Dr. Heitor Vieira Dourado, Manaus, Brazil.'}, {'ForeName': 'Eduardo P', 'Initials': 'EP', 'LastName': 'Amaral', 'Affiliation': 'Immunobiology Section, National Institutes of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, Maryland, United States of America.'}, {'ForeName': 'Renata Spener', 'Initials': 'RS', 'LastName': 'Gomes', 'Affiliation': 'Programa de Pós-Graduação em Medicina Tropical, Universidade do Estado do Amazonas, Manaus, Brazil.'}, {'ForeName': 'Bruno B', 'Initials': 'BB', 'LastName': 'Andrade', 'Affiliation': 'Laboratório de Inflamação e Biomarcadores, Instituto Gonçalo Moniz, Fundação Oswaldo Cruz (FIOCRUZ), Salvador, Brazil.'}, {'ForeName': 'Marcelo', 'Initials': 'M', 'LastName': 'Cordeiro-Santos', 'Affiliation': 'Fundação de Medicina Tropical Dr. Heitor Vieira Dourado, Manaus, Brazil.'}]",PloS one,['10.1371/journal.pone.0235381'] 2143,32589670,"Does the type of foam roller influence the recovery rate, thermal response and DOMS prevention?","PURPOSE Supporting post-exercise recovery requires choosing not only the right treatment but also the equipment, in which the impact is not always clear. The study aimed to determine the effect of foam rolling on the rate of lactate removal and DOMS prevention and whether the type of foam roller is effective in the context of post-exercise recovery. METHODS This randomized trial enrolled 33 active healthy males divided into three groups of eleven individuals: foam rolling with a smooth (STH) or grid roller (GRID) or passive recovery (PAS). All the participants performed full squat jumps for one minute. Examination took place at rest (thermal imaging of skin temperature-[Tsk] and blood lactate-[LA]), immediately following exercise (Tsk & LA), immediately after recovery treatment (Tsk) and after 30 minutes of rest (Tsk & LA). Their pain levels were assessed using the Visual Analog Scale (VAS) 24, 48, 72, and 96 hours after exercise. RESULTS The magnitude of lactate decrease depended on the type of recovery used. In the PAS group, the decrease in lactate concentration by 2.65 mmol/L following a half-hour rest was significantly lower than that in the other groups (STH vs. PAS p = 0.042 / GRID vs. PAS p = 0.025). For thermal responses, significant differences between both experimental groups were noted only 30 minutes after exercise. A significant decrease in pain in the STH group occurred between 48 and 96 hours, while the GRID group showed a systematic significant decrease in VAS values in subsequent measurements. Changes in VAS values in subsequent measurements in the PAS group were not statistically significant (p>0.05). CONCLUSIONS Foam rolling seems to be effective for enhancing lactate clearance and counteracting DOMS, but the type of foam roller does not seem to influence the recovery rate.",2020,"Changes in VAS values in subsequent measurements in the PAS group were not statistically significant (p>0.05). ",['33 active healthy males divided into three groups of eleven individuals'],['foam rolling with a smooth (STH) or grid roller (GRID) or passive recovery (PAS'],"['VAS values', 'lactate concentration', 'pain levels', 'recovery rate, thermal response and DOMS prevention', 'pain']","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0991510', 'cui_str': 'Foam'}, {'cui': 'C0205357', 'cui_str': 'Smooth'}, {'cui': 'C0326180', 'cui_str': 'Coraciidae'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0518087', 'cui_str': 'Pain level'}, {'cui': 'C0013007', 'cui_str': 'Methyldimethoxyamphetamine'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",33.0,0.0430707,"Changes in VAS values in subsequent measurements in the PAS group were not statistically significant (p>0.05). ","[{'ForeName': 'Jakub Grzegorz', 'Initials': 'JG', 'LastName': 'Adamczyk', 'Affiliation': 'Theory of Sport Department, Józef Piłsudski University of Physical Education in Warsaw, Warsaw, Poland.'}, {'ForeName': 'Karol', 'Initials': 'K', 'LastName': 'Gryko', 'Affiliation': 'Athletics and Team Sport Games Department, Józef Piłsudski University of Physical Education in Warsaw, Warsaw, Poland.'}, {'ForeName': 'Dariusz', 'Initials': 'D', 'LastName': 'Boguszewski', 'Affiliation': 'Rehabilitation Department, Physiotherapy Division, Medical University of Warsaw, Warsaw, Poland.'}]",PloS one,['10.1371/journal.pone.0235195'] 2144,32589686,Optimal priming of poxvirus vector (NYVAC)-based HIV vaccine regimens for T cell responses requires three DNA injections. Results of the randomized multicentre EV03/ANRS VAC20 Phase I/II Trial.,"DNA vectors have been widely used as a priming of poxvirus vaccine in prime/boost regimens. Whether the number of DNA impacts qualitatively or quantitatively the immune response is not fully explored. With the aim to reinforce T-cell responses by optimizing the prime-boost regimen, the multicentric EV03/ANRS VAC20 phase I/II trial, randomized 147 HIV-negative volunteers to either 3xDNA plus 1xNYVAC (weeks 0, 4, 8 plus 24; n = 74) or to 2xDNA plus 2xNYVAC (weeks 0, 4 plus 20, 24; n = 73) groups. T-cell responses (IFN-γ ELISPOT) to at least one peptide pool were higher in the 3xDNA than the 2xDNA groups (91% and 80% of vaccinees) (P = 0.049). In the 3xDNA arm, 26 (37%) recipients developed a broader T-cell response (Env plus at least to one of the Gag, Pol, Nef pools) than in the 2xDNA (15; 22%) arms (primary endpoint; P = 0.047) with a higher magnitude against Env (at week 26) (P<0.001). In both groups, vaccine regimens induced HIV-specific polyfunctional CD4 and CD8 T cells and the production of Th1, Th2 and Th17/IL-21 cytokines. Antibody responses were also elicited in up to 81% of vaccines. A higher percentage of IgG responders was noted in the 2xDNA arm compared to the 3xDNA arm, while the 3xDNA group tended to elicit a higher magnitude of IgG3 response against specific Env antigens. We show here that the modulation of the prime strategy, without modifying the route or the dose of administration, or the combination of vectors, may influence the quality of the responses.",2020,T-cell responses (IFN-γ ELISPOT) to at least one peptide pool were higher in the 3xDNA than the 2xDNA groups (91% and 80% of vaccinees) (P = 0.049).,['147 HIV-negative volunteers to either'],"['poxvirus vector (NYVAC)-based HIV vaccine regimens', '3xDNA plus 1xNYVAC', '2xDNA plus 2xNYVAC']","['Antibody responses', 'IgG responders', 'HIV-specific polyfunctional CD4 and CD8 T cells and the production of Th1, Th2 and Th17/IL-21 cytokines', 'broader T-cell response', 'T-cell responses (IFN-γ ELISPOT', 'IgG3 response']","[{'cui': 'C0481430', 'cui_str': 'HIV negative'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]","[{'cui': 'C0032868', 'cui_str': 'Poxviridae'}, {'cui': 'C0012656', 'cui_str': 'Infectious Disease Vectors'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0003261', 'cui_str': 'Antibody Production'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0003323', 'cui_str': 'Lymphocyte antigen CD4'}, {'cui': 'C0085358', 'cui_str': 'Lymphocyte antigen CD8'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0332464', 'cui_str': 'Widening'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}, {'cui': 'C0920508', 'cui_str': 'Enzyme linked immunospot assay'}, {'cui': 'C0020859', 'cui_str': 'Immunoglobulin IgG3'}]",147.0,0.0624733,T-cell responses (IFN-γ ELISPOT) to at least one peptide pool were higher in the 3xDNA than the 2xDNA groups (91% and 80% of vaccinees) (P = 0.049).,"[{'ForeName': 'Yves', 'Initials': 'Y', 'LastName': 'Lévy', 'Affiliation': 'Vaccine Research Institute, Université Paris-Est Créteil, Faculté de Médecine, INSERM U955, équipe 16, Créteil, France.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Lacabaratz', 'Affiliation': 'Vaccine Research Institute, Université Paris-Est Créteil, Faculté de Médecine, INSERM U955, équipe 16, Créteil, France.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Ellefsen-Lavoie', 'Affiliation': 'Centre Hospitalier Universitaire Vaudois (CHUV), Lausanne, Switzerland.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Stöhr', 'Affiliation': 'MRC Clinical Trials Unit at UCL, London, United Kingdom.'}, {'ForeName': 'Jean-Daniel', 'Initials': 'JD', 'LastName': 'Lelièvre', 'Affiliation': 'Vaccine Research Institute, Université Paris-Est Créteil, Faculté de Médecine, INSERM U955, équipe 16, Créteil, France.'}, {'ForeName': 'Pierre-Alexandre', 'Initials': 'PA', 'LastName': 'Bart', 'Affiliation': 'Centre Hospitalier Universitaire Vaudois (CHUV), Lausanne, Switzerland.'}, {'ForeName': 'Odile', 'Initials': 'O', 'LastName': 'Launay', 'Affiliation': 'Université de Paris, Faculté de médecine Paris Descartes; Inserm, CIC 1417, F-CRIN I-REIVAC; Assistance Publique-Hôpitaux de Paris, CIC Cochin Pasteur, Paris, France.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Weber', 'Affiliation': 'Imperial College London, London, United Kingdom.'}, {'ForeName': 'Bernd', 'Initials': 'B', 'LastName': 'Salzberger', 'Affiliation': 'University Hospital, Institute of Clinical Microbiology and Hygiene, University of Regensburg, Regensburg, Germany.'}, {'ForeName': 'Aurélie', 'Initials': 'A', 'LastName': 'Wiedemann', 'Affiliation': 'Vaccine Research Institute, Université Paris-Est Créteil, Faculté de Médecine, INSERM U955, équipe 16, Créteil, France.'}, {'ForeName': 'Mathieu', 'Initials': 'M', 'LastName': 'Surenaud', 'Affiliation': 'Vaccine Research Institute, Université Paris-Est Créteil, Faculté de Médecine, INSERM U955, équipe 16, Créteil, France.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Koelle', 'Affiliation': 'Department of Medicine & Department of Global Health, University of Washington, Fred Hutchinson Cancer Research Center Seattle, Washington, United States of America.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Wolf', 'Affiliation': 'University Hospital, Institute of Clinical Microbiology and Hygiene, University of Regensburg, Regensburg, Germany.'}, {'ForeName': 'Ralf', 'Initials': 'R', 'LastName': 'Wagner', 'Affiliation': 'University Hospital, Institute of Clinical Microbiology and Hygiene, University of Regensburg, Regensburg, Germany.'}, {'ForeName': 'Véronique', 'Initials': 'V', 'LastName': 'Rieux', 'Affiliation': 'Vaccine Research Institute, Université Paris-Est Créteil, Faculté de Médecine, INSERM U955, équipe 16, Créteil, France.'}, {'ForeName': 'David C', 'Initials': 'DC', 'LastName': 'Montefiori', 'Affiliation': 'Department of Surgery, Duke Human Vaccine Institute, Duke University Medical Center, Durham, North Carolina, United States of America.'}, {'ForeName': 'Nicole L', 'Initials': 'NL', 'LastName': 'Yates', 'Affiliation': 'Department of Surgery, Duke Human Vaccine Institute, Duke University Medical Center, Durham, North Carolina, United States of America.'}, {'ForeName': 'Georgia D', 'Initials': 'GD', 'LastName': 'Tomaras', 'Affiliation': 'Department of Surgery, Duke Human Vaccine Institute, Duke University Medical Center, Durham, North Carolina, United States of America.'}, {'ForeName': 'Raphael', 'Initials': 'R', 'LastName': 'Gottardo', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, United States of America.'}, {'ForeName': 'Bryan', 'Initials': 'B', 'LastName': 'Mayer', 'Affiliation': 'Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, Seattle, Washington, United States of America.'}, {'ForeName': 'Song', 'Initials': 'S', 'LastName': 'Ding', 'Affiliation': 'EuroVacc Foundation, Lausanne, Switzerland.'}, {'ForeName': 'Rodolphe', 'Initials': 'R', 'LastName': 'Thiébaut', 'Affiliation': 'Inserm, Bordeaux Population Health Research Center, UMR 1219, University Bordeaux, ISPED, CIC 1401-EC, Univ Bordeaux, Bordeaux, France.'}, {'ForeName': 'Sheena', 'Initials': 'S', 'LastName': 'McCormack', 'Affiliation': 'MRC Clinical Trials Unit at UCL, London, United Kingdom.'}, {'ForeName': 'Geneviève', 'Initials': 'G', 'LastName': 'Chêne', 'Affiliation': 'Inserm, Bordeaux Population Health Research Center, UMR 1219, University Bordeaux, ISPED, CIC 1401-EC, Univ Bordeaux, Bordeaux, France.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Pantaleo', 'Affiliation': 'Centre Hospitalier Universitaire Vaudois (CHUV), Lausanne, Switzerland.'}]",PLoS pathogens,['10.1371/journal.ppat.1008522'] 2145,32594832,Effects of a home-based occupational therapy telerehabilitation via smartphone for outpatients after hip fracture surgery: A feasibility randomised controlled study.,"INTRODUCTION This study aimed to investigate the effects of a home-based occupational therapy telerehabilitation (TR) via smartphone in enhancing functional and motor performance and fall efficacy for outpatients receiving day hospital rehabilitation after hip fracture surgery in Hong Kong. METHODS This was a feasibility randomised controlled trial with two groups - an experimental group and a comparison group - and a sample of 31 older adults attending a geriatric day hospital who had undergone hip fracture surgery within 12 weeks of diagnosis. Patients were assessed at baseline, immediately after a three-week intervention and at three-week post-intervention follow-up for motor performance, activities of daily living (ADL) functioning and fall efficacy. The experimental group received a home programme using the Caspar Health e-system and a mobile app for smartphones, while the comparison group received paper-and-pencil instructions for the home programme on a weekly basis for three weeks. RESULTS Compared to the comparison group, significant improvements in fall efficacy and instrumental ADL performance at post intervention and follow-up were found in the experimental group. However, in the comparison group, inadequate social support was a factor contributing to better muscle strength testing in both the affected and non-affected legs. There were no significant differences between the two groups in regard to the other variables. DISCUSSION This study supports the potential use of TR via smartphone as an alternative home programme for use in occupational therapy practice with older adults after hip fracture surgery.",2020,"Compared to the comparison group, significant improvements in fall efficacy and instrumental ADL performance at post intervention and follow-up were found in the experimental group.","['older adults after hip fracture surgery', 'outpatients after hip fracture surgery', 'outpatients receiving day hospital rehabilitation after hip fracture surgery in Hong Kong', '31 older adults attending a geriatric day hospital who had undergone hip fracture surgery within 12 weeks of diagnosis']","['home-based occupational therapy telerehabilitation (TR) via smartphone', 'home programme using the Caspar Health e-system and a mobile app for smartphones, while the comparison group received paper-and-pencil instructions', 'TR via smartphone', 'home-based occupational therapy telerehabilitation via smartphone']","['fall efficacy and instrumental ADL performance', 'functional and motor performance and fall efficacy', 'motor performance, activities of daily living (ADL) functioning and fall efficacy']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0019557', 'cui_str': 'Hip fracture'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0587438', 'cui_str': 'Day hospital'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0019907', 'cui_str': 'Hong Kong'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0017469', 'cui_str': 'Geriatric medicine'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1318464', 'cui_str': 'Occupational therapy'}, {'cui': 'C4042802', 'cui_str': 'Remote Rehabilitation'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0030351', 'cui_str': 'Paper'}, {'cui': 'C0441059', 'cui_str': 'Pencil'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}]","[{'cui': 'C0000921', 'cui_str': 'Accidental fall'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0150641', 'cui_str': 'Instrumental activities of daily living'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}]",31.0,0.0284202,"Compared to the comparison group, significant improvements in fall efficacy and instrumental ADL performance at post intervention and follow-up were found in the experimental group.","[{'ForeName': 'Cabbee Tl', 'Initials': 'CT', 'LastName': 'Li', 'Affiliation': 'Department of Rehabilitation Sciences, The Hong Kong Polytechnic University, Hong Kong.'}, {'ForeName': 'Goris Kn', 'Initials': 'GK', 'LastName': 'Hung', 'Affiliation': 'Department of Rehabilitation Sciences, The Hong Kong Polytechnic University, Hong Kong.'}, {'ForeName': 'Kenneth Nk', 'Initials': 'KN', 'LastName': 'Fong', 'Affiliation': 'Department of Rehabilitation Sciences, The Hong Kong Polytechnic University, Hong Kong.'}, {'ForeName': 'Pablo Cruz', 'Initials': 'PC', 'LastName': 'Gonzalez', 'Affiliation': 'Department of Rehabilitation Sciences, The Hong Kong Polytechnic University, Hong Kong.'}, {'ForeName': 'Shu-Hong', 'Initials': 'SH', 'LastName': 'Wah', 'Affiliation': 'Geriatric Day Hospital, Haven of Hope Hospital, Hong Kong.'}, {'ForeName': 'Hector Wh', 'Initials': 'HW', 'LastName': 'Tsang', 'Affiliation': 'Department of Rehabilitation Sciences, The Hong Kong Polytechnic University, Hong Kong.'}]",Journal of telemedicine and telecare,['10.1177/1357633X20932434'] 2146,32594854,"The impact of beetroot juice supplementation on muscular endurance, maximal strength and countermovement jump performance.","Purpose: Dietary nitrate has been shown to enhance muscle contractile function and has, therefore, been linked to increased muscle power and sprint exercise performance. However, the impact of dietary nitrate supplementation on maximal strength, performance and muscular endurance remains to be established. Methods: Fifteen recreationally active males (25±4 y, BMI 24±3 kg/m 2 ) participated in a randomized double-blinded cross-over study comprising two 6-d supplementation periods; 140 mL/d nitrate-rich (BR; 985 mg/d) and nitrate-depleted (PLA; 0.37 mg/d) beetroot juice. Three hours following the last supplement, we assessed countermovement jump (CMJ) performance, maximal strength and power of the upper leg by voluntary isometric (30° and 60° angle) and isokinetic contractions (60, 120, 180 and 300°·s -1 ), and muscular endurance (total workload) by 30 reciprocal isokinetic voluntary contractions at 180°·s -1 . Results: Despite differences in plasma nitrate (BR: 879±239 vs PLA: 33±13 μmol/L, P <0.001) and nitrite (BR: 463±217 vs PLA: 176±50 nmol/L, P <0.001) concentrations prior to exercise testing, CMJ height (BR: 39.3±6.3 vs PLA: 39.6±6.3 cm; P =0.39) and muscular endurance (BR: 3.93±0.69 vs PLA: 3.90±0.66 kJ; P =0.74) were not different between treatments. In line, isometric strength ( P >0.50 for both angles) and isokinetic knee extension power ( P >0.33 for all velocities) did not differ between treatments. Isokinetic knee flexion power was significantly higher following BR compared with PLA ingestion at 60°·s -1 ( P =0.001), but not at 120°·s -1 ( P =0.24), 180°·s -1 ( P =0.066), and 300°·s -1 ( P =0.36). Conclusion: Nitrate supplementation does not improve maximal strength, countermovement jump performance and muscular endurance in healthy, active males.",2020,"Isokinetic knee flexion power was significantly higher following BR compared with PLA ingestion at 60°·s -1 ( P =0.001), but not at 120°·s -1 ( P =0.24), 180°·s -1 ( P =0.066), and 300°·s -1 ( P =0.36). ","['healthy, active males', 'Fifteen recreationally active males (25±4 y']","['beetroot juice supplementation', 'dietary nitrate supplementation', 'PLA', 'Nitrate supplementation', 'nitrate-depleted (PLA; 0.37 mg/d) beetroot juice']","['muscular endurance (total workload) by 30 reciprocal isokinetic voluntary contractions', 'muscular endurance', 'CMJ height (BR', 'maximal strength, performance and muscular endurance', 'muscular endurance, maximal strength and countermovement jump performance', 'isokinetic knee extension power', 'Isokinetic knee flexion power', 'maximal strength, countermovement jump performance and muscular endurance', 'countermovement jump (CMJ) performance, maximal strength and power of the upper leg by voluntary isometric (30° and 60° angle) and isokinetic contractions', 'isometric strength', 'plasma nitrate']","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C1095905', 'cui_str': 'Beets preparation'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0028125', 'cui_str': 'Nitrate salt'}, {'cui': 'C0456170', 'cui_str': 'Left atrial pressure'}, {'cui': 'C4517454', 'cui_str': '0.37'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}]","[{'cui': 'C0442025', 'cui_str': 'Muscular'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0085122', 'cui_str': 'Work Load'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0028125', 'cui_str': 'Nitrate salt'}]",2.0,0.0542704,"Isokinetic knee flexion power was significantly higher following BR compared with PLA ingestion at 60°·s -1 ( P =0.001), but not at 120°·s -1 ( P =0.24), 180°·s -1 ( P =0.066), and 300°·s -1 ( P =0.36). ","[{'ForeName': 'Kristin L', 'Initials': 'KL', 'LastName': 'Jonvik', 'Affiliation': 'Sport and Exercise Nutrition, Institute of Sports and Exercise Studies, HAN University of Applied Sciences, Nijmegen, the Netherlands.'}, {'ForeName': 'Daan', 'Initials': 'D', 'LastName': 'Hoogervorst', 'Affiliation': 'Sport and Exercise Nutrition, Institute of Sports and Exercise Studies, HAN University of Applied Sciences, Nijmegen, the Netherlands.'}, {'ForeName': 'Harmen B', 'Initials': 'HB', 'LastName': 'Peelen', 'Affiliation': 'Department of Movement and Sports Science, Ghent University, Belgium.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'de Niet', 'Affiliation': 'Sport and Exercise Nutrition, Institute of Sports and Exercise Studies, HAN University of Applied Sciences, Nijmegen, the Netherlands.'}, {'ForeName': 'Lex B', 'Initials': 'LB', 'LastName': 'Verdijk', 'Affiliation': 'Department of Human Biology, NUTRIM School of Nutrition and Translational Research in Metabolism, Maastricht University Medical Centre+, the Netherlands.'}, {'ForeName': 'Luc J C', 'Initials': 'LJC', 'LastName': 'van Loon', 'Affiliation': 'Sport and Exercise Nutrition, Institute of Sports and Exercise Studies, HAN University of Applied Sciences, Nijmegen, the Netherlands.'}, {'ForeName': 'Jan-Willem', 'Initials': 'JW', 'LastName': 'van Dijk', 'Affiliation': 'Sport and Exercise Nutrition, Institute of Sports and Exercise Studies, HAN University of Applied Sciences, Nijmegen, the Netherlands.'}]",European journal of sport science,['10.1080/17461391.2020.1788649'] 2147,32594858,"Time-Course of Changes in Performance, Biomechanical, Physiological and Perceptual Responses Following Resistance Training Sessions.","This study determined the time-course of recovery after resistance training (RT) sessions and the association between changes in performance with changes in biomechanical, physiological and perceptual parameters. After a 4-week familiarization period, 14 resistance-trained males performed 3 experimental conditions, each one including 2 sessions with a recovery interval of 24h, 48h or 72h, in a randomized order. RT sessions consisted of 5 sets of 8-10RM on squat and leg press exercises. The resistance was equal for the 2 sessions of each condition and repetitions were performed until concentric failure. Volume load (VL) and first set volume load (FSVL) were compared between sessions. Tests before each session included countermovement jump (CMJ), maximal voluntary isometric contraction (MVIC), creatine kinase (CK) and delayed onset muscle soreness (DOMS). (2x3) ANOVA with effect sizes (ES) assessed the time-course of recovery and Kendall test the correlation between variables (α=0.05). Significant interaction was observed for all variables, except for CK, where a condition main effect occurred. Comparisons between post and pre-intervals showed VL (p=0.011;ES=-0.90) decreased for 24h condition, while FSVL remained decreased for 48h (p=0.031;ES=-0.63) and DOMS increased (p=0.001;ES=3.52). CMJ (p=0.025;ES=0.25) and MVIC (p=0.031;ES=0.14) performance increased at 72h. FSVL (r=0.424), CMJ (r=0.439), MVIC (r=0.389) and DOMS (r=-0.327) were significantly correlated with VL (p<0.05). Time-course of VL showed the necessity of at least 48h for the reestablishment of performance, though better perceptual responses were evident at 72h. Thus, both recovery intervals may be beneficial after lower-limbs RT until concentric failure, though chronic effects still need to be investigated.",2020,CMJ (p=0.025;ES=0.25) and MVIC,[],"['FSVL', 'resistance training (RT) sessions', 'MVIC', 'CMJ']","['Time-Course of Changes in Performance, Biomechanical, Physiological and Perceptual Responses', 'Volume load (VL) and first set volume load (FSVL', 'MVIC (r=0.389) and DOMS', 'DOMS', 'VL (p=0.011;ES=-0.90) decreased for 24h condition, while FSVL', 'countermovement jump (CMJ), maximal voluntary isometric contraction (MVIC), creatine kinase (CK) and delayed onset muscle soreness (DOMS', 'time-course of recovery and Kendall test']",[],"[{'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0022205', 'cui_str': 'Muscle isometric contraction'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}]","[{'cui': 'C0449247', 'cui_str': 'Time course'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0022205', 'cui_str': 'Muscle isometric contraction'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0231528', 'cui_str': 'Muscle pain'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0010287', 'cui_str': 'Creatine kinase'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]",14.0,0.0317648,CMJ (p=0.025;ES=0.25) and MVIC,"[{'ForeName': 'Karine Naves de Oliveira', 'Initials': 'KNO', 'LastName': 'Goulart', 'Affiliation': 'Postgraduate Program in Sport Sciences, School of Physical Education, Physiotherapy and Occupational Therapy, Universidade Federal de Minas Gerais. Belo Horizonte (MG), Brazil.'}, {'ForeName': 'Nathalia Maria', 'Initials': 'NM', 'LastName': 'Resende', 'Affiliation': 'Physical Education Department, Universidade Federal de Lavras, Lavras (MG), Brazil.'}, {'ForeName': 'Marcos Daniel Motta', 'Initials': 'MDM', 'LastName': 'Drummond', 'Affiliation': 'Postgraduate Program in Sport Sciences, School of Physical Education, Physiotherapy and Occupational Therapy, Universidade Federal de Minas Gerais. Belo Horizonte (MG), Brazil.'}, {'ForeName': 'Luciana Maria', 'Initials': 'LM', 'LastName': 'Oliveira', 'Affiliation': 'Institute of Biological Sciences, Universidade Federal de Minas Gerais. Belo Horizonte (MG), Brazil.'}, {'ForeName': 'Fernando Vitor', 'Initials': 'FV', 'LastName': 'Lima', 'Affiliation': 'Postgraduate Program in Sport Sciences, School of Physical Education, Physiotherapy and Occupational Therapy, Universidade Federal de Minas Gerais. Belo Horizonte (MG), Brazil.'}, {'ForeName': 'Leszek Antoni', 'Initials': 'LA', 'LastName': 'Szmuchrowski', 'Affiliation': 'Postgraduate Program in Sport Sciences, School of Physical Education, Physiotherapy and Occupational Therapy, Universidade Federal de Minas Gerais. Belo Horizonte (MG), Brazil.'}, {'ForeName': 'Ricardo Toshio', 'Initials': 'RT', 'LastName': 'Fujiwara', 'Affiliation': 'Institute of Biological Sciences, Universidade Federal de Minas Gerais. Belo Horizonte (MG), Brazil.'}, {'ForeName': 'Bruno Pena', 'Initials': 'BP', 'LastName': 'Couto', 'Affiliation': 'Postgraduate Program in Sport Sciences, School of Physical Education, Physiotherapy and Occupational Therapy, Universidade Federal de Minas Gerais. Belo Horizonte (MG), Brazil.'}]",European journal of sport science,['10.1080/17461391.2020.1789227'] 2148,32594884,Comparative efficacy and safety of lactulose plus paraffin vs polyethylene glycol in functional constipation: a randomised clinical study.,"BACKGROUND Few head-to-head comparisons of the different classes of laxatives have been conducted. OBJECTIVE The objective of this work is to compare the efficacy of lactulose plus paraffin vs polyethylene glycol in the treatment of functional constipation (non-inferiority study). METHODS This randomised, parallel-group, multicentre phase 4 study recruited patients with functional constipation diagnosed according to Rome III criteria. Patients received lactulose plus paraffin or polyethylene glycol for 28 days. The primary end point was the change from baseline in the Patient Assessment of Constipation-Symptoms (PAC-SYM) score. RESULTS A total of 363 patients were randomised to lactulose plus paraffin ( n  = 179) or polyethylene glycol ( n  = 184). On day 28, the mean PAC-SYM score decreased significantly vs baseline with both treatments ( p  < 0.001). The lower boundary of the 95% CI exceeded the pre-specified limit of -0.25, therefore establishing non-inferiority of lactulose plus paraffin vs polyethylene glycol. At least one adverse event occurred in 20 patients (11.2%) in the lactulose plus paraffin group and in 26 patients (14.2%) in the polyethylene glycol group, most of which were of mild or moderate severity and unrelated to study drugs. CONCLUSION Lactulose plus paraffin may be used interchangeably with polyethylene glycol for the pharmacological treatment of functional constipation. Trial registration: EudraCT number 2015-003021-34.",2020,"On day 28, the mean PAC-SYM score decreased significantly vs baseline with both treatments ( p  < 0.001).","['patients with functional constipation diagnosed according to Rome III criteria', '363 patients', 'functional constipation (non-inferiority study', 'functional constipation', 'number 2015-003021-34']","['polyethylene glycol', 'lactulose plus paraffin or polyethylene glycol', 'Lactulose plus paraffin', 'lactulose plus paraffin vs polyethylene glycol', 'EudraCT', 'lactulose plus paraffin']","['Patient Assessment of Constipation-Symptoms (PAC-SYM) score', 'adverse event', 'mean PAC-SYM score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0401146', 'cui_str': 'Constipation - functional'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0035831', 'cui_str': 'Rome'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0237666', 'cui_str': 'Inferiority feeling'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0237753', 'cui_str': 'Number'}]","[{'cui': 'C0032483', 'cui_str': 'Polyethylene Glycols'}, {'cui': 'C0022957', 'cui_str': 'Lactulose'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0030415', 'cui_str': 'Paraffin'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",363.0,0.28967,"On day 28, the mean PAC-SYM score decreased significantly vs baseline with both treatments ( p  < 0.001).","[{'ForeName': 'T', 'Initials': 'T', 'LastName': 'Piche', 'Affiliation': 'University of Nice Sophia Antipolis, Nice, France.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Dapoigny', 'Affiliation': 'Médecine Digestive CHU Clermont-Ferrand, France.'}]",United European gastroenterology journal,['10.1177/2050640620937913'] 2149,32594915,"Consumption of whole purple and regular wheat modestly improves metabolic markers in adults with elevated high sensitivity C-reactive protein: A randomized, single-blind parallel arm study.","Whole grain wheat, in particular colored varieties, may have health benefits in adults with chronic metabolic disease risk factors. 29 overweight and obese adults with chronic inflammation (high sensitivity C-Reactive Protein (hs-CRP) > 1.0 mg/L) replaced four daily servings of refined grain food products with bran-enriched purple or regular whole wheat convenience bars (~ 41-45 g fiber, daily) for 8 weeks in a randomized, single-blind parallel arm study where body weight was maintained. Anthropometrics, blood markers of inflammation, oxidative stress, and lipemia and metabolites of anthocyanins and phenolic acids were compared at Days 1, 29 and 57 using repeated measures analysis of variance within groups and analysis of covariance between groups at Day 57, with Day 1 as a covariate. A significant reduction in interleukin-6 and increase in adiponectin were observed within the purple wheat (PW) group. Tumor necrosis factor (TNF)-α was lowered in both groups and ferulic acid concentration increased in the regular wheat (RW) group. Comparing between wheats, only plasma TNF-α and glucose differed significantly (P<0.05), i.e. TNF-α and glucose decreased with RW and PW, respectively. Consumption of PW or RW products showed potential to improve plasma markers of inflammation and oxidative stress in participants with evidence of chronic inflammation, with modest differences observed based on type of wheat.",2020,Tumor necrosis factor (TNF)-α was lowered in both groups and ferulic acid concentration increased in the regular wheat (RW) group.,"['participants with evidence of chronic inflammation', 'adults with elevated high sensitivity C-reactive protein', '29 overweight and obese adults with chronic inflammation (high sensitivity C-Reactive Protein (hs-CRP) > 1.0 mg/L) replaced four', 'adults with chronic metabolic disease risk factors']",['daily servings of refined grain food products with bran-enriched purple or regular whole wheat convenience bars'],"['interleukin-6 and increase in adiponectin', 'Anthropometrics, blood markers of inflammation, oxidative stress, and lipemia and metabolites of anthocyanins and phenolic acids', 'Tumor necrosis factor (TNF)-α', 'TNF-α and glucose', 'ferulic acid concentration', 'metabolic markers', 'plasma markers of inflammation and oxidative stress', 'plasma TNF-α and glucose']","[{'cui': 'C0332120', 'cui_str': 'Evidence of'}, {'cui': 'C0021376', 'cui_str': 'Chronic inflammation'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0439268', 'cui_str': 'mg/L'}, {'cui': 'C0559956', 'cui_str': 'Replacement - action'}, {'cui': 'C1263722', 'cui_str': 'Chronic metabolic disorder'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0007757', 'cui_str': 'Cereal'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0353942', 'cui_str': 'Bran'}, {'cui': 'C0439542', 'cui_str': 'Purple'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0043137', 'cui_str': 'Wheat'}, {'cui': 'C3831015', 'cui_str': 'Convenient'}, {'cui': 'C0001643', 'cui_str': 'Beta-2 adrenergic receptor'}]","[{'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0020473', 'cui_str': 'Hyperlipidemia'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0003161', 'cui_str': 'Anthocyanin'}, {'cui': 'C2586298', 'cui_str': 'Hydroxybenzoic acid'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0060291', 'cui_str': 'ferulic acid'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C1513159', 'cui_str': 'Metabolic marker'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}]",29.0,0.0719273,Tumor necrosis factor (TNF)-α was lowered in both groups and ferulic acid concentration increased in the regular wheat (RW) group.,"[{'ForeName': 'Tamer H', 'Initials': 'TH', 'LastName': 'Gamel', 'Affiliation': 'Dept. of Human Health & Nutritional Sciences, College of Biological Science, University of Guelph, Guelph, Ontario. N1G 2W1, CANADA.'}, {'ForeName': 'El-Sayed M', 'Initials': 'EM', 'LastName': 'Abdel-Aal', 'Affiliation': 'Guelph Research & Development Centre, Agriculture and Agri-Food Canada, 93 Stone Rd W, Guelph, Ontario. N1G 5C9, CANADA.'}, {'ForeName': 'Amy J', 'Initials': 'AJ', 'LastName': 'Tucker', 'Affiliation': 'Dept. of Human Health & Nutritional Sciences, College of Biological Science, University of Guelph, Guelph, Ontario. N1G 2W1, CANADA.'}, {'ForeName': 'Shannon M', 'Initials': 'SM', 'LastName': 'Pare', 'Affiliation': 'Dept. of Human Health & Nutritional Sciences, College of Biological Science, University of Guelph, Guelph, Ontario. N1G 2W1, CANADA.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Faughnan', 'Affiliation': 'Dept. of Human Health & Nutritional Sciences, College of Biological Science, University of Guelph, Guelph, Ontario. N1G 2W1, CANADA.'}, {'ForeName': 'Charlene D', 'Initials': 'CD', 'LastName': ""O'Brien"", 'Affiliation': 'Dept. of Human Health & Nutritional Sciences, College of Biological Science, University of Guelph, Guelph, Ontario. N1G 2W1, CANADA.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Dykun', 'Affiliation': 'Dept. of Human Health & Nutritional Sciences, College of Biological Science, University of Guelph, Guelph, Ontario. N1G 2W1, CANADA.'}, {'ForeName': 'Iwona', 'Initials': 'I', 'LastName': 'Rabalski', 'Affiliation': 'Guelph Research & Development Centre, Agriculture and Agri-Food Canada, 93 Stone Rd W, Guelph, Ontario. N1G 5C9, CANADA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Pickard', 'Affiliation': 'Infra-Ready Products Ltd, 1438 Fletcher Road, Saskatoon, Saskatchewan. S7M 5T2, CANADA.'}, {'ForeName': 'Amanda J', 'Initials': 'AJ', 'LastName': 'Wright', 'Affiliation': 'Dept. of Human Health & Nutritional Sciences, College of Biological Science, University of Guelph, Guelph, Ontario. N1G 2W1, CANADA.'}]",The British journal of nutrition,['10.1017/S0007114520002275'] 2150,32595001,"Efficacy and safety of Lianhuaqingwen capsules, a repurposed Chinese herb, in patients with coronavirus disease 2019: A multicenter, prospective, randomized controlled trial.","BACKGROUND Coronavirus disease 2019 (Covid-19) has resulted in a global outbreak. Few existing targeted medications are available. Lianhuaqingwen (LH) capsule, a repurposed marketed Chinese herb product, has been proven effective for influenza. PURPOSE To determine the safety and efficacy of LH capsule in patients with Covid-19. METHODS We did a prospective multicenter open-label randomized controlled trial on LH capsule in confirmed cases with Covid-19. Patients were randomized to receive usual treatment alone or in combination with LH capsules (4 capsules, thrice daily) for 14 days. The primary endpoint was the rate of symptom (fever, fatigue, coughing) recovery. RESULTS We included 284 patients (142 each in treatment and control group) in the full-analysis set. The recovery rate was significantly higher in treatment group as compared with control group (91.5% vs. 82.4%, p = 0.022). The median time to symptom recovery was markedly shorter in treatment group (median: 7 vs. 10 days, p < 0.001). Time to recovery of fever (2 vs. 3 days), fatigue (3 vs. 6 days) and coughing (7 vs. 10 days) was also significantly shorter in treatment group (all p < 0.001). The rate of improvement in chest computed tomographic manifestations (83.8% vs. 64.1%, p < 0.001) and clinical cure (78.9% vs. 66.2%, p = 0.017) was also higher in treatment group. However, both groups did not differ in the rate of conversion to severe cases or viral assay findings (both p > 0.05). No serious adverse events were reported. CONCLUSION In light of the safety and effectiveness profiles, LH capsules could be considered to ameliorate clinical symptoms of Covid-19.",2020,"The rate of improvement in chest computed tomographic manifestations (83.8% vs. 64.1%, p < 0.001) and clinical cure (78.9% vs. 66.2%, p = 0.017) was also higher in treatment group.","['patients with Covid-19', 'patients with coronavirus disease 2019', '284 patients (142 each in treatment and control group) in the full-analysis set']","['Lianhuaqingwen capsules, a repurposed Chinese herb', 'usual treatment alone or in combination with LH capsules']","['rate of improvement in chest computed tomographic manifestations', 'coughing', 'Time to recovery of fever', 'fatigue', 'rate of symptom (fever, fatigue, coughing) recovery', 'rate of conversion to severe cases or viral assay findings', 'Efficacy and safety', 'clinical cure', 'safety and efficacy', 'serious adverse events', 'median time to symptom recovery', 'recovery rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}]","[{'cui': 'C3852361', 'cui_str': 'lianhuaqingwen'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0019240', 'cui_str': 'Herb'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0205319', 'cui_str': 'Manifest'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0439836', 'cui_str': 'Conversions'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0521026', 'cui_str': 'viruses'}, {'cui': 'C0005507', 'cui_str': 'Bioassay'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0522501', 'cui_str': 'Massive'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]",284.0,0.213016,"The rate of improvement in chest computed tomographic manifestations (83.8% vs. 64.1%, p < 0.001) and clinical cure (78.9% vs. 66.2%, p = 0.017) was also higher in treatment group.","[{'ForeName': 'Ke', 'Initials': 'K', 'LastName': 'Hu', 'Affiliation': 'Department of Respiratory and Critical Care Medicine, Renmin Hospital of Wuhan University, Zhangzhidong Road No. 99, Wuhan 430060, Hubei province, China.'}, {'ForeName': 'Wei-Jie', 'Initials': 'WJ', 'LastName': 'Guan', 'Affiliation': 'State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, the First Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong province, 510120 PR China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Bi', 'Affiliation': 'Department of Gynaecology and Obstetrics, Wuhan Red Cross Hospital, 392 Hongkong Road, Wuhan 430015, Hubei province, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': 'Department of Respiratory and Critical Care Medicine, The First Affiliated Hospital of Nanchang University, Nanchang 330006, Jiangxi Province, China.'}, {'ForeName': 'Lanjuan', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'The First Affiliated Hospital of College of Medicine, Zhejiang province, China.'}, {'ForeName': 'Boli', 'Initials': 'B', 'LastName': 'Zhang', 'Affiliation': 'The First Teaching Hospital of Tianjin University of traditional Chinese medicine.'}, {'ForeName': 'Qingquan', 'Initials': 'Q', 'LastName': 'Liu', 'Affiliation': 'Beijing Hospital of traditional Chinese medicine, Beijing, China.'}, {'ForeName': 'Yuanlin', 'Initials': 'Y', 'LastName': 'Song', 'Affiliation': 'Zhongshan Hospital Affiliated Fudan University, Shanghai, China.'}, {'ForeName': 'Xingwang', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Beijing Ditan Hospital Capital Medical University, Beijing, China.'}, {'ForeName': 'Zhongping', 'Initials': 'Z', 'LastName': 'Duan', 'Affiliation': 'Youan Hospital Capital Medical University, Beijing, China.'}, {'ForeName': 'Qingshan', 'Initials': 'Q', 'LastName': 'Zheng', 'Affiliation': 'Shanghai University of traditional Chinese medicine, Shanghai, China.'}, {'ForeName': 'Zifeng', 'Initials': 'Z', 'LastName': 'Yang', 'Affiliation': 'State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, the First Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong province, 510120 PR China.'}, {'ForeName': 'Jingyi', 'Initials': 'J', 'LastName': 'Liang', 'Affiliation': 'State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, the First Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong province, 510120 PR China.'}, {'ForeName': 'Mingfeng', 'Initials': 'M', 'LastName': 'Han', 'Affiliation': ""Fuyang Second People's Hospital, Fuyang, China.""}, {'ForeName': 'Lianguo', 'Initials': 'L', 'LastName': 'Ruan', 'Affiliation': 'Wuhan Jinyintan Hospital, Wuhan, Hubei province, China.'}, {'ForeName': 'Chaomin', 'Initials': 'C', 'LastName': 'Wu', 'Affiliation': 'Zhongshan Hospital Affiliated Fudan University, Shanghai, China.'}, {'ForeName': 'Yunting', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Respiratory and Critical Care Medicine, Renmin Hospital of Wuhan University, Zhangzhidong Road No. 99, Wuhan 430060, Hubei province, China.'}, {'ForeName': 'Zhen-Hua', 'Initials': 'ZH', 'LastName': 'Jia', 'Affiliation': 'Hebei Yiling Hospital, National Key Laboratory of Collateral Disease Research and Innovative Chinese Medicine, Shijiazhuang, Hebei province 050035 PR China. Electronic address: jzhjiazhenhua@163.com.'}, {'ForeName': 'Nan-Shan', 'Initials': 'NS', 'LastName': 'Zhong', 'Affiliation': 'State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, the First Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong province, 510120 PR China. Electronic address: nanshan@vip.163.com.'}]",Phytomedicine : international journal of phytotherapy and phytopharmacology,['10.1016/j.phymed.2020.153242'] 2151,32595160,Protocol for creating new warnings on cigarette packs and evaluating their efficacy in a randomised experimental setting.,"INTRODUCTION Tobacco smoking is one of the leading causes of preventable death. This is not inevitable as tobacco control tools have become more powerful and more effective. Among these, warnings on cigarette packs have proven to be somewhat effective. Our objective is to increase the efficacy of antismoking warnings by using innovative psychological approaches and to create an experimental setting for the evaluation of these new warnings based on behavioural indicators. METHODS AND ANALYSIS First, we created new warnings based on three categories of motivational leverage and on harm reduction. New warnings with innovative texts and pictures were designed for each category and inserted on plain packs. We will then use standard indicators to compare their effect to that of control packs: plain pack without warning, plain pack with conventional warning and branded pack with conventional warning. Second, the novelty of our approach will consist in designing an experimental protocol that uses monetary incentives to evaluate the effect of warnings. Subjects will be able to 'sacrifice' part of their participation defrayal to purchase a good whose subjective value is related to one's attitude towards smoking. These monetarily incentivised measures are designed to assess smokers' immediate/mid-term intention to quit and non-smokers' aversion to smoking. In both cases, the monetary amounts individuals accept to sacrifice may be a more reliable measure than declarative responses, which may be distorted by several hypothetical biases. In the end, we should be able to robustly measure the impact of our new warnings between intervention and control groups by using both traditional indicators and our new monetarily incentivised measure. ETHICS AND DISSEMINATION The ethics committee of the Groupement des Hôpitaux de l'Institut Catholique de Lille approved the research protocol on 5 July 2019 (CIER 2019-22). Results will be presented at scientific meetings and published.",2020,"In the end, we should be able to robustly measure the impact of our new warnings between intervention and control groups by using both traditional indicators and our new monetarily incentivised measure. ",[],"['control packs: plain pack without warning, plain pack with conventional warning and branded pack with conventional warning']",[],[],"[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184967', 'cui_str': 'Insertion of pack'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}]",[],,0.014774,"In the end, we should be able to robustly measure the impact of our new warnings between intervention and control groups by using both traditional indicators and our new monetarily incentivised measure. ","[{'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Ben Lakhdar', 'Affiliation': 'LEM UMR 9221 CNRS, University of Lille, Lille, Hauts-de-France, France christian.ben-lakhdar@univ-lille.fr.'}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Deplancke', 'Affiliation': 'ETHICS EA 7446, Lille Catholic University, Lille, Hauts-de-France, France.'}, {'ForeName': 'Fabrice', 'Initials': 'F', 'LastName': 'Le Lec', 'Affiliation': 'ETHICS EA 7446, Lille Catholic University, Lille, Hauts-de-France, France.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Massin', 'Affiliation': 'LEM UMR 9221 CNRS, Artois University, Arras, Hauts-de-France, France.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Piermatteo', 'Affiliation': 'ETHICS EA 7446, Lille Catholic University, Lille, Hauts-de-France, France.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Vaillant', 'Affiliation': 'LEM UMR 9221 CNRS, University of Lille, Lille, Hauts-de-France, France.'}]",BMJ open,['10.1136/bmjopen-2019-036166'] 2152,32595159,Economic evaluation alongside the Probiotics to Prevent Severe Pneumonia and Endotracheal Colonization Trial (E-PROSPECT): study protocol.,"INTRODUCTION Ventilator-associated pneumonia (VAP) is a common healthcare-associated infection in the intensive care unit (ICU). Probiotics are defined as live microorganisms that may confer health benefits when ingested. Prior randomised trials suggest that probiotics may prevent infections such as VAP and Clostridioides difficile -associated diarrhoea (CDAD). PROSPECT (Probiotics to Prevent Severe Pneumonia and Endotracheal Colonization Trial) is a multicentre, double-blinded, randomised controlled trial comparing the efficacy of the probiotic Lactobacillus rhamnosus GG with usual care versus usual care without probiotics in preventing VAP and other clinically important outcomes in critically ill patients admitted to the ICU. METHODS AND ANALYSIS The objective of E-PROSPECT is to determine the incremental cost-effectiveness of L. rhamnosus GG plus usual care versus usual care without probiotics in critically ill patients. E-PROSPECT will be performed from the public healthcare payer's perspective over a time horizon from ICU admission to hospital discharge.We will determine probabilities of in-ICU and in-hospital events from all patients alongside PROSPECT. We will retrieve unit costs for each resource use item using jurisdiction-specific public databases, supplemented by individual site unit costs if such databases are unavailable. Direct costs will include medications, personnel costs, radiology/laboratory testing, operative/non-operative procedures and per-day hospital 'hoteling' costs not otherwise encompassed. The primary outcome is the incremental cost per VAP prevented between the two treatment groups. Other clinical events such as CDAD, antibiotic-associated diarrhoea and in-hospital mortality will be included as secondary outcomes. We will perform pre-specified subgroup analyses (medical/surgical/trauma; age; frailty status; antibiotic use; prevalent vs no prevalent pneumonia) and probabilistic sensitivity analyses for VAP, then generate confidence intervals using the non-parametric bootstrapping approach. ETHICS AND DISSEMINATION Study approval for E-PROSPECT was granted by the Hamilton Integrated Research Ethics Board of McMaster University on 29 July 2019. Informed consent was obtained from the patient or substitute decision-maker in PROSPECT. The findings of this study will be published in peer-reviewed journals. TRIAL REGISTRATION NUMBER NCT01782755; Pre-results.",2020,The objective of E-PROSPECT is to determine the incremental cost-effectiveness of ,"['critically ill patients admitted to the ICU', 'critically ill patients']","['probiotic Lactobacillus rhamnosus GG with usual care versus usual care without probiotics', 'L. rhamnosus GG plus usual care versus usual care without probiotics', 'PROSPECT (Probiotics']",['incremental cost per VAP'],"[{'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}]","[{'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C1629836', 'cui_str': 'Lactobacillus rhamnosus GG'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0087153', 'cui_str': 'Ventilator'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}]",,0.217057,The objective of E-PROSPECT is to determine the incremental cost-effectiveness of ,"[{'ForeName': 'Vincent Issac', 'Initials': 'VI', 'LastName': 'Lau', 'Affiliation': 'Department of Critical Care, University of Alberta Faculty of Medicine and Dentistry, Edmonton, Alberta, Canada vinceissaclau@gmail.com.'}, {'ForeName': 'Deborah J', 'Initials': 'DJ', 'LastName': 'Cook', 'Affiliation': 'Department of Health Research Methods, Evidence and Impact, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Fowler', 'Affiliation': 'Sunnybrook Health Sciences Institute, Sunnybrook Research Institute, Toronto, Ontario, Canada.'}, {'ForeName': 'Bram', 'Initials': 'B', 'LastName': 'Rochwerg', 'Affiliation': 'Department of Health Research Methods, Evidence and Impact, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Jennie', 'Initials': 'J', 'LastName': 'Johnstone', 'Affiliation': 'Public Health Ontario, University of Toronto Dalla Lana School of Public Health, Toronto, Ontario, Canada.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Lauzier', 'Affiliation': 'Population Health and Optimal Health Practices Research Unit (Trauma-Emergency-Critical Care Medicine), Centre de Recherche du CHU de Québec-Université Laval, Quebec, Quebec, Canada.'}, {'ForeName': 'John C', 'Initials': 'JC', 'LastName': 'Marshall', 'Affiliation': 'Department of Surgery, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Basmaji', 'Affiliation': 'Department of Medicine, Division of Critical Care, Western University, London, Ontario, Canada.'}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Heels-Ansdell', 'Affiliation': 'Department of Health Research Methods, Evidence and Impact, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Lehana', 'Initials': 'L', 'LastName': 'Thabane', 'Affiliation': 'Department of Health Research Methods, Evidence and Impact, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Xie', 'Affiliation': 'Department of Health Research Methods, Evidence and Impact, McMaster University, Hamilton, Ontario, Canada.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ open,['10.1136/bmjopen-2019-036047'] 2153,32595176,Efficacy and Safety of Left Atrial Appendage Closure With WATCHMAN in Japanese Nonvalvular Atrial Fibrillation Patients　- Final 2-Year Follow-up Outcome Data From the SALUTE Trial.,"BACKGROUND The SALUTE trial was a prospective, multicenter, single-arm trial to confirm the safety and efficacy of the WATCHMAN left atrial appendage closure (LAAC) device for stroke prevention in patients with nonvalvular atrial fibrillation (NVAF) in Japan.Methods and Results:A total of 54 subjects (including 12 roll-in subjects) with a WATCHMAN implant procedure were followed in 10 investigational centers. Follow-up visits were performed up to 2 years post-implant. The baseline CHA 2 DS 2 -VASc score was 3.6±1.6 and the baseline HAS-BLED score was 3.0±1.1. All 42 subjects in the intention to treat (ITT) cohort underwent successful implantation of the LAAC device without any serious complications, achieving the prespecified performance goal. The effective LAAC rate was maintained at 100% from 45 days to 12 months post-implant, achieving the prespecified performance goal. During follow-up, 1 subject died of heart failure, and 3 had ischemic strokes, but there were no cases of hemorrhagic stroke or systemic embolism. All events were adjudicated as unrelated to the WATCHMAN device/procedure by the independent Clinical Events Committee. All 3 ischemic strokes were classified as nondisabling based on no change in the modified Rankin scale score. CONCLUSIONS Final results of the SALUTE trial demonstrated that the WATCHMAN LAAC device is an effective and safe alternative nonpharmacological therapy for stroke risk reduction in Japanese NVAF patients who are not optimal candidates for lifelong anticoagulation. (Trial Registration: clinicaltrials.gov Identifier NCT03033134).",2020,"All 42 subjects in the intention to treat (ITT) cohort underwent successful implantation of the LAAC device without any serious complications, achieving the prespecified performance goal.","['Japanese NVAF patients who are not optimal candidates for lifelong anticoagulation', 'Japanese Nonvalvular Atrial Fibrillation Patients', 'patients with nonvalvular atrial fibrillation (NVAF) in Japan', '54 subjects (including 12 roll-in subjects) with a WATCHMAN implant procedure were followed in 10 investigational centers', 'All 42 subjects in the intention to treat (ITT) cohort underwent']","['Left Atrial Appendage Closure', 'left atrial appendage closure (LAAC) device', 'successful implantation of the LAAC device']","['Efficacy and Safety', 'baseline CHA 2 DS 2 -VASc score', 'hemorrhagic stroke or systemic embolism', 'safety and efficacy', 'modified Rankin scale score', 'effective LAAC rate']","[{'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4274169', 'cui_str': 'Lifelong'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0335390', 'cui_str': 'Watchman'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}]","[{'cui': 'C4759306', 'cui_str': 'Left atrial appendage closure'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C4523927', 'cui_str': 'Atrial appendage closure'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0574369', 'cui_str': 'Chamorro language'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0553692', 'cui_str': 'Haemorrhagic stroke'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0013922', 'cui_str': 'Embolism'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C4523927', 'cui_str': 'Atrial appendage closure'}]",54.0,0.0923228,"All 42 subjects in the intention to treat (ITT) cohort underwent successful implantation of the LAAC device without any serious complications, achieving the prespecified performance goal.","[{'ForeName': 'Kazutaka', 'Initials': 'K', 'LastName': 'Aonuma', 'Affiliation': 'Cardiovascular Division, University of Tsukuba Hospital.'}, {'ForeName': 'Hiro', 'Initials': 'H', 'LastName': 'Yamasaki', 'Affiliation': 'Cardiovascular Division, University of Tsukuba Hospital.'}, {'ForeName': 'Masato', 'Initials': 'M', 'LastName': 'Nakamura', 'Affiliation': 'Division of Cardiovascular Medicine, Toho University Ohashi Medical Center.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Matsumoto', 'Affiliation': 'Department of Cardiology, Sendai Kousei Hospital.'}, {'ForeName': 'Morimasa', 'Initials': 'M', 'LastName': 'Takayama', 'Affiliation': 'Department of Cardiology, Sakakibara Heart Institute.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Ando', 'Affiliation': 'Division of Cardiology, Kokura Memorial Hospital.'}, {'ForeName': 'Kenzo', 'Initials': 'K', 'LastName': 'Hirao', 'Affiliation': 'Department of Cardiology, AOI Universal Hospital.'}, {'ForeName': 'Masahiko', 'Initials': 'M', 'LastName': 'Goya', 'Affiliation': 'Department of Cardiovascular Medicine, Tokyo Medical and Dental University.'}, {'ForeName': 'Yoshihiro', 'Initials': 'Y', 'LastName': 'Morino', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Iwate Medical University.'}, {'ForeName': 'Kentaro', 'Initials': 'K', 'LastName': 'Hayashida', 'Affiliation': 'Department of Cardiology, Keio University School of Medicine.'}, {'ForeName': 'Kengo', 'Initials': 'K', 'LastName': 'Kusano', 'Affiliation': 'Department of Cardiovascular Medicine, National Cerebral and Cardiovascular Center.'}, {'ForeName': 'Yutaka', 'Initials': 'Y', 'LastName': 'Gomi', 'Affiliation': 'Boston Scientific Japan K.K.'}, {'ForeName': 'Michael L', 'Initials': 'ML', 'LastName': 'Main', 'Affiliation': ""Saint Luke's Mid America Heart Institute.""}, {'ForeName': 'Takahiro', 'Initials': 'T', 'LastName': 'Uchida', 'Affiliation': ""Department of Cardiology, Tokyo Women's Medical University.""}, {'ForeName': 'Shigeru', 'Initials': 'S', 'LastName': 'Saito', 'Affiliation': 'Division of Cardiology & Catheterization Laboratories, Shonan Kamakura General Hospital.'}]",Circulation journal : official journal of the Japanese Circulation Society,['10.1253/circj.CJ-20-0196'] 2154,32595189,The orthodontic bonding properties of human enamel after cryopreservation.,"The aim was to investigate the effect of cryopreservation on the enamel bonding properties of orthodontic brackets. Sixty-six human premolars were randomly allocated to a control group or a cryopreserved group. Conventional stainless-steel orthodontic brackets were bonded with a light cure adhesive on the buccal side of the premolars. The shear bond strength (SBS) was determined at a crosshead speed of 1 mm/min. The SBS and adhesive remnant index (ARI) were evaluated respectively by an independent samples t test and Fisher's exact test (α≤0.05). The mean failure load was lower in the cryopreserved group. However, this difference in SBS was not significant (p=0.443). In both groups, the ARI mostly indicated a failure at the enamel-adhesive interface. The mean ARI scores for both groups were not significantly different (p=0.099). Within the limitations of this macro bond strength testing, it can be concluded that cryopreservation does not significantly affect the bonding properties of enamel.",2020,The mean ARI scores for both groups were not significantly different (p=0.099).,"['Sixty-six human premolars', 'human enamel after cryopreservation']",[],"['SBS', 'mean ARI scores', 'mean failure load', 'SBS and adhesive remnant index (ARI', 'shear bond strength (SBS']","[{'cui': 'C4517841', 'cui_str': '66'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C1704302', 'cui_str': 'Structure of premolar tooth'}, {'cui': 'C0011350', 'cui_str': 'Enamel structure'}, {'cui': 'C0010405', 'cui_str': 'Cryopreservation'}]",[],"[{'cui': 'C0175735', 'cui_str': 'Scissors'}, {'cui': 'C0028758', 'cui_str': 'Bonding (Psychology)'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001516', 'cui_str': 'Adhesive'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0231174', 'cui_str': 'Failure'}]",66.0,0.0395137,The mean ARI scores for both groups were not significantly different (p=0.099).,"[{'ForeName': 'Noëmi M C', 'Initials': 'NMC', 'LastName': 'De Roo', 'Affiliation': 'Oral Health Sciences, Department of Orthodontics, Ghent University.'}, {'ForeName': 'Eline', 'Initials': 'E', 'LastName': 'Deboosere', 'Affiliation': 'Oral Health Sciences, Department of Orthodontics, Ghent University.'}, {'ForeName': 'Laurent A M', 'Initials': 'LAM', 'LastName': 'Thierens', 'Affiliation': 'Oral Health Sciences, Department of Orthodontics, Ghent University.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Vercruysse', 'Affiliation': 'Biomaterials Group, Department of Basic Medical Sciences, Ghent University.'}, {'ForeName': 'Liesbeth', 'Initials': 'L', 'LastName': 'Temmerman', 'Affiliation': 'Oral Health Sciences, Department of Orthodontics, Ghent University.'}, {'ForeName': 'Ronald M H', 'Initials': 'RMH', 'LastName': 'Verbeeck', 'Affiliation': 'Biomaterials Group, Department of Basic Medical Sciences, Ghent University.'}, {'ForeName': 'Guy A M', 'Initials': 'GAM', 'LastName': 'De Pauw', 'Affiliation': 'Oral Health Sciences, Department of Orthodontics, Ghent University.'}]",Dental materials journal,['10.4012/dmj.2019-208'] 2155,32595205,Clinical Efficacy of Combined Hysteroscopic and Laparoscopic Surgery and Reversible Ligation of the Uterine Artery for Excision and Repair of Uterine Scar in Patients with Type II and III Cesarean Scar Pregnancy.,"BACKGROUND With the changes in China's family planning policy, the incidence of cesarean scar pregnancy (CSP) significantly increased in recent years. The present study aimed to investigate the clinical efficacy of combined hysteroscopic and laparoscopic surgery and reversible ligation of the uterine artery for cesarean scar excision and repair in patients with type II and III CSP. MATERIAL AND METHODS This was a retrospective study of 173 patients with type II and III CSP. They were assigned to the hysteroscopy and laparoscopy group (group A), hysteroscopy group (group B), and curettage group (group C) according to the surgery they underwent. The surgical indicators (intraoperative bleeding volume and hospital stay), postoperative recovery (time of serum ß-hCG returning to the normal, postoperative residual lesion, the thickness of the uterine scar, and recovery time of menstruation), and the postoperative complications were compared among the 3 groups. RESULTS In patients with type II and III CSP, significant differences (P<0.05) were observed between group A vs. groups B and C in terms of the time of serum ß-HCG returning to normal, postoperative residual lesions, the thickness of the uterine scar, and recovery time of menstruation, while there were no significant differences in intraoperative bleeding volume and postoperative hospital stay (P>0.05). CONCLUSIONS For patients with type II and III CSP, hysteroscopy and laparoscopy surgery and reversible ligation of the uterine artery achieved better clinical outcomes than hysteroscopy or curettage with respect to postoperative recovery. This could be suitable for patients with CSP and desire for fertility.",2020,"In patients with type II and III CSP, significant differences (P<0.05) were observed between group A vs. groups B and C in terms of the time of serum ß-HCG returning to normal, postoperative residual lesions, the thickness of the uterine scar, and recovery time of menstruation, while there were no significant differences in intraoperative bleeding volume and postoperative hospital stay (P>0.05).","['patients with type II and III CSP', 'patients with CSP and desire for fertility', '173 patients with type II and III CSP', 'Patients with Type II and III Cesarean Scar Pregnancy']","['Combined Hysteroscopic and Laparoscopic Surgery and Reversible Ligation of the Uterine Artery for Excision and Repair of Uterine Scar', 'hysteroscopy and laparoscopy', 'hysteroscopy group', 'combined hysteroscopic and laparoscopic surgery and reversible ligation of the uterine artery for cesarean scar excision and repair']","['cesarean scar pregnancy (CSP', 'time of serum ß-HCG returning to normal, postoperative residual lesions, the thickness of the uterine scar, and recovery time of menstruation', 'intraoperative bleeding volume and postoperative hospital stay', 'surgical indicators (intraoperative bleeding volume and hospital stay), postoperative recovery (time of serum ß-hCG returning to the normal, postoperative residual lesion, the thickness of the uterine scar, and recovery time of menstruation), and the postoperative complications']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0008767', 'cui_str': 'Scarring'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0015895', 'cui_str': 'Ability to conceive'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0751429', 'cui_str': 'Laparoscopic surgery'}, {'cui': 'C0205343', 'cui_str': 'Reversible'}, {'cui': 'C0023690', 'cui_str': 'Ligation'}, {'cui': 'C0226378', 'cui_str': 'Structure of uterine artery'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0426015', 'cui_str': 'Scarring of uterus'}, {'cui': 'C0020710', 'cui_str': 'Hysteroscopy'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0852828', 'cui_str': 'Excision of scar'}]","[{'cui': 'C0008767', 'cui_str': 'Scarring'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C1141639', 'cui_str': 'Human chorionic gonadotropin'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0426015', 'cui_str': 'Scarring of uterus'}, {'cui': 'C0025344', 'cui_str': 'Menstruation'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}]",173.0,0.0289059,"In patients with type II and III CSP, significant differences (P<0.05) were observed between group A vs. groups B and C in terms of the time of serum ß-HCG returning to normal, postoperative residual lesions, the thickness of the uterine scar, and recovery time of menstruation, while there were no significant differences in intraoperative bleeding volume and postoperative hospital stay (P>0.05).","[{'ForeName': 'Lina', 'Initials': 'L', 'LastName': 'Huang', 'Affiliation': ""Department of Obstetrics and Gynecology, Ningbo Women's and Children's Hospital, Ningbo, Zhejiang, China (mainland).""}, {'ForeName': 'Lingjun', 'Initials': 'L', 'LastName': 'Zhao', 'Affiliation': ""Department of Obstetrics and Gynecology, Ningbo Women's and Children's Hospital, Ningbo, Zhejiang, China (mainland).""}, {'ForeName': 'Huiwei', 'Initials': 'H', 'LastName': 'Shi', 'Affiliation': ""Department of Obstetrics and Gynecology, Ningbo Women's and Children's Hospital, Ningbo, Zhejiang, China (mainland).""}]",Medical science monitor : international medical journal of experimental and clinical research,['10.12659/MSM.924076'] 2156,32595366,Complication Risk in Secondary Thyroid Surgery.,"Objectives Secondary thyroid surgery is rare, compared with primary thyroid surgery. However, secondary surgery has a greater risk of complications due to the formation of scar tissue as well as increased fragility of the tissues following the previous surgery. Several surgical techniques and strategies have been recommended to decrease the complication rate associated with secondary surgery. The aim of this study was to evaluate the complication rate in patients who underwent secondary thyroid surgery using a lateral approach and intraoperative nerve monitoring (IONM). Methods The data of 44 patients who underwent secondary surgical intervention after thyroid surgery performed for benign or malignant thyroid disease (Group 1), and of 44 patients who underwent primary surgery (Group 2) were compared. Lobectomy patients with a histopathological result of malignant disease, whom were applied completion thyroidectomy were excluded from the study. Secondary surgery was performed using a lateral approach. Access was achieved between the anterior edge of the sternocleidomastoid muscle and the strap muscles. In primary surgery, the thyroid lodge was entered through the midline. Standard IONM was applied in all cases. Hypocalcemia was defined as a serum calcium level of ≤8 mg/dL within the first postoperative 48 hours, regardless of clinical symptoms. Transient and permanent recurrent laryngeal nerve paralysis was evaluated based on the number of nerves at risk. The lobectomy was considered to be high-risk with the presence of recurrence, Graves' disease, substernal goiter, and application of central dissection. Results The mean age of Group 1 and 2 was 49.9±14.1 years and 45±12.6 years , respectively (range: 22-90 years; p=0.69). Female patients constituted 90.9% (n=40) of the population in Group 1 and 75% (n=33) of the patient population in Group 2 (p=0.87). In Group 1, 11 (25%) patients, and 7 (15.9%) patients in Group 2 underwent surgical intervention due to the presence of a malignant disease (p=0.29). Bilateral intervention was applied in 26 (59.1%) patients in Group 1 and 28 (63.6%) patients in Group 2. The rate of transient and permanent hypocalcemia in Groups 1 and 2 was 34.1% (n=15) vs 22.5%, and 2.5% (n=1) vs 0%, respectively, without any significant intergroup difference (p=0.237, p=1). In Group 1, 71 lobes were operated on, and there were 72 in Group 2. All of the interventions in Group 1 (100%), and 31.9% (n=23) of those in Group 2 were high-risk, and there was a significant intergroup difference (p<0.0001). The rate of transient and permanent vocal cord paralysis were 4.2% (n=3) vs 2.8% (n=2) and 6.9 % (n=5) vs 0% in Groups 1 and 2, respectively (p=0.719; p=0.245). Conclusion When performed with a meticulous and attentive technique, secondary surgical intervention can be applied without increasing the incidence of permanent complications. Though there is substantial risk associated with all of these procedures, the rate of vocal cord paralysis was similar to that seen after primary intervention, and was thought to be related to surgical experience and technique, as well as the use of IONM.",2018,"The rate of transient and permanent vocal cord paralysis were 4.2% (n=3) vs 2.8% (n=2) and 6.9 % (n=5) vs 0% in Groups 1 and 2, respectively (p=0.719; p=0.245). ","['Lobectomy patients with a histopathological result of malignant disease, whom were applied completion thyroidectomy were excluded from the study', '44 patients who underwent secondary surgical intervention after thyroid surgery performed for benign or malignant thyroid disease (Group 1), and of 44 patients who underwent', 'patients who underwent secondary thyroid surgery using a lateral approach and intraoperative nerve monitoring (IONM']","['surgical intervention', 'primary surgery']","['rate of transient and permanent vocal cord paralysis', 'thyroid lodge', 'rate of vocal cord paralysis', 'complication rate', 'rate of transient and permanent hypocalcemia', 'Complication Risk', 'Hypocalcemia']","[{'cui': 'C0023928', 'cui_str': 'Lobectomy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0205282', 'cui_str': 'Malignant'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C4304448', 'cui_str': 'Completion thyroidectomy'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0193769', 'cui_str': 'Operation on thyroid gland'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0205183', 'cui_str': 'Benign'}, {'cui': 'C0040128', 'cui_str': 'Disorder of thyroid gland'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C0205514', 'cui_str': 'Lateral approach'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0000741', 'cui_str': 'Abducens nerve structure'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}]","[{'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0040704', 'cui_str': 'Transients'}, {'cui': 'C0205355', 'cui_str': 'Permanent'}, {'cui': 'C0042928', 'cui_str': 'Vocal cord paralysis'}, {'cui': 'C0040132', 'cui_str': 'Thyroid structure'}, {'cui': 'C0020056', 'cui_str': 'Housed'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0020598', 'cui_str': 'Hypocalcemia'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",,0.0396152,"The rate of transient and permanent vocal cord paralysis were 4.2% (n=3) vs 2.8% (n=2) and 6.9 % (n=5) vs 0% in Groups 1 and 2, respectively (p=0.719; p=0.245). ","[{'ForeName': 'Nurcihan', 'Initials': 'N', 'LastName': 'Aygün', 'Affiliation': 'Department of General Surgery, Siverek State Hospital, Şanlıurfa, Turkey.'}, {'ForeName': 'Evren', 'Initials': 'E', 'LastName': 'Besler', 'Affiliation': 'Health Sciences University, İstanbul Şişli Hamidiye Etfal Health Practice and Research Center, İstanbul, Turkey.'}, {'ForeName': 'Gürkan', 'Initials': 'G', 'LastName': 'Yetkin', 'Affiliation': 'Health Sciences University, İstanbul Şişli Hamidiye Etfal Health Practice and Research Center, İstanbul, Turkey.'}, {'ForeName': 'Mehmet', 'Initials': 'M', 'LastName': 'Mihmanlı', 'Affiliation': 'Health Sciences University, İstanbul Şişli Hamidiye Etfal Health Practice and Research Center, İstanbul, Turkey.'}, {'ForeName': 'Adnan', 'Initials': 'A', 'LastName': 'İşgör', 'Affiliation': 'Department of General Surgery, Bahçeşehir University Faculty of Medicine, İstanbul, Turkey.'}, {'ForeName': 'Mehmet', 'Initials': 'M', 'LastName': 'Uludağ', 'Affiliation': 'Health Sciences University, İstanbul Şişli Hamidiye Etfal Health Practice and Research Center, İstanbul, Turkey.'}]",Sisli Etfal Hastanesi tip bulteni,['10.14744/SEMB.2017.87609'] 2157,32595442,Hemoglobin Concentration May Affect the Effect of Atorvastin on Chronic Subdural Hematoma After Burr-Hole Drainage at High Altitude.,"Objective Chronic subdural hematoma (CSDH) is a common disease. Atorvastatin calcium can increase CSDH absorption. However, whether atorvastatin can increase hematoma absorption and reduce recurrence at high altitudes is not clear. Methods After burr-hole drainage, CSDH patients were divided into an atorvastatin group and a control group. Follow-up computed tomography (CT) was performed on day 1, months 1, 2, and 3 after surgery. Then, the recurrence rate, poor therapeutic effect, time to recurrence, poor surgical result, recurrence with operation, CSDH volume, and Markwalder grading scale score (MGSS) were calculated, and related risk factors were analyzed. Results The non-recurrent and recurrent patients in the control group differed significantly in terms of the hemoglobin concentration (HB) [176.24 ± 16.43 vs. 194.25 ± 12.34 (g/L), p < 0.01], CT value [41.92 ± 10.76 vs. 34.12 ± 8.78 (Hu), p < 0.01], and low-density time [3.88 ± 1.04 vs. 5.50 ± 0.87 (d), p < 0.01]. The non-recurrent and recurrent patients in the atorvastatin group differed significantly in terms of the HB [172.66 ± 16.41 vs. 190.45 ± 10.23 (g/L), p < 0.01], CT value [38.91 ± 7.16 vs. 29.50 ± 8.61 (Hu), p < 0.01], and mixed [2 vs. 4 (n), p < 0.05] and low-density time [4.09 ± 0.75 vs. 5.45 ± 1.12 (d), p < 0.01]. The logistic regression analysis showed that HB [odds ratio, 1.14; 95% confidence interval (CI), 1.04-1.25 in the control group, odds ratio, 1.13; 95% CI, 1.03-1.23 in the atorvastatin group] and low-density time (odds ratio, 3.53; 95% CI, 1.42-8.74 in the control group, odds ratio, 2.53; 95% CI, 1.10-5.80 in the atorvastatin group) were possible risk factors for the two groups. The receiver operating characteristic curves showed that the area under the receiver operating characteristic curve values for the HB, CT value (Hu), and low-density time were 0.812, 0.702, and 0.755 for all subjects; 0.812, 0.719, and 0.790 for the control group; and 0.807, 0.682, and 0.756 for the atorvastatin group, respectively. The postoperative follow-up results showed that there was no significant difference in the recurrence rate, poor therapeutic effect, time to recurrence, poor surgical result, recurrence with operation, CSDH volume, or MGSS between the two groups. Conclusion The effect of atorvastatin was not significant after the operation. The risk factors for CSDH recurrence were the HB and low-density time. The HB was the most specific and sensitive predictor of CSDH recurrence.",2020,"The postoperative follow-up results showed that there was no significant difference in the recurrence rate, poor therapeutic effect, time to recurrence, poor surgical result, recurrence with operation, CSDH volume, or MGSS between the two groups. ",[],"['atorvastatin', 'Atorvastatin calcium', 'Atorvastin', 'Follow-up computed tomography (CT']","['Chronic Subdural Hematoma', 'CSDH absorption', 'hemoglobin concentration (HB', 'low-density time', 'recurrence rate, poor therapeutic effect, time to recurrence, poor surgical result, recurrence with operation, CSDH volume, or MGSS', 'hematoma absorption and reduce recurrence', 'HB, CT value (Hu), and low-density time', 'recurrence rate, poor therapeutic effect, time to recurrence, poor surgical result, recurrence with operation, CSDH volume, and Markwalder grading scale score (MGSS']",[],"[{'cui': 'C0286651', 'cui_str': 'atorvastatin'}, {'cui': 'C0286650', 'cui_str': 'Atorvastatin calcium'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}]","[{'cui': 'C0749095', 'cui_str': 'Subdural Hematoma, Chronic'}, {'cui': 'C0237442', 'cui_str': 'Physiological Absorption'}, {'cui': 'C1318517', 'cui_str': 'Hemoglobin concentration, dipstick - finding'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0018944', 'cui_str': 'Hematoma'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",,0.0252162,"The postoperative follow-up results showed that there was no significant difference in the recurrence rate, poor therapeutic effect, time to recurrence, poor surgical result, recurrence with operation, CSDH volume, or MGSS between the two groups. ","[{'ForeName': 'Linjie', 'Initials': 'L', 'LastName': 'Wei', 'Affiliation': 'Department of Neurosurgery, Southwest Hospital, Third Military Medical University (Army Medical University), Chongqing, China.'}, {'ForeName': 'Chi', 'Initials': 'C', 'LastName': 'Lin', 'Affiliation': ""Department of Neurosurgery, First People's Hospital of Honghe City, Yunnan, China.""}, {'ForeName': 'Mingfeng', 'Initials': 'M', 'LastName': 'Zhong', 'Affiliation': ""Department of Function, The People's Hospital of Weiyuan County, Sichuan, China.""}, {'ForeName': 'Jianbo', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Neurosurgery, The General Hospital of Southern Theater Command PLA, Guangzhou, China.'}, {'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Zhu', 'Affiliation': 'Department of Neurosurgery, Southwest Hospital, Third Military Medical University (Army Medical University), Chongqing, China.'}]",Frontiers in neuroscience,['10.3389/fnins.2020.00503'] 2158,32595461,The Influence of Reward on Facial Mimicry: No Evidence for a Significant Effect of Oxytocin.,"Recent findings suggest a role of oxytocin on the tendency to spontaneously mimic the emotional facial expressions of others. Oxytocin-related increases of facial mimicry, however, seem to be dependent on contextual factors. Given previous literature showing that people preferentially mimic emotional expressions of individuals associated with high (vs. low) rewards, we examined whether the reward value of the mimicked agent is one factor influencing the oxytocin effects on facial mimicry. To test this hypothesis, 60 male adults received 24 IU of either intranasal oxytocin or placebo in a double-blind, between-subject experiment. Next, the value of male neutral faces was manipulated using an associative learning task with monetary rewards. After the reward associations were learned, participants watched videos of the same faces displaying happy and angry expressions. Facial reactions to the emotional expressions were measured with electromyography. We found that participants judged as more pleasant the face identities associated with high reward values than with low reward values. However, happy expressions by low rewarding faces were more spontaneously mimicked than high rewarding faces. Contrary to our expectations, we did not find a significant direct effect of intranasal oxytocin on facial mimicry, nor on the reward-driven modulation of mimicry. Our results support the notion that mimicry is a complex process that depends on contextual factors, but failed to provide conclusive evidence of a role of oxytocin on the modulation of facial mimicry.",2020,"Contrary to our expectations, we did not find a significant direct effect of intranasal oxytocin on facial mimicry, nor on the reward-driven modulation of mimicry.",['60 male adults received 24 IU of either'],"['intranasal oxytocin or placebo', 'oxytocin', 'Oxytocin', 'intranasal oxytocin']",[],"[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0442118', 'cui_str': 'Intranasal approach'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],60.0,0.0742936,"Contrary to our expectations, we did not find a significant direct effect of intranasal oxytocin on facial mimicry, nor on the reward-driven modulation of mimicry.","[{'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Trilla', 'Affiliation': 'Berlin School of Mind and Brain, Humboldt-Universität zu Berlin, Berlin, Germany.'}, {'ForeName': 'Hanna', 'Initials': 'H', 'LastName': 'Drimalla', 'Affiliation': 'Berlin School of Mind and Brain, Humboldt-Universität zu Berlin, Berlin, Germany.'}, {'ForeName': 'Malek', 'Initials': 'M', 'LastName': 'Bajbouj', 'Affiliation': 'Center for Affective Neuroscience, Department of Psychiatry, Charité-Universitätsmedizin, Campus Benjamin Franklin, Berlin, Germany.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Dziobek', 'Affiliation': 'Berlin School of Mind and Brain, Humboldt-Universität zu Berlin, Berlin, Germany.'}]",Frontiers in behavioral neuroscience,['10.3389/fnbeh.2020.00088'] 2159,32595488,Neural Mechanisms of the Contextual Interference Effect and Parameter Similarity on Motor Learning in Older Adults: An EEG Study.,"The purpose of this study was to investigate the neural mechanisms of the contextual interference effect (CIE) and parameter similarity on motor learning in older adults. Sixty older adults (mean age, 67.68 ± 3.95 years) were randomly assigned to one of six experimental groups: blocked-similar, algorithm-similar, random-similar, blocked-dissimilar, algorithm-dissimilar, and random-dissimilar. Algorithm practice was a hybrid practice schedule (a combination of blocked, serial, and random practice) that switching between practice schedules were based on error trial number, ≤33%. The sequential motor task was used to record the absolute timing for the absolute timing goals (ATGs). In similar conditions, the participants' performance was near ATGs (1,350, 1,500, 1,650 ms) and in dissimilar conditions, they performed far ATGs (1,050, 1,500, 1,950 ms) with the same spatial sequence for all groups. EEG signals were continuously collected during the acquisition phase and delayed retention. Data were analyzed in different bands (alpha and beta) and scalp locations (frontal: Fp1, Fp2, F3, F4; central: C3, C4; and parietal: P3, P4) with repeated measures on the last factor. The analyses were included motor preparation and intertrial interval (motor evaluation) periods in the first six blocks and the last six blocks, respectively. The results of behavioral data indicated that algorithm practice resulted in medium error related to classic blocked and random practice during the acquisition, however, algorithm practice outperformed the classic blocked and random practice in the delayed retention test. The results of EEG data demonstrated that algorithm practice, due to optimal activity in the frontal lobe (medium alpha and beta activation at prefrontal), resulted in increased activity of sensorimotor areas (high alpha activation at C3 and P4) in older adults. Also, EEG data showed that similar conditions could affect the intertrial interval period (medium alpha and beta activation in frontal in the last six-block), while the dissimilar conditions could affect the motor preparation period (medium alpha and beta activation in frontal in the first six-block). In conclusion, algorithm practice can enhance motor learning and optimize the efficiency of brain activity, resulting in the achievement of a desirable goal in older adults.",2020,"The results of behavioral data indicated that algorithm practice resulted in medium error related to classic blocked and random practice during the acquisition, however, algorithm practice outperformed the classic blocked and random practice in the delayed retention test.","['Sixty older adults (mean age, 67.68 ± 3.95 years', 'Older Adults', 'older adults']","['blocked-similar, algorithm-similar, random-similar, blocked-dissimilar, algorithm-dissimilar, and random-dissimilar']","['motor preparation period (medium alpha and beta activation', 'intertrial interval period (medium alpha and beta activation', 'bands (alpha and beta) and scalp locations (frontal', 'activity of sensorimotor areas (high alpha activation at C3 and P4', 'motor preparation and intertrial interval (motor evaluation) periods']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0443202', 'cui_str': 'Dissimilar'}]","[{'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0330390', 'cui_str': 'Beta'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0175723', 'cui_str': 'Band'}, {'cui': 'C0036270', 'cui_str': 'Scalp structure'}, {'cui': 'C0450429', 'cui_str': 'Location'}, {'cui': 'C0205123', 'cui_str': 'Coronal'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C3499125', 'cui_str': 'Sensory Motor Cortex'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}]",60.0,0.0202841,"The results of behavioral data indicated that algorithm practice resulted in medium error related to classic blocked and random practice during the acquisition, however, algorithm practice outperformed the classic blocked and random practice in the delayed retention test.","[{'ForeName': 'Meysam', 'Initials': 'M', 'LastName': 'Beik', 'Affiliation': 'Motor Behavior Laboratory, Department of Motor Behavior, Faculty of Sport Sciences, Ferdowsi University of Mashhad, Mashhad, Iran.'}, {'ForeName': 'Hamidreza', 'Initials': 'H', 'LastName': 'Taheri', 'Affiliation': 'Motor Behavior Laboratory, Department of Motor Behavior, Faculty of Sport Sciences, Ferdowsi University of Mashhad, Mashhad, Iran.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Saberi Kakhki', 'Affiliation': 'Motor Behavior Laboratory, Department of Motor Behavior, Faculty of Sport Sciences, Ferdowsi University of Mashhad, Mashhad, Iran.'}, {'ForeName': 'Majid', 'Initials': 'M', 'LastName': 'Ghoshuni', 'Affiliation': 'Department of Biomedical Engineering, Islamic Azad University, Mashhad Branch, Mashhad, Iran.'}]",Frontiers in aging neuroscience,['10.3389/fnagi.2020.00173'] 2160,32595518,The Effects of Concurrent Training Combining Both Resistance Exercise and High-Intensity Interval Training or Moderate-Intensity Continuous Training on Metabolic Syndrome.,"To date, there are several knowledge gaps on how to properly prescribe concurrent training to achieve the best dose-response, especially regarding the optimal intensity or volume of the aerobic component. Thus, the objective of this study is to analyze the effects of different aerobic exercise modes and intensities [i.e. aerobic high-intensity interval training (HIIT) versus moderate-intensity continuous aerobic training (MICT) combined with a resistance training (RT) program] on metabolic outcomes in participants with metabolic syndrome (MetS). Thirty-nine men and women (67.0 ± 6.7 years) volunteered to a 12-weeks exercise intervention (3 week -1 , 50 min/session) and were randomly assigned to one of three groups: (a) RT plus MICT (RT+MICT) (2 males; 11 females); (b) RT plus HIIT (RT+HIIT) (4 males; 9 females); and (c) control group (CON) - without formal exercise (4 males; 9 females). Intensity was established between 60 and 70% of maximum heart rate (HRmax) in RT+MICT and ranged from 55-65% to 80-90% HRmax in the RT+HIIT group. Dependent outcomes included morphological, metabolic and hemodynamic variables. Both training groups improved waist circumference (RT+MICT: P = 0.019; RT+HIIT: P = 0.003), but not body weight, fat mass or fat-free mass ( P ≥ 0.114). RT+HIIT group improved fasting glucose ( P = 0.014), low density lipoprotein [LDL ( P = 0.022)], insulin ( P = 0.034) and homeostatic model assessment ( P = 0.028). RT+MICT group reduced triglycerides ( P = 0.053). Both exercise interventions did not change high sensitivity C-reactive protein, glycated hemoglobin, high density lipoprotein and total cholesterol, systolic, diastolic or mean arterial blood pressure ( P ≥ 0.05). The CON group reduced the LDL ( P = 0.031). This trial suggests that short-term exercise mode and intensity may differently impact the metabolic profile of individuals with MetS. Further, our data suggests that both concurrent trainings promote important cardiometabolic gains, particularly in the RT+HIIT. Nonetheless, due to the small-to-moderate effect size and the short-term intervention length, our data suggests that the intervention length also has an important modulating role in these benefits in older adults with MetS. Therefore, more research is needed to confirm our results using longer exercise interventions and larger groups.",2020,"Both exercise interventions did not change high sensitivity C-reactive protein, glycated hemoglobin, high density lipoprotein and total cholesterol, systolic, diastolic or mean arterial blood pressure ( P ≥ 0.05).","['4 males; 9 females', 'Metabolic Syndrome', 'Thirty-nine men and women (67.0 ± 6.7 years) volunteered to a 12-weeks', 'participants with metabolic syndrome (MetS', 'older adults with MetS']","['RT plus MICT (RT+MICT', 'RT plus HIIT', 'exercise intervention', 'Concurrent Training Combining Both Resistance Exercise and High-Intensity Interval Training or Moderate-Intensity Continuous Training', 'control group (CON) - without formal exercise', 'aerobic exercise modes and intensities [i.e. aerobic high-intensity interval training (HIIT) versus moderate-intensity continuous aerobic training (MICT) combined with a resistance training (RT) program', 'CON']","['triglycerides', 'waist circumference', 'fasting glucose', 'homeostatic model assessment', 'low density lipoprotein [LDL', 'sensitivity C-reactive protein, glycated hemoglobin, high density lipoprotein and total cholesterol, systolic, diastolic or mean arterial blood pressure', 'body weight, fat mass or fat-free mass', 'LDL', 'maximum heart rate (HRmax', 'metabolic outcomes', 'morphological, metabolic and hemodynamic variables']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C3816447', 'cui_str': '39'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0023823', 'cui_str': 'Low density lipoprotein'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0424679', 'cui_str': 'Fat-free mass'}, {'cui': 'C0744679', 'cui_str': 'Maximum heart rate'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0543482', 'cui_str': 'morphology'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0439828', 'cui_str': 'Variable'}]",,0.0174294,"Both exercise interventions did not change high sensitivity C-reactive protein, glycated hemoglobin, high density lipoprotein and total cholesterol, systolic, diastolic or mean arterial blood pressure ( P ≥ 0.05).","[{'ForeName': 'Marco Antônio R', 'Initials': 'MAR', 'LastName': 'Da Silva', 'Affiliation': 'Faculty of Sport Sciences and Physical Education, University of Coimbra, Coimbra, Portugal.'}, {'ForeName': 'Liliana C', 'Initials': 'LC', 'LastName': 'Baptista', 'Affiliation': 'Department of Medicine, The University of Alabama at Birmingham, Birmingham, AL, United States.'}, {'ForeName': 'Rafael S', 'Initials': 'RS', 'LastName': 'Neves', 'Affiliation': 'Faculty of Sport Sciences and Physical Education, University of Coimbra, Coimbra, Portugal.'}, {'ForeName': 'Elias', 'Initials': 'E', 'LastName': 'De França', 'Affiliation': 'Human Movement Laboratory, São Judas Tadeu University, São Paulo, Brazil.'}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Loureiro', 'Affiliation': 'Faculty of Sport Sciences and Physical Education, University of Coimbra, Coimbra, Portugal.'}, {'ForeName': 'Fabio Santos', 'Initials': 'FS', 'LastName': 'Lira', 'Affiliation': 'Exercise and Immunometabolism Research Group, Department of Physical Education, Universidade Estadual Paulista (UNESP), Presidente Prudente, Brazil.'}, {'ForeName': 'Erico C', 'Initials': 'EC', 'LastName': 'Caperuto', 'Affiliation': 'Human Movement Laboratory, São Judas Tadeu University, São Paulo, Brazil.'}, {'ForeName': 'Manuel T', 'Initials': 'MT', 'LastName': 'Veríssimo', 'Affiliation': 'Faculty of Sport Sciences and Physical Education, University of Coimbra, Coimbra, Portugal.'}, {'ForeName': 'Raul A', 'Initials': 'RA', 'LastName': 'Martins', 'Affiliation': 'Faculty of Sport Sciences and Physical Education, University of Coimbra, Coimbra, Portugal.'}]",Frontiers in physiology,['10.3389/fphys.2020.00572'] 2161,32595523,Oral Contraceptive Use Influences On-Kinetic Adaptations to Sprint Interval Training in Recreationally-Active Women.,"Introduction Oral contraceptive (OC) use influences peak exercise responses to training, however, the influence of OC on central and peripheral adaptations to exercise training are unknown. This study investigated the influence of OC use on changes in time-to-fatigue, pulmonary oxygen uptake, cardiac output, and heart rate on-kinetics, as well as tissue saturation index to 4 weeks of sprint interval training in recreationally active women. Methods Women taking an oral contraceptive (OC; n = 25) or experiencing natural menstrual cycles (MC; n = 22) completed an incremental exercise test to volitional exhaustion followed by a square-wave step-transition protocol to moderate (90% of power output at ventilatory threshold) and high intensity (Δ50% of power output at ventilatory threshold) exercise on two separate occasions. Time-to-fatigue, pulmonary oxygen uptake on-kinetics, cardiac output, and heart rate on-kinetics, and tissue saturation index responses were assessed prior to, and following 12 sessions of sprint interval training (10 min × 1 min efforts at 100-120% PPO in a 1:2 work:rest ratio) completed over 4 weeks. Results Time-to-fatigue increased in both groups following training ( p < 0.001), with no difference between groups. All cardiovascular on-kinetic parameters improved to the same extent following training in both groups. Greater improvements in pulmonary oxygen up-take kinetics were seen at both intensities in the MC group ( p < 0.05 from pre-training) but were blunted in the OC group ( p > 0.05 from pre-training). In contrast, changes in tissue saturation index were greater in the OC group at both intensities ( p < 0.05); with the MC group showing no changes at either intensity. Discussion Oral contraceptive use may reduce central adaptations to sprint interval training in women without influencing improvements in exercise performance - potentially due to greater peripheral adaptation. This may be due to the influence of exogenous oestradiol and progestogen on cardiovascular function and skeletal muscle blood flow. Further investigation into female-specific influences on training adaptation and exercise performance is warranted.",2020,"In contrast, changes in tissue saturation index were greater in the OC group at both intensities ( p < 0.05); with the MC group showing no changes at either intensity. ","['recreationally active women', 'Methods\n\n\nWomen taking an oral contraceptive (OC; n = 25) or experiencing natural menstrual cycles (MC; n = 22) completed an', 'Recreationally-Active Women']","['Introduction\n\n\nOral contraceptive (OC', 'Sprint Interval Training', 'exogenous oestradiol and progestogen', 'sprint interval training', 'incremental exercise test to volitional exhaustion followed by a square-wave step-transition protocol to moderate (90% of power output at ventilatory threshold) and high intensity (Δ50% of power output at ventilatory threshold) exercise']","['time-to-fatigue, pulmonary oxygen uptake, cardiac output, and heart rate on-kinetics, as well as tissue saturation index', 'Results\n\n\nTime-to-fatigue', 'Time-to-fatigue, pulmonary oxygen uptake on-kinetics, cardiac output, and heart rate on-kinetics, and tissue saturation index responses', 'pulmonary oxygen up-take kinetics', 'cardiovascular function and skeletal muscle blood flow', 'tissue saturation index']","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0205296', 'cui_str': 'Natural'}, {'cui': 'C0025329', 'cui_str': 'Normal menstrual cycle'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}, {'cui': 'C4279979', 'cui_str': 'Sprint Interval Training'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0014912', 'cui_str': 'Estradiol'}, {'cui': 'C0033306', 'cui_str': 'Progestational hormone'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}, {'cui': 'C0392674', 'cui_str': 'Exhaustion'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0205120', 'cui_str': 'Square'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0445194', 'cui_str': 'Power output'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}, {'cui': 'C0007165', 'cui_str': 'Cardiac output'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0022702', 'cui_str': 'Kinetics'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0522534', 'cui_str': 'Saturated'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0007227', 'cui_str': 'Cardiovascular function'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}]",,0.0268788,"In contrast, changes in tissue saturation index were greater in the OC group at both intensities ( p < 0.05); with the MC group showing no changes at either intensity. ","[{'ForeName': 'Mia Annalies', 'Initials': 'MA', 'LastName': 'Schaumberg', 'Affiliation': 'School of Health and Sport Sciences, University of the Sunshine Coast, Sippy Downs, QLD, Australia.'}, {'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Stanley', 'Affiliation': 'South Australian Sports Institute, Kidman Park, SA, Australia.'}, {'ForeName': 'David G', 'Initials': 'DG', 'LastName': 'Jenkins', 'Affiliation': 'School of Health and Sport Sciences, University of the Sunshine Coast, Sippy Downs, QLD, Australia.'}, {'ForeName': 'Emily A', 'Initials': 'EA', 'LastName': 'Hume', 'Affiliation': 'School of Clinical Medicine, The University of Queensland, Brisbane, QLD, Australia.'}, {'ForeName': 'Xanne A K', 'Initials': 'XAK', 'LastName': 'Janse de Jonge', 'Affiliation': 'School of Environmental and Life Sciences, The University of Newcastle, Ourimbah, NSW, Australia.'}, {'ForeName': 'Lynne M', 'Initials': 'LM', 'LastName': 'Emmerton', 'Affiliation': 'School of Pharmacy and Biomedical Sciences, Curtin University, Perth, WA, Australia.'}, {'ForeName': 'Tina L', 'Initials': 'TL', 'LastName': 'Skinner', 'Affiliation': 'School of Human Movement and Nutrition Sciences, The University of Queensland, Brisbane, QLD, Australia.'}]",Frontiers in physiology,['10.3389/fphys.2020.00629'] 2162,32595542,Change in the Neural Response to Auditory Deviance Following Cognitive Therapy for Hallucinations in Patients With Schizophrenia.,"Adjunctive psychotherapeutic approaches recommended for patients with schizophrenia (SZ) who are fully or partially resistant to pharmacotherapy have rarely utilized biomarkers to enhance the understanding of treatment-effective mechanisms. As SZ patients with persistent auditory verbal hallucinations (AVH) frequently evidence reduced neural responsiveness to external auditory stimulation, which may impact cognitive and functional outcomes, this study examined the effects of cognitive behavioral therapy for voices (CBTv) on clinical and AVH symptoms and the sensory processing of auditory deviants as measured with the electroencephalographically derived mismatch negativity (MMN) response. Twenty-four patients with SZ and AVH were randomly assigned to group CBTv treatment or a treatment as usual (TAU) condition. Patients in the group CBTv condition received treatment for 5 months while the matched control patients received TAU for the same period, followed by 5 months of group CBTv. Assessments were conducted at baseline and at the end of treatment. Although not showing consistent changes in the frequency of AVHs, CBTv (vs. TAU) improved patients' appraisal (p = 0.001) of and behavioral/emotional responses to AVHs, and increased both MMN generation (p = 0.001) and auditory cortex current density (p = 0.002) in response to tone pitch deviants. Improvements in AVH symptoms were correlated with change in pitch deviant MMN and current density in left primary auditory cortex. These findings of improved auditory information processing and symptom-response attributable to CBTv suggest potential clinical and functional benefits of psychotherapeutical approaches for patients with persistent AVHs.",2020,Improvements in AVH symptoms were correlated with change in pitch deviant MMN and current density in left primary auditory cortex.,"['patients with schizophrenia (SZ', 'patients with persistent auditory verbal hallucinations (AVH', 'Patients With Schizophrenia', 'patients with persistent AVHs', 'Twenty-four patients with SZ and AVH']","['TAU', 'Cognitive Therapy', 'cognitive behavioral therapy', 'SZ']","['AVH symptoms', 'MMN generation', 'Neural Response to Auditory Deviance', 'frequency of AVHs, CBTv (vs. TAU', 'auditory cortex current density']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C2721589', 'cui_str': 'Verbal hallucinations'}, {'cui': 'C3715070', 'cui_str': '24'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}]","[{'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C2721589', 'cui_str': 'Verbal hallucinations'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0004302', 'cui_str': 'Auditory area of cortex'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0178587', 'cui_str': 'Density'}]",24.0,0.0429154,Improvements in AVH symptoms were correlated with change in pitch deviant MMN and current density in left primary auditory cortex.,"[{'ForeName': 'Verner', 'Initials': 'V', 'LastName': 'Knott', 'Affiliation': 'School of Psychology, University of Ottawa, Ottawa, ON, Canada.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Wright', 'Affiliation': 'Schizophrenia Program, The Royal Ottawa Mental Health Centre, Ottawa, ON, Canada.'}, {'ForeName': 'Dhrasti', 'Initials': 'D', 'LastName': 'Shah', 'Affiliation': 'School of Psychology, University of Ottawa, Ottawa, ON, Canada.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Baddeley', 'Affiliation': 'Clinical Neuroelectrophysiology and Cognitive Research Laboratory, University of Ottawa Institute of Mental Health Research, Ottawa, ON, Canada.'}, {'ForeName': 'Hayley', 'Initials': 'H', 'LastName': 'Bowers', 'Affiliation': 'Schizophrenia Program, The Royal Ottawa Mental Health Centre, Ottawa, ON, Canada.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'de la Salle', 'Affiliation': 'School of Psychology, University of Ottawa, Ottawa, ON, Canada.'}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Labelle', 'Affiliation': 'Department of Psychiatry, University of Ottawa, Ottawa, ON, Canada.'}]",Frontiers in psychiatry,['10.3389/fpsyt.2020.00555'] 2163,32595553,"Well Done! Effects of Positive Feedback on Perceived Self-Efficacy, Flow and Performance in a Mental Arithmetic Task.","Self-efficacy is a well-known psychological resource, being positively associated with increased performance. Furthermore, results from field studies suggest a positive impact of self-efficacy on flow experience, which has not yet been tested experimentally. In this study, we manipulated self-efficacy by means of positive feedback and investigated whether self-efficacy serves as a mediator in the relationship between positive feedback and flow and in the relationship between positive feedback and performance. Our sample consisted of 102 participants (63 female, 39 male). The experimental group received positive feedback after completing 5 min of mental arithmetic tasks on a computer, whereas the control group received no feedback. A second session of a mental arithmetic task was then completed for 5 min. Mediation analyses confirmed that specific self-efficacy mediated a positive effect of positive feedback on flow as well as on both performance measures (quality and quantity) in a subsequent task. However, direct effects of feedback on flow and on performance were not significant, which suggests the presence of other mechanisms that remain to be investigated.",2020,Mediation analyses confirmed that specific self-efficacy mediated a positive effect of positive feedback on flow as well as on both performance measures (quality and quantity) in a subsequent task.,"['102 participants (63 female, 39 male']","['positive feedback after completing 5 min of mental arithmetic tasks on a computer, whereas the control group received no feedback', 'Positive Feedback']","['Perceived Self-Efficacy, Flow and Performance in a Mental Arithmetic Task', 'Self-efficacy']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}]",102.0,0.0851609,Mediation analyses confirmed that specific self-efficacy mediated a positive effect of positive feedback on flow as well as on both performance measures (quality and quantity) in a subsequent task.,"[{'ForeName': 'Corinna', 'Initials': 'C', 'LastName': 'Peifer', 'Affiliation': 'Faculty of Psychology, Applied Psychology in Work, Health, and Development, Ruhr University Bochum, Bochum, Germany.'}, {'ForeName': 'Pia', 'Initials': 'P', 'LastName': 'Schönfeld', 'Affiliation': 'Faculty of Psychology, Mental Health Research and Treatment Center, Ruhr University Bochum, Bochum, Germany.'}, {'ForeName': 'Gina', 'Initials': 'G', 'LastName': 'Wolters', 'Affiliation': 'Faculty of Psychology, Applied Psychology in Work, Health, and Development, Ruhr University Bochum, Bochum, Germany.'}, {'ForeName': 'Fabienne', 'Initials': 'F', 'LastName': 'Aust', 'Affiliation': 'Faculty of Psychology, Applied Psychology in Work, Health, and Development, Ruhr University Bochum, Bochum, Germany.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Margraf', 'Affiliation': 'Faculty of Psychology, Mental Health Research and Treatment Center, Ruhr University Bochum, Bochum, Germany.'}]",Frontiers in psychology,['10.3389/fpsyg.2020.01008'] 2164,32595557,Effects on Personal Factors Through Flipped Learning and Gamification as Combined Methodologies in Secondary Education.,"Purpose This study aims to analyze the effects of a flipped and gamified program on the autonomy, competence, relation with others, satisfaction/enjoyment, intrinsic and extrinsic motivation, and boredom of students of Physical Education. Method The study used a control group and an experimental group to compare pretest and posttest data in both of them. Instruments used were the Basic Psychological Needs in Exercise Scale, Sport Motivation Scale, and Sport Satisfaction Instrument, all of them validated in academic literature. Results On one hand, data indicated that autonomy has been increased with the application of these teaching methodologies. On the other hand, students' satisfaction, enjoyment, and intrinsic motivation have improved based on the interaction with gamification and flipped learning. Finally, with all dimensions, it seems that academic performance has been improved, although not in a significative way. Discussion/Conclusion Results of the study provide to educational researchers valuable information for a better understanding of how flipped learning and gamification influence personal performance of Physical Education students.",2020,"On the other hand, students' satisfaction, enjoyment, and intrinsic motivation have improved based on the interaction with gamification and flipped learning.",[],['flipped and gamified program'],"['autonomy, competence, relation with others, satisfaction/enjoyment, intrinsic and extrinsic motivation, and boredom of students of Physical Education', 'Basic Psychological Needs in Exercise Scale, Sport Motivation Scale, and Sport Satisfaction Instrument']",[],"[{'cui': 'C0540654', 'cui_str': 'Casper Protein'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0679105', 'cui_str': 'Pleasure'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0392342', 'cui_str': 'Extrinsic motivation'}, {'cui': 'C0006019', 'cui_str': 'Boredom'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0031805', 'cui_str': 'Education, Physical'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0038039', 'cui_str': 'Sport'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}]",,0.0148784,"On the other hand, students' satisfaction, enjoyment, and intrinsic motivation have improved based on the interaction with gamification and flipped learning.","[{'ForeName': 'Adrián', 'Initials': 'A', 'LastName': 'Segura-Robles', 'Affiliation': 'Department of Research Methods and Diagnosis in Education, University of Granada, Granada, Spain.'}, {'ForeName': 'Arturo', 'Initials': 'A', 'LastName': 'Fuentes-Cabrera', 'Affiliation': 'Department of Didactics and School Organization, University of Granada, Granada, Spain.'}, {'ForeName': 'María Elena', 'Initials': 'ME', 'LastName': 'Parra-González', 'Affiliation': 'Department of Research Methods and Diagnosis in Education, University of Granada, Granada, Spain.'}, {'ForeName': 'Jesús', 'Initials': 'J', 'LastName': 'López-Belmonte', 'Affiliation': 'Department of Didactics and School Organization, University of Granada, Granada, Spain.'}]",Frontiers in psychology,['10.3389/fpsyg.2020.01103'] 2165,32595566,Affective Consequences of Social Comparisons by Women With Breast Cancer: An Experiment.,"Objective People with severe illness often meet and compare themselves with other patients. Some of these comparison standards do well, others do poorly. Such comparisons could have positive as well as negative consequences depending on whether people identify or contrast from the standard. In the present study, we examine whether patients with breast cancer can benefit from comparisons by engaging in favorable comparison processes. Design 102 women diagnosed with breast cancer were randomly assigned to read a (fictitious) self-report from a well or poorly adjusted breast cancer patient. Main Outcome Measures Participants reported their affective reaction (mood, anxiety, depression) and specified their comparison process (identification or contrast). Results In general, participants engaged in favorable comparison processes by contrasting predominantly with poorly adjusted patients, and identifying with well-adjusted ones. Participants’ Mood Assimilated to the Standard Participants reported more positive mood after having been exposed to the well-adjusted than the poorly adjusted standard. Anxiety and Depression Varied With the Type of Comparison Process It was lower the more they avoided unfavorable comparisons (contrasting with the well-adjusted patient and identifying with the poorly adjusted one). Conclusion Patients adjust their comparison processes to the standard to experience favorable comparisons. Especially avoiding unfavorable comparison processes reduces the risk of negative consequences after encountering other patients. Thus, patients may profit from comparisons as long as they engage in the right process.",2020,"With the Type of Comparison Process It was lower the more they avoided unfavorable comparisons (contrasting with the well-adjusted patient and identifying with the poorly adjusted one). ","['102 women diagnosed with breast cancer', 'Women With Breast Cancer', 'patients with breast cancer']",['read a (fictitious) self-report from a well or poorly adjusted breast cancer patient'],"['affective reaction (mood, anxiety, depression) and specified their comparison process (identification or contrast', 'positive mood', 'Anxiety and Depression Varied']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0205169', 'cui_str': 'Bad'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0020792', 'cui_str': 'Identification - mental defense mechanism'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C1446409', 'cui_str': 'Positive'}]",102.0,0.0427728,"With the Type of Comparison Process It was lower the more they avoided unfavorable comparisons (contrasting with the well-adjusted patient and identifying with the poorly adjusted one). ","[{'ForeName': 'Katja', 'Initials': 'K', 'LastName': 'Corcoran', 'Affiliation': 'Sozialpsychologie, Psychology Institute, Karl-Franzens University of Graz, Graz, Austria.'}, {'ForeName': 'Gayannee', 'Initials': 'G', 'LastName': 'Kedia', 'Affiliation': 'Sozialpsychologie, Psychology Institute, Karl-Franzens University of Graz, Graz, Austria.'}, {'ForeName': 'Rifeta', 'Initials': 'R', 'LastName': 'Illemann', 'Affiliation': 'Sozialpsychologie, Psychology Institute, Karl-Franzens University of Graz, Graz, Austria.'}, {'ForeName': 'Helga', 'Initials': 'H', 'LastName': 'Innerhofer', 'Affiliation': 'Sozialpsychologie, Psychology Institute, Karl-Franzens University of Graz, Graz, Austria.'}]",Frontiers in psychology,['10.3389/fpsyg.2020.01234'] 2166,32595569,Effects of Expressive Arts-Based Interventions on Adults With Intellectual Disabilities: A Stratified Randomized Controlled Trial.,"Background People with intellectual disabilities have difficulties expressing their views and can manifest psychological and behavioral symptoms. The present study aimed to examine the effects of expressive arts-based intervention (EABI) on the behavioral and emotional well-being of adults with intellectual disabilities. Methods This study assigned 109 Chinese adults with intellectual disabilities into EABI ( N = 55) or control groups ( N = 54) using stratified randomization. Pre- and post-intervention quantitative assessments were conducted of aberrant behaviors, personal well-being, mood and color usage in drawings. Focus group interviews were conducted with the EABI participants and their caseworkers at the post-intervention stage. Repeated-measures analysis of covariance evaluated the EABI effects with age, gender and degree of intellectual disability as covariates, and latent profile analysis examined the patterns of color usage in drawings. Qualitative thematic analysis was performed on the interview data. Results The interview findings suggest that the EABI group was more emotionally expressive and stable after the intervention. Compared to the control group, the EABI group tended to use more diverse colors and leave less empty space in their drawings. No significant overall improvements were found in the EABI group with respect to aberrant behaviors, mood or personal well-being. Among males, the EABI participants showed significantly more anger and less energetic moods than those in the control group. Among females, the EABI participants showed significantly lower levels of aberrant behavior than those in the control group. Conclusion The results of this study suggest that expressive arts-based interventions have different effects on the emotional and behavioral well-being of male and female participants. Moreover, increased color usage may imply a more positive state of emotional well-being.",2020,"No significant overall improvements were found in the EABI group with respect to aberrant behaviors, mood or personal well-being.","['109 Chinese adults with intellectual disabilities into EABI ( N = 55) or control groups ( N = 54) using stratified randomization', 'male and female participants', 'adults with intellectual disabilities', 'Adults With Intellectual Disabilities', '\n\n\nPeople with intellectual disabilities']","['expressive arts-based intervention (EABI', 'Expressive Arts-Based Interventions']","['emotionally expressive', 'aberrant behavior', 'energetic moods', 'aberrant behaviors, personal well-being, mood and color usage', 'diverse colors and leave less empty space', 'aberrant behaviors, mood or personal well-being']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C3714756', 'cui_str': 'Intellectual disability'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0443127', 'cui_str': 'Aberrant'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0457083', 'cui_str': 'Usage'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}]",109.0,0.042658,"No significant overall improvements were found in the EABI group with respect to aberrant behaviors, mood or personal well-being.","[{'ForeName': 'Rainbow T H', 'Initials': 'RTH', 'LastName': 'Ho', 'Affiliation': 'Department of Social Work and Social Administration, The University of Hong Kong, Pokfulam, Hong Kong.'}, {'ForeName': 'Caitlin K P', 'Initials': 'CKP', 'LastName': 'Chan', 'Affiliation': 'Centre on Behavioral Health, The University of Hong Kong, Pokfulam, Hong Kong.'}, {'ForeName': 'Ted C T', 'Initials': 'TCT', 'LastName': 'Fong', 'Affiliation': 'Centre on Behavioral Health, The University of Hong Kong, Pokfulam, Hong Kong.'}, {'ForeName': 'Pandora H T', 'Initials': 'PHT', 'LastName': 'Lee', 'Affiliation': 'Centre on Behavioral Health, The University of Hong Kong, Pokfulam, Hong Kong.'}, {'ForeName': 'Derek S Y', 'Initials': 'DSY', 'LastName': 'Lum', 'Affiliation': 'Centre on Behavioral Health, The University of Hong Kong, Pokfulam, Hong Kong.'}, {'ForeName': 'S H', 'Initials': 'SH', 'LastName': 'Suen', 'Affiliation': 'Madam Lo Lee Pui Ching Memorial Workshop, Yan Chai Hospital, Tsuen Wan, Hong Kong.'}]",Frontiers in psychology,['10.3389/fpsyg.2020.01286'] 2167,32595571,Social Competence and Peer Social Acceptance: Evaluating Effects of an Educational Intervention in Adolescents.,"This study aims to evaluate the impact of an educational intervention on social competence and social acceptance among adolescents. The participants were 106 adolescents aged 12-15 years ( M = 13.41 years; SD = 0.81 years). Participants were randomly assigned to the control group ( n = 44) and an experimental group ( n = 69). In the experimental group, an intervention based on the Sport Education Model (SEM) was applied. While in the control group, an intervention based on the Traditional Model of Direct Instruction (TM-DI) was carried out. An experimental design with repeated pretest and posttest measurements was developed. The Adolescent Multidimensional Social Competence Questionnaire (AMSC-Q) was used to assess social competence. The Guess Who (GW4) questionnaire was used to assess social acceptance (SA) among peers. The preliminary results showed that the intervention based on the SEM (experimental group) promoted more significant improvements in some indicators of social competence and social acceptance among peers than those obtained with the TM-DI (control group). The results confirm a similar impact of the intervention between boys and girls. These preliminary results suggest the potential of the Sport Education Model with adolescents.",2020,The preliminary results showed that the intervention based on the SEM (experimental group) promoted more significant improvements in some indicators of social competence and social acceptance among peers than those obtained with the TM-DI (control group).,"['106 adolescents aged 12-15 years ( M = 13.41 years; SD = 0.81 years', 'Adolescents', 'adolescents']","['educational intervention', 'Educational Intervention']","['social acceptance (SA', 'Adolescent Multidimensional Social Competence Questionnaire (AMSC-Q', 'social competence and social acceptance']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0679005', 'cui_str': 'Social Abilities'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",106.0,0.0139848,The preliminary results showed that the intervention based on the SEM (experimental group) promoted more significant improvements in some indicators of social competence and social acceptance among peers than those obtained with the TM-DI (control group).,"[{'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Luna', 'Affiliation': 'Department of Psychology, Faculty of Education, University of Castilla-La Mancha, Ciudad Real, Spain.'}, {'ForeName': 'Jerónimo', 'Initials': 'J', 'LastName': 'Guerrero', 'Affiliation': 'Department of Physical Education, Instituto de Enseñanza Secundaria (IES) Lazarillo de Tormes, Toledo, Spain.'}, {'ForeName': 'Débora', 'Initials': 'D', 'LastName': 'Rodrigo-Ruiz', 'Affiliation': 'Department of Research and Diagnostic Methods in Education II, Faculty of Education, International University of La Rioja (UNIR), Logroño, Spain.'}, {'ForeName': 'Lidia', 'Initials': 'L', 'LastName': 'Losada', 'Affiliation': 'Faculty of Education, National University of Distance Education (UNED), Madrid, Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Cejudo', 'Affiliation': 'Department of Psychology, Faculty of Education, University of Castilla-La Mancha, Ciudad Real, Spain.'}]",Frontiers in psychology,['10.3389/fpsyg.2020.01305'] 2168,32595745,"Efficacy and Safety of Tongning Gel for Knee Osteoarthritis: A Multicentre, Randomized, Double-Blinded, Parallel, Placebo-Controlled, Clinical Trial.","Objective To evaluate the efficacy and safety of Tongning Gel (TNG) compared to placebo-controlled (PC) for knee osteoarthritis (KOA). Methods A multicentre, randomized, double-blinded, parallel, placebo-controlled, clinical trial was performed in 576 patients (432 patients in the TNG group, 144 patients in the PC group), and 1 in the experimental group withdrew due to nonuse of drug. Patients were randomized to receive TNG or PC applied to knee skin at 3g per time, 2 times per day, which lasted for 3 weeks. The Western Ontario and McMaster Universities Arthritis Index (WOMAC) pain score was used to evaluate the primary efficacy of TNG and WOMAC stiffness and physical function and total scores were used to evaluate the secondary efficacy of TNG. All participants who received at least one dose of study drug were included in the safety analysis. This trial has been registered in Chinese Clinical Trial Registry (no. CTR20131276). Results Primary efficiency outcome: there were significant differences in the decreased value of WOMAC pain score between two groups ( P < 0.05), and the decreased value of WOMAC pain score in the TNG group were better than those in the PC group ( P < 0.05). Secondary efficiency outcome: the WOMAC total score, WOMAC stiffness score, WOMAC physical function score, and the decrease of the above indexes of the two groups of patients after treatment were statistically significant ( P < 0.05), and the improvement of the above indexes in the TNG group was better than that of the PC group ( P < 0.05). Safety Evaluation . A total of 42 adverse events were reported by 29 patients: 25 adverse events reported by 16 patients (3.71%) in the experimental group and 17 adverse events were reported by 13 patients (9.03%) in the control group. And 8 adverse reactions were reported by 6 patients including 2 adverse reactions by 2 patients (0.46%) in the experimental group and 6 adverse reactions by 4 patients (2.78%) in the control group. Two cases of significant adverse events occurred in the experimental group. Both groups had one serious adverse event, respectively, which were not relevant to the intervention. Conclusion These results of the trial demonstrate that TNG is superior to placebo in the treatment of patients with KOA, and TNG can improve other symptoms of KOA, such as stiffness and physical function. TNG is safe for the treatment of knee osteoarthritis as a whole.",2020,A total of 42 adverse events were reported by 29 patients: 25 adverse events reported by 16 patients (3.71%) in the experimental group and 17 adverse events were reported by 13 patients (9.03%) in the control group.,"['All participants who received at least one dose of study drug were included in the safety analysis', '576 patients (432 patients in the TNG group, 144 patients in the PC group), and 1 in the experimental group withdrew due to nonuse of drug', 'knee osteoarthritis (KOA', 'Knee Osteoarthritis']","['Placebo', 'TNG or PC', 'placebo-controlled (PC', 'Tongning Gel', 'Tongning Gel (TNG', 'TNG', 'placebo']","['Efficacy and Safety', 'TNG and WOMAC stiffness and physical function and total scores', 'WOMAC total score, WOMAC stiffness score, WOMAC physical function score, and the decrease of the above indexes', 'efficacy and safety', 'adverse events', 'Western Ontario and McMaster Universities Arthritis Index (WOMAC) pain score', 'adverse reactions', 'improvement of the above indexes', 'WOMAC pain score']","[{'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0013175', 'cui_str': 'Clinical drug trial'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4760627', 'cui_str': '144'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0424092', 'cui_str': 'Withdrawn'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0003864', 'cui_str': 'Arthritis'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}]",576.0,0.111007,A total of 42 adverse events were reported by 29 patients: 25 adverse events reported by 16 patients (3.71%) in the experimental group and 17 adverse events were reported by 13 patients (9.03%) in the control group.,"[{'ForeName': 'Ye', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai 201203, China.'}, {'ForeName': 'Zhi Bi', 'Initials': 'ZB', 'LastName': 'Shen', 'Affiliation': 'Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai 201203, China.'}, {'ForeName': 'Ji Rong', 'Initials': 'JR', 'LastName': 'Ge', 'Affiliation': 'Fujian Institute of Traditional Chinese Medicines, Fuzhou 350003, China.'}, {'ForeName': 'Wen Gang', 'Initials': 'WG', 'LastName': 'Liu', 'Affiliation': 'Guangdong No. 2 Hospital of Traditional Chinese Medicine, Guangzhou 510095, China.'}, {'ForeName': 'Jun Xing', 'Initials': 'JX', 'LastName': 'Yang', 'Affiliation': 'No. 1 Hospital Affiliated to Guangzhou University of Traditional Chinese Medicine, Guangzhou 510405, China.'}, {'ForeName': 'Cheng Jian', 'Initials': 'CJ', 'LastName': 'He', 'Affiliation': 'Hubei Hospital of Traditional Chinese Medicine, Wuhan 430061, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Lu', 'Affiliation': 'No. 1 Hospital Affiliated to Hunan University of Traditional Chinese Medicine, Changsha 410021, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Shen', 'Affiliation': 'Union Hospital Affiliated to Tongji Medical College, Huazhong University of Science and Technology, Wuhan 430022, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Yin', 'Affiliation': 'Nanjing Hospital of Traditional Chinese Medicine, Nanjing 210022, China.'}, {'ForeName': 'Yong Qiang', 'Initials': 'YQ', 'LastName': 'Chen', 'Affiliation': 'Shanghai Hospital of Traditional Chinese Medicine, Shanghai 200071, China.'}, {'ForeName': 'Zhi Bin', 'Initials': 'ZB', 'LastName': 'Li', 'Affiliation': 'Hospital Affiliated to Shanxi University of Traditional Chinese Medicine, Xianyang 712000, China.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Sun', 'Affiliation': 'No. 1 Hospital Affiliated to Tianjin University of Traditional Chinese Medicine, Tianjin 300193, China.'}, {'ForeName': 'Li Ming', 'Initials': 'LM', 'LastName': 'Xie', 'Affiliation': ""Guang'anmen Hospital Affiliated to the China Academy of Traditional Chinese Medical Sciences, Beijing 100053, China.""}, {'ForeName': 'Wei An', 'Initials': 'WA', 'LastName': 'Yuan', 'Affiliation': 'Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai 201203, China.'}, {'ForeName': 'Yu Xin', 'Initials': 'YX', 'LastName': 'Zheng', 'Affiliation': 'Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai 201203, China.'}, {'ForeName': 'Hong Sheng', 'Initials': 'HS', 'LastName': 'Zhan', 'Affiliation': 'Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai 201203, China.'}]",Evidence-based complementary and alternative medicine : eCAM,['10.1155/2020/8707256'] 2169,32595749,Effect of Transcutaneous Electrical Acupoint Stimulation on One-Lung Ventilation-Induced Lung Injury in Patients Undergoing Esophageal Cancer Operation.,"Objective To investigate the effect of transcutaneous electrical acupoint stimulation (TEAS) on one-lung ventilation-induced injury in patients undergoing esophageal cancer operation. Methods The participants ( n  = 121) were randomly assigned into TEAS and sham groups. The TEAS group was given transcutaneous electrical stimulation therapy. The acupoints selected were Feishu (BL13), Hegu (L14), and Zusanli (ST36) and were treated 30 minutes before induction of anesthesia; treatment lasts 30 minutes. The sham group was connected to the electrode on the same acupoints, but electronic stimulation was not applied. The levels of oxygenation index (PaO 2 /FiO 2 ) and alveolar-arterial oxygen tension difference (A-aDO 2 ) before one-lung ventilation (T1), 30 minutes after one-lung ventilation (T2), 2 hours after one-lung ventilation (T3), and 1 hour after the operation (T4) and the levels of serum tumor necrosis factor- α (TNF- α ), interleukin-6 (IL-6), and interleukin-10 (IL-10) at T1, T2, T3, and 24 hours after the operation (T5) were taken as the primary endpoints. The incidence of postoperative pulmonary complications, removal time of thoracic drainage tube, and length of hospital stay were taken as the secondary endpoints. Results Compared with that, in the sham group, the level of PaO 2 /FiO 2 in the TEAS group was significantly increased at T2, T3, and T4, and the level of A-aDO 2 was significantly reduced at T2 and T3 ( P < 0.05). Besides, compared with that, in the sham group, the level of serum TNF- α at T2, T3, and T5, as well as the level of serum IL-6 at T3 and T5, was significantly reduced, whereas the level of serum IL-10 at T3 was significantly increased ( P < 0.05). The incidences of pulmonary infection and pleural effusion in the TEAS group were significantly lower than that in the sham group, and the removal time of thoracic drainage tube and the length of hospital stay in the TEAS group were significantly shorter than that in the sham group ( P < 0.05). Conclusions TEAS could effectively increase the levels of PaO 2 /FiO 2 and IL-10, reduce the levels of A-aDO 2 , TNF- α , and IL-6, and reduce the incidence of pulmonary complications. Moreover, it could also contribute to shorten the removal time of thoracic drainage tube and the length of hospital stay.",2020,"The incidences of pulmonary infection and pleural effusion in the TEAS group were significantly lower than that in the sham group, and the removal time of thoracic drainage tube and the length of hospital stay in the TEAS group were significantly shorter than that in the sham group ( P < 0.05). ","['Patients Undergoing Esophageal Cancer Operation', 'participants ( n \u2009=\u2009121', 'patients undergoing esophageal cancer operation']","['TEAS', 'Transcutaneous Electrical Acupoint Stimulation', 'transcutaneous electrical stimulation therapy', 'transcutaneous electrical acupoint stimulation (TEAS']","['removal time of thoracic drainage tube and the length of hospital stay', 'postoperative pulmonary complications, removal time of thoracic drainage tube, and length of hospital stay', 'level of serum IL-6', 'incidences of pulmonary infection and pleural effusion', 'levels of serum tumor necrosis factor- α (TNF- α ), interleukin-6 (IL-6), and interleukin-10 (IL-10) at T1, T2, T3, and 24 hours after the operation (T5', 'level of PaO 2 /FiO 2', 'level of serum IL-10 at T3', 'levels of oxygenation index (PaO 2 /FiO 2 ) and alveolar-arterial oxygen tension difference', 'levels of A-aDO 2 , TNF- α , and IL-6, and reduce the incidence of pulmonary complications', 'level of serum TNF- α', 'Feishu (BL13), Hegu (L14), and Zusanli (ST36', 'level of A-aDO 2']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0014859', 'cui_str': 'Neoplasm of esophagus'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0013790', 'cui_str': 'Electricity'}, {'cui': 'C0001302', 'cui_str': 'Acupuncture point'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0040654', 'cui_str': 'Percutaneous electrical nerve stimulation'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0729233', 'cui_str': 'Dissecting aortic aneurysm, thoracic'}, {'cui': 'C0184114', 'cui_str': 'Tube drain'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0876973', 'cui_str': 'Infectious disease of lung'}, {'cui': 'C0032227', 'cui_str': 'Pleural effusion'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0232555', 'cui_str': 'Peak gastric acid output'}, {'cui': 'C1278185', 'cui_str': 'Oxygenation index measurement'}, {'cui': 'C0429685', 'cui_str': 'Alveolar-arterial oxygen tension difference'}, {'cui': 'C0001443', 'cui_str': 'Adenosine'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0450533', 'cui_str': 'ST36'}]",121.0,0.047029,"The incidences of pulmonary infection and pleural effusion in the TEAS group were significantly lower than that in the sham group, and the removal time of thoracic drainage tube and the length of hospital stay in the TEAS group were significantly shorter than that in the sham group ( P < 0.05). ","[{'ForeName': 'Fangchao', 'Initials': 'F', 'LastName': 'Zhao', 'Affiliation': ""Department of Thoracic Surgery, Tangshan People's Hospital, North China University of Science and Technology, Tangshan 063000, China.""}, {'ForeName': 'Zengying', 'Initials': 'Z', 'LastName': 'Wang', 'Affiliation': 'Department of Clinical Medicine, North China University of Science and Technology, Tangshan 063000, China.'}, {'ForeName': 'Chengyuan', 'Initials': 'C', 'LastName': 'Ye', 'Affiliation': ""Department of Cancer Comprehensive Therapy, Tangshan People's Hospital, North China University of Science and Technology, Tangshan 063000, China.""}, {'ForeName': 'Jianming', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': ""Department of Thoracic Surgery, Tangshan People's Hospital, North China University of Science and Technology, Tangshan 063000, China.""}]",Evidence-based complementary and alternative medicine : eCAM,['10.1155/2020/9018701'] 2170,32595770,Efficacy and Safety Evaluation of Human Growth Hormone Therapy in Patients with Idiopathic Short Stature in Korea - A Randomised Controlled Trial.,"BACKGROUND This trial evaluated the efficacy and safety of growth hormone (GH) therapy (Norditropin®; Novo Nordisk, Bagsværd, Denmark) in paediatric patients with idiopathic short stature (ISS) in Korea. METHODS This was an open-label, parallel-group, multicentre, interventional trial (ClinicalTrials.gov identifier: NCT01778023). Pre-pubertal patients (mean age 6.2 years; height, 107.1 cm) were randomised 2:1 to 12 months' GH treatment (0.469 mg/kg/week; group A, n=36) or 6 months untreated followed by 6 months' GH treatment (group B, n=18). Safety analysis was based on adverse events (AEs) in all GH-treated patients. RESULTS After 6 months, height velocity (Ht-V), change in both height standard deviation score (Ht-SDS) and insulin-like growth factor 1 (mean difference [95% confidence interval {CI}]: 5.15 cm/year [4.09, 6.21]; 0.57 [0.43, 0.71]; 164.56 ng/mL [112.04, 217.08], respectively; all p<0.0001) were greater in group A than in group B. Mean difference in Ht-V for 0-6 months versus 6-12 months was 2.80 cm/year (95% CI 1.55, 4.04) for group A and -4.60 cm/year (95% CI -6.12, -3.09; both p<0.0001) for group B. No unexpected AEs were reported. CONCLUSIONS During the first 6 months, height was significantly increased in GH-treated patients versus untreated patients with ISS. Safety of GH was consistent with the known safety profile.",2020,both p<0.0001) for group,"['Patients with Idiopathic Short Stature in Korea ', 'paediatric patients with idiopathic short stature (ISS) in Korea', 'Pre-pubertal patients (mean age 6.2 years; height, 107.1 cm']","['growth hormone (GH) therapy (Norditropin®', 'GH', 'GH treatment', 'Human Growth Hormone Therapy']","['height velocity (Ht-V), change in both height standard deviation score (Ht-SDS) and insulin-like growth factor 1']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1740819', 'cui_str': 'Idiopathic short stature'}, {'cui': 'C0022771', 'cui_str': 'Korea'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C1628325', 'cui_str': 'Pre-pubertal'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517820', 'cui_str': '6.2'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}]","[{'cui': 'C0037663', 'cui_str': 'Somatotropin'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0699617', 'cui_str': 'Norditropin Simplexx'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0169964', 'cui_str': 'Somatropin'}]","[{'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0021665', 'cui_str': 'Somatomedin C'}]",,0.370607,both p<0.0001) for group,"[{'ForeName': 'Min Ho', 'Initials': 'MH', 'LastName': 'Jung', 'Affiliation': ""The Catholic University of Korea, Yeouido St. Mary's Hospital, Seoul, South Korea.""}, {'ForeName': 'Byung-Kyu', 'Initials': 'BK', 'LastName': 'Suh', 'Affiliation': ""The Catholic University of Korea, Seoul St. Mary's Hospital, Seoul, South Korea.""}, {'ForeName': 'Cheol Woo', 'Initials': 'CW', 'LastName': 'Ko', 'Affiliation': 'Kyungpook National University Hospital, Daegu, South Korea.'}, {'ForeName': 'Kee-Hyoung', 'Initials': 'KH', 'LastName': 'Lee', 'Affiliation': 'Korea University Anam Hospital, Seoul, South Korea.'}, {'ForeName': 'Dong-Kyu', 'Initials': 'DK', 'LastName': 'Jin', 'Affiliation': 'Samsung Medical Center, Sung Kyun Kwan University, Seoul, South Korea.'}, {'ForeName': 'Han-Wook', 'Initials': 'HW', 'LastName': 'Yoo', 'Affiliation': 'Asan Medical Center, Seoul, South Korea.'}, {'ForeName': 'Jin Soon', 'Initials': 'JS', 'LastName': 'Hwang', 'Affiliation': 'Ajou University Hospital, Suwon, South Korea.'}, {'ForeName': 'Woo Yeong', 'Initials': 'WY', 'LastName': 'Chung', 'Affiliation': 'Inje University Busan Paik Hospital, Busan, South Korea.'}, {'ForeName': 'Heon-Seok', 'Initials': 'HS', 'LastName': 'Han', 'Affiliation': 'Chungbuk National University Hospital, Chungbuk National University College of Medicine, Cheongju, South Korea.'}, {'ForeName': 'Vinay', 'Initials': 'V', 'LastName': 'Prusty', 'Affiliation': 'Novo Nordisk Pharma Gulf FZ-LLC, Dubai, United Arab Emirates.'}, {'ForeName': 'Ho-Seong', 'Initials': 'HS', 'LastName': 'Kim', 'Affiliation': 'Severance Hospital, Yonsei University Health System, Seoul, South Korea.'}]",European endocrinology,['10.17925/EE.2020.16.1.54'] 2171,32589738,"A Phase 2, Multicenter Study of Nevanimibe for the Treatment of Congenital Adrenal Hyperplasia.","CONTEXT Patients with classic congenital adrenal hyperplasia (CAH) often require supraphysiologic glucocorticoid doses to suppress adrenocorticotropic hormone (ACTH) and control androgen excess. Nevanimibe hydrochloride (ATR-101), which selectively inhibits adrenal cortex function, might reduce androgen excess independent of ACTH and thus allow for lower glucocorticoid dosing in CAH. 17-hydroxyprogesterone (17-OHP) and androstenedione are CAH biomarkers used to monitor androgen excess. OBJECTIVE Evaluate the efficacy and safety of nevanimibe in subjects with uncontrolled classic CAH. DESIGN This was a multicenter, single-blind, dose-titration study. CAH subjects with baseline 17-OHP ≥4× the upper limit of normal (ULN) received the lowest dose of nevanimibe for 2 weeks followed by a single-blind 2-week placebo washout. Nevanimibe was gradually titrated up if the primary outcome measure (17-OHP ≤2× ULN) was not met. A total of 5 nevanimibe dose levels were possible (125, 250, 500, 750, 1000 mg twice daily). RESULTS The study enrolled 10 adults: 9 completed the study, and 1 discontinued early due to a related serious adverse event. At baseline, the mean age was 30.3 ± 13.8 years, and the maintenance glucocorticoid dose, expressed as hydrocortisone equivalents, was 24.7 ± 10.4 mg/day. Two subjects met the primary endpoint, and 5 others experienced 17-OHP decreases ranging from 27% to 72% during nevanimibe treatment. The most common side effects were gastrointestinal (30%). There were no dose-related trends in adverse events. CONCLUSIONS Nevanimibe decreased 17-OHP levels within 2 weeks of treatment. Larger studies of longer duration are needed to further evaluate its efficacy as add-on therapy for CAH.",2020,"There were no dose-related trends in adverse events. ","['CAH subjects with baseline 17-OHP ≥ 4x the upper limit of normal (ULN', 'Congenital Adrenal Hyperplasia', 'subjects with uncontrolled classic CAH', 'The study enrolled 10 adults', 'Patients with classic congenital adrenal hyperplasia (CAH']","['nevanimibe', 'Nevanimibe', '17-hydroxyprogesterone', 'Nevanimibe hydrochloride (ATR-101', 'placebo']","['efficacy and safety', '17-OHP', 'adverse events', '17-OHP levels']","[{'cui': 'C0001627', 'cui_str': 'Congenital adrenal hyperplasia'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0202075', 'cui_str': '17 Hydroxyprogesterone measurement'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0205318', 'cui_str': 'Uncontrolled'}, {'cui': 'C0439658', 'cui_str': 'Classic'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0045010', 'cui_str': '17-alpha-Hydroxyprogesterone'}, {'cui': 'C3831455', 'cui_str': 'ATR-101'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0202075', 'cui_str': '17 Hydroxyprogesterone measurement'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",10.0,0.044986,"There were no dose-related trends in adverse events. ","[{'ForeName': 'Diala', 'Initials': 'D', 'LastName': 'El-Maouche', 'Affiliation': 'Division of Endocrinology & Metabolism, George Washington University, Washington, DC.'}, {'ForeName': 'Deborah P', 'Initials': 'DP', 'LastName': 'Merke', 'Affiliation': 'The National Institutes of Health Clinical Center, Bethesda, Maryland.'}, {'ForeName': 'Maria G', 'Initials': 'MG', 'LastName': 'Vogiatzi', 'Affiliation': ""Division of Endocrinology and Diabetes, Children's Hospital of Pennsylvania, Philadelphia, Pennsylvania.""}, {'ForeName': 'Alice Y', 'Initials': 'AY', 'LastName': 'Chang', 'Affiliation': 'Division of Endocrinology, Diabetes, Metabolism, and Nutrition, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Adina F', 'Initials': 'AF', 'LastName': 'Turcu', 'Affiliation': 'Division of Metabolism, Endocrinology, and Diabetes, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Elizabeth G', 'Initials': 'EG', 'LastName': 'Joyal', 'Affiliation': 'The National Institutes of Health Clinical Center, Bethesda, Maryland.'}, {'ForeName': 'Vivian H', 'Initials': 'VH', 'LastName': 'Lin', 'Affiliation': 'Millendo Therapeutics US, Inc, Ann Arbor, Michigan.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Weintraub', 'Affiliation': 'Millendo Therapeutics US, Inc, Ann Arbor, Michigan.'}, {'ForeName': 'Marianne R', 'Initials': 'MR', 'LastName': 'Plaunt', 'Affiliation': 'Millendo Therapeutics US, Inc, Ann Arbor, Michigan.'}, {'ForeName': 'Pharis', 'Initials': 'P', 'LastName': 'Mohideen', 'Affiliation': 'Millendo Therapeutics US, Inc, Ann Arbor, Michigan.'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Auchus', 'Affiliation': 'Division of Metabolism, Endocrinology, and Diabetes, University of Michigan, Ann Arbor, Michigan.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgaa381'] 2172,32589828,"Oral Administration of S-Adenosylmethionine (SAMe) and Lactobacillus Plantarum HEAL9 Improves the Mild-To-Moderate Symptoms of Depression: A Randomized, Double-Blind, Placebo-Controlled Study.","Objective To assess the effects of the combination of SAMe (S-adenosylmethionine) 200 mg and Lactobacillus plantarum (L. plantarum) HEAL9 1 × 10⁹ CFU for the overall symptomatology of mild-to-moderate depression. Methods This 6-week randomized, double-blind, placebo-controlled study included subjects aged 18-60 years with mild-to-moderate depression (according to ICD-10 diagnostic criteria) recruited from September 17, 2018, to October 5, 2018. Difference between groups in change from baseline to treatment week 6 on the Zung Self-Rating Depression Scale (Z-SDS) was the primary outcome. Comparisons between groups in change from baseline to treatment week 2 of the Z-SDS and from baseline to treatment weeks 2 and 6 of other scales (related to insomnia, anxiety, irritable bowel syndrome, and health status) were also analyzed. Results Ninety patients were randomized to SAMe plus L. plantarum HEAL9 (n = 46) or placebo (n = 44) groups. A greater reduction for the new combination compared to placebo was seen at treatment week 6 in the Z-SDS total score (P = .0165) and the core depression subdomain (P = .0247). A significant reduction in favor of the combination was shown at treatment week 2 for the Z-SDS total score (P = .0330), the cognitive and anxiety subdomains (P = .0133 and P = .0459, respectively), and the anxiety questionnaire (P = .0345). No treatment-related adverse events occurred. Conclusions Supplementation of SAMe and L. plantarum HEAL9 in adults with subthreshold or mild-to-moderate symptoms of depression resulted in fast and clinically relevant effects after 2 weeks. The combination was safe and significantly improved symptoms of depression, anxiety, and cognitive and somatic components. The effect of this novel product is independent from the severity of the symptoms unlike traditional antidepressants available on the market that have minimal benefits for subthreshold or mild-to-moderate symptoms. Trial Registration ClinicalTrials.gov identifier: NCT03932474.",2020,A greater reduction for the new combination compared to placebo was seen at treatment week 6 in the Z-SDS total score (P = .0165) and the core depression subdomain (P = .0247).,"['adults with subthreshold or mild-to-moderate symptoms of depression', 'Ninety patients', 'subjects aged 18-60 years with mild-to-moderate depression (according to ICD-10 diagnostic criteria) recruited from September 17, 2018, to October 5, 2018']","['SAMe plus L. plantarum HEAL9', 'Placebo', 'S-Adenosylmethionine (SAMe) and Lactobacillus Plantarum HEAL9', 'HEAL9', 'SAMe (S-adenosylmethionine) 200 mg and Lactobacillus plantarum (L. plantarum', 'placebo']","['anxiety questionnaire', 'cognitive and anxiety subdomains', 'Zung Self-Rating Depression Scale', 'insomnia, anxiety, irritable bowel syndrome, and health status', 'Z-SDS total score', 'symptoms of depression, anxiety, and cognitive and somatic components']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C1137110', 'cui_str': 'ICD-10'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1231534', 'cui_str': 'Curtobacterium plantarum'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0036002', 'cui_str': 'S-Adenosylmethionine'}, {'cui': 'C0317608', 'cui_str': 'Lactobacillus plantarum'}, {'cui': 'C4319558', 'cui_str': '200'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0451593', 'cui_str': 'Zung self-rating depression scale'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C1257909', 'cui_str': 'Diploid Cell'}, {'cui': 'C0449432', 'cui_str': 'Component'}]",90.0,0.332771,A greater reduction for the new combination compared to placebo was seen at treatment week 6 in the Z-SDS total score (P = .0165) and the core depression subdomain (P = .0247).,"[{'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Saccarello', 'Affiliation': 'Private practice, Genova, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Montarsolo', 'Affiliation': 'Private practice, Genova, Italy.'}, {'ForeName': 'Ivano', 'Initials': 'I', 'LastName': 'Massardo', 'Affiliation': 'Private practice, Genova, Italy.'}, {'ForeName': 'Rinaldo', 'Initials': 'R', 'LastName': 'Picciotto', 'Affiliation': 'Private practice, Genova, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Pedemonte', 'Affiliation': 'Private practice, Genova, Italy.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Castagnaro', 'Affiliation': 'Private practice, Genova, Italy.'}, {'ForeName': 'Pier Claudio', 'Initials': 'PC', 'LastName': 'Brasesco', 'Affiliation': 'Private practice, Genova, Italy.'}, {'ForeName': 'Vittorio', 'Initials': 'V', 'LastName': 'Guida', 'Affiliation': 'Private practice, Genova, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Picco', 'Affiliation': 'Private practice, Genova, Italy.'}, {'ForeName': 'Pino', 'Initials': 'P', 'LastName': 'Fioravanti', 'Affiliation': 'Hippocrates Research SRL, Genova, Italy.'}, {'ForeName': 'Roberta', 'Initials': 'R', 'LastName': 'Montisci', 'Affiliation': 'Hippocrates Research SRL, Genova, Italy.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Schiavetti', 'Affiliation': 'Hippocrates Research SRL, Via XX Settembre, 30/12, 16121 Genova, Italy. i.schiavetti@hippocrates-research.it.'}, {'ForeName': 'Arianna', 'Initials': 'A', 'LastName': 'Vanelli', 'Affiliation': 'Nutrilinea SRL, Varese, Italy.'}]",The primary care companion for CNS disorders,['10.4088/PCC.19m02578'] 2173,32589857,Relationship between interleukin-13 rs20541 single nucleotide polymorphisms and therapeutic efficacy in children with asthma.,"OBJECTIVE To investigate the relationship between therapeutic efficacy in children with asthma and interleukin-13 (IL-13) rs20541 polymorphisms. METHODS Fifty children with moderate-to-severe asthma were assigned to the GG, GA, and AA groups according to the IL-13 gene locus rs20541 polymorphism. The patients received budesonide inhalation suspension 1 mg twice daily combined with fluticasone propionate 80 µg/inhalation. The improvement of clinical symptoms (gasping, coughing, and wheezing), improvement of lung function, and adverse reactions were observed. RESULTS Lung function did not significantly differ among three groups before treatment. After treatment, the time to symptom relief was significantly shorter in the GG group than that in the other two groups. The forced expiratory volume in one second and percent predicted peak expiratory flow were also significantly better in the GG group than in the other two groups. CONCLUSION Budesonide inhalation suspension combined with fluticasone propionate is an effective treatment regimen for moderate-to-severe asthma. Polymorphism of the IL-13 rs20541 locus may be correlated with therapeutic efficacy. Patients carrying the GG allele were more responsive than their counterparts with the GA or AA allele.",2020,"The forced expiratory volume in one second and percent predicted peak expiratory flow were also significantly better in the GG group than in the other two groups. ","['moderate-to-severe asthma', 'children with asthma', 'children with asthma and interleukin-13 (IL-13) rs20541 polymorphisms', 'Fifty children with moderate-to-severe asthma']","['budesonide inhalation suspension 1 mg twice daily combined with fluticasone propionate 80 µg/inhalation', 'fluticasone propionate']","['time to symptom relief', 'clinical symptoms (gasping, coughing, and wheezing), improvement of lung function, and adverse reactions', 'forced expiratory volume', 'Lung function', 'peak expiratory flow']","[{'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0214743', 'cui_str': 'Interleukin 13'}, {'cui': 'C0032529', 'cui_str': 'Genetic polymorphism'}]","[{'cui': 'C4745751', 'cui_str': 'Budesonide Inhalation Suspension'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0117996', 'cui_str': 'Fluticasone propionate'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0564405', 'cui_str': 'Feeling relief'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0425449', 'cui_str': 'Gasping for breath'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0043144', 'cui_str': 'Wheezing'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}]",50.0,0.0209337,"The forced expiratory volume in one second and percent predicted peak expiratory flow were also significantly better in the GG group than in the other two groups. ","[{'ForeName': 'Lixiao', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Shanghai Pudong Hospital, Shanghai, China.'}, {'ForeName': 'Dongmei', 'Initials': 'D', 'LastName': 'Yue', 'Affiliation': 'Jinan Maternity and Child Care Hospital, Shandong, China.'}, {'ForeName': 'Lan', 'Initials': 'L', 'LastName': 'Hu', 'Affiliation': ""Children's Hospital of Fudan University, Shanghai, China.""}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Wang', 'Affiliation': 'Shanghai Pudong Hospital, Shanghai, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': 'Shanghai Pudong Hospital, Shanghai, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Liao', 'Affiliation': 'Shanghai Pudong Hospital, Shanghai, China.'}]",The Journal of international medical research,['10.1177/0300060520929179'] 2174,32590251,The treatment of V2 + V3 idiopathic trigeminal neuralgia using peripheral nerve radiofrequency thermocoagulation via the foramen rotundum and foramen ovale compared with semilunar ganglion radiofrequency thermocoagulation.,"OBJECTIVES To compare the advantages and disadvantages of V2 + V3 idiopathic trigeminal neuralgia using peripheral nerve radiofrequency (RF) thermocoagulation (PRF) via the foramen rotundum (FR) and foramen ovale (FO) with those of semilunar ganglion RF thermocoagulation (GRF) under local anesthesia, for exploring a new and available surgical method for patients with V2 + V3 idiopathic trigeminal neuralgia. PATIENTS AND METHODS 102 patients with V2 + V3 idiopathic trigeminal neuralgia were enrolled in this prospective randomized controlled clinical trial, and they were divided into the PRF and GRF group randomly (n = 51 in both groups). The outcome of pain relief was assessed using the Barrow Neurological Institute (BNI) pain score, and grouped as good (BNI Class I or II, no medication required) and bad (BNI Class III-V, medication required or failed). Recurrence was defined as a relapse to a previous lower level after attainment of any higher level of pain relief. The immediate effective rate, the 2-year postoperative effective rate, the 2-year postoperative recurrence rate, and the number of complications were observed and recorded. RESULTS Their basic conditions (age, gender ratio, side of pain, and disease duration) were similar. Furthermore, we found that the 2-year postoperative effective rate between them had no significant difference. By comparing the two groups, PRF group had the better immediate effective rate of the V2 branch and no severe complications such as corneal ulcer, however, GRF group had lower 2-year postoperative recurrence rate of the V3 branch and fewer facial swelling. CONCLUSION The PRF surgery, like GRF, is another prospective treatment for V2 + V3 idiopathic trigeminal neuralgia by virtue of its excellent immediate effect, accurate positioning and high safety.",2020,"The PRF surgery, like GRF, is another prospective treatment for V2 + V3 idiopathic trigeminal neuralgia by virtue of its excellent immediate effect, accurate positioning and high safety.","['patients with V2\u202f+\u202fV3 idiopathic trigeminal neuralgia', '102 patients with V2\u202f+\u202fV3 idiopathic trigeminal neuralgia']","['PRF and GRF', 'V2\u202f+\u202fV3 idiopathic trigeminal neuralgia using peripheral nerve radiofrequency thermocoagulation via the foramen rotundum and foramen ovale compared with semilunar ganglion radiofrequency thermocoagulation', 'semilunar ganglion RF thermocoagulation (GRF', 'V2\u202f+\u202fV3 idiopathic trigeminal neuralgia using peripheral nerve radiofrequency (RF) thermocoagulation (PRF) via the foramen rotundum (FR) and foramen ovale (FO']","['facial swelling', 'pain relief', 'Recurrence', 'immediate effective rate, the 2-year postoperative effective rate, the 2-year postoperative recurrence rate, and the number of complications', '2-year postoperative effective rate', 'immediate effective rate of the V2 branch and no severe complications such as corneal ulcer', 'Barrow Neurological Institute (BNI) pain score, and grouped as good (BNI Class I or II, no medication required) and bad (BNI Class III-V, medication required or failed', '2-year postoperative recurrence rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0393786', 'cui_str': 'Idiopathic trigeminal neuralgia'}]","[{'cui': 'C0031119', 'cui_str': 'Peripheral nerve structure'}, {'cui': 'C0013804', 'cui_str': 'Electrocoagulation'}, {'cui': 'C0017067', 'cui_str': 'Structure of nervous system ganglion'}, {'cui': 'C0393786', 'cui_str': 'Idiopathic trigeminal neuralgia'}, {'cui': 'C0016521', 'cui_str': 'Structure of foramen ovale of heart'}, {'cui': 'C0040995', 'cui_str': 'Structure of trigeminal ganglion'}]","[{'cui': 'C0151602', 'cui_str': 'Facial swelling'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0205384', 'cui_str': 'Branching'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0010043', 'cui_str': 'Corneal ulcer'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0441885', 'cui_str': 'Class 1'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0441887', 'cui_str': 'Class 3'}]",102.0,0.0255936,"The PRF surgery, like GRF, is another prospective treatment for V2 + V3 idiopathic trigeminal neuralgia by virtue of its excellent immediate effect, accurate positioning and high safety.","[{'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Zeng', 'Affiliation': ""Department of Pain Clinic, The First Affiliated Hospital, Nanchang University, Nanchang, Jiangxi, 330006, People's Republic of China.""}, {'ForeName': 'Mengye', 'Initials': 'M', 'LastName': 'Zhu', 'Affiliation': ""Department of Pain Clinic, The First Affiliated Hospital, Nanchang University, Nanchang, Jiangxi, 330006, People's Republic of China.""}, {'ForeName': 'Quan', 'Initials': 'Q', 'LastName': 'Wan', 'Affiliation': ""Department of Pain Clinic, Zhejiang Provincial People's Hospital, Hangzhou, Zhejiang, 310014, People's Republic of China.""}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Yan', 'Affiliation': ""Department of Pain Clinic, The First Affiliated Hospital, Nanchang University, Nanchang, Jiangxi, 330006, People's Republic of China.""}, {'ForeName': 'Changxi', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': ""Department of Pain Clinic, Subei People's Hospital, Yangzhou, Jiangsu, 225002, People's Republic of China. Electronic address: 1714452550@qq.com.""}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': ""Department of Pain Clinic, The First Affiliated Hospital, Nanchang University, Nanchang, Jiangxi, 330006, People's Republic of China. Electronic address: zy830226@163.com.""}]",Clinical neurology and neurosurgery,['10.1016/j.clineuro.2020.106025'] 2175,32590653,Keeping the Finger on the Pulse: Cardiac Arrhythmias in Hand Surgery Using Local Anesthesia with Adrenaline.,"BACKGROUND The wide-awake local anesthesia no tourniquet (WALANT) technique in hand surgery is gaining popularity. The authors aimed to prospectively analyze the frequency and type of arrhythmias in patients undergoing hand surgery under local anesthesia and to examine whether the addition of adrenaline affects their incidence. METHODS Adult patients undergoing hand surgery under local anesthesia were randomized into two groups: group 1, local anesthesia with lidocaine and tourniquet; and group 2, local anesthesia with lidocaine and adrenaline (WALANT). Patients with a history of arrhythmias were excluded. Patients were connected to Holter electrocardiographic monitoring before surgery and up until discharge. The records were blindly compared between the groups regarding types of arrhythmias, and frequency and timing relative to injection and tourniquet inflation. RESULTS One hundred two patients were included between August of 2018 and August of 2019 (age, 59.7 ± 13.6 years; 71 percent women; 51 in each group). No major arrhythmia (ventricular tachycardia, ventricular fibrillation, atrial fibrillation) or arrhythmia-related symptoms were recorded for either group. Minor arrhythmias (including atrial premature beats, ventricular premature beats, and atrial tachycardia) were recorded in 68 patients (66.6 percent), with no statistical difference between the groups. There were three patients with minor arrhythmias during inflation of the tourniquet. Patients in the adrenaline group had 2 percent sinus tachycardia during injection and 4 percent asymptomatic bradyarrhythmias. These findings do not require any further treatment. CONCLUSIONS The authors' results show that hand operations using WALANT technique in patients with no history of arrhythmia are safe and are not arrhythmogenic; therefore, there is no need for routine perioperative continuous electrocardiographic monitoring. CLINICAL QUESTION/LEVEL OF EVIDENCE Therapeutic, II.",2020,"No major arrhythmia (ventricular tachycardia, ventricular fibrillation, atrial fibrillation) or arrhythmia-related symptoms were recorded for either group.","['One hundred two patients were included between August of 2018 and August of 2019 (age, 59.7 ± 13.6 years; 71 percent women; 51 in each group', 'Patients with a history of arrhythmias were excluded', 'Adult patients undergoing hand surgery under local anesthesia', 'patients undergoing hand surgery under local anesthesia']","['adrenaline', 'Adrenaline', 'local anesthesia with lidocaine and tourniquet; and group 2, local anesthesia with lidocaine and adrenaline (WALANT']","['Minor arrhythmias (including atrial premature beats, ventricular premature beats, and atrial tachycardia', 'sinus tachycardia', 'major arrhythmia (ventricular tachycardia, ventricular fibrillation, atrial fibrillation) or arrhythmia-related symptoms']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517560', 'cui_str': '13.6'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0003811', 'cui_str': 'Cardiac arrhythmia'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0187067', 'cui_str': 'Operative procedure on hand'}, {'cui': 'C1720162', 'cui_str': 'Under local anesthesia'}]","[{'cui': 'C0014563', 'cui_str': 'Epinephrine'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0040519', 'cui_str': 'Tourniquet'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0234422', 'cui_str': 'Awake'}]","[{'cui': 'C0026193', 'cui_str': 'Minor'}, {'cui': 'C0003811', 'cui_str': 'Cardiac arrhythmia'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0033036', 'cui_str': 'Atrial premature complex'}, {'cui': 'C0151636', 'cui_str': 'Ventricular premature beats'}, {'cui': 'C0030587', 'cui_str': 'Atrial paroxysmal tachycardia'}, {'cui': 'C0039239', 'cui_str': 'Sinus tachycardia'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0042514', 'cui_str': 'Ventricular tachycardia'}, {'cui': 'C0042510', 'cui_str': 'Ventricular fibrillation'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",3.0,0.0466821,"No major arrhythmia (ventricular tachycardia, ventricular fibrillation, atrial fibrillation) or arrhythmia-related symptoms were recorded for either group.","[{'ForeName': 'Uri', 'Initials': 'U', 'LastName': 'Farkash', 'Affiliation': 'Ashdod and Beer-Sheva, Israel From the Hand Surgery Unit, the Department of Orthopedic Surgery, and the Electrophysiology and Pacing Unit, Cardiology Department, Assuta Ashdod University Hospital; and the Faculty of Health Sciences, Ben-Gurion University of the Negev.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Herman', 'Affiliation': ''}, {'ForeName': 'Tal', 'Initials': 'T', 'LastName': 'Kalimian', 'Affiliation': ''}, {'ForeName': 'Ohad', 'Initials': 'O', 'LastName': 'Segal', 'Affiliation': ''}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Cohen', 'Affiliation': ''}, {'ForeName': 'Avishag', 'Initials': 'A', 'LastName': 'Laish-Farkash', 'Affiliation': ''}]",Plastic and reconstructive surgery,['10.1097/PRS.0000000000006902'] 2176,32590804,A new interspinous process distraction device BacFuse in the treatment of lumbar spinal stenosis with 5 years follow-up study.,"To explore a suitable indication of interspinous process distraction device for lumbar spinal stenosis with BacFuse.Patients of lumbar spinal stenosis (LSS) who experienced interspinous process distraction device surgery with BacFuse from June 2014 to January 2015 in our institute were included. We classified LSS into central and lateral types, and then divided these into severe and moderate according to the degree of stenosis. Each type was divided into 2 groups. Patients in group A underwent distraction without bone decompression (stand-alone), while patients in group B underwent bone decompression combined with distraction. Follow-up was performed at 1 month, 3 months, 6 months, 2 years, and 5 years after surgery. Zurich Claudication Questionnaire (ZCQ) was recorded to assess the patient's postoperative condition at each follow-up.A total of 142 patients were available for follow up at each time interval. There was a significant difference between the preoperative and final follow-up ZCQ scores for every LSS type. In addition, there was no difference between group A and group B in the postoperative ZCQ scores with the exception of the lateral severe type. In the study, 22 of the 23 patients (95.65%) in the lateral moderate type were considered to have a satisfactory result in group B, with a similar result of 93.33% (14/15) in group A (P = .75). In the lateral severe type, the patient satisfaction rate was 65.22% (15/23) and 90.63% (29/32) in group A and group B (P = .02), respectively. In the central moderate type, the patient satisfaction rate was 81.82% (15/23) and 76.92% (10/13) in group A and group B (P = .77), respectively. Satisfaction rate for the follow-up results in the central severe type reached 57.14% (4/7) in group A, and 54.55% (6/11) in group B (P = .91). Moreover, no relationship was found between satisfaction and neurogenic intermittent claudication.The most suitable indication for BacFuse treatment was the lateral moderate type. For lateral severe patients, distraction combined with decompression is suggested for a higher satisfaction rate. Severe central spinal stenosis was shown to be a relative contraindication for BacFuse.",2020,"Satisfaction rate for the follow-up results in the central severe type reached 57.14% (4/7) in group A, and 54.55% (6/11) in group B (P = .91).","['lumbar spinal stenosis with BacFuse', 'Patients of lumbar spinal stenosis (LSS) who experienced interspinous process distraction device surgery with BacFuse from June 2014 to January 2015 in our institute were included', '142 patients were available for follow up at each time interval']","['interspinous process distraction device', 'distraction without bone decompression (stand-alone', 'bone decompression combined with distraction']","['Severe central spinal stenosis', 'satisfaction and neurogenic intermittent claudication', 'patient satisfaction rate', 'postoperative ZCQ scores', 'Zurich Claudication Questionnaire (ZCQ', 'Satisfaction rate']","[{'cui': 'C0158288', 'cui_str': 'Spinal stenosis of lumbar region'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0150189', 'cui_str': 'Distraction training'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1272706', 'cui_str': 'Interval'}]","[{'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0150189', 'cui_str': 'Distraction training'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0011117', 'cui_str': 'Decompression'}, {'cui': 'C0560204', 'cui_str': 'Does stand alone'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0037944', 'cui_str': 'Spinal stenosis'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0021775', 'cui_str': 'Intermittent claudication'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",142.0,0.020344,"Satisfaction rate for the follow-up results in the central severe type reached 57.14% (4/7) in group A, and 54.55% (6/11) in group B (P = .91).","[{'ForeName': 'Mengmeng', 'Initials': 'M', 'LastName': 'Chen', 'Affiliation': ""Department of Orthopedics, Beijing Friendship Hospital, Capital Medical University, Beijing, People's Republic of China.""}, {'ForeName': 'Hai', 'Initials': 'H', 'LastName': 'Tang', 'Affiliation': ''}, {'ForeName': 'Jianlin', 'Initials': 'J', 'LastName': 'Shan', 'Affiliation': ''}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': ''}, {'ForeName': 'Pu', 'Initials': 'P', 'LastName': 'Jia', 'Affiliation': ''}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Bao', 'Affiliation': ''}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Feng', 'Affiliation': ''}, {'ForeName': 'Guan', 'Initials': 'G', 'LastName': 'Shi', 'Affiliation': ''}, {'ForeName': 'Ruideng', 'Initials': 'R', 'LastName': 'Wang', 'Affiliation': ''}]",Medicine,['10.1097/MD.0000000000020925'] 2177,32590809,"The efficacy and safety of sulforaphane as an adjuvant in the treatment of bipolar depressive disorder: Study protocol for a randomized, double-blinded, placebo-controlled, parallel-group clinical trial.","BACKGROUND Bipolar disorder (BD) is a chronic and disabling psychiatric disorder. The treatment of BD still remains a significant clinical challenge due to the complex nature of the disease. Nutraceutical therapy as adjunctive role is a promising therapy for BD. Sulforaphane (SFN), a broccoli extract, was reported to be effective for emotional problems and cognitive impairment. However, clinical research of SFN in the treatment of BD was rare. Therefore, this study is designed to evaluate the adjuvant role of SFN in the treatment of BD. METHODS This is a randomized, double-blinded, placebo-controlled, parallel-group clinical trial. A total of 100 patients who meet inclusion criteria will be assigned to receive quetiapine plus SFN or quetiapine plus placebo in a 1:1 ratio. The total duration of the study will be 12 weeks including 5 follow ups. The primary outcome is in the Montgomery-Asberg depression rating scale. The secondary outcomes are the quick inventory of depressive symptomatology-self report, Hamilton anxiety rating scale, young mania rating scale, cognitive function, inflammatory factors, and intestinal flora. Any adverse events will be recorded throughout the trial. DISCUSSION This trial will provide evidences to evaluate the efficacy and safety of SFN combined with quetiapine in the treatment of BD patients, as well as the adjuvant role of SFN in combination. TRIAL REGISTRATION This study protocol was registered at the Chinese clinical trial registry (ChiCTR2000028706).",2020,"The secondary outcomes are the quick inventory of depressive symptomatology-self report, Hamilton anxiety rating scale, young mania rating scale, cognitive function, inflammatory factors, and intestinal flora.","['bipolar depressive disorder', '100 patients who meet inclusion criteria will be assigned to receive']","['Sulforaphane (SFN), a broccoli extract', 'sulforaphane', 'quetiapine plus SFN or quetiapine plus placebo', 'SFN combined with quetiapine', 'SFN', 'placebo']","['efficacy and safety', 'Montgomery-Asberg depression rating scale', 'quick inventory of depressive symptomatology-self report, Hamilton anxiety rating scale, young mania rating scale, cognitive function, inflammatory factors, and intestinal flora']","[{'cui': 'C0443156', 'cui_str': 'Bipolar'}, {'cui': 'C0011581', 'cui_str': 'Depressive disorder'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}]","[{'cui': 'C0163159', 'cui_str': 'sulforafan'}, {'cui': 'C4723687', 'cui_str': 'broccoli extract'}, {'cui': 'C0123091', 'cui_str': 'quetiapine'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C4720917', 'cui_str': 'Quick inventory of depressive symptomatology'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C4087288', 'cui_str': 'Young mania rating scale'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}]",100.0,0.340506,"The secondary outcomes are the quick inventory of depressive symptomatology-self report, Hamilton anxiety rating scale, young mania rating scale, cognitive function, inflammatory factors, and intestinal flora.","[{'ForeName': 'Congchong', 'Initials': 'C', 'LastName': 'Wu', 'Affiliation': 'Department of Psychiatry, The First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou.'}, {'ForeName': 'Xingyang', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': ""Taizhou Second People's Hospital, Taizhou.""}, {'ForeName': 'Jianbo', 'Initials': 'J', 'LastName': 'Lai', 'Affiliation': 'Department of Psychiatry, The First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Xu', 'Affiliation': 'Department of Psychiatry, The First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou.'}, {'ForeName': 'Shaohua', 'Initials': 'S', 'LastName': 'Hu', 'Affiliation': 'Department of Psychiatry, The First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou.'}]",Medicine,['10.1097/MD.0000000000020981'] 2178,32590942,Pharmacokinetic study of two different rifabutin doses co-administered with lopinavir/ritonavir in African HIV and tuberculosis co-infected adult patients.,"BACKGROUND This study aimed to assess the pharmacokinetic profile of 150 mg rifabutin (RBT) taken every other day (every 48 h) versus 300 mg RBT taken every other day (E.O.D), both in combination with lopinavir/ritonavir (LPV/r), in adult patients with human immunodeficiency virus (HIV) and tuberculosis (TB) co-infection. METHODS This is a two-arm, open-label, pharmacokinetic, randomised study conducted in Burkina Faso between May 2013 and December 2015. Enrolled patients were randomised to receive either 150 mg RBT EOD (arm A, 9 subjects) or 300 mg RBT EOD (arm B, 7 subjects), both associated with LPV/r taken twice daily. RBT plasma concentrations were evaluated after 2 weeks of combined HIV and TB treatment. Samples were collected just before drug ingestion and at 1, 2, 3, 4, 6, 8, and 12 h after drug ingestion to measure plasma drug concentration using an HPLC-MS/MS assay. RESULTS The Cmax and AUC 0-12h medians in arm A (Cmax = 296 ng/mL, IQR: 205-45; AUC 0-12h  = 2528 ng.h/mL, IQR: 1684-2735) were lower than those in arm B (Cmax = 600 ng/mL, IQR: 403-717; AUC 0-12h  = 4042.5 ng.h/mL, IQR: 3469-5761), with a statistically significant difference in AUC 0-12h (p = 0.044) but not in Cmax (p = 0.313). No significant differences were observed in Tmax (3 h versus 4 h). Five patients had a Cmax below the plasma therapeutic limit (< 300 ng/mL) in the 150 mg RBT arm, while the Cmax was above this threshold for all patients in the 300 mg RBT arm. Additionally, at 48 h after drug ingestion, all patients had a mycobacterial minimum inhibitory concentration (MIC) above the limit (> 64 ng/mL) in the 300 mg RBT arm, while 4/9 patients had such values in the 150 mg RBT arm. CONCLUSION This study confirmed that the 150 mg dose of rifabutin ingested EOD in combination with LPV/r is inadequate and could lead to selection of rifamycin-resistant mycobacteria. TRIAL REGISTRATION PACTR201310000629390, 28th October 2013.",2020,"Five patients had a Cmax below the plasma therapeutic limit (< 300 ng/mL) in the 150 mg RBT arm, while the Cmax was above this threshold for all patients in the 300 mg RBT arm.","['Burkina Faso between May 2013 and December 2015', 'African HIV and tuberculosis co-infected adult patients', 'adult patients with human immunodeficiency virus (HIV) and tuberculosis (TB']","['rifabutin ingested EOD', 'rifabutin doses co-administered with lopinavir/ritonavir', '300\u2009mg RBT EOD', '150\u2009mg RBT EOD', 'lopinavir/ritonavir (LPV/r', 'rifabutin (RBT']","['RBT plasma concentrations', 'Cmax below the plasma therapeutic limit', 'Tmax', 'mycobacterial minimum inhibitory concentration (MIC', 'Cmax and AUC']","[{'cui': 'C0006409', 'cui_str': 'Burkina Faso'}, {'cui': 'C0027567', 'cui_str': 'African race'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0041296', 'cui_str': 'Tuberculosis'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0140575', 'cui_str': 'Rifabutin'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0939237', 'cui_str': 'lopinavir and ritonavir'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C4321486', 'cui_str': '150'}]","[{'cui': 'C0140575', 'cui_str': 'Rifabutin'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0427978', 'cui_str': 'MIC'}, {'cui': 'C0066256', 'cui_str': 'Methyl isocyanate'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}]",2735.0,0.0847334,"Five patients had a Cmax below the plasma therapeutic limit (< 300 ng/mL) in the 150 mg RBT arm, while the Cmax was above this threshold for all patients in the 300 mg RBT arm.","[{'ForeName': 'Seni', 'Initials': 'S', 'LastName': 'Kouanda', 'Affiliation': 'Biomedical and Public Health Department, Institut de Recherche en Sciences de la Santé (IRSS), Ouagadougou, 03BP7192, Burkina Faso. skouanda@irss.bf.'}, {'ForeName': 'Henri Gautier', 'Initials': 'HG', 'LastName': 'Ouedraogo', 'Affiliation': 'Biomedical and Public Health Department, Institut de Recherche en Sciences de la Santé (IRSS), Ouagadougou, 03BP7192, Burkina Faso.'}, {'ForeName': 'Kadari', 'Initials': 'K', 'LastName': 'Cisse', 'Affiliation': 'Biomedical and Public Health Department, Institut de Recherche en Sciences de la Santé (IRSS), Ouagadougou, 03BP7192, Burkina Faso.'}, {'ForeName': 'Tegwinde Rebeca', 'Initials': 'TR', 'LastName': 'Compaoré', 'Affiliation': 'Biomedical and Public Health Department, Institut de Recherche en Sciences de la Santé (IRSS), Ouagadougou, 03BP7192, Burkina Faso.'}, {'ForeName': 'Giorgia', 'Initials': 'G', 'LastName': 'Sulis', 'Affiliation': 'Department of Epidemiology, Biostatistics and Occupational Health, McGill University, Montreal, QC, Canada.'}, {'ForeName': 'Serge', 'Initials': 'S', 'LastName': 'Diagbouga', 'Affiliation': 'Biomedical and Public Health Department, Institut de Recherche en Sciences de la Santé (IRSS), Ouagadougou, 03BP7192, Burkina Faso.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Roggi', 'Affiliation': 'Institute of Infectious and Tropical Diseases, Brescia University Hospital, Brescia, Italy.'}, {'ForeName': 'Grissoum', 'Initials': 'G', 'LastName': 'Tarnagda', 'Affiliation': 'Biomedical and Public Health Department, Institut de Recherche en Sciences de la Santé (IRSS), Ouagadougou, 03BP7192, Burkina Faso.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Villani', 'Affiliation': 'Institute of Pharmacology, IRCCS, San Matteo University Hospital, Pavia, Italy.'}, {'ForeName': 'Lassana', 'Initials': 'L', 'LastName': 'Sangare', 'Affiliation': 'Yalgado Ouedraogo University Teaching Hospital, Ouagadougou, Burkina Faso.'}, {'ForeName': 'Jacques', 'Initials': 'J', 'LastName': 'Simporé', 'Affiliation': 'Centre de Recherche Biomoléculaire Pietro Annigoni (CERBA), Ouagadougou, Burkina Faso.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Regazzi', 'Affiliation': 'Institute of Pharmacology, IRCCS, San Matteo University Hospital, Pavia, Italy.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Matteelli', 'Affiliation': 'Institute of Infectious and Tropical Diseases, Brescia University Hospital, Brescia, Italy.'}]",BMC infectious diseases,['10.1186/s12879-020-05169-2'] 2179,32590944,"Efficacy and safety of intracoronary prourokinase during percutaneous coronary intervention in treating ST-segment elevation myocardial infarction patients: a randomized, controlled study.","BACKGROUND Prourokinase is a single-chain plasminogen activator presenting with fewer hemorrhagic complications and reduced reocclusion rate compared with the conventional fibrinolytic agents in patients with coronary artery disease. However, prourokinase intracoronary injection during PCI for treating patients with ST-segment elevation myocardial infarction (STEMI) is rarely investigated. Therefore, this study aimed to evaluate the efficacy and safety of intracoronary prourokinase during the percutaneous coronary intervention (PCI) in treating STEMI patients. METHODS Fifty STEMI patients who underwent primary PCI were consecutively enrolled and randomly assigned to intracoronary prourokinase group (N = 25) or control group (N = 25). During the primary PCI procedure, patients in the intracoronary prourokinase group received 10 ml prourokinase injection, while patients in control group received 10 ml saline injection as control. The primary endpoints were coronary physiological indexes, the secondary endpoints were angiographic assessments, myocardial infarct size/reperfusion assessment, cardiac function evaluations, major adverse coronary events (MACEs) and hemorrhagic complications. All patients were followed up for 3 months. RESULTS Post PCI, the index of microcirculatory resistance (IMR) was decreased in intracoronary prourokinase group than that in control group (34.56 ± 7.48 vs. 49.00 ± 8.98, P < 0.001), while no difference of coronary flow reserve (CFR) (2.01 ± 0.32 vs. 1.88 ± 0.23, P = 0.267) or fractional flow reserve (FFR) (0.89 ± 0.05 vs. 0.87 ± 0.04, P = 0.121) was found between the two groups. The thrombolysis in myocardial infarction myocardial perfusion grade (TMPG) (P = 0.024), peak values of creatine kinase (CK) (P = 0.028), CK isoenzyme-MB (CK-MB) (P = 0.016), cardiac troponin I (cTnI) (P = 0.032) and complete ST-segment resolution (STR) (P = 0.005) were better in intracoronary prourokinase group compared with control group. At 3-months post PCI, left ventricular ejection fraction (LVEF) and wall motion score index (WMSI) were higher, while left ventricular end-diastolic diameter (LVEDd) was lower in intracoronary prourokinase group compared with control group (all P < 0.05). There was no difference in hemorrhagic complication or total MACE between the two groups. CONCLUSION Intracoronary prourokinase during PCI is more efficient and equally tolerant compared with PCI alone in treating STEMI patients. TRIAL REGISTRATION Chinese Clinical Trial Registry ChiCTR1800016207 . Prospectively registered.",2020,"The thrombolysis in myocardial infarction myocardial perfusion grade (TMPG) (P = 0.024), peak values of creatine kinase (CK) (P = 0.028), CK isoenzyme-MB (CK-MB) (P = 0.016), cardiac troponin","['treating ST-segment elevation myocardial infarction patients', 'patients with ST-segment elevation myocardial infarction (STEMI', 'patients with coronary artery disease', 'Fifty STEMI patients who underwent primary PCI']","['percutaneous coronary intervention (PCI', 'conventional fibrinolytic agents', 'percutaneous coronary intervention', 'intracoronary prourokinase', '10\u2009ml saline injection', '10\u2009ml prourokinase injection']","['angiographic assessments, myocardial infarct size/reperfusion assessment, cardiac function evaluations, major adverse coronary events (MACEs) and hemorrhagic complications', 'coronary flow reserve (CFR', 'hemorrhagic complication or total MACE', 'left ventricular end-diastolic diameter (LVEDd', 'CK isoenzyme-MB (CK-MB', 'Efficacy and safety', 'I (cTnI', 'myocardial infarction myocardial perfusion grade (TMPG', 'fractional flow reserve (FFR', 'efficacy and safety', 'peak values of creatine kinase (CK', 'cardiac troponin', 'complete ST-segment resolution (STR', 'index of microcirculatory resistance (IMR', 'reocclusion rate', 'left ventricular ejection fraction (LVEF) and wall motion score index (WMSI', 'coronary physiological indexes']","[{'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C1536220', 'cui_str': 'ST Segment Elevation Myocardial Infarction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441635', 'cui_str': 'Segment'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}]","[{'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0016018', 'cui_str': 'Thrombolytic agent'}, {'cui': 'C0595454', 'cui_str': 'Intracoronary route'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0035124', 'cui_str': 'Reperfusion'}, {'cui': 'C0232164', 'cui_str': 'Cardiac function'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0333275', 'cui_str': 'Hemorrhagic'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0286421', 'cui_str': 'ACE protocol 2'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0010288', 'cui_str': 'Creatine kinase isoenzyme'}, {'cui': 'C0010290', 'cui_str': 'Creatine kinase isoenzyme, MB fraction'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0883409', 'cui_str': 'Cardiac troponin I'}, {'cui': 'C0428857', 'cui_str': 'Myocardial perfusion'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0520997', 'cui_str': 'Thrombolysis'}, {'cui': 'C1299469', 'cui_str': 'Fractional flow reserve'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0010287', 'cui_str': 'Creatine kinase'}, {'cui': 'C1096316', 'cui_str': 'Cardiac troponin'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0429029', 'cui_str': 'ST segment'}, {'cui': 'C0441635', 'cui_str': 'Segment'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0854571', 'cui_str': 'Reocclusion'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C4324428', 'cui_str': 'Wall motion score index'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}]",50.0,0.0777143,"The thrombolysis in myocardial infarction myocardial perfusion grade (TMPG) (P = 0.024), peak values of creatine kinase (CK) (P = 0.028), CK isoenzyme-MB (CK-MB) (P = 0.016), cardiac troponin","[{'ForeName': 'Yanqiang', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'Department of Cardiology, The Second Hospital of Hebei Medical University, 215 West Heping Road, Shijiazhuang, 050000, China.'}, {'ForeName': 'Xianghua', 'Initials': 'X', 'LastName': 'Fu', 'Affiliation': 'Department of Cardiology, The Second Hospital of Hebei Medical University, 215 West Heping Road, Shijiazhuang, 050000, China. dufang27481519@163.com.'}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Feng', 'Affiliation': 'Department of Cardiology, Handan Central Hospital, Handan, 056000, China.'}, {'ForeName': 'Xinshun', 'Initials': 'X', 'LastName': 'Gu', 'Affiliation': 'Department of Cardiology, The Second Hospital of Hebei Medical University, 215 West Heping Road, Shijiazhuang, 050000, China.'}, {'ForeName': 'Guozhen', 'Initials': 'G', 'LastName': 'Hao', 'Affiliation': 'Department of Cardiology, The Second Hospital of Hebei Medical University, 215 West Heping Road, Shijiazhuang, 050000, China.'}, {'ForeName': 'Weize', 'Initials': 'W', 'LastName': 'Fan', 'Affiliation': 'Department of Cardiology, The Second Hospital of Hebei Medical University, 215 West Heping Road, Shijiazhuang, 050000, China.'}, {'ForeName': 'Yunfa', 'Initials': 'Y', 'LastName': 'Jiang', 'Affiliation': 'Department of Cardiology, The Second Hospital of Hebei Medical University, 215 West Heping Road, Shijiazhuang, 050000, China.'}]",BMC cardiovascular disorders,['10.1186/s12872-020-01584-0'] 2180,32590958,"Rationale and design of ""Hearts & Parks"": study protocol for a pragmatic randomized clinical trial of an integrated clinic-community intervention to treat pediatric obesity.","BACKGROUND The prevalence of child and adolescent obesity and severe obesity continues to increase despite decades of policy and research aimed at prevention. Obesity strongly predicts cardiovascular and metabolic disease risk; both begin in childhood. Children who receive intensive behavioral interventions can reduce body mass index (BMI) and reverse disease risk. However, delivering these interventions with fidelity at scale remains a challenge. Clinic-community partnerships offer a promising strategy to provide high-quality clinical care and deliver behavioral treatment in local park and recreation settings. The Hearts & Parks study has three broad objectives: (1) evaluate the effectiveness of the clinic-community model for the treatment of child obesity, (2) define microbiome and metabolomic signatures of obesity and response to lifestyle change, and (3) inform the implementation of similar models in clinical systems. METHODS Methods are designed for a pragmatic randomized, controlled clinical trial (n = 270) to test the effectiveness of an integrated clinic-community child obesity intervention as compared with usual care. We are powered to detect a difference in body mass index (BMI) between groups at 6 months, with follow up to 12 months. Secondary outcomes include changes in biomarkers for cardiovascular disease, psychosocial risk, and quality of life. Through collection of biospecimens (serum and stool), additional exploratory outcomes include microbiome and metabolomics biomarkers of response to lifestyle modification. DISCUSSION We present the study design, enrollment strategy, and intervention details for a randomized clinical trial to measure the effectiveness of a clinic-community child obesity treatment intervention. This study will inform a critical area in child obesity and cardiovascular risk research-defining outcomes, implementation feasibility, and identifying potential molecular mechanisms of treatment response. CLINICAL TRIAL REGISTRATION NCT03339440 .",2020,"We are powered to detect a difference in body mass index (BMI) between groups at 6 months, with follow up to 12 months.",[],"['intensive behavioral interventions', 'clinic-community child obesity treatment intervention', 'integrated clinic-community child obesity intervention', 'integrated clinic-community intervention']","['body mass index (BMI) and reverse disease risk', 'changes in biomarkers for cardiovascular disease, psychosocial risk, and quality of life', 'body mass index (BMI']",[],"[{'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C0587907', 'cui_str': 'Community clinic'}, {'cui': 'C2362324', 'cui_str': 'Childhood obesity'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1281905', 'cui_str': 'At risk of disease'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",,0.0729411,"We are powered to detect a difference in body mass index (BMI) between groups at 6 months, with follow up to 12 months.","[{'ForeName': 'Sarah C', 'Initials': 'SC', 'LastName': 'Armstrong', 'Affiliation': 'Department of Pediatrics, Duke University, Durham, NC, 27710, USA.'}, {'ForeName': 'McAllister', 'Initials': 'M', 'LastName': 'Windom', 'Affiliation': 'Department of Pediatrics, Duke University, Durham, NC, 27710, USA.'}, {'ForeName': 'Nathan A', 'Initials': 'NA', 'LastName': 'Bihlmeyer', 'Affiliation': 'Duke Molecular Physiology Institute, Duke University, Durham, NC, 27710, USA.'}, {'ForeName': 'Jennifer S', 'Initials': 'JS', 'LastName': 'Li', 'Affiliation': 'Department of Pediatrics, Duke University, Durham, NC, 27710, USA.'}, {'ForeName': 'Svati H', 'Initials': 'SH', 'LastName': 'Shah', 'Affiliation': 'Duke Molecular Physiology Institute, Duke University, Durham, NC, 27710, USA.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Story', 'Affiliation': 'Department of Family Medicine and Community Health, Duke University, Durham, NC, 27710, USA.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Zucker', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Duke University, Durham, NC, 27710, USA.'}, {'ForeName': 'William E', 'Initials': 'WE', 'LastName': 'Kraus', 'Affiliation': 'Department of Medicine, Duke University, Durham, NC, 27710, USA.'}, {'ForeName': 'Neha', 'Initials': 'N', 'LastName': 'Pagidipati', 'Affiliation': 'Duke Clinical Research Institute, Duke University, Durham, NC, 27710, USA.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Peterson', 'Affiliation': 'Duke Clinical Research Institute, Duke University, Durham, NC, 27710, USA.'}, {'ForeName': 'Charlene', 'Initials': 'C', 'LastName': 'Wong', 'Affiliation': 'Department of Pediatrics, Duke University, Durham, NC, 27710, USA.'}, {'ForeName': 'Manuela', 'Initials': 'M', 'LastName': 'Wiedemeier', 'Affiliation': 'Duke Clinical Research Institute, Duke University, Durham, NC, 27710, USA.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Sibley', 'Affiliation': 'University of North Carolina School of Medicine, Chapel Hill, NC, 27516, USA.'}, {'ForeName': 'Samuel I', 'Initials': 'SI', 'LastName': 'Berchuck', 'Affiliation': 'Department of Statistical Science, Duke University, Durham, NC, 27710, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Merrill', 'Affiliation': 'Duke Clinical Research Institute, Duke University, Durham, NC, 27710, USA.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Zizzi', 'Affiliation': 'Department of Pediatrics, Duke University, Durham, NC, 27710, USA.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Sarria', 'Affiliation': 'Department of Pediatrics, Duke University, Durham, NC, 27710, USA.'}, {'ForeName': 'Holly K', 'Initials': 'HK', 'LastName': 'Dressman', 'Affiliation': 'Department of Molecular Genetics and Microbiology, Duke University, Durham, NC, 27708, USA.'}, {'ForeName': 'John F', 'Initials': 'JF', 'LastName': 'Rawls', 'Affiliation': 'Department of Molecular Genetics and Microbiology, Duke University, Durham, NC, 27708, USA.'}, {'ForeName': 'Asheley C', 'Initials': 'AC', 'LastName': 'Skinner', 'Affiliation': 'Duke Clinical Research Institute, Duke University, Durham, NC, 27710, USA. asheley.skinner@duke.edu.'}]",BMC pediatrics,['10.1186/s12887-020-02190-x'] 2181,32590959,"Evaluation of the efficacy of an internet-based pain education and exercise program for chronic musculoskeletal pain in comparison with online self-management booklet: a protocol of a randomised controlled trial with assessor-blinded, 12-month follow-up, and economic evaluation.","BACKGROUND Chronic musculoskeletal pain is one of the main causes of years lived with disability and generates the highest cost of health care among chronic pain conditions. Internet-based treatments have been shown to be an alternative for the treatment of musculoskeletal conditions, in addition to reducing barriers such as travel, high demands on the public health system, lack of time, lack of insurance coverage for private care, and high costs for long-term treatment. The aim of this clinical trial is to develop and test the effectiveness and cost-effectiveness of, an internet-based self-management program based on pain education and exercise for people with chronic musculoskeletal pain. METHODS This is a prospectively registered, assessor-blinded, two-arm randomised controlled trial with economic evaluation comparing the Internet-based pain education and exercise intervention with a control group that will receive an online booklet. One hundred and sixty patients will be recruited from Sao Paulo, Brazil. Follow-ups will be conducted in post-treatment, 6 and 12 months after randomisation. The conduct of the study, as well as the evaluations and follow-ups will be carried out entirely remotely, through online platforms and telephone calls. The primary outcome will be pain intensity at post-treatment (8 weeks) measured using the 11-item Pain Numerical Rating Scale. Secondary outcomes will be biopsychosocial factors presents in the chronic musculoskeletal pain condition. Costs due to chronic musculoskeletal pain will be also measured, and cost-effectiveness analysis from a societal perspective will performed. DISCUSSION Our hypothesis is that internet-based pain education and exercise will be better than an online booklet in reducing pain and improving biopsychosocial outcomes in patients with chronic musculoskeletal pain. In addition, we believe that there will be good acceptance of patients for the internet-based intervention and that internet-based intervention will be more cost effective than the online booklet. TRIAL REGISTRATION The study was prospectively registered at ClinicalTrials.gov ( NCT04274439 , registered 18 February 2020).",2020,"Internet-based treatments have been shown to be an alternative for the treatment of musculoskeletal conditions, in addition to reducing barriers such as travel, high demands on the public health system, lack of time, lack of insurance coverage for private care, and high costs for long-term treatment.","['people with chronic musculoskeletal pain', 'patients with chronic musculoskeletal pain', 'One hundred and sixty patients will be recruited from Sao Paulo, Brazil']","['online self-management booklet', 'internet-based pain education and exercise program', 'internet-based self-management program based on pain education and exercise', 'Internet-based pain education and exercise intervention']","['pain intensity at post-treatment (8 weeks) measured using the 11-item Pain Numerical Rating Scale', 'chronic musculoskeletal pain condition', 'chronic musculoskeletal pain', 'pain and improving biopsychosocial outcomes']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0746683', 'cui_str': 'Chronic musculoskeletal pain'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C1862322', 'cui_str': 'Southeast Asian ovalocytosis'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}]","[{'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C3266592', 'cui_str': 'Pain education'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0746683', 'cui_str': 'Chronic musculoskeletal pain'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",160.0,0.196983,"Internet-based treatments have been shown to be an alternative for the treatment of musculoskeletal conditions, in addition to reducing barriers such as travel, high demands on the public health system, lack of time, lack of insurance coverage for private care, and high costs for long-term treatment.","[{'ForeName': 'Iuri', 'Initials': 'I', 'LastName': 'Fioratti', 'Affiliation': 'Masters and Doctoral Programs in Physical Therapy, Universidade Cidade de São Paulo, Rua Cesário Galeno, 448/475, Tatuape, São Paulo, 03071-000, Brazil.'}, {'ForeName': 'Bruno T', 'Initials': 'BT', 'LastName': 'Saragiotto', 'Affiliation': 'Masters and Doctoral Programs in Physical Therapy, Universidade Cidade de São Paulo, Rua Cesário Galeno, 448/475, Tatuape, São Paulo, 03071-000, Brazil. bruno.saragiotto@unicid.edu.br.'}, {'ForeName': 'Felipe J J', 'Initials': 'FJJ', 'LastName': 'Reis', 'Affiliation': 'Department of Physical Therapy, Instituto Federal do Rio de Janeiro, Rio de Janeiro, Brazil.'}, {'ForeName': 'Gisela C', 'Initials': 'GC', 'LastName': 'Miyamoto', 'Affiliation': 'Masters and Doctoral Programs in Physical Therapy, Universidade Cidade de São Paulo, Rua Cesário Galeno, 448/475, Tatuape, São Paulo, 03071-000, Brazil.'}, {'ForeName': 'Hopin', 'Initials': 'H', 'LastName': 'Lee', 'Affiliation': 'Centre for Statistics in Medicine, Rehabilitation Research in Oxford, Nuffield Department of Orthopaedics Rheumatology and Musculoskeletal Sciences (NDORMS), University of Oxford, Oxford, UK.'}, {'ForeName': 'Tiê P', 'Initials': 'TP', 'LastName': 'Yamato', 'Affiliation': 'Masters and Doctoral Programs in Physical Therapy, Universidade Cidade de São Paulo, Rua Cesário Galeno, 448/475, Tatuape, São Paulo, 03071-000, Brazil.'}, {'ForeName': 'Junior V', 'Initials': 'JV', 'LastName': 'Fandim', 'Affiliation': 'Masters and Doctoral Programs in Physical Therapy, Universidade Cidade de São Paulo, Rua Cesário Galeno, 448/475, Tatuape, São Paulo, 03071-000, Brazil.'}, {'ForeName': 'Blake', 'Initials': 'B', 'LastName': 'Dear', 'Affiliation': 'Department of Psychology, Macquarie University, Sydney, Australia.'}, {'ForeName': 'Chris G', 'Initials': 'CG', 'LastName': 'Maher', 'Affiliation': 'Institute for Musculoskeletal Health, The University of Sydney and Sydney Local Health District, Sydney, Australia.'}, {'ForeName': 'Leonardo O P', 'Initials': 'LOP', 'LastName': 'Costa', 'Affiliation': 'Masters and Doctoral Programs in Physical Therapy, Universidade Cidade de São Paulo, Rua Cesário Galeno, 448/475, Tatuape, São Paulo, 03071-000, Brazil.'}]",BMC musculoskeletal disorders,['10.1186/s12891-020-03423-x'] 2182,32591933,Can reminders improve adherence to regular physical activity and exercise recommendations in people over 60 years old? : A randomized controlled study.,"PURPOSE The purpose of the study was to investigate whether additional reminders could enhance adherence to a 12-week program consisting of regular physical activity. METHODS The study collective consisted of pensioners insured with the Austrian Insurance Fund for Civil or Public Servants. They were made aware of our program through the public service union. The subjects were randomized to an intervention group (group A) that received reminders and to a control group (group B) that did not receive such notifications. Adherence to physical activity was assessed by the use of diaries. RESULTS Group A performed 96 min more moderate intensity regular physical activity per week than group B (group A median 269 min, r = 0-1560 min; group B median 173 min, r = 0-2700 min). The Mann-Whitney U-test showed no significant differences (p = 0.080) between the study groups. There was no difference in muscle strengthening activity (group A: median: 2, r = 0-13 sessions; group B: median: 2, r = 0-20 sessions). CONCLUSION The major positive observation was that both the experimental and control group participants exceeded the recommended level of physical activity. Nevertheless, there were some differences concerning the minutes of physical activity performed in favor of the intervention group.",2020,"A performed 96 min more moderate intensity regular physical activity per week than group B (group A median 269 min, r = 0-1560 min; group B median 173 min, r = 0-2700 min).","['pensioners insured with the Austrian Insurance Fund for Civil or Public Servants', 'people over 60 years old']",['intervention group (group\xa0A) that received reminders and to a\xa0control group (group\xa0B) that did not receive such notifications'],"['muscle strengthening activity', 'moderate intensity regular physical activity', 'level of physical activity', 'Adherence to physical activity']","[{'cui': 'C0337795', 'cui_str': 'Austrians'}, {'cui': 'C0021672', 'cui_str': 'Insurance'}, {'cui': 'C0016820', 'cui_str': 'Funds'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0452260', 'cui_str': 'Muscular strength development exercise'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0422202', 'cui_str': 'Notifications'}]","[{'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}]",,0.0253331,"A performed 96 min more moderate intensity regular physical activity per week than group B (group A median 269 min, r = 0-1560 min; group B median 173 min, r = 0-2700 min).","[{'ForeName': 'Gudrun', 'Initials': 'G', 'LastName': 'Wolner-Strohmeyer', 'Affiliation': 'Wien Hauptstelle, Versicherungsanstalt öffentlich Bediensteter, Eisenbahnen und Bergbau, Vienna, Austria.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Keilani', 'Affiliation': 'Department of Physical Medicine, Rehabilitation and Occupational Medicine, Medical University of Vienna, Währinger Gürtel 18-20, 1090, Vienna, Austria.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Mähr', 'Affiliation': 'Therapiezentrum Rosalienhof, Versicherungsanstalt öffentlich Bediensteter, Eisenbahnen und Bergbau, Bad Tatzmannsdorf, Austria.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Morawetz', 'Affiliation': 'Wien Hauptstelle, Versicherungsanstalt öffentlich Bediensteter, Eisenbahnen und Bergbau, Vienna, Austria.'}, {'ForeName': 'Andrej', 'Initials': 'A', 'LastName': 'Zdravkovic', 'Affiliation': 'Department of Physical Medicine, Rehabilitation and Occupational Medicine, Medical University of Vienna, Währinger Gürtel 18-20, 1090, Vienna, Austria.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Wagner', 'Affiliation': 'Department of Physical Medicine, Rehabilitation and Occupational Medicine, Medical University of Vienna, Währinger Gürtel 18-20, 1090, Vienna, Austria.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Palma', 'Affiliation': 'Department of Physical Medicine, Rehabilitation and Occupational Medicine, Medical University of Vienna, Währinger Gürtel 18-20, 1090, Vienna, Austria.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Mickel', 'Affiliation': 'Department of Physical Medicine, Rehabilitation and Occupational Medicine, Medical University of Vienna, Währinger Gürtel 18-20, 1090, Vienna, Austria.'}, {'ForeName': 'Galateja', 'Initials': 'G', 'LastName': 'Jordakieva', 'Affiliation': 'Department of Physical Medicine, Rehabilitation and Occupational Medicine, Medical University of Vienna, Währinger Gürtel 18-20, 1090, Vienna, Austria.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Crevenna', 'Affiliation': 'Department of Physical Medicine, Rehabilitation and Occupational Medicine, Medical University of Vienna, Währinger Gürtel 18-20, 1090, Vienna, Austria. richard.crevenna@meduniwien.ac.at.'}]",Wiener klinische Wochenschrift,['10.1007/s00508-020-01699-6'] 2183,32592369,Neoadjuvant FOLFIRINOX followed by Chemoradiotherapy for Middle and Lower Rectal Cancer.,"OBJECTIVE Neoadjuvant concomitant chemoradiotherapy followed by surgical resection is the standard of care in the treatment of rectal cancer. We are investigating the value of adding combination chemotherapy oxaliplatin, irinotecan, leucovorin and fluorouracil (FOLFIRINOX) before neoadjuvant chemoradiotherapy. METHODS Forty-one patients with middle and lower rectal cancer were included. FOLFORINOX were given every 2 weeks over 2 months (4 cycles) followed by concomitant chemoradiotherapy (CRT). Surgery was done 6-8 weeks after CRT and then adjuvant 4 months of FOLFOX or XELOX were given. The primary end point was sphincter preservation rate. RESULTS All patients received the four cycles of neoadjuvant chemotherapy FOLFORINOX, 38 patients completed CRT and only 29 patients underwent surgery. 32 patients were available for assessment (29 patients who underwent surgery and three patients who refuse surgery because of no evidence of disease by endoscopy, imaging and biopsy). Sphincter preservation was achieved in twenty-one patients (51.2%). Pathological complete response rate was 24.1%. After a median follow up of 24 months. Median PFS was 20 months and 2-years PFS was 62.3%. The median overall survival of all patients was not reached, while 2-years OS was 76.5%. CONCLUSION Neoadjuvant FOLFIRINOX followed by CRT for middle and lower rectal cancer is feasible, tolerable with satisfactory sphincter preservation rate. 
.",2020,"The median overall survival of all patients was not reached, while 2-years OS was 76.5%. ","['38 patients completed CRT and only 29 patients underwent surgery', '32 patients were available for assessment (29 patients who underwent surgery and three patients who refuse surgery because of no evidence of disease by endoscopy, imaging and biopsy', 'Forty-one patients with middle and lower rectal cancer were included', 'Middle and Lower Rectal Cancer', 'rectal cancer']","['Neoadjuvant concomitant chemoradiotherapy', 'combination chemotherapy oxaliplatin, irinotecan, leucovorin and fluorouracil (FOLFIRINOX) before neoadjuvant chemoradiotherapy', 'FOLFOX or XELOX', 'concomitant chemoradiotherapy (CRT', 'neoadjuvant chemotherapy']","['Median PFS', 'Pathological complete response rate', 'sphincter preservation rate', 'median overall survival', 'Sphincter preservation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0470187', 'cui_str': 'Availability of'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0017095', 'cui_str': 'Trash'}, {'cui': 'C0332125', 'cui_str': 'No evidence of'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0227972', 'cui_str': 'Structure of median lobe of prostate'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0007113', 'cui_str': 'Rectal cancer'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C3178775', 'cui_str': 'Concomitant Radiochemotherapy'}, {'cui': 'C0013218', 'cui_str': 'Combination Drug Therapy'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0123931', 'cui_str': 'irinotecan'}, {'cui': 'C0023413', 'cui_str': 'Leucovorin'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C1956962', 'cui_str': 'XELOX'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",41.0,0.0860488,"The median overall survival of all patients was not reached, while 2-years OS was 76.5%. ","[{'ForeName': 'Amr', 'Initials': 'A', 'LastName': 'Sakr', 'Affiliation': 'Kasr Al-Ainy Center of Clinical Oncology and Nuclear Medicine (NEMROCK), Faculty of Medicine, Cairo University, Egypt.'}, {'ForeName': 'Mamdouh', 'Initials': 'M', 'LastName': 'Elsherbiny', 'Affiliation': 'Clinical Oncology Department, Faculty of Medicine, Beni Suef University, Egypt.'}, {'ForeName': 'Rabab', 'Initials': 'R', 'LastName': 'Abdel Moneim', 'Affiliation': 'Kasr Al-Ainy Center of Clinical Oncology and Nuclear Medicine (NEMROCK), Faculty of Medicine, Cairo University, Egypt.'}, {'ForeName': 'Saeed', 'Initials': 'S', 'LastName': 'Shaaban', 'Affiliation': 'Clinical Oncology Department, Faculty of Medicine, Beni Suef University, Egypt.'}, {'ForeName': 'Moustafa', 'Initials': 'M', 'LastName': 'Aldaly', 'Affiliation': 'Kasr Al-Ainy Center of Clinical Oncology and Nuclear Medicine (NEMROCK), Faculty of Medicine, Cairo University, Egypt.'}]",Asian Pacific journal of cancer prevention : APJCP,['10.31557/APJCP.2020.21.6.1717'] 2184,32592381,Randomized Pilot Study of 20 Gy in 5 Fractions versus 27 Gy in 3 Fractions Radiotherapy for Treating Painful Bone Metastases: A Single Institution Experience.,"PURPOSE Radiotherapy is a very effective tool in the treatment of painful bone metastases. The aim of this study was to compare the palliative effect of radiotherapy between the standard fractionation schedule 20 Gy over 5 fractions (20Gy/5fr) and the high biological dose schedule 27 Gy over 3 fractions (27Gy/3fr) which is frequently used in Stereotactic body radio-surgery (SBRT). METHODS Patients were randomized to receive (20Gy/5fr)or (27Gy/3fr). The primary aim of the study was pain relief using the numeric rating scale (NRS), after three months of radiation therapy. Secondary end points include pain relief immediately after finishing radiation therapy (within one week), and narcotic relief after three months of radiation therapy. RESULTS Twenty-two patients with painful bone metastases were included. 12 patients received (20Gy/5fr) and 10 patients received (27Gy/3fr). Male patients were predominant on both arms (81.8%) with a mean age of 58 years [ranging between 19-72 years]. For pain relief after three months of radiation therapy, partial pain relief was documented in 9 patients (75%) with (20Gy/5fr) and in 8 patients (80%) with (27Gy/3fr) with a p- value of 0.6. Additionally, narcotic relief after three months was equal for both groups. For immediate pain relief, partial pain relief was seen in one patient (8%) with (20Gy/5fr) versus seven patients (70%) with (27Gy/3fr) with a p value of 0.06. The increase in immediate pain relief in the 27Gy arm was numerically but not statistically significant. CONCLUSION SBRT and standard fractionation radiation therapy had equal effectiveness for pain relief, when the assessment was done after three months of radiation therapy. Interestingly, SBRT had a better immediate pain relief. 
.",2020,"The increase in immediate pain relief in the 27Gy arm was numerically but not statistically significant. ","['Male patients were predominant on both arms (81.8%) with a mean age of 58 years [ranging between 19-72 years', '12 patients received (20Gy/5fr) and 10 patients received (27Gy/3fr', 'painful bone metastases', 'Twenty-two patients with painful bone metastases', 'Patients were randomized to receive (20Gy/5fr)or (27Gy/3fr']","['radiotherapy', '20 Gy in 5 Fractions versus 27 Gy in 3 Fractions Radiotherapy', 'SBRT and standard fractionation radiation therapy', 'SBRT', 'Radiotherapy']","['partial pain relief', 'pain relief', 'immediate pain relief', 'pain relief using the numeric rating scale (NRS', 'narcotic relief', 'immediate pain relief, partial pain relief']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0230348', 'cui_str': 'Both upper arms'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0153690', 'cui_str': 'Secondary malignant neoplasm of bone'}, {'cui': 'C4284772', 'cui_str': '22'}]","[{'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0524811', 'cui_str': 'Dose Fractionation, Radiotherapy'}]","[{'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0027415', 'cui_str': 'Narcotic'}, {'cui': 'C0564405', 'cui_str': 'Feeling relief'}]",22.0,0.0383319,"The increase in immediate pain relief in the 27Gy arm was numerically but not statistically significant. ","[{'ForeName': 'Amr', 'Initials': 'A', 'LastName': 'Sakr', 'Affiliation': 'Department of Clinical Oncology, Kasr Al-Einy School of Medicine, Cairo University, Egypt.'}, {'ForeName': 'Wedad Bassam', 'Initials': 'WB', 'LastName': 'Hashem', 'Affiliation': 'Department of Clinical Oncology, Kasr Al-Einy School of Medicine, Cairo University, Egypt.'}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Ebrahim', 'Affiliation': 'Department of Clinical Oncology, Kasr Al-Einy School of Medicine, Cairo University, Egypt.'}, {'ForeName': 'Karim Nabil', 'Initials': 'KN', 'LastName': 'Mashhour', 'Affiliation': 'Department of Clinical Oncology, Kasr Al-Einy School of Medicine, Cairo University, Egypt.'}]",Asian Pacific journal of cancer prevention : APJCP,['10.31557/APJCP.2020.21.6.1807'] 2185,32592382,Effect of a Pedometer-based Exercise Program on Cancer Related Fatigue and Quality of Life amongst Patients with Breast Cancer Receiving Chemotherapy.,"BACKGROUND Breast cancer is the most common cancer amongst Indian women. Cancer treatments leads to various side effects out of which Cancer-Related fatigue (CRF) is one of the most under-addressed side-effects. It is experienced the most in patients receiving chemotherapy. Exercise has been proven to be a beneficial intervention to manage CRF but the benefits of pedometer-based exercise programs is under-studied in patients with breast cancer. Hence, we set out to investigate the effects of a pedometer-based exercise program for patients with breast receiving chemotherapy. METHODS The current study was a non-randomized controlled trial with 22 patients each in exercise and control group. The exercise group received a pedometer-based walking program, whereas the control group received standard physical activity advice. Fatigue, quality of life, functional capacity and body composition were assessed at baseline, 3rd week and 7th week. RESULTS At the end of 7 weeks intervention, functional capacity, quality of life and skeletal mass were found to have improved with statistical significance, while the fatigue and changes in total fat did improve but were not statistically significant. CONCLUSION A 7-week pedometer-based exercise program improved functional capacity, quality of life and percentage of skeletal mass and also shows to have prevented deterioration in fatigue levels in patients with breast cancer receiving chemotherapy.",2020,"A 7-week pedometer-based exercise program improved functional capacity, quality of life and percentage of skeletal mass and also shows to have prevented deterioration in fatigue levels in patients with breast cancer receiving chemotherapy.","['patients with breast receiving chemotherapy', 'Indian women', 'Patients with Breast Cancer', '22 patients each in exercise and control group', 'patients with breast cancer', 'patients receiving chemotherapy', 'patients with breast cancer receiving chemotherapy']","['pedometer-based walking program, whereas the control group received standard physical activity advice', 'Pedometer-based Exercise Program', 'Chemotherapy', 'pedometer-based exercise program']","['Cancer Related Fatigue and Quality of Life', 'Fatigue, quality of life, functional capacity and body composition', 'functional capacity, quality of life and skeletal mass', 'functional capacity, quality of life and percentage of skeletal mass', 'fatigue and changes in total fat']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0002460', 'cui_str': 'American Indian race'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C4274302', 'cui_str': 'Cancer-related fatigue'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0037253', 'cui_str': 'Skeletal system structure'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0015677', 'cui_str': 'Fat'}]",22.0,0.0245141,"A 7-week pedometer-based exercise program improved functional capacity, quality of life and percentage of skeletal mass and also shows to have prevented deterioration in fatigue levels in patients with breast cancer receiving chemotherapy.","[{'ForeName': 'Aagna', 'Initials': 'A', 'LastName': 'Gandhi', 'Affiliation': 'Department of Physiotherapy, Kasturba Medical College, Mangalore, Manipal Academy of Higher Education, India.'}, {'ForeName': 'Stephen Rajan', 'Initials': 'SR', 'LastName': 'Samuel', 'Affiliation': 'Department of Physiotherapy, Kasturba Medical College, Mangalore, Manipal Academy of Higher Education, India.'}, {'ForeName': 'K Vijaya', 'Initials': 'KV', 'LastName': 'Kumar', 'Affiliation': 'Department of Physiotherapy, Kasturba Medical College, Mangalore, Manipal Academy of Higher Education, India.'}, {'ForeName': 'Pu Prakash', 'Initials': 'PP', 'LastName': 'Saxena', 'Affiliation': 'Department of Radiation oncology, Kasturba Medical College, Manipal Academy of Higher education, Mangalore, India.'}, {'ForeName': 'Prasanna', 'Initials': 'P', 'LastName': 'Mithra', 'Affiliation': 'Department of Community Medicine, Kasturba Medical College, Mangalore, Manipal Academy of Higher Education, Manipal, India.'}]",Asian Pacific journal of cancer prevention : APJCP,['10.31557/APJCP.2020.21.6.1813'] 2186,32595900,Comparison of apical sealing ability of bioceramic sealer and epoxy resin-based sealer using the fluid filtration technique and scanning electron microscopy.,"Background/purpose A perfect sealing of root canal system is essential for preventing ingress of bacteria from the oral environment. The purpose of this study was to evaluate the apical sealing ability of bioceramic (EndoSequence BC Sealer®) and epoxy resin-based (AH Plus®) sealers at 24 h, 7 days and 4 weeks. Materials and methods Forty two extracted human upper anterior teeth were sectioned to leave the root 15-mm long, then all the roots were instrumented using a set of ProTaper® rotary instruments. Four roots were selected randomly as controls, and the remaining 38 roots were randomly divided into 2 groups of 19 roots each: group 1: EndoSequence BC Sealer® and gutta-percha, and group 2: AH Plus® and gutta-percha using a multiple wave condensation technique. The apical sealing ability of the filled root canal was measured using the fluid filtration method with 200 mmHg (26.67 KPa) above atmospheric pressure at 24 h, 7 days and 4 weeks. Scanning electron microscopy (SEM) was used to assess the adaptation and penetration of the sealers. The apical microleakage between 2 groups was compared using Student's t-test. P  < 0.05 was considered statistically significant. Results EndoSequence BC Sealer® had significantly better sealing ability than AH Plus® at all test periods ( P  < 0.001). SEM showed EndoSequence BC Sealer® had better penetration into dentinal tubules. Conclusion Bioceramic sealer could promote proper sealing of root canals obturated with multiple wave condensation.",2020,"Results EndoSequence BC Sealer® had significantly better sealing ability than AH Plus® at all test periods ( P  < 0.001).","['Four roots were selected randomly as controls, and the remaining 38 roots', 'Materials and methods\n\n\nForty two extracted human upper anterior teeth']","['bioceramic sealer and epoxy resin-based sealer', 'bioceramic (EndoSequence BC Sealer®) and epoxy resin-based (AH Plus®) sealers', 'Scanning electron microscopy (SEM', 'EndoSequence BC Sealer® and gutta-percha, and group 2: AH Plus® and gutta-percha using a multiple wave condensation technique']","['sealing ability', 'apical microleakage']","[{'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4319566', 'cui_str': '42'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0441999', 'cui_str': 'Upper anterior'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}]","[{'cui': 'C0449942', 'cui_str': 'Sealer'}, {'cui': 'C0014631', 'cui_str': 'Epoxy resin'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0673096', 'cui_str': 'AH Plus'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0026019', 'cui_str': 'Electron microscopic study'}, {'cui': 'C0018407', 'cui_str': 'Gutta percha'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0233656', 'cui_str': 'Mental condensation'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0036492', 'cui_str': 'Seal'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0205111', 'cui_str': 'Apical'}]",4.0,0.0271394,"Results EndoSequence BC Sealer® had significantly better sealing ability than AH Plus® at all test periods ( P  < 0.001).","[{'ForeName': 'Widcha', 'Initials': 'W', 'LastName': 'Asawaworarit', 'Affiliation': 'Department of Endodontics, Faculty of Dentistry, Western University, Hathairaj Road, Lumlukka, Pathumthani, 12150, Thailand.'}, {'ForeName': 'Thitapa', 'Initials': 'T', 'LastName': 'Pinyosopon', 'Affiliation': 'Nakhon Nayok Hospital, Ban Yai, Muang Nakhon Nayok, Nakhon Nayok, 26000, Thailand.'}, {'ForeName': 'Kanittha', 'Initials': 'K', 'LastName': 'Kijsamanmith', 'Affiliation': 'Department of Oral Biology, Faculty of Dentistry, Mahidol University, Yothi Street, Ratchathewi, Bangkok, 10400, Thailand.'}]",Journal of dental sciences,['10.1016/j.jds.2019.09.010'] 2187,32595918,"Effect of whole soy and isoflavones daidzein on bone turnover and inflammatory markers: a 6-month double-blind, randomized controlled trial in Chinese postmenopausal women who are equol producers.","Background Human studies have demonstrated the beneficial effects of soy or isoflavones on bone metabolism. However, conflicting data remain. Equol is the intestinal metabolite of the isoflavone daidzein. The health benefits of soy are more pronounced in equol producers than those not producing equol. This 6-month randomized controlled trial aimed to examine the effect of whole soy (soy flour) and purified daidzein on bone turnover markers (BTMs) in Chinese postmenopausal women who are equol producers. Methods A total of 270 eligible women were randomized to either one of the three isocaloric supplements as follows: 40 g soy flour (whole soy group), 40 g low-fat milk powder + 63 mg daidzein (daidzein group), or 40 g low-fat milk powder (placebo group) given as a solid beverage daily for 6 months. The following fasting venous samples were collected at the baseline and end of the trial to analyze BTMs: serum cross-linked C-telopeptides of type I collagen, bone-specific alkaline phosphatase, osteocalcin, procollagen type I N-terminal propeptide, and 25(OH)D 3 . Inflammation-related biomarkers, such as serum interleukin-6, tumor necrosis factor-alpha, C-reactive protein, transferrin, and homocysteine, were also tested to explore potential mechanisms. Results A total of 253 subjects validly completed the study protocol. Urinary isoflavones suggested a good compliance to the treatments. Intention-to-treat and per-protocol analyses indicated no significant difference in the 6-month or percentage changes in the parameters of bone metabolism and inflammatory markers among the three treatment groups. Conclusions Whole soy and purified daidzein at provided dosages exhibited no significant effect on the bone metabolism and inflammation levels among Chinese equol-producing postmenopausal women. Trial registration ClinicalTrials.gov identifier NCT01270737.",2020,"Inflammation-related biomarkers, such as serum interleukin-6, tumor necrosis factor-alpha, C-reactive protein, transferrin, and homocysteine, were also tested to explore potential mechanisms. ","['253 subjects validly completed the study protocol', 'Chinese postmenopausal women who are equol producers', 'Chinese equol-producing postmenopausal women', '270 eligible women']","['Equol', 'whole soy (soy flour) and purified daidzein', 'whole soy and isoflavones daidzein', 'isoflavone daidzein', 'Whole soy and purified daidzein', 'soy flour (whole soy group), 40\u2009g low-fat milk powder\u2009+\u200963\u2009mg daidzein (daidzein group), or 40\u2009g low-fat milk powder (placebo group) given as a solid beverage daily for 6\u2009months', 'soy or isoflavones']","['bone metabolism and inflammatory markers', 'bone metabolism and inflammation levels', 'bone turnover and inflammatory markers', 'bone metabolism', 'bone turnover markers (BTMs']","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C2599718', 'cui_str': 'Clinical Trial Protocols'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0059497', 'cui_str': 'Equol'}, {'cui': 'C4319603', 'cui_str': '270'}]","[{'cui': 'C0059497', 'cui_str': 'Equol'}, {'cui': 'C0037733', 'cui_str': 'Soya bean'}, {'cui': 'C0771806', 'cui_str': 'Soya flour'}, {'cui': 'C0057090', 'cui_str': 'daidzein'}, {'cui': 'C0022179', 'cui_str': 'Isoflavone Derivatives'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0349375', 'cui_str': 'Skim milk'}, {'cui': 'C0032861', 'cui_str': 'Powder'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0205208', 'cui_str': 'Solid'}, {'cui': 'C0001967', 'cui_str': 'Alcoholic beverage'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0085268', 'cui_str': 'Bone remodeling'}]",270.0,0.31615,"Inflammation-related biomarkers, such as serum interleukin-6, tumor necrosis factor-alpha, C-reactive protein, transferrin, and homocysteine, were also tested to explore potential mechanisms. ","[{'ForeName': 'Zhao-Min', 'Initials': 'ZM', 'LastName': 'Liu', 'Affiliation': 'Department of Nutrition, School of Public Health, Sun Yat-sen University (North Campus), Guangzhou, Guangdong, PR China.'}, {'ForeName': 'Bailing', 'Initials': 'B', 'LastName': 'Chen', 'Affiliation': 'Department of Spine Surgery, the First Affiliated Hospital of Sun Yet-sen University, Guangzhou, Guangdong, PR China.'}, {'ForeName': 'Shuyi', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'Department of Nutrition, School of Public Health, Sun Yat-sen University (North Campus), Guangzhou, Guangdong, PR China.'}, {'ForeName': 'Guoyi', 'Initials': 'G', 'LastName': 'Li', 'Affiliation': 'Department of Nutrition, School of Public Health, Sun Yat-sen University (North Campus), Guangzhou, Guangdong, PR China.'}, {'ForeName': 'Di', 'Initials': 'D', 'LastName': 'Zhang', 'Affiliation': 'Department of Nutrition, School of Public Health, Sun Yat-sen University (North Campus), Guangzhou, Guangdong, PR China.'}, {'ForeName': 'Suzanne C', 'Initials': 'SC', 'LastName': 'Ho', 'Affiliation': 'Department of Epidemiology, Jockey Club School of Public Health and Primary Care, the Chinese University of Hong Kong, New Territories, Hong Kong.'}, {'ForeName': 'Yu-Ming', 'Initials': 'YM', 'LastName': 'Chen', 'Affiliation': 'Department of Nutrition, School of Public Health, Sun Yat-sen University (North Campus), Guangzhou, Guangdong, PR China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Ma', 'Affiliation': 'Department of Nutrition, School of Public Health, Sun Yat-sen University (North Campus), Guangzhou, Guangdong, PR China.'}, {'ForeName': 'Huang', 'Initials': 'H', 'LastName': 'Qi', 'Affiliation': 'Department of Nutrition, School of Public Health, Sun Yat-sen University (North Campus), Guangzhou, Guangdong, PR China.'}, {'ForeName': 'Wen-Hua', 'Initials': 'WH', 'LastName': 'Ling', 'Affiliation': 'Department of Nutrition, School of Public Health, Sun Yat-sen University (North Campus), Guangzhou, Guangdong, PR China.'}]",Therapeutic advances in endocrinology and metabolism,['10.1177/2042018820920555'] 2188,32595959,The effects of a temporal processing-based auditory training program on the auditory skills of elderly users of hearing aids: a study protocol for a randomized clinical trial.,"Background : One of the most important effects of age-related declines in neural processing speed is the impairment of temporal resolution, which leads to difficulty hearing in noisy environments. Since the central auditory system is highly plastic, by designing and implementing a temporal processing-based auditory training program, we can help the elderly improve their listening skills and speech understanding in noisy environments. Methods: In the first phase of this research, based on the theoretical framework of temporal processing, an auditory training solution was developed as a software program. In the second phase, which will be described in the present study, the effects of the designed program on the listening skills of the elderly users of hearing aids (age: 60-75 years) will be studied in the control and intervention groups. In the intervention group, the auditory training program will be implemented for three months (36 sessions), and the results of central tests (GIN, DPT, QuickSIN) and the electrophysiological speech-ABR test will be compared in both groups before, immediately and one month after the intervention. Discussion : Since temporal processing is not sufficient in auditory training programs for the elderly with hearing impairments, implementation of a temporal processing-based auditory training program can reduce hearing problems in noisy environments among elderly users of hearing aids. Trial registration: This study was registered as a clinical trial in the Iranian Registry of Clinical Trials ( IRCT20190921044838N1) on December 25, 2019.",2020,"In the first phase of this research, based on the theoretical framework of temporal processing, an auditory training solution was developed as a software program.","['elderly users of hearing aids (age: 60-75 years', 'elderly users of hearing aids', 'elderly with hearing impairments']","[' ', 'temporal processing-based auditory training program', 'auditory training program']",['auditory skills'],"[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0018768', 'cui_str': 'Hearing aid'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0018767', 'cui_str': 'Hearing'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}]","[{'cui': 'C0442043', 'cui_str': 'Temporal'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0439825', 'cui_str': 'Auditory'}]",,0.027288,"In the first phase of this research, based on the theoretical framework of temporal processing, an auditory training solution was developed as a software program.","[{'ForeName': 'Nariman', 'Initials': 'N', 'LastName': 'Rahbar', 'Affiliation': 'Department of Audiology, Rehabilitation Research Center, School of Rehabilitation Sciences, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Karim', 'Initials': 'K', 'LastName': 'Sattari', 'Affiliation': 'Department of Audiology, Rehabilitation Research Center, School of Rehabilitation Sciences, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohsen', 'Initials': 'M', 'LastName': 'Ahadi', 'Affiliation': 'Department of Audiology, Rehabilitation Research Center, School of Rehabilitation Sciences, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hamid', 'Initials': 'H', 'LastName': 'Haghani', 'Affiliation': 'Department of Biostatistics, School of Management and Information Technology, Iran University of Medical Sciences, Tehran, Iran.'}]",F1000Research,['10.12688/f1000research.22757.1'] 2189,32595978,A feasibility investigation of mindfulness-based cognitive therapy for people with Huntington's disease.,"Background Huntington's disease (HD) is an inherited neurodegenerative condition which affects movement, coordination and cognitive functioning. Psychological difficulties are commonly experienced; however, psychological interventions have been little researched with this population. We investigated the feasibility of conducting a randomised controlled trial (RCT) of mindfulness-based cognitive therapy (MBCT) with people with the HD genetic mutation, either pre-manifest (before onset of movement symptoms) or at an early disease stage. Specifically, we evaluated the willingness of participants to be recruited into and complete the intervention; the acceptability of the study measures in relation to completion; the feasibility of offering the standard MBCT course to people with HD; the acceptability of the intervention and the estimated effect sizes. Methods Participants were recruited from two UK HD centres and took part in an 8-week course of MBCT, with three reunions throughout the following year. Stress, depression, anxiety, and mindfulness were measured pre-, mid-, and post-course, at 3 months and at 1 year. Sleep, quality of life, positive affect and coping were measured pre- and post-course, at 3 months and at 1 year. Descriptive data and approximate effect sizes were calculated. Interviews were conducted post-course and at 1 year and data pertaining to the acceptability of the course were extracted. Results Twelve participants took part in two groups; all were pre-manifest. Levels of depression and anxiety were low pre-course leaving little room for improvement. Changes in stress and in some aspects of mindfulness were medium to large. The qualitative data suggested participants rated the course highly and found it helpful and no changes to the standard course were needed. Recruitment levels were below those anticipated. Most measures were found to be acceptable. Conclusions Although the course was acceptable to those who took part, given the difficulties in recruiting and the rarity of HD, conducting an RCT of MBCT teaching groups in person does not seem feasible. However, alternative modes of course delivery (e.g. online) would allow the recruitment of people from a greater geographical area and may make an RCT feasible; this revised focus would be suitable for future feasibility studies. Trial registration ClinicalTrials.gov identifier NCT02464293, registered 8 June 2015.",2020,Changes in stress and in some aspects of mindfulness were medium to large.,"['people with the HD genetic mutation, either pre-manifest (before onset of movement symptoms) or at an early disease stage', 'Methods\n\n\nParticipants were recruited from two UK HD centres and took part in an 8-week course of MBCT, with three reunions throughout the following year', ""people with Huntington's disease""]","['mindfulness-based cognitive therapy', 'mindfulness-based cognitive therapy (MBCT']","['Sleep, quality of life, positive affect and coping', 'Levels of depression and anxiety', 'Stress, depression, anxiety, and mindfulness']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0020179', 'cui_str': ""Huntington's chorea""}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0205319', 'cui_str': 'Manifest'}, {'cui': 'C0332162', 'cui_str': 'Onset of'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0035373', 'cui_str': 'Reunion'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C1319226', 'cui_str': 'Level of depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}]",12.0,0.0544727,Changes in stress and in some aspects of mindfulness were medium to large.,"[{'ForeName': 'Fiona J R', 'Initials': 'FJR', 'LastName': 'Eccles', 'Affiliation': 'Division of Health Research, Faculty of Health and Medicine, Lancaster University, Lancaster, LA1 4YT UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Craufurd', 'Affiliation': 'Division of Evolution and Genomic Sciences, School of Biological Sciences, Faculty of Biology, Medicine and Health, Manchester Academic Health Science Centre, University of Manchester, Manchester, M13 9PL UK.'}, {'ForeName': 'Alistair', 'Initials': 'A', 'LastName': 'Smith', 'Affiliation': 'Division of Health Research, Faculty of Health and Medicine, Lancaster University, Lancaster, LA1 4YT UK.'}, {'ForeName': 'Rhys', 'Initials': 'R', 'LastName': 'Davies', 'Affiliation': 'The Walton Centre NHS Foundation Trust, Lower Lane, Fazakerley, Liverpool, L9 7LJ UK.'}, {'ForeName': 'Kristian', 'Initials': 'K', 'LastName': 'Glenny', 'Affiliation': 'Division of Health Research, Faculty of Health and Medicine, Lancaster University, Lancaster, LA1 4YT UK.'}, {'ForeName': 'Max', 'Initials': 'M', 'LastName': 'Homberger', 'Affiliation': 'Division of Health Research, Faculty of Health and Medicine, Lancaster University, Lancaster, LA1 4YT UK.'}, {'ForeName': 'Siofra', 'Initials': 'S', 'LastName': 'Peeren', 'Affiliation': 'Division of Evolution and Genomic Sciences, School of Biological Sciences, Faculty of Biology, Medicine and Health, Manchester Academic Health Science Centre, University of Manchester, Manchester, M13 9PL UK.'}, {'ForeName': 'Dawn', 'Initials': 'D', 'LastName': 'Rogers', 'Affiliation': 'Division of Evolution and Genomic Sciences, School of Biological Sciences, Faculty of Biology, Medicine and Health, Manchester Academic Health Science Centre, University of Manchester, Manchester, M13 9PL UK.'}, {'ForeName': 'Leona', 'Initials': 'L', 'LastName': 'Rose', 'Affiliation': 'Division of Health Research, Faculty of Health and Medicine, Lancaster University, Lancaster, LA1 4YT UK.'}, {'ForeName': 'Zara', 'Initials': 'Z', 'LastName': 'Skitt', 'Affiliation': 'Division of Evolution and Genomic Sciences, School of Biological Sciences, Faculty of Biology, Medicine and Health, Manchester Academic Health Science Centre, University of Manchester, Manchester, M13 9PL UK.'}, {'ForeName': 'Rachael', 'Initials': 'R', 'LastName': 'Theed', 'Affiliation': 'Division of Health Research, Faculty of Health and Medicine, Lancaster University, Lancaster, LA1 4YT UK.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Simpson', 'Affiliation': 'Division of Health Research, Faculty of Health and Medicine, Lancaster University, Lancaster, LA1 4YT UK.'}]",Pilot and feasibility studies,['10.1186/s40814-020-00631-z'] 2190,32596251,"A Hydrogel Drink With High Fructose Content Generates Higher Exogenous Carbohydrate Oxidation and Lower Dental Biofilm pH Compared to Two Other, Commercially Available, Carbohydrate Sports Drinks.","The purpose of this study was to evaluate the substrate oxidation of three commercially available, 14%-carbohydrate sports drinks with different compositions, osmolality, and pH for their impact on dental exposure to low pH. In a cross-over, randomized double-blinded design, 12 endurance athletes (age 31. 2 ± 7.7 years, V ˙ O 2max 65.6 ± 5.0 mL·kg -1 ) completed 180 min of cycling at 55% W max . During the first 100 min of cycling, athletes consumed amylopectin starch (AP), maltodextrin+sucrose (MD+SUC), or maltodextrin+fructose hydrogel (MD+FRU) drinks providing 95 g carbohydrate·h -1 , followed by water intake only at 120 and 160 min. Fuel use was determined using indirect calorimetry and stable-isotope techniques. Additionally, dental biofilm pH was measured using the microtouch method in a subsample of participants ( n = 6) during resting conditions before, and at different time intervals up to 45 min following a single bolus of drink. Exogenous carbohydrate oxidation (CHO EXO ) during the 2nd hour of exercise was significantly ( P < 0.05) different between all three drinks: MD+FRU (1.17 ± 0.17 g·min -1 ), MD+SUC (1.01 ± 0.13 g·min -1 ), and AP (0.84 ± 0.11 g·min -1 ). At the end of exercise, CHO EXO and blood glucose concentrations (3.54 ± 0.50, 4.07 ± 0.67, and 4.28 ± 0.47 mmol·L -1 , respectively) were significantly lower post MD+FRU consumption than post MD+SUC and AP consumption ( P < 0.05). Biofilm acidogenicity at rest demonstrated a less pronounced pH fall for MD+FRU compared to the acidulant-containing MD+SUC and AP ( P < 0.05). In conclusion, while total intake of MD+FRU showed signs of completed uptake before end of monitoring, this was less so for MD+SUC, and not at all the case for AP. Thus, this study showed that despite carbohydrates being encapsulated in a hydrogel, a higher CHO EXO was observed following MD+FRU drink ingestion compared to AP and MD+SUC consumption upon exposure to the acidic environment of the stomach. This finding may be related to the higher fructose content of the MD+FRU drink compared with the MD+SUC and AP drinks. Furthermore, a carbohydrate solution without added acidulants, which are commonly included in commercial sport drinks, may have less deleterious effects on oral health.",2020,"Exogenous carbohydrate oxidation (CHO EXO ) during the 2nd hour of exercise was significantly ( P < 0.05) different between all three drinks: MD+FRU (1.17 ± 0.17 g·min -1 ), MD+SUC (1.01 ± 0.13 g·min -1 ), and AP (0.84 ± 0.11 g·min -1 ).","['dental exposure to low pH', '2 ± 7.7 years, V ˙', '12 endurance athletes (age 31']","['Hydrogel Drink With High Fructose Content', 'amylopectin starch (AP), maltodextrin+sucrose (MD+SUC), or maltodextrin+fructose hydrogel (MD+FRU) drinks']","['Biofilm acidogenicity', 'CHO EXO and blood glucose concentrations', 'Exogenous Carbohydrate Oxidation and Lower Dental Biofilm pH', 'pH fall for MD+FRU', 'substrate oxidation', 'dental biofilm pH', 'Exogenous carbohydrate oxidation (CHO EXO ']","[{'cui': 'C0011365', 'cui_str': 'Health Services, Dental'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0728725', 'cui_str': 'Low pH'}, {'cui': 'C4517860', 'cui_str': '7.7'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0063083', 'cui_str': 'Hydrogel'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0016745', 'cui_str': 'Fructose'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0002728', 'cui_str': 'Amylopectin'}, {'cui': 'C0038179', 'cui_str': 'Starch'}]","[{'cui': 'C0081786', 'cui_str': 'Biofilm'}, {'cui': 'C0054889', 'cui_str': 'CAV protocol'}, {'cui': 'C2585282', 'cui_str': 'Blood glucose concentration'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0011365', 'cui_str': 'Health Services, Dental'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}]",12.0,0.0885326,"Exogenous carbohydrate oxidation (CHO EXO ) during the 2nd hour of exercise was significantly ( P < 0.05) different between all three drinks: MD+FRU (1.17 ± 0.17 g·min -1 ), MD+SUC (1.01 ± 0.13 g·min -1 ), and AP (0.84 ± 0.11 g·min -1 ).","[{'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Pettersson', 'Affiliation': 'Department of Food and Nutrition, and Sport Science, Center for Health and Performance, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Ahnoff', 'Affiliation': 'Maurten AB, Research and Development, Gothenburg, Sweden.'}, {'ForeName': 'Fredrik', 'Initials': 'F', 'LastName': 'Edin', 'Affiliation': 'Department of Food and Nutrition, and Sport Science, Center for Health and Performance, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Lingström', 'Affiliation': 'Department of Cariology, Institute of Odontology, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Simark Mattsson', 'Affiliation': 'Department of Cariology, Institute of Odontology, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}, {'ForeName': 'Ulrika', 'Initials': 'U', 'LastName': 'Andersson-Hall', 'Affiliation': 'Department of Physiology, Institute of Neuroscience and Physiology, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.'}]",Frontiers in nutrition,['10.3389/fnut.2020.00088'] 2191,32596252,Does the Sentinel Lymph Node Sampling Alone Improve Quality of Life in Early Cervical Cancer Management?,"Objective: In this subanalysis of the prospective randomized multicenter SENTICOL 2 study, we compared the quality of life (QoL), in two arms, in association with lower-limb consequences in women with early stage cervical cancer undergoing randomized sentinel lymph node (SLN) sampling alone or SLN sampling and full pelvic lymphadenectomy. Methods: 206 patients with an early stage cervical cancer and a negative SLN, were randomized. Every patient had a SLN detection based on a combination of radio-isotope (Nanocis®) and blue dye (Bleu Patenté®) injections. One hundred and One patients, the ""standard"" group, had complete pelvic lymphadenectomy, 105 patients, the ""SLN alone"" group, had SLN biopsy without lymphadenectomy. At each visit (V0: preoperative, V1: 1 month, V2: 3 months and V3: 6 months following surgery) the patients completed a Short Form Health Survey (SF36) questionnaire and another questionnaire related to leg lymphedema. SF36 scores variations (compared to the baseline values) were assessed with a standard analysis and by an evaluation of the area under the curve (AUC). Several lower-limb circumferences and signs were also determined. Results: General characteristics of the patients were well-balanced between groups. Physical function and general health dimensions of the SF36 scale were significantly improved at V1 and V2 in the ""SLN alone"" group. Mental health was also statistically better in the ""SLN alone"" group at V2. Other dimensions were similar. The two groups had similar evaluation at V3. AUC of SF36 sub-scores was also in favor of the ""SLN alone"" arm, but the difference was not statistically significant. The analysis about the lymphedema of the legs showed a reduced (but not significant) risk in the ""SLN alone"" group for the top-of-thigh and the mid-thigh perimeters. Lymphedema symptoms reported by the patients were significantly less severe in the ""SLN alone"" group. Conclusion: Our study demonstrates a trend for a better quality of life and less severe leg heaviness and leg fatigue when a full pelvic lymphadenectomy is avoided.",2020,"Physical function and general health dimensions of the SF36 scale were significantly improved at V1 and V2 in the ""SLN alone"" group.","['206 patients with an early stage cervical cancer and a negative SLN', 'women with early stage cervical cancer undergoing randomized', 'One hundred and One patients, the ""standard"" group, had complete pelvic lymphadenectomy, 105 patients, the ""SLN alone"" group, had SLN biopsy without lymphadenectomy']","['radio-isotope (Nanocis®) and blue dye (Bleu Patenté®) injections', 'sentinel lymph node (SLN) sampling alone or SLN sampling and full pelvic lymphadenectomy']","['quality of life (QoL', 'Physical function and general health dimensions of the SF36 scale', 'SF36 scores variations', 'Quality of Life', 'AUC of SF36 sub-scores', 'Lymphedema symptoms', 'Mental health', 'Short Form Health Survey (SF36) questionnaire and another questionnaire related to leg lymphedema']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C1522495', 'cui_str': 'Sentinal Node'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0193883', 'cui_str': 'Pelvic lymphadenectomy'}, {'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0024203', 'cui_str': 'Excision of lymph node'}]","[{'cui': 'C0034546', 'cui_str': 'Radio'}, {'cui': 'C0022262', 'cui_str': 'Isotope'}, {'cui': 'C1741339', 'cui_str': 'nanocis'}, {'cui': 'C1260957', 'cui_str': 'Blue color'}, {'cui': 'C0013343', 'cui_str': 'Dye'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0677944', 'cui_str': 'Sentinel node'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C1522495', 'cui_str': 'Sentinal Node'}, {'cui': 'C0193883', 'cui_str': 'Pelvic lymphadenectomy'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0424575', 'cui_str': 'General body state finding'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0042333', 'cui_str': 'Genetic variation'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0024236', 'cui_str': 'Lymphedema'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}]",206.0,0.0502377,"Physical function and general health dimensions of the SF36 scale were significantly improved at V1 and V2 in the ""SLN alone"" group.","[{'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Gianoni', 'Affiliation': 'UNIL et Service de Gynécologie, CHUV, Lausanne, Switzerland.'}, {'ForeName': 'Patrice', 'Initials': 'P', 'LastName': 'Mathevet', 'Affiliation': 'UNIL et Service de Gynécologie, CHUV, Lausanne, Switzerland.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Uzan', 'Affiliation': 'Service de chirurgie gynécologique, Institut Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Anne Sophie', 'Initials': 'AS', 'LastName': 'Bats', 'Affiliation': 'Service de Chirurgie Gynécologique, Hôpital Européen Georges Pompidou, Paris, France.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Magaud', 'Affiliation': 'Hospices Civils de Lyon, Pôle Santé Publique, Service Recherche et épidémiologie Cliniques, Lyon, France.'}, {'ForeName': 'Florent', 'Initials': 'F', 'LastName': 'Boutitie', 'Affiliation': 'Service de Biostatistiques, Batiment 4D, CHLS, Ch. Du Grand Revoyet, Pierre-Bénite, France.'}, {'ForeName': 'Fabrice', 'Initials': 'F', 'LastName': 'Lécuru', 'Affiliation': 'Service de chirurgie et cancérologie gynécologique et mammaire, Institut Curie, Paris, France.'}]",Frontiers in surgery,['10.3389/fsurg.2020.00031'] 2192,32596297,Different Development Forms of Local Allergic Rhinitis towards Birch.,"Background Efficacy of allergen immunotherapy (AIT) in local allergic rhinitis (LAR) is a new subject of research. The presence of asthmatic symptoms in patients with LAR in the context of AIT is unexplored. Objective The efficacy and safety of AIT in patients with LAR towards birch pollen were investigated. The possibility of concomitant local allergic asthma in studied patients and the impact of AIT on it were examined. Methods 36 patients with LAR towards birch were included in three years of AIT in a double-blind, placebo-control study. Primary outcome measurement was the mean changes in the combined symptom and medication scores (CSMSs) after AIT, and the second is the changes in the quality of life (QoL). Skin prick tests, serum, nasal allergen-specific IgE to birch, nasal and bronchial provocation challenge tests with birch allergen, methacholine tests, and spirometry were carried out at baseline and after AIT. Results Mean CSMSs of three years of AIT were significantly decreased in the active group from 5.88 (range: 4.11-9.01) to 1.98 (range: 1.22-4.51; p < 0.05). After three years of AIT, there was a significant increase of toleration for birch allergen from the mean concentration of 6250 ± 1200 SQ-U/ml up to 45000 ± 2500 SQ-U/ml ( p = 0.02) during repeated nasal challenges. 16 patients with LAR had the positive results of methacholine tests, and 11 of them had a positive bronchial challenge to birch allergen. After AIT, the significant decrease of bronchial responsiveness to birch allergen in 5 from 7 patients was confirmed ( p = 0.03). QoL assessed by the use of the RQLQ score was improved after AIT from 1.84 (95% CI: 1.53-1.97) to 1.45 (95% CI: 1.32-1.62) score in the active group after three years of AIT therapy ( p = 0.03). Conclusion AIT to birch can be useful and safe in a patient with local allergic rhinitis and also with concomitant asthmatic symptoms. Further studies are needed.",2020,"QoL assessed by the use of the RQLQ score was improved after AIT from 1.84 (95% CI: 1.53-1.97) to 1.45 (95% CI: 1.32-1.62) score in the active group after three years of AIT therapy ( p = 0.03). ","['16 patients with LAR', 'local allergic rhinitis (LAR', 'patients with LAR', '36 patients with LAR towards birch', 'patients with LAR towards birch pollen']","['allergen immunotherapy (AIT', 'placebo']","['RQLQ score', 'Skin prick tests, serum, nasal allergen-specific IgE to birch, nasal and bronchial provocation challenge tests with birch allergen, methacholine tests, and spirometry', 'positive bronchial challenge to birch allergen', 'Mean CSMSs of three years of AIT', 'efficacy and safety', 'bronchial responsiveness to birch allergen', 'toleration', 'mean changes in the combined symptom and medication scores (CSMSs) after AIT, and the second is the changes in the quality of life (QoL']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C2607914', 'cui_str': 'Allergic rhinitis'}, {'cui': 'C0330312', 'cui_str': 'Betula'}, {'cui': 'C4047367', 'cui_str': 'Birch pollen'}]","[{'cui': 'C0162352', 'cui_str': 'Hyposensitization to allergens'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0430561', 'cui_str': 'Prick test'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0443736', 'cui_str': 'Allergen specific immunoglobulin E'}, {'cui': 'C0330312', 'cui_str': 'Betula'}, {'cui': 'C0205039', 'cui_str': 'Bronchial'}, {'cui': 'C0449428', 'cui_str': 'Provocation'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0002092', 'cui_str': 'Allergen'}, {'cui': 'C0600370', 'cui_str': 'Methacholine'}, {'cui': 'C0037981', 'cui_str': 'Spirometry'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0006265', 'cui_str': 'Bronchial provocation test'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0162352', 'cui_str': 'Hyposensitization to allergens'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0025320', 'cui_str': 'Menopause'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",16.0,0.0582786,"QoL assessed by the use of the RQLQ score was improved after AIT from 1.84 (95% CI: 1.53-1.97) to 1.45 (95% CI: 1.32-1.62) score in the active group after three years of AIT therapy ( p = 0.03). ","[{'ForeName': 'Andrzej', 'Initials': 'A', 'LastName': 'Bozek', 'Affiliation': 'Clinical Department of Internal Medicine, Dermatology and Allergology, Medical University of Silesia, Katowice, Poland.'}, {'ForeName': 'Janne', 'Initials': 'J', 'LastName': 'Winterstein', 'Affiliation': 'Allergy Outpatient Clinic, Research Department, Munchen, Germany.'}, {'ForeName': 'Beata', 'Initials': 'B', 'LastName': 'Galuszka', 'Affiliation': 'PMR Allergy Department, Outpatient Clinic, Swietochlowice, Poland.'}, {'ForeName': 'Jerzy', 'Initials': 'J', 'LastName': 'Jarzab', 'Affiliation': 'Clinical Department of Internal Medicine, Dermatology and Allergology, Medical University of Silesia, Katowice, Poland.'}]",BioMed research international,['10.1155/2020/3408561'] 2193,32596321,A Novel Diagnostic Nomogram for Noninvasive Evaluating Liver Fibrosis in Patients with Chronic Hepatitis B Virus Infection.,"Objective To establish a novel nomogram for diagnosing liver fibrosis in patients with chronic hepatitis B virus (HBV) infection and verify the diagnostic performance of the established nomogram. Methods Patients with chronic HBV infection who met the inclusion and exclusion criteria were enrolled in this retrospective study; 70% and 30% of patients were randomly assigned to training dataset and validation dataset, respectively. The risk factors for liver fibrosis were screened using the univariate and multivariate logistic regression analyses. Based on the results, a nomogram was established and verified. Results 508 patients with chronic HBV infection were included in this study ( n = 355 for training dataset and n = 153 for validation dataset). The logistic regression analysis showed that liver stiffness measurement (LSM), platelet (PLT) count, and prothrombin time (PT) were independent risk factors for liver fibrosis ( P < 0.01), which were used to establish the nomogram. The consistency index (C-index) of the nomogram established for diagnosing liver fibrosis was 0.875. The calibration line and the ideal line were consistent, which indicated that diagnosis of liver fibrosis by the established model was accurate. The values of area under the receiver operator characteristic (ROC) curve (AUROC) for diagnosing liver fibrosis by the nomogram were 0.857 and 0.862 in the training dataset and validation dataset, respectively, which were noticeably higher than those in the well-known serological models, including the aspartate aminotransferase- (AST-) to-platelet ratio index (APRI) scoring model, fibrosis-4 (FIB-4) scoring model, APAG model (including age, PT, albumin, and γ -glutamyl transferase), and S-index model (all P < 0.05). Conclusion LSM, PT, and PLT were found as independent risk factors for liver fibrosis. The established nomogram exhibited an excellent diagnostic performance, and it can more visually and individually evaluate the probability of liver fibrosis in patients with chronic HBV infection.",2020,"The established nomogram exhibited an excellent diagnostic performance, and it can more visually and individually evaluate the probability of liver fibrosis in patients with chronic HBV infection.","['Patients with Chronic Hepatitis B Virus Infection', '508 patients with chronic HBV infection were included in this study ( n = 355 for training dataset and n = 153 for validation dataset', 'patients with chronic HBV infection', 'patients with chronic hepatitis B virus (HBV) infection', 'Patients with chronic HBV infection who met the inclusion and exclusion criteria were enrolled in this retrospective study; 70% and 30% of patients']",[],"['values of area under the receiver operator characteristic (ROC) curve (AUROC) for diagnosing liver fibrosis', 'aspartate aminotransferase- (AST-) to-platelet ratio index (APRI) scoring model, fibrosis-4 (FIB-4) scoring model, APAG model', 'liver stiffness measurement (LSM), platelet (PLT) count, and prothrombin time (PT']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0524909', 'cui_str': 'Chronic type B viral hepatitis'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0150098', 'cui_str': 'Data Set'}, {'cui': 'C0042769', 'cui_str': 'Viral disease'}, {'cui': 'C0019169', 'cui_str': 'Hepatitis B Virus'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0035363', 'cui_str': 'Retrospective Study'}]",[],"[{'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0239946', 'cui_str': 'Hepatic fibrosis'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0005821', 'cui_str': 'thrombocytes'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0032181', 'cui_str': 'Platelet count'}, {'cui': 'C0033707', 'cui_str': 'Prothrombin time'}]",508.0,0.0142013,"The established nomogram exhibited an excellent diagnostic performance, and it can more visually and individually evaluate the probability of liver fibrosis in patients with chronic HBV infection.","[{'ForeName': 'Danying', 'Initials': 'D', 'LastName': 'Cheng', 'Affiliation': 'Center of Liver Disease, Beijing Ditan Hospital Capital Medical University, Beijing 100015, China.'}, {'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Wan', 'Affiliation': 'Statistics Room, Beijing Ditan Hospital Capital Medical University, Beijing 100015, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Sun', 'Affiliation': 'Department of Pathology, Beijing Ditan Hospital Capital Medical University, Beijing 100015, China.'}, {'ForeName': 'Xiaomei', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': 'Center of Liver Disease, Beijing Ditan Hospital Capital Medical University, Beijing 100015, China.'}, {'ForeName': 'Weini', 'Initials': 'W', 'LastName': 'Ou', 'Affiliation': 'Center of Liver Disease, Beijing Ditan Hospital Capital Medical University, Beijing 100015, China.'}, {'ForeName': 'Huichun', 'Initials': 'H', 'LastName': 'Xing', 'Affiliation': 'Center of Liver Disease, Beijing Ditan Hospital Capital Medical University, Beijing 100015, China.'}]",BioMed research international,['10.1155/2020/5218930'] 2194,32596476,Intravenous vs oral acetaminophen in sinus surgery: A randomized clinical trial.,"Background Multimodal perioperative analgesia including acetaminophen is recommended by current guidelines. The comparative efficacy of intravenous vs oral acetaminophen in sinus surgery is unknown. We aimed to determine whether intravenous or oral acetaminophen results in superior postoperative analgesia following sinus surgery. Methods This was a prospective randomized trial with blinded endpoint assessments conducted at a single large academic medical center. Subjects undergoing functional endoscopic sinus surgery were randomized to intravenous vs oral acetaminophen in addition to standard anesthetic and surgical care. The primary outcome was visual analogue scale pain score at 1 hour postoperatively. Results One hundred and ten adult patients were randomized; 9 were excluded from the data analysis. Fifty patients were assigned to intravenous acetaminophen and 51 to oral acetaminophen. Postoperative pain scores at 1 hour (primary endpoint) were not significantly different between the intravenous and oral acetaminophen groups. Similarly, there was no significant difference in pain scores at 24 hours postoperatively. Finally, there was no significant difference in postoperative opioid usage in the postanesthesia care unit or over the first 24 hours postoperatively. Conclusions This is the first comparative efficacy trial of oral vs intravenous acetaminophen in sinus surgery. There was no significant difference in pain scores at 1 or 24 hours postoperatively, and no difference in postoperative opioid use. Intravenous acetaminophen offers no apparent advantage over oral acetaminophen in patients undergoing sinus surgery. Level of Evidence 1b.",2020,Postoperative pain scores at 1 hour (primary endpoint) were not significantly different between the intravenous and oral acetaminophen groups.,"['sinus surgery', 'Fifty patients', 'patients undergoing sinus surgery', 'One hundred and ten adult patients were randomized; 9 were excluded from the data analysis', 'single large academic medical center', 'Subjects undergoing functional endoscopic sinus surgery']","['Intravenous vs oral acetaminophen', 'Intravenous acetaminophen', 'intravenous vs oral acetaminophen', 'acetaminophen', 'oral vs intravenous acetaminophen', 'intravenous or oral acetaminophen']","['pain scores', 'Postoperative pain scores', 'postoperative opioid usage', 'visual analogue scale pain score']","[{'cui': 'C0748725', 'cui_str': 'Sinus operation'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517536', 'cui_str': '110'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0442968', 'cui_str': 'Functional endoscopic sinus surgery'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}]","[{'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0457083', 'cui_str': 'Usage'}, {'cui': 'C2732809', 'cui_str': 'Visual analog scale pain score'}]",110.0,0.179458,Postoperative pain scores at 1 hour (primary endpoint) were not significantly different between the intravenous and oral acetaminophen groups.,"[{'ForeName': 'Ravi', 'Initials': 'R', 'LastName': 'Bhoja', 'Affiliation': 'Department of Anesthesiology and Pain Management The University of Texas Southwestern Dallas Texas USA.'}, {'ForeName': 'Matthew W', 'Initials': 'MW', 'LastName': 'Ryan', 'Affiliation': 'Department of Otolaryngology The University of Texas Southwestern Dallas Texas USA.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Klein', 'Affiliation': 'Department of Anesthesiology and Pain Management The University of Texas Southwestern Dallas Texas USA.'}, {'ForeName': 'Abu', 'Initials': 'A', 'LastName': 'Minhajuddin', 'Affiliation': 'Department of Anesthesiology and Pain Management The University of Texas Southwestern Dallas Texas USA.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Melikman', 'Affiliation': 'Department of Anesthesiology and Pain Management The University of Texas Southwestern Dallas Texas USA.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Hamza', 'Affiliation': 'Department of Anesthesiology and Pain Management The University of Texas Southwestern Dallas Texas USA.'}, {'ForeName': 'Bradley F', 'Initials': 'BF', 'LastName': 'Marple', 'Affiliation': 'Department of Otolaryngology The University of Texas Southwestern Dallas Texas USA.'}, {'ForeName': 'David L', 'Initials': 'DL', 'LastName': 'McDonagh', 'Affiliation': 'Department of Anesthesiology and Pain Management The University of Texas Southwestern Dallas Texas USA.'}]",Laryngoscope investigative otolaryngology,['10.1002/lio2.375'] 2195,32596485,Threshold sound conditioning in the treatment of sensorineural hearing loss.,"Objectives/hypothesis Sensorineural hearing loss is one of the most common human disorders, with increasing incidence in elderly patients, severely restricting normal activities, and lowering quality of life. The introduction of sound conditioning has the potential to activate auditory pathway plasticity and improve basal frequency hearing. Our objective was to evaluate the safety and efficacy of threshold sound conditioning (TSC). The null hypothesis in this study was that TSC does not have a significant effect on auditory threshold amelioration. Methods Pure tone audiometry (PTA) was performed and hearing thresholds were measured once at baseline, and a second time following TSC intervention. Data were analyzed using an intention-to treat design. Results The TSC group (78%) significantly differed from the control group (44%) on auditory threshold amelioration; P = .008091 in DV1, P = .000546 in DV2 by Scheffe's post hoc test. Female subjects (77%) showed a significant difference in DV1 from male subjects (47%); P = .025468 in DV1 by Scheffe's post hoc test. Older subjects (75%) showed no significant difference from younger subjects (53%); P = .139149 in DV1, P = .082920 in DV2 by Scheffe's post hoc test. Conclusions We observed a significant improvement in a narrow band frequency threshold in this randomized controlled prospective clinical study in a broad range of subjects. These data have important clinical implications since there is no current long-term therapy for this widespread and growing disability. Additional physiologic, mechanistic, and molecular studies are necessary to fully elucidate the pathophysiology and mechanism of action of TSC. Level of Evidence 1a.",2020,The TSC group (78%) significantly differed from the control group (44%) on auditory threshold amelioration; ,"['sensorineural hearing loss', 'elderly patients']","['Methods\n\n\nPure tone audiometry (PTA', 'TSC', 'Threshold sound conditioning', 'threshold sound conditioning (TSC']",['safety and efficacy'],"[{'cui': 'C0018784', 'cui_str': 'Sensorineural hearing loss'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0004292', 'cui_str': 'Pure tone audiometry'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0037709', 'cui_str': 'Sonic Radiation'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",,0.0392237,The TSC group (78%) significantly differed from the control group (44%) on auditory threshold amelioration; ,"[{'ForeName': 'Eunyee', 'Initials': 'E', 'LastName': 'Kwak', 'Affiliation': 'Sound Vaccine, Inc. Seoul Republic of Korea.'}, {'ForeName': 'Sangyeop', 'Initials': 'S', 'LastName': 'Kwak', 'Affiliation': 'Sound Vaccine, Inc. Seoul Republic of Korea.'}]",Laryngoscope investigative otolaryngology,['10.1002/lio2.399'] 2196,32596627,Differentiating anxiety from fear: an experimental-pharmacological approach.,"Gray's theory of personality postulates that fear and anxiety are distinct emotional systems with only the latter being sensitive to anxiolytic drugs. His work was mainly based on animal research, and translational studies validating his theory are scarce. Previous work in humans showed an influence of the benzodiazepine lorazepam on both systems, however, dependent on dosage (1 and 2 mg) and personality differences in negative emotionality. The present study aims to replicate these findings, and in addition tests the drug threshold effect by introducing a lower dosage of 0.5 mg lorazepam. Fifty healthy adults (23 males, age mean 22.40, SD ± 3.68) participated in an experimental threat-avoidance paradigm designed to dissociate risk assessment intensity (RAI, reflecting anxiety) and flight intensity (FI, reflecting fear) and completed two self-report questionnaires assessing facets of negative emotionality ( Spielberger State Trait Anxiety Inventory and Fear Survey Schedule ). In a randomized placebo-controlled within-subjects design, 0.5 and 1 mg of lorazepam were applied per os. Saccadic peak velocity was assessed by means of eye-tracking in order to control for sedating drug effects. Results showed the expected and specific anxiolytic effect of lorazepam on RAI, however, only in the 0.5 mg condition. FI was not influenced by lorazepam, and previous findings of interaction effects of lorazepam with self-reported negative emotionality could not be corroborated. Overall, this study demonstrates anxiolytic effects of lorazepam in dosages ≤1 mg in the absence of a drug effect on fear using a translational behavioural task. However, a putative moderating role of personality on defensive behaviour has to be clarified in future research.",2020,"FI was not influenced by lorazepam, and previous findings of interaction effects of lorazepam with self-reported negative emotionality could not be corroborated.","['Fifty healthy adults (23 males, age mean 22.40, SD ± 3.68) participated in an experimental threat-avoidance paradigm designed to']","['lorazepam', 'benzodiazepine lorazepam', 'placebo']","['Saccadic peak velocity', 'dissociate risk assessment intensity (RAI, reflecting anxiety) and flight intensity (FI, reflecting fear) and completed two self-report questionnaires assessing facets of negative emotionality ( Spielberger State Trait Anxiety Inventory and Fear Survey Schedule ']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}]","[{'cui': 'C0024002', 'cui_str': 'Lorazepam'}, {'cui': 'C0005064', 'cui_str': 'Benzodiazepine Compounds'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0086930', 'cui_str': 'Risk assessment'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C3178806', 'cui_str': 'Right Atrial Isomerism'}, {'cui': 'C0558058', 'cui_str': 'Reflecting'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0222679', 'cui_str': 'Structure of articular surface of bone'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0542317', 'cui_str': 'Character trait finding of affective stability'}, {'cui': 'C0451497', 'cui_str': 'Spielberger state-trait anxiety inventory'}, {'cui': 'C0451158', 'cui_str': 'Fear survey schedule'}]",50.0,0.0222839,"FI was not influenced by lorazepam, and previous findings of interaction effects of lorazepam with self-reported negative emotionality could not be corroborated.","[{'ForeName': 'Julia V', 'Initials': 'JV', 'LastName': 'Lippold', 'Affiliation': 'Department of Psychology, University of Bonn, Bonn, Germany.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Ettinger', 'Affiliation': 'Department of Psychology, University of Bonn, Bonn, Germany.'}, {'ForeName': 'René', 'Initials': 'R', 'LastName': 'Hurlemann', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Bonn, Bonn, Germany.'}, {'ForeName': 'Philip J', 'Initials': 'PJ', 'LastName': 'Corr', 'Affiliation': 'Department of Psychology, City, University of London, London, UK.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Reuter', 'Affiliation': 'Department of Psychology, University of Bonn, Bonn, Germany.'}, {'ForeName': 'Adam M', 'Initials': 'AM', 'LastName': 'Perkins', 'Affiliation': ""Department of Psychological Medicine, Institute of Psychiatry, King's College London, London, UK.""}]",Personality neuroscience,['10.1017/pen.2020.1'] 2197,32596630,The effectiveness of digital multimedia presentation of trial information on recruitment and retention of patients: Protocol for a study within a trial (SWAT).,"Background: Studies within trials (SWATs) present an opportunity to examine design factors that may impact on the successful delivery of trials. One area in need of research is trial recruitment. Recruiting patients to trials is a major challenge facing trialists. Failure to meet recruitment targets can result in delays and underpowered studies. This SWAT evaluates the effectiveness of hand-held digital multimedia presentation of trial information and standard written patient information to potential participants on recruitment and retention to a host trial. Methods : This is the protocol for SWAT 15, a two-group, embedded parallel randomised controlled trial (RCT) (ISRCTN12838042) designed within a host trial - the SATIN trial (ISRCTN88111427), a RCT designed for implementation in the Irish primary care setting. The SWAT eligibility criteria was determined by the host trial. General practices who agree to participate in the host trial will provide women (participants) who are willing to consider participating in the host trial with either a multimedia digital information resource facilitated through a handheld tablet device, plus a written participant information leaflet (Intervention) or a written participant information leaflet (comparator). Outcomes are recruitment and retention to the host SATIN trial and participant's quality of decision-making. Discussion : Although designed to be implemented in a host trial, the host trial, was suspended and therefore this SWAT was not implemented. The protocol and the lessons learnt whilst developing it offer guidance to researchers who wish to answer similar research questions in the future in a similar context or setting.   Trial registration : ISRCTN Registry ISRCTN12838042 (11/10/2017).",2020,"This is the protocol for SWAT 15, a two-group, embedded parallel randomised controlled trial (RCT)","['General practices who agree to participate in the host trial will provide women (participants) who are willing to consider participating in the host trial with either a', 'Discussion ']","['multimedia digital information resource facilitated through a handheld tablet device, plus a written participant information leaflet (Intervention) or a written participant information leaflet (comparator']",[],"[{'cui': 'C0015607', 'cui_str': 'Family practice'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0600109', 'cui_str': 'Willing'}, {'cui': 'C0557061', 'cui_str': 'Discussion'}]","[{'cui': 'C0376478', 'cui_str': 'Multimedium'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C1512759', 'cui_str': 'Information Resources'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0043266', 'cui_str': 'Writing'}]",[],,0.198009,"This is the protocol for SWAT 15, a two-group, embedded parallel randomised controlled trial (RCT)","[{'ForeName': 'Sinead', 'Initials': 'S', 'LastName': 'Duane', 'Affiliation': 'J.E. Cairnes School of Business & Economics, National University of Ireland, Galway, Ireland.'}, {'ForeName': 'Akke', 'Initials': 'A', 'LastName': 'Vellinga', 'Affiliation': 'Discipline of Bacteriology, National University of Ireland, Galway, Ireland.'}, {'ForeName': 'Valerie', 'Initials': 'V', 'LastName': 'Smith', 'Affiliation': 'School of Nursing and Midwifery, Trinity College Dublin, Dublin, Dublin, Ireland.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Tierney', 'Affiliation': 'HRB Primary Care Clinical Trial Network Ireland, National University of Ireland, Galway, Ireland.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Beecher', 'Affiliation': 'HRB Trials Methodology Research Network, National University of Ireland, Galway, Ireland.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Burke', 'Affiliation': 'HRB Trials Methodology Research Network, National University of Ireland, Galway, Ireland.'}, {'ForeName': 'Andrew W', 'Initials': 'AW', 'LastName': 'Murphy', 'Affiliation': 'Discipline of General Practice, National University of Ireland, Galway, Ireland.'}, {'ForeName': 'Declan', 'Initials': 'D', 'LastName': 'Devane', 'Affiliation': 'HRB Trials Methodology Research Network, National University of Ireland, Galway, Ireland.'}]",HRB open research,['10.12688/hrbopenres.12994.1'] 2198,32596649,Effects of Jian Pi Qu Shi Formula on intestinal bacterial flora in patients with idiopathic membranous nephropathy: A prospective randomized controlled trial.,"Background The incidence of idiopathic membranous nephropathy (IMN) has recently increased remarkably. Immune dysfunction caused by disordered intestinal flora might be an important factor affecting IMN. The Jian Pi Qu Shi Formula (JPQSF) shows promise in treating IMN. Here, we sequenced 16S rRNA genes to compare intestinal flora between patients with IMN and healthy persons. We also conducted a randomized controlled clinical trial to further compare the intestinal flora of patients with IMN treated with traditional Chinese medicine (TCM) and western medicine (WM). Methods Among 40 patients with IMN treated at Department of Nephrology in Xiyuan Hospital, Chinese Academy of Traditional Chinese Medicine between July 2016 and December 2018, we compared 30 of them with 10 healthy persons (controls). The IMN group was randomly assigned to receive JPQSF (TCM) or immunosuppressant WM therapy in ( n  = 15 per group) for 6 months. Intestinal microbiota diversity was analyzed using alpha diversity and beta diversity. Intestinal flora that significantly differed between the groups was analyzed using MetaStat. The effects and safety of the therapies were determined based on the values for plasma albumin, 24-h urine protein excretion, serum creatinine, urea nitrogen, estimate glomerular filtration rate (eGFR), complete blood count, and liver enzymes. All data were statistically analyzed using Statistical Package for the Social Sciences (SPSS) 20.0 statistical software. Results Baseline characteristics did not significantly differ between the IMN and healthy groups, or the TCM and WM groups. After six months of treatment, 24-h urinary protein significantly declined in the TCM and WM groups (before and after treatment: 3.24 ± 1.74 vs. 1.73 ± 1.85 g, P  < 0.05 and 3.94 ± 1.05 vs. 1.91 ± 1.18 g, P  < 0.05, respectively). Plasma albumin was significantly increased in the TCM group (before vs. after treatment: 32.44 ± 9.04 vs. 39.99 ± 7.03 g/L, P  < 0.05), but did not significantly change in the WM group (31.55 ± 4.23 vs. 34.83 ± 9.14 g/L, P >  0.05). Values for urea nitrogen, serum creatinine, and eGFR did not significantly change in either group. The alpha diversity index for intestinal flora differed between the IMN and healthy groups, and the TCM and WM groups. Comparisons of multiple samples (beta diversity) revealed differences in intestinal flora between the IMN and healthy groups, and the TCM and WM groups. The Metastat analysis findings showed that the main genera that differed between the IMN group before treatment and the healthy group were Christensenellaceae_R-7_group, Bifidobacterium (77), Dorea, Escherichia-Shigella, Parabacteroides, Bifidobacterium, and Coprococcus_3. After TCM therapy, the main differential genera were Butyricimonas, Bacteroides, Alistipes, and Lachnospira, and after WM therapy, these were Ruminococcus_2, Lachnospiraceae_ND3007_group, Lachnospira, Bifidobacterium, Alistipes, and [Eubacterium]_ventriosum_group. Conclusion Patients with IMN might have disordered intestinal flora, and JPQSF can regulate intestinal flora in patients with IMN.",2020,"Plasma albumin was significantly increased in the TCM group (before vs. after treatment: 32.44 ± 9.04 vs. 39.99 ± 7.03 g/L, P  < 0.05), but did not significantly change in the WM group (31.55 ± 4.23 vs. 34.83 ± 9.14 g/L, P >  0.05).","['patients with IMN treated with traditional Chinese medicine (TCM) and western medicine (WM', '40 patients with IMN treated at Department of Nephrology in Xiyuan Hospital, Chinese Academy of Traditional Chinese Medicine between July 2016 and December 2018', 'patients with IMN and healthy persons', '10 healthy persons (controls', 'patients with idiopathic membranous nephropathy']","['Jian Pi Qu Shi Formula', 'TCM', 'JPQSF (TCM) or immunosuppressant WM therapy', 'Jian Pi Qu Shi Formula (JPQSF', 'IMN']","['Plasma albumin', 'Values for urea nitrogen, serum creatinine, and eGFR', '24-h urinary protein', 'idiopathic membranous nephropathy (IMN', 'plasma albumin, 24-h urine protein excretion, serum creatinine, urea nitrogen, estimate glomerular filtration rate (eGFR), complete blood count, and liver enzymes', 'intestinal flora', 'alpha diversity index for intestinal flora', 'Intestinal flora', 'Intestinal microbiota diversity', 'intestinal bacterial flora']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086445', 'cui_str': 'Idiopathic membranous glomerulonephritis'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0025124', 'cui_str': 'Traditional Chinese Medicine'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0027712', 'cui_str': 'Nephrology'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0000876', 'cui_str': 'Academies'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0027452', 'cui_str': 'National Health Insurance'}, {'cui': 'C0025124', 'cui_str': 'Traditional Chinese Medicine'}, {'cui': 'C0021081', 'cui_str': 'Immunosuppressant agent'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0086445', 'cui_str': 'Idiopathic membranous glomerulonephritis'}]","[{'cui': 'C0857876', 'cui_str': 'Plasma albumin'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0600137', 'cui_str': 'Blood urea nitrogen'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0086445', 'cui_str': 'Idiopathic membranous glomerulonephritis'}, {'cui': 'C0262923', 'cui_str': 'Urine protein test'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0009555', 'cui_str': 'Complete blood count'}, {'cui': 'C0443764', 'cui_str': 'Liver enzyme'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}]",40.0,0.0496022,"Plasma albumin was significantly increased in the TCM group (before vs. after treatment: 32.44 ± 9.04 vs. 39.99 ± 7.03 g/L, P  < 0.05), but did not significantly change in the WM group (31.55 ± 4.23 vs. 34.83 ± 9.14 g/L, P >  0.05).","[{'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Lang', 'Affiliation': 'Department of Nephrology, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing 100091, China.'}, {'ForeName': 'Xin-Hui', 'Initials': 'XH', 'LastName': 'Wang', 'Affiliation': 'Department of Nephrology, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing 100091, China.'}, {'ForeName': 'Ai-Feng', 'Initials': 'AF', 'LastName': 'Li', 'Affiliation': 'Department of Nephrology, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing 100091, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Liang', 'Affiliation': 'Department of Nephrology, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing 100091, China.'}, {'ForeName': 'Bao-Chen', 'Initials': 'BC', 'LastName': 'Zhu', 'Affiliation': 'Department of Pharmacy, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing 100700, China.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Shi', 'Affiliation': 'Department of Nephrology, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing 100091, China.'}, {'ForeName': 'Yong-Qiu', 'Initials': 'YQ', 'LastName': 'Zheng', 'Affiliation': 'Drug Research and Development Center, School of Pharmacy, Anhui Provincial Engineering Research Center for Polysaccharide Drugs, Wannan Medical College, Wuhu, Anhui 241002 China.'}, {'ForeName': 'Ren-Huan', 'Initials': 'RH', 'LastName': 'Yu', 'Affiliation': 'Department of Nephrology, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing 100091, China.'}]",Chronic diseases and translational medicine,['10.1016/j.cdtm.2020.04.004'] 2199,31834239,"Effect of Intravenous Aminocaproid Acid on Blood Loss and Transfusion Requirements After Bilateral Varus Rotational Osteotomy: A Double-blind, Placebo-controlled Randomized Trial.","BACKGROUND ε-Aminocaproic acid (EACA) is an antifibrinolytic agent that has been shown to decrease blood loss and transfusion requirements in several populations undergoing various surgical procedures. However, the efficacy of EACA has not been assessed in pediatric patients with cerebral palsy undergoing bilateral varus rotational femoral osteotomies. The purpose of this study was to assess the efficacy of intravenous EACA in reducing calculated intraoperative blood loss and transfusions in this population. METHODS Patients aged 18 years or younger were eligible. Patients were randomized to receive EACA or placebo (saline), and randomization was stratified based on sex and whether or not additional soft tissue or osseous procedures were performed. On the basis of retrospective data, the calculated sample size was 12 patients per arm to detect a difference of 250-mL blood loss. The primary outcome was calculated intraoperative blood loss. Secondary outcomes included transfusion requirements, 24-hour drain output, length of stay, and incidence of complications. RESULTS The mean age of patients in this study was 8 years (SD: 2.4 y). There were no differences in age, sex, height, weight, type of anesthesia, operative time, and associated procedures between the EACA and placebo groups (P>0.05). Preoperative hematocrit was lower in the EACA group (37.1 vs. 40.0, P=0.04). Calculated intraoperative blood loss was 536 mL in the EACA group and 628 mL in the placebo group (P=0.45). Transfusions were required in 62% of patients in the EACA group and 67% of patients in the placebo group (P=0.68). Total 24-hour drain output was 72.5 mL in the EACA group and 103.3 mL in the placebo group (P=0.37). Length of stay was similar between both groups, and there were no drug or placebo-related complications in either group. CONCLUSIONS There was no difference in blood loss or transfusion requirements associated with EACA compared with placebo; however, this study is underpowered to detect smaller differences in blood loss. Additional studies with larger sample sizes are needed to confirm these findings and further elucidate the indications for antifibrinolytic agents in pediatric patients. LEVEL OF EVIDENCE Level I.",2019,Transfusions were required in 62% of patients in the EACA group and 67% of patients in the placebo group (P=0.68).,"['several populations undergoing various surgical procedures', 'pediatric patients', 'After Bilateral Varus Rotational Osteotomy', 'Patients aged 18 years or younger were eligible', 'pediatric patients with cerebral palsy undergoing bilateral varus rotational femoral osteotomies']","['Placebo', 'ε-Aminocaproic acid (EACA', 'EACA', 'EACA or placebo (saline', 'Intravenous Aminocaproid Acid', 'placebo']","['Length of stay', 'blood loss or transfusion requirements', 'Total 24-hour drain output', 'Preoperative hematocrit', '250-mL blood loss', 'Blood Loss and Transfusion Requirements', 'blood loss and transfusion requirements', 'Transfusions', 'calculated intraoperative blood loss', 'transfusion requirements, 24-hour drain output, length of stay, and incidence of complications', 'blood loss', 'Calculated intraoperative blood loss']","[{'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0443345', 'cui_str': 'Varus'}, {'cui': 'C0407433', 'cui_str': 'Rotational osteotomy'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0007789', 'cui_str': 'Cerebral palsy'}, {'cui': 'C0445237', 'cui_str': 'Rotational'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}, {'cui': 'C0029468', 'cui_str': 'Osteotomy'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0000608', 'cui_str': '6-Aminocaproic Acid'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0001128', 'cui_str': 'Acid'}]","[{'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0013103', 'cui_str': 'Drainage procedure'}, {'cui': 'C3251815', 'cui_str': 'Measurement of fluid output'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0018935', 'cui_str': 'Hematocrit determination'}, {'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C0444686', 'cui_str': 'Calculated'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",,0.423115,Transfusions were required in 62% of patients in the EACA group and 67% of patients in the placebo group (P=0.68).,"[{'ForeName': 'Ishaan', 'Initials': 'I', 'LastName': 'Swarup', 'Affiliation': ""Division of Pediatric Orthopaedic Surgery, University of California, San Francisco, UCSF Benioff Children's Hospital Oakland, Oakland, CA.""}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Nguyen', 'Affiliation': 'Healthcare Research Institute.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Edmonds', 'Affiliation': 'Division of Anesthesiology.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Dodwell', 'Affiliation': 'Division of Pediatric Orthopaedic Surgery, Hospital for Special Surgery, New York, NY.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Scher', 'Affiliation': 'Division of Pediatric Orthopaedic Surgery, Hospital for Special Surgery, New York, NY.'}]",Journal of pediatric orthopedics,['10.1097/BPO.0000000000001480'] 2200,31837719,The role of teacher-student relationships in predicting teachers' personal accomplishment and emotional exhaustion.,"Teaching is a uniquely stressful profession. Though previous work has drawn attention to the high levels of burnout teachers report experiencing and its impact on students, comparatively less work has investigated what influences teachers' burnout itself. Guided by Lazarus' (1991) transactional model of stress and coping, the present study explored the links between the proximal resource of teachers' relationships with students and burnout. Specifically, we investigated the association between classroom aggregated teacher reports of relational closeness and conflict, and two components of burnout: personal accomplishment and emotional exhaustion. Results indicated that teachers who reported close relationships with their students also reported higher levels of personal accomplishment over the academic year, whereas more conflictual relationships were associated with increased emotional exhaustion. Implications for relational quality with students as a central influence on teachers' wellbeing are discussed.",2019,"Results indicated that teachers who reported close relationships with their students also reported higher levels of personal accomplishment over the academic year, whereas more conflictual relationships were associated with increased emotional exhaustion.",[],"[""Guided by Lazarus' (1991) transactional model of stress and coping""]","['personal accomplishment', 'emotional exhaustion']",[],"[{'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C1172941', 'cui_str': 'Pbx4 protein, zebrafish'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}]","[{'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0392674', 'cui_str': 'Exhaustion'}]",,0.0138495,"Results indicated that teachers who reported close relationships with their students also reported higher levels of personal accomplishment over the academic year, whereas more conflictual relationships were associated with increased emotional exhaustion.","[{'ForeName': 'Catherine M', 'Initials': 'CM', 'LastName': 'Corbin', 'Affiliation': 'The University of Virginia, USA. Electronic address: cc9gm@virginia.edu.'}, {'ForeName': 'Pilar', 'Initials': 'P', 'LastName': 'Alamos', 'Affiliation': 'The University of Virginia, USA.'}, {'ForeName': 'Amy E', 'Initials': 'AE', 'LastName': 'Lowenstein', 'Affiliation': 'Fordham University, USA.'}, {'ForeName': 'Jason T', 'Initials': 'JT', 'LastName': 'Downer', 'Affiliation': 'The University of Virginia, USA.'}, {'ForeName': 'Joshua L', 'Initials': 'JL', 'LastName': 'Brown', 'Affiliation': 'Fordham University, USA.'}]",Journal of school psychology,['10.1016/j.jsp.2019.10.001'] 2201,32020725,Level of agreement between adolescents' self-assessment and parent proxy report of health-related quality of life in adolescents with sickle cell disease.,"BACKGROUND We aim to assess the levels of agreement between parents, as proxies, and Jamaican adolescents living with sickle cell disease (SCD) in the reporting of the adolescent's quality of life. PROCEDURES This cross-sectional study assessed 102 patient/proxy pairs on quality of life of adolescents with SCD using the PedsQL-SCD module. The level of agreement among pairs was assessed starting with broad group-level approaches (the Wilcoxon signed-rank test augmented by exploring percentage agreement) tapering to individual-level approaches (intraclass correlation coefficients [ICCs] supplemented with Bland-Altman plots). RESULTS Most patients (76.5%) had homozygous SS disease (45.1% females; mean age 15.2 ± 1.5 years). Median total pediatric quality of life (PedsQL) scores were 79.1 (adolescent report) and 80.2 (parental report) (P = .60). There were 11.8% underestimation and 12.7% overestimation of overall health-related quality of life (HRQOL) by parents. The highest perfect agreement existed on the ""pain and hurt"" domain for both male and female adolescents (85.7% and 84.4%, respectively). Overestimation was highest on the ""social communication"" domain for both male and female adolescents (19.6% and 34.8%, respectively). Parents exhibited good agreement on total PedsQL scores in male adolescents (ICC = 0.70), but moderate agreement (ICC = 0.43) in female adolescents. Generally, parents underestimated their male child's functioning and overestimated the female child's functioning on the various domains. CONCLUSIONS Parents and adolescents exhibit fair agreement in assessment of the adolescent's overall HRQOL but differ on subjective domains. Agreement varies by sex of the affected teen where girls' HRQOL is generally overestimated by the parental proxy. Interventions to improve parents' understanding of their children's psychosocial needs are needed.",2020,"Overestimation was highest on the ""social communication"" domain for both male and female adolescents (19.6% and 34.8%, respectively).","['Jamaican adolescents living with sickle cell disease (SCD', 'adolescents with sickle cell disease', '102 patient/proxy pairs on quality of life of adolescents with SCD using the PedsQL-SCD module']",[],"['pain and hurt"" domain', 'Median total pediatric quality of life (PedsQL) scores', 'social communication"" domain', 'total PedsQL scores', 'homozygous SS disease', 'overall health-related quality of life (HRQOL']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0002895', 'cui_str': 'Sickling disorder due to hemoglobin S'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0600420', 'cui_str': 'Proxy'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C3542953', 'cui_str': 'Module'}]",[],"[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0019904', 'cui_str': 'Homozygote'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}]",,0.0323359,"Overestimation was highest on the ""social communication"" domain for both male and female adolescents (19.6% and 34.8%, respectively).","[{'ForeName': 'Alphanso', 'Initials': 'A', 'LastName': 'Blake', 'Affiliation': 'Caribbean Institute for Health Research-Sickle Cell Unit, The University of the West Indies, Kingston 7, Jamaica.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Guthrie-Dixon', 'Affiliation': 'Caribbean Institute for Health Research-Epidemiology Research Unit, The University of the West Indies, Kingston 7, Jamaica.'}, {'ForeName': 'Marlyn', 'Initials': 'M', 'LastName': 'Grindley', 'Affiliation': 'Caribbean Institute for Health Research-Sickle Cell Unit, The University of the West Indies, Kingston 7, Jamaica.'}, {'ForeName': 'Antoinette', 'Initials': 'A', 'LastName': 'Barton-Gooden', 'Affiliation': 'School of Nursing, The University of the West Indies, Kingston 7, Jamaica.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Knight-Madden', 'Affiliation': 'Caribbean Institute for Health Research-Sickle Cell Unit, The University of the West Indies, Kingston 7, Jamaica.'}, {'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Asnani', 'Affiliation': 'Caribbean Institute for Health Research-Sickle Cell Unit, The University of the West Indies, Kingston 7, Jamaica.'}]",Pediatric blood & cancer,['10.1002/pbc.28198'] 2202,32591498,"A randomized, double-blind, active placebo-controlled study of efficacy, safety, and durability of repeated vs single subanesthetic ketamine for treatment-resistant depression.","The strategy of repeated ketamine in open-label and saline-control studies of treatment-resistant depression suggested greater antidepressant response beyond a single ketamine. However, consensus guideline stated the lack of evidence to support frequent ketamine administration. We compared the efficacy and safety of single vs. six repeated ketamine using midazolam as active placebo. Subjects received either six ketamine or five midazolam followed by a single ketamine during 12 days followed by up to 6-month post-treatment period. The primary end point was the change from baseline in the Montgomery-Åsberg Depression Rating Scale (MADRS) score at 24 h after the last infusion. Fifty-four subjects completed all six infusions. For the primary outcome measure, there was no significant difference in change of MADRS scores between six ketamine group and single ketamine group at 24 h post-last infusion. Repeated ketamine showed greater antidepressant efficacy compared to midazolam after five infusions before receiving single ketamine infusion. Remission and response favored the six ketamine after infusion 4 and 5, respectively, compared to midazolam before receiving single ketamine infusion. For those who responded, the median time-to-relapse was nominally but not statistically different (2 and 6 weeks for the single and six ketamine group, respectively). Repeated infusions were relatively well-tolerated. Repeated ketamine showed greater antidepressant efficacy to midazolam after five infusions but fell short of significance when compared to add-on single ketamine to midazolam at the end of 2 weeks. Increasing knowledge on the mechanism of ketamine should drive future studies on the optimal balance of dosing ketamine for maximum antidepressant efficacy with minimum exposure.",2020,"For the primary outcome measure, there was no significant difference in change of MADRS scores between six ketamine group and single ketamine group at 24 h post-last infusion.",[],"['subanesthetic ketamine', 'six ketamine or five midazolam', 'ketamine', 'active placebo', 'midazolam', 'placebo']","['median time-to-relapse', 'Remission and response', 'Montgomery-Åsberg Depression Rating Scale (MADRS) score', 'efficacy and safety', 'antidepressant efficacy', 'change of MADRS scores', 'efficacy, safety, and durability']",[],"[{'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0026056', 'cui_str': 'Midazolam'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C2960593', 'cui_str': 'Montgomery-Åsberg depression rating scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",54.0,0.202748,"For the primary outcome measure, there was no significant difference in change of MADRS scores between six ketamine group and single ketamine group at 24 h post-last infusion.","[{'ForeName': 'Paulo R', 'Initials': 'PR', 'LastName': 'Shiroma', 'Affiliation': 'Geriatric Psychiatrist, Minneapolis VA Health Care System, Mental Health Service Line, Minneapolis, MN, USA. paulo.shiroma@va.gov.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Thuras', 'Affiliation': 'Statistician/Research Methodologist, Minneapolis VA Health Care System, Mental Health Service Line; and Assistant Professor/Research Associate, Department of Psychiatry, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Wels', 'Affiliation': 'Staff Anesthesiologist, Minneapolis VA Health Care System, Mental Health Service Line; and Clinical Instructor, University of Minnesota Medical School, Minneapolis, MN, USA.'}, {'ForeName': 'C Sophia', 'Initials': 'CS', 'LastName': 'Albott', 'Affiliation': 'Department of Psychiatry, University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Erbes', 'Affiliation': 'Staff Psychologist, Minneapolis VA Health Care System, Mental Health Service Line; and Associate Professor of Psychiatry, University of Minnesota Medical School, Minneapolis, MN, USA.'}, {'ForeName': 'Susannah', 'Initials': 'S', 'LastName': 'Tye', 'Affiliation': 'Senior Research Fellow, Queensland Brain Institute, The University of Queensland, Queensland, Australia; and Assistant Professor Psychiatry, Psychology and Pharmacology Translational Neuroscience Laboratory, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Kelvin O', 'Initials': 'KO', 'LastName': 'Lim', 'Affiliation': 'Drs. T.J. and Ella M. Arneson Land-Grant Chair in Human Behavior, Professor of Psychiatry, Vice Chair for Research Department of Psychiatry, University of Minnesota, Minneapolis, MN, USA.'}]",Translational psychiatry,['10.1038/s41398-020-00897-0'] 2203,32591562,"Effect of palmitoylethanolamide on inner retinal function in glaucoma: a randomized, single blind, crossover, clinical trial by pattern-electroretinogram.","Glaucoma is a neurodegenerative disease, our study aimed to evaluate the potential effects of Palmitoylethanolamide (PEA) supplementation on RGCs function by PERG examination, and to record effects on intraocular pressure, visual field and quality of life. It was a single centre, randomized, prospective, single blind, two treatment, two period crossover study on stable glaucoma patients on topical monotherapy comparing current topical therapy alone or additioned with PEA 600 mg one tablet a day. At baseline, at 4 and at 8 months, all patients underwent to complete ophthalmic examination, pattern electroretinogram, visual field, and quality of life evaluation. 40 patients completed the study: mean age 66.6 ± 7.6 years; 21 (52.5%) male; 35 POAG (87.5%). At baseline, most patients had an early visual field defect, the IOP was well controlled. At the end of the PEA 600 mg supplementation, a significantly higher (mean 0.56 μV, 95% CI 0.30-0.73, p < 0.001) in the P50-wave amplitude was observed; in the PEA period a significantly lower IOP (- 1.6 mmHg, 95% CI - 2 to 1.2, p < 0.001) and higher quality of life scores (+ 6.7, 95% CI 4-9.9, p < 0.001) were observed. Our study is the first to show promising effects of PEA on PERG and on quality of life in glaucoma patients.",2020,"At the end of the PEA 600 mg supplementation, a significantly higher (mean 0.56 μV, 95% CI 0.30-0.73, p < 0.001) in the P50-wave amplitude was observed; in the PEA period a significantly lower IOP (- 1.6 mmHg, 95% CI - 2 to 1.2, p < 0.001) and higher quality of life scores (+ 6.7, 95% CI 4-9.9, p < 0.001) were observed.","['40 patients completed the study: mean age 66.6\u2009±\u20097.6\xa0years; 21 (52.5%) male; 35 POAG (87.5', 'stable glaucoma patients on topical monotherapy comparing current', 'glaucoma', 'glaucoma patients']","['PEA', 'topical therapy alone or additioned with PEA 600\xa0mg one tablet a day', 'palmitoylethanolamide', 'Palmitoylethanolamide (PEA) supplementation']","['quality of life', 'higher quality of life scores', 'IOP', 'complete ophthalmic examination, pattern electroretinogram, visual field, and quality of life evaluation', 'intraocular pressure, visual field and quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517802', 'cui_str': '52.5'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0339573', 'cui_str': 'Primary open angle glaucoma'}, {'cui': 'C4517896', 'cui_str': '87.5'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0017601', 'cui_str': 'Glaucoma'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0521116', 'cui_str': 'Current'}]","[{'cui': 'C0069964', 'cui_str': 'palmidrol'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0578862', 'cui_str': 'Intraocular pressure finding'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0200149', 'cui_str': 'Ophthalmic examination and evaluation'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0013867', 'cui_str': 'Electroretinography'}, {'cui': 'C0042826', 'cui_str': 'Visual field'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}]",,0.275603,"At the end of the PEA 600 mg supplementation, a significantly higher (mean 0.56 μV, 95% CI 0.30-0.73, p < 0.001) in the P50-wave amplitude was observed; in the PEA period a significantly lower IOP (- 1.6 mmHg, 95% CI - 2 to 1.2, p < 0.001) and higher quality of life scores (+ 6.7, 95% CI 4-9.9, p < 0.001) were observed.","[{'ForeName': 'Gemma Caterina Maria', 'Initials': 'GCM', 'LastName': 'Rossi', 'Affiliation': 'University Eye Clinic, Fondazione IRCCS Policlinico S. Matteo, Pavia, Italy. gemma.rossi.md@gmail.com.'}, {'ForeName': 'Luigia', 'Initials': 'L', 'LastName': 'Scudeller', 'Affiliation': 'Clinical Epidemiology and Biometric Unit, Scientific Direction, Fondazione IRCCS Policlinico S. Matteo, Pavia, Italy.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Lumini', 'Affiliation': 'University Eye Clinic, Fondazione IRCCS Policlinico S. Matteo, Pavia, Italy.'}, {'ForeName': 'Federica', 'Initials': 'F', 'LastName': 'Bettio', 'Affiliation': 'University Eye Clinic, Fondazione IRCCS Policlinico S. Matteo, Pavia, Italy.'}, {'ForeName': 'Erica', 'Initials': 'E', 'LastName': 'Picasso', 'Affiliation': 'University Eye Clinic, Fondazione IRCCS Policlinico S. Matteo, Pavia, Italy.'}, {'ForeName': 'Giulio', 'Initials': 'G', 'LastName': 'Ruberto', 'Affiliation': 'University Eye Clinic, Fondazione IRCCS Policlinico S. Matteo, Pavia, Italy.'}, {'ForeName': 'Aba', 'Initials': 'A', 'LastName': 'Briola', 'Affiliation': 'University Eye Clinic, Fondazione IRCCS Policlinico S. Matteo, Pavia, Italy.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Mirabile', 'Affiliation': 'University Eye Clinic, Fondazione IRCCS Policlinico S. Matteo, Pavia, Italy.'}, {'ForeName': 'Alessia', 'Initials': 'A', 'LastName': 'Paviglianiti', 'Affiliation': 'University Eye Clinic, Fondazione IRCCS Policlinico S. Matteo, Pavia, Italy.'}, {'ForeName': 'Gian Maria', 'Initials': 'GM', 'LastName': 'Pasinetti', 'Affiliation': 'Eye Unit, Istituto Beato Palazzolo, Bergamo, Italy.'}, {'ForeName': 'Paolo Emilio', 'Initials': 'PE', 'LastName': 'Bianchi', 'Affiliation': 'University Eye Clinic, Fondazione IRCCS Policlinico S. Matteo, Pavia, Italy.'}]",Scientific reports,['10.1038/s41598-020-67527-z'] 2204,32592568,[General hydro galvanic baths in the treatment of patients with lumbosacral radiculopathy].,"INTRODUCTION Hydrogalvanic baths are a hydrotherapy method based on the combined effect of electric current and fresh water on the body. AIM OF STUDY Scientific evidence and evaluation of the effectiveness of use of general hydrogalvanic baths in the treatment of patients with lumbosacral radiculopathy with the background of degenerative spinal disorder. MATERIALS AND METHODS A randomized comparative clinical trial included 84 patients. The 1st (active) group included 43 patients, the 2nd (control) had 41 patients. Patients of the 1st group received general hydrogalvanic baths. Patients in the control group - drug treatment, including NSAIDs, muscle relaxants, anticonvulsants. The assessment was carried out before treatment, at the end of the course (on the 14th day) and 3 months after the end of treatment according to the results of neurological examination, VAS questionnaires, Pain DETECT, Beck scale, Oswestry scale, SF-36 scales, electroneuromyography (nerve conduction study). RESULTS In patients receiving general hydrogalvanic baths, in comparison with the control group, there was an improvement in sensitivity (the incidence of hypesthesia decreased from 77 to 11%, p =0.008) and conductivity in peripheral sensory fibers. A decrease in pain was observed in both groups, however, a decrease in neuropathic pain was recorded only in patients receiving drug treatment. In the 1st group during therapy, an improvement in the emotional state in patients and a decrease in the level of depression were revealed. An analysis of long-term results showed that the delayed effect of non-drug treatment significantly increased in patients of the 1st group in comparison with the control group ( p <0.05). CONCLUSIONS Exposure to general hydrogalvanic baths is an effective way to treat lumbosacral radiculopathy, the main registered effects are: improvement of sensitivity, reduction of pain and stabilization of the emotional background. However, the studied method does not affect neuropathic pain.",2020,"In patients receiving general hydrogalvanic baths, in comparison with the control group, there was an improvement in sensitivity (the incidence of hypesthesia decreased from 77 to 11%, p =0.008) and conductivity in peripheral sensory fibers.","['43 patients, the 2nd (control) had 41 patients', '84 patients', 'patients with lumbosacral radiculopathy', 'patients with lumbosacral radiculopathy with the background of degenerative spinal disorder']",['general hydrogalvanic baths'],"['sensitivity (the incidence of hypesthesia', 'emotional state', 'conductivity in peripheral sensory fibers', 'delayed effect of non-drug treatment', 'pain', 'neuropathic pain', 'level of depression', 'neurological examination, VAS questionnaires, Pain DETECT, Beck scale, Oswestry scale, SF-36 scales, electroneuromyography (nerve conduction study']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0154738', 'cui_str': 'Lumbosacral radiculopathy'}, {'cui': 'C0011164', 'cui_str': 'Degeneration'}, {'cui': 'C0037933', 'cui_str': 'Disorder of vertebral column'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized'}]","[{'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0020580', 'cui_str': 'Hypesthesia'}, {'cui': 'C0684322', 'cui_str': 'Emotional state finding'}, {'cui': 'C0013777', 'cui_str': 'Electrical Conductivity'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0012173', 'cui_str': 'Dietary fiber'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0027796', 'cui_str': 'Neuralgia'}, {'cui': 'C1319226', 'cui_str': 'Level of depression'}, {'cui': 'C0027853', 'cui_str': 'Neurological examination'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0442726', 'cui_str': 'Detected'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0919609', 'cui_str': 'Electroneuromyography'}, {'cui': 'C0200125', 'cui_str': 'Nerve conduction study'}]",84.0,0.0368616,"In patients receiving general hydrogalvanic baths, in comparison with the control group, there was an improvement in sensitivity (the incidence of hypesthesia decreased from 77 to 11%, p =0.008) and conductivity in peripheral sensory fibers.","[{'ForeName': 'I V', 'Initials': 'IV', 'LastName': 'Borodulina', 'Affiliation': 'Medical scientific educational center, Moscow state university named after M.V. Lomonosov, Moscow, Russia.'}, {'ForeName': 'N G', 'Initials': 'NG', 'LastName': 'Badalov', 'Affiliation': 'Scientific practical center of medical and social rehabilitation named after L.I. Shvetsova, Moscow, Russia.'}, {'ForeName': 'A A', 'Initials': 'AA', 'LastName': 'Mukhina', 'Affiliation': 'National Medical Research Center for Rehabilitation and Balneology, Moscow, Russia.'}, {'ForeName': 'A O', 'Initials': 'AO', 'LastName': 'Gushcha', 'Affiliation': 'Scientific center of neurology, Moscow, Russia.'}, {'ForeName': 'T V', 'Initials': 'TV', 'LastName': 'Marfina', 'Affiliation': 'Medical scientific educational center, Moscow state university named after M.V. Lomonosov, Moscow, Russia.'}, {'ForeName': 'S A', 'Initials': 'SA', 'LastName': 'Volovets', 'Affiliation': 'Scientific practical center of medical and social rehabilitation named after L.I. Shvetsova, Moscow, Russia.'}]","Voprosy kurortologii, fizioterapii, i lechebnoi fizicheskoi kultury",['10.17116/kurort20209703135'] 2205,32592569,[Comparative evaluation of effectiveness of different magnetotherapy regimens in patients with osteoarthritis].,"Impulse low-frequency magnetotherapy is a modern method of treating diseases of the musculoskeletal system, including osteoarthritis. The effectiveness of the therapeutic effect largely depends on the biotropic characteristics of the magnetic fields - the type of magnetic field, induction, frequency, pulse shape, exposure, exposure zone. AIM OF STUDY To conduct a comparative analysis of effectiveness of applying various modes of magnetotherapy using an impulse low-frequency magnetic field in patients with osteoarthritis. MATERIALS AND METHODS A randomized, placebo-controlled clinical trial included 262 patients with grade II-III knee osteoarthritis according to the Kellgren-Lawrence classification. The 1st group included 56 patients who received local magnetic therapy on the knee using a running pulsed magnetic field (RPMF) - 20 mT, frequency 6.25 Hz, exposure time 20 min. The 2nd group included 99 patients who were exposed to a magnetic field using a combination of modes: 5 days - an impulse magnetic field (IMF) with induction of 2 mT, frequency of 100 Hz, then RPMF mode - 20 mT, frequency of 6.25 Hz, duration 20 min, number of procedures - 12. The third group included 97 patients who received placebo-magnetotherapy on the knee joint area. When analyzing the results, the VAS (100 mm) and WOMAC scales were used, as well as the subjective assessment of the treatment results by patients (5-point scale). RESULTS A pronounced symptom-modifying effect of magnetotherapy (according to VAS and WOMAC) was established in the form of a decrease in the severity of pain in patients with gonarthrosis ( p <0.01). There was a significant improvement in pain and stiffness indices, as well as functional characteristics (WOMAC), more pronounced in patients who received a combined regime of exposure to a magnetic field ( p <0.01). The use of magnetotherapy using various modes is safe for patients and does not cause serious adverse events. CONCLUSION The application of magnetotherapy equipment, which allows the use of various biotropic characteristics of magnetic field, is an effective and safe technology for treatment of patients with osteoarthritis.",2020,"There was a significant improvement in pain and stiffness indices, as well as functional characteristics (WOMAC), more pronounced in patients who received a combined regime of exposure to a magnetic field ( p <0.01).","['99 patients who were exposed to a', 'patients with osteoarthritis', '56 patients who received', '262 patients with grade II-III knee osteoarthritis according to the Kellgren-Lawrence classification']","['magnetic field using a combination of modes: 5 days - an impulse magnetic field (IMF', 'local magnetic therapy', 'magnetotherapy', 'placebo-magnetotherapy', 'magnetotherapy regimens', 'placebo']","['pain and stiffness indices', 'WOMAC scales', 'functional characteristics (WOMAC', 'severity of pain']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0008902', 'cui_str': 'Classification'}]","[{'cui': 'C0563533', 'cui_str': 'Magnetic field'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0443235', 'cui_str': 'Impulse'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0872210', 'cui_str': 'Magnetic therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C3472647', 'cui_str': 'Western Ontario and McMaster Universities osteoarthritis index'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",262.0,0.0229588,"There was a significant improvement in pain and stiffness indices, as well as functional characteristics (WOMAC), more pronounced in patients who received a combined regime of exposure to a magnetic field ( p <0.01).","[{'ForeName': 'I P', 'Initials': 'IP', 'LastName': 'Osnovina', 'Affiliation': 'Ivanovo State Medical Academy of the Ministry of Health of Russia, Ivanovo, Russia.'}, {'ForeName': 'N V', 'Initials': 'NV', 'LastName': 'Alekseeva', 'Affiliation': 'Ivanovo State Medical Academy of the Ministry of Health of Russia, Ivanovo, Russia.'}]","Voprosy kurortologii, fizioterapii, i lechebnoi fizicheskoi kultury",['10.17116/kurort20209703143'] 2206,32592571,[Transcerebral magnetic and shock wave therapy in correction of erectile dysfunction].,"Given the complex pathogenesis of erectile dysfunction (ED), the inclusion of not only effective local physiotherapeutic effects, but also general physiotherapy methods into the treatment complexes of patients with ED is most justified. Transcerebral exposure to magnetic fields occupies a special place among them. AIM OF STUDY Development and scientific justification of a new complex physiotherapeutic method, including shock wave therapy (SVT) and transcerebral magnetotherapy, for the treatment of patients with ED. MATERIALS AND METHODS A prospective randomized study was carried out, which included 40 patients with a vasculogenic form of ED who underwent outpatient treatment at the Federal State Budget Scientific Institution «Research Center of the Republic of Kazakhstan» of the Ministry of Health of Russia. The 1st group (comparison) included 20 patients who received only 7 SVT procedures. The 2nd group (main) included 20 patients who received a comprehensive physiotherapeutic effect: topically - SVT (No. 7), transcerebral - running impulse magnetic field (No. 7). RESULTS As a result of course of SVT in combination with transcerebral magnetotherapy, the total score according to the IIEF-5 questionnaire in patients increased by 34.1% ( p <0.05), comparing with patients receiving only SVT (20.7%). In patients of main group, an increase in the quality of hardness of erection according to the Goldstein scale was noted to increase by 30.9%, in patients of comparison group - by 20.5%. It was found that the high clinical results of use of SVT in combination with transcerebral magnetotherapy are based on the compensation of local blood circulation, which manifests itself in eliminating the deficiency of blood supply by improving the tone of arterial vessels and eliminating venous stasis according to laser Doppler flowmetry (LDF). The inclusion of transcerebral magnetotherapy in the treatment complex helps to increase the level of total testosterone. CONCLUSION Higher therapeutic efficacy of the complex treatment of patients with ED using SVT and transcerebral magnetotherapy was revealed.",2020,"In patients of main group, an increase in the quality of hardness of erection according to the Goldstein scale was noted to increase by 30.9%, in patients of comparison group - by 20.5%.","['40 patients with a vasculogenic form of ED who underwent outpatient treatment at the Federal State Budget Scientific Institution «Research Center of the Republic of Kazakhstan» of the Ministry of Health of Russia', 'patients with ED', '20 patients who received a', '20 patients who received only 7 SVT procedures']","['comprehensive physiotherapeutic effect: topically - SVT (No. 7), transcerebral - running impulse magnetic field (No. 7', 'Transcerebral magnetic and shock wave therapy', 'shock wave therapy (SVT) and transcerebral magnetotherapy', 'SVT']","['IIEF-5 questionnaire', 'level of total testosterone', 'Goldstein scale', 'quality of hardness of erection', 'therapeutic efficacy']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0242350', 'cui_str': 'Impotence'}, {'cui': 'C0002423', 'cui_str': 'Outpatient Care'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0006347', 'cui_str': 'Budgets'}, {'cui': 'C0036397', 'cui_str': 'Science'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0022537', 'cui_str': 'Kazakhstan'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0035970', 'cui_str': 'Russian federation - Europe'}, {'cui': 'C1737238', 'cui_str': 'Extracorporeal shock wave therapy'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C1737238', 'cui_str': 'Extracorporeal shock wave therapy'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0443235', 'cui_str': 'Impulse'}, {'cui': 'C0563533', 'cui_str': 'Magnetic field'}, {'cui': 'C0024488', 'cui_str': 'Magnetics'}]","[{'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0202227', 'cui_str': 'Testosterone measurement, total'}, {'cui': 'C0406353', 'cui_str': 'Multiple minute digitate hyperkeratosis of Goldstein'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0018599', 'cui_str': 'Hard'}, {'cui': 'C0030847', 'cui_str': 'Penile erection'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",40.0,0.0156503,"In patients of main group, an increase in the quality of hardness of erection according to the Goldstein scale was noted to increase by 30.9%, in patients of comparison group - by 20.5%.","[{'ForeName': 'T V', 'Initials': 'TV', 'LastName': 'Konchugova', 'Affiliation': 'National Medical Research Center for Rehabilitation and Balneology of the Ministry of Health of Russia, Moscow, Russia.'}, {'ForeName': 'D B', 'Initials': 'DB', 'LastName': 'Kulchitskaya', 'Affiliation': 'National Medical Research Center for Rehabilitation and Balneology of the Ministry of Health of Russia, Moscow, Russia.'}, {'ForeName': 'V A', 'Initials': 'VA', 'LastName': 'Kiyatkin', 'Affiliation': 'National Medical Research Center for Rehabilitation and Balneology of the Ministry of Health of Russia, Moscow, Russia.'}, {'ForeName': 'N V', 'Initials': 'NV', 'LastName': 'Gushchina', 'Affiliation': 'National Medical Research Center for Rehabilitation and Balneology of the Ministry of Health of Russia, Moscow, Russia.'}]","Voprosy kurortologii, fizioterapii, i lechebnoi fizicheskoi kultury",['10.17116/kurort20209703160'] 2207,32592973,Impact of 80 kVp with iterative reconstruction algorithm and low-dose contrast medium on the image quality of craniocervical CT angiography.,"PURPOSE To assess the image quality of 80-kVp craniocervical CT angiography (CCCTA) protocol combined with adaptive statistical iterative reconstruction-V (ASIR-V) and low-dose contrast medium (CM). METHODS A total of 119 patients were randomly divided into three groups. For group A, 120-kVp protocol was followed with 60 ml CM and filtered back projection; for group B, 80-kVp protocol with 60 ml CM and ASIR-V; and for group C, 80-kVp protocol with 45 ml CM and ASIR-V. Both subjective and objective image quality and radiation doses were evaluated. RESULTS Arterial attenuation, signal-to-noise ratio (SNR) and contrast-to-noise ratio (CNR) of the head, neck, and shoulder regions were significantly higher in groups B and C compared with group A. Group C yielded significantly better subjective image quality than that observed in groups A and B (both p < .05). As compared with group A, effective radiation dose and the iodine load of group C were reduced by 51.4% and 25%, respectively. CONCLUSIONS The CCCTA protocol with 80 kVp, ASIR-V, and 45 ml of CM injected at 3 ml/s significantly reduced the radiation dose, iodine load, and iodine delivery rate while providing better subjective and objective image quality, including higher arterial enhancement and a higher SNR and CNR compared with the 120-kVp protocol.",2020,"As compared with group A, effective radiation dose and the iodine load of group C were reduced by 51.4% and 25%, respectively. ",['A total of 119 patients'],"['80-kVp craniocervical CT angiography (CCCTA) protocol combined with adaptive statistical iterative reconstruction-V (ASIR-V) and low-dose contrast medium (CM', '80\xa0kVp with iterative reconstruction algorithm and low-dose contrast medium']","['image quality of craniocervical CT angiography', 'subjective image quality', 'radiation dose, iodine load, and iodine delivery rate', 'Arterial attenuation, signal-to-noise ratio (SNR) and contrast-to-noise ratio (CNR) of the head, neck, and shoulder regions']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C1536105', 'cui_str': 'CT angiography'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}]","[{'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C1536105', 'cui_str': 'CT angiography'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0021966', 'cui_str': 'Iodide salt'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C2986823', 'cui_str': 'Signal-To-Noise Ratio'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0018670', 'cui_str': 'Head structure'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}]",119.0,0.0319457,"As compared with group A, effective radiation dose and the iodine load of group C were reduced by 51.4% and 25%, respectively. ","[{'ForeName': 'Po-An', 'Initials': 'PA', 'LastName': 'Chen', 'Affiliation': 'Department of Radiology, Kaohsiung Veterans General Hospital, No. 386, Ta-Chung 1st Road, Kaohsiung 81362, Taiwan; Faculty of Medicine, School of Medicine, National Yang Ming University, Taipei, Taiwan; Institute of Clinical Medicine, National Yang Ming University, Taipei, Taiwan.'}, {'ForeName': 'Chih-Wei', 'Initials': 'CW', 'LastName': 'Chen', 'Affiliation': 'Department of Radiology, Kaohsiung Veterans General Hospital, No. 386, Ta-Chung 1st Road, Kaohsiung 81362, Taiwan; Faculty of Medicine, School of Medicine, National Yang Ming University, Taipei, Taiwan; Institute of Clinical Medicine, National Yang Ming University, Taipei, Taiwan.'}, {'ForeName': 'Chiung-Chen', 'Initials': 'CC', 'LastName': 'Chou', 'Affiliation': 'Department of Radiology, Kaohsiung Veterans General Hospital, No. 386, Ta-Chung 1st Road, Kaohsiung 81362, Taiwan.'}, {'ForeName': 'Jui-Hsun', 'Initials': 'JH', 'LastName': 'Fu', 'Affiliation': 'Department of Radiology, Kaohsiung Veterans General Hospital, No. 386, Ta-Chung 1st Road, Kaohsiung 81362, Taiwan; Faculty of Medicine, School of Medicine, National Yang Ming University, Taipei, Taiwan; Institute of Clinical Medicine, National Yang Ming University, Taipei, Taiwan.'}, {'ForeName': 'Po-Chin', 'Initials': 'PC', 'LastName': 'Wang', 'Affiliation': 'Department of Radiology, Kaohsiung Veterans General Hospital, No. 386, Ta-Chung 1st Road, Kaohsiung 81362, Taiwan; Faculty of Medicine, School of Medicine, National Yang Ming University, Taipei, Taiwan; Institute of Clinical Medicine, National Yang Ming University, Taipei, Taiwan.'}, {'ForeName': 'Shuo-Hsiu', 'Initials': 'SH', 'LastName': 'Hsu', 'Affiliation': 'Department of Radiology, Kaohsiung Veterans General Hospital, No. 386, Ta-Chung 1st Road, Kaohsiung 81362, Taiwan.'}, {'ForeName': 'Ping-Hong', 'Initials': 'PH', 'LastName': 'Lai', 'Affiliation': 'Department of Radiology, Kaohsiung Veterans General Hospital, No. 386, Ta-Chung 1st Road, Kaohsiung 81362, Taiwan; Faculty of Medicine, School of Medicine, National Yang Ming University, Taipei, Taiwan; Institute of Clinical Medicine, National Yang Ming University, Taipei, Taiwan. Electronic address: pinghonglai@gmail.com.'}]",Clinical imaging,['10.1016/j.clinimag.2020.05.024'] 2208,32592986,"A Phase III, randomized, double-blind, placebo-controlled, multicenter study of fruquintinib in Chinese patients with advanced nonsquamous non-small-cell lung cancer - The FALUCA study.","OBJECTIVES Fruquintinib is an orally active kinase inhibitor that selectively targets the vascular endothelial growth factor (VEGF) receptor. A Phase II trial has demonstrated a significant benefit in progression-free survival (PFS) for fruquintinib-treated patients with locally advanced/metastatic nonsquamous non-small-cell lung cancer (NSCLC) who have progressed after second-line chemotherapy. This Phase III trial is a randomized, double-blind, multicenter trial to confirm fruquintinib's efficacy in the same patient population. MATERIALS AND METHODS From December 2015 to February 2018, 730 patients were screened, of whom 527 were enrolled into the study. Participants were randomized 2:1 to receive fruquintinib (n = 354) or placebo (n = 173) once daily for 3 weeks on-treatment, and 1 week off-treatment. Patients were stratified according to epidermal growth factor receptor mutation status and prior use of VEGF inhibitors. Primary endpoint was overall survival (OS). RESULTS Median OS was 8.9 months for the fruquintinib group and 10.4 months for placebo group (hazard ratio [HR] 1.02; 95 % confidence interval [CI], 0.82-1.28; P = 0.841), with median PFS of 3.7 months and 1.0 months, respectively (HR 0.34; 95 % CI, 0.28-0.43; P < 0.001). Objective response rate and disease control rate were 13.8 % and 66.7 % for fruquintinib, and 0.6 % and 24.9 % for placebo, respectively (P < 0.001). Hypertension was the most frequent treatment-emergent adverse event (≥grade 3) observed in fruquintinib-treated patients (21.0 %). Post hoc analysis revealed that fruquintinib prolonged the median OS for patients who did not receive subsequent antitumor therapy: 7.0 months versus 5.1 months for placebo (HR 0.65; 95 % CI, 0.46-0.91; P = 0.012). Patients receiving fruquintinib also reported improvements in quality of life for most functional scales measured by EORTC QLQ-C30 and LC13 questionnaires. CONCLUSION Although the study did not meet its primary endpoint, fruquintinib could be effective in combination with other agents for the treatment of patients with NSCLC who have failed second-line chemotherapy.",2020,"Patients receiving fruquintinib also reported improvements in quality of life for most functional scales measured by EORTC QLQ-C30 and LC13 questionnaires. ","['patients with NSCLC who have failed second-line chemotherapy', 'Chinese patients with advanced nonsquamous non-small-cell lung cancer ', 'From December 2015 to February 2018, 730 patients were screened, of whom 527 were enrolled into the study', 'same patient population', 'fruquintinib-treated patients with locally advanced/metastatic nonsquamous non-small-cell lung cancer (NSCLC) who have progressed after second-line chemotherapy']",['placebo'],"['Objective response rate and disease control rate', 'Median OS', 'Hypertension', 'fruquintinib prolonged the median OS', 'quality of life for most functional scales measured by EORTC QLQ-C30 and LC13 questionnaires', 'progression-free survival (PFS', 'overall survival (OS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C4517805', 'cui_str': '527'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",730.0,0.694568,"Patients receiving fruquintinib also reported improvements in quality of life for most functional scales measured by EORTC QLQ-C30 and LC13 questionnaires. ","[{'ForeName': 'Shun', 'Initials': 'S', 'LastName': 'Lu', 'Affiliation': 'Shanghai Lung Cancer Center, Shanghai Chest Hospital, Jiao Tong University, China. Electronic address: shunlu@sjtu.edu.cn.'}, {'ForeName': 'Gongyan', 'Initials': 'G', 'LastName': 'Chen', 'Affiliation': 'Harbin Medical University Cancer Hospital, China.'}, {'ForeName': 'Yuping', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'Jinan Central Hospital, China.'}, {'ForeName': 'Sanyuan', 'Initials': 'S', 'LastName': 'Sun', 'Affiliation': 'XuZhou Central Hospital, China.'}, {'ForeName': 'Jianhua', 'Initials': 'J', 'LastName': 'Chang', 'Affiliation': 'Fudan University Shanghai Cancer Center, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Yao', 'Affiliation': ""The First Affiliated Hospital of Xi'an Jiaotong University, China.""}, {'ForeName': 'Zhendong', 'Initials': 'Z', 'LastName': 'Chen', 'Affiliation': 'The Second Hospital of Anhui Medical University, China.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Ye', 'Affiliation': 'Xiamen Key Laboratory of Antitumor Drug Transformation Research, The First Affiliated Hospital of Xiamen University, China.'}, {'ForeName': 'Junguo', 'Initials': 'J', 'LastName': 'Lu', 'Affiliation': 'Nantong Tumor Hospital, China.'}, {'ForeName': 'Jianhua', 'Initials': 'J', 'LastName': 'Shi', 'Affiliation': 'Linyi Cancer Hospital, China.'}, {'ForeName': 'Jianxing', 'Initials': 'J', 'LastName': 'He', 'Affiliation': 'The First Affiliated Hospital of Guangzhou Medical University, China.'}, {'ForeName': 'Xiaoqing', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': ""The Fifth Medical Center, General Hospital of the People's Liberation Army, China.""}, {'ForeName': 'Yiping', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Zhejiang Cancer Hospital, China.'}, {'ForeName': 'Zhihua', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'Jiangxi Cancer Hospital, China.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Fang', 'Affiliation': 'Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital & Institute, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Cheng', 'Affiliation': 'Jilin Cancer Hospital, China.'}, {'ForeName': 'Chunhong', 'Initials': 'C', 'LastName': 'Hu', 'Affiliation': 'The Second Xiangya Hospital of Central South University, China.'}, {'ForeName': 'Weidong', 'Initials': 'W', 'LastName': 'Mao', 'Affiliation': ""Jiangyin People's Hospital, China.""}, {'ForeName': 'Yanping', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': 'Hubei Cancer Hospital, China.'}, {'ForeName': 'Youling', 'Initials': 'Y', 'LastName': 'Gong', 'Affiliation': 'West China Hospital of Sichuan University, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Shan', 'Affiliation': 'Xinjiang Cancer Hospital, China.'}, {'ForeName': 'Zhixiong', 'Initials': 'Z', 'LastName': 'Yang', 'Affiliation': 'Affiliated Hospital of Guangdong Medical University, China.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Song', 'Affiliation': 'Jinling Hospital, Nanjing University School of Medicine, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'The First Hospital of Jilin University, China.'}, {'ForeName': 'Chong', 'Initials': 'C', 'LastName': 'Bai', 'Affiliation': 'Shanghai Changhai Hospital, China.'}, {'ForeName': 'Buhai', 'Initials': 'B', 'LastName': 'Wang', 'Affiliation': ""Northern Jiangsu People's Hospital, China.""}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Ma', 'Affiliation': 'Liaoning Cancer Hospital, China.'}, {'ForeName': 'Zhendong', 'Initials': 'Z', 'LastName': 'Zheng', 'Affiliation': 'General Hospital of Northern Theater Command, China.'}, {'ForeName': 'Mingfang', 'Initials': 'M', 'LastName': 'Liu', 'Affiliation': 'General Hospital of Ningxia Medical University, China.'}, {'ForeName': 'Zhijun', 'Initials': 'Z', 'LastName': 'Jie', 'Affiliation': ""The Fifth People's Hospital of Shanghai, China.""}, {'ForeName': 'Lejie', 'Initials': 'L', 'LastName': 'Cao', 'Affiliation': 'The First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China, China.'}, {'ForeName': 'Wangjun', 'Initials': 'W', 'LastName': 'Liao', 'Affiliation': 'Nanfang Hospital of Southern Medical University, China.'}, {'ForeName': 'Hongming', 'Initials': 'H', 'LastName': 'Pan', 'Affiliation': 'Sir Run Run Shaw Hospital Affiliated with School of Medicine, Zhejiang University, China.'}, {'ForeName': 'Dongning', 'Initials': 'D', 'LastName': 'Huang', 'Affiliation': 'The Fourth Affiliated Hospital of Guangxi Medical University, China.'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Tongji Hospital, Tongji Medical College of Hust, China.'}, {'ForeName': 'Jinji', 'Initials': 'J', 'LastName': 'Yang', 'Affiliation': ""Guandong Provincial People's Hospital, China.""}, {'ForeName': 'Shukui', 'Initials': 'S', 'LastName': 'Qin', 'Affiliation': ""People's Liberation Army Cancer Center of Nanjing Jinling Hospital, China.""}, {'ForeName': 'Shenglin', 'Initials': 'S', 'LastName': 'Ma', 'Affiliation': ""Hangzhou First People's Hospital, China.""}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Liang', 'Affiliation': 'Peking University Third Hospital, China.'}, {'ForeName': 'Zhe', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'Beijing Chest Hospital, Capital Medical University, China.'}, {'ForeName': 'Jianying', 'Initials': 'J', 'LastName': 'Zhou', 'Affiliation': 'The First Affiliated Hospital, Zhejiang University, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Tao', 'Affiliation': 'The First Affiliated Hospital of Soochow University, China.'}, {'ForeName': 'Yijiang', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': 'Hainan General Hospital, China.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Qiu', 'Affiliation': 'The First Affiliated Hospital of Nanchang University, China.'}, {'ForeName': 'Yunchao', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': 'Yunnan Cancer Hospital, China.'}, {'ForeName': 'Sha', 'Initials': 'S', 'LastName': 'Guan', 'Affiliation': 'Hutchison MediPharma, Shanghai, China.'}, {'ForeName': 'Mengye', 'Initials': 'M', 'LastName': 'Peng', 'Affiliation': 'Hutchison MediPharma, Shanghai, China.'}, {'ForeName': 'Weiguo', 'Initials': 'W', 'LastName': 'Su', 'Affiliation': 'Hutchison MediPharma, Shanghai, China.'}]","Lung cancer (Amsterdam, Netherlands)",['10.1016/j.lungcan.2020.06.016'] 2209,32592995,Proactive Integrated Consultation-Liaison Psychiatry: A new service model for the psychiatric care of general hospital inpatients.,"OBJECTIVE To describe a new service model for the psychiatric care of general hospital inpatients, called Proactive Integrated Consultation-Liaison Psychiatry ('Proactive Integrated Psychological Medicine' in the UK). METHOD The new service model was developed especially for general hospital inpatient populations with multimorbidity, such as older medical inpatients. Its design was informed by the published literature and the clinical experience of C-L psychiatrists. It was operationalized by a process of iterative piloting. RESULTS The rationale for the new model and the principles underpinning it are outlined. Details of how to implement it, including a service manual and associated workbook, are provided. The training of clinicians to deliver it is described. The effectiveness and cost-effectiveness of this new service model is being evaluated. Whilst we have found it feasible to deliver and well-accepted by ward teams, potential challenges to its wider implementation are discussed. CONCLUSION Proactive Integrated Consultation-Liaison Psychiatry (PICLP) is a fusion of proactive consultation and integrated care, operationalized in a field-tested service manual. Initial experience indicates that it is feasible to deliver. Its effectiveness and cost effectiveness for older patients on acute medical wards is currently being evaluated in a large multicentre randomized controlled trial (The HOME Study).",2020,"The new service model was developed especially for general hospital inpatient populations with multimorbidity, such as older medical inpatients.","['general hospital inpatient populations with multimorbidity, such as older medical inpatients', ""general hospital inpatients, called Proactive Integrated Consultation-Liaison Psychiatry ('Proactive Integrated Psychological Medicine' in the UK"", 'general hospital inpatients', 'older patients on acute medical wards']","['Proactive Integrated Consultation-Liaison Psychiatry (PICLP', 'Proactive Integrated Consultation-Liaison Psychiatry']",['effectiveness and cost-effectiveness'],"[{'cui': 'C0020008', 'cui_str': 'Hospitals, General'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C1535889', 'cui_str': 'Multimorbidity'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C1305702', 'cui_str': 'Ward'}]","[{'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}]",,0.0145088,"The new service model was developed especially for general hospital inpatient populations with multimorbidity, such as older medical inpatients.","[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Sharpe', 'Affiliation': 'Psychological Medicine Research, University of Oxford Department of Psychiatry, Warneford Hospital, Oxford, UK. Electronic address: michael.sharpe@psych.ox.ac.uk.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Toynbee', 'Affiliation': 'Psychological Medicine Research, University of Oxford Department of Psychiatry, Warneford Hospital, Oxford, UK.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Walker', 'Affiliation': 'Psychological Medicine Research, University of Oxford Department of Psychiatry, Warneford Hospital, Oxford, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': 'Psychological Medicine Research, University of Oxford Department of Psychiatry, Warneford Hospital, Oxford, UK.'}]",General hospital psychiatry,['10.1016/j.genhosppsych.2020.06.005'] 2210,32593255,[Treatment of torpid trophic ulcers in patients of the older age group.],"Chronic ulcers or non-healing ulcers are more common in the elderly (20 out of 1 000 people), whose age is closer to 80 years. The application of the principles of regenerative medicine, actively developing, in the treatment of such diseases, is based on the use of both autologous blood derivatives and autologous mononuclear cells. Objective: to evaluate the effectiveness of the use of plasma enriched with platelets in the treatment of torpid ulcers of the lower extremities in patients of the older age group. A prospective, randomized clinical trial was conducted in 80 patients. According to preliminary calculations, it has been shown that the combination of traditional treatment with the introduction of plasma enriched with platelets leads to accelerated healing of ulcers.",2020,"Chronic ulcers or non-healing ulcers are more common in the elderly (20 out of 1 000 people), whose age is closer to 80 years.","['80 patients', 'patients of the older age group', 'torpid ulcers of the lower extremities in patients of the older age group']",[],['Chronic ulcers or non-healing ulcers'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231337', 'cui_str': 'Senility'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0023380', 'cui_str': 'Lethargy'}, {'cui': 'C0041582', 'cui_str': 'Ulcer'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}]",[],"[{'cui': 'C0333297', 'cui_str': 'Chronic ulcer'}, {'cui': 'C0205301', 'cui_str': 'Non-healed'}, {'cui': 'C0041582', 'cui_str': 'Ulcer'}]",1000.0,0.0160628,"Chronic ulcers or non-healing ulcers are more common in the elderly (20 out of 1 000 people), whose age is closer to 80 years.","[{'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Smagin', 'Affiliation': 'Research Institute of Clinical and Experimental Lymphology - Branch of the Institute of Cytology and Genetics, Siberian Branch of Russian Academy of Sciences, 2 Timakova str., Novosibirsk 630060, Russian Federation, e-mail: msa85@inbox.ru.'}, {'ForeName': 'O A', 'Initials': 'OA', 'LastName': 'Shumkov', 'Affiliation': 'Research Institute of Clinical and Experimental Lymphology - Branch of the Institute of Cytology and Genetics, Siberian Branch of Russian Academy of Sciences, 2 Timakova str., Novosibirsk 630060, Russian Federation, e-mail: msa85@inbox.ru.'}, {'ForeName': 'M I', 'Initials': 'MI', 'LastName': 'Soluianov', 'Affiliation': 'Research Institute of Clinical and Experimental Lymphology - Branch of the Institute of Cytology and Genetics, Siberian Branch of Russian Academy of Sciences, 2 Timakova str., Novosibirsk 630060, Russian Federation, e-mail: msa85@inbox.ru.'}, {'ForeName': 'A U', 'Initials': 'AU', 'LastName': 'Demura', 'Affiliation': 'Research Institute of Clinical and Experimental Lymphology - Branch of the Institute of Cytology and Genetics, Siberian Branch of Russian Academy of Sciences, 2 Timakova str., Novosibirsk 630060, Russian Federation, e-mail: msa85@inbox.ru.'}, {'ForeName': 'A A', 'Initials': 'AA', 'LastName': 'Smagin', 'Affiliation': 'Research Institute of Clinical and Experimental Lymphology - Branch of the Institute of Cytology and Genetics, Siberian Branch of Russian Academy of Sciences, 2 Timakova str., Novosibirsk 630060, Russian Federation, e-mail: msa85@inbox.ru.'}, {'ForeName': 'A P', 'Initials': 'AP', 'LastName': 'Lykov', 'Affiliation': 'Research Institute of Clinical and Experimental Lymphology - Branch of the Institute of Cytology and Genetics, Siberian Branch of Russian Academy of Sciences, 2 Timakova str., Novosibirsk 630060, Russian Federation, e-mail: msa85@inbox.ru.'}, {'ForeName': 'V V', 'Initials': 'VV', 'LastName': 'Nimaev', 'Affiliation': 'Research Institute of Clinical and Experimental Lymphology - Branch of the Institute of Cytology and Genetics, Siberian Branch of Russian Academy of Sciences, 2 Timakova str., Novosibirsk 630060, Russian Federation, e-mail: msa85@inbox.ru.'}]",Advances in gerontology = Uspekhi gerontologii,[] 2211,32596729,Effect of increased potassium intake on the renin-angiotensin-aldosterone system and subcutaneous resistance arteries: a randomized crossover study.,"BACKGROUND Increased potassium intake lowers blood pressure (BP) in hypertensive patients. The underlying mechanism is not fully understood but must be complex because increased potassium intake elevates circulating concentrations of the BP-raising hormone aldosterone. METHODS In a randomized placebo-controlled crossover study in 25 normotensive men, we investigated the effect of 4 weeks of potassium supplement (90 mmol/day) compared with 4 weeks of placebo on the renin-angiotensin-aldosterone system (RAAS), urine composition and 24-h ambulatory BP. Vascular function was also assessed through wire myograph experiments on subcutaneous resistance arteries from gluteal fat biopsies. RESULTS Higher potassium intake increased urinary potassium excretion (144.7 ± 28.7 versus 67.5 ± 25.5 mmol/24-h; P < 0.0001) and plasma concentrations of potassium (4.3 ± 0.2 versus 4.0 ± 0.2 mmol/L; P = 0.0002), renin {mean 16 [95% confidence interval (CI) 12-23] versus 11 [5-16] mIU/L; P = 0.0047}, angiotensin II [mean 10.0 (95% CI 6.2-13.0) versus 6.1 (4.0-10.0) pmol/L; P = 0.0025] and aldosterone [mean 440 (95% CI 336-521) versus 237 (173-386) pmol/L; P < 0.0001]. Despite RAAS activation, systolic BP (117.6 ± 5.8 versus 118.2 ± 5.2 mmHg; P = 0.48) and diastolic BP (70.8 ± 6.2 versus 70.8 ± 6.3 mmHg; P = 0.97) were unchanged. In the wire myograph experiments, higher potassium intake did not affect endothelial function as assessed by acetylcholine [logarithmically transformed half maximal effective concentration (pEC50): 7.66 ± 0.95 versus 7.59 ± 0.85; P = 0.86] and substance P (pEC50: 8.42 ± 0.77 versus 8.41 ± 0.89; P = 0.97) or vascular smooth muscle cell reactivity as assessed by angiotensin II (pEC50: 9.01 ± 0.86 versus 9.02 ± 0.59; P = 0.93) and sodium nitroprusside (pEC50: 7.85 ± 1.07 versus 8.25 ± 1.32; P = 0.25) but attenuated the vasodilatory response of retigabine (pEC50: 7.47 ± 1.16 versus 8.14 ± 0.90; P = 0.0084), an activator of Kv7 channels. CONCLUSIONS Four weeks of increased potassium intake activates the RAAS in normotensive men without changing BP and this is not explained by improved vasodilatory responses ex vivo.",2020,Four weeks of increased potassium intake activates the RAAS in normotensive men without changing BP and this is not explained by improved vasodilatory responses ex vivo.,"['normotensive men', 'hypertensive patients', '25 normotensive men']","['potassium supplement', 'placebo']","['renin-angiotensin-aldosterone system (RAAS), urine composition and 24-h ambulatory BP', 'plasma concentrations of potassium', 'endothelial function', 'higher potassium intake', 'renin-angiotensin-aldosterone system and subcutaneous resistance arteries', 'diastolic BP', 'Vascular function', 'blood pressure (BP', 'Despite RAAS activation, systolic BP', 'vascular smooth muscle cell reactivity', 'urinary potassium excretion', 'aldosterone', 'vasodilatory response of retigabine']","[{'cui': 'C2712122', 'cui_str': 'Normal blood pressure'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0304475', 'cui_str': 'Potassium supplement'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0086907', 'cui_str': 'Renin-Angiotensin-Aldosterone System'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0855316', 'cui_str': 'Blood pressure ambulatory'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0032821', 'cui_str': 'Potassium'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0856882', 'cui_str': 'Potassium increased'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0232337', 'cui_str': 'Vascular function'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0026844', 'cui_str': 'Vascular Smooth Muscle'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0002006', 'cui_str': 'Aldosterone'}, {'cui': 'C0530684', 'cui_str': 'ezogabine'}]",25.0,0.251082,Four weeks of increased potassium intake activates the RAAS in normotensive men without changing BP and this is not explained by improved vasodilatory responses ex vivo.,"[{'ForeName': 'Rasmus', 'Initials': 'R', 'LastName': 'Dreier', 'Affiliation': 'Department of Medicine, Amager Hvidovre Hospital in Glostrup, University of Copenhagen, Glostrup, Denmark.'}, {'ForeName': 'Bahareh', 'Initials': 'B', 'LastName': 'Abdolalizadeh', 'Affiliation': 'Department of Drug Design and Pharmacology, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Camilla L', 'Initials': 'CL', 'LastName': 'Asferg', 'Affiliation': 'Department of Medicine, Amager Hvidovre Hospital in Glostrup, University of Copenhagen, Glostrup, Denmark.'}, {'ForeName': 'Lisbet R', 'Initials': 'LR', 'LastName': 'Hölmich', 'Affiliation': 'Department of Plastic Surgery, Herlev Gentofte Hospital, University of Copenhagen, Herlev, Denmark.'}, {'ForeName': 'Niels H', 'Initials': 'NH', 'LastName': 'Buus', 'Affiliation': 'Department of Renal Medicine, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Julie L', 'Initials': 'JL', 'LastName': 'Forman', 'Affiliation': 'Department of Public Health, Section of Biostatistics, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Ulrik B', 'Initials': 'UB', 'LastName': 'Andersen', 'Affiliation': 'Department of Clinical Physiology, Nuclear Medicine and PET, Rigshospitalet Glostrup, University of Copenhagen, Glostrup, Denmark.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Egfjord', 'Affiliation': 'Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Majid', 'Initials': 'M', 'LastName': 'Sheykhzade', 'Affiliation': 'Department of Drug Design and Pharmacology, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Jørgen L', 'Initials': 'JL', 'LastName': 'Jeppesen', 'Affiliation': 'Department of Medicine, Amager Hvidovre Hospital in Glostrup, University of Copenhagen, Glostrup, Denmark.'}]","Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association",['10.1093/ndt/gfaa114'] 2212,32596764,Efficacy of stem cell allograft in maxillary sinus bone regeneration: a randomized controlled clinical and blinded histomorphometric study.,"PURPOSE This study aimed to evaluate the quality and quantity of newly generated bone in the maxillary sinus grafted with stem cell-based allograft material. METHODS This study was a single site, prospective, blinded, randomized, and controlled clinical trial. Eleven subjects with 18 edentulous posterior maxillary sites requiring sinus augmentation for delayed implant placement using a lateral window approach were enrolled. At the time of sinus augmentation, test sinus was grafted with stem cell-based allograft (Osteocel Plus; NuVasive Therapeutics), while the control sinus was grafted with conventional cortico-cancellous allograft (alloOss; ACE Surgical). Cone beam computer tomography (CBCT) scan was taken before and 14 weeks post-sinus augmentation procedure, i.e., 2 weeks before implant placement. Thirty-six trephined core bone biopsies were harvested from the anterior and posterior grafted lateral-window osteotomy sites at the time of implant placement. RESULTS The results showed a statistically significant difference in the vital bone percentage between the test and the control groups at the posterior grafted sites (p = 0.03). There was no significant difference in the percentage of vital bone between the anterior and posterior grafted sites within the test and control groups (p > .05). The CBCT analysis showed that the maxillary sinuses at the posterior grafted sites were statistically wider than those at the anterior grafted sites in both groups (p < .05). CONCLUSIONS Different allograft bone materials can be used in the maxillary sinus augmentation procedures. Stem cell allograft has more osteogenic potential with a better outcome in the wide posterior sinus.",2020,There was no significant difference in the percentage of vital bone between the anterior and posterior grafted sites within the test and control groups (p > .05).,"['maxillary sinus bone regeneration', 'Eleven subjects with 18 edentulous posterior maxillary sites requiring sinus augmentation for delayed implant placement using a lateral window approach were enrolled']","['Cone beam computer tomography (CBCT) scan', 'stem cell allograft', 'stem cell-based allograft material']","['vital bone percentage', 'percentage of vital bone', 'quality and quantity']","[{'cui': 'C0024957', 'cui_str': 'Maxillary sinus structure'}, {'cui': 'C0005972', 'cui_str': 'Bone Regeneration'}, {'cui': 'C0026644', 'cui_str': 'Edentulous'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0024947', 'cui_str': 'Bone structure of maxilla'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C2236586', 'cui_str': 'Sinus augmentation'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0557702', 'cui_str': 'Window'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}]","[{'cui': 'C0206428', 'cui_str': 'Cone of retina'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0040395', 'cui_str': 'Diagnostic tomography'}, {'cui': 'C0034606', 'cui_str': 'Nuclear medicine imaging procedure'}, {'cui': 'C0038250', 'cui_str': 'Stem cell'}, {'cui': 'C0040739', 'cui_str': 'Allogeneic transplantation'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0520510', 'cui_str': 'Material'}]","[{'cui': 'C0442732', 'cui_str': 'Vital'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C1265611', 'cui_str': 'Quantity'}]",11.0,0.0295757,There was no significant difference in the percentage of vital bone between the anterior and posterior grafted sites within the test and control groups (p > .05).,"[{'ForeName': 'Josh', 'Initials': 'J', 'LastName': 'Whitt', 'Affiliation': 'University of Kentucky College of Dentistry, Lexington, KY, USA.'}, {'ForeName': 'Mohanad', 'Initials': 'M', 'LastName': 'Al-Sabbagh', 'Affiliation': 'Division of Periodontology, University of Kentucky College of Dentistry, Lexington, KY, USA.'}, {'ForeName': 'Dolphus', 'Initials': 'D', 'LastName': 'Dawson', 'Affiliation': 'University of Kentucky College of Dentistry, Lexington, KY, USA.'}, {'ForeName': 'Ehab', 'Initials': 'E', 'LastName': 'Shehata', 'Affiliation': 'Division of Oral and Maxillofacial Surgery, University of Kentucky College of Dentistry, Lexington, KY, USA.'}, {'ForeName': 'Moly', 'Initials': 'M', 'LastName': 'Housley-Smith', 'Affiliation': 'Division of Oral and Maxillofacial Surgery, University of Kentucky College of Dentistry, Lexington, KY, USA.'}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Tezanos', 'Affiliation': 'Department of Statistics, University of Kentucky College of Dentistry, Lexington, KY, USA.'}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Kutkut', 'Affiliation': 'Division of Prosthodontics, University of Kentucky College of Dentistry, 800 Rose St. D646, Lexington, KY, 40536, USA. ahmad.kutkut@uky.edu.'}]",International journal of implant dentistry,['10.1186/s40729-020-00222-w'] 2213,32596783,Multicenter phase III trial of S-1 and cisplatin versus S-1 and oxaliplatin combination chemotherapy for first-line treatment of advanced gastric cancer (SOPP trial).,"BACKGROUND In East Asia, S-1 plus cisplatin (SP) is one of the standard first-line chemotherapy regimens for metastatic or recurrent gastric cancer (MRGC). Oxaliplatin is generally less toxic and more convenient to administer than cisplatin. PATIENTS AND METHODS This was a multicenter, phase III study assessing whether S-1/oxaliplatin (SOX) was non-inferior/superior to SP in terms of progression-free survival (PFS). Patients with MRGC were randomized 1:1 to receive either SOX (S-1 80 mg/m 2 /day on days 1-14; oxaliplatin 130 mg/m 2 on day 1; every 3 weeks) or SP (S-1 80 mg/m 2 /day on days 1-14; cisplatin 60 mg/m 2 on day 1; every 3 weeks [SP3]). RESULTS Between October 2012 and October 2014, 338 patients were randomized. The median age was 56 years, and 51% of patients had measurable lesions. SOX was significantly non-inferior but not superior to SP3 in terms of PFS [median 5.6 versus 5.7 months; hazard ratio (HR) 0.85; 95% confidence interval (CI) 0.67-1.07]. In patients with measurable disease, objective response rates were similar between SOX and SP3 (58% versus 60%). Overall, the survival in both groups did not differ (median 12.9 versus 11.4 months; HR 0.86; 95% CI 0.66-1.11). Treatment was well tolerated in both arms. Anemia, leucopenia, neutropenia, febrile neutropenia, and oral mucositis were more common with SP3. In contrast, thrombocytopenia, nausea, vomiting, and peripheral neuropathy were more common with SOX. CONCLUSIONS SOX was non-inferior to SP3. The two regimens were well tolerated with different toxicity profiles. The SOX regimen can be recommended as a first-line treatment for MRGC. TRIAL REGISTRATION ClinicalTrials.gov: NCT01671449.",2020,"In patients with measurable disease, objective response rates were similar between SOX and SP3 (58% versus 60%).","['advanced gastric cancer (SOPP trial', 'Patients with MRGC', 'metastatic or recurrent gastric cancer (MRGC', 'Between October 2012 and October 2014, 338 patients were randomized']","['SOX (S-1 80\xa0mg/m 2 /day on days 1-14; oxaliplatin 130\xa0mg/m 2 on day 1; every 3\xa0weeks) or SP (S-1 80\xa0mg/m 2 /day on days 1-14; cisplatin 60\xa0mg/m 2 on day 1; every 3\xa0weeks [SP3', 'S-1/oxaliplatin (SOX', 'S-1 and cisplatin versus S-1 and oxaliplatin combination chemotherapy', 'Oxaliplatin', 'S-1 plus cisplatin (SP']","['tolerated', 'thrombocytopenia, nausea, vomiting, and peripheral neuropathy', 'survival', 'objective response rates', 'progression-free survival (PFS', 'tolerated with different toxicity profiles', 'Anemia, leucopenia, neutropenia, febrile neutropenia, and oral mucositis', 'SOX']","[{'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0024623', 'cui_str': 'Malignant tumor of stomach'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0278502', 'cui_str': 'Gastric cancer recurrent'}]","[{'cui': 'C0879262', 'cui_str': 'S 1 (combination)'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0585333', 'cui_str': 'Triweekly'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0348086', 'cui_str': 'SP3'}, {'cui': 'C0013218', 'cui_str': 'Combination Drug Therapy'}]","[{'cui': 'C0040034', 'cui_str': 'Thrombocytopenic disorder'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C1869037', 'cui_str': 'Peripheral neuropathy (SMQ)'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0023530', 'cui_str': 'Leukopenia'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0746883', 'cui_str': 'Febrile neutropenia'}, {'cui': 'C0038362', 'cui_str': 'Stomatitis'}]",338.0,0.168688,"In patients with measurable disease, objective response rates were similar between SOX and SP3 (58% versus 60%).","[{'ForeName': 'Keun-Wook', 'Initials': 'KW', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, Republic of Korea.'}, {'ForeName': 'Ik-Joo', 'Initials': 'IJ', 'LastName': 'Chung', 'Affiliation': 'Department of Hematology-Oncology, Chonnam National University Hwasun Hospital, Chonnam National University Medical School, Hwasun, Republic of Korea.'}, {'ForeName': 'Min-Hee', 'Initials': 'MH', 'LastName': 'Ryu', 'Affiliation': 'Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea. miniryu@amc.seoul.kr.'}, {'ForeName': 'Young Iee', 'Initials': 'YI', 'LastName': 'Park', 'Affiliation': 'Center for Gastric Cancer, Research Institute and Hospital, National Cancer Center, Goyang, Republic of Korea. youngiee@ncc.re.kr.'}, {'ForeName': 'Byung-Ho', 'Initials': 'BH', 'LastName': 'Nam', 'Affiliation': 'Department of Cancer Control and Policy, Graduate School of Cancer Science and Policy, National Cancer Center, Goyang, Republic of Korea.'}, {'ForeName': 'Ho-Suk', 'Initials': 'HS', 'LastName': 'Oh', 'Affiliation': 'Department of Internal Medicine, Gangneung Asan Hospital, University of Ulsan College of Medicine, Gangneung, Republic of Korea.'}, {'ForeName': 'Kyung Hee', 'Initials': 'KH', 'LastName': 'Lee', 'Affiliation': 'Department of Medicine, Yeungnam University College of Medicine, Daegu, Republic of Korea.'}, {'ForeName': 'Hye Sook', 'Initials': 'HS', 'LastName': 'Han', 'Affiliation': 'Department of Internal Medicine, College of Medicine, Chungbuk National University, Cheongju, Republic of Korea.'}, {'ForeName': 'Bong-Gun', 'Initials': 'BG', 'LastName': 'Seo', 'Affiliation': 'Department of Internal Medicine, Dongnam Institute of Radiological and Medical Sciences, Busan, Republic of Korea.'}, {'ForeName': 'Jae-Cheol', 'Initials': 'JC', 'LastName': 'Jo', 'Affiliation': 'Department of Internal Medicine, Ulsan University Hospital, University of Ulsan College of Medicine, Ulsan, Republic of Korea.'}, {'ForeName': 'Hyo Rak', 'Initials': 'HR', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, Korea Cancer Center Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Jin Won', 'Initials': 'JW', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, Republic of Korea.'}, {'ForeName': 'Sook Ryun', 'Initials': 'SR', 'LastName': 'Park', 'Affiliation': 'Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Sang Hee', 'Initials': 'SH', 'LastName': 'Cho', 'Affiliation': 'Department of Hematology-Oncology, Chonnam National University Hwasun Hospital, Chonnam National University Medical School, Hwasun, Republic of Korea.'}, {'ForeName': 'Yoon-Koo', 'Initials': 'YK', 'LastName': 'Kang', 'Affiliation': 'Department of Oncology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Gastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association,['10.1007/s10120-020-01101-4'] 2214,32596788,Efficacy and acceptability of a second dose of ecological executive skills training for children with ADHD: a randomized controlled study and follow-up.,"To explore the efficacy and acceptability of a second dose of the 12-session ecological executive skills training (EEST) 1 year after the initial training in children with ADHD. A total of 97 children (aged 6-12) with ADHD who finished the first dose for about 1 year were recruited in the current study. 70 children who agreed to participate the second dose were randomized to the second dose or waitlist group. Both groups were followed up 1 year after the second dose. Executive function, core symptoms were assessed at the time of pre-intervention first dose, pre-intervention second dose, post-intervention second dose and follow-up 1 year after second dose (phase 0-3). For the immediate efficacy, the improvements in the second dose group were greater than the waitlist group on planning by Stockings of Cambridge and delay aversion by Cambridge gambling task (P = 0.02-0.04, η 2  = 0.07-0.08). The parent rating of symptoms assessed by ADHD-RS-IV of the second dose group were also greater than the waitlist group rated by self-report. For long term efficacy, Linear mixed model indicated that there was significant time effect for both groups between phase 3 and phase 1, phase 1 and phase 0 on Behavior Rating Scales of Executive Function and ADHD-RS-IV (F = 2.849-21.560, P = 0.001-0.048). The compliance rate was 94.3% for the second dose group and 49% for waitlist group. A second dose of EEST program might bring further efficacy of EF and core symptoms for children with ADHD and it was well accepted.",2020,"(F = 2.849-21.560, P = 0.001-0.048).","['children with ADHD', '70 children who agreed to participate the second dose', '97 children (aged 6-12) with ADHD who finished the first dose for about 1\xa0year were recruited in the current study']","['ecological executive skills training', '12-session ecological executive skills training (EEST', 'EEST program']","['Executive function, core symptoms', 'Efficacy and acceptability', 'Behavior Rating Scales of Executive Function and ADHD-RS-IV', 'efficacy and acceptability', 'compliance rate']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C1706059', 'cui_str': 'Finish'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0559197', 'cui_str': 'Skills training'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0475483', 'cui_str': 'Behavior rating scale'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}]",70.0,0.0229869,"(F = 2.849-21.560, P = 0.001-0.048).","[{'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Qian', 'Affiliation': 'Peking University Sixth Hospital (Institute of Mental Health), National Clinical Research Center for Mental Disorders and NHC Key Laboratory of Mental Health (Peking University Sixth Hospital), 51 HuayuanBei Road, Beijing, 100191, China.'}, {'ForeName': 'Zili', 'Initials': 'Z', 'LastName': 'Fan', 'Affiliation': 'Peking University Sixth Hospital (Institute of Mental Health), National Clinical Research Center for Mental Disorders and NHC Key Laboratory of Mental Health (Peking University Sixth Hospital), 51 HuayuanBei Road, Beijing, 100191, China.'}, {'ForeName': 'Bingling', 'Initials': 'B', 'LastName': 'Gao', 'Affiliation': 'Peking University Sixth Hospital (Institute of Mental Health), National Clinical Research Center for Mental Disorders and NHC Key Laboratory of Mental Health (Peking University Sixth Hospital), 51 HuayuanBei Road, Beijing, 100191, China.'}, {'ForeName': 'Sibley', 'Initials': 'S', 'LastName': 'Margaret', 'Affiliation': ""Center for Child Health, Behavior, and Development, Seattle Children's Hospital, University of Washington, 2001 8th Ave., Suite 400, Seattle, WA, 98121, USA.""}, {'ForeName': 'Qingjiu', 'Initials': 'Q', 'LastName': 'Cao', 'Affiliation': 'Peking University Sixth Hospital (Institute of Mental Health), National Clinical Research Center for Mental Disorders and NHC Key Laboratory of Mental Health (Peking University Sixth Hospital), 51 HuayuanBei Road, Beijing, 100191, China.'}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Li', 'Affiliation': 'Peking University Sixth Hospital (Institute of Mental Health), National Clinical Research Center for Mental Disorders and NHC Key Laboratory of Mental Health (Peking University Sixth Hospital), 51 HuayuanBei Road, Beijing, 100191, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': 'Peking University Sixth Hospital (Institute of Mental Health), National Clinical Research Center for Mental Disorders and NHC Key Laboratory of Mental Health (Peking University Sixth Hospital), 51 HuayuanBei Road, Beijing, 100191, China. yangli_pkuimh@bjmu.edu.cn.'}]",European child & adolescent psychiatry,['10.1007/s00787-020-01571-y'] 2215,32600452,Development of a multivariable improvement measure for gout.,"BACKGROUND Gout is a heterogeneous inflammatory disease with numerous clinical manifestations. A composite means to assess the impact of therapy on numerous aspects of gout could be useful. METHODS Results from patients treated with pegloticase or placebo in two randomized clinical trials and their open-label extension were assessed using a novel evidence-based Gout Multivariable Improvement Measure (GMIM) derived from previously reported criteria for remission and complete response. Improvement was defined as serum urate (sU) < 6 mg/dL and absence of flares during the preceding 3 months plus 20, 50, and 70% improvement in tophus size, patient global assessment, pain, and swollen and tender joints. RESULTS Patients treated with pegloticase manifested a significantly greater GMIM20, 50, and 70 response vs those treated with placebo (GMIM20 at 6 months 37.1% vs 0%, respectively). Higher response rates were significantly more frequent in subjects with persistent urate lowering (GMIM 58.1% at 6 months) in response to pegloticase versus those with only transient urate lowering (GMIM 7.1% at 6 months). However, when the requirement for a decrease in sU to < 6 mg/dL was omitted, a substantial percentage of subjects with transient urate lowering met the GMIM clinical criteria. A sensitivity analysis indicated that gout flares contributed minimally to the model. The response measured by GMIM persisted into the open-level extension for as long as 2 years. Finally, subjects who received placebo in the randomized control trials, but pegloticase in the open-label extension, manifested GMIM responses comparable to that noted with pegloticase-treated subjects in the randomized controlled trials. CONCLUSIONS GMIM captures changes in disease activity in response to treatment with pegloticase and may serve as an evidence-based tool for assessment of responses to other urate-lowering therapies in gout patients.",2020,Higher response rates were significantly more frequent in subjects with persistent urate lowering (GMIM 58.1% at 6 months) in response to pegloticase versus those with only transient urate lowering (GMIM 7.1% at 6 months).,['gout patients'],"['pegloticase or placebo', 'placebo']","['tophus size, patient global assessment, pain, and swollen and tender joints', 'GMIM responses', 'Higher response rates', 'serum urate (sU', 'GMIM20']","[{'cui': 'C0018099', 'cui_str': 'Gout'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C2350656', 'cui_str': 'Pegloticase'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0221248', 'cui_str': 'Tophus'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0038999', 'cui_str': 'Swelling'}, {'cui': 'C0240094', 'cui_str': 'Tenderness of joint'}, {'cui': 'C0018099', 'cui_str': 'Gout'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0202239', 'cui_str': 'Uric acid measurement'}]",,0.181673,Higher response rates were significantly more frequent in subjects with persistent urate lowering (GMIM 58.1% at 6 months) in response to pegloticase versus those with only transient urate lowering (GMIM 7.1% at 6 months).,"[{'ForeName': 'Naomi', 'Initials': 'N', 'LastName': 'Schlesinger', 'Affiliation': 'Division of Rheumatology, Department of Medicine, Rutgers Robert Wood Johnson Medical School, New Brunswick, NJ, USA.'}, {'ForeName': 'N Lawrence', 'Initials': 'NL', 'LastName': 'Edwards', 'Affiliation': 'Department of Medicine, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Anthony E', 'Initials': 'AE', 'LastName': 'Yeo', 'Affiliation': 'Yeo Analytics, LLC, Jersey City, NJ, USA.'}, {'ForeName': 'Peter E', 'Initials': 'PE', 'LastName': 'Lipsky', 'Affiliation': 'AMPEL BioSolutions, LLC, Charlottesville, VA, USA. peterlipsky@comcast.net.'}]",Arthritis research & therapy,['10.1186/s13075-020-02254-4'] 2216,32600454,"The TOTEM RRMS (Testosterone Treatment on neuroprotection and Myelin Repair in Relapsing Remitting Multiple Sclerosis) trial: study protocol for a randomized, double-blind, placebo-controlled trial.","BACKGROUND Central nervous system damage in multiple sclerosis (MS) is responsible for serious deficiencies. Current therapies are focused on the treatment of inflammation; however, there is an urgent need for innovative therapies promoting neuroregeneration, particularly myelin repair. It is demonstrated that testosterone can act through neural androgen receptors and several clinical observations stimulated an interest in the potential protective effects of testosterone treatment for MS. Here, we sought to demonstrate the effects of a testosterone supplementation in testosterone-deficient men with relapsing-remitting MS. METHODS/DESIGN This report presents the rationale and methodology of TOTEM RRMS, a French, phase 2, multicenter, randomized, placebo-controlled, and double-blind trial, which aims to prevent the progression of MS in men with low testosterone levels by administration of testosterone undecanoate, who were kept under natalizumab (Tysabri®) to overcome the anti-inflammatory effect of testosterone. Forty patients will be randomized into two groups receiving either a testosterone treatment (Nebido®) or a matching placebo. The intervention period for each group will last 66 weeks (treatment will be injected at baseline, week 6, and then every 12 weeks). The main objective is to determine the neuroprotective and remyelinating effects of testosterone using tensor diffusion imaging techniques and thalamic atrophy analyses. As secondary objectives, impacts of the testosterone supplementation will be studied using other conventional and unconventional MRI parameters and with clinical outcomes. DISCUSSION The action of testosterone is observed in different experimental autoimmune encephalomyelitis models and epidemiological studies in humans. However, despite several preclinical data and some small clinical trials in MS, clear evidence for a therapeutic effect of hormone therapy is still missing. Therefore, our goal is to demonstrate the effects of testosterone therapies in MS. As there is no effective treatment currently available on fatigue in MS, careful attention should also be paid to secondary endpoints: fatigue, cognitive functions, and other symptoms that may improve life quality. Assuming a positive outcome of the trial, this treatment could be considered as a new neuroprotective and remyelinating therapy in relapsing-remitting MS and could be applicable to other demyelinating diseases. TRIAL REGISTRATION ClinicalTrials.gov NCT03910738. Registered on 10 April 2019.",2020,The main objective is to determine the neuroprotective and remyelinating effects of testosterone using tensor diffusion imaging techniques and thalamic atrophy analyses.,"['men with low testosterone levels by administration of', 'Forty patients', 'multiple sclerosis (MS', 'testosterone-deficient men with relapsing-remitting MS']","['testosterone', 'testosterone undecanoate, who were kept under natalizumab (Tysabri®', 'testosterone treatment (Nebido®) or a matching placebo', 'TOTEM RRMS (Testosterone Treatment on neuroprotection and Myelin Repair', 'testosterone supplementation', 'placebo']",[],"[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C1295654', 'cui_str': 'Decreased testosterone level'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0039601', 'cui_str': 'Testosterone'}, {'cui': 'C0011155', 'cui_str': 'Deficiency'}, {'cui': 'C0751967', 'cui_str': 'Relapsing remitting multiple sclerosis'}]","[{'cui': 'C0039601', 'cui_str': 'Testosterone'}, {'cui': 'C0076195', 'cui_str': 'Testosterone undecanoate'}, {'cui': 'C0333118', 'cui_str': 'Retained'}, {'cui': 'C1172734', 'cui_str': 'natalizumab'}, {'cui': 'C1529600', 'cui_str': 'Tysabri'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C2713349', 'cui_str': 'Nebido'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1522002', 'cui_str': 'RRM Motif'}, {'cui': 'C0598958', 'cui_str': 'Neuron Protection'}, {'cui': 'C0026969', 'cui_str': 'Myelin'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]",[],40.0,0.549756,The main objective is to determine the neuroprotective and remyelinating effects of testosterone using tensor diffusion imaging techniques and thalamic atrophy analyses.,"[{'ForeName': 'Katline', 'Initials': 'K', 'LastName': 'Metzger-Peter', 'Affiliation': 'Centre d᾿Investigation Clinique INSERM 1434, Strasbourg, France. katline.metzger@gmail.com.'}, {'ForeName': 'Laurent Daniel', 'Initials': 'LD', 'LastName': 'Kremer', 'Affiliation': 'Departement of Neurology, Hôpital de Hautepierre, University Hospital of Strasbourg, Strasbourg, France.'}, {'ForeName': 'Gilles', 'Initials': 'G', 'LastName': 'Edan', 'Affiliation': 'Departement of Neurology, Hôpital Pontchaillou, University Hospital of Rennes, Rennes, France.'}, {'ForeName': 'Paulo', 'Initials': 'P', 'LastName': 'Loureiro De Sousa', 'Affiliation': 'Laboratory of Engineering Sciences, Computer Science and Imagery (ICube), CNRS, Institute of Biological Physics, University of Strasbourg, Strasbourg, France.'}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Lamy', 'Affiliation': 'Laboratory of Engineering Sciences, Computer Science and Imagery (ICube), CNRS, Institute of Biological Physics, University of Strasbourg, Strasbourg, France.'}, {'ForeName': 'Dominique', 'Initials': 'D', 'LastName': 'Bagnard', 'Affiliation': 'Departement of Myelin Biopathology, Neuroprotection and Therapeutic Strategies, UMR_S Inserm 1119, Strasbourg, France.'}, {'ForeName': 'Ayikoe-Guy', 'Initials': 'AG', 'LastName': 'Mensah-Nyagan', 'Affiliation': 'Departement of Myelin Biopathology, Neuroprotection and Therapeutic Strategies, UMR_S Inserm 1119, Strasbourg, France.'}, {'ForeName': 'Thibault', 'Initials': 'T', 'LastName': 'Tricard', 'Affiliation': 'Departement of Urological Surgery, Nouvel Hôpital Civil, University Hospital of Strasbourg, Strasbourg, France.'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Mathey', 'Affiliation': 'Departement of Neurology, Hôpital Central, University Hospital of Nancy, Nancy, France.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Debouverie', 'Affiliation': 'Departement of Neurology, Hôpital Central, University Hospital of Nancy, Nancy, France.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Berger', 'Affiliation': 'Departement of Neurology, Hôpital Jean Minjoz, University Hospital of Besançon, Besançon, France.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Kerbrat', 'Affiliation': 'Department of Neurology, Hôpital de Pontchaillou, University Hospital of Rennes, Rennes, France.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Meyer', 'Affiliation': 'Departement of Public Health, GMRC University Hospital of Strasbourg, Strasbourg, France.'}, {'ForeName': 'Jérôme', 'Initials': 'J', 'LastName': 'De Seze', 'Affiliation': 'Centre d᾿Investigation Clinique INSERM 1434, Strasbourg, France.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Collongues', 'Affiliation': 'Centre d᾿Investigation Clinique INSERM 1434, Strasbourg, France.'}]",Trials,['10.1186/s13063-020-04517-6'] 2217,32600474,T-tube drainage versus choledochojejunostomy in hepatolithiasis patients with sphincter of Oddi laxity: study protocol for a randomized controlled trial.,"BACKGROUND Residual and recurrent stones remain one of the most important challenges of hepatolithiasis and are reported in 20 to 50% of patients treated for this condition. To date, the two most common surgical procedures performed for hepatolithiasis are choledochojejunostomy and T-tube drainage for biliary drainage. The goal of the present study was to evaluate the therapeutic safety and perioperative and long-term outcomes of choledochojejunostomy versus T-tube drainage for hepatolithiasis patients with sphincter of Oddi laxity (SOL). METHODS/DESIGN In total, 210 patients who met the following eligibility criteria were included and were randomized to the choledochojejunostomy arm or T-tube drainage arm in a 1:1 ratio: (1) diagnosed with hepatolithiasis with SOL during surgery; (2) underwent foci removal, stone extraction and stricture correction during the operation; (3) provided written informed consent; (4) was willing to complete a 3-year follow-up; and (5) aged between 18 and 70 years. The primary efficacy endpoint of the trial will be the incidence of biliary complications (stone recurrence, biliary stricture, cholangitis) during the 3 years after surgery. The secondary outcomes will be the surgical, perioperative and long-term follow-up outcomes. DISCUSSION This is a prospective, single-centre and randomized controlled two-group parallel trial designed to demonstrate which drainage method (Roux-en-Y hepaticojejunostomy or T-tube drainage) can better reduce biliary complications (stone recurrence, biliary stricture, cholangitis) in hepatolithiasis patients with SOL. TRIAL REGISTRATION Clinical Trials.gov: NCT04218669 . Registered on 6 January 2020.",2020,"The primary efficacy endpoint of the trial will be the incidence of biliary complications (stone recurrence, biliary stricture, cholangitis) during the 3 years after surgery.","['hepatolithiasis patients with sphincter of Oddi laxity', '210 patients who met the following eligibility criteria', 'hepatolithiasis patients with SOL', 'hepatolithiasis patients with sphincter of Oddi laxity (SOL']","['choledochojejunostomy arm or T-tube drainage arm in a 1:1 ratio: (1) diagnosed with hepatolithiasis with SOL during surgery; (2) underwent foci removal, stone extraction and stricture correction during the operation; (3) provided written informed consent', 'choledochojejunostomy versus T-tube drainage', 'T-tube drainage versus choledochojejunostomy', 'drainage method (Roux-en-Y hepaticojejunostomy or T-tube drainage']","['therapeutic safety and perioperative', 'incidence of biliary complications (stone recurrence, biliary stricture, cholangitis', 'biliary complications (stone recurrence, biliary stricture, cholangitis', 'surgical, perioperative and long-term follow-up outcomes']","[{'cui': 'C0574143', 'cui_str': 'Liver calculus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0028872', 'cui_str': 'Sphincter of Oddi structure'}, {'cui': 'C0332536', 'cui_str': 'Laxity'}, {'cui': 'C4319559', 'cui_str': '210'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0008343', 'cui_str': 'Choledochojejunostomy'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0175731', 'cui_str': 'T-tube'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0574143', 'cui_str': 'Liver calculus'}, {'cui': 'C0028872', 'cui_str': 'Sphincter of Oddi structure'}, {'cui': 'C0332536', 'cui_str': 'Laxity'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0205234', 'cui_str': 'Focal'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0006736', 'cui_str': 'Calculus'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C1261287', 'cui_str': 'Stenosis'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0021430', 'cui_str': 'Informed Consent'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0585537', 'cui_str': 'Roux-en-Y hepaticojejunostomy'}]","[{'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0006736', 'cui_str': 'Calculus'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0597984', 'cui_str': 'Biliary stricture'}, {'cui': 'C0008311', 'cui_str': 'Cholangitis'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",210.0,0.144708,"The primary efficacy endpoint of the trial will be the incidence of biliary complications (stone recurrence, biliary stricture, cholangitis) during the 3 years after surgery.","[{'ForeName': 'Jiang-Ming', 'Initials': 'JM', 'LastName': 'Chen', 'Affiliation': 'Department of Surgery, The First Affiliated Hospital of Anhui Medical University, Wanshui Road 120#, Gaoxin District, Hefei, 230022, Anhui, China.'}, {'ForeName': 'Xi-Yang', 'Initials': 'XY', 'LastName': 'Yan', 'Affiliation': 'Department of Surgery, The Second Affiliated Hospital of Anhui Medical University, Furong Road 678#, Shushan District, Hefei, 230022, Anhui, China.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Zhu', 'Affiliation': 'Department of Anesthesiology, The First Affiliated Hospital of USTC, Tianehu Road 1#, Administrative District, Hefei, 230022, Anhui, China.'}, {'ForeName': 'Zi-Xiang', 'Initials': 'ZX', 'LastName': 'Chen', 'Affiliation': 'Department of Surgery, The First Affiliated Hospital of Anhui Medical University, Wanshui Road 120#, Gaoxin District, Hefei, 230022, Anhui, China.'}, {'ForeName': 'Yi-Jun', 'Initials': 'YJ', 'LastName': 'Zhao', 'Affiliation': 'Department of Surgery, The First Affiliated Hospital of Anhui Medical University, Wanshui Road 120#, Gaoxin District, Hefei, 230022, Anhui, China.'}, {'ForeName': 'Kun', 'Initials': 'K', 'LastName': 'Xie', 'Affiliation': 'Department of Surgery, The First Affiliated Hospital of Anhui Medical University, Wanshui Road 120#, Gaoxin District, Hefei, 230022, Anhui, China.'}, {'ForeName': 'Fu-Bao', 'Initials': 'FB', 'LastName': 'Liu', 'Affiliation': 'Department of Surgery, The First Affiliated Hospital of Anhui Medical University, Wanshui Road 120#, Gaoxin District, Hefei, 230022, Anhui, China. liufubao88@163.com.'}, {'ForeName': 'Xiao-Ping', 'Initials': 'XP', 'LastName': 'Geng', 'Affiliation': 'Department of Surgery, The First Affiliated Hospital of Anhui Medical University, Wanshui Road 120#, Gaoxin District, Hefei, 230022, Anhui, China.'}]",Trials,['10.1186/s13063-020-04483-z'] 2218,32600480,A systematic review of ketamine for the treatment of depression among older adults.,"OBJECTIVE To review the currently available data on the use of ketamine in the treatment of depression among older adults from randomized controlled studies. DESIGN Randomized controlled trials. SETTING Variable. PARTICIPANTS 60 years and older with depression. INTERVENTION Ketamine. MEASUREMENTS Change in Montgomery-Asberg Depression Rating Scale (MADRS) scores. RESULTS Two studies met the inclusion criteria. The first study showed a significant reduction in depression symptoms with use of repeated subcutaneous ketamine administration among older adults with depression. The second study failed to achieve significance on its primary outcome measure but did show a decrease in MADRS scores with intranasal ketamine along with a higher response and remission rates in esketamine group compared with the placebo group. The adverse effects from ketamine generally lasted only a few hours and abated spontaneously. No cognitive adverse effects were noted in either trial from the use of ketamine. CONCLUSIONS The current evidence for use of ketamine among older adults with depression indicates some benefits with one positive and one negative trial. Although one of the trials did not achieve significance on the primary outcome measure, it still showed benefit of ketamine in reducing depressive symptoms. Ketamine was well tolerated in both studies with adverse effects being mild and transient.",2020,The second study failed to achieve significance on its primary outcome measure but did show a decrease in MADRS scores with intranasal ketamine along with a higher response and remission rates in esketamine group compared with the placebo group.,"['60 years and older with depression', 'older adults with depression', 'older adults']","['placebo', 'ketamine', 'Ketamine', 'intranasal ketamine']","['Change in Montgomery-Asberg Depression Rating Scale (MADRS) scores', 'cognitive adverse effects', 'MADRS scores', 'adverse effects', 'depression symptoms', 'response and remission rates', 'depressive symptoms']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0022614', 'cui_str': 'Ketamine'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C4706358', 'cui_str': 'MADRS (Montgomery-Asberg Depression Rating Scale) score'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}]",,0.165739,The second study failed to achieve significance on its primary outcome measure but did show a decrease in MADRS scores with intranasal ketamine along with a higher response and remission rates in esketamine group compared with the placebo group.,"[{'ForeName': 'Aarti', 'Initials': 'A', 'LastName': 'Gupta', 'Affiliation': 'Department of Psychiatry, Yale School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Romika', 'Initials': 'R', 'LastName': 'Dhar', 'Affiliation': 'Department of Medicine, West Virginia University School of Medicine, Morgantown, WV, USA.'}, {'ForeName': 'Palak', 'Initials': 'P', 'LastName': 'Patadia', 'Affiliation': 'Northeast Ohio Medical University (NEOMED), Rootstown, OH, USA.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Funaro', 'Affiliation': 'Harvey Cushing/John Hay Whitney Medical Library, Yale University, New Haven, CT, USA.'}, {'ForeName': 'Gargi', 'Initials': 'G', 'LastName': 'Bhattacharya', 'Affiliation': 'Purdue University, West Lafayette, IN, USA.'}, {'ForeName': 'Syeda A', 'Initials': 'SA', 'LastName': 'Farheen', 'Affiliation': 'Department of Psychiatry, Case Western Reserve University MetroHealth Program, Cleveland, OH, USA.'}, {'ForeName': 'Rajesh R', 'Initials': 'RR', 'LastName': 'Tampi', 'Affiliation': 'Department of Psychiatry, Yale School of Medicine, New Haven, CT, USA.'}]",International psychogeriatrics,['10.1017/S1041610220000903'] 2219,32600481,Interleukin-6 and total antioxidant capacity levels following N-acetylcysteine and a combination nutraceutical intervention in a randomised controlled trial for bipolar disorder.,"OBJECTIVE The aims of this study were to evaluate changes in inflammatory and oxidative stress levels following treatment with N-acetylcysteine (NAC) or mitochondrial-enhancing agents (CT), and to assess the how these changes may predict and/or moderate clinical outcomes primarily the Montgomery-Åsberg Depression Rating Scale (MADRS). METHODS This study involved secondary analysis of a placebo-controlled randomised trial (n=163). Serum samples were collected at baseline and week 16 of the clinical trial to determine changes in interleukin (IL)-6 and total antioxidant capacity (TAC) following adjunctive CT and/or NAC treatment, and to explore the predictability of the outcome or moderator effects of these markers. RESULTS In the NAC treated group, no difference was observed in serum IL-6 and TAC levels after 16 weeks of treatment with NAC or CT. However, results from a moderator analysis showed that in the CT group, lower IL-6 levels at baseline was a significant moderator of MADRS χ2 (df) = 4.90, p=0.027) and Clinical Global Impression-improvement (CGI-I, X2 (df)=6.28 p=0.012). In addition, IL-6 was a non-specific but significant predictor of functioning (based on the Social and Occupational Functioning Assessment Scale (SOFAS)), indicating that individuals with higher IL-6 levels at baseline had a greater improvement on SOFAS regardless of their treatment (p=0.023). CONCLUSION Participants with lower IL-6 levels at baseline had a better response to the adjunctive treatment with the mitochondrial-enhancing agents in terms of improvements in MADRS and CGI-I outcomes.",2020,"In the NAC treated group, no difference was observed in serum IL-6 and TAC levels after 16 weeks of treatment with NAC or CT.",['bipolar disorder'],"['N-acetylcysteine and a combination nutraceutical intervention', 'N-acetylcysteine (NAC) or mitochondrial-enhancing agents (CT', 'placebo']","['Clinical Global Impression-improvement (CGI-I, X2', 'SOFAS regardless', 'IL-6 levels', 'serum IL-6 and TAC levels', 'lower IL-6 levels', 'interleukin (IL)-6 and total antioxidant capacity (TAC', 'Interleukin-6 and total antioxidant capacity levels', 'inflammatory and oxidative stress levels', 'Montgomery-Åsberg Depression Rating Scale (MADRS', 'Social and Occupational Functioning Assessment Scale (SOFAS']","[{'cui': 'C0005586', 'cui_str': 'Bipolar disorder'}]","[{'cui': 'C0001047', 'cui_str': 'Acetylcysteine'}, {'cui': 'C1518478', 'cui_str': 'Nutriceuticals'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0026237', 'cui_str': 'Mitochondrion'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C2960593', 'cui_str': 'Montgomery-Åsberg depression rating scale'}, {'cui': 'C0521127', 'cui_str': 'Occupational'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales'}]",163.0,0.296478,"In the NAC treated group, no difference was observed in serum IL-6 and TAC levels after 16 weeks of treatment with NAC or CT.","[{'ForeName': 'C C', 'Initials': 'CC', 'LastName': 'Bortolasci', 'Affiliation': 'The Institute for Mental and Physical Health and Clinical Translation, Deakin University, Barwon Health, Geelong, Australia.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Voigt', 'Affiliation': 'University of Bremen, Bremen, Germany.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Turner', 'Affiliation': 'The Institute for Mental and Physical Health and Clinical Translation, Deakin University, Barwon Health, Geelong, Australia.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Mohebbi', 'Affiliation': 'Biostatistics Unit, Faculty of Health, Deakin University, Geelong, Australia.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Gray', 'Affiliation': 'The Institute for Mental and Physical Health and Clinical Translation, Deakin University, Barwon Health, Geelong, Australia.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Dodd', 'Affiliation': 'The Institute for Mental and Physical Health and Clinical Translation, Deakin University, Barwon Health, Geelong, Australia.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Walder', 'Affiliation': 'The Institute for Mental and Physical Health and Clinical Translation, Deakin University, Barwon Health, Geelong, Australia.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Berk', 'Affiliation': 'The Institute for Mental and Physical Health and Clinical Translation, Deakin University, Barwon Health, Geelong, Australia.'}, {'ForeName': 'S M', 'Initials': 'SM', 'LastName': 'Cotton', 'Affiliation': 'Orygen, The National Centre of Excellence in Youth Mental Health, Parkville, Australia.'}, {'ForeName': 'G S', 'Initials': 'GS', 'LastName': 'Malhi', 'Affiliation': 'NICM Health Research Institute, Westmead, Western Sydney University.'}, {'ForeName': 'C H', 'Initials': 'CH', 'LastName': 'Ng', 'Affiliation': 'Professorial Unit, The Melbourne Clinic, Department of Psychiatry, The University of Melbourne.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Dowling', 'Affiliation': 'Professorial Unit, The Melbourne Clinic, Department of Psychiatry, The University of Melbourne.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Sarris', 'Affiliation': 'Professorial Unit, The Melbourne Clinic, Department of Psychiatry, The University of Melbourne.'}, {'ForeName': 'O M', 'Initials': 'OM', 'LastName': 'Dean', 'Affiliation': 'The Institute for Mental and Physical Health and Clinical Translation, Deakin University, Barwon Health, Geelong, Australia.'}]",Acta neuropsychiatrica,['10.1017/neu.2020.25'] 2220,32600489,Volunteers' experiences of providing telephone-based breast-feeding peer support in the RUBY randomised controlled trial.,"OBJECTIVE The Ringing Up About Breastfeeding earlY (RUBY) randomised controlled trial (RCT) found that a telephone-based peer volunteer support intervention increased breast-feeding duration in a setting with high breast-feeding initiation. This sub-study of the RUBY RCT describes the motivation, preparation and experiences of volunteers who provided the peer support intervention. DESIGN An online survey was completed by 154 (67 %) volunteers after ceasing volunteering. SETTING Volunteers provided peer support to primiparous women (n 574) who birthed at one of three public hospitals in Melbourne, Australia, between February 2013 and December 2015. PARTICIPANTS Volunteers (n 230) had themselves breastfed for at least 6 months and received 4 h of training for the role. RESULTS The median number of mothers supported was two (range 1-11), and two-thirds of respondents supported at least one mother for 6 months. Volunteers were motivated by a strong desire to support new mothers to establish and continue breast-feeding. Most (93 %) considered the training session adequate. The majority (60 %) reported following the call schedule 'most of the time', but many commented that 'it depends on the mother'. Overall, 84 % of volunteers were satisfied with the role and reported that the experience was enjoyable (85 %) and worthwhile (90 %). Volunteers agreed that telephone support for breast-feeding was valued by women (88 %) and that the programme would be effective in helping women to breastfeed (93 %). CONCLUSIONS These findings are important for those developing similar peer support programmes in which recruiting volunteers and developing training requirements are an integral and recurrent part of volunteer management.",2020,found that a telephone-based peer volunteer support intervention increased breast-feeding duration in a setting with high breast-feeding initiation.,"['Volunteers provided peer support to primiparous women (n 574) who birthed at one of three public hospitals in Melbourne, Australia, between February 2013 and December 2015', 'Volunteers (n 230) had themselves breastfed for at least 6 months and received 4 h of training for the role']","['RUBY RCT', 'telephone-based breast-feeding peer support', 'telephone-based peer volunteer support intervention', 'Ringing Up']","['breast-feeding duration', 'median number of mothers']","[{'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0033150', 'cui_str': 'Para 1'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0020022', 'cui_str': 'Public Hospitals'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0035820', 'cui_str': 'Role'}]","[{'cui': 'C0521164', 'cui_str': 'Annular shape'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0026591', 'cui_str': 'Mother'}]",,0.031904,found that a telephone-based peer volunteer support intervention increased breast-feeding duration in a setting with high breast-feeding initiation.,"[{'ForeName': 'H A', 'Initials': 'HA', 'LastName': 'Grimes', 'Affiliation': 'Judith Lumley Centre, La Trobe University, Melbourne, Victoria3000, Australia.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Shafiei', 'Affiliation': 'Judith Lumley Centre, La Trobe University, Melbourne, Victoria3000, Australia.'}, {'ForeName': 'H L', 'Initials': 'HL', 'LastName': 'McLachlan', 'Affiliation': 'Judith Lumley Centre, La Trobe University, Melbourne, Victoria3000, Australia.'}, {'ForeName': 'D A', 'Initials': 'DA', 'LastName': 'Forster', 'Affiliation': 'Judith Lumley Centre, La Trobe University, Melbourne, Victoria3000, Australia.'}]",Public health nutrition,['10.1017/S136898002000124X'] 2221,32600499,When expanding training from working memory to emotional working memory: not only improving explicit emotion regulation but also implicit negative control for anxious individuals.,"BACKGROUND The effect of working memory training (WM-T) has been found to transfer to emotional wellbeing, despite some debate on whether an affective component in training is necessary to achieve specific emotion-related benefits. These novel cognitive trainings have not yet been tested in highly anxious individuals, who have deficits in implicit and explicit emotional regulation and should be the potential beneficiaries of these trainings. METHODS We designed two types of mobile phone-based training applications: (1) WMT and (2) an emotional working memory training (EWM-T) that comprised negative face distraction. Ninety-eight participants (33, WM-T; 35, EWM-T; 30, Control group) with high trait anxiety completed the 21-day intervention or placebo program and conducted pre- and post-test procedures, including questionnaires, emotional regulation and emotional Stroop tasks alongside electroencephalogram recording. Late positive potential (LPP) in emotion regulation task and P3 in the emotional Stroop task were adopted as neutral indicators for the explicit and implicit affective regulation/control processing. RESULTS Those who had received training (WM-T and EWM-T) showed enhanced explicit regulation (indexed by reduced LPP during reappraisal) compared with the control. Besides, individuals in EWM-T showed reduced behavioral attention bias and a decline of P3 in response to negative faces in an emotional Stroop task. The altered neural indicators were correlated with corresponding behavior indexes that contributed to the anxiety alleviation. CONCLUSIONS The general WM-T was effective in enhancing explicit emotional regulation, while training with emotional add-in further improved implicit emotional control. (E)WM-T shows potential as a beneficial intervention for the anxiety population.",2020,"The general WM-T was effective in enhancing explicit emotional regulation, while training with emotional add-in further improved implicit emotional control.",['Ninety-eight participants (33'],"['mobile phone-based training applications: (1) WMT and (2) an emotional working memory training (EWM-T) that comprised negative face distraction', 'working memory training (WM-T']","['behavioral attention bias', 'enhanced explicit regulation', 'questionnaires, emotional regulation and emotional Stroop tasks alongside electroencephalogram recording', 'explicit emotion regulation', 'implicit emotional control', 'Late positive potential (LPP) in emotion regulation task and P3 in the emotional Stroop task']","[{'cui': 'C4319627', 'cui_str': '98'}]","[{'cui': 'C1136360', 'cui_str': 'Car Phone'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0150189', 'cui_str': 'Distraction training'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0005346', 'cui_str': 'Biases'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C2718024', 'cui_str': 'Stroop Task'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C1446409', 'cui_str': 'Positive'}]",98.0,0.0335546,"The general WM-T was effective in enhancing explicit emotional regulation, while training with emotional add-in further improved implicit emotional control.","[{'ForeName': 'Dong-Ni', 'Initials': 'DN', 'LastName': 'Pan', 'Affiliation': 'Key Laboratory of Mental Health, Institute of Psychology, Chinese Academy of Sciences, Beijing100101, China.'}, {'ForeName': 'Delhii', 'Initials': 'D', 'LastName': 'Hoid', 'Affiliation': 'Key Laboratory of Mental Health, Institute of Psychology, Chinese Academy of Sciences, Beijing100101, China.'}, {'ForeName': 'Xiao-Bo', 'Initials': 'XB', 'LastName': 'Wang', 'Affiliation': 'Key Laboratory of Mental Health, Institute of Psychology, Chinese Academy of Sciences, Beijing100101, China.'}, {'ForeName': 'Zhuo', 'Initials': 'Z', 'LastName': 'Jia', 'Affiliation': 'Key Laboratory of Mental Health, Institute of Psychology, Chinese Academy of Sciences, Beijing100101, China.'}, {'ForeName': 'Xuebing', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Key Laboratory of Mental Health, Institute of Psychology, Chinese Academy of Sciences, Beijing100101, China.'}]",Psychological medicine,['10.1017/S0033291720002275'] 2222,32600626,Depressive symptoms as a moderator of college student response to computerized alcohol intervention.,"BACKGROUND Personalized normative alcohol feedback (PNF) is associated with decreased alcohol use among young adults. However, limited research has examined the influence of depressive symptoms on PNF efficacy. This study examined symptoms of depression as a moderator of college student response to a computerized PNF intervention for alcohol use. METHODS College students (N = 212, 59% female) who reported drinking in a typical week completed baseline and one-month assessments as part of a previously published intervention trial. We randomized participants to alcohol PNF (n = 153) or assessment only (n = 59). We used regression models to examine the interaction between PNF and symptoms of depression on alcohol outcomes at one-month follow-up. RESULTS One in four participants screened positive for clinically significant symptoms of depression. Depressive symptoms did not moderate intervention effects on drinking quantity. However, PNF was only associated with reduced frequency of heavy episodic drinking and lower probability of any alcohol-related consequence in the context of mild to moderate (not minimal) symptoms of depression. CONCLUSIONS PNF is more effective than assessment alone in reducing drinking quantity, regardless of symptoms of depression. However, it may only be more effective in decreasing frequency of heavy episodic drinking and the probability of alcohol-related consequences among those experiencing mild to moderate (as opposed to minimal) symptoms of depression. Alcohol intervention trials should assess symptoms of depression and consider them in data analysis.",2020,"However, PNF was only associated with reduced frequency of heavy episodic drinking and lower probability of any alcohol-related consequence in the context of mild to moderate (not minimal) symptoms of depression. ","['n\xa0=\xa0153) or assessment only (n\xa0=\xa059', 'College students (N\xa0=\xa0212, 59% female) who reported drinking in a typical week completed baseline and one-month assessments as part of a previously published intervention trial', 'young adults']","['Personalized normative alcohol feedback (PNF', 'Alcohol intervention', 'computerized PNF intervention', 'computerized alcohol intervention', 'PNF', 'alcohol PNF']","['drinking quantity', 'frequency of heavy episodic drinking', 'Depressive symptoms']","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C4082115', 'cui_str': 'One month'}, {'cui': 'C0034037', 'cui_str': 'Publishing'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C1265611', 'cui_str': 'Quantity'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0439539', 'cui_str': 'Heavy (weight)'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]",,0.025499,"However, PNF was only associated with reduced frequency of heavy episodic drinking and lower probability of any alcohol-related consequence in the context of mild to moderate (not minimal) symptoms of depression. ","[{'ForeName': 'Mary Beth', 'Initials': 'MB', 'LastName': 'Miller', 'Affiliation': 'Department of Psychiatry, University of Missouri School of Medicine, 1 Hospital Dr DC067.00, Columbia, MO 65212, USA. Electronic address: millmary@health.missouri.edu.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Hall', 'Affiliation': 'Department of Psychiatry, University of Missouri School of Medicine, 1 Hospital Dr DC067.00, Columbia, MO 65212, USA.'}, {'ForeName': 'Angelo M', 'Initials': 'AM', 'LastName': 'DiBello', 'Affiliation': 'Department of Psychology, City University of New York, Brooklyn College, 2900 Bedford Ave, Brooklyn, NY 11210, USA.'}, {'ForeName': 'Chan Jeong', 'Initials': 'CJ', 'LastName': 'Park', 'Affiliation': 'Department of Psychiatry, University of Missouri School of Medicine, 1 Hospital Dr DC067.00, Columbia, MO 65212, USA.'}, {'ForeName': 'Lindsey', 'Initials': 'L', 'LastName': 'Freeman', 'Affiliation': 'Department of Psychiatry, University of Missouri School of Medicine, 1 Hospital Dr DC067.00, Columbia, MO 65212, USA.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Meier', 'Affiliation': 'Department of Psychology, University of Wisconsin - Stevens Point, Science Building, Stevens Point, WI 54481, USA.'}, {'ForeName': 'Eleanor L S', 'Initials': 'ELS', 'LastName': 'Leavens', 'Affiliation': 'Department of Psychology, Oklahoma State University, 116 North Murray, Stillwater, OK 74078, USA.'}, {'ForeName': 'Thad R', 'Initials': 'TR', 'LastName': 'Leffingwell', 'Affiliation': 'Department of Psychology, Oklahoma State University, 116 North Murray, Stillwater, OK 74078, USA.'}]",Journal of substance abuse treatment,['10.1016/j.jsat.2020.108038'] 2223,32600919,Lapatinib plus Capecitabine versus Trastuzumab plus Capecitabine in the Treatment of Human Epidermal Growth Factor Receptor 2-positive Metastatic Breast Cancer with Central Nervous System Metastases for Patients Currently or Previously Treated with Trastuzumab (LANTERN): a Phase II Randomised Trial.,"AIMS Brain (central nervous system; CNS) metastases occur in 30-50% of patients with human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer (MBC). A substantive evidence base for treatment is lacking, but activity with lapatinib plus capecitabine (lap-cap) has been reported. We compared lap-cap with trastuzumab plus capecitabine (tras-cap) in patients with HER2-positive MBC with CNS metastases previously treated with trastuzumab. MATERIALS AND METHODS This open-label randomised phase II screening trial aimed to randomise 130 participants over 2 years to receive lap-cap or tras-cap. Eligible patients had HER2-positive MBC with newly diagnosed or recently progressed CNS metastases; previous, or current, treatment included: trastuzumab, a taxane or anthracycline and recent completion of local cranial therapy. The primary end point was time to progression of CNS metastases within the 24-week trial period. Secondary objectives included CNS response rate, progression-free survival, steroid use for CNS symptoms and feasibility of recruitment to a large phase III trial. RESULTS Between September 2011 and October 2013, 30 participants were randomised, 16 to lap-cap and 14 to tras-cap. Recruitment to a large phase III trial was determined not to be feasible. At 24 weeks, CNS disease progression was 41.8% (95% confidence interval 16.1-67.5%) in lap-cap and 41.2% (95% confidence interval 12.8-69.6%) in tras-cap arms; progression-free survival was 44.4% (95% confidence interval 18.1-70.8%) in lap-cap and 50.0% (95% confidence interval 20.9-79.1%) in tras-cap arms. CONCLUSION Poor recruitment confirmed that a larger phase III trial would not be feasible and prohibited a preliminary evaluation of the superiority of lap-cap over tras-cap. Descriptive statistics are presented to inform the limited evidence base and future study design.",2020,"At 24 weeks, CNS disease progression was 41.8% (95% confidence interval 16.1-67.5%) in lap-cap and 41.2% (95% confidence interval 12.8-69.6%) in tras-cap arms; progression-free survival was 44.4% (95% confidence interval 18.1-70.8%) in lap-cap and 50.0% (95% confidence interval 20.9-79.1%) in tras-cap arms. ","['Between September 2011 and October 2013', '30 participants were randomised, 16 to lap-cap and 14 to tras-cap', '130 participants over 2 years to receive', 'Human Epidermal Growth Factor Receptor 2-positive Metastatic Breast Cancer with Central Nervous System Metastases for Patients', 'patients with HER2-positive MBC with CNS metastases previously treated with', '30-50% of patients with human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer (MBC', 'Eligible patients had HER2-positive MBC with newly diagnosed or recently progressed CNS metastases; previous, or current, treatment included']","['trastuzumab', 'lap-cap with trastuzumab plus capecitabine (tras-cap', 'Trastuzumab', 'trastuzumab, a taxane or anthracycline', 'lapatinib plus capecitabine', 'Lapatinib plus Capecitabine versus Trastuzumab plus Capecitabine', 'lap-cap or tras-cap']","['CNS response rate, progression-free survival, steroid use for CNS symptoms and feasibility of recruitment to a large phase III trial', 'CNS disease progression', 'progression-free survival', 'time to progression of CNS metastases']","[{'cui': 'C1506770', 'cui_str': 'lapatinib'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0242957', 'cui_str': 'Genes, erbb2'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0278488', 'cui_str': 'Breast cancer stage IV'}, {'cui': 'C0279130', 'cui_str': 'CNS metastases'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C1506770', 'cui_str': 'lapatinib'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C0215136', 'cui_str': 'taxane'}, {'cui': 'C0003234', 'cui_str': 'Anthracycline'}]","[{'cui': 'C0028654', 'cui_str': 'Clinical nurse specialist'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0038317', 'cui_str': 'Steroid'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0422879', 'cui_str': 'CNS symptom'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0282461', 'cui_str': 'Clinical Trials, Phase 3 as Topic'}, {'cui': 'C0007682', 'cui_str': 'Disorder of the central nervous system'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0279130', 'cui_str': 'CNS metastases'}]",30.0,0.378866,"At 24 weeks, CNS disease progression was 41.8% (95% confidence interval 16.1-67.5%) in lap-cap and 41.2% (95% confidence interval 12.8-69.6%) in tras-cap arms; progression-free survival was 44.4% (95% confidence interval 18.1-70.8%) in lap-cap and 50.0% (95% confidence interval 20.9-79.1%) in tras-cap arms. ","[{'ForeName': 'J F', 'Initials': 'JF', 'LastName': 'Seligmann', 'Affiliation': 'Clinical Trials Research Unit, University of Leeds, Leeds, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Wright-Hughes', 'Affiliation': 'Clinical Trials Research Unit, University of Leeds, Leeds, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Pottinger', 'Affiliation': 'Clinical Trials Research Unit, University of Leeds, Leeds, UK.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Velikova', 'Affiliation': ""St James's Institute of Oncology, St James University Hospital, Leeds, UK.""}, {'ForeName': 'J B', 'Initials': 'JB', 'LastName': 'Oughton', 'Affiliation': 'Clinical Trials Research Unit, University of Leeds, Leeds, UK.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Murden', 'Affiliation': 'Clinical Trials Research Unit, University of Leeds, Leeds, UK.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Rizwanullah', 'Affiliation': 'Department of Clinical Oncology, The Beatson West of Scotland Cancer Centre, Glasgow, UK.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Price', 'Affiliation': 'Department of Medical Oncology, University Hospitals, Bristol, UK.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Passant', 'Affiliation': 'Department of Medical Oncology, Velindre Hospital, Cardiff, UK.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Heudtlass', 'Affiliation': 'Clinical Trials Research Unit, University of Leeds, Leeds, UK.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Marshall', 'Affiliation': 'Clinical Trials Research Unit, University of Leeds, Leeds, UK.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Johnston', 'Affiliation': 'Department of Medical Oncology, The Royal Marsden NHS Foundation Trust, London, UK.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Dodwell', 'Affiliation': ""St James's Institute of Oncology, St James University Hospital, Leeds, UK; Nuffield Department of Population Health, Oxford University, Oxford, UK. Electronic address: david.dodwell@nhs.net.""}]",Clinical oncology (Royal College of Radiologists (Great Britain)),['10.1016/j.clon.2020.06.003'] 2224,32600942,Live birth after a freeze-only strategy versus fresh embryo transfer in three randomized trials considering progesterone concentration.,"RESEARCH QUESTION Is there a difference in live birth rate between a freeze-only strategy and fresh embryo transfer, and what is the effect of varying progesterone concentrations on the day of human chorionic gonadotrophin (HCG) administration? DESIGN A secondary analysis of data from three randomized trials comparing the live birth rate after elective frozen versus fresh embryo transfer, which respectively enrolled 1508 women with polycystic ovary syndrome, 2157 ovulatory women who underwent cleavage-stage embryo transfer and 1650 ovulatory women who underwent single blastocyst transfer. Women were randomly assigned to the frozen or fresh embryo transfer group in the original trials. The primary outcome was live birth rate after the initial embryo transfer. RESULTS The live birth rate after a freeze-only strategy was consistently higher than fresh embryo transfer at any progesterone concentration on the day of HCG administration. Nonetheless, the between-group difference in live birth rate after frozen versus fresh embryo transfer was greater in women with progesterone concentrations ≥1.14 ng/ml (52.7% versus 37.3%, odds ratio (OR) 1.88, 95% confidence interval (CI) 1.55-2.27, P = 7.89  ×  10 -11 ) than in women with progesterone concentrations <1.14 ng/ml (53.3% versus 48.1%, OR 1.23, 95% CI 1.08-1.41, P = 0.002). In women with progesterone concentration ≥1.14 ng/ml, frozen embryo transfer also resulted in higher rates of conception and clinical pregnancy than fresh embryo transfer. CONCLUSION In women with normal or high ovarian response, a freeze-only strategy resulted in a higher live birth rate than fresh embryo transfer, irrespective of progesterone concentration. Moreover, women with progesterone concentration ≥1.14 ng/ml may benefit more from a freeze-only strategy.",2020,"In women with progesterone concentration ≥1.14 ng/ml, frozen embryo transfer also resulted in higher rates of conception and clinical pregnancy than fresh embryo transfer. ","['women with progesterone concentration ≥1.14', '1508 women with polycystic ovary syndrome, 2157 ovulatory women who underwent cleavage-stage embryo transfer and 1650 ovulatory women who underwent single blastocyst transfer', 'women with normal or high ovarian response']","['frozen or fresh embryo transfer', 'freeze-only strategy versus fresh embryo transfer', 'elective frozen versus fresh embryo transfer']","['rates of conception and clinical pregnancy', 'live birth rate after the initial embryo transfer', 'live birth rate']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0033308', 'cui_str': 'Progesterone'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0032460', 'cui_str': 'Polycystic ovary syndrome'}, {'cui': 'C0429470', 'cui_str': 'Ovulatory'}, {'cui': 'C0010813', 'cui_str': 'Cytokinesis'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0013938', 'cui_str': 'Embryo transfer'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0936221', 'cui_str': 'Blastocyst Transfer'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0205250', 'cui_str': 'High'}]","[{'cui': 'C0016701', 'cui_str': 'Freezing'}, {'cui': 'C0440732', 'cui_str': 'Fresh embryo'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}]","[{'cui': 'C0009637', 'cui_str': 'Conception'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0481667', 'cui_str': 'Live birth'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0013938', 'cui_str': 'Embryo transfer'}]",2157.0,0.295536,"In women with progesterone concentration ≥1.14 ng/ml, frozen embryo transfer also resulted in higher rates of conception and clinical pregnancy than fresh embryo transfer. ","[{'ForeName': 'Yunhai', 'Initials': 'Y', 'LastName': 'Yu', 'Affiliation': 'Department of Obstetrics and Gynecology, Qilu Hospital, Cheeloo College of Medicine, Shandong University, Jinan 250001, China; Department of Obstetrics and Gynecology, Second Hospital, Cheeloo College of Medicine, Shandong University, Jinan 250000, China.'}, {'ForeName': 'Shigang', 'Initials': 'S', 'LastName': 'Zhao', 'Affiliation': 'Center for Reproductive Medicine, Cheeloo College of Medicine, Shandong University, Jinan 250001, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Obstetrics and Gynecology, Affiliated Hospital of Qingdao University, Qingdao 266003, China.'}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Niu', 'Affiliation': 'Center for Reproductive Medicine, Cheeloo College of Medicine, Shandong University, Jinan 250001, China.'}, {'ForeName': 'Daimin', 'Initials': 'D', 'LastName': 'Wei', 'Affiliation': 'School of Medicine, Cheeloo College of Medicine, Shandong University, Jinan 250012, China. Electronic address: sdweidaimin@163.com.'}, {'ForeName': 'Shiqian', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': 'Department of Obstetrics and Gynecology, Qilu Hospital, Cheeloo College of Medicine, Shandong University, Jinan 250001, China. Electronic address: r370112@126.com.'}, {'ForeName': 'Zi-Jiang', 'Initials': 'ZJ', 'LastName': 'Chen', 'Affiliation': 'Center for Reproductive Medicine, Cheeloo College of Medicine, Shandong University, Jinan 250001, China; School of Medicine, Cheeloo College of Medicine, Shandong University, Jinan 250012, China.'}, {'ForeName': 'Heping', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Department of Biostatistics, Yale University School of Public Health, New Haven CT 06520, USA.'}, {'ForeName': 'Richard S', 'Initials': 'RS', 'LastName': 'Legro', 'Affiliation': 'Department of Obstetrics and Gynecology, Penn State College of Medicine, Hershey PA 17033, USA.'}]",Reproductive biomedicine online,['10.1016/j.rbmo.2020.04.021'] 2225,32600949,A nomogram for prediction of distant metastasis in children with wilms tumor: A study based on SEER database.,"INTRODUCTION Accurate diagnosis of distant metastasis especially uncommon site of metastasis (UCM) in patients with Wilms tumor (WTs) is a demanding prerequisite for administration of appropriate therapy and achieving better survival outcome. OBJECTIVE To develop and validate a nomogram to predict probability of distant metastasis, and identify population demanded for rigorous imaging evaluations in children with WTs. MATERIAL AND METHODS Data of patients diagnosed with unilateral WTs and aged under 18 years old, were extracted from the Surveillance, Epidemiology, and End Results (SEER) database. The included patients were randomly allocated to the training and the validation cohort. Logistic regression analyses were performed to identify the independent risk factors and develop a predicting model of distant metastasis in WTs. The model-based nomogram was created and internally validated. Cut-off value of nomogram points was derived by using the receiver operating characteristics (ROC) curve analysis. Performance of the nomogram was evaluated in terms of discrimination, calibration and clinical usefulness. RESULTS A total 717 WTs patients were included in the study. Age at diagnosis (OR 1.173, 95%CI: 1.079-1.279), LND (OR 8.260, 95%CI: 2.837-24.814) and tumor size (OR 2.141, 95%CI: 1.378-3.329) were identified as the independent risk factors of distant metastasis in WTs. These three factors were incorporated to develop a model and a nomogram. The nomogram presented with good discriminative ability in the training cohort (C-statistics, 0.703) and validation cohort (C-statistics, 0.764), respectively. The calibration curves demonstrated adequate agreement between predicted probability and observed probability of distant metastasis. The nomogram also revealed its clinical usefulness by application of decision curve analysis (DCA). Cut-off value of nomogram points was 58 and its corresponding probability of distant metastasis was 0.22. The value was applied in risk stratification dividing the general cohort into high-risk and low-risk group. DISCUSSION Our study for the first time developed and validated a model and a visualized nomogram for individualized prediction of distant metastasis in WTs. C-statistics, calibration curves and DCA demonstrated good performance and clinical usefulness of the nomogram. Patients stratified as high-risk group were demanded for rigorous imaging evaluations to accurately identify UCM. CONCLUSION The nomogram, developed by incorporation of three independent risk factors, which are age at diagnosis, LND and tumor size, is used to facilitate individualized prediction of distant metastasis in WTs. Rigorous imaging evaluations are recommended for patients in high-risk group to identify UCM.",2020,"The nomogram presented with good discriminative ability in the training cohort (C-statistics, 0.703) and validation cohort (C-statistics, 0.764), respectively.","['children with wilms tumor', 'children with WTs', 'A total 717 WTs patients were included in the study', 'Data of patients diagnosed with unilateral WTs and aged under 18 years old, were extracted from the Surveillance, Epidemiology, and End Results (SEER) database', 'patients in high-risk group to identify UCM', 'patients with Wilms tumor (WTs']",[],['tumor size '],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0027708', 'cui_str': 'Nephroblastoma'}, {'cui': 'C1839736', 'cui_str': 'Wilson-Turner X-linked mental retardation syndrome'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0220920', 'cui_str': 'surveillance'}, {'cui': 'C0014507', 'cui_str': 'Epidemiology'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0993637', 'cui_str': 'Data Base'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0522498', 'cui_str': 'Rare'}, {'cui': 'C2945843', 'cui_str': 'Site of'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}]",[],"[{'cui': 'C0475440', 'cui_str': 'Tumor size'}]",717.0,0.03782,"The nomogram presented with good discriminative ability in the training cohort (C-statistics, 0.703) and validation cohort (C-statistics, 0.764), respectively.","[{'ForeName': 'Yangyue', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': ""Department of Pediatric Urology, Beijing Children's Hospital, Capital Medical University, National Center for Children's Health, Beijing, 100045, China.""}, {'ForeName': 'Weiping', 'Initials': 'W', 'LastName': 'Zhang', 'Affiliation': ""Department of Pediatric Urology, Beijing Children's Hospital, Capital Medical University, National Center for Children's Health, Beijing, 100045, China.""}, {'ForeName': 'Hongcheng', 'Initials': 'H', 'LastName': 'Song', 'Affiliation': ""Department of Pediatric Urology, Beijing Children's Hospital, Capital Medical University, National Center for Children's Health, Beijing, 100045, China.""}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Sun', 'Affiliation': ""Department of Pediatric Urology, Beijing Children's Hospital, Capital Medical University, National Center for Children's Health, Beijing, 100045, China. Electronic address: drsunningbch@sina.com.""}]",Journal of pediatric urology,['10.1016/j.jpurol.2020.05.158'] 2226,32600994,Impact of donor-recipient age on cardiac transplant survival. Subanalysis of the Spanish Heart Transplant Registry.,"INTRODUCTION AND OBJECTIVES The age of heart transplant recipients and donors is progressively increasing. It is likely that not all donor-recipient age combinations have the same impact on mortality. The objective of this work was to compare survival in transplant recipients according to donor-recipient age combinations. METHODS We performed a retrospective analysis of transplants performed between 1 January 1993 and 31 December 2017 in the Spanish Heart Transplant Registry. Pediatric transplants, retransplants and combined transplants were excluded (6505 transplants included). Four groups were considered: a) donor <50 years for recipient <65 years; b) donor <50 years for recipient ≥ 65 years; c) donor ≥ 50 years for recipient ≥ 65 years, and d) donor ≥ 50 years for recipient <65 years. RESULTS The most frequent group was young donor for young recipient (73%). There were differences in the median survival between the groups (P <.001): a) younger-younger: 12.1 years, 95%CI, 11.5-12.6; b) younger-older: 9.1 years, 95%CI, 8.0-10.5; c) older-older: 7.5 years, 95%CI, 2.8-11.0; d) older-younger: 10.5 years, 95%CI, 9.6-12.1. On multivariate analysis, independent predictors of mortality were the age of the donor and the recipient (0.008 and 0.001, respectively). The worst combinations were older-older vs younger-younger (HR, 1.57; 95%CI, 1.22-2.01; P <.001) and younger-older vs younger-younger (HR, 1.33; 95%CI, 1.12-1.58; P=.001). CONCLUSIONS Age (of the donor and recipient) is a relevant prognostic factor in heart transplant. The donor-recipient age combination has prognostic implications that should be identified when accepting an organ for transplant.",2020,"There were differences in the median survival between the groups (P <.001): a) younger-younger: 12.1 years, 95%CI, 11.5-12.6; b) younger-older: 9.1 years, 95%CI, 8.0-10.5; c) older-older: 7.5 years, 95%CI, 2.8-11.0; d) older-younger: 10.5 years, 95%CI, 9.6-12.1.","['transplants performed between 1 January 1993 and 31 December 2017 in the Spanish Heart Transplant Registry', 'younger-younger: 12.1 years, 95%CI, 11.5-12.6; b) younger-older: 9.1 years, 95%CI, 8.0-10.5; c) older-older: 7.5 years, 95%CI, 2.8-11.0; d) older-younger: 10.5 years, 95%CI, 9.6-12.1', 'transplant recipients according to donor-recipient age combinations', 'Pediatric transplants, retransplants and combined transplants were excluded (6505 transplants included', ' donor ≥ 50 years for recipient <65 years', 'Four groups were considered: a) donor <50 years for recipient <65 years; b) donor <50 years for recipient ≥ 65 years; c) donor ≥ 50 years for recipient']",[],"['cardiac transplant survival', 'median survival', 'survival']","[{'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0037750', 'cui_str': 'Spanish language'}, {'cui': 'C0018823', 'cui_str': 'Transplantation of heart'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517534', 'cui_str': '11.5'}, {'cui': 'C4517545', 'cui_str': '12.6'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C4517521', 'cui_str': '10.5'}, {'cui': 'C0001795', 'cui_str': 'Oldest Old'}, {'cui': 'C4517859', 'cui_str': '7.5'}, {'cui': 'C0376387', 'cui_str': 'Recipient, Transplant'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]",[],"[{'cui': 'C0018823', 'cui_str': 'Transplantation of heart'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",6505.0,0.0771554,"There were differences in the median survival between the groups (P <.001): a) younger-younger: 12.1 years, 95%CI, 11.5-12.6; b) younger-older: 9.1 years, 95%CI, 8.0-10.5; c) older-older: 7.5 years, 95%CI, 2.8-11.0; d) older-younger: 10.5 years, 95%CI, 9.6-12.1.","[{'ForeName': 'Raquel', 'Initials': 'R', 'LastName': 'López-Vilella', 'Affiliation': 'Unidad de Insuficiencia Cardiaca y Trasplante, Servicio de Cardiología, Hospital Universitario y Politécnico La Fe, Valencia, Spain. Electronic address: lopez_raqvil@gva.es.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'González-Vílchez', 'Affiliation': 'Servicio de Cardiología, Hospital Universitario Marqués de Valdecilla, Santander, Cantabria, Spain.'}, {'ForeName': 'María G', 'Initials': 'MG', 'LastName': 'Crespo-Leiro', 'Affiliation': 'Servicio de Cardiología, Complexo Hospitalario Universitario A Coruña (CHUAC), A Coruña, Spain; Centro de Investigación Biomédica en Red Enfermedades Cardiovaculares, CIBERCV, A Coruña, Spain; Instituto de Investigación Biomédico A Coruña (INIBIC), A Coruña, Spain; Universidade da Coruña (UDC), A Coruña, Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Segovia-Cubero', 'Affiliation': 'Servicio de Cardiología, Hospital Universitario Puerta de Hierro de Majadahonda, Majadahonda, Madrid, Spain.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Cobo', 'Affiliation': 'Servicio de Cardiología, Hospital Universitario Marqués de Valdecilla, Santander, Cantabria, Spain.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Delgado-Jiménez', 'Affiliation': 'Servicio de Cardiología, Hospital Universitario 12 de Octubre, Madrid, Spain; Facultad de Medicina, Universidad Complutense de Madrid, Madrid, Spain; Centro de Investigación Biomédica en Red Enfermedades Cardiovaculares, CIBERCV, Madrid, Spain.'}, {'ForeName': 'José María', 'Initials': 'JM', 'LastName': 'Arizón Del Prado', 'Affiliation': 'Servicio de Cardiología, Hospital Universitario Reina Sofía, Córdoba, Spain.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Martínez-Sellés', 'Affiliation': 'Facultad de Medicina, Universidad Complutense de Madrid, Madrid, Spain; Centro de Investigación Biomédica en Red Enfermedades Cardiovaculares, CIBERCV, Madrid, Spain; Servicio de Cardiología, Hospital Universitario Gregorio Marañón, Madrid, Spain; Universidad Europea de Madrid, Madrid, Spain.'}, {'ForeName': 'José Manuel', 'Initials': 'JM', 'LastName': 'Sobrino Márquez', 'Affiliation': 'Servicio de Cardiología, Hospital Universitario Virgen del Rocío, Sevilla, Spain.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Mirabet-Pérez', 'Affiliation': 'Servicio de Cardiología, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'González-Costello', 'Affiliation': ""Servicio de Cardiología, Hospital Universitari de Bellvitge, L'Hospitalet de Llobregat, Barcelona, Spain.""}, {'ForeName': 'Félix', 'Initials': 'F', 'LastName': 'Pérez-Villa', 'Affiliation': 'Servicio de Cardiología, Hospital Clínic y Provincial de Barcelona, Barcelona, Spain.'}, {'ForeName': 'José Luis', 'Initials': 'JL', 'LastName': 'Lambert-Rodríguez', 'Affiliation': 'Servicio de Cardiología, Hospital Universitario Central de Asturias, Oviedo, Asturias, Spain.'}, {'ForeName': 'Gregorio', 'Initials': 'G', 'LastName': 'Rábago-Aracil', 'Affiliation': 'Servicio de Cardiología, Clínica Universitaria de Navarra, Pamplona, Navarra, Spain.'}, {'ForeName': 'María Teresa', 'Initials': 'MT', 'LastName': 'Blasco-Peiró', 'Affiliation': 'Servicio de Cardiología, Hospital Universitario Miguel Servet, Zaragoza, Spain.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'de la Fuente-Galán', 'Affiliation': 'Servicio de Cardiología, Hospital Clínico Universitario de Valladolid, Valladolid, Spain.'}, {'ForeName': 'Iris', 'Initials': 'I', 'LastName': 'Garrido-Bravo', 'Affiliation': 'Servicio de Cardiología, Hospital Virgen de la Arrixaca, El Palmar, Murcia, Spain.'}, {'ForeName': 'Déborah', 'Initials': 'D', 'LastName': 'Otero', 'Affiliation': 'Instituto de Investigación Biomédico A Coruña (INIBIC), A Coruña, Spain; Centro de Investigación Biomédica en Red Enfermedades Cardiovaculares, CIBERCV, A Coruña, Spain; Universidade da Coruña (UDC), A Coruña, Spain; Instituto Universitario de Ciencias de la Salud, A Coruña, Spain.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Almenar-Bonet', 'Affiliation': 'Unidad de Insuficiencia Cardiaca y Trasplante, Servicio de Cardiología, Hospital Universitario y Politécnico La Fe, Valencia, Spain; Centro de Investigación Biomédica en Red Enfermedades Cardiovaculares, CIBERCV, Madrid, Spain; Facultad de Medicina, Universitat de València, Valencia, Spain.'}]",Revista espanola de cardiologia (English ed.),['10.1016/j.rec.2020.02.016'] 2227,32601011,The effect of Yakson and Gentle Human Touch methods on pain and physiological parameters in preterm infants during heel lancing.,"BACKGROUND Various non-pharmacologic methods are used to alleviate pain in preterm infants who spend their first days in neonatal intensive care units (NICU) because they are exposed to numerous painful interventions. OBJECTIVE To determine the effects of Yakson and Gentle Human Touch (GHT) methods on pain and physiologic parameters during heel lancing procedures in preterm infants. DESIGN AND METHODS This was a randomised controlled trial. The study was conducted in a NICU between June 2018 and June 2019. A total of 90 preterm infants were divided into three groups: 30 infants in the Yakson group, 30 infants in the GHT group, and 30 infants in the control group. All preterm infants were randomly divided into groups. Pain responses were evaluated using the Neonatal Infant Pain Scale. RESULTS It was found that pain scores and heart rates were significantly lower during and after heel lancing in preterm infants in the Yakson and GHT groups than in the control group, the difference was statistically significant (p < .001). PRACTICAL IMPLICATIONS Yakson and GHT applied to preterm infants during heel lancing has positive effects on pain and physiologic parameters.",2020,"It was found that pain scores and heart rates were significantly lower during and after heel lancing in preterm infants in the Yakson and GHT groups than in the control group, the difference was statistically significant (p < .001). ","['NICU between June 2018 and June 2019', 'All preterm infants', '90 preterm infants were divided into three groups: 30 infants in the Yakson group, 30 infants in the GHT group, and 30 infants in the control group', 'preterm infants during heel lancing', 'preterm infants', 'preterm infants who spend their first days in neonatal intensive care units (NICU']","['Yakson and Gentle Human Touch (GHT) methods', 'Yakson and Gentle Human Touch methods']","['Neonatal Infant Pain Scale', 'pain scores and heart rates', 'pain and physiological parameters', 'pain and physiologic parameters', 'Pain responses']","[{'cui': 'C0021709', 'cui_str': 'Neonatal intensive care unit'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0152054', 'cui_str': 'Touch'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0018870', 'cui_str': 'Heel structure'}]","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0152054', 'cui_str': 'Touch'}, {'cui': 'C0025663', 'cui_str': 'Method'}]","[{'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C1504479', 'cui_str': 'Pain scale'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0424543', 'cui_str': 'Response to pain'}]",90.0,0.0465262,"It was found that pain scores and heart rates were significantly lower during and after heel lancing in preterm infants in the Yakson and GHT groups than in the control group, the difference was statistically significant (p < .001). ","[{'ForeName': 'Şadiye', 'Initials': 'Ş', 'LastName': 'Dur', 'Affiliation': 'Nursing Department, Faculty of Health Sciences, Bahçeşehir University, Istanbul, Turkey.'}, {'ForeName': 'Seda', 'Initials': 'S', 'LastName': 'Caglar', 'Affiliation': 'Pediatric Nursing Department, Florence Nightingale Faculty of Nursing, Istanbul University-Cerrahpaşa, Istanbul, Turkey. Electronic address: sedac@istanbul.edu.tr.'}, {'ForeName': 'Nagehan', 'Initials': 'N', 'LastName': 'Ustabaş', 'Affiliation': 'Health Sciences University Bursa Higher Specialization Training and Research Hospital, Neonatology Department, Bursa, Turkey.'}, {'ForeName': 'Pelin', 'Initials': 'P', 'LastName': 'Doğan', 'Affiliation': 'Health Sciences University Bursa Higher Specialization Training and Research Hospital, Neonatology Department, Bursa, Turkey.'}, {'ForeName': 'İpek Güney', 'Initials': 'İG', 'LastName': 'Vural', 'Affiliation': 'Health Sciences University Bursa Higher Specialization Training and Research Hospital, Neonatology Department, Bursa, Turkey.'}]",Intensive & critical care nursing,['10.1016/j.iccn.2020.102886'] 2228,32601033,"A propensity score weighted comparison of Vedolizumab, Adalimumab, and Golimumab in patients with ulcerative colitis.","BACKGROUND No real-life study on the comparative effectiveness of Vedolizumab (VDZ), Adalimumab (ADA), and Golimumab (GOL) in ulcerative colitis (UC) is currently available. AIMS To compare the effectiveness of the three biologics in consecutive patients with UC. METHODS A three-arms propensity score-adjusted analysis was performed using the Inverse Probability of Treatment Weighting method. RESULTS 463 treatments (VDZ: n = 187; ADA: n = 168; GOL: n = 108) were included (median follow-up: 47.6 weeks). At 12 weeks (n = 463), a steroid-free remission was reported in 24.1% patients in the VDZ group, in 33.3% patients in the ADA group, and in 30.6% patients in the GOL group (p = n.s. for all comparisons). At 52 weeks (n = 377), a steroid-free remission was reported in 51.5% patients in the VDZ group, in 31.2% patients in the ADA group, and in 29.4% patients in the GOL group (p = 0.002 for VDZ vs. ADA, p = 0.001 for VDZ vs. GOL, p = n.s. for ADA vs. GOL). Cox survival analysis demonstrated that patients treated with VDZ had reduced probability of treatment discontinuation compared to those treated with ADA (HR: 0.42, 95% CI 0.28-0.64, p < 0.001) and GOL (HR: 0.30, 95% CI 0.19-0.46, p < 0.001), while patients treated with ADA had reduced risk of treatment discontinuation compared to those treated with GOL (HR: 0.71, 95% CI 0.50-1.00, p = 0.048). CONCLUSIONS VDZ was superior to ADA and GOL at 52 weeks and as treatment persistence, while ADA showed a superior treatment persistence compared to GOL.",2020,"At 12 weeks (n = 463), a steroid-free remission was reported in 24.1% patients in the VDZ group, in 33.3% patients in the ADA group, and in 30.6% patients in the GOL group (p = n.s. for all comparisons).","['ulcerative colitis (UC', '463 treatments (VDZ: n\u202f=\u202f187; ADA: n\u202f=\u202f168', 'patients with ulcerative colitis', 'consecutive patients with UC']","['VDZ', 'ADA', 'Vedolizumab (VDZ), Adalimumab (ADA), and Golimumab (GOL', 'Vedolizumab, Adalimumab, and Golimumab']","['probability of treatment discontinuation', 'steroid-free remission', 'risk of treatment discontinuation', 'Cox survival analysis']","[{'cui': 'C0009324', 'cui_str': 'Ulcerative colitis'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C2742797', 'cui_str': 'vedolizumab'}, {'cui': 'C4517618', 'cui_str': '187'}, {'cui': 'C0001457', 'cui_str': 'Adenosine deaminase'}, {'cui': 'C4319556', 'cui_str': '168'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C2742797', 'cui_str': 'vedolizumab'}, {'cui': 'C0001457', 'cui_str': 'Adenosine deaminase'}, {'cui': 'C1122087', 'cui_str': 'adalimumab'}, {'cui': 'C2353893', 'cui_str': 'golimumab'}]","[{'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0038317', 'cui_str': 'Steroid'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0033551', 'cui_str': 'Prostaglandin synthase'}, {'cui': 'C0038953', 'cui_str': 'Analysis, Survival'}]",108.0,0.0991138,"At 12 weeks (n = 463), a steroid-free remission was reported in 24.1% patients in the VDZ group, in 33.3% patients in the ADA group, and in 30.6% patients in the GOL group (p = n.s. for all comparisons).","[{'ForeName': 'Fabio Salvatore', 'Initials': 'FS', 'LastName': 'Macaluso', 'Affiliation': 'Inflammatory bowel disease Unit, A.O.O.R. ""Villa Sofia-Cervello"", Viale Strasburgo 233, 90146 Palermo, Italy. Electronic address: fsmacaluso@gmail.com.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Ventimiglia', 'Affiliation': 'Inflammatory bowel disease Unit, A.O.O.R. ""Villa Sofia-Cervello"", Viale Strasburgo 233, 90146 Palermo, Italy.'}, {'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Fries', 'Affiliation': 'Inflammatory bowel disease Unit, A.O.U. Policlinico ""G. Martino"", Messina, Italy.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Viola', 'Affiliation': 'Inflammatory bowel disease Unit, A.O.U. Policlinico ""G. Martino"", Messina, Italy.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Cappello', 'Affiliation': 'Gastroenterology and Hepatology Unit, A.O.U. Policlinico ""G. Giaccone"", Palermo, Italy.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Scrivo', 'Affiliation': 'Gastroenterology and Hepatology Unit, A.O.U. Policlinico ""G. Giaccone"", Palermo, Italy.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Magnano', 'Affiliation': 'Gastroenterology Unit, A.O.U. Policlinico ""Vittorio Emanuele"", Catania, Italy.'}, {'ForeName': 'Dario', 'Initials': 'D', 'LastName': 'Pluchino', 'Affiliation': 'Gastroenterology Unit, A.O.U. Policlinico ""Vittorio Emanuele"", Catania, Italy.'}, {'ForeName': 'Salvatore', 'Initials': 'S', 'LastName': 'Camilleri', 'Affiliation': 'Gastroenterology Unit, A.O.O.R. ""S. Elia- M. Raimondi"", Caltanissetta, Italy.'}, {'ForeName': 'Serena', 'Initials': 'S', 'LastName': 'Garufi', 'Affiliation': 'Gastroenterology Unit, A.O.O.R. ""S. Elia- M. Raimondi"", Caltanissetta, Italy.'}, {'ForeName': 'Roberto Di', 'Initials': 'RD', 'LastName': 'Mitri', 'Affiliation': 'Gastroenterology and endoscopy Unit, A.R.N.A.S. ""Civico Di Cristina Benfratelli"", Palermo, Italy.'}, {'ForeName': 'Filippo', 'Initials': 'F', 'LastName': 'Mocciaro', 'Affiliation': 'Gastroenterology and endoscopy Unit, A.R.N.A.S. ""Civico Di Cristina Benfratelli"", Palermo, Italy.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Magrì', 'Affiliation': 'Gastroenterology Unit, A.O. ""Santa Marta e S. Venera"", Acireale, Italy.'}, {'ForeName': 'Concetta', 'Initials': 'C', 'LastName': 'Ferracane', 'Affiliation': 'Gastroenterology Unit, A.O. ""Santa Marta e S. Venera"", Acireale, Italy.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Citrano', 'Affiliation': 'Pediatrics Unit, A.O.O.R. ""Villa Sofia-Cervello"", Palermo, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Graziano', 'Affiliation': 'Pediatrics Unit, A.O.O.R. ""Villa Sofia-Cervello"", Palermo, Italy.'}, {'ForeName': 'Carmelo', 'Initials': 'C', 'LastName': 'Bertolami', 'Affiliation': 'Gastroenterology Unit, A.O.O.R. ""Papardo Piemonte"", Messina, Italy.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Renna', 'Affiliation': 'Inflammatory bowel disease Unit, A.O.O.R. ""Villa Sofia-Cervello"", Viale Strasburgo 233, 90146 Palermo, Italy.'}, {'ForeName': 'Rosalba', 'Initials': 'R', 'LastName': 'Orlando', 'Affiliation': 'Inflammatory bowel disease Unit, A.O.O.R. ""Villa Sofia-Cervello"", Viale Strasburgo 233, 90146 Palermo, Italy.'}, {'ForeName': 'Giulia', 'Initials': 'G', 'LastName': 'Rizzuto', 'Affiliation': 'Inflammatory bowel disease Unit, A.O.O.R. ""Villa Sofia-Cervello"", Viale Strasburgo 233, 90146 Palermo, Italy.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Cottone', 'Affiliation': 'Inflammatory bowel disease Unit, A.O.O.R. ""Villa Sofia-Cervello"", Viale Strasburgo 233, 90146 Palermo, Italy.'}, {'ForeName': 'Ambrogio', 'Initials': 'A', 'LastName': 'Orlando', 'Affiliation': 'Inflammatory bowel disease Unit, A.O.O.R. ""Villa Sofia-Cervello"", Viale Strasburgo 233, 90146 Palermo, Italy.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Digestive and liver disease : official journal of the Italian Society of Gastroenterology and the Italian Association for the Study of the Liver,['10.1016/j.dld.2020.06.014'] 2229,32601075,Randomized Phase II Trial of Carboplatin-Paclitaxel Compared with Carboplatin-Paclitaxel-Trastuzumab in Advanced (Stage III-IV) or Recurrent Uterine Serous Carcinomas that Overexpress Her2/Neu (NCT01367002): Updated Overall Survival Analysis.,"PURPOSE Uterine-serous-carcinoma (USC) is an aggressive variant of endometrial cancer. On the basis of preliminary results of a multicenter, randomized phase II trial, trastuzumab (T), a humanized-mAb targeting Her2/Neu, in combination with carboplatin/paclitaxel (C/P), is recognized as an alternative in treating advanced/recurrent HER2/Neu-positive USC. We report the updated survival analysis of NCT01367002. PATIENTS AND METHODS Eligible patients had stage III to IV or recurrent disease. Participants were randomized 1:1 to receive C/P for six cycles ± T followed by maintenance T until progression or toxicity. Progression-free survival (PFS) was the primary endpoint; overall survival (OS) and toxicity were secondary endpoints. RESULTS Sixty-one patients were randomized. After a median-follow-up of 25.9 months, 43 progressions and 38 deaths occurred among 58 evaluable patients. Updated median-PFS continued to favor the T-arm, with medians of 8.0 months versus 12.9 months in the control and T-arms (HR = 0.46; 90% CI, 0.28-0.76; P = 0.005). Median-PFS was 9.3 months versus 17.7 months among 41 patients with stage III to IV disease undergoing primary treatment (HR = 0.44; 90% CI, 0.23-0.83; P = 0.015), and 7.0 months versus 9.2 months among 17 patients with recurrent disease (HR = 0.12; 90% CI, 0.03-0.48; P = 0.004). OS was higher in the T compared with the control arm, with medians of 29.6 months versus 24.4 months (HR = 0.58; 90% CI, 0.34-0.99; P = 0.046). The benefit was most notable in those with stage III to IV disease, with survival median not reached in the T-arm versus 24.4 months in the control arm (HR = 0.49; 90% CI, 0.25-0.97; P = 0.041). Toxicity was not different between arms. CONCLUSIONS Addition of T to C/P increased PFS and OS in women with advanced/recurrent HER2/Neu-positive USC, with the greatest benefit seen for the treatment of stage III to IV disease.",2020,"OS was higher in the T compared with the control arm, with medians of 29.6 months versus 24.4 months (HR = 0.58; 90% CI, 0.34-0.99; P = 0.046).","['Sixty-one patients were randomized', 'Advanced (Stage III-IV) or Recurrent Uterine Serous Carcinomas that Overexpress Her2/Neu (NCT01367002', 'Eligible patients had stage III to IV or recurrent disease']","['carboplatin/paclitaxel (C/P', 'Carboplatin-Paclitaxel', 'trastuzumab (T', 'Carboplatin-Paclitaxel-Trastuzumab']","['Median-PFS', 'Progression-free survival (PFS', 'OS', 'Toxicity', 'PFS and OS', 'survival median', 'overall survival (OS) and toxicity']","[{'cui': 'C4517832', 'cui_str': '61'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0854924', 'cui_str': 'Papillary serous endometrial carcinoma'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0277556', 'cui_str': 'Recurrent disease'}]","[{'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0728747', 'cui_str': 'trastuzumab'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0040539', 'cui_str': 'TO'}]",41.0,0.181913,"OS was higher in the T compared with the control arm, with medians of 29.6 months versus 24.4 months (HR = 0.58; 90% CI, 0.34-0.99; P = 0.046).","[{'ForeName': 'Amanda N', 'Initials': 'AN', 'LastName': 'Fader', 'Affiliation': 'John Hopkins School of Medicine, Baltimore, Maryland.'}, {'ForeName': 'Dana M', 'Initials': 'DM', 'LastName': 'Roque', 'Affiliation': 'University of Maryland, Baltimore, Maryland.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Siegel', 'Affiliation': 'University of Arkansas for Medical Sciences, Little Rock, Arkansas.'}, {'ForeName': 'Natalia', 'Initials': 'N', 'LastName': 'Buza', 'Affiliation': 'Yale University, New Haven, Connecticut.'}, {'ForeName': 'Pei', 'Initials': 'P', 'LastName': 'Hui', 'Affiliation': 'Yale University, New Haven, Connecticut.'}, {'ForeName': 'Osama', 'Initials': 'O', 'LastName': 'Abdelghany', 'Affiliation': 'Yale University, New Haven, Connecticut.'}, {'ForeName': 'Setsuko', 'Initials': 'S', 'LastName': 'Chambers', 'Affiliation': 'University of Arizona, Tucson, Arizona.'}, {'ForeName': 'Angeles Alvarez', 'Initials': 'AA', 'LastName': 'Secord', 'Affiliation': 'Duke University School of Medicine, Durham, North Caroline.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Havrilesky', 'Affiliation': 'Duke University School of Medicine, Durham, North Caroline.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': ""O'Malley"", 'Affiliation': 'The Ohio State University School of Medicine, Columbus, Ohio.'}, {'ForeName': 'Floor J', 'Initials': 'FJ', 'LastName': 'Backes', 'Affiliation': 'The Ohio State University School of Medicine, Columbus, Ohio.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Nevadunsky', 'Affiliation': 'Albert Einstein College/Montefiore Medical Center, Bronx, New York.'}, {'ForeName': 'Babak', 'Initials': 'B', 'LastName': 'Edraki', 'Affiliation': 'John Muir Medical Center, Walnut Creek, California.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Pikaart', 'Affiliation': 'Penrose Cancer Center-St. Francis, Colorado Springs, Colorado.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Lowery', 'Affiliation': 'Walter Reed Medical Center, Bethesda, Maryland.'}, {'ForeName': 'Karim', 'Initials': 'K', 'LastName': 'ElSahwi', 'Affiliation': 'Hackensack Meridian Health, Neptune, New Jersey.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Celano', 'Affiliation': 'Greater Baltimore Medical Center, Baltimore, Maryland.'}, {'ForeName': 'Stefania', 'Initials': 'S', 'LastName': 'Bellone', 'Affiliation': 'Yale University, New Haven, Connecticut.'}, {'ForeName': 'Masoud', 'Initials': 'M', 'LastName': 'Azodi', 'Affiliation': 'Yale University, New Haven, Connecticut.'}, {'ForeName': 'Babak', 'Initials': 'B', 'LastName': 'Litkouhi', 'Affiliation': ""Stanford Women's Cancer Center, Palo Alto, California.""}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Ratner', 'Affiliation': 'Yale University, New Haven, Connecticut.'}, {'ForeName': 'Dan-Arin', 'Initials': 'DA', 'LastName': 'Silasi', 'Affiliation': 'Yale University, New Haven, Connecticut.'}, {'ForeName': 'Peter E', 'Initials': 'PE', 'LastName': 'Schwartz', 'Affiliation': 'Yale University, New Haven, Connecticut.'}, {'ForeName': 'Alessandro D', 'Initials': 'AD', 'LastName': 'Santin', 'Affiliation': 'Yale University, New Haven, Connecticut. alessandro.santin@yale.edu.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-20-0953'] 2230,32601101,Colon capsule endoscopy in colorectal cancer screening: a randomised controlled trial.,"INTRODUCTION The use of capsule endoscopy has become an approved method in small bowel diagnostics, but the same level of integration is not seen in large bowel diagnostics. We will use colon capsule endoscopy (CCE) as a filter test in colorectal cancer (CRC) screening between the faecal immunochemical test (FIT) and colonoscopy. We aim to investigate the clinical performance, population acceptability, and economic implications of the procedure in a large-scale clinical trial. METHODS AND ANALYSIS We will randomly allocate 124 214 Danish citizens eligible for participation in the national CRC screening programme within the Region of Southern Denmark to either an intervention group or a control group. Prior to submitting a FIT, citizens randomised to the intervention group will be informed about their opportunity to undergo CCE, instead of colonoscopy, if the FIT is positive. Suspected cancers; >3 adenomas <10 mm in size, 1 adenoma >10 mm in size or >4 adenomas regardless of size, detected during CCE will generate an invitation to colonoscopy as per regular screening guidelines, whereas citizens with suspected low risk polyps will re-enter the biennial screening programme. Citizens with no CCE findings will be excluded from screening for 8 years. In the control group, citizens will follow standard screening procedures. ETHICS AND DISSEMINATION All participants must consent prior to capsule ingestion. All collected data will be handled and stored in accordance with current data protection legislation. Approvals from the regional ethics committee (ref. S-20190100) and the Danish data protection agency have been obtained (ref. 19/29858). TRIAL REGISTRATION DETAILS The study has been registered with ClinicalTrials.gov under: NCT04049357.",2020,We will randomly allocate 124 214 Danish citizens eligible for participation in the national CRC screening programme within the Region of Southern Denmark to either an intervention group or a control group.,"['colorectal cancer screening', '124 214 Danish citizens eligible for participation in the national CRC screening programme within the Region of Southern Denmark to either an intervention group or a control group']","['Colon capsule endoscopy', 'colon capsule endoscopy (CCE']",[],"[{'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C4517553', 'cui_str': '124'}, {'cui': 'C0010969', 'cui_str': 'Danish language'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0009368', 'cui_str': 'Colonic'}, {'cui': 'C1721048', 'cui_str': 'Capsule endoscopy'}]",[],124214.0,0.249155,We will randomly allocate 124 214 Danish citizens eligible for participation in the national CRC screening programme within the Region of Southern Denmark to either an intervention group or a control group.,"[{'ForeName': 'Lasse', 'Initials': 'L', 'LastName': 'Kaalby', 'Affiliation': 'Department of Surgery, Odense University Hospital, Svendborg, Denmark lkm@rsyd.dk.'}, {'ForeName': 'Ulrik', 'Initials': 'U', 'LastName': 'Deding', 'Affiliation': 'Department of Surgery, Odense University Hospital, Svendborg, Denmark.'}, {'ForeName': 'Morten', 'Initials': 'M', 'LastName': 'Kobaek-Larsen', 'Affiliation': 'Department of Surgery, Odense University Hospital, Svendborg, Denmark.'}, {'ForeName': 'Anne-Line Volden', 'Initials': 'AV', 'LastName': 'Havshoi', 'Affiliation': 'Department of Surgery, Odense University Hospital, Svendborg, Denmark.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Zimmermann-Nielsen', 'Affiliation': 'Department of Surgery, Odense University Hospital, Svendborg, Denmark.'}, {'ForeName': 'Marianne Kirstine', 'Initials': 'MK', 'LastName': 'Thygesen', 'Affiliation': 'Department of Surgery, Odense University Hospital, Svendborg, Denmark.'}, {'ForeName': 'Rasmus', 'Initials': 'R', 'LastName': 'Kroeijer', 'Affiliation': 'Department of Surgery, Southwest Jutland Hospital Esbjerg, Esbjerg, Denmark.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Bjørsum-Meyer', 'Affiliation': 'Department of Surgery, Odense University Hospital, Svendborg, Denmark.'}, {'ForeName': 'Gunnar', 'Initials': 'G', 'LastName': 'Baatrup', 'Affiliation': 'Department of Surgery, Odense University Hospital, Svendborg, Denmark.'}]",BMJ open gastroenterology,['10.1136/bmjgast-2020-000411'] 2231,32601120,Deep Brain Stimulation in Early-Stage Parkinson's Disease: Five Year Outcomes.,"OBJECTIVE To report five-year outcomes from the subthalmic nucleus (STN) deep brain stimulation (DBS) in early-stage Parkinson's disease (PD) pilot clinical trial. METHODS The pilot was a prospective, single-blind clinical trial that randomized early-stage PD subjects (Hoehn & Yahr II off medications) to receive bilateral STN DBS plus optimal drug therapy (ODT) versus ODT alone (IDEG050016, NCT0282152, IRB040797). Subjects who completed the two-year trial participated in this observational follow-up study which included annual outpatient visits through five years. This analysis includes 28 subjects who were taking PD medications six months-four years at enrollment. Outcomes were analyzed using both proportional odds logistic regression and linear mixed effects models. RESULTS Early STN DBS+ODT subjects required lower levodopa equivalent daily doses (P=0.04, β = -240mg, 95%CI: -471 to -8) and had 0.06 times the odds of requiring polypharmacy at five years compared to early ODT subjects (P=0.01, OR=0.06, 95%CI: 0.00 to 0.65). The odds of having worse rest tremor for early STN DBS+ODT subjects were 0.21 times those of early ODT subjects (P<0.001, OR=0.21, 95%CI: 0.09 to 0.45). The safety profile was similar between groups. CONCLUSIONS These results suggest that early DBS reduces the need for and complexity of PD medications while providing long-term motor benefit over standard medical therapy. Further investigation is warranted, and the FDA has approved the conduct of a prospective, multicenter, pivotal clinical trial of DBS in early-stage PD (IDEG050016). CLASSIFICATION OF EVIDENCE This study provides Class II evidence that DBS implanted in early-stage Parkinson disease decreases the risk of disease progression and polypharmacy compared to optimal medical therapy alone.",2020,"RESULTS Early STN DBS+ODT subjects required lower levodopa equivalent daily doses (P=0.04, β = -240mg, 95%CI: -471 to -8) and had 0.06 times the odds of requiring polypharmacy at five years compared to early ODT subjects (P=0.01, OR=0.06, 95%CI: 0.00 to 0.65).","['Subjects who completed the two-year trial participated in this observational follow-up study which included annual outpatient visits through five years', ""Early-Stage Parkinson's Disease"", '28 subjects who were taking PD medications six months-four years at enrollment', ""early-stage Parkinson's disease (PD""]","['subthalmic nucleus (STN) deep brain stimulation (DBS', 'bilateral STN DBS plus optimal drug therapy (ODT) versus ODT']",['safety profile'],"[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1518527', 'cui_str': 'Observational Study'}, {'cui': 'C0016441', 'cui_str': 'Followup Studies'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C2363430', 'cui_str': 'Early stage'}, {'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}]","[{'cui': 'C0007610', 'cui_str': 'Nucleus'}, {'cui': 'C0394162', 'cui_str': 'Deep brain stimulation'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.127564,"RESULTS Early STN DBS+ODT subjects required lower levodopa equivalent daily doses (P=0.04, β = -240mg, 95%CI: -471 to -8) and had 0.06 times the odds of requiring polypharmacy at five years compared to early ODT subjects (P=0.01, OR=0.06, 95%CI: 0.00 to 0.65).","[{'ForeName': 'Mallory L', 'Initials': 'ML', 'LastName': 'Hacker', 'Affiliation': 'Department of Neurology, Vanderbilt University Medical Center Mallory.Hacker@vumc.org.'}, {'ForeName': 'Maxim', 'Initials': 'M', 'LastName': 'Turchan', 'Affiliation': 'Department of Neurology, Vanderbilt University Medical Center.'}, {'ForeName': 'Lauren E', 'Initials': 'LE', 'LastName': 'Heusinkveld', 'Affiliation': 'Department of Neurology, Vanderbilt University Medical Center.'}, {'ForeName': 'Amanda D', 'Initials': 'AD', 'LastName': 'Currie', 'Affiliation': 'Department of Neurology, Vanderbilt University Medical Center.'}, {'ForeName': 'Sarah H', 'Initials': 'SH', 'LastName': 'Millan', 'Affiliation': 'Department of Neurology, Vanderbilt University Medical Center.'}, {'ForeName': 'Anna L', 'Initials': 'AL', 'LastName': 'Molinari', 'Affiliation': 'Department of Neurology, Vanderbilt University Medical Center.'}, {'ForeName': 'Peter E', 'Initials': 'PE', 'LastName': 'Konrad', 'Affiliation': 'Department of Neurosurgery, Vanderbilt University Medical Center.'}, {'ForeName': 'Thomas L', 'Initials': 'TL', 'LastName': 'Davis', 'Affiliation': 'Department of Neurology, Vanderbilt University Medical Center.'}, {'ForeName': 'Fenna T', 'Initials': 'FT', 'LastName': 'Phibbs', 'Affiliation': 'Department of Neurology, Vanderbilt University Medical Center.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Hedera', 'Affiliation': 'Department of Neurology, Vanderbilt University Medical Center.'}, {'ForeName': 'Kevin R', 'Initials': 'KR', 'LastName': 'Cannard', 'Affiliation': 'Department of Neurology, Walter Reed National Military Center.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Department of Biostatistics, Vanderbilt University Medical Center.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Charles', 'Affiliation': 'Department of Neurology, Vanderbilt University Medical Center.'}]",Neurology,['10.1212/WNL.0000000000009946'] 2232,32601123,Does screening for adverse effects improve health outcomes in epilepsy? A randomized trial.,"OBJECTIVE To determine whether systematic screening for adverse effects of antiepileptic drugs (AEDs) reduces toxicity burden and improves health-related quality of life in patients with epilepsy. METHODS Consecutive patients with uncontrolled seizures aged ≥16 years and a high Adverse Event Profile (AEP) score were randomized to 2 groups and followed up for 18 months at 11 referral centers. AEP scores were made available to treating physicians at all visits in the intervention group, but not in the control group. Co-primary endpoints were changes in AEP scores and Quality of Life Inventory for Epilepsy-31 (QOLIE-31) scores. RESULTS Of 809 enrolled patients able to complete the AEP questionnaire, 222 had AEP scores ≥45 and were randomized to the intervention (n = 111) or control group (n = 111). A total of 206 patients completed the 18-month follow-up. Compared with baseline, AEP scores decreased on average by 7.2% at 6 months, 12.1% at 12 months, and 13.8% at 18 months in the intervention group ( p < 0.0001), and by 7.7% at 6 months, 9.2% at 12 months, and 12.0% at 18 months in controls ( p < 0.0001). QOLIE-31 scores also improved from baseline to final visit, with a mean 20.7% increase in the intervention group and a mean 24.9% increase in the control group ( p < 0.0001). However, there were no statistically significant differences in outcomes between groups for the 2 co-primary variables. CONCLUSIONS Contrary to findings from a previous study, systematic screening for adverse effects of AEDs using AEP scores did not lead to a reduced burden of toxicity over usual physician treatment. ITALIAN MEDICINES AGENCY AIFA IDENTIFIER FARM52K2WM_003. CLINICALTRIALSGOV IDENTIFIER NCT03939507 (registered retrospectively in 2019; the study was conducted during the 2006-2009 period and registration of clinical trials was not a widely established practice when this study was initiated). CLASSIFICATION OF EVIDENCE This study provides Class II evidence that the additional collection of formal questionnaires regarding adverse effects of AEDs does not reduce toxicity burden over usual physician treatment.",2020,"AEP scores were made available to treating physicians at all visits in the intervention group, but not in the control group.","['206 patients completed the 18-month follow-up', 'Consecutive patients with uncontrolled seizures aged ≥16 years and a high Adverse Event Profile (AEP) score were randomized to 2 groups and followed up for 18 months at 11 referral centers', '809 enrolled patients able to complete the AEP questionnaire, 222 had AEP scores ≥45', 'patients with epilepsy', 'NCT03939507 (registered retrospectively in 2019; the study was conducted during the 2006-2009 period and registration of clinical trials was not a widely established practice when this study was initiated']",['antiepileptic drugs (AEDs'],"['toxicity burden', 'toxicity', 'toxicity burden and improves health-related quality of life', 'AEP scores and Quality of Life Inventory for Epilepsy-31 (QOLIE-31) scores', 'QOLIE-31 scores', 'AEP scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0205318', 'cui_str': 'Uncontrolled'}, {'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0014544', 'cui_str': 'Epilepsy'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0443211', 'cui_str': 'Established'}]","[{'cui': 'C0003299', 'cui_str': 'ANTIEPILEPTICS'}]","[{'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0014544', 'cui_str': 'Epilepsy'}]",809.0,0.161817,"AEP scores were made available to treating physicians at all visits in the intervention group, but not in the control group.","[{'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Franco', 'Affiliation': 'From the Clinical Pharmacology Unit (V.F., G.G., E.P.), University of Pavia; IRCCS Mondino Foundation (V.F., C.F., C.A.G., E.P.), Pavia; Epilepsy Center (M.P.C.), San Paolo Hospital, Milan; Magna Graecia University (G.D.S.), Catanzaro; School of Hospital Pharmacy (G.F.), University of Milan; Epilepsy Center (A.L.N.), Neurology Hospital ""Amaducci,"" University of Bari; Unit of Neurology (E.R.), Usl Centro Toscana Health Authority, Prato; University of Foggia (L.M.S.); Epilepsy Center (S.S.), Federico II University, Naples; and IRCCS (P.T.), Institute of Neurological Sciences of Bologna and Department of Biomedical and Neuromotor Sciences, University of Bologna, Italy. valentina.franco@unipv.it.'}, {'ForeName': 'Maria Paola', 'Initials': 'MP', 'LastName': 'Canevini', 'Affiliation': 'From the Clinical Pharmacology Unit (V.F., G.G., E.P.), University of Pavia; IRCCS Mondino Foundation (V.F., C.F., C.A.G., E.P.), Pavia; Epilepsy Center (M.P.C.), San Paolo Hospital, Milan; Magna Graecia University (G.D.S.), Catanzaro; School of Hospital Pharmacy (G.F.), University of Milan; Epilepsy Center (A.L.N.), Neurology Hospital ""Amaducci,"" University of Bari; Unit of Neurology (E.R.), Usl Centro Toscana Health Authority, Prato; University of Foggia (L.M.S.); Epilepsy Center (S.S.), Federico II University, Naples; and IRCCS (P.T.), Institute of Neurological Sciences of Bologna and Department of Biomedical and Neuromotor Sciences, University of Bologna, Italy.'}, {'ForeName': 'Giovambattista', 'Initials': 'G', 'LastName': 'De Sarro', 'Affiliation': 'From the Clinical Pharmacology Unit (V.F., G.G., E.P.), University of Pavia; IRCCS Mondino Foundation (V.F., C.F., C.A.G., E.P.), Pavia; Epilepsy Center (M.P.C.), San Paolo Hospital, Milan; Magna Graecia University (G.D.S.), Catanzaro; School of Hospital Pharmacy (G.F.), University of Milan; Epilepsy Center (A.L.N.), Neurology Hospital ""Amaducci,"" University of Bari; Unit of Neurology (E.R.), Usl Centro Toscana Health Authority, Prato; University of Foggia (L.M.S.); Epilepsy Center (S.S.), Federico II University, Naples; and IRCCS (P.T.), Institute of Neurological Sciences of Bologna and Department of Biomedical and Neuromotor Sciences, University of Bologna, Italy.'}, {'ForeName': 'Cinzia', 'Initials': 'C', 'LastName': 'Fattore', 'Affiliation': 'From the Clinical Pharmacology Unit (V.F., G.G., E.P.), University of Pavia; IRCCS Mondino Foundation (V.F., C.F., C.A.G., E.P.), Pavia; Epilepsy Center (M.P.C.), San Paolo Hospital, Milan; Magna Graecia University (G.D.S.), Catanzaro; School of Hospital Pharmacy (G.F.), University of Milan; Epilepsy Center (A.L.N.), Neurology Hospital ""Amaducci,"" University of Bari; Unit of Neurology (E.R.), Usl Centro Toscana Health Authority, Prato; University of Foggia (L.M.S.); Epilepsy Center (S.S.), Federico II University, Naples; and IRCCS (P.T.), Institute of Neurological Sciences of Bologna and Department of Biomedical and Neuromotor Sciences, University of Bologna, Italy.'}, {'ForeName': 'Guido', 'Initials': 'G', 'LastName': 'Fedele', 'Affiliation': 'From the Clinical Pharmacology Unit (V.F., G.G., E.P.), University of Pavia; IRCCS Mondino Foundation (V.F., C.F., C.A.G., E.P.), Pavia; Epilepsy Center (M.P.C.), San Paolo Hospital, Milan; Magna Graecia University (G.D.S.), Catanzaro; School of Hospital Pharmacy (G.F.), University of Milan; Epilepsy Center (A.L.N.), Neurology Hospital ""Amaducci,"" University of Bari; Unit of Neurology (E.R.), Usl Centro Toscana Health Authority, Prato; University of Foggia (L.M.S.); Epilepsy Center (S.S.), Federico II University, Naples; and IRCCS (P.T.), Institute of Neurological Sciences of Bologna and Department of Biomedical and Neuromotor Sciences, University of Bologna, Italy.'}, {'ForeName': 'Carlo Andrea', 'Initials': 'CA', 'LastName': 'Galimberti', 'Affiliation': 'From the Clinical Pharmacology Unit (V.F., G.G., E.P.), University of Pavia; IRCCS Mondino Foundation (V.F., C.F., C.A.G., E.P.), Pavia; Epilepsy Center (M.P.C.), San Paolo Hospital, Milan; Magna Graecia University (G.D.S.), Catanzaro; School of Hospital Pharmacy (G.F.), University of Milan; Epilepsy Center (A.L.N.), Neurology Hospital ""Amaducci,"" University of Bari; Unit of Neurology (E.R.), Usl Centro Toscana Health Authority, Prato; University of Foggia (L.M.S.); Epilepsy Center (S.S.), Federico II University, Naples; and IRCCS (P.T.), Institute of Neurological Sciences of Bologna and Department of Biomedical and Neuromotor Sciences, University of Bologna, Italy.'}, {'ForeName': 'Giuliana', 'Initials': 'G', 'LastName': 'Gatti', 'Affiliation': 'From the Clinical Pharmacology Unit (V.F., G.G., E.P.), University of Pavia; IRCCS Mondino Foundation (V.F., C.F., C.A.G., E.P.), Pavia; Epilepsy Center (M.P.C.), San Paolo Hospital, Milan; Magna Graecia University (G.D.S.), Catanzaro; School of Hospital Pharmacy (G.F.), University of Milan; Epilepsy Center (A.L.N.), Neurology Hospital ""Amaducci,"" University of Bari; Unit of Neurology (E.R.), Usl Centro Toscana Health Authority, Prato; University of Foggia (L.M.S.); Epilepsy Center (S.S.), Federico II University, Naples; and IRCCS (P.T.), Institute of Neurological Sciences of Bologna and Department of Biomedical and Neuromotor Sciences, University of Bologna, Italy.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'La Neve', 'Affiliation': 'From the Clinical Pharmacology Unit (V.F., G.G., E.P.), University of Pavia; IRCCS Mondino Foundation (V.F., C.F., C.A.G., E.P.), Pavia; Epilepsy Center (M.P.C.), San Paolo Hospital, Milan; Magna Graecia University (G.D.S.), Catanzaro; School of Hospital Pharmacy (G.F.), University of Milan; Epilepsy Center (A.L.N.), Neurology Hospital ""Amaducci,"" University of Bari; Unit of Neurology (E.R.), Usl Centro Toscana Health Authority, Prato; University of Foggia (L.M.S.); Epilepsy Center (S.S.), Federico II University, Naples; and IRCCS (P.T.), Institute of Neurological Sciences of Bologna and Department of Biomedical and Neuromotor Sciences, University of Bologna, Italy.'}, {'ForeName': 'Eleonora', 'Initials': 'E', 'LastName': 'Rosati', 'Affiliation': 'From the Clinical Pharmacology Unit (V.F., G.G., E.P.), University of Pavia; IRCCS Mondino Foundation (V.F., C.F., C.A.G., E.P.), Pavia; Epilepsy Center (M.P.C.), San Paolo Hospital, Milan; Magna Graecia University (G.D.S.), Catanzaro; School of Hospital Pharmacy (G.F.), University of Milan; Epilepsy Center (A.L.N.), Neurology Hospital ""Amaducci,"" University of Bari; Unit of Neurology (E.R.), Usl Centro Toscana Health Authority, Prato; University of Foggia (L.M.S.); Epilepsy Center (S.S.), Federico II University, Naples; and IRCCS (P.T.), Institute of Neurological Sciences of Bologna and Department of Biomedical and Neuromotor Sciences, University of Bologna, Italy.'}, {'ForeName': 'Luigi Maria', 'Initials': 'LM', 'LastName': 'Specchio', 'Affiliation': 'From the Clinical Pharmacology Unit (V.F., G.G., E.P.), University of Pavia; IRCCS Mondino Foundation (V.F., C.F., C.A.G., E.P.), Pavia; Epilepsy Center (M.P.C.), San Paolo Hospital, Milan; Magna Graecia University (G.D.S.), Catanzaro; School of Hospital Pharmacy (G.F.), University of Milan; Epilepsy Center (A.L.N.), Neurology Hospital ""Amaducci,"" University of Bari; Unit of Neurology (E.R.), Usl Centro Toscana Health Authority, Prato; University of Foggia (L.M.S.); Epilepsy Center (S.S.), Federico II University, Naples; and IRCCS (P.T.), Institute of Neurological Sciences of Bologna and Department of Biomedical and Neuromotor Sciences, University of Bologna, Italy.'}, {'ForeName': 'Salvatore', 'Initials': 'S', 'LastName': 'Striano', 'Affiliation': 'From the Clinical Pharmacology Unit (V.F., G.G., E.P.), University of Pavia; IRCCS Mondino Foundation (V.F., C.F., C.A.G., E.P.), Pavia; Epilepsy Center (M.P.C.), San Paolo Hospital, Milan; Magna Graecia University (G.D.S.), Catanzaro; School of Hospital Pharmacy (G.F.), University of Milan; Epilepsy Center (A.L.N.), Neurology Hospital ""Amaducci,"" University of Bari; Unit of Neurology (E.R.), Usl Centro Toscana Health Authority, Prato; University of Foggia (L.M.S.); Epilepsy Center (S.S.), Federico II University, Naples; and IRCCS (P.T.), Institute of Neurological Sciences of Bologna and Department of Biomedical and Neuromotor Sciences, University of Bologna, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Tinuper', 'Affiliation': 'From the Clinical Pharmacology Unit (V.F., G.G., E.P.), University of Pavia; IRCCS Mondino Foundation (V.F., C.F., C.A.G., E.P.), Pavia; Epilepsy Center (M.P.C.), San Paolo Hospital, Milan; Magna Graecia University (G.D.S.), Catanzaro; School of Hospital Pharmacy (G.F.), University of Milan; Epilepsy Center (A.L.N.), Neurology Hospital ""Amaducci,"" University of Bari; Unit of Neurology (E.R.), Usl Centro Toscana Health Authority, Prato; University of Foggia (L.M.S.); Epilepsy Center (S.S.), Federico II University, Naples; and IRCCS (P.T.), Institute of Neurological Sciences of Bologna and Department of Biomedical and Neuromotor Sciences, University of Bologna, Italy.'}, {'ForeName': 'Emilio', 'Initials': 'E', 'LastName': 'Perucca', 'Affiliation': 'From the Clinical Pharmacology Unit (V.F., G.G., E.P.), University of Pavia; IRCCS Mondino Foundation (V.F., C.F., C.A.G., E.P.), Pavia; Epilepsy Center (M.P.C.), San Paolo Hospital, Milan; Magna Graecia University (G.D.S.), Catanzaro; School of Hospital Pharmacy (G.F.), University of Milan; Epilepsy Center (A.L.N.), Neurology Hospital ""Amaducci,"" University of Bari; Unit of Neurology (E.R.), Usl Centro Toscana Health Authority, Prato; University of Foggia (L.M.S.); Epilepsy Center (S.S.), Federico II University, Naples; and IRCCS (P.T.), Institute of Neurological Sciences of Bologna and Department of Biomedical and Neuromotor Sciences, University of Bologna, Italy.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Neurology,['10.1212/WNL.0000000000009880'] 2233,32601329,Suture type used for perineal injury repair and sexual function: a randomised controlled trial.,"The type of suture used to repair perineal injury may be associated with this healing process and subsequent sexual function. This study aims to assess whether the suture technique used (continuous or interrupted) has an impact on a woman's sexual function following childbirth. A single-blind randomised clinical trial was conducted with primiparous women who had experienced a perineal injury during childbirth. A computer-generated random number table was applied to allocate women to each group. Data were collected on sociodemographic variables, variables associated with childbirth, and outcomes during the 3 months after childbirth. Mean difference was used to assess the influence of the suture type on outcomes. Multivariate analyses were carried out to adjust for unbalanced variables after randomisation. Seventy women participated in the intervention group (continuous suture) and 64 women in the control group (interrupted suture). The women in the intervention group scored high for sexual desire, adjusted mean difference (aMD) = 1.8, 95% CI = 1.1-2.6 (p < 0.001); the same happened with arousal (aMD = 1.7, 95% CI = 0.8-2.5, p < 0.001). In the intervention group, orgasm was more easily reached, aMD = 0.8, 95% CI = 0.4-1.1 (p < 0.001). Women who received a continuous suture indicated they felt less discomfort (p < 0.001). Women who had a continuous suture reported better postpartum sexual function.Trial registration: ClinicalTrials.gov NCT03825211 posted 31/01/ 2019.",2020,"In the intervention group, orgasm was more easily reached, aMD = 0.8, 95% CI = 0.4-1.1 (p < 0.001).","['primiparous women who had experienced a perineal injury during childbirth', 'Seventy women participated in the intervention group (continuous suture) and 64 women in the', ""woman's sexual function following childbirth""]","['suture technique used (continuous or interrupted', 'control group (interrupted suture', 'Suture type used for perineal injury repair and sexual function']","['discomfort', 'sexual desire', 'postpartum sexual function']","[{'cui': 'C0033150', 'cui_str': 'Para 1'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C3544174', 'cui_str': 'Perineal injury'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C0278092', 'cui_str': 'Sexual function'}, {'cui': 'C0231290', 'cui_str': 'Status post'}]","[{'cui': 'C0038968', 'cui_str': 'Suturing techniques'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0443239', 'cui_str': 'Interrupted'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C0502420', 'cui_str': 'Suture structure'}, {'cui': 'C3544174', 'cui_str': 'Perineal injury'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0278092', 'cui_str': 'Sexual function'}]","[{'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0023618', 'cui_str': 'Libido'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C0278092', 'cui_str': 'Sexual function'}]",70.0,0.282807,"In the intervention group, orgasm was more easily reached, aMD = 0.8, 95% CI = 0.4-1.1 (p < 0.001).","[{'ForeName': 'Juan Miguel', 'Initials': 'JM', 'LastName': 'Martínez-Galiano', 'Affiliation': 'Department of Nursing, University of Jaen, Jaén, Spain. juanmimartinezg@hotmail.com.'}, {'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Arredondo-López', 'Affiliation': 'Andalusian Health Service, Andalucia, Spain.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Hidalgo-Ruiz', 'Affiliation': 'Andalusian Health Service, Andalucia, Spain.'}, {'ForeName': 'Alicia', 'Initials': 'A', 'LastName': 'Narvaez-Traverso', 'Affiliation': 'Andalusian Health Service, Andalucia, Spain.'}, {'ForeName': 'Inmaculada', 'Initials': 'I', 'LastName': 'Lopez-Morón', 'Affiliation': 'Andalusian Health Service, Andalucia, Spain.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Delgado-Rodriguez', 'Affiliation': 'CIBER Epidemiology and Public Health (CIBERESP), Madrid, Spain.'}]",Scientific reports,['10.1038/s41598-020-67659-2'] 2234,32601532,Repair bond strength of resin composite to three aged CAD/CAM blocks using different repair systems.,"PURPOSE The purpose of this study is to evaluate the repair bond strength of a nanohybrid resin composite to three CAD/CAM blocks using different intraoral ceramic repair systems. MATERIALS AND METHODS Three CAD/CAM blocks (Lava Ultimate, Cerasmart, and Vitablocks Mark II) were selected for the study. Thirty-two specimens were fabricated from each block. Specimens were randomly divided into eight groups for the following different intraoral repair systems: Group 1: control group (no treatment); Group 2: 34.5% phosphoric acid etching; Group 3: CoJet System; Group 4: Z-Prime Plus System; Group 5: GC Repair System; Group 6: Cimara System; Group 7: Porcelain Repair System; and Group 8: Clearfil Repair System. Then, nanohybrid resin composite (Tetric Evo Ceram) was packed onto treated blocks surfaces. The specimens were thermocycled before application of repair systems and after application of composite resin. After second thermal cycling, blocks were cut into bars (1 × 1 × 12 mm 3 ) for microtensile bond strength tests. Data were analyzed using two-way ANOVA and Tukey's HSD test (α=.05). RESULTS Cimara System, Porcelain Repair, and Clearfil Repair systems significantly increased the bond strength of nanohybrid resin composite to all CAD/CAM blocks when compared with the other tested repair systems ( P <.05). In terms of CAD/CAM blocks, the lowest values were observed in Vitablocks Mark II groups ( P <.05). CONCLUSION All repair systems used in the study exhibited clinically acceptable bond strength and can be recommended for clinical use.",2020,"Cimara System, Porcelain Repair, and Clearfil Repair systems significantly increased the bond strength of nanohybrid resin composite to all CAD/CAM blocks when compared with the other tested repair systems ( P <.05).","['Three CAD/CAM blocks (Lava Ultimate, Cerasmart, and Vitablocks Mark II) were selected for the study']",['control group (no treatment); Group 2: 34.5% phosphoric acid etching; Group 3: CoJet System; Group 4: Z-Prime Plus System; Group 5: GC Repair System; Group 6: Cimara System; Group 7: Porcelain Repair System; and Group 8: Clearfil Repair System'],['bond strength of nanohybrid resin composite'],"[{'cui': 'C0011905', 'cui_str': 'Computer-Assisted Diagnosis'}, {'cui': 'C0002346', 'cui_str': 'Medicine, Alternative'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0218457', 'cui_str': 'Vita Mark II'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0031700', 'cui_str': 'Phosphoric acid'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0441876', 'cui_str': 'Group 4'}, {'cui': 'C4308556', 'cui_str': 'Z-Prime Plus'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0011392', 'cui_str': 'Dental porcelain material'}, {'cui': 'C1433267', 'cui_str': 'Clearfil repair'}]","[{'cui': 'C0028758', 'cui_str': 'Bonding (Psychology)'}, {'cui': 'C0009570', 'cui_str': 'Composite Resins'}]",32.0,0.0193149,"Cimara System, Porcelain Repair, and Clearfil Repair systems significantly increased the bond strength of nanohybrid resin composite to all CAD/CAM blocks when compared with the other tested repair systems ( P <.05).","[{'ForeName': 'Pinar', 'Initials': 'P', 'LastName': 'Gul', 'Affiliation': 'Department of Restorative Dentistry, Faculty of Dentistry, Atatürk University, Erzurum, Turkey.'}, {'ForeName': 'Latife', 'Initials': 'L', 'LastName': 'Altınok-Uygun', 'Affiliation': 'Graduate Department of Restorative Dentistry, Faculty of Dentistry, Atatürk University, Erzurum, Turkey.'}]",The journal of advanced prosthodontics,['10.4047/jap.2020.12.3.131'] 2235,32601560,Comparison of Radial Extracorporeal Shock Wave Therapy in Plantar Fasciitis Treatment Using Two Different Frequencies.,"Objective To compare results of two different frequencies and densities of radial extracorporeal shock wave therapy (rESWT) after 10 sessions. Methods A total of 41 patients with plantar fasciitis were included in this study. Patients were randomly divided into two groups. Both groups were administered 10 sessions of treatment consisting of 15 Hz frequency, 3.0 Bar density and 2000 impulses/ session for the 1 st group, and 10 Hz frequency, 2.0 Bar density and 2000 impulses/ session for the 2 nd group. Visual analog scale (VAS) and a modification of the clinical rating system of the American Orthopedic Foot and Ankle Society (AOFAS) were used for outcome measurement. The patients were assessed before treatment and followed up four weeks, and 12 weeks after end of treatment. Results Mean VAS scores were reduced after rESWT from 7.52 ± 2.34 (mean ± SEM) at baseline to 0.57 ± 0.68 at 12 weeks in the 1 st group and from 6.45 ± 2.04 at baseline to 0.40 ± 0.60 at 12 weeks in the 2 nd group. Similar changes were found for mean AOFAS scores from baseline after rESWT but were not observed significance between groups. Conclusion There is no significant different effect between the two treatment groups' results.",2020,Results Mean VAS scores were reduced after rESWT from 7.52 ± 2.34 (mean ± SEM) at baseline to 0.57 ± 0.68 at 12 weeks in the 1 st group and from 6.45 ± 2.04 at baseline to 0.40 ± 0.60 at 12 weeks in the 2 nd group.,"['Plantar Fasciitis Treatment Using Two Different Frequencies', '41 patients with plantar fasciitis']","['American Orthopedic Foot and Ankle Society (AOFAS', 'radial extracorporeal shock wave therapy (rESWT', 'Radial Extracorporeal Shock Wave Therapy']","['mean AOFAS scores', 'Visual analog scale (VAS', 'Mean VAS scores']","[{'cui': 'C0149756', 'cui_str': 'Plantar fasciitis'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0442038', 'cui_str': 'Radial'}, {'cui': 'C1737238', 'cui_str': 'Extracorporeal shock wave therapy'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]",41.0,0.0331842,Results Mean VAS scores were reduced after rESWT from 7.52 ± 2.34 (mean ± SEM) at baseline to 0.57 ± 0.68 at 12 weeks in the 1 st group and from 6.45 ± 2.04 at baseline to 0.40 ± 0.60 at 12 weeks in the 2 nd group.,"[{'ForeName': 'Selnur', 'Initials': 'S', 'LastName': 'Narin', 'Affiliation': 'Physiotherapy and Rehabilitation, Institute of Health, Dokuz Eylul University, Izmir, TUR.'}, {'ForeName': 'Bayram', 'Initials': 'B', 'LastName': 'Unver', 'Affiliation': 'School of Physical Therapy and Rehabilitation, Dokuz Eylul University, Izmir, TUR.'}, {'ForeName': 'Nihat Demirhan', 'Initials': 'ND', 'LastName': 'Demirkıran', 'Affiliation': 'Orthopaedics, Kütahya Health Sciences University School of Medicine, Kütahya, TUR.'}, {'ForeName': 'Mehmet', 'Initials': 'M', 'LastName': 'Erduran', 'Affiliation': 'Orthopaedics and Traumatology, Dokuz Eylul University, Izmir, TUR.'}]",Cureus,['10.7759/cureus.8284'] 2236,32597041,Comparison of Postextubation Outcomes Associated with High-Flow Nasal Cannula vs. Conventional Oxygen Therapy in Patients at High Risk of Reintubation: a Randomized Clinical Trial.,"BACKGROUND Liberation and extubation are important for patients supported by mechanical ventilation. Extubation success is related to the duration of an intensive care unit (ICU) stay and mortality rate. High-flow nasal cannula (HFNC) oxygen therapy has physiological and clinical benefits in respiratory care. The present study compared clinical outcomes associated with HFNC and conventional oxygen therapy (COT) among patients at high risk for reintubation. METHODS A single-center randomized clinical trial was conducted between March 2018 and June 2019. Sixty adults admitted to the ICU and who were at high-risk of reintubation and met the inclusion criteria were enrolled in this study. ""High risk"" for reintubation was defined as having at least one of the following risk factors: age > 65 years, Acute Physiology and Chronic Health Evaluation II score > 12 points on extubation day, obesity, poor expectoration, airway patency problems, difficult or prolonged weaning, and more than one comorbidity. The primary outcome of interest was reintubation within 72 hours. Secondary outcomes included duration of ICU and hospital stay, mortality rate, and time to reintubation. RESULTS Of 60 patients, 31 received HFNC and 29 received COT (mean age, 78 ± 7.8 vs. 76 ± 6.5 years, respectively). Reintubation rate within 72 hours did not differ between the groups (3 patients [9.7%] vs. 1 patient [3.4%], respectively). Reintubation time was shorter among patients who received COT than among patients who received HFNC (0.5 hour vs. 25 hours), but this difference was not statistically significant. Duration of ICU did not differ between the groups (14.7 ± 9.6 days vs. 13.8 ± 15.7 days, for HFNC and COT, respectively). CONCLUSION Among patients at high risk for reintubation, compared with COT, HFNC did not reduce the risk of reintubation within 72 hours.",2020,"Reintubation time was shorter among patients who received COT than among patients who received HFNC (0.5 hour vs. 25 hours), but this difference was not statistically significant.","['Of 60 patients, 31 received HFNC and 29 received COT (mean age, 78 ± 7.8 vs. 76 ± 6.5 years, respectively', 'patients at high risk for reintubation', 'Patients at High Risk of Reintubation', 'A single-center randomized clinical trial was conducted between March 2018 and June 2019', 'Sixty adults admitted to the ICU and who were at high-risk of reintubation and met the inclusion criteria were enrolled in this study. ']","['COT', 'HFNC and conventional oxygen therapy (COT', 'High-flow nasal cannula (HFNC) oxygen therapy', 'COT, HFNC', 'High-Flow Nasal Cannula vs. Conventional Oxygen Therapy', 'HFNC']","['Reintubation rate', 'duration of an intensive care unit (ICU) stay and mortality rate', 'Extubation success', 'Postextubation Outcomes', 'Reintubation time', 'Duration of ICU', 'duration of ICU and hospital stay, mortality rate, and time to reintubation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0179574', 'cui_str': 'Nasal Cannulae'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0184633', 'cui_str': 'Oxygen therapy'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3844007', 'cui_str': '6.5'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0860359', 'cui_str': 'Reintubate'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0184633', 'cui_str': 'Oxygen therapy'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0179574', 'cui_str': 'Nasal Cannulae'}]","[{'cui': 'C0860359', 'cui_str': 'Reintubate'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0553891', 'cui_str': 'Extubation of trachea'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}]",60.0,0.17062,"Reintubation time was shorter among patients who received COT than among patients who received HFNC (0.5 hour vs. 25 hours), but this difference was not statistically significant.","[{'ForeName': 'Jun Yeun', 'Initials': 'JY', 'LastName': 'Cho', 'Affiliation': 'Department of Internal Medicine, Chungbuk National University Hospital, Chungbuk National University College of Medicine, Cheongju, Korea.'}, {'ForeName': 'Hee Sung', 'Initials': 'HS', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Chungbuk National University Hospital, Chungbuk National University College of Medicine, Cheongju, Korea.'}, {'ForeName': 'Hyeran', 'Initials': 'H', 'LastName': 'Kang', 'Affiliation': 'Department of Internal Medicine, Chungbuk National University Hospital, Chungbuk National University College of Medicine, Cheongju, Korea.'}, {'ForeName': 'Sun Hyung', 'Initials': 'SH', 'LastName': 'Kim', 'Affiliation': 'Department of Internal Medicine, Chungbuk National University Hospital, Chungbuk National University College of Medicine, Cheongju, Korea.'}, {'ForeName': 'Kang Hyeon', 'Initials': 'KH', 'LastName': 'Choe', 'Affiliation': 'Department of Internal Medicine, Chungbuk National University Hospital, Chungbuk National University College of Medicine, Cheongju, Korea.'}, {'ForeName': 'Ki Man', 'Initials': 'KM', 'LastName': 'Lee', 'Affiliation': 'Department of Internal Medicine, Chungbuk National University Hospital, Chungbuk National University College of Medicine, Cheongju, Korea.'}, {'ForeName': 'Yoon Mi', 'Initials': 'YM', 'LastName': 'Shin', 'Affiliation': 'Department of Internal Medicine, Chungbuk National University Hospital, Chungbuk National University College of Medicine, Cheongju, Korea. anees94@hanmail.net.'}]",Journal of Korean medical science,['10.3346/jkms.2020.35.e194'] 2237,32597119,Short term effects of home-based bladder training and pelvic floor muscle training in symptoms of urinary incontinence.,"AIM The aim of this non-controlled trial was to investigate the effects of a homebased pelvic floor muscle training (PFMT) and bladder training (BT) in urinary incontinence (UI) among women. PATIENTS AND METHODS The study included 25 individuals who were diagnosed with UI. PFMT which strengthens pelvic floor muscles was described to patients in litotomy position with using digital palpation method. PFMT was given as homebased exercise program for six weeks, 7 days a week and ten times a day. BT was planned according to the symptoms of the patients. Assessments were done at the beginning and at the end of the six weeks exercise program. The outcome measures were UI severity measured by pad test and QoL measured by King's Health Questionnaire. The secondary outcome measure was lower urinary tract symptoms and sexual health measured by Bristol Female Lower Urinary Tract Symptoms Index. RESULTS Pre- and post-treatment assessments done with pad test showed that there was a statistically significant decrease in the severity of UI (p = 0.002). The difference between preand post-treatment QoL scores (p = 0.001) and lower tract symptom scores were also statistically significant (p = 0.000). CONCLUSIONS When PFMT and BT were given together there was a decrease in the symptoms and increases the QoL.",2020,"The difference between preand post-treatment QoL scores (p = 0.001) and lower tract symptom scores were also statistically significant (p = 0.000). ","['25 individuals who were diagnosed with UI', 'urinary incontinence (UI) among women']","['homebased pelvic floor muscle training (PFMT) and bladder training (BT', 'PFMT', 'home-based bladder training and pelvic floor muscle training', 'BT']","['lower urinary tract symptoms and sexual health measured by Bristol Female Lower Urinary Tract Symptoms Index', 'lower tract symptom scores', ""UI severity measured by pad test and QoL measured by King's Health Questionnaire"", 'severity of UI']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0042024', 'cui_str': 'Urinary incontinence'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C4087139', 'cui_str': 'Pelvic floor muscle training'}, {'cui': 'C0150474', 'cui_str': 'Urinary bladder training'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0574785', 'cui_str': 'Lower urinary tract symptoms'}, {'cui': 'C2362326', 'cui_str': 'Sexual Health'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0042024', 'cui_str': 'Urinary incontinence'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0332568', 'cui_str': 'Pad'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",25.0,0.0507947,"The difference between preand post-treatment QoL scores (p = 0.001) and lower tract symptom scores were also statistically significant (p = 0.000). ","[{'ForeName': 'Aybuke', 'Initials': 'A', 'LastName': 'Ersin', 'Affiliation': 'Istanbul Medipol University, Institute of Health Sciences, Department of Physiotherapy and Rehabilitation, Istanbul. aybukeu2011@gmail.com.'}, {'ForeName': 'Sule B', 'Initials': 'SB', 'LastName': 'Demirbas', 'Affiliation': ''}, {'ForeName': 'Fatih', 'Initials': 'F', 'LastName': 'Tarhan', 'Affiliation': ''}]","Archivio italiano di urologia, andrologia : organo ufficiale [di] Societa italiana di ecografia urologica e nefrologica",['10.4081/aiua.2020.2.142'] 2238,32597122,"Comparison of the efficiency, safety and pain scores of holmium laser devices working with 20 watt and 30 watt using in retrograde intrarenal surgery: One center prospective study.","OBJECTIVES Holmium:Yttrium Aluminum Garnet laser lithotripsy is used in Retrograde Intrarenal Surgery. Fragmentation is made with a certain value of pulse energy (Joule) and frequency (Hertz) in Holmium laser lithotripsy and the multiplication of these values gives us total power (Watt). Devices with maximum power of 20 Watt and 30 Watt are used in clinical practice. We want to compare the efficiency, safety and pain scores of the lithotripsy made below 20 Watt and over 30 Watt with 30 Watt laser device. MATERIALS AND METHODS 60 patients who had 2-3 cm sized kidney stones and operation planned were prospectively divided into three groups. Groups were random identified. In the first group, fragmentation was performed below 20 Watt power with 20 Watt laser device. In the second group, fragmentation was performed below 20 Watt power with 30 Watt laser device. In the third group, fragmentation was performed over 20 Watt power with 30 Watt laser device. Demographic, stone, intraoperative and postoperative data were recorded. We compared these groups regarding efficiency, safety and pain score. RESULTS For demographic and stone data, there was a statistically significant difference only for stone number. For intraoperative and postoperative data, there was a statistically significant difference only for ureteral access sheath usage between the groups. Success was lower than the other groups in Group 1. CONCLUSIONS Success was higher in groups using 30 Watt laser device. There was not statistically significantly difference between complications and pain. 30 Watt laser device is safe and efficient in Retrograde Intrarenal Surgery.",2020,There was not statistically significantly difference between complications and pain.,['60 patients who had 2-3 cm sized kidney stones and operation planned'],"['30 Watt laser device', 'holmium laser devices working with 20 watt and 30 watt using in retrograde intrarenal surgery', 'Holmium:Yttrium Aluminum Garnet laser lithotripsy', 'Holmium laser lithotripsy']","['Success', 'stone number', 'efficiency, safety and pain score', 'complications and pain', 'Demographic, stone, intraoperative and postoperative data', 'efficiency, safety and pain scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022650', 'cui_str': 'Kidney stone'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}]","[{'cui': 'C0439261', 'cui_str': 'watt'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0441085', 'cui_str': 'Holmium:YAG laser device'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0439784', 'cui_str': 'Retrograde direction'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0019846', 'cui_str': 'Holmium'}, {'cui': 'C0587723', 'cui_str': 'YAG - laser'}, {'cui': 'C0023878', 'cui_str': 'Lithotripsy'}]","[{'cui': 'C0006736', 'cui_str': 'Calculus'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}]",60.0,0.0217963,There was not statistically significantly difference between complications and pain.,"[{'ForeName': 'Sercan', 'Initials': 'S', 'LastName': 'Sari', 'Affiliation': 'Bozok University, Department of Urology,Yozgat. sercansari92@hotmail.com.'}, {'ForeName': 'Mehmet Çaglar', 'Initials': 'MÇ', 'LastName': 'Çakici', 'Affiliation': ''}, {'ForeName': 'Ibrahim Güven', 'Initials': 'IG', 'LastName': 'Kartal', 'Affiliation': ''}, {'ForeName': 'Volkan', 'Initials': 'V', 'LastName': 'Selmï', 'Affiliation': ''}, {'ForeName': 'Harun', 'Initials': 'H', 'LastName': 'Özdemïr', 'Affiliation': ''}, {'ForeName': 'Hakkı Ugur', 'Initials': 'HU', 'LastName': 'Ozok', 'Affiliation': ''}, {'ForeName': 'Ahmet Nihat', 'Initials': 'AN', 'LastName': 'Karakoyunlu', 'Affiliation': ''}, {'ForeName': 'Serkan', 'Initials': 'S', 'LastName': 'Yildiz', 'Affiliation': ''}, {'ForeName': 'Emre', 'Initials': 'E', 'LastName': 'Hepsen', 'Affiliation': ''}, {'ForeName': 'Serra', 'Initials': 'S', 'LastName': 'Ozbal', 'Affiliation': ''}, {'ForeName': 'Hamit', 'Initials': 'H', 'LastName': 'Ersoy', 'Affiliation': ''}]","Archivio italiano di urologia, andrologia : organo ufficiale [di] Societa italiana di ecografia urologica e nefrologica",['10.4081/aiua.2020.2.149'] 2239,32597287,Immediate effects of plantar vibration stimuli during static upright posture following total hip arthroplasty in females.,"Purpose: Proprioceptive function of the lower limbs deteriorates in patients following total hip arthroplasty. Patients show poor balance and rely more on visual information than proprioceptive information. Plantar vibration stimuli can mechanically enhance somatosensory input from the plantar cutaneous mechanoreceptors, thereby improving static balance. Plantar vibration stimuli may improve static balance in patients after total hip arthroplasty. This is the first study to investigate whether plantar vibration stimuli affects static balance during the early phase following total hip arthroplasty. Materials and methods: In this cross-over design study, 16 female patients (aged 65.1 ± 11.0 years) received plantar vibration stimuli for 2 minutes or the sham interventions after total hip arthroplasty in a randomized order on different days. The foot centre of pressure was measured for the total path length, mediolateral path length, and anteroposterior path length directions before and immediately after the interventions in the static standing position both with eyes open and closed. Patients were instructed to minimize body sway when standing. Results: A significant increase was observed in the centre of pressure parameters in the eyes closed condition than in the eyes open condition. The centre of pressure parameters for the eyes closed condition was significantly decreased after vibration interventions than that before intervention. Conclusions: This study supports the view that plantar vibration stimuli can change static balance in patients in the early phase after total hip arthroplasty temporarily by up-weighting sensory information. These stimuli may serve as a treatment option for influencing balance following total hip arthroplasty.",2020,The centre of pressure parameters for the eyes closed condition was significantly decreased after vibration interventions than that before intervention.,"['total hip arthroplasty in females', '16 female patients (aged 65.1\u2009±\u200911.0\u2009years) received', 'patients after total hip arthroplasty', 'patients following total hip arthroplasty', 'patients in the early phase after total hip arthroplasty temporarily by up-weighting sensory information', 'total hip arthroplasty']","['plantar vibration stimuli during static upright posture', 'plantar vibration stimuli for 2\u2009minutes or the sham interventions after total hip arthroplasty', 'Plantar vibration stimuli', 'plantar vibration stimuli']","['centre of pressure parameters', 'static balance', 'total path length, mediolateral path length, and anteroposterior path length directions']","[{'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}]","[{'cui': 'C0230463', 'cui_str': 'Structure of sole of foot'}, {'cui': 'C0455941', 'cui_str': 'Vibration - treatment'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0872410', 'cui_str': 'Posturing'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}]","[{'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0441992', 'cui_str': 'Mediolateral'}, {'cui': 'C0439755', 'cui_str': 'Directions'}]",16.0,0.0128333,The centre of pressure parameters for the eyes closed condition was significantly decreased after vibration interventions than that before intervention.,"[{'ForeName': 'Kosuke', 'Initials': 'K', 'LastName': 'Oku', 'Affiliation': 'Nara Medical University Graduate School, Kashihara, Nara, Japan.'}, {'ForeName': 'Isao', 'Initials': 'I', 'LastName': 'Kawahara', 'Affiliation': 'Division of Rehabilitation, Hanna Central Hospital, Ikoma, Nara, Japan.'}, {'ForeName': 'Tatsuya', 'Initials': 'T', 'LastName': 'Sugioka', 'Affiliation': 'Division of Rehabilitation, Hanna Central Hospital, Ikoma, Nara, Japan.'}, {'ForeName': 'Yasuhito', 'Initials': 'Y', 'LastName': 'Tanaka', 'Affiliation': 'Department of Orthopaedic Surgery, Nara Medical University, Kashihara, Nara, Japan.'}, {'ForeName': 'Takuma', 'Initials': 'T', 'LastName': 'Hoshiba', 'Affiliation': 'Faculty of Sport Sciences, Waseda University, Tokorozawa, Saitama, Japan.'}, {'ForeName': 'Norikazu', 'Initials': 'N', 'LastName': 'Hirose', 'Affiliation': 'Faculty of Sport Sciences, Waseda University, Tokorozawa, Saitama, Japan.'}, {'ForeName': 'Tsukasa', 'Initials': 'T', 'LastName': 'Kumai', 'Affiliation': 'Faculty of Sport Sciences, Waseda University, Tokorozawa, Saitama, Japan.'}]",Somatosensory & motor research,['10.1080/08990220.2020.1784129'] 2240,32597373,Testing the Effectiveness of a Strengths-Based Intervention Targeting All 24 Strengths: Results From a Randomized Controlled Trial.,"This study assessed the effectiveness of a strengths-based randomized controlled trial focused on fostering all 24 character strengths in a group of 75 participants from a University in Tunisia. Participants randomly assigned to the challenge condition (n = 40) received an email each day for 24 days, that highlighted a particular strength of the day including why the strength is valuable, how to implement the strength behaviourally, and a motto related to that strength. Those in the control condition (n = 35) simply received emails containing the motto for each strength daily for 24 days. We assessed all participants' levels of happiness before the experiment (T0), the day following the experiment (T1), and one-month following the experiment (T2). Results from a 2 (group) X 3 (time) split plot ANOVA revealed a significant group-by-time interaction, such that at T2 the experimental group had greater happiness scores than the control group. These findings provide some evidence that even ""minimalist"" interventions (involving the receipt of emails encouraging character-strength development), might be effective for promoting gains in happiness even one month after the intervention.",2020,"We assessed all participants' levels of happiness before the experiment (T0), the day following the experiment (T1), and one-month following the experiment (T2).",['fostering all 24 character strengths in a group of 75 participants from a University in Tunisia'],[],['happiness scores'],"[{'cui': 'C0242298', 'cui_str': 'Fostering'}, {'cui': 'C0007952', 'cui_str': 'Character'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0041388', 'cui_str': 'Tunisia'}]",[],"[{'cui': 'C0018592', 'cui_str': 'Cheerful mood'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",75.0,0.0324202,"We assessed all participants' levels of happiness before the experiment (T0), the day following the experiment (T1), and one-month following the experiment (T2).","[{'ForeName': 'Lobna', 'Initials': 'L', 'LastName': 'Chérif', 'Affiliation': 'Royal Military College of Canada, Kingston, Ontario, Canada.'}, {'ForeName': 'Valerie M', 'Initials': 'VM', 'LastName': 'Wood', 'Affiliation': ""Queen's University, Kingston, Ontario, Canada.""}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Watier', 'Affiliation': 'Lanla Mesure\u2009+\u2009Gestion, Montreal, Québec, Canada.'}]",Psychological reports,['10.1177/0033294120937441'] 2241,32597390,Virtual reality assisted conscious sedation during transcatheter aortic valve implantation - a randomized pilot study.,"AIMS Virtual Reality (VR) has been used successfully in different clinical settings to treat anxiety. This prospective, randomized pilot study investigates the feasibility and safety of VR in patients undergoing conscious sedation during transfemoral transcatheter aortic valve implantation (TAVI). METHODS AND RESULTS Thirty-two patients were included and randomized to VR intervention (n=16) or control (n=16). In the intervention group, patient-selected relaxing 3D-Videos were projected during the TAVI procedure; pain and anxiety before and after TAVI were measured using visual analog scales (VAS, 0-10). The median age was 83 years (IQR 78.25-87). Patients' baseline characteristics did not differ significantly between groups. During TAVI under conscious sedation, the median duration of VR intervention was 30.5 minutes (IQR 23.5-46). 81.3% of the patients watched the videos until device implantation, 37.5% during the whole procedure. The VR-intervention group reported significantly less anxiety after the procedure (VAS 2 (IQR 0-3.75) vs. 5 (IQR 2-8), p=0.04) than patients randomized to control. 93.8% of the intervention group would use VR during TAVI again. Nausea and vomiting did not occur more frequently compared to control. CONCLUSIONS VR-interventions during TAVI to assist conscious sedation are safe and feasible, even in very old and frail patients. In this small cohort, there was a significant reduction in anxiety.",2020,"The VR-intervention group reported significantly less anxiety after the procedure (VAS 2 (IQR 0-3.75) vs. 5 (IQR 2-8), p=0.04) than patients randomized to control.","['very old and frail patients', 'Thirty-two patients', 'n=16) or control (n=16', 'patients undergoing conscious sedation during transfemoral transcatheter aortic valve implantation (TAVI']","['Virtual Reality (VR', 'VR', 'transcatheter aortic valve implantation', 'Virtual reality assisted conscious sedation', 'VR intervention']","['Nausea and vomiting', 'anxiety', 'median duration of VR intervention']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0079377', 'cui_str': 'Frail elderly'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0450357', 'cui_str': '32'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0079159', 'cui_str': 'Conscious sedation'}, {'cui': 'C2711836', 'cui_str': 'Percutaneous replacement of aortic valve using fluoroscopic guidance'}]","[{'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C2711836', 'cui_str': 'Percutaneous replacement of aortic valve using fluoroscopic guidance'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0079159', 'cui_str': 'Conscious sedation'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0027498', 'cui_str': 'Nausea and vomiting'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",32.0,0.0306396,"The VR-intervention group reported significantly less anxiety after the procedure (VAS 2 (IQR 0-3.75) vs. 5 (IQR 2-8), p=0.04) than patients randomized to control.","[{'ForeName': 'Raphael Romano', 'Initials': 'RR', 'LastName': 'Bruno', 'Affiliation': 'Division of Cardiology, Pulmonology, and Vascular Medicine, Medical Faculty, University Hospital Düsseldorf, Düsseldorf, Germany.'}, {'ForeName': 'Yingfeng', 'Initials': 'Y', 'LastName': 'Lin', 'Affiliation': ''}, {'ForeName': 'Georg', 'Initials': 'G', 'LastName': 'Wolff', 'Affiliation': ''}, {'ForeName': 'Amin', 'Initials': 'A', 'LastName': 'Polzin', 'Affiliation': ''}, {'ForeName': 'Verena', 'Initials': 'V', 'LastName': 'Veulemans', 'Affiliation': ''}, {'ForeName': 'Kathrin', 'Initials': 'K', 'LastName': 'Klein', 'Affiliation': ''}, {'ForeName': 'Ralf', 'Initials': 'R', 'LastName': 'Westenfeld', 'Affiliation': ''}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Zeus', 'Affiliation': ''}, {'ForeName': 'Malte', 'Initials': 'M', 'LastName': 'Kelm', 'Affiliation': ''}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Jung', 'Affiliation': ''}]",EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology,['10.4244/EIJ-D-20-00269'] 2242,32597580,"[Efficiency and safety of phenazopyridine for treatment of uncomplicated urinary tract infection: results of multi-center, randomized, placebo-controlled, clinical study].","AIM to evaluate the efficiency and safety of phenazopyridine for the treatment of patients with uncomplicated lower urinary tract infection, accompanied by pain. MATERIALS AND METHODS A multicenter double-blind, randomized, placebo-controlled study with parallel groups to evaluate the efficacy and safety of phenazopyridine in patients with acute uncomplicated cystitis was performed. A total of 60 women were divided into two groups of 30 patients. In the main group (average age 32.6+/-7.4 years) phenazopyridine was prescribed (2 tablets of 100 mg p.o., with a total dose of 200 mg, once). In the control group, patients (mean age 35.53+/-8.79 years) received a placebo according to the same scheme. To evaluate the efficiency of treatment, the severity of the main symptoms 6 hours after taking the drug was analyzed. After that, patients started antibiotic therapy. They were followed-up for the next three days. The tolerance of therapy was evaluated by the presence of adverse events. RESULTS All 30 patients taking phenazopyridine had an improvement after 6 hours, and the most frequent response was ""significant improvement"" (43.3%). The responses of patients in the main group significantly (p<0.05) differed from responses of patients in the control group. Six hours after taking phenazopyridine/placebo, the severity of all values according to VAS score, including the degree of general discomfort, pain during urination and increased frequency of urination improved significantly in the main group compared to the control group. The average assessment of general discomfort in the main group decreased by 53.4% in comparison with 28.8% in the control group, while the severity of pain during urination and urination frequency decreased by 57.4 vs. 35.9% and 39.6 vs. 27.6%, respectively. An analysis of the time before the complete absence of the general discomfort was performed. In the main group this period of time was significantly less than in the control group (p<0.05). There were no serious adverse events while taking phenazopyridine. Rate of adverse events was comparable between two groups. CONCLUSION The results of the study showed that phenazopyridine is an effective and well-tolerated drug for symptomatic therapy in patients with acute uncomplicated cystitis and can be recommended in addition to etiological therapy.",2020,In the main group this period of time was significantly less than in the control group (p<0.05).,"['patients with acute uncomplicated cystitis', 'patients with uncomplicated lower urinary tract infection, accompanied by pain', 'A total of 60 women were divided into two groups of 30 patients', 'uncomplicated urinary tract infection']","['phenazopyridine/placebo', 'phenazopyridine', 'placebo']","['VAS score', 'degree of general discomfort, pain during urination and increased frequency of urination', 'efficiency and safety', 'efficacy and safety', 'Rate of adverse events', 'average assessment of general discomfort', 'severity of pain during urination and urination frequency']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0443334', 'cui_str': 'Uncomplicated'}, {'cui': 'C0010692', 'cui_str': 'Cystitis'}, {'cui': 'C0268821', 'cui_str': 'Lower urinary tract infectious disease'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease'}]","[{'cui': 'C0031379', 'cui_str': 'Phenazopyridine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0858924', 'cui_str': 'General discomfort'}, {'cui': 'C0013428', 'cui_str': 'Dysuria'}, {'cui': 'C0042023', 'cui_str': 'Increased frequency of urination'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",60.0,0.0541587,In the main group this period of time was significantly less than in the control group (p<0.05).,"[{'ForeName': 'S B', 'Initials': 'SB', 'LastName': 'Petrov', 'Affiliation': 'Scientific and Research Center of Urology in Scientific and Research Institute for Surgery and Emergency Medicine of Pavlov First Saint Petersburg State Medical University of the Ministry of Health of Russia, Saint Petersburg, Russia.'}, {'ForeName': 'M N', 'Initials': 'MN', 'LastName': 'Slesarevskaya', 'Affiliation': 'Scientific and Research Center of Urology in Scientific and Research Institute for Surgery and Emergency Medicine of Pavlov First Saint Petersburg State Medical University of the Ministry of Health of Russia, Saint Petersburg, Russia.'}, {'ForeName': 'K H', 'Initials': 'KH', 'LastName': 'Chibirov', 'Affiliation': 'Scientific and Research Center of Urology in Scientific and Research Institute for Surgery and Emergency Medicine of Pavlov First Saint Petersburg State Medical University of the Ministry of Health of Russia, Saint Petersburg, Russia.'}, {'ForeName': 'M E', 'Initials': 'ME', 'LastName': 'Topuzov', 'Affiliation': 'Scientific and Research Center of Urology in Scientific and Research Institute for Surgery and Emergency Medicine of Pavlov First Saint Petersburg State Medical University of the Ministry of Health of Russia, Saint Petersburg, Russia.'}, {'ForeName': 'O F', 'Initials': 'OF', 'LastName': 'Kagan', 'Affiliation': 'Scientific and Research Center of Urology in Scientific and Research Institute for Surgery and Emergency Medicine of Pavlov First Saint Petersburg State Medical University of the Ministry of Health of Russia, Saint Petersburg, Russia.'}, {'ForeName': 'E N', 'Initials': 'EN', 'LastName': 'Voronova', 'Affiliation': 'Scientific and Research Center of Urology in Scientific and Research Institute for Surgery and Emergency Medicine of Pavlov First Saint Petersburg State Medical University of the Ministry of Health of Russia, Saint Petersburg, Russia.'}]","Urologiia (Moscow, Russia : 1999)",[] 2243,32597582,[Prevention of infectious and inflammatory complications after percutaneous nephrolithotomy].,"INTRODUCTION Given the increase in antibiotic resistance of uropathogens, one of the urgent problems is a development of optimal antimicrobial prophylaxis for surgical interventions, as well as an adequate regimen of antibiotic therapy after percutaneous nephrolithotomy (PCNL). AIM to determine an effective perioperative antimicrobial prophylaxis for PCNL in patients with kidney stones. MATERIAL AND METHODS A total of 90 patients with staghorn or multiple large kidney stones who underwent PCNL were included in the study. Before PCNL, urine culture was performed in all patients in order to determine the sensitivity not only to antibiotics, but also to bacteriophages. In addition, urine was taken for additional microbiological studies after the puncture of the collecting system, as well as on the 3rd and 7th day after PCNL. All patients were divided into three groups of 30 patients depending on the regimen of perioperative prophylaxis. In group 1, patients were prescribed ciprofloxacin 1000 mg i.v. intraoperatively, then 1000 mg i.v. q.d. for 3-5 days. In the group 2, patients received one dose of cefotaxime + sulbactam (1.0 g + 0.5 g) 2 hours before PCNL i.m. In the group 3, a polyvalent pyobacteriophage purified was given orally 1 hour before PCNL in a dose of 40 ml and the same dose was used t.i.d. for 3-5 days postoperatively. RESULTS In all three groups of patients, the following infectious complications were evaluated: acute pyelonephritis, systemic inflammatory response syndrome (SIRS) and urosepsis. There were no serious infectious and inflammatory complications in the early postoperative period among all patients. SIRS developed on days 1-3 after PCNL in 26.6%, 20% and 20% of patients in group 1, 2 and 3, respectively. However, by days 4-7 after PCNL, there was normalization of blood cells count (leukocytes, neutrophil band cells), temperature and general condition. CONCLUSION Different regimens of antimicrobial prophylaxis for PCNL have the same efficiency. The development of SIRS on days 1-3 after PCNL is correlated not only with the antimicrobial agents used and the route of their administration (intravenously, intramuscularly and orally). Most likely, the development of SIRS is more associated with surgical trauma.",2020,There were no serious infectious and inflammatory complications in the early postoperative period among all patients.,"['90 patients with staghorn or multiple large kidney stones who underwent PCNL were included in the study', 'patients with kidney stones']","['cefotaxime + sulbactam', 'percutaneous nephrolithotomy', 'ciprofloxacin', 'perioperative prophylaxis']","['normalization of blood cells count (leukocytes, neutrophil band cells), temperature and general condition', 'acute pyelonephritis, systemic inflammatory response syndrome (SIRS) and urosepsis', 'SIRS', 'serious infectious and inflammatory complications']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332249', 'cui_str': 'Staghorn'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0542518', 'cui_str': 'Large kidney'}, {'cui': 'C0006736', 'cui_str': 'Calculus'}, {'cui': 'C0162428', 'cui_str': 'Removal of calculus of renal pelvis through percutaneous nephrostomy'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0022650', 'cui_str': 'Kidney stone'}]","[{'cui': 'C0007554', 'cui_str': 'Cefotaxime'}, {'cui': 'C0038665', 'cui_str': 'Sulbactam'}, {'cui': 'C0162428', 'cui_str': 'Removal of calculus of renal pelvis through percutaneous nephrostomy'}, {'cui': 'C0008809', 'cui_str': 'Ciprofloxacin'}, {'cui': 'C0033107', 'cui_str': 'prevention & control'}]","[{'cui': 'C0005771', 'cui_str': 'Blood cell count'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C3661517', 'cui_str': 'Band neutrophil'}, {'cui': 'C0005903', 'cui_str': 'Body temperature'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0520575', 'cui_str': 'Acute pyelonephritis'}, {'cui': 'C0242966', 'cui_str': 'Systemic inflammatory response syndrome'}, {'cui': 'C0149801', 'cui_str': 'Sepsis due to urinary tract infection'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",90.0,0.0553742,There were no serious infectious and inflammatory complications in the early postoperative period among all patients.,"[{'ForeName': 'T S', 'Initials': 'TS', 'LastName': 'Perepanova', 'Affiliation': 'N.A. Lopatkin Research Institute of Urology and Interventional Radiology branch of the National Medical Research Radiological Center, Moscow, Russia.'}, {'ForeName': 'D S', 'Initials': 'DS', 'LastName': 'Merinov', 'Affiliation': 'N.A. Lopatkin Research Institute of Urology and Interventional Radiology branch of the National Medical Research Radiological Center, Moscow, Russia.'}, {'ForeName': 'A V', 'Initials': 'AV', 'LastName': 'Kazachenko', 'Affiliation': 'N.A. Lopatkin Research Institute of Urology and Interventional Radiology branch of the National Medical Research Radiological Center, Moscow, Russia.'}, {'ForeName': 'P L', 'Initials': 'PL', 'LastName': 'Khazan', 'Affiliation': 'N.A. Lopatkin Research Institute of Urology and Interventional Radiology branch of the National Medical Research Radiological Center, Moscow, Russia.'}, {'ForeName': 'Yu A', 'Initials': 'YA', 'LastName': 'Malova', 'Affiliation': 'N.A. Lopatkin Research Institute of Urology and Interventional Radiology branch of the National Medical Research Radiological Center, Moscow, Russia.'}]","Urologiia (Moscow, Russia : 1999)",[] 2244,32597584,[Method of complex therapy of chronic cystitis].,"AIM To assess the effectiveness of hydroxyethyldimethyldihydropyrimidine (trade name Xymedone) in the treatment of chronic recurrent cystitis in women. MATERIALS AND METHODS The study included 30 patients (the main group) with a confirmed diagnosis of chronic cystitis (HC) with a recurrence rate of at least 3 times a year, the average age of the patients was 46.0+/-2.7 years. The control group consisted of 30 age-comparable patients with a similar diagnosis, who underwent standard treatment for this disease. The article presents the results on the effectiveness of the use of hydroxyethyldimethyldihydropyrimidine (Xymedone) in the treatment of HC after anti-inflammatory and local treatment with collargol instillations, and the terms for the regeneration of the bladder mucosa are determined. To patients of the main group Xymedone was prescribed in a dose of 500 mg 3 times a day for 30 days after the completion of local treatment. Control cystoscopy was performed 15 and 30 days after the start of the drug, 3 days after its withdrawal. RESULTS The planned treatment was completed by all 30 patients of the main group. After 15 days from the date of administration of Xymedone most of patients had no low urinary tract symptoms (LUTS), in comparison with the control group. Cystoscopy performed at this time allowed to establish a positive trend while taking Xymedone in the process of restoring the bladder mucosa after influence of collargol. Hyperemia in the neck and triangle area persisted in most patients, and only in 8 (26.6%) it decreased. Treatment with Xymedone was continued. After 30 days of drug intake laboratory parameters were according to normal values, a significant increase in functional capacity of the bladder (189,5+/-19,8 ml) and volume of urination (147,9+/-26,7 ml.) was detected, the thickness of the bladder wall in a state of filling in the averages was 3.5+/- 0.3 mm, which corresponded to the norm. Cystoscopy, performed 3 days after canceling of the drug, showed a slight hyperemia in the bladder neck area only in one patient. Recurrence of HC in the control group occurred within 6 months after completion of treatment in 15 (51%) women. In the main group there were no relapses during two years of dynamic follow-up. CONCLUSIONS Hydroxyethyldimethyldihydropyrimidine, included in the therapy of HC, accelerates the regeneration of the bladder mucosa after local treatment of recurrent cystitis and shortens the period of its recovery, significantly lengthens the period of persistent remission.",2020,"After 30 days of drug intake laboratory parameters were according to normal values, a significant increase in functional capacity of the bladder (189,5+/-19,8 ml) and volume of urination (147,9+/-26,7 ml.) was detected, the thickness of the bladder wall in a state of filling in the averages was 3.5+/- 0.3 mm, which corresponded to the norm.","['chronic cystitis', 'chronic recurrent cystitis in women', '30 patients (the main group) with a confirmed diagnosis of chronic cystitis (HC) with a recurrence rate of at least 3 times a year, the average age of the patients was 46.0+/-2.7 years']","['complex therapy', 'Control cystoscopy', 'hydroxyethyldimethyldihydropyrimidine (trade name Xymedone', 'Xymedone', 'hydroxyethyldimethyldihydropyrimidine (Xymedone']","['functional capacity of the bladder (189,5+/-19,8 ml) and volume of urination', 'Hyperemia', 'Recurrence of HC']","[{'cui': 'C0221763', 'cui_str': 'Chronic cystitis'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0581366', 'cui_str': 'Recurrent cystitis'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517635', 'cui_str': '2.7'}]","[{'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0010702', 'cui_str': 'Cystoscopy'}]","[{'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0005682', 'cui_str': 'Urinary bladder structure'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0042034', 'cui_str': 'Micturition'}, {'cui': 'C0020452', 'cui_str': 'Hyperemia'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}]",30.0,0.035784,"After 30 days of drug intake laboratory parameters were according to normal values, a significant increase in functional capacity of the bladder (189,5+/-19,8 ml) and volume of urination (147,9+/-26,7 ml.) was detected, the thickness of the bladder wall in a state of filling in the averages was 3.5+/- 0.3 mm, which corresponded to the norm.","[{'ForeName': 'M E', 'Initials': 'ME', 'LastName': 'Sitdykova', 'Affiliation': 'Kazan State Medical University of the Ministry of Health of Russia, Kazan, Russia.'}, {'ForeName': 'E E', 'Initials': 'EE', 'LastName': 'Nikolsky', 'Affiliation': 'Kazan State Medical University of the Ministry of Health of Russia, Kazan, Russia.'}, {'ForeName': 'O A', 'Initials': 'OA', 'LastName': 'Birchuk', 'Affiliation': 'Kazan State Medical University of the Ministry of Health of Russia, Kazan, Russia.'}, {'ForeName': 'D R', 'Initials': 'DR', 'LastName': 'Sayapova', 'Affiliation': 'Kazan State Medical University of the Ministry of Health of Russia, Kazan, Russia.'}]","Urologiia (Moscow, Russia : 1999)",[] 2245,32597588,[Transurethral endopyelotomy using thulium fiber laser].,"INTRODUCTION Transurethral endopyelotomy is an alternative treatment method for short stricture of ureteropelvic junction (UPJ). AIM to evaluate the efficiency of transurethral thulium laser endopyelotomy. MATERIALS AND METHODS A total of 94 patients with UPJ obstruction during the period from December 2016 to December 2018 were prospectively enrolled in the study. Pelvic size did not exceed 3 cm in 31 patients, and it was in the range from 3 to 4 cm and more than 4 cm in 35 and 28 cases, respectively. Depending on the treatment, all patients were divided into 2 groups. The main group included 48 patients who underwent retrograde thulium fiber laser endopyelotomy. In the control group (n = 46), patients underwent Anderson-Hynes laparoscopic pyeloplasty. In the main group, there were significantly more patients with more preserved ipsilateral kidney function, with short (less than 1 cm) and recurrent UPJ strictures and less severe hydronephrosis compared to the control group. In addition, there were no patients with crossing vessel in the main group. Postoperatively, an internal stent of 6-8 Fr was put in all patients for a period of 6-8 weeks. After stent removal, all patients underwent a follow-up examination, including an ultrasound examination and, if pelvic size was more than 3 cm, contrast-enhanced CT-urography was performed. RESULTS In all patients, after stent removal, a decrease in the pelvic size was noted. The operation time in the main and control group was 24+/-14 minutes and 82+/-26 minutes, respectively. In all cases, ureteropyeloscopy was performed prior to laparoscopy to determine the exact length of stricture and to exclude narrowing of other parts of the ureter. After follow-up of 24 months, an examination in 36 patients of the main group and 29 patients of the control group was performed. There was 1 recurrence after laparoscopic pyeloplasty and 1 recurrence after endopyelotomy. In other patients of both groups, there were neither stricture, nor impaired renal function. CONCLUSION The first experience of using a thulium fiber laser for transurethral endoscopic treatment of UPJ obstruction is presented in the article. Indications for the transurethral thulium endopyelotomy are the presence of primary or secondary UPJ obstruction (with a decrease in kidney function by no more than 40%), length of up to 1 cm, absence of an additional vessel and pelvic dilatation of no more than 4 cm.",2020,"The operation time in the main and control group was 24+/-14 minutes and 82+/-26 minutes, respectively.","['94 patients with UPJ obstruction during the period from December 2016 to December 2018 were prospectively enrolled in the study', '48 patients who underwent']","['thulium fiber laser', 'Transurethral endopyelotomy', 'retrograde thulium fiber laser endopyelotomy', 'Anderson-Hynes laparoscopic pyeloplasty', 'laparoscopic pyeloplasty', 'transurethral thulium laser endopyelotomy', 'Transurethral endopyelotomy using thulium fiber laser']","['renal function', 'recurrent UPJ strictures', 'pelvic size', 'severe hydronephrosis', 'kidney function', 'ipsilateral kidney function', 'operation time', 'Pelvic size']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0521619', 'cui_str': 'Obstruction of pelviureteric junction'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0040066', 'cui_str': 'Thulium'}, {'cui': 'C0012173', 'cui_str': 'Dietary fiber'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0205497', 'cui_str': 'Transurethral approach'}, {'cui': 'C0439784', 'cui_str': 'Retrograde direction'}, {'cui': 'C0812509', 'cui_str': 'Laparoscopic pyeloplasty'}]","[{'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0227680', 'cui_str': 'Structure of ureteropelvic junction'}, {'cui': 'C1261287', 'cui_str': 'Stenosis'}, {'cui': 'C0030797', 'cui_str': 'Pelvic'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0020295', 'cui_str': 'Hydronephrosis'}, {'cui': 'C0232804', 'cui_str': 'Renal function'}, {'cui': 'C0441989', 'cui_str': 'Ipsilateral'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",94.0,0.0247955,"The operation time in the main and control group was 24+/-14 minutes and 82+/-26 minutes, respectively.","[{'ForeName': 'A G', 'Initials': 'AG', 'LastName': 'Martov', 'Affiliation': 'Department of Urology and Andrology of A.I. Burnazyan SRC FMBC, FMBA of Russia, GBUZ City clinical hospital named after D.D. Pletnev of the Health Department c. Moscow, Moscow, Russia.'}, {'ForeName': 'M Yu', 'Initials': 'MY', 'LastName': 'Golubev', 'Affiliation': 'Department of Urology and Andrology of A.I. Burnazyan SRC FMBC, FMBA of Russia, GBUZ City clinical hospital named after D.D. Pletnev of the Health Department c. Moscow, Moscow, Russia.'}, {'ForeName': 'D V', 'Initials': 'DV', 'LastName': 'Ergakov', 'Affiliation': 'Department of Urology and Andrology of A.I. Burnazyan SRC FMBC, FMBA of Russia, GBUZ City clinical hospital named after D.D. Pletnev of the Health Department c. Moscow, Moscow, Russia.'}, {'ForeName': 'P M', 'Initials': 'PM', 'LastName': 'Golubev', 'Affiliation': 'Department of Urology and Andrology of A.I. Burnazyan SRC FMBC, FMBA of Russia, GBUZ City clinical hospital named after D.D. Pletnev of the Health Department c. Moscow, Moscow, Russia.'}, {'ForeName': 'N A', 'Initials': 'NA', 'LastName': 'Baykov', 'Affiliation': 'Department of Urology and Andrology of A.I. Burnazyan SRC FMBC, FMBA of Russia, GBUZ City clinical hospital named after D.D. Pletnev of the Health Department c. Moscow, Moscow, Russia.'}, {'ForeName': 'A S', 'Initials': 'AS', 'LastName': 'Andronov', 'Affiliation': 'Department of Urology and Andrology of A.I. Burnazyan SRC FMBC, FMBA of Russia, GBUZ City clinical hospital named after D.D. Pletnev of the Health Department c. Moscow, Moscow, Russia.'}, {'ForeName': 'D A', 'Initials': 'DA', 'LastName': 'Abdullaev', 'Affiliation': 'Department of Urology and Andrology of A.I. Burnazyan SRC FMBC, FMBA of Russia, GBUZ City clinical hospital named after D.D. Pletnev of the Health Department c. Moscow, Moscow, Russia.'}]","Urologiia (Moscow, Russia : 1999)",[] 2246,32597672,Training reduces error in rating the intensity of emotions.,"The ability to recognize how another is feeling is a critical skill, with profound implications for social adaptation. Training programs designed to improve social functioning typically attempt to direct attention toward or away from certain facial configurations, or to improve discrimination between emotions by categorizing faces. However, emotion recognition involves processes in addition to attentional orienting or categorical labeling. The intensity with which someone is experiencing an emotion is also influential; knowing whether someone is annoyed or enraged will guide an observer's response. Here, we systematically examined a novel paradigm designed to improve ratings of facial information communicating emotion intensity in a sample of 492 participants across a series of 8 studies. In Study 1, participants improved precision in recognizing the intensity of facial cues through personalized corrective feedback. These initial findings were replicated in a randomized-control trial comparing training with feedback to viewing and rating faces without feedback. Studies 2 and 3 revealed that these effects generalize to identities and facial configurations not included in the training. Study 4 indicated that the effects were sustained beyond the training session. These findings suggest that individualized, corrective feedback is effective for reducing error in rating the intensity of facial cues. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,"In Study 1, participants improved precision in recognizing the intensity of facial cues through personalized corrective feedback.",['492 participants across a series of 8 studies'],[],['ratings of facial information communicating emotion intensity'],"[{'cui': 'C0205549', 'cui_str': 'Series'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]",[],"[{'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0205196', 'cui_str': 'Communicating'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}]",1.0,0.0315909,"In Study 1, participants improved precision in recognizing the intensity of facial cues through personalized corrective feedback.","[{'ForeName': 'Brian T', 'Initials': 'BT', 'LastName': 'Leitzke', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Rista C', 'Initials': 'RC', 'LastName': 'Plate', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Seth D', 'Initials': 'SD', 'LastName': 'Pollak', 'Affiliation': 'Department of Psychology.'}]","Emotion (Washington, D.C.)",['10.1037/emo0000763'] 2247,32597673,The future is now: Age-progressed images motivate community college students to prepare for their financial futures.,"Part of the challenge young people face when preparing for lifelong financial security is visualizing the far-off future. Age-progression technology has been shown to motivate young people to save for retirement. The current study applied age progression for motivating socioeconomically diverse community college students as part of a college planning course. We recruited 106 students enrolled in a mandatory ""Transitioning to College"" course and randomly assigned them to view age-progressed or same-aged digital avatars. Compared to controls, age-progressed participants gave more correct answers and exhibited higher confidence (i.e., fewer ""don't know"" responses) on a financial literacy test. Confidence mediated the effect of age progression on correct responses, but not the other way around, pointing to financial confidence as a precursor to effective financial education. Students also reported interest in attending more long-term financial planning workshops (e.g., investing and retirement) available through their college. No differences were observed in financial planning for the near term (e.g., student aid and credit cards). The current study demonstrates the viability of age progression as a practical, inexpensive, and scalable intervention. Findings also illustrate the significance of this intervention for reducing pervasive socioeconomic and age disparities in financial knowledge and enhancing long-term financial prospects across future generations. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,"No differences were observed in financial planning for the near term (e.g., student aid and credit cards).","['motivating socioeconomically diverse community college students', '106 students enrolled in a mandatory ""Transitioning to College"" course and randomly assigned them to view age-progressed or same-aged digital avatars']",[],['financial planning'],"[{'cui': 'C0557812', 'cui_str': 'Community college'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}]",[],"[{'cui': 'C0376243', 'cui_str': 'finances'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning'}]",106.0,0.0189586,"No differences were observed in financial planning for the near term (e.g., student aid and credit cards).","[{'ForeName': 'Tamara', 'Initials': 'T', 'LastName': 'Sims', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Raposo', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Jeremy N', 'Initials': 'JN', 'LastName': 'Bailenson', 'Affiliation': 'Department of Communication.'}, {'ForeName': 'Laura L', 'Initials': 'LL', 'LastName': 'Carstensen', 'Affiliation': 'Department of Psychology.'}]",Journal of experimental psychology. Applied,['10.1037/xap0000275'] 2248,32597686,Effect of Low-Pressure Drainage Suction on Pharyngocutaneous Fistula After Total Laryngectomy.,"OBJECTIVE Pharyngocutaneous fistula (PCF) is one of the most severe multifactorial complications following laryngectomy. The current study aimed at determining the effect of a low-pressure vacuum drain on the incidence of PCF after total laryngectomy. METHODS The current randomized clinical trial was conducted on 35 patients undergoing total laryngectomy in Hazrat Rasoul Akram and Firoozgar hospitals in Tehran, Iran. The subjects were divided into the vacuum drain (n = 15) and control (without vacuum drain) (n = 20) groups. The incidence of PCF and the recovery time were recorded. RESULTS The rate of PCF formation from the stoma and wound edges was significantly lower in the low-pressure vacuum drain group than in the control group (6.7% vs 40%) ( P  < .05). There was no significant difference between the groups in time to recovery from PCF. CONCLUSION The low-pressure vacuum drain method is effective in reducing the incidence of PCF after total laryngectomy.",2020,The rate of PCF formation from the stoma and wound edges was significantly lower in the low-pressure vacuum drain group than in the control group (6.7% vs 40%) ( P  < .05).,"['35 patients undergoing total laryngectomy in Hazrat Rasoul Akram and Firoozgar hospitals in Tehran, Iran']","['Low-Pressure Drainage Suction', 'vacuum drain (n\u2009=\u200915) and control (without vacuum drain', 'low-pressure vacuum drain']","['incidence of PCF and the recovery time', 'rate of PCF formation from the stoma and wound edges', 'Pharyngocutaneous Fistula']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0189231', 'cui_str': 'Total laryngectomy'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0022065', 'cui_str': 'Iran'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0038638', 'cui_str': 'Suction drainage'}, {'cui': 'C0042221', 'cui_str': 'Vacuum'}, {'cui': 'C0013103', 'cui_str': 'Drainage procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0396009', 'cui_str': 'Pharyngocutaneous fistula'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C1955856', 'cui_str': 'Stoma site'}, {'cui': 'C1545981', 'cui_str': 'Wound edge observable'}]",35.0,0.047613,The rate of PCF formation from the stoma and wound edges was significantly lower in the low-pressure vacuum drain group than in the control group (6.7% vs 40%) ( P  < .05).,"[{'ForeName': 'Mojtaba', 'Initials': 'M', 'LastName': 'Maleki Delarestaghi', 'Affiliation': 'Associate Professor of Otolaryngology, ENT and Head & Neck Research Center and Department, The Five Senses Institute, Firoozgar Hospital, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Aslan', 'Initials': 'A', 'LastName': 'Ahmadi', 'Affiliation': 'Assistant Professor of Otolaryngology, ENT and Head and Neck Research Center and Department, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Dehghani Firouzabadi', 'Affiliation': 'Clinical Researcher, ENT and Head and Neck Research Center and Department, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Roomiani', 'Affiliation': 'Clinical Researcher, ENT and Head and Neck Research Center and Department, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Dehghani Firouzabadi', 'Affiliation': 'Clinical Researcher, ENT and Head and Neck Research Center and Department, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Zhaleh', 'Initials': 'Z', 'LastName': 'Faham', 'Affiliation': 'Clinical Researcher, ENT and Head and Neck Research Center and Department, Iran University of Medical Sciences, Tehran, Iran.'}]","The Annals of otology, rhinology, and laryngology",['10.1177/0003489420934506'] 2249,32597691,"Effect of Chinese Herbal Compound LC09 on Patients With Capecitabine-Associated Hand-Foot Syndrome: A Randomized, Double-Blind, and Parallel-Controlled Trial.","Background: LC09 is composed with 5 kinds of traditional Chinese herbal medicines ( Astragalus membranaceus , flowers carthami, lithospermum, geranium wilfordii, and radix angelicae) which are used in China and developed over several thousand years. Aim: To assess the effectiveness and safety of herbal compound LC09 on patients with capecitabine-associated hand-foot syndrome (HFS). Materials and Methods: In this randomized, double-blind, and parallel-controlled study, 156 patients that diagnosed with HFS were randomly assigned to a treatment group (n = 78) or control group (n = 78). Patients were evaluated every week by the National Cancer Institute (NCI) grade and Numerical Rating Scale (NRS) pain scores. The Dermatology Life Quality Index (DLQI) scale and Instrumental Activity of Daily Living (IADL) scale were used to assess the quality of life before the treatment, and at 1 week and after the treatment of 2 cycles. Results: At the baseline, no significant differences were observed between the 2 groups. After treatment, significant differences in NCI grade and NRS pain scores were observed between the 2 groups ( P < .01). In addition, HFS effectiveness rate and pain alleviation rate were significantly higher in the treatment group compared with the control group ( P < .01). Furthermore, the chemotherapy completion rate between 2 groups was significantly different ( P = .002). In addition, no adverse reactions were observed in either LC09 or control group. Conclusion: LC09 can decrease NCI grade and significantly alleviate pain in HFS patients. Besides, it can also increase chemotherapy completion rate.",2020,"In addition, HFS effectiveness rate and pain alleviation rate were significantly higher in the treatment group compared with the control group ( P < .01).","['156 patients that diagnosed with HFS', 'Patients With Capecitabine-Associated Hand-Foot Syndrome', 'patients with capecitabine-associated hand-foot syndrome (HFS', 'HFS patients']","['LC09', 'herbal compound LC09', 'Chinese Herbal Compound LC09']","['quality of life', 'NCI grade and NRS pain scores', 'NCI grade', 'National Cancer Institute (NCI) grade and Numerical Rating Scale (NRS) pain scores', 'HFS effectiveness rate and pain alleviation rate', 'chemotherapy completion rate', 'adverse reactions', 'alleviate pain', 'Dermatology Life Quality Index (DLQI) scale and Instrumental Activity of Daily Living (IADL) scale']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C2745948', 'cui_str': 'Juvenile hyaline fibromatosis'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0549410', 'cui_str': 'Palmar-plantar erythrodysaesthesia syndrome'}]","[{'cui': 'C0376667', 'cui_str': 'Herbals'}, {'cui': 'C0205198', 'cui_str': 'Compound'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0560007', 'cui_str': 'nCi'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C1513882', 'cui_str': 'National Cancer Institute'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C2745948', 'cui_str': 'Juvenile hyaline fibromatosis'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0559546', 'cui_str': 'Adverse reaction'}, {'cui': 'C0451112', 'cui_str': 'Dermatology life quality index'}, {'cui': 'C0150641', 'cui_str': 'Instrumental activities of daily living'}]",156.0,0.231078,"In addition, HFS effectiveness rate and pain alleviation rate were significantly higher in the treatment group compared with the control group ( P < .01).","[{'ForeName': 'Ran', 'Initials': 'R', 'LastName': 'Yu', 'Affiliation': 'Beijing University of Chinese Medicine, Beijing, China.'}, {'ForeName': 'Xuefeng', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': 'Keio University, Tokyo, Japan.'}, {'ForeName': 'Liqun', 'Initials': 'L', 'LastName': 'Jia', 'Affiliation': 'China-Japan Friendship Hospital, Beijing, China.'}, {'ForeName': 'Yanni', 'Initials': 'Y', 'LastName': 'Lou', 'Affiliation': 'China-Japan Friendship Hospital, Beijing, China.'}]",Integrative cancer therapies,['10.1177/1534735420928466'] 2250,32597700,Enhancing food habits via sensitivity in rural low-SES mothers of children aged 1-3 living in Colombia: a randomized controlled trial using video-feedback intervention.,"In a randomized controlled trial with 25 Colombian rural low-SES mothers and their children (aged 1-3 years), the effectiveness of the Video-feedback Intervention to promote Positive Parenting and Sensitive Discipline (VIPP-SD) in enhancing maternal sensitivity and food habits was tested pre-intervention, post-intervention, and at a 6-month follow-up. The study further verified whether maternal sensitivity represented a mechanism of change for food habits. Mixed models indicated that the VIPP-SD did promote higher maternal sensitivity and better food habits. Moreover, increased maternal sensitivity following the VIPP-SD predicted improved maternal food habits, both post-intervention and at the follow-up. The findings suggest that interventions aimed at preventing early inadequate parental food habits in low-SES communities should promote sensitive parenting during daily mother-child interactions, in addition to offering nutritional advice.",2020,"Moreover, increased maternal sensitivity following the VIPP-SD predicted improved maternal food habits, both post-intervention and at the follow-up.","['rural low-SES mothers of children aged 1-3 living in Colombia', '25 Colombian rural low-SES mothers and their children (aged 1-3\xa0years']","['Video-feedback Intervention to promote Positive Parenting and Sensitive Discipline (VIPP-SD', 'video-feedback intervention']","['maternal sensitivity', 'maternal food habits', 'maternal sensitivity and better food habits']","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C3245499', 'cui_str': 'Colombia'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0085092', 'cui_str': 'Parenting behavior'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}]","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0016468', 'cui_str': 'Eating Habits'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}]",25.0,0.0674306,"Moreover, increased maternal sensitivity following the VIPP-SD predicted improved maternal food habits, both post-intervention and at the follow-up.","[{'ForeName': 'Lavinia', 'Initials': 'L', 'LastName': 'Barone', 'Affiliation': 'Department of Brain and Behavioral Sciences, Lab on Attachment and Parenting LAG, University of Pavia , Pavia, Italy.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Carone', 'Affiliation': 'Department of Brain and Behavioral Sciences, Lab on Attachment and Parenting LAG, University of Pavia , Pavia, Italy.'}, {'ForeName': 'Juan-Gabriel', 'Initials': 'JG', 'LastName': 'Salazar-Jimenez', 'Affiliation': 'Fundación Universitaria Juan de Castellanos , Tunja, Colombia.'}, {'ForeName': 'Jenny Amanda', 'Initials': 'JA', 'LastName': 'Ortíz Muñoz', 'Affiliation': 'Escuela de Medicina y Ciencias de la Salud, Universidad del Rosario , Bogotá, Colombia.'}]",Attachment & human development,['10.1080/14616734.2020.1784243'] 2251,32598060,The Effect of a Skin Barrier Film on the Incidence of Dressing-Related Skin Blisters After Spine Surgery.,"Tension blisters from adhesive dressings may lead to pain and delayed surgical wound healing for surgical patients and cause an institutional cost burden. Commercial skin barrier film products may reduce dressing-related postoperative skin blistering in surgical patients. Project investigators at an orthopedic specialty hospital randomized 185 surgical spine patients to receive either a standard wound dressing (ie, control group) or a dressing with the addition of a skin barrier film applied beneath it (eg, treatment group). During the first postoperative dressing change, the participants' skin was assessed for redness, soreness, blistering, or tearing. Approximately 15% of participants in the treatment group and 15% of participants in the control group developed a postoperative skin injury (P = .98). Multivariable analyses did not indicate the skin barrier film provided a protective effect. Additionally, there was no association between patient-specific characteristics and skin blisters among the participants. These results do not support the use of a skin barrier film in surgical spine patients.",2020,Approximately 15% of participants in the treatment group and 15% of participants in the control group developed a postoperative skin injury (P = .98).,"['surgical spine patients', '185 surgical spine patients', 'surgical patients']","['standard wound dressing (ie, control group) or a dressing with the addition of a skin barrier film applied beneath it', 'Skin Barrier Film', 'Commercial skin barrier film products']","['postoperative skin injury', 'redness, soreness, blistering, or tearing', 'Incidence of Dressing-Related Skin Blisters', 'patient-specific characteristics and skin blisters']","[{'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0037949', 'cui_str': 'Structure of vertebral column'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517617', 'cui_str': '185'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0460765', 'cui_str': 'Wound management dressing'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0013119', 'cui_str': 'Medical dressing'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C1704608', 'cui_str': 'Film'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0281980', 'cui_str': 'Injury of integument'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0234233', 'cui_str': 'Soreness'}, {'cui': 'C0005758', 'cui_str': 'Blister'}, {'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0013119', 'cui_str': 'Medical dressing'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205369', 'cui_str': 'Specific'}]",185.0,0.0325508,Approximately 15% of participants in the treatment group and 15% of participants in the control group developed a postoperative skin injury (P = .98).,"[{'ForeName': 'Maryanne', 'Initials': 'M', 'LastName': 'Cole', 'Affiliation': ''}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Smith', 'Affiliation': ''}, {'ForeName': 'Steven C', 'Initials': 'SC', 'LastName': 'Vlad', 'Affiliation': ''}, {'ForeName': 'Samuel W', 'Initials': 'SW', 'LastName': 'Golenbock', 'Affiliation': ''}, {'ForeName': 'Kerry', 'Initials': 'K', 'LastName': 'Sorrentino', 'Affiliation': ''}]",AORN journal,['10.1002/aorn.13074'] 2252,32598090,Effect of information and exercise programmes after lumbar disc surgery: A randomized controlled trial.,"OBJECTIVE The aim of this study was to compare two physiotherapy interventions following lumber disc surgery regarding effect on pain, functioning and fear of movement. METHODS This study is a prospective randomized controlled study. When admitted to hospital for first time lumbar disc surgery, the participants were randomized to one of two post-operative intervention groups: one group received information only and the other exercise in combination with information. Outcomes were collected at baseline, 6-8 weeks and 12-months post-surgery. The primary outcome was to record changes in back/hip pain and leg pain. Secondary outcomes were evaluation of changes in function, fear-avoidance beliefs and kinesiophobia. RESULTS Seventy patients completed the study and were included in the analysis, of which 37 were randomized to the group receiving information only and the remaining 33 receiving both exercise and information. For primary outcomes, at 12 months postoperatively, the group receiving both exercise and information had significantly lower leg pain compared with those receiving only information (p < .033). For secondary outcomes, at 12 months postoperatively, a significant difference (p < .027) was detected for function, which favoured those that received both exercise and information. There was no significant difference in the results for the other secondary outcomes. Both groups showed clinically important changes in relation to pain and function from baseline to 12 months. The effect of treatment showed a statistically significant difference in favour of exercise and information, but the difference was not clinically relevant. CONCLUSION Exercise in combination with information reduced leg pain and improved function, which was statistically more evident over a period of time. Postoperative physiotherapy after lumbar disc surgery could include exercises in addition to information, but perhaps not for all patients, as both groups improved, and the difference between the two groups was not clinically relevant.",2020,"The effect of treatment showed a statistically significant difference in favour of exercise and information, but the difference was not clinically relevant. ","['lumbar disc surgery', 'Seventy patients completed the study and were included in the analysis, of which 37']","['information and exercise programmes', 'information only and the other exercise in combination with information']","['leg pain', 'record changes in back/hip pain and leg pain', 'leg pain and improved function', 'pain, functioning and fear of movement', 'evaluation of changes in function, fear-avoidance beliefs and kinesiophobia']","[{'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0023222', 'cui_str': 'Pain in lower limb'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0019559', 'cui_str': 'Hip pain'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C4285782', 'cui_str': 'Kinesiophobia'}]",37.0,0.202768,"The effect of treatment showed a statistically significant difference in favour of exercise and information, but the difference was not clinically relevant. ","[{'ForeName': 'Eva Saltskår', 'Initials': 'ES', 'LastName': 'Jentoft', 'Affiliation': 'Orthopedic Clinic Kysthospitalet in Hagevik, Haukeland University Hospital, Bergen, Norway.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Kvåle', 'Affiliation': 'Western Norway University of Applied Sciences, Bergen, Norway.'}, {'ForeName': 'Jörg', 'Initials': 'J', 'LastName': 'Assmus', 'Affiliation': 'Centre for Clinical Research, Haukeland University Hospital, Bergen, Norway.'}, {'ForeName': 'Vegard Pihl', 'Initials': 'VP', 'LastName': 'Moen', 'Affiliation': 'Western Norway University of Applied Sciences, Bergen, Norway.'}]",Physiotherapy research international : the journal for researchers and clinicians in physical therapy,['10.1002/pri.1864'] 2253,32593274,Why USB-endoscope laryngoscopy is as effective as video laryngoscopy.,"PURPOSE To compare the efficacy of a low-cost custom-made universal serial bus (USB) endoscope laryngoscope for intubation with a direct laryngoscope and a high-cost video laryngoscope in a mannequin study. METHODS We used one intubation simulator model (mannequin) in our study. A USB endoscope was mounted to the direct laryngoscope as a custom-made USB endoscope laryngoscope (USB-L). We used a video laryngoscope (Glidescope®, Verathon, USA) and a direct laryngoscope (Macintosh) for comparison. Intubation time and the correct placement of the tube were measured. Intubations were performed by two operators and results were compared. RESULTS We found a statistically significant difference between the video and direct laryngoscope groups (p < 0.001), as well as between the USB-L and direct laryngoscope groups (p = 0.001) for Operator 1. For Operator 2, there was a statistically significant difference between the video laryngoscope group and the direct laryngoscope group (p = 0.022); however, we did not find a significant difference between the USB-L group and the direct laryngoscope group (p = 0.154). Furthermore, there were no significant differences between the USB-L and video laryngoscope groups for either operator (p=0.347 for Operator 1 and p>0.999 for Operator 2). CONCLUSION Our study showed that USB endoscope laryngoscope provided similar intubation time to video laryngoscopy at a fraction of the cost; and both had superior times in comparison with direct laryngoscopy.",2020,"We found a statistically significant difference between the video and direct laryngoscope groups (p < 0.001), as well as between the USB-L and direct laryngoscope groups (p = 0.001) for Operator 1.",[],"['video laryngoscope (Glidescope®, Verathon, USA) and a direct laryngoscope (Macintosh', 'USB-endoscope laryngoscopy', 'intubation simulator model (mannequin', 'USB endoscope laryngoscope', 'low-cost custom-made universal serial bus (USB) endoscope laryngoscope']","['intubation time', 'Intubation time']",[],"[{'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0180453', 'cui_str': 'Laryngoscope'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0175671', 'cui_str': 'Universal'}, {'cui': 'C0031082', 'cui_str': 'Periodicals'}, {'cui': 'C0006463', 'cui_str': 'Busulfan'}, {'cui': 'C0014243', 'cui_str': 'Endoscope'}, {'cui': 'C0023072', 'cui_str': 'Laryngoscopy'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0183309', 'cui_str': 'Simulator'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0024722', 'cui_str': 'Mannequins'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0162343', 'cui_str': 'Customs'}]","[{'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",2.0,0.0221008,"We found a statistically significant difference between the video and direct laryngoscope groups (p < 0.001), as well as between the USB-L and direct laryngoscope groups (p = 0.001) for Operator 1.","[{'ForeName': 'Meliha', 'Initials': 'M', 'LastName': 'Findik', 'Affiliation': 'Balikesir University Faculty of Medicine, Department of Emergency, Balikesir, Turkey.'}, {'ForeName': 'Afsin E', 'Initials': 'AE', 'LastName': 'Kayipmaz', 'Affiliation': 'Ankara City Hospital, Department of Emergency, Ankara, Turkey. draekayipmaz@gmail.com.'}, {'ForeName': 'Cemil', 'Initials': 'C', 'LastName': 'Kavalci', 'Affiliation': 'Ankara Diskapi Yildirim Beyazit Training and Research Hospital, Department of Emergency, Ankara, Turkey.'}, {'ForeName': 'Tugce Sencelikel', 'Initials': 'TS', 'LastName': 'Sencelikel', 'Affiliation': 'Baskent University Faculty of Medicine, Department of Biostatistics, Ankara, Turkey.'}, {'ForeName': 'Murat', 'Initials': 'M', 'LastName': 'Muratoglu', 'Affiliation': 'Baskent University Faculty of Medicine, Department of Emergency, Ankara, Turkey.'}, {'ForeName': 'Aysegul', 'Initials': 'A', 'LastName': 'Akcebe', 'Affiliation': 'Kiziltepe State Hospital, Department of Emergency, Mardin, Turkey.'}, {'ForeName': 'Bulent', 'Initials': 'B', 'LastName': 'Gungorer', 'Affiliation': 'Ankara City Hospital, Department of Emergency, Ankara, Turkey.'}, {'ForeName': 'Gulsum', 'Initials': 'G', 'LastName': 'Kavalci', 'Affiliation': 'Yenimahalle Training and Research Hospital, Department of Anesthesiology, Ankara, Turkey.'}]",Clinical and investigative medicine. Medecine clinique et experimentale,['10.25011/cim.v43i2.33956'] 2254,32593287,High-flow nasal cannula improves clinical efficacy of airway management in patients undergoing awake craniotomy.,"BACKGROUND Awake craniotomy requires specific sedation procedure in an awake patient who should be able to cooperate during the intraoperative neurological assessment. Currently, limited number of literatures on the application of high-flow nasal cannula (HFNC) in the anesthetic management for awake craniotomy has been reported. Hence, we carried out a prospective study to assess the safety and efficacy of humidified high-flow nasal cannula (HFNC) airway management in the patients undergoing awake craniotomy. METHODS Sixty-five patients who underwent awake craniotomy were randomly assigned to use HFNC with oxygen flow rate at 40 L/min or 60 L/min, or nasopharynx airway (NPA) device in the anesthetic management. Data regarding airway management, intraoperative blood gas analysis, intracranial pressure, gastric antral volume, and adverse events were collected and analyzed. RESULTS Patients using HFNC with oxygen flow rate at 40 or 60 L/min presented less airway obstruction and injuries. Patients with HFNC 60 L/min maintained longer awake time than the patients with NPA. While the intraoperative PaO 2 and SPO 2 were not significantly different between the HFNC and NPA groups, HFNC patients achieved higher PaO 2 /FiO 2 than patients with NPA. There were no differences in Brain Relaxation Score and gastric antral volume among the three groups as well as before and after operation in any of the three groups. CONCLUSION HFNC was safe and effective for the patients during awake craniotomy. TRIAL REGISTRATION Chinese Clinical Trial Registry, CHiCTR1800016621 . Date of Registration: 12 June 2018.",2020,"There were no differences in Brain Relaxation Score and gastric antral volume among the three groups as well as before and after operation in any of the three groups. ","['Sixty-five patients who underwent awake craniotomy', 'patients undergoing awake craniotomy']","['humidified high-flow nasal cannula (HFNC) airway management', 'HFNC with oxygen flow rate at 40\u2009L/min or 60\u2009L/min, or nasopharynx airway (NPA) device', 'HFNC', 'High-flow nasal cannula']","['Brain Relaxation Score and gastric antral volume', 'safety and efficacy', 'intraoperative blood gas analysis, intracranial pressure, gastric antral volume, and adverse events', 'oxygen flow rate', 'airway obstruction and injuries']","[{'cui': 'C0450385', 'cui_str': '65'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0234422', 'cui_str': 'Awake'}, {'cui': 'C0010280', 'cui_str': 'Craniotomy'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0179574', 'cui_str': 'Nasal Cannulae'}, {'cui': 'C0150126', 'cui_str': 'Airway management'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0439393', 'cui_str': 'L/min'}, {'cui': 'C0027442', 'cui_str': 'Nasopharyngeal'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]","[{'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0035028', 'cui_str': 'Relaxation'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0038351', 'cui_str': 'Stomach'}, {'cui': 'C0293352', 'cui_str': 'Antral'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0005800', 'cui_str': 'Blood gas analysis'}, {'cui': 'C0021880', 'cui_str': 'Intracranial pressure'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0001883', 'cui_str': 'Respiratory obstruction'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}]",65.0,0.0784692,"There were no differences in Brain Relaxation Score and gastric antral volume among the three groups as well as before and after operation in any of the three groups. ","[{'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Yi', 'Affiliation': 'Department of Anesthesiology, Huashan Hospital, Fudan University, No.12 Wulumuqi Zhong Road, Shanghai, 200040, China.'}, {'ForeName': 'Qiong', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': 'Department of Anesthesiology, Shanghai Jiahui International Hospital, Shanghai, 200000, China.'}, {'ForeName': 'Zhoujing', 'Initials': 'Z', 'LastName': 'Yang', 'Affiliation': 'Department of Anesthesiology, Huashan Hospital, Fudan University, No.12 Wulumuqi Zhong Road, Shanghai, 200040, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Cao', 'Affiliation': 'Department of Anesthesiology, Huashan Hospital, Fudan University, No.12 Wulumuqi Zhong Road, Shanghai, 200040, China.'}, {'ForeName': 'Xiaobing', 'Initials': 'X', 'LastName': 'Hu', 'Affiliation': 'Department of Anesthesiology, Huashan Hospital, Fudan University, No.12 Wulumuqi Zhong Road, Shanghai, 200040, China.'}, {'ForeName': 'Huahua', 'Initials': 'H', 'LastName': 'Gu', 'Affiliation': 'Department of Anesthesiology, Huashan Hospital, Fudan University, No.12 Wulumuqi Zhong Road, Shanghai, 200040, China. ghhmzk@sina.com.'}]",BMC anesthesiology,['10.1186/s12871-020-01073-z'] 2255,32601909,Impact of postoperative complications on survival outcomes in patients with gastric cancer: exploratory analysis of a randomized controlled JCOG1001 trial.,"BACKGROUND Recent studies have found a negative impact of postoperative complications on long-term survival outcomes, but it has not been confirmed by data obtained from a prospective study with a large sample size. This study investigated the impact of postoperative complications on long-term survival outcomes, and considered the optimal definition of complication, using data from JCOG1001, which compared bursectomy and non-bursectomy for patients with cT3/4a locally advanced gastric cancer. METHODS This study included 1191 of 1204 patients enrolled in the JCOG1001 trial. Complications were graded by Clavien-Dindo (C-D) classification. Impact of the grade (≥ C-D grade II or ≥ grade III) or type (any or intra-abdominal infectious) of complication on survival outcome was evaluated by univariate and multivariable analyses using the Cox proportional hazard model. RESULTS The incidence of any ≥ C-D grade II and ≥ grade III complication was 23.0% and 9.7%, respectively, and that of ≥ grade II and ≥ grade III intra-abdominal infectious complication was 13.4% and 6.9%, respectively. Multivariable analysis showed all four definitions of complications were independent prognostic factors for overall survival. Conversely, only  any ≥ C-D grade III complication was found to be an independent prognostic factor for relapse-free survival (hazard ratio, 1.445; 95% confidence interval, 1.026-2.036; P = 0.035). CONCLUSIONS Postoperative complications adversely affect the long-term survival outcomes of patients with cT3/4a gastric cancer. Any ≥ C-D grade III complication seems to be the most suitable definition of complication for predicting negative long-term survival outcomes.",2020,Multivariable analysis showed all four definitions of complications were independent prognostic factors for overall survival.,"['patients with gastric cancer', 'patients with cT3/4a gastric cancer', 'patients with cT3/4a locally advanced gastric cancer', '1191 of 1204 patients enrolled in the JCOG1001 trial']",[],"['overall survival', 'grade III intra-abdominal infectious complication', 'relapse-free survival', 'incidence of any\u2009≥\u2009C-D grade II and\u2009≥\u2009grade III complication', 'survival outcomes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024623', 'cui_str': 'Malignant tumor of stomach'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]",[],"[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205617', 'cui_str': 'Poorly differentiated'}, {'cui': 'C1512911', 'cui_str': 'Intraabdominal route'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",1204.0,0.195615,Multivariable analysis showed all four definitions of complications were independent prognostic factors for overall survival.,"[{'ForeName': 'Masanori', 'Initials': 'M', 'LastName': 'Tokunaga', 'Affiliation': 'Department of Gastrointestinal Surgery, Tokyo Medical and Dental University, 1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan. tokunaga.srg1@tmd.ac.jp.'}, {'ForeName': 'Yukinori', 'Initials': 'Y', 'LastName': 'Kurokawa', 'Affiliation': 'Department of Gastroenterological Surgery, Osaka University Graduate School of Medicine, Osaka, Japan.'}, {'ForeName': 'Ryunosuke', 'Initials': 'R', 'LastName': 'Machida', 'Affiliation': 'Japan Clinical Oncology Group Data Center/Operations Office, National Cancer Centre Hospital, Tokyo, Japan.'}, {'ForeName': 'Yuya', 'Initials': 'Y', 'LastName': 'Sato', 'Affiliation': 'Japan Clinical Oncology Group Data Center/Operations Office, National Cancer Centre Hospital, Tokyo, Japan.'}, {'ForeName': 'Shuji', 'Initials': 'S', 'LastName': 'Takiguchi', 'Affiliation': 'Department of Gastroenterological Surgery, Osaka University Graduate School of Medicine, Osaka, Japan.'}, {'ForeName': 'Yuichiro', 'Initials': 'Y', 'LastName': 'Doki', 'Affiliation': 'Department of Gastroenterological Surgery, Osaka University Graduate School of Medicine, Osaka, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Yabusaki', 'Affiliation': 'Gastroenterological Surgery, Niigata Cancer Center Hospital, Niigata, Japan.'}, {'ForeName': 'Masaya', 'Initials': 'M', 'LastName': 'Watanabe', 'Affiliation': 'Department of Gastroenterological Surgery, Shizuoka General Hospital, Shizuoka, Japan.'}, {'ForeName': 'Shinji', 'Initials': 'S', 'LastName': 'Hato', 'Affiliation': 'Department of Gastroenterological Surgery, National Hospital Organization Shikoku Cancer Center, Matsuyama, Japan.'}, {'ForeName': 'Mikihito', 'Initials': 'M', 'LastName': 'Nakamori', 'Affiliation': 'Second Department of Surgery, School of Medicine, Wakayama Medical University, Wakayama, Japan.'}, {'ForeName': 'Seiji', 'Initials': 'S', 'LastName': 'Ito', 'Affiliation': 'Department of Gastroenterological Surgery, Aichi Cancer Center Hospital, Nagoya, Japan.'}, {'ForeName': 'Takaki', 'Initials': 'T', 'LastName': 'Yoshikawa', 'Affiliation': 'Gastric Surgery Division, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Masanori', 'Initials': 'M', 'LastName': 'Terashima', 'Affiliation': 'Division of Gastric Surgery, Shizuoka Cancer Center, Nagaizumi, Japan.'}]",Gastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association,['10.1007/s10120-020-01102-3'] 2256,32601915,Baloxavir Marboxil: A Review in Acute Uncomplicated Influenza.,"Baloxavir marboxil (Xofluza ® ; hereafter referred to as baloxavir), the prodrug of baloxavir acid, is a first-in-class, small molecule inhibitor of the polymerase acidic (PA) protein subunit of the influenza virus polymerase complex. Baloxavir (after conversion to baloxavir acid) acts to block influenza virus replication by inhibiting the cap-dependent endonuclease activity of the PA protein. Taken orally as a single dose, baloxavir is approved in the USA for the treatment of acute uncomplicated influenza in patients ≥ 12 years of age who have been symptomatic for ≤ 48 h. Data from randomized, double-blind, placebo- and oseltamivir-controlled phase III trials have shown that baloxavir is efficacious in improving influenza symptoms both in otherwise healthy adolescents and adults and in those at high risk of influenza complications, displaying similar efficacy to that of oseltamivir. Furthermore, there is evidence that baloxavir can reduce influenza viral load more rapidly than oseltamivir. Baloxavir has activity against influenza A and B viruses (including strains resistant to neuraminidase inhibitors) and is well tolerated. Evidence of the emergence and likely human-to-human transmission of variant viruses with reduced susceptibility to baloxavir highlights the importance of monitoring and surveillance for changes in influenza virus drug susceptibility patterns. However, currently available evidence suggests that baloxavir, with the benefits of a single oral dose regimen, provides a useful alternative to neuraminidase inhibitors for the treatment of acute uncomplicated influenza in adolescents and adults.",2020,Baloxavir has activity against influenza ,"['acute uncomplicated influenza in adolescents and adults', 'acute uncomplicated influenza in patients ≥\xa012\xa0years of age who have been symptomatic for ≤\xa048']","['Baloxavir', 'baloxavir', 'Baloxavir Marboxil', 'Baloxavir marboxil (Xofluza ® ', 'placebo- and oseltamivir-controlled phase']",[],"[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0443334', 'cui_str': 'Uncomplicated'}, {'cui': 'C0021400', 'cui_str': 'Influenza'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}]","[{'cui': 'C4734224', 'cui_str': 'baloxavir'}, {'cui': 'C4688747', 'cui_str': 'Baloxavir marboxil'}, {'cui': 'C4734327', 'cui_str': 'Xofluza'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0874161', 'cui_str': 'Oseltamivir'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205390', 'cui_str': 'Phase'}]",[],,0.105801,Baloxavir has activity against influenza ,"[{'ForeName': 'Matt', 'Initials': 'M', 'LastName': 'Shirley', 'Affiliation': 'Springer Nature, Private Bag 65901, Mairangi Bay, Auckland, 0754, New Zealand. demail@springer.com.'}]",Drugs,['10.1007/s40265-020-01350-8'] 2257,32601919,The effect of applying amniotic membrane on post-tonsillectomy pain and bleeding.,"PURPOSE Pain and hemorrhage are common morbidities after tonsillectomy. Although many studies have focused on post-tonsillectomy pain, inadequate researches are available on wound healing. Hence, there is a definite need for a novel technique to facilitate the healing process and thereby improving the post-tonsillectomy recovery. METHODS This prospective and randomized study was conducted on 60 adult patients who underwent tonsillectomy. They were divided into two groups of control and amniotic membrane (AM). Human amniotic membrane was applied over the tonsillar bed as a biologic dressing. Post-tonsillectomy pain and bleeding were evaluated. Also, the healing rate was assessed on days 5, 10 and 15 post-operatively. RESULTS The pain score in the AM group was lower than that in the control group during the first week after surgery (P < 0.0001). Moreover, the AM group returned faster to their normal diet in comparison with the control group (P < 0.0001). With respect to the healing rate, there were no significant differences between the groups on day 5 (P > 0.05), whereas a significant difference was seen on days 10 and 15 post-surgery (P < 0.0001). There was no significant difference between the two groups in terms of post-operative bleeding (P ≅ 1). CONCLUSION We observed that the use of AM graft as a biologic dressing might be beneficial in reducing post-operative pain and promoting the wound healing process. The results represent a further step toward developing a new technique for coverage of tonsillar fossa with sheeting or wearing grafts.",2020,"With respect to the healing rate, there were no significant differences between the groups on day 5 (P > 0.05), whereas a significant difference was seen on days 10 and 15 post-surgery (P < 0.0001).",['60 adult patients who underwent tonsillectomy'],"['amniotic membrane', 'control and amniotic membrane (AM']","['healing rate', 'pain score', 'post-operative bleeding']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0040423', 'cui_str': 'Tonsillectomy'}]","[{'cui': 'C0002630', 'cui_str': 'Structure of amnion'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}]",60.0,0.0159014,"With respect to the healing rate, there were no significant differences between the groups on day 5 (P > 0.05), whereas a significant difference was seen on days 10 and 15 post-surgery (P < 0.0001).","[{'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Faramarzi', 'Affiliation': 'Department of Otolaryngology Head and Neck Surgery, Otolaryngology Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Mahmood', 'Initials': 'M', 'LastName': 'Shishegar', 'Affiliation': 'Department of Otolaryngology Head and Neck Surgery, Otolaryngology Research Center, Shiraz University of Medical Sciences, Shiraz, Iran. shishehgar@sums.ac.ir.'}, {'ForeName': 'Tayebeh', 'Initials': 'T', 'LastName': 'Kazemi', 'Affiliation': 'Department of Otolaryngology Head and Neck Surgery, Otolaryngology Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Hamid', 'Initials': 'H', 'LastName': 'Tavakolpour Saleh', 'Affiliation': 'Department of Otolaryngology Head and Neck Surgery, Otolaryngology Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Sareh', 'Initials': 'S', 'LastName': 'Roosta', 'Affiliation': 'Department of Otolaryngology Head and Neck Surgery, Otolaryngology Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}]",European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery,['10.1007/s00405-020-06173-7'] 2258,32601955,"Effect of Multi-strain Probiotic Formulation on Students Facing Examination Stress: a Double-Blind, Placebo-Controlled Study.","In this placebo-controlled, double-blind clinical trial, we have investigated the effect of multi-strain probiotic (Bacillus coagulans Unique IS2, Lactobacillus rhamnosus UBLR58, Bifidobacterium lactis UBBLa70, Lactobacillus plantarum UBLP40 (each of 2 billion CFU); Bifidobacterium breve UBBr01, Bifidobacterium infantis UBBI01 (each of 1 billion CFU)) capsule with glutamine (250 mg) on students facing examination stress. A total of 80 students (18-24 years) were enrolled and randomised to receive multi-strain probiotic or placebo capsules twice a day for 28 days (i.e. pre- and during examination). The stress was analysed at the baseline and the end of the treatment by using the perceived stress scale (PSS), depression anxiety stress scale (DASS), and state-trait anxiety inventory (STAI) questionnaire. The serum cortisol levels were also determined. As a result, at the end of the trial, a total of 74 students completed the study, and those who consumed probiotic capsules showed a significant reduction in PSS, DASS, and STAI scores, and serum cortisol levels from the baseline as compared with placebo. No adverse events were reported during the study. In conclusion, the multi-strain probiotic is effective in reducing stress associated with examination. CTRI/2019/03/018178.",2020,No adverse events were reported during the study.,"['80 students (18-24\xa0years', 'Students Facing Examination Stress', 'students facing examination stress']","['Placebo', 'Multi-strain Probiotic Formulation', 'multi-strain probiotic (Bacillus coagulans Unique IS2, Lactobacillus rhamnosus UBLR58, Bifidobacterium lactis UBBLa70, Lactobacillus plantarum UBLP40', 'glutamine', 'multi-strain probiotic or placebo', 'placebo']","['perceived stress scale (PSS), depression anxiety stress scale (DASS), and state-trait anxiety inventory (STAI) questionnaire', 'serum cortisol levels', 'adverse events', 'PSS, DASS, and STAI scores, and serum cortisol levels']","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0038435', 'cui_str': 'Stress'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C0004587', 'cui_str': 'Bacillus'}, {'cui': 'C0314931', 'cui_str': 'Bacteroides coagulans'}, {'cui': 'C0317597', 'cui_str': 'Lactobacillus casei rhamnosus'}, {'cui': 'C1001866', 'cui_str': 'Bifidobacterium animalis'}, {'cui': 'C0317608', 'cui_str': 'Lactobacillus plantarum'}, {'cui': 'C0017797', 'cui_str': 'Glutamine'}]","[{'cui': 'C0582653', 'cui_str': 'Perceived stress scale'}, {'cui': 'C0338908', 'cui_str': 'Mixed anxiety and depressive disorder'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0683457', 'cui_str': 'State-trait anger expression inventory'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0236396', 'cui_str': 'Serum cortisol measurement'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1832594', 'cui_str': 'Verloes Bourguignon syndrome'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",74.0,0.204877,No adverse events were reported during the study.,"[{'ForeName': 'Rajesh', 'Initials': 'R', 'LastName': 'Venkataraman', 'Affiliation': 'Department of Pharmacy Practice, Sri Adichunchanagiri College of Pharmacy, Adichunchanagiri University, Mandya, Karnataka, 571448, India.'}, {'ForeName': 'Ratna Sudha', 'Initials': 'RS', 'LastName': 'Madempudi', 'Affiliation': 'Centre for Research and Development, Unique Biotech Ltd., Plot No. 2, Phase II, Alexandria Knowledge Park, Hyderabad, Telangana, 500078, India.'}, {'ForeName': 'Jayanthi', 'Initials': 'J', 'LastName': 'Neelamraju', 'Affiliation': 'Centre for Research and Development, Unique Biotech Ltd., Plot No. 2, Phase II, Alexandria Knowledge Park, Hyderabad, Telangana, 500078, India.'}, {'ForeName': 'Jayesh J', 'Initials': 'JJ', 'LastName': 'Ahire', 'Affiliation': 'Centre for Research and Development, Unique Biotech Ltd., Plot No. 2, Phase II, Alexandria Knowledge Park, Hyderabad, Telangana, 500078, India. jayesh@uniquebiotech.com.'}, {'ForeName': 'H R', 'Initials': 'HR', 'LastName': 'Vinay', 'Affiliation': 'Adichunchanagiri Hospital and Research Centre, Adichunchanagiri University, Mandya, Karnataka, 571448, India.'}, {'ForeName': 'Anila', 'Initials': 'A', 'LastName': 'Lal', 'Affiliation': 'Department of Pharmacy Practice, Sri Adichunchanagiri College of Pharmacy, Adichunchanagiri University, Mandya, Karnataka, 571448, India.'}, {'ForeName': 'Glory', 'Initials': 'G', 'LastName': 'Thomas', 'Affiliation': 'Department of Pharmacy Practice, Sri Adichunchanagiri College of Pharmacy, Adichunchanagiri University, Mandya, Karnataka, 571448, India.'}, {'ForeName': 'Stephy', 'Initials': 'S', 'LastName': 'Stephen', 'Affiliation': 'Department of Pharmacy Practice, Sri Adichunchanagiri College of Pharmacy, Adichunchanagiri University, Mandya, Karnataka, 571448, India.'}]",Probiotics and antimicrobial proteins,['10.1007/s12602-020-09681-4'] 2259,32601973,Evaluation of the effect of N-acetylcysteine on the prevention and amelioration of paclitaxel-induced peripheral neuropathy in breast cancer patients: a randomized controlled study.,"PURPOSE The aim of the current study was to evaluate the effect of N-acetylcysteine (NAC) on the incidence and severity of paclitaxel-induced peripheral neuropathy (PIPN) in breast cancer patients. METHOD A prospective randomized controlled open label study was conducted on 75 breast cancer patients receiving adjuvant paclitaxel 80 mg/m 2 weekly for 12 weeks. Eligible patients were randomized to either the low dose group; 1200 mg daily NAC, the high dose group; 1200 mg NAC twice daily or the control group; received paclitaxel only. The primary endpoint was the incidence of different grades of PIPN using National Cancer Institute's common toxicity criteria for adverse event (NCI-CTCAE) while secondary endpoints were the severity of PIPN using modified total neuropathy score (mTNS), quality of life (QOL) using Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT-GOG-NTX) subscale, serum nerve growth factor (NGF), and serum malondialdehyde (MDA). RESULTS At the end of the 12-week period, the incidence of grade (2, 3) peripheral neuropathy was significantly lower in the high dose group (28.6%) compared to the low dose group (61.9%) and the control group (100%), p value < 0.001. A significant improvement in the mTNS and QOL scores was observed after 6 and 12 weeks in the high dose group and the low dose group compared to the control, p value < 0.001. Significantly higher levels of serum NGF in the high dose group and lower level of serum MDA in the high dose and the low dose group were observed. CONCLUSION Oral NAC (1200 mg once and twice daily) might reduce the incidence and severity of PIPN and improve the patients' QOL. TRIAL REGISTRY Clinical Trial.gov registration number: NCT03492047.",2020,"Significantly higher levels of serum NGF in the high dose group and lower level of serum MDA in the high dose and the low dose group were observed. ","['breast cancer patients', '75 breast cancer patients receiving', 'Eligible patients', '80\xa0mg/m 2 weekly for 12\xa0weeks']","['N-acetylcysteine (NAC', 'adjuvant paclitaxel', 'Oral NAC', 'low dose group; 1200\xa0mg daily NAC, the high dose group; 1200\xa0mg NAC twice daily or the control group; received paclitaxel only', 'N-acetylcysteine']","['serum NGF', 'mTNS and QOL scores', ""incidence and severity of PIPN and improve the patients' QOL"", 'severity of PIPN using modified total neuropathy score (mTNS), quality of life (QOL) using Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity', 'incidence of grade (2, 3) peripheral neuropathy', 'FACT-GOG-NTX) subscale, serum nerve growth factor (NGF), and serum malondialdehyde (MDA', 'level of serum MDA', ""incidence of different grades of PIPN using National Cancer Institute's common toxicity criteria for adverse event (NCI-CTCAE""]","[{'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0001047', 'cui_str': 'Acetylcysteine'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517548', 'cui_str': '1200'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0027752', 'cui_str': 'Nerve Growth Factor'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C1869037', 'cui_str': 'Peripheral neuropathy (SMQ)'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C4727882', 'cui_str': 'Total neuropathy score'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1321164', 'cui_str': 'Gynecological oncology'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0235032', 'cui_str': 'Neurotoxicity'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0285526', 'cui_str': 'N-telopeptide'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0000379', 'cui_str': 'Methylenedioxyamphetamine'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C1513882', 'cui_str': 'National Cancer Institute'}, {'cui': 'C1516728', 'cui_str': 'National Cancer Institute common terminology criteria for adverse events'}, {'cui': 'C0560007', 'cui_str': 'nCi'}]",75.0,0.0327264,"Significantly higher levels of serum NGF in the high dose group and lower level of serum MDA in the high dose and the low dose group were observed. ","[{'ForeName': 'Hadeer G', 'Initials': 'HG', 'LastName': 'Khalefa', 'Affiliation': 'Oncology Clinical Pharmacy Department, Nasser Institute for Research and Treatment, Cairo, Egypt.'}, {'ForeName': 'May A', 'Initials': 'MA', 'LastName': 'Shawki', 'Affiliation': 'Clinical Pharmacy Department, Faculty of Pharmacy, Ain Shams University, Cairo, Egypt. mayahmed@pharma.asu.edu.eg.'}, {'ForeName': 'Rasha', 'Initials': 'R', 'LastName': 'Aboelhassan', 'Affiliation': 'Nasser Institute for Research and Treatment, Cairo, Egypt.'}, {'ForeName': 'Lamia M', 'Initials': 'LM', 'LastName': 'El Wakeel', 'Affiliation': 'Clinical Pharmacy Department, Faculty of Pharmacy, Ain Shams University, Cairo, Egypt.'}]",Breast cancer research and treatment,['10.1007/s10549-020-05762-8'] 2260,29782218,Postural control and physiological responses to a simulated match in U-20 judo competitors.,"The aim was to evaluate the effects of judo combat on the athletes' postural control (PC) and physiological loading before, during and after a simulated match. Seventeen under-20 regional and national level athletes completed one modified 7-min match. At baseline, during the combat (3rd and 7th minutes) and 2-min post-match centre of pressure (CoP) parameters were assessed. Heart rate (HR), blood lactate (BLa) and rating of perceived exertion (RPE) and local RPE (LRPE) were collected. Significant increments were observed in CoP mean positioning and velocity at 3rd and 7th minutes, but the CoP deviation in both axes was unaffected. HR and BLa were elevated at 3rd and 7th minutes, and they remained elevated 2-min post-match. However, CoP returned to baseline 2-min post-match. RPE was elevated at 3rd and 7th minutes and the greatest effort was displayed in the Deltoid and Quadriceps. Thus, one simulated judo match stimulates a significant metabolic response and balance is degraded, with the greatest effects on the anterior-posterior axis and it recovers to baseline level after 2 min of passive rest. The physiological load cannot be regarded as a potential predictor variable of CoP. Overall, a judo match predominantly affects the upper body than the other body parts.",2020,"Heart rate (HR), blood lactate (BLa) and rating of perceived exertion (RPE) and local RPE (LRPE) were collected.","['Seventeen under-20 regional and national level athletes completed one modified 7-min match', 'U-20 judo competitors']",[],"['HR and BLa', 'Heart rate (HR), blood lactate (BLa) and rating of perceived exertion (RPE) and local RPE (LRPE', 'RPE', 'CoP mean positioning and velocity']","[{'cui': 'C0450331', 'cui_str': '17'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0079650', 'cui_str': 'Judo'}]",[],"[{'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0035322', 'cui_str': 'Structure of retinal pigment epithelium'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0445074', 'cui_str': 'Mean pressure'}, {'cui': 'C0150305', 'cui_str': 'Positioning - therapy'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}]",,0.0247848,"Heart rate (HR), blood lactate (BLa) and rating of perceived exertion (RPE) and local RPE (LRPE) were collected.","[{'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Santos', 'Affiliation': 'Faculty of Physical Activity and Sport Sciences, University of León, León, Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Fernández-Río', 'Affiliation': 'Faculty of Physical Activity and Sport Sciences, University of León, León, Spain.'}, {'ForeName': 'Eliseo', 'Initials': 'E', 'LastName': 'Iglesias-Soler', 'Affiliation': 'Faculty of Sports Sciences and Physical Education, Performance and Health Group, Department of Physical Education and Sport, University of A Coruna, A Coruña, Spain.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Blanco-Traba', 'Affiliation': 'Catholic University of Valencia, Valencia, Spain.'}, {'ForeName': 'Markus Due', 'Initials': 'MD', 'LastName': 'Jakobsen', 'Affiliation': 'National Research Centre for the Working Environment, Copenhagen, Denmark.'}, {'ForeName': 'Vicente', 'Initials': 'V', 'LastName': 'González-Díez', 'Affiliation': 'Medical Service of the Community of Cabo Peñas, Asturias, Spain.'}, {'ForeName': 'Emerson', 'Initials': 'E', 'LastName': 'Franchini', 'Affiliation': 'School of Physical Education and Sport, University of São Paulo, São Paulo, Brazil.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Gutiérrez', 'Affiliation': 'Faculty of Physical Activity and Sport Sciences, University of León, León, Spain.'}, {'ForeName': 'Xurxo', 'Initials': 'X', 'LastName': 'Dopico-Calvo', 'Affiliation': 'Faculty of Sports Sciences and Physical Education, Performance and Health Group, Department of Physical Education and Sport, University of A Coruna, A Coruña, Spain.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Carballeira-Fernández', 'Affiliation': 'Faculty of Sports Sciences and Physical Education, Performance and Health Group, Department of Physical Education and Sport, University of A Coruna, A Coruña, Spain.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Amonette', 'Affiliation': 'Human Performance Laboratory, University of Houston-Clear Lake, Houston, TX, USA.'}, {'ForeName': 'Oscar', 'Initials': 'O', 'LastName': 'Suman', 'Affiliation': 'Department of Surgery, University of Texas Medical Branch, Galveston, TX, USA.'}]",Sports biomechanics,['10.1080/14763141.2018.1461237'] 2261,30431649,The Alliance and Rupture Observation Scale (AROS): Development and validation of an alliance and rupture measure for repeated observations within psychotherapy sessions.,"OBJECTIVE The aim of this study was to test a new observer-rated instrument, the Alliance and Rupture Observation Scale (AROS). It was designed for repeated measurements of the alliance within sessions and to detect alliance ruptures. METHOD Videotaped therapy sessions with depressed adults were analyzed. Reliability was mainly assessed as inter-rater reliability. Convergent, predictive, and discriminant validity of the AROS was assessed by comparing the instrument with both observer-rated and patient-rated measures. RESULTS The AROS exhibited excellent inter-rater reliability. Alliance levels measured with the AROS predicted patients' ratings of the alliance in the same session and were highly correlated with another observer-rated alliance measure. Alliance patterns (rupture; repair; and no-rupture) based on AROS scores were significantly correlated with patients' ratings of the alliance. CONCLUSIONS Preliminary support for convergent and predictive validity was found. It is yet to be determined whether AROS scores are related to psychotherapy outcomes.",2019,"Alliance patterns (rupture; repair; and no-rupture) based on AROS scores were significantly correlated with patients' ratings of the alliance. ",[],[],"['Reliability', 'Alliance levels', 'AROS scores', 'AROS exhibited excellent inter-rater reliability', 'Alliance and Rupture Observation Scale (AROS): Development and validation of an alliance and rupture measure', 'Alliance and Rupture Observation Scale (AROS']",[],[],"[{'cui': 'C0035035', 'cui_str': 'Reliability (Epidemiology)'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0443294', 'cui_str': 'Ruptured'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0015272', 'cui_str': 'Exhibits as Topic'}, {'cui': 'C1961136', 'cui_str': 'Excellent'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",,0.0322022,"Alliance patterns (rupture; repair; and no-rupture) based on AROS scores were significantly correlated with patients' ratings of the alliance. ","[{'ForeName': 'Mattias Holmqvist', 'Initials': 'MH', 'LastName': 'Larsson', 'Affiliation': 'Department of Behavioral Sciences and Learning, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Björkman', 'Affiliation': 'Department of Behavioral Sciences and Learning, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Nilsson', 'Affiliation': 'Department of Behavioral Sciences and Learning, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Fredrik', 'Initials': 'F', 'LastName': 'Falkenström', 'Affiliation': 'Department of Behavioral Sciences and Learning, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Rolf', 'Initials': 'R', 'LastName': 'Holmqvist', 'Affiliation': 'Department of Behavioral Sciences and Learning, Linköping University, Linköping, Sweden.'}]",Journal of clinical psychology,['10.1002/jclp.22704'] 2262,31182293,Do the holidays impact weight and self-weighing behaviour among adults engaged in a behavioural weight loss intervention?,"We examined the U.S. holiday period impact on weight gain, self-weighing, and treatment success among adults in a weight loss intervention (N=171). Using electronic scales, body weight and self-weighing frequency were compared by time period [i.e., pre-holiday, holiday (November 15-January 1), post-holiday]. Self-weighing was less frequent during holiday period (p<.01), and longer intervention engagement was associated with weight gain (p<.0001) during this time. Enrollment during holiday period was associated with 2.3% 12-month weight loss. Holiday period enrollment might be beneficial for preventing holiday weight gain and facilitating successful intervention outcomes.",2019,"Self-weighing was less frequent during holiday period (p<.01), and longer intervention engagement was associated with weight gain (p<.0001) during this time.",['adults in a weight loss intervention (N=171'],[],"['weight gain', 'weight gain, self-weighing, and treatment success', 'holiday weight gain', 'Self-weighing', 'electronic scales, body weight and self-weighing frequency']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],"[{'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0019843', 'cui_str': 'Holidays'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}]",,0.0204849,"Self-weighing was less frequent during holiday period (p<.01), and longer intervention engagement was associated with weight gain (p<.0001) during this time.","[{'ForeName': 'Margaret C', 'Initials': 'MC', 'LastName': 'Fahey', 'Affiliation': 'The University of Memphis, Department of Psychology, 400 Innovation Drive Memphis, TN, 38111, USA. Electronic address: mcfahey@memphis.edu.'}, {'ForeName': 'Robert C', 'Initials': 'RC', 'LastName': 'Klesges', 'Affiliation': 'Department of Preventive Medicine, University of Tennessee Health Science Center, 66 N Pauline Street Memphis, TN, 38105, USA; University of Virginia, Department of Public Health Sciences, School of Medicine, 1215 Lee Street, Charlottesville, VA, 22908, USA.'}, {'ForeName': 'Mehmet', 'Initials': 'M', 'LastName': 'Kocak', 'Affiliation': 'Department of Preventive Medicine, University of Tennessee Health Science Center, 66 N Pauline Street Memphis, TN, 38105, USA.'}, {'ForeName': 'Jiajing', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Preventive Medicine, University of Tennessee Health Science Center, 66 N Pauline Street Memphis, TN, 38105, USA.'}, {'ForeName': 'Gerald W', 'Initials': 'GW', 'LastName': 'Talcott', 'Affiliation': 'Department of Preventive Medicine, University of Tennessee Health Science Center, 66 N Pauline Street Memphis, TN, 38105, USA; University of Virginia, Department of Public Health Sciences, School of Medicine, 1215 Lee Street, Charlottesville, VA, 22908, USA.'}, {'ForeName': 'Rebecca A', 'Initials': 'RA', 'LastName': 'Krukowski', 'Affiliation': 'Department of Preventive Medicine, University of Tennessee Health Science Center, 66 N Pauline Street Memphis, TN, 38105, USA.'}]",Obesity research & clinical practice,['10.1016/j.orcp.2019.05.001'] 2263,31283865,Quetiapine extended-release vs olanzapine for Japanese patients with bipolar depression: A Bayesian analysis.,"OBJECTIVE It is unknown whether there are differences in efficacy and safety between quetiapine extended-release, 300 mg/d (QUEXR300), and olanzapine, 5-20 mg/d (OLA), for Japanese patients with bipolar depression. METHODS We conducted a Bayesian analysis of data from phase 3 studies in Japan of QUEXR300 and OLA. Outcomes were remission rate (primary), response rate, improvement on the Montgomery-Åsberg Depression Rating Scale and 17-item Hamilton Depression Rating Scale scores, discontinuation rate, and incidence of individual adverse events. We calculated the standardized mean difference (SMD) and the risk ratio (RR) and 95% credible interval (95% CrI) for continuous and dichotomous data, respectively. RESULTS There were no significant differences between QUEXR300 and OLA for any of the efficacy outcomes. QUEXR300 was associated with a higher incidence of somnolence than OLA (RR = 5.517; 95% CrI = 1.563, 19.787), while OLA was associated with greater increase body weight (SMD = -0.488; 95% CrI = -0.881, -0.089) and blood prolactin levels (SMD = -0.642; 95% CrI = -1.073, -0.213) than QUEXR300, and a greater decrease in high-density lipoprotein cholesterol levels (SMD = -0.408; 95% CrI = -0.785, -0.030) than QUEXR300. CONCLUSION Although the two drugs' efficacy did not differ, OLA increased the risk of metabolic syndrome and QUEXR300 the risk of somnolence. A large scale, long-term, head-to-head comparison study of QUEXR300 vs OLA for Japanese patients with bipolar depression is needed to confirm the results of the current study.",2019,"QUEXR300 was associated with a higher incidence of somnolence than OLA (RR = 5.517; 95% CrI = 1.563, 19.787), while OLA was associated with greater increase body weight (SMD = -0.488; 95% CrI = -0.881, -0.089) and blood prolactin levels (SMD = -0.642; 95% CrI = -1.073, -0.213) than QUEXR300, and a greater decrease in high-density lipoprotein cholesterol levels (SMD = -0.408; 95% CrI = -0.785, -0.030) than QUEXR300. ",['Japanese patients with bipolar depression'],"['olanzapine', 'OLA', 'QUEXR300 vs OLA', 'Quetiapine', 'quetiapine']","['remission rate (primary), response rate, improvement on the Montgomery-Åsberg Depression Rating Scale and 17-item Hamilton Depression Rating Scale scores, discontinuation rate, and incidence of individual adverse events', 'standardized mean difference (SMD) and the risk ratio (RR', 'body weight', 'blood prolactin levels', 'high-density lipoprotein cholesterol levels', 'efficacy and safety']","[{'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0005587', 'cui_str': 'Bipolar affective disorder, current episode depression'}]","[{'cui': 'C0171023', 'cui_str': 'olanzapine'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0123091', 'cui_str': 'quetiapine'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C4319604', 'cui_str': '300'}]","[{'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C2960593', 'cui_str': 'Montgomery-Åsberg depression rating scale'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0028873', 'cui_str': 'Cross-Product Ratio'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0853129', 'cui_str': 'Blood prolactin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0392885', 'cui_str': 'High density lipoprotein measurement'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.0420709,"QUEXR300 was associated with a higher incidence of somnolence than OLA (RR = 5.517; 95% CrI = 1.563, 19.787), while OLA was associated with greater increase body weight (SMD = -0.488; 95% CrI = -0.881, -0.089) and blood prolactin levels (SMD = -0.642; 95% CrI = -1.073, -0.213) than QUEXR300, and a greater decrease in high-density lipoprotein cholesterol levels (SMD = -0.408; 95% CrI = -0.785, -0.030) than QUEXR300. ","[{'ForeName': 'Taro', 'Initials': 'T', 'LastName': 'Kishi', 'Affiliation': 'Department of Psychiatry, Fujita Health University School of Medicine, Toyoake, Aichi, Japan.'}, {'ForeName': 'Toshikazu', 'Initials': 'T', 'LastName': 'Ikuta', 'Affiliation': 'Department of Communication Sciences and Disorders, Digital Neuroscience Laboratory, The University of Mississippi, University Park, Mississippi, USA.'}, {'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Matsuda', 'Affiliation': 'Department of Psychiatry, Jikei University School of Medicine, Minato-ku, Tokyo, Japan.'}, {'ForeName': 'Nakao', 'Initials': 'N', 'LastName': 'Iwata', 'Affiliation': 'Department of Psychiatry, Fujita Health University School of Medicine, Toyoake, Aichi, Japan.'}]",Neuropsychopharmacology reports,['10.1002/npr2.12070'] 2264,31307925,Nonalcoholic fatty liver disease does not predict worse perioperative outcomes in bariatric surgery.,"Nonalcoholic fatty liver disease (NAFLD) occurs in 84-95% of obese individuals. Bariatric surgery (BS) is an effective treatment of obesity, with a potential sustained weight loss of 21-45%. The safety and efficacy of BS among NAFLD patients is not well established. The aim of this study was to determine outcomes for patients with NAFLD undergoing BS compared to patients without. METHODS All adults undergoing BS were identified from the National Inpatient Sample 2012-2015 and stratified based on the presence of NAFLD using ICD-9/CPT codes. Primary outcomes included inpatient mortality, length of stay (LOS), and total hospital charges (THC). Secondary outcomes included infection, bleeding, improper wound healing and surgical revision. RESULTS 302,306 patients underwent BS, of which 15,607 had NAFLD and 286,699 did not (non-NAFLD). NAFLD patients had 35% lower inpatient mortality and shorter LOS, but slightly greater THC. NAFLD patients had smaller risk of improper wound healing and post-operative infection. There was no difference in bleeding, or incidence of surgical revision between groups. CONCLUSION NAFLD patients had lower mortality and complication rates following BS. A significant postsurgical weight loss should attenuate liver inflammation and fibrosis, and therefore has the potential to stop or even reverse progression of liver disease.",2019,"There was no difference in bleeding, or incidence of surgical revision between groups. ","['patients with NAFLD undergoing BS compared to patients without', '302,306 patients underwent BS, of which 15,607 had NAFLD and 286,699 did not (non-NAFLD', 'All adults undergoing BS were identified from the National Inpatient Sample 2012-2015 and stratified based on the presence of NAFLD using ICD-9/CPT codes', '84-95% of obese individuals']","['NAFLD', 'Bariatric surgery (BS']","['THC', 'bleeding, or incidence of surgical revision', 'mortality and complication rates', 'inpatient mortality, length of stay (LOS), and total hospital charges (THC', 'infection, bleeding, improper wound healing and surgical revision', 'smaller risk of improper wound healing and post-operative infection', 'safety and efficacy of BS', 'inpatient mortality and shorter LOS', 'Nonalcoholic fatty liver disease (NAFLD']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C1456587', 'cui_str': 'Metabolic surgery'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0020725', 'cui_str': 'I-cell disease'}, {'cui': 'C0009219', 'cui_str': 'Coding'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C1456587', 'cui_str': 'Metabolic surgery'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0206175', 'cui_str': 'Charge, Hospital'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0035110', 'cui_str': 'Reoperation'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C1456587', 'cui_str': 'Metabolic surgery'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}]",302306.0,0.0695181,"There was no difference in bleeding, or incidence of surgical revision between groups. ","[{'ForeName': 'Marianna G', 'Initials': 'MG', 'LastName': 'Mavilia', 'Affiliation': 'Department of Medicine, University of Connecticut, Farmington CT, United States; Department of Medicine, St. Francis Hospital and Medical Center, Hartford CT, United States. Electronic address: mmavilia@uchc.edu.'}, {'ForeName': 'Dorothy', 'Initials': 'D', 'LastName': 'Wakefield', 'Affiliation': 'Center on Aging, University of Connecticut Health Center, Farmington CT, United States.'}, {'ForeName': 'Raffi', 'Initials': 'R', 'LastName': 'Karagozian', 'Affiliation': 'Department of Gastroenterology and Hepatology, Tufts Medical Center, Boston MA, United States.'}]",Obesity research & clinical practice,['10.1016/j.orcp.2019.06.006'] 2265,32602347,Machine-Learning Algorithms Based on Screening Tests for Mild Cognitive Impairment.,"BACKGROUND The mobile screening test system for mild cognitive impairment (mSTS-MCI) was developed and validated to address the low sensitivity and specificity of the Montreal Cognitive Assessment (MoCA) widely used clinically. OBJECTIVE This study was to evaluate the efficacy machine learning algorithms based on the mSTS-MCI and Korean version of MoCA. METHOD In total, 103 healthy individuals and 74 patients with MCI were randomly divided into training and test data sets, respectively. The algorithm using TensorFlow was trained based on the training data set, and then its accuracy was calculated based on the test data set. The cost was calculated via logistic regression in this case. RESULT Predictive power of the algorithms was higher than those of the original tests. In particular, the algorithm based on the mSTS-MCI showed the highest positive-predictive value. CONCLUSION The machine learning algorithms predicting MCI showed the comparable findings with the conventional screening tools.",2020,Predictive power of the algorithms was higher than those of the original tests.,"['103 healthy individuals and 74 patients with MCI', 'Mild Cognitive Impairment', 'mild cognitive impairment (mSTS-MCI']",['Machine-Learning Algorithms'],[],"[{'cui': 'C4517526', 'cui_str': '103'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0560005', 'cui_str': 'mCi'}, {'cui': 'C1270972', 'cui_str': 'Mild cognitive disorder'}, {'cui': 'C0871311', 'cui_str': 'Screening test'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0336779', 'cui_str': 'Machine'}, {'cui': 'C0023185', 'cui_str': 'Learning'}]",[],103.0,0.0155207,Predictive power of the algorithms was higher than those of the original tests.,"[{'ForeName': 'Jin-Hyuck', 'Initials': 'JH', 'LastName': 'Park', 'Affiliation': 'Department of Occupational Therapy, College of Medical Science, Soonchunhyang University, Asan, Korea.'}]",American journal of Alzheimer's disease and other dementias,['10.1177/1533317520927163'] 2266,32602362,Efficacy of an innovative smartphone application for office workers with chronic non-specific low back pain: a pilot randomized controlled trial.,"OBJECTIVE To evaluate the efficacy of a newly developed evidence-based low back pain (LBP) management smartphone application. DESIGN A double-blinded randomized controlled trial where participants randomly assigned to either an experimental group (EG) or a control group (CG). SETTING Governmental and private institutions. PARTICIPANTS About 40 office workers, aged 30 to 55 years, had pain due to non-specific LBP > 3 on Visual Analogue Scale, and with pain chronicity > 3 months. INTERVENTIONS The EG received full version of the application 'Relieve my back' included evidence-based instructions and therapeutic exercises for LBP management, whereas the CG received placebo version included instructions about nutrition. MAIN MEASURES Primary outcome measures included pain measured by Visual Analogue Scale (VAS), disability measured by Oswestry Disability Index (ODI), and quality of life measured by Short-Form Health Survey (SF-12). RESULTS Following six weeks of using the application, compared to CG, the EG group demonstrated significant decrease in pain intensity (-3.45 (2.21) vs -0.11 (1.66), P  < 0.001), in ODI score (-11.05 (10.40) vs -0.58 (9.0), P  = 0.002), and significant increase in physical component of SF-12 (12.85 (17.20) vs -4.63 (12.04), P  = 0.001). CONCLUSION 'Relieve my back' application might be efficacious in reducing pain and disability and improving the quality of life of office workers with non-specific LBP.",2020,Relieve my back' application might be efficacious in reducing pain and disability and improving the quality of life of office workers with non-specific LBP.,"['Governmental and private institutions', 'office workers with chronic non-specific low back pain', 'About 40 office workers, aged 30 to 55\u2009years, had pain due to non-specific LBP\u2009>\u20093 on Visual Analogue Scale, and with pain chronicity\u2009>\u20093\u2009months']","['control group (CG', 'placebo version included instructions about nutrition', 'innovative smartphone application']","['physical component of SF-12', 'pain and disability', 'pain intensity', 'ODI score', 'pain measured by Visual Analogue Scale (VAS), disability measured by Oswestry Disability Index (ODI), and quality of life measured by Short-Form Health Survey (SF-12']","[{'cui': 'C0033175', 'cui_str': 'Private Room'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0205370', 'cui_str': 'Non-specific'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0547045', 'cui_str': 'Chronicity'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0185125', 'cui_str': 'Application'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C2960603', 'cui_str': 'Oswestry disability index score'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}]",,0.214839,Relieve my back' application might be efficacious in reducing pain and disability and improving the quality of life of office workers with non-specific LBP.,"[{'ForeName': 'Khader A', 'Initials': 'KA', 'LastName': 'Almhdawi', 'Affiliation': 'Department of Rehabilitation Science, Jordan University of Science and Technology, Irbid, Jordan.'}, {'ForeName': 'Donia Saleh', 'Initials': 'DS', 'LastName': 'Obeidat', 'Affiliation': 'Department of Rehabilitation Science, Jordan University of Science and Technology, Irbid, Jordan.'}, {'ForeName': 'Saddam F', 'Initials': 'SF', 'LastName': 'Kanaan', 'Affiliation': 'Department of Rehabilitation Science, Jordan University of Science and Technology, Irbid, Jordan.'}, {'ForeName': 'Alaa O', 'Initials': 'AO', 'LastName': 'Oteir', 'Affiliation': 'Department of Allied Medical Science, Jordan University of Science and Technology, Irbid, Jordan.'}, {'ForeName': 'Zaid Modhi', 'Initials': 'ZM', 'LastName': 'Mansour', 'Affiliation': 'Department of Physical and Occupational Therapy, The Hashemite University, Zarqa, Jordan.'}, {'ForeName': 'Hassan', 'Initials': 'H', 'LastName': 'Alrabbaei', 'Affiliation': 'Department of Rehabilitation Science, Jordan University of Science and Technology, Irbid, Jordan.'}]",Clinical rehabilitation,['10.1177/0269215520937757'] 2267,32602373,The effects of small-needle-knife therapy on pain and mobility from knee osteoarthritis: a pilot randomized-controlled study.,"OBJECTIVE To investigate the effect of small needle-knife therapy in people with painful knee osteoarthritis. DESIGN Pilot randomised, controlled trial. SETTING Rehabilitation hospital. SUBJECTS In-patients with osteo-arthritis of the knee. INTERVENTIONS Either 1 to 3 small needle-knife treatments over seven days or oral Celecoxib. All patients stayed in hospital three weeks, receiving the same mobility-focused rehabilitation. MEASURES Oxford Knee Score (OKS), gait speed and kinematics were recorded at baseline, at three weeks (discharge) and at three-months (OKS only). Withdrawal from the study, and adverse events associated with the small needle knife therapy were recorded. RESULTS 83 patients were randomized: 44 into the control group, of whom 10 were lost by three weeks and 12 at 3 months; 39 into the experimental group of whom eight were lost at three weeks and three months. The mean (SE) OKS scores at baseline were Control 35.86 (1.05), Exp 38.38 (0.99); at three weeks 26.64 (0.97) and 21.94 (1.23); and at three months 25.83 (0.91) and 20.48 (1.14) The mean (SE) gait speed at baseline was 1.07 (0.03) m/sec (Control) and 0.98 (0.03), and at three weeks was 1.14 (0.03) and 1.12 (0.03) ( P < 0.05). Linear mixed model statistical analysis showed that the improvements in the experimental group were statistically significant for total OKS score at discharge and three months. CONCLUSIONS Small needle-knife therapy added to standard therapy for patients with knee osteoarthritis, was acceptable, safe and reduced pain and improved global function on the Oxford Knee Score. Further research is warranted.",2020,"Linear mixed model statistical analysis showed that the improvements in the experimental group were statistically significant for total OKS score at discharge and three months. ","['Rehabilitation hospital', 'people with painful knee osteoarthritis', 'In-patients with osteo-arthritis of the knee', 'knee osteoarthritis', '83 patients', 'patients with knee osteoarthritis']","['small needle-knife therapy', 'small needle knife therapy', 'Celecoxib', 'small-needle-knife therapy', 'Small needle-knife therapy']","['pain and mobility', 'Oxford Knee Score (OKS), gait speed and kinematics', 'mean (SE) OKS scores', 'total OKS score', 'mean (SE) gait speed', 'safe and reduced pain and improved global function']","[{'cui': 'C0337962', 'cui_str': 'Rehabilitation hospital'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0231749', 'cui_str': 'Knee pain'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0240111', 'cui_str': 'Arthritis of knee'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}]","[{'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0181464', 'cui_str': 'Needle knife'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0538927', 'cui_str': 'celecoxib'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C1997265', 'cui_str': 'Oxford knee score'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0600169', 'cui_str': 'Kinematics'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",83.0,0.0422692,"Linear mixed model statistical analysis showed that the improvements in the experimental group were statistically significant for total OKS score at discharge and three months. ","[{'ForeName': 'Junchen', 'Initials': 'J', 'LastName': 'Zhu', 'Affiliation': 'The Department of Orthopaedics, the Second Affiliated Hospital of Anhui University of Chinese Medicine, Hefei, Anhui Province, China.'}, {'ForeName': 'Zhiwen', 'Initials': 'Z', 'LastName': 'Zheng', 'Affiliation': 'The Department of Orthopaedics, the Second Affiliated Hospital of Anhui University of Chinese Medicine, Hefei, Anhui Province, China.'}, {'ForeName': 'Yaomeng', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Centre for Movement and Occupational Rehabilitation Sciences, Faculty of Health and Life Sciences, Oxford Brookes University, Oxford, UK.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Lawrie', 'Affiliation': 'Centre for Movement and Occupational Rehabilitation Sciences, Faculty of Health and Life Sciences, Oxford Brookes University, Oxford, UK.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Esser', 'Affiliation': 'Centre for Movement and Occupational Rehabilitation Sciences, Faculty of Health and Life Sciences, Oxford Brookes University, Oxford, UK.'}, {'ForeName': 'Hooshang', 'Initials': 'H', 'LastName': 'Izadi', 'Affiliation': 'Centre for Movement and Occupational Rehabilitation Sciences, Faculty of Health and Life Sciences, Oxford Brookes University, Oxford, UK.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Dawes', 'Affiliation': 'Centre for Movement and Occupational Rehabilitation Sciences, Faculty of Health and Life Sciences, Oxford Brookes University, Oxford, UK.'}, {'ForeName': 'Zhidao', 'Initials': 'Z', 'LastName': 'Xia', 'Affiliation': 'Centre for Movement and Occupational Rehabilitation Sciences, Faculty of Health and Life Sciences, Oxford Brookes University, Oxford, UK.'}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'The Department of Orthopaedics, the Second Affiliated Hospital of Anhui University of Chinese Medicine, Hefei, Anhui Province, China.'}, {'ForeName': 'Yingzong', 'Initials': 'Y', 'LastName': 'Xiong', 'Affiliation': 'The Department of Orthopaedics, the Second Affiliated Hospital of Anhui University of Chinese Medicine, Hefei, Anhui Province, China.'}, {'ForeName': 'Xingfu', 'Initials': 'X', 'LastName': 'Ma', 'Affiliation': 'The Department of Orthopaedics, the Second Affiliated Hospital of Anhui University of Chinese Medicine, Hefei, Anhui Province, China.'}, {'ForeName': 'Derick T', 'Initials': 'DT', 'LastName': 'Wade', 'Affiliation': 'Centre for Movement and Occupational Rehabilitation Sciences, Faculty of Health and Life Sciences, Oxford Brookes University, Oxford, UK.'}]",Clinical rehabilitation,['10.1177/0269215520938852'] 2268,32602376,Sleep problems worsen health-related quality of life and participation during the first 12 months of stroke rehabilitation.,"OBJECTIVE Evaluate the impact of self-reported sleep problems on post-stroke recovery. DESIGN Cross-sectional secondary analysis of longitudinal data from the Locomotor Experience Applied Post-Stroke (LEAPS) rehabilitation and recovery study (phase-III single-blind randomized controlled clinical trial). Group medians were compared for three sleep problem groups across three time points. SETTING Outpatient and in-home physical therapy. SUBJECTS Adults during the first year following stroke ( n  = 408, 380, 360 at 2, 6, 12 months, respectively). INTERVENTIONS The original study compared effects of locomotor training with body weight support in the year post-stroke. This analysis evaluated function in three sleep/functional-impact groups: no sleep problems, sleep problems with no-to-minimal-impact and sleep problems with moderate-to-quite-a-bit of impact. MAIN MEASURES Participants' responses regarding if they had ""a sleep problem, such as insomnia"" and, if so, what the impact was on their function. Stroke Impact Scale subscales for strength, hand function, mobility, ADLs, memory, communication, emotion, participation, and percent recovery. RESULTS About 25% of people with stroke reported sleep difficulty, 10% perceived sleep problems negatively impact function. Groups self-reporting worse sleep performed worse in all functional subscales (except self-perceived percent recovery) during the first year post-stroke. CONCLUSION Self-reported poor sleep adversely effects post-stroke functional recovery.",2020,"Groups self-reporting worse sleep performed worse in all functional subscales (except self-perceived percent recovery) during the first year post-stroke. ","['Adults during the first year following stroke ( n \u2009=\u2009408, 380, 360 at 2, 6, 12\u2009months, respectively', 'Outpatient and in-home physical therapy']","['locomotor training with body weight support', 'Locomotor Experience Applied Post-Stroke (LEAPS) rehabilitation']","['Stroke Impact Scale subscales for strength, hand function, mobility, ADLs, memory, communication, emotion, participation, and percent recovery']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C4517769', 'cui_str': '408'}, {'cui': 'C4319693', 'cui_str': '380'}, {'cui': 'C4319607', 'cui_str': '360'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}]","[{'cui': 'C0419113', 'cui_str': 'Locomotor training'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}]","[{'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0562230', 'cui_str': 'Hand functions'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0439165', 'cui_str': 'Percent'}]",,0.0806525,"Groups self-reporting worse sleep performed worse in all functional subscales (except self-perceived percent recovery) during the first year post-stroke. ","[{'ForeName': 'George', 'Initials': 'G', 'LastName': 'Fulk', 'Affiliation': 'SUNY Upstate Medical University, Syracuse, NY, USA.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Duncan', 'Affiliation': 'Wake Forest University Health Sciences, Wake Forest, NC, USA.'}, {'ForeName': 'Karen J', 'Initials': 'KJ', 'LastName': 'Klingman', 'Affiliation': 'SUNY Upstate Medical University, Syracuse, NY, USA.'}]",Clinical rehabilitation,['10.1177/0269215520935940'] 2269,32602557,"Prevention of adhesive capsulitis following pacemaker Implementation, A randomized controlled study.","INTRODUCTION Gradual painful loss of active and passive range of motion in shoulder joint was introduced as adhesive capsulitis (AC). Disabilities in patients with AC are absenteeism from work, loss to leisure time and recurrent seeking to health care services. The aim of this study was to evaluate the incidence of AC following pacemaker implementation. Effect of physical therapy and exercise education was also evaluated to prevent AC following pacemaker implementation. METHODS This study is a randomized clinical controlled trial. It was conducted on 62 pacemaker candidates. Patients with no shoulder pain and without any motion limits were enrolled the study consecutively. The patients randomly were divided into two groups after pacemaker implementation. One group treated with physical therapy [group A, n = 28] and the other group didn't [group B, n = 34]. The incidence of adhesive capsulitis was assessed in both groups after 4 months. RESULTS A totall of 62 patients were enrolled in the study. The mean age was 63.2 ± 12.1 years in the group A and 67.1 ± 17.6 years in the group B. Age was not significantly different between groups. A total of 11 patients (17.7%) had adhesive capsulitis 16 weeks after the initial visit [2 in group-A and 9 patients in group-B; P = 0.004]. CONCLUSIONS Incidence of adhesive capsulitis is 17.7% following device implantain. Exercise education and physical therapy significantly reduces adhesive capsulitis incidence following pacemaker implantation. This article is protected by copyright. All rights reserved.",2020,Exercise education and physical therapy significantly reduces adhesive capsulitis incidence following pacemaker implantation.,"['Patients with no shoulder pain and without any motion limits were enrolled the study consecutively', 'pacemaker implantation', '62 patients were enrolled in the study']","['physical therapy and exercise education', 'Exercise education and physical therapy', 'physical therapy']","['incidence of adhesive capsulitis', 'adhesive capsulitis incidence']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037011', 'cui_str': 'Shoulder pain'}, {'cui': 'C0026597', 'cui_str': 'Motion'}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0030163', 'cui_str': 'Cardiac pacemaker'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]","[{'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}, {'cui': 'C0582396', 'cui_str': 'Exercise education'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0158300', 'cui_str': 'Capsulitis, Adhesive'}]",62.0,0.0523918,Exercise education and physical therapy significantly reduces adhesive capsulitis incidence following pacemaker implantation.,"[{'ForeName': 'Mohammad Vahid', 'Initials': 'MV', 'LastName': 'Jorat', 'Affiliation': 'Associate Professor of Cardiology, Interventional Electrophysiologist, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Seyedeh Mahdieh', 'Initials': 'SM', 'LastName': 'Namayandeh', 'Affiliation': 'Epidemiologist, Shahid Sadooghi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'Zahra Mehdipour', 'Initials': 'ZM', 'LastName': 'Namdar', 'Affiliation': 'Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Aslani', 'Affiliation': 'Associate Professor of Cardiology, Interventional Electrophysiologist, Shiraz University of Medical Sciences, Shiraz, Iran.'}]",Pacing and clinical electrophysiology : PACE,['10.1111/pace.13999'] 2270,32602588,Nursing Home Care Intervention Post Stroke (SHARE) 1 year effect on the burden of family caregivers for older adults in Brazil: A randomized controlled trial.,"The purpose of this study is to evaluate the effect of home-care nursing intervention on the burden of family caregivers for older adults surviving a stroke. A randomised clinical trial blinded for outcome evaluation. Forty-eight family caregivers of older adults surviving a stroke took part in the study. The intervention group (IG) received three home visits by nurses in 1 month after hospital discharge for guidance on the disease and care activities for the elderly people. The control group (CG) relied on the service network that had access. The Caregiver Burden Scale was applied to assess the burden outcome 1 week, 60 days and 1 year after hospital discharge. The caregivers of the intervention and CGs had no difference regarding baseline data. There was an interaction effect between the CG and the IG in the isolation domain (p = 0.037) and in the emotional involvement domain (p = 0.003) over time. These findings provide support for strengthening a care line for the elderly people after a stroke, with adequate discharge planning, indicating the importance of integrating care network services such as primary care, home care and hospital care with a view to achieving an effective care transition. It is also necessary to construct a specific instrument to evaluate other outcomes, such as the knowledge and learning of caregivers in relation to the care activities taught. This study is registered in the Clinical Trials with name Nursing Home Care Intervention Post Stroke (SHARE) and under number NCT02807012.",2020,There was an interaction effect between the CG and the IG in the isolation domain (p = 0.037) and in the emotional involvement domain (p = 0.003) over time.,"['Forty-eight family caregivers of older adults surviving a stroke took part in the study', 'older adults surviving a stroke', 'older adults in Brazil']","['intervention group (IG) received three home visits by nurses in 1\xa0month after hospital discharge for guidance on the disease and care activities', 'Nursing Home Care Intervention Post Stroke (SHARE', 'home-care nursing intervention']",['burden of family caregivers'],"[{'cui': 'C4319608', 'cui_str': '48'}, {'cui': 'C0086279', 'cui_str': 'Family Caregivers'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0020043', 'cui_str': 'Home visit'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0586003', 'cui_str': 'Discharge from hospital'}, {'cui': 'C0042934', 'cui_str': 'Vocational counseling'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0204977', 'cui_str': 'Home care of patient'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}]","[{'cui': 'C0086279', 'cui_str': 'Family Caregivers'}]",,0.0611968,There was an interaction effect between the CG and the IG in the isolation domain (p = 0.037) and in the emotional involvement domain (p = 0.003) over time.,"[{'ForeName': 'Carolina B', 'Initials': 'CB', 'LastName': 'Day', 'Affiliation': 'School of health and life sciences, Pontifical Catholic University of Rio Grande do Sul (PUCRS), Porto Alegre, Brazil.'}, {'ForeName': 'Carla C B K', 'Initials': 'CCBK', 'LastName': 'Bierhals', 'Affiliation': 'Nursing Graduate Program, Nursing School, Federal University of Rio Grande do Sul (UFRGS), Porto Alegre, Brazil.'}, {'ForeName': 'Duane', 'Initials': 'D', 'LastName': 'Mocellin', 'Affiliation': 'Conceição Hospital Group, Porto Alegre, Brazil.'}, {'ForeName': 'Mariane L', 'Initials': 'ML', 'LastName': 'Predebon', 'Affiliation': 'Nursing Graduate Program, Nursing School, Federal University of Rio Grande do Sul (UFRGS), Porto Alegre, Brazil.'}, {'ForeName': 'Naiana O', 'Initials': 'NO', 'LastName': 'Santos', 'Affiliation': 'Nursing Department, Franciscan University Center (UNIFRA), Santa Maria, Brazil.'}, {'ForeName': 'Fernanda L F', 'Initials': 'FLF', 'LastName': 'Dal Pizzol', 'Affiliation': 'Nursing Graduate Program, Nursing School, Federal University of Rio Grande do Sul (UFRGS), Porto Alegre, Brazil.'}, {'ForeName': 'Ana Cláudia', 'Initials': 'AC', 'LastName': 'Furhmann', 'Affiliation': 'Nursing Graduate Program, Nursing School, Federal University of Rio Grande do Sul (UFRGS), Porto Alegre, Brazil.'}, {'ForeName': 'Marinês', 'Initials': 'M', 'LastName': 'Aires', 'Affiliation': 'Health of Science Department, Integrated Regional University of Alto Uruguai and Missões, Itapajé, Brazil.'}, {'ForeName': 'Lisiane M G', 'Initials': 'LMG', 'LastName': 'Paskulin', 'Affiliation': 'Nursing Graduate Program, Nursing School, Federal University of Rio Grande do Sul (UFRGS), Porto Alegre, Brazil.'}]",Health & social care in the community,['10.1111/hsc.13068'] 2271,32593779,ASPIRIN FOR THE PREVENTION OF PLACENTA-MEDIATED COMPLICATIONS IN PREGNANT WOMEN WITH CHRONIC HYPERTENSION.,"Chronic hypertension affects 1 to 5% of women of childbearing age. During pregnancy, chronic hypertension is associated with an increased risk of vascular disease such as superimposed preeclampsia (PE), intrauterine growth retardation (IUGR), placental abruption, and preterm delivery. These serious and frequent pathologies, specific to pregnancy, carry a particularly high risk of maternal complications (HELLP syndrome, eclampsia, maternal death) and perinatal complications (perinatal death, neurological disorders). To date, there is no curative treatment of vascular complications of chronic hypertension during pregnancy. The only effective treatment, once the complications are established, is usually stopping the pregnancy and delivering the placenta. Some recommendations suggest the use of low dose aspirin in the prevention of these complications. Although the efficacy of low-dose aspirin is assumed in patients with previous preeclampsia, few studies have evaluated its efficacy in patients with chronic hypertension. Controlled prospective studies using very low doses of aspirin (less than 100 mg) and started after 15 weeks of gestation do not seem conclusive. The objective of this work is first to detail the complications of chronic hypertension during pregnancy, then to analyze the studies which evaluated the interest of low dose aspirin in prevention of the placental vascular complications of the pregnancy in patients with chronic hypertension. We also propose an update on the European and North American national recommendations for the prevention of preeclampsia by low dose aspirin in the high-risk population of patients with chronic hypertension. Finally we present the CHASAP (Chronic Hypertension and Acetyl Salicylic Acid in Pregnancy) trial (NCT04356326), a multicentric prospective randomized double-blind superiority trial, which will compare, in pregnant women with chronic hypertension, the efficacy of low dose aspirin (150 mg/day) with a placebo, in the prevention of maternal-fetal morbidity and mortality (preeclampsia, placental abruption, IUGR, perinatal death, maternal death, and preterm delivery).",2020,"a multicentric prospective randomized double-blind superiority trial, which will compare, in pregnant women with chronic hypertension, the efficacy of low dose aspirin (150 mg/day) with a placebo, in the prevention of maternal-fetal morbidity and mortality (preeclampsia, placental abruption, IUGR, perinatal death, maternal death, and preterm delivery).","['pregnant women with chronic hypertension', 'patients with previous preeclampsia', '150\u2009mg/day) with a', 'patients with chronic hypertension']","['aspirin', 'placebo']","['Chronic hypertension', 'maternal-fetal morbidity and mortality (preeclampsia, placental abruption, IUGR, perinatal death, maternal death, and preterm delivery']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0032914', 'cui_str': 'Pre-eclampsia'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}]","[{'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0015965', 'cui_str': 'Fetuses'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0032914', 'cui_str': 'Pre-eclampsia'}, {'cui': 'C0000832', 'cui_str': 'Placental abruption'}, {'cui': 'C0015934', 'cui_str': 'Fetal growth restriction'}, {'cui': 'C0701826', 'cui_str': 'Perinatal death'}, {'cui': 'C0024923', 'cui_str': 'Maternal death'}, {'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}]",,0.0912185,"a multicentric prospective randomized double-blind superiority trial, which will compare, in pregnant women with chronic hypertension, the efficacy of low dose aspirin (150 mg/day) with a placebo, in the prevention of maternal-fetal morbidity and mortality (preeclampsia, placental abruption, IUGR, perinatal death, maternal death, and preterm delivery).","[{'ForeName': 'E', 'Initials': 'E', 'LastName': 'Lecarpentier', 'Affiliation': 'University Paris Est Créteil and CHI Créteil, Créteil, France; Department of Obstetrics Gynecology and Reproductive Medicine, University Paris Est Créteil, Centre Hospitalier Inter-Communal de Créteil, France.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Haddad', 'Affiliation': 'University Paris Est Créteil and CHI Créteil, Créteil, France; Department of Obstetrics Gynecology and Reproductive Medicine, University Paris Est Créteil, Centre Hospitalier Inter-Communal de Créteil, France. Electronic address: Bassam.Haddad@chicreteil.fr.'}]",Journal of gynecology obstetrics and human reproduction,['10.1016/j.jogoh.2020.101845'] 2272,32593791,Differential effects of modafinil on performance of low-performing and high-performing individuals during total sleep deprivation.,"BACKGROUND Individual responses to the effects of inadequate sleep have been well documented; some people are more vulnerable to the effects of sleep loss than others. Fatigue-vulnerable individuals generally require access to effective fatigue countermeasures; however, the question arises as to whether these fatigue-vulnerable individuals receive the same benefits shown in group efficacy data. The present study administered modafinil to individuals to determine its differential effects on performance of best and worst performers during sleep deprivation. METHODS A sample of 22 men, age 21-40 yrs., was tested on 2 separate occasions during which they were kept awake for 36 h. During one period they received 200 mg modafinil; during the other they received placebo. Participants were tested on a variety of tasks while rested and at 5-hr intervals across the continuous wakefulness period. Performance for each cognitive task and subjective measure of fatigue from the placebo period was used to group individuals into high (HP) or low performance (LP) groups to indicate fatigue vulnerability for each task. RESULTS Results indicated that on the MTS task, the HP group performed the same throughout the testing period, regardless of whether they received modafinil or not. However, the LP group significantly improved after receiving modafinil compared to placebo. Performance on the PVT showed the HP group had a small decrease in the number of lapses after receiving modafinil compared to placebo, whereas the LP group had a large decrease in lapses after receiving modafinil compared to placebo. Performance on the RDM showed no difference between groups, regardless of drug condition. Groups did not differ after receiving modafinil on subjective fatigue measured by the POMS. CONCLUSIONS Depending on the task, HP individuals did not benefit substantially when administered modafinil compared to placebo. However, the LP individuals improved after receiving modafinil compared to placebo.",2020,"Performance on the PVT showed the HP group had a small decrease in the number of lapses after receiving modafinil compared to placebo, whereas the LP group had a large decrease in lapses after receiving modafinil compared to placebo.","['low-performing and high-performing individuals during total sleep deprivation', 'group individuals into high (HP) or low performance (LP) groups to indicate fatigue vulnerability for each task', 'A sample of 22 men, age 21-40\u202fyrs., was tested on 2 separate occasions during which they were kept awake for 36\u202fh']","['modafinil', '200\u202fmg modafinil', 'placebo']","['subjective fatigue', 'lapses', 'number of lapses']","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0037316', 'cui_str': 'Sleep deprivation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0012655', 'cui_str': 'Diathesis'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0443299', 'cui_str': 'Separate'}, {'cui': 'C0234422', 'cui_str': 'Awake'}, {'cui': 'C0521125', 'cui_str': 'For'}]","[{'cui': 'C0066677', 'cui_str': 'modafinil'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0237753', 'cui_str': 'Number'}]",,0.090569,"Performance on the PVT showed the HP group had a small decrease in the number of lapses after receiving modafinil compared to placebo, whereas the LP group had a large decrease in lapses after receiving modafinil compared to placebo.","[{'ForeName': 'J Lynn', 'Initials': 'JL', 'LastName': 'Caldwell', 'Affiliation': 'Naval Medical Research Unit Dayton, United States of America. Electronic address: jo.caldwell@us.af.mil.'}, {'ForeName': 'Valarie M', 'Initials': 'VM', 'LastName': 'Schroeder', 'Affiliation': 'The Henry M. Jackson Foundation for the Advancement of Military Medicine, United States of America.'}, {'ForeName': 'Christina L', 'Initials': 'CL', 'LastName': 'Kunkle', 'Affiliation': 'The Henry M. Jackson Foundation for the Advancement of Military Medicine, United States of America.'}, {'ForeName': 'Henry G', 'Initials': 'HG', 'LastName': 'Stephenson', 'Affiliation': 'The Henry M. Jackson Foundation for the Advancement of Military Medicine, United States of America.'}]","Pharmacology, biochemistry, and behavior",['10.1016/j.pbb.2020.172968'] 2273,32593895,Effect of administration of β-hydroxy-β-methyl butyrate-enriched formula after liver transplantation: A pilot randomized controlled trial.,"OBJECTIVE Most patients undergoing liver transplantation (LT) have decreased skeletal muscle mass, malnutrition, and decreased physical activity levels. These comorbidities may prevent early recovery after surgery. The aim of this study was to examine the effects of oral nutritional formula-enriched β-hydroxy-β-methyl-butyrate (HMB), a leucine metabolite that promotes muscle synthesis and suppresses proteolysis, on postoperative sarcopenia and other outcomes after adult-to-adult living donor LT (LDLT). METHODS Thirty-three consecutive patients who underwent adult LDLT between March 2017 and October 2018 and who met inclusion criteria were randomly assigned in a 1:1 ratio to the HMB or control group. Patients in the HMB group received two packs of HMB-rich nutrients per day, which contained calcium-HMB (1500 mg), l-arginine (7000 mg), and l -glutamine (7000 mg) per pack orally or enterally from postoperative day 1 to 30 with postoperative rehabilitation. The primary endpoint was grip strength (GS) at 2 mo after LDLT. Secondary endpoints included GS at 1 mo after LDLT, skeletal muscle mass index (SMI) at 1 and 2 mo after LDLT, laboratory findings, incidence of postoperative bacteremia, and postoperative hospital length of stay (LOS). RESULTS Twelve patients in the HMB group and 11 in the control group were included in the final analysis. GS at 1 and 2 mo and SMI values at 2 mo were significantly higher in the HMB group than in the control group (GS: both P < 0.001, SMI: P = 0.04). In the HMB group, white blood cell count 3 wk after LDLT was significantly lower (P = 0.005), and postoperative hospital LOS was significantly shorter (P = 0.028) compared with the control group. The incidence of postoperative bacteremia was lower in the HMB group. CONCLUSIONS Postoperative administration of HMB-enriched formula with rehabilitation significantly increased GS at 1 and 2 mo and SMI at 2 mo and shortened postoperative hospital LOS after LDLT.",2020,"GS at 1 and 2 mo and SMI values at 2 mo were significantly higher in the HMB group than in the control group (GS: both P < 0.001, SMI: P = 0.04).","['patients undergoing liver transplantation (LT', 'after liver transplantation', 'adult-to-adult living donor LT (LDLT', 'Thirty-three consecutive patients who underwent adult LDLT between March 2017 and October 2018 and who met inclusion criteria', 'Twelve patients in the HMB group and 11 in the control group were included in the final analysis']","['HMB', 'oral nutritional formula-enriched β-hydroxy-β-methyl-butyrate (HMB), a leucine metabolite', 'HMB or control group', 'HMB-rich nutrients per day, which contained calcium-HMB (1500 mg), l-arginine (7000 mg), and l -glutamine', 'β-hydroxy-β-methyl butyrate-enriched formula']","['SMI values', 'grip strength (GS', 'white blood cell count', 'incidence of postoperative bacteremia', 'postoperative hospital LOS', 'GS at 1 mo after LDLT, skeletal muscle mass index (SMI) at 1 and 2 mo after LDLT, laboratory findings, incidence of postoperative bacteremia, and postoperative hospital length of stay (LOS', 'GS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023911', 'cui_str': 'Transplantation of liver'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0348050', 'cui_str': 'Live donor'}, {'cui': 'C0013018', 'cui_str': 'Donors'}, {'cui': 'C0450358', 'cui_str': '33'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0066231', 'cui_str': 'Methyl butyrate'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0066231', 'cui_str': 'Methyl butyrate'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0023401', 'cui_str': 'Leucine'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0678695', 'cui_str': 'Nutrients'}, {'cui': 'C0439505', 'cui_str': '/day'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C4517582', 'cui_str': '1500'}, {'cui': 'C0003765', 'cui_str': 'Arginine'}, {'cui': 'C4708914', 'cui_str': '7000'}, {'cui': 'C0017797', 'cui_str': 'Glutamine'}]","[{'cui': 'C0915075', 'cui_str': 'samarium diiodide'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0429271', 'cui_str': 'Grip strength'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0004610', 'cui_str': 'Bacteremia'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0348050', 'cui_str': 'Live donor'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0587081', 'cui_str': 'Laboratory test finding'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}]",33.0,0.0731392,"GS at 1 and 2 mo and SMI values at 2 mo were significantly higher in the HMB group than in the control group (GS: both P < 0.001, SMI: P = 0.04).","[{'ForeName': 'Naoko', 'Initials': 'N', 'LastName': 'Kamo', 'Affiliation': 'Division of Hepato-Biliary-Pancreatic and Transplant Surgery, Department of Surgery, Graduate School of Medicine, Kyoto University, Kyoto, Japan.'}, {'ForeName': 'Toshimi', 'Initials': 'T', 'LastName': 'Kaido', 'Affiliation': ""Division of Hepato-Biliary-Pancreatic and Transplant Surgery, Department of Surgery, Graduate School of Medicine, Kyoto University, Kyoto, Japan; Department of Gastroenterological and General Surgery, St Luke's International University and Hospital, Tokyo, Japan. Electronic address: kaido@kuhp.kyoto-u.ac.jp.""}, {'ForeName': 'Ryuji', 'Initials': 'R', 'LastName': 'Uozumi', 'Affiliation': 'Department of Biomedical Statistics and Bioinformatics, Kyoto University Graduate School of Medicine, Kyoto, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Ito', 'Affiliation': 'Division of Hepato-Biliary-Pancreatic and Transplant Surgery, Department of Surgery, Graduate School of Medicine, Kyoto University, Kyoto, Japan.'}, {'ForeName': 'Shintaro', 'Initials': 'S', 'LastName': 'Yagi', 'Affiliation': 'Division of Hepato-Biliary-Pancreatic and Transplant Surgery, Department of Surgery, Graduate School of Medicine, Kyoto University, Kyoto, Japan.'}, {'ForeName': 'Koichiro', 'Initials': 'K', 'LastName': 'Hata', 'Affiliation': 'Division of Hepato-Biliary-Pancreatic and Transplant Surgery, Department of Surgery, Graduate School of Medicine, Kyoto University, Kyoto, Japan.'}, {'ForeName': 'Kojiro', 'Initials': 'K', 'LastName': 'Taura', 'Affiliation': 'Division of Hepato-Biliary-Pancreatic and Transplant Surgery, Department of Surgery, Graduate School of Medicine, Kyoto University, Kyoto, Japan.'}, {'ForeName': 'Shinji', 'Initials': 'S', 'LastName': 'Uemoto', 'Affiliation': 'Division of Hepato-Biliary-Pancreatic and Transplant Surgery, Department of Surgery, Graduate School of Medicine, Kyoto University, Kyoto, Japan.'}]","Nutrition (Burbank, Los Angeles County, Calif.)",['10.1016/j.nut.2020.110871'] 2274,32593918,Early initiated postoperative rehabilitation enhances quality of life in patients with operable lung cancer: Secondary outcomes from a randomized trial.,"INTRODUCTION Patients with lung cancer report a lower degree of Health Related Quality of Life (HRQoL) compared with other cancer patients. HRQoL reflects how patients experience the impact of their disease and its treatment on their quality of daily living. A widely used questionnaire in lung cancer patients is the Functional Assessment of Cancer Therapy - Lung (FACT-L) questionnaire. Here we report the secondary outcomes on FACT-L data from the Postoperative Rehabilitation in Operation for Lung CAncer (PROLUCA) study, which describes the effect of early (14 days) versus late initiated (14 weeks) postoperative rehabilitation. MATERIALS AND METHODS The PROLUCA study was designed as a two-armed randomized controlled trial with an early rehabilitation group (14 days after surgery (ERG)) or a control arm with a late rehabilitation group (14 weeks after surgery (LRG)). The results for seven domain scores obtained using the FACT-L at the following time-points: baseline, 14 weeks, 26 weeks and 52 weeks after surgery are presented here. RESULTS 119 patients were randomized to the ERG and 116 to the LRG. In the ERG, HRQoL measured by both FACT-L and FACT-G (general core instrument) showed a continuous improvement up to 26 weeks after which HRQoL decreased after further 26 weeks without structured intervention. In the LRG a non-significant deterioration was detected over the first 14 weeks after surgery. After participation in the 12 weeks rehabilitation program, an increase in HRQoL was seen, without reaching the same level as the early group. CONCLUSION Analyses of the seven domain scores obtained using FACT-L and FACT-G reflect the importance of starting exercise early after surgery since the ERG avoid a temporary decrease in HRQoL. It is therefore recommended to start up a structured rehabilitation program 14 days after surgery, containing high intensity interval training and strength exercise twice a week for 12 weeks.",2020,"After participation in the 12 weeks rehabilitation program, an increase in HRQoL was seen, without reaching the same level as the early group. ","['lung cancer patients', 'patients with operable lung cancer', '119 patients']","['postoperative rehabilitation', 'early rehabilitation group (14 days after surgery (ERG)) or a control arm with a late rehabilitation group']","['quality of life', 'Health Related Quality of Life (HRQoL', 'HRQoL']","[{'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205188', 'cui_str': 'Operable'}]","[{'cui': 'C0877071', 'cui_str': 'Postoperative rehabilitation'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0205087', 'cui_str': 'Late'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}]",119.0,0.0636671,"After participation in the 12 weeks rehabilitation program, an increase in HRQoL was seen, without reaching the same level as the early group. ","[{'ForeName': 'Maja Schick', 'Initials': 'MS', 'LastName': 'Sommer', 'Affiliation': 'Copenhagen Centre for Cancer and Health, Denmark. Electronic address: mss@kraeftcenter-kbh.dk.'}, {'ForeName': 'Jette', 'Initials': 'J', 'LastName': 'Vibe-Petersen', 'Affiliation': 'Copenhagen Centre for Cancer and Health, Denmark.'}, {'ForeName': 'Maja Bohlbro', 'Initials': 'MB', 'LastName': 'Stærkind', 'Affiliation': 'The University Hospitals for Health Sciences, University Hospital of Copenhagen, Denmark.'}, {'ForeName': 'Seppo W', 'Initials': 'SW', 'LastName': 'Langer', 'Affiliation': 'Department of Oncology, Copenhagen University Hospital, Rigshospitalet, Denmark.'}, {'ForeName': 'Klaus Richter', 'Initials': 'KR', 'LastName': 'Larsen', 'Affiliation': 'Bispebjerg-Frederiksberg Hospital, University of Copenhagen, Denmark.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Trier', 'Affiliation': 'Copenhagen Centre for Cancer and Health, Denmark.'}, {'ForeName': 'Merete', 'Initials': 'M', 'LastName': 'Christensen', 'Affiliation': 'Department of Cardiothoracic Surgery, Copenhagen University Hospital, Rigshospitalet, Denmark.'}, {'ForeName': 'Paul F', 'Initials': 'PF', 'LastName': 'Clementsen', 'Affiliation': 'Department of Internal Medicine, Zealand University Hospital, Roskilde, Denmark; Copenhagen Academy for Medical Education and Simulation, University of Copenhagen and the Capital Region of Copenhagen, Denmark; Department of Clinical Medicine, University of Copenhagen, Denmark.'}, {'ForeName': 'Malene', 'Initials': 'M', 'LastName': 'Missel', 'Affiliation': 'Department of Cardiothoracic Surgery, Copenhagen University Hospital, Rigshospitalet, Denmark.'}, {'ForeName': 'Karl Bang', 'Initials': 'KB', 'LastName': 'Christensen', 'Affiliation': 'Section of Biostatistics, Department of Public Health, University of Copenhagen, Denmark.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Lillelund', 'Affiliation': 'The University Hospitals for Health Sciences, University Hospital of Copenhagen, Denmark.'}, {'ForeName': 'Henning', 'Initials': 'H', 'LastName': 'Langberg', 'Affiliation': 'Department of Public Health, Faculty of Health, University of Copenhagen, Denmark.'}, {'ForeName': 'Jesper H', 'Initials': 'JH', 'LastName': 'Pedersen', 'Affiliation': 'Department of Cardiothoracic Surgery, Copenhagen University Hospital, Rigshospitalet, Denmark.'}, {'ForeName': 'Morten', 'Initials': 'M', 'LastName': 'Quist', 'Affiliation': 'The University Hospitals for Health Sciences, University Hospital of Copenhagen, Denmark.'}]","Lung cancer (Amsterdam, Netherlands)",['10.1016/j.lungcan.2020.06.023'] 2275,32593936,Endometrial scratch injury with office hysteroscopy before IVF/ICSI: A randomised controlled trial.,"OBJECTIVE Endometrial scratch injury (ESI) has been proposed to improve endometrial receptivity and thereby increase implantation rates in assisted reproductive technology (ART) treatment. ESI has been widely incorporated into clinical practice despite inconclusive evidence of its effect on reproductive outcomes. We aimed to assess pregnancy and live birth rates in subfertile women receiving ESI before IVF treatment in comparison to controls. STUDY DESIGN This was a randomised controlled trial (RCT) with no blinding of participants, investigators or health care personnel. Women in ART treatment were allocated to either office hysteroscopy with ESI (ESI group) or no intervention (control group). In total 184 women in IVF/ICSI treatment with minimum one previous failed IVF/ICSI cycle, were included in the final analysis. The primary outcome was positive serum hCG (s-hCG). Secondary outcomes were ongoing pregnancy and live birth rate. Only per-protocol analyses were performed as all patients included at one centre had to be excluded. The trial is registered at ClinicalTrials.gov, NCT01743391. RESULTS Our results showed a non-significant increase in positive s-hCG (OR 1.23, 95 % CI (0.65-2.33)), ongoing pregnancy (OR 1.52, 95 % CI (0.73-3.17)), and live birth rates (OR 1.69, 95 % CI (0.78-3.64)) per randomised woman between the ESI and the control group. CONCLUSION We observed no significant differences in positive s-hCG or other reproductive outcomes in the ESI vs. the control group. While the crude estimates of positive reproductive outcomes were higher in the ESI group, statistical significance was not reached, and the study was not powered to show smaller differences. However, data from this study will be re-evaluated in the context of an individual participant data meta-analysis (IPD-MA) of RCTs on ESI.",2020,Women in ART treatment were allocated to either office hysteroscopy with ESI (ESI group) or no intervention (control group).,"['In total 184 women in IVF/ICSI treatment with minimum one previous failed IVF/ICSI cycle, were included in the final analysis', 'Endometrial scratch injury with office hysteroscopy before IVF/ICSI', 'subfertile women receiving ESI before IVF treatment in comparison to controls', 'Women in ART treatment', 'participants, investigators or health care personnel']","['office hysteroscopy with ESI (ESI group) or no intervention (control group', 'ESI']","['positive reproductive outcomes', 'live birth rates', 'ongoing pregnancy and live birth rate', 'ongoing pregnancy', 'positive s-hCG', 'pregnancy and live birth rates', 'positive serum hCG (s-hCG']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517616', 'cui_str': '184'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0015915', 'cui_str': 'In vitro fertilization'}, {'cui': 'C0455164', 'cui_str': 'IVF - In vitro fertilization with intracytoplasmic sperm injection (ICSI)'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0311213', 'cui_str': 'Dermatitis verrucosa'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C0020710', 'cui_str': 'Hysteroscopy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0035157', 'cui_str': 'Reproductive Technologies'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}]","[{'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C0020710', 'cui_str': 'Hysteroscopy'}, {'cui': 'C0311213', 'cui_str': 'Dermatitis verrucosa'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0035150', 'cui_str': 'Reproduction'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0481667', 'cui_str': 'Live birth'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C1141639', 'cui_str': 'Human chorionic gonadotropin'}]",184.0,0.498981,Women in ART treatment were allocated to either office hysteroscopy with ESI (ESI group) or no intervention (control group).,"[{'ForeName': 'Sine', 'Initials': 'S', 'LastName': 'Berntsen', 'Affiliation': 'Department of Obstetrics and Gynaecology, Hvidovre Hospital, Copenhagen University Hospital, Kettegaard Allé 30, 2650, Hvidovre, Denmark; The Fertility Clinic, Hvidovre Hospital, Copenhagen University Hospital, Kettegaard Allé 30, 2650, Hvidovre, Denmark. Electronic address: sine.berntsen.01@regionh.dk.'}, {'ForeName': 'Kristine Juul', 'Initials': 'KJ', 'LastName': 'Hare', 'Affiliation': 'Department of Obstetrics and Gynaecology, Hvidovre Hospital, Copenhagen University Hospital, Kettegaard Allé 30, 2650, Hvidovre, Denmark.'}, {'ForeName': 'Kristine', 'Initials': 'K', 'LastName': 'Løssl', 'Affiliation': 'The Fertility Clinic, Hvidovre Hospital, Copenhagen University Hospital, Kettegaard Allé 30, 2650, Hvidovre, Denmark; The Fertility Clinic, Rigshospitalet, Copenhagen University Hospital, Blegdamsvej 9, 2100 Copenhagen, Denmark.'}, {'ForeName': 'Jeanette', 'Initials': 'J', 'LastName': 'Bogstad', 'Affiliation': 'The Fertility Clinic, Hvidovre Hospital, Copenhagen University Hospital, Kettegaard Allé 30, 2650, Hvidovre, Denmark; The Fertility Clinic, Rigshospitalet, Copenhagen University Hospital, Blegdamsvej 9, 2100 Copenhagen, Denmark.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Palmø', 'Affiliation': 'Department of Obstetrics and Gynaecology, Holbaek Hospital, Smedelundsgade 60, 4300 Holbaek, Denmark.'}, {'ForeName': 'Lisbeth', 'Initials': 'L', 'LastName': 'Prætorius', 'Affiliation': 'The Fertility Clinic, Hvidovre Hospital, Copenhagen University Hospital, Kettegaard Allé 30, 2650, Hvidovre, Denmark.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Zedeler', 'Affiliation': 'The Fertility Clinic, Hvidovre Hospital, Copenhagen University Hospital, Kettegaard Allé 30, 2650, Hvidovre, Denmark.'}, {'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'Pinborg', 'Affiliation': 'The Fertility Clinic, Hvidovre Hospital, Copenhagen University Hospital, Kettegaard Allé 30, 2650, Hvidovre, Denmark; The Fertility Clinic, Rigshospitalet, Copenhagen University Hospital, Blegdamsvej 9, 2100 Copenhagen, Denmark.'}]","European journal of obstetrics, gynecology, and reproductive biology",['10.1016/j.ejogrb.2020.06.034'] 2276,32593960,Functional recovery in multiple sclerosis patients undergoing rehabilitation programs is associated with plasma levels of hemostasis inhibitors.,"BACKGROUND Increasing evidence for contribution of hemostasis components in multiple sclerosis (MS) has been reported. Hemostasis protein inhibitors display key regulatory roles, extending to regulation of innate immune response and inflammation, and promotion of blood-brain barrier integrity. Whereas the effects on hemostasis of exercise and rehabilitation strategies have been extensively investigated, relationships between MS rehabilitation strategies and hemostasis have not been previously reported. OBJECTIVES To investigate in MS patients the association between outcomes of rehabilitative exercise and plasma levels of selected hemostasis inhibitors. METHODS Sixty-one severely disabled progressive-MS (P-MS) patients were randomized in the RAGTIME trial to receive 12 walking session of robot-assisted gait training (RAGT) or conventional overground therapy (CT). Outcome parameters were: timed 25-foot walk test (T25FWT) speed, 6-minute walking test (6MWT), Berg Balance Scale (BBS), and MS impact scale-29 (MSIS-29). Plasma levels of coagulation inhibitors protein S (PS), soluble thrombomodulin (sTM), and tissue factor pathway inhibitor (TFPI) were assayed by multiplex assay and ELISA at 4-time points: baseline (T0), intermediate (T1), end of rehabilitation (T2), 3-month follow-up (T3). Descriptive analysis, trend analysis, Spearman's rank and Pearson's correlations, and multiple regression models were used. RESULTS Rehabilitative exercises moderately modified plasma protein concentrations. A significant trend to increase was observed for PS (p=0.015) and TFPI (p=0.047) in the whole population, and for PS (p=0.011) in the CT group. Correlation between TFPI and sTM levels was detectable at all time points in the whole P-MS patients and in RAGT group. The correlation between TFPI and PS, present at T0, was lost during the rehabilitation, and recovered at T3 in the whole population and CT group. During rehabilitation, positive variations of TFPI were inversely related with changes in 6MWT in the whole population (r=-0.309, p=0.021), and in the RAGT group (r=-0.51, p=0.004). In all P-MS, PS T0 levels were associated (r=0.379, p=0.004) with increased gait speed, which in the RAGT group was associated both with PS T0 (r=0.378, p=0.040), and sTM T0 (r=0.453, p=0.012). Accordingly, in the regression model including age, sex and EDSS and the stepwise enter of PS T0, higher PS T0 levels predicted increased gait speed in all P-MS (F=3.4, p=0.016) The regression model in the RAGT group indicated that higher PS and sTM T0 levels were both predictors of increased gait speed (F=5.7, p=0.001). CONCLUSIONS Plasma levels of coagulation inhibitors were related to variations of outcome measurements after high-intensity walking rehabilitation programs. Patients with decreased TFPI levels from T0 to T2 displayed the most significant functional recovery following rehabilitation, and particularly after RAGT. Higher baseline total PS levels were associated with favorable outcomes of rehabilitation therapies in MS. These novel findings, which suggest that plasma levels of hemostasis inhibitors might have implication for rehabilitative therapy options in MS, warrant further investigation.",2020,"Plasma levels of coagulation inhibitors protein S (PS), soluble thrombomodulin (sTM), and tissue factor pathway inhibitor (TFPI) were assayed by multiplex assay and ELISA at 4-time points: baseline (T0), intermediate (T1), end of rehabilitation (T2), 3-month follow-up (T3).","['Sixty-one severely disabled progressive-MS (P-MS) patients', 'multiple sclerosis patients undergoing rehabilitation programs', 'multiple sclerosis (MS']",['12 walking session of robot-assisted gait training (RAGT) or conventional overground therapy (CT'],"['PS T0 levels', 'TFPI levels', 'Higher baseline total PS levels', 'gait speed', 'Plasma levels of coagulation inhibitors protein S (PS), soluble thrombomodulin (sTM), and tissue factor pathway inhibitor (TFPI', 'timed 25-foot walk test (T25FWT) speed, 6-minute walking test (6MWT), Berg Balance Scale (BBS), and MS impact scale-29 (MSIS-29', 'plasma protein concentrations', 'PS', 'TFPI', 'PS and sTM T0 levels', 'TFPI and sTM levels', 'multiplex assay and ELISA at 4-time points: baseline (T0), intermediate (T1), end of rehabilitation (T2), 3-month follow-up (T3']","[{'cui': 'C4517832', 'cui_str': '61'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1095979', 'cui_str': 'Progressive multiple sclerosis'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}]","[{'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0085673', 'cui_str': 'Gait training procedure'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0072393', 'cui_str': 'Protein S'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0164707', 'cui_str': 'Tissue factor pathway inhibitor'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C1168441', 'cui_str': 'Protein S total'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0005778', 'cui_str': 'Coagulation, Blood'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0145779', 'cui_str': 'Thrombomodulin'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1998325', 'cui_str': 'Berg balance scale'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0032120', 'cui_str': 'Plasma protein'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0005507', 'cui_str': 'Bioassay'}, {'cui': 'C0014441', 'cui_str': 'Enzyme-linked immunosorbent assay'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]",61.0,0.0295241,"Plasma levels of coagulation inhibitors protein S (PS), soluble thrombomodulin (sTM), and tissue factor pathway inhibitor (TFPI) were assayed by multiplex assay and ELISA at 4-time points: baseline (T0), intermediate (T1), end of rehabilitation (T2), 3-month follow-up (T3).","[{'ForeName': 'Ziliotto', 'Initials': 'Z', 'LastName': 'Nicole', 'Affiliation': 'Department of Life Sciences and Biotechnology, University of Ferrara; Current affiliation: School of Medicine and Surgery, University of Milano - Bicocca, Monza, Ferrara, Italy.'}, {'ForeName': 'Lamberti', 'Initials': 'L', 'LastName': 'Nicola', 'Affiliation': 'Department of Biomedical and Surgical Specialties Sciences, University of Ferrara, Ferrara, Italy.'}, {'ForeName': 'Manfredini', 'Initials': 'M', 'LastName': 'Fabio', 'Affiliation': 'Department of Biomedical and Surgical Specialties Sciences, University of Ferrara, Ferrara, Italy; Department of Neurosciences/Rehabilitation, Unit of Physical and Rehabilitation Medicine, University Hospital of Ferrara, Ferrara, Italy.'}, {'ForeName': 'Straudi', 'Initials': 'S', 'LastName': 'Sofia', 'Affiliation': 'Department of Neurosciences/Rehabilitation, Unit of Physical and Rehabilitation Medicine, University Hospital of Ferrara, Ferrara, Italy.'}, {'ForeName': 'Baroni', 'Initials': 'B', 'LastName': 'Marcello', 'Affiliation': 'Department of Life Sciences and Biotechnology, University of Ferrara.'}, {'ForeName': 'Tisato', 'Initials': 'T', 'LastName': 'Veronica', 'Affiliation': 'Department of Morphology, Surgery and Experimental Medicine and LTTA Centre, University of Ferrara, Ferrara, Italy.'}, {'ForeName': 'Carantoni', 'Initials': 'C', 'LastName': 'Matteo', 'Affiliation': 'Department of Morphology, Surgery and Experimental Medicine and LTTA Centre, University of Ferrara, Ferrara, Italy.'}, {'ForeName': 'Secchiero', 'Initials': 'S', 'LastName': 'Paola', 'Affiliation': 'Department of Morphology, Surgery and Experimental Medicine and LTTA Centre, University of Ferrara, Ferrara, Italy.'}, {'ForeName': 'Basaglia', 'Initials': 'B', 'LastName': 'Nino', 'Affiliation': 'Department of Neurosciences/Rehabilitation, Unit of Physical and Rehabilitation Medicine, University Hospital of Ferrara, Ferrara, Italy.'}, {'ForeName': 'Marchetti', 'Initials': 'M', 'LastName': 'Giovanna', 'Affiliation': 'Department of Biomedical and Surgical Specialties Sciences, University of Ferrara, Ferrara, Italy.'}, {'ForeName': 'Bernardi', 'Initials': 'B', 'LastName': 'Francesco', 'Affiliation': 'Department of Life Sciences and Biotechnology, University of Ferrara. Electronic address: ber@unife.it.'}]",Multiple sclerosis and related disorders,['10.1016/j.msard.2020.102319'] 2277,32594123,Comment on: Long-term efficacy and safety of tocilizumab in refractory Takayasu arteritis: final results of the randomized controlled phase 3 TAKT study.,,2020,,['refractory Takayasu arteritis'],['tocilizumab'],[],"[{'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0039263', 'cui_str': ""Takayasu's disease""}]","[{'cui': 'C1609165', 'cui_str': 'tocilizumab'}]",[],,0.0466438,,"[{'ForeName': 'Ryu', 'Initials': 'R', 'LastName': 'Watanabe', 'Affiliation': 'Department of Rheumatology, Osaki Citizen Hospital, Osaki, Japan.'}]","Rheumatology (Oxford, England)",['10.1093/rheumatology/keaa253'] 2278,32594135,Co-administration of 5α-reductase inhibitors worsens the adverse metabolic effects of prescribed glucocorticoids.,"CONTEXT Glucocorticoids (GC) are commonly prescribed, but their use is associated with adverse metabolic effects. 5a-reductase inhibitors (5aRI) are also frequently prescribed, mainly to inhibit testosterone conversion to dihydrotestosterone. However, they also prevent the inactivation of GCs. OBJECTIVE We hypothesised that 5aRIs may worsen the adverse effects of GCs. DESIGN Prospective, randomised study. PATIENTS 19 healthy male volunteers (age; 45±2 years, BMI; 27.1±0.7kg/m2). INTERVENTIONS Participants underwent metabolic assessments; 2-step hyperinsulinemic, euglycemic clamp incorporating stable-isotopes, adipose tissue microdialysis and biopsy. Participants were then randomised to either prednisolone (10mg daily) or prednisolone (10mg daily) plus a 5aRI (finasteride 5mg daily or dutasteride 0.5mg daily) for 7 days; metabolic assessments were then repeated. MAIN OUTCOME MEASURES Ra glucose, glucose utilization (M-value), glucose oxidation, non-esterified fatty acids (NEFA) levels. RESULTS Co-administration of prednisolone with a 5aRI increased circulating prednisolone levels (482±96 vs. 761±57nmol/L, p=0.029). Prednisolone alone did not alter Ra glucose (2.55±0.34 vs 2.62±0.19mg/kg/min, p=0.86), M-value (3.2±0.5 vs 2.7±0.7mg/kg/min, p=0.37), or glucose oxidation (0.042±0.007 vs 0.040±0.004mmol/hr/kg/min, p=0.79). However, co-administration with a 5aRI increased Ra glucose (2.67±0.16 vs. 3.05±0.18mg/kg/min, p<0.05) and decreased M-value (4.0±0.5 vs. 2.6±0.4mg/kg/min, p<0.05), and oxidation (0.043±0.003 vs. 0.036±0.002mmol/hr/kg, p<0.01). Similarly, prednisolone did not impair insulin-mediated suppression of circulating NEFA (43.1±28.9 vs. 36.8±14.3μmol/L, p=0.81), unless co-administered with a 5aRI (49.8±8.6 vs. 88.5±13.5μmol/L, p<0.01). CONCLUSIONS We have demonstrated that 5aRIs exacerbate the adverse effects of prednisolone. This study has significant translational implications, including the need to consider GC dose adjustments, but also the necessity for increased vigilance for the development of adverse effects.",2020,"Similarly, prednisolone did not impair insulin-mediated suppression of circulating NEFA (43.1±28.9 vs. 36.8±14.3μmol/L, p=0.81), unless co-administered with a 5aRI (49.8±8.6 vs. 88.5±13.5μmol/L, p<0.01). ","['19 healthy male volunteers (age; 45±2 years, BMI; 27.1±0.7kg/m2']","['5α-reductase inhibitors', '5aRI (finasteride 5mg daily or dutasteride', 'hyperinsulinemic, euglycemic clamp incorporating stable-isotopes, adipose tissue microdialysis and biopsy', 'Prednisolone', 'prednisolone']","['adverse metabolic effects', 'M-value', 'Ra glucose', 'Ra glucose, glucose utilization (M-value), glucose oxidation, non-esterified fatty acids (NEFA) levels', 'circulating prednisolone levels', 'glucose oxidation', 'insulin-mediated suppression of circulating NEFA']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C0030016', 'cui_str': 'Oxidoreductase'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0986066', 'cui_str': 'Finasteride 5 MG'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0754659', 'cui_str': 'Dutasteride'}, {'cui': 'C0079318', 'cui_str': 'Euglycaemic Clamp'}, {'cui': 'C0302918', 'cui_str': 'Stable isotope'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0206056', 'cui_str': 'Microdialysis'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0032950', 'cui_str': 'prednisolone'}]","[{'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}, {'cui': 'C0369212', 'cui_str': 'Esterified fatty acid'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0032950', 'cui_str': 'prednisolone'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}]",19.0,0.0933746,"Similarly, prednisolone did not impair insulin-mediated suppression of circulating NEFA (43.1±28.9 vs. 36.8±14.3μmol/L, p=0.81), unless co-administered with a 5aRI (49.8±8.6 vs. 88.5±13.5μmol/L, p<0.01). ","[{'ForeName': 'Nantia', 'Initials': 'N', 'LastName': 'Othonos', 'Affiliation': 'Oxford Centre for Diabetes, Endocrinology and Metabolism, NIHR Oxford Biomedical Research Centre, University of Oxford, Churchill Hospital, Oxford, UK.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Marjot', 'Affiliation': 'Translational Gastroenterology Unit, NIHR Oxford Biomedical Research Centre, University of Oxford, John Radcliffe Hospital, Oxford, UK.'}, {'ForeName': 'Conor', 'Initials': 'C', 'LastName': 'Woods', 'Affiliation': 'Department of Endocrinology, Naas General Hospital, Kildare and Tallaght Hospital, Dublin, Ireland.'}, {'ForeName': 'Jonathan M', 'Initials': 'JM', 'LastName': 'Hazlehurst', 'Affiliation': 'Institute of Metabolism and Systems Research, University of Birmingham, Edgbaston, Birmingham, UK.'}, {'ForeName': 'Nikolaos', 'Initials': 'N', 'LastName': 'Nikolaou', 'Affiliation': 'Oxford Centre for Diabetes, Endocrinology and Metabolism, NIHR Oxford Biomedical Research Centre, University of Oxford, Churchill Hospital, Oxford, UK.'}, {'ForeName': 'Riccardo', 'Initials': 'R', 'LastName': 'Pofi', 'Affiliation': 'Department of Experimental Medicine, Sapienza University of Rome, Rome, Italy, Viale Regina Elena, Rome, Italy.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'White', 'Affiliation': 'Oxford Centre for Diabetes, Endocrinology and Metabolism, NIHR Oxford Biomedical Research Centre, University of Oxford, Churchill Hospital, Oxford, UK.'}, {'ForeName': 'Ilaria', 'Initials': 'I', 'LastName': 'Bonaventura', 'Affiliation': 'Department of Experimental Medicine, Sapienza University of Rome, Rome, Italy, Viale Regina Elena, Rome, Italy.'}, {'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Webster', 'Affiliation': 'Department of Pathology, University Hospitals Birmingham, NHS Foundation Trust, Birmingham, UK.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Duffy', 'Affiliation': 'Department of Pathology, University Hospitals Birmingham, NHS Foundation Trust, Birmingham, UK.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Cornfield', 'Affiliation': 'Oxford Centre for Diabetes, Endocrinology and Metabolism, NIHR Oxford Biomedical Research Centre, University of Oxford, Churchill Hospital, Oxford, UK.'}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Moolla', 'Affiliation': 'Oxford Centre for Diabetes, Endocrinology and Metabolism, NIHR Oxford Biomedical Research Centre, University of Oxford, Churchill Hospital, Oxford, UK.'}, {'ForeName': 'Andrea M', 'Initials': 'AM', 'LastName': 'Isidori', 'Affiliation': 'Department of Experimental Medicine, Sapienza University of Rome, Rome, Italy, Viale Regina Elena, Rome, Italy.'}, {'ForeName': 'Leanne', 'Initials': 'L', 'LastName': 'Hodson', 'Affiliation': 'Oxford Centre for Diabetes, Endocrinology and Metabolism, NIHR Oxford Biomedical Research Centre, University of Oxford, Churchill Hospital, Oxford, UK.'}, {'ForeName': 'Jeremy W', 'Initials': 'JW', 'LastName': 'Tomlinson', 'Affiliation': 'Oxford Centre for Diabetes, Endocrinology and Metabolism, NIHR Oxford Biomedical Research Centre, University of Oxford, Churchill Hospital, Oxford, UK.'}]",The Journal of clinical endocrinology and metabolism,['10.1210/clinem/dgaa408'] 2279,32594139,The Effect of Transcranial Direct Current Stimulation on Chronic Neuropathic Pain in Patients with Multiple Sclerosis: Randomized Controlled Trial.,"OBJECTIVE Chronic neuropathic pain is a common symptom in multiple sclerosis (MS). This randomized controlled single-blinded study investigated whether a new protocol involving five days of transcranial direct current stimulation (tDCS) with an interval period would be effective to reduce pain using the visual analog scale (VAS). Other secondary outcomes included the Neuropathic Pain Scale (NPS), Depression Anxiety Stress Score (DASS), Short Form McGill Pain Questionnaire (SFMPQ), and Multiple Sclerosis Quality of Life 54 (MSQOL54). DESIGN A total of 30 participants were recruited for the study, with 15 participants randomized to a sham group or and 15 randomized to an active group. After a five-day course of a-tDCS, VAS and NPS scores were measured daily and then weekly after treatment up to four weeks after treatment. Secondary outcomes were measured pretreatment and then weekly up to four weeks. RESULTS After a five-day course of a-tDCS, VAS scores were significantly reduced compared with sham tDCS and remained significantly low up to week 2 post-treatment. There were no statistically significant mean changes in MSQOL54, SFMPQ, NPS, or DASS for the sham or treatment group before treatment or at four-week follow-up. CONCLUSIONS This study shows that repeated stimulation with a-tDCS for five days can reduce pain intensity for a prolonged period in patients with MS who have chronic neuropathic pain.",2020,"There were no statistically significant mean changes in MSQOL54, SFMPQ, NPS, or DASS for the sham or treatment group before treatment or at four-week follow-up. ","['patients with MS who have chronic neuropathic pain', 'A total of 30 participants were recruited for the study, with 15 participants randomized to a sham group or and 15 randomized to an active group', 'Patients with Multiple Sclerosis']","['Transcranial Direct Current Stimulation', 'transcranial direct current stimulation (tDCS']","['MSQOL54, SFMPQ, NPS, or DASS', 'Chronic Neuropathic Pain', 'pain intensity', 'VAS and NPS scores', 'pain using the visual analog scale (VAS', 'Neuropathic Pain Scale (NPS), Depression Anxiety Stress Score (DASS), Short Form McGill Pain Questionnaire (SFMPQ), and Multiple Sclerosis Quality of Life 54 (MSQOL54', 'VAS scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C4544057', 'cui_str': 'Chronic neuropathic pain'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205177', 'cui_str': 'Active'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}]","[{'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0457972', 'cui_str': 'Short form McGill pain questionnaire'}, {'cui': 'C0027796', 'cui_str': 'Neuralgia'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0338908', 'cui_str': 'Mixed anxiety and depressive disorder'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C4544057', 'cui_str': 'Chronic neuropathic pain'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}]",30.0,0.163051,"There were no statistically significant mean changes in MSQOL54, SFMPQ, NPS, or DASS for the sham or treatment group before treatment or at four-week follow-up. ","[{'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Young', 'Affiliation': 'Rehabilitation\xa0Department, Royal Melbourne Hospital, Royal Park Campus, Melbourne, Australia.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Zoghi', 'Affiliation': 'Department of Rehabilitation, Nutrition and Sport, Discipline of Physiotherapy, School of Allied Health, La Trobe University, Melbourne, Australia.'}, {'ForeName': 'Fary', 'Initials': 'F', 'LastName': 'Khan', 'Affiliation': 'Rehabilitation\xa0Department, Royal Melbourne Hospital, Royal Park Campus, Melbourne, Australia.'}, {'ForeName': 'Mary P', 'Initials': 'MP', 'LastName': 'Galea', 'Affiliation': 'Rehabilitation\xa0Department, Royal Melbourne Hospital, Royal Park Campus, Melbourne, Australia.'}]","Pain medicine (Malden, Mass.)",['10.1093/pm/pnaa128'] 2280,32594147,Comment on: Long-term efficacy and safety of tocilizumab in refractory Takayasu arteritis: final results of the randomized controlled phase 3 TAKT study: reply.,,2020,,['refractory Takayasu arteritis'],['tocilizumab'],[],"[{'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0039263', 'cui_str': ""Takayasu's disease""}]","[{'cui': 'C1609165', 'cui_str': 'tocilizumab'}]",[],,0.0443197,,"[{'ForeName': 'Yoshikazu', 'Initials': 'Y', 'LastName': 'Nakaoka', 'Affiliation': 'Department of Vascular Physiology, National Cerebral and Cardiovascular Center Research Institute, Suita Japan.'}, {'ForeName': 'Katsuhisa', 'Initials': 'K', 'LastName': 'Yamashita', 'Affiliation': 'Department of Cardiovascular Medicine, Osaka University Graduate School of Medicine, Osaka Japan.'}, {'ForeName': 'Shinji', 'Initials': 'S', 'LastName': 'Yamakido', 'Affiliation': 'Chugai Pharmaceutical Co. Ltd, Tokyo, Japan.'}]","Rheumatology (Oxford, England)",['10.1093/rheumatology/keaa255'] 2281,32594478,Testing an Internet-Based Turkish Obesity Behavioral Therapy Program: A Randomized Study.,"OBJECTIVE Behavioral treatment is recommended as the first line intervention for the prevention of health problems pertaining to obesity. Internet-based programs are used to provide cognitive behavioral therapy for psychiatric disorders and systemic diseases to a large number of patients at low cost. The aim of this study is to develop the first internet based Turkish obesity behavioral therapy program and test its short-term effectiveness. METHOD A Turkish web-based behavioral therapy program based on the behavioral strategies employed in the Diabetes Prevention Program was generated. In order to test the effectiveness of this internet-based program an eight week randomized study was conducted. A total of 101 overweight participants with body mass index in the 25-40 range were randomly assigned to an eight-week weight loss program using either the Internet Behavior Therapy (IBT, n=51) or e-mail education (EE, n=50). The participants in the IBT group were provided access to an Internet program that provided videos teaching behavioral weight-loss skills as well as a self-monitoring platform to calculate the daily calorie balance. The participants in the EE group received weekly e-mails with information on healthy eating, physical exercises and weight loss for eight weeks. The primary outcome measure was the observed weight change at the end of the 8 weeks. RESULTS In the analyses wherein baseline weight was carried forward for missing data, the IBT produced significantly larger mean weight loss in comparison to the EE at the end of the 8 weeks [2.28 kg (2.11) vs. 0.74 kg (1.57), p=0.001]. The participants in the IBT group, when compared to the EE group, were also more likely to achieve a clinically significant weight loss of 5% of their initial body weight at the end of the 8-week study period (17.6% vs. 2%, p=0.016). CONCLUSION The participants who received a structured IBT intervention lost significantly more weight after two months, compared to those who received weekly informational emails regarding weight loss. Internet-based behavioral therapy programs may have the potential to serve as a low-cost alternative for obese patients.",2020,"The participants who received a structured IBT intervention lost significantly more weight after two months, compared to those who received weekly informational emails regarding weight loss.","['obese patients', '101 overweight participants with body mass index in the 25-40 range']","['Internet program that provided videos teaching behavioral weight-loss skills as well as a self-monitoring platform to calculate the daily calorie balance', 'eight-week weight loss program using either the Internet Behavior Therapy (IBT, n=51) or e-mail education', 'Internet-Based Turkish Obesity Behavioral Therapy Program', 'cognitive behavioral therapy', 'Internet-based behavioral therapy programs', 'structured IBT intervention', 'weekly e-mails with information on healthy eating, physical exercises']","['mean weight loss', 'weight', 'initial body weight', 'weight loss', 'observed weight change']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0039401', 'cui_str': 'Education'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0588436', 'cui_str': 'Self monitoring'}, {'cui': 'C0444686', 'cui_str': 'Calculated'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C3179079', 'cui_str': 'Weight Loss Programs'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C0013849', 'cui_str': 'Email'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0041402', 'cui_str': 'Turkish language'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0452415', 'cui_str': 'Healthy diet'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0005911', 'cui_str': 'Weight change'}]",101.0,0.0220988,"The participants who received a structured IBT intervention lost significantly more weight after two months, compared to those who received weekly informational emails regarding weight loss.","[{'ForeName': 'Cenan', 'Initials': 'C', 'LastName': 'Hepdurgun', 'Affiliation': ''}, {'ForeName': 'Özgün', 'Initials': 'Ö', 'LastName': 'Özalay', 'Affiliation': ''}, {'ForeName': 'Şebnem', 'Initials': 'Ş', 'LastName': 'Pırıldar', 'Affiliation': ''}, {'ForeName': 'Gülbin', 'Initials': 'G', 'LastName': 'Rudarlı Nalçakan', 'Affiliation': ''}, {'ForeName': 'Lütfiye Füsun', 'Initials': 'LF', 'LastName': 'Saygılı', 'Affiliation': ''}, {'ForeName': 'Selda', 'Initials': 'S', 'LastName': 'Seçkiner', 'Affiliation': ''}, {'ForeName': 'Murat Osman', 'Initials': 'MO', 'LastName': 'Ünalır', 'Affiliation': ''}, {'ForeName': 'Hayriye', 'Initials': 'H', 'LastName': 'Elbi', 'Affiliation': ''}]",Turk psikiyatri dergisi = Turkish journal of psychiatry,[] 2282,32594479,The Effect of Life Skills Training on Functioning in Schizophrenia: A Randomized Controlled Trial.,"OBJECTIVE Psychosocial approaches including occupational therapeutic interventions constitute an important part of mental health treatments. This research was planned to investigate the effects of individualized life skills training on the functionality of individuals diagnosed with schizophrenia. METHOD A total of 32 individuals diagnosed with schizophrenia were assigned randomly to the study (n=15) and the control groups (n=17). The participants were evaluated with the Positive and Negative Syndrome Scale for symptom severity, the Clinical Global Impression Scale for illness severity and improvement and response to treatment, the Katz Index of Independence in Activities of Daily Living and the Lawton - Brody Instrumental Activities of Daily Living Scale for adequacy of performance of basic activities and tasks of daily living, the Functioning Assessment Short Test and Social Functioning Scale for assessing the level of functionality before and after the scheduled interventions for both groups. The control group received a singlesession awareness training to increase independence in daily living activities and the study group received individualized life skills training in 2 sessions per week for 8 weeks (=16 sessions). RESULTS At the end of the research program, improvements were observed in the negative symptoms, general psychopathology, severity of illness and independence in basic and instrumental activities of daily living and functioning in the study group as compared to the control group. CONCLUSION On the basis of the obtained results, we believe that the individualized life skills training may be an effective therapeutic method for the rehabilitation of individuals diagnosed with schizophrenia. The results of our study should be supported by long-term follow-up studies.",2020,"At the end of the research program, improvements were observed in the negative symptoms, general psychopathology, severity of illness and independence in basic and instrumental activities of daily living and functioning in the study group as compared to the control group. ","['32 individuals diagnosed with schizophrenia', 'individuals diagnosed with schizophrenia', 'Schizophrenia']","['singlesession awareness training', 'Life Skills Training', 'individualized life skills training']","['Positive and Negative Syndrome Scale for symptom severity, the Clinical Global Impression Scale for illness severity and improvement and response to treatment, the Katz Index of Independence in Activities of Daily Living and the Lawton - Brody Instrumental Activities of Daily Living Scale for adequacy of performance of basic activities and tasks of daily living, the Functioning Assessment Short Test and Social Functioning Scale', 'negative symptoms, general psychopathology, severity of illness and independence in basic and instrumental activities of daily living and functioning']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}]","[{'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0556562', 'cui_str': 'Life skills training'}]","[{'cui': 'C0451383', 'cui_str': 'Positive and negative syndrome scale'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C3639708', 'cui_str': 'Clinical global impression scale'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0521982', 'cui_str': 'Response to treatment'}, {'cui': 'C0451239', 'cui_str': 'Katz activities of daily living'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0150641', 'cui_str': 'Instrumental activities of daily living'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C2585826', 'cui_str': 'Social functioning scale'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0033927', 'cui_str': 'Psychopathology'}]",32.0,0.0243496,"At the end of the research program, improvements were observed in the negative symptoms, general psychopathology, severity of illness and independence in basic and instrumental activities of daily living and functioning in the study group as compared to the control group. ","[{'ForeName': 'Hatice', 'Initials': 'H', 'LastName': 'Abaoğlu', 'Affiliation': ''}, {'ForeName': 'Emre', 'Initials': 'E', 'LastName': 'Mutlu', 'Affiliation': ''}, {'ForeName': 'Sertaç', 'Initials': 'S', 'LastName': 'Ak', 'Affiliation': ''}, {'ForeName': 'Esra', 'Initials': 'E', 'LastName': 'Akı', 'Affiliation': ''}, {'ForeName': 'A Elif', 'Initials': 'AE', 'LastName': 'Anıl Yağcıoğlu', 'Affiliation': ''}]",Turk psikiyatri dergisi = Turkish journal of psychiatry,[] 2283,32594511,Comparison of Nasal CPAP versus Bi-level CPAP in Transient Tachypnea of the Newborn: A Randomized Trial.,"OBJECTIVE The optimal noninvasive ventilation (NIV) modality in the treatment of transient tachypnea of the newborn (TTN) is still unknown. The aim of this study was to compare nasal continuous positive airway pressure (NCPAP) versus bi-level CPAP in the treatment of TTN. STUDY DESIGN This was a prospective randomized study that was conducted in a tertiary level neonatal intensive care unit of Zekai Tahir Burak Women's Health Education and Research Hospital during the 1-year period between April 2017 and March 2018. The study included infants at ≥34 gestational weeks and birth weight ≥2,000 g who were diagnosed with TTN. The patients were randomized to either NCPAP or bi-level CPAP groups as initial respiratory support. The primary outcome was the rate of NIV failure. RESULTS A total of 151 infants were incorporated into the study. The intubation rate was significantly higher in the NCPAP group (15/75) compared with the bi-level CPAP group (6/76) ( p  = 0.032). There was a significant decrease in the level of pCO 2 at the 12 (60.7 ± 6.7 vs. 66.3 ± 8.8, p  = 0.017) and 24 (50 ± 8 vs. 53 ± 10, p  = 0.028) hours of NIV in the bi-level CPAP group compared with the NCPAP group. Duration of NIV, total respiratory support, hospital stay, and the incidence of pneumothorax were similar between the groups. CONCLUSION Bi-level CPAP reduced the rate of NIV failure and pCO 2 levels at the 12 and 24 hours in late preterm and term infants with a diagnosis of TTN. KEY POINTS · Bi-level CPAP seems to be a safe and effective method in TTN.. · Bi-level CPAP may reduce the rate of NIV failure in late preterm and term infants with TTN.. · Future studies are warranted to answer the question whether bi-level CPAP might be used as a standard treatment in babies with TTN..",2020,The intubation rate was significantly higher in the NCPAP group (15/75) compared with the bi-level CPAP group (6/76) ( p  = 0.032).,"['151 infants', ""tertiary level neonatal intensive care unit of Zekai Tahir Burak Women's Health Education and Research Hospital during the 1-year period between April 2017 and March 2018"", 'infants at ≥34 gestational weeks and birth weight ≥2,000', 'transient tachypnea of the newborn (TTN', 'Transient Tachypnea of the Newborn']","['NCPAP or bi-level CPAP', 'NCPAP', 'noninvasive ventilation (NIV) modality', 'nasal continuous positive airway pressure (NCPAP) versus bi-level CPAP', 'Nasal CPAP versus Bi-level CPAP']","['intubation rate', 'rate of NIV failure and pCO 2 levels', 'Duration of NIV, total respiratory support, hospital stay, and the incidence of pneumothorax', 'rate of NIV failure', 'level of pCO']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021709', 'cui_str': 'Neonatal intensive care unit'}, {'cui': 'C0080339', 'cui_str': ""Woman's Health""}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0439671', 'cui_str': 'Gestational'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0005612', 'cui_str': 'Birth weight'}, {'cui': 'C0158940', 'cui_str': 'Transitory tachypnea of newborn'}, {'cui': 'C0231835', 'cui_str': 'Tachypnea'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}]","[{'cui': 'C1258045', 'cui_str': 'nCPAP Ventilation'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0199451', 'cui_str': 'Continuous positive airway pressure ventilation treatment'}, {'cui': 'C1997883', 'cui_str': 'Noninvasive ventilation'}, {'cui': 'C3665969', 'cui_str': 'Nasal CPAP'}]","[{'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C1997883', 'cui_str': 'Noninvasive ventilation'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0032460', 'cui_str': 'Polycystic ovary syndrome'}, {'cui': 'C0456948', 'cui_str': 'Level 2'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0032326', 'cui_str': 'Pneumothorax'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",151.0,0.0870603,The intubation rate was significantly higher in the NCPAP group (15/75) compared with the bi-level CPAP group (6/76) ( p  = 0.032).,"[{'ForeName': 'Buse', 'Initials': 'B', 'LastName': 'Özer Bekmez', 'Affiliation': 'Division of Neonatology, Ankara City Hospital, The University of Health Sciences, Ankara, Turkey.'}, {'ForeName': 'Evrim Alyamaç', 'Initials': 'EA', 'LastName': 'Dizdar', 'Affiliation': 'Division of Neonatology, Ankara City Hospital, The University of Health Sciences, Ankara, Turkey.'}, {'ForeName': 'Mehmet', 'Initials': 'M', 'LastName': 'Büyüktiryaki', 'Affiliation': 'Division of Neonatology, Ankara City Hospital, The University of Health Sciences, Ankara, Turkey.'}, {'ForeName': 'Fatmanur', 'Initials': 'F', 'LastName': 'Sari', 'Affiliation': 'Division of Neonatology, Ankara City Hospital, The University of Health Sciences, Ankara, Turkey.'}, {'ForeName': 'Nurdan', 'Initials': 'N', 'LastName': 'Uraş', 'Affiliation': 'Division of Neonatology, Ankara City Hospital, The University of Health Sciences, Ankara, Turkey.'}, {'ForeName': 'Fuat Emre', 'Initials': 'FE', 'LastName': 'Canpolat', 'Affiliation': 'Division of Neonatology, Ankara City Hospital, The University of Health Sciences, Ankara, Turkey.'}, {'ForeName': 'Şerife Suna', 'Initials': 'ŞS', 'LastName': 'Oğuz', 'Affiliation': 'Division of Neonatology, Ankara City Hospital, The University of Health Sciences, Ankara, Turkey.'}]",American journal of perinatology,['10.1055/s-0040-1713815'] 2284,32594522,"Efficacy and safety of risankizumab vs. secukinumab in patients with moderate-to-severe plaque psoriasis (IMMerge): Results from a phase 3, randomised, open-label, efficacy assessor-blinded clinical trial.","BACKGROUND Patients with plaque psoriasis treated with biologic therapies need more efficacious, safe, and convenient treatments to improve quality of life. Risankizumab and secukinumab inhibit interleukin (IL)-23 and IL-17A, respectively, and are effective in adult patients with moderate-to-severe plaque psoriasis but have different dosing regimens. OBJECTIVES Directly compare efficacy and safety of risankizumab vs. secukinumab over 52 weeks. METHODS IMMerge was an international, phase 3, multicentre, open-label, efficacy assessor-blinded, active-comparator study, in which adult patients with chronic, moderate-to-severe plaque psoriasis were randomised in a 1:1 ratio to treatment with risankizumab 150mg or secukinumab 300mg. Primary efficacy end points were proportions of patients achieving ≥90% improvement from baseline in Psoriasis Area Severity Index (PASI 90) at week 16 (noninferiority comparison with margin of 12%) and week 52 (superiority comparison). RESULTS A total of 327 patients from nine countries were treated with risankizumab (n=164) or secukinumab (n=163). Risankizumab was noninferior to secukinumab in proportion of patients achieving PASI 90 at week 16 [73∙8% vs. 65∙6%; difference of 8∙2% [96∙25% confidence interval (CI) -2∙2, 18∙6] within 12% noninferiority margin], and superior to secukinumab at week 52 [86∙6% vs. 57∙1%; difference of 29∙8% (95% CI 20∙8, 38∙8); P<0∙001], thus meeting both primary end points. All secondary end points (PASI 100, static Physician Global Assessment 0 or 1, and PASI 75) at week 52 demonstrated superiority for risankizumab vs. secukinumab (P<0∙001). No new safety concerns were identified. CONCLUSIONS At week 52, risankizumab demonstrated superior efficacy and similar safety with less frequent dosing compared with secukinumab.",2020,"Risankizumab was noninferior to secukinumab in proportion of patients achieving PASI 90 at week 16 [73∙8% vs. 65∙6%; difference of 8∙2% [96∙25% confidence interval (CI) -2∙2, 18∙6] within 12% noninferiority margin], and superior to secukinumab at week 52 [86∙6% vs. 57∙1%; difference of 29∙8% (95% CI 20∙8, 38∙8); P<0∙001], thus meeting both primary end points.","['adult patients with moderate-to-severe plaque psoriasis', 'patients with moderate-to-severe plaque psoriasis (IMMerge', '327 patients from nine countries', 'adult patients with chronic, moderate-to-severe plaque psoriasis', 'Patients with plaque psoriasis treated with']","['Risankizumab and secukinumab inhibit interleukin (IL)-23 and IL-17A', 'biologic therapies', 'risankizumab vs. secukinumab', 'risankizumab', 'risankizumab 150mg or secukinumab 300mg', 'secukinumab', 'Risankizumab']","['quality of life', 'points (PASI 100, static Physician Global Assessment 0 or 1, and PASI 75', 'Efficacy and safety', 'Psoriasis Area Severity Index (PASI 90']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0406317', 'cui_str': 'Chronic small plaque psoriasis'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C4505511', 'cui_str': 'risankizumab'}, {'cui': 'C3179547', 'cui_str': 'secukinumab'}, {'cui': 'C0963088', 'cui_str': 'IL-23'}, {'cui': 'C1701790', 'cui_str': 'IL17A protein, human'}, {'cui': 'C0005527', 'cui_str': 'Biotherapy'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C4319604', 'cui_str': '300'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C4324362', 'cui_str': 'Psoriasis area severity index'}]",327.0,0.270528,"Risankizumab was noninferior to secukinumab in proportion of patients achieving PASI 90 at week 16 [73∙8% vs. 65∙6%; difference of 8∙2% [96∙25% confidence interval (CI) -2∙2, 18∙6] within 12% noninferiority margin], and superior to secukinumab at week 52 [86∙6% vs. 57∙1%; difference of 29∙8% (95% CI 20∙8, 38∙8); P<0∙001], thus meeting both primary end points.","[{'ForeName': 'R B', 'Initials': 'RB', 'LastName': 'Warren', 'Affiliation': 'The Dermatology Centre, Salford Royal NHS Foundation Trust, Manchester NIHR Biomedical Research Centre, Manchester, U.K.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Blauvelt', 'Affiliation': 'Oregon Medical Research Centre, Portland, OR, U.S.A.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Poulin', 'Affiliation': 'Laval University and Centre de recherche dermatologique du Québec métropolitain, Québec City, Quebec, Canada.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Beeck', 'Affiliation': 'AbbVie Inc, North Chicago, IL, U.S.A.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Kelly', 'Affiliation': 'AbbVie Inc, North Chicago, IL, U.S.A.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Wu', 'Affiliation': 'AbbVie Inc, North Chicago, IL, U.S.A.'}, {'ForeName': 'Z', 'Initials': 'Z', 'LastName': 'Geng', 'Affiliation': 'AbbVie Inc, North Chicago, IL, U.S.A.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Paul', 'Affiliation': 'Paul Sabatier University and Larrey Hospital, Toulouse, France.'}]",The British journal of dermatology,['10.1111/bjd.19341'] 2285,32594615,"Reducing car idling at primary schools: an intervention study of parent behaviour change in Perth, Western Australia.","ISSUED ADDRESSED There is increasing evidence that exposure to traffic-related air pollution is related to childhood respiratory symptoms. This study demonstrated the effectiveness of an anti-idling behavioural intervention targeting parents at primary schools. METHODS Based on two focus group discussions with parents, a low-intensity four-week anti-idling intervention was developed, comprising onsite signage, four newsletters, and two fact sheets. Exposure to selected air pollutants was assessed during pick-up and drop- off times pre- and post-intervention at 12 randomly selected independent schools (10 intervention and 2 control) across the Perth metropolitan area. RESULTS The study results showed that a low-intensity behavioural intervention can be an effective strategy to affect parents' attitude towards vehicle idling. This was demonstrated by the reduced number of idling vehicles observed in 8 of the 10 intervention schools and decreased overall particulate matter concentration after the anti-idling intervention. CONCLUSION Anti-idling education can be effective in promoting clean travel behaviours and has potential health benefits for school children. SO WHAT?: This intervention study provides insights on the significant effect of anti-idling education on parents 'behaviour towards air quality and children's health. These promising findings warrant further rigorous actions on anti-idling education and enforcement.",2020,The study results showed that a low-intensity behavioural intervention can be an effective strategy to affect parents' attitude towards vehicle idling.,"[""parents 'behaviour towards air quality and children's health"", 'parents at primary schools', 'school children']","['anti-idling education', 'anti-idling behavioural intervention targeting']","['overall particulate matter concentration', 'reduced number of idling vehicles', 'clean travel behaviours']","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C2371710', 'cui_str': 'Air Quality'}, {'cui': 'C0008078', 'cui_str': 'Child health care'}, {'cui': 'C0033145', 'cui_str': 'Primary school'}, {'cui': 'C0260267', 'cui_str': 'School child'}]","[{'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1720884', 'cui_str': 'Particulate Matter'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0042444', 'cui_str': 'Drug vehicle'}, {'cui': 'C0402683', 'cui_str': 'Cleaner'}, {'cui': 'C0040802', 'cui_str': 'Travel'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",12.0,0.0255061,The study results showed that a low-intensity behavioural intervention can be an effective strategy to affect parents' attitude towards vehicle idling.,"[{'ForeName': 'Krassi', 'Initials': 'K', 'LastName': 'Rumchev', 'Affiliation': 'School of Public Health, Curtin University, Perth, Western, Australia.'}, {'ForeName': 'Andy', 'Initials': 'A', 'LastName': 'Lee', 'Affiliation': 'School of Public Health, Curtin University, Perth, Western, Australia.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Maycock', 'Affiliation': 'School of Public Health, Curtin University, Perth, Western, Australia.'}, {'ForeName': 'Jonine', 'Initials': 'J', 'LastName': 'Jancey', 'Affiliation': 'School of Public Health, Curtin University, Perth, Western, Australia.'}]",Health promotion journal of Australia : official journal of Australian Association of Health Promotion Professionals,['10.1002/hpja.381'] 2286,32594665,Effect of Education on Promoting Healthy Lifestyle Behaviors That Prevent Breast Cancer in Middle-Aged Women: Application of Protection Motivation Theory.,"Background In recent years, an increased incidence of breast cancer has made this disease the most common malignancy among Iranian women. Since education plays an important role in the implementation of preventive behaviors in breast cancer treatment, this study investigates the effect of educational interventions on the promotion of lifestyle-related behaviors that prevent breast cancer in middle-aged women. Methods In this randomized control study, 120 women referred to Neyshabur Health Services Centers were randomly selected and divided into two groups: an intervention group (60 subjects) and a control group (60 subjects). An educational intervention was carried out over five sessions, based on protective motivation theory constructs. Participants completed a researcher-designed questionnaire immediately and again 2 months after the intervention. The data were analyzed using IBM SPSS ver. 19.0 software (IBM Corp., Armonk, NY, USA). Results The results revealed a significant difference between the mean scores of participants exposed to protective motivation theory, awareness, and physical activities immediately and also 2 months after the intervention (P<0.05). Although the healthy diet scores of the two groups differed significantly immediately after the educational intervention (P<0.05), there was no significant difference between the groups 2 months after the intervention (P<0.05). Conclusion Given the effective role of education in protective motivation theory and the physical activity levels of the women who participated in this research, it seems clear that the women's financial status shaped their ability to consume more fruits and vegetables. As this social element impacts the health of individuals, training programs alone cannot succeed.",2020,"Although the healthy diet scores of the two groups differed significantly immediately after the educational intervention (P<0.05), there was no significant difference between the groups 2 months after the intervention (P<0.05). ","['middle-aged women', 'women who participated in this research', 'Middle-Aged Women', '120 women referred to Neyshabur Health Services Centers']","['Education', 'educational interventions']","['protective motivation theory, awareness, and physical activities', 'Healthy Lifestyle Behaviors', 'healthy diet scores']","[{'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0018747', 'cui_str': 'Services, Health'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C4277664', 'cui_str': 'Healthy Lifestyles'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0452415', 'cui_str': 'Healthy diet'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",120.0,0.0179883,"Although the healthy diet scores of the two groups differed significantly immediately after the educational intervention (P<0.05), there was no significant difference between the groups 2 months after the intervention (P<0.05). ","[{'ForeName': 'Zakieh Sadat', 'Initials': 'ZS', 'LastName': 'Hoseini', 'Affiliation': 'Department of Public Health, Neyshabur University of Medical Sciences, Neyshabur, Iran.'}, {'ForeName': 'Hamid Tavakoli', 'Initials': 'HT', 'LastName': 'Ghouchani', 'Affiliation': 'Department of Health Education and Promotion, School of Public Health, North Khorasan University of Medical Sciences, Bojnurd, Iran.'}, {'ForeName': 'Hamidreza Mohaddes', 'Initials': 'HM', 'LastName': 'Hakak', 'Affiliation': 'Department of Health Education and Promotion, School of Public Health, North Khorasan University of Medical Sciences, Bojnurd, Iran.'}, {'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Lashkardoost', 'Affiliation': 'Department of Biostatistics and Epidemiology, School of Public Health, North Khorasan University of Medical Sciences, Bojnurd, Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Mehri', 'Affiliation': 'Department of Health Education, School of Public Health, Sabzevar University of Medical Sciences, Sabzevar, Iran.'}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Khankolabi', 'Affiliation': 'Department of Health Education and Promotion, School of Public Health, North Khorasan University of Medical Sciences, Bojnurd, Iran.'}, {'ForeName': 'Elahe', 'Initials': 'E', 'LastName': 'Salari', 'Affiliation': 'Department of Nursing, School of Nursing and Midwifery, North Khorasan University of Medical Sciences, Bojnurd, Iran.'}]",Korean journal of family medicine,['10.4082/kjfm.19.0164'] 2287,32594675,[Triple Chronotherapy approach for reducing depressive symptoms and suicidal intent in hospitalized patients: Study protocol of a Randomized Controlled Trial].,"BACKGROUND Depressive disorders are a relevant burden for public health due to their prevalence and high levels of associated disability and mortality. Recent studies suggest that the combination of multiple chronotherapuetic interventions may reveal effective in the rapid improvement of depressive symptoms. OBJECTIVES This paper describes the protocol of a study that aims to test the efficacy of a triple chronotherapy intervention (combined total sleep deprivation, light therapy and sleep phase advance) in the improvement of depressive symptoms in individuals diagnosed with unipolar or bipolar depression. METHODS A randomized controlled trial will be conducted in patients hospitalized with a unipolar or bipolar depression at the Servizio Psichiatrico di Diagnosi e Cura inpatient unit of the San Paolo - ASST Santi Paolo e Carlo Hospital in Milan, Italy. Individuals will be randomly assigned to the intervention (triple chronotherapy add-on to standard pharmacological treatment) or to the ""control"" group (standard pharmacological treatment). RESULTS Enrolment began in December 2018 and will end in October 2020, or at any earlier point in which the expected sample size will be reached. The study protocol has already been approved by the local ethics committee and is registered as EudraCT 2019-000892-18. Outcome analyses aim to verify whether triple chronotherapy produces a rapid and stable improvement in depressive symptoms in individuals hospitalized for an acute unipolar or bipolar depressive episode.",2020,Outcome analyses aim to verify whether triple chronotherapy produces a rapid and stable improvement in depressive symptoms in individuals hospitalized for an acute unipolar or bipolar depressive episode.,"['individuals diagnosed with unipolar or bipolar depression', 'hospitalized patients', 'patients hospitalized with a unipolar or bipolar depression at the Servizio Psichiatrico di', 'individuals hospitalized for an acute unipolar or bipolar depressive episode', 'Diagnosi e Cura inpatient unit of the San Paolo - ASST Santi Paolo e Carlo Hospital in Milan, Italy']","['Triple Chronotherapy approach', 'intervention (triple chronotherapy add-on to standard pharmacological treatment) or to the ""control"" group (standard pharmacological treatment', 'triple chronotherapy intervention (combined total sleep deprivation, light therapy and sleep phase advance']","['depressive symptoms and suicidal intent', 'depressive symptoms']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0443340', 'cui_str': 'Unipolar'}, {'cui': 'C0005587', 'cui_str': 'Bipolar affective disorder, current episode depression'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0443156', 'cui_str': 'Bipolar'}, {'cui': 'C0349217', 'cui_str': 'Depressive episode, unspecified'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0445462', 'cui_str': 'Carlos'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0022277', 'cui_str': 'Italy'}]","[{'cui': 'C0205174', 'cui_str': 'Triple'}, {'cui': 'C0376626', 'cui_str': 'Chronotherapy'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0037316', 'cui_str': 'Sleep deprivation'}, {'cui': 'C0031765', 'cui_str': 'Light therapy'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0205390', 'cui_str': 'Phase'}]","[{'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0582496', 'cui_str': 'Suicidal intent'}]",,0.203961,Outcome analyses aim to verify whether triple chronotherapy produces a rapid and stable improvement in depressive symptoms in individuals hospitalized for an acute unipolar or bipolar depressive episode.,"[{'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Ferrara', 'Affiliation': 'Corso di Laurea in Infermieristica, ASST Santi Paolo e Carlo, Milano.'}, {'ForeName': 'Armando', 'Initials': 'A', 'LastName': ""D'Agostino"", 'Affiliation': 'Dipartimento di Scienze della Salute, Università degli Studi di Milano.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Terzoni', 'Affiliation': 'Corso di Laurea in Infermieristica, ASST Santi Paolo e Carlo, Milano.'}, {'ForeName': 'Edoardo Giuseppe', 'Initials': 'EG', 'LastName': 'Ostinelli', 'Affiliation': 'Dipartimento di Scienze della Salute, Università degli Studi di Milano.'}, {'ForeName': 'Simona', 'Initials': 'S', 'LastName': 'Cavallotti', 'Affiliation': 'Dipartimento di Salute Mentale, ASST Santi Paolo e Carlo, Milano.'}, {'ForeName': 'Clara', 'Initials': 'C', 'LastName': 'Basi', 'Affiliation': 'Dipartimento di Salute Mentale, ASST Santi Paolo e Carlo, Milano.'}, {'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'Bertino', 'Affiliation': 'Dipartimento di Scienze della Salute, Università degli Studi di Milano.'}, {'ForeName': 'Orsola', 'Initials': 'O', 'LastName': 'Gambini', 'Affiliation': 'Dipartimento di Scienze della Salute, Università degli Studi di Milano.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Destrebecq', 'Affiliation': 'Dipartimento di scienze biomediche per la salute, Università degli Studi di Milano.'}]",Professioni infermieristiche,['10.7429/pi.2020.731026'] 2288,32594702,[Effects of two dimensional gray-scale blood flow imaging combined with color Doppler flow imaging in guiding arterial puncture and catheterization through wounds in patients with large burns].,"Objective: To explore the effects of two dimensional gray-scale blood flow imaging (hereinafter referred to as "" B-flow"" ) combined with color Doppler flow imaging (CDFI) in guiding arterial puncture and catheterization through wounds in patients with large burns. Methods: Sixty-seven patients with large burns who met the inclusion criteria and hospitalized in the First Hospital of Jilin University from January 2017 to January 2019 were enrolled in the prospectively randomized control study. According to the random number table, CDFI alone group was allocated with 35 patients (23 males and 12 females) and B-flow+ CDFI group with 32 patients (22 males and 10 females), aged 19-60 and 18-58 years, respectively. According to the progress of the disease, arterial puncture and catheterization were performed in the right time. During the operation, CDFI was used alone for guidance in patients of CDFI alone group, while B-flow and CDFI were used together for guidance in patients of B-flow+ CDIF group. Based on the first time of catheterization, the catheterization location, one-time catheterization success rate, post-back stitching re-catheterization success rate, catheterization failure rate, catheterization duration, and incidences of wound sepsis, catheter-related bloodstream infection, and arterial thrombosis within post catheterization day (PCD) 3 of patients in the two groups were recorded. Data were statistically analyzed with the independent-sample t test, chi-square test or Fisher's exact probability test. Results: (1) All the patients underwent catheterization through wounds, and there was no statistically significant difference in catheterization location of patients between the two groups ( χ (2)=0.574, P >0.05). The one-time catheterization success rate of patients in B-flow+ CDFI group was 81.25% (26/32), which was obviously higher than 51.43% (18/35) in CDFI alone group ( χ (2)=6.594, P <0.05). The catheterization failure rate of patients in B-flow+ CDFI group was 3.12% (1/32), which was obviously lower than 20.00% (7/35) in CDFI alone group ( P <0.05). The post-back stitching re-catheterization success rate of patients was similar between the two groups ( χ (2)=1.029, P >0.05). (3) The catheterization duration of patients was (15.7±1.1) min in B-flow+ CDFI group, which was obviously shorter than (17.1±2.2) min in CDFI alone group ( t =11.316, P <0.01). (4) Within PCD 3, the incidences of wound sepsis and catheter-related bloodstream infection of patients in CDFI alone group were 2.86% (1/35) and 0, close to 0 and 3.12% (1/32) in B-flow+ CDFI group ( P >0.05); the incidence of arterial thrombosis of patients in B-flow+ CDFI group was 0, which was obviously lower than 20.00% (7/35) in CDFI alone group ( P <0.05). Conclusions: Compared with CDFI alone, B-flow combined with CDFI can improve the success rate of arterial puncture and catheterization through wounds in large area burn patients, shorten the catheterization duration, and effectively reduce the incidence of arterial thrombosis after catheterization, with a good clinical application value.",2020,", B-flow combined with CDFI can improve the success rate of arterial puncture and catheterization through wounds in large area burn patients, shorten the catheterization duration, and effectively reduce the incidence of arterial thrombosis after catheterization, with a good clinical application value.","['35 patients (23 males and 12 females) and B-flow+ CDFI group with 32 patients (22 males and 10 females), aged 19-60 and 18-58 years, respectively', 'Sixty-seven patients with large burns who met the inclusion criteria and hospitalized in the First Hospital of Jilin University from January 2017 to January 2019', 'patients with large burns']","['CDFI alone', 'CDFI', 'dimensional gray-scale blood flow imaging (hereinafter referred to as "" B-flow"" ) combined with color Doppler flow imaging (CDFI', 'dimensional gray-scale blood flow imaging combined with color Doppler flow imaging']","['incidence of arterial thrombosis', 'catheterization failure rate', 'incidences of wound sepsis and catheter-related bloodstream infection', 'time catheterization success rate', 'catheterization duration', 'catheterization location', 'catheterization location, one-time catheterization success rate, post-back stitching re-catheterization success rate, catheterization failure rate, catheterization duration, and incidences of wound sepsis, catheter-related bloodstream infection, and arterial thrombosis within post catheterization day (PCD', 'success rate of arterial puncture and catheterization']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517852', 'cui_str': '67'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0000912', 'cui_str': 'Accident caused by unspecified fire'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0041740', 'cui_str': 'University'}]","[{'cui': 'C0556636', 'cui_str': 'Gy'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0522507', 'cui_str': 'With color'}, {'cui': 'C0554756', 'cui_str': 'Doppler studies'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0151942', 'cui_str': 'Arterial thrombosis'}, {'cui': 'C0007430', 'cui_str': 'Catheterization'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C1141927', 'cui_str': 'Wound sepsis'}, {'cui': 'C2886794', 'cui_str': 'Catheter related bloodstream infection'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0450429', 'cui_str': 'Location'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0162638', 'cui_str': 'Apoptosis'}, {'cui': 'C0189586', 'cui_str': 'Puncture of artery'}]",67.0,0.0208289,", B-flow combined with CDFI can improve the success rate of arterial puncture and catheterization through wounds in large area burn patients, shorten the catheterization duration, and effectively reduce the incidence of arterial thrombosis after catheterization, with a good clinical application value.","[{'ForeName': 'D', 'Initials': 'D', 'LastName': 'Cai', 'Affiliation': 'Department of Burn Surgery, the First Hospital of Jilin University, Changchun 130021, China.'}, {'ForeName': 'W W', 'Initials': 'WW', 'LastName': 'Wu', 'Affiliation': 'Department of Burn Surgery, the First Hospital of Jilin University, Changchun 130021, China.'}, {'ForeName': 'D D', 'Initials': 'DD', 'LastName': 'Zhang', 'Affiliation': 'Department of Burn Surgery, the First Hospital of Jilin University, Changchun 130021, China.'}, {'ForeName': 'M Y', 'Initials': 'MY', 'LastName': 'Chi', 'Affiliation': 'Department of Burn Surgery, the First Hospital of Jilin University, Changchun 130021, China.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Ma', 'Affiliation': 'Department of Burn Surgery, the First Hospital of Jilin University, Changchun 130021, China.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Cheng', 'Affiliation': 'Department of Burn Surgery, the First Hospital of Jilin University, Changchun 130021, China.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'Department of Burn Surgery, the First Hospital of Jilin University, Changchun 130021, China.'}, {'ForeName': 'Q Y', 'Initials': 'QY', 'LastName': 'Zhao', 'Affiliation': 'Department of Burn Surgery, the First Hospital of Jilin University, Changchun 130021, China.'}]",Zhonghua shao shang za zhi = Zhonghua shaoshang zazhi = Chinese journal of burns,['10.3760/cma.j.cn501120-20190309-00099'] 2289,32598217,Laparoscopic Repair of Pediatric Inguinal Hernia: Disconnection of the Hernial Sac Versus Disconnection and Peritoneal Closure.,"Background/Purpose: Many techniques have been described for the treatment of pediatric inguinal hernia (PIH). Some authors emphasized the importance of disconnecting the sac, to create a scar, and to close the peritoneum mimicking the open approach. Others stated that peritoneal disconnection alone is enough for treatment of PIH regardless of the size of the internal ring. In this study, we compare the short-term results of laparoscopic disconnection of PIH sac versus disconnection and peritoneal closure. Patients and Methods: The study was carried from March 2016 to March 2017, on 34 patients with 40 PIH. Patients were randomly divided into two groups: group A, subjected to laparoscopic hernia sac disconnection and group B, subjected to laparoscopic hernia sac disconnection with peritoneal closure. Both groups were compared regarding the operative details, including complications and conversion, postoperative complications and recurrence. Results: Group A included 20 hernias in 15 patients, whereas group B included 20 hernias in 19 patients. The age ranged from 1 to 23 months. In group A, the mean operative time (OT) was 34.6 and 39.4 minutes, for unilateral and bilateral cases, respectively, whereas in group B, it was 45.1 minutes for unilateral cases and 65 minutes for 1 bilateral case. The OT was significantly shorter in group A for unilateral cases. There was no conversion and no intraoperative complications. Three recurrences occurred in group A (15% of hernias/20% of cases) with no recurrences in group B; difference was statistically insignificant. All 3 recurrences occurred in hernias with an internal ring diameter (IRD) >10 mm. Hospital stay was statistically shorter in group B. Conclusion: Both laparoscopic sac disconnection with internal ring closure and sac disconnection only are safe and effective treatments of PIH. However, the latter technique is not recommended for cases with IRD >10 mm because of the unacceptable high recurrence with rings >10 mm.",2020,All 3 recurrences occurred in hernias with an internal ring diameter (IRD),"['March 2016 to March 2017, on 34 patients with 40 PIH', 'Group A included 20 hernias in 15 patients, whereas group B included 20 hernias in 19 patients', 'pediatric inguinal hernia (PIH']","['laparoscopic disconnection of PIH sac versus disconnection and peritoneal closure', 'internal ring diameter (IRD', 'laparoscopic hernia sac disconnection and group B, subjected to laparoscopic hernia sac disconnection with peritoneal closure', 'Laparoscopic Repair of Pediatric Inguinal Hernia: Disconnection of the Hernial Sac Versus Disconnection and Peritoneal Closure', 'laparoscopic sac disconnection with internal ring closure and sac disconnection']","['OT', 'mean operative time (OT', 'no conversion and no intraoperative complications', 'Hospital stay', 'operative details, including complications and conversion, postoperative complications and recurrence']","[{'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0033373', 'cui_str': 'Prolactin inhibiting factor'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0019270', 'cui_str': 'Hernia'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0019294', 'cui_str': 'Inguinal hernia'}]","[{'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0033373', 'cui_str': 'Prolactin inhibiting factor'}, {'cui': 'C0031153', 'cui_str': 'Peritoneum (serous membrane) structure'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0521164', 'cui_str': 'Annular shape'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0333062', 'cui_str': 'Hernia sac'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0019294', 'cui_str': 'Inguinal hernia'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0439836', 'cui_str': 'Conversions'}, {'cui': 'C0021890', 'cui_str': 'Intraoperative complication'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}]",34.0,0.0206724,All 3 recurrences occurred in hernias with an internal ring diameter (IRD),"[{'ForeName': 'Akram Mohamed', 'Initials': 'AM', 'LastName': 'Elbatarny', 'Affiliation': 'Department of Pediatric Surgery, Faculty of Medicine, Tanta University, Tanta, Egypt.'}, {'ForeName': 'Mohammad G', 'Initials': 'MG', 'LastName': 'Khairallah', 'Affiliation': 'Department of Pediatric Surgery, Faculty of Medicine, Tanta University, Tanta, Egypt.'}, {'ForeName': 'Mostafa M', 'Initials': 'MM', 'LastName': 'Elsayed', 'Affiliation': 'Department of Pediatric Surgery, Faculty of Medicine, Tanta University, Tanta, Egypt.'}, {'ForeName': 'Amel A', 'Initials': 'AA', 'LastName': 'Hashish', 'Affiliation': 'Department of Pediatric Surgery, Faculty of Medicine, Tanta University, Tanta, Egypt.'}]",Journal of laparoendoscopic & advanced surgical techniques. Part A,['10.1089/lap.2018.0679'] 2290,32598231,"Effect of 12 Weeks of Endurance Training Combined with Creatine Supplement, Photobiomodulation Therapy, or Both on Performance and Muscle Damage in Rats.","Background: Photobiomodulation therapy (PBMT) and creatine (Cr) intake have been used in conjunction with heavy training, but little is known about their possible effects during a long-term training program. Objective: We assessed long-term use of PBMT and Cr in an exercise training program. Methods: Twenty-five male Wistar rats weighing ∼300 g were randomly allocated to one of five groups: a nontraining control group, a training group, a training group receiving Cr, a training group receiving PBMT, and a training group receiving both PBMT and Cr. The training program consisted of 12 weeks of daily swimming training. PBMT was delivered in six points with a laser device (808 nm, 100 mW, 30 s per point of irradiation, 3 J, 75 J/cm 2 ). Results: All training groups showed significantly higher peak force and longer time to 50% decay of force, and lower creatine kinase (CK) levels than the nontraining control group, thus confirming the benefit of the training program. In all outcomes related to muscle performance, the groups receiving PBMT with or without Cr supplement performed significantly better ( p  < 0.05) peak force and time of force decay during an electrical stimulation protocol than all the other groups. In addition, CK levels were also significantly lower for the PBMT groups than for the other groups. Conclusions: We conclude that PBMT alone or in conjunction with Cr supplement during a 12-week training program resulted in significantly better muscle performance and lower levels of CK, a biochemical marker of muscle damage.",2020,"All training groups showed significantly higher peak force and longer time to 50% decay of force, and lower creatine kinase (CK) levels than the nontraining control group, thus confirming the benefit of the training program.","['Twenty-five male Wistar rats weighing', 'Rats']","['Endurance Training Combined with Creatine Supplement, Photobiomodulation Therapy', 'daily swimming training', 'nontraining control group, a training group, a training group receiving Cr, a training group receiving PBMT, and a training group receiving both PBMT and Cr', 'PBMT', ': Photobiomodulation therapy (PBMT) and creatine (Cr) intake']","['muscle performance', 'peak force and time of force decay', 'peak force and longer time to 50% decay of force, and lower creatine kinase (CK) levels', 'CK levels', 'muscle performance and lower levels of CK, a biochemical marker of muscle damage']","[{'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0034716', 'cui_str': 'Wistar rat'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}]","[{'cui': 'C4704697', 'cui_str': 'Endurance Training'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0873188', 'cui_str': 'Creatine monohydrate'}, {'cui': 'C4019433', 'cui_str': 'Photobiomodulation Therapy'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0039003', 'cui_str': 'Swimming'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0010286', 'cui_str': 'Creatine'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}]","[{'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0860941', 'cui_str': 'Creatine low'}, {'cui': 'C0031727', 'cui_str': 'Kinase'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0206015', 'cui_str': 'Biochemical Markers'}, {'cui': 'C0410158', 'cui_str': 'Muscle damage NOS'}]",25.0,0.0210502,"All training groups showed significantly higher peak force and longer time to 50% decay of force, and lower creatine kinase (CK) levels than the nontraining control group, thus confirming the benefit of the training program.","[{'ForeName': 'Elvis de Souza', 'Initials': 'ES', 'LastName': 'Malta', 'Affiliation': 'Post-Graduate Program in Movement Sciences, Laboratory of Physiology and Sport Performance (LAFIDE), Department of Physical Education, São Paulo State University (UNESP), Bauru, Brazil.'}, {'ForeName': 'Cleber', 'Initials': 'C', 'LastName': 'Ferraresi', 'Affiliation': 'Post-Graduation Program in Biomedical Engineering, Universidade Brasil, São Paulo, Brazil.'}, {'ForeName': 'Marina Gaiato', 'Initials': 'MG', 'LastName': 'Monte', 'Affiliation': 'Post-Graduation Program in Pathophysiology in Medical Clinic, Medical School, UNESP, Botucatu, Brazil.'}, {'ForeName': 'Rodrigo Araujo Bonetti', 'Initials': 'RAB', 'LastName': 'de Poli', 'Affiliation': 'Post-Graduate Program in Movement Sciences, Laboratory of Physiology and Sport Performance (LAFIDE), Department of Physical Education, São Paulo State University (UNESP), Bauru, Brazil.'}, {'ForeName': 'Jan Magnus', 'Initials': 'JM', 'LastName': 'Bjordal', 'Affiliation': 'Physiotherapy Research Group, Department of Global Public Health and Primary Care, University of Bergen, Bergen, Norway.'}, {'ForeName': 'Rodrigo Álvaro Brandão', 'Initials': 'RÁB', 'LastName': 'Lopes-Martins', 'Affiliation': 'University of Vale do Paraíba (UNIVAP), Laboratory of Biophotonics and Experimental Therapeutics Institute of Research and Development, São José dos Campos, Brazil.'}, {'ForeName': 'Rodrigo Labat', 'Initials': 'RL', 'LastName': 'Marcos', 'Affiliation': 'UNINOVE-Applied Biophotonics Health Sciences, São Paulo, Brazil.'}, {'ForeName': 'Alessandro Moura', 'Initials': 'AM', 'LastName': 'Zagatto', 'Affiliation': 'Post-Graduate Program in Movement Sciences, Laboratory of Physiology and Sport Performance (LAFIDE), Department of Physical Education, São Paulo State University (UNESP), Bauru, Brazil.'}, {'ForeName': 'Rodrigo Leal de Paiva', 'Initials': 'RLP', 'LastName': 'Carvalho', 'Affiliation': 'Post-Graduate Program in Movement Sciences, Laboratory of Physiology and Sport Performance (LAFIDE), Department of Physical Education, São Paulo State University (UNESP), Bauru, Brazil.'}]","Photobiomodulation, photomedicine, and laser surgery",['10.1089/photob.2019.4793'] 2291,32598234,Acute Effects of Weighted Baseball Throwing Programs on Shoulder Range of Motion.,"BACKGROUND Baseball pitching injuries are increasing at an alarming rate. While weighted ball throwing programs may be effective at increasing pitching velocity, previous research has identified a 24% injury rate and a 3.3° increase in shoulder external rotation (ER) range of motion (ROM) after performing a 6-week program. However, previous research has not investigated, separately, the immediate effects of throwing underloaded and overloaded balls on ROM. The purpose of this study was to examine the acute effects of throwing differently weighted baseballs on shoulder ROM. By analyzing these differences, it may be possible to determine the specific weight range that may lead to the greatest increase in ROM and potential injury risk. HYPOTHESIS Throwing with weighted balls will result in an increase in shoulder ER ROM. STUDY DESIGN Randomized controlled trial. LEVEL OF EVIDENCE Level 2. METHODS A total of 16 male high school baseball pitchers agreed to participate in this study. The participants were (mean ± SD) 17.1 ± 1.0 years of age, 1.81 ± 0.09 m tall, and had a mass of 79.2 ± 11.1 kg. Each participant was tested on 3 different days, 1 week apart, with 3 different conditions in random order: (1) underload throwing, using regulation 5-oz baseballs and 4- and 2-oz balls; (2) overload throwing, using 5-, 6-, and 9-oz balls; and (3) extreme overload throwing, using 5-, 16-, and 32-oz balls. Each testing session began by measuring passive shoulder ROM (external rotation and internal rotation) using standard goniometric measurements. Participants then performed 3 throws with each weighted ball from 3 different positions (kneeling, rocker, and run-and-gun) for a total of 27 throws each test session. ROM measurements were repeated at the end of each test session. The effect of each throwing condition on ROM was compared from pre- to posttraining using a paired t test ( P ≤ 0.05). RESULTS There was no significant difference in ER after throwing at underloaded weights. The overload condition showed a statistically significant increase of 3.3° in external rotation ( P = 0.05). The extreme overload condition showed a statistically significant increase in ER of 8.4° ( P < 0.001). There were no differences in internal rotation for any group. CONCLUSION A significant increase in shoulder ER was observed immediately after throwing overload weighted balls. This effect increased as the weights of the balls increased. CLINICAL RELEVANCE Throwing with overload weighted baseballs causes an immediate increase in shoulder ER ROM. It is unknown why these changes occur; however, the results may explain both the increase in velocity and injury rates previously observed from throwing weighted balls. The current study results may be used to develop more scientifically validated weighted ball programs. Heavier balls should be used with caution, and ROM should be monitored during implementation of these programs.",2020,The overload condition showed a statistically significant increase of 3.3° in external rotation ( P = 0.05).,"['16 male high school baseball pitchers', 'The participants were (mean ± SD) 17.1 ± 1.0 years of age, 1.81 ± 0.09 m tall, and had a mass of 79.2 ± 11.1 kg']","['Weighted Baseball Throwing Programs', 'underload throwing, using regulation 5-oz baseballs and 4- and 2-oz balls; (2) overload throwing, using 5-, 6-, and 9-oz balls; and (3) extreme overload throwing, using 5-, 16-, and 32-oz balls']","['ROM', 'shoulder external rotation (ER) range of motion (ROM', 'weights of the balls increased', 'internal rotation', 'external rotation', 'Shoulder Range of Motion', 'ER', 'velocity and injury rates', 'shoulder ER ROM', 'shoulder ER', 'ROM measurements']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0004795', 'cui_str': 'Baseball'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517419', 'cui_str': '0.09'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0004795', 'cui_str': 'Baseball'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0039597', 'cui_str': 'Testis structure'}, {'cui': 'C0205403', 'cui_str': 'Extreme'}]","[{'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0231462', 'cui_str': 'External rotation'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0039597', 'cui_str': 'Testis structure'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0231459', 'cui_str': 'Internal rotation'}, {'cui': 'C0575545', 'cui_str': 'Shoulder joint - range of movement'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}]",16.0,0.0570077,The overload condition showed a statistically significant increase of 3.3° in external rotation ( P = 0.05).,"[{'ForeName': 'Michael M', 'Initials': 'MM', 'LastName': 'Reinold', 'Affiliation': 'Champion PT and Performance, Waltham, Massachusetts.'}, {'ForeName': 'Leonard C', 'Initials': 'LC', 'LastName': 'Macrina', 'Affiliation': 'Champion PT and Performance, Waltham, Massachusetts.'}, {'ForeName': 'Glenn S', 'Initials': 'GS', 'LastName': 'Fleisig', 'Affiliation': 'American Sports Medicine Institute, Birmingham, Alabama.'}, {'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Drogosz', 'Affiliation': 'American Sports Medicine Institute, Birmingham, Alabama.'}, {'ForeName': 'James R', 'Initials': 'JR', 'LastName': 'Andrews', 'Affiliation': 'Andrews Sports Medicine and Orthopaedic Center, Birmingham, Alabama.'}]",Sports health,['10.1177/1941738120925728'] 2292,32598255,Pitavastatin Combined with Ezetimibe Treatment was an Effective Approach to Non-IRA Lesion of ST-segment Elevation Myocardial Infarc-tion Patients with Primary Percutaneous Coronary Intervention.,"OBJECTIVE ST-segment elevation myocardial infarction (STEMI) patients with the multivessel disease have distinctive plaque characteristics in non-IRA lesions. Intensive statin therapy was a potential approach to treat STEMI patients with the non-IRA disease. However, there is still poor evidence about the therapeutic effect. In this study, we have evaluated the detailed therapeutic effect of statin plus ezetimibe intensive therapy. METHOD For STEMI patients with non-IRA disease undergoing primary percutaneous coronary intervention (PCI), 183 control STEMI patients without non-IRA disease undergoing primary PCI, and 200 STEMI patients with non-IRA disease undergoing primary PCI were introduced into this study. 200 STEMI patients with non-IRA disease undergoing primary PCI were divided into Normal group, Intensive group, Normal & Combined group, and Intensive & Combined group. The baseline information for each participant was recorded. Meanwhile, the physiological and biochemical indicators of each member with different treatments were collected after one-year follow-up. RESULT For STEMI patients with non-IRA disease undergoing primary PCI, no differences could be detected in multiple indexes such as OCT examination results, age, stroke, etc. However, diabetes mellitus, smoking, and coronary Gensini score were different between different groups (P<0.05). After one year follow-up, cholesterol, low-density lipoprotein, coronary Gensini score, thin-cap fibroatheroma, length of non-infarcted arterial lesions, non-infarct artery lesion range, myocardial infarction again, and revascularization again were significantly different between different groups (P<0.05). CONCLUSION The results mentioned above suggested that pitavastatin combined with ezetimibe was an effective approach to STEMI patients with non-IRA disease undergoing primary PCI. The results obtained in this study have provided a novel way for the treatment of STEMI patients with non-IRA disease undergoing primary PCI.",2020,"After one year follow-up, cholesterol, low-density lipoprotein, coronary Gensini score, thin-cap fibroatheroma, length of non-infarcted arterial lesions, non-infarct artery lesion range, myocardial infarction again, and revascularization again were significantly different between different groups (P<0.05). ","['200 STEMI patients with non-IRA disease undergoing primary PCI', 'For STEMI patients with non-IRA disease undergoing primary PCI', 'STEMI patients with the non-IRA disease', 'STEMI patients with non-IRA disease undergoing primary PCI', 'For STEMI patients with non-IRA disease undergoing primary percutaneous coronary intervention (PCI', '183 control STEMI patients without non-IRA disease undergoing primary PCI, and 200 STEMI patients with non-IRA disease undergoing primary PCI']","['pitavastatin', 'Pitavastatin Combined with Ezetimibe', 'ezetimibe', 'Intensive statin therapy', 'Intensive group, Normal & Combined group, and Intensive & Combined group', 'statin plus ezetimibe']","['diabetes mellitus, smoking, and coronary Gensini score', 'cholesterol, low-density lipoprotein, coronary Gensini score, thin-cap fibroatheroma, length of non-infarcted arterial lesions, non-infarct artery lesion range, myocardial infarction again, and revascularization again']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0441635', 'cui_str': 'Segment'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C4517615', 'cui_str': '183'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C1101838', 'cui_str': 'pitavastatin'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C1142985', 'cui_str': 'ezetimibe'}, {'cui': 'C1278454', 'cui_str': 'Statin prophylaxis'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0023823', 'cui_str': 'Low density lipoprotein'}, {'cui': 'C0205168', 'cui_str': 'Thin'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C2936351', 'cui_str': 'Fibroatheromatous Plaques'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0021308', 'cui_str': 'Infarct'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}]",200.0,0.0205298,"After one year follow-up, cholesterol, low-density lipoprotein, coronary Gensini score, thin-cap fibroatheroma, length of non-infarcted arterial lesions, non-infarct artery lesion range, myocardial infarction again, and revascularization again were significantly different between different groups (P<0.05). ","[{'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Zhao', 'Affiliation': 'Department of Cardiology, Beijing Shijitan Hospital, Capital Medical University, Beijing. China.'}, {'ForeName': 'Guang Ping', 'Initials': 'GP', 'LastName': 'Li', 'Affiliation': 'Department of Cardiology, Beijing Shijitan Hospital, Capital Medical University, Beijing. China.'}, {'ForeName': 'Jian Jun', 'Initials': 'JJ', 'LastName': 'Peng', 'Affiliation': 'Department of Cardiology, Beijing Shijitan Hospital, Capital Medical University, Beijing. China.'}, {'ForeName': 'Li Hui', 'Initials': 'LH', 'LastName': 'Ren', 'Affiliation': 'Department of Cardiology, Beijing Shijitan Hospital, Capital Medical University, Beijing. China.'}, {'ForeName': 'Li Cheng', 'Initials': 'LC', 'LastName': 'Lei', 'Affiliation': 'Department of Cardiology, Beijing Shijitan Hospital, Capital Medical University, Beijing. China.'}, {'ForeName': 'Hui Ming', 'Initials': 'HM', 'LastName': 'Ye', 'Affiliation': 'Department of Cardiology, Beijing Shijitan Hospital, Capital Medical University, Beijing. China.'}, {'ForeName': 'Zuo Yan', 'Initials': 'ZY', 'LastName': 'Wang', 'Affiliation': 'Department of Cardiology, Beijing Shijitan Hospital, Capital Medical University, Beijing. China.'}, {'ForeName': 'Sheng', 'Initials': 'S', 'LastName': 'Zhao', 'Affiliation': 'Department of Cardiology, Beijing Shijitan Hospital, Capital Medical University, Beijing. China.'}]",Current pharmaceutical biotechnology,['10.2174/1389201021666200629153421'] 2293,32598257,"Selinexor (KPT-330), an Oral Selective Inhibitor of Nuclear Export (SINE) Compound, in Combination with FOLFOX in Patients with Metastatic Colorectal Cancer (mCRC) - Final Results of the Phase I Trial SENTINEL.","BACKGROUND Selinexor is an oral Selective Inhibitor of Nuclear Export compound that specifically blocks Chromosomal Region Maintenance protein 1. OBJECTIVE To evaluate the safety and tolerability of escalating doses of selinexor plus 5-fluorouracil, leucovorin and oxaliplatin (mFOLFOX6) in metastatic colorectal cancer (mCRC) patients. METHODS In this multicenter phase I trial, mCRC patients, eligible for oxaliplatin-based treatment, were enrolled to receive oral selinexor on days 1, 3, and 8 plus mFOLFOX6 every two weeks. Primary endpoint was the maximum tolerated dose. Secondary endpoints were toxicity, overall response rate, progression free survival, and overall survival. RESULTS Overall, 10 patients were enrolled, who had prior treatment with oxaliplatin (6/10), irinotecan (8/10), bevacizumab (6/10) or anti-EGFR therapy (5/10). Four consecutive patients received 40 mg selinexor plus mFOLFOX6. All four experienced dose-limiting toxicities and withdrew from the study after a median of two cycles. Thus, this dose level was regarded as toxic and no further patients were evaluated at this dose. Six patients were enrolled with 20 mg selinexor plus mFOLFOX6. Despite better tolerability, four patients withdrew (patient wish) after the first cycle and only two patients continued until disease progression. Most commonly reported treatment emergent adverse events were nausea (80%), diarrhea (70%), vomiting (60%), fatigue (60%), anorexia (40%), and impaired vision (40%). Due to the short treatment exposure, no relevant clinical activity was observed. CONCLUSION In patients with metastatic colorectal cancer, selinexor on this dose schedule plus mFOLFOX6 was not tolerable. Other dosing schedules or combinations may be evaluated. Clinical trial identifier NCT02384850.",2020,"Secondary endpoints were toxicity, overall response rate, progression free survival, and overall survival. ","['patients with metastatic colorectal cancer', 'mCRC patients, eligible for oxaliplatin-based treatment', 'metastatic colorectal cancer (mCRC) patients', '10 patients were enrolled, who had prior treatment with', 'Six patients were enrolled with 20 mg', 'Patients with Metastatic Colorectal Cancer (mCRC']","['40 mg selinexor plus mFOLFOX6', 'oxaliplatin', 'Selinexor (KPT-330), an Oral Selective Inhibitor of Nuclear Export ', 'bevacizumab (6/10) or anti-EGFR therapy', 'selinexor plus 5-fluorouracil, leucovorin and oxaliplatin (mFOLFOX6', 'selinexor plus mFOLFOX6', 'FOLFOX', 'irinotecan', 'oral selinexor']","['diarrhea', 'anorexia', 'fatigue', 'toxicity, overall response rate, progression free survival, and overall survival', 'safety and tolerability', 'vomiting', 'nausea', 'maximum tolerated dose', 'impaired vision']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4721579', 'cui_str': 'Secondary malignant neoplasm of colon and/or rectum'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332152', 'cui_str': 'Before'}]","[{'cui': 'C3852671', 'cui_str': 'Selinexor'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C3640806', 'cui_str': 'KPT-330'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0887840', 'cui_str': 'Nuclear Export'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0023413', 'cui_str': 'Leucovorin'}, {'cui': 'C0123931', 'cui_str': 'irinotecan'}]","[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0003123', 'cui_str': 'Anorexia'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0752079', 'cui_str': 'Maximal Tolerated Dose'}, {'cui': 'C3665347', 'cui_str': 'Visual impairment'}]",4.0,0.0785983,"Secondary endpoints were toxicity, overall response rate, progression free survival, and overall survival. ","[{'ForeName': 'Sven', 'Initials': 'S', 'LastName': 'Nilsson', 'Affiliation': 'II. Medical Clinic and Polyclinic, University Medical Center Hamburg-Eppendorf, Hamburg. Germany.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Stein', 'Affiliation': 'II. Medical Clinic and Polyclinic, University Medical Center Hamburg-Eppendorf, Hamburg. Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Rolfo', 'Affiliation': 'Phase I- Early Clinical Trials Unit, Antwerp University Hospital, Edegem. Belgium.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Kranich', 'Affiliation': '5GSO Global Clinical Research B.V., Amsterdam. Netherlands.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Mann', 'Affiliation': 'II. Medical Clinic and Polyclinic, University Medical Center Hamburg-Eppendorf, Hamburg. Germany.'}, {'ForeName': 'Konstantinos', 'Initials': 'K', 'LastName': 'Papadimitriou', 'Affiliation': 'Phase I- Early Clinical Trials Unit, Antwerp University Hospital, Edegem. Belgium.'}, {'ForeName': 'Susann', 'Initials': 'S', 'LastName': 'Theile', 'Affiliation': 'GSO Gesellschaft für Studienmanagement und Onkologie mbH, Hamburg. Germany.'}, {'ForeName': 'Stefanie', 'Initials': 'S', 'LastName': 'Amberg', 'Affiliation': 'GSO Gesellschaft für Studienmanagement und Onkologie mbH, Hamburg. Germany.'}, {'ForeName': 'Carsten', 'Initials': 'C', 'LastName': 'Bokemeyer', 'Affiliation': 'II. Medical Clinic and Polyclinic, University Medical Center Hamburg-Eppendorf, Hamburg. Germany.'}]",Current cancer drug targets,['10.2174/1568009620666200628105727'] 2294,32598387,Bleeding profile of women using a drospirenone-only pill 4 mg over nine cycles in comparison with desogestrel 0.075 mg.,"BACKGROUND Progestin-only pills are associated with irregular bleeding pattern including amenorrhea. Desogestrel 75mcg even being a pill that inhibits ovulation shows a poor cycle control that limits a more common use. A drospirenone (DRSP)-only pill was developed to improve the bleeding profile. METHODS A phase III study in healthy women aged 18 to 45 years was performed to compare the bleeding profile and safety of women taking a DRSP only pill in a regime of 24 days of 4 mg of DRSP tablets followed by 4 days of placebo versus desogestrel 0.075 mg per day continuously over 9 cycles. A total of 858 women with 6691 drospirenone and 332 women with 2487 desogestrel treatment cycles were analyzed. The primary endpoint was the proportion of women with bleeding/spotting days in each cycle from cycles 2 to 9 and cumulative in cycles 2 to 4 and cycles 7 to 9 including and excluding those with amenorrhea. FINDINGS In each cycle, up to cycle 7, the proportion of women with unscheduled bleeding including those which did not bleed was statistically significantly lower in the DRSP group than in the DSG group (p = 0.0001, chi-square test). The mean [SD] number of unscheduled bleeding and spotting days during cycles 2-9 was statistically significantly lower in the DRSP group than in the DSG group (21.5 [22.86] days vs. 34.7 [33.73] days, p = 0.0003, Wilcoxon-rank-sum-test). Excluding amenorrhoeic women following results were obtained: In the cycles 2-6, the proportion of women with unscheduled bleeding was statistically significantly lower in the DRSP group than in the DSG group (p = 0.0001, chi-square test). The mean [SD] number of bleeding days was 8.6 [8.52] days vs. 12.9 [16.47] days, p = 0.0233. CONCLUSIONS This report describes the improvement in bleeding profile of women using the new DRSP only oral contraceptive in comparison to DSG providing a better quality of live and adherence to the contraceptive method. EudraCT registration number: 2011-002396-42.",2020,"In the cycles 2-6, the proportion of women with unscheduled bleeding was statistically significantly lower in the DRSP group than in the DSG group (p = 0.0001, chi-square test).","['858 women with 6691 drospirenone and 332 women with 2487 desogestrel treatment cycles were analyzed', 'healthy women aged 18 to 45 years', 'Excluding amenorrhoeic women following results were obtained']","['DRSP', 'placebo versus desogestrel', 'drospirenone (DRSP)-only pill', 'drospirenone', 'DRSP tablets', 'Desogestrel']","['mean [SD] number of bleeding days', 'proportion of women with unscheduled bleeding', 'bleeding profile and safety', 'quality of live and adherence', 'bleeding profile', 'proportion of women with bleeding/spotting days', 'proportion of women with unscheduled bleeding including those which did not bleed', 'mean [SD] number of unscheduled bleeding and spotting days']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0043822', 'cui_str': 'drospirenone'}, {'cui': 'C0057558', 'cui_str': 'Desogestrel'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}]","[{'cui': 'C0043822', 'cui_str': 'drospirenone'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0057558', 'cui_str': 'Desogestrel'}, {'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C3854240', 'cui_str': 'Unscheduled'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0015230', 'cui_str': 'Eruption'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1299585', 'cui_str': 'Does not'}]",858.0,0.0815399,"In the cycles 2-6, the proportion of women with unscheduled bleeding was statistically significantly lower in the DRSP group than in the DSG group (p = 0.0001, chi-square test).","[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Palacios', 'Affiliation': 'Salud y Medicina de la Mujer, Director-Instituto Palacios, Madrid, Spain.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Colli', 'Affiliation': 'Exeltis HealthCare Madrid, Madrid, Spain.'}, {'ForeName': 'P A', 'Initials': 'PA', 'LastName': 'Regidor', 'Affiliation': 'Exeltis Europe, Ismaning, Germany.'}]",PloS one,['10.1371/journal.pone.0231856'] 2295,32598397,Profiling the health-related physical fitness of Irish adolescents: A school-level sociodemographic divide.,"BACKGROUND AND AIMS Examining factors that may explain disparities in fitness levels among youth is a critical step in youth fitness promotion. The purpose of this study was twofold; 1) to examine the influence of school-level characteristics on fitness test performance; 2) to compare Irish adolescents' physical fitness to European norms. METHODS Adolescents (n = 1215, girls = 609) aged 13.4 years (SD .41) from a randomised sample of 20 secondary schools, stratified for gender, location and educational (dis)advantage, completed a series of field-based tests to measure the components of health-related physical fitness. Tests included: body mass index; 20 metre shuttle run test (20 m SRT); handgrip strength; standing broad jump (SBJ); 4 x 10 metre shuttle run; and back-saver sit-and-reach (BSR). RESULTS Overall, boys outperformed girls in all tests, aside from the BSR (p < 0.005, t-test, Bonferroni correction). Participants in designated disadvantaged schools had significantly higher body mass index levels (p < 0.001), and significantly lower cardiorespiratory endurance (20 m SRT) (p < 0.001) and muscular strength (handgrip strength) (p = 0.018) levels compared to participants in non-disadvantaged schools. When compared to European norms, girls in this study scored significantly higher in the 20 m SRT, 4 x 10 metre shuttle run and SBJ tests, while boys scored significantly higher in the BSR test (Cohen's d 0.2 to 0.6, p < 0.001). However, European adolescents had significantly higher handgrip strength scores (Cohen's d 0.6 to 0.8, p < 0.001). CONCLUSION Irish adolescents compared favourably to European normative values across most components of HRPF, with the exception of muscular strength. School socioeconomic status was a strong determinant of performance among Irish adolescents. The contrasting findings for different fitness components reiterate the need for multi-component testing batteries for monitoring fitness in youth.",2020,"Overall, boys outperformed girls in all tests, aside from the BSR (p < 0.005, t-test, Bonferroni correction).","[""Irish adolescents' physical fitness to European norms"", 'Irish adolescents', 'Adolescents (n = 1215, girls = 609) aged 13.4 years (SD .41) from a randomised sample of 20 secondary schools, stratified for gender, location and educational (dis)advantage, completed a series of field-based tests to measure the components of health-related physical fitness']",[],"['handgrip strength scores', 'muscular strength (handgrip strength', 'cardiorespiratory endurance', 'body mass index; 20 metre shuttle run test (20 m SRT); handgrip strength; standing broad jump (SBJ); 4 x 10 metre shuttle run; and back-saver sit-and-reach (BSR', 'body mass index levels', 'BSR test']","[{'cui': 'C1553352', 'cui_str': 'Irish Gaelic language'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0237750', 'cui_str': 'Societal Norms'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517558', 'cui_str': '13.4'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0036530', 'cui_str': 'Secondary school'}, {'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0450429', 'cui_str': 'Location'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205549', 'cui_str': 'Series'}, {'cui': 'C0440042', 'cui_str': ""Field's stain""}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0018684', 'cui_str': 'Health'}]",[],"[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0442025', 'cui_str': 'Muscular'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0475209', 'cui_str': 'meter'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0234742', 'cui_str': 'Speech reception threshold'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0332464', 'cui_str': 'Widening'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",1215.0,0.0397272,"Overall, boys outperformed girls in all tests, aside from the BSR (p < 0.005, t-test, Bonferroni correction).","[{'ForeName': 'Brendan T', 'Initials': 'BT', 'LastName': ""O'Keeffe"", 'Affiliation': 'Department of Physical Education and Sport Sciences, University of Limerick, Limerick, Ireland.'}, {'ForeName': 'Ciaran', 'Initials': 'C', 'LastName': 'MacDonncha', 'Affiliation': 'Department of Physical Education and Sport Sciences, University of Limerick, Limerick, Ireland.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Purtill', 'Affiliation': 'Health Research Institute, University of Limerick, Limerick, Ireland.'}, {'ForeName': 'Alan E', 'Initials': 'AE', 'LastName': 'Donnelly', 'Affiliation': 'Department of Physical Education and Sport Sciences, University of Limerick, Limerick, Ireland.'}]",PloS one,['10.1371/journal.pone.0235293'] 2296,32598445,"Effects of Fortetropin® on the rate of muscle protein synthesis in older men and women: a randomized, double-blinded, placebo-controlled study.","BACKGROUND Fortetropin is a proteo-lipid complex made from fertilized egg yolk and, in young men, has been shown to increase lean body mass. METHODS The purpose of this study was to examine the effects of 21 days of Fortetropin supplementation on the fractional rate of muscle protein synthesis (FSR) in 10 healthy, older men and 10 women (66.4 ± 4.5 yr.). We used 2H2O labeling to measure FSR of multiple muscle protein ontologies. D3-creatine dilution was used to determine muscle mass at baseline. Subjects ingested 70% 2H2O for 21 day and saliva samples were collected to determine body 2H2O enrichment. A microbiopsy was obtained from the m. vastus lateralis on day 21. Subjects were randomly assigned to Fortetropin (19.8 g/d) or placebo (cheese powder, 19.8 g/d). RESULTS Restricting kinetic data to proteins with ≥ 2 peptides measured in at least 4 subjects per group resulted in 117 proteins meeting these criteria. The mean FSR for a majority of proteins in several muscle gene ontologies was higher in the Fortetropin group compared to placebo (32/38 myofibril proteins, 33/44 sarcoplasmic proteins and 12/17 mitochondrial proteins) and this proportion was significantly different between groups using a binomial test and were independent of sex or baseline muscle mass. CONCLUSIONS The overall magnitude of the difference in muscle protein FSR of Fortetropin from placebo was 18%, with multiple gene ontologies affected. While these results should be confirmed in larger cohorts, they suggest that Fortetropin supplementation is effective for promoting muscle protein synthesis in older people.",2020,"The mean FSR for a majority of proteins in several muscle gene ontologies was higher in the Fortetropin group compared to placebo (32/38 myofibril proteins, 33/44 sarcoplasmic proteins and 12/17 mitochondrial proteins) and this proportion was significantly different between groups using a binomial test and were independent of sex or baseline muscle mass. ","['older people', '10 healthy, older men and 10 women (66.4 ± 4.5 yr', 'young men', 'older men and women']","['placebo', 'Fortetropin supplementation', 'Fortetropin', 'Fortetropin®']","['fractional rate of muscle protein synthesis (FSR', 'rate of muscle protein synthesis', 'muscle protein FSR of Fortetropin', 'mean FSR']","[{'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C3844009', 'cui_str': '4.5'}, {'cui': 'C0332239', 'cui_str': 'Young'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0026832', 'cui_str': 'Muscle Protein'}, {'cui': 'C0220781', 'cui_str': 'Anabolism'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",117.0,0.322924,"The mean FSR for a majority of proteins in several muscle gene ontologies was higher in the Fortetropin group compared to placebo (32/38 myofibril proteins, 33/44 sarcoplasmic proteins and 12/17 mitochondrial proteins) and this proportion was significantly different between groups using a binomial test and were independent of sex or baseline muscle mass. ","[{'ForeName': 'William', 'Initials': 'W', 'LastName': 'Evans', 'Affiliation': 'Department of Nutritional Sciences and Toxicology, University of California Berkeley.'}, {'ForeName': 'Mahalakshmi', 'Initials': 'M', 'LastName': 'Shankaran', 'Affiliation': 'Department of Nutritional Sciences and Toxicology, University of California Berkeley.'}, {'ForeName': 'Edna', 'Initials': 'E', 'LastName': 'Nyangau', 'Affiliation': 'Department of Nutritional Sciences and Toxicology, University of California Berkeley.'}, {'ForeName': 'Tyler', 'Initials': 'T', 'LastName': 'Field', 'Affiliation': 'Department of Nutritional Sciences and Toxicology, University of California Berkeley.'}, {'ForeName': 'Mohammed', 'Initials': 'M', 'LastName': 'Hussein', 'Affiliation': 'Department of Nutritional Sciences and Toxicology, University of California Berkeley.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Wolfe', 'Affiliation': 'Departement of Geriatrics, University of Arkansas for Medical Sciences.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Schutzler', 'Affiliation': 'Departement of Geriatrics, University of Arkansas for Medical Sciences.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Hellerstein', 'Affiliation': 'Department of Nutritional Sciences and Toxicology, University of California Berkeley.'}]","The journals of gerontology. Series A, Biological sciences and medical sciences",['10.1093/gerona/glaa162'] 2297,32598630,[Treatment of influenza and other acute respiratory viral infections in patients with diabetes mellitus].,"PURPOSE OF THE STUDY The study of the influenza and ARVI clinical performance, the development of patients with diabetes mellitus, evaluation of the effectiveness and safety application of antiviral therapy, carried out in the framework of routine clinical practice. MATERIALS AND METHODS 126 patients aged from 22 to 83 years (27.8% of men) with ARVI or influenza that occurred with medical care during the first 5 days of the disease (60.3% in the first 48 hours) are included. All patients suffer from diabetes, for the treatment of which oral hypoglycemic agents or insulins were constantly taken. The patients were divided into two groups: the first group received standard symptomatic treatment of ARVI; antiviral drug Kagocel. RESULTS AND CONCLUSION Diabetes and other acute respiratory viral infections. There is an increase in the incidence of bacterial complications - 2.2 times, an increase in the frequency of systemic antibiotics - 2.3 times. The purpose of the drug prescription led to a more rapid regression of all the symptoms of influenza and ARVI, but the most striking positive dynamics was observed in the symptoms of general weakness and headache. The prescription of Kagocel was accompanied by a 58% reduction in the number of bacterial complications and a 53% reduction in the use of antibiotics, which led to a reduction in the number of cases of the disease and an improvement in initial diseases, with an frequency increase in 1.8 times. The most significant effect achieved with early treatment and early initiation of antiviral therapy (in the first 48 hours of the disease).",2019,"There is an increase in the incidence of bacterial complications - 2.2 times, an increase in the frequency of systemic antibiotics - 2.3 times.","['126 patients aged from 22 to 83 years (27.8% of men) with ARVI or influenza that occurred with medical care during the first 5 days of the disease (60.3% in the first 48 hours) are included', 'patients with diabetes mellitus', 'All patients suffer from diabetes, for the treatment of which oral hypoglycemic agents or insulins were constantly taken']",['standard symptomatic treatment of ARVI; antiviral drug Kagocel'],"['early initiation of antiviral therapy', 'number of bacterial complications']","[{'cui': 'C0470256', 'cui_str': '126'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0021400', 'cui_str': 'Influenza'}, {'cui': 'C2745955', 'cui_str': 'Occurrence'}, {'cui': 'C0496675', 'cui_str': 'Medical care'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439586', 'cui_str': '48 hours'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0020616', 'cui_str': 'Hypoglycemic agent'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C1515187', 'cui_str': 'Take'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0003451', 'cui_str': 'Antiviral'}]","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C0280274', 'cui_str': 'Antiviral therapy'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",126.0,0.0171877,"There is an increase in the incidence of bacterial complications - 2.2 times, an increase in the frequency of systemic antibiotics - 2.3 times.","[{'ForeName': 'I G', 'Initials': 'IG', 'LastName': 'Sitnikov', 'Affiliation': 'Yaroslavl State Medical University.'}, {'ForeName': 'V K', 'Initials': 'VK', 'LastName': 'Fazylov', 'Affiliation': 'Kazan State Medical University.'}, {'ForeName': 'E V', 'Initials': 'EV', 'LastName': 'Silina', 'Affiliation': 'Sechenov First Moscow State Medical University (Sechenov University).'}]",Terapevticheskii arkhiv,['10.26442/00403660.2019.10.000333'] 2298,32598657,[Impact of endothelial dysfunction on the course of acute ST-elevation myocardial infarction and its correction by remote ischemic preconditioning].,"Aim of the study - to assess the effect of remote ischemic preconditioning (RIPC) on the incidence of endothelial dysfunction (ED) and its impact on hospital prognosis in patients with ST segment elevation acute myocardial infarction (STEMI). MATERIALS AND METHODS We conducted a single - centre, open - label prospective study that included 173 patients with STEMI who underwent primary percutaneous coronary intervention within the first 24 hours of the symptoms onset. Before the PCI, patients were randomized into two groups. In the first group (n=86) during the preparation for PCI, we performed RIPC procedure by inflation of the cuff of the tonometer to 200 mm Hg and its further deflation on patient's shoulder, thus creating short cycles of controlled ischemia/reperfusion in hand (4 cycles of ischemia/reperfusion for 5/5 minutes respectively). In the second, control group (n=87), the standard primary PCI was performed without the previous RIPC. Evaluation of the endothelial function was performed on the 2-7th day after admission using the endothelium - dependent flow - mediated dilatation test (FMD) of the brachial artery. Primary endpoints in this study included the presence of ED, in - hospital mortality, life - threatening arrhythmias (ventricular fibrillation/ventricular tachycardia after first 24 hours upon admission), stent thrombosis, clinical signs of heart failure, and a combined endpoint consisting of all the listed above. RESULTS The median values for FMD-test did not differ significantly between the study groups upon admission. Assessment of the FMD of the brachial artery on the 2-7th day after PCI showed that among the patients who underwent RIPC there was a significantly lower percentage of patients with ED than in the patients with STEMI who did not undergo RIPC before PCI (43.1% vs. 75.8% respectively, p=0.0001). We found a significant reduction in the incidence of heart failure and of combined endpoint in the group of patients without ED compared with patients with ED: 0% vs. 9.3% (n=7; p=0.023) and 3.8% (n=2) vs. 16% (n=12; p=0.032) respectively. When assessing the effect of RIPC on hospital prognosis, we also found a significant decrease in the incidence of heart failure and a trend towards a decrease in the combined endpoint in the group of patients who underwent RIPC compared to the control group: 1.5% (n=1) vs. 9.7% (n=6; p=0.045) and 6.2% (n=4) vs. 16.1% (n=10; p=0.073) respectively. CONCLUSION Performance of RIPC before the primary PCI significantly reduces the incidence of ED in patients with STEMI on the 2-7th day of the disease onset. The presence of ED in patients with STEMI is associated with a significant increase in the incidence of heart failure and of the combined endpoint during in - hospital period. RIPC significantly reduces the incidence of heart failure in patients with STEMI during in - hospital period.",2020,We found a significant reduction in the incidence of heart failure and of combined endpoint in the group of patients without ED compared with patients with ED: 0% vs. 9.3% (n=7; p=0.023) and 3.8% (n=2) vs. 16% (n=12; p=0.032) respectively.,"['patients with ST segment elevation acute myocardial infarction (STEMI', '173 patients with STEMI who underwent primary percutaneous coronary intervention within the first 24 hours of the symptoms onset']","['RIPC', 'remote ischemic preconditioning (RIPC']","['endothelial function', 'median values for FMD-test', 'incidence of ED', 'presence of ED, in - hospital mortality, life - threatening arrhythmias (ventricular fibrillation/ventricular tachycardia after first 24 hours upon admission), stent thrombosis, clinical signs of heart failure, and a combined endpoint consisting of all the listed above', 'endothelial dysfunction (ED', 'incidence of heart failure', 'FMD of the brachial artery']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0520886', 'cui_str': 'ST segment elevation'}, {'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction'}, {'cui': 'C1536220', 'cui_str': 'ST Segment Elevation Myocardial Infarction'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}]","[{'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0376466', 'cui_str': 'Ischemic Pre-Conditioning'}]","[{'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0016052', 'cui_str': 'Fibromuscular dysplasia'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0085556', 'cui_str': 'Hospital Mortalities'}, {'cui': 'C3537125', 'cui_str': 'Common terminology criteria for adverse events grade 4'}, {'cui': 'C0003811', 'cui_str': 'Cardiac arrhythmia'}, {'cui': 'C0042510', 'cui_str': 'Ventricular fibrillation'}, {'cui': 'C0042514', 'cui_str': 'Ventricular tachycardia'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C3897493', 'cui_str': 'Stent thrombosis'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0856169', 'cui_str': 'Endothelial dysfunction'}, {'cui': 'C0006087', 'cui_str': 'Structure of brachial artery'}]",173.0,0.04097,We found a significant reduction in the incidence of heart failure and of combined endpoint in the group of patients without ED compared with patients with ED: 0% vs. 9.3% (n=7; p=0.023) and 3.8% (n=2) vs. 16% (n=12; p=0.032) respectively.,"[{'ForeName': 'V N', 'Initials': 'VN', 'LastName': 'Manchurov', 'Affiliation': 'A.I. Evdokimov Moscow State University of Medicine and Dentistry.'}, {'ForeName': 'A M', 'Initials': 'AM', 'LastName': 'Lebedeva', 'Affiliation': 'A.I. Evdokimov Moscow State University of Medicine and Dentistry.'}, {'ForeName': 'N B', 'Initials': 'NB', 'LastName': 'Ryazankina', 'Affiliation': 'A.I. Evdokimov Moscow State University of Medicine and Dentistry.'}, {'ForeName': 'E Y', 'Initials': 'EY', 'LastName': 'Vasilieva', 'Affiliation': 'A.I. Evdokimov Moscow State University of Medicine and Dentistry.'}, {'ForeName': 'A V', 'Initials': 'AV', 'LastName': 'Shpektor', 'Affiliation': 'A.I. Evdokimov Moscow State University of Medicine and Dentistry.'}]",Terapevticheskii arkhiv,['10.26442/00403660.2020.01.000140'] 2299,32598663,[Assessment of the clinical efficacy of telemonitoring and distant counseling in patients with uncontrolled hypertension].,"The aim of the study was to investigate the mathematical correlation of the clinical efficacy of blood pressure telemonitoring and distant counseling (BPTM) in patients in uncontrolled hypertension (HTN). Telehealth tools are widely used in HTN management. However clinical efficacy of such interventions assessed mainly in groups investigated without its populational and attributable impact. Materials and methods. The total of 240 patients were included, then randomized in 2:1 manner to BPTM group (n=160, median age 47 y.o.) and control group (n=80, median age 49 y.o). The user - friendly and secure telehealth software was provided with mobile application (patients) and desktop (doctors) platforms which allowed storage and analysis of self-BP monitoring data and remote consultations. A three - month surveillance was designed with mandatory baseline and final face - to - face visits with the assessment of office systolic BP (oSBP). Mathematical evaluation was based on target SBP rates achieved in comparator groups and included the absolute efficacies (AE), the attributable efficacy (AtE), the relative efficacy (RE) and the population attributable efficacy (PAtE). Results. BPTM group characterized by larger decrease in SBP level compared with controls (-16.8±2.9 mm Hg versus -7.9±3.9 mm Hg; p.",2020,BPTM group characterized by larger decrease in SBP level compared with controls (-16.8±2.9 mm Hg versus -7.9±3.9 mm Hg;,"['240 patients were included, then randomized in 2:1 manner to BPTM group (n=160, median age 47 y.o.) and control group (n=80, median age 49 y.o', 'patients in uncontrolled hypertension (HTN', 'patients with uncontrolled hypertension']","['telemonitoring and distant counseling', 'blood pressure telemonitoring and distant counseling (BPTM']","['SBP level', 'relative efficacy (RE', 'SBP rates']","[{'cui': 'C4319600', 'cui_str': '240'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1868885', 'cui_str': 'Uncontrolled hypertension'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}]","[{'cui': 'C0443203', 'cui_str': 'Distant'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}]","[{'cui': 'C0085805', 'cui_str': 'Androgen Binding Protein'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",240.0,0.0331739,BPTM group characterized by larger decrease in SBP level compared with controls (-16.8±2.9 mm Hg versus -7.9±3.9 mm Hg;,"[{'ForeName': 'M V', 'Initials': 'MV', 'LastName': 'Ionov', 'Affiliation': 'Federal State Budgetary Institution ""V.A. Almazov National Medical Research Center"".'}, {'ForeName': 'O V', 'Initials': 'OV', 'LastName': 'Zhukova', 'Affiliation': 'Federal State Budgetary Educational Institution of Higher Education ""Privolzhsky Research Medical University"".'}, {'ForeName': 'N E', 'Initials': 'NE', 'LastName': 'Zvartau', 'Affiliation': 'Federal State Budgetary Institution ""V.A. Almazov National Medical Research Center"".'}, {'ForeName': 'D I', 'Initials': 'DI', 'LastName': 'Kurapeev', 'Affiliation': 'Federal State Budgetary Institution ""V.A. Almazov National Medical Research Center"".'}, {'ForeName': 'Y S', 'Initials': 'YS', 'LastName': 'Yudina', 'Affiliation': 'Federal State Budgetary Institution ""V.A. Almazov National Medical Research Center"".'}, {'ForeName': 'A O', 'Initials': 'AO', 'LastName': 'Konradi', 'Affiliation': 'Federal State Budgetary Institution ""V.A. Almazov National Medical Research Center"".'}]",Terapevticheskii arkhiv,['10.26442/00403660.2020.01.000481'] 2300,32598683,[The effectiveness of complex therapy using the injectable form of chondroitin sulfate and sodium hyaluronate with osteoarthritis of the knee joint].,"AIM The study on the effectiveness of complex therapy for osteoarthritis (OA) of the knee joint was conducted in real clinical practice. MATERIALS AND METHODS The survey involved 125 patients aged fr om 50 to 70 years (25 men and 100 women) with a diagnosis of knee joint OA (the III roentgenologic Kellgren-Lawrence stage).The average age of the patients was 62±3.21, the average duration of the disease - 9.4±2.8 years. Patients were randomly assigned to three groups of 35 people, the control group had 20 patients. Group 1 patients received non - steroidal anti - inflammatory drugs (NSAIDs) + Injectran(Chondroitin sulfate) 200 mg intramuscularly (I.M.) every other day No. 25.In group 2, patients received NSAIDs + Fermatron 1% 2 ml with an interval of 7 days intra - articularly (I.A.) No. 3. In group 3 - NSAIDs + Injectran 200 mg (I.M.) every other day No. 25 + Fermatron 1% 2 ml with an interval of 7 days (I.A.) No. 3. In the control group (20 people), patients received only NSAIDs. Evaluation of the symptoms was carried out using the WOMAC index before the start of thetherapy, after 8 and 12 weeks of treatment. The intensity of pain while walking was estimated on a visual analogue scale. RESULTS In the groups that received Injectran (I; group 1) or Fermatron (F; group 2), the dynamics of pain while walking reduction was comparable and had slightly more than 30% in both groups, the figures are reliable in comparison withinitial data (p.",2019,"In the groups that received Injectran (I; group 1) or Fermatron (F; group 2), the dynamics of pain while walking reduction was comparable and had slightly more than 30% in both groups, the figures are reliable in comparison withinitial data (","['125 patients aged fr om 50 to 70 years (25 men and 100 women) with a diagnosis of knee joint OA (the III roentgenologic Kellgren-Lawrence stage).The average age of the patients was 62±3.21, the average duration of the disease - 9.4±2.8 years', 'osteoarthritis (OA) of the knee joint was conducted in real clinical practice']","['chondroitin sulfate and sodium hyaluronate', 'non - steroidal anti - inflammatory drugs (NSAIDs) + Injectran(Chondroitin sulfate) 200 mg intramuscularly (I.M', 'complex therapy', 'NSAIDs + Fermatron']","['WOMAC index', 'intensity of pain while walking']","[{'cui': 'C4319551', 'cui_str': '125'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0022745', 'cui_str': 'Knee joint structure'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0205483', 'cui_str': 'Radiologic'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0022417', 'cui_str': 'Joint structure'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}]","[{'cui': 'C0008466', 'cui_str': 'Chondroitin Sulfates'}, {'cui': 'C0087000', 'cui_str': 'Hyaluronate sodium'}, {'cui': 'C0003211', 'cui_str': 'Non-steroidal anti-inflammatory agent'}, {'cui': 'C0038720', 'cui_str': 'Inorganic sulfate'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C3472647', 'cui_str': 'Western Ontario and McMaster Universities osteoarthritis index'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0080331', 'cui_str': 'Walking'}]",125.0,0.018665,"In the groups that received Injectran (I; group 1) or Fermatron (F; group 2), the dynamics of pain while walking reduction was comparable and had slightly more than 30% in both groups, the figures are reliable in comparison withinitial data (","[{'ForeName': 'E A', 'Initials': 'EA', 'LastName': 'Belyaeva', 'Affiliation': 'Tula State University, Medical Institute.'}, {'ForeName': 'O S', 'Initials': 'OS', 'LastName': 'Avdeeva', 'Affiliation': 'Tula State University, Medical Institute.'}]",Terapevticheskii arkhiv,['10.26442/00403660.2019.05.000213'] 2301,32598752,"[Efficacy of H. pylori eradication depending on genetic polymorphism of CYP2C19, MDR1 and IL-1β].","AIM To evaluate an association of genetic polymorphisms CYP2C19, MDR1, and IL-1β on the eradication rate by 10-day modified therapy in patients with H. pylori - associated diseases. MATERIALS AND METHODS In this study was conducted a prospective, randomized trial, included 89 patients with H. pylori - associated diseases. They were divided into 2 groups depending on therapy: clarithromycin 500 mg, b.i.d., amoxicillin 1000 mg, b.i.d., bismuth subcitrate 240 mg, b.i.d. rabeprazole 20 mg or 40 mg, b.i.d. for 10 days. All subjects underwent pharmacogenetic testing of CYP2C19, MDR1, and IL-1β. RESULTS AND DISCUSSION Per - protocol (PP) eradication rates in group with rabeprazole 40 mg were 97.6% (41/42; 95% CI 87.7-99.6), in group with rabeprazole 20 mg were 82.1% (32/39; 95% CI 67.3-91.0). Intention - to - treat analysis in group with rabeprazole 40 mg eradication rates were 89.1% (41/46; 95% CI 77.0-95.3), in group with standard dose rabeprazole - 74.4% (32/43; 95% CI 59.8-85.1). No significant differences in eradication rates between the groups of ultrarapid, rapid, normal and intermediate CYP2C19 metabolizers (PP: 93.5%/90.3%/84.6% respectively; χ2=0.87, p=0.65). Eradication rates in group with IL-1β CC genotype there was no difference among the IL-1β CT and TT genotype groups (PP: 92.9%/85.7%/94.7% respectively; χ2=1.34; p=0.51). The cure rate among MDR1 TT genotype was significantly lower than among subjects in the MDR1 CC/CT genotype groups (PP: 76.2% vs 96.3%: χ2=5.04; p=0.025; OR=8.13). CONCLUSION Ten - day modified triple therapy with high dose rabeprazole significantly high eradication rates in patients with H. pylori - associated diseases. Independent factor for treatment failure is MDR1 CC/CT genotype status.",2019,"No significant differences in eradication rates between the groups of ultrarapid, rapid, normal and intermediate CYP2C19 metabolizers (PP: 93.5%/90.3%/84.6% respectively; χ2=0.87, p=0.65).","['patients with H. pylori - associated diseases', '89 patients with H. pylori - associated diseases']","['amoxicillin', 'therapy: clarithromycin', 'bismuth subcitrate', 'rabeprazole']","['eradication rate', 'eradication rates', 'cure rate among MDR1 TT genotype', 'Eradication rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0079488', 'cui_str': 'Helicobacter pylori'}, {'cui': 'C0243083', 'cui_str': 'associated disease'}]","[{'cui': 'C0002645', 'cui_str': 'Amoxicillin'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0055856', 'cui_str': 'Clarithromycin'}, {'cui': 'C0106556', 'cui_str': 'bismuth subcitrate'}, {'cui': 'C0378482', 'cui_str': 'rabeprazole'}]","[{'cui': 'C0017431', 'cui_str': 'Genotype'}]",89.0,0.0359192,"No significant differences in eradication rates between the groups of ultrarapid, rapid, normal and intermediate CYP2C19 metabolizers (PP: 93.5%/90.3%/84.6% respectively; χ2=0.87, p=0.65).","[{'ForeName': 'N V', 'Initials': 'NV', 'LastName': 'Bakulina', 'Affiliation': 'Mechnikov North-Western State Medical University.'}, {'ForeName': 'I V', 'Initials': 'IV', 'LastName': 'Maev', 'Affiliation': 'Yevdokimov Moscow State University of Medicine and Dentistry.'}, {'ForeName': 'I V', 'Initials': 'IV', 'LastName': 'Savilova', 'Affiliation': 'Mechnikov North-Western State Medical University.'}, {'ForeName': 'I G', 'Initials': 'IG', 'LastName': 'Bakulin', 'Affiliation': 'Mechnikov North-Western State Medical University.'}, {'ForeName': 'T A', 'Initials': 'TA', 'LastName': ""Il'chishina"", 'Affiliation': 'SM-clinic.'}, {'ForeName': 'K A', 'Initials': 'KA', 'LastName': 'Zagorodnikova', 'Affiliation': 'Mechnikov North-Western State Medical University.'}, {'ForeName': 'A A', 'Initials': 'AA', 'LastName': 'Murzina', 'Affiliation': 'Mechnikov North-Western State Medical University.'}, {'ForeName': 'D N', 'Initials': 'DN', 'LastName': 'Andreev', 'Affiliation': 'Yevdokimov Moscow State University of Medicine and Dentistry.'}]",Terapevticheskii arkhiv,['10.26442/00403660.2019.08.000380'] 2302,32598793,[Evaluation of the effectiveness of ARVI treatment regimen including etiotropic (enisamium iodide) and symptomatic treatment].,"AIM To assess the effectiveness of the use of the antiviral drug enisamium iodide in the complex treatment of acute respiratory viral infections (ARVI) caused by various pathogens in routine clinical practice. MATERIALS AND METHODS А prospective randomized study included 134 patients who were treated in the epidemic season of influenza and ARVI in 20182019. All patients were examined for the presence of influenza A and B viruses, respiratory syncytial virus, human metapneumovirus, parainfluenza virus, coronaviruses, rhinoviruses, adenoviruses in nasopharyngeal swabs by PCR. Patients of the main group received enisamium iodide along with symptomatic therapy, the control group received only symptomatic therapy. The primary parameter of the effectiveness of therapy was evaluated on the scale of the general severity of the manifestations of ARVI (Total Symptom Score TSS) from the 2nd to the 4th day and by the secondary criteria of effectiveness: assessment of the duration of ARVI, the severity of fever, the proportion of patients with normal body temperature, the duration of the main clinical symptoms of acute respiratory viral infections, the proportion of patients in whom complications requiring antibiotics were noted, the dynamics of interferon status on the 6th day. To conduct a statistical analysis, depending on the efficiency parameter, the ANCOVA method with a fixed group factor and an initial score on the TSS severity scale was used as covariates, a criterion for comparing quantitative indicators in two independent groups. RESULTS According to the results of the analysis of the primary efficacy parameter, the median (interquartile range) of the average score on the scale of the general severity of ARVI manifestations in the main group was 4.33 (3.675.83), in the comparison group 6.00 (4.677.25; p0.001). The duration of systemic and local manifestations of acute respiratory viral infections was statistically significantly less in the main group (p=0.002 and p=0.019, respectively). Prescription of additional therapy was required in 2 (2.9%) patients of the main group (patients taking enisamium iodide), compared with 8 (11.9%) patients in the control group. Serum levels of interferon  and interferon  on the last day of treatment were statistically significantly higher in patients of the main group compared with the control group (p0.001). Treatment (excellent) was evaluated by 42 (62.7%) patients, while in the control group only 17 (25.8%) patients gave similar ratings. Both patients (p0.001) and doctors (p0.002) rated therapy tolerance better in the study group. CONCLUSION The results confirmed the safety and effectiveness of enisamium iodide as a treatment for ARVI and influenza. The antiviral, interferonogenic and anti-inflammatory properties of the drug are involved in the formation of an antiviral response and reduce the risk of complications, which makes it possible to reduce the number of symptomatic agents used.",2020,"Both patients (p0.001) and doctors (p0.002) rated therapy tolerance better in the study group. ","['134 patients who were treated in the epidemic season of influenza and ARVI in 20182019', 'acute respiratory viral infections (ARVI']","['enisamium iodide along with symptomatic therapy, the control group received only symptomatic therapy', 'ARVI']","['safety and effectiveness', 'duration of ARVI, the severity of fever', 'general severity of the manifestations of ARVI (Total Symptom Score TSS', 'therapy tolerance', 'TSS severity scale', 'duration of systemic and local manifestations of acute respiratory viral infections', 'general severity of ARVI manifestations', 'Serum levels of interferon \uf0e1 and interferon \uf0e3']","[{'cui': 'C4517565', 'cui_str': '134'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0014499', 'cui_str': 'Epidemic'}, {'cui': 'C0036497', 'cui_str': 'Seasons'}, {'cui': 'C0021400', 'cui_str': 'Influenza'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0729531', 'cui_str': 'Viral respiratory infection'}]","[{'cui': 'C2983877', 'cui_str': 'enisamium iodide'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0729531', 'cui_str': 'Viral respiratory infection'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0729531', 'cui_str': 'Viral respiratory infection'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0205319', 'cui_str': 'Manifest'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0600327', 'cui_str': 'Toxic shock syndrome'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021747', 'cui_str': 'Interferon'}]",134.0,0.0236385,"Both patients (p0.001) and doctors (p0.002) rated therapy tolerance better in the study group. ","[{'ForeName': 'D A', 'Initials': 'DA', 'LastName': 'Lioznov', 'Affiliation': 'Smorodintcev Research Institute of Influenza.'}, {'ForeName': 'E J', 'Initials': 'EJ', 'LastName': 'Karnaukhova', 'Affiliation': 'Pavlov First Saint Petersburg State Medical University.'}, {'ForeName': 'T G', 'Initials': 'TG', 'LastName': 'Zubkova', 'Affiliation': 'Smorodintcev Research Institute of Influenza.'}, {'ForeName': 'E V', 'Initials': 'EV', 'LastName': 'Shakhlanskaya', 'Affiliation': 'Smorodintcev Research Institute of Influenza.'}]",Terapevticheskii arkhiv,['10.26442/00403660.2020.03.000572'] 2303,32598808,[Preprocedural high - sensitivity C-reactive protein (hsCRP) decrease during intensive atorvastatin therapy: the presumable impact on atherosclerosis progression after coronary stenting].,"Proinflammatory status is the risk factor for coronary atherosclerosis progression after coronary stenting (CS). Intensive statin treatment is associated with hsCRP concentration decline. AIM to evaluate prognostic significance of preprocedural hsCRP level reduction with intensive statin regimen for coronary atherosclerosis progression during one year after CS. MATERIALS AND METHODS We enrolled 102 patients with stable angina who were on list for scheduled CS. Group I (n=37) patients received atorvastatin 80 mg for 7 days before and 3 months after CS with further dose adjustment according to LDL; group II (n=65) patients received atorvastatin 20-40 mg/day for LDL goal achievement. HsCRP level was assessed at baseline, before CS and after 1, 3, 6 and 12 months. Coronary atherosclerosis progression was defined as new ≥50% stenosis or ≥30% increase of ≥20% pre - existing stenosis according to coronary angiography (CA) 1 year after CS. RESULTS Baseline concentration of hsCRP was comparable: 0.21 (0.13; 0.38) vs. 0.20 (0.1; 0.44) mg/dl in groups I and II, respectively (p>0.05). In group I significant hsCRP level decrease to 0.14 (0.07; 0.32) mg/dl (p.",2019,In group I significant hsCRP level decrease to 0.14 (0.07; 0.32),"['We enrolled 102 patients with stable angina who were on list for scheduled CS', 'coronary atherosclerosis progression after coronary stenting (CS', 'coronary atherosclerosis progression during one year after CS']","['atorvastatin', 'atorvastatin therapy', 'atorvastatin 20-40 mg/day for LDL goal achievement', 'intensive statin regimen']","['Coronary atherosclerosis progression', 'HsCRP level', 'atherosclerosis progression', 'hsCRP level']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0340288', 'cui_str': 'Stable angina'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C4082117', 'cui_str': 'One year'}]","[{'cui': 'C0286651', 'cui_str': 'atorvastatin'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}]","[{'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0004153', 'cui_str': 'Atherosclerosis'}]",102.0,0.0230838,In group I significant hsCRP level decrease to 0.14 (0.07; 0.32),"[{'ForeName': 'A M', 'Initials': 'AM', 'LastName': 'Shchinova', 'Affiliation': 'National Medical Research Center of Cardiology.'}, {'ForeName': 'G V', 'Initials': 'GV', 'LastName': 'Shlevkova', 'Affiliation': 'National Medical Research Center of Cardiology.'}, {'ForeName': 'A Y', 'Initials': 'AY', 'LastName': 'Filatova', 'Affiliation': 'National Medical Research Center of Cardiology.'}, {'ForeName': 'A V', 'Initials': 'AV', 'LastName': 'Potekhina', 'Affiliation': 'National Medical Research Center of Cardiology.'}, {'ForeName': 'A K', 'Initials': 'AK', 'LastName': 'Osokina', 'Affiliation': 'National Medical Research Center of Cardiology.'}, {'ForeName': 'I V', 'Initials': 'IV', 'LastName': 'Romasov', 'Affiliation': 'National Medical Research Center of Cardiology.'}, {'ForeName': 'E A', 'Initials': 'EA', 'LastName': 'Zharova', 'Affiliation': 'National Medical Research Center of Cardiology.'}, {'ForeName': 'E A', 'Initials': 'EA', 'LastName': 'Noeva', 'Affiliation': 'National Medical Research Center of Cardiology.'}, {'ForeName': 'A N', 'Initials': 'AN', 'LastName': 'Samko', 'Affiliation': 'National Medical Research Center of Cardiology.'}, {'ForeName': 'V P', 'Initials': 'VP', 'LastName': 'Masenko', 'Affiliation': 'National Medical Research Center of Cardiology.'}, {'ForeName': 'T I', 'Initials': 'TI', 'LastName': 'Arefieva', 'Affiliation': 'National Medical Research Center of Cardiology.'}, {'ForeName': 'S I', 'Initials': 'SI', 'LastName': 'Provatorov', 'Affiliation': 'National Medical Research Center of Cardiology.'}]",Terapevticheskii arkhiv,['10.26442/00403660.2019.09.000144'] 2304,32598809,[Exercise training and erectile dysfunction in patients after coronary artery bypass grafting].,"AIM to estimate the effects of exercise training on erectile function after coronary artery bypass grafting. MATERIALS AND METHODS 114 men with stable coronary artery disease undergoing on - pump coronary artery bypass grafting were examined. Patients with ED were randomized into two groups comparable in the main demographic, clinical and baseline parameters: a group of patients undergoing supervised exercise trainings at the outpatient rehabilitation center (n=53) and a group of patients without any exercise trainings at the outpatient hospital (n=61). Patients were assessed 1, 6 and 12 months after CABG. All patients underwent echocardiography (ECHO-CG), bicycle ergometer test without discontinuation of the drug therapy, measurement of nocturnal penile tumescence (NPT), ultrasound assessment of the cavernous arteries with the further estimation of their endothelial function. RESULTS In addition to the expected improvements in exercise tolerance, regular cycling exercises led to a significant recovery of erectile function (number and duration of NTP, increased penile blood flow volume, estimated during NTP measurement), improved endothelial function of the cavernous arteries, compared to patients without exercise trainings. However, the obtained effects in the group with exercise trainings were short - term. One year after CABG, the number of NTP and penile blood flow volume were superior in patients undergoing exercise trainings. Differences in other parameters became less reliable between the groups. CONCLUSION Aerobic exercise trainings appeared to be effective for optimizing exercise tolerance, erectile and endothelial function, and allow improving the prognosis of these patients and, therefore, are needed to be included in the rehabilitation programs for patients undergoing CABG.",2019,"One year after CABG, the number of NTP and penile blood flow volume were superior in patients undergoing exercise trainings.","['Patients with ED', '114 men with stable coronary artery disease undergoing on - pump coronary artery bypass grafting were examined', 'patients undergoing CABG', 'patients after coronary artery bypass grafting']","['exercise training', 'Aerobic exercise trainings', 'echocardiography (ECHO-CG), bicycle ergometer test without discontinuation of the drug therapy, measurement of nocturnal penile tumescence (NPT), ultrasound assessment of the cavernous arteries with the further estimation of their endothelial function', 'Exercise training', 'supervised exercise trainings at the outpatient rehabilitation center (n=53) and a group of patients without any exercise trainings']","['exercise tolerance, erectile and endothelial function', 'erectile function (number and duration of NTP, increased penile blood flow volume', 'erectile function', 'number of NTP and penile blood flow volume', 'endothelial function of the cavernous arteries']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4708785', 'cui_str': '114'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0332128', 'cui_str': 'Examined for'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0013516', 'cui_str': 'Echocardiography'}, {'cui': 'C0013520', 'cui_str': 'Doppler Echocardiography'}, {'cui': 'C0180749', 'cui_str': 'Bicycle ergometer'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0372464', 'cui_str': 'Nocturnal penile tumescence'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205201', 'cui_str': 'Cavernous'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0034993', 'cui_str': 'Centers, Rehabilitation'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0162521', 'cui_str': 'Exercise tolerance'}, {'cui': 'C0030847', 'cui_str': 'Penile erection'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0030851', 'cui_str': 'Penile structure'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0205201', 'cui_str': 'Cavernous'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}]",114.0,0.0235409,"One year after CABG, the number of NTP and penile blood flow volume were superior in patients undergoing exercise trainings.","[{'ForeName': 'S A', 'Initials': 'SA', 'LastName': 'Pomeshkina', 'Affiliation': 'Research Institute for Complex Issues of Cardiovascular Diseases.'}, {'ForeName': 'O L', 'Initials': 'OL', 'LastName': 'Barbarash', 'Affiliation': 'Research Institute for Complex Issues of Cardiovascular Diseases.'}, {'ForeName': 'E V', 'Initials': 'EV', 'LastName': 'Pomeshkin', 'Affiliation': 'Kemerovo State Medical University.'}]",Terapevticheskii arkhiv,['10.26442/00403660.2019.09.000149'] 2305,32598811,[Possibilities of cardioselective beta - blocker bisoprolol therapy in patients having coronary artery disease and bronchial asthma].,"AIM to compare the antianginal and pulse slowing effects, the impact on the ectopic myocardial activity as well as the safety of the treatment with beta - adrenoblocker bisoprolol, calcium antagonist verapamil and the combination of bisoprolol with amlodipine in patients with stable angina (SA) and bronchial asthma (BA). MATERIALS AND METHODS The study included 90 patients with SA II-III functional class (FC) having concomitant persistent asthma of moderate severity, controlled, without exacerbation. The patients were divided into three groups with 30 individuals in each one depending on the main antianginal drug prescribed. Group 1 patients received a cardio - selective beta - adrenergic blocker bisoprolol (Concor) at the dose of 5 mg/day, patients of group 2 were treated by a calcium antagonist verapamil at the dose of 240 mg/day, patients of group 3 received combined therapy with bisoprolol at the dose of 5 mg/day and amlodipine at the dose of 5 mg/day given as a fixed combination (Concor AM 5/5). All the patients were investigated by the methods of daily ECG monitoring and respiratory function study (RFS) in addition to physical examination at baseline and after 4 weeks of treatment. RESULTS After 4 weeks of treatment, patients of group 1 and group 3 did not complain of angina attacks and did not use nitroglycerin unlike patients of group 2. The achieved heart rate (HR) in group 1 patients was 68.6±8.5 beats/min, in group 2 - 74.3±5.6 beats/min, in group 3 - 67.3±4.8 beats/min. A significant decrease in the number of supraventricular and ventricular extrasystoles occurred in patients of group 1 and group 3 only. Thus, the pulse slowing, antianginal, antiischemic and antiarrhythmic effect of the calcium antagonist verapamil, even at the dose of 240 mg/day, is not always sufficient for the patients with SA II-III FC and concomitant BA, unlike therapy with the inclusion of beta - blocker bisoprolol. During the study there was no registered deterioration in the indices of bronchial patency according to the RFS data in the patients of all three groups. CONCLUSION In patients with coronary artery disease and concomitant asthma, all three types of pulse slowing therapy do not have any negative effects on bronchial patency. Therapy with the inclusion of beta - blockers (bisoprolol or its combination with amlodipine), in contrast to verapamil, reliably reduces heart rate and the number of supraventricular and ventricular extrasystoles in addition to a good antianginal effect.",2019,A significant decrease in the number of supraventricular and ventricular extrasystoles occurred in patients of group 1 and group 3 only.,"['patients with coronary artery disease and concomitant asthma', 'patients having coronary artery disease and bronchial asthma', 'patients with stable angina (SA) and bronchial asthma (BA', '90 patients with SA II-III functional class (FC) having concomitant persistent asthma of moderate severity, controlled, without exacerbation']","['calcium antagonist verapamil', 'verapamil', 'beta - adrenoblocker bisoprolol, calcium antagonist verapamil', 'cardioselective beta - blocker bisoprolol therapy', 'beta - blockers (bisoprolol or its combination with amlodipine', 'bisoprolol with amlodipine', 'combined therapy with bisoprolol at the dose of 5 mg/day and amlodipine', 'nitroglycerin', 'cardio - selective beta - adrenergic blocker bisoprolol (Concor']","['complain of angina attacks', 'heart rate and the number of supraventricular and ventricular extrasystoles', 'heart rate (HR', 'bronchial patency', 'number of supraventricular and ventricular extrasystoles', 'pulse slowing, antianginal, antiischemic and antiarrhythmic effect']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0340288', 'cui_str': 'Stable angina'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C3266628', 'cui_str': 'Persistent asthma'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0006684', 'cui_str': 'Calcium channel blocker'}, {'cui': 'C0042523', 'cui_str': 'Verapamil'}, {'cui': 'C0330390', 'cui_str': 'Beta'}, {'cui': 'C0053799', 'cui_str': 'Bisoprolol'}, {'cui': 'C0304516', 'cui_str': 'Beta-1 adrenergic receptor antagonist'}, {'cui': 'C3698199', 'cui_str': 'Bisoprolol therapy'}, {'cui': 'C0001645', 'cui_str': 'Beta adrenergic receptor antagonist'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0051696', 'cui_str': 'Amlodipine'}, {'cui': 'C0033972', 'cui_str': 'Combined therapy'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0017887', 'cui_str': 'Nitroglycerin'}, {'cui': 'C0110591', 'cui_str': 'Concor'}]","[{'cui': 'C0235462', 'cui_str': 'Anginal attack'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0151636', 'cui_str': 'Ventricular premature beats'}, {'cui': 'C0205039', 'cui_str': 'Bronchial'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0428977', 'cui_str': 'Bradycardia'}, {'cui': 'C0003195', 'cui_str': 'Antiarrhythmic agent'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",90.0,0.0164006,A significant decrease in the number of supraventricular and ventricular extrasystoles occurred in patients of group 1 and group 3 only.,"[{'ForeName': 'N Y', 'Initials': 'NY', 'LastName': 'Grigorieva', 'Affiliation': 'Privolzhsky Research Medical University.'}, {'ForeName': 'T P', 'Initials': 'TP', 'LastName': 'Ilyushina', 'Affiliation': 'Privolzhsky Research Medical University.'}, {'ForeName': 'E M', 'Initials': 'EM', 'LastName': 'Yashina', 'Affiliation': 'Privolzhsky Research Medical University.'}]",Terapevticheskii arkhiv,['10.26442/00403660.2019.09.000268'] 2306,32598812,[Comparative efficacy and safety of enoxaparin followed by warfarin and rivaroxaban monotherapy in the treatment of venous thrombosis in patients after intracardiac catheter interventions].,"AIM to compare two anticoagulant therapy (ACT) regimens in the treatment of venous thrombosis (VT) in patients after catheter interventions - electrophysiological studies (EFIs) and ablations: enoxaparin followed by warfarin, and rivaroxaban monotherapy. MATERIALS AND METHODS The study included patients from 18 years and older with heart rhythm disorders and planned catheter ablation. When parietal venous thrombosis (VT) were detected at the femoral vein puncture site, all patients were randomly assigned to two treatment groups. In group I enoxaparin 1 mg/kg was prescribed every 12 hours with switching to warfarin after 7 days with maintenance of the target INR values (2.0-3.0). In group II rivaroxaban therapy was started at a dose of 15 mg twise/day for 21 days with a further transition to a dose of 20 mg/day. The total period of observation and treatment of patients was at least 3 months. RESULTS 408 patients were observed, 42 (10.3%) patients with parietal VT were divided into two treatment groups. In group I (n=16) complete lysis of VT was noted by the 7th day of treatment in 7 (58.3%) patients, however this scheme was associated with a greater risk of complications (р=0.003) at the puncture site in the form of arteriovenous fistulae (n=1; 8.3%) and intermuscular hematomas (n=4; 25%). In group II (n=26), no complications were noted, the lysis time of VT was on average 21 days (n=18; 69.2%). Complete lysis of VT was noted in both groups at the time of the control observation point (3rd month). CONCLUSION The efficiency of the two VT treatment regimens was comparable. Enoxaparin therapy is associated with a high risk of local complications, namely intermuscular hematomas (n=4; 25%) and arteriovenous fistulas (n=1; 8.3%). Rivaroxaban monotherapy is safer (p=0.003); in Group II none of the patients had any complications.",2019,Rivaroxaban monotherapy is safer (p=0.003); in Group II none of the patients had any complications.,"['patients after intracardiac catheter interventions', 'patients after catheter interventions - electrophysiological studies (EFIs) and ablations', '408 patients were observed, 42 (10.3%) patients with parietal VT', 'patients from 18 years and older with heart rhythm disorders and planned catheter ablation']","['Rivaroxaban monotherapy', 'enoxaparin followed by warfarin, and rivaroxaban monotherapy', 'warfarin and rivaroxaban monotherapy', 'anticoagulant therapy (ACT', 'Enoxaparin', 'rivaroxaban', 'enoxaparin']","['lysis time of VT', 'complete lysis of VT', 'Complete lysis of VT', 'venous thrombosis', 'intermuscular hematomas', 'risk of complications', 'venous thrombosis (VT']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0179724', 'cui_str': 'Cardiac catheter'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C4517769', 'cui_str': '408'}, {'cui': 'C4517519', 'cui_str': '10.3'}, {'cui': 'C0442030', 'cui_str': 'Parietal'}, {'cui': 'C0042487', 'cui_str': 'Venous thrombosis'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0003811', 'cui_str': 'Cardiac arrhythmia'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0162563', 'cui_str': 'Cardiac ablation'}]","[{'cui': 'C1739768', 'cui_str': 'rivaroxaban'}, {'cui': 'C0206460', 'cui_str': 'Enoxaparin'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0043031', 'cui_str': 'Warfarin'}, {'cui': 'C0150457', 'cui_str': 'Anticoagulant therapy'}]","[{'cui': 'C0024348', 'cui_str': 'Lysis'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0042487', 'cui_str': 'Venous thrombosis'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0554597', 'cui_str': 'Intermuscular hematoma'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",408.0,0.0304219,Rivaroxaban monotherapy is safer (p=0.003); in Group II none of the patients had any complications.,"[{'ForeName': 'A I', 'Initials': 'AI', 'LastName': 'Loginova', 'Affiliation': 'National Medical Research Center of Cardiology.'}, {'ForeName': 'E S', 'Initials': 'ES', 'LastName': 'Kropacheva', 'Affiliation': 'National Medical Research Center of Cardiology.'}, {'ForeName': 'E B', 'Initials': 'EB', 'LastName': 'Maykov', 'Affiliation': 'National Medical Research Center of Cardiology.'}, {'ForeName': 'T V', 'Initials': 'TV', 'LastName': 'Balakhonova', 'Affiliation': 'National Medical Research Center of Cardiology.'}, {'ForeName': 'S P', 'Initials': 'SP', 'LastName': 'Golitsyn', 'Affiliation': 'National Medical Research Center of Cardiology.'}]",Terapevticheskii arkhiv,['10.26442/00403660.2019.09.000282'] 2307,32598834,Effect of antioxidant supplementation containing L-carnitine on semen parameters: a prospective interventional study.,"OBJECTIVE One of the remarkable causes of infertility in men is oxidative stress having a reducing effect on their reproductive function. In the present study, we investigated the efficacy of supplementation with antioxidants and L-Carnitine (contained in Androferti) on semen parameters. METHODS We included 180 infertile male patients diagnosed with idiopathic oligoastenoteratozoospermia (OAT) in this study, and we analyzed the semen sample from 59 patients before and after oral antioxidant treatment, with the commercial name of Androferti (containing 1500 mg of L-Carnitine, 60 mg of vitamin C, 20 mg of coenzyme Q10, 10 mg of vitamin E, 10 mg of zinc, 200 µg of vitamin B9, 50 µg of selenium, 1 µg of vitamin B12). All of the patients received Androferti twice a day for 3 months. RESULTS There were significant improvements in the sperm concentration (p=0.004) after the antioxidant supplementation. There was also a meaningfully improvement in sperm morphology (p=0.01) after treatment. However, sperm motility was not significantly altered after antioxidant treatment (p=0.2). CONCLUSIONS Antioxidants supplementation containing 1500 mg L-carnitine can improve the semen quality in infertile men diagnosed with idiopathic OAT. However, further studies are required to determine the antioxidant effects on reproduction function.",2020,There were significant improvements in the sperm concentration (p=0.004) after the antioxidant supplementation.,"['infertile men diagnosed with idiopathic OAT', '180 infertile male patients diagnosed with idiopathic oligoastenoteratozoospermia (OAT) in this study, and we analyzed the semen sample from 59 patients before and after oral antioxidant treatment, with the commercial name of']","['antioxidant supplementation containing L-carnitine', 'Antioxidants supplementation containing 1500 mg L-carnitine', 'Androferti (containing 1500 mg of L-Carnitine, 60 mg of vitamin C, 20 mg of coenzyme Q10, 10 mg of vitamin E, 10 mg of zinc, 200 µg of vitamin B9, 50 µg of selenium, 1 µg of vitamin B12', 'supplementation with antioxidants and L-Carnitine']","['sperm motility', 'semen quality', 'sperm concentration', 'semen parameters', 'sperm morphology']","[{'cui': 'C0021359', 'cui_str': 'Sterility'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0444176', 'cui_str': 'Seminal fluid specimen'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0027365', 'cui_str': 'Name'}]","[{'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0087163', 'cui_str': 'Levocarnitine'}, {'cui': 'C4517582', 'cui_str': '1500'}, {'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C0056077', 'cui_str': 'Ubiquinone'}, {'cui': 'C0042874', 'cui_str': 'Vitamin E'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0016410', 'cui_str': 'Folic Acid'}, {'cui': 'C0036581', 'cui_str': 'Selenium'}, {'cui': 'C0042845', 'cui_str': 'Vitamin B 12'}]","[{'cui': 'C0037848', 'cui_str': 'Motility of spermatozoa'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0429845', 'cui_str': 'Sperm concentration measurement'}, {'cui': 'C0036563', 'cui_str': 'Plant seeds'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0428011', 'cui_str': 'Sperm morphology'}]",180.0,0.320178,There were significant improvements in the sperm concentration (p=0.004) after the antioxidant supplementation.,"[{'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Nazari', 'Affiliation': 'Department of Obstetrics and Gynecology, Preventative Gynecology Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Saghar', 'Initials': 'S', 'LastName': 'Salehpour', 'Affiliation': 'Department of Obstetrics and Gynecology, Preventative Gynecology Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Sedighe', 'Initials': 'S', 'LastName': 'Hosseini', 'Affiliation': 'Department of Obstetrics and Gynecology, Preventative Gynecology Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Farzad', 'Initials': 'F', 'LastName': 'Allameh', 'Affiliation': 'Department of Urology, Preventative Gynecology Research Center, Shahid Beheshti University o f Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Ferdoos', 'Initials': 'F', 'LastName': 'Jahanmardi', 'Affiliation': 'Department of Obstetrics and Gynecology, Preventative Gynecology Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Elham', 'Initials': 'E', 'LastName': 'Azizi', 'Affiliation': 'Department of Biology and Anatomical Sciences, Student Research Committee, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Robabeh', 'Initials': 'R', 'LastName': 'Ghodssi-Ghassemabadi', 'Affiliation': 'Department of Biostatistics, Faculty of Medical Sciences, Tarbiat Modares University, Tehran, Iran.'}, {'ForeName': 'Teibeh', 'Initials': 'T', 'LastName': 'Hashemi', 'Affiliation': 'Department of Obstetrics and Gynecology, Preventative Gynecology Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}]",JBRA assisted reproduction,['10.5935/1518-0557.20200043'] 2308,32598909,Early vaginal progesterone versus Placebo in Twin Pregnancies for prevention of spontaneous preterm birth (EVENTS): A randomised double-blind trial.,"BACKGROUND In women with a singleton pregnancy and sonographic short cervix in mid-gestation, vaginal administration of progesterone reduces the risk of early preterm birth and improves neonatal outcomes, without any demonstrable deleterious effects on childhood neurodevelopment. In women with twin pregnancies the rate of spontaneous early preterm birth is 10-times higher than in singletons and in this respect all twins are at increased risk of preterm birth. However, six trials in unselected twin pregnancies reported that vaginal progesterone from mid-gestation had no significant effect on the incidence of early preterm birth. Such apparent lack of effectiveness of progesterone in twins may be due to inadequate dosage or treatment which is started too late in pregnancy. OBJECTIVE The Early vaginal progesterone for the preVention of spontaneous prEterm birth iN TwinS: A randomized, placebo controlled, double-blinded trial (EVENTS) was designed to test the hypothesis that, among women with twin pregnancies, vaginal progesterone at a dose of 600 mg per day from 11-14 until 34 weeks' gestation, as compared with placebo, would result in a significant reduction in the incidence of spontaneous preterm birth between 24 +0 and 33 +6 weeks. METHODS The trial was conducted at 22 hospitals in England, Spain, Bulgaria, Italy, Belgium and France. Women were randomly assigned in a 1:1 ratio, to receive either progesterone or placebo and in the random-sequence generation there was stratification according to participating center. Primary outcome was spontaneous birth between 24 +0 and 33 +6 weeks' gestation. Statistical analyses were performed on an intention-to-treat basis. Logistic regression analysis was used to determine the significance of difference in incidence of spontaneous birth between 24 +0 and 33 +6 weeks' gestation between the progesterone and placebo groups, adjusting for the effect of participating centre, chrorionicity, parity and method of conception. Prespecified tests of treatment interaction effects with chrorionicity, parity, method of conception, compliance and cervical length at recruitment were performed. A post hoc analysis using mixed effects Cox regression was used for further exploration of the effect of progesterone on preterm birth. RESULTS We recruited 1,194 women between May 2017 and April 2019; 21 withdrew consent and 4 were lost to follow up, which left 582 in the progesterone group and 587 in the placebo group. Adherence was good, with reported intake of ≥80% of the required number of capsules in 81.4% of the participants. After excluding births before 24 weeks and indicated deliveries before 34 weeks, spontaneous birth between 24 +0 and 33 +6 weeks occurred in 10.4% (56/541) participants in the progesterone group and in 8.2% (44/538) in the placebo group (odds ratio in the progesterone group, adjusting for the effect of participating center, chrorionicity, parity and method of conception, 1.35; 95% CI 0.88 - 2.05; p=0.17). There was no evidence of interaction between the effects of treatment and chorionicity (p=0.28), parity (p=0.35) method of conception (p=0.56) and adherence (p=0.34); however, there was weak evidence of an interaction with cervical length (p=0.08) suggestive of harm to those with cervical length ≥30 mm (odds ratio 1.61, 95% CI 1.01-2.59) and potential benefit for those with cervical length <30 mm (odds ratio 0.56; 95% CI 0.20-1.60). There was no evidence of difference between the two treatment groups for stillbirth or neonatal death; neonatal complications; neonatal therapy; and poor fetal growth. In the progesterone group there were 1.4% (8/582) women and 1.9% (22/1,164) fetuses with at least one serious adverse event; the respective numbers for the placebo group were 1.2% (7/587) and 3.2% (37/1,174) (p=0.80 and p=0.06, respectively). In the post hoc time to event analysis, miscarriage or spontaneous preterm birth between randomization and 31 +6 weeks' gestation was reduced in the progesterone group relative to the placebo group (hazard ratio 0.23, 95% CI 0.08 - 0.69). CONCLUSIONS In women with twin pregnancies universal treatment with vaginal progesterone did not reduce the incidence of spontaneous birth between 24 +0 and 33 +6 weeks' gestation. Post hoc time to event analysis led to the suggestion that progesterone may reduce the risk of spontaneous birth <32 weeks in women with cervical length <30 mm and it may increase the risk for those with cervical length ≥30 mm.",2020,There was no evidence of difference between the two treatment groups for stillbirth or neonatal death; neonatal complications; neonatal therapy; and poor fetal growth.,"[""women with twin pregnancies, vaginal progesterone at a dose of 600 mg per day from 11-14 until 34 weeks' gestation"", '1,194 women between May 2017 and April 2019; 21 withdrew consent and 4 were lost to follow up, which left 582 in the progesterone group and 587 in the placebo group', 'spontaneous prEterm birth iN TwinS', 'women with a singleton pregnancy and sonographic short cervix in mid-gestation, vaginal administration of', '22 hospitals in England, Spain, Bulgaria, Italy, Belgium and France', 'Twin Pregnancies for prevention of spontaneous preterm birth (EVENTS']","['Placebo', 'progesterone and placebo', 'vaginal progesterone', 'progesterone', 'progesterone or placebo', 'placebo']","['spontaneous birth', 'chrorionicity, parity, method of conception, compliance and cervical length', 'vaginal progesterone', 'preterm birth', 'rate of spontaneous early preterm birth', 'cervical length', 'stillbirth or neonatal death; neonatal complications; neonatal therapy; and poor fetal growth', 'incidence of spontaneous preterm birth', 'incidence of spontaneous birth', 'risk of preterm birth', 'incidence of early preterm birth', 'risk of spontaneous birth', 'miscarriage or spontaneous preterm birth']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0152150', 'cui_str': 'Twin pregnancy'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0033308', 'cui_str': 'Progesterone'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0439505', 'cui_str': '/day'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0424092', 'cui_str': 'Withdrawn'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C1302313', 'cui_str': 'Lost to follow-up'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}, {'cui': 'C0041427', 'cui_str': 'Twin sibling'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0007874', 'cui_str': 'Cervix uteri structure'}, {'cui': 'C0444598', 'cui_str': 'Mid'}, {'cui': 'C0001561', 'cui_str': 'Medication administration: vaginal'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C0006368', 'cui_str': 'Bulgaria'}, {'cui': 'C0022277', 'cui_str': 'Italy'}, {'cui': 'C0004950', 'cui_str': 'Belgium'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0441471', 'cui_str': 'Event'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0033308', 'cui_str': 'Progesterone'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}]","[{'cui': 'C0205359', 'cui_str': 'Spontaneous'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0030563', 'cui_str': 'Parity'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0009637', 'cui_str': 'Conception'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}, {'cui': 'C0033308', 'cui_str': 'Progesterone'}, {'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0595939', 'cui_str': 'Stillbirth'}, {'cui': 'C0410916', 'cui_str': 'Newborn death'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0015934', 'cui_str': 'Fetal growth restriction'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0000786', 'cui_str': 'Miscarriage'}]",1194.0,0.774239,There was no evidence of difference between the two treatment groups for stillbirth or neonatal death; neonatal complications; neonatal therapy; and poor fetal growth.,"[{'ForeName': 'Anoop', 'Initials': 'A', 'LastName': 'Rehal', 'Affiliation': ""Fetal Medicine Research Institute, King's College Hospital, London, UK.""}, {'ForeName': 'Zsófia', 'Initials': 'Z', 'LastName': 'Benkő', 'Affiliation': ""Fetal Medicine Research Institute, King's College Hospital, London, UK.""}, {'ForeName': 'Catalina', 'Initials': 'C', 'LastName': 'De Paco Matallana', 'Affiliation': 'Hospital Clínico Universitario Virgen de la Arrixaca and Institute for Biomedical Research of Murcia, IMIB-Arrixaca, Murcia, Spain.'}, {'ForeName': 'Argyro', 'Initials': 'A', 'LastName': 'Syngelaki', 'Affiliation': ""Fetal Medicine Research Institute, King's College Hospital, London, UK.""}, {'ForeName': 'Deepa', 'Initials': 'D', 'LastName': 'Janga', 'Affiliation': 'North Middlesex University Hospital, London, UK.'}, {'ForeName': 'Simona', 'Initials': 'S', 'LastName': 'Cicero', 'Affiliation': 'Homerton University Hospital, London, UK.'}, {'ForeName': 'Ranjit', 'Initials': 'R', 'LastName': 'Akolekar', 'Affiliation': 'Medway Maritime Hospital, Gillingham, UK.'}, {'ForeName': 'Mandeep', 'Initials': 'M', 'LastName': 'Singh', 'Affiliation': 'Southend University Hospital, Westcliff-on-Sea, UK.'}, {'ForeName': 'Petya', 'Initials': 'P', 'LastName': 'Chaveeva', 'Affiliation': 'Dr. Shterev Hospital, Sofia, Bulgaria.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Burgos', 'Affiliation': 'Hospital Universitario Cruces, Biocruces Bizkaia Health Research Institute, UPV/EHU, Bizkaia, Spain.'}, {'ForeName': 'Francisca S', 'Initials': 'FS', 'LastName': 'Molina', 'Affiliation': 'Hospital Universitario San Cecilio, Instituto de Investigación Biosanitaria (IBS) Granada, Spain.'}, {'ForeName': 'Makrina', 'Initials': 'M', 'LastName': 'Savvidou', 'Affiliation': 'Chelsea and Westminster Hospital, Imperial College London, UK.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'De La Calle', 'Affiliation': 'Hospital Universitario La Paz, Madrid, Spain.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Persico', 'Affiliation': 'Ospedale Maggiore Policlinico, Milan and Department of Clinical Sciences and Community Health, University of Milan, Italy.'}, {'ForeName': 'Maria Soledad', 'Initials': 'MS', 'LastName': 'Quezada Rojas', 'Affiliation': 'Hospital Universitario ""12 De Octubre\'\', Madrid, Spain.'}, {'ForeName': 'Ashis', 'Initials': 'A', 'LastName': 'Sau', 'Affiliation': 'Lewisham University Hospital, London, UK.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Greco', 'Affiliation': 'Royal London Hospital, London, UK.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': ""O'Gorman"", 'Affiliation': 'Hospital Necker Enfants Malades, Paris, France.'}, {'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Plasencia', 'Affiliation': 'Hospiten Group, Tenerife, Spain.'}, {'ForeName': 'Susana', 'Initials': 'S', 'LastName': 'Pereira', 'Affiliation': 'Kingston Hospital, Kingston upon Thames, UK.'}, {'ForeName': 'Jacques C', 'Initials': 'JC', 'LastName': 'Jani', 'Affiliation': 'University Hospital Brugmann, Université Libre de Bruxelles, Brussels, Belgium.'}, {'ForeName': 'Nuria', 'Initials': 'N', 'LastName': 'Valino', 'Affiliation': 'University Hospital A Coruña, Spain.'}, {'ForeName': 'Maria Del Mar', 'Initials': 'MDM', 'LastName': 'Gil', 'Affiliation': 'Hospital Universitario de Torrejón and School of Health Sciences. Universidad Francisco de Vitoria, Madrid, Spain.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Maclagan', 'Affiliation': 'Fetal Medicine Foundation, London, UK.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Wright', 'Affiliation': 'University of Exeter, Exeter, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Wright', 'Affiliation': 'University of Exeter, Exeter, UK.'}, {'ForeName': 'Kypros H', 'Initials': 'KH', 'LastName': 'Nicolaides', 'Affiliation': ""Fetal Medicine Research Institute, King's College Hospital, London, UK. Electronic address: kypros@fetalmedicine.com.""}]",American journal of obstetrics and gynecology,['10.1016/j.ajog.2020.06.050'] 2309,32598941,Unskilled shooters improve both accuracy and grouping shot having as reference skilled shooters cortical area: An EEG and tDCS study.,"Transcranial direct current stimulation (tDCS) has been used as a non-invasive method for enhanced motor and cognitive abilities. However, no previous study has investigated if the tDCS application in unskilled shooters on cortical sites, selected based on the cortical activity of skilled shooters, improves the accuracy and shot grouping. Sixty participants were selected, which included 10 skilled shooters and 50 unskilled shooters. After we identified the right dorsolateral prefrontal cortex (DLPFC) as the area with the highest activity in skilled shooters, we applied anodal tDCS over the right DLPFC in the unskilled shooters under two conditions: sham-tDCS (placebo) and real-tDCS (anodal tDCS). We also analyzed electroencephalography. Our results indicated that anodal tDCS application enhanced the shot accuracy (p = 0.001). Furthermore, the beta power in the EEG recording was higher in the left DLPFC, left and right parietal cortex (p = 0,001) after applying anodal tDCS, while the low-gamma power was higher in the right DLPFC in sham-tDCS (p = 0.001) and right parietal cortex after anodal-tDCS (p = 0.001). Our findings indicate that anodal tDCS can improve accuracy and shot grouping when applied over the unskilled shooters' right DLPFC. Furthermore, beta and low-gamma bands are influenced by anodal tDCS over the right DLPFC, which may be predictive of skill improvement.",2020,Our findings indicate that anodal tDCS can improve accuracy and shot grouping when applied over the unskilled shooters' right DLPFC.,"['Sixty participants were selected, which included 10 skilled shooters and 50 unskilled shooters']","['tDCS (placebo) and real-tDCS (anodal tDCS', 'Transcranial direct current stimulation (tDCS', 'anodal tDCS']",['beta power in the EEG recording'],"[{'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}]","[{'cui': 'C0330390', 'cui_str': 'Beta'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}]",60.0,0.0141525,Our findings indicate that anodal tDCS can improve accuracy and shot grouping when applied over the unskilled shooters' right DLPFC.,"[{'ForeName': 'Kaline', 'Initials': 'K', 'LastName': 'Rocha', 'Affiliation': 'Neuro-innovation Technology & Brain Mapping Laboratory, Federal University of Delta of Parnaíba, Parnaíba, Brazil; The Northeast Biotechnology Network, Federal University of Piauí, Teresina, Brazil. Electronic address: kalinemrocha@gmail.com.'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Marinho', 'Affiliation': 'Neuro-innovation Technology & Brain Mapping Laboratory, Federal University of Delta of Parnaíba, Parnaíba, Brazil; The Northeast Biotechnology Network, Federal University of Piauí, Teresina, Brazil.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Magalhães', 'Affiliation': 'Neuro-innovation Technology & Brain Mapping Laboratory, Federal University of Delta of Parnaíba, Parnaíba, Brazil; The Northeast Biotechnology Network, Federal University of Piauí, Teresina, Brazil.'}, {'ForeName': 'Valécia', 'Initials': 'V', 'LastName': 'Carvalho', 'Affiliation': 'Neuro-innovation Technology & Brain Mapping Laboratory, Federal University of Delta of Parnaíba, Parnaíba, Brazil; The Northeast Biotechnology Network, Federal University of Piauí, Teresina, Brazil.'}, {'ForeName': 'Thayaná', 'Initials': 'T', 'LastName': 'Fernandes', 'Affiliation': 'Neuro-innovation Technology & Brain Mapping Laboratory, Federal University of Delta of Parnaíba, Parnaíba, Brazil.'}, {'ForeName': 'Marcos', 'Initials': 'M', 'LastName': 'Ayres', 'Affiliation': 'Neuro-innovation Technology & Brain Mapping Laboratory, Federal University of Delta of Parnaíba, Parnaíba, Brazil; The Northeast Biotechnology Network, Federal University of Piauí, Teresina, Brazil.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Crespo', 'Affiliation': 'Neuro-innovation Technology & Brain Mapping Laboratory, Federal University of Delta of Parnaíba, Parnaíba, Brazil.'}, {'ForeName': 'Bruna', 'Initials': 'B', 'LastName': 'Velasques', 'Affiliation': 'Brain Mapping and Sensory Motor Integration Laboratory, Institute of Psychiatry of Federal University of Rio de Janeiro, Rio de Janeiro, Brazil.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Ribeiro', 'Affiliation': 'Brain Mapping and Sensory Motor Integration Laboratory, Institute of Psychiatry of Federal University of Rio de Janeiro, Rio de Janeiro, Brazil.'}, {'ForeName': 'Mauricio', 'Initials': 'M', 'LastName': 'Cagy', 'Affiliation': 'Biomedical Engineering Program, Federal University of Rio de Janeiro, Rio de Janeiro, Brazil.'}, {'ForeName': 'Victor Hugo', 'Initials': 'VH', 'LastName': 'Bastos', 'Affiliation': 'The Northeast Biotechnology Network, Federal University of Piauí, Teresina, Brazil; Brain Mapping and Functionality Laboratory, Federal University of Delta do Parnaíba, Parnaíba, Brazil.'}, {'ForeName': 'Daya S', 'Initials': 'DS', 'LastName': 'Gupta', 'Affiliation': 'Department of Biology, Camden County College, Blackwood, NJ, United States.'}, {'ForeName': 'Silmar', 'Initials': 'S', 'LastName': 'Teixeira', 'Affiliation': 'Neuro-innovation Technology & Brain Mapping Laboratory, Federal University of Delta of Parnaíba, Parnaíba, Brazil; The Northeast Biotechnology Network, Federal University of Piauí, Teresina, Brazil.'}]",Physiology & behavior,['10.1016/j.physbeh.2020.113036'] 2310,32598992,Inspiratory muscle training did not improve exercise capacity and lung function in adult patients with Fontan circulation: A randomized controlled trial.,,2020,,['adult patients with Fontan circulation'],['Inspiratory muscle training'],['exercise capacity and lung function'],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C5197853', 'cui_str': 'Fontan Circuit'}]","[{'cui': 'C0454511', 'cui_str': 'Inspiratory muscle training'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}]",,0.0703325,,"[{'ForeName': 'Celina', 'Initials': 'C', 'LastName': 'Fritz', 'Affiliation': 'Department of Congenital Heart Disease and Pediatric Cardiology, Deutsches Herzzentrum München, Technical University of Munich, Germany. Electronic address: fritz@dhm.mhn.de.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Müller', 'Affiliation': 'Department of Congenital Heart Disease and Pediatric Cardiology, Deutsches Herzzentrum München, Technical University of Munich, Germany; Institute of Preventive Pediatrics, Department of Sport and Health Sciences, Technical University of Munich, Germany.'}, {'ForeName': 'Renate', 'Initials': 'R', 'LastName': 'Oberhoffer', 'Affiliation': 'Department of Congenital Heart Disease and Pediatric Cardiology, Deutsches Herzzentrum München, Technical University of Munich, Germany; Institute of Preventive Pediatrics, Department of Sport and Health Sciences, Technical University of Munich, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Ewert', 'Affiliation': 'Department of Congenital Heart Disease and Pediatric Cardiology, Deutsches Herzzentrum München, Technical University of Munich, Germany.'}, {'ForeName': 'Alfred', 'Initials': 'A', 'LastName': 'Hager', 'Affiliation': 'Department of Congenital Heart Disease and Pediatric Cardiology, Deutsches Herzzentrum München, Technical University of Munich, Germany.'}]",International journal of cardiology,['10.1016/j.ijcard.2020.06.038'] 2311,32598997,The effect of low-volume high-intensity interval training on cardiovascular health outcomes in type 2 diabetes: A randomised controlled trial.,"BACKGROUND Low-volume high-intensity interval training (HIIT) may be a time-efficient strategy that leads to similar or superior improvements in cardiorespiratory fitness (CRF) and cardiovascular disease (CVD) risk factors when compared with moderate-intensity continuous training (MICT). Our study investigated the effect of low-volume HIIT or MICT versus sham placebo-control (PLA) on central arterial stiffness, hemodynamic responses, and CVD risk factors in adults with obesity and type 2 diabetes (T2D). METHODS Eligible participants were previously inactive adults with obesity and T2D. Individuals were randomly allocated to: i) HIIT (1 × 4 min cycling at 90% peak oxygen consumption [V̇O 2peak ]); ii) MICT (45 min of cycling at 60% VO 2peak ); or PLA. Training groups exercised thrice weekly for 12 weeks. Central arterial stiffness, hemodynamics and CVD risk factors were assessed at baseline and post-intervention. Analysis of covariance (ANCOVA) was used to examine changes following HIIT, MICT and PLA. RESULTS Thirty-five participants (age: 55.1 ± 1.4 years, BMI: 36.1 ± 0.8 kg/m 2 ) completed the study. A significant intervention effect was found for changes in pulse wave velocity (PWV) (p = .05), which reduced with HIIT (-0.3 ± 0.9 m/s) and MICT (-0.1 ± 1.1 m/s) but increased with PLA (0.8 ± 1.6 m/s). There was a significant intervention effect for changes in V̇O 2peak (p < .01), glycosylated hemoglobin (p = .03), systolic blood pressure (p < .01), and waist circumference (p = .03), which all improved following MICT or HIIT but not PLA; there was no difference between MICT and HIIT. CONCLUSIONS Twelve minutes of low-volume HIIT per week leads to improvements in central arterial stiffness and cardiovascular health in inactive individuals with obesity and T2D.",2020,"A significant intervention effect was found for changes in pulse wave velocity (PWV) (p = .05), which reduced with HIIT (-0.3 ± 0.9 m/s) and MICT (-0.1 ± 1.1 m/s) but increased with PLA (0.8 ± 1.6 m/s).","['Eligible participants were previously inactive adults with obesity and T2D. Individuals', 'adults with obesity and type 2 diabetes (T2D', 'inactive individuals with obesity and T2D', 'Thirty-five participants (age: 55.1\u202f±\u202f1.4\u202fyears, BMI: 36.1\u202f±\u202f0.8\u202fkg/m 2 ) completed the study', 'type 2 diabetes']","['low-volume HIIT or MICT versus sham placebo-control (PLA', 'HIIT (1\u202f×\u202f4 min cycling at 90% peak oxygen consumption [V̇O 2peak ]); ii) MICT (45\u202fmin of cycling at 60% VO 2peak ); or PLA', 'low-volume high-intensity interval training', 'Low-volume high-intensity interval training (HIIT']","['waist circumference', 'Central arterial stiffness, hemodynamics and CVD risk factors', 'cardiovascular health outcomes', 'central arterial stiffness, hemodynamic responses, and CVD risk factors', 'cardiorespiratory fitness (CRF) and cardiovascular disease (CVD) risk factors', 'V̇O 2peak', 'glycosylated hemoglobin', 'systolic blood pressure', 'central arterial stiffness and cardiovascular health', 'pulse wave velocity (PWV']","[{'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C4319605', 'cui_str': '35'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517503', 'cui_str': '1.4'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517481', 'cui_str': '0.8'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}]","[{'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0599949', 'cui_str': 'Arterial stiffness'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C3494431', 'cui_str': 'Pulse Wave Velocity'}]",,0.0978978,"A significant intervention effect was found for changes in pulse wave velocity (PWV) (p = .05), which reduced with HIIT (-0.3 ± 0.9 m/s) and MICT (-0.1 ± 1.1 m/s) but increased with PLA (0.8 ± 1.6 m/s).","[{'ForeName': 'Kimberley L', 'Initials': 'KL', 'LastName': 'Way', 'Affiliation': 'Faculty of Medicine and Health, Discipline of Exercise and Sports Science, University of Sydney, Camperdown, NSW, Australia; The Boden Collaboration for Obesity, Nutrition, Exercise and Eating Disorders, University of Sydney, Camperdown, NSW, Australia; The Charles Perkins Centre, University of Sydney, Camperdown, NSW, Australia. Electronic address: KWay@ottawaheart.ca.'}, {'ForeName': 'Angelo', 'Initials': 'A', 'LastName': 'Sabag', 'Affiliation': 'Faculty of Medicine and Health, Discipline of Exercise and Sports Science, University of Sydney, Camperdown, NSW, Australia; The Boden Collaboration for Obesity, Nutrition, Exercise and Eating Disorders, University of Sydney, Camperdown, NSW, Australia; The Charles Perkins Centre, University of Sydney, Camperdown, NSW, Australia.'}, {'ForeName': 'Rachelle N', 'Initials': 'RN', 'LastName': 'Sultana', 'Affiliation': 'Faculty of Medicine and Health, Discipline of Exercise and Sports Science, University of Sydney, Camperdown, NSW, Australia; The Boden Collaboration for Obesity, Nutrition, Exercise and Eating Disorders, University of Sydney, Camperdown, NSW, Australia; The Charles Perkins Centre, University of Sydney, Camperdown, NSW, Australia.'}, {'ForeName': 'Michael K', 'Initials': 'MK', 'LastName': 'Baker', 'Affiliation': 'School of Exercise Science, Australian Catholic University, Strathfield, NSW, Australia.'}, {'ForeName': 'Shelley E', 'Initials': 'SE', 'LastName': 'Keating', 'Affiliation': 'Centre for Research on Exercise, Physical Activity and Health, School of Human Movement, and Nutrition Sciences, The University of Queensland, St Lucia, QLD, Australia.'}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'Lanting', 'Affiliation': 'School of Health Sciences, University of Newcastle, Ourimbah, NSW, Australia.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Gerofi', 'Affiliation': 'The Boden Collaboration for Obesity, Nutrition, Exercise and Eating Disorders, University of Sydney, Camperdown, NSW, Australia; The Charles Perkins Centre, University of Sydney, Camperdown, NSW, Australia.'}, {'ForeName': 'Vivienne H', 'Initials': 'VH', 'LastName': 'Chuter', 'Affiliation': 'Centre for Research on Exercise, Physical Activity and Health, School of Human Movement, and Nutrition Sciences, The University of Queensland, St Lucia, QLD, Australia.'}, {'ForeName': 'Ian D', 'Initials': 'ID', 'LastName': 'Caterson', 'Affiliation': 'The Boden Collaboration for Obesity, Nutrition, Exercise and Eating Disorders, University of Sydney, Camperdown, NSW, Australia; The Charles Perkins Centre, University of Sydney, Camperdown, NSW, Australia.'}, {'ForeName': 'Stephen M', 'Initials': 'SM', 'LastName': 'Twigg', 'Affiliation': 'The Charles Perkins Centre, University of Sydney, Camperdown, NSW, Australia; Central Clinical School, School of Medicine, University of Sydney, Camperdown, NSW, Australia.'}, {'ForeName': 'Nathan A', 'Initials': 'NA', 'LastName': 'Johnson', 'Affiliation': 'Faculty of Medicine and Health, Discipline of Exercise and Sports Science, University of Sydney, Camperdown, NSW, Australia; The Boden Collaboration for Obesity, Nutrition, Exercise and Eating Disorders, University of Sydney, Camperdown, NSW, Australia; The Charles Perkins Centre, University of Sydney, Camperdown, NSW, Australia.'}]",International journal of cardiology,['10.1016/j.ijcard.2020.06.019'] 2312,32599071,"A Randomized, Placebo-Controlled Trial of Pembrolizumab Plus Chemotherapy in Patients With Metastatic Squamous Non-Small-Cell Lung Cancer: Protocol-Specified Final Analysis of KEYNOTE-407.","INTRODUCTION In the randomized KEYNOTE-407 study (ClinicalTrials.gov, NCT02775435), pembrolizumab plus carboplatin and paclitaxel/nab-paclitaxel (chemotherapy) significantly improved overall survival (OS) and progression-free survival (PFS) versus placebo plus chemotherapy in patients with previously untreated metastatic squamous non-small-cell lung cancer (NSCLC). We report updated efficacy outcomes from the protocol-specified final analysis and, for the first time, progression on next-line of treatment. METHODS Eligible patients were randomized to chemotherapy plus either pembrolizumab (n=278) or placebo (n=281). After positive results from the second interim analysis, patients still receiving placebo could crossover to pembrolizumab monotherapy at time of confirmed progressive disease. Primary endpoints were OS and PFS. PFS-2 (time from randomization to progression on next-line treatment/death, whichever occurred first) was an exploratory endpoint. RESULTS After median (range) follow-up of 14.3 (0.1-31.3) months, pembrolizumab plus chemotherapy continued to demonstrate a clinically meaningful improvement over placebo plus chemotherapy in OS (median [95%CI], 17.1 [14.4‒19.9] versus 11.6 [10.1‒13.7] months; hazard ratio [HR (95%CI)], 0.71 [0.58‒0.88]) and PFS (median, 8.0 [6.3‒8.4] versus 5.1 [4.3‒6.0] months; HR [95%CI], 0.57 [0.47‒0.69]). PFS-2 was longer for patients randomized to first-line pembrolizumab plus chemotherapy (HR [95% CI], 0.59 [0.49‒0.72]). Grade 3‒5 adverse events occurred in 74.1% and 69.6% of patients receiving pembrolizumab plus chemotherapy and placebo plus chemotherapy, respectively. CONCLUSION Pembrolizumab plus chemotherapy continued to demonstrate substantially improved OS and PFS in patients with metastatic squamous NSCLC. The PFS-2 outcomes support pembrolizumab plus chemotherapy as a standard first-line treatment in patients with metastatic squamous NSCLC.",2020,"Grade 3‒5 adverse events occurred in 74.1% and 69.6% of patients receiving pembrolizumab plus chemotherapy and placebo plus chemotherapy, respectively. ","['Patients With Metastatic Squamous Non-Small-Cell Lung Cancer', 'patients with previously untreated metastatic squamous non-small-cell lung cancer (NSCLC', 'Eligible patients', 'patients with metastatic squamous NSCLC']","['chemotherapy plus either pembrolizumab', 'Placebo', 'Pembrolizumab plus chemotherapy', 'Pembrolizumab Plus Chemotherapy', 'placebo plus chemotherapy', 'pembrolizumab monotherapy', 'pembrolizumab plus carboplatin and paclitaxel/nab-paclitaxel (chemotherapy', 'pembrolizumab plus chemotherapy', 'pembrolizumab plus chemotherapy and placebo plus chemotherapy', 'placebo']","['Grade 3‒5 adverse events', 'PFS', 'OS and PFS', 'PFS-2', 'overall survival (OS) and progression-free survival (PFS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C4509816', 'cui_str': 'Squamous non-small cell lung cancer'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C1527223', 'cui_str': '130-nm albumin-bound paclitaxel'}]","[{'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",,0.574421,"Grade 3‒5 adverse events occurred in 74.1% and 69.6% of patients receiving pembrolizumab plus chemotherapy and placebo plus chemotherapy, respectively. ","[{'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Paz-Ares', 'Affiliation': 'Department of Medical Oncology, Hospital Universitario 12 de Octubre, H12o-CNIO Lung Cancer Unit, Universidad Complutense & Ciberonc, Madrid, Spain. Electronic address: lpazaresr@seom.org.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Vicente', 'Affiliation': 'Hospital Universitario Virgen Macarena, Sevilla, Spain.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Tafreshi', 'Affiliation': 'Wollongong Private Hospital and Wollongong Oncology, Wollongong, NSW, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Robinson', 'Affiliation': 'Cancer Centre of Southeastern Ontario at Kingston General Hospital, Kingston, ON, Canada.'}, {'ForeName': 'Hector Soto', 'Initials': 'HS', 'LastName': 'Parra', 'Affiliation': 'AOU Policlinico Vittorio Emanuele, Catania, Italy.'}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Mazières', 'Affiliation': 'Hôpital Larrey, Centre Hospitalier Universitaire Toulouse, Toulouse, France.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Hermes', 'Affiliation': 'Universitätskinikum Tübingen, Tuebingen, Germany.'}, {'ForeName': 'Irfan', 'Initials': 'I', 'LastName': 'Cicin', 'Affiliation': 'Department of Medical Oncology, Trakya University, Edirne, Turkey.'}, {'ForeName': 'Balazs', 'Initials': 'B', 'LastName': 'Medgyasszay', 'Affiliation': 'Veszprém Megyei Tüdőgyógyintézet Farkasgyepű, Farkasgyepű, Hungary.'}, {'ForeName': 'Jeronimo Rodríguez', 'Initials': 'JR', 'LastName': 'Cid', 'Affiliation': 'Oncology Center, Medica Sur Hospital, Mexico City, Mexico.'}, {'ForeName': 'Isamu', 'Initials': 'I', 'LastName': 'Okamoto', 'Affiliation': 'Kyushu University Hospital, Fukuoka, Japan.'}, {'ForeName': 'SungSook', 'Initials': 'S', 'LastName': 'Lee', 'Affiliation': 'Inje University College of Medicine, Busan, South Korea.'}, {'ForeName': 'Rodryg', 'Initials': 'R', 'LastName': 'Ramlau', 'Affiliation': 'Poznan University of Medical Sciences, Poznan, Poland.'}, {'ForeName': 'Vladimir', 'Initials': 'V', 'LastName': 'Vladimirov', 'Affiliation': 'State Healthcare Institute, Pyatigorsk Oncology Dispensary, Pyatigorsk, Russia.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Cheng', 'Affiliation': 'Department of Oncology, Cancer Hospital of Jilin Province, Changchun, China.'}, {'ForeName': 'Xuan', 'Initials': 'X', 'LastName': 'Deng', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Tuba', 'Initials': 'T', 'LastName': 'Bas', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Bilal', 'Initials': 'B', 'LastName': 'Piperdi', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Balazs', 'Initials': 'B', 'LastName': 'Halmos', 'Affiliation': 'Montefiore Medical Center/Albert Einstein College of Medicine, Bronx, NY, USA.'}]",Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer,['10.1016/j.jtho.2020.06.015'] 2313,32599090,THE ASSESSMENT OF DIFFERENT BLEACHING AGENTS' EFFICIENCY ON DISCOLOURED TEETH USING IMAGE-PROCESSING METHODS.,"BACKGROUND Although triple antibiotic paste (TAP) has been successfully used as an intracanal medicament for regenerative endodontic treatments, TAP has also been shown to cause discolouration. The aim of this study is to investigate the efficacy of different bleaching agents to bleach teeth discoloured from TAP. METHODS Two hundred extracted human maxillary incisors were evaluated with VITA Easyshade, and 120 teeth were prepared and discoloured by using TAP for three weeks. After colouration, 70 teeth were randomly divided into five groups: Group 1: Negative control, Group 2: Sodium perborate, Group 3: Opalescence Endo, Group 4: Endoperox, and Group 5: Biolase. The colour changes in the third and seventh days' standard images were obtained using stereomicroscopy, RGB and Lab color space transformations were applied to the images. The CIE Lab color system was used, and total color changes (ΔE) were calculated and compared among groups and over time, using analysis of variance testing. RESULTS At the third day, there was no difference between bleaching materials. At the seventh day, the Biolase group was superior to sodium perborate and there was no difference between other groups. A statistically significant difference was noted between the third and seventh-day measurements for all bleaching protocols. Bleaching effectiveness of all agents increased over time. CONCLUSIONS Teeth discoloured by using TAP may be bleached by means of the investigated protocols, and colour alteration can be increased over time. The CIE Lab colour system can be used as an alternative, in vitro test for evaluating the bleaching efficiency of bleaching agents.",2020,"The CIE Lab colour system can be used as an alternative, in vitro test for evaluating the bleaching efficiency of bleaching agents.","['Two hundred extracted human maxillary incisors were evaluated with VITA Easyshade, and 120 teeth', '70 teeth']","['triple antibiotic paste (TAP', 'Negative control, Group 2: Sodium perborate, Group 3: Opalescence Endo, Group 4: Endoperox, and Group 5: Biolase']","['time', 'Bleaching effectiveness']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0024947', 'cui_str': 'Bone structure of maxilla'}, {'cui': 'C0021156', 'cui_str': 'Structure of incisor tooth'}, {'cui': 'C0373745', 'cui_str': 'Vitamin A measurement'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}]","[{'cui': 'C0205174', 'cui_str': 'Triple'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0030634', 'cui_str': 'Pastes'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0074750', 'cui_str': 'sodium perborate'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}, {'cui': 'C0296695', 'cui_str': 'tooth-bleaching agent, Opalescence'}, {'cui': 'C0014175', 'cui_str': 'Endometriosis'}, {'cui': 'C0441876', 'cui_str': 'Group 4'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0303749', 'cui_str': 'Bleach'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",200.0,0.0177564,"The CIE Lab colour system can be used as an alternative, in vitro test for evaluating the bleaching efficiency of bleaching agents.","[{'ForeName': 'Ismail', 'Initials': 'I', 'LastName': 'Ozkocak', 'Affiliation': 'Bolu Abant Izzet Baysal University, Faculty of Dentistry, Department of Endodontics, Bolu, Turkey. Electronic address: dr_ozkocak@yahoo.com.'}, {'ForeName': 'Mahmut', 'Initials': 'M', 'LastName': 'Hekim', 'Affiliation': 'Tokat Gaziosmanpasa University, Faculty of Engineering and Natural Sciences, Department of Electrical Engineering, Tokat, Turkey. Electronic address: mahmuthekim@hotmail.com.'}, {'ForeName': 'Hakan', 'Initials': 'H', 'LastName': 'Gokturk', 'Affiliation': 'Bolu Abant Izzet Baysal University, Faculty of Dentistry, Department of Endodontics, Bolu, Turkey. Electronic address: gokturk82@hotmail.com.'}, {'ForeName': 'Kemal', 'Initials': 'K', 'LastName': 'Adem', 'Affiliation': 'Aksaray University, Faculty of Economics and Administrative Sciences, Department of Management Informatıon Systems, Aksaray, Turkey. Electronic address: kemaladem@gmail.com.'}, {'ForeName': 'Onur', 'Initials': 'O', 'LastName': 'Comert', 'Affiliation': 'Tokat Gaziosmanpasa University, Tokat Technical Sciences Vocational School, Department of Computer Technologies, Tokat, Turkey. Electronic address: onur.comert@gop.edu.tr.'}]",Photodiagnosis and photodynamic therapy,['10.1016/j.pdpdt.2020.101901'] 2314,32599148,Measuring Goal-Concordant Care: Results and reflections from secondary analysis of a trial to improve serious illness communication.,"CONTEXT Many consider goal-concordant care (GCC) to be the most important of advance care planning and palliative care. Researchers face significant challenges in attempting to measure this outcome. We conducted a randomized controlled trial to assess the effects of a system-level intervention to improve serious illness communication on goal-concordant care and other outcomes. OBJECTIVES To describe our measurement approach to GCC, present findings from a post-hoc analysis of trial data, and discuss lessons learned about measuring GCC. METHODS Using trial data collected to measure GCC we analyzed ratings and rankings from a non-validated survey of patient priorities in the setting of advanced cancer, the Life Priorities Scale, and compared outcomes with correlative measures. RESULTS Participants commonly rated several pre-determined and literature-derived priorities as important but did so in ways that were commonly incongruent with rankings. Ratings were frequently stable over time; rankings less so. Rankings are more likely to help assess the degree to which care is goal concordant but may be best augmented by corollary measures that signal achievement of a given priority. CONCLUSION Measuring GCC remains a fundamental challenge to palliative care researchers. Ratings attest to the fact that many things matter to patients, however rankings can better determine what matters most. Insights gained from our experience may guide future research aiming to utilize this outcome to assess the effect of intervention to improve serious illness care.",2020,Ratings were frequently stable over time; rankings less so.,[],"['GCC', 'system-level intervention']",[],[],"[{'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],,0.0544069,Ratings were frequently stable over time; rankings less so.,"[{'ForeName': 'Justin J', 'Initials': 'JJ', 'LastName': 'Sanders', 'Affiliation': ""Harvard Medical School, Boston, Massachusetts; Department of Psychosocial Oncology and Palliative Care, Dana-Farber Cancer Institute, Boston, Massachusetts; Ariadne Labs, Brigham and Women's Hospital & Harvard T. H. Chan School of Public Health, Boston, Massachusetts; Department of Medicine, Brigham and Women's Hospital, Boston, Massachusetts. Electronic address: jsanders@ariadnelabs.org.""}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Miller', 'Affiliation': ""Ariadne Labs, Brigham and Women's Hospital & Harvard T. H. Chan School of Public Health, Boston, Massachusetts.""}, {'ForeName': 'Meghna', 'Initials': 'M', 'LastName': 'Desai', 'Affiliation': ""Ariadne Labs, Brigham and Women's Hospital & Harvard T. H. Chan School of Public Health, Boston, Massachusetts.""}, {'ForeName': 'Olaf P', 'Initials': 'OP', 'LastName': 'Geerse', 'Affiliation': ""Ariadne Labs, Brigham and Women's Hospital & Harvard T. H. Chan School of Public Health, Boston, Massachusetts; Department of Pulmonary Diseases, Academic Medical Center, Amsterdam, The Netherlands.""}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Paladino', 'Affiliation': ""Harvard Medical School, Boston, Massachusetts; Ariadne Labs, Brigham and Women's Hospital & Harvard T. H. Chan School of Public Health, Boston, Massachusetts; Department of Medicine, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Kavanagh', 'Affiliation': ""Department of Psychosocial Oncology and Palliative Care, Dana-Farber Cancer Institute, Boston, Massachusetts; Ariadne Labs, Brigham and Women's Hospital & Harvard T. H. Chan School of Public Health, Boston, Massachusetts.""}, {'ForeName': 'Joshua R', 'Initials': 'JR', 'LastName': 'Lakin', 'Affiliation': ""Harvard Medical School, Boston, Massachusetts; Department of Psychosocial Oncology and Palliative Care, Dana-Farber Cancer Institute, Boston, Massachusetts; Department of Medicine, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Bridget A', 'Initials': 'BA', 'LastName': 'Neville', 'Affiliation': ""Ariadne Labs, Brigham and Women's Hospital & Harvard T. H. Chan School of Public Health, Boston, Massachusetts.""}, {'ForeName': 'Susan D', 'Initials': 'SD', 'LastName': 'Block', 'Affiliation': ""Harvard Medical School, Boston, Massachusetts; Department of Psychosocial Oncology and Palliative Care, Dana-Farber Cancer Institute, Boston, Massachusetts; Ariadne Labs, Brigham and Women's Hospital & Harvard T. H. Chan School of Public Health, Boston, Massachusetts; Department of Medicine, Brigham and Women's Hospital, Boston, Massachusetts; Department of Psychiatry, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Erik K', 'Initials': 'EK', 'LastName': 'Fromme', 'Affiliation': ""Harvard Medical School, Boston, Massachusetts; Department of Psychosocial Oncology and Palliative Care, Dana-Farber Cancer Institute, Boston, Massachusetts; Ariadne Labs, Brigham and Women's Hospital & Harvard T. H. Chan School of Public Health, Boston, Massachusetts; Department of Medicine, Brigham and Women's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Rachelle', 'Initials': 'R', 'LastName': 'Bernacki', 'Affiliation': ""Harvard Medical School, Boston, Massachusetts; Department of Psychosocial Oncology and Palliative Care, Dana-Farber Cancer Institute, Boston, Massachusetts; Ariadne Labs, Brigham and Women's Hospital & Harvard T. H. Chan School of Public Health, Boston, Massachusetts; Department of Medicine, Brigham and Women's Hospital, Boston, Massachusetts.""}]",Journal of pain and symptom management,['10.1016/j.jpainsymman.2020.06.023'] 2315,32594766,Carotid Atherosclerosis Evolution when Targeting a Low-Density Lipoprotein Cholesterol Concentration < 70 mg/dL after an Ischemic Stroke of Atherosclerotic Origin.,"Background: The Treat Stroke to Target (TST) trial showed the benefit of targeting a low-density lipoprotein cholesterol (LDL-C) concentration of <70 mg/dL, in term of reducing the risk of major cardiovascular events in 2860 patients with ischemic stroke with atherosclerotic stenosis of cerebral vasculature. The impact on carotid atherosclerosis evolution is not known. Methods: TST-PLUS (Treat Stroke to Target-PLaque Ultrasound Study) included 201 patients assigned to a LDL-C concentration of <70 mg/dL and 212 patients assigned to a target of 100±10 mg/dL. To achieve these goals, investigators used the statin and dosage of their choice and added ezetimibe as needed. After certification of ultra-sonographers, carotid ultrasound examinations were performed using M'ATH TM software at baseline, and at 2, 3, and 5 years. All images were up-loaded to the Intelligence in Medical Technology (IMT TM ) database directly from the carotid ultrasound device. The central core laboratory performed all off-line measurements of the intima-media thickness of both common carotid arteries blinded from the randomization arm. The main outcomes were newly diagnosed atherosclerotic plaque on carotid bifurcation or internal carotid artery origin using the definition of the Mannheim consensus definition, and the between-group comparison of common carotid arteries intima-media thickness (CCA-IMT) change. Results: After a median follow-up of 3.1 years, the achieved LDL-C concentrations were 64 mg/dL (1.64 mmol/L) in the lower-target group and 106 mg/dL (2.72 mmol/L) in the higher-target group. Compared with the higher target-group, patients in the lower target-group had a similar incidence of newly diagnosed carotid plaque: 46/201, (5-year rate, 26.1%] versus 45/212 (5-year rate, 29.7%). The change in CCA-IMT was -2.69 µm (95% CI, -6.55 to 1.18) in the higher-target group and -10.53 µm (95% CI, -14.21 to -6.85) in the lower-target group, resulting in an absolute between-group difference of -7.84 µm [95% CI, -13.18 to -2.51], P=0.004). Conclusions: In patients with ischemic stroke and atherosclerosis, an LDL-C target of <70 mg/dL (1.8 mmol/L) did not reduce the incidence of new carotid plaques but produced significantly greater regression of carotid atherosclerosis than an LDL-C target of 90 to 110 mg/dL. Clinical Trial Registration: URL: https://clinicaltrials.gov Unique Identifier: NCT01252875.",2020,"After a median follow-up of 3.1 years, the achieved LDL-C concentrations were 64 mg/dL (1.64 mmol/L) in the lower-target group and 106 mg/dL (2.72 mmol/L) in the higher-target group.","['201 patients assigned to a LDL-C concentration of <70 mg/dL and 212 patients assigned', '2860 patients with ischemic stroke with atherosclerotic stenosis of cerebral vasculature']","['statin and dosage of their choice and added ezetimibe', 'TST-PLUS']","['low-density lipoprotein cholesterol (LDL-C) concentration', 'carotid atherosclerosis', 'change in CCA-IMT', 'achieved LDL-C concentrations', 'incidence of newly diagnosed carotid plaque', 'incidence of new carotid plaques', 'newly diagnosed atherosclerotic plaque on carotid bifurcation or internal carotid artery origin', 'carotid arteries intima-media thickness (CCA-IMT) change']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0678234', 'cui_str': 'Form of stenosis'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0005839', 'cui_str': 'blood supply'}]","[{'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C1142985', 'cui_str': 'ezetimibe'}, {'cui': 'C0041290', 'cui_str': 'Delayed hypersensitivity skin test for tuberculin PPD'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0577631', 'cui_str': 'Carotid atherosclerosis'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0220668', 'cui_str': 'Congenital contractural arachnodactyly'}, {'cui': 'C0334121', 'cui_str': 'Inflammatory myofibroblastic tumor'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C2936350', 'cui_str': 'Atherosclerotic Plaques'}, {'cui': 'C0226088', 'cui_str': 'Structure of carotid bifurcation'}, {'cui': 'C0007276', 'cui_str': 'Internal carotid artery structure'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0007272', 'cui_str': 'Carotid artery structure'}, {'cui': 'C0162864', 'cui_str': 'Tunica intima'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",2860.0,0.405341,"After a median follow-up of 3.1 years, the achieved LDL-C concentrations were 64 mg/dL (1.64 mmol/L) in the lower-target group and 106 mg/dL (2.72 mmol/L) in the higher-target group.","[{'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Amarenco', 'Affiliation': 'APHP, Department of Neurology and Stroke center, Bichat Hospital, INSERM LVTS-U1148, DHU FIRE, University of Paris, Paris, France.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Hobeanu', 'Affiliation': 'APHP, Department of Neurology and Stroke center, Bichat Hospital, INSERM LVTS-U1148, DHU FIRE, University of Paris, Paris, France.'}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Labreuche', 'Affiliation': 'Université Lille, CHU Lille, EA 2694 - Santé publique : épidémiologie et qualité des soins, F-59000 Lille, France.'}, {'ForeName': 'Hugo', 'Initials': 'H', 'LastName': 'Charles', 'Affiliation': 'APHP, Department of Neurology and Stroke center, Bichat Hospital, INSERM LVTS-U1148, DHU FIRE, University of Paris, Paris, France.'}, {'ForeName': 'Maurice', 'Initials': 'M', 'LastName': 'Giroud', 'Affiliation': 'Department of Neurology, University Hospital of Dijon, University of Burgundy, Dijon, France.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Meseguer', 'Affiliation': 'APHP, Department of Neurology and Stroke center, Bichat Hospital, INSERM LVTS-U1148, DHU FIRE, University of Paris, Paris, France.'}, {'ForeName': 'Philippa C', 'Initials': 'PC', 'LastName': 'Lavallée', 'Affiliation': 'APHP, Department of Neurology and Stroke center, Bichat Hospital, INSERM LVTS-U1148, DHU FIRE, University of Paris, Paris, France.'}, {'ForeName': 'Philippe Gabriel', 'Initials': 'PG', 'LastName': 'Steg', 'Affiliation': 'APHP, Department of cardiology, INSERM LVTS-U1148, DHU FIRE, University of Paris, Hôpital Bichat, Paris, France & NHLI Imperial College, ICMS Royal Brompton Hospital London, UK.'}, {'ForeName': 'Éric', 'Initials': 'É', 'LastName': 'Vicaut', 'Affiliation': 'APHP, Department of Biostatistics, Université Paris-Diderot, Sorbonne-Paris Cité, Fernand Widal hospital, Paris, France.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Bruckert', 'Affiliation': 'APHP, Department of Endocrinology, Pitié-Salpêtrière hospital, Sorbonne University, Paris, France.'}, {'ForeName': 'Pierre-Jean', 'Initials': 'PJ', 'LastName': 'Touboul', 'Affiliation': 'APHP, Department of Neurology and Stroke center, Bichat Hospital, INSERM LVTS-U1148, DHU FIRE, University of Paris, Paris, France.'}]",Circulation,['10.1161/CIRCULATIONAHA.120.046774'] 2316,32594779,"A randomized phase I clinical trial comparing the pharmacokinetic, safety, and immunogenicity of potential biosimilar recombinant human HER2 monoclonal antibody for injection and trastuzumab in healthy Chinese adults.","OBJECTIVES Recombinant human HER2 monoclonal antibody for injection (AK-HER2) is a potential biosimilar of trastuzumab (Herceptin®). This phase Ⅰ study aimed to demonstrate the pharmacokinetic (PK) equivalence between AK-HER2 and trastuzumab in healthy volunteers. Besides, safety and immunogenicity were investigated. RESEARCH DESIGN AND METHODS This was a randomized, double-blind phase Ⅰ trial in 96 healthy adults who received a single intravenous infusion of AK-HER2 or trastuzumab at 6 mg/kg. The primary PK endpoints were area under the serum concentration curve (AUC) from time 0 to the last time point (AUC 0-t ) and peak concentration in serum (C max ). The PK bioequivalence was confirmed using the standard equivalence margins of 80%-125%. RESULTS The PK profiles of AK-HER2 and trastuzumab displayed high similarity. The geometric mean ratios (90% confidence intervals) of primary PK endpoints were within 80%-125%. The C  max  and AUC  0-t  of female subjects in the AK-HER2 group were greater than those of male subjects (P <0.05). No infusion-related reactions (IRRs) or anti-drug antibody-positivity was observed after dosing. CONCLUSIONS AK-HER2 was demonstrated to have highly similar PK to trastuzumab in healthy Chinese adults. Both drugs showed comparable safety and immunogenicity using dexamethasone as premedication to prevent IRRs..",2020,"No infusion-related reactions (IRRs) or anti-drug antibody-positivity was observed after dosing. ","['healthy Chinese adults', '96 healthy adults who received a', 'healthy volunteers']","['Recombinant human HER2 monoclonal antibody for injection (AK-HER2', 'dexamethasone', 'AK-HER2 and trastuzumab', 'biosimilar recombinant human HER2 monoclonal antibody for injection and trastuzumab', 'single intravenous infusion of AK-HER2 or trastuzumab']","['C\xa0 max \xa0and AUC\xa0 0-t', 'No infusion-related reactions (IRRs) or anti-drug antibody-positivity', 'safety and immunogenicity', 'geometric mean ratios', 'pharmacokinetic (PK) equivalence', 'area under the serum concentration curve (AUC) from time 0 to the last time point (AUC 0-t ) and peak concentration in serum (C max ']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0069515', 'cui_str': 'Oncogene protein HER-2/neu'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C4045974', 'cui_str': 'Biosimilars'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0021440', 'cui_str': 'Intravenous infusion'}]","[{'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0444505', 'cui_str': 'Peak'}]",96.0,0.163692,"No infusion-related reactions (IRRs) or anti-drug antibody-positivity was observed after dosing. ","[{'ForeName': 'Jiaxue', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': ""Department of Pharmacy, Peking University People's Hospital , Beijing, China.""}, {'ForeName': 'Suping', 'Initials': 'S', 'LastName': 'Niu', 'Affiliation': ""Department of Science and Research, Peking University People's Hospital , Beijing, China.""}, {'ForeName': 'Wenliang', 'Initials': 'W', 'LastName': 'Dong', 'Affiliation': ""Department of Pharmacy, Peking University People's Hospital , Beijing, China.""}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Wei', 'Affiliation': 'Anhui Province Key Laboratory of Gene Engineering Pharmaceutical, Anhui Anke Biotechnology (Group) Co., Ltd ., Anhui, China.'}, {'ForeName': 'Lun', 'Initials': 'L', 'LastName': 'Ou', 'Affiliation': 'United-Power Pharma Tech Co., Ltd , Beijing, China.'}, {'ForeName': 'Tan', 'Initials': 'T', 'LastName': 'Zhang', 'Affiliation': ""Department of Pharmacy, Peking University People's Hospital , Beijing, China.""}, {'ForeName': 'Liangbi', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'National and Local Joint Engineering Research Center for Precision Cancer Therapy Technology and Products, Anhui Anke Biotechnology (Group) Co., Ltd , Anhui, China.'}, {'ForeName': 'Xiaoyan', 'Initials': 'X', 'LastName': 'Nie', 'Affiliation': 'Department of Pharmacy Administration and Clinical Pharmacy, School of Pharmaceutical, Peking University , Beijing, China.'}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': ""Department of Pharmacy, Peking University People's Hospital , Beijing, China.""}, {'ForeName': 'Tiantian', 'Initials': 'T', 'LastName': 'Shen', 'Affiliation': ""Department of Pharmacy, Peking University People's Hospital , Beijing, China.""}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': ""Department of Pharmacy, Peking University People's Hospital , Beijing, China.""}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Xia', 'Affiliation': ""Department of Pharmacy, Peking University People's Hospital , Beijing, China.""}, {'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Liu', 'Affiliation': ""Department of Pharmacy, Peking University People's Hospital , Beijing, China.""}, {'ForeName': 'Jiting', 'Initials': 'J', 'LastName': 'Jin', 'Affiliation': 'National and Local Joint Engineering Research Center for Precision Cancer Therapy Technology and Products, Anhui Anke Biotechnology (Group) Co., Ltd , Anhui, China.'}, {'ForeName': 'Qingshan', 'Initials': 'Q', 'LastName': 'Zheng', 'Affiliation': 'The Center for Drug Clinical Research of Shanghai University of TCM , Shanghai, China.'}, {'ForeName': 'Haifeng', 'Initials': 'H', 'LastName': 'Song', 'Affiliation': 'Department of Pharmacology and Toxicology, Beijing Institute of Radiation Medicine , Beijing, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Fang', 'Affiliation': ""Department of Pharmacy, Peking University People's Hospital , Beijing, China.""}]",Expert opinion on investigational drugs,['10.1080/13543784.2020.1770226'] 2317,32594783,"Effect of seat height on manual wheelchair foot propulsion, a repeated-measures crossover study: part 2 - wheeling backward on a soft surface.","Purpose: The aim of this study was to test the hypotheses that, during manual-wheelchair foot propulsion backward on a soft surface, lowering the seat height increases speed, push frequency and push effectiveness, and decreases perceived difficulty. Materials and methods: In a repeated-measures crossover study, 50 able-bodied participants used one foot to propel a manual wheelchair 5 m backward on a soft surface at 5 seat heights, ranging from 5.08 cm below to about 5.08 cm above lower-leg length, in random order. We recorded Wheelchair Skills Test (WST) capacity scores and used the Wheelchair Propulsion Test (WPT) to calculate speed (m/s), push frequency (cycles/s) and push effectiveness (m/cycle). We also recorded the participants' perceived difficulty (0-4) and video-recorded each trial. Results: WST capacity scores were reduced at the higher seat heights. Using repeated-measures models (adjusted for age, sex and order), there were negative relationships between seat height and speed ( p  < 0.0001) and push effectiveness ( p  < 0.0001). Lowering the seat height by 5.08 cm below lower-leg length corresponded to improvements in speed of 0.097 m/s and in push effectiveness of 0.101 m/cycle. The trend for push frequency was also significant ( p  = 0.035) but the effect size was smaller. Perceived difficulty increased with seat height ( p  < 0.0001). The video-recordings provided qualitative kinematic data regarding the seated ""gait cycles"". Conclusions: During manual-wheelchair foot propulsion backward on a soft surface, lowering the seat height increases speed and push effectiveness, and decreases perceived difficulty.IMPLICATIONS FOR REHABILITATIONBackward wheelchair foot propulsion on soft surfaces is affected by seat height.Speed (m/s) is improved if the seat height is lowered.Push effectiveness (m/gait cycle) is improved if the seat height is lowered.Perceived difficulty of propulsion is lower if the seat height is lowered.",2020,Perceived difficulty increased with seat height ( p  < 0.0001).,[],['seat height'],"['WST capacity scores', 'seat height increases speed, push frequency and push effectiveness', 'Wheelchair Skills Test (WST) capacity scores and used the Wheelchair Propulsion Test (WPT) to calculate speed (m/s), push frequency (cycles/s) and push effectiveness (m/cycle', 'seat height', 'push frequency']",[],"[{'cui': 'C0277814', 'cui_str': 'Sitting position'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0277814', 'cui_str': 'Sitting position'}, {'cui': 'C0557899', 'cui_str': 'Height increased'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0580841', 'cui_str': 'Does push'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0043143', 'cui_str': 'Wheelchair'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0444686', 'cui_str': 'Calculated'}, {'cui': 'C0439493', 'cui_str': 'm/s'}, {'cui': 'C0439482', 'cui_str': 'Hz'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}]",50.0,0.0266554,Perceived difficulty increased with seat height ( p  < 0.0001).,"[{'ForeName': 'Nathaniel David', 'Initials': 'ND', 'LastName': 'Heinrichs', 'Affiliation': 'Division of Physical Medicine and Rehabilitation, Department of Medicine, Dalhousie University, Halifax, Canada.'}, {'ForeName': 'Ronald Lee', 'Initials': 'RL', 'LastName': 'Kirby', 'Affiliation': 'Division of Physical Medicine and Rehabilitation, Department of Medicine, Dalhousie University, Halifax, Canada.'}, {'ForeName': 'Cher', 'Initials': 'C', 'LastName': 'Smith', 'Affiliation': 'Department of Occupational Therapy, Nova Scotia Health Authority, Halifax, Canada.'}, {'ForeName': 'Kristin Frances Joyce', 'Initials': 'KFJ', 'LastName': 'Russell', 'Affiliation': 'Department of Occupational Therapy, Nova Scotia Health Authority, Halifax, Canada.'}, {'ForeName': 'Christopher John', 'Initials': 'CJ', 'LastName': 'Theriault', 'Affiliation': 'Research Methods Unit, Nova Scotia Health Authority, Halifax, Canada.'}, {'ForeName': 'Steve Paul', 'Initials': 'SP', 'LastName': 'Doucette', 'Affiliation': 'Research Methods Unit, Nova Scotia Health Authority, Halifax, Canada.'}]",Disability and rehabilitation. Assistive technology,['10.1080/17483107.2020.1782490'] 2318,32594785,"Influence of timolol, benzalkonium-preserved timolol, and benzalkonium-preserved brimonidine on oxidative stress biomarkers in the tear film.","Purpose: The objective of this study was to investigate the influence of topical preservative-free timolol, benzalkonium chloride(BAC)-preserved timolol, BAC-preserved timolol, and BAC-preserved brimonidine on total protein concentration, advanced oxidation protein products (AOPP) content, total sulfhydryl groups content, the activity of superoxide dismutase (SOD), catalase (CAT), and glutathione peroxidase (GPx), as well as Total Oxidant Status (TOS), Total Antioxidant Response, and Oxidative Stress Index (OSI) in the tear film. Methods: The patients were divided into four groups: group C (n = 25)-control group-subjects who did not use topical antiglaucoma medications, group T (n = 17)-patients using topical preservative-free timolol, group T + BAC (n = 24)-patients using topical BAC-preserved timolol, and group BR + BAC (n = 19)-patients using topical BAC-preserved brimonidine. Results: The SOD, CAT, and GPx activities as well as AOPP, TOS, and OSI were found to be higher in the tear film of patients treated with BAC-preserved topical timolol or brimonidine in comparison with patients treated with preservative-free timolol or patients who did not use antiglaucoma topical medications. Conclusions: This indicates that using BAC-preserved topical medications increases oxidative stress in the tear film and may, in the long-term, contribute to the clinical presentation of dry eye disease.",2020,"Results: The SOD, CAT, and GPx activities as well as AOPP, TOS, and OSI were found to be higher in the tear film of patients treated with BAC-preserved topical timolol or brimonidine in comparison with patients treated with preservative-free timolol or patients who did not use antiglaucoma topical medications.",[],"['preservative-free timolol', 'BAC-preserved topical medications', '25)-control group-subjects who did not use topical antiglaucoma medications, group T (n\u2009=\u200917)-patients using topical preservative-free timolol, group T\u2009+\u2009BAC (n\u2009=\u200924)-patients using topical BAC-preserved timolol, and group BR\u2009+\u2009BAC (n\u2009=\u200919)-patients using topical BAC-preserved brimonidine', 'brimonidine', 'timolol, benzalkonium-preserved timolol, and benzalkonium-preserved brimonidine', 'topical preservative-free timolol, benzalkonium chloride(BAC)-preserved timolol, BAC-preserved timolol, and BAC-preserved brimonidine']","['SOD, CAT, and GPx activities as well as AOPP, TOS, and OSI', 'total protein concentration, advanced oxidation protein products (AOPP) content, total sulfhydryl groups content, the activity of superoxide dismutase (SOD), catalase (CAT), and glutathione peroxidase (GPx), as well as Total Oxidant Status (TOS), Total Antioxidant Response, and Oxidative Stress Index (OSI', 'oxidative stress', 'oxidative stress biomarkers']",[],"[{'cui': 'C0033086', 'cui_str': 'Drug preservative'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0040233', 'cui_str': 'Timolol'}, {'cui': 'C0004599', 'cui_str': 'Bacitracin'}, {'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0036669', 'cui_str': 'Group T'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0525227', 'cui_str': 'brimonidine'}, {'cui': 'C0005025', 'cui_str': 'Benzalkonium'}, {'cui': 'C0005026', 'cui_str': 'Benzalkonium chloride'}]","[{'cui': 'C0038838', 'cui_str': 'Superoxide Dismutase'}, {'cui': 'C0007366', 'cui_str': 'Catalan language'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0039984', 'cui_str': 'Thoracic outlet syndrome'}, {'cui': 'C0555903', 'cui_str': 'Total protein measurement'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C1976991', 'cui_str': 'Advanced oxidation protein products'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0038734', 'cui_str': 'Sulfhydryls'}, {'cui': 'C0007367', 'cui_str': 'CATALASE'}, {'cui': 'C0017822', 'cui_str': 'Glutathione peroxidase'}, {'cui': 'C0085403', 'cui_str': 'Oxidizing Agents'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}]",,0.0166171,"Results: The SOD, CAT, and GPx activities as well as AOPP, TOS, and OSI were found to be higher in the tear film of patients treated with BAC-preserved topical timolol or brimonidine in comparison with patients treated with preservative-free timolol or patients who did not use antiglaucoma topical medications.","[{'ForeName': 'Lech', 'Initials': 'L', 'LastName': 'Sedlak', 'Affiliation': 'Department of Ophthalmology, Faculty of Medical Sciences in Katowice, Medical University of Silesia in Katowice, Poland.'}, {'ForeName': 'Weronika', 'Initials': 'W', 'LastName': 'Wojnar', 'Affiliation': 'Department of Pharmacognosy and Phytochemistry, Faculty of Pharmaceutical Sciences in Sosnowiec, Medical University of Silesia in Katowice, Poland.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Zych', 'Affiliation': 'Department of Pharmacognosy and Phytochemistry, Faculty of Pharmaceutical Sciences in Sosnowiec, Medical University of Silesia in Katowice, Poland.'}, {'ForeName': 'Dorota', 'Initials': 'D', 'LastName': 'Wyględowska-Promieńska', 'Affiliation': 'Department of Ophthalmology, Faculty of Medical Sciences in Katowice, Medical University of Silesia in Katowice, Poland.'}]",Cutaneous and ocular toxicology,['10.1080/15569527.2020.1787435'] 2319,32594786,Intralesional betamethasone versus triamcinolone acetonide in the treatment of localized alopecia areata: a within-patient randomized controlled trial.,"Background: Betamethasone can be used for intralesional infiltration, but there is little evidence in the literature to indicate its effectiveness in alopecia areata. Objective: To assess the safety and effectiveness of the use of different doses of intralesional betamethasone, when compared to triamcinolone acetonide for the treatment of alopecia areata. Methods: We recruited 12 patients with alopecia patch divided into four quadrants. Each quadrant, after randomization, received an intralesional injection with one of the following treatments: triamcinolone acetonide 2.5 mg/ml, betamethasone 0.375mg/ml, betamethasone 1.75mg/ml, or 0.9% saline (placebo). The intervention was repeated in the same quadrant every 4 weeks, totaling 3 sessions. Visual and dermoscopic evaluation of the results were performed. Trial registration: ReBec RBR-5kyg2r. Results: At 4 and 8 weeks of intervention, triamcinolone acetonide 2.5 mg/ml provided the best visual results. Nevertheless, at the end of the study, the best visual results were seen with both triamcinolone acetonide and betamethasone 1.75mg/ml, with significant difference when compared to betamethasone 0.375mg/ml and placebo (p=.0489 and <.0001, respectively). There was a progressive reduction in the number of dystrophic hairs in all quadrants. Conclusion: Triamcinolone acetonide shows earlier results in repilation, but at 12 weeks betamethasone 1.75mg/ml had similar results.",2020,There was a progressive reduction in the number of dystrophic hairs in all quadrants.,"['localized alopecia areata', '12 patients with alopecia patch divided into four quadrants', 'alopecia areata']","['triamcinolone acetonide 2.5\u2009mg/ml, betamethasone 0.375mg/ml, betamethasone 1.75mg', 'betamethasone', 'Intralesional betamethasone versus triamcinolone acetonide', 'triamcinolone acetonide 2.5\u2009mg/ml', 'saline (placebo', 'intralesional betamethasone', 'Betamethasone', 'triamcinolone acetonide', 'Triamcinolone acetonide', 'placebo']","['safety and effectiveness', 'number of dystrophic hairs']","[{'cui': 'C0002170', 'cui_str': 'Alopecia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332461', 'cui_str': 'Plaque'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439738', 'cui_str': 'Four quadrants'}]","[{'cui': 'C0040866', 'cui_str': 'Triamcinolone acetonide'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0439294', 'cui_str': 'g/L'}, {'cui': 'C0005308', 'cui_str': 'Betamethasone'}, {'cui': 'C4517514', 'cui_str': '1.75'}, {'cui': 'C1512955', 'cui_str': 'Intralesional route'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0544849', 'cui_str': 'Hair dystrophy'}]",12.0,0.111164,There was a progressive reduction in the number of dystrophic hairs in all quadrants.,"[{'ForeName': 'Vando', 'Initials': 'V', 'LastName': 'Sousa', 'Affiliation': 'Universidade Federal do Ceará, Sobral, Ceará, Brasil.'}, {'ForeName': 'Francisco Placido', 'Initials': 'FP', 'LastName': 'Arcanjo', 'Affiliation': 'Universidade Federal do Ceará, Sobral, Ceará, Brasil.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Aguiar', 'Affiliation': 'Universidade Federal do Piauí, Parnaíba, Piaauí, Brasil.'}, {'ForeName': 'Jaqueline', 'Initials': 'J', 'LastName': 'Vasconcelos', 'Affiliation': 'Universidade do Estado do Rio de Janeiro, Rio de Janeiro, Brasil.'}, {'ForeName': 'Antonio Flavio', 'Initials': 'AF', 'LastName': 'Oliveira', 'Affiliation': 'Universidade Federal do Ceará, Sobral, Ceará, Brasil.'}, {'ForeName': 'Aline', 'Initials': 'A', 'LastName': 'Honório', 'Affiliation': 'Centro Universitário INTA, Sobral, Ceará, Brasil.'}, {'ForeName': 'Juliana', 'Initials': 'J', 'LastName': 'Pontes', 'Affiliation': 'Centro Universitário INTA, Sobral, Ceará, Brasil.'}]",The Journal of dermatological treatment,['10.1080/09546634.2020.1788703'] 2320,32594789,"Mindfulness, Education, and Exercise for age-related cognitive decline: Study protocol, pilot study results, and description of the baseline sample.","BACKGROUND/AIMS Age-related cognitive decline is a pervasive problem in our aging population. To date, no pharmacological treatments to halt or reverse cognitive decline are available. Behavioral interventions, such as physical exercise and Mindfulness-Based Stress Reduction, may reduce or reverse cognitive decline, but rigorously designed randomized controlled trials are needed to test the efficacy of such interventions. METHODS Here, we describe the design of the Mindfulness, Education, and Exercise study, an 18-month randomized controlled trial that will assess the effect of two interventions-mindfulness training plus moderate-to-vigorous intensity exercise or moderate-to-vigorous intensity exercise alone-compared with a health education control group on cognitive function in older adults. An extensive battery of biobehavioral assessments will be used to understand the mechanisms of cognitive remediation, by using structural and resting state functional magnetic resonance imaging, insulin sensitivity, inflammation, and metabolic and behavioral assessments. RESULTS We provide the results from a preliminary study (n = 29) of non-randomized pilot participants who received both the exercise and Mindfulness-Based Stress Reduction interventions. We also provide details on the recruitment and baseline characteristics of the randomized controlled trial sample (n = 585). CONCLUSION When complete, the Mindfulness, Education, and Exercise study will inform the research community on the efficacy of these widely available interventions improve cognitive functioning in older adults.",2020,"Behavioral interventions, such as physical exercise and Mindfulness-Based Stress Reduction, may reduce or reverse cognitive decline, but rigorously designed randomized controlled trials are needed to test the efficacy of such interventions. ",['older adults'],"['interventions-mindfulness training plus moderate-to-vigorous intensity exercise or moderate-to-vigorous intensity exercise alone-compared with a health education control group', 'exercise and Mindfulness-Based Stress Reduction interventions', 'Behavioral interventions, such as physical exercise and Mindfulness-Based Stress Reduction']","['cognitive function', 'cognitive functioning']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}]","[{'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}]",,0.118193,"Behavioral interventions, such as physical exercise and Mindfulness-Based Stress Reduction, may reduce or reverse cognitive decline, but rigorously designed randomized controlled trials are needed to test the efficacy of such interventions. ","[{'ForeName': 'Julie Loebach', 'Initials': 'JL', 'LastName': 'Wetherell', 'Affiliation': 'VA San Diego Healthcare System, San Diego, CA, USA.'}, {'ForeName': 'Hayley S', 'Initials': 'HS', 'LastName': 'Ripperger', 'Affiliation': 'Department of Psychiatry, School of Medicine, Washington University in St. Louis, St. Louis, MO, USA.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Voegtle', 'Affiliation': 'Department of Psychiatry, School of Medicine, Washington University in St. Louis, St. Louis, MO, USA.'}, {'ForeName': 'Beau M', 'Initials': 'BM', 'LastName': 'Ances', 'Affiliation': 'Department of Neurology, School of Medicine, Washington University in St. Louis, St. Louis, MO, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Balota', 'Affiliation': 'Department of Psychological and Brain Sciences, Washington University in St. Louis, St. Louis, MO, USA.'}, {'ForeName': 'Emily S', 'Initials': 'ES', 'LastName': 'Bower', 'Affiliation': 'University of California San Diego, San Diego, CA, USA.'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'Depp', 'Affiliation': 'VA San Diego Healthcare System, San Diego, CA, USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Eyler', 'Affiliation': 'University of California San Diego, San Diego, CA, USA.'}, {'ForeName': 'Erin R', 'Initials': 'ER', 'LastName': 'Foster', 'Affiliation': 'Department of Psychiatry, School of Medicine, Washington University in St. Louis, St. Louis, MO, USA.'}, {'ForeName': 'Denise', 'Initials': 'D', 'LastName': 'Head', 'Affiliation': 'Department of Psychological and Brain Sciences, Washington University in St. Louis, St. Louis, MO, USA.'}, {'ForeName': 'Tamara', 'Initials': 'T', 'LastName': 'Hershey', 'Affiliation': 'Department of Psychiatry, School of Medicine, Washington University in St. Louis, St. Louis, MO, USA.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Hickman', 'Affiliation': 'University of California San Diego, San Diego, CA, USA.'}, {'ForeName': 'Noralinda', 'Initials': 'N', 'LastName': 'Kamantigue', 'Affiliation': 'University of California San Diego, San Diego, CA, USA.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Klein', 'Affiliation': 'Center for Human Nutrition, School of Medicine, Washington University in St. Louis, St. Louis, MO, USA.'}, {'ForeName': 'J Philip', 'Initials': 'JP', 'LastName': 'Miller', 'Affiliation': 'Division of Biostatistics, School of Medicine, Washington University in St. Louis, St. Louis, MO, USA.'}, {'ForeName': 'Michael D', 'Initials': 'MD', 'LastName': 'Yingling', 'Affiliation': 'Department of Psychiatry, School of Medicine, Washington University in St. Louis, St. Louis, MO, USA.'}, {'ForeName': 'Jeanne', 'Initials': 'J', 'LastName': 'Nichols', 'Affiliation': 'University of California San Diego, San Diego, CA, USA.'}, {'ForeName': 'Ginger E', 'Initials': 'GE', 'LastName': 'Nicol', 'Affiliation': 'Department of Psychiatry, School of Medicine, Washington University in St. Louis, St. Louis, MO, USA.'}, {'ForeName': 'Bruce W', 'Initials': 'BW', 'LastName': 'Patterson', 'Affiliation': 'Center for Human Nutrition, School of Medicine, Washington University in St. Louis, St. Louis, MO, USA.'}, {'ForeName': 'Thomas L', 'Initials': 'TL', 'LastName': 'Rodebaugh', 'Affiliation': 'Department of Psychological and Brain Sciences, Washington University in St. Louis, St. Louis, MO, USA.'}, {'ForeName': 'Joshua S', 'Initials': 'JS', 'LastName': 'Shimony', 'Affiliation': 'Mallinckrodt Institute of Radiology, School of Medicine, Washington University in St. Louis, St. Louis, MO, USA.'}, {'ForeName': 'Abraham', 'Initials': 'A', 'LastName': 'Snyder', 'Affiliation': 'Mallinckrodt Institute of Radiology, School of Medicine, Washington University in St. Louis, St. Louis, MO, USA.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Stephens', 'Affiliation': 'Department of Psychiatry, School of Medicine, Washington University in St. Louis, St. Louis, MO, USA.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Tate', 'Affiliation': 'University of California San Diego, San Diego, CA, USA.'}, {'ForeName': 'Mary L', 'Initials': 'ML', 'LastName': 'Uhrich', 'Affiliation': 'Department of Psychiatry, School of Medicine, Washington University in St. Louis, St. Louis, MO, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Wing', 'Affiliation': 'University of California San Diego, San Diego, CA, USA.'}, {'ForeName': 'Gregory F', 'Initials': 'GF', 'LastName': 'Wu', 'Affiliation': 'Department of Neurology, School of Medicine, Washington University in St. Louis, St. Louis, MO, USA.'}, {'ForeName': 'Eric J', 'Initials': 'EJ', 'LastName': 'Lenze', 'Affiliation': 'Department of Psychiatry, School of Medicine, Washington University in St. Louis, St. Louis, MO, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Clinical trials (London, England)",['10.1177/1740774520931864'] 2321,32594817,"Association between septoplasty, Lund-Mackay score and Lund-Kennedy score with endoscopic dacryocystorhinostomy results.","PURPOSE To compare endoscopic dacryocystorhinostomy (endo-DCR) + septoplasty with endo-DCR alone and determine the relationship between sinusitis and endo-DCR surgery results. METHODS Our study included 55 patients with nasolacrimal duct obstruction (NLDO) between June 2017 and June 2019. Patients were divided into two groups as endo-DCR alone and endo-DCR + septoplasty. Patients' symptoms were thoroughly evaluated and scored using the Lund-Mackay (LM) score and the Lund-Kennedy (LK) system. According to LK endoscopy scoring; those with a score of 0 were determined as group 1 (40 (58.8%) cases); and those with a score greater than 0 were determined as group 2 (28(41.2%) cases). According to LM CT scoring system, cases whose score was 0 were determined as group 1 (44(%66.2) cases); those greater than 0 were determined as group 2 (23(33.8%) cases). RESULTS A total of 68 endo-DCR surgeries, 42 unilateral and 13 bilateral, were performed. Forty one cases (60.3%) were managed with endo-DCR alone, and septoplasty surgery was performed in 27 (39.7%) cases in addition to endo-DCR due to septum deviation. There was no statistically significant difference in functional and anatomical success between the two groups in terms of surgery type (anatomical success p = .353, functional success p = .528); LK endoscopy scoring (anatomical success p = .956, functional success p = .925) and LM CT scoring system (anatomical success p = .202, functional success p = .172). CONCLUSION LK endoscopy and LM CT scores did not show any influence on functional and anatomic outcomes in endo-DCR cases.",2020,"There was no statistically significant difference in functional and anatomical success between the two groups in terms of surgery type (anatomical success p = .353, functional success p = .528); LK endoscopy scoring (anatomical success ","['55 patients with nasolacrimal duct obstruction (NLDO) between June 2017 and June 2019', 'A total of 68 endo-DCR surgeries, 42 unilateral and 13 bilateral, were performed']","['endo-DCR alone and endo-DCR + septoplasty', 'endoscopic dacryocystorhinostomy (endo-DCR) + septoplasty with endo-DCR alone']","['LM CT scoring system ', 'Lund-Mackay (LM) score and the Lund-Kennedy (LK) system', 'LK endoscopy scoring (anatomical success', 'functional and anatomic outcomes', 'LK endoscopy and LM CT scores', 'functional success', 'functional and anatomical success']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1281931', 'cui_str': 'Obstruction of nasolacrimal duct'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0395256', 'cui_str': 'Intranasal dacryocystorhinostomy'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C0395256', 'cui_str': 'Intranasal dacryocystorhinostomy'}, {'cui': 'C0844334', 'cui_str': 'Septoplasty'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0220784', 'cui_str': 'Anatomic'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",55.0,0.013691,"There was no statistically significant difference in functional and anatomical success between the two groups in terms of surgery type (anatomical success p = .353, functional success p = .528); LK endoscopy scoring (anatomical success ","[{'ForeName': 'Sercan', 'Initials': 'S', 'LastName': 'Cikrikci', 'Affiliation': 'Department of Otolaryngology, Head and Neck Surgery, Yozgat City Hospital , Yozgat, Turkey.'}, {'ForeName': 'Erol', 'Initials': 'E', 'LastName': 'Erkan', 'Affiliation': 'Department of Ophthalmology, Yozgat City Hospital , Yozgat, Turkey.'}, {'ForeName': 'Fatih', 'Initials': 'F', 'LastName': 'Agdas', 'Affiliation': 'Department of Otolaryngology, Head and Neck Surgery, Yozgat City Hospital , Yozgat, Turkey.'}]","Orbit (Amsterdam, Netherlands)",['10.1080/01676830.2020.1782441'] 2322,32595055,The efficacy of intravenous lidocaine and its side effects in comparison with intravenous morphine sulfate in patients admitted to the ED with right upper abdominal pain suspected of biliary colic.,"BACKGROUND Intravenous (IV) Lidocaine can be used as analgesic in acute pain management in the emergency department (ED). OBJECTIVE Efficacy of IV Lidocaine in comparison with IV morphine in acute pain management in the ED. METHOD This is a double-blind randomized clinical trial on adult (18-64 year) patients with right upper abdominal pain suspected of biliary colic who needed pain management. Participants randomly received IV lidocaine (5 cc = 100 mg) or morphine sulfate (5 cc = 5 mg). In both groups, patients' pain scores were recorded and assessed by Numeric Rating Scale (NRS) at baseline, 10, 20, 30, 45, 60 and 120 min after drug administration. Adverse side effects of lidocaine and morphine sulfate and changes in vital signs were also recorded and compared. RESULTS A total number of 104 patients were enrolled in the study, including 49 men and 55 women. IV lidocaine reduced pain in less time in comparison with morphine sulfate. Mean (±SD) basic pain score was 8.23 (±1.76) in the lidocaine group and 8.73 (±0.96) in the morphine group. Patients' mean (±SD) pain score in both groups had no significant difference during the study except that of NRS2 (10 min after drug administration), which was 5.05 (±2.69) in lidocaine group compared with 6.39 (±2.06) in the morphine group and NRS4 (30 min after drug administration), which was significantly lower (P-value = 0.01) in the morphine group [3.84(±1.73) vs 4.41(±2.82)]. Only 9 patients had adverse effects in either group. CONCLUSION The findings of this study suggest that IV lidocaine can be a good choice in pain management in biliary colic and can reduce pain in less time than morphine sulfate (in 10 min) without adding significant side effects; however, our primary outcome was the comparison of these two drugs after 60 min of drug administration in pain reduction which showed no significant difference between two groups.",2020,"Patients' mean (±SD) pain score in both groups had no significant difference during the study except that of NRS2 (10 min after drug administration), which was 5.05 (±2.69) in lidocaine group compared with 6.39 (±2.06) in the morphine group and NRS4 (30 min after drug administration), which was significantly lower (P-value = 0.01) in the morphine group [3.84(±1.73) vs 4.41(±2.82)].","['patients admitted to the ED with right upper abdominal pain suspected of biliary colic', 'acute pain management in the ED', 'A total number of 104 patients were enrolled in the study, including 49 men and 55 women', 'adult (18-64\xa0year) patients with right upper abdominal pain suspected of biliary colic who needed pain management']","['lidocaine and morphine sulfate', 'Lidocaine', 'lidocaine', 'morphine sulfate', 'IV lidocaine', 'morphine']","['Numeric Rating Scale (NRS', 'pain scores', 'vital signs', 'basic pain score', 'pain reduction', 'NRS4', ""Patients' mean (±SD) pain score"", 'pain', 'adverse effects', 'Mean (±SD']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0232492', 'cui_str': 'Upper abdominal pain'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0151824', 'cui_str': 'Biliary colic'}, {'cui': 'C0184567', 'cui_str': 'Acute pain'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}]","[{'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0066814', 'cui_str': 'Morphine sulfate'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",,0.178791,"Patients' mean (±SD) pain score in both groups had no significant difference during the study except that of NRS2 (10 min after drug administration), which was 5.05 (±2.69) in lidocaine group compared with 6.39 (±2.06) in the morphine group and NRS4 (30 min after drug administration), which was significantly lower (P-value = 0.01) in the morphine group [3.84(±1.73) vs 4.41(±2.82)].","[{'ForeName': 'Atousa', 'Initials': 'A', 'LastName': 'Akhgar', 'Affiliation': 'Emergency Medicine Department, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Tayebe', 'Initials': 'T', 'LastName': 'Pouryousefi', 'Affiliation': 'Emergency Medicine Department, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Nejati', 'Affiliation': 'Pre-Hospital and Hospital Emergency Research Center, Emergency Medicine Department, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hosein', 'Initials': 'H', 'LastName': 'Rafiemanesh', 'Affiliation': 'Department of Epidemiology, School of Public Health and Safety, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hooman', 'Initials': 'H', 'LastName': 'Hossein-Nejad', 'Affiliation': 'Emergency Medicine Department, Tehran University of Medical Sciences, Tehran, Iran. Electronic address: hoseinnejad@tums.ac.ir.'}]",The American journal of emergency medicine,['10.1016/j.ajem.2020.04.010'] 2323,32595083,Family Mealtime Communication in Single- and Dual-Headed Households Among Hispanic Adolescents With Overweight and Obesity.,"OBJECTIVE To investigate the association of adolescent self-report of family mealtime communication on obesity-related behaviors in single- and dual-parent households and by sex in a sample of overweight and obese Hispanic adolescents. DESIGN Cross-sectional analysis of a randomized control trial SETTING: Eighteen middle schools in Miami-Dade County, Florida. PARTICIPANTS Two-hundred and eighty Hispanic seventh- and eighth-grade students MAIN OUTCOME MEASURES: Physical activity, fruit and vegetable intake, and added sugar intake. ANALYSIS Structural equation modeling. RESULTS The findings indicate that mealtime communication was associated with fruit and vegetable consumption in boys (β = .30; P = .001; 95% confidence interval [CI], 0.52-2.68) and physical activity in girls (β = .26; P = .010; 95% CI, 0.16-1.30). Moreover, a single-parent household was associated with dietary consumption in boys (fruit and vegetable intake [β= .18; P = .039; 95% CI, 0.02-2.60] but had a moderating effect on fruit and vegetable consumption in girls (β = .21; P = .015; 95% CI, 0.14-2.19). CONCLUSIONS AND IMPLICATIONS Family mealtime communication may impact dietary and physical activity outcomes in Hispanic adolescents with overweight and obesity, but differentially across gender and household parent makeup. These findings, together with the prevalence of single parents, point to the importance of targeting Hispanic single parents as agents of change to promote healthy lifestyle behaviors in their children via positive mealtime interactions.",2020,"The findings indicate that mealtime communication was associated with fruit and vegetable consumption in boys (β = .30; P = .001; 95% confidence interval [CI], 0.52-2.68) and physical activity in girls (β = .26; P = .010; 95% CI, 0.16-1.30).","['single- and dual-parent households and by sex in a sample of overweight and obese Hispanic adolescents', 'Hispanic Adolescents With Overweight and Obesity', 'Two-hundred and eighty Hispanic seventh- and eighth-grade students', 'Eighteen middle schools in Miami-Dade County, Florida', 'Hispanic adolescents with overweight and obesity']",['family mealtime communication'],"['fruit and vegetable consumption', 'physical activity', 'Physical activity, fruit and vegetable intake, and added sugar intake', 'healthy lifestyle behaviors']","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0205441', 'cui_str': 'Seventh'}, {'cui': 'C0205442', 'cui_str': 'Eighth'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C0557797', 'cui_str': 'Middle school'}, {'cui': 'C0046889', 'cui_str': ""3,3'-diallyldiethylstilbestrol""}, {'cui': 'C0016253', 'cui_str': 'Florida'}]","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0587119', 'cui_str': 'Mealtimes'}, {'cui': 'C0009452', 'cui_str': 'Communication'}]","[{'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C1271941', 'cui_str': 'Fruit and vegetable intake'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0556234', 'cui_str': 'Sugar intake'}, {'cui': 'C4277664', 'cui_str': 'Healthy Lifestyles'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]",280.0,0.0816013,"The findings indicate that mealtime communication was associated with fruit and vegetable consumption in boys (β = .30; P = .001; 95% confidence interval [CI], 0.52-2.68) and physical activity in girls (β = .26; P = .010; 95% CI, 0.16-1.30).","[{'ForeName': 'Cynthia N', 'Initials': 'CN', 'LastName': 'Lebron', 'Affiliation': 'Department of Public Health Sciences, University of Miami Miller School of Medicine, Miami, FL. Electronic address: Clebron@med.miami.edu.'}, {'ForeName': 'Yaray', 'Initials': 'Y', 'LastName': 'Agosto', 'Affiliation': 'Department of Health Promotion and Disease Prevention, Robert Stempel College of Public Health and Social Work, Florida International University, Miami, FL.'}, {'ForeName': 'Tae K', 'Initials': 'TK', 'LastName': 'Lee', 'Affiliation': 'Department of Public Health Sciences, University of Miami Miller School of Medicine, Miami, FL.'}, {'ForeName': 'Guillermo', 'Initials': 'G', 'LastName': 'Prado', 'Affiliation': 'Department of Public Health Sciences, University of Miami Miller School of Medicine, Miami, FL.'}, {'ForeName': 'Sara M St', 'Initials': 'SMS', 'LastName': 'George', 'Affiliation': 'Department of Public Health Sciences, University of Miami Miller School of Medicine, Miami, FL.'}, {'ForeName': 'Hilda', 'Initials': 'H', 'LastName': 'Pantin', 'Affiliation': 'Department of Public Health Sciences, University of Miami Miller School of Medicine, Miami, FL.'}, {'ForeName': 'Sarah E', 'Initials': 'SE', 'LastName': 'Messiah', 'Affiliation': ""University of Texas Health Science Center, School of Public Health, Dallas, TX; Center for Pediatric Population Health, Children's Health System of Texas and UTHealth School of Public Health, Dallas, TX.""}]",Journal of nutrition education and behavior,['10.1016/j.jneb.2020.03.003'] 2324,32595137,Evaluation of the General Practice Pharmacist (GPP) intervention to optimise prescribing in Irish primary care: a non-randomised pilot study.,"OBJECTIVE Limited evidence suggests integration of pharmacists into the general practice team could improve medicines management for patients, particularly those with multimorbidity and polypharmacy. This study aimed to develop and assess the feasibility of an intervention involving pharmacists, working within general practices, to optimise prescribing in Ireland. DESIGN Non-randomised pilot study. SETTING Primary care in Ireland. PARTICIPANTS Four general practices, purposively sampled and recruited to reflect a range of practice sizes and demographic profiles. INTERVENTION A pharmacist joined the practice team for 6 months (10 hours/week) and undertook medication reviews (face to face or chart based) for adult patients, provided prescribing advice, supported clinical audits and facilitated practice-based education. OUTCOME MEASURES Anonymised practice-level medication (eg, medication changes) and cost data were collected. Patient-reported outcome measure (PROM) data were collected on a subset of older adults (aged ≥65 years) with polypharmacy using patient questionnaires, before and 6 weeks after medication review by the pharmacist. RESULTS Across four practices, 786 patients were identified as having 1521 prescribing issues by the pharmacists. Issues relating to deprescribing medications were addressed most often by the prescriber (59.8%), compared with cost-related issues (5.8%). Medication changes made during the study equated to approximately €57 000 in cost savings assuming they persisted for 12 months. Ninety-six patients aged ≥65 years with polypharmacy were recruited from the four practices for PROM data collection and 64 (66.7%) were followed up. There were no changes in patients' treatment burden or attitudes to deprescribing following medication review, and there were conflicting changes in patients' self-reported quality of life. CONCLUSIONS This non-randomised pilot study demonstrated that an intervention involving pharmacists, working within general practices is feasible to implement and has potential to improve prescribing quality. This study provides rationale to conduct a randomised controlled trial to evaluate the clinical and cost-effectiveness of this intervention.",2020,"There were no changes in patients' treatment burden or attitudes to deprescribing following medication review, and there were conflicting changes in patients' self-reported quality of life. ","['Ninety-six patients aged ≥65 years with polypharmacy were recruited from the four practices for PROM data collection and 64 (66.7%) were followed up', 'Irish primary care', '786 patients were identified as having 1521 prescribing issues by the pharmacists', 'Primary care in Ireland', 'Four general practices, purposively sampled and recruited to reflect a range of practice sizes and demographic profiles']",['General Practice Pharmacist (GPP) intervention'],"['quality of life', 'Anonymised practice-level medication (eg, medication changes) and cost data']","[{'cui': 'C4319625', 'cui_str': '96'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C2922974', 'cui_str': 'Polypharmacy'}, {'cui': 'C4277735', 'cui_str': 'Patient Reported Outcome Measures'}, {'cui': 'C0010995', 'cui_str': 'Data Collection'}, {'cui': 'C4517843', 'cui_str': '66.7'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C1553352', 'cui_str': 'Irish Gaelic language'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C2239117', 'cui_str': 'Prescription of drug'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0031323', 'cui_str': 'Pharmacist'}, {'cui': 'C0022067', 'cui_str': 'Republic of Ireland'}, {'cui': 'C0015607', 'cui_str': 'Family practice'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0558058', 'cui_str': 'Reflecting'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}]","[{'cui': 'C0015607', 'cui_str': 'Family practice'}, {'cui': 'C0031323', 'cui_str': 'Pharmacist'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0580105', 'cui_str': 'Change of medication'}, {'cui': 'C0010186', 'cui_str': 'Cost'}]",96.0,0.0952408,"There were no changes in patients' treatment burden or attitudes to deprescribing following medication review, and there were conflicting changes in patients' self-reported quality of life. ","[{'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Cardwell', 'Affiliation': 'HRB Centre for Primary Care Research, Department of General Practice, Royal College of Surgeons in Ireland, Dublin, Ireland.'}, {'ForeName': 'Susan M', 'Initials': 'SM', 'LastName': 'Smith', 'Affiliation': 'HRB Centre for Primary Care Research, Department of General Practice, Royal College of Surgeons in Ireland, Dublin, Ireland.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Clyne', 'Affiliation': 'HRB Centre for Primary Care Research, Department of General Practice, Royal College of Surgeons in Ireland, Dublin, Ireland.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'McCullagh', 'Affiliation': ""National Centre for Pharmacoeconomics, St James's University Teaching Hospital, Dublin, Ireland.""}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Wallace', 'Affiliation': 'HRB Centre for Primary Care Research, Department of General Practice, Royal College of Surgeons in Ireland, Dublin, Ireland.'}, {'ForeName': 'Ciara', 'Initials': 'C', 'LastName': 'Kirke', 'Affiliation': 'National Quality Improvement Team, Health Service Executive, Dublin, Ireland.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Fahey', 'Affiliation': 'HRB Centre for Primary Care Research, Department of General Practice, Royal College of Surgeons in Ireland, Dublin, Ireland.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Moriarty', 'Affiliation': 'HRB Centre for Primary Care Research, Department of General Practice, Royal College of Surgeons in Ireland, Dublin, Ireland frankmoriarty@rcsi.ie.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ open,['10.1136/bmjopen-2019-035087'] 2325,32595142,"Randomised, double-blinded, placebo-controlled trial to investigate the role of laparoscopic transversus abdominis plane block in gastric bypass surgery: a study protocol.","INTRODUCTION Evaluating the efficacy of a laparoscopically guided, surgical transversus abdominis plane (TAP) and rectus sheath (RS) block in reducing analgesic consumption while improving functional outcomes in patients undergoing laparoscopic bariatric surgery. METHODS 150 patients Living with obesity undergoing elective laparoscopic Roux-En-Y gastric bypass for obesity will be recruited to this double-blinded, placebo-controlled randomised controlled trial from a Bariatric Centre of Excellence over a period of 6 months. Patients will be electronically randomised on a 1:1 basis to either an intervention or placebo group. Those on the intervention arm will receive a total of 60 mL 0.25% ropivacaine, divided into four injections: two for TAP and two for RS block under laparoscopic visualisation. The placebo arm will receive normal saline in the same manner. A standardised surgical and anaesthetic protocol will be followed, with care in adherence to the Enhanced Recovery after Bariatric Surgery guidelines. ANALYSIS Demographic information and relevant medical history will be collected from the 150 patients enrolled in the study. Our primary efficacy endpoint is cumulative postoperative narcotic use. Secondary outcomes are peak expiratory flow, postoperative pain score and the 6 min walk test. Quality of recovery (QoR) will be assessed using a validated questionnaire (QoR-40). Statistical analysis will be conducted to assess differences within and between the two groups. The repeated measures will be analysed by a mixed modelling approach and results reported through publication. ETHICS AND DISSEMINATION Ethics approval was obtained (20170749-01H) through our institutional research ethics board (Ottawa Health Science Network Research Ethics Board) and the study results, regardless of the outcome, will be reported in a manuscript submitted for a medical/surgical journal. TRIAL REGISTRATION NUMBER Pre-results NCT03367728.",2020,"INTRODUCTION Evaluating the efficacy of a laparoscopically guided, surgical transversus abdominis plane (TAP) and rectus sheath (RS) block in reducing analgesic consumption while improving functional outcomes in patients undergoing laparoscopic bariatric surgery. ","['150 patients enrolled in the study', 'patients undergoing laparoscopic bariatric surgery', '150 patients Living with obesity undergoing elective laparoscopic Roux-En-Y gastric bypass for obesity', 'gastric bypass surgery']","['normal saline', 'ropivacaine', 'TAP and two for RS block under laparoscopic visualisation', 'laparoscopically guided, surgical transversus abdominis plane (TAP) and rectus sheath (RS) block', 'laparoscopic transversus abdominis plane block', 'placebo']","['Quality of recovery (QoR', 'cumulative postoperative narcotic use', 'peak expiratory flow, postoperative pain score and the 6\u2009min walk test']","[{'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C1456587', 'cui_str': 'Metabolic surgery'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0399839', 'cui_str': 'Bypass gastrojejunostomy'}]","[{'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0224378', 'cui_str': 'Structure of transversus abdominis muscle'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0027415', 'cui_str': 'Narcotic'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}]",150.0,0.709073,"INTRODUCTION Evaluating the efficacy of a laparoscopically guided, surgical transversus abdominis plane (TAP) and rectus sheath (RS) block in reducing analgesic consumption while improving functional outcomes in patients undergoing laparoscopic bariatric surgery. ","[{'ForeName': 'Amer', 'Initials': 'A', 'LastName': 'Jarrar', 'Affiliation': 'Department of Surgery, The Ottawa Hospital, Ottawa, Ontario, Canada ajarrar.md@gmail.com.'}, {'ForeName': 'Adele', 'Initials': 'A', 'LastName': 'Budiansky', 'Affiliation': 'Department of Anesthesia, The Ottawa Hospital, Ottawa, Ontario, Canada.'}, {'ForeName': 'Naveen', 'Initials': 'N', 'LastName': 'Eipe', 'Affiliation': 'Department of Anesthesia, The Ottawa Hospital, Ottawa, Ontario, Canada.'}, {'ForeName': 'Caolan', 'Initials': 'C', 'LastName': 'Walsh', 'Affiliation': 'Department of Surgery, The Ottawa Hospital, Ottawa, Ontario, Canada.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Kolozsvari', 'Affiliation': 'Department of Surgery, The Ottawa Hospital, Ottawa, Ontario, Canada.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Neville', 'Affiliation': 'Department of Surgery, The Ottawa Hospital, Ottawa, Ontario, Canada.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Mamazza', 'Affiliation': 'Department of Surgery, The Ottawa Hospital, Ottawa, Ontario, Canada.'}]",BMJ open,['10.1136/bmjopen-2018-025818'] 2326,32595244,"SAFETY AND EFFECTS OF CRATAEGUS EXTRACT WS 1442 AND NORDIC WALKING ON LIPID PROFILE AND ENDOTHELIAL FUNCTION: A RANDOMIZED, PARTIALLY BLINDED PILOT STUDY IN OVERWEIGHT VOLUNTEERS.","Overweight and physical inactivity adversely affect endothelial function and are risk factors for atherosclerosis and cardiovascular disease. Both Crataegus extract WS 1442 and physical exercise exert beneficial effects on endothelial function. We investigated whether WS 1442 and Nordic walking (NW) had comparable effects on endothelial function and lipid profile in overweight subjects. In this partially blinded pilot study, overweight, otherwise healthy volunteers aged 45-75 years were randomized into four groups as follows: WS 1442 2x450 mg/day (WS-standard), WS 1442 2x900 mg/day (WS-double), exercise 2x30 minutes/week (NW-low), and exercise 4x45 minutes/week (NW-high) for 12 weeks. Safety was assessed based on adverse events. Endothelial function testing (EndoPAT ® ), assessment of endothelial progenitor cells, lipid profiles, and treadmill testing were performed. Sixty subjects participated in the study. At baseline, subjects in WS-standard/-double groups had higher lipid levels and greater impairment of endothelial function. Subjects with impaired endothelial function showed improvement regardless of the type of intervention. Subjects in WS-standard and WS-double groups showed a trend towards modest decrease in triglycerides and modest increase in HDL-cholesterol; most changes were within the normal limits. In NW-low/-high groups, values also remained within the normal range. Exercise capacity improved in both NW groups. WS-double showed no additional benefits over WS-standard. All adverse events were unrelated or improbably related to treatment. In conclusion, WS 1442 and exercise training were safe and showed beneficial effects on endothelial function and lipid profile in overweight but otherwise healthy volunteers; exercise capacity improved only by Nordic walking.",2019,Exercise capacity improved in both NW groups.,"['overweight subjects', 'overweight, otherwise healthy volunteers aged 45-75 years', 'overweight but otherwise healthy volunteers', 'Sixty subjects participated in the study']","['WS 1442 and Nordic walking (NW', 'WS 1442 and exercise training', 'physical exercise']","['endothelial function', 'triglycerides', 'Endothelial function testing (EndoPAT ® ), assessment of endothelial progenitor cells, lipid profiles, and treadmill testing', 'Exercise capacity', 'exercise capacity', 'HDL-cholesterol', 'endothelial function and lipid profile', 'lipid levels']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0964758', 'cui_str': 'WS 1442'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C3850017', 'cui_str': 'Circulating Endothelial Progenitor Cells'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018667', 'cui_str': 'Cholesterol in high density lipoprotein subfraction 2'}, {'cui': 'C0428460', 'cui_str': 'Lipid level - finding'}]",60.0,0.0554614,Exercise capacity improved in both NW groups.,"[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Niederseer', 'Affiliation': '1University Institute of Sports Medicine, Prevention and Rehabilitation, Paracelsus Medical University, Institute of Sports Medicine of the State of Salzburg, Salzburg, Austria; 2Clinical Research Department, Dr. Willmar Schwabe GmbH & Co. KG, Karlsruhe, Germany.'}, {'ForeName': 'Eveline', 'Initials': 'E', 'LastName': 'Ledl-Kurkowski', 'Affiliation': '1University Institute of Sports Medicine, Prevention and Rehabilitation, Paracelsus Medical University, Institute of Sports Medicine of the State of Salzburg, Salzburg, Austria; 2Clinical Research Department, Dr. Willmar Schwabe GmbH & Co. KG, Karlsruhe, Germany.'}, {'ForeName': 'Klara', 'Initials': 'K', 'LastName': 'Kvita', 'Affiliation': '1University Institute of Sports Medicine, Prevention and Rehabilitation, Paracelsus Medical University, Institute of Sports Medicine of the State of Salzburg, Salzburg, Austria; 2Clinical Research Department, Dr. Willmar Schwabe GmbH & Co. KG, Karlsruhe, Germany.'}, {'ForeName': 'Petra', 'Initials': 'P', 'LastName': 'Funk', 'Affiliation': '1University Institute of Sports Medicine, Prevention and Rehabilitation, Paracelsus Medical University, Institute of Sports Medicine of the State of Salzburg, Salzburg, Austria; 2Clinical Research Department, Dr. Willmar Schwabe GmbH & Co. KG, Karlsruhe, Germany.'}, {'ForeName': 'Josef', 'Initials': 'J', 'LastName': 'Niebauer', 'Affiliation': '1University Institute of Sports Medicine, Prevention and Rehabilitation, Paracelsus Medical University, Institute of Sports Medicine of the State of Salzburg, Salzburg, Austria; 2Clinical Research Department, Dr. Willmar Schwabe GmbH & Co. KG, Karlsruhe, Germany.'}]",Acta clinica Croatica,['10.20471/acc.2019.58.04.06'] 2327,32595296,Effects of a Class-Based School Violence Prevention Program for Elementary School Students.,"Objectives This study was conducted to investigate the effectiveness of a class-based school violence prevention program for elementary school student. Methods 29 students were assigned to the school violence prevention program of 8 sessions, 28 students have been assigned to the control group. We assessed participants at baseline and post-intervention, through their self-report questionnaires such as Children's Depression Inventory (CDI), Strengths and Difficulties Questionnaire and school violence experience, awareness about school violence, and coping ability to school violence. We compared the baseline and post-intervention result of each group and compared the posttest scores between the intervention group and the control group. Results Comparing the intervention group and the control group, the post-intervention CDI total score and the awareness about school violence showed significant improvement in the intervention group. When compared according to gender, male students' perception of school violence was improved, and female students showed significant differences in CDI scores. Conclusion The CDI total scores and the perception of school violence were improved in the intervention group compared to the control group. And there are differential pattern of intervention effects according to gender. These findings have important implications to develop effective violence prevention programs.",2018,"Comparing the intervention group and the control group, the post-intervention CDI total score and the awareness about school violence showed significant improvement in the intervention group.","['elementary school student', '28 students have been assigned to the control group', 'Elementary School Students', '29 students']","['class-based school violence prevention program', 'school violence prevention program of 8 sessions', 'Class-Based School Violence Prevention Program']","['CDI total scores and the perception of school violence', 'CDI scores', ""Children's Depression Inventory (CDI), Strengths and Difficulties Questionnaire and school violence experience, awareness about school violence, and coping ability to school violence"", 'school violence']","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0150215', 'cui_str': 'Violence prevention'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0042693', 'cui_str': 'Violence'}, {'cui': 'C3472494', 'cui_str': 'Strengths and difficulties questionnaire'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0085732', 'cui_str': 'Ability'}]",29.0,0.0147846,"Comparing the intervention group and the control group, the post-intervention CDI total score and the awareness about school violence showed significant improvement in the intervention group.","[{'ForeName': 'Soo Youn', 'Initials': 'SY', 'LastName': 'Lim', 'Affiliation': 'Department of Psychiatry, Jeju National University Hospital, Jeju, Korea.'}, {'ForeName': 'Na Ri', 'Initials': 'NR', 'LastName': 'Kang', 'Affiliation': 'Department of Psychiatry, Jeju National University Hospital, Jeju, Korea.'}, {'ForeName': 'Young Sook', 'Initials': 'YS', 'LastName': 'Kwack', 'Affiliation': 'Department of Psychiatry, Jeju National University School of Medicine, Jeju, Korea.'}]",Soa--ch'ongsonyon chongsin uihak = Journal of child & adolescent psychiatry,['10.5765/jkacap.2018.29.2.54'] 2328,32595318,"Cognitive Function, Emotional and Behavioral Problems, and Temperament of Premature Children.","Objectives We aimed to compare preterm, neurodevelopmentally disordered and healthy full-term children. Methods We enrolled 47 children who were born preterm, 40 neurodevelopmentally disordered children, and 80 healthy children as control participants, in order to assess the cognitive functioning and the risk of behavioral problems at the age of 5. Children were assessed using the Korean Wechsler Preschool and Primary Scale of Intelligence-4th edition (K-WPPSI-IV), the Child Behavior Checklist (CBCL), and the Temperament and Character Inventory (TCI). Results The mean K-WPPSI-IV score of the preterm group was 87.19±17.36, which was significantly higher than that of the neurodevelopmental disorder group (69.98±28.63; p<0.001) but lower than that of the control group (107.74±14.21; p<0.001). The cumulative CBCL scores of the preterm children were not significantly different from those of the control group. Additionally, the TCI scores for reward dependence of the preterm children were higher than those of the control group. Conclusion The cognitive performance of preterm infants was lower than that of healthy full-term infants at the age of 5, and there was an association between slower growth and decreased cognitive ability.",2019,The cumulative CBCL scores of the preterm children were not significantly different from those of the control group.,"['47 children who were born preterm, 40 neurodevelopmentally disordered children, and 80 healthy children as control participants, in order to assess the cognitive functioning and the risk of behavioral problems at the age of 5', 'preterm, neurodevelopmentally disordered and healthy full-term children']",[],"['cognitive performance', 'mean K-WPPSI-IV score', 'Cognitive Function, Emotional and Behavioral Problems, and Temperament of Premature Children', 'cognitive ability', 'TCI scores for reward dependence', 'Korean Wechsler Preschool and Primary Scale of Intelligence-4th edition (K-WPPSI-IV), the Child Behavior Checklist (CBCL), and the Temperament and Character Inventory (TCI', 'cumulative CBCL scores']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0686744', 'cui_str': 'Well child'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4284072', 'cui_str': 'Order document'}, {'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0233514', 'cui_str': 'Abnormal behavior'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}]",[],"[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C2828074', 'cui_str': 'WPPSI'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0233514', 'cui_str': 'Abnormal behavior'}, {'cui': 'C0039474', 'cui_str': 'Temperament'}, {'cui': 'C0151526', 'cui_str': 'Premature pregnancy delivered'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}, {'cui': 'C0007952', 'cui_str': 'Character'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0035397', 'cui_str': 'Rewards'}, {'cui': 'C0011546', 'cui_str': 'Dependency, Psychology'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C0205438', 'cui_str': 'Fourth'}, {'cui': 'C0441792', 'cui_str': 'Editions'}, {'cui': 'C0008065', 'cui_str': 'Behavior, Child'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}]",47.0,0.0627888,The cumulative CBCL scores of the preterm children were not significantly different from those of the control group.,"[{'ForeName': 'Dong-Hyun', 'Initials': 'DH', 'LastName': 'Ahn', 'Affiliation': 'Department of Psychiatry, Hanyang University Hospital, Seoul, Korea.'}, {'ForeName': 'Aran', 'Initials': 'A', 'LastName': 'Min', 'Affiliation': 'Department of Psychiatry, Hanyang University Hospital, Seoul, Korea.'}, {'ForeName': 'Kangryul', 'Initials': 'K', 'LastName': 'Kim', 'Affiliation': 'Department of Psychiatry, Hanyang University Hospital, Seoul, Korea.'}, {'ForeName': 'Kyung-Ah', 'Initials': 'KA', 'LastName': 'Kim', 'Affiliation': 'Department of Psychiatry, Hanyang University Hospital, Seoul, Korea.'}, {'ForeName': 'Mi-Young', 'Initials': 'MY', 'LastName': 'Oh', 'Affiliation': 'Department of Psychiatry, Hanyang University Hospital, Seoul, Korea.'}, {'ForeName': 'Hyun Ju', 'Initials': 'HJ', 'LastName': 'Lee', 'Affiliation': 'Department of Pediatrics, Hanyang University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Hyun-Kyung', 'Initials': 'HK', 'LastName': 'Park', 'Affiliation': 'Department of Pediatrics, Hanyang University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Hyewon', 'Initials': 'H', 'LastName': 'Park', 'Affiliation': 'Department of Child & Family Welfare, University of Ulsan, Ulsan, Korea.'}]",Soa--ch'ongsonyon chongsin uihak = Journal of child & adolescent psychiatry,['10.5765/jkacap.180024'] 2329,32595334,Review of Early Intervention for Children with Autism Spectrum Disorder: Focused on Randomized Controlled Trials.,"Early identification and intervention for autism spectrum disorder (ASD) were reported to be important for outcomes or clinical courses. However, there have been a few robust evidences for effectiveness of early intervention until now. This review aims to identify the effectiveness of early intervention by investigating the randomized controlled trial (RCT) of early intervention for autism. There are some RCT studies using behavioral program. Although there are some significant findings, the outcome measurements and small sample size are the limitations. Further studies are needed.",2019,Early identification and intervention for autism spectrum disorder (ASD) were reported to be important for outcomes or clinical courses.,"['Spectrum Disorder', 'autism spectrum disorder (ASD', 'Children with Autism', 'autism']",[],[],"[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004352', 'cui_str': 'Autistic disorder'}]",[],[],,0.130374,Early identification and intervention for autism spectrum disorder (ASD) were reported to be important for outcomes or clinical courses.,"[{'ForeName': 'Young-Hui', 'Initials': 'YH', 'LastName': 'Yang', 'Affiliation': 'Department of Child and Adolescent Psychiatry, National Center for Mental Health, Seoul, Korea.'}]",Soa--ch'ongsonyon chongsin uihak = Journal of child & adolescent psychiatry,['10.5765/jkacap.180035'] 2330,32599496,Randomized controlled three-arm study of NADA acupuncture for alcohol addiction.,"INTRODUCTION Alcohol addiction compromises cardiovascular health, possibly due to impaired control of the heart and vasculature by the autonomic nervous system. We aimed to assess the effects of National Acupuncture Detoxification Association (NADA) acupuncture on cardiovascular autonomic functions, psychiatric comorbidities and abstinence in patients addicted to alcohol. MATERIAL AND METHODS A randomized sham controlled three-arm study was undertaken in 72 patients (nine females, aged 43.7 ± 9.2 years, mean ± SD) undergoing in-patient rehabilitation for alcohol addiction. Patients were randomly allocated (1:1:1) to receive twenty 30-minute NADA or sham acupuncture sessions within six weeks or no intervention. They were evaluated for craving, depression, anxiety and autonomic control of the heart (heart rate variability, HRV), vasculature (laser Doppler flowmetry) and sweat glands (sympathetic skin response). Testing was performed at baseline, immediately post intervention (sham intervention or control period, respectively) and another four weeks later. Abstinence was assessed one year after study completion. RESULTS Patients in the NADA arm displayed increased HRV immediately post-intervention compared to baseline (SDNN: 72.8 ms ± 34.2 ms vs. 57.9 ms ± 31.2 ms, p = 0.001). This increase was sustained four weeks later (66.2 ms ± 32.4 ms, p = 0.015). HRV remained unaltered following sham or no acupuncture (p = n.s.). Autonomic function of vasculature and sweat glands, psychiatric comorbidities and one-year abstinence did not differ between study arms. CONCLUSIONS NADA acupuncture may improve autonomic cardiac function. However, this improvement appears not to translate into alleviation of psychiatric comorbidities or sustained abstinence.",2020,"This increase was sustained four weeks later (66.2 ms ± 32.4 ms, p = 0.015).","['patients addicted to alcohol', '72 patients (nine females, aged 43.7\xa0±\xa09.2\xa0years, mean\xa0±\xa0SD) undergoing in-patient rehabilitation for alcohol addiction', '34.2']","['NADA or sham acupuncture sessions within six weeks or no intervention', 'National Acupuncture Detoxification Association (NADA) acupuncture', 'sham or no acupuncture', 'NADA acupuncture']","['HRV', 'Autonomic function of vasculature and sweat glands, psychiatric comorbidities and one-year abstinence', 'craving, depression, anxiety and autonomic control of the heart (heart rate variability, HRV), vasculature (laser Doppler flowmetry) and sweat glands (sympathetic skin response', 'autonomic cardiac function', 'cardiovascular autonomic functions, psychiatric comorbidities and abstinence']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001973', 'cui_str': 'Alcohol dependence'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C5191219', 'cui_str': '9.2'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C5191359', 'cui_str': '34.2'}]","[{'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0025516', 'cui_str': 'Detoxication, Drug, Metabolic'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0010343', 'cui_str': 'Croatia'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0005839', 'cui_str': 'blood supply'}, {'cui': 'C0038989', 'cui_str': 'Sweat gland structure'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C4082117', 'cui_str': 'One year'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0162520', 'cui_str': 'Laser doppler flowmetry'}, {'cui': 'C0312646', 'cui_str': 'Finding related to response to skin test'}, {'cui': 'C0232164', 'cui_str': 'Cardiac function'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}]",72.0,0.09429,"This increase was sustained four weeks later (66.2 ms ± 32.4 ms, p = 0.015).","[{'ForeName': 'Florian', 'Initials': 'F', 'LastName': 'Krause', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, University Hospital Carl Gustav Carus, Technische Universität Dresden, Dresden, Germany.'}, {'ForeName': 'Ana Isabel', 'Initials': 'AI', 'LastName': 'Penzlin', 'Affiliation': 'Center for Autonomic and Peripheral Nerve Disorders, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, United States.'}, {'ForeName': 'Gerhard', 'Initials': 'G', 'LastName': 'Ritschel', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, University Hospital Carl Gustav Carus, Technische Universität Dresden, Dresden, Germany.'}, {'ForeName': 'Kristian', 'Initials': 'K', 'LastName': 'Barlinn', 'Affiliation': 'Department of Neurology, University Hospital Carl Gustav Carus, Technische Universität Dresden, Dresden, Germany.'}, {'ForeName': 'Heinz', 'Initials': 'H', 'LastName': 'Reichmann', 'Affiliation': 'Department of Neurology, University Hospital Carl Gustav Carus, Technische Universität Dresden, Dresden, Germany.'}, {'ForeName': 'Kerstin', 'Initials': 'K', 'LastName': 'Weidner', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, University Hospital Carl Gustav Carus, Technische Universität Dresden, Dresden, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Siepmann', 'Affiliation': 'Department of Psychosomatic Medicine and Psychotherapy, University Hospital Carl Gustav Carus, Technische Universität Dresden, Dresden, Germany.'}, {'ForeName': 'Timo', 'Initials': 'T', 'LastName': 'Siepmann', 'Affiliation': 'Department of Neurology, University Hospital Carl Gustav Carus, Technische Universität Dresden, Dresden, Germany. Electronic address: timo.siepmann@ukdd.de.'}]",Addictive behaviors,['10.1016/j.addbeh.2020.106488'] 2331,32599497,A randomized comparison of estimated radiation exposure between Low and conventional dose protocol during invasive coronary angiography (ERICA trial): Pilot study.,"PURPOSE Radiation exposure during coronary angiography is potentially harmful to patients and operators. However, there are limited data on the effects of a low-dose radiation angiography. We evaluated the feasibility and effectiveness of a reduced radiation dose protocol during invasive coronary angiography. METHODS One hundred three consecutive patients who underwent coronary angiography were enrolled and randomized to low- or conventional dose protocols (LDP versus CDP). The LDP consists of 10 frames per second during fluoroscopy and half the radiation dose of CDP during cineangiography. Image quality was assessed using a Likert rating scale by an independent radiologist. The radiation dose was estimated with dose-area product (DAP) and air-kerma (AK). RESULTS Body weight and waist circumference are well correlated with the level of DAP and AK. Exposure time and total images and frame counts in cineangiography were similar in both groups. There was a marked reduction of the estimated radiation dose (DAP and AK) in the LDP group compared to the CDP group without significant compromise in image quality (total DAP: LDP 1980.1 ± 1163.7 vs. CDP 3434.2 ± 2188.1 μGym 2 p = 0.001; total AK: 279.6 ± 159.3 vs. 493.8 ± 280.6 mGy, p < 0.001). CONCLUSION The LDP reduced the total estimated radiation dose compared to the CDP without a significant loss of diagnostic information. A LDP may be a viable strategy to protect patients and medical staff from the hazards of radiation in the cardiac catheterization laboratory.",2020,There was a marked reduction of the estimated radiation dose (DAP and AK) in the LDP group compared to the CDP group without significant compromise in image quality (total DAP:,['One hundred three consecutive patients who underwent'],"['estimated radiation exposure between Low and conventional dose protocol', 'low- or conventional dose protocols (LDP versus CDP', 'coronary angiography', 'CDP']","['Body weight and waist circumference', 'feasibility and effectiveness', 'Image quality', 'estimated radiation dose (DAP and AK', 'image quality (total DAP', 'Exposure time and total images and frame counts in cineangiography', 'Likert rating scale']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0015333', 'cui_str': 'Exposure to radiation'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0008188', 'cui_str': 'Chlordiazepoxide'}, {'cui': 'C0085532', 'cui_str': 'Coronary angiography'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0045587', 'cui_str': '2,6-diaminopurine'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0080089', 'cui_str': 'Reading Frames'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0008795', 'cui_str': 'Cineangiography'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",103.0,0.0489571,There was a marked reduction of the estimated radiation dose (DAP and AK) in the LDP group compared to the CDP group without significant compromise in image quality (total DAP:,"[{'ForeName': 'Sang Min', 'Initials': 'SM', 'LastName': 'Park', 'Affiliation': 'Division of Cardiology, Cardiovascular Center, Chuncheon Sacred Heart Hospital, Hallym University College of Medicine, Chuncheon, Republic of Korea. Electronic address: samipark@hanmail.net.'}, {'ForeName': 'Heung Cheol', 'Initials': 'HC', 'LastName': 'Kim', 'Affiliation': 'Department of Radiology, Chuncheon Sacred Heart Hospital, Hallym University College of Medicine, Chuncheon, Republic of Korea.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Lee', 'Affiliation': 'Division of Cardiology, UCLA Medical Center, Los Angeles, CA, USA.'}, {'ForeName': 'Christopher Y', 'Initials': 'CY', 'LastName': 'Kim', 'Affiliation': 'Utah Cardiology, Farmington, Utah, USA.'}]",European journal of radiology,['10.1016/j.ejrad.2020.109120'] 2332,32599641,Concurrent Exercise Interventions in Breast Cancer Survivors with Cancer-related Fatigue.,"This study compared the effects of two supervised concurrent training interventions in breast cancer survivors with cancer-related fatigue at baseline. Twenty-three female breast cancer survivors (50±8 years) were randomized to a high- (n=13) or a moderate-intensity (n=10) training program. Both interventions lasted 16 weeks and included the same resistance exercises, but the aerobic component was supervised and more intense in the former (i.e., rating of perceived exertion of 7-8 vs. 6 on a 1-10 scale for the high and moderate-intensity intervention, respectively). The primary endpoint was fatigue perception. Endpoints were assessed at baseline and after 16 weeks. The p-value for statistical significance was set at 0.004 after Bonferroni correction for multiple comparisons. The high-intensity training program increased lower-limb muscle strength significantly (p=0.002) and tended to improve fatigue perception (p=0.006), waist circumference (p=0.013), neutrophil-to-lymphocyte ratio (p=0.028) and some quality of life items (p=0.011). Although the moderate-intensity training program did not provide such benefits in general (i.e., higher p-values for pre vs post-intervention comparisons), no significant differences were found between interventions (all p>0.004). Further research is needed to elucidate if the benefits provided by high-intensity concurrent training are superior to those elicited by moderate-intensity training in breast cancer survivors.",2020,"The high-intensity training program increased lower-limb muscle strength significantly (p=0.002) and tended to improve fatigue perception (p=0.006), waist circumference (p=0.013), neutrophil-to-lymphocyte ratio (p=0.028) and some quality of life items (p=0.011).","['breast cancer survivors with cancer-related fatigue at baseline', 'breast cancer survivors', 'Breast Cancer Survivors with Cancer-related Fatigue', 'Twenty-three female breast cancer survivors (50±8 years']","['supervised concurrent training interventions', 'Concurrent Exercise Interventions', 'high- (n=13) or a moderate-intensity (n=10) training program']","['waist circumference', 'neutrophil-to-lymphocyte ratio', 'quality of life items', 'fatigue perception', 'lower-limb muscle strength']","[{'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C4274302', 'cui_str': 'Cancer-related fatigue'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0450348', 'cui_str': '23'}, {'cui': 'C0235653', 'cui_str': 'Malignant neoplasm of female breast'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}]","[{'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear leukocyte'}, {'cui': 'C0024264', 'cui_str': 'Lymphocyte'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}]",23.0,0.0278464,"The high-intensity training program increased lower-limb muscle strength significantly (p=0.002) and tended to improve fatigue perception (p=0.006), waist circumference (p=0.013), neutrophil-to-lymphocyte ratio (p=0.028) and some quality of life items (p=0.011).","[{'ForeName': 'Itiziar', 'Initials': 'I', 'LastName': 'Pagola', 'Affiliation': 'Faculty of Sport Sciences, Universidad Europea de Madrid, Spain.'}, {'ForeName': 'Javier S', 'Initials': 'JS', 'LastName': 'Morales', 'Affiliation': 'Faculty of Sport Sciences, Universidad Europea de Madrid, Spain.'}, {'ForeName': 'Lidia B', 'Initials': 'LB', 'LastName': 'Alejo', 'Affiliation': 'Faculty of Sport Sciences, Universidad Europea de Madrid, Spain.'}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Barcelo', 'Affiliation': 'Faculty of Sport Sciences, Universidad Europea de Madrid, Spain.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Montil', 'Affiliation': 'Faculty of Sport Sciences, Universidad Europea de Madrid, Spain.'}, {'ForeName': 'Jesús', 'Initials': 'J', 'LastName': 'Oliván', 'Affiliation': 'School of Physical Activity and Sport Sciences-INEF, Universidad Politecnica de Madrid, Madrid, Spain.'}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Álvarez-Bustos', 'Affiliation': 'Department of Medical Oncology, Puerta de Hierro University Hospital of Majadahonda, Majadahonda, Spain.'}, {'ForeName': 'Blanca', 'Initials': 'B', 'LastName': 'Cantos', 'Affiliation': 'Department of Medical Oncology, Puerta de Hierro University Hospital of Majadahonda, Majadahonda, Spain.'}, {'ForeName': 'Constanza', 'Initials': 'C', 'LastName': 'Maximiano', 'Affiliation': 'Department of Medical Oncology, Puerta de Hierro University Hospital of Majadahonda, Majadahonda, Spain.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Hidalgo', 'Affiliation': 'Faculty of Sport Sciences, Universidad Europea de Madrid, Spain.'}, {'ForeName': 'Pedro L', 'Initials': 'PL', 'LastName': 'Valenzuela', 'Affiliation': 'Physiology Unit, Systems Biology Department, University of Alcala de Henares, Madrid, Spain.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Fiuza-Luces', 'Affiliation': '12th of October Hospital Research Institute, Physiology, Madrid, Spain.'}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Lucia', 'Affiliation': 'Faculty of Sport Sciences, Universidad Europea de Madrid, Spain.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Ruiz-Casado', 'Affiliation': 'Department of Medical Oncology, Puerta de Hierro University Hospital of Majadahonda, Majadahonda, Spain.'}]",International journal of sports medicine,['10.1055/a-1147-1513'] 2333,32599644,The Effects of Performing Mental Exertion during Cycling Exercise on Fatigue Indices.,"This study investigated the effect of performing prolonged mental exertion during submaximal cycling exercise on exercise tolerance and fatigue. Participants performed 5 experimental sessions. Session 1: determination of cycling peak power output. Sessions 2 and 3: cycling to exhaustion at 65% peak power output with mental exertion or watching a movie. Sessions 4 and 5: cycling for 45 min at 65% peak power output with mental exertion or while watching a movie. During sessions 2-5, rate of perceived exertion and heart rate were recorded while cycling and cortisol and prolactin concentrations, psychomotor vigilance task performance, and maximal voluntary contraction were measured pre-and post-sessions. During sessions 2 and 3, time to exhaustion was reduced ( p <0.01) and rate of perceived exertion was increased ( p <0.01) in session 2 compared to 3. Cortisol, prolactin and heart rate increased and psychomotor vigilance task and maximal voluntary contraction decreased from pre-to post-sessions with no difference between sessions. Cortisol, prolactin and rate of perceived exertion were higher ( p <0.03) in session 4 than 5. Heart rate increased and maximal voluntary contraction decreased from pre-to post-sessions with no difference between sessions. Prolonged mental exertion during cycling exercise reduces exercise tolerance, which appears to be mediated psychologically rather than physiologically.",2020,"Cortisol, prolactin and rate of perceived exertion were higher ( p <0.03) in session 4 than 5.",[],"['Performing Mental Exertion during Cycling Exercise', 'Sessions 2 and 3: cycling to exhaustion at 65% peak power output with mental exertion or watching a movie', 'Sessions 4 and 5: cycling for 45 min at 65% peak power output with mental exertion or while watching a movie', 'performing prolonged mental exertion during submaximal cycling exercise']","['Cortisol, prolactin and heart rate increased and psychomotor vigilance task and maximal voluntary contraction', 'rate of perceived exertion and heart rate', 'Heart rate increased and maximal voluntary contraction', 'cycling and cortisol and prolactin concentrations, psychomotor vigilance task performance, and maximal voluntary contraction', 'time to exhaustion', 'exercise tolerance and fatigue', 'rate of perceived exertion', 'Cortisol, prolactin and rate of perceived exertion', 'Fatigue Indices']",[],"[{'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0392674', 'cui_str': 'Exhaustion'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0445194', 'cui_str': 'Power output'}, {'cui': 'C0681495', 'cui_str': 'Movies'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}]","[{'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C0033371', 'cui_str': 'Prolactin'}, {'cui': 'C0039231', 'cui_str': 'Tachycardia'}, {'cui': 'C0043012', 'cui_str': 'Wakefulness'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0039333', 'cui_str': 'Task Performance'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0392674', 'cui_str': 'Exhaustion'}, {'cui': 'C0162521', 'cui_str': 'Exercise tolerance'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",,0.0531489,"Cortisol, prolactin and rate of perceived exertion were higher ( p <0.03) in session 4 than 5.","[{'ForeName': 'Hamidreza', 'Initials': 'H', 'LastName': 'Barzegarpoor', 'Affiliation': 'Sport Sciences and Health, Shahid Beheshti University, Tehran, Iran (the Islamic Republic of).'}, {'ForeName': 'Hamid', 'Initials': 'H', 'LastName': 'Amoozi', 'Affiliation': 'Sport Sciences and Health, Shahid Beheshti University, Tehran, Iran (the Islamic Republic of).'}, {'ForeName': 'Hamid', 'Initials': 'H', 'LastName': 'Rajabi', 'Affiliation': 'Sport sciences, Kharazmi University, Tehran, Iran (the Islamic Republic of).'}, {'ForeName': 'Duane', 'Initials': 'D', 'LastName': 'Button', 'Affiliation': ""School of Human Kinetics and Recreation, Memorial University of Newfoundland, St. John's, Canada.""}, {'ForeName': 'Rana', 'Initials': 'R', 'LastName': 'Fayazmilani', 'Affiliation': 'Sport Sciences and Health, Shahid Beheshti University, Tehran, Iran (the Islamic Republic of).'}]",International journal of sports medicine,['10.1055/a-1179-8326'] 2334,32599815,"Prognostic Impact of Active Mechanical Circulatory Support in Cardiogenic Shock Complicating Acute Myocardial Infarction, Results from the Culprit-Shock Trial.","OBJECTIVES To analyze the use and prognostic impact of active mechanical circulatory support (MCS) devices in a large prospective contemporary cohort of patients with cardiogenic shock (CS) complicating acute myocardial infarction (AMI). BACKGROUND Although increasingly used in clinical practice, data on the efficacy and safety of active MCS devices in patients with CS complicating AMI are limited. METHODS This is a predefined subanalysis of the CULPRIT-SHOCK randomized trial and prospective registry. Patients with CS, AMI and multivessel coronary artery disease were categorized in two groups: (1) use of at least one active MCS device vs. (2) no active MCS or use of intra-aortic balloon pump (IABP) only. The primary endpoint was a composite of all-cause death or renal replacement therapy at 30 days. RESULTS Two hundred of 1055 (19%) patients received at least one active MCS device ( n = 112 Impella ® ; n = 95 extracorporeal membrane oxygenation (ECMO); n = 6 other devices). The primary endpoint occurred significantly more often in patients treated with active MCS devices compared with those without active MCS devices (142 of 197, 72% vs. 374 of 827, 45%; p < 0.001). All-cause mortality and bleeding rates were significantly higher in the active MCS group (all p < 0.001). After multivariable adjustment, the use of active MCS was significantly associated with the primary endpoint (odds ratio (OR) 4.0, 95% confidence interval (CI) 2.7-5.9; p < 0.001). CONCLUSIONS In the CULPRIT-SHOCK trial, active MCS devices were used in approximately one fifth of patients. Patients treated with active MCS devices showed worse outcome at 30 days and 1 year.",2020,All-cause mortality and bleeding rates were significantly higher in the active MCS group (,"['patients with cardiogenic shock (CS) complicating acute myocardial infarction (AMI', 'Patients with CS, AMI and multivessel coronary artery disease', 'patients with CS complicating AMI', 'Cardiogenic Shock Complicating Acute Myocardial Infarction', 'Two hundred of 1055 (19%) patients received at least one active MCS device ( n = 112 Impella ® ; n = 95']","['active MCS devices', 'active mechanical circulatory support (MCS) devices', 'active MCS', 'active MCS device vs. (2) no active MCS or use of intra-aortic balloon pump (IABP', 'Active Mechanical Circulatory Support', 'extracorporeal membrane oxygenation (ECMO); n = 6 other devices']","['mortality and bleeding rates', 'composite of all-cause death or renal replacement therapy at 30 days']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036980', 'cui_str': 'Cardiogenic shock'}, {'cui': 'C0231242', 'cui_str': 'Complicated'}, {'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0005775', 'cui_str': 'Circulation, Blood'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C4319548', 'cui_str': '112'}]","[{'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0005775', 'cui_str': 'Circulation, Blood'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0021860', 'cui_str': 'Cardioassist by aortic balloon pump'}, {'cui': 'C0015357', 'cui_str': 'Extracorporeal membrane oxygenation'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0206074', 'cui_str': 'Renal replacement therapy'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",,0.380042,All-cause mortality and bleeding rates were significantly higher in the active MCS group (,"[{'ForeName': 'Hans-Josef', 'Initials': 'HJ', 'LastName': 'Feistritzer', 'Affiliation': 'Department of Internal Medicine/Cardiology, Heart Center Leipzig at University of Leipzig and Leipzig Heart Institute, 04289 Leipzig, Germany.'}, {'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Desch', 'Affiliation': 'Department of Internal Medicine/Cardiology, Heart Center Leipzig at University of Leipzig and Leipzig Heart Institute, 04289 Leipzig, Germany.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Freund', 'Affiliation': 'Department of Internal Medicine/Cardiology, Heart Center Leipzig at University of Leipzig and Leipzig Heart Institute, 04289 Leipzig, Germany.'}, {'ForeName': 'Janine', 'Initials': 'J', 'LastName': 'Poess', 'Affiliation': 'Department of Internal Medicine/Cardiology, Heart Center Leipzig at University of Leipzig and Leipzig Heart Institute, 04289 Leipzig, Germany.'}, {'ForeName': 'Uwe', 'Initials': 'U', 'LastName': 'Zeymer', 'Affiliation': 'Institut für Herzinfarktforschung GmbH, IHF, 67063 Ludwigshafen, Germany.'}, {'ForeName': 'Taoufik', 'Initials': 'T', 'LastName': 'Ouarrak', 'Affiliation': 'Institut für Herzinfarktforschung GmbH, IHF, 67063 Ludwigshafen, Germany.'}, {'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Schneider', 'Affiliation': 'Institut für Herzinfarktforschung GmbH, IHF, 67063 Ludwigshafen, Germany.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'de Waha-Thiele', 'Affiliation': 'Department of Cardiology, Angiology and Intensive Care Medicine, University Heart Center Lübeck, University Hospital Schleswig-Holstein, 23538 Lübeck, Germany.'}, {'ForeName': 'Georg', 'Initials': 'G', 'LastName': 'Fuernau', 'Affiliation': 'Department of Cardiology, Angiology and Intensive Care Medicine, University Heart Center Lübeck, University Hospital Schleswig-Holstein, 23538 Lübeck, Germany.'}, {'ForeName': 'Ingo', 'Initials': 'I', 'LastName': 'Eitel', 'Affiliation': 'Department of Cardiology, Angiology and Intensive Care Medicine, University Heart Center Lübeck, University Hospital Schleswig-Holstein, 23538 Lübeck, Germany.'}, {'ForeName': 'Marko', 'Initials': 'M', 'LastName': 'Noc', 'Affiliation': 'University Medical Center Ljubljana, 1000 Ljubljana, Slovenia.'}, {'ForeName': 'Janina', 'Initials': 'J', 'LastName': 'Stepinska', 'Affiliation': 'Institute of Cardiology, 04-628 Warsaw, Poland.'}, {'ForeName': 'Kurt', 'Initials': 'K', 'LastName': 'Huber', 'Affiliation': 'Department of Cardiology, Wilhelminenspital and Sigmund Freud University, Medical School, 1160 Vienna, Austria.'}, {'ForeName': 'Holger', 'Initials': 'H', 'LastName': 'Thiele', 'Affiliation': 'Department of Internal Medicine/Cardiology, Heart Center Leipzig at University of Leipzig and Leipzig Heart Institute, 04289 Leipzig, Germany.'}]",Journal of clinical medicine,['10.3390/jcm9061976'] 2335,32595783,Effect of Mindfulness-Based Relapse Prevention on Impulsivity Trajectories Among Young Adults in Residential Substance Use Disorder Treatment.,"Objectives Impulsivity has been identified as an important construct in predicting the initiation and maintenance of substance use among at-risk populations. Interventions emphasizing mindfulness strategies appear particularly promising in reducing substance use and marking change in various aspects of impulsivity. Methods The current study used a rolling group mindfulness-based relapse prevention (MBRP) intervention for young adults in residential substance use disorder treatment. We examined change in impulsivity facets measured by the S-UPPS for youth randomly assigned to MBRP ( n = 45) versus those assigned to treatment as usual plus 12 step/self-help ( n = 34). We also examined how change in impulsivity mediated changes in substance use post-treatment. Results In general, results indicated that MBRP is effective at reducing facets of trait impulsivity in treatment-seeking individuals with SUDs. Only positive and negative urgency mediated the relation between treatment assignment and substance use. Conclusions MBRP is a viable and useful intervention for young adults in residential treatment for substance use disorders and can aid in marked change in facets of impulsivity. Both positive and negative urgency were significant mechanisms of change in reducing substance use following treatment. Results are discussed focused on the utility of MRBP as a clinical intervention for at-risk, marginalized, and young adults.",2019,"Conclusions MBRP is a viable and useful intervention for young adults in residential treatment for substance use disorders and can aid in marked change in facets of impulsivity.","['young adults in residential substance use disorder treatment', 'Young Adults in Residential Substance Use Disorder Treatment', 'young adults']","['MRBP', 'Mindfulness-Based Relapse Prevention', 'MBRP', 'rolling group mindfulness-based relapse prevention (MBRP) intervention']","['Impulsivity Trajectories', 'trait impulsivity', 'impulsivity facets']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0038586', 'cui_str': 'Substance use disorder'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0679867', 'cui_str': 'Relapse prevention'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0021125', 'cui_str': 'Impulsive behaviour'}, {'cui': 'C0222679', 'cui_str': 'Structure of articular surface of bone'}]",,0.0290944,"Conclusions MBRP is a viable and useful intervention for young adults in residential treatment for substance use disorders and can aid in marked change in facets of impulsivity.","[{'ForeName': 'Jordan P', 'Initials': 'JP', 'LastName': 'Davis', 'Affiliation': 'Department of Children, Youth, and Families Suzanne Dworak-Peck School of Social Work, University of Southern California, 669 W 34th Street, Los Angeles, CA 90089, USA.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Barr', 'Affiliation': 'Department of Children, Youth, and Families Suzanne Dworak-Peck School of Social Work, University of Southern California, 669 W 34th Street, Los Angeles, CA 90089, USA.'}, {'ForeName': 'Emily R', 'Initials': 'ER', 'LastName': 'Dworkin', 'Affiliation': 'Center for the Study of Health and Risk Behaviors, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Tara M', 'Initials': 'TM', 'LastName': 'Dumas', 'Affiliation': 'Department of Psychology, Huron University College at Western University, London, ON, Canada.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Berey', 'Affiliation': 'Department of Health Education and Behavior, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'DiGuiseppi', 'Affiliation': 'Department of Children, Youth, and Families Suzanne Dworak-Peck School of Social Work, University of Southern California, 669 W 34th Street, Los Angeles, CA 90089, USA.'}, {'ForeName': 'Baruch', 'Initials': 'B', 'LastName': 'Rael Cahn', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Brain and Creativity Institute, USC Center for Mindfulness Science, University of Southern California, Los Angeles, CA, USA.'}]",Mindfulness,['10.1007/s12671-019-01164-0'] 2336,32595794,Grip Exercise of Non-Paretic Hand Can Improve Venous Return in the Paretic Arm in Stroke Patients: An Experimental Study in the Supine and Sitting Positions.,"Objective : This study aims to determine the effect of grip exercise by the non-paretic hand on venous return in the paretic arm in stroke in sitting and supine positions. Methods : The study population included 21 stroke patients (mean age, 59.5 years). The diameter (mm) and time-averaged mean velocity (TAMV) (cm/s) of the axillary vein on the paretic side were measured by ultrasound during three distinct conditions: resting, rhythmic non-resistive grip exercise, and resistive exercise (30% of maximum grip strength) in supine and sitting positions. The venous flow volume (ml/min) was calculated using the obtained data. Results : In the supine and sitting positions, the venous flow volume during rhythmic non-resistive and resistive exercises was increased in comparison to resting, which resulted in more increased venous flow volume by rhythmic resistive grip exercise than by non-resistive grip exercise (both, p=0.01). Conclusion : Grip exercise by the non-paretic hand was found to be effective for increasing the venous flow volume in the paretic hand, and resistive grip exercise caused the greatest increase. Our results suggest that rhythmic handgrip exercise may be clinically useful for reducing the incidence of hand edema in stroke patients.",2020,"Grip exercise by the non-paretic hand was found to be effective for increasing the venous flow volume in the paretic hand, and resistive grip exercise caused the greatest increase.","['21 stroke patients (mean age, 59.5 years', 'stroke patients', 'Stroke Patients']","['rhythmic resistive grip exercise than by non-resistive grip exercise', 'rhythmic handgrip exercise', 'grip exercise', 'Grip Exercise of Non', 'Grip exercise']","['diameter (mm) and time-averaged mean velocity (TAMV', 'venous flow volume', 'rhythmic non-resistive grip exercise, and resistive exercise']","[{'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0454331', 'cui_str': 'Gripping exercises'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0429874', 'cui_str': 'Venous flow'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0454331', 'cui_str': 'Gripping exercises'}, {'cui': 'C0203991', 'cui_str': 'Resistive exercise'}]",,0.0230947,"Grip exercise by the non-paretic hand was found to be effective for increasing the venous flow volume in the paretic hand, and resistive grip exercise caused the greatest increase.","[{'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Hayashi', 'Affiliation': 'Faculty of Care and Rehabilitation, Division of Occupational Therapy, Seijoh University, Tokai, Aichi, Japan.'}, {'ForeName': 'Motoyuki', 'Initials': 'M', 'LastName': 'Abe', 'Affiliation': 'Faculty of Care and Rehabilitation, Division of Physical Therapy, Seijoh University, Tokai, Aichi, Japan.'}]",Annals of vascular diseases,['10.3400/avd.oa.20-00024'] 2337,32595879,Cognitive stimulation program in mild cognitive impairment A randomized controlled trial.,"Non-pharmacological cognitive interventions in mild cognitive impairment have demonstrated promising results in preventing or delaying cognitive impairment and functional disability. Cognitive stimulation seems to improve and maintain cognitive and social activity. Objective This study aimed to evaluate the impact of a cognitive stimulation program in mild cognitive impairment (MCI) at the cognitive level on activities of daily living (ADLs), and levels of anxiety and depression. Methods A randomized controlled single-blind trial involving 122 non-institutionalized elderly with a MEC-35 score of 24-27 was conducted. The intervention group (n=54) received the intervention (10-week cognitive stimulation program) and was compared with a control group (n=68) that received no intervention. Follow-up assessments were conducted post-test and at 6 months post-test. The primary outcome was cognitive function determined by changes in scores on the Spanish version (MEC-35) of the Mini-Mental State Examination, while the secondary outcomes were measured by the Barthel Index, Lawton and Brody Scale, Goldberg Questionnaire (anxiety sub-scale) and the Yesavage Geriatric Depression Scale (15-item version). Results The intervention group showed a significant improvement in cognitive function at both timepoints, post-test and 6-month follow-up. The Barthel Index was higher in the intervention group, but only on the post-test analysis. The intervention did not improve the performance of instrumental ADLs or depression or anxiety levels. Conclusion The findings showed cognitive improvements in an elderly population with MCI in the short and medium-term and improved basic ADLs in the short term. Clinicaltrials.gov Identifier: NCT03831061.",2020,"The intervention group showed a significant improvement in cognitive function at both timepoints, post-test and 6-month follow-up.","['mild cognitive impairment', 'mild cognitive impairment (MCI', '122 non-institutionalized elderly with a MEC-35 score of 24-27 was conducted']","['Cognitive stimulation program', 'control group (n=68) that received no intervention', 'cognitive stimulation program', 'intervention (10-week cognitive stimulation program']","['Barthel Index', 'cognitive function determined by changes in scores on the Spanish version (MEC-35) of the Mini-Mental State Examination, while the secondary outcomes', 'cognitive function', 'Barthel Index, Lawton and Brody Scale, Goldberg Questionnaire (anxiety sub-scale) and the Yesavage Geriatric Depression Scale (15-item version', 'performance of instrumental ADLs or depression or anxiety levels', 'activities of daily living (ADLs), and levels of anxiety and depression']","[{'cui': 'C1270972', 'cui_str': 'Mild cognitive disorder'}, {'cui': 'C0562359', 'cui_str': 'Institutionalized'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0206694', 'cui_str': 'Mucoepidermoid carcinoma'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}]","[{'cui': 'C0150174', 'cui_str': 'Cognitive stimulation'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0451019', 'cui_str': 'Barthel index'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0037750', 'cui_str': 'Spanish language'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0206694', 'cui_str': 'Mucoepidermoid carcinoma'}, {'cui': 'C0451306', 'cui_str': 'Mini-mental state examination'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0451184', 'cui_str': 'Geriatric depression scale'}, {'cui': 'C0001288', 'cui_str': 'Activity of daily living'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}]",122.0,0.0509389,"The intervention group showed a significant improvement in cognitive function at both timepoints, post-test and 6-month follow-up.","[{'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Gomez-Soria', 'Affiliation': 'University of Zaragoza Ringgold standard institution Zaragoza, Aragón, Spain.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Peralta-Marrupe', 'Affiliation': 'Royal Devon and Exeter Hospital Ringgold standard institution Barrack Road, Exeter EX2 5DW United Kingdom of Great Britain and Northern Ireland.'}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Plo', 'Affiliation': 'University of Zaragoza Ringgold standard institution Zaragoza, Aragón, Spain.'}]",Dementia & neuropsychologia,['10.1590/1980-57642020dn14-020003'] 2338,32595880,Action observation combined with gait training to improve gait and cognition in elderly with mild cognitive impairment A randomized controlled trial.,"Owing to advancement of medical technology and current knowledge, the population has a longer life expectancy, leading to an increase in the proportion of elderly. Objective The study aimed to investigate the effect of action observation (AO) combined with gait training on gait and cognition in elderly with mild cognitive impairment (MCI). Methods Thirty-three participants were randomly allocated to action observation with gait training (AOGT), gait training (GT), and control (CT) groups. The AOGT and GT groups received a program of observation and gait training protocol with the same total duration of 65 min for 12 sessions. For the observation, the AGOT group watched a video of normal gait movement, while the GT group watched an abstract picture and the CT group received no training program. All participants were assessed for gait parameters during single- and dual-tasks using an electronic gait mat system and were assessed for cognitive level using the Montreal Cognitive Assessment (MoCA) at baseline, after training and at 1-month follow-up. Results The results showed that the AOGT group had significant improvements in gait speeds during single- and dual-tasks, as well as better MoCA score, while the GT group had significant improvement only in gait speed. Conclusion The adjunct treatment of AO with gait training provides greater benefits for both gait and cognitive performances in elderly with MCI.",2020,"The results showed that the AOGT group had significant improvements in gait speeds during single- and dual-tasks, as well as better MoCA score, while the GT group had significant improvement only in gait speed. ","['elderly with mild cognitive impairment', 'elderly with MCI', 'elderly with mild cognitive impairment (MCI', 'Thirty-three participants']","['gait training', 'CT group received no training program', 'AO with gait training', 'action observation with gait training (AOGT), gait training (GT), and control (CT', 'action observation (AO) combined with gait training']","['gait and cognition', 'gait speeds', 'MoCA score', 'gait speed', 'cognitive level using the Montreal Cognitive Assessment (MoCA']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C1270972', 'cui_str': 'Mild cognitive disorder'}, {'cui': 'C0450358', 'cui_str': '33'}]","[{'cui': 'C0085673', 'cui_str': 'Gait training procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C4721272', 'cui_str': 'Montreal cognitive assessment score'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C4555213', 'cui_str': 'Assessment using Montreal cognitive assessment'}, {'cui': 'C0025750', 'cui_str': ""3,3'-Dichloro-4,4'-Diaminodiphenylmethane""}]",33.0,0.0191868,"The results showed that the AOGT group had significant improvements in gait speeds during single- and dual-tasks, as well as better MoCA score, while the GT group had significant improvement only in gait speed. ","[{'ForeName': 'Rommanee', 'Initials': 'R', 'LastName': 'Rojasavastera', 'Affiliation': 'Faculty of Physical Therapy, Mahidol University, Nakhon Pathom, Thailand.'}, {'ForeName': 'Sunee', 'Initials': 'S', 'LastName': 'Bovonsunthonchai', 'Affiliation': 'Faculty of Physical Therapy, Mahidol University, Nakhon Pathom, Thailand.'}, {'ForeName': 'Vimonwan', 'Initials': 'V', 'LastName': 'Hiengkaew', 'Affiliation': 'Faculty of Physical Therapy, Mahidol University, Nakhon Pathom, Thailand.'}, {'ForeName': 'Vorapun', 'Initials': 'V', 'LastName': 'Senanarong', 'Affiliation': 'Division of Neurology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}]",Dementia & neuropsychologia,['10.1590/1980-57642020dn14-020004'] 2339,32595896,Outcome comparison between diode laser pulpotomy and formocresol pulpotomy on human primary molars.,"Background/purpose Diode laser is widely used in dentistry, especially on treating soft tissues. Currently neither the effect of diode laser pulpotomy nor its comparison with formocresol (FC) pulpotomy has been fully investigated. Therefore the purpose of this study was to investigate the clinical and radiographic outcomes of diode laser pulpotomy and formocresol pulpotomy on human primary molars. Materials and methods Healthy two-to eight-year-olds were treated with pulpotomies on primary molars as part of their regular dental treatment. The pulpotomy teeth were randomly assigned into one of two groups. The experimental group was treated with diode laser; the control group was treated with 1:5 dilution FC. Results Forty-five teeth with diode laser and 45 teeth with FC in 70 healthy children were studied. In 12 months follow-up, the clinical success rates were 92.9%, and 90.9% for laser and FC respectively, and the radiographic success rates were 78.6%, and 72.7% for laser and FC respectively. Conclusion: There is no significant difference of clinical and radiographic success rate between diode laser and FC pulpotomy in human primary molars followed for 12 months.",2020,"In 12 months follow-up, the clinical success rates were 92.9%, and 90.9% for laser and FC respectively, and the radiographic success rates were 78.6%, and 72.7% for laser and FC respectively.","['70 healthy children', 'Forty-five teeth with', 'human primary molars']","['diode laser pulpotomy', 'Diode laser', 'diode laser', 'diode laser pulpotomy and formocresol pulpotomy', 'diode laser and FC pulpotomy', 'diode laser and 45 teeth with FC']","['radiographic success rates', 'clinical success rates']","[{'cui': 'C0686744', 'cui_str': 'Well child'}, {'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}]","[{'cui': 'C0392254', 'cui_str': 'Semiconductor laser device'}, {'cui': 'C0034104', 'cui_str': 'Pulpotomy'}, {'cui': 'C0016583', 'cui_str': 'Formocresols'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}]","[{'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}]",70.0,0.0181779,"In 12 months follow-up, the clinical success rates were 92.9%, and 90.9% for laser and FC respectively, and the radiographic success rates were 78.6%, and 72.7% for laser and FC respectively.","[{'ForeName': 'Shan-Li', 'Initials': 'SL', 'LastName': 'Pei', 'Affiliation': 'School of Dentistry, National Taiwan University, Taipei, Taiwan.'}, {'ForeName': 'Wen-Yu', 'Initials': 'WY', 'LastName': 'Shih', 'Affiliation': 'School of Dentistry, National Yang Ming University, Taipei, Taiwan.'}, {'ForeName': 'Jeng-Fen', 'Initials': 'JF', 'LastName': 'Liu', 'Affiliation': 'School of Dentistry, National Yang Ming University, Taipei, Taiwan.'}]",Journal of dental sciences,['10.1016/j.jds.2020.03.005'] 2340,32595899,The discoloration effect of diluted minocycline containing triple antibiotic gel used in revascularization.,"Background/purpose Triple antibiotic paste (TAP) has been successfully used in revascularization procedure. However, one of the problems associated with TAP use is teeth discoloration, which is attributed to the presence of minocycline constituent. The aim of this study is to investigate the discoloration effect of different concentrations of triple (TAP) and double (DAP) antibiotics pastes on root dentine. Materials and methods Sterilized dentine specimens (4 × 4 × 1) were prepared, and randomly assigned to 5 groups; 1000 mg/mL of Triple antibiotic paste (TAP), 1000 mg/mL of Double antibiotic paste (DAP), 1 mg/mL of TAP in Methylcellulose gel (MTAP), 1 mg/mL of DAP in Methylcellulose gel (MDAP), and distilled water control groups (n = 12). The assigned treatment was applied for 14 days. The CIE L*a*b calorimetric parameters were measured for all dentine specimens using a Chroma meter. One-way ANOVA and multiple comparisons were used for statistical analyses (p < 0.05). ΔE for the different treatments as compared to distilled water group was calculated. Results TAP and MTAP groups significantly affects the L* values of the root dentine (p < 0.05). ΔE change was noticeable between TAP and MTAP compared to the distilled water group. Conclusion The incorporation of minocycline in TAP medicaments, even in low concentrations, can still provoke a noticeable tooth discoloration.",2020,groups significantly affects the L* values of the root dentine (p < 0.05).,[],"['Triple antibiotic paste (TAP', 'TAP and MTAP', 'diluted minocycline', 'Triple antibiotic paste (TAP), 1000\xa0mg/mL of Double antibiotic paste (DAP), 1\xa0mg/mL of TAP in Methylcellulose gel (MTAP), 1\xa0mg/mL of DAP in Methylcellulose gel (MDAP), and distilled water control', 'minocycline', 'triple (TAP) and double (DAP) antibiotics pastes']","['L* values of the root dentine', 'discoloration effect']",[],"[{'cui': 'C0205174', 'cui_str': 'Triple'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0030634', 'cui_str': 'Pastes'}, {'cui': 'C1720119', 'cui_str': 'Dilute'}, {'cui': 'C0026187', 'cui_str': 'Minocycline'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0439294', 'cui_str': 'g/L'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0025729', 'cui_str': 'Methylcellulose'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0011429', 'cui_str': 'Dentin structure'}, {'cui': 'C0332572', 'cui_str': 'Abnormal color'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",,0.0302395,groups significantly affects the L* values of the root dentine (p < 0.05).,"[{'ForeName': 'Alaa H A', 'Initials': 'AHA', 'LastName': 'Sabrah', 'Affiliation': 'Department of Conservative Dentistry, The University of Jordan, Amman, Jordan.'}, {'ForeName': 'Ayah A', 'Initials': 'AA', 'LastName': 'Al-Asmar', 'Affiliation': 'Department of Conservative Dentistry, The University of Jordan, Amman, Jordan.'}, {'ForeName': 'Firas', 'Initials': 'F', 'LastName': 'Alsoleihat', 'Affiliation': 'Department of Conservative Dentistry, The University of Jordan, Amman, Jordan.'}, {'ForeName': 'Heba', 'Initials': 'H', 'LastName': 'Al-Zer', 'Affiliation': 'Department of Conservative Dentistry, The University of Jordan, Amman, Jordan.'}]",Journal of dental sciences,['10.1016/j.jds.2019.06.005'] 2341,32596148,Early Detection of Non-Small Cell Lung Cancer by Using a 12-microRNA Panel and a Nomogram for Assistant Diagnosis.,"Background: We previously identified a 12-microRNA (miRNA) panel (miRNA-17, miRNA-146a, miRNA-200b, miRNA-182, miRNA-155, miRNA-221, miRNA-205, miRNA-126, miRNA-7, miRNA-21, miRNA-145, and miRNA-210) that aided in the early diagnosis of non-small cell lung cancer (NSCLC). We validated the diagnostic value of this miRNA panel and compared it with that of traditional tumor markers and radiological diagnosis. We constructed a nomogram based on the miRNA panel's results to predict the risk of NSCLC. Methods: Eighty-two participants with pulmonary nodules on a CT scan and who underwent a pathological examination and surgical treatment were enrolled in our study. Patients were randomly divided into a training group or a validation group. The miRNA concentrations were quantified by RT-PCR and log-transformed for analysis. The cutoff value was determined in the training group and then applied in the validation group. A comparison between the miRNAs and traditional tumor markers [CEA, NSE, and cytokeratin 19 fragment 21-1 (Cyfra21-1)] and radiological diagnosis was performed. A nomogram based on the miRNA panel's results to predict the risk of NSCLC was constructed. Results: The expression level of these 12 miRNAs was significantly higher in NSCLC patients than in benign patients. In the validation group, the specificity and positive predictive value were 96.4 and 95.8%, respectively, which were significantly higher than those using traditional tumor markers or radiological diagnosis. The sensitivity was 42.6%, which was also higher than that using tumor markers. Moreover, the sensitivity increased to 63.6% when the nodule diameters were larger than 2 cm. The miRNAs and seven clinical factors were integrated into the nomogram, and the calibration curves showed optimal agreement between the predicted and actual probabilities. Conclusions: Our miRNA panel has clinical value for the early detection of NSCLC. A nomogram was constructed and internally validated, and the results indicate that it can assist clinicians in making treatment recommendations in the clinic.",2020,"A comparison between the miRNAs and traditional tumor markers [CEA, NSE, and cytokeratin 19 fragment 21-1 (Cyfra21-1)] and radiological diagnosis was performed.",['Eighty-two participants with pulmonary nodules on a CT scan and who underwent a pathological examination and surgical treatment were enrolled in our study'],[],"['miRNA concentrations', 'specificity and positive predictive value', 'expression level', 'sensitivity']","[{'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0034079', 'cui_str': 'Nodule of lung'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]",[],"[{'cui': 'C1101610', 'cui_str': 'MicroRNA'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0037791', 'cui_str': 'Specificity'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}]",82.0,0.0226138,"A comparison between the miRNAs and traditional tumor markers [CEA, NSE, and cytokeratin 19 fragment 21-1 (Cyfra21-1)] and radiological diagnosis was performed.","[{'ForeName': 'Weidong', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'Department of Thoracic Surgery, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Dongni', 'Initials': 'D', 'LastName': 'Chen', 'Affiliation': 'Department of Thoracic Surgery, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Weiwei', 'Initials': 'W', 'LastName': 'Chen', 'Affiliation': 'Department of Thoracic Surgery, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Ziya', 'Initials': 'Z', 'LastName': 'Xin', 'Affiliation': 'Department of Thoracic Surgery, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Zirui', 'Initials': 'Z', 'LastName': 'Huang', 'Affiliation': 'Department of Thoracic Surgery, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Xuewen', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'State Key Laboratory of Oncology in South China, Sun Yat-sen University Cancer Center, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China.'}, {'ForeName': 'Kexing', 'Initials': 'K', 'LastName': 'Xi', 'Affiliation': 'Department of Colorectal Surgery, Peking Union Medical College, National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences, Beijing, China.'}, {'ForeName': 'Gongming', 'Initials': 'G', 'LastName': 'Wang', 'Affiliation': 'Department of Thoracic Surgery, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Rusi', 'Initials': 'R', 'LastName': 'Zhang', 'Affiliation': 'Department of Thoracic Surgery, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Dechang', 'Initials': 'D', 'LastName': 'Zhao', 'Affiliation': 'Department of Thoracic Surgery, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Department of Thoracic Surgery, Sun Yat-sen University Cancer Center, Guangzhou, China.'}, {'ForeName': 'Lanjun', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Department of Thoracic Surgery, Sun Yat-sen University Cancer Center, Guangzhou, China.'}]",Frontiers in oncology,['10.3389/fonc.2020.00855'] 2342,32596186,The Impact of Combined Risk-Reducing Gynecological Surgeries on Outcomes in DIEP Flap and Tissue-Expander Breast Reconstruction.,"Introduction In addition to prophylactic mastectomies, BRCA1 and BRCA2 mutation carriers are increasingly choosing to undergo risk-reducing procedures such as hysterectomies and salpingo-oophorectomies. Sometimes these surgeries are performed in the same visit as a mastectomy or a revisionary reconstruction procedure. Literature lacks descriptions of complications and trends for these combined surgeries. Methods Group 1 patients (n = 10, flaps = 20) had abdominal gynecologic procedures at the time of deep inferior epigastric artery perforator flap (DIEP flap) reconstruction. Group 2 patients (n = 29, breasts = 58) had gynecologic procedures at the time of mastectomy and tissue-expander placement. Group 3 patients (n = 141, breasts = 257) had mastectomy and tissue-expander reconstruction without gynecologic procedures and were used as a control group for group 2. Group 4 patients (n = 357, flaps = 673) had autologous breast reconstruction without gynecologic procedures and were used as a control for group 1. Categorical variables such as complications and flap loss were analyzed using χ 2 tests. Continuous variables such as age, body mass index (BMI), operative time, length of stay were analyzed with 2-tailed t tests. Multivariate analyses were run to control for group differences. Results Groups 1 and 4 were equivalent in age and comorbidities, except group 1 (32.8 kg/m 2 ) had significantly higher BMI than group 4 (31.4 kg/m 2 ), P = .028. Average operating time was statistically equivalent for group 1 patients (610 minutes) and group 4 patients (503 minutes), P = .289. Average hospital stay was equivalent as well (group 1 = 4.4 days, group 4 = 4.1 days, P = .676). Operative times for group 2 patients (457 minutes) were significantly longer than for group 3 patients (288 minutes), P < .01. Group 2 patients (3 nights) had significantly longer hospital stays than group 3 patients (2 nights), P < .01. Group 1 patients (2/20 flaps, 10%) had a significantly higher rate of flap loss than group 4 patients (8/673 flaps, 1%), P < .01. There were no differences in other flap complications. Additionally, there were no significant differences in postoperative tissue-expander complications between group 2 and group 3. Discussion Both flap losses in Group 1 patients occurred in a single patient with BMI = 39.3 kg/m 2 and a personal history of recurrent DVTs. Additionally, the rates of complications across other measures were equivalent between groups. Thus, despite the increased rate of flap loss in Group 1 (10%) vs Group 4 (1.3%), along with the increased operative times and hospital stays, certain patients can be advised that a prophylactic gynecological procedure is safe to combine with breast reconstruction.",2020,"Operative times for group 2 patients (457 minutes) were significantly longer than for group 3 patients (288 minutes), ","['Group 2 patients (n = 29, breasts = 58) had gynecologic procedures at the time of mastectomy and tissue-expander placement']","['deep inferior epigastric artery perforator flap (DIEP flap) reconstruction', 'autologous breast reconstruction without gynecologic procedures', 'Combined Risk-Reducing Gynecological Surgeries', 'mastectomy and tissue-expander reconstruction without gynecologic procedures']","['Operative times', 'longer hospital stays', 'flap complications', 'body mass index (BMI), operative time, length of stay', 'complications and flap loss', 'Average hospital stay', 'rate of flap loss', 'Average operating time', 'flap losses', 'rates of complications', 'operative times and hospital stays', 'postoperative tissue-expander complications', 'abdominal gynecologic procedures']","[{'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0205480', 'cui_str': 'Gynecologic'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0024881', 'cui_str': 'Mastectomy'}, {'cui': 'C0040289', 'cui_str': 'Tissue expander'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]","[{'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0226401', 'cui_str': 'Structure of inferior epigastric artery'}, {'cui': 'C3494192', 'cui_str': 'Perforator Flaps'}, {'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0085076', 'cui_str': 'Mammoplasty'}, {'cui': 'C0205480', 'cui_str': 'Gynecologic'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0038902', 'cui_str': 'Operation on female genital organs'}, {'cui': 'C0024881', 'cui_str': 'Mastectomy'}, {'cui': 'C0040289', 'cui_str': 'Tissue expander'}]","[{'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0038925', 'cui_str': 'Flap'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0406864', 'cui_str': 'Flap loss'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0040289', 'cui_str': 'Tissue expander'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0205480', 'cui_str': 'Gynecologic'}, {'cui': 'C0025664', 'cui_str': 'methods'}]",,0.0165862,"Operative times for group 2 patients (457 minutes) were significantly longer than for group 3 patients (288 minutes), ","[{'ForeName': 'Avinash P', 'Initials': 'AP', 'LastName': 'Jayaraman', 'Affiliation': 'Department of Plastic Surgery, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Travis', 'Initials': 'T', 'LastName': 'Boyd', 'Affiliation': 'Department of Plastic Surgery, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Savannah N', 'Initials': 'SN', 'LastName': 'Hampton', 'Affiliation': 'Department of Plastic Surgery, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Nicholas T', 'Initials': 'NT', 'LastName': 'Haddock', 'Affiliation': 'Department of Plastic Surgery, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Sumeet S', 'Initials': 'SS', 'LastName': 'Teotia', 'Affiliation': 'Department of Plastic Surgery, University of Texas Southwestern Medical Center, Dallas, TX, USA.'}]","Plastic surgery (Oakville, Ont.)",['10.1177/2292550320925905'] 2343,32596199,Taking a Stand for Office-Based Workers' Mental Health: The Return of the Microbreak.,"There is evidence that movement-based microbreaks can improve the cardiovascular health of desk-based employees, but their effect on mood states is yet to be investigated. As daily work tasks can potentially result in the loss of physical and psychological resources, the objective of this study was to measure the effect of movement microbreaks during formal work time on mood states. In a randomized-controlled pilot study with repeated measures (baseline, post-test, washout) of self-reported job stress and mood states (fatigue and vigor), police officers ( N = 43) were exposed to movement microbreaks during work hours. A multivariate significant difference between groups was noted after the intervention period. Further analysis revealed that the experimental group reported a latent reduction in job-related stress after the 3-months washout period. Although the study was conducted with a small sample, our preliminary findings suggest that interrupting sedentary work with movement microbreaks may have beneficial effects on employee mental health. The implications of movement microbreaks for mitigating work-related stress of first responders, including police, is discussed, along with directives for future research.",2020,Further analysis revealed that the experimental group reported a latent reduction in job-related stress after the 3-months washout period.,"[""Taking a Stand for Office-Based Workers' Mental Health""]",[],[],"[{'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}]",[],[],43.0,0.0588066,Further analysis revealed that the experimental group reported a latent reduction in job-related stress after the 3-months washout period.,"[{'ForeName': 'Casey Peter', 'Initials': 'CP', 'LastName': 'Mainsbridge', 'Affiliation': 'School of Education, Launceston, TAS, Australia.'}, {'ForeName': 'Dean', 'Initials': 'D', 'LastName': 'Cooley', 'Affiliation': 'School of Education, Ballarat, VIC, Australia.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Dawkins', 'Affiliation': 'Tasmanian School of Business and Economics, Hobart, TAS, Australia.'}, {'ForeName': 'Kristy', 'Initials': 'K', 'LastName': 'de Salas', 'Affiliation': 'School of Technology, Environments, and Design, Hobart, TAS, Australia.'}, {'ForeName': 'Jiajin', 'Initials': 'J', 'LastName': 'Tong', 'Affiliation': 'School of Psychological and Cognitive Sciences, Beijing Key Laboratory of Behavior and Mental Health, Beijing, China.'}, {'ForeName': 'Matthew Wade', 'Initials': 'MW', 'LastName': 'Schmidt', 'Affiliation': 'School of Health Sciences, Hobart, TAS, Australia.'}, {'ForeName': 'Scott J', 'Initials': 'SJ', 'LastName': 'Pedersen', 'Affiliation': 'School of Education, Launceston, TAS, Australia.'}]",Frontiers in public health,['10.3389/fpubh.2020.00215'] 2344,32596337,Comparison in Sedative Effects between Dexmedetomidine and Midazolam in Dental Implantation: A Randomized Clinical Trial.,"Dexmedetomidine refers to an α 2 -adrenergic receptor agonist causing potent sedative, analgesic, and minimal respiratory depression compared with alternative drugs. The present study was aimed at comparing the efficaciousness and safety of midazolam and dexmedetomidine as sedatives for dental implantation. We recruited 60 patients belonging to group I or II of the American Society of Anesthesiologists (ASA) and treated them with either midazolam or dexmedetomidine in a random manner. Patients' duration of analgesia after surgery, surgeon and patient degrees of satisfaction, Observer's Assessment of Alertness/Sedation Scale (OAAS) scores after drug administration, visual analogue scale (VAS) pain scores, and vital signs were recorded variables. Patients administered dexmedetomidine had significantly lower OAAS scores than those administered midazolam ( p < 0.05). Patients administrated dexmedetomidine had a significantly longer analgesia duration after the surgical procedure than those administered midazolam, and the difference was statistically significant ( p < 0.05). Dexmedetomidine had a significantly larger number of surgeons satisfied with the level of sedation/analgesia than midazolam ( p < 0.05). Accordingly, it is considered that dexmedetomidine can achieve better postoperative analgesia, surgeon satisfaction, and sedation than midazolam.",2020,Patients administered dexmedetomidine had significantly lower OAAS scores than those administered midazolam ( p < 0.05).,"['Dental Implantation', '60 patients belonging to group']","['Dexmedetomidine', 'Dexmedetomidine and Midazolam', 'midazolam or dexmedetomidine', 'midazolam', 'midazolam and dexmedetomidine', 'dexmedetomidine']","[""duration of analgesia after surgery, surgeon and patient degrees of satisfaction, Observer's Assessment of Alertness/Sedation Scale (OAAS) scores after drug administration, visual analogue scale (VAS) pain scores, and vital signs"", 'analgesia duration', 'postoperative analgesia, surgeon satisfaction, and sedation', 'number of surgeons satisfied with the level of sedation/analgesia', 'OAAS scores']","[{'cui': 'C0011370', 'cui_str': 'Dental implantation'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0026056', 'cui_str': 'Midazolam'}]","[{'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0150270', 'cui_str': 'Management of drug regimen'}, {'cui': 'C2732809', 'cui_str': 'Visual analog scale pain score'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C0237753', 'cui_str': 'Number'}]",60.0,0.143191,Patients administered dexmedetomidine had significantly lower OAAS scores than those administered midazolam ( p < 0.05).,"[{'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'The State Key Laboratory Breeding Base of Basic Science of Stomatology (Hubei-MOST) and Key Laboratory of Oral Biomedicine Ministry of Education, School and Hospital of Stomatology, Wuhan University, Wuhan, Hubei 430079, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'The State Key Laboratory Breeding Base of Basic Science of Stomatology (Hubei-MOST) and Key Laboratory of Oral Biomedicine Ministry of Education, School and Hospital of Stomatology, Wuhan University, Wuhan, Hubei 430079, China.'}, {'ForeName': 'Tiejun', 'Initials': 'T', 'LastName': 'Zhang', 'Affiliation': 'The State Key Laboratory Breeding Base of Basic Science of Stomatology (Hubei-MOST) and Key Laboratory of Oral Biomedicine Ministry of Education, School and Hospital of Stomatology, Wuhan University, Wuhan, Hubei 430079, China.'}, {'ForeName': 'Lili', 'Initials': 'L', 'LastName': 'Huang', 'Affiliation': 'The State Key Laboratory Breeding Base of Basic Science of Stomatology (Hubei-MOST) and Key Laboratory of Oral Biomedicine Ministry of Education, School and Hospital of Stomatology, Wuhan University, Wuhan, Hubei 430079, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Peng', 'Affiliation': 'The State Key Laboratory Breeding Base of Basic Science of Stomatology (Hubei-MOST) and Key Laboratory of Oral Biomedicine Ministry of Education, School and Hospital of Stomatology, Wuhan University, Wuhan, Hubei 430079, China.'}]",BioMed research international,['10.1155/2020/6130162'] 2345,32596348,Acute Caffeine Mouth Rinse Does Not Change the Hydration Status following a 10 km Run in Recreationally Trained Runners.,"Background and Aims Caffeine mouth rinsing has emerged as an alternative to oral caffeine consumption for improving performance without provoking lower gastrointestinal distress. However, it remains unclear if hydration status and sweat rate are negatively affected by caffeine mouth rinsing. This study is aimed at evaluating the effects of 10 seconds of caffeine mouth rinsing (1.2% anhydrous caffeine solution) on hydration status and sweat rate following a 10 km run trial. Methods Ten recreationally trained runners (30.1 ± 6.4 y) volunteered to participate in this double-blind, placebo-controlled, and crossover research study. Participants completed two 10 km run trials separated by approximately one week. Immediately prior to running, participants completed a 10-second mouth rinse protocol with either 300 mg of caffeine or microcrystalline cellulose (placebo) diluted in 25 mL of water. The effects of caffeine mouth rinsing on hydration status and sweat rate were assessed following a 10 km run trial. Results Sweat rate (placebo: 15.34 ± 9.71 vs. caffeine: 11.91 ± 6.98 mL · min -1 ; p = 0.39), dehydration (placebo: 1.20 ± 0.57 vs. caffeine: 1.49 ± 0.29%; p = 0.15), and hydration (placebo: 15.32 ± 9.71 vs. caffeine: 11.89 ± 6.99 mL · min -1 ; p = 0.37) measures were not significantly different between trials. Conclusion Caffeine mouth rinse does not appear to alter the hydration status or sweat rate following a 10 km run.",2020,"Results Sweat rate (placebo: 15.34 ± 9.71 vs. caffeine: 11.91 ± 6.98 mL · min -1 ; p = 0.39), dehydration (placebo: 1.20 ± 0.57 vs. caffeine: 1.49 ± 0.29%; p = 0.15), and hydration (placebo: 15.32 ± 9.71 vs. caffeine: 11.89 ± 6.99 mL · min -1 ; p = 0.37) measures were not significantly different between trials. ","['Methods\n\n\nTen recreationally trained runners (30.1 ± 6.4\u2009y) volunteered to participate in this double-blind', 'Recreationally Trained Runners']","['caffeine mouth rinsing (1.2% anhydrous caffeine solution', 'Acute Caffeine Mouth Rinse', 'placebo', 'caffeine', 'caffeine mouth rinsing', 'caffeine or microcrystalline cellulose (placebo']","['hydration status or sweat rate', 'hydration status and sweat rate']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C4517822', 'cui_str': '6.4'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}]","[{'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C4068880', 'cui_str': '1.2'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0026647', 'cui_str': 'Oromucosal solution for gargle'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0669247', 'cui_str': 'microcrystalline cellulose'}]","[{'cui': 'C1321013', 'cui_str': 'Hydration status'}, {'cui': 'C0038984', 'cui_str': 'Sweat'}]",10.0,0.272339,"Results Sweat rate (placebo: 15.34 ± 9.71 vs. caffeine: 11.91 ± 6.98 mL · min -1 ; p = 0.39), dehydration (placebo: 1.20 ± 0.57 vs. caffeine: 1.49 ± 0.29%; p = 0.15), and hydration (placebo: 15.32 ± 9.71 vs. caffeine: 11.89 ± 6.99 mL · min -1 ; p = 0.37) measures were not significantly different between trials. ","[{'ForeName': 'Adam M', 'Initials': 'AM', 'LastName': 'Gonzalez', 'Affiliation': 'Department of Health Professions, Hofstra University, Hempstead, NY, USA.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Guimarães', 'Affiliation': 'Clinical and Sports Nutrition Research Laboratory (Labince), Faculty of Nutrition, Federal University of Goias, Goiânia, GO, Brazil.'}, {'ForeName': 'Nayra', 'Initials': 'N', 'LastName': 'Figueiredo', 'Affiliation': 'Clinical and Sports Nutrition Research Laboratory (Labince), Faculty of Nutrition, Federal University of Goias, Goiânia, GO, Brazil.'}, {'ForeName': 'Marcela', 'Initials': 'M', 'LastName': 'Queiroz', 'Affiliation': 'Clinical and Sports Nutrition Research Laboratory (Labince), Faculty of Nutrition, Federal University of Goias, Goiânia, GO, Brazil.'}, {'ForeName': 'Paulo', 'Initials': 'P', 'LastName': 'Gentil', 'Affiliation': 'College of Physical Education and Dance, Federal University of Goias, Goiania, GO, Brazil.'}, {'ForeName': 'João F', 'Initials': 'JF', 'LastName': 'Mota', 'Affiliation': 'Clinical and Sports Nutrition Research Laboratory (Labince), Faculty of Nutrition, Federal University of Goias, Goiânia, GO, Brazil.'}, {'ForeName': 'Gustavo D', 'Initials': 'GD', 'LastName': 'Pimentel', 'Affiliation': 'Clinical and Sports Nutrition Research Laboratory (Labince), Faculty of Nutrition, Federal University of Goias, Goiânia, GO, Brazil.'}]",BioMed research international,['10.1155/2020/6598753'] 2346,32596367,Photobiomodulation and Pain Reduction in Patients Requiring Orthodontic Band Application: Randomized Clinical Trial.,"Purpose The aim of this study was to investigate the effect of Photobiomodulation (PBM) in managing orthodontic pain intensity over time in patients requiring band application on upper first molars. Methods Maxillary first molars were banded. In the trial group, each molar received single-session PBM on two buccal and two palatal points ( λ = 830 ± 10 nm; 150 mW, 7.5 J/cm 2 ; spot of 0.1 cm 2 ; 5 sec per point), while the control group received a placebo treatment. All patients were asked to answer five pain rating scales to assess pain intensity at 5 minutes and 1, 12, 24, and 72 hours and completed a survey describing the type of pain and its temporal course in the next 7 days. Results 26 patients (mean age 11.8 years) were randomly assigned to a control or a trial group. The trial group showed significantly lower pain intensities ( p < 0.05) at 5 min ( M = 0.92, SD = 1.32), 1 h ( M = 0.77, SD = 1.01), and 12 h ( M = 0.77, SD = 1.54) after band application compared to the control group (5 min: M = 1.62, SD = 1.26; 1 h: M = 1.77, SD = 1.92; and 12 h: M = 1.77, SD = 2.17), whereas no difference between groups ( p > 0.05) was found at 24 h (trial: M = 0.62, SD = 1.71; control: M = 1.08, SD = 1.75) and 72 h (trial: M = 0.31, SD = 0.75; control: M = 0.15, SD = 0.55). Patients in the control group reported more frequently the presence of ""compressive pain"" (58.8%, p < 0.05) from the appliance during the week after the application, while the trial group showed higher frequency of ""no pain"" (46.2%, p < 0.05). However, PBM did not affect the pain onset (trial: M = 10.86, SD = 26.97; control: M = 5.25, SD = 7.86), peak (trial: M = 15.86, SD = 26.29; control: 6.17, SD = 7.96), and end time (trial: 39.57, SD = 31.33; control: M = 22.02, SD = 25.42) reported by the two groups ( p > 0.05). Conclusions PBM might be considered a promising alternative to decrease general pain intensity, although not affecting the typical pain cycle, in terms of the onset, peak, and ending times.",2020,"The trial group showed significantly lower pain intensities ( p < 0.05) at 5 min ( M = 0.92, SD = 1.32), 1 h ( M = 0.77, SD = 1.01), and 12 h ( M = 0.77, SD = 1.54) after band application compared to the control group (5 min: M = 1.62, SD = 1.26; 1 h: M = 1.77, SD = 1.92; and 12 h: M = 1.77, SD = 2.17), whereas no difference between groups ( p > 0.05) was found at 24 h (trial: M = 0.62, SD = 1.71; control: M = 1.08, SD = 1.75) and 72 h (trial: M = 0.31, SD = 0.75; control: M = 0.15, SD = 0.55).","['Patients Requiring Orthodontic Band Application', 'patients requiring band application on upper first molars', '26 patients (mean age 11.8 years']","['placebo treatment', 'Photobiomodulation (PBM']","['Photobiomodulation and Pain Reduction', 'pain rating scales to assess pain intensity', 'general pain intensity', 'pain onset', 'frequency of ""no pain', 'presence of ""compressive pain', 'lower pain intensities']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0182064', 'cui_str': 'Orthodontic band'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0175723', 'cui_str': 'Band'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0227056', 'cui_str': 'Structure of mandibular left first molar tooth'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0234225', 'cui_str': 'No pain'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0205251', 'cui_str': 'Low'}]",,0.215544,"The trial group showed significantly lower pain intensities ( p < 0.05) at 5 min ( M = 0.92, SD = 1.32), 1 h ( M = 0.77, SD = 1.01), and 12 h ( M = 0.77, SD = 1.54) after band application compared to the control group (5 min: M = 1.62, SD = 1.26; 1 h: M = 1.77, SD = 1.92; and 12 h: M = 1.77, SD = 2.17), whereas no difference between groups ( p > 0.05) was found at 24 h (trial: M = 0.62, SD = 1.71; control: M = 1.08, SD = 1.75) and 72 h (trial: M = 0.31, SD = 0.75; control: M = 0.15, SD = 0.55).","[{'ForeName': 'Maria Francesca', 'Initials': 'MF', 'LastName': 'Sfondrini', 'Affiliation': 'Unit of Orthodontics and Paediatric Dentistry, Section of Dentistry-Department of Clinical, Surgical, Diagnostic and Paediatric Sciences, University of Pavia, Pavia, Italy.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Vitale', 'Affiliation': 'Unit of Orthodontics and Paediatric Dentistry, Section of Dentistry-Department of Clinical, Surgical, Diagnostic and Paediatric Sciences, University of Pavia, Pavia, Italy.'}, {'ForeName': 'Antonio Luiz Barbosa', 'Initials': 'ALB', 'LastName': 'Pinheiro', 'Affiliation': 'Center of Biophotonics, Dental School, Federal University of Bahia (UFBA), Salvador, BA, Brazil.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Gandini', 'Affiliation': 'Unit of Orthodontics and Paediatric Dentistry, Section of Dentistry-Department of Clinical, Surgical, Diagnostic and Paediatric Sciences, University of Pavia, Pavia, Italy.'}, {'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Sorrentino', 'Affiliation': 'Unit of Orthodontics and Paediatric Dentistry, Section of Dentistry-Department of Clinical, Surgical, Diagnostic and Paediatric Sciences, University of Pavia, Pavia, Italy.'}, {'ForeName': 'Ugo Matteo', 'Initials': 'UM', 'LastName': 'Iarussi', 'Affiliation': 'Unit of Orthodontics and Paediatric Dentistry, Section of Dentistry-Department of Clinical, Surgical, Diagnostic and Paediatric Sciences, University of Pavia, Pavia, Italy.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Scribante', 'Affiliation': 'Unit of Orthodontics and Paediatric Dentistry, Section of Dentistry-Department of Clinical, Surgical, Diagnostic and Paediatric Sciences, University of Pavia, Pavia, Italy.'}]",BioMed research international,['10.1155/2020/7460938'] 2347,32596393,"Tripterygium wilfordii Hook F Treatment for Stage IV Diabetic Nephropathy: Protocol for a Prospective, Randomized Controlled Trial.","Background Diabetic nephropathy (DN) is a major cause of chronic kidney disease (CKD). There are no effective treatments to prevent or reverse the progression of DN. A preliminary study showed that Tripterygium glycosides from Tripterygium wilfordii Hook F (TwHF) with valsartan decrease proteinuria in patients with DN. Objectives The objective of the present study is to investigate the efficacy and safety of Tripterygium glycosides from TwHF, a traditional Chinese medicine, for the treatment of DN. Methods and Analysis . This is a prospective, single-center randomized controlled trial. Seventy participants diagnosed with DN were recruited and randomized 1 : 1 to two groups: (1) angiotensin receptor blocker (ARB) combined with TwHF and (2) ARB-only. The treatment period is 48 weeks. The primary endpoint is 24 h proteinuria decreased level (reduction of 30% vs. baseline) after 48 weeks of treatment. The secondary endpoints are (1) all-cause and cardiovascular-related mortality, (2) development of ESRD (serum creatinine > 530.4  μ mol/L or estimated glomerular filtration rate (eGFR) < 15 mL/min/1.73 m 2 ), (3) the need for renal replacement therapy, and (4) increased serum creatinine (2-fold higher than the baseline value or ≥442  μ mol/L, with confirmation of the initial results after 4 weeks). A health economics analysis will be carried out. Discussion . A meta-analysis of RCTs carried out in patients with stage 4 (Mogensen classification) diabetic CKD showed that TwHF combined with an ARB was more effective than an ARB alone when considering 24 h proteinuria and serum albumin, but with an increase in adverse event (AE) frequency of 8%. This is a prospective clinical trial that may provide information on a safe and effective novel method for the treatment of DN, especially for patients with macroproteinuria. Ethics and Dissemination . The protocol is approved by the ethics committee of Beijing Hospital (2016BJYYEC-059-02). The results will be disseminated through peer-reviewed publications and international conferences. This trial is registered with ChiCTR-IOR-17010623.",2020,The primary endpoint is 24 h proteinuria decreased level (reduction of 30% vs. baseline) after 48 weeks of treatment.,"['patients with DN', 'Stage IV Diabetic Nephropathy', 'patients with stage 4 (Mogensen classification) diabetic CKD', 'Seventy participants diagnosed with DN', 'patients with macroproteinuria']","['valsartan', 'Tripterygium wilfordii Hook F Treatment', 'angiotensin receptor blocker (ARB) combined with TwHF and (2) ARB-only']","['serum creatinine', '24\u2009h proteinuria decreased level', 'cause and cardiovascular-related mortality, (2) development of ESRD (serum\u2009creatinine > 530.4\u2009 μ mol/L or estimated glomerular filtration rate (eGFR', 'adverse event (AE) frequency']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011881', 'cui_str': 'Kidney disorder due to diabetes mellitus'}, {'cui': 'C0441772', 'cui_str': 'Stage level 4'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0216784', 'cui_str': 'valsartan'}, {'cui': 'C0077273', 'cui_str': 'Leigong Teng'}, {'cui': 'C0181209', 'cui_str': 'Hook'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0034787', 'cui_str': 'Angiotensin receptor'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0521942', 'cui_str': 'Angiotensin II receptor antagonist'}]","[{'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum'}, {'cui': 'C0033687', 'cui_str': 'Proteinuria'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0022661', 'cui_str': 'Chronic renal failure'}, {'cui': 'C0347982', 'cui_str': 'mol/L'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}]",70.0,0.12708,The primary endpoint is 24 h proteinuria decreased level (reduction of 30% vs. baseline) after 48 weeks of treatment.,"[{'ForeName': 'Xu', 'Initials': 'X', 'LastName': 'Lengnan', 'Affiliation': 'Department of Nephrology, Beijing Hospital, National Center of Gerontology, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, China.'}, {'ForeName': 'Zhao', 'Initials': 'Z', 'LastName': 'Ban', 'Affiliation': 'Department of Nephrology, Beijing Hospital, National Center of Gerontology, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, China.'}, {'ForeName': 'Wang', 'Initials': 'W', 'LastName': 'Haitao', 'Affiliation': 'Department of Nephrology, Beijing Hospital, National Center of Gerontology, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, China.'}, {'ForeName': 'Liu', 'Initials': 'L', 'LastName': 'Lili', 'Affiliation': 'Department of Nephrology, Beijing Hospital, National Center of Gerontology, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, China.'}, {'ForeName': 'Chen', 'Initials': 'C', 'LastName': 'Aiqun', 'Affiliation': 'Department of Nephrology, Beijing Hospital, National Center of Gerontology, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, China.'}, {'ForeName': 'Wang', 'Initials': 'W', 'LastName': 'Huan', 'Affiliation': 'Department of Nephrology, Beijing Hospital, National Center of Gerontology, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, China.'}, {'ForeName': 'Zeng', 'Initials': 'Z', 'LastName': 'Ping', 'Affiliation': 'The MOH Key Laboratory of Geriatrics, Beijing Hospital, National Center of Gerontology, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, China.'}, {'ForeName': 'Mao', 'Initials': 'M', 'LastName': 'Yonghui', 'Affiliation': 'Department of Nephrology, Beijing Hospital, National Center of Gerontology, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, China.'}]",BioMed research international,['10.1155/2020/9181037'] 2348,32596692,The association between comorbidity and physical activity levels in people with osteoarthritis: Secondary analysis from two randomised controlled trials.,"Objective To determine whether comorbidity presence, frequency or type is associated with Physical Activity (PA) levels in people with Osteoarthritis (OA). Design Secondary data analysis of adults aged ≥45, with OA related pain recruited to the BEEP trial (knee pain, n = 514) (ISRCTN93634563) and the MOSAICS trial (peripheral joint pain, n = 525) (ISRCTN06984617). Comorbidities considered were respiratory, cardiovascular diseases (CVD), depression, type 2 diabetes and obesity. Self-report PA was measured using the Physical Activity Scale for the Elderly (PASE). Linear regression models were used to estimate the mean change (β) in PA with comorbidity presence, frequency and type adjusting for potential confounding covariates. Results In the BEEP trial comorbidity presence was associated with a decrease in PASE score (β = -32.25 [95% confidence interval (95% CI) -48.57, -15.93]). Each additional comorbidity was associated with an incrementally lower PASE score, one comorbidity (β = -24.42 [-42.45, -6.38]), two comorbidities β = -34.76 [-56.05, -13.48]), and three or more comorbidities β = -73.71 [-106.84, -40.58]) compared to those with no comorbidity. This pattern was similar in MOSAICS, but with a plateau in association from two comorbidities onward. In BEEP and MOSAICS, respiratory (β = -40.60 [-60.50, -20.35]; β = -11.82 [-34.95, 11.31]) and CVD (β = -27.15 [-53.25, -1.05]; β = -30.84 [-51.89, -9.80]) comorbidities were associated with the largest reduction in PASE scores respectively. Conclusion Comorbidity presence and frequency is associated with lower PA levels and respiratory and CVD comorbidities have the greatest impact. Future exploratory work needs to be done to understand how and why comorbidity is associated with PA levels in people with OA.",2020,"Each additional comorbidity was associated with an incrementally lower PASE score, one comorbidity (β = -24.42 [-42.45, -6.38]), two comorbidities β ","['people with OA', 'adults aged ≥45, with OA related pain recruited to the BEEP trial (knee pain, n = 514', 'people with osteoarthritis', 'people with Osteoarthritis (OA']",[],"['respiratory, cardiovascular diseases (CVD), depression, type 2 diabetes and obesity', 'Physical Activity (PA) levels', 'comorbidity and physical activity levels', 'PASE score (β\xa0', 'Physical Activity Scale']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0231749', 'cui_str': 'Knee pain'}]",[],"[{'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",525.0,0.166141,"Each additional comorbidity was associated with an incrementally lower PASE score, one comorbidity (β = -24.42 [-42.45, -6.38]), two comorbidities β ","[{'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'McKevitt', 'Affiliation': 'School of Primary, Community and Social Care, Primary Care Centre Versus Arthritis, Keele University, Keele, ST5 5BG, UK.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Healey', 'Affiliation': 'School of Primary, Community and Social Care, Primary Care Centre Versus Arthritis, Keele University, Keele, ST5 5BG, UK.'}, {'ForeName': 'Clare', 'Initials': 'C', 'LastName': 'Jinks', 'Affiliation': 'School of Primary, Community and Social Care, Primary Care Centre Versus Arthritis, Keele University, Keele, ST5 5BG, UK.'}, {'ForeName': 'Trishna', 'Initials': 'T', 'LastName': 'Rathod-Mistry', 'Affiliation': 'School of Primary, Community and Social Care, Primary Care Centre Versus Arthritis, Keele University, Keele, ST5 5BG, UK.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Quicke', 'Affiliation': 'School of Primary, Community and Social Care, Primary Care Centre Versus Arthritis, Keele University, Keele, ST5 5BG, UK.'}]",Osteoarthritis and cartilage open,['10.1016/j.ocarto.2020.100057'] 2349,32602148,Antacid monotherapy is more effective in relieving epigastric pain than in combination with lidocaine. A randomized double-blind clinical trial.,"This was a double-blind, randomized clinical trial comparing three different solutions for the treatment of adults with epigastric pain or dyspepsia presenting to the emergency department (ED). It was conducted in the Royal Melbourne Hospital, a tertiary, adult-only, inner-city center in Melbourne with 75,000 annual ED visits. Data were collected over three months, from June to August 2019, between 0800 and 2300, seven days a week.",2020,"This was a double-blind, randomized clinical trial comparing three different solutions for the treatment of adults with epigastric pain or dyspepsia presenting to the emergency department (ED).","['Royal Melbourne Hospital, a tertiary, adult-only, inner-city center in Melbourne with 75,000 annual ED visits', 'adults with epigastric pain or dyspepsia presenting to the emergency department (ED']","['Antacid monotherapy', 'lidocaine']",['epigastric pain'],"[{'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0557849', 'cui_str': 'Inner city'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0586082', 'cui_str': 'Emergency department patient visit'}, {'cui': 'C0232493', 'cui_str': 'Epigastric pain'}, {'cui': 'C0013395', 'cui_str': 'Indigestion'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}]","[{'cui': 'C0003138', 'cui_str': 'Antacid'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}]","[{'cui': 'C0232493', 'cui_str': 'Epigastric pain'}]",,0.679809,"This was a double-blind, randomized clinical trial comparing three different solutions for the treatment of adults with epigastric pain or dyspepsia presenting to the emergency department (ED).","[{'ForeName': 'Jaimee', 'Initials': 'J', 'LastName': 'Warren', 'Affiliation': 'Emergency Department, Royal Melbourne Hospital, Melbourne, Australia.'}, {'ForeName': 'Blake', 'Initials': 'B', 'LastName': 'Cooper', 'Affiliation': 'Emergency Department, Royal Melbourne Hospital, Melbourne, Australia.'}, {'ForeName': 'Anton', 'Initials': 'A', 'LastName': 'Jermakoff', 'Affiliation': 'Emergency Department, Royal Melbourne Hospital, Melbourne, Australia.'}, {'ForeName': 'Jonathan C', 'Initials': 'JC', 'LastName': 'Knott', 'Affiliation': 'Emergency Department, Royal Melbourne Hospital, Melbourne, Australia.'}]",Academic emergency medicine : official journal of the Society for Academic Emergency Medicine,['10.1111/acem.14069'] 2350,32602162,Convergent cross-sectional and longitudinal evidence for gaming-cue specific posterior parietal dysregulations in early stages of internet gaming disorder.,"Exaggerated reactivity to drug-cues and emotional dysregulations represent key symptoms of early stages of substance use disorders. The diagnostic criteria for (Internet) gaming disorder strongly resemble symptoms for substance-related addictions. However, previous cross-sections studies revealed inconsistent results with respect to neural cue reactivity and emotional dysregulations in these populations. To this end, the present fMRI study applied a combined cross-sectional and longitudinal design in regular online gamers (n = 37) and gaming-naïve controls (n = 67). To separate gaming-associated changes from predisposing factors, gaming-naive subjects were randomly assigned to 6 weeks of daily Internet gaming or a non-gaming condition. At baseline and after the training, subjects underwent an fMRI paradigm presenting gaming-related cues and non-gaming-related emotional stimuli. Cross-sectional comparisons revealed gaming-cue specific enhanced valence attribution and neural reactivity in a parietal network, including the posterior cingulate in regular gamers as compared to gaming naïve-controls. Longitudinal analysis revealed that 6 weeks of gaming elevated valence ratings as well as neural cue-reactivity in a similar parietal network, specifically the posterior cingulate in previously gaming-naïve controls. Together, the longitudinal design did not reveal supporting evidence for altered emotional processing of non-gaming associated stimuli in regular gamers whereas convergent evidence for increased emotional and neural reactivity to gaming-associated stimuli was observed. Findings suggest that exaggerated neural reactivity in posterior parietal regions engaged in default mode and automated information processing already occur during early stages of regular gaming and probably promote continued engagement in gaming behavior.",2020,"Longitudinal analysis revealed that 6 weeks of gaming elevated valence ratings as well as neural cue-reactivity in a similar parietal network, specifically the posterior cingulate in previously gaming-naïve controls.",['regular online gamers (n = 37) and gaming-naïve controls (n = 67'],"['daily Internet gaming or a non-gaming condition', 'fMRI paradigm presenting gaming-related cues and non-gaming-related emotional stimuli']",[],"[{'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}]",[],67.0,0.0398672,"Longitudinal analysis revealed that 6 weeks of gaming elevated valence ratings as well as neural cue-reactivity in a similar parietal network, specifically the posterior cingulate in previously gaming-naïve controls.","[{'ForeName': 'Fangwen', 'Initials': 'F', 'LastName': 'Yu', 'Affiliation': 'The Clinical Hospital of the Chengdu Brain Science Institute, Key Laboratory for NeuroInformation, University of Electronic Science and Technology of China, Chengdu, China.'}, {'ForeName': 'Rayna', 'Initials': 'R', 'LastName': 'Sariyska', 'Affiliation': 'Institute of Psychology and Education, Ulm University, Ulm, Baden-Württemberg, Germany.'}, {'ForeName': 'Bernd', 'Initials': 'B', 'LastName': 'Lachmann', 'Affiliation': 'Institute of Psychology and Education, Ulm University, Ulm, Baden-Württemberg, Germany.'}, {'ForeName': 'Qianqian', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': 'The Clinical Hospital of the Chengdu Brain Science Institute, Key Laboratory for NeuroInformation, University of Electronic Science and Technology of China, Chengdu, China.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Reuter', 'Affiliation': 'Department of Psychology, University of Bonn, Bonn, North Rhine-Westphalia, Germany.'}, {'ForeName': 'Bernd', 'Initials': 'B', 'LastName': 'Weber', 'Affiliation': 'Center for Economics and Neuroscience, University of Bonn, Bonn, North Rhine-Westphalia, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Trautner', 'Affiliation': 'Center for Economics and Neuroscience, University of Bonn, Bonn, North Rhine-Westphalia, Germany.'}, {'ForeName': 'Shuxia', 'Initials': 'S', 'LastName': 'Yao', 'Affiliation': 'The Clinical Hospital of the Chengdu Brain Science Institute, Key Laboratory for NeuroInformation, University of Electronic Science and Technology of China, Chengdu, China.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Montag', 'Affiliation': 'The Clinical Hospital of the Chengdu Brain Science Institute, Key Laboratory for NeuroInformation, University of Electronic Science and Technology of China, Chengdu, China.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Becker', 'Affiliation': 'The Clinical Hospital of the Chengdu Brain Science Institute, Key Laboratory for NeuroInformation, University of Electronic Science and Technology of China, Chengdu, China.'}]",Addiction biology,['10.1111/adb.12933'] 2351,32298279,Anxiety: An overlooked confounder in the characterisation of chronic stress-related conditions?,"Although anxiety disorders are among the most prevalent of psychiatric disorders, childhood trauma-related studies seldom consider anxiety proneness as distinct aetiological contributor. We aimed to distinguish between trauma- and anxiety-associated physiological profiles. South African adolescent volunteers were categorised for trauma exposure (CTQ, mean score 39±11) and anxiety proneness (AP)(CASI, mean score 37±7, STAI-T, mean score 41±8). Circulating hormone and leukocyte glucocorticoid receptor levels, as well as leukocyte functional capacity, were assessed. AP was associated with lower DHEAs (P<0.05) and higher leukocyte GR expression (P<0.05). DHEAs was also negatively correlated with anxiety sensitivity (CASI, P<0.05). In conclusion, AP may have more predictive power than trauma in terms of health profile. Increased glucocorticoid sensitivity previously reported after trauma, may be a unique function of anxiety and not trauma exposure per se. DHEAs concentration was identified as potentially useful marker for monitoring progressive changes in HPA-axis sensitivity and correlated with psychological measures of anxiety.",2020,AP was associated with lower DHEAs (P<0.05) and higher leukocyte GR expression (P<0.05).,['South African adolescent volunteers'],[],"['Circulating hormone and leukocyte glucocorticoid receptor levels', 'leukocyte GR expression', 'anxiety sensitivity', 'Anxiety']","[{'cui': 'C0027567', 'cui_str': 'African race'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}]",[],"[{'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}, {'cui': 'C0034809', 'cui_str': 'Glucocorticoid receptor'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}]",,0.0172085,AP was associated with lower DHEAs (P<0.05) and higher leukocyte GR expression (P<0.05).,"[{'ForeName': 'Monet', 'Initials': 'M', 'LastName': 'Viljoen', 'Affiliation': 'Department of Physiological Sciences, Science Faculty, Stellenbosch University, Stellenbosch, South Africa.'}, {'ForeName': 'Rohan M', 'Initials': 'RM', 'LastName': 'Benecke', 'Affiliation': 'Department of Physiological Sciences, Science Faculty, Stellenbosch University, Stellenbosch, South Africa.'}, {'ForeName': 'Lindi', 'Initials': 'L', 'LastName': 'Martin', 'Affiliation': 'Department of Psychiatry, Faculty of Health Sciences, Stellenbosch University, Bellville, Cape Town, South Africa.'}, {'ForeName': 'Rozanne C M', 'Initials': 'RCM', 'LastName': 'Adams', 'Affiliation': 'Department of Physiological Sciences, Science Faculty, Stellenbosch University, Stellenbosch, South Africa.'}, {'ForeName': 'Soraya', 'Initials': 'S', 'LastName': 'Seedat', 'Affiliation': 'Department of Psychiatry, Faculty of Health Sciences, Stellenbosch University, Bellville, Cape Town, South Africa.'}, {'ForeName': 'Carine', 'Initials': 'C', 'LastName': 'Smith', 'Affiliation': 'Department of Physiological Sciences, Science Faculty, Stellenbosch University, Stellenbosch, South Africa.'}]",PloS one,['10.1371/journal.pone.0230053'] 2352,31499155,Ingenol mebutate gel for the treatment of molluscum contagiosum: An open-label comparative pilot study.,,2020,,[],['Ingenol mebutate gel'],[],[],"[{'cui': 'C2825682', 'cui_str': 'ingenol mebutate'}, {'cui': 'C0017243', 'cui_str': 'Gel'}]",[],,0.0126807,,"[{'ForeName': 'Kihyuk', 'Initials': 'K', 'LastName': 'Shin', 'Affiliation': 'Department of Dermatology, School of Medicine, Pusan National University, Busan, Korea; Department of Dermatology, Pusan National University Yangsan Hospital, Yangsan, Korea; Research Institute for Convergence of Biomedical Science and Technology, Yangsan, Korea; Biomedical Research Institute, Pusan National University Hospital, Korea.'}, {'ForeName': 'Kyung-Nam', 'Initials': 'KN', 'LastName': 'Bae', 'Affiliation': 'Department of Dermatology, School of Medicine, Pusan National University, Busan, Korea.'}, {'ForeName': 'Hoon-Soo', 'Initials': 'HS', 'LastName': 'Kim', 'Affiliation': 'Department of Dermatology, School of Medicine, Pusan National University, Busan, Korea.'}, {'ForeName': 'Byung-Soo', 'Initials': 'BS', 'LastName': 'Kim', 'Affiliation': 'Department of Dermatology, School of Medicine, Pusan National University, Busan, Korea.'}, {'ForeName': 'Moon-Bum', 'Initials': 'MB', 'LastName': 'Kim', 'Affiliation': 'Department of Dermatology, School of Medicine, Pusan National University, Busan, Korea.'}, {'ForeName': 'Hyun-Chang', 'Initials': 'HC', 'LastName': 'Ko', 'Affiliation': 'Department of Dermatology, School of Medicine, Pusan National University, Busan, Korea; Department of Dermatology, Pusan National University Yangsan Hospital, Yangsan, Korea; Research Institute for Convergence of Biomedical Science and Technology, Yangsan, Korea. Electronic address: hcko@pusan.ac.kr.'}]",Journal of the American Academy of Dermatology,['10.1016/j.jaad.2019.08.081'] 2353,31560382,Alcohol Consumption and Risk of Dementia and Cognitive Decline Among Older Adults With or Without Mild Cognitive Impairment.,"Importance Substantial heterogeneity and uncertainty exist in the observed associations between alcohol consumption and dementia. Objective To assess the association between alcohol consumption and dementia and the roles of mild cognitive impairment (MCI) and apolipoprotein E ε4 (APOE E4) genotype in modifying this association. Design, Setting, and Participants This cohort study used data from the Ginkgo Evaluation of Memory Study, conducted from 2000 to 2008 among US community-dwelling participants. This study analyzed 3021 participants aged 72 years and older who were free of dementia. Data analysis was performed from 2017 to 2018. Exposures Self-reported alcohol consumption, drinking frequency, and quantity. Main Outcomes and Measures Using multivariable proportional hazards regression and linear mixed models, the risk of dementia and the rate of change over time in the Modified Mini-Mental State Examination were estimated. Results Among 3021 participants, the median (interquartile range) age was 78 (76-80) years; 1395 (46.2%) were female. During a median (interquartile range) follow-up of 6.0 (4.9-6.5) years, 512 cases of dementia occurred. For 7.1 to 14.0 drinks per week compared with less than 1.0 drink per week, the hazard ratios for dementia were 0.63 (95% CI, 0.38-1.06) among 2548 participants without MCI and 0.93 (95% CI, 0.47-1.84) among 473 participants with MCI. Among participants with MCI, the hazard ratio for dementia was 1.72 (95% CI, 0.87-3.40) for more than 14.0 drinks per week compared with less than 1.0 drink per week. The association of alcohol intake with dementia differed for participants with and without baseline MCI (P for interaction = .03). Among participants without MCI, daily low-quantity drinking was associated with lower dementia risk than infrequent higher-quantity drinking (hazard ratio, 0.45; 95% CI, 0.23-0.89; P = .02). Findings were consistent when stratified by sex, age, and APOE E4 genotype. Compared with drinking less than 1.0 drink per week, complete abstention (in participants without MCI) and the consumption of more than 14.0 drinks per week (in participants with MCI) were associated with lower Modified Mini-Mental State Examination scores (mean difference at follow-up compared with baseline, -0.46 point [95% CI, -0.87 to -0.04 point] and -3.51 points [95% CI, -5.75 to -1.27 points], respectively). Conclusions and Relevance In this study, complete abstention and consuming more than 14.0 drinks per week (compared with drinking <1.0 drink per week) were associated with lower cognitive scores among participants aged 72 years and older. Particular caution is needed among individuals with MCI who continue to drink alcohol.",2019,The association of alcohol intake with dementia differed for participants with and without baseline MCI (P for interaction = .03).,"['individuals with MCI who continue to drink alcohol', '3021 participants, the median (interquartile range) age was 78 (76-80) years; 1395 (46.2%) were female', 'Older Adults With or Without Mild Cognitive Impairment', '3021 participants aged 72 years and older who were free of dementia', '2000 to 2008 among US community-dwelling participants', 'participants aged 72 years and older']",[],"['lower cognitive scores', 'lower Modified Mini-Mental State Examination scores', 'hazard ratio for dementia', 'risk of dementia and the rate of change over time in the Modified Mini-Mental State Examination', 'hazard ratios for dementia', 'Alcohol Consumption and Risk of Dementia and Cognitive Decline', 'alcohol consumption, drinking frequency, and quantity']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1270972', 'cui_str': 'Mild cognitive disorder'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0470277', 'cui_str': '2000'}]",[],"[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C2960235', 'cui_str': 'Mini-mental state examination score'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0451306', 'cui_str': 'Mini-mental state examination'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0234985', 'cui_str': 'Mental Deterioration'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C1265611', 'cui_str': 'Quantity'}]",3021.0,0.0996753,The association of alcohol intake with dementia differed for participants with and without baseline MCI (P for interaction = .03).,"[{'ForeName': 'Manja', 'Initials': 'M', 'LastName': 'Koch', 'Affiliation': 'Department of Nutrition, Harvard T.H. Chan School of Public Health, Boston, Massachusetts.'}, {'ForeName': 'Annette L', 'Initials': 'AL', 'LastName': 'Fitzpatrick', 'Affiliation': 'Department of Family Medicine, University of Washington, Seattle.'}, {'ForeName': 'Stephen R', 'Initials': 'SR', 'LastName': 'Rapp', 'Affiliation': 'Department of Psychiatry and Behavioral Medicine, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Richard L', 'Initials': 'RL', 'LastName': 'Nahin', 'Affiliation': 'National Center for Complementary and Integrative Health, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Jeff D', 'Initials': 'JD', 'LastName': 'Williamson', 'Affiliation': 'Department of Internal Medicine, Wake Forest School of Medicine, Winston-Salem, North Carolina.'}, {'ForeName': 'Oscar L', 'Initials': 'OL', 'LastName': 'Lopez', 'Affiliation': 'Department of Neurology, School of Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Steven T', 'Initials': 'ST', 'LastName': 'DeKosky', 'Affiliation': 'Department of Neurology, University of Florida, Gainesville.'}, {'ForeName': 'Lewis H', 'Initials': 'LH', 'LastName': 'Kuller', 'Affiliation': 'Department of Epidemiology, Graduate School of Public Health, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Rachel H', 'Initials': 'RH', 'LastName': 'Mackey', 'Affiliation': 'Department of Neurology, School of Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Kenneth J', 'Initials': 'KJ', 'LastName': 'Mukamal', 'Affiliation': 'Department of Nutrition, Harvard T.H. Chan School of Public Health, Boston, Massachusetts.'}, {'ForeName': 'Majken K', 'Initials': 'MK', 'LastName': 'Jensen', 'Affiliation': 'Department of Nutrition, Harvard T.H. Chan School of Public Health, Boston, Massachusetts.'}, {'ForeName': 'Kaycee M', 'Initials': 'KM', 'LastName': 'Sink', 'Affiliation': 'Genentech, South San Francisco, California.'}]",JAMA network open,['10.1001/jamanetworkopen.2019.10319'] 2354,31734605,Comprehensive analysis of colorectal cancer-risk loci and survival outcome: A prognostic role for CDH1 variants.,"PURPOSE Genome-wide association studies have identified common single nucleotide polymorphisms (SNPs) at 83 loci associated with colorectal cancer (CRC) risk in European populations. Because germline variation can also influence patient outcome, we studied the relationship between these SNPs and CRC survivorship. EXPERIMENTAL DESIGN For the 83 risk loci, 10 lead SNPs were directly genotyped, 72 were imputed and 1 was not genotyped nor imputed, in 1948 unrelated patients with advanced CRC from the clinical trials COIN and COIN-B (oxaliplatin and fluoropyrimidine chemotherapy ± cetuximab). A Cox survival model was used for each variant, and variants classified by pathway, adjusting for known prognostic factors. We imposed a Bonferroni threshold of P = 6.6 × 10 -4 for multiple testing. We carried out meta-analyses of published risk SNPs associated with survival. RESULTS Univariate analysis identified six SNPs associated with overall survival (OS) (P < 0.05); however, only rs9939049 in CDH1 remained significant beyond the Bonferroni threshold (Hazard Ratio [HR] 1.44, 95% Confidence Intervals [CI]: 1.21-1.71, P = 5.0 × 10 -5 ). Fine mapping showed that rs12597188 was the most significant SNP at this locus and remained significant after adjustment for known prognostic factors beyond multiple testing thresholds (HR 1.23, 95% CI: 1.13-1.34, P = 1.9 × 10 -6 ). rs12597188 was also associated with poor response to therapy (OR 0.61, 95% CI: 0.42-0.87, P = 6.6 × 10 -3 ). No combinations of SNPs within pathways were more significantly associated with survival compared with single variants alone, and no other risk SNPs were associated with survival in meta-analyses. CONCLUSIONS The CRC susceptibility SNP rs9939049 in CDH1 influences patient survival and warrants further evaluation as a prognostic biomarker.",2020,"rs12597188 was also associated with poor response to therapy (OR 0.61, 95% CI: 0.42-0.87, P = ","['For the 83 risk loci', '1948 unrelated patients with advanced CRC from the clinical trials COIN and']",['COIN-B (oxaliplatin and fluoropyrimidine chemotherapy\xa0±\xa0cetuximab'],"['overall survival (OS', 'survival', 'colorectal cancer-risk loci and survival outcome']","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0445356', 'cui_str': 'Unrelated'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0524669', 'cui_str': 'Coins'}]","[{'cui': 'C0524669', 'cui_str': 'Coins'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0995188', 'cui_str': 'cetuximab'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.0403831,"rs12597188 was also associated with poor response to therapy (OR 0.61, 95% CI: 0.42-0.87, P = ","[{'ForeName': 'Matthew G', 'Initials': 'MG', 'LastName': 'Summers', 'Affiliation': 'Division of Cancer and Genetics, School of Medicine, Cardiff University, Heath Park, Cardiff, CF14 4XN, UK.'}, {'ForeName': 'Timothy S', 'Initials': 'TS', 'LastName': 'Maughan', 'Affiliation': 'CRUK/MRC Oxford Institute for Radiation Oncology, University of Oxford, Roosevelt Drive, Oxford OX3 7DQ, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Kaplan', 'Affiliation': 'MRC Clinical Trials Unit, Aviation House, 125 Kingsway, London, WC2B 6NH, UK.'}, {'ForeName': 'Philip J', 'Initials': 'PJ', 'LastName': 'Law', 'Affiliation': 'Division of Genetics and Epidemiology, The Institute of Cancer Research, London, SW7 3RP, UK.'}, {'ForeName': 'Richard S', 'Initials': 'RS', 'LastName': 'Houlston', 'Affiliation': 'Division of Genetics and Epidemiology, The Institute of Cancer Research, London, SW7 3RP, UK.'}, {'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Escott-Price', 'Affiliation': 'Institute of Psychological Medicine and Clinical Neurosciences, School of Medicine, Cardiff University, Hadyn Ellis Building, Maindy Road, Cardiff, CF24 4HQ, UK.'}, {'ForeName': 'Jeremy P', 'Initials': 'JP', 'LastName': 'Cheadle', 'Affiliation': 'Division of Cancer and Genetics, School of Medicine, Cardiff University, Heath Park, Cardiff, CF14 4XN, UK. Electronic address: cheadlejp@cardiff.ac.uk.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2019.09.024'] 2355,32600327,Experimental pain and fatigue induced by excessive chewing.,"BACKGROUND The study was aiming to optimize excessive gum chewing as an experimental model to induce jaw muscle pain and fatigue similar to those in painful TMDs with durations that would allow immediate investigations of jaw-motor function. Further, if any sex differences would be detected in the expression of pain. METHODS This randomized, double blinded study included 31 healthy participants of both sexes. A standardized chewing protocol of either 40- or 60-min of chewing was used with a wash-out period of 1 week. Subjective fatigue, pain characteristics and functional measures were assessed. For statistical analyses, Wilcoxon Signed Rank test, Mann-Whitney Rank Sum test and Friedman's ANOVA with Tukey post-hoc test were used. RESULTS High subjective fatigue scores that lasted up to 20 min after the end of the trial were significantly induced both in the 40- and 60-min chewing trials (P <  0.001*). Significant but mild pain was induced only in the 60-min trial (P = 0.004*) and only in men (P = 0.04*). Also, the induced pain area was significantly bigger in the 60-min trial (P = 0.009*). However, this increase in pain and pain area did not last to the first 10-min follow-up. There were no significant differences neither between the 40- and 60-min chewing trials, except regarding the pain area (P = 0.008*), nor between the sexes. CONCLUSION Taken together, excessive chewing in its current form does not seem to be a proper pain experimental model. The model needs further adjustments in order to mimic TMD-pain especially in women and to prolong the pain duration.",2020,"There were no significant differences neither between the 40- and 60-min chewing trials, except regarding the pain area (P = 0.008*), nor between the sexes. ",['31 healthy participants of both sexes'],[],"['pain and pain area', 'Subjective fatigue, pain characteristics and functional measures', 'subjective fatigue scores', 'induced pain area', 'Experimental pain and fatigue', 'expression of pain', 'pain area', 'mild pain']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}]",[],"[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C1286315', 'cui_str': 'Characteristic of pain'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0278138', 'cui_str': 'Mild pain'}]",31.0,0.0680313,"There were no significant differences neither between the 40- and 60-min chewing trials, except regarding the pain area (P = 0.008*), nor between the sexes. ","[{'ForeName': 'Samaa', 'Initials': 'S', 'LastName': 'Al Sayegh', 'Affiliation': 'Division of Oral Diagnostics and Rehabilitation, Department of Dental Medicine, Karolinska Institutet, Box 4046, SE-141 04, Huddinge, Sweden. samaa.al.sayegh@ki.se.'}, {'ForeName': 'Ioanna', 'Initials': 'I', 'LastName': 'Vasilatou', 'Affiliation': 'Division of Oral Diagnostics and Rehabilitation, Department of Dental Medicine, Karolinska Institutet, Box 4046, SE-141 04, Huddinge, Sweden.'}, {'ForeName': 'Abhishek', 'Initials': 'A', 'LastName': 'Kumar', 'Affiliation': 'Division of Oral Diagnostics and Rehabilitation, Department of Dental Medicine, Karolinska Institutet, Box 4046, SE-141 04, Huddinge, Sweden.'}, {'ForeName': 'Ceva', 'Initials': 'C', 'LastName': 'Al Barwari', 'Affiliation': 'Division of Oral Diagnostics and Rehabilitation, Department of Dental Medicine, Karolinska Institutet, Box 4046, SE-141 04, Huddinge, Sweden.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Fredriksson', 'Affiliation': 'Department of Clinical Oral Physiology at the Eastman Institute, Folktandvården Stockholms län AB, SE-113 24, Stockholm, Sweden.'}, {'ForeName': 'Anastasios', 'Initials': 'A', 'LastName': 'Grigoriadis', 'Affiliation': 'Division of Oral Diagnostics and Rehabilitation, Department of Dental Medicine, Karolinska Institutet, Box 4046, SE-141 04, Huddinge, Sweden.'}, {'ForeName': 'Nikolaos', 'Initials': 'N', 'LastName': 'Christidis', 'Affiliation': 'Division of Oral Diagnostics and Rehabilitation, Department of Dental Medicine, Karolinska Institutet, Box 4046, SE-141 04, Huddinge, Sweden.'}]",BMC oral health,['10.1186/s12903-020-01161-z'] 2356,32600336,Evolution of left ventricular function among subjects with ST-elevation myocardial infarction after percutaneous coronary intervention.,"BACKGROUND Atrioventricular plane displacement (AVPD) reflects longitudinal left ventricular (LV) systolic function, and wall thickening (WT) regional radial LV function. The temporal evolution of these measures after STEMI with CMR has not been evaluated. We aimed to investigate how AVPD and WT are affected globally and regionally from the sub-acute to the chronic phase after ST-elevation myocardial infarction (STEMI). METHODS Healthy volunteers without cardiovascular disease and medication (controls, n = 20) and patients from the CHILL-MI study ( NCT01379261 ) prospectively underwent magnetic resonance imaging (MRI) 2-6 days and 6 months after STEMI (n = 77). CHILL-MI randomized STEMI-patients to cooling therapy initiated before reperfusion or standard of care. AVPD was measured at six points in three long axis cine images and wall thickening in short axis cine images. Infarction was quantified using late gadolinium enhancement (LGE) and used to define infarct and remote segments. RESULTS There were no difference in AVPD either at acute or chronic phase (p = 0.90 and p = 0.40) or WT (p = 0.85 and p = 0.99) between patients randomized to cooling therapy and standard of care. Therefore, the results are presented for the pooled cohort. Global AVPD was decreased in both the sub-acute (12 ± 2 mm, p < 0.001) and the chronic phase (13 ± 2 mm, p < 0.001) compared to controls (15 ± 2 mm) with a partial recovery of AVPD (p < 0.001) in the chronic phase. Patients with left anterior descending (LAD) and right coronary artery (RCA) infarcts had decreased AVPD in the chronic phase in both infarcted and remote segments. Mean WT was decreased in patients with LAD infarction both in the sub-acute and the chronic phase in both infarcted and remote segments. The decrease in WT in patients with RCA and left circumflex (LCx) infarcts was more affected in the infarcted segments, especially in the chronic phase. CONCLUSION AVPD was a global rather than regional marker of cardiac function in this STEMI study and this may explain the prognostic importance of local measurements of mitral annular plane systolic excursion (MAPSE). The decrease in WT in remote myocardium even in the chronic phase needs to be taken into consideration when combining functional measurements with infarct quantification for diagnosis of post-ischemic stunning and hibernation.",2020,"Global AVPD was decreased in both the sub-acute (12 ± 2 mm, p < 0.001) and the chronic phase (13 ± 2 mm, p < 0.001) compared to controls (15 ± 2 mm) with a partial recovery of AVPD (","['Patients with left anterior descending (LAD) and right coronary artery (RCA) infarcts', 'Healthy volunteers without cardiovascular disease and medication (controls, n\u2009=\u200920) and patients from the CHILL-MI study ( NCT01379261 ) prospectively underwent', 'subjects with ST-elevation myocardial infarction after percutaneous coronary intervention']",['magnetic resonance imaging (MRI) 2-6\u2009days and 6\u2009months after STEMI'],"['longitudinal left ventricular (LV) systolic function, and wall thickening (WT) regional radial LV function', 'Mean WT', 'AVPD', 'Global AVPD', 'AVPD either at acute or chronic phase', 'decrease in WT']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0441998', 'cui_str': 'Left anterior'}, {'cui': 'C1261316', 'cui_str': 'Right coronary artery structure'}, {'cui': 'C0021308', 'cui_str': 'Infarct'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0085593', 'cui_str': 'Chill'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1303258', 'cui_str': 'Acute ST segment elevation myocardial infarction'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}]","[{'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C1303258', 'cui_str': 'Acute ST segment elevation myocardial infarction'}]","[{'cui': 'C0205127', 'cui_str': 'Longitudinal'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0205380', 'cui_str': 'Walled'}, {'cui': 'C0205400', 'cui_str': 'Thickened'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0442038', 'cui_str': 'Radial'}, {'cui': 'C0080310', 'cui_str': 'Left ventricular function'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C0012725', 'cui_str': 'Displacement - mental defense mechanism'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0457343', 'cui_str': 'Chronic phase'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}]",,0.0454076,"Global AVPD was decreased in both the sub-acute (12 ± 2 mm, p < 0.001) and the chronic phase (13 ± 2 mm, p < 0.001) compared to controls (15 ± 2 mm) with a partial recovery of AVPD (","[{'ForeName': 'Ulrika', 'Initials': 'U', 'LastName': 'Pahlm', 'Affiliation': 'Clinical Physiology, Department of Clinical Sciences Lund, Lund University, Skane University Hospital, Lund, Sweden.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Ostenfeld', 'Affiliation': 'Clinical Physiology, Department of Clinical Sciences Lund, Lund University, Skane University Hospital, Lund, Sweden.'}, {'ForeName': 'Felicia', 'Initials': 'F', 'LastName': 'Seemann', 'Affiliation': 'Clinical Physiology, Department of Clinical Sciences Lund, Lund University, Skane University Hospital, Lund, Sweden.'}, {'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Engblom', 'Affiliation': 'Clinical Physiology, Department of Clinical Sciences Lund, Lund University, Skane University Hospital, Lund, Sweden.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Erlinge', 'Affiliation': 'Cardiology, Department of Clinical Sciences Lund, Lund University, Skane University Hospital, Lund, Sweden.'}, {'ForeName': 'Einar', 'Initials': 'E', 'LastName': 'Heiberg', 'Affiliation': 'Clinical Physiology, Department of Clinical Sciences Lund, Lund University, Skane University Hospital, Lund, Sweden.'}, {'ForeName': 'Håkan', 'Initials': 'H', 'LastName': 'Arheden', 'Affiliation': 'Clinical Physiology, Department of Clinical Sciences Lund, Lund University, Skane University Hospital, Lund, Sweden.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Carlsson', 'Affiliation': 'Clinical Physiology, Department of Clinical Sciences Lund, Lund University, Skane University Hospital, Lund, Sweden. marcus.carlsson@med.lu.se.'}]",BMC cardiovascular disorders,['10.1186/s12872-020-01540-y'] 2357,32600347,Effectiveness of a health education intervention on the use of long-lasting insecticidal nets for the prevention of malaria in pregnant women of Pakistan: a quasi-experimental study.,"BACKGROUND About one quarter of pregnant women in the population of Pakistan are using long-lasting insecticide-treated bed nets (LLINs) for prevention of malaria. Past research reported that adequate information and education would act as mediator to change behaviour among patients for prevention of malaria infection. The effective use of LLINs would contribute to reduction of disease burden caused by malaria. The aim of this study was to determine the effectiveness of health education on the adoption of LLINs among pregnant women living in Tharparkar, a remote district in Sindh Province, Pakistan. METHODS A quasi-experimental study design with control and intervention groups was conducted with 200 pregnant women (100 in each group). Women in the intervention group were provided with health education sessions on malaria for 12 weeks, while those in the control group obtained routine information from lady health workers (LHWs). Pre- and post-intervention assessment was done of knowledge about malaria and use of LLIN, which was statistically analysed using descriptive statistics and difference in difference (DID) multivariable regression analysis to test effectiveness of the intervention. RESULTS Baseline was conducted with 200 pregnant women. Demographic characteristics were similar in both groups with slight differences in age, education, income, type of latrine, and source of drinking water. There were no significant differences between mean knowledge and use of LLINs scores between groups at baseline. However, the estimated DID value after the intervention was 4.170 (p < 0.01) and represents an increase in scores of knowledge in the intervention group compared to control. Similarly DID value of 3.360 (p < 0.05) showed an increase in use of LLINs score after the intervention which was significant, showing that the intervention had a positive effect. CONCLUSIONS Results proved that health education could be an effective intervention for improving knowledge and usage of LLINs among pregnant women for the prevention of malaria. Such educational interventions have a positive potential to be implemented at larger scale by incorporating them into routine health sessions provided by health workers.",2020,"Similarly DID value of 3.360 (p < 0.05) showed an increase in use of LLINs score after the intervention which was significant, showing that the intervention had a positive effect. ","['pregnant women living in Tharparkar, a remote district in Sindh Province, Pakistan', 'pregnant women in the population of Pakistan', '200 pregnant women', '200 pregnant women (100 in each group', 'pregnant women of Pakistan']","['control group obtained routine information from lady health workers (LHWs', 'LLINs', 'health education', 'health education intervention', 'health education sessions']","['mean knowledge and use of LLINs scores', 'knowledge and usage of LLINs', 'Demographic characteristics', 'LLINs score', 'scores of knowledge']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0030211', 'cui_str': 'Pakistan'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C2717999', 'cui_str': 'Insecticide-Treated Bed Nets'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C2717999', 'cui_str': 'Insecticide-Treated Bed Nets'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0457083', 'cui_str': 'Usage'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}]",200.0,0.0438104,"Similarly DID value of 3.360 (p < 0.05) showed an increase in use of LLINs score after the intervention which was significant, showing that the intervention had a positive effect. ","[{'ForeName': 'Ramesh', 'Initials': 'R', 'LastName': 'Kumar', 'Affiliation': 'Health Services Academy, Ministry of National Health Services Regulation & Coordination, Government of Pakistan, Islamabad, Pakistan. drramesh1978@gmail.com.'}, {'ForeName': 'Midhat', 'Initials': 'M', 'LastName': 'Farzeen', 'Affiliation': 'Health Services Academy, Ministry of National Health Services Regulation & Coordination, Government of Pakistan, Islamabad, Pakistan.'}, {'ForeName': 'Assad', 'Initials': 'A', 'LastName': 'Hafeez', 'Affiliation': 'Health Services Academy, Ministry of National Health Services Regulation & Coordination, Government of Pakistan, Islamabad, Pakistan.'}, {'ForeName': 'Baseer Khan', 'Initials': 'BK', 'LastName': 'Achakzai', 'Affiliation': 'Directorate of Malaria, Ministry of National Health Services Regulation & Coordination, Government of Pakistan, Islamabad, Pakistan.'}, {'ForeName': 'Muskan', 'Initials': 'M', 'LastName': 'Vankwani', 'Affiliation': 'Dow international Medical College Karachi, Karachi, Pakistan.'}, {'ForeName': 'Manohar', 'Initials': 'M', 'LastName': 'Lal', 'Affiliation': 'Federal Government Polyclinic Postgraduate Institute, Islamabad, Pakistan.'}, {'ForeName': 'Rabia', 'Initials': 'R', 'LastName': 'Iqbal', 'Affiliation': 'Federal Government Polyclinic Postgraduate Institute, Islamabad, Pakistan.'}, {'ForeName': 'Ratana', 'Initials': 'R', 'LastName': 'Somrongthong', 'Affiliation': 'College of Public Health Sciences, Chulalongkorn University, Bangkok, Thailand. sratana3@chula.ac.th.'}]",Malaria journal,['10.1186/s12936-020-03298-2'] 2358,32600358,Effect of pneumoperitoneum pressure and the depth of neuromuscular block on renal function in patients with diabetes undergoing laparoscopic pelvic surgery: study protocol for a double-blinded 2 × 2 factorial randomized controlled trial.,"BACKGROUND Patients with diabetes mellitus are at a high risk of developing postoperative acute kidney injury. For patients receiving laparoscopic surgery, standard-pressure pneumoperitoneum (SPP) currently applied in clinical practice also undermines renal perfusion. Several studies have shown that low-pressure pneumoperitoneum (LPP) might reduce pressure-related ischemic renal injury. However, LPP may compromise the view of the surgical field. Previous studies have indicated that deep neuromuscular blockade (NMB) can ameliorate this issue. However, the conclusion is still uncertain. The hypothesis of this study is that the joint use of LPP and deep NMB can reduce perioperative renal injury in diabetic patients undergoing laparoscopic pelvic surgery without impeding the view of the surgical field. METHODS This is a double-blinded, randomized controlled trial using a 2 × 2 factorial trial design. A total of 648 diabetes patients scheduled for major laparoscopic pelvic surgeries at Peking Union Medical College Hospital will be randomized into the following four groups: SPP (12-15 mmHg) + deep-NMB (post-tetanic count of 1-2) group, LPP (7-10 mmHg) + deep-NMB group, SPP + moderate-NMB (train-of-four of 1-2) group, and LPP + moderate-NMB group. The primary outcome is serum cystatin C level measured before insufflation, after deflation, 24 h postoperatively, and 72 h postoperatively. The secondary outcomes are serum creatinine level, intraoperative urine output, erythrocytes in urinary sediment, renal tissue oxygen saturation, Leiden's surgical condition rating scale, surgery duration, and occurrence of bucking or body movement. DISCUSSION This study will provide evidence for the effect of LPP on renal function protection in patients with diabetes undergoing laparoscopic pelvic surgery. The trial can also help us to understand whether deep NMB can improve surgical conditions. TRIAL REGISTRATION ClinicalTrials.gov : NCT04259112 . Prospectively registered on 5 February 2020.",2020,Several studies have shown that low-pressure pneumoperitoneum (LPP) might reduce pressure-related ischemic renal injury.,"['648 diabetes patients scheduled for major laparoscopic pelvic surgeries at Peking Union Medical College Hospital', 'Patients with diabetes mellitus', 'diabetic patients undergoing laparoscopic pelvic surgery', 'patients with diabetes undergoing laparoscopic pelvic surgery']","['LPP', 'LPP and deep NMB', 'pneumoperitoneum pressure and the depth of neuromuscular block', 'laparoscopic surgery, standard-pressure pneumoperitoneum (SPP', 'SPP (12-15\u2009mmHg)\u2009+\u2009deep-NMB', 'low-pressure pneumoperitoneum (LPP', 'LPP (7-10\u2009mmHg)\u2009+\u2009deep-NMB group, SPP\u2009+\u2009moderate-NMB (train-of-four of 1-2) group, and LPP\u2009+\u2009moderate-NMB group']","['renal function protection', ""serum creatinine level, intraoperative urine output, erythrocytes in urinary sediment, renal tissue oxygen saturation, Leiden's surgical condition rating scale, surgery duration, and occurrence of bucking or body movement"", 'renal function', 'serum cystatin C level measured before insufflation, after deflation, 24\u2009h postoperatively, and 72\u2009h postoperatively']","[{'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0030797', 'cui_str': 'Pelvic'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0032320', 'cui_str': 'Pneumoperitoneum'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0234119', 'cui_str': 'Neuromuscular blockade'}, {'cui': 'C0235062', 'cui_str': 'Induction of neuromuscular blockade'}, {'cui': 'C0751429', 'cui_str': 'Laparoscopic surgery'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0439475', 'cui_str': 'mmHg'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}]","[{'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0232856', 'cui_str': 'Rate of urine output, function'}, {'cui': 'C1261248', 'cui_str': 'Urine sediment'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0852885', 'cui_str': 'Bucking'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0071744', 'cui_str': 'Cystatin C'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0021634', 'cui_str': 'Insufflation'}]",,0.486298,Several studies have shown that low-pressure pneumoperitoneum (LPP) might reduce pressure-related ischemic renal injury.,"[{'ForeName': 'Xiaohan', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': 'Department of Anesthesiology, Chinese Academy of Medical Sciences & Peking Union Medical College Hospital, Beijing, 100730, China.'}, {'ForeName': 'Yahong', 'Initials': 'Y', 'LastName': 'Gong', 'Affiliation': 'Department of Anesthesiology, Chinese Academy of Medical Sciences & Peking Union Medical College Hospital, Beijing, 100730, China. yh2087@163.com.'}, {'ForeName': 'Yuelun', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Medical Research Center, Chinese Academy of Medical Sciences & Peking Union Medical College Hospital, Beijing, 100730, China.'}, {'ForeName': 'Jiaxin', 'Initials': 'J', 'LastName': 'Lang', 'Affiliation': 'Department of Anesthesiology, Chinese Academy of Medical Sciences & Peking Union Medical College Hospital, Beijing, 100730, China.'}, {'ForeName': 'Yuguang', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': 'Department of Anesthesiology, Chinese Academy of Medical Sciences & Peking Union Medical College Hospital, Beijing, 100730, China.'}]",Trials,['10.1186/s13063-020-04477-x'] 2359,31688620,Inpatient Ordering of Home Hydroxyurea by Residents for Hospitalized Patients With Sickle Cell Disease.,"BACKGROUND Hydroxyurea is a well-established disease-modifying medication for sickle cell disease (SCD). At some institutions, hydroxyurea can only be ordered by ""chemotherapy-certified"" providers which may not include pediatric resident physicians. METHODS We conducted a survey of 39 American pediatric hospitals regarding their policy on resident hydroxyurea ordering for SCD. Our institution changed its policy in June 2016 to allow residents to order hydroxyurea for hospitalized patients with SCD who were already on hydroxyurea at home. We conducted a retrospective review of the medical records of a random sample of patients with SCD on hydroxyurea admitted the year before and the year after this policy change. RESULTS In our national survey, 51% of surveyed hospitals allowed residents to order hydroxyurea, 19% required a second signature, and 30% did not allow residents to order hydroxyurea. In our institutional study, patients after the policy change were significantly more likely to have received their home hydroxyurea by hospital day 1: before 62/90 (69%) versus after 105/119 (88%), P=0.0005. The proportion of patients who inappropriately received hydroxyurea was very low in both groups: before 1/91 (1%) versus after 3/126 (2%), P=0.64, with no serious adverse clinical events due to inappropriate hydroxyurea administration. CONCLUSIONS Considerable national variation in practice currently exists in regards to resident hydroxyurea ordering hospital policies. A policy allowing residents to order hydroxyurea significantly increased the likelihood of a patient receiving hydroxyurea while hospitalized with no significant increase in inappropriate hydroxyurea administration. Resident hydroxyurea ordering seems safe and beneficial.",2020,A policy allowing residents to order hydroxyurea significantly increased the likelihood of a patient receiving hydroxyurea while hospitalized with no significant increase in inappropriate hydroxyurea administration.,"['Hospitalized Patients With Sickle Cell Disease', 'medical records of a random sample of patients with SCD on hydroxyurea admitted the year before and the year after this policy change', '39 American pediatric hospitals regarding their policy on resident hydroxyurea ordering for SCD', 'hospitalized patients with SCD who were already on hydroxyurea at home']","['hydroxyurea', 'Hydroxyurea', 'Home Hydroxyurea']",[],"[{'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002895', 'cui_str': 'Sickling disorder due to hemoglobin S'}, {'cui': 'C0025102', 'cui_str': 'Medical record'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0020402', 'cui_str': 'hydroxyurea'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0242456', 'cui_str': 'Policy'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0020017', 'cui_str': ""Children's hospital""}, {'cui': 'C4284072', 'cui_str': 'Order document'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}]","[{'cui': 'C0020402', 'cui_str': 'hydroxyurea'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}]",[],,0.0265303,A policy allowing residents to order hydroxyurea significantly increased the likelihood of a patient receiving hydroxyurea while hospitalized with no significant increase in inappropriate hydroxyurea administration.,"[{'ForeName': 'Rebekah', 'Initials': 'R', 'LastName': 'Shaw', 'Affiliation': ""C. S. Mott Children's Hospital at the University of Michigan, Ann Arbor, MI.""}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Kappa', 'Affiliation': ""Children's National Health System.""}, {'ForeName': 'Robert S', 'Initials': 'RS', 'LastName': 'Nickel', 'Affiliation': ""Children's National Health System.""}]",Journal of pediatric hematology/oncology,['10.1097/MPH.0000000000001638'] 2360,30485422,Reasons for nonadherence and response to treatment in an adherence intervention trial for relapsing-remitting multiple sclerosis patients.,"OBJECTIVES To explore whether patients in an adherence trial who appeared not to take disease modifying therapy (DMT) for avoidance reasons could be reliably identified, by observational coding, for their main reason of not taking DMT. To determine whether reason groups could be distinguished by clinical and self-report psychological characteristics and intervention outcomes. METHOD Participants were multiple sclerosis patients (N = 78, 88.5% female, mean age 45.64) demotivated to take DMT. Audio recordings of the sessions were coded for the main reason of not taking DMT. Reason groups were compared based on patient characteristics and intervention outcomes. RESULTS Avoidance and three other reasons for not taking DMT (side effects, cost, and mild course) were reliably identified (κ = 0.88). Patient characteristics failed to distinguish participants in the Avoidance group, which also had poorer outcomes (X 2 [2, n = 73] = 6.35, p = 0.036). CONCLUSIONS Patients not taking DMT for avoidance reasons may need novel methods to identify them and encourage (re-)initiation.",2019,"Patient characteristics failed to distinguish participants in the Avoidance group, which also had poorer outcomes (X 2 [2, n = 73] = 6.35, p = 0.036). ","['Participants were multiple sclerosis patients (N\u2009=\u200978, 88.5% female, mean age 45.64) demotivated to take DMT', 'patients in an adherence trial who appeared not to take disease modifying therapy (DMT) for avoidance reasons', 'relapsing-remitting multiple sclerosis patients']",[],"['taking DMT (side effects, cost, and mild course']","[{'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0751967', 'cui_str': 'Relapsing remitting multiple sclerosis'}]",[],"[{'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0750729', 'cui_str': 'Courses'}]",,0.035948,"Patient characteristics failed to distinguish participants in the Avoidance group, which also had poorer outcomes (X 2 [2, n = 73] = 6.35, p = 0.036). ","[{'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Schoor', 'Affiliation': 'Department of Psychology, University of Missouri, Kansas City, Missouri.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Bruce', 'Affiliation': 'Department of Pediatrics, University of Kansas Medical Center, Kansas City, Missouri.'}, {'ForeName': 'Jared', 'Initials': 'J', 'LastName': 'Bruce', 'Affiliation': 'Department of Psychology, University of Missouri, Kansas City, Missouri.'}, {'ForeName': 'Kathy', 'Initials': 'K', 'LastName': 'Goggin', 'Affiliation': ""Center for Children's Healthy Lifestyles and Nutrition, Children's Mercy and Hospital Clinics, Kansas City, Missouri.""}, {'ForeName': 'Bethany', 'Initials': 'B', 'LastName': 'Schanfarber', 'Affiliation': 'Department of Psychology, University of Missouri, Kansas City, Missouri.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Bradley-Ewing', 'Affiliation': ""Center for Children's Healthy Lifestyles and Nutrition, Children's Mercy and Hospital Clinics, Kansas City, Missouri.""}, {'ForeName': 'Joanie', 'Initials': 'J', 'LastName': 'Thelen', 'Affiliation': 'Department of Psychology, University of Missouri, Kansas City, Missouri.'}, {'ForeName': 'Morgan', 'Initials': 'M', 'LastName': 'Glusman', 'Affiliation': 'Department of Psychology, University of Missouri, Kansas City, Missouri.'}, {'ForeName': 'Sharon G', 'Initials': 'SG', 'LastName': 'Lynch', 'Affiliation': 'Department of Pediatrics, University of Kansas Medical Center, Kansas City, Missouri.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Strober', 'Affiliation': 'Neuropsychology and Neuroscience Laboratory, Kessler Foundation, West Orange, New Jersey.'}, {'ForeName': 'Delwyn', 'Initials': 'D', 'LastName': 'Catley', 'Affiliation': ""Center for Children's Healthy Lifestyles and Nutrition, Children's Mercy and Hospital Clinics, Kansas City, Missouri.""}]",Journal of clinical psychology,['10.1002/jclp.22725'] 2361,30796109,Effects of Metformin Therapy on Coronary Endothelial Dysfunction in Patients With Prediabetes With Stable Angina and Nonobstructive Coronary Artery Stenosis: The CODYCE Multicenter Prospective Study.,"OBJECTIVE To evaluate the effect of metformin therapy on coronary endothelial function and major adverse cardiac events (MACE) in patients with prediabetes with stable angina and nonobstructive coronary stenosis (NOCS). RESEARCH DESIGN AND METHODS Metformin therapy may be needed to reduce coronary heart disease risk in patients with prediabetes. A total of 258 propensity score-matched (PSM) patients with stable angina undergoing coronary angiography were enrolled in the study. Data from 86 PSM subjects with normoglycemia (NG), 86 PSM subjects with prediabetes (pre-DM), and 86 PSM subjects with prediabetes treated with metformin (pre-DM metformin) were analyzed. During coronary angiography, NOCS was categorized by luminal stenosis <40% and fractional flow reserve >0.80. In addition, we assessed the endothelial function, measuring coronary artery diameter of left anterior descending coronary (LAD) at baseline and after the infusion of acetylcholine, by means of an intracoronary Doppler guide wire. MACE, as cardiac death, myocardial infarction, and heart failure, was evaluated at 24 months of follow-up. RESULTS At baseline, NG patients had a lower percentage of LAD endothelial dysfunction compared with pre-DM patients ( P < 0.05). The pre-DM patients had a higher percentage of endothelial LAD dysfunction as compared with the pre-DM metformin patients ( P < 0.05). At the 24th month of follow-up, MACE was higher in pre-DM versus NG ( P < 0.05). In pre-DM metformin patients, MACE was lower compared with pre-DM patients ( P < 0.05). CONCLUSIONS Metformin therapy may reduce the high risk of cardiovascular events in pre-DM patients by reducing coronary endothelial dysfunction.",2019,"In pre-DM metformin patients, MACE was lower compared with pre-DM patients ( P < 0.05). ","['patients with prediabetes with stable angina and nonobstructive coronary stenosis (NOCS', '258 propensity score-matched (PSM) patients with stable angina undergoing coronary angiography were enrolled in the study', 'Patients With Prediabetes With Stable Angina and Nonobstructive Coronary Artery Stenosis', '86 PSM subjects with normoglycemia (NG), 86 PSM subjects with prediabetes (pre-DM), and 86 PSM subjects with prediabetes treated with', 'patients with prediabetes']","['Metformin Therapy', 'metformin therapy', 'metformin (pre-DM metformin', 'Metformin therapy']","['coronary endothelial function and major adverse cardiac events (MACE', 'Coronary Endothelial Dysfunction', 'cardiac death, myocardial infarction, and heart failure', 'endothelial function, measuring coronary artery diameter of left anterior descending coronary (LAD', 'high risk of cardiovascular events', 'coronary endothelial dysfunction', 'LAD endothelial dysfunction', 'endothelial LAD dysfunction', 'coronary heart disease risk']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0271650', 'cui_str': 'Impaired glucose tolerance'}, {'cui': 'C0340288', 'cui_str': 'Stable angina'}, {'cui': 'C0242231', 'cui_str': 'Coronary artery stenosis'}, {'cui': 'C2718044', 'cui_str': 'Propensity Score'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0085532', 'cui_str': 'Coronary angiography'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}]","[{'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0856169', 'cui_str': 'Endothelial dysfunction'}, {'cui': 'C0376297', 'cui_str': 'Cardiac death'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0205042', 'cui_str': 'Coronary artery structure'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0205386', 'cui_str': 'Descending'}, {'cui': 'C0441998', 'cui_str': 'Left anterior'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C1277690', 'cui_str': 'Coronary heart disease risk'}]",258.0,0.0368894,"In pre-DM metformin patients, MACE was lower compared with pre-DM patients ( P < 0.05). ","[{'ForeName': 'Celestino', 'Initials': 'C', 'LastName': 'Sardu', 'Affiliation': 'Department of Medical, Surgical, Neurological, Metabolic and Aging Sciences, University of Campania ""Luigi Vanvitelli,"" Naples, Italy drsarducele@gmail.com.'}, {'ForeName': 'Pasquale', 'Initials': 'P', 'LastName': 'Paolisso', 'Affiliation': 'Department of Medical, Surgical, Neurological, Metabolic and Aging Sciences, University of Campania ""Luigi Vanvitelli,"" Naples, Italy.'}, {'ForeName': 'Cosimo', 'Initials': 'C', 'LastName': 'Sacra', 'Affiliation': 'Department of Cardiovascular Diseases, John Paul II Research and Care Foundation, Campobasso, Italy.'}, {'ForeName': 'Ciro', 'Initials': 'C', 'LastName': 'Mauro', 'Affiliation': 'Department of Cardiovascular Diseases, Antonio Cardarelli Hospital, Naples, Italy.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Minicucci', 'Affiliation': 'Department of Cardiovascular Diseases, Antonio Cardarelli Hospital, Naples, Italy.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Portoghese', 'Affiliation': 'UOC Division of Cardiovascular Surgery, Sassari Hospital, Sassari, Italy.'}, {'ForeName': 'Maria Rosaria', 'Initials': 'MR', 'LastName': 'Rizzo', 'Affiliation': 'Department of Medical, Surgical, Neurological, Metabolic and Aging Sciences, University of Campania ""Luigi Vanvitelli,"" Naples, Italy.'}, {'ForeName': 'Michelangela', 'Initials': 'M', 'LastName': 'Barbieri', 'Affiliation': 'Department of Medical, Surgical, Neurological, Metabolic and Aging Sciences, University of Campania ""Luigi Vanvitelli,"" Naples, Italy.'}, {'ForeName': 'Ferdinando Carlo', 'Initials': 'FC', 'LastName': 'Sasso', 'Affiliation': 'Department of Medical, Surgical, Neurological, Metabolic and Aging Sciences, University of Campania ""Luigi Vanvitelli,"" Naples, Italy.'}, {'ForeName': 'Nunzia', 'Initials': 'N', 'LastName': ""D'Onofrio"", 'Affiliation': 'Department of Precision Medicine, University of Campania ""Luigi Vanvitelli,"" Naples, Italy.'}, {'ForeName': 'Maria Luisa', 'Initials': 'ML', 'LastName': 'Balestrieri', 'Affiliation': 'Department of Precision Medicine, University of Campania ""Luigi Vanvitelli,"" Naples, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Calabrò', 'Affiliation': ""Division of Clinical Cardiology, AORN Sant'Anna e San Sebastiano, Caserta, Italy.""}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Paolisso', 'Affiliation': 'Department of Medical, Surgical, Neurological, Metabolic and Aging Sciences, University of Campania ""Luigi Vanvitelli,"" Naples, Italy.'}, {'ForeName': 'Raffaele', 'Initials': 'R', 'LastName': 'Marfella', 'Affiliation': 'Department of Medical, Surgical, Neurological, Metabolic and Aging Sciences, University of Campania ""Luigi Vanvitelli,"" Naples, Italy.'}]",Diabetes care,['10.2337/dc18-2356'] 2362,32602170,Genetic Variant in CHRNA5 and Response to Varenicline and Combination Nicotine Replacement in a randomized placebo-controlled trial.,"It is unclear if genetic variants affect smoking cessation treatment response. This study tested whether variants in the cholinergic receptor nicotinic alpha 5 subunit (CHRNA5) predict response to smoking cessation medication by directly comparing two most effective smoking cessation pharmacotherapies. In this genotype-stratified randomized, double-blind, placebo-controlled clinical trial (5/2015-8/2019 in St. Louis, Missouri), smokers were randomized by genotype in blocks of 6 (1:1:1 ratio) to 3 conditions: 12 weeks of placebo (n=273), combination nicotine patch and lozenge (cNRT, n=275), or varenicline (n=274). All participants received counseling and were followed for 12 months. The primary endpoint was biochemically verified 7-day point prevalence abstinence at the end of treatment (EOT, week 12). Trial registration and eligibility criteria are on clinicaltrials.gov (NCT02351167). We conducted the genetic analyses separately for 516 European American (EA) smokers and 306 non-EA smokers (including 270 African American smokers). In African American smokers, there was a genotype-by-treatment interaction for EOT abstinence (X 2 =10.7, df=2. P=0.0049): specifically, cNRT was more effective in smokers with rs16969968 GG genotypes than was placebo, while varenicline was more effective in smokers of GA/AA genotypes. In EA ancestry smokers, there was no significant genotype-by-treatment interaction. In the whole sample, only varenicline, and not cNRT, produced higher abstinence at 6-month follow-up. In the whole sample, although both were effective at EOT, only varenicline, and not cNRT, was significantly effective relative to placebo at 6-month follow-up. Importantly, this study suggests that genetic information can further enhance their effectiveness.",2020,"In the whole sample, only varenicline, and not cNRT, produced higher abstinence at 6-month follow-up.","['African American smokers', '516 European American (EA) smokers and 306 non-EA smokers (including 270 African American smokers']","['varenicline, and not cNRT', 'placebo', 'cholinergic receptor nicotinic alpha 5 subunit (CHRNA5', 'Varenicline and Combination Nicotine Replacement', 'varenicline', 'combination nicotine patch and lozenge (cNRT, n=275), or varenicline', 'cNRT']",['7-day point prevalence abstinence'],"[{'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C4319603', 'cui_str': '270'}]","[{'cui': 'C1569608', 'cui_str': 'varenicline'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0034792', 'cui_str': 'Cholinergic receptor'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0599220', 'cui_str': 'Protein Subunit'}, {'cui': 'C1278444', 'cui_str': 'Nicotine replacement therapy'}, {'cui': 'C0358855', 'cui_str': 'Nicotine Transdermal Patch'}, {'cui': 'C0991564', 'cui_str': 'Lozenge'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}]",,0.197091,"In the whole sample, only varenicline, and not cNRT, produced higher abstinence at 6-month follow-up.","[{'ForeName': 'Li-Shiun', 'Initials': 'LS', 'LastName': 'Chen', 'Affiliation': 'Department of Psychiatry, Washington University School of Medicine, St. Louis, MO, USA.'}, {'ForeName': 'Timothy B', 'Initials': 'TB', 'LastName': 'Baker', 'Affiliation': 'Department of Medicine, University of Wisconsin School of Medicine and Public Health, Madison, WI, USA.'}, {'ForeName': 'J Philip', 'Initials': 'JP', 'LastName': 'Miller', 'Affiliation': 'Department of Psychiatry, Washington University School of Medicine, St. Louis, MO, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Bray', 'Affiliation': 'Department of Psychiatry, Washington University School of Medicine, St. Louis, MO, USA.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Smock', 'Affiliation': 'Department of Psychiatry, Washington University School of Medicine, St. Louis, MO, USA.'}, {'ForeName': 'Jingling', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Department of Psychiatry, Washington University School of Medicine, St. Louis, MO, USA.'}, {'ForeName': 'Faith', 'Initials': 'F', 'LastName': 'Stoneking', 'Affiliation': 'Department of Psychiatry, Washington University School of Medicine, St. Louis, MO, USA.'}, {'ForeName': 'Robert C', 'Initials': 'RC', 'LastName': 'Culverhouse', 'Affiliation': 'John T. Milliken Department of Medicine, Washington University School of Medicine, St. Louis, MO, USA.'}, {'ForeName': 'Nancy L', 'Initials': 'NL', 'LastName': 'Saccone', 'Affiliation': 'Department of Genetics, Washington University School of Medicine, St. Louis, MO, USA.'}, {'ForeName': 'Christopher I', 'Initials': 'CI', 'LastName': 'Amos', 'Affiliation': 'Department of Biomedical Data Science, Geisel School of Medicine, Dartmouth College, Hanover, NH, USA.'}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Carney', 'Affiliation': 'Department of Psychiatry, Washington University School of Medicine, St. Louis, MO, USA.'}, {'ForeName': 'Douglas E', 'Initials': 'DE', 'LastName': 'Jorenby', 'Affiliation': 'Department of Medicine, University of Wisconsin School of Medicine and Public Health, Madison, WI, USA.'}, {'ForeName': 'Laura J', 'Initials': 'LJ', 'LastName': 'Bierut', 'Affiliation': 'Department of Psychiatry, Washington University School of Medicine, St. Louis, MO, USA.'}]",Clinical pharmacology and therapeutics,['10.1002/cpt.1971'] 2363,32602177,A six month extension trial evaluating safety and efficacy of ferric derisomaltose in patients with iron deficiency anemia: The FERWON-EXT trial.,,2020,,['patients with iron deficiency anemia'],['ferric derisomaltose'],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0162316', 'cui_str': 'Iron deficiency anemia'}]","[{'cui': 'C3848561', 'cui_str': 'ferric cation'}]",[],,0.0746263,,"[{'ForeName': 'Maureen M', 'Initials': 'MM', 'LastName': 'Achebe', 'Affiliation': ""Divison of Hematology, Brigham and Women's Hospital, Dana Farber Cancer Institute, Boston, Massachusetts, USA.""}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Glaspy', 'Affiliation': 'Department of Medicine, Division of Hematology Oncology, UCLA School of Medicine, Los Angeles, California, USA.'}, {'ForeName': 'Philip A', 'Initials': 'PA', 'LastName': 'Kalra', 'Affiliation': 'Department of Renal Medicine, Salford Royal NHS Foundation Trust, Salford, UK.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Auerbach', 'Affiliation': 'Department of Medicine, Georgetown University School of Medicine, Washington, District of Columbia, USA.'}, {'ForeName': 'Lars L', 'Initials': 'LL', 'LastName': 'Thomsen', 'Affiliation': 'Department of Clinical and Non-clinical Research, Pharmacosmos A/S, Holbaek, Denmark.'}, {'ForeName': 'Sunil', 'Initials': 'S', 'LastName': 'Bhandari', 'Affiliation': 'Department of Renal Medicine, Hull University Teaching Hospitals NHS Trust, Kingston upon Hull, UK.'}]",American journal of hematology,['10.1002/ajh.25920'] 2364,32600389,Folic acid supplementation in children with sickle cell disease: study protocol for a double-blind randomized cross-over trial.,"BACKGROUND Sickle cell disease (SCD) is a genetic disorder which causes dysfunctional red blood cells (RBC) and is thought to increase requirements for folate, an essential B vitamin, due to increased RBC production and turnover in the disease. High-dose supplementation with 1-5 mg/d folic acid, synthetic folate, has been the standard recommendation for children with SCD. There is concern about whether children with SCD need such high doses of folic acid, following mandatory folic acid fortification of enriched grains in Canada, and advancements in medical therapies which extend the average lifespan of RBCs. In animal and human studies, high folic acid intakes (1 mg/d) have been associated with accelerated growth of some cancers, and the biological effects of circulating unmetabolized folic acid (UMFA), which can occur with doses of folic acid ≥ 0.2 mg/d, are not fully understood. The objective of this study is to determine efficacy of, and alterations in folate metabolism from high-dose folic acid in children with SCD during periods of folic acid supplementation versus no supplementation. METHODS In this double-blind randomized controlled cross-over trial, children with SCD (n = 36, aged 2-19 years) will be randomized to either receive 1 mg/d folic acid, the current standard of care, or a placebo for 12 weeks. After a 12-week washout period, treatments will be reversed. Total folate concentrations (serum and RBC), different folate forms (including UMFA), folate-related metabolites, and clinical outcomes will be measured at baseline and after treatment periods. The sum of the values measured in the two periods will be calculated for each subject and compared across the two sequence groups by means of a test for independent samples for the primary (RBC folate concentrations) and secondary (UMFA) outcomes. Dietary intake will be measured at the beginning of each study period. DISCUSSION As the first rigorously designed clinical trial in children with SCD, this trial will inform and assess current clinical practice, with the ultimate goal of improving nutritional status of children with SCD. TRIAL REGISTRATION ClinicalTrials.gov NCT04011345 . Registered on July 8, 2019.",2020,"In animal and human studies, high folic acid intakes (1 mg/d) have been associated with accelerated growth of some cancers, and the biological effects of circulating unmetabolized folic acid (UMFA), which can occur with doses of folic acid ≥ 0.2 mg/d, are not fully understood.","['children with sickle cell disease', 'children with SCD (n\u2009=\u200936, aged 2-19\xa0years', 'children with SCD', 'children with SCD during periods of folic acid supplementation versus no supplementation']","['folic acid', 'Folic acid supplementation', 'receive 1\u2009mg/d folic acid, the current standard of care, or a placebo']","['Total folate concentrations (serum and RBC), different folate forms (including UMFA), folate-related metabolites, and clinical outcomes']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0002895', 'cui_str': 'Sickling disorder due to hemoglobin S'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0556110', 'cui_str': 'Folic acid supplement agent'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0016410', 'cui_str': 'Folic Acid'}, {'cui': 'C0556110', 'cui_str': 'Folic acid supplement agent'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0178638', 'cui_str': 'Folate'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0014772', 'cui_str': 'Red blood cell count'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0016410', 'cui_str': 'Folic Acid'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.420889,"In animal and human studies, high folic acid intakes (1 mg/d) have been associated with accelerated growth of some cancers, and the biological effects of circulating unmetabolized folic acid (UMFA), which can occur with doses of folic acid ≥ 0.2 mg/d, are not fully understood.","[{'ForeName': 'Brock A', 'Initials': 'BA', 'LastName': 'Williams', 'Affiliation': 'Food, Nutrition, and Health, Faculty of Land and Food Systems, The University of British Columbia, 2205 East Mall, Vancouver, British Columbia, V6T 1Z4, Canada.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'McCartney', 'Affiliation': 'Department of Pediatrics, Faculty of Medicine, The University of British Columbia, 4480 Oak Street, Vancouver, British Columbia, V6H 3V4, Canada.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Adams', 'Affiliation': ""Department of Pharmacy, BC Children's Hospital, 4480 Oak Street, Vancouver, British Columbia, V6H 3V4, Canada.""}, {'ForeName': 'Angela M', 'Initials': 'AM', 'LastName': 'Devlin', 'Affiliation': ""BC Children's Hospital Research Institute, 950 W 28th Avenue, Vancouver, British Columbia, V5Z 4H4, Canada.""}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Singer', 'Affiliation': 'School of Population and Public Health, The University of British Columbia, 2206 East Mall, Vancouver, British Columbia, V6T 1Z3, Canada.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Vercauteren', 'Affiliation': ""BC Children's Hospital Research Institute, 950 W 28th Avenue, Vancouver, British Columbia, V5Z 4H4, Canada.""}, {'ForeName': 'John K', 'Initials': 'JK', 'LastName': 'Wu', 'Affiliation': ""BC Children's Hospital Research Institute, 950 W 28th Avenue, Vancouver, British Columbia, V5Z 4H4, Canada.""}, {'ForeName': 'Crystal D', 'Initials': 'CD', 'LastName': 'Karakochuk', 'Affiliation': 'Food, Nutrition, and Health, Faculty of Land and Food Systems, The University of British Columbia, 2205 East Mall, Vancouver, British Columbia, V6T 1Z4, Canada. crystal.karakochuk@ubc.ca.'}]",Trials,['10.1186/s13063-020-04540-7'] 2365,32600393,Stress ulcer prophylaxis versus placebo-a blinded randomized control trial to evaluate the safety of two strategies in critically ill infants with congenital heart disease (SUPPRESS-CHD).,"BACKGROUND Critically ill infants with congenital heart disease (CHD) are often prescribed stress ulcer prophylaxis (SUP) to prevent upper gastrointestinal bleeding, despite the low incidence of stress ulcers and limited data on the safety and efficacy of SUP in infants. Recently, SUP has been associated with an increased incidence of hospital-acquired infections, community-acquired pneumonia, and necrotizing enterocolitis. The objective of this pilot study is to investigate the feasibility of performing a randomized controlled trial to assess the safety and efficacy of withholding SUP in infants with congenital heart disease admitted to the cardiac intensive care unit. METHODS A single center, prospective, double-blinded, randomized placebo-controlled pilot feasibility trial will be performed in infants with CHD admitted to the cardiac intensive care unit and anticipated to require respiratory support for > 24 h. Patients will be randomized to receive a histamine-2 receptor antagonist (H2RA) or placebo until they are discontinued from respiratory support. Randomization will be performed within 2 strata defined by admission type (medical or surgical) and age (neonate, age < 30 days, or infant, 1 month to 1 year). Allocation will be a 1:1 ratio using permuted blocks to ensure balanced allocations across the two treatment groups within each stratum. The primary outcomes include feasibility of screening, consent, timely allocation of study drug, and protocol adherence. The primary safety outcome is the rate of clinically significant upper gastrointestinal bleeding. The secondary outcomes are the difference in the relative and absolute abundance of the gut microbiota and functional microbial profiles between the two study groups. We plan to enroll 100 patients in this pilot study. DISCUSSION Routine use of SUP to prevent upper gastrointestinal bleeding in infants is controversial due to a low incidence of bleeding events and concern for adverse effects. The role of SUP in infants with CHD has not been examined, and there is equipoise on the risks and benefits of withholding this therapy. In addition, this therapy has been discontinued in other neonatal populations due to the concern for hospital-acquired infections and necrotizing enterocolitis. Furthermore, exploring changes to the microbiome after exposure to SUP may highlight the mechanisms by which SUP impacts potential microbial dysbiosis of the gut and its association with hospital-acquired infections. Assessment of the feasibility of a trial of withholding SUP in critically ill infants with CHD will facilitate planning of a larger multicenter trial of safety and efficacy of SUP in this vulnerable population. TRIAL REGISTRATION ClinicalTrials.gov , NCT03667703. Registered 12 September 2018, https://clinicaltrials.gov/ct2/show/NCT03667703?term=SUPPRESS+CHD&draw=2&rank=1 . All WHO Trial Registration Data Set Criteria are met in this manuscript.",2020,"DISCUSSION Routine use of SUP to prevent upper gastrointestinal bleeding in infants is controversial due to a low incidence of bleeding events and concern for adverse effects.","['ill infants with congenital heart disease (CHD', 'critically ill infants with CHD', '100 patients in this pilot study', 'infants with CHD admitted to the cardiac intensive care unit and anticipated to require respiratory support for ', 'infants with congenital heart disease admitted to the cardiac intensive care unit', 'infants with CHD', 'critically ill infants with congenital heart disease (SUPPRESS-CHD']","['histamine-2 receptor antagonist (H2RA) or placebo', 'SUP', 'withholding SUP', 'placebo']","['feasibility of screening, consent, timely allocation of study drug, and protocol adherence', 'safety and efficacy', 'rate of clinically significant upper gastrointestinal bleeding', 'relative and absolute abundance of the gut microbiota and functional microbial profiles']","[{'cui': 'C0231218', 'cui_str': 'Malaise'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0152021', 'cui_str': 'Congenital heart disease'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031928', 'cui_str': 'Pilot Study'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0587446', 'cui_str': 'Cardiac intensive care unit'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C1260953', 'cui_str': 'Suppressed'}]","[{'cui': 'C0019593', 'cui_str': 'Histamine H2 receptor antagonist'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0400807', 'cui_str': 'Stress ulcer of stomach'}, {'cui': 'C0033107', 'cui_str': 'prevention & control'}]","[{'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0013175', 'cui_str': 'Clinical drug trial'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0041909', 'cui_str': 'Upper gastrointestinal bleeding'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C0205245', 'cui_str': 'Functional'}]",,0.374185,"DISCUSSION Routine use of SUP to prevent upper gastrointestinal bleeding in infants is controversial due to a low incidence of bleeding events and concern for adverse effects.","[{'ForeName': 'Kimberly I', 'Initials': 'KI', 'LastName': 'Mills', 'Affiliation': ""Department of Cardiology, Boston Children's Hospital, Boston, MA, USA.""}, {'ForeName': 'Ben D', 'Initials': 'BD', 'LastName': 'Albert', 'Affiliation': 'Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Lori J', 'Initials': 'LJ', 'LastName': 'Bechard', 'Affiliation': 'Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Christopher P', 'Initials': 'CP', 'LastName': 'Duggan', 'Affiliation': 'Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Aditya', 'Initials': 'A', 'LastName': 'Kaza', 'Affiliation': 'Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Seth', 'Initials': 'S', 'LastName': 'Rakoff-Nahoum', 'Affiliation': 'Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Hera', 'Initials': 'H', 'LastName': 'Vlamakis', 'Affiliation': 'Broad Institute of MIT and Harvard, Boston, MA, USA.'}, {'ForeName': 'Lynn A', 'Initials': 'LA', 'LastName': 'Sleeper', 'Affiliation': ""Department of Cardiology, Boston Children's Hospital, Boston, MA, USA.""}, {'ForeName': 'Jane W', 'Initials': 'JW', 'LastName': 'Newburger', 'Affiliation': ""Department of Cardiology, Boston Children's Hospital, Boston, MA, USA.""}, {'ForeName': 'Gregory P', 'Initials': 'GP', 'LastName': 'Priebe', 'Affiliation': 'Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Nilesh M', 'Initials': 'NM', 'LastName': 'Mehta', 'Affiliation': 'Harvard Medical School, Boston, MA, USA. nilesh.mehta@childrens.harvard.edu.'}]",Trials,['10.1186/s13063-020-04513-w'] 2366,32600394,Repetitive transcranial magnetic stimulation of the prefrontal cortex for fibromyalgia syndrome: a randomised controlled trial with 6-months follow up.,"OBJECTIVES Fibromyalgia Syndrome (FMS), is a chronic pain disorder with poorly understood pathophysiology. In recent years, repetitive transcranial magnetic stimulation (rTMS) has been recommended for pain relief in various chronic pain disorders. The objective of the present research was to study the effect of low frequency rTMS over the right dorsolateral prefrontal cortex (DLPFC) on pain status in FMS. METHODS Ninety diagnosed cases of FMS were randomized into Sham-rTMS and Real-rTMS groups. Real rTMS (1 Hz/1200 pulses/8 trains/90% resting motor threshold) was delivered over the right DLPFC for 5 consecutive days/week for 4 weeks. Pain was assessed by subjective and objective methods along with oxidative stress markers. Patients were followed up for 6 months (post-rTMS;15 days, 3 months and 6 months). RESULTS In Real-rTMS group, average pain ratings and associated symptoms showed significant improvement post rTMS. The beneficial effects of rTMS lasted up to 6 months in the follow-up phase. In Sham-rTMS group, no significant change in pain ratings was observed. CONCLUSION Right DLPFC rTMS can significantly reduce pain and associated symptoms of FMS probably through targeting spinal pain circuits and top-down pain modulation . TRIAL REGISTRATION Ref No: CTRI/2013/12/004228.",2020,"Right DLPFC rTMS can significantly reduce pain and associated symptoms of FMS probably through targeting spinal pain circuits and top-down pain modulation . ","['Ninety diagnosed cases of FMS', 'Fibromyalgia Syndrome (FMS', 'fibromyalgia syndrome']","['Real rTMS', 'Sham-rTMS', 'Right DLPFC rTMS', 'rTMS', 'Repetitive transcranial magnetic stimulation', 'repetitive transcranial magnetic stimulation (rTMS', 'low frequency rTMS', 'Sham-rTMS and Real-rTMS']","['average pain ratings', 'pain and associated symptoms of FMS', 'Pain', 'pain ratings']","[{'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0016053', 'cui_str': 'Fibromyalgia'}]","[{'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C4019080', 'cui_str': 'Prefrontal Cortex, Dorsolateral'}, {'cui': 'C0205213', 'cui_str': 'Low frequency'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0521989', 'cui_str': 'Associated symptom'}, {'cui': 'C0016053', 'cui_str': 'Fibromyalgia'}]",90.0,0.0753615,"Right DLPFC rTMS can significantly reduce pain and associated symptoms of FMS probably through targeting spinal pain circuits and top-down pain modulation . ","[{'ForeName': 'Suman', 'Initials': 'S', 'LastName': 'Tanwar', 'Affiliation': 'Department of Physiology, AIIMS, New Delhi, 110029, India.'}, {'ForeName': 'Bhawna', 'Initials': 'B', 'LastName': 'Mattoo', 'Affiliation': 'Department of Physiology, AIIMS, New Delhi, 110029, India.'}, {'ForeName': 'Uma', 'Initials': 'U', 'LastName': 'Kumar', 'Affiliation': 'Department of Rheumatology, All India Institute of Medical Sciences, AIIMS, New Delhi, 110029, India.'}, {'ForeName': 'Renu', 'Initials': 'R', 'LastName': 'Bhatia', 'Affiliation': 'Department of Physiology, AIIMS, New Delhi, 110029, India. renuaiims28@gmail.com.'}]","Advances in rheumatology (London, England)",['10.1186/s42358-020-00135-7'] 2367,32600400,Internet-based psychodynamic versus cognitive behaviour therapy for adolescents with depression: study protocol for a non-inferiority randomized controlled trial (the ERiCA study).,"BACKGROUND Adolescent depression is a common mental health problem and there is an urgent need for effective and accessible treatments. Internet-based interventions solve many obstacles for seeking and receiving treatment, thus increasing access to effective treatments. Internet-based cognitive behavioural therapy (ICBT) for adolescent depression has demonstrated efficacy in previous trials. In order to broaden the range of evidence-based treatments for young people, we evaluated a newly developed affect-focused Internet-based psychodynamic treatment (IPDT) in a previous study with promising results. The purpose of the planned study is to evaluate the efficacy of IPDT for adolescent depression in a non-inferiority trial, comparing it to ICBT. METHODS The study will employ a parallel randomized non-inferiority design (ratio 1:1; n = 270). Eligible participants are adolescents 15-19 years suffering from depression. The primary hypothesis is that IPDT will be non-inferior to ICBT in reducing depressive symptoms from pre-treatment to end of treatment. Secondary research questions include comparing outcomes of IPDT and ICBT regarding anxiety symptoms, emotion regulation and self-compassion. Additional data will be collected to evaluate cost-effectiveness as well as investigating predictors, moderators and mediators of outcome. In addition, we will examine long-term outcome up to 1 year after end of treatment. Diagnostic interviews with MINI 7.0 will be used to establish primary diagnosis of depression as well as ruling out any exclusion criteria. Both treatments consist of eight modules over 10 weeks, complemented with therapist support through text messages and weekly chat sessions. Primary outcome measure is the Quick Inventory of Depressive Symptomatology in Adolescents Self-Rated (QIDS-A17-SR). Primary outcome will be analysed using data from all participants entering the study using a multilevel growth curve strategy based on the weekly measurements of QIDS-A17-SR. The non-inferiority margin is defined as d = 0.30. DISCUSSION This trial will demonstrate whether IPDT is non-inferior to ICBT in the treatment of adolescent depression. The study might therefore broaden the range of evidence-based treatment alternatives for young people struggling with depression. Further analyses of data from this trial may increase our knowledge about ""what works for whom"" and the pathways of change for two distinct types of interventions. TRIAL REGISTRATION ISRCTN12552584 , Registered on 13 August 2019.",2020,"Secondary research questions include comparing outcomes of IPDT and ICBT regarding anxiety symptoms, emotion regulation and self-compassion.","['young people', 'young people struggling with depression', 'adolescents with depression', 'Eligible participants are adolescents 15-19\u2009years suffering from depression']","['IPDT', 'Internet-based psychodynamic versus cognitive behaviour therapy', 'Internet-based cognitive behavioural therapy (ICBT']","['IPDT and ICBT regarding anxiety symptoms, emotion regulation and self-compassion', 'Quick Inventory of Depressive Symptomatology in Adolescents Self-Rated (QIDS-A17-SR', 'depressive symptoms']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C4720917', 'cui_str': 'Quick inventory of depressive symptomatology'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0585291', 'cui_str': 'Four times daily'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]",,0.164366,"Secondary research questions include comparing outcomes of IPDT and ICBT regarding anxiety symptoms, emotion regulation and self-compassion.","[{'ForeName': 'Jakob', 'Initials': 'J', 'LastName': 'Mechler', 'Affiliation': 'Department of Psychology, Stockholm University, Stockholm, Sweden.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Lindqvist', 'Affiliation': 'Department of Psychology, Stockholm University, Stockholm, Sweden.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Carlbring', 'Affiliation': 'Department of Psychology, Stockholm University, Stockholm, Sweden.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Lilliengren', 'Affiliation': 'Ersta Sköndal Bräcke University College, Stockholm, Sweden.'}, {'ForeName': 'Fredrik', 'Initials': 'F', 'LastName': 'Falkenström', 'Affiliation': 'Department of Behavioural Sciences and Learning, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Gerhard', 'Initials': 'G', 'LastName': 'Andersson', 'Affiliation': 'Department of Behavioural Sciences and Learning, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Naira', 'Initials': 'N', 'LastName': 'Topooco', 'Affiliation': 'Department of Behavioural Sciences and Learning, Linköping University, Linköping, Sweden.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Johansson', 'Affiliation': 'Department of Psychology, Stockholm University, Stockholm, Sweden.'}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Midgley', 'Affiliation': 'Child Attachment and Psychological Therapies Research Unit (ChAPTRe), Anna Freud Centre, London, UK.'}, {'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Edbrooke-Childs', 'Affiliation': 'Department of Clinical, Educational and Health Psychology, University College London, London, UK.'}, {'ForeName': 'Hanne-Sofie', 'Initials': 'HS', 'LastName': 'J Dahl', 'Affiliation': 'Vestfold Hospital Trust, Tønsberg, Norway.'}, {'ForeName': 'Rolf', 'Initials': 'R', 'LastName': 'Sandell', 'Affiliation': 'Department of Psychology, Lund University, Lund, Sweden.'}, {'ForeName': 'Agneta', 'Initials': 'A', 'LastName': 'Thorén', 'Affiliation': 'The Erica Foundation, Stockholm, Sweden.'}, {'ForeName': 'Randi', 'Initials': 'R', 'LastName': 'Ulberg', 'Affiliation': 'Division of Mental Health and Addiction, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Katja', 'Initials': 'K', 'LastName': 'Lindert Bergsten', 'Affiliation': 'Department of Psychology, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Björn', 'Initials': 'B', 'LastName': 'Philips', 'Affiliation': 'Department of Psychology, Stockholm University, Stockholm, Sweden. Bjorn.philips@psychology.su.se.'}]",Trials,['10.1186/s13063-020-04491-z'] 2368,32600406,Personalized dosing of nicotine replacement therapy versus standard dosing for the treatment of individuals with tobacco dependence: study protocol for a randomized placebo-controlled trial.,"BACKGROUND Medications for smoking cessation are currently only effective in helping a minority of smokers quit. Drug development is slow and expensive; as such, there is much interest in optimizing the effectiveness of existing treatments and medications. Current standard doses of nicotine replacement therapy are not effective for many smokers, and in many cases, the amount of nicotine provided is much less than when a smoker is smoking their usual number of cigarettes. The proposed study will test if titrating the dose of the nicotine patch (up to 84 mg) will improve quitting success compared to those receiving a 21-mg nicotine patch with increasing doses of placebo patch. METHODS This is a multicenter, pragmatic, two-arm, placebo-controlled, block randomized controlled trial. We will recruit participants who smoke at least 10 cigarettes daily and are interested in making a quit attempt. After 2 weeks of usual treatment with a 21-mg patch, participants who fail to quit smoking (target n = 400) will be randomized to receive escalating doses of a nicotine patch vs matching placebo patches for an additional 10 weeks or up to a maximum dose of 84 mg per day. Those who stop smoking during the first 2 weeks of usual treatment will continue with 21 mg patch treatment for 10 weeks and will form an additional comparison arm. In addition to the medication, participants will receive brief behavioral counseling at each study visit. The primary outcome will be biochemically confirmed continuous abstinence from smoking during the last 4 weeks of treatment (weeks 9 to 12). DISCUSSION Research evidence supporting the effectiveness of personalized doses of nicotine replacement therapy could change current practice in a variety of healthcare settings. Given the evidence that quitting smoking at any age diminishes the risk of tobacco-related morbidity and mortality, even small increases in absolute quit rates can have a substantial population-level impact on reducing smoking-related disease, mortality rates, and associated healthcare costs. TRIAL REGISTRATION ClinicalTrials.gov, NCT03000387 . Registered on 22 December 2016.",2020,"DISCUSSION Research evidence supporting the effectiveness of personalized doses of nicotine replacement therapy could change current practice in a variety of healthcare settings.","['participants who fail to quit smoking (target n\u2009=\u2009400', 'individuals with tobacco dependence']","['nicotine patch vs matching placebo patches', 'nicotine patch', 'nicotine replacement therapy', 'placebo patch', 'placebo']",['quitting success'],"[{'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0040332', 'cui_str': 'Tobacco dependence syndrome'}]","[{'cui': 'C0358855', 'cui_str': 'Nicotine Transdermal Patch'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332461', 'cui_str': 'Plaque'}, {'cui': 'C1278444', 'cui_str': 'Nicotine replacement therapy'}]",[],,0.355217,"DISCUSSION Research evidence supporting the effectiveness of personalized doses of nicotine replacement therapy could change current practice in a variety of healthcare settings.","[{'ForeName': 'Laurie', 'Initials': 'L', 'LastName': 'Zawertailo', 'Affiliation': 'Nicotine Dependence Services, Centre for Addiction and Mental Health, 175 College St, Toronto, Ontario, M5T 1P7, Canada.'}, {'ForeName': 'Christian S', 'Initials': 'CS', 'LastName': 'Hendershot', 'Affiliation': ""Department of Pharmacology and Toxicology, University of Toronto, 1 King's College Circle, Toronto, M5S 1A8, Canada.""}, {'ForeName': 'Rachel F', 'Initials': 'RF', 'LastName': 'Tyndale', 'Affiliation': ""Department of Pharmacology and Toxicology, University of Toronto, 1 King's College Circle, Toronto, M5S 1A8, Canada.""}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Le Foll', 'Affiliation': ""Department of Pharmacology and Toxicology, University of Toronto, 1 King's College Circle, Toronto, M5S 1A8, Canada.""}, {'ForeName': 'Andriy V', 'Initials': 'AV', 'LastName': 'Samokhvalov', 'Affiliation': 'Department of Psychiatry, University of Toronto, 250 College Street, Toronto, Ontario, M5T 1R8, Canada.'}, {'ForeName': 'Kevin E', 'Initials': 'KE', 'LastName': 'Thorpe', 'Affiliation': 'Dalla Lana School of Public Health, 155 College St., Toronto, Ontario, M5T 3M7, Canada.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Pipe', 'Affiliation': 'University of Ottawa Heart Institute, 40 Ruskin St., Ottawa, Ontario, K1Y 4W7, Canada.'}, {'ForeName': 'Robert D', 'Initials': 'RD', 'LastName': 'Reid', 'Affiliation': 'University of Ottawa Heart Institute, 40 Ruskin St., Ottawa, Ontario, K1Y 4W7, Canada.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Selby', 'Affiliation': 'Nicotine Dependence Services, Centre for Addiction and Mental Health, 175 College St, Toronto, Ontario, M5T 1P7, Canada. peter.selby@camh.ca.'}]",Trials,['10.1186/s13063-020-04532-7'] 2369,32600745,The effect of residual bone height and membrane thickness on sinus membrane perforation in crestal sinus grafting: A prospective clinical study.,"This study sought to determine the rate of sinus membrane perforation in patients undergoing crestal sinus grafting, as well as the effect of Schneiderian membrane thickness and residual bone height (RBH) on membrane perforation, using cone beam computed tomography. The study included 25 patients undergoing 44 crestal sinus grafting procedures. The sites for crestal sinus grafting were divided into a control group (RBH≥5mm) and a test group (RBH<5mm). All sinus grafting procedures were also categorised based on membrane thickness: group A (<1mm), group B (1-2mm), and group C (≥2mm). The rate of membrane perforation was 18.2%. The median RBH measurement was 5.59mm. No statistically significant difference in membrane perforation rate was found between the test and control groups (P=0.262). The median thickness of the Schneiderian membrane was 1.35mm. There was no statistically significant difference in membrane perforation among the three membrane thickness groups (P=0.431). No significant correlation between RBH and membrane perforation was observed, although clinical observation indicated that there was a tendency for an increased membrane perforation rate in the presence of a RBH<5mm. The perforation rate was found to be at its highest when the membrane was thinner than 1mm.",2020,No statistically significant difference in membrane perforation rate was found between the test and control groups (P=0.262).,"['crestal sinus grafting', 'patients undergoing crestal sinus grafting', '25 patients undergoing 44 crestal sinus grafting procedures']",['residual bone height and membrane thickness'],"['membrane perforation', 'membrane perforation rate', 'rate of membrane perforation', 'median RBH measurement', 'median thickness of the Schneiderian membrane', 'RBH and membrane perforation', 'perforation rate', 'rate of sinus membrane perforation']","[{'cui': 'C2236586', 'cui_str': 'Sinus augmentation'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0025255', 'cui_str': 'Membrane Tissue'}, {'cui': 'C1280412', 'cui_str': 'Thick'}]","[{'cui': 'C0025255', 'cui_str': 'Membrane Tissue'}, {'cui': 'C0549099', 'cui_str': 'Perforation'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C4704901', 'cui_str': 'Schneiderian Membrane'}, {'cui': 'C0016169', 'cui_str': 'Fistula'}]",25.0,0.0144395,No statistically significant difference in membrane perforation rate was found between the test and control groups (P=0.262).,"[{'ForeName': 'D Uçar', 'Initials': 'DU', 'LastName': 'Boyacıgil', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Mamak Oral and Dental Health Hospital, Ankara, Turkey.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Er', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Hacettepe University, Ankara, Turkey.'}, {'ForeName': 'Ç', 'Initials': 'Ç', 'LastName': 'Karaca', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Hacettepe University, Ankara, Turkey. Electronic address: cigdem.karaca@hacettepe.edu.tr.'}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'Koç', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Hacettepe University, Ankara, Turkey.'}]",International journal of oral and maxillofacial surgery,['10.1016/j.ijom.2020.05.018'] 2370,32600857,Feasibility of a multimodal intervention on malnutrition in patients with lung cancer during primary anti-neoplastic treatment.,"BACKGROUND Wasting of body mass and skeletal muscle frequently develops in patients with cancer and is associated with impaired functional ability and poor clinical outcome and quality of life. This study aimed to evaluate the feasibility and explore the effect of a multimodal intervention targeting nutritional status in patients with non-small cell lung cancer receiving primary anti-neoplastic treatment. Additionally, predictive and prognostic factors of gaining skeletal muscle were explored. METHODS This was a single-centre multimodal intervention trial using a historical control group. The multimodal intervention involved fish oil intake (2 g of eicosapentaenoic acid or docosahexaenoic acid daily), regular dietary counselling and unsupervised physical exercise twice weekly during the first three cycles of primary anti-neoplastic treatment. Feasibility was assessed through recruitment rate, completion rate and compliance rate with the intervention. Differences in skeletal muscle, body weight, and physical function between the intervention and historical control groups were analysed. Factors contributing to increased skeletal muscle were explored using univariate and multivariate ordinal logistic regression analyses. RESULTS The recruitment and completion rates were 0.48 (n = 59/123) and 0.80 (n = 46/59), respectively. The overall compliance rate with all five individual interventions was 0.60 (n = 28/47). The individual compliance rates were 0.81 (n = 38/47) with fish oil intake, 0.94 (n = 44/47) with energy intake, 0.98 (n = 46/47) with protein intake, 0.51 (n = 24/47) with resistance exercise and 0.57 (n = 27/47) with aerobic exercise. No mean differences in skeletal muscle, body weight, or physical function were found between the intervention and control groups. However, a larger proportion of patients in the intervention group gained skeletal muscle (p < 0.02). The identified contributing factors of muscle gain were weight gain (OR, 1.3; p = 0.01), adherence to treatment plan (OR, 4.6; p = 0.02), stable/partial response (OR, 3.3; p = 0.04) and compliance to the intervention (OR, 7.4; p = 0.01). Age, sex, tumour stage, performance status, treatment type and baseline cachexia did not predict muscle gain. CONCLUSION This three-dimensional intervention in patients with lung cancer undergoing primary anti-neoplastic treatment was feasible and increased the proportion of patients gaining skeletal muscle. Dietary counselling and fish oil use were useful strategies. The motivation for conducting unsupervised physical intervention was low. Clinical trials.gov identifier: NCT04161794.",2020,"The identified contributing factors of muscle gain were weight gain (OR, 1.3; p = 0.01),","['patients with non-small cell lung cancer receiving primary anti-neoplastic treatment', 'patients with lung cancer undergoing primary anti-neoplastic treatment', 'patients with lung cancer during primary anti-neoplastic treatment', 'patients with cancer']","['Dietary counselling and fish oil', 'multimodal intervention involved fish oil intake (2\xa0g of eicosapentaenoic acid or docosahexaenoic acid daily), regular dietary counselling and unsupervised physical exercise', 'resistance exercise', 'multimodal intervention', 'aerobic exercise']","['individual compliance rates', 'skeletal muscle, body weight, or physical function', 'stable/partial response', 'recruitment rate, completion rate and compliance rate', 'overall compliance rate', 'skeletal muscle, body weight, and physical function', 'skeletal muscle', 'recruitment and completion rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}]","[{'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0016157', 'cui_str': 'Fish Oils'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0000545', 'cui_str': 'Eicosapentaenoic acid'}, {'cui': 'C0012968', 'cui_str': 'Docosahexenoic Acids'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}]","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C1521726', 'cui_str': 'In partial remission'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",,0.0752577,"The identified contributing factors of muscle gain were weight gain (OR, 1.3; p = 0.01),","[{'ForeName': 'Randi', 'Initials': 'R', 'LastName': 'Tobberup', 'Affiliation': 'Center for Nutrition and Bowel Disease, Department of Gastroenterology, Aalborg University Hospital, Mølleparkvej 4, 9000, Aalborg, Denmark; Department of Clinical Medicine, Faculty of Medicine, Aalborg University, Sdr. Skovvej 5, 9000, Aalborg, Denmark; Clinical Cancer Research Center, Aalborg University Hospital, Hobrovej 18-22, 9000, Aalborg, Denmark. Electronic address: r.tobberup@rn.dk.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Carus', 'Affiliation': 'Department of Clinical Medicine, Faculty of Medicine, Aalborg University, Sdr. Skovvej 5, 9000, Aalborg, Denmark; Department of Oncology, Clinical Cancer Research Center, Aalborg University Hospital, Hobrovej 18-22, 9000, Aalborg, Denmark; Clinical Cancer Research Center, Aalborg University Hospital, Hobrovej 18-22, 9000, Aalborg, Denmark.'}, {'ForeName': 'Henrik H', 'Initials': 'HH', 'LastName': 'Rasmussen', 'Affiliation': 'Center for Nutrition and Bowel Disease, Department of Gastroenterology, Aalborg University Hospital, Mølleparkvej 4, 9000, Aalborg, Denmark; Department of Clinical Medicine, Faculty of Medicine, Aalborg University, Sdr. Skovvej 5, 9000, Aalborg, Denmark.'}, {'ForeName': 'Ursula G', 'Initials': 'UG', 'LastName': 'Falkmer', 'Affiliation': 'Department of Clinical Medicine, Faculty of Medicine, Aalborg University, Sdr. Skovvej 5, 9000, Aalborg, Denmark; Department of Oncology, Clinical Cancer Research Center, Aalborg University Hospital, Hobrovej 18-22, 9000, Aalborg, Denmark; Clinical Cancer Research Center, Aalborg University Hospital, Hobrovej 18-22, 9000, Aalborg, Denmark.'}, {'ForeName': 'Martin G', 'Initials': 'MG', 'LastName': 'Jorgensen', 'Affiliation': 'Department of Geriatric Medicine, Aalborg University Hospital, Hobrovej 18-22, Aalborg, Denmark.'}, {'ForeName': 'Erik B', 'Initials': 'EB', 'LastName': 'Schmidt', 'Affiliation': 'Department of Cardiology, Aalborg AF Study Group, Aalborg University Hospital, Sdr. Skovvej 15, Aalborg, Denmark.'}, {'ForeName': 'Nikolaj A', 'Initials': 'NA', 'LastName': 'Jensen', 'Affiliation': 'Department of Oncology, Clinical Cancer Research Center, Aalborg University Hospital, Hobrovej 18-22, 9000, Aalborg, Denmark; Clinical Cancer Research Center, Aalborg University Hospital, Hobrovej 18-22, 9000, Aalborg, Denmark.'}, {'ForeName': 'Esben B', 'Initials': 'EB', 'LastName': 'Mark', 'Affiliation': 'Mech-Sense, Department of Gastroenterology and Hepatology, Aalborg University Hospital, Hobrovej 18-22, Aalborg, Denmark.'}, {'ForeName': 'Agnieszka M', 'Initials': 'AM', 'LastName': 'Delekta', 'Affiliation': 'Department of Radiology, Aalborg University Hospital, Hobrovej 18-22, Aalborg, Denmark.'}, {'ForeName': 'Christian S', 'Initials': 'CS', 'LastName': 'Antoniussen', 'Affiliation': 'Department of Public Health, Aarhus University, Bartholins Allé 2, Aarhus, Denmark.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Bøgsted', 'Affiliation': 'Department of Clinical Medicine, Faculty of Medicine, Aalborg University, Sdr. Skovvej 5, 9000, Aalborg, Denmark; Department of Oncology, Clinical Cancer Research Center, Aalborg University Hospital, Hobrovej 18-22, 9000, Aalborg, Denmark.'}, {'ForeName': 'Mette', 'Initials': 'M', 'LastName': 'Holst', 'Affiliation': 'Center for Nutrition and Bowel Disease, Department of Gastroenterology, Aalborg University Hospital, Mølleparkvej 4, 9000, Aalborg, Denmark; Department of Clinical Medicine, Faculty of Medicine, Aalborg University, Sdr. Skovvej 5, 9000, Aalborg, Denmark.'}]","Clinical nutrition (Edinburgh, Scotland)",['10.1016/j.clnu.2020.05.050'] 2371,32600858,"Efficacy of a partially hydrolysed formula, with reduced lactose content and with Lactobacillus reuteri DSM 17938 in infant colic: A double blind, randomised clinical trial.","BACKGROUND & AIMS We aimed to compare the efficacy of a partially hydrolysed formula (pHF) with reduced lactose content and Lactobacillus reuteri DSM 17938 (L. reuteri) with a standard formula in infant colic (IC). METHODS We performed a double blind, parallel-group randomized active-controlled. Inclusion criteria were: exclusively formula fed, full term infants, aged <4 months, diagnosis of IC. All the enrolled infants were randomized to receive either pHF with reduced lactose content and L. reuteri (Group A) or standard formula (Group B). The treatment duration was 4 weeks and children were followed-up to 8 weeks. The primary outcome was the mean infant crying duration at 28 days. RESULTS Two-hundred-forty-one children were randomized to the treatments' group (Group A = 124; Group B = 117). Mean daily crying time at 28th day was significantly lower in Group B when compared to Group A [104.7 (87-122.4) versus 146.4 min (129.2-163.7), treatment effect -41.8 (95% C.I.: -66.5 to -17.1), p = 0.001]. No significant adverse event was reported in both groups. CONCLUSIONS Standard formula showed a lower overall crying time respect to the intervention formula (ClinicalTrials.govNCT02813772).",2020,"No significant adverse event was reported in both groups. ","['infant colic (IC', 'Inclusion criteria were: exclusively formula fed, full term infants, aged <4 months, diagnosis of IC', 'Two-hundred-forty-one children', '17938 in infant colic']","['partially hydrolysed formula (pHF) with reduced lactose content and Lactobacillus reuteri DSM 17938 (L. reuteri', 'pHF with reduced lactose content and L.\xa0reuteri (Group A) or standard formula', 'partially hydrolysed formula, with reduced lactose content and with Lactobacillus reuteri DSM']","['overall crying time', 'adverse event', 'Mean daily crying time', 'mean infant crying duration at 28 days']","[{'cui': 'C0266836', 'cui_str': 'Infantile colic'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0204695', 'cui_str': 'Feeding patient'}, {'cui': 'C4551581', 'cui_str': 'Term baby'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0022949', 'cui_str': 'Lactose'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0317625', 'cui_str': 'Lactobacillus reuteri'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C3853255', 'cui_str': 'Standard formula'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0010399', 'cui_str': 'Crying'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0581876', 'cui_str': 'Crying infant'}, {'cui': 'C0449238', 'cui_str': 'Duration'}]",241.0,0.469752,"No significant adverse event was reported in both groups. ","[{'ForeName': 'Rossella', 'Initials': 'R', 'LastName': 'Turco', 'Affiliation': 'Department of Translational Medical Science, Section of Pediatrics, University of Naples ""Federico II"", Naples, Italy. Electronic address: rossella-turco@hotmail.it.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Russo', 'Affiliation': 'Department of Translational Medical Science, Section of Pediatrics, University of Naples ""Federico II"", Naples, Italy. Electronic address: marin_russo@libero.it.'}, {'ForeName': 'Dario', 'Initials': 'D', 'LastName': 'Bruzzese', 'Affiliation': 'Department of Public Health, University of Naples ""Federico II"", Naples, Italy. Electronic address: dbruzzes@unina.it.'}, {'ForeName': 'Annamaria', 'Initials': 'A', 'LastName': 'Staiano', 'Affiliation': 'Department of Translational Medical Science, Section of Pediatrics, University of Naples ""Federico II"", Naples, Italy. Electronic address: staiano@unina.it.'}]","Clinical nutrition (Edinburgh, Scotland)",['10.1016/j.clnu.2020.05.048'] 2372,32600859,Differential effects of protein intake versus intake of a defined oligopeptide on FGF-21 in obese human subjects in vivo.,"BACKGROUND FGF-21 is described as a powerful metabolic regulator with beneficial effects including glucose-lowering and improvement of insulin sensitivity without hypoglycaemia. On the other hand, FGF-21 is activated when muscle and other tissues are stressed by external effects or internal cellular pathogens that lead to shortcomings in metabolic balance. Previous results suggested that FGF-21 could be a promising target to develop future metabolic therapeutics. PURPOSE The present study was performed to gain deeper insight into the regulation of FGF-21 by protein metabolism in obese human subjects. METHODS FGF-21 serum concentrations were measured in a cohort of n = 246 obese humans ± type 2 diabetes mellitus (T2DM) (median age 53.0 [46.0; 60.0] years and BMI 40.43 [35.11; 47.24] kg/m 2 ) and related to the nutritional protein intake. In addition, the effect of a novel oligopeptide purified from a β-casein hydrolysate on FGF-21 was examined in vitro in liver cells and in vivo in a human intervention study with the main focus on metabolic inflammation including 40 mainly obese subjects (mean age 41.08 ± 9.76 years, mean BMI 38.29 ± 9.4 kg/m 2 ) in a randomized 20 weeks double-blind cross-over design. MAIN FINDINGS In the cohort analysis, FGF-21 serum concentrations were significant lower with higher protein intake in obese subjects without T2DM but not in obese subjects with T2DM. Furthermore, relative methionine intake was inversely related to FGF-21. While global protein intake in obesity was inversely associated with FGF-21, incubation of HepG2 cells with a β-casein oligopeptide increased FGF-21 expression in vitro. This stimulatory effect was also present in vivo, since in the clinical intervention study treatment of obese subjects with the β-casein oligopeptide for 8 weeks significantly increased FGF-21 serum levels from W0 = 23.86 pg/mL to W8 = 30.54 pg/mL (p < 0.001), while no increase was found for placebo. CONCLUSION While the total nutritional protein intake is inversely associated with FGF-21 serum levels, a purified and well characterised oligopeptide is able to induce FGF-21 serum levels in humans. These findings suggest a differential role of various components of protein metabolism on FGF-21, rather than this factor being solely a sensor of total nutritional protein intake.",2020,"In the cohort analysis, FGF-21 serum concentrations were significant lower with higher protein intake in obese subjects without T2DM but not in obese subjects with T2DM.","['n\xa0=\xa0246 obese humans\xa0±\xa0type 2 diabetes mellitus (T2DM) (median age 53.0 [46.0; 60.0] years and BMI 40.43 [35.11; 47.24] kg/m 2 ) and related to the nutritional protein intake', 'obese human subjects in\xa0vivo', 'obese subjects', '40 mainly obese subjects (mean age 41.08\xa0±\xa09.76 years, mean BMI 38.29\xa0±', 'obese human subjects']",['FGF-21'],"['FGF-21 serum levels', 'FGF-21 expression', 'relative methionine intake', 'FGF-21 serum concentrations']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0080105', 'cui_str': 'Human Subjects'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]","[{'cui': 'C0972232', 'cui_str': 'fibroblast growth factor 21'}]","[{'cui': 'C0972232', 'cui_str': 'fibroblast growth factor 21'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",246.0,0.0354782,"In the cohort analysis, FGF-21 serum concentrations were significant lower with higher protein intake in obese subjects without T2DM but not in obese subjects with T2DM.","[{'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Fangmann', 'Affiliation': 'Division of Endocrinology, Diabetes and Clinical Nutrition, Department of Internal Medicine 1, University Hospital Schleswig-Holstein, Campus Kiel, University of Kiel, Kiel, 24105, Germany.'}, {'ForeName': 'Corinna', 'Initials': 'C', 'LastName': 'Geisler', 'Affiliation': 'Division of Endocrinology, Diabetes and Clinical Nutrition, Department of Internal Medicine 1, University Hospital Schleswig-Holstein, Campus Kiel, University of Kiel, Kiel, 24105, Germany.'}, {'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Schlicht', 'Affiliation': 'Division of Endocrinology, Diabetes and Clinical Nutrition, Department of Internal Medicine 1, University Hospital Schleswig-Holstein, Campus Kiel, University of Kiel, Kiel, 24105, Germany.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Hartmann', 'Affiliation': 'Division of Endocrinology, Diabetes and Clinical Nutrition, Department of Internal Medicine 1, University Hospital Schleswig-Holstein, Campus Kiel, University of Kiel, Kiel, 24105, Germany.'}, {'ForeName': 'Jana', 'Initials': 'J', 'LastName': 'Köpke', 'Affiliation': 'Division of Endocrinology, Diabetes and Clinical Nutrition, Department of Internal Medicine 1, University Hospital Schleswig-Holstein, Campus Kiel, University of Kiel, Kiel, 24105, Germany.'}, {'ForeName': 'Anika', 'Initials': 'A', 'LastName': 'Tiede', 'Affiliation': 'Division of Endocrinology, Diabetes and Clinical Nutrition, Department of Internal Medicine 1, University Hospital Schleswig-Holstein, Campus Kiel, University of Kiel, Kiel, 24105, Germany.'}, {'ForeName': 'Ute', 'Initials': 'U', 'LastName': 'Settgast', 'Affiliation': 'Division of Endocrinology, Diabetes and Clinical Nutrition, Department of Internal Medicine 1, University Hospital Schleswig-Holstein, Campus Kiel, University of Kiel, Kiel, 24105, Germany.'}, {'ForeName': 'Kathrin', 'Initials': 'K', 'LastName': 'Türk', 'Affiliation': 'Division of Endocrinology, Diabetes and Clinical Nutrition, Department of Internal Medicine 1, University Hospital Schleswig-Holstein, Campus Kiel, University of Kiel, Kiel, 24105, Germany.'}, {'ForeName': 'Dominik M', 'Initials': 'DM', 'LastName': 'Schulte', 'Affiliation': 'Division of Endocrinology, Diabetes and Clinical Nutrition, Department of Internal Medicine 1, University Hospital Schleswig-Holstein, Campus Kiel, University of Kiel, Kiel, 24105, Germany.'}, {'ForeName': 'Karina', 'Initials': 'K', 'LastName': 'Altmann', 'Affiliation': 'Max Rubner-Institute, Federal Research Institute of Nutrition and Food, Department of Safety and Quality of Milk and Fish Products, Kiel, 24103, Germany.'}, {'ForeName': 'Ingrid', 'Initials': 'I', 'LastName': 'Clawin-Rädecker', 'Affiliation': 'Max Rubner-Institute, Federal Research Institute of Nutrition and Food, Department of Safety and Quality of Milk and Fish Products, Kiel, 24103, Germany.'}, {'ForeName': 'Peter Ch', 'Initials': 'PC', 'LastName': 'Lorenzen', 'Affiliation': 'Max Rubner-Institute, Federal Research Institute of Nutrition and Food, Department of Safety and Quality of Milk and Fish Products, Kiel, 24103, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Schreiber', 'Affiliation': 'Division of Endocrinology, Diabetes and Clinical Nutrition, Department of Internal Medicine 1, University Hospital Schleswig-Holstein, Campus Kiel, University of Kiel, Kiel, 24105, Germany; Institute of Clinical Molecular Biology, University Hospital Schleswig-Holstein, Campus Kiel, University of Kiel, Kiel, 24118, Germany.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Schwarz', 'Affiliation': 'University of Kiel, Department of Food Technology, University of Kiel, Kiel, 24118, Germany.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Laudes', 'Affiliation': 'Division of Endocrinology, Diabetes and Clinical Nutrition, Department of Internal Medicine 1, University Hospital Schleswig-Holstein, Campus Kiel, University of Kiel, Kiel, 24105, Germany. Electronic address: matthias.laudes@uksh.de.'}]","Clinical nutrition (Edinburgh, Scotland)",['10.1016/j.clnu.2020.06.006'] 2373,32600866,Tooth discoloration and the effects of internal bleaching on the novel endodontic filling material SavDen® MTA.,"BACKGROUND/PURPOSE Mineral trioxide aggregate (MTA) was widely used in endodontic therapy as bioceramic material. Although MTA has high biocompatibility, it may lead to tooth discoloration. The aim of this study was to investigate the discoloration of two different bioceramic materials and the effects of internal bleaching. METHODS Thirty single-canal mandibular premolars were extracted and randomly assigned to three groups (n = 10), white ProRoot® MTA, SavDen® MTA and a control group. Endodontic access opening, cleaning and shaping were performed, then the teeth were obturated using the two bioceramic materials. Tooth color was recorded at baseline, day 1, and 1, 2, 4, 6, 8, 12, 16, and 24 weeks after treatment. At the end of 24 weeks, sodium perborate was used to perform internal bleaching. Tooth color was recorded at 1, 2, and 6 weeks subsequently. Teeth were measured using a DeguDent® spectrophotometer, and data were transformed into Commission Internationale de l'Eclairage (CIE) L∗a∗b∗ system. RESULTS Teeth treated with white ProRoot® MTA showed significant color change and decrease in L∗ value. Internal bleaching leaded to decrease of the ΔE∗ value for all three groups and increase in the L∗ value. There was no difference in tooth discoloration between SavDen® MTA and the control group after obturation and internal bleaching. CONCLUSION In terms of visual perception, white ProRoot® MTA tends to cause black and blue discoloration. SavDen® MTA, formulated with calcium lactate gluconate, could be used to reduce tooth discoloration in endodontic treatment.",2020,"There was no difference in tooth discoloration between SavDen® MTA and the control group after obturation and internal bleaching. ",['Thirty single-canal mandibular premolars'],"['internal bleaching', 'calcium lactate gluconate', 'white ProRoot® MTA, SavDen® MTA and a control group', 'MTA', 'Mineral trioxide aggregate (MTA', 'white ProRoot® MTA']","['L∗ value', 'tooth discoloration', 'Tooth color']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0222756', 'cui_str': 'Structure of mandibular canal'}, {'cui': 'C1704302', 'cui_str': 'Structure of premolar tooth'}]","[{'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0771535', 'cui_str': 'calcium lactate gluconate'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C1098459', 'cui_str': 'aggregate ProRoot'}, {'cui': 'C0253527', 'cui_str': 'mineral trioxide aggregate'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0040434', 'cui_str': 'Staining of tooth'}, {'cui': 'C0475833', 'cui_str': 'Tooth color'}]",30.0,0.0169253,"There was no difference in tooth discoloration between SavDen® MTA and the control group after obturation and internal bleaching. ","[{'ForeName': 'Wan-Chun', 'Initials': 'WC', 'LastName': 'Yang', 'Affiliation': 'School of Dentistry, College of Oral Medicine, Taipei Medical University, Taipei, Taiwan; Dental Department of Wan-Fang Hospital, Taipei Medical University, Taipei, Taiwan.'}, {'ForeName': 'Liang-Yi', 'Initials': 'LY', 'LastName': 'Tsai', 'Affiliation': 'Dental Department of Wan-Fang Hospital, Taipei Medical University, Taipei, Taiwan.'}, {'ForeName': 'Yung-Hao', 'Initials': 'YH', 'LastName': 'Hsu', 'Affiliation': 'School of Dentistry, College of Oral Medicine, Taipei Medical University, Taipei, Taiwan; Dental Department of Wan-Fang Hospital, Taipei Medical University, Taipei, Taiwan.'}, {'ForeName': 'Nai-Chia', 'Initials': 'NC', 'LastName': 'Teng', 'Affiliation': 'School of Dentistry, College of Oral Medicine, Taipei Medical University, Taipei, Taiwan.'}, {'ForeName': 'Jen-Chang', 'Initials': 'JC', 'LastName': 'Yang', 'Affiliation': 'Graduate Institute of Nanomedicine and Medical Engineering, College of Biomedical Engineering, Taipei Medical University, Taipei, Taiwan.'}, {'ForeName': 'Sung-Chih', 'Initials': 'SC', 'LastName': 'Hsieh', 'Affiliation': 'School of Dentistry, College of Oral Medicine, Taipei Medical University, Taipei, Taiwan; Dental Department of Wan-Fang Hospital, Taipei Medical University, Taipei, Taiwan. Electronic address: endo@tmu.edu.tw.'}]",Journal of the Formosan Medical Association = Taiwan yi zhi,['10.1016/j.jfma.2020.06.016'] 2374,32600870,Treatment Efficacy of Voice Therapy Following Injection Laryngoplasty for Unilateral Vocal Fold Paralysis.,"OBJECTIVES Injection laryngoplasty (IL) is performed to reduce the gap between vocal folds induced by unilateral vocal fold paralysis (UVFP). Voice quality after IL may be different due to other factors that influence voice quality. Voice therapy has been reported to improve voice quality after IL in patients with UVFP. This study evaluated the efficacy of voice therapy combined with IL. METHODS Patients with UVFP who underwent IL as primary therapy from March 2017 to June 2019 were evaluated. The enrolled patients were divided into two groups, those who did and did not receive voice therapy after IL. Voice quality was evaluated using perceptual, acoustic, and aerodynamic parameters, and voice handicap index-30 scores one month after IL and after completing each treatment. RESULTS Of 261 patients who underwent IL during the study period, 40 were enrolled, including 21 who did and 19 who did not receive voice therapy. Voice parameters one month after IL did not differ between these two groups. Jitter, shimmer, noise-to-harmonic ratio, and mean flow rate decreased, while maximum phonation time increased after voice therapy (both P < 0.05). In the absence of voice therapy, improved voice parameters were maintained for six months after IL. Total voice handicap index-30 scores decreased, from 35.6 to 19.1 (P < 0.05), in patients who received voice therapy. CONCLUSION Voice therapy following IL is beneficial to patients with UVFP. Combined treatment can help to maintain improved voice quality more than six months after IL.",2020,"Total voice handicap index-30 scores decreased, from 35.6 to 19.1 (P < 0.05), in patients who received voice therapy. ","['261 patients who underwent IL during the study period, 40 were enrolled, including 21 who did and 19 who did not receive voice therapy', 'Patients with UVFP who underwent IL as primary therapy from March 2017 to June 2019 were evaluated', 'patients with UVFP', 'Unilateral Vocal Fold Paralysis']","['voice therapy combined with IL', 'Voice Therapy', 'Injection laryngoplasty (IL', 'voice therapy', 'Voice therapy']","['Voice quality', 'voice quality', 'voice parameters', 'perceptual, acoustic, and aerodynamic parameters, and voice handicap index-30 scores', 'Total voice handicap index-30 scores', 'maximum phonation time', 'Jitter, shimmer, noise-to-harmonic ratio, and mean flow rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0189299', 'cui_str': 'Repair of larynx'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C2202690', 'cui_str': 'Voice therapy'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0042930', 'cui_str': 'Vocal cord structure'}, {'cui': 'C0237766', 'cui_str': 'Hysterical paralysis'}, {'cui': 'C1708063', 'cui_str': 'First line treatment'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}]","[{'cui': 'C2202690', 'cui_str': 'Voice therapy'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0189299', 'cui_str': 'Repair of larynx'}]","[{'cui': 'C0042943', 'cui_str': 'Vocal quality'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0001166', 'cui_str': 'Acoustics'}, {'cui': 'C2985106', 'cui_str': 'Voice handicap index'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0234778', 'cui_str': 'Maximum phonation time'}, {'cui': 'C0028263', 'cui_str': 'Noise'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",40.0,0.0166216,"Total voice handicap index-30 scores decreased, from 35.6 to 19.1 (P < 0.05), in patients who received voice therapy. ","[{'ForeName': 'Go-Eun', 'Initials': 'GE', 'LastName': 'Jeong', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Asan Medical Center, University of Ulsan of Medicine.'}, {'ForeName': 'Dam Hee', 'Initials': 'DH', 'LastName': 'Lee', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Asan Medical Center, University of Ulsan of Medicine.'}, {'ForeName': 'Yoon Se', 'Initials': 'YS', 'LastName': 'Lee', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Asan Medical Center, University of Ulsan of Medicine. Electronic address: manseilee@gmail.com.'}, {'ForeName': 'Dae Seong', 'Initials': 'DS', 'LastName': 'Ahn', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Asan Medical Center, University of Ulsan of Medicine.'}, {'ForeName': 'Dong Kyu', 'Initials': 'DK', 'LastName': 'Lee', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Asan Medical Center, University of Ulsan of Medicine.'}, {'ForeName': 'Seung-Ho', 'Initials': 'SH', 'LastName': 'Choi', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Asan Medical Center, University of Ulsan of Medicine.'}, {'ForeName': 'Soon Yuhl', 'Initials': 'SY', 'LastName': 'Nam', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Asan Medical Center, University of Ulsan of Medicine.'}, {'ForeName': 'Sang Yoon', 'Initials': 'SY', 'LastName': 'Kim', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Asan Medical Center, University of Ulsan of Medicine.'}]",Journal of voice : official journal of the Voice Foundation,['10.1016/j.jvoice.2020.05.014'] 2375,32600891,Use of a Secure Web-Based Data Management Platform to Track Resident Operative Performance and Program Educational Quality Over Time.,"OBJECTIVE In surgery residency programs, Accreditation Council for Graduate Medical Education mandated performance assessment can include assessment in the operating room to demonstrate that necessary quality and autonomy goals are achieved by the conclusion of training. For the past 3 years, our institution has used The Ottawa Surgical Competency Operating Room Evaluation (O-SCORE) instrument to assess and track operative skills. Evaluation is accomplished in near real-time using a secure web-based platform for data management and analytics (Firefly). Simultaneous to access of the platform's case logging function, the O-SCORE instrument is delivered to faculty members for rapid completion, facilitating quality, and timeliness of feedback. We sought to demonstrate the platform's utility in detecting operative performance changes over time in response to focused educational interventions based on stored case log and O-SCORE data. DESIGN Stored resident performance assessments for the most frequently performed laparoscopic procedures (cholecystectomy, appendectomy, inguinal hernia repair, ventral hernia repair) were examined for 3 successive academic years (2016-2019). During this time, 4 of 36 residents had received program-assigned supplemental simulation training to improve laparoscopic skills. O-SCORE data for these residents were extracted from peer data, which were used for comparisons. Assigned training consisted of a range of videoscopic and virtual reality skills drills with performance objectives. O-SCORE responses were converted to integers and autonomy scores for items pertaining to technical skill were compared before and after educational interventions (Student's t-tests). These scores were also compared to aggregate scores in the nonintervention group. Bayesian-modeled learning curves were used to characterize patterns of improvement over time. SETTING University of Massachusetts Medical School-Baystate Surgery Residency and Baystate Medical Center PARTICIPANTS: General surgery residents (n = 36) RESULTS: During the period of review, 3325 resident cases were identified meeting the case type criteria. As expected, overall autonomy increased with the number of cases performed. The 4 residents who had been assigned supplemental training (6-18 months) had preintervention score averages that were lower than that of the nonintervention group (2.25 ± 0.43 vs 3.57 ± 1.02; p < 0.0001). During the respective intervention periods, all 4 residents improved autonomy scores (increase to 3.40 ± 0.61; p < 0.0001). Similar improvements were observed for tissue handling, instrument handling, bimanual dexterity, visuospatial skill, and operative efficiency component skills. Postintervention scores were not significantly different compared to scores for the non-intervention group. Bayesian-modeled learning curves showed a similar pattern of postintervention performance improvement. CONCLUSIONS The data management platform proved to be an effective tool to track responses to supplemental training that was deemed necessary to close defined skills gaps in laparoscopic surgery. This could be seen both in individual and in aggregated data. We were gratified that at the conclusion of the supplemental training, O-SCORE results for the intervention group were not different than those seen in the non-intervention group.",2020,"Similar improvements were observed for tissue handling, instrument handling, bimanual dexterity, visuospatial skill, and operative efficiency component skills.","['36 residents had received', 'University of Massachusetts Medical School-Baystate Surgery Residency and Baystate Medical Center PARTICIPANTS: General surgery residents (n\u202f=\u202f36', '3325 resident cases were identified meeting the case type criteria']","['program-assigned supplemental simulation training', 'laparoscopic procedures (cholecystectomy, appendectomy, inguinal hernia repair, ventral hernia repair']","['Postintervention scores', 'autonomy scores', 'overall autonomy', 'O-SCORE responses', 'tissue handling, instrument handling, bimanual dexterity, visuospatial skill, and operative efficiency component skills', 'preintervention score averages']","[{'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0024874', 'cui_str': 'Massachusetts'}, {'cui': 'C0036378', 'cui_str': 'Medical School'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0035182', 'cui_str': 'Residency'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C1274039', 'cui_str': 'General surgery'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C4042947', 'cui_str': 'Simulation Training'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0008320', 'cui_str': 'Cholecystectomy'}, {'cui': 'C0003611', 'cui_str': 'Appendectomy'}, {'cui': 'C0021446', 'cui_str': 'Repair of inguinal hernia'}, {'cui': 'C0019334', 'cui_str': 'Repair of ventral hernia'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}, {'cui': 'C0565699', 'cui_str': 'Ability to perform general manipulative activities'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0449432', 'cui_str': 'Component'}]",,0.0374018,"Similar improvements were observed for tissue handling, instrument handling, bimanual dexterity, visuospatial skill, and operative efficiency component skills.","[{'ForeName': 'Adriana L', 'Initials': 'AL', 'LastName': 'Meholick', 'Affiliation': 'University of Massachusetts Medical School-Baystate, Department of Surgery, Springfield, Massachusetts.'}, {'ForeName': 'Jonathan L', 'Initials': 'JL', 'LastName': 'Jesneck', 'Affiliation': 'Firefly Lab, Cambridge, Massachusetts.'}, {'ForeName': 'Ruchi M', 'Initials': 'RM', 'LastName': 'Thanawala', 'Affiliation': 'Division of Cardiothoracic Surgery, University of Iowa Hospitals and Clinics, Iowa City, Iowa.'}, {'ForeName': 'Neal E', 'Initials': 'NE', 'LastName': 'Seymour', 'Affiliation': 'University of Massachusetts Medical School-Baystate, Department of Surgery, Springfield, Massachusetts. Electronic address: Neal.Seymour@baystatehealth.org.'}]",Journal of surgical education,['10.1016/j.jsurg.2020.05.022'] 2376,32607820,"Can Clinical and Functional Outcomes Be Improved with an Intelligent ""Internet Plus""-Based Full Disease Cycle Remote Ischemic Conditioning Program in Acute ST-elevation Myocardial Infarction Patients Undergoing Percutaneous Coronary Intervention? Rationale and Design of the i-RIC Trial.","BACKGROUND Acute ST-elevation myocardial infarction (STEMI) is associated with a high incidence of complications as well as a considerable hospitalization rate and economic burden. Preliminary evidence suggests that remote ischemic conditioning (RIC) is a promising non-invasive intervention that may effectively and safely reduce myocardial infarct size, subsequent cardiac events and complications, and mortality. However, RIC's cardio-protective effect remains under debate, especially for single timepoint RIC programs. Adequately powered large-scale randomized controlled trials investigating clinical outcomes are thus needed to clarify the role of full disease cycle RIC programs. METHODS The intelligent ""Internet Plus""-based full disease cycle remote ischemic conditioning (i-RIC) trial is a pragmatic, multicenter, randomized controlled, parallel group, clinical trial. The term, intelligent ""Internet Plus""-based full disease cycle, refers to smart devices aided automatic and real-time monitoring of remote ischemic pre-, per- or post-conditioning intervention for patients with STEMI undergoing percutaneous coronary intervention (PCI). Based on this perspective, 4700 STEMI patients from five hospitals in China will be randomized to a control and an intervention group. The control group will receive PCI and usual care, including pharmacotherapy, before and after PCI. The intervention group will receive pre-, per-, and post-operative RIC combined with long-term i-RIC over a one-month period in addition. A smartphone application, an automated cuff inflation/deflation device and ""Internet Plus""-based administration will be used in the long-term phase. The primary outcome is the combined cardiac death or hospitalization for heart failure rate. Secondary outcomes include clinical and functional outcomes: major adverse cardiac and cerebrovascular events rate, all-cause mortality, myocardial reinfarction rate, readmission rate for heart failure and ischemic stroke rate, unplanned revascularization rate, plasma concentration of myocardial infarction-related key biomarkers, infarct size, cardiac function, cardiopulmonary endurance, health-related quality of life, total hospital length of stay, total medical cost, and compliance with treatment regime. DISCUSSION The i-RIC trial is designed to test the hypothesis that clinical and functional outcomes can be improved with the i-RIC program in STEMI patients undergoing PCI. The concept of RIC is expected to be enhanced with this intelligent ""Internet Plus""-based program focusing on the full disease cycle. If the i-RIC program results in superior improvement in primary and secondary outcomes, it will offer an innovative treatment option for STEMI patients and form the basis of future recommendations. CLINICAL TRIAL REGISTRATION Chinese Clinical Trial Registry ( http://www.chictr.org.cn ): ChiCTR2000031550, 04 April 2020.",2020,"If the i-RIC program results in superior improvement in primary and secondary outcomes, it will offer an innovative treatment option for STEMI patients and form the basis of future recommendations. ","['The intelligent ""Internet Plus""-based full disease cycle remote ischemic conditioning', 'patients with STEMI undergoing percutaneous coronary intervention (PCI', '4700 STEMI patients from five hospitals in China', 'STEMI patients undergoing PCI', 'Acute ST-elevation Myocardial Infarction Patients Undergoing Percutaneous Coronary Intervention']","['Plus""-Based Full Disease Cycle Remote Ischemic Conditioning Program', 'Intelligent ""Internet', 'remote ischemic conditioning (RIC', 'pre-, per-, and post-operative RIC combined with long-term i-RIC']","['clinical and functional outcomes: major adverse cardiac and cerebrovascular events rate, all-cause mortality, myocardial reinfarction rate, readmission rate for heart failure and ischemic stroke rate, unplanned revascularization rate, plasma concentration of myocardial infarction-related key biomarkers, infarct size, cardiac function, cardiopulmonary endurance, health-related quality of life, total hospital length of stay, total medical cost, and compliance with treatment regime', 'combined cardiac death or hospitalization for heart failure rate']","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1303258', 'cui_str': 'Acute ST segment elevation myocardial infarction'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}]","[{'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0475224', 'cui_str': 'Ischemic'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0948369', 'cui_str': 'Myocardial reinfarction'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0021308', 'cui_str': 'Infarct'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0232164', 'cui_str': 'Cardiac function'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C1321605', 'cui_str': 'Compliance behavior'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0376297', 'cui_str': 'Cardiac death'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}]",4700.0,0.129771,"If the i-RIC program results in superior improvement in primary and secondary outcomes, it will offer an innovative treatment option for STEMI patients and form the basis of future recommendations. ","[{'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Zheng', 'Affiliation': 'Department of Rehabilitation Medicine, The First Affiliated Hospital of Nanjing Medical University, No.300 Guangzhou Road, Nanjing, 210029, China.'}, {'ForeName': 'Jan D', 'Initials': 'JD', 'LastName': 'Reinhardt', 'Affiliation': 'Institute for Disaster Management and Reconstruction of Sichuan University and Hongkong Polytechnic University, Chengdu, 610207, China.'}, {'ForeName': 'Jianan', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Department of Rehabilitation Medicine, The First Affiliated Hospital of Nanjing Medical University, No.300 Guangzhou Road, Nanjing, 210029, China.'}, {'ForeName': 'Dayi', 'Initials': 'D', 'LastName': 'Hu', 'Affiliation': ""Heart Centre, Peking University People's Hospital, Beijing, 100000, China.""}, {'ForeName': 'Song', 'Initials': 'S', 'LastName': 'Lin', 'Affiliation': 'Department of Cardiology, the Affiliated Nanjing First Hospital of Nanjing Medical University, Nanjing, 210029, China.'}, {'ForeName': 'Liansheng', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Department of Cardiology, The First Affiliated Hospital of Nanjing Medical University, Nanjing, 210029, China.'}, {'ForeName': 'Ruozhu', 'Initials': 'R', 'LastName': 'Dai', 'Affiliation': 'Department of Cardiology, Quanzhou First Hospital Affiliated to Fujian Medical University, Quanzhou, 362000, China.'}, {'ForeName': 'Zhiqing', 'Initials': 'Z', 'LastName': 'Fan', 'Affiliation': 'Department of Cardiology, Daqing Oilfield General Hospital, Daqing, 163001, China.'}, {'ForeName': 'Rongjing', 'Initials': 'R', 'LastName': 'Ding', 'Affiliation': ""Heart Centre, Peking University People's Hospital, Beijing, 100000, China.""}, {'ForeName': 'Leilei', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Department of Cardiology, The First Affiliated Hospital of Nanjing Medical University, Nanjing, 210029, China.'}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Yuan', 'Affiliation': 'Department of Cardiology, The First Affiliated Hospital of Nanjing Medical University, Nanjing, 210029, China.'}, {'ForeName': 'Zhihui', 'Initials': 'Z', 'LastName': 'Xu', 'Affiliation': 'Department of Cardiology, The First Affiliated Hospital of Nanjing Medical University, Nanjing, 210029, China.'}, {'ForeName': 'Yihui', 'Initials': 'Y', 'LastName': 'Cheng', 'Affiliation': 'Department of Rehabilitation Medicine, The First Affiliated Hospital of Nanjing Medical University, No.300 Guangzhou Road, Nanjing, 210029, China.'}, {'ForeName': 'Chengjie', 'Initials': 'C', 'LastName': 'Yan', 'Affiliation': 'Department of Rehabilitation Medicine, The First Affiliated Hospital of Nanjing Medical University, No.300 Guangzhou Road, Nanjing, 210029, China.'}, {'ForeName': 'Xintong', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Department of Rehabilitation Medicine, The First Affiliated Hospital of Nanjing Medical University, No.300 Guangzhou Road, Nanjing, 210029, China.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Department of Rehabilitation Medicine, The First Affiliated Hospital of Nanjing Medical University, No.300 Guangzhou Road, Nanjing, 210029, China.'}, {'ForeName': 'Xiu', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Department of Rehabilitation Medicine, The First Affiliated Hospital of Nanjing Medical University, No.300 Guangzhou Road, Nanjing, 210029, China.'}, {'ForeName': 'Meiling', 'Initials': 'M', 'LastName': 'Teng', 'Affiliation': 'Department of Rehabilitation Medicine, The First Affiliated Hospital of Nanjing Medical University, No.300 Guangzhou Road, Nanjing, 210029, China.'}, {'ForeName': 'Qiuyu', 'Initials': 'Q', 'LastName': 'Yu', 'Affiliation': 'Department of Rehabilitation Medicine, The First Affiliated Hospital of Nanjing Medical University, No.300 Guangzhou Road, Nanjing, 210029, China.'}, {'ForeName': 'Aimei', 'Initials': 'A', 'LastName': 'Yin', 'Affiliation': 'Department of Rehabilitation Medicine, The First Affiliated Hospital of Nanjing Medical University, No.300 Guangzhou Road, Nanjing, 210029, China.'}, {'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'Lu', 'Affiliation': 'Department of Rehabilitation Medicine, The First Affiliated Hospital of Nanjing Medical University, No.300 Guangzhou Road, Nanjing, 210029, China. luxiao1972@163.com.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Cardiovascular drugs and therapy,['10.1007/s10557-020-07022-9'] 2377,32607917,"Sexual Health of Rural and Urban Young Male Couples in the United States: Differences in HIV Testing, Pre-exposure Prophylaxis Use, and Condom Use.","Young men who have sex with men (YMSM) are disproportionally affected by HIV, and main partnerships account for a large proportion of new HIV infections. HIV prevention is largely focused on urban YMSM, and less is known about sexual health of rural male couples. The present study used data from a randomized controlled trial of a relationship education and HIV prevention program for male couples to test associations of rurality with HIV/STI testing, PrEP use, number of sexual partners, and condomless anal sex (CAS) acts. Participants were 430 YMSM in relationships. Rural YMSM were less likely to have been tested for HIV/STIs, and to have used PrEP, compared to urban YMSM. Although higher rurality was associated with fewer CAS acts, CAS was not infrequent among rural YMSM, highlighting the need for increased HIV prevention geared toward young male couples living in rural, less resourced areas.",2020,"Rural YMSM were less likely to have been tested for HIV/STIs, and to have used PrEP, compared to urban YMSM.","['Young men who have sex with men (YMSM', 'male couples to test associations of rurality with HIV/STI testing, PrEP use, number of sexual partners, and condomless anal sex (CAS) acts', 'rural male couples', 'Sexual Health of Rural and Urban Young Male Couples']",['relationship education and HIV prevention program'],[],"[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0036916', 'cui_str': 'Sexually transmitted infectious disease'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0556463', 'cui_str': 'Number of sexual partners'}, {'cui': 'C0282347', 'cui_str': 'Anal sex'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C2362326', 'cui_str': 'Sexual Health'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}]","[{'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]",[],,0.0747052,"Rural YMSM were less likely to have been tested for HIV/STIs, and to have used PrEP, compared to urban YMSM.","[{'ForeName': 'Elissa L', 'Initials': 'EL', 'LastName': 'Sarno', 'Affiliation': 'Institute for Sexual and Gender Minority Health and Wellbeing, Department of Medical Social Sciences, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA. elissa.sarno@northwestern.edu.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Bettin', 'Affiliation': 'Institute for Sexual and Gender Minority Health and Wellbeing, Department of Medical Social Sciences, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.'}, {'ForeName': 'Kyle', 'Initials': 'K', 'LastName': 'Jozsa', 'Affiliation': 'Institute for Sexual and Gender Minority Health and Wellbeing, Department of Medical Social Sciences, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Newcomb', 'Affiliation': 'Institute for Sexual and Gender Minority Health and Wellbeing, Department of Medical Social Sciences, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.'}]",AIDS and behavior,['10.1007/s10461-020-02961-8'] 2378,32607949,The efficacy and mechanism for action of iguratimod in primary Sjögren's syndrome patients.,"PURPOSE Primary Sjögren's syndrome (pSS) has been proven as a systemic autoimmune disorder (such as Sjogren's syndrome dry eye). This research aimed to evaluate potential treating effects of Iguratimod on pSS. METHODS Fifty pSS patients were enrolled and randomly divided into Conventional group and Iguratimod group. Improvement in pSS was evaluated every 4 weeks. pSS disease activity was evaluated with European League Against Rheumatism (EULAR) Sjögren's syndrome disease activity index (ESSDAI). Symptoms were evaluated by determining EULAR Sjögren's syndrome patient-reported index (ESSPRI), platelet (PLT), IgG and Schirmer I test. Peripheral blood B cell molecules (CD135, IgD, CD38, CD20) and human B cell-activating factor-receptor (BAFF-R) were analyzed with flow cytometry. RESULTS After treating for 12-weeks, pSS patients in Iguratimod and Conventional group showed a significant decrease in disease activity (ESSPRI, ESSDAI, PLT, IgG and Schirmer I test) comparing with baselines. Patients' ESSPRI (2.92 ± 0.19) and disease activity of ESSDAI (4.32 ± 0.29), PLT (95.64 ± 1.86), IgG (13.0 ± 0.45) and Schirmer I test (4.67 ± 0.31) in Iguratimod group were significantly lower compared to Conventional group (4.64 ± 0.15, 5.8 ± 2.08, 77.44 ± 1.41, 16.5 ± 0.44 and 2.25 ± 0.11) (p < 0.0001). Changes of ESSPRI, ESSDAI, PLT, IgG and Schirmer I test were remarkable observed between two groups (p < 0.001). Iguratimod and Conventional treatment demonstrated a significant reduction in total B cells in pSS patients compared with pre-treatment. The pSS patients from Iguratimod and Conventional group showed a significant decreased BAFF-R (61.82 ± 1.52, 74.07 ± 1.11) and CD38 + IgD + (48.08 ± 0.92, 62.66 ± 1.12) on B cells after treatment compared with baseline (92.26 ± 0.32, 91.53 ± 0.45, 84.39 ± 0.59, 85.04 ± 0.46) (p < 0.001). After treating 12 weeks, BAFF-R, CD38 + IgD + expression in Iguratimod group decreased significantly compared to Conventional group (p < 0.001). CONCLUSIONS Iguratimod alleviated symptoms and mediated adaptive-immunity balance by suppressing BAFF-R positive B cell in pSS patients.",2020,Iguratimod and Conventional treatment demonstrated a significant reduction in total B cells in pSS patients compared with pre-treatment.,"['pSS patients', ""Primary Sjögren's syndrome (pSS"", 'Fifty pSS patients', ""primary Sjögren's syndrome patients""]","['Conventional group and Iguratimod group', 'pSS']","['disease activity', ""Sjögren's syndrome disease activity index (ESSDAI"", 'disease activity of ESSDAI', 'total B cells', 'BAFF-R, CD38 + IgD + expression', ""EULAR Sjögren's syndrome patient-reported index (ESSPRI), platelet (PLT), IgG and Schirmer"", 'Peripheral blood B cell molecules (CD135, IgD, CD38, CD20) and human B cell-activating factor-receptor (BAFF-R', 'disease activity (ESSPRI, ESSDAI, PLT, IgG and Schirmer', 'BAFF-R', 'European League Against Rheumatism (EULAR', 'Changes of ESSPRI, ESSDAI, PLT, IgG and Schirmer']","[{'cui': 'C0151449', 'cui_str': ""Primary Sjögren's syndrome""}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1872427', 'cui_str': 'iguratimod'}, {'cui': 'C0151449', 'cui_str': ""Primary Sjögren's syndrome""}]","[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C1527336', 'cui_str': ""Sjögren's syndrome""}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0004561', 'cui_str': 'B lymphocyte'}, {'cui': 'C1384654', 'cui_str': 'TNFRSF13C protein, human'}, {'cui': 'C0075742', 'cui_str': 'Lymphocyte antigen CD38'}, {'cui': 'C0020843', 'cui_str': 'Immunoglobulin D'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0009326', 'cui_str': 'Collagen disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0005821', 'cui_str': 'thrombocytes'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood'}, {'cui': 'C0567416', 'cui_str': 'Molecule'}, {'cui': 'C0054946', 'cui_str': 'Lymphocyte antigen CD20'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",50.0,0.0365604,Iguratimod and Conventional treatment demonstrated a significant reduction in total B cells in pSS patients compared with pre-treatment.,"[{'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Jiang', 'Affiliation': ""Department of Integrated Traditional Chinese and Western Medicine, The Ninth People's Hospital of Chongqing, Chongqing, China.""}, {'ForeName': 'Lingshu', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Department of Rheumatology and Immunology, West China Hospital, Sichuan University, No. 37 Guoxue Lane, Wuhou District, Chengdu, 610041, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'Department of Rheumatology and Immunology, West China Hospital, Sichuan University, No. 37 Guoxue Lane, Wuhou District, Chengdu, 610041, China.'}, {'ForeName': 'Xiong', 'Initials': 'X', 'LastName': 'He', 'Affiliation': ""Department of Integrated Traditional Chinese and Western Medicine, The Ninth People's Hospital of Chongqing, Chongqing, China.""}, {'ForeName': 'Chunrong', 'Initials': 'C', 'LastName': 'Hu', 'Affiliation': ""Department of Integrated Traditional Chinese and Western Medicine, The Ninth People's Hospital of Chongqing, Chongqing, China.""}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Rheumatology and Immunology, West China Hospital, Sichuan University, No. 37 Guoxue Lane, Wuhou District, Chengdu, 610041, China. Liuyi2020huaxi@163.com.'}]",International ophthalmology,['10.1007/s10792-020-01490-6'] 2379,32607967,Baseline Characteristics and Outcomes Among Patients with Complicated Skin and Soft Tissue Infections Admitted to the Intensive Care Unit: Analysis of the Phase 3 COVERS Randomized Trial of Ceftaroline Fosamil Versus Vancomycin Plus Aztreonam.,"AIM Exploratory analyses evaluated patient characteristics and outcomes among patients with complicated skin and soft tissue infection (cSSTI) in the phase 3 COVERS study who were admitted to an intensive care unit (ICU). METHODS Adults with cSSTI (surface area ≥ 75 cm 2 ) and evidence of systemic inflammation and/or underlying comorbidities were randomized 2:1 to intravenous ceftaroline fosamil (600 mg every 8 h [q8h]) or vancomycin (15 mg/kg every 12 h) plus aztreonam (1 g q8h) for 5-14 days. Clinical response and ICU length of stay (LOS) within first hospitalization were evaluated in the modified intent-to-treat (MITT) and clinically evaluable (CE) populations; a Cox proportional hazards model identified factors associated with increased hospital LOS. RESULTS Overall, 42 of 761 randomized patients were admitted to the ICU (ceftaroline fosamil, n = 32; vancomycin plus aztreonam, n = 10) prior to, or at start of, study treatment. Baseline differences between the ICU and non-ICU populations were indicative of more severe disease in ICU patients; within this subset, there were also some notable imbalances between treatment groups. Clinical cure rates at test-of-cure (ceftaroline fosamil vs. vancomycin plus aztreonam) were generally similar in the non-ICU and ICU subsets (MITT population 79% vs. 79% and 69% vs. 90.0%, respectively; CE population 87% vs. 85% and 80% vs. 89%, respectively). Median ICU LOS was 8 vs. 13 days, respectively. ICU admission was a risk factor predicting increased hospital LOS (P < 0.001). CONCLUSIONS Clinical outcomes for patients admitted to the ICU were generally similar to non-ICU patients, despite more severe baseline disease, with shorter median treatment duration in the ceftaroline fosamil group. ICU admission was associated with longer hospital LOS. Given the small sample size and unbalanced patient and disease characteristics within the ICU subgroup, differences between treatment groups should be interpreted with caution. TRIAL REGISTRATION ClinicalTrials.gov identifier, NCT01499277.",2020,"ICU admission was a risk factor predicting increased hospital LOS (P < 0.001). ","['42 of 761 randomized patients were admitted to the ICU (ceftaroline fosamil, n\u2009=\u200932', ' n\u2009=\u200910) prior to, or at start of, study treatment', 'Patients with Complicated Skin and Soft Tissue Infections Admitted to the Intensive Care Unit', 'Adults with cSSTI (surface area\u2009≥\u200975 cm 2 ) and evidence of systemic inflammation and/or underlying comorbidities', 'patients with complicated skin and soft tissue infection (cSSTI) in the phase 3 COVERS study who were admitted to an intensive care unit (ICU']","['vancomycin plus aztreonam', 'vancomycin', 'aztreonam', 'intravenous ceftaroline fosamil', 'Ceftaroline Fosamil Versus Vancomycin Plus Aztreonam']","['hospital LOS', 'Clinical response and ICU length of stay (LOS', 'Clinical cure rates', 'Median ICU LOS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C2001525', 'cui_str': 'ceftaroline fosamil'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C4727978', 'cui_str': 'Complicated skin and soft tissue infection'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0332120', 'cui_str': 'Evidence of'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0282461', 'cui_str': 'Clinical Trials, Phase 3 as Topic'}, {'cui': 'C0439844', 'cui_str': 'Covered'}]","[{'cui': 'C0042313', 'cui_str': 'Vancomycin'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0004521', 'cui_str': 'Aztreonam'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C2001525', 'cui_str': 'ceftaroline fosamil'}]","[{'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",761.0,0.064208,"ICU admission was a risk factor predicting increased hospital LOS (P < 0.001). ","[{'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Sánchez-García', 'Affiliation': 'Hospital Clínico San Carlos, Calle del Prof Martín Lagos, Madrid, Spain. miguelsanchez.hcsc@gmail.com.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Hammond', 'Affiliation': 'Pfizer, Collegeville, PA, USA.'}, {'ForeName': 'Jean Li', 'Initials': 'JL', 'LastName': 'Yan', 'Affiliation': 'Pfizer, New York, NY, USA.'}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Kantecki', 'Affiliation': 'Pfizer, Paris, France.'}, {'ForeName': 'Wajeeha', 'Initials': 'W', 'LastName': 'Ansari', 'Affiliation': 'Pfizer, New York, NY, USA.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Dryden', 'Affiliation': 'Royal Hampshire County Hospital, Winchester, UK.'}]",Infectious diseases and therapy,['10.1007/s40121-020-00297-3'] 2380,32608341,Who Are the Mavens of Bystander Intervention? Implications for the Social Diffusion of Intervention Norms.,"A recent randomized controlled trial reported that Green Dot (GD)-a bystander intervention training program that targets popular opinion leaders for intensive training-reduced school-level interpersonal violence perpetration and victimization. Expanding GD's targeted group members to include ""mavens"" of bystander intervention-those who spread bystander intervention norms to others by communicating with peers-may increase the effectiveness of such training. Self-report data collected from students at the 13 intervention high schools in Kentucky are analyzed to identify characteristics of those who engage in discussions with peers about preventing interpersonal violence. Findings show that students who engage in more frequent bystander behaviors are more likely to have such conversations with peers, but GD participants were no more likely than nonparticipants to discuss preventing interpersonal violence with peers.",2020,"Findings show that students who engage in more frequent bystander behaviors are more likely to have such conversations with peers, but GD participants were no more likely than nonparticipants to discuss preventing interpersonal violence with peers.",['Self-report data collected from students at the 13 intervention high schools in Kentucky'],['Green Dot (GD)-a bystander intervention training program'],['interpersonal violence'],"[{'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0022557', 'cui_str': 'Kentucky'}]","[{'cui': 'C0332583', 'cui_str': 'Green color'}, {'cui': 'C1720485', 'cui_str': 'Corneal epithelial dots'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0042693', 'cui_str': 'Violence'}]",,0.0217257,"Findings show that students who engage in more frequent bystander behaviors are more likely to have such conversations with peers, but GD participants were no more likely than nonparticipants to discuss preventing interpersonal violence with peers.","[{'ForeName': 'Leah C', 'Initials': 'LC', 'LastName': 'Butler', 'Affiliation': 'University of Cincinnati, OH, USA.'}, {'ForeName': 'Bonnie S', 'Initials': 'BS', 'LastName': 'Fisher', 'Affiliation': 'University of Cincinnati, OH, USA.'}]",Journal of interpersonal violence,['10.1177/0886260520934431'] 2381,32608353,"A web-based, peer-supported self-management intervention to reduce distress in relatives of people with psychosis or bipolar disorder: the REACT RCT.","BACKGROUND Relatives caring for people with severe mental health problems find information and emotional support hard to access. Online support for self-management offers a potential solution. OBJECTIVE The objective was to determine the clinical effectiveness and cost-effectiveness of an online supported self-management tool for relatives: the Relatives' Education And Coping Toolkit (REACT). DESIGN AND SETTING This was a primarily online (UK), single-blind, randomised controlled trial, comparing REACT plus a resource directory and treatment as usual with the resource directory and treatment as usual only, by measuring user distress and other well-being measures at baseline and at 12 and 24 weeks. PARTICIPANTS A total of 800 relatives of people with severe mental health problems across the UK took part; relatives who were aged ≥ 16 years, were experiencing high levels of distress, had access to the internet and were actively seeking help were recruited. INTERVENTION REACT comprised 12 psychoeducation modules, peer support through a group forum, confidential messaging and a comprehensive resource directory of national support. Trained relatives moderated the forum and responded to messages. MAIN OUTCOME MEASURE The main outcome was the level of participants' distress, as measured by the General Health Questionnaire-28 items. RESULTS Various online and offline strategies, including social media, directed potential participants to the website. Participants were randomised to one of two arms: REACT plus the resource directory ( n  = 399) or the resource directory only ( n  = 401). Retention at 24 weeks was 75% (REACT arm, n  = 292; resource directory-only arm, n  = 307). The mean scores for the General Health Questionnaire-28 items reduced substantially across both arms over 24 weeks, from 40.2 (standard deviation 14.3) to 30.5 (standard deviation 15.6), with no significant difference between arms (mean difference -1.39, 95% confidence interval -3.60 to 0.83; p  = 0.22). At 12 weeks, the General Health Questionnaire-28 items scores were lower in the REACT arm than in the resource directory-only arm (-2.08, 95% confidence interval -4.14 to -0.03; p  = 0.027), but this finding is likely to be of limited clinical significance. Accounting for missing data, which were associated with higher distress in the REACT arm (0.33, 95% confidence interval -0.27 to 0.93; p  = 0.279), in a longitudinal model, there was no significant difference between arms over 24 weeks (-0.56, 95% confidence interval -2.34 to 1.22; p  = 0.51). REACT cost £142.95 per participant to design and deliver (£62.27 for delivery only), compared with £0.84 for the resource directory only. A health economic analysis of NHS, health and Personal Social Services outcomes found that REACT has higher costs (£286.77), slightly better General Health Questionnaire-28 items scores (incremental General Health Questionnaire-28 items score adjusted for baseline, age and gender: -1.152, 95% confidence interval -3.370 to 1.065) and slightly lower quality-adjusted life-year gains than the resource directory only; none of these differences was statistically significant. The median time spent online was 50.8 minutes (interquartile range 12.4-172.1 minutes) for REACT, with no significant association with outcome. Participants reported finding REACT a safe, confidential environment (96%) and reported feeling supported by the forum (89%) and the REACT supporters (86%). No serious adverse events were reported. LIMITATIONS The sample comprised predominantly white British females, 25% of participants were lost to follow-up and dropout in the REACT arm was not random. CONCLUSIONS An online self-management support toolkit with a moderated group forum is acceptable to relatives and, compared with face-to-face programmes, offers inexpensive, safe delivery of National Institute for Health and Care Excellence-recommended support to engage relatives as peers in care delivery. However, currently, REACT plus the resource directory is no more effective at reducing relatives' distress than the resource directory only. FUTURE WORK Further research in improving the effectiveness of online carer support interventions is required. TRIAL REGISTRATION Current Controlled Trials ISRCTN72019945. FUNDING This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment ; Vol. 24, No. 32. See the NIHR Journals Library website for further project information.",2020,"At 12 weeks, the General Health Questionnaire-28 items scores were lower in the REACT arm than in the resource directory-only arm (-2.08, 95% confidence interval -4.14 to -0.03; p  = 0.027), but this finding is likely to be of limited clinical significance.","['relatives of people with psychosis or bipolar disorder', 'Relatives caring for people with severe mental health problems', 'relatives', 'A total of 800 relatives of people with severe mental health problems across the UK took part; relatives who were aged ≥\u200916 years, were experiencing high levels of distress, had access to the internet and were actively seeking help were recruited']","['REACT plus the resource directory ( n \u2009=\u2009399) or the resource directory only', 'REACT', 'peer-supported self-management intervention']","['General Health Questionnaire-28 items scores (incremental General Health Questionnaire-28 items score', ""level of participants' distress, as measured by the General Health Questionnaire-28 items"", 'clinical effectiveness and cost-effectiveness', 'General Health Questionnaire-28 items scores', 'serious adverse events', 'median time spent online', 'mean scores for the General Health Questionnaire-28 items']","[{'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}, {'cui': 'C0005586', 'cui_str': 'Bipolar disorder'}, {'cui': 'C0578884', 'cui_str': 'Cares for a relative'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1446377', 'cui_str': 'Mental health problem'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C3844106', 'cui_str': '800'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}]","[{'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0282426', 'cui_str': 'Directories'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0451182', 'cui_str': 'General health questionnaire'}, {'cui': 'C0559741', 'cui_str': 'Item score'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C3850123', 'cui_str': 'Treatment Effectiveness'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",800.0,0.183323,"At 12 weeks, the General Health Questionnaire-28 items scores were lower in the REACT arm than in the resource directory-only arm (-2.08, 95% confidence interval -4.14 to -0.03; p  = 0.027), but this finding is likely to be of limited clinical significance.","[{'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Lobban', 'Affiliation': 'Spectrum Centre for Mental Health Research, Division of Health Research, Faculty of Health and Medicine, Lancaster University, Lancaster, UK.'}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Akers', 'Affiliation': 'Spectrum Centre for Mental Health Research, Division of Health Research, Faculty of Health and Medicine, Lancaster University, Lancaster, UK.'}, {'ForeName': 'Duncan', 'Initials': 'D', 'LastName': 'Appelbe', 'Affiliation': 'Clinical Trials Research Centre, Department of Biostatistics, University of Liverpool (a member of Liverpool Health Partners), Liverpool, UK.'}, {'ForeName': 'Rossella', 'Initials': 'R', 'LastName': 'Iraci Capuccinello', 'Affiliation': 'Division of Health Research, Faculty of Health and Medicine, Lancaster University, Lancaster, UK.'}, {'ForeName': 'Lesley', 'Initials': 'L', 'LastName': 'Chapman', 'Affiliation': 'Spectrum Centre for Mental Health Research, Division of Health Research, Faculty of Health and Medicine, Lancaster University, Lancaster, UK.'}, {'ForeName': 'Lizzi', 'Initials': 'L', 'LastName': 'Collinge', 'Affiliation': 'Spectrum Centre for Mental Health Research, Division of Health Research, Faculty of Health and Medicine, Lancaster University, Lancaster, UK.'}, {'ForeName': 'Susanna', 'Initials': 'S', 'LastName': 'Dodd', 'Affiliation': 'Clinical Trials Research Centre, Department of Biostatistics, University of Liverpool (a member of Liverpool Health Partners), Liverpool, UK.'}, {'ForeName': 'Sue', 'Initials': 'S', 'LastName': 'Flowers', 'Affiliation': 'Spectrum Centre for Mental Health Research, Division of Health Research, Faculty of Health and Medicine, Lancaster University, Lancaster, UK.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Hollingsworth', 'Affiliation': 'Division of Health Research, Faculty of Health and Medicine, Lancaster University, Lancaster, UK.'}, {'ForeName': 'Mahsa', 'Initials': 'M', 'LastName': 'Honary', 'Affiliation': 'Spectrum Centre for Mental Health Research, Division of Health Research, Faculty of Health and Medicine, Lancaster University, Lancaster, UK.'}, {'ForeName': 'Sonia', 'Initials': 'S', 'LastName': 'Johnson', 'Affiliation': 'Division of Psychiatry, University College London, London, UK.'}, {'ForeName': 'Steven H', 'Initials': 'SH', 'LastName': 'Jones', 'Affiliation': 'Spectrum Centre for Mental Health Research, Division of Health Research, Faculty of Health and Medicine, Lancaster University, Lancaster, UK.'}, {'ForeName': 'Ceu', 'Initials': 'C', 'LastName': 'Mateus', 'Affiliation': 'Division of Health Research, Faculty of Health and Medicine, Lancaster University, Lancaster, UK.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Mezes', 'Affiliation': 'Spectrum Centre for Mental Health Research, Division of Health Research, Faculty of Health and Medicine, Lancaster University, Lancaster, UK.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Murray', 'Affiliation': 'Research Department of Primary Care and Population Health, University College London, London, UK.'}, {'ForeName': 'Katerina', 'Initials': 'K', 'LastName': 'Panagaki', 'Affiliation': 'Spectrum Centre for Mental Health Research, Division of Health Research, Faculty of Health and Medicine, Lancaster University, Lancaster, UK.'}, {'ForeName': 'Naomi', 'Initials': 'N', 'LastName': 'Rainford', 'Affiliation': 'Clinical Trials Research Centre, Department of Biostatistics, University of Liverpool (a member of Liverpool Health Partners), Liverpool, UK.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Robinson', 'Affiliation': 'Spectrum Centre for Mental Health Research, Division of Health Research, Faculty of Health and Medicine, Lancaster University, Lancaster, UK.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Rosala-Hallas', 'Affiliation': 'Clinical Trials Research Centre, Department of Biostatistics, University of Liverpool (a member of Liverpool Health Partners), Liverpool, UK.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Sellwood', 'Affiliation': 'Division of Health Research, Faculty of Health and Medicine, Lancaster University, Lancaster, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Walker', 'Affiliation': 'Spectrum Centre for Mental Health Research, Division of Health Research, Faculty of Health and Medicine, Lancaster University, Lancaster, UK.'}, {'ForeName': 'Paula R', 'Initials': 'PR', 'LastName': 'Williamson', 'Affiliation': 'Clinical Trials Research Centre, Department of Biostatistics, University of Liverpool (a member of Liverpool Health Partners), Liverpool, UK.'}]","Health technology assessment (Winchester, England)",['10.3310/hta24320'] 2382,32608505,Psychological therapies for women who experience intimate partner violence.,"BACKGROUND Intimate partner violence (IPV) against women is prevalent and strongly associated with mental health problems. Women experiencing IPV attend health services frequently for mental health problems. The World Health Organization recommends that women who have experienced IPV and have a mental health diagnosis should receive evidence-based mental health treatments. However, it is not known if psychological therapies work for women in the context of IPV and whether they cause harm. OBJECTIVES To assess the effectiveness of psychological therapies for women who experience IPV on the primary outcomes of depression, self-efficacy and an indicator of harm (dropouts) at six- to 12-months' follow-up, and on secondary outcomes of other mental health symptoms, anxiety, quality of life, re-exposure to IPV, safety planning and behaviours, use of healthcare and IPV services, and social support. SEARCH METHODS We searched the Cochrane Common Mental Disorders Controlled Trials Register (CCMDCTR), CENTRAL, MEDLINE, Embase, CINAHL, PsycINFO, and three other databases, to the end of October 2019. We also searched international trials registries to identify unpublished or ongoing trials and handsearched selected journals, reference lists of included trials and grey literature. SELECTION CRITERIA We included randomised controlled trials (RCTs), quasi-RCTs, cluster-RCTs and cross-over trials of psychological therapies with women aged 16 years and older who self-reported recent or lifetime experience of IPV. We included trials if women also experienced co-existing mental health diagnoses or substance abuse issues, or both. Psychological therapies included a wide range of interventions that targeted cognition, motivation and behaviour compared with usual care, no treatment, delayed or minimal interventions. We classified psychological therapies according to Cochrane Common Mental Disorders's psychological therapies list. DATA COLLECTION AND ANALYSIS Two review authors extracted data and undertook 'Risk of Bias' assessment. Treatment effects were compared between experimental and comparator interventions at short-term (up to six months post-baseline), medium-term (six to under 12 months, primary outcome time point), and long-term follow-up (12 months and above). We used standardised mean difference (SMD) for continuous and odds ratio (OR) for dichotomous outcomes, and used random-effects meta-analysis, due to high heterogeneity across trials. MAIN RESULTS We included 33 psychological trials involving 5517 women randomly assigned to experimental (2798 women, 51%) and comparator interventions (2719 women, 49%). Psychological therapies included 11 integrative therapies, nine humanistic therapies, six cognitive behavioural therapy, four third-wave cognitive behavioural therapies and three other psychologically-orientated interventions. There were no trials classified as psychodynamic therapies. Most trials were from high-income countries (19 in USA, three in Iran, two each in Australia and Greece, and one trial each in China, India, Kenya, Nigeria, Pakistan, Spain and UK), among women recruited from healthcare, community, shelter or refuge settings, or a combination of any or all of these. Psychological therapies were mostly delivered face-to-face (28 trials), but varied by length of treatment (two to 50 sessions) and staff delivering therapies (social workers, nurses, psychologists, community health workers, family doctors, researchers). The average sample size was 82 women (14 to 479), aged 37 years on average, and 66% were unemployed. Half of the women were married or living with a partner and just over half of the participants had experienced IPV in the last 12 months (17 trials), 6% in the past two years (two trials) and 42% during their lifetime (14 trials). Whilst 20 trials (61%) described reliable low-risk random-sampling strategies, only 12 trials (36%) described reliable procedures to conceal the allocation of participant status. While 19 trials measured women's depression, only four trials measured depression as a continuous outcome at medium-term follow-up. These showed a probable beneficial effect of psychological therapies in reducing depression (SMD -0.24, 95% CI -0.47 to -0.01; four trials, 600 women; moderate-certainty evidence). However, for self-efficacy, there may be no evidence of a difference between groups (SMD -0.12, 95% CI -0.33 to 0.09; one trial with medium-term follow-up data, 346 women; low-certainty evidence). Further, there may be no difference between the number of women who dropped out from the experimental or comparator intervention groups, an indicator of no harm (OR 1.04, 95% CI 0.75 to 1.44; five trials with medium-term follow-up data, 840 women; low-certainty evidence). Although no trials reported adverse events from psychological therapies or participation in the trial, only one trial measured harm outcomes using a validated scale. For secondary outcomes, trials measured anxiety only at short-term follow-up, showing that psychological therapies may reduce anxiety symptoms (SMD -0.96, 95% CI -1.29 to -0.63; four trials, 158 women; low-certainty evidence). However, within medium-term follow-up, low-certainty evidence revealed that there may be no evidence between groups for the outcomes safety planning (SMD 0.04, 95% CI -0.18 to 0.25; one trial, 337 women), post-traumatic stress disorder (SMD -0.24, 95% CI -0.54 to 0.06; four trials, 484 women) or re-exposure to any form of IPV (SMD 0.03, 95% CI -0.14 to 0.2; two trials, 547 women). AUTHORS' CONCLUSIONS There is evidence that for women who experience IPV, psychological therapies probably reduce depression and may reduce anxiety. However, we are uncertain whether psychological therapies improve other outcomes (self-efficacy, post-traumatic stress disorder, re-exposure to IPV, safety planning) and there are limited data on harm. Thus, while psychological therapies probably improve emotional health, it is unclear if women's ongoing needs for safety, support and holistic healing from complex trauma are addressed by this approach. There is a need for more interventions focused on trauma approaches and more rigorous trials (with consistent outcomes at similar follow-up time points), as we were unable to synthesise much of the research.",2020,"These showed a probable beneficial effect of psychological therapies in reducing depression (SMD -0.24, 95% CI -0.47 to -0.01; four trials, 600 women; moderate-certainty evidence).","['women who experience intimate partner violence', 'women also experienced co-existing mental health diagnoses or substance abuse issues, or both', '82 women (14 to 479), aged 37 years on average, and 66% were unemployed', 'Intimate partner violence (IPV) against women', 'women who have experienced IPV and have a mental health diagnosis', '33 psychological trials involving 5517 women randomly assigned to experimental (2798 women, 51%) and comparator interventions (2719 women, 49', 'Most trials were from high-income countries (19 in USA, three in Iran, two each in Australia and Greece, and one trial each in China, India, Kenya, Nigeria, Pakistan, Spain and UK), among women recruited from healthcare, community, shelter or refuge settings, or a combination of any or all of these', 'Women experiencing IPV attend health services frequently for mental health problems', 'women aged 16 years and older who self-reported recent or lifetime experience of IPV']","['Psychological therapies included 11 integrative therapies, nine humanistic therapies, six cognitive behavioural therapy, four third-wave cognitive behavioural therapies and three other psychologically-orientated interventions', 'psychological therapies', 'Psychological therapies']","['anxiety symptoms', 'post-traumatic stress disorder', 'emotional health', 'mental health symptoms, anxiety, quality of life, re-exposure to IPV, safety planning and behaviours, use of healthcare and IPV services, and social support', 'IPV']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0740858', 'cui_str': 'Substance abuse'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0041674', 'cui_str': 'Unemployed'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0948433', 'cui_str': 'High income'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0022065', 'cui_str': 'Iran'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0018226', 'cui_str': 'Greece'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0022558', 'cui_str': 'Kenya'}, {'cui': 'C0028075', 'cui_str': 'Nigeria'}, {'cui': 'C0030211', 'cui_str': 'Pakistan'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0018747', 'cui_str': 'Services, Health'}, {'cui': 'C0332183', 'cui_str': 'Frequent'}, {'cui': 'C1446377', 'cui_str': 'Mental health problem'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0332185', 'cui_str': 'Recent'}]","[{'cui': 'C0841584', 'cui_str': 'Psychological therapies'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C4042876', 'cui_str': 'Intimate Partner Abuse'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0037438', 'cui_str': 'Social support'}]",5517.0,0.386411,"These showed a probable beneficial effect of psychological therapies in reducing depression (SMD -0.24, 95% CI -0.47 to -0.01; four trials, 600 women; moderate-certainty evidence).","[{'ForeName': 'Mohajer', 'Initials': 'M', 'LastName': 'Hameed', 'Affiliation': 'Department of General Practice, The University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Lorna', 'Initials': 'L', 'LastName': ""O'Doherty"", 'Affiliation': 'Faculty of Health and Life Sciences, Coventry University, Coventry, UK.'}, {'ForeName': 'Gail', 'Initials': 'G', 'LastName': 'Gilchrist', 'Affiliation': ""National Addiction Centre, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.""}, {'ForeName': 'Judit', 'Initials': 'J', 'LastName': 'Tirado-Muñoz', 'Affiliation': ""Addiction Research Group, IMIM-Institut Hospital del Mar d'Investigacions Mèdiques, Barcelona, Spain.""}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Taft', 'Affiliation': 'The Judith Lumley Centre, La Trobe University, Melbourne, Australia.'}, {'ForeName': 'Patty', 'Initials': 'P', 'LastName': 'Chondros', 'Affiliation': 'Department of General Practice, The University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Gene', 'Initials': 'G', 'LastName': 'Feder', 'Affiliation': 'Centre for Academic Primary Care, Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Tan', 'Affiliation': 'Department of General Practice, The University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Kelsey', 'Initials': 'K', 'LastName': 'Hegarty', 'Affiliation': 'Department of General Practice, The University of Melbourne, Melbourne, Australia.'}]",The Cochrane database of systematic reviews,['10.1002/14651858.CD013017.pub2'] 2383,32608554,Effects of mirror neuron system-based training on rehabilitation of stroke patients.,"OBJECTIVE To investigate the clinical effects of the mirror neuron system (MNS)-based training on upper extremity motor function and cognitive function in stroke patients. METHODS Sixty stroke patients (time from stroke onset 3-9 months) with upper extremity paresis (Brunnstrom stage II-IV) and cognitive impairment (MoCA score ≥ 15) were enrolled in this study. Patients were randomly allocated into MNS treatment group (N = 30) and control group (N = 30). Both groups underwent regular training for upper extremity motor function and cognitive function, and the MNS group was trained with a therapeutic apparatus named mirror neuron system training (MNST) including different levels of action observation training (AOT). Training lasted 20 min/day, 5 days/week for 8 weeks. MoCA, reaction time, and Wisconsin Card Sorting Test (WCST) were assessed at baseline and 8 weeks after training. Furthermore, Fugl-Meyer assessment (FMA) and Modified Barthel index (MBI) were adopted to evaluated upper extremity motor function and daily life ability. RESULTS After 8 consecutive weeks' training, both groups showed significant improvements on the upper extremity motor function, cognitive function, and daily life ability score after training (p < .05). The MNS group showed significantly improved upper extremity motor function and cognitive function (p < .05) compared with control group. CONCLUSIONS Combining MNS-based and conventional training can improve upper extremity motor function and cognitive function in stroke patients.",2020,"The MNS group showed significantly improved upper extremity motor function and cognitive function (p < .05) compared with control group. ","['stroke patients', 'Sixty stroke patients (time from stroke onset 3-9\xa0months) with upper extremity paresis (Brunnstrom stage II-IV) and cognitive impairment']","['mirror neuron system-based training', 'regular training', 'MNS group was trained with a therapeutic apparatus named mirror neuron system training (MNST) including different levels of action observation training (AOT', 'Combining MNS-based and conventional training', 'MNS', 'mirror neuron system (MNS)-based training']","['Furthermore, Fugl-Meyer assessment (FMA) and Modified Barthel index (MBI', 'upper extremity motor function and cognitive function', 'upper extremity motor function, cognitive function, and daily life ability score', 'MoCA, reaction time, and Wisconsin Card Sorting Test (WCST']","[{'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0751409', 'cui_str': 'Monoparesis - arm'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2'}, {'cui': 'C0338656', 'cui_str': 'Impaired cognition'}]","[{'cui': 'C3178760', 'cui_str': 'Mirror Neurons'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0243111', 'cui_str': 'apparatus'}, {'cui': 'C0027365', 'cui_str': 'Name'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0441472', 'cui_str': 'Action'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451019', 'cui_str': 'Barthel index'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0234130', 'cui_str': 'Motor function'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0025750', 'cui_str': ""3,3'-Dichloro-4,4'-Diaminodiphenylmethane""}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0451592', 'cui_str': 'Wisconsin card sorting test'}]",60.0,0.0126903,"The MNS group showed significantly improved upper extremity motor function and cognitive function (p < .05) compared with control group. ","[{'ForeName': 'Huiwen', 'Initials': 'H', 'LastName': 'Mao', 'Affiliation': 'Department of Rehabilitation Medicine, Tongren Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Rehabilitation Medicine, Tongren Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Tang', 'Affiliation': 'Department of Rehabilitation Medicine, Tongren Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Ye', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Department of Rehabilitation Medicine, Tongren Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Jiawei', 'Initials': 'J', 'LastName': 'Ni', 'Affiliation': 'Department of Rehabilitation Medicine, Tongren Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Department of Rehabilitation Medicine, Tongren Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.'}, {'ForeName': 'Chunlei', 'Initials': 'C', 'LastName': 'Shan', 'Affiliation': 'School of Rehabilitation Science and Institute of Rehabilitation Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, China.'}]",Brain and behavior,['10.1002/brb3.1729'] 2384,32608567,Re: Effect of preoperative pelvic floor muscle training on pelvic floor muscle contraction and symptomatic and anatomical pelvic organ prolapse after surgery: randomized controlled trial.,,2020,,['pelvic floor muscle contraction and symptomatic and anatomical pelvic organ prolapse after surgery'],['preoperative pelvic floor muscle training'],[],"[{'cui': 'C0206248', 'cui_str': 'Pelvic floor structure'}, {'cui': 'C0026820', 'cui_str': 'Muscle contraction'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0220784', 'cui_str': 'Anatomic'}, {'cui': 'C0877015', 'cui_str': 'Urogenital prolapse'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}]","[{'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C4087139', 'cui_str': 'Pelvic floor muscle training'}]",[],,0.044731,,"[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Vereeck', 'Affiliation': ""Department of Obstetrics and Gynecology, University Hospital of Antwerp (UZA), ASTARC, Women's Pelvic Health Antwerp, Faculty of Medicine and Health Sciences, University of Antwerp, Antwerp, Belgium.""}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Neels', 'Affiliation': ""Department of Obstetrics and Gynecology, University Hospital of Antwerp (UZA), ASTARC, Women's Pelvic Health Antwerp, Faculty of Medicine and Health Sciences, University of Antwerp, Antwerp, Belgium.""}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Govaerts', 'Affiliation': ""Department of Obstetrics and Gynecology, University Hospital of Antwerp (UZA), ASTARC, Women's Pelvic Health Antwerp, Faculty of Medicine and Health Sciences, University of Antwerp, Antwerp, Belgium.""}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Jacquemyn', 'Affiliation': ""Department of Obstetrics and Gynecology, University Hospital of Antwerp (UZA), ASTARC, Women's Pelvic Health Antwerp, Faculty of Medicine and Health Sciences, University of Antwerp, Antwerp, Belgium.""}]",Ultrasound in obstetrics & gynecology : the official journal of the International Society of Ultrasound in Obstetrics and Gynecology,['10.1002/uog.22113'] 2385,32609331,"Effect of Icosapent Ethyl on Progression of Coronary Atherosclerosis in Patients with Elevated Triglycerides on Statin Therapy: A prospective, placebo-controlled randomized trial (EVAPORATE): Interim Results.","AIMS Though statin therapy is known to slow coronary atherosclerosis progression and reduce cardiovascular(CV) events, significant CV risk still remains. In the REDUCE-IT study, icosapent ethyl (IPE) added to statin therapy reduced initial CV events by 25% and total CV events by 30%, but its effects on coronary atherosclerosis progression have not yet been fully investigated. Therefore, this study is to determine whether IPE 4g/d will result in a greater change from baseline in plaque volume measured by serial multidetector computed tomography (MDCT) than placebo in statin-treated patients. METHODS AND RESULTS EVAPORATE is a randomized, double-blind, placebo-controlled trial. Patients had to have coronary atherosclerosis by coronary computed tomographic angiography CCTA (≥1 angiographic stenoses with ≥20% narrowing), on stable statin therapy with low-density lipoprotein cholesterol levels 40 to 115 mg/dl, and persistently high triglyceride levels (135-499 mg/dL). Patients underwent an interim scan at 9 months and were followed for an additional 9 months with CCTA at 0, 9 and 18 months. Here we present the protocol-specified interim efficacy results.A total of 80 patients were enrolled, with 67 completing the 9-month visit and having interpretable CCTA at baseline and at 9-months (age=57±6 years, male=36, 63%). At the 9-month interim analysis, there was no significant change in low attenuation plaque (LAP) between active and placebo groups (74% vs 94%, p = 0.469). However, there was slowing of total non-calcified plaque (sum of LAP, fibrofatty, and fibrous plaque)(35% v. 43%,p=0.010), total plaque (non-calcified + calcified plaque)(15% v. 26%,p=0.0004), fibrous plaque (17% v. 40%,p=0.011) and calcified plaque (-1% v. 9%,p=0.001), after adjustment by baseline plaque, age, sex, diabetes, baseline triglyceride levels, and statin use. CONCLUSIONS EVAPORATE is the first study using CCTA to evaluate the effects of IPE as an adjunct to statin therapy on atherosclerotic plaque characteristics in a high-risk CV population with persistently high TG levels. It provides important mechanistic data in regards to the reduction in CV events in the REDUCE-IT clinical trial. TRANSLATIONAL POTENTIAL Given the robust cardiovascular event reduction seen in clinical trials of Icosapent ethyl, this study demonstrates that one potential mechanism of benefit of this therapy is to slow atherosclerosis progression. This study shows that most coronary plaque types show slowed rates of progression under the influence of statin plus Icosapent ethyl. A translational use of this information would be to potentially use this therapy in addition to statin therapy in cases with presence of significant atherosclerosis.",2020,"At the 9-month interim analysis, there was no significant change in low attenuation plaque (LAP) between active and placebo groups (74% vs 94%, p = 0.469).","['Patients had to have coronary atherosclerosis by coronary computed tomographic angiography CCTA (≥1 angiographic stenoses with ≥20% narrowing), on stable statin therapy with low-density lipoprotein cholesterol levels 40 to 115\u2009mg/dl, and persistently high triglyceride levels (135-499\u2009mg/dL', 'Patients with Elevated Triglycerides on Statin Therapy', 'A total of 80 patients were enrolled, with 67 completing the 9-month visit and having interpretable CCTA at baseline and at 9-months (age=57±6 years, male=36, 63']","['icosapent ethyl (IPE', 'Icosapent Ethyl', 'statin plus Icosapent ethyl', 'IPE', 'placebo']","['low attenuation plaque (LAP', 'slowing of total non-calcified plaque', 'Progression of Coronary Atherosclerosis', 'total plaque', 'calcified plaque', 'initial CV events', 'atherosclerotic plaque characteristics', 'coronary atherosclerosis progression', 'fibrous plaque']","[{'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C1536105', 'cui_str': 'CT angiography'}, {'cui': 'C0678234', 'cui_str': 'Form of stenosis'}, {'cui': 'C0332463', 'cui_str': 'Narrowed structure'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C1278454', 'cui_str': 'Statin prophylaxis'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement'}, {'cui': 'C0076769', 'cui_str': 'TO 115'}, {'cui': 'C0439269', 'cui_str': 'mg/dL'}, {'cui': 'C0020557', 'cui_str': 'Hypertriglyceridemia'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C4517566', 'cui_str': '135'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0058978', 'cui_str': 'icosapent ethyl'}, {'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332209', 'cui_str': 'Non-calcified'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C2936350', 'cui_str': 'Atherosclerotic Plaques'}, {'cui': 'C0334146', 'cui_str': 'Fibrous plaque'}]",80.0,0.161768,"At the 9-month interim analysis, there was no significant change in low attenuation plaque (LAP) between active and placebo groups (74% vs 94%, p = 0.469).","[{'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Budoff', 'Affiliation': 'Department of Medicine, Lundquist Institute at Harbor-UCLA Medical Center, Torrance CA.'}, {'ForeName': 'Joseph B', 'Initials': 'JB', 'LastName': 'Muhlestein', 'Affiliation': 'Intermountain Heart Institute, Intermountain Medical Center, Salt Lake City UT.'}, {'ForeName': 'Deepak L', 'Initials': 'DL', 'LastName': 'Bhatt', 'Affiliation': ""Brigham and Women's Hospital Heart & Vascular Center and Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Viet T', 'Initials': 'VT', 'LastName': 'Le Pa', 'Affiliation': 'Intermountain Heart Institute, Intermountain Medical Center, Salt Lake City UT.'}, {'ForeName': 'Heidi T', 'Initials': 'HT', 'LastName': 'May', 'Affiliation': 'Intermountain Heart Institute, Intermountain Medical Center, Salt Lake City UT.'}, {'ForeName': 'Kashif', 'Initials': 'K', 'LastName': 'Shaikh', 'Affiliation': 'Department of Medicine, Lundquist Institute at Harbor-UCLA Medical Center, Torrance CA.'}, {'ForeName': 'Chandana', 'Initials': 'C', 'LastName': 'Shekar', 'Affiliation': 'Department of Medicine, Lundquist Institute at Harbor-UCLA Medical Center, Torrance CA.'}, {'ForeName': 'April', 'Initials': 'A', 'LastName': 'Kinninger', 'Affiliation': 'Department of Medicine, Lundquist Institute at Harbor-UCLA Medical Center, Torrance CA.'}, {'ForeName': 'Suvasini', 'Initials': 'S', 'LastName': 'Lakshmanan', 'Affiliation': 'Department of Medicine, Lundquist Institute at Harbor-UCLA Medical Center, Torrance CA.'}, {'ForeName': 'Sion', 'Initials': 'S', 'LastName': 'Roy', 'Affiliation': 'Department of Medicine, Lundquist Institute at Harbor-UCLA Medical Center, Torrance CA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Tayek', 'Affiliation': 'Department of Medicine, Lundquist Institute at Harbor-UCLA Medical Center, Torrance CA.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Nelson', 'Affiliation': 'California Cardiovascular Institute, Fresno CA.'}]",Cardiovascular research,['10.1093/cvr/cvaa184'] 2386,32609361,"Effect of atorvastatin on muscle symptoms in coronary heart disease patients with self-perceived statin muscle side-effects: a randomized, double blinded crossover trial.","AIMS To estimate the effect of atorvastatin on muscle symptom intensity in coronary heart disease (CHD) patients with self-perceived statin-associated muscle symptoms (SAMS) and to determine the relationship to blood levels of atorvastatin and/or metabolites. METHODS AND RESULTS A randomized multi-center trial consecutively identified 982 patients with previous or ongoing atorvastatin treatment after a CHD event. Of these, 97 (9.9%) reported SAMS and 77 were randomized to 7-weeks double-blinded treatment with atorvastatin 40 mg/day and placebo in a crossover design. The primary outcome was the individual mean difference in muscle symptom intensity between the treatment periods, measured by visual-analogue scale (VAS) scores. Atorvastatin did not affect the intensity of muscle symptoms among 71 patients who completed the trial. Mean VAS difference [statin-placebo] was 0.31 (95% CI -0.24-0.86). The proportion with more muscle symptoms during placebo than atorvastatin was 17% (n = 12), 55% (n = 39) had the same muscle symptom intensity during both treatment periods whereas 28% (n = 20) had more symptoms during atorvastatin than placebo (confirmed SAMS). There were no differences in clinical or pharmacogenetic characteristics between these groups. The levels of atorvastatin and/or metabolites did not correlate to muscle symptom intensity among patients with confirmed SAMS (Spearmans rho ≤0.40, for all variables). CONCLUSION Re-challenge with high-intensity atorvastatin did not affect the intensity of muscle symptoms in CHD patients with self-perceived SAMS during previous atorvastatin therapy. There was no relationship between muscle symptoms and the systemic exposure to atorvastatin and/or its metabolites. The findings encourage an informed discussion to elucidate other causes of muscle complaints and continued statin use.",2020,"The levels of atorvastatin and/or metabolites did not correlate to muscle symptom intensity among patients with confirmed SAMS (Spearmans rho ≤0.40, for all variables). ","['coronary heart disease patients with self-perceived statin muscle side-effects', '71 patients who completed the trial', 'coronary heart disease (CHD) patients with self-perceived statin-associated muscle symptoms (SAMS', '982 patients with previous or ongoing atorvastatin treatment after a CHD event']","['atorvastatin', 'Atorvastatin', 'atorvastatin 40\u2009mg/day and placebo', 'placebo']","['muscle symptoms', 'proportion with more muscle symptoms', 'levels of atorvastatin and/or metabolites', 'visual-analogue scale (VAS) scores', 'intensity of muscle symptoms', 'Mean VAS difference', 'individual mean difference in muscle symptom intensity', 'muscle symptom intensity']","[{'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0286651', 'cui_str': 'atorvastatin'}, {'cui': 'C0001758', 'cui_str': 'Aftercare'}, {'cui': 'C0441471', 'cui_str': 'Event'}]","[{'cui': 'C0286651', 'cui_str': 'atorvastatin'}, {'cui': 'C1616508', 'cui_str': 'atorvastatin 40 MG [Lipitor]'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0286651', 'cui_str': 'atorvastatin'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0027361', 'cui_str': 'Person'}]",982.0,0.226306,"The levels of atorvastatin and/or metabolites did not correlate to muscle symptom intensity among patients with confirmed SAMS (Spearmans rho ≤0.40, for all variables). ","[{'ForeName': 'Oscar', 'Initials': 'O', 'LastName': 'Kristiansen', 'Affiliation': 'Department of Medicine, Drammen Hospital, Vestre Viken Hospital Trust, Dronninggata 28, Drammen, Norway.'}, {'ForeName': 'Nils Tore', 'Initials': 'NT', 'LastName': 'Vethe', 'Affiliation': 'Department of Pharmacology, Oslo University Hospital, Sognsvannsveien 20, Oslo, Norway.'}, {'ForeName': 'Kari', 'Initials': 'K', 'LastName': 'Peersen', 'Affiliation': 'Department of Cardiology, Vestfold Hospital Trust, Halfdan Wilhelmsens alle 17, Tønsberg, Norway.'}, {'ForeName': 'Morten Wang', 'Initials': 'MW', 'LastName': 'Fagerland', 'Affiliation': 'Oslo Centre for Biostatistics and Epidemiology, Research Support Services, Oslo University Hospital, Domus Medica, Gaustad, Sognsvannsveien 9, Oslo, Norway.'}, {'ForeName': 'Elise', 'Initials': 'E', 'LastName': 'Sverre', 'Affiliation': 'Department of Medicine, Drammen Hospital, Vestre Viken Hospital Trust, Dronninggata 28, Drammen, Norway.'}, {'ForeName': 'Elena Prunés', 'Initials': 'EP', 'LastName': 'Jensen', 'Affiliation': 'Department of Laboratory Medicine, Vestre Viken Hospital Trust, Dronninggata 28, Drammen, Norway.'}, {'ForeName': 'Morten', 'Initials': 'M', 'LastName': 'Lindberg', 'Affiliation': 'Central Laboratory, Vestfold Hospital Trust, Halfdan Wilhelmsens alle 17, Tønsberg, Norway.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Gjertsen', 'Affiliation': 'Department of Medicine, Drammen Hospital, Vestre Viken Hospital Trust, Dronninggata 28, Drammen, Norway.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Gullestad', 'Affiliation': 'Department of Cardiology, Oslo University Hospital Rikshospitalet, and Institute of Clinical Medicine, University of Oslo, Sognsvannsveien 20, Oslo, Norway.'}, {'ForeName': 'Joep', 'Initials': 'J', 'LastName': 'Perk', 'Affiliation': 'Department of Cardiology, Public Health Department, Linnaeus University, Kalmar, Sweden.'}, {'ForeName': 'Toril', 'Initials': 'T', 'LastName': 'Dammen', 'Affiliation': 'Department of Behavioural Sciences in Medicine, Faculty of Medicine, University of Oslo, Domus Medica, Sognsvannsveien 9, Oslo, Norway.'}, {'ForeName': 'Stein', 'Initials': 'S', 'LastName': 'Bergan', 'Affiliation': 'Department of Pharmacology, Oslo University Hospital, Sognsvannsveien 20, Oslo, Norway.'}, {'ForeName': 'Einar', 'Initials': 'E', 'LastName': 'Husebye', 'Affiliation': 'Department of Medicine, Drammen Hospital, Vestre Viken Hospital Trust, Dronninggata 28, Drammen, Norway.'}, {'ForeName': 'Jan Erik', 'Initials': 'JE', 'LastName': 'Otterstad', 'Affiliation': 'Department of Cardiology, Vestfold Hospital Trust, Halfdan Wilhelmsens alle 17, Tønsberg, Norway.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Munkhaugen', 'Affiliation': 'Department of Medicine, Drammen Hospital, Vestre Viken Hospital Trust, Dronninggata 28, Drammen, Norway.'}]",European heart journal. Cardiovascular pharmacotherapy,['10.1093/ehjcvp/pvaa076'] 2387,32609412,"Multifactorial Intervention on Type 2 Diabetes (MIDiab) Study: A Multicenter, Open-Label, Randomized, Parallel Controlled, Community Trial.",,2020,,[],['Multifactorial Intervention'],[],[],"[{'cui': 'C0184661', 'cui_str': 'Procedure'}]",[],,0.0248914,,"[{'ForeName': 'Yupeng', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Department of Endocrinology, Shandong Provincial Hospital, Cheeloo College of Medicine, Shandong University, Jinan, Shandong, China.'}, {'ForeName': 'Qingbo', 'Initials': 'Q', 'LastName': 'Guan', 'Affiliation': 'Department of Endocrinology, Shandong Provincial Hospital, Cheeloo College of Medicine, Shandong University, Jinan, Shandong, China.'}, {'ForeName': 'Xu', 'Initials': 'X', 'LastName': 'Hou', 'Affiliation': 'Department of Endocrinology, Shandong Provincial Hospital, Cheeloo College of Medicine, Shandong University, Jinan, Shandong, China.'}, {'ForeName': 'Xu', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Department of Endocrinology, Shandong Provincial Hospital, Cheeloo College of Medicine, Shandong University, Jinan, Shandong, China.'}, {'ForeName': 'Haiqing', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Department of Endocrinology, Shandong Provincial Hospital, Cheeloo College of Medicine, Shandong University, Jinan, Shandong, China.'}, {'ForeName': 'Chao', 'Initials': 'C', 'LastName': 'Xu', 'Affiliation': 'Department of Endocrinology, Shandong Provincial Hospital, Cheeloo College of Medicine, Shandong University, Jinan, Shandong, China.'}, {'ForeName': 'Fei', 'Initials': 'F', 'LastName': 'Jing', 'Affiliation': 'Department of Endocrinology, Shandong Provincial Hospital, Cheeloo College of Medicine, Shandong University, Jinan, Shandong, China.'}, {'ForeName': 'Shizhan', 'Initials': 'S', 'LastName': 'Ma', 'Affiliation': 'Department of Endocrinology, Shandong Provincial Hospital, Cheeloo College of Medicine, Shandong University, Jinan, Shandong, China.'}, {'ForeName': 'Shanshan', 'Initials': 'S', 'LastName': 'Shao', 'Affiliation': 'Department of Endocrinology, Shandong Provincial Hospital, Cheeloo College of Medicine, Shandong University, Jinan, Shandong, China.'}, {'ForeName': 'Meng', 'Initials': 'M', 'LastName': 'Zhao', 'Affiliation': 'Department of Endocrinology, Shandong Provincial Hospital, Cheeloo College of Medicine, Shandong University, Jinan, Shandong, China.'}, {'ForeName': 'Qingling', 'Initials': 'Q', 'LastName': 'Guo', 'Affiliation': 'Department of Endocrinology, Shandong Provincial Hospital, Cheeloo College of Medicine, Shandong University, Jinan, Shandong, China.'}, {'ForeName': 'Fang', 'Initials': 'F', 'LastName': 'Zhong', 'Affiliation': 'Department of Endocrinology, Shandong Provincial Hospital, Cheeloo College of Medicine, Shandong University, Jinan, Shandong, China.'}, {'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Gao', 'Affiliation': 'Shandong Provincial Key Laboratory of Endocrinology and Lipid Metabolism, Institute of Endocrinology and metabolism, Shandong Academy of Clinical Medicine, Jinan, Shandong, China.'}, {'ForeName': 'Jiajun', 'Initials': 'J', 'LastName': 'Zhao', 'Affiliation': 'Department of Endocrinology, Shandong Provincial Hospital, Cheeloo College of Medicine, Shandong University, Jinan, Shandong, China.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Journal of diabetes,['10.1111/1753-0407.13081'] 2388,32603172,Experimental Implementation of Universal Nonadiabatic Geometric Quantum Gates in a Superconducting Circuit.,"Using geometric phases to realize noise-resilient quantum computing is an important method to enhance the control fidelity. In this work, we experimentally realize a universal nonadiabatic geometric quantum gate set in a superconducting qubit chain. We characterize the realized single- and two-qubit geometric gates with both quantum process tomography and randomized benchmarking methods. The measured average fidelities for the single-qubit rotation gates and two-qubit controlled-Z gate are 0.9977(1) and 0.977(9), respectively. Besides, we also experimentally demonstrate the noise-resilient feature of the realized single-qubit geometric gates by comparing their performance with the conventional dynamical gates with different types of errors in the control field. Thus, our experiment proves a way to achieve high-fidelity geometric quantum gates for robust quantum computation.",2020,"The measured average fidelities for the single-qubit rotation gates and two-qubit controlled-Z gate are 0.9977(1) and 0.977(9), respectively.",[],['Universal Nonadiabatic Geometric Quantum Gates'],[],[],"[{'cui': 'C0175671', 'cui_str': 'Universal'}, {'cui': 'C0237633', 'cui_str': 'Sensory Filtering'}]",[],,0.0283354,"The measured average fidelities for the single-qubit rotation gates and two-qubit controlled-Z gate are 0.9977(1) and 0.977(9), respectively.","[{'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Xu', 'Affiliation': 'Center for Quantum Information, Institute for Interdisciplinary Information Sciences, Tsinghua University, Beijing 100084, China.'}, {'ForeName': 'Z', 'Initials': 'Z', 'LastName': 'Hua', 'Affiliation': 'Center for Quantum Information, Institute for Interdisciplinary Information Sciences, Tsinghua University, Beijing 100084, China.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Chen', 'Affiliation': 'Guangdong Provincial Key Laboratory of Quantum Engineering and Quantum Materials, GPETR Center for Quantum Precision Measurement, and School of Physics and Telecommunication Engineering, South China Normal University, Guangzhou 510006, China.'}, {'ForeName': 'X', 'Initials': 'X', 'LastName': 'Pan', 'Affiliation': 'Center for Quantum Information, Institute for Interdisciplinary Information Sciences, Tsinghua University, Beijing 100084, China.'}, {'ForeName': 'X', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Center for Quantum Information, Institute for Interdisciplinary Information Sciences, Tsinghua University, Beijing 100084, China.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Han', 'Affiliation': 'Center for Quantum Information, Institute for Interdisciplinary Information Sciences, Tsinghua University, Beijing 100084, China.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Cai', 'Affiliation': 'Center for Quantum Information, Institute for Interdisciplinary Information Sciences, Tsinghua University, Beijing 100084, China.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Ma', 'Affiliation': 'Center for Quantum Information, Institute for Interdisciplinary Information Sciences, Tsinghua University, Beijing 100084, China.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Center for Quantum Information, Institute for Interdisciplinary Information Sciences, Tsinghua University, Beijing 100084, China.'}, {'ForeName': 'Y P', 'Initials': 'YP', 'LastName': 'Song', 'Affiliation': 'Center for Quantum Information, Institute for Interdisciplinary Information Sciences, Tsinghua University, Beijing 100084, China.'}, {'ForeName': 'Zheng-Yuan', 'Initials': 'ZY', 'LastName': 'Xue', 'Affiliation': 'Guangdong Provincial Key Laboratory of Quantum Engineering and Quantum Materials, GPETR Center for Quantum Precision Measurement, and School of Physics and Telecommunication Engineering, South China Normal University, Guangzhou 510006, China.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Sun', 'Affiliation': 'Center for Quantum Information, Institute for Interdisciplinary Information Sciences, Tsinghua University, Beijing 100084, China.'}]",Physical review letters,['10.1103/PhysRevLett.124.230503'] 2389,32603238,"SPORTS STARS: a practitioner-led, peer-group sports intervention for ambulant children with cerebral palsy. Activity and participation outcomes of a randomised controlled trial.","Purpose: To investigate the effectiveness of a practitioner-led, peer-group sports intervention for children with CP at GMFCS Level I-II. Method: Children with CP (GMFCS I-II; 6-12 years) were randomised to Sports Stars or waitlist-control groups. Sports Stars included eight-weeks (eight hours) of physiotherapist-led, sports-specific gross motor activity training, sports education, teamwork development and confidence building. Sports participation was measured using self-identified participation goals (modified Canadian Occupational Performance Measure (mCOPM)). Physical competence was measured with mCOPM activity goals and high-level gross motor batteries (Test of Gross Motor Development (TGMD-2); GMFM-Challenge) and walking (Timed-Up-and-Go), running (Muscle Power Sprint Test; 10x5m Sprint Test), jumping (Standing Broad Jump; Vertical Jump) and throwing (Seated Throw) items. General participation and quality of life were also measured. Outcomes were measured pre, post and 12-weeks post-intervention. Data were analysed using linear mixed models. Results: Fifty-four children were randomised into Sports Stars ( n  = 29; GMFCS I  = 7, II = 22; male = 19; 8.9 ± 2 years) or waitlist-control groups ( n  = 25; GMFCS I  = 10, II = 15; male = 14; 8.6 ± 2 years). The Sports Stars group improved sports participation and activity goals (mCOPM F  = 5.49-10.29, p  < 0.001) and sports-specific physical competence (TGMD-2, F  = 3.45-5.19, p  = 0.001-0.009) compared to the waitlist-control. Conclusion: Sports Stars is effective for improving sports-specific participation and physical competence for children with CP.Implications for rehabilitation Sports Stars improves performance and satisfaction in sports-specific participation and activity goals for ambulant children with CP. Sports Stars improves sports-specific physical activity competence in locomotor and object control skills.Sport-specific interventions should incorporate sport-specific gross motor activity training as well as sports education, confidence building and teamwork.",2020,"mCOPM F  = 5.49-10.29, p  < 0.001) and sports-specific physical competence (TGMD-2, F  = 3.45-5.19, ","['Method: Children with CP (GMFCS I-II; 6-12\u2009years', 'ambulant children with cerebral palsy', 'Results: Fifty-four children were randomised into Sports Stars ( n \u2009=\u200929; GMFCS I \u2009=\u20097, II = 22; male = 19; 8.9\u2009±\u20092\u2009years) or waitlist-control groups ( n \u2009=\u200925; GMFCS I \u2009=\u200910, II = 15; male = 14; 8.6\u2009±\u20092\u2009years', 'ambulant children with CP', 'children with CP at GMFCS Level I-II']","['Sports Stars or waitlist-control groups', 'practitioner-led, peer-group sports intervention']","['sports-specific physical competence', 'sports participation and activity goals ', 'mCOPM activity goals and high-level gross motor batteries (Test of Gross Motor Development (TGMD-2); GMFM-Challenge) and walking (Timed-Up-and-Go), running (Muscle Power Sprint Test; 10x5m Sprint Test), jumping (Standing Broad Jump; Vertical Jump) and throwing (Seated Throw) items', 'sports-specific physical activity competence', 'General participation and quality of life', 'self-identified participation goals (modified Canadian Occupational Performance Measure (mCOPM', 'Physical competence']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0007789', 'cui_str': 'Cerebral palsy'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C4517807', 'cui_str': '54'}, {'cui': 'C0038039', 'cui_str': 'Sport'}, {'cui': 'C0282064', 'cui_str': 'Stars, Celestial'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4517879', 'cui_str': '8.6'}, {'cui': 'C0441925', 'cui_str': 'Level I'}]","[{'cui': 'C0038039', 'cui_str': 'Sport'}, {'cui': 'C0282064', 'cui_str': 'Stars, Celestial'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0030767', 'cui_str': 'Peer Group'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0038039', 'cui_str': 'Sport'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0086035', 'cui_str': 'Competence'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0439806', 'cui_str': 'Gross'}, {'cui': 'C0337088', 'cui_str': 'Electrical battery'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0427052', 'cui_str': 'Finding of power of skeletal muscle'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0332464', 'cui_str': 'Widening'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0277814', 'cui_str': 'Sitting position'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C2585956', 'cui_str': 'Canadian occupational performance measure'}]",54.0,0.0197948,"mCOPM F  = 5.49-10.29, p  < 0.001) and sports-specific physical competence (TGMD-2, F  = 3.45-5.19, ","[{'ForeName': 'Georgina L', 'Initials': 'GL', 'LastName': 'Clutterbuck', 'Affiliation': 'School of Health & Rehabilitation Sciences, The University of Queensland, St Lucia, Australia.'}, {'ForeName': 'Megan L', 'Initials': 'ML', 'LastName': 'Auld', 'Affiliation': 'CPL - Choice, Passion, Life (previously the Cerebral Palsy League), Brisbane, Australia.'}, {'ForeName': 'Leanne M', 'Initials': 'LM', 'LastName': 'Johnston', 'Affiliation': 'School of Health & Rehabilitation Sciences, The University of Queensland, St Lucia, Australia.'}]",Disability and rehabilitation,['10.1080/09638288.2020.1783376'] 2390,32603389,CO2 laser ablative fractional resurfacing photodynamic therapy for actinic keratosis and nonmelanoma skin cancer: a randomized split-side study.,"Aminolevulinic acid (ALA) photodynamic therapy (PDT) is a preferred method for treatment of multiple actinic keratoses (AKs) in broad skin areas (referred to as field cancerization). Pretreatment with CO2 laser ablative fractional resurfacing (AFR) may increase the efficacy of PDT. This study compared the effect and durability of CO2 laser AFR-assisted ALA-PDT vs ALA-PDT alone in the treatment of AKs and nonmelanoma skin cancers (NMSCs) at various body locations. In this randomized, split-side study, 19 patients had 1 side pretreated with AFR before treatment of both sides with ALA-PDT. Results indicated that pretreatment with AFR provided superior clearance of AKs and thin NMSCs at 6 months compared to ALA-PDT alone.",2020,Results indicated that pretreatment with AFR provided superior clearance of AKs and thin NMSCs at 6 months compared to ALA-PDT alone.,"['19 patients had 1 side pretreated with AFR before treatment of both sides with ALA-PDT', 'actinic keratosis and nonmelanoma skin cancer', 'AKs and nonmelanoma skin cancers (NMSCs) at various body locations']","['CO2 laser AFR-assisted ALA-PDT vs ALA-PDT alone', 'Aminolevulinic acid (ALA) photodynamic therapy (PDT', 'CO2 laser ablative fractional resurfacing photodynamic therapy', 'CO2 laser ablative fractional resurfacing (AFR']",[],"[{'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0002563', 'cui_str': 'Aminolevulinic Acid'}, {'cui': 'C0031740', 'cui_str': 'Photochemotherapy'}, {'cui': 'C0022602', 'cui_str': 'Actinic keratosis'}, {'cui': 'C0699893', 'cui_str': 'Skin carcinoma'}, {'cui': 'C0439681', 'cui_str': 'Actinic'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0450429', 'cui_str': 'Location'}]","[{'cui': 'C0392251', 'cui_str': 'Carbon dioxide laser device'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0002563', 'cui_str': 'Aminolevulinic Acid'}, {'cui': 'C0031740', 'cui_str': 'Photochemotherapy'}]",[],19.0,0.0169007,Results indicated that pretreatment with AFR provided superior clearance of AKs and thin NMSCs at 6 months compared to ALA-PDT alone.,"[{'ForeName': 'Martin B', 'Initials': 'MB', 'LastName': 'Miller', 'Affiliation': 'University of California, San Francisco, USA.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Padilla', 'Affiliation': 'Maxim Healthcare Services, Sacramento, California, USA.'}]",Cutis,[] 2391,32603408,A Randomized Comparison Study of Lyophilized Nile Tilapia Skin and Silver-Impregnated Sodium Carboxymethylcellulose for the Treatment of Superficial Partial-Thickness Burns.,"BACKGROUND Glycerolized Nile tilapia skin showed promising results when used for burn treatment in phase II and phase III randomized controlled trials. This pilot study aims to evaluate the effectiveness of lyophilized Nile tilapia skin as a temporary skin substitute for superficial partial-thickness burns by comparing it to silver-impregnated sodium carboxymethylcellulose dressing. METHODS This was a randomized, prospective, open-label, controlled pilot study conducted in Fortaleza, Brazil, from April 2019 to December 2019. The 24 participants had ≥18 and ≤70 years of age and superficial partial-thickness burns affecting up to 10% of total body surface area. Primary outcomes were the number of dressings performed and pain intensity, assessed via the Visual Analogue Scale and the Electronic von Frey. Secondary outcomes were the level of pain-related anxiety, assessed via the Burns Specific Pain Anxiety Scale, and analgesic consumption. RESULTS In the test group, the number of dressings and the patient-reported pain after dressing-related procedures were lower. Analgesic intake, pain-related anxiety, and both patient-reported and objectively measured pain before dressing-related procedures were similar for the treatment groups. No side effects were detected. CONCLUSION Lyophilized Nile tilapia skin shares the same characteristics of an ''ideal'' wound dressing demonstrated by glycerolized Nile tilapia skin in previous studies. Also, it demonstrated non-inferiority for burn management when compared to silver-impregnated sodium carboxymethylcellulose dressing. The safety and efficacy of lyophilized Nile tilapia skin demonstrated in this pilot study may allow the development of larger phase II and phase III RCTs in a near future.",2020,"In the test group, the number of dressings and the patient-reported pain after dressing-related procedures were lower.","['24 participants had ≥18 and ≤70 years of age and superficial partial-thickness burns affecting up to 10% of total body surface area', 'superficial partial-thickness burns', 'Superficial Partial-Thickness Burns', 'Fortaleza, Brazil, from April 2019 to December 2019']","['lyophilized Nile tilapia skin', 'Lyophilized Nile Tilapia Skin and Silver-Impregnated Sodium Carboxymethylcellulose', 'silver-impregnated sodium carboxymethylcellulose dressing']","['number of dressings and the patient-reported pain', 'level of pain-related anxiety, assessed via the Burns Specific Pain Anxiety Scale, and analgesic consumption', 'Analgesic intake, pain-related anxiety', 'number of dressings performed and pain intensity, assessed via the Visual Analogue Scale and the Electronic von Frey', 'side effects']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0433365', 'cui_str': 'Superficial partial thickness burn'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C0445175', 'cui_str': 'Percent of body surface'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]","[{'cui': 'C0162641', 'cui_str': 'Tilapia nilotica'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0037125', 'cui_str': 'silver'}, {'cui': 'C0037487', 'cui_str': 'Carboxymethylcellulose sodium'}, {'cui': 'C0013119', 'cui_str': 'Medical dressing'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0013119', 'cui_str': 'Medical dressing'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0000912', 'cui_str': 'Accident caused by unspecified fire'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0162473', 'cui_str': 'Auriculotemporal syndrome'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",,0.0297238,"In the test group, the number of dressings and the patient-reported pain after dressing-related procedures were lower.","[{'ForeName': 'Edmar Maciel', 'Initials': 'EM', 'LastName': 'Lima Júnior', 'Affiliation': 'Burn Treatment Center, Dr. José Frota Institute, Fortaleza, CE, Brazil.'}, {'ForeName': 'Manoel Odorico', 'Initials': 'MO', 'LastName': 'de Moraes Filho', 'Affiliation': 'Clinical Pharmacology Unit, Drug Research and Development Center, Federal University of Ceará (UFC), Fortaleza, CE, Brazil.'}, {'ForeName': 'Bruno Almeida', 'Initials': 'BA', 'LastName': 'Costa', 'Affiliation': 'Clinical Pharmacology Unit, Drug Research and Development Center, Federal University of Ceará (UFC), Fortaleza, CE, Brazil.'}, {'ForeName': 'Francisco Vagnaldo', 'Initials': 'FV', 'LastName': 'Fechine', 'Affiliation': 'Clinical Pharmacology Unit, Drug Research and Development Center, Federal University of Ceará (UFC), Fortaleza, CE, Brazil.'}, {'ForeName': 'Marina Becker Sales', 'Initials': 'MBS', 'LastName': 'Rocha', 'Affiliation': 'Clinical Pharmacology Unit, Drug Research and Development Center, Federal University of Ceará (UFC), Fortaleza, CE, Brazil.'}, {'ForeName': 'Mariana Lima', 'Initials': 'ML', 'LastName': 'Vale', 'Affiliation': 'Clinical Pharmacology Unit, Drug Research and Development Center, Federal University of Ceará (UFC), Fortaleza, CE, Brazil.'}, {'ForeName': 'Ana Kely de Loyola', 'Initials': 'AKL', 'LastName': 'Diógenes', 'Affiliation': 'Graduate Program in Morphofunctional Sciences, School of Medicine, Federal University of Ceará (UFC), Fortaleza, CE, Brazil.'}, {'ForeName': 'Alex Marques do Nascimento', 'Initials': 'AMDN', 'LastName': 'Uchôa', 'Affiliation': 'Burn Treatment Center, Dr. José Frota Institute, Fortaleza, CE, Brazil.'}, {'ForeName': 'Francisco Raimundo', 'Initials': 'FR', 'LastName': 'Silva Júnior', 'Affiliation': 'Burn Treatment Center, Dr. José Frota Institute, Fortaleza, CE, Brazil.'}, {'ForeName': 'Camila Barroso', 'Initials': 'CB', 'LastName': 'Martins', 'Affiliation': 'Clinical Pharmacology Unit, Drug Research and Development Center, Federal University of Ceará (UFC), Fortaleza, CE, Brazil.'}, {'ForeName': 'Tereza de Jesus Pinheiro Gomes', 'Initials': 'TJPG', 'LastName': 'Bandeira', 'Affiliation': 'School of Medicine, Christus University Center (UNICHRISTUS), Fortaleza, CE, Brazil.'}, {'ForeName': 'Felipe Augusto', 'Initials': 'FA', 'LastName': 'Rocha Rodrigues', 'Affiliation': 'Clinical Pharmacology Unit, Drug Research and Development Center, Federal University of Ceará (UFC), Fortaleza, CE, Brazil.'}, {'ForeName': 'Carlos Roberto Koscky', 'Initials': 'CRK', 'LastName': 'Paier', 'Affiliation': 'Clinical Pharmacology Unit, Drug Research and Development Center, Federal University of Ceará (UFC), Fortaleza, CE, Brazil.'}, {'ForeName': 'Maria Elisabete Amaral', 'Initials': 'MEA', 'LastName': 'de Moraes', 'Affiliation': 'Clinical Pharmacology Unit, Drug Research and Development Center, Federal University of Ceará (UFC), Fortaleza, CE, Brazil.'}]",Journal of burn care & research : official publication of the American Burn Association,['10.1093/jbcr/iraa099'] 2392,32603494,Similar safety and efficacy in previously treated adults with growth hormone deficiency randomised to once-weekly somapacitan or daily growth hormone.,"OBJECTIVE Somapacitan is a long-acting, reversible albumin-binding growth hormone (GH) derivative in development. This study aimed to evaluate the safety and efficacy of once-weekly somapacitan versus daily GH over 52 weeks in Japanese patients with adult growth hormone deficiency (AGHD). DESIGN Phase 3, multicentre, randomised, parallel-group, open-label, active-controlled trial (NCT03075644). Patients Previously GH-treated Japanese patients with AGHD were randomised 3:1 to somapacitan (n = 46) or daily GH (n = 16) for 20 weeks' dose titration and 32 weeks' fixed-dose treatment. Measurements Primary endpoint was the incidence of adverse events (AEs). Secondary endpoints included change from baseline to week 52 in visceral, subcutaneous and total adipose tissue (VAT, SAT and TAT). RESULTS Mean (SD) prescribed doses after titration were 1.780 (1.058) mg/week for somapacitan and 0.197 (0.083) mg/day for daily GH. Rate of AEs per 100 patient-years was similar between arms (somapacitan, 312.7; daily GH, 309.8). Four AEs in the somapacitan arm were serious; none were considered treatment-related. Mean insulin-like growth factor-I standard deviation score (IGF-I SDS) was maintained from baseline in both arms. No significant differences were observed between arms for change from baseline to week 52 in VAT, SAT or TAT (estimated difference, somapacitan - daily GH [95% CI]: -1.74 [-18.13; 14.66], -11.53 [-35.54; 12.48] and -12.85 [-47.31; 21.62] cm 2 , respectively). CONCLUSIONS Treatment in both groups was well tolerated, with no unexpected safety findings. Impact on adipose tissue was similar with somapacitan and daily GH in patients with AGHD. A short visual summary of our work is available (1). (Otsuka et al. Animated summary. URL TBC).",2020,"No significant differences were observed between arms for change from baseline to week 52 in VAT, SAT or TAT (estimated difference, somapacitan - daily GH [95% CI]:","['Patients Previously GH-treated Japanese patients with AGHD', 'Japanese patients with adult growth hormone deficiency (AGHD', 'previously treated adults with growth hormone deficiency', 'patients with AGHD', '21.62']","['once-weekly somapacitan versus daily GH', 'somapacitan or daily growth hormone', 'daily GH', 'somapacitan']","['I standard deviation score (IGF-I SDS', 'VAT, SAT or TAT', 'adipose tissue', 'change from baseline to week\xa052 in visceral, subcutaneous and total adipose tissue (VAT, SAT and TAT', 'safety and efficacy', 'incidence of adverse events (AEs', 'Mean insulin-like growth factor']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0037663', 'cui_str': 'Somatotropin'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C1720505', 'cui_str': 'Adult growth hormone deficiency'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0271561', 'cui_str': 'Growth hormone deficiency'}]","[{'cui': 'C0558293', 'cui_str': 'Once a week'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0037663', 'cui_str': 'Somatotropin'}]","[{'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0021665', 'cui_str': 'Somatomedin C'}, {'cui': 'C0042427', 'cui_str': 'Vatican City'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0017375', 'cui_str': 'TAT gene'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0442045', 'cui_str': 'Visceral'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0037657', 'cui_str': 'Somatomedin'}]",,0.297851,"No significant differences were observed between arms for change from baseline to week 52 in VAT, SAT or TAT (estimated difference, somapacitan - daily GH [95% CI]:","[{'ForeName': 'Fumio', 'Initials': 'F', 'LastName': 'Otsuka', 'Affiliation': 'Department of General Medicine, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama, Japan.'}, {'ForeName': 'Yutaka', 'Initials': 'Y', 'LastName': 'Takahashi', 'Affiliation': 'Division of Diabetes and Endocrinology, Department of Internal Medicine, Kobe University Graduate School of Medicine, Kobe, Japan.'}, {'ForeName': 'Shigeyuki', 'Initials': 'S', 'LastName': 'Tahara', 'Affiliation': 'Department of Neurosurgery, Nippon Medical School, Tokyo, Japan.'}, {'ForeName': 'Yoshihisa', 'Initials': 'Y', 'LastName': 'Ogawa', 'Affiliation': 'CMR Development Division, Novo Nordisk Pharma Ltd, Tokyo, Japan.'}, {'ForeName': 'Michael Højby', 'Initials': 'MH', 'LastName': 'Rasmussen', 'Affiliation': 'Global Development, Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Koji', 'Initials': 'K', 'LastName': 'Takano', 'Affiliation': 'Department of Endocrinology, Diabetes and Metabolism, Kitasato University, Sagamihara, Japan.'}]",Clinical endocrinology,['10.1111/cen.14273'] 2393,32603526,Oral Hypoxia-Inducible Factor Prolyl Hydroxylase Inhibitor Roxadustat (FG-4592) for Treatment of Anemia in Chronic Kidney Disease: A Placebo-Controlled Study of Pharmacokinetic and Pharmacodynamic Profiles in Hemodialysis Patients.,"Roxadustat (FG-4592), an oral hypoxia-inducible factor prolyl hydroxylase inhibitor that stimulates erythropoiesis, was evaluated in a phase 1b study in patients with end-stage renal disease with anemia on hemodialysis. Seventeen patients, on epoetin-alfa maintenance therapy with stable hemoglobin levels ≥10 g/dL, had epoetin-alfa discontinued on day 3 and were enrolled in this double-blind placebo-controlled study. Two cohorts were randomized 3:1 (roxadustat: placebo). Patients received single doses of roxadustat (1 or 2 mg/kg) or placebo 1 hour after hemodialysis on day 1 and 2 hours before dialysis on day 8. Maximum plasma concentration and area under the plasma concentration-time curve for patients receiving roxadustat were slightly more than dose proportional and elimination half-life ranged from 14.7 to 19.4 hours. Roxadustat was highly protein bound (99%) in plasma, and dialysis contributed a small fraction of the total clearance: only 4.56% and 3.04% of roxadustat recovered from the 1 and 2 mg/kg dose groups, respectively. Roxadustat induced transient elevations of endogenous erythropoietin that peaked between 7 and 14 hours after dosing and returned to baseline by 48 hours after dosing. Peak median endogenous erythropoietin levels were 96 mIU/mL and 268 mIU/mL for the 1- and 2-mg/kg doses, respectively, within physiologic range of endogenous erythropoietin responses to hypoxia at high altitude or after blood loss. No serious adverse events were reported, and there were no treatment- or dose-related trends in adverse event incidence.",2020,"No serious adverse events were reported, and there were no treatment- or dose-related trends in adverse event incidence.","['Chronic Kidney Disease', 'Hemodialysis Patients', 'patients with end-stage renal disease with anemia on hemodialysis', 'Seventeen patients, on epoetin-alfa maintenance therapy with stable hemoglobin levels ≥10\xa0g/dL, had epoetin-alfa discontinued on day 3 and were enrolled in this double-blind']","['Roxadustat (FG-4592), an oral hypoxia-inducible factor prolyl hydroxylase inhibitor', 'Oral Hypoxia-Inducible Factor Prolyl Hydroxylase Inhibitor Roxadustat (FG-4592', 'Placebo', 'placebo']","['Peak median endogenous erythropoietin levels', 'serious adverse events', 'transient elevations of endogenous erythropoietin', 'Maximum plasma concentration and area under the plasma concentration-time curve']","[{'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022661', 'cui_str': 'Chronic renal failure'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0450331', 'cui_str': '17'}, {'cui': 'C0357126', 'cui_str': 'Epoetin Alfa'}, {'cui': 'C0677908', 'cui_str': 'Maintenance therapy'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0518015', 'cui_str': 'Haemoglobin'}, {'cui': 'C0439267', 'cui_str': 'g/dL'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0013072', 'cui_str': 'Double-Blind Study'}]","[{'cui': 'C3713379', 'cui_str': 'FG-4592'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C3658210', 'cui_str': 'Proline Hydroxylase Inhibitors'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0205227', 'cui_str': 'Endogenous'}, {'cui': 'C0202001', 'cui_str': 'Erythropoietin measurement'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0040704', 'cui_str': 'Transients'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0014822', 'cui_str': 'erythropoietin'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205134', 'cui_str': 'Curved'}]",2.0,0.0875764,"No serious adverse events were reported, and there were no treatment- or dose-related trends in adverse event incidence.","[{'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Provenzano', 'Affiliation': 'Department of Medicine, Wayne State University, Detroit, Michigan, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Tumlin', 'Affiliation': 'Southeast Renal Research Institute, Chattanooga, Tennessee, USA.'}, {'ForeName': 'Raja', 'Initials': 'R', 'LastName': 'Zabaneh', 'Affiliation': 'Northwest Louisiana Nephrology Research, Shreveport, Louisiana, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Chou', 'Affiliation': 'FibroGen, Inc., San Francisco, California, USA.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Hemmerich', 'Affiliation': 'FibroGen, Inc., San Francisco, California, USA.'}, {'ForeName': 'Thomas B', 'Initials': 'TB', 'LastName': 'Neff', 'Affiliation': 'FibroGen, Inc., San Francisco, California, USA.'}, {'ForeName': 'K-H Peony', 'Initials': 'KP', 'LastName': 'Yu', 'Affiliation': 'FibroGen, Inc., San Francisco, California, USA.'}]",Journal of clinical pharmacology,['10.1002/jcph.1648'] 2394,32603531,Febuxostat therapy in outpatients with suspected COVID-19: A clinical trial.,"BACKGROUND The aim of this clinical trial was to evaluate the effects of febuxostat (FBX) in comparison with hydroxychloroquine (HCQ) on clinical symptoms, laboratory tests and chest CT findings in outpatients with moderate symptoms of COVID-19 infection. METHODS We conducted a clinical trial involving adult outpatients with the moderate respiratory illness following COVID-19 infection. Patients were randomly assigned to receive either FBX or HCQ for 5 days. The measured variables were needs to hospitalization, clinical and laboratory data including fever, cough, breathing rate, C-Reactive Protein level, lymphocytes count at onset of admission and was well as at 5 days of treatments. In addition, CT findings were evaluated on admission and 14 days after initiation of treatment. RESULTS Sixty subjects were enrolled in the study with a 1 to 1 ratio in FBX and HCQ groups. On admission, fever (66.7%), cough (87%), tachypnea (44.4%), dyspnea (35%), elevated CRP value (94.4%) and lung involvement according to chest CT (100%) were documented in enrolled patients with insignificant difference between FBX and HCQ groups. Fever, cough and tachypnea were significantly mitigated in both groups after five days of treatments without any significant differences between groups. The mean percentages of lung involvement were significantly reduced to 7.3% and 8% after 14 days of treatment with FBX and HCQ, respectively. In adult outpatients with moderate COVID-19 infection, the effectiveness of FBX and HCQ was not different in terms of resolution of clinical manifestations, laboratory tests and lung CT findings. CONCLUSION This trial suggests that FBX is as an alternative treatment to HCQ for COVID-19 infection and may be considered in patients with a contraindication or precaution to HCQ.",2020,"Fever, cough and tachypnea were significantly mitigated in both groups after five days of treatments without any significant differences between groups.","['Sixty subjects were enrolled in the study with a 1 to 1 ratio in FBX and HCQ groups', 'outpatients with suspected COVID-19', 'patients with a contraindication or precaution to HCQ', 'adult outpatients with the moderate respiratory illness following COVID-19 infection', 'adult outpatients with moderate COVID-19 infection', 'outpatients with moderate symptoms of COVID-19 infection']","['Febuxostat therapy', 'FBX', 'hydroxychloroquine (HCQ', 'FBX or HCQ', 'febuxostat (FBX']","['hospitalization, clinical and laboratory data including fever, cough, breathing rate, C-Reactive Protein level, lymphocytes count at onset of admission', 'mean percentages of lung involvement', 'cough', 'Fever, cough and tachypnea', 'dyspnea', 'tachypnea', 'elevated CRP value']","[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0249529', 'cui_str': 'febuxostat'}, {'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0522473', 'cui_str': 'Contraindication to'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]","[{'cui': 'C0249529', 'cui_str': 'febuxostat'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}]","[{'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0015967', 'cui_str': 'Fever'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0231832', 'cui_str': 'Respiratory rate'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0332162', 'cui_str': 'Onset of'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0231835', 'cui_str': 'Tachypnea'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0742906', 'cui_str': 'Elevated C-reactive protein'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",60.0,0.0984218,"Fever, cough and tachypnea were significantly mitigated in both groups after five days of treatments without any significant differences between groups.","[{'ForeName': 'Lotfollah', 'Initials': 'L', 'LastName': 'Davoodi', 'Affiliation': 'Department of Infection Diseases, Antimicrobial Resistance Research Center, Faculty of Medicine, Mazandaran University of Medical Sciences, Sari, Iran.'}, {'ForeName': 'Seyed Mohammad', 'Initials': 'SM', 'LastName': 'Abedi', 'Affiliation': 'Department of Radiology, Faculty of Medicine, Mazandaran University of Medical Sciences, Sari, Iran.'}, {'ForeName': 'Ebrahim', 'Initials': 'E', 'LastName': 'Salehifar', 'Affiliation': 'Department of Clinical Pharmacy, Pharmaceutical Sciences Research Center, Hemoglobinopathy Institute, Faculty of Pharmacy, Mazandaran University of Medical Sciences, Sari, Iran.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Alizadeh-Navai', 'Affiliation': 'Gastrointestinal Cancer Research Center, Mazandaran University of Medical Sciences, Sari, Iran.'}, {'ForeName': 'Hamed', 'Initials': 'H', 'LastName': 'Rouhanizadeh', 'Affiliation': 'Department of Pediatrics, Faculty of Medicine, Mazandaran University of Medical Sciences, Sari, Iran.'}, {'ForeName': 'Ghasemali', 'Initials': 'G', 'LastName': 'Khorasani', 'Affiliation': 'Department of Plastic and Reconstructive Surgery, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Seyed Jalal', 'Initials': 'SJ', 'LastName': 'Hosseinimehr', 'Affiliation': 'Department of Radiopharmacy, Faculty of Pharmacy, Mazandaran University of Medical Sciences, Sari, Iran.'}]",International journal of clinical practice,['10.1111/ijcp.13600'] 2395,32603560,Impact of Concurrent Posttraumatic Stress Disorder on Outcomes of Antipsychotic Augmentation for Major Depressive Disorder With a Prior Failed Treatment: VAST-D Randomized Clinical Trial.,"OBJECTIVE To determine whether concurrent posttraumatic stress disorder (PTSD) should affect whether to augment or switch medications when major depressive disorder (MDD) has not responded to a prior antidepressant trial. METHODS Patients at 35 Veterans Health Administration medical centers from December 2012 to May 2015 with nonpsychotic MDD (N = 1,522) and a suboptimal response to adequate antidepressant treatment were randomly assigned to 3 ""next step"" treatments: switching to bupropion, augmenting the current antidepressant with bupropion, and augmenting with the antipsychotic aripiprazole. Blinded ratings with the 16-item Quick Inventory of Depressive Symptomatology-Clinician Rated (QIDS-C₁₆) determined remission and response by 12 weeks and relapse after remission. Survival analyses compared treatment effects in patients with concurrent PTSD diagnosed with the Mini-International Neuropsychiatric Interview (n = 717, 47.1%) and those without PTSD (n = 805, 52.9%). RESULTS Patients diagnosed with PTSD showed more severe depressive symptoms at baseline and were less likely to achieve either remission or response by 12 weeks. Augmentation with aripiprazole was associated with greater likelihood of achieving response (68.4%) than switching to bupropion (57.7%) in patients with PTSD (relative risk [RR] = 1.26; 95% CI, 1.01-1.59) as well as in patients without PTSD (RR = 1.29; 95% CI, 1.05-1.97) (78.9% response with aripiprazole augmentation vs 66.9% with switching to bupropion). Treatment comparisons with the group receiving augmentation with bupropion were not significant. There was no significant interaction between treatment group and PTSD on remission (P = .70), response (P = .98), or relapse (P = .15). CONCLUSIONS Although PTSD was associated with poorer overall outcomes, the presence of concurrent PTSD among Veterans in this trial did not affect the comparative effectiveness of medications on response, remission, or relapse after initial remission. TRIAL REGISTRATION ClinicalTrials.gov identifier: NCT01421342.",2020,"RESULTS Patients diagnosed with PTSD showed more severe depressive symptoms at baseline and were less likely to achieve either remission or response by 12 weeks.","['Patients at 35 Veterans Health Administration medical centers from December 2012 to May 2015 with nonpsychotic MDD (N = 1,522) and a suboptimal response to adequate antidepressant treatment', 'Major Depressive Disorder', 'patients with concurrent PTSD diagnosed with the Mini-International Neuropsychiatric Interview (n = 717, 47.1%) and those without PTSD (n = 805, 52.9', 'concurrent posttraumatic stress disorder (PTSD']","['aripiprazole', 'bupropion', 'bupropion, augmenting the current antidepressant with bupropion, and augmenting with the antipsychotic aripiprazole', 'Antipsychotic Augmentation']","['Depressive Symptomatology-Clinician Rated (QIDS-C₁₆) determined remission and response', 'response, remission, or relapse', 'severe depressive symptoms', 'likelihood of achieving response']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0178672', 'cui_str': 'Health administration'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205420', 'cui_str': 'Concurrent'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C4505426', 'cui_str': 'Mini International Neuropsychiatric Interview'}]","[{'cui': 'C0299792', 'cui_str': 'aripiprazole'}, {'cui': 'C0085208', 'cui_str': 'Bupropion'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant'}, {'cui': 'C0040615', 'cui_str': 'Antipsychotic agent'}, {'cui': 'C0332509', 'cui_str': 'Increased size'}]","[{'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0585291', 'cui_str': 'Four times daily'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0033204', 'cui_str': 'Probability'}]",,0.0645933,"RESULTS Patients diagnosed with PTSD showed more severe depressive symptoms at baseline and were less likely to achieve either remission or response by 12 weeks.","[{'ForeName': 'Somaia', 'Initials': 'S', 'LastName': 'Mohamed', 'Affiliation': 'VA Connecticut Healthcare System, 950 Campbell Ave, Mailstop (182), West Haven, CT 06516. somaia.mohamed@va.gov.'}, {'ForeName': 'Gary R', 'Initials': 'GR', 'LastName': 'Johnson', 'Affiliation': 'VA Connecticut Healthcare System, West Haven, Connecticut, USA.'}, {'ForeName': 'Varadan', 'Initials': 'V', 'LastName': 'Sevilimedu', 'Affiliation': 'VA Connecticut Healthcare System, West Haven, Connecticut, USA.'}, {'ForeName': 'Sanjai D', 'Initials': 'SD', 'LastName': 'Rao', 'Affiliation': 'VA San Diego Healthcare System, San Diego, California, USA.'}, {'ForeName': 'Paul B', 'Initials': 'PB', 'LastName': 'Hicks', 'Affiliation': 'Baylor Scott and White Health, Temple, Texas, USA.'}, {'ForeName': 'Peijun', 'Initials': 'P', 'LastName': 'Chen', 'Affiliation': 'Louis Stokes Cleveland VA Medical Center, Cleveland, Ohio, USA.'}, {'ForeName': 'Kimberly', 'Initials': 'K', 'LastName': 'Lauro', 'Affiliation': 'VA San Diego Healthcare System, San Diego, California, USA.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Jurjus', 'Affiliation': 'Louis Stokes Cleveland VA Medical Center, Cleveland, Ohio, USA.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Pilkinton', 'Affiliation': 'Tuscaloosa VA Medical Center, Tuscaloosa, Alabama, USA.'}, {'ForeName': 'Lori', 'Initials': 'L', 'LastName': 'Davis', 'Affiliation': 'Tuscaloosa VA Medical Center, Tuscaloosa, Alabama, USA.'}, {'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'Wilcox', 'Affiliation': 'Tucson VA Medical Center, Tucson, Arizona, USA.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Iranmanesh', 'Affiliation': 'Salem VA Medical Center, Salem, Virginia, USA.'}, {'ForeName': 'Mamta', 'Initials': 'M', 'LastName': 'Sapra', 'Affiliation': 'Salem VA Medical Center, Salem, Virginia, USA.'}, {'ForeName': 'Muhammad', 'Initials': 'M', 'LastName': 'Aslam', 'Affiliation': 'Cincinnati VA Medical Center, Cincinatti, Ohio, USA.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Michalets', 'Affiliation': 'Charles George VA Medical Center, Asheville, North Carolina, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Thase', 'Affiliation': 'Philadelphia VA Medical Center, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Sidney', 'Initials': 'S', 'LastName': 'Zisook', 'Affiliation': 'VA San Diego Healthcare System, San Diego, California, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': 'The names of all participants in the VAST-D Study are listed in Supplementary Appendix 1.'}]",The Journal of clinical psychiatry,['10.4088/JCP.19m13038'] 2396,32603561,Preventive Cognitive Therapy With Antidepressant Discontinuation During Pregnancy: Results From a Randomized Controlled Trial.,,2020,,[],['Preventive Cognitive Therapy With Antidepressant Discontinuation'],[],[],"[{'cui': 'C0204169', 'cui_str': 'Preventive dental procedure'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}]",[],,0.056871,,"[{'ForeName': 'Nina M', 'Initials': 'NM', 'LastName': 'Molenaar', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, Department of Psychiatry, 1425 Madison Ave, New York, NY 10029. nina.molenaar@mssm.edu.'}, {'ForeName': 'Marlies E', 'Initials': 'ME', 'LastName': 'Brouwer', 'Affiliation': ''}, {'ForeName': 'Huibert', 'Initials': 'H', 'LastName': 'Burger', 'Affiliation': ''}, {'ForeName': 'Astrid M', 'Initials': 'AM', 'LastName': 'Kamperman', 'Affiliation': ''}, {'ForeName': 'Veerle', 'Initials': 'V', 'LastName': 'Bergink', 'Affiliation': ''}, {'ForeName': 'Witte J G', 'Initials': 'WJG', 'LastName': 'Hoogendijk', 'Affiliation': ''}, {'ForeName': 'Alishia D', 'Initials': 'AD', 'LastName': 'Williams', 'Affiliation': ''}, {'ForeName': 'Claudi L H', 'Initials': 'CLH', 'LastName': 'Bockting', 'Affiliation': ''}, {'ForeName': 'Mijke P', 'Initials': 'MP', 'LastName': 'Lambregtse-van den Berg', 'Affiliation': ''}]",The Journal of clinical psychiatry,['10.4088/JCP.19l13099'] 2397,32603613,Randomised comparison of 1.1 GBq and 3.7 GBq radioiodine to ablate the thyroid in the treatment of low-risk thyroid cancer: a 13-year follow-up.,"Purpose: The optimal activity of radioiodine (I-131) administered for ablation therapy in papillary and follicular thyroid cancer after thyroidectomy remains unknown in a long-term (> 10 year) follow-up. Some, shorter follow-up studies suggest that activities 1.1 GBq and 3.7 GBq are equally effective. We evaluated the long-term outcomes after radioiodine treatment to extend current knowledge about the optimal ablative dose of I-131. Methods: One hundred and sixty consecutive adult patients (129 females, 31 males; mean age 46 ± 14 y, range 18-89 y) diagnosed with histologically confirmed differentiated thyroid cancer, were randomised in a prospective, phase III, open-label, single-centre study, to receive either 1.1 GBq or 3.7 GBq of I-131 after thyroidectomy. At randomisation, patients were stratified according to the histologically verified cervical lymph node status and were prepared for ablation using thyroid hormone withdrawal. No uptake in the whole-body scan with I-131 and serum thyroglobulin concentration less than 1 ng/mL at 4-8 months after treatment was considered successful ablation. Results: Median follow-up time was 13.0 years (mean 11.0 ± 4.8 y; range 0.3-17.1 y). Altogether 81 patients received 1.1 GBq with successful ablation in 45 (56%) patients. In the original study, thirty-six patients (44%) needed one or more extra administrations to replete the ablation. Of these, 4 (8.9%) and 5 (14%) patients relapsed during the follow-up, respectively. Of the 79 patients treated with 3.7 GBq 45 (57%) had successful ablation after one administration of radioiodine and 34 (43%) needed several treatments. Of these, 2 (4.4%) and 9 (26.5%) patients relapsed, respectively. The groups did not differ in the proportion of patients relapsing ( p  = .591). Conclusion: During follow-up of median 13 years, 3.7 GBq is not superior to 1.1 GBq in the radioiodine treatment after thyroidectomy in papillary and follicular thyroid cancer.",2020,"During follow-up of median 13 years, 3.7 GBq is not superior to 1.1 GBq in the radioiodine treatment after thyroidectomy in papillary and follicular thyroid cancer.","['low-risk thyroid cancer', 'One hundred and sixty consecutive adult patients (129 females, 31 males; mean age 46\u2009±\u200914\u2009y, range 18-89\u2009y) diagnosed with histologically confirmed differentiated thyroid cancer']","['1.1 GBq and 3.7 GBq radioiodine', 'radioiodine (I-131) administered for ablation therapy', 'radioiodine']","['serum thyroglobulin concentration', 'proportion of patients relapsing', 'successful ablation']","[{'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0007115', 'cui_str': 'Malignant tumor of thyroid gland'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1520439', 'cui_str': '129 Strain Mouse'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C4722172', 'cui_str': 'Primary differentiated carcinoma of thyroid gland'}]","[{'cui': 'C4517491', 'cui_str': '1.1'}, {'cui': 'C1688582', 'cui_str': 'GBq'}, {'cui': 'C4517696', 'cui_str': '3.7'}, {'cui': 'C2828294', 'cui_str': 'iodide ion I-131'}, {'cui': 'C0303029', 'cui_str': 'iodine I-131'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0040123', 'cui_str': 'Thyroglobulin'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}]",160.0,0.027105,"During follow-up of median 13 years, 3.7 GBq is not superior to 1.1 GBq in the radioiodine treatment after thyroidectomy in papillary and follicular thyroid cancer.","[{'ForeName': 'Veera', 'Initials': 'V', 'LastName': 'Ahtiainen', 'Affiliation': 'Department of Radiation Oncology, Comprehensive Cancer Centre, Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Vaalavirta', 'Affiliation': 'Department of Radiation Oncology, Comprehensive Cancer Centre, Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Mikko', 'Initials': 'M', 'LastName': 'Tenhunen', 'Affiliation': 'Department of Radiation Oncology, Comprehensive Cancer Centre, Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Heikki', 'Initials': 'H', 'LastName': 'Joensuu', 'Affiliation': 'Department of Radiation Oncology, Comprehensive Cancer Centre, Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Hanna', 'Initials': 'H', 'LastName': 'Mäenpää', 'Affiliation': 'Department of Radiation Oncology, Comprehensive Cancer Centre, Helsinki University Hospital, Helsinki, Finland.'}]","Acta oncologica (Stockholm, Sweden)",['10.1080/0284186X.2020.1785003'] 2398,32601620,Prospective Evaluation of Effect of Metformin on Activation of AMP-activated Protein Kinase (AMPK) and Disease Control in a Sub-group Analysis of Patients with GI Malignancies.,"Background Observational studies have demonstrated association of metformin with reduced cancer incidence and mortality in multiple cancer types, including gastrointestinal (GI) malignancies. Anti-neoplastic effects of metformin are believed through many mechanisms including activation of AMP-activated protein kinase, which controls mammalian target of rapamycin (mTOR) growth regulatory pathway. Methods In a pilot, delayed-start randomized study, non-diabetic patients with GI cancers were randomized to 2 arms, Stage 1: concurrent metformin (500mg twice daily) plus chemotherapy vs. chemotherapy alone followed by cross over to metformin plus chemotherapy arm in Stage 2, while adverse events (DLT) were assessed by CTCAE v.3.0. As a translational correlate, we used phosphorylation of AMPKα at Thr172 to measure AMPK activation by western blot technique in PBMCs isolated from patients before and after receiving M. These levels were correlated with radiological (RECIST 1.1) and tumor marker outcomes by descriptive analysis. In this study, we present the sub-group analysis of patients with GI cancers. Results 41 patients with GI cancers (colorectal: 22, pancreatic: 12, gastroesophageal: 4, biliary: 2, others: 1) were treated in this trial. Mean duration of metformin therapy was 85 days (range: 9-443). There was no significant difference in grade 3 or above DLT in metformin plus chemotherapy vs. chemotherapy arm (14% vs. 12% respectively). Gel band density analysis on 19 patients showed that 63% patients had increased phosphorylation of AMPKα after metformin (ratio of phospho-AMPKα after and before metformin > 1) with mean = 1.227 (± 0.134). RECIST 1.1 restaging showed disease control in 55% patients and 45% patients had decline in tumor markers. Of note, 60% of patients with disease control also showed increase in phosphorylation of AMKα. Conclusions This group of patients treated with metformin prospectively demonstrates the impact of metformin on AMPKα phosphorylation, and correlates with clinical benefit in patients with GI cancers when metformin was added to systemic chemotherapy of varying types. We aim to perform a dose-escalation of metformin in our next study with additional metabolomics correlates.",2020,RECIST 1.1 restaging showed disease control in 55% patients and 45% patients had decline in tumor markers.,"['Patients with GI Malignancies', 'non-diabetic patients with GI cancers', '41 patients with GI cancers (colorectal: 22, pancreatic: 12, gastroesophageal: 4, biliary: 2, others: 1', 'patients with GI cancers']","['chemotherapy vs. chemotherapy alone followed by cross over to metformin plus chemotherapy', 'Metformin', 'metformin plus chemotherapy vs. chemotherapy', 'metformin']","['Mean duration of metformin therapy', 'phosphorylation of AMPKα', 'disease control']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0685938', 'cui_str': 'Malignant neoplasm of gastrointestinal tract'}, {'cui': 'C0555952', 'cui_str': 'Colorectal'}, {'cui': 'C0030274', 'cui_str': 'Pancreatic structure'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0010366', 'cui_str': 'Genetic crossing over'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0031715', 'cui_str': 'Phosphorylation'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",41.0,0.0235858,RECIST 1.1 restaging showed disease control in 55% patients and 45% patients had decline in tumor markers.,"[{'ForeName': 'Amandeep', 'Initials': 'A', 'LastName': 'Godara', 'Affiliation': 'Tufts Cancer Center, Tufts Medical Center, Boston, MA, USA.'}, {'ForeName': 'Nauman S', 'Initials': 'NS', 'LastName': 'Siddiqui', 'Affiliation': 'Tufts Cancer Center, Tufts Medical Center, Boston, MA, USA.'}, {'ForeName': 'Hilal', 'Initials': 'H', 'LastName': 'Hachem', 'Affiliation': 'Tufts Cancer Center, Tufts Medical Center, Boston, MA, USA.'}, {'ForeName': 'Philip N', 'Initials': 'PN', 'LastName': 'Tsichlis', 'Affiliation': 'Tufts Cancer Center, Tufts Medical Center, Boston, MA, USA.'}, {'ForeName': 'Robert E', 'Initials': 'RE', 'LastName': 'Martell', 'Affiliation': 'Tufts Cancer Center, Tufts Medical Center, Boston, MA, USA.'}, {'ForeName': 'Muhammad Wasif', 'Initials': 'MW', 'LastName': 'Saif', 'Affiliation': 'Tufts Cancer Center, Tufts Medical Center, Boston, MA, USA.'}]",Journal of cellular signaling,['10.33696/Signaling.1.008'] 2399,32601653,Learners' experience and perceived impact of a health literacy program in adult basic education: a qualitative study.,"Objectives and importance of the study: Adult literacy programs aim to empower learners to participate more effectively in everyday life. This includes programs with health content embedded in curricula to target health literacy. Adult learners who attend these programs represent a heterogeneous population, but include a high proportion of hard-to-reach or socially disadvantaged groups in terms of age, ethnicity, educational background, language and prevalence of learning disabilities. In 2014, we conducted a cluster-randomised controlled trial of a health literacy program in adult basic education classes across New South Wales, Australia. This paper reports findings from a qualitative study exploring learners' experience of the course and its perceived impact on their lives, as well as their understanding and confidence about health. STUDY TYPE Qualitative interview study. METHOD We conducted semistructured interviews as part of the evaluation of the 18-week health literacy program, with participants purposively recruited from six health literacy classes (n = 22). Researchers trained in qualitative methods interviewed adult learners either face to face or over the phone using a topic guide. Data was analysed using the Framework method, a matrix-based approach to thematic analysis. RESULTS The majority of interviewees were female, lived in metropolitan areas and were from non-English-speaking backgrounds. Most had existing self-reported health problems and inadequate functional health literacy. Most participants described positive impacts of the health literacy course on their language, literacy and numeracy skills, functional health literacy skills, and health knowledge. They also reported being able to translate this into health actions including interacting with providers, accessing and using healthcare, and managing health and illness (e.g. making healthier food choices). Learners also described positive social outcomes of the course, including feelings of connectedness and interpersonal trust within a new network of learners, and reported sharing new knowledge with others in their communities. CONCLUSIONS The findings add value to existing limited evidence that has demonstrated the untapped potential of adult basic education to develop health literacy skills among socially disadvantaged groups. Learners valued the opportunity to share experiences in structured group learning, and reported confidence to transfer new knowledge into their home and wider social network.",2020,"Most participants described positive impacts of the health literacy course on their language, literacy and numeracy skills, functional health literacy skills, and health knowledge.","['participants purposively recruited from six health literacy classes (n = 22', 'Adult learners who attend these programs represent a heterogeneous population, but include a high proportion of hard-to-reach or socially disadvantaged groups in terms of age, ethnicity, educational background, language and prevalence of learning disabilities', 'adult basic education classes across New South Wales, Australia', 'adult basic education']",['health literacy program'],"['feelings of connectedness and interpersonal trust', 'everyday life', 'health literacy course on their language, literacy and numeracy skills, functional health literacy skills, and health knowledge']","[{'cui': 'C2362527', 'cui_str': 'Health Literacy'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0242960', 'cui_str': 'Heterogeneity, Genetic'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0018599', 'cui_str': 'Hard'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0012613', 'cui_str': 'Disadvantaged'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0015031', 'cui_str': 'Ethnic group'}, {'cui': 'C0013658', 'cui_str': 'Educational achievement'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0751265', 'cui_str': 'Learning disability'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0043015', 'cui_str': 'Wales'}, {'cui': 'C0004340', 'cui_str': 'Australia'}]","[{'cui': 'C2362527', 'cui_str': 'Health Literacy'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0237935', 'cui_str': 'Trust'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C2362527', 'cui_str': 'Health Literacy'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0023864', 'cui_str': 'Literacy'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}]",,0.0422646,"Most participants described positive impacts of the health literacy course on their language, literacy and numeracy skills, functional health literacy skills, and health knowledge.","[{'ForeName': 'Danielle M', 'Initials': 'DM', 'LastName': 'Muscat', 'Affiliation': 'Sydney Health Literacy Lab, School of Public Health, Faculty of Medicine and Health, University of Sydney, NSW, Australia.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Morony', 'Affiliation': 'Sydney Health Literacy Lab, School of Public Health, Faculty of Medicine and Health, University of Sydney, NSW, Australia.'}, {'ForeName': 'Don', 'Initials': 'D', 'LastName': 'Nutbeam', 'Affiliation': 'School of Public Health, Faculty of Medicine and Health, University of Sydney, NSW, Australia.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Ayre', 'Affiliation': 'Sydney Health Literacy Lab, School of Public Health, Faculty of Medicine and Health, University of Sydney, NSW, Australia.'}, {'ForeName': 'Heather L', 'Initials': 'HL', 'LastName': 'Shepherd', 'Affiliation': 'School of Public Health, Faculty of Medicine and Health, University of Sydney, NSW, Australia; School of Psychology, University of Sydney, NSW, Australia.'}, {'ForeName': 'Sian K', 'Initials': 'SK', 'LastName': 'Smith', 'Affiliation': 'Psychosocial Research Group, Prince of Wales Clinical School, Faculty of Medicine, UNSW Sydney, Australia.'}, {'ForeName': 'Haryana M', 'Initials': 'HM', 'LastName': 'Dhillon', 'Affiliation': 'School of Psychology, University of Sydney, NSW, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Hayen', 'Affiliation': 'Faculty of Health, University of Technology Sydney, NSW, Australia.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Luxford', 'Affiliation': 'Clinical Excellence Commission, Sydney, NSW, Australia.'}, {'ForeName': 'Wedyan', 'Initials': 'W', 'LastName': 'Meshreky', 'Affiliation': 'NPS MedicineWise, Sydney, NSW, Australia.'}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'McCaffery', 'Affiliation': 'Sydney Health Literacy Lab, School of Public Health, Faculty of Medicine and Health, University of Sydney, NSW, Australia; kirsten.mccaffery@sydney.edu.au.'}]",Public health research & practice,['10.17061/phrp29231909'] 2400,32601665,Implementation of health education interventions at Dutch music schools.,"A randomized controlled trial was conducted comparing the effects of a biopsychosocial course (PRESTO-Play) vs. physical activity promotion (PRESTO-Fit) to reduce disability related to musculoskeletal disorders in music students. The current study provides an external validation and a formative and process evaluation, allowing for a better interpretation of results. First, a group of experts was asked to complete a structured evaluation of design and content of the trial. Second, quantitative and qualitative data were analysed from different stakeholders (students, therapists and conservatory staff) using questionnaires, logs, field notes and emails to evaluate fidelity, dose delivered, dose received, reach and context. Results are presented descriptively. Two authors independently identified key responses that were merged into themes. Although no difference in disability was found between interventions, closer evaluation revealed that participants in PRESTO-Play reported that they learned about prevention of physical complaints and were more satisfied with course contents compared with PRESTO-Fit. Study design and contents of the interventions were found to be valid, with an appropriate dose delivered. Feedback from students and logs suggested that behavioural change and psychosocial principles in PRESTO-Play might have not been implemented optimally. Only moderate fidelity in both groups and too little contrast between interventions could have influenced results. Low attendance rates and a presumed lack of generalization further decreased possible effectiveness. Context greatly influenced implementation. Implementing a future health course with closer collaboration with the institution could optimize accessibility and communication, encourage attendance and enhance motivation for behavioural change.",2020,"Although no difference in disability was found between interventions, closer evaluation revealed that participants in PRESTO-Play reported that they learned about prevention of physical complaints and were more satisfied with course contents compared with PRESTO-Fit.","['Dutch music schools', 'music students']","['biopsychosocial course (PRESTO-Play) vs. physical activity promotion (PRESTO-Fit', 'health education interventions']","['Low attendance rates', 'disability']","[{'cui': 'C0013331', 'cui_str': 'Dutch'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0038492', 'cui_str': 'Student'}]","[{'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0036572', 'cui_str': 'Seizure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0237484', 'cui_str': 'School attendance'}, {'cui': 'C0231170', 'cui_str': 'Disability'}]",2.0,0.0518353,"Although no difference in disability was found between interventions, closer evaluation revealed that participants in PRESTO-Play reported that they learned about prevention of physical complaints and were more satisfied with course contents compared with PRESTO-Fit.","[{'ForeName': 'Vera A E', 'Initials': 'VAE', 'LastName': 'Baadjou', 'Affiliation': 'Department of Rehabilitation Medicine, Adelante Centre of Expertise in Rehabilitation and Audiology, zandbergsweg 111, 6432 CC, Hoensbroek, The Netherlands.'}, {'ForeName': 'Bronwen J', 'Initials': 'BJ', 'LastName': 'Ackermann', 'Affiliation': 'Discipline of Biomedical Science, School of Medical Sciences, Sydney University, Sydney, Australia.'}, {'ForeName': 'Jeanine A M C F', 'Initials': 'JAMCF', 'LastName': 'Verbunt', 'Affiliation': 'Department of Rehabilitation Medicine, Adelante Centre of Expertise in Rehabilitation and Audiology, zandbergsweg 111, 6432 CC, Hoensbroek, The Netherlands.'}, {'ForeName': 'Marjon D F', 'Initials': 'MDF', 'LastName': 'van Eijsden-Besseling', 'Affiliation': 'Department of Rehabilitation Medicine, Care and Public Health Research Institute, Maastricht University, Universiteitssingel 40, 6229 ER, Postal Box 616, 6200 Maastricht, The Netherlands.'}, {'ForeName': 'Rob A', 'Initials': 'RA', 'LastName': 'de Bie', 'Affiliation': 'Department of Epidemiology, Musculoskeletal Group, Care And Public Health Research Institute, Maastricht University, Universiteitssingel 40, 6229 ER, Postal Box 616, 6200 Maastricht, The Netherlands.'}, {'ForeName': 'Rob J E M', 'Initials': 'RJEM', 'LastName': 'Smeets', 'Affiliation': 'Department of Rehabilitation Medicine, Care and Public Health Research Institute, Maastricht University, Universiteitssingel 40, 6229 ER, Postal Box 616, 6200 Maastricht, The Netherlands.'}]",Health promotion international,['10.1093/heapro/daaa050'] 2401,32601670,Development of a novel mind-body activity and pain management program for older adults with cognitive decline.,"BACKGROUND AND OBJECTIVES Chronic pain (CP) and cognitive decline (CD) often cooccur in older adults, which can reinforce a ""disability spiral"". Early interventions teaching pain coping skills and gradual increases in activity (walking) are needed to promote overall wellbeing and potentially delay further decline of cognition and daily functioning. The goal of this mixed-methods study was to guide the development of two mind-body activity programs for CP and CD which focus on increasing walking using time goals (Active Brains) or step-count reinforced by a Fitbit (Active Brains-Fitbit). RESEARCH DESIGN AND METHODS Older adults with CP and CD (N = 23) participated in a one-time focus group (four total) and completed measures of physical, emotional, and cognitive functioning. Qualitative analyses identified population-specific needs, preferences, and perceptions of proposed program skills. Quantitative analysis compared clinical characteristics to population norms and explore intercorrelations among treatment targets. RESULTS Thematic analyses revealed six main themes: (1) challenges living with CP and (2) CD, (3) current walking, (4) technology (Fitbit) to increase walking, (5) perceptions of proposed program skills (e.g., mind-body, pain, increased walking), and (6) program barriers and facilitators. Quantitative analyses showed that: (1) participants had physical function below reference values, and (2) higher self-efficacy correlated with higher cognitive, emotional, and physical functioning. DISCUSSION AND IMPLICATIONS Focus group participants were enthusiastic about the proposed program skills. Current work includes open pilot testing, qualitative interviews, and a small randomized controlled trial to optimize the programs and methodology in preparation for efficacy testing against an educational control.",2020,"Quantitative analyses showed that: (1) participants had physical function below reference values, and (2) higher self-efficacy correlated with higher cognitive, emotional, and physical functioning. ","['older adults with cognitive decline', 'older adults', 'Older adults with CP and CD (N = 23']",['novel mind-body activity and pain management program'],"['challenges living with CP and (2) CD, (3) current walking, (4) technology (Fitbit) to increase walking, (5) perceptions of proposed program skills (e.g., mind-body, pain, increased walking), and (6) program barriers and facilitators', 'activity (walking', 'cognitive, emotional, and physical functioning']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0234985', 'cui_str': 'Mental Deterioration'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0234985', 'cui_str': 'Mental Deterioration'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",23.0,0.0267041,"Quantitative analyses showed that: (1) participants had physical function below reference values, and (2) higher self-efficacy correlated with higher cognitive, emotional, and physical functioning. ","[{'ForeName': 'Ryan A', 'Initials': 'RA', 'LastName': 'Mace', 'Affiliation': 'Massachusetts General Hospital, Integrated Brain Health Clinical and Research Program, Boston, MA, USA.'}, {'ForeName': 'Melissa V', 'Initials': 'MV', 'LastName': 'Gates', 'Affiliation': 'Massachusetts General Hospital, Integrated Brain Health Clinical and Research Program, Boston, MA, USA.'}, {'ForeName': 'Breanna', 'Initials': 'B', 'LastName': 'Bullard', 'Affiliation': 'Massachusetts General Hospital, Integrated Brain Health Clinical and Research Program, Boston, MA, USA.'}, {'ForeName': 'Ethan G', 'Initials': 'EG', 'LastName': 'Lester', 'Affiliation': 'Massachusetts General Hospital, Integrated Brain Health Clinical and Research Program, Boston, MA, USA.'}, {'ForeName': 'Ilyssa H', 'Initials': 'IH', 'LastName': 'Silverman', 'Affiliation': 'Massachusetts General Hospital, Integrated Brain Health Clinical and Research Program, Boston, MA, USA.'}, {'ForeName': 'Yakeel T', 'Initials': 'YT', 'LastName': 'Quiroz', 'Affiliation': 'Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'Ana-Maria', 'Initials': 'AM', 'LastName': 'Vranceanu', 'Affiliation': 'Massachusetts General Hospital, Integrated Brain Health Clinical and Research Program, Boston, MA, USA.'}]",The Gerontologist,['10.1093/geront/gnaa084'] 2402,32601731,Metformin use in prediabetes: is earlier intervention better?,"AIM The aim of this study was to investigate the effectiveness of metformin in diabetes prevention in a prediabetic population across a range of fasting plasma glucose (FPG) levels at baseline. A secondary aim was to assess the effectiveness of metformin in preventing diabetes in those participants where impaired fasting glucose (IFG) was relatively more pronounced as opposed to impaired glucose tolerance (IGT). METHODS Participants randomised to metformin and placebo arms in the Diabetes Prevention Program study were stratified into cohorts according to level of FPG at baseline. Cumulative incidence of diabetes for the different cohorts was assessed. Change in FPG, insulin sensitivity, and levels of fasting insulin and proinsulin for the different cohorts were also calculated. RESULTS The largest reductions in incidence of diabetes and FPG occurred within prediabetic persons with a higher level of FPG at baseline. Metformin was able to stabilise insulin sensitivity in every stratified sub-cohort except one. Sub-cohorts which had higher levels of insulin sensitivity at baseline experienced the largest increases in insulin sensitivity. Metformin reduced the incidence of diabetes by 43% (RR 0.57, CI 0.4-0.9) in those prediabetic persons whose IFG was more pronounced compared to a 26% (RR 0.74 CI 0.7-0.8) when all participants in the study were included. CONCLUSION The largest reductions in both incidence of diabetes and FPG occurred in prediabetic persons with a higher level of FPG at baseline. Metformin was able to stabilise insulin sensitivity and was more effective in persons with more pronounced IFG.",2020,"Metformin reduced the incidence of diabetes by 43% (RR 0.57, CI 0.4-0.9) in those prediabetic persons whose IFG was more pronounced compared to a 26% (RR 0.74 CI 0.7-0.8) when all participants in the study were included. ",['prediabetes'],"['Metformin', 'metformin and placebo', 'metformin']","['incidence of diabetes and FPG', 'incidence of diabetes', 'stabilise insulin sensitivity', 'Cumulative incidence of diabetes', 'Change in FPG, insulin sensitivity, and levels of fasting insulin and proinsulin', 'insulin sensitivity', 'glucose tolerance (IGT', 'diabetes and FPG', 'fasting plasma glucose (FPG) levels', 'fasting glucose (IFG']","[{'cui': 'C0271650', 'cui_str': 'Impaired glucose tolerance'}]","[{'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0033362', 'cui_str': 'Proinsulin'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C0271650', 'cui_str': 'Impaired glucose tolerance'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}]",,0.0413712,"Metformin reduced the incidence of diabetes by 43% (RR 0.57, CI 0.4-0.9) in those prediabetic persons whose IFG was more pronounced compared to a 26% (RR 0.74 CI 0.7-0.8) when all participants in the study were included. ","[{'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Warrilow', 'Affiliation': 'University of Canberra, Locked Bag 1, Canberra, ACT, 2601, Australia. andrew.warrilow@canberra.edu.au.'}, {'ForeName': 'Shawn', 'Initials': 'S', 'LastName': 'Somerset', 'Affiliation': 'University of Canberra, Locked Bag 1, Canberra, ACT, 2601, Australia.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Pumpa', 'Affiliation': 'University of Canberra, Locked Bag 1, Canberra, ACT, 2601, Australia.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Fleet', 'Affiliation': 'The Australian National University, Canberra, ACT, 2600, Australia.'}]",Acta diabetologica,['10.1007/s00592-020-01559-9'] 2403,32601796,"Safety and efficacy of temsirolimus in combination with three different immuno-chemotherapy regimens in relapse and refractory mantle cell lymphoma, final results of the T 3 phase IB trial of the LYSA.","Mantle cell lymphoma has a dismal prognosis at relapse or in the refractory setting. Among therapies, mTor pathway targeting by temsirolimus has been the first strategy approved for relapse in Europe. While its efficacy in monotherapy has long been demonstrated, its use remains limited. In the T 3 phase Ib clinical trial, we investigated the recommended dose of temsirolimus in association with R-CHOP (R-CHOP-T), or high-dose cytarabine plus rituximab (R-DHA-T), or fludarabine, cyclophosphamide plus rituximab (R-FC-T). From November 11, 2011 to February 26, 2015, forty-one patients were enrolled. Patients presented with high MIPI (47.5%) at relapse and a median number of treatments of 1 (1-3). Patients were treated by R-CHOP-T (n = 10), R-FC-T (n = 14), or R-DHA-T (n = 17) according to the choice of local investigators. The maximum tolerated dose (MTD) was 15 mg in the R-CHOP-T arm and has not been determined in other treatment arms because of toxicities. All patients experienced ≥ Grade 3 adverse events, mainly thrombocytopenia (76%). Twenty-six patients discontinued prematurely the treatment, mostly for toxicity (n = 12) and progression of the disease (n = 8). Of note, 6 patients of the R-DHA-T arm reached complete remission (35%). Temsirolimus with immuno-chemotherapy is associated with a high rate of toxicities. Determination of MTD could only be achieved for R-CHOP-T arm. Associations between temsirolimus and other targeted therapies may be warranted for R/R MCL patients.",2020,"Twenty-six patients discontinued prematurely the treatment, mostly for toxicity (n = 12) and progression of the disease (n = 8).","['Twenty-six patients discontinued prematurely the treatment, mostly for toxicity (n\u2009=\u200912) and progression of the disease (n\u2009=\u20098', 'From November 11, 2011 to February 26, 2015, forty-one patients were enrolled']","['temsirolimus', 'cytarabine plus rituximab (R-DHA-T), or fludarabine, cyclophosphamide plus rituximab', 'Temsirolimus with immuno-chemotherapy']","['complete remission', 'Safety and efficacy', '≥ Grade 3 adverse events, mainly thrombocytopenia', 'maximum tolerated dose (MTD']","[{'cui': 'C0450349', 'cui_str': '26'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C1707080', 'cui_str': 'temsirolimus'}, {'cui': 'C0010711', 'cui_str': 'Cytarabine'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0142831', 'cui_str': 'sodium dehydroacetate'}, {'cui': 'C0059985', 'cui_str': 'fludarabine'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0278348', 'cui_str': 'Immunotherapy for cancer'}]","[{'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0040034', 'cui_str': 'Thrombocytopenic disorder'}, {'cui': 'C0752079', 'cui_str': 'Maximal Tolerated Dose'}]",41.0,0.0540781,"Twenty-six patients discontinued prematurely the treatment, mostly for toxicity (n = 12) and progression of the disease (n = 8).","[{'ForeName': 'Benoît', 'Initials': 'B', 'LastName': 'Tessoulin', 'Affiliation': 'Department of Hematology, CHU de Nantes, University Hospital of Nantes, Nantes, France.'}, {'ForeName': 'Kamal', 'Initials': 'K', 'LastName': 'Bouabdallah', 'Affiliation': 'Haematology, CHU de Bordeaux, Bordeaux, France.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Burroni', 'Affiliation': 'Pathology Department, Cochin University Hospital, AP-HP, Paris, France.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Lamy', 'Affiliation': 'INSERM U917, CHU Pontchaillou, Rennes, France.'}, {'ForeName': 'Remy', 'Initials': 'R', 'LastName': 'Gressin', 'Affiliation': 'Hematology, CHU Grenoble, Grenoble, Grenoble, France.'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Cartron', 'Affiliation': 'Department of clinical hematology, University Hospital Montpellier, Montpellier, France.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Thieblemont', 'Affiliation': 'Hôpital Saint-Louis, Paris, France.'}, {'ForeName': 'Clémentine', 'Initials': 'C', 'LastName': 'Sarkozy', 'Affiliation': 'Hematology, Hospices Civils de Lyon, Pierre Bénite, Lyon, France.'}, {'ForeName': 'Corinne', 'Initials': 'C', 'LastName': 'Haioun', 'Affiliation': 'Lymphoid Malignancies Unit, AP-HP, Groupe Hospitalier Mondor, Croéteil, France.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Casasnovas', 'Affiliation': 'Hematology Department, Hopital Le Bocage, CHU Dijon, Dijon, France.'}, {'ForeName': 'Clementine', 'Initials': 'C', 'LastName': 'Joubert', 'Affiliation': 'Department of Biostatistics, LYSARC, Lyon, France.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Gyan', 'Affiliation': ""Service d'Hématologie et thérapie cellulaire, Centre Hospitalier Universitaire, Tours, France.""}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Hermine', 'Affiliation': 'Hematology Department, Necker University Hospital, AP-HP, Paris, France.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Le Gouill', 'Affiliation': 'Department of Hematology, CHU de Nantes, University Hospital of Nantes, Nantes, France. steven.legouill@chu-nantes.fr.'}]",Annals of hematology,['10.1007/s00277-020-04159-3'] 2404,32601816,Correction to: The Protective Effects of Butorphanol on Pulmonary Function of Patients with Obesity Undergoing Laparoscopic Bariatric Surgery: A Double-Blind Randomized Controlled Trial.,In the original article some of the references were ordered incorrectly.,2020,In the original article some of the references were ordered incorrectly.,['Patients with Obesity Undergoing Laparoscopic Bariatric Surgery'],['Butorphanol'],['Pulmonary Function'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C1456587', 'cui_str': 'Metabolic surgery'}]","[{'cui': 'C0006491', 'cui_str': 'Butorphanol'}]","[{'cui': 'C0231921', 'cui_str': 'Pulmonary function'}]",,0.375577,In the original article some of the references were ordered incorrectly.,"[{'ForeName': 'Xiu-Li', 'Initials': 'XL', 'LastName': 'Wang', 'Affiliation': 'Jiangsu Province Key Laboratory of Anesthesiology, Xuzhou Medical University, Xuzhou, Jiangsu, China.'}, {'ForeName': 'Si', 'Initials': 'S', 'LastName': 'Zeng', 'Affiliation': ""Department of Anesthesiology, Sichuan Academy of Medical Science & Sichuan Provincial People's Hospital, University of Electronic Science and Technology of China, Chengdu, Sichuan, China.""}, {'ForeName': 'Xiao-Xiao', 'Initials': 'XX', 'LastName': 'Li', 'Affiliation': 'Jiangsu Province Key Laboratory of Anesthesiology, Xuzhou Medical University, Xuzhou, Jiangsu, China.'}, {'ForeName': 'Ye', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'Jiangsu Province Key Laboratory of Anesthesiology, Xuzhou Medical University, Xuzhou, Jiangsu, China.'}, {'ForeName': 'Xing-He', 'Initials': 'XH', 'LastName': 'Wang', 'Affiliation': 'Jiangsu Province Key Laboratory of Anesthesiology, Xuzhou Medical University, Xuzhou, Jiangsu, China.'}, {'ForeName': 'Tong', 'Initials': 'T', 'LastName': 'Li', 'Affiliation': 'Jiangsu Province Key Laboratory of Anesthesiology, Xuzhou Medical University, Xuzhou, Jiangsu, China.'}, {'ForeName': 'Su', 'Initials': 'S', 'LastName': 'Liu', 'Affiliation': 'Jiangsu Province Key Laboratory of Anesthesiology, Xuzhou Medical University, Xuzhou, Jiangsu, China. w15996933165@163.com.'}]",Obesity surgery,['10.1007/s11695-020-04821-9'] 2405,32601853,Effect of prolonged expressive writing on health outcomes in breast cancer patients receiving chemotherapy: a multicenter randomized controlled trial.,"PURPOSE This study aims to evaluate the effects of prolonged expressive writing on health outcomes in breast cancer patients undergoing chemotherapy to help understand how the dosage of an expressive writing intervention might moderate its effects. METHODS A total of 112 breast cancer patients undergoing chemotherapy were randomly allocated to the expressive writing group (n = 56) or the prolonged expressive writing group (n = 56). The expressive writing group received the standard expressive writing intervention based on Pennebaker's prompt to write for at least 20 min over four consecutive days (4 sessions). The prolonged expressive writing group used a modified prompt: write for at least 20 min 3 times a week over a 4-week period (12 sessions); patients could choose whether to write on consecutive days or not. All participants were required to write about their stressor-related upsetting or traumatic feelings about breast cancer. Outcomes were assessed and compared at baseline, as well as 1 month, 3 months, and 6 months postintervention. RESULTS There was no significant difference in the patients' quality of life, or physical and psychological wellbeing between the expressive writing group and the prolonged expressive writing group at any time point (all p > .05). The quality of life of breast cancer patients significantly decreased in the two groups over time (F = 40.64, p < .001). CONCLUSION Our findings suggest that the writing dosage does not moderate the effects of expressive writing on breast cancer patients undergoing chemotherapy. TRIAL REGISTRATION ChiCTR1800016278.",2020,"There was no significant difference in the patients' quality of life, or physical and psychological wellbeing between the expressive writing group and the prolonged expressive writing group at any time point (all p > .05).","['breast cancer patients receiving', '112 breast cancer patients undergoing chemotherapy', 'breast cancer patients undergoing chemotherapy', 'breast cancer patients undergoing']","['chemotherapy', 'expressive writing group (n\u2009=\u200956) or the prolonged expressive writing group', 'standard expressive writing intervention', 'prolonged expressive writing']","['quality of life of breast cancer patients', ""patients' quality of life, or physical and psychological wellbeing"", 'health outcomes']","[{'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0018582', 'cui_str': 'Handwriting'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",112.0,0.0496424,"There was no significant difference in the patients' quality of life, or physical and psychological wellbeing between the expressive writing group and the prolonged expressive writing group at any time point (all p > .05).","[{'ForeName': 'Yanni', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'Nanfang Hospital, Southern Medical University, NO.1838 North Guangzhou Avenue, Baiyun District, Guangzhou City, Guangdong Province, China.'}, {'ForeName': 'Liping', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Nanfang Hospital, Southern Medical University, NO.1838 North Guangzhou Avenue, Baiyun District, Guangzhou City, Guangdong Province, China.'}, {'ForeName': 'Wanting', 'Initials': 'W', 'LastName': 'Zheng', 'Affiliation': ""Affiliated Hospital of Guangdong Medical University, Zhanjiang, Guangdong, People's Republic of China.""}, {'ForeName': 'Chunrao', 'Initials': 'C', 'LastName': 'Zheng', 'Affiliation': ""Shenzhen People's Hospital, Shenzhen, Guangdong, People's Republic of China.""}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Xu', 'Affiliation': ""Cancer Center of Guangzhou Medical University, Guangzhou, Guangdong, People's Republic of China.""}, {'ForeName': 'Xiaohong', 'Initials': 'X', 'LastName': 'Chen', 'Affiliation': ""The First Affiliated Hospital of Shantou University Medical College, Shantou, Guangdong, People's Republic of China.""}, {'ForeName': 'Wenji', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'Nanfang Hospital, Southern Medical University, NO.1838 North Guangzhou Avenue, Baiyun District, Guangzhou City, Guangdong Province, China.'}, {'ForeName': 'Lijun', 'Initials': 'L', 'LastName': 'Xie', 'Affiliation': ""Affiliated Hospital of Guangdong Medical University, Zhanjiang, Guangdong, People's Republic of China.""}, {'ForeName': 'Pengyan', 'Initials': 'P', 'LastName': 'Zhang', 'Affiliation': ""Shenzhen People's Hospital, Shenzhen, Guangdong, People's Republic of China.""}, {'ForeName': 'Xiaoli', 'Initials': 'X', 'LastName': 'Zhu', 'Affiliation': ""Cancer Center of Guangzhou Medical University, Guangzhou, Guangdong, People's Republic of China.""}, {'ForeName': 'Chuanglian', 'Initials': 'C', 'LastName': 'Zhan', 'Affiliation': ""The First Affiliated Hospital of Shantou University Medical College, Shantou, Guangdong, People's Republic of China.""}, {'ForeName': 'Chunlan', 'Initials': 'C', 'LastName': 'Zhou', 'Affiliation': 'Nanfang Hospital, Southern Medical University, NO.1838 North Guangzhou Avenue, Baiyun District, Guangzhou City, Guangdong Province, China. lanchun200488@126.com.'}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-020-05590-y'] 2406,32601978,Variety Salience and Enjoyment of Repetitiously Consumed Foods: a Field Experiment.,"BACKGROUND The formation of healthy eating habits is supported by repeatedly eating specific foods, but repetition can also reduce enjoyment of those foods. Making the variety in one's diet salient increases enjoyment of repetitiously consumed foods in a lab setting. Therefore, in a longitudinal field experiment, we tested a brief intervention to remind participants of the variety in their diet. We hypothesized that increasing salience of dietary variety would prevent declines in enjoyment of the food and increase the likelihood that participants would be willing to eat the food again later. METHOD Participants (n = 139) ate a granola bar each day for 2 weeks. Before eating it, participants randomly assigned to the treatment condition recalled other recently consumed foods (to increase salience of dietary variety). Control subjects recalled variety in an unrelated domain (music). Participants reported their enjoyment of the granola bar after they ate it each day, and in a lab session after the study ended, the number of granola bars they took from a selection of snacks was counted. RESULTS Self-reported feelings of enjoyment declined steadily, and contrary to our first hypothesis, increasing salience of dietary variety did not prevent this decline. Increasing salience of dietary variety did increase the likelihood that participants would choose to take the same kind of granola bar 2 weeks later. CONCLUSION Brief exercises that make variety in one's diet more salient may not prevent reductions in enjoyment of a repetitiously consumed food, but may still support continued consumption of the food.",2020,"Self-reported feelings of enjoyment declined steadily, and contrary to our first hypothesis, increasing salience of dietary variety did not prevent this decline.","['Participants (n\u2009', 'healthy eating habits', 'remind participants of the variety in their diet']",['Variety Salience and Enjoyment of Repetitiously Consumed Foods'],[],"[{'cui': 'C0452415', 'cui_str': 'Healthy diet'}, {'cui': 'C0018464', 'cui_str': 'Habits'}, {'cui': 'C0557033', 'cui_str': 'Reminding'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}]","[{'cui': 'C0679105', 'cui_str': 'Pleasure'}, {'cui': 'C0016452', 'cui_str': 'Foods'}]",[],,0.0249344,"Self-reported feelings of enjoyment declined steadily, and contrary to our first hypothesis, increasing salience of dietary variety did not prevent this decline.","[{'ForeName': 'Richie L', 'Initials': 'RL', 'LastName': 'Lenne', 'Affiliation': 'Department of Psychology, University of Minnesota, 75 E River Road, Minneapolis, MN, 55454, USA.'}, {'ForeName': 'Traci', 'Initials': 'T', 'LastName': 'Mann', 'Affiliation': 'Department of Psychology, University of Minnesota, 75 E River Road, Minneapolis, MN, 55454, USA. mann@umn.edu.'}, {'ForeName': 'Rachel J', 'Initials': 'RJ', 'LastName': 'Burns', 'Affiliation': 'Carleton University, Ottawa, Canada.'}, {'ForeName': 'Zata', 'Initials': 'Z', 'LastName': 'Vickers', 'Affiliation': 'Department of Psychology, University of Minnesota, 75 E River Road, Minneapolis, MN, 55454, USA.'}, {'ForeName': 'Joseph P', 'Initials': 'JP', 'LastName': 'Redden', 'Affiliation': 'Department of Psychology, University of Minnesota, 75 E River Road, Minneapolis, MN, 55454, USA.'}]",International journal of behavioral medicine,['10.1007/s12529-020-09916-2'] 2407,32601985,The effects of suppressing the biological stress systems on social threat-assessment following acute stress.,"RATIONALE Stress is associated with increased sensitivity to threat. Previous investigations examining how stress affects threat processing have largely focused on biomarker responses associated with either the sympathetic-nervous-system (SNS) or the hypothalamus-pituitary-adrenal (HPA) axis. OBJECTIVES We pharmacologically suppressed activations of SNS, HPA, or both, prior to stress and investigated how each stress system modulates social threat assessment. METHODS One hundred sixty-one healthy men and women were randomized in a between-subject design, to one of four pharmacological or placebo conditions: dexamethasone-placebo, placebo-propranolol, dexamethasone-propranolol, or placebo-placebo. Participants provided threat assessments for angry and neutral human faces on a baseline day, and immediately after stress induction on a testing day. RESULTS With both systems responding normally to stress (placebo-placebo), threat assessment was higher for neutral faces compared with angry. Compared with placebo, SNS suppression resulted in increased threat assessment for angry faces. HPA suppression resulted in decreased threat assessment for neutral and angry faces. When both systems were suppressed, there was an increase in threat assessment for angry faces, and no difference from placebo for neutral. CONCLUSION Our findings demonstrated that when intact, the biological stress systems adaptively support organisms during stress by focusing attention towards specific stimuli that are relevant to the threat. Dysregulations of the stress systems result in important system specific consequences on threat evaluation, such that suppression of either stress system alone resulted in reduced threat assessment for contextually relevant threatening stimuli, whereas when both systems were suppressed, individuals appear indiscriminately attentive to all potential threats in the environment, resulting in increased threat processing of both contextually relevant and irrelevant stimuli. Given that stress-related psychopathologies have been associated with dysregulations of the stress systems and biased responses to social threat, a systematic understanding of the mechanisms that underlie how stress systems modulate social threat assessment is needed, and can provide important insights into the cognitive processes that are involved in the development and maintenance of stress-related psychopathologies.",2020,"When both systems were suppressed, there was an increase in threat assessment for angry faces, and no difference from placebo for neutral. ","['acute stress', 'One hundred sixty-one healthy men and women']","['stress (placebo-placebo', 'placebo, SNS suppression', 'placebo', 'placebo conditions: dexamethasone-placebo, placebo-propranolol, dexamethasone-propranolol, or placebo-placebo']","['threat assessment for neutral and angry faces', 'HPA suppression', 'threat assessment for angry faces']","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C4517832', 'cui_str': '61'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0039044', 'cui_str': 'Sympathetic nervous system structure'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0033497', 'cui_str': 'Propranolol'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0002957', 'cui_str': 'Feeling angry'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0020663', 'cui_str': 'Hypothalamic structure'}, {'cui': 'C0032002', 'cui_str': 'Disorder of pituitary gland'}, {'cui': 'C0271738', 'cui_str': 'Hypocortisolism secondary to another disorder'}]",161.0,0.0668689,"When both systems were suppressed, there was an increase in threat assessment for angry faces, and no difference from placebo for neutral. ","[{'ForeName': 'Nida', 'Initials': 'N', 'LastName': 'Ali', 'Affiliation': 'Department of Psychology, McGill University, 2001 Avenue McGill College, Montreal, H3A 1G1, Canada. nida.ali@mail.mcgill.ca.'}, {'ForeName': 'Cory', 'Initials': 'C', 'LastName': 'Cooperman', 'Affiliation': 'Department of Psychology, McGill University, 2001 Avenue McGill College, Montreal, H3A 1G1, Canada.'}, {'ForeName': 'Jonas P', 'Initials': 'JP', 'LastName': 'Nitschke', 'Affiliation': 'Department of Psychology, McGill University, 2001 Avenue McGill College, Montreal, H3A 1G1, Canada.'}, {'ForeName': 'Mark W', 'Initials': 'MW', 'LastName': 'Baldwin', 'Affiliation': 'Department of Psychology, McGill University, 2001 Avenue McGill College, Montreal, H3A 1G1, Canada.'}, {'ForeName': 'Jens C', 'Initials': 'JC', 'LastName': 'Pruessner', 'Affiliation': 'Faculty of Medicine, McGill Centre for Studies in Aging, McGill University, Montreal, Canada.'}]",Psychopharmacology,['10.1007/s00213-020-05591-z'] 2408,32602000,Contrast-enhanced ultrasonography and blue dye methods in detection of sentinel lymph nodes following neoadjuvant chemotherapy in initially node positive breast cancer.,"BACKGROUND Recent studies show that contrast-enhanced ultrasonography (CEUS) using SonoVue has the potential to improve the performance of sentinel lymph node biopsy (SLNB) in patients with early breast cancer. However, the evidence of SLNB using CEUS in patients converting from cN1 to cN0 after neoadjuvant chemotherapy (NAC) is lacking. The aim of this prospective study is to evaluate the feasibility of CEUS using SonoVue for the identification of sentinel lymph node (SLN) and the value of the combination of CEUS and blue dye (BD) for SLNB in patients converting from cN1 to cN0 following NAC. METHODS Patients with cytology-proven node positive breast cancer at the initial diagnosis (stage T1-T3N1M0) from January 2018 to January 2019, underwent NAC. Patients converting from cN1 to cN0 following NAC were enrolled and randomized into two groups for SLNB: the combination method group using CEUS and BD together, and the single BD method group. Then all patients underwent complete axillary lymph node dissection (ALND) and primary breast surgery. Compared with the final pathological results, the identification rate, sensitivity, specificity, accuracy, false negative rate, negative predictive value, positive predictive value were recorded and compared between two methods. RESULTS A total of 400 patients with stage T1-T3N1M0 disease underwent NAC between January 2018 to January 2019, among which 134 (33.5%) patients had clinically negative node confirmed by imaging after NAC and randomized into two groups. Each group included 67 cases. In the combination method group, contrast-enhanced lymphatic vessels in 66 cases of 67 were clearly visualized by US soon after the periareolar injection of SonoVue and the SLNs were accurately localized. The identification rate of the combination method was 98.5%%, which was significantly higher than 83.6% (56/67) using the single BD method. The mean numbers of SLNs identified by the combination method was higher than that by the single BD method. Compared with pathological diagnosis, sensitivity, specificity, accuracy, the positive predictive value, the negative predictive value, and the FNR of the combingation method were 84.4%, 100%, 89.4%, 100%, 75%, and 15.6%, respectively. In contrast, sensitivity, specificity, accuracy, the positive predictive value, the negative predictive value, and the FNR using single blue dye were 73.9%, 100%, 89.3%, 100%, 84.6%, and 26.1%, respectively. The FNR using the combination method was significantly lower than that using single BD. CONCLUSION Identification of SLNs in patients converting from cN1 to cN0 following NAC by CEUS is a technically feasible. The combination of CEUS and BD is more effective than BD alone for SLNB in patients converting from cN1 to cN0 following NAC.",2020,"Compared with the final pathological results, the identification rate, sensitivity, specificity, accuracy, false negative rate, negative predictive value, positive predictive value were recorded and compared between two methods. ","['initially node positive breast cancer', '400 patients with stage T1-T3N1M0 disease underwent NAC between January 2018 to January 2019, among which 134 (33.5', 'Patients with cytology-proven node positive breast cancer at the initial diagnosis (stage T1-T3N1M0) from January 2018 to January 2019, underwent NAC', 'patients converting from cN1 to cN0 following NAC', 'Patients converting from cN1 to cN0 following NAC', 'patients converting from cN1 to cN0 after neoadjuvant chemotherapy (NAC', 'patients with early breast cancer']","['SLNB: the combination method group using CEUS', 'CEUS', 'CEUS and BD', 'CEUS and blue dye (BD', 'complete axillary lymph node dissection (ALND) and primary breast surgery', 'Contrast-enhanced ultrasonography and blue dye methods', 'neoadjuvant chemotherapy', 'contrast-enhanced ultrasonography (CEUS']","['identification rate, sensitivity, specificity, accuracy, false negative rate, negative predictive value, positive predictive value', 'mean numbers of SLNs', 'sensitivity, specificity, accuracy, the positive predictive value, the negative predictive value, and the FNR of the combingation method', 'sensitivity, specificity, accuracy, the positive predictive value']","[{'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C3160887', 'cui_str': 'Node-positive breast cancer'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C4517565', 'cui_str': '134'}, {'cui': 'C0010818', 'cui_str': 'Cytology'}, {'cui': 'C0456369', 'cui_str': 'Proven'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}]","[{'cui': 'C0796693', 'cui_str': 'Sentinel lymph node biopsy'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C1260957', 'cui_str': 'Blue color'}, {'cui': 'C0013343', 'cui_str': 'Dye'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0193867', 'cui_str': 'Excision of axillary lymph nodes'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0851312', 'cui_str': 'Breast surgery'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0020792', 'cui_str': 'Identification - mental defense mechanism'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0037791', 'cui_str': 'Specificity'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0205558', 'cui_str': 'False negative'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C1522495', 'cui_str': 'Sentinal Node'}, {'cui': 'C0025663', 'cui_str': 'Method'}]",400.0,0.0388999,"Compared with the final pathological results, the identification rate, sensitivity, specificity, accuracy, false negative rate, negative predictive value, positive predictive value were recorded and compared between two methods. ","[{'ForeName': 'Xiufeng', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': ""Department of Breast Surgical Oncology, Fujian Medical University Cancer Hospital and Fujian Cancer Hospital, No. 420 Fuma Road, Fuzhou, 350014, Fujian, People's Republic of China. wxf200104@hotmail.com.""}, {'ForeName': 'Lina', 'Initials': 'L', 'LastName': 'Tang', 'Affiliation': ""Department of Ultrasound, Fujian Medical University Cancer Hospital and Fujian Cancer Hospital, Fuzhou, 350014, Fujian, People's Republic of China.""}, {'ForeName': 'Weiqin', 'Initials': 'W', 'LastName': 'Huang', 'Affiliation': ""Department of Ultrasound, Fujian Medical University Cancer Hospital and Fujian Cancer Hospital, Fuzhou, 350014, Fujian, People's Republic of China.""}, {'ForeName': 'Shixin', 'Initials': 'S', 'LastName': 'Huang', 'Affiliation': ""Department of Ultrasound, Fujian Medical University Cancer Hospital and Fujian Cancer Hospital, Fuzhou, 350014, Fujian, People's Republic of China.""}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Peng', 'Affiliation': ""Department of Clinical Laboratory, Fujian Medical University Cancer Hospital and Fujian Cancer Hospital, Fuzhou, 350014, Fujian, People's Republic of China.""}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Hu', 'Affiliation': ""Department of Pathology, Fujian Medical University Cancer Hospital and Fujian Cancer Hospital, Fuzhou, 350014, Fujian, People's Republic of China.""}]",Archives of gynecology and obstetrics,['10.1007/s00404-020-05646-8'] 2409,32602065,Safety Profile of Ceftazidime-Avibactam: Pooled Data from the Adult Phase II and Phase III Clinical Trial Programme.,"INTRODUCTION Ceftazidime-avibactam combines the established anti-pseudomonal cephalosporin, ceftazidime, with the novel non-β-lactam β-lactamase inhibitor, avibactam. OBJECTIVES The aim of this study was to evaluate the safety of ceftazidime-avibactam in adults using pooled data from two phase II (NCT00690378, NCT00752219) and five phase III (NCT01499290, NCT01726023, NCT01644643, NCT01808093 and NCT01595438/NCT01599806) clinical studies. METHODS Safety data from seven multicentre, randomised, active-comparator studies were pooled by study group at the patient level for descriptive analyses, comprising patients with complicated urinary tract infection (cUTI), including pyelonephritis, complicated intra-abdominal infection (cIAI), or nosocomial pneumonia (NP), including ventilator-associated pneumonia (VAP), treated with ceftazidime-avibactam ± metronidazole or comparator. RESULTS In total, 4050 patients (ceftazidime-avibactam ± metronidazole, n = 2024; comparator, n = 2026) were included in the pooled analysis. Adverse events (AEs) up to the last study visit occurred in 996 (49.2%) and 965 (47.6%) patients treated with ceftazidime-avibactam ± metronidazole and comparator, respectively. The most common AEs across treatment groups were diarrhoea, nausea, headache, vomiting and pyrexia. There were few discontinuations due to AEs (2.5% and 1.7% for ceftazidime-avibactam ± metronidazole and comparators, respectively). Overall rates of serious AEs were 8.7% for ceftazidime-avibactam ± metronidazole and 7.2% for comparators; respective rates of AEs with an outcome of death were 2.0% and 1.8%. AEs considered causally related to the study drug or procedures occurred in 10.7% and 9.6% of patients treated with ceftazidime-avibactam ± metronidazole and comparators; the most common drug-related AEs in both groups were diarrhoea, headache, nausea and increased alanine aminotransferase. No impact to the safety profile of ceftazidime-avibactam ± metronidazole was found with regard to intrinsic factors, such as age or renal function at baseline, or extrinsic factors, such as geographical origin. Potentially clinically significant changes in laboratory parameters were infrequent with no trends or safety concerns identified. CONCLUSION The observed safety profile of ceftazidime-avibactam across infection types is consistent with the established safety profile of ceftazidime monotherapy and no new safety findings were identified. This analysis supports the use of ceftazidime-avibactam as a treatment option in adults with cUTI, cIAI and NP, including VAP.",2020,"There were few discontinuations due to AEs (2.5% and 1.7% for ceftazidime-avibactam ± metronidazole and comparators, respectively).","['adults with cUTI, cIAI and NP, including VAP', 'patients with complicated urinary tract infection (cUTI), including pyelonephritis, complicated intra-abdominal infection (cIAI), or nosocomial pneumonia (NP), including ventilator-associated pneumonia (VAP), treated with ceftazidime-avibactam\u2009±\u2009metronidazole or comparator', '4050 patients (ceftazidime-avibactam\u2009±\u2009metronidazole, n\u2009=\u20092024; comparator, n\u2009=\u20092026']","['metronidazole', 'Ceftazidime-Avibactam', 'ceftazidime-avibactam\u2009±\u2009metronidazole', 'ceftazidime-avibactam']","['Overall rates of serious AEs', 'diarrhoea, headache, nausea and increased alanine aminotransferase', 'death', 'laboratory parameters', 'Adverse events (AEs', 'diarrhoea, nausea, headache, vomiting and pyrexia']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4552431', 'cui_str': 'Complicated urinary tract infection'}, {'cui': 'C4524048', 'cui_str': 'Complicated intra-abdominal infection'}, {'cui': 'C0949083', 'cui_str': 'Hospital acquired pneumonia'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0087153', 'cui_str': 'Ventilator'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0034186', 'cui_str': 'Pyelonephritis'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C3656596', 'cui_str': 'Avibactam and ceftazidime'}, {'cui': 'C0025872', 'cui_str': 'Metronidazole'}]","[{'cui': 'C0025872', 'cui_str': 'Metronidazole'}, {'cui': 'C3656596', 'cui_str': 'Avibactam and ceftazidime'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0151905', 'cui_str': 'Alanine aminotransferase increased'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0015967', 'cui_str': 'Fever'}]",4050.0,0.0542547,"There were few discontinuations due to AEs (2.5% and 1.7% for ceftazidime-avibactam ± metronidazole and comparators, respectively).","[{'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Cheng', 'Affiliation': 'Pfizer, Sandwich, Kent, UK. karen.cheng@pfizer.com.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Newell', 'Affiliation': 'AstraZeneca, Alderley Park, Macclesfield, UK.'}, {'ForeName': 'Joseph W', 'Initials': 'JW', 'LastName': 'Chow', 'Affiliation': 'Pfizer, Collegeville, PA, USA.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Broadhurst', 'Affiliation': 'AstraZeneca, Alderley Park, Macclesfield, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Wilson', 'Affiliation': 'AstraZeneca, Alderley Park, Macclesfield, UK.'}, {'ForeName': 'Katrina', 'Initials': 'K', 'LastName': 'Yates', 'Affiliation': 'AstraZeneca, Alderley Park, Macclesfield, UK.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Wardman', 'Affiliation': 'AstraZeneca, Alderley Park, Macclesfield, UK.'}]",Drug safety,['10.1007/s40264-020-00934-3'] 2410,32602079,Randomized controlled trial of single incision versus conventional multiport laparoscopic cholecystectomy with long-term follow-up.,"BACKGROUND Within the last years, single-incision laparoscopic cholecystectomy (SLC) emerged as an alternative to multiport laparoscopic cholecystectomy (MLC). SLC has advantages in cosmetic results, and postoperative pain seems lower. Overall complications are comparable between SLC and MLC. However, long-term results of randomized trials are lacking, notably to answer questions about incisional hernia rates, long-term cosmetic impact and chronic pain. METHODS A randomized trial of SLC versus MLC with a total of 193 patients between December 2009 and June 2011 was performed. The primary endpoint was postoperative pain on the first day after surgery. Secondary endpoints were conversion rate, operative time, intraoperative and postoperative morbidity, technical feasibility and hospital stay. A long-term follow-up after surgery was added. RESULTS Ninety-eight patients (50.8%) underwent SLC, and 95 patients (49.2%) had MLC. Pain on the first postoperative day showed no difference between the operative procedures (SLC vs. MLC, 3.4 ± 1.8 vs. 3.7 ± 1.9, respectively; p = 0.317). No significant differences were observed in operating time or the overall rate of postoperative complications (4.1% vs. 3.2%; p = 0.731). SLC exhibited better cosmetic results in the short term. In the long term, after a mean of 70.4 months, there were no differences in incisional hernia rate, cosmetic results or pain at the incision between the two groups. CONCLUSIONS Taking into account a follow-up rate of 68%, the early postoperative advantages of SLC in relation to cosmetic appearance and pain did not persist in the long term. In the present trial, there was no difference in incisional hernia rates between SLC and MLC, but the sample size is too small for a final conclusion regarding hernia rates. TRIAL REGISTRATION German Registry of Clinical Trials DRKS00012447.",2020,"In the long term, after a mean of 70.4 months, there were no differences in incisional hernia rate, cosmetic results or pain at the incision between the two groups. ",['193 patients between December 2009 and June 2011 was performed'],"['single incision versus conventional multiport laparoscopic cholecystectomy', 'MLC', 'multiport laparoscopic cholecystectomy (MLC', 'SLC', 'incision laparoscopic cholecystectomy (SLC']","['cosmetic appearance and pain', 'incisional hernia rates', 'postoperative pain', 'Pain', 'MLC', 'conversion rate, operative time, intraoperative and postoperative morbidity, technical feasibility and hospital stay', 'Overall complications', 'incisional hernia rate, cosmetic results or pain', 'operating time or the overall rate of postoperative complications']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0884358', 'cui_str': 'Performed'}]","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0162522', 'cui_str': 'Laparoscopic cholecystectomy'}]","[{'cui': 'C0010164', 'cui_str': 'Cosmetic'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0267716', 'cui_str': 'Incisional hernia'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0162522', 'cui_str': 'Laparoscopic cholecystectomy'}, {'cui': 'C0439836', 'cui_str': 'Conversions'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0449851', 'cui_str': 'Technique'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}]",193.0,0.191944,"In the long term, after a mean of 70.4 months, there were no differences in incisional hernia rate, cosmetic results or pain at the incision between the two groups. ","[{'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Klein', 'Affiliation': 'Department of Surgery, Charité Campus Mitte, Campus Virchow Klinikum, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Charitéplatz 1, 10117, Berlin, Germany.'}, {'ForeName': 'Atakan Görkem', 'Initials': 'AG', 'LastName': 'Barutcu', 'Affiliation': 'Department of Surgery, Charité Campus Mitte, Campus Virchow Klinikum, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Charitéplatz 1, 10117, Berlin, Germany.'}, {'ForeName': 'Dino', 'Initials': 'D', 'LastName': 'Kröll', 'Affiliation': 'Department of Surgery, Charité Campus Mitte, Campus Virchow Klinikum, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Charitéplatz 1, 10117, Berlin, Germany.'}, {'ForeName': 'Maik', 'Initials': 'M', 'LastName': 'Kilian', 'Affiliation': 'Department of Surgery, Charité Campus Mitte, Campus Virchow Klinikum, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Charitéplatz 1, 10117, Berlin, Germany.'}, {'ForeName': 'Johann', 'Initials': 'J', 'LastName': 'Pratschke', 'Affiliation': 'Department of Surgery, Charité Campus Mitte, Campus Virchow Klinikum, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Charitéplatz 1, 10117, Berlin, Germany.'}, {'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Raakow', 'Affiliation': 'Department of General, Visceral and Vascular Surgery, Vivantes Klinikum Am Urban, Dieffenbachstrasse 1, 10967, Berlin, Germany.'}, {'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'Raakow', 'Affiliation': 'Department of Surgery, Charité Campus Mitte, Campus Virchow Klinikum, Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Charitéplatz 1, 10117, Berlin, Germany. jonas.raakow@charite.de.'}]",Langenbeck's archives of surgery,['10.1007/s00423-020-01911-1'] 2411,31389889,"Does Robotic-assisted TKA Result in Better Outcome Scores or Long-Term Survivorship Than Conventional TKA? A Randomized, Controlled Trial.","BACKGROUND Robotic-assisted TKA was introduced to enhance the precision of bone preparation and component alignment with the goal of improving the clinical results and survivorship of TKA. Although numerous reports suggest that bone preparation and knee component alignment may be improved using robotic assistance, no long-term randomized trials of robotic-assisted TKA have shown whether this results in improved clinical function or survivorship of the TKA. QUESTIONS/PURPOSES In this randomized trial, we compared robotic-assisted TKA to manual-alignment techniques at long-term follow-up in terms of (1) functional results based on Knee Society, WOMAC, and UCLA Activity scores; (2) numerous radiographic parameters, including component and limb alignment; (3) Kaplan-Meier survivorship; and (4) complications specific to robotic-assistance, including pin-tract infection, peroneal nerve palsy, pin-site fracture, or patellar complications. METHODS This study was a registered prospective, randomized, controlled trial. From January 2002 to February 2008, one surgeon performed 975 robotic-assisted TKAs in 850 patients and 990 conventional TKAs in 849 patients. Among these patients 1406 patients were eligible for participation in this study based on prespecified inclusion criteria. Of those, 100% (1406) patients agreed to participate and were randomized, with 700 patients (750 knees) receiving robotic-assisted TKA and 706 patients (766 knees) receiving conventional TKA. Of those, 96% (674 patients) in the robotic-assisted TKA group and 95% (674 patients) in the conventional TKA group were available for follow-up at a mean of 13 (± 5) years. In both groups, no patient older than 65 years was randomized because we anticipated long-term follow-up. We evaluated 674 patients (724 knees) in each group for clinical and radiographic outcomes, and we examined Kaplan-Meier survivorship for the endpoint of aseptic loosening or revision. Clinical evaluation was performed using the original Knee Society knee score, the WOMAC score, and the UCLA activity score preoperatively and at latest follow-up visit. We also assessed loosening (defined as change in the position of the components) using plain radiographs, osteolysis using CT scans at the latest follow-up visit, and component, and limb alignment on mechanical axis radiographs.To minimize the chance of type-2 error and increase the power of our study, we assumed the difference in the Knee Society score to be 5 points to match the MCID of the Knee Society with power of 0.99, which revealed that a total of 628 patients would be needed in each group. RESULTS Clinical parameters at the latest follow-up including the Knee Society knee scores (93 ± 5 points in the robotic-assisted TKA group versus 92 ± 6 points in the conventional TKA group [95% confidence interval 90 to 98]; p = 0.321) and Knee Society knee function scores (83 ± 7 points in the robotic-assisted TKA group versus 85 ± 6 points in the conventional TKA group [95% CI 75 to 88]; p = 0.992), WOMAC scores (18 ± 14 points in the robotic-assisted TKA group versus 19 ± 15 points in the conventional TKA group [95% CI 16 to 22]; p = 0.981), range of knee motion (125 ± 6° in the robotic-assisted TKA group versus 128 ± 7° in the conventional TKA group [95% CI 121 to 135]; p = 0.321), and UCLA patient activity scores (7 points versus 7 points in each group [95% CI 5 to 10]; p = 1.000) were not different between the two groups at a mean of 13 years' follow-up. Radiographic parameters such as the femorotibial angle (mean 2° ± 2° valgus in the robotic-assisted TKA group versus 3° ± 3° valgus in the conventional TKA group [95% CI 1 to 5]; p = 0.897), femoral component position (coronal plane: mean 98° in the robotic-assisted TKA group versus 97° in the conventional TKA group [95% CI 96 to 99]; p = 0.953; sagittal plane: mean 3° in the robotic-assisted TKA group versus 2° in the conventional TKA group [95% CI 1 to 4]; p = 0.612) and tibial component position (coronal plane: mean 90° in the robotic-assisted TKA group versus 89° in the conventional TKA group [95% CI 87 to 92]; p = 0.721; sagittal plane: 87° in the robotic-assisted TKA group versus 86° in the conventional TKA group [95% CI 84 to 89]; p = 0.792), joint line (16 mm in the robotic-assisted TKA group versus 16 mm in the conventional TKA group [95% CI 14 to 18]; p = 0.512), and posterior femoral condylar offset (24 mm in the robotic-assisted TKA group versus 24 mm in the conventional TKA group [95% CI 21 to 27 ]; p = 0.817) also were not different between the two groups (p > 0.05). The aseptic loosening rate was 2% in each group, and this was not different between the two groups. With the endpoint of revision or aseptic loosening of the components, Kaplan-Meier survivorship of the TKA components was 98% in both groups (95% CI 94 to 100) at 15 years (p = 0.972). There were no between-group differences in terms of the frequency with which complications occurred. In each group, 2% of knees (15) had a superficial infection treated with intravenous antibiotics for 2 weeks. No deep infection occurred in these knees. In the conventional TKA group, 0.8% of knees (six) had a motion limitation (< 60°). CONCLUSIONS At a minimum follow-up of 10 years, we found no differences between robotic-assisted TKA and conventional TKA in terms of functional outcome scores, aseptic loosening, overall survivorship, and complications. Considering the additional time and expense associated with robotic-assisted TKA, we cannot recommend its widespread use. LEVEL OF EVIDENCE Level I, therapeutic study.",2020,"At a minimum follow-up of 10 years, we found no differences between robotic-assisted TKA and conventional TKA in terms of functional outcome scores, aseptic loosening, overall survivorship, and complications.","['Of those, 100% (1406) patients agreed to participate and were randomized, with 700 patients (750 knees) receiving', 'and 706 patients (766 knees) receiving', 'in 850 patients and 990 conventional TKAs in 849 patients', 'patients 1406 patients were eligible for participation in this study based on prespecified inclusion criteria', '674 patients (724 knees) in each group for clinical and radiographic outcomes, and we examined Kaplan-Meier survivorship for the endpoint of aseptic loosening or revision']","['conventional TKA', 'tibial component position (coronal plane: mean', 'intravenous antibiotics', '975 robotic-assisted TKAs', 'Robotic-assisted TKA', 'robotic-assisted TKA']","['posterior femoral condylar offset', 'revision or aseptic loosening of the components, Kaplan-Meier survivorship of the TKA components', 'original Knee Society knee score, the WOMAC score, and the UCLA activity score', 'UCLA patient activity scores', 'aseptic loosening rate', 'Knee Society, WOMAC, and UCLA Activity scores; (2) numerous radiographic parameters, including component and limb alignment; (3) Kaplan-Meier survivorship; and (4) complications specific to robotic-assistance, including pin-tract infection, peroneal nerve palsy, pin-site fracture, or patellar complications', 'WOMAC scores', 'femoral component position', 'Knee Society knee scores', 'range of knee motion', 'Knee Society knee function scores', 'functional outcome scores, aseptic loosening, overall survivorship, and complications', 'deep infection']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517862', 'cui_str': '700'}, {'cui': 'C4517868', 'cui_str': '750'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C3840657', 'cui_str': '850'}, {'cui': 'C4517916', 'cui_str': '990'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0333050', 'cui_str': 'Loosening'}, {'cui': 'C0439616', 'cui_str': 'Revisions'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0040184', 'cui_str': 'Bone structure of tibia'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C4551585', 'cui_str': 'Coronal plane'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C4517911', 'cui_str': '975'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}]","[{'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}, {'cui': 'C0439616', 'cui_str': 'Revisions'}, {'cui': 'C0232920', 'cui_str': 'Sterile'}, {'cui': 'C0333050', 'cui_str': 'Loosening'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205313', 'cui_str': 'Original'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0021885', 'cui_str': 'Bone nailing'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0270810', 'cui_str': 'Peroneal nerve palsy'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0030647', 'cui_str': 'Bone structure of patella'}, {'cui': 'C0449434', 'cui_str': 'Femoral component'}, {'cui': 'C0733755', 'cui_str': 'Position'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0026597', 'cui_str': 'Motion'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205125', 'cui_str': 'Deep'}]",1406.0,0.114253,"At a minimum follow-up of 10 years, we found no differences between robotic-assisted TKA and conventional TKA in terms of functional outcome scores, aseptic loosening, overall survivorship, and complications.","[{'ForeName': 'Young-Hoo', 'Initials': 'YH', 'LastName': 'Kim', 'Affiliation': 'Y.-H. Kim, The Joint Replacement Center, Seoul Metropolitan SeoNam Hospital, Seoul, Republic of Korea S.-H. Yoon, The Joint Replacement Center, Lee Chun Teck Hospital, Suwon, Seoul, Republic of Korea J.-W. Park, The Joint Replacement Center, Ewha Womans University Ewha Seoul Hospital, Seoul, Republic of Korea.'}, {'ForeName': 'Sung-Hwan', 'Initials': 'SH', 'LastName': 'Yoon', 'Affiliation': ''}, {'ForeName': 'Jang-Won', 'Initials': 'JW', 'LastName': 'Park', 'Affiliation': ''}]",Clinical orthopaedics and related research,['10.1097/CORR.0000000000000916'] 2412,31402323,Ibrutinib and rituximab for chronic lymphocytic leukaemia.,,2019,,['chronic lymphocytic leukaemia'],['Ibrutinib and rituximab'],[],"[{'cui': 'C0023434', 'cui_str': 'Chronic lymphocytic leukemia'}]","[{'cui': 'C3501358', 'cui_str': 'Ibrutinib'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}]",[],,0.0205762,,"[{'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Stirrups', 'Affiliation': ''}]",The Lancet. Oncology,['10.1016/S1470-2045(19)30528-5'] 2413,32602233,Increased dairy product consumption as part of a diet and exercise weight management program improves body composition in adolescent females with overweight and obesity-A randomized controlled trial.,"BACKGROUND Exercise can improve body composition in adolescents and adults with overweight/obesity. Consumption of dairy foods, as part of a healthy lifestyle program, can also promote favourable body composition changes in adults with overweight/obesity. However, the few studies examining these combined effects on body composition in adolescents are inconclusive. OBJECTIVE To determine whether increased dairy product consumption, as part of a lifestyle modification program featuring exercise training and dietary guidance promotes favourable body composition changes in adolescent females with overweight/obesity. METHODS Fifty-four participants (age: 14.8 ± 2.2y; BMI percentile: 95th ± 6) assigned to three groups completed the study. There were two experimental groups: recommended dairy (RDa; n = 24) and low dairy (LDa; n = 22), and a no-intervention control group (Con; n = 8). RDa and LDa participated in a 12-week, eucaloric, lifestyle modification intervention consisting of mixed-mode exercise (3x/week), and nutritional counselling. RDa was provided 4 servings/day of dairy foods, while LDa and Con maintained habitually low intakes (0-2 servings/day). Body weight/composition, waist/hip circumference, cardiovascular fitness and food intake were assessed at weeks 0 and 12. RESULTS Weight did not significantly change in any group. RDa significantly decreased fat mass (FM) and increased lean mass (LM) more than LDa and Con (FM: -1.3 ± 2.1 kg, -1.1 ± 2.0 kg, 0.8 ± 1.8 kg; LM: 1.5 ± 1.9 kg, 0.7 ± 1.6 kg, 0.5 ± 1.4 kg, respectively). LDa also significantly decreased FM and increased LM more than Con (P < .005; all interactions). CONCLUSION The inclusion of dairy foods in the diet of adolescent females with overweight/obesity, as part of a diet and exercise intervention, favourably improves body composition in the absence of weight loss.",2020,"RDa significantly decreased fat mass (FM) and increased lean mass (LM) more than LDa and Con (FM: -1.3 ± 2.1 kg, -1.1 ± 2.0 kg, 0.8 ± 1.8 kg; LM: 1.5 ± 1.9 kg, 0.7 ± 1.6 kg, 0.5 ± 1.4 kg, respectively).","['dairy (RDa; n = 24) and low dairy (LDa; n = 22), and a no-intervention control group (Con; n = 8). RDa and LDa participated in a 12-week', 'adolescents and adults with overweight/obesity', 'adolescent females with overweight and obesity', 'adolescent females with overweight/obesity', 'adults with overweight/obesity', 'Fifty-four participants (age: 14.8\u2009±\u20092.2y; BMI percentile: 95th\u2009±\u20096) assigned to three groups completed the study']","['exercise weight management program', 'Exercise', 'eucaloric, lifestyle modification intervention consisting of mixed-mode exercise (3x/week), and nutritional counselling']","['LDa', 'body composition', 'fat mass (FM) and increased lean mass (LM', 'Weight', 'Body weight/composition, waist/hip circumference, cardiovascular fitness and food intake', 'FM and increased LM']","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0620347', 'cui_str': 'compound A 12'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0001588', 'cui_str': 'Adolescents, Female'}, {'cui': 'C4517807', 'cui_str': '54'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1264641', 'cui_str': 'Percentile'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C4273558', 'cui_str': 'Weight management program'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}, {'cui': 'C0230097', 'cui_str': 'Structure of waist (surface region)'}, {'cui': 'C0562350', 'cui_str': 'Hip circumference'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0013470', 'cui_str': 'Eating'}]",54.0,0.0204285,"RDa significantly decreased fat mass (FM) and increased lean mass (LM) more than LDa and Con (FM: -1.3 ± 2.1 kg, -1.1 ± 2.0 kg, 0.8 ± 1.8 kg; LM: 1.5 ± 1.9 kg, 0.7 ± 1.6 kg, 0.5 ± 1.4 kg, respectively).","[{'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Calleja', 'Affiliation': 'Department of Kinesiology, Faculty of Applied Health Sciences, Brock University, St. Catharines, Canada.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Caetano Feitoza', 'Affiliation': 'Department of Kinesiology, Faculty of Applied Health Sciences, Brock University, St. Catharines, Canada.'}, {'ForeName': 'Bareket', 'Initials': 'B', 'LastName': 'Falk', 'Affiliation': 'Department of Kinesiology, Faculty of Applied Health Sciences, Brock University, St. Catharines, Canada.'}, {'ForeName': 'Panagiota', 'Initials': 'P', 'LastName': 'Klentrou', 'Affiliation': 'Department of Kinesiology, Faculty of Applied Health Sciences, Brock University, St. Catharines, Canada.'}, {'ForeName': 'Wendy E', 'Initials': 'WE', 'LastName': 'Ward', 'Affiliation': 'Department of Kinesiology, Faculty of Applied Health Sciences, Brock University, St. Catharines, Canada.'}, {'ForeName': 'Philip J', 'Initials': 'PJ', 'LastName': 'Sullivan', 'Affiliation': 'Department of Kinesiology, Faculty of Applied Health Sciences, Brock University, St. Catharines, Canada.'}, {'ForeName': 'Andrea R', 'Initials': 'AR', 'LastName': 'Josse', 'Affiliation': 'Centre for Bone and Muscle Health, Faculty of Applied Health Sciences, Brock University, St. Catharines, Canada.'}]",Pediatric obesity,['10.1111/ijpo.12690'] 2414,32602273,"Effect of Dapagliflozin as an Add-on Therapy to Insulin on the Glycemic Variability in Subjects with Type 2 Diabetes Mellitus (DIVE): A Multicenter, Placebo-Controlled, Double-Blind, Randomized Study.","BACKGROUND Glycemic variability is associated with the development of diabetic complications and hypoglycemia. However, the effect of sodium-glucose transporter 2 (SGLT2) inhibitors on glycemic variability is controversial. We aimed to examine the effect of dapagliflozin as an add-on therapy to insulin on the glycemic variability assessed using continuous glucose monitoring (CGM) in subjects with type 2 diabetes mellitus. METHODS In this multicenter, placebo-controlled, double-blind, randomized study, 84 subjects received 10 mg of dapagliflozin ( n =41) or the placebo ( n =43) for 12 weeks. CGM was performed before and after treatment to compare the changes in glycemic variability measures (standard deviation [SD], mean amplitude of glycemic excursions [MAGEs]). RESULTS At week 12, significant reductions in glycosylated hemoglobin (-0.74%±0.66% vs. 0.01%±0.65%, P <0.001), glycated albumin (-3.94%±2.55% vs. -0.67%±2.48%, P <0.001), and CGM-derived mean glucose (-41.6±39.2 mg/dL vs. 1.1±46.2 mg/dL, P <0.001) levels were observed in the dapagliflozin group compared with the placebo group. SD and MAGE were significantly decreased in the dapagliflozin group, but not in the placebo group. However, the difference in ΔSD and ΔMAGE failed to reach statistical significance between two groups. No significant differences in the incidence of safety endpoints were observed between the two groups. CONCLUSION Dapagliflozin effectively decreased glucose levels, but not glucose variability, after 12 weeks of treatment in participants with type 2 diabetes mellitus receiving insulin treatment. The role of SGLT2 inhibitors in glycemic variability warrants further investigations.",2020,"At week 12, significant reductions in glycosylated hemoglobin (-0.74%±0.66% vs. 0.01%±0.65%, P <0.001), glycated albumin (-3.94%±2.55% vs. -0.67%±2.48%, P <0.001), and CGM-derived mean glucose (-41.6±39.2 mg/dL vs. 1.1±46.2 mg/dL, P <0.001) levels were observed in the dapagliflozin group compared with the placebo group.","['84 subjects received 10 mg of', 'subjects with type 2 diabetes mellitus', 'participants with type 2 diabetes mellitus receiving insulin treatment', 'Subjects with Type 2 Diabetes Mellitus (DIVE']","['continuous glucose monitoring (CGM', 'Placebo', 'dapagliflozin', 'SGLT2 inhibitors', 'sodium-glucose transporter 2 (SGLT2) inhibitors', 'CGM', 'Dapagliflozin', 'placebo']","['glycated albumin', 'CGM-derived mean glucose', 'glucose levels', 'Glycemic Variability', 'SD and MAGE', 'incidence of safety endpoints', 'glycosylated hemoglobin', 'glycemic variability measures (standard deviation [SD], mean amplitude of glycemic excursions [MAGEs']","[{'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0012823', 'cui_str': 'Diving'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C3273807', 'cui_str': 'SGLT2 Inhibitors'}, {'cui': 'C1565154', 'cui_str': 'SGLT2 Protein'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}]",84.0,0.277763,"At week 12, significant reductions in glycosylated hemoglobin (-0.74%±0.66% vs. 0.01%±0.65%, P <0.001), glycated albumin (-3.94%±2.55% vs. -0.67%±2.48%, P <0.001), and CGM-derived mean glucose (-41.6±39.2 mg/dL vs. 1.1±46.2 mg/dL, P <0.001) levels were observed in the dapagliflozin group compared with the placebo group.","[{'ForeName': 'Seung Hwan', 'Initials': 'SH', 'LastName': 'Lee', 'Affiliation': ""Division of Endocrinology and Metabolism, Department of Internal Medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea.""}, {'ForeName': 'Kyung Wan', 'Initials': 'KW', 'LastName': 'Min', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Internal Medicine, Eulji General Hospital, Eulji University School of Medicine, Seoul, Korea.'}, {'ForeName': 'Byung Wan', 'Initials': 'BW', 'LastName': 'Lee', 'Affiliation': 'Division of Endocrinology and Metabolism, Department of Internal Medicine, Yonsei University College of Medicine, Seoul, Korea.'}, {'ForeName': 'In Kyung', 'Initials': 'IK', 'LastName': 'Jeong', 'Affiliation': 'Department of Endocrinology and Metabolism, Kyung Hee University Hospital at Gangdong, Kyung Hee University School of Medicine, Seoul, Korea.'}, {'ForeName': 'Soon Jib', 'Initials': 'SJ', 'LastName': 'Yoo', 'Affiliation': ""Division of Endocrinology and Metabolism, Department of Internal Medicine, Bucheon St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Bucheon, Korea.""}, {'ForeName': 'Hyuk Sang', 'Initials': 'HS', 'LastName': 'Kwon', 'Affiliation': ""Division of Endocrinology and Metabolism, Department of Internal Medicine, Uijeongbu St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea.""}, {'ForeName': 'Yoon Hee', 'Initials': 'YH', 'LastName': 'Choi', 'Affiliation': ""Division of Endocrinology and Metabolism, Department of Internal Medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea.""}, {'ForeName': 'Kun Ho', 'Initials': 'KH', 'LastName': 'Yoon', 'Affiliation': ""Division of Endocrinology and Metabolism, Department of Internal Medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea.""}]",Diabetes & metabolism journal,['10.4093/dmj.2019.0203'] 2415,32602301,Endovascular or open surgical treatment of high-risk patients with infrainguinal peripheral arterial disease and critical limb ischemia.,"Aim To determine preferable type of treatment in our clinical circumstances by following two groups of patients with critical limb ischemia (CLI), who were treated endovascularly and surgically. Methods Research was carried out in the form of a prospective study of 80 patients with CLI and Trans-Atlantic Inter-Society Consensus (TASC) C or D type of arterial disease, with American Society of Anesthesiology (ASA) class III risk, who were randomly divided in two groups as per the treatment they received, surgical and endovascular. Patients were followed during 28 months using clinical examination and Duplex Ultrasound (DUS) in accordance with prescheduled control visits. Results There was a statistical difference between surgical and endovascular group in two years patency (82.5% vs. 55%; p=0.022) but it did not result in the difference in amputation free survival (AFS) (95% vs. 85%; p=0.171) or two-year freedom from major adverse limb events (MALE) (87.5 vs. 77.5; p=0.254). Also, there was no difference in the overall survival of patients (100% vs. 97.5%; p=0.317). Conclusion Initial endovascular treatment is a preferred form of the treatment for selected patient population.",2020,There was a statistical difference between surgical and endovascular group in two years patency (82.5% vs. 55%; p=0.022) but it did not result in the difference in amputation free survival (AFS) (95% vs. 85%; p=0.171) or two-year freedom from major adverse limb events (MALE) (87.5 vs. 77.5; p=0.254).,"['80 patients with CLI and Trans-Atlantic Inter-Society Consensus (TASC) C or D type of arterial disease, with American Society of Anesthesiology (ASA) class III risk', 'patients with critical limb ischemia (CLI), who were treated endovascularly and surgically', 'selected patient population', 'high-risk patients with infrainguinal peripheral arterial disease and critical limb ischemia']","['Endovascular or open surgical treatment', 'surgical and endovascular']","['amputation free survival (AFS', 'overall survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1142264', 'cui_str': 'Critical limb ischemia'}, {'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0376298', 'cui_str': 'Consensus'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0852949', 'cui_str': 'Disorder of artery'}, {'cui': 'C0002930', 'cui_str': 'Anesthetics'}, {'cui': 'C0441887', 'cui_str': 'Class 3'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0085096', 'cui_str': 'Peripheral vascular disease'}]","[{'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}]","[{'cui': 'C0002688', 'cui_str': 'Amputation'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",80.0,0.0316282,There was a statistical difference between surgical and endovascular group in two years patency (82.5% vs. 55%; p=0.022) but it did not result in the difference in amputation free survival (AFS) (95% vs. 85%; p=0.171) or two-year freedom from major adverse limb events (MALE) (87.5 vs. 77.5; p=0.254).,"[{'ForeName': 'Dragan', 'Initials': 'D', 'LastName': 'Totić', 'Affiliation': 'Clinic for Cardiovascular Surgery, University Clinical Centre, Sarajevo, Bosnia and Herzegovina.'}, {'ForeName': 'Vesna', 'Initials': 'V', 'LastName': 'Ðurović Sarajlić', 'Affiliation': 'Clinic for Cardiovascular Surgery, University Clinical Centre, Sarajevo, Bosnia and Herzegovina.'}, {'ForeName': 'Haris', 'Initials': 'H', 'LastName': 'Vranić', 'Affiliation': 'Clinic for Cardiovascular Surgery, University Clinical Centre, Sarajevo, Bosnia and Herzegovina.'}, {'ForeName': 'Amel', 'Initials': 'A', 'LastName': 'Hadžimehmedagić', 'Affiliation': 'Clinic for Cardiovascular Surgery, University Clinical Centre, Sarajevo, Bosnia and Herzegovina.'}, {'ForeName': 'Nedžad', 'Initials': 'N', 'LastName': 'Rustempašić', 'Affiliation': 'Clinic for Cardiovascular Surgery, University Clinical Centre, Sarajevo, Bosnia and Herzegovina.'}, {'ForeName': 'Muhamed', 'Initials': 'M', 'LastName': 'Djedović', 'Affiliation': 'Clinic for Cardiovascular Surgery, University Clinical Centre, Sarajevo, Bosnia and Herzegovina.'}, {'ForeName': 'Haris', 'Initials': 'H', 'LastName': 'Vukas', 'Affiliation': 'Department of Surgery, Cantonal Hospital, Zenica, Bosnia and Herzegovina.'}, {'ForeName': 'Alen', 'Initials': 'A', 'LastName': 'Ahmetašević', 'Affiliation': 'Clinic for Cardiovascular Surgery, University Clinical Centre, Sarajevo, Bosnia and Herzegovina.'}]","Medicinski glasnik : official publication of the Medical Association of Zenica-Doboj Canton, Bosnia and Herzegovina",['10.17392/1143-20'] 2416,32605578,"The efficacy of Bifidobacterium quadruple viable tablet in the treatment of diarrhea predominant irritable bowel syndrome: protocol for a randomized, double-blind, placebo-controlled, multicenter trial.","BACKGROUND Irritable bowel syndrome (IBS) is one of the most common functional gastrointestinal disorders characterized by recurrent abdominal pain associated with defecation or a change in bowel habits. Leading to significant negative effect on patients' quality of life and huge financial burden to health system, the management of IBS is a great challenge. Probiotics are considered as an effective therapy; however, in a lack of high-quality evidence of efficacy, no strain- and dose-specific probiotics were recommended in clinical guidelines. This study aims to evaluate the efficacy of the Bifidobacterium quadruple viable tablet in the treatment of IBS-D. METHODS/DESIGN A multicenter randomized controlled trial will be performed in fourteen hospitals. A total of three hundred patients who fulfill the eligibility criteria will be stratified divided into an experimental group and a control group randomly in a ratio of 1:1. The experimental group is treated with the Bifidobacterium quadruple viable tablet while the control group is treated with placebo. All the patients will receive a 4-week treatment and a 2-week follow-up. The primary outcome is the effectiveness in improving abdominal pain and stool consistency; the secondary outcome includes evaluation of overall symptom relief, frequency of defecation, bloating, urgency of defecation, remedial medication, score of IBS-QOL, and changes of microbiota and metabonomics. Physical examination, vital signs, laboratory tests, adverse events, and concomitant medication will be taken into account for intervention safety assessment during the trial. DISCUSSION This multicenter randomized controlled trial may provide high-quality evidence on the efficacy of the Bifidobacterium quadruple viable tablet for IBS-D on both physical and mental dimensions in China. To fill the gap of previous probiotic intervention studies, in addition, this study will also present safety assessment which will be a significant emphasis. TRIAL REGISTRATION ChiCTR1800017721 . Registered on 10 August 2018.",2020,"Leading to significant negative effect on patients' quality of life and huge financial burden to health system, the management of IBS is a great challenge.","['fourteen hospitals', 'diarrhea predominant irritable bowel syndrome', 'China', 'A total of three hundred patients who fulfill the eligibility criteria']","['Bifidobacterium quadruple viable tablet', 'placebo']","['effectiveness in improving abdominal pain and stool consistency; the secondary outcome includes evaluation of overall symptom relief, frequency of defecation, bloating, urgency of defecation, remedial medication, score of IBS-QOL, and changes of microbiota and metabonomics', 'Physical examination, vital signs, laboratory tests, adverse events']","[{'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C1262211', 'cui_str': 'Diarrhoea predominant irritable bowel syndrome'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0005380', 'cui_str': 'Bifidobacterium'}, {'cui': 'C0205175', 'cui_str': 'Quadruple'}, {'cui': 'C0443348', 'cui_str': 'Viable'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0000737', 'cui_str': 'Abdominal pain'}, {'cui': 'C0426740', 'cui_str': 'Consistency of stool'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0564405', 'cui_str': 'Feeling relief'}, {'cui': 'C0581872', 'cui_str': 'Frequency of defecation'}, {'cui': 'C0439609', 'cui_str': 'Urgent'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0022104', 'cui_str': 'Irritable bowel syndrome'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C3887843', 'cui_str': 'Microbial Community'}, {'cui': 'C1956136', 'cui_str': 'Metabonomics'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0022885', 'cui_str': 'Laboratory procedure'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",300.0,0.190122,"Leading to significant negative effect on patients' quality of life and huge financial burden to health system, the management of IBS is a great challenge.","[{'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Bai', 'Affiliation': 'Division of Gastroenterology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, 1277 Jiefang Avenue, Wuhan, Hubei, China.'}, {'ForeName': 'Haoyu', 'Initials': 'H', 'LastName': 'Zeng', 'Affiliation': 'Division of Gastroenterology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, 1277 Jiefang Avenue, Wuhan, Hubei, China.'}, {'ForeName': 'Yanqin', 'Initials': 'Y', 'LastName': 'Long', 'Affiliation': 'Division of Gastroenterology, Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, 3 East Qingchun Road, Hangzhou, Zhejiang, China.'}, {'ForeName': 'Xiaoqing', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Division of Gastroenterology, Peking Union Medical College Hospital, No. 1 Shuaifuyuan Wangfujing Dongcheng District, Beijing, China.'}, {'ForeName': 'Xiaohong', 'Initials': 'X', 'LastName': 'Sun', 'Affiliation': 'Division of Gastroenterology, Peking Union Medical College Hospital, No. 1 Shuaifuyuan Wangfujing Dongcheng District, Beijing, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Lan', 'Affiliation': 'Division of Gastroenterology, Beijing Jishuitan Hospital, Xicheng District Xinjiekou No. 31 East Street, Beijing, China.'}, {'ForeName': 'Lingling', 'Initials': 'L', 'LastName': 'Gao', 'Affiliation': 'Peking University Clinical Research Institute, No.38 Xueyuan Road, Haidian District, Beijing, China.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Hangzhou Grand Biologic Pharmaceutical. INC, 63 Jiuhuan Road, Jianggan District, Hangzhou, Zhejiang, China.'}, {'ForeName': 'Zenghui', 'Initials': 'Z', 'LastName': 'Feng', 'Affiliation': 'Hangzhou Grand Biologic Pharmaceutical. INC, 63 Jiuhuan Road, Jianggan District, Hangzhou, Zhejiang, China.'}, {'ForeName': 'Xiaohua', 'Initials': 'X', 'LastName': 'Hou', 'Affiliation': 'Division of Gastroenterology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, 1277 Jiefang Avenue, Wuhan, Hubei, China. houxh@hust.edu.cn.'}]",Trials,['10.1186/s13063-020-04490-0'] 2417,32605585,Effectiveness and cost-effectiveness of a community-based mental health care programme (GBV) for people with severe mental illness in Germany: study protocol for a randomised controlled trial.,"BACKGROUND The community-based mental health care programme GBV is based on the British Community Mental Health Teams and the Dutch Flexible Assertive Community Treatment model. In addition, the programme offers crisis-intervention services. A special feature of this integrated care programme is the initial standardised assessment process regarding empowerment, unmet care needs, and psychosocial functioning, used to verify the need for such a comprehensive form of care. The project evaluates the assessment process and analyses the effectiveness and cost-effectiveness of GBV compared to treatment as usual. METHODS This randomised, controlled study includes five assessments over 2 years. In twelve regions in Germany, 1000 patients with severely impaired psychosocial functioning and unmet care needs will be recruited. Study eligibility relies on an indication for GBV based on the results of the initial assessment. The primary outcome is improved self-reported empowerment. Further outcomes include improved treatment satisfaction and subjective quality of life, reductions in patients' unmet needs and illness-related clinical and social impairment, and an improved cost-effectiveness ratio of the resources used (from the perspectives of both statutory health insurance and the national economy). In addition, the GBV's effects on the burden and quality of life of informal caregivers of patients will be investigated. DISCUSSION The study's results are expected to provide information on whether the community-based mental health care programme GBV contributes to improving mental health care provision in Germany. In addition, the study will show whether the GBV successfully overcomes the weaknesses that former research has identified regarding a German integrated care programme. Such improvement is particularly expected with respect to the semi-structured assessment within GBV. TRIAL REGISTRATION German Clinical Trial Register, DRKS00019086 . Registered on 3 January 2020.",2020,"Further outcomes include improved treatment satisfaction and subjective quality of life, reductions in patients' unmet needs and illness-related clinical and social impairment, and an improved cost-effectiveness ratio of the resources used (from the perspectives of both statutory health insurance and the national economy).","['1000 patients with severely impaired psychosocial functioning and unmet care needs will be recruited', 'people with severe mental illness in Germany', 'Germany']","['community-based mental health care programme (GBV', 'GBV']","['burden and quality of life of informal caregivers', 'self-reported empowerment', ""treatment satisfaction and subjective quality of life, reductions in patients' unmet needs and illness-related clinical and social impairment, and an improved cost-effectiveness ratio of the resources used (from the perspectives of both statutory health insurance and the national economy"", 'Effectiveness and cost-effectiveness']","[{'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}, {'cui': 'C0017480', 'cui_str': 'Germany'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184643', 'cui_str': 'Mental health care'}, {'cui': 'C0376574', 'cui_str': 'Hepatitis G virus'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1319882', 'cui_str': 'Informal caregiver'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0679959', 'cui_str': 'Empowerment'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0027452', 'cui_str': 'National Health Insurance'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",1000.0,0.0975862,"Further outcomes include improved treatment satisfaction and subjective quality of life, reductions in patients' unmet needs and illness-related clinical and social impairment, and an improved cost-effectiveness ratio of the resources used (from the perspectives of both statutory health insurance and the national economy).","[{'ForeName': 'Annabel Sandra', 'Initials': 'AS', 'LastName': 'Mueller-Stierlin', 'Affiliation': 'Department of Psychiatry II, Ulm University, Bezirkskrankenhaus Günzburg, Günzburg, Germany. Annabel.Mueller-Stierlin@uni-ulm.de.'}, {'ForeName': 'Friedrich', 'Initials': 'F', 'LastName': 'Meixner', 'Affiliation': 'Department of Psychiatry II, Ulm University, Bezirkskrankenhaus Günzburg, Günzburg, Germany.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Kohlmann', 'Affiliation': 'Department of Psychiatry II, Ulm University, Bezirkskrankenhaus Günzburg, Günzburg, Germany.'}, {'ForeName': 'Mara', 'Initials': 'M', 'LastName': 'Schumacher', 'Affiliation': 'Department of Psychiatry II, Ulm University, Bezirkskrankenhaus Günzburg, Günzburg, Germany.'}, {'ForeName': 'Anke', 'Initials': 'A', 'LastName': 'Hänsel', 'Affiliation': 'Department of Psychiatry II, Ulm University, Bezirkskrankenhaus Günzburg, Günzburg, Germany.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Pouwels', 'Affiliation': 'Department of Psychiatry II, Ulm University, Bezirkskrankenhaus Günzburg, Günzburg, Germany.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Bias', 'Affiliation': 'Department of Psychiatry II, Ulm University, Bezirkskrankenhaus Günzburg, Günzburg, Germany.'}, {'ForeName': 'Sabrina', 'Initials': 'S', 'LastName': 'Hartl', 'Affiliation': 'Department of Psychiatry II, Ulm University, Bezirkskrankenhaus Günzburg, Günzburg, Germany.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Reichstein', 'Affiliation': 'Dachverband Gemeindepsychiatrie, Cologne, Germany.'}, {'ForeName': 'Elke', 'Initials': 'E', 'LastName': 'Prestin', 'Affiliation': 'Dachverband Gemeindepsychiatrie, Cologne, Germany.'}, {'ForeName': 'Nils', 'Initials': 'N', 'LastName': 'Greve', 'Affiliation': 'Dachverband Gemeindepsychiatrie, Cologne, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Becker', 'Affiliation': 'Department of Psychiatry II, Ulm University, Bezirkskrankenhaus Günzburg, Günzburg, Germany.'}, {'ForeName': 'Reinhold', 'Initials': 'R', 'LastName': 'Kilian', 'Affiliation': 'Department of Psychiatry II, Ulm University, Bezirkskrankenhaus Günzburg, Günzburg, Germany.'}]",Trials,['10.1186/s13063-020-04492-y'] 2418,32605614,"A randomized controlled trial of a virtual reality based, approach-avoidance training program for alcohol use disorder: a study protocol.","BACKGROUND The approach-avoidance training program (AATP) has shown preliminary promise as an add-on to standard treatment for alcohol dependence. However, knowledge is lacking as to whether the effectiveness of AATP can be enhanced further when performed in a typical drinking situation. The main aim of this study is to investigate whether approach-avoidance training implemented in a virtual reality bar environment is superior to the classical joystick PC-version of the AATP. METHODS The study will be implemented as a randomized controlled trial. A total of 204consecutively enrolled alcohol use disorder (AUD) patients, recruited from alcohol inpatient clinics in Germany, Poland and Denmark, will be randomized into one of three groups at the start of standard alcohol treatment: group A) stimuli-relevant AATP + treatment as usual (TAU); group B) stimuli-relevant AATP in virtual reality + TAU, and group C) TAU only (control group). Treatment outcomes will be assessed at pre-treatment, post-treatment and 3-month follow-up. Repeated-measures ANOVA will be applied to compare the trajectories of the groups over time on drinking, craving and impulsiveness outcomes. It is hypothesized that the two experimental groups will achieve better treatment outcomes compared to group C and that group B will achieve better outcomes than group A. DISCUSSION This study is the first trial examining the effectiveness of stimuli-relevant AATP delivered in a VR environment. The use of VR has shown promise in enhancing the effectiveness of other psychological treatments and since AATP has already been shown effective as add-on treatment, it is of interest to investigate whether these effects can be further enhanced by implementing the program in more ecologically valid environments. If proven effective, the AATP-VR can, like the AATP, be implemented easily and cheaply as add-on treatment or continued care to enhance the effectiveness of current evidence-based treatment. TRIAL REGISTRATION ClinicalTrials.gov ID: NCT04283305 Registration date: 24.02.20.",2020,"If proven effective, the AATP-VR can, like the AATP, be implemented easily and cheaply as add-on treatment or continued care to enhance the effectiveness of current evidence-based treatment. ","['A total of 204consecutively enrolled alcohol use disorder (AUD) patients, recruited from alcohol inpatient clinics in Germany, Poland and Denmark']","['AATP', 'standard alcohol treatment: group A) stimuli-relevant AATP + treatment as usual (TAU); group B) stimuli-relevant AATP in virtual reality + TAU, and group C', 'TAU', 'approach-avoidance training', 'virtual reality based, approach-avoidance training program', 'avoidance training program (AATP', 'stimuli-relevant AATP']",[],"[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0001956', 'cui_str': 'Alcohol use disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0032356', 'cui_str': 'Poland'}, {'cui': 'C0011318', 'cui_str': 'Denmark'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0281351', 'cui_str': 'uridine triacetate'}, {'cui': 'C0441837', 'cui_str': 'Group C'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]",[],,0.0360521,"If proven effective, the AATP-VR can, like the AATP, be implemented easily and cheaply as add-on treatment or continued care to enhance the effectiveness of current evidence-based treatment. ","[{'ForeName': 'Angelina Isabella', 'Initials': 'AI', 'LastName': 'Mellentin', 'Affiliation': 'Unit for Clinical Alcohol Research, Unit for Psychiatric Research, Department of Clinical Research, University of Southern Denmark, J. B. Winsløwsvej 18, 5000, Odense Center, Denmark. amellentin@health.sdu.dk.'}, {'ForeName': 'Anette Søgaard', 'Initials': 'AS', 'LastName': 'Nielsen', 'Affiliation': 'Unit for Clinical Alcohol Research, Unit for Psychiatric Research, Department of Clinical Research, University of Southern Denmark, J. B. Winsløwsvej 18, 5000, Odense Center, Denmark.'}, {'ForeName': 'Leonie', 'Initials': 'L', 'LastName': 'Ascone', 'Affiliation': 'Neuroplasticity Research Group, Department of Psychiatry and Psychotherapy, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Janina', 'Initials': 'J', 'LastName': 'Wirtz', 'Affiliation': 'Neuroplasticity Research Group, Department of Psychiatry and Psychotherapy, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Jerzy', 'Initials': 'J', 'LastName': 'Samochowiec', 'Affiliation': 'Pomeranian University of Medicine, Szczecin, Poland.'}, {'ForeName': 'Jolanta', 'Initials': 'J', 'LastName': 'Kucharska-Mazur', 'Affiliation': 'Pomeranian University of Medicine, Szczecin, Poland.'}, {'ForeName': 'Friedrich', 'Initials': 'F', 'LastName': 'Schadow', 'Affiliation': 'Neuroplasticity Research Group, Department of Psychiatry and Psychotherapy, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Zofia', 'Initials': 'Z', 'LastName': 'Lebiecka', 'Affiliation': 'Pomeranian University of Medicine, Szczecin, Poland.'}, {'ForeName': 'Tomasz', 'Initials': 'T', 'LastName': 'Skoneczny', 'Affiliation': 'Pomeranian University of Medicine, Szczecin, Poland.'}, {'ForeName': 'Nicolai', 'Initials': 'N', 'LastName': 'Mistarz', 'Affiliation': 'Unit for Clinical Alcohol Research, Unit for Psychiatric Research, Department of Clinical Research, University of Southern Denmark, J. B. Winsløwsvej 18, 5000, Odense Center, Denmark.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Bremer', 'Affiliation': 'Neuroplasticity Research Group, Department of Psychiatry and Psychotherapy, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Kühn', 'Affiliation': 'Neuroplasticity Research Group, Department of Psychiatry and Psychotherapy, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}]",BMC psychiatry,['10.1186/s12888-020-02739-1'] 2419,32605633,"E-Freeze - a randomised controlled trial evaluating the clinical and cost effectiveness of a policy of freezing embryos followed by thawed frozen embryo transfer compared with a policy of fresh embryo transfer, in women undergoing in vitro fertilisation: a statistical analysis plan.","BACKGROUND The E-Freeze trial is a multi-centre randomised controlled trial of fresh versus frozen embryo transfer for women undergoing in vitro fertilisation. This paper describes the statistical analysis plan for the E-Freeze trial. METHODS AND DESIGN E-Freeze is a two-arm parallel-group, multi-centre, individually randomised controlled trial to determine if a policy of freezing embryos, followed by thawed frozen embryo transfer, results in a higher healthy baby rate when compared with the current policy of transferring fresh embryos. Couples undergoing their first, second or third cycle of in vitro fertilisation at fertility centres in the UK were randomised to either fresh or frozen embryo transfer. The primary outcome is a healthy baby, defined as a live singleton baby born at term with an appropriate weight for gestation. This paper describes the statistical analysis plan for the trial, including the analysis principles, definitions of outcomes, methods for primary analysis, pre-specified subgroup analysis and sensitivity analysis. This plan was finalised prior to completion of recruitment to the trial. TRIAL REGISTRATION ISRCTN registry: ISRCTN61225414 . Registered on 29 December 2015.",2020,"The primary outcome is a healthy baby, defined as a live singleton baby born at term with an appropriate weight for gestation.","['Couples undergoing their first, second or third cycle of in vitro fertilisation at fertility centres in the UK', 'women undergoing in vitro fertilisation']","['fresh versus frozen embryo transfer', 'freezing embryos followed by thawed frozen embryo transfer compared with a policy of fresh embryo transfer', 'fresh or frozen embryo transfer']","['healthy baby, defined as a live singleton baby born at term with an appropriate weight for gestation']","[{'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0015915', 'cui_str': 'In vitro fertilization'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0443224', 'cui_str': 'Fresh'}, {'cui': 'C0404110', 'cui_str': 'Frozen embryo transfer'}, {'cui': 'C0016701', 'cui_str': 'Freezing'}, {'cui': 'C0013935', 'cui_str': 'Embryos'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0242456', 'cui_str': 'Policy'}, {'cui': 'C0440732', 'cui_str': 'Fresh embryo'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}]","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}]",,0.250443,"The primary outcome is a healthy baby, defined as a live singleton baby born at term with an appropriate weight for gestation.","[{'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Bell', 'Affiliation': 'University of Oxford, Oxford, UK. jennifer.bell@npeu.ox.ac.uk.'}, {'ForeName': 'Pollyanna', 'Initials': 'P', 'LastName': 'Hardy', 'Affiliation': 'University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Greenland', 'Affiliation': 'University of Oxford, Oxford, UK.'}, {'ForeName': 'Edmund', 'Initials': 'E', 'LastName': 'Juszczak', 'Affiliation': 'University of Oxford, Oxford, UK.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Cole', 'Affiliation': 'University of Oxford, Oxford, UK.'}, {'ForeName': 'Abha', 'Initials': 'A', 'LastName': 'Maheshwari', 'Affiliation': 'NHS Grampian, Aberdeen, UK.'}, {'ForeName': 'Siladitya', 'Initials': 'S', 'LastName': 'Bhattacharya', 'Affiliation': 'University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Linsell', 'Affiliation': 'University of Oxford, Oxford, UK.'}]",Trials,['10.1186/s13063-020-04441-9'] 2420,32605893,First-iGAP: A Randomized Placebo-Controlled Phase II Study of First-line Intercalated Gefitinib and Pemetrexed-Cisplatin Chemotherapy for Never-Smoker Lung Adenocarcinoma Patients.,"BACKGROUND We aimed to evaluate whether intercalated combination of EGFR tyrosine kinase inhibitor gefitinib and chemotherapy improves survival outcomes in never-smokers with advanced lung adenocarcinoma. PATIENTS AND METHODS Never-smokers with chemo-naive stage IIIB/IV lung adenocarcinoma were randomly assigned to receive either gefitinib or placebo on days 5 to 18 of a 3-weekly cycle of pemetrexed and cisplatin. Chemotherapy was given up to 9 cycles, after which gefitinib or placebo was given daily. Patients in the placebo arm who had progression were crossed over to receive gefitinib. RESULTS Between June 2012 and December 2014, 76 patients with median age of 58.0 years were randomized, 39 on gefitinib and 37 on the placebo arm. EGFR mutation was positive in 34 (44.7%) patients. Baseline characteristics were well balanced between the 2 arms. The gefitinib arm had a better response rate (79.5% vs. 51.4%, P = .010) and median progression-free survival (PFS) (12.4 vs. 6.7 months, hazard ratio [HR] 0.49, P = .005) than the placebo arm; however, there was no statistically significant difference in median overall survival between the 2 arms (31.8 vs. 22.9 months, HR 0.78, P = .412). The PFS benefit of intercalated use of gefitinib over placebo was more apparent for patients with EGFR-mutant tumors (13.3 vs. 7.8 months, P = .025) than those with EGFR-wild-type tumors (8.2 vs. 6.6 months, P = .063). Overall, there was no difference in the frequency of severe adverse effect between the 2 arms. CONCLUSIONS Intercalated combination of gefitinib with pemetrexed and cisplatin was well tolerated and improved PFS in never-smoker patients with lung adenocarcinoma.",2020,"The gefitinib arm had a better response rate (79.5% vs. 51.4%, P = .010) and median progression-free survival (PFS) (12.4 vs. 6.7 months, hazard ratio [HR] 0.49, P = .005) than the placebo arm; however, there was no statistically significant difference in median overall survival between the 2 arms (31.8 vs. 22.9 months, HR 0.78, P = .412).","['Never-smokers with chemo-naive stage IIIB/IV lung adenocarcinoma', 'Never-Smoker Lung Adenocarcinoma Patients', 'never-smokers with advanced lung adenocarcinoma', 'never-smoker patients with lung adenocarcinoma', 'Between June 2012 and December 2014, 76 patients with median age of 58.0 years were randomized, 39 on gefitinib and 37 on the']","['Placebo', 'gefitinib or placebo', 'Chemotherapy', 'iGAP', 'pemetrexed and cisplatin', 'gefitinib with pemetrexed and cisplatin', 'First-line Intercalated Gefitinib and Pemetrexed-Cisplatin Chemotherapy', 'EGFR tyrosine kinase inhibitor gefitinib and chemotherapy', 'placebo']","['frequency of severe adverse effect', 'tolerated and improved PFS', 'median progression-free survival (PFS', 'median overall survival', 'EGFR mutation', 'response rate', 'survival outcomes']","[{'cui': 'C0425293', 'cui_str': 'Never smoked tobacco'}, {'cui': 'C0392920', 'cui_str': 'Antineoplastic chemotherapy regimen'}, {'cui': 'C0456599', 'cui_str': 'Stage 3B'}, {'cui': 'C0152013', 'cui_str': 'Adenocarcinoma of lung'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1122962', 'cui_str': 'gefitinib'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1122962', 'cui_str': 'gefitinib'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C1443775', 'cui_str': 'Epidermal growth factor receptor antagonist-containing product'}]","[{'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",76.0,0.372775,"The gefitinib arm had a better response rate (79.5% vs. 51.4%, P = .010) and median progression-free survival (PFS) (12.4 vs. 6.7 months, hazard ratio [HR] 0.49, P = .005) than the placebo arm; however, there was no statistically significant difference in median overall survival between the 2 arms (31.8 vs. 22.9 months, HR 0.78, P = .412).","[{'ForeName': 'Youngjoo', 'Initials': 'Y', 'LastName': 'Lee', 'Affiliation': 'Center for Lung Cancer, National Cancer Center Korea, Goyang, Republic of Korea.'}, {'ForeName': 'Hyae Young', 'Initials': 'HY', 'LastName': 'Kim', 'Affiliation': 'Center for Lung Cancer, National Cancer Center Korea, Goyang, Republic of Korea.'}, {'ForeName': 'Byung-Ho', 'Initials': 'BH', 'LastName': 'Nam', 'Affiliation': 'Center for Clinical Trials, National Cancer Center Korea, Goyang, Republic of Korea.'}, {'ForeName': 'Geon Kook', 'Initials': 'GK', 'LastName': 'Lee', 'Affiliation': 'Center for Lung Cancer, National Cancer Center Korea, Goyang, Republic of Korea.'}, {'ForeName': 'Heung Tae', 'Initials': 'HT', 'LastName': 'Kim', 'Affiliation': 'Center for Lung Cancer, National Cancer Center Korea, Goyang, Republic of Korea.'}, {'ForeName': 'Ji-Youn', 'Initials': 'JY', 'LastName': 'Han', 'Affiliation': 'Center for Lung Cancer, National Cancer Center Korea, Goyang, Republic of Korea.'}, {'ForeName': 'Hye Jin', 'Initials': 'HJ', 'LastName': 'An', 'Affiliation': 'Center for Lung Cancer, National Cancer Center Korea, Goyang, Republic of Korea.'}, {'ForeName': 'Jin Soo', 'Initials': 'JS', 'LastName': 'Lee', 'Affiliation': 'Center for Lung Cancer, National Cancer Center Korea, Goyang, Republic of Korea. Electronic address: jslee@ncc.re.kr.'}]",Clinical lung cancer,['10.1016/j.cllc.2020.05.003'] 2421,32605910,Circulating tumor DNA is prognostic and potentially predictive of eryaspase efficacy in second-line in patients with advanced pancreatic adenocarcinoma.,"BACKGROUND Eryaspase is composed of L-asparaginase encapsulated in erythrocytes and has demonstrated significant efficacy in a randomized phase 2 trial. We assessed the prognostic and predictive value of circulating tumor DNA (ctDNA) in patients plasma included in this trial. PATIENTS AND METHODS Samples prospectively collected pre-treatment were centrally analyzed by next-generation sequencing. Prognostic values of baseline ctDNA and ctDNA early changes between day 0 and 28 were assessed in both arms combined on objective response rate (ORR), progression free survival (PFS) and overall survival (OS); three groups were defined: negative ctDNA (Neg), ctDNA responders (Resp) and ctDNA non-responders (NResp). Predictive value of ctDNA for eryaspase efficacy was investigated. RESULTS CtDNA was positive at baseline in 77 patients out of the 113 tested patients (68%). Detectable ctDNA was an independent negative prognostic factor for OS (4.6 vs 8.8 months; p=0.0025) and PFS (1.6 vs 3.3 months; p=0.00043). Early change in ctDNA levels was correlated with ORR (20 %, 26%, 0%; p<0.04), PFS (3.7, 3.4, 1.6 months; p<0.0001) and OS (11.7, 6.5, 4.3 months; p<0.0001) according to the three defined groups (Neg, Res, NResp, respectively). In patients with ctDNA detectable at baseline, eryaspase was associated with better PFS (HR=0.53; 95% CI: 0.3-0.94) and OS (HR=0.52; 95% CI: 0.29-0.91). CONCLUSIONS We confirm from a prospective randomized trial that 1/ the presence of ctDNA at baseline is a major prognostic factor, 2/ the early change of ctDNA correlates with treatment outcome and 3/ the ctDNA could be a predictive biomarker of eryaspase efficacy.",2020,Detectable ctDNA was an independent negative prognostic factor for OS (4.6 vs 8.8 months; p=0.0025) and PFS (1.6 vs 3.3 months; p=0.00043).,"['Samples prospectively collected pre-treatment were centrally analyzed by next-generation sequencing', '77 patients out of the 113 tested patients (68', 'patients plasma included in this trial', 'patients with advanced pancreatic adenocarcinoma']",[],"['objective response rate (ORR), progression free survival (PFS) and overall survival (OS', 'ctDNA levels', 'negative prognostic factor for OS', 'PFS']","[{'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C2936621', 'cui_str': 'Next-Generation Sequencing'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0281361', 'cui_str': 'Adenocarcinoma of pancreas'}]",[],"[{'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C3827014', 'cui_str': 'Cell-Free Tumor DNA'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C1514474', 'cui_str': 'Prognostic Factors'}]",113.0,0.147504,Detectable ctDNA was an independent negative prognostic factor for OS (4.6 vs 8.8 months; p=0.0025) and PFS (1.6 vs 3.3 months; p=0.00043).,"[{'ForeName': 'Jean-Baptiste', 'Initials': 'JB', 'LastName': 'Bachet', 'Affiliation': 'Department of Gastroenterology and Digestive Oncology, Pitié-Salpêtrière Hospital, Sorbonne University, UPMC University, Paris 06 jean-baptiste.bachet@aphp.fr.'}, {'ForeName': 'Helene F', 'Initials': 'HF', 'LastName': 'Blons', 'Affiliation': 'U1147, INSERM.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Hammel', 'Affiliation': 'Digestive Oncology, Beaujon University Hospital.'}, {'ForeName': 'Iman', 'Initials': 'I', 'LastName': 'El Hariry', 'Affiliation': '1 Main Street, ERYTECH, One Main Street, Suite 1150, Cambridge, MA 02142, USA.'}, {'ForeName': 'Fabienne', 'Initials': 'F', 'LastName': 'Portales', 'Affiliation': 'Medical Oncology Department, Institut du Cancer de Montpellier.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Mineur', 'Affiliation': 'Institut Sainte Catherine, Gastrointestinal and Liver Cancer Unit, Chemin de baigne pieds, Avignon, France.'}, {'ForeName': 'Jean-Philippe', 'Initials': 'JP', 'LastName': 'Metges', 'Affiliation': 'Department of Medical Oncology, University Hospital.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Mulot', 'Affiliation': 'Université Paris Descartes.'}, {'ForeName': 'Camille', 'Initials': 'C', 'LastName': 'Bourreau', 'Affiliation': 'Biological Ressources Center Epigenetec (BB-0033-00055) Université de Paris, INSERM.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Cain', 'Affiliation': 'ERYTECH, One Main Street, Suite 1150, Cambridge, MA 02142, USA.'}, {'ForeName': 'Jerome', 'Initials': 'J', 'LastName': 'Cros', 'Affiliation': 'Institute Curie.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Laurent-Puig', 'Affiliation': 'UMR-S1147, Université Paris Descartes.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-20-0950'] 2422,32602592,Cognitive evolutionary therapy versus standard cognitive therapy for depression: A single-blinded randomized clinical trial.,"OBJECTIVE To compare the efficacy of cognitive evolutionary therapy (CET) with cognitive therapy (CT) for depression. METHODS Ninety-seven participants (78 females/19 males) were randomized to a single-blinded controlled trial (CET: n = 51 vs. CT: n = 46). Assessments were conducted at baseline, Sessions 4 and 8, posttreatment, and 3-month follow-up. Clinical diagnoses were made with Structured Clinical Interview for DSM-IV (SCID) and self-reports for depression and secondary outcomes. RESULTS Although both groups showed significant reductions in depressive symptomatology, the overall Time × Treatment group interaction in the intent to treat analysis was not significant (p = .770, posttreatment: d = 0.39). However, CET was superior to CT at increasing engagement in social and enjoyable activities (p = .040, posttreatment: d = 0.83, p = .040) and showed greater reductions than the CT group in behavioral inhibition/avoidance (p = .047, d = 0.62). The between-group differences generally diminished at the 3-month follow-up. CONCLUSIONS CET is a novel therapy for depression that may add therapeutic benefits beyond those of CT.",2020,"However, CET was superior to CT at increasing engagement in social and enjoyable activities (p = .040, posttreatment: d = 0.83, p = .040) and showed greater reductions than the CT group in behavioral inhibition/avoidance (p = .047, d = 0.62).","['Ninety-seven participants (78\xa0females/19\xa0males', 'depression']","['CT', 'cognitive evolutionary therapy (CET) with cognitive therapy (CT', 'Cognitive evolutionary therapy versus standard cognitive therapy', 'CET']","['depressive symptomatology', 'behavioral inhibition/avoidance', 'social and enjoyable activities']","[{'cui': 'C0439073', 'cui_str': '97'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",97.0,0.0923318,"However, CET was superior to CT at increasing engagement in social and enjoyable activities (p = .040, posttreatment: d = 0.83, p = .040) and showed greater reductions than the CT group in behavioral inhibition/avoidance (p = .047, d = 0.62).","[{'ForeName': 'Cezar', 'Initials': 'C', 'LastName': 'Giosan', 'Affiliation': 'Department of Psychology, University of Bucharest, Bucharest, Romania.'}, {'ForeName': 'Oana', 'Initials': 'O', 'LastName': 'Cobeanu', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Babes-Bolyai University, Cluj-Napoca, Romania.'}, {'ForeName': 'Katarzyna', 'Initials': 'K', 'LastName': 'Wyka', 'Affiliation': 'Department of Epidemiology and Biostatistics, Graduate School of Public Health and Health Policy, City University of New York, New York, USA.'}, {'ForeName': 'Vlad', 'Initials': 'V', 'LastName': 'Muresan', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Babes-Bolyai University, Cluj-Napoca, Romania.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Mogoase', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Babes-Bolyai University, Cluj-Napoca, Romania.'}, {'ForeName': 'Aurora', 'Initials': 'A', 'LastName': 'Szentagotai', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Babes-Bolyai University, Cluj-Napoca, Romania.'}, {'ForeName': 'Loretta S', 'Initials': 'LS', 'LastName': 'Malta', 'Affiliation': 'Capital Psychological Associates, Albany, New York, USA.'}, {'ForeName': 'Ramona', 'Initials': 'R', 'LastName': 'Moldovan', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, Babes-Bolyai University, Cluj-Napoca, Romania.'}]",Journal of clinical psychology,['10.1002/jclp.22991'] 2423,32602616,Safety and Efficacy of Budesonide for Liver Transplant Immune Suppression: Results of a Pilot Phase 2a trial.,"BACKGROUND AND AIMS Despite adverse effects like hyperglycemia, New Onset Diabetes After Transplant (NODAT) and infectious complications; corticosteroids remains an important part of liver transplant (LT) immune suppression. Budesonide, a synthetic corticosteroid, undergoes extensive first-pass hepatic metabolism with only 10% systemic bioavailability, providing an opportunity for improved toxicity-therapeutic ratio. Although effective in the treatment of autoimmune hepatitis, effects of budesonide for LT immune suppression are unknown. APPROACH AND RESULTS We conducted a single center phase 2a trial to study the safety and efficacy of budesonide immunosuppressive therapy. From July 2017 to November 2018, twenty subjects undergoing first LT received budesonide tapering doses (9mg-3mg) for 12 weeks. Subjects were compared to matched controls that received prednisone from the same time period. Additionally, both groups received calcineurin inhibitors and mycophenolate. Outcome measures at week 24 included rates of biopsy proven Acute Cellular Rejection (ACR), NODAT (Glycated Hemoglobin > 6.4) and infectious complications. In the budesonide arm, one subject developed ACR at week 6 and was removed from the study. Another subject stopped the study drug at week 8 due to persistent nausea. Rates of ACR were similar between budesonide and control groups (5% vs 5%, p=1.00). Three patients in the control group developed NODAT vs none in budesonide group (15% vs 0%, p=0.23). There were six infections in the control group as compared to none in the budesonide group (30% vs 0, p=0.02). CONCLUSION These pilot data suggests that Budesonide has the potential to be a safe and effective alternative to prednisone for LT immune suppression while reducing steroid induced infections and NODAT. Randomized controlled trials are required to validate these findings.",2020,"Rates of ACR were similar between budesonide and control groups (5% vs 5%, p=1.00).","['Liver Transplant Immune Suppression', 'From July 2017 to November 2018, twenty subjects undergoing first LT received']","['prednisone', 'Budesonide', 'budesonide immunosuppressive therapy', 'budesonide', 'calcineurin inhibitors and mycophenolate']","['rates of biopsy proven Acute Cellular Rejection (ACR), NODAT (Glycated Hemoglobin > 6.4) and infectious complications', 'Safety and Efficacy', 'safety and efficacy', 'toxicity-therapeutic ratio', 'Rates of ACR']","[{'cui': 'C0023911', 'cui_str': 'Transplantation of liver'}, {'cui': 'C0021079', 'cui_str': 'Immunosuppressive therapy'}]","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0054201', 'cui_str': 'Budesonide'}, {'cui': 'C0021079', 'cui_str': 'Immunosuppressive therapy'}, {'cui': 'C1453118', 'cui_str': 'CABIN1 protein, human'}, {'cui': 'C0883242', 'cui_str': 'MYCOPHENOLATE'}]","[{'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0456369', 'cui_str': 'Proven'}, {'cui': 'C0877453', 'cui_str': 'Acute cellular rejection'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C4517822', 'cui_str': '6.4'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0678793', 'cui_str': 'Therapeutic Index'}]",20.0,0.0575914,"Rates of ACR were similar between budesonide and control groups (5% vs 5%, p=1.00).","[{'ForeName': 'Khurram', 'Initials': 'K', 'LastName': 'Bari', 'Affiliation': 'University of Cincinnati, Division of Digestive Diseases, Department of Medicine, Cincinnati, Ohio, USA.'}, {'ForeName': 'Shimul A', 'Initials': 'SA', 'LastName': 'Shah', 'Affiliation': 'University of Cincinnati, Division of Transplant Surgery, Department of Surgery, Cincinnati, Ohio, USA.'}, {'ForeName': 'Tiffany E', 'Initials': 'TE', 'LastName': 'Kaiser', 'Affiliation': 'University of Cincinnati, Division of Digestive Diseases, Department of Medicine, Cincinnati, Ohio, USA.'}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Cohen', 'Affiliation': 'University of Cincinnati, Division of Endocrinology, Diabetes and Metabolism, Department of Medicine, Cincinnati, Ohio, USA.'}, {'ForeName': 'Nadeem', 'Initials': 'N', 'LastName': 'Anwar', 'Affiliation': 'University of Cincinnati, Division of Digestive Diseases, Department of Medicine, Cincinnati, Ohio, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Kleesattel', 'Affiliation': 'University of Cincinnati, Department of Internal Medicine, Cincinnati, Ohio, USA.'}, {'ForeName': 'Kenneth E', 'Initials': 'KE', 'LastName': 'Sherman', 'Affiliation': 'University of Cincinnati, Division of Digestive Diseases, Department of Medicine, Cincinnati, Ohio, USA.'}]",Liver transplantation : official publication of the American Association for the Study of Liver Diseases and the International Liver Transplantation Society,['10.1002/lt.25837'] 2424,32602744,The Effect of Therapeutic Meibomian Glands Expression on Evaporative Dry Eye: A Prospective Randomized Controlled Trial.,"PURPOSE To determine the clinical benefits of Meibomian gland expression therapy for the treatment of dry-eye disease caused by Meibomian gland dysfunction (MGD). Methods : In a prospective randomized controlled double-masked trial, 87 eyes of 44 patients with MGD and dry eye symptoms were enrolled. Patients were randomly assigned into two groups; a study group which received therapeutic Meibomian gland expression once every month, and a control group which received sham treatment. All patients received treatment with artificial tears. RESULTS One week after the first treatment, the Ocular Surface Disease Index (OSDI) score improved significantly in the study group (mean change -18.5±21.2, p=0.01) but not in the control group (-3.8±15.8, p=0.16); after one month both groups improved significantly (-20.5±19 p=0.001), in the study group and -6.5±11, p=0.016 in the control group). The improvement continued at two months in the study group (-28.4±26.1, P<0.0001) and in the control group (-9.6±9.9, p=0.007). The blepharitis questionnaire score improved in the study group compared to controls after one week (-9.95±12.52 versus -1.77±9.1, p=0.03) one month (-11.5±10.9 versus -1.1±9.4, p=0.02) and two months (-16.5±8.0 versus -8.8±11.7, p=0.02). Burning sensation was significantly reduced only in the study group. Mean change after two months treatment was -2.00±1.2583 (p < 0.0001) vs -0.67±1.44 (p=0.08). The trend was similar in Eye lid scales. Conjunctival hyperemia improved only in the study group one week after the treatment (-0.12±0.32 p=0.03). CONCLUSION Therapeutic Meibomian gland expression improves dry eye symptoms in subjects with MGD, compared to conventional treatment with artificial tears.",2020,Mean change after two months treatment was -2.00±1.2583 (p < 0.0001),"['87 eyes of 44 patients with MGD and dry eye symptoms were enrolled', 'dry-eye disease caused by Meibomian gland dysfunction (MGD', 'subjects with MGD', 'Evaporative Dry Eye']","['therapeutic Meibomian gland expression once every month, and a control group which received sham treatment', 'Meibomian gland expression therapy', 'artificial tears', 'Therapeutic Meibomian Glands Expression']","['Ocular Surface Disease Index (OSDI) score', 'Mean change', 'dry eye symptoms', 'Burning sensation', 'Conjunctival hyperemia', 'blepharitis questionnaire score', 'Eye lid scales']","[{'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1275684', 'cui_str': 'Meibomian gland dysfunction'}, {'cui': 'C0013238', 'cui_str': 'Dry Eye Disease'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C5197850', 'cui_str': 'Evaporative Dry Eye Syndrome'}]","[{'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0025181', 'cui_str': 'Structure of meibomian gland'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C2608262', 'cui_str': 'Artificial Tears'}]","[{'cui': 'C1557335', 'cui_str': 'Ocular surface disease'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0013238', 'cui_str': 'Dry Eye Disease'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0085624', 'cui_str': 'Burning sensation'}, {'cui': 'C1761613', 'cui_str': 'Conjunctival hyperemia'}, {'cui': 'C0005741', 'cui_str': 'Blepharitis'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",87.0,0.0465455,Mean change after two months treatment was -2.00±1.2583 (p < 0.0001),"[{'ForeName': 'Igor', 'Initials': 'I', 'LastName': 'Kaiserman', 'Affiliation': 'Department of Ophthalmology, Barzilai University Medical Center , Ashkelon, Israel.'}, {'ForeName': 'Gilad', 'Initials': 'G', 'LastName': 'Rabina', 'Affiliation': 'Department of Ophthalmology, Tel Aviv Sourasky Medical Center, affiliated to the Sackler Faculty of Medicine, Tel Aviv University , Israel.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Mimouni', 'Affiliation': 'Department of Ophthalmology, Rambam Health Care Campus , Haifa, Israel.'}, {'ForeName': 'Naava B', 'Initials': 'NB', 'LastName': 'Sadi Optom', 'Affiliation': 'Department of Ophthalmology, Barzilai University Medical Center , Ashkelon, Israel.'}, {'ForeName': 'Nitsan', 'Initials': 'N', 'LastName': 'Duvdevan', 'Affiliation': 'Department of Ophthalmology, Rambam Health Care Campus , Haifa, Israel.'}, {'ForeName': 'Shmuel', 'Initials': 'S', 'LastName': 'Levartovsky', 'Affiliation': 'Department of Ophthalmology, Barzilai University Medical Center , Ashkelon, Israel.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Ben David', 'Affiliation': 'Department of Ophthalmology, Barzilai University Medical Center , Ashkelon, Israel.'}]",Current eye research,['10.1080/02713683.2020.1789663'] 2425,32602755,"Successful Treatment of the face post acne erythema Using a Topically Applied Selective alpha 1-Adrenergic Receptor Agonist, Oxymetazoline 1.5%, A controlled left to right face comparative trial.","Background: Post-inflammatory erythema (PIE) is a common sequalae of acne inflammation, persistent post acne erythema (PAE) is cosmetically unacceptable and sometimes its complete clearance could not be achieved. Oxymetazoline (OXZ) is a synthetic, direct-acting, sympathomimetic agonist that is highly selective for the 1α-adrenoceptor. It is a potent vasoconstrictor and well known for its ability to clinically ""get the red out"". The aim of this study was to evaluate the efficacy and safety of topical oxymetazoline (OXZ) 1.5% in treatment of post acne erythema (PAE) in a left to right face comparative study. Methods: This study was conducted on 40 patients diagnosed with post acne erythema for at least 3 months, the left side of the face was treated with topical OXZ 1.5% in liposomal base and was compared to the right side to which topical lipogel was applied as a control. Results: According to the investigator's global assessment of photographs and the analysis of erythema with image analysis software, topical OXZ was significantly effective in diminishing PAE when compared to topical placebo lipogel Conclusion: topical OXZ is a safe and effective treatment for post-acne erythema.",2020,"This study was conducted on 40 patients diagnosed with post acne erythema for at least 3 months, the left side of the face was treated with topical OXZ 1.5% in liposomal base and was compared to the right side to which topical lipogel was applied as a control. ","['post acne erythema', '40 patients diagnosed with post acne erythema for at least 3 months, the left side of the face was treated with']","['topical oxymetazoline (OXZ', 'OXZ', 'topical OXZ 1.5% in liposomal', 'Oxymetazoline (OXZ']",['efficacy and safety'],"[{'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0001144', 'cui_str': 'Acne vulgaris'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0030071', 'cui_str': 'Oxymetazoline'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0023828', 'cui_str': 'Liposomes'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",40.0,0.0250483,"This study was conducted on 40 patients diagnosed with post acne erythema for at least 3 months, the left side of the face was treated with topical OXZ 1.5% in liposomal base and was compared to the right side to which topical lipogel was applied as a control. ","[{'ForeName': 'Naglaa', 'Initials': 'N', 'LastName': 'Agamia', 'Affiliation': 'Department of Dermatology, Venereology and Andrology, Faculty of Medicine, Alexandria University, Egypt.'}, {'ForeName': 'Marwa', 'Initials': 'M', 'LastName': 'Essawy', 'Affiliation': 'Oral Pathology Department, Faculty of Dentistry, Alexandria University, Egypt.'}, {'ForeName': 'Amira', 'Initials': 'A', 'LastName': 'Kassem', 'Affiliation': 'Clinical Pharmacy & Pharmacy Practice Department, Faculty of Pharmacy, Damanhour University, Egypt.'}]",The Journal of dermatological treatment,['10.1080/09546634.2020.1789045'] 2426,32602793,Blackcurrant extract does not affect the speed-duration relationship during high-intensity running.,"Anthocyanin-rich blackcurrant extract (BC) has been shown to ergogenically aid high-intensity exercise. Capacity for such exercise is evaluated by the hyperbolic speed-tolerable duration (S-D tol ) relationship. Therefore, in double-blinded and cross-over randomised controlled trials, 15 males underwent treadmill running incremental exercise testing and were assessed for S-D tol , quantified by critical speed (CS) and D ' (distance), and assessments of time to exhaustion performance to empirically test the limits of the S-D tol relationship, after daily supplementation of 300 mg/d BC (105 mg/d anthocyanin) or placebo. Supplementation with BC did not change CS (placebo 12.1 ± 1.0 km/h vs BC 11.9 ± 1.0 km/h, p  >   .05) or D ' (placebo 918.6 ± 223.2 m vs BC 965.2 ± 231.2 m, p  > .05), although further analysis indicated D ' increased in 60% of subject ( p  =   .08), indicating a trend toward cohorts potentially benefiting from BC supplementation. BC supplementation did not change time to exhaustion at or above CS, maximal oxygen uptake (VO 2max ), lactate threshold (LT), submaximal running economy (C R ), or substrate utilisation during exercise (all p  >   .05). In conclusion, we could not detect any beneficial effect of BC supplementation during high-intensity running exercise, including the determining factors S-D tol relationship, VO 2max , LT or C R . Hence, no ergogenic effect was observed.",2020,"BC supplementation did not change time to exhaustion at or above CS, maximal oxygen uptake (VO 2max ), lactate threshold (LT), submaximal running economy (C R ), or substrate utilisation during exercise (all p  >   .05).",['15 males underwent'],"['BC supplementation', 'Anthocyanin-rich blackcurrant extract (BC', 'treadmill running incremental exercise testing', 'placebo']","['D ', 'speed-duration relationship', 'change time to exhaustion at or above CS, maximal oxygen uptake (VO 2max ), lactate threshold (LT), submaximal running economy (C R ), or substrate utilisation during exercise']","[{'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0453277', 'cui_str': 'Blackcurrants'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0003161', 'cui_str': 'Anthocyanin'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0392674', 'cui_str': 'Exhaustion'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0587107', 'cui_str': 'During exercise'}]",,0.464601,"BC supplementation did not change time to exhaustion at or above CS, maximal oxygen uptake (VO 2max ), lactate threshold (LT), submaximal running economy (C R ), or substrate utilisation during exercise (all p  >   .05).","[{'ForeName': 'Eleni', 'Initials': 'E', 'LastName': 'Pastellidou', 'Affiliation': 'School of Life Sciences and Institute of Cardiovascular and Medical Sciences, College of Medical, Veterinary and Life Sciences, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Gillespie', 'Affiliation': 'School of Life Sciences and Institute of Cardiovascular and Medical Sciences, College of Medical, Veterinary and Life Sciences, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Anton', 'Initials': 'A', 'LastName': 'McGrotty', 'Affiliation': 'School of Life Sciences and Institute of Cardiovascular and Medical Sciences, College of Medical, Veterinary and Life Sciences, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Spence', 'Affiliation': 'School of Life Sciences and Institute of Cardiovascular and Medical Sciences, College of Medical, Veterinary and Life Sciences, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'McCloskey', 'Affiliation': 'School of Life Sciences and Institute of Cardiovascular and Medical Sciences, College of Medical, Veterinary and Life Sciences, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Lynsey', 'Initials': 'L', 'LastName': 'Johnston', 'Affiliation': 'School of Life Sciences and Institute of Cardiovascular and Medical Sciences, College of Medical, Veterinary and Life Sciences, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Wilson', 'Affiliation': 'School of Life Sciences and Institute of Cardiovascular and Medical Sciences, College of Medical, Veterinary and Life Sciences, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Ole J', 'Initials': 'OJ', 'LastName': 'Kemi', 'Affiliation': 'School of Life Sciences and Institute of Cardiovascular and Medical Sciences, College of Medical, Veterinary and Life Sciences, University of Glasgow, Glasgow, UK.'}]",European journal of sport science,['10.1080/17461391.2020.1771428'] 2427,32602803,Participant Satisfaction and Acceptability of a Culturally Adapted Brief Intervention to Reduce Unhealthy Alcohol Use Among Latino Immigrant Men.,"Latino immigrant men are at increased risk for unhealthy alcohol use, yet few interventions have been designed to meet their unique needs. The current study assessed participant satisfaction and acceptability of a culturally adapted brief intervention to reduce unhealthy alcohol use in this population. Adaptations to the brief intervention included delivering it in Spanish by promotores in a community setting. The mixed methods approach included surveys ( N = 73) and in-depth interviews ( N = 20) with participants in a pilot randomized controlled trial. The study drew on Sekhon's theoretical framework of acceptability to asses affective attitude, burden, and perceived effectiveness of the intervention, along with satisfaction with the content, setting, and promotor . Participants' survey responses indicated that they were highly satisfied with the content, setting, and delivery of the brief intervention. In interviews participants noted that the brief intervention helped them reflect on their drinking behaviors, that they perceived promotores to be a trusted source of health information, and that they liked receiving personalized feedback via tablets. Some participants found the feedback did not match their own perceptions of their alcohol use and wanted clearer advice on how to reduce their drinking. Men felt they would benefit from more contact with promotores . These findings suggest that Latino immigrant men in this study were receptive to the culturally adapted brief intervention. Future interventions may be more effective if they include multiple contacts with promotores and more directive guidance on strategies to reduce drinking.",2020,The current study assessed participant satisfaction and acceptability of a culturally adapted brief intervention to reduce unhealthy alcohol use in this population.,"['Latino Immigrant Men', 'Latino immigrant men']",['Culturally Adapted Brief Intervention to Reduce Unhealthy Alcohol Use'],[],"[{'cui': 'C0086528', 'cui_str': 'Latinos'}, {'cui': 'C0282163', 'cui_str': 'Immigrant'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0010453', 'cui_str': 'Culture'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}]",[],,0.0241914,The current study assessed participant satisfaction and acceptability of a culturally adapted brief intervention to reduce unhealthy alcohol use in this population.,"[{'ForeName': 'Vanessa N', 'Initials': 'VN', 'LastName': 'Torres', 'Affiliation': 'Department of Health Services, University of Washington, Seattle, USA.'}, {'ForeName': 'Emily C', 'Initials': 'EC', 'LastName': 'Williams', 'Affiliation': 'Department of Health Services, University of Washington, Seattle, USA.'}, {'ForeName': 'Rachel M', 'Initials': 'RM', 'LastName': 'Ceballos', 'Affiliation': 'Department of Health Services, University of Washington, Seattle, USA.'}, {'ForeName': 'Dennis M', 'Initials': 'DM', 'LastName': 'Donovan', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Washington, Seattle, USA.'}, {'ForeName': 'India J', 'Initials': 'IJ', 'LastName': 'Ornelas', 'Affiliation': 'Department of Health Services, University of Washington, Seattle, USA.'}]",American journal of men's health,['10.1177/1557988320925652'] 2428,32602830,Day hospital versus intensive outpatient mentalization-based treatment: 3-year follow-up of patients treated for borderline personality disorder in a multicentre randomized clinical trial.,"BACKGROUND Two types of mentalization-based treatment (MBT), day hospital MBT (MBT-DH) and intensive outpatient MBT (MBT-IOP), have been shown to be effective in treating patients with borderline personality disorder (BPD). This study evaluated trajectories of change in a multi-site trial of MBT-DH and MBT-IOP at 36 months after the start of treatment. METHODS All 114 patients (MBT-DH n = 70, MBT-IOP n = 44) from the original multicentre trial were assessed at 24, 30 and 36 months after the start of treatment. The primary outcome was symptom severity measured with the Brief Symptom Inventory. Secondary outcome measures included borderline symptomatology, personality and interpersonal functioning, quality of life and self-harm. Data were analysed using multilevel modelling and the intention-to-treat principle. RESULTS Patients in both MBT-DH and MBT-IOP maintained the substantial improvements made during the intensive treatment phase and showed further gains during follow-up. Across both conditions, 83% of patients improved in terms of symptom severity, and 97% improved on borderline symptomatology. No significant differences were found between MBT-DH and MBT-IOP at 36 months after the start of treatment. However, trajectories of change were different. Whereas patients in MBT-DH showed greater improvement during the intensive treatment phase, patients in MBT-IOP showed greater continuing improvement during follow-up. CONCLUSIONS Patients in both conditions showed similar large improvements over the course of 36 months, despite large differences in treatment intensity. MBT-DH and MBT-IOP were associated with different trajectories of change. Cost-effectiveness considerations and predictors of differential treatment outcome may further inform optimal treatment selection.",2020,No significant differences were found between MBT-DH and MBT-IOP at 36 months after the start of treatment.,['patients with borderline personality disorder (BPD'],"['MBT-DH and MBT-IOP', 'mentalization-based treatment (MBT), day hospital MBT (MBT-DH) and intensive outpatient MBT (MBT-IOP', 'Day hospital versus intensive outpatient mentalization-based treatment: 3-year follow-up']","['symptom severity measured with the Brief Symptom Inventory', 'borderline symptomatology, personality and interpersonal functioning, quality of life and self-harm', 'symptom severity', 'MBT-DH and MBT-IOP', 'borderline symptomatology']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006012', 'cui_str': 'Borderline personality disorder'}]","[{'cui': 'C4704687', 'cui_str': 'Mentalizing'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0578862', 'cui_str': 'Intraocular pressure finding'}, {'cui': 'C0587438', 'cui_str': 'Day hospital'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0003944', 'cui_str': 'As If Personality'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0085271', 'cui_str': 'Self-injurious behavior'}, {'cui': 'C4704687', 'cui_str': 'Mentalizing'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0578862', 'cui_str': 'Intraocular pressure finding'}]",114.0,0.16026,No significant differences were found between MBT-DH and MBT-IOP at 36 months after the start of treatment.,"[{'ForeName': 'Maaike L', 'Initials': 'ML', 'LastName': 'Smits', 'Affiliation': 'Viersprong Institute for Studies on Personality Disorders, Halsteren, The Netherlands.'}, {'ForeName': 'Dine J', 'Initials': 'DJ', 'LastName': 'Feenstra', 'Affiliation': 'Viersprong Institute for Studies on Personality Disorders, Halsteren, The Netherlands.'}, {'ForeName': 'Dawn L', 'Initials': 'DL', 'LastName': 'Bales', 'Affiliation': 'Expertcentre MBT-Nederland, Bergen op Zoom, The Netherlands.'}, {'ForeName': 'Matthijs', 'Initials': 'M', 'LastName': 'Blankers', 'Affiliation': 'Department of Research, Arkin Mental Health Care, Amsterdam, The Netherlands.'}, {'ForeName': 'Jack J M', 'Initials': 'JJM', 'LastName': 'Dekker', 'Affiliation': 'Department of Research, Arkin Mental Health Care, Amsterdam, The Netherlands.'}, {'ForeName': 'Zwaan', 'Initials': 'Z', 'LastName': 'Lucas', 'Affiliation': 'Lentis, Groningen, The Netherlands.'}, {'ForeName': 'Jan H', 'Initials': 'JH', 'LastName': 'Kamphuis', 'Affiliation': 'Viersprong Institute for Studies on Personality Disorders, Halsteren, The Netherlands.'}, {'ForeName': 'Jan J V', 'Initials': 'JJV', 'LastName': 'Busschbach', 'Affiliation': 'Viersprong Institute for Studies on Personality Disorders, Halsteren, The Netherlands.'}, {'ForeName': 'Roel', 'Initials': 'R', 'LastName': 'Verheul', 'Affiliation': 'CEO De Viersprong, Halsteren, The Netherlands.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Luyten', 'Affiliation': 'Viersprong Institute for Studies on Personality Disorders, Halsteren, The Netherlands.'}]",Psychological medicine,['10.1017/S0033291720002123'] 2429,32602966,Effect of combined physical training on cognitive function in people with epilepsy: Results from a randomized controlled trial.,"OBJECTIVE To examine the effect of 12-week exercise program on cognitive function in people with epilepsy. METHODS Twenty-one physically inactive subjects were randomized into two groups: the exercise group (EG) or the control group (CG). EG performed 12 weeks of combined physical training. CG was advised to maintain usual daily activities. EG received a structured, individually supervised exercise program with two 60-minute sessions per week. Each session included warmup (5-minutes), aerobic (15-20 minutes at 14-17 on Borg scale), strength (2-3 sets, 10-15 repetitions), and 5-minute active stretches. Sociodemographic characteristics, clinical information, memory (Digit Span Test [DST]), executive function (Trail Making Test [TMT] A and B), Stroop Color and Word Test, a verbal fluency task, global cognitive function (Montreal Cognitive Assessment [MoCA]), anthropometric measurements (weight, height, and hip and waist circumferences), cardiorespiratory fitness (maximal oxygen consumption [VO 2 max]), and strength (dynamometer) were measured at baseline and after the 12-week intervention. RESULTS Exercise decreased time spent on TMT-A from baseline to postintervention (difference = -7.9 seconds, 95% confidence interval [CI] = -14.5 to -1.3, P = .023). EG improved total number of words on the verbal fluency task after intervention (difference = 8.1 words, 95% CI = 3.0 to 13.2, P = .002). EG also improved the score on MoCA at 1.7 (95% CI = 0.1 to 3.3, P = .043) points. We observed a 22.4% (95% CI = 13.1 to 31.6, P = .021) improvement in executive function in EG. No effect of group, time, or group × time was observed on any other cognitive test. Changes in VO 2 max were negatively associated with changes in performance on DST (r = -.445, P = .049) and overall memory score (r = -.544, P = .042). SIGNIFICANCE This randomized controlled trial provided the first evidence that combined physical training improves executive function in adults with epilepsy, showing main improvements in attention and language tasks. Physical exercise should be encouraged for people with epilepsy to reduce the burden on cognitive function associated with this disease.",2020,"EG improved total number of words on the verbal fluency task after intervention (difference = 8.1 words, 95% CI = 3.0 to 13.2, P = .002).","['people with epilepsy', 'Twenty-one physically inactive subjects', 'adults with epilepsy']","['exercise group (EG) or the control group (CG', 'Physical exercise', 'exercise program', 'TMT', 'combined physical training', 'CG']","['score on MoCA', 'time spent on TMT', 'Stroop Color and Word Test, a verbal fluency task, global cognitive function (Montreal Cognitive Assessment [MoCA]), anthropometric measurements (weight, height, and hip and waist circumferences), cardiorespiratory fitness (maximal oxygen consumption [VO 2 max]), and strength (dynamometer', 'executive function', 'cognitive function', 'overall memory score', 'performance on DST', 'total number of words on the verbal fluency task', 'Sociodemographic characteristics, clinical information, memory (Digit Span Test [DST]), executive function (Trail Making Test', 'attention and language tasks']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0014544', 'cui_str': 'Epilepsy'}, {'cui': 'C3715213', 'cui_str': '21'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C1276393', 'cui_str': 'Group exercise'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0040604', 'cui_str': 'Trail making test'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0025750', 'cui_str': ""3,3'-Dichloro-4,4'-Diaminodiphenylmethane""}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0040604', 'cui_str': 'Trail making test'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C4555213', 'cui_str': 'Assessment using Montreal cognitive assessment'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C2981722', 'cui_str': 'Cardiorespiratory Fitness'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0180572', 'cui_str': 'Dynamometer'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0262967', 'cui_str': 'Dihydrostreptomycin'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0582802', 'cui_str': 'Digit structure'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0023008', 'cui_str': 'Language'}]",21.0,0.0861104,"EG improved total number of words on the verbal fluency task after intervention (difference = 8.1 words, 95% CI = 3.0 to 13.2, P = .002).","[{'ForeName': 'Natan', 'Initials': 'N', 'LastName': 'Feter', 'Affiliation': 'Centre for Research on Exercise, Physical Activity, and Health, School of Human Movement and Nutritional Sciences, University of Queensland, Brisbane, Queensland, Australia.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Alt', 'Affiliation': 'Superior School of Physical Education, Federal University of Pelotas, Pelotas, Brazil.'}, {'ForeName': 'César A', 'Initials': 'CA', 'LastName': 'Häfele', 'Affiliation': 'Superior School of Physical Education, Federal University of Pelotas, Pelotas, Brazil.'}, {'ForeName': 'Marcelo C', 'Initials': 'MC', 'LastName': 'da Silva', 'Affiliation': 'Superior School of Physical Education, Federal University of Pelotas, Pelotas, Brazil.'}, {'ForeName': 'Airton J', 'Initials': 'AJ', 'LastName': 'Rombaldi', 'Affiliation': 'Superior School of Physical Education, Federal University of Pelotas, Pelotas, Brazil.'}]",Epilepsia,['10.1111/epi.16588'] 2430,32603006,"Comparison of a 1064-nm neodymium-doped yttrium aluminum garnet picosecond laser using a diffractive optical element vs. a nonablative 1550-nm erbium-glass laser for the treatment of facial acne scarring in Asian patients: a 17-week prospective, randomized, split-face, controlled trial.","BACKGROUND Novel picosecond lasers using a diffractive optical element (P-DOE) have been available for skin resurfacing with distinct mechanisms. However, there are limited data directly comparing P-DOE and conventional fractional lasers for the treatment of atrophic acne scarring. OBJECTIVES We sought to compare the efficacy and safety of a 1064-nm neodymium-doped yttrium aluminium garnet P-DOE and a non-ablative fractional laser (NAFL) in the treatment of acne scarring. METHODS A prospective, randomized, split-face, controlled trial was performed. One randomly assigned half-side of each patient's face (n = 25) was treated with four consecutive sessions of P-DOE at 3-week intervals and the other side with NAFL, with subsequent follow-up for 8 weeks after the final sessions. The efficacy and safety of the two lasers were determined by the Echelle d'Evaluation Clinique des Cicatrices d'acné (Scale of Clinical Evaluation of Acne Scars; ECCA) grading scale, Investigator's Global Assessment (IGA) score and patients' reports at the final visit. Histologic analysis was also performed. RESULTS The P-DOE-treated side achieved a significantly better improvement in acne appearance (ECCA per cent reduction: 55% vs. 42%) with less severe pain (4.3 vs. 5.6) (P < 0.05). The IGA score and subjective satisfaction were consistent with ECCA score results. Occurrences of treatment-related side-effects were also lower in the group treated with P-DOE (P < 0.05). Histologic analysis revealed elongation and increased density of neocollagen fibres, elastic fibres and mucin throughout the dermis from both sides. CONCLUSIONS Compared with NAFL, P-DOE afforded better clinical outcomes and fewer side-effects in the treatment of acne scarring in Asian patients.",2020,"Compared with NAFL, P-DOE afforded better clinical outcomes and fewer side-effects in the treatment of acne scarring in Asian patients.","['Asian patients', 'acne scarring', 'facial acne scarring in Asian patients']","['conventional fractional lasers', 'nonablative 1550-nm erbium-glass laser', '1064-nm neodymium-doped yttrium aluminum garnet picosecond laser', 'NAFL, P-DOE', '1064-nm neodymium-doped yttrium aluminium garnet P-DOE and a non-ablative fractional laser (NAFL']","['Occurrences of treatment-related side-effects', ""Echelle d'Evaluation Clinique des Cicatrices d'acné (Scale of Clinical Evaluation of Acne Scars; ECCA) grading scale, Investigator's Global Assessment (IGA) score"", 'IGA score and subjective satisfaction', 'acne appearance', 'density of neocollagen fibres, elastic fibres and mucin', 'efficacy and safety', 'severe pain']","[{'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001144', 'cui_str': 'Acne vulgaris'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0014688', 'cui_str': 'Erbium'}, {'cui': 'C0015421', 'cui_str': 'Eyeglasses'}, {'cui': 'C0027599', 'cui_str': 'Neodymium'}, {'cui': 'C0013039', 'cui_str': 'Doping in Sports'}, {'cui': 'C1609285', 'cui_str': 'yttrium-aluminum-garnet'}, {'cui': 'C1532556', 'cui_str': 'Picosecond pulsed laser device'}, {'cui': 'C0013879', 'cui_str': 'Chemical element'}, {'cui': 'C0043432', 'cui_str': 'Yttrium'}, {'cui': 'C0002367', 'cui_str': 'Aluminum'}]","[{'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0011702', 'cui_str': '4-(4-Amino-4-Carboxybutyl)-1-(5-Amino-5-Carboxypentyl)-3,5-bis(3-Amino-3-Carboxypropyl)pyridinium'}, {'cui': 'C0241158', 'cui_str': 'Scar of skin'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1261322', 'cui_str': 'Evaluation procedure'}, {'cui': 'C0423783', 'cui_str': 'Acne scar'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C4758616', 'cui_str': 'Assessment score'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0001144', 'cui_str': 'Acne vulgaris'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0225326', 'cui_str': 'Fiber'}, {'cui': 'C0230899', 'cui_str': 'Elastic fiber'}, {'cui': 'C0026682', 'cui_str': 'Mucins'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0278140', 'cui_str': 'Severe pain'}]",1.0,0.0302493,"Compared with NAFL, P-DOE afforded better clinical outcomes and fewer side-effects in the treatment of acne scarring in Asian patients.","[{'ForeName': 'H H', 'Initials': 'HH', 'LastName': 'Kwon', 'Affiliation': 'Oaro Dermatology Clinic, Seoul, Korea.'}, {'ForeName': 'S H', 'Initials': 'SH', 'LastName': 'Yang', 'Affiliation': 'Department of Dermatology, Johns Hopkins University School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Y J', 'Initials': 'YJ', 'LastName': 'Cho', 'Affiliation': 'Oaro Dermatology Clinic, Seoul, Korea.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Shin', 'Affiliation': 'Department of Pathology, Dongtan Sacred Heart Hospital, Hallym University College of Medicine, Hwaseong, Korea.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Choi', 'Affiliation': 'Department of Dermatology, Ilsan Paik Hospital, Inje University College of Medicine, Goyang, Korea.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Bae', 'Affiliation': 'Department of Dermatology, Dongtan Sacred Heart Hospital, Hallym University College of Medicine, Hwaseong, Korea.'}, {'ForeName': 'J Y', 'Initials': 'JY', 'LastName': 'Jung', 'Affiliation': 'Oaro Dermatology Clinic, Seoul, Korea.'}, {'ForeName': 'G-H', 'Initials': 'GH', 'LastName': 'Park', 'Affiliation': 'Department of Dermatology, Dongtan Sacred Heart Hospital, Hallym University College of Medicine, Hwaseong, Korea.'}]",Journal of the European Academy of Dermatology and Venereology : JEADV,['10.1111/jdv.16643'] 2431,32598165,"Maternal Infant-Feeding Attitudes, Infant Eating Behaviors, and Maternal Feeding Choice at 3 and 6 Months Postpartum: A Comparative Multicenter International Study.","Objective: The aim of this study was to compare mothers' attitudes toward infant feeding and infant eating behavior in different countries, and their associations with infant feeding at 3 and 6 months. Methods: Data from 164 mothers with healthy term infants recruited for a randomized trial comparing breast pumps from the UK ( n  = 68), Russia ( n  = 51), and China ( n  = 45) were included in this analysis. Feeding practices were assessed using questionnaires at 3 and 6 months. Maternal attitudes toward infant feeding and infant eating behaviors were measured by Iowa Infant Feeding Attitudes Scale (IIFAS) and Baby Eating Behavior Questionnaire (BEBQ) at 5-6 weeks postpartum; scores were compared between countries and associations with infant feeding at 3 and 6 months were examined. Results: IIFAS score was significantly different between countries; mean scores in Chinese and Russian mothers (China 64.6 ± 4.88 and Russia 61.5 ± 6.15) lay in the range of ""neutral breastfeeding attitudes,"" while British mothers had more positive attitudes (70.6 ± 6.47, post hoc p  < 0.001). Russian infants had higher scores for ""general appetite"" (mean = 4.8 ± 0.41, p  < 0.05) and ""satiety responsiveness"" (mean = 8.7 ± 1.08, p  < 0.01) than Chinese or British infants. Longer duration of full-time education was associated with more positive attitudes toward breastfeeding in the whole sample ( p  < 0.001) and in the United Kingdom ( p  < 0.05). The majority of mothers were exclusively breastfeeding (EBF) at 3 months. Total IIFAS and BEBQ scores were not significant predictors of EBF at 3 and 6 months ( p  > 0.05), although greater agreement with the IIFAS statement ""Formula feeding is more convenient than breastfeeding"" was associated with lower EBF at 3 months (OR = 0.47, 95% CI: 0.29-0.78, p  < 0.01). Conclusions: Maternal attitudes toward infant feeding and perceptions of infant eating behavior differed between countries, but were not associated with EBF at 6 months. Mothers with a greater baseline perception that formula feeding is more convenient than breastfeeding were less likely to EBF at 3 months; this could be a potential target for education.",2020,"Total IIFAS and BEBQ scores were not significant predictors of EBF at 3 and 6 months ( p  > 0.05), although greater agreement with the IIFAS statement ""Formula feeding is more convenient than breastfeeding"" was associated with lower EBF at 3 months (OR = 0.47, 95% CI: 0.29-0.78, p  < 0.01). ","['164 mothers with healthy term infants recruited for a randomized trial comparing breast pumps from the UK ( n \u2009=\u200968), Russia ( n \u2009=\u200951), and China ( n \u2009=\u200945', ""mothers' attitudes toward infant feeding and infant eating behavior in different countries, and their associations with infant feeding at 3 and 6 months""]",[],"['Iowa Infant Feeding Attitudes Scale (IIFAS) and Baby Eating Behavior Questionnaire (BEBQ', 'Longer duration of full-time education', 'positive attitudes toward breastfeeding', 'Maternal Infant-Feeding Attitudes, Infant Eating Behaviors, and Maternal Feeding Choice', 'satiety responsiveness', 'IIFAS score', 'positive attitudes', 'Maternal attitudes toward infant feeding and infant eating behaviors', 'general appetite', 'Total IIFAS and BEBQ scores', 'Maternal attitudes toward infant feeding and perceptions of infant eating behavior']","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0456128', 'cui_str': 'Term infant'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0182541', 'cui_str': 'Breast pump'}, {'cui': 'C0035970', 'cui_str': 'Russian federation - Europe'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0015745', 'cui_str': 'Eating Behavior'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0204695', 'cui_str': 'Feeding patient'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]",[],"[{'cui': 'C0022037', 'cui_str': 'Iowa'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0204695', 'cui_str': 'Feeding patient'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0015745', 'cui_str': 'Eating Behavior'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439591', 'cui_str': 'Long duration'}, {'cui': 'C0682295', 'cui_str': 'Full-time employment'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0237428', 'cui_str': 'Positive attitude'}, {'cui': 'C0006147', 'cui_str': 'Breast fed'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C0036239', 'cui_str': 'Satiety'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030971', 'cui_str': 'Perception'}]",164.0,0.0418655,"Total IIFAS and BEBQ scores were not significant predictors of EBF at 3 and 6 months ( p  > 0.05), although greater agreement with the IIFAS statement ""Formula feeding is more convenient than breastfeeding"" was associated with lower EBF at 3 months (OR = 0.47, 95% CI: 0.29-0.78, p  < 0.01). ","[{'ForeName': 'Jinyue', 'Initials': 'J', 'LastName': 'Yu', 'Affiliation': 'Childhood Nutrition Research, Population Policy and Practice Research and Teaching Department, UCL Great Ormond Street Institute of Child Health, London, United Kingdom.'}, {'ForeName': 'Zhuang', 'Initials': 'Z', 'LastName': 'Wei', 'Affiliation': ""Beijing Children's Hospital Affiliated to Capital Medical University, Beijing, China.""}, {'ForeName': 'Olga', 'Initials': 'O', 'LastName': 'Lukoyanova', 'Affiliation': 'Department of Nutrition for Sick and Healthy Children, ""National Medical Research Center of Children\'s Health"" of the Ministry of Health of the Russian Federation, Moscow, Russia.'}, {'ForeName': 'Tatyana', 'Initials': 'T', 'LastName': 'Borovik', 'Affiliation': 'Department of Nutrition for Sick and Healthy Children, ""National Medical Research Center of Children\'s Health"" of the Ministry of Health of the Russian Federation, Moscow, Russia.'}, {'ForeName': 'Mary S', 'Initials': 'MS', 'LastName': 'Fewtrell', 'Affiliation': 'Childhood Nutrition Research, Population Policy and Practice Research and Teaching Department, UCL Great Ormond Street Institute of Child Health, London, United Kingdom.'}]",Breastfeeding medicine : the official journal of the Academy of Breastfeeding Medicine,['10.1089/bfm.2020.0066'] 2432,32598447,Effects of Prophylactic Lipofilling After Radiotherapy Compared to Non-Fat Injected Breasts: A Randomized Objective Study.,"BACKGROUND Patients who suffering by invasive breast cancer may require post-mastectomy radiation therapy (PMRT). PMRT improves outcomes in breast cancer patients in terms of locoregional recurrence. Preliminary studies indicate that fat injections reduce post-radiation damage of soft tissue and implants. OBJECTIVE The aim of this study was to demonstrate the safety and effectiveness of prophylactic fat injections on radiated implanted breasts. METHODS Sixty female patients were randomly assigned to group A or B. Group A patients received three breast fat injections, according to Coleman's technique, after radiotherapy and before expander removal with definitive implant insertion. Group B patients underwent surgery without lipofilling. At each surgical operation, skin biopsies were performed in a specific breast area to evaluate adipose tissue thickness, and statistical analysis of its variations was performed with the Wilcoxon's sum test. Disability was assessed according to the LENT-SOMA scale. RESULTS Our study demonstrates a qualitative and quantitative improvement about tissues after fat injection. This is highlighted by the significant increase in thickness after lipofilling. CONCLUSIONS Our study, which is based on both clinical and histological findings and is supported by the comparison of a control group with a 1-year follow-up, demonstrates that fat injections reduce tissue radio-damage, improving reconstructive surgery outcomes and quality of life.",2020,PMRT improves outcomes in breast cancer patients in terms of locoregional recurrence.,"['breast cancer patients', 'Patients who suffering by invasive breast cancer', 'Sixty female patients']","[""three breast fat injections, according to Coleman's technique, after radiotherapy and before expander removal with definitive implant insertion"", 'Prophylactic Lipofilling', 'prophylactic fat injections', 'mastectomy radiation therapy (PMRT', 'surgery without lipofilling', 'PMRT', 'Radiotherapy']","['safety and effectiveness', 'Disability', 'locoregional recurrence', 'reconstructive surgery outcomes and quality of life']","[{'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0853879', 'cui_str': 'Invasive carcinoma of breast'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0443196', 'cui_str': 'Definitive'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0009653', 'cui_str': 'Condom'}, {'cui': 'C0024881', 'cui_str': 'Mastectomy'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0524865', 'cui_str': 'Reconstruction - action'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",60.0,0.0221428,PMRT improves outcomes in breast cancer patients in terms of locoregional recurrence.,"[{'ForeName': 'Marika', 'Initials': 'M', 'LastName': 'Gentilucci', 'Affiliation': 'Department of Plastic Surgery, University of Perugia, San Sisto Perugia, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Mazzocchi', 'Affiliation': 'Department of Plastic Surgery, University of Perugia, San Sisto Perugia, Italy.'}, {'ForeName': 'Carmine', 'Initials': 'C', 'LastName': 'Alfano', 'Affiliation': 'Department of Plastic Surgery, University of Perugia, San Sisto Perugia, Italy.'}]",Aesthetic surgery journal,['10.1093/asj/sjaa182'] 2433,32598468,Electronically Monitored Nicotine Gum Use Before and After Smoking Lapses: Relations with Lapse and Relapse.,"INTRODUCTION Greater use of nicotine replacement therapy (NRT) is related to smoking cessation success but the causal direction is unclear. This study characterized relations between NRT use and smoking lapse and relapse. METHODS Participants (N=416 smokers; 57% female, 85% White) were recruited from primary care for a smoking cessation factorial experiment and analyzed if abstaining ≥1 day in the first 2 weeks post-target quit day (TQD). Participants were randomized to counseling and 8 versus 26 weeks of nicotine patch plus nicotine gum post-TQD. Participants carried electronic dispensers that time-stamped each gum use. Participants who lapsed (smoked after abstaining) within 6 weeks post-TQD were matched with non-lapsers (n=146 pairs) on multiple variables. We compared lapsers' versus matched non-lapsers' gum use in the 5 days before and after the lapsers' first lapse. RESULTS By week 6 post-TQD, 63% of participants lapsed. Compared to non-lapsers, lapsers used less gum 1 and 2 days pre-""lapse"" and on the 5 post-lapse days. Lapsers used less gum during the 5 days post-lapse than the 5 days pre-lapse. Univariate survival analyses with lapsers showed greater gum use during both pre- and post-lapse periods predicted longer latency to relapse in the first 6 weeks. CONCLUSIONS In a smoking cessation attempt using nicotine patch plus gum, lapsers versus matched non-lapsers used less gum immediately preceding and following their first lapse. Lower mean gum use before and after lapses predicted a more rapid escalation to relapse. Decreased nicotine gum use both precedes and follows returns to smoking during cessation attempts.",2020,"In a smoking cessation attempt using nicotine patch plus gum, lapsers versus matched non-lapsers used less gum immediately preceding and following their first lapse.","['Participants who lapsed (smoked after abstaining) within 6 weeks post-TQD were matched with non-lapsers (n=146 pairs) on multiple variables', 'Participants (N=416 smokers; 57% female, 85% White) were recruited from primary care for a smoking cessation factorial experiment and analyzed if abstaining ≥1 day in the first 2 weeks post-target quit day (TQD']","['nicotine replacement therapy (NRT', 'nicotine patch plus nicotine gum post-TQD', 'nicotine patch plus gum, lapsers versus matched non-lapsers']",['Univariate survival analyses'],"[{'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0085134', 'cui_str': 'Stopping Smoking'}]","[{'cui': 'C1278444', 'cui_str': 'Nicotine replacement therapy'}, {'cui': 'C0358855', 'cui_str': 'Nicotine Transdermal Patch'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0599654', 'cui_str': 'Nicotine Chewing Gum'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0017562', 'cui_str': 'Gingival structure'}, {'cui': 'C0336766', 'cui_str': 'Matches'}]","[{'cui': 'C0038953', 'cui_str': 'Analysis, Survival'}]",416.0,0.00852757,"In a smoking cessation attempt using nicotine patch plus gum, lapsers versus matched non-lapsers used less gum immediately preceding and following their first lapse.","[{'ForeName': 'Tanya R', 'Initials': 'TR', 'LastName': 'Schlam', 'Affiliation': 'Center for Tobacco Research and Intervention, University of Wisconsin School of Medicine and Public Health.'}, {'ForeName': 'Timothy B', 'Initials': 'TB', 'LastName': 'Baker', 'Affiliation': 'Center for Tobacco Research and Intervention, University of Wisconsin School of Medicine and Public Health.'}, {'ForeName': 'Stevens S', 'Initials': 'SS', 'LastName': 'Smith', 'Affiliation': 'Center for Tobacco Research and Intervention, University of Wisconsin School of Medicine and Public Health.'}, {'ForeName': 'Daniel M', 'Initials': 'DM', 'LastName': 'Bolt', 'Affiliation': 'Department of Educational Psychology, University of Wisconsin-Madison.'}, {'ForeName': 'Danielle E', 'Initials': 'DE', 'LastName': 'McCarthy', 'Affiliation': 'Center for Tobacco Research and Intervention, University of Wisconsin School of Medicine and Public Health.'}, {'ForeName': 'Jessica W', 'Initials': 'JW', 'LastName': 'Cook', 'Affiliation': 'Center for Tobacco Research and Intervention, University of Wisconsin School of Medicine and Public Health.'}, {'ForeName': 'Todd', 'Initials': 'T', 'LastName': 'Hayes-Birchler', 'Affiliation': 'Center for Tobacco Research and Intervention, University of Wisconsin School of Medicine and Public Health.'}, {'ForeName': 'Michael C', 'Initials': 'MC', 'LastName': 'Fiore', 'Affiliation': 'Center for Tobacco Research and Intervention, University of Wisconsin School of Medicine and Public Health.'}, {'ForeName': 'Megan E', 'Initials': 'ME', 'LastName': 'Piper', 'Affiliation': 'Center for Tobacco Research and Intervention, University of Wisconsin School of Medicine and Public Health.'}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/ntaa116'] 2434,32598472,"Randomised control trial of compression interventions for managing hand burn edema, as measured by bioimpedance spectroscopy.","INTRODUCTION Compression, a common treatment of choice for the management of edema, is one intervention which is applied with little objective understanding of the optimal parameters of application or efficacy in acute burn wounds. AIM The aim of this study was to determine the effectiveness of different methods of compression for the management of hand edema following burn injury. The primary hypothesis tested was: in acute hand burn injury, application of cohesive bandage will reduce edema faster than a generic compression glove. METHODS A randomized control study of 100 patients presenting with hand burn injury. Compression was randomized to one of three methods of application - 1) spiral application of Coban to fingers, figure of eight to hand and wrist; 2) pinch application of Coban to fingers, spiral application to hand and wrist; or 3) a generic compression glove (control condition). Bioimpedance spectroscopy (BIS) was used to measure hand volumes. Hand and wrist range of movement, pain scores and QuickDASH were recorded. RESULTS One hundred patients (68 males) demonstrated significant reductions in hand volumes, using all compression methods. Both methods of applying Coban resulted in significantly greater reductions in edema compared to the generic compression glove. Notwithstanding compression method, all ROM measures improved, with significant improvement in thumb opposition (p=0.046), hand span (p=0.020) and wrist flexion (p=0.020). QuickDASH decreased between sessions (p<0.001). CONCLUSION Different methods of applying Coban are superior to generic compression gloves for managing acute hand burn edema.",2020,"Notwithstanding compression method, all ROM measures improved, with significant improvement in thumb opposition (p=0.046), hand span (p=0.020) and wrist flexion (p=0.020).","['100 patients presenting with hand burn injury', 'hand edema following burn injury']","['generic compression glove (control condition', 'compression interventions']","['edema', 'ROM measures', 'Hand and wrist range of movement, pain scores and QuickDASH', 'hand span (p=0.020) and wrist flexion', 'thumb opposition', 'QuickDASH', 'Bioimpedance spectroscopy (BIS']","[{'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0274089', 'cui_str': 'Burn of hand'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0239819', 'cui_str': 'Edema of hand'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0006434', 'cui_str': 'Burn injury'}]","[{'cui': 'C0085155', 'cui_str': 'Generic Drugs'}, {'cui': 'C3880512', 'cui_str': 'Compression glove'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0013604', 'cui_str': 'Edema'}, {'cui': 'C0948106', 'cui_str': 'Amniorrhexis'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0043262', 'cui_str': 'Wrist region structure'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0231452', 'cui_str': 'Flexion'}, {'cui': 'C0427082', 'cui_str': 'Opposition of thumb'}, {'cui': 'C0037812', 'cui_str': 'Analysis, Spectrum'}, {'cui': 'C0053723', 'cui_str': 'bis(cyclohexylammonium)'}]",100.0,0.0418211,"Notwithstanding compression method, all ROM measures improved, with significant improvement in thumb opposition (p=0.046), hand span (p=0.020) and wrist flexion (p=0.020).","[{'ForeName': 'Dale O', 'Initials': 'DO', 'LastName': 'Edwick', 'Affiliation': 'State Adult Burns Unit, Fiona Stanley Hospital, Murdoch, Western Australia.'}, {'ForeName': 'Dana A', 'Initials': 'DA', 'LastName': 'Hince', 'Affiliation': 'Institute of Health Research, The University of Notre Dame Australia, Fremantle, Western Australia.'}, {'ForeName': 'Jeremy M', 'Initials': 'JM', 'LastName': 'Rawlins', 'Affiliation': 'State Adult Burns Unit, Fiona Stanley Hospital, Murdoch, Western Australia.'}, {'ForeName': 'Fiona M', 'Initials': 'FM', 'LastName': 'Wood', 'Affiliation': 'State Adult Burns Unit, Fiona Stanley Hospital, Murdoch, Western Australia.'}, {'ForeName': 'Dale W', 'Initials': 'DW', 'LastName': 'Edgar', 'Affiliation': 'State Adult Burns Unit, Fiona Stanley Hospital, Murdoch, Western Australia.'}]",Journal of burn care & research : official publication of the American Burn Association,['10.1093/jbcr/iraa104'] 2435,32598629,[Glycemia normalization in patients with obesity and type 2 diabetes mellitus: bariatric surgery vs pharmacological therapy].,"AIMS To compare glucose - lowering and weight reduction capacity of bypass operations (gastric bypass (GB), biliopancreatic diversion (BPD) vs GLP-1 agonist liraglutide 3.0 mg (models of maximum incretin effect) for 6 months. MATERIALS AND METHODS 46 patients with type 2 diabetes and long history (≥10 years) of obesity were divided into 2 groups: surgery - group (n=23) and liraglutide - group (n=23), where liraglutide 3.0 mg in dose - escalation manner was added to baseline glucose - lowering therapy. Anthropometric parameters, HbA1c and insulin resistance (IR) by hyperinsulinemic euglycemic clamp (M-value) were measured before and 16 weeks after the intervention. With the stabilization of glycemia (≤6.5 mmol/l at fasting state, ≤8 mmol/l postprandial) the initial glucose - lowering therapy was canceled. RESULTS AND DISCUSSION Both surgery and liraglutide 3.0 mg provided target HbA1c in 16 weeks. Bypass operations led to elimination of glucose - lowering therapy in 82.6% patients due to a more significant weight reduction and decrease in IR. In liraglutide - group previous glucose - lowering therapy was cancelled in 78.3% patients, mainly receiving baseline mono - and two - component therapy. The most significant difference between interventions was achieved in BMI (-8.9 kg in surgery group vs -3.8 kg in liraglutide group, p.",2019,Bypass operations led to elimination of glucose - lowering therapy in 82.6% patients due to a more significant weight reduction and decrease in IR.,"['patients with obesity and type 2 diabetes mellitus', '46 patients with type 2 diabetes and long history (≥10 years) of obesity']","['liraglutide - group', 'liraglutide - group previous glucose - lowering therapy', 'liraglutide 3.0 mg in dose - escalation manner was added to baseline glucose - lowering therapy', 'liraglutide', 'GLP-1 agonist liraglutide', 'bypass operations (gastric bypass (GB), biliopancreatic diversion (BPD']","['Anthropometric parameters, HbA1c and insulin resistance (IR) by hyperinsulinemic euglycemic clamp (M-value', 'BMI', 'IR']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0019664', 'cui_str': 'History'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0441994', 'cui_str': 'Lower'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-like peptide 1'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0741847', 'cui_str': 'Bypass'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0017125', 'cui_str': 'Bypass of stomach'}, {'cui': 'C0005435', 'cui_str': 'Biliopancreatic bypass'}, {'cui': 'C0006012', 'cui_str': 'Borderline personality disorder'}]","[{'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0079318', 'cui_str': 'Euglycaemic Clamp'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]",46.0,0.0154823,Bypass operations led to elimination of glucose - lowering therapy in 82.6% patients due to a more significant weight reduction and decrease in IR.,"[{'ForeName': 'I A', 'Initials': 'IA', 'LastName': 'Sklyanik', 'Affiliation': 'Endocrinology Research Centre.'}, {'ForeName': 'E A', 'Initials': 'EA', 'LastName': 'Shestakova', 'Affiliation': 'Endocrinology Research Centre.'}, {'ForeName': 'A V', 'Initials': 'AV', 'LastName': 'Yurasov', 'Affiliation': 'Central Clinical Hospital No. 1 of Russian Railways.'}, {'ForeName': 'Y I', 'Initials': 'YI', 'LastName': 'Yashkov', 'Affiliation': 'Center of Endosurgery and Lithotripsy.'}, {'ForeName': 'M V', 'Initials': 'MV', 'LastName': 'Shestakova', 'Affiliation': 'Endocrinology Research Centre.'}]",Terapevticheskii arkhiv,['10.26442/00403660.2019.10.000375'] 2436,32598699,[Clinical efficacy of mechanical bacterial lysate in the prevention of infectious exacerbations of chronic obstructive pulmonary disease].,"AIM To evaluate the efficacy of mechanical bacterial lysate on the prevention of infectious exacerbations of chronic obstructive pulmonary disease in patients with frequent exacerbations. MATERIALS AND METHODS The study included patients (n=60) with frequent exacerbations of COPD (groups C and D according to the GOLD classification). All COPD patients were divided into two groups by blind method. The first group (n=30) received conventional therapy for COPD plus MBL (the course included 3 cycles of 10 days therapy with 20-day intervals between them). The second group of patients (control, n=30) received conventional therapy for COPD without MBL.We evaluated the severity of symptoms, frequency of recurrence of COPD exacerbations, readmissions, need for emergency care and changes in basic therapy of COPD. Evaluations were done on 10 days, 1, 3 and 6 months from the start of the study. RESULTS Adding of MBL to the therapy list of COPD resulted in a significant decrease of biomarkers of systemic inflammation and sputum purulence during compared to the control group. After 6 months of observation MBL group demonstrated statistically significant improvement of respiratory function, decrease in frequency of COPD exacerbations, needs for emergency medical service, reduced changes in basic therapy and hospitalization for exacerbation of COPD. Therapy with MBL showed a high degree of safety and low incidence of adverse events. CONCLUSION The results of the study indicate that MBL may be used for the prevention of severe infectious exacerbations of COPD.",2020,"After 6 months of observation MBL group demonstrated statistically significant improvement of respiratory function, decrease in frequency of COPD exacerbations, needs for emergency medical service, reduced changes in basic therapy and hospitalization for exacerbation of COPD.","['chronic obstructive pulmonary disease', 'All COPD patients', 'patients (n=60) with frequent exacerbations of COPD (groups C and D according to the GOLD classification', 'patients with frequent exacerbations']","['MBL', 'conventional therapy for COPD plus MBL', 'conventional therapy for COPD without MBL.We', 'mechanical bacterial lysate']","['chronic obstructive pulmonary disease', 'respiratory function', 'frequency of COPD exacerbations, needs for emergency medical service, reduced changes in basic therapy and hospitalization for exacerbation of COPD', 'severity of symptoms, frequency of recurrence of COPD exacerbations, readmissions, need for emergency care and changes in basic therapy of COPD', 'biomarkers of systemic inflammation and sputum purulence']","[{'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332183', 'cui_str': 'Frequent'}, {'cui': 'C0441837', 'cui_str': 'Group C'}, {'cui': 'C0018026', 'cui_str': 'Gold'}, {'cui': 'C0008902', 'cui_str': 'Classification'}]","[{'cui': 'C0065661', 'cui_str': 'Mannose-binding protein'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C1569170', 'cui_str': 'polyvalent mechanical bacterial lysate'}]","[{'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0740304', 'cui_str': 'COPD exacerbation'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0013961', 'cui_str': 'Emergency medical services'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0038056', 'cui_str': 'Sputum'}, {'cui': 'C0854358', 'cui_str': 'Purulence'}]",60.0,0.0349951,"After 6 months of observation MBL group demonstrated statistically significant improvement of respiratory function, decrease in frequency of COPD exacerbations, needs for emergency medical service, reduced changes in basic therapy and hospitalization for exacerbation of COPD.","[{'ForeName': 'S N', 'Initials': 'SN', 'LastName': 'Avdeev', 'Affiliation': 'Sechenov First Moscow State Medical University (Sechenov University).'}, {'ForeName': 'G S', 'Initials': 'GS', 'LastName': 'Nuralieva', 'Affiliation': 'Sechenov First Moscow State Medical University (Sechenov University).'}, {'ForeName': 'V V', 'Initials': 'VV', 'LastName': 'Gainitdinova', 'Affiliation': 'Sechenov First Moscow State Medical University (Sechenov University).'}, {'ForeName': 'G E', 'Initials': 'GE', 'LastName': 'Baimakanova', 'Affiliation': 'Loginov Moscow Clinical Scientific Center.'}, {'ForeName': 'A K', 'Initials': 'AK', 'LastName': 'So', 'Affiliation': 'Military Medical Academy.'}, {'ForeName': 'Z M', 'Initials': 'ZM', 'LastName': 'Merzhoeva', 'Affiliation': 'Sechenov First Moscow State Medical University (Sechenov University).'}]",Terapevticheskii arkhiv,['10.26442/00403660.2020.04.000590'] 2437,32598700,[Comparison of clinical-metabolic efficacy of pre- and probiotics in the conducted optimized protocols of eradication therapy of Helicobacter pylori infection].,"Low patient compliance due to the development of adverse events in the form of antibiotic-associated diarrhea (AAD) is considered as the main reason for the failure of the eradication of optimized anti-Helicobacter therapy regimens. A key mechanism for the development of AAD is to reduce the number and species diversity of bacteria that form butyric acid. AIM The purpose of this study was to study the comparative effect on the clinical effectiveness of eradication therapy (ET) of Helicobacter pylori infection and metabolic changes in the colon microbiota of additional inclusion in the optimized treatment regimen of the combined prebiotic Zakofalk (inulin + butyrate) with probiotics (lacto- and bifidobacteria in an amount of at least 1017 СFU). MATERIALS AND METHODS 120 patients with chronic gastroduodenal diseases and infected H. pylori were еxamined. A comparative analysis of the effect of a combined prebiotic and lacto-bifid-containing probiotics on improving the effectiveness of the optimized ET scheme and improving its tolerability, as well as on the quantitative and qualitative content of short-chain fatty acids (SFA) in feces. The success of eradication was controlled by a 13C urease breath test. RESULTS According to the results of the study in randomized groups of patients, an excellent percentage of eradication (95%) was achieved in patients who performed ET with the addition of the prebiotic Zakofalk. In the same group of patients, there was an increase in the absolute content of SFA and a significant increase in the concentration of butyric acid. In the group of patients who received ET with the addition of probiotics, an acceptable level of eradication was achieved (85.7%), but no changes in SFA were found indicating an increase in the number or activity of the butyrate-producing flora. Patients who performed ET without the addition of pre-probiotics did not achieve the target percentage of successful eradication (83.3%), and a significant quantitative decrease in SFA was found with a significant decrease in the proportion of butyric acid. CONCLUSION The inclusion of Zakofalk in the ET scheme, in comparison with probiotics, significantly increases the probability of successful eradication, more effectively restores the metabolic potential of the microbiota, and prevents the development of AAD.",2020,"In the same group of patients, there was an increase in the absolute content of SFA and a significant increase in the concentration of butyric acid.","['120 patients with chronic gastroduodenal diseases and infected H. pylori were еxamined', 'Helicobacter pylori infection']","['combined prebiotic and lacto-bifid-containing probiotics', 'pre- and probiotics', 'eradication therapy (ET', 'combined prebiotic Zakofalk (inulin + butyrate) with probiotics (lacto- and bifidobacteria']","['acceptable level of eradication', 'number or activity of the butyrate-producing flora', 'probability of successful eradication', 'successful eradication', 'concentration of butyric acid', 'absolute content of SFA', 'proportion of butyric acid', 'success of eradication']","[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0450199', 'cui_str': 'Gastroduodenal'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0079488', 'cui_str': 'Helicobacter pylori'}, {'cui': 'C0850666', 'cui_str': 'Infection caused by Helicobacter pylori'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C2717875', 'cui_str': 'Prebiotics'}, {'cui': 'C0443152', 'cui_str': 'Bifid'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0021936', 'cui_str': 'Inulin'}, {'cui': 'C0006521', 'cui_str': 'Butyrates'}]","[{'cui': 'C3539083', 'cui_str': 'Acceptable'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0006521', 'cui_str': 'Butyrates'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0006523', 'cui_str': 'Butanoic Acids'}, {'cui': 'C0205344', 'cui_str': 'Absolute'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0015691', 'cui_str': 'Short chain fatty acid'}]",120.0,0.0258875,"In the same group of patients, there was an increase in the absolute content of SFA and a significant increase in the concentration of butyric acid.","[{'ForeName': 'L I', 'Initials': 'LI', 'LastName': 'Butorova', 'Affiliation': 'Sechenov First Moscow State Medical University (Sechenov University).'}, {'ForeName': 'M D', 'Initials': 'MD', 'LastName': 'Ardatskaya', 'Affiliation': 'Central State Medical Academy of the President of the Russian Federation.'}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Osadchuk', 'Affiliation': 'Sechenov First Moscow State Medical University (Sechenov University).'}, {'ForeName': 'N G', 'Initials': 'NG', 'LastName': 'Kadnikova', 'Affiliation': 'Central Clinical Hospital for Rehabilitation Treatment.'}, {'ForeName': 'E I', 'Initials': 'EI', 'LastName': 'Lukianova', 'Affiliation': 'City Polyclinic №201.'}, {'ForeName': 'R G', 'Initials': 'RG', 'LastName': 'Plavnik', 'Affiliation': 'ISOCARB LLC.'}, {'ForeName': 'E V', 'Initials': 'EV', 'LastName': 'Sayutina', 'Affiliation': 'Sechenov First Moscow State Medical University (Sechenov University).'}, {'ForeName': 'T B', 'Initials': 'TB', 'LastName': 'Topchiy', 'Affiliation': 'Central State Medical Academy of the President of the Russian Federation.'}, {'ForeName': 'E M', 'Initials': 'EM', 'LastName': 'Tuayeva', 'Affiliation': 'Sechenov First Moscow State Medical University (Sechenov University).'}]",Terapevticheskii arkhiv,['10.26442/00403660.2020.04.000647'] 2438,32598735,"[Risk - adapted intensive induction therapy, autologous stem cell transplantation, and rituximab maintenance allow to reach a high 7-year survival rate in patients with mantle cell lymphoma].","Mantle cell lymphoma (MCL) is aggressive B-cell neoplasm diagnosed predominantly among older men. R-CHOP-like regimens allow to achieve high response rate, but the overall survival (OS) are disappointingly short - 3-4 years. An addition of high - dose cytarabine to the upfront therapy and autoSCT significantly improved outcomes but remain feasible largely for medically fit patients. Based on the activity and good tolerance of gemcitabine - oxaliplatin schemes in relapsed and refractory MCL patients, we developed an alternative first - line course for patients who are not eligible for R-HD-MTX-AraC. AIM Assess toxicity and efficacy of R-DA-EPOCH/ R-HD-MTX-AraC and R-DA-EPOCH/R-GIDIOX schemes, autoSCT and R-maintenance in untreated MCL patients. MATERIALS AND METHODS 47 untreated MCL patients from 6 centers were enrolled in prospective study between April 2008 and September 2013. All patients have stage II-V; ECOG 0-3; median age 55 years (29-64); Male/Female 76%/24%. MIPIb: 28% low, 33% intermediate and 39% high risk. Following 1st R-EPOCH patients were assigned to receive either R-DA-EPOCH/ R-HD-MTX-AraC or R-DA-EPOCH/ R-GIDIOX regimen. In the absence of renal failure, hematological toxicity grade 4 more than 3 days and severe infections patients received R-HD-MTX-AraC scheme (R 375 mg/m2 Day 0, Methotrexate 1000 mg/m2/24 hours Day 1, AraC 3000 mg/m2 q 12 hrs Days 2-3). Patients who had at least one of these complications received R-GIDIOX scheme (R 375 mg/m2 day 0, gemcitabine 800 mg/m2 days 1 and 4, ifosfamide 1000 mg/m2 days 1-5, dexamethasone 10 mg/m2 IV days 1-5, irinotecan 100 mg/m2 day 3, oxaliplatin 120 mg/m2 day 2). Subsequently these courses were alternating with R-DA-EPOCH in each arm of the protocol. Depending on the time of achieving CR patients received 6 or 8 courses, unless they progressed on therapy. Those patients who achieved PR/CR/CRu underwent autoSCT (BEAM-R). Post - transplant R-maintenance was administered for 3 years (R - 375 mg/m2 every 3 months). RESULTS 29/47 patients were treated on R-HD-MTX-AraC arm (median 50 years; MIPIb: 35.7% low, 28.6% intermediate, 35.7% high risk) and 18/47 patients were on R-GIDIOX arm (median 60 years; MIPIb: 16.7% low, 38.9% intermediate, 44.4% high risk). In R-HD-MTX-AraC arm CR rate was 96.5%. In R-GIDIOX arm OR and CR rates were 94.4% and 77.7% respectively. Main hematological toxicity of R-GIDIOX was leukopenia gr. 4 occurred in 74.1%. With median follow - up of 76 months, the estimated 7-years OS and EFS in R-HD-MTX-AraC arm are 76% and 57% respectively. In R-GIDIOX arm the estimated 7-years OS and EFS are 59% and 44%, respectively. There are no statistical differences in EFS (p=0.47) and OS (p=0.06) between two arms. CONCLUSIONS The use of a risk - adapted strategy allowed 95.7% of patients achieve PR/CR/CRu, performed autoSCT and begun R-maintenance therapy with rituximab. None of the patients needed a premature discontinuation of therapy because of unacceptable toxicity. The performance of autoSCT and R-maintenance apparently allowed to partially offset differences in the intensity of induction therapy and to maintain comparable results of therapy in both induction arms.",2019,"There are no statistical differences in EFS (p=0.47) and OS (p=0.06) between two arms. ","['patients with mantle cell lymphoma', '47 untreated MCL patients from 6 centers were enrolled in prospective study between April 2008 and September 2013', 'All patients have stage II-V; ECOG 0-3; median age 55 years (29-64); Male/Female 76%/24', 'relapsed and refractory MCL patients']","['cytarabine', 'gemcitabine - oxaliplatin', 'Risk - adapted intensive induction therapy, autologous stem cell transplantation, and rituximab maintenance', 'ifosfamide 1000 mg/m2 days 1-5, dexamethasone 10 mg/m2 IV days 1-5, irinotecan 100 mg/m2 day 3, oxaliplatin', 'R-DA-EPOCH/ R-HD-MTX-AraC or R-DA-EPOCH/ R-GIDIOX regimen', 'gemcitabine', 'rituximab', 'Methotrexate']","['CR rates', 'EFS', 'CR rate', '7-year survival rate', 'overall survival (OS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0334634', 'cui_str': 'Mantle cell lymphoma'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0033522', 'cui_str': 'Prospective Studies'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2'}, {'cui': 'C0430797', 'cui_str': 'Electrocorticogram'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0855138', 'cui_str': 'Mantle cell lymphoma refractory'}]","[{'cui': 'C0010711', 'cui_str': 'Cytarabine'}, {'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C1831743', 'cui_str': 'Transplantation of autologous hematopoietic stem cell'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C4238558', 'cui_str': 'Ifosfamide 1000 MG [Ifex]'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C1319266', 'cui_str': 'mg/sq.m'}, {'cui': 'C0123931', 'cui_str': 'irinotecan'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",47.0,0.0466639,"There are no statistical differences in EFS (p=0.47) and OS (p=0.06) between two arms. ","[{'ForeName': 'V I', 'Initials': 'VI', 'LastName': 'Vorobyev', 'Affiliation': 'Botkin Moscow City Clinical Hospital.'}, {'ForeName': 'E G', 'Initials': 'EG', 'LastName': 'Gemdzhian', 'Affiliation': 'National Research Center for Hematology.'}, {'ForeName': 'E I', 'Initials': 'EI', 'LastName': 'Dubrovin', 'Affiliation': 'Botkin Moscow City Clinical Hospital.'}, {'ForeName': 'E S', 'Initials': 'ES', 'LastName': 'Nesterova', 'Affiliation': 'National Research Center for Hematology.'}, {'ForeName': 'K D', 'Initials': 'KD', 'LastName': 'Kaplanov', 'Affiliation': 'Volgograd Regional Clinical Oncologic Dispensary.'}, {'ForeName': 'E M', 'Initials': 'EM', 'LastName': 'Volodicheva', 'Affiliation': 'Tula Region Hospital.'}, {'ForeName': 'V A', 'Initials': 'VA', 'LastName': 'Zherebtsova', 'Affiliation': 'Botkin Moscow City Clinical Hospital.'}, {'ForeName': 'S K', 'Initials': 'SK', 'LastName': 'Kravchenko', 'Affiliation': 'National Research Center for Hematology.'}]",Terapevticheskii arkhiv,['10.26442/00403660.2019.07.000322'] 2439,32598751,[The efficacy and safety of quadruple therapy without bismuth (concomitant therapy) in the treatment of patients with Helicobacter pylori - associated gastric and duodenal peptic ulcer disease].,"AIM Evaluation of the efficacy and safety of quadrupletherapy without bismuth (concomitant therapy) in patients with Helicobacter pylori - associated gastric ulcer and duodenal ulcer in the framework of a comparative research in the population of patients in Russia. MATERIALS AND METHODS A prospective randomized trial was conducted, which included 210 patients with H. pylori - associated gastric/duodenal ulcer without complications. During the process of randomization, the patients were divided into three equal groups (n=70) depending on the prescribed 10-day scheme of eradication therapy (ET): the first group received the classic triple scheme (Omeprazole 20 mg 2 times a day, Amoxicillin 1000 mg 2 times a day and Clarithromycin 500 mg 2 times a day); the second group received quadruple therapy with bismuth drugs (Omeprazole 20 mg 2 times a day, Tetracycline 500 mg 4 times a day, Metronidazole 500 mg 3 times a day, Bismuth subcitrate potassium 120 mg 4 times a day); the third group received quadruple therapy without bismuth - concomitant therapy (Omeprazole 20 mg 2 times a day, Amoxicillin 1000 mg 2 times a day, Clarithromycin 500 mg 2 times a day and Metronidazole 500 mg 2 times a day). Diagnostics of H. pylori infection during screening and control of eradication was carried out via the fast urease biopsy sample test and urea breath test system. Control of the effectiveness of ET of the microorganism was carried out not earlier than 4 weeks after the end of the treatment. During the course of therapy, the frequency of development of side effects was assessed using a special questionnaire. RESULTS AND DISCUSSION The effectiveness of triple therapy was 72.8% (ITT; 95% CI of 62.17-83.54) and 78,4% (PP; 95% CI 68.19-88.72); quadruple therapy with the preparation of bismuth - 80.0% (ITT; 95% CI 70.39-89.6) and 84,8% (PP; 95% CI, 75.96-93.73); quadruple therapy without bismuth - concomitant therapy - 84.2% (ITT; 95% CI 75.54-93.02) and 92.1% (PP; 95% CI 85.43-98.94). Quadruple therapy without bismuth was reliably more effective than the classical triple therapy in the PP selection (p=0.044883). Statistical analysis showed a tendency to poorer effectiveness of ET in patients who had previously used antibiotic therapy (OR 0.4317; 95% CI 0.1776-1.049), and in individuals with a rapid metabolism genotype - CYP2C19*1/*1 (OR 0.12; 95% CI 0.005848-2.4624). The frequency of development of side effects during the use of triple therapy was 18.5% (95% CI of 9.23-27.91), when using quadruple therapy with bismuth - 20.0% (95% CI 10.39-29.6), and with the use of quadruple therapy without bismuth - concomitant therapy - 24.2% (95% CI 13.98-34.58). CONCLUSION This prospective randomized study demonstrated the high efficiency of quadruple therapy without bismuth (concomitant therapy) in the framework of eradication of H. pylori infection in Russia.",2019,"The effectiveness of triple therapy was 72.8% (ITT; 95% CI of 62.17-83.54) and 78,4% (PP; 95% CI 68.19-88.72); quadruple therapy with the preparation of bismuth - 80.0% (ITT; 95% CI 70.39-89.6) and 84,8% (PP; 95% CI, 75.96-93.73); quadruple therapy without bismuth - concomitant therapy - 84.2% (ITT; 95% CI 75.54-93.02) and 92.1% (PP; 95% CI 85.43-98.94).","['H. pylori infection in Russia', '210 patients with H. pylori - associated gastric/duodenal ulcer without complications', 'patients with Helicobacter pylori - associated gastric ulcer and duodenal ulcer in the framework of a comparative research in the population of patients in Russia', 'patients with Helicobacter pylori - associated gastric and duodenal peptic ulcer disease']","['quadruple therapy with bismuth drugs (Omeprazole 20 mg 2 times a day, Tetracycline 500 mg 4 times a day, Metronidazole 500 mg 3 times a day, Bismuth subcitrate potassium', 'quadruple therapy without bismuth - concomitant therapy (Omeprazole 20 mg 2 times a day, Amoxicillin 1000 mg 2 times a day, Clarithromycin 500 mg 2 times a day and Metronidazole', 'quadrupletherapy without bismuth (concomitant therapy', 'quadruple therapy without bismuth (concomitant therapy', 'classic triple scheme (Omeprazole 20 mg 2 times a day, Amoxicillin 1000 mg 2 times a day and Clarithromycin']","['efficacy and safety', 'frequency of development of side effects']","[{'cui': 'C0850666', 'cui_str': 'Infection caused by Helicobacter pylori'}, {'cui': 'C0035970', 'cui_str': 'Russian federation - Europe'}, {'cui': 'C4319559', 'cui_str': '210'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0079488', 'cui_str': 'Helicobacter pylori'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0038351', 'cui_str': 'Stomach'}, {'cui': 'C0013295', 'cui_str': 'Ulcer of duodenum'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0038358', 'cui_str': 'Gastric ulcer'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0013303', 'cui_str': 'Duodenal'}, {'cui': 'C0030920', 'cui_str': 'Peptic ulcer'}]","[{'cui': 'C0205175', 'cui_str': 'Quadruple'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0005642', 'cui_str': 'Bismuth'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0988268', 'cui_str': 'Omeprazole 20 MG'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0039644', 'cui_str': 'Tetracycline'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0992611', 'cui_str': 'Metronidazole 500 MG'}, {'cui': 'C1951481', 'cui_str': 'Bismuth subcitrate potassium'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C1126881', 'cui_str': 'Amoxicillin 1000 MG'}, {'cui': 'C0984982', 'cui_str': 'Clarithromycin 500 MG'}, {'cui': 'C0025872', 'cui_str': 'Metronidazole'}, {'cui': 'C0439658', 'cui_str': 'Classic'}, {'cui': 'C0205174', 'cui_str': 'Triple'}, {'cui': 'C0055856', 'cui_str': 'Clarithromycin'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",210.0,0.0232179,"The effectiveness of triple therapy was 72.8% (ITT; 95% CI of 62.17-83.54) and 78,4% (PP; 95% CI 68.19-88.72); quadruple therapy with the preparation of bismuth - 80.0% (ITT; 95% CI 70.39-89.6) and 84,8% (PP; 95% CI, 75.96-93.73); quadruple therapy without bismuth - concomitant therapy - 84.2% (ITT; 95% CI 75.54-93.02) and 92.1% (PP; 95% CI 85.43-98.94).","[{'ForeName': 'A M', 'Initials': 'AM', 'LastName': 'Veliev', 'Affiliation': 'Yevdokimov Moscow State University of Medicine and Dentistry.'}, {'ForeName': 'I V', 'Initials': 'IV', 'LastName': 'Maev', 'Affiliation': 'Yevdokimov Moscow State University of Medicine and Dentistry.'}, {'ForeName': 'D N', 'Initials': 'DN', 'LastName': 'Andreev', 'Affiliation': 'Yevdokimov Moscow State University of Medicine and Dentistry.'}, {'ForeName': 'D T', 'Initials': 'DT', 'LastName': 'Dicheva', 'Affiliation': 'Yevdokimov Moscow State University of Medicine and Dentistry.'}, {'ForeName': 'A V', 'Initials': 'AV', 'LastName': 'Zaborovskii', 'Affiliation': 'Yevdokimov Moscow State University of Medicine and Dentistry.'}, {'ForeName': 'E G', 'Initials': 'EG', 'LastName': 'Lobanova', 'Affiliation': 'Yevdokimov Moscow State University of Medicine and Dentistry.'}, {'ForeName': 'L G', 'Initials': 'LG', 'LastName': 'Bektemirova', 'Affiliation': 'Yevdokimov Moscow State University of Medicine and Dentistry.'}]",Terapevticheskii arkhiv,['10.26442/00403660.2019.08.000382'] 2440,32606573,Difluprednate 0.05% versus Prednisolone Acetate Post-Phacoemulsification for Inflammation and Pain: An Efficacy and Safety Clinical Trial.,"Background The purpose of this study was to compare the efficacy and safety of difluprednate 0.05% (PRO-145) versus prednisolone acetate 1% (Prednefrin ® SF), for management of postoperative inflammation and pain, after cataract surgery. Methods This was a Phase III, multicenter, prospective, double-blind, clinical trial. Intent-to-treat population included 178 post-phacoemulsification patients that were assigned to receive either PRO-145, or prednisolone. One day after unilateral eye surgery, patients instilled a drop 4 times a day for 14 days (then tapering the dose downward for 14 days). The primary efficacy endpoints were anterior chamber (AC) cell grade and flare. Other parameters measured included: retinal central thickness (measured via OCT), conjunctival hyperemia, edema, pain and photophobia. Tolerability and safety were assessed through burning, itching, foreign body sensation, visual acuity (VA), intraocular pressure (IOP) and incidence of adverse events (AE). Results A total of 171 subjects were randomized (1:1) and completed the study. Compared to day 1, there was a significant improvement in the AC cell count and flare in both groups by the final visit (80.2% vs 88.4%, p=1.000). Conjunctival hyperemia improved in a similar fashion (81.2% vs 79%, p=0.234) in both PRO-145 and prednisolone groups, without differences between them. This was also observed for edema (82.4% vs 82.5%, p=0.246), pain (15.3% vs 7%, p=0.497) and photophobia (16.4% vs 15.1%, p=0.246), respectively. There was no significant difference between treatments for any tolerability parameter studied. Finally, at the 4-week postoperative visit, there were no significant differences between treatments for VA, IOP and AE results (p-values; 0.095, 0.053 and 0.099, respectively). Conclusion The results of this study suggest that PRO-145 is as effective and safe as prednisolone acetate in treating postoperative inflammation and pain in patients undergoing phacoemulsification. The study was registered at ClinicalTrials.gov as NCT03693989.",2020,"Conjunctival hyperemia improved in a similar fashion (81.2% vs 79%, p=0.234) in both PRO-145 and prednisolone groups, without differences between them.","['Intent-to-treat population included 178 post-phacoemulsification patients', 'patients undergoing phacoemulsification', 'A total of 171 subjects']","['Prednisolone Acetate Post-Phacoemulsification', 'prednisolone acetate', 'PRO-145', 'PRO-145, or prednisolone', 'prednisolone', 'prednisolone acetate 1% (Prednefrin ® SF']","['AC cell count and flare', 'anterior chamber (AC) cell grade and flare', 'edema', 'Inflammation and Pain', 'efficacy and safety', 'retinal central thickness (measured via OCT), conjunctival hyperemia, edema, pain and photophobia', 'Conjunctival hyperemia', 'pain', 'burning, itching, foreign body sensation, visual acuity (VA), intraocular pressure (IOP) and incidence of adverse events (AE', 'photophobia', 'VA, IOP and AE results', 'Tolerability and safety']","[{'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0282545', 'cui_str': 'Phacoemulsification'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439810', 'cui_str': 'Total'}]","[{'cui': 'C0071839', 'cui_str': 'Prednisolone acetate'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0282545', 'cui_str': 'Phacoemulsification'}, {'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C4517577', 'cui_str': '145'}, {'cui': 'C0032950', 'cui_str': 'prednisolone'}, {'cui': 'C0603811', 'cui_str': 'prednefrin'}]","[{'cui': 'C0423282', 'cui_str': 'Anterior chamber cells'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0003151', 'cui_str': 'Anterior chamber of eye structure'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0013604', 'cui_str': 'Edema'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0035298', 'cui_str': 'Retinal structure'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0029279', 'cui_str': 'Ornithine carbamoyltransferase'}, {'cui': 'C1761613', 'cui_str': 'Conjunctival hyperemia'}, {'cui': 'C0085636', 'cui_str': 'Photophobia'}, {'cui': 'C0000912', 'cui_str': 'Accident caused by unspecified fire'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C0423602', 'cui_str': 'Foreign body sensation'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0678226', 'cui_str': 'Due to'}]",171.0,0.384614,"Conjunctival hyperemia improved in a similar fashion (81.2% vs 79%, p=0.234) in both PRO-145 and prednisolone groups, without differences between them.","[{'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Palacio-Pastrana', 'Affiliation': 'Fundación Hospital Nuestra Señora de la Luz, IAP, CDMX, Mexico.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Chávez-Mondragón', 'Affiliation': 'Fundación de Asistencia Privada Conde de Valenciana, IAP, CDMX, Mexico.'}, {'ForeName': 'Abraham', 'Initials': 'A', 'LastName': 'Soto-Gómez', 'Affiliation': 'Catarata y Glaucoma de Occidente SA de CV, Guadalajara, Jalisco, Mexico.'}, {'ForeName': 'Rubén', 'Initials': 'R', 'LastName': 'Suárez-Velasco', 'Affiliation': 'Private Office, Guadalajara, Jalisco, Mexico.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Montes-Salcedo', 'Affiliation': 'Aris Vision Institute, Guadalajara, Jalisco, Mexico.'}, {'ForeName': 'Lourdes', 'Initials': 'L', 'LastName': 'Fernández de Ortega', 'Affiliation': 'Asociación Para Evitar la Ceguera en México, IAP, CDMX, Mexico.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Nasser-Nasser', 'Affiliation': 'Visión Cirugía Ambulatoria, Monterrey, Nuevo Leon, Mexico.'}, {'ForeName': 'Leopoldo', 'Initials': 'L', 'LastName': 'Baiza-Durán', 'Affiliation': 'Medical Affairs, Laboratorios Sophia, SA de CV, Zapopan, Jalisco, Mexico.'}, {'ForeName': 'Oscar', 'Initials': 'O', 'LastName': 'Olvera-Montaño', 'Affiliation': 'Medical Affairs, Laboratorios Sophia, SA de CV, Zapopan, Jalisco, Mexico.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Muñoz-Villegas', 'Affiliation': 'Medical Affairs, Laboratorios Sophia, SA de CV, Zapopan, Jalisco, Mexico.'}]","Clinical ophthalmology (Auckland, N.Z.)",['10.2147/OPTH.S254705'] 2441,32606578,Predictors of Early Diabetic Retinopathy Regression with Ranibizumab in the RIDE and RISE Clinical Trials.,"Purpose To investigate the predictors of early diabetic retinopathy (DR) improvement in the RIDE/RISE (NCT00473382/NCT00473330) clinical trials. Patients and Methods In RIDE/RISE, adult patients with vision loss due to diabetic macular edema (DME) were randomized to monthly intravitreal ranibizumab 0.3 or 0.5 mg (n=502 total) or sham (n=257). DR severity was graded (using the Early Treatment Diabetic Retinopathy Study Diabetic Retinopathy Severity Scale). In this post hoc analysis of RIDE/RISE, eyes with baseline DR score ≥35 were evaluated for ≥2-step improvements, and eyes with baseline DR score ≥43 were evaluated for ≥3-step improvements. The characteristics associated with ≥2- or ≥3-step DR improvement at months 3 or 6 were assessed using univariate and/or multivariable analyses. Results The percentage of eyes with a ≥2- or ≥3-step DR improvement was 20.1% and 3.7% at month 3 and 31.2% and 5.8% at month 6. Odds of ≥2-step DR improvement at months 3 or 6 were significantly greater in eyes with moderately severe to severe nonproliferative DR (NPDR) at baseline versus less severe or more severe DR (both P <0.0001). At month 6, odds of ≥2-step DR improvement were significantly greater in eyes with no DME at month 3 ( P =0.008). Most patients with ≥3-step DR improvement at months 3 or 6 had proliferative DR (PDR) at baseline (83.3% and 66.7%). Conclusion The strongest predictors of DR response to ranibizumab at month 6 were baseline DR severity and DME quiescence at month 3. Eyes with the most robust early improvements had moderately severe or severe NPDR or PDR at baseline.",2020,Odds of ≥2-step DR improvement at months 3 or 6 were significantly greater in eyes with moderately severe to severe nonproliferative DR,['adult patients with vision loss due to diabetic macular edema (DME'],"['Ranibizumab', 'intravitreal ranibizumab', 'ranibizumab']","['severe nonproliferative DR', 'percentage of eyes with a ≥2- or ≥3-step DR improvement', '≥2- or ≥3-step DR improvement', 'DR response', '≥2-step DR improvement', 'DR severity', 'moderately severe or severe NPDR or PDR', 'severe DR', 'proliferative DR (PDR', 'early diabetic retinopathy (DR', 'Odds of ≥2-step DR improvement']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3665346', 'cui_str': 'Unspecified visual loss'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0730285', 'cui_str': 'Macular edema due to diabetes mellitus'}]","[{'cui': 'C1566537', 'cui_str': 'ranibizumab'}, {'cui': 'C1517572', 'cui_str': 'Intravitreal route'}]","[{'cui': 'C0730278', 'cui_str': 'Severe nonproliferative diabetic retinopathy'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0011884', 'cui_str': 'Retinopathy due to diabetes mellitus'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1845050', 'cui_str': 'Pigmentary Disorder, Reticulate, with Systemic Manifestations'}, {'cui': 'C0154830', 'cui_str': 'Proliferative retinopathy with diabetes mellitus'}, {'cui': 'C1279919', 'cui_str': 'Early'}]",,0.0458363,Odds of ≥2-step DR improvement at months 3 or 6 were significantly greater in eyes with moderately severe to severe nonproliferative DR,"[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Singer', 'Affiliation': 'Medical Center Ophthalmology Associates, San Antonio, TX, USA.'}, {'ForeName': 'Mimi', 'Initials': 'M', 'LastName': 'Liu', 'Affiliation': 'Colorado Retina Associates, Denver, CO, USA.'}, {'ForeName': 'Patricio G', 'Initials': 'PG', 'LastName': 'Schlottmann', 'Affiliation': 'Organizacion Medica de Investigacion, Buenos Aires, Argentina.'}, {'ForeName': 'Arshad M', 'Initials': 'AM', 'LastName': 'Khanani', 'Affiliation': 'Sierra Eye Associates, Reno, NV, USA.'}, {'ForeName': 'Miranda', 'Initials': 'M', 'LastName': 'Hemphill', 'Affiliation': 'Genentech, Inc., South San Francisco, CA, USA.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Hill', 'Affiliation': 'Genentech, Inc., South San Francisco, CA, USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Tuomi', 'Affiliation': 'Genentech, Inc., South San Francisco, CA, USA.'}, {'ForeName': 'Zdenka', 'Initials': 'Z', 'LastName': 'Haskova', 'Affiliation': 'Genentech, Inc., South San Francisco, CA, USA.'}]","Clinical ophthalmology (Auckland, N.Z.)",['10.2147/OPTH.S247061'] 2442,32606580,"Efficacy and Safety of VisuEvo ® and Cationorm ® for the Treatment of Evaporative and Non-Evaporative Dry Eye Disease: A Multicenter, Double-Blind, Cross-Over, Randomized Clinical Trial.","Purpose To compare the efficacy of the new lubricating product VisuEvo ® (VSE) vs Cationorm ® (CTN) in patients with dry eye disease (DED). Methods Seventy-two patients with evaporative (n=54) and non-evaporative DED (n=18) were included in a multicenter, double-blind, 12-week cross-over study to receive VSE (6 weeks) and CTN (6 weeks) in randomized sequence. After baseline, two visits were performed during each period (intermediate and final visit, respectively at 2 and 6 weeks from the beginning of each period). Primary (tear break-up time, TBUT) and secondary endpoints (Schirmer I, Ferning, blink rate, osmometry, cytokine and lipid expression, ocular surface staining, patient satisfaction, and OSDI score) were compared. Results Sixty-three patients were evaluated for efficacy and 68 patients for safety. The intergroup differences for mean TBUT values were not significant at any study visit (baseline 3.2 ±1.5 sec; intermediate visits 4.5 ± 1.9 and 4.5 ± 1.8 sec in VSE and CTN groups, respectively, p = 0.10; final visits 5.4 ± 2.4 and 6.0 ± 3.1, respectively, p=0.63). Also, the assessment of secondary endpoints showed no significant difference between the two groups. The two study treatments were equally effective in evaporative and non-evaporative DED. The safety profile was excellent for both ocular treatments; transient blurred vision was observed in 11 patients only during CTN, 10 patients only during VSE, and 16 during both treatments. Conclusion VSE was non-inferior to CTN in restoring tear film composition, increasing its stability and reducing ocular surface damage in evaporative and non-evaporative DED patients. Study Identifier NCT03833882.",2020,"The safety profile was excellent for both ocular treatments; transient blurred vision was observed in 11 patients only during CTN, 10 patients only during VSE, and 16 during both treatments. ","['patients with dry eye disease (DED', 'Methods\n\n\nSeventy-two patients with evaporative (n=54) and non-evaporative DED (n=18', 'Evaporative and Non-Evaporative Dry Eye Disease']","['new lubricating product VisuEvo ® (VSE) vs Cationorm ® (CTN', 'CTN', 'VSE', 'VisuEvo ® and Cationorm ®']","['blurred vision', 'safety profile', 'mean TBUT values', 'effective in evaporative and non-evaporative DED', 'Schirmer I, Ferning, blink rate, osmometry, cytokine and lipid expression, ocular surface staining, patient satisfaction, and OSDI score', 'Primary (tear break-up time, TBUT) and secondary endpoints ']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013238', 'cui_str': 'Dry Eye Disease'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4319632', 'cui_str': '72'}, {'cui': 'C5197850', 'cui_str': 'Evaporative Dry Eye Syndrome'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C4043842', 'cui_str': 'Cationorm'}, {'cui': 'C0917591', 'cui_str': 'CTN'}]","[{'cui': 'C0344232', 'cui_str': 'Hazy vision'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0331729', 'cui_str': 'Fern'}, {'cui': 'C0005757', 'cui_str': 'Blinking'}, {'cui': 'C3179117', 'cui_str': 'Osmometry'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0038128', 'cui_str': 'Stain'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}]",72.0,0.0462878,"The safety profile was excellent for both ocular treatments; transient blurred vision was observed in 11 patients only during CTN, 10 patients only during VSE, and 16 during both treatments. ","[{'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Fogagnolo', 'Affiliation': 'Eye Clinic ASST Santi Paolo Carlo, Department of Health Sciences, San Paolo Hospital, University of Milan, Milan, Italy.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Quisisana', 'Affiliation': 'Eye Clinic ASST Santi Paolo Carlo, Department of Health Sciences, San Paolo Hospital, University of Milan, Milan, Italy.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Caretti', 'Affiliation': 'Department of Health Sciences, Laboratory of Biochemistry, University of Milan, Milan, Italy.'}, {'ForeName': 'Daniele', 'Initials': 'D', 'LastName': 'Marchina', 'Affiliation': 'Eye Clinic ASST Santi Paolo Carlo, Department of Health Sciences, San Paolo Hospital, University of Milan, Milan, Italy.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Dei Cas', 'Affiliation': 'Department of Health Sciences, Laboratory of Biochemistry, University of Milan, Milan, Italy.'}, {'ForeName': 'Ettore', 'Initials': 'E', 'LastName': 'Melardi', 'Affiliation': 'Eye Clinic ASST Santi Paolo Carlo, Department of Health Sciences, San Paolo Hospital, University of Milan, Milan, Italy.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Rossetti', 'Affiliation': 'Eye Clinic ASST Santi Paolo Carlo, Department of Health Sciences, San Paolo Hospital, University of Milan, Milan, Italy.'}]","Clinical ophthalmology (Auckland, N.Z.)",['10.2147/OPTH.S258081'] 2443,32606581,A Comparison of Efficacy and Safety of Two Lipid-Based Lubricant Eye Drops for the Management of Evaporative Dry Eye Disease.,"Purpose The aim of this study was to compare the efficacy of two lipid-based lubricant eye drops in patients with lipid-deficient dry eye. Methods This Phase IV, multicenter, prospective, double-masked study enrolled adults (aged ≥18 years) who had a tear film breakup time (TFBUT) of ≤15 seconds(s), and unanesthetized Schirmer I test of ≥3 mm to ≤12 mm in at least one eye, at both screening and baseline visits. Eligible patients (n=231) were randomized (1:1) and received either Systane ® Balance (SYSB; n=117) or Refresh ® Optive Advanced (RFO-Ad, n=114), four-times a day, for 35 days. The primary endpoint was non-inferiority for change from baseline in TFBUT at Day 35 (non-inferiority was established if the lower limit of the 95% confidence interval (CI) for the difference between the treatment groups was > -1.0 s); secondary endpoints (test of superiority) were change in TFBUT and global ocular discomfort visual analog scale (VAS) score at Day 35. Other endpoints included the impact of dry eye on everyday life (IDEEL) treatment satisfaction scores (inconvenience and effectiveness) and safety. Results At Day 35, the mean change from baseline in TFBUT was 0.998 s in the SYSB and 0.868 s in the RFO-Ad groups with a treatment difference: 0.130 s; (95% CI -0.34, 0.60; P <0.0001) demonstrating non-inferiority of SYSB to RFO-Ad. The global ocular discomfort VAS scores improved in both groups, with a mean change from baseline of -9.7 and -8.8 in SYSB and RFO-Ad groups (treatment difference -0.8; P =0.62), respectively. No meaningful difference was observed in IDEEL treatment effectiveness and treatment inconvenience scores between SYSB vs RFO-Ad ( P >0.05 for treatment difference). Both treatments were well tolerated. Conclusion SYSB lubricant eye drops were non-inferior to RFO-Ad for improvement in TFBUT in patients with lipid-deficient dry eye. Both lubricant eye drops improved TFBUT and ocular discomfort scores in patients with lipid-deficient dry eye.",2020,No meaningful difference was observed in IDEEL treatment effectiveness and treatment inconvenience scores between SYSB vs RFO-Ad ( P >0.05 for treatment difference).,"['patients with lipid-deficient dry eye', 'Evaporative Dry Eye Disease', 'Eligible patients (n=231', 'enrolled adults (aged ≥18 years) who had a tear film breakup time (TFBUT) of ≤15 seconds(s), and unanesthetized Schirmer I test of ≥3 mm to ≤12 mm in at least one eye, at both screening and baseline visits']","['lipid-based lubricant eye drops', 'Systane ® Balance (SYSB; n=117) or Refresh ®', 'Two Lipid-Based Lubricant Eye Drops']","['global ocular discomfort VAS scores', 'tolerated', 'impact of dry eye on everyday life (IDEEL) treatment satisfaction scores (inconvenience and effectiveness) and safety', 'non-inferiority for change from baseline in TFBUT', 'change in TFBUT and global ocular discomfort visual analog scale (VAS) score', 'TFBUT and ocular discomfort scores', 'IDEEL treatment effectiveness and treatment inconvenience scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0011155', 'cui_str': 'Deficiency'}, {'cui': 'C0013238', 'cui_str': 'Dry Eye Disease'}, {'cui': 'C5197850', 'cui_str': 'Evaporative Dry Eye Syndrome'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C1704608', 'cui_str': 'Film'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C1301514', 'cui_str': 'Schirmer I test'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]","[{'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C2608262', 'cui_str': 'Artificial Tears'}, {'cui': 'C1655274', 'cui_str': 'Systane'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0948595', 'cui_str': 'Ocular discomfort'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0013238', 'cui_str': 'Dry Eye Disease'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0237666', 'cui_str': 'Inferiority feeling'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C1704608', 'cui_str': 'Film'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0087113', 'cui_str': 'Clinical Efficacy'}]",231.0,0.29013,No meaningful difference was observed in IDEEL treatment effectiveness and treatment inconvenience scores between SYSB vs RFO-Ad ( P >0.05 for treatment difference).,"[{'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Jerkins', 'Affiliation': 'Advancing Vision Research, LLC, Nashville, TN, USA.'}, {'ForeName': 'Jack V', 'Initials': 'JV', 'LastName': 'Greiner', 'Affiliation': 'Clinical Eye Research of Boston, Boston, MA, USA.'}, {'ForeName': 'Louis', 'Initials': 'L', 'LastName': 'Tong', 'Affiliation': 'Singapore National Eye Center, National University of Singapore, Singapore.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Tan', 'Affiliation': 'University of New South Wales, Sydney, NSW, Australia.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Tauber', 'Affiliation': 'Tauber Eye Center, Kansas City, MO, USA.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Mearza', 'Affiliation': 'Imperial College Healthcare NHS Trust, London, UK.'}, {'ForeName': 'Sruthi', 'Initials': 'S', 'LastName': 'Srinivasan', 'Affiliation': 'Alcon Research, LLC, Johns Creek, GA, USA.'}]","Clinical ophthalmology (Auckland, N.Z.)",['10.2147/OPTH.S256351'] 2444,32606705,Comparison of Relapse Prevention with 3 Different Paliperidone Formulations in Patients with Schizophrenia Continuing versus Discontinuing Active Antipsychotic Treatment: A Post-Hoc Analysis of 3 Similarly Designed Randomized Studies.,"Background Sudden discontinuation from antipsychotic treatment is a common occurrence in patients with schizophrenia. Lower rates of relapse could be expected for patients discontinuing treatment from longer-acting formulations vs their shorter-acting equivalents. Objective To compare relapse rates and time-to-relapse between the active (analogous to adherent patients) and placebo (analogous to non-adherent patients in the real-world) arms of three different formulations of paliperidone (oral paliperidone extended release [paliperidone ER], paliperidone palmitate once monthly [PP1M], and paliperidone palmitate three monthly [PP3M] long-acting injectables). Methods Data from three similarly designed, randomized relapse prevention studies in adult patients with schizophrenia were analyzed. Results In total, 922 patients were included (active treatment: 473, placebo: 449). Lowest percentage of patients experienced relapse with PP3M PP1M (172 days [134-222 days])> paliperidone ER (58 days [42-114 days]) and was ""not-estimable"" in the active treatment group due to low relapse rates. Hazard ratios (HR) of the three paliperidone formulations relative to their respective placebos were PP3M ([HR: 3.81; 95% CI: 2.08, 6.99; P< 0.0001]> PP1M [HR: 3.60; 95% CI: 2.45, 5.28; P<0.0001]> paliperidone ER [HR: 2.83; 95% CI: 1.73, 4.63; P<0.001]). Conclusion The lower percentage of relapse during active treatment and longer time to relapse after discontinuing active treatment with longer-duration antipsychotic formulations suggests the benefit of longer-acting over shorter-acting formulations, especially in patients susceptible to poor adherence. Clinical trial registration: paliperidone ER (NCT00086320), PP1M (NCT00111189), and PP3M (NCT01529515).",2020,"PP1M [HR: 3.60; 95% CI: 2.45, 5.28; P<0.0001]","['patients with schizophrenia', 'Patients with Schizophrenia Continuing versus Discontinuing Active Antipsychotic Treatment', 'adult patients with schizophrenia', '922 patients were included (active treatment: 473']","['paliperidone palmitate', 'Paliperidone Formulations', 'paliperidone (oral paliperidone extended release [paliperidone ER], paliperidone palmitate', 'PP3M', 'paliperidone ER [HR', 'paliperidone ER', 'placebo']","['relapse rates and time-to-relapse', 'Hazard ratios (HR']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0040615', 'cui_str': 'Antipsychotic agent'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C2719626', 'cui_str': 'Paliperidone palmitate'}, {'cui': 'C0753678', 'cui_str': 'paliperidone'}, {'cui': 'C0524527', 'cui_str': 'Pharmaceutical Formulation'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",922.0,0.769899,"PP1M [HR: 3.60; 95% CI: 2.45, 5.28; P<0.0001]","[{'ForeName': 'Maju', 'Initials': 'M', 'LastName': 'Mathews', 'Affiliation': 'Global Medical Affairs, Janssen Research & Development, LLC, Titusville, NJ, USA.'}, {'ForeName': 'Srihari', 'Initials': 'S', 'LastName': 'Gopal', 'Affiliation': 'Department of Neuroscience, Janssen Research & Development, LLC, Titusville, NJ, USA.'}, {'ForeName': 'Arun', 'Initials': 'A', 'LastName': 'Singh', 'Affiliation': 'Department of Neuroscience, Janssen Research & Development, LLC, Pennington, PA, USA.'}, {'ForeName': 'Isaac', 'Initials': 'I', 'LastName': 'Nuamah', 'Affiliation': 'Clinical Biostatistics, Janssen Research & Development, LLC, Titusville, NJ, USA.'}, {'ForeName': 'Katalin', 'Initials': 'K', 'LastName': 'Pungor', 'Affiliation': 'Medical Affairs, Janssen-Cilag GmbH, Neuss, North Rhine-Westphalia, Germany.'}, {'ForeName': 'Wilson', 'Initials': 'W', 'LastName': 'Tan', 'Affiliation': 'Regional Medical Affairs, Janssen Pharmaceutical Companies of Johnson and Johnson, Singapore.'}, {'ForeName': 'Bernardo', 'Initials': 'B', 'LastName': 'Soares', 'Affiliation': 'Medical Affairs, Jan-Cil, High Wycombe, Buckinghamshire, UK.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Kim', 'Affiliation': 'Janssen Scientific Affairs, Janssen Scientific Affairs, LLC, Titusville, NJ, USA.'}, {'ForeName': 'Adam J', 'Initials': 'AJ', 'LastName': 'Savitz', 'Affiliation': 'Department of Neuroscience, Janssen Research & Development, LLC, Titusville, NJ, USA.'}]",Neuropsychiatric disease and treatment,['10.2147/NDT.S221242'] 2445,32606715,Iliac Bone Harvesting Techniques for Bone Reconstruction. Comparative Study Between Tricortical Bone Harvesting vs Trapdoor Technique.,"Objective To investigate the effects of trapdoor-procedure-based bone harvesting and tricortical iliac bone harvesting on the iliac bone-graft donor site pain experienced by patients and their clinical effects. Methods A retrospective analysis was performed using the clinical data of 65 patients with tibial plateau fractures who received autologous iliac bone-supporting grafts in two hospitals between January 2014 and January 2019. The patients who received trapdoor-procedure-based bone harvesting (34 cases) were in the experimental group, and those who received tricortical iliac bone harvesting (31 cases) were in the control group. This study compared differences in iliac bone-graft donor site incision length, intraoperative blood loss, amount of bones harvested, operation time, and postoperative complications between the two bone-harvesting methods. Subsequently, it evaluated the pain experienced by the two patient groups in their iliac bone-graft donor sites and their clinical effects. Results One week after surgery, the differences between the iliac bone-graft donor site pain score (measured using SF-MPQ-2) of the experimental group and the control group were not statistically different. However, 3 weeks, 5 weeks, and 3 months after surgery, the iliac bone-graft donor site pain scores of the experimental group were significantly lower than those of the control group. The iliac bone-graft donor site incision length and operation time of the experimental group were not significantly different from those of the control group. However, the iliac bone-graft donor site intraoperative blood loss, amount of bones harvested and the incidence of complications of the experimental group were significantly lower than those of the control group. Conclusion Trapdoor-procedure-based bone harvesting has lower donor site pain, intraoperative blood loss, and postoperative complications. However, for bone grafting in regions with significant bone loss, tricortical iliac bone harvesting remains the optimal option.",2020,The iliac bone-graft donor site incision length and operation time of the experimental group were not significantly different from those of the control group.,"['in two hospitals between January 2014 and January 2019', '65 patients with tibial plateau fractures who received']","['tricortical iliac bone harvesting', 'Tricortical Bone Harvesting vs Trapdoor Technique', 'Iliac Bone Harvesting Techniques', 'autologous iliac bone-supporting grafts', 'trapdoor-procedure-based bone harvesting and tricortical iliac bone harvesting', 'trapdoor-procedure-based bone harvesting']","['iliac bone-graft donor site intraoperative blood loss, amount of bones harvested and the incidence of complications', 'iliac bone-graft donor site pain score', 'iliac bone-graft donor site incision length, intraoperative blood loss, amount of bones harvested, operation time, and postoperative complications', 'iliac bone-graft donor site pain scores', 'iliac bone-graft donor site incision length and operation time']","[{'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0262489', 'cui_str': 'Fracture of tibial plateau'}]","[{'cui': 'C0020889', 'cui_str': 'Bone structure of ilium'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0020889', 'cui_str': 'Bone structure of ilium'}, {'cui': 'C0730393', 'cui_str': 'Donor graft'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}]",65.0,0.0373361,The iliac bone-graft donor site incision length and operation time of the experimental group were not significantly different from those of the control group.,"[{'ForeName': 'Jia-Fu', 'Initials': 'JF', 'LastName': 'Zhu', 'Affiliation': ""Department of Orthopaedics, Tongde Hospital of Zhejiang Province, Hangzhou 310012, People's Republic of China.""}, {'ForeName': 'Wei-Xing', 'Initials': 'WX', 'LastName': 'Xu', 'Affiliation': ""Department of Orthopaedics, Tongde Hospital of Zhejiang Province, Hangzhou 310012, People's Republic of China.""}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Hu', 'Affiliation': ""Department of Orthopaedics, Tongde Hospital of Zhejiang Province, Hangzhou 310012, People's Republic of China.""}, {'ForeName': 'Tian-Quan', 'Initials': 'TQ', 'LastName': 'Wu', 'Affiliation': ""Department of Orthopaedics, Shaoxing Keqiao District Hospital of Traditional Chinese Medicine, Shaoxing 312030, People's Republic of China.""}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': ""Department of Orthopaedics, Tongde Hospital of Zhejiang Province, Hangzhou 310012, People's Republic of China.""}]",Therapeutics and clinical risk management,['10.2147/TCRM.S257336'] 2446,32606716,Safety and Efficacy of Turoctocog Alfa in the Prevention and Treatment of Bleeding Episodes in Previously Treated Patients from China with Severe Hemophilia A: Results from the Guardian 7 Trial.,"Purpose Hemophilia care in China is characterized by widespread use of on-demand regimens and low-dose prophylaxis. With a limited number of approved recombinant factor VIII (FVIII) products, the incidence of arthropathy and disability in hemophilia patients remains high in China. The purpose of this trial was to evaluate the safety and efficacy of turoctocog alfa for prophylaxis and treatment of bleeding episodes in patients from China with severe hemophilia A across all age groups. Patients and Methods In this Phase 3, open-label trial, previously treated males of all ages with severe hemophilia A from China received turoctocog alfa for prophylaxis or on-demand treatment of bleeds. The primary endpoint was hemostatic effect for the treatment of bleeds during the main phase of the trial. Secondary endpoints included annualized bleeding rate during prophylaxis and the frequency of FVIII inhibitor development. Results Overall, 42 pediatric patients (age <12 years) and 26 adolescent/adult patients (≥12 years) were dosed with turoctocog alfa; 51 patients initiated treatment with prophylaxis, while 17 patients initiated on-demand treatment. During the main phase of the trial (6 months), hemostatic success was 95.1%. During the full trial (up to 24 months), hemostatic success was 95.4%; the overall median ABR was 1.18 bleeds/patient/year for prophylaxis patients; and 25 (51.0%) of 49 patients with target joints at baseline had all target joints resolved. No FVIII inhibitors (≥0.6 BU) were reported. Conclusion Turoctocog alfa was safe and effective for prophylaxis and treatment of bleeding episodes and for surgery in patients from China with severe hemophilia A across all ages.",2020,"Conclusion Turoctocog alfa was safe and effective for prophylaxis and treatment of bleeding episodes and for surgery in patients from China with severe hemophilia","['hemophilia patients remains high in China', 'Previously Treated Patients from China with Severe Hemophilia A', 'previously treated males of all ages with severe hemophilia', 'patients from China with severe hemophilia', '42 pediatric patients (age <12 years) and 26 adolescent/adult patients (≥12 years', 'patients from China with severe hemophilia A across all age groups']","['Turoctocog Alfa', 'turoctocog alfa']","['overall median ABR', 'Bleeding Episodes', 'annualized bleeding rate during prophylaxis and the frequency of FVIII inhibitor development', 'Safety and Efficacy', 'bleeding episodes', 'hemostatic success', 'safety and efficacy', 'hemostatic effect']","[{'cui': 'C0019069', 'cui_str': 'Hereditary factor VIII deficiency disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0272322', 'cui_str': 'Severe hereditary factor VIII deficiency disease'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0027362', 'cui_str': 'Age Groups'}]","[{'cui': 'C3529563', 'cui_str': 'Turoctocog alfa'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0033107', 'cui_str': 'prevention & control'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0368953', 'cui_str': 'Factor VIII antibody'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0019116', 'cui_str': 'Hemostatic function'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",49.0,0.0707856,"Conclusion Turoctocog alfa was safe and effective for prophylaxis and treatment of bleeding episodes and for surgery in patients from China with severe hemophilia","[{'ForeName': 'Runhui', 'Initials': 'R', 'LastName': 'Wu', 'Affiliation': ""Hematology Oncology Center, Beijing Children's Hospital, Capital Medical University, National Children's Health Center, Beijing, People's Republic of China.""}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Sun', 'Affiliation': ""Department of Hematology, Nanfang Hospital, Southern Medical University, Guangzhou, People's Republic of China.""}, {'ForeName': 'Weiqun', 'Initials': 'W', 'LastName': 'Xu', 'Affiliation': ""Department of Hematology and Oncology, The Children's Hospital, Zhejiang University School of Medicine, National Clinical Research Center for Child Health, Hangzhou, People's Republic of China.""}, {'ForeName': 'Qun', 'Initials': 'Q', 'LastName': 'Hu', 'Affiliation': ""Department of Pediatric Hematology, Tongji Hospital, Tongji Medical College of HUST, Wuhan, People's Republic of China.""}, {'ForeName': 'Wenqian', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': ""Department of Hematology and Rheumatology, Qinghai Provincial People's Hospital, Xining, People's Republic of China.""}, {'ForeName': 'Jianwen', 'Initials': 'J', 'LastName': 'Xiao', 'Affiliation': ""Department of Hematology, Children's Hospital of Chongqing Medical University, Chongqing, People's Republic of China.""}, {'ForeName': ""Feng'e"", 'Initials': 'F', 'LastName': 'Yang', 'Affiliation': ""Department of Hematology, Fujian Medical University Union Hospital, Fuzhou, People's Republic of China.""}, {'ForeName': 'Xiaojing', 'Initials': 'X', 'LastName': 'Zeng', 'Affiliation': ""Department of Blood Transfusion, The Affiliated Hospital of Guizhou Medical University, Guiyang, People's Republic of China.""}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Zeng', 'Affiliation': ""Department of Hematology, First Affiliated Hospital of Kunming Medical University, Kunming, People's Republic of China.""}, {'ForeName': 'Jianfeng', 'Initials': 'J', 'LastName': 'Zhou', 'Affiliation': ""Department of Pediatric Hematology, Tongji Hospital, Tongji Medical College of HUST, Wuhan, People's Republic of China.""}, {'ForeName': 'Irina', 'Initials': 'I', 'LastName': 'Matytsina', 'Affiliation': 'Biopharm Medical & Science, Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Sali', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': ""Biopharm Clinical, Medical and Regulatory Affairs, Novo Nordisk (China) Pharmaceuticals Co., Ltd, Beijing, People's Republic of China.""}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Pluta', 'Affiliation': 'Statistical Consultancy, Quanticate Ltd, Hitchin, UK.'}, {'ForeName': 'Renchi', 'Initials': 'R', 'LastName': 'Yang', 'Affiliation': ""Thrombosis and Haemostasis Centre, State Key Laboratory of Experimental Hematology, Tianjin Laboratory of Blood Disease Gene Therapy, CAMS Key Laboratory of Gene Therapy for Blood Diseases, National Clinical Research Center for Hematological Disorders, Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, People's Republic of China.""}]",Therapeutics and clinical risk management,['10.2147/TCRM.S243146'] 2447,32606874,Changes in Body Composition and FTO Whole Blood DNA Methylation Among Japanese Women: A Randomized Clinical Trial of Weight-Loss Program.,"Objective DNA methylation is an epigenetic mechanism that regulates gene expression. The obesity-related ( FTO ) gene is the first gene found to be associated with fat mass and obesity. However, no studies have examined the relationship between weight-loss intervention effect and FTO methylation in obese individuals with whole blood DNA. The purpose of this study was to quantify FTO whole blood DNA methylation and investigate the relationship between body composition, exercise capacity, and blood parameters with a 6-month weight-loss program intervention. Participants and Methods Eighteen female participants (mean age, 50.6 ±12.1 years, body mass index (BMI), 33.5 ± 6.2 kg/m 2 ) who completed a 6-month weight-loss program at the obesity outpatient department at the Health Science Center of Kansai Medical University Hospital from March 2017 to October 2018 were included in the analysis. Participants were randomized into a normal treatment group (NTG) and a group with additional resistance training (RTG). Body composition, exercise tolerance and metabolic index were measured in each participant. DNA methylation status in whole blood samples was determined using pyrosequencing. All measurements were taken during the first visit and at the 6-month post-intervention visit. Results The methylation rate was significantly decreased in the NTG in CpG1 (p=0.011) and total value of CpG (p=0.011), whereas in the treatment group containing resistance training (RTG), CpG3 (p=0.038) was increased significantly. Furthermore, the independent factors that determine %CpG3 of RTG were visceral fat area change rate (%VFA) (β = -0.568, P = 0.007, R2 = 0.527) and resistance training (β = 0.517, P = 0.012, R2 = 0.527), which have been extracted. Conclusion A 6-month weight-loss program, including resistance training, may be associated with decreased visceral fat area changes and increased RTG CpG3 methylation changes. However, further replication studies with larger sample sizes are warranted to verify the findings of this study.",2020,"The methylation rate was significantly decreased in the NTG in CpG1 (p=0.011) and total value of CpG (p=0.011), whereas in the treatment group containing resistance training (RTG), CpG3 (p=0.038) was increased significantly.","['Japanese Women', 'obese individuals with whole blood DNA', 'Participants and Methods\n\n\nEighteen female participants (mean age, 50.6 ±12.1 years, body mass index (BMI), 33.5 ± 6.2 kg/m 2 ) who completed a 6-month weight-loss program at the obesity outpatient department at the Health Science Center of Kansai Medical University Hospital from March 2017 to October 2018 were included in the analysis']",['normal treatment group (NTG) and a group with additional resistance training (RTG'],"['methylation rate', 'Body Composition and FTO', 'Body composition, exercise tolerance and metabolic index', 'Whole Blood DNA Methylation', 'visceral fat area change rate', 'total value of CpG', 'visceral fat area changes and increased RTG CpG3 methylation changes']","[{'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood'}, {'cui': 'C0012854', 'cui_str': 'Deoxyribonucleic acid'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517820', 'cui_str': '6.2'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C3179079', 'cui_str': 'Weight Loss Programs'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0036397', 'cui_str': 'Science'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}]","[{'cui': 'C0025723', 'cui_str': 'Methylation'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0162521', 'cui_str': 'Exercise tolerance'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood'}, {'cui': 'C0376452', 'cui_str': 'DNA Methylation'}, {'cui': 'C1563740', 'cui_str': 'Abdominal Visceral Fat'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0056912', 'cui_str': ""cytidylyl-3'-5'-guanosine""}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}]",18.0,0.02288,"The methylation rate was significantly decreased in the NTG in CpG1 (p=0.011) and total value of CpG (p=0.011), whereas in the treatment group containing resistance training (RTG), CpG3 (p=0.038) was increased significantly.","[{'ForeName': 'Haruhiko', 'Initials': 'H', 'LastName': 'Nishida', 'Affiliation': 'Department of Health Science, Kansai Medical University, Osaka, Japan.'}, {'ForeName': 'Katsuko', 'Initials': 'K', 'LastName': 'Onishi', 'Affiliation': 'Department of Health Science, Kansai Medical University, Osaka, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Kurose', 'Affiliation': 'Department of Health Science, Kansai Medical University, Osaka, Japan.'}, {'ForeName': 'Hiromi', 'Initials': 'H', 'LastName': 'Tsutsumi', 'Affiliation': 'Department of Health Science, Kansai Medical University, Osaka, Japan.'}, {'ForeName': 'Takumi', 'Initials': 'T', 'LastName': 'Miyauchi', 'Affiliation': 'Health Science Center, Kansai Medical University, Osaka, Japan.'}, {'ForeName': 'Nana', 'Initials': 'N', 'LastName': 'Takao', 'Affiliation': 'Health Science Center, Kansai Medical University, Osaka, Japan.'}, {'ForeName': 'Sawako', 'Initials': 'S', 'LastName': 'Yoshiuchi', 'Affiliation': 'Health Science Center, Kansai Medical University, Osaka, Japan.'}, {'ForeName': 'Aya', 'Initials': 'A', 'LastName': 'Fujii', 'Affiliation': 'Health Science Center, Kansai Medical University, Osaka, Japan.'}, {'ForeName': 'Yutaka', 'Initials': 'Y', 'LastName': 'Kimura', 'Affiliation': 'Department of Health Science, Kansai Medical University, Osaka, Japan.'}]","Diabetes, metabolic syndrome and obesity : targets and therapy",['10.2147/DMSO.S248769'] 2448,32606906,Effect of Intravenous Lidocaine on Postoperative Pain in Patients Undergoing Intraspinal Tumor Resection: Study Protocol for a Prospective Randomized Controlled Trial.,"Purpose Patients undergoing intraspinal tumor resection usually experience severe acute pain, delaying postoperative rehabilitation, and increasing incidence of chronic pain. Recently, an increasing number of studies have found that low-dose intravenous lidocaine infusion during and/or after surgery can reduce opioid usage and the incidence of related side effects, inhibit hyperalgesia and promote recovery. Thus far, no studies have evaluated the analgesic effect and safety of perioperative intravenous lidocaine infusion for intraspinal tumor resection, especially the long-term analgesic effects of patient-controlled analgesia (PCA) with lidocaine during the first postoperative 48 hours. This study tests the hypothesis that intra- and postoperative systemic lidocaine infusion for patients undergoing intraspinal tumor resection can relieve postoperative acute or chronic pain and reduce the opioid dosage and incidence of related side effects without other problems. Study Design and Methods This is a prospective, randomized, placebo-controlled, and double-blinded study. In total, 180 participants scheduled for intraspinal tumor resection will be randomly divided into lidocaine and placebo groups. The lidocaine group will be administered lidocaine intravenously during anesthesia and postoperative pain management during the first 48 postoperative hours; the placebo group will be administered normal saline at the same volume, infusion rate, and timing. The primary outcome will be the postoperative visual analog scale (VAS) score. Secondary outcomes will be postoperative cumulative sufentanil consumption, indicators of postoperative recovery, and the incidence of perioperative adverse events. Discussion This study investigates the effect of continuous intravenous lidocaine infusion on postoperative sufentanil consumption and VAS scores. The findings will provide a new strategy of anesthesia and analgesia management for intraspinal tumor resection.",2020,"Thus far, no studies have evaluated the analgesic effect and safety of perioperative intravenous lidocaine infusion for intraspinal tumor resection, especially the long-term analgesic effects of patient-controlled analgesia (PCA) with lidocaine during the first postoperative 48 hours.","['180 participants scheduled for intraspinal tumor resection', 'Patients Undergoing Intraspinal Tumor Resection', 'Patients undergoing intraspinal tumor resection usually experience severe acute pain', 'patients undergoing intraspinal tumor resection']","['Intravenous Lidocaine', 'lidocaine and placebo', 'lidocaine', 'placebo']","['postoperative visual analog scale (VAS) score', 'Postoperative Pain', 'postoperative cumulative sufentanil consumption, indicators of postoperative recovery, and the incidence of perioperative adverse events', 'postoperative sufentanil consumption and VAS scores']","[{'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C1283188', 'cui_str': 'Intraspinal'}, {'cui': 'C4761063', 'cui_str': 'Tumor resection'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0184567', 'cui_str': 'Acute pain'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0143993', 'cui_str': 'Sufentanil'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}]",180.0,0.229149,"Thus far, no studies have evaluated the analgesic effect and safety of perioperative intravenous lidocaine infusion for intraspinal tumor resection, especially the long-term analgesic effects of patient-controlled analgesia (PCA) with lidocaine during the first postoperative 48 hours.","[{'ForeName': 'Hongli', 'Initials': 'H', 'LastName': 'Yue', 'Affiliation': ""Department of Anesthesiology, Beijing Tian Tan Hospital, Capital Medical University, Beijing, People's Republic of China.""}, {'ForeName': 'Man', 'Initials': 'M', 'LastName': 'Zhou', 'Affiliation': ""Department of Anesthesiology, Beijing Tian Tan Hospital, Capital Medical University, Beijing, People's Republic of China.""}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Lu', 'Affiliation': ""Department of Anesthesiology, Beijing Tian Tan Hospital, Capital Medical University, Beijing, People's Republic of China.""}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': ""Department of Anesthesiology, Beijing Tian Tan Hospital, Capital Medical University, Beijing, People's Republic of China.""}, {'ForeName': 'Weihua', 'Initials': 'W', 'LastName': 'Cui', 'Affiliation': ""Department of Anesthesiology, Beijing Tian Tan Hospital, Capital Medical University, Beijing, People's Republic of China.""}]",Journal of pain research,['10.2147/JPR.S249359'] 2449,32606914,"A Randomized, Open-Label, Bioequivalence Study of Lidocaine Topical System 1.8% and Lidocaine Patch 5% in Healthy Subjects.","Purpose This study was designed to characterize drug delivery with lidocaine topical system 1.8% vs lidocaine patch 5% through 2 PK studies. Patients and Methods Two Phase 1, single-center, open-label, randomized PK studies were performed in healthy adults. In Study 1, 56 subjects received a single intravenous bolus of 0.7 mg/kg of lidocaine as a lead-in to allow for the accurate determination of apparent dose of both products. After a 7-day washout period, subjects were randomized to receive either lidocaine topical system 1.8% or lidocaine patch 5% for 12 hours followed by another 7-day washout period, after which subjects crossed over to receive the other treatment for 12 hours. In Study 2, 54 subjects were randomized to receive either lidocaine topical system 1.8% or lidocaine patch 5% for 12 hours. After a 7-day washout period, subjects crossed over to receive the other treatment. Adhesion and skin irritation assessments were performed after application of the products in Study 2. In both studies, serial blood samples were collected to measure the plasma concentration of lidocaine after product application. Safety assessments and adverse events were monitored in both studies. Results The comparative PK analysis demonstrated that the two products, despite their difference in drug load and strength, are bioequivalent. Both products were well tolerated. In Study 2, dermal response scores (skin tolerability after removal) were similar between lidocaine topical system 1.8% and lidocaine patch 5%, with a mean irritation score per patch <1 (barely perceptible erythema), which is not considered to be clinically significant. Conclusion Bioequivalence was demonstrated between lidocaine topical system 1.8% and lidocaine patch 5%. A comparison of the single-time adhesion scores at 12 hours in Study 2 favored lidocaine topical system 1.8% over lidocaine patch 5%. Both products were well tolerated as a single application in healthy adult human subjects. ClinicalTrialsgov NCT04144192, NCT04149938.",2020,"In Study 2, dermal response scores (skin tolerability after removal) were similar between lidocaine topical system 1.8% and lidocaine patch 5%, with a mean irritation score per patch <1 (barely perceptible erythema), which is not considered to be clinically significant. ","['56 subjects', '54 subjects', 'healthy adults', 'Healthy Subjects', 'healthy adult human subjects']","['lidocaine topical system 1.8% or lidocaine patch', 'lidocaine', 'lidocaine topical system 1.8% vs lidocaine patch', 'Lidocaine Topical System 1.8% and Lidocaine Patch']","['tolerated', 'dermal response scores (skin tolerability', 'Adhesion and skin irritation assessments', 'Safety assessments and adverse events', 'mean irritation score']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0080105', 'cui_str': 'Human Subjects'}]","[{'cui': 'C0360097', 'cui_str': 'Lidocaine-containing product in cutaneous dose form'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C4068742', 'cui_str': '1.8'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0332461', 'cui_str': 'Plaque'}]","[{'cui': 'C1522447', 'cui_str': 'Cutaneous route'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0001511', 'cui_str': 'Adhesion'}, {'cui': 'C0152030', 'cui_str': 'Skin irritation'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0441723', 'cui_str': 'Irritation'}]",,0.0240523,"In Study 2, dermal response scores (skin tolerability after removal) were similar between lidocaine topical system 1.8% and lidocaine patch 5%, with a mean irritation score per patch <1 (barely perceptible erythema), which is not considered to be clinically significant. ","[{'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Gudin', 'Affiliation': 'Department of Anesthesiology, Englewood Hospital and Medical Center, Englewood, NJ, USA.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Argoff', 'Affiliation': 'Department of Neurology, Albany Medical Center, Albany, NY, USA.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Fudin', 'Affiliation': 'Professional Practice, Albany College of Pharmacy and Health Sciences, Albany, NY, USA.'}, {'ForeName': 'Emileigh', 'Initials': 'E', 'LastName': 'Greuber', 'Affiliation': 'Scilex Pharmaceuticals Inc., Palo Alto, CA, USA.'}, {'ForeName': 'Kip', 'Initials': 'K', 'LastName': 'Vought', 'Affiliation': 'Scilex Pharmaceuticals Inc., Palo Alto, CA, USA.'}, {'ForeName': 'Kalpana', 'Initials': 'K', 'LastName': 'Patel', 'Affiliation': 'Scilex Pharmaceuticals Inc., Palo Alto, CA, USA.'}, {'ForeName': 'Sri', 'Initials': 'S', 'LastName': 'Nalamachu', 'Affiliation': 'Mid America PolyClinic, Overland Park, KS, USA.'}]",Journal of pain research,['10.2147/JPR.S237934'] 2450,32606956,Icotinib as Adjuvant Treatment for Stage II-IIIA Lung Adenocarcinoma Patients with EGFR Mutation (ICWIP Study): Study Protocol for a Randomised Controlled Trial.,"The efficacy and possible role of epidermal growth factor receptor tyrosine kinase inhibitors in treating early-stage non-small-cell lung cancer have yet to be established. Therefore, we aimed to explore the efficacy and safety of icotinib in completely resected EGFR-mutant stage II-IIIA lung adenocarcinoma patients who underwent standard chemotherapy. This is a randomised, double-blinded, placebo-controlled, multicentre, Phase III trial. A total of 124 patients aged 18-75 years who qualified the inclusion criteria were recruited. These patients were randomised (1:1) to receive either icotinib (125 mg 3 times per day) or placebo (the same dosage and frequency) for 36 months, followed by a further 36 months of observational window. The primary endpoint is disease-free survival (DFS), while the secondary endpoints are overall survival, 3-year and 5-year DFS, safety and tolerability of the medication, and health-related quality-of-life. Analyses will be conducted in a full analysis set and a per-protocol set as well. To our knowledge, the present study is the first randomised, double-blinded, placebo-controlled, multicenter trial designed to explore efficacy and safety of icotonib in this population. The results obtained in the near future may provide potential guidance in clinical practice. Trial Registration: This trial was registered on www.ClinicalTrail.gov as NCT02125240.",2020,"The primary endpoint is disease-free survival (DFS), while the secondary endpoints are overall survival, 3-year and 5-year DFS, safety and tolerability of the medication, and health-related quality-of-life.","['124 patients aged 18-75 years who qualified the inclusion criteria were recruited', 'Stage II-IIIA Lung Adenocarcinoma Patients with EGFR Mutation (ICWIP Study']","['epidermal growth factor receptor tyrosine kinase inhibitors', 'standard chemotherapy', 'icotinib', 'placebo']","['efficacy and safety', 'overall survival, 3-year and 5-year DFS, safety and tolerability of the medication, and health-related quality-of-life', 'disease-free survival (DFS']","[{'cui': 'C4517553', 'cui_str': '124'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2'}, {'cui': 'C0152013', 'cui_str': 'Adenocarcinoma of lung'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C1443775', 'cui_str': 'Epidermal growth factor receptor antagonist-containing product'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C2604307', 'cui_str': 'icotinib'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0242793', 'cui_str': 'Survival, Disease-Free'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",124.0,0.722716,"The primary endpoint is disease-free survival (DFS), while the secondary endpoints are overall survival, 3-year and 5-year DFS, safety and tolerability of the medication, and health-related quality-of-life.","[{'ForeName': 'Yu-Tao', 'Initials': 'YT', 'LastName': 'Liu', 'Affiliation': ""Department of Medical Oncology, Beijing Key Laboratory of Clinical Study on Anticancer Molecular Targeted Drugs, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, People's Republic of China.""}, {'ForeName': 'Xue-Zhi', 'Initials': 'XZ', 'LastName': 'Hao', 'Affiliation': ""Department of Medical Oncology, Beijing Key Laboratory of Clinical Study on Anticancer Molecular Targeted Drugs, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, People's Republic of China.""}, {'ForeName': 'De-Ruo', 'Initials': 'DR', 'LastName': 'Liu', 'Affiliation': ""Department of General Thoracic Surgery, China-Japan Friendship Hospital, Beijing, People's Republic of China.""}, {'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Cheng', 'Affiliation': ""Department of Medical Oncology, Beijing Hospital, Beijing, People's Republic of China.""}, {'ForeName': 'Shu-Cai', 'Initials': 'SC', 'LastName': 'Zhang', 'Affiliation': ""Beijing Chest Hospital, Capital Medical University/Beijing Tuberculosis and Thoracic Tumor Research Institute, Beijing, People's Republic of China.""}, {'ForeName': 'Wen-Hua', 'Initials': 'WH', 'LastName': 'Xiao', 'Affiliation': ""Department of Oncology, The First Affiliated Hospital of Chinese PLA General Hospital, Beijing, People's Republic of China.""}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': ""Department of Oncology, Chinese PLA General Hospital, Beijing, People's Republic of China.""}, {'ForeName': 'Jun-Feng', 'Initials': 'JF', 'LastName': 'Liu', 'Affiliation': ""Department of Thoracic Surgery, The Fourth Hospital of Hebei Medical University, Shijiazhuang, Hebei, People's Republic of China.""}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'He', 'Affiliation': ""Department of Thoracic Surgery, The Fourth Hospital of Hebei Medical University, Shijiazhuang, Hebei, People's Republic of China.""}, {'ForeName': 'Cui-Min', 'Initials': 'CM', 'LastName': 'Ding', 'Affiliation': ""Department of Respiratory Medicine, The Fourth Hospital of Hebei Medical University, Shijiazhuang, Hebei, People's Republic of China.""}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': ""Department of Respiratory Medicine, Peking Union Medical College Hospital, Affiliated to Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, People's Republic of China.""}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': ""Department of Thoracic Surgery, Peking University People's Hospital, Beijing, People's Republic of China.""}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': ""Department of Thoracic Surgery, Beijing Chaoyang Hospital Affiliated to Capital Medical University, Beijing, People's Republic of China.""}, {'ForeName': 'Gui-Lan', 'Initials': 'GL', 'LastName': 'Dong', 'Affiliation': ""Department of Radiotherapy and Chemotherapy, Tangshan People's Hospital, Tangshan, Hebei, People's Republic of China.""}, {'ForeName': 'Xiu-Yi', 'Initials': 'XY', 'LastName': 'Zhi', 'Affiliation': ""Department of Thoracic Surgery, Xuanwu Hospital of Capital Medical University, Beijing, People's Republic of China.""}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': ""Department of Thoracic Surgery, Peking University First Hospital, Beijing, People's Republic of China.""}, {'ForeName': 'Yuan-Kai', 'Initials': 'YK', 'LastName': 'Shi', 'Affiliation': ""Department of Medical Oncology, Beijing Key Laboratory of Clinical Study on Anticancer Molecular Targeted Drugs, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, People's Republic of China.""}]",Cancer management and research,['10.2147/CMAR.S240275'] 2451,32607000,Effect of Delayed Cord Clamping at 30 Seconds and 1 Minute on Neonatal Hematocrit in Term Cesarean Delivery: A Randomized Trial.,"Objective To compare the effect of delayed cord clamping at 30 seconds and 1 minute on the incidence of neonatal hematocrit, anemia, maternal and neonatal complications in term cesarean delivered neonates. Methods An opened labelled, randomized controlled trial was undertaken. The 160 healthy term cesarean-born neonates were randomly allocated to either 30 seconds or 1-minute groups of delayed cord clamping (DCC) (groups 1 and 2). Neonatal venous hematocrit (Hct) and microbilirubin (Mb) were measured at 48-72 hours after birth. Results One hundred and fifty-nine neonates completed this study. Mean neonatal hematocrit ± standard deviation at 48-72 hours was 49.9 ± 6.0% in group 1 and 51.2 ± 5.9% in group 2 without a statistical difference. Neonatal anemia (Hct less than 45%) occurred in 14/79 neonates (17.7%) in group 1 and in 8/80 cases (10.0%) in group 2 without a significant difference between groups. The incidence of neonatal jaundice and polycythemia (hematocrit more than 65%) was similar between groups. There were no significant differences; in the estimated blood loss during the operation, the incidence of postpartum hemorrhage and other maternal and neonatal complications. Conclusion Neonatal hematocrit was not significantly different following DCC at 30 seconds and at 1 minute, but the incidence of neonatal anemia decreased with the longer timing of DCC. The estimated blood loss and other complications were not different between the two groups. Therefore, one minute-DCC should be considered for neonatal anemic prevention when compared with 30 seconds-DCC.",2020,"There were no significant differences; in the estimated blood loss during the operation, the incidence of postpartum hemorrhage and other maternal and neonatal complications. ","['One hundred and fifty-nine neonates completed this study', 'Term Cesarean Delivery', '160 healthy term cesarean-born neonates', 'term cesarean delivered neonates']","['30 seconds or 1-minute groups of delayed cord clamping (DCC) ', 'Delayed Cord Clamping', 'delayed cord clamping']","['neonatal hematocrit, anemia, maternal and neonatal complications', 'estimated blood loss and other complications', 'Neonatal anemia', 'neonatal jaundice and polycythemia (hematocrit', 'Neonatal Hematocrit', 'estimated blood loss', 'incidence of postpartum hemorrhage and other maternal and neonatal complications', 'neonatal anemia', 'Neonatal hematocrit', 'Mean neonatal hematocrit ± standard deviation', 'Neonatal venous hematocrit (Hct) and microbilirubin (Mb']","[{'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}]","[{'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C3489532', 'cui_str': 'Cone-Rod Dystrophy 2'}, {'cui': 'C0521213', 'cui_str': 'Clamping'}, {'cui': 'C0175721', 'cui_str': 'Clamp'}]","[{'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0018935', 'cui_str': 'Hematocrit determination'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C1443559', 'cui_str': 'Estimated blood loss'}, {'cui': 'C0002891', 'cui_str': 'Neonatal anemia'}, {'cui': 'C0022353', 'cui_str': 'Neonatal jaundice'}, {'cui': 'C0032461', 'cui_str': 'Polycythaemia'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0032797', 'cui_str': 'Postpartum hemorrhage'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0042449', 'cui_str': 'Venous structure'}]",160.0,0.157912,"There were no significant differences; in the estimated blood loss during the operation, the incidence of postpartum hemorrhage and other maternal and neonatal complications. ","[{'ForeName': 'Metha', 'Initials': 'M', 'LastName': 'Songthamwat', 'Affiliation': 'Department of Obstetrics and Gynecology, Udonthani Hospital, Udonthani, Thailand.'}, {'ForeName': 'Patthamon', 'Initials': 'P', 'LastName': 'Witsawapaisan', 'Affiliation': 'Department of Obstetrics and Gynecology, Udonthani Hospital, Udonthani, Thailand.'}, {'ForeName': 'Sopida', 'Initials': 'S', 'LastName': 'Tanthawat', 'Affiliation': 'Department of Pediatrics, Udonthani Hospital, Udonthani, Thailand.'}, {'ForeName': 'Srisuda', 'Initials': 'S', 'LastName': 'Songthamwat', 'Affiliation': 'Department of Obstetrics and Gynecology, Udonthani Hospital, Udonthani, Thailand.'}]",International journal of women's health,['10.2147/IJWH.S248709'] 2452,32607250,Active Women over 50 online information and support to promote physical activity behaviour change: study protocol for a pilot trial.,"Background Physical activity has many physical and mental health benefits and can delay the development of disability in older age. However, uptake of this health behaviour is sub-optimal in women in their middle and older age. This trial aims to establish the acceptability and feasibility of the Active Women over 50 programme involving online information, telephone health coaching and email or SMS support to promote physical activity behaviour change among women aged 50 years and over. Methods Sixty community-dwelling women who are insufficiently active according to national guidelines, will be recruited and randomised to 1) receive the Active Women over 50 programme or 2) a wait-list control. Active Women over 50 is a 3-month physical activity programme guided by behaviour change science, providing access to a website, one telephone-delivered health coaching session from a physiotherapist and 8 email or 24 SMS messages. The primary outcome is the proportion of participants at 3 months post-randomisation who would recommend participation in the programme to another person like themselves. Secondary outcomes are feasibility measures: rates of recruitment, retention, completeness of outcome data and uptake of telephone support; and intervention impact measures: accelerometer-assessed average steps/day, proportion of participants meeting national guidelines on moderate to vigorous physical activity; and questionnaire-assessed quality of life, exercise perceptions, mood, physical functioning and self-reported physical activity. Intervention participants will also complete a follow-up survey to assess impressions of the intervention and adoption of strategies for physical activity participation. Data will be analysed descriptively to guide the design of a larger trial. Between-group differences in secondary outcomes will be used to estimate effect sizes for sample size calculations for a fully powered randomised controlled trial. Discussion This feasibility pilot trial of an efficient eHealth and health coaching intervention guided by user input and behaviour change theory, will inform future interventions to address low physical activity participation among an under-active group at risk of future disability. Trial registration ANZCTR, ACTRN12619000490178, registered 26 March 2019.",2020,"This feasibility pilot trial of an efficient eHealth and health coaching intervention guided by user input and behaviour change theory, will inform future interventions to address low physical activity participation among an under-active group at risk of future disability. ","['women in their middle and older age', 'women aged 50\u2009years and over', 'Sixty community-dwelling women who are insufficiently active according to national guidelines']","['efficient eHealth and health coaching intervention', 'Active Women over 50 programme or 2) a wait-list control', '50 programme involving online information, telephone health coaching and email or SMS support']","['feasibility measures: rates of recruitment, retention, completeness of outcome data and uptake of telephone support; and intervention impact measures: accelerometer-assessed average steps/day, proportion of participants meeting national guidelines on moderate to vigorous physical activity; and questionnaire-assessed quality of life, exercise perceptions, mood, physical functioning and self-reported physical activity']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0231337', 'cui_str': 'Senility'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}]","[{'cui': 'C0442799', 'cui_str': 'Efficient'}, {'cui': 'C1328956', 'cui_str': 'eHealth'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0013849', 'cui_str': 'Email'}, {'cui': 'C0795864', 'cui_str': 'Smith-Magenis syndrome'}, {'cui': 'C0183683', 'cui_str': 'Support'}]","[{'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0439812', 'cui_str': 'Completeness'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0162791', 'cui_str': 'Guidelines as Topic'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}]",,0.196925,"This feasibility pilot trial of an efficient eHealth and health coaching intervention guided by user input and behaviour change theory, will inform future interventions to address low physical activity participation among an under-active group at risk of future disability. ","[{'ForeName': 'Geraldine', 'Initials': 'G', 'LastName': 'Wallbank', 'Affiliation': 'Institute for Musculoskeletal Health, School of Public Health, Faculty of Medicine and Health, The University of Sydney and Sydney Local Health District, PO Box M179, Missenden Road, Camperdown, 2050 Australia.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Sherrington', 'Affiliation': 'Institute for Musculoskeletal Health, School of Public Health, Faculty of Medicine and Health, The University of Sydney and Sydney Local Health District, PO Box M179, Missenden Road, Camperdown, 2050 Australia.'}, {'ForeName': 'Leanne', 'Initials': 'L', 'LastName': 'Hassett', 'Affiliation': 'Institute for Musculoskeletal Health, School of Public Health, Faculty of Medicine and Health, The University of Sydney and Sydney Local Health District, PO Box M179, Missenden Road, Camperdown, 2050 Australia.'}, {'ForeName': 'Dominika', 'Initials': 'D', 'LastName': 'Kwasnicka', 'Affiliation': 'Faculty of Health Sciences, School of Public Health, Curtin University, GPO Box U1987, Perth, WA 6845 Australia.'}, {'ForeName': 'Josephine Y', 'Initials': 'JY', 'LastName': 'Chau', 'Affiliation': 'Department of Health Systems and Population, Macquarie University, 75 Talavera Road, North Ryde, NSW 2109 Australia.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Martin', 'Affiliation': 'Department of Media and Communications, Faculty of Arts and Social Science, The University of Sydney, Camperdown, NSW 2006 Australia.'}, {'ForeName': 'Philayrath', 'Initials': 'P', 'LastName': 'Phongsavan', 'Affiliation': 'Charles Perkins Centre, Sydney School of Public Health, The University of Sydney, Camperdown, NSW 2006 Australia.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Grunseit', 'Affiliation': 'Charles Perkins Centre, Sydney School of Public Health, The University of Sydney, Camperdown, NSW 2006 Australia.'}, {'ForeName': 'Colleen', 'Initials': 'C', 'LastName': 'Canning', 'Affiliation': 'Discipline of Physiotherapy, Sydney School of Health Sciences, Faculty of Medicine and Health, The University of Sydney, PO Box 170, Lidcombe, NSW 1825 Australia.'}, {'ForeName': 'Marian', 'Initials': 'M', 'LastName': 'Baird', 'Affiliation': 'Discipline of Work and Organisational Studies, Sydney Business School, The University of Sydney, Camperdown, NSW 2006 Australia.'}, {'ForeName': 'Roberta', 'Initials': 'R', 'LastName': 'Shepherd', 'Affiliation': 'Discipline of Physiotherapy, Sydney School of Health Sciences, Faculty of Medicine and Health, The University of Sydney, PO Box 170, Lidcombe, NSW 1825 Australia.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Tiedemann', 'Affiliation': 'Institute for Musculoskeletal Health, School of Public Health, Faculty of Medicine and Health, The University of Sydney and Sydney Local Health District, PO Box M179, Missenden Road, Camperdown, 2050 Australia.'}]",Pilot and feasibility studies,['10.1186/s40814-020-00627-9'] 2453,32607385,"Occurrence of Host-Associated Fecal Markers on Child Hands, Household Soil, and Drinking Water in Rural Bangladeshi Households.","We evaluated whether provision and promotion of improved sanitation hardware (toilets and child feces management tools) reduced rotavirus and human fecal contamination of drinking water, child hands, and soil among rural Bangladeshi compounds enrolled in a cluster-randomized trial. We also measured host-associated genetic markers of ruminant and avian feces. We found evidence of widespread ruminant and avian fecal contamination in the compound environment; non-human fecal marker occurrence scaled with animal ownership. Strategies for controlling non- human fecal waste should be considered when designing interventions to reduce exposure to fecal contamination in low-income settings. Detection of a human- associated fecal marker and rotavirus was rare and unchanged by provision and promotion of improved sanitation to intervention compounds. The sanitation intervention reduced ruminant fecal contamination in drinking water and general (non-host specific) fecal contamination in soil but overall had limited effects on reducing fecal contamination in the household environment.",2016,The sanitation intervention reduced ruminant fecal contamination in drinking water and general (non-host specific) fecal contamination in soil but overall had limited effects on reducing fecal contamination in the household environment.,['Rural Bangladeshi Households'],"['sanitation intervention', 'provision and promotion of improved sanitation hardware (toilets and child feces management tools']",[],"[{'cui': 'C0422784', 'cui_str': 'Bangladeshi'}, {'cui': 'C0020052', 'cui_str': 'Households'}]","[{'cui': 'C0036172', 'cui_str': 'Sanitation'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0184958', 'cui_str': 'Toilet'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0336791', 'cui_str': 'Tool'}]",[],,0.0199364,The sanitation intervention reduced ruminant fecal contamination in drinking water and general (non-host specific) fecal contamination in soil but overall had limited effects on reducing fecal contamination in the household environment.,"[{'ForeName': 'Alexandria B', 'Initials': 'AB', 'LastName': 'Boehm', 'Affiliation': 'Department of Civil and Environmental Engineering, Stanford University, Stanford, California 94305, United States.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Wang', 'Affiliation': 'Department of Civil and Environmental Engineering, Stanford University, Stanford, California 94305, United States.'}, {'ForeName': 'Ayse', 'Initials': 'A', 'LastName': 'Ercumen', 'Affiliation': 'Division of Epidemiology, University of California, Berkeley, Berkeley, California 94720, United States.'}, {'ForeName': 'Meghan', 'Initials': 'M', 'LastName': 'Shea', 'Affiliation': 'Department of Civil and Environmental Engineering, Stanford University, Stanford, California 94305, United States.'}, {'ForeName': 'Angela R', 'Initials': 'AR', 'LastName': 'Harris', 'Affiliation': 'Department of Civil and Environmental Engineering, Stanford University, Stanford, California 94305, United States.'}, {'ForeName': 'Orin C', 'Initials': 'OC', 'LastName': 'Shanks', 'Affiliation': 'Office of Research & Development, U.S. Environmental Protection Agency, Cincinnati, Ohio 45268, United States.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Kelty', 'Affiliation': 'Office of Research & Development, U.S. Environmental Protection Agency, Cincinnati, Ohio 45268, United States.'}, {'ForeName': 'Alvee', 'Initials': 'A', 'LastName': 'Ahmed', 'Affiliation': 'International Center for Diarrheal Diseases Research, Bangladesh, Dhaka 1000, Bangladesh.'}, {'ForeName': 'Zahid Hayat', 'Initials': 'ZH', 'LastName': 'Mahmud', 'Affiliation': 'International Center for Diarrheal Diseases Research, Bangladesh, Dhaka 1000, Bangladesh.'}, {'ForeName': 'Benjamin F', 'Initials': 'BF', 'LastName': 'Arnold', 'Affiliation': 'Division of Epidemiology, University of California, Berkeley, Berkeley, California 94720, United States.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Chase', 'Affiliation': 'The World Bank, Washington, D.C. 20433, United States.'}, {'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Kullmann', 'Affiliation': 'The World Bank, Washington, D.C. 20433, United States.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Colford', 'Affiliation': 'Division of Epidemiology, University of California, Berkeley, Berkeley, California 94720, United States.'}, {'ForeName': 'Stephen P', 'Initials': 'SP', 'LastName': 'Luby', 'Affiliation': 'Woods Institute for the Environment, Stanford University, Stanford, California 94305, United States.'}, {'ForeName': 'Amy J', 'Initials': 'AJ', 'LastName': 'Pickering', 'Affiliation': 'Department of Civil and Environmental Engineering, Stanford University, Stanford, California 94305, United States.'}]",Environmental science & technology letters,[] 2454,32607502,"Project Khanya: a randomized, hybrid effectiveness-implementation trial of a peer-delivered behavioral intervention for ART adherence and substance use in Cape Town, South Africa.","Background Substance use is prevalent in South Africa and associated with poor HIV treatment outcomes, yet, it is largely unaddressed in HIV care. Implementing an evidence-based, task-shared intervention for antiretroviral therapy (ART) adherence and substance use integrated into HIV care may be a feasible and effective way to improve HIV treatment outcomes and reduce substance use in this population. Methods Guided by the RE-AIM framework, a randomized, hybrid type 1 effectiveness-implementation trial (n = 60) is being used to evaluate a peer-delivered intervention that integrates evidence-based intervention components, including Life-Steps (problem solving and motivational skills for HIV medication adherence), behavioral activation to increase alternative, substance-free rewarding activities in one's environment, and relapse prevention skills, including mindfulness. The comparison condition is enhanced standard of care, which includes facilitating a referral to a local substance use treatment clinic (Matrix). Participants are followed for a period of 6 months. Implementation outcomes are defined by Proctor's model for implementation and include mixed methods evaluations of feasibility, acceptability, and fidelity, and barriers and facilitators to implementation. Primary patient-level effectiveness outcomes are ART adherence (Wisepill) and substance use (WHO-ASSIST and urinalysis); viral load is an exploratory outcome. Discussion Results of this trial will provide important evidence as to whether peer delivery of an integrated intervention for ART adherence and substance use is feasible, acceptable, and effective. Implementation outcomes will provide important insight into using peers as an implementation strategy to extend task sharing models for behavioral health in resource-limited settings globally. Trial registration ClinicalTrials.gov identifier: NCT03529409. Trial registered on May 18, 2018.",2020,"Implementing an evidence-based, task-shared intervention for antiretroviral therapy (ART) adherence and substance use integrated into HIV care may be a feasible and effective way to improve HIV treatment outcomes and reduce substance use in this population. ","['Cape Town, South Africa']","['peer-delivered behavioral intervention', 'peer-delivered intervention that integrates evidence-based intervention components, including Life-Steps (problem solving and motivational skills']","['feasibility, acceptability, and fidelity, and barriers and facilitators to implementation', 'ART adherence (Wisepill) and substance use (WHO-ASSIST and urinalysis); viral load is an exploratory outcome']","[{'cui': 'C0054434', 'cui_str': 'caffeic acid phenethyl ester'}, {'cui': 'C0557750', 'cui_str': 'Town environment'}, {'cui': 'C0037712', 'cui_str': 'South Africa'}]","[{'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0033211', 'cui_str': 'Problem solving'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0042014', 'cui_str': 'Urinalysis'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.149832,"Implementing an evidence-based, task-shared intervention for antiretroviral therapy (ART) adherence and substance use integrated into HIV care may be a feasible and effective way to improve HIV treatment outcomes and reduce substance use in this population. ","[{'ForeName': 'Jessica F', 'Initials': 'JF', 'LastName': 'Magidson', 'Affiliation': 'Department of Psychology, University of Maryland, 4094 Campus Drive, College Park, MD, USA.'}, {'ForeName': 'John A', 'Initials': 'JA', 'LastName': 'Joska', 'Affiliation': 'HIV Mental Health Research Unit, Division of Neuropsychiatry, Department of Psychiatry and Mental Health, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Bronwyn', 'Initials': 'B', 'LastName': 'Myers', 'Affiliation': 'Alcohol, Tobacco and Other Drug Research Unit, South African Medical Research Council, Cape Town, South Africa.'}, {'ForeName': 'Jennifer M', 'Initials': 'JM', 'LastName': 'Belus', 'Affiliation': 'Department of Psychology, University of Maryland, 4094 Campus Drive, College Park, MD, USA.'}, {'ForeName': 'Kristen S', 'Initials': 'KS', 'LastName': 'Regenauer', 'Affiliation': 'Department of Psychology, University of Maryland, 4094 Campus Drive, College Park, MD, USA.'}, {'ForeName': 'Lena S', 'Initials': 'LS', 'LastName': 'Andersen', 'Affiliation': 'HIV Mental Health Research Unit, Division of Neuropsychiatry, Department of Psychiatry and Mental Health, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Sybil', 'Initials': 'S', 'LastName': 'Majokweni', 'Affiliation': 'HIV Mental Health Research Unit, Division of Neuropsychiatry, Department of Psychiatry and Mental Health, University of Cape Town, Cape Town, South Africa.'}, {'ForeName': 'Conall', 'Initials': 'C', 'LastName': ""O'Cleirigh"", 'Affiliation': 'Department of Psychiatry, Massachusetts General Hospital/Harvard Medical School, Boston, USA.'}, {'ForeName': 'Steven A', 'Initials': 'SA', 'LastName': 'Safren', 'Affiliation': 'Department of Psychology, University of Miami, Coral Gables, USA.'}]",Implementation science communications,['10.1186/s43058-020-00004-w'] 2455,32607557,"Effect of daily vitamin B-12 and folic acid supplementation on fracture incidence in elderly individuals with an elevated plasma homocysteine concentration: B-PROOF, a randomized controlled trial.",,2020,,['elderly individuals with an elevated plasma homocysteine concentration'],['daily vitamin B-12 and folic acid supplementation'],['fracture incidence'],"[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0019878', 'cui_str': 'Homocysteine'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0042845', 'cui_str': 'Vitamin B 12'}, {'cui': 'C0556110', 'cui_str': 'Folic acid supplement agent'}]","[{'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",,0.241614,,[],The American journal of clinical nutrition,['10.1093/ajcn/nqaa129'] 2456,32607569,Safety and Effectiveness of Early Oral Hydration in Patients After Cardiothoracic Surgery.,"BACKGROUND Patients fast after cardiothoracic surgery because of concerns for nausea, vomiting, dysphagia, and aspiration pneumonia; fasting, however, causes thirst, a distressing symptom. To our knowledge, no studies exist to guide hydration practices in this population. OBJECTIVE To determine the effect of early oral hydration on adverse events and thirst in patients after cardiothoracic surgery. METHODS This study applied a prospective 2-group design in which 149 patients from an 18-bed cardiothoracic intensive care unit were randomized to either usual care (a 6-hour fast) or early oral hydration after extubation. The research protocol involved nurses evaluating patients' readiness for oral hydration and then offering them ice chips. If patients tolerated the ice chips, they were allowed to drink water 1 hour later. RESULTS Most patients (91.3%) had undergone coronary artery or valve surgery, or both. Demographic and clinical variables were similar in both groups. No significant between-group differences were found for the incidence of nausea, vomiting, or dysphagia, and no aspiration pneumonia occurred. Significantly more patients with a high thirst level were in the usual care group (81.2%) than in the early oral hydration group (56.5%; P = .002, r2 test). After adjustment for demographic and clinical variables by using logistic regression, early oral hydration was independently and negatively associated with a high thirst level (odds ratio, 0.30 [95% CI, 0.13-0.69]; P = .004). CONCLUSION This research provides new evidence that oral hydration (ice chips and water) soon after extubation is safe and significantly reduces thirst in particular patients.",2020,"No significant between-group differences were found for the incidence of nausea, vomiting, or dysphagia, and no aspiration pneumonia occurred.","['149 patients from an 18-bed cardiothoracic intensive care unit', 'Patients', 'patients after cardiothoracic surgery']","['usual care (a 6-hour fast) or early oral hydration after extubation', 'Early Oral Hydration']","['incidence of nausea, vomiting, or dysphagia, and no aspiration pneumonia', 'undergone coronary artery or valve surgery', 'Safety and Effectiveness']","[{'cui': 'C5191071', 'cui_str': '149'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004914', 'cui_str': 'Bedding'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C1274037', 'cui_str': 'Cardiothoracic surgery'}]","[{'cui': 'C1292428', 'cui_str': '6 hours'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C1321013', 'cui_str': 'Hydration status'}, {'cui': 'C0553891', 'cui_str': 'Extubation of trachea'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0011168', 'cui_str': 'Dysphagia'}, {'cui': 'C0032290', 'cui_str': 'Aspiration pneumonia'}, {'cui': 'C0205042', 'cui_str': 'Coronary artery structure'}, {'cui': 'C0018826', 'cui_str': 'Cardiac valve structure'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",149.0,0.0365417,"No significant between-group differences were found for the incidence of nausea, vomiting, or dysphagia, and no aspiration pneumonia occurred.","[{'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Ford', 'Affiliation': 'About the Authors: Catherine Ford and Donna McCormick are clinical nurses; Katrien Derycke-Chapman, Judith Marshall, Jessica Mancarella, and Anne Chepulis are former clinical nurses in the cardiothoracic intensive care unit, Heart and Vascular Center, Yale New Haven Hospital, New Haven, Connecticut.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'McCormick', 'Affiliation': 'About the Authors: Catherine Ford and Donna McCormick are clinical nurses; Katrien Derycke-Chapman, Judith Marshall, Jessica Mancarella, and Anne Chepulis are former clinical nurses in the cardiothoracic intensive care unit, Heart and Vascular Center, Yale New Haven Hospital, New Haven, Connecticut.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Parkosewich', 'Affiliation': 'About the Authors: Catherine Ford and Donna McCormick are clinical nurses; Katrien Derycke-Chapman, Judith Marshall, Jessica Mancarella, and Anne Chepulis are former clinical nurses in the cardiothoracic intensive care unit, Heart and Vascular Center, Yale New Haven Hospital, New Haven, Connecticut.'}, {'ForeName': 'Katrien', 'Initials': 'K', 'LastName': 'Derycke-Chapman', 'Affiliation': 'About the Authors: Catherine Ford and Donna McCormick are clinical nurses; Katrien Derycke-Chapman, Judith Marshall, Jessica Mancarella, and Anne Chepulis are former clinical nurses in the cardiothoracic intensive care unit, Heart and Vascular Center, Yale New Haven Hospital, New Haven, Connecticut.'}, {'ForeName': 'Judith', 'Initials': 'J', 'LastName': 'Marshall', 'Affiliation': 'About the Authors: Catherine Ford and Donna McCormick are clinical nurses; Katrien Derycke-Chapman, Judith Marshall, Jessica Mancarella, and Anne Chepulis are former clinical nurses in the cardiothoracic intensive care unit, Heart and Vascular Center, Yale New Haven Hospital, New Haven, Connecticut.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Mancarella', 'Affiliation': 'About the Authors: Catherine Ford and Donna McCormick are clinical nurses; Katrien Derycke-Chapman, Judith Marshall, Jessica Mancarella, and Anne Chepulis are former clinical nurses in the cardiothoracic intensive care unit, Heart and Vascular Center, Yale New Haven Hospital, New Haven, Connecticut.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Chepulis', 'Affiliation': 'About the Authors: Catherine Ford and Donna McCormick are clinical nurses; Katrien Derycke-Chapman, Judith Marshall, Jessica Mancarella, and Anne Chepulis are former clinical nurses in the cardiothoracic intensive care unit, Heart and Vascular Center, Yale New Haven Hospital, New Haven, Connecticut.'}]","American journal of critical care : an official publication, American Association of Critical-Care Nurses",['10.4037/ajcc2020841'] 2457,32607574,Relationship Between Intensive Care Unit Delirium Severity and 2-Year Mortality and Health Care Utilization.,"BACKGROUND Critical care patients with delirium are at an increased risk of functional decline and mortality long term. OBJECTIVE To determine the relationship between delirium severity in the intensive care unit and mortality and acute health care utilization within 2 years after hospital discharge. METHODS A secondary data analysis of the Pharmacological Management of Delirium and Deprescribe randomized controlled trials. Patients were assessed twice daily for delirium or coma using the Richmond Agitation-Sedation Scale and the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU). Delirium severity was measured using the CAM-ICU-7. Mean delirium severity (from time of randomization to discharge) was categorized as rapidly resolving, mild to moderate, or severe. Cox proportional hazards regression was used to model time to death, first emergency department visit, and rehospitalization. Analyses were adjusted for age, sex, race, Charlson Comorbidity Index, Acute Physiology and Chronic Health Evaluation II score, discharge location, diagnosis, and intensive care unit type. RESULTS Of 434 patients, those with severe delirium had higher mortality risk than those with rapidly resolving delirium (hazard ratio 2.21; 95% CI, 1.35-3.61). Those with 5 or more days of delirium or coma had higher mortality risk than those with less than 5 days (hazard ratio 1.52; 95% CI, 1.07-2.17). Delirium severity and number of days of delirium or coma were not associated with time to emergency department visits and rehospitalizations. CONCLUSION Increased delirium severity and days of delirium or coma are associated with higher mortality risk 2 years after discharge.",2020,"Delirium severity and number of days of delirium or coma were not associated with time to emergency department visits and rehospitalizations. ",[],[],"['mortality risk', 'Mean delirium severity', 'Delirium severity and number of days of delirium or coma', 'Delirium severity', 'delirium or coma using the Richmond Agitation-Sedation Scale']",[],[],"[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0009421', 'cui_str': 'Coma'}, {'cui': 'C4720839', 'cui_str': 'Richmond agitation-sedation scale'}]",434.0,0.192125,"Delirium severity and number of days of delirium or coma were not associated with time to emergency department visits and rehospitalizations. ","[{'ForeName': 'Patricia S', 'Initials': 'PS', 'LastName': 'Andrews', 'Affiliation': 'About the Authors: Patricia S. Andrews is an assistant professor, Department of Psychiatry and Behavioral Sciences, Vanderbilt University Medical Center, Nashville, Tennessee.'}, {'ForeName': 'Sophia', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'Sophia Wang is an assistant professor, Department of Psychiatry, Indiana University School of Medicine, Indianapolis, Indiana.'}, {'ForeName': 'Anthony J', 'Initials': 'AJ', 'LastName': 'Perkins', 'Affiliation': 'Anthony J. Perkins is a staff biostatistician, Department of Biostatistics, Indiana University School of Medicine.'}, {'ForeName': 'Sujuan', 'Initials': 'S', 'LastName': 'Gao', 'Affiliation': 'Sujuan Gao is a professor, Department of Biostatistics, Indiana University School of Medicine.'}, {'ForeName': 'Sikandar', 'Initials': 'S', 'LastName': 'Khan', 'Affiliation': 'Sikandar Khan is an assistant professor, Division of Pulmonary, Critical Care, Sleep and Occupational Medicine, Department of Medicine, Indiana University School of Medicine; and a research scientist, Indiana University Center for Aging Research, Regenstrief Institute, Indianapolis, Indiana.'}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Lindroth', 'Affiliation': 'Heidi Lindroth is a postdoctoral fellow, Division of Pulmonary, Critical Care, Sleep and Occupational Medicine, Department of Medicine, Indiana University School of Medicine; and an affiliate at the Indiana University Center for Aging Research, Regenstrief Institute.'}, {'ForeName': 'Malaz', 'Initials': 'M', 'LastName': 'Boustani', 'Affiliation': 'Malaz Boustani is a professor, Department of Medicine, Indiana University School of Medicine; the founding director, Center for Health Innovation and Implementation Science at Indiana Clinical Translational Science Institute; director of senior care innovation, Eskenazi Hospital; and a research scientist, Indiana University Center for Aging Research, Regen strief Institute.'}, {'ForeName': 'Babar', 'Initials': 'B', 'LastName': 'Khan', 'Affiliation': 'Babar Khan is an associate professor, Division of Pulmonary, Critical Care, Sleep and Occupational Medicine, Department of Medicine, Indiana University School of Medicine; and a research scientist, Indiana University Center for Aging Research, Regenstrief Institute.'}]","American journal of critical care : an official publication, American Association of Critical-Care Nurses",['10.4037/ajcc2020498'] 2458,32607598,Neu-horizons: neuroprotection and therapeutic use of riluzole for the prevention of oxaliplatin-induced neuropathy-a randomised controlled trial.,"TRIAL DESIGN Peripheral neuropathy is a commonly reported adverse effect of oxaliplatin treatment, representing a significant limitation which may require discontinuation of effective therapy. The present study investigated the neuroprotective potential of riluzole in patients undergoing oxaliplatin treatment in a randomised-controlled trial comparing riluzole and placebo-control. METHODS Fifty-two patients (17 females, 58.1 ± 12.7 years) receiving oxaliplatin treatment were randomised into either a treatment (50 mg riluzole) or lactose placebo group. The primary outcome measure was the total neuropathy score-reduced (TNSr). Secondary outcome measures include nerve excitability measures, 9-hole pegboard and FACT-GOG NTX questionnaire. Patients were assessed at baseline, pre-cycle 10 or 12, 4-week and 12-week post-treatment. RESULTS Both the treatment and placebo groups developed objective and patient reported evidence of neurotoxicity over the course of oxaliplatin treatment, although there were no significant differences across any parameters between the two groups. However, across follow-up assessments, the treatment group experienced greater neuropathy, represented by a higher TNSr score at 4-week post-chemotherapy of 8.3 ± 2.7 compared with 4.6 ± 3.6 (p = 0.032) which was sustained at 12-week post-treatment (p = 0.089). Similarly, patients in the treatment group reported worse symptoms with a FACT-GOG NTX score of 37.4 ± 10.2 compared with 43.3 ± 7.4 (p = 0.02) in the placebo group at 4-week post-treatment. CONCLUSION This study is the first to provide an objective clinical investigation of riluzole in oxaliplatin-induced peripheral neuropathy employing both functional and neurophysiological measures. Although the recruitment target was not reached, the results do not show any benefit of riluzole in minimising neuropathy and may suggest that riluzole worsens neuropathy associated with oxaliplatin treatment.",2020,"However, across follow-up assessments, the treatment group experienced greater neuropathy, represented by a higher TNSr score at 4-week post-chemotherapy of 8.3 ± 2.7 compared with 4.6 ± 3.6 (p = 0.032) which was sustained at 12-week post-treatment (p = 0.089).","['patients undergoing', 'Fifty-two patients (17 females, 58.1\u2009±\u200912.7\xa0years) receiving']","['oxaliplatin', 'riluzole', 'riluzole) or lactose placebo', 'riluzole and placebo-control', 'placebo']","['TNSr score', 'neurotoxicity', 'nerve excitability measures, 9-hole pegboard and FACT-GOG NTX questionnaire', 'total neuropathy score-reduced (TNSr', 'worse symptoms with a FACT-GOG NTX score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4319570', 'cui_str': '52'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517546', 'cui_str': '12.7'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0073379', 'cui_str': 'Riluzole'}, {'cui': 'C0022949', 'cui_str': 'Lactose'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C4727882', 'cui_str': 'Total neuropathy score'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0235032', 'cui_str': 'Neurotoxicity'}, {'cui': 'C0000741', 'cui_str': 'Abducens nerve structure'}, {'cui': 'C0235169', 'cui_str': 'Excitability'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0285526', 'cui_str': 'N-telopeptide'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",52.0,0.210382,"However, across follow-up assessments, the treatment group experienced greater neuropathy, represented by a higher TNSr score at 4-week post-chemotherapy of 8.3 ± 2.7 compared with 4.6 ± 3.6 (p = 0.032) which was sustained at 12-week post-treatment (p = 0.089).","[{'ForeName': 'Terry', 'Initials': 'T', 'LastName': 'Trinh', 'Affiliation': 'Prince of Wales Clinical School, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Susanna B', 'Initials': 'SB', 'LastName': 'Park', 'Affiliation': 'Brain and Mind Centre, University of Sydney, Sydney, Australia.'}, {'ForeName': 'Jenna', 'Initials': 'J', 'LastName': 'Murray', 'Affiliation': 'Prince of Wales Clinical School, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Pickering', 'Affiliation': 'Prince of Wales Clinical School, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Cindy S-Y', 'Initials': 'CS', 'LastName': 'Lin', 'Affiliation': 'Brain and Mind Centre, University of Sydney, Sydney, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Martin', 'Affiliation': 'National Health and Medical Research Centre Clinical Trials Centre, University of Sydney, Sydney, Australia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Friedlander', 'Affiliation': 'Department of Medical Oncology, Prince of Wales Hospital, Randwick, Sydney, Australia.'}, {'ForeName': 'Matthew C', 'Initials': 'MC', 'LastName': 'Kiernan', 'Affiliation': 'Brain and Mind Centre, University of Sydney, Sydney, Australia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Goldstein', 'Affiliation': 'Prince of Wales Clinical School, University of New South Wales, Sydney, Australia.'}, {'ForeName': 'Arun V', 'Initials': 'AV', 'LastName': 'Krishnan', 'Affiliation': 'Prince of Wales Clinical School, University of New South Wales, Sydney, Australia. arun.krishnan@unsw.edu.au.'}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-020-05591-x'] 2459,32607644,Subclinical affective and cognitive fluctuations in Parkinson's disease: a randomized double-blind double-dummy study of Oral vs. Intrajejunal Levodopa.,"BACKGROUND Chronic levodopa treatment in Parkinson's disease (PD) may promote undesirable motor and non-motor fluctuations. Compared to chronic oral levodopa treatment, continuous infusion of levodopa/carbidopa intestinal gel (LCIG) in advanced PD reduces motor fluctuations. However, differences in their effect on acute non-motor changes were not formally demonstrated. OBJECTIVE We performed a randomized, double-blind, double-dummy, crossover study to compare acute non-motor changes between intermittent oral immediate-release carbidopa/levodopa (LC-IR) and LCIG. METHODS After > 12-h OFF, thirteen PD patients chronically treated with LCIG and without history of non-motor swings, were allocated to receive first, LCIG infusion plus three oral doses of placebo, or placebo infusion plus three oral doses of LC-IR. Over-encapsulated oral medication (LC-IR or placebo) was administered every 2 h. We monitored plasmatic levels of levodopa, motor status (UPDRS-III), mood, anxiety, and frontal functions at baseline (0-h) and hourly after each oral challenge. RESULTS Repeated-measures ANOVAs showed significant group by treatment interaction indicating more fluctuations of levodopa plasma levels with LC-IR. No significant interactions were seen in the temporal profile of motor status, anxiety, mood and cognition. However, point-to-point parametric and nonparametric tests showed a significant more marked and more sustained improvement in anxiety scores under LCIG. A significant improvement of mood and verbal fluency was seen a + 3-h only under LCIG. DISCUSSION Our sample of advanced PD patients exhibited moderate but significant non-motor fluctuations. LCIG was associated with a more favorable profile of acute affective and cognitive fluctuations that was particularly expressed at the first part of the infusion curve.",2020,"However, point-to-point parametric and nonparametric tests showed a significant more marked and more sustained improvement in anxiety scores under LCIG.","[""Parkinson's disease"", 'thirteen PD patients chronically treated with LCIG and without history of non-motor swings', ""Parkinson's disease (PD""]","['levodopa/carbidopa intestinal gel (LCIG', 'encapsulated oral medication (LC-IR or placebo', 'LCIG', 'intermittent oral immediate-release carbidopa/levodopa\xa0(LC-IR) and LCIG', 'LCIG infusion plus three oral doses of placebo, or placebo infusion plus three oral doses of LC-IR', 'Oral vs. Intrajejunal Levodopa']","['temporal profile of motor status, anxiety, mood and cognition', 'plasmatic levels of levodopa, motor status (UPDRS-III), mood, anxiety, and frontal functions at baseline (0-h) and hourly after each oral challenge', 'acute affective and cognitive fluctuations', 'mood and verbal fluency', 'anxiety scores', 'Subclinical affective and cognitive fluctuations', 'fluctuations of levodopa plasma levels']","[{'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0023570', 'cui_str': 'Levodopa'}, {'cui': 'C0006982', 'cui_str': 'Carbidopa'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0262926', 'cui_str': 'History of'}]","[{'cui': 'C0023570', 'cui_str': 'Levodopa'}, {'cui': 'C0006982', 'cui_str': 'Carbidopa'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0205223', 'cui_str': 'Encapsulated'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0353697', 'cui_str': 'Carbidopa- and levodopa-containing product'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0442043', 'cui_str': 'Temporal'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0023570', 'cui_str': 'Levodopa'}, {'cui': 'C3639721', 'cui_str': 'UPDRS Panel'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0205123', 'cui_str': 'Coronal'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0558292', 'cui_str': 'Hourly'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0231239', 'cui_str': 'Fluctuation'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205211', 'cui_str': 'Subclinical'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}]",,0.283193,"However, point-to-point parametric and nonparametric tests showed a significant more marked and more sustained improvement in anxiety scores under LCIG.","[{'ForeName': 'Jaime', 'Initials': 'J', 'LastName': 'Kulisevsky', 'Affiliation': 'Movement Disorders Unit, Neurology Department, Hospital de la Santa Creu i Sant Pau, Mas Casanovas 90, 08041, Barcelona, Spain. jkulisevsky@santpau.cat.'}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Bejr-Kasem', 'Affiliation': 'Movement Disorders Unit, Neurology Department, Hospital de la Santa Creu i Sant Pau, Mas Casanovas 90, 08041, Barcelona, Spain.'}, {'ForeName': 'Saul', 'Initials': 'S', 'LastName': 'Martinez-Horta', 'Affiliation': 'Movement Disorders Unit, Neurology Department, Hospital de la Santa Creu i Sant Pau, Mas Casanovas 90, 08041, Barcelona, Spain.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Horta-Barba', 'Affiliation': 'Movement Disorders Unit, Neurology Department, Hospital de la Santa Creu i Sant Pau, Mas Casanovas 90, 08041, Barcelona, Spain.'}, {'ForeName': 'Berta', 'Initials': 'B', 'LastName': 'Pascual-Sedano', 'Affiliation': 'Movement Disorders Unit, Neurology Department, Hospital de la Santa Creu i Sant Pau, Mas Casanovas 90, 08041, Barcelona, Spain.'}, {'ForeName': 'Antonia', 'Initials': 'A', 'LastName': 'Campolongo', 'Affiliation': 'Movement Disorders Unit, Neurology Department, Hospital de la Santa Creu i Sant Pau, Mas Casanovas 90, 08041, Barcelona, Spain.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Marín-Lahoz', 'Affiliation': 'Movement Disorders Unit, Neurology Department, Hospital de la Santa Creu i Sant Pau, Mas Casanovas 90, 08041, Barcelona, Spain.'}, {'ForeName': 'Ignacio', 'Initials': 'I', 'LastName': 'Aracil-Bolaños', 'Affiliation': 'Movement Disorders Unit, Neurology Department, Hospital de la Santa Creu i Sant Pau, Mas Casanovas 90, 08041, Barcelona, Spain.'}, {'ForeName': 'Jesús', 'Initials': 'J', 'LastName': 'Pérez-Pérez', 'Affiliation': 'Movement Disorders Unit, Neurology Department, Hospital de la Santa Creu i Sant Pau, Mas Casanovas 90, 08041, Barcelona, Spain.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Izquierdo-Barrionuevo', 'Affiliation': 'Movement Disorders Unit, Neurology Department, Hospital de la Santa Creu i Sant Pau, Mas Casanovas 90, 08041, Barcelona, Spain.'}, {'ForeName': 'Oriol', 'Initials': 'O', 'LastName': 'de Fàbregues', 'Affiliation': ""Movement Disorders Unit, Neurology Department, Vall d'Hebron University Hospital, Neurodegenerative Diseases Research Group-Vall d'Hebron Research Institute, UAB, Barcelona, Spain.""}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Puente', 'Affiliation': ""Neurology Department, Institut Municipal d'Investigacio Medica, UAB, Hospital del Mar, Barcelona, Spain.""}, {'ForeName': 'Ane', 'Initials': 'A', 'LastName': 'Crespo-Cuevas', 'Affiliation': 'Department of Neurosciences, Hospital Universitari Germans Trias i Pujol, UAB, Badalona, Barcelona, Spain.'}, {'ForeName': 'Matilde', 'Initials': 'M', 'LastName': 'Calopa', 'Affiliation': 'Neurology Service, Hospital Universitari de Bellvitge, Barcelona, Spain.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Pagonabarraga', 'Affiliation': 'Movement Disorders Unit, Neurology Department, Hospital de la Santa Creu i Sant Pau, Mas Casanovas 90, 08041, Barcelona, Spain.'}]",Journal of neurology,['10.1007/s00415-020-10018-y'] 2460,32599215,Who enrolls in an online cancer survivorship program? Reach of the INSPIRE randomized controlled trial for hematopoietic cell transplantation survivors.,"BACKGROUND The internet can be a valuable tool in delivering survivorship care to hematopoietic cell transplantation (HCT) cancer survivors. We describe the reach of INSPIRE, an internet and social media-based randomized controlled trial, to address healthcare and psychosocial needs of HCT survivors. MATERIALS AND METHODS All survivors 2-10 years after HCT for hematologic malignancy or myelodysplasia from six transplant centers in the US were approached by mail and follow-up calls. Eligible participants had access to the internet, an email address, and did not have active disease in the past two years. We used logistic regression to determine characteristics of eligible survivors who were more or less likely to enroll. RESULTS Of 2578 eligible HCT survivors, 1065 (41%) enrolled in the study. Mean age of enrollees was 56.3 (SD=12.6; age range 19 to 89 years), 52% were male, and 94% were White. Survivors less likely to enroll included those who were male, age younger than 40, and who received an autologous transplant (all P<.001). Compared with survivors of white race, African Americans were less likely to enroll (P<.001) while Native Americans/Alaska Natives were more likely to join the study (P=.03). CONCLUSIONS Reach of the INSPIRE program was broad, including to survivors who traditionally have less access to resources such as Native Americans/Alaskan Natives and rural residents. Strategies are still needed to improve the enrollment of online studies of survivorship resources for males, young adults, African American and autologous HCT survivors, since their use may improve outcomes.",2020,"Compared with survivors of white race, African Americans were less likely to enroll (P<.001) while Native Americans/Alaska Natives were more likely to join the study (P=.03). ","['eligible survivors who were more or less likely to enroll', 'Survivors less likely to enroll included those who were male, age younger than 40, and who received an autologous transplant (all P<.001', 'hematopoietic cell transplantation survivors', 'Native Americans/Alaskan Natives and rural residents', 'hematopoietic cell transplantation (HCT) cancer survivors', 'Eligible participants had access to the internet, an email address, and did not have active disease in the past two years', '2578 eligible HCT survivors, 1065 (41%) enrolled in the study', 'Mean age of enrollees was 56.3 (SD=12.6; age range 19 to 89 years), 52% were male, and 94% were White']",['HCT'],[],"[{'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0040736', 'cui_str': 'Autogenous transplantation'}, {'cui': 'C0472699', 'cui_str': 'Hemopoietic stem cell transplant'}, {'cui': 'C0282204', 'cui_str': 'Native Americans'}, {'cui': 'C0682125', 'cui_str': 'Native Alaskians'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0013849', 'cui_str': 'Email'}, {'cui': 'C0376649', 'cui_str': 'Addresses'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}]","[{'cui': 'C0472699', 'cui_str': 'Hemopoietic stem cell transplant'}]",[],2578.0,0.117693,"Compared with survivors of white race, African Americans were less likely to enroll (P<.001) while Native Americans/Alaska Natives were more likely to join the study (P=.03). ","[{'ForeName': 'Jean C', 'Initials': 'JC', 'LastName': 'Yi', 'Affiliation': 'Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, WA. Electronic address: jyi@fredhutch.org.'}, {'ForeName': 'Brie', 'Initials': 'B', 'LastName': 'Sullivan', 'Affiliation': 'Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, WA.'}, {'ForeName': 'Wendy M', 'Initials': 'WM', 'LastName': 'Leisenring', 'Affiliation': 'Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, WA.'}, {'ForeName': 'Navneet S', 'Initials': 'NS', 'LastName': 'Majhail', 'Affiliation': 'Cleveland Clinic, Cleveland, OH.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Jim', 'Affiliation': 'Moffitt Cancer Center, Tampa, FL.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Loren', 'Affiliation': 'University of Pennsylvania, Philadelphia, PA.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Uberti', 'Affiliation': 'Barbara Ann Karmanos Cancer Institute, Detroit, MI.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Whalen', 'Affiliation': 'University of Nebraska, Omaha, NB.'}, {'ForeName': 'Mary Ed', 'Initials': 'ME', 'LastName': 'Flowers', 'Affiliation': 'Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, WA; University of Washington School of Medicine, Seattle, WA.'}, {'ForeName': 'Stephanie J', 'Initials': 'SJ', 'LastName': 'Lee', 'Affiliation': 'Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, WA; University of Washington School of Medicine, Seattle, WA.'}, {'ForeName': 'Katie Maynard', 'Initials': 'KM', 'LastName': 'Msw', 'Affiliation': 'Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, WA.'}, {'ForeName': 'Karen L', 'Initials': 'KL', 'LastName': 'Syrjala', 'Affiliation': 'Clinical Research Division, Fred Hutchinson Cancer Research Center, Seattle, WA; University of Washington School of Medicine, Seattle, WA.'}]",Biology of blood and marrow transplantation : journal of the American Society for Blood and Marrow Transplantation,['10.1016/j.bbmt.2020.06.017'] 2461,32599257,"A multicenter trial of a shared DECision Support Intervention for Patients offered implantable Cardioverter-DEfibrillators: DECIDE-ICD rationale, design, Medicare changes, and pilot data.","Shared decision making (SDM) facilitates delivery of medical therapies that are in alignment with patients' goals and values. Medicare national coverage decision for several interventions now includes SDM mandates, but few have been evaluated in nationwide studies. Based upon a detailed needs assessment with diverse stakeholders, we developed pamphlet and video patient decision aids (PtDAs) for implantable cardioverter/defibrillator (ICD) implantation, ICD replacement, and cardiac resynchronization therapy with defibrillation to help patients contemplate, forecast, and deliberate their options. These PtDAs are the foundation of the Multicenter Trial of a Shared Decision Support Intervention for Patients Offered Implantable Cardioverter-Defibrillators (DECIDE-ICD), a multicenter, randomized trial sponsored by the National Heart, Lung, and Blood Institute aimed at understanding the effectiveness and implementation of an SDM support intervention for patients considering ICDs. Finalization of a Medicare coverage decision mandating the inclusion of SDM for new ICD implantation occurred shortly after trial initiation, raising novel practical and statistical considerations for evaluating study end points. METHODS/DESIGN: A stepped-wedge randomized controlled trial was designed, guided by the RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) planning and evaluation framework using an effectiveness-implementation hybrid type II design. Six electrophysiology programs from across the United States will participate. The primary effectiveness outcome is decision quality (defined by knowledge and values-treatment concordance). Patients with heart failure who are clinically eligible for an ICD are eligible for the study. Target enrollment is 900 participants. DISCUSSION: Study findings will provide a foundation for implementing decision support interventions, including PtDAs, with patients who have chronic progressive illness and are facing decisions involving invasive, preference-sensitive therapy options.",2020,"Finalization of a Medicare coverage decision mandating the inclusion of SDM for new ICD implantation occurred shortly after trial initiation, raising novel practical and statistical considerations for evaluating study end points.","['Patients with heart failure who are clinically eligible for an ICD are eligible for the study', 'Patients offered implantable Cardioverter-DEfibrillators', 'patients who have chronic progressive illness', '900 participants']","['implantable cardioverter/defibrillator (ICD) implantation, ICD replacement, and cardiac resynchronization therapy with defibrillation', 'shared DECision Support Intervention']",['decision quality (defined by knowledge and values-treatment concordance'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0162589', 'cui_str': 'Implantable defibrillator'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C4517900', 'cui_str': '900'}]","[{'cui': 'C0162589', 'cui_str': 'Implantable defibrillator'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C1167956', 'cui_str': 'Cardiac resynchronisation therapy'}, {'cui': 'C0013778', 'cui_str': 'Cardioversion'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",,0.0983498,"Finalization of a Medicare coverage decision mandating the inclusion of SDM for new ICD implantation occurred shortly after trial initiation, raising novel practical and statistical considerations for evaluating study end points.","[{'ForeName': 'Bryan C', 'Initials': 'BC', 'LastName': 'Wallace', 'Affiliation': 'Adult and Child Consortium for Outcomes Research and Delivery Science, Aurora, CO.'}, {'ForeName': 'Larry A', 'Initials': 'LA', 'LastName': 'Allen', 'Affiliation': 'Adult and Child Consortium for Outcomes Research and Delivery Science, Aurora, CO; Advanced Heart Failure and Transplantation, Division of Cardiology, and Adult and Child Center for Health Outcomes Research and Delivery Science, School of Medicine, University of Colorado, Aurora, CO; Colorado Cardiovascular Outcomes Research Consortium, Denver, CO; Division of Cardiology, University of Colorado School of Medicine, Aurora, CO.'}, {'ForeName': 'Christopher E', 'Initials': 'CE', 'LastName': 'Knoepke', 'Affiliation': 'Adult and Child Consortium for Outcomes Research and Delivery Science, Aurora, CO; Division of Cardiology, University of Colorado School of Medicine, Aurora, CO.'}, {'ForeName': 'Russell E', 'Initials': 'RE', 'LastName': 'Glasgow', 'Affiliation': 'Adult and Child Consortium for Outcomes Research and Delivery Science, Aurora, CO; VA Eastern Colorado Geriatric Research Education and Clinical Center, Denver, CO.'}, {'ForeName': 'Carmen L', 'Initials': 'CL', 'LastName': 'Lewis', 'Affiliation': 'Adult and Child Consortium for Outcomes Research and Delivery Science, Aurora, CO.'}, {'ForeName': 'Diane L', 'Initials': 'DL', 'LastName': 'Fairclough', 'Affiliation': 'Adult and Child Consortium for Outcomes Research and Delivery Science, Aurora, CO; Department of Biostatistics and Informatics, University of Colorado School of Public Health, Aurora, CO.'}, {'ForeName': 'Laura J', 'Initials': 'LJ', 'LastName': 'Helmkamp', 'Affiliation': 'Adult and Child Consortium for Outcomes Research and Delivery Science, Aurora, CO; Department of Biostatistics and Informatics, University of Colorado School of Public Health, Aurora, CO.'}, {'ForeName': 'Monica D', 'Initials': 'MD', 'LastName': 'Fitzgerald', 'Affiliation': 'Adult and Child Consortium for Outcomes Research and Delivery Science, Aurora, CO.'}, {'ForeName': 'Wendy S', 'Initials': 'WS', 'LastName': 'Tzou', 'Affiliation': 'Advanced Heart Failure and Transplantation, Division of Cardiology, and Adult and Child Center for Health Outcomes Research and Delivery Science, School of Medicine, University of Colorado, Aurora, CO; VA Eastern Colorado Geriatric Research Education and Clinical Center, Denver, CO; Denver Health Medical Center, Denver, CO.'}, {'ForeName': 'Daniel B', 'Initials': 'DB', 'LastName': 'Kramer', 'Affiliation': 'Richard A. and Susan F. Smith Center for Outcomes Research in Cardiology, Beth Israel Deaconess Medical Center, Boston, MA.'}, {'ForeName': 'Paul D', 'Initials': 'PD', 'LastName': 'Varosy', 'Affiliation': 'Colorado Cardiovascular Outcomes Research Consortium, Denver, CO; Division of Cardiology, University of Colorado School of Medicine, Aurora, CO; Cardiology Section, VA Eastern Colorado Health Care System, Aurora, CO.'}, {'ForeName': 'Sanjaya K', 'Initials': 'SK', 'LastName': 'Gupta', 'Affiliation': ""Saint Luke's Mid-America Heart Institute, Kansas City, MO.""}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Mandrola', 'Affiliation': 'Baptist Health Louisville, Louisville, KY.'}, {'ForeName': 'Scott C', 'Initials': 'SC', 'LastName': 'Brancato', 'Affiliation': 'Providence Heart Institute, Portland, OR.'}, {'ForeName': 'Pamela N', 'Initials': 'PN', 'LastName': 'Peterson', 'Affiliation': 'Colorado Cardiovascular Outcomes Research Consortium, Denver, CO; Division of Cardiology, University of Colorado School of Medicine, Aurora, CO; Denver Health Medical Center, Denver, CO.'}, {'ForeName': 'Daniel D', 'Initials': 'DD', 'LastName': 'Matlock', 'Affiliation': 'Adult and Child Consortium for Outcomes Research and Delivery Science, Aurora, CO; VA Eastern Colorado Geriatric Research Education and Clinical Center, Denver, CO; Division of Geriatric Medicine, Department of Medicine, University of Colorado School of Medicine, Aurora, CO.'}]",American heart journal,['10.1016/j.ahj.2020.04.010'] 2462,32599274,Family nurture intervention alters relationships between preterm infant EEG delta brush characteristics and term age EEG power.,"OBJECTIVE Family Nurture Intervention (FNI) facilitates mother/infant emotional connection, improves neurodevelopmental outcomes and increases electroencephalogram (EEG) power at term age. Here we explored whether delta brushes (DB), early EEG bursts that shape brain development, are altered by FNI and mediate later effects of FNI on EEG. METHODS We assessed DB characteristics in EEG data from a randomized controlled trial comparing infants with standard care (SC, n = 31) versus SC + FNI (n = 33) at ~35 and ~40 weeks GA. RESULTS Compared to SC infants, FNI infant DB amplitude increased more from ~35 to ~40 weeks, and FNI infants had longer duration DBs. DB parameters (rate, amplitude, brush frequency) at ~35 weeks were correlated with power at ~40 weeks, but only in SC infants. FNI effects on DB parameters do not mediate FNI effects on EEG power or coherence at term. CONCLUSIONS DBs are related to subsequent brain activity and FNI alters DB parameters. However, FNI's effects on electrocortical activity at term age are not dependent on its earlier effects on DBs. SIGNIFICANCE While early DBs can have important effects on later brain activity in preterm infants, facilitating emotional connection with FNI may allow brain maturation to be less dependent on early bursts.",2020,"FNI effects on DB parameters do not mediate FNI effects on EEG power or coherence at term. ","['infants with standard care (SC, n\xa0=\xa031) versus', 'preterm infants']","['Family nurture intervention', 'SC\xa0+\xa0FNI']","['neurodevelopmental outcomes and increases electroencephalogram (EEG', 'FNI infant DB amplitude', 'DB parameters (rate, amplitude, brush frequency', 'longer duration DBs', 'electrocortical activity']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}]","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0439097', 'cui_str': 'Delta'}, {'cui': 'C0040461', 'cui_str': 'Brushing of teeth'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0439591', 'cui_str': 'Long duration'}, {'cui': 'C0394162', 'cui_str': 'Deep brain stimulation'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",,0.0522774,"FNI effects on DB parameters do not mediate FNI effects on EEG power or coherence at term. ","[{'ForeName': 'Martha G', 'Initials': 'MG', 'LastName': 'Welch', 'Affiliation': 'Department of Pediatrics, Columbia University Medical Center, 630 W. 168(th) St, New York, NY 10032, USA; Department of Psychiatry, Columbia University Medical Center, New York, NY, USA. Electronic address: mgw13@columbia.edu.'}, {'ForeName': 'Philip G', 'Initials': 'PG', 'LastName': 'Grieve', 'Affiliation': 'Department of Pediatrics, Columbia University Medical Center, 630 W. 168(th) St, New York, NY 10032, USA. Electronic address: pgg3@columbia.edu.'}, {'ForeName': 'Joseph L', 'Initials': 'JL', 'LastName': 'Barone', 'Affiliation': 'Department of Pediatrics, Columbia University Medical Center, 630 W. 168(th) St, New York, NY 10032, USA. Electronic address: JB3908@columbia.edu.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Ludwig', 'Affiliation': 'Department of Pediatrics, Columbia University Medical Center, 630 W. 168(th) St, New York, NY 10032, USA. Electronic address: rjl2128@columbia.edu.'}, {'ForeName': 'Raymond I', 'Initials': 'RI', 'LastName': 'Stark', 'Affiliation': 'Department of Pediatrics, Columbia University Medical Center, 630 W. 168(th) St, New York, NY 10032, USA. Electronic address: ris2@columbia.edu.'}, {'ForeName': 'Joseph R', 'Initials': 'JR', 'LastName': 'Isler', 'Affiliation': 'Department of Pediatrics, Columbia University Medical Center, 630 W. 168(th) St, New York, NY 10032, USA. Electronic address: jri2101@columbia.edu.'}, {'ForeName': 'Michael M', 'Initials': 'MM', 'LastName': 'Myers', 'Affiliation': 'Department of Pediatrics, Columbia University Medical Center, 630 W. 168(th) St, New York, NY 10032, USA; Department of Psychiatry, Columbia University Medical Center, New York, NY, USA. Electronic address: mmm3@columbia.edu.'}]",Clinical neurophysiology : official journal of the International Federation of Clinical Neurophysiology,['10.1016/j.clinph.2020.05.020'] 2463,32599445,A comparison of the three year course between chronic depression and depression with multiple vs. few prior episodes.,"This study tested the hypothesis that chronic depression (CD) is more similar to depression with multiple prior episodes (ME) than to depression with few prior episodes (FE). Data from participants (n = 1013) with mild to moderate depressive symptoms (Patient Health Questionnaire [PHQ-9] score 5 - 14) who took part in a randomized control trial of an internet intervention for depression (EVIDENT trial) were re-analyzed. The MINI-interview was conducted to diagnose CD (n = 376). If CD was not diagnosed, the self-reported number of depressive episodes was used to categorize participants as having episodic depression with up to five (FE, n = 422) or more than five (ME, n = 215) prior episodes. Over a three-year period, participants were assessed repeatedly regarding the course of depression (PHQ-9, QIDS), quality of life (SF-12) and therapeutic progress (FEP-2). At baseline, most scores were different between CD and FE but comparable between CD and ME. Time to remission did not differ between CD and ME but was longer in CD compared to FE. Results suggest that ME closely resembles CD and that CD differs from FE.",2020,Time to remission did not differ between CD and ME but was longer in CD compared to FE.,['Data from participants (n\xa0=\xa01013) with mild to moderate depressive symptoms (Patient Health Questionnaire [PHQ-9] score 5 - 14) who took part in a randomized control trial of an'],['internet intervention'],"['Time to remission', 'course of depression (PHQ-9, QIDS), quality of life (SF-12) and therapeutic progress (FEP-2']","[{'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C1879301', 'cui_str': 'PHQ Patient Health Questionnaire'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0282440', 'cui_str': 'Randomized Controlled Trials as Topic'}]","[{'cui': 'C3898714', 'cui_str': 'Internet Intervention'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0585291', 'cui_str': 'Four times daily'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0032611', 'cui_str': 'Polytetrafluoroethylene'}]",1013.0,0.0348744,Time to remission did not differ between CD and ME but was longer in CD compared to FE.,"[{'ForeName': 'Elke', 'Initials': 'E', 'LastName': 'Humer', 'Affiliation': 'Department for Psychotherapy and Biopsychosocial Health, Danube University Krems, Krems, Austria.'}, {'ForeName': 'Krisztina', 'Initials': 'K', 'LastName': 'Kocsis-Bogar', 'Affiliation': 'Department for Psychotherapy and Biopsychosocial Health, Danube University Krems, Krems, Austria.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Berger', 'Affiliation': 'Department of Clinical Psychology and Psychotherapy, University of Bern, Bern, Switzerland.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Schröder', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Medical-Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Späth', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Lübeck University, 23538 Lübeck, Germany.'}, {'ForeName': 'Björn', 'Initials': 'B', 'LastName': 'Meyer', 'Affiliation': 'Research Department, Gaia AG, Hamburg, Germany; Department of Psychology, City, University of London, United Kingdom.'}, {'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Moritz', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Medical-Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Lutz', 'Affiliation': 'Department of Psychology, University of Trier, Trier, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Probst', 'Affiliation': 'Department for Psychotherapy and Biopsychosocial Health, Danube University Krems, Krems, Austria.'}, {'ForeName': 'Jan Philipp', 'Initials': 'JP', 'LastName': 'Klein', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Lübeck University, 23538 Lübeck, Germany. Electronic address: philipp.klein@uksh.de.'}]",Psychiatry research,['10.1016/j.psychres.2020.113235'] 2464,32599652,"Single Dose Pharmacokinetics and Pharmacodynamics of Transthyretin Targeting GalNAc-siRNA Conjugate, Vutrisiran, in Healthy Subjects.","Vutrisiran (ALN-TTRsc02) is a liver-directed, investigational, small interfering ribonucleic acid drug for the treatment of transthyretin (TTR)-mediated amyloidosis. This Phase 1, randomized, single-blind, placebo-controlled, single ascending dose study evaluated the pharmacodynamics, pharmacokinetics, and safety profile of subcutaneously-administered vutrisiran (5-300 mg) in healthy subjects (n = 80). Vutrisiran treatment achieved potent and sustained TTR reduction in a dose-dependent manner, with mean maximum TTR reduction of 57-97%, maintained for ≥90 days post-dose. Vutrisiran was rapidly absorbed (peak plasma concentration 3-5 h post-dose), had a short plasma half-life (4.2-7.5 h), and plasma concentrations increased in a dose-proportional manner. Pharmacodynamic and pharmacokinetic results were similar in Japanese and non-Japanese subjects. Vutrisiran had an acceptable safety profile; the most common treatment-related adverse event was mild, transient injection site reactions in four (6.7%) vutrisiran-treated subjects. The favorable pharmacokinetic, pharmacodynamic, and safety results observed here support vutrisiran's continued clinical development.",2020,"Vutrisiran had an acceptable safety profile; the most common treatment-related adverse event was mild, transient injection site reactions in four (6.7%) vutrisiran-treated subjects.","['healthy subjects (n = 80', 'Japanese and non-Japanese subjects', 'Healthy Subjects']","['subcutaneously-administered vutrisiran', 'placebo']","['mean maximum TTR reduction', 'potent and sustained TTR reduction', 'plasma concentrations', 'pharmacodynamics, pharmacokinetics, and safety profile']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}]","[{'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0032923', 'cui_str': 'Prealbumin'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.034292,"Vutrisiran had an acceptable safety profile; the most common treatment-related adverse event was mild, transient injection site reactions in four (6.7%) vutrisiran-treated subjects.","[{'ForeName': 'Bahru A', 'Initials': 'BA', 'LastName': 'Habtemariam', 'Affiliation': 'Alnylam Pharmaceuticals, Cambridge, MA, USA.'}, {'ForeName': 'Verena', 'Initials': 'V', 'LastName': 'Karsten', 'Affiliation': 'Alnylam Pharmaceuticals, Cambridge, MA, USA.'}, {'ForeName': 'Husain', 'Initials': 'H', 'LastName': 'Attarwala', 'Affiliation': 'Currently at Moderna Therapeutics, Cambridge, MA, USA.'}, {'ForeName': 'Varun', 'Initials': 'V', 'LastName': 'Goel', 'Affiliation': 'Alnylam Pharmaceuticals, Cambridge, MA, USA.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Melch', 'Affiliation': 'Alnylam Pharmaceuticals, Cambridge, MA, USA.'}, {'ForeName': 'Valerie A', 'Initials': 'VA', 'LastName': 'Clausen', 'Affiliation': 'Alnylam Pharmaceuticals, Cambridge, MA, USA.'}, {'ForeName': 'Pushkal', 'Initials': 'P', 'LastName': 'Garg', 'Affiliation': 'Alnylam Pharmaceuticals, Cambridge, MA, USA.'}, {'ForeName': 'Akshay K', 'Initials': 'AK', 'LastName': 'Vaishnaw', 'Affiliation': 'Alnylam Pharmaceuticals, Cambridge, MA, USA.'}, {'ForeName': 'Marianne T', 'Initials': 'MT', 'LastName': 'Sweetser', 'Affiliation': 'Alnylam Pharmaceuticals, Cambridge, MA, USA.'}, {'ForeName': 'Gabriel J', 'Initials': 'GJ', 'LastName': 'Robbie', 'Affiliation': 'Alnylam Pharmaceuticals, Cambridge, MA, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Vest', 'Affiliation': 'Alnylam Pharmaceuticals, Cambridge, MA, USA.'}]",Clinical pharmacology and therapeutics,['10.1002/cpt.1974'] 2465,32599670,Muscle contractile properties of cancer patients receiving chemotherapy: assessment of feasibility and exercise effects.,"BACKGROUND This pilot trial explores the feasibility of measuring muscle contractile properties in patients with cancer, effects of exercise during chemotherapy on muscle contractile properties and the association between changes in contractile muscle properties and perceived fatigue. METHOD Patients who received (neo)adjuvant chemotherapy for breast or colon cancer were randomized to a 9-12 week exercise intervention or a waitlist-control group. At baseline and follow-up, we measured knee extensor strength using maximal voluntary contraction (MVC), contractile muscle properties of the quadriceps muscle using electrical stimulation, and perceived fatigue using the Multidimensional Fatigue Inventory. Feasibility was assessed by the proportion of patients who successfully completed measurements of contractile muscle properties. Exercise effects on muscle contractile properties were explored using linear regression analyses. Between-group differences >10% were considered potentially relevant. Pearson correlation (r p ) of changes in contractile muscle properties and changes in perceived fatigue was calculated. RESULTS 22 of 30 patients completed baseline and follow-up assessments. Measurements of contractile properties were feasible except for muscle fatigability. We found a potentially relevant between-group difference in the rate of force development favouring the intervention group (1192 N/s, 95%CI=-335;2739). Change in rate of force development was negatively correlated with change in perceived general (r p =-0.54, p=0.04) and physical (r p =-0.59, p=0.02) fatigue). CONCLUSION Chemotherapy induces a decrease in the rate of force development, which may reflect a larger loss in type II muscle fibers. This may be attenuated with (resistance) exercise. The increase in the rate of force development was related to a decrease in perceived fatigue.",2020,"Change in rate of force development was negatively correlated with change in perceived general (r p =-0.54, p=0.04) and physical (r p =-0.59, p=0.02) fatigue). ","['cancer patients receiving', 'Patients who received (neo)adjuvant chemotherapy for breast or colon cancer', 'patients with cancer']","['chemotherapy', 'Chemotherapy', 'exercise intervention or a waitlist-control group']","['perceived fatigue', 'rate of force development', 'knee extensor strength using maximal voluntary contraction (MVC), contractile muscle properties of the quadriceps muscle using electrical stimulation, and perceived fatigue using the Multidimensional Fatigue Inventory', 'muscle contractile properties']","[{'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0006141', 'cui_str': 'Breast structure'}, {'cui': 'C0007102', 'cui_str': 'Malignant tumor of colon'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}, {'cui': 'C0026820', 'cui_str': 'Muscle contraction'}, {'cui': 'C0231493', 'cui_str': 'Muscle property'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0871161', 'cui_str': 'Property'}]",,0.0475002,"Change in rate of force development was negatively correlated with change in perceived general (r p =-0.54, p=0.04) and physical (r p =-0.59, p=0.02) fatigue). ","[{'ForeName': 'L M', 'Initials': 'LM', 'LastName': 'Buffart', 'Affiliation': 'Radboudumc, Department of Physiology, Radboud Institute for Health Sciences, Nijmegen, The Netherlands.'}, {'ForeName': 'M G', 'Initials': 'MG', 'LastName': 'Sweegers', 'Affiliation': 'Amsterdam UMC, Vrije Universiteit Amsterdam, Department of Epidemiology and Biostatistics, Amsterdam Public Health research institute, The Netherlands.'}, {'ForeName': 'C J', 'Initials': 'CJ', 'LastName': 'de Ruiter', 'Affiliation': 'Faculty of Behavioural and Movement Sciences, Amsterdam Movement Sciences, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'I R', 'Initials': 'IR', 'LastName': 'Konings', 'Affiliation': 'Amsterdam UMC, Vrije Universiteit Amsterdam, Department of Medical Oncology, Cancer Center Amsterdam, The Netherlands.'}, {'ForeName': 'H M W', 'Initials': 'HMW', 'LastName': 'Verheul', 'Affiliation': 'Radboudumc, Department of Medical Oncology, Nijmegen, The Netherlands.'}, {'ForeName': 'A A', 'Initials': 'AA', 'LastName': 'van Zweeden', 'Affiliation': 'Amsterdam UMC, Vrije Universiteit Amsterdam, Department of Medical Oncology, Cancer Center Amsterdam, The Netherlands.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Grootscholten', 'Affiliation': 'Netherlands Cancer Institute, Department of Gastrointestinal Oncology, Amsterdam, The Netherlands.'}, {'ForeName': 'M J', 'Initials': 'MJ', 'LastName': 'Chin A Paw', 'Affiliation': 'Amsterdam UMC, Vrije Universiteit Amsterdam, Department of Public and Occupational health and Amsterdam Public Health research institute, Amsterdam, The Netherlands.'}, {'ForeName': 'T M', 'Initials': 'TM', 'LastName': 'Altenburg', 'Affiliation': 'Amsterdam UMC, Vrije Universiteit Amsterdam, Department of Public and Occupational health and Amsterdam Public Health research institute, Amsterdam, The Netherlands.'}]",Scandinavian journal of medicine & science in sports,['10.1111/sms.13758'] 2466,32599697,Osteopathic Manipulative Treatment in Neonatal Intensive Care Units.,"The aim of this study was to assess the impact of osteopathic manipulative treatment (OMT) on newborn babies admitted at a neonatal intensive care unit (NICU). This was an observational, longitudinal, retrospective study. All consecutive admitted babies were analyzed by treatment (OMT vs. usual care). Treatment group was randomly assigned. Between-group differences in weekly weight change and length of stay (LOS) were evaluated in the overall and preterm populations. Among 1249 babies (48.9% preterm) recorded, 652 received usual care and 597 received OMT. Weight increase was more marked in the OMT group than in the control group (weekly change: +83 g vs. +35 g; p < 0.001). Similar trends were found in the subgroup of preterm babies. A shorter LOS was found in the OMT group vs. the usual care group both in overall population (average mean difference: -7.9 days, p = 0.15) and in preterm babies (-12.3 days; p = 0.04). In severe preterm babies, mean LOS was more than halved as compared to the control group. OMT was associated with a more marked weekly weight increase and, especially in preterm babies, to a relevant LOS reduction: OMT may represent an efficient support to usual care in newborn babies admitted at a NICU.",2020,"A shorter LOS was found in the OMT group vs. the usual care group both in overall population (average mean difference: -7.9 days, p = 0.15) and in preterm babies (-12.3 days; p = 0.04).","['Neonatal Intensive Care Units', '1249 babies (48.9% preterm) recorded, 652 received usual care and 597 received', 'newborn babies admitted at a NICU', 'newborn babies admitted at a neonatal intensive care unit (NICU']","['osteopathic manipulative treatment (OMT', 'OMT', 'Osteopathic Manipulative Treatment']","['weekly weight change and length of stay (LOS', 'mean LOS', 'Weight increase', 'LOS']","[{'cui': 'C0021709', 'cui_str': 'Neonatal intensive care unit'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}]","[{'cui': 'C0949744', 'cui_str': 'Osteopathic manipulation'}]","[{'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0005911', 'cui_str': 'Weight change'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}]",,0.0615084,"A shorter LOS was found in the OMT group vs. the usual care group both in overall population (average mean difference: -7.9 days, p = 0.15) and in preterm babies (-12.3 days; p = 0.04).","[{'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Cicchitti', 'Affiliation': 'A.I.O.T-Traditional Osteopathy Italian Academy, 65125 Pescara, Italy.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Di Lelio', 'Affiliation': 'CORESEARCH-Center for Outcomes Research and Clinical Epidemiology, 65124 Pescara, Italy.'}, {'ForeName': 'Gina', 'Initials': 'G', 'LastName': 'Barlafante', 'Affiliation': 'A.I.O.T-Traditional Osteopathy Italian Academy, 65125 Pescara, Italy.'}, {'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'Cozzolino', 'Affiliation': 'A.I.O.T-Traditional Osteopathy Italian Academy, 65125 Pescara, Italy.'}, {'ForeName': 'Susanna', 'Initials': 'S', 'LastName': 'Di Valerio', 'Affiliation': 'Neonatal Intensive Care Unit, Santo Spirito Hospital, 65126 Pescara, Italy.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Fusilli', 'Affiliation': 'Neonatal Intensive Care Unit, Santo Spirito Hospital, 65126 Pescara, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Lucisano', 'Affiliation': 'CORESEARCH-Center for Outcomes Research and Clinical Epidemiology, 65124 Pescara, Italy.'}, {'ForeName': 'Cinzia', 'Initials': 'C', 'LastName': 'Renzetti', 'Affiliation': 'A.I.O.T-Traditional Osteopathy Italian Academy, 65125 Pescara, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Verzella', 'Affiliation': 'A.I.O.T-Traditional Osteopathy Italian Academy, 65125 Pescara, Italy.'}, {'ForeName': 'Maria Chiara', 'Initials': 'MC', 'LastName': 'Rossi', 'Affiliation': 'CORESEARCH-Center for Outcomes Research and Clinical Epidemiology, 65124 Pescara, Italy.'}]","Medical sciences (Basel, Switzerland)",['10.3390/medsci8020024'] 2467,32599716,Effects of Creatine Supplementation during Resistance Training Sessions in Physically Active Young Adults.,"The purpose was to examine the effects of creatine supplementation during resistance training sessions on skeletal muscle mass and exercise performance in physically active young adults. Twenty-two participants were randomized to supplement with creatine (CR: n = 13, 26 ± 4 yrs; 0.0055 g·kg -1 post training set) or placebo (PLA: n = 9, 26 ± 5 yrs; 0.0055 g·kg -1 post training set) during six weeks of resistance training (18 sets per training session; five days per week). Prior to and following training and supplementation, measurements were made for muscle thickness (elbow and knee flexors/extensors, ankle plantarflexors), power (vertical jump and medicine ball throw), strength (leg press and chest press one-repetition maximum (1-RM)) and muscular endurance (one set of repetitions to volitional fatigue using 50% baseline 1-RM for leg press and chest press). The creatine group experienced a significant increase ( p < 0.05) in leg press, chest press and total body strength and leg press endurance with no significant changes in the PLA group. Both groups improved total body endurance over time ( p < 0.05), with greater gains observed in the creatine group. In conclusion, creatine ingestion during resistance training sessions is a viable strategy for improving muscle strength and some indices of muscle endurance in physically active young adults.",2020,"The creatine group experienced a significant increase ( p < 0.05) in leg press, chest press and total body strength and leg press endurance with no significant changes in the PLA group.","['Physically Active Young Adults', 'physically active young adults']","['Creatine Supplementation', 'placebo (PLA: n = 9, 26 ± 5 yrs; 0.0055 g·kg -1 post training set) during six weeks of resistance training', 'resistance training sessions', 'supplement with creatine (CR', 'creatine supplementation']","['muscle thickness (elbow and knee flexors/extensors, ankle plantarflexors), power (vertical jump and medicine ball throw), strength (leg press and chest press one-repetition maximum (1-RM)) and muscular endurance (one set of repetitions to volitional fatigue', 'total body endurance', 'skeletal muscle mass and exercise performance', 'leg press, chest press and total body strength and leg press endurance']","[{'cui': 'C0556453', 'cui_str': 'Physically active'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}]","[{'cui': 'C0010286', 'cui_str': 'Creatine'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0456170', 'cui_str': 'Left atrial pressure'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}]","[{'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0013769', 'cui_str': 'Elbow region structure'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0039597', 'cui_str': 'Testis structure'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0442025', 'cui_str': 'Muscular'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",22.0,0.0489477,"The creatine group experienced a significant increase ( p < 0.05) in leg press, chest press and total body strength and leg press endurance with no significant changes in the PLA group.","[{'ForeName': 'Scotty', 'Initials': 'S', 'LastName': 'Mills', 'Affiliation': 'Faculty of Kinesiology and Health Studies, University of Regina, Regina, SK S4S0A2, Canada.'}, {'ForeName': 'Darren G', 'Initials': 'DG', 'LastName': 'Candow', 'Affiliation': 'Faculty of Kinesiology and Health Studies, University of Regina, Regina, SK S4S0A2, Canada.'}, {'ForeName': 'Scott C', 'Initials': 'SC', 'LastName': 'Forbes', 'Affiliation': 'Department of Physical Education, Faculty of Education, Brandon University, Brandon, MB R7A6A9, Canada.'}, {'ForeName': 'J Patrick', 'Initials': 'JP', 'LastName': 'Neary', 'Affiliation': 'Faculty of Kinesiology and Health Studies, University of Regina, Regina, SK S4S0A2, Canada.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Ormsbee', 'Affiliation': 'Institute of Sports Sciences & Medicine, Department of Nutrition, Food, & Exercise Sciences, Florida State University, Tallahassee, FL 32313, USA.'}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Antonio', 'Affiliation': 'Department of Health and Human Performance, Nova Southeastern University, Davie, FL 33314, USA.'}]",Nutrients,['10.3390/nu12061880'] 2468,32599738,Are Sugar-Reduced and Whole Grain Infant Cereals Sensorially Accepted at Weaning? A Randomized Controlled Cross-Over Trial.,"The way infants are fed during the complementary period can have a significant impact on infants' health and development. Infant cereals play an important role in complementary feeding in many countries. In spite of well documented benefits of a low sugar and high whole grain diet, commercial infant cereals are often refined and contain a high amount of sugars. The aim of the present study was to compare the sensory acceptability, gastrointestinal tolerance and bowel habits of two commercially available infant cereals in Spain with varying sugar and whole grain contents in infants at weaning. Forty-six healthy infants (mean age = 5.2 ± 0.4 months) received one of the two infant cereals containing either 0% whole grain flour and a high sugar content produced by starch hydrolysis (24 g/100 g) (Cereal A) or 50% whole grain flour and a medium-sugar content produced by hydrolysis (12 g/100 g) (Cereal B) in a randomized, triple blind, cross-over controlled trial. Both types of infant cereals were consumed for seven weeks. The cross-over was carried out after seven weeks. Sensory acceptability, anthropometry, gastrointestinal tolerance and adverse events were measured, and results evaluated using a linear regression model. No significant differences were observed between groups in any of the main variables analyzed. Importantly, the long-term health implications of our findings represent a wake-up call for the food industry to reduce or even eliminate simple sugars in infant cereals and for regulatory bodies and professional organizations to recommend whole grain infant cereals.",2020,No significant differences were observed between groups in any of the main variables analyzed.,"['Spain with varying sugar and whole grain contents in infants at weaning', 'Forty-six healthy infants (mean age = 5.2 ± 0.4 months']",['infant cereals containing either 0% whole grain flour and a high sugar content produced by starch hydrolysis (24 g/100 g) (Cereal A) or 50% whole grain flour and a medium-sugar content produced by hydrolysis'],"['Sensory acceptability, anthropometry, gastrointestinal tolerance and adverse events', 'sensory acceptability, gastrointestinal tolerance and bowel habits']","[{'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C4042940', 'cui_str': 'Whole Grains'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0043084', 'cui_str': 'Weaning'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517790', 'cui_str': '5.2'}, {'cui': 'C4517457', 'cui_str': '0.4'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0007757', 'cui_str': 'Cereal'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C4042940', 'cui_str': 'Whole Grains'}, {'cui': 'C0016260', 'cui_str': 'Flour'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0038179', 'cui_str': 'Starch'}, {'cui': 'C0020291', 'cui_str': 'Hydrolysis'}, {'cui': 'C0009458', 'cui_str': 'Communications Media'}]","[{'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0003188', 'cui_str': 'Anthropometry'}, {'cui': 'C0013220', 'cui_str': 'Drug tolerance'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}]",46.0,0.100743,No significant differences were observed between groups in any of the main variables analyzed.,"[{'ForeName': 'Luis Manuel', 'Initials': 'LM', 'LastName': 'Sanchez-Siles', 'Affiliation': 'Research and Nutrition Lab, Hero Group, 30820 Murcia, Spain.'}, {'ForeName': 'Maria Jose', 'Initials': 'MJ', 'LastName': 'Bernal', 'Affiliation': 'Research and Nutrition Lab, Hero Group, 30820 Murcia, Spain.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Gil', 'Affiliation': 'Pediatric Gastroenterology, Hepatology and Nutrition Unit, Hospital Clínico Universitario Virgen de la Arrixaca, 30120 Murcia, Spain.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Bodenstab', 'Affiliation': 'Institute for Research and Nutrition, Hero Group, 5600 Lenzburg, Switzerland.'}, {'ForeName': 'Juan Francisco', 'Initials': 'JF', 'LastName': 'Haro-Vicente', 'Affiliation': 'Research and Nutrition Lab, Hero Group, 30820 Murcia, Spain.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Klerks', 'Affiliation': 'Research and Nutrition Lab, Hero Group, 30820 Murcia, Spain.'}, {'ForeName': 'Julio', 'Initials': 'J', 'LastName': 'Plaza-Diaz', 'Affiliation': 'Institute of Nutrition and Food Technology ""José Mataix"", Center of Biomedical Research, University of Granada, Avda. del Conocimiento s/n., 18016 Armilla, Granada, Spain.'}, {'ForeName': 'Ángel', 'Initials': 'Á', 'LastName': 'Gil', 'Affiliation': 'Institute of Nutrition and Food Technology ""José Mataix"", Center of Biomedical Research, University of Granada, Avda. del Conocimiento s/n., 18016 Armilla, Granada, Spain.'}]",Nutrients,['10.3390/nu12061883'] 2469,32599767,"Efficacy of an Internet-Based Program to Promote Physical Activity and Exercise after Inpatient Rehabilitation in Persons with Multiple Sclerosis: A Randomized, Single-Blind, Controlled Study.","BACKGROUND Multimodal rehabilitation improves fatigue and mobility in persons with multiple sclerosis (PwMS). Effects are transient and may be conserved by internet-based physical activity promotion programs. OBJECTIVE Evaluate the effects of internet-based physical activity and exercise promotion on fatigue, quality of life, and gait in PwMS after inpatient rehabilitation. METHODS PwMS (Expanded Disability Status Scale (EDSS) ≤ 6.0, fatigue: Würzburg Fatigue Inventory for Multiple Sclerosis (WEIMuS) ≥ 32) were randomized into an intervention group (IG) or a control group (CG). After rehabilitation, IG received 3 months of internet-based physical activity promotion, while CG received no intervention. PRIMARY OUTCOME self-reported fatigue (WEIMuS). SECONDARY OUTCOMES quality of life (Multiple Sclerosis Impact Scale 29, MSIS-29), gait (2min/10m walking test, Tinetti score). MEASUREMENTS beginning (T0) and end (T1) of inpatient rehabilitation, 3 (T2) and 6 (T3) months afterwards. RESULTS 64 of 84 PwMS were analyzed (IG: 34, CG: 30). After rehabilitation, fatigue decreased in both groups. At T2 and T3, fatigue increased again in CG but was improved in IG ( p < 0.001). MSIS-29 improved in both groups at T1 but remained improved at T2 and T3 only in IG. Gait improvements were more pronounced in IG at T2. CONCLUSIONS The study provides Class II evidence that the effects of rehabilitation on fatigue, quality of life, and gait can be maintained for 3-6 months with an internet-based physical activity and exercise promotion program.",2020,MSIS-29 improved in both groups at T1 but remained improved at T2 and T3 only in IG.,"['Persons with Multiple Sclerosis', '≤ 6.0, fatigue: Würzburg Fatigue Inventory for Multiple Sclerosis (WEIMuS) ≥ 32', 'persons with multiple sclerosis (PwMS', '64 of 84 PwMS were analyzed']","['internet-based physical activity promotion, while CG received no intervention', 'Internet-Based Program to Promote Physical Activity and Exercise', 'internet-based physical activity and exercise promotion', 'intervention group (IG) or a control group (CG', 'Multimodal rehabilitation']","['Gait improvements', 'MSIS-29', 'quality of life (Multiple Sclerosis Impact Scale 29, MSIS-29), gait (2min/10m walking test, Tinetti score', 'fatigue', 'fatigue, quality of life, and gait', 'beginning (T0) and end (T1) of inpatient rehabilitation, 3 (T2) and 6 (T3) months afterwards', 'self-reported fatigue (WEIMuS', 'PwMS (Expanded Disability Status Scale (EDSS', 'fatigue and mobility', 'fatigue, quality of life, and gait in PwMS', 'fatigue increased again in CG']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0582434', 'cui_str': 'Giving encouragement to exercise'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}]","[{'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0451246', 'cui_str': 'Kurtzke multiple sclerosis rating scale'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",84.0,0.027244,MSIS-29 improved in both groups at T1 but remained improved at T2 and T3 only in IG.,"[{'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Flachenecker', 'Affiliation': 'Neurological Rehabilitation Center Quellenhof, 75323 Bad Wildbad, Germany.'}, {'ForeName': 'Anna Karoline', 'Initials': 'AK', 'LastName': 'Bures', 'Affiliation': 'Neurological Rehabilitation Center Quellenhof, 75323 Bad Wildbad, Germany.'}, {'ForeName': 'Angeli', 'Initials': 'A', 'LastName': 'Gawlik', 'Affiliation': 'Department of Health & Social Psychology, German Sport University Cologne, 50933 Cologne, Germany.'}, {'ForeName': 'Ann-Christin', 'Initials': 'AC', 'LastName': 'Weiland', 'Affiliation': 'Neurological Rehabilitation Center Quellenhof, 75323 Bad Wildbad, Germany.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Kuld', 'Affiliation': 'Faculty of Economics, University of Bayreuth, 95447 Bayreuth, Germany.'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Gusowski', 'Affiliation': 'Neurological Rehabilitation Center Quellenhof, 75323 Bad Wildbad, Germany.'}, {'ForeName': 'René', 'Initials': 'R', 'LastName': 'Streber', 'Affiliation': 'Department of Sport Science and Sport, University of Erlangen-Nuremberg, 91058 Erlangen, Germany.'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Pfeifer', 'Affiliation': 'Department of Sport Science and Sport, University of Erlangen-Nuremberg, 91058 Erlangen, Germany.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Tallner', 'Affiliation': 'Department of Sport Science and Sport, University of Erlangen-Nuremberg, 91058 Erlangen, Germany.'}]",International journal of environmental research and public health,['10.3390/ijerph17124544'] 2470,32599773,Randomized Double-Blind Controlled Trial on the Effect of Proteins with Different Tryptophan/Large Neutral Amino Acid Ratios on Sleep in Adolescents: The PROTMORPHEUS Study.,"Disturbed sleep is common in adolescents. Ingested nutrients help regulate the internal clock and influence sleep quality. The purpose of this clinical trial is to assess the effect of protein tryptophan (Trp)/large neutral amino acids (LNAAs) ratio on sleep and circadian rhythm. Ingested Trp is involved in the regulation of the sleep/wake cycle and improvement of sleep quality. Since Trp transport through the blood-brain barrier is competing with LNAAs, protein with higher Trp/LNAAs were expected to increase sleep efficiency. This randomized double-blind controlled trial will enroll two samples of male adolescents predisposed to sleep disturbances: elite rugby players (n = 24) and youths with obesity (n = 24). They will take part randomly in three sessions each held over a week. They will undergo a washout period, when dietary intake will be calibrated (three days), followed by an intervention period (three days), when their diet will be supplemented with three proteins with different Trp/LNAAs ratios. Physical, cognitive, dietary intake, appetite, and sleepiness evaluations will be made on the last day of each session. The primary outcome is sleep efficiency measured through in-home electroencephalogram recordings. Secondary outcomes include sleep staging, circadian phase, and sleep-, food intake-, metabolism-, and inflammation-related biochemical markers. A fuller understanding of the effect of protein Trp/LNAAs ratio on sleep could help in developing nutritional strategies addressing sleep disturbances.",2020,This randomized double-blind controlled trial will enroll two samples of male adolescents predisposed to sleep disturbances: elite rugby players (n = 24) and youths with obesity (n = 24).,"['Adolescents', 'male adolescents predisposed to sleep disturbances: elite rugby players (n = 24) and youths with obesity (n = 24']","['protein tryptophan (Trp)/large neutral amino acids (LNAAs) ratio', 'protein Trp/LNAAs ratio', 'Proteins with Different Tryptophan/Large Neutral Amino Acid Ratios']","['Physical, cognitive, dietary intake, appetite, and sleepiness evaluations', 'sleep efficiency measured through in-home electroencephalogram recordings', 'Disturbed sleep', 'internal clock and influence sleep quality', 'sleep staging, circadian phase, and sleep-, food intake-, metabolism-, and inflammation-related biochemical markers', 'sleep efficiency']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001589', 'cui_str': 'Adolescents, Male'}, {'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}, {'cui': 'C0035945', 'cui_str': 'Rugby'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0041249', 'cui_str': 'Tryptophan'}, {'cui': 'C0301715', 'cui_str': 'Neutral amino acid'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0549177', 'cui_str': 'Large'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0037319', 'cui_str': 'Sleep Stages'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0013470', 'cui_str': 'Eating'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0206015', 'cui_str': 'Biochemical Markers'}]",24.0,0.212532,This randomized double-blind controlled trial will enroll two samples of male adolescents predisposed to sleep disturbances: elite rugby players (n = 24) and youths with obesity (n = 24).,"[{'ForeName': 'Oussama', 'Initials': 'O', 'LastName': 'Saidi', 'Affiliation': 'Clermont Auvergne University, Laboratory of Adaptations to Exercise under Physiological and Pathological Conditions (AME2P), 63000 Clermont-Ferrand, France.'}, {'ForeName': 'Emmanuelle', 'Initials': 'E', 'LastName': 'Rochette', 'Affiliation': 'Department of Pediatrics, Clermont-Ferrand University Hospital, 63000 Clermont-Ferrand, France.'}, {'ForeName': 'Éric', 'Initials': 'É', 'LastName': 'Doré', 'Affiliation': 'Clermont Auvergne University, Laboratory of Adaptations to Exercise under Physiological and Pathological Conditions (AME2P), 63000 Clermont-Ferrand, France.'}, {'ForeName': 'Freddy', 'Initials': 'F', 'LastName': 'Maso', 'Affiliation': 'Rugby Training Center of the Sportive Association Montferrandaise, 63000 Clermont-Ferrand, France.'}, {'ForeName': 'Julien', 'Initials': 'J', 'LastName': 'Raoux', 'Affiliation': 'OXSITIS LAB-NUTRITION, Chrono-Nutrition Food Supplements, 63110 Clermont-Ferrand, France.'}, {'ForeName': 'Fabien', 'Initials': 'F', 'LastName': 'Andrieux', 'Affiliation': 'OXSITIS LAB-NUTRITION, Chrono-Nutrition Food Supplements, 63110 Clermont-Ferrand, France.'}, {'ForeName': 'Maria Livia', 'Initials': 'ML', 'LastName': 'Fantini', 'Affiliation': 'Neurophysiology Unit, Neurology Department, Clermont-Ferrand University Hospital, 63000 Clermont-Ferrand, France.'}, {'ForeName': 'Etienne', 'Initials': 'E', 'LastName': 'Merlin', 'Affiliation': 'Department of Pediatrics, Clermont-Ferrand University Hospital, 63000 Clermont-Ferrand, France.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Pereira', 'Affiliation': 'Biostatistics Unit (DRCI), Clermont-Ferrand University Hospital, 63000 Clermont-Ferrand, France.'}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Walrand', 'Affiliation': 'Clermont Auvergne University, Clermont-Ferrand University Hospital, INRAE, UNH, F-63000 Clermont-Ferrand, France.'}, {'ForeName': 'Pascale', 'Initials': 'P', 'LastName': 'Duché', 'Affiliation': 'Toulon University, Laboratory of the Impact of Physical Activity on Health (IAPS), 83000 Toulon, France.'}]",Nutrients,['10.3390/nu12061885'] 2471,32599792,Recommendations for Implementing Lung Cancer Screening with Low-Dose Computed Tomography in Europe.,"Lung cancer screening (LCS) with low-dose computed tomography (LDCT) was demonstrated in the National Lung Screening Trial (NLST) to reduce mortality from the disease. European mortality data has recently become available from the Nelson randomised controlled trial, which confirmed lung cancer mortality reductions by 26% in men and 39-61% in women. Recent studies in Europe and the USA also showed positive results in screening workers exposed to asbestos. All European experts attending the ""Initiative for European Lung Screening (IELS)""-a large international group of physicians and other experts concerned with lung cancer-agreed that LDCT-LCS should be implemented in Europe. However, the economic impact of LDCT-LCS and guidelines for its effective and safe implementation still need to be formulated. To this purpose, the IELS was asked to prepare recommendations to implement LCS and examine outstanding issues. A subgroup carried out a comprehensive literature review on LDCT-LCS and presented findings at a meeting held in Milan in November 2018. The present recommendations reflect that consensus was reached.",2020,"All European experts attending the ""Initiative for European Lung Screening (IELS)""-a large international group of physicians and other experts concerned with lung cancer-agreed that LDCT-LCS should be implemented in Europe.",['Implementing Lung Cancer Screening with Low-Dose Computed Tomography in Europe'],"['Lung cancer screening (LCS) with low-dose computed tomography (LDCT', 'IELS']",['lung cancer mortality reductions'],"[{'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C0281477', 'cui_str': 'Screening for malignant neoplasm of lung'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0015176', 'cui_str': 'Europe'}]","[{'cui': 'C0281477', 'cui_str': 'Screening for malignant neoplasm of lung'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0424093', 'cui_str': 'Initiative'}, {'cui': 'C0239307', 'cui_str': 'European'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}]","[{'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",,0.0765974,"All European experts attending the ""Initiative for European Lung Screening (IELS)""-a large international group of physicians and other experts concerned with lung cancer-agreed that LDCT-LCS should be implemented in Europe.","[{'ForeName': 'Giulia', 'Initials': 'G', 'LastName': 'Veronesi', 'Affiliation': 'Faculty of Medicine and Surgery-Vita-Salute San Raffaele University, 20132 Milan, Italy.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Baldwin', 'Affiliation': 'Department of Respiratory Medicine, David Evans Research Centre, Nottingham University Hospitals NHS Trust, Nottingham NG5 1PB, UK.'}, {'ForeName': 'Claudia I', 'Initials': 'CI', 'LastName': 'Henschke', 'Affiliation': 'Department of Radiology, Icahn School of Medicine at Mount Sinai, New York, NY 10029, USA.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Ghislandi', 'Affiliation': 'Department of Social and Political Sciences, Bocconi University, 20136 Milan, Italy.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Iavicoli', 'Affiliation': ""Department of Occupational and Environmental Medicine, Epidemiology and Hygiene, Italian Workers' Compensation Authority (INAIL), 00078 Rome, Italy.""}, {'ForeName': 'Matthijs', 'Initials': 'M', 'LastName': 'Oudkerk', 'Affiliation': 'Center for Medical Imaging, University Medical Center Groningen, University of Groningen, 9712 CP Groningen, The Netherlands.'}, {'ForeName': 'Harry J', 'Initials': 'HJ', 'LastName': 'De Koning', 'Affiliation': 'Department of Public Health, Erasmus MC-University Medical Centre Rotterdam, 3015 GD Rotterdam, The Netherlands.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Shemesh', 'Affiliation': 'The Grace Ballas Cardiac Research Unit, Sheba Medical Center, Affiliated with the Sackler Faculty of Medicine, Tel-Aviv University, 52621 Tel Aviv-Yafo, Israel.'}, {'ForeName': 'John K', 'Initials': 'JK', 'LastName': 'Field', 'Affiliation': 'Roy Castle Lung Cancer Research Programme, Department of Molecular and Clinical Cancer Medicine, The University of Liverpool, Liverpool L69 3BX, UK.'}, {'ForeName': 'Javier J', 'Initials': 'JJ', 'LastName': 'Zulueta', 'Affiliation': 'Department of Pulmonology, Clinica Universidad de Navarra, 31008 Pamplona, Spain.'}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Horgan', 'Affiliation': ""European Alliance for Personalised Medicine (EAPM), Avenue de l'Armée Legerlaan 10, 1040 Brussels, Belgium.""}, {'ForeName': 'Lucia', 'Initials': 'L', 'LastName': 'Fiestas Navarrete', 'Affiliation': 'Department of Social and Political Sciences, Bocconi University, 20136 Milan, Italy.'}, {'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Valentino Infante', 'Affiliation': 'Thoracic Surgery Department, University and Hospital Trust-Ospedale Borgo Trento, 37126 Verona, Italy.'}, {'ForeName': 'Pierluigi', 'Initials': 'P', 'LastName': 'Novellis', 'Affiliation': 'Division of Thoracic Surgery, IRCCS San Raffaele Scientific Institute, 20132 Milan, Italy.'}, {'ForeName': 'Rachael L', 'Initials': 'RL', 'LastName': 'Murray', 'Affiliation': 'Division of Epidemiology and Public Health, UK Centre for Tobacco and Alcohol Studies, Clinical Sciences Building, City Hospital, University of Nottingham, Nottingham NG5 1PB, UK.'}, {'ForeName': 'Nir', 'Initials': 'N', 'LastName': 'Peled', 'Affiliation': 'The Legacy Heritage Oncology Center & Dr. Larry Norton Institute, Soroka Medical Center & Ben-Gurion University, 84101 Beer-Sheva, Israel.'}, {'ForeName': 'Cristiano', 'Initials': 'C', 'LastName': 'Rampinelli', 'Affiliation': 'Department of Medical Imaging and Radiation Sciences, IEO European Institute of Oncology IRCCS, 20141 Milan, Italy.'}, {'ForeName': 'Gaetano', 'Initials': 'G', 'LastName': 'Rocco', 'Affiliation': 'Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, NY 10065, USA.'}, {'ForeName': 'Witold', 'Initials': 'W', 'LastName': 'Rzyman', 'Affiliation': 'Department of Thoracic Surgery, Medical University of Gdańsk, 80-210 Gdańsk, Poland.'}, {'ForeName': 'Giorgio Vittorio', 'Initials': 'GV', 'LastName': 'Scagliotti', 'Affiliation': 'Department of Oncology, University of Torino, 10124 Torino, Italy.'}, {'ForeName': 'Martin C', 'Initials': 'MC', 'LastName': 'Tammemagi', 'Affiliation': 'Department of Health Sciences, Brock University, 1812 Sir Isaac Brock Way, St Catharines, ON L2S 3A1, Canada.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Bertolaccini', 'Affiliation': 'Division of Thoracic Surgery, IEO European Institute of Oncology IRCCS, 20141 Milan, Italy.'}, {'ForeName': 'Natthaya', 'Initials': 'N', 'LastName': 'Triphuridet', 'Affiliation': 'Department of Radiology, Icahn School of Medicine at Mount Sinai, New York, NY 10029, USA.'}, {'ForeName': 'Rowena', 'Initials': 'R', 'LastName': 'Yip', 'Affiliation': 'Department of Radiology, Icahn School of Medicine at Mount Sinai, New York, NY 10029, USA.'}, {'ForeName': 'Alexia', 'Initials': 'A', 'LastName': 'Rossi', 'Affiliation': 'Department of Biomedical Sciences, Humanitas University, 20090 Pieve Emanuele (MI), Italy.'}, {'ForeName': 'Suresh', 'Initials': 'S', 'LastName': 'Senan', 'Affiliation': 'Department of Radiation Oncology, Amsterdam University Medical Centers, VU location, De Boelelaan 1117, Postbox 7057, 1007 MB Amsterdam, The Netherlands.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Ferrante', 'Affiliation': 'Department of Cardiovascular Medicine, Humanitas Clinical and Research Center IRCCS, 20089 Rozzano (MI), Italy.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Brain', 'Affiliation': 'Division of Population Medicine, School of Medicine, Cardiff University, Cardiff CF14 4YS, UK.'}, {'ForeName': 'Carlijn', 'Initials': 'C', 'LastName': 'van der Aalst', 'Affiliation': 'Department of Public Health, Erasmus MC-University Medical Centre Rotterdam, 3015 GD Rotterdam, The Netherlands.'}, {'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Bonomo', 'Affiliation': 'Department of Bioimaging and Radiological Sciences, Catholic University, 00168 Rome, Italy.'}, {'ForeName': 'Dario', 'Initials': 'D', 'LastName': 'Consonni', 'Affiliation': ""Epidemiology Unit, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, 20122 Milan, Italy.""}, {'ForeName': 'Jan P', 'Initials': 'JP', 'LastName': 'Van Meerbeeck', 'Affiliation': 'Thoracic Oncology, Antwerp University Hospital and Ghent University, 2650 Edegem, Belgium.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Maisonneuve', 'Affiliation': 'Division of Epidemiology and Biostatistics, IEO European Institute of Oncology IRCCS, 20141 Milan, Italy.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Novello', 'Affiliation': 'Department of Oncology, University of Torino, 10124 Torino, Italy.'}, {'ForeName': 'Anand', 'Initials': 'A', 'LastName': 'Devaraj', 'Affiliation': 'Department of Radiology, Royal Brompton Hospital, London SW3 6NP, UK.'}, {'ForeName': 'Zaigham', 'Initials': 'Z', 'LastName': 'Saghir', 'Affiliation': 'Department of Respiratory Medicine, Herlev-Gentofte University Hospital, 2900 Hellerup, Denmark.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Pelosi', 'Affiliation': 'Department of Oncology and Hemato-Oncology, University of Milan, 20122 Milan, Italy.'}]",Cancers,['10.3390/cancers12061672'] 2472,31357037,Imagery rescripting as an adjunct clinical intervention for obsessive compulsive disorder.,"Novel adjunct psychological techniques are needed for the large number of patients with OCD who remain symptomatic despite the effective implementation of standard evidence-based treatments. The aim of this study was to examine the efficacy of imagery rescripting (ImRs), an established technique for the treatment of traumatic stress, as a treatment for OCD symptoms that were not responsive to standard exposure and response prevention (ERP). Thirteen patients completed a baseline assessment followed by a control intervention that involved discussion of an aversive memory linked with the onset of OCD symptoms. Treatment then involved provision of 1-6 ImRs sessions; ImRs continued until patients achieved a 35% reduction in symptoms, as measured using the Y-BOCS one week after each treatment. Patients were followed up one and three months after the treatment completion. Twelve out of thirteen patients achieved ≥35% improvement in Y-BOCS. Of these patients, six required only a single ImRs session, while the remaining six patients required 2-5 ImRs sessions to achieve a clinically significant change. Lower baseline Y-BOCS predicted improvement after a single treatment session. ImRs may be a useful adjunct for treatment-resistant OCD associated with past aversive experiences, especially when symptomatology remains within the mild-moderate range after standard ERP.",2019,Thirteen patients completed a baseline assessment followed by a control intervention that involved discussion of an aversive memory linked with the onset of OCD symptoms.,"['Thirteen patients completed a baseline assessment followed by a control intervention that involved discussion of an aversive memory linked with the onset of OCD symptoms', 'obsessive compulsive disorder']",['imagery rescripting (ImRs'],[],"[{'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0557061', 'cui_str': 'Discussion'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0332162', 'cui_str': 'Onset of'}, {'cui': 'C0009595', 'cui_str': 'Obsessive compulsive personality disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0028768', 'cui_str': 'Obsessive-compulsive disorder'}]","[{'cui': 'C0150627', 'cui_str': 'Simple guided imagery'}]",[],,0.0424864,Thirteen patients completed a baseline assessment followed by a control intervention that involved discussion of an aversive memory linked with the onset of OCD symptoms.,"[{'ForeName': 'Gayle', 'Initials': 'G', 'LastName': 'Maloney', 'Affiliation': 'Yale OCD Research Clinic, United States; Perth OCD Clinic, Australia. Electronic address: gayle.maloney@yale.edu.'}, {'ForeName': 'Gennifer', 'Initials': 'G', 'LastName': 'Koh', 'Affiliation': 'Perth OCD Clinic, Australia.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Roberts', 'Affiliation': 'Perth OCD Clinic, Australia.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Pittenger', 'Affiliation': 'Yale OCD Research Clinic, United States.'}]",Journal of anxiety disorders,['10.1016/j.janxdis.2019.102110'] 2473,31364885,Cost-effectiveness of denosumab for the prevention of skeletal-related events in patients with solid tumors and bone metastases in the United States.,"Aims: Bone complications (also known as skeletal-related events [SREs]) pose significant health and financial burdens on patients with bone metastases. Denosumab demonstrated superiority over zoledronic acid in delaying the time to first SRE. This study examined the lifetime cost-effectiveness of denosumab vs zoledronic acid from both US payer and societal perspectives. Methods: This analysis used a lifetime Markov model and included patients with breast cancer, prostate cancer, and other solid tumors and bone metastases. The societal perspective included direct medical, direct non-medical, and indirect costs associated with denosumab and zoledronic acid; the payer perspective included direct medical costs only. Bone complication rates for each tumor type were estimated from three pivotal phase 3 studies and modified to reflect real-world incidence. Results: From a societal perspective, compared with zoledronic acid, denosumab use resulted in an incremental cost of $9,043, an incremental benefit of 0.128 quality-adjusted life-years (QALYs), a lifetime cost per QALY of $70,730, and a net monetary benefit (NMB) of $10,135 in favor of denosumab. Direct drug costs for denosumab ($28,352) were higher than zoledronic acid/untreated ($578), but were offset by reduced costs associated with bone complications. From a payer perspective, denosumab use was associated with an incremental cost of $13,396, and an incremental benefit of 0.128 QALYs, for a cost of $104,778 per QALY and an NMB of $5,782 in favor of denosumab. Limitations: Some model inputs had limited information and, given that the results may be sensitive to changes in these inputs, our findings should be interpreted within the context of the data inputs and modeling assumptions used in the analysis. Conclusions: Denosumab is a cost-effective option to prevent bone complications in patients with solid tumors when considering both payer and broader societal perspectives.",2020,"Direct drug costs for denosumab ($28,352) were higher than zoledronic acid/untreated ($578), but were offset by reduced costs associated with bone complications.","['patients with breast cancer, prostate cancer, and other solid tumors and bone metastases', 'patients with bone metastases', 'patients with solid tumors', 'patients with solid tumors and bone metastases in the United States']","['zoledronic acid', 'denosumab and zoledronic acid', 'denosumab vs zoledronic acid', 'denosumab', 'Denosumab']","['Direct drug costs', 'bone complications', 'Bone complication rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}, {'cui': 'C0280100', 'cui_str': 'Solid tumour'}, {'cui': 'C0153690', 'cui_str': 'Secondary malignant neoplasm of bone'}, {'cui': 'C1301808', 'cui_str': 'State'}]","[{'cui': 'C0257685', 'cui_str': 'zoledronic acid'}, {'cui': 'C1690432', 'cui_str': 'denosumab'}]","[{'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0085123', 'cui_str': 'Drug Costs'}, {'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",,0.044035,"Direct drug costs for denosumab ($28,352) were higher than zoledronic acid/untreated ($578), but were offset by reduced costs associated with bone complications.","[{'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Stopeck', 'Affiliation': 'Division of Hematology/Oncology, Stony Brook Cancer Center, Stony Brook, NY, USA.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Brufsky', 'Affiliation': 'Division of Hematology/Oncology, University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Kennedy', 'Affiliation': 'Epiphany, Los Angeles, CA, USA.'}, {'ForeName': 'Sumi', 'Initials': 'S', 'LastName': 'Bhatta', 'Affiliation': 'Global Health Economics, Amgen Inc, Thousand Oaks, CA, USA.'}, {'ForeName': 'Debajyoti', 'Initials': 'D', 'LastName': 'Bhowmik', 'Affiliation': 'Global Health Economics, Amgen Inc, Thousand Oaks, CA, USA.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Buchanan', 'Affiliation': 'Global Health Economics, Amgen Inc, Thousand Oaks, CA, USA.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Despiegel', 'Affiliation': 'Global Health Economics, Amgen Inc, Thousand Oaks, CA, USA.'}, {'ForeName': 'Guy', 'Initials': 'G', 'LastName': 'Hechmati', 'Affiliation': 'Global Health Economics, Amgen Inc, Thousand Oaks, CA, USA.'}]",Journal of medical economics,['10.1080/13696998.2019.1651122'] 2474,31578113,Prospective cost analysis of early video capsule endoscopy versus standard of care in non-hematemesis gastrointestinal bleeding: a non-inferiority study.,"Background and aim: A non-inferiority cost analysis was performed to assess if the early capsule approach would incur higher costs than the standard of care approach in patients presenting with non-hematemesis gastrointestinal bleeding. Methods: A prospective non-inferiority cost analysis was performed on patients receiving either an early video capsule as the first diagnostic procedure or an endoscopic procedure as determined by gastroenterology staff that were not involved in the study. Primary outcome was total direct costs incurred in both groups. Results: Forty-five patients and 42 patients were enrolled into the early capsule and standard of care arms, respectively. There was no difference in total direct cost per inpatient case in both groups ($7,362 vs $7,148, p  = 0.77 [CI = -2,285-2,315, equivalent margin = -$3,100]). Localization of a bleeding source after the first diagnostic procedure was identified more frequently in the early capsule group (69.2% vs 27.9%, p  = 0.0003). If patients were discharged after their last non-diagnostic evaluation, then length of stay could be decreased by 50% in both groups (58.5 to 31.6 h, p  = 0.02 in the early capsule group and 69.4 to 39.2 h in the standard of care group p  = 0.001). Projections indicate the fastest a patient with non-diagnostic evaluations could be discharged is 0.88 days in the early capsule group vs 1.63 days in the standard of care group ( p  = 0.0005). Discussion: In patients with non-hematemesis bleeding, video capsule endoscopy may be a more efficient diagnostic approach than the standard of care approach, since it detects bleeding significantly more often without an increase in healthcare costs.",2020,"There was no difference in total direct cost per inpatient case in both groups ($7,362 vs $7,148, p  = 0.77 [CI = -2,285-2,315, equivalent margin = -$3,100]).","['Forty-five patients and 42 patients were enrolled into the early capsule and standard of care arms, respectively', 'patients presenting with non-hematemesis gastrointestinal bleeding', 'patients receiving either an early video capsule as the first diagnostic procedure or an endoscopic procedure as determined by gastroenterology staff that were not involved in the study']",['early video capsule endoscopy versus standard of care'],"['Localization of a bleeding source', 'length of stay', 'total direct cost', 'total direct costs']","[{'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0018926', 'cui_str': 'Hematemesis'}, {'cui': 'C0017181', 'cui_str': 'Gastrointestinal hemorrhage'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0430022', 'cui_str': 'Diagnostic procedure'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0017163', 'cui_str': 'Gastroenterology'}, {'cui': 'C2700616', 'cui_str': 'Manpower'}, {'cui': 'C0205429', 'cui_str': 'Uninvolved'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C1721048', 'cui_str': 'Capsule endoscopy'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}]","[{'cui': 'C0037710', 'cui_str': 'Auditory localization'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0449416', 'cui_str': 'Source'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0010186', 'cui_str': 'Cost'}]",,0.135515,"There was no difference in total direct cost per inpatient case in both groups ($7,362 vs $7,148, p  = 0.77 [CI = -2,285-2,315, equivalent margin = -$3,100]).","[{'ForeName': 'Salmaan', 'Initials': 'S', 'LastName': 'Jawaid', 'Affiliation': 'Division of Gastroenterology, Department of Internal Medicine, University of Florida College of Medicine, Gainesville, FL, USA.'}, {'ForeName': 'Neil B', 'Initials': 'NB', 'LastName': 'Marya', 'Affiliation': 'Division of Gastroenterology, Department of Internal Medicine, University of California Los Angeles Medical Center, Los Angeles, CA, USA.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Hicks', 'Affiliation': 'Department of Financial Reporting, University of Massachusetts Medical Center, Worcester, MA, USA.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Marshall', 'Affiliation': 'Division of Gastroenterology, Department of Internal Medicine, University of Massachusetts Medical School, Worcester, MA, USA.'}, {'ForeName': 'Kanishka', 'Initials': 'K', 'LastName': 'Bhattacharya', 'Affiliation': 'Division of Gastroenterology, Department of Internal Medicine, University of Massachusetts Medical School, Worcester, MA, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Cave', 'Affiliation': 'Division of Gastroenterology, Department of Internal Medicine, University of Massachusetts Medical School, Worcester, MA, USA.'}]",Journal of medical economics,['10.1080/13696998.2019.1675671'] 2475,32603789,Digoxin Initiation and Outcomes in Patients with Heart Failure (HFrEF and HFpEF) and Atrial Fibrillation.,"BACKGROUND Digoxin reduces the risk of heart failure hospitalization but has no effect on mortality in patients with heart failure without atrial fibrillation in the randomized controlled trial setting. Observational studies of digoxin use in patients with atrial fibrillation have suggested a higher risk for poor outcomes. Less is known about this association in patients with heart failure and atrial fibrillation, the examination of which was the objective of the current study. METHODS We conducted an observational propensity score-matched study of pre-discharge digoxin initiation in 1768 hospitalized patients with heart failure and atrial fibrillation in Medicare-linked OPTIMIZE-HF registry, balanced on 56 baseline characteristics (mean age, 79 years; 55% women; 7% African American). Hazard ratios (HRs) and 95% confidence intervals (CIs) for outcomes were estimated for the 884 patients initiated on digoxin compared with 884 not initiated on digoxin. RESULTS HRs (95% CIs) for 30-day, 2-year, and 4-year all-cause mortality were 0.80 (0.55-1.18; p=0.261), 0.94 (0.87-1.16; p=0.936), and 1.01 (0.90-1.14; p=0.729), respectively. Respective HRs (95% CIs) for heart failure readmission were 0.67 (0.49-0.92; p=0.014), 0.81 (0.69-0.94; p=0.005), and 0.85 (0.74-0.97; p=0.022), and those for all-cause readmission were 0.78 (0.64-0.96; p=0.016), 0.90 (0.81-1.00; p=0.057), and 0.91 (0.83-1.01; p=0.603). These associations were homogeneous between patients with left ventricular ejection fraction ≤45% versus >45%. CONCLUSIONS Among hospitalized older patients with HFrEF and HFpEF and atrial fibrillation, initiation of digoxin was associated with a lower risk of heart failure readmission but had no association with mortality.",2020,"Respective HRs (95% CIs) for heart failure readmission were 0.67 (0.49-0.92; p=0.014), 0.81 (0.69-0.94; p=0.005), and 0.85 (0.74-0.97; p=0.022), and those for all-cause readmission were 0.78 (0.64-0.96; p=0.016), 0.90 (0.81-1.00; p=0.057), and 0.91","['1768 hospitalized patients with heart failure and atrial fibrillation in Medicare-linked OPTIMIZE-HF registry, balanced on 56 baseline characteristics (mean age, 79 years; 55% women; 7% African American', 'Patients with Heart Failure ', 'patients with heart failure and atrial fibrillation', '884 patients initiated on', 'patients with atrial fibrillation', 'hospitalized older patients with HFrEF and HFpEF and atrial fibrillation, initiation of', 'patients with heart failure without atrial fibrillation']","['pre-discharge digoxin initiation', 'digoxin', 'HFrEF and HFpEF', 'Digoxin']","['heart failure readmission', '30-day, 2-year, and 4-year all-cause mortality', 'Hazard ratios (HRs) and 95% confidence intervals (CIs) for outcomes']","[{'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0018717', 'cui_str': 'Health Insurance for Aged and Disabled, Title 18'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0085756', 'cui_str': 'African American'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}]","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0012265', 'cui_str': 'Digoxin'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}]","[{'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0009667', 'cui_str': 'Confidence Intervals'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",1768.0,0.168502,"Respective HRs (95% CIs) for heart failure readmission were 0.67 (0.49-0.92; p=0.014), 0.81 (0.69-0.94; p=0.005), and 0.85 (0.74-0.97; p=0.022), and those for all-cause readmission were 0.78 (0.64-0.96; p=0.016), 0.90 (0.81-1.00; p=0.057), and 0.91","[{'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Singh', 'Affiliation': 'Veterans Affairs Medical Center, Washington, DC; Georgetown University, Washington, DC.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Moore', 'Affiliation': 'Veterans Affairs Medical Center, Washington, DC; Georgetown University, Washington, DC.'}, {'ForeName': 'Pamela A', 'Initials': 'PA', 'LastName': 'Karasik', 'Affiliation': 'Veterans Affairs Medical Center, Washington, DC; George Washington University, Washington, DC.'}, {'ForeName': 'Phillip H', 'Initials': 'PH', 'LastName': 'Lam', 'Affiliation': 'Veterans Affairs Medical Center, Washington, DC; Georgetown University, Washington, DC; MedStar Washington Hospital Center, Washington, DC.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Wopperer', 'Affiliation': 'Veterans Affairs Medical Center, Washington, DC; Georgetown University, Washington, DC.'}, {'ForeName': 'Cherinne', 'Initials': 'C', 'LastName': 'Arundel', 'Affiliation': 'Veterans Affairs Medical Center, Washington, DC; Georgetown University, Washington, DC; George Washington University, Washington, DC.'}, {'ForeName': 'Lakshmi', 'Initials': 'L', 'LastName': 'Tummala', 'Affiliation': 'Veterans Affairs Medical Center, Washington, DC; Georgetown University, Washington, DC; George Washington University, Washington, DC.'}, {'ForeName': 'Markus S', 'Initials': 'MS', 'LastName': 'Anker', 'Affiliation': 'Charité Campus Virchow Klinikum, Berlin, Germany; Charité Campus Benjamin Franklin, Berlin, Germany; Berlin Institute of Health Center for Regenerative Therapies, Berlin, Germany; German Centre for Cardiovascular Research, Berlin, Germany.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Faselis', 'Affiliation': 'Veterans Affairs Medical Center, Washington, DC; George Washington University, Washington, DC.'}, {'ForeName': 'Prakash', 'Initials': 'P', 'LastName': 'Deedwania', 'Affiliation': 'Veterans Affairs Medical Center, Washington, DC; University of California, San Francisco, CA.'}, {'ForeName': 'Charity J', 'Initials': 'CJ', 'LastName': 'Morgan', 'Affiliation': 'Veterans Affairs Medical Center, Washington, DC; University of Alabama at Birmingham, Birmingham, AL.'}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Zeng', 'Affiliation': 'Veterans Affairs Medical Center, Washington, DC; George Washington University, Washington, DC.'}, {'ForeName': 'Richard M', 'Initials': 'RM', 'LastName': 'Allman', 'Affiliation': 'George Washington University, Washington, DC; University of Alabama at Birmingham, Birmingham, AL.'}, {'ForeName': 'Gregg C', 'Initials': 'GC', 'LastName': 'Fonarow', 'Affiliation': 'University of California, Los Angeles, CA.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Ahmed', 'Affiliation': 'Veterans Affairs Medical Center, Washington, DC; Georgetown University, Washington, DC; George Washington University, Washington, DC. Electronic address: ali.ahmed@va.gov.'}]",The American journal of medicine,['10.1016/j.amjmed.2020.05.030'] 2476,32603873,An Initial Psychometric Evaluation of the Pain Concepts Questionnaire in a Low-SES Setting.,"The examination of pain beliefs for chronic pain assessment and treatment has been a growing area of interest. A variety of questionnaires have been developed to assess pain beliefs, however, these questionnaires often require high levels of literacy and education. The Pain Concepts Questionnaire (PCQ) was developed with literacy-adaptations to better evaluate pain beliefs in a low socioeconomic (SES) population. This study is an initial exploratory evaluation of the PCQ in a sample of patients with chronic pain and multiple disparities as part of the Learning About My Pain (LAMP) trial, a randomized controlled trial comparing literacy-adapted psychosocial treatments for chronic pain. All data were collected at pre-treatment. Exploratory factor analysis (EFA) was performed to examine the underlying factor structure of the PCQ and cross-sectional correlational analyses examined relationships between pain beliefs with sociodemographic factors and chronic pain-related variables. Results suggested a 2-factor solution with a Biopsychosocial factor and Biomedical factor. Consistent with the literature, correlational analyses highlighted racial and SES disparities in pain beliefs and the importance of beliefs in pain- and cognitive/affective-related functioning. The study emphasizes the importance of pain beliefs in chronic pain management and recommends future research to further examine additional psychometric properties of the PCQ.",2020,"Consistent with the literature, correlational analyses highlighted racial and SES disparities in pain beliefs and the importance of beliefs in pain- and cognitive/affective-related functioning.","['patients with chronic pain and multiple disparities as part of the Learning About My Pain (LAMP) trial', 'chronic pain']","['literacy-adapted psychosocial treatments', 'PCQ']","['pain beliefs', 'Pain Concepts Questionnaire (PCQ']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0023864', 'cui_str': 'Literacy'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",,0.0609843,"Consistent with the literature, correlational analyses highlighted racial and SES disparities in pain beliefs and the importance of beliefs in pain- and cognitive/affective-related functioning.","[{'ForeName': 'Andrea K', 'Initials': 'AK', 'LastName': 'Newman', 'Affiliation': 'Department of Psychology, University of Alabama. Electronic address: anewman@crimson.ua.edu.'}, {'ForeName': 'Calia A', 'Initials': 'CA', 'LastName': 'Morais', 'Affiliation': 'Department of Community Dentistry and Behavioral Science & Pain Research and Intervention Center of Excellence, University of Florida. Electronic address: cmorais@dental.ufl.edu.'}, {'ForeName': 'Benjamin P', 'Initials': 'BP', 'LastName': 'Van Dyke', 'Affiliation': 'Department of Psychology, Young Harris College. Electronic address: bpvandyke@yhc.edu.'}, {'ForeName': 'Beverly E', 'Initials': 'BE', 'LastName': 'Thorn', 'Affiliation': 'Department of Psychology, University of Alabama. Electronic address: bthorn@ua.edu.'}]",The journal of pain : official journal of the American Pain Society,['10.1016/j.jpain.2020.05.002'] 2477,32604135,The Effectiveness of a New Dispatcher-Assisted Basic Life Support Training Program on Quality in Cardiopulmonary Resuscitation Performance During Training and Willingness to Perform Bystander Cardiopulmonary Resuscitation: A Cluster Randomized Controlled Study.,"INTRODUCTION A new dispatcher-assisted basic life support training program, called ""Home Education and Resuscitation Outcome Study (HEROS)"" was developed with a goal to provide high-quality dispatcher-assisted cardiopulmonary resuscitation (CPR) training, with a focus on untrained home bystanders. This study aimed to determine whether the HEROS program is associated with improved quality in CPR performance during training and willingness to provide bystander CPR compared with other basic life support programs without dispatcher-assisted CPR (non-HEROS). METHODS This clustered randomized trial was conducted in 3 district health centers in Seoul. Intervention group was trained with the HEROS program and control group was trained with non-HEROS program. The primary outcome was overall CPR quality, measured as total CPR score. Secondary outcomes were other CPR quality parameters including average compression depth and rate, percentages of adequate depth, and acceptable release. Tertiary outcomes were posttraining survey results. Difference in difference analysis was performed to analyze the outcomes. RESULTS Among total 1929 trainees, 907 (47.0%) were trained with HEROS program. Compared with the non-HEROS group, the HEROS group showed higher-quality CPR performances and better maintenance of their CPR quality throughout the course (total scores of 84% vs. 80% for first session and 72% vs. 67% for last session; difference in difference of 12.2 vs. 13.2). Other individual CPR parameters also showed significantly higher quality in the HEROS group. The posttraining survey showed that both groups were highly willing to perform bystander CPR (91.4% in the HEROS vs. 92.3% in the non-HEROS) with only 3.4% of respondents in the HEROS group were not willing to volunteer compared with 6.2% in the non-HEROS group (P < 0.01). CONCLUSIONS The HEROS training program helped trainees perform high-quality CPR throughout the course and enhanced their willingness to provide bystander CPR.",2020,"Compared with the non-HEROS group, the HEROS group showed higher-quality CPR performances and better maintenance of their CPR quality throughout the course (total scores of 84% vs. 80% for first session and 72% vs. 67% for last session; difference in difference of 12.2 vs. 13.2).","['3 district health centers in Seoul', 'Among total 1929 trainees, 907 (47.0%) were trained with HEROS program']","['New Dispatcher-Assisted Basic Life Support Training Program', 'Bystander Cardiopulmonary Resuscitation', 'HEROS program and control group was trained with non-HEROS program', 'quality dispatcher-assisted cardiopulmonary resuscitation (CPR) training', 'HEROS program']","['total CPR score', 'CPR quality', 'quality CPR performances', 'overall CPR quality', 'CPR quality parameters including average compression depth and rate, percentages of adequate depth, and acceptable release', 'bystander CPR', 'Quality in Cardiopulmonary Resuscitation Performance']","[{'cui': 'C0475309', 'cui_str': 'Health center'}, {'cui': 'C3850150', 'cui_str': 'Seoul'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0085873', 'cui_str': 'Basic life support'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0332306', 'cui_str': 'Quality'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C3539083', 'cui_str': 'Acceptable'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}]",1929.0,0.0326558,"Compared with the non-HEROS group, the HEROS group showed higher-quality CPR performances and better maintenance of their CPR quality throughout the course (total scores of 84% vs. 80% for first session and 72% vs. 67% for last session; difference in difference of 12.2 vs. 13.2).","[{'ForeName': 'Gwan Jin', 'Initials': 'GJ', 'LastName': 'Park', 'Affiliation': 'From the Department of Emergency Medicine (G.J.P.), Chungbuk National University Hospital, Cheongju; Seoul National University Hospital Biomedical Research Institute; Department of Emergency Medicine (K.J.S.), Seoul National University Boramae Medical Center; Department of Emergency Medicine (S.D.S.), Seoul National University College of Medicine and Hospital; Department of Emergency Medicine (T.H.K.), Seoul National University Hospital; Laboratory of Emergency Medical Services (Y.S.R.), Seoul National University Boramae Medical Center Strategic Research, Laerdal Medical (S.Y.J.K., H.M., T.S.B.), Stavanger, Norway.'}, {'ForeName': 'So Yeon Joyce', 'Initials': 'SYJ', 'LastName': 'Kong', 'Affiliation': ''}, {'ForeName': 'Kyoung Jun', 'Initials': 'KJ', 'LastName': 'Song', 'Affiliation': ''}, {'ForeName': 'Sang Do', 'Initials': 'SD', 'LastName': 'Shin', 'Affiliation': ''}, {'ForeName': 'Tae Han', 'Initials': 'TH', 'LastName': 'Kim', 'Affiliation': ''}, {'ForeName': 'Young Sun', 'Initials': 'YS', 'LastName': 'Ro', 'Affiliation': ''}, {'ForeName': 'Helge', 'Initials': 'H', 'LastName': 'Myklebust', 'Affiliation': ''}, {'ForeName': 'Tonje Soraas', 'Initials': 'TS', 'LastName': 'Birkenes', 'Affiliation': ''}]",Simulation in healthcare : journal of the Society for Simulation in Healthcare,['10.1097/SIH.0000000000000435'] 2478,32604148,"Daily Undulating Periodization Is More Effective Than Nonperiodized Training on Maximal Strength, Aerobic Capacity, and TCD4+ Cell Count in People Living With HIV.","Soares, VL, Soares, WF, Zanetti, HR, Neves, FF, Silva-Vergara, ML, and Mendes, EL. Daily undulating periodization is more effective than nonperiodized training on maximal strength, aerobic capacity, and TCD4+ cell count in people living with HIV. J Strength Cond Res XX(X): 000-000, 2020-The aim of this study was to evaluate the effects of daily undulating periodization (DUP) and nonperiodized training (NPT) programs on maximal muscle strength, body composition, aerobic capacity, muscle power, and immune markers in people living with HIV (PLWHIV). A total of 41 PLWHIV were randomly assigned to control (CON [n = 15]), DUP (n = 13), and NPT (n = 13) groups. The DUP and NPT groups performed combined training 3 times a week on nonconsecutive days during 12 weeks, whereas the CON group was asked to maintain their current level of activity. After the 12-week training program, DUP produced greater gains in muscle strength (except for bench press), V[Combining Dot Above]O2peak, and muscle power than NPT (p < 0.05). Compared to CON, the training groups showed significantly (p < 0.05) increased muscle strength (DUP = 31.0 ± 13.9 kg; NPT = 17.7 ± 9.2 kg; CON = -0.3 ± 1.5 kg), fat-free mass (DUP = 1.9 ± 1.5 kg; NPT = 1.4 ± 1.9 kg; CON = -0.1 ± 1.2 kg), and metabolic equivalent (DUP = 2.3 ± 1.3; NPT = 1.8 ± 1.9), and decreased body fat mass (DUP = -2.1 ± 1.6 kg; NPT = -1.4 ± 1.5 kg; CON = 0.1 ± 0.2) and functional aerobic impairment (DUP = -35.9 ± 17.0%; NPT = -25.8 ± 22.0%; CON = 0.8 ± 3.0%). There was an increase in TCD4 cells only in the DUP group (p < 0.05). The training effect generally provided a positive correlation between change in leg press strength (r = 0.393, p < 0.05), triceps pulley strength (r = 0.417, p < 0.05), lat pull-down strength (r = 0.459, p < 0.05), and muscle power (r = 0.324, p < 0.05) with changing CD4 + lymphocyte count. Daily undulating periodization protocol showed to be safe, applicable, and more efficient for increasing strength, aerobic capacity, and TCD4 cells compared to NPT in PLWHIV.",2020,"Compared to CON, the training groups showed significantly (p < 0.05) increased muscle strength (DUP = 31.0 ± 13.9 kg; NPT = 17.7 ± 9.2 kg; CON = -0.3 ± 1.5 kg), fat-free mass (DUP = 1.9 ± 1.5 kg; NPT = 1.4 ± 1.9 kg; CON = -0.1 ± 1.2 kg), and metabolic equivalent (DUP = 2.3 ± 1.3; NPT = 1.8 ± 1.9), and decreased body fat mass (DUP = -2.1 ± 1.6 kg; NPT = -1.4 ± 1.5 kg; CON = 0.1 ± 0.2) and functional aerobic impairment (DUP = -35.9 ± 17.0%; NPT = -25.8 ± 22.0%; CON = 0.8 ± 3.0%).","['People Living With HIV', 'A total of 41 PLWHIV', 'people living with HIV', 'people living with HIV (PLWHIV']","['J Strength Cond Res XX(X', 'Nonperiodized Training', 'NPT', 'DUP', 'nonperiodized training', 'CON', 'daily undulating periodization (DUP) and nonperiodized training (NPT) programs']","['triceps pulley strength', 'Maximal Strength, Aerobic Capacity, and TCD4+ Cell Count', 'TCD4 cells', 'functional aerobic impairment', 'lat pull-down strength', 'maximal strength, aerobic capacity, and TCD4+ cell count', 'maximal muscle strength, body composition, aerobic capacity, muscle power, and immune markers', 'strength, aerobic capacity, and TCD4 cells', 'muscle strength', 'Soares, VL, Soares, WF, Zanetti, HR, Neves, FF, Silva-Vergara, ML, and Mendes, EL', 'muscle power', 'leg press strength', 'body fat mass']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0439810', 'cui_str': 'Total'}]","[{'cui': 'C1856054', 'cui_str': 'Hutterite cerebroosteonephrodysplasia syndrome'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0023979', 'cui_str': 'Thyroid Stimulator, Long-Acting'}, {'cui': 'C0580846', 'cui_str': 'Does pull'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0427052', 'cui_str': 'Finding of power of skeletal muscle'}, {'cui': 'C0162489', 'cui_str': 'Immunologic Marker'}, {'cui': 'C0574516', 'cui_str': 'Mende language'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}]",41.0,0.0158787,"Compared to CON, the training groups showed significantly (p < 0.05) increased muscle strength (DUP = 31.0 ± 13.9 kg; NPT = 17.7 ± 9.2 kg; CON = -0.3 ± 1.5 kg), fat-free mass (DUP = 1.9 ± 1.5 kg; NPT = 1.4 ± 1.9 kg; CON = -0.1 ± 1.2 kg), and metabolic equivalent (DUP = 2.3 ± 1.3; NPT = 1.8 ± 1.9), and decreased body fat mass (DUP = -2.1 ± 1.6 kg; NPT = -1.4 ± 1.5 kg; CON = 0.1 ± 0.2) and functional aerobic impairment (DUP = -35.9 ± 17.0%; NPT = -25.8 ± 22.0%; CON = 0.8 ± 3.0%).","[{'ForeName': 'Vitor Lopes', 'Initials': 'VL', 'LastName': 'Soares', 'Affiliation': 'Exercise Science, Health and Human Performance Research Group, Department of Sport Sciences, Postgraduate Program in Physical Education, Federal University of Triângulo Mineiro, Uberaba, MG, Brazil.'}, {'ForeName': 'Weverton Fonseca', 'Initials': 'WF', 'LastName': 'Soares', 'Affiliation': 'Exercise Science, Health and Human Performance Research Group, Department of Sport Sciences, Postgraduate Program in Physical Education, Federal University of Triângulo Mineiro, Uberaba, MG, Brazil.'}, {'ForeName': 'Hugo Ribeiro', 'Initials': 'HR', 'LastName': 'Zanetti', 'Affiliation': 'Department of Physical Education, Master Institute of Education President Antônio Carlos, Araguari, MG, Brazil.'}, {'ForeName': 'Fernando Freitas', 'Initials': 'FF', 'LastName': 'Neves', 'Affiliation': 'Department of Medical Clinics, Institute of Health Sciences, Clinics Hospital, Federal University of Triângulo Mineiro, Uberaba, MG, Brazil.'}, {'ForeName': 'Mário Leon', 'Initials': 'ML', 'LastName': 'Silva-Vergara', 'Affiliation': 'Department of Medical Clinics, Institute of Health Sciences, Clinics Hospital, Federal University of Triângulo Mineiro, Uberaba, MG, Brazil.'}, {'ForeName': 'Edmar Lacerda', 'Initials': 'EL', 'LastName': 'Mendes', 'Affiliation': 'Exercise Science, Health and Human Performance Research Group, Department of Sport Sciences, Postgraduate Program in Physical Education, Federal University of Triângulo Mineiro, Uberaba, MG, Brazil.'}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000003675'] 2479,32604202,Video Virtual Clinical Encounters Versus Office Visits for Postoperative Care After Pelvic Organ Prolapse Surgery: A Randomized Clinical Trial.,"OBJECTIVES To determine if patient satisfaction of virtual clinical encounters is noninferior to traditional in-office clinical encounters for postoperative follow-up after reconstructive surgery for pelvic organ prolapse. METHODS This was a randomized controlled noninferiority trial of women undergoing surgery for pelvic organ prolapse. Women were recruited and randomized during their preoperative counseling visit to virtual clinical encounters via video conference technology or in-office clinical encounters for their 30-day postoperative follow-up visits. The primary outcome was patient satisfaction measured by the validated Patient Satisfaction Questionnaire-18 (score range, 18-90, with higher scores indicating greater satisfaction) administered by telephone following the 30-day visit. Additional information regarding demographics, postoperative health care utilization, and complications was collected via chart review and compared between groups. RESULTS A total of 52 women were randomly assigned to virtual clinical encounters via videoconference technology or traditional in-office clinical encounters (26 per group). The mean patient satisfaction score was 80.7 ± 2.6 in the virtual group and 81.2 ± 2.8 in the office group (difference, -0.46 points; 95% confidence interval, -1.95 to 1.03), which was consistent with noninferiority. Postoperative complication rates were 31% in the virtual group and 46% in the office group (P = 0.3). There were no significant between-group differences in secondary measures of unscheduled telephone calls (88% versus 77%, P = 0.5) and office visits (35% versus 38%, P = 0.8), emergency room visits (15% versus 19%, P = 1.0), and hospital readmissions (4% versus 12%, P = 0.6) within 90 days of surgery. CONCLUSIONS For patients with pelvic organ prolapse undergoing reconstructive surgery, postoperative virtual clinical encounters via video conference technology are noninferior to traditional in-office clinical encounters with high levels of short-term patient satisfaction and no differences in postoperative health care utilization and complications rates.",2020,Postoperative complication rates were 31% in the virtual group and 46% in the office group (P = 0.3).,"['women undergoing surgery for pelvic organ prolapse', 'A total of 52 women', 'After Pelvic Organ Prolapse Surgery', 'patients with pelvic organ prolapse undergoing reconstructive surgery, postoperative virtual clinical encounters']","['virtual clinical encounters via videoconference technology or traditional in-office clinical encounters', 'preoperative counseling visit to virtual clinical encounters via video conference technology or in-office clinical encounters']","['secondary measures of unscheduled telephone calls', 'office visits', 'emergency room visits', 'hospital readmissions', 'mean patient satisfaction score', 'patient satisfaction measured by the validated Patient Satisfaction Questionnaire-18', 'Postoperative complication rates']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0877015', 'cui_str': 'Urogenital prolapse'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0524865', 'cui_str': 'Reconstruction - action'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1450049', 'cui_str': 'Videoconference'}, {'cui': 'C0039421', 'cui_str': 'Technology'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C0920638', 'cui_str': 'Preoperative counseling'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0086047', 'cui_str': 'Conferences'}]","[{'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C3854240', 'cui_str': 'Unscheduled'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0028900', 'cui_str': 'Office visit'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0600290', 'cui_str': 'Hospital re-admission'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0451370', 'cui_str': 'Patient satisfaction score'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}]",52.0,0.341459,Postoperative complication rates were 31% in the virtual group and 46% in the office group (P = 0.3).,"[{'ForeName': 'Daniel D', 'Initials': 'DD', 'LastName': 'Lee', 'Affiliation': 'From the Division of Urogynecology, Department of Obstetrics and Gynecology, Kaiser Permanente, Northwest, Clackamas, OR.'}, {'ForeName': 'Lily A', 'Initials': 'LA', 'LastName': 'Arya', 'Affiliation': 'Division of Female Pelvic Medicine and Reconstructive Surgery, Department of Obstetrics and Gynecology, University of Pennsylvania School of Medicine, Philadelphia, PA.'}, {'ForeName': 'Uduak U', 'Initials': 'UU', 'LastName': 'Andy', 'Affiliation': 'Division of Female Pelvic Medicine and Reconstructive Surgery, Department of Obstetrics and Gynecology, University of Pennsylvania School of Medicine, Philadelphia, PA.'}, {'ForeName': 'Heidi S', 'Initials': 'HS', 'LastName': 'Harvie', 'Affiliation': 'Division of Female Pelvic Medicine and Reconstructive Surgery, Department of Obstetrics and Gynecology, University of Pennsylvania School of Medicine, Philadelphia, PA.'}]",Female pelvic medicine & reconstructive surgery,['10.1097/SPV.0000000000000909'] 2480,32604224,The Effect of Xinmailong Infusion on Sepsis-Induced Myocardial Dysfunction: A Pragmatic Randomized Controlled Trial.,"Sepsis-induced myocardial dysfunction (SIMD) contributes significantly to cardiovascular dysfunction during septic shock. We aimed to evaluate the potential role of Xinmailong injection (XMLI), a polypeptide medicine extracted from Periplaneta americana, in reversing the progression of myocardial damage to SIMD in sepsis patients. This was a multicenter, randomized, double-blind, parallel-group trial. We recruited all patients consecutively admitted to intensive care units (ICUs) who were aged 18-85 years old and met the sepsis 3.0 criteria. The primary outcome measure was the incidence of sepsis-induced myocardial dysfunction while in the ICU. Of the 192 patients, 96 were assigned to the treatment group, and 96 to the control group. Subsequently, 41 patients [41/96 (42.7%)] in the XMLI group and 61 patients in the placebo group [61/96 (63.5%)] were confirmed to have diastolic dysfunction on the fifth day (D5). The incidence of diastolic SIMD was significantly different between the two groups (P = 0.004). There were 36 deaths in the two groups during the 28-day follow-up, with a general mortality rate of 18.8% (36/192). The 28-day mortality rates were not significantly different between the groups (P = 0.45). However, the brain natriuretic peptide (BNP) plasma concentration trends on D0, D2, and D5 significantly differed between the two groups (P = 0.049). In septic patients, XMLI decreased the occurrence rate of diastolic SIMD more effectively than the placebo. The improvement in serum BNP concentration was also greater in the XMLI group. XMLI may, therefore, effectively and safely improve cardiac function in patients with sepsis.",2020,The 28-day mortality rates were not significantly different between the groups (P = 0.45).,"['patients with sepsis', '192 patients, 96 were assigned to the treatment group, and 96 to the control group', 'patients consecutively admitted to intensive care units (ICUs) who were aged 18-85 years old and met the sepsis 3.0 criteria', 'sepsis patients']","['placebo', 'Xinmailong injection (XMLI', 'XMLI', 'Xinmailong Infusion']","['diastolic dysfunction', 'incidence of sepsis-induced myocardial dysfunction', 'occurrence rate of diastolic SIMD', 'serum BNP concentration', '28-day mortality rates', 'incidence of diastolic SIMD', 'Sepsis-Induced Myocardial Dysfunction', 'cardiac function', 'brain natriuretic peptide (BNP) plasma concentration trends on D0, D2, and D5', 'general mortality rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}, {'cui': 'C4517623', 'cui_str': '192'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0583239', 'cui_str': 'Admission to intensive care unit'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4506833', 'cui_str': 'xinmailong'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}]","[{'cui': 'C0520863', 'cui_str': 'Diastolic dysfunction'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0340515', 'cui_str': 'Myocardial dysfunction'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0054015', 'cui_str': 'Nesiritide'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0232164', 'cui_str': 'Cardiac function'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0040833', 'cui_str': 'trends'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}]",192.0,0.25169,The 28-day mortality rates were not significantly different between the groups (P = 0.45).,"[{'ForeName': 'Jianzhuo', 'Initials': 'J', 'LastName': 'He', 'Affiliation': 'Department of Critical Care Medicine, The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China.'}, {'ForeName': 'Xujie', 'Initials': 'X', 'LastName': 'Zhao', 'Affiliation': 'Department of Critical Care Medicine, The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China.'}, {'ForeName': 'Xinfeng', 'Initials': 'X', 'LastName': 'Lin', 'Affiliation': 'Department of Critical Care Medicine, The First Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China.'}, {'ForeName': 'Zhixu', 'Initials': 'Z', 'LastName': 'Yang', 'Affiliation': 'Department of Critical Care Medicine, Xiyuan Hospital of China Academy of Chinese Medical Science, Beijing, China.'}, {'ForeName': 'Mingyuan', 'Initials': 'M', 'LastName': 'Ma', 'Affiliation': 'Department of Critical Care Medicine, Foshan Hospital of Traditional Chinese Medicine, Foshan, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Ma', 'Affiliation': 'Department of Critical Care Medicine, Lanzhou University Second Hospital, Lanzhou, China.'}, {'ForeName': 'Qun', 'Initials': 'Q', 'LastName': 'Liang', 'Affiliation': 'Department of Critical Care Medicine, The First Affiliated Hospital of Heilongjiang University of Chinese Medicine, Harbin, China.'}, {'ForeName': 'Lan', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Department of Critical Care Medicine, The First Affiliated Hospital of Guizhou, University of Traditional Chinese Medicine, Guiyang, China.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Ye', 'Affiliation': 'Department of Critical Care Medicine, Yunnan Provincial hospital of Traditional Chinese Medicine, Kunming, China.'}, {'ForeName': 'Zehuai', 'Initials': 'Z', 'LastName': 'Wen', 'Affiliation': 'Key Unit of Methodology in Clinical Research, The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China.'}, {'ForeName': 'Zhanlin', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Department of Critical Care Medicine, The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China.'}, {'ForeName': 'Minzhou', 'Initials': 'M', 'LastName': 'Zhang', 'Affiliation': 'Department of Critical Care Medicine, The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China.'}, {'ForeName': 'Liheng', 'Initials': 'L', 'LastName': 'Guo', 'Affiliation': 'Department of Critical Care Medicine, The Second Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China.'}]","Shock (Augusta, Ga.)",['10.1097/SHK.0000000000001592'] 2481,32600140,Negative pressure wound therapy versus conventional dressing for open fractures in lower extremity trauma.,"AIMS It has been generally accepted that open fractures require early skeletal stabilization and soft-tissue reconstruction. Traditionally, a standard gauze dressing was applied to open wounds. There has been a recent shift in this paradigm towards negative pressure wound therapy (NPWT). The aim of this study was to compare the clinical outcomes in patients with open tibial fractures receiving standard dressing versus NPWT. METHODS This multicentre randomized controlled trial was approved by the ethical review board of a public sector tertiary care institute. Wounds were graded using Gustilo-Anderson (GA) classification, and patients with GA-II to III-C were included in the study. To be eligible, the patient had to present within 72 hours of the injury. The primary outcome of the study was patient-reported Disability Rating Index (DRI) at 12 months. Secondary outcomes included quality of life assessment using 12-Item Short-Form Health Survey questionnaire (SF-12), wound infection rates at six weeks and nonunion rates at 12 months. Logistic regression analysis and independent-samples t- test were applied for secondary outcomes. Analyses of primary and secondary outcomes were performed using SPSS v. 22.0.1 and p-values of < 0.05 were considered significant. RESULTS A total of 486 patients were randomized between January 2016 and December 2018. Overall 206 (49.04%) patients underwent NPWT, while 214 (50.95%) patients were allocated to the standard dressing group. There was no statistically significant difference in DRI at 12 months between NPWT and standard dressing groups (mean difference 0.5; 95% confidence interval (CI) -0.08 to 1.1; p = 0.581). Regarding SF-12 scores at 12 months follow-up, there was no significant difference at any point from injury until 12 months (mean difference 1.4; 95% CI 0.7 to 1.9; p = 0.781). The 30-day deep infection rate was slightly higher in the standard gauze dressing group. The non-union odds were also comparable (odds ratio (OR) 0.90, 95% CI 0.56 to 1.45; p = 0.685). CONCLUSION Our study concludes that NPWT therapy does not confer benefit over standard dressing technique for open fractures. The DRI, SF-12 scores, wound infection, and nonunion rates were analogous in both study groups. We suggest surgeons continue to use cheaper and more readily available standard dressings. Cite this article: Bone Joint J 2020;102-B(7):912-917.",2020,"Regarding SF-12 scores at 12 months follow-up, there was no significant difference at any point from injury until 12 months (mean difference 1.4; 95% CI 0.7 to 1.9; p = 0.781).","['open fractures in lower extremity trauma', 'patients with open tibial fractures receiving standard dressing versus NPWT', '486 patients were randomized between January 2016 and December 2018', 'patients with GA-II to III-C were included in the study']","['standard gauze dressing', 'Negative pressure wound therapy versus conventional dressing', 'NPWT therapy']","['30-day deep infection rate', 'DRI, SF-12 scores, wound infection, and nonunion rates', 'DRI', 'quality of life assessment using 12-Item Short-Form Health Survey questionnaire (SF-12), wound infection rates at six weeks and nonunion rates', 'patient-reported Disability Rating Index (DRI', 'SF-12 scores']","[{'cui': 'C0016662', 'cui_str': 'Fracture, open'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0040185', 'cui_str': 'Fracture of tibia'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0013119', 'cui_str': 'Medical dressing'}, {'cui': 'C1956078', 'cui_str': 'Topical Negative-Pressure Therapy'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1998495', 'cui_str': 'Gauze dressing'}, {'cui': 'C1956078', 'cui_str': 'Topical Negative-Pressure Therapy'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0013119', 'cui_str': 'Medical dressing'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0043241', 'cui_str': 'Local infection of wound'}, {'cui': 'C0281588', 'cui_str': 'Assessment of quality of life'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0684224', 'cui_str': 'Report'}]",486.0,0.0966509,"Regarding SF-12 scores at 12 months follow-up, there was no significant difference at any point from injury until 12 months (mean difference 1.4; 95% CI 0.7 to 1.9; p = 0.781).","[{'ForeName': 'Muhammad', 'Initials': 'M', 'LastName': 'Tahir', 'Affiliation': 'Department of Orthopaedics, Jinnah Postgraduate Medical Centre, Karachi, Pakistan.'}, {'ForeName': 'Ejaz A', 'Initials': 'EA', 'LastName': 'Chaudhry', 'Affiliation': 'Department of Orthopaedics, Ghurkhi Trust Hospital, Lahore, Pakistan.'}, {'ForeName': 'Faridullah K', 'Initials': 'FK', 'LastName': 'Zimri', 'Affiliation': 'Department of Orthopaedics, National Institute of Rehabilitation Medicine, Islamabad, Pakistan.'}, {'ForeName': 'Nadeem', 'Initials': 'N', 'LastName': 'Ahmed', 'Affiliation': 'Department of Orthopaedics, Jinnah Postgraduate Medical Centre, Karachi, Pakistan.'}, {'ForeName': 'Saeed A', 'Initials': 'SA', 'LastName': 'Shaikh', 'Affiliation': 'Department of Orthopaedics, Jinnah Postgraduate Medical Centre, Karachi, Pakistan.'}, {'ForeName': 'Shoaib', 'Initials': 'S', 'LastName': 'Khan', 'Affiliation': 'Department of Orthopaedics, Whiston Hospital, Prescot, United Kingdom.'}, {'ForeName': 'Usama K', 'Initials': 'UK', 'LastName': 'Choudry', 'Affiliation': 'Shifa International Hopsital, Islamabad, Pakistan.'}, {'ForeName': 'Amer', 'Initials': 'A', 'LastName': 'Aziz', 'Affiliation': 'Department of Orthopaedics, Ghurkhi Trust Hospital, Lahore, Pakistan.'}, {'ForeName': 'Allah R', 'Initials': 'AR', 'LastName': 'Jamali', 'Affiliation': 'Department of Orthopaedics, Jinnah Postgraduate Medical Centre, Karachi, Pakistan.'}]",The bone & joint journal,['10.1302/0301-620X.102B7.BJJ-2019-1462.R1'] 2482,32600149,Operative repair of acute Achilles tendon rupture does not give superior patient-reported outcomes to nonoperative management.,"AIMS The aim was to compare long-term patient-reported outcome measures (PROMs) after operative and nonoperative treatment of acute Achilles tendon rupture in the context of a randomized controlled trial. METHODS PROMs including the Short Musculoskeletal Function Assessment (SMFA), Achilles Tendon Total Rupture Score (ATRS), EuroQol five-dimension (EQ-5D), satisfaction, net promoter score and data regarding re-rupture, and venous thromboembolic rates were collected for patients randomized to receive either operative or nonoperative treatment for acute Achilles tendon rupture in a previous study. Of the 80 patients originally randomized, 64 (33 treated surgically, 31 nonoperatively) patients were followed up at a mean of 15.7 years (13.4 to 17.7). RESULTS There was no statistically significant difference between operatively and nonoperatively treated patients, in SMFA Dysfunction Index (median 1.56 (interquartile range (IQR) 0 to 5.51) vs 1.47 (IQR 0 to 5.15); p = 0.289), SMFA Bother Index (2.08 (IQR 0 to 12.50) vs 0.00 (IQR 0 to 6.25); p = 0.074), ATRS (94 (IQR 86 to 100) vs 95 (IQR 81 to 100); p = 0.313), EQ-5D-5L (1 (IQR 0.75 to 1) vs 1 (IQR 0.84 to 1); p = 0.137) or EQ-5D health today visual analogue score (85 (IQR 72.5 to 95) vs 85 (IQR 8 to 95); p = 0.367). There was no statistically significant difference between operative and nonoperative groups in terms of satisfaction (84% vs 100%; p = 0.119) or willingness to recommend treatment to friends or family (79% vs 87%; p = 0.255). Four nonoperative patients and two in the operative group sustained a re-rupture (p = 0.306). CONCLUSION Both patient groups reported good results at long-term follow-up. The findings give no evidence of superior long-term patient reported outcomes (as measured by the SMFA) for surgical treatment over nonoperative treatment. There was no demonstrable difference in other patient reported outcome measures, satisfaction, or re-rupture rates at long-term follow-up. Cite this article: Bone Joint J 2020;102-B(7):933-940.",2020,There was no statistically significant difference between operative and nonoperative groups in terms of satisfaction (84% vs 100%; p = 0.119) or willingness to recommend treatment to friends or family (79% vs 87%; p = 0.255).,"['80 patients originally randomized, 64 (33 treated surgically, 31 nonoperatively']",['operative or nonoperative treatment'],"['EQ-5D health today visual analogue score', 'SMFA Dysfunction Index', 'SMFA Bother Index', 'satisfaction, or re-rupture rates', 'satisfaction', 're-rupture', 'Short Musculoskeletal Function Assessment (SMFA), Achilles Tendon Total Rupture Score (ATRS), EuroQol five-dimension (EQ-5D), satisfaction, net promoter score and data regarding re-rupture, and venous thromboembolic rates', 'EQ-5D-5L', 'ATRS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0310367', 'cui_str': 'Today'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0026861', 'cui_str': 'Musculoskeletal function'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0443294', 'cui_str': 'Ruptured'}, {'cui': 'C0001074', 'cui_str': 'Structure of Achilles tendon'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C1456447', 'cui_str': 'SLC6A2 protein, human'}, {'cui': 'C0042449', 'cui_str': 'Venous structure'}]",4.0,0.115483,There was no statistically significant difference between operative and nonoperative groups in terms of satisfaction (84% vs 100%; p = 0.119) or willingness to recommend treatment to friends or family (79% vs 87%; p = 0.255).,"[{'ForeName': 'Julian F', 'Initials': 'JF', 'LastName': 'Maempel', 'Affiliation': 'Royal Prince Alfred Hospital, Sydney, Australia.'}, {'ForeName': 'Nicholas D', 'Initials': 'ND', 'LastName': 'Clement', 'Affiliation': 'Royal Infirmary of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Neil R', 'Initials': 'NR', 'LastName': 'Wickramasinghe', 'Affiliation': 'Royal Infirmary of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'Andrew D', 'Initials': 'AD', 'LastName': 'Duckworth', 'Affiliation': 'Royal Infirmary of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'John F', 'Initials': 'JF', 'LastName': 'Keating', 'Affiliation': 'Royal Infirmary of Edinburgh, Edinburgh, UK.'}]",The bone & joint journal,['10.1302/0301-620X.102B7.BJJ-2019-0783.R3'] 2483,32600189,The effect of a structured patient education intervention on the quality of life for coronary artery bypass grafting patients: A prospective randomised controlled study.,"This study aimed to determine the effectiveness of structured patient education on the quality of life for coronary artery bypass grafting patients. The research included 80 patients (40 control, 40 experimental) who underwent coronary artery bypass graft surgery at the cardiovascular surgery ward of a university hospital in Western Turkey and met the criteria to be included in the sample. The following documents were used to collect data: Patient Information Form, Knowledge Level Form and SF36 Quality of Life Scale. It was determined that the structured planned patient education for coronary artery bypass grafting patients effectively improved the patients' knowledge level and quality of life.",2020,It was determined that the structured planned patient education for coronary artery bypass grafting patients effectively improved the patients' knowledge level and quality of life.,"['coronary artery bypass grafting patients', '80 patients (40 control, 40 experimental) who underwent', 'at the cardiovascular surgery ward of a university hospital in Western Turkey and met the criteria to be included in the sample']","['structured patient education', 'coronary artery bypass graft surgery', 'structured patient education intervention']","['quality of life', ""patients' knowledge level and quality of life"", 'Knowledge Level Form and SF36 Quality of Life Scale']","[{'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038897', 'cui_str': 'Cardiovascular surgical procedure'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0041400', 'cui_str': 'Turkey - country'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}]","[{'cui': 'C0030688', 'cui_str': 'Patient education'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0871796', 'cui_str': 'Knowledge level'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0451401', 'cui_str': 'Quality of life scale'}]",80.0,0.0428679,It was determined that the structured planned patient education for coronary artery bypass grafting patients effectively improved the patients' knowledge level and quality of life.,"[{'ForeName': 'Buket', 'Initials': 'B', 'LastName': 'Özdemir', 'Affiliation': 'School of Health, Nursing Division, Department of Surgical Nursing, Tekirdağ Namık Kemal University, Tekirdağ, Turkey.'}, {'ForeName': 'Ebru', 'Initials': 'E', 'LastName': 'Önler', 'Affiliation': 'School of Health, Nursing Division, Department of Surgical Nursing, Tekirdağ Namık Kemal University, Tekirdağ, Turkey.'}]",Journal of perioperative practice,['10.1177/1750458920936915'] 2484,32600260,Promoting routine syphilis screening among men who have sex with men in China: study protocol for a randomised controlled trial of syphilis self-testing and lottery incentive.,"BACKGROUND Men who have sex with men (MSM) bear a high burden of syphilis infection. Expanding syphilis testing to improve timely diagnosis and treatment is critical to improve syphilis control. However, syphilis testing rates remain low among MSM, particularly in low- and middle-income countries. We describe the protocol for a randomised controlled trial (RCT) to assess whether provision of syphilis self-testing services can increase the uptake of syphilis testing among MSM in China. METHODS Four hundred forty-four high-risk MSM will be recruited online and randomized in a 1:1:1 ratio to (1) standard syphilis self-testing arm; (2) a self-testing arm program enhanced with crowdsourcing and a lottery-based incentive, and (3) a standard of care (control). Self-testing services include a free syphilis self-test kit through the mail at monthly intervals. Participants in the lottery incentive arm will additionally receive health promotion materials generated from an open crowdsourcing contest and be given a lottery draw with a 10% chance to win 100 RMB (approximately 15 US Dollars) upon confirmed completion of syphilis testing. Syphilis self-test kits have step-by-step instructions and an instructional video. This is a non-blinded, open-label, parallel RCT. Participants in each arm will be followed-up at three and 6 months through WeChat (a social media app like Facebook messenger). Confirmation of syphilis self-test use will be determined by requiring participants to submit a photo of the used test kit to study staff via secure data messaging. Both self-testing and facility-based testing will be ascertained by sending a secure photographic image of the completed kit through an existing digital platform. The primary outcome is the proportion of participants who tested for syphilis in the past 3 months. DISCUSSION Findings from this study will provide much needed insight on the impact of syphilis self-testing on promoting routine syphilis screening among MSM. The findings will also contribute to our understanding of the safety, effectiveness and acceptability of syphilis self-testing. These findings will have important implications for self-testing policy, both in China and internationally. TRIAL REGISTRATION ChiCTR1900022409 (10 April, 2019).",2020,Participants in each arm will be followed-up at three and 6 months through WeChat (a social media app like Facebook messenger).,"['Four hundred forty-four high-risk MSM will be recruited online and randomized in a 1:1:1 ratio to (1', 'men who have sex with men in China', 'MSM in China', 'Men who have sex with men (MSM']","['lottery incentive arm will additionally receive health promotion materials generated from an open crowdsourcing contest and be given a lottery draw with a 10% chance to win 100 RMB', 'standard syphilis self-testing arm; (2) a self-testing arm program enhanced with crowdsourcing and a lottery-based incentive, and (3) a standard of care (control']",['proportion of participants who tested for syphilis in the past 3 months'],"[{'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C4319568', 'cui_str': '44'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0242657', 'cui_str': 'Men Who Have Sex With Men'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C0021147', 'cui_str': 'Incentives'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0018738', 'cui_str': 'Health promotion'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C3494386', 'cui_str': 'Crowd Sourcing'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0013113', 'cui_str': 'Drawings'}, {'cui': 'C0052080', 'cui_str': 'antineoplaston A10'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0039128', 'cui_str': 'Syphilis'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0039128', 'cui_str': 'Syphilis'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]",444.0,0.0534159,Participants in each arm will be followed-up at three and 6 months through WeChat (a social media app like Facebook messenger).,"[{'ForeName': 'Weibin', 'Initials': 'W', 'LastName': 'Cheng', 'Affiliation': 'Dermatology Hospital of Southern Medical University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Cheng', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'Dermatology Hospital of Southern Medical University, Guangzhou, Guangdong, China. wangcheng090705@gmail.com.'}, {'ForeName': 'Weiming', 'Initials': 'W', 'LastName': 'Tang', 'Affiliation': 'Dermatology Hospital of Southern Medical University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Jason J', 'Initials': 'JJ', 'LastName': 'Ong', 'Affiliation': 'Clinical Research Department, Faculty of Infectious and Tropical Diseases, London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'Hongyun', 'Initials': 'H', 'LastName': 'Fu', 'Affiliation': 'Division of Community Health and Research, Eastern Virginia Medical School, Norfolk, Virginia, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Marks', 'Affiliation': 'Clinical Research Department, Faculty of Infectious and Tropical Diseases, London School of Hygiene and Tropical Medicine, London, UK.'}, {'ForeName': 'M Kumi', 'Initials': 'MK', 'LastName': 'Smith', 'Affiliation': 'Division of Epidemiology and Community Health, University of Minnesota Twin Cities, Minneapolis, USA.'}, {'ForeName': 'Changchang', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'Dermatology Hospital of Southern Medical University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Nie', 'Affiliation': 'Dermatology Hospital of Southern Medical University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Peizhen', 'Initials': 'P', 'LastName': 'Zhao', 'Affiliation': 'Dermatology Hospital of Southern Medical University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Heping', 'Initials': 'H', 'LastName': 'Zheng', 'Affiliation': 'Dermatology Hospital of Southern Medical University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Yang', 'Affiliation': 'Dermatology Hospital of Southern Medical University, Guangzhou, Guangdong, China.'}, {'ForeName': 'Joseph D', 'Initials': 'JD', 'LastName': 'Tucker', 'Affiliation': 'University of North Carolina Project-China, Guangzhou, Guangdong, China.'}]",BMC infectious diseases,['10.1186/s12879-020-05188-z'] 2485,32600295,Cost-effectiveness of immediate versus delayed sequential bilateral cataract surgery in the Netherlands (the BICAT-NL study): study design of a prospective multicenter randomised controlled trial.,"BACKGROUND Cataract surgery is one of the most frequently performed types of surgery. Most patients suffer from bilateral cataract and while cataract surgery of only one eye is effective in restoring functional vision, second-eye surgery leads to further improvements in health-related quality of life, and is cost-effective. At present, most patients undergo cataract surgery in both eyes on separate days as recommended in national guidelines, referred to as delayed sequential bilateral cataract surgery (DSBCS). An alternative procedure involves operating both eyes on the same day, but as separate procedures, known as immediately sequential bilateral cataract surgery (ISBCS). The aim of this study is to evaluate the effectiveness and costs of ISBCS compared to DSBCS, in order to test the hypothesis that ISBCS is non-inferior to DSBCS in terms of effectiveness and superior to ISBCS in terms of cost-effectiveness. METHODS/DESIGN Multicenter non-inferiority randomised controlled clinical trial. Patients (18 years or older) with bilateral cataract and an indication for bilateral cataract surgery with an expected uncomplicated intraoperative and postoperative course are included in the study. Patients are randomly assigned to either ISBCS or DSBCS. The primary endpoint is the proportion of patients with a refractive outcome in the second eye within 1.0 dioptre from the target refraction, at 4 weeks after surgery. Secondary outcomes include corrected and uncorrected distance visual acuity, complications, patient reported outcomes (PROMs), cost-effectiveness, and budget impact. Follow-up visits are planned at 1 week after first-eye surgery and 4 weeks after second-eye surgery. At 3 months after first-eye surgery, the occurrence of complications is checked and patients fill in a final questionnaire. DISCUSSION This study protocol describes the design of a multicenter non-inferiority randomised controlled trial. Current studies on ISBCS often lack information on safety regarding refractive outcomes. In addition, there is a lack of well-designed cost-effectiveness studies using established methods. The BICAT-NL study will provide more insight in refractive and cost-effectiveness outcomes for ISBCS compared to DSBCS. TRIAL REGISTRATION This study was prospectively registered at Clinicaltrials.gov on January 17th 2018. (Identifier: NCT03400124 .",2020,Patients (18 years or older) with bilateral cataract and an indication for bilateral cataract surgery with an expected uncomplicated intraoperative and postoperative course are included in the study.,"['January 17th 2018', 'Patients (18\u2009years or older) with bilateral cataract and an indication for bilateral cataract surgery with an expected uncomplicated intraoperative and postoperative course are included in the study']","['ISBCS', 'immediate versus delayed sequential bilateral cataract surgery', 'ISBCS or DSBCS', 'DSBCS']","['corrected and uncorrected distance visual acuity, complications, patient reported outcomes (PROMs), cost-effectiveness, and budget impact', 'Cost-effectiveness', 'proportion of patients with a refractive outcome', 'occurrence of complications']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0521707', 'cui_str': 'Bilateral cataracts'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0443334', 'cui_str': 'Uncomplicated'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0205548', 'cui_str': 'Stat'}, {'cui': 'C0521707', 'cui_str': 'Bilateral cataracts'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}]","[{'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0429537', 'cui_str': 'Distance visual acuity'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0006347', 'cui_str': 'Budgets'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}]",,0.221822,Patients (18 years or older) with bilateral cataract and an indication for bilateral cataract surgery with an expected uncomplicated intraoperative and postoperative course are included in the study.,"[{'ForeName': 'L S', 'Initials': 'LS', 'LastName': 'Spekreijse', 'Affiliation': 'Maastricht University Medical Center+, University Eye Clinic Maastricht, P. Debyelaan 25, 6229 HX, Maastricht, the Netherlands. lindsay.spekreijse@mumc.nl.'}, {'ForeName': 'R W P', 'Initials': 'RWP', 'LastName': 'Simons', 'Affiliation': 'Maastricht University Medical Center+, University Eye Clinic Maastricht, P. Debyelaan 25, 6229 HX, Maastricht, the Netherlands.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Winkens', 'Affiliation': 'Department of Methodology and Statistics, Faculty of Health, Medicine and Life Sciences (FHML), Care and Public Health Research Institute (CAPHRI), Maastricht University, Maastricht, the Netherlands.'}, {'ForeName': 'F J H M', 'Initials': 'FJHM', 'LastName': 'van den Biggelaar', 'Affiliation': 'Maastricht University Medical Center+, University Eye Clinic Maastricht, P. Debyelaan 25, 6229 HX, Maastricht, the Netherlands.'}, {'ForeName': 'C D', 'Initials': 'CD', 'LastName': 'Dirksen', 'Affiliation': 'Department of Clinical Epidemiology and Medical Technology Assessment, CAPHRI School for Public Health and Primary Care, Maastricht University Medical Center+, Maastricht, the Netherlands.'}, {'ForeName': 'R M M A', 'Initials': 'RMMA', 'LastName': 'Nuijts', 'Affiliation': 'Maastricht University Medical Center+, University Eye Clinic Maastricht, P. Debyelaan 25, 6229 HX, Maastricht, the Netherlands.'}]",BMC ophthalmology,['10.1186/s12886-020-01521-x'] 2486,32600320,"Evaluation of breath, plasma, and urinary markers of lactose malabsorption to diagnose lactase non-persistence following lactose or milk ingestion.","BACKGROUND Adult lactase non-persistence (LNP) is due to low lactase expression, resulting in lactose malabsorption (LM). LNP is a genetic trait, but is typically determined by LM markers including breath H 2 , blood glucose, and urinary galactose after a lactose tolerance test. Known validity of these markers using milk is limited, despite being common practice. Compositional variation, such as β-casein variants, in milk may impact diagnostic efficacy. This study aimed to evaluate the diagnostic accuracy to detect LNP using these commonly measured LM markers after both lactose and milk challenges. METHODS Fourty healthy young women were challenged with 50 g lactose then randomized for separate cross-over visits to ingest 750 mL milk (37.5 g lactose) as conventional (both A1 and A2 β-casein) and A1 β-casein-free (a2 Milk™) milk. Blood, breath and urine were collected prior to and up to 3 h following each challenge. The presence of C/T 13910 and G/A 22018 polymorphisms, determined by restriction fragment length polymorphism, was used as the diagnostic reference for LNP. RESULTS Genetic testing identified 14 out of 40 subjects as having LNP (C/C 13910 and G/G 22018 ). All three LM markers (breath H 2 , plasma glucose and urinary galactose/creatinine) discriminated between lactase persistence (LP) and LNP following lactose challenge with an area under the receiver operating characteristic (ROC) curve (AUC) of 1.00, 0.75 and 0.73, respectively. Plasma glucose and urinary galactose/creatinine were unreliable (AUC < 0.70) after milk ingestion. The specificity of breath H 2 remained high (100%) when milk was used, but sensitivity was reduced with conventional (92.9%) and a2 Milk™ (78.6%) compared to lactose (sensitivities adjusted for lactose content). The breath H 2 optimal cut-off value was lower with a2 Milk™ (13 ppm) than conventional milk (21 ppm). Using existing literature cut-off values the sensitivity and specificity of breath H 2 was greater than plasma glucose to detect LNP following lactose challenge whereas values obtained for urinary galactose/creatinine were lower than the existing literature cut-offs. CONCLUSION This study showed accurate diagnosis of LNP by breath H 2 irrespective of the substrate used, although the diagnostic threshold may vary depending on the lactose substrate or the composition of the milk. TRIAL REGISTRATION ACTRN12616001694404 . Registered prospectively on December 9, 2016.",2020,"The specificity of breath H 2 remained high (100%) when milk was used, but sensitivity was reduced with conventional (92.9%) and a2 Milk™ (78.6%) compared to lactose (sensitivities adjusted for lactose content).",['Fourty healthy young women'],"['lactose or milk ingestion', '50\u2009g lactose then randomized for separate cross-over visits to ingest 750\u2009mL milk (37.5\u2009g lactose) as conventional (both A1 and A2 β-casein) and A1 β-casein-free (a2 Milk™) milk', 'LNP']","['specificity of breath H 2 remained high', 'Blood, breath and urine', 'Plasma glucose and urinary galactose/creatinine', 'breath H 2 , blood glucose, and urinary galactose', 'LM markers (breath H 2 , plasma glucose and urinary galactose/creatinine']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0022949', 'cui_str': 'Lactose'}, {'cui': 'C0026131', 'cui_str': 'Milk'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0443299', 'cui_str': 'Separate'}, {'cui': 'C0010366', 'cui_str': 'Genetic crossing over'}, {'cui': 'C4517868', 'cui_str': '750'}, {'cui': 'C4517742', 'cui_str': '37.5'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0007332', 'cui_str': 'Caseins'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0005220', 'cui_str': 'Beta-galactosidase'}, {'cui': 'C0546816', 'cui_str': 'Persistence'}]","[{'cui': 'C0037791', 'cui_str': 'Specificity'}, {'cui': 'C0225386', 'cui_str': 'Breath'}, {'cui': 'C0011744', 'cui_str': 'Deuterium'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma'}, {'cui': 'C0016945', 'cui_str': 'Galactose'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0022951', 'cui_str': 'Intolerance to lactose'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}]",,0.0263172,"The specificity of breath H 2 remained high (100%) when milk was used, but sensitivity was reduced with conventional (92.9%) and a2 Milk™ (78.6%) compared to lactose (sensitivities adjusted for lactose content).","[{'ForeName': 'Aahana', 'Initials': 'A', 'LastName': 'Shrestha', 'Affiliation': 'The Liggins Institute, The University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Matthew P G', 'Initials': 'MPG', 'LastName': 'Barnett', 'Affiliation': 'The Riddet Institute, Palmerston North, New Zealand.'}, {'ForeName': 'Jo K', 'Initials': 'JK', 'LastName': 'Perry', 'Affiliation': 'The Liggins Institute, The University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Cameron-Smith', 'Affiliation': 'The Liggins Institute, The University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'Amber M', 'Initials': 'AM', 'LastName': 'Milan', 'Affiliation': 'The Liggins Institute, The University of Auckland, Auckland, New Zealand. a.milan@auckland.ac.nz.'}]",BMC gastroenterology,['10.1186/s12876-020-01352-6'] 2487,32600363,"Impact of pantoprazole on absorption and disposition of hydroxychloroquine, a drug used in Corona Virus Disease-19 (Covid-19): A structured summary of a study protocol for a randomised controlled trial.","OBJECTIVES Primary objective: Evaluation of the effect of the proton pump inhibitor (PPI) pantoprazole on the absorption of hydroxychloroquine (HCQ). Secondary objectives: • Evaluation of the relationship between HCQ concentrations in whole blood, plasma and intracellular concentrations in target cells - peripheral blood mononuclear cells (PBMCs). • Evaluation of HCQ as a potential perpetrator in drug-drug interactions at the level of cytochrome P450 (CYP) 3A4 and CYP2D6 (major drug metabolizing enzymes). TRIAL DESIGN Single centre, open-label, parallel group, two-arm, phase I drug-drug interaction trial. PARTICIPANTS Healthy volunteers (18-60 years old) are treated in the Clinical Pharmacological Trial Center of Heidelberg University Hospital, Germany. INTERVENTION AND COMPARATOR • Participants are randomized in a group to either receive a nine-day course of pantoprazole, or to a control group without pantoprazole. All participants receive a single dose of HCQ 400 mg. • Additionally, CYP3A4 and CYP2D6 phenotyping with microdosed probe drugs is performed using midazolam and yohimbine as enzyme activity markers, respectively. MAIN OUTCOMES Primary endpoint: Area under the curve (AUC) 0-72 h and maximum concentration (C max ) of a single oral dose of 400 mg HCQ with and without pantoprazole (changes in these two values describe relevant aspects of exposure to HCQ with and without administration of pantoprazole). Secondary endpoints: • AUC 2-4 h , AUC 0-6 h and C max of midazolam and yohimbine. • Correlation of HCQ concentrations in whole blood with concentrations in plasma and peripheral blood mononuclear cells (PBMC). RANDOMISATION Participants are assigned to treatment groups by using a randomisation list (1:1, block size = 4) and consecutive enrolment. BLINDING (MASKING) The trial is an open-label trial, participants and investigators are not blinded. NUMBERS TO BE RANDOMISED (SAMPLE SIZE) A total number of 24 participants (12 per group) are planned to be randomised. TRIAL STATUS Protocol version 2.1 dated 24/04/2020, first patient first visit. April 30th, 2020, recruitment ongoing, anticipated end of study June 30th, 2020. TRIAL REGISTRATION EudraCT Number: 2020-001470-30 , registered on 31 March 2020 German Clinical trials register number / International Clinical Trials Registry Platform: DRKS00021573, registered on 27 April 2020 FULL PROTOCOL: The full trial protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full trial protocol. The trial protocol has been reported in accordance with the Standard Protocol Items: Recommendations for Clinical Interventional Trials (SPIRIT) guidelines (Additional file 2).",2020,"Evaluation of HCQ as a potential perpetrator in drug-drug interactions at the level of cytochrome P450 (CYP) 3A4 and CYP2D6 (major drug metabolizing enzymes). ","['2020-001470-30 , registered on 31 March 2020 German Clinical trials register number / International Clinical Trials Registry Platform', 'Healthy volunteers (18-60 years old) are treated in the Clinical Pharmacological Trial Center of Heidelberg University Hospital, Germany', 'Corona Virus Disease-19 (Covid-19', 'registered on 27 April 2020']","['pantoprazole', 'hydroxychloroquine', 'pantoprazole, or to a control group without pantoprazole', 'HCQ', 'midazolam and yohimbine', 'proton pump inhibitor (PPI) pantoprazole']","['plasma and peripheral blood mononuclear cells (PBMC', 'Primary endpoint: Area under the curve (AUC) 0-72 h and maximum concentration (C max ', 'HCQ concentrations in whole blood, plasma and intracellular concentrations in target cells - peripheral blood mononuclear cells (PBMCs', 'absorption of hydroxychloroquine (HCQ']","[{'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0017477', 'cui_str': 'German language'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0034975', 'cui_str': 'Registries'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0031330', 'cui_str': 'Pharmacology'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0042769', 'cui_str': 'Viral disease'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]","[{'cui': 'C0081876', 'cui_str': 'pantoprazole'}, {'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0026056', 'cui_str': 'Midazolam'}, {'cui': 'C0724441', 'cui_str': 'yohimbine'}, {'cui': 'C0358591', 'cui_str': 'H+/K+-exchanging ATPase inhibitor'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C1321301', 'cui_str': 'Peripheral blood mononuclear cell'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood'}, {'cui': 'C0175996', 'cui_str': 'Protoplasm'}, {'cui': 'C0221284', 'cui_str': 'Leptocyte'}, {'cui': 'C0237442', 'cui_str': 'Physiological Absorption'}]",,0.443929,"Evaluation of HCQ as a potential perpetrator in drug-drug interactions at the level of cytochrome P450 (CYP) 3A4 and CYP2D6 (major drug metabolizing enzymes). ","[{'ForeName': 'Felicitas', 'Initials': 'F', 'LastName': 'Stoll', 'Affiliation': 'Heidelberg University Hospital, Heidelberg, Baden-Württemberg, Germany.'}, {'ForeName': 'Antje', 'Initials': 'A', 'LastName': 'Blank', 'Affiliation': 'Heidelberg University Hospital, Heidelberg, Baden-Württemberg, Germany. antje.blank@med.uni-heidelberg.de.'}, {'ForeName': 'Gerd', 'Initials': 'G', 'LastName': 'Mikus', 'Affiliation': 'Heidelberg University Hospital, Heidelberg, Baden-Württemberg, Germany.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Czock', 'Affiliation': 'Heidelberg University Hospital, Heidelberg, Baden-Württemberg, Germany.'}, {'ForeName': 'Kathrin I', 'Initials': 'KI', 'LastName': 'Foerster', 'Affiliation': 'Heidelberg University Hospital, Heidelberg, Baden-Württemberg, Germany.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Hermann', 'Affiliation': 'Heidelberg University Hospital, Heidelberg, Baden-Württemberg, Germany.'}, {'ForeName': 'Katja', 'Initials': 'K', 'LastName': 'Häußler', 'Affiliation': 'Heidelberg University Hospital, Heidelberg, Baden-Württemberg, Germany.'}, {'ForeName': 'Amin', 'Initials': 'A', 'LastName': 'Muhareb', 'Affiliation': 'Heidelberg University Hospital, Heidelberg, Baden-Württemberg, Germany.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Hummler', 'Affiliation': 'Heidelberg University Hospital, Heidelberg, Baden-Württemberg, Germany.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Weiss', 'Affiliation': 'Heidelberg University Hospital, Heidelberg, Baden-Württemberg, Germany.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Burhenne', 'Affiliation': 'Heidelberg University Hospital, Heidelberg, Baden-Württemberg, Germany.'}, {'ForeName': 'Walter E', 'Initials': 'WE', 'LastName': 'Haefeli', 'Affiliation': 'Heidelberg University Hospital, Heidelberg, Baden-Württemberg, Germany.'}]",Trials,['10.1186/s13063-020-04476-y'] 2488,32600378,"Therapeutic pulmonary telerehabilitation protocol for patients affected by COVID-19, confined to their homes: study protocol for a randomized controlled trial.","BACKGROUND In December 2019, 27 cases of pneumonia, of unknown cause, were identified in the province of Hubei (China). The WHO declared the situation as a Public Health Emergency of International Concern, and it was finally declared a global pandemic on March 11, 2020. The Spanish Government obliges the entire population to remain confined to their homes, with the exception of essential basic services, to stop the spread of COVID-19. Home isolation implies a notable physical deconditioning. Telerehabilitation methods have reported positive experiences, and we propose to study in affected patients of COVID-19, due to the general house confinement of the entire Spanish population. METHODS Patients will be recruited in the regions of Andalusia, Murcia, and Valencia (Spain). Patients will remain confined to their homes, and there, they will carry out their assigned exercise program, which will be controlled telematically. Evaluators will attend to carry out all measurements at the beginning, during, and end of the study, telematically controlled. The patients will be randomly divided into three groups, two of them will perform a home exercise program (breathing exercises or non-specific exercises for muscle toning) and the third group will perform sedentary activities, using mental activation techniques, and will act as a sham group. We will evaluate respiratory variables and other variables of the physical state through physical tests, effort, and perceived fatigue. The data will be statistically analyzed, and the hypotheses will be tested between the groups, using the SPSS software, v.24, considering a 95% confidence interval. DISCUSSION We will analyze the results, in terms of the level of fatigue and perceived exertion, physical health, and maintenance of respiratory activity of two types of exercise programs, toning and respiratory, applied in patients affected by COVID-19 during the period of home confinement. We intend to investigate a field not previously studied, such as the repercussion of carrying out a toning and respiratory exercise program in these patients, in historical circumstances that no one had previously observed in Spain, since the general population has never been forced to remain confined in their homes, due to a pandemic infection, by a coronavirus (COVID-19). Observing the effects that these two home exercise programs could produce in patients infected with COVID-19, we will try to better analyze and understand the mechanisms that are associated with the worsening of breathing in this type of patient. TRIAL REGISTRATION Brazilian Clinical Trial Registry RBR-6m69fc . Registered on March 31, 2020.",2020,"We will analyze the results, in terms of the level of fatigue and perceived exertion, physical health, and maintenance of respiratory activity of two types of exercise programs, toning and respiratory, applied in patients affected by COVID-19 during the period of home confinement.","['patients affected by COVID-19 during the period of home confinement', 'Patients will be recruited in the regions of Andalusia, Murcia, and Valencia (Spain', 'patients affected by COVID-19, confined to their homes', 'In December 2019, 27 cases of pneumonia, of unknown cause, were identified in the province of Hubei (China']","['home exercise program (breathing exercises or non-specific exercises for muscle toning) and the third group will perform sedentary activities, using mental activation techniques, and will act as a sham group', 'Therapeutic pulmonary telerehabilitation protocol']",[],"[{'cui': 'C0522476', 'cui_str': 'Patient affected'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C0205396', 'cui_str': 'Identified'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C0475647', 'cui_str': 'Home exercise program'}, {'cui': 'C0006155', 'cui_str': 'Physiotherapeutic breathing exercise'}, {'cui': 'C0205370', 'cui_str': 'Non-specific'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0026841', 'cui_str': 'Muscle Tension'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0205254', 'cui_str': 'Inactive'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0449263', 'cui_str': 'Activation technique'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C4042802', 'cui_str': 'Remote Rehabilitation'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}]",[],,0.0649068,"We will analyze the results, in terms of the level of fatigue and perceived exertion, physical health, and maintenance of respiratory activity of two types of exercise programs, toning and respiratory, applied in patients affected by COVID-19 during the period of home confinement.","[{'ForeName': 'Juan Jose', 'Initials': 'JJ', 'LastName': 'Gonzalez-Gerez', 'Affiliation': 'Fisiosur I+D Research Institute, Garrucha, Almería, Spain.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'Bernal-Utrera', 'Affiliation': 'Fisiosur I+D Research Institute, Garrucha, Almería, Spain. cbernal495@gmail.com.'}, {'ForeName': 'Ernesto', 'Initials': 'E', 'LastName': 'Anarte-Lazo', 'Affiliation': 'Centre of Precision Rehabilitation for Spinal Pain (CPR Spine), School of Sport, Exercise and Rehabilitation Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Jose Antonio', 'Initials': 'JA', 'LastName': 'Garcia-Vidal', 'Affiliation': 'Physiotherapy Department, University of Murcia, Murcia, Spain.'}, {'ForeName': 'Jose Martin', 'Initials': 'JM', 'LastName': 'Botella-Rico', 'Affiliation': 'Physiotherapy Department, University Cardenal Herrera-CEU, Elche, Alicante, Spain.'}, {'ForeName': 'Cleofas', 'Initials': 'C', 'LastName': 'Rodriguez-Blanco', 'Affiliation': 'Fisiosur I+D Research Institute, Garrucha, Almería, Spain.'}]",Trials,['10.1186/s13063-020-04494-w'] 2489,32600386,"The effectiveness of radial extracorporeal shock wave therapy (rESWT), sham-rESWT, standardised exercise programme or usual care for patients with plantar fasciopathy: study protocol for a double-blind, randomised, sham-controlled trial.","BACKGROUND Plantar fasciopathy is a common cause of plantar heel pain, with a reported prevalence of up to 10%. The choice of best practice in these patients is debated. Two randomised studies reported that radial extracorporeal shock wave therapy is effective, but a meta-analysis concluded that due to methodological limitations, the evidence is questionable. There are few studies reporting the effect of exercise programs with high-load strength training, despite widespread use. The objective of this placebo-controlled, observer-blinded and partly patient blinded trial is to compare rESWT, sham-rESWT, standardised exercise programme and usual care for alleviating heel pain at 6 and 12 months follow-up. METHODS/DESIGN A double-blind, randomised, sham-controlled trial is conducted at a hospital outpatient clinic of physical medicine and rehabilitation. Patients with chronic (> 3 months) pain due to plantar fasciopathy, aged 18 to 70 years old, are eligible for inclusion in the trial. Patients will be randomly allocated in 1:1 ratio to receive rESWT, sham-rESWT, standardised exercises or usual care. The sample size is estimated to 200 patients, 50 in each group. rESWT or sham-rESWT will be given once a week for 3 weeks. A physiotherapist will supervise the exercises, with a total of 8 sessions over 12 weeks. The patients in the usual care group will receive information, advice and foot orthosis only. All patients, regardless of group, will receive the same information and get an individual customised foot orthosis made by an orthopaedic technician. The primary outcome measure is heel pain intensity during activity in the last week, using a numeric rating scale (NRS, 0 to 10) at the 6 months follow-up adjusted for baseline pain intensity. The secondary outcomes are at the 6- and 12-month follow-up and include Foot Functional Index Revised Short Version (FFI-RS), Patient Global Impression of Change Scale (7-point Likert scale), RAND-12 Health Status Inventory (RAND-12), NRS during rest and NRS during activity (12 months). The patients receiving rESWT/sham-rESWT and the outcome assessor will be blinded to the group assignment. DISCUSSION This trial is designed in order to provide results important for future clinical practice. TRIAL REGISTRATION ClinicalTrials.gov NCT03472989 . Registered on 14 March 2018.",2020,"All patients, regardless of group, will receive the same information and get an individual customised foot orthosis made by an orthopaedic technician.","['hospital outpatient clinic of physical medicine and rehabilitation', 'patients with plantar fasciopathy', 'Patients with chronic (>\u20093\u2009months) pain due to plantar fasciopathy, aged 18 to 70\u2009years old, are eligible for inclusion in the trial', '200 patients, 50 in each group']","['radial extracorporeal shock wave therapy', 'rESWT, sham-rESWT, standardised exercise programme and usual care', 'rESWT, sham-rESWT, standardised exercises or usual care', 'rESWT or sham-rESWT', 'radial extracorporeal shock wave therapy (rESWT), sham-rESWT, standardised exercise programme or usual care', 'rESWT/sham-rESWT', 'placebo']","['heel pain', '6- and 12-month follow-up and include Foot Functional Index Revised Short Version (FFI-RS), Patient Global Impression of Change Scale (7-point Likert scale), RAND-12 Health Status Inventory (RAND-12), NRS during rest and NRS during activity (12\u2009months', 'heel pain intensity during activity in the last week, using a numeric rating scale (NRS, 0 to 10']","[{'cui': 'C0029916', 'cui_str': 'Hospital Outpatient Clinics'}, {'cui': 'C0031813', 'cui_str': 'Physical Medicine and Rehabilitation'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0230463', 'cui_str': 'Structure of sole of foot'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0442038', 'cui_str': 'Radial'}, {'cui': 'C1737238', 'cui_str': 'Extracorporeal shock wave therapy'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0231780', 'cui_str': 'Heel pain'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0206042', 'cui_str': 'Fatal familial insomnia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0451267', 'cui_str': 'Likert scale'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0237753', 'cui_str': 'Number'}]",,0.549098,"All patients, regardless of group, will receive the same information and get an individual customised foot orthosis made by an orthopaedic technician.","[{'ForeName': 'Marte', 'Initials': 'M', 'LastName': 'Heide', 'Affiliation': 'Faculty of Medicine, University of Oslo, Postboks 1078, Blindern, Oslo, Norway. marte.heide@medisin.uio.no.'}, {'ForeName': 'Marianne', 'Initials': 'M', 'LastName': 'Mørk', 'Affiliation': 'Faculty of Medicine, University of Oslo, Postboks 1078, Blindern, Oslo, Norway.'}, {'ForeName': 'Cecilie', 'Initials': 'C', 'LastName': 'Røe', 'Affiliation': 'Faculty of Medicine, University of Oslo, Postboks 1078, Blindern, Oslo, Norway.'}, {'ForeName': 'Jens Ivar', 'Initials': 'JI', 'LastName': 'Brox', 'Affiliation': 'Faculty of Medicine, University of Oslo, Postboks 1078, Blindern, Oslo, Norway.'}, {'ForeName': 'Aasne', 'Initials': 'A', 'LastName': 'Fenne Hoksrud', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Oslo University Hospital, Postboks 4956, Ullevål, Nydalen, 0242, Oslo, Norway.'}]",Trials,['10.1186/s13063-020-04510-z'] 2490,31679079,Platelet aggregation is not altered among men with diabetes mellitus.,"AIMS Platelets are pivotal in arterial thrombosis, and platelet hyperresponsiveness may contribute to the increased incidence of cardiovascular events in diabetes mellitus. Consequently, we hypothesized that increased in vitro platelet aggregation responses exist in men with diabetes mellitus. METHODS The Danish Cardiovascular Screening Trial (DANCAVAS) is a community-based cardiovascular screening trial including men aged 65-74 years. Platelet aggregation was tested using 96-well light transmission aggregometry with thrombin receptor-activating peptide (TRAP), adenosine diphosphate, collagen type 1, arachidonic acid and protease-activated receptor-4 in three concentrations. Further, cardiovascular risk factors and coronary artery calcification (CAC), estimated by CT scans and ankle-brachial index, were obtained. RESULTS Included were 720 men aged 65-74 years, 110 with diabetes mellitus. Overall, there was no difference in platelet aggregation among men with versus without diabetes mellitus when adjusting for or excluding platelet inhibitor treatment and men with established cardiovascular disease (CVD). This was true for all agonists, e.g., 10 µM TRAP-induced platelet aggregation of median 69% (IQR 53-75) versus 70% (IQR 60-76) in men with versus without diabetes mellitus. Platelet aggregation did not correlate with HbA 1c or CAC. Men with diabetes mellitus displayed higher CAC, median 257 Agatston units (IQR 74-1141) versus median 111 Agatston units (IQR 6-420) in the remaining individuals, p < 0.0001. CONCLUSIONS Among outpatients with diabetes mellitus, but no CVD and no platelet inhibitor treatment, neither are platelets hyperresponsive in diabetes mellitus, nor is platelet aggregation associated with glycemic status or with the degree of coronary atherosclerosis. TRIAL REGISTRATION ISRCTN12157806.",2020,"Overall, there was no difference in platelet aggregation among men with versus without diabetes mellitus when adjusting for or excluding platelet inhibitor treatment and men with established cardiovascular disease (CVD).","['Men with diabetes mellitus', 'outpatients with diabetes mellitus', 'men with diabetes mellitus', 'men aged 65-74\xa0years', 'diabetes mellitus', '720 men aged 65-74\xa0years, 110 with diabetes mellitus']",[],"['cardiovascular risk factors and coronary artery calcification (CAC), estimated by CT scans and ankle-brachial index', 'Platelet aggregation', 'platelet aggregation']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517865', 'cui_str': '720'}, {'cui': 'C4517536', 'cui_str': '110'}]",[],"[{'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C1611184', 'cui_str': 'Calcification of coronary artery'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C1328319', 'cui_str': 'Ankle brachial pressure index'}, {'cui': 'C0032176', 'cui_str': 'Platelet aggregation'}]",720.0,0.0437632,"Overall, there was no difference in platelet aggregation among men with versus without diabetes mellitus when adjusting for or excluding platelet inhibitor treatment and men with established cardiovascular disease (CVD).","[{'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Kring', 'Affiliation': 'Department of Clinical Biochemistry and Pharmacology, Odense University Hospital, Sdr. Boulevard 29, 5000, Odense C, Denmark. christiankringnygaard@gmail.com.'}, {'ForeName': 'Lars M', 'Initials': 'LM', 'LastName': 'Rasmussen', 'Affiliation': 'Department of Clinical Biochemistry and Pharmacology, Odense University Hospital, Sdr. Boulevard 29, 5000, Odense C, Denmark.'}, {'ForeName': 'Jes S', 'Initials': 'JS', 'LastName': 'Lindholt', 'Affiliation': 'Centre of Individualized Medicine in Arterial Disease (CIMA), Odense, Denmark.'}, {'ForeName': 'Axel C P', 'Initials': 'ACP', 'LastName': 'Diederichsen', 'Affiliation': 'Centre of Individualized Medicine in Arterial Disease (CIMA), Odense, Denmark.'}, {'ForeName': 'Pernille J', 'Initials': 'PJ', 'LastName': 'Vinholt', 'Affiliation': 'Department of Clinical Biochemistry and Pharmacology, Odense University Hospital, Sdr. Boulevard 29, 5000, Odense C, Denmark.'}]",Acta diabetologica,['10.1007/s00592-019-01438-y'] 2491,32608055,Can radiographic patellofemoral osteoarthritis be diagnosed using clinical assessments?,"INTRODUCTION The aim of this study was to determine whether participant characteristics and clinical assessments could identify radiographic osteoarthritis (OA) in individuals with clinically diagnosed, symptomatic patellofemoral osteoarthritis (PFOA). METHODS Participant characteristics and clinical assessments were obtained from 179 individuals aged 50 years and over with clinically diagnosed symptomatic PFOA, who were enrolled in a randomised trial. Anteroposterior, lateral, and skyline X-rays were taken of the symptomatic knee. The presence of radiographic PFOA was defined as ""no or early PFOA"" (Kellgren and Lawrence [KL] grade ≤1 in the PF compartment) or ""definite PFOA"" (KL grade ≥2). Diagnostic test statistics were applied to ascertain which participant characteristics and clinical assessments could identify the presence of definite radiographic PFOA. RESULTS A total of 118 participants (66%) had definite radiographic PFOA. Univariate analysis identified that older age (>61 years), female sex, higher body mass index (BMI) (>29 kg/m 2 ), longer pain duration (>2.75 years), higher maximum knee pain during stair ambulation (>47/100 mm), and fewer repeated single step-ups to pain onset (<21) were associated with the presence of definite radiographic PFOA. Multivariate logistic regression indicated that BMI, pain duration, and repeated single step-ups to pain onset were independently associated with radiographic PFOA and identified the presence of definite radiographic PFOA with an overall accuracy of 73%. CONCLUSION In individuals over 50 years of age with a clinical diagnosis of PFOA, higher BMI, longer pain duration, and fewer repeated single step-ups to pain onset increased the likelihood of radiographic PFOA. However, overall diagnostic accuracy was modest, suggesting that radiographic PFOA cannot be confidently identified using these tests.",2020,"Multivariate logistic regression indicated that BMI, pain duration, and repeated single step-ups to pain onset were independently associated with radiographic PFOA and identified the presence of definite radiographic PFOA with an overall accuracy of 73%. ","['older age (>61 years), female sex, higher body mass index (BMI) (>29 kg/m 2 ), longer pain duration (>2.75 years), higher maximum knee pain during stair ambulation (>47/100 mm), and fewer repeated single step-ups to pain onset (<21', '118 participants (66%) had definite radiographic PFOA', '179 individuals aged 50 years and over with clinically diagnosed symptomatic PFOA, who were enrolled in a randomised trial', 'individuals with clinically diagnosed, symptomatic patellofemoral osteoarthritis (PFOA']",[],"['BMI, pain duration, and repeated single step-ups to pain onset', 'radiographic osteoarthritis (OA', 'overall diagnostic accuracy', 'radiographic PFOA']","[{'cui': 'C0231337', 'cui_str': 'Senility'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086287', 'cui_str': 'Female'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C4517639', 'cui_str': '2.75'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0231749', 'cui_str': 'Knee pain'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0205388', 'cui_str': 'Few'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0454366', 'cui_str': 'Step ups'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C4517542', 'cui_str': '118'}, {'cui': 'C0439544', 'cui_str': 'Definite'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C1542808', 'cui_str': 'Patellofemoral osteoarthritis'}, {'cui': 'C4517609', 'cui_str': '179'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]",[],"[{'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0454366', 'cui_str': 'Step ups'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C1542808', 'cui_str': 'Patellofemoral osteoarthritis'}]",118.0,0.0692962,"Multivariate logistic regression indicated that BMI, pain duration, and repeated single step-ups to pain onset were independently associated with radiographic PFOA and identified the presence of definite radiographic PFOA with an overall accuracy of 73%. ","[{'ForeName': 'Jade M', 'Initials': 'JM', 'LastName': 'Tan', 'Affiliation': 'Discipline of Podiatry, School of Allied Health, Human Services and Sport, La Trobe University, Melbourne, Australia.'}, {'ForeName': 'Hylton B', 'Initials': 'HB', 'LastName': 'Menz', 'Affiliation': 'Discipline of Podiatry, School of Allied Health, Human Services and Sport, La Trobe University, Melbourne, Australia.'}, {'ForeName': 'Shannon E', 'Initials': 'SE', 'LastName': 'Munteanu', 'Affiliation': 'Discipline of Podiatry, School of Allied Health, Human Services and Sport, La Trobe University, Melbourne, Australia.'}, {'ForeName': 'Natalie J', 'Initials': 'NJ', 'LastName': 'Collins', 'Affiliation': 'La Trobe Sport and Exercise Medicine Research Centre, School of Allied Health, Human Services and Sport, La Trobe University, Melbourne, Australia.'}, {'ForeName': 'Harvi F', 'Initials': 'HF', 'LastName': 'Hart', 'Affiliation': 'La Trobe Sport and Exercise Medicine Research Centre, School of Allied Health, Human Services and Sport, La Trobe University, Melbourne, Australia.'}, {'ForeName': 'Joel W', 'Initials': 'JW', 'LastName': 'Donnar', 'Affiliation': 'La Trobe Sport and Exercise Medicine Research Centre, School of Allied Health, Human Services and Sport, La Trobe University, Melbourne, Australia.'}, {'ForeName': 'Gearoid', 'Initials': 'G', 'LastName': 'Cleary', 'Affiliation': 'School of Health and Rehabilitation Sciences, The University of Queensland, Brisbane, Australia.'}, {'ForeName': 'Isobel C', 'Initials': 'IC', 'LastName': ""O'Sullivan"", 'Affiliation': 'School of Health and Rehabilitation Sciences, The University of Queensland, Brisbane, Australia.'}, {'ForeName': 'Liam R', 'Initials': 'LR', 'LastName': 'Maclachlan', 'Affiliation': 'School of Health and Rehabilitation Sciences, The University of Queensland, Brisbane, Australia.'}, {'ForeName': 'Catherine L', 'Initials': 'CL', 'LastName': 'Derham', 'Affiliation': 'La Trobe Sport and Exercise Medicine Research Centre, School of Allied Health, Human Services and Sport, La Trobe University, Melbourne, Australia.'}, {'ForeName': 'Kay M', 'Initials': 'KM', 'LastName': 'Crossley', 'Affiliation': 'La Trobe Sport and Exercise Medicine Research Centre, School of Allied Health, Human Services and Sport, La Trobe University, Melbourne, Australia.'}]",Musculoskeletal care,['10.1002/msc.1490'] 2492,32608096,A randomised clinical pilot trial to test the effectiveness of parent training with video modelling to improve functioning and symptoms in children with autism spectrum disorders and intellectual disability.,"BACKGROUND Poor eye contact and joint attention are early signs of autism spectrum disorder (ASD) and important prerequisites for developing other socio-communicative skills. Teaching parents evidence-based techniques to improve these skills can impact the overall functioning of children with ASD. We aimed to analyse the impact of conducting a group parent-training intervention with video modelling to improve the intelligent quotient (IQ), social and communication functioning and to minimise symptoms in children with ASD and intellectual disability (ID). METHODS Study design: A multicentre, single-blinded, randomised clinical pilot trial of parent training using video modelling was conducted. SAMPLE Sixty-seven parents of children with ASD, aged between 3 and 6 years and with IQs between 50 and 70, were randomised: 34 to the intervention group and 33 to the control group. Intervention program: The intervention group received parent training over 22 sessions, and the control group received the standard community treatment. INSTRUMENTS Pre-evaluation and post-evaluation (week 28), the following were used: Autism Diagnostic Interview, Vineland Adaptive Behaviour Scale I, Snijders-Oomen Nonverbal Intelligence Test, Autism Behaviour Checklist and Hamilton Depression Rating Scale. DATA ANALYSIS Intention to treat and complier-average causal effect (CACE) were used to estimate the effects of the intervention. RESULTS There was a statistically significant improvement in the Vineland standardized communication scores in CACE (Cohen's d = 0.260). There was a non-statistically significant decrease in autism symptomatology (Autism Behaviour Checklist total scores) and a significant increase in the non-verbal IQ in the intervention group. After the false discovery rate correction was applied, IQ remained statistically significant under both paradigms. The effect size for this adjusted outcome under the intention-to-treat paradigm was close to 0.4, and when considering adherence (CACE), the effect sizes were more robust (IQ's Cohen's d = 0.433). CONCLUSIONS Parent training delivered by video modelling can be a useful technique for improving the care given to children with ASD and ID, particularly in countries that lack specialists.",2020,There was a non-statistically significant decrease in autism symptomatology (Autism Behaviour Checklist total scores) and a significant increase in the non-verbal IQ in the intervention group.,"['children with ASD', 'children with ASD and intellectual disability (ID', 'SAMPLE\n\n\nSixty-seven parents of children with ASD, aged between 3 and 6\xa0years and with IQs between 50 and 70, were randomised: 34 to the intervention group and 33 to the control group', 'children with autism spectrum disorders and intellectual disability']","['Intervention program', 'parent training with video modelling', 'parent training over 22 sessions, and the control group received the standard community treatment']","['Vineland standardized communication scores', 'I, Snijders-Oomen Nonverbal Intelligence Test, Autism Behaviour Checklist and Hamilton Depression Rating Scale', 'non-verbal IQ', 'functioning and symptoms', 'Autism Diagnostic Interview, Vineland Adaptive', 'autism symptomatology (Autism Behaviour Checklist total scores', 'Behaviour Scale', 'intelligent quotient (IQ), social and communication functioning']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0524528', 'cui_str': 'Autism spectrum disorder'}, {'cui': 'C3714756', 'cui_str': 'Intellectual disability'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C4517852', 'cui_str': '67'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0021705', 'cui_str': 'Intelligence test'}, {'cui': 'C0004352', 'cui_str': 'Autistic disorder'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0021822', 'cui_str': 'Interviews as Topic'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",,0.0700665,There was a non-statistically significant decrease in autism symptomatology (Autism Behaviour Checklist total scores) and a significant increase in the non-verbal IQ in the intervention group.,"[{'ForeName': 'D', 'Initials': 'D', 'LastName': 'Bordini', 'Affiliation': 'Social Cognition Clinic - TEAMM, Department of Psychiatry, Universidade Federal de São Paulo (UNIFESP), Sao Paulo, Brazil.'}, {'ForeName': 'C S', 'Initials': 'CS', 'LastName': 'Paula', 'Affiliation': 'Social Cognition Clinic - TEAMM, Department of Psychiatry, Universidade Federal de São Paulo (UNIFESP), Sao Paulo, Brazil.'}, {'ForeName': 'G R', 'Initials': 'GR', 'LastName': 'Cunha', 'Affiliation': 'Social Cognition Clinic - TEAMM, Department of Psychiatry, Universidade Federal de São Paulo (UNIFESP), Sao Paulo, Brazil.'}, {'ForeName': 'S C', 'Initials': 'SC', 'LastName': 'Caetano', 'Affiliation': 'Department of Psychiatry, Universidade Federal de São Paulo (UNIFESP), Sao Paulo, Brazil.'}, {'ForeName': 'L F', 'Initials': 'LF', 'LastName': 'Bagaiolo', 'Affiliation': 'Social Cognition Clinic - TEAMM, Department of Psychiatry, Universidade Federal de São Paulo (UNIFESP), Sao Paulo, Brazil.'}, {'ForeName': 'T C', 'Initials': 'TC', 'LastName': 'Ribeiro', 'Affiliation': 'Institute of Psychiatry, University of São Paulo Medical School, Sao Paulo, Brazil.'}, {'ForeName': 'M C C', 'Initials': 'MCC', 'LastName': 'Martone', 'Affiliation': 'Department of Psychology - LAHMEI, Universidade Federal de São Carlos (UFSCar), Sao Carlos, Brazil.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Portolese', 'Affiliation': 'Institute of Psychiatry, University of São Paulo Medical School, Sao Paulo, Brazil.'}, {'ForeName': 'A C', 'Initials': 'AC', 'LastName': 'Moya', 'Affiliation': 'Social Cognition Clinic - TEAMM, Department of Psychiatry, Universidade Federal de São Paulo (UNIFESP), Sao Paulo, Brazil.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Brunoni', 'Affiliation': 'Development Disorders Program, Universidade Presbiteriana Mackenzie, Sao Paulo, Brazil.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Bosa', 'Affiliation': 'Department of Psychology, Universidade Federal do Rio Grande do Sul, Porto Alegre, Brazil.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Brentani', 'Affiliation': 'Institute of Psychiatry, University of São Paulo Medical School, Sao Paulo, Brazil.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Cogo-Moreira', 'Affiliation': 'Department of Psychiatry, Universidade Federal de São Paulo (UNIFESP), Sao Paulo, Brazil.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'de Jesus Mari', 'Affiliation': 'Social Cognition Clinic - TEAMM, Department of Psychiatry, Universidade Federal de São Paulo (UNIFESP), Sao Paulo, Brazil.'}]",Journal of intellectual disability research : JIDR,['10.1111/jir.12759'] 2493,32608120,Effect of recorded maternal voice on emergence agitation in children undergoing bilateral ophthalmic surgery: A randomised controlled trial.,"AIM This study was designed to investigate whether the playing-back of the recorded maternal voice through the headphones to children undergoing bilateral ophthalmic surgery has clinical effects on the incidence of emergence agitation, and the anaesthesia recovery course. METHODS In this prospective, blinded and randomised study, 127 children, aged 2-8 years and undergoing bilateral ophthalmic surgery were randomly allocated to one of the two groups: group T (treatment group, listening to recorded mother's voice via headphones) or group C (control group, wearing headphones without auditory stimuli). The primary outcome was the incidence of emergence agitation, and the secondary outcomes were the awakening time, and the post-anaesthesia care unit (PACU) stay time. RESULTS Children in the group of listening recorded mother's voice exhibited significantly low incidence of emergence agitation compared with those in the control group (32.8 vs. 55.6%; odds ratio (95% confidence interval): 0.39(0.19-0.80); P = 0.010). The awakening time was shorter in group T as compared to that in group C (22.9 (10.4) vs. 27.3 (13.7); P = 0.048). As results, the group T had significantly less PACU stay time with early discharge than the group C did (29.7 (12.1) vs. 34.8 (14.1); P = 0.031). CONCLUSIONS Recorded mother's voice is an efficient method to reduce emergence agitation in children undergoing bilateral ophthalmic surgery with sevoflurane anaesthesia. Also, patients were waking up faster and PACU stay time was shorter in mother's voice group as compared with the control group.",2020,The awakening time was shorter in group T as compared to that in group C (22.9 (10.4) vs. 27.3 (13.7); P = 0.048).,"['children undergoing bilateral ophthalmic surgery', '127 children, aged 2-8\u2009years and undergoing bilateral ophthalmic surgery', 'children undergoing bilateral ophthalmic surgery with sevoflurane anaesthesia']","[""group T (treatment group, listening to recorded mother's voice via headphones) or group C (control group, wearing headphones without auditory stimuli"", 'recorded maternal voice']","['awakening time, and the post-anaesthesia care unit (PACU) stay time', 'emergence agitation', 'awakening time', 'PACU stay time with early discharge', 'PACU stay time', 'incidence of emergence agitation']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C1705869', 'cui_str': 'Ophthalmic surgery'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}]","[{'cui': 'C0036669', 'cui_str': 'Group T'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0004309', 'cui_str': 'Auditory Perception'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0042939', 'cui_str': 'Voice'}, {'cui': 'C0441067', 'cui_str': 'Earphones'}, {'cui': 'C0441837', 'cui_str': 'Group C'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0178490', 'cui_str': 'Auditory stimulus'}]","[{'cui': 'C1720052', 'cui_str': 'Awakening'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0920253', 'cui_str': 'Agitated Emergence'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}]",127.0,0.285404,The awakening time was shorter in group T as compared to that in group C (22.9 (10.4) vs. 27.3 (13.7); P = 0.048).,"[{'ForeName': 'Yan-Yan', 'Initials': 'YY', 'LastName': 'Yang', 'Affiliation': ""Department of Anaesthesiology, Shanghai Children's Medical Centre, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.""}, {'ForeName': 'Ma-Zhong', 'Initials': 'MZ', 'LastName': 'Zhang', 'Affiliation': ""Department of Anaesthesiology, Shanghai Children's Medical Centre, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.""}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': ""Department of Anaesthesiology, Shanghai Children's Medical Centre, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.""}, {'ForeName': 'Zhe-Zhe', 'Initials': 'ZZ', 'LastName': 'Peng', 'Affiliation': ""Department of Anaesthesiology, Shanghai Children's Medical Centre, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.""}, {'ForeName': 'Pei-Pei', 'Initials': 'PP', 'LastName': 'Liu', 'Affiliation': ""Department of Anaesthesiology, Shanghai Children's Medical Centre, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.""}, {'ForeName': 'Yan-Ting', 'Initials': 'YT', 'LastName': 'Wang', 'Affiliation': ""Department of Anaesthesiology, Shanghai Children's Medical Centre, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.""}, {'ForeName': 'Ji-Jian', 'Initials': 'JJ', 'LastName': 'Zheng', 'Affiliation': ""Department of Anaesthesiology, Shanghai Children's Medical Centre, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.""}, {'ForeName': 'Jun-Zheng', 'Initials': 'JZ', 'LastName': 'Wu', 'Affiliation': ""Department of Anaesthesia and Paediatrics, Cincinnati Children's Hospital Medical Centre, Cincinnati, Ohio, United States.""}]",Journal of paediatrics and child health,['10.1111/jpc.14948'] 2494,32608131,Interactive mental health assessments for Chinese Canadians: A pilot randomized controlled trial in nurse practitioner-led primary care clinic.,"INTRODUCTION Mental health conditions like depression and anxiety are on the rise, but access to care remains a challenge. Immigrants and racialized communities including Chinese Canadians experience high level of access barriers including communication with clinicians. With the aim to facilitate mental health communications, we tested an Interactive Computer-assisted Client Assessment Survey (iCCAS) in Cantonese/Mandarin and English at a nurse practitioner-led primary care clinic in Toronto. The iCCAS offers a touch-screen, pre-consultation survey with questions on depression, anxiety, post-traumatic stress, alcohol abuse, and social context. The program generates point-of-care reports for the clinician and patient. METHODS A pilot randomized controlled trial examined the intervention impact on mental health discussion and symptom detection, compared with the usual care, followed by clinicians' qualitative interviews. RESULTS Fifty self-identified Chinese adult patients participated (iCCAS = 26, Usual Care = 24), response rate 79.4%. Participant mean age was 44.8 years and 92% were immigrants. There was an increase of 19% and 15% in the mental health discussion and detection of symptoms in the iCCAS group compared with the usual care. More participants in the iCCAS group were referred to a social worker or psychiatrist. Patients found the use of iCCAS easy and clinicians identified its benefits for themselves (eg, early identification and comfort) and patients (eg, self-awareness and anonymity) and proposed practice-integration. DISCUSSION The studied tool holds promise for enhancing clinician-patient mental health communications in primary care settings for overseas Chinese. Implications are discussed for in-person and virtual healthcare which could also inform responses to mental health crisis related to COVID-19.",2020,There was an increase of 19% and 15% in the mental health discussion and detection of symptoms in the iCCAS group compared with the usual care.,"['nurse practitioner-led primary care clinic', 'Participant mean age was 44.8\u2009years and 92% were immigrants', 'More participants in the iCCAS group were referred to a social worker or psychiatrist', 'Chinese Canadians', 'Cantonese/Mandarin and English at a nurse practitioner-led primary care clinic in Toronto']","['iCCAS', 'Interactive Computer-assisted Client Assessment Survey (iCCAS']","['mental health discussion and detection of symptoms', 'Interactive mental health assessments']","[{'cui': 'C0028657', 'cui_str': 'Nurse practitioner'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C1552443', 'cui_str': 'Primary care clinic'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0282163', 'cui_str': 'Immigrant'}, {'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0008942', 'cui_str': 'Clients'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0037444', 'cui_str': 'Social worker'}, {'cui': 'C0033872', 'cui_str': 'Psychiatrist'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C0376245', 'cui_str': 'English language'}]","[{'cui': 'C0009622', 'cui_str': 'Computer'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0008942', 'cui_str': 'Clients'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}]","[{'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0557061', 'cui_str': 'Discussion'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C2720502', 'cui_str': 'Mental health assessment'}]",,0.0413923,There was an increase of 19% and 15% in the mental health discussion and detection of symptoms in the iCCAS group compared with the usual care.,"[{'ForeName': 'Farah', 'Initials': 'F', 'LastName': 'Ahmad', 'Affiliation': 'School of Health Policy and Management, York University, Toronto, Ontario, Canada.'}, {'ForeName': 'Jamie', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Office of Research and Innovations, North York General Hospital, Toronto, Ontario, Canada.'}, {'ForeName': 'Bonnie', 'Initials': 'B', 'LastName': 'Wong', 'Affiliation': 'Hong Fook Mental Health Association, Toronto, Ontario, Canada.'}, {'ForeName': 'Wai Lun Alan', 'Initials': 'WLA', 'LastName': 'Fung', 'Affiliation': 'HF Connecting Health Nurse Practitioner-Led Clinic, Toronto, Ontario, Canada.'}]",Asia-Pacific psychiatry : official journal of the Pacific Rim College of Psychiatrists,['10.1111/appy.12400'] 2495,32609011,Renin and Survival in Patients Given Angiotensin II for Catecholamine-Resistant Vasodilatory Shock.,"RATIONALE Exogenous angiotensin II increases mean arterial pressure in patients with catecholamine-resistant vasodilatory shock (CRVS). We hypothesized that renin levels may identify patients most likely to benefit from such therapy. OBJECTIVES To test the kinetic changes in renin levels and their prognostic value in CRVS patients. METHODS We analyzed serum samples from patients enrolled in the Angiotensin II for the Treatment of High-Output Shock (ATHOS-3) trial for renin, angiotensin I, and angiotensin II levels prior to the start of administration of angiotensin II or placebo and after 3 hours. MEASUREMENTS AND MAIN RESULTS Baseline serum renin concentration (normal range: 2.13-58.78 pg/ml) was above the upper limits of normal (ULN) in 194/255 (76%) study patients with a median renin concentration of 172.7 pg/mL (interquartile range [IQR]: 60.7-440.6 pg/mL), approximately three-fold higher than ULN. Renin levels correlated positively with angiotensin I/angiotensin II ratios (r =.39; P<0.001). At 3 hours after initiation of angiotensin II therapy, there was a 54.3% reduction (IQR: 37.9%-66.5% reduction) in renin concentration compared with a 14.1% reduction (IQR: 37.6% reduction to 5.1% increase) with placebo (P<0.0001). In patients with renin concentrations above the study population median, angiotensin II significantly reduced 28-day mortality to 28/55 (50.9%) patients compared with 51/73 patients (69.9%) treated with placebo (unstratified hazard ratio: 0.56; 95% confidence interval: 0.35-0.88; P=0.012) (p = 0.048 for the interaction). CONCLUSIONS Serum renin concentration is markedly elevated in CRVS and may identify patients for whom treatment with angiotensin II has a beneficial effect on clinical outcomes. This article is open access and distributed under the terms of the Creative Commons Attribution Non-Commercial No Derivatives License 4.0 (http://creativecommons.org/licenses/by-nc-nd/4.0/).",2020,Renin levels correlated positively with angiotensin I/angiotensin II ratios (r =.39; P<0.001).,"['CRVS patients', 'patients with catecholamine-resistant vasodilatory shock (CRVS', 'Patients Given Angiotensin II for Catecholamine-Resistant Vasodilatory Shock', 'patients enrolled in the Angiotensin II for the Treatment of High-Output Shock (ATHOS-3) trial for renin, angiotensin I, and angiotensin II levels prior to the start of administration of']","['placebo', 'angiotensin', 'angiotensin II therapy', 'angiotensin II or placebo']","['renin levels', 'Renin and Survival', 'Renin levels', 'renin concentration', 'Baseline serum renin concentration', '28-day mortality', 'mean arterial pressure', 'median renin concentration', 'Serum renin concentration']","[{'cui': 'C0007412', 'cui_str': 'Catecholamine'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0036974', 'cui_str': 'Shock'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0003009', 'cui_str': 'angiotensin II'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C3251815', 'cui_str': 'Measurement of fluid output'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0035094', 'cui_str': 'Renin'}, {'cui': 'C0003006', 'cui_str': 'Angiotensin I'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0439659', 'cui_str': 'Origins'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0003018', 'cui_str': 'Angiotensin'}, {'cui': 'C0003009', 'cui_str': 'angiotensin II'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0035094', 'cui_str': 'Renin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",,0.111806,Renin levels correlated positively with angiotensin I/angiotensin II ratios (r =.39; P<0.001).,"[{'ForeName': 'Rinaldo', 'Initials': 'R', 'LastName': 'Bellomo', 'Affiliation': 'The University of Melbourne, 2281, Centre for Integrated Critical Care, Department of Medicine & Radiology, Melbourne, Victoria, Australia.'}, {'ForeName': 'Lui G', 'Initials': 'LG', 'LastName': 'Forni', 'Affiliation': 'Royal Surrey County Hospital NHS Foundation Trust and Faculty of Health Sciences University of Surrey, Department of Intensive Care Medicine, Guildford, United Kingdom of Great Britain and Northern Ireland.'}, {'ForeName': 'Laurence W', 'Initials': 'LW', 'LastName': 'Busse', 'Affiliation': 'Emory University, 1371, Department of Medicine, Division of Pulmonary, Allergy, Critical Care and Sleep Medicine, Atlanta, Georgia, United States.'}, {'ForeName': 'Michael T', 'Initials': 'MT', 'LastName': 'McCurdy', 'Affiliation': 'University of Maryland School of Medicine, 12264, Pulmonary and Critical Care, Baltimore, Maryland, United States.'}, {'ForeName': 'Kealy R', 'Initials': 'KR', 'LastName': 'Ham', 'Affiliation': 'University of Minnesota System, 311816, Pulmonary, Allergy, Critical Care and Sleep Medicine, Minneapolis, Minnesota, United States.'}, {'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Boldt', 'Affiliation': 'University of California Los Angeles, 8783, Department of Anesthesiology and Perioperative Medicine, Division of Critical Care, Los Angeles, California, United States.'}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Hästbacka', 'Affiliation': 'University of Helsinki and Helsinki University Hospital, Division of Intensive Care Medicine, Department of Perioperative, Intensive Care and Pain Medicine, Helsinki, Finland.'}, {'ForeName': 'Ashish K', 'Initials': 'AK', 'LastName': 'Khanna', 'Affiliation': 'Wake Forest University School of Medicine, 12279, Department of Anesthesiology, Section on Critical Care Medicine, Winston-Salem, North Carolina, United States.'}, {'ForeName': 'Timothy E', 'Initials': 'TE', 'LastName': 'Albertson', 'Affiliation': 'University of California, Northern California Health System, Department of Internal Medicine, Division of Pulmonary, Critical Care and Sleep Medicine, School of Medicine, Mather, California, United States.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Tumlin', 'Affiliation': 'Emory University Medical Center, Department of Medicine, Renal Division, Atlanta, Georgia, United States.'}, {'ForeName': 'Kristine', 'Initials': 'K', 'LastName': 'Storey', 'Affiliation': 'La Jolla Pharmaceutical Company, 17726, Department of Bioanalytics, San Diego, California, United States.'}, {'ForeName': 'Damian', 'Initials': 'D', 'LastName': 'Handisides', 'Affiliation': 'La Jolla Pharmaceutical Company, 17726, Department of Biostatistics, San Diego, California, United States.'}, {'ForeName': 'George F', 'Initials': 'GF', 'LastName': 'Tidmarsh', 'Affiliation': 'La Jolla Pharmaceutical Company, 17726, Chief Executive Officer, San Diego, California, United States.'}, {'ForeName': 'Lakhmir S', 'Initials': 'LS', 'LastName': 'Chawla', 'Affiliation': 'La Jolla Pharmaceutical Company, 17726, Chief Medical Officer, San Diego, California, United States.'}, {'ForeName': 'Marlies', 'Initials': 'M', 'LastName': 'Ostermann', 'Affiliation': ""King's College London, Guy's & St Thomas Hospital, Critical Care, London, United Kingdom of Great Britain and Northern Ireland.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American journal of respiratory and critical care medicine,['10.1164/rccm.201911-2172OC'] 2496,32609018,Erratum: Pitolisant for Daytime Sleepiness in Patients with Obstructive Sleep Apnea Who Refuse Continuous Positive Airway Pressure Treatment. A Randomized Trial.,,2020,,['Patients with Obstructive Sleep Apnea'],[],['Daytime Sleepiness'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}]",[],"[{'cui': 'C0541854', 'cui_str': 'Daytime sleepiness'}]",,0.0148899,,[],American journal of respiratory and critical care medicine,['10.1164/rccm.v202erratum1'] 2497,32609036,Evaluation of a Novel Educational Intervention to Improve Conversations About Implantable Cardioverter-Defibrillators Management in Patients with Advanced Heart Failure.,"Background: Implantable cardioverter-defibrillators (ICDs) reduce the incidence of sudden cardiac death for high-risk patients with heart failure (HF), but shocks from these devices can also cause pain and anxiety at the end of life. Although professional society recommendations encourage proactive discussions about ICD deactivation, clinicians lack training in conducting these conversations, and they occur infrequently. Methods: As part of a six-center randomized controlled trial, we evaluated the educational component of a multicomponent intervention shown to increase conversations about ICD deactivation by clinicians who care for a subset of patients with advanced HF. This consisted of a 90-minute training workshop designed to improve the quality and frequency of conversations about ICD management. To characterize its utility as an isolated intervention, we compared HF clinicians' pre- and postworkshop scores (on a 5-point Likert scale) assessing self-reported confidence and skills in specific practices of advance care planning, ICD deactivation discussions, and empathic communication. Results: Forty intervention-group HF clinicians completed both pre- and postworkshop surveys. Preworkshop scores showed high baseline levels of confidence (4.36, standard deviation [SD] = 0.70) and skill (4.08, SD = 0.72), whereas comparisons of pre- and postworkshop scores showed nonsignificant decreases in confidence (-1.16, p  = 0.252) and skill (-0.20, p  = 0.843) after the training session. Conclusions: Our findings showed no significant changes in self-assessment ratings immediately after the educational intervention. However, our data did demonstrate that HF clinicians had high baseline self-perceptions of their skills in advance care planning conversations and appear to be well-primed for further professional development to improve communication in the setting of advanced HF.",2020,Our findings showed no significant changes in self-assessment ratings immediately after the educational intervention.,"['patients with advanced HF', 'Patients with Advanced Heart Failure', 'high-risk patients with heart failure (HF']","['Implantable cardioverter-defibrillators (ICDs', 'Novel Educational Intervention', 'multicomponent intervention']","['self-assessment ratings', 'sudden cardiac death']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}]","[{'cui': 'C0162589', 'cui_str': 'Implantable defibrillator'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0036591', 'cui_str': 'Self Assessment'}, {'cui': 'C0085298', 'cui_str': 'Sudden cardiac death'}]",,0.0354669,Our findings showed no significant changes in self-assessment ratings immediately after the educational intervention.,"[{'ForeName': 'Ian B', 'Initials': 'IB', 'LastName': 'Kwok', 'Affiliation': 'Department of Internal Medicine, Icahn School of Medicine at Mount Sinai, Mount Sinai Beth Israel Hospital, New York, New York, USA.'}, {'ForeName': 'Harriet', 'Initials': 'H', 'LastName': 'Mather', 'Affiliation': 'Brookdale Department of Geriatrics and Palliative Medicine, Icahn School of Medicine at Mount Sinai, New York, New York, USA.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'McKendrick', 'Affiliation': 'Brookdale Department of Geriatrics and Palliative Medicine, Icahn School of Medicine at Mount Sinai, New York, New York, USA.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Gelfman', 'Affiliation': 'Brookdale Department of Geriatrics and Palliative Medicine, Icahn School of Medicine at Mount Sinai, New York, New York, USA.'}, {'ForeName': 'Mathew D', 'Initials': 'MD', 'LastName': 'Hutchinson', 'Affiliation': 'Division of Cardiovascular Medicine, Sarver Heart Center, University of Arizona College of Medicine Tucson, Tucson, Arizona, USA.'}, {'ForeName': 'Rachel J', 'Initials': 'RJ', 'LastName': 'Lampert', 'Affiliation': 'Department of Internal Medicine, Section of Cardiology, Yale University School of Medicine, New Haven, Connecticut, USA.'}, {'ForeName': 'Hannah I', 'Initials': 'HI', 'LastName': 'Lipman', 'Affiliation': 'Department of Internal Medicine, Hackensack Meridian School of Medicine at Seton Hall University, Nutley, New Jersey, USA.'}, {'ForeName': 'Daniel D', 'Initials': 'DD', 'LastName': 'Matlock', 'Affiliation': 'Division of General Internal Medicine, Department of Medicine, University of Colorado School of Medicine, Aurora, Colorado, USA.'}, {'ForeName': 'Keith M', 'Initials': 'KM', 'LastName': 'Swetz', 'Affiliation': 'Birmingham Veterans Affairs Medical Center, Department of Medicine and UAB Center for Palliative and Supportive Care, University of Alabama Birmingham, Birmingham, Alabama, USA.'}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Kalman', 'Affiliation': 'Lenox Hill Hospital, Northwell Health, New York, New York, USA.'}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'Pinney', 'Affiliation': 'Division of Cardiology, Samuel Bronfman Department of Medicine, Icahn School of Medicine at Mount Sinai, New York, New York, USA.'}, {'ForeName': 'R Sean', 'Initials': 'RS', 'LastName': 'Morrison', 'Affiliation': 'Brookdale Department of Geriatrics and Palliative Medicine, Icahn School of Medicine at Mount Sinai, New York, New York, USA.'}, {'ForeName': 'Nathan E', 'Initials': 'NE', 'LastName': 'Goldstein', 'Affiliation': 'Brookdale Department of Geriatrics and Palliative Medicine, Icahn School of Medicine at Mount Sinai, New York, New York, USA.'}]",Journal of palliative medicine,['10.1089/jpm.2020.0022'] 2498,32609069,Comparison of two forced-air warming device during foot and ankle surgery: A randomised controlled trial.,"Inadvertent perioperative hypothermia is a frequent problem associated with surgical patients which can have significant consequences during surgery and in the immediate postoperative period. We compared 35 randomised patients using over vs. under body forced air heating. There were no statistically significant differences between some demographic and surgical parameters such as: age, weight, height, body mass index, length of anaesthesia and operation. Statistically significant differences were found between the patient's admission to the operating room and 30 minutes and the end of the procedure on the under body patients group. This study analyses a uniform population of patients (Foot and Ankle Surgery) previously not studied and supports the use of under body blankets.",2020,"There were no statistically significant differences between some demographic and surgical parameters such as: age, weight, height, body mass index, length of anaesthesia and operation.","['35 randomised patients using over vs. under body forced air heating', 'during foot and ankle surgery']",['two forced-air warming device'],"['age, weight, height, body mass index, length of anaesthesia and operation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0018851', 'cui_str': 'Heating'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0188412', 'cui_str': 'Operative procedure on ankle'}]","[{'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005890', 'cui_str': 'Body height measure'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]",35.0,0.0509046,"There were no statistically significant differences between some demographic and surgical parameters such as: age, weight, height, body mass index, length of anaesthesia and operation.","[{'ForeName': 'Jorge Javier Del', 'Initials': 'JJD', 'LastName': 'Vecchio', 'Affiliation': 'Head Foot and Ankle Section, Orthopaedics Department, Hospital Universitario - Fundación Favaloro, Ciudad Autónoma de Buenos Aires (CABA), Argentina.'}, {'ForeName': 'Lucas Nicolás', 'Initials': 'LN', 'LastName': 'Chemes', 'Affiliation': 'Department of Kinesiology and Physiatry, Universidad Favaloro, Buenos Aires, Argentina.'}, {'ForeName': 'Mauricio Esteban', 'Initials': 'ME', 'LastName': 'Ghioldi', 'Affiliation': 'Department of Kinesiology and Physiatry, Universidad Favaloro, Buenos Aires, Argentina.'}, {'ForeName': 'Eric Daniel', 'Initials': 'ED', 'LastName': 'Dealbera', 'Affiliation': 'Foot and Ankle Section, Fundación Favaloro - Hospital Universitario, Buenos Aires, Argentina.'}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Daniel Morgillo', 'Affiliation': 'Foot and Ankle Surgery and Limb Salvage Fellowship, Foot and Ankle Section, Fundación Favaloro - Hospital Universitario, Buenos Aires, Argentina.'}]",Journal of perioperative practice,['10.1177/1750458920927286'] 2499,32609084,Progesterone to prevent miscarriage in women with early pregnancy bleeding: the PRISM RCT.,"BACKGROUND Progesterone is essential for a healthy pregnancy. Several small trials have suggested that progesterone therapy may rescue a pregnancy in women with early pregnancy bleeding, which is a symptom that is strongly associated with miscarriage. OBJECTIVES (1) To assess the effects of vaginal micronised progesterone in women with vaginal bleeding in the first 12 weeks of pregnancy. (2) To evaluate the cost-effectiveness of progesterone in women with early pregnancy bleeding. DESIGN A multicentre, double-blind, placebo-controlled, randomised trial of progesterone in women with early pregnancy vaginal bleeding. SETTING A total of 48 hospitals in the UK. PARTICIPANTS Women aged 16-39 years with early pregnancy bleeding. INTERVENTIONS Women aged 16-39 years were randomly assigned to receive twice-daily vaginal suppositories containing either 400 mg of progesterone or a matched placebo from presentation to 16 weeks of gestation. MAIN OUTCOME MEASURES The primary outcome was live birth at ≥ 34 weeks. In addition, a within-trial cost-effectiveness analysis was conducted from an NHS and NHS/Personal Social Services perspective. RESULTS A total of 4153 women from 48 hospitals in the UK received either progesterone ( n  = 2079) or placebo ( n  = 2074). The follow-up rate for the primary outcome was 97.2% (4038 out of 4153 participants). The live birth rate was 75% (1513 out of 2025 participants) in the progesterone group and 72% (1459 out of 2013 participants) in the placebo group (relative rate 1.03, 95% confidence interval 1.00 to 1.07; p  = 0.08). A significant subgroup effect (interaction test p  = 0.007) was identified for prespecified subgroups by the number of previous miscarriages: none (74% in the progesterone group vs. 75% in the placebo group; relative rate 0.99, 95% confidence interval 0.95 to 1.04; p  = 0.72); one or two (76% in the progesterone group vs. 72% in the placebo group; relative rate 1.05, 95% confidence interval 1.00 to 1.12; p  = 0.07); and three or more (72% in the progesterone group vs. 57% in the placebo group; relative rate 1.28, 95% confidence interval 1.08 to 1.51; p  = 0.004). A significant post hoc subgroup effect (interaction test p  = 0.01) was identified in the subgroup of participants with early pregnancy bleeding and any number of previous miscarriage(s) (75% in the progesterone group vs. 70% in the placebo group; relative rate 1.09, 95% confidence interval 1.03 to 1.15; p  = 0.003). There were no significant differences in the rate of adverse events between the groups. The results of the health economics analysis show that progesterone was more costly than placebo (£7655 vs. £7572), with a mean cost difference of £83 (adjusted mean difference £76, 95% confidence interval -£559 to £711) between the two arms. Thus, the incremental cost-effectiveness ratio of progesterone compared with placebo was estimated as £3305 per additional live birth at ≥ 34 weeks of gestation. CONCLUSIONS Progesterone therapy in the first trimester of pregnancy did not result in a significantly higher rate of live births among women with threatened miscarriage overall, but an important subgroup effect was identified. A conclusion on the cost-effectiveness of the PRISM trial would depend on the amount that society is willing to pay to increase the chances of an additional live birth at ≥ 34 weeks. For future work, we plan to conduct an individual participant data meta-analysis using all existing data sets. TRIAL REGISTRATION Current Controlled Trials ISRCTN14163439, EudraCT 2014-002348-42 and Integrated Research Application System (IRAS) 158326. FUNDING This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment ; Vol. 24, No. 33. See the NIHR Journals Library website for further project information.",2020,"The results of the health economics analysis show that progesterone was more costly than placebo (£7655 vs. £7572), with a mean cost difference of £83 (adjusted mean difference £76, 95% confidence interval -£559 to £711) between the two arms.","['women with early pregnancy bleeding', 'women with early pregnancy vaginal bleeding', 'Women aged 16-39 years', '4153 women from 48 hospitals in the UK received either', 'A total of 48 hospitals in the UK', 'women with vaginal bleeding in the first 12 weeks of pregnancy', 'Women aged 16-39 years with early pregnancy bleeding']","['twice-daily vaginal suppositories containing either 400\u2009mg of progesterone or a matched placebo', 'progesterone', 'progesterone therapy', 'vaginal micronised progesterone', 'Progesterone therapy', 'Progesterone', 'placebo']","['rate of live births', 'rate of adverse events', 'incremental cost-effectiveness ratio of progesterone', 'early pregnancy bleeding and any number of previous miscarriage(s', 'live birth at ≥\u200934 weeks', 'live birth rate', 'cost-effectiveness']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0156604', 'cui_str': 'Haemorrhage in early pregnancy, unspecified'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C2979982', 'cui_str': 'Vaginal bleeding'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0439230', 'cui_str': 'week'}]","[{'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C1136199', 'cui_str': 'Vaginal pessary'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0033308', 'cui_str': 'Progesterone'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0279495', 'cui_str': 'Progestogen hormone therapy'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}]","[{'cui': 'C0481667', 'cui_str': 'Live birth'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0033308', 'cui_str': 'Progesterone'}, {'cui': 'C0156604', 'cui_str': 'Haemorrhage in early pregnancy, unspecified'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0439230', 'cui_str': 'week'}]",4153.0,0.68774,"The results of the health economics analysis show that progesterone was more costly than placebo (£7655 vs. £7572), with a mean cost difference of £83 (adjusted mean difference £76, 95% confidence interval -£559 to £711) between the two arms.","[{'ForeName': 'Arri', 'Initials': 'A', 'LastName': 'Coomarasamy', 'Affiliation': 'Institute of Metabolism and Systems Research, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Hoda M', 'Initials': 'HM', 'LastName': 'Harb', 'Affiliation': 'Institute of Metabolism and Systems Research, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Adam J', 'Initials': 'AJ', 'LastName': 'Devall', 'Affiliation': 'Institute of Metabolism and Systems Research, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Versha', 'Initials': 'V', 'LastName': 'Cheed', 'Affiliation': 'Institute of Applied Health Research, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Tracy E', 'Initials': 'TE', 'LastName': 'Roberts', 'Affiliation': 'Institute of Applied Health Research, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Ilias', 'Initials': 'I', 'LastName': 'Goranitis', 'Affiliation': 'Melbourne School of Population and Global Health, University of Melbourne, Melbourne, VIC, Australia.'}, {'ForeName': 'Chidubem B', 'Initials': 'CB', 'LastName': 'Ogwulu', 'Affiliation': 'Institute of Applied Health Research, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Helen M', 'Initials': 'HM', 'LastName': 'Williams', 'Affiliation': 'Institute of Metabolism and Systems Research, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Ioannis D', 'Initials': 'ID', 'LastName': 'Gallos', 'Affiliation': 'Institute of Metabolism and Systems Research, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Abey', 'Initials': 'A', 'LastName': 'Eapen', 'Affiliation': 'Carver College of Medicine, University of Iowa Health Care, Iowa City, IA, USA.'}, {'ForeName': 'Jane P', 'Initials': 'JP', 'LastName': 'Daniels', 'Affiliation': ""Faculty of Medicine and Health Sciences, Queen's Medical Centre, University of Nottingham, Nottingham, UK.""}, {'ForeName': 'Amna', 'Initials': 'A', 'LastName': 'Ahmed', 'Affiliation': 'Sunderland Royal Hospital, City Hospitals Sunderland NHS Foundation Trust, Sunderland, UK.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Bender-Atik', 'Affiliation': 'Miscarriage Association, Wakefield, UK.'}, {'ForeName': 'Kalsang', 'Initials': 'K', 'LastName': 'Bhatia', 'Affiliation': 'Burnley General Hospital, East Lancashire Hospitals NHS Trust, Burnley, UK.'}, {'ForeName': 'Cecilia', 'Initials': 'C', 'LastName': 'Bottomley', 'Affiliation': 'University College Hospital, University College London Hospitals NHS Foundation Trust, London, UK.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Brewin', 'Affiliation': ""Tommy's, London, UK.""}, {'ForeName': 'Meenakshi', 'Initials': 'M', 'LastName': 'Choudhary', 'Affiliation': 'Royal Victoria Infirmary, Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Crosfill', 'Affiliation': 'Royal Preston Hospital, Lancashire Teaching Hospitals NHS Trust, Preston, UK.'}, {'ForeName': 'Shilpa', 'Initials': 'S', 'LastName': 'Deb', 'Affiliation': ""Queen's Medical Centre, Nottingham University Hospitals NHS Trust, Nottingham, UK.""}, {'ForeName': 'W Colin', 'Initials': 'WC', 'LastName': 'Duncan', 'Affiliation': ""Medical Research Council Centre for Reproductive Health, The Queen's Medical Research Institute, University of Edinburgh, Edinburgh, UK.""}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Ewer', 'Affiliation': 'Institute of Metabolism and Systems Research, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Hinshaw', 'Affiliation': 'Sunderland Royal Hospital, City Hospitals Sunderland NHS Foundation Trust, Sunderland, UK.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Holland', 'Affiliation': ""St Thomas' Hospital, Guy's and St Thomas' NHS Foundation Trust, London, UK.""}, {'ForeName': 'Feras', 'Initials': 'F', 'LastName': 'Izzat', 'Affiliation': 'University Hospital Coventry, University Hospitals Coventry and Warwickshire NHS Trust, Coventry, UK.'}, {'ForeName': 'Jemma', 'Initials': 'J', 'LastName': 'Johns', 'Affiliation': ""King's College Hospital, King's College Hospital NHS Foundation Trust, London, UK.""}, {'ForeName': 'Mary-Ann', 'Initials': 'MA', 'LastName': 'Lumsden', 'Affiliation': 'Reproductive & Maternal Medicine, School of Medicine, Dentistry and Nursing, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'Padma', 'Initials': 'P', 'LastName': 'Manda', 'Affiliation': 'The James Cook University Hospital, South Tees Hospitals NHS Foundation Trust, Middlesbrough, UK.'}, {'ForeName': 'Jane E', 'Initials': 'JE', 'LastName': 'Norman', 'Affiliation': ""Medical Research Council Centre for Reproductive Health, The Queen's Medical Research Institute, University of Edinburgh, Edinburgh, UK.""}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Nunes', 'Affiliation': 'West Middlesex University Hospital, Chelsea and Westminster Hospital NHS Foundation Trust, Isleworth, UK.'}, {'ForeName': 'Caroline E', 'Initials': 'CE', 'LastName': 'Overton', 'Affiliation': ""St Michael's Hospital, University Hospitals Bristol NHS Foundation Trust, Bristol, UK.""}, {'ForeName': 'Kathiuska', 'Initials': 'K', 'LastName': 'Kriedt', 'Affiliation': 'University College Hospital, University College London Hospitals NHS Foundation Trust, London, UK.'}, {'ForeName': 'Siobhan', 'Initials': 'S', 'LastName': 'Quenby', 'Affiliation': 'Biomedical Research Unit in Reproductive Health, Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'Sandhya', 'Initials': 'S', 'LastName': 'Rao', 'Affiliation': ""Whiston Hospital, St Helen's and Knowsley Teaching Hospitals NHS Trust, Prescot, UK.""}, {'ForeName': 'Jackie', 'Initials': 'J', 'LastName': 'Ross', 'Affiliation': ""King's College Hospital, King's College Hospital NHS Foundation Trust, London, UK.""}, {'ForeName': 'Anupama', 'Initials': 'A', 'LastName': 'Shahid', 'Affiliation': 'Whipps Cross Hospital, Barts Health NHS Trust, London, UK.'}, {'ForeName': 'Martyn', 'Initials': 'M', 'LastName': 'Underwood', 'Affiliation': 'Princess Royal Hospital, Shrewsbury and Telford Hospital NHS Trust, Telford, UK.'}, {'ForeName': 'Nirmala', 'Initials': 'N', 'LastName': 'Vaithilingham', 'Affiliation': 'Queen Alexandra Hospital, Portsmouth Hospitals NHS Trust, Portsmouth, UK.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Watkins', 'Affiliation': ""Liverpool Women's Hospital, Liverpool Women's NHS Foundation Trust, Liverpool, UK.""}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Wykes', 'Affiliation': 'East Surrey Hospital, Surrey and Sussex Healthcare NHS Trust, Redhill, UK.'}, {'ForeName': 'Andrew W', 'Initials': 'AW', 'LastName': 'Horne', 'Affiliation': ""Medical Research Council Centre for Reproductive Health, The Queen's Medical Research Institute, University of Edinburgh, Edinburgh, UK.""}, {'ForeName': 'Davor', 'Initials': 'D', 'LastName': 'Jurkovic', 'Affiliation': 'University College Hospital, University College London Hospitals NHS Foundation Trust, London, UK.'}, {'ForeName': 'Lee J', 'Initials': 'LJ', 'LastName': 'Middleton', 'Affiliation': 'Institute of Applied Health Research, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK.'}]","Health technology assessment (Winchester, England)",['10.3310/hta24330'] 2500,32604962,Background Glucocorticoid Therapy Has No Impact on Efficacy and Safety of Abatacept or Adalimumab in Patients with Rheumatoid Arthritis.,"To date, the impact of background glucocorticoids (GC) on the efficacy and safety of abatacept or adalimumab in patients with active rheumatoid arthritis (RA) is not clearly established. This post hoc analysis of (AMPLE) trial (NCT00929864) compared efficacy and safety outcomes over 2 years in patients treated with abatacept or adalimumab plus background methotrexate (MTX), who continued GC (≤10 mg/day) versus those who were not receiving GC (no-GC). Of 646 randomized patients, 317 received abatacept + MTX (161 GC, 156 no-GC) and 326 received adalimumab + MTX (162 GC, 164 no-GC). At Year 2, the adjusted mean changes from baseline in Disease Activity Score (DAS28 C-reactive protein (CRP)) and Health Assessment Questionnaire-Disability Index (HAQ-DI) were not significantly different in the GC versus no-GC subgroups receiving abatacept or adalimumab. A similar proportion of patients achieved remission, HAQ-DI score improvement ≥0.3 and radiographic progression rates. No clinically meaningful safety differences were observed between GC versus no-GC subgroups either with abatacept or adalimumab. In patients with active RA of similar baseline disease activity treated with abatacept or adalimumab plus background MTX, there was no additional value of background GC on clinical, functional or radiographic outcomes over two years.",2020,No clinically meaningful safety differences were observed between GC versus no-GC subgroups either with abatacept or adalimumab.,"['Patients with Rheumatoid Arthritis', 'patients with active rheumatoid arthritis (RA', '646 randomized patients, 317 received', 'patients with active RA of similar baseline disease activity treated with', '≤10 mg/day) versus those who were not receiving GC (no-GC']","['adalimumab', 'adalimumab + MTX', 'abatacept or adalimumab plus background methotrexate (MTX), who continued GC', 'abatacept or adalimumab', 'background glucocorticoids (GC', 'abatacept or adalimumab plus background MTX', ' Glucocorticoid Therapy', 'abatacept + MTX', 'Abatacept or Adalimumab']","['efficacy and safety outcomes', 'remission, HAQ-DI score improvement ≥0.3 and radiographic progression rates', 'Disease Activity Score (DAS28 C-reactive protein (CRP)) and Health Assessment Questionnaire-Disability Index (HAQ-DI']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0017710', 'cui_str': 'Glucocorticoid'}]","[{'cui': 'C1122087', 'cui_str': 'adalimumab'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C1619966', 'cui_str': 'abatacept'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0017710', 'cui_str': 'Glucocorticoid'}, {'cui': 'C0744425', 'cui_str': 'Glucocorticoid therapy'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0451208', 'cui_str': 'Health assessment questionnaire'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C4706353', 'cui_str': 'DAS - Disease Activity Score'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}]",646.0,0.0507699,No clinically meaningful safety differences were observed between GC versus no-GC subgroups either with abatacept or adalimumab.,"[{'ForeName': 'Yannick', 'Initials': 'Y', 'LastName': 'Degboé', 'Affiliation': 'Rheumatology Centre, Toulouse University Hospital and University Toulouse III Paul Sabatier, 31059 Toulouse, France.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Schiff', 'Affiliation': 'Rheumatology Division, University of Colorado, Denver, CO 80111, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Weinblatt', 'Affiliation': ""Department of Rheumatology & Immunology, Brigham and Women's Hospital, Boston, MA 02115, USA.""}, {'ForeName': 'Roy', 'Initials': 'R', 'LastName': 'Fleischmann', 'Affiliation': 'Department of Internal Medicine, University of Texas Southwestern Medical Center, Metroplex Clinical Research Center, Dallas, TX 75231, USA.'}, {'ForeName': 'Harris A', 'Initials': 'HA', 'LastName': 'Ahmad', 'Affiliation': 'Immunology, Bristol-Myers Squibb, Princeton, NJ 08540, USA.'}, {'ForeName': 'Arnaud', 'Initials': 'A', 'LastName': 'Constantin', 'Affiliation': 'Rheumatology Centre, Toulouse University Hospital and University Toulouse III Paul Sabatier, 31059 Toulouse, France.'}]",Journal of clinical medicine,['10.3390/jcm9062017'] 2501,32605005,"Effects of Acute Cocoa Supplementation on Postprandial Apolipoproteins, Lipoprotein Subclasses, and Inflammatory Biomarkers in Adults with Type 2 Diabetes after a High-Fat Meal.","Dyslipidemia and inflammation exacerbate postprandial metabolic stress in people with diabetes. Acute dietary supplementation with polyphenols shows promise in improving postprandial metabolic stress in type 2 diabetes (T2D). Cocoa is a rich source of dietary polyphenols with demonstrated cardioprotective effects in adults without diabetes. To date, the acute effects of cocoa on postprandial lipids and inflammation have received little attention in the presence of T2D. This report expands on our earlier observation that polyphenol-rich cocoa, given as a beverage with a fast-food-style, high-fat breakfast, increased postprandial high-density lipoprotein-cholesterol (HDL-C) in adults with T2D. We now test whether polyphenol-rich cocoa modulated postprandial apolipoproteins (Apo-A1, B), non-esterified fatty acids, nuclear magnetic resonance (NMR)-derived lipoprotein subclass profiles, and select biomarkers of inflammation following the same dietary challenge. We found that cocoa decreased NMR-derived concentrations of total very low-density lipoprotein and chylomicron particles and increased the concentration of total HDL particles over the 6-hour postprandial phase. Serum interleukin-18 was decreased by cocoa vs. placebo. Thus, polyphenol-rich cocoa may alleviate postprandial dyslipidemia and inflammation following a high-fat dietary challenge in adults with T2D. The study was registered at clinicaltrials.gov as NCT01886989.",2020,We found that cocoa decreased NMR-derived concentrations of total very low-density lipoprotein and chylomicron particles and increased the concentration of total HDL particles over the 6-hour postprandial phase.,"['people with diabetes', 'Adults with Type 2 Diabetes after a High-Fat Meal', 'adults without diabetes', 'adults with T2D', 'type 2 diabetes (T2D']","['Acute Cocoa Supplementation', 'polyphenol-rich cocoa', 'Cocoa', 'polyphenols', 'cocoa vs. placebo']","['Dyslipidemia and inflammation exacerbate postprandial metabolic stress', 'Serum interleukin-18', 'Postprandial Apolipoproteins, Lipoprotein Subclasses, and Inflammatory Biomarkers', 'concentration of total HDL particles', 'postprandial high-density lipoprotein-cholesterol (HDL-C', 'postprandial metabolic stress']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}]","[{'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0006622', 'cui_str': 'Theobroma cacao'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0071649', 'cui_str': 'Polyphenol'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0242339', 'cui_str': 'Dyslipidemia'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0436331', 'cui_str': 'Symptom aggravating factors'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C2350024', 'cui_str': 'Metabolic Stress'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0383327', 'cui_str': 'Interleukin 18'}, {'cui': 'C0003591', 'cui_str': 'Apolipoprotein'}, {'cui': 'C0023820', 'cui_str': 'Lipoprotein'}, {'cui': 'C0445604', 'cui_str': 'Subclass'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0023822', 'cui_str': 'HDL cholesterol'}]",,0.103555,We found that cocoa decreased NMR-derived concentrations of total very low-density lipoprotein and chylomicron particles and increased the concentration of total HDL particles over the 6-hour postprandial phase.,"[{'ForeName': 'Dustin W', 'Initials': 'DW', 'LastName': 'Davis', 'Affiliation': 'Department of Kinesiology and Nutrition Sciences, School of Integrated Health Sciences, University of Nevada, Las Vegas, NV 89154, USA.'}, {'ForeName': 'Rickelle', 'Initials': 'R', 'LastName': 'Tallent', 'Affiliation': 'Department of Kinesiology and Nutrition Sciences, School of Integrated Health Sciences, University of Nevada, Las Vegas, NV 89154, USA.'}, {'ForeName': 'James W', 'Initials': 'JW', 'LastName': 'Navalta', 'Affiliation': 'Department of Kinesiology and Nutrition Sciences, School of Integrated Health Sciences, University of Nevada, Las Vegas, NV 89154, USA.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Salazar', 'Affiliation': 'Department of Kinesiology and Nutrition Sciences, School of Integrated Health Sciences, University of Nevada, Las Vegas, NV 89154, USA.'}, {'ForeName': 'Timothy J', 'Initials': 'TJ', 'LastName': 'Lyons', 'Affiliation': 'Division of Endocrinology, Medical University of South Carolina, Charleston, SC 29245, USA.'}, {'ForeName': 'Arpita', 'Initials': 'A', 'LastName': 'Basu', 'Affiliation': 'Department of Kinesiology and Nutrition Sciences, School of Integrated Health Sciences, University of Nevada, Las Vegas, NV 89154, USA.'}]",Nutrients,['10.3390/nu12071902'] 2502,32605074,Reduction of High Expressed Emotion and Treatment Outcomes in Anorexia Nervosa-Caregivers' and Adolescents' Perspective.,"High expressed emotion (EE) is common in caregivers of patients with anorexia nervosa (AN) and associated with poorer outcome for patients. In this study, we examined the prevalence of high EE in caregivers of adolescents with AN and analyzed predictors for EE using multivariate linear regression models. We further analyzed whether EE is reduced by the ""Supporting Carers of Children and Adolescents with Eating Disorders in Austria"" (SUCCEAT) intervention using general linear mixed models and whether a reduction of EE predicts patients' outcomes. Caregivers were randomly allocated to the SUCCEAT workshop ( N = 50) or online intervention ( N = 50) and compared to a comparison group ( N = 49). EE and patients' outcomes were assessed at the baseline, post-intervention, and at the 12-month follow-up. Up to 47% of caregivers showed high EE. Lower caregiver skills, higher AN symptom impact, higher levels of depression and motivation to change in caregivers were significant predictors for high EE. EE significantly decreased in the SUCCEAT groups and the comparison group according to the caregivers', but not the patients' perspective. The level of reduction could partially predict subjective improvement and improvement in clinically assessed AN symptoms and body mass index of patients. Implementing interventions for caregivers addressing EE in the treatment of adolescents with AN is strongly recommended.",2020,"EE significantly decreased in the SUCCEAT groups and the comparison group according to the caregivers', but not the patients' perspective.","['caregivers of patients with anorexia nervosa (AN', ""Anorexia Nervosa-Caregivers' and Adolescents' Perspective""]","['High expressed emotion (EE', 'SUCCEAT workshop ( N = 50) or online intervention']",['EE'],"[{'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0003125', 'cui_str': 'Anorexia nervosa'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0302826', 'cui_str': 'Expressed Emotion'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0013473', 'cui_str': 'Eating disorder'}, {'cui': 'C0004348', 'cui_str': 'Austria'}, {'cui': 'C0242262', 'cui_str': 'Workshops'}, {'cui': 'C3898714', 'cui_str': 'Internet Intervention'}]","[{'cui': 'C0302826', 'cui_str': 'Expressed Emotion'}]",,0.0360736,"EE significantly decreased in the SUCCEAT groups and the comparison group according to the caregivers', but not the patients' perspective.","[{'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Philipp', 'Affiliation': 'Eating Disorders Unit, Department of Child and Adolescent Psychiatry, Medical University of Vienna, 1090 Vienna, Austria.'}, {'ForeName': 'Stefanie', 'Initials': 'S', 'LastName': 'Truttmann', 'Affiliation': 'Eating Disorders Unit, Department of Child and Adolescent Psychiatry, Medical University of Vienna, 1090 Vienna, Austria.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Zeiler', 'Affiliation': 'Eating Disorders Unit, Department of Child and Adolescent Psychiatry, Medical University of Vienna, 1090 Vienna, Austria.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Franta', 'Affiliation': 'Eating Disorders Unit, Department of Child and Adolescent Psychiatry, Medical University of Vienna, 1090 Vienna, Austria.'}, {'ForeName': 'Tanja', 'Initials': 'T', 'LastName': 'Wittek', 'Affiliation': 'Eating Disorders Unit, Department of Child and Adolescent Psychiatry, Medical University of Vienna, 1090 Vienna, Austria.'}, {'ForeName': 'Gabriele', 'Initials': 'G', 'LastName': 'Schöfbeck', 'Affiliation': 'Eating Disorders Unit, Department of Child and Adolescent Psychiatry, Medical University of Vienna, 1090 Vienna, Austria.'}, {'ForeName': 'Michaela', 'Initials': 'M', 'LastName': 'Mitterer', 'Affiliation': 'Eating Disorders Unit, Department of Child and Adolescent Psychiatry, Medical University of Vienna, 1090 Vienna, Austria.'}, {'ForeName': 'Dunja', 'Initials': 'D', 'LastName': 'Mairhofer', 'Affiliation': 'Eating Disorders Unit, Department of Child and Adolescent Psychiatry, Medical University of Vienna, 1090 Vienna, Austria.'}, {'ForeName': 'Annika', 'Initials': 'A', 'LastName': 'Zanko', 'Affiliation': 'Parkland Clinic, Clinic for Psychosomatic Medicine and Psychotherapy, 34537 Bad Wildungen, Germany.'}, {'ForeName': 'Hartmut', 'Initials': 'H', 'LastName': 'Imgart', 'Affiliation': 'Parkland Clinic, Clinic for Psychosomatic Medicine and Psychotherapy, 34537 Bad Wildungen, Germany.'}, {'ForeName': 'Ellen', 'Initials': 'E', 'LastName': 'Auer-Welsbach', 'Affiliation': 'Department for Neurology and Child and Adolescent Psychiatry, 9020 Klagenfurt am Wörthersee, Austria.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Treasure', 'Affiliation': ""Section of Eating Disorders, Department of Psychological Medicine, Institute of Psychiatry, Psychology & Neuroscience, King's College London, London WC2R 2LS, UK.""}, {'ForeName': 'Gudrun', 'Initials': 'G', 'LastName': 'Wagner', 'Affiliation': 'Eating Disorders Unit, Department of Child and Adolescent Psychiatry, Medical University of Vienna, 1090 Vienna, Austria.'}, {'ForeName': 'Andreas F K', 'Initials': 'AFK', 'LastName': 'Karwautz', 'Affiliation': 'Eating Disorders Unit, Department of Child and Adolescent Psychiatry, Medical University of Vienna, 1090 Vienna, Austria.'}]",Journal of clinical medicine,['10.3390/jcm9072021'] 2503,32605075,Lifestyle Intervention on Body Weight and Physical Activity in Patients with Breast Cancer can reduce the Risk of Death in Obese Women: The EMILI Study.,": Background obesity and sedentary lifestyle have been shown to negatively affect survival in breast cancer (BC). The purpose of this study was to test the efficacy of a lifestyle intervention on body mass index (BMI) and physical activity (PA) levels among BC survivors in Modena, Italy, in order to show an outcome improvement in obese and overweight patients. METHODS This study is a single-arm experimental design, conducted between November 2009 and May 2016 on 430 women affected by BC. Weight, BMI, and PA were assessed at baseline, at 12 months, and at the end of the study. Survival curves were estimated among normal, overweight, and obese patients. RESULTS Mean BMI decreased from baseline to the end of the study was equal to 2.9% ( p = 0.065) in overweight patients and 3.3% in obese patients ( p = 0.048). Mean PA increase from baseline to the end of the study was equal to 125% ( p < 0.001) in normal patients, 200% ( p < 0.001) in overweight patients and 100% ( p < 0.001) in obese patients. After 70 months of follow-up, the 5-year overall survival (OS) rate was 96%, 96%, and 93%, respectively in normal, obese, and overweight patients. Overweight patients had significantly worse OS than normal ones (HR = 3.69, 95%CI = 1.82-4.53 p = 0.027) whereas no statistically significant differences were seen between obese and normal patients (HR 2.45, 95%CI = 0.68-8.78, p = 0.169). CONCLUSIONS A lifestyle intervention can lead to clinically meaningful weight loss and increase PA in patients with BC. These results could contribute to improving the OS in obese patients compared to overweight ones.",2020,"Overweight patients had significantly worse OS than normal ones (HR = 3.69, 95%CI = 1.82-4.53 p = 0.027) whereas no statistically significant differences were seen between obese and normal patients (HR 2.45, 95%CI = 0.68-8.78, p = 0.169). ","['patients with BC', 'November 2009 and May 2016 on 430 women affected by BC', 'obese patients', 'Patients with Breast Cancer', 'obese and overweight patients', 'Obese Women']","['Lifestyle Intervention', 'lifestyle intervention']","['Weight, BMI, and PA', '5-year overall survival (OS) rate', 'body mass index (BMI) and physical activity (PA) levels', 'Mean BMI', 'Survival curves', 'Mean PA increase', 'Body Weight and Physical Activity', 'Risk of Death']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}]","[{'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",430.0,0.0353551,"Overweight patients had significantly worse OS than normal ones (HR = 3.69, 95%CI = 1.82-4.53 p = 0.027) whereas no statistically significant differences were seen between obese and normal patients (HR 2.45, 95%CI = 0.68-8.78, p = 0.169). ","[{'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Cortesi', 'Affiliation': 'Department of Oncology and Hematology, Azienda Ospedaliero-Universitaria di Modena, 41124 Modena, Italy.'}, {'ForeName': 'Federica', 'Initials': 'F', 'LastName': 'Sebastiani', 'Affiliation': 'Department of Oncology and Hematology, Azienda Ospedaliero-Universitaria di Modena, 41124 Modena, Italy.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Iannone', 'Affiliation': 'Department of Surgery, Medicine, Dentistry and Morphological Sciences with Transplant Surgery, Oncology and Regenerative Medicine Relevance, University of Modena and Reggio Emilia, 41124 Modena, Italy.'}, {'ForeName': 'Luigi', 'Initials': 'L', 'LastName': 'Marcheselli', 'Affiliation': 'Department of Oncology and Hematology, Azienda Ospedaliero-Universitaria di Modena, 41124 Modena, Italy.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Venturelli', 'Affiliation': 'Department of Oncology and Hematology, Azienda Ospedaliero-Universitaria di Modena, 41124 Modena, Italy.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Piombino', 'Affiliation': 'Department of Oncology and Hematology, Azienda Ospedaliero-Universitaria di Modena, 41124 Modena, Italy.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Toss', 'Affiliation': 'Department of Oncology and Hematology, Azienda Ospedaliero-Universitaria di Modena, 41124 Modena, Italy.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Federico', 'Affiliation': 'Department of Oncology and Hematology, Azienda Ospedaliero-Universitaria di Modena, 41124 Modena, Italy.'}]",Cancers,['10.3390/cancers12071709'] 2504,30944249,Dietary unsaturated fat increases HDL metabolic pathways involving apoE favorable to reverse cholesterol transport.,"BACKGROUND HDL that contains apolipoprotein E (apoE) is a subspecies especially active in steps in reverse cholesterol transport, a process that brings cholesterol from peripheral cells to the liver. Here, we studied the effect of dietary unsaturated fat compared with carbohydrate on the metabolism of HDL containing apoE. METHODS We enrolled 9 adults who were overweight or obese and had below-average HDL-cholesterol in a crossover study of a high-fat diet, primarily unsaturated, and a low-fat, high-carbohydrate diet. A metabolic tracer study was performed after each diet period. RESULTS Dietary fat increased the secretion, metabolism, and clearance of HDL subspecies containing apoE. Dietary fat increased the rate of clearance of large cholesterol-rich HDL containing apoE and increased their conversion to small HDL containing apoE, indicating selective cholesterol ester delivery to the liver. The high-unsaturated-fat diet did not affect the metabolism of HDL lacking apoE. CONCLUSION HDL containing apoE is a diet-responsive metabolic pathway that renders HDL more biologically active in reverse cholesterol transport. This may be a mechanism by which unsaturated fat protects against coronary heart disease. Protein-based HDL subspecies such as HDL containing apoE may be used to identify additional atheroprotective treatment targets not evident in the total HDL-cholesterol measurement. TRIAL REGISTRATION ClinicalTrials.gov NCT01399632. FUNDING NIH and the National Center for Advancing Translational Science.",2019,The high-unsaturated-fat diet did not affect the metabolism of HDL lacking,"['We enrolled 9 adults who were overweight or obese and had below-average HDL-cholesterol in a crossover study of a high-fat diet, primarily unsaturated, and a low-fat, high-carbohydrate diet']",['dietary unsaturated fat compared with carbohydrate'],"['secretion, metabolism, and clearance of HDL subspecies', 'metabolism of HDL lacking']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0018667', 'cui_str': 'Cholesterol in high density lipoprotein subfraction 2'}, {'cui': 'C0150097', 'cui_str': 'Crossover Trials'}, {'cui': 'C0521974', 'cui_str': 'High fat diet'}, {'cui': 'C0522535', 'cui_str': 'Unsaturated'}, {'cui': 'C0242970', 'cui_str': 'Low fat diet'}, {'cui': 'C0259835', 'cui_str': 'High carbohydrate diet'}]","[{'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0015678', 'cui_str': 'Unsaturated fat'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}]","[{'cui': 'C0036536', 'cui_str': 'secretion'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0332268', 'cui_str': 'Lacking'}]",9.0,0.023758,The high-unsaturated-fat diet did not affect the metabolism of HDL lacking,"[{'ForeName': 'Allyson M', 'Initials': 'AM', 'LastName': 'Morton', 'Affiliation': 'Department of Nutrition, Harvard T.H. Chan School of Public Health, Boston, Massachusetts, USA.'}, {'ForeName': 'Jeremy D', 'Initials': 'JD', 'LastName': 'Furtado', 'Affiliation': 'Department of Nutrition, Harvard T.H. Chan School of Public Health, Boston, Massachusetts, USA.'}, {'ForeName': 'Carlos O', 'Initials': 'CO', 'LastName': 'Mendivil', 'Affiliation': 'Department of Nutrition, Harvard T.H. Chan School of Public Health, Boston, Massachusetts, USA.'}, {'ForeName': 'Frank M', 'Initials': 'FM', 'LastName': 'Sacks', 'Affiliation': 'Department of Nutrition, Harvard T.H. Chan School of Public Health, Boston, Massachusetts, USA.'}]",JCI insight,['10.1172/jci.insight.124620'] 2505,31010315,Clinical Trial Recruitment and Retention of College Students with Type 1 Diabetes via Social Media: An Implementation Case Study.,"BACKGROUND We sought to quantify the efficiency and acceptability of Internet-based recruitment for engaging an especially hard-to-reach cohort (college-students with type 1 diabetes, T1D) and to describe the approach used for implementing a health-related trial entirely online using off-the-shelf tools inclusive of participant safety and validity concerns. METHOD We recruited youth (ages 17-25 years) with T1D via a variety of social media platforms and other outreach channels. We quantified response rate and participant characteristics across channels with engagement metrics tracked via Google Analytics and participant survey data. We developed decision rules to identify invalid (duplicative/false) records (N = 89) and compared them to valid cases (N = 138). RESULTS Facebook was the highest yield recruitment source; demographics differed by platform. Invalid records were prevalent; invalid records were more likely to be recruited from Twitter or Instagram and differed from valid cases across most demographics. Valid cases closely resembled characteristics obtained from Google Analytics and from prior data on platform user-base. Retention was high, with complete follow-up for 88.4%. There were no safety concerns and participants reported high acceptability for future recruitment via social media. CONCLUSIONS We demonstrate that recruitment of college students with T1D into a longitudinal intervention trial via social media is feasible, efficient, acceptable, and yields a sample representative of the user-base from which they were drawn. Given observed differences in characteristics across recruitment channels, recruiting across multiple platforms is recommended to optimize sample diversity. Trial implementation, engagement tracking, and retention are feasible with off-the-shelf tools using preexisting platforms.",2019,"We developed decision rules to identify invalid (duplicative/false) records (N = 89) and compared them to valid cases (N = 138). ","['college students with T1D', 'We recruited youth (ages 17-25 years) with T1D via a variety of social media platforms and other outreach channels', 'College Students with Type 1 Diabetes via Social Media']",[],[],"[{'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C3179065', 'cui_str': 'Social Medium'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0439799', 'cui_str': 'Channel'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}]",[],[],138.0,0.0999401,"We developed decision rules to identify invalid (duplicative/false) records (N = 89) and compared them to valid cases (N = 138). ","[{'ForeName': 'Lauren E', 'Initials': 'LE', 'LastName': 'Wisk', 'Affiliation': ""1 Division of Adolescent/Young Adult Medicine, Boston Children's Hospital, Boston, MA, USA.""}, {'ForeName': 'Eliza B', 'Initials': 'EB', 'LastName': 'Nelson', 'Affiliation': ""1 Division of Adolescent/Young Adult Medicine, Boston Children's Hospital, Boston, MA, USA.""}, {'ForeName': 'Kara M', 'Initials': 'KM', 'LastName': 'Magane', 'Affiliation': ""1 Division of Adolescent/Young Adult Medicine, Boston Children's Hospital, Boston, MA, USA.""}, {'ForeName': 'Elissa R', 'Initials': 'ER', 'LastName': 'Weitzman', 'Affiliation': ""1 Division of Adolescent/Young Adult Medicine, Boston Children's Hospital, Boston, MA, USA.""}]",Journal of diabetes science and technology,['10.1177/1932296819839503'] 2506,32608151,"A randomized split-face, investigator-blinded study of a picosecond Alexandrite laser for post-inflammatory erythema and acne scars.","The 755 nm picosecond Alexandrite laser has been demonstrated to be effective and well tolerated in patients with acne scars. In this split-face, investigator-blinded study, 16 patients with post-inflammatory erythema (PIE) and acne scars were randomized to receive laser treatment on half the face, with the other half serving as a control. The treatment side demonstrated a significant improvement in both PIE and scars compared to the baseline and also when compared to the control side. Treatment was well-tolerated, with only transient and mild erythema and edema reported as side-effects. In our study the picosecond Alexandrite laser was safe and effective in the treatment of PIE and acne scars. Comprehensive treatment outcomes should be taken into consideration when deciding on which device to use. This article is protected by copyright. All rights reserved.",2020,The treatment side demonstrated a significant improvement in both PIE and scars compared to the baseline and also when compared to the control side.,"['16 patients with post-inflammatory erythema (PIE) and acne scars', 'post-inflammatory erythema and acne scars', 'patients with acne scars']","['picosecond Alexandrite laser', 'laser treatment']","['PIE and scars', 'mild erythema and edema', 'tolerated']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0423783', 'cui_str': 'Acne scar'}]","[{'cui': 'C0392245', 'cui_str': 'Alexandrite laser device'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0008767', 'cui_str': 'Scarring'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0013604', 'cui_str': 'Edema'}]",16.0,0.0115798,The treatment side demonstrated a significant improvement in both PIE and scars compared to the baseline and also when compared to the control side.,"[{'ForeName': 'Xiang', 'Initials': 'X', 'LastName': 'Wen', 'Affiliation': 'Department of Dermatology, West China Hospital of Sichuan University, Chengdu, Sichuan, China.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Dermatology, West China Hospital of Sichuan University, Chengdu, Sichuan, China.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Hamblin', 'Affiliation': 'Wellman Center for Photomedicine, Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'Xian', 'Initials': 'X', 'LastName': 'Jiang', 'Affiliation': 'Department of Dermatology, West China Hospital of Sichuan University, Chengdu, Sichuan, China.'}]",Dermatologic therapy,['10.1111/dth.13941'] 2507,32608166,Safety and Efficacy of Platelet Rich Plasma Versus Carboxytherapy in the Treatment of Atrophic Scars: A Comparative Clinical and Histopathological study.,"BACKGROUND Atrophic scars that occur after surgical procedure or trauma are considered as a cosmetic problem for patients. Atrophic scarring results usually during wound healing with inadequate production of collagen and connective tissue. Factors that precipitate to the formation of depressed scars include: individual variations in wound healing, wound tension, tissue apposition, and scar contraction. OBJECTIVES To evaluate the safety and efficacy of PRP versus carboxytherapy in treatment of atrophic scars. METHODS This study included 40 patients with atrophic scars divided into 2 groups; group A including 20 patients received PRP injection, group B including 20 patients received CO2 injection. They received the treatment every 4 weeks for 4 sessions and had follow up for 6 months after the end of treatment. Skin biopsies were taken before and after treatment to evaluate clinical results. RESULTS There was statistically significant difference between both groups in treating atrophic scars, regarding clinical improvement and patients' satisfaction with better results in group B. Histopathological examination showed significant expression of MMP-1 in group B more than group A. CONCLUSIONS Both methods were safe and effective with minimal side effects with better improvement in patients treated with carboxytherapy than those treated with PRP. This article is protected by copyright. All rights reserved.",2020,"There was statistically significant difference between both groups in treating atrophic scars, regarding clinical improvement and patients' satisfaction with better results in group B. Histopathological examination showed significant expression of MMP-1 in group B more than group A. CONCLUSIONS ","['Atrophic Scars', '40 patients with atrophic scars divided into 2 groups; group A including 20 patients received']","['Platelet Rich Plasma Versus Carboxytherapy', 'PRP', 'carboxytherapy', 'CO2 injection', 'PRP injection', 'PRP versus carboxytherapy']","['safety and efficacy', 'wound healing, wound tension, tissue apposition, and scar contraction', 'treating atrophic scars', 'expression of MMP-1']","[{'cui': 'C0162154', 'cui_str': 'Atrophic scar'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0370220', 'cui_str': 'Platelet rich plasma'}, {'cui': 'C0032027', 'cui_str': 'Pityriasis rubra pilaris'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C0233494', 'cui_str': 'Tension'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0008767', 'cui_str': 'Scarring'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0162154', 'cui_str': 'Atrophic scar'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C2001899', 'cui_str': 'MMP1 protein, human'}]",40.0,0.0223083,"There was statistically significant difference between both groups in treating atrophic scars, regarding clinical improvement and patients' satisfaction with better results in group B. Histopathological examination showed significant expression of MMP-1 in group B more than group A. CONCLUSIONS ","[{'ForeName': 'Samia O', 'Initials': 'SO', 'LastName': 'Nassar', 'Affiliation': 'Dermatology and Venereology, Faculty of medicine, Tanta University, Tanta, Egypt.'}, {'ForeName': 'Rania A R', 'Initials': 'RAR', 'LastName': 'Eltatawy', 'Affiliation': 'Dermatology and Venereology, Faculty of medicine, Tanta University, Tanta, Egypt.'}, {'ForeName': 'Ghada F R', 'Initials': 'GFR', 'LastName': 'Hassan', 'Affiliation': 'Dermatology and Venereology, Faculty of medicine, Tanta University, Tanta, Egypt.'}]",Dermatologic therapy,['10.1111/dth.13942'] 2508,32608179,'Virtual experience' as an intervention before a positron emission tomography/CT scan may ease patients' anxiety and improve image quality.,"INTRODUCTION The aim of our study was to investigate the effect of a 'virtual experience' on reducing people's anxiety levels and improving image quality. METHODS This study included 200 people who underwent 18 F-FDG PET/CT scan for the first time. Healthy people (n = 100) and patients (n = 100) were randomly divided into a control group and an intervention group. In the intervention group, we used a 'virtual experience' as an intervention before the scan. We used the Spielberger State-Trait Anxiety Inventory (STAI) and satisfaction questionnaires for evaluation. Additionally, the image quality was analysed. RESULTS In the control group, more patients presented anxiety than healthy people (26(52%) versus 15(30%)) (P = 0.041). However, when the 'virtual experience' was provided, the number of cases of anxiety in the patient group decreased to 19(38%). Furthermore, patients in the intervention group had lower STAI-related scores than those in the control group (STAI-S: 37.08 ± 9.42 versus 43.34 ± 10.49, P = 0.109; STAI-T: 36.24 ± 9.55 versus 40.72 ± 9.00, P = 0.019). With respect to image quality, people who had higher STAI-related scores were more likely to have unqualified images. CONCLUSION A 'virtual experience' provided by an audio-visual installation can ease patients' anxiety and improve image quality.",2020,"With respect to image quality, people who had higher STAI-related scores were more likely to have unqualified images. ","['200 people who underwent 18 F-FDG PET/CT scan for the first time', 'Healthy people (n\xa0=\xa0100) and patients (n\xa0=\xa0100']","['virtual experience', 'positron emission tomography/CT scan']","[""people's anxiety levels"", 'lower STAI-related scores', 'Spielberger State-Trait Anxiety Inventory (STAI) and satisfaction questionnaires', 'number of cases of anxiety']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0046056', 'cui_str': 'Fluorodeoxyglucose F18'}, {'cui': 'C1699633', 'cui_str': 'Positron emission tomography with computed tomography'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0032743', 'cui_str': 'Positron emission tomography'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}]","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0564474', 'cui_str': 'Level of anxiety'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0683457', 'cui_str': 'State-trait anger expression inventory'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0451497', 'cui_str': 'Spielberger state-trait anxiety inventory'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",200.0,0.0376366,"With respect to image quality, people who had higher STAI-related scores were more likely to have unqualified images. ","[{'ForeName': 'Yuyun', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'Department of Nuclear Medicine, Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Yifei', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'Department of Nuclear Medicine, Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Qin', 'Affiliation': 'Department of Nuclear Medicine, Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Yingjian', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Nuclear Medicine, Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Huiyu', 'Initials': 'H', 'LastName': 'Yuan', 'Affiliation': 'Department of Nuclear Medicine, Fudan University Shanghai Cancer Center, Shanghai, China.'}, {'ForeName': 'Zhongyi', 'Initials': 'Z', 'LastName': 'Yang', 'Affiliation': 'Department of Nuclear Medicine, Fudan University Shanghai Cancer Center, Shanghai, China.'}]",Journal of medical imaging and radiation oncology,['10.1111/1754-9485.13078'] 2509,32608277,Indicator of early kidney injury in adolescents with polycystic ovary syndrome: Can urine NGAL level be?,"Introduction and Purpose: The Urinary Neutrophil-gelatinase associated lipocalin (NGAL) levels which are a biomarker for early diagnosis of kidney damage that may develop in patients with Polycystic Ovary Syndrome (PCOS) were investigated in the study. Material and Methods: The 30 patients diagnosed with Polycystic Ovarian Syndrome between the ages of 13 and 18 who applied to the Yuzuncu Yil University General Children's Outpatient Clinic were included in the PCOS group and 30 healthy adolescents without any known acute or chronic illness and drug use were included in the control group. Findings: Urine NGAL value was 842.204 ± 21.561 in PCOS group and 775.379 ± 23.98 in control group. NGAL level in PCOS group was statistically significantly higher than control group (p: .045). When we examine the relationship between dyslipidemia and PCOS; While dyslipidemia was positive in 10 (33.7%) patients in the PCOS group, it was negative in 20 (66.7%) patients. While 1 patient had dyslipidemia, 29 patients did not have dyslipidemia in the control group. A significant relationship was found between dyslipidemia and PCOS (p: .005). Conclusion: We found that subclinical kidney dysfunction started in early stage patients in PCOS in our study. The urine NGAL level was thought to increase in response to increased oxidative stress in PCOS. We found no relationship between, insulin resistance and urea, BUN, creatinine and NGAL levels. However, we found a negative correlation between NGAL level and LDL. In addition, dyslipidemia, insulin resistance and ALT elevation were detected in the PCOS group.",2020,NGAL level in PCOS group was statistically significantly higher than control group (p: .045).,"['patients with Polycystic Ovary Syndrome (PCOS', ""30 patients diagnosed with Polycystic Ovarian Syndrome between the ages of 13 and 18 who applied to the Yuzuncu Yil University General Children's Outpatient Clinic were included in the PCOS group and 30 healthy adolescents without any known acute or chronic illness and drug use were included in the control group"", 'adolescents with polycystic ovary syndrome']",['Urinary Neutrophil-gelatinase associated lipocalin (NGAL'],"['dyslipidemia', 'oxidative stress', 'Urine NGAL value', 'dyslipidemia and PCOS', 'dyslipidemia, insulin resistance and ALT elevation', 'NGAL level', 'insulin resistance and urea, BUN, creatinine and NGAL levels']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032460', 'cui_str': 'Polycystic ovary syndrome'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C1632850', 'cui_str': 'Apply'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0686747', 'cui_str': 'Well adolescent'}, {'cui': 'C0205309', 'cui_str': 'Known'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}, {'cui': 'C0449889', 'cui_str': 'Drug used'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}]","[{'cui': 'C0027950', 'cui_str': 'Polymorphonuclear leukocyte'}, {'cui': 'C0206528', 'cui_str': 'Gelatinase'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C1956074', 'cui_str': 'Lipocalin'}, {'cui': 'C0215955', 'cui_str': 'LCN2 protein, human'}]","[{'cui': 'C0242339', 'cui_str': 'Dyslipidemia'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0215955', 'cui_str': 'LCN2 protein, human'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0032460', 'cui_str': 'Polycystic ovary syndrome'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0041942', 'cui_str': 'Urea'}, {'cui': 'C0005845', 'cui_str': 'Blood urea nitrogen measurement'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}]",30.0,0.0495967,NGAL level in PCOS group was statistically significantly higher than control group (p: .045).,"[{'ForeName': 'Serap', 'Initials': 'S', 'LastName': 'Karaman', 'Affiliation': 'Department of Pediatric, Yuzuncu Yil University, Van, Turkey.'}, {'ForeName': 'Enis', 'Initials': 'E', 'LastName': 'Sabancıoğulları', 'Affiliation': 'Department of Pediatric, Yuzuncu Yil University, Van, Turkey.'}, {'ForeName': 'Erbil', 'Initials': 'E', 'LastName': 'Karaman', 'Affiliation': 'Medical Faculty, Obstetric and Gynecology, Yuzuncu Yil University, Van, Turkey.'}, {'ForeName': 'Murat', 'Initials': 'M', 'LastName': 'Başaranoğlu', 'Affiliation': 'Department of Pediatric, Yuzuncu Yil University, Van, Turkey.'}, {'ForeName': 'Mecnun', 'Initials': 'M', 'LastName': 'Çetin', 'Affiliation': 'Medical Faculty, Department of Pediatric Cardiology, Yuzuncu Yil University, Van, Turkey.'}, {'ForeName': 'Kamuran', 'Initials': 'K', 'LastName': 'Karaman', 'Affiliation': 'Medical Faculty, Department of Pediatric Hematology, Yuzuncu Yil University, Van, Turkey.'}]",Gynecological endocrinology : the official journal of the International Society of Gynecological Endocrinology,['10.1080/09513590.2020.1787377'] 2510,32608315,"Electromagnetic navigation system for acetabular component placement in total hip arthroplasty is more precise and accurate than the freehand technique: a randomized, controlled trial with 84 patients.","Background and purpose - The accuracy of conventional navigation systems depends on precise registration of bony landmarks. We investigated the clinical use of electromagnetic navigation (EMN), with a unique device for precise determination of the anterior pelvic plane.Patients and methods - We randomly allocated patients scheduled for total hip arthroplasty into 2 groups of 42 patients each. In the study group, cups were placed at the predetermined target angles (inclination: 42.5°; anteversion: 15°) with the support of EMN. In the control group, cups were placed freehand aiming at the same target angles. Postoperatively the true position of the cup was determined using computed tomography scan of the pelvis. Precision (root mean squared error, RMSE) bias (mean bias error, ME), accuracy, and duration of surgery were compared between the methods.Results - Cup anteversion was more accurate and precise in the navigated group. The ME in the navigated and freehand group was -1.7° (95% CI -2.4 to 1.1) and -4.5° (CI -6.5 to 2.5), respectively. The RMSE in the navigated and freehand group was 2.8° (CI 2.3-3.2) and 8.0° (CI 6.3-9.5), respectively. The inclination was also more precise in the navigated group, with the RMSE in the navigated and freehand group at 4.6° (CI 3.4-5.9) and 6.5° (CI 5.4-7.5), respectively. The accuracy of the inclination and the duration of surgeries were similar between the groups.Interpretation - Cup placement with the help of EMN is more precise than the freehand technique and it does not affect the duration of surgery.",2020,"The inclination was also more precise in the navigated group, with the RMSE in the navigated and freehand group at 4.6° (CI 3.4-5.9) and 6.5° (CI 5.4-7.5), respectively.",['84 patients'],"['Electromagnetic navigation system', 'acetabular component placement', 'electromagnetic navigation (EMN', 'total hip arthroplasty']","['accuracy of the inclination and the duration of surgeries', 'Precision (root mean squared error, RMSE) bias (mean bias error, ME), accuracy, and duration of surgery']","[{'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0013838', 'cui_str': 'Electromagnetics'}, {'cui': 'C4075648', 'cui_str': 'Navigation system'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0040508', 'cui_str': 'Total replacement of hip'}]","[{'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0005346', 'cui_str': 'Biases'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}]",,0.0535289,"The inclination was also more precise in the navigated group, with the RMSE in the navigated and freehand group at 4.6° (CI 3.4-5.9) and 6.5° (CI 5.4-7.5), respectively.","[{'ForeName': 'Rene', 'Initials': 'R', 'LastName': 'Mihalič', 'Affiliation': 'Valdoltra Orthopaedic Hospital, Ankaran.'}, {'ForeName': 'Jurij', 'Initials': 'J', 'LastName': 'Zdovc', 'Affiliation': 'University of Ljubljana, Faculty of Pharmacy, Ljubljana.'}, {'ForeName': 'Janez', 'Initials': 'J', 'LastName': 'Mohar', 'Affiliation': 'Valdoltra Orthopaedic Hospital, Ankaran.'}, {'ForeName': 'Rihard', 'Initials': 'R', 'LastName': 'Trebše', 'Affiliation': 'Valdoltra Orthopaedic Hospital, Ankaran.'}]",Acta orthopaedica,['10.1080/17453674.2020.1783073'] 2511,32608933,Rotational flywheel training in youth female team sport athletes: could inter-repetition movement variability be beneficial?,"BACKGROUND The aim of this study was to analyse the effects of an inter-repetition variable rotational flywheel training program (Variable) over standard rotational flywheel training (Standard). METHODS Twenty-four youth female team-sports players were randomly assigned to both training groups (Variable, n = 12; Standard, n = 12), which consisted of 1 set of 3 rotational flywheel exercises x 10-12 repetitions, biweekly for a period of 6-weeks. The participants included in Variable group were instructed to perform the movement randomly in one of the three directions (0o, 45o right, and 45o left). Measurements included reactive strength, jumping, change of direction, and sprinting tests; patellar tendon condition was also assessed. RESULTS Substantial improvements were found in vertical jump with left leg (16.9%), lateral jump with right leg (13.6%), and patellar condition in left leg (4.1%) for Standard group, but also in reactive strength index in right leg landing (33.9%), vertical jump with right (10.1%) and left leg (12.0%) for Variable group. A significant interaction effect (group x time) wasobserved on patellar condition in right leg (F = 10.02, p < 0.01, η 2 = 0.37), favoring Variable group. CONCLUSIONS Rotational flywheel training programs were beneficial for youth-female team-sports athletes, although the movement variability may play a key role to develop different and specific physical adaptations.",2020,"RESULTS Substantial improvements were found in vertical jump with left leg (16.9%), lateral jump with right leg (13.6%), and patellar condition in left leg (4.1%) for Standard group, but also in reactive strength index in right leg landing (33.9%), vertical jump with right (10.1%) and left leg (12.0%) for Variable group.","['youth female team sport athletes', 'youth-female team-sports athletes', 'Twenty-four youth female team-sports players']","['inter-repetition variable rotational flywheel training program (Variable) over standard rotational flywheel training (Standard', 'Rotational flywheel training programs', 'Rotational flywheel training']","['reactive strength index in right leg landing', 'left leg', 'lateral jump with right leg', 'patellar condition in left leg', 'patellar condition in right leg', 'reactive strength, jumping, change of direction, and sprinting tests; patellar tendon condition', 'vertical jump with left leg']","[{'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0038039', 'cui_str': 'Sport'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C3715070', 'cui_str': '24'}]","[{'cui': 'C0205103', 'cui_str': 'Intermediate'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0445237', 'cui_str': 'Rotational'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0205332', 'cui_str': 'Reactive'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0230415', 'cui_str': 'Structure of right lower limb'}, {'cui': 'C0557668', 'cui_str': 'Landing'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0030647', 'cui_str': 'Bone structure of patella'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0230443', 'cui_str': 'Structure of left lower leg'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0439755', 'cui_str': 'Directions'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0206332', 'cui_str': 'Structure of patellar ligament'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}]",24.0,0.0207872,"RESULTS Substantial improvements were found in vertical jump with left leg (16.9%), lateral jump with right leg (13.6%), and patellar condition in left leg (4.1%) for Standard group, but also in reactive strength index in right leg landing (33.9%), vertical jump with right (10.1%) and left leg (12.0%) for Variable group.","[{'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Arede', 'Affiliation': 'Research Center in Sports Sciences, Health Sciences and Human Development, CIDESD, University of Trás-os-Montes and Alto Douro, Vila Real, Portugal - jorge_arede@hotmail.com.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Gonzalo-Skok', 'Affiliation': 'Faculty of Health Sciences, University of San Jorge, Zaragoza, Spain.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Bishop', 'Affiliation': 'Middlesex University, London, UK.'}, {'ForeName': 'Wolfgang I', 'Initials': 'WI', 'LastName': 'Schöllhorn', 'Affiliation': 'Institute of Sports Science, Johannes Gutenberg University Mainz, Mainz, Germany.'}, {'ForeName': 'Nuno', 'Initials': 'N', 'LastName': 'Leite', 'Affiliation': 'Research Center in Sports Sciences, Health Sciences and Human Development, CIDESD, University of Trás-os-Montes and Alto Douro, Vila Real, Portugal.'}]",The Journal of sports medicine and physical fitness,['10.23736/S0022-4707.20.10962-9'] 2512,32608934,Effects of resistance training combined with ischemic preconditioning on muscle size and strength in resistance-trained individuals.,"BACKGROUND The present study investigated the effects of resistance training combined with ischemic preconditioning (IPC) on muscle size and strength in resistance-trained men. METHODS Sixteen resistance-trained men were divided into two groups (Placebo and IPC) and trained twice a week for 6 weeks. Preconditioning protocols consisted of four, 5-min cycling bouts of ischemia/placebo (250 or 10 mmHg, respectively) interspersed with 5 min of reperfusion(without pressure) alternated in each leg. Thirty minutes after the preconditioning protocol, participants performed 4 sets to concentric failure at 75% of one repetition-maximum (1-RM) in unilateral knee extension exercise. Muscle thickness (ultrasound) and 1RM were assessed at baseline and 72 hours after the last training session. ANCOVA was used to compare muscle thickness and 1RM changes, using muscle thickness and 1-RM baseline values, respectively, as covariates. Significance level was set at p < 0.05. RESULTS Average of number of repetitions was higher in IPC compared to Placebo (13 ± 4 and 11 ± 2, respectively; p = 0.0002). Muscle thickness did not change in either group from pre to post-6 weeks (p = 0.32). IPC improved 1-RM more than Placebo (p = 0.04). CONCLUSIONS IPC may augment greater strength gains in resistance-trained men due to an increase in training volume.",2020,"IPC improved 1-RM more than Placebo (p = 0.04). ","['resistance-trained men', 'resistance-trained individuals', 'Sixteen resistance-trained men']","['Placebo', 'resistance training combined with ischemic preconditioning (IPC', 'resistance training combined with ischemic preconditioning', 'repetition-maximum (1-RM) in unilateral knee extension exercise', 'Placebo and IPC', 'ischemia/placebo']","['strength gains', 'Muscle thickness', 'number of repetitions', 'muscle thickness and 1RM changes, using muscle thickness and 1-RM baseline values', 'IPC improved 1-RM', 'muscle size and strength', 'Muscle thickness (ultrasound) and 1RM']","[{'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C3715157', 'cui_str': '16'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0376466', 'cui_str': 'Ischemic Pre-Conditioning'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0022116', 'cui_str': 'Ischemia'}]","[{'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0376466', 'cui_str': 'Ischemic Pre-Conditioning'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0456389', 'cui_str': 'Size'}]",,0.116078,"IPC improved 1-RM more than Placebo (p = 0.04). ","[{'ForeName': 'Leonardo', 'Initials': 'L', 'LastName': 'Carvalho', 'Affiliation': 'Department of Sport Sciences, School of Physical Education, University of Campinas, Campinas, Brazil.'}, {'ForeName': 'Vinícius', 'Initials': 'V', 'LastName': 'Concon', 'Affiliation': 'Department of Sport Sciences, School of Physical Education, University of Campinas, Campinas, Brazil.'}, {'ForeName': 'Márcio', 'Initials': 'M', 'LastName': 'Meloni', 'Affiliation': 'Department of Sport Sciences, School of Physical Education, University of Campinas, Campinas, Brazil.'}, {'ForeName': 'Eduardo O', 'Initials': 'EO', 'LastName': 'De Souza', 'Affiliation': 'Department of Health Sciences and Human Performance, University of Tampa, Tampa, FL, USA.'}, {'ForeName': 'Renato', 'Initials': 'R', 'LastName': 'Barroso', 'Affiliation': 'Department of Sport Sciences, School of Physical Education, University of Campinas, Campinas, Brazil - rbarroso@unicamp.br.'}]",The Journal of sports medicine and physical fitness,['10.23736/S0022-4707.20.11032-6'] 2513,32608989,Integrated Yoga Practice in Cardiac Rehabilitation Program: A Randomized Control Trial.,"Background: Coronary artery disease (CAD) is a detrimental noncommunicable disease, which is increasing due to sedentary lifestyle and urbanization in the young population. It is further elevated with risk factors such as stress, anxiety, depression, an increase in triglycerides, dyslipidemia, hyperglycemia, hypertension, and so on, which manifests as atherosclerotic disease. Yoga-based lifestyle intervention is a noninvasive effective treatment method to control and prevent cardiac risk factors in CAD patients. Yoga has been used in India as a therapeutic method to manage hypertension and other chronic disorders and is fast gaining popularity as an effective means for the alleviation of stress, improvement of fitness, and enhancement of well-being. This study aimed to determine the feasibility of introducing the integrated approach of yoga therapy (IAYT) in a cardiac rehabilitation center in India and understand its usefulness in improving the cardiac function and managing the cardiac risk factors in acute myocardial infarction patients with left ventricular dysfunction. Methods and Design: Cardiac patients were randomized to a yoga-practicing group ( n  = 33) and a control group ( n  = 33). The yoga-practicing group was instructed to attend three supervised IAYT classes 3 days per week for 12 weeks at the hospital yoga center. The control group received standard care that included pharmacologic treatment and the instructions of the cardiologist. The outcome measures were assessed at baseline (T1 = 0) and completion (T2 = 3 months). The primary outcome measure was the left ventricular ejection fraction (LVEF). Results: There was no statistically significant difference in LVEF ( U  = 420.500, p value = 0.218) between the two groups. However, the yoga-practicing group showed significant reduction in depression (Cardiac Depression Scale [CDS], U  = 71, p value = 0.0), anxiety (Hamilton Anxiety Rating Scale [HAM-A], U  = 128, p value = 0.0), and a significant increase in quality of life (QOL) scores (Duke Activity Status Index [DASI], U  = 146, p value = 0.0; and metabolic equivalents (METs), U  = 136, p value = 0.0) at 3 months compared to control. Overall, the CAD patients practicing yoga showed a favorable profile compared to control individuals on CDS, HAM-A, DASI, and MET outcomes. Control and yoga practicing groups did not differ significantly in the lipid levels. Conclusion: This study indicated that the integration of yoga practice in a cardiac rehabilitation program is feasible and has no added benefit in improving the cardiac function. However, the addition of yoga to cardiac rehabilitation may be beneficial in reducing depression and anxiety and improving QOL in patients.",2020,"There was no statistically significant difference in LVEF ( U  = 420.500, p value = 0.218) between the two groups.","['Cardiac Rehabilitation Program', 'acute myocardial infarction patients with left ventricular dysfunction', 'CAD patients']","['Yoga-based lifestyle intervention', 'yoga-practicing group', 'standard care that included pharmacologic treatment and the instructions of the cardiologist', 'yoga therapy (IAYT']","['LVEF', 'CDS, HAM-A, DASI, and MET outcomes', 'quality of life (QOL) scores (Duke Activity Status Index [DASI', 'depression and anxiety and improving QOL', 'cardiac risk factors', 'left ventricular ejection fraction (LVEF', 'triglycerides, dyslipidemia, hyperglycemia, hypertension', 'depression (Cardiac Depression Scale [CDS], U \u2009=\u200971, p value\u2009=\u20090.0), anxiety (Hamilton Anxiety Rating Scale', 'lipid levels']","[{'cui': 'C0150497', 'cui_str': 'Cardiac rehabilitation'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0155626', 'cui_str': 'Acute myocardial infarction'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0242973', 'cui_str': 'Ventricular dysfunction'}, {'cui': 'C0011905', 'cui_str': 'Computer-Assisted Diagnosis'}]","[{'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0031330', 'cui_str': 'Pharmacology'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0175906', 'cui_str': 'Cardiologist'}]","[{'cui': 'C0428772', 'cui_str': 'Left ventricular ejection fraction'}, {'cui': 'C0030481', 'cui_str': 'Human T-cell lymphotropic virus 1-associated myelopathy'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C4720913', 'cui_str': 'Duke activity status index'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0242339', 'cui_str': 'Dyslipidemia'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0428460', 'cui_str': 'Lipid level - finding'}]",,0.0233143,"There was no statistically significant difference in LVEF ( U  = 420.500, p value = 0.218) between the two groups.","[{'ForeName': 'K N Srihari', 'Initials': 'KNS', 'LastName': 'Sharma', 'Affiliation': 'Division of Yoga and Life Sciences, Swami Vivekananda Yoga University (SVYASA), Bangalore, India.'}, {'ForeName': 'Subramanya', 'Initials': 'S', 'LastName': 'Pailoor', 'Affiliation': 'Division of Yoga and Life Sciences, Swami Vivekananda Yoga University (SVYASA), Bangalore, India.'}, {'ForeName': 'Nidhi Ram', 'Initials': 'NR', 'LastName': 'Choudhary', 'Affiliation': 'Division of Yoga and Life Sciences, Swami Vivekananda Yoga University (SVYASA), Bangalore, India.'}, {'ForeName': 'Prabhavathi', 'Initials': 'P', 'LastName': 'Bhat', 'Affiliation': 'Department of Cardiology, Sri Jayadeva Institute of Cardiovascular Sciences and Research, Bangalore, India.'}, {'ForeName': 'Smeeta', 'Initials': 'S', 'LastName': 'Shrestha', 'Affiliation': 'School of Basic and Applied Sciences, Dayananda Sagar University, Bangalore, India.'}]","Journal of alternative and complementary medicine (New York, N.Y.)",['10.1089/acm.2019.0250'] 2514,32609001,Examining Identity Shift Effects in Virtual Reality.,"Identity shift describes how individuals commit to self-presentations made in public computer-mediated contexts. This study attempts to expand identity shift effects to virtual reality. Participants were randomly assigned to present themselves as extraverted or introverted in pilot tested public or private virtual environments. The hypotheses and data analysis strategy were preregistered, and the study had sufficient a priori statistical power. The results did not support identity shift effects. Baseline extraversion predicted postmanipulation extraversion scores, thus suggesting identity stability. The discussion focuses on the empirical consistency of the identity shift effect and avenues for future research.",2020,Participants were randomly assigned to present themselves as extraverted or introverted in pilot tested public or private virtual environments.,[],['extraverted or introverted in pilot tested public or private virtual environments'],[],[],"[{'cui': 'C0557871', 'cui_str': 'Extrovert'}, {'cui': 'C0557869', 'cui_str': 'Introvert'}, {'cui': 'C0473169', 'cui_str': 'Pilot - aircraft'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0033175', 'cui_str': 'Private Room'}, {'cui': 'C0014406', 'cui_str': 'Environment'}]",[],,0.0168884,Participants were randomly assigned to present themselves as extraverted or introverted in pilot tested public or private virtual environments.,"[{'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Peña', 'Affiliation': 'University of California, Davis, Davis, California, USA.'}, {'ForeName': 'Dillon', 'Initials': 'D', 'LastName': 'Hill', 'Affiliation': 'University of California, Davis, Davis, California, USA.'}]","Cyberpsychology, behavior and social networking",['10.1089/cyber.2020.0010'] 2515,32609186,Effects of desensitizing products on the reduction of pain sensitivity caused by in-office tooth bleaching: a 24-week follow-up.,"OBJECTIVE To clinically assess the effect of desensitizing gels and dentifrices on the reduction in pain sensitivity and color variation during tooth bleaching. METHODOLOGY A total of 108 volunteers were randomly separated into the following groups of n=12: GT/S-glycerine and thickener/sucralose; NF/S-potassium nitrate and sodium fluoride/sucralose; NA/S-potassium nitrate and arginine/sucralose; GT/AC-glycerine and thickener/arginine and calcium carbonate; NF/AC-potassium nitrate and sodium fluoride/arginine and calcium carbonate; NA/AC-potassium nitrate and arginine/arginine and calcium carbonate; GT/PN-glycerine and thickener/potassium nitrate; NF/PN-potassium nitrate and sodium fluoride/potassium nitrate; and NA/PN-potassium nitrate and arginine/potassium nitrate. Sensitivity was assessed with the numerical analogue scale, and color variation (ΔE) was measured with a spectrophotometer. The sensitivity values obtained were subjected to a multivariate analysis of variance (MANOVA) and color variation values were subjected to a randomized analysis of variance (p<0.05). RESULTS The NF/AC, NA/AC, NF/PN, and NA/PN groups presented lower sensitivity values and reduced sensitivity compared to those of the other groups throughout the clinical sessions. None of the groups showed sensitivity at the 24-week assessment. Statistically, no significant difference were observed in the color values among the groups four weeks after the beginning of bleaching (p=0.074). Additionally, the color assessment of all groups was statistically similar four weeks (p=0.084) and 24 weeks (p=0.118) after the beginning. CONCLUSION Our results indicate that adding NF/S, NA/S, NF/AC, and NA/AC desensitizers to tooth bleaching protocols reduces pain sensitivity without affecting its effectiveness.",2020,"Additionally, the color assessment of all groups was statistically similar four weeks (p=0.084) and 24 weeks (p=0.118) after the beginning. ",['108 volunteers were randomly separated into the following groups of n=12'],"['desensitizing gels and dentifrices', 'fluoride/sucralose; NA/S-potassium nitrate and arginine/sucralose; GT/AC-glycerine and thickener/arginine and calcium carbonate; NF/AC-potassium nitrate and sodium fluoride/arginine and calcium carbonate; NA/AC-potassium nitrate and arginine/arginine and calcium carbonate; GT/PN-glycerine and thickener/potassium nitrate; NF/PN-potassium nitrate and sodium fluoride/potassium nitrate', 'desensitizing products', 'GT/S-glycerine and thickener/sucralose; NF/S-potassium nitrate and sodium']","['color values', 'numerical analogue scale, and color variation (ΔE', 'sensitivity values and reduced sensitivity', 'pain sensitivity', 'pain sensitivity and color variation', 'Sensitivity']","[{'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0443299', 'cui_str': 'Separate'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0011427', 'cui_str': 'Dentifrice'}, {'cui': 'C0016327', 'cui_str': 'Fluoride'}, {'cui': 'C0077046', 'cui_str': 'sucralose'}, {'cui': 'C0071772', 'cui_str': 'potassium nitrate'}, {'cui': 'C0003765', 'cui_str': 'Arginine'}, {'cui': 'C0017861', 'cui_str': 'Glycerin'}, {'cui': 'C0006681', 'cui_str': 'Calcium Carbonate'}, {'cui': 'C0037508', 'cui_str': 'Sodium Fluoride'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}]","[{'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0042333', 'cui_str': 'Genetic variation'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}]",108.0,0.0167949,"Additionally, the color assessment of all groups was statistically similar four weeks (p=0.084) and 24 weeks (p=0.118) after the beginning. ","[{'ForeName': 'Josué Junior Araujo', 'Initials': 'JJA', 'LastName': 'Pierote', 'Affiliation': 'Universidade Estadual de Campinas, Faculdade de Odontologia de Piracicaba, Departamento de Dentística Restauradora, Piracicaba, Brasil.'}, {'ForeName': 'Lucia Trazzi', 'Initials': 'LT', 'LastName': 'Prieto', 'Affiliation': 'Universidade Estadual de Campinas, Faculdade de Odontologia de Piracicaba, Departamento de Dentística Restauradora, Piracicaba, Brasil.'}, {'ForeName': 'Carlos Tadeu Dos Santos', 'Initials': 'CTDS', 'LastName': 'Dias', 'Affiliation': 'Universidade de São Paulo, Escola Superior de Agricultura Luiz de Queiroz, Departamento de Engenharia Agronômica, Piracicaba, Brasil.'}, {'ForeName': 'João Victor Frazão', 'Initials': 'JVF', 'LastName': 'CÂmara', 'Affiliation': 'Universidade de São Paulo, Faculdade de Odontologia de Bauru, Departamento de Ciências Biológicas, Bauru, Brasil.'}, {'ForeName': 'Débora Alves Nunes Leite', 'Initials': 'DANL', 'LastName': 'Lima', 'Affiliation': 'Universidade Estadual de Campinas, Faculdade de Odontologia de Piracicaba, Departamento de Dentística Restauradora, Piracicaba, Brasil.'}, {'ForeName': 'Flávio Henrique Baggio', 'Initials': 'FHB', 'LastName': 'Aguiar', 'Affiliation': 'Universidade Estadual de Campinas, Faculdade de Odontologia de Piracicaba, Departamento de Dentística Restauradora, Piracicaba, Brasil.'}, {'ForeName': 'Luis Alexandre Maffei Sartini', 'Initials': 'LAMS', 'LastName': 'Paulillo', 'Affiliation': 'Universidade Estadual de Campinas, Faculdade de Odontologia de Piracicaba, Departamento de Dentística Restauradora, Piracicaba, Brasil.'}]",Journal of applied oral science : revista FOB,['10.1590/1678-7757-2019-0755'] 2516,32609230,Effect of CPP-ACP on remineralization of artificial caries-like lesion: an in situ study.,"The purpose of this double-blind, randomized, crossover in situ study is to compare remineralization of preformed enamel lesions by casein phosphopeptide-stabilized amorphous calcium phosphate (CPP-ACP) and fluoride dentifrice products. During each of four 10-day experimental legs, 10 participants wore intraoral removable palatal acrylic appliances with four human enamel slabs with preformed lesions. A 0.03-mL treatment paste was dripped extraorally onto the enamel blocks once a day for 3 min. The four randomly allocated treatments were as follows: CO- Control: silica dentifrice without fluoride; MP: MI Paste; MPP: MI Paste Plus and FD: Fluoride dentifrice - 1100 ppm F as NaF). Knoop surface hardness (SH) test was performed in three stages (T0 - sound enamel, T1 - after preformed lesion, and T2 - after treatment) and the cross-sectional hardness (CSH) test was performed after treatment using a 50-gram Knoop load for 15 s. Knoop hardness number (KHN) was similar between treatments. %SHr was significantly higher in the MP, FD, and MPP when compared to CO group (Kruskal-Wallis and Mann-Whitney tests, p < 0.05). Harder enamel was found in MP (75 μm) and FD groups at 75 to 175 μm. Treatment with DF, MP, and MPP promoted an increase of 20.27%, 19.24%, and 14.71%, respectively, in Integral Hardness Change (ΔIHC) when compared to CO (p<0.05). Remineralizing agents (MP, MPP, and DF) were able to inhibit demineralization of human enamel subjected to high cariogenic challenge in situ. DF had the greatest preventive potential against the progression of carious lesions.",2020,"Remineralizing agents (MP, MPP, and DF) were able to inhibit demineralization of human enamel subjected to high cariogenic challenge in situ.","['artificial caries-like lesion', '10 participants wore intraoral removable palatal acrylic appliances with four human enamel slabs with preformed lesions']","['CPP-ACP', 'Remineralizing agents (MP, MPP, and DF', 'casein phosphopeptide-stabilized amorphous calcium phosphate (CPP-ACP) and fluoride dentifrice products', 'CO', 'FD', 'Fluoride dentifrice - 1100 ppm F as NaF']","['Integral Hardness Change (ΔIHC', 'Knoop surface hardness (SH) test', 'MP, FD, and MPP']","[{'cui': 'C2004457', 'cui_str': 'Artificial'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0442119', 'cui_str': 'Intraoral approach'}, {'cui': 'C0700374', 'cui_str': 'Palatal'}, {'cui': 'C0440181', 'cui_str': 'Acrylic dental material'}, {'cui': 'C1542418', 'cui_str': 'Appliance'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0011350', 'cui_str': 'Enamel structure'}]","[{'cui': 'C1120338', 'cui_str': 'casein phosphopeptide-amorphous calcium phosphate nanocomplex'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0007332', 'cui_str': 'Caseins'}, {'cui': 'C0031684', 'cui_str': 'Phosphopeptides'}, {'cui': 'C0184512', 'cui_str': 'Stabilized'}, {'cui': 'C1956739', 'cui_str': 'amorphous calcium phosphate'}, {'cui': 'C0016327', 'cui_str': 'Fluoride'}, {'cui': 'C0011427', 'cui_str': 'Dentifrice'}, {'cui': 'C4517537', 'cui_str': '1100'}, {'cui': 'C0439187', 'cui_str': 'ppm'}, {'cui': 'C0037508', 'cui_str': 'Sodium Fluoride'}]","[{'cui': 'C0443238', 'cui_str': 'Integral'}, {'cui': 'C0018599', 'cui_str': 'Hard'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0018600', 'cui_str': 'Hardness Tests'}]",10.0,0.0616156,"Remineralizing agents (MP, MPP, and DF) were able to inhibit demineralization of human enamel subjected to high cariogenic challenge in situ.","[{'ForeName': 'Patrícia Regina Almeida de', 'Initials': 'PRA', 'LastName': 'Oliveira', 'Affiliation': 'Universidade Federal Fluminense - UFF, School of Dentistry, Department of Pediatric Dentistry, Niterói, RJ, Brazil.'}, {'ForeName': 'Caroliny Mello', 'Initials': 'CM', 'LastName': 'Barboza', 'Affiliation': 'Universidade Federal Fluminense - UFF, School of Dentistry, Department of Pediatric Dentistry, Niterói, RJ, Brazil.'}, {'ForeName': 'Luísa Schubach da Costa', 'Initials': 'LSDC', 'LastName': 'Barreto', 'Affiliation': 'Universidade Federal Fluminense - UFF, School of Dentistry, Department of Pediatric Dentistry, Niterói, RJ, Brazil.'}, {'ForeName': 'Mônica Almeida', 'Initials': 'MA', 'LastName': 'Tostes', 'Affiliation': 'Universidade Federal Fluminense - UFF, School of Dentistry, Department of Pediatric Dentistry, Niterói, RJ, Brazil.'}]",Brazilian oral research,['10.1590/1807-3107bor-2020.vol34.0061'] 2517,32609294,Association of End Point Definition and Randomized Clinical Trial Duration in Clinical Trials of Schizophrenia Medications.,"Importance Facilitating the development of safe and effective medications for schizophrenia is a public health imperative. Objectives To evaluate the association of shortening randomized clinical trial (RCT) duration with the modification of the Positive and Negative Syndrome Scale (PANSS) for the design of RCTs of medications for schizophrenia and to offer perspective on an alternative regulatory pathway to the historically accepted trial duration and response assessment. Data Sources A database was created consisting of clinical trial data from 32 placebo-controlled RCTs of 8 atypical antipsychotic drugs approved by the US Food and Drug Administration (FDA) between January 1, 2001, and December 31, 2015. The database included information on total and individual PANSS item ratings, demographic characteristics, disposition, and adverse events (AEs). Study Selection All clinical trials submitted to 8 new drug applications of atypical antipsychotic drugs were selected. Data Extraction and Synthesis Quality control checks were performed to ensure that the collected data were consistent with the reported results of each trial. Data were collected from March 15, 2015, to September 30, 2015. Data analysis was conducted from October 1, 2015, to June 20, 2016. Main Outcomes and Measures The following analyses were performed: (1) longitudinal assessment of mean change from baseline in total PANSS score, (2) correlation analyses between change from baseline in total PANSS score at week 6 and earlier time points, (3) concordance analyses of outcomes across trials between week 6 and earlier time points using total PANSS and modified PANSS, and (4) analyses of time course of treatment-emergent AEs. Results The final database contained data from 14 219 participants enrolled in 32 drug trials; 9805 of 14 219 participants (69.0%) were male and were either white (7183 [50.5%]) or black (4346 [30.6%]) individuals. The mean (SD) age during treatment was 38.9 (10.9) years, and the mean (SD) age at schizophrenia diagnosis was 25 (8.5) years. Statistically significant separation between treatment response and placebo response was observed after 1 week of treatment. The overall concordance rate across treatment groups steadily increased from week 1 to week 4 (68.0% for week 1, 74.0% for week 2, 83.0% for week 3, and 93.0% for week 4). Trends in AE occurrence were evident by week 1 and percentage of AEs were similar across weeks 3, 4, and 6. The overall concordance rate between change from baseline in the modified PANSS score and change from baseline in the total PANSS score was 93.0% (80 of 86 treatment groups) at week 4 and 97.7% (84 of 86 treatment groups) at week 6. Shortening the trial duration to 4 weeks increased the required sample size to 502 participants. Using the modified PANSS as the end point, the sample size for a 4-week trial was 402 participants and 296 participants for a 6-week trial. Conclusions and Relevance Findings from this analysis suggest that there is the potential to streamline the design of schizophrenia drug clinical trials. Trial sponsors may consider incorporating these strategies and are encouraged to consult with the FDA early in the drug development process.",2020,"Trends in AE occurrence were evident by week 1 and percentage of AEs were similar across weeks 3, 4, and 6.","['The mean (SD) age during treatment was 38.9 (10.9) years, and the mean (SD) age at schizophrenia diagnosis was 25 (8.5) years', '402 participants and 296 participants for a 6-week trial', '14\u202f219 participants enrolled in 32 drug trials; 9805 of 14 219 participants (69.0%) were male and were either white (7183 [50.5%]) or black (4346 [30.6%]) individuals']",[],"['total and individual PANSS item ratings, demographic characteristics, disposition, and adverse events (AEs', 'overall concordance rate', 'total PANSS score']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C4517877', 'cui_str': '8.5'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C4517648', 'cui_str': '219'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0027361', 'cui_str': 'Person'}]",[],"[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0451383', 'cui_str': 'Positive and negative syndrome scale'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0184758', 'cui_str': 'Patient disposition'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",14219.0,0.0619414,"Trends in AE occurrence were evident by week 1 and percentage of AEs were similar across weeks 3, 4, and 6.","[{'ForeName': 'Islam R', 'Initials': 'IR', 'LastName': 'Younis', 'Affiliation': 'Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Mathangi', 'Initials': 'M', 'LastName': 'Gopalakrishnan', 'Affiliation': 'Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Mitchell', 'Initials': 'M', 'LastName': 'Mathis', 'Affiliation': 'Division of Psychiatry Products, Office of New Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Mehul', 'Initials': 'M', 'LastName': 'Mehta', 'Affiliation': 'Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Ramana', 'Initials': 'R', 'LastName': 'Uppoor', 'Affiliation': 'Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Zhu', 'Affiliation': 'Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland.'}, {'ForeName': 'Tiffany', 'Initials': 'T', 'LastName': 'Farchione', 'Affiliation': 'Division of Psychiatry Products, Office of New Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland.'}]",JAMA psychiatry,['10.1001/jamapsychiatry.2020.1596'] 2518,32609304,Questions on a Randomized Clinical Trial of Stellate Ganglion Block for Patients With Posttraumatic Stress Disorder-Reply.,,2020,,['Patients'],['Stellate Ganglion Block'],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0196728', 'cui_str': 'Injection of anesthetic agent into stellate ganglion'}]",[],,0.0384787,,"[{'ForeName': 'Kristine L', 'Initials': 'KL', 'LastName': 'Rae Olmsted', 'Affiliation': 'RTI International, Research Triangle Park, North Carolina.'}, {'ForeName': 'Bradford B', 'Initials': 'BB', 'LastName': 'Walters', 'Affiliation': 'RTI International, Research Triangle Park, North Carolina.'}, {'ForeName': 'Dennis', 'Initials': 'D', 'LastName': 'Wallace', 'Affiliation': 'RTI International, Research Triangle Park, North Carolina.'}]",JAMA psychiatry,['10.1001/jamapsychiatry.2020.1822'] 2519,32609313,Association of Bempedoic Acid Administration With Atherogenic Lipid Levels in Phase 3 Randomized Clinical Trials of Patients With Hypercholesterolemia.,"Importance Additional lipid-lowering therapy options are needed for patients who cannot achieve sufficient decreases in low-density lipoprotein cholesterol (LDL-C) levels using statins alone or for those who are statin intolerant. Objective To conduct a pooled analysis of phase 3 randomized clinical trials of bempedoic acid vs placebo. Design, Setting, and Participants This analysis pooled data from 4 double-blind, placebo-controlled randomized clinical trials conducted from 2016 to 2018. Patients were enrolled in North America and Europe. Eligibility criteria included hypercholesterolemia while receiving stable lipid-lowering therapy and high cardiovascular risk or hypercholesterolemia and statin intolerance. Interventions Patients were randomized 2:1 to bempedoic acid, 180 mg (n = 2425), or placebo (n = 1198) once daily for 12 to 52 weeks. Main Outcomes and Measures Primary efficacy end point was percentage change from baseline in LDL-C level at week 12 in the intention-to-treat population. Patients were parsed into 2 groups according to enrollment criteria: (1) patients with hypercholesterolemia and atherosclerotic cardiovascular disease (ASCVD) or with heterozygous familial hypercholesterolemia (HeFH) or with both and receiving statins and (2) patients with hypercholesterolemia who were statin intolerant receiving maximally tolerated statins. Results In this analysis of 3623 patients, the overall mean (SD) patient age was 65.5 (9.2) years (similar in both pools). Among patients with ASCVD or HeFH or both, the mean (SD) baseline LDL-C level was 107.6 (32.7) mg/dL. At week 12, the LDL-C level percentage change from baseline was -16.0% with bempedoic acid vs 1.8% with placebo (difference, -17.8%; 95% CI, -19.5% to -16.0%; P < .001). Patients with statin intolerance had a mean (SD) baseline LDL-C level of 144.4 (38.8) mg/dL. The percentage changes in LDL-C levels at week 12 were -23.0% in the bempedoic acid group and 1.5% in the placebo group (difference, -24.5%; 95% CI, -27.8% to -21.1%; P < .001). The decrease in LDL-C levels with bempedoic acid was sustained during long-term follow-up in both pools (patients with ASCVD or HeFH or both receiving a maximally tolerated statin, difference of -12.7% at week 52; patients with statin intolerance, difference of -22.2% at week 24). Decreases in non-high-density lipoprotein cholesterol, total cholesterol, apolipoprotein B, and high-sensitivity C-reactive protein levels were greater with bempedoic acid vs placebo. Treatment-emergent adverse events associated more frequently with bempedoic acid than with placebo included increased blood uric acid level (2.1% vs 0.5%), gout (1.4% vs 0.4%), decreased glomerular filtration rate (0.7% vs <0.1%), and increased levels of hepatic enzymes (2.8% vs 1.3%). Conclusions and Relevance Bempedoic acid added to maximally tolerated statins, including moderate- or high-intensity statins or no background statin, was associated with decreased LDL-C levels vs placebo in patients with hypercholesterolemia with an acceptable safety profile. As a nonstatin adjunct or statin alternative, bempedoic acid has potential for use in a broad spectrum of patients. Trial Registration ClinicalTrials.gov Identifiers: NCT02666664, NCT02991118, NCT03001076, and NCT02988115.",2020,"The decrease in LDL-C levels with bempedoic acid was sustained during long-term follow-up in both pools (patients with ASCVD or HeFH or both receiving a maximally tolerated statin, difference of -12.7% at week 52; patients with statin intolerance, difference of -22.2% at week 24).","['Patients With Hypercholesterolemia', 'patients with hypercholesterolemia', 'Patients were enrolled in North America and Europe', '3623 patients, the overall mean (SD) patient age was 65.5 (9.2) years (similar in both pools', 'Patients were parsed into 2 groups according to enrollment criteria: (1) patients with hypercholesterolemia and atherosclerotic cardiovascular disease (ASCVD) or with heterozygous familial hypercholesterolemia (HeFH) or with both and receiving statins and (2) patients with hypercholesterolemia who were statin intolerant receiving maximally tolerated statins', 'Eligibility criteria included hypercholesterolemia while receiving stable lipid-lowering therapy and high cardiovascular risk or hypercholesterolemia and statin intolerance']","['Bempedoic Acid Administration With Atherogenic Lipid Levels', 'bempedoic acid vs placebo', 'bempedoic acid', 'placebo']","['LDL-C level', 'blood uric acid level', 'low-density lipoprotein cholesterol (LDL-C) levels', 'LDL-C levels', 'non-high-density lipoprotein cholesterol, total cholesterol, apolipoprotein B, and high-sensitivity C-reactive protein levels', 'glomerular filtration rate', 'mean (SD) baseline LDL-C level', 'LDL-C levels with bempedoic acid', 'levels of hepatic enzymes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0020443', 'cui_str': 'Hypercholesterolemia'}, {'cui': 'C0028405', 'cui_str': 'North America'}, {'cui': 'C0015176', 'cui_str': 'Europe'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C5191219', 'cui_str': '9.2'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0337051', 'cui_str': 'Pool'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0004153', 'cui_str': 'Atherosclerosis'}, {'cui': 'C0342882', 'cui_str': 'Familial hypercholesterolemia - heterozygous'}, {'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0585943', 'cui_str': 'Lipid-lowering therapy'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0231199', 'cui_str': 'Intolerance'}]","[{'cui': 'C3659310', 'cui_str': '8-hydroxy-2,2,14,14-tetramethylpentadecanedioic acid'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0428460', 'cui_str': 'Lipid level - finding'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement'}, {'cui': 'C0373739', 'cui_str': 'Blood uric acid'}, {'cui': 'C0023824', 'cui_str': 'LDL cholesterol'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0729627', 'cui_str': 'Non-HDL cholesterol'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0003593', 'cui_str': 'Apolipoprotein B'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C3659310', 'cui_str': '8-hydroxy-2,2,14,14-tetramethylpentadecanedioic acid'}, {'cui': 'C0428321', 'cui_str': 'Measurement of liver enzyme'}]",3623.0,0.428465,"The decrease in LDL-C levels with bempedoic acid was sustained during long-term follow-up in both pools (patients with ASCVD or HeFH or both receiving a maximally tolerated statin, difference of -12.7% at week 52; patients with statin intolerance, difference of -22.2% at week 24).","[{'ForeName': 'Maciej', 'Initials': 'M', 'LastName': 'Banach', 'Affiliation': 'Department of Hypertension, Medical University of Łódź, Łódź, Poland.'}, {'ForeName': 'P Barton', 'Initials': 'PB', 'LastName': 'Duell', 'Affiliation': 'Knight Cardiovascular Institute, School of Medicine, Oregon Health & Science University, Portland.'}, {'ForeName': 'Antonio M', 'Initials': 'AM', 'LastName': 'Gotto', 'Affiliation': 'Cardiovascular Unit, Weill Cornell Medical College, New York, New York.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Laufs', 'Affiliation': 'Clinic and Polyclinic for Cardiology, Leipzig University, Leipzig, Germany.'}, {'ForeName': 'Lawrence A', 'Initials': 'LA', 'LastName': 'Leiter', 'Affiliation': ""Li Ka Shing Knowledge Institute, St Michael's Hospital, University of Toronto, Toronto, Ontario, Canada.""}, {'ForeName': 'G B John', 'Initials': 'GBJ', 'LastName': 'Mancini', 'Affiliation': 'Department of Medicine, Division of Cardiology, University of British Columbia, Vancouver, Canada.'}, {'ForeName': 'Kausik K', 'Initials': 'KK', 'LastName': 'Ray', 'Affiliation': 'Department of Primary Care and Public Health, Imperial College London, London, United Kingdom.'}, {'ForeName': 'JoAnn', 'Initials': 'J', 'LastName': 'Flaim', 'Affiliation': 'Esperion Therapeutics Inc, Ann Arbor, Michigan.'}, {'ForeName': 'Zhan', 'Initials': 'Z', 'LastName': 'Ye', 'Affiliation': 'Esperion Therapeutics Inc, Ann Arbor, Michigan.'}, {'ForeName': 'Alberico L', 'Initials': 'AL', 'LastName': 'Catapano', 'Affiliation': 'Department of Pharmacological and Biomolecular Sciences, University of Milan and IRCCS Multimedica, Milan, Italy.'}]",JAMA cardiology,['10.1001/jamacardio.2020.2314'] 2520,32609319,Questions on a Randomized Clinical Trial of Stellate Ganglion Block for Patients With Posttraumatic Stress Disorder.,,2020,,['Patients With Posttraumatic Stress Disorder'],['Stellate Ganglion Block'],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}]","[{'cui': 'C0196728', 'cui_str': 'Injection of anesthetic agent into stellate ganglion'}]",[],,0.0411613,,"[{'ForeName': 'Murray B', 'Initials': 'MB', 'LastName': 'Stein', 'Affiliation': 'VA San Diego Healthcare System, San Diego, California.'}]",JAMA psychiatry,['10.1001/jamapsychiatry.2020.1815'] 2521,32603336,Short-term effect of osteopathic manual techniques (OMT) on respiratory function in healthy individuals.,"BACKGROUND Respiratory system diseases are some of the most common pathologies worldwide. Although osteopathic manual therapy (OMT) is used predominantly to treat other pathologies, certain OMT techniques have been shown to improve patients' respiratory function. OBJECTIVES The aim of this study was to assess the influence of osteopathic techniques on breathing. METHODS Tests were performed with the use of a spirometer and the results were expressed as Forced Vital Capacity (FVC), Forced Expiratory Volume in 1 second (FEV1), and Peak Expiratory Flow (PEF). Thirty healthy males and females between the age of 18 and 50 took part in the research. Fifteen individuals were randomly assigned to the experimental group and fifteen persons were assigned to the placebo group. The participants from the experimental group were treated with such osteopathic techniques aimed at the pulmonary system as the thoracic thrust (manipulations of vertebral joints and ribs), the sternal pump technique and stretching of the diaphragm. The placebo group was treated with soft tissue therapy (STT) techniques for the masseter muscle. RESULTS The described set of osteopathic techniques exerts an influence on PEF in healthy individuals; however, it does not affect FVC and FEV1. CONCLUSION Osteopathic techniques do not seem to improve lung health, as reflected in FEV1 and FVC, but they improve the respiratory function aspects reflected by PEF in the participants without any history of lung disease.",2020,"Osteopathic techniques do not seem to improve lung health, as reflected in FEV1 and FVC, but they improve the respiratory function aspects reflected by PEF in the participants without any history of lung disease.","['Fifteen individuals', 'Thirty healthy males and females between the age of 18 and 50 took part in the research', 'healthy individuals']","['osteopathic manual therapy (OMT', 'soft tissue therapy (STT) techniques', 'sternal pump technique and stretching of the diaphragm', 'osteopathic manual techniques (OMT', 'placebo']","['Forced Vital Capacity (FVC), Forced Expiratory Volume in 1 second (FEV1), and Peak Expiratory Flow (PEF', 'lung health', 'respiratory function']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}]","[{'cui': 'C0419203', 'cui_str': 'Osteopathy'}, {'cui': 'C0454525', 'cui_str': 'Manual therapy'}, {'cui': 'C3658309', 'cui_str': 'Soft Tissue Therapy'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0270814', 'cui_str': 'Spastic syndrome'}, {'cui': 'C0011980', 'cui_str': 'Diaphragm structure'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0430511', 'cui_str': 'Vital capacity test'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0024109', 'cui_str': 'Lung structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}]",30.0,0.044022,"Osteopathic techniques do not seem to improve lung health, as reflected in FEV1 and FVC, but they improve the respiratory function aspects reflected by PEF in the participants without any history of lung disease.","[{'ForeName': 'Jakub', 'Initials': 'J', 'LastName': 'Stępnik', 'Affiliation': 'Still Academy of Osteopathy, Warsaw, Poland.'}, {'ForeName': 'Agnieszka', 'Initials': 'A', 'LastName': 'Kędra', 'Affiliation': 'Faculty of Physical Education and Health, Józef Pilsudski University of Physical Education in Warsaw, Biała Podlaska, Poland.'}, {'ForeName': 'Dariusz', 'Initials': 'D', 'LastName': 'Czaprowski', 'Affiliation': 'Department of Health Sciences, Physiotherapy Unit, University of Medical Science, Poznań, Poland.'}]",PloS one,['10.1371/journal.pone.0235308'] 2522,32603351,Low-intensity blood flow restriction calf muscle training leads to similar functional and structural adaptations than conventional low-load strength training: A randomized controlled trial.,"The purpose of this study was to investigate whether a six-week, twice weekly resistance training (4 sets at 30% 1-RM until failure) with practical blood flow restriction (BFR) using 7cm wide cuffs with a twist lock placed below the patella is superior to training without BFR (NoBFR) concerning muscle mass and strength gains in calf muscles. A two-group (BFR n = 12, mean age 27.33 (7.0) years, training experience 7.3 (7.0) years; NoBFR n = 9, mean age 28.9 (7.4) years, training experience 7.1 (6.6) years) randomized matched pair design based on initial 1-RM was used to assess the effects on structural and functional adaptations in healthy males (Perometer calf volume [CV], gastrocnemius muscle thickness using ultrasound [MT], 7-maximal hopping test for leg stiffness [LS], 1-RM smith machine calf raise [1-RM], and visual analogue scale as a measure of pain intensity [VAS]). The mean number of repetitions completed per training session across the intervention period was higher in the NoBFR group compared to the BFR group (70 (16) vs. 52 (9), p = 0.002). VAS measured during the first session increased similarly in both groups from first to fourth set (p<0.001). No group effects or time×group interactions were found for CV, MT, LS, and 1-RM. However, there were significant time effects for MT (BFR +0.07 cm; NoBFR +0.04; p = 0.008), and 1-RM (BFR +40 kg; NoBFR +34 kg; p<0.001). LS and CV remained unchanged through training. VAS in both groups were similar, and BFR and NoBFR were equally effective for increasing 1-RM and MT in trained males. However, BFR was more time efficient, due to lesser repetition per training session.",2020,VAS measured during the first session increased similarly in both groups from first to fourth set (p<0.001).,"['A two-group (BFR n = 12, mean age 27.33 (7.0) years, training experience 7.3 (7.0) years; NoBFR n = 9, mean age 28.9 (7.4) years, training experience 7.1 (6.6) years']","['practical blood flow restriction (BFR) using 7cm wide cuffs with a twist lock placed below the patella is superior to training without BFR (NoBFR', 'healthy males (Perometer calf volume [CV], gastrocnemius muscle thickness using ultrasound', 'conventional low-load strength training', 'Low-intensity blood flow restriction calf muscle training']","['CV, MT, LS, and 1-RM', 'VAS', 'LS and CV', '1-RM', '7-maximal hopping test for leg stiffness [LS], 1-RM smith machine calf raise [1-RM], and visual analogue scale as a measure of pain intensity [VAS', 'mean number of repetitions completed per training session']","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C4517858', 'cui_str': '7.4'}, {'cui': 'C4517823', 'cui_str': '6.6'}]","[{'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0332464', 'cui_str': 'Widening'}, {'cui': 'C0441107', 'cui_str': 'Device cuff'}, {'cui': 'C0040480', 'cui_str': 'Torsion'}, {'cui': 'C0442504', 'cui_str': 'Place'}, {'cui': 'C0030647', 'cui_str': 'Bone structure of patella'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0230445', 'cui_str': 'Structure of calf of leg'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0242691', 'cui_str': 'Gastrocnemius muscle structure'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0596836', 'cui_str': 'Light intensity'}, {'cui': 'C0448482', 'cui_str': 'Posterior crural muscle structure'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}, {'cui': 'C0347795', 'cui_str': ""Reversed Colles' fracture""}, {'cui': 'C0336779', 'cui_str': 'Machine'}, {'cui': 'C0230445', 'cui_str': 'Structure of calf of leg'}, {'cui': 'C0442818', 'cui_str': 'Raised'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]",,0.0201696,VAS measured during the first session increased similarly in both groups from first to fourth set (p<0.001).,"[{'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Gavanda', 'Affiliation': 'Department Fitness & Health, IST University of Applied Sciences, Düsseldorf, Germany.'}, {'ForeName': 'Eduard', 'Initials': 'E', 'LastName': 'Isenmann', 'Affiliation': 'Department Fitness & Health, IST University of Applied Sciences, Düsseldorf, Germany.'}, {'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'Schlöder', 'Affiliation': 'Department Fitness & Health, IST University of Applied Sciences, Düsseldorf, Germany.'}, {'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Roth', 'Affiliation': 'Institute of Cardiology and Sports Medicine, German Sport University Cologne, Cologne, Germany.'}, {'ForeName': 'Jürgen', 'Initials': 'J', 'LastName': 'Freiwald', 'Affiliation': 'Department of Sport Science Movement and Training Science, University of Wuppertal, Wuppertal, Germany.'}, {'ForeName': 'Thorsten', 'Initials': 'T', 'LastName': 'Schiffer', 'Affiliation': 'Outpatient Clinic for Sports Traumatology and Public Health Consultation, German Sport University Cologne, Cologne, Germany.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Geisler', 'Affiliation': 'Department Fitness & Health, IST University of Applied Sciences, Düsseldorf, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Behringer', 'Affiliation': 'Institute of Sports Sciences, Goethe-Universität Frankfurt am Main, Frankfurt am Main, Germany.'}]",PloS one,['10.1371/journal.pone.0235377'] 2523,32603357,Shallow-angle needle guide for ultrasound-guided internal jugular venous catheterization: A randomized controlled crossover simulation study (CONSORT).,"BACKGROUND Needle guides for ultrasound-guided internal jugular venous catheterization facilitate successful cannulation. The ability of a needle guide to prevent a posterior vein wall injury which may secondarily induce lethal complications, is unknown. Previous studies showed that a shallow angle of approach may reduce the incidence of posterior wall injuries. We developed a novel needle guide with a shallow angle of approach for ultrasound-guided venous catheterization and examined whether this needle guide reduces the incidence of posterior wall injuries compared to a conventional needle guide and free-hand placement in a simulated vein. METHODS This study was a randomized crossover-controlled trial. The primary outcome was the rate of posterior vein wall injuries. Participants had a didactic lecture about three ultrasound-guided techniques using the short-axis out-of-plane approach, including free-hand (P-free), a commercial needle guide (P-com), and a novel needle guide (P-sha). The view inside a simulated vein was recorded during venipuncture. RESULTS Thirty-five residents participated in this study. Posterior vein wall injuries occurred in 66% using P-free, 60% using P-com, and 0% using P-sha (p< 0.01). There was no significant difference in the incidence of posterior vein wall injuries between P-free and P-com. CONCLUSIONS Use of a shallow angle of approach needle guide resulted in a lower rate of posterior vein injuries during venipuncture of a simulated vein compared with other techniques using a steeper angle techniques.",2020,"CONCLUSIONS Use of a shallow angle of approach needle guide resulted in a lower rate of posterior vein injuries during venipuncture of a simulated vein compared with other techniques using a steeper angle techniques.",['Thirty-five residents participated in this study'],['Shallow-angle needle guide for ultrasound-guided internal jugular venous catheterization'],"['rate of posterior vein wall injuries', 'incidence of posterior vein wall injuries', 'Posterior vein wall injuries', 'rate of posterior vein injuries']","[{'cui': 'C4319605', 'cui_str': '35'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0181951', 'cui_str': 'Needle guide'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0398266', 'cui_str': 'Catheterization of vein'}]","[{'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0226509', 'cui_str': 'Structure of wall of vein'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0340770', 'cui_str': 'Injury of vein'}]",35.0,0.0425578,"CONCLUSIONS Use of a shallow angle of approach needle guide resulted in a lower rate of posterior vein injuries during venipuncture of a simulated vein compared with other techniques using a steeper angle techniques.","[{'ForeName': 'Kunitaro', 'Initials': 'K', 'LastName': 'Watanabe', 'Affiliation': 'Department of Anesthesiology, Kyorin University School of Medicine, Mitaka, Tokyo, Japan.'}, {'ForeName': 'Joho', 'Initials': 'J', 'LastName': 'Tokumine', 'Affiliation': 'Department of Anesthesiology, Kyorin University School of Medicine, Mitaka, Tokyo, Japan.'}, {'ForeName': 'Alan Kawarai', 'Initials': 'AK', 'LastName': 'Lefor', 'Affiliation': 'Department of Surgery, Jichi Medical University, Shimotsuke, Tochigi, Japan.'}, {'ForeName': 'Tomoko', 'Initials': 'T', 'LastName': 'Yorozu', 'Affiliation': 'Department of Anesthesiology, Kyorin University School of Medicine, Mitaka, Tokyo, Japan.'}]",PloS one,['10.1371/journal.pone.0235519'] 2524,32603380,Treatment outcomes of Pumani bubble-CPAP versus oxygen therapy among preterm babies presenting with respiratory distress at a tertiary hospital in Tanzania-Randomised trial.,"BACKGROUND Respiratory distress syndrome (RDS) is the most common respiratory disease in premature babies and the major cause of morbidity and mortality among preterm babies. Effective treatment of these babies requires exogenous surfactant and/or mechanical ventilation but these are of limited availability in low and middle income countries. A cheaper, simpler and more accessible treatment for preterms with RDS called bubble-continuous positive airway pressure (bCPAP) has been reported to be effective in treating RDS in preterm babies with varying levels of effectiveness ranging from 42% to 85%. We aimed to implement and determine the efficacy of bCPAP and its immediate outcomes as compared to oxygen therapy in preterm babies presenting with respiratory distress at a tertiary hospital in Tanzania. METHOD A randomized control trial, conducted from December 2016 to May 2017, included all preterm babies admitted at the neonatal care unit presenting with signs of respiratory distress and meeting the inclusion criteria. The primary outcome was survival while the secondary outcomes were treatment duration, duration of hospital stay and treatment complications. RESULTS A total of 824 babies were admitted in the neonatal care unit during the study period. Of these, 187 babies were preterm and 48 babies were recruited and randomized (25 bCPAP vs 23 oxygen). The overall survival to discharge for all eligible participants (n = 48) was 58.2% compared to those who adhered to treatment protocol (n = 45, 62.2%). Babies in the bCPAP group had higher survival (17/22; 77.3%) as compared to their counterparts in the oxygen therapy group (11/23; 47.8%). Babies treated with bCPAP had 52% lower risk of death (crude HR 0.48, 95% CI = 0.16-1.43) compared to babies receiving oxygen therapy. The median duration of treatment for babies in the oxygen therapy group was 2 (Range 0-16) days compared to 2 (Range 0-5) days in the bCPAP group. The median duration of hospital stay for babies receiving bCPAP was 14 (range 7-43) days. Nasal bleeding was commonly observed among babies in the bCPAP group as compared to those in the oxygen therapy group. CONCLUSION This study revealed that treatment with bCPAP had a 30% clinical improvement in survival to discharge. Our findings highlight the role of bCPAP in reducing neonatal mortality in resource limited settings but further adequately powered studies in this or similar settings are required.",2020,"Babies treated with bCPAP had 52% lower risk of death (crude HR 0.48, 95% CI = 0.16-1.43) compared to babies receiving oxygen therapy.","['conducted from December 2016 to May 2017, included all preterm babies admitted at the neonatal care unit presenting with signs of respiratory distress and meeting the inclusion criteria', 'preterm babies presenting with respiratory distress at a tertiary hospital in Tanzania', '187 babies were preterm and 48 babies', 'Respiratory distress syndrome (RDS', 'preterm babies', 'preterm babies presenting with respiratory distress at a tertiary hospital in Tanzania-Randomised trial', '824 babies were admitted in the neonatal care unit during the study period']","['oxygen therapy', 'bCPAP', 'Pumani bubble-CPAP versus oxygen therapy']","['Nasal bleeding', 'median duration of hospital stay', 'risk of death', 'survival to discharge', 'median duration of treatment for babies', 'treatment duration, duration of hospital stay and treatment complications', 'survival', 'neonatal mortality', 'overall survival to discharge', 'higher survival']","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C4048294', 'cui_str': 'Preterm Infants'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0476273', 'cui_str': 'Respiratory distress'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0039298', 'cui_str': 'Tanzania'}, {'cui': 'C4517618', 'cui_str': '187'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0035220', 'cui_str': 'Respiratory distress syndrome in the newborn'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0184633', 'cui_str': 'Oxygen therapy'}, {'cui': 'C0199451', 'cui_str': 'Continuous positive airway pressure ventilation treatment'}]","[{'cui': 'C0014591', 'cui_str': 'Bleeding from nose'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0444921', 'cui_str': 'Duration of treatment'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0027616', 'cui_str': 'Neonatal Mortality'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205250', 'cui_str': 'High'}]",824.0,0.182245,"Babies treated with bCPAP had 52% lower risk of death (crude HR 0.48, 95% CI = 0.16-1.43) compared to babies receiving oxygen therapy.","[{'ForeName': 'Annette Baine', 'Initials': 'AB', 'LastName': 'Mwatha', 'Affiliation': 'Kilimanjaro Christian Medical University College, Moshi, Tanzania.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Mahande', 'Affiliation': 'Institute of Public Health, Department of Epidemiology & Biostatistics, Kilimanjaro Christian Medical University College (KCMUCo), Moshi, Tanzania.'}, {'ForeName': 'Raimos', 'Initials': 'R', 'LastName': 'Olomi', 'Affiliation': 'Kilimanjaro Christian Medical University College, Moshi, Tanzania.'}, {'ForeName': 'Beatrice', 'Initials': 'B', 'LastName': 'John', 'Affiliation': 'Institute of Public Health, Department of Epidemiology & Biostatistics, Kilimanjaro Christian Medical University College (KCMUCo), Moshi, Tanzania.'}, {'ForeName': 'Rune', 'Initials': 'R', 'LastName': 'Philemon', 'Affiliation': 'Kilimanjaro Christian Medical University College, Moshi, Tanzania.'}]",PloS one,['10.1371/journal.pone.0235031'] 2525,32605396,Physical activity and posttraumatic growth in patients receiving maintenance hemodialysis: A prospective study.,"This study used a prospective design to examine the association between self-reported physical activity and posttraumatic growth (PTG) over a 1-year period among 150 patients receiving maintenance hemodialysis. Transport-related, household, and leisure-time physical activity were positively associated with PTG at baseline and follow-up. Total physical activity could predict higher levels of PTG at follow-up, after controlling for baseline PTG and other covariates. The findings indicate that daily physical activity could be a modifiable behavioral factor associated with PTG among patients receiving maintenance hemodialysis. Further study is needed using a randomized controlled design and objective measures of physical activity.",2020,"Total physical activity could predict higher levels of PTG at follow-up, after controlling for baseline PTG and other covariates.","['patients receiving maintenance hemodialysis', '150 patients receiving maintenance hemodialysis']",['physical activity and posttraumatic growth (PTG'],"['Physical activity and posttraumatic growth', 'Total physical activity', 'Transport-related, household, and leisure-time physical activity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4040576', 'cui_str': 'Maintenance hemodialysis'}, {'cui': 'C4321486', 'cui_str': '150'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C4704809', 'cui_str': 'Posttraumatic Growth'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C4704809', 'cui_str': 'Posttraumatic Growth'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0005528', 'cui_str': 'Biological transport'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0086542', 'cui_str': 'Leisure'}]",150.0,0.0105793,"Total physical activity could predict higher levels of PTG at follow-up, after controlling for baseline PTG and other covariates.","[{'ForeName': 'Jieling', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'The University of Hong Kong, China.'}, {'ForeName': 'Lingling', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Shanghai Chang Zheng Hospital, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Shanghai Chang Zheng Hospital, China.'}, {'ForeName': 'Weijie', 'Initials': 'W', 'LastName': 'Jiang', 'Affiliation': 'Shanghai Shi Bei Hospital, China.'}, {'ForeName': 'Bibo', 'Initials': 'B', 'LastName': 'Wu', 'Affiliation': 'Zha Bei Dsitrict Center Hospital of Shanghai, China.'}, {'ForeName': 'Jingfen', 'Initials': 'J', 'LastName': 'Zhu', 'Affiliation': 'Shanghai Jiao Tong University School of Medicine, China.'}, {'ForeName': 'Vivian Wq', 'Initials': 'VW', 'LastName': 'Lou', 'Affiliation': 'The University of Hong Kong, China.'}, {'ForeName': 'Yaping', 'Initials': 'Y', 'LastName': 'He', 'Affiliation': 'Shanghai Jiao Tong University School of Medicine, China.'}]",Journal of health psychology,['10.1177/1359105320937056'] 2526,32605472,Similar late effects of a 7-week orthodox religious fasting and a time restricted eating pattern on anthropometric and metabolic profiles of overweight adults.,"A hypocaloric diet, based on Orthodox fasting (OF) was followed by 29 overweight adults. A low-calorie, 16/8, time restricted eating (TRE) pattern was followed by 16 age- and weight-matched participants. Anthropometric, lipid, glycaemic and inflammation markers were assessed at baseline, at the end of the intervention (7 weeks from baseline) and 6 weeks after the cessation of diets (13 weeks from baseline). There was a trend of weight loss in both groups, which was evident at week 7 (TRE: -2.1 ± 1.0; OF: -2.0 ± 0.5 kg, p  < 0.001 from baseline) and remained significant at week 13 (TRE: -2.9 ± 0.7; OF: -2.6 ± 0.3 kg, p  < 0.001 from baseline). In the OF group, lipid concentrations declined at week 7 compared with baseline, increasing at week 13 compared with week 7. Our findings suggest that OF promotes a decrease in lipid concentrations, which however, is not evident 6 weeks after its end.",2020,"In the OF group, lipid concentrations declined at week 7 compared with baseline, increasing at week 13 compared with week 7.","['overweight adults', '29 overweight adults']",[],"['weight loss', 'Anthropometric, lipid, glycaemic and inflammation markers', 'lipid concentrations']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]",[],"[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",29.0,0.0697591,"In the OF group, lipid concentrations declined at week 7 compared with baseline, increasing at week 13 compared with week 7.","[{'ForeName': 'Spyridon N', 'Initials': 'SN', 'LastName': 'Karras', 'Affiliation': 'Division of Endocrinology and Metabolism, First Department of Internal Medicine, Medical School, Aristotle University of Thessaloniki, AHEPA University Hospital, Thessaloniki, Greece.'}, {'ForeName': 'Theocharis', 'Initials': 'T', 'LastName': 'Koufakis', 'Affiliation': 'Division of Endocrinology and Metabolism, First Department of Internal Medicine, Medical School, Aristotle University of Thessaloniki, AHEPA University Hospital, Thessaloniki, Greece.'}, {'ForeName': 'Lilian', 'Initials': 'L', 'LastName': 'Adamidou', 'Affiliation': 'Department of Dietetics and Nutrition, AHEPA University Hospital, Thessaloniki, Greece.'}, {'ForeName': 'Stergios A', 'Initials': 'SA', 'LastName': 'Polyzos', 'Affiliation': 'First Laboratory of Pharmacology, School of Medicine, Aristotle University of Thessaloniki, Greece.'}, {'ForeName': 'Paraskevi', 'Initials': 'P', 'LastName': 'Karalazou', 'Affiliation': 'Laboratory of Biological Chemistry, Medical School, Aristotle University of Thessaloniki, AHEPA University Hospital, Thessaloniki, Greece.'}, {'ForeName': 'Katerina', 'Initials': 'K', 'LastName': 'Thisiadou', 'Affiliation': 'Laboratory of Biological Chemistry, Medical School, Aristotle University of Thessaloniki, AHEPA University Hospital, Thessaloniki, Greece.'}, {'ForeName': 'Pantelis', 'Initials': 'P', 'LastName': 'Zebekakis', 'Affiliation': 'Division of Endocrinology and Metabolism, First Department of Internal Medicine, Medical School, Aristotle University of Thessaloniki, AHEPA University Hospital, Thessaloniki, Greece.'}, {'ForeName': 'Kali', 'Initials': 'K', 'LastName': 'Makedou', 'Affiliation': 'Laboratory of Biological Chemistry, Medical School, Aristotle University of Thessaloniki, AHEPA University Hospital, Thessaloniki, Greece.'}, {'ForeName': 'Kalliopi', 'Initials': 'K', 'LastName': 'Kotsa', 'Affiliation': 'Division of Endocrinology and Metabolism, First Department of Internal Medicine, Medical School, Aristotle University of Thessaloniki, AHEPA University Hospital, Thessaloniki, Greece.'}]",International journal of food sciences and nutrition,['10.1080/09637486.2020.1787959'] 2527,31805778,The EMDR Recent Birth Trauma Protocol: a pilot randomised clinical trial after traumatic childbirth.,"Objective: This pilot study investigated the effectiveness of brief EMDR intervention as compared to treatment-as-usual (TAU) in women with post-partum PTSD symptoms. Design: A pilot randomised controlled trial was conducted to evaluate possible differences between one EMDR session ( n  = 19) and one TAU session ( n  = 18) delivered in a maternity ward in the aftermath of childbirth. Main Outcome Measures: The primary outcome measure was the rate of remission of post-partum post-traumatic stress symptoms (i.e. IES-R score <23) in both groups at 6-weeks (T1) and 12-weeks' post-partum (T2). Secondary outcome measures were mother-to-infant bonding, post-partum depressive symptoms, the presence of flashbacks and level of distress. Results: Most of the women improved their post-partum post-traumatic stress symptoms after only one treatment session. EMDR resulted more effective than TAU in reducing the proportion of women with post-partum post-traumatic stress symptoms at 6-weeks' post-partum (78.9% EMDR vs. 39.9% TAU; p = .020). Moreover, women treated with EMDR experienced less flashbacks and distress as compared to TAU. No significant difference was found between treatments on mother-to-infant bonding and post-partum depressive symptoms. Conclusions: These findings, although preliminary, suggest that a brief EMDR intervention could be a viable and promising tool in the early treatment of post-traumatic stress related to traumatic childbirth.",2020,EMDR resulted more effective than TAU in reducing the proportion of women with post-partum post-traumatic stress symptoms at 6-weeks' post-partum (78.9% EMDR vs. 39.9% TAU; ,['women with post-partum PTSD symptoms'],"['EMDR', 'EMDR session ( n \u2009=\u200919) and one TAU session ( n \u2009=\u200918) delivered in a maternity ward in the aftermath of childbirth', 'EMDR intervention', 'TAU']","['rate of remission of post-partum post-traumatic stress symptoms', 'mother-to-infant bonding and post-partum depressive symptoms', 'proportion of women with post-partum post-traumatic stress symptoms', 'flashbacks and distress', 'mother-to-infant bonding, post-partum depressive symptoms, the presence of flashbacks and level of distress']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]","[{'cui': 'C0870535', 'cui_str': 'EMDR'}, {'cui': 'C0281351', 'cui_str': 'uridine triacetate'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C0005615', 'cui_str': 'Birth'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0332663', 'cui_str': 'Traumatic'}, {'cui': 'C0521991', 'cui_str': 'Symptoms of stress'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0236720', 'cui_str': 'Flashbacks'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.191435,EMDR resulted more effective than TAU in reducing the proportion of women with post-partum post-traumatic stress symptoms at 6-weeks' post-partum (78.9% EMDR vs. 39.9% TAU; ,"[{'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Chiorino', 'Affiliation': 'Unit of Perinatal Psychology, Consultorio Familiare Accreditato Genitori Oggi - Mangiagalli, Milan, Italy.'}, {'ForeName': 'Maria Caterina', 'Initials': 'MC', 'LastName': 'Cattaneo', 'Affiliation': 'Unit of Perinatal Psychology, Consultorio Familiare Accreditato Genitori Oggi - Mangiagalli, Milan, Italy.'}, {'ForeName': 'Elena A', 'Initials': 'EA', 'LastName': 'Macchi', 'Affiliation': 'Unit of Perinatal Psychology, Consultorio Familiare Accreditato Genitori Oggi - Mangiagalli, Milan, Italy.'}, {'ForeName': 'Roberta', 'Initials': 'R', 'LastName': 'Salerno', 'Affiliation': 'Unit of Perinatal Psychology, Consultorio Familiare Accreditato Genitori Oggi - Mangiagalli, Milan, Italy.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Roveraro', 'Affiliation': 'Unit of Perinatal Psychology, Consultorio Familiare Accreditato Genitori Oggi - Mangiagalli, Milan, Italy.'}, {'ForeName': 'Giorgia G', 'Initials': 'GG', 'LastName': 'Bertolucci', 'Affiliation': 'Unit of Perinatal Psychology, Consultorio Familiare Accreditato Genitori Oggi - Mangiagalli, Milan, Italy.'}, {'ForeName': 'Fabio', 'Initials': 'F', 'LastName': 'Mosca', 'Affiliation': ""Foundation IRCCS Ca' Granda Ospedale Maggiore Policlinico, NICU, Milan, Italy.""}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Fumagalli', 'Affiliation': ""Foundation IRCCS Ca' Granda Ospedale Maggiore Policlinico, NICU, Milan, Italy.""}, {'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Cortinovis', 'Affiliation': 'Department of Clinical Sciences and Community Health, Laboratory G.A. Maccacaro, University of Milan, Milan, Italy.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Carletto', 'Affiliation': 'Department of Clinical and Biological Sciences, University of Turin, Orbassano, Italy.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Fernandez', 'Affiliation': 'Center of Research and Studies in Psychotraumatology, Milan, Italy.'}]",Psychology & health,['10.1080/08870446.2019.1699088'] 2528,31103640,Role of language control during interbrain phase synchronization of cross-language communication.,"The inhibitory control (IC) model proposes that language control plays an important role in suppressing cross-language interference within a bilingual individual's cross-language output. However, it may also play a role in dynamic interactive communication. Accordingly, the current study used the electroencephalogram (EEG) to simultaneously record neural oscillations from 13 paired unbalanced Chinese-English bilinguals during cooperative picture-naming in either first language (L1) or second language (L2) according to cues. We found that the speaker and listener achieved synchronization by inhibiting interference from the nontarget language (cross-language interference) and partner (interpersonal interference) through language control. Furthermore, the more the language control resources were used, the higher the level of neural synchronization. These findings indicate that language control is associated with neural synchronization of cross-language communication. Altogether, the IC model should highlight the role of language control in inhibiting not only cross-language interference but also interpersonal interference during dynamic cross-language communication.",2019,We found that the speaker and listener achieved synchronization by inhibiting interference from the nontarget language (cross-language interference) and partner (interpersonal interference) through language control.,[],['electroencephalogram (EEG) to simultaneously record neural oscillations from 13 paired unbalanced Chinese-English bilinguals during cooperative picture-naming in either first language (L1) or second language (L2) according to cues'],[],[],"[{'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0376245', 'cui_str': 'English language'}, {'cui': 'C0441468', 'cui_str': 'Photograph'}, {'cui': 'C0557073', 'cui_str': 'First language'}, {'cui': 'C0557074', 'cui_str': 'Second language'}, {'cui': 'C0010439', 'cui_str': 'Cues'}]",[],,0.0161354,We found that the speaker and listener achieved synchronization by inhibiting interference from the nontarget language (cross-language interference) and partner (interpersonal interference) through language control.,"[{'ForeName': 'Huanhuan', 'Initials': 'H', 'LastName': 'Liu', 'Affiliation': 'Research Center of Brain and Cognitive Neuroscience, Liaoning Normal University, Dalian, 116029, China; Beijing Key Laboratory of Applied Experimental Psychology, Faculty of Psychology, Beijing Normal University, Beijing, 100875, China. Electronic address: abcde69503@126.com.'}, {'ForeName': 'Man', 'Initials': 'M', 'LastName': 'Zhang', 'Affiliation': 'Research Center of Brain and Cognitive Neuroscience, Liaoning Normal University, Dalian, 116029, China.'}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Pérez', 'Affiliation': 'Centre for French and Linguistics & Department of Psychology, University of Toronto Scarborough, Toronto, ON, M1C 1A4, Canada.'}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Xie', 'Affiliation': 'Research Center of Brain and Cognitive Neuroscience, Liaoning Normal University, Dalian, 116029, China.'}, {'ForeName': 'Baike', 'Initials': 'B', 'LastName': 'Li', 'Affiliation': 'Research Center of Brain and Cognitive Neuroscience, Liaoning Normal University, Dalian, 116029, China.'}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Liu', 'Affiliation': 'Research Center of Brain and Cognitive Neuroscience, Liaoning Normal University, Dalian, 116029, China.'}]",Neuropsychologia,['10.1016/j.neuropsychologia.2019.05.014'] 2529,31825020,Three-Month Effect of Silver Diamine Fluoride (SDF) in Salivary Levels of Streptococcus Mutans in Children. An Exploratory Trial.,"PURPOSE The aim of this exploratory trial was to compare the 3-month effect of two antimicrobials on the salivary levels of Streptococcus mutans (SM) in children. MATERIALS AND METHODS Ninety school children aged 6-10 years participated. They were divided into two groups according to treatment used: 1% chlorhexidine gel (CHX) or 30% silver diamine fluoride (SDF). Saliva for SM colony forming unit (CFU)/ml counting was harvested in four periods: baseline (prior to antimicrobials); P1 (24 h after antimicrobial therapy); P30 (30 days after antimicrobial therapy); and P90 (90 days after antimicrobial therapy). CFU/ml data was submitted to repeated measures by analysis of variance (ANOVA). RESULTS Only the time factor influenced the results (p <0.001), with a reduction of SM for all evaluated periods in comparison to the baseline. No influence of antimicrobials or interactions of factors were detected (p >0.05). P30 presented the lowest levels of SM and at P90, SM levels were similar to P1 but still lower than the baseline observations. SDF and CHX presented a similar effect on SM within each period of evaluation (p = 0.65). CONCLUSION It was concluded that 30% SDF presents similar antimicrobial effects as 1% CHX over time. SDF might be used as an adjunctive therapy for controlling dental caries in children.",2020,"Only the time factor influenced the results (p <0.001), with a reduction of SM for all evaluated periods in comparison to the baseline.","['Ninety school children aged 6-10 years participated', 'Salivary Levels of Streptococcus Mutans in Children', 'children']","['Silver Diamine Fluoride (SDF', 'chlorhexidine gel (CHX) or 30% silver diamine fluoride (SDF']","['lowest levels of SM and at P90, SM levels', 'antimicrobial effects', 'salivary levels of Streptococcus mutans (SM']","[{'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0260267', 'cui_str': 'School child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0038402', 'cui_str': 'Streptococcus'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0074538', 'cui_str': 'Silver diamine fluoride'}, {'cui': 'C0008196', 'cui_str': 'Chlorhexidine'}, {'cui': 'C0017243', 'cui_str': 'Gel'}]","[{'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0038402', 'cui_str': 'Streptococcus'}, {'cui': 'C0108801', 'cui_str': 'TFRC protein, human'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}]",90.0,0.0577897,"Only the time factor influenced the results (p <0.001), with a reduction of SM for all evaluated periods in comparison to the baseline.","[{'ForeName': 'Marta Diogo', 'Initials': 'MD', 'LastName': 'Garrastazu', 'Affiliation': ''}, {'ForeName': 'Ingrid Fernandes', 'Initials': 'IF', 'LastName': 'Mathias-Santamaria', 'Affiliation': ''}, {'ForeName': 'Rafael Santos', 'Initials': 'RS', 'LastName': 'Rocha', 'Affiliation': ''}, {'ForeName': 'Michele Baffi', 'Initials': 'MB', 'LastName': 'Diniz', 'Affiliation': ''}, {'ForeName': 'Taciana Marco Ferraz', 'Initials': 'TMF', 'LastName': 'Caneppele', 'Affiliation': ''}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Bresciani', 'Affiliation': ''}]",Oral health & preventive dentistry,['10.3290/j.ohpd.a43360'] 2530,32611451,Effectiveness of reminders to sustain practice change among direct care providers in residential care facilities: a cluster randomized controlled trial.,"BACKGROUND The study purpose was to compare the effectiveness of monthly or quarterly peer reminder knowledge translation interventions, with monthly or quarterly paper-based reminders, to sustain a mobility innovation, the sit-to-stand activity. METHOD A cluster RCT using a stratified 2 × 2 factorial design was conducted in 24 Canadian residential care facilities with 416 residents and 54 peer reminder care aides. The 1-year intervention included two intensities of reminders (high: socially based peer reminders delivered by volunteer care aides to other care aides; low: paper-based reminders posted in residents' rooms), at two frequencies (monthly; every 3 months). Intervention fidelity was assessed using questionnaires and observations. Monthly sustainability rate of the sit-to-stand activity was calculated as the percentage of opportunities that residents successfully completed the activity in 30 days. Residents' sustainability rates were analyzed using a linear mixed model that mirrored the clustered repeated-measures factorial trial design. The model included a random intercept to account for clustering within sites. An unstructured covariance structure characterized the interdependence of repeated measures over time. RESULTS Twenty-four sites were randomized. One site was excluded because of falsifying data, leaving 23 sites and 349 residents for intention-to-treat analysis. Paper reminders were implemented with high fidelity across all arms (91.5% per protocol), while the peer reminders were implemented with moderate fidelity in the monthly group (81.0% per protocol) and poor fidelity in the quarterly group (51.7% per protocol). At month 1, mean sustainability ranged from 40.7 to 47.2 per 100 opportunities, across the four intervention arms (p = 0.43). Mean rate of sustainability in the high intensity, high frequency group diverged after randomization, yielding statistically significant differences among the groups at 4 months which persisted for the remainder of the trial. After 12 months, the mean sustainability in the high intensity, high frequency group was approximately twice that of the other three groups combined (64.1 versus 37.8 per 100 opportunities, p < 0.001). CONCLUSIONS A monthly peer reminder intervention was more effective than a quarterly peer reminder intervention, a monthly paper-based reminder intervention, and a quarterly paper-based reminder intervention, in supporting care aides to sustain a mobility innovation in residential care facilities over 1 year. TRIAL REGISTRATION ClinicalTrials.gov , NCT01746459. Registered 11 December 2012: https://clinicaltrials.gov/ct2/show/NCT01746459 .",2020,"After 12 months, the mean sustainability in the high intensity, high frequency group was approximately twice that of the other three groups combined (64.1 versus 37.8 per 100 opportunities, p < 0.001). ","['residential care facilities', 'Twenty-four sites were randomized', '24 Canadian residential care facilities with 416 residents and 54 peer reminder care aides']","[""intensities of reminders (high: socially based peer reminders delivered by volunteer care aides to other care aides; low: paper-based reminders posted in residents' rooms""]","['Monthly sustainability rate of the sit-to-stand activity', 'Mean rate of sustainability', 'Intervention fidelity', 'mean sustainability']","[{'cui': 'C0035186', 'cui_str': 'Residential Facilities'}, {'cui': 'C3715070', 'cui_str': '24'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}]","[{'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0030351', 'cui_str': 'Paper'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}]","[{'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0560801', 'cui_str': 'Does stand from sitting'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]",,0.0687829,"After 12 months, the mean sustainability in the high intensity, high frequency group was approximately twice that of the other three groups combined (64.1 versus 37.8 per 100 opportunities, p < 0.001). ","[{'ForeName': 'Susan E', 'Initials': 'SE', 'LastName': 'Slaughter', 'Affiliation': 'Faculty of Nursing, Edmonton Clinic Health Academy, University of Alberta, 11405 87 Avenue, Edmonton, T6G 1C9, Canada. susan.slaughter@ualberta.ca.'}, {'ForeName': 'Misha', 'Initials': 'M', 'LastName': 'Eliasziw', 'Affiliation': 'Department of Public Health and Community Medicine, Tufts University, Boston, USA.'}, {'ForeName': 'Carla', 'Initials': 'C', 'LastName': 'Ickert', 'Affiliation': 'Faculty of Nursing, Edmonton Clinic Health Academy, University of Alberta, 11405 87 Avenue, Edmonton, T6G 1C9, Canada.'}, {'ForeName': 'C Allyson', 'Initials': 'CA', 'LastName': 'Jones', 'Affiliation': 'Faculty of Rehabilitation Medicine, University of Alberta, Edmonton, Canada.'}, {'ForeName': 'Carole A', 'Initials': 'CA', 'LastName': 'Estabrooks', 'Affiliation': 'Faculty of Nursing, Edmonton Clinic Health Academy, University of Alberta, 11405 87 Avenue, Edmonton, T6G 1C9, Canada.'}, {'ForeName': 'Adrian S', 'Initials': 'AS', 'LastName': 'Wagg', 'Affiliation': 'Faculty of Medicine and Dentistry, University of Alberta, Edmonton, Canada.'}]",Implementation science : IS,['10.1186/s13012-020-01012-z'] 2531,32611505,Treatment Rationale and Design of a Phase III Study of Afatinib or Chemotherapy in Patients with Non-small-cell Lung Cancer Harboring Sensitizing Uncommon Epidermal Growth Factor Receptor Mutations (ACHILLES/TORG1834).,"We describe the treatment rationale and design of our randomized phase III study, the ACHILLES trial (Japan Registry of Clinical Trials: jRCTs031180175). The aim of this study is to investigate the superiority of afatinib over chemotherapy as first-line treatment in patients with advanced nonsquamous non-small-cell lung cancer with sensitizing uncommon or compound epidermal growth factor receptor (EGFR) mutations, with the exception of de novo T790M mutations and exon 20 insertions. Eligible patients will be randomized at a 1:2 ratio to receive either chemotherapy or afatinib until disease progression or unacceptable toxicity. Patients in the chemotherapy arm will receive pemetrexed 500 mg/m 2  + cisplatin 75 mg/m 2 or carboplatin area under the curve (AUC) 5 or 6 every 3 weeks × 4 cycles, followed by pemetrexed 500 mg/m 2 every 3 weeks. In the afatinib arm, investigators will choose the starting dose of afatinib (30 mg or 40 mg orally daily). The primary endpoint is progression-free survival. A total of 106 patients will be enrolled in this trial over a 30-month registration period with a 15-month follow-up. Enrollment began in March 2019. The results of this trial will establish the superiority of afatinib over chemotherapy in a cohort with a large variety of EGFR mutations.",2020,The primary endpoint is progression-free survival.,"['Patients with Non-small-cell Lung Cancer Harboring', 'patients with advanced nonsquamous non-small-cell lung cancer with sensitizing uncommon or compound epidermal growth factor receptor (EGFR) mutations, with the exception of de novo T790M mutations and exon 20 insertions', '106 patients will be enrolled in this trial over a 30-month registration period with a 15-month follow-up', 'Eligible patients']","['afatinib over chemotherapy', 'chemotherapy or afatinib until disease progression or unacceptable toxicity', 'pemetrexed 500 mg/m 2 \xa0+ cisplatin 75 mg/m 2 or carboplatin', 'Afatinib or Chemotherapy']",['progression-free survival'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0475311', 'cui_str': 'Harbor'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0522498', 'cui_str': 'Rare'}, {'cui': 'C0205198', 'cui_str': 'Compound'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C0015295', 'cui_str': 'Exons'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C2987648', 'cui_str': 'Afatinib'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}]","[{'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",106.0,0.101737,The primary endpoint is progression-free survival.,"[{'ForeName': 'Satoru', 'Initials': 'S', 'LastName': 'Miura', 'Affiliation': 'Department of Internal Medicine, Niigata Cancer Center Hospital, Niigata, Japan. Electronic address: miusat1118@niigata-cc.jp.'}, {'ForeName': 'Takeharu', 'Initials': 'T', 'LastName': 'Yamanaka', 'Affiliation': 'Department of Biostatistics, Yokohama City University School of Medicine, Kanagawa, Japan.'}, {'ForeName': 'Terufumi', 'Initials': 'T', 'LastName': 'Kato', 'Affiliation': 'Department of Thoracic Oncology, Kanagawa Cancer Center, Kanagawa, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Ikeda', 'Affiliation': 'Department of Respiratory Medicine, Kanagawa Cardiovascular and Respiratory Center, Kanagawa, Japan.'}, {'ForeName': 'Hidehito', 'Initials': 'H', 'LastName': 'Horinouchi', 'Affiliation': 'Department of Thoracic Oncology, National Cancer Center Hospital, Tokyo, Japan.'}, {'ForeName': 'Eiki', 'Initials': 'E', 'LastName': 'Ichihara', 'Affiliation': 'Department of Allergy and Respiratory Medicine, Okayama University Hospital, Okayama, Japan.'}, {'ForeName': 'Masaki', 'Initials': 'M', 'LastName': 'Kanazu', 'Affiliation': 'Department of Thoracic Oncology, Osaka Toneyama Medical Center, Osaka, Japan.'}, {'ForeName': 'Yuichi', 'Initials': 'Y', 'LastName': 'Takiguchi', 'Affiliation': 'Department of Medical Oncology, Chiba University Hospital, Chiba, Japan.'}, {'ForeName': 'Kentaro', 'Initials': 'K', 'LastName': 'Tanaka', 'Affiliation': 'Department of Respiratory Medicine, Kyusyu University, Fukuoka, Japan.'}, {'ForeName': 'Yasuhiro', 'Initials': 'Y', 'LastName': 'Goto', 'Affiliation': 'Department of Respiratory Medicine, Fujita Health University Hospital, Aichi, Japan.'}, {'ForeName': 'Masafumi', 'Initials': 'M', 'LastName': 'Sata', 'Affiliation': 'Division of Pulmonary Medicine, Department of Internal Medicine, Jichi Medical University, Tochigi, Japan.'}, {'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Hagiwara', 'Affiliation': 'Division of Pulmonary Medicine, Department of Internal Medicine, Jichi Medical University, Tochigi, Japan.'}, {'ForeName': 'Hiroaki', 'Initials': 'H', 'LastName': 'Okamoto', 'Affiliation': ""Department of Respiratory Medicine, Yokohama Municipal Citizen's Hospital, Yokohama, Japan.""}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Tanaka', 'Affiliation': 'Department of Internal Medicine, Niigata Cancer Center Hospital, Niigata, Japan.'}]",Clinical lung cancer,['10.1016/j.cllc.2020.05.011'] 2532,32611602,Effect of opaque wraps for pulse oximeter sensors: randomised cross-over trial.,"BACKGROUND Evidence is lacking as to whether ambient light or phototherapy light could interfere with pulse oximeter performance. METHODS In this randomised cross-over trial, we recruited neonates of gestation >24 weeks. Consented infants were randomly assigned to either pulse oximeter sensor with opaque wrap or without opaque wrap. Nellcor and Masimo sensors were applied simultaneously to different feet for 10 min of recording. Infants were crossed over to the other intervention for a further 10 min, totalling 20 min recording per infant. Primary outcome was faster acquisition of data with shielding of pulse oximeter sensor as compared with not shielding. RESULTS A total of 96 babies were recruited. There was no difference in primary outcome of time taken to display valid data between the two groups (opaque wrap: 12.73±3.1 s vs no opaque wrap: 13.16±3.3 s, p=0.27). There was no difference in any of the secondary outcomes (percentage of valid data points, percentage of time saturation below target, and so on) between the two groups in both pulse oximeters. Masimo sensor readings displayed a higher mean oxygen saturation (mean difference of 2.85, p=0.001) and lower percentage of time saturation below 94% (mean difference of -27.8, p=0.001) than Nellcor in both groups. There was no difference in any of the outcomes in babies receiving phototherapy (n=21). CONCLUSION In this study, shielding the pulse oximeter sensor from ambient light or phototherapy light did not yield faster data acquisition or better data quality. TRIAL REGISTRATION NUMBER ISRCTN10302534.",2020,"Masimo sensor readings displayed a higher mean oxygen saturation (mean difference of 2.85, p=0.001) and lower percentage of time saturation below 94% (mean difference of -27.8, p=0.001) than Nellcor in both groups.","['recruited neonates of gestation >24 weeks', 'babies receiving phototherapy (n=21', 'A total of 96 babies were recruited']","['opaque wraps', 'pulse oximeter sensor with opaque wrap or without opaque wrap']","['time saturation', 'mean oxygen saturation', 'time taken to display valid data', 'faster acquisition of data with shielding of pulse oximeter sensor as compared with not shielding']","[{'cui': 'C0003065', 'cui_str': 'Animals, Neonatal'}, {'cui': 'C0730523', 'cui_str': 'Gestation greater than 24 weeks'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0031765', 'cui_str': 'Light therapy'}, {'cui': 'C0439810', 'cui_str': 'Total'}]","[{'cui': 'C0029053', 'cui_str': 'Decreased translucency'}, {'cui': 'C0182109', 'cui_str': 'Pulse oximeter'}, {'cui': 'C0183210', 'cui_str': 'Sensor device'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0522534', 'cui_str': 'Saturated'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0182109', 'cui_str': 'Pulse oximeter'}, {'cui': 'C0183210', 'cui_str': 'Sensor device'}, {'cui': 'C0183251', 'cui_str': 'Shield'}]",96.0,0.199436,"Masimo sensor readings displayed a higher mean oxygen saturation (mean difference of 2.85, p=0.001) and lower percentage of time saturation below 94% (mean difference of -27.8, p=0.001) than Nellcor in both groups.","[{'ForeName': 'Prakash', 'Initials': 'P', 'LastName': 'Kannan Loganathan', 'Affiliation': 'Neonatal Intensive Care Unit, James Cook University Hospital, Middlesbrough, UK pkannanloganathan@nhs.net.'}, {'ForeName': 'Joyce E', 'Initials': 'JE', 'LastName': ""O'Shea"", 'Affiliation': 'Neonatal Intensive Care Unit, Royal Hospital for Children, Glasgow, United Kingdom.'}, {'ForeName': 'Chidambara', 'Initials': 'C', 'LastName': 'Harikumar', 'Affiliation': 'Neonatal Intensive Care Unit, University Hospital of North Tees, Stockton on Tees, United Kingdom.'}, {'ForeName': 'John C', 'Initials': 'JC', 'LastName': 'Brigham', 'Affiliation': 'Department of Engineering, University of Durham, Durham, United Kingdom.'}, {'ForeName': 'Yacov', 'Initials': 'Y', 'LastName': 'Rabi', 'Affiliation': 'Department of Pediatrics, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Samir', 'Initials': 'S', 'LastName': 'Gupta', 'Affiliation': 'Neonatal Intensive Care Unit, University Hospital of North Tees, Stockton on Tees, United Kingdom.'}]",Archives of disease in childhood. Fetal and neonatal edition,['10.1136/archdischild-2020-319049'] 2533,32603632,Internet-based cognitive behavioural therapy for depression and anxiety among Arabic-speaking individuals in Sweden: a pilot randomized controlled trial.,"Arabic-speaking immigrants and refugees constitute one of the largest immigrant groups in Sweden. Previous research on Arabic-speaking immigrants indicates elevated levels of psychological disorders, including depression and anxiety. The aim of the present pilot study was to examine the efficacy of an internet-delivered cognitive behavioural treatment (ICBT) in an Arabic-speaking immigrant population. The intervention was individually tailored based on self-described problems and consisted of nine modules targeting areas such as depression, anxiety and insomnia. In total, 59 individuals were included and randomized to either an 8-week treatment or wait-list control. Self-reported symptoms of depression on the PHQ-9 were used as primary outcome measure. Secondary outcome measures of anxiety, stress, insomnia, quality of life and post-traumatic stress were also used. In the intention-to-treat analysis, depressive symptoms were significantly reduced compared to the wait-list control group with a between-group effect at post-treatment of Cohen's d = 0.85 [0.29, 1.41]. We also found significant between-group effects for symptoms of insomnia and stress, but not for anxiety, post-traumatic stress or quality of life measures. The results indicate that ICBT is a promising treatment approach for treating symptoms of depression, insomnia and stress, in an Arabic-speaking immigrant population. Further studies with larger samples are warranted.",2020,"In the intention-to-treat analysis, depressive symptoms were significantly reduced compared to the wait-list control group with a between-group effect at post-treatment of Cohen's d = 0.85","['59 individuals', 'Arabic-speaking individuals in Sweden', 'Arabic-speaking immigrants and refugees constitute one of the largest immigrant groups in Sweden', 'Arabic-speaking immigrant population']","['internet-delivered cognitive behavioural treatment (ICBT', 'wait-list control', 'ICBT', 'Internet-based cognitive behavioural therapy']","['anxiety, stress, insomnia, quality of life and post-traumatic stress', 'anxiety, post-traumatic stress or quality of life measures', 'symptoms of insomnia and stress', 'depressive symptoms']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0574175', 'cui_str': 'Arabic language'}, {'cui': 'C0234856', 'cui_str': 'Speaking'}, {'cui': 'C0038995', 'cui_str': 'Sweden'}, {'cui': 'C0282163', 'cui_str': 'Immigrant'}, {'cui': 'C0034961', 'cui_str': 'Refugee'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0332663', 'cui_str': 'Traumatic'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]",59.0,0.0499904,"In the intention-to-treat analysis, depressive symptoms were significantly reduced compared to the wait-list control group with a between-group effect at post-treatment of Cohen's d = 0.85","[{'ForeName': 'Tomas', 'Initials': 'T', 'LastName': 'Lindegaard', 'Affiliation': 'Department of Behavioural Sciences and Learning, Linköping University , Linköping, Sweden.'}, {'ForeName': 'Felicia', 'Initials': 'F', 'LastName': 'Seaton', 'Affiliation': 'Department of Behavioural Sciences and Learning, Linköping University , Linköping, Sweden.'}, {'ForeName': 'Asala', 'Initials': 'A', 'LastName': 'Halaj', 'Affiliation': 'Department of Psychology, The Hebrew University of Jerusalem , Jerusalem, Israel.'}, {'ForeName': 'Matilda', 'Initials': 'M', 'LastName': 'Berg', 'Affiliation': 'Department of Behavioural Sciences and Learning, Linköping University , Linköping, Sweden.'}, {'ForeName': 'Fatima', 'Initials': 'F', 'LastName': 'Kashoush', 'Affiliation': 'Department of Behavioural Sciences and Learning, Linköping University , Linköping, Sweden.'}, {'ForeName': 'Rim', 'Initials': 'R', 'LastName': 'Barchini', 'Affiliation': 'Region Östergötland , Motala, Sweden.'}, {'ForeName': 'Mikael', 'Initials': 'M', 'LastName': 'Ludvigsson', 'Affiliation': 'Department of Psychiatry in Linköping, and Department of Biomedical and Clinical Sciences, Linköping University , Linköping, Sweden.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Sarkohi', 'Affiliation': 'Department of Behavioural Sciences and Learning, Linköping University , Linköping, Sweden.'}, {'ForeName': 'Gerhard', 'Initials': 'G', 'LastName': 'Andersson', 'Affiliation': 'Department of Behavioural Sciences and Learning, Linköping University , Linköping, Sweden.'}]",Cognitive behaviour therapy,['10.1080/16506073.2020.1771414'] 2534,32603714,Deterioration of Nighttime Respiratory Mechanics in Chronic Obstructive Pulmonary Disease: Impact of Bronchodilator Therapy.,"BACKGROUND Chronic Obstructive Pulmonary Disease (COPD) is associated with nighttime respiratory symptoms, poor sleep quality, and increased risk of nocturnal mortality. Overnight deterioration of inspiratory capacity (IC) and forced expiratory volume in 1 second (FEV 1 ) have previously been documented. However, the precise nature of this deterioration and mechanisms by which evening bronchodilators may mitigate this have not been studied. RESEARCH QUESTION To determine the effect of evening dosing of dual, long-acting bronchodilators on detailed nocturnal respiratory mechanics and inspiratory neural drive (IND). STUDY DESIGN A double-blind, randomized, placebo-controlled crossover study assessed the effects of evening long-acting bronchodilators (BD; aclidinium bromide/formoterol fumarate dihydrate, 400/12 mcg) or placebo (PL) on morning trough IC (12 hours post-dose; primary outcome) and serial overnight measurements of spirometry, dynamic respiratory mechanics and IND (secondary outcomes). METHODS 20 participants with COPD (moderate/severe airway obstruction and lung hyperinflation) underwent serial measurements of IC, spirometry, breathing pattern, esophageal and transdiaphragmatic pressures and diaphragm electromyography (EMGdi %max ; IND) at 6 time points from 20h00-08h00 (i.e. 0-12 hours post-dose) and compared with sleeping IND. RESULTS Compared with PL, evening BD was not associated with increased morning trough IC 12 hours post-dose (p=0.48); however, nadir IC (lowest IC, independent of time), peak IC, area under the curve for 12 hours post-dose (AUC 0-12), and IC for 10 hours post-dose were improved (p<0.05). During PL, total airways resistance, lung hyperinflation, IND, and tidal esophageal and transdiaphragmatic pressure swings all increased significantly overnight compared with baseline evening values; however, each of these parameters improved with BD treatment (p<0.05) with no change in ventilation or breathing pattern. INTERPRETATION Respiratory mechanics significantly deteriorated at night during PL. While morning trough IC was unchanged, evening bronchodilator treatment was consistently associated with sustained overnight improvements in dynamic respiratory mechanics and inspiratory neural drive compared with placebo.",2020,"While morning trough IC was unchanged, evening bronchodilator treatment was consistently associated with sustained overnight improvements in dynamic respiratory mechanics and inspiratory neural drive compared with placebo.","['Chronic Obstructive Pulmonary Disease (COPD', '20 participants with COPD (moderate/severe airway obstruction and lung hyperinflation', 'Chronic Obstructive Pulmonary Disease']","['evening long-acting bronchodilators (BD; aclidinium bromide/formoterol fumarate dihydrate', 'placebo (PL', 'dual, long-acting bronchodilators', 'placebo']","['serial overnight measurements of spirometry, dynamic respiratory mechanics and IND (secondary outcomes', 'dynamic respiratory mechanics and inspiratory neural drive', 'morning trough IC', 'Overnight deterioration of inspiratory capacity (IC) and forced expiratory volume', 'nadir IC (lowest IC, independent of time), peak IC, area under the curve', 'IC, spirometry, breathing pattern, esophageal and transdiaphragmatic pressures and diaphragm electromyography (EMGdi %max ; IND', 'total airways resistance, lung hyperinflation, IND, and tidal esophageal and transdiaphragmatic pressure swings', 'detailed nocturnal respiratory mechanics and inspiratory neural drive (IND']","[{'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0001883', 'cui_str': 'Respiratory obstruction'}, {'cui': 'C1167782', 'cui_str': 'Lung hyperinflation'}]","[{'cui': 'C0587117', 'cui_str': 'Evening'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0006280', 'cui_str': 'Bronchodilator agent'}, {'cui': 'C2699758', 'cui_str': 'aclidinium bromide'}, {'cui': 'C1579393', 'cui_str': 'Formoterol fumarate dihydrate'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0205173', 'cui_str': 'Double'}]","[{'cui': 'C0031082', 'cui_str': 'Periodicals'}, {'cui': 'C0439583', 'cui_str': 'Overnight'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0037981', 'cui_str': 'Spirometry'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0035230', 'cui_str': 'Breathing Mechanics'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332170', 'cui_str': 'Morning'}, {'cui': 'C0444506', 'cui_str': 'Trough'}, {'cui': 'C0021610', 'cui_str': 'Inspiratory capacity'}, {'cui': 'C0016529', 'cui_str': 'Forced expired volume'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0332291', 'cui_str': 'Independent of'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0205504', 'cui_str': 'Transdiaphragmatic approach'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0011980', 'cui_str': 'Diaphragm structure'}, {'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C0127092', 'cui_str': 'Max protein'}, {'cui': 'C0232024', 'cui_str': 'Total airway resistance'}, {'cui': 'C1167782', 'cui_str': 'Lung hyperinflation'}, {'cui': 'C0240526', 'cui_str': 'Night time'}]",20.0,0.596271,"While morning trough IC was unchanged, evening bronchodilator treatment was consistently associated with sustained overnight improvements in dynamic respiratory mechanics and inspiratory neural drive compared with placebo.","[{'ForeName': 'Nicolle J', 'Initials': 'NJ', 'LastName': 'Domnik', 'Affiliation': ""Department of Medicine, Queen's University, Kingston, Canada.""}, {'ForeName': 'Matthew D', 'Initials': 'MD', 'LastName': 'James', 'Affiliation': ""Department of Medicine, Queen's University, Kingston, Canada.""}, {'ForeName': 'Robin E', 'Initials': 'RE', 'LastName': 'Scheeren', 'Affiliation': ""Department of Medicine, Queen's University, Kingston, Canada.""}, {'ForeName': 'Grace A', 'Initials': 'GA', 'LastName': 'Ayoo', 'Affiliation': ""Department of Medicine, Queen's University, Kingston, Canada.""}, {'ForeName': 'Sarah M', 'Initials': 'SM', 'LastName': 'Taylor', 'Affiliation': ""Department of Medicine, Queen's University, Kingston, Canada.""}, {'ForeName': 'Amanda T', 'Initials': 'AT', 'LastName': 'Di Luch', 'Affiliation': ""Department of Medicine, Queen's University, Kingston, Canada.""}, {'ForeName': 'Kathryn M', 'Initials': 'KM', 'LastName': 'Milne', 'Affiliation': ""Department of Medicine, Queen's University, Kingston, Canada.""}, {'ForeName': 'Sandra G', 'Initials': 'SG', 'LastName': 'Vincent', 'Affiliation': ""Department of Medicine, Queen's University, Kingston, Canada.""}, {'ForeName': 'Devin B', 'Initials': 'DB', 'LastName': 'Phillips', 'Affiliation': ""Department of Medicine, Queen's University, Kingston, Canada.""}, {'ForeName': 'Amany F', 'Initials': 'AF', 'LastName': 'Elbehairy', 'Affiliation': ""Department of Medicine, Queen's University, Kingston, Canada; Department of Chest Diseases, Faculty of Medicine, Alexandria University, Alexandria, Egypt.""}, {'ForeName': 'Sophie J', 'Initials': 'SJ', 'LastName': 'Crinion', 'Affiliation': ""Department of Medicine, Queen's University, Kingston, Canada; Sleep Disorders Laboratory, Kingston Health Sciences Centre, Kingston, Canada; Division of Respiratory Medicine, Queen's University, Kingston, Canada.""}, {'ForeName': 'Helen S', 'Initials': 'HS', 'LastName': 'Driver', 'Affiliation': ""Department of Medicine, Queen's University, Kingston, Canada; Sleep Disorders Laboratory, Kingston Health Sciences Centre, Kingston, Canada; Division of Respiratory Medicine, Queen's University, Kingston, Canada.""}, {'ForeName': 'J Alberto', 'Initials': 'JA', 'LastName': 'Neder', 'Affiliation': ""Department of Medicine, Queen's University, Kingston, Canada; Division of Respiratory Medicine, Queen's University, Kingston, Canada.""}, {'ForeName': 'Denis E', 'Initials': 'DE', 'LastName': ""O'Donnell"", 'Affiliation': ""Department of Medicine, Queen's University, Kingston, Canada; Division of Respiratory Medicine, Queen's University, Kingston, Canada. Electronic address: odonnell@queensu.ca.""}]",Chest,['10.1016/j.chest.2020.06.033'] 2535,32603753,Physical fitness and activity changes after a 24-week soccer-based adaptation of the U.S diabetes prevention program intervention in Hispanic men.,"PURPOSE One third of the U.S. adult population is estimated to have prediabetes. Hispanics have a 50% higher type 2 diabetes (T2DM) death rate compared to non-Hispanic whites, yet low participation in lifestyle change programs, making this subgroup an important target for prevention efforts. The purpose of this study was to determine the effects of an exercise intervention implementing the Center for Disease Control and Prevention National Diabetes Prevention Program (NDPP) plus recreational soccer (RS) in Hispanic men. METHODS Overweight and obese Hispanic men, aged 30-57 years with prediabetes at screening were recruited from the community. Trained soccer coaches led 30-min facilitated discussion of the NDPP modules after each RS session, with two weekly sessions delivered over 12 wks, then once a wk until 24 wks. The 1-h RS sessions followed the Football Fitness curriculum structure. Standardized study assessments included objectively measured physical activity via fitness tracker, physical fitness via validated field tests, global positional system soccer specific metrics and behavior change questionnaires. Mixed models assessed the outcomes as a function of time and cohort and incorporated an unstructured covariance structure to examine the difference between baseline, 12 and 24 wks. All analyses were conducted as intent-to-treat and generated using SAS v 9.4. RESULTS Hispanic males (n = 41; mean age 41.9 [6.2 SD] years) were obese at baseline (mean BMI 32.7, standard error [0.7]). After 24 wks of the NDPP+RS intervention, there were significant beneficial changes in vertical jump (2.8 [1.3] cm; p = 0.048), agility and lower extremity muscular power (figure 8-run) at 12 wks (-4.7% change; p = 0.001) and 24 wks (-7.2% change; p < 0.0001), predicted VO 2 max (12 wks: 1.9%; p = 0.007; 24 wks 1.0%; p = 0.036), modified push-ups increased 22% (p < 0.0001) at 12 wks and 31% (p < 0.0001) at 24 wks, dynamic sit-ups increased 10% (p = 0.005) at 12 wks and 15% (p < 0.0001) at 24 wks. CONCLUSION Among middle-aged Latino men, broad-ranging significant improvements in physical fitness were observed after 24 wks participating in lifestyle education plus RS in a single arm feasibility trial.",2020,"Hispanics have a 50% higher type 2 diabetes (T2DM) death rate compared to non-Hispanic whites, yet low participation in lifestyle change programs, making this subgroup an important target for prevention efforts.","['Hispanic men', 'Overweight and obese Hispanic men, aged 30-57\u202fyears with prediabetes at screening were recruited from the community', 'Hispanic males (n\u202f=\u202f41; mean age 41.9 [6.2 SD] years) were obese at baseline (mean BMI 32.7, standard error [0.7', 'Trained soccer coaches', 'middle-aged Latino men']","['U.S diabetes prevention program intervention', 'exercise intervention implementing the Center for Disease Control and Prevention National Diabetes Prevention Program (NDPP) plus recreational soccer (RS']","['type 2 diabetes (T2DM) death rate', 'agility and lower extremity muscular power', 'dynamic sit-ups', 'physical activity via fitness tracker, physical fitness via validated field tests, global positional system soccer specific metrics and behavior change questionnaires', 'physical fitness', 'modified push-ups', 'beneficial changes in vertical jump', 'Physical fitness and activity changes']","[{'cui': 'C0086409', 'cui_str': 'Hispanic'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0271650', 'cui_str': 'Impaired glucose tolerance'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517820', 'cui_str': '6.2'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C4517474', 'cui_str': '0.7'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0037393', 'cui_str': 'Soccer'}, {'cui': 'C0557773', 'cui_str': 'Coach'}, {'cui': 'C0205847', 'cui_str': 'Middle aged'}, {'cui': 'C0086528', 'cui_str': 'Latinos'}]","[{'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C0007670', 'cui_str': 'Centers for Disease Control and Prevention (U.S.)'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0037393', 'cui_str': 'Soccer'}]","[{'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0442025', 'cui_str': 'Muscular'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0560837', 'cui_str': 'Does sit up'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C3856555', 'cui_str': 'Fitness Trackers'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0440042', 'cui_str': ""Field's stain""}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0037393', 'cui_str': 'Soccer'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0699680', 'cui_str': 'Metric'}, {'cui': 'C0542299', 'cui_str': 'Change in behavior'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0580841', 'cui_str': 'Does push'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",,0.0285683,"Hispanics have a 50% higher type 2 diabetes (T2DM) death rate compared to non-Hispanic whites, yet low participation in lifestyle change programs, making this subgroup an important target for prevention efforts.","[{'ForeName': 'Jennifer K', 'Initials': 'JK', 'LastName': 'Frediani', 'Affiliation': 'Nell Hodgson Woodruff School of Nursing, Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Alan F', 'Initials': 'AF', 'LastName': 'Bienvenida', 'Affiliation': 'Rollins School of Public Health, Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Jianheng', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Rollins School of Public Health, Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Melinda K', 'Initials': 'MK', 'LastName': 'Higgins', 'Affiliation': 'Nell Hodgson Woodruff School of Nursing, Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Felipe', 'Initials': 'F', 'LastName': 'Lobelo', 'Affiliation': 'Rollins School of Public Health, Emory University, Atlanta, GA, USA. Electronic address: felipelobelo@emory.edu.'}]",Progress in cardiovascular diseases,['10.1016/j.pcad.2020.06.012'] 2536,32605492,Nurse-led Care Program with Patients with Heart Failure Using Johnson's Behavioral System Model: A Randomized Controlled Trial.,"Patients with heart failure experience system imbalance and have multiple symptoms. A nurse-led care program based on Johnson's behavioral system model was used to improve the balance of the behavioral system of heart failure patients. One hundred and fifty patients were randomly assigned into two groups. In the experimental group, the patient's status was evaluated by a behavioral subsystem assessment tool related to the level of imbalance. The patients in the intervention group received care individually based on their worst subsystem scores over a period of 2 weeks. The results showed significant improvement in restorative, ingestive, eliminative, aggressive/protective, dependency, and achievement ( p < .05) subsystems in the experimental group. However, no significant difference was seen in sexual and affiliative ( p > .05) subsystems.",2020,"The results showed significant improvement in restorative, ingestive, eliminative, aggressive/protective, dependency, and achievement ( p < .05) subsystems in the experimental group.","['heart failure patients', 'Patients with Heart Failure', 'One hundred and fifty patients', 'Patients with heart failure experience system imbalance and have multiple symptoms']","['Nurse-led Care Program', ""Johnson's Behavioral System Model""]","['restorative, ingestive, eliminative, aggressive/protective, dependency, and achievement', 'sexual and affiliative']","[{'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0231217', 'cui_str': 'Multiple symptoms'}]","[{'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}]","[{'cui': 'C0001807', 'cui_str': 'Aggressive behavior'}, {'cui': 'C0011546', 'cui_str': 'Dependency, Psychology'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C0036864', 'cui_str': 'Sexual behavior'}]",150.0,0.0158106,"The results showed significant improvement in restorative, ingestive, eliminative, aggressive/protective, dependency, and achievement ( p < .05) subsystems in the experimental group.","[{'ForeName': 'Behnoush', 'Initials': 'B', 'LastName': 'Rahmani', 'Affiliation': 'MSc Student, Department of Medical-Surgical Nursing, School of Nursing and Midwifery, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Nahid', 'Initials': 'N', 'LastName': 'Aghebati', 'Affiliation': 'Assistant professor, Nursing and Midwifery Care Research Center, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Habibollah', 'Initials': 'H', 'LastName': 'Esmaily', 'Affiliation': 'Professor, Department of Biostatistics and Epidemiology, Social Determinants of Health.'}, {'ForeName': 'Kristine L', 'Initials': 'KL', 'LastName': 'Florczak', 'Affiliation': 'Assistant Professor, Purdue University Northwest, Calumet, IN, USA.'}]",Nursing science quarterly,['10.1177/0894318420932102'] 2537,32605501,Randomised controlled trial of 1% and 5% 5-fluorouracil creams compared with 90% trichloroacetic acid solution for anogenital wart treatment.,"To evaluate the efficacy and safety of 1% and 5% 5-fluorouracil (5-FU) creams compared with 90% trichloroacetic acid (TCA) for the treatment of anogenital warts. we conducted a randomised controlled study in 72 subjects allocated to three groups: 1% 5-FU, 90% TCA and 5% 5-FU; 90% TCA was administered once a week, whereas 5-FU cream was applied three times a week. Response to therapy and side-effects were evaluated weekly for seven weeks. Evaluation at week 7 demonstrated that there was no significant difference in the efficacy between 1% 5-FU cream and 90% TCA ( p  =   0.763) or between 5% 5-FU cream and 90% TCA ( p  =   0.274). Subjective side-effects with 1% 5-FU were significantly milder than 90% TCA; however, significantly milder objective side-effects were observed only at weeks 2, 6 and 7. The subjective side-effects with 5% 5-FU were also significantly milder than 90% TCA; however, significantly milder objective side-effects were observed only at week 2. 5-FU may become an alternative topical therapy as it offers the benefit of self-application; furthermore, a concentration of 1% 5-FU cream is recommended due to milder side-effects.",2020,Evaluation at week 7 demonstrated that there was no significant difference in the efficacy between 1% 5-FU cream and 90% TCA ( p  =   0.763) or between 5% 5-FU cream and 90% TCA ( p  =   0.274).,"['anogenital warts', '72 subjects allocated to three groups: 1']","['trichloroacetic acid (TCA', '5-FU cream', 'TCA', '90% trichloroacetic acid solution', '5-FU, 90% TCA and 5% 5-FU', '5-fluorouracil (5-FU) creams', '5-fluorouracil creams', '5-FU']","['Subjective side-effects', 'subjective side-effects', 'efficacy and safety', 'efficacy', 'milder objective side-effects']","[{'cui': 'C0009663', 'cui_str': 'Genital warts'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0040900', 'cui_str': 'Trichloroacetic acid'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0700385', 'cui_str': 'Cream'}, {'cui': 'C0037633', 'cui_str': 'Solution'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0018017', 'cui_str': 'Goal'}]",,0.0163803,Evaluation at week 7 demonstrated that there was no significant difference in the efficacy between 1% 5-FU cream and 90% TCA ( p  =   0.763) or between 5% 5-FU cream and 90% TCA ( p  =   0.274).,"[{'ForeName': 'Ika', 'Initials': 'I', 'LastName': 'Anggraini', 'Affiliation': 'Department of Dermatology and Venereology, Faculty of Medicine Universitas Indonesia-Cipto Mangunkusumo National General Hospital, Jakarta, Indonesia.'}, {'ForeName': 'Aida Sd', 'Initials': 'AS', 'LastName': 'Hoemardani', 'Affiliation': 'Department of Dermatology and Venereology, Dharmais Cancer National Hospital, Jakarta, Indonesia.'}, {'ForeName': 'Hanny', 'Initials': 'H', 'LastName': 'Nilasari', 'Affiliation': 'Department of Dermatology and Venereology, Faculty of Medicine Universitas Indonesia-Cipto Mangunkusumo National General Hospital, Jakarta, Indonesia.'}, {'ForeName': 'Wresti', 'Initials': 'W', 'LastName': 'Indriatmi', 'Affiliation': 'Department of Dermatology and Venereology, Faculty of Medicine Universitas Indonesia-Cipto Mangunkusumo National General Hospital, Jakarta, Indonesia.'}]",International journal of STD & AIDS,['10.1177/0956462420925250'] 2538,32605509,"Practice, clinician, and patient factors associated with the adoption of lung cancer screening.","OBJECTIVES Lung cancer remains the leading cause of cancer-related deaths in the United States. In 2013, the US Preventive Services Task Force recommended annual screening for lung cancer with low-dose computed tomography in adults meeting certain criteria. This study seeks to assess lung cancer screening uptake in three health systems. SETTING This study was part of a randomized controlled trial to engage underserved populations in preventive care and includes 45 primary care practices in eight states. METHODS Practice and clinician characteristics were manually collected. Lung cancer was measured from electronic health record data. A generalized linear mixed model was used to assess characteristics associated with screening. RESULTS Patient records between 2012 and 2016 were examined. Lung cancer screening uptake overall increased only slightly after the guideline change (2.8-5.6%, p < 0.01). One health system did not show an increase in uptake (0.2-0.1%, p = 0.32), another had a clinically insignificant increase (1.5-2.9%, p < 0.01), and the third nearly doubled its higher baseline screening rate (10.4-19.1%, p < 0.01). Within the third health system, patients more likely to be screened were older, male, had more comorbid conditions, visited the office more frequently, were seen in practices closer to the screening clinic, or were uninsured or covered by Medicare or Medicaid. CONCLUSIONS Certain patients appeared more likely to be screened. The only health system with increased lung cancer screening explicitly promoted screening rather than relying on clinicians to implement the new guideline. Systems approaches may help increase the low uptake of lung cancer screening.",2020,"One health system did not show an increase in uptake (0.2-0.1%, p = 0.32), another had a clinically insignificant increase (1.5-2.9%, p < 0.01), and the third nearly doubled its higher baseline screening rate (10.4-19.1%, p < 0.01).","['patients more likely to be screened were older, male, had more comorbid conditions, visited the office more frequently, were seen in practices closer to the screening clinic, or were uninsured or covered by Medicare or Medicaid', 'engage underserved populations in preventive care and includes 45 primary care practices in eight states', 'Patient records between 2012 and 2016 were examined']",[],"['lung cancer screening uptake', 'uptake', 'baseline screening rate', 'Lung cancer', 'Lung cancer screening uptake overall']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332148', 'cui_str': 'Probable diagnosis'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C1275743', 'cui_str': 'Co-morbid conditions'}, {'cui': 'C0442603', 'cui_str': 'Office'}, {'cui': 'C0332183', 'cui_str': 'Frequent'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0087134', 'cui_str': 'Uninsured'}, {'cui': 'C0439844', 'cui_str': 'Covered'}, {'cui': 'C0018717', 'cui_str': 'Health Insurance for Aged and Disabled, Title 18'}, {'cui': 'C0025071', 'cui_str': 'Medicaid coverage'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0872319', 'cui_str': 'Patients, Underserved'}, {'cui': 'C4277527', 'cui_str': 'Preventative Care'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0025102', 'cui_str': 'Medical record'}, {'cui': 'C0332128', 'cui_str': 'Examined for'}]",[],"[{'cui': 'C0281477', 'cui_str': 'Screening for malignant neoplasm of lung'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0242379', 'cui_str': 'Malignant tumor of lung'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",,0.0502921,"One health system did not show an increase in uptake (0.2-0.1%, p = 0.32), another had a clinically insignificant increase (1.5-2.9%, p < 0.01), and the third nearly doubled its higher baseline screening rate (10.4-19.1%, p < 0.01).","[{'ForeName': 'Camille J', 'Initials': 'CJ', 'LastName': 'Hochheimer', 'Affiliation': 'Department of Public Health Sciences, University of Virginia, Charlottesville, USA.'}, {'ForeName': 'Roy T', 'Initials': 'RT', 'LastName': 'Sabo', 'Affiliation': 'Department of Biostatistics, Virginia Commonwealth University, Richmond, USA.'}, {'ForeName': 'Sebastian T', 'Initials': 'ST', 'LastName': 'Tong', 'Affiliation': 'Department of Family Medicine and Population Health, Virginia Commonwealth University, Richmond, USA.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Westfall', 'Affiliation': 'Department of Family Medicine and Population Health, Virginia Commonwealth University, Richmond, USA.'}, {'ForeName': 'Susan E', 'Initials': 'SE', 'LastName': 'Wolver', 'Affiliation': 'Department of Internal Medicine, Virginia Commonwealth University, Richmond, USA.'}, {'ForeName': 'Stacie', 'Initials': 'S', 'LastName': 'Carney', 'Affiliation': 'OCHIN, Portland, USA.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Day', 'Affiliation': 'Department of Family Medicine and Population Health, Virginia Commonwealth University, Richmond, USA.'}, {'ForeName': 'Alex H', 'Initials': 'AH', 'LastName': 'Krist', 'Affiliation': 'Department of Family Medicine and Population Health, Virginia Commonwealth University, Richmond, USA.'}]",Journal of medical screening,['10.1177/0969141320937326'] 2539,32605536,Effectiveness of SMS messaging for diarrhoea measurement: a factorial cross-over randomised controlled trial.,"BACKGROUND Text messaging systems are used to collect data on symptom prevalence. Using a text messaging system, we evaluated the effects of question load, question frequency, and financial incentive on response rates and reported infant diarrhoea rates in an infant diarrhoea survey. METHODS We performed a factorial cross-over randomised controlled trial of an SMS surveying system for infant diarrhoea surveillance with treatments: financial incentive (yes/no), question load (1-question/3-question), and questioning frequency (daily/fortnightly). Participants progressed through all treatment combinations over eight two-week rounds. Data were analysed using multivariable logistic regressions to determine the impacts of the treatments on the response rates and reported diarrhoea rates. Attitudes were explored through qualitative interviews. RESULTS For the 141 participants, the mean response rate was 47%. In terms of percentage point differences (ppd), daily questioning was associated with a lower response rate than fortnightly (- 1·2[95%CI:-4·9,2·5]); high (3-question) question loads were associated with a lower response rate than low (1-question) question loads (- 7·0[95%CI:- 10·8,-3·1]); and financial incentivisation was associated with a higher response rate than no financial incentivisation (6·4[95%CI:2·6,10·2]). The mean two-week diarrhoea rate was 36·4%. Daily questioning was associated with a higher reported diarrhoea rate than fortnightly (29·9[95%CI:22·8,36·9]); with little evidence for impact by incentivisation or question load. CONCLUSIONS Close to half of all participants responded to the SMS survey. Daily questioning evoked a statistically higher rate of reported diarrhoea, while financial incentivisation and low (1-question) question loads evoked higher response rates than no incentive and high (3-question) question loads respectively. TRIAL REGISTRATION The protocol was prospectively registered on ISRCTN on the 20th of March 2019 under number ISRCTN11410773 .",2020,"In terms of percentage point differences (ppd), daily questioning was associated with a lower response rate than fortnightly (- 1·2[95%CI:-4·9,2·5]); high (3-question) question loads were associated with a lower response rate than low (1-question) question loads (- 7·0[95%CI:- 10·8,-3·1]); and financial incentivisation was associated with a higher response rate than no financial incentivisation (6·4[95%CI:2·6,10·2]).",[],"['SMS surveying system', 'SMS messaging']","['mean two-week diarrhoea rate', 'rate of reported diarrhoea', 'diarrhoea rate', 'mean response rate', 'response rates and reported diarrhoea rates', 'diarrhoea measurement']",[],"[{'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C4082118', 'cui_str': 'Two weeks'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}]",,0.319071,"In terms of percentage point differences (ppd), daily questioning was associated with a lower response rate than fortnightly (- 1·2[95%CI:-4·9,2·5]); high (3-question) question loads were associated with a lower response rate than low (1-question) question loads (- 7·0[95%CI:- 10·8,-3·1]); and financial incentivisation was associated with a higher response rate than no financial incentivisation (6·4[95%CI:2·6,10·2]).","[{'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Rego', 'Affiliation': 'Warwick International Centre for Applied Health Research and Delivery, Warwick Medical School, University of Warwick, Coventry, UK. Ryan.rego@warwick.ac.uk.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Watson', 'Affiliation': 'Warwick International Centre for Applied Health Research and Delivery, Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'Philbert', 'Initials': 'P', 'LastName': 'Ishengoma', 'Affiliation': 'The United Nations Human Settlement Program, Mwanza, Tanzania.'}, {'ForeName': 'Philemon', 'Initials': 'P', 'LastName': 'Langat', 'Affiliation': 'The United Nations Human Settlement Program, Nairobi, Kenya.'}, {'ForeName': 'Hezekiah Pireh', 'Initials': 'HP', 'LastName': 'Otieno', 'Affiliation': 'The United Nations Human Settlement Program, Nairobi, Kenya.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Lilford', 'Affiliation': 'Warwick International Centre for Applied Health Research and Delivery, Warwick Medical School, University of Warwick, Coventry, UK.'}]",BMC medical research methodology,['10.1186/s12874-020-01062-3'] 2540,32605552,The study protocol for a pseudo-randomised pre-post designed controlled intervention trial to study the effects of a 7-week cooking program on self-efficacy and biomarkers of health: the ECU lifestyle and biomarkers get connected study (ECULABJMOF) including the Jamie's Ministry of Food WA participant experience.,"BACKGROUND Australia, like other nations, has experienced a shift in dietary patterns away from home cooking of nutritious foods, towards a reliance on pre-prepared convenience meals. These are typically energy-dense, nutrient-poor and contribute to the rising prevalence of obesity and chronic disease burden. The aims of this study were to evaluate whether a community-based cooking program instigated a change to participants' skills, attitudes, knowledge, enjoyment and satisfaction of cooking and cooking confidence (self-efficacy). METHODS The pseudo-random, pre-post study design consisted of an intervention and a control group. Participant recruitment and group allocation was based on their program start dates. Intervention participants were surveyed three times (baseline, 7 weeks and 6 months) and the control group were surveyed at baseline and 5 weeks. All participants were registered via an online website and were 18 years or over. Upon consent, participants were offered four levels of commitment, defined by different assessments. The minimum participation level included an online survey and levels 2, 3 and 4 involved attendance at a clinic with increasing functional, anthropometric and biomarker measurements. Primary endpoints were participants' cooking confidence as a proxy for self-efficacy. Secondary endpoints were dietary intake, physical activity levels, body composition, anthropometry, blood, urine and faecal biomarkers of systemic, physical and mental health. DISCUSSION The community cooking program provided participants with information and advice on food sourcing, preparation and nutrition to improve home cooking skills. The study was designed to explore whether food literacy programs are efficacious in improving participant physical health and well-being in order to combat the rise in obesity and diet-related disease. It will support future use of public health cooking program initiatives aimed at improving food literacy, self-efficacy and physical and mental health. The extensive data collected will inform future research into the relationship between diet, the gut-microbiota and human health. TRIAL REGISTRATION Retrospectively registered on 16.08.2019 with the Australian New Zealand Clinical Trials Registry (ANZCTR). ACTRN12619001144101 . Protocol version 4.",2020,"It will support future use of public health cooking program initiatives aimed at improving food literacy, self-efficacy and physical and mental health.",['All participants were registered via an online website and were 18\u2009years or over'],"['community cooking program provided participants with information and advice on food sourcing, preparation and nutrition to improve home cooking skills', 'community-based cooking program', '7-week cooking program', 'food literacy programs']","['dietary intake, physical activity levels, body composition, anthropometry, blood, urine and faecal biomarkers of systemic, physical and mental health', 'cooking confidence as a proxy for self-efficacy', ""participants' skills, attitudes, knowledge, enjoyment and satisfaction of cooking and cooking confidence (self-efficacy""]","[{'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0335326', 'cui_str': 'Cookery'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0023865', 'cui_str': 'Literacy Programs'}]","[{'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0003188', 'cui_str': 'Anthropometry'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0335326', 'cui_str': 'Cookery'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0600420', 'cui_str': 'Proxy'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0679105', 'cui_str': 'Pleasure'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",,0.0328524,"It will support future use of public health cooking program initiatives aimed at improving food literacy, self-efficacy and physical and mental health.","[{'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Rees', 'Affiliation': 'School of Medical and Health Sciences, Edith Cowan University, 270 Joondalup Drive, Joondalup, Perth, WA, 6027, Australia. j.rees@ecu.edu.au.'}, {'ForeName': 'Claus C', 'Initials': 'CC', 'LastName': 'Christophersen', 'Affiliation': 'School of Medical and Health Sciences, Edith Cowan University, 270 Joondalup Drive, Joondalup, Perth, WA, 6027, Australia.'}, {'ForeName': 'Joshua R', 'Initials': 'JR', 'LastName': 'Lewis', 'Affiliation': 'School of Medical and Health Sciences, Edith Cowan University, 270 Joondalup Drive, Joondalup, Perth, WA, 6027, Australia.'}, {'ForeName': 'Johnny', 'Initials': 'J', 'LastName': 'Lo', 'Affiliation': 'School of Science, Edith Cowan University, Perth, WA, Australia.'}, {'ForeName': 'Ros', 'Initials': 'R', 'LastName': 'Sambell', 'Affiliation': 'School of Medical and Health Sciences, Edith Cowan University, 270 Joondalup Drive, Joondalup, Perth, WA, 6027, Australia.'}, {'ForeName': 'Leesa', 'Initials': 'L', 'LastName': 'Costello', 'Affiliation': 'School of Medical and Health Sciences, Edith Cowan University, 270 Joondalup Drive, Joondalup, Perth, WA, 6027, Australia.'}, {'ForeName': 'Cailyn', 'Initials': 'C', 'LastName': 'Walker', 'Affiliation': 'School of Medical and Health Sciences, Edith Cowan University, 270 Joondalup Drive, Joondalup, Perth, WA, 6027, Australia.'}, {'ForeName': 'Matt F', 'Initials': 'MF', 'LastName': 'Byrne', 'Affiliation': 'School of Education, Edith Cowan University, Perth, WA, Australia.'}, {'ForeName': 'Mary C', 'Initials': 'MC', 'LastName': 'Boyce', 'Affiliation': 'School of Science, Edith Cowan University, Perth, WA, Australia.'}, {'ForeName': 'Robert U', 'Initials': 'RU', 'LastName': 'Newton', 'Affiliation': 'School of Medical and Health Sciences, Edith Cowan University, 270 Joondalup Drive, Joondalup, Perth, WA, 6027, Australia.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Devine', 'Affiliation': 'School of Medical and Health Sciences, Edith Cowan University, 270 Joondalup Drive, Joondalup, Perth, WA, 6027, Australia.'}]",BMC public health,['10.1186/s12889-020-09124-3'] 2541,32605576,The Melanoma Genomics Managing Your Risk Study randomised controlled trial: statistical analysis plan.,"BACKGROUND The Melanoma Genomics Managing Your Risk Study is a randomised controlled trial that aims to evaluate the efficacy of providing information on personal genomic risk of melanoma in reducing ultraviolet radiation (UV) exposure, stratified by traditional risk group (low or high phenotypic risk) in the general population. The primary outcome is objectively measured total daily Standard Erythemal Doses at 12 months. Secondary outcomes include UV exposure at specific time periods, self-reported sun protection and skin-examination behaviours, psychosocial outcomes, and ethical considerations surrounding offering genomic testing at a population level. A within-trial and modelled economic evaluation will be undertaken from an Australian health system perspective to assess the cost-effectiveness of the intervention. OBJECTIVE To publish the pre-determined statistical analysis plan (SAP) before database lock and the start of analysis. METHODS This SAP describes the data synthesis, analysis principles and statistical procedures for analysing the outcomes from this trial. The SAP was approved after closure of recruitment and before completion of patient follow-up. It outlines the planned primary analyses and a range of subgroup and sensitivity analyses. Health economic outcomes are not included in this plan but will be analysed separately. The SAP will be adhered to for the final data analysis of this trial to avoid potential analysis bias that may arise from knowledge of the outcome data. RESULTS This SAP is consistent with best practice and should enable transparent reporting. CONCLUSION This SAP has been developed for the Melanoma Genomics Managing Your Risk Study and will be followed to ensure high-quality standards of internal validity and to minimise analysis bias. TRIAL REGISTRATION Prospectively registered with the Australian New Zealand Clinical Trials Registry, ID: ACTR N12617000691347 . Registered on 15 May 2017.",2020,"The SAP will be adhered to for the final data analysis of this trial to avoid potential analysis bias that may arise from knowledge of the outcome data. ",[],[],"['total daily Standard Erythemal Doses', 'UV exposure at specific time periods, self-reported sun protection and skin-examination behaviours, psychosocial outcomes, and ethical considerations surrounding offering genomic testing at a population level']",[],[],"[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0041625', 'cui_str': 'Ultraviolet radiation'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C1948053', 'cui_str': 'Time periods'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0038817', 'cui_str': 'Sunlight'}, {'cui': 'C0436149', 'cui_str': 'Examination of skin'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0026531', 'cui_str': 'Morality'}, {'cui': 'C1282914', 'cui_str': 'Circumscribed'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C0017428', 'cui_str': 'Genome'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.266838,"The SAP will be adhered to for the final data analysis of this trial to avoid potential analysis bias that may arise from knowledge of the outcome data. ","[{'ForeName': 'Serigne N', 'Initials': 'SN', 'LastName': 'Lo', 'Affiliation': 'The University of Sydney, Melanoma Institute Australia, Sydney, NSW, Australia.'}, {'ForeName': 'Amelia K', 'Initials': 'AK', 'LastName': 'Smit', 'Affiliation': 'The University of Sydney, Melanoma Institute Australia, Sydney, NSW, Australia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Espinoza', 'Affiliation': 'The University of Sydney, NHMRC Clinical Trials Centre, Sydney, NSW, Australia.'}, {'ForeName': 'Anne E', 'Initials': 'AE', 'LastName': 'Cust', 'Affiliation': 'The University of Sydney, Melanoma Institute Australia, Sydney, NSW, Australia. anne.cust@sydney.edu.au.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Trials,['10.1186/s13063-020-04351-w'] 2542,32605655,The efficacy of different treatment approaches for pediatric OSAHS patients with mandibular retrognathia: study protocol for a multicenter randomized controlled trial.,"BACKGROUND Pediatric obstructive sleep apnea/hypopnea syndrome (OSAHS) is a multifactorial syndrome caused by many risk factors, such as craniofacial anomalies, adenotonsillar hypertrophy, obesity, and airway inflammation. Although new treatment patterns have recently been proposed, treatment methods for children remain particularly challenging and controversial. This randomized controlled trial was designed to investigate the efficacy of adenotonsillectomy and/or orthodontic treatment for children who have mild OSAHS with mandibular retrognathia. METHODS A sample of 352 children with mild OSAHS and mandibular retrognathia, who are aged between 7 and 10 years, will be enrolled in the study. They will be randomized into four groups: the drug treatment group, the surgical treatment group, the orthodontic treatment group, or the surgery and postoperative orthodontic group. After randomization the children will receive treatments within 4 weeks. Outcome assessment will take place at the following points: (1) baseline, (2) 7 months after the treatment starting point, (3) 12 months after the treatment starting point, and (4) 24 months after the treatment starting point. The primary endpoint of the trial is the mean change in obstructive apnea/hypopnea index. Other endpoints will consist of the lowest oxygen saturation, apnea index, and hypopnea index assessed by polysomnography, subjective symptoms (assessed by the OSA-20 questionnaire), cephalometric measurements, and morphologic analysis of the upper airway. DISCUSSION The results of this study will provide valuable evidence for the merits and long-term efficacy of different treatment approaches and contribute to facilitating the multidisciplinary treatment of pediatric OSAHS. TRIAL REGISTRATION ClinicalTrials.gov : NCT03451318. Registered on 2 March 2018 (last update posted 19 April 2018).",2020,"This randomized controlled trial was designed to investigate the efficacy of adenotonsillectomy and/or orthodontic treatment for children who have mild OSAHS with mandibular retrognathia. ","['352 children with mild OSAHS and mandibular retrognathia, who are aged between 7 and 10\u2009years', 'Pediatric obstructive sleep apnea/hypopnea syndrome (OSAHS', 'pediatric OSAHS patients with mandibular retrognathia', 'children who have mild OSAHS with mandibular retrognathia']","['adenotonsillectomy and/or orthodontic treatment', 'orthodontic treatment group, or the surgery and postoperative orthodontic group']","['lowest oxygen saturation, apnea index, and hypopnea index assessed by polysomnography, subjective symptoms (assessed by the OSA-20 questionnaire), cephalometric measurements, and morphologic analysis of the upper airway', 'mean change in obstructive apnea/hypopnea index']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C2748060', 'cui_str': 'Hypopnea syndrome'}, {'cui': 'C4024589', 'cui_str': 'Mandibular hypoplasia'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0193959', 'cui_str': 'Tonsillectomy and adenoidectomy'}, {'cui': 'C0204193', 'cui_str': 'Orthodontic procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0332276', 'cui_str': 'Orthodontic'}]","[{'cui': 'C0746961', 'cui_str': 'Oxygen saturation below reference range'}, {'cui': 'C0003578', 'cui_str': 'Apnea'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0235546', 'cui_str': 'Slow shallow breathing'}, {'cui': 'C0162701', 'cui_str': 'Polysomnography'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0520679', 'cui_str': 'Obstructive sleep apnea syndrome'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0225377', 'cui_str': 'Structure of upper respiratory tract cavity'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]",352.0,0.107671,"This randomized controlled trial was designed to investigate the efficacy of adenotonsillectomy and/or orthodontic treatment for children who have mild OSAHS with mandibular retrognathia. ","[{'ForeName': 'Yuanyuan', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Pediatric Dentistry, Shanghai Stomatological Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Jiali', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': ""Department of Otolaryngology and Head and Neck Surgery, Shanghai Children's Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.""}, {'ForeName': 'Jinghan', 'Initials': 'J', 'LastName': 'Guo', 'Affiliation': 'Oral Biomedical Engineering Laboratory, Shanghai Stomatological Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Liming', 'Initials': 'L', 'LastName': 'Yu', 'Affiliation': 'Oral Biomedical Engineering Laboratory, Shanghai Stomatological Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': ""Department of Otolaryngology and Head and Neck Surgery, Shanghai Children's Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.""}, {'ForeName': 'Xiaoyan', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': ""Department of Otolaryngology and Head and Neck Surgery, Shanghai Children's Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China.""}, {'ForeName': 'Shuhua', 'Initials': 'S', 'LastName': 'Xu', 'Affiliation': ""Department of Oral and Craniomaxillofacial Surgery, Shanghai Ninth People's Hospital, College of Stomatology, Shanghai Jiao Tong University School of Medicine, Shanghai, China.""}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Zhu', 'Affiliation': ""Department of Oral and Craniomaxillofacial Surgery, Shanghai Ninth People's Hospital, College of Stomatology, Shanghai Jiao Tong University School of Medicine, Shanghai, China.""}, {'ForeName': 'Jinqiu', 'Initials': 'J', 'LastName': 'Feng', 'Affiliation': 'Department of Pediatric Dentistry, Shanghai Stomatological Hospital, Fudan University, Shanghai, China.'}, {'ForeName': 'Yuehua', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Oral Biomedical Engineering Laboratory, Shanghai Stomatological Hospital, Fudan University, Shanghai, China. liuyuehua@fudan.edu.cn.'}]",Trials,['10.1186/s13063-020-04398-9'] 2543,32605697,Long-term efficacy of injected allergen immunotherapy for treatment of grass pollen allergy in elderly patients with allergic rhinitis.,"Background: The effect of prolonged allergen immunotherapy is still insufficiently known, especially in elderly patients. Objective: The effect after a 3-year course of injected allergen-specific immunotherapy (AIT) for grass pollen allergy in elderly patients with allergic rhinitis was observed. Methods: Thirty-eight elderly patients (mean ± standard deviation, 66.2 ± 2.7 years old) who received preseasonal injected AIT or placebo for grass pollen allergy were monitored for 3 years and compared with a placebo group. The combined symptom medication score (CSMS), serum level of immunoglobulin G4 (IgG4) to phleum pratense 5 (Phl p5) and quality of life were assessed immediately after AIT and 3 years later. Results: After AIT, the CSMS was significantly decreased from 2.15 (range, 1.27-3.00) to 1.13 (range, 0.79-1.36) (p = 0.03) and remained lower (1.41 ± 0.72 versus 2.41 ± 1.11) than that in the placebo group during the 3 years after AIT. Serum-specific IgG4 against increased during the course of AIT and remained at a high level during further observation. Quality of life, based on the Rhinoconjunctivitis Quality of Life Questionnaire, was significantly decreased in the patients who received AIT from 1.51 (95% confidence interval [CI], 1.21-1.84) to 1.01 (95% CI, 0.93-1.87) (p < 0.05) and was decreased to 0.97-1.26 (95% CI, 0.88-1.82) during the 3 years after discontinuation of AIT. Conclusion: A prolonged positive effect after AIT for grass pollen allergy was observed in elderly patients with allergic rhinitis. Further trials are needed to confirm this effect.Clinical trial MC56871/12, www.clinicaltrials.gov.",2020,"Quality of life, based on the Rhinoconjunctivitis Quality of Life Questionnaire, was significantly decreased in the patients who received AIT from 1.51 (95% confidence interval [CI], 1.21-1.84) to 1.01 (95% CI, 0.93-1.87) (p < 0.05) and was decreased to 0.97-1.26 (95% CI, 0.88-1.82) during the 3 years after discontinuation of AIT. ","['elderly patients with allergic rhinitis', 'Thirty-eight elderly patients (mean ± standard deviation, 66.2 ± 2.7 years old) who received', 'elderly patients']","['injected allergen-specific immunotherapy (AIT', 'preseasonal injected AIT or placebo', 'href=""http://www.clinicaltrials.gov"">www.clinicaltrials.gov 0.090). Additionally, compared to the pre-intervention phase, PINP AUC during the intervention phase was suppressed in both COC and CVR groups ( p < 0.001), while no difference was observed in the control group ( p = 0.980). Conclusion: These data suggest that changes in recombinant human GH-stimulated hepatic IGF-I synthesis in response to combined hormonal contraception (CHC) use are dependent on route of CHC administration, while the influence on PINP is route-independent. Future research is needed to expand these results with larger randomized control trials in all age ranges of women who utilize hormonal contraception. Clinical Trial Registration: www.ClinicalTrials.gov registration NCT02367833.",2020,"Compared to the pre-intervention phase, peak IGF-I concentration in response to the IGF-I Generation Test in the intervention phase was suppressed in the COC group ( p < 0.001), but not the CVR or Control groups ( p > 0.090).","['Healthy, premenopausal women not taking hormonal contraception were recruited', 'Young Women', 'women who utilize hormonal contraception']","['CVR', 'COC', 'combined oral contraception (COC) vs. contraceptive vaginal ring (CVR', 'hormonal contraceptive therapy', 'combined hormonal contraception (CHC', 'Oral and Vaginal Contraceptives']","['PINP AUC', 'peak IGF-I concentration', 'Serum IGF-I and PINP', 'recombinant human GH-stimulated hepatic IGF', 'IGF-I and procollagen type', 'peak rise in IGF-I and PINP concentration and area under the curve (AUC']","[{'cui': 'C1096235', 'cui_str': 'Premenopausal symptoms'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C2985296', 'cui_str': 'Hormonal contraception'}, {'cui': 'C0332239', 'cui_str': 'Young'}]","[{'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0029151', 'cui_str': 'Oral contraception'}, {'cui': 'C0009871', 'cui_str': 'Contraceptive agent'}, {'cui': 'C0042260', 'cui_str': 'Vaginal Ring'}, {'cui': 'C0458083', 'cui_str': 'Hormonal'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C2985296', 'cui_str': 'Hormonal contraception'}, {'cui': 'C1861453', 'cui_str': 'Pseudohyperkalemia Cardiff'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0042232', 'cui_str': 'Vaginal structure'}]","[{'cui': 'C0072053', 'cui_str': 'Procollagen peptide, type 1 N-terminal'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0021665', 'cui_str': 'Somatomedin C'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C0037657', 'cui_str': 'Somatomedin'}, {'cui': 'C0033235', 'cui_str': 'Procollagen'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0035853', 'cui_str': 'Rose'}]",,0.0683776,"Compared to the pre-intervention phase, peak IGF-I concentration in response to the IGF-I Generation Test in the intervention phase was suppressed in the COC group ( p < 0.001), but not the CVR or Control groups ( p > 0.090).","[{'ForeName': 'Heather C M', 'Initials': 'HCM', 'LastName': 'Allaway', 'Affiliation': 'Department of Kinesiology, Pennsylvania State University, University Park, PA, United States.'}, {'ForeName': 'Madhusmita', 'Initials': 'M', 'LastName': 'Misra', 'Affiliation': 'Division of Pediatric Endocrinology, Massachusetts General Hospital and Harvard Medical School, Boston, MA, United States.'}, {'ForeName': 'Emily A', 'Initials': 'EA', 'LastName': 'Southmayd', 'Affiliation': 'Department of Kinesiology, Pennsylvania State University, University Park, PA, United States.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Stone', 'Affiliation': 'Department of Nutritional Science, Purdue University, West Lafayette, IN, United States.'}, {'ForeName': 'Connie M', 'Initials': 'CM', 'LastName': 'Weaver', 'Affiliation': 'Department of Nutritional Science, Purdue University, West Lafayette, IN, United States.'}, {'ForeName': 'Dylan L', 'Initials': 'DL', 'LastName': 'Petkus', 'Affiliation': 'Department of Kinesiology, Pennsylvania State University, University Park, PA, United States.'}, {'ForeName': 'Mary Jane', 'Initials': 'MJ', 'LastName': 'De Souza', 'Affiliation': 'Department of Kinesiology, Pennsylvania State University, University Park, PA, United States.'}]",Frontiers in endocrinology,['10.3389/fendo.2020.00334'] 2569,32612701,"Protocol of a Randomised, Single Blind, Placebo-controlled RESCAP Intervention Study to Determine the Safety of RESCAP in Diabetes: RAPID Protocol - Rationale and Design.",,2020,,[],"['Placebo-controlled RESCAP', 'RESCAP']",[],[],"[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",[],,0.136856,,"[{'ForeName': 'V', 'Initials': 'V', 'LastName': 'Popov', 'Affiliation': 'Moscow, Russia.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Brands', 'Affiliation': 'Wageningen, the Netherlands.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Bulanova', 'Affiliation': 'Moscow, Russia.'}]",European cardiology,['10.15420/ecr.2020.15.1.PO18'] 2570,32612702,Evaluating the Potential Effect of L-carnitine on the Prevention of AF Following Coronary Artery Bypass Graft Surgery: A Randomised Clinical Trial.,,2020,,['AF Following Coronary Artery Bypass Graft Surgery'],['L-carnitine'],[],"[{'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0010055', 'cui_str': 'Coronary artery bypass graft'}]","[{'cui': 'C0087163', 'cui_str': 'Levocarnitine'}]",[],,0.0757969,,"[{'ForeName': 'F', 'Initials': 'F', 'LastName': 'Dastan', 'Affiliation': 'Tehran, Iran.'}]",European cardiology,['10.15420/ecr.2020.15.1.PO19'] 2571,32612707,"A Multicentre, Open-Label, Randomised Controlled Clinical Trial to Assess the Efficacy and Safety of Appropriate Target Values for Lipid Management in Patients who Have Mild to Moderate Stenotic Lesions with High-Risk Plaques in Coronary Arteries: Study Protocol.",,2020,,['Patients who Have Mild to Moderate Stenotic Lesions with High-Risk Plaques in Coronary Arteries'],[],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0333181', 'cui_str': 'Stenosed'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0205042', 'cui_str': 'Coronary artery structure'}]",[],[],,0.0962568,,"[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Matsuda', 'Affiliation': 'Kure, Hiroshima, Japan.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Hasegawa', 'Affiliation': 'Kyoto, Japan.'}]",European cardiology,['10.15420/ecr.2020.15.1.PO24'] 2572,32612763,Group cognitive intervention targeted to the strengthening of executive functions in children at social risk.,"The present study set out to evaluate the effectiveness of a group cognitive intervention aimed at promoting executive functions in children at social risk. The quasi-experimental, pretest-posttest design included a control group. The sample was made up of 178 children (52% boys), aged 6-10. The children were evaluated by means of a battery of neuropsychological EF tests and a teacher-rated behavioral EF scale. The intervention program included 30 group cognitive stimulation sessions that increased in difficulty and were embedded into school curricula. Trained children performed better in terms of cognitive flexibility, planning, metacognition and inhibitory control, as compared to their baseline values and to children in the control group. This study provides new evidence of the effectiveness of cognitive interventions for children and of children's capability to transfer cognitive improvements to daily school activities.",2017,"Trained children performed better in terms of cognitive flexibility, planning, metacognition and inhibitory control, as compared to their baseline values and to children in the control group.","[""children and of children's"", 'children at social risk', '178 children (52% boys), aged 6-10']","['cognitive interventions', '30 group cognitive stimulation sessions that increased in difficulty and were embedded into school curricula']","['cognitive flexibility, planning, metacognition and inhibitory control', 'neuropsychological EF tests and a teacher-rated behavioral EF scale']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0870221', 'cui_str': 'Male child'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0150174', 'cui_str': 'Cognitive stimulation'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0010478', 'cui_str': 'Curricula'}]","[{'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0032074', 'cui_str': 'Cognitive function: planning'}, {'cui': 'C0589513', 'cui_str': 'Metacognition'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",178.0,0.0138673,"Trained children performed better in terms of cognitive flexibility, planning, metacognition and inhibitory control, as compared to their baseline values and to children in the control group.","[{'ForeName': 'Celina', 'Initials': 'C', 'LastName': 'Korzeniowski', 'Affiliation': 'Institute of Human, Social and Environmental Sciences (INCIHUSA-CONICET), National Scientific and Technical Research Council (CONICET), Argentina. Institute of Human, Social and Environmental Sciences National Scientific and Technical Research Council Argentina.'}, {'ForeName': 'Mirta Susana', 'Initials': 'MS', 'LastName': 'Ison', 'Affiliation': 'Institute of Human, Social and Environmental Sciences (INCIHUSA-CONICET), National Scientific and Technical Research Council (CONICET), Argentina. Institute of Human, Social and Environmental Sciences National Scientific and Technical Research Council Argentina.'}, {'ForeName': 'Hilda', 'Initials': 'H', 'LastName': 'Difabio', 'Affiliation': 'Cuyo Research Center (CIC-CONICET), Mendoza, Argentina. Cuyo Research Center Mendoza Argentina.'}]",International journal of psychological research,['10.21500/20112084.2760'] 2573,32612816,Effects of therapeutic zinc supplementation for diarrhea and two preventive zinc supplementation regimens on the incidence and duration of diarrhea and acute respiratory tract infections in rural Laotian children: A randomized controlled trial.,"Background Diarrhea and respiratory tract infections are leading causes of childhood morbidity and mortality. This individually randomized, double-blind placebo-controlled trial was designed to evaluate the effects of different zinc supplementation regimens on the incidence and duration of diarrhea and acute lower (ALRI) and upper (AURI) respiratory tract infections among rural Laotian children. The study included 3407 children, 6-23 months at enrollment. Methods Children were randomized to one of four study groups: therapeutic zinc supplements for diarrhea treatment (20 mg/d for 10 days with each episode; TZ), daily preventive zinc tablets (7 mg/d; PZ), daily multiple micronutrient powder (10 mg/d zinc, 6 mg/d iron and 13 other micronutrients; MNP), or daily placebo powder for 9 months. Incidence and duration of diarrhea (≥3 liquid stools/24 hours), ALRI (persistent cough with wheezing, stridor or chest in-drawing) and AURI (purulent nasal discharge with cough) were assessed by parental report during weekly home visits and analyzed using negative binomial models. Results Baseline mean age was 14.2 ± 5.1 months, and 71% had low plasma zinc (<65 μg/dL). Overall diarrhea incidence (0.61 ± 0.01 episodes/100 days at risk) and duration (2.12 ± 0.03 days/episode) did not differ by study group. Age modified the impact of the interventions on diarrhea incidence ( P  = 0.06) and duration ( P  = 0.01). In children >18 months, TZ reduced diarrhea incidence by 24% vs MNP ( P  = 0.035), and 36% vs Control ( P  = 0.004), but there was no difference with PZ. This patterned remained when analyses were restricted to diarrhea episode occurring after the first treatment with TZ. Also, in children >18 months, TZ reduced diarrhea duration by 15% vs PZ ( P  = 0.03), and 16% vs Control ( P  = 0.03), but there was no difference with MNP. There were no overall effects of study group on incidence of ALRI (overall mean 0.005 ± 0.001 episodes/100 days, P  = 0.14) or AURI (overall mean 0.09 ± 0.01 episodes/100 days, P  = 0.72). Conclusions There was no overall impact of TZ, PZ or MNP on diarrhea, ALRI and AURI. However, in children >18 months, TZ significantly reduced both the duration of diarrhea episodes and the incidence of future diarrhea episodes compared with placebo. Trial registration ClinicalTrials.gov: NCT02428647.",2020,"In children >18 months, TZ reduced diarrhea incidence by 24% vs MNP ( P  = 0.035), and 36% vs Control ( P  = 0.004), but there was no difference with PZ.","['3407 children, 6-23 months at enrollment', 'rural Laotian children']","['therapeutic zinc supplements for diarrhea treatment', 'daily preventive zinc tablets (7 mg/d; PZ), daily multiple micronutrient powder (10 mg/d zinc, 6 mg/d iron and 13 other micronutrients; MNP), or daily placebo powder', 'TZ, PZ or MNP', 'zinc supplementation regimens', 'therapeutic zinc supplementation', 'placebo']","['Overall diarrhea incidence', 'Incidence and duration of diarrhea (≥3 liquid stools/24 hours), ALRI (persistent cough with wheezing, stridor or chest in-drawing) and AURI (purulent nasal discharge with cough', 'diarrhea episode', 'incidence and duration of diarrhea and acute respiratory tract infections', 'diarrhea duration', 'diarrhea, ALRI and AURI', 'incidence of ALRI', 'AURI', 'incidence and duration of diarrhea and acute lower (ALRI) and upper (AURI) respiratory tract infections', 'low plasma zinc', 'diarrhea incidence', 'duration of diarrhea episodes and the incidence of future diarrhea episodes']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0023033', 'cui_str': 'Lao language'}]","[{'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C3541396', 'cui_str': 'Zinc'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0204169', 'cui_str': 'Preventive dental procedure'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0040577', 'cui_str': 'Trace element'}, {'cui': 'C0032861', 'cui_str': 'Powder'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0282245', 'cui_str': 'Northern Mariana Islands'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4524022', 'cui_str': 'Zinc supplementation'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0301571', 'cui_str': 'Liquid diet'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0562483', 'cui_str': 'Persistent cough'}, {'cui': 'C0043144', 'cui_str': 'Wheezing'}, {'cui': 'C0038450', 'cui_str': 'Stridor'}, {'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0013113', 'cui_str': 'Drawings'}, {'cui': 'C0264272', 'cui_str': 'Purulent rhinitis'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C4759838', 'cui_str': 'Acute respiratory tract infection'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0041912', 'cui_str': 'Upper respiratory infection'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C0016884', 'cui_str': 'Future'}]",3407.0,0.421252,"In children >18 months, TZ reduced diarrhea incidence by 24% vs MNP ( P  = 0.035), and 36% vs Control ( P  = 0.004), but there was no difference with PZ.","[{'ForeName': 'Maxwell A', 'Initials': 'MA', 'LastName': 'Barffour', 'Affiliation': 'Institute for Global Nutrition, University of California, Davis, California, USA.'}, {'ForeName': 'Guy-Marino', 'Initials': 'GM', 'LastName': 'Hinnouho', 'Affiliation': 'Institute for Global Nutrition, University of California, Davis, California, USA.'}, {'ForeName': 'K Ryan', 'Initials': 'KR', 'LastName': 'Wessells', 'Affiliation': 'Institute for Global Nutrition, University of California, Davis, California, USA.'}, {'ForeName': 'Sengchanh', 'Initials': 'S', 'LastName': 'Kounnavong', 'Affiliation': ""Lao Tropical and Public Health Institute, Vientiane, Lao People's Democratic Republic.""}, {'ForeName': 'Kethmany', 'Initials': 'K', 'LastName': 'Ratsavong', 'Affiliation': ""Lao Tropical and Public Health Institute, Vientiane, Lao People's Democratic Republic.""}, {'ForeName': 'Dalaphone', 'Initials': 'D', 'LastName': 'Sitthideth', 'Affiliation': ""Lao Tropical and Public Health Institute, Vientiane, Lao People's Democratic Republic.""}, {'ForeName': 'Bangone', 'Initials': 'B', 'LastName': 'Bounheuang', 'Affiliation': ""Lao Tropical and Public Health Institute, Vientiane, Lao People's Democratic Republic.""}, {'ForeName': 'Khanpaseuth', 'Initials': 'K', 'LastName': 'Sengnam', 'Affiliation': ""Lao Tropical and Public Health Institute, Vientiane, Lao People's Democratic Republic.""}, {'ForeName': 'Bigphone', 'Initials': 'B', 'LastName': 'Chanhthavong', 'Affiliation': ""Lao Tropical and Public Health Institute, Vientiane, Lao People's Democratic Republic.""}, {'ForeName': 'Charles D', 'Initials': 'CD', 'LastName': 'Arnold', 'Affiliation': 'Institute for Global Nutrition, University of California, Davis, California, USA.'}, {'ForeName': 'Kenneth H', 'Initials': 'KH', 'LastName': 'Brown', 'Affiliation': 'Institute for Global Nutrition, University of California, Davis, California, USA.'}, {'ForeName': 'Charles P', 'Initials': 'CP', 'LastName': 'Larson', 'Affiliation': 'School of Population and Global Health, McGill University, Montreal, Canada.'}, {'ForeName': 'Sonja Y', 'Initials': 'SY', 'LastName': 'Hess', 'Affiliation': 'Institute for Global Nutrition, University of California, Davis, California, USA.'}]",Journal of global health,['10.7189/jogh.10.010424'] 2574,32612843,Effect of Maintenance Intravenous Iron Treatment on Erythropoietin Dose in Chronic Hemodialysis Patients: A Multicenter Randomized Controlled Trial.,"Background There is no consensus on intravenous (IV) iron supplement dose, schedule, and serum ferritin target in functional iron deficiency anemia to maintain optimum target levels of iron stores by several guidelines. Objective To examine the effect of IV iron supplementation to different targets of serum ferritin on erythropoietin dose and inflammatory markers in chronic hemodialysis (HD) patients with functional iron deficiency anemia. Design A multicenter, randomized, open-label study. Setting In a developing country, Thailand. Patients Chronic HD patients with functional iron deficiency anemia. Measurements Erythropoietin resistance index, high-sensitivity C-reactive protein, and fibroblast growth factor 23. Methods Two hundred adult chronic HD patients with transferrin saturation less than 30% and serum ferritin of 200 to 400 ng/mL were randomized 1:1 to maintain serum ferritin 200 to 400 ng/mL (low-serum ferritin group, N = 100) or 600 to 700 ng/mL (high-serum ferritin group, N = 100). During a 6-week titration period, participants randomized to the high-serum ferritin group initially received 600 mg IV iron (100 mg every week), while the participants in the low-serum ferritin group did not receive IV iron. During the 6-month follow-up period, the dose of IV iron was adjusted by protocol. Results The mean dose of IV iron was 108.3 ± 28.2 mg/month in the low-serum ferritin group and 192.3 ± 36.2 mg/month in the high-serum ferritin group. The mean serum ferritin was 367.0 ± 224.9 ng/mL in the low ferritin group and 619.6 ± 265.2 ng/mL in the high ferritin group. The erythropoietin resistance index was significantly decreased in the high-serum ferritin group compared to the low-serum ferritin group after receiving IV iron in the 6-week titration period (mean difference: -113.43 ± 189.14 vs 41.08 ± 207.38 unit/week/g/dL; P < .001) and 3-month follow-up period (mean differences: -88.88 ± 234.43 vs -10.48 ± 217.75 unit/week/g/dL; P = .02). Limitations Short follow-up period. Conclusion Maintaining a serum ferritin level of 600 to 700 ng/mL by IV iron administration of approximately 200 mg per month as a maintenance protocol can decrease erythropoietin dose requirements in chronic HD patients with functional iron deficiency anemia. Trials registration The study was registered with the Thai Clinical Trials Registry TCTR20180903003.",2020,"The erythropoietin resistance index was significantly decreased in the high-serum ferritin group compared to the low-serum ferritin group after receiving IV iron in the 6-week titration period (mean difference: -113.43 ± 189.14 vs 41.08 ± 207.38 unit/week/g/dL; P < .001) and 3-month follow-up period (mean differences: -88.88 ± 234.43 vs -10.48 ± 217.75 unit/week/g/dL; P = .02). ","['Chronic Hemodialysis Patients', 'Patients\n\n\nChronic HD patients with functional iron deficiency anemia', 'Two hundred adult chronic HD patients with transferrin saturation less than 30% and serum ferritin of 200 to 400 ng/mL', 'chronic HD patients with functional iron deficiency anemia', 'chronic hemodialysis (HD) patients with functional iron deficiency anemia']","['IV iron supplementation', 'low-serum ferritin group did not receive IV iron', 'maintain serum ferritin 200 to 400 ng/mL (low-serum ferritin group, N = 100) or 600 to 700 ng/mL (high-serum ferritin']","['mean serum ferritin', 'erythropoietin resistance index', 'Measurements\n\n\nErythropoietin resistance index, high-sensitivity C-reactive protein, and fibroblast growth factor 23', 'erythropoietin dose requirements', 'serum ferritin level']","[{'cui': 'C1740835', 'cui_str': 'Chronic haemodialysis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0162316', 'cui_str': 'Iron deficiency anemia'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1277709', 'cui_str': 'Transferrin saturation'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0696113', 'cui_str': 'Serum ferritin measurement'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0439275', 'cui_str': 'ug/L'}]","[{'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C3537005', 'cui_str': 'Iron supplement therapy'}, {'cui': 'C4076066', 'cui_str': 'Low serum ferritin'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0696113', 'cui_str': 'Serum ferritin measurement'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0439275', 'cui_str': 'ug/L'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C4517862', 'cui_str': '700'}, {'cui': 'C0205250', 'cui_str': 'High'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0696113', 'cui_str': 'Serum ferritin measurement'}, {'cui': 'C0014822', 'cui_str': 'erythropoietin'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0962301', 'cui_str': 'Fibroblast growth factor 23'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}]",200.0,0.0386168,"The erythropoietin resistance index was significantly decreased in the high-serum ferritin group compared to the low-serum ferritin group after receiving IV iron in the 6-week titration period (mean difference: -113.43 ± 189.14 vs 41.08 ± 207.38 unit/week/g/dL; P < .001) and 3-month follow-up period (mean differences: -88.88 ± 234.43 vs -10.48 ± 217.75 unit/week/g/dL; P = .02). ","[{'ForeName': 'Paweena', 'Initials': 'P', 'LastName': 'Susantitaphong', 'Affiliation': 'Division of Nephrology, Department of Medicine, Chulalongkorn University, King Chulalongkorn Memorial Hospital, Bangkok, Thailand.'}, {'ForeName': 'Monchai', 'Initials': 'M', 'LastName': 'Siribumrungwong', 'Affiliation': 'Nephrology Unit, Department of Medicine, Lerdsin Hospital, College of Medicine, Rangsit University, Bangkok, Thailand.'}, {'ForeName': 'Kullaya', 'Initials': 'K', 'LastName': 'Takkavatakarn', 'Affiliation': 'Division of Nephrology, Department of Medicine, Chulalongkorn University, King Chulalongkorn Memorial Hospital, Bangkok, Thailand.'}, {'ForeName': 'Kamonrat', 'Initials': 'K', 'LastName': 'Chongthanakorn', 'Affiliation': 'Nephrology Unit, Department of Medicine, Charoenkrung Pracharak Hospital, Bangkok, Thailand.'}, {'ForeName': 'Songkiat', 'Initials': 'S', 'LastName': 'Lieusuwan', 'Affiliation': 'Boonyavej Hospital, Bangkok, Thailand.'}, {'ForeName': 'Pisut', 'Initials': 'P', 'LastName': 'Katavetin', 'Affiliation': 'Division of Nephrology, Department of Medicine, Chulalongkorn University, King Chulalongkorn Memorial Hospital, Bangkok, Thailand.'}, {'ForeName': 'Khajohn', 'Initials': 'K', 'LastName': 'Tiranathanagul', 'Affiliation': 'Division of Nephrology, Department of Medicine, Chulalongkorn University, King Chulalongkorn Memorial Hospital, Bangkok, Thailand.'}, {'ForeName': 'Sookruetai', 'Initials': 'S', 'LastName': 'Lekhyananda', 'Affiliation': 'The Kidney Foundation of Thailand, Bangkok, Thailand.'}, {'ForeName': 'Kriang', 'Initials': 'K', 'LastName': 'Tungsanga', 'Affiliation': 'Division of Nephrology, Department of Medicine, Chulalongkorn University, King Chulalongkorn Memorial Hospital, Bangkok, Thailand.'}, {'ForeName': 'Supat', 'Initials': 'S', 'LastName': 'Vanichakarn', 'Affiliation': 'The Kidney Foundation of Thailand, Bangkok, Thailand.'}, {'ForeName': 'Somchai', 'Initials': 'S', 'LastName': 'Eiam-Ong', 'Affiliation': 'Division of Nephrology, Department of Medicine, Chulalongkorn University, King Chulalongkorn Memorial Hospital, Bangkok, Thailand.'}, {'ForeName': 'Kearkiat', 'Initials': 'K', 'LastName': 'Praditpornsilpa', 'Affiliation': 'Division of Nephrology, Department of Medicine, Chulalongkorn University, King Chulalongkorn Memorial Hospital, Bangkok, Thailand.'}]",Canadian journal of kidney health and disease,['10.1177/2054358120933397'] 2575,32612882,Feasibility of a smartphone app to enhance physical activity in progressive MS: a pilot randomized controlled pilot trial over three months.,"Background People with chronic progressive multiple sclerosis (CPMS) have limited options in medical treatment. Enhancing physical activity (PA) might promote neuroregeneration in multiple sclerosis (MS) and positively influence disability, thus providing an alternative to medical treatment. Previous studies indicate that evidence-based patient information (EBPI) is essential for inducing behavioral change, e.g. enhancing PA. Objective To investigate feasibility of a smartphone app providing EBPI about the benefit of PA and a simple activity feedback to enhance PA in people with CPMS in a pilot randomized controlled trial over 3 months. Methods Thirty-eight people with CPMS (mean age 51 years, median Expanded Disability Status Scale 4.0) were 1:1 randomized into either a control group ( n = 20) or an intervention group ( n = 18). The intervention group received access to a multimedia EBPI app including activity feedback, texts, figures and videos. In the control group, participants received a leaflet with unspecific information about exercising in general. The EPBI itself was designed based on a systematic review. At baseline and after 3 months, all participants underwent clinical performance tests, filled in questionnaires and received an activity monitor (Actigraph ® ) for 7 days. The primary endpoint was the rate of responders defined as participants with a 20% increase of physical acitivity (time of moderate or vigiorous PA-MVPA) or 20% increase of the number of steps, both assessed with the activity monitor. As secondary endpoints, we compared accelerometry, performance and questionnaires adjusted for baseline measurments between the groups (ANCOVA). Moreover, we used questionnaires to compare knowledge about exercise (activity requiring physical effort, carried out to improve or improve health and fitness) in MS, usability of the app in general and motivation towards a more active lifestyle after 3 months in both groups. Results The groups showed significant differences in disease duration and PA according to the Godin-Leisure Time Exercise Questionnaire at baseline. After 3 months, we detected no difference in the rate of responders, which was an overall 22%. However, MVPA significantly increased in both groups ( p < 0.001) and the intervention group tended to have a higher motivation towards a more active lifestyle (Cohens D = 0.7, p = 0.09) as measured by the questionnaire. Reponses also showed, that participants appreciated the app but claimed a lack of interactivity as a short-coming. Conclusion Just providing information in a multimedia smartphone app did not enhance physical activitiy more than a simple leaflet in this small pilot trial in CPMS. However, the group of app users tended to have a higher motivation towards a more active lifestyle. Overall, the concept of a smartphone app to support an active lifestyle in MS is highly appreciated by participants.",2020,"However, MVPA significantly increased in both groups ( p < 0.001) and the intervention group tended to have a higher motivation towards a more active lifestyle (Cohens D = 0.7, p = 0.09) as measured by the questionnaire.","['\n\n\nPeople with chronic progressive multiple sclerosis (CPMS', 'progressive MS', 'Methods\n\n\nThirty-eight people with CPMS (mean age 51 years, median Expanded Disability Status Scale 4.0', 'people with CPMS']","['smartphone app providing EBPI', 'smartphone app', 'activity monitor (Actigraph ® ', 'Enhancing physical activity (PA', 'leaflet with unspecific information about exercising in general', 'access to a multimedia EBPI app including activity feedback, texts, figures and videos']","['rate of responders', 'physical activitiy', 'physical activity', 'disease duration and PA according to the Godin-Leisure Time Exercise Questionnaire', 'accelerometry, performance and questionnaires adjusted for baseline measurments', 'MVPA', 'higher motivation towards a more active lifestyle', 'physical acitivity (time of moderate or vigiorous PA-MVPA']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0393665', 'cui_str': 'Chronic progressive multiple sclerosis'}, {'cui': 'C1095979', 'cui_str': 'Progressive multiple sclerosis'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0450361', 'cui_str': '38'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0451246', 'cui_str': 'Kurtzke multiple sclerosis rating scale'}]","[{'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4264352', 'cui_str': 'Activity Trackers'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0376478', 'cui_str': 'Multimedium'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0042655', 'cui_str': 'Video'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0086542', 'cui_str': 'Leisure'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0441677', 'cui_str': 'Accelerometry'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C4082107', 'cui_str': 'High motivation'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}]",38.0,0.0857258,"However, MVPA significantly increased in both groups ( p < 0.001) and the intervention group tended to have a higher motivation towards a more active lifestyle (Cohens D = 0.7, p = 0.09) as measured by the questionnaire.","[{'ForeName': 'Navina N', 'Initials': 'NN', 'LastName': 'Nasseri', 'Affiliation': 'Institute of Neuroimmunology and Multiple Sclerosis (INIMS), University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Eghbal', 'Initials': 'E', 'LastName': 'Ghezelbash', 'Affiliation': 'Institute of Neuroimmunology and Multiple Sclerosis (INIMS), University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Yuyang', 'Initials': 'Y', 'LastName': 'Zhai', 'Affiliation': 'Institute of Neuroimmunology and Multiple Sclerosis (INIMS), University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Patra', 'Affiliation': 'Universitäres Kompetenzzentrum für Sport-und Bewegungsmedizin (Athleticum) und Institut und Poliklinik für Medizinische Psychologie, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Karin', 'Initials': 'K', 'LastName': 'Riemann-Lorenz', 'Affiliation': 'Institute of Neuroimmunology and Multiple Sclerosis (INIMS), University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Heesen', 'Affiliation': 'Institute of Neuroimmunology and Multiple Sclerosis (INIMS), University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Anne C', 'Initials': 'AC', 'LastName': 'Rahn', 'Affiliation': 'Institute of Neuroimmunology and Multiple Sclerosis (INIMS), University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Jan-Patrick', 'Initials': 'JP', 'LastName': 'Stellmann', 'Affiliation': 'Institute of Neuroimmunology and Multiple Sclerosis (INIMS), University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}]",PeerJ,['10.7717/peerj.9303'] 2576,32612953,Radiomics Based on Multiparametric Magnetic Resonance Imaging to Predict Extraprostatic Extension of Prostate Cancer.,"Background: To develop a radiomics model based on multiparametric MRI (mpMRI) for preoperative prediction of extraprostatic extension (EPE) in patients with prostate cancer (PCa). Methods: Ninety-five pathology-confirmed PCa patients with 115 lesions (49 positive and 66 negative) were retrospectively enrolled. A 3.0T MR scanner was used to perform T2-weighted imaging (T2WI), diffusion-weighted imaging (DWI), and dynamic contrast-enhanced imaging (DCE). Radiomics features extracted from T2WI, DWI, apparent diffusion coefficient (ADC), and DCE were used to build a radiomics model. Patients' clinical and pathological variables were also obtained to build a clinical model. The radiomics model and clinical model were further integrated to build a combined nomogram. All lesions were randomly divided into the training group (82 lesions) and the validation group (33 lesions). A least absolute shrinkage and selection operator (LASSO) regression algorithm was applied to build the radiomics model. The diagnostic performance of different models was assessed by calculating the area under the curve (AUC) and compared using the Delong test. The calibration curve and decision curve analyses were used to assess the calibration and clinical usefulness of the radiomics model. Results: The AUC values for the radiomics model in the training and validation group were 0.919 and 0.865, respectively, with a good calibration performance. The decision curve analysis confirmed the clinical utility of the radiomics model. The accuracy, sensitivity, and specificity were 81.8, 71.4, and 89.5% in the validation group. In the validation group, the radiomics model outperformed the clinical model (AUC = 0.658, P = 0.020), and was comparable with the combined nomogram (AUC = 0.857, P = 0.644). Conclusion: The radiomics model based on mpMRI could different EPE and non-EPE lesions with satisfactory diagnostic performance, and this model might assist in predicting EPE before prostatectomy.",2020,"The radiomics model based on mpMRI could different EPE and non-EPE lesions with satisfactory diagnostic performance, and this model might assist in predicting EPE before prostatectomy.","['Methods: Ninety-five pathology-confirmed PCa patients with 115 lesions (49 positive and 66 negative) were retrospectively enrolled', 'patients with prostate cancer (PCa', 'Prostate Cancer']","['Multiparametric Magnetic Resonance Imaging', 'extraprostatic extension (EPE']","['T2WI, DWI, apparent diffusion coefficient (ADC), and DCE', 'accuracy, sensitivity, and specificity', 'T2-weighted imaging (T2WI), diffusion-weighted imaging (DWI), and dynamic contrast-enhanced imaging (DCE']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4517906', 'cui_str': '95'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0030131', 'cui_str': 'p-Chloramphetamine'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4517540', 'cui_str': '115'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0376358', 'cui_str': 'Malignant tumor of prostate'}]","[{'cui': 'C3898221', 'cui_str': 'Multiparametric magnetic resonance elastography'}, {'cui': 'C0231448', 'cui_str': 'Extension'}]","[{'cui': 'C0598801', 'cui_str': 'Diffusion weighted magnetic resonance imaging'}, {'cui': 'C0012222', 'cui_str': 'Diffusion'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0037791', 'cui_str': 'Specificity'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}]",,0.0128821,"The radiomics model based on mpMRI could different EPE and non-EPE lesions with satisfactory diagnostic performance, and this model might assist in predicting EPE before prostatectomy.","[{'ForeName': 'Lili', 'Initials': 'L', 'LastName': 'Xu', 'Affiliation': 'Department of Radiology, Peking Union Medical College Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences, Beijing, China.'}, {'ForeName': 'Gumuyang', 'Initials': 'G', 'LastName': 'Zhang', 'Affiliation': 'Department of Radiology, Peking Union Medical College Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences, Beijing, China.'}, {'ForeName': 'Lun', 'Initials': 'L', 'LastName': 'Zhao', 'Affiliation': 'Deepwise AI Lab, Deepwise Inc., Beijing, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Mao', 'Affiliation': 'Deepwise AI Lab, Deepwise Inc., Beijing, China.'}, {'ForeName': 'Xiuli', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Deepwise AI Lab, Deepwise Inc., Beijing, China.'}, {'ForeName': 'Weigang', 'Initials': 'W', 'LastName': 'Yan', 'Affiliation': 'Department of Urology, Peking Union Medical College Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences, Beijing, China.'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Xiao', 'Affiliation': 'Department of Pathology, Peking Union Medical College Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences, Beijing, China.'}, {'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Lei', 'Affiliation': 'Department of Radiology, Peking Union Medical College Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences, Beijing, China.'}, {'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Sun', 'Affiliation': 'Department of Radiology, Peking Union Medical College Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences, Beijing, China.'}, {'ForeName': 'Zhengyu', 'Initials': 'Z', 'LastName': 'Jin', 'Affiliation': 'Department of Radiology, Peking Union Medical College Hospital, Peking Union Medical College, Chinese Academy of Medical Sciences, Beijing, China.'}]",Frontiers in oncology,['10.3389/fonc.2020.00940'] 2577,32613023,Acute Effects of Increased Joint Mobilization Treatment Duration on Ankle Function and Dynamic Postural Control in Female Athletes With Chronic Ankle Instability.,"Background Chronic ankle instability (CAI) is linked to mechanical and functional insufficiencies. Joint mobilization is purported to be effective at treating these deficits. Purpose To examine the effect of different treatment durations of a grade IV anterior-to-posterior ankle joint mobilization on weightbearing dorsiflexion range of motion (WB-DFROM), posterior talar glide (PG), and dynamic postural control in individuals with CAI. Study Design Controlled laboratory study. Methods A total of 48 female athletes (mean age, 22.8 ± 4.8 years) with unilateral CAI participated in this study. Participants were randomly assigned to 1 of 3 treatment conditions: 30 seconds, 60 seconds, and 120 seconds. Treatment was provided to the injured limb on 3 separate occasions 48 hours apart and consisted of a Maitland grade IV anterior-to-posterior talar joint mobilization based on the participant's initial group assignment. WB-DFROM; PG; and the anterior (ANT), posteromedial (PM), and posterolateral (PL) reach directions of the Star Excursion Balance Test were measured bilaterally before and after each treatment. The uninjured limb acted as a control. Data were analyzed using 2-way mixed-model analyses of variance, and effect sizes were calculated through use of Hedges g . Results Significant differences were detected after all treatment sessions for all outcome measures ( P ≤ .001) and between treatment groups after sessions 1, 2, and 3 for all outcome measures ( P ≤ .001). Effect sizes were very large or huge for all treatment groups for WB-DFROM, PG, and ANT reach direction. Substantial variation was found in effect sizes for PM and PL measures. Conclusion Accessory mobilization is an effective treatment to induce acute changes in ankle motion and dynamic postural control in patients with CAI, with longer treatment durations conferring greater improvements. Clinical Relevance This study adds clarity to the use of joint mobilization treatments and will add to the current clinical practice strategy for patients with CAI.",2020,"Effect sizes were very large or huge for all treatment groups for WB-DFROM, PG, and ANT reach direction.","['individuals with CAI', 'patients with CAI', '48 female athletes (mean age, 22.8 ± 4.8 years) with unilateral CAI participated in this study', 'Female Athletes With Chronic Ankle Instability']","['grade IV anterior-to-posterior ankle joint mobilization', 'Increased Joint Mobilization Treatment Duration']","['anterior (ANT), posteromedial (PM), and posterolateral (PL) reach directions of the Star Excursion Balance Test', 'weightbearing dorsiflexion range of motion (WB-DFROM), posterior talar glide (PG), and dynamic postural control', 'Ankle Function and Dynamic Postural Control']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C3840097', 'cui_str': 'Chronic ankle instability'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517765', 'cui_str': '4.8'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0003087', 'cui_str': 'Ankle joint structure'}, {'cui': 'C0185112', 'cui_str': 'Mobilization'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0231588', 'cui_str': 'Physiatric mobilization of joint'}, {'cui': 'C0444921', 'cui_str': 'Duration of treatment'}]","[{'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0332195', 'cui_str': 'Posterolateral'}, {'cui': 'C0596012', 'cui_str': 'Does reach'}, {'cui': 'C0439755', 'cui_str': 'Directions'}, {'cui': 'C0282064', 'cui_str': 'Stars, Celestial'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0336966', 'cui_str': 'Gliding'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C4760618', 'cui_str': 'Posture Control'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",48.0,0.0613249,"Effect sizes were very large or huge for all treatment groups for WB-DFROM, PG, and ANT reach direction.","[{'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Holland', 'Affiliation': 'University of Worcester, Worcester, UK.'}, {'ForeName': 'Jonathan D', 'Initials': 'JD', 'LastName': 'Hughes', 'Affiliation': 'University of Gloucestershire, Gloucestershire, UK.'}, {'ForeName': 'Mark B A', 'Initials': 'MBA', 'LastName': 'De Ste Croix', 'Affiliation': 'University of Gloucestershire, Gloucestershire, UK.'}]",Orthopaedic journal of sports medicine,['10.1177/2325967120927371'] 2578,32613034,Dataset of a study investigating autologous blood patch pleurodesis in postoperative prolonged air leaks after lung resection.,"Prolonged air leak (PAL) after pulmonary resection is one if the most common complications in thoracic surgery. The dataset was obtained from a prospective randomized study investigating autologous blood patch pleurodesis in PAL. Patients were randomized to either receiving 100 ml autologous blood injected at postoperative days five and six (group A) or to watchful waiting (group B). The primary and secondary endpoints focused on differences in the duration of PAL in each group and possible complications. The results were reported in The Journal of Surgical Research. In this Data in Brief article, we provide additional data concerning pain medication and pain score during the first ten postoperative days. This should provide additional insights into the trial.",2020,Patients were randomized to either receiving 100 ml autologous blood injected at postoperative days five and six (group A) or to watchful waiting (group B).,['postoperative prolonged air leaks after lung resection'],"['autologous blood patch pleurodesis', 'Prolonged air leak (PAL', 'receiving 100\u202fml autologous blood injected at postoperative days five and six (group A) or to watchful waiting']","['duration of PAL in each group and possible complications', 'pain medication and pain score']","[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0332234', 'cui_str': 'Leaking'}, {'cui': 'C0396565', 'cui_str': 'Lung excision'}]","[{'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0332461', 'cui_str': 'Plaque'}, {'cui': 'C0189557', 'cui_str': 'Pleurodesis'}, {'cui': 'C0439590', 'cui_str': 'Prolonged'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0332234', 'cui_str': 'Leaking'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C1720154', 'cui_str': 'Inject'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0700325', 'cui_str': 'Patient status observation'}]","[{'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0332234', 'cui_str': 'Leaking'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332149', 'cui_str': 'Possible'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}]",,0.0564803,Patients were randomized to either receiving 100 ml autologous blood injected at postoperative days five and six (group A) or to watchful waiting (group B).,"[{'ForeName': 'Till', 'Initials': 'T', 'LastName': 'Ploenes', 'Affiliation': 'Department of Thoracic Surgery and Thoracic Endoscopy, Ruhrlandklinik, West German Lung Center, University Hospital Essen, University Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Ioanis', 'Initials': 'I', 'LastName': 'Kyritsis', 'Affiliation': 'Department of Thoracic Surgery and Thoracic Endoscopy, Ruhrlandklinik, West German Lung Center, University Hospital Essen, University Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Kampe', 'Affiliation': 'Department of Anesthesiology, Ruhrlandklinik, West German Lung Centre, University of Duisburg-Essen, Essen, Germany and Department of Anesthesiology and Intensive Care Medicine Germany.'}, {'ForeName': 'Khaled', 'Initials': 'K', 'LastName': 'Mardanzai', 'Affiliation': 'Department of Thoracic Surgery and Thoracic Endoscopy, Ruhrlandklinik, West German Lung Center, University Hospital Essen, University Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Langehegermann', 'Affiliation': 'Department of Thoracic Surgery and Thoracic Endoscopy, Ruhrlandklinik, West German Lung Center, University Hospital Essen, University Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Alexis', 'Initials': 'A', 'LastName': 'Slama', 'Affiliation': 'Department of Thoracic Surgery and Thoracic Endoscopy, Ruhrlandklinik, West German Lung Center, University Hospital Essen, University Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Balazs', 'Initials': 'B', 'LastName': 'Hegedüs', 'Affiliation': 'Department of Thoracic Surgery and Thoracic Endoscopy, Ruhrlandklinik, West German Lung Center, University Hospital Essen, University Duisburg-Essen, Essen, Germany.'}, {'ForeName': 'Clemens', 'Initials': 'C', 'LastName': 'Aigner', 'Affiliation': 'Department of Thoracic Surgery and Thoracic Endoscopy, Ruhrlandklinik, West German Lung Center, University Hospital Essen, University Duisburg-Essen, Essen, Germany.'}]",Data in brief,['10.1016/j.dib.2020.105789'] 2579,32613082,Theta Burst Transcranial Magnetic Stimulation of Fronto-Parietal Networks: Modulation by Mental State.,"Transcranial magnetic stimulation (TMS) treats neuropsychiatric disorders, but effects of stimulation are highly state-dependent and in most therapeutic applications, mental state is not controlled. This exploratory proposal will test the broad hypothesis that when TMS, specifically intermittent theta burst stimulation (iTBS), is applied during a controlled mental state, network changes will be facilitated, compared to stimulation when mental state is uncontrolled. We will focus on the dorsolateral prefrontal cortex (dlPFC) and the associated fronto-parietal network (FPN), which subserves cognitive control, an important neural and behavioral target of therapeutic TMS. After a baseline functional magnetic resonance imaging (fMRI) session, iTBS will be administered to 40 healthy subjects in three sessions over three days in a within-subjects, cross-over design: (1) dlPFC stimulation by iTBS alone, (2) dlPFC stimulation by iTBS while simultaneously performing a cognitive task, and (3) vertex (control) iTBS stimulation. Immediately after each iTBS session, we will measure blood oxygenation level-dependent (BOLD) activation during a cognitive control task ("" n -back"" task) and during the resting state, using BOLD connectivity and arterial spin labeling (ASL). We will test hypotheses that persisting neural changes and performance enhancement induced by iTBS to the dlPFC, compared to iTBS to the vertex, will affect the FPN, and these effects will be modulated by whether or not subjects receive iTBS when they are engaged in a cognitive control task. Demonstrating this interaction between iTBS and mental state will lay critical groundwork for future studies to show how controlling mental state during TMS can improve therapeutic effects. Trial Registration Clinicaltrials.gov NCT04010461.",2020,"Immediately after each iTBS session, we will measure blood oxygenation level-dependent (BOLD) activation during a cognitive control task ("" n -back"" task) and during the resting state, using BOLD connectivity and arterial spin labeling (ASL).",['40 healthy subjects'],"['dlPFC stimulation by iTBS alone, (2) dlPFC stimulation by iTBS while simultaneously performing a cognitive task, and (3) vertex (control) iTBS stimulation', 'Transcranial magnetic stimulation (TMS', 'baseline functional magnetic resonance imaging (fMRI) session, iTBS', 'TMS, specifically intermittent theta burst stimulation (iTBS']","['BOLD connectivity and arterial spin labeling (ASL', 'blood oxygenation level-dependent (BOLD) activation']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C4019080', 'cui_str': 'Prefrontal Cortex, Dorsolateral'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0439818', 'cui_str': 'Bursting sensation quality'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0230003', 'cui_str': 'Vertex structure'}, {'cui': 'C0436548', 'cui_str': 'Transcranial magnetic stimulation'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}]","[{'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0429964', 'cui_str': 'Dependent for dressing'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}]",40.0,0.0407966,"Immediately after each iTBS session, we will measure blood oxygenation level-dependent (BOLD) activation during a cognitive control task ("" n -back"" task) and during the resting state, using BOLD connectivity and arterial spin labeling (ASL).","[{'ForeName': 'Stephan F', 'Initials': 'SF', 'LastName': 'Taylor', 'Affiliation': 'Departments of Psychiatry, University of Michigan, Ann Arbor, MI 48109, USA.'}, {'ForeName': 'Taraz G', 'Initials': 'TG', 'LastName': 'Lee', 'Affiliation': 'Departments of Psychology, University of Michigan, Ann Arbor, MI 48109, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Jonides', 'Affiliation': 'Departments of Psychology, University of Michigan, Ann Arbor, MI 48109, USA.'}, {'ForeName': 'Ivy F', 'Initials': 'IF', 'LastName': 'Tso', 'Affiliation': 'Departments of Psychiatry, University of Michigan, Ann Arbor, MI 48109, USA.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Hernandez-Garcia', 'Affiliation': 'fMRI Laboratory, University of Michigan, Ann Arbor, MI 48109, USA.'}]",Journal of psychiatry and brain science,['10.20900/jpbs.20200011'] 2580,32606055,Supervised treatment in outpatients for schizophrenia plus (STOPS+): protocol for a cluster randomised trial of a community-based intervention to improve treatment adherence and reduce the treatment gap for schizophrenia in Pakistan.,"INTRODUCTION There is a significant treatment gap, with only a few community-based services for people with schizophrenia in low-income and middle-income countries. Poor treatment adherence in schizophrenia is associated with poorer health outcomes, suicide attempts and death. We previously reported the effectiveness of supervised treatment in outpatients for schizophrenia (STOPS) for improving treatment adherence in patients with schizophrenia. However, STOPS was evaluated in a tertiary care setting with no primary care involvement, limiting its generalisability to the wider at-risk population. We aim to evaluate the effectiveness of STOPS+ in scaling up the primary care treatment of schizophrenia to a real-world setting. METHODS AND ANALYSIS The effectiveness of the STOPS+ intervention in improving the level of functioning and medication adherence in patients with schizophrenia in Pakistan will be evaluated using a cluster randomised controlled trial design. We aim to recruit 526 participants from 24 primary healthcare centres randomly allocated in 1:1 ratio to STOPS+ intervention and enhanced treatment as usual arms. Participants will be followed-up for 12 months postrecruitment. The sample size is estimated for two outcomes (1) the primary clinical outcome is level of functioning, measured using the Global Assessment of Functioning scale and (2) the primary process outcome is adherence to treatment regimen measured using a validated measure. An intention-to-treat approach will be used for the primary analysis. ETHICS AND DISSEMINATION Ethical approval has been obtained from Keele University Ethical Review Panel (ref: MH-190017) and Khyber Medical University Ethical Review Board (ref: DIR-KMU-EB/ST/000648). The results of the STOPS+ trial will be reported in peer-reviewed journals and academic conferences and disseminated to local stakeholders and policymakers. TRIAL REGISTRATION NUMBER ISRCTN93243890.",2020,The effectiveness of the STOPS+ intervention in improving the level of functioning and medication adherence in patients with schizophrenia in Pakistan will be evaluated using a cluster randomised controlled trial design.,"['patients with schizophrenia in Pakistan', 'schizophrenia in Pakistan', 'outpatients for schizophrenia (STOPS', 'patients with schizophrenia', '526 participants from 24 primary healthcare centres randomly allocated in 1:1 ratio to', 'outpatients for schizophrenia plus (STOPS']","['STOPS+ intervention', 'STOPS+ intervention\u2009and enhanced treatment as usual arms', 'STOPS']","['level of functioning, measured using the Global Assessment of Functioning scale and (2) the primary process outcome is adherence to treatment regimen', 'level of functioning and medication adherence']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0030211', 'cui_str': 'Pakistan'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}]",526.0,0.123963,The effectiveness of the STOPS+ intervention in improving the level of functioning and medication adherence in patients with schizophrenia in Pakistan will be evaluated using a cluster randomised controlled trial design.,"[{'ForeName': 'Thomas Andrew', 'Initials': 'TA', 'LastName': 'Shepherd', 'Affiliation': 'School of Primary, Community and Social Care, Keele University, Keele, Staffordshire, UK.'}, {'ForeName': 'Zia', 'Initials': 'Z', 'LastName': 'Ul-Haq', 'Affiliation': 'Institute of Public Health & Social Sciences, Khyber Medical University, Peshawar, Khyber Pakhtunkhwa, Pakistan.'}, {'ForeName': 'Mian', 'Initials': 'M', 'LastName': 'Ul-Haq', 'Affiliation': 'Medical Teaching Institution, Lady Reading Hospital, Peshawar, Khyber Pakhtunkhwa, Pakistan.'}, {'ForeName': 'Muhammad Firaz', 'Initials': 'MF', 'LastName': 'Khan', 'Affiliation': 'Medical Teaching Institution, Lady Reading Hospital, Peshawar, Khyber Pakhtunkhwa, Pakistan.'}, {'ForeName': 'Adil', 'Initials': 'A', 'LastName': 'Afridi', 'Affiliation': 'Medical Teaching Institution, Lady Reading Hospital, Peshawar, Khyber Pakhtunkhwa, Pakistan.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Dikomitis', 'Affiliation': 'School of Primary, Community and Social Care, Keele University, Keele, Staffordshire, UK.'}, {'ForeName': 'Michelle E', 'Initials': 'ME', 'LastName': 'Robinson', 'Affiliation': 'School of Primary, Community and Social Care, Keele University, Keele, Staffordshire, UK.'}, {'ForeName': 'Martyn', 'Initials': 'M', 'LastName': 'Lewis', 'Affiliation': 'School of Primary, Community and Social Care, Keele University, Keele, Staffordshire, UK.'}, {'ForeName': 'Atif', 'Initials': 'A', 'LastName': 'Rahman', 'Affiliation': 'Child Mental Health Unit, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Krysia', 'Initials': 'K', 'LastName': 'Dziedzic', 'Affiliation': 'School of Primary, Community and Social Care, Keele University, Keele, Staffordshire, UK.'}, {'ForeName': 'Umaima', 'Initials': 'U', 'LastName': 'Saeed', 'Affiliation': 'Institute of Public Health & Social Sciences, Khyber Medical University, Peshawar, Khyber Pakhtunkhwa, Pakistan.'}, {'ForeName': 'Naila Riaz', 'Initials': 'NR', 'LastName': 'Awan', 'Affiliation': 'Medical Teaching Institution, Lady Reading Hospital, Peshawar, Khyber Pakhtunkhwa, Pakistan.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Mallen', 'Affiliation': 'School of Primary, Community and Social Care, Keele University, Keele, Staffordshire, UK.'}, {'ForeName': 'Saeed', 'Initials': 'S', 'LastName': 'Farooq', 'Affiliation': 'School of Primary, Community and Social Care, Keele University, Keele, Staffordshire, UK s.farooq@keele.ac.uk.'}]",BMJ open,['10.1136/bmjopen-2019-034709'] 2581,32606212,User-testing guidelines to improve the safety of intravenous medicines administration: a randomised in situ simulation study.,"BACKGROUND User-testing and subsequent modification of clinical guidelines increases health professionals' information retrieval and comprehension. No study has investigated whether this results in safer care. OBJECTIVE To compare the frequency of medication errors when administering an intravenous medicine using the current National Health Service Injectable Medicines Guide (IMG) versus an IMG version revised with user-testing. METHOD Single-blind, randomised parallel group in situ simulation. Participants were on-duty nurses/midwives who regularly prepared intravenous medicines. Using a training manikin in their clinical area, participants administered a voriconazole infusion, a high-risk medicine requiring several steps to prepare. They were randomised to use current IMG guidelines or IMG guidelines revised with user-testing. Direct observation was used to time the simulation and identify errors. Participant confidence was measured using a validated instrument. The primary outcome was the percentage of simulations with at least one moderate-severe IMG-related error, with error severity classified by an expert panel. RESULTS In total, 133 participants were randomised to current guidelines and 140 to user-tested guidelines. Fewer moderate-severe IMG-related errors occurred with the user-tested guidelines (n=68, 49%) compared with current guidelines (n=79, 59%), but this difference was not statistically significant (risk ratio: 0.82; 95% CI 0.66 to 1.02). Significantly more simulations were completed without any IMG-related errors with the user-tested guidelines (n=67, 48%) compared with current guidelines (n=26, 20%) (risk ratio: 2.46; 95% CI 1.68 to 3.60). Median simulation completion time was 1.6 min (95% CI 0.2 to 3.0) less with the user-tested guidelines. Participants who used user-tested guidelines reported greater confidence. CONCLUSION User-testing injectable medicines guidelines reduces the number of errors and the time taken to prepare and administer intravenous medicines, while increasing staff confidence. TRIAL REGISTRATION NUMBER researchregistry5275.",2020,"Significantly more simulations were completed without any IMG-related errors with the user-tested guidelines (n=67, 48%) compared with current guidelines (n=26, 20%) (risk ratio: 2.46; 95% CI 1.68 to 3.60).","['133 participants', 'Participants were on-duty nurses/midwives who regularly prepared intravenous medicines']",['voriconazole infusion'],"['Median simulation completion time', 'moderate-severe IMG-related errors', 'number of errors and the time taken to prepare and administer intravenous medicines', 'percentage of simulations with at least one moderate-severe IMG-related error, with error severity classified by an expert panel']","[{'cui': 'C4517563', 'cui_str': '133'}, {'cui': 'C0028661', 'cui_str': 'Nursing personnel'}, {'cui': 'C0026083', 'cui_str': 'Professional midwife'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0393080', 'cui_str': 'voriconazole'}, {'cui': 'C0574032', 'cui_str': 'Infusion'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0086466', 'cui_str': 'Injectable Product'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0441833', 'cui_str': 'Groups'}]",133.0,0.225337,"Significantly more simulations were completed without any IMG-related errors with the user-tested guidelines (n=67, 48%) compared with current guidelines (n=26, 20%) (risk ratio: 2.46; 95% CI 1.68 to 3.60).","[{'ForeName': 'Matthew D', 'Initials': 'MD', 'LastName': 'Jones', 'Affiliation': 'Department of Pharmacy and Pharmacology, University of Bath, Bath, UK M.D.Jones@bath.ac.uk.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'McGrogan', 'Affiliation': 'Department of Pharmacy and Pharmacology, University of Bath, Bath, UK.'}, {'ForeName': 'D K', 'Initials': 'DK', 'LastName': 'Raynor', 'Affiliation': 'School of Healthcare, University of Leeds, Leeds, UK.'}, {'ForeName': 'Margaret C', 'Initials': 'MC', 'LastName': 'Watson', 'Affiliation': 'Department of Pharmacy and Pharmacology, University of Bath, Bath, UK.'}, {'ForeName': 'Bryony Dean', 'Initials': 'BD', 'LastName': 'Franklin', 'Affiliation': 'Centre for Medication Safety and Service Quality, Imperial College Healthcare NHS Trust, London, UK.'}]",BMJ quality & safety,['10.1136/bmjqs-2020-010884'] 2582,32606267,Comparison of treatment outcomes in lumbar central stenosis patients treated with epidural steroid injections: interlaminar versus bilateral transforaminal approach.,"Background We aimed to compare interlaminar epidural steroid injections (ILESI) and bilateral transforaminal epidural steroid injections (TFESI) on pain intensity, functional status, depression, walking distance, and the neuropathic component in patients with lumbar central spinal stenosis (LCSS). Methods The patients were divided into either the ILESI or the bilateral TFESI groups. Prime outcome measures include the numerical rating scale (NRS), Oswestry disability index (ODI), Beck depression inventory (BDI), and pain-free walking distance. The douleur neuropathique en 4 questions score was used as a secondary outcome measure. Results A total of 72 patients were finally included. NRS, ODI, and BDI scores showed a significant decline in both groups in all follow-ups. Third-month NRS scores were significantly lower in the ILESI group ( P = 0.047). The percentages of decrease in the ODI and BDI scores between the baseline and the third week and third month were significantly higher in the ILESI group ( P = 0.017, P = 0.001 and P = 0.048, P = 0.030, respectively). Pain-free walking distance percentages from the baseline to the third week and third month were significantly higher in the ILESI group ( P = 0.036, P < 0.001). The proportion of patients with neuropathic pain in the bilateral TFESI group significantly decreased in the third week compared to the baseline ( P = 0.020). Conclusions Both ILESI and TFESI are reliable treatment options for LCSS. ILESI might be preferred because of easier application and more effectiveness. However, TFESI might be a better option in patients with more prominent neuropathic pain.",2020,"Pain-free walking distance percentages from the baseline to the third week and third month were significantly higher in the ILESI group ( P = 0.036, P < 0.001).","['lumbar central stenosis patients treated with', 'A total of 72 patients were finally included', 'patients with lumbar central spinal stenosis (LCSS', 'patients with more prominent neuropathic pain']","['ILESI', 'interlaminar epidural steroid injections (ILESI) and bilateral transforaminal epidural steroid injections (TFESI', 'epidural steroid injections: interlaminar versus bilateral transforaminal approach', 'TFESI', 'ILESI and TFESI']","['Pain-free walking distance percentages', 'proportion of patients with neuropathic pain', 'pain intensity, functional status, depression, walking distance, and the neuropathic component', 'ODI and BDI scores', 'NRS, ODI, and BDI scores', 'numerical rating scale (NRS), Oswestry disability index (ODI), Beck depression inventory (BDI), and pain-free walking distance']","[{'cui': 'C0024090', 'cui_str': 'Lumbar'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0678234', 'cui_str': 'Form of stenosis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0037944', 'cui_str': 'Spinal stenosis'}, {'cui': 'C0205402', 'cui_str': 'Prominent'}, {'cui': 'C0027796', 'cui_str': 'Neuralgia'}]","[{'cui': 'C0196394', 'cui_str': 'Epidural steroid injection'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C1562084', 'cui_str': 'Transforaminal approach'}]","[{'cui': 'C0908489', 'cui_str': 'Pain-Free'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027796', 'cui_str': 'Neuralgia'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0429886', 'cui_str': 'Walking distance'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index'}, {'cui': 'C2960571', 'cui_str': 'Beck depression inventory score'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory'}]",72.0,0.0309453,"Pain-free walking distance percentages from the baseline to the third week and third month were significantly higher in the ILESI group ( P = 0.036, P < 0.001).","[{'ForeName': 'Savas', 'Initials': 'S', 'LastName': 'Sencan', 'Affiliation': 'Division of Pain Medicine, Department of Physical Medicine and Rehabilitation, Faculty of Medicine, Marmara University, Istanbul, Turkey.'}, {'ForeName': 'Ipek Saadet', 'Initials': 'IS', 'LastName': 'Edipoglu', 'Affiliation': 'Division of Pain Medicine, Department of Physical Medicine and Rehabilitation, Faculty of Medicine, Marmara University, Istanbul, Turkey.'}, {'ForeName': 'Alp Eren', 'Initials': 'AE', 'LastName': 'Celenlioglu', 'Affiliation': 'Division of Pain Medicine, Department of Physical Medicine and Rehabilitation, Faculty of Medicine, Erciyes University, Kayseri, Turkey.'}, {'ForeName': 'Gunay', 'Initials': 'G', 'LastName': 'Yolcu', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Faculty of Medicine, Marmara University, Istanbul, Turkey.'}, {'ForeName': 'Osman Hakan', 'Initials': 'OH', 'LastName': 'Gunduz', 'Affiliation': 'Division of Pain Medicine, Department of Physical Medicine and Rehabilitation, Faculty of Medicine, Marmara University, Istanbul, Turkey.'}]",The Korean journal of pain,['10.3344/kjp.2020.33.3.226'] 2583,32606270,"Comparing the effectiveness of ultrasound guided versus blind genicular nerve block on pain, muscle strength with isokinetic device, physical function and quality of life in chronic knee osteoarthritis: a prospective randomized controlled study.","Background The genicular nerve block (GNB) is demonstrated from several reports to alleviate pain and improve knee functionality in patients with chronic knee osteoarthritis (OA). Ultrasound (US)-guided GNB has been the most used imaging method. This study aimed to compare the effectiveness of US-guided versus blind GNB in the treatment of knee OA. Methods This prospective, randomized clinical trial included patients with knee OA based on American College of Rheumatology diagnostic criteria. The patients were evaluated for clinical and dynamometer parameters at the baseline, 4 weeks after treatment, and 12 weeks after treatment. The patients underwent blind injection or US-guided injection. Results When compared with the baseline, both groups showed significant improvement in pain, physical function, and quality of life parameters. Significant differences were observed between the groups for clinical parameters (30-second chair stand test, 6-minute walk test) in favor of the US-guided group. On the other hand, blind injection was more significantly effective on some parameters of the Nottingham Health Profile. There wasn't any significant improvement in isokinetic muscle strength for either group. Conclusions This study demonstrated that both US-guided and blind GNB, in the treatment of knee OA, were effective in reducing symptoms and improving physical function. GNB wasn't an effective treatment for isokinetic muscle function. USguided injections may yield more effective clinical results than blind injections.",2020,"Significant differences were observed between the groups for clinical parameters (30-second chair stand test, 6-minute walk test) in favor of the US-guided group.","['chronic knee osteoarthritis', 'patients with knee OA based on American College of Rheumatology diagnostic criteria', 'patients with chronic knee osteoarthritis (OA']","['GNB', '\n\n\nThe genicular nerve block (GNB', 'ultrasound guided versus blind genicular nerve block', 'US-guided versus blind GNB', 'US-guided and blind GNB', 'blind injection or US-guided injection']","['isokinetic muscle strength', 'pain, physical function, and quality of life parameters', 'pain, muscle strength with isokinetic device, physical function and quality of life']","[{'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0035452', 'cui_str': 'Rheumatology'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}]","[{'cui': 'C0027741', 'cui_str': 'Nerve block'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}]","[{'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]",,0.0221508,"Significant differences were observed between the groups for clinical parameters (30-second chair stand test, 6-minute walk test) in favor of the US-guided group.","[{'ForeName': 'Damla', 'Initials': 'D', 'LastName': 'Cankurtaran', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Diskapi Yildirim Beyazit Education and Research Hospital, Ankara, Turkey.'}, {'ForeName': 'Ozgur Zeliha', 'Initials': 'OZ', 'LastName': 'Karaahmet', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Diskapi Yildirim Beyazit Education and Research Hospital, Ankara, Turkey.'}, {'ForeName': 'Sadik Yigit', 'Initials': 'SY', 'LastName': 'Yildiz', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Diskapi Yildirim Beyazit Education and Research Hospital, Ankara, Turkey.'}, {'ForeName': 'Emel', 'Initials': 'E', 'LastName': 'Eksioglu', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Diskapi Yildirim Beyazit Education and Research Hospital, Ankara, Turkey.'}, {'ForeName': 'Deniz', 'Initials': 'D', 'LastName': 'Dulgeroglu', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Diskapi Yildirim Beyazit Education and Research Hospital, Ankara, Turkey.'}, {'ForeName': 'Ece', 'Initials': 'E', 'LastName': 'Unlu', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Diskapi Yildirim Beyazit Education and Research Hospital, Ankara, Turkey.'}]",The Korean journal of pain,['10.3344/kjp.2020.33.3.258'] 2584,32606273,Re: Role of dexmedetomidine as adjuvant in postoperative sciatic popliteal and adductor canal analgesia in trauma patients: a randomized controlled trial.,,2020,,['postoperative sciatic popliteal and adductor canal analgesia in trauma patients'],['dexmedetomidine'],[],"[{'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0442037', 'cui_str': 'Popliteal'}, {'cui': 'C0225273', 'cui_str': 'Structure of adductor canal'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}]",[],,0.236022,,"[{'ForeName': 'Ki-Jae', 'Initials': 'KJ', 'LastName': 'Lee', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Jeonbuk National University Medical School, Jeonju, Korea.'}, {'ForeName': 'A Ram', 'Initials': 'AR', 'LastName': 'Doo', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Jeonbuk National University Medical School, Jeonju, Korea.'}]",The Korean journal of pain,['10.3344/kjp.2020.33.3.284'] 2585,32606274,"RE: The effect of atropine in preventing catheter-related pain and discomfort in patients undergoing transurethral resection due to bladder tumor: a prospective, randomized, controlled study.",,2020,,['patients undergoing transurethral resection due to bladder tumor'],"['atropine', 'RE']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205497', 'cui_str': 'Transurethral approach'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0005695', 'cui_str': 'Neoplasm of bladder'}]","[{'cui': 'C0004259', 'cui_str': 'Atropine'}]",[],,0.0426722,,"[{'ForeName': 'Joon-Ho', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, Soonchunhyang University Bucheon Hospial, Bucheon, Korea.'}]",The Korean journal of pain,['10.3344/kjp.2020.33.3.286'] 2586,32606490,Effects of Behavioral Skills Training on Teacher Implementation of a Reading Racetrack Intervention.,"This study examined the effects of behavioral skills training (BST) on teachers' implementation fidelity of a reading racetrack (a board game designed to increase sight word fluency) with elementary students identified as struggling readers. BST, an alternative to traditional professional development, is a performance-based protocol incorporating instruction, modeling, rehearsal, and feedback. A multiple probe design across teacher-student dyads demonstrated that BST was functionally related to the teachers' implementation of a reading racetrack with 100% fidelity on at least three consecutive sessions. Additionally, students met mastery criteria for sight word acquisition and demonstrated maintenance at least one to two weeks post intervention.",2019,"BST, an alternative to traditional professional development, is a performance-based protocol incorporating instruction, modeling, rehearsal, and feedback.",['elementary students identified as struggling readers'],"['Behavioral Skills Training', 'behavioral skills training (BST', 'BST']","['Teacher Implementation of a Reading Racetrack Intervention', 'sight word fluency']","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0205396', 'cui_str': 'Identified'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0559197', 'cui_str': 'Skills training'}]","[{'cui': 'C0221457', 'cui_str': 'Teacher'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0042926', 'cui_str': 'Vocabulary'}]",,0.0135727,"BST, an alternative to traditional professional development, is a performance-based protocol incorporating instruction, modeling, rehearsal, and feedback.","[{'ForeName': 'Carrie A', 'Initials': 'CA', 'LastName': 'Davenport', 'Affiliation': 'The Ohio State University.'}, {'ForeName': 'Sheila R', 'Initials': 'SR', 'LastName': 'Alber-Morgan', 'Affiliation': 'The Ohio State University.'}, {'ForeName': 'Moira', 'Initials': 'M', 'LastName': 'Konrad', 'Affiliation': 'The Ohio State University.'}]",Education & treatment of children,['10.1353/etc.2019.0018'] 2587,32606619,Application of Once-Monthly Self-Reported ACT Questionnaire in Management of Adherence to Inhalers in Outpatients with Asthma.,"Purpose Poor medication adherence can negatively affect health outcomes of patients with asthma from medication and significantly increase the healthcare costs. Management of adherence to inhalers remains a challenging topic in the long-term management of patients with asthma. We aim to evaluate the role of asthma control test (ACT) in the management of adherence to inhalers in outpatients with asthma. Patients and Methods Six hundred twenty-seven outpatients with asthma admitted to the clinic of respiratory medicine in a tertiary hospital in northwestern China during 2016 to 2019 were randomly divided into observation group (n= 315) and control (n= 312) and received standard inhalant therapy for 6 months and lung function test before and after treatment. The patients in the observation group took ACT questionnaires at the end of each month, while the patients in control only took an ACT at the end of the last month. The 'Test of Adherence to Inhalers' (TAI) questionnaire was used to evaluate the patients' adherence to inhalant therapy. Results All patients completed the study. The ACT scores in the observation group showed a gradual increase month by month. The TAI results indicated that adherence to inhalers of patients in the observation group was significantly better than that in control and the patients' non-adherence pattern in the observation group, with significantly lower erratic non-adherence, was also different from that in control. After 6 months of treatment, the lung function indexes and their relative improvement and the ACT scores in the observation group were significantly better or higher than those in control. Conclusion The once-monthly self-reported ACT can effectively improve the adherence to inhalers of outpatients with asthma mainly by addressing erratic non-adherence and improve the treatment effects, and thus deserves widespread use in the treatment adherence management in patients with asthma.",2020,"The TAI results indicated that adherence to inhalers of patients in the observation group was significantly better than that in control and the patients' non-adherence pattern in the observation group, with significantly lower erratic non-adherence, was also different from that in control.","['outpatients with asthma', 'patients with asthma', 'Outpatients with Asthma', 'Patients and Methods\n\n\nSix hundred twenty-seven outpatients with asthma admitted to the clinic of respiratory medicine in a tertiary hospital in northwestern China during 2016 to 2019 were randomly divided into observation group (n= 315) and control (n= 312) and received']","['Once-Monthly Self-Reported ACT Questionnaire', 'asthma control test (ACT', 'standard inhalant therapy']","['ACT scores', 'healthcare costs', 'erratic non-adherence', 'lung function indexes']","[{'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C4319602', 'cui_str': '27'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0034060', 'cui_str': 'Pulmonary medicine'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0302523', 'cui_str': 'Observation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4517706', 'cui_str': '312'}]","[{'cui': 'C0585302', 'cui_str': 'Once monthly'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C4048375', 'cui_str': 'Asthma control test'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0001559', 'cui_str': 'Inhaled drug administration'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C2733224', 'cui_str': 'Asthma control test score'}, {'cui': 'C0085552', 'cui_str': 'Health Costs'}, {'cui': 'C0376405', 'cui_str': 'Noncompliance with treatment'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",627.0,0.018218,"The TAI results indicated that adherence to inhalers of patients in the observation group was significantly better than that in control and the patients' non-adherence pattern in the observation group, with significantly lower erratic non-adherence, was also different from that in control.","[{'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': ""Department of Clinical Pharmacy, School of Pharmacy, Zunyi Medical University, Zunyi 563006, People's Republic of China.""}, {'ForeName': 'Chengchen', 'Initials': 'C', 'LastName': 'Yin', 'Affiliation': ""Department of Clinical Pharmacy, School of Pharmacy, Zunyi Medical University, Zunyi 563006, People's Republic of China.""}, {'ForeName': 'Hongfang', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': ""Department of Clinical Pharmacy, School of Pharmacy, Zunyi Medical University, Zunyi 563006, People's Republic of China.""}, {'ForeName': 'Weipeng', 'Initials': 'W', 'LastName': 'Wei', 'Affiliation': ""Department of Clinical Pharmacy, School of Pharmacy, Zunyi Medical University, Zunyi 563006, People's Republic of China.""}, {'ForeName': 'Yuansha', 'Initials': 'Y', 'LastName': 'Gong', 'Affiliation': ""School of Nursing, Zunyi Medical University, Zunyi 563006, People's Republic of China.""}, {'ForeName': 'Fushan', 'Initials': 'F', 'LastName': 'Tang', 'Affiliation': ""Department of Clinical Pharmacy, School of Pharmacy, Zunyi Medical University, Zunyi 563006, People's Republic of China.""}]",Patient preference and adherence,['10.2147/PPA.S176683'] 2588,32606635,Evaluation of Pectoral Nerve Block in Modified Radical Mastectomy: Comparison of Three Concentrations of Ropivacaine.,"Background Pectoral nerve block type I (PECS I Block) and type II (PECS II Block) with ropivacaine are relatively new analgesic methods for breast-cancer surgery. We evaluated the safety and efficacy of different concentrations of ropivacaine given in the same volume for the PECS II Block in patients undergoing modified radical mastectomy (MRM). Patients and Methods One hundred and twenty women undergoing elective MRM who met inclusion criteria were divided randomly into four groups of 30: control group without PECS II Block and R 0.2% , R 0.3% , and R 0.4% groups, who received general anesthesia plus the PECS II Block with ropivacaine at 0.2%, 0.3%, and 0.4%, respectively, in a volume of 40 mL. Results The postoperative numerical rating scale (NRS) pain score at rest and active was significantly higher in the control group than that in the three ropivacaine groups (P<0.05 for all), and the postoperative NRS score in the R 0.3% group and R 0.4% group at 12, 24, and 48 h postoperatively were significantly lower than that in the R 0.2% group (P<0.05 for all); there was no significant difference between the R 0.3% group and R 0.4% group. The time when pain was first felt after MRM, the total number of complaints during 3, 6, 12, 24, and 48 h after MRM, and the total analgesic requirement (tramadol consumption) during the first 24 h postoperatively in the R 0.3% group and R 0.4% group were significantly lower than those in the control group and R 0.2% group (P<0.05 for all); there was no significant difference between the R 0.3% group and R 0.4% group. Conclusion A dose of 0.3% ropivacaine was the optimal concentration for a PECS II Block for patients undergoing MRM because it provided efficacious analgesia during and >48 h after MRM. Increasing the ropivacaine concentration did not improve the analgesia of the PECS II Block significantly.",2020,Increasing the ropivacaine concentration did not improve the analgesia of the PECS II Block significantly.,"['Patients and Methods\n\n\nOne hundred and twenty women undergoing elective MRM who met inclusion criteria', 'breast-cancer surgery', 'patients undergoing modified radical mastectomy (MRM']","['Modified Radical Mastectomy', 'Pectoral Nerve Block', 'ropivacaine', 'control group without PECS II Block', 'PECS', 'general anesthesia plus the PECS II Block with ropivacaine', 'Ropivacaine', '\n\n\nPectoral nerve block type']","['total analgesic requirement (tramadol consumption', 'postoperative numerical rating scale (NRS) pain score at rest and active', 'total number of complaints', 'safety and efficacy', 'postoperative NRS score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0024883', 'cui_str': 'Modified radical mastectomy'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0024883', 'cui_str': 'Modified radical mastectomy'}, {'cui': 'C0205967', 'cui_str': 'Pectoral Nerves'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0073571', 'cui_str': 'ropivacaine'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4273496', 'cui_str': 'PECS II block'}, {'cui': 'C0055065', 'cui_str': 'CEP combination'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0040610', 'cui_str': 'Tramadol'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0443144', 'cui_str': 'At rest'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0277786', 'cui_str': 'Complaint'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",120.0,0.0495057,Increasing the ropivacaine concentration did not improve the analgesia of the PECS II Block significantly.,"[{'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Deng', 'Affiliation': ""Department of Anesthesiology, The First Hospital of Jiaxing (Affiliated Hospital of Jiaxing University), Jiaxing, People's Republic of China.""}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Fu', 'Affiliation': ""Department of Paediatrics, Affiliated Hospital of Guilin Medical University, Guilin, People's Republic of China.""}, {'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'He', 'Affiliation': ""Department of Anesthesiology, Affiliated Hospital of Guilin Medical University, Guilin, People's Republic of China.""}]",Clinical interventions in aging,['10.2147/CIA.S251613'] 2589,32606640,Critical Error Frequency and the Impact of Training with Inhalers Commonly used for Maintenance Treatment in Chronic Obstructive Pulmonary Disease.,"Introduction Training in correct inhaler use, ideally in person or by video demonstration, can minimize errors but is rarely provided in clinics. This open-label, low-intervention study evaluated critical error rates with dry-powder inhalers (DPIs), before and after training, in patients with chronic obstructive pulmonary disease. Methods Patients prescribed an inhaled corticosteroid (ICS)/long-acting β 2 -agonist (LABA) (ELLIPTA, Turbuhaler, or DISKUS), long-acting muscarinic antagonist (LAMA)/LABA (ELLIPTA or Breezhaler), or LAMA-only DPI (ELLIPTA, HandiHaler, or Breezhaler) were enrolled. Critical errors were assessed before training (Visit 1 [V1]; primary endpoint) and 6 weeks thereafter (Visit 2 [V2]; secondary endpoint). Logistic regression models were used to calculate odds ratios (ORs) for between-group comparisons. Results The intent-to-treat population comprised 450 patients. At V1, fewer patients made ≥1 critical error with ELLIPTA (10%) versus other ICS/LABA DPIs (Turbuhaler: 40%, OR 4.66, P =0.005; DISKUS: 26%, OR 2.48, P =0.114) and other LAMA or LAMA/LABA DPIs (HandiHaler: 34%, OR 3.50, P =0.026; Breezhaler: 33%, OR 3.94, P =0.012). Critical error rates with the primary ICS/LABA DPI were not significantly different between ELLIPTA ICS/LABA (10%) and ICS/LABA plus LAMA groups (12-25%). Critical errors with the primary ICS/LABA DPI occurred less frequently with ELLIPTA ICS/LABA with or without LAMA (11%) versus Turbuhaler ICS/LABA with or without LAMA (39%, OR 3.99, P <0.001) and DISKUS ICS/LABA with or without LAMA (26%, OR 2.18, P =0.069). Simulating single-inhaler versus multiple-inhaler triple therapy, critical error rates were lower with ELLIPTA fluticasone furoate/vilanterol (FF/VI; 10%) versus ELLIPTA FF/VI plus LAMA (22%), considering errors with either DPI (OR 2.50, P =0.108). At V2, critical error rates decreased for all DPIs/groups, reaching zero only for ELLIPTA. Between-group comparisons were similar to V1. Conclusion Fewer patients made critical errors with ELLIPTA versus other ICS/LABA, and LAMA or LAMA/LABA DPIs. The effect of ""verbal"" training highlights its importance for reducing critical errors with common DPIs.",2020,"LABA with or without LAMA (26%, OR 2.18, P =0.069).","['patients with chronic obstructive pulmonary disease', 'Chronic Obstructive Pulmonary Disease']","['ELLIPTA ICS/LABA', 'Training with Inhalers', 'primary ICS', 'inhaled corticosteroid', 'ELLIPTA fluticasone furoate/vilanterol', 'verbal"" training', 'ELLIPTA ICS', 'ICS)/long-acting β 2 -agonist (LABA) (ELLIPTA, Turbuhaler, or DISKUS), long-acting muscarinic antagonist (LAMA)/LABA (ELLIPTA or Breezhaler), or LAMA-only DPI (ELLIPTA, HandiHaler, or Breezhaler', 'dry-powder inhalers (DPIs', 'ELLIPTA FF/VI plus LAMA', 'ELLIPTA', 'LABA with or without LAMA']","['critical error rates', 'LABA DPI']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}]","[{'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0021461', 'cui_str': 'Inhaler'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1948374', 'cui_str': 'fluticasone furoate'}, {'cui': 'C2935023', 'cui_str': 'vilanterol'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0003385', 'cui_str': 'Muscarinic receptor antagonist'}, {'cui': 'C0999593', 'cui_str': 'Lama'}, {'cui': 'C1967611', 'cui_str': 'Dry powder inhaler'}, {'cui': 'C0332287', 'cui_str': 'With'}]",[],,0.0749442,"LABA with or without LAMA (26%, OR 2.18, P =0.069).","[{'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Collier', 'Affiliation': 'William Harvey Research Institute, Barts & The London School of Medicine & Dentistry, Queen Mary University of London, London, UK.'}, {'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Wielders', 'Affiliation': 'Department of Pulmonary Diseases, Catharina Hospital, Eindhoven, Netherlands.'}, {'ForeName': 'Job', 'Initials': 'J', 'LastName': 'van der Palen', 'Affiliation': 'Department of Pulmonology, Medisch Spectrum Twente, Enschede, Netherlands.'}, {'ForeName': 'Logan', 'Initials': 'L', 'LastName': 'Heyes', 'Affiliation': 'Respiratory Therapy Area Unit, GlaxoSmithKline Plc., Stockley Park, Uxbridge, UK.'}, {'ForeName': 'Dawn', 'Initials': 'D', 'LastName': 'Midwinter', 'Affiliation': 'Respiratory Therapy Area Unit, GlaxoSmithKline Plc., Stockley Park, Uxbridge, UK.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Collison', 'Affiliation': 'Respiratory Medical Franchise, GlaxoSmithKline Plc., Research Triangle Park, Durham, NC, USA.'}, {'ForeName': 'Andy', 'Initials': 'A', 'LastName': 'Preece', 'Affiliation': 'Respiratory Therapy Area Unit, GlaxoSmithKline Plc., Stockley Park, Uxbridge, UK.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Barnes', 'Affiliation': 'William Harvey Research Institute, Barts & The London School of Medicine & Dentistry, Queen Mary University of London, London, UK.'}, {'ForeName': 'Raj', 'Initials': 'R', 'LastName': 'Sharma', 'Affiliation': 'Respiratory Therapy Area Unit, GlaxoSmithKline Plc., Stockley Park, Uxbridge, UK.'}]",International journal of chronic obstructive pulmonary disease,['10.2147/COPD.S224209'] 2590,32606695,Safety and Efficacy of Centanafadine Sustained-Release in Adults With Attention-Deficit Hyperactivity Disorder: Results of Phase 2 Studies.,"Purpose Two phase 2 studies evaluated the efficacy and tolerability of centanafadine sustained-release (SR) for adults with attention-deficit/hyperactivity disorder (ADHD). Patients and Methods In a phase 2a, flexible-dose, single-blind study, 41 male patients (aged 18‒55 years) with a diagnosis of ADHD (based on Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition) were titrated with centanafadine-SR 200‒300, 400, or 500 mg/d for 2 weeks, and then were treated with the titrated dose for 2 weeks. In a phase 2b, randomized, double-blind, placebo-controlled, crossover study, 85 male and female patients (aged 18‒60 years) with a diagnosis of ADHD (Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition) were titrated to target doses of centanafadine-SR 400, 500, 600, or 800 mg/d over the course of 1 week, and then received their titrated dose for 3 weeks. The primary outcome in both studies was mean total ADHD Rating Scale-IV (ADHD-RS-IV) score. Results In the phase 2a study, mean ADHD-RS-IV total score decreased by 21.41 (standard deviation 10.74) from the start of active centanafadine-SR treatment to the end of week 4 ( P <0.001). In the phase 2b study, centanafadine-SR treatment resulted in a statistically significant improvement in ADHD-RS-IV from baseline to week 3 compared with placebo (least-squares mean -16.5 vs -8.4; P <0.001; effect size 0.66), with significant efficacy demonstrated as early as week 1. Centanafadine-SR was generally well tolerated at doses ≤400 mg. Most treatment-emergent adverse events (TEAEs) were mild or moderate; decreased appetite, headache, and nausea were the most frequently reported. In the 2 studies, 13 of 120 patients discontinued centanafadine-SR due to TEAEs; however, only 1 patient who received ≤400 mg discontinued due to a TEAE. No serious TEAEs were reported at any dose. Conclusion These results support the continued development of centanafadine-SR at doses up to 400 mg/d.",2020,"In the phase 2a study, mean ADHD-RS-IV total score decreased by 21.41 (standard deviation 10.74) from the start of active centanafadine-SR treatment to the end of week 4 ( P <0.001).","['adults with attention-deficit/hyperactivity disorder (ADHD', '85 male and female patients (aged 18‒60 years) with a diagnosis of ADHD (Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition', '41 male patients (aged 18‒55 years) with a diagnosis of ADHD (based on Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition', 'With Attention-Deficit Hyperactivity Disorder', 'Adults']","['Centanafadine-SR', 'Centanafadine', 'centanafadine sustained-release (SR', 'centanafadine-SR', 'placebo']","['ADHD-RS-IV', 'appetite, headache, and nausea', 'mean total ADHD Rating Scale-IV (ADHD-RS-IV) score', 'efficacy and tolerability', 'mean ADHD-RS-IV total score']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1136324', 'cui_str': 'Diagnostic and Statistical Manual of Mental Disorders'}, {'cui': 'C0205439', 'cui_str': 'Fifth'}, {'cui': 'C0441792', 'cui_str': 'Editions'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0441797', 'cui_str': 'Fourth edition'}]","[{'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}, {'cui': 'C0003618', 'cui_str': 'Food appetite'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",41.0,0.0501856,"In the phase 2a study, mean ADHD-RS-IV total score decreased by 21.41 (standard deviation 10.74) from the start of active centanafadine-SR treatment to the end of week 4 ( P <0.001).","[{'ForeName': 'Sharon B', 'Initials': 'SB', 'LastName': 'Wigal', 'Affiliation': 'AVIDA Inc., Newport Beach, California, USA.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Wigal', 'Affiliation': 'AVIDA Inc., Newport Beach, California, USA.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Hobart', 'Affiliation': 'Otsuka Pharmaceutical Development & Commercialization, Inc., Rockville, Maryland, USA.'}, {'ForeName': 'Jessica J', 'Initials': 'JJ', 'LastName': 'Madera', 'Affiliation': 'Otsuka Pharmaceutical Development & Commercialization, Inc., Princeton, New Jersey, USA.'}, {'ForeName': 'Ross A', 'Initials': 'RA', 'LastName': 'Baker', 'Affiliation': 'Otsuka Pharmaceutical Development & Commercialization, Inc., Princeton, New Jersey, USA.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Kohegyi', 'Affiliation': 'Otsuka Pharmaceutical Development & Commercialization, Inc., Princeton, New Jersey, USA.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'McKinney', 'Affiliation': 'Ethismos Research, Inc, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Timothy E', 'Initials': 'TE', 'LastName': 'Wilens', 'Affiliation': 'Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts, USA.'}]",Neuropsychiatric disease and treatment,['10.2147/NDT.S242084'] 2591,32606883,Sustained Corticosteroid-Free Clinical Remission During Vedolizumab Maintenance Therapy in Patients with Ulcerative Colitis on Stable Concomitant Corticosteroids During Induction Therapy: A Post Hoc Analysis of GEMINI 1.,"Background Corticosteroid-free clinical remission is important in ulcerative colitis. Objective This GEMINI 1 post hoc analysis evaluated vedolizumab efficacy in achieving sustained corticosteroid-free clinical remission in moderately to severely active ulcerative colitis. Materials and Methods GEMINI 1 included a 6-week induction period followed by a 46-week maintenance period. Patients received stable corticosteroid dosing at baseline/during induction and tapered dosing during maintenance. Analysis groups included vedolizumab (induction and maintenance); vedolizumab/placebo (vedolizumab induction, placebo maintenance); and placebo (induction and maintenance). The primary endpoint was sustained corticosteroid-free clinical remission (partial Mayo score ≤2, no individual subscore >1, for ≥32 weeks). Multivariate analyses identified covariates associated with the primary endpoint. Safety endpoints included adverse events. Results Baseline demographics and concomitant corticosteroid use were similar across groups (n=454). A greater proportion (95% confidence interval) of the vedolizumab group achieved sustained corticosteroid-free clinical remission (10.2% [6.9 to 13.6]) vs the placebo group (1.4% [0.0 to 7.3]; difference 8.9% [-3.8 to 21.4]). Proportions were similar between the vedolizumab/placebo and placebo groups. Covariates associated with sustained corticosteroid-free clinical remission (odds ratio [95% confidence interval]) were treatment (vedolizumab vs placebo: 9.35 [1.25 to 71.43]; p =0.0605), anti-tumor necrosis factor alpha exposure (yes vs no: 0.26 [0.12 to 0.57]; p =0.0008), and disease duration (≤2 vs >2 years: 2.66 [0.99-7.19]; p =0.0531). Adverse events were similar across groups. Conclusion A numerically greater proportion of vedolizumab-treated patients with ulcerative colitis achieved sustained corticosteroid-free clinical remission. Vedolizumab treatment, no previous anti-tumor necrosis factor alpha exposure, and shorter disease duration were associated with sustained corticosteroid-free clinical remission. Clinicaltrialsgov NCT00783718.",2020,A greater proportion (95% confidence interval) of the vedolizumab group achieved sustained corticosteroid-free clinical remission (10.2% [6.9 to 13.6]) vs the placebo group (1.4% [0.0 to 7.3]; difference 8.9% [-3.8 to 21.4]).,['Patients with Ulcerative Colitis on Stable Concomitant Corticosteroids'],"['Vedolizumab', 'placebo', 'vedolizumab', 'Induction Therapy', 'Vedolizumab Maintenance Therapy', 'stable corticosteroid', 'vedolizumab/placebo', 'vedolizumab (induction and maintenance); vedolizumab/placebo (vedolizumab induction, placebo maintenance); and placebo (induction and maintenance']","['Adverse events', 'sustained corticosteroid-free clinical remission', 'disease duration', 'sustained corticosteroid-free clinical remission (partial Mayo score ≤2, no individual subscore', 'adverse events', 'vedolizumab efficacy', 'anti-tumor necrosis factor alpha exposure']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009324', 'cui_str': 'Ulcerative colitis'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}]","[{'cui': 'C2742797', 'cui_str': 'vedolizumab'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0677908', 'cui_str': 'Maintenance therapy'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0454788', 'cui_str': 'Mayo'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C2742797', 'cui_str': 'vedolizumab'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C1168005', 'cui_str': 'Alpha tumour necrosis factor'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}]",,0.584942,A greater proportion (95% confidence interval) of the vedolizumab group achieved sustained corticosteroid-free clinical remission (10.2% [6.9 to 13.6]) vs the placebo group (1.4% [0.0 to 7.3]; difference 8.9% [-3.8 to 21.4]).,"[{'ForeName': 'Edward V', 'Initials': 'EV', 'LastName': 'Loftus', 'Affiliation': 'Division of Gastroenterology and Hepatology, Mayo Clinic College of Medicine, Rochester, MN, USA.'}, {'ForeName': 'Bruce E', 'Initials': 'BE', 'LastName': 'Sands', 'Affiliation': 'The Dr. Henry D. Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai Hospital, New York, NY, USA.'}, {'ForeName': 'Jean-Frédéric', 'Initials': 'JF', 'LastName': 'Colombel', 'Affiliation': 'The Dr. Henry D. Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai Hospital, New York, NY, USA.'}, {'ForeName': 'Iris', 'Initials': 'I', 'LastName': 'Dotan', 'Affiliation': 'Division of Gastroenterology, Rabin Medical Center, Petah Tikva, Israel, and the Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Javaria Mona', 'Initials': 'JM', 'LastName': 'Khalid', 'Affiliation': 'Takeda International - UK Branch, London, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Tudor', 'Affiliation': 'Takeda Pharmaceuticals International AG, Zurich, Switzerland.'}, {'ForeName': 'Parnia', 'Initials': 'P', 'LastName': 'Geransar', 'Affiliation': 'Takeda Pharmaceuticals International AG, Zurich, Switzerland.'}]",Clinical and experimental gastroenterology,['10.2147/CEG.S248597'] 2592,32606899,"Low-Intensity Continuous Ultrasound for the Symptomatic Treatment of Upper Shoulder and Neck Pain: A Randomized, Double-Blind Placebo-Controlled Clinical Trial.","Purpose Low-intensity continuous ultrasound (LICUS) is an emerging high-dosimetry ultrasound-based therapy for accelerated tissue healing and the treatment of myofascial pain. In this study, LICUS treatment is clinically evaluated for chronic upper neck and shoulder pain in a randomized, multi-site, double-blind, placebo-controlled study. Patients and Methods CONSORT guidelines were followed in conducting and reporting the clinical trial. Thirty-three participants with upper trapezius myofascial pain were randomized for treatment with active (n=25) or placebo (n=8) devices. Investigators and subjects were blinded to treatment groups. Participants self-reported pain daily, rating from 0-10 on the numeric rating scale. If pain rating was more significant than or equal to 3, the LICUS (3MHz, 0.132W/cm 2 , 1.3W, 4 hours) was self-applied for total energy dosimetry of 18,720 Joules per treatment. During the 4-week study, daily pain rating was recorded. If LICUS treatment was delivered, pain before, during, and after treatment were recorded as well as the global rate of change (GROC). Independent t -tests were used to assess change from baseline and differences between treatment groups. ClinicalTrials.gov: NCT02135094. Results There was a 100% completion rate for participants enrolled in the study and no significant differences between the groups regarding demographic variables or baseline outcome measures. Participants treated with active therapy observed a significant mean pain reduction from baseline of 2.61 points for active (p<0.001), compared to 1.58 points decrease from baseline for placebo (p=0.087), resulting in a 1.03 points significant decrease in the active group over placebo (p=0.003). The total GROC was significantly higher in the active group at 2.84 points compared to the placebo group at 0.46 points (p<0.001). Conclusion Low-intensity continuous ultrasound treatment significantly reduced pain in patients with upper trapezius myofascial pain of the neck and shoulder. LICUS treatment showed a clinically meaningful improvement in the GROC scores for patients. The results from this clinical trial indicate that the LICUS treatment of 18,720 Joules can effectively be used to treat clinical pain related to upper trapezius myofascial pain. Further research could investigate varying dosimetry to improve efficacy and/or reduce the dose.",2020,There was a 100% completion rate for participants enrolled in the study and no significant differences between the groups regarding demographic variables or baseline outcome measures.,"['Upper Shoulder and Neck Pain', 'patients with upper trapezius myofascial pain of the neck and shoulder', 'Thirty-three participants with upper trapezius myofascial pain']","['Placebo', 'Low-intensity continuous ultrasound (LICUS', 'LICUS', 'Low-Intensity Continuous Ultrasound', 'placebo']","['total GROC', 'global rate of change (GROC', 'GROC scores', 'pain', 'pain rating', 'mean pain reduction', 'chronic upper neck and shoulder pain', 'daily pain rating']","[{'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0007859', 'cui_str': 'Neck pain'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0224361', 'cui_str': 'Structure of trapezius muscle'}, {'cui': 'C0553642', 'cui_str': 'Myofascial pain'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0450358', 'cui_str': '33'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0596836', 'cui_str': 'Light intensity'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0037011', 'cui_str': 'Shoulder pain'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]",33.0,0.547509,There was a 100% completion rate for participants enrolled in the study and no significant differences between the groups regarding demographic variables or baseline outcome measures.,"[{'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Petterson', 'Affiliation': 'Orthopaedic Foundation, Stamford, CT, USA.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Plancher', 'Affiliation': 'Plancher Orthopaedics & Sports Medicine, New York, NY 10128, USA.'}, {'ForeName': 'Dominic', 'Initials': 'D', 'LastName': 'Klyve', 'Affiliation': 'Department of Mathematics, Central Washington University, Ellensburg, WI, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Draper', 'Affiliation': 'Department of Exercise Sciences, Brigham Young University, Provo, UT, USA.'}, {'ForeName': 'Ralph', 'Initials': 'R', 'LastName': 'Ortiz', 'Affiliation': 'Medical Pain Consultants, Dryden, NY, USA.'}]",Journal of pain research,['10.2147/JPR.S247463'] 2593,32606902,"A Randomized, Crossover, Pharmacokinetic and Adhesion Performance Study of a Lidocaine Topical System 1.8% During Physical Activity and Heat Treatment in Healthy Subjects.","Purpose This study compares the pharmacokinetic (PK) profile, adhesion, and safety of lidocaine topical system 1.8%, a novel lidocaine topical system approved to treat postherpetic neuralgia, under conditions of heat and exercise vs normal conditions. Materials and Methods This open-label, 3-period, 3-treatment crossover study randomized 12 healthy adults to receive three lidocaine topical systems 1.8% during each of three treatment periods, with 7-day washouts between treatments. The product was applied to the mid-lower back and was removed after 12 hours. During Treatment A, subjects exercised on a bicycle for 30 minutes at 0, 2.5, 5.5, and 8.5 hours. During Treatment B, heat (temperature set at 36.7-40.3°C) was applied at 0 and 8.5 hours. Treatment C was normal conditions. The PK profile of each subject under exercise and heat conditions was compared to normal conditions. Skin irritation, adhesion, and adverse events were assessed. Results Twelve subjects completed the study. Exposure to external heat resulted in increased peak plasma concentration of lidocaine with a mean C max of 160.3±100.1 ng/mL vs 97.6±36.9 ng/mL under normal conditions, with no effect on the extent of exposure (AUC). Concentrations returned to normal within 4 hours after the heat was removed. No clinically relevant differences in absorption were observed under exercise conditions with a mean C max of 90.5±25.4 ng/mL and no effect on the extent (AUC) of lidocaine exposure was observed relative to normal conditions. No systems detached during the study. Adverse events were mild, with none leading to discontinuation. Conclusion Transient heat exposure resulted in increased lidocaine plasma concentrations compared to normal conditions, whereas exercise had no effect. The effects of heat appear to be immediate, reversible, and below systemic therapeutic threshold in antiarrhythmic treatment (1000-1500 ng/mL), and well below the safe systemic threshold of 5000 ng/mL. Lidocaine topical system 1.8% remained adhered to the skin and was well tolerated under all conditions. ClinicalTrials.gov: NCT04150536.",2020,Exposure to external heat resulted in increased peak plasma concentration of lidocaine with a mean C max of 160.3±100.1,"['Healthy Subjects', '12 healthy adults']","['Lidocaine Topical System 1.8', 'lidocaine topical systems', 'lidocaine', 'lidocaine topical system']","['Adverse events', 'Skin irritation, adhesion, and adverse events', 'peak plasma concentration', 'extent of exposure (AUC', 'pharmacokinetic (PK) profile, adhesion, and safety', 'lidocaine plasma concentrations']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C0360097', 'cui_str': 'Lidocaine-containing product in cutaneous dose form'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C4068742', 'cui_str': '1.8'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0152030', 'cui_str': 'Skin irritation'}, {'cui': 'C0001511', 'cui_str': 'Adhesion'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0439792', 'cui_str': 'Extent'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}]",12.0,0.0345779,Exposure to external heat resulted in increased peak plasma concentration of lidocaine with a mean C max of 160.3±100.1,"[{'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Fudin', 'Affiliation': 'Samuel Stratton Department of Veterans Affairs Medical Center, Albany, NY, USA.'}, {'ForeName': 'Erica L', 'Initials': 'EL', 'LastName': 'Wegrzyn', 'Affiliation': 'Samuel Stratton Department of Veterans Affairs Medical Center, Albany, NY, USA.'}, {'ForeName': 'Emileigh', 'Initials': 'E', 'LastName': 'Greuber', 'Affiliation': 'Scilex Pharmaceuticals Inc., Mountain View, CA, USA.'}, {'ForeName': 'Kip', 'Initials': 'K', 'LastName': 'Vought', 'Affiliation': 'Scilex Pharmaceuticals Inc., Mountain View, CA, USA.'}, {'ForeName': 'Kalpana', 'Initials': 'K', 'LastName': 'Patel', 'Affiliation': 'Scilex Pharmaceuticals Inc., Mountain View, CA, USA.'}, {'ForeName': 'Sri', 'Initials': 'S', 'LastName': 'Nalamachu', 'Affiliation': 'Mid America PolyClinic, Overland Park, KS, USA.'}]",Journal of pain research,['10.2147/JPR.S238268'] 2594,32606903,Nalbuphine versus Midazolam as an Adjuvant to Intrathecal Bupivacaine for Postoperative Analgesia in Patients Undergoing Cesarean Section.,"Background and Purpose Adding adjuvants to intrathecal hyperbaric bupivacaine provides long analgesic duration with less adverse effects. The aim of this study was to compare intrathecal nalbuphine versus midazolam in patients undergoing cesarean section. Clinical Trial ID NCT03918187. Patients and Methods This was a prospective randomized controlled study conducted on 90 females undergoing cesarean section under spinal anesthesia who were randomly allocated to three equal groups of 30 patients each: group C received hyperbaric bupivacaine 12.5 mg plus 0.5 mL saline, group N received hyperbaric bupivacaine 12.5 mg plus 1 mg nalbuphine, group M received hyperbaric bupivacaine 12.5 mg plus 2.5 mg midazolam. The onset and duration of sensory and motor block, effective analgesic time, analgesic requirements, adverse effects, sedation, and Apgar scores were recorded. Results There was significant rapid onset of sensory and motor block (1.95±.44 and 3.50±0.43 min) with slower regression of sensory block and time to bromage I (211.6±13.2 and 219.8±20.2 min) in group N compared to groups M, C (p < 0.001), with statistically significant rapid onset and long duration of both blocks in group M compared to C (p<0.001). The effective analgesic time was significantly prolonged in group N (263.7±16.3) compared to groups M and C (224.2 ± 18.6, 185.5±17.45), respectively, (p<0.001) and prolonged in group M compared to C (p<0.001), with increase in analgesic requirement in group C compared to groups N and M (p<0.001) and no significant difference between groups N and M. There was higher sedation score in groups N, M (1.78±0.63, 2.75±0.54), respectively, compared to group C (0.61±0.12) (p<0.001) with lower Apgar score in group M (6.9±0.73) at one minute than in groups N, C (7.1±0.91, 7.7±0.84) (p<0.001). There was no significant difference between groups regarding the adverse effects. Conclusion Adding 1 mg nalbuphine to 12.5 mg hyperbaric bupivacaine provided more effective postoperative analgesia than adding 2.5 mg midazolam, with less non-significant adverse effects in midazolam group in patients undergoing elective cesarean section.",2020,"The effective analgesic time was significantly prolonged in group N (263.7±16.3) compared to groups M and C (224.2 ± 18.6, 185.5±17.45), respectively, (p<0.001) and prolonged in group M compared to C (p<0.001), with increase in analgesic requirement in group C compared to groups N and M (p<0.001) and no significant difference between groups N and M.","['patients undergoing elective cesarean section', 'Patients Undergoing Cesarean Section', '90 females undergoing cesarean section under spinal anesthesia', 'patients undergoing cesarean section']","['Nalbuphine versus Midazolam', 'nalbuphine', 'intrathecal nalbuphine versus midazolam', 'intrathecal hyperbaric bupivacaine', 'hyperbaric bupivacaine 12.5 mg plus 1 mg nalbuphine', 'hyperbaric bupivacaine', 'hyperbaric bupivacaine 12.5 mg plus 0.5 mL saline', 'midazolam', 'Intrathecal Bupivacaine', 'hyperbaric bupivacaine 12.5 mg plus 2.5 mg midazolam']","['onset and duration of sensory and motor block, effective analgesic time, analgesic requirements, adverse effects, sedation, and Apgar scores', 'rapid onset of sensory and motor block', 'effective postoperative analgesia', 'sensory block and time to bromage I', 'higher sedation score', 'effective analgesic time', 'adverse effects', 'analgesic requirement']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0473296', 'cui_str': 'Elective cesarean section'}, {'cui': 'C0007876', 'cui_str': 'Cesarean section'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0002928', 'cui_str': 'Spinal anesthesia'}]","[{'cui': 'C0027348', 'cui_str': 'Nalbuphine'}, {'cui': 'C0026056', 'cui_str': 'Midazolam'}, {'cui': 'C0677897', 'cui_str': 'Intrathecal route'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C4517544', 'cui_str': '12.5'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C3844011', 'cui_str': '2.5'}]","[{'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0445254', 'cui_str': 'Sensory'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0235195', 'cui_str': 'Sedated'}, {'cui': 'C0003533', 'cui_str': 'Finding of Apgar score'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0332162', 'cui_str': 'Onset of'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",90.0,0.232254,"The effective analgesic time was significantly prolonged in group N (263.7±16.3) compared to groups M and C (224.2 ± 18.6, 185.5±17.45), respectively, (p<0.001) and prolonged in group M compared to C (p<0.001), with increase in analgesic requirement in group C compared to groups N and M (p<0.001) and no significant difference between groups N and M.","[{'ForeName': 'Olfat Abdelmoniem Ibrahem', 'Initials': 'OAI', 'LastName': 'Amin', 'Affiliation': 'Anesthesia and Surgical Intensive Care Department, Faculty of Medicine, Zagazig University, Alsharkia, Egypt.'}, {'ForeName': 'Mohamed Abdel-Moniem', 'Initials': 'MA', 'LastName': 'Ibrahem', 'Affiliation': 'Obstetrics and Gynecology Department, Faculty of Medicine, Zagazig University, Alsharkia, Egypt.'}, {'ForeName': 'Dina Abdelhameed Elsadek', 'Initials': 'DAE', 'LastName': 'Salem', 'Affiliation': 'Anesthesia and Surgical Intensive Care Department, Faculty of Medicine, Zagazig University, Alsharkia, Egypt.'}]",Journal of pain research,['10.2147/JPR.S242545'] 2595,32607066,A Topical Adhesive Containing Anesthetic and Heating Components to Reduce Injection Pain with Subcutaneous Multiple Sclerosis Medications: A Pilot Study.,"Background Injection pain and fear of pain are common with subcutaneous medications for treating multiple sclerosis (MS). Synera is a peel-and-stick topical adhesive (S-TA) with a novel heating component to enhance the delivery of an anesthetic mixture of lidocaine and tetracaine. We studied the effect of S-TA on pain and other aspects of comfort after subcutaneous MS drug injection. Methods Thirty participants with MS having injection reactions to subcutaneous interferon beta (IFNβ) or glatiramer acetate (GA) were enrolled in an open-label prospective study. We captured six to seven injections at baseline and with 60- and 30-minute S-TA application times. The primary outcome was immediate pain on injection. Secondary outcomes included 12- and 24-hour pain ratings, 24-hour local injection-site reaction scale scores, 24-hour tenderness, and fear of injection (FOI). Results Twenty-nine participants completed the study (interferon beta = 4, GA = 25, mean age = 51 years, females = 86%). There were significant reductions in injection pain, pain at 12 and 24 hours, tenderness at 24 hours, local injection-site reaction scale scores, and FOI for the 30- and 60-minute applications of S-TA (all P < .01). Results were similar in the GA subgroup. Adverse events included muscle spasm and lightheadedness (n = 1) and mild dermatitis (n = 1). Conclusions These results suggest that S-TA applied 30 or 60 minutes before MS drug injection may reduce pain, tenderness, and FOI. Randomized controlled studies are needed to confirm the efficacy of ST-A.",2017,"There were significant reductions in injection pain, pain at 12 and 24 hours, tenderness at 24 hours, local injection-site reaction scale scores, and FOI for the 30- and 60-minute applications of S-TA (all P < .01).","['Thirty participants with MS having injection reactions to', 'Results\n\n\nTwenty-nine participants completed the study (interferon beta = 4, GA = 25, mean age = 51 years, females = 86']","['S-TA', 'lidocaine and tetracaine', 'subcutaneous interferon beta (IFNβ) or glatiramer acetate (GA']","['Injection Pain', '12- and 24-hour pain ratings, 24-hour local injection-site reaction scale scores, 24-hour tenderness, and fear of injection (FOI', 'injection pain, pain at 12 and 24 hours, tenderness at 24 hours, local injection-site reaction scale scores, and FOI', 'pain, tenderness, and FOI', 'muscle spasm and lightheadedness (n = 1) and mild dermatitis', 'immediate pain on injection']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0450351', 'cui_str': '29'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0015980', 'cui_str': 'Interferon-beta'}, {'cui': 'C0000975', 'cui_str': 'Acetate'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C1706582', 'cui_str': 'Stick'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0001516', 'cui_str': 'Adhesive'}, {'cui': 'C1628498', 'cui_str': 'Lidocaine- and tetracaine-containing product'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0015980', 'cui_str': 'Interferon-beta'}, {'cui': 'C0000975', 'cui_str': 'Acetate'}, {'cui': 'C0289884', 'cui_str': 'glatiramer acetate'}]","[{'cui': 'C1096717', 'cui_str': 'Pain during injection'}, {'cui': 'C0439584', 'cui_str': '24 hours'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0151735', 'cui_str': 'Injection site reaction'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0234233', 'cui_str': 'Soreness'}, {'cui': 'C0424187', 'cui_str': 'Fear of needles'}, {'cui': 'C0086325', 'cui_str': 'Foy'}, {'cui': 'C0037763', 'cui_str': 'Spasm'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0011603', 'cui_str': 'Dermatitis'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}]",30.0,0.0781548,"There were significant reductions in injection pain, pain at 12 and 24 hours, tenderness at 24 hours, local injection-site reaction scale scores, and FOI for the 30- and 60-minute applications of S-TA (all P < .01).","[{'ForeName': 'Theodore R', 'Initials': 'TR', 'LastName': 'Brown', 'Affiliation': ''}, {'ForeName': 'Virginia I', 'Initials': 'VI', 'LastName': 'Simnad', 'Affiliation': ''}]",International journal of MS care,['10.7224/1537-2073.2015-099'] 2596,32607081,Residual Right Coronary Artery Stenosis after Left Main Coronary Artery Intervention Increased the 30-Day Cardiovascular Death and 3-Year Right Coronary Artery Revascularization Rate.,"Background The outcomes of patients with concomitant left main coronary artery (LMCA) and right coronary artery (RCA) diseases are reportedly worse than those with only LMCA disease. To date, only few studies have investigated the clinical impact of percutaneous coronary intervention (PCI) on RCA stenosis during the same hospitalization, in which LMCA disease was treated. This study was aimed at comparing the outcomes between patients with and without right coronary artery intervention during the same hospital course for LMCA intervention. Methods and Results From a total of 776 patients who were undergoing PCI to treat LMCA disease, 235 patients with concomitant RCA significant stenosis (more than 70% stenosis) were enrolled. The patients were divided into two groups: 174 patients received concomitant PCI for RCA stenosis during the same hospitalization, in which LMCA disease was treated, and 61 patients did not receive PCI for RCA stenosis. Patients without intervention to the right coronary artery had higher 30-day cardiovascular mortality rates and 3-year RCA revascularization rates compared to those with right coronary artery intervention. Patients without RCA intervention at the same hospitalization did not increase the 30-day total death, 3-year myocardial infarction rate, 3-year cardiovascular death, and 3-year total death. Conclusions In patients with LM disease and concomitant above or equal to 70% RCA stenosis, PCI for RCA lesion during the same hospitalization is recommended to reduce the 30-day cardiovascular death and 3-year RCA revascularization rate.",2020,Patients without intervention to the right coronary artery had higher 30-day cardiovascular mortality rates and 3-year RCA revascularization rates compared to those with right coronary artery intervention.,"['776 patients who were undergoing PCI to treat LMCA disease, 235 patients with concomitant RCA significant stenosis (more than 70% stenosis) were enrolled', 'patients with concomitant left main coronary artery (LMCA) and right coronary artery (RCA) diseases are reportedly worse than those with only LMCA disease', 'patients with and without right coronary artery intervention during the same hospital course for LMCA intervention']","['percutaneous coronary intervention (PCI', 'concomitant PCI for RCA stenosis', 'RCA intervention']","['30-day cardiovascular mortality rates and 3-year RCA revascularization rates', '30-day cardiovascular death and 3-year RCA revascularization rate', '30-day total death, 3-year myocardial infarction rate, 3-year cardiovascular death, and 3-year total death', '30-Day Cardiovascular Death and 3-Year Right Coronary Artery Revascularization Rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C1261316', 'cui_str': 'Right coronary artery structure'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0678234', 'cui_str': 'Form of stenosis'}, {'cui': 'C0439093', 'cui_str': '>'}, {'cui': 'C1261082', 'cui_str': 'Left coronary artery structure'}, {'cui': 'C0205042', 'cui_str': 'Coronary artery structure'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0750729', 'cui_str': 'Courses'}]","[{'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C3267166', 'cui_str': 'Right coronary artery stenosis'}, {'cui': 'C1261316', 'cui_str': 'Right coronary artery structure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1261316', 'cui_str': 'Right coronary artery structure'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}]",776.0,0.0310231,Patients without intervention to the right coronary artery had higher 30-day cardiovascular mortality rates and 3-year RCA revascularization rates compared to those with right coronary artery intervention.,"[{'ForeName': 'Chien-Ho', 'Initials': 'CH', 'LastName': 'Lee', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Chang Gung Memorial Hospital, Kaohsiung, Taiwan.'}, {'ForeName': 'Shaur-Zheng', 'Initials': 'SZ', 'LastName': 'Chong', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Chang Gung Memorial Hospital, Kaohsiung, Taiwan.'}, {'ForeName': 'Shu-Kai', 'Initials': 'SK', 'LastName': 'Hsueh', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Chang Gung Memorial Hospital, Kaohsiung, Taiwan.'}, {'ForeName': 'Wen-Jung', 'Initials': 'WJ', 'LastName': 'Chung', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Chang Gung Memorial Hospital, Kaohsiung, Taiwan.'}, {'ForeName': 'Cheng-I', 'Initials': 'CI', 'LastName': 'Cheng', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine, Chang Gung Memorial Hospital, Kaohsiung, Taiwan.'}]",Journal of interventional cardiology,['10.1155/2020/4587414'] 2597,32607084,"Kratom and Pain Tolerance: A Randomized, Placebo-Controlled, Double-Blind Study.","Background : Kratom has a long history of traditional medicine use in Southeast Asia. Consumption of kratom products has also been reported in the US and other regions of the world. Pain relief is among many self-reported kratom effects but have not been evaluated in controlled human subject research. Methods : Kratom effects on pain tolerance were assessed in a randomized, placebo-controlled, double-blind study. During a 1-day inpatient stay, participants received a randomized sequence of kratom and placebo decoctions matched for taste and appearance. Pain tolerance was measured objectively in a cold pressor task (CPT) as time (seconds) between the pain onset and the hand withdrawal from the ice bath. Health status, vital signs, objective, and subjective indicators of withdrawal symptoms, self-reported data on lifetime kratom use patterns, and assessments of blinding procedures were also evaluated. Results : Twenty-six males with the mean (SD) age 24.3 (3.4) years were enrolled. They reported the mean (SD) 6.1 (3.2) years of daily kratom consumption. Pain tolerance increased significantly 1 hour after kratom ingestion from the mean (SD) 11.2 (6.7) seconds immediately before to 24.9 (39.4) seconds 1 hour after kratom consumption (F(2,53.7)=4.33, p=0.02). Pain tolerance was unchanged after consuming placebo drinks: 15.0 (19.0) seconds immediately before and 12.0 (8.1) seconds 1 hour after consumption of placebo (F(2,52.8)=0.93, p=0.40). No discomfort or signs of withdrawal were reported or observed during 10-20 hours of kratom discontinuation. Conclusions : Kratom decoction demonstrated a substantial and statistically significant increase in pain tolerance. Further rigorous research on kratom pain-relieving properties and a safety profile is needed.",2020,"Pain tolerance increased significantly 1 hour after kratom ingestion from the mean (SD) 11.2 (6.7) seconds immediately before to 24.9 (39.4) seconds 1 hour after kratom consumption (F(2,53.7)=4.33, p=0.02).",['Twenty-six males with the mean (SD) age 24.3 (3.4) years were enrolled'],"[' ', 'Placebo', 'Kratom decoction', 'kratom and placebo decoctions', 'placebo']","['Kratom and Pain Tolerance', 'discomfort or signs of withdrawal', 'Pain relief', 'Health status, vital signs, objective, and subjective indicators of withdrawal symptoms, self-reported data on lifetime kratom use patterns, and assessments of blinding procedures', 'pain tolerance', 'Pain tolerance']","[{'cui': 'C0450349', 'cui_str': '26'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517692', 'cui_str': '3.4'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1197867', 'cui_str': 'Kratom'}]","[{'cui': 'C1197867', 'cui_str': 'Kratom'}, {'cui': 'C0162703', 'cui_str': 'Pain threshold'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0087169', 'cui_str': 'Withdrawal symptom'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0025664', 'cui_str': 'methods'}]",26.0,0.449845,"Pain tolerance increased significantly 1 hour after kratom ingestion from the mean (SD) 11.2 (6.7) seconds immediately before to 24.9 (39.4) seconds 1 hour after kratom consumption (F(2,53.7)=4.33, p=0.02).","[{'ForeName': 'Balasingam', 'Initials': 'B', 'LastName': 'Vicknasingam', 'Affiliation': 'Centre for Drug Research, Universiti Sains Malaysia, Penang, Malaysia.'}, {'ForeName': 'Weng Tink', 'Initials': 'WT', 'LastName': 'Chooi', 'Affiliation': 'School of Social Sciences, Universiti Sains Malaysia, Penang, Malaysia.'}, {'ForeName': 'Azlan Abdul', 'Initials': 'AA', 'LastName': 'Rahim', 'Affiliation': 'Centre for Drug Research, Universiti Sains Malaysia, Penang, Malaysia.'}, {'ForeName': 'Dinesh', 'Initials': 'D', 'LastName': 'Ramachandram', 'Affiliation': 'Centre for Drug Research, Universiti Sains Malaysia, Penang, Malaysia.'}, {'ForeName': 'Darshan', 'Initials': 'D', 'LastName': 'Singh', 'Affiliation': 'Centre for Drug Research, Universiti Sains Malaysia, Penang, Malaysia.'}, {'ForeName': 'Surash', 'Initials': 'S', 'LastName': 'Ramanathan', 'Affiliation': 'Centre for Drug Research, Universiti Sains Malaysia, Penang, Malaysia.'}, {'ForeName': 'Nur Sabrina Mohd', 'Initials': 'NSM', 'LastName': 'Yusof', 'Affiliation': 'Centre for Drug Research, Universiti Sains Malaysia, Penang, Malaysia.'}, {'ForeName': 'Hadzliana', 'Initials': 'H', 'LastName': 'Zainal', 'Affiliation': 'School of Pharmaceutical Sciences, Universiti Sains Malaysia, Penang, Malaysia.'}, {'ForeName': 'Vikneswaran', 'Initials': 'V', 'LastName': 'Murugaiyah', 'Affiliation': 'School of Pharmaceutical Sciences, Universiti Sains Malaysia, Penang, Malaysia.'}, {'ForeName': 'Ralitza', 'Initials': 'R', 'LastName': 'Gueorguieva', 'Affiliation': 'Yale School of Public Health, Department of Biostatistics, and Yale School of Medicine, Department of Psychiatry, New Haven, CT.'}, {'ForeName': 'Sharif Mahsufi', 'Initials': 'SM', 'LastName': 'Mansor', 'Affiliation': 'Centre for Drug Research, Universiti Sains Malaysia, Penang, Malaysia.'}, {'ForeName': 'Marek C', 'Initials': 'MC', 'LastName': 'Chawarski', 'Affiliation': 'Yale School of Medicine, Departments of Psychiatry and Emergency Medicine, New Haven, CT.'}]",The Yale journal of biology and medicine,[] 2598,32607114,Effect of Nebulized Verapamil on Oxygenation in Chronic Obstructive Pulmonary Disease (COPD) Patients Admitted to the Intensive Care Unit.,"Background Many pharmacological and behavioral therapies have been investigated to improve oxygenation in the intensive care unit (ICU). In patients with chronic obstructive pulmonary disease (COPD), the purpose of therapy is to correct the ventilation perfusion (V/Q) mismatch. Agents, such as calcium blockers, can affect both ventilation and vasculature. The inhalation route allows a more rapid achievement of therapeutic effects with few systemic side effects. Therefore, the present study aimed to investigate the effect of nebulized verapamil on oxygenation in COPD patients. Materials and Methods In this double-blind, randomized clinical trial, twenty hypoxic COPD patients, admitted to ICU, were treated with 10 mg of verapamil twice daily for three days. Also, twenty patients with COPD, who were matched in terms of age, sex, and severity of the disease, were enrolled in the control group and received nebulized normal saline. The oxygenation parameters were compared using an arterial blood gas (ABG) test before and after the intervention. Results The mean oxygen saturation was 91.2%±12.15 before verapamil inhalation, which increased to 95.75%±14.57 after receiving nebulized verapamil (P<0.05). Also, correction of blood pH, blood oxygen pressure, and oxygen ratio (PaO 2 /FIO 2 ) were higher in patients receiving verapamil, compared to the control group. The length of hospital stay was similar in the two groups. During the first three days, 30% of patients in the verapamil group and 20% of patients in the control group were intubated. Conclusion Our results indicated that verapamil inhalation increased oxygen saturation and accelerated extubation in patients with COPD.",2019,The length of hospital stay was similar in the two groups.,"['COPD patients', 'Chronic Obstructive Pulmonary Disease (COPD) Patients Admitted to the Intensive Care Unit', 'patients with COPD', 'twenty hypoxic COPD patients, admitted to ICU', 'patients with chronic obstructive pulmonary disease (COPD', 'twenty patients with COPD, who were matched in terms of age, sex, and severity of the disease']","['nebulized verapamil', 'nebulized normal saline', 'verapamil', 'verapamil inhalation', 'Nebulized Verapamil']","['correction of blood pH, blood oxygen pressure, and oxygen ratio (PaO 2 /FIO 2 ', 'mean oxygen saturation', 'length of hospital stay', 'arterial blood gas (ABG) test', 'intubated', 'oxygen saturation and accelerated extubation']","[{'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0583239', 'cui_str': 'Admission to intensive care unit'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0042523', 'cui_str': 'Verapamil'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}]","[{'cui': 'C0853363', 'cui_str': 'Blood pH'}, {'cui': 'C1291013', 'cui_str': 'Blood oxygen pressure'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0232555', 'cui_str': 'Peak gastric acid output'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0523807', 'cui_str': 'Oxygen saturation measurement'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0150411', 'cui_str': 'Analysis of arterial blood gases and pH'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0553891', 'cui_str': 'Extubation of trachea'}]",20.0,0.0597172,The length of hospital stay was similar in the two groups.,"[{'ForeName': 'Guitti', 'Initials': 'G', 'LastName': 'Pourdowlat', 'Affiliation': 'Chronic Respiratory Diseases Research Center, National Research Institute of Tuberculosis and Lung Disease (NRITLD), Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Alizade Kashani', 'Affiliation': 'Chronic Respiratory Diseases Research Center, National Research Institute of Tuberculosis and Lung Disease (NRITLD), Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Fariba', 'Initials': 'F', 'LastName': 'Ghorbani', 'Affiliation': 'Tracheal Diseases Research Center, (NRITLD), Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Shadi', 'Initials': 'S', 'LastName': 'Baniasadi', 'Affiliation': 'Tracheal Diseases Research Center, (NRITLD), Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Hamidreza', 'Initials': 'H', 'LastName': 'Jamaati', 'Affiliation': 'Chronic Respiratory Diseases Research Center, National Research Institute of Tuberculosis and Lung Disease (NRITLD), Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Behrooz', 'Initials': 'B', 'LastName': 'Farzanegan', 'Affiliation': 'Critical Care Quality Improvement Research Center, Shahid Modarres Hospital, Department of Anesthesiology, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}]",Tanaffos,[] 2599,32613244,Vacuum-formed retainers and bonded retainers for dental stabilization-a randomized controlled trial. Part II: patients' perceptions 6 and 18 months after orthodontic treatment.,"OBJECTIVE To compare removable vacuum-formed Essix C retainers with bonded cuspid-to-cuspid retainers (CTCs) regarding patients' perceptions after debonding and 6 and 18 months of retention. TRIAL DESIGN A single-centre two-arm parallel-group randomized controlled trial. METHODS This trial included 104 adolescent patients, computer-generated randomized, with sequentially numbered, opaque and sealed envelopes, into two groups and stratified by gender. They were treated with fixed appliances with and without tooth extractions in both jaws and were ready for debond. Patients in the intervention arm received a vacuum-formed retainer (VFR) in the mandible (n = 52), and patients in the active comparator arm received a CTC (n = 52). Both groups had a VFR in the maxilla. Treatment outcome satisfaction, quality of care and attention, side-effects during the retention phase, and retainer acceptance and compliance were assessed with questionnaires at baseline (T1, 2 weeks after debond) and after 6 (T2) and 18 months (T3) of retention. Operator was blinded to group assignment during measurements. RESULTS Ninety-five patients completed the questionnaires at all three time points. Patients were overall satisfied with treatment outcome, quality of care and attention, and how their retainers worked at all three time points, with no differences between groups. At T1 and T3, the VFR group reported significantly more pain and discomfort (T1: P = 0.005, T3: P < 0.0001) and soreness (T1: P = 0.001, T3: P = 0.011) in the mandible compared to the CTC group. The CTC group found it easier to get used to their retainers. After 18 months, 70.5 per cent in the VFR group and 73.9 per cent in the CTC group reported the recommended wear-time of the VFRs. Decreased wear-time was correlated to perceived pain and discomfort (rs = -0.421, P < 0.0001). LIMITATIONS The results were limited by our retainer design and recommended wear regimen. CONCLUSIONS Both groups reported high treatment outcome satisfaction and low levels of side-effects during the retention phase. Nevertheless, the VFR group reported more pain and discomfort at T1 and at T3. Self-reported compliance was the same in both groups. The VFR group was more concerned about relapse. TRIAL REGISTRATION NCT03070444 (https://clinicaltrials.gov).",2020,Decreased wear-time was correlated to perceived pain and discomfort,['104 adolescent patients'],"['vacuum-formed retainer (VFR', 'removable vacuum-formed Essix C retainers with bonded cuspid-to-cuspid retainers (CTCs', 'CTC', 'Vacuum-formed retainers and bonded retainers', 'VFR']","['wear-time of the VFRs', 'quality of care and attention', 'Treatment outcome satisfaction, quality of care and attention, side-effects during the retention phase, and retainer acceptance and compliance', 'pain and discomfort', 'soreness']","[{'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0042221', 'cui_str': 'Vacuum'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0242919', 'cui_str': 'Orthodontic retainer'}, {'cui': 'C0028758', 'cui_str': 'Bonding (Psychology)'}, {'cui': 'C0010482', 'cui_str': 'Structure of canine tooth'}, {'cui': 'C0027625', 'cui_str': 'Circulating Neoplastic Cells'}, {'cui': 'C0441421', 'cui_str': 'Fixed orthodontic appliance'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0034379', 'cui_str': 'Quality of Care'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0242919', 'cui_str': 'Orthodontic retainer'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0234233', 'cui_str': 'Soreness'}]",104.0,0.175301,Decreased wear-time was correlated to perceived pain and discomfort,"[{'ForeName': 'Anke', 'Initials': 'A', 'LastName': 'Krämer', 'Affiliation': 'Orthodontic Clinic, Public Dental Health, Region Gävleborg, Gävle, Sweden.'}, {'ForeName': 'Mats', 'Initials': 'M', 'LastName': 'Sjöström', 'Affiliation': 'Department of Odontology/Oral and Maxillofacial Surgery, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Mats', 'Initials': 'M', 'LastName': 'Hallman', 'Affiliation': 'Centre for Research and Development, Uppsala University/Region Gävleborg, Gävle, Sweden.'}, {'ForeName': 'Ingalill', 'Initials': 'I', 'LastName': 'Feldmann', 'Affiliation': 'Centre for Research and Development, Uppsala University/Region Gävleborg, Gävle, Sweden.'}]",European journal of orthodontics,['10.1093/ejo/cjaa039'] 2600,32613281,Adverse event management in the TOURMALINE-MM3 study of post-transplant ixazomib maintenance in multiple myeloma.,"The phase 3, double-blind, placebo-controlled TOURMALINE-MM3 study (NCT02181413) demonstrated improved progression-free survival with ixazomib maintenance versus placebo post autologous stem cell transplant (ASCT) in multiple myeloma patients. We report additional safety data from TOURMALINE-MM3 to inform adverse event (AE) management recommendations. Patients were randomized 3:2 to receive ixazomib (n = 395) or placebo (n = 261) on days 1, 8, and 15 of 28-day cycles for ~ 2 years or until progressive disease/toxicity. The initial 3-mg ixazomib dose was escalated to 4 mg in cycle 5, if tolerated in cycles 1-4. Safety was a secondary endpoint assessed in all treated patients; AEs were graded using Common Terminology Criteria for AEs v4.03. The rate of grade ≥ 3 AEs was higher in the ixazomib arm (19%) than in the placebo arm (5%), but the rate of discontinuation due to AEs was similar (7% vs. 5%). For AEs of clinical interest, rates were higher with ixazomib versus placebo: nausea 39% versus 15%, vomiting 27% versus 11%, diarrhea 35% versus 24%, thrombocytopenia 13% versus 3%, and peripheral neuropathy 19% versus 15%. However, the majority of events were low-grade, manageable with supportive therapy or dose reduction, and reversible, and did not result in discontinuation. There was no evidence of cumulative, long-term, or late-onset toxicity with ixazomib maintenance. Ixazomib is an efficacious and tolerable option for post-ASCT maintenance. AEs associated with ixazomib maintenance can be managed in the context of routine post-ASCT supportive care due to the limited additional toxicity. ClinicalTrials.gov NCT02181413.",2020,"For AEs of clinical interest, rates were higher with ixazomib versus placebo: nausea 39% versus 15%, vomiting 27% versus 11%, diarrhea 35% versus 24%, thrombocytopenia 13% versus 3%, and peripheral neuropathy 19% versus 15%.",['multiple myeloma patients'],"['ixazomib maintenance versus placebo post autologous stem cell transplant (ASCT', 'Ixazomib', 'ixazomib', 'placebo']","['diarrhea', 'rate of grade ≥\u20093 AEs', 'progression-free survival', 'thrombocytopenia', 'rate of discontinuation due to AEs', 'vomiting', 'cumulative, long-term, or late-onset toxicity']","[{'cui': 'C0026764', 'cui_str': 'Multiple myeloma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C3273711', 'cui_str': 'ixazomib'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0472699', 'cui_str': 'Hemopoietic stem cell transplant'}]","[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0639010', 'cui_str': '3-(2-aminoethyl)-8-(3-(4-fluorobenzoyl)propyl)-4-oxo-1-phenyl-1,3,8-triazaspiro(4.5)decan-4-one'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0040034', 'cui_str': 'Thrombocytopenic disorder'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0040539', 'cui_str': 'TO'}]",,0.566705,"For AEs of clinical interest, rates were higher with ixazomib versus placebo: nausea 39% versus 15%, vomiting 27% versus 11%, diarrhea 35% versus 24%, thrombocytopenia 13% versus 3%, and peripheral neuropathy 19% versus 15%.","[{'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Kaiser', 'Affiliation': 'Department of Haematology, The Royal Marsden Hospital, London, UK. Martin.Kaiser@icr.ac.uk.'}, {'ForeName': 'Meral', 'Initials': 'M', 'LastName': 'Beksaç', 'Affiliation': 'Department of Hematology, Ankara University, Ankara, Turkey.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Gulbrandsen', 'Affiliation': 'Oslo Myeloma Center, Oslo University Hospital, and KG Jebsen Center for B Cell Malignancies, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Fredrik', 'Initials': 'F', 'LastName': 'Schjesvold', 'Affiliation': 'Oslo Myeloma Center, Oslo University Hospital, and KG Jebsen Center for B Cell Malignancies, University of Oslo, Oslo, Norway.'}, {'ForeName': 'Roman', 'Initials': 'R', 'LastName': 'Hájek', 'Affiliation': 'Department of Hematooncology, University Hospital Ostrava, Ostrava, Czech Republic.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Moreau', 'Affiliation': 'Department of Hematology, University Hospital Hôtel-Dieu, Nantes, France.'}, {'ForeName': 'Felipe', 'Initials': 'F', 'LastName': 'de Arriba de la Fuente', 'Affiliation': 'Servicio de Hematología y Oncología Médica, Hospital Universitario Morales Meseguer y Centro Regional de Hemodonación, IMIB-Arrixaca, Universidad de Murcia, Murcia, Spain.'}, {'ForeName': 'María-Victoria', 'Initials': 'MV', 'LastName': 'Mateos', 'Affiliation': 'Department of Hematology, University Hospital of Salamanca, CIC, IBM CC, Salamanca, Spain.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'West', 'Affiliation': 'Department of Haematology, The Royal Marsden Hospital, London, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Spencer', 'Affiliation': 'Malignant Haematology and Stem Cell Transplantation Service, Alfred Health-Monash University, Melbourne, Australia.'}, {'ForeName': 'S Vincent', 'Initials': 'SV', 'LastName': 'Rajkumar', 'Affiliation': 'Division of Hematology, Department of Internal Medicine, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Kaveri', 'Initials': 'K', 'LastName': 'Suryanarayan', 'Affiliation': 'Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, MA, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Czorniak', 'Affiliation': 'Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, MA, USA.'}, {'ForeName': 'Cong', 'Initials': 'C', 'LastName': 'Li', 'Affiliation': 'Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, MA, USA.'}, {'ForeName': 'Zhaoyang', 'Initials': 'Z', 'LastName': 'Teng', 'Affiliation': 'Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, MA, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Labotka', 'Affiliation': 'Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited, Cambridge, MA, USA.'}, {'ForeName': 'Meletios A', 'Initials': 'MA', 'LastName': 'Dimopoulos', 'Affiliation': 'Hematology and Medical Oncology, Department of Clinical Therapeutics, School of Medicine, National and Kapodistrian University of Athens, Athens, Greece.'}]",Annals of hematology,['10.1007/s00277-020-04149-5'] 2601,32613329,Baseline iron and low-grade inflammation modulate the effectiveness of iron supplementation: evidence from follow-up of pregnant Sri Lankan women.,"PURPOSE We evaluated the effectiveness of iron supplementation in relation to baseline iron and inflammatory status of pregnant women and their offspring in Sri Lanka. METHODS Apparently healthy women aged 18-36 years at < 12 weeks of gestation prior to receiving any supplementation were randomly recruited at the antenatal clinics. They received 60 mg of elemental iron in combined iron-folic acid pills from 12 weeks of gestation until delivery via the National Maternal Supplementation Programme. Serum ferritins (SF), hemoglobin and high-sensitive C-reactive protein (hs-CRP) were assessed. The women were grouped as iron sufficient-inflammation (+), iron sufficient-inflammation (-), iron deficient-inflammation (+) and iron deficient-inflammation (-) based on their baseline iron stores and low-grade inflammation (hs-CRP > 5 < 10 mg/L) at baseline and late pregnancy. RESULTS Despite supplementation, SF in the iron sufficient-inflammation (+) women reduced significantly (p = 0.037) to deficiency state (SF < 30 µg/L) at mid-pregnancy. Whereas no significant changes were noted in the SF in iron sufficient-inflammation (-) women (p > 0.05). They maintained their stores at sufficient state until delivery. The cord SF was higher (p < 0.001) in iron sufficient-inflammation (-) than the inflammation (+) women. 96.4% of the iron deficient women remained deficient until delivery regardless of their inflammatory state. Low-grade inflammation was higher (p < 0.001) in women with baseline BMI > 25 kg/m 2 . Whereas inflammation at late pregnancy was higher (p < 0.001) in women who gained weight in excess of the recommended, regardless of their baseline BMI. CONCLUSION Iron status prior to supplementation and low-grade inflammation associated with BMI > 25 kg/m 2 and excess weight gain during pregnancy appear to modulate the effectiveness of iron supplementation.",2020,"Despite supplementation, SF in the iron sufficient-inflammation (+) women reduced significantly (p = 0.037) to deficiency state (SF < 30 µg/L) at mid-pregnancy.","['pregnant Sri Lankan women', 'pregnant women and their offspring in Sri Lanka', 'Apparently healthy women aged 18-36\xa0years at\u2009<\u200912\xa0weeks of gestation prior to receiving any supplementation were randomly recruited at the antenatal clinics']","['60\xa0mg of elemental iron in combined iron-folic acid pills', 'iron supplementation']","['SF in iron sufficient-inflammation', 'Serum ferritins (SF), hemoglobin and high-sensitive C-reactive protein (hs-CRP', 'cord SF', 'weight gain', 'Low-grade inflammation', 'inflammation at late pregnancy', 'iron sufficient-inflammation (+), iron sufficient-inflammation (-), iron deficient-inflammation (+) and iron deficient-inflammation (-) based on their baseline iron stores and low-grade inflammation (hs-CRP ']","[{'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0038088', 'cui_str': 'Sri Lanka'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C1274027', 'cui_str': 'Antenatal clinic'}]","[{'cui': 'C0302583', 'cui_str': 'Iron'}, {'cui': 'C0357067', 'cui_str': 'Folic acid- and iron-containing product'}, {'cui': 'C0009905', 'cui_str': 'Oral Contraceptives'}, {'cui': 'C3537005', 'cui_str': 'Iron supplement therapy'}]","[{'cui': 'C0696113', 'cui_str': 'Serum ferritin measurement'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C3489532', 'cui_str': 'Cone-Rod Dystrophy 2'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C1962916', 'cui_str': 'Low grade (lymphoma)'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0011155', 'cui_str': 'Deficiency'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0450235', 'cui_str': 'Evaluation of iron stores'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}]",,0.16506,"Despite supplementation, SF in the iron sufficient-inflammation (+) women reduced significantly (p = 0.037) to deficiency state (SF < 30 µg/L) at mid-pregnancy.","[{'ForeName': 'Miruna Sudharshani Kalaimani', 'Initials': 'MSK', 'LastName': 'Rabindrakumar', 'Affiliation': 'Department of Biochemistry and Molecular Biology, Faculty of Medicine, University of Colombo, P.O. Box-271, Colombo 8, Sri Lanka.'}, {'ForeName': 'V Pujitha', 'Initials': 'VP', 'LastName': 'Wickramasinghe', 'Affiliation': 'Department of Paediatrics, Faculty of Medicine, University of Colombo, Colombo, Sri Lanka.'}, {'ForeName': 'Carukshi', 'Initials': 'C', 'LastName': 'Arambepola', 'Affiliation': 'Department of Community Medicine, Faculty of Medicine, University of Colombo, Colombo, Sri Lanka.'}, {'ForeName': 'Hemantha', 'Initials': 'H', 'LastName': 'Senanayake', 'Affiliation': 'Department of Obstetrics and Gynecology, Faculty of Medicine, University of Colombo, Colombo, Sri Lanka.'}, {'ForeName': 'Veranja', 'Initials': 'V', 'LastName': 'Karunaratne', 'Affiliation': 'Department of Chemistry, University of Peradeniya, Peradeniya, Sri Lanka.'}, {'ForeName': 'Tharanga', 'Initials': 'T', 'LastName': 'Thoradeniya', 'Affiliation': 'Department of Biochemistry and Molecular Biology, Faculty of Medicine, University of Colombo, P.O. Box-271, Colombo 8, Sri Lanka. tharanga@bmb.cmb.ac.lk.'}]",European journal of nutrition,['10.1007/s00394-020-02320-2'] 2602,32613332,Matching Psychosocial Support Needs of Parents of a Child with a Chronic Illness to a Feasible Intervention.,"OBJECTIVES Parents of children with a chronic illness (CI) are at risk for psychosocial problems. The aim of this study was to refine an existing face-to-face intervention into an online psychosocial group intervention for parents by (1) exploring which themes are important, (2) determine what type of intervention parents would like and (3) assess parents' practical preferences. METHODS Parents of children with a CI (0-18 years) were invited to complete an online questionnaire. To acquire more in-depth information, focus groups and telephone interviews were conducted. Descriptive statistics were used. RESULTS 272 parents (mean age = 43.1 years, 85% female) participated. Three focus groups (15 parents) and seven telephone interviews were conducted. Most important themes were: the CI of the child, family functioning, taking care of yourself, relationships with others and practical support. Parents preferred a group with parents of children in the same age category. At first, parents preferred face-to-face contact. After an explanation and demonstration of an online intervention, parents became more positive about online support, mostly because they could participate from home. CONCLUSIONS FOR PRACTICE Parents have a need for psychosocial support focusing on different themes. Professionals should explain and demonstrate an online intervention to parents. Based on these results, Op Koers Online for parents was developed. An RCT to assess feasibility and effectiveness of the intervention is currently running.",2020,"After an explanation and demonstration of an online intervention, parents became more positive about online support, mostly because they could participate from home. ","['Parents of children with a chronic illness (CI', 'Parents of children with a CI (0-18\xa0years', '272 parents (mean age\u2009=\u200943.1\xa0years, 85% female) participated']",[],[],"[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0008679', 'cui_str': 'Chronic disease'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]",[],[],272.0,0.0280083,"After an explanation and demonstration of an online intervention, parents became more positive about online support, mostly because they could participate from home. ","[{'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Douma', 'Affiliation': ""Psychosocial Department (G8-136), Emma Children's Hospital, Amsterdam University Medical Centers, Meibergdreef 9, 1105 AZ, Amsterdam, the Netherlands. m.douma@amsterdamumc.nl.""}, {'ForeName': 'Charlotte P', 'Initials': 'CP', 'LastName': 'Bouman', 'Affiliation': ""Psychosocial Department (G8-136), Emma Children's Hospital, Amsterdam University Medical Centers, Meibergdreef 9, 1105 AZ, Amsterdam, the Netherlands.""}, {'ForeName': 'Hedy A', 'Initials': 'HA', 'LastName': 'van Oers', 'Affiliation': ""Psychosocial Department (G8-136), Emma Children's Hospital, Amsterdam University Medical Centers, Meibergdreef 9, 1105 AZ, Amsterdam, the Netherlands.""}, {'ForeName': 'Heleen', 'Initials': 'H', 'LastName': 'Maurice-Stam', 'Affiliation': ""Psychosocial Department (G8-136), Emma Children's Hospital, Amsterdam University Medical Centers, Meibergdreef 9, 1105 AZ, Amsterdam, the Netherlands.""}, {'ForeName': 'Lotte', 'Initials': 'L', 'LastName': 'Haverman', 'Affiliation': ""Psychosocial Department (G8-136), Emma Children's Hospital, Amsterdam University Medical Centers, Meibergdreef 9, 1105 AZ, Amsterdam, the Netherlands.""}, {'ForeName': 'Martha A', 'Initials': 'MA', 'LastName': 'Grootenhuis', 'Affiliation': ""Psychosocial Department (G8-136), Emma Children's Hospital, Amsterdam University Medical Centers, Meibergdreef 9, 1105 AZ, Amsterdam, the Netherlands.""}, {'ForeName': 'Linde', 'Initials': 'L', 'LastName': 'Scholten', 'Affiliation': ""Psychosocial Department (G8-136), Emma Children's Hospital, Amsterdam University Medical Centers, Meibergdreef 9, 1105 AZ, Amsterdam, the Netherlands.""}]",Maternal and child health journal,['10.1007/s10995-020-02925-3'] 2603,32613374,Supportive health education reduces health care utilization and costs in Latinas with breast cancer and their caregivers.,"PURPOSE To compare costs and relative cost savings from reductions in unscheduled health services use for two 8-week psychosocial interventions (telephone interpersonal counseling [TIPC], supportive health education [SHE]) delivered by telephone to Latinas with breast cancer and their informal caregivers. Cost information is required before adopting supportive care interventions as part of routine care. There is limited information on costs of producing supportive care interventions or their impact on service use. METHODS Latinas and their caregivers were randomized to either TIPC or SHE. At baseline and month 4, hospitalizations and urgent care and emergency department (ED) visits in the previous month were recorded. These were compared by trial arm for 181 survivors and 169 caregivers using logistic regression, adjusting for age and health services use at baseline. RESULTS Total cost per 100 survivors was $28,695 for SHE and $27,399 for TIPC. Urgent care and ED visits were reduced for survivors in SHE versus TIPC (odds ratio (OR) = 0.31, 95% confidence interval (CI) [0.12, 0.88], p = .03). For hospitalizations, OR for SHE versus TIPC was 0.59, 95% CI [0.26, 1.37], p = .07. There were no differences between trial arms for caregiver health services use. Cost savings for SHE versus TIPC from reductions in health services use per 100 survivors ranged from $800 for urgent care to $17,000 for ED visits and $13,000 for hospitalizations. CONCLUSIONS Based on this evidence, SHE can be a cost-saving supportive care solution that benefits not only survivors and caregivers, but also oncology practices reimbursed through episodes of care.",2020,"Urgent care and ED visits were reduced for survivors in SHE versus TIPC (odds ratio (OR) = 0.31, 95% confidence interval (CI) [","['Latinas and their caregivers', '181 survivors and 169 caregivers using logistic regression, adjusting for age and health services use at baseline', 'Latinas with breast cancer and their caregivers', 'Latinas with breast cancer and their informal caregivers']","['psychosocial interventions (telephone interpersonal counseling [TIPC], supportive health education [SHE', 'Supportive health education', 'TIPC or SHE', 'SHE versus TIPC']","['Cost savings', 'hospitalizations and urgent care and emergency department (ED) visits']","[{'cui': 'C0949335', 'cui_str': 'Latinas'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0206031', 'cui_str': 'Logistic Regression'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0018747', 'cui_str': 'Services, Health'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C1319882', 'cui_str': 'Informal caregiver'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C0085550', 'cui_str': 'Cost Savings'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C2362545', 'cui_str': 'Urgent Care'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}]",,0.0690219,"Urgent care and ED visits were reduced for survivors in SHE versus TIPC (odds ratio (OR) = 0.31, 95% confidence interval (CI) [","[{'ForeName': 'Terry A', 'Initials': 'TA', 'LastName': 'Badger', 'Affiliation': 'College of Nursing, University of Arizona, Tucson, AZ, 85721, USA. tbadger@email.arizona.edu.'}, {'ForeName': 'Alla', 'Initials': 'A', 'LastName': 'Sikorskii', 'Affiliation': 'Department of Psychiatry, Michigan State University, East Lansing, MI, 48824, USA.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Segrin', 'Affiliation': 'Department of Communication, University of Arizona, Tucson, AZ, 85721, USA.'}, {'ForeName': 'Charles W', 'Initials': 'CW', 'LastName': 'Given', 'Affiliation': 'College of Nursing, Michigan State University, East Lansing, MI, 48824, USA.'}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-020-05593-9'] 2604,32613565,"Assessing the impact of a combination of sofosbuvir and daclatasvir treatment for hepatitis C virus infection on heart rate, rhythm and heart rate variability using 24-hour ECG monitoring.","BACKGROUND Direct-acting antiviral agents (DAAs) cure patients with hepatitis C virus (HCV) infection. Concerns have arisen the occurrence of significant bradyarrhythmias during treatment with DAAs. The aim of this study was to assess the impact of a DAA combination for the treatment of HCV infection on heart rate, rhythm, and heart rate variability (HRV) using 24-h ECG monitoring. RESULTS A prospective randomized study of 50 treatment-naïve patients with HCV infection treated with a combination of sofosbuvir 400 mg daily and daclatasvir 60 mg daily for 12 weeks. Surface ECG and 24-h ECG monitoring were performed at baseline and after completion of therapy to assess PR interval, corrected QT interval (QTc), minimum heart rate (HR), maximum HR, average HR, HRV time-domain and frequency-domain measures, significant pauses, tachycardias, bradycardias, premature atrial contractions (PACs), and premature ventricular contraction (PVCs). No differences were detected in all examined parameters between baseline and after completion of treatment. PR interval was 154 ± 25.95 vs 151.4 ± 23.82 ms, respectively (p = 0.124). QTc interval was 397.34 ± 29.38 vs 395.04 ± 30.23 ms, respectively (p = 0.403). No differences were detected for minimum HR, maximum HR, average HR, HRV time-domain and frequency-domain measures, the occurrence of significant pauses, sinus tachycardia episodes, sinus bradycardia episodes, PACs, and PVCs. No episodes of bradyarrhythmias, syncope, and atrial fibrillation, supraventricular, or ventricular tachycardias were reported or detected. CONCLUSION In non-cardiac patients receiving no cardioactive medications, the combination of sofosbuvir and daclatasvir for the treatment of HCV infection has no effect on HR, rhythm, conductivity, or HRV. No symptomatic bradycardias, tachycardias, or syncope were reported or detected using 24-h ECG monitoring.",2020,"No differences were detected for minimum HR, maximum HR, average HR, HRV time-domain and frequency-domain measures, the occurrence of significant pauses, sinus tachycardia episodes, sinus bradycardia episodes, PACs, and PVCs.","['50 treatment-naïve patients with HCV infection treated with a', 'cure patients with hepatitis C virus (HCV) infection']","['DAA combination', 'sofosbuvir and daclatasvir treatment', 'Direct-acting antiviral agents (DAAs', 'combination of sofosbuvir 400 mg daily and daclatasvir']","['HR, rhythm, conductivity, or HRV', 'minimum HR, maximum HR, average HR, HRV time-domain and frequency-domain measures, the occurrence of significant pauses, sinus tachycardia episodes, sinus bradycardia episodes, PACs, and PVCs', 'symptomatic bradycardias, tachycardias, or syncope', 'heart rate, rhythm, and heart rate variability (HRV', 'episodes of bradyarrhythmias, syncope, and atrial fibrillation, supraventricular, or ventricular tachycardias', 'Surface ECG and 24-h ECG monitoring', 'PR interval, corrected QT interval (QTc), minimum heart rate (HR), maximum HR, average HR, HRV time-domain and frequency-domain measures, significant pauses, tachycardias, bradycardias, premature atrial contractions (PACs), and premature ventricular contraction (PVCs', 'heart rate, rhythm and heart rate variability']","[{'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019196', 'cui_str': 'Viral hepatitis C'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0079500', 'cui_str': 'Hepacivirus'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}]","[{'cui': 'C2976303', 'cui_str': 'sofosbuvir'}, {'cui': 'C3252090', 'cui_str': 'daclatasvir'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0003451', 'cui_str': 'Antiviral'}, {'cui': 'C3696663', 'cui_str': 'sofosbuvir 400 MG'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0013777', 'cui_str': 'Electrical Conductivity'}, {'cui': 'C0744679', 'cui_str': 'Maximum heart rate'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0039239', 'cui_str': 'Sinus tachycardia'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0085610', 'cui_str': 'Sinus bradycardia'}, {'cui': 'C0033036', 'cui_str': 'Atrial premature complex'}, {'cui': 'C0151636', 'cui_str': 'Ventricular premature beats'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0428977', 'cui_str': 'Bradycardia'}, {'cui': 'C0039231', 'cui_str': 'Tachycardia'}, {'cui': 'C0039070', 'cui_str': 'Syncope'}, {'cui': 'C0079035', 'cui_str': 'Bradyarrhythmia'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0042514', 'cui_str': 'Ventricular tachycardia'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0180580', 'cui_str': 'Electrocardiographic monitoring'}, {'cui': 'C0429087', 'cui_str': 'PR interval - finding'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0429028', 'cui_str': 'QT interval feature'}]",,0.0253685,"No differences were detected for minimum HR, maximum HR, average HR, HRV time-domain and frequency-domain measures, the occurrence of significant pauses, sinus tachycardia episodes, sinus bradycardia episodes, PACs, and PVCs.","[{'ForeName': 'Ahmed Mohamed', 'Initials': 'AM', 'LastName': 'El Missiri', 'Affiliation': 'Cardiology Department, Faculty of Medicine, Ain Shams University, Abbassia square, Abbasia, Cairo, 11566, Egypt. amissiri@med.asu.edu.eg.'}, {'ForeName': 'Mona Mostafa', 'Initials': 'MM', 'LastName': 'Rayan', 'Affiliation': 'Cardiology Department, Faculty of Medicine, Ain Shams University, Abbassia square, Abbasia, Cairo, 11566, Egypt.'}, {'ForeName': 'Mohamed Medhat', 'Initials': 'MM', 'LastName': 'Awad', 'Affiliation': 'Cardiology Department, Faculty of Medicine, Ain Shams University, Abbassia square, Abbasia, Cairo, 11566, Egypt.'}, {'ForeName': 'Ahmed Ibrahim', 'Initials': 'AI', 'LastName': 'El Desoky', 'Affiliation': 'Cardiology Department, Faculty of Medicine, Ain Shams University, Abbassia square, Abbasia, Cairo, 11566, Egypt.'}]",The Egyptian heart journal : (EHJ) : official bulletin of the Egyptian Society of Cardiology,['10.1186/s43044-020-00070-4'] 2605,32613634,Evidence for improved systemic and local vascular function after long-term passive static stretching training of the musculoskeletal system.,"KEY POINTS Vascular function and arterial stiffness are important markers of cardiovascular health and cardiovascular co-morbidity. Transitional phases of hypoemia and hypermia, with consequent fluctuations in shear rate, occuring during repetitive passive stretching adminstration (passive stretching training) may constitute an effective stimulus to induce an amelioration in vascular function, arterial stiffness and vascular remodelling by improving central and local blood flow control mechanisms. Vascular function, arterial stiffness and vascular remodelling were evaluated before and after 12 weeks of passive stretching training and after 6 weeks from training cessation, in the femoral, popliteal (treated with stretching), and brachial arteries (untreated) of both sides. After passive stretching training, vascular function and arterial remodelling improved, and arterial stiffness decreased in all the arteries, suggesting modifications of both central and local blood flow control mechanisms. Passive stretching-induced improvements related to central mechanisms seemed to have a short duration, as they returned to pre-training baseline within 6 weeks from training cessation, whereas those more related to a local mechanism persisted in the follow-up. ABSTRACT Acute passive stretching (PS) effects on blood flow ( Q ̇ ), shear rate ( Y ̇ ), and vascular function in the feeding arteries of the stretched muscle have been extensively investigated; however, few data are available on vascular adjustments induced by long-term PS training. We investigated the effects of PS training on vascular function and stiffness of the involved (femoral and popliteal) and uninvolved (brachial) arteries. Our hypothesis was that PS-induced changes in Q ̇ and Y ̇ would improve central and local mechanisms of Q ̇ control. Thirty-nine participants were randomly assigned to bilateral PS (n = 14), monolateral PS (n = 13) or no PS training (n = 12). Vascular function was measured before and after 12 weeks of knee extensor and plantar flexor muscles' PS training by single passive limb movement and flow-mediated dilatation (FMD). Central (carotid-femoral artery PWV, PWV CF ) and peripheral (carotid-radial artery PWV, PWV CR ) arterial stiffness was measured by pulse-wave velocity (PWV), together with systolic (SBP) and diastolic (DBP) blood pressure. After PS training, increases of 30%, 25% and 8% (P < 0.05) in femoral Δ Q ̇ , popliteal and brachial artery FMD%, respectively, occurred in both PS training groups. A decrease in PWV CF , PWV CR , SBP and DBP (-25%, -17%, -4% and -8%, respectively; P < 0.05) was noted. No changes occurred in controls. Vascular function improved and arterial stiffness reduced in the arteries involved and uninvolved with PS training, suggesting modifications in both central and local Q ̇ control mechanisms. PS-induced improvements had a short duration in some of vascular function parameters, as they returned to baseline within 6 weeks of PS training cessation.",2020,"After PS training, increases of 30%, 25% and 8% (P < 0.05) in femoral Δ Q ̇ , popliteal and brachial artery FMD%, respectively, occurred in both PS training groups.",['Thirty-nine participants'],"['bilateral PS', 'repetitive passive stretching adminstration (passive stretching training', 'passive stretching training', 'monolateral PS (n\xa0=\xa013) or no PS training', 'PS training']","['pulse-wave velocity (PWV), together with systolic (SBP) and diastolic (DBP) blood pressure', 'blood flow ( Q ̇ ), shear rate ( Y ̇ ), and vascular function', 'vascular function and arterial remodelling improved, and arterial stiffness', 'Vascular function improved and arterial stiffness', 'systemic and local vascular function', 'vascular function and stiffness of the involved (femoral and popliteal) and uninvolved (brachial) arteries', 'Vascular function', 'Central (carotid-femoral artery PWV, PWV CF ) and peripheral (carotid-radial artery PWV, PWV CR ) arterial stiffness', 'cardiovascular health and cardiovascular co-morbidity', 'Vascular function, arterial stiffness and vascular remodelling', 'PWV CF , PWV CR , SBP and DBP ', 'vascular function parameters']","[{'cui': 'C3816447', 'cui_str': '39'}]","[{'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C1720871', 'cui_str': 'Static-Passive Stretching'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C3494431', 'cui_str': 'Pulse Wave Velocity'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0175735', 'cui_str': 'Scissors'}, {'cui': 'C0232337', 'cui_str': 'Vascular function'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0599949', 'cui_str': 'Arterial stiffness'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}, {'cui': 'C0015811', 'cui_str': 'Bone structure of femur'}, {'cui': 'C0442037', 'cui_str': 'Popliteal'}, {'cui': 'C0205429', 'cui_str': 'Uninvolved'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0015801', 'cui_str': 'Structure of femoral artery'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0162857', 'cui_str': 'Structure of radial artery'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0085805', 'cui_str': 'Androgen Binding Protein'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",39.0,0.0690637,"After PS training, increases of 30%, 25% and 8% (P < 0.05) in femoral Δ Q ̇ , popliteal and brachial artery FMD%, respectively, occurred in both PS training groups.","[{'ForeName': 'A V', 'Initials': 'AV', 'LastName': 'Bisconti', 'Affiliation': 'Department of Biomedical Sciences for Health (SCIBIS), University of Milan, Milan, Italy.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Cè', 'Affiliation': 'Department of Biomedical Sciences for Health (SCIBIS), University of Milan, Milan, Italy.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Longo', 'Affiliation': 'Department of Biomedical Sciences for Health (SCIBIS), University of Milan, Milan, Italy.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Venturelli', 'Affiliation': 'Department of Internal Medicine, The University of Utah, Salt Lake City, UT, USA.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Coratella', 'Affiliation': 'Department of Biomedical Sciences for Health (SCIBIS), University of Milan, Milan, Italy.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Limonta', 'Affiliation': 'Department of Biomedical Sciences for Health (SCIBIS), University of Milan, Milan, Italy.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Doria', 'Affiliation': 'Department of Biomedical Sciences for Health (SCIBIS), University of Milan, Milan, Italy.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Rampichini', 'Affiliation': 'Department of Biomedical Sciences for Health (SCIBIS), University of Milan, Milan, Italy.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Esposito', 'Affiliation': 'Department of Biomedical Sciences for Health (SCIBIS), University of Milan, Milan, Italy.'}]",The Journal of physiology,['10.1113/JP279866'] 2606,32613644,A preliminary comparison of the efficacy of online Acceptance and Commitment Therapy (ACT) and Cognitive Behavioural Therapy (CBT) stress management interventions for social and healthcare workers.,"Social and healthcare workers have been shown to experience greater levels of illness, depression and burnout as a result of chronic workplace stress. The purpose of this study was to examine whether brief online ACT and CBT interventions could reduce the experience of stress and burnout in employees, while also improving mental health and psychological flexibility. A total of 42 individuals working within the social and healthcare professions were randomly assigned to either a 2-week online ACT or CBT intervention. Recruitment was undertaken internationally, although the majority of participants were based in Ireland at the time of their participation (79%). Participants' perceived stress, burnout, mental health and work-related psychological flexibility were assessed at baseline and post-treatment. Intent-to-treat analyses were conducted on all data. Outcomes indicated that both interventions resulted in significant improvements in stress, burnout and mental health scores from baseline to post-treatment. No significant differences were observed between ACT and CBT conditions, or in psychological flexibility scores from baseline to post-treatment. Reliable Change Index (RCI) scores indicated that clinically significant reductions in stress and mental health were seen in 42% and 19% of programme-completers, respectively. These results provide preliminary evidence for the usefulness of brief internet-delivered ACT and CBT interventions for the treatment of occupational stress and its comorbid symptoms. Online programmes with a longer duration and additional therapist support should be evaluated, as these may improve the outcomes of future interventions.",2020,"Outcomes indicated that both interventions resulted in significant improvements in stress, burnout and mental health scores from baseline to post-treatment.","['42 individuals working within the social and healthcare professions', 'social and healthcare workers']","['ACT and CBT interventions', 'online ACT or CBT intervention', 'online Acceptance and Commitment Therapy (ACT) and Cognitive Behavioural Therapy (CBT) stress management interventions', 'online ACT and CBT interventions']","['stress, burnout, mental health and work-related psychological flexibility', 'psychological flexibility scores', 'stress and mental health', 'Reliable Change Index (RCI) scores', 'stress, burnout and mental health scores', 'mental health and psychological flexibility']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0086388', 'cui_str': 'Healthcare'}, {'cui': 'C0028811', 'cui_str': 'Occupation'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}]","[{'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C3658321', 'cui_str': 'Acceptance and commitment therapy'}, {'cui': 'C0150788', 'cui_str': 'Stress management'}]","[{'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0476644', 'cui_str': 'Physical AND emotional exhaustion state'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",42.0,0.061123,"Outcomes indicated that both interventions resulted in significant improvements in stress, burnout and mental health scores from baseline to post-treatment.","[{'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Barrett', 'Affiliation': 'School of Psychology, National University of Ireland, Galway, Ireland.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Stewart', 'Affiliation': 'School of Psychology, National University of Ireland, Galway, Ireland.'}]",Health & social care in the community,['10.1111/hsc.13074'] 2607,32613664,"A comparison of Er,Cr:YSGG laser to minimally invasive surgical technique in the treatment of intrabony defects: six-month results of a multicenter, randomized, controlled study.","BACKGROUND The purpose of this publication is to report on the six-month clinical results and patient reported outcomes (PROs) comparing the surgical use of the Er,Cr:YSGG laser (ERL) and minimally invasive surgical technique (MIST) for the treatment of intrabony defects in subjects with generalized periodontitis stage III, grade B. METHODS Fifty-three adult subjects (29 females and 24 males; 19 to 73 years) with 79 intrabony defects were randomized following scaling and root planing (SRP) to receive ERL monotherapy (n = 27) or MIST (n = 26). Recession (REC), probing depth (PD), clinical attachment level (CAL), treatment time, and PROs were assessed and compared for each treatment group. Clinical measurements were recorded at baseline, 4-6 weeks following SRP, and six months following surgical therapy. RESULTS The following primary and secondary outcome variables were non-inferior with the following margins: CAL with a non-inferiority margin of 0.6 millimeters (mm). (p = 0.05), PD with a non-inferiority margin of 0.5 mm. (p = 0.05), Recession with a non-inferiority margin of 0.4 mm (p = 0.05). Faster procedure times were found for ERL (16.39 ± 6.21 minutes) vs MIST (20.17 ± 5.62 minutes), p = 0.0002. In the first two to three days of post therapeutic diary outcomes, subjects reported less bruising, facial swelling, and use of Ice pack for the ERL group. CONCLUSIONS This is the first multicenter, randomized, blinded, and controlled study demonstrating the Er,Cr:YSGG laser is not inferior to MIST in terms of clinical outcomes but is superior in PROs for the surgical treatment of intrabony defects. This article is protected by copyright. All rights reserved.",2020,",Cr:YSGG laser is not inferior to MIST in terms of clinical outcomes but is superior in PROs for the surgical treatment of intrabony defects.","['subjects with generalized periodontitis stage III, grade B.\nMETHODS\n\n\nFifty-three adult subjects (29 females and 24 males; 19 to 73 years) with 79 intrabony defects']","['MIST', 'scaling and root planing (SRP) to receive ERL monotherapy', 'YSGG laser to minimally invasive surgical technique', 'Er,Cr', 'Er,Cr:YSGG laser (ERL) and minimally invasive surgical technique (MIST']","['bruising, facial swelling, and use of Ice pack', 'non-inferior with the following margins', 'Recession (REC), probing depth (PD), clinical attachment level (CAL), treatment time, and PROs']","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0031099', 'cui_str': 'Periodontitis'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0243067', 'cui_str': 'defects'}]","[{'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0085287', 'cui_str': 'Root planing of tooth'}, {'cui': 'C0879167', 'cui_str': 'Yttrium-Scandium-Gallium Garnet Lasers'}]","[{'cui': 'C0009938', 'cui_str': 'Contusion'}, {'cui': 'C0151602', 'cui_str': 'Facial swelling'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0181264', 'cui_str': 'Ice bag'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0205284', 'cui_str': 'Marginal'}, {'cui': 'C0333047', 'cui_str': 'Recession'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}]",53.0,0.0953649,",Cr:YSGG laser is not inferior to MIST in terms of clinical outcomes but is superior in PROs for the surgical treatment of intrabony defects.","[{'ForeName': 'Donald', 'Initials': 'D', 'LastName': 'Clem', 'Affiliation': 'Fullerton, CA, USA.'}, {'ForeName': 'Rick', 'Initials': 'R', 'LastName': 'Heard', 'Affiliation': 'Victoria, TX, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'McGuire', 'Affiliation': 'Houston, TX, USA.'}, {'ForeName': 'E Todd', 'Initials': 'ET', 'LastName': 'Scheyer', 'Affiliation': 'Houston, TX, USA.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Richardson', 'Affiliation': 'Department of Periodontics, Virginia Commonwealth School of Dentistry, Richmond, VA, USA.'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Toback', 'Affiliation': 'New London, CT, USA.'}, {'ForeName': 'Chad', 'Initials': 'C', 'LastName': 'Gwaltney', 'Affiliation': 'Westerly, RI, USA.'}, {'ForeName': 'John C', 'Initials': 'JC', 'LastName': 'Gunsolley', 'Affiliation': 'Department of Periodontics, Virginia Commonwealth School of Dentistry, Richmond, VA, USA.'}]",Journal of periodontology,['10.1002/JPER.20-0028'] 2608,32614046,"Online Social Cognition Training in Schizophrenia: A Double-Blind, Randomized, Controlled Multi-Site Clinical Trial.","Social cognition (SC), the mental operations underlying social functioning, are impaired in schizophrenia. Their direct link to functional outcome and illness status have made them an important therapeutic target. However, no effective treatment for these deficits is currently applied as a standard of care. To address this need, we have developed SocialVille-an online, plasticity-based training program that targets SC deficits in schizophrenia. Here we report the outcomes of a double-blind, controlled, randomized, multi-site clinical trial of SocialVille. Outpatients with schizophrenia were randomized to complete 40 sessions of either SocialVille (N = 55 completers) or active control (computer games; N = 53 completers) from home. The a priori co-primary outcome measures were a social cognitive composite and a functional capacity outcome (UCSD Performance-based Skills Assessment [UPSA-2]). Secondary outcomes included a virtual functional capacity measure (VRFCAT), social functioning, quality of life, and motivation. Linear mixed models revealed a group × time interaction favoring the treatment group for the social cognitive composite (b = 2.81; P < .001) but not for the UPSA-2 measure. Analysis of secondary outcome measures showed significant group × time effects favoring the treatment group on SC and social functioning, on the virtual functional capacity measure and a motivation subscale, although these latter findings were nonsignificant with FDR correction. These results provide support for the efficacy of a remote, plasticity-based social cognitive training program in improving SC and social functioning in schizophrenia. Such treatments may serve as a cost-effective adjunct to existing psychosocial treatments. Trial Registration: NCT02246426.",2020,"Analysis of secondary outcome measures showed significant group × time effects favoring the treatment group on SC and social functioning, on the virtual functional capacity measure and a motivation subscale, although these latter findings were nonsignificant with FDR correction.","['Outpatients with schizophrenia', 'Schizophrenia']",['Online Social Cognition Training'],"['social cognitive composite', 'SC and social functioning, on the virtual functional capacity measure and a motivation subscale', 'virtual functional capacity measure (VRFCAT), social functioning, quality of life, and motivation', 'Social cognition (SC', 'social cognitive composite and a functional capacity outcome (UCSD Performance-based Skills Assessment [UPSA-2']","[{'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}]","[{'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0037395', 'cui_str': 'Social adjustment'}, {'cui': 'C1998319', 'cui_str': 'Functional capacity'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",,0.0826226,"Analysis of secondary outcome measures showed significant group × time effects favoring the treatment group on SC and social functioning, on the virtual functional capacity measure and a motivation subscale, although these latter findings were nonsignificant with FDR correction.","[{'ForeName': 'Mor', 'Initials': 'M', 'LastName': 'Nahum', 'Affiliation': 'School of Occupational Therapy, Faculty of Medicine, Hebrew University, Jerusalem, Israel.'}, {'ForeName': 'Hyunkyu', 'Initials': 'H', 'LastName': 'Lee', 'Affiliation': 'Department of Research and Development, Posit Science Inc., San Francisco, CA.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Fisher', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Minnesota, Minneapolis, MN.'}, {'ForeName': 'Michael F', 'Initials': 'MF', 'LastName': 'Green', 'Affiliation': 'VA Greater Los Angeles, Los Angeles, CA.'}, {'ForeName': 'Christine I', 'Initials': 'CI', 'LastName': 'Hooker', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Rush University Medical Center, Chicago, IL.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Ventura', 'Affiliation': 'Department of Psychiatry and Biobehavioral Sciences, University of California, Los Angeles, CA.'}, {'ForeName': 'Joshua T', 'Initials': 'JT', 'LastName': 'Jordan', 'Affiliation': 'Department of Psychiatry, University of California, San Francisco, CA.'}, {'ForeName': 'Annika', 'Initials': 'A', 'LastName': 'Rose', 'Affiliation': 'Department of Research and Development, Posit Science Inc., San Francisco, CA.'}, {'ForeName': 'Sarah-Jane', 'Initials': 'SJ', 'LastName': 'Kim', 'Affiliation': 'Department of Research and Development, Posit Science Inc., San Francisco, CA.'}, {'ForeName': 'Kristen M', 'Initials': 'KM', 'LastName': 'Haut', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Rush University Medical Center, Chicago, IL.'}, {'ForeName': 'Michael M', 'Initials': 'MM', 'LastName': 'Merzenich', 'Affiliation': 'Department of Research and Development, Posit Science Inc., San Francisco, CA.'}, {'ForeName': 'Sophia', 'Initials': 'S', 'LastName': 'Vinogradov', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Minnesota, Minneapolis, MN.'}]",Schizophrenia bulletin,['10.1093/schbul/sbaa085'] 2609,32614141,Targeted Mass Spectrometry of a Clinically Relevant PSA Variant from Post-DRE Urines for Quantitation and Genotype Determination.,"PURPOSE The rs17632542 SNP results in lower serum PSA levels which may further mitigate against its clinical utility as a prostate cancer biomarker. Post-DRE urine is a minimally invasive fluid that is currently utilized in prostate cancer diagnosis. We have used targeted MS to detect and quantitate the variant protein in urine. EXPERIMENTAL DESIGN Fifty-three post-DRE urines from rs17632542 genotyped individuals were processed and analyzed by LC-MS in a double-blinded randomized study. The ability to distinguish between homozygous wild-type, heterozygous, or homozygous variant was examined before unblinding. RESULTS Stable-isotope labeled peptides were used in the detection and quantitation of three peptides of interest in each sample using an LC-MS-PRM method. Analysis of the raw data using Skyline allowed for peak detection and area extraction. Using these data, groupings were predicted using hierarchical clustering in R. Accuracy of the predictions showed 100% concordance across the 53 samples, including individuals homozygous and heterozygous for the SNP. CONCLUSIONS AND CLINICAL RELEVANCE The study demonstrates that MS based peptide variant quantitation in urine could be useful in determining patient genotype expression. Our assay provides a tool to evaluate the utility of PSA variant (rs17632542) assessment in parallel with current and forthcoming urine biomarker panels. This article is protected by copyright. All rights reserved.",2020,"Using these data, groupings were predicted using hierarchical clustering in R. Accuracy of the predictions showed 100% concordance across the 53 samples, including individuals homozygous and heterozygous for the SNP. ",['Fifty-three post-DRE urines from rs17632542 genotyped individuals'],[],"['peak detection and area extraction', 'serum PSA levels']","[{'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C1384593', 'cui_str': 'Digital examination of rectum'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0027361', 'cui_str': 'Person'}]",[],"[{'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0201544', 'cui_str': 'Prostate specific antigen measurement'}]",,0.0364145,"Using these data, groupings were predicted using hierarchical clustering in R. Accuracy of the predictions showed 100% concordance across the 53 samples, including individuals homozygous and heterozygous for the SNP. ","[{'ForeName': 'Joseph J', 'Initials': 'JJ', 'LastName': 'Otto', 'Affiliation': 'Leroy T. Canoles Jr. Cancer Research Center, Eastern Virginia Medical School, Norfolk, VA.'}, {'ForeName': 'Vanessa L', 'Initials': 'VL', 'LastName': 'Correll', 'Affiliation': 'Leroy T. Canoles Jr. Cancer Research Center, Eastern Virginia Medical School, Norfolk, VA.'}, {'ForeName': 'Hampus A', 'Initials': 'HA', 'LastName': 'Engstroem', 'Affiliation': 'Leroy T. Canoles Jr. Cancer Research Center, Eastern Virginia Medical School, Norfolk, VA.'}, {'ForeName': 'Naomi L', 'Initials': 'NL', 'LastName': 'Hitefield', 'Affiliation': 'Leroy T. Canoles Jr. Cancer Research Center, Eastern Virginia Medical School, Norfolk, VA.'}, {'ForeName': 'Brian P', 'Initials': 'BP', 'LastName': 'Main', 'Affiliation': 'Leroy T. Canoles Jr. Cancer Research Center, Eastern Virginia Medical School, Norfolk, VA.'}, {'ForeName': 'Brenna', 'Initials': 'B', 'LastName': 'Albracht', 'Affiliation': 'Department of Urology, The University of Texas Health San Antonio, San Antonio, TX.'}, {'ForeName': 'Teresa', 'Initials': 'T', 'LastName': 'Johnson-Pais', 'Affiliation': 'Department of Urology, The University of Texas Health San Antonio, San Antonio, TX.'}, {'ForeName': 'Li Fang', 'Initials': 'LF', 'LastName': 'Yang', 'Affiliation': 'Leroy T. Canoles Jr. Cancer Research Center, Eastern Virginia Medical School, Norfolk, VA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Liss', 'Affiliation': 'Department of Urology, The University of Texas Health San Antonio, San Antonio, TX.'}, {'ForeName': 'Paul C', 'Initials': 'PC', 'LastName': 'Boutros', 'Affiliation': 'Departments of Human Genetics and Urology, Jonsson Comprehensive Cancer Center, Institute for Precision Health University of California Los Angeles, Los Angeles, CA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Kislinger', 'Affiliation': 'University of Toronto, Department of Medical Biophysics, Toronto, ON.'}, {'ForeName': 'Robin J', 'Initials': 'RJ', 'LastName': 'Leach', 'Affiliation': 'Department of Urology, The University of Texas Health San Antonio, San Antonio, TX.'}, {'ForeName': 'O John', 'Initials': 'OJ', 'LastName': 'Semmes', 'Affiliation': 'Leroy T. Canoles Jr. Cancer Research Center, Eastern Virginia Medical School, Norfolk, VA.'}, {'ForeName': 'Julius O', 'Initials': 'JO', 'LastName': 'Nyalwidhe', 'Affiliation': 'Leroy T. Canoles Jr. Cancer Research Center, Eastern Virginia Medical School, Norfolk, VA.'}]",Proteomics. Clinical applications,['10.1002/prca.202000012'] 2610,32607749,"Low-dose IL-2 in children with recently diagnosed type 1 diabetes: a Phase I/II randomised, double-blind, placebo-controlled, dose-finding study.","AIMS/HYPOTHESIS Low-dose IL-2 (ld-IL2) selectively activates and expands regulatory T cells (Tregs) and thus has the potential to skew the regulatory/effector T (Treg/Teff) cell balance towards improved regulation. We investigated which low doses of IL-2 would more effectively and safely activate Tregs during a 1 year treatment in children with recently diagnosed type 1 diabetes. METHODS Dose Finding Study of IL-2 at Ultra-low Dose in Children With Recently Diagnosed Type 1 Diabetes (DF-IL2-Child) was a multicentre, double-blinded, placebo-controlled, dose-finding Phase I/II clinical trial conducted in four centres at university hospitals in France: 24 children (7-14 years old) with type 1 diabetes diagnosed within the previous 3 months were randomly assigned 1:1:1:1 to treatment by a centralised randomisation system, leading to a 7/5/6/6 patient distribution of placebo or IL-2 at doses of 0.125, 0.250 or 0.500 million international units (MIU)/m 2 , given daily for a 5 day course and then fortnightly for 1 year. A study number was attributed to patients by an investigator unaware of the randomisation list and all participants as well as investigators and staff involved in the study conduct and analyses were blinded to treatments. The primary outcome was change in Tregs, expressed as a percentage of CD4 + T cells at day 5. It pre-specified that a ≥60% increase in Tregs from baseline would identify Treg high responders. RESULTS There were no serious adverse events. Non-serious adverse events (NSAEs) were transient and mild to moderate. In treated patients vs placebo, the commonest NSAE was injection site reaction (37.9% vs 3.4%), whereas other NSAEs were at the same level (23.3% vs 19.2%). ld-IL2 induced a dose-dependent increase in the mean proportion of Tregs, from 23.9% (95% CI -11.8, 59.6) at the lowest to 77.2% (44.7, 109.8) at the highest dose, which was significantly different from placebo for all dose groups. However, the individual Treg responses to IL-2 were variable and fluctuated over time. Seven patients, all among those treated with the 0.250 and 0.500 MIU m -2  day -1 doses, were Treg high responders. At baseline, they had lower Treg proportions in CD4 + cells than Treg low responders, and serum soluble IL-2 receptor α (sIL-2RA) and vascular endothelial growth factor receptor 2 (VEGFR2) levels predicted the Treg response after the 5 day course. There was no significant change in glycaemic control in any of the dose groups compared with placebo. However, there was an improved maintenance of induced C-peptide production at 1 year in the seven Treg high responders as compared with low responders. CONCLUSIONS/INTERPRETATION The safety profile at all doses, the dose-dependent effects on Tregs and the observed variability of the Treg response to ld-IL2 in children with newly diagnosed type 1 diabetes call for use of the highest dose in future developments. The better preservation of insulin production in Treg high responders supports the potential of Tregs in regulating autoimmunity in type 1 diabetes, and warrants pursuing the investigation of ld-IL2 for its treatment and prevention. TRIAL REGISTRATION ClinicalTrials.gov NCT01862120. FUNDING Assistance Publique-Hôpitaux de Paris, Investissements d'Avenir programme (ANR-11-IDEX-0004-02, LabEx Transimmunom and ANR-16-RHUS-0001, RHU iMAP) and European Research Council Advanced Grant (FP7-IDEAS-ERC-322856, TRiPoD).",2020,There were no serious adverse events.,"['four centres at university hospitals in France: 24 children (7-14\xa0years old) with type 1 diabetes diagnosed within the previous 3\xa0months', 'children with newly diagnosed type 1 diabetes', 'children with recently diagnosed type 1 diabetes', 'Children']","['IL-2', 'Low-dose IL-2', 'placebo or IL-2', 'placebo']","['serum soluble IL-2 receptor α (sIL-2RA) and', 'mean proportion of Tregs', 'vascular endothelial growth factor receptor 2 (VEGFR2) levels', 'serious adverse events', 'injection site reaction', 'glycaemic control', 'change in Tregs, expressed as a percentage of CD4 + T cells', 'maintenance of induced C-peptide production']","[{'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0332185', 'cui_str': 'Recent'}]","[{'cui': 'C0021756', 'cui_str': 'Interleukin-2'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0034819', 'cui_str': 'Interleukin-2 receptor'}, {'cui': 'C0257766', 'cui_str': 'SILV protein, human'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0378796', 'cui_str': 'KDR Tyrosine Kinase'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0151735', 'cui_str': 'Injection site reaction'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0003323', 'cui_str': 'Lymphocyte antigen CD4'}, {'cui': 'C0039194', 'cui_str': 'T lymphocyte'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0006558', 'cui_str': 'C-peptide'}]",,0.490362,There were no serious adverse events.,"[{'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Rosenzwajg', 'Affiliation': ""Clinical Investigation Center for Biotherapies and Inflammation-Immunopathology-Biotherapy Department (i2B), AP-HP.Sorbonne Université, Pitié-Salpêtrière Hospital, 83 Bd de l'Hôpital, F-75013, Paris, France.""}, {'ForeName': 'Randa', 'Initials': 'R', 'LastName': 'Salet', 'Affiliation': 'Department of Paediatrics, Nîmes University Hospital and Inserm U1183, Montpellier University, Montpellier, France.'}, {'ForeName': 'Roberta', 'Initials': 'R', 'LastName': 'Lorenzon', 'Affiliation': ""Clinical Investigation Center for Biotherapies and Inflammation-Immunopathology-Biotherapy Department (i2B), AP-HP.Sorbonne Université, Pitié-Salpêtrière Hospital, 83 Bd de l'Hôpital, F-75013, Paris, France.""}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Tchitchek', 'Affiliation': ""Clinical Investigation Center for Biotherapies and Inflammation-Immunopathology-Biotherapy Department (i2B), AP-HP.Sorbonne Université, Pitié-Salpêtrière Hospital, 83 Bd de l'Hôpital, F-75013, Paris, France.""}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Roux', 'Affiliation': ""Clinical Investigation Center for Biotherapies and Inflammation-Immunopathology-Biotherapy Department (i2B), AP-HP.Sorbonne Université, Pitié-Salpêtrière Hospital, 83 Bd de l'Hôpital, F-75013, Paris, France.""}, {'ForeName': 'Claude', 'Initials': 'C', 'LastName': 'Bernard', 'Affiliation': ""Clinical Investigation Center for Biotherapies and Inflammation-Immunopathology-Biotherapy Department (i2B), AP-HP.Sorbonne Université, Pitié-Salpêtrière Hospital, 83 Bd de l'Hôpital, F-75013, Paris, France.""}, {'ForeName': 'Jean-Claude', 'Initials': 'JC', 'LastName': 'Carel', 'Affiliation': ""Department of Paediatric Endocrinology and Diabetology, and Centre de Référence des Pathologies Rares de l'Insulino-Sécrétion et de l'Insulino-Sensibilité, Robert-Debré Hospital, AP-HP Nord-Université de Paris Diderot & UFR de Médecine Paris Diderot, Paris, France.""}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Storey', 'Affiliation': ""Department of Paediatric Endocrinology and Diabetology, and Centre de Référence des Pathologies Rares de l'Insulino-Sécrétion et de l'Insulino-Sensibilité, Robert-Debré Hospital, AP-HP Nord-Université de Paris Diderot & UFR de Médecine Paris Diderot, Paris, France.""}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Polak', 'Affiliation': ""Department of Paediatric Endocrinology, Gynecology and Diabetology, and Centre de Référence des Pathologies Rares de l'Insulino-Sécrétion et de l'Insulino-Sensibilité, Necker Enfants Malades Hospital, AP-HP.Centre & Université de Paris, UFR de Médecine Paris Descartes, Paris, France.""}, {'ForeName': 'Jacques', 'Initials': 'J', 'LastName': 'Beltrand', 'Affiliation': ""Department of Paediatric Endocrinology, Gynecology and Diabetology, and Centre de Référence des Pathologies Rares de l'Insulino-Sécrétion et de l'Insulino-Sensibilité, Necker Enfants Malades Hospital, AP-HP.Centre & Université de Paris, UFR de Médecine Paris Descartes, Paris, France.""}, {'ForeName': 'Chloé', 'Initials': 'C', 'LastName': 'Amouyal', 'Affiliation': 'Department of Diabetology, Pitié-Salpêtrière Hospital, AP-HP. Sorbonne Université, Paris, France.'}, {'ForeName': 'Agnès', 'Initials': 'A', 'LastName': 'Hartemann', 'Affiliation': 'Department of Diabetology, Pitié-Salpêtrière Hospital, AP-HP. Sorbonne Université, Paris, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Corbeau', 'Affiliation': 'Immunology Department, Nîmes University Hospital, Nîmes, France.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Vicaut', 'Affiliation': 'Lariboisière Hospital, Clinical Trial Unit, AP-HP.Nord, Paris, France.'}, {'ForeName': 'Cecile', 'Initials': 'C', 'LastName': 'Bibal', 'Affiliation': 'Department of Paediatric Endocrinology, Bicêtre Hospital, AP-HP.Université Paris Saclay, Le Kremlin-Bicêtre, France.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Bougnères', 'Affiliation': 'Department of Paediatric Endocrinology, Bicêtre Hospital, AP-HP.Université Paris Saclay, Le Kremlin-Bicêtre, France.'}, {'ForeName': 'Tu-Anh', 'Initials': 'TA', 'LastName': 'Tran', 'Affiliation': 'Department of Paediatrics, Nîmes University Hospital and Inserm U1183, Montpellier University, Montpellier, France.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Klatzmann', 'Affiliation': ""Clinical Investigation Center for Biotherapies and Inflammation-Immunopathology-Biotherapy Department (i2B), AP-HP.Sorbonne Université, Pitié-Salpêtrière Hospital, 83 Bd de l'Hôpital, F-75013, Paris, France. david.klatzmann@sorbonne-universite.fr.""}]",Diabetologia,['10.1007/s00125-020-05200-w'] 2611,32607784,10 kHz spinal cord stimulation for chronic upper limb and neck pain: Australian experience.,"PURPOSE Intractable upper limb and neck pain has traditionally been a challenging pain condition to treat, with conventional spinal cord stimulation (SCS) often inducing positional variation in paraesthesia and/or inadequate coverage of axial neck pain. The purpose of this Australian multi-centre prospective, clinical trial was to assess the safety and effectiveness of paraesthesia-independent 10 kHz SCS for the treatment of upper limb and neck pain. METHODS Subjects with chronic, intractable neck and/or upper limb pain of ≥ 5 cm (on a 0-10-cm visual analogue scale) were enrolled (ACTRN12614000153617) following human research ethics committee approval. Subjects were implanted with two epidural leads spanning C2-C6 vertebral bodies. Subjects with successful trial stimulation were implanted with a Senza ® system (Nevro Corp., Redwood City, CA, USA) and included in the safety and effectiveness evaluation at 3 months post-implant (primary endpoint assessment, PEA) and followed to 12 months. RESULTS Overall, 31/38 (82.6%) subjects reported a successful 10 kHz SCS trial and proceeded to a permanent implant. Twenty-three of 30 subjects (76.7%) met the PEA. Subjects reported a reduction in neck pain and upper limb pain from baseline at the PEA (8.1 ± 0.2 cm vs. 2.9 ± 0.5 cm, 7.3 ± 0.3 cm vs. 2.5 ± 0.5 cm, respectively, p ≤ 0.0001). Disability, as measured by pain disability index score, decreased from 42.6 ± 2.6 at baseline to 22.7 ± 3.2 at PEA. Results were maintained 12 months post-implant. No neurological deficits, nor reports of paraesthesia, were observed. CONCLUSIONS Stable, long-term results demonstrated that 10 kHz SCS is a promising therapy option for intractable chronic upper limb and neck pain.",2020,"Disability, as measured by pain disability index score, decreased from 42.6 ± 2.6 at baseline to 22.7 ± 3.2 at PEA.","['Twenty-three of 30 subjects (76.7%) met the PEA', 'Subjects with successful trial stimulation', 'Subjects with chronic, intractable neck and/or upper limb pain of\u2009≥\u20095\xa0cm (on a 0-10-cm visual analogue scale']","['10\xa0kHz spinal cord stimulation', 'kHz SCS', 'paraesthesia-independent 10\xa0kHz SCS', 'conventional spinal cord stimulation (SCS']","['neck pain and upper limb pain', 'pain disability index score', 'Disability', 'neurological deficits, nor reports of paraesthesia']","[{'cui': 'C0450348', 'cui_str': '23'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0030738', 'cui_str': 'Peas'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0239377', 'cui_str': 'Pain in upper limb'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]","[{'cui': 'C0556965', 'cui_str': 'kHz'}, {'cui': 'C0394477', 'cui_str': 'Neurostimulation of spinal cord tissue'}, {'cui': 'C0030554', 'cui_str': 'Paresthesia'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}]","[{'cui': 'C0007859', 'cui_str': 'Neck pain'}, {'cui': 'C0239377', 'cui_str': 'Pain in upper limb'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0521654', 'cui_str': 'Motor dysfunction'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0030554', 'cui_str': 'Paresthesia'}]",30.0,0.087611,"Disability, as measured by pain disability index score, decreased from 42.6 ± 2.6 at baseline to 22.7 ± 3.2 at PEA.","[{'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Verrills', 'Affiliation': 'Metro Pain Group, Clayton, VIC, Australia.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Salmon', 'Affiliation': 'PainCare, Perth, WA, Australia.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Russo', 'Affiliation': 'Genesis Research Services, Broadmeadow, NSW, Australia.'}, {'ForeName': 'Bradford', 'Initials': 'B', 'LastName': 'Gliner', 'Affiliation': 'Nevro Corp, Redwood City, CA, USA.'}, {'ForeName': 'Adele', 'Initials': 'A', 'LastName': 'Barnard', 'Affiliation': 'Nevro Corp, Redwood City, CA, USA. adele.barnard@nevro.com.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Caraway', 'Affiliation': 'Nevro Corp, Redwood City, CA, USA.'}]","European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society",['10.1007/s00586-020-06480-x'] 2612,32607803,Perfusion in hand arthritis on dynamic contrast-enhanced computed tomography: a randomized prospective study using MRI as a standard of reference.,"OBJECTIVE To evaluate the performance of dynamic contrast-enhanced CT (DCE-CT) in detecting and quantitatively assessing perfusion parameters in patients with arthritis of the hand compared with dynamic contrast-enhanced MRI (DCE-MRI) as a standard of reference. MATERIALS AND METHODS In this IRB-approved randomized prospective single-centre study, 36 consecutive patients with suspected rheumatoid arthritis underwent DCE-CT (320-row, tube voltage 80 kVp, tube current 8.25 mAs) and DCE-MRI (1.5 T) of the hand. Perfusion maps were calculated separately for mean transit time (MTT), time to peak (TTP), relative blood volume (rBV), and relative blood flow (rBF) using four different decomposition techniques. Region of interest (ROI) analysis was performed in metacarpophalangeal joints II-V and in the wrist. Pairs of perfusion parameters in DCE-CT and DCE-MRI were compared using a two-tailed t test for paired samples and interpreted for effect size (Cohen's d). According to the Rheumatoid Arthritis Magnetic Resonance Imaging Score (RAMRIS) scoring results, differentiation of synovitis-positive and synovitis-negative joints with both modalities was assessed with the independent t test. RESULTS The two modalities yielded similar perfusion parameters. Identified differences had small effects (d 0.01-0.4). DCE-CT additionally differentiates inflamed and noninflamed joints based on rBF and rBV but tends to underestimate these parameters in severe inflammation. The total dose-length product (DLP) was 48 mGy*cm with an estimated effective dose of 0.038 mSv. CONCLUSION DCE-CT is a promising imaging technique in arthritis. In patients with a contraindication to MRI or when MRI is not available, DCE-CT is a suitable alternative to detect and assess arthritis.",2020,DCE-CT additionally differentiates inflamed and noninflamed joints based on rBF and rBV but tends to underestimate these parameters in severe inflammation.,"['36 consecutive patients with suspected rheumatoid arthritis underwent', 'patients with arthritis of the hand compared with dynamic contrast-enhanced MRI (DCE-MRI']","['dynamic contrast-enhanced computed tomography', 'dynamic contrast-enhanced CT (DCE-CT', 'DCE-CT', 'DCE-CT (320-row, tube voltage 80\xa0kVp, tube current 8.25\xa0mAs) and DCE-MRI']","['total dose-length product (DLP', 'mean transit time (MTT), time to peak (TTP), relative blood volume (rBV), and relative blood flow (rBF']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0003873', 'cui_str': 'Rheumatoid arthritis'}, {'cui': 'C0409208', 'cui_str': 'Arthritis of hand'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}]","[{'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0009924', 'cui_str': 'Contrast media'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C4517711', 'cui_str': '320'}, {'cui': 'C0175730', 'cui_str': 'Tube'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1301827', 'cui_str': 'In transit'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0005850', 'cui_str': 'Blood volume'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}]",36.0,0.0411065,DCE-CT additionally differentiates inflamed and noninflamed joints based on rBF and rBV but tends to underestimate these parameters in severe inflammation.,"[{'ForeName': 'Sevtap Tugce', 'Initials': 'ST', 'LastName': 'Ulas', 'Affiliation': 'Department of Radiology, Charité - Universitätsmedizin Berlin, Campus Mitte, Humboldt - Universität zu Berlin, Freie Universität Berlin, Berlin, Germany.'}, {'ForeName': 'Kay Geert', 'Initials': 'KG', 'LastName': 'Hermann', 'Affiliation': 'Department of Radiology, Charité - Universitätsmedizin Berlin, Campus Mitte, Humboldt - Universität zu Berlin, Freie Universität Berlin, Berlin, Germany.'}, {'ForeName': 'Marcus R', 'Initials': 'MR', 'LastName': 'Makowski', 'Affiliation': 'Department of Radiology, Charité - Universitätsmedizin Berlin, Campus Mitte, Humboldt - Universität zu Berlin, Freie Universität Berlin, Berlin, Germany.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Biesen', 'Affiliation': 'Department of Rheumatology, Charité - Universitätsmedizin Berlin, Campus Mitte, Humboldt - Universität zu Berlin, Freie Universität Berlin, Berlin, Germany.'}, {'ForeName': 'Fabian', 'Initials': 'F', 'LastName': 'Proft', 'Affiliation': 'Department of Rheumatology, Charité - Universitätsmedizin Berlin, Campus Benjamin Franklin, Humboldt - Universität zu Berlin, Freie Universität Berlin, Berlin, Germany.'}, {'ForeName': 'Ralph', 'Initials': 'R', 'LastName': 'Schilling', 'Affiliation': 'Institute of Biometry and Clinical Epidemiology, Charité - Universitätsmedizin Berlin, Campus Mitte, Humboldt - Universität zu Berlin, Freie Universität Berlin, Berlin, Germany.'}, {'ForeName': 'Torsten', 'Initials': 'T', 'LastName': 'Diekhoff', 'Affiliation': 'Department of Radiology, Charité - Universitätsmedizin Berlin, Campus Mitte, Humboldt - Universität zu Berlin, Freie Universität Berlin, Berlin, Germany. torsten.diekhoff@charite.de.'}]",Skeletal radiology,['10.1007/s00256-020-03526-5'] 2613,31896302,Dancing: More than a therapy for patients with venous insufficiency.,,2020,,['patients with venous insufficiency'],[],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0042485', 'cui_str': 'Peripheral venous insufficiency'}]",[],[],,0.0239979,,"[{'ForeName': 'Esra', 'Initials': 'E', 'LastName': 'Dogru-Huzmeli', 'Affiliation': 'Health Science Faculty, Physiotherapy and Rehabilitation Department, Hatay Mustafa Kemal University, Hatay, Turkey.'}, {'ForeName': 'Iyad', 'Initials': 'I', 'LastName': 'Fansa', 'Affiliation': 'Tayfur Ata Sokmen Medical Faculty, Department of Cardiovascular Surgery, Hatay Mustafa Kemal University, Hatay, Turkey.'}, {'ForeName': 'Nilufer', 'Initials': 'N', 'LastName': 'Cetisli-Korkmaz', 'Affiliation': 'School of Physical Therapy and Rehabilitation, Pamukkale University, Hatay, Turkey.'}, {'ForeName': 'Gul', 'Initials': 'G', 'LastName': 'Oznur-Karabicak', 'Affiliation': 'Health Science Faculty, Department of Physiotherapy and Rehabilitation, Adnan Menderes University, Aydin, Turkey.'}, {'ForeName': 'Cem', 'Initials': 'C', 'LastName': 'Lale', 'Affiliation': 'Tayfur Ata Sokmen Medical Faculty, Department of Cardiovascular Surgery, Hatay Mustafa Kemal University, Hatay, Turkey.'}, {'ForeName': 'Ozden', 'Initials': 'O', 'LastName': 'Gokcek', 'Affiliation': 'Health Science Faculty, Physiotherapy and Rehabilitation Department, Hatay Mustafa Kemal University, Hatay, Turkey.'}, {'ForeName': 'Yagmur', 'Initials': 'Y', 'LastName': 'Cam', 'Affiliation': 'Health Science Faculty, Physiotherapy and Rehabilitation Department, Hatay Mustafa Kemal University, Hatay, Turkey.'}]",Vascular,['10.1177/1708538119893534'] 2614,31986094,Effects of Omega-3 Fatty Acid Supplements on Arrhythmias.,,2020,,[],['Omega-3 Fatty Acid Supplements'],['Arrhythmias'],[],"[{'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}]","[{'cui': 'C0003811', 'cui_str': 'Cardiac arrhythmia'}]",,0.0209951,,"[{'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Parish', 'Affiliation': 'Medical Research Council Population Health Research Unit (S.P., R.H., L.B., J.A.), Nuffield Department of Population Health, University of Oxford, United Kingdom.'}, {'ForeName': 'Marion', 'Initials': 'M', 'LastName': 'Mafham', 'Affiliation': 'Clinical Trial Service Unit and Epidemiological Studies Unit (S.P., M.M., A.O., J.B., K.W., W.S., G.B., R.H., R.C., L.B., J.A.), Nuffield Department of Population Health, University of Oxford, United Kingdom.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Offer', 'Affiliation': 'Clinical Trial Service Unit and Epidemiological Studies Unit (S.P., M.M., A.O., J.B., K.W., W.S., G.B., R.H., R.C., L.B., J.A.), Nuffield Department of Population Health, University of Oxford, United Kingdom.'}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Barton', 'Affiliation': 'Clinical Trial Service Unit and Epidemiological Studies Unit (S.P., M.M., A.O., J.B., K.W., W.S., G.B., R.H., R.C., L.B., J.A.), Nuffield Department of Population Health, University of Oxford, United Kingdom.'}, {'ForeName': 'Karl', 'Initials': 'K', 'LastName': 'Wallendszus', 'Affiliation': 'Clinical Trial Service Unit and Epidemiological Studies Unit (S.P., M.M., A.O., J.B., K.W., W.S., G.B., R.H., R.C., L.B., J.A.), Nuffield Department of Population Health, University of Oxford, United Kingdom.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Stevens', 'Affiliation': 'Clinical Trial Service Unit and Epidemiological Studies Unit (S.P., M.M., A.O., J.B., K.W., W.S., G.B., R.H., R.C., L.B., J.A.), Nuffield Department of Population Health, University of Oxford, United Kingdom.'}, {'ForeName': 'Georgina', 'Initials': 'G', 'LastName': 'Buck', 'Affiliation': 'Clinical Trial Service Unit and Epidemiological Studies Unit (S.P., M.M., A.O., J.B., K.W., W.S., G.B., R.H., R.C., L.B., J.A.), Nuffield Department of Population Health, University of Oxford, United Kingdom.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Haynes', 'Affiliation': 'Medical Research Council Population Health Research Unit (S.P., R.H., L.B., J.A.), Nuffield Department of Population Health, University of Oxford, United Kingdom.'}, {'ForeName': 'Rory', 'Initials': 'R', 'LastName': 'Collins', 'Affiliation': 'Clinical Trial Service Unit and Epidemiological Studies Unit (S.P., M.M., A.O., J.B., K.W., W.S., G.B., R.H., R.C., L.B., J.A.), Nuffield Department of Population Health, University of Oxford, United Kingdom.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Bowman', 'Affiliation': 'Medical Research Council Population Health Research Unit (S.P., R.H., L.B., J.A.), Nuffield Department of Population Health, University of Oxford, United Kingdom.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Armitage', 'Affiliation': 'Medical Research Council Population Health Research Unit (S.P., R.H., L.B., J.A.), Nuffield Department of Population Health, University of Oxford, United Kingdom.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Circulation,['10.1161/CIRCULATIONAHA.119.044165'] 2615,31301609,"The validity of daily patient-reported anxiety measured using smartphones and the association with stress, quality of life and functioning in patients with bipolar disorder.","BACKGROUND More than half of patients with bipolar disorder (BD) experience anxiety, which is associated with impaired functioning. In patients with BD, the present study aimed (1) to validate daily patient-reported symptoms of anxiety measured using smartphones against clinically rated symptoms of anxiety, (2) to estimate the prevalence of anxiety symptoms, and (3) to investigate the associations between patient-reported anxiety symptoms and stress, quality of life and functioning. METHODS A total of 84 patients with BD evaluated their anxiety symptoms daily for nine months using a smartphone-based system. Data on clinically evaluated symptoms of anxiety and functioning and patient-reported stress and quality of life were collected from each patient at five fixed time points during follow-up. RESULTS The patients presented mild affective symptoms only. The reporting of anxiety symptoms was evaluated for validity according to clinically evaluated anxiety scores based on the two anxiety sub-items of the Hamilton Depression Rating Scale. The patients experienced symptoms of anxiety 19.3% of the time. There were statistically significant associations between anxiety and stress, quality of life and functioning (all p-values < 0.0001). CONCLUSION In patients with BD in full or partial remission, the self-reporting of anxiety symptoms using smartphones was validated. Anxiety is associated with increased stress, decreased quality of life and functioning even during full or partial remission. Identifying anxiety symptoms thus has clinical impact, which suggests that smartphones may serve as a valid tool.",2019,"There were statistically significant associations between anxiety and stress, quality of life and functioning (all p-values < 0.0001). ","['84 patients with BD evaluated their anxiety symptoms daily for nine months using a smartphone-based system', 'patients with bipolar disorder', 'patients with bipolar disorder (BD) experience anxiety']",[],"['anxiety and functioning and patient-reported stress and quality of life', 'reporting of anxiety symptoms', 'quality of life and functioning', 'anxiety and stress, quality of life and functioning', 'Hamilton Depression Rating Scale']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0005586', 'cui_str': 'Bipolar disorder'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]",[],"[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}]",84.0,0.0695727,"There were statistically significant associations between anxiety and stress, quality of life and functioning (all p-values < 0.0001). ","[{'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Faurholt-Jepsen', 'Affiliation': 'Copenhagen Affective Disorder Research Center (CADIC), Psychiatric Center Copenhagen, Rigshospitalet, Blegdamsvej 9, DK- 2100 Copenhagen, Denmark. Electronic address: maria@faurholt-jepsen.dk.'}, {'ForeName': 'Mads', 'Initials': 'M', 'LastName': 'Frost', 'Affiliation': 'Monsenso Aps, Torveporten 2, Valby, Denmark.'}, {'ForeName': 'Ellen Margrethe', 'Initials': 'EM', 'LastName': 'Christensen', 'Affiliation': 'Copenhagen Affective Disorder Research Center (CADIC), Psychiatric Center Copenhagen, Rigshospitalet, Blegdamsvej 9, DK- 2100 Copenhagen, Denmark.'}, {'ForeName': 'Jakob E', 'Initials': 'JE', 'LastName': 'Bardram', 'Affiliation': 'Department of Applied Mathematics and Computer Science, Technical University of Denmark, Lyngby, Denmark.'}, {'ForeName': 'Maj', 'Initials': 'M', 'LastName': 'Vinberg', 'Affiliation': 'Copenhagen Affective Disorder Research Center (CADIC), Psychiatric Center Copenhagen, Rigshospitalet, Blegdamsvej 9, DK- 2100 Copenhagen, Denmark.'}, {'ForeName': 'Lars Vedel', 'Initials': 'LV', 'LastName': 'Kessing', 'Affiliation': 'Copenhagen Affective Disorder Research Center (CADIC), Psychiatric Center Copenhagen, Rigshospitalet, Blegdamsvej 9, DK- 2100 Copenhagen, Denmark.'}]",Journal of affective disorders,['10.1016/j.jad.2019.07.029'] 2616,32603956,Leptin mediates improvements in cognitive function following treatment with infliximab in adults with bipolar depression.,"A potential role for leptin in the pathophysiology of bipolar disorder (BD) has been proposed. We recently investigated the effects of the tumor necrosis factor-alpha (TNF-α) antagonist infliximab in individuals with bipolar depression. Leptin is known to interact with the TNF-α system. Herein, we aimed to explore infliximab's effects on leptin and its relationship with brain structure and function. Sixty adults with bipolar depression were enrolled in this randomized, double-blind, 12-week clinical trial of adjunctive infliximab (n = 29) and saline control (n = 31), which were administered intravenously at weeks 0, 2, and 6. Plasma concentrations of leptin, TNF-α and soluble TNF receptors (sTNFR) 1 and 2 were assessed at weeks 0, 2, 6, and 12. We observed a significant decrease in leptin levels in infliximab-treated patients, relative to placebo. Infliximab treatment also significantly reduced TNF-α and sTNFR2, but not sTNFR1 levels. Changes in sTNR2 levels at week 6 significantly determined changes in leptin at week 12 in infliximab-, but not placebo-treated participants. Improvements in verbal memory and increases in global cortical volume were associated with reduction in leptin levels in the treatment group. Mediation analysis indicated that cognitive improvement in infliximab-treated patients was mediated by reductions in leptin levels, which in its turn were determined by decreases in sTNR2 levels. In conclusion, infliximab treatment reduced plasma leptin levels in individuals with BD, through modulation of sTNFR2. Decreases in leptin signaling were associated with an increase in global cortical volume and better performance in a verbal memory task.",2020,"Infliximab treatment also significantly reduced TNF-α and sTNFR2, but not sTNFR1 levels.","['Sixty adults with bipolar depression', 'individuals with BD', 'adults with bipolar depression', 'individuals with bipolar depression']","['Leptin', 'saline control', 'adjunctive infliximab', 'infliximab', 'Infliximab', 'tumor necrosis factor-alpha (TNF-α) antagonist infliximab', 'placebo']","['leptin', 'cognitive improvement', 'global cortical volume and better performance in a verbal memory task', 'cognitive function', 'Plasma concentrations of leptin, TNF-α and soluble TNF receptors (sTNFR', 'verbal memory', 'plasma leptin levels', 'global cortical volume', 'leptin signaling', 'leptin levels', 'TNF-α and sTNFR2', 'sTNR2 levels']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0005587', 'cui_str': 'Bipolar affective disorder, current episode depression'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0005586', 'cui_str': 'Bipolar disorder'}]","[{'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0666743', 'cui_str': 'infliximab'}, {'cui': 'C1168005', 'cui_str': 'Alpha tumour necrosis factor'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0231491', 'cui_str': 'Antagonist muscle action'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0561770', 'cui_str': 'Verbal memory observable'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0077503', 'cui_str': 'Tumor Necrosis Factor Receptor'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",60.0,0.149116,"Infliximab treatment also significantly reduced TNF-α and sTNFR2, but not sTNFR1 levels.","[{'ForeName': 'Rodrigo B', 'Initials': 'RB', 'LastName': 'Mansur', 'Affiliation': 'Mood Disorders Psychopharmacology Unit, University Health Network, Toronto, ON, Canada; Department of Psychiatry, University of Toronto, Toronto, ON, Canada. Electronic address: rodrigo.mansur@uhn.ca.'}, {'ForeName': 'Mehala', 'Initials': 'M', 'LastName': 'Subramaniapillai', 'Affiliation': 'Mood Disorders Psychopharmacology Unit, University Health Network, Toronto, ON, Canada.'}, {'ForeName': 'Yena', 'Initials': 'Y', 'LastName': 'Lee', 'Affiliation': 'Mood Disorders Psychopharmacology Unit, University Health Network, Toronto, ON, Canada; Institute of Medical Science, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Zihang', 'Initials': 'Z', 'LastName': 'Pan', 'Affiliation': 'Mood Disorders Psychopharmacology Unit, University Health Network, Toronto, ON, Canada.'}, {'ForeName': 'Nicole E', 'Initials': 'NE', 'LastName': 'Carmona', 'Affiliation': 'Mood Disorders Psychopharmacology Unit, University Health Network, Toronto, ON, Canada; Department of Psychology, Ryerson University, Toronto, ON, Canada.'}, {'ForeName': 'Margarita', 'Initials': 'M', 'LastName': 'Shekotikhina', 'Affiliation': 'Mood Disorders Psychopharmacology Unit, University Health Network, Toronto, ON, Canada; University of Ottawa, Department of Psychiatry, Ottawa, ON, Canada.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Iacobucci', 'Affiliation': 'Mood Disorders Psychopharmacology Unit, University Health Network, Toronto, ON, Canada.'}, {'ForeName': 'Nelson', 'Initials': 'N', 'LastName': 'Rodrigues', 'Affiliation': 'Mood Disorders Psychopharmacology Unit, University Health Network, Toronto, ON, Canada.'}, {'ForeName': 'Flora', 'Initials': 'F', 'LastName': 'Nasri', 'Affiliation': 'Mood Disorders Psychopharmacology Unit, University Health Network, Toronto, ON, Canada.'}, {'ForeName': 'Houman', 'Initials': 'H', 'LastName': 'Rashidian', 'Affiliation': 'Mood Disorders Psychopharmacology Unit, University Health Network, Toronto, ON, Canada; Department of Psychiatry, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Joshua D', 'Initials': 'JD', 'LastName': 'Rosenblat', 'Affiliation': 'Mood Disorders Psychopharmacology Unit, University Health Network, Toronto, ON, Canada; Department of Psychiatry, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Brietzke', 'Affiliation': ""Mood Disorders Psychopharmacology Unit, University Health Network, Toronto, ON, Canada; Kingston General Hospital, Providence Care Hospital, Department of Psychiatry, Queen's University School of Medicine, Kingston, ON, Canada.""}, {'ForeName': 'Victoria E', 'Initials': 'VE', 'LastName': 'Cosgrove', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Stanford University, School of Medicine, Palo Alto, CA, USA.'}, {'ForeName': 'Nicole E', 'Initials': 'NE', 'LastName': 'Kramer', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Stanford University, School of Medicine, Palo Alto, CA, USA.'}, {'ForeName': 'Trisha', 'Initials': 'T', 'LastName': 'Suppes', 'Affiliation': 'Department of Psychiatry & Behavioral Sciences, Stanford University, School of Medicine, Palo Alto, CA, USA.'}, {'ForeName': 'Roger S', 'Initials': 'RS', 'LastName': 'McIntyre', 'Affiliation': 'Mood Disorders Psychopharmacology Unit, University Health Network, Toronto, ON, Canada; Department of Psychiatry, University of Toronto, Toronto, ON, Canada; Institute of Medical Science, University of Toronto, Toronto, ON, Canada.'}]",Psychoneuroendocrinology,['10.1016/j.psyneuen.2020.104779'] 2617,32603994,A randomized-controlled examination of the effect of cognitive reappraisal instruction on maternal accommodation of child anxiety symptoms.,"Parental accommodation plays a key role in the maintenance of child anxiety, yet much of the research to date has been correlational, making it difficult to draw conclusions about underlying mechanisms. Given preliminary evidence that parental beliefs play a role in parental accommodation, the present study sought to experimentally reduce accommodation by targeting parental attitudes about child anxiety. Mothers of children ages 4-9 (N = 47) were randomly assigned to either receive brief instruction in cognitive reappraisal (EXP) or to a control intervention in which they received no instruction (CON). At pre- and post-intervention mothers were presented with bogus information that their child was experiencing varying levels of distress while completing a task in a nearby room. Maternal distress, negative affect and perceived likelihood of accommodation in the context of child distress were measured pre- and post-intervention. EXP mothers reported greater pre- to post-intervention decreases in distress and perceived likelihood of accommodation, compared to CON mothers. EXP and CON mothers showed similar changes in negative affect. Findings from this study provide preliminary experimental evidence that targeting maternal beliefs about child anxiety can result in changes in maternal distress and behavior following exposure to child distress. Implications for prevention and treatment are discussed.",2020,"EXP mothers reported greater pre- to post-intervention decreases in distress and perceived likelihood of accommodation, compared to CON mothers.",['Mothers of children ages 4-9 (N = 47'],"['cognitive reappraisal instruction', 'brief instruction in cognitive reappraisal (EXP) or to a control intervention in which they received no instruction (CON']","['distress and perceived likelihood of accommodation', 'Maternal distress, negative affect and perceived likelihood of accommodation in the context of child distress', 'maternal accommodation of child anxiety symptoms']","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0473485', 'cui_str': 'Maternal distress'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0449255', 'cui_str': 'Context'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}]",47.0,0.050831,"EXP mothers reported greater pre- to post-intervention decreases in distress and perceived likelihood of accommodation, compared to CON mothers.","[{'ForeName': 'Erin E', 'Initials': 'EE', 'LastName': ""O'Connor"", 'Affiliation': 'Department of Psychological and Brain Sciences, Boston University, 900 Commonwealth Ave. #2, Boston, MA, 02215, United States.'}, {'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Langer', 'Affiliation': 'Department of Psychological and Brain Sciences, Boston University, 900 Commonwealth Ave. #2, Boston, MA, 02215, United States.'}, {'ForeName': 'Jonathan S', 'Initials': 'JS', 'LastName': 'Comer', 'Affiliation': 'Department of Psychology, Florida International University, 11200 SW 8th Street, Miami, FL, 33199, United States.'}, {'ForeName': 'Martha C', 'Initials': 'MC', 'LastName': 'Tompson', 'Affiliation': 'Department of Psychological and Brain Sciences, Boston University, 900 Commonwealth Ave. #2, Boston, MA, 02215, United States.'}]",Journal of anxiety disorders,['10.1016/j.janxdis.2020.102260'] 2618,32604068,"Changes in Strength, Mobility, and Body Composition Following Self-Selected Exercise in Older Adults.","The purpose of this trial was to examine the effects of self-selected exercise intensities plus either whey protein or placebo supplementation on vital signs, body composition, bone mineral density, muscle strength, and mobility in older adults. A total of 101 participants aged 55 years and older (males [n = 34] and females [n = 67]) were evaluated before and after 12 weeks of self-selected, free-weight resistance exercise plus 30 min of self-paced walking three times per week. The participants were randomized into two groups: whey protein (n = 46) or placebo (n = 55). Three-way mixed factorial analyses of variance were used to test for mean differences for each variable. The 12 weeks of self-selected, self-paced exercise intensities improved resting heart rate, fat-free mass, percent body fat, handgrip strength, bench press strength, leg press strength, and all mobility measurements (p < .05) in males and females despite supplementation status. This suggests that additional protein in well-fed healthy older adults does not enhance the benefit of exercise.",2020,"The 12 weeks of self-selected, self-paced exercise intensities improved resting heart rate, fat-free mass, percent body fat, handgrip strength, bench press strength, leg press strength, and all mobility measurements (p < .05) in males and females despite supplementation status.","['101 participants aged 55 years and older (males [n = 34] and females [n = 67', 'Older Adults', 'older adults', 'fed healthy older adults']","['free-weight resistance exercise plus 30 min of self-paced walking three times per week', 'whey protein', 'self-selected exercise intensities plus either whey protein or placebo supplementation', 'placebo']","['vital signs, body composition, bone mineral density, muscle strength, and mobility', 'Strength, Mobility, and Body Composition', 'resting heart rate, fat-free mass, percent body fat, handgrip strength, bench press strength, leg press strength, and all mobility measurements']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0204695', 'cui_str': 'Feeding patient'}]","[{'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0162535', 'cui_str': 'Electrical Resistance'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0287990', 'cui_str': 'Furin'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0078479', 'cui_str': 'Whey Proteins'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C1821417', 'cui_str': 'Resting heart rate'}, {'cui': 'C0424679', 'cui_str': 'Fat-free mass'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0454326', 'cui_str': 'Bench press'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}]",101.0,0.0477965,"The 12 weeks of self-selected, self-paced exercise intensities improved resting heart rate, fat-free mass, percent body fat, handgrip strength, bench press strength, leg press strength, and all mobility measurements (p < .05) in males and females despite supplementation status.","[{'ForeName': 'Ashley A', 'Initials': 'AA', 'LastName': 'Herda', 'Affiliation': ''}, {'ForeName': 'Brianna D', 'Initials': 'BD', 'LastName': 'McKay', 'Affiliation': ''}, {'ForeName': 'Trent J', 'Initials': 'TJ', 'LastName': 'Herda', 'Affiliation': ''}, {'ForeName': 'Pablo B', 'Initials': 'PB', 'LastName': 'Costa', 'Affiliation': ''}, {'ForeName': 'Jeffrey R', 'Initials': 'JR', 'LastName': 'Stout', 'Affiliation': ''}, {'ForeName': 'Joel T', 'Initials': 'JT', 'LastName': 'Cramer', 'Affiliation': ''}]",Journal of aging and physical activity,['10.1123/japa.2019-0468'] 2619,32604071,Improving Utilization of Maximal Oxygen Uptake and Work Economy in Recreational Cross-Country Skiers With High-Intensity Double-Poling Intervals.,"PURPOSE To investigate the effect of a double-poling (DP) high-intensity aerobic interval-training (HIT) intervention performed without increasing total HIT volume. This means that regular HIT training (eg, running) was replaced by HIT DP. The aim was to explore whether this intervention could improve peak oxygen uptake in DP, the fractional utilization of maximal oxygen uptake (VO2max) in DP, oxygen cost of DP, maximal aerobic speed, and a 3-km DP time trial. METHODS Nine non-specially-DP-trained cross-country skiers (intervention group) and 9 national-level cross-country skiers (control group) were recruited. All participants were tested for VO2max in running, peak oxygen uptake in DP, oxygen cost of DP, and time-trial performance before and after a 6-wk, 3-times-per-week HIT DP intervention. The intervention group omitted all regular HIT with HIT in DP, leaving the total weekly amount of HIT unchanged. RESULTS Seven participants in each group completed the study. VO2max in running remained unchanged in both groups, whereas peak oxygen uptake in DP improved by 7.1% (P = .005) in the intervention group. The fractional utilization of VO2max in DP thus increased by 7.3% (P = .019), oxygen cost of DP by 9.2% (P = .047), maximal aerobic speed by 16.5% (P = .009), and time trial by 19.5% (P = .004) in the intervention group but remained unchanged in the control group. CONCLUSIONS The results indicate that a 6-wk HIT DP intervention could be an effective model to improve DP-specific capacities, with maintenance of VO2max in running.",2020,"The fractional utilization of VO2max in DP thus increased by 7.3% (P = .019), oxygen cost of DP by 9.2% (P = .047), maximal aerobic speed by 16.5% (P = .009), and time trial by 19.5% (P = .004) in the intervention group but remained unchanged in the control group. ","['Recreational Cross-Country', 'Nine non-specially-DP-trained cross-country skiers (intervention group) and 9 national-level cross-country skiers (control group) were recruited']","['double-poling (DP) high-intensity aerobic interval-training (HIT) intervention', 'HIT DP intervention', 'regular HIT training', 'regular HIT with HIT in DP, leaving the total weekly amount of HIT unchanged']","['total HIT volume', 'oxygen cost of DP', 'maximal aerobic speed', 'peak oxygen uptake in DP, the fractional utilization of maximal oxygen uptake (VO2max) in DP, oxygen cost of DP, maximal aerobic speed, and a 3-km DP time trial', 'VO2max in running, peak oxygen uptake in DP, oxygen cost of DP, and time-trial performance', 'fractional utilization of VO2max in DP', 'DP-specific capacities', 'peak oxygen uptake in DP']","[{'cui': 'C0205203', 'cui_str': 'Crossed'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0425040', 'cui_str': 'Skier'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0442739', 'cui_str': 'No status change'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0337815', 'cui_str': 'Poles'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0205369', 'cui_str': 'Specific'}]",9.0,0.0316558,"The fractional utilization of VO2max in DP thus increased by 7.3% (P = .019), oxygen cost of DP by 9.2% (P = .047), maximal aerobic speed by 16.5% (P = .009), and time trial by 19.5% (P = .004) in the intervention group but remained unchanged in the control group. ","[{'ForeName': 'Jan-Michael', 'Initials': 'JM', 'LastName': 'Johansen', 'Affiliation': ''}, {'ForeName': 'Sondre', 'Initials': 'S', 'LastName': 'Eriksen', 'Affiliation': ''}, {'ForeName': 'Arnstein', 'Initials': 'A', 'LastName': 'Sunde', 'Affiliation': ''}, {'ForeName': 'Øystein B', 'Initials': 'ØB', 'LastName': 'Slettemeås', 'Affiliation': ''}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Helgerud', 'Affiliation': ''}, {'ForeName': 'Øyvind', 'Initials': 'Ø', 'LastName': 'Støren', 'Affiliation': ''}]",International journal of sports physiology and performance,['10.1123/ijspp.2019-0689'] 2620,32604072,Functional Threshold Power: Relationship With Respiratory Compensation Point and Effects of Various Warm-Up Protocols.,"PURPOSE The functional threshold power (FTP), which demarcates the transition from steady state to non-steady-state oxidative metabolism, is usually determined with a 20-minute cycling time trial that follows a standard ∼45-minute warm-up. This study aimed to determine if the standard warm-up inherent to FTP determination is actually necessary and how its modification or removal affects the relationship between FTP and the respiratory compensation point (RCP). METHODS A total of 15 male cyclists (age 35 [9] y, maximum oxygen uptake 66.4 [6.8] mL·kg-1·min-1) participated in this randomized, crossover study. Participants performed a ramp test for determination of RCP and maximum oxygen uptake. During subsequent visits, they performed a 20-minute time trial preceded by the ""standard"" warm-up that is typically performed before an FTP test (S-WU), a 10-minute warm-up at the power output (PO) corresponding to 60% of maximum oxygen uptake (60%-WU), or no warm-up (No-WU). FTP was computed as 95% of the mean PO attained during the time trial. RESULTS Although the FTP was correlated with the RCP independently of the warm-up (r = .89, .93, and .86 for No-WU, 60%-WU, and S-WU, respectively; all Ps < .001), the PO at RCP was higher than the FTP in all cases (bias ± 95% limits of agreement = 57 [24], 60 [23], and 57 [32] W for No-WU, 60%-WU, and S-WU, respectively; all Ps < .001 and effect size > 1.70). CONCLUSIONS The FTP is highly correlated with the RCP but corresponds to a significantly lower PO, being these results independent of the warm-up performed (or even with no warm-up).",2020,"; all Ps < .001), the PO at RCP was higher than the FTP in all cases (bias ± 95% limits of agreement = 57 [24], 60 [23], and 57 [32] W for No-WU, 60%-WU, and S-WU, respectively; all Ps < .001 and effect size > 1.70). ","['15 male cyclists (age 35 [9] y, maximum oxygen uptake 66.4 [6.8] mL·kg-1·min-1']","['maximum oxygen uptake (60%-WU), or no warm-up (No-WU']",['FTP'],"[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0429693', 'cui_str': 'Maximum oxygen uptake'}]","[{'cui': 'C0429693', 'cui_str': 'Maximum oxygen uptake'}, {'cui': 'C2350169', 'cui_str': 'Warming-Up Exercise'}]","[{'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0234200', 'cui_str': 'Threshold perception'}]",15.0,0.0360805,"; all Ps < .001), the PO at RCP was higher than the FTP in all cases (bias ± 95% limits of agreement = 57 [24], 60 [23], and 57 [32] W for No-WU, 60%-WU, and S-WU, respectively; all Ps < .001 and effect size > 1.70). ","[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Barranco-Gil', 'Affiliation': ''}, {'ForeName': 'Jaime', 'Initials': 'J', 'LastName': 'Gil-Cabrera', 'Affiliation': ''}, {'ForeName': 'Pedro L', 'Initials': 'PL', 'LastName': 'Valenzuela', 'Affiliation': ''}, {'ForeName': 'Lidia B', 'Initials': 'LB', 'LastName': 'Alejo', 'Affiliation': ''}, {'ForeName': 'Almudena', 'Initials': 'A', 'LastName': 'Montalvo-Pérez', 'Affiliation': ''}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Talavera', 'Affiliation': ''}, {'ForeName': 'Susana', 'Initials': 'S', 'LastName': 'Moral-González', 'Affiliation': ''}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Lucia', 'Affiliation': ''}]",International journal of sports physiology and performance,['10.1123/ijspp.2019-0402'] 2621,32604130,Continuous Cloud-Based Early Warning Score Surveillance to Improve the Safety of Acutely Ill Hospitalized Patients.,"INTRODUCTION This study sought to evaluate the impact of changes made to the process of continually screening hospitalized patients for decompensation. METHODS Patients admitted to hospital wards were screened using a cloud-based early warning score (modified National Early Warning Score [mNEWS]). Patient with mNEWS ≥7 triggered a structured response. Outcomes of this quality improvement study during the intervention period from February through August 2018 (1741 patients) were compared with a control population (1,610 patients) during the same months of 2017. RESULTS The intervention group improved the time to the first lactate order within 24 hours of mNEWS ≥7 (p < .001), the primary outcome, compared with the control group. There was no significant improvement in time to intensive care unit (ICU) transfer, ICU length of stay (LOS), or hospital mortality. Among patients with a lactate ordered within 24 hours, there was a 47% reduction of in-hospital mortality (odds ratio 0.53, 95% confidence interval 0.3-0.89, p = .02) and a 4.7 day reduction in hospital LOS (p < .001) for intervention versus control cohorts. CONCLUSIONS Cloud-based electronic surveillance can result in earlier detection of clinical decompensation. This intervention resulted in lower hospital LOS and mortality among patients with early detection of and intervention for clinical decompensation.",2020,This intervention resulted in lower hospital LOS and mortality among patients with early detection of and intervention for clinical decompensation.,"['Acutely Ill Hospitalized Patients', 'patients with early detection of and intervention for clinical decompensation', 'Patients admitted to hospital wards were screened using a cloud-based early warning score (modified National Early Warning Score [mNEWS', 'screening hospitalized patients for decompensation', 'February through August 2018 (1741 patients) were compared with a control population (1,610 patients) during the same months of 2017']","['Cloud-based electronic surveillance', 'Continuous Cloud-Based Early Warning Score Surveillance']","['hospital LOS', 'time to intensive care unit (ICU) transfer, ICU length of stay (LOS), or hospital mortality', 'lower hospital LOS and mortality', 'hospital mortality', 'time to the first lactate order']","[{'cui': 'C0231218', 'cui_str': 'Malaise'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0596473', 'cui_str': 'Early Diagnosis'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0231187', 'cui_str': 'Decompensation'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C5197888', 'cui_str': 'Early Warning Score'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0032662', 'cui_str': 'Population Control'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0220920', 'cui_str': 'surveillance'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0449820', 'cui_str': 'Score'}]","[{'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0085556', 'cui_str': 'Hospital Mortalities'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C4284072', 'cui_str': 'Order document'}]",,0.0469725,This intervention resulted in lower hospital LOS and mortality among patients with early detection of and intervention for clinical decompensation.,"[{'ForeName': 'Christopher K', 'Initials': 'CK', 'LastName': 'Morgan', 'Affiliation': ''}, {'ForeName': 'Amber B', 'Initials': 'AB', 'LastName': 'Amspoker', 'Affiliation': ''}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Howard', 'Affiliation': ''}, {'ForeName': 'Javad', 'Initials': 'J', 'LastName': 'Razjouyan', 'Affiliation': ''}, {'ForeName': 'Muhammad', 'Initials': 'M', 'LastName': 'Siddique', 'Affiliation': ''}, {'ForeName': 'Seanna', 'Initials': 'S', 'LastName': 'DʼAvignon', 'Affiliation': ''}, {'ForeName': 'Tracey', 'Initials': 'T', 'LastName': 'Rosen', 'Affiliation': ''}, {'ForeName': 'James P', 'Initials': 'JP', 'LastName': 'Herlihy', 'Affiliation': ''}, {'ForeName': 'Aanand D', 'Initials': 'AD', 'LastName': 'Naik', 'Affiliation': ''}]",Journal for healthcare quality : official publication of the National Association for Healthcare Quality,['10.1097/JHQ.0000000000000272'] 2622,32604235,"A Prospective, Split-Face, Randomized Study Comparing Picosecond to Q-Switched Nd: YAG Laser for Treatment of Epidermal and Dermal Pigmented Lesions in Asians.","BACKGROUND Whether picosecond lasers outperform Q-switched lasers in treating pigmented lesions has not been clearly evaluated. OBJECTIVE To compare the efficacy and safety of picosecond and Q-switched lasers in treating epidermal and dermal pigmented lesions in Asians. METHODS Eight subjects with lentigines and 6 subjects with acquired bilateral nevus of Ota-like macules were enrolled. Subjects was randomly treated with a picosecond laser on one side of the face and a Q-switched laser on the other side. Subjective assessments on pigment clearance, and adverse effect were obtained at Weeks 0, 4, 12, and 24 after the final treatment. RESULTS Clinical improvement differed between the 2 laser systems at Week 4 (p = .034), Week 12 (p = .039), and Week 24 (p = .027), with 85.7% of picosecond and 57.2% of Q-switched laser sites showing >50% improvement at 6 months. There was no significant difference in the incidence of side effect and healing time, but picosecond laser was significantly associated with a lower treatment discomfort (p = .05). CONCLUSION The picosecond laser seems to be more effective and better tolerated than Q-switched laser for the treatment of pigmented lesions in Asians.",2020,"RESULTS Clinical improvement differed between the 2 laser systems at Week 4 (p = .034), Week 12 (p = .039), and Week 24 (p = .027), with 85.7% of picosecond and 57.2% of Q-switched laser sites showing >50% improvement at 6 months.","['Eight subjects with lentigines and 6 subjects with acquired bilateral nevus of Ota-like macules were enrolled', 'Epidermal and Dermal Pigmented Lesions in Asians', 'treating epidermal and dermal pigmented lesions in Asians']","['picosecond laser on one side of the face and a Q-switched laser on the other side', 'picosecond and Q-switched lasers', 'Picosecond to Q-Switched Nd: YAG Laser']","['incidence of side effect and healing time', 'efficacy and safety', 'Subjective assessments on pigment clearance, and adverse effect']","[{'cui': 'C0023321', 'cui_str': 'Lentigo'}, {'cui': 'C0439661', 'cui_str': 'Acquired'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0027961', 'cui_str': 'Oculocutaneous melanocytic nevus'}, {'cui': 'C0332573', 'cui_str': 'Macule'}, {'cui': 'C0014520', 'cui_str': 'Epidermis structure'}, {'cui': 'C1522447', 'cui_str': 'Cutaneous route'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0078988', 'cui_str': 'Oriental'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}]","[{'cui': 'C1532556', 'cui_str': 'Picosecond pulsed laser device'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C1956123', 'cui_str': 'Q-Switched Lasers'}, {'cui': 'C0392276', 'cui_str': 'Neodymium-YAG laser'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031911', 'cui_str': 'Pigmentation'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}]",8.0,0.017196,"RESULTS Clinical improvement differed between the 2 laser systems at Week 4 (p = .034), Week 12 (p = .039), and Week 24 (p = .027), with 85.7% of picosecond and 57.2% of Q-switched laser sites showing >50% improvement at 6 months.","[{'ForeName': 'Chanida', 'Initials': 'C', 'LastName': 'Ungaksornpairote', 'Affiliation': '*All authors are affiliated with the Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Woraphong', 'Initials': 'W', 'LastName': 'Manuskiatti', 'Affiliation': ''}, {'ForeName': 'Natchaya', 'Initials': 'N', 'LastName': 'Junsuwan', 'Affiliation': ''}, {'ForeName': 'Rungsima', 'Initials': 'R', 'LastName': 'Wanitphakdeedecha', 'Affiliation': 'All authors are affiliated with the Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.'}]",Dermatologic surgery : official publication for American Society for Dermatologic Surgery [et al.],['10.1097/DSS.0000000000002486'] 2623,32604254,Effects of Hatha Yoga on Cardiac Hemodynamic Parameters and Physical Capacity in Cardiac Rehabilitation Patients.,"PURPOSE The purpose of the present study was to assess the effect of hatha yoga training that was added to the standard cardiac rehabilitation (CR) program on the cardiac hemodynamic parameters and physical capacity of patients with ST-elevation myocardial infarction (STEMI). METHODS The study included 70 male patients aged 45-65 yr with STEMI who were treated by angioplasty. Patients were randomized to standard CR (control group) versus standard CR plus hatha yoga (experimental group). The training program lasted for a total of 24 d for each patient, with day 1 and day 24 used for medical examinations (electrocardiogram, spiroergometric submaximal treadmill test, and echocardiography). The remaining 22 d consisted of the actual training. RESULTS After the CR program the spiroergometric stress test parameters and left ventricular ejection fraction (LVEF) improved in both the experimental and control groups. The most notable changes in echocardiography parameters and physical capacity were in the experimental group. The results showed significant main effect over time, a time-versus-group interaction in LVEF, the duration of the test, and peak oxygen uptake, and a time-versus-group interaction in metabolic equivalents (METs). We also noted the improvement of left ventricular end-diastolic diameter, left ventricular end-systolic diameter, and heart rate over time. CONCLUSION The results revealed better effectiveness in the CR program with a modified hatha yoga training program. Hatha yoga training could be recommended as an adjunct to standard CR.",2020,After the CR program the spiroergometric stress test parameters and left ventricular ejection fraction (LVEF) improved in both the experimental and control groups.,"['70 male patients aged 45-65 yr with STEMI who were treated by', 'Cardiac Rehabilitation Patients', 'patients with ST-elevation myocardial infarction (STEMI']","['medical examinations (electrocardiogram, spiroergometric submaximal treadmill test, and echocardiography', 'Hatha Yoga', 'Hatha yoga training', 'angioplasty', 'standard cardiac rehabilitation (CR) program', 'standard CR (control group) versus standard CR plus hatha yoga', 'hatha yoga training']","['LVEF, the duration of the test, and peak oxygen uptake, and a time-versus-group interaction in metabolic equivalents (METs', 'cardiac hemodynamic parameters and physical capacity', 'spiroergometric stress test parameters and left ventricular ejection fraction (LVEF', 'left ventricular end-diastolic diameter, left ventricular end-systolic diameter, and heart rate over time', 'Cardiac Hemodynamic Parameters and Physical Capacity', 'echocardiography parameters and physical capacity']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C1303258', 'cui_str': 'Acute ST segment elevation myocardial infarction'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0150497', 'cui_str': 'Cardiac rehabilitation'}]","[{'cui': 'C0582103', 'cui_str': 'Medical assessment'}, {'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0087110', 'cui_str': 'Treadmill Test'}, {'cui': 'C0013516', 'cui_str': 'Echocardiography'}, {'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0162577', 'cui_str': 'Angioplasty of blood vessel'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0150497', 'cui_str': 'Cardiac rehabilitation'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C2355577', 'cui_str': 'Metabolic Equivalent'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0012000', 'cui_str': 'Diastole'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0013516', 'cui_str': 'Echocardiography'}]",70.0,0.0168886,After the CR program the spiroergometric stress test parameters and left ventricular ejection fraction (LVEF) improved in both the experimental and control groups.,"[{'ForeName': 'Małgorzata', 'Initials': 'M', 'LastName': 'Grabara', 'Affiliation': 'Department of Physiotherapy in Internal Medicine, Jerzy Kukuczka Academy of Physical Education, Katowice, Poland.'}, {'ForeName': 'Zbigniew', 'Initials': 'Z', 'LastName': 'Nowak', 'Affiliation': ''}, {'ForeName': 'Agata', 'Initials': 'A', 'LastName': 'Nowak', 'Affiliation': ''}]",Journal of cardiopulmonary rehabilitation and prevention,['10.1097/HCR.0000000000000503'] 2624,32604255,Interval Versus Continuous Aerobic Exercise Training in Overweight and Obese Patients With Chronic Obstructive Pulmonary Disease: A RANDOMIZED CONTROLLED STUDY.,"PURPOSE The aim of this study was to compare the efficacy of the supervised pulmonary rehabilitation programs consisting of either an interval or continuous aerobic exercise program, with a home-based exercise program in patients with chronic obstructive pulmonary disease (COPD) who were overweight or obese. METHODS In this randomized controlled study, 72 overweight and obese patients diagnosed as having COPD were randomly assigned to 3 groups. Group 1 received an interval-type (IT) aerobic exercise program, group 2 received a continuous-type (CT) aerobic exercise program (both groups performed home exercises as well) and group 3 was only given a home-based exercise (HE) program. For the evaluation of patients, anthropometric measures, cardiopulmonary exercise testing (CPX), 6-min walk test (6MWT), modified-Borg dyspnea and leg fatigue scores, St George's Respiratory Questionnaire, and Hospital Anxiety and Depression Scale were used. RESULTS Both IT and CT groups showed significant improvement on CPX parameters, 6MWT distances, mental health, and health-related quality of life (HRQoL) compared with the HE group in overweight and obese patients with COPD (P < .001). Moreover, the IT group demonstrated a significant decrease in the modified-Borg dyspnea and leg fatigue during the CPX compared with both CT and HE groups (P < .001). Furthermore, the Borg dyspnea and leg fatigue during training were lower in the IT group than in the CT group (P < .05). CONCLUSIONS An interval or continuous aerobic exercise program added onto a home-based exercise program improved exercise capacity and HRQoL, and reduced anxiety and depression levels in overweight and obese patients with COPD.",2020,"Both IT and CT groups showed significant improvement on CPX parameters, 6MWT distances, mental health, and health-related quality of life (HRQoL) compared with the HE group in overweight and obese patients with COPD (P < .001).","['72 overweight and obese patients diagnosed as having COPD', 'overweight and obese patients with COPD', 'Overweight and Obese Patients With Chronic Obstructive Pulmonary Disease', 'patients with chronic obstructive pulmonary disease (COPD) who were overweight or obese']","['Interval Versus Continuous Aerobic Exercise Training', 'interval-type (IT) aerobic exercise program, group 2 received a continuous-type (CT) aerobic exercise program (both groups performed home exercises as well) and group 3 was only given a home-based exercise (HE) program', 'supervised pulmonary rehabilitation programs consisting of either an interval or continuous aerobic exercise program, with a home-based exercise program', 'continuous aerobic exercise program added onto a home-based exercise program']","[""anthropometric measures, cardiopulmonary exercise testing (CPX), 6-min walk test (6MWT), modified-Borg dyspnea and leg fatigue scores, St George's Respiratory Questionnaire, and Hospital Anxiety and Depression Scale"", 'Borg dyspnea and leg fatigue', 'CPX parameters, 6MWT distances, mental health, and health-related quality of life (HRQoL', 'exercise capacity and HRQoL, and reduced anxiety and depression levels', 'modified-Borg dyspnea and leg fatigue']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}]","[{'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0001701', 'cui_str': 'Aerobic exercises'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0199529', 'cui_str': 'Pulmonary rehabilitation'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}]","[{'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C2959886', 'cui_str': 'Cardiopulmonary exercise test'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C3539657', 'cui_str': 'Hospital anxiety and depression scale'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0150135', 'cui_str': 'Alleviating anxiety'}, {'cui': 'C1319226', 'cui_str': 'Level of depression'}]",72.0,0.0502099,"Both IT and CT groups showed significant improvement on CPX parameters, 6MWT distances, mental health, and health-related quality of life (HRQoL) compared with the HE group in overweight and obese patients with COPD (P < .001).","[{'ForeName': 'Dilek Ozge Zincir', 'Initials': 'DOZ', 'LastName': 'Ercin', 'Affiliation': 'Departments of Physical Medicine and Rehabilitation (Drs Zincir Ercin, Alkan, Findikoglu, and Ardic) and Chest Diseases (Drs Dursunoglu and Evyapan), Faculty of Medicine, Pamukkale University Denizli, Turkey.'}, {'ForeName': 'Hakan', 'Initials': 'H', 'LastName': 'Alkan', 'Affiliation': ''}, {'ForeName': 'Gulin', 'Initials': 'G', 'LastName': 'Findikoglu', 'Affiliation': ''}, {'ForeName': 'Nese', 'Initials': 'N', 'LastName': 'Dursunoglu', 'Affiliation': ''}, {'ForeName': 'Fatma', 'Initials': 'F', 'LastName': 'Evyapan', 'Affiliation': ''}, {'ForeName': 'Fusun', 'Initials': 'F', 'LastName': 'Ardic', 'Affiliation': ''}]",Journal of cardiopulmonary rehabilitation and prevention,['10.1097/HCR.0000000000000519'] 2625,32604256,Reduced Fine Particulate Matter Air Pollution Exposures Using In-Home Portable Air Cleaners: PILOT RESULTS OF THE CARDIAC REHABILITATION AIR FILTER TRIAL (CRAFT).,"PURPOSE Fine particulate matter (PM2.5) air pollution is a leading risk factor for cardiovascular disease. Even low levels common to millions of Americans pose health risks. However, no study has tested protective measures such as in-home portable air cleaners (PACs) among at-risk cardiac patients. We conducted a pilot phase of the Cardiac Rehabilitation Air Filter Trial (CRAFT)-a randomized, double-blind, crossover study of outpatient cardiac rehabilitation patients at Michigan Medicine. METHODS During a routine visit, patients were provided with 2 PACs to run continuously for 5 d in both the bedroom and the main living space. PACs were randomized as active (with HEPA filter) versus sham. On day 4, subjects wore a personal PM2.5 monitor for 24-hr without activity restrictions. After a 1-wk washout, patients crossed over to the opposite mode. RESULTS Patients (n = 20; 4 women) were elderly (70.8 ± 9.6 yr) nonsmokers with cardiovascular disease living near the facility (10.7 ± 6.0 mi). Compared with sham, active in-home PAC use significantly lowered personal-level 24-hr PM2.5 exposures by 43.8% (-12.2 μg·m; 95% CI, -24.2 to -0.2). Sensitivity analyses corroborated the reductions in most patients. CONCLUSION An inexpensive in-home PAC can effectively lower personal PM2.5 exposures in cardiac patients. These benefits occurred even in a region with overall good air quality and if maintained over the long-term could translate into major reductions in cardiovascular events.",2020,"Compared with sham, active in-home PAC use significantly lowered personal-level 24-hr PM2.5 exposures by 43.8% (-12.2 μg·m; 95% CI, -24.2 to -0.2).","['Patients (n = 20; 4 women) were elderly (70.8 ± 9.6 yr) nonsmokers with cardiovascular disease living near the facility (10.7 ± 6.0 mi', 'Home Portable Air Cleaners', 'outpatient cardiac rehabilitation patients at Michigan Medicine', 'cardiac patients']",[],"['personal-level 24-hr PM2.5 exposures', 'Reduced Fine Particulate Matter Air Pollution Exposures', 'cardiovascular events']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0337672', 'cui_str': 'Non-smoker'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0475806', 'cui_str': '1/3 meter'}, {'cui': 'C5191365', 'cui_str': '10.7'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0789995', 'cui_str': 'Air cleaner'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0150497', 'cui_str': 'Cardiac rehabilitation'}, {'cui': 'C0025939', 'cui_str': 'Michigan'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}]",[],"[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0205232', 'cui_str': 'Fine'}, {'cui': 'C1720884', 'cui_str': 'Particulate Matter'}, {'cui': 'C0001873', 'cui_str': 'Air pollution'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}]",,0.140105,"Compared with sham, active in-home PAC use significantly lowered personal-level 24-hr PM2.5 exposures by 43.8% (-12.2 μg·m; 95% CI, -24.2 to -0.2).","[{'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Bard', 'Affiliation': 'Division of Cardiovascular Medicine, Michigan Medicine, Ann Arbor (Messrs Bard and Bryant, Drs Rubenfire and Brook, and Ms Fink); Department of Biostatistics, School of Public Health, University of Michigan, Ann Arbor (Dr Wang and Mss Speth and Zhou); and Department of Family Medicine, College of Human Medicine, Michigan State University, East Lansing (Dr Morishita).'}, {'ForeName': 'Melvyn', 'Initials': 'M', 'LastName': 'Rubenfire', 'Affiliation': ''}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Fink', 'Affiliation': ''}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Bryant', 'Affiliation': ''}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': ''}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Speth', 'Affiliation': ''}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Zhou', 'Affiliation': ''}, {'ForeName': 'Masako', 'Initials': 'M', 'LastName': 'Morishita', 'Affiliation': ''}, {'ForeName': 'Robert D', 'Initials': 'RD', 'LastName': 'Brook', 'Affiliation': ''}]",Journal of cardiopulmonary rehabilitation and prevention,['10.1097/HCR.0000000000000516'] 2626,32614264,"Narrative-Informed Emotion-Focused Psychotherapy in Synchronous, Online Chat Groups for Adolescents and Young Adults with Cancer: A Proof-of-Concept Study.","Few, scalable, evidence-based psychosocial interventions exist for adolescent and young adult cancer survivors (AYAs, 18-39 years old). Using an existing, facilitated, online synchronous chat group-plus-education model (OSG+E), we replaced their educational workbook with an AYA-created film to stimulate an age-specific, emotion-focused group discussion (OSG+V). This randomized proof-of-concept trial compared the two models' content suitability, group processes, and feasibility over 9 months in 34 male and female AYAs with a range of cancers. AYAs rated the OSG + V model more suitable, cohesive, and as having higher levels of important group processes than the OSG+E. A larger randomized trial is feasible for this AYA-appropriate, emotion-focused OSG + V model.",2020,"AYAs rated the OSG + V model more suitable, cohesive, and as having higher levels of important group processes than the OSG+E. A larger randomized trial is feasible for this AYA-appropriate, emotion-focused OSG + V model.","['adolescent and young adult cancer survivors (AYAs, 18-39 years old', 'Adolescents and Young Adults with Cancer', '34 male and female AYAs with a range of cancers']","['Narrative-Informed Emotion-Focused Psychotherapy', 'online synchronous chat group-plus-education model (OSG+E), we replaced their educational workbook with an AYA-created film to stimulate an age-specific, emotion-focused group discussion (OSG+V']",[],"[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}]","[{'cui': 'C1135957', 'cui_str': 'Narration'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0033968', 'cui_str': 'Psychotherapy'}, {'cui': 'C0439580', 'cui_str': 'Synchronous'}, {'cui': 'C0124604', 'cui_str': 'Catha edulis'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C1704608', 'cui_str': 'Film'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0016400', 'cui_str': 'Focus Groups'}, {'cui': 'C0557061', 'cui_str': 'Discussion'}]",[],34.0,0.0670882,"AYAs rated the OSG + V model more suitable, cohesive, and as having higher levels of important group processes than the OSG+E. A larger randomized trial is feasible for this AYA-appropriate, emotion-focused OSG + V model.","[{'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Lang', 'Affiliation': 'Faculty of Nursing and Department of Community Health Sciences, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Joseph C', 'Initials': 'JC', 'LastName': 'Dort', 'Affiliation': 'Departments of Surgery, Oncology, and Community Health Sciences, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Stephen', 'Affiliation': 'Department of Psychosocial Oncology, Tom Baker Cancer Centre, Alberta Health Services, Calgary, Alberta, Canada.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Lamont', 'Affiliation': 'Department of Psychosocial Oncology, Tom Baker Cancer Centre, Alberta Health Services, Calgary, Alberta, Canada.'}, {'ForeName': 'Janine', 'Initials': 'J', 'LastName': 'Giese-Davis', 'Affiliation': 'Division of Psychosocial Oncology, Department of Oncology, Cumming School of Medicine, and Department of Psychology, University of Calgary, Calgary, Alberta, Canada.'}]",Journal of adolescent and young adult oncology,['10.1089/jayao.2020.0030'] 2627,32614361,"The Efficacy of a Dietary Supplement with Carnosine and Hibiscus Sabdariffa L. (AqualiefTM) in Patients with Xerostomia: a Randomized, Placebo-Controlled, Double-Blind Trial.","The purpose of this study was to test the safety and efficacy of AqualiefTM in patients affected by xerostomia. The main ingredients of AqualiefTM are carnosine and dried calyces of Hibiscus sabdariffa L. (karkadè) for their buffering effect at pH 7 as well as for their antioxidant, antimicrobial and lenitive properties. In a Randomized, Placebo-Controlled, Double-Blind Trial, sixty patients with xerostomia (RTOG/EORTC grade 1-2) were randomly assigned to receive either placebo, or AqualiefTM tablets (three times/day after meals) for 6 consecutive days. A questionnaire was used to evaluate dry mouth symptoms before and after 6 days of AqualiefTM or placebo application. Unstimulated and stimulated salivary flow rates and pH were measured before and after application. Treatment with AqualiefTM for 6 days induced a significant increase in saliva pH from 6.2 ± 0.5 to 6.4 ± 0.6 (P < 0.05) while placebo was ineffective (from 6.2 ± 0.5 to 6.3 ± 0.5). AqualiefTM also induced a significant increase in the pH of stimulated saliva from 6.3 ± 0.5 to 6.6 ± 0.5 (P < 0.01). Placebo was ineffective also in this setting (from 6.2 ± 0.5 to 6.3 ± 0.5). Besides an expected normalization of the saliva pH value, AqualiefTM treatment for 6 days greatly increased (56%, P < 0.0001) saliva production. Placebo induced a 19% increase (P < 0.05), which was likely due to mechanical stimulation. AqualiefTM also increased stimulated saliva production (27% increase with respect to day 0, P < 0.05), while placebo was ineffective. AqualiefTM was effective in regulating the saliva pH, in increasing saliva production and improving dry mouth symptoms in xerostomic patients.",2020,"AqualiefTM was effective in regulating the saliva pH, in increasing saliva production and improving dry mouth symptoms in xerostomic patients.","['Patients with Xerostomia', 'patients affected by xerostomia', 'xerostomic patients', 'sixty patients with xerostomia (RTOG/EORTC grade 1-2']","['placebo, or AqualiefTM tablets', 'Placebo', 'Dietary Supplement with Carnosine and Hibiscus Sabdariffa L. (AqualiefTM', 'placebo']","['safety and efficacy of AqualiefTM', 'stimulated saliva production', 'saliva pH value', 'saliva pH', 'saliva production and improving dry mouth symptoms']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043352', 'cui_str': 'Xerostomia'}, {'cui': 'C0522476', 'cui_str': 'Patient affected'}, {'cui': 'C0475269', 'cui_str': 'G1 grade'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0007267', 'cui_str': 'Carnosine'}, {'cui': 'C1207898', 'cui_str': 'Roselle'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036087', 'cui_str': 'Saliva'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0043352', 'cui_str': 'Xerostomia'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",60.0,0.435261,"AqualiefTM was effective in regulating the saliva pH, in increasing saliva production and improving dry mouth symptoms in xerostomic patients.","[{'ForeName': 'L', 'Initials': 'L', 'LastName': 'Levrini', 'Affiliation': 'Department of Surgical and Morphological Sciences, Dental Hygiene School, University of Insubria, Varese.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Azzi', 'Affiliation': 'Department of Surgical and Morphological Sciences, Dental Hygiene School, University of Insubria, Varese.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Bossi', 'Affiliation': 'Private pratice.'}]",La Clinica terapeutica,['10.7417/CT.2020.2231'] 2628,32614368,Awake fiberoptic intubation in patients with stenosis of the upper airways: Utility of the laryngeal nerve block.,"Awake fiberoptic intubation (AFOI) is mandatory to manage difficult airways. Superior laryngeal nerve block (SLNB) could reduce risks and improve patient comfort. The aim of this study is to assess the procedural comfort of SLNB during AFOI in a population of patients undergoing upper airway oncological surgery. Forty patients were randomized into two groups and were treated with continuous infusion of remifentanil, topic anesthesia and intercricoid block. In the study group (=20), SLNB was performed with lidocaine (L-SLNB); in the control group (n=20) SLNB was performed using saline (S-SLNB). AFOI was more comfortable in the L-SLNB group compared to S-SLNB patients [FOICS ≤ 1 in 18 patients (90%) L-SLNB; 2 (10%) S-SLNB (P <0.001)]. Intubation was faster in L-SLNB (47.45 ±15.38 sec) than S-SLNB (80.15 ±37.91 sec) (p <0.001). The SLNB procedure during AFOI is a safe and comfortable procedure in a population of patients undergoing upper airways surgery. Time to intubation was shorter in L-SLNB than in S-SLNB.",2020,Intubation was faster in L-SLNB (47.45 ±15.38 sec) than S-SLNB (80.15 ±37.91 sec) (p <0.001).,"['patients undergoing upper airways surgery', 'Forty patients', 'patients with stenosis of the upper airways', 'patients undergoing upper airway oncological surgery']","['Awake fiberoptic intubation', 'lidocaine (L-SLNB', 'Awake fiberoptic intubation (AFOI', 'Superior laryngeal nerve block (SLNB', 'remifentanil, topic anesthesia and intercricoid block', 'SLNB']","['Time to intubation', 'AFOI']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0225377', 'cui_str': 'Structure of upper respiratory tract cavity'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0678234', 'cui_str': 'Form of stenosis'}]","[{'cui': 'C0234422', 'cui_str': 'Awake'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0394817', 'cui_str': 'Local anesthetic superior laryngeal nerve block'}, {'cui': 'C0246631', 'cui_str': 'remifentanil'}, {'cui': 'C1522168', 'cui_str': 'Topical route'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0021925', 'cui_str': 'Intubation'}, {'cui': 'C0234422', 'cui_str': 'Awake'}]",40.0,0.0565902,Intubation was faster in L-SLNB (47.45 ±15.38 sec) than S-SLNB (80.15 ±37.91 sec) (p <0.001).,"[{'ForeName': 'F', 'Initials': 'F', 'LastName': 'Alessandri', 'Affiliation': 'Department of Anesthesia and Critical Care Medicine, University of Rome ""Sapienza"", Policlinico Umberto I, Rome.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Bellucci', 'Affiliation': 'Department of Anesthesia and Critical Care Medicine, University of Rome ""Sapienza"", Policlinico Umberto I, Rome.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Tellan', 'Affiliation': 'Department of Anesthesia and Critical Care Medicine, University of Rome ""Sapienza"", Policlinico Umberto I, Rome.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Pinchera', 'Affiliation': 'Department of Anesthesia and Critical Care Medicine, University of Rome ""Sapienza"", Policlinico Umberto I, Rome.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Buonopane', 'Affiliation': 'Department of Anesthesia and Critical Care Medicine, University of Rome ""Sapienza"", Policlinico Umberto I, Rome.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Ralli', 'Affiliation': 'Department of Sense Organs, University of Rome ""Sapienza"", Policlinico Umberto I, Rome.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Greco', 'Affiliation': 'Department of Sense Organs, University of Rome ""Sapienza"", Policlinico Umberto I, Rome.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'de Vincentiis', 'Affiliation': 'Department of oral and maxillofacial sciences, University of Rome ""Sapienza"", Rome, Italy.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Pugliese', 'Affiliation': 'Department of Anesthesia and Critical Care Medicine, University of Rome ""Sapienza"", Policlinico Umberto I, Rome.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Bilotta', 'Affiliation': 'Department of Anesthesia and Critical Care Medicine, University of Rome ""Sapienza"", Policlinico Umberto I, Rome.'}]",La Clinica terapeutica,['10.7417/CT.2020.2236'] 2629,32614394,External resistance is imperative for training-induced efferent neural drive enhancement in older adults.,"Strength training performed with heavy loads and maximal intended velocity is documented to enhance efferent neural drive to maximally contracting musculature in older adults. However, it remains unclear whether the neural plasticity following training result from motor skill learning or if external resistance is a prerequisite. To investigate this, we assessed electrically evoked potentials (H-reflex and V-waves normalized to maximal M-wave) and voluntary activation (VA) in 36 older adults (73±4 years) randomized to 3 weeks of plantar flexion strength training, with (maximal strength training; MST) or without (unloaded ballistic training; UBT) heavy external loading (90% of one repetition maximum), or a control group. Both training groups aimed to execute the concentric phase of movement as fast and forcefully as possible. The MST group improved maximal voluntary contraction (MVC) and rate of force development (RFD) by 18±13% (p=0.001; Hedges g=0.66) and 35±17% (p<0.001; g=0.94), respectively, and this was different (MVC: p=0.013; RFD: p=0.001) from the UBT group which exhibited a 7±8% (p=0.033; g=0.32) increase in MVC and a tendency to increase RFD (p=0.119; g=0.22). Concomitant improvements in efferent neural drive (Vmax/Msup-ratio: 0.14±0.08 to 0.24±0.20; p=0.010) and a tendency towards increased VA (79±9% to 84±5%; p=0.098), were only apparent after MST. No changes were observed in Hmax/Mmax-ratio for the groups. In conclusion, external loading during exercise training appears to be a prerequisite for efferent neural drive enhancement in older adults. Thus, strength training with heavy loads should be recommended to counteract the typically observed age-related decline in motoneuron firing frequency and recruitment.",2020,"The MST group improved maximal voluntary contraction (MVC) and rate of force development (RFD) by 18±13% (p=0.001; Hedges g=0.66) and 35±17% (p<0.001; g=0.94), respectively, and this was different (MVC: p=0.013; RFD: p=0.001) from the UBT group which exhibited a 7±8% (p=0.033; g=0.32) increase in MVC and a tendency to increase RFD (p=0.119; g=0.22).","['older adults', '36 older adults (73±4 years']","['plantar flexion strength training, with (maximal strength training; MST) or without (unloaded ballistic training; UBT) heavy external loading (90% of one repetition maximum), or a control group', 'electrically evoked potentials (H-reflex and V-waves normalized to maximal M-wave) and voluntary activation (VA', 'MST']","['maximal voluntary contraction (MVC) and rate of force development (RFD', 'MVC and a tendency to increase RFD', 'Hmax/Mmax-ratio', 'efferent neural drive']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0231784', 'cui_str': 'Plantar flexion'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C1834582', 'cui_str': 'Transient abnormal myelopoiesis'}, {'cui': 'C0443149', 'cui_str': 'Ballistic'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0439539', 'cui_str': 'Heavy (weight)'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0013790', 'cui_str': 'Electricity'}, {'cui': 'C1444748', 'cui_str': 'Evoked'}, {'cui': 'C0018447', 'cui_str': 'H-reflex'}, {'cui': 'C4301968', 'cui_str': 'v wave'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}]","[{'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0205116', 'cui_str': 'Efferent'}, {'cui': 'C0004379', 'cui_str': 'Driving'}]",,0.0148618,"The MST group improved maximal voluntary contraction (MVC) and rate of force development (RFD) by 18±13% (p=0.001; Hedges g=0.66) and 35±17% (p<0.001; g=0.94), respectively, and this was different (MVC: p=0.013; RFD: p=0.001) from the UBT group which exhibited a 7±8% (p=0.033; g=0.32) increase in MVC and a tendency to increase RFD (p=0.119; g=0.22).","[{'ForeName': 'Runar', 'Initials': 'R', 'LastName': 'Unhjem', 'Affiliation': 'Faculty of Nursing and Health Sciences, Nord University, Bodø, Norway.'}, {'ForeName': 'Tiril', 'Initials': 'T', 'LastName': 'Tøien', 'Affiliation': 'Department of Health and Social Sciences, Molde University College, Norway.'}, {'ForeName': 'Ann Charlotte Gjertsen', 'Initials': 'ACG', 'LastName': 'Kvellestad', 'Affiliation': 'Department of Circulation and Medical Imaging, Faculty of Medicine and Health Sciences, Norwegian University of Science and Technology, Trondheim, Norway.'}, {'ForeName': 'Thomas Storehaug', 'Initials': 'TS', 'LastName': 'Øren', 'Affiliation': 'Department of Circulation and Medical Imaging, Faculty of Medicine and Health Sciences, Norwegian University of Science and Technology, Trondheim, Norway.'}, {'ForeName': 'Eivind', 'Initials': 'E', 'LastName': 'Wang', 'Affiliation': 'Department of Health and Social Sciences, Molde University College, Norway.'}]","The journals of gerontology. Series A, Biological sciences and medical sciences",['10.1093/gerona/glaa160'] 2630,32609532,Cardiovascular and metabolic responses to passive hypoxic conditioning in overweight and mildly obese individuals.,"BACKGROUND While severe intermittent hypoxia (IH) is well known to induce deleterious cardiometabolic consequences, moderate IH may induce positive effects in obese individuals. The present study aimed to evaluate the effect of two hypoxic conditioning programs on cardiovascular and metabolic health status of overweight or obese individuals. METHODS In this randomized single-blind controlled study, 35 subjects (54±9.3yr, 31.7±3.5kg·m -2 ) were randomized into three 8-week interventions (three 1-hour sessions per week): sustained hypoxia (SH), arterial oxygen saturation (SpO 2 ) =75%; IH, 5min SpO 2 =75% - 3min normoxia; normoxia. Ventilation, heart rate, blood pressure and tissue oxygenation were measured during the first and last hypoxic conditioning sessions. Vascular function, blood glucose and insulin, lipid profile, nitric oxide metabolites and oxidative stress were evaluated before and after the interventions. RESULTS Both SH and IH increased ventilation in hypoxia (+1.8±2.1 and +2.3±3.6l·min -1 , respectively; p<0.05) and reduced normoxic diastolic blood pressure (-12±15 and -13±10mmHg, respectively; p<0.05), while changes in normoxic systolic blood pressure were not significant (+3±9 and -6±13mmHg, respectively; p>0.05). IH only reduced heart rate variability (e.g. root-mean-square difference of successive normal R-R intervals in normoxia -21±35%; p<0.05). Both SH and IH induced no significant change in body mass index, vascular function, blood glucose, insulin and lipid profile, nitric oxide metabolites and oxidative stress, except an increase in superoxide dismutase activity following SH. CONCLUSIONS This study indicates that passive hypoxic conditioning in obese individuals induces some positive cardiovascular and respiratory improvements despite no change in anthropometric data and even a reduction in heart rate variability during IH exposure.",2020,"Both SH and IH induced no significant change in body mass index, vascular function, blood glucose, insulin and lipid profile, nitric oxide metabolites and oxidative stress, except an increase in superoxide dismutase activity following SH. ","['overweight and mildly obese individuals', 'overweight or obese individuals', 'obese individuals', '35 subjects (54±9.3yr, 31.7±3.5kg·m -2 ']","['hypoxic conditioning programs', 'sustained hypoxia (SH), arterial oxygen saturation (SpO 2 ) =75%; IH, 5min SpO 2 =75% - 3min normoxia; normoxia', 'passive hypoxic conditioning']","['Cardiovascular and metabolic responses', 'normoxic systolic blood pressure', 'body mass index, vascular function, blood glucose, insulin and lipid profile, nitric oxide metabolites and oxidative stress', 'Ventilation, heart rate, blood pressure and tissue oxygenation', 'normoxic diastolic blood pressure', 'ventilation in hypoxia', 'cardiovascular and metabolic health status', 'superoxide dismutase activity', 'heart rate variability', 'Vascular function, blood glucose and insulin, lipid profile, nitric oxide metabolites and oxidative stress']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C2945599', 'cui_str': 'Mild'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0428175', 'cui_str': 'Oxygen saturation measurement, arterial'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}]","[{'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0232337', 'cui_str': 'Vascular function'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0018759', 'cui_str': 'Health status'}, {'cui': 'C0038838', 'cui_str': 'Superoxide Dismutase'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}]",35.0,0.0345242,"Both SH and IH induced no significant change in body mass index, vascular function, blood glucose, insulin and lipid profile, nitric oxide metabolites and oxidative stress, except an increase in superoxide dismutase activity following SH. ","[{'ForeName': 'Samarmar', 'Initials': 'S', 'LastName': 'Chacaroun', 'Affiliation': 'HP2 Laboratory, Grenoble Alpes University, France.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Borowik', 'Affiliation': 'HP2 Laboratory, Grenoble Alpes University, France.'}, {'ForeName': 'Stephane', 'Initials': 'S', 'LastName': 'Doutreleau', 'Affiliation': 'HP2 Laboratory, Grenoble Alpes University, INSERM.'}, {'ForeName': 'Elise', 'Initials': 'E', 'LastName': 'Belaidi', 'Affiliation': 'HP2 laboratory, Grenoble Alpes University, France.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Wuyam', 'Affiliation': 'Université Joseph Fourier IFR-1.'}, {'ForeName': 'Renaud', 'Initials': 'R', 'LastName': 'Tamisier', 'Affiliation': 'INSERM U1042, HP2 Laboratory and Sleep Laboratory and EFCR, Pôle Rééducation et Physiologie, University Hospital Grenoble, Grenoble University Hospital, France.'}, {'ForeName': 'Jean-Louis', 'Initials': 'JL', 'LastName': 'Pépin', 'Affiliation': 'HP2 Laboratory, Grenoble Alpes University, France.'}, {'ForeName': 'Patrice', 'Initials': 'P', 'LastName': 'Flore', 'Affiliation': 'Université Joseph Fourier Grenoble I, IFR1.'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Verges', 'Affiliation': 'HP2 Laboratory, Grenoble Alpes University, INSERM, France.'}]","American journal of physiology. Regulatory, integrative and comparative physiology",['10.1152/ajpregu.00311.2019'] 2631,32609534,Efficacy of Goreisan in Preventing Transurethral Resection Syndrome in Transurethral Resection of the Prostate: A Randomized-Controlled Study.,"Objectives: Nonconductive irrigation fluids used during transurethral resection (TUR) of the prostate can cause fluid overload and dilutional hyponatremia. TUR syndrome is generally defined as serum sodium at or below 125 mmol/L with cardiovascular and neurologic symptoms. The aim of this study was to evaluate the effects of Goreisan, a traditional Japanese Kampo medicine, on serum sodium levels and the occurrence of TUR syndrome in patients undergoing TUR of the prostate. Design: This was a randomized-controlled trial. Settings/Location: This trial was conducted at the Osaka Medical College Hospital and Keneikai Sanko Hospital. Subjects: Fifty patients scheduled for TUR of the prostate were included. Interventions: Patients in the Goreisan group ( n  = 23) received 2.5 g Goreisan orally on the night before surgery and on the morning of surgery. The control group ( n  = 27) did not receive Goreisan. Surgical procedures, perioperative management, and patient monitoring were otherwise the same in both groups. Outcome Measures: The primary outcome was occurrence of TUR syndrome. The secondary outcome was serum sodium level. Results: Serum sodium remained above 125 mmol/L in all patients, so none of the patients met the criteria for TUR syndrome. However, the Goreisan group had significantly higher intraoperative sodium levels ( p  < 0.001) and significantly higher intraoperative ( p  = 0.008) and postoperative ( p  = 0.02) hemoglobin levels than the control group. Conclusions: These findings indicate that preoperative Goreisan administration can help maintain serum sodium levels in patients undergoing TUR of the prostate.",2020,"However, the Goreisan group had significantly higher intraoperative sodium levels ( p  < 0.001) and significantly higher intraoperative ( p  = 0.008) and postoperative ( p  = 0.02) hemoglobin levels than the control group. ","['Subjects: Fifty patients scheduled for TUR of the prostate were included', 'Patients in the Goreisan group ( n \u2009=\u200923', 'Transurethral Resection of the Prostate', 'Osaka Medical College Hospital and Keneikai Sanko Hospital', 'patients undergoing TUR of the prostate']","['Nonconductive irrigation fluids used during transurethral resection (TUR', 'Goreisan, a traditional Japanese Kampo medicine', 'Goreisan']","['Serum sodium', 'occurrence of TUR syndrome', 'serum sodium level', 'hemoglobin levels', 'intraoperative sodium levels']","[{'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0041400', 'cui_str': 'Turkey - country'}, {'cui': 'C0033572', 'cui_str': 'Prostatic'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0040771', 'cui_str': 'Transurethral prostatectomy'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0593225', 'cui_str': 'Solution for irrigation'}, {'cui': 'C0205497', 'cui_str': 'Transurethral approach'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0041400', 'cui_str': 'Turkey - country'}, {'cui': 'C0443324', 'cui_str': 'Traditional'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}, {'cui': 'C0752221', 'cui_str': 'Kampo Medicine'}]","[{'cui': 'C0523891', 'cui_str': 'Sodium measurement, serum'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0349610', 'cui_str': 'TUR syndrome'}, {'cui': 'C0518015', 'cui_str': 'Haemoglobin'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0337443', 'cui_str': 'Sodium measurement'}]",50.0,0.0297028,"However, the Goreisan group had significantly higher intraoperative sodium levels ( p  < 0.001) and significantly higher intraoperative ( p  = 0.008) and postoperative ( p  = 0.02) hemoglobin levels than the control group. ","[{'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Fujiwara', 'Affiliation': 'Department of Anesthesiology, Osaka Medical College, Osaka, Japan.'}, {'ForeName': 'Junko', 'Initials': 'J', 'LastName': 'Nakahira', 'Affiliation': 'Department of Anesthesiology, Osaka Medical College, Osaka, Japan.'}, {'ForeName': 'Shoko', 'Initials': 'S', 'LastName': 'Nakano', 'Affiliation': 'Department of Anesthesiology, Osaka Medical College, Osaka, Japan.'}, {'ForeName': 'Toshiyuki', 'Initials': 'T', 'LastName': 'Sawai', 'Affiliation': 'Department of Anesthesiology, Osaka Medical College, Osaka, Japan.'}, {'ForeName': 'Toshiaki', 'Initials': 'T', 'LastName': 'Minami', 'Affiliation': 'Department of Anesthesiology, Osaka Medical College, Osaka, Japan.'}]","Journal of alternative and complementary medicine (New York, N.Y.)",['10.1089/acm.2019.0269'] 2632,32609573,"Re: The MRI in Active Surveillance ""MRIAS"" Trial: Use of Baseline mpMRI and Saturation Biopsy to Reduce the Frequency of Surveillance Prostate Biopsies.",,2020,,[],['Baseline mpMRI and Saturation Biopsy'],[],[],"[{'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C3898221', 'cui_str': 'Multiparametric magnetic resonance elastography'}, {'cui': 'C0522534', 'cui_str': 'Saturated'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}]",[],,0.0620028,,"[{'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Montorsi', 'Affiliation': 'Division of Oncology/Unit of Urology, URI, IRCCS Ospedale San Raffaele, Milan, Italy.'}, {'ForeName': 'Giorgio', 'Initials': 'G', 'LastName': 'Gandaglia', 'Affiliation': 'Division of Oncology/Unit of Urology, URI, IRCCS Ospedale San Raffaele, Milan, Italy.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Fossati', 'Affiliation': 'Division of Oncology/Unit of Urology, URI, IRCCS Ospedale San Raffaele, Milan, Italy.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Briganti', 'Affiliation': 'Division of Oncology/Unit of Urology, URI, IRCCS Ospedale San Raffaele, Milan, Italy.'}]",The Journal of urology,['10.1097/JU.0000000000001190'] 2633,32609576,"Evaluation of Patient's Perceptions, Healing, and Reattachment After Conventional and Diode Laser Frenectomy: A Three-Arm Randomized Clinical Trial.","Objective: The aim of this study is to compare the conventional and diode laser techniques in terms of patient's perceptions, epithelization, reattachment, and periodontal clinical parameters in the treatment of abnormal papillary frenum. Materials and methods: Forty-eight patients with abnormal papillary frenum were enrolled in the study. Patients were randomly assigned into three groups; conventional frenectomy operation (C group), diode laser-assisted frenectomy (L group), and diode laser-assisted frenectomy with conventional horizontal incision on the periosteum (L + P group). Post-operative pain, discomfort in speaking, and chewing scores were assessed with visual analogue scale (VAS) at post-operative 3rd hour and on days 1, 7, 14, 21, and 45. Epithelialization process of the wound surface was evaluated by hydrogen peroxide solution applied to the wound on days 7, 14, 21, and 45 following operations. The distance between the frenum attachment point and mucogingival junction (FMGJ) was recorded at baseline, post-operative 45th day, and 6th month to assess the reattachment of the frenum. Plaque index, gingival index, bleeding on probing, and probing depth were recorded at baseline and post-operative 7th, 14th, 21 st , and 45th days. Results: On the 1st and 7th day after operation, VAS pain score in the C group was significantly higher than in the L and L + P groups ( p  < 0.017). Difficulty in speaking and chewing scores were significantly lower in the L and L + P groups compared to the C group at post-operative 3rd hour and 7th day ( p  < 0.017). The FMGJ and epithelization period demonstrated no difference among the groups at any time point ( p  > 0.05). Conclusions: Our results suggest that diode laser provides better post-operative patient's perceptions than the conventional technique in frenectomy operation. In addition, both conventional and laser-assisted frenectomy surgeries prevent the frenum reattachment regardless of periosteal horizontal incision.",2020,Difficulty in speaking and chewing scores were significantly lower in the L and L + P groups compared to the C group at post-operative 3rd hour and 7th day ( p  < 0.017).,"['Forty-eight patients with abnormal papillary frenum were enrolled in the study', 'abnormal papillary frenum']","['conventional frenectomy operation (C group), diode laser-assisted frenectomy (L group), and diode laser-assisted frenectomy with conventional horizontal incision on the periosteum (L\u2009+\u2009P group', 'conventional and laser-assisted frenectomy surgeries', 'Conventional and Diode Laser Frenectomy', 'diode laser', 'conventional and diode laser techniques', 'hydrogen peroxide solution']","['VAS pain score', 'visual analogue scale (VAS', 'Plaque index, gingival index, bleeding on probing, and probing depth', 'mucogingival junction (FMGJ', 'Post-operative pain, discomfort in speaking, and chewing scores', 'Difficulty in speaking and chewing scores', ""Patient's Perceptions, Healing, and Reattachment""]","[{'cui': 'C4319608', 'cui_str': '48'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205161', 'cui_str': 'Abnormal'}, {'cui': 'C0205312', 'cui_str': 'Papillary'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0441837', 'cui_str': 'Group C'}, {'cui': 'C0392254', 'cui_str': 'Semiconductor laser device'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205126', 'cui_str': 'Horizontal'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0031110', 'cui_str': 'Periosteum'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0020281', 'cui_str': 'Hydrogen Peroxide'}, {'cui': 'C0037633', 'cui_str': 'Solution'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0011390', 'cui_str': 'Dental Plaque Indices'}, {'cui': 'C0017569', 'cui_str': 'Gingival Indexes'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0447454', 'cui_str': 'Mucogingival junction'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0024888', 'cui_str': 'Mastication'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0234856', 'cui_str': 'Speaking'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0185042', 'cui_str': 'Reattachment - action'}]",48.0,0.0357075,Difficulty in speaking and chewing scores were significantly lower in the L and L + P groups compared to the C group at post-operative 3rd hour and 7th day ( p  < 0.017).,"[{'ForeName': 'Gamze', 'Initials': 'G', 'LastName': 'Sezgin', 'Affiliation': 'Department of Periodontology, Faculty of Dentistry, Marmara University, Istanbul, Turkey.'}, {'ForeName': 'Hafize', 'Initials': 'H', 'LastName': 'Ozturk Ozener', 'Affiliation': 'Department of Periodontology, Faculty of Dentistry, Marmara University, Istanbul, Turkey.'}, {'ForeName': 'Suleyman Emre', 'Initials': 'SE', 'LastName': 'Meseli', 'Affiliation': 'Department of Periodontology, Faculty of Dentistry, Istanbul Aydin University, Istanbul, Turkey.'}, {'ForeName': 'Leyla', 'Initials': 'L', 'LastName': 'Kuru', 'Affiliation': 'Department of Periodontology, Faculty of Dentistry, Marmara University, Istanbul, Turkey.'}]","Photobiomodulation, photomedicine, and laser surgery",['10.1089/photob.2019.4783'] 2634,32609756,Participation in adherence clubs and on-time drug pickup among HIV-infected adults in Zambia: A matched-pair cluster randomized trial.,"BACKGROUND Current models of HIV service delivery, with frequent facility visits, have led to facility congestion, patient and healthcare provider dissatisfaction, and suboptimal quality of services and retention in care. The Zambian urban adherence club (AC) is a health service innovation designed to improve on-time drug pickup and retention in HIV care through off-hours facility access and pharmacist-led group drug distribution. Similar models of differentiated service delivery (DSD) have shown promise in South Africa, but observational analyses of these models are prone to bias and confounding. We sought to evaluate the effectiveness and implementation of ACs in Zambia using a more rigorous study design. METHODS AND FINDINGS Using a matched-pair cluster randomized study design (ClinicalTrials.gov: NCT02776254), 10 clinics were randomized to intervention (5 clinics) or control (5 clinics). At each clinic, between May 19 and October 27, 2016, a systematic random sample was assessed for eligibility (HIV+, age ≥ 14 years, on ART >6 months, not acutely ill, CD4 count not <200 cells/mm3) and willingness to participate in an AC. Clinical and antiretroviral drug pickup data were obtained through the existing electronic medical record. AC meeting attendance data were collected at intervention facilities prospectively through October 28, 2017. The primary outcome was time to first late drug pickup (>7 days late). Intervention effect was estimated using unadjusted Kaplan-Meier survival curves and a Cox proportional hazards model to derive an adjusted hazard ratio (aHR). Medication possession ratio (MPR) and implementation outcomes (adoption, acceptability, appropriateness, feasibility, and fidelity) were additionally evaluated as secondary outcomes. Baseline characteristics were similar between 571 intervention and 489 control participants with respect to median age (42 versus 41 years), sex (62% versus 66% female), median time since ART initiation (4.8 versus 5.0 years), median CD4 count at study enrollment (506 versus 533 cells/mm3), and baseline retention (53% versus 55% with at least 1 late drug pickup in previous 12 months). The rate of late drug pickup was lower in intervention participants compared to control participants (aHR 0.26, 95% CI 0.15-0.45, p < 0.001). Median MPR was 100% in intervention participants compared to 96% in control participants (p < 0.001). Although 18% (683/3,734) of AC group meeting visits were missed, on-time drug pickup (within 7 days) still occurred in 51% (350/683) of these missed visits through alternate means (use of buddy pickup or early return to the facility). Qualitative evaluation suggests that the intervention was acceptable to both patients and providers. While patients embraced the convenience and patient-centeredness of the model, preference for traditional adherence counseling and need for greater human resources influenced intervention appropriateness and feasibility from the provider perspective. The main limitations of this study were the small number of clusters, lack of viral load data, and relatively short follow-up period. CONCLUSIONS ACs were found to be an effective model of service delivery for reducing late ART drug pickup among HIV-infected adults in Zambia. Drug pickup outside of group meetings was relatively common and underscores the need for DSD models to be flexible and patient-centered if they are to be effective. TRIAL REGISTRATION ClinicalTrials.gov NCT02776254.",2020,Median MPR was 100% in intervention participants compared to 96% in control participants (p < 0.001).,"['At each clinic, between May 19 and October 27, 2016, a systematic random sample was assessed for eligibility (HIV+, age ≥ 14 years, on ART >6 months, not acutely ill, CD4 count not <200 cells/mm3) and willingness to participate in an AC', 'Zambian urban adherence club (AC', '489 control participants with respect to median age (42 versus 41 years), sex (62% versus 66% female', 'HIV-infected adults in Zambia', '10 clinics were randomized to intervention (5 clinics) or control (5 clinics']",['differentiated service delivery (DSD'],"['rate of late drug pickup', 'median time since ART initiation', 'Median MPR', 'unadjusted Kaplan-Meier survival curves', 'time to first late drug pickup', 'median CD4 count', 'Medication possession ratio (MPR) and implementation outcomes (adoption, acceptability, appropriateness, feasibility, and fidelity']","[{'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0013893', 'cui_str': 'Eligibility Determination'}, {'cui': 'C0019699', 'cui_str': 'HIV positive'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0231218', 'cui_str': 'Malaise'}, {'cui': 'C0243009', 'cui_str': 'CD4+ Cell Counts'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0439243', 'cui_str': 'uL'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0149651', 'cui_str': 'Clubbing'}, {'cui': 'C0442529', 'cui_str': 'Urban environment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0679133', 'cui_str': 'Respect'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0043445', 'cui_str': 'Zambia'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0007589', 'cui_str': 'Differentiation, Cell'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0205615', 'cui_str': 'Well differentiated'}]","[{'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0243009', 'cui_str': 'CD4+ Cell Counts'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0001593', 'cui_str': 'Adoption'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}]",10.0,0.184599,Median MPR was 100% in intervention participants compared to 96% in control participants (p < 0.001).,"[{'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Roy', 'Affiliation': 'University of California, San Francisco, San Fancisco, California, United States of America.'}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Bolton-Moore', 'Affiliation': 'Centre for Infectious Disease Research in Zambia, Lusaka, Zambia.'}, {'ForeName': 'Izukanji', 'Initials': 'I', 'LastName': 'Sikazwe', 'Affiliation': 'Centre for Infectious Disease Research in Zambia, Lusaka, Zambia.'}, {'ForeName': 'Mpande', 'Initials': 'M', 'LastName': 'Mukumbwa-Mwenechanya', 'Affiliation': 'Centre for Infectious Disease Research in Zambia, Lusaka, Zambia.'}, {'ForeName': 'Emilie', 'Initials': 'E', 'LastName': 'Efronson', 'Affiliation': 'Centre for Infectious Disease Research in Zambia, Lusaka, Zambia.'}, {'ForeName': 'Chanda', 'Initials': 'C', 'LastName': 'Mwamba', 'Affiliation': 'Centre for Infectious Disease Research in Zambia, Lusaka, Zambia.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Somwe', 'Affiliation': 'Centre for Infectious Disease Research in Zambia, Lusaka, Zambia.'}, {'ForeName': 'Estella', 'Initials': 'E', 'LastName': 'Kalunkumya', 'Affiliation': 'Centre for Infectious Disease Research in Zambia, Lusaka, Zambia.'}, {'ForeName': 'Mwansa', 'Initials': 'M', 'LastName': 'Lumpa', 'Affiliation': 'Centre for Infectious Disease Research in Zambia, Lusaka, Zambia.'}, {'ForeName': 'Anjali', 'Initials': 'A', 'LastName': 'Sharma', 'Affiliation': 'Centre for Infectious Disease Research in Zambia, Lusaka, Zambia.'}, {'ForeName': 'Jake', 'Initials': 'J', 'LastName': 'Pry', 'Affiliation': 'Centre for Infectious Disease Research in Zambia, Lusaka, Zambia.'}, {'ForeName': 'Wilbroad', 'Initials': 'W', 'LastName': 'Mutale', 'Affiliation': 'Centre for Infectious Disease Research in Zambia, Lusaka, Zambia.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Ehrenkranz', 'Affiliation': 'Bill and Melinda Gates Foundation, Seattle, Washington, United States of America.'}, {'ForeName': 'David V', 'Initials': 'DV', 'LastName': 'Glidden', 'Affiliation': 'University of California, San Francisco, San Fancisco, California, United States of America.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Padian', 'Affiliation': 'University of California, Berkeley, Berkeley, California, United States of America.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Topp', 'Affiliation': 'James Cook University, Townsville, Queensland, Australia.'}, {'ForeName': 'Elvin', 'Initials': 'E', 'LastName': 'Geng', 'Affiliation': 'University of California, San Francisco, San Fancisco, California, United States of America.'}, {'ForeName': 'Charles B', 'Initials': 'CB', 'LastName': 'Holmes', 'Affiliation': 'Johns Hopkins University, Baltimore, Maryland, United States of America.'}]",PLoS medicine,['10.1371/journal.pmed.1003116'] 2635,32609805,Evaluation of a Safety Awareness Group Program for Adults With Intellectual Disability.,"Using a participatory research approach, we enlisted 12 U.S. Centers for Independent Living (CILs) to recruit and enroll 170 adults with intellectual disability (ID) to be randomized to either The Safety Class, an abuse prevention group program, or usual care. Participants were asked to complete pre, post, and 3-month follow-up questionnaires. CIL staff members facilitated the eight-session, interactive program. Quantitative and qualitative findings suggest that participation in a brief safety program may improve safety protective factors among men and women with ID. The Safety Class serves as one model for delivering an abuse prevention and education intervention to adults with significant safety needs but extremely limited access to relevant community resources.",2020,Quantitative and qualitative findings suggest that participation in a brief safety program may improve safety protective factors among men and women with ID.,"['enlisted 12 U.S. Centers for Independent Living (CILs) to recruit and enroll 170 adults with intellectual disability (ID', 'Adults With Intellectual Disability', 'men and women with ID']","['Safety Class, an abuse prevention group program, or usual care']",['safety protective factors'],"[{'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C4517599', 'cui_str': '170'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C3714756', 'cui_str': 'Intellectual disability'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C1261558', 'cui_str': 'Abuse prevention'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0679688', 'cui_str': 'Protective Factors'}]",170.0,0.028335,Quantitative and qualitative findings suggest that participation in a brief safety program may improve safety protective factors among men and women with ID.,"[{'ForeName': 'Rosemary B', 'Initials': 'RB', 'LastName': 'Hughes', 'Affiliation': 'University of Montana.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Robinson-Whelen', 'Affiliation': 'Baylor College of Medicine and TIRR Memorial Hermann.'}, {'ForeName': 'Leigh Ann', 'Initials': 'LA', 'LastName': 'Davis', 'Affiliation': 'Criminal Justice Initiatives of The Arc.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Meadours', 'Affiliation': 'League of Self Advocates.'}, {'ForeName': 'Olivia', 'Initials': 'O', 'LastName': 'Kincaid', 'Affiliation': 'Ravalli People First.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Howard', 'Affiliation': 'Ravalli People First.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Millin', 'Affiliation': 'Summit Independent Living Center.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Schwartz', 'Affiliation': 'SAFE - Disability Services.'}, {'ForeName': 'Katherine E', 'Initials': 'KE', 'LastName': 'McDonald', 'Affiliation': 'Syracuse University.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",American journal on intellectual and developmental disabilities,['10.1352/1944-7558-125.4.304'] 2636,32609812,INTELLANCE 2/EORTC 1410 randomized phase II study of Depatux-M alone and with temozolomide vs temozolomide or lomustine in recurrent EGFR amplified glioblastoma.,,2020,,['recurrent EGFR amplified glioblastoma'],"['Depatux-M alone and with temozolomide vs temozolomide or lomustine', '2/EORTC']",[],"[{'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0017636', 'cui_str': 'Glioblastoma'}]","[{'cui': 'C4477221', 'cui_str': 'depatuxizumab mafodotin'}, {'cui': 'C0076080', 'cui_str': 'temozolomide'}, {'cui': 'C0023972', 'cui_str': 'Lomustine'}]",[],,0.0162096,,"[{'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'van den Bent', 'Affiliation': ''}, {'ForeName': 'Marica', 'Initials': 'M', 'LastName': 'Eoli', 'Affiliation': ''}, {'ForeName': 'Juan Manuel', 'Initials': 'JM', 'LastName': 'Sepulveda', 'Affiliation': ''}, {'ForeName': 'Marion', 'Initials': 'M', 'LastName': 'Smits', 'Affiliation': ''}, {'ForeName': 'Annemiek', 'Initials': 'A', 'LastName': 'Walenkamp', 'Affiliation': ''}, {'ForeName': 'Jean-Sebastian', 'Initials': 'JS', 'LastName': 'Frenel', 'Affiliation': ''}, {'ForeName': 'Enrico', 'Initials': 'E', 'LastName': 'Franceschi', 'Affiliation': ''}, {'ForeName': 'Paul M', 'Initials': 'PM', 'LastName': 'Clement', 'Affiliation': ''}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Chinot', 'Affiliation': ''}, {'ForeName': 'Filip', 'Initials': 'F', 'LastName': 'de Vos', 'Affiliation': ''}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Whenham', 'Affiliation': ''}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Sanghera', 'Affiliation': ''}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Weller', 'Affiliation': ''}, {'ForeName': 'H J', 'Initials': 'HJ', 'LastName': 'Dubbink', 'Affiliation': ''}, {'ForeName': 'Pim', 'Initials': 'P', 'LastName': 'French', 'Affiliation': ''}, {'ForeName': 'Jim', 'Initials': 'J', 'LastName': 'Looman', 'Affiliation': ''}, {'ForeName': 'Jyotirmoy', 'Initials': 'J', 'LastName': 'Dey', 'Affiliation': ''}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Krause', 'Affiliation': ''}, {'ForeName': 'Pete', 'Initials': 'P', 'LastName': 'Ansell', 'Affiliation': ''}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Nuyens', 'Affiliation': ''}, {'ForeName': 'Maarten', 'Initials': 'M', 'LastName': 'Spruyt', 'Affiliation': ''}, {'ForeName': 'Joana', 'Initials': 'J', 'LastName': 'Brilhante', 'Affiliation': ''}, {'ForeName': 'Corneel', 'Initials': 'C', 'LastName': 'Coens', 'Affiliation': ''}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Gorlia', 'Affiliation': ''}, {'ForeName': 'Vassilis', 'Initials': 'V', 'LastName': 'Golfinopoulos', 'Affiliation': ''}]",Neuro-oncology,['10.1093/neuonc/noaa115'] 2637,32609847,Exploratory analyses of the popularity and efficacy of four behavioral methods of gradual smoking cessation.,"INTRODUCTION Around half of smokers attempt to stop by cutting-down first. Evidence suggests this results in similar quit rates to abrupt quitting. Evidence for the effectiveness and popularity of different gradual cessation methods is sparse. METHOD Secondary, exploratory, analyses of a randomized trial of gradual versus abrupt smoking cessation. Gradual participants (N=342) chose between four methods of cutting-down over two weeks: cutting-out the easiest cigarettes first (HR-E); cutting-out the most difficult cigarettes first (HR-D); smoking on an increasing time schedule (SR); and not smoking during particular periods (SFP). Nicotine replacement therapy and behavioral support were provided before and after quit day. We used logistic and linear regression modelling to test whether method chosen was associated with smoking reduction, quit attempts, and abstinence, whilst adjusting for potential confounders. RESULTS Participants were on average 49 years old, smoked 20 cigarettes per day, and had an FTCD of 6. 14.9% (51/342) chose HR-E, 2.1% (7/342) HR-D, 46.2% (158/342) SFP, and 36.8% (126/342) SR. We found no evidence of adjusted or unadjusted associations between method and successful 75% reduction in cigarette consumption, reduction in percentage cigarettes per day or exhaled carbon monoxide, quit attempts, or abstinence at four-week or six-month follow-up. CONCLUSIONS Future research and practice could focus more heavily on the SR and SFP methods as these appeared notably more popular than HR. There was substantial imprecision in the efficacy data, which should be treated with caution; however none of the gradual cessation methods showed clear evidence of being more efficacious than others.",2020,"We used logistic and linear regression modelling to test whether method chosen was associated with smoking reduction, quit attempts, and abstinence, whilst adjusting for potential confounders. ","['Participants were on average 49 years old, smoked 20 cigarettes per day, and had an FTCD of 6']","['Nicotine replacement therapy', 'cutting-out the easiest cigarettes first (HR-E); cutting-out the most difficult cigarettes first (HR-D); smoking on an increasing time schedule (SR); and not smoking during particular periods (SFP']","['cigarette consumption, reduction in percentage cigarettes per day or exhaled carbon monoxide, quit attempts, or abstinence']","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0439505', 'cui_str': '/day'}]","[{'cui': 'C1278444', 'cui_str': 'Nicotine replacement therapy'}, {'cui': 'C0000925', 'cui_str': 'Incised wound'}, {'cui': 'C0332219', 'cui_str': 'Easy'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0332218', 'cui_str': 'Difficult'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0075029', 'cui_str': 'spleen fibrinolytic proteinase (human)'}]","[{'cui': 'C0459840', 'cui_str': 'Cigarette consumption'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0439505', 'cui_str': '/day'}, {'cui': 'C0007018', 'cui_str': 'Carbon Monoxide'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}]",,0.0340359,"We used logistic and linear regression modelling to test whether method chosen was associated with smoking reduction, quit attempts, and abstinence, whilst adjusting for potential confounders. ","[{'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Lindson', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, UK.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Michie', 'Affiliation': 'Centre for Behaviour Change, University College London, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Aveyard', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, UK.'}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/ntaa123'] 2638,32609858,"Psychoeducation Program for Substance Use Disorder: Effect on Relapse Rate, Social Functioning, Perceived Wellness, and Coping.","The current study was designed to assess the effect of a psychoeducation program on relapse rate, social functioning, perceived wellness, and ways of coping in individuals with substance use disorder (SUD). The study sample comprised 92 individuals (n = 46 intervention group, n = 46 control group) who received SUD treatment, had undergone detoxification, and agreed to participate in the study. A 10-session psychoeducation program was applied to individuals in the intervention group. Data collection included a urine sample and completion of the Personal Information Form, Social Functioning Scale, Perceived Wellness Scale, and Ways of Coping Scale. The relapse rate in the control group was found to be higher than in the intervention group; thus, it was determined that the relapse prevention psychoeducation program led to positive changes in relapse rate, social functioning, perceived wellness, and stress in individuals with SUD. [Journal of Psychosocial Nursing and Mental Health Services, xx(x), xx-xx.].",2020,"The relapse rate in the control group was found to be higher than in the intervention group; thus, it was determined that the relapse prevention psychoeducation program led to positive changes in relapse rate, social functioning, perceived wellness, and stress in individuals with SUD.","['individuals with substance use disorder (SUD', '92 individuals (n = 46 intervention group, n = 46 control group) who received SUD treatment, had undergone detoxification, and agreed to participate in the study']",['psychoeducation program'],"['relapse rate, social functioning, perceived wellness, and stress in individuals with SUD', 'relapse rate', 'urine sample and completion of the Personal Information Form, Social Functioning Scale, Perceived Wellness Scale, and Ways of Coping Scale', 'Relapse Rate, Social Functioning, Perceived Wellness, and Coping', 'relapse rate, social functioning, perceived wellness, and ways of coping']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0038586', 'cui_str': 'Substance use disorder'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0025516', 'cui_str': 'Detoxication, Drug, Metabolic'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0871175', 'cui_str': 'Psychoeducation'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0037395', 'cui_str': 'Social adjustment'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0038586', 'cui_str': 'Substance use disorder'}, {'cui': 'C1610733', 'cui_str': 'Urine specimen'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C2983694', 'cui_str': 'Personally Identifiable Information'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C2585826', 'cui_str': 'Social functioning scale'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0009967', 'cui_str': 'Coping behavior'}]",,0.0150981,"The relapse rate in the control group was found to be higher than in the intervention group; thus, it was determined that the relapse prevention psychoeducation program led to positive changes in relapse rate, social functioning, perceived wellness, and stress in individuals with SUD.","[{'ForeName': 'Maral', 'Initials': 'M', 'LastName': 'Kargin', 'Affiliation': ''}, {'ForeName': 'Duygu', 'Initials': 'D', 'LastName': 'Hicdurmaz', 'Affiliation': ''}]",Journal of psychosocial nursing and mental health services,['10.3928/02793695-20200624-03'] 2639,32609979,Amoxicillin for 3 or 5 Days for Chest-Indrawing Pneumonia in Malawian Children.,"BACKGROUND Evidence regarding the appropriate duration of treatment with antibiotic agents in children with pneumonia in low-resource settings in Africa is lacking. METHODS We conducted a double-blind, randomized, controlled, noninferiority trial in Lilongwe, Malawi, to determine whether treatment with amoxicillin for 3 days is less effective than treatment for 5 days in children with chest-indrawing pneumonia (cough lasting <14 days or difficulty breathing, along with visible indrawing of the chest wall with or without fast breathing for age). Children not infected with human immunodeficiency virus (HIV) who were 2 to 59 months of age and had chest-indrawing pneumonia were randomly assigned to receive amoxicillin twice daily for either 3 days or 5 days. Children were followed for 14 days. The primary outcome was treatment failure by day 6; noninferiority of the 3-day regimen to the 5-day regimen would be shown if the percentage of children with treatment failure in the 3-day group was no more than 1.5 times that in the 5-day group. Prespecified secondary analyses included assessment of treatment failure or relapse by day 14. RESULTS From March 29, 2016, to April 1, 2019, a total of 3000 children underwent randomization: 1497 children were assigned to the 3-day group, and 1503 to the 5-day group. Among children with day 6 data available, treatment failure had occurred in 5.9% in the 3-day group (85 of 1442 children) and in 5.2% (75 of 1456) in the 5-day group (adjusted difference, 0.7 percentage points; 95% confidence interval [CI], -0.9 to 2.4) - a result that satisfied the criterion for noninferiority of the 3-day regimen to the 5-day regimen. Among children with day 14 data available, 176 of 1411 children (12.5%) in the 3-day group and 154 of 1429 (10.8%) in the 5-day group had had treatment failure by day 6 or relapse by day 14 (between-group difference, 1.7 percentage points; 95% CI, -0.7 to 4.1). The percentage of children with serious adverse events was similar in the two groups (9.8% in the 3-day group and 8.8% in the 5-day group). CONCLUSIONS In HIV-uninfected Malawian children, treatment with amoxicillin for chest-indrawing pneumonia for 3 days was noninferior to treatment for 5 days. (Funded by the Bill and Melinda Gates Foundation; ClinicalTrials.gov number, NCT02678195.).",2020,"The percentage of children with serious adverse events was similar in the two groups (9.8% in the 3-day group and 8.8% in the 5-day group). ","['1497 children', 'children with chest-indrawing pneumonia (cough lasting <14 days or difficulty breathing, along with visible indrawing of the chest wall with or without fast breathing for age', 'Children not infected with human immunodeficiency virus (HIV) who were 2 to 59 months of age and had chest-indrawing pneumonia', 'Malawian Children', '3000 children underwent randomization', 'children with pneumonia in low-resource settings in Africa']","['amoxicillin', 'antibiotic agents', 'Amoxicillin']","['percentage of children with treatment failure', 'assessment of treatment failure or relapse by day 14', 'percentage of children with serious adverse events', 'treatment failure by day 6 or relapse']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0817096', 'cui_str': 'Thoracic'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0205379', 'cui_str': 'Visible'}, {'cui': 'C0205076', 'cui_str': 'Chest wall structure'}, {'cui': 'C0231835', 'cui_str': 'Tachypnea'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0470279', 'cui_str': '3000'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0001737', 'cui_str': 'Africa'}]","[{'cui': 'C0002645', 'cui_str': 'Amoxicillin'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}]","[{'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0680063', 'cui_str': 'Child of'}, {'cui': 'C0521983', 'cui_str': 'Absence of therapeutic response'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",3000.0,0.259317,"The percentage of children with serious adverse events was similar in the two groups (9.8% in the 3-day group and 8.8% in the 5-day group). ","[{'ForeName': 'Amy-Sarah', 'Initials': 'AS', 'LastName': 'Ginsburg', 'Affiliation': 'From the Department of Biostatistics, University of Washington Clinical Trial Center, Seattle (A.-S.G., R.S., J.H., S.M.); the University of North Carolina Project, Lilongwe Medical Relief Fund Trust, Tidziwe Centre (T.M., M.P., C.B.N.), and Acute Respiratory Infection and Emergency Triage Assessment and Treatment, Malawi Ministry of Health (N.L.), Lilongwe, and the Department of Pediatrics and Child Health, College of Medicine, University of Malawi, Blantyre (A.P.) - all in Malawi; Save the Children, Fairfield, CT (E.N.); and Eudowood Division of Pediatric Respiratory Sciences, Department of Pediatrics, Johns Hopkins School of Medicine and Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore (E.D.M.).'}, {'ForeName': 'Tisungane', 'Initials': 'T', 'LastName': 'Mvalo', 'Affiliation': 'From the Department of Biostatistics, University of Washington Clinical Trial Center, Seattle (A.-S.G., R.S., J.H., S.M.); the University of North Carolina Project, Lilongwe Medical Relief Fund Trust, Tidziwe Centre (T.M., M.P., C.B.N.), and Acute Respiratory Infection and Emergency Triage Assessment and Treatment, Malawi Ministry of Health (N.L.), Lilongwe, and the Department of Pediatrics and Child Health, College of Medicine, University of Malawi, Blantyre (A.P.) - all in Malawi; Save the Children, Fairfield, CT (E.N.); and Eudowood Division of Pediatric Respiratory Sciences, Department of Pediatrics, Johns Hopkins School of Medicine and Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore (E.D.M.).'}, {'ForeName': 'Evangelyn', 'Initials': 'E', 'LastName': 'Nkwopara', 'Affiliation': 'From the Department of Biostatistics, University of Washington Clinical Trial Center, Seattle (A.-S.G., R.S., J.H., S.M.); the University of North Carolina Project, Lilongwe Medical Relief Fund Trust, Tidziwe Centre (T.M., M.P., C.B.N.), and Acute Respiratory Infection and Emergency Triage Assessment and Treatment, Malawi Ministry of Health (N.L.), Lilongwe, and the Department of Pediatrics and Child Health, College of Medicine, University of Malawi, Blantyre (A.P.) - all in Malawi; Save the Children, Fairfield, CT (E.N.); and Eudowood Division of Pediatric Respiratory Sciences, Department of Pediatrics, Johns Hopkins School of Medicine and Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore (E.D.M.).'}, {'ForeName': 'Eric D', 'Initials': 'ED', 'LastName': 'McCollum', 'Affiliation': 'From the Department of Biostatistics, University of Washington Clinical Trial Center, Seattle (A.-S.G., R.S., J.H., S.M.); the University of North Carolina Project, Lilongwe Medical Relief Fund Trust, Tidziwe Centre (T.M., M.P., C.B.N.), and Acute Respiratory Infection and Emergency Triage Assessment and Treatment, Malawi Ministry of Health (N.L.), Lilongwe, and the Department of Pediatrics and Child Health, College of Medicine, University of Malawi, Blantyre (A.P.) - all in Malawi; Save the Children, Fairfield, CT (E.N.); and Eudowood Division of Pediatric Respiratory Sciences, Department of Pediatrics, Johns Hopkins School of Medicine and Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore (E.D.M.).'}, {'ForeName': 'Melda', 'Initials': 'M', 'LastName': 'Phiri', 'Affiliation': 'From the Department of Biostatistics, University of Washington Clinical Trial Center, Seattle (A.-S.G., R.S., J.H., S.M.); the University of North Carolina Project, Lilongwe Medical Relief Fund Trust, Tidziwe Centre (T.M., M.P., C.B.N.), and Acute Respiratory Infection and Emergency Triage Assessment and Treatment, Malawi Ministry of Health (N.L.), Lilongwe, and the Department of Pediatrics and Child Health, College of Medicine, University of Malawi, Blantyre (A.P.) - all in Malawi; Save the Children, Fairfield, CT (E.N.); and Eudowood Division of Pediatric Respiratory Sciences, Department of Pediatrics, Johns Hopkins School of Medicine and Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore (E.D.M.).'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Schmicker', 'Affiliation': 'From the Department of Biostatistics, University of Washington Clinical Trial Center, Seattle (A.-S.G., R.S., J.H., S.M.); the University of North Carolina Project, Lilongwe Medical Relief Fund Trust, Tidziwe Centre (T.M., M.P., C.B.N.), and Acute Respiratory Infection and Emergency Triage Assessment and Treatment, Malawi Ministry of Health (N.L.), Lilongwe, and the Department of Pediatrics and Child Health, College of Medicine, University of Malawi, Blantyre (A.P.) - all in Malawi; Save the Children, Fairfield, CT (E.N.); and Eudowood Division of Pediatric Respiratory Sciences, Department of Pediatrics, Johns Hopkins School of Medicine and Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore (E.D.M.).'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Hwang', 'Affiliation': 'From the Department of Biostatistics, University of Washington Clinical Trial Center, Seattle (A.-S.G., R.S., J.H., S.M.); the University of North Carolina Project, Lilongwe Medical Relief Fund Trust, Tidziwe Centre (T.M., M.P., C.B.N.), and Acute Respiratory Infection and Emergency Triage Assessment and Treatment, Malawi Ministry of Health (N.L.), Lilongwe, and the Department of Pediatrics and Child Health, College of Medicine, University of Malawi, Blantyre (A.P.) - all in Malawi; Save the Children, Fairfield, CT (E.N.); and Eudowood Division of Pediatric Respiratory Sciences, Department of Pediatrics, Johns Hopkins School of Medicine and Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore (E.D.M.).'}, {'ForeName': 'Chifundo B', 'Initials': 'CB', 'LastName': 'Ndamala', 'Affiliation': 'From the Department of Biostatistics, University of Washington Clinical Trial Center, Seattle (A.-S.G., R.S., J.H., S.M.); the University of North Carolina Project, Lilongwe Medical Relief Fund Trust, Tidziwe Centre (T.M., M.P., C.B.N.), and Acute Respiratory Infection and Emergency Triage Assessment and Treatment, Malawi Ministry of Health (N.L.), Lilongwe, and the Department of Pediatrics and Child Health, College of Medicine, University of Malawi, Blantyre (A.P.) - all in Malawi; Save the Children, Fairfield, CT (E.N.); and Eudowood Division of Pediatric Respiratory Sciences, Department of Pediatrics, Johns Hopkins School of Medicine and Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore (E.D.M.).'}, {'ForeName': 'Ajib', 'Initials': 'A', 'LastName': 'Phiri', 'Affiliation': 'From the Department of Biostatistics, University of Washington Clinical Trial Center, Seattle (A.-S.G., R.S., J.H., S.M.); the University of North Carolina Project, Lilongwe Medical Relief Fund Trust, Tidziwe Centre (T.M., M.P., C.B.N.), and Acute Respiratory Infection and Emergency Triage Assessment and Treatment, Malawi Ministry of Health (N.L.), Lilongwe, and the Department of Pediatrics and Child Health, College of Medicine, University of Malawi, Blantyre (A.P.) - all in Malawi; Save the Children, Fairfield, CT (E.N.); and Eudowood Division of Pediatric Respiratory Sciences, Department of Pediatrics, Johns Hopkins School of Medicine and Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore (E.D.M.).'}, {'ForeName': 'Norman', 'Initials': 'N', 'LastName': 'Lufesi', 'Affiliation': 'From the Department of Biostatistics, University of Washington Clinical Trial Center, Seattle (A.-S.G., R.S., J.H., S.M.); the University of North Carolina Project, Lilongwe Medical Relief Fund Trust, Tidziwe Centre (T.M., M.P., C.B.N.), and Acute Respiratory Infection and Emergency Triage Assessment and Treatment, Malawi Ministry of Health (N.L.), Lilongwe, and the Department of Pediatrics and Child Health, College of Medicine, University of Malawi, Blantyre (A.P.) - all in Malawi; Save the Children, Fairfield, CT (E.N.); and Eudowood Division of Pediatric Respiratory Sciences, Department of Pediatrics, Johns Hopkins School of Medicine and Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore (E.D.M.).'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'May', 'Affiliation': 'From the Department of Biostatistics, University of Washington Clinical Trial Center, Seattle (A.-S.G., R.S., J.H., S.M.); the University of North Carolina Project, Lilongwe Medical Relief Fund Trust, Tidziwe Centre (T.M., M.P., C.B.N.), and Acute Respiratory Infection and Emergency Triage Assessment and Treatment, Malawi Ministry of Health (N.L.), Lilongwe, and the Department of Pediatrics and Child Health, College of Medicine, University of Malawi, Blantyre (A.P.) - all in Malawi; Save the Children, Fairfield, CT (E.N.); and Eudowood Division of Pediatric Respiratory Sciences, Department of Pediatrics, Johns Hopkins School of Medicine and Department of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore (E.D.M.).'}]",The New England journal of medicine,['10.1056/NEJMoa1912400'] 2640,32609980,Randomized Trial of Amoxicillin for Pneumonia in Pakistan.,"BACKGROUND The World Health Organization (WHO) recommends oral amoxicillin for patients who have pneumonia with tachypnea, yet trial data indicate that not using amoxicillin to treat this condition may be noninferior to using amoxicillin. METHODS We conducted a double-blind, randomized, placebo-controlled noninferiority trial involving children at primary health care centers in low-income communities in Karachi, Pakistan. Children who were 2 to 59 months of age and who met WHO criteria for nonsevere pneumonia with tachypnea were randomly assigned to a 3-day course of a suspension of amoxicillin (the active control) of 50 mg per milliliter or matched volume of placebo (the test regimen), according to WHO weight bands (500 mg every 12 hours for a weight of 4 to <10 kg, 1000 mg every 12 hours for a weight of 10 to <14 kg, or 1500 mg every 12 hours for a weight of 14 to <20 kg). The primary outcome was treatment failure during the 3-day course of amoxicillin or placebo. The prespecified noninferiority margin was 1.75 percentage points. RESULTS From November 9, 2014, through November 30, 2017, a total of 4002 children underwent randomization (1999 in the placebo group and 2003 in the amoxicillin group). In the per-protocol analysis, the incidence of treatment failure was 4.9% among placebo recipients (95 of 1927 children) and 2.6% among amoxicillin recipients (51 of 1929 children) (between-group difference, 2.3 percentage points; 95% confidence interval [CI], 0.9 to 3.7). Results were similar in the intention-to-treat analysis. The presence of fever and wheeze predicted treatment failure. The number needed to treat to prevent one treatment failure was 44 (95% CI, 31 to 80). One patient (<0.1%) in each group died. Relapse occurred in 40 children (2.2%) in the placebo group and in 58 children (3.1%) in the amoxicillin group. CONCLUSIONS Among children younger than 5 years of age with nonsevere pneumonia, the frequency of treatment failure was higher in the placebo group than in the amoxicillin group, a difference that did not meet the noninferiority margin for placebo. (Funded by the Joint Global Health Trials Scheme [of the Department for International Development, Medical Research Council, and Wellcome] and others; RETAPP ClinicalTrials.gov number, NCT02372461.).",2020,"Relapse occurred in 40 children (2.2%) in the placebo group and in 58 children (3.1%) in the amoxicillin group. ","['patients who have pneumonia with tachypnea', 'Children who were 2 to 59 months of age and who met WHO criteria for nonsevere pneumonia with tachypnea', 'children at primary health care centers in low-income communities in Karachi, Pakistan', 'Pneumonia in Pakistan', 'children younger than 5 years of age with nonsevere pneumonia', 'From November 9, 2014, through November 30, 2017, a total of 4002 children underwent randomization (1999 in the placebo group and 2003 in the']","['amoxicillin', 'suspension of amoxicillin (the active control) of 50 mg per milliliter or matched volume of placebo', 'Amoxicillin', 'placebo']","['Relapse', 'number needed to treat to prevent one treatment failure', 'treatment failure during the 3-day course of amoxicillin or placebo', 'incidence of treatment failure', 'frequency of treatment failure']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0231835', 'cui_str': 'Tachypnea'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0043237', 'cui_str': 'Organization, World Health'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0030211', 'cui_str': 'Pakistan'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0002645', 'cui_str': 'Amoxicillin'}, {'cui': 'C0007985', 'cui_str': 'Chemical suspension'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439526', 'cui_str': '/mL'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C3179138', 'cui_str': 'Numbers Needed To Treat'}, {'cui': 'C1292733', 'cui_str': 'Prevents'}, {'cui': 'C0521983', 'cui_str': 'Absence of therapeutic response'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0002645', 'cui_str': 'Amoxicillin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}]",4002.0,0.735183,"Relapse occurred in 40 children (2.2%) in the placebo group and in 58 children (3.1%) in the amoxicillin group. ","[{'ForeName': 'Fyezah', 'Initials': 'F', 'LastName': 'Jehan', 'Affiliation': 'From Aga Khan University, Karachi, Pakistan (F.J., I.N., S.K., B.B., N.B., N.R., A.R., Y.S., A.K.M.Z.); Uppsala University, Uppsala, Sweden (N.B.); and the Bill and Melinda Gates Foundation, Seattle (A.K.M.Z.).'}, {'ForeName': 'Imran', 'Initials': 'I', 'LastName': 'Nisar', 'Affiliation': 'From Aga Khan University, Karachi, Pakistan (F.J., I.N., S.K., B.B., N.B., N.R., A.R., Y.S., A.K.M.Z.); Uppsala University, Uppsala, Sweden (N.B.); and the Bill and Melinda Gates Foundation, Seattle (A.K.M.Z.).'}, {'ForeName': 'Salima', 'Initials': 'S', 'LastName': 'Kerai', 'Affiliation': 'From Aga Khan University, Karachi, Pakistan (F.J., I.N., S.K., B.B., N.B., N.R., A.R., Y.S., A.K.M.Z.); Uppsala University, Uppsala, Sweden (N.B.); and the Bill and Melinda Gates Foundation, Seattle (A.K.M.Z.).'}, {'ForeName': 'Benazir', 'Initials': 'B', 'LastName': 'Balouch', 'Affiliation': 'From Aga Khan University, Karachi, Pakistan (F.J., I.N., S.K., B.B., N.B., N.R., A.R., Y.S., A.K.M.Z.); Uppsala University, Uppsala, Sweden (N.B.); and the Bill and Melinda Gates Foundation, Seattle (A.K.M.Z.).'}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Brown', 'Affiliation': 'From Aga Khan University, Karachi, Pakistan (F.J., I.N., S.K., B.B., N.B., N.R., A.R., Y.S., A.K.M.Z.); Uppsala University, Uppsala, Sweden (N.B.); and the Bill and Melinda Gates Foundation, Seattle (A.K.M.Z.).'}, {'ForeName': 'Najeeb', 'Initials': 'N', 'LastName': 'Rahman', 'Affiliation': 'From Aga Khan University, Karachi, Pakistan (F.J., I.N., S.K., B.B., N.B., N.R., A.R., Y.S., A.K.M.Z.); Uppsala University, Uppsala, Sweden (N.B.); and the Bill and Melinda Gates Foundation, Seattle (A.K.M.Z.).'}, {'ForeName': 'Arjumand', 'Initials': 'A', 'LastName': 'Rizvi', 'Affiliation': 'From Aga Khan University, Karachi, Pakistan (F.J., I.N., S.K., B.B., N.B., N.R., A.R., Y.S., A.K.M.Z.); Uppsala University, Uppsala, Sweden (N.B.); and the Bill and Melinda Gates Foundation, Seattle (A.K.M.Z.).'}, {'ForeName': 'Yasir', 'Initials': 'Y', 'LastName': 'Shafiq', 'Affiliation': 'From Aga Khan University, Karachi, Pakistan (F.J., I.N., S.K., B.B., N.B., N.R., A.R., Y.S., A.K.M.Z.); Uppsala University, Uppsala, Sweden (N.B.); and the Bill and Melinda Gates Foundation, Seattle (A.K.M.Z.).'}, {'ForeName': 'Anita K M', 'Initials': 'AKM', 'LastName': 'Zaidi', 'Affiliation': 'From Aga Khan University, Karachi, Pakistan (F.J., I.N., S.K., B.B., N.B., N.R., A.R., Y.S., A.K.M.Z.); Uppsala University, Uppsala, Sweden (N.B.); and the Bill and Melinda Gates Foundation, Seattle (A.K.M.Z.).'}]",The New England journal of medicine,['10.1056/NEJMoa1911998'] 2641,32610059,Behavioral economics informed message content in text message reminders to improve cervical screening participation: Two pragmatic randomized controlled trials.,"The objective of the reported research was to assess the impact of text message (SMS) reminders and their content on cervical screening rates. Women invited for cervical screening in Northwest London from February-October 2015 were eligible. 3133 women aged 24-29 (Study 1) were randomized (1, 1) to 'no SMS' (control), or a primary care physician (PCP) endorsed SMS (SMS-PCP). 11,405 women aged 30-64 (Study 2), were randomized (1, 1:1:1:1:1:1) to either: no SMS, an SMS without manipulation (SMS), the SMS-PCP, an SMS with a total or proportionate social norm (SMS-SNT or SMS-SNP), or an SMS with a gain-framed or loss-framed message (SMS-GF and SMS-LF). The primary outcome was participation at 18 weeks. In Study 1 participation was significantly higher in the SMS-PCP arm (31.4%) compared to control (26.4%, aOR, 1.29, 95%CI: 1.09-1·51; p = 0.002). In Study 2 participation was highest in the SMS-PCP (38.4%) and SMS (38.1%) arms compared to control (34.4%), (aOR: 1.19, 95%CI: 1.03-1.38; p = 0.02 and aOR: 1.18, 95%CI: 1.02-1.37; p = 0.03, respectively). The results demonstrate that behavioral SMSs improve cervical screening participation. The message content plays an important role in the impact of SMS. The results from this trial have already been used to designing effective policy for cervical cancer screening. The NHS Cervical Screening Programme started running a London-wide screening campaign which was based on the cervical screening trial described here. According to figures published by Public Health England, after six months attendance increased by 4.8%, which is the equivalent of 13,400 more women being screened at 18 weeks.",2020,"In Study 1 participation was significantly higher in the SMS-PCP arm (31.4%) compared to control (26.4%, aOR, 1.29, 95%CI: 1.09-1·51; p = 0.002).","['3133 women aged 24-29 (Study 1', 'Women invited for cervical screening in Northwest London from February-October 2015 were eligible', '11,405 women aged 30-64 (Study 2']","['behavioral SMSs', ""no SMS' (control), or a primary care physician (PCP) endorsed SMS (SMS-PCP""]","['cervical screening participation', 'SMS-PCP', 'cervical screening rates']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0023973', 'cui_str': 'London'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0033131', 'cui_str': 'Primary care physician'}]","[{'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0795864', 'cui_str': 'Smith-Magenis syndrome'}, {'cui': 'C0033131', 'cui_str': 'Primary care physician'}]",11405.0,0.199584,"In Study 1 participation was significantly higher in the SMS-PCP arm (31.4%) compared to control (26.4%, aOR, 1.29, 95%CI: 1.09-1·51; p = 0.002).","[{'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Huf', 'Affiliation': 'Department of Surgery and Cancer, Imperial College London, 10th Floor Queen Elizabeth Queen Mother Wing, Praed Street, London W2 1NY, UK; Center for Health Care Innovation, Perelman Center for Advanced Medicine, University of Pennsylvania, 14th Floor South Pavilion, Philadelphia, PA 19104, USA.'}, {'ForeName': 'Robert S', 'Initials': 'RS', 'LastName': 'Kerrison', 'Affiliation': 'Research Department of Behavioural Science and Health, University College London, London, UK.'}, {'ForeName': 'Dominic', 'Initials': 'D', 'LastName': 'King', 'Affiliation': 'Department of Surgery and Cancer, Imperial College London, 10th Floor Queen Elizabeth Queen Mother Wing, Praed Street, London W2 1NY, UK.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Chadborn', 'Affiliation': 'Public Health England, Wellington House, 133-155 Waterloo Road, London SE1 8UG, UK.'}, {'ForeName': 'Adele', 'Initials': 'A', 'LastName': 'Richmond', 'Affiliation': 'Breast Cancer Now, 5th Floor Ibex House, 42-47 Minories, London EC3N 1DY, UK.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Cunningham', 'Affiliation': 'West of London Breast Screening Service, Imperial College Healthcare NHS Trust, First Floor, Charing Cross Hospital, Fulham Palace Road, London W6 8RF, UK.'}, {'ForeName': 'Ellis', 'Initials': 'E', 'LastName': 'Friedman', 'Affiliation': 'Faculty of Public Health, 4 St Andrews Place, London NW1 4LB, UK.'}, {'ForeName': 'Heema', 'Initials': 'H', 'LastName': 'Shukla', 'Affiliation': 'Global Health Capacity, Unit 4, Vista Place, Coy Pond Business Park Ingworth Road, Poole, BH12 1JY, UK.'}, {'ForeName': 'Fu-Min', 'Initials': 'FM', 'LastName': 'Tseng', 'Affiliation': 'Department of Surgery and Cancer, Imperial College London, 10th Floor Queen Elizabeth Queen Mother Wing, Praed Street, London W2 1NY, UK.'}, {'ForeName': 'Gaby', 'Initials': 'G', 'LastName': 'Judah', 'Affiliation': 'Department of Surgery and Cancer, Imperial College London, 10th Floor Queen Elizabeth Queen Mother Wing, Praed Street, London W2 1NY, UK.'}, {'ForeName': 'Ara', 'Initials': 'A', 'LastName': 'Darzi', 'Affiliation': 'Department of Surgery and Cancer, Imperial College London, 10th Floor Queen Elizabeth Queen Mother Wing, Praed Street, London W2 1NY, UK.'}, {'ForeName': 'Ivo', 'Initials': 'I', 'LastName': 'Vlaev', 'Affiliation': 'Warwick Business School, University of Warwick, Scarman Rd, Coventry CV4 7AL, UK. Electronic address: ivo.vlaev@wbs.ac.uk.'}]",Preventive medicine,['10.1016/j.ypmed.2020.106170'] 2642,32610115,Suboptimal reliability of liver biopsy evaluation has implications for randomized clinical trials.,"BACKGROUND & AIMS Liver biopsies are a critical component of pivotal studies in nonalcoholic steatohepatitis (NASH) constituting main inclusion criteria, risk stratification factors and endpoints. We evaluated the reliability of NASH Clinical Research Network scoring of liver biopsies in a NASH clinical trial. METHODS Digitized slides from 678 biopsies for 339 patients with paired biopsies randomized into the EMMINENCE study examining a novel insulin sensitizer (MSDC-0602K) in NASH were read independently by three hepatopathologists blinded to treatment code and scored using the NASH CRN Histological Scoring System. Various endpoints were computed from these scores. RESULTS Inter-reader linearly weighted kappas were 0.609, 0.484, 0.328, and 0.517 for steatosis, fibrosis, lobular inflammation, and ballooning, respectively. Inter-reader unweighted kappas were 0.400 for the diagnosis of NASH, 0.396 for NASH resolution without worsening fibrosis, and 0.366 for fibrosis improvement without worsening NASH. In the current study, 46.3% of the patients included in the study based on one hepatopathologist's qualifying reading were deemed by at least one of the three hepatopathologists as not meeting the study's histologic inclusion criteria. The MSDC-0602K treatment effect was lowest for those histologic features with lower inter-reader reliability. Simulations show that the lack of reliability of endpoints and inclusion criteria can drastically reduce study power - from > 90% in a well-powered study to as low as 40%. CONCLUSIONS Reliability of hepatopathologists' liver biopsy evaluation using currently accepted criteria is suboptimal. This lack of reliability may affect NASH pivotal studies by introducing patients who do not meet NASH study entry criteria, misclassifying fibrosis subgroups, and attenuating apparent treatment effects.",2020,"RESULTS Inter-reader linearly weighted kappas were 0.609, 0.484, 0.328, and 0.517 for steatosis, fibrosis, lobular inflammation, and ballooning, respectively.",['Digitized slides from 678 biopsies for 339 patients with paired biopsies'],['novel insulin sensitizer (MSDC-0602K'],[],"[{'cui': 'C0332246', 'cui_str': 'Sliding'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0644896', 'cui_str': '10-methyl spiro(4.5)dec-6-en-6-carboxylic acid'}]",[],678.0,0.0934253,"RESULTS Inter-reader linearly weighted kappas were 0.609, 0.484, 0.328, and 0.517 for steatosis, fibrosis, lobular inflammation, and ballooning, respectively.","[{'ForeName': 'Beth A', 'Initials': 'BA', 'LastName': 'Davison', 'Affiliation': 'Momentum Research, Inc., Durham, NC, USA. Electronic address: bethdavison@momentum-research.com.'}, {'ForeName': 'Stephen A', 'Initials': 'SA', 'LastName': 'Harrison', 'Affiliation': 'Hepatology, Radcliffe Department of Medicine, University of Oxford, UK.'}, {'ForeName': 'Gad', 'Initials': 'G', 'LastName': 'Cotter', 'Affiliation': 'Momentum Research, Inc., Durham, NC, USA.'}, {'ForeName': 'Naim', 'Initials': 'N', 'LastName': 'Alkhouri', 'Affiliation': 'Texas Liver Institute, San Antonio, TX, USA.'}, {'ForeName': 'Arun', 'Initials': 'A', 'LastName': 'Sanyal', 'Affiliation': 'Virginia Commonwealth University School of Medicine, Richmond, Virginia, USA.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Edwards', 'Affiliation': 'Momentum Research, Inc., Durham, NC, USA.'}, {'ForeName': 'Jerry R', 'Initials': 'JR', 'LastName': 'Colca', 'Affiliation': 'Cirius Therapeutics, Inc., San Diego, CA, USA.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Iwashita', 'Affiliation': 'Cirius Therapeutics, Inc., San Diego, CA, USA.'}, {'ForeName': 'Gary G', 'Initials': 'GG', 'LastName': 'Koch', 'Affiliation': 'University of North Carolina, Chapel Hill, NC, USA.'}, {'ForeName': 'Howard C', 'Initials': 'HC', 'LastName': 'Dittrich', 'Affiliation': 'Cirius Therapeutics, Inc., San Diego, CA, USA.'}]",Journal of hepatology,['10.1016/j.jhep.2020.06.025'] 2643,32610246,Structure and process associated with the efficiency of intensive care units in low-resource settings: An analysis of the CHECKLIST-ICU trial database.,"PURPOSE Characteristics of structure and process impact ICU performance and the outcomes of critically ill patients. We sought to identify organizational characteristics associated with efficient ICUs in low-resource settings. MATERIALS AND METHODS This is a secondary analysis of a multicenter cluster-randomized clinical trial in Brazil (CHECKLIST-ICU). Efficient units were defined by standardized mortality ratio (SMR) and standardized resource use (SRU) lower than the overall medians and non-efficient otherwise. We used a regularized logistic regression model to evaluate associations between organizational factors and efficiency. RESULTS From 118 ICUs (13,635 patients), 47 units were considered efficient and 71 non-efficient. Efficient units presented lower incidence rates (median[IQR]) of central line-associated bloodstream infections (4.95[0.00-22.0] vs 6.29[0.00-25.6], p = .04), utilization rates of mechanical ventilation (0.41[0.07-0.73] vs 0.58[0.19-0.82], p < .001), central venous catheter (0.67[0.15-0.98] vs 0.78[0.33-0.98], p = .04), and indwelling urinary catheter (0.62[0.22-0.95] vs 0.76[0.32-0.98], p < .01) than non-efficient units. The reported active surveillance of ventilator-associated pneumonia (OR = 1.72; 95%CI, 1.16-2.57) and utilization of central venous catheters (OR = 1.94; 95%CI, 1.32-2.94) were associated with efficient ICUs. CONCLUSIONS In low-resource settings, active surveillance of nosocomial infections and the utilization of invasive devices were associated with efficiency, supporting the management and evaluation of performance indicators as a starting point for improvement in ICU.",2020,"The reported active surveillance of ventilator-associated pneumonia (OR = 1.72; 95%CI, 1.16-2.57) and utilization of central venous catheters (OR = 1.94; 95%CI, 1.32-2.94) were associated with efficient ICUs. ","['critically ill patients', 'low-resource settings', 'From 118 ICUs (13,635 patients']",[],"['utilization of central venous catheters', 'utilization rates of mechanical ventilation', 'central venous catheter', 'standardized mortality ratio (SMR) and standardized resource use (SRU', 'incidence rates (median[IQR]) of central line-associated bloodstream infections', 'indwelling urinary catheter']","[{'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C4517542', 'cui_str': '118'}]",[],"[{'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C1145640', 'cui_str': 'Central venous catheter'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C3161235', 'cui_str': 'CLABSI - central line associated bloodstream infection'}, {'cui': 'C0521197', 'cui_str': 'Indwelling urinary catheter'}]",,0.219858,"The reported active surveillance of ventilator-associated pneumonia (OR = 1.72; 95%CI, 1.16-2.57) and utilization of central venous catheters (OR = 1.94; 95%CI, 1.32-2.94) were associated with efficient ICUs. ","[{'ForeName': 'Leonardo S L', 'Initials': 'LSL', 'LastName': 'Bastos', 'Affiliation': 'Department of Industrial Engineering, Pontifical Catholic University of Rio de Janeiro (PUC-Rio), Rio de Janeiro, RJ, Brazil.'}, {'ForeName': 'Silvio', 'Initials': 'S', 'LastName': 'Hamacher', 'Affiliation': 'Department of Industrial Engineering, Pontifical Catholic University of Rio de Janeiro (PUC-Rio), Rio de Janeiro, RJ, Brazil.'}, {'ForeName': 'Fernando G', 'Initials': 'FG', 'LastName': 'Zampieri', 'Affiliation': ""Research Institute, Hospital do Coração (HCor), São Paulo, Brazil; D'Or Institute for Research and Education (IDOR), Rio de Janeiro, RJ, Brazil; Brazilian Research in Intensive Care Network (BRICNet), Brazil.""}, {'ForeName': 'Alexandre B', 'Initials': 'AB', 'LastName': 'Cavalcanti', 'Affiliation': 'Research Institute, Hospital do Coração (HCor), São Paulo, Brazil; Brazilian Research in Intensive Care Network (BRICNet), Brazil.'}, {'ForeName': 'Jorge I F', 'Initials': 'JIF', 'LastName': 'Salluh', 'Affiliation': ""D'Or Institute for Research and Education (IDOR), Rio de Janeiro, RJ, Brazil; Brazilian Research in Intensive Care Network (BRICNet), Brazil.""}, {'ForeName': 'Fernando A', 'Initials': 'FA', 'LastName': 'Bozza', 'Affiliation': ""D'Or Institute for Research and Education (IDOR), Rio de Janeiro, RJ, Brazil; Brazilian Research in Intensive Care Network (BRICNet), Brazil; Oswaldo Cruz Foundation (FIOCRUZ), Rio de Janeiro, RJ, Brazil. Electronic address: fernando.bozza@ini.fiocruz.br.""}]",Journal of critical care,['10.1016/j.jcrc.2020.06.008'] 2644,32610254,"Antioxidant cocktail following a high-sodium meal does not affect vascular function in young, healthy adult humans: a randomized controlled crossover trial.","Chronic high sodium intake is a risk factor for cardiovascular disease as it impairs vascular function through an increase in oxidative stress. The objective of this study was to investigate the acute effects of a high-sodium meal (HSM) and antioxidant (AO) cocktail on vascular function. We hypothesized that a HSM would impair endothelial function, and increase arterial stiffness and wave reflection, while ingestion of the AO cocktail would mitigate this response. Healthy adults ingested either an AO cocktail (vitamin C, E, alpha-lipoic acid) or placebo (PLA) followed by a HSM (1500 mg) in a randomized crossover blinded design. Blood pressure (BP), endothelial function (flow-mediated dilation; FMD) and measures of arterial stiffness (pulse wave velocity; PWV) and wave reflection (augmentation index; AIx) were made at baseline and 30, 60, 90, and 120 min after meal consumption. Forty-one participants (20M/21W; 24 ± 1 years; BMI 23.4 ± 0.4 kg/m 2 ) completed the study. Mean BP increased at 120 min relative to 60 min (60 min: 79 ± 1; 120 min: 81 ± 1 mmHg; time effect P = .01) but was not different between treatments (treatment × time interaction P = .32). AIx decreased from baseline (time effect P < .001) but was not different between treatments (treatment × time interaction P = .31). PWV (treatment × time interaction, P = .91) and FMD (treatment × time interaction P = .65) were also not different between treatments. In conclusion, a HSM does not acutely impair vascular function suggesting young healthy adults can withstand the acute impact of sodium on the vasculature and therefore, the AO cocktail is not necessary to mitigate the response.",2020,AIx decreased from baseline (time effect P < .001) but was not different between treatments (treatment × time interaction P = .31).,"['young healthy adults', 'young, healthy adult humans', 'Healthy adults ingested either an', 'Forty-one participants (20M/21W; 24 ± 1 years; BMI 23.4 ± 0.4 kg/m 2 ) completed the study']","['Antioxidant cocktail following a high-sodium meal', 'HSM', 'AO cocktail (vitamin C, E, alpha-lipoic acid) or placebo (PLA) followed by a HSM', 'high-sodium meal (HSM) and antioxidant (AO) cocktail']","['endothelial function', 'Mean BP', 'FMD', 'Blood pressure (BP), endothelial function (flow-mediated dilation; FMD) and measures of arterial stiffness (pulse wave velocity; PWV) and wave reflection (augmentation index; AIx', 'vascular function', 'PWV']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C4517655', 'cui_str': '23.4'}, {'cui': 'C4517457', 'cui_str': '0.4'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0678420', 'cui_str': 'Cocktail'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0595879', 'cui_str': 'Sodium high'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C0023791', 'cui_str': 'thioctic acid'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332282', 'cui_str': 'Following'}]","[{'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0016052', 'cui_str': 'Fibromuscular dysplasia'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0012359', 'cui_str': 'Dilatation'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0599949', 'cui_str': 'Arterial stiffness'}, {'cui': 'C3494431', 'cui_str': 'Pulse Wave Velocity'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0332509', 'cui_str': 'Increased size'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0999177', 'cui_str': 'Aix'}, {'cui': 'C0232337', 'cui_str': 'Vascular function'}]",,0.120549,AIx decreased from baseline (time effect P < .001) but was not different between treatments (treatment × time interaction P = .31).,"[{'ForeName': 'Katarina', 'Initials': 'K', 'LastName': 'Smiljanec', 'Affiliation': 'Department of Kinesiology and Applied Physiology, University of Delaware, Newark, DE. Electronic address: ksmilja@udel.edu.'}, {'ForeName': 'Alexis U', 'Initials': 'AU', 'LastName': 'Mbakwe', 'Affiliation': 'Department of Kinesiology and Applied Physiology, University of Delaware, Newark, DE. Electronic address: ambakwe@udel.edu.'}, {'ForeName': 'Macarena', 'Initials': 'M', 'LastName': 'Ramos-Gonzalez', 'Affiliation': 'Department of Kinesiology and Applied Physiology, University of Delaware, Newark, DE. Electronic address: macramos@udel.edu.'}, {'ForeName': 'Ryan T', 'Initials': 'RT', 'LastName': 'Pohlig', 'Affiliation': 'Biostatistics Core Facility, University of Delaware, STAR, Newark, DE. Electronic address: rpohlig@udel.edu.'}, {'ForeName': 'Shannon L', 'Initials': 'SL', 'LastName': 'Lennon', 'Affiliation': 'Department of Kinesiology and Applied Physiology, University of Delaware, Newark, DE. Electronic address: slennon@udel.edu.'}]","Nutrition research (New York, N.Y.)",['10.1016/j.nutres.2020.05.011'] 2645,32610257,Oral vitamin C treatment increases polymorphonuclear cell functions in type 2 diabetes mellitus patients with poor glycemic control.,"This study investigated the effect of vitamin C on polymorphonuclear (PMN) cell functions in type 2 diabetes mellitus patients with poor glycemic control. We hypothesized that oral vitamin C treatment improves PMN cell functions. Patients (14) received either a vitamin C (1000 mg/d) or placebo (anhydrous calcium hydrogen phosphate) tablet for 6 weeks and were subjected to a 6-week washout period followed by a 6-week treatment crossover period. Blood samples were collected at pretreatment and posttreatment for PMN cell functions (by flow cytometry) and plasma vitamin C concentration. Phagocytosis was examined by incubating whole blood samples with fluorescein isothiocyanate-labeled Staphylococcus aureus, and oxidative burst was simultaneously evaluated by adding hydroethidine. In comparison with placebo, vitamin C increased both PMN cell phagocytosis (pretreatment: placebo, 17.8% ± 1.6% and vitamin C, 19.0% ± 3.4%, P = .70; posttreatment: placebo, 16.6% ± 1.7% and vitamin C, 27.1% ± 2.9%, P = .005) and oxidative burst (pretreatment: placebo, 6.4% ± 0.8% and vitamin C, 7.1% ± 1.2%, P = .60; posttreatment: placebo, 6.9% ± 1.3% and vitamin C, 12.1% ± 1.6%, P = .02). The plasma vitamin C concentration was elevated after vitamin C treatment as compared with that before treatment (P < .001) and was higher than that observed in the placebo treatment group (P < .01). Plasma vitamin C concentration and PMN cell functions were not significantly different before both treatments. We conclude that the 6-week 1000-mg/d vitamin C increased PMN phagocytosis and oxidative burst in type 2 diabetes mellitus patients with poor glycemic control.",2020,The plasma vitamin C concentration was elevated after vitamin C treatment as compared with that before treatment (P < .001) and was higher than that observed in the placebo treatment group (P < .01).,['type 2 diabetes mellitus patients with poor glycemic control'],"['Oral vitamin C treatment', 'placebo, vitamin C', 'oral vitamin C', 'vitamin C', 'placebo (anhydrous calcium hydrogen phosphate) tablet', 'placebo']","['PMN cell functions', 'polymorphonuclear (PMN) cell functions', 'Plasma vitamin C concentration and PMN cell functions', 'Blood samples', 'PMN cell phagocytosis', 'oxidative burst', 'plasma vitamin C concentration', 'polymorphonuclear cell functions', 'PMN phagocytosis and oxidative burst']","[{'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0342299', 'cui_str': 'Poor glycemic control'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0108134', 'cui_str': 'Calcium phosphate dibasic'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}]","[{'cui': 'C0027950', 'cui_str': 'Polymorphonuclear leukocyte'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0031308', 'cui_str': 'Phagocytosis'}, {'cui': 'C0085416', 'cui_str': 'Oxidative Burst'}]",,0.155192,The plasma vitamin C concentration was elevated after vitamin C treatment as compared with that before treatment (P < .001) and was higher than that observed in the placebo treatment group (P < .01).,"[{'ForeName': 'Nisa', 'Initials': 'N', 'LastName': 'Chuangchot', 'Affiliation': 'Biomedical Sciences Program, Graduate School, Khon Kaen University, Khon Kaen 40002, Thailand; The Centre for Research and Development of Medical Diagnostic Laboratories (CMDL), Faculty of Associated Medical Sciences, Khon Kaen University, Khon Kaen 40002, Thailand; Exercise and Sport Sciences Development and Research Group, Khon Kaen University, Khon Kaen 40002, Thailand. Electronic address: nisachuang@kku.ac.th.'}, {'ForeName': 'Chongchira', 'Initials': 'C', 'LastName': 'Boonthongkaew', 'Affiliation': 'Biomedical Sciences Program, Graduate School, Khon Kaen University, Khon Kaen 40002, Thailand; Exercise and Sport Sciences Development and Research Group, Khon Kaen University, Khon Kaen 40002, Thailand. Electronic address: chongchira@kkumail.com.'}, {'ForeName': 'Wisitsak', 'Initials': 'W', 'LastName': 'Phoksawat', 'Affiliation': 'The Centre for Research and Development of Medical Diagnostic Laboratories (CMDL), Faculty of Associated Medical Sciences, Khon Kaen University, Khon Kaen 40002, Thailand; Graduate School, Khon Kaen University, Khon Kaen 40002, Thailand. Electronic address: wisitsakphok@kkumail.com.'}, {'ForeName': 'Amonrat', 'Initials': 'A', 'LastName': 'Jumnainsong', 'Affiliation': 'The Centre for Research and Development of Medical Diagnostic Laboratories (CMDL), Faculty of Associated Medical Sciences, Khon Kaen University, Khon Kaen 40002, Thailand; Department of Clinical Immunology and Transfusion Sciences, Faculty of Associated Medical Sciences, Khon Kaen University, Khon Kaen 40002, Thailand. Electronic address: amonrat@kku.ac.th.'}, {'ForeName': 'Chanvit', 'Initials': 'C', 'LastName': 'Leelayuwat', 'Affiliation': 'The Centre for Research and Development of Medical Diagnostic Laboratories (CMDL), Faculty of Associated Medical Sciences, Khon Kaen University, Khon Kaen 40002, Thailand; Department of Clinical Immunology and Transfusion Sciences, Faculty of Associated Medical Sciences, Khon Kaen University, Khon Kaen 40002, Thailand. Electronic address: chanvit@kku.ac.th.'}, {'ForeName': 'Naruemon', 'Initials': 'N', 'LastName': 'Leelayuwat', 'Affiliation': 'Exercise and Sport Sciences Development and Research Group, Khon Kaen University, Khon Kaen 40002, Thailand; Department of Physiology, Faculty of Medicine, Khon Kaen University, Khon Kaen 40002, Thailand. Electronic address: naruemon@kku.ac.th.'}]","Nutrition research (New York, N.Y.)",['10.1016/j.nutres.2020.05.010'] 2646,32610266,Total IN.PACT All-Subjects One-Year Analysis and Standard vs Broader Implications.,"Drug-coated balloons (DCBs) have been shown to be superior to percutaneous transluminal angioplasty (PTA) for symptomatic femoropopliteal disease in randomized clinical trials; however, their clinical effectiveness and safety in more complex disease is less defined. The study sought to conduct a patient-level pooled analysis of all prospective randomized and single-arm studies evaluating the safety and efficacy of IN.PACT Admiral DCB (Medtronic) worldwide and in patients with complex disease. Subjects were treated with either IN.PACT Admiral DCB (n = 1837) or PTA (n = 143). The primary endpoint was freedom from clinically driven target-lesion revascularization (CD-TLR) within 12 months. The primary safety composite endpoint was freedom from device- and procedure-related death through 30 days, and freedom from major target-limb amputation, clinically driven target-vessel revascularization, and thrombosis within 12 months. Subsequently, we examined ""real-life"" complex lesions in a subgroup analysis, with standard use defined as simple, single de novo lesions (n = 712) and broader use defined as bilateral or multiple lesions (n = 1125). DCB when compared with PTA had significantly higher rates of freedom from CD-TLR through 12 months (93.8% vs 80.2%, respectively; P<.001). The DCB group did note higher rates of mortality at 1 year (3.1% DCB vs 0.0% PTA; P=.03). Notably, the broader use group showed superiority over the PTA group for freedom from CD-TLR (91.7% vs 80.2%; P<.001). IN.PACT Admiral DCB showed clinical superiority to PTA in the largest patient-level pooled analysis. Additionally, despite more complex and challenging lesions, DCB was superior to PTA. However, further adequately powered randomized studies are needed to confirm these results.",2020,"The primary safety composite endpoint was freedom from device- and procedure-related death through 30 days, and freedom from major target-limb amputation, clinically driven target-vessel revascularization, and thrombosis within 12 months.",['patients with complex disease'],"['Drug-coated balloons (DCBs', 'DCB', 'percutaneous transluminal angioplasty (PTA', 'IN.PACT Admiral DCB', 'PTA', 'IN.PACT Admiral DCB (Medtronic']","['rates of mortality', 'freedom from clinically driven target-lesion revascularization (CD-TLR', 'freedom from device- and procedure-related death through 30 days, and freedom from major target-limb amputation, clinically driven target-vessel revascularization, and thrombosis within 12 months']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0453946', 'cui_str': 'Coat'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft'}, {'cui': 'C0000370', 'cui_str': ""3-3'dichlorobenzidine""}, {'cui': 'C2936666', 'cui_str': 'Percutaneous transluminal angioplasty'}, {'cui': 'C4521767', 'cui_str': 'US Military Commissioned Officer O10'}]","[{'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0014742', 'cui_str': 'Erythema multiforme'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0002689', 'cui_str': 'Amputation of limb'}, {'cui': 'C0449618', 'cui_str': 'Target vessel'}, {'cui': 'C0040053', 'cui_str': 'Thrombosis'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]",,0.106699,"The primary safety composite endpoint was freedom from device- and procedure-related death through 30 days, and freedom from major target-limb amputation, clinically driven target-vessel revascularization, and thrombosis within 12 months.","[{'ForeName': 'Daniel S', 'Initials': 'DS', 'LastName': 'Kobe', 'Affiliation': ''}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Jaff', 'Affiliation': ''}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Zeller', 'Affiliation': ''}, {'ForeName': 'Peter A', 'Initials': 'PA', 'LastName': 'Schneider', 'Affiliation': ''}, {'ForeName': 'Mehdi H', 'Initials': 'MH', 'LastName': 'Shishehbor', 'Affiliation': 'Case Western Reserve University School of Medicine, University Hospitals, 11100 Euclid Avenue, Lakeside 3rd Floor, Cleveland, OH 44106 USA. Mehdi.Shishehbor@UHhospitals.org.'}]",The Journal of invasive cardiology,[] 2647,32610330,Cold Therapy and the Effect on Pain and Physiological Parameters in Patients Recovering from Spine Surgery: A Randomized Prospective Study.,"BACKGROUND This study aimed to determine the effect of cold therapy (CT) on pain and physiological parameters after spine surgery. MATERIALS AND METHODS This study was a prospective, randomized controlled trial. Study participants were randomly assigned to either a control group or a CT group. The outcome measured was pain intensity rated by a numeric rating scale. Psychological outcome measures were considered secondary. RESULTS Thirty-eight patients in each group completed the study. No statistically significant difference was found between the pain scores of patients in the CT and those in the control group during the 24-h period following surgery (group: F = 0.01, p = 0.922). However, it was found that the pain scores of patients in the CT group were significantly lower than those in the control group during the 48-h period (group: F = 10.59, p = 0.002). CONCLUSION CT reduced pain scores during the 48-h period following spine surgery. Our findings support the use of CT as an adjuvant therapy in pain management.",2020,"No statistically significant difference was found between the pain scores of patients in the CT and those in the control group during the 24-h period following surgery (group: F = 0.01, p = 0.922).","['Patients Recovering from Spine Surgery', 'Thirty-eight patients in each group completed the study']","['cold therapy (CT', 'CT', 'Cold Therapy', 'control group or a CT']","['pain and physiological parameters', 'Pain and Physiological Parameters', 'pain scores', 'pain intensity rated by a numeric rating scale']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0521108', 'cui_str': 'Recovering from'}, {'cui': 'C0920347', 'cui_str': 'Procedure on spinal cord'}, {'cui': 'C0450361', 'cui_str': '38'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0010412', 'cui_str': 'Cold therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",38.0,0.0614872,"No statistically significant difference was found between the pain scores of patients in the CT and those in the control group during the 24-h period following surgery (group: F = 0.01, p = 0.922).","[{'ForeName': 'Yeşim', 'Initials': 'Y', 'LastName': 'Yaman Aktaş', 'Affiliation': 'Department of Surgical Nursing,Faculty of Health Sciences, Giresun University, Giresun, Turkey, yesimyaman28@hotmail.com.'}, {'ForeName': 'Hanife', 'Initials': 'H', 'LastName': 'Durgun', 'Affiliation': 'Department of Nursing, Faculty of Health Sciences, Ordu University, Ordu, Turkey.'}, {'ForeName': 'Reyhan', 'Initials': 'R', 'LastName': 'Durhan', 'Affiliation': 'Neuro-Surgery Clinic, Ordu Public Hospital, Ordu, Turkey.'}]",Complementary medicine research,['10.1159/000508029'] 2648,32604296,Planning Minimal Access Incisions in Resectioning Benign Parotid Tumors.,"BACKGROUND Traditional parotid surgery leaves visible submaxillary cicatrices, unaesthetic results from incisions, and a high incidence of postoperative complications. This study aimed to examine the feasibility of newly designed incisions for the removal of benign parotid lesions. METHODS The authors randomly assigned patients (n = 48) with benign parotid lesions admitted to our department from November 2016 to April 2019. In the study group, an aesthetic incision was designed through a preoperative examination combined with a medical history and physical examination. Half of the patients (n = 24) underwent surgery with the new incision design, while the patients in the control group (n = 24) received conventional surgery. The therapeutic effects and outcomes of the two groups were compared. RESULTS The postoperative complication rate of the study group (n = 6) was significantly lower than that of the control group (n = 15). Compared to conventional surgery, patients who received the hidden incisions had less total drainage volume, decreased length of incision, and fewer days of postoperative hospitalization (P < 0.05). On an average follow-up of 20 months, no recurrence was found in any patient. CONCLUSIONS Minimal access incisions, aided with loupe magnification, greatly improve the surgical safety, patient outcomes, and final scar appearance. The described technique is worth further study and utilization.",2020,"Compared to conventional surgery, patients who received the hidden incisions had less total drainage volume, decreased length of incision, and fewer days of postoperative hospitalization (P < 0.05).","['patients (n\u200a=\u200a48) with benign parotid lesions admitted to our department from November 2016 to April 2019', 'Resectioning Benign Parotid Tumors']","['conventional surgery', 'aesthetic incision', 'Planning Minimal Access Incisions']","['postoperative complication rate', 'total drainage volume, decreased length of incision, and fewer days of postoperative hospitalization', 'surgical safety, patient outcomes, and final scar appearance']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205183', 'cui_str': 'Benign'}, {'cui': 'C0030580', 'cui_str': 'Parotid gland structure'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0496857', 'cui_str': 'Benign neoplasm of parotid gland'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0014901', 'cui_str': 'Aesthetics'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0444454', 'cui_str': 'Access'}]","[{'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0205388', 'cui_str': 'Few'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0008767', 'cui_str': 'Scarring'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}]",,0.0289035,"Compared to conventional surgery, patients who received the hidden incisions had less total drainage volume, decreased length of incision, and fewer days of postoperative hospitalization (P < 0.05).","[{'ForeName': 'Boyu', 'Initials': 'B', 'LastName': 'Guan', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, School of Stomatology, China Medical University, Liaoning Provincial Key Laboratory of Oral Diseases, Shenyang, China.'}, {'ForeName': 'Xuexin', 'Initials': 'X', 'LastName': 'Tan', 'Affiliation': ''}, {'ForeName': 'Yuexiao', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'Zhijun', 'Initials': 'Z', 'LastName': 'Xie', 'Affiliation': ''}, {'ForeName': 'Sisi', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': ''}, {'ForeName': 'Changfu', 'Initials': 'C', 'LastName': 'Sun', 'Affiliation': ''}]",The Journal of craniofacial surgery,['10.1097/SCS.0000000000006640'] 2649,32604381,Omitting Routine Radiography of Traumatic Ankle Fractures After Initial 2-Week Follow-up Does Not Affect Outcomes: The WARRIOR Trial: A Multicenter Randomized Controlled Trial.,"BACKGROUND The clinical consequences of routine follow-up radiographs for patients with ankle fracture are unclear, and their usefulness is disputed. The purpose of the present study was to determine if routine radiographs made at weeks 6 and 12 can be omitted without compromising clinical outcomes. METHODS This multicenter randomized controlled trial with a noninferiority design included 246 patients with an ankle fracture, 153 (62%) of whom received operative treatment. At 6 and 12 weeks of follow-up, patients in the routine-care group (n = 128) received routine radiographs whereas patients in the reduced-imaging group (n = 118) did not. The primary outcome was the Olerud-Molander Ankle Score (OMAS). Secondary outcomes were the American Academy of Orthopaedic Surgeons (AAOS) foot and ankle questionnaire, health-related quality of life (HRQoL) as measured with the EuroQol-5 Dimensions-3 Levels (EQ-5D-3L) and Short Form-36 (SF-36), complications, pain, health perception, self-perceived recovery, the number of radiographs, and the indications for radiographs to be made. The outcomes were assessed at baseline and at 6, 12, 26, and 52 weeks of follow-up. Data were analyzed with use of mixed models. RESULTS Reduced imaging was noninferior compared with routine care in terms of OMAS scores (difference [β], -0.9; 95% confidence interval [CI], -6.2 to 4.4). AAOS scores, HRQoL, pain, health perception, and self-perceived recovery did not differ between groups. Patients in the reduced-imaging group received a median of 4 radiographs, whereas those in the routine-care group received a median of 5 radiographs (p < 0.05). The rates of complications were similar (27.1% [32 of 118] in the reduced-imaging group, compared with 22.7% [29 of 128] in the routine-care group, p = 0.42). The types of complications were also similar. CONCLUSIONS Implementation of a reduced-imaging protocol following an ankle fracture has no measurable negative effects on functional outcome, pain, and complication rates during the first year of follow-up. The number of follow-up radiographs can be reduced by implementing this protocol. LEVEL OF EVIDENCE Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.",2020,"The rates of complications were similar (27.1% [32 of 118] in the reduced-imaging group, compared with 22.7% [29 of 128] in the routine-care group, p = 0.42).","['patients with ankle fracture', '246 patients with an ankle fracture, 153 (62%) of whom received operative treatment', 'Traumatic Ankle Fractures']",['routine radiographs'],"['American Academy of Orthopaedic Surgeons (AAOS) foot and ankle questionnaire, health-related quality of life (HRQoL) as measured with the EuroQol-5 Dimensions-3 Levels (EQ-5D-3L) and Short Form-36 (SF-36), complications, pain, health perception, self-perceived recovery, the number of radiographs, and the indications for radiographs to be made', 'AAOS scores, HRQoL, pain, health perception, and self-perceived recovery', 'Olerud-Molander Ankle Score (OMAS', 'OMAS scores', 'functional outcome, pain, and complication rates', 'rates of complications']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0159877', 'cui_str': 'Fracture of ankle'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332663', 'cui_str': 'Traumatic'}]","[{'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C1306645', 'cui_str': 'Plain radiography'}]","[{'cui': 'C0000876', 'cui_str': 'Academies'}, {'cui': 'C0334891', 'cui_str': 'Orthopedic surgeon'}, {'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0003086', 'cui_str': 'Tarsus'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0456949', 'cui_str': 'Level 3'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C1306645', 'cui_str': 'Plain radiography'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",246.0,0.207996,"The rates of complications were similar (27.1% [32 of 118] in the reduced-imaging group, compared with 22.7% [29 of 128] in the routine-care group, p = 0.42).","[{'ForeName': 'P', 'Initials': 'P', 'LastName': 'van Gerven', 'Affiliation': 'Department of Trauma Surgery, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Krijnen', 'Affiliation': 'Department of Trauma Surgery, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'W P', 'Initials': 'WP', 'LastName': 'Zuidema', 'Affiliation': 'Department of Surgery, Amsterdam University Medical Center, Amsterdam, the Netherlands.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'El Moumni', 'Affiliation': 'Department of Surgery, University of Groningen, University Medical Center Groningen, Groningen, the Netherlands.'}, {'ForeName': 'S M', 'Initials': 'SM', 'LastName': 'Rubinstein', 'Affiliation': 'Amsterdam Movement Science Research Institute, Department of Health Sciences, VU University, Amsterdam, the Netherlands.'}, {'ForeName': 'M W', 'Initials': 'MW', 'LastName': 'van Tulder', 'Affiliation': 'Amsterdam Movement Science Research Institute, Department of Health Sciences, VU University, Amsterdam, the Netherlands.'}, {'ForeName': 'I B', 'Initials': 'IB', 'LastName': 'Schipper', 'Affiliation': 'Department of Trauma Surgery, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'M F', 'Initials': 'MF', 'LastName': 'Termaat', 'Affiliation': 'Department of Trauma Surgery, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Journal of bone and joint surgery. American volume,['10.2106/JBJS.19.01381'] 2650,32604397,Association of Polymorphism rs67920064 in ADAMTS9 Gene with Mandibular Retrognathism in a Chinese Population.,"BACKGROUND Mandibular retrognathism is a common oral and maxillofacial deformity that may cause a series of physical and psychological diseases. Many studies indicated that genetic factors play an important role in the occurrence of mandibular retrognathism. In this study, we assess the association between polymorphism rs67920064 in ADAMTS9 gene and mandibular retrognathism in a Chinese population. MATERIAL AND METHODS Sixty participants (20 to 45 y, mean age 32.79 y) were classified into Class I or mandibular retrognathism skeletal-facial profile groups in accordance with cephalometric parameters. Thirty patients with mandibular retrognathism were assigned to the subject group; the others were assigned to the control group. Cephalometric parameters including sella-nasion A point, SN point B, condylion-gnathion (Gn), and gonion-Gn were recorded. Saliva samples from these participants were collected and polymerase chain reaction-restriction fragment length polymorphism was used to distinguish different genotypes of the rs67920064 single nucleotide polymorphisms (SNPs).We evaluated the correlation between mandibular retrognathism and polymorphism rs67920064 in the ADAMTS9 gene. RESULTS The distribution of rs67920064 gene polymorphism in ADAMST9 gene conforms to Hardy-Weinberg equilibrium. The A point-nasion-B point angle of the participants with the GA genotype of the rs67920064 SNP showed significantly decreased values (P<0.05), but there was no difference in length of mandibular body. Beyond that, the chi-square test showed that the GA genotype of rs67920064 SNP was highly associated with mandibular retrognathism (P<0.05). CONCLUSIONS Our research shows that there is an association between polymorphism rs67920064 in the ADAMTS9 gene and mandibular retrognathism in the Chinese population. Individuals with the GA phenotype are more likely to have mandibular retrognathism.",2020,The distribution of rs67920064 gene polymorphism in ADAMST9 gene conforms to Hardy-Weinberg equilibrium.,"['mandibular retrognathism in a Chinese population', 'Sixty participants (20 to 45 y, mean age 32.79 y) were classified into Class I or mandibular retrognathism skeletal-facial profile groups in accordance with cephalometric parameters', 'Thirty patients with mandibular retrognathism', 'Gene with Mandibular Retrognathism in a Chinese Population']",['ADAMTS9'],"['length of mandibular body', 'Cephalometric parameters including sella-nasion A point, SN point B, condylion-gnathion (Gn), and gonion-Gn']","[{'cui': 'C0266077', 'cui_str': 'Mandibular retrognathism'}, {'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0441885', 'cui_str': 'Class 1'}, {'cui': 'C0037253', 'cui_str': 'Skeletal system structure'}, {'cui': 'C0424476', 'cui_str': 'Facial profile'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0017337', 'cui_str': 'Gene'}]","[{'cui': 'C1257533', 'cui_str': 'ADAM-TS9 protein, human'}]","[{'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0222746', 'cui_str': 'Structure of body of mandible'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C2924617', 'cui_str': 'Cephalometric nasion to a point line'}, {'cui': 'C2924613', 'cui_str': 'Cephalometric point B'}, {'cui': 'C3266676', 'cui_str': 'Cephalometric condylion point'}, {'cui': 'C1185651', 'cui_str': 'Cephalometric gonion point'}]",60.0,0.0312769,The distribution of rs67920064 gene polymorphism in ADAMST9 gene conforms to Hardy-Weinberg equilibrium.,"[{'ForeName': 'Chi', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, School and Hospital of Stomatology, Wenzhou Medical University, Wenzhou, Zhejiang, China (mainland).'}, {'ForeName': 'Zhenyu', 'Initials': 'Z', 'LastName': 'Ni', 'Affiliation': 'Department of Orthodontics, School and Hospital of Stomatology, Wenzhou Medical University, Wenzhou, Zhejiang, China (mainland).'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Cai', 'Affiliation': 'Department of Orthodontics, School and Hospital of Stomatology, Wenzhou Medical University, Wenzhou, Zhejiang, China (mainland).'}, {'ForeName': 'Yu', 'Initials': 'Y', 'LastName': 'Zhou', 'Affiliation': 'Department of Orthodontics, School and Hospital of Stomatology, Wenzhou Medical University, Wenzhou, Zhejiang, China (mainland).'}, {'ForeName': 'Weiting', 'Initials': 'W', 'LastName': 'Chen', 'Affiliation': 'Department of Orthodontics, School and Hospital of Stomatology, Wenzhou Medical University, Wenzhou, Zhejiang, China (mainland).'}]",Medical science monitor : international medical journal of experimental and clinical research,['10.12659/MSM.925965'] 2651,32604401,Using prefrontal transcranial direct current stimulation (tDCS) to enhance proactive cognitive control in schizophrenia.,"The goal of this study was to use transcranial direct current stimulation (tDCS) to examine the role of the prefrontal cortex (PFC) in neural oscillatory activity associated with proactive cognitive control in schizophrenia. To do so, we tested the impact of PFC-targeted tDCS on behavioral and electrophysiological markers of proactive cognitive control engagement in individuals with schizophrenia. Using a within-participants, double-blinded, sham-controlled crossover design, we recorded EEG while participants with schizophrenia completed a proactive cognitive control task (the Dot Pattern Expectancy (DPX) Task), after receiving 20 min of active prefrontal stimulation at 2 mA or sham stimulation. We hypothesized that active stimulation would enhance proactive cognitive control, leading to changes in behavioral performance on the DPX task and in activity in the gamma frequency band during key periods of the task designed to tax proactive cognitive control. The results showed significant changes in the pattern of error rates and increases in EEG gamma power as a function of tDCS condition (active or sham), that were indicative of enhanced proactive cognitive control. These findings, considered alongside our previous work in healthy adults, provides novel support for the role gamma oscillations in proactive cognitive control and they suggest that frontal tDCS may be a promising approach to enhance proactive cognitive control in schizophrenia.",2020,"The results showed significant changes in the pattern of error rates and increases in EEG gamma power as a function of tDCS condition (active or sham), that were indicative of enhanced proactive cognitive control.","['healthy adults', 'schizophrenia', 'individuals with schizophrenia', 'participants with schizophrenia completed a']","['transcranial direct current stimulation (tDCS', 'proactive cognitive control task (the Dot Pattern Expectancy (DPX) Task), after receiving 20\u2009min of active prefrontal stimulation at 2\u2009mA or sham stimulation', 'PFC-targeted tDCS', 'prefrontal transcranial direct current stimulation (tDCS']",['pattern of error rates and increases in EEG gamma power'],"[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1720485', 'cui_str': 'Corneal epithelial dots'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0679138', 'cui_str': 'Expectations'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0162783', 'cui_str': 'Prefrontal Cortex'}]","[{'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0017011', 'cui_str': 'Gamma radiation'}]",,0.0402734,"The results showed significant changes in the pattern of error rates and increases in EEG gamma power as a function of tDCS condition (active or sham), that were indicative of enhanced proactive cognitive control.","[{'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Boudewyn', 'Affiliation': 'University of California, Davis, CA, USA. maboudewyn@ucdavis.edu.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Scangos', 'Affiliation': 'University of California, San Francisco, CA, USA.'}, {'ForeName': 'Charan', 'Initials': 'C', 'LastName': 'Ranganath', 'Affiliation': 'University of California, Davis, CA, USA.'}, {'ForeName': 'Cameron S', 'Initials': 'CS', 'LastName': 'Carter', 'Affiliation': 'University of California, Davis, CA, USA.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-020-0750-8'] 2652,32604406,A Phase 2 Study of Pimodivir (JNJ-63623872) in Combination with Oseltamivir in Elderly and NonElderly Adults Hospitalized with Influenza A Infection: OPAL study.,"BACKGROUND Both the elderly and individuals with comorbidities are at increased risk of developing influenza-related complications. Novel influenza antivirals are required, given limitations of current drugs (eg, resistance emergence and poor efficacy). Pimodivir is a first-in-class antiviral for influenza A under development for these patients. METHODS Hospitalized patients with influenza A infection were randomized 2:1 to receive pimodivir 600 mg plus oseltamivir 75 mg or placebo plus oseltamivir 75 mg twice daily for 7 days in this phase 2b study. The primary objective was to compare pimodivir pharmacokinetics in elderly (aged 65-85 years) versus non-elderly adults (aged 18-64 years). Secondary endpoints included time-to-patient-reported symptom resolution. RESULTS Pimodivir pharmacokinetic parameters in non-elderly and elderly patients were similar. Time-to-influenza symptom resolution was numerically shorter with pimodivir (72.45 hours) than placebo (94.15 hours). There was a lower incidence of influenza-related complications in the pimodivir group (7.9%) versus placebo group (15.6%). Treatment was generally well tolerated. CONCLUSIONS No apparent relationship was observed between pimodivir pharmacokinetics and age. Our data demonstrate the need for a larger study of pimodivir in addition to oseltamivir to test whether it results in a clinically significant decrease in time-to-influenza symptom alleviation and/or the frequency of influenza complications.",2020,Time-to-influenza symptom resolution was numerically shorter with pimodivir (72.45 hours) than placebo (94.15 hours).,"['Elderly and NonElderly Adults Hospitalized with Influenza A Infection', 'elderly (aged 65-85 years) versus non-elderly adults (aged 18-64 years', 'Hospitalized patients with influenza A infection', 'non-elderly and elderly patients']","['Oseltamivir', 'pimodivir 600 mg plus oseltamivir 75 mg or placebo plus oseltamivir', 'placebo']","['tolerated', 'Time-to-influenza symptom resolution', 'influenza-related complications', 'pimodivir pharmacokinetics', 'time-to-patient-reported symptom resolution', 'time-to-influenza symptom alleviation']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C1615607', 'cui_str': 'Influenza A virus subtype H1N1'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0874161', 'cui_str': 'Oseltamivir'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C1126043', 'cui_str': 'Oseltamivir 75 MG'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0021400', 'cui_str': 'Influenza'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0684224', 'cui_str': 'Report'}]",,0.0349815,Time-to-influenza symptom resolution was numerically shorter with pimodivir (72.45 hours) than placebo (94.15 hours).,"[{'ForeName': 'Brian', 'Initials': 'B', 'LastName': ""O'Neil"", 'Affiliation': 'Wayne State University School of Medicine, Detroit Medical Center, Detroit, Michigan, USA.'}, {'ForeName': 'Michael G', 'Initials': 'MG', 'LastName': 'Ison', 'Affiliation': 'Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA.'}, {'ForeName': 'Marie-Charlotte', 'Initials': 'MC', 'LastName': 'Hallouin-Bernard', 'Affiliation': 'University Hospital of Tours, Tours, France.'}, {'ForeName': 'Anna C', 'Initials': 'AC', 'LastName': 'Nilsson', 'Affiliation': 'Infectious Disease Research Unit, Department of Translational Medicine, Skåne University Hospital, Malmö, Sweden.'}, {'ForeName': 'Antoni', 'Initials': 'A', 'LastName': 'Torres', 'Affiliation': 'Servei de Pneumologia Hospital Clinic, IDIBAPS, CIBERES, University of Barcelona, Barcelona, Spain.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Wilburn', 'Affiliation': 'Wayne State University School of Medicine, Detroit Medical Center, Detroit, Michigan, USA.'}, {'ForeName': 'Wilbert', 'Initials': 'W', 'LastName': 'van Duijnhoven', 'Affiliation': 'Janssen Pharmaceutica NV, Beerse, Belgium.'}, {'ForeName': 'Ilse', 'Initials': 'I', 'LastName': 'Van Dromme', 'Affiliation': 'Janssen Pharmaceutica NV, Beerse, Belgium.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Anderson', 'Affiliation': 'Janssen Research & Development, LLC, Titusville, New Jersey, USA.'}, {'ForeName': 'Sofie', 'Initials': 'S', 'LastName': 'Deleu', 'Affiliation': 'Janssen Pharmaceutica NV, Beerse, Belgium.'}, {'ForeName': 'Teddy', 'Initials': 'T', 'LastName': 'Kosoglou', 'Affiliation': 'Janssen Research & Development, LLC, Titusville, New Jersey, USA.'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Vingerhoets', 'Affiliation': 'Janssen Pharmaceutica NV, Beerse, Belgium.'}, {'ForeName': 'Stefaan', 'Initials': 'S', 'LastName': 'Rossenu', 'Affiliation': 'Janssen Pharmaceutica NV, Beerse, Belgium.'}, {'ForeName': 'Lorant', 'Initials': 'L', 'LastName': 'Leopold', 'Affiliation': 'Janssen Research & Development, LLC, Titusville, New Jersey, USA.'}]",The Journal of infectious diseases,['10.1093/infdis/jiaa376'] 2653,32604422,Digital Measurement of Individual Motor and Proprioceptive Skills in Patients with Osteoarthritis of the Knee Prior to Total Knee Replacement.,"PURPOSE In spite of consistent improvement in operative methods for total knee arthroplasty, individual motor deficits may lead to a lower outcome. The preoperative classification in individual motoric capacity may get more significance for the future. Complementary to established questionnaires and clinical tests, this pilot study should demonstrate that it is possible to generate a preoperative motor score using a force platform measurement (KMP). Compared to questionnaires the new score represents digital values suitable for everyday clinical use. METHODS In total 63 Patients were randomized selected on the day before a bicondylar total knee replacement. A mobile force platform KMP (Motosana) measured the parameter maximum force, power and balance. Fluctuation area was measured in mm² and fluctuation path in mm. One leg standing without holding, transient help or permanent holding at armrests were registered. The force (Newton) was measured while a modified cross lift exercise and power (Watt) by performing five squads. RESULTS Based on comprehensive statistical consolidated data of maximum force, power and balance it was possible to create a new motor score ""Knie Fit 1.0"". Depending on interindividual performance patients were divided into those with higher or lower results. Regarding to their individual motor proprioceptive capacity we could also graduate patients into 4 different groups for force/power and balance. In total 17 of 63 patients offered a complex motor deficit, but on the other hand 17 different patients showed superior results in all categories. CONCLUSION It is possible to measure the motor capacity of patients using the mobile force platform (KMP) in everyday clinical practice. Based on this data a new motor score ""KnieFit 1.0"" was generated and groups of patients with different insufficiencies were created. Further follow-up studies should proof and compare the pre- and postoperative outcome in this field. With ""KnieFit 1.0"" it may be possible to create an individual perioperative rehabilitation program for compensation of detected deficits.",2020,It is possible to measure the motor capacity of patients using the mobile force platform (KMP) in everyday clinical practice.,"['Patients with Osteoarthritis of the Knee Prior to Total Knee Replacement', 'In total 63 Patients']",['Digital Measurement of Individual Motor and Proprioceptive Skills'],['Fluctuation area'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0439810', 'cui_str': 'Total'}]","[{'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0231239', 'cui_str': 'Fluctuation'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}]",63.0,0.0229891,It is possible to measure the motor capacity of patients using the mobile force platform (KMP) in everyday clinical practice.,"[{'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Redelbach', 'Affiliation': 'Trauma Surgery - Orthopaedic Surgery, Friedrich Alexander University Erlangen Nuremberg, Erlangen.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Mahnke', 'Affiliation': 'Orthopaedic Surgery, Dr. Erler Hospital, Nuremberg.'}, {'ForeName': 'Jens O', 'Initials': 'JO', 'LastName': 'Anders', 'Affiliation': 'Trauma Surgery - Orthopaedic Surgery, Friedrich Alexander University Erlangen Nuremberg, Erlangen.'}]",Zeitschrift fur Orthopadie und Unfallchirurgie,['10.1055/a-1174-0946'] 2654,32604427,Association of Successful Ultrasound-Accelerated Catheter-Directed Thrombolysis with Postthrombotic Syndrome: A Post Hoc Analysis of the CAVA Trial.,"BACKGROUND The CAVA trial did not show the anticipated risk reduction for postthrombotic syndrome (PTS) after thrombus removal via additional ultrasound-accelerated catheter-directed thrombolysis (UACDT) in patients with acute iliofemoral deep vein thrombosis (IFDVT). Difficulties in achieving an effective degree of recanalization through thrombolysis may have influenced outcomes. We therefore assessed whether successful UACDT (restored patency ≥ 90%) did reduce the development of PTS. METHODS This CAVA trial post hoc analysis compared the proportion of PTS at 1-year follow-up between patients with successful UACDT and patients that received standard treatment only. In addition, clinical impact as well as determinants of successful thrombolysis were explored. RESULTS UACDT was initiated in 77 (50.7%) patients and considered successful in 41 (53.2%, interrater agreement κ  = 0.7, 95% confidence interval 0.47-0.83). PTS developed in 15/41 (36.6%) patients in the successful UACDT group versus 33/75 (44.0%) controls ( p  = 0.44). In this comparison, successful UACDT was associated with lower Venous Clinical Severity Score (3.50 ± 2.57 vs. 4.82 ± 2.74, p  = 0.02) and higher EuroQOL-5D (EQ-5D) scores (40.2 ± 36.4 vs. 23.4 ± 34.4, p  = 0.01). Compared with unsuccessful UACDT, successful UACDT was associated with a shorter symptom duration at inclusion ( p  = 0.05), and higher rates of performed adjunctive procedures ( p  < 0.001) and stent placement ( p  < 0.001). CONCLUSION Successful UACDT was not associated with a reduced proportion of PTS 1 year after acute IFDVT compared with patients receiving standard treatment alone. There was, however, a significant reduction in symptom severity and improvement of generic quality of life according to the EQ-5D. Better patient selection and optimization of treatment protocols are needed to assess the full potential of UACDT for the prevention of PTS. TRIAL REGISTRATION NUMBER ClinicalTrials.gov number, NCT00970619.",2020,Successful UACDT was not associated with a reduced proportion of PTS 1 year after acute IFDVT compared with patients receiving standard treatment alone.,"['patients with acute iliofemoral deep vein thrombosis (IFDVT', 'with Postthrombotic Syndrome']","['Successful Ultrasound-Accelerated Catheter-Directed Thrombolysis', 'thrombus removal via additional ultrasound-accelerated catheter-directed thrombolysis (UACDT']","['stent placement', 'Venous Clinical Severity Score', 'higher rates of performed adjunctive procedures', 'higher EuroQOL-5D (EQ-5D) scores', 'PTS', 'symptom severity and improvement of generic quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0340714', 'cui_str': 'Iliofemoral deep vein thrombosis'}, {'cui': 'C0032807', 'cui_str': 'Postthrombotic syndrome'}]","[{'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0085590', 'cui_str': 'Catheter'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0520997', 'cui_str': 'Thrombolysis'}, {'cui': 'C0015252', 'cui_str': 'Removal'}]","[{'cui': 'C0522776', 'cui_str': 'Placement of stent'}, {'cui': 'C0042449', 'cui_str': 'Venous structure'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0457451', 'cui_str': 'Severity score'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0032807', 'cui_str': 'Postthrombotic syndrome'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0085155', 'cui_str': 'Generic Drugs'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",,0.355072,Successful UACDT was not associated with a reduced proportion of PTS 1 year after acute IFDVT compared with patients receiving standard treatment alone.,"[{'ForeName': 'Pascale', 'Initials': 'P', 'LastName': 'Notten', 'Affiliation': 'Department of Vascular Surgery, Maastricht University Medical Centre, Maastricht, The Netherlands.'}, {'ForeName': 'Carsten W K P', 'Initials': 'CWKP', 'LastName': 'Arnoldussen', 'Affiliation': 'Department of Radiology and Nuclear Medicine, Maastricht University Medical Centre, Maastricht, The Netherlands.'}, {'ForeName': 'Rutger', 'Initials': 'R', 'LastName': 'Brans', 'Affiliation': 'Department of Radiology and Nuclear Medicine, Maastricht University Medical Centre, Maastricht, The Netherlands.'}, {'ForeName': 'André A E A', 'Initials': 'AAEA', 'LastName': 'de Smet', 'Affiliation': 'Department of Vascular Surgery, Maasstad Hospital, Rotterdam, The Netherlands.'}, {'ForeName': 'Lidwine W', 'Initials': 'LW', 'LastName': 'Tick', 'Affiliation': 'Department of Internal Medicine, Maxima Medical Centre, Eindhoven, The Netherlands.'}, {'ForeName': 'Marlène H W', 'Initials': 'MHW', 'LastName': 'van de Poel', 'Affiliation': 'Department of Internal Medicine, Laurentius Hospital, Roermond, The Netherlands.'}, {'ForeName': 'Otmar R M', 'Initials': 'ORM', 'LastName': 'Wikkeling', 'Affiliation': 'Department of Vascular Surgery, Nij Smellinghe Hospital, Drachten, The Netherlands.'}, {'ForeName': 'Louis-Jean', 'Initials': 'LJ', 'LastName': 'Vleming', 'Affiliation': 'Department of Internal Medicine, Haga Hospital, The Hague, The Netherlands.'}, {'ForeName': 'Ad', 'Initials': 'A', 'LastName': 'Koster', 'Affiliation': 'Department of Internal Medicine, VieCuri Medical Centre, Venlo, The Netherlands.'}, {'ForeName': 'Kon-Siong G', 'Initials': 'KG', 'LastName': 'Jie', 'Affiliation': 'Department of Internal Medicine, Zuyderland Medical Centre, Sittard, The Netherlands.'}, {'ForeName': 'Esther M G', 'Initials': 'EMG', 'LastName': 'Jacobs', 'Affiliation': 'Department of Internal Medicine, Elkerliek Hospital, Helmond, The Netherlands.'}, {'ForeName': 'Harm P', 'Initials': 'HP', 'LastName': 'Ebben', 'Affiliation': 'Department of Vascular Surgery, Amsterdam University Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'Nils', 'Initials': 'N', 'LastName': 'Planken', 'Affiliation': 'Department of Radiology and Nuclear Medicine, Amsterdam University Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'Hugo', 'Initials': 'H', 'LastName': 'Ten Cate', 'Affiliation': 'Cardiovascular Research Institute Maastricht (CARIM), School for Cardiovascular Diseases, Maastricht University Medical Centre, Maastricht, The Netherlands.'}, {'ForeName': 'Cees H A', 'Initials': 'CHA', 'LastName': 'Wittens', 'Affiliation': 'Department of Vascular Surgery, Maastricht University Medical Centre, Maastricht, The Netherlands.'}, {'ForeName': 'Arina J', 'Initials': 'AJ', 'LastName': 'Ten Cate-Hoek', 'Affiliation': 'Cardiovascular Research Institute Maastricht (CARIM), School for Cardiovascular Diseases, Maastricht University Medical Centre, Maastricht, The Netherlands.'}]",Thrombosis and haemostasis,['10.1055/s-0040-1713171'] 2655,32604430,"Music Therapy for Early Postoperative Pain, Anxiety, and Sleep in Patients after Mitral Valve Replacement.","BACKGROUND To investigate the effect of music therapy on early postoperative pain, anxiety, and sleep quality in patients after mechanical mitral valve replacement (MVR). METHODS A total of 222 patients undergoing mechanical MVR were divided into two groups: the music group and the control group. The patients in the music group received 30 minutes of music therapy every day, whereas the patients in the control group had 30 minutes of quiet time. The visual analogue scale (VAS) was used to evaluate the degree of pain, and the Self-Rating Anxiety Scale (SAS) was used to evaluate the degree of early postoperative anxiety. We also recorded the sleep duration of the patients and used the Verran and Snyder-Halpern (VSH) Sleep Scale to evaluate the sleep quality of the patients. RESULTS The VAS scores in the music group were significantly lower than those in the control group, and early postoperative anxiety in the music group was also significantly improved compared with that in the control group. The sleep duration in the music group was significantly greater than that in the control group. In the evaluation of sleep quality using the VSH Sleep Scale, the scores for sleep interruption, sleep length, sleep depth, degree of rest, and subjective sleep quality in the music group were significantly lower than those in the control group. CONCLUSIONS Music therapy can be an effective intervention to reduce early postoperative pain, relieve early postoperative anxiety, prolong sleep time, and improve the sleep quality of patients after mechanical MVR.",2020,"The VAS scores in the music group were significantly lower than those in the control group, and early postoperative anxiety in the music group was also significantly improved compared with that in the control group.","['222 patients undergoing mechanical MVR', 'Patients after Mitral Valve Replacement', 'patients after mechanical mitral valve replacement (MVR']","['30\u2009minutes of music therapy', 'control group had 30\u2009minutes of quiet time', 'Music Therapy', 'music therapy', 'Music therapy']","['degree of pain, and the Self-Rating Anxiety Scale (SAS', 'VSH Sleep Scale, the scores for sleep interruption, sleep length, sleep depth, degree of rest, and subjective sleep quality', 'early postoperative anxiety', 'sleep duration', 'visual analogue scale (VAS', 'Verran and Snyder-Halpern (VSH) Sleep Scale', 'early postoperative pain, relieve early postoperative anxiety, prolong sleep time', 'early postoperative pain, anxiety, and sleep quality', 'sleep quality', 'Early Postoperative Pain, Anxiety, and Sleep', 'VAS scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0026268', 'cui_str': 'Replacement of mitral valve'}]","[{'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0026868', 'cui_str': 'Music therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439654', 'cui_str': 'Quiet'}, {'cui': 'C0040223', 'cui_str': 'Time'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0332453', 'cui_str': 'Disruption'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0424574', 'cui_str': 'Duration of sleep'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0332303', 'cui_str': 'Relieved by'}, {'cui': 'C0234452', 'cui_str': 'Prolonged sleep'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}]",222.0,0.0232151,"The VAS scores in the music group were significantly lower than those in the control group, and early postoperative anxiety in the music group was also significantly improved compared with that in the control group.","[{'ForeName': 'Qi-Liang', 'Initials': 'QL', 'LastName': 'Zhang', 'Affiliation': 'Department of Cardiac Surgery, Fujian Maternity and Child Health Hospital, Affiliated Hospital of Fujian Medical University, Fuzhou, China.'}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Xu', 'Affiliation': 'Department of Cardiac Surgery, Fujian Maternity and Child Health Hospital, Affiliated Hospital of Fujian Medical University, Fuzhou, China.'}, {'ForeName': 'Shu-Ting', 'Initials': 'ST', 'LastName': 'Huang', 'Affiliation': 'Department of Cardiac Surgery, Fujian Maternity and Child Health Hospital, Affiliated Hospital of Fujian Medical University, Fuzhou, China.'}, {'ForeName': 'Ze-Wei', 'Initials': 'ZW', 'LastName': 'Lin', 'Affiliation': 'Department of Cardiac Surgery, Fujian Maternity and Child Health Hospital, Affiliated Hospital of Fujian Medical University, Fuzhou, China.'}, {'ForeName': 'Liang-Wan', 'Initials': 'LW', 'LastName': 'Chen', 'Affiliation': 'Department of Cardiovascular Surgery, Union Hospital, Fujian Medical University, Fuzhou, China.'}, {'ForeName': 'Hua', 'Initials': 'H', 'LastName': 'Cao', 'Affiliation': 'Department of Cardiac Surgery, Fujian Maternity and Child Health Hospital, Affiliated Hospital of Fujian Medical University, Fuzhou, China.'}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Chen', 'Affiliation': 'Department of Cardiac Surgery, Fujian Maternity and Child Health Hospital, Affiliated Hospital of Fujian Medical University, Fuzhou, China.'}]",The Thoracic and cardiovascular surgeon,['10.1055/s-0040-1713352'] 2656,32604436,The Effectiveness of Psycho-Educational and Cognitive-Behavioral Counseling on Female Sexual Dysfunction.,"INTRODUCTION Sexual function is a multidimensional phenomenon that is affected by many biological and psychological factors. Cognitive-behavioral sex therapies are among the most common nonpharmacological approaches to psychosexual problems. The purpose of the present study was to investigate the effectiveness of psychoeducational and cognitive-behavioral counseling on female sexual dysfunction. METHODS The present study was a clinical trial with intervention and control groups. The study population consisted of women referring to the general clinic of a governmental hospital in Iran. After completing the demographic questionnaire and Female Sexual Function Index (FSFI), those who obtained the cutoff score ≤ 28 were contacted and invited to participate in the study. Convenience sampling method was used and 35 subjects were randomly allocated for each group. Eight counseling sessions were held for the intervention group (two/week/1.5 hour). Post-test was taken from both groups after 1 month, and the results were statistically analyzed by PASW Statistics for Windows, Version 18 (SPSS Inc., Chicago, IL, USA). RESULTS The total mean scores of FSFI and the subscales of sexual desire, arousal, orgasm, and satisfaction were significantly higher in the intervention group than in the control group after the intervention. In addition, postintervention pain mean scores in the intervention group were significantly lower than in the control group ( p  < 0.05). CONCLUSION The results of the present study indicate that psychoeducational cognitive-behavioral counseling is effective in improving female sexual function. It is recommended to compare the effects of psychoeducational cognitive-behavioral counseling on sexual dysfunctions of couples and with a larger sample size in future research.",2020,"The total mean scores of FSFI and the subscales of sexual desire, arousal, orgasm, and satisfaction were significantly higher in the intervention group than in the control group after the intervention.","['35 subjects', 'Female Sexual Dysfunction', 'women referring to the general clinic of a governmental hospital in Iran', 'female sexual dysfunction']","['Psycho-Educational and Cognitive-Behavioral Counseling', 'psychoeducational and cognitive-behavioral counseling', 'psychoeducational cognitive-behavioral counseling']","['total mean scores of FSFI and the subscales of sexual desire, arousal, orgasm, and satisfaction', 'demographic questionnaire and Female Sexual Function Index (FSFI', 'PASW Statistics for Windows, Version 18 (SPSS Inc., Chicago, IL, USA', 'postintervention pain mean scores']","[{'cui': 'C1112442', 'cui_str': 'Female sexual dysfunction'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0022065', 'cui_str': 'Iran'}]","[{'cui': 'C4546207', 'cui_str': 'Behavioral counseling'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0278098', 'cui_str': 'Female sexual function'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0023618', 'cui_str': 'Libido'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0029260', 'cui_str': 'Sexual orgasm'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0600673', 'cui_str': 'Statistics'}, {'cui': 'C0557702', 'cui_str': 'Window'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0008044', 'cui_str': 'Chicago'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",35.0,0.0133763,"The total mean scores of FSFI and the subscales of sexual desire, arousal, orgasm, and satisfaction were significantly higher in the intervention group than in the control group after the intervention.","[{'ForeName': 'Firoozeh', 'Initials': 'F', 'LastName': 'Mirzaee', 'Affiliation': 'Razi Nursing and Midwifery Faculty, Kerman University of Medical Sciences, Kerman, Iran.'}, {'ForeName': 'Atefeh', 'Initials': 'A', 'LastName': 'Ahmadi', 'Affiliation': 'Razi Nursing and Midwifery Faculty, Kerman University of Medical Sciences, Kerman, Iran.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Zangiabadi', 'Affiliation': 'Razi Nursing and Midwifery Faculty, Kerman University of Medical Sciences, Kerman, Iran.'}, {'ForeName': 'Moghaddameh', 'Initials': 'M', 'LastName': 'Mirzaee', 'Affiliation': 'Department of Epidemiology and Biostatistics, School of Public Health, Kerman University of Medical Sciences, Kerman, Iran.'}]",Revista brasileira de ginecologia e obstetricia : revista da Federacao Brasileira das Sociedades de Ginecologia e Obstetricia,['10.1055/s-0040-1712483'] 2657,32604756,Assessing the Implementation of a Behavior Change Intervention: Process Evaluation of a Stepped-Wedge Cluster Randomized Controlled Trial for Newborn Health.,"Maternal and under five-year-old mortality rates have reduced in the last two decades globally due to concerted effort, yet newborn deaths remain unacceptably prevalent. Behavior change is an important component of interventions to address newborn health problems in low-income countries. In Cambodia, maternal and newborn mortality has markedly decreased, and continued improvements will allow the country to achieve further reduction in newborn morbidity. The results of an implementation study of the Newborn Care and Infection Control Initiative using process evaluation are presented to provide insight into the trial implementation and context of the program that may have contributed to intervention results. The study utilized a mixed method process to explore the context, mechanisms, and implementation of intervention components: training of village health support group volunteers to provide home visits, training of midwives on infection prevention and control around the perinatal period, counseling on newborn care, and provision of training materials for counseling and intervention. Implementation was evaluated through quantitative and qualitative data collection including surveys, observation, semi-structured interviews, focus groups, and visual media. Descriptive statistics summarized the quantitative data and thematic analysis was used to explore the qualitative data. The evaluation identified several factors that might have influenced the outcomes of the trial: continuity of health center staff communication, timing and ability to complete home visits, and training quality. Additional support for parents in the perinatal period, preferably provided at the community level, will contribute to further improvement in health outcomes for newborns in this area. Researchers in this context should consider mechanisms to improve the coordination of health facility staff counseling while providing support and resources to ensure home visits to families with newborns are made on time. Attention to staffing, training, and quality of newborn health interventions is critical in planning for the scaling-up of newborn health programming.",2020,"Maternal and under five-year-old mortality rates have reduced in the last two decades globally due to concerted effort, yet newborn deaths remain unacceptably prevalent.",['Newborn Health'],"['village health support group volunteers to provide home visits, training of midwives on infection prevention and control around the perinatal period, counseling on newborn care, and provision of training materials for counseling and intervention']",['newborn morbidity'],"[{'cui': 'C4042838', 'cui_str': 'Neonatal Health'}]","[{'cui': 'C0562518', 'cui_str': 'Village environment'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0036606', 'cui_str': 'Support Groups'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0020043', 'cui_str': 'Home visit'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0026083', 'cui_str': 'Professional midwife'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0033107', 'cui_str': 'prevention & control'}, {'cui': 'C0178795', 'cui_str': 'Perinatal period'}, {'cui': 'C0341618', 'cui_str': 'Counsel'}, {'cui': 'C0204792', 'cui_str': 'Routine care of newborn'}, {'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}]",,0.0147921,"Maternal and under five-year-old mortality rates have reduced in the last two decades globally due to concerted effort, yet newborn deaths remain unacceptably prevalent.","[{'ForeName': 'Alessandra N', 'Initials': 'AN', 'LastName': 'Bazzano', 'Affiliation': 'Department of Global Community Health and Behavioral Sciences, Tulane School Public Health and Tropical Medicine, New Orleans, 70112 LA, USA.'}, {'ForeName': 'Jeni A', 'Initials': 'JA', 'LastName': 'Stolow', 'Affiliation': 'Department of Global Community Health and Behavioral Sciences, Tulane School Public Health and Tropical Medicine, New Orleans, 70112 LA, USA.'}, {'ForeName': 'Ryan', 'Initials': 'R', 'LastName': 'Duggal', 'Affiliation': 'School of Medicine, Tulane University, New Orleans, 70112 LA, USA.'}, {'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Oberhelman', 'Affiliation': 'Department of Global Community Health and Behavioral Sciences, Tulane School Public Health and Tropical Medicine, New Orleans, 70112 LA, USA.'}, {'ForeName': 'Yaoyao', 'Initials': 'Y', 'LastName': 'Sun', 'Affiliation': 'Department of Global Community Health and Behavioral Sciences, Tulane School Public Health and Tropical Medicine, New Orleans, 70112 LA, USA.'}, {'ForeName': 'Chivorn', 'Initials': 'C', 'LastName': 'Var', 'Affiliation': 'Reproductive Health Association of Cambodia, Phnom Penh 905, Cambodia.'}]","Healthcare (Basel, Switzerland)",['10.3390/healthcare8020187'] 2658,32604809,Development and Evaluation of a Gatekeeper Training Program Regarding Anxiety about Radiation Health Effects Following a Nuclear Power Plant Accident: A Single-Arm Intervention Pilot Trial.,"After the Fukushima Daiichi Nuclear Power Plant accident in March 2011, residents perceived a radiation exposure risk. To address the concerns about radiation exposure and the subsequent effects on their health, we developed the gatekeeper training program for radiation health anxiety and mental health issues. The program consisted of a presentation and roleplay, with educational objectives to the increase knowledge and understanding around radiation health anxiety, alcoholism, depression, and suicide. Twenty-six counselors participated in the program as a single-arm intervention. To measure the outcomes, the subjects reported self-confidence when they counselled with residents with radiation health anxiety and other mental health issues. Comparing the answers to pre- and 2-month follow-up surveys, the confidence levels were higher after 2 months than at baseline, especially for the question ""How confident are you at supporting a resident with mental health issues?"", which showed the largest increase ( p < 0.001). Regarding radiation health anxiety the questions ""Can you communicate coping skills to a resident with radiation health anxiety?"" ( p = 0.007) and ""Can you refer a resident with radiation health anxiety to professionals who can cope appropriately?"" ( p = 0.016) showed significant increases in their confidence levels. This program could be useful for on-going health activities and future nuclear disasters.",2020,"Comparing the answers to pre- and 2-month follow-up surveys, the confidence levels were higher after 2 months than at baseline, especially for the question ""How confident are you at supporting a resident with mental health issues?"", which showed the largest increase ( p < 0.001).",['Twenty-six counselors participated in the program as a single-arm intervention'],['Gatekeeper Training Program'],[],"[{'cui': 'C0450349', 'cui_str': '26'}, {'cui': 'C1571885', 'cui_str': 'Professional counselor'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}]",[],26.0,0.0210648,"Comparing the answers to pre- and 2-month follow-up surveys, the confidence levels were higher after 2 months than at baseline, especially for the question ""How confident are you at supporting a resident with mental health issues?"", which showed the largest increase ( p < 0.001).","[{'ForeName': 'Masatsugu', 'Initials': 'M', 'LastName': 'Orui', 'Affiliation': 'Department of Public Health, School of Medicine, Fukushima Medical University, Fukushima 960-1295, Japan.'}, {'ForeName': 'Maiko', 'Initials': 'M', 'LastName': 'Fukasawa', 'Affiliation': 'Department of Mental Health, Graduate School of Medicine, The University of Tokyo, Tokyo 113-0033, Japan.'}, {'ForeName': 'Naoko', 'Initials': 'N', 'LastName': 'Horikoshi', 'Affiliation': 'Department of Public Health, School of Medicine, Fukushima Medical University, Fukushima 960-1295, Japan.'}, {'ForeName': 'Yuriko', 'Initials': 'Y', 'LastName': 'Suzuki', 'Affiliation': 'Department of Public Health, School of Medicine, Fukushima Medical University, Fukushima 960-1295, Japan.'}, {'ForeName': 'Norito', 'Initials': 'N', 'LastName': 'Kawakami', 'Affiliation': 'Department of Mental Health, Graduate School of Medicine, The University of Tokyo, Tokyo 113-0033, Japan.'}]",International journal of environmental research and public health,['10.3390/ijerph17124594'] 2659,32604939,"Effects of Manual Therapy on Fatigue, Pain, and Psychological Aspects in Women with Fibromyalgia.","Fibromyalgia is a condition characterised by chronic widespread muscle pain and fatigue, sleep disturbances, cognitive disorders, and mood disturbance. The purpose of this study was to determine the effectiveness of a manual therapy technique performed with moderate digital pressure in women with fibromyalgia ( n = 24). In this randomised, controlled trial, the participants were randomly assigned to the experimental group or placebo group. The experimental group was assisted with manual therapy sessions based on connective tissue massage, whereas the placebo group was ""treated"" with ultrasound sessions performed without conductive gel and with the machine turned off as the placebo. Fatigue severity scale (FSS), visual analogical scale (VAS), Pittsburgh sleep quality index (PSQI), and profile of mood states (POMS-29) were completed before and after the intervention. In the experimental group (manual therapy), significant results were obtained on a VAS scale, referring to the neck pain in patients with fibromyalgia ( p < 0.001). Correlations showed a relationship between fatigue and sleep variables ( R = 0.411; p = 0.046) and pain variables with the POMS anger-hostility subscale ( R = 0.436; p = 0.033). Although the size of the sample could be a limitation, the study concluded that the application of manual therapy in fibromyalgia patients performed with moderate pressure for 15 min on the posterior cervical musculature decreased the perception of pain, muscle fatigue, and the state of tension-anxiety.",2020,"In the experimental group (manual therapy), significant results were obtained on a VAS scale, referring to the neck pain in patients with fibromyalgia ( p < 0.001).","['Women with Fibromyalgia', 'fibromyalgia patients', 'women with fibromyalgia ( n = 24']","['Manual Therapy', 'manual therapy technique', 'placebo group was ""treated"" with ultrasound sessions performed without conductive gel and with the machine turned off as the placebo', 'placebo']","['VAS scale, referring to the neck pain', 'fatigue and sleep variables', 'pain variables with the POMS anger-hostility subscale', 'perception of pain, muscle fatigue, and the state of tension-anxiety', 'Fatigue, Pain, and Psychological Aspects', 'Fatigue severity scale (FSS), visual analogical scale (VAS), Pittsburgh sleep quality index (PSQI), and profile of mood states (POMS-29']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0016053', 'cui_str': 'Fibromyalgia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0454525', 'cui_str': 'Manual therapy'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0017243', 'cui_str': 'Gel'}, {'cui': 'C0336779', 'cui_str': 'Machine'}, {'cui': 'C0541749', 'cui_str': 'Does turn'}]","[{'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0007859', 'cui_str': 'Neck pain'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0451394', 'cui_str': 'Profile of mood states'}, {'cui': 'C0002957', 'cui_str': 'Feeling angry'}, {'cui': 'C0020039', 'cui_str': 'Hostile behavior'}, {'cui': 'C3714605', 'cui_str': 'Pain sensation, function'}, {'cui': 'C0242979', 'cui_str': 'Muscle fatigue'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0233494', 'cui_str': 'Tension'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}]",,0.0398758,"In the experimental group (manual therapy), significant results were obtained on a VAS scale, referring to the neck pain in patients with fibromyalgia ( p < 0.001).","[{'ForeName': 'Yolanda', 'Initials': 'Y', 'LastName': 'Nadal-Nicolás', 'Affiliation': 'Faculty of Medicine, Miguel Hernández University of Elche, 03202 Elche, Spain.'}, {'ForeName': 'Jacobo Ángel', 'Initials': 'JÁ', 'LastName': 'Rubio-Arias', 'Affiliation': 'Department of Health and Human Performance, Faculty of Physical Activity and Sport Science, Polytechnic University of Madrid, 28040 Madrid, Spain.'}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'Martínez-Olcina', 'Affiliation': 'Faculty of Health Sciences, University of Alicante, 03690 Alicante, Spain.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Reche-García', 'Affiliation': 'Faculty of Nursing, Catholic University of Murcia, 30107 Murcia, Spain.'}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'Hernández-García', 'Affiliation': 'Faculty of Health Sciences, University of Alicante, 03690 Alicante, Spain.'}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Martínez-Rodríguez', 'Affiliation': 'Faculty of Sciences, Department of Analytical Chemistry, Nutrition and Food Sciences, University of Alicante, 03690 Alicante, Spain.'}]",International journal of environmental research and public health,['10.3390/ijerph17124611'] 2660,32605106,Hemodynamic Adaptations Induced by Short-Term Run Interval Training in College Students.,"Perceived lack of time is one of the most often cited barriers to exercise participation. High intensity interval training has become a popular training modality that incorporates intervals of maximal and low-intensity exercise with a time commitment usually shorter than 30 min. The purpose of this study was to examine the effects of short-term run interval training (RIT) on body composition (BC) and cardiorespiratory responses in undergraduate college students. Nineteen males (21.5 ± 1.6 years) were randomly assigned to a non-exercise control (CON, n = 10) or RIT ( n = 9). Baseline measurements of systolic and diastolic blood pressure, resting heart rate (HRrest), double product (DP) and BC were obtained from both groups. VO 2max and running speed associated with VO 2peak (sVO 2peak ) were then measured. RIT consisted of three running treadmill sessions per week over 4 weeks (intervals at 100% sVO 2peak , recovery periods at 40% sVO 2peak ). There were no differences in post-training BC or VO 2 max between groups ( p > 0.05). HRrest ( p = 0.006) and DP ( p ≤ 0.001) were lower in the RIT group compared to CON at completion of the study. RIT lowered HRrest and DP in the absence of appreciable BC and VO 2max changes. Thereby, RIT could be an alternative model of training to diminish health-related risk factors in undergraduate college students.",2020,HRrest ( p = 0.006) and DP ( p ≤ 0.001) were lower in the RIT group compared to CON at completion of the study.,"['undergraduate college students', 'College Students', 'Nineteen males (21.5 ± 1.6 years']","['non-exercise control (CON, n = 10) or RIT', 'Short-Term Run Interval Training', 'High intensity interval training', 'short-term run interval training (RIT']","['body composition (BC) and cardiorespiratory responses', 'VO 2max and running speed associated with VO 2peak (sVO 2peak ', 'systolic and diastolic blood pressure, resting heart rate (HRrest), double product (DP) and BC']","[{'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0450337', 'cui_str': '19'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C4517508', 'cui_str': '1.6'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}]","[{'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C1821417', 'cui_str': 'Resting heart rate'}, {'cui': 'C0205173', 'cui_str': 'Double'}]",3.0,0.0570308,HRrest ( p = 0.006) and DP ( p ≤ 0.001) were lower in the RIT group compared to CON at completion of the study.,"[{'ForeName': 'Patricia C', 'Initials': 'PC', 'LastName': 'García-Suárez', 'Affiliation': 'Facultad de Deportes, Universidad Autónoma de Baja California-Ensenada, Boulevard Zertuche s/n. Fraccionamiento Valle Dorado, Ensenada 22890, Baja California, Mexico.'}, {'ForeName': 'Iván', 'Initials': 'I', 'LastName': 'Rentería', 'Affiliation': 'Facultad de Deportes, Universidad Autónoma de Baja California-Ensenada, Boulevard Zertuche s/n. Fraccionamiento Valle Dorado, Ensenada 22890, Baja California, Mexico.'}, {'ForeName': 'Priscilla', 'Initials': 'P', 'LastName': 'García Wong-Avilés', 'Affiliation': 'Facultad de Deportes, Universidad Autónoma de Baja California-Ensenada, Boulevard Zertuche s/n. Fraccionamiento Valle Dorado, Ensenada 22890, Baja California, Mexico.'}, {'ForeName': 'Fernanda', 'Initials': 'F', 'LastName': 'Franco-Redona', 'Affiliation': 'Facultad de Deportes, Universidad Autónoma de Baja California-Ensenada, Boulevard Zertuche s/n. Fraccionamiento Valle Dorado, Ensenada 22890, Baja California, Mexico.'}, {'ForeName': 'Luis M', 'Initials': 'LM', 'LastName': 'Gómez-Miranda', 'Affiliation': 'Facultad de Deportes Tijuana, Universidad Autónoma de Baja California, Avenida Maclovio Herrera #4080, Colonia Francisco Villa, Tijuana 22615, Baja California, Mexico.'}, {'ForeName': 'Jorge A', 'Initials': 'JA', 'LastName': 'Aburto-Corona', 'Affiliation': 'Facultad de Deportes Tijuana, Universidad Autónoma de Baja California, Avenida Maclovio Herrera #4080, Colonia Francisco Villa, Tijuana 22615, Baja California, Mexico.'}, {'ForeName': 'Eric P', 'Initials': 'EP', 'LastName': 'Plaisance', 'Affiliation': 'Department of Human Studies, University of Alabama at Birmingham, Education Building 901, 13th Street South, Birmingham, AL 35294, USA.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Moncada-Jiménez', 'Affiliation': 'Human Movement Sciences Research Center (CIMOHU), University of Costa Rica, Ave. 31 Pavas, San José 1200, Costa Rica.'}, {'ForeName': 'Alberto', 'Initials': 'A', 'LastName': 'Jiménez-Maldonado', 'Affiliation': 'Facultad de Deportes, Universidad Autónoma de Baja California-Ensenada, Boulevard Zertuche s/n. Fraccionamiento Valle Dorado, Ensenada 22890, Baja California, Mexico.'}]",International journal of environmental research and public health,['10.3390/ijerph17134636'] 2661,32605121,Effects of Plyometric and Repeated Sprint Training on Physical Performance.,"The purpose of study was to resolve the effect of plyometric training and repeated sprint training on physical performance. The study was conducted on 41 subjects in two experimental groups (plyometric/repeated sprints training). Before and after the training program, subjects were subjected to diagnostic procedures that included standard test protocols. Results proved a statistically significant difference only after the plyometric training program compared to the repeated sprint group in countermovement jump (8.65% vs. 2.21%). In variable repeated jumps, an increased value was recorded (2.9% vs. 4.29%), like in sprint variables after the training program where certain trends of progress happened after the repeated sprint ability training and the specificity of the program (5 m = 0.89%, 10 m = 1.07% and 25 m = 1.35%), while plyometric training recorded unchanged values at 5 and 10 m, and a 0.27% improvement at 25 m. Stagnation of the 20-yard test was recorded in both groups. There was no difference between training programs in any variables of functional capacities, with similar measures recorded in repeated sprint ability. After six weeks of both training types, positive changes can be expected in explosive strength of lower extremities, increases in acceleration area, and maximum speed.",2020,"There was no difference between training programs in any variables of functional capacities, with similar measures recorded in repeated sprint ability.",['41 subjects in two experimental groups (plyometric/repeated sprints training'],"['Plyometric and Repeated Sprint Training', 'plyometric training and repeated sprint training']","['Physical Performance', 'explosive strength of lower extremities, increases in acceleration area, and maximum speed', 'physical performance']","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0454374', 'cui_str': 'Sprint training'}]","[{'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0454374', 'cui_str': 'Sprint training'}, {'cui': 'C3178799', 'cui_str': 'Plyometric Drill'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0015330', 'cui_str': 'Explosive device'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0000894', 'cui_str': 'Acceleration'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}]",41.0,0.0169028,"There was no difference between training programs in any variables of functional capacities, with similar measures recorded in repeated sprint ability.","[{'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Krakan', 'Affiliation': 'Faculty of Kinesiology, University of Zagreb, 10.000 Zagreb, Croatia.'}, {'ForeName': 'Luka', 'Initials': 'L', 'LastName': 'Milanovic', 'Affiliation': 'Faculty of Kinesiology, University of Zagreb, 10.000 Zagreb, Croatia.'}, {'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Belcic', 'Affiliation': 'Faculty of Kinesiology, University of Zagreb, 10.000 Zagreb, Croatia.'}]","Sports (Basel, Switzerland)",['10.3390/sports8070091'] 2662,32605142,"Outcomes Assessment of Sustainable and Innovatively Simple Lifestyle Modification at the Workplace - Drinking Electrolyzed-Reduced Water (OASIS-ERW): A Randomized, Double-Blind, Placebo-Controlled Trial.","Oxidative stress has been associated with many diseases as well as aging. Electrolyzed-reduced water (ERW) has been suggested to reduce oxidative stress and improve antioxidant potential. This study investigated the effects of drinking ERW on biomarkers of oxidative stress and health-related indices in healthy adults. We conducted a randomized, double-blind, placebo-controlled clinical trial on 65 participants, who were allocated into two groups. Of these, 61 received intervention (32 with ERW and 29 MW [mineral water]). All participants were instructed to drink 1.5 L/day of ERW or MW for eight weeks. Biomarkers of oxidative stress and health-related indices were assessed at baseline as well as after 4 weeks and 8 weeks of intervention. Of the primary outcome variables assessed, diacron-reactive oxygen metabolites (d-ROMs) and biological antioxidant potential showed a significant interaction between the groups and time, with d-ROMs levels significantly decreased at 8 weeks in ERW compared to those in MW. Among the secondary outcome variables, total, visceral, and subcutaneous fat mass significantly changed over time, with a significant association observed between the groups and time. Thus, daily ERW consumption may be a potential consideration for a sustainable and innovatively simple lifestyle modification at the workplace to reduce oxidative stress, increase antioxidant potential, and decrease fat mass.",2020,"Among the secondary outcome variables, total, visceral, and subcutaneous fat mass significantly changed over time, with a significant association observed between the groups and time.","['healthy adults', '65 participants']","['Placebo', 'Electrolyzed-reduced water (ERW', 'drinking ERW', 'Sustainable and Innovatively Simple Lifestyle Modification at the Workplace - Drinking Electrolyzed-Reduced Water (OASIS-ERW', 'placebo']","['total, visceral, and subcutaneous fat mass', 'diacron-reactive oxygen metabolites (d-ROMs) and biological antioxidant potential showed a significant interaction between the groups and time, with d-ROMs levels']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0205352', 'cui_str': 'Simple'}, {'cui': 'C0023676', 'cui_str': 'Life style'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0162579', 'cui_str': 'Work environment'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0766345', 'cui_str': 'OASIS'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0442045', 'cui_str': 'Visceral'}, {'cui': 'C0222331', 'cui_str': 'Subcutaneous fatty tissue'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0205332', 'cui_str': 'Reactive'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C4049351', 'cui_str': 'Biological antioxidant potential'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0021797', 'cui_str': 'Interpersonal Relations'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",65.0,0.311292,"Among the secondary outcome variables, total, visceral, and subcutaneous fat mass significantly changed over time, with a significant association observed between the groups and time.","[{'ForeName': 'Young Ah', 'Initials': 'YA', 'LastName': 'Choi', 'Affiliation': 'Department of Family Medicine, Bundang Jesaeng General Hospital, Seongnam-si, Gyeonggi-do 13590, Korea.'}, {'ForeName': 'Dong Hyeon', 'Initials': 'DH', 'LastName': 'Lee', 'Affiliation': 'Department of Physiology, School of Medicine, CHA University, Seongnam-si, Gyeonggi-do 13488, Korea.'}, {'ForeName': 'Doo-Yeoun', 'Initials': 'DY', 'LastName': 'Cho', 'Affiliation': 'Department of Clinical Pharmacology, School of Medicine, CHA University, Seongnam-si, Gyeonggi-do 13496, Korea.'}, {'ForeName': 'Yong-Jae', 'Initials': 'YJ', 'LastName': 'Lee', 'Affiliation': 'Department of Family Medicine, Yonsei University College of Medicine, Seoul 06273, Korea.'}]","Antioxidants (Basel, Switzerland)",['10.3390/antiox9070564'] 2663,32610451,"Ultra-Performance Liquid Chromatography-Ion Mobility Separation-Quadruple Time-of-Flight MS (UHPLC-IMS-QTOF MS) Metabolomics for Short-Term Biomarker Discovery of Orange Intake: A Randomized, Controlled Crossover Study.","A major problem with dietary assessments is their subjective nature. Untargeted metabolomics and new technologies can shed light on this issue and provide a more complete picture of dietary intake by measuring the profile of metabolites in biological samples. Oranges are one of the most consumed fruits in the world, and therefore one of the most studied for their properties. The aim of this work was the application of untargeted metabolomics approach with the novel combination of ion mobility separation coupled to high resolution mass spectrometry (IMS-HRMS) and study the advantages that this technique can bring to the area of dietary biomarker discovery, with the specific case of biomarkers associated with orange consumption ( Citrus reticulata ) in plasma samples taken during an acute intervention study (consisting of a randomized, controlled crossover trial in healthy individuals). A total of six markers of acute orange consumption, including betonicines and conjugated flavonoids, were identified with the experimental data and previous literature, demonstrating the advantages of ion mobility in the identification of dietary biomarkers and the benefits that an additional structural descriptor, as the collision cross section value (CCS), can provide in this area.",2020,"A total of six markers of acute orange consumption, including betonicines and conjugated flavonoids, were identified with the experimental data and previous literature, demonstrating the advantages of ion mobility in the identification of dietary biomarkers and the benefits that an additional structural descriptor, as the collision cross section value (CCS), can provide in this area.","['Orange Intake', 'healthy individuals']",['Ultra-Performance Liquid Chromatography-Ion Mobility Separation-Quadruple Time-of-Flight MS (UHPLC-IMS-QTOF MS) Metabolomics'],[],"[{'cui': 'C0440277', 'cui_str': 'Orange - fruit'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0008565', 'cui_str': 'Liquid chromatography measurement'}, {'cui': 'C0022023', 'cui_str': 'Ions'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0036679', 'cui_str': 'Separation'}, {'cui': 'C0205175', 'cui_str': 'Quadruple'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1328813', 'cui_str': 'Metabolomics'}]",[],,0.0369513,"A total of six markers of acute orange consumption, including betonicines and conjugated flavonoids, were identified with the experimental data and previous literature, demonstrating the advantages of ion mobility in the identification of dietary biomarkers and the benefits that an additional structural descriptor, as the collision cross section value (CCS), can provide in this area.","[{'ForeName': 'Leticia', 'Initials': 'L', 'LastName': 'Lacalle-Bergeron', 'Affiliation': 'Research Institute for Pesticides and Water (IUPA), Universitat Jaume I, 12071 Castellón, Spain.'}, {'ForeName': 'Tania', 'Initials': 'T', 'LastName': 'Portolés', 'Affiliation': 'Research Institute for Pesticides and Water (IUPA), Universitat Jaume I, 12071 Castellón, Spain.'}, {'ForeName': 'Francisco J', 'Initials': 'FJ', 'LastName': 'López', 'Affiliation': 'Research Institute for Pesticides and Water (IUPA), Universitat Jaume I, 12071 Castellón, Spain.'}, {'ForeName': 'Juan Vicente', 'Initials': 'JV', 'LastName': 'Sancho', 'Affiliation': 'Research Institute for Pesticides and Water (IUPA), Universitat Jaume I, 12071 Castellón, Spain.'}, {'ForeName': 'Carolina', 'Initials': 'C', 'LastName': 'Ortega-Azorín', 'Affiliation': 'Department of Preventive Medicine and Public Health, School of Medicine, University of Valencia, 46010 Valencia, Spain.'}, {'ForeName': 'Eva M', 'Initials': 'EM', 'LastName': 'Asensio', 'Affiliation': 'Department of Preventive Medicine and Public Health, School of Medicine, University of Valencia, 46010 Valencia, Spain.'}, {'ForeName': 'Oscar', 'Initials': 'O', 'LastName': 'Coltell', 'Affiliation': 'CIBER Fisiopatología de la Obesidad y Nutrición (CIBEROBN), Instituto de Salud Carlos III, 28029 Madrid, Spain.'}, {'ForeName': 'Dolores', 'Initials': 'D', 'LastName': 'Corella', 'Affiliation': 'Department of Preventive Medicine and Public Health, School of Medicine, University of Valencia, 46010 Valencia, Spain.'}]",Nutrients,['10.3390/nu12071916'] 2664,32610465,Effects of Daily Probiotics Supplementation on Anxiety Induced Physiological Parameters among Competitive Football Players.,"Competitive football players who undergo strenuous training and frequent competitions are more vulnerable to psychological disorders. Probiotics are capable of reducing these psychological disorders. The present study aimed to determine the effect of daily probiotics supplementation on anxiety induced physiological parameters among competitive football players. The randomized, double-blinded, placebo-controlled trial was conducted on 20 male footballers who received either probiotics ( Lactobacillus Casei Shirota strain 3 × 10 10 colony forming units (CFU) or a placebo drink over eight weeks. Portable biofeedback devices were used to measure the electroencephalography, heart rate, and electrodermal responses along with cognitive tests at the baseline, week 4, and week 8. Data were statistically analyzed using mixed factorial ANOVA and results revealed that there is no significant difference between the probiotic and placebo groups for heart rate (61.90 bpm ± 5.84 vs. 67.67 bpm ± 8.42, p = 0.09) and electrodermal responses (0.27 µS ± 0.19 vs. 0.41 µS ± 0.12, p = 0.07) after eight weeks. Similarly, brain waves showed no significant changes during the study period except for the theta wave and delta wave at week 4 ( p < 0.05). The cognitive test reaction time (digit vigilance test) showed significant improvement in the probiotic group compared to the placebo ( p < 0.05). In conclusion, these findings suggest that daily probiotics supplementation may have the potential to modulate the brain waves namely, theta (relaxation) and delta (attention) for better training, brain function, and psychological improvement to exercise. Further research is needed to elucidate the mechanism of current findings.",2020,The cognitive test reaction time (digit vigilance test) showed significant improvement in the probiotic group compared to the placebo ( p < 0.05).,"['Competitive Football Players', 'competitive football players', '20 male footballers who received either']","['daily probiotics supplementation', 'Daily Probiotics Supplementation', 'probiotics ( Lactobacillus Casei Shirota strain 3 × 10 10 colony forming units (CFU) or a placebo drink', 'placebo']","['electrodermal responses', 'cognitive test reaction time (digit vigilance test', 'electroencephalography, heart rate, and electrodermal responses', 'heart rate']","[{'cui': 'C0016517', 'cui_str': 'American or Canadian football - sport'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0022940', 'cui_str': 'Lactobacillus casei'}, {'cui': 'C0080194', 'cui_str': 'Muscle strain'}, {'cui': 'C0439158', 'cui_str': 'colonies'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0452428', 'cui_str': 'Drink'}]","[{'cui': 'C0016989', 'cui_str': 'Galvanic skin response'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0582802', 'cui_str': 'Digit structure'}, {'cui': 'C0043012', 'cui_str': 'Wakefulness'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}]",20.0,0.177127,The cognitive test reaction time (digit vigilance test) showed significant improvement in the probiotic group compared to the placebo ( p < 0.05).,"[{'ForeName': 'A M G C P', 'Initials': 'AMGCP', 'LastName': 'Adikari', 'Affiliation': 'Sports Science Programme, Faculty of Sports Science and Recreation, Universiti Teknologi MARA, Shah Alam, Selangor 40450, Malaysia.'}, {'ForeName': 'Mahenderan', 'Initials': 'M', 'LastName': 'Appukutty', 'Affiliation': 'Sports Science Programme, Faculty of Sports Science and Recreation, Universiti Teknologi MARA, Shah Alam, Selangor 40450, Malaysia.'}, {'ForeName': 'Garry', 'Initials': 'G', 'LastName': 'Kuan', 'Affiliation': 'Exercise and Sport Science Programme, School of Health Sciences, Universiti Sains Malaysia, Kubang Kerian Kelantan 16150, Malaysia.'}]",Nutrients,['10.3390/nu12071920'] 2665,32610481,"Caffeine-Containing, Adaptogenic-Rich Drink Modulates the Effects of Caffeine on Mental Performance and Cognitive Parameters: A Double-Blinded, Placebo-Controlled, Randomized Trial.","Using a placebo-controlled, double-blinded, within-participants, randomized, cross-over design, we examined the neurocognitive effects of a: (a) caffeine-containing, adaptogenic herbal-rich natural energy shot (e+ shot), (b) a matched caffeine-containing shot (caffeine), and, (c) a placebo. Participants ( n = 30) were low consumers of caffeine without elevated feelings of energy. Before and three times after beverage consumption, a 27-min battery was used to assess motivation to perform cognitive tasks, mood, attention ((serial subtractions of 3 (SS3) and 7 (SS7), the continuous performance task (CPT), and the rapid visual input processing tasks)), heart rate (HR), blood pressure (BP), and motor coordination (nine-hole peg test) with a 10-min break between each post-consumption battery. The procedure was repeated for each beverage for each participant at least 48 h apart and within 30 min the same time of day using a random group assignment with blinding of researchers and subjects. To evaluate for changes in outcomes, a Treatment × Time analysis of covariance controlling for hours of prior night's sleep was used. Analysis of all outcomes and all treatment comparisons indicated that compared to placebo, both e+ shot ( Δ ¯   = 2.60; η 2 = 0.098) and caffeine ( Δ ¯   = 5.30, η 2 = 0.098) increased systolic BP 30 min post consumption (still within normal healthy ranges). The caffeine beverage also led to an improvement in most cognitive measures and moods 30-min post-consumption with improvements tapering at 69 and 108 min, while e+ shot noted more steady improvements with no significant differences between beverages on most cognitive and mood measures at 69 and 108 min. However, compared to caffeine, e+ shot noted a significant increase in reaction time at 108 min, while caffeine noted a small change in the opposite direction. No side-effects were reported by any intervention. These results suggest that the specific blend of adaptogens in e+ shot may modulate the neurocognitive effects of caffeine on mood, and cognition.",2020,"The caffeine beverage also led to an improvement in most cognitive measures and moods 30-min post-consumption with improvements tapering at 69 and 108 min, while e+ shot noted more steady improvements with no significant differences between beverages on most cognitive and mood measures at 69 and 108 min.",[],"['Placebo', 'caffeine', 'Caffeine', 'Caffeine-Containing, Adaptogenic-Rich Drink', 'caffeine-containing, adaptogenic herbal-rich natural energy shot (e+ shot), (b) a matched caffeine-containing shot (caffeine), and, (c) a placebo', 'placebo']","['Mental Performance and Cognitive Parameters', 'reaction time', 'motivation to perform cognitive tasks, mood, attention ((serial subtractions of 3 (SS3) and 7 (SS7), the continuous performance task (CPT), and the rapid visual input processing tasks)), heart rate (HR), blood pressure (BP), and motor coordination (nine-hole peg test) with a 10-min break between each post-consumption battery', 'systolic BP 30 min post consumption']",[],"[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0376667', 'cui_str': 'Herbals'}, {'cui': 'C0205296', 'cui_str': 'Natural'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0336766', 'cui_str': 'Matches'}]","[{'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0034746', 'cui_str': 'Response Time'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0031082', 'cui_str': 'Periodicals'}, {'cui': 'C4329232', 'cui_str': 'AX-CPT'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0242414', 'cui_str': 'Coordination'}, {'cui': 'C0451335', 'cui_str': 'Nine hole peg test'}, {'cui': 'C0052080', 'cui_str': 'antineoplaston A10'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0337088', 'cui_str': 'Electrical battery'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0456693', 'cui_str': '/30 min'}]",30.0,0.16417,"The caffeine beverage also led to an improvement in most cognitive measures and moods 30-min post-consumption with improvements tapering at 69 and 108 min, while e+ shot noted more steady improvements with no significant differences between beverages on most cognitive and mood measures at 69 and 108 min.","[{'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Boolani', 'Affiliation': 'Department of Physical Therapy, Clarkson University, Potsdam, NY 13699, USA.'}, {'ForeName': 'Daniel T', 'Initials': 'DT', 'LastName': 'Fuller', 'Affiliation': 'Department of Mathematics, Clarkson University, Potsdam, NY 13699, USA.'}, {'ForeName': 'Sumona', 'Initials': 'S', 'LastName': 'Mondal', 'Affiliation': 'Department of Mathematics, Clarkson University, Potsdam, NY 13699, USA.'}, {'ForeName': 'Tyler', 'Initials': 'T', 'LastName': 'Wilkinson', 'Affiliation': 'Department of Chemistry and Biomolecular Science, Clarkson University, Potsdam, NY 13699, USA.'}, {'ForeName': 'Costel C', 'Initials': 'CC', 'LastName': 'Darie', 'Affiliation': 'Department of Chemistry and Biomolecular Science, Clarkson University, Potsdam, NY 13699, USA.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Gumpricht', 'Affiliation': 'Isagenix International, LLC, Gilbert, AZ 85297, USA.'}]",Nutrients,['10.3390/nu12071922'] 2666,32610487,A Three-Arm Randomised Controlled Trial of High- and Low-Intensity Implementation Strategies to Support Centre-Based Childcare Service Implementation of Nutrition Guidelines: 12-Month Follow-Up.,"The study aimed to compare the effectiveness of a suite of implementation strategies of varying intensities on centre-based childcare service implementation of nutrition guideline recommendations at 12-month follow-up. A six-month three-arm parallel group randomised controlled trial was undertaken with 69 services, randomised to one of three arms: high-intensity strategies (executive support; group face-to-face training; provision of resources; multiple rounds of audit and feedback; ongoing face-to-face and phone support); low-intensity strategies (group face-to-face training; provision of resources; single round of audit and feedback); or usual care control. Across all study arms, only three high-intensity services were compliant with overall nutrition guidelines. A significant group interaction was found between the three arms for compliance with individual food groups. Relative to control, a significantly greater proportion of low-intensity services were compliant with dairy, and a significantly greater proportion of high-intensity services were compliant with fruit, vegetables, dairy, breads and cereals, and discretionary foods. No significant differences between the high- and low-intensity for individual food group compliance were found. High-intensity implementation strategies may be effective in supporting childcare service implementation of individual food group recommendations. Further research is warranted to identify strategies effective in increasing overall nutrition compliance.",2020,"Relative to control, a significantly greater proportion of low-intensity services were compliant with dairy, and a significantly greater proportion of high-intensity services were compliant with fruit, vegetables, dairy, breads and cereals, and discretionary foods.",['to Support Centre-Based Childcare Service Implementation of Nutrition Guidelines'],"['high-intensity strategies (executive support; group face-to-face training; provision of resources; multiple rounds of audit and feedback; ongoing face-to-face and phone support); low-intensity strategies (group face-to-face training; provision of resources; single round of audit and feedback); or usual care control', 'High- and Low-Intensity Implementation Strategies']",[],"[{'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C3658297', 'cui_str': 'Dietary Guidelines'}]","[{'cui': 'C4081854', 'cui_str': 'High intensity'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0332490', 'cui_str': 'Round shape'}, {'cui': 'C0450985', 'cui_str': 'Alcohol use disorders identification test'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0596836', 'cui_str': 'Light intensity'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205250', 'cui_str': 'High'}]",[],,0.0519355,"Relative to control, a significantly greater proportion of low-intensity services were compliant with dairy, and a significantly greater proportion of high-intensity services were compliant with fruit, vegetables, dairy, breads and cereals, and discretionary foods.","[{'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Grady', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, Callaghan 2308, Australia.'}, {'ForeName': 'Kirsty', 'Initials': 'K', 'LastName': 'Seward', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, Callaghan 2308, Australia.'}, {'ForeName': 'Meghan', 'Initials': 'M', 'LastName': 'Finch', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, Callaghan 2308, Australia.'}, {'ForeName': 'Luke', 'Initials': 'L', 'LastName': 'Wolfenden', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, Callaghan 2308, Australia.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Wyse', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, Callaghan 2308, Australia.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Wiggers', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, Callaghan 2308, Australia.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Lecathelinais', 'Affiliation': 'Hunter New England Local Health District, Population Health, Wallsend 2287, Australia.'}, {'ForeName': 'Sze Lin', 'Initials': 'SL', 'LastName': 'Yoong', 'Affiliation': 'School of Medicine and Public Health, University of Newcastle, Callaghan 2308, Australia.'}]",International journal of environmental research and public health,['10.3390/ijerph17134664'] 2667,32610581,"Pimasertib Versus Dacarbazine in Patients With Unresectable NRAS -Mutated Cutaneous Melanoma: Phase II, Randomized, Controlled Trial with Crossover.","This study investigated the efficacy and safety of pimasertib ( MEK 1/ MEK 2 inhibitor) versus dacarbazine (DTIC) in patients with untreated NRAS -mutated melanoma. Phase II, multicenter, open-label trial. Patients with unresectable, stage IIIc/IVM1 NRAS -mutated cutaneous melanoma were randomized 2:1 to pimasertib (60 mg; oral twice-daily) or DTIC (1000 mg/m 2 ; intravenously) on Day 1 of each 21-day cycle. Patients progressing on DTIC could crossover to pimasertib. Primary endpoint: investigator-assessed progression-free survival (PFS); secondary endpoints: overall survival (OS), objective response rate (ORR), quality of life (QoL), and safety. Overall, 194 patients were randomized (pimasertib n = 130, DTIC n = 64), and 191 received treatment (pimasertib n = 130, DTIC n = 61). PFS was significantly improved with pimasertib versus DTIC (median 13 versus 7 weeks, respectively; hazard ratio (HR) 0.59, 95% confidence interval (CI) 0.42-0.83; p = 0.0022). ORR was improved with pimasertib (odds ratio 2.24, 95% CI 1.00-4.98; p = 0.0453). OS was similar between treatments (median 9 versus 11 months, respectively; HR 0.89, 95% CI 0.61-1.30); 64% of patients receiving DTIC crossed over to pimasertib. Serious adverse events (AEs) were more frequent for pimasertib (57%) than DTIC (20%). The most common treatment-emergent AEs were diarrhea (82%) and blood creatine phosphokinase (CPK) increase (68%) for pimasertib, and nausea (41%) and fatigue (38%) for DTIC. Most frequent grade ≥3 AEs were CPK increase (34%) for pimasertib and neutropenia (15%) for DTIC. Mean QoL scores (baseline and last assessment) were similar between treatments. Pimasertib has activity in NRAS -mutated cutaneous melanoma and a safety profile consistent with known toxicities of MEK inhibitors. Trial registration: ClinicalTrials.gov, NCT01693068.",2020,"ORR was improved with pimasertib (odds ratio 2.24, 95% CI 1.00-4.98; p = 0.0453).","['patients with untreated NRAS -mutated melanoma', '194 patients were randomized (pimasertib n = 130, DTIC n = 64), and 191 received treatment (pimasertib n = 130, DTIC n = 61', 'Patients With Unresectable NRAS -Mutated Cutaneous Melanoma', 'Patients with unresectable, stage IIIc/IVM1', 'NRAS -mutated cutaneous melanoma']","['DTIC', 'Pimasertib Versus Dacarbazine', 'dacarbazine (DTIC']","['diarrhea', 'progression-free survival (PFS); secondary endpoints: overall survival (OS), objective response rate (ORR), quality of life (QoL), and safety', 'PFS', 'OS', 'fatigue', 'Serious adverse events (AEs', 'ORR', 'CPK increase', 'efficacy and safety', 'blood creatine phosphokinase (CPK) increase', 'pimasertib and neutropenia', 'Mean QoL scores', 'nausea']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0025202', 'cui_str': 'Malignant melanoma'}, {'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0010927', 'cui_str': 'Dacarbazine'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0456608', 'cui_str': 'Stage 3C'}]","[{'cui': 'C0010927', 'cui_str': 'Dacarbazine'}]","[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0151576', 'cui_str': 'Creatine phosphokinase increased'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0853034', 'cui_str': 'Blood creatine phosphokinase increased'}, {'cui': 'C0027947', 'cui_str': 'Neutropenic disorder'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}]",194.0,0.626062,"ORR was improved with pimasertib (odds ratio 2.24, 95% CI 1.00-4.98; p = 0.0453).","[{'ForeName': 'Celeste', 'Initials': 'C', 'LastName': 'Lebbé', 'Affiliation': 'AP-HP Dermatology CIC Department, Saint Louis Hospital, and INSERM U976, Université de Paris, 75010 Paris, France.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Dutriaux', 'Affiliation': 'Dermatology, Hopital Saint-Andre-CHU, 33000 Bordeaux, France.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Lesimple', 'Affiliation': 'Medical Oncology Department, Comprehensive Cancer Center Eugène Marquis, 35000 Rennes, France.'}, {'ForeName': 'Willem', 'Initials': 'W', 'LastName': 'Kruit', 'Affiliation': 'Internal Oncology, Erasmus MC Cancer Institute, 3008 AE Rotterdam, The Netherlands.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Kerger', 'Affiliation': 'Medical Oncology, Institut Jules Bordet, 1000 Brussels, Belgium.'}, {'ForeName': 'Luc', 'Initials': 'L', 'LastName': 'Thomas', 'Affiliation': 'Department of Dermatology, Centre Hospitalier Lyon Sud, 69310 Pierre Bénite, France.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Guillot', 'Affiliation': 'Department of Dermatology, Hôpital Saint Eloi, 34295 Montpellier, France.'}, {'ForeName': 'Filippo de', 'Initials': 'F', 'LastName': 'Braud', 'Affiliation': 'Department of Medical Oncology, Istituto Nazionale dei Tumori, Università degli Studi di Milano, 20133 Milano, Italy.'}, {'ForeName': 'Claus', 'Initials': 'C', 'LastName': 'Garbe', 'Affiliation': 'Department of Dermatology, University Hospital Tübingen, 72076 Tübingen, Germany.'}, {'ForeName': 'Jean-Jacques', 'Initials': 'JJ', 'LastName': 'Grob', 'Affiliation': 'Department of Dermatology and Cutaneous Oncology Service, Hôpital de la Timone, 13005 Marseille, France.'}, {'ForeName': 'Carmen', 'Initials': 'C', 'LastName': 'Loquai', 'Affiliation': 'Department of Dermatology, University Medical Center Mainz, 55019 Mainz, Germany.'}, {'ForeName': 'Virginia', 'Initials': 'V', 'LastName': 'Ferraresi', 'Affiliation': 'Division of Medical Oncology 1, IRCCS ""Regina Elena"" National Cancer Institute, 00144 Roma, Italy.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Robert', 'Affiliation': 'Dermatology Department, Institut Gustave Roussy and Paris Sud University, 94800 Villejuif, France.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Vasey', 'Affiliation': 'Icon Cancer Care, The Wesley Hospital, Auchenflower, QLD 4066, Australia.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Conry', 'Affiliation': 'Comprehensive Cancer Center, University of Alabama at Birmingham, Birmingham, AL 35233, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Isaacs', 'Affiliation': 'MidCentral Regional Cancer Treatment Service, Palmerston North Hospital, Palmerston North 4442, New Zealand.'}, {'ForeName': 'Enrique', 'Initials': 'E', 'LastName': 'Espinosa', 'Affiliation': 'Medical Oncology Department, Hospital Universitario La Paz, 28046 Madrid, Spain.'}, {'ForeName': 'Armin', 'Initials': 'A', 'LastName': 'Schueler', 'Affiliation': 'Global Biostatistics Oncology, Merck KGaA, 64293 Darmstadt, Germany.'}, {'ForeName': 'Giorgio', 'Initials': 'G', 'LastName': 'Massimini', 'Affiliation': 'GCDU Oncology, Merck KGaA, 64293 Darmstadt, Germany.'}, {'ForeName': 'Brigitte', 'Initials': 'B', 'LastName': 'Dréno', 'Affiliation': 'Department of Dermato Cancerology, CIC 1413, CRCINA Inserm 1232, CHU Nantes, 44093 Nantes, France.'}]",Cancers,['10.3390/cancers12071727'] 2668,32610608,The Effects of Timing of a Leucine-Enriched Amino Acid Supplement on Body Composition and Physical Function in Stroke Patients: A Randomized Controlled Trial.,"The combination of exercise and nutritional intervention is widely used for stroke patients, as well as frail or sarcopenic older persons. As previously shown, supplemental branched chain amino acids (BCAAs) or protein to gain muscle mass has usually been given just after exercise. This study investigated the effect of the timing of supplemental BCAAs with exercise intervention on physical function in stroke patients. The participants were randomly assigned to two groups based on the timing of supplementation: breakfast ( n = 23) and post-exercise ( n = 23). The supplement in the breakfast group was provided at 08:00 with breakfast, and in the post-exercise group it was provided just after the exercise session in the afternoon at 14:00-18:00. In both groups, the exercise intervention was performed with two sessions a day for two months. The main effects were observed in body fat mass ( p = 0.02, confidence interval (CI): 13.2-17.7), leg press strength ( p = 0.04, CI: 94.5-124.5), and Berg balance scale ( p = 0.03, CI: 41.6-52.6), but no interaction with intake timing was observed. Although the effect of the timing of supplementation on skeletal muscle mass was similar in both groups, BCAA intake with breakfast was effective for improving physical performance and decreasing body fat mass. The results suggest that a combination of BCAA intake with breakfast and an exercise program was effective for promoting rehabilitation of post-stroke patients.",2020,"The main effects were observed in body fat mass ( p = 0.02, confidence interval (CI): 13.2-17.7), leg press strength ( p = 0.04, CI: 94.5-124.5), and Berg balance scale ( p = 0.03, CI: 41.6-52.6), but no interaction with intake timing was observed.","['stroke patients, as well as frail or sarcopenic older persons', 'stroke patients', 'Stroke Patients']","['supplemental branched chain amino acids (BCAAs', 'supplemental BCAAs with exercise intervention', 'exercise and nutritional intervention', 'exercise program', 'exercise intervention', 'Leucine-Enriched Amino Acid Supplement', 'supplementation: breakfast ( n = 23) and post-exercise']","['physical function', 'Body Composition and Physical Function', 'Berg balance scale', 'skeletal muscle mass', 'physical performance and decreasing body fat mass', 'leg press strength', 'body fat mass']","[{'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0079377', 'cui_str': 'Frail elderly'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0002521', 'cui_str': 'Branched-chain amino acid'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0086153', 'cui_str': 'Diet Modification'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0023401', 'cui_str': 'Leucine'}, {'cui': 'C0556082', 'cui_str': 'Amino acid supplement'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C2698559', 'cui_str': 'Breakfast time'}, {'cui': 'C1979962', 'cui_str': 'After exercise'}]","[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C1998325', 'cui_str': 'Berg balance scale'}, {'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}]",,0.0522278,"The main effects were observed in body fat mass ( p = 0.02, confidence interval (CI): 13.2-17.7), leg press strength ( p = 0.04, CI: 94.5-124.5), and Berg balance scale ( p = 0.03, CI: 41.6-52.6), but no interaction with intake timing was observed.","[{'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Ikeda', 'Affiliation': 'School of Nursing and Rehabilitation Sciences, Showa University, Tokaichiba 1865, Midori ward, Yokohama, Kanagawa 236-0001, Japan.'}, {'ForeName': 'Nobuo', 'Initials': 'N', 'LastName': 'Morotomi', 'Affiliation': 'Department of Rehabilitation Medicine, Showa University Fujigaoka Rehabilitation Hospital, 2-1-1, Aoba ward, Yokohama, Kanagawa 236-0001, Japan.'}, {'ForeName': 'Arinori', 'Initials': 'A', 'LastName': 'Kamono', 'Affiliation': 'School of Nursing and Rehabilitation Sciences, Showa University, Tokaichiba 1865, Midori ward, Yokohama, Kanagawa 236-0001, Japan.'}, {'ForeName': 'Saki', 'Initials': 'S', 'LastName': 'Ishimoto', 'Affiliation': 'Department of Health and Welfare, Health promotion section, Yamato, Kanagawa 236-0001, Japan.'}, {'ForeName': 'Ryo', 'Initials': 'R', 'LastName': 'Miyazawa', 'Affiliation': 'Rehabilitation Center, Showa University Fujigaoka Rehabilitation Hospital, Fujigaoka 2-1-1, Aoba ward, Yokohama, Kanagawa 236-0001, Japan.'}, {'ForeName': 'Shogo', 'Initials': 'S', 'LastName': 'Kometani', 'Affiliation': 'Rehabilitation Center, Showa University Fujigaoka Rehabilitation Hospital, Fujigaoka 2-1-1, Aoba ward, Yokohama, Kanagawa 236-0001, Japan.'}, {'ForeName': 'Rikitaro', 'Initials': 'R', 'LastName': 'Sako', 'Affiliation': 'Rehabilitation Center, Showa University Fujigaoka Rehabilitation Hospital, Fujigaoka 2-1-1, Aoba ward, Yokohama, Kanagawa 236-0001, Japan.'}, {'ForeName': 'Naohisa', 'Initials': 'N', 'LastName': 'Kaneko', 'Affiliation': 'Department of Rehabilitation Medicine, Showa University Fujigaoka Rehabilitation Hospital, 2-1-1, Aoba ward, Yokohama, Kanagawa 236-0001, Japan.'}, {'ForeName': 'Mamoru', 'Initials': 'M', 'LastName': 'Iida', 'Affiliation': 'Department of Rehabilitation Medicine, Showa University Fujigaoka Rehabilitation Hospital, 2-1-1, Aoba ward, Yokohama, Kanagawa 236-0001, Japan.'}, {'ForeName': 'Nobuyuki', 'Initials': 'N', 'LastName': 'Kawate', 'Affiliation': 'Department of Rehabilitation Medicine, Showa University Fujigaoka Rehabilitation Hospital, 2-1-1, Aoba ward, Yokohama, Kanagawa 236-0001, Japan.'}]",Nutrients,['10.3390/nu12071928'] 2669,32610634,Do Infants at Risk of Developing Cerebral Palsy or Other Neurodevelopmental Disorders Learn What They Practice?,"Through secondary analyses of the Small Step. Randomized Control Trial, we tested the hypothesis that children at risk of developing cerebral palsy (CP) or other neurodevelopmental disorders would learn what they practice, i.e., that they would have a more rapid development within the specifically trained foci (hand use or mobility) of each time period compared to the development rate within the foci not trained at that time. Nineteen infants (6.3 (1.62) months corrected age) included in the Small Step program were assessed at six time points during the intervention. For statistical analysis, general and mixed linear models were used, and the independent variables were the Peabody Developmental Motor scale (stationary, locomotion, grasping and visuomotor sub scales), the Gross Motor Function Measure-66 and the Hand Assessment for Infants. Outcomes related to gross motor function improved significantly more after mobility training than after hand use training, while fine motor function was improved to the same extent following both training types. Significantly higher improvements after the first training period were seen in one out of three outcome measures in both gross and fine motor assessments. The improvements observed were all independent of diagnosis at two years. The concept ""you learn what you practice"" was most clearly confirmed in the case of gross motor development.",2020,Significantly higher improvements after the first training period were seen in one out of three outcome measures in both gross and fine motor assessments.,"['children at risk of developing cerebral palsy (CP) or other neurodevelopmental disorders', 'Nineteen infants (6.3 (1.62) months corrected age) included in the Small Step program']",[],"['gross motor function', 'Peabody Developmental Motor scale (stationary, locomotion, grasping and visuomotor sub scales), the Gross Motor Function Measure-66 and the Hand Assessment for Infants', 'fine motor function']","[{'cui': 'C0425119', 'cui_str': 'Child at risk'}, {'cui': 'C0007789', 'cui_str': 'Cerebral palsy'}, {'cui': 'C1535926', 'cui_str': 'Neurodevelopmental disorder'}, {'cui': 'C0450337', 'cui_str': '19'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C4319697', 'cui_str': '6.3'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]",[],"[{'cui': 'C0677549', 'cui_str': 'Gross motor functions'}, {'cui': 'C0458003', 'cui_str': 'Developmental'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0439835', 'cui_str': 'Stationary'}, {'cui': 'C0023946', 'cui_str': 'Locomotor Activity'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0562229', 'cui_str': 'Fine motor functions'}]",19.0,0.0177285,Significantly higher improvements after the first training period were seen in one out of three outcome measures in both gross and fine motor assessments.,"[{'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Löwing', 'Affiliation': ""Neuropediatric Unit, Department of Women's and Children's Health, Karolinska Institutet, SE-171 76 Stockholm, Sweden.""}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Holmström', 'Affiliation': ""Neuropediatric Unit, Department of Women's and Children's Health, Karolinska Institutet, SE-171 76 Stockholm, Sweden.""}, {'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Almeida', 'Affiliation': 'Stockholm University Brain Imaging Center (SUBIC), Stockholm University, SE-106 91 Stockholm, Sweden.'}, {'ForeName': 'Ann-Christin', 'Initials': 'AC', 'LastName': 'Eliasson', 'Affiliation': ""Neuropediatric Unit, Department of Women's and Children's Health, Karolinska Institutet, SE-171 76 Stockholm, Sweden.""}]",Journal of clinical medicine,['10.3390/jcm9072041'] 2670,32611117,Does following optimized routes for single cars improve car routing?,"We study the impact of deserting a pre-established path, determined by a navigation software, on the overall city traffic. To do so, we consider a cellular automaton model for vehicular traffic, where the cars travel between two randomly assigned points in the city following three different navigation strategies based on the minimization of the individual paths or travel times. We found, in general, that, above a critical car density, the transport improves in all strategies if we decrease the time that the vehicles persist in trying to follow a particular strategy when a route is blocked, namely, the mean flux increases, the individual travel times decrease, and the fluctuations of density in the streets decrease; consequently, deserting helps prevent traffic jams.",2020,"We found, in general, that, above a critical car density, the transport improves in all strategies if we decrease the time that the vehicles persist in trying to follow a particular strategy when a route is blocked, namely, the mean flux increases, the individual travel times decrease, and the fluctuations of density in the streets decrease; consequently, deserting helps prevent traffic jams.",[],[],[],[],[],[],,0.0339853,"We found, in general, that, above a critical car density, the transport improves in all strategies if we decrease the time that the vehicles persist in trying to follow a particular strategy when a route is blocked, namely, the mean flux increases, the individual travel times decrease, and the fluctuations of density in the streets decrease; consequently, deserting helps prevent traffic jams.","[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Carrasco', 'Affiliation': 'Departamento de Física, Facultad de Ciencias, Universidad de Chile, Casilla 653, Santiago 7800024, Chile.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Medina', 'Affiliation': 'Departamento de Física, Facultad de Ciencias, Universidad de Chile, Casilla 653, Santiago 7800024, Chile.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Rogan', 'Affiliation': 'Departamento de Física, Facultad de Ciencias, Universidad de Chile, Casilla 653, Santiago 7800024, Chile.'}, {'ForeName': 'J A', 'Initials': 'JA', 'LastName': 'Valdivia', 'Affiliation': 'Departamento de Física, Facultad de Ciencias, Universidad de Chile, Casilla 653, Santiago 7800024, Chile.'}]","Chaos (Woodbury, N.Y.)",['10.1063/1.5145309'] 2671,32611217,Public Perceptions of Artificial Intelligence and Robotics in Medicine.,"OBJECTIVE To understand better the public perception and comprehension of medical technology such as artificial intelligence and robotic surgery. Additionally, to identify sensitivity to their use in order to ensure acceptability and quality of counseling. SUBJECTS AND METHODS A survey was conducted on a convenience sample of visitors to the MN Minnesota State Fair (n= 264). Participants were randomized to receive one of two similar surveys. In the first a diagnosis was made by a physician and in the second by an AI application in order to compare confidence in human and computer-based diagnosis. RESULTS The median age of participants was 45 (IQR 28-59), 58% were female (n=154) vs. 42% male (n=110), 69% had completed at least a bachelor's degree, 88% were Caucasian (n=233) vs. 12% ethnic minorities (n=31) and were from 12 states, most from the Upper Midwest. Participants had nearly equal trust in AI vs. physician diagnoses, However, they were significantly more likely to trust an AI diagnosis of cancer over a doctor's diagnosis when responding to the version of the survey that suggested an AI could make medical diagnosis (p = 9.32e-06). Though 55% of respondents (n=145) reported they were uncomfortable with automated robotic surgery the majority of the individuals surveyed, (88%), mistakenly believed that partially autonomous surgery was already happening. Almost all (94%, n=249) stated they would be willing to pay for a review of medical imaging by an AI if available. CONCLUSION Most participants express confidence in AI providing medical diagnoses, sometimes even over human physicians. Participants generally expressed concern with surgical AI, but mistakenly believe it is already being performed. As AI applications increase in medical practice, health care providers should be cognizant of the potential amount of misinformation and sensitivity that patients have to how such technology is represented.",2020,"Almost all (94%, n=249) stated they would be willing to pay for a review of medical imaging by an AI if available. ","[""The median age of participants was 45 (IQR 28-59), 58% were female (n=154) vs. 42% male (n=110), 69% had completed at least a bachelor's degree, 88% were Caucasian (n=233) vs. 12% ethnic minorities (n=31) and were from 12 states, most from the Upper Midwest"", 'convenience sample of visitors to the MN Minnesota State Fair (n= 264']",[],['acceptability and quality of counseling'],"[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0337600', 'cui_str': 'Bachelor'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0007457', 'cui_str': 'Caucasian'}, {'cui': 'C0015031', 'cui_str': 'Ethnic group'}, {'cui': 'C0026192', 'cui_str': 'Minority Groups'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C3831015', 'cui_str': 'Convenient'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0026183', 'cui_str': 'Minnesota'}, {'cui': 'C2911689', 'cui_str': 'Fair'}]",[],"[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}]",88.0,0.0315296,"Almost all (94%, n=249) stated they would be willing to pay for a review of medical imaging by an AI if available. ","[{'ForeName': 'Bethany', 'Initials': 'B', 'LastName': 'Stai', 'Affiliation': 'University of Minnesota Twin Cities, 5635, Computer Science and Engineering, 200 Union Street SE, 4-192 Keller Hall, Minneapolis, Minnesota, United States, 55455; dikke007@umn.edu.'}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Heller', 'Affiliation': 'University of Minnesota Twin Cities, 5635, Computer Science and Engineering, Minneapolis, Minnesota, United States; helle246@umn.edu.'}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'McSweeney', 'Affiliation': 'University of Minnesota Twin Cities, 5635, Department of Urology, Minneapolis, Minnesota, United States; mcswe027@umn.edu.'}, {'ForeName': 'Jack', 'Initials': 'J', 'LastName': 'Rickman', 'Affiliation': 'University of Minnesota Twin Cities, 5635, Computer Science and Engineering, Minneapolis, Minnesota, United States; rickm014@umn.edu.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Blake', 'Affiliation': 'University of Minnesota Twin Cities, 5635, Department of Urology, Minneapolis, Minnesota, United States; blake367@umn.edu.'}, {'ForeName': 'Ranveer', 'Initials': 'R', 'LastName': 'Vasdev', 'Affiliation': 'University of Minnesota Twin Cities, 5635, Department of Urology, Minneapolis, Minnesota, United States; vasde005@umn.edu.'}, {'ForeName': 'Zach', 'Initials': 'Z', 'LastName': 'Edgerton', 'Affiliation': 'University of Minnesota Twin Cities, 5635, Department of Urology, Minneapolis, Minnesota, United States; edger025@umn.edu.'}, {'ForeName': 'Resha', 'Initials': 'R', 'LastName': 'Tejpaul', 'Affiliation': 'University of Minnesota Twin Cities, 5635, Minneapolis, Minnesota, United States; teipa005@umn.edu.'}, {'ForeName': 'Matt', 'Initials': 'M', 'LastName': 'Peterson', 'Affiliation': 'University of Minnesota Twin Cities, 5635, Department of Urology, Minneapolis, Minnesota, United States; pet00864@d.umn.edu.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Rosenberg', 'Affiliation': 'University of Minnesota Twin Cities, 5635, Department of Urology, 325 SE Harvard St, Minneapolis, Minnesota, United States, 55414; rosenber@umn.edu.'}, {'ForeName': 'Arveen', 'Initials': 'A', 'LastName': 'Kalapara', 'Affiliation': 'University of Minnesota Twin Cities, 5635, Department of Urology, Minneapolis, Minnesota, United States; akalapar@umn.edu.'}, {'ForeName': 'Subodh', 'Initials': 'S', 'LastName': 'Regmi', 'Affiliation': 'University of Minnesota Twin Cities, 5635, Department of Urology, Minneapolis, Minnesota, United States; regmi014@umn.edu.'}, {'ForeName': 'Nikolaos', 'Initials': 'N', 'LastName': 'Papanikolopoulos', 'Affiliation': 'University of Minnesota Twin Cities, 5635, Computer Science and Engineering, Minneapolis, Minnesota, United States; papan001@umn.edu.'}, {'ForeName': 'Christopher J', 'Initials': 'CJ', 'LastName': 'Weight', 'Affiliation': 'University of Minnesota, Department of Urology, Minneapolis, Minnesota, United States; cjweight@umn.edu.'}]",Journal of endourology,['10.1089/end.2020.0137'] 2672,32605239,Efficacy of a U-Shaped Automatic Electric Toothbrush in Dental Plaque Removal: A Cross-Over Randomized Controlled Trial.,"BACKGROUND The aim of this single-use, four-treatment, four-period (visit), cross-over, mono-centered, examiner-blind, cross-over randomized controlled trial (RCT) was to evaluate the efficacy in dental plaque removal of a U-shaped automatic electric toothbrush (U) compared to a conventional powered toothbrush (P), a habitual toothbrushing procedure (H), and no brushing (N). METHODS Eligible participants were volunteer students. Primary outcome measure was the reduction in full-mouth plaque score (FMPS) after brushing. The secondary outcome variable was a visual analogic scale (VAS) on subjective clean mouth sensation. Mixed models were performed for difference in FMPS and VAS. RESULTS Twenty-two participants were randomized to the treatments in the four periods of the study. The differences between treatments in FMPS reduction after brushing were statistically significant ( p < 0.0001). The differences were statistically significant between the U and P groups (difference -48; 95% CI from -54 to -41) favoring the P group, and between the U and H groups (difference -45; 95% CI from -52 to -39) favoring the H group. On the contrary, the difference between the U and N groups was not significant (difference 5; 95% CI from -2 to 12) favoring the U group. The differences between treatments in clean mouth VAS was statistically significant ( p < 0.0001) favoring the P and H groups. CONCLUSIONS The U-shaped automatic electric toothbrush tested in this study proved to be not effective in removing dental plaque.",2020,"The differences between treatments in clean mouth VAS was statistically significant ( p < 0.0001) favoring the P and H groups. ","['Eligible participants were volunteer students', 'Dental Plaque Removal', 'Twenty-two participants']","['conventional powered toothbrush (P), a habitual toothbrushing procedure (H), and no brushing (N', 'U-Shaped Automatic Electric Toothbrush']","['visual analogic scale (VAS) on subjective clean mouth sensation', 'clean mouth VAS', 'reduction in full-mouth plaque score (FMPS', 'FMPS reduction']","[{'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C4284772', 'cui_str': '22'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0032863', 'cui_str': 'Power (Psychology)'}, {'cui': 'C0183975', 'cui_str': 'Toothbrush'}, {'cui': 'C0205353', 'cui_str': 'Habitual'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0332479', 'cui_str': 'Shape finding'}, {'cui': 'C0205554', 'cui_str': 'Automated'}, {'cui': 'C1740271', 'cui_str': 'Electric toothbrush'}]","[{'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0402683', 'cui_str': 'Cleaner'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0036658', 'cui_str': 'Sensory perception'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0221732', 'cui_str': 'Mouth plaque'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",22.0,0.133698,"The differences between treatments in clean mouth VAS was statistically significant ( p < 0.0001) favoring the P and H groups. ","[{'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Nieri', 'Affiliation': 'Department of Experimental and Clinical Medicine, Orthodontics, Università degli Studi di Firenze, 50127 Firenze, Italy.'}, {'ForeName': 'Veronica', 'Initials': 'V', 'LastName': 'Giuntini', 'Affiliation': 'School of Dentistry, Department of Experimental and Clinical Medicine, Università degli Studi di Firenze, 50127 Firenze, Italy.'}, {'ForeName': 'Umberto', 'Initials': 'U', 'LastName': 'Pagliaro', 'Affiliation': 'School of Dentistry, Department of Experimental and Clinical Medicine, Università degli Studi di Firenze, 50127 Firenze, Italy.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Giani', 'Affiliation': 'Private Practice, Campi Bisenzio, 50013 Firenze, Italy.'}, {'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Franchi', 'Affiliation': 'School of Dentistry, Department of Experimental and Clinical Medicine, Università degli Studi di Firenze, 50127 Firenze, Italy.'}, {'ForeName': 'Debora', 'Initials': 'D', 'LastName': 'Franceschi', 'Affiliation': 'School of Dentistry, Department of Experimental and Clinical Medicine, Università degli Studi di Firenze, 50127 Firenze, Italy.'}]",International journal of environmental research and public health,['10.3390/ijerph17134649'] 2673,32605284,Acute Effects of Beetroot Juice Supplements on Resistance Training: A Randomized Double-Blind Crossover.,"The ingestion of beetroot juice (BJ) has been associated with improvements in physical performance in endurance sports, however the literature on resistance training (RT) is scarce. The aim of this study was to investigate the acute effects of BJ compared to a placebo (PLA) on muscular endurance and movement concentric velocity during RT. Twelve healthy men performed an incremental RT test (back squat and bench press) with three sets, at 60%, 70%, and 80% of their repetition maximum (1-RM). Movement velocity variables, total number of repetitions performed until concentric failure, blood lactate, and ratings of perceived effort post-training were measured. A higher number of repetitions were recorded with BJ compared to those with PLA (13.8 ± 14.4; p < 0.01; effect size (ES) = 0.6). Differences were found at 60% 1-RM (9 ± 10; p < 0.05; ES = 0.61) and 70% 1-RM (3.1 ± 4.8; p < 0.05; ES = 0.49), however, no differences were found at 80% 1-RM (1.7 ± 1; p = 0.12; ES = 0.41). A greater number of repetitions was performed in back squat (13.4 ± 13; p < 0.01; ES = 0.77), but no differences were observed in bench press (0.4 ± 5.1; p = 0.785; ES = 0.03). No differences were found for the rest of the variables ( p > 0.05). Acute supplementation of BJ improved muscular endurance performance in RT.",2020,"A greater number of repetitions was performed in back squat (13.4 ± 13; p < 0.01; ES = 0.77), but no differences were observed in bench press (0.4 ± 5.1; p = 0.785; ES = 0.03).",['Twelve healthy men'],"['placebo (PLA', 'BJ', 'Beetroot Juice Supplements']","['muscular endurance performance', 'number of repetitions', 'Movement velocity variables, total number of repetitions performed until concentric failure, blood lactate, and ratings of perceived effort post-training', 'muscular endurance and movement concentric velocity', 'Resistance Training']","[{'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C1095905', 'cui_str': 'Beets preparation'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}]","[{'cui': 'C0442025', 'cui_str': 'Muscular'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0439744', 'cui_str': 'Concentric'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0872279', 'cui_str': 'Strength Training'}]",12.0,0.161723,"A greater number of repetitions was performed in back squat (13.4 ± 13; p < 0.01; ES = 0.77), but no differences were observed in bench press (0.4 ± 5.1; p = 0.785; ES = 0.03).","[{'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Ranchal-Sanchez', 'Affiliation': 'Maimonides Biomedical Research Institute of Cordoba (IMIBIC), University of Cordoba, 14004 Córdoba, Spain.'}, {'ForeName': 'Victor Manuel', 'Initials': 'VM', 'LastName': 'Diaz-Bernier', 'Affiliation': 'Department of Nursing, Pharmacology and Physiotherapy, Faculty of Medicine and Nursing, University of Cordoba, 14071 Córdoba, Spain.'}, {'ForeName': 'Candelaria Alonso', 'Initials': 'CA', 'LastName': 'De La Florida-Villagran', 'Affiliation': 'Department of Nursing, Pharmacology and Physiotherapy, Faculty of Medicine and Nursing, University of Cordoba, 14071 Córdoba, Spain.'}, {'ForeName': 'Francisco Jesus', 'Initials': 'FJ', 'LastName': 'Llorente-Cantarero', 'Affiliation': 'Department of Specific Didactics, Faculty of Education, University of Cordoba, 14071 Córdoba, Spain.'}, {'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Campos-Perez', 'Affiliation': 'Department of Food Science and Technology, Rabanales University Campus, University of Cordoba, 14071 Córdoba, Spain.'}, {'ForeName': 'Jose Manuel', 'Initials': 'JM', 'LastName': 'Jurado-Castro', 'Affiliation': 'Metabolism and Investigation Unit, Maimonides Biomedical Research Institute of Cordoba (IMIBIC), Reina Sofia University Hospital, University of Cordoba, 14004 Córdoba, Spain.'}]",Nutrients,['10.3390/nu12071912'] 2674,32605298,Efficacy of Panitumumab and Cetuximab in Patients with Colorectal Cancer Previously Treated with Bevacizumab; a Combined Analysis of Individual Patient Data from ASPECCT and WJOG6510G.,"BACKGROUND Phase-III ASPECCT and randomised phase-II WJOG6510G trials demonstrated the noninferiority of panitumumab, when compared with cetuximab, for overall survival in patients with chemotherapy-refractory wild-type KRAS exon 2 metastatic colorectal cancer. METHODS The subgroup that received bevacizumab either prior to panitumumab or cetuximab monotherapy (ASPECCT) or in combination with irinotecan (WJOG6510G) was included. Multivariate Cox models were created, including the treatment arms as covariates together with patient, disease and treatment characteristics. RESULTS We included 185 and 189 patients in the panitumumab and cetuximab arms, respectively. The median overall survival was 12.8 and 10.1 months [ p = 0.0031; log-rank test, stratified by trial; hazard ratio (HR), 0.72; 95% confidence interval (CI), 0.58-0.90], and the median progression-free survival was 4.7 and 4.1 months, in the panitumumab and cetuximab arms, respectively ( p = 0.0207; HR, 0.79; 95% CI, 0.64-0.97). The treatment regimen was an independent prognostic factor of overall survival (adjusted HR, 0.69; 95% CI, 0.54-0.87; p = 0.0013). CONCLUSIONS Panitumumab significantly prolonged the overall survival and progression-free survival, when compared with cetuximab in the cohort that previously received bevacizumab in the included studies. Clinical Trial Registration : ASPECCT trial registered with ClinicalTrials.gov (NCT01001377) and WJOG6510G trial registered with UMIN-CTR (UMIN000006643).",2020,"G trials demonstrated the noninferiority of panitumumab, when compared with cetuximab, for overall survival in patients with chemotherapy-refractory wild-type KRAS exon 2 metastatic colorectal cancer. ","['patients with chemotherapy-refractory wild-type KRAS exon 2 metastatic colorectal cancer', '185 and 189 patients in the panitumumab and cetuximab arms, respectively', 'Patients with Colorectal Cancer']","['Bevacizumab', 'WJOG6510', 'cetuximab', 'ASPECCT and WJOG6510G', 'bevacizumab either prior to panitumumab or cetuximab monotherapy (ASPECCT) or in combination with irinotecan (WJOG6510G', 'panitumumab', 'Panitumumab and Cetuximab', 'bevacizumab']","['median progression-free survival', 'overall survival', 'median overall survival', 'prognostic factor of overall survival', 'overall survival and progression-free survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0445392', 'cui_str': 'Wild'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0015295', 'cui_str': 'Exons'}, {'cui': 'C4721579', 'cui_str': 'Secondary malignant neoplasm of colon and/or rectum'}, {'cui': 'C4517617', 'cui_str': '185'}, {'cui': 'C0879427', 'cui_str': 'panitumumab'}, {'cui': 'C0995188', 'cui_str': 'cetuximab'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}]","[{'cui': 'C0796392', 'cui_str': 'bevacizumab'}, {'cui': 'C0995188', 'cui_str': 'cetuximab'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0879427', 'cui_str': 'panitumumab'}, {'cui': 'C0123931', 'cui_str': 'irinotecan'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C1514474', 'cui_str': 'Prognostic Factors'}]",,0.446552,"G trials demonstrated the noninferiority of panitumumab, when compared with cetuximab, for overall survival in patients with chemotherapy-refractory wild-type KRAS exon 2 metastatic colorectal cancer. ","[{'ForeName': 'Hiroya', 'Initials': 'H', 'LastName': 'Taniguchi', 'Affiliation': 'Department of Gastroenterology and Gastrointestinal Oncology, National Cancer Centre Hospital East, Kashiwa 277-8577, Japan.'}, {'ForeName': 'Takeharu', 'Initials': 'T', 'LastName': 'Yamanaka', 'Affiliation': 'Department of Biostatistics, Yokohama City University School of Medicine, Yokohama 236-0004, Japan.'}, {'ForeName': 'Daisuke', 'Initials': 'D', 'LastName': 'Sakai', 'Affiliation': 'Frontier Science for Cancer and Chemotherapy, Osaka University Graduate School of Medicine, Suita 565-0871, Japan.'}, {'ForeName': 'Kei', 'Initials': 'K', 'LastName': 'Muro', 'Affiliation': 'Department of Clinical Oncology, Aichi Cancer Centre, Nagoya 464-8681, Japan.'}, {'ForeName': 'Kentaro', 'Initials': 'K', 'LastName': 'Yamazaki', 'Affiliation': 'Division of Gastrointestinal Oncology, Shizuoka Cancer Centre, Shizuoka 411-8777, Japan.'}, {'ForeName': 'Susumu', 'Initials': 'S', 'LastName': 'Nakata', 'Affiliation': 'Department of Clinical Oncology, Kyoto Pharmaceutical University, Kyoto 607-8414, Japan.'}, {'ForeName': 'Hiroyuki', 'Initials': 'H', 'LastName': 'Kimura', 'Affiliation': 'Department of Analytical and Bioinorganic Chemistry, Kyoto Pharmaceutical University, Kyoto 607-8414, Japan.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Ruff', 'Affiliation': 'University of Witwatersrand MRC Common Epithelial Cancers Research Centre, Johannesburg 2193, South Africa.'}, {'ForeName': 'Tae Won', 'Initials': 'TW', 'LastName': 'Kim', 'Affiliation': 'Department of Oncology, Asan Medical Centre, University of Ulsan College of Medicine, Seoul 05505, Korea.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Peeters', 'Affiliation': 'Department of Oncology, U.Z.A. University Hospital Antwerp, 2650 Edegem, Belgium.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Price', 'Affiliation': 'Department of Medical Oncology, Queen Elizabeth Hospital and University of Adelaide, 5011 Woodville, Australia.'}]",Cancers,['10.3390/cancers12071715'] 2675,32605389,Management of migrated or residual stones following laparoscopic pyelolithotomy and ureterolithotomy in abnormal kidneys - a prospective and randomized comparison.,"Objective To conduct a prospective and randomized controlled trial comparing contemporaneous transabdominal rigid ureteroscopy (TRU) with postoperative shock wave lithotripsy (SWL) in the management of migrated or residual stones during laparoscopic pyelolithotomy and ureterolithotomy in kidneys with either intrinsic or extrinsic abnormalities. Methods From February 2016 to December 2019, 45 patients with migrated or residual stones following laparoscopic pyelolithotomy and ureterolithotomy were accrued and randomly divided into two groups. These patients all had either urinary tract obstruction distal to the stone or concomitant ipsilateral intrinsic or extrinsic pathology requiring laparoscopic intervention. 23 patients underwent contemporaneous TRU and 22 patients underwent postoperative SWL. Patients' demographics, perioperative variables, and follow-up data were collected. The primary outcome was the final stone free rate (SFR) at the two-month follow up. Secondary outcomes included blood loss, operative time, change in serum creatinine, complications per Clavien-Dindo grading system, renal colic occurrence rate (RCOR), and postoperative hospitalization. Results There was no significant difference in gender, age, body mass index, location, or stone burden between the two groups (P >0.05). At the two-month follow ups, the SFR was higher in the TRU than the SWL group (P = 0.002), and the RCOR was lower in the TRU than the SWL group (P = 0.005). Postoperative hospitalization was also shorter for the TRU group. No significant difference was noted in the operative time, blood loss, change in serum creatinine, or perioperative complications (P > 0.05). Conclusion Contemporaneous TRU is more effective and equally safe when compared to postoperative SWL in the management of residual or migrated stones during laparoscopic pyelolithotomy and ureterolithotomy in kidneys with either intrinsic or extrinsic abnormalities.",2020,"At the two-month follow ups, the SFR was higher in the TRU than the SWL group (P = 0.002), and the RCOR was lower in the TRU than the SWL group (P = 0.005).","['patients all had either urinary tract obstruction distal to the stone or concomitant ipsilateral intrinsic or extrinsic pathology requiring laparoscopic intervention', 'Methods From February 2016 to December 2019, 45 patients with migrated or residual stones following laparoscopic pyelolithotomy and ureterolithotomy', '23 patients underwent', 'migrated or residual stones during laparoscopic pyelolithotomy and ureterolithotomy in kidneys with either intrinsic or extrinsic abnormalities']","['postoperative SWL', 'contemporaneous TRU', 'laparoscopic pyelolithotomy and ureterolithotomy', 'contemporaneous transabdominal rigid ureteroscopy (TRU) with postoperative shock wave lithotripsy (SWL']","['RCOR', 'gender, age, body mass index, location, or stone burden', 'blood loss, operative time, change in serum creatinine, complications per Clavien-Dindo grading system, renal colic occurrence rate (RCOR), and postoperative hospitalization', 'Postoperative hospitalization', 'operative time, blood loss, change in serum creatinine, or perioperative complications', 'final stone free rate (SFR', 'SFR']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0178879', 'cui_str': 'Urinary tract obstruction'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0006736', 'cui_str': 'Calculus'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0441989', 'cui_str': 'Ipsilateral'}, {'cui': 'C0205102', 'cui_str': 'Internal'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0543419', 'cui_str': 'Sequela of disorder'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C2959846', 'cui_str': 'Laparoscopic pyelolithotomy'}, {'cui': 'C0194229', 'cui_str': 'Ureterolithotomy'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0000768', 'cui_str': 'Congenital malformation'}]","[{'cui': 'C0032792', 'cui_str': 'Postoperative shock'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0023878', 'cui_str': 'Lithotripsy'}, {'cui': 'C0205496', 'cui_str': 'Abdominal approach'}, {'cui': 'C0026837', 'cui_str': 'Muscle rigidity'}, {'cui': 'C0194261', 'cui_str': 'Ureteroscopy'}, {'cui': 'C2959846', 'cui_str': 'Laparoscopic pyelolithotomy'}, {'cui': 'C0194229', 'cui_str': 'Ureterolithotomy'}, {'cui': 'C0036974', 'cui_str': 'Shock'}]","[{'cui': 'C0152169', 'cui_str': 'Renal colic'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0450429', 'cui_str': 'Location'}, {'cui': 'C0006736', 'cui_str': 'Calculus'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C1273712', 'cui_str': 'Grading system used'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C4545429', 'cui_str': 'Perioperative complication'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0332296', 'cui_str': 'Free of'}]",45.0,0.0492596,"At the two-month follow ups, the SFR was higher in the TRU than the SWL group (P = 0.002), and the RCOR was lower in the TRU than the SWL group (P = 0.005).","[{'ForeName': 'Wenfeng', 'Initials': 'W', 'LastName': 'Guan', 'Affiliation': ""People's Hospital of Yangjiang, Urology, 42 Dongshan Road, Jiangchen District, Yangjiang, Guangdong, China, Yangjiang, Guangdong, China, 529500; 445308317@qq.com.""}, {'ForeName': 'Shubo', 'Initials': 'S', 'LastName': 'Fan', 'Affiliation': 'Department of Urology, Peking University First Hospital. Institute of Urology, Peking University. National Urological Cancer Center, Beijing, China; 18801212902@163.com.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Liang', 'Affiliation': ""People's Hospital of Yangjiang, Urology, Yangjiang, Guangdong, China; 2434935259@qq.com.""}, {'ForeName': 'Nengzhuo', 'Initials': 'N', 'LastName': 'Feng', 'Affiliation': ""People's Hospital of Yangjiang, Urology, Yangjiang, Guangdong, China; 13680650688@163.com.""}, {'ForeName': 'Qiyan', 'Initials': 'Q', 'LastName': 'Liang', 'Affiliation': ""People's Hospital of Yangjiang, Urology, Yangjiang, Guangdong, China; 154243452@qq.com.""}, {'ForeName': 'Yixin', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': ""People's Hospital of Yangjiang, Urology, Yangjiang, Guangdong, China; 495011309@qq.com.""}, {'ForeName': 'Wenchao', 'Initials': 'W', 'LastName': 'Qin', 'Affiliation': ""People's Hospital of Yangjiang, Urology, Yangjiang, Guangdong, China; 494579092@qq.com.""}, {'ForeName': 'Jingwei', 'Initials': 'J', 'LastName': 'He', 'Affiliation': ""People's Hospital of Yangjiang, Urology, Yangjiang, Guangdong, China; windy_19@163.com.""}, {'ForeName': 'Kunlin', 'Initials': 'K', 'LastName': 'Yang', 'Affiliation': 'Peking University First Hospital, 26447, Department of Urology, Beijing, Beijing, China; yangkunlin12345@163.com.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Xie', 'Affiliation': ""People's Hospital of Yangjiang, Urology, Yangjiang, Guangdong, China; 13926366112@139.com.""}, {'ForeName': 'Xuesong', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Peking University First Hospital, Urology, NO.8 Xi Shi Ku St., Xicheng District, Beijing, China, 100034; pineneedle@sina.com.'}]",Journal of endourology,['10.1089/end.2020.0296'] 2676,31834410,Effectiveness of adding a workplace intervention to an inpatient multimodal occupational rehabilitation program: A randomized clinical trial.,"Objectives This study aimed to evaluate the effectiveness of a workplace intervention (WI) added to an inpatient multimodal occupational rehabilitation program (I-MORE) on sickness absence. Methods In this researcher-blinded randomized controlled trial with parallel groups, individuals on sick leave due to musculoskeletal, unspecified- or common mental health disorders were randomized to I-MORE (N=87) or I-MORE+WI (N=88). I-MORE lasted 2+1 weeks (with one week at home in between) and consisted of ""acceptance and commitment therapy"", physical exercise, and work-related problem solving. The additional WI consisted of a preparatory part, a workplace meeting involving the sick-listed worker, the employer, and the primary rehabilitation therapist at the rehabilitation center, and follow-up work related to the meeting. The primary outcomes were number of sickness absence days and time until sustainable return to work (RTW) during 12 months of follow-up, measured by registry data. Results The median number of sickness absence days during the 12-month follow-up for I-MORE was 115 days [interquartile range (IQR) 53-183] versus 130 days (IQR 81-212) for I-MORE+WI. The difference between groups was not statistically significant (P=0.084). The hazard ratio for sustainable RTW was 0.74 (95% confidence interval 0.48-1.16; P=0.192) in favor of I-MORE. Conclusions This study provided no evidence in favor of I-MORE+WI compared to only I-MORE for long-term sickness absent individuals with musculoskeletal-, common mental- or unspecified disorders.",2020,The hazard ratio for sustainable RTW was 0.74 (95% confidence interval 0.48-1.16; P=0.192) in favor of I-MORE.,"['individuals on sick leave due to musculoskeletal, unspecified- or common mental health disorders']","['workplace intervention', 'workplace intervention (WI) added to an inpatient multimodal occupational rehabilitation program (I-MORE', 'acceptance and commitment therapy"", physical exercise, and work-related problem solving']","['hazard ratio for sustainable RTW', 'number of sickness absence days and time until sustainable return to work (RTW', 'sickness absence', 'median number of sickness absence days']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0242807', 'cui_str': 'Sick Leave'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0205370', 'cui_str': 'Non-specific'}, {'cui': 'C0205214', 'cui_str': 'Common'}, {'cui': 'C0004936', 'cui_str': 'Mental disorder'}]","[{'cui': 'C0162579', 'cui_str': 'Work environment'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0521127', 'cui_str': 'Occupational'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}, {'cui': 'C3658321', 'cui_str': 'Acceptance and commitment therapy'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0043227', 'cui_str': 'Working'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0033211', 'cui_str': 'Problem solving'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0425105', 'cui_str': 'Returned to work'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",,0.138213,The hazard ratio for sustainable RTW was 0.74 (95% confidence interval 0.48-1.16; P=0.192) in favor of I-MORE.,"[{'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Skagseth', 'Affiliation': 'Norwegian University of Science and Technology, Faculty of Medicine and Health Sciences, Department of Public Health and Nursing, Postboks 8905, 7491 Trondheim, Norway. mskagseth@gmail.com.'}, {'ForeName': 'Marius S', 'Initials': 'MS', 'LastName': 'Fimland', 'Affiliation': ''}, {'ForeName': 'Marit B', 'Initials': 'MB', 'LastName': 'Rise', 'Affiliation': ''}, {'ForeName': 'Roar', 'Initials': 'R', 'LastName': 'Johnsen', 'Affiliation': ''}, {'ForeName': 'Petter C', 'Initials': 'PC', 'LastName': 'Borchgrevink', 'Affiliation': ''}, {'ForeName': 'Lene', 'Initials': 'L', 'LastName': 'Aasdahl', 'Affiliation': ''}]","Scandinavian journal of work, environment & health",['10.5271/sjweh.3873'] 2677,32611327,Postoperative adjuvant treatment strategy for hepatocellular carcinoma with microvascular invasion: a non-randomized interventional clinical study.,"BACKGROUND Microvascular invasion (MVI) is considered to be one of the important prognostic factors that affect postoperative recurrence in patients with hepatocellular carcinoma (HCC) with variable results across their treatment options. This study was carried out to investigate efficacy of postoperative adjuvant RT in HCC patients with MVI. METHODS This was single center, prospective study carried out in HCC patients with MVI, aged 35-72 years. All patients were non-randomly allocated to receive standard postoperative treatment of HBV/HCV and nutritional therapy or RT in addition to standard postoperative treatment (1:1). The primary endpoints assessed were relapse-free survival and overall survival. The prognostic factors associated with survival outcomes were also analyzed. The safety events were graded according to NCI-CTCAE v4.03 criteria. RESULTS Of the 115 patients eligible for study, 59 patients were included in analysis. Univariate analysis revealed that MVI classification (P = 0.009), post-operative treatment strategies (P = 0.009) were prognostic factors for worst RFS; tumor size (P = 0.011), MVI classification (P = 0.005) and post-operative treatment (P = 0.015) were associated for OS. The 1-, 2-, 3-year RFS rates were 86.2, 70.5 and 63.4% for patients in RT group, and 46.4, 36.1, and 36.1% in control group. For OS, corresponding rates were 96.6, 80.7, and 80.7% for patients in RT group and 79.7, 58.3, and 50.0% in control group. Subgroup classification of HCC patients according to low risk MVI showed significantly longer RFS (P = 0.035) and OS (P = 0.004) in RT group than control group, while for high risk MVI, RT depicted longer OS than control group with no significance (P = 0.106). Toxicities were usually observed in acute stage with no grade 4 toxicities. CONCLUSION Postoperative adjuvant RT following hepatectomy offers better RFS for HCC patients with MVI than with standard postoperative therapy. Also, it will be useful to control microscopic lesions in both M1 (low risk) and M2 (high risk) subgroups of HCC patients with MVI. TRIAL REGISTRATION Trial Registration number: ChiCTR1800017371 . Date of Registration: 2018-07-26. Registration Status: Retrospectively registered.",2020,"Subgroup classification of HCC patients according to low risk MVI showed significantly longer RFS (P = 0.035) and OS (P = 0.004) in RT group than control group, while for high risk MVI, RT depicted longer OS than control group with no significance (P = 0.106).","['HCC patients with MVI, aged 35-72\u2009years', 'hepatocellular carcinoma with microvascular invasion', '115 patients eligible for study', 'patients with hepatocellular carcinoma (HCC', 'HCC patients with MVI than with standard postoperative therapy', 'HCC patients with MVI', '59 patients were included in analysis']",['standard postoperative treatment of HBV/HCV and nutritional therapy or RT'],"['MVI classification', 'relapse-free survival and overall survival', '3-year RFS rates', 'Toxicities', 'RFS', 'survival outcomes']","[{'cui': 'C2239176', 'cui_str': 'Hepatocellular carcinoma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0443258', 'cui_str': 'Microvascular'}, {'cui': 'C1269955', 'cui_str': 'Tumour invasion'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517540', 'cui_str': '115'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0019163', 'cui_str': 'Type B viral hepatitis'}, {'cui': 'C0019196', 'cui_str': 'Viral hepatitis C'}, {'cui': 'C0242739', 'cui_str': 'Nutritional support'}]","[{'cui': 'C0443258', 'cui_str': 'Microvascular'}, {'cui': 'C1269955', 'cui_str': 'Tumour invasion'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0341703', 'cui_str': 'Adult Fanconi syndrome'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",59.0,0.073244,"Subgroup classification of HCC patients according to low risk MVI showed significantly longer RFS (P = 0.035) and OS (P = 0.004) in RT group than control group, while for high risk MVI, RT depicted longer OS than control group with no significance (P = 0.106).","[{'ForeName': 'Liming', 'Initials': 'L', 'LastName': 'Wang', 'Affiliation': 'Department of Hepatobiliary Surgery, National Cancer Center/ National Clinical Research Center for Cancer/ Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, 17 Panjiayuan Nanli Area, Chaoyang District, Beijing, 100021, China.'}, {'ForeName': 'Weihu', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'Department of Radiation Oncology, Key laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Peking University Cancer Hospital & Institute, 52 Fucheng Rd, Haidian District, Beijing, 100142, China.'}, {'ForeName': 'Weiqi', 'Initials': 'W', 'LastName': 'Rong', 'Affiliation': 'Department of Hepatobiliary Surgery, National Cancer Center/ National Clinical Research Center for Cancer/ Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, 17 Panjiayuan Nanli Area, Chaoyang District, Beijing, 100021, China.'}, {'ForeName': 'Zhuo', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Department of Pathology, National Cancer Center/ National Clinical Research Center for Cancer /Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, 17 Panjiayuan Nanli Area, Chaoyang District, Beijing, 100021, China.'}, {'ForeName': 'Fan', 'Initials': 'F', 'LastName': 'Wu', 'Affiliation': 'Department of Hepatobiliary Surgery, National Cancer Center/ National Clinical Research Center for Cancer/ Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, 17 Panjiayuan Nanli Area, Chaoyang District, Beijing, 100021, China.'}, {'ForeName': 'Yunhe', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Hepatobiliary Surgery, National Cancer Center/ National Clinical Research Center for Cancer/ Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, 17 Panjiayuan Nanli Area, Chaoyang District, Beijing, 100021, China.'}, {'ForeName': 'Yiling', 'Initials': 'Y', 'LastName': 'Zheng', 'Affiliation': 'Department of Hepatobiliary Surgery, National Cancer Center/ National Clinical Research Center for Cancer/ Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, 17 Panjiayuan Nanli Area, Chaoyang District, Beijing, 100021, China.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Zhang', 'Affiliation': 'Department of Hepatobiliary Surgery, National Cancer Center/ National Clinical Research Center for Cancer/ Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, 17 Panjiayuan Nanli Area, Chaoyang District, Beijing, 100021, China.'}, {'ForeName': 'Tana', 'Initials': 'T', 'LastName': 'Siqin', 'Affiliation': 'Department of Hepatobiliary Surgery, National Cancer Center/ National Clinical Research Center for Cancer/ Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, 17 Panjiayuan Nanli Area, Chaoyang District, Beijing, 100021, China.'}, {'ForeName': 'Mei', 'Initials': 'M', 'LastName': 'Liu', 'Affiliation': 'Laboratory of Cell and Molecular Biology & State Key Laboratory of Molecular Oncology, National Cancer Center/ National Clinical Research Center for Cancer /Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, 17 Panjiayuan Nanli Area, Chaoyang District, Beijing, 100021, China.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Chen', 'Affiliation': 'Department of Radiation Oncology, National Cancer Center/ National Clinical Research Center for Cancer /Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, 17 Panjiayuan Nanli Area, Chaoyang District, Beijing, 100021, China. chenboo@outlook.com.'}, {'ForeName': 'Jianxiong', 'Initials': 'J', 'LastName': 'Wu', 'Affiliation': 'Department of Hepatobiliary Surgery, National Cancer Center/ National Clinical Research Center for Cancer/ Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, 17 Panjiayuan Nanli Area, Chaoyang District, Beijing, 100021, China. dr.wujx@hotmail.com.'}]",BMC cancer,['10.1186/s12885-020-07087-7'] 2678,32611377,"The I-MICRO trial, Ilomedin for treatment of septic shock with persistent microperfusion defects: a double-blind, randomized controlled trial-study protocol for a randomized controlled trial.","BACKGROUND Septic shock remains a significant cause of death in critically ill patients. During septic shock, some patients will retain microcirculatory disorders despite optimal hemodynamic support (i.e., fluid resuscitation, vasopressors, inotropes). Alterations in the microcirculation are a key pathophysiological factor of organ dysfunction and death in septic shock patients. Ilomedin is a prostacyclin analog with vasodilatory effect and anti-thrombotic properties (i.e., inhibition of platelet aggregation) preferentially at the microcirculatory level. We hypothesize that early utilization of intravenous Ilomedin in septic shock patients with clinical persistence of microperfusion disorders would improve the recovery of organ dysfunction. METHODS The I-MICRO trial is a multicenter, prospective, randomized, double-blinded, placebo-controlled study. We plan to recruit 236 adult patients with septic shock and persistent microcirculatory disorders (i.e., skin mottling or increased capillary refill time) despite hemodynamic support. Participants will be randomized to receive a 48-h intravenous infusion of either Ilomedin or placebo starting at the earliest 6 h and later 24 h after septic shock. The primary outcome will be the change (delta) of sequential organ failure assessment (SOFA) score between randomization and day 7. Secondary outcomes will include mean SOFA score during the first 7 days after randomization, mortality at day 28 post-randomization, number of ventilation-free survival days in the 28 days post-randomization, number of renal replacement therapy-free survival days in the 28 days post-randomization, number of vasopressor-free survival days in the 28 days post-randomization, and mottling score at day 1 after randomization. DISCUSSION The trial aims to provide evidence on the efficacy and safety of Ilomedin in patients with septic shock and persistent microcirculatory disorders. TRIAL REGISTRATION NCT NCT03788837 . Registered on 28 December 2018.",2020,The primary outcome will be the change (delta) of sequential organ failure assessment (SOFA) score between randomization and day 7.,"['septic shock patients with clinical persistence of microperfusion disorders', 'septic shock patients', 'critically ill patients', '236 adult patients with septic shock and persistent microcirculatory disorders (i.e., skin mottling or increased capillary refill time) despite hemodynamic support', 'septic shock with persistent microperfusion defects', 'patients with septic shock and persistent microcirculatory disorders']","['placebo', 'intravenous Ilomedin', 'Ilomedin or placebo', 'Ilomedin']","['number of vasopressor-free survival days', 'change (delta) of sequential organ failure assessment (SOFA) score', 'mean SOFA score during the first 7\xa0days after randomization, mortality at day 28 post-randomization, number of ventilation-free survival days', 'number of renal replacement therapy-free survival days', 'efficacy and safety']","[{'cui': 'C0036983', 'cui_str': 'Septic shock'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0546816', 'cui_str': 'Persistence'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0302133', 'cui_str': 'Mottling'}, {'cui': 'C0232359', 'cui_str': 'Increased capillary filling time'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0243067', 'cui_str': 'defects'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}]","[{'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0042397', 'cui_str': 'Vasoconstrictor agent'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0349410', 'cui_str': 'Single organ dysfunction'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C3494459', 'cui_str': 'Sequential organ failure assessment score'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0206074', 'cui_str': 'Renal replacement therapy'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",236.0,0.774087,The primary outcome will be the change (delta) of sequential organ failure assessment (SOFA) score between randomization and day 7.,"[{'ForeName': 'Matthieu', 'Initials': 'M', 'LastName': 'Legrand', 'Affiliation': 'Department of Anaesthesiology, Critical Care Medicine and Burn Unit, AP-HP, Saint Louis and Lariboisière University Hospitals, 2 rue A. Paré, 75010, Paris, France. Matthieu.legrand@ucsf.edu.'}, {'ForeName': 'Hafid Ait', 'Initials': 'HA', 'LastName': 'Oufella', 'Affiliation': 'Assistance Publique - Hôpitaux de Paris (AP-HP), Hôpital Saint-Antoine, Service de Réanimation Médicale, 75571, Paris Cedex 12, France.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'De Backer', 'Affiliation': 'Intensive Care Department, CHIREC Hospitals, Université Libre de Bruxelles, Brussels, Belgium.'}, {'ForeName': 'Jacques', 'Initials': 'J', 'LastName': 'Duranteau', 'Affiliation': 'Department of Anesthesia and Intensive Care, Hôpitaux Universitaires Paris Sud, Université Paris Sud XI, Le Kremlin Bicêtre, France.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Leone', 'Affiliation': ""Aix Marseille Université, Assistance Publique Hôpitaux de Marseille, Service d'Anesthésie et de Réanimation, Hôpital Nord, Marseille, France.""}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Levy', 'Affiliation': 'Service de Réanimation Médicale, Centre Hospitalo-Universitaire de Nancy, F-54511, Vandœuvre-Lès-Nancy, France.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Rossignol', 'Affiliation': ""Centre d'Investigation Clinique Plurithématique Pierre Drouin-INSERM CHU de Nancy, Nancy, France.""}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Vicaut', 'Affiliation': 'APHP, Department of Biostatistics, Université Paris-Diderot, Sorbonne-Paris Cité, Fernand Widal Hospital, Paris, France.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Dépret', 'Affiliation': 'Department of Anaesthesiology, Critical Care Medicine and Burn Unit, AP-HP, Saint Louis and Lariboisière University Hospitals, 2 rue A. Paré, 75010, Paris, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Trials,['10.1186/s13063-020-04549-y'] 2679,32611442,"Effect of voluntary breathing exercises on stable coronary artery disease in heart rate variability and rate-pressure product: a study protocol for a single-blind, prospective, randomized controlled trial.","BACKGROUND At present, China has more than 11 million patients with stable coronary heart disease and this is becoming a major public health problem. The pathological changes of coronary heart disease can lead to dysfunction of the cardiac autonomic nervous system, which increases the risk of complications such as malignant arrhythmia (ventricular flutter, ventricular fibrillation, etc.), heart rate, systolic blood pressure, and rate-pressure product (RPP), which is highly correlated with myocardial oxygen consumption and indirectly reflects myocardial blood supply and oxygen consumption. Although the guidelines recommend that such patients take drugs to reduce heart rate and myocardial oxygen consumption, the clinical control of heart rate is still not ideal. Thus, in this trial, we will use voluntary breathing exercises as the strategy of exercise rehabilitation for patients with stable coronary artery disease (SCAD), in order to increase the vagus nerve activity and/or reduce the sympathetic nervous activity, help maintain or rebuild the balance of plant nerve system, improve the time-domain index of heart rate variability, reduce the burden on the heart, and relieve patients' anxiety and other negative emotions. METHODS This is a 6-month single-blind, randomized controlled clinical trial that will be conducted in the First Affiliated Hospital of Soochow University. A total of 140 patients who fill out the Informed Consent Form are registered and randomized 1:1 into the Voluntary Breathing Exercises (VBE)-based clinical trial monitoring group (n = 70) or the Routine follow-up group (n = 70). The VBE-based clinical trial monitoring group is given VBE training on the basis of conventional treatment and health education, while the control group received conventional health education and follow-up. The primary outcomes will be measured heart rate variability and RPP. Secondary outcomes will include changes in Self-rating Anxiety Scale, total cholesterol, triglyceride, high-density lipoprotein, low-density lipoprotein, weight, and body mass index. DISCUSSION This trial will carry out scientific respiratory exercise for patients with SCAD, which belongs to the category of active secondary prevention for patients, and changes from remedial to pre-protective. VBE is easy to operate and is not limited by time and place. It is important and meaningful to carry out VBE for patients with SCAD. This study will provide considerable evidence for further large-scale trials and alternative strategies for the rehabilitation nursing of patients with SCAD. TRIAL REGISTRATION Chinese Clinical Trials Registry, 1900024043 . Registered on 23 June 2019.",2020,"This study will provide considerable evidence for further large-scale trials and alternative strategies for the rehabilitation nursing of patients with SCAD. ","['First Affiliated Hospital of Soochow University', 'patients with stable coronary artery disease (SCAD', 'patients with SCAD', '11 million patients with stable coronary heart disease', '140 patients who fill out the Informed Consent Form are registered and randomized 1:1 into the']","['Voluntary Breathing Exercises (VBE)-based clinical trial monitoring group (n\xa0=\u200970) or the Routine follow-up group', 'voluntary breathing exercises', 'VBE', 'VBE training']","['changes in Self-rating Anxiety Scale, total cholesterol, triglyceride, high-density lipoprotein, low-density lipoprotein, weight, and body mass index', 'heart rate, systolic blood pressure, and rate-pressure product (RPP', 'heart rate and myocardial oxygen consumption', 'heart rate variability and RPP']","[{'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C1881839', 'cui_str': '1000000'}, {'cui': 'C4319553', 'cui_str': '140'}, {'cui': 'C0009797', 'cui_str': 'Informed Consent Forms'}, {'cui': 'C0600375', 'cui_str': 'Registers'}]","[{'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0023823', 'cui_str': 'Low density lipoprotein'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0428863', 'cui_str': 'Myocardial oxygen consumption'}]",140.0,0.0504461,"This study will provide considerable evidence for further large-scale trials and alternative strategies for the rehabilitation nursing of patients with SCAD. ","[{'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Wu', 'Affiliation': 'Department of Cardiology, The First Affiliated Hospital of Soochow University, Suzhou, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Department of Cardiology, The First Affiliated Hospital of Soochow University, Suzhou, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Jiang', 'Affiliation': ""Nursing Department, Wuxi People's Hospital, Wuxi, China.""}, {'ForeName': 'Yao-Yao', 'Initials': 'YY', 'LastName': 'Hu', 'Affiliation': 'School of nursing, Soochow University, Suzhou, China.'}, {'ForeName': 'Qiu-Shi', 'Initials': 'QS', 'LastName': 'Liang', 'Affiliation': 'School of nursing, Soochow University, Suzhou, China.'}, {'ForeName': 'Zhi-Song', 'Initials': 'ZS', 'LastName': 'He', 'Affiliation': 'Department of Cardiology, The First Affiliated Hospital of Soochow University, Suzhou, China.'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Xue', 'Affiliation': 'School of nursing, Soochow University, Suzhou, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Zhu', 'Affiliation': 'Electrocardiographic room, The First Affiliated Hospital of Soochow University, Suzhou, China.'}, {'ForeName': 'Zai-Xiang', 'Initials': 'ZX', 'LastName': 'Tang', 'Affiliation': 'School of Public Health, Soochow University, Suzhou, China.'}, {'ForeName': 'Yun-Ying', 'Initials': 'YY', 'LastName': 'Hou', 'Affiliation': 'Department of Cardiology, The First Affiliated Hospital of Soochow University, Suzhou, China.'}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Zhao', 'Affiliation': 'Department of Radiotherapy, The First Affiliated Hospital of Soochow University, Suzhou, China. 734867417@qq.com.'}, {'ForeName': 'Xiao-Hua', 'Initials': 'XH', 'LastName': 'Wang', 'Affiliation': 'Department of Cardiology, The First Affiliated Hospital of Soochow University, Suzhou, China. 648650801@qq.com.'}]",Trials,['10.1186/s13063-020-04402-2'] 2680,32611445,"TILT: Time-Lapse Imaging Trial-a pragmatic, multi-centre, three-arm randomised controlled trial to assess the clinical effectiveness and safety of time-lapse imaging in in vitro fertilisation treatment.","BACKGROUND Subfertility is a common problem for which in vitro fertilisation (IVF) treatment is commonly recommended. Success rates following IVF are suboptimal and have remained static over the last few years. This imposes a considerable financial burden on overstretched healthcare resources. Time-lapse imaging (TLI) of developing embryos in IVF treatment is hypothesised to improve the success rates of treatment. This may be either by providing undisturbed culture conditions or by improving the predictive accuracy for optimal embryo selection from a cohort of available embryos. However, the current best evidence for its effectiveness is inconclusive. METHODS The time-lapse imaging trial is a pragmatic, multi-centre, three-arm parallel-group randomised controlled trial using re-randomisation. The primary objective of the trial is to determine if the use of TLI or undisturbed culture in IVF treatment results in a higher live birth rate when compared to current standard methods of embryo incubation and assessment. Secondary outcomes include measures of clinical efficacy and safety. The trial will randomise 1575 participants to detect an increase in live birth from 26.5 to 35.25%. DISCUSSION In the absence of high-quality evidence, there is no current national guidance, recommendation or policy for the use of TLI. The use of TLI is not consistently incorporated into standard IVF care. A large, pragmatic, multi-centre, trial will provide much needed definitive evidence regarding the effectiveness of TLI. If proven to be effective, its incorporation into standard care would translate into significant clinical and economic benefits. If not, it would allow allocation of resources to more effective interventions. TRIAL REGISTRATION ISRCTN registry ISRCTN17792989 . Prospectively registered on 18 April 2018.",2020,Time-lapse imaging (TLI) of developing embryos in IVF treatment is hypothesised to improve the success rates of treatment.,['Prospectively registered on 18 April 2018'],['TLI'],"['live birth', 'Time-lapse imaging (TLI', 'live birth rate', 'clinical efficacy and safety']","[{'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}]","[{'cui': 'C2936618', 'cui_str': 'Time-Lapsed Imaging'}]","[{'cui': 'C0481667', 'cui_str': 'Live birth'}, {'cui': 'C2936618', 'cui_str': 'Time-Lapsed Imaging'}, {'cui': 'C0087113', 'cui_str': 'Clinical Efficacy'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.281877,Time-lapse imaging (TLI) of developing embryos in IVF treatment is hypothesised to improve the success rates of treatment.,"[{'ForeName': 'Priya', 'Initials': 'P', 'LastName': 'Bhide', 'Affiliation': ""Barts Research Centre for Women's Health, Institute of Population Health Sciences, Queen Mary University of London, London, UK. p.bhide@qmul.ac.uk.""}, {'ForeName': 'Arasaratnam', 'Initials': 'A', 'LastName': 'Srikantharajah', 'Affiliation': 'Homerton Fertility Centre, Homerton University Hospital, London, UK.'}, {'ForeName': 'Doris', 'Initials': 'D', 'LastName': 'Lanz', 'Affiliation': ""Barts Research Centre for Women's Health, Institute of Population Health Sciences, Queen Mary University of London, London, UK.""}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Dodds', 'Affiliation': ""Barts Research Centre for Women's Health, Institute of Population Health Sciences, Queen Mary University of London, London, UK.""}, {'ForeName': 'Bonnie', 'Initials': 'B', 'LastName': 'Collins', 'Affiliation': ""Centre for Reproductive Medicine, St Bartholomew's Hospital, London, UK.""}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Zamora', 'Affiliation': ""Barts Research Centre for Women's Health, Institute of Population Health Sciences, Queen Mary University of London, London, UK.""}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Chan', 'Affiliation': 'Assisted Reproductive Technology Unit, Department of Obstetrics and Gynaecology, Faculty of Medicine, The Chinese University of Hong Kong, Sha Tin, Hong Kong SAR.'}, {'ForeName': 'Shakila', 'Initials': 'S', 'LastName': 'Thangaratinam', 'Affiliation': ""Institute of Metabolism and Systems Research, WHO Collaborating Centre for Women's Health, University of Birmingham, Birmingham, UK.""}, {'ForeName': 'Khalid S', 'Initials': 'KS', 'LastName': 'Khan', 'Affiliation': 'Department of Preventive Medicine and Public Health, University of Granada, Granada, Spain.'}]",Trials,['10.1186/s13063-020-04537-2'] 2681,32611448,Esophagectomy versus definitive chemoradiotherapy for patients with clinical stage N0 and pathological stage T1b esophageal squamous cell carcinoma after endoscopic submucosal dissection: study protocol for a multicenter randomized controlled trial (Ad-ESD Trial).,"BACKGROUND Esophagectomy is still advised as an additional treatment for pathological T1b (pT1b) esophageal squamous cell carcinoma (ESCC) following attempted endoscopic resection (ER). ER followed with definitive chemoradiotherapy (dCRT) has shown increased quality of life as well as comparable oncological outcomes to esophagectomy. However, there is no well-designed phase III trial to compare the two treatments for patients with pT1b ESCC. METHODS One hundred seventy-six patients with clinical stage N0 (cN0) and pT1b ESCC will be recruited at three centers and randomly assigned to the esophagectomy group or the dCRT group. The clinical lymph node status will be measured by image examination, including computer tomography and positron emission tomography-computed tomography. The pathological tumor status will be diagnosed after endoscopic submucosal dissection (ESD). All patients will be followed up for 60 months after randomization. The primary endpoint is 5-year overall survival. The secondary endpoints are quality of life, related adverse events, 3-year overall survival, and relapse-free survival rates. DISCUSSION To the best of our knowledge, this is the first phase III randomized controlled trial to compare esophagectomy and dCRT for patients with cN0-pT1b ESCC after ESD. Based on the results of this study, we will show whether dCRT will benefit patients more than esophagectomy, which will contribute more high-quality evidence to the primary salvage treatment for these patients. TRIAL REGISTRATION ClinicalTrials.gov, NCT04135664 . Registered on Aug. 10, 2019.",2020,"The secondary endpoints are quality of life, related adverse events, 3-year overall survival, and relapse-free survival rates. ","['patients with clinical stage N0 and pathological stage T1b esophageal squamous cell carcinoma after endoscopic submucosal dissection', 'pathological T1b (pT1b) esophageal squamous cell carcinoma (ESCC) following attempted endoscopic resection (ER', 'One hundred seventy-six patients with clinical stage N0 (cN0) and pT1b ESCC will be recruited at three centers', 'patients with pT1b ESCC', 'patients with cN0-pT1b ESCC after ESD']","['ER followed with definitive chemoradiotherapy (dCRT', 'esophagectomy and dCRT', 'Esophagectomy versus definitive chemoradiotherapy', 'esophagectomy group or the dCRT', 'dCRT']","['quality of life', '5-year overall survival', 'quality of life, related adverse events, 3-year overall survival, and relapse-free survival rates']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205563', 'cui_str': 'Clinical stage finding'}, {'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0475385', 'cui_str': 'Tumor stage T1b'}, {'cui': 'C0279626', 'cui_str': 'Squamous cell carcinoma of esophagus'}, {'cui': 'C1700929', 'cui_str': 'Endoscopic Submucosal Dissection'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C4319622', 'cui_str': '76'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0443196', 'cui_str': 'Definitive'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0085198', 'cui_str': 'Esophagectomy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}]",176.0,0.253509,"The secondary endpoints are quality of life, related adverse events, 3-year overall survival, and relapse-free survival rates. ","[{'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Department of Thoracic Surgery, Shanghai Chest Hospital, Shanghai Jiao Tong University, No.241 West Huaihai Road, Shanghai, 200030, China.'}, {'ForeName': 'Yuchen', 'Initials': 'Y', 'LastName': 'Su', 'Affiliation': 'Department of Endoscopy, Shanghai Chest Hospital, Shanghai Jiao Tong University, No.241 West Huaihai Road, Shanghai, 200030, China.'}, {'ForeName': 'Xiaobin', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Department of Thoracic Surgery, Shanghai Chest Hospital, Shanghai Jiao Tong University, No.241 West Huaihai Road, Shanghai, 200030, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': 'Department of Radiation Oncology, Shanghai Chest Hospital, Shanghai Jiao Tong University, No.241 West Huaihai Road, Shanghai, 200030, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Department of Endoscopy, Shanghai Chest Hospital, Shanghai Jiao Tong University, No.241 West Huaihai Road, Shanghai, 200030, China.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Li', 'Affiliation': 'Department of Thoracic Surgery, Shanghai Chest Hospital, Shanghai Jiao Tong University, No.241 West Huaihai Road, Shanghai, 200030, China.'}, {'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Hua', 'Affiliation': 'Department of Thoracic Surgery, Shanghai Chest Hospital, Shanghai Jiao Tong University, No.241 West Huaihai Road, Shanghai, 200030, China.'}, {'ForeName': 'Lijie', 'Initials': 'L', 'LastName': 'Tan', 'Affiliation': 'Department of Thoracic Surgery, Zhongshan Hospital, Fudan University, No. 180 Fenglin Road, Shanghai, 200032, China.'}, {'ForeName': 'Hezhong', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'Department of Thoracic Surgery, Changhai Hospital, Naval Military Medical University, No. 168 Changhai Road, Shanghai, 200433, China.'}, {'ForeName': 'Zhigang', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Department of Thoracic Surgery, Shanghai Chest Hospital, Shanghai Jiao Tong University, No.241 West Huaihai Road, Shanghai, 200030, China. zhigang_li_sch@163.com.'}]",Trials,['10.1186/s13063-020-04461-5'] 2682,32611648,"A biomarker-enriched, randomized Phase II trial of adavosertib (AZD1775) plus paclitaxel and carboplatin for women with platinum-sensitive TP53 -mutant ovarian cancer.","PURPOSE Preclinical studies show that adavosertib, a WEE1 kinase inhibitor, sensitizes TP53 -mutant cells to chemotherapy. We hypothesized that adavosertib, plus chemotherapy, would enhance efficacy versus placebo in TP53 -mutated ovarian cancer. METHODS Following safety run-in, this double-blind Phase II trial (NCT01357161) randomized women with TP53 -mutated, platinum-sensitive ovarian cancer to oral adavosertib (225 mg twice daily for 2.5 days/21-day cycle) or placebo, plus carboplatin (AUC5) and paclitaxel (175 mg/m 2 ), until disease progression or for six cycles. The primary endpoints were progression-free survival (PFS) by enhanced RECIST v1.1 (ePFS [volumetric]) and safety. Secondary/exploratory objectives included PFS by RECIST v1.1 (single dimension), objective response rate, overall survival, and analysis of tumor gene profile versus sensitivity to adavosertib. RESULTS 121 patients were randomized to adavosertib (A+C; n=59) and placebo (P+C; n=62) plus chemotherapy. Adding adavosertib to chemotherapy improved ePFS (median: 7.9 [95% CI 6.9-9.9] vs 7.3 months [5.6-8.2]; HR 0.63 [95% CI 0.38-1.06]; two-sided P =0.080), meeting the predefined significance threshold ( P <0.2). Clinical benefit was observed following A+C for patients with different TP53 mutation subtypes, identifying possible response biomarkers. An increase in adverse events was seen with A+C versus P+C: greatest for diarrhea (adavosertib 75%; placebo 37%), vomiting (63%; 27%), anemia (53%; 32%), and all grade ≥3 adverse events (78%; 65%). CONCLUSIONS Establishing an optimal strategy for managing tolerability and identifying specific patient populations most likely to benefit from treatment may increase clinical benefit. Future studies should consider additional adavosertib doses within the chemotherapy treatment cycle and the potential for maintenance therapy.",2020,An increase in adverse events was seen with A+C versus P+C: greatest for diarrhea,"['women with platinum-sensitive TP53 -mutant ovarian cancer', '121 patients', 'women with TP53 -mutated, platinum-sensitive ovarian cancer to oral adavosertib (225 mg twice daily for 2.5 days/21-day cycle) or']","['adavosertib, plus chemotherapy', 'adavosertib (AZD1775) plus paclitaxel and carboplatin', 'placebo (P+C; n=62) plus chemotherapy', 'adavosertib (A+C', 'placebo, plus carboplatin (AUC5) and paclitaxel', 'placebo']","['diarrhea', 'progression-free survival (PFS) by enhanced RECIST v1.1 (ePFS [volumetric]) and safety', 'PFS by RECIST v1.1 (single dimension), objective response rate, overall survival, and analysis of tumor gene profile versus sensitivity to adavosertib', 'grade ≥3 adverse events', 'vomiting', 'anemia', 'adverse events', 'ePFS']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032207', 'cui_str': 'Platinum'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0079419', 'cui_str': 'Genes, TP53'}, {'cui': 'C0919267', 'cui_str': 'Neoplasm of ovary'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C4517652', 'cui_str': '225'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C3844011', 'cui_str': '2.5'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C1709926', 'cui_str': 'RECIST'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}]",121.0,0.652253,An increase in adverse events was seen with A+C versus P+C: greatest for diarrhea,"[{'ForeName': 'Amit M', 'Initials': 'AM', 'LastName': 'Oza', 'Affiliation': 'Division of Medical Oncology & Hematology, Bras Family Drug Development Program, Princess Margaret Cancer Centre amit.oza@uhn.ca.'}, {'ForeName': 'Maria D P', 'Initials': 'MDP', 'LastName': 'Estevez-Diz', 'Affiliation': 'Radiology and Oncology, Instituto do Cancer do Estado de Sao Paulo/Faculdade de Medicina da Universidade de Sao Paulo.'}, {'ForeName': 'Eva-Maria', 'Initials': 'EM', 'LastName': 'Grischke', 'Affiliation': 'Universitӓts Frauenklinik Tubingen, Eberhard Karls University.'}, {'ForeName': 'Marcia', 'Initials': 'M', 'LastName': 'Hall', 'Affiliation': 'Medical Oncology, Mount Vernon Cancer Centre.'}, {'ForeName': 'Frederik', 'Initials': 'F', 'LastName': 'Marmé', 'Affiliation': 'Department of Gynecologic Oncology, Medical Faculty Mannheim, Heidelberg University.'}, {'ForeName': 'Diane M', 'Initials': 'DM', 'LastName': 'Provencher', 'Affiliation': ""Institut du Cancer de Montréal, Centre de Recherche du Centre Hospitalier de l'Université de Montréal.""}, {'ForeName': 'Denise S', 'Initials': 'DS', 'LastName': 'Uyar', 'Affiliation': 'Department of Obstetrics and Gynecology, Medical College of Wisconsin.'}, {'ForeName': 'Johanne I', 'Initials': 'JI', 'LastName': 'Weberpals', 'Affiliation': 'Department of Obstetrics and Gynecology, division of Gynecologic Oncology, Ottawa Hospital.'}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Wenham', 'Affiliation': 'Gynecologic Oncology and Chemical Biology and Molecular Medicine, Moffitt Cancer Center.'}, {'ForeName': 'Naomi', 'Initials': 'N', 'LastName': 'Laing', 'Affiliation': 'Oncology Development, Bristol-Myers Squibb (United States).'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Tracy', 'Affiliation': 'GMD, AstraZeneca.'}, {'ForeName': 'Tomoko', 'Initials': 'T', 'LastName': 'Freshwater', 'Affiliation': 'RESEARCH, Merck & Co., Inc.'}, {'ForeName': 'Mark Anthony', 'Initials': 'MA', 'LastName': 'Lee', 'Affiliation': 'Clinical Sciences & Study Management, MRL, Merck & Co, Inc.'}, {'ForeName': 'Ji', 'Initials': 'J', 'LastName': 'Liu', 'Affiliation': '126 E. Lincoln Ave., MRL, Merck & Co, Inc.'}, {'ForeName': 'Jingjun', 'Initials': 'J', 'LastName': 'Qiu', 'Affiliation': 'Merck Sharp & Dohme R&D.'}, {'ForeName': 'Shelonitda', 'Initials': 'S', 'LastName': 'Rose', 'Affiliation': 'Clinical Operations, Merck & Co., Inc.'}, {'ForeName': 'Eric H', 'Initials': 'EH', 'LastName': 'Rubin', 'Affiliation': 'VP Clinical Oncology, Merck Research Laboratories.'}, {'ForeName': 'Kathleen N', 'Initials': 'KN', 'LastName': 'Moore', 'Affiliation': 'Obstetrics and Gynecology, Stephenson Cancer Center, Stephenson Cancer Center at the University of Oklahoma Health Sciences Center/Sarah Cannon Research Institute.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-20-0219'] 2683,32611673,Effect of laser moxibustion for knee osteoarthritis: a multi-site double-blind randomized controlled trial.,"OBJECTIVE To examine the effects of laser moxibustion on pain and function in patients with knee osteoarthritis. METHODS A double-blind randomized clinical trial (4-week treatment, 20-week follow-up) was conducted. A total of 392 symptomatic knee osteoarthritis patients with moderate or greater clinically significant knee pain were randomly assigned to laser treatment or sham laser control group (1:1). Twelve sessions of laser moxibustion treatments or sham on the acupuncture points at the affected knee(s) were performed three times a week for 4 weeks. The primary outcome measurement was change in WOMAC pain score from baseline to week 4. RESULTS Among the 392 randomized participants, 364 (92.86%) completed the trial. The median WOMAC pain score significantly decreased at week 4 in the active group than in the sham group (2.1; 95% CI, 1.6 to 2.6; P < .01). At week 24, compared to the sham laser, active laser treatment resulted in significant pain reduction and function improvement (3.0; 95% CI, 2.5 to 3.6; P < 0.01, and 14.8; 95% CI, 11.9 to 17.6; P < .01, respectively). The physical component of the quality of life significantly improved in the active group than in the sham control at week 4 (3.2; 95% CI, 1.3 to 5.0; P = 0.001) up to week 24 (5.1; 95% CI, 3.3 to 7.0; P < .001). No serious adverse effects were reported. CONCLUSION Laser moxibustion resulted in statistically and clinically significant pain reduction and function improvement following a 4-week treatment in patients with knee osteoarthritis.",2020,Laser moxibustion resulted in statistically and clinically significant pain reduction and function improvement following a 4-week treatment in patients with knee osteoarthritis.,"['knee osteoarthritis', '392 randomized participants, 364 (92.86%) completed the trial', 'patients with knee osteoarthritis', '392 symptomatic knee osteoarthritis patients with moderate or greater clinically significant knee pain']","['laser treatment or sham laser control', 'Laser moxibustion', 'laser moxibustion']","['pain reduction and function improvement', 'pain and function', 'physical component of the quality of life', 'median WOMAC pain score', 'WOMAC pain score', 'serious adverse effects']","[{'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0231749', 'cui_str': 'Knee pain'}]","[{'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0026652', 'cui_str': 'Moxibustion'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",392.0,0.45296,Laser moxibustion resulted in statistically and clinically significant pain reduction and function improvement following a 4-week treatment in patients with knee osteoarthritis.,"[{'ForeName': 'Ling', 'Initials': 'L', 'LastName': 'Zhao', 'Affiliation': 'From the School of Acupuncture-Moxibustion and Tuina, Shanghai University of Traditional Chinese Medicine, Shanghai, China; School of Shanghai Research Center of Acupuncture & Meridian, China; Department of Orthopedics and Traumatology department Shuguang Hospital, Shanghai, China; Department of Traditional Chinese Medicine, Shanghai Tongren Traditional Chinese Medicine Hospital, Shanghai, China; Department of Biostatistics, Bioinformatics & Biomathematics Georgetown University Medical Center, Washington, USA; Virginia University of Integrative Medicine, Fairfax, USA. Address correspondence to Xueyong Shen, MD, School of Acupuncture-Moxibustion and Tuina, Shanghai University of Traditional Chinese Medicine, Shanghai, 201203, China , E-mail: sxy1@shutcm.edu.cn; Lixing Lao, PhD, Virginia University of Integrative Medicine, Fairfax, VA 22031, USA; School of Chinese Medicine, University of Hong Kong, Hong Kong, China ,E-mail: llao@vuim.edu.'}, {'ForeName': 'Ke', 'Initials': 'K', 'LastName': 'Cheng', 'Affiliation': 'From the School of Acupuncture-Moxibustion and Tuina, Shanghai University of Traditional Chinese Medicine, Shanghai, China; School of Shanghai Research Center of Acupuncture & Meridian, China; Department of Orthopedics and Traumatology department Shuguang Hospital, Shanghai, China; Department of Traditional Chinese Medicine, Shanghai Tongren Traditional Chinese Medicine Hospital, Shanghai, China; Department of Biostatistics, Bioinformatics & Biomathematics Georgetown University Medical Center, Washington, USA; Virginia University of Integrative Medicine, Fairfax, USA. Address correspondence to Xueyong Shen, MD, School of Acupuncture-Moxibustion and Tuina, Shanghai University of Traditional Chinese Medicine, Shanghai, 201203, China , E-mail: sxy1@shutcm.edu.cn; Lixing Lao, PhD, Virginia University of Integrative Medicine, Fairfax, VA 22031, USA; School of Chinese Medicine, University of Hong Kong, Hong Kong, China ,E-mail: llao@vuim.edu.'}, {'ForeName': 'Fan', 'Initials': 'F', 'LastName': 'Wu', 'Affiliation': 'From the School of Acupuncture-Moxibustion and Tuina, Shanghai University of Traditional Chinese Medicine, Shanghai, China; School of Shanghai Research Center of Acupuncture & Meridian, China; Department of Orthopedics and Traumatology department Shuguang Hospital, Shanghai, China; Department of Traditional Chinese Medicine, Shanghai Tongren Traditional Chinese Medicine Hospital, Shanghai, China; Department of Biostatistics, Bioinformatics & Biomathematics Georgetown University Medical Center, Washington, USA; Virginia University of Integrative Medicine, Fairfax, USA. Address correspondence to Xueyong Shen, MD, School of Acupuncture-Moxibustion and Tuina, Shanghai University of Traditional Chinese Medicine, Shanghai, 201203, China , E-mail: sxy1@shutcm.edu.cn; Lixing Lao, PhD, Virginia University of Integrative Medicine, Fairfax, VA 22031, USA; School of Chinese Medicine, University of Hong Kong, Hong Kong, China ,E-mail: llao@vuim.edu.'}, {'ForeName': 'Jiong', 'Initials': 'J', 'LastName': 'Du', 'Affiliation': 'From the School of Acupuncture-Moxibustion and Tuina, Shanghai University of Traditional Chinese Medicine, Shanghai, China; School of Shanghai Research Center of Acupuncture & Meridian, China; Department of Orthopedics and Traumatology department Shuguang Hospital, Shanghai, China; Department of Traditional Chinese Medicine, Shanghai Tongren Traditional Chinese Medicine Hospital, Shanghai, China; Department of Biostatistics, Bioinformatics & Biomathematics Georgetown University Medical Center, Washington, USA; Virginia University of Integrative Medicine, Fairfax, USA. Address correspondence to Xueyong Shen, MD, School of Acupuncture-Moxibustion and Tuina, Shanghai University of Traditional Chinese Medicine, Shanghai, 201203, China , E-mail: sxy1@shutcm.edu.cn; Lixing Lao, PhD, Virginia University of Integrative Medicine, Fairfax, VA 22031, USA; School of Chinese Medicine, University of Hong Kong, Hong Kong, China ,E-mail: llao@vuim.edu.'}, {'ForeName': 'Yue', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'From the School of Acupuncture-Moxibustion and Tuina, Shanghai University of Traditional Chinese Medicine, Shanghai, China; School of Shanghai Research Center of Acupuncture & Meridian, China; Department of Orthopedics and Traumatology department Shuguang Hospital, Shanghai, China; Department of Traditional Chinese Medicine, Shanghai Tongren Traditional Chinese Medicine Hospital, Shanghai, China; Department of Biostatistics, Bioinformatics & Biomathematics Georgetown University Medical Center, Washington, USA; Virginia University of Integrative Medicine, Fairfax, USA. Address correspondence to Xueyong Shen, MD, School of Acupuncture-Moxibustion and Tuina, Shanghai University of Traditional Chinese Medicine, Shanghai, 201203, China , E-mail: sxy1@shutcm.edu.cn; Lixing Lao, PhD, Virginia University of Integrative Medicine, Fairfax, VA 22031, USA; School of Chinese Medicine, University of Hong Kong, Hong Kong, China ,E-mail: llao@vuim.edu.'}, {'ForeName': 'Ming T', 'Initials': 'MT', 'LastName': 'Tan', 'Affiliation': 'From the School of Acupuncture-Moxibustion and Tuina, Shanghai University of Traditional Chinese Medicine, Shanghai, China; School of Shanghai Research Center of Acupuncture & Meridian, China; Department of Orthopedics and Traumatology department Shuguang Hospital, Shanghai, China; Department of Traditional Chinese Medicine, Shanghai Tongren Traditional Chinese Medicine Hospital, Shanghai, China; Department of Biostatistics, Bioinformatics & Biomathematics Georgetown University Medical Center, Washington, USA; Virginia University of Integrative Medicine, Fairfax, USA. Address correspondence to Xueyong Shen, MD, School of Acupuncture-Moxibustion and Tuina, Shanghai University of Traditional Chinese Medicine, Shanghai, 201203, China , E-mail: sxy1@shutcm.edu.cn; Lixing Lao, PhD, Virginia University of Integrative Medicine, Fairfax, VA 22031, USA; School of Chinese Medicine, University of Hong Kong, Hong Kong, China ,E-mail: llao@vuim.edu.'}, {'ForeName': 'Lixing', 'Initials': 'L', 'LastName': 'Lao', 'Affiliation': 'From the School of Acupuncture-Moxibustion and Tuina, Shanghai University of Traditional Chinese Medicine, Shanghai, China; School of Shanghai Research Center of Acupuncture & Meridian, China; Department of Orthopedics and Traumatology department Shuguang Hospital, Shanghai, China; Department of Traditional Chinese Medicine, Shanghai Tongren Traditional Chinese Medicine Hospital, Shanghai, China; Department of Biostatistics, Bioinformatics & Biomathematics Georgetown University Medical Center, Washington, USA; Virginia University of Integrative Medicine, Fairfax, USA. Address correspondence to Xueyong Shen, MD, School of Acupuncture-Moxibustion and Tuina, Shanghai University of Traditional Chinese Medicine, Shanghai, 201203, China , E-mail: sxy1@shutcm.edu.cn; Lixing Lao, PhD, Virginia University of Integrative Medicine, Fairfax, VA 22031, USA; School of Chinese Medicine, University of Hong Kong, Hong Kong, China ,E-mail: llao@vuim.edu.'}, {'ForeName': 'Xueyong', 'Initials': 'X', 'LastName': 'Shen', 'Affiliation': 'From the School of Acupuncture-Moxibustion and Tuina, Shanghai University of Traditional Chinese Medicine, Shanghai, China; School of Shanghai Research Center of Acupuncture & Meridian, China; Department of Orthopedics and Traumatology department Shuguang Hospital, Shanghai, China; Department of Traditional Chinese Medicine, Shanghai Tongren Traditional Chinese Medicine Hospital, Shanghai, China; Department of Biostatistics, Bioinformatics & Biomathematics Georgetown University Medical Center, Washington, USA; Virginia University of Integrative Medicine, Fairfax, USA. Address correspondence to Xueyong Shen, MD, School of Acupuncture-Moxibustion and Tuina, Shanghai University of Traditional Chinese Medicine, Shanghai, 201203, China , E-mail: sxy1@shutcm.edu.cn; Lixing Lao, PhD, Virginia University of Integrative Medicine, Fairfax, VA 22031, USA; School of Chinese Medicine, University of Hong Kong, Hong Kong, China ,E-mail: llao@vuim.edu.'}]",The Journal of rheumatology,['10.3899/jrheum.200217'] 2684,32611737,Protocol for a multinational risk-stratified randomised controlled trial in paediatric Crohn's disease: methotrexate versus azathioprine or adalimumab for maintaining remission in patients at low or high risk for aggressive disease course.,"INTRODUCTION Immunomodulators such as thiopurines (azathioprine (AZA)/6-mercaptopurine (6MP)), methotrexate (MTX) and biologics such as adalimumab (ADA) are well established for maintenance of remission within paediatric Crohn's disease (CD). It remains unclear, however, which maintenance medication should be used first line in specific patient groups. AIMS To compare the efficacy of maintenance therapies in newly diagnosed CD based on stratification into high and low-risk groups for severe CD evolution; MTX versus AZA/6MP in low-risk and MTX versus ADA in high-risk patients. Primary end point: sustained remission at 12 months (weighted paediatric CD activity index ≤12.5 and C reactive protein ≤1.5 fold upper limit) without relapse or ongoing requirement for exclusive enteral nutrition (EEN)/steroids 12 weeks after treatment initiation. METHODS AND ANALYSIS REDUCE-RISK in CD is an international multicentre open-label prospective randomised controlled trial funded by EU within the Horizon2020 framework (grant number 668023). Eligible patients (aged 6-17 years, new-onset disease receiving steroids or EEN for induction of remission for luminal ± perianal CD are stratified into low and high-risk groups based on phenotype and response to induction therapy. Participants are randomised to one of two treatment arms within their risk group: low-risk patients to weekly subcutaneous MTX or daily oral AZA/6MP, and high-risk patients to weekly subcutaneous MTX or fortnightly ADA. Patients are followed up for 12 months at prespecified intervals. Electronic case report forms are completed prospectively. The study aims to recruit 312 participants (176 low risk; 136 high risk). ETHICS AND DISSEMINATION ClinicalTrials.gov Identifier: (NCT02852694), authorisation and approval from local ethics committees have been obtained prior to recruitment. Individual informed consent will be obtained prior to participation in the study. Results will be published in a peer-reviewed journal with open access. TRIAL REGISTRATION NUMBER NCT02852694; Pre-results.",2020,"weighted paediatric CD activity index ≤12.5 and C reactive protein ≤1.5 fold upper limit) without relapse or ongoing requirement for exclusive enteral nutrition (EEN)/steroids 12 weeks after treatment initiation. ","['high-risk patients', ""paediatric Crohn's disease"", 'patients at low or high risk for aggressive disease course', '312 participants (176 low risk; 136 high risk', 'newly diagnosed CD based on stratification into high and low-risk groups for severe CD evolution', 'Eligible patients (aged 6-17 years, new-onset disease receiving steroids or EEN for induction of remission for luminal ± perianal\u2009CD']","['subcutaneous MTX or daily oral AZA/6MP, and high-risk patients to weekly subcutaneous MTX or fortnightly ADA', 'methotrexate versus azathioprine or adalimumab', 'thiopurines (azathioprine (AZA)/6-mercaptopurine (6MP)), methotrexate (MTX) and biologics such as adalimumab (ADA', 'MTX versus AZA/6MP', 'MTX versus ADA']",['sustained remission'],"[{'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0010346', 'cui_str': ""Crohn's disease""}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0001807', 'cui_str': 'Aggressive behavior'}, {'cui': 'C0242656', 'cui_str': 'Course of illness'}, {'cui': 'C4517706', 'cui_str': '312'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C4517568', 'cui_str': '136'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0015219', 'cui_str': 'Biological Evolution'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0038317', 'cui_str': 'Steroid'}, {'cui': 'C0014327', 'cui_str': 'Enteral nutrition'}, {'cui': 'C0035052', 'cui_str': 'Induction of Remission'}, {'cui': 'C0699493', 'cui_str': 'Luminal'}, {'cui': 'C0341395', 'cui_str': ""Perianal Crohn's disease""}]","[{'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0585332', 'cui_str': 'Biweekly'}, {'cui': 'C1122087', 'cui_str': 'adalimumab'}, {'cui': 'C0004482', 'cui_str': 'Azathioprine'}, {'cui': 'C0000618', 'cui_str': 'mercaptopurine'}, {'cui': 'C0005515', 'cui_str': 'Biological agent'}]","[{'cui': 'C0544452', 'cui_str': 'Remission phase'}]",,0.125767,"weighted paediatric CD activity index ≤12.5 and C reactive protein ≤1.5 fold upper limit) without relapse or ongoing requirement for exclusive enteral nutrition (EEN)/steroids 12 weeks after treatment initiation. ","[{'ForeName': 'Rachel E', 'Initials': 'RE', 'LastName': 'Harris', 'Affiliation': 'Department of Paediatric Gastroenterology, Royal Hospital for Children Glasgow, Glasgow, UK.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Aloi', 'Affiliation': 'Paediatric Gastroenterology and Liver Unit, Sapienza University of Rome, Roma, Lazio, Italy.'}, {'ForeName': 'Lissy', 'Initials': 'L', 'LastName': 'de Ridder', 'Affiliation': 'Paediatrics, Erasmus MC/Sophia Childrens Hospital, Rotterdam, The Netherlands l.deridder@erasmusmc.nl.'}, {'ForeName': 'Nicholas M', 'Initials': 'NM', 'LastName': 'Croft', 'Affiliation': 'Department of Paediatric Gastroenterology, Barts and The London School of Medicine and Dentistry, London, UK.'}, {'ForeName': 'Sibylle', 'Initials': 'S', 'LastName': 'Koletzko', 'Affiliation': ""Pediatric Gastroenterology and Hepatology, Dr. V. Hauner Children's Hospital, Munich, Germany.""}, {'ForeName': 'Arie', 'Initials': 'A', 'LastName': 'Levine', 'Affiliation': 'Edith Wolfson Medical Center, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Turner', 'Affiliation': 'Department of Paediatric Gastroenterology, Hebrew University of Jerusalem, Jerusalem, Israel.'}, {'ForeName': 'Gigi', 'Initials': 'G', 'LastName': 'Veereman', 'Affiliation': 'Pediatric GI, UZBrussels-VUB, Brussels, Belgium.'}, {'ForeName': 'Mattias', 'Initials': 'M', 'LastName': 'Neyt', 'Affiliation': 'ME-TA Medical Evaluation and Technology Assessment, Merendree, Belgium.'}, {'ForeName': 'Laetitia', 'Initials': 'L', 'LastName': 'Bigot', 'Affiliation': 'PIBD-Net, Hôpital universitaire Necker-Enfants malades, Paris, Île-de-France, France.'}, {'ForeName': 'Frank M', 'Initials': 'FM', 'LastName': 'Ruemmele', 'Affiliation': 'Service de Gastroentérologie Pédiatrique, Hôpital Universitaire Necker-Enfants Malades, Paris, Île-de-France, France.'}, {'ForeName': 'Richard K', 'Initials': 'RK', 'LastName': 'Russell', 'Affiliation': 'Department of Paediatric Gastroenterology, Royal Hospital for Children Glasgow, Glasgow, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",BMJ open,['10.1136/bmjopen-2019-034892'] 2685,32611863,"Comparison of antimicrobial efficacy of aqueous ozone, green tea, and normal saline as irrigants in pulpectomy procedures of primary teeth.","Aim Sodium hypochlorite, though considered an ideal root canal irrigant, cannot be used at required concentrations in children, due to its undesirable effects. Hence, it is imperative to search for an ideal root canal irrigant to avoid these undesirable effects which we hope to achieve with this study. The antimicrobial efficacy of aqueous ozone, green tea, and normal saline as irrigants in pulpectomy procedures of the primary teeth has been compared. Materials and Methods Sixty patients between 4 and 8 years of age with a single-rooted deciduous tooth indicated for pulpectomy were included. The infected teeth were randomly allocated to one of the three treatment groups based on the irrigating agents used, namely normal saline, green tea extract, or ozonated water. Specimens for anaerobic culture were collected three times from the teeth: before irrigation, after initial irrigation, and on the 3 rd day after final irrigation. Results and Conclusion Mean colony forming unit (CFU) count after both initial and final irrigation with ozonated water was significantly lower when compared with green tea and normal saline. Further, it was observed that the mean CFU count with green tea was significantly lower than the counts obtained with normal saline on the 3 rd day after final irrigation. Hence, both ozonated water and green tea could be considered a good alternative to conventional root canal irrigants in the primary teeth. Larger sample sizes with a larger variety of irrigants are recommended.",2020,"The antimicrobial efficacy of aqueous ozone, green tea, and normal saline as irrigants in pulpectomy procedures of the primary teeth has been compared. ","['Sixty patients between 4 and 8 years of age with a single-rooted deciduous tooth indicated for pulpectomy were included', 'pulpectomy procedures of primary teeth']","['irrigating agents used, namely normal saline, green tea extract, or ozonated water', 'aqueous ozone, green tea, and normal saline', 'green tea and normal saline']","['Mean colony forming unit (CFU) count', 'mean CFU count with green tea']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C3266841', 'cui_str': 'All deciduous teeth'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0034102', 'cui_str': 'Pulpectomy'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0449881', 'cui_str': 'Agent used'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C1704263', 'cui_str': 'Green Tea Extract'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0030106', 'cui_str': 'Ozone'}, {'cui': 'C1384640', 'cui_str': 'Green tea'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439158', 'cui_str': 'colonies'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C1384640', 'cui_str': 'Green tea'}]",60.0,0.035336,"The antimicrobial efficacy of aqueous ozone, green tea, and normal saline as irrigants in pulpectomy procedures of the primary teeth has been compared. ","[{'ForeName': 'Suchi', 'Initials': 'S', 'LastName': 'Agarwal', 'Affiliation': 'Department of Pedodontics and Preventive Dentistry, Bhabha College of Dental Sciences, Bhopal, India.'}, {'ForeName': 'Parimala', 'Initials': 'P', 'LastName': 'Tyagi', 'Affiliation': ""Department of Pedodontics and Preventive Dentistry, People's College of Dental Sciences and Research Centre, Bhopal, India.""}, {'ForeName': 'Ashwini', 'Initials': 'A', 'LastName': 'Deshpande', 'Affiliation': 'Department of Oral Medicine and Radiology, GSL Dental College and Hospital, Rajahmundry, Andhra Pradesh, India.'}, {'ForeName': 'Saurabh', 'Initials': 'S', 'LastName': 'Yadav', 'Affiliation': 'Department of Pedodontics and Preventive Dentistry, Children Dental College, Azamgarh, Uttar Pradesh, India.'}, {'ForeName': 'Vipul', 'Initials': 'V', 'LastName': 'Jain', 'Affiliation': 'Department of Orthodontics and Maxillofacial Orthopedics, Bhabha College of Dental Sciences, Bhopal, India.'}, {'ForeName': 'Kuldeep Singh', 'Initials': 'KS', 'LastName': 'Rana', 'Affiliation': 'Department of Conservative Dentistry and Endodontics, Government College of Dentistry, Indore, Madhya Pradesh, India.'}]",Journal of the Indian Society of Pedodontics and Preventive Dentistry,['10.4103/JISPPD.JISPPD_119_20'] 2686,31601180,Point-of-care ultrasound defines gastric content in elective surgical patients with type 2 diabetes mellitus: a prospective cohort study.,"BACKGROUND Delayed gastric emptying and the resultant ""full stomach"" is the most important risk factor for perioperative pulmonary aspiration. Using point-of-care gastric sonography, we aimed to investigate the prevalence of full stomach and its risk factors in elective surgical patients with type 2 diabetes. METHODS Type 2 diabetic and non-diabetic elective surgical patients were included from July 2017 to April 2018 in a 1:1 ratio. The study was retrospectively registered at July 2017, after enrollment of the first participant. Gastric ultrasound was performed 2 h after ingesting clear fluid or 6 h after a light meal. Full stomach was defined by the presence of gastric content in both semi-recumbent and right lateral decubitus positions. For patients with full or intermediate stomach, consecutive ultrasound scan was performed until empty stomach was detected. Logistic regression analyses were used to identify risk factors associated with full stomach. RESULTS Fifty-two type 2 diabetic and fifty non-diabetic patients were analyzed. The prevalence of full stomach was 48.1% (25/52) in diabetic patients, with 44.0% for 2-h fast after clear fluid and 51.9% for 6-h fast after a light meal, significantly higher than 8% (4/50) in non-diabetic patients (P = 0.000). The average time to empty stomach in diabetic patients was 146.50 ± 40.91 mins for clear liquid and 426.50 ± 45.25 mins for light meal, respectively. Further analysis indicated that presence of diabetes-related eye disease was an independent risk factor of full stomach in diabetic patients (OR = 4.83, P = 0.010). CONCLUSIONS Almost half of type 2 diabetic patients have a full stomach following the current preoperative fasting guideline. Preoperative ultrasound assessment of gastric content in type 2 diabetic patients is suggested, especially for those with diabetes -related eye disease. TRIAL REGISTRATION The trial was registered at www.clinicaltrials.gov with registration number NCT03217630 . Retrospectively registered on 14th July 2017.",2019,"The prevalence of full stomach was 48.1% (25/52) in diabetic patients, with 44.0% for 2-h fast after clear fluid and 51.9% for 6-h fast after a light meal, significantly higher than 8% (4/50) in non-diabetic patients (P = 0.000).","['elective surgical patients with type 2 diabetes mellitus', 'Fifty-two type 2 diabetic and fifty non-diabetic patients', 'Type 2 diabetic and non-diabetic elective surgical patients were included from July 2017 to April 2018 in a 1:1 ratio', 'elective surgical patients with type 2 diabetes', 'type 2 diabetic patients']",[],"['prevalence of full stomach', 'average time to empty stomach']","[{'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C4319570', 'cui_str': '52'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",[],"[{'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0038351', 'cui_str': 'Stomach'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",,0.0243042,"The prevalence of full stomach was 48.1% (25/52) in diabetic patients, with 44.0% for 2-h fast after clear fluid and 51.9% for 6-h fast after a light meal, significantly higher than 8% (4/50) in non-diabetic patients (P = 0.000).","[{'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Zhou', 'Affiliation': 'Department of Anesthesiology and Translational Neuroscience Center, West China Hospital, Sichuan University, Chengdu, 610041, Sichuan, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Department of Anesthesiology, Cheng Du Shang Jin Nan Fu Hospital, Chengdu, 610000, Sichuan, China.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': 'Department of Anesthesiology and Translational Neuroscience Center, West China Hospital, Sichuan University, Chengdu, 610041, Sichuan, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Cao', 'Affiliation': 'Department of Anesthesiology, Cheng Du Shang Jin Nan Fu Hospital, Chengdu, 610000, Sichuan, China.'}, {'ForeName': 'Heng', 'Initials': 'H', 'LastName': 'Jing', 'Affiliation': 'Department of Anesthesiology, Cheng Du Shang Jin Nan Fu Hospital, Chengdu, 610000, Sichuan, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Xu', 'Affiliation': 'Department of Anesthesiology and Translational Neuroscience Center, West China Hospital, Sichuan University, Chengdu, 610041, Sichuan, China.'}, {'ForeName': 'Xiaojuan', 'Initials': 'X', 'LastName': 'Jiang', 'Affiliation': 'Department of Anesthesiology and Translational Neuroscience Center, West China Hospital, Sichuan University, Chengdu, 610041, Sichuan, China.'}, {'ForeName': 'Danfeng', 'Initials': 'D', 'LastName': 'Xu', 'Affiliation': 'Department of Anesthesiology and Translational Neuroscience Center, West China Hospital, Sichuan University, Chengdu, 610041, Sichuan, China.'}, {'ForeName': 'Qianhui', 'Initials': 'Q', 'LastName': 'Xiao', 'Affiliation': 'Department of Anesthesiology and Translational Neuroscience Center, West China Hospital, Sichuan University, Chengdu, 610041, Sichuan, China.'}, {'ForeName': 'Chunling', 'Initials': 'C', 'LastName': 'Jiang', 'Affiliation': 'Department of Anesthesiology and Translational Neuroscience Center, West China Hospital, Sichuan University, Chengdu, 610041, Sichuan, China. jiangchunling@scu.edu.cn.'}, {'ForeName': 'Lulong', 'Initials': 'L', 'LastName': 'Bo', 'Affiliation': 'Faculty of Anaesthesiology, Changhai Hospital, Naval Medical University, Shanghai, 200433, China. bartbo@smmu.edu.cn.'}]",BMC anesthesiology,['10.1186/s12871-019-0848-x'] 2687,31628085,"Efficacy, safety, and biomarker analysis of ensartinib in crizotinib-resistant, ALK-positive non-small-cell lung cancer: a multicentre, phase 2 trial.","BACKGROUND Ensartinib is a potent new-generation ALK inhibitor with high activity against a broad range of known crizotinib-resistant ALK mutations and CNS metastases. We aimed to assess the efficacy and safety of ensartinib in ALK-positive patients with non-small-cell lung cancer (NSCLC), in whom crizotinib therapy was unsuccessful. The associations between ensartinib efficacy and crizotinib-resistant mutations were also explored. METHODS We did a single-arm, open-label, phase 2 study at 27 centres in China. Patients were aged 18 years or older, had stage IIIb or stage IV ALK-positive NSCLC that had progressed while they were on crizotinib therapy, an Eastern Cooperative Oncology Group performance status of 2 or less, had measurable disease, and had received fewer than three previous treatments. Patients with CNS metastases were included if these metastases were asymptomatic and did not require steroid therapy. All patients received 225 mg ensartinib orally once daily on a continuous dosing schedule. The primary outcome was the proportion of patients with an objective response according to the Response Evaluation Criteria in Solid Tumors (version 1.1), as assessed by an independent review committee in all patients who received at least one dose of ensartinib with no major violations of the inclusion criteria (ie, the full analysis set). Safety was assessed in all enrolled patients who received at least one dose of ensartinib. This trial was registered with ClinicalTrials.gov, NCT03215693. FINDINGS Between Sept 28, 2017, and April 11, 2018, 160 patients were enrolled and had at least one dose of ensartinib (safety analysis set). Four patients had inclusion violations and were excluded from the efficacy analysis, which thus included 156 patients (full analysis set). 97 (62%) patients in the full analysis set had brain metastases. 76 (52% [95% CI 43-60]) of 147 patients in the full analysis set, with responses that could be assessed by the independent review committee, had an objective response. 28 (70% [53-83]) of 40 patients with measurable brain metastases as assessed by the independent review committee had an intracranial objective response. 145 (91%) of 160 patients had at least one treatment-related adverse event, which were mostly grade 1 or 2. The most common treatment-related adverse events were rash (89 [56%]), increased alanine aminotransferase concentrations (74 [46%]), and increased aspartate aminotransferase concentrations (65 [41%]). INTERPRETATION Ensartinib has activity and is well tolerated in patients with crizotinib-refractory, ALK-positive NSCLC, including those with brain metastases. The role of ensartinib in patients in whom other second-generation ALK inhibitors have been unsuccessful warrants further studies. FUNDING Betta Pharmaceuticals.",2020,"The most common treatment-related adverse events were rash (89 [56%]), increased alanine aminotransferase concentrations (74 [46%]), and increased aspartate aminotransferase concentrations (65 [41%]). ","['Patients were aged 18 years or older, had stage IIIb or stage IV ALK-positive NSCLC that had progressed while they were on crizotinib therapy, an Eastern Cooperative Oncology Group performance status of 2 or less, had measurable disease, and had received fewer than three previous treatments', 'ALK-positive patients with non-small-cell lung cancer (NSCLC', '76', 'Patients with CNS metastases', '40 patients with measurable brain metastases', 'Between Sept 28, 2017, and April 11, 2018, 160 patients were enrolled and had at least one dose of ensartinib (safety analysis set', 'patients with crizotinib-refractory, ALK-positive NSCLC, including those with brain metastases', 'enrolled patients who received at least one dose of ensartinib', 'patients in whom other second-generation ALK inhibitors have been unsuccessful warrants further studies', 'Four patients had inclusion violations and were excluded from the efficacy analysis, which thus included 156 patients (full analysis set']",[],"['alanine aminotransferase concentrations', 'Safety', 'proportion of patients with an objective response', 'efficacy and safety', 'Efficacy, safety, and biomarker analysis of ensartinib in crizotinib-resistant, ALK-positive non-small-cell lung cancer', 'brain metastases', 'aspartate aminotransferase concentrations', 'intracranial objective response']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0456599', 'cui_str': 'Stage 3B'}, {'cui': 'C0441772', 'cui_str': 'Stage level 4'}, {'cui': 'C1663627', 'cui_str': 'ALK protein, human'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1520224', 'cui_str': 'ECOG performance status'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0205388', 'cui_str': 'Few'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0279130', 'cui_str': 'CNS metastases'}, {'cui': 'C0220650', 'cui_str': 'Secondary malignant neoplasm of brain'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C4524311', 'cui_str': 'ensartinib'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C2974289', 'cui_str': 'crizotinib'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C1272705', 'cui_str': 'Unsuccessful'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",[],"[{'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C4524311', 'cui_str': 'ensartinib'}, {'cui': 'C2974289', 'cui_str': 'crizotinib'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C1663627', 'cui_str': 'ALK protein, human'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0220650', 'cui_str': 'Secondary malignant neoplasm of brain'}, {'cui': 'C0004002', 'cui_str': 'Aspartate aminotransferase'}, {'cui': 'C0524466', 'cui_str': 'Intracranial'}]",160.0,0.645766,"The most common treatment-related adverse events were rash (89 [56%]), increased alanine aminotransferase concentrations (74 [46%]), and increased aspartate aminotransferase concentrations (65 [41%]). ","[{'ForeName': 'Yunpeng', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Department of Medical Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China.'}, {'ForeName': 'Jianya', 'Initials': 'J', 'LastName': 'Zhou', 'Affiliation': 'Department of Respiratory Disease, Thoracic Disease Center, The First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, China.'}, {'ForeName': 'Jianying', 'Initials': 'J', 'LastName': 'Zhou', 'Affiliation': 'Department of Respiratory Disease, Thoracic Disease Center, The First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, China.'}, {'ForeName': 'Jifeng', 'Initials': 'J', 'LastName': 'Feng', 'Affiliation': 'Department of Medical Oncology, Jiangsu Cancer Hospital, Jiangsu Institute of Cancer Research, The Affiliated Cancer Hospital of Nanjing Medical University, Nanjing, China.'}, {'ForeName': 'Wu', 'Initials': 'W', 'LastName': 'Zhuang', 'Affiliation': 'Department of Thoracic Oncology, Fujian Provincial Cancer Hospital, Fujian Medical University Cancer Hospital, Fuzhou, China.'}, {'ForeName': 'Jianhua', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Department of Medical Oncology-Chest, Hunan Cancer Hospital, Changsha, China.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Zhao', 'Affiliation': 'Department of Thoracic Oncology, Beijing Cancer Hospital, Beijing, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Zhong', 'Affiliation': 'Department of Pulmonary Medicine, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Yanqiu', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'Respiratory Department of Internal Medicine, Henan Provincial Cancer Hospital, Affiliated Cancer Hospital of Zhengzhou University, Zhengzhou, China.'}, {'ForeName': 'Yiping', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Thoracic Medical Oncology, Zhejiang Cancer Hospital, Hangzhou, China.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Song', 'Affiliation': 'Division of Respiratory Medicine, Jinling Hospital, Nanjing University School of Medicine, Nanjing, China.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': 'Department of Oncology, Chinese PLA General Hospital, Beijing, China.'}, {'ForeName': 'Zhuang', 'Initials': 'Z', 'LastName': 'Yu', 'Affiliation': 'Department of Oncology, The Affiliated Hospital of Qingdao University, Qingdao, China.'}, {'ForeName': 'Youling', 'Initials': 'Y', 'LastName': 'Gong', 'Affiliation': 'Department of Thoracic Oncology, Cancer Center, West China Hospital, Sichuan University, Chengdu, China.'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Chen', 'Affiliation': 'Department of Oncology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Ye', 'Affiliation': 'Department of Medical Oncology, Cancer Hospital, The First Affiliated Hospital of Xiamen University, School of Medicine, Xiamen University, Teaching Hospital of Fujian Medical University, Xiamen, China.'}, {'ForeName': 'Shucai', 'Initials': 'S', 'LastName': 'Zhang', 'Affiliation': 'Department of Medical Oncology, Beijing Chest Hospital, Capital Medical University, Beijing Tuberculosis and Thoracic Tumor Research Institute, Beijing, China.'}, {'ForeName': 'Lejie', 'Initials': 'L', 'LastName': 'Cao', 'Affiliation': 'Respiratory Medicine, The First Affiliated Hospital of the University of Science and Technology of China, Anhui Provincial Hospital, Hefei, China.'}, {'ForeName': 'Yun', 'Initials': 'Y', 'LastName': 'Fan', 'Affiliation': 'Thoracic Medical Oncology, Zhejiang Cancer Hospital, Hangzhou, China.'}, {'ForeName': 'Gang', 'Initials': 'G', 'LastName': 'Wu', 'Affiliation': 'Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.'}, {'ForeName': 'Yubiao', 'Initials': 'Y', 'LastName': 'Guo', 'Affiliation': 'Pulmonary & Critical Care Medicine, The First Affiliated Hospital, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Chengzhi', 'Initials': 'C', 'LastName': 'Zhou', 'Affiliation': 'Respiratory Medicine Department, State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.'}, {'ForeName': 'Kewei', 'Initials': 'K', 'LastName': 'Ma', 'Affiliation': 'Cancer Center, The First Hospital of Jilin University, Changchun, China.'}, {'ForeName': 'Jian', 'Initials': 'J', 'LastName': 'Fang', 'Affiliation': 'Department of Thoracic Oncology, Beijing Cancer Hospital, Beijing, China.'}, {'ForeName': 'Weineng', 'Initials': 'W', 'LastName': 'Feng', 'Affiliation': ""Department of Head and Neck and Thoracic Medical Oncology, The First People's Hospital Of Foshan, Foshan, China.""}, {'ForeName': 'Yunpeng', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Oncology Medicine, The First Hospital of China Medical University, Shenyang, China.'}, {'ForeName': 'Zhendong', 'Initials': 'Z', 'LastName': 'Zheng', 'Affiliation': 'Oncology Department, General Hospital of Northern Theater Command, Shenyang, China.'}, {'ForeName': 'Gaofeng', 'Initials': 'G', 'LastName': 'Li', 'Affiliation': '2nd Department of Thoracic Surgery, Yunnan Cancer Hospital, Kunming, China.'}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Wu', 'Affiliation': 'Department of Diagnostic Radiology, National Cancer Center, National Clinical Research Center for Cancer, Cancer Hospital, Chinese Academy of Medical Sciences, Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Song', 'Affiliation': 'Department of Radiology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Xiaoqing', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'Department of Pulmonary Oncology, The Fifth Medical Centre Chinese PLA General Hospital, Beijing, China.'}, {'ForeName': 'Shijun', 'Initials': 'S', 'LastName': 'Zhao', 'Affiliation': 'Department of Diagnostic Radiology, National Cancer Center, National Clinical Research Center for Cancer, Cancer Hospital, Chinese Academy of Medical Sciences, Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Lieming', 'Initials': 'L', 'LastName': 'Ding', 'Affiliation': 'Betta Pharmaceuticals, Hangzhou, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Mao', 'Affiliation': 'Betta Pharmaceuticals, Hangzhou, China.'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Selvaggi', 'Affiliation': 'X-covery Holdings, Palm Beach Gardens, FL, USA.'}, {'ForeName': 'Xiaobin', 'Initials': 'X', 'LastName': 'Yuan', 'Affiliation': 'Betta Pharmaceuticals, Hangzhou, China.'}, {'ForeName': 'Yuanqing', 'Initials': 'Y', 'LastName': 'Fu', 'Affiliation': 'Betta Pharmaceuticals, Hangzhou, China.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Wang', 'Affiliation': 'Hangzhou Repugene Technology, Hangzhou, China.'}, {'ForeName': 'Shanshan', 'Initials': 'S', 'LastName': 'Xiao', 'Affiliation': 'Hangzhou Repugene Technology, Hangzhou, China.'}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Department of Medical Oncology, Sun Yat-sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou, China. Electronic address: zhangli@sysucc.org.cn.'}]",The Lancet. Respiratory medicine,['10.1016/S2213-2600(19)30252-8'] 2688,31664347,Influence of adapted hip-hop dancing on quality of life and social participation among children/adolescents with cerebral palsy.,"OBJECTIVE To describe the influence of adapted hip-hop dancing on the quality of life (QoL) and biopsychosocial profile of children/adolescents with cerebral palsy (CP). METHODS Pilot study including 18 children/adolescents with CP and Gross Motor Function Classification System levels I and II. Nine participants took part in an adapted hip-hop dance practice (study group; SG), and nine others served as the control group (CG). All participants were assessed with the Pediatric Outcomes Data Collection Instrument and the Child Behavior Checklist at baseline and after at least three months of dance practice and a public performance (SG) or a similar period without intervention (CG). RESULTS Improvement in QoL was observed in the SG in the domains of transfer and basic mobility (p = 0.00*), sporting and physical function (p = 0.04*), and global function and symptoms (p = 0.01*). In the SG, there was a reduction in emotional and behavioral problems and an increase in social competence in the biopsychosocial profile. Greater participation in adapted hip-hop dancing was associated with a greater gain in the transfer and basic mobility domains (p = 0.05*) of the Pediatric Outcomes Data Collection Instrument and in the activities (p = 0.05*) and social (p = 0.04*) scales of the Child Behavior Checklist. CONCLUSIONS Children/adolescents with CP participating in adapted hip-hop dance practice showed improvement in QoL and biopsychosocial profile scores.",2019,"RESULTS Improvement in QoL was observed in the SG in the domains of transfer and basic mobility (p = 0.00","['children/adolescents with cerebral palsy', 'Children/adolescents with CP participating', 'children/adolescents with cerebral palsy (CP', '18 children/adolescents with CP and Gross Motor Function Classification System levels I and II', 'Nine participants took part in an adapted hip-hop dance practice (study group; SG), and nine others served as the control group (CG']","['adapted hip-hop dancing', 'public performance (SG) or a similar period without intervention (CG']","['QoL and biopsychosocial profile scores', 'QoL', 'transfer and basic mobility', 'quality of life and social participation', 'Child Behavior Checklist', 'sporting and physical function', 'social competence', 'quality of life (QoL) and biopsychosocial profile', 'global function and symptoms', 'emotional and behavioral problems']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0007789', 'cui_str': 'Cerebral palsy'}, {'cui': 'C0677549', 'cui_str': 'Gross motor functions'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0441925', 'cui_str': 'Level I'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C4046022', 'cui_str': 'Hip-Hop Dance'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0078040', 'cui_str': 'VAP protocol'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0814554', 'cui_str': 'Social Participation'}, {'cui': 'C0008065', 'cui_str': 'Behavior, Child'}, {'cui': 'C1707357', 'cui_str': 'Checklist'}, {'cui': 'C0038039', 'cui_str': 'Sport'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0679005', 'cui_str': 'Social Abilities'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0233514', 'cui_str': 'Abnormal behavior'}]",18.0,0.017978,"RESULTS Improvement in QoL was observed in the SG in the domains of transfer and basic mobility (p = 0.00","[{'ForeName': 'Joseana Wendling', 'Initials': 'JW', 'LastName': 'Withers', 'Affiliation': 'Universidade Federal do Paraná, Setor de Ciências da Saúde, Pós-graduação em Saúde da Criança e do Adolescente, Curitiba PR, Brasil.'}, {'ForeName': 'Sandra Baggio', 'Initials': 'SB', 'LastName': 'Muzzolon', 'Affiliation': 'Universidade Federal do Paraná, Hospital de Clínicas, Serviço de Psicologia, Curitiba PR, Brasil.'}, {'ForeName': 'Marise Bueno', 'Initials': 'MB', 'LastName': 'Zonta', 'Affiliation': 'Universidade Federal do Paraná, Hospital de Clínicas, Serviço de Reabilitação, Curitiba PR, Brasil.'}]",Arquivos de neuro-psiquiatria,['10.1590/0004-282X20190124'] 2689,32614875,Participation in interventions and recommended follow-up for non-attendees in cervical cancer screening -taking the women's own preferred test method into account-A Swedish randomised controlled trial.,"BACKGROUND Cervical cancer is a highly preventable disease. To not attend an organized cervical cancer screening program increases the risk for cervical dysplasia and cervical cancer. The aim was to investigate the participation rate in three different intervention groups for non- attendees in the Swedish national program for cervical screening. The participation in the recommended follow up, and the histology found were also examined. METHOD Population-based randomized control trial. It included10,614 women that had not participated in the cervical cancer screening programme during the last six years (ages 30-49) and the last eight years (ages 50-64) were randomised 1:1:1(telephone call from a midwife (offering the choice between a visit for a pap smear or an HPV self-sampling test); an HPV self-sampling test only; or the routine procedure with a yearly invitation). RESULTS In the intention to treat analysis the participation rates were 25.5% (N = 803/3146) vs 34.1% (N = 1047/3068) and 7.0% (N = 250/3538) (p<0.001) for telephone, HPV self-test and control groups respectively. In the by protocol analysis including women that answered the phone call the participation rates were 31.7% (N = 565/1784) vs 26.1% (N = 788/3002) and 7.0% (N = 250/3538) (p<0.001) for telephone, HPV self-test and control groups. The corresponding results in the by protocol analysis including women that did not answer the phone call was 19.7% (N = 565/2870) vs 26.1% (N = 788/3002) and 7.0% (N = 250/3538) (p< 0.001). The majority of the women 63,4% (1131/1784) who answered the telephone wanted to participate either by booking a visit for pap smear (38,5%) or to be sent a HPV self- sampling test (24,9%) (p<0.001). Women who chose an HPV self-test were older and gave anxiety/ fear as a reason to decline participation, and they were also less likely to participate in the follow-up if found to be HPV-positive compared to the women who chose a Pap smear. The attendance to the recommended follow-up after abnormality was in total 87%. The non-attendees had a three or eight times higher risk of having a cytology result of HSIL or suspected SCC respectively, in the index sample compared to women screened as recommended (OR 3.3 CI 95% 1.9-5.2, OR 8.6 CI 1.6-30). A total of ten SCC and one adenocarcinoma were found in the histopathology results from the non-attendee group with a study intervention, while there was only one SCC in the non-attendee group without any study intervention (p = 0.02, OR 8.1 CI 95% 1.2-350). CONCLUSIONS Our study suggests, according to intention to treat analysis, that the best intervention to get as many non-attendees as possible to participate is to send an HPV self-sampling test together with an invitation letter. Almost 90% of women in the study with an abnormal index sample attended follow-up. This is high enough to indicate that interventions to increase the participation among non-attendees are meaningful. REGISTRY International Standard Randomised Controlled Trial Number (ISRCTN) Registration number ISRCTN78719765.",2020,In the intention to treat analysis the participation rates were 25.5% (N = 803/3146) vs 34.1% (N = 1047/3068) and 7.0% (N = 250/3538) (,"['It included10,614 women that had not participated in the cervical cancer screening programme during the last six years (ages 30-49) and the last eight years (ages 50-64', 'non- attendees in the Swedish national program for cervical screening']","['1:1:1(telephone call from a midwife (offering the choice between a visit for a pap smear or an HPV self-sampling test); an HPV self-sampling test only; or the routine procedure with a yearly invitation', 'organized cervical cancer screening program']","['participation rates', 'participation rate', 'cervical dysplasia and cervical cancer']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0347984', 'cui_str': 'During'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0038996', 'cui_str': 'Swedish language'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}]","[{'cui': 'C0026083', 'cui_str': 'Professional midwife'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C1704447', 'cui_str': 'Patient visit for'}, {'cui': 'C0079104', 'cui_str': 'Smear cervix'}, {'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1298805', 'cui_str': 'Routine procedure'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C1300196', 'cui_str': 'Organized'}, {'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0007868', 'cui_str': 'Dysplasia of cervix'}, {'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix'}]",10.0,0.0285619,In the intention to treat analysis the participation rates were 25.5% (N = 803/3146) vs 34.1% (N = 1047/3068) and 7.0% (N = 250/3538) (,"[{'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Lilliecreutz', 'Affiliation': ""Department of Obstetrics and Gynaecology and Division of Children's and Women's Health, Department of Biomedical and Clinical Sciences, Faculty of Medicine and Health Sciences, Linköping University, Linköping, Sweden.""}, {'ForeName': 'Hanna', 'Initials': 'H', 'LastName': 'Karlsson', 'Affiliation': ""Department of Obstetrics and Gynaecology and Division of Children's and Women's Health, Department of Biomedical and Clinical Sciences, Faculty of Medicine and Health Sciences, Linköping University, Linköping, Sweden.""}, {'ForeName': 'Anna-Clara', 'Initials': 'AC', 'LastName': 'Spetz Holm', 'Affiliation': ""Department of Obstetrics and Gynaecology and Division of Children's and Women's Health, Department of Biomedical and Clinical Sciences, Faculty of Medicine and Health Sciences, Linköping University, Linköping, Sweden.""}]",PloS one,['10.1371/journal.pone.0235202'] 2690,32614987,Intradermal Injection of IncobotulinumtoxinA for Face Lifting.,"BACKGROUND Intradermal injection of botulinumtoxinA (BoNT/A) has been used off-label by many clinicians for the purpose of face-lifting effect. Some studies on AbobotulinumtoxinA (AboA) demonstrated clinical efficacy on face-lifting effect when comparing to normal saline solution (NSS). So far, there is no split-face comparison study on face-lifting effect of IncobotulinumtoxinA (IncoA). OBJECTIVE The objective of this study was to compare the face-lifting effect of IncoA intradermal injection and NSS. METHODS Twenty-two subjects were enrolled and randomly injected with IncoA at 1:6 cc dilution (100 unit or 1 vial in 6 cc of NSS) on one side, and NSS on the other side by using intradermal injection technique. Standardized photographic documentation with 2-, and 3-dimentional imaging system (Vectra H1, Canfield Scientific, Inc, Fairfield, NJ) were obtained at baseline, and at 2 weeks after treatment. The face-lifting effect were graded by the subjects and 2 blinded dermatologists, using photographic comparison. Side effects were also recorded at the end of the study. RESULTS Immediate face-lifting was identified on the side that was treated with IncoA by blinded injectors in 63.6% of patients. Of all subjects, 17 (77.3%) have noticed the improvement of skin laxity on the side that was treated with IncoA at 2 weeks after treatment. The difference in facial contouring volume measured by Vectra H1 imaging system on IncoA side was significantly higher (p=0.033) when comparing to NSS side in patients aged less than 36 years old. However, there was no statistically significant difference in face-lifting when comparing between IncoA and NSS evaluated by 2 blinded dermatologists (p=1.00). Facial asymmetry was found in 36.4% of subjects. CONCLUSIONS This study demonstrated the face-lifting effect of IncoA intradermal injection. Further studies with larger number of subjects and proper method of evaluation should be done to verify these findings. This article is protected by copyright. All rights reserved.",2020,"Of all subjects, 17 (77.3%) have noticed the improvement of skin laxity on the side that was treated with IncoA at 2 weeks after treatment.",['Twenty-two subjects were enrolled and randomly injected with'],"['IncobotulinumtoxinA', 'IncoA at 1:6 cc dilution (100 unit or 1 vial in 6 cc of NSS', 'botulinumtoxinA', 'IncoA intradermal injection and NSS', 'AbobotulinumtoxinA (AboA']","['Side effects', 'Facial asymmetry', 'skin laxity', 'facial contouring volume']","[{'cui': 'C4284772', 'cui_str': '22'}, {'cui': 'C1720154', 'cui_str': 'Inject'}]","[{'cui': 'C2930113', 'cui_str': 'IncobotulinumtoxinA'}, {'cui': 'C0079240', 'cui_str': 'Dilution'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C1706398', 'cui_str': 'Vial - unit of product usage'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0021489', 'cui_str': 'Intradermal injection'}, {'cui': 'C2719424', 'cui_str': 'AbobotulinumtoxinA'}]","[{'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0546952', 'cui_str': 'Congenital facial asymmetry'}, {'cui': 'C0010495', 'cui_str': 'Cutis laxa'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0449468', 'cui_str': 'Volume'}]",22.0,0.0195465,"Of all subjects, 17 (77.3%) have noticed the improvement of skin laxity on the side that was treated with IncoA at 2 weeks after treatment.","[{'ForeName': 'Rungsima', 'Initials': 'R', 'LastName': 'Wanitphakdeedecha', 'Affiliation': 'Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, THAILAND.'}, {'ForeName': 'Ya-Nin', 'Initials': 'YN', 'LastName': 'Nokdhes', 'Affiliation': 'Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, THAILAND.'}, {'ForeName': 'Poramin', 'Initials': 'P', 'LastName': 'Patthamalai', 'Affiliation': 'Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, THAILAND.'}, {'ForeName': 'Chadakan', 'Initials': 'C', 'LastName': 'Yan', 'Affiliation': 'Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, THAILAND.'}, {'ForeName': 'Thanya', 'Initials': 'T', 'LastName': 'Techapichetvanich', 'Affiliation': 'Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, THAILAND.'}, {'ForeName': 'Weeranut', 'Initials': 'W', 'LastName': 'Phothong', 'Affiliation': 'Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, THAILAND.'}, {'ForeName': 'Sasima', 'Initials': 'S', 'LastName': 'Eimpunth', 'Affiliation': 'Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, THAILAND.'}, {'ForeName': 'Woraphong', 'Initials': 'W', 'LastName': 'Manuskiatti', 'Affiliation': 'Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, THAILAND.'}]",Dermatologic therapy,['10.1111/dth.13944'] 2691,32615017,"A Prospective, Multi-Center, Clinical Trial of 10 kHz Spinal Cord Stimulation System in the Treatment of Chronic Pelvic Pain.","BACKGROUND Chronic pelvic pain (CPP) is a debilitating condition that often leads to disability and does not respond to conventional treatments. This study was conducted to evaluate the effects of paresthesia independent 10 kHz spinal cord stimulation (10 kHz SCS) in subjects with CPP. METHODS This prospective, single-arm pilot study enrolled subjects with clinical diagnoses of CPP and mean pain scores of ≥5.0 cm on a 10-cm visual analog scale (VAS). Subjects underwent trial stimulations with 10 kHz SCS, and those who had successful trial stimulations (≥40% pain relief) received permanently implanted devices and were followed for 12 months. RESULTS Of the 21 subjects who underwent 10 kHz SCS trial, 17 were successful and 14 subjects received permanent implants. No neurological deficits were observed in any subjects and all AEs were resolved without sequelae during the study period. Over 12 months, mean VAS scores decreased by 72% from baseline, and 10 of 13 subjects (77%) were responders (≥50% pain relief). Pain remission (VAS ≤3.0 cm) was reported by 8 of 13 subjects (62%), and mean pain scores on the McGill Pain Questionnaire (SF-MPQ-2) decreased as well. The Pain Disability Index (PDI) declined by 29 points, and 85% of the subjects reported satisfaction. CONCLUSIONS Paresthesia-independent stimulation with 10 kHz SCS reduced pelvic pain in subjects with CPP and was not associated with any unexpected AEs. While larger, controlled studies are needed, results of this study suggest that this therapeutic modality could potentially treat CPP patients while improving their quality of life.",2020,"CONCLUSIONS Paresthesia-independent stimulation with 10 kHz SCS reduced pelvic pain in subjects with CPP and was not associated with any unexpected AEs.","['subjects with CPP', '21 subjects who underwent 10 kHz SCS trial, 17 were successful and 14 subjects received permanent implants', 'Chronic Pelvic Pain', 'Chronic pelvic pain (CPP', 'enrolled subjects with clinical diagnoses of CPP and mean pain scores of ≥5.0 cm on a 10-cm visual analog scale (VAS']","['paresthesia independent 10 kHz spinal cord stimulation (10 kHz SCS', '10 kHz SCS', '10 kHz Spinal Cord Stimulation System']","['quality of life', 'mean VAS scores', 'Pain Disability Index (PDI', 'pelvic pain', 'mean pain scores', 'Pain remission', 'neurological deficits', 'McGill Pain Questionnaire (SF-MPQ-2']","[{'cui': 'C0404484', 'cui_str': 'Chronic pelvic pain of female'}, {'cui': 'C0556965', 'cui_str': 'kHz'}, {'cui': 'C0175699', 'cui_str': 'Saethre-Chotzen syndrome'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0205355', 'cui_str': 'Permanent'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0332140', 'cui_str': 'Clinical diagnosis'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0052080', 'cui_str': 'antineoplaston A10'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]","[{'cui': 'C0030554', 'cui_str': 'Paresthesia'}, {'cui': 'C1299583', 'cui_str': 'Independent'}, {'cui': 'C0556965', 'cui_str': 'kHz'}, {'cui': 'C0394477', 'cui_str': 'Neurostimulation of spinal cord tissue'}, {'cui': 'C0175699', 'cui_str': 'Saethre-Chotzen syndrome'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0030794', 'cui_str': 'Pain in pelvis'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C0521654', 'cui_str': 'Motor dysfunction'}, {'cui': 'C0024985', 'cui_str': 'McGill pain chart questionnaire'}]",17.0,0.0906093,"CONCLUSIONS Paresthesia-independent stimulation with 10 kHz SCS reduced pelvic pain in subjects with CPP and was not associated with any unexpected AEs.","[{'ForeName': 'Jordan L', 'Initials': 'JL', 'LastName': 'Tate', 'Affiliation': 'Alliance Spine and Pain Centers, Canton, GA, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Stauss', 'Affiliation': 'Advanced Pain Management, Milwaukee, WI, USA.'}, {'ForeName': 'Sean', 'Initials': 'S', 'LastName': 'Li', 'Affiliation': 'Premier Pain Centers, Shrewsbury, NJ, USA.'}, {'ForeName': 'Anand', 'Initials': 'A', 'LastName': 'Rotte', 'Affiliation': 'Nevro Corp, Redwood City, CA, USA.'}, {'ForeName': 'Jeyakumar', 'Initials': 'J', 'LastName': 'Subbaroyan', 'Affiliation': 'Nevro Corp, Redwood City, CA, USA.'}]",Pain practice : the official journal of World Institute of Pain,['10.1111/papr.12932'] 2692,32615020,Comparison of sevoflurane and propofol on the incidence of postoperative pain and quality of life in patients undergoing total knee arthroplasty with chronic pain before surgery.,"BACKGROUND Propofol and sevoflurane as frequently-used general anesthetics can affect postoperative pain. Our study explored whether the incidence of postoperative pain had a difference in patients with chronic pain undergoing total knee arthroplasty (TKA) anesthetized with sevoflurane or propofol. METHODS Patients were randomly assigned to groups receiving either sevoflurane (Group S, n=50) or propofol (Group P, n=47) for anesthesia maintenance during TKA. The incidences of postoperative pain and quality of life (QoL) were measured by the EQ-5D scale at 1, 3, and 7 days post-operation (DPO), and 1 and 3 months post-operation (MPO). RESULTS At 3 DPO, fewer patients reported moderate pain (p=0.001), and more patients reported no pain (p=0.003) in Group S than that in Group P. At 3 MPO, more patients reported no pain (p=0.04), and fewer patients reported moderate pain (p=0.04) in Group S than in Group P. No significant differences were found in the incidence of postoperative pain between the two groups of patients at the other time-points. The EQ-5D scores were higher in Group S than in Group P (p=0.022), and the difference was 0.15 at most, which was not optimal. The EQ-5D clinical results might be not very significant. CONCLUSIONS Sevoflurane anesthesia may have potential advantages in reducing postoperative pain in patients undergoing TKA with a preoperative VAS score > 4.",2020,"The EQ-5D scores were higher in Group S than in Group P (p=0.022), and the difference was 0.15 at most, which was not optimal.","['patients undergoing total knee arthroplasty with chronic pain before surgery', 'patients undergoing TKA with a preoperative VAS score > 4', 'patients with chronic pain undergoing total knee arthroplasty (TKA) anesthetized with', 'Patients']","['Propofol and sevoflurane', 'sevoflurane and propofol', 'Sevoflurane anesthesia', 'sevoflurane', 'propofol', 'sevoflurane or propofol', 'anesthesia maintenance during TKA']","['no pain', 'EQ-5D scores', 'postoperative pain', 'pain', 'moderate pain', 'postoperative pain and quality of life', 'postoperative pain and quality of life (QoL']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1720436', 'cui_str': 'Under anesthesia'}]","[{'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0024501', 'cui_str': 'Maintenance'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}]","[{'cui': 'C0234225', 'cui_str': 'No pain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0278139', 'cui_str': 'Moderate pain'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",,0.0570544,"The EQ-5D scores were higher in Group S than in Group P (p=0.022), and the difference was 0.15 at most, which was not optimal.","[{'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Yang', 'Affiliation': 'Department of Anesthesiology, First Affiliated Hospital, Anhui Medical University, 218 Jixi Road, Hefei, Anhui, 230022, China.'}, {'ForeName': 'Dan', 'Initials': 'D', 'LastName': 'Zhao', 'Affiliation': 'Department of Anesthesiology, First Affiliated Hospital, Anhui Medical University, 218 Jixi Road, Hefei, Anhui, 230022, China.'}, {'ForeName': 'Xiao-Hui', 'Initials': 'XH', 'LastName': 'Zhang', 'Affiliation': 'Department of Anesthesiology, First Affiliated Hospital, Anhui Medical University, 218 Jixi Road, Hefei, Anhui, 230022, China.'}, {'ForeName': 'Rui-Hong', 'Initials': 'RH', 'LastName': 'Liu', 'Affiliation': 'Department of Anesthesiology, First Affiliated Hospital, Anhui Medical University, 218 Jixi Road, Hefei, Anhui, 230022, China.'}, {'ForeName': 'Guang-Hong', 'Initials': 'GH', 'LastName': 'Xu', 'Affiliation': 'Department of Anesthesiology, First Affiliated Hospital, Anhui Medical University, 218 Jixi Road, Hefei, Anhui, 230022, China.'}, {'ForeName': 'Qi-Ying', 'Initials': 'QY', 'LastName': 'Shen', 'Affiliation': 'Department of Anesthesiology, First Affiliated Hospital, Anhui Medical University, 218 Jixi Road, Hefei, Anhui, 230022, China.'}]",Pain practice : the official journal of World Institute of Pain,['10.1111/papr.12931'] 2693,32615054,Implementation of an attention training programme with a sample of children who have sustained traumatic brain injuries in South Africa: A pilot study.,"This pilot study evaluated the feasibility of implementing an attention-training programme for children who have sustained moderate-to-severe traumatic brain injuries (TBIs) in a South African context. We compared the performance on the programme of children with TBI (TBI Intervention Group) to children who had been diagnosed with Attention Deficit Hyperactivity Disorder (ADHD Intervention Group), a TBI Art group and a TBI No-intervention Group ( n =5 in each group) in this preliminary study. Children in the two Intervention Groups participated in the ""Pay Attention!"" programme for 45 minutes twice a week for 12 weeks. All children were aged 6-8 years and underwent neuropsychological testing pre- and post-intervention. Behavioural data were collected from parents. Children in the ADHD Intervention Group showed individual clinically significant attentional improvements on measures of the Conners' Continuous Performance Test II using the Reliable Change Index (≥ 2.58 SD). Despite mixed results, the pilot study demonstrates that implementing a cognitive rehabilitation programme in South Africa is feasible and necessary, despite limited infrastructure and access to resources.",2020,Children in the ADHD Intervention Group showed individual clinically significant attentional improvements on measures of the Conners' Continuous Performance Test II using the Reliable Change Index (≥ 2.58 SD).,"['children who have sustained traumatic brain injuries in South Africa', 'children who have sustained moderate-to-severe traumatic brain injuries (TBIs) in a South African context', 'All children were aged 6-8 years and underwent neuropsychological testing pre- and post-intervention', 'children with TBI (TBI Intervention Group) to children who had been diagnosed with Attention Deficit Hyperactivity Disorder (ADHD Intervention Group), a']","['cognitive rehabilitation programme', 'attention training programme', 'Pay Attention', 'TBI Art group and a TBI No-intervention Group', 'attention-training programme']","[""individual clinically significant attentional improvements on measures of the Conners' Continuous Performance Test II using the Reliable Change Index""]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C0876926', 'cui_str': 'Traumatic brain injury'}, {'cui': 'C0037712', 'cui_str': 'South Africa'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0027567', 'cui_str': 'African race'}, {'cui': 'C0449255', 'cui_str': 'Context'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0027902', 'cui_str': 'Neuropsychological testing'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0043162', 'cui_str': 'Total body irradiation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1263846', 'cui_str': 'Attention deficit hyperactivity disorder'}]","[{'cui': 'C0870303', 'cui_str': 'Cognitive rehabilitation'}, {'cui': 'C0556509', 'cui_str': 'Attention training'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0043162', 'cui_str': 'Total body irradiation'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",,0.0690508,Children in the ADHD Intervention Group showed individual clinically significant attentional improvements on measures of the Conners' Continuous Performance Test II using the Reliable Change Index (≥ 2.58 SD).,"[{'ForeName': 'Talia H', 'Initials': 'TH', 'LastName': 'Lanesman', 'Affiliation': 'ACSENT Laboratory, Department of Psychology, University of Cape Town, Rondebosch, South Africa.'}, {'ForeName': 'Leigh E', 'Initials': 'LE', 'LastName': 'Schrieff', 'Affiliation': 'ACSENT Laboratory, Department of Psychology, University of Cape Town, Rondebosch, South Africa.'}]",Neuropsychological rehabilitation,['10.1080/09602011.2020.1782233'] 2694,32615109,"Liver transplantation in hepatocellular carcinoma after tumour downstaging (XXL): a randomised, controlled, phase 2b/3 trial.","BACKGROUND Indications for liver transplantation for hepatocellular carcinoma are evolving and so-called expanded criteria remain debated. Locoregional therapies are able to downstage hepatocellular carcinoma from beyond to within the Milan criteria. We aimed to investigate the efficacy of liver transplantation after successful hepatocellular carcinoma downstaging. METHODS We did an open-label, multicentre, randomised, controlled trial designed in two phases, 2b and 3, at nine Italian tertiary care and transplantation centres. Patients aged 18-65 years with hepatocellular carcinoma beyond the Milan criteria, absence of macrovascular invasion or extrahepatic spread, 5-year estimated post-transplantation survival of at least 50%, and good liver function (Child-Pugh A-B7) were recruited and underwent tumour downstaging with locoregional, surgical, or systemic therapies according to multidisciplinary decision. After an observation period of 3 months, during which sorafenib was allowed, patients with partial or complete responses according to modified Response Evaluation Criteria in Solid Tumors were randomly assigned (1:1) by an interactive web-response system to liver transplantation or non-transplantation therapies (control group). A block randomisation (block size of 2), stratified by centre and compliance to sorafenib treatment, was applied. Liver transplantation was done with whole or split organs procured from brain-dead donors. The control group received sequences of locoregional and systemic treatment at the time of demonstrated tumour progression. The primary outcomes were 5-year tumour event-free survival for phase 2b and overall survival for phase 3. Analyses were by intention to treat. Organ allocation policy changed during the course of the study and restricted patient accrual to 4 years. This trial is registered with ClinicalTrials.gov, NCT01387503. FINDINGS Between March 1, 2011, and March 31, 2015, 74 patients were enrolled. Median duration of downstaging was 6 months (IQR 4-11). 29 patients dropped out before randomisation and 45 were randomly assigned: 23 to the transplantation group versus 22 to the control group. At data cutoff on July 31, 2019, median follow-up was 71 months (IQR 60-85). 5-year tumour event-free survival was 76·8% (95% CI 60·8-96·9) in the transplantation group versus 18·3% (7·1-47·0) in the control group (hazard ratio [HR] 0·20, 95% CI 0·07-0·57; p=0·003). 5-year overall survival was 77·5% (95% CI 61·9-97·1) in the transplantation group versus 31·2% (16·6-58·5) in the control group (HR 0·32, 95% CI 0·11-0·92; p=0·035). The most common registered grade 3-4 serious adverse events were hepatitis C virus recurrence (three [13%] of 23 patients) and acute transplant rejection (two [9%]) in the transplantation group, and post-embolisation syndrome (two [9%] of 22 patients) in the control group. Treatment-related deaths occurred in four patients: two (8%) of 23 patients in the transplantation group (myocardial infarction and multi-organ failure) versus two (9%) of 22 patients in the control group (liver decompensation). INTERPRETATION Although results must be interpreted with caution owing to the early closing of the trial, after effective and sustained downstaging of eligible hepatocellular carcinomas beyond the Milan criteria, liver transplantation improved tumour event-free survival and overall survival compared with non-transplantation therapies Post-downstaging tumour response could contribute to the expansion of hepatocellular carcinoma transplantation criteria. FUNDING Italian Ministry of Health.",2020,"overall survival was 77·5% (95% CI 61·9-97·1) in the transplantation group versus 31·2% (16·6-58·5) in the control group (HR 0·32, 95% CI 0·11-0·92; p=0·035).","['two phases, 2b and 3, at nine Italian tertiary care and transplantation centres', '29 patients dropped out before randomisation and 45 were randomly assigned: 23 to the transplantation group versus 22 to the control group', 'Between March 1, 2011, and March 31, 2015, 74 patients were enrolled', 'hepatocellular carcinoma after tumour downstaging (XXL', '0·20', 'Patients aged 18-65 years with hepatocellular carcinoma beyond the Milan criteria, absence of macrovascular invasion or extrahepatic spread, 5-year estimated post-transplantation survival of at least 50%, and good liver function (Child-Pugh A-B7) were recruited and underwent tumour downstaging with locoregional, surgical, or systemic therapies according to multidisciplinary decision', 'patients with partial or complete responses according to modified Response Evaluation Criteria in Solid Tumors']","['liver transplantation', 'sorafenib', 'Liver transplantation', 'interactive web-response system to liver transplantation or non-transplantation therapies (control group']","['5-year tumour event-free survival for phase 2b and overall survival', 'overall survival', 'tumour event-free survival', 'hepatitis C virus recurrence', 'acute transplant rejection', 'Median duration of downstaging', '5-year', 'deaths']","[{'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0022275', 'cui_str': 'Italian language'}, {'cui': 'C3494403', 'cui_str': 'Tertiary Care'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1321095', 'cui_str': 'Drop - unit of product usage'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C2239176', 'cui_str': 'Hepatocellular carcinoma'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0332197', 'cui_str': 'Absent'}, {'cui': 'C1269955', 'cui_str': 'Tumour invasion'}, {'cui': 'C0332261', 'cui_str': 'Spreading'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0232741', 'cui_str': 'Liver function'}, {'cui': 'C4050412', 'cui_str': 'Child-Pugh score'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0242479', 'cui_str': 'Interdisciplinary Studies'}, {'cui': 'C0728938', 'cui_str': 'Partial'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1709926', 'cui_str': 'RECIST'}]","[{'cui': 'C0023911', 'cui_str': 'Transplantation of liver'}, {'cui': 'C1516119', 'cui_str': 'sorafenib'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0040732', 'cui_str': 'Transplantation'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0079500', 'cui_str': 'Hepacivirus'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0018129', 'cui_str': 'Graft rejection'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",74.0,0.208689,"overall survival was 77·5% (95% CI 61·9-97·1) in the transplantation group versus 31·2% (16·6-58·5) in the control group (HR 0·32, 95% CI 0·11-0·92; p=0·035).","[{'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'Mazzaferro', 'Affiliation': 'Department of Oncology and Hemato-Oncology, University of Milan, Milan, Italy; HPB Surgery, Hepatology and Liver Transplantation, Fondazione IRCCS Istituto Nazionale Tumori di Milano, Milan, Italy. Electronic address: vincenzo.mazzaferro@istitutotumori.mi.it.'}, {'ForeName': 'Davide', 'Initials': 'D', 'LastName': 'Citterio', 'Affiliation': 'HPB Surgery, Hepatology and Liver Transplantation, Fondazione IRCCS Istituto Nazionale Tumori di Milano, Milan, Italy.'}, {'ForeName': 'Sherrie', 'Initials': 'S', 'LastName': 'Bhoori', 'Affiliation': 'HPB Surgery, Hepatology and Liver Transplantation, Fondazione IRCCS Istituto Nazionale Tumori di Milano, Milan, Italy.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Bongini', 'Affiliation': 'HPB Surgery, Hepatology and Liver Transplantation, Fondazione IRCCS Istituto Nazionale Tumori di Milano, Milan, Italy.'}, {'ForeName': 'Rosalba', 'Initials': 'R', 'LastName': 'Miceli', 'Affiliation': 'Clinical Epidemiology and Trial Organization, Department of Applied Research and Technological Development, Fondazione IRCCS Istituto Nazionale Tumori di Milano, Milan, Italy.'}, {'ForeName': 'Luciano', 'Initials': 'L', 'LastName': 'De Carlis', 'Affiliation': 'General Surgery and Abdominal Transplantation Unit, Hepatology, University of Milano-Bicocca andNiguarda-CàGranda Hospital, Milan, Italy.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Colledan', 'Affiliation': 'Department of Organ Failure and Transplantation, Gastroenterology, Hepatology and Liver Transplantation, Ospedale Papa Giovanni XXIII, Bergamo, Italy.'}, {'ForeName': 'Mauro', 'Initials': 'M', 'LastName': 'Salizzoni', 'Affiliation': 'General Surgery 2U and Liver Transplantation Center, University of Turin, AOU Cittàdella Salute e della Scienza di Torino, Turin, Italy.'}, {'ForeName': 'Renato', 'Initials': 'R', 'LastName': 'Romagnoli', 'Affiliation': 'General Surgery 2U and Liver Transplantation Center, University of Turin, AOU Cittàdella Salute e della Scienza di Torino, Turin, Italy.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Antonelli', 'Affiliation': ""Liver Transplant Unit and Gastroenterology Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, University of Milan, Milan, Italy.""}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Vivarelli', 'Affiliation': 'Hepatobiliary and Abdominal Transplantation Surgery, Hepatology, Department of Experimental and Clinical Medicine, Polytechnic University of Marche, Ancona, Italy.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Tisone', 'Affiliation': 'Department of Surgical Sciences and Medical Sciences University of Rome-Tor Vergata, Rome, Italy.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Rossi', 'Affiliation': 'Department of General Surgery and Organ Transplantation, Sapienza University, Rome, Italy.'}, {'ForeName': 'Salvatore', 'Initials': 'S', 'LastName': 'Gruttadauria', 'Affiliation': 'Abdominal Surgery and Organ Transplantation Unit, Department for the Treatment and Study of Abdominal Diseases and Abdominal Transplantation, ISMETT, Palermo, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Di Sandro', 'Affiliation': 'General Surgery and Abdominal Transplantation Unit, Hepatology, University of Milano-Bicocca andNiguarda-CàGranda Hospital, Milan, Italy.'}, {'ForeName': 'Riccardo', 'Initials': 'R', 'LastName': 'De Carlis', 'Affiliation': 'General Surgery and Abdominal Transplantation Unit, Hepatology, University of Milano-Bicocca andNiguarda-CàGranda Hospital, Milan, Italy.'}, {'ForeName': 'Maria Grazia', 'Initials': 'MG', 'LastName': 'Lucà', 'Affiliation': 'Department of Organ Failure and Transplantation, Gastroenterology, Hepatology and Liver Transplantation, Ospedale Papa Giovanni XXIII, Bergamo, Italy.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'De Giorgio', 'Affiliation': 'Department of Organ Failure and Transplantation, Gastroenterology, Hepatology and Liver Transplantation, Ospedale Papa Giovanni XXIII, Bergamo, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Mirabella', 'Affiliation': 'General Surgery 2U and Liver Transplantation Center, University of Turin, AOU Cittàdella Salute e della Scienza di Torino, Turin, Italy.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Belli', 'Affiliation': 'General Surgery and Abdominal Transplantation Unit, Hepatology, University of Milano-Bicocca andNiguarda-CàGranda Hospital, Milan, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Fagiuoli', 'Affiliation': 'Department of Organ Failure and Transplantation, Gastroenterology, Hepatology and Liver Transplantation, Ospedale Papa Giovanni XXIII, Bergamo, Italy.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Martini', 'Affiliation': 'General Surgery 2U and Liver Transplantation Center, University of Turin, AOU Cittàdella Salute e della Scienza di Torino, Turin, Italy.'}, {'ForeName': 'Massimo', 'Initials': 'M', 'LastName': 'Iavarone', 'Affiliation': ""Liver Transplant Unit and Gastroenterology Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, University of Milan, Milan, Italy.""}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Svegliati Baroni', 'Affiliation': 'Hepatobiliary and Abdominal Transplantation Surgery, Hepatology, Department of Experimental and Clinical Medicine, Polytechnic University of Marche, Ancona, Italy.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Angelico', 'Affiliation': 'Department of Surgical Sciences and Medical Sciences University of Rome-Tor Vergata, Rome, Italy.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Ginanni Corradini', 'Affiliation': 'Department of General Surgery and Organ Transplantation, Sapienza University, Rome, Italy.'}, {'ForeName': 'Riccardo', 'Initials': 'R', 'LastName': 'Volpes', 'Affiliation': 'Abdominal Surgery and Organ Transplantation Unit, Department for the Treatment and Study of Abdominal Diseases and Abdominal Transplantation, ISMETT, Palermo, Italy.'}, {'ForeName': 'Luigi', 'Initials': 'L', 'LastName': 'Mariani', 'Affiliation': 'Clinical Epidemiology and Trial Organization, Department of Applied Research and Technological Development, Fondazione IRCCS Istituto Nazionale Tumori di Milano, Milan, Italy.'}, {'ForeName': 'Enrico', 'Initials': 'E', 'LastName': 'Regalia', 'Affiliation': 'HPB Surgery, Hepatology and Liver Transplantation, Fondazione IRCCS Istituto Nazionale Tumori di Milano, Milan, Italy.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Flores', 'Affiliation': 'HPB Surgery, Hepatology and Liver Transplantation, Fondazione IRCCS Istituto Nazionale Tumori di Milano, Milan, Italy.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Droz Dit Busset', 'Affiliation': 'HPB Surgery, Hepatology and Liver Transplantation, Fondazione IRCCS Istituto Nazionale Tumori di Milano, Milan, Italy.'}, {'ForeName': 'Carlo', 'Initials': 'C', 'LastName': 'Sposito', 'Affiliation': 'Department of Oncology and Hemato-Oncology, University of Milan, Milan, Italy; HPB Surgery, Hepatology and Liver Transplantation, Fondazione IRCCS Istituto Nazionale Tumori di Milano, Milan, Italy.'}]",The Lancet. Oncology,['10.1016/S1470-2045(20)30224-2'] 2695,32615331,Fluorescence imaging of the ureter in minimally invasive pelvic surgery.,"STUDY OBJECTIVE Determine near optimal dose, safety, and efficacy of nerindocianine in pelvic ureter detection with near-infrared fluorescence imaging in women undergoing minimally invasive pelvic surgery with three FDA-cleared imaging systems. DESIGN An open label, phase 1/2a study SETTING: University of Alabama - Birmingham PATIENTS: Forty-one female subjects undergoing minimally invasive gynecological surgery. INTERVENTIONS Subjects received a single dose of nerindocianine sodium, starting at 0.06 mg/kg body weight and increased/decreased until near optimal dose was determined (Part A). Examine the degree of concordance between endoscopic and robotic devices (Part B). MEASUREMENTS AND MAIN RESULTS Part A: Composite scores were collected every 10 minutes for 30 minutes, and then every 15 minutes through 90 minutes using a scale measuring anatomy/laterality of ureter visualization. In Part B (paired imaging system efficacy), 2 cohorts of 8 subjects each received the near optimal dose. Composite scores for visualization of the ureter were collected at 10 and 30 minutes post-infusion with the Firefly Imaging System and either the PINPOINT or 1588 AIM endoscope. Composite scores were compared to examine the degree of concordance between devices. Part A, 25 total subjects enrolled in dosing Groups 1, 2, and 3 (0.06, 0.12, and 0.045 mg/kg, respectively). Median time to first ureter visualization was 10 min (all groups). Nerindocianine 0.06 mg/kg and 0.12 mg/kg groups had longer length of time of visualization compared to the 0.045 mg/kg group, resulting in selection of 0.06 mg/kg as the near-optimal dose. Part B enrolled 16 total subjects in two groups dosed at 0.06 mg/kg. Efficacy analysis showed no statistically significant difference in composite scores with Firefly vs PINPOINT or 1588 AIM. CONCLUSION Nerindocianine was well-tolerated with visualization of the ureter demonstrated in 88.9% of subjects through 90 minutes post dosing. No meaningful visualization differences were observed amongst FDA-cleared surgical imaging systems used.",2020,Nerindocianine was well-tolerated with visualization of the ureter demonstrated in 88.9% of subjects through 90 minutes post dosing.,"['women undergoing minimally invasive pelvic surgery with three FDA-cleared imaging systems', '25 total subjects enrolled in dosing Groups 1, 2, and 3 (0.06, 0.12, and 0.045 mg/kg, respectively', 'minimally invasive pelvic surgery', ' University of Alabama ', 'Forty-one female subjects undergoing minimally invasive gynecological surgery', 'Part B enrolled 16 total subjects in two groups dosed at 0.06 mg/kg']","['nerindocianine sodium', 'Nerindocianine', 'endoscopic and robotic devices (Part B', 'nerindocianine']","['longer length of time of visualization', 'Median time to first ureter visualization', 'composite scores']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0030797', 'cui_str': 'Pelvic'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0041714', 'cui_str': 'United States Food, Drug Administration'}, {'cui': 'C0521097', 'cui_str': 'Cleared by'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C4517412', 'cui_str': '0.06'}, {'cui': 'C4517426', 'cui_str': '0.12'}, {'cui': 'C4517410', 'cui_str': '0.045'}, {'cui': 'C0439272', 'cui_str': 'ug/g'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0001895', 'cui_str': 'Alabama'}, {'cui': 'C0038902', 'cui_str': 'Operation on female genital organs'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0035785', 'cui_str': 'Robotics'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]","[{'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0041951', 'cui_str': 'Ureteric'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0360639,Nerindocianine was well-tolerated with visualization of the ureter demonstrated in 88.9% of subjects through 90 minutes post dosing.,"[{'ForeName': 'Kenneth H', 'Initials': 'KH', 'LastName': 'Kim', 'Affiliation': 'University of Alabama at Birmingham, 1700 6th Avenue South, UAB Division of Gynecologic Oncology, WIC Room 10250, Birmingham, AL, 35233, USA.'}, {'ForeName': 'John L', 'Initials': 'JL', 'LastName': 'Johnson', 'Affiliation': 'University of Alabama at Birmingham, 1700 6th Avenue South, UAB Division of Gynecologic Oncology, WIC Room 10250, Birmingham, AL, 35233, USA.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Elliott', 'Affiliation': 'University of Alabama at Birmingham, 1700 6th Avenue South, UAB Division of Gynecologic Oncology, WIC Room 10250, Birmingham, AL, 35233, USA.'}, {'ForeName': 'Jonathan D', 'Initials': 'JD', 'LastName': 'Boone', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Tennessee Medical Center Knoxville, Graduate School of Medicine Knoxville, Tennessee.'}, {'ForeName': 'Charles A', 'Initials': 'CA', 'LastName': 'Leath', 'Affiliation': 'University of Alabama at Birmingham, 1700 6th Avenue South, UAB Division of Gynecologic Oncology, WIC Room 10250, Birmingham, AL, 35233, USA.'}, {'ForeName': 'Joy L', 'Initials': 'JL', 'LastName': 'Kovar', 'Affiliation': 'Clinical Research and Development, LI-COR, Inc., 4647 Superior Street, Lincoln, NE, 68504, USA.'}, {'ForeName': 'Warner K', 'Initials': 'WK', 'LastName': 'Huh', 'Affiliation': 'University of Alabama at Birmingham, 1700 6th Avenue South, UAB Division of Gynecologic Oncology, WIC Room 10250, Birmingham, AL, 35233, USA. Electronic address: whuh@uabmc.edu.'}]",Journal of minimally invasive gynecology,['10.1016/j.jmig.2020.06.022'] 2696,32615357,Impact of salt substitute and stepwise reduction of salt supply on blood pressure in residents in senior residential facilities: Design and rationale of the DECIDE-Salt trial.,"BACKGROUND High sodium intake has been considered as the leading dietary risk factor for deaths and disability-adjusted life-years among older adults. High-quality randomized trials to evaluate the effects of practical sodium reduction strategies are needed. METHODS The study is a cluster randomized trial with a 2 × 2 factorial design conducted in 48 senior residential facilities in northern China. These facilities are randomly assigned (1:1:1:1) to 1 of 4 groups: stepwise salt supply control (SSSC) in which 5%-10% of the study salt supply in the institutional kitchens will be reduced every 3 months, replacing normal salt with salt substitute (SS); SSSC only; SS only; or neither SSSC nor SS. The interventions last for 2 years with follow-up every 6 months. The primary outcome is the change in systolic blood pressure from baseline to 24 months. Secondary outcomes include the incidence of hyperkalemia, hyponatremia, cardiovascular events, and death. CURRENT STATUS The study has recruited and randomized 48 senior residential facilities with 1,606 participants. Mean age at baseline was 71 years, and 76% are male. Both types of salt intervention were initiated in the study facilities between January and April 2018. CONCLUSION The study is well placed to define the effects of 2 practical and scalable sodium reduction strategies for blood pressure reduction and will provide important new data about safety of these strategies among older adults in China.",2020,"Secondary outcomes include the incidence of hyperkalemia, hyponatremia, cardiovascular events, and death. ","['Mean age at baseline was 71\u202fyears, and 76% are male', '48 senior residential facilities with 1,606 participants', 'residents in senior residential facilities', 'older adults in China', '48 senior residential facilities in northern China']","['salt substitute and stepwise reduction of salt supply', 'salt intervention', 'stepwise salt supply control (SSSC', 'normal salt with salt substitute (SS); SSSC only; SS only; or neither SSSC nor SS']","['blood pressure', 'change in systolic blood pressure', 'blood pressure reduction', 'incidence of hyperkalemia, hyponatremia, cardiovascular events, and death']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0035186', 'cui_str': 'Residential Facilities'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0008115', 'cui_str': 'China'}]","[{'cui': 'C0036140', 'cui_str': 'Salts'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205307', 'cui_str': 'Normal'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0020461', 'cui_str': 'Hyperkalemia'}, {'cui': 'C0020625', 'cui_str': 'Hyponatremia'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",48.0,0.0400665,"Secondary outcomes include the incidence of hyperkalemia, hyponatremia, cardiovascular events, and death. ","[{'ForeName': 'Aoming', 'Initials': 'A', 'LastName': 'Jin', 'Affiliation': 'Peking University Clinical Research Institute, Peking University First Hospital, Beijing, China.'}, {'ForeName': 'Kiang', 'Initials': 'K', 'LastName': 'Liu', 'Affiliation': 'Department of Preventive Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Darwin R', 'Initials': 'DR', 'LastName': 'Labarthe', 'Affiliation': 'Department of Preventive Medicine, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.'}, {'ForeName': 'Xiangxian', 'Initials': 'X', 'LastName': 'Feng', 'Affiliation': 'Changzhi Medical College, Shanxi, China.'}, {'ForeName': 'Ruijuan', 'Initials': 'R', 'LastName': 'Zhang', 'Affiliation': ""Xi'an Jiaotong University, Shaanxi, China.""}, {'ForeName': 'Hongxia', 'Initials': 'H', 'LastName': 'Wang', 'Affiliation': 'Hohhot Center for Disease Control and Prevention, Hohhot, Inner Mongolia, China.'}, {'ForeName': 'Qianku', 'Initials': 'Q', 'LastName': 'Qiao', 'Affiliation': 'Yangcheng Ophthalmology Hospital, Shanxi, China.'}, {'ForeName': 'Huijuan', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Peking University Clinical Research Institute, Peking University First Hospital, Beijing, China.'}, {'ForeName': 'Jiayu', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Peking University Clinical Research Institute, Peking University First Hospital, Beijing, China.'}, {'ForeName': 'Pei', 'Initials': 'P', 'LastName': 'Gao', 'Affiliation': 'Department of Epidemiology and Biostatistics, Peking University School of Public Health, Beijing, China.'}, {'ForeName': 'Hai', 'Initials': 'H', 'LastName': 'Fang', 'Affiliation': 'China Center for Health Development Studies, Peking University, Beijing, China.'}, {'ForeName': 'Peifen', 'Initials': 'P', 'LastName': 'Duan', 'Affiliation': 'Changzhi Medical College, Shanxi, China.'}, {'ForeName': 'Yuqi', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ""Xi'an Jiaotong University, Shaanxi, China.""}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Zhang', 'Affiliation': 'Hohhot Center for Disease Control and Prevention, Hohhot, Inner Mongolia, China.'}, {'ForeName': 'Lae', 'Initials': 'L', 'LastName': 'Cao', 'Affiliation': 'Yangcheng Ophthalmology Hospital, Shanxi, China.'}, {'ForeName': 'Bruce', 'Initials': 'B', 'LastName': 'Neal', 'Affiliation': 'The George Institute for Global Health, Australia, Sydney, Australia; The University of Sydney, Sydney, Australia.'}, {'ForeName': 'Junshi', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'National Center for Food Safety Risk Assessment, Beijing, China.'}, {'ForeName': 'Yangfeng', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'Peking University Clinical Research Institute, Peking University First Hospital, Beijing, China; Department of Epidemiology and Biostatistics, Peking University School of Public Health, Beijing, China. Electronic address: wuyf@bjmu.edu.cn.'}]",American heart journal,['10.1016/j.ahj.2020.05.013'] 2697,32615392,The effects of 6 mo of supplementation with probiotics and synbiotics on gut microbiota in the adults with prediabetes: A double blind randomized clinical trial.,"OBJECTIVES The evidence of 16S rRNA genes in the gut microbiota distinguished a higher Firmicutes-to-Bacteroidetes ratio in individuals who were obese and had diabetes than in a healthy cohort. So, it seems that the modulation of intestinal microbial ecology by pro-/pre-/synbiotics may contribute to the progression and prevention of metabolic diseases. The aim of this study was to assess the effects of probiotics and synbiotic supplementation on the modification of the intestinal microbiome in adults with prediabetes. METHODS In a randomized, double-blinded, placebo-controlled clinical trial, 120 patients with prediabetes were randomly assigned to consume 6 g/d of either a placebo containing maltodextrin (control) or multispecies probiotic or inulin-based synbiotic for 6 mo. Fecal samples were obtained at baseline and after 6 mo of supplementation. Dietary intake was assessed throughout the study (at baseline and after 3 and 6 mo). Total energy, macronutrients, and dietary fiber were calculated using a dietary program Nutritionist 4. DNA was extracted from fecal samples and the numbers of Clostridium perfringens (the represent of phylum Firmicutes), Bacteroides fragilis (the representative of Bacteroidetes) and Escherichia coli (as universal bacteria) were determined by quantitative real-time polymerase chain reactions (qPCR). The changes in the relative abundance of the two fecal bacteria before and after supplementation were analyzed and compared within and between groups. RESULTS There were no significant changes in dietary intake during the study. Six mo of supplementation with probiotics resulted in a statistically significant increase in the abundance of the B. fragilis-to-E.coli ratio (mean difference [MD] ± SE 0.47 ± 0.37, P = 0.04) and decrease of the relative proportion of Firmicutes-to-Bacteroidetes representatives (MD ± SE -118.8 ± 114.6, P = 0.02). Synbiotic had no significant effect on the changes in the bacteria. There were no significant differences between the three groups. CONCLUSION The results of this study suggest that manipulation of the human gut microbiome by using probiotics could provide a potential therapeutic approach in the prevention and management of obesity and metabolic disorders such as diabetes.",2020,"Six mo of supplementation with probiotics resulted in a statistically significant increase in the abundance of the B. fragilis-to-E.coli ratio (mean difference [MD] ± SE 0.47 ± 0.37, P = 0.04) and decrease of the relative proportion of Firmicutes-to-Bacteroidetes representatives (MD ± SE -118.8 ± 114.6, P = 0.02).","['120 patients with prediabetes', 'adults with prediabetes']","['dietary program', 'probiotics and synbiotic supplementation', 'placebo containing maltodextrin (control) or multispecies probiotic or inulin-based synbiotic', 'Synbiotic', 'supplementation with probiotics and synbiotics', 'placebo']","['dietary intake', 'gut microbiota', 'bacteria', 'Total energy, macronutrients, and dietary fiber', 'abundance of the B. fragilis-to-E.coli ratio', 'Dietary intake', 'Fecal samples']","[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0271650', 'cui_str': 'Impaired glucose tolerance'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C2936470', 'cui_str': 'Synbiotics'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0065601', 'cui_str': 'maltodextrin'}, {'cui': 'C0021936', 'cui_str': 'Inulin'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C0004611', 'cui_str': 'Bacterium'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C2346926', 'cui_str': 'Macronutrient'}, {'cui': 'C0012173', 'cui_str': 'Dietary fiber'}, {'cui': 'C0014834', 'cui_str': 'Escherichia coli'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}]",120.0,0.249584,"Six mo of supplementation with probiotics resulted in a statistically significant increase in the abundance of the B. fragilis-to-E.coli ratio (mean difference [MD] ± SE 0.47 ± 0.37, P = 0.04) and decrease of the relative proportion of Firmicutes-to-Bacteroidetes representatives (MD ± SE -118.8 ± 114.6, P = 0.02).","[{'ForeName': 'Nazila', 'Initials': 'N', 'LastName': 'Kassaian', 'Affiliation': 'Isfahan Endocrine and Metabolism Research Center, Isfahan University of Medical Sciences, Isfahan, Iran. Electronic address: nkassaian@gmal.com.'}, {'ForeName': 'Awat', 'Initials': 'A', 'LastName': 'Feizi', 'Affiliation': 'Isfahan Endocrine and Metabolism Research Center and Department of Biostatistics and Epidemiology, Isfahan University of Medical Sciences, Isfahan, Iran. Electronic address: awat_feiz@hlth.mui.ac.ir.'}, {'ForeName': 'Soodabeh', 'Initials': 'S', 'LastName': 'Rostami', 'Affiliation': 'Infectious Diseases and Tropical Medicine Research Center, Isfahan University of Medical Sciences, Isfahan, Iran. Electronic address: srostami1876@gmail.com.'}, {'ForeName': 'Ashraf', 'Initials': 'A', 'LastName': 'Aminorroaya', 'Affiliation': 'Isfahan Endocrine and Metabolism Research Center, Isfahan University of Medical Sciences, Isfahan, Iran. Electronic address: aminorroaya@med.mui.ac.ir.'}, {'ForeName': 'Majid', 'Initials': 'M', 'LastName': 'Yaran', 'Affiliation': 'Nosocomial Infection Research Center, Isfahan University of Medical Sciences, Isfahan, Iran. Electronic address: yaranmajid@yahoo.com.'}, {'ForeName': 'Masoud', 'Initials': 'M', 'LastName': 'Amini', 'Affiliation': 'Isfahan Endocrine and Metabolism Research Center, Isfahan University of Medical Sciences, Isfahan, Iran. Electronic address: M_amini@med.mui.ac.ir.'}]","Nutrition (Burbank, Los Angeles County, Calif.)",['10.1016/j.nut.2020.110854'] 2698,32613089,Low dose anti-inflammatory radiotherapy for the treatment of pneumonia by covid-19: A proposal for a multi-centric prospective trial.,"Background COVID-19 is a highly contagious viral infection with high morbidity that is draining health resources. The biggest complication is pneumonia, which has a serious inflammatory component, with no standardized treatment. Low-dose radiation therapy (LD-RT) is non-invasive and has anti-inflammatory effects that can interfere with the inflammatory cascade, thus reducing the severity of associated cytokine release and might be useful in the treatment of respiratory complications caused by COVID-19. Study design and methods This multicentric prospective clinical trial seeks to evaluate the efficacy of bilateral lung LD-RT therapy as a treatment for interstitial pneumonia in patients with COVID-19 for improving respiratory function.This prospective study will have 2 phases: I) an exploratory phase enrolling 10 patients, which will assess the feasibility and efficacy of low-dose lung irradiation, evaluated according to an increase in the PaO2/FiO2 ratio of at least 20% at 48-72 h with respect to the pre-irradiation value. If a minimum efficiency of 30% of the patients is not achieved, the study will not be continued. II) Non-randomized comparative phase in two groups: a control group, which will only receive pharmacological treatment, and an experimental arm with pharmacological treatment and LD-RT. It will include 96 patients, the allocation will be 1: 2, that is, 32 in the control arm and 64 in the experimental arm. The primary end-point will be the efficacy of LD-RT in patients with COVID-19 pneumonia according to an improvement in PaO2/FiO2. Secondary objectives will include the safety of bilateral lung LD-RT, an improvement in the radiology image, overall mortality rates at 15 and 30 days after irradiation and characterizing anti-inflammatory mechanisms of LD-RT by measuring the level of expression of adhesion molecules, anti-inflammatory cytokines and oxidative stress mediators.Trial registration: ClinicalTrial.gov NCT-04380818 https://clinicaltrials.gov/ct2/show/NCT04380818?term=RADIOTHERAPY&cond=COVID&draw=2&rank=4.",2020,"Secondary objectives will include the safety of bilateral lung LD-RT, an improvement in the radiology image, overall mortality rates at 15 and 30 days after irradiation and characterizing anti-inflammatory mechanisms of LD-RT by measuring the level of expression of adhesion molecules, anti-inflammatory cytokines and oxidative stress mediators.","['interstitial pneumonia in patients with COVID-19 for improving respiratory function', '96 patients, the allocation will be 1: 2, that is, 32 in the control arm and 64 in the experimental arm']","['bilateral lung LD-RT therapy', 'Low dose anti-inflammatory radiotherapy', 'Low-dose radiation therapy (LD-RT', 'pharmacological treatment, and an experimental arm with pharmacological treatment and LD-RT']","['level of expression of adhesion molecules, anti-inflammatory cytokines and oxidative stress mediators', 'PaO2/FiO2 ratio', 'safety of bilateral lung LD-RT, an improvement in the radiology image, overall mortality rates', 'PaO2/FiO2', 'efficacy of LD-RT']","[{'cui': 'C0206061', 'cui_str': 'Interstitial pneumonia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]","[{'cui': 'C0225754', 'cui_str': 'Both lungs'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0003209', 'cui_str': 'Antiinflammatory agent'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0007578', 'cui_str': 'Cell Adhesion Molecules'}, {'cui': 'C0003209', 'cui_str': 'Antiinflammatory agent'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0225754', 'cui_str': 'Both lungs'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0034599', 'cui_str': 'Radiology - specialty'}, {'cui': 'C1846009', 'cui_str': 'Intrauterine growth restriction, metaphyseal dysplasia, adrenal hypoplasia congenita, and genital anomaly syndrome'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",96.0,0.0407062,"Secondary objectives will include the safety of bilateral lung LD-RT, an improvement in the radiology image, overall mortality rates at 15 and 30 days after irradiation and characterizing anti-inflammatory mechanisms of LD-RT by measuring the level of expression of adhesion molecules, anti-inflammatory cytokines and oxidative stress mediators.","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Algara', 'Affiliation': 'Department of Radiation Oncology, Hospital del Mar, Autonomous University of Barcelona, Spain.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Arenas', 'Affiliation': 'Department of Radiation Oncology, University Hospital Sant Joan de Reus, Rovira iV irgili University, Tarragona, Spain.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Marin', 'Affiliation': 'Intensive Care Unit, Hospital del Mar, Barcelona, Spain.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Vallverdu', 'Affiliation': 'Intensive Care Unit University Hospital Sant Joan de Reus, Universitat Rovira I Virgili, Tarragona, Spain.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Fernandez-Letón', 'Affiliation': 'Department of Radiation Physics, University Hospital HM Sanchinarro, Madrid, Spain.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Villar', 'Affiliation': 'Department of Infectious Diseases, Hospital del Mar, Barcelona, Spain.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Fabrer', 'Affiliation': 'Department of Geriatric and Palliative Care, University Hospital Sant Joan de Reus, Rovira i Virgili University, Tarragona, Spain.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Rubio', 'Affiliation': 'Department of Radiation Oncology, University Hospital HM Sanchinarro, Madrid, Spain.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Montero', 'Affiliation': 'Department of Radiation Oncology, University Hospital HM Sanchinarro, Madrid, Spain.'}]",Clinical and translational radiation oncology,['10.1016/j.ctro.2020.06.005'] 2699,32613096,3-Year effect of weight loss via severe versus moderate energy restriction on body composition among postmenopausal women with obesity - the TEMPO Diet Trial.,"We have previously shown that a severely energy-restricted diet leads to greater loss of weight, fat, lean mass and bone mineral density (BMD) at 12 months in postmenopausal women with obesity than a moderately energy-restricted diet. We now aim to evaluate whether these effects are sustained longer term (ie, at 36 months). 101 postmenopausal women were randomized to either 12 months of moderate (25 to 35%) energy restriction with a food-based diet (moderate intervention), or 4 months of severe (65 to 75%) energy restriction with a total meal replacement diet followed by moderate energy restriction for 8 months (severe intervention). Body weight and composition were measured at 0, 24 and 36 months. Participants in the severe intervention lost ~1.5 to 1.7 times as much weight, waist circumference, whole-body fat mass and visceral adipose tissue compared to those in the moderate intervention, and were 2.6 times more likely (42% versus 16%) to have lost 10% or more of their initial body weight at 36 months ( P < 0.01 for all). However, those in the severe versus moderate intervention lost ~1.4 times as much whole-body lean mass ( P < 0.01), albeit this was proportional to total weight lost and there was no greater loss of handgrip strength, and they also lost ~2 times as much total hip BMD between 0 and 36 months ( P < 0.05), with this bone loss occurring in the first 12 months. Thus, severe energy restriction is more effective than moderate energy restriction for reducing weight and adiposity in postmenopausal women in the long term (3 years), but attention to BMD loss in the first year is required. Trial registration Australian New Zealand Clinical Trials Registry Reference Number: 12612000651886, anzctr.org.au.",2020,"Participants in the severe intervention lost ~1.5 to 1.7 times as much weight, waist circumference, whole-body fat mass and visceral adipose tissue compared to those in the moderate intervention, and were 2.6 times more likely (42% versus 16%) to have lost 10% or more of their initial body weight at 36 months ( P < 0.01 for all).","['postmenopausal women with obesity than a moderately energy-restricted diet', 'postmenopausal women with obesity - the TEMPO Diet Trial', '101 postmenopausal women']","['weight loss via severe versus moderate energy restriction', 'energy restriction with a food-based diet (moderate intervention), or 4 months of severe (65 to 75%) energy restriction with a total meal replacement diet followed by moderate energy restriction for 8 months (severe intervention']","['weight, fat, lean mass and bone mineral density (BMD', 'BMD loss', 'initial body weight', 'handgrip strength', 'body composition', 'weight and adiposity', 'total weight lost', 'weight, waist circumference, whole-body fat mass and visceral adipose tissue', 'total hip BMD', 'Body weight and composition']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0076084', 'cui_str': '2,2,6,6-tetramethyl-4-piperidine-N-oxide'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C1998602', 'cui_str': 'Meals'}, {'cui': 'C0035139', 'cui_str': 'Reimplantation'}, {'cui': 'C0559897', 'cui_str': 'Diet followed'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0205265', 'cui_str': 'Initial'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C1563740', 'cui_str': 'Abdominal Visceral Fat'}, {'cui': 'C0030786', 'cui_str': 'Hip Bone'}, {'cui': 'C0006660', 'cui_str': 'Physiologic Calcification'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0486616', 'cui_str': 'Composition (property)'}]",101.0,0.0291629,"Participants in the severe intervention lost ~1.5 to 1.7 times as much weight, waist circumference, whole-body fat mass and visceral adipose tissue compared to those in the moderate intervention, and were 2.6 times more likely (42% versus 16%) to have lost 10% or more of their initial body weight at 36 months ( P < 0.01 for all).","[{'ForeName': 'Radhika V', 'Initials': 'RV', 'LastName': 'Seimon', 'Affiliation': 'The Boden Collaboration for Obesity, Nutrition, Exercise, and Eating Disorders, Faculty of Medicine and Health, Charles Perkins Centre, The University of Sydney, Camperdown, New South Wales, Australia.'}, {'ForeName': 'Anthony L', 'Initials': 'AL', 'LastName': 'Wild-Taylor', 'Affiliation': 'The Boden Collaboration for Obesity, Nutrition, Exercise, and Eating Disorders, Faculty of Medicine and Health, Charles Perkins Centre, The University of Sydney, Camperdown, New South Wales, Australia.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'McClintock', 'Affiliation': 'The Boden Collaboration for Obesity, Nutrition, Exercise, and Eating Disorders, Faculty of Medicine and Health, Charles Perkins Centre, The University of Sydney, Camperdown, New South Wales, Australia.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Harper', 'Affiliation': 'The Boden Collaboration for Obesity, Nutrition, Exercise, and Eating Disorders, Faculty of Medicine and Health, Charles Perkins Centre, The University of Sydney, Camperdown, New South Wales, Australia.'}, {'ForeName': 'Alice A', 'Initials': 'AA', 'LastName': 'Gibson', 'Affiliation': 'The Boden Collaboration for Obesity, Nutrition, Exercise, and Eating Disorders, Faculty of Medicine and Health, Charles Perkins Centre, The University of Sydney, Camperdown, New South Wales, Australia.'}, {'ForeName': 'Nathan A', 'Initials': 'NA', 'LastName': 'Johnson', 'Affiliation': 'The Boden Collaboration for Obesity, Nutrition, Exercise, and Eating Disorders, Faculty of Medicine and Health, Charles Perkins Centre, The University of Sydney, Camperdown, New South Wales, Australia.'}, {'ForeName': 'Hamish A', 'Initials': 'HA', 'LastName': 'Fernando', 'Affiliation': 'The Boden Collaboration for Obesity, Nutrition, Exercise, and Eating Disorders, Faculty of Medicine and Health, Charles Perkins Centre, The University of Sydney, Camperdown, New South Wales, Australia.'}, {'ForeName': 'Tania P', 'Initials': 'TP', 'LastName': 'Markovic', 'Affiliation': 'The Boden Collaboration for Obesity, Nutrition, Exercise, and Eating Disorders, Faculty of Medicine and Health, Charles Perkins Centre, The University of Sydney, Camperdown, New South Wales, Australia.'}, {'ForeName': 'Jacqueline R', 'Initials': 'JR', 'LastName': 'Center', 'Affiliation': ""Bone Biology Program, Garvan Institute of Medical Research, St Vincent's Hospital Clinical School, University of New South Wales, Sydney, New South Wales, Australia.""}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Franklin', 'Affiliation': 'Metabolism & Obesity Services, Royal Prince Alfred Hospital, Camperdown, New South Wales, Australia.'}, {'ForeName': 'Peter Y', 'Initials': 'PY', 'LastName': 'Liu', 'Affiliation': 'Division of Endocrinology, Department of Medicine, Harbor-University of California Los Angeles Medical Center and Los Angeles BioMedical Research Institute, Los Angeles.'}, {'ForeName': 'Stuart M', 'Initials': 'SM', 'LastName': 'Grieve', 'Affiliation': 'Imaging and Phenotyping Laboratory, Faculty of Medicine and Health, Charles Perkins Centre, The University of Sydney, Camperdown, New South Wales, Australia.'}, {'ForeName': 'Jim', 'Initials': 'J', 'LastName': 'Lagopoulos', 'Affiliation': 'Sunshine Coast Mind and Neuroscience-Thompson Institute, University of the Sunshine Coast, Queensland, Australia.'}, {'ForeName': 'Ian D', 'Initials': 'ID', 'LastName': 'Caterson', 'Affiliation': 'The Boden Collaboration for Obesity, Nutrition, Exercise, and Eating Disorders, Faculty of Medicine and Health, Charles Perkins Centre, The University of Sydney, Camperdown, New South Wales, Australia.'}, {'ForeName': 'Nuala M', 'Initials': 'NM', 'LastName': 'Byrne', 'Affiliation': 'School of Health Sciences, College of Health and Medicine, University of Tasmania, Launceston, Tasmania, Australia.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Sainsbury', 'Affiliation': 'School of Human Sciences, Faculty of Science, The University of Western Australia, Crawley, Western Australia, Australia.'}]",Heliyon,['10.1016/j.heliyon.2020.e04007'] 2700,32613097,Portion perfection and Emotional Freedom Techniques to assist bariatric patients post surgery: A randomised control trial.,"Background Although significant health improvements are indicated from weight-loss following bariatric surgery, many individuals are unable to lose weight or maintain their weight-loss. The current study aimed to assess whether post-surgery care comprising Emotional Freedom Techniques (EFT), an emerging energy psychology intervention, combined with a behaviour-based nutrition and portion control eating plan in an online self-guided delivery would aid weight-loss and maintenance in bariatric patients. Methods A 6-month randomised controlled parallel-group trial. Participants ( N = 343; aged 21-69 years; BMI ≥30 kg/m 2 ) had undergone bariatric surgery (12 + months prior) and were randomly assigned to one of three treatment groups: Portion Perfection for Bariatric Patients (PPBP; n = 109), PPBP combined with an eight-week online self-paced EFT treatment ( n = 107), and a treatment as usual (TAU) control ( n = 127). Participants completed measures of BMI, emotional eating, uncontrolled eating, food cravings, and self-esteem at 8-week post-treatment ( n = 158) and 6-month follow-up ( n = 109). Results Mixed-design analyses of variances were conducted to examine the effect of the interventions on outcome measures (pre-intervention, 8-week post-intervention, and 6-month follow-up). Emotional eating decreased significantly from pre-intervention to post-intervention for the PPBP and PPBP with EFT groups, and at 6-month follow-up for the TAU group only. There were no statistically significant between-group differences in other outcome variables. However, at 6-months the PPBP with EFT group experienced the greatest improvements in emotional eating (-16.33%), uncontrolled eating (-9.36%), and self-esteem (+4.43%), compared to PPBP only or TAU. Conclusion The effect of EFT combined with the eating plan on psychological variables was largely inconsistent with prior research and discussion of how this may be optimised in future trials is discussed. Clinical trial registration ACTRN12616001257459.",2020,"Emotional eating decreased significantly from pre-intervention to post-intervention for the PPBP and PPBP with EFT groups, and at 6-month follow-up for the TAU group only.","['bariatric patients post surgery', 'bariatric patients', 'Participants ( N = 343; aged 21-69 years; BMI ≥30 kg/m 2 ) had undergone bariatric surgery (12 + months prior']","['EFT', 'post-surgery care comprising Emotional Freedom Techniques (EFT), an emerging energy psychology intervention, combined with a behaviour-based nutrition and portion control eating plan', 'Portion Perfection for Bariatric Patients (PPBP; n = 109), PPBP combined with an eight-week online self-paced EFT treatment']","['uncontrolled eating', 'emotional eating', 'Emotional eating', 'self-esteem', 'BMI, emotional eating, uncontrolled eating, food cravings, and self-esteem']","[{'cui': 'C1450026', 'cui_str': 'Bariatrics'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1456587', 'cui_str': 'Metabolic surgery'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0332152', 'cui_str': 'Before'}]","[{'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C4544573', 'cui_str': 'Surgery care'}, {'cui': 'C0033909', 'cui_str': 'Psychology'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0449719', 'cui_str': 'Part'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}, {'cui': 'C1450026', 'cui_str': 'Bariatrics'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0132309', 'cui_str': 'neutrophil-activating peptide 2, human'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0287990', 'cui_str': 'Furin'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0004135', 'cui_str': 'Ataxia-telangiectasia syndrome'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0036597', 'cui_str': 'Self-esteem'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0872380', 'cui_str': 'Food craving'}]",343.0,0.0955262,"Emotional eating decreased significantly from pre-intervention to post-intervention for the PPBP and PPBP with EFT groups, and at 6-month follow-up for the TAU group only.","[{'ForeName': 'Peta', 'Initials': 'P', 'LastName': 'Stapleton', 'Affiliation': 'Bond University, School of Psychology, 14 University Dr, Robina, QLD, 4226, Australia.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Clark', 'Affiliation': 'Great Ideas in Nutrition, Cnr Dutton Street & Marine Parade, Coolangatta, QLD, 4225, Australia.'}, {'ForeName': 'Debbie', 'Initials': 'D', 'LastName': 'Sabot', 'Affiliation': 'Bond University, School of Psychology, 14 University Dr, Robina, QLD, 4226, Australia.'}, {'ForeName': 'Brett', 'Initials': 'B', 'LastName': 'Carter', 'Affiliation': 'Bond University, School of Psychology, 14 University Dr, Robina, QLD, 4226, Australia.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Leech', 'Affiliation': 'Bond University, School of Psychology, 14 University Dr, Robina, QLD, 4226, Australia.'}]",Heliyon,['10.1016/j.heliyon.2020.e04058'] 2701,32613209,"Free gingival grafts vs mucosal excision in increasing the amount of keratinized mucosa during exposure of submerged orthodontic implants: a comparative, split-mouth study.","OBJECTIVES The aim of the present study was to compare the clinical outcomes after using free gingival grafts (FGGs) and mucosal excision during exposure of submerged orthodontic implants. METHOD AND MATERIALS Bilateral sites in 28 subjects were divided into two groups: In the FGG group, FGG augmentation was performed around the orthodontic implants, and in the mucosal excision group, a periosteal bed was made after mucosal excision to promote attached mucosa with no additional soft-tissue augmentation. Outcomes measured during the course of the study were the width of attached mucosa, soft tissue regrowth, degree of inflammation, oral debris, and shrinkage of the attached mucosa around the orthodontic implants over a period of 3 months. RESULTS FGG was more effective in increasing the width of attached mucosa over simple excision of the mucosa alone (2.87 mm vs 1.5 mm; P = .001). In both the groups, there was minimal postoperative soft tissue regrowth over the orthodontic implants, with no statistical significance difference between them (P > .05). The AM in both the treatment modalities demonstrated significant shrinkage (44% in FGG group vs 68% in mucosal excision group; P = .001). However, sites receiving augmentation showed significantly less inflammation than sites treated with mucosal excision (0.63 vs 1.5; P = .001). There was no statistical difference in oral debri accumulation between both the treatment modalities (P = .43) at the end of study period. CONCLUSION Over a simple mucosal excision, using a FGG results in an uninflamed and immobile band of attached mucosa around an orthodontic implant, which offers greater comfort and stability during its function.",2020,"In both the groups, there was minimal postoperative soft tissue regrowth over the orthodontic implants, with no statistical significance difference between them (P > .05).",['Bilateral sites in 28 subjects'],"['mucosal excision group, a periosteal bed was made after mucosal excision to promote attached mucosa with no additional soft-tissue augmentation', 'FGG group, FGG augmentation', 'FGG', 'free gingival grafts (FGGs) and mucosal excision', 'Free gingival grafts vs mucosal excision']","['width of attached mucosa, soft tissue regrowth, degree of inflammation, oral debris, and shrinkage of the attached mucosa around the orthodontic implants over a period of 3 months', 'width of attached mucosa', 'oral debri accumulation', 'inflammation', 'shrinkage', 'minimal postoperative soft tissue regrowth']","[{'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0205145', 'cui_str': 'Site'}]","[{'cui': 'C0026724', 'cui_str': 'Mucosal'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0442033', 'cui_str': 'Periosteal'}, {'cui': 'C0004914', 'cui_str': 'Bedding'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0225317', 'cui_str': 'Soft tissue'}, {'cui': 'C0332509', 'cui_str': 'Increased size'}, {'cui': 'C0398967', 'cui_str': 'Free soft dentoalveolar tissue graft procedure, including donor site'}]","[{'cui': 'C0487742', 'cui_str': 'Width'}, {'cui': 'C0026724', 'cui_str': 'Mucosal'}, {'cui': 'C0225317', 'cui_str': 'Soft tissue'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0440266', 'cui_str': 'Debris'}, {'cui': 'C0332513', 'cui_str': 'Shrinkage'}, {'cui': 'C0332276', 'cui_str': 'Orthodontic'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}]",28.0,0.023507,"In both the groups, there was minimal postoperative soft tissue regrowth over the orthodontic implants, with no statistical significance difference between them (P > .05).","[{'ForeName': 'Rampalli Viswa', 'Initials': 'RV', 'LastName': 'Chandra', 'Affiliation': ''}, {'ForeName': 'Kidambi', 'Initials': 'K', 'LastName': 'Sneha', 'Affiliation': ''}, {'ForeName': 'Purra', 'Initials': 'P', 'LastName': 'Anvesha', 'Affiliation': ''}]","Quintessence international (Berlin, Germany : 1985)",['10.3290/j.qi.a44893'] 2702,32613224,Effects of HF-rTMS over the left and right DLPFC on proactive and reactive cognitive control.,"Previous research supports the distinction between proactive and reactive control. Although the dorsolateral prefrontal cortex (DLPFC) has been consistently related to these processes, lateralization of proactive and reactive control is still under debate. We manipulated brain activity to investigate the role of the left and right DLPFC in proactive and reactive cognitive control. Using a single-blind, sham-controlled crossover within-subjects design, 25 young healthy females performed the 'AX' Continuous Performance Task after receiving sham versus active High-Frequency repetitive Transcranial Magnetic Stimulation (HF-rTMS) to increase left and right DLPFC activity. RTs and pupillometry were used to assess patterns of proactive and reactive cognitive control and task-related resource allocation respectively. We observed that, compared to sham, HF-rTMS over the left DLPFC increased proactive control. After right DLPFC HF-rTMS, participants showed slower RTs on AX trials, suggesting more reactive control. However, this latter result was not supported by RTs on BX trials (i.e. the trial that specifically assess reactive control). Pupil measures showed a sustained increase in resource allocation after both active left and right HF-rTMS. Our results with RT data provide evidence on the role of the left DLPFC in proactive control and suggest that the right DLPFC is implicated in reactive control.",2020,"We observed that, compared to sham, HF-rTMS over the left DLPFC increased proactive control.",['25 young healthy females'],"[""AX' Continuous Performance Task after receiving sham versus active High-Frequency repetitive Transcranial Magnetic Stimulation (HF-rTMS"", 'HF-rTMS']","['resource allocation', 'proactive and reactive cognitive control']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C4329232', 'cui_str': 'AX-CPT'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0205212', 'cui_str': 'High frequency'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}]","[{'cui': 'C0086914', 'cui_str': 'Allocation of Resources'}, {'cui': 'C0205332', 'cui_str': 'Reactive'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",25.0,0.0182482,"We observed that, compared to sham, HF-rTMS over the left DLPFC increased proactive control.","[{'ForeName': 'Matias', 'Initials': 'M', 'LastName': 'Pulopulos', 'Affiliation': 'Department of Experimental Clinical and Health Psychology, Ghent University, Belgium.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Allaert', 'Affiliation': 'Department of Experimental Clinical and Health Psychology, Ghent University, Belgium.'}, {'ForeName': 'Marie-Anne', 'Initials': 'MA', 'LastName': 'Vanderhasselt', 'Affiliation': 'Department of Experimental Clinical and Health Psychology, Ghent University, Belgium.'}, {'ForeName': 'Alvaro', 'Initials': 'A', 'LastName': 'Sanchez-Lopez', 'Affiliation': 'Department of Personality, Evaluation and Psychological Treatment, Complutense University of Madrid, Spain.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'De Witte', 'Affiliation': 'Department of Experimental Clinical and Health Psychology, Ghent University, Belgium.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Baeken', 'Affiliation': 'Department of Head and Skin, Ghent University, Belgium.'}, {'ForeName': 'Rudi', 'Initials': 'R', 'LastName': 'De Raedt', 'Affiliation': 'Department of Experimental Clinical and Health Psychology, Ghent University, Belgium.'}]",Social cognitive and affective neuroscience,['10.1093/scan/nsaa082'] 2703,32613229,The iCanCope pain self-management application for adolescents with juvenile idiopathic arthritis: a pilot randomized controlled trial.,"OBJECTIVES To evaluate the feasibility and preliminary effectiveness of iCanCope with Pain (iCanCope), a smartphone-based pain self-management program, in adolescents with JIA. iCanCope featured symptom tracking, goal-setting, pain coping skills and social support. METHODS A two-arm pilot randomized controlled trial was used to evaluate the iCanCope app compared with a version with symptom tracking only. Primary (feasibility) outcomes were: participant accrual/attrition rates, success of app deployment, acceptability and adherence. Secondary (preliminary effectiveness) outcomes were: pain intensity, pain-related activity limitations and health-related quality of life. Outcomes were assessed at baseline and 8 weeks. Adherence was defined as the proportion of completed symptom reports: 'low' (≤24%); 'low-moderate' (25-49%); 'high-moderate' (50-75%); or 'high' (76-100%). Linear mixed models were applied for preliminary effectiveness analyses as per intention-to-treat. RESULTS Adolescents (N = 60) were recruited from three paediatric rheumatology centres. Rates of accrual and attrition were 82 and 13%, respectively. Both apps were deployed with high success (over 85%) and were rated as highly acceptable. Adherence was similar for both groups, with most participants demonstrating moderate-to-high adherence. Both groups exhibited a clinically meaningful reduction in pain intensity (≥1 point) that did not statistically differ between groups. There were no significant changes in activity limitations or health-related quality of life. CONCLUSION The iCanCope pilot randomized controlled trial was feasible to implement in a paediatric rheumatology setting. Both apps were deployed successfully, with high acceptability, and were associated with moderate-to-high adherence. Preliminary reductions in pain intensity warrant a future trial to evaluate effectiveness of iCanCope in improving health outcomes in adolescents with JIA. TRIAL REGISTRATION ClinicalTrials.gov identifier: NCT02764346.",2020,"There were no significant changes in activity limitations or health-related quality of life. ","['Adolescents (N\u2009=\u200960) were recruited from three paediatric rheumatology centres', 'adolescents with JIA', 'adolescents with juvenile idiopathic arthritis']","['iCanCope pain self-management application', 'iCanCope with Pain (iCanCope', 'smartphone-based pain self-management program', 'iCanCope']","['pain intensity, pain-related activity limitations and health-related quality of life', 'iCanCope featured symptom tracking, goal-setting, pain coping skills and social support', 'Rates of accrual and attrition', 'pain intensity', 'participant accrual/attrition rates, success of app deployment, acceptability and adherence', 'health outcomes', 'activity limitations or health-related quality of life', 'Adherence']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C1621271', 'cui_str': 'Pediatric rheumatology'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C3495559', 'cui_str': 'Juvenile chronic arthritis'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0086969', 'cui_str': 'Self Management'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0150598', 'cui_str': 'Goal setting'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C0004277', 'cui_str': 'Dental Attrition'}, {'cui': 'C0611285', 'cui_str': 'APP protein, human'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",,0.197165,"There were no significant changes in activity limitations or health-related quality of life. ","[{'ForeName': 'Chitra', 'Initials': 'C', 'LastName': 'Lalloo', 'Affiliation': 'Child Health Evaluative Sciences, The Hospital for Sick Children, Toronto, Ontario.'}, {'ForeName': 'Lauren R', 'Initials': 'LR', 'LastName': 'Harris', 'Affiliation': 'Child Health Evaluative Sciences, The Hospital for Sick Children, Toronto, Ontario.'}, {'ForeName': 'Amos S', 'Initials': 'AS', 'LastName': 'Hundert', 'Affiliation': 'Child Health Evaluative Sciences, The Hospital for Sick Children, Toronto, Ontario.'}, {'ForeName': 'Roberta', 'Initials': 'R', 'LastName': 'Berard', 'Affiliation': ""Division of Rheumatology, Children's Hospital London Health Sciences Centre, London, Ontario.""}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Cafazzo', 'Affiliation': 'Institute of Health Policy, Management & Evaluation, University of Toronto, Toronto, Ontario.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Connelly', 'Affiliation': ""Division of Developmental and Behavioural Health, Children's Mercy Kansas City, Kansas City, MO, USA.""}, {'ForeName': 'Brian M', 'Initials': 'BM', 'LastName': 'Feldman', 'Affiliation': 'Division of Rheumatology, The Hospital for Sick Children, Toronto, Ontario.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Houghton', 'Affiliation': ""Division of Rheumatology, BC Children's Hospital, Vancouver, British Columbia.""}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Huber', 'Affiliation': 'Division of Rheumatology, IWK Health Centre, Halifax, Nova Scotia.'}, {'ForeName': 'Ronald M', 'Initials': 'RM', 'LastName': 'Laxer', 'Affiliation': 'Division of Rheumatology, The Hospital for Sick Children, Toronto, Ontario.'}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Luca', 'Affiliation': ""Section of Pediatric Rheumatology, Alberta Children's Hospital, Calgary, Alberta.""}, {'ForeName': 'Heinrike', 'Initials': 'H', 'LastName': 'Schmeling', 'Affiliation': ""Section of Pediatric Rheumatology, Alberta Children's Hospital, Calgary, Alberta.""}, {'ForeName': 'Lynn', 'Initials': 'L', 'LastName': 'Spiegel', 'Affiliation': 'Division of Rheumatology, The Hospital for Sick Children, Toronto, Ontario.'}, {'ForeName': 'Lori B', 'Initials': 'LB', 'LastName': 'Tucker', 'Affiliation': ""Division of Rheumatology, BC Children's Hospital, Vancouver, British Columbia.""}, {'ForeName': 'Quynh', 'Initials': 'Q', 'LastName': 'Pham', 'Affiliation': 'Institute of Health Policy, Management & Evaluation, University of Toronto, Toronto, Ontario.'}, {'ForeName': 'Cleo C', 'Initials': 'CC', 'LastName': 'Davies-Chalmers', 'Affiliation': 'Child Health Evaluative Sciences, The Hospital for Sick Children, Toronto, Ontario.'}, {'ForeName': 'Jennifer N', 'Initials': 'JN', 'LastName': 'Stinson', 'Affiliation': 'Child Health Evaluative Sciences, The Hospital for Sick Children, Toronto, Ontario.'}]","Rheumatology (Oxford, England)",['10.1093/rheumatology/keaa178'] 2704,32613240,Varying levels of serum estradiol do not alter the timing of the early endometrial secretory transformation.,"STUDY QUESTION Do supraphysiologic estradiol (E2) levels in the ranges attained during normal and high response superovulation cycles modify the onset of endometrial secretory transformation? SUMMARY ANSWER Highly supraphysiologic levels of E2 do not alter the ability of physiologic levels of progesterone (P4) to induce secretory transformation. WHAT IS KNOWN ALREADY Previous studies have demonstrated that premature P4 elevations during IVF cycles are associated with a decrement in clinical pregnancy rates after fresh embryo transfer due to shifts in the window of implantation (WOI). However, alterations in the onset of secretory transformation may not apply uniformly to all patients. High responders with supraphysiologic E2 levels accompanied by similar subtle increases in P4 have not been shown to have decreased sustained implantation rates. This prospective investigation in which whole-genome transcriptomic and methylomic analysis of the endometrium is performed for individual patients under a range of E2 concentrations brings clarity to a long-debated issue. STUDY DESIGN, SIZE, DURATION A randomized, prospective and paired trial was conducted in which 10 participants were enrolled and randomized to the order in which they completed three distinct uterine stimulation cycles, each at a specific E2 concentration: physiologic (∼180 pg/ml), moderately supraphysiologic (600-800 pg/ml) or supraphysiologic (2000 pg/ml). Target E2 ranges were selected to mimic those seen in natural, controlled ovarian stimulation and IVF cycles. E2 valerate was administered in order to maintain stable E2 levels for 12 days followed by intramuscular P4 in oil 10 mg/day for two doses, after which an endometrial biopsy was performed. A total of 30 endometrial biopsies were included in a whole-genome transcriptomic and methylomic analysis. PARTICIPANTS/MATERIALS, SETTING, METHODS Healthy volunteers without a history of infertility were included in this study at a single large infertility center. DNA was isolated from the endometrial biopsy specimens and bisulfite sequencing was performed to construct a methylation array. Differential methylation analysis was conducted based on differences in M-values of individuals across treatment groups for each probe as well as carrying out t-tests. RNA was isolated for RNA-Seq analysis and gene expression values were compared using DESeq2. All analyses were performed in a pairwise fashion to compare among the three stimulation cycles within individuals and secondarily to compare all participants in each of the cycles. MAIN RESULTS AND THE ROLE OF CHANCE The mean peak E2 and P4 levels were 275 pg/ml and 4.17 ng/ml in the physiologic group, 910 pg/ml and 2.69 ng/ml in the moderate group was, and 2043 pg/ml and 2.64 ng/ml in the supraphysiologic group, respectively. Principal component analysis of 834 913 CpG sites was performed on M-values of individuals within the low, moderate and supraphysiologic conditions in a paired approach. There were no differences in genome-wide methylation within participants across E2 groups. A paired analysis revealed that gene expression profiles did not differ within the same individual at each of the three E2 levels. No significant alterations in gene expression as related to endometrial physiology were identified between the low, moderate and supraphysiologic groups in an inter-participant analysis. LIMITATIONS, REASONS FOR CAUTION Although each participant completed a physiologic cycle in which E2 levels were maintained in a range that would simulate a natural cycle, our findings are limited by lack of an unmedicated control to assess if there was a potential effect from E2V. Additionally, our results were obtained in fertile individuals, who may have a different endometrial response compared to an infertile population. Despite the whole genomic endometrial assessment and rigorous, paired study design, the sample size was limited. WIDER IMPLICATIONS OF THE FINDINGS Given that the endometrial response to P4 is unaffected by E2 levels in the supraphysiologic range, diminutions in implantation seen in stimulated cycles may result from embryonic-endometrial dyssynchrony following early P4 elevations or slowly blastulating embryos, which occur independently of the magnitude of the E2 rise. STUDY FUNDING/COMPETING INTEREST(S) This study was funded by the Foundation for Embryonic Competence, Basking Ridge, NJ, USA. Dr E.S. reports consultancy work for The Foundation for Embryonic Competence, Basking Ridge, NJ, USA. The other authors declare no conflict of interests related to this topic. TRIAL REGISTRATION NUMBER NCT02458404.",2020,"No significant alterations in gene expression as related to endometrial physiology were identified between the low, moderate and supraphysiologic groups in an inter-participant analysis. ","['Healthy volunteers without a history of infertility were included in this study at a single large infertility center', '10 participants', 'A total of 30 endometrial biopsies were included in a whole-genome transcriptomic and methylomic analysis']","['specific E2 concentration: physiologic (∼180 pg/ml), moderately supraphysiologic (600-800 pg/ml) or supraphysiologic', 'E2 valerate']","['gene expression profiles', 'genome-wide methylation', 'endometrial physiology', 'Varying levels of serum estradiol', 'mean peak E2 and P4 levels', 'clinical pregnancy rates']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0021359', 'cui_str': 'Sterility'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0404066', 'cui_str': 'Endometrial scraping'}, {'cui': 'C0017428', 'cui_str': 'Genome'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0439297', 'cui_str': 'ng/L'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C3844106', 'cui_str': '800'}, {'cui': 'C0042280', 'cui_str': 'Pentanoates'}]","[{'cui': 'C1449575', 'cui_str': 'Microarray Analysis'}, {'cui': 'C0017428', 'cui_str': 'Genome'}, {'cui': 'C0332464', 'cui_str': 'Widening'}, {'cui': 'C0025723', 'cui_str': 'Methylation'}, {'cui': 'C0031842', 'cui_str': 'Physiology'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0474672', 'cui_str': 'Serum estradiol measurement'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0032975', 'cui_str': 'Pregnancy Rates'}]",10.0,0.203383,"No significant alterations in gene expression as related to endometrial physiology were identified between the low, moderate and supraphysiologic groups in an inter-participant analysis. ","[{'ForeName': 'E K', 'Initials': 'EK', 'LastName': 'Osman', 'Affiliation': 'IVI-RMA New Jersey, Basking Ridge, NJ, USA.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Wang', 'Affiliation': 'The Foundation for Embryonic Competence, Basking Ridge, NJ, USA.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Zhan', 'Affiliation': 'The Foundation for Embryonic Competence, Basking Ridge, NJ, USA.'}, {'ForeName': 'C R', 'Initials': 'CR', 'LastName': 'Juneau', 'Affiliation': 'Audubon Fertility, New Orleans, LA, USA.'}, {'ForeName': 'S J', 'Initials': 'SJ', 'LastName': 'Morin', 'Affiliation': 'IVI-RMA Northern California, San Francisco, CA, USA.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Seli', 'Affiliation': 'IVI-RMA New Jersey, Basking Ridge, NJ, USA.'}, {'ForeName': 'R T', 'Initials': 'RT', 'LastName': 'Scott', 'Affiliation': 'IVI-RMA New Jersey, Basking Ridge, NJ, USA.'}, {'ForeName': 'J M', 'Initials': 'JM', 'LastName': 'Franasiak', 'Affiliation': 'IVI-RMA New Jersey, Basking Ridge, NJ, USA.'}]","Human reproduction (Oxford, England)",['10.1093/humrep/deaa135'] 2705,32613402,"Infant formula with cow's milk fat and prebiotics affects intestinal flora, but not the incidence of infections during infancy in a double-blind randomized controlled trial.","BACKGROUND The postnatal intestinal colonization of human milk-fed and formula-fed infants differs substantially, as does the susceptibility to infectious diseases during infancy. Specific ingredients in human milk, such as prebiotic human milk oligosaccharides and a specifically structured fat composition with high proportion of beta-palmitic acid (beta-PA) promote the growth of intestinal bifidobacteria, which are associated with favorable effects on infants' health. The present study investigates whether addition of prebiotic galactooligosaccharides (GOS) in combination with higher amounts of beta-PA from cow's milk fat in infant formula positively affects gut microbiota and the incidence of infections in formula-fed infants. METHODS In a double-blind controlled trial, formula-fed infants were randomly assigned to either receive an experimental formula containing a higher proportion of beta-PA (20-25%) from natural cow's milk fat, and a prebiotic supplement (0.5 g GOS/100 ml), or a standard infant formula with low beta-PA (< 10%), without prebiotics. A breast-fed reference group was also enrolled. After 12 weeks, fecal samples were collected to determine the proportion of fecal bifidobacteria. The number of infections during the first year of life was recorded. RESULTS After 12 weeks, the proportion of fecal bifidobacteria was significantly higher in infants receiving formula with high beta-PA and GOS compared to control, and was similar to the breast-fed group (medians 8.8%, 2.5%, and 5.0% respectively; p < 0.001). The incidence of gastrointestinal or other infections during the first year of life did not differ between groups. CONCLUSIONS The combination of higher amounts of beta-PA plus GOS increased significantly the proportion of fecal bifidobacteria in formula-fed infants, but did not affect the incidence of infections. TRIAL REGISTRATION The study protocol was registered with Clinical Trials (Protocol Registration and Results System Trial ID: NCT01603719 ) on 05/15/2012 (retrospectively registered).",2020,"After 12 weeks, the proportion of fecal bifidobacteria was significantly higher in infants receiving formula with high beta-PA and GOS compared to control, and was similar to the breast-fed group (medians 8.8%, 2.5%, and 5.0% respectively; p < 0.001).",['formula-fed infants'],"[""experimental formula containing a higher proportion of beta-PA (20-25%) from natural cow's milk fat, and a prebiotic supplement"", 'prebiotic galactooligosaccharides (GOS']","['fecal bifidobacteria', 'proportion of fecal bifidobacteria', 'incidence of infections', 'number of infections', 'incidence of gastrointestinal or other infections']","[{'cui': 'C0204695', 'cui_str': 'Feeding patient'}, {'cui': 'C0021270', 'cui_str': 'Infant'}]","[{'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0330390', 'cui_str': 'Beta'}, {'cui': 'C0030234', 'cui_str': 'Palmitic acid'}, {'cui': 'C0205296', 'cui_str': 'Natural'}, {'cui': 'C3256606', 'cui_str': 'milk fat, cow'}, {'cui': 'C2717875', 'cui_str': 'Prebiotics'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}]","[{'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0237753', 'cui_str': 'Number'}]",,0.274988,"After 12 weeks, the proportion of fecal bifidobacteria was significantly higher in infants receiving formula with high beta-PA and GOS compared to control, and was similar to the breast-fed group (medians 8.8%, 2.5%, and 5.0% respectively; p < 0.001).","[{'ForeName': 'Antonia', 'Initials': 'A', 'LastName': 'Nomayo', 'Affiliation': 'Department of Pediatrics, Evangelisches Waldkrankenhaus Spandau, Stadtrandstr. 555, 13589, Berlin, Germany. Antonia.nomayo@jsd.de.'}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Schwiertz', 'Affiliation': 'Institute of Microecology, Herborn, Germany.'}, {'ForeName': 'Rainer', 'Initials': 'R', 'LastName': 'Rossi', 'Affiliation': 'Department of Pediatrics, Vivantes Klinikum Neukölln, Berlin, Germany.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Timme', 'Affiliation': 'Department of Pediatrics, Vivantes Klinikum Neukölln, Berlin, Germany.'}, {'ForeName': 'Janine', 'Initials': 'J', 'LastName': 'Foster', 'Affiliation': 'Department of Pediatrics, Evangelisches Waldkrankenhaus Spandau, Stadtrandstr. 555, 13589, Berlin, Germany.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Zelenka', 'Affiliation': 'DMK Baby GmbH, Bremen, Germany.'}, {'ForeName': 'Josef', 'Initials': 'J', 'LastName': 'Tvrdik', 'Affiliation': 'Department of Computer Sciences, University of Ostrava, Ostrava, Czech Republic.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Jochum', 'Affiliation': 'Department of Pediatrics, Evangelisches Waldkrankenhaus Spandau, Stadtrandstr. 555, 13589, Berlin, Germany.'}]",Molecular and cellular pediatrics,['10.1186/s40348-020-00098-1'] 2706,32613433,Evaluation of local hemostatic efficacy after dental extractions in patients taking antiplatelet drugs: a randomized clinical trial.,"OBJECTIVES The purpose of this study was to evaluate clinical efficacy of four different local hemostatics in patients taking oral antiplatelet therapy, after multiple dental extractions without discontinuing drugs. MATERIALS AND METHODS Study sample included 102 patients (mean age 64.1 ± 17.4 years) in treatment with oral antiplatelet agents needing multiple dental extractions. After surgery, the sockets were randomly sealing with suture alone (control group), hemostatic plug (HEM), advanced platelet-rich fibrin (A-PRF+), and leukocyte-platelet-rich fibrin (L-PRF). Primary outcomes were post-operative bleeding, wound healing index, and possible complications. Secondary outcomes were correlation between primary outcomes and patient's comorbidities and voluptuous habits. Descriptive statistics, bivariate comparisons, and logistic regression analysis were performed (p < 0.05). RESULTS Both A-PRF+ and L-PRF showed a reduced bleeding risk when compared with suture alone (OR = 0.09, p = 0.001 for A-PRF+; OR = 0.09, p = 0.005 for L-PRF). Only L-PRF showed a reduced risk for incomplete wound healing when compared with the control site (OR = 0.43, p = 0.019). Patients affected by hypertension (OR 3.91, p = 0.015) and diabetes (OR 3.24, p = 0.026) had the highest bleeding risk. Smoking (OR 4.30, p = 0.016) and diabetes (OR 3.79, p = 0.007) interfered with healing process. CONCLUSION L-PRF and A-PRF represent a valid alternative to the traditional hemostatics, reducing post-surgical bleeding and promoting wound healing. CLINICAL RELEVANCE In patients taking antiplatelet drugs, different local hemostatics are useful to control potential post-operative bleeding and to favor wound healing. However, comorbidities and voluptuous habits may increase bleeding risk, interfering with healing process.",2020,"Only L-PRF showed a reduced risk for incomplete wound healing when compared with the control site (OR = 0.43, p = 0.019).","['Study sample included 102 patients (mean age 64.1 ± 17.4 years) in treatment with oral antiplatelet agents needing multiple dental extractions', 'patients taking oral antiplatelet therapy, after multiple dental extractions without discontinuing drugs', 'patients taking antiplatelet drugs']","['suture alone (control group), hemostatic plug (HEM), advanced platelet-rich fibrin (A-PRF+), and leukocyte-platelet-rich fibrin']","['highest bleeding risk', ""patient's comorbidities and voluptuous habits"", 'bleeding risk', 'reduced risk for incomplete wound healing', 'Smoking (OR', 'post-operative bleeding, wound healing index, and possible complications', 'local hemostatic efficacy', 'hypertension']","[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0085826', 'cui_str': 'Antiplatelet agent'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0040440', 'cui_str': 'Tooth extraction'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C1096021', 'cui_str': 'Antiplatelet therapy'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0009068', 'cui_str': 'Closure by suture'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0019116', 'cui_str': 'Hemostatic function'}, {'cui': 'C0182324', 'cui_str': 'Plug'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C4505052', 'cui_str': 'Leukocyte- and Platelet-Rich Fibrin'}, {'cui': 'C0023508', 'cui_str': 'White blood cell count'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009488', 'cui_str': 'Comorbidity'}, {'cui': 'C0018464', 'cui_str': 'Habits'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0205257', 'cui_str': 'Incomplete'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0037369', 'cui_str': 'Smoking'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0016204', 'cui_str': 'Flatus'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0332149', 'cui_str': 'Possible'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C3653417', 'cui_str': 'Local hemostatics'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}]",102.0,0.0402847,"Only L-PRF showed a reduced risk for incomplete wound healing when compared with the control site (OR = 0.43, p = 0.019).","[{'ForeName': 'Ylenia', 'Initials': 'Y', 'LastName': 'Brancaccio', 'Affiliation': 'Department of Health Sciences, School of Dentistry, Magna Graecia University of Catanzaro, Catanzaro, Italy.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Antonelli', 'Affiliation': 'Department of Health Sciences, School of Dentistry, Magna Graecia University of Catanzaro, Catanzaro, Italy.'}, {'ForeName': 'Selene', 'Initials': 'S', 'LastName': 'Barone', 'Affiliation': 'Department of Health Sciences, School of Dentistry, Magna Graecia University of Catanzaro, Catanzaro, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Bennardo', 'Affiliation': 'Department of Health Sciences, School of Dentistry, Magna Graecia University of Catanzaro, Catanzaro, Italy.'}, {'ForeName': 'Leonzio', 'Initials': 'L', 'LastName': 'Fortunato', 'Affiliation': 'Department of Health Sciences, School of Dentistry, Magna Graecia University of Catanzaro, Catanzaro, Italy.'}, {'ForeName': 'Amerigo', 'Initials': 'A', 'LastName': 'Giudice', 'Affiliation': 'Department of Health Sciences, Magna Graecia University of Catanzaro, Viale Europa, 88100, Catanzaro, Italy. a.giudice@unicz.it.'}]",Clinical oral investigations,['10.1007/s00784-020-03420-3'] 2707,32613451,Muscle pain induced by hypertonic saline in the knee extensors decreases single-limb isometric time to task failure.,"PURPOSE Increased nociceptive activity and the experience of exercise-induced pain (EIP) may contribute to fatigue during endurance exercise. To investigate this, a pain model that produces pain similar to EIP and decouples its relationship to exercise intensity is required. This study (1) compared the quality of pain caused by a hypertonic saline injection into the vastus lateralis in resting and exercise conditions, and (2) investigated whether this pain contributes to changes in time to task failure. METHODS On separate days, 18 participants completed a time to task failure at 20% maximal voluntary torque (MVT), a resting hypertonic saline intramuscular injection, and in a further three visits a time to task failure at 10% MVT following injection of isotonic saline, hypertonic saline or a control (no injection). RESULTS In a subset of eligible participants (n = 12), the hypertonic saline combined with 10% MVT produced a qualitative experience of pain (assessed by the McGill Pain Questionnaire) that felt similar to EIP. 10% MVT with hypertonic saline significantly elevated pain intensity in the first 20% of the time to task failure and caused a significantly (P < 0.05) shorter time to task failure (448 ± 240 s) compared with the isotonic saline (605 ± 285 s) and control (514 ± 197 s) conditions. CONCLUSION These findings demonstrate that hypertonic saline increases the intensity of pain during exercise, which results in a faster occurrence of exercise-induced fatigue. These results provide important evidence supporting pain as a limiting factor in endurance performance.",2020,"10% MVT with hypertonic saline significantly elevated pain intensity in the first 20% of the time to task failure and caused a significantly (P < 0.05) shorter time to task failure (448 ± 240 s) compared with the isotonic saline (605 ± 285 s) and control (514 ± 197 s) conditions. ",['18 participants completed a time to task failure at 20'],"['hypertonic saline combined with 10% MVT', 'maximal voluntary torque (MVT), a resting hypertonic saline intramuscular injection', 'isotonic saline, hypertonic saline or a control (no injection', 'exercise-induced pain (EIP', 'isotonic saline', 'hypertonic saline injection', 'hypertonic saline']","['quality of pain', 'knee extensors decreases single-limb isometric time to task failure', 'intensity of pain', 'elevated pain intensity', 'qualitative experience of pain', 'McGill Pain Questionnaire']","[{'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0231174', 'cui_str': 'Failure'}]","[{'cui': 'C0036085', 'cui_str': 'sodium chloride, hypertonic'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0318082', 'cui_str': 'Ruminococcus torques'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0021492', 'cui_str': 'Intramuscular injection'}, {'cui': 'C0454287', 'cui_str': 'Isotonic exercise'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]","[{'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0022206', 'cui_str': 'Isometric exercise'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0205556', 'cui_str': 'Qualitative'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0024985', 'cui_str': 'McGill pain chart questionnaire'}]",,0.144328,"10% MVT with hypertonic saline significantly elevated pain intensity in the first 20% of the time to task failure and caused a significantly (P < 0.05) shorter time to task failure (448 ± 240 s) compared with the isotonic saline (605 ± 285 s) and control (514 ± 197 s) conditions. ","[{'ForeName': 'Samuel A', 'Initials': 'SA', 'LastName': 'Smith', 'Affiliation': 'Endurance Research Group, School of Sport and Exercise Sciences, University of Kent, Chatham, Kent, ME4 4AG, UK.'}, {'ForeName': 'Dominic', 'Initials': 'D', 'LastName': 'Micklewright', 'Affiliation': 'School of Sport, Rehabilitation and Exercise Sciences, University of Essex, Wivenhoe Park, Colchester, UK.'}, {'ForeName': 'Samantha L', 'Initials': 'SL', 'LastName': 'Winter', 'Affiliation': 'Endurance Research Group, School of Sport and Exercise Sciences, University of Kent, Chatham, Kent, ME4 4AG, UK.'}, {'ForeName': 'Alexis R', 'Initials': 'AR', 'LastName': 'Mauger', 'Affiliation': 'Endurance Research Group, School of Sport and Exercise Sciences, University of Kent, Chatham, Kent, ME4 4AG, UK. lex.mauger@gmail.com.'}]",European journal of applied physiology,['10.1007/s00421-020-04425-2'] 2708,32613525,Development and Initial Testing of an mHealth Transitions of Care Intervention for Adults with Schizophrenia-Spectrum Disorders Immediately Following a Psychiatric Hospitalization.,"An important period in the care of patients with schizophrenia-spectrum disorders is when they transition from inpatient to outpatient services and are at increased risk for relapse and rehospitalization. Thus, we developed and examined the initial feasibility, acceptability, and clinical effects of an mHealth transitions of care intervention (Mobile After-Care Support; MACS) in an open trial. Ten adults with schizophrenia-spectrum disorders were recruited during their index psychiatric hospitalization and enrolled prior to discharge. Measures of feasibility, acceptability, and MACS targets were administered at baseline and a 1-month follow-up. Drawing on skills from Cognitive Behavioral Therapy for Psychosis (CBTp), MACS delivered brief assessments of clinically relevant variables, followed by just-in-time interventions for patients starting immediately post-discharge. Individuals completed about one session per day on average as expected. Overall, measures of MACS usability and satisfaction were positive. T-test analyses showed that dysfunctional coping strategies significantly decreased from baseline to 1-month follow-up. Results also revealed statistically significant reductions in psychiatric symptoms over 1-month follow-up. This study demonstrates the feasibility and acceptability of MACS, a new app-based intervention targeting transitions of care for patients with psychosis. The field is turning to the use of mobile technology as a means of augmenting service delivery and providing real-time assessment and intervention for patients at risk. MACS is a promising adjunctive intervention that warrants further testing in a randomized controlled trial.",2020,"This study demonstrates the feasibility and acceptability of MACS, a new app-based intervention targeting transitions of care for patients with psychosis.","['patients with schizophrenia-spectrum disorders', 'Ten adults with schizophrenia-spectrum disorders were recruited during their index psychiatric hospitalization and enrolled prior to discharge', 'patients with psychosis', 'Adults with Schizophrenia-Spectrum Disorders']","['MACS', 'Care Intervention', 'care intervention (Mobile After-Care Support; MACS']","['dysfunctional coping strategies', 'psychiatric symptoms', 'feasibility, acceptability, and MACS targets', 'MACS usability and satisfaction']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0012621', 'cui_str': 'Discharge'}, {'cui': 'C0033975', 'cui_str': 'Psychotic disorder'}]","[{'cui': 'C0009545', 'cui_str': 'Active C5b6789'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0001758', 'cui_str': 'Aftercare'}, {'cui': 'C0183683', 'cui_str': 'Support'}]","[{'cui': 'C0009967', 'cui_str': 'Coping behavior'}, {'cui': 'C0233401', 'cui_str': 'Psychiatric symptom'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0009545', 'cui_str': 'Active C5b6789'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",10.0,0.0587841,"This study demonstrates the feasibility and acceptability of MACS, a new app-based intervention targeting transitions of care for patients with psychosis.","[{'ForeName': 'Ethan', 'Initials': 'E', 'LastName': 'Moitra', 'Affiliation': 'Department of Psychiatry and Human Behavior, Warren Alpert Medical School of Brown University, Providence, RI, 02912, USA. ethan_moitra@brown.edu.'}, {'ForeName': 'Hyun Seon', 'Initials': 'HS', 'LastName': 'Park', 'Affiliation': 'Psychosocial Research Program, Butler Hospital, Providence, RI, 02906, USA.'}, {'ForeName': 'Brandon A', 'Initials': 'BA', 'LastName': 'Gaudiano', 'Affiliation': 'Department of Psychiatry and Human Behavior, Warren Alpert Medical School of Brown University, Providence, RI, 02912, USA.'}]",The Psychiatric quarterly,['10.1007/s11126-020-09792-9'] 2709,32613714,Impact of periodontal therapy on systemic markers of inflammation in patients with metabolic syndrome: a randomized clinical trial.,"AIMS To determine the impact of periodontal treatment on systemic markers of inflammation in patients with metabolic syndrome (MetS) and periodontitis. MATERIAL AND METHODS In this parallel-arm, double blind, randomized controlled clinical trial, 63 patients with MetS and severe periodontitis were randomly assigned to receive intensive periodontal treatment (IPT; scaling and root planing plus azithromycin 500 mg, q.d., for three days) or minimal periodontal treatment (MPT; supragingival professional mechanical plaque removal plus a placebo). The primary outcome was the impact of the tested interventions on hs-CRP serum levels at 6 months. As secondary outcomes, differences in the levels of cytokines, markers of prothrombotic states, carbohydrate and lipids metabolism, as well as blood pressure, were measured at 3 and 6 months after therapy. RESULTS The ITT population consisted on 63 subjects randomly assigned to either MPT (n=31) or IPT (n=32) groups. At baseline, mean hs-CRP was 3.9 mg/L (standard deviation, SD=2.9) and 3.9 mg/L (SD=3.4), respectively, and no significant differences in their cardiometabolic risk profiles were detected between groups. Adjusting for baseline hs-CRP, sex, age, smoking status and body mass index, hs-CRP at 6 months was 1.2 mg/L (95% confidence interval, [CI 0.4; 2.0]; p=0.004) lower in the IPT group than in the MPT group. In the secondary outcomes, significant reductions in IL-1β, TNF-α, HbA1c and blood pressure were observed in the IPT group at 3 months, when compared to the MPT group. CONCLUSION Effective periodontal treatment significantly reduced hs-CRP after 6 months in patients with MetS and severe periodontitis. Periodontal therapy might be useful to reduce cardiovascular risk in these patients. This article is protected by copyright. All rights reserved.",2020,"In the secondary outcomes, significant reductions in IL-1β, TNF-α, HbA1c and blood pressure were observed in the IPT group at 3 months, when compared to the MPT group. ","['patients with metabolic syndrome', 'patients with metabolic syndrome (MetS) and periodontitis', 'patients with MetS and severe periodontitis', '63 patients with MetS and severe periodontitis']","['IPT', 'MPT', 'minimal periodontal treatment (MPT; supragingival professional mechanical plaque removal plus a placebo', 'periodontal treatment', 'Periodontal therapy', 'intensive periodontal treatment (IPT; scaling and root planing plus azithromycin', 'periodontal therapy']","['levels of cytokines, markers of prothrombotic states, carbohydrate and lipids metabolism, as well as blood pressure', 'cardiovascular risk', 'IL-1β, TNF-α, HbA1c and blood pressure', 'cardiometabolic risk profiles', 'systemic markers of inflammation', 'mean hs-CRP', 'hs-CRP serum levels', 'hs-CRP']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0524620', 'cui_str': 'Metabolic syndrome X'}, {'cui': 'C0031099', 'cui_str': 'Periodontitis'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]","[{'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0443254', 'cui_str': 'Mechanical'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0085287', 'cui_str': 'Root planing of tooth'}, {'cui': 'C0052796', 'cui_str': 'Azithromycin'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0598783', 'cui_str': 'Lipid Metabolism'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0229671', 'cui_str': 'Serum'}]",63.0,0.499139,"In the secondary outcomes, significant reductions in IL-1β, TNF-α, HbA1c and blood pressure were observed in the IPT group at 3 months, when compared to the MPT group. ","[{'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Montero', 'Affiliation': 'ETEP (Etiology and Therapy of Periodontal and Peri-implant Diseases) Research Group, University Complutense, Madrid, Spain.'}, {'ForeName': 'Mercedes', 'Initials': 'M', 'LastName': 'López', 'Affiliation': 'ETEP (Etiology and Therapy of Periodontal and Peri-implant Diseases) Research Group, University Complutense, Madrid, Spain.'}, {'ForeName': 'Honorato', 'Initials': 'H', 'LastName': 'Vidal', 'Affiliation': 'Section of Graduate Periodontology. University Complutense, Madrid, Spain.'}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'Martínez', 'Affiliation': 'Section of Graduate Periodontology. University Complutense, Madrid, Spain.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Marrero', 'Affiliation': 'Internal Medicine Department. Fuenlabrada Hospital, Madrid, Spain.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Herrera', 'Affiliation': 'ETEP (Etiology and Therapy of Periodontal and Peri-implant Diseases) Research Group, University Complutense, Madrid, Spain.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Zapatero', 'Affiliation': 'Internal Medicine Department. Fuenlabrada Hospital, Madrid, Spain.'}, {'ForeName': 'Mariano', 'Initials': 'M', 'LastName': 'Sanz', 'Affiliation': 'ETEP (Etiology and Therapy of Periodontal and Peri-implant Diseases) Research Group, University Complutense, Madrid, Spain.'}]","Diabetes, obesity & metabolism",['10.1111/dom.14131'] 2710,32613718,Vitamin D for treatment of non-alcoholic fatty liver disease detected by transient elastography: a randomised double-blind placebo controlled trial.,"AIM To evaluate effects of vitamin D on transient elastography (TE, FibroScan®) indices of liver steatosis [controlled attenuation parameter (CAP)] and fibrosis [liver stiffness measurement (LSM)] in adults with non-alcoholic fatty liver disease (NAFLD). PATIENTS AND METHODS In this randomized (2:1), double-blind single-centre 12-month trial (ClinicalTrials.gov NCT04038853) patients with NAFLD were treated with vitamin D (1000 IU/day) (n=201) or a matching placebo (n=110). Two co-primary outcomes were changes in CAP and LSM after 360 days of treatment vs. baseline. Two main secondary outcomes were CAP/LSM changes after 180 days of treatment. RESULTS Both CAP and LSM gradually decreased in vitamin D-treated patients and slightly increased in the placebo arm. Vitamin D was superior to placebo for both primary outcomes (mean differences in CAP and LSM changes -49.5 dB/m [95%CI -59.5 to -39.4] and -0.72 kPa [95%CI -1.43 to 0.00], respectively) and both secondary outcomes (-22.1 dB/m [-32.1 to -12.1] and -0.89 kPa [-1.61 to -0.17], respectively). Of a number of exploratory outcomes (change at 12 months vs. baseline), vitamin D reduced serum uric acid (-17.9 μmol/L [-30.6 to -5.2]), gamma glutamyl transferase (-8.9 IU/L [-15.5 to - 2.3)] and fasting serum insulin levels (-5.1 pmol/L [-9.3 to -0.8]) as well as the homeostatic model assessment of insulin resistance index (-1.6 [-3.1 to -0.2]) (false discovery rate [FDR=5%]-adjusted P-values between 0.0572 and 0.0952). CONCLUSION Low-medium dose supplementation of vitamin D (1000 IU/day) over 12 months reduces TE indices of liver steatosis (CAP) and fibrosis (LSM) in NAFLD patients. This article is protected by copyright. All rights reserved.",2020,"Vitamin D was superior to placebo for both primary outcomes (mean differences in CAP and LSM changes -49.5 dB/m [95%CI -59.5 to -39.4] and -0.72 kPa [95%CI -1.43 to 0.00], respectively) and both secondary outcomes (-22.1 dB/m [-32.1 to -12.1] and -0.89 kPa [-1.61 to -0.17], respectively).","['patients with NAFLD', 'adults with non-alcoholic fatty liver disease (NAFLD', 'NAFLD patients']","['Vitamin D', 'vitamin D', 'matching placebo', 'placebo']","['CAP/LSM changes', 'changes in CAP and LSM', 'homeostatic model assessment of insulin resistance index', 'gamma glutamyl transferase', 'TE indices of liver steatosis (CAP) and fibrosis (LSM', 'transient elastography (TE, FibroScan®) indices of liver steatosis [controlled attenuation parameter (CAP)] and fibrosis [liver stiffness measurement (LSM', 'fasting serum insulin levels', 'serum uric acid', 'CAP and LSM']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0023884', 'cui_str': 'Liver structure'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0017040', 'cui_str': 'Gamma-glutamyltransferase'}, {'cui': 'C0015695', 'cui_str': 'Fatty Liver'}, {'cui': 'C0016059', 'cui_str': 'Fibrosis'}, {'cui': 'C2748260', 'cui_str': 'Transient elastography'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0428357', 'cui_str': 'Serum insulin measurement'}, {'cui': 'C0455272', 'cui_str': 'Serum urate measurement'}]",,0.800459,"Vitamin D was superior to placebo for both primary outcomes (mean differences in CAP and LSM changes -49.5 dB/m [95%CI -59.5 to -39.4] and -0.72 kPa [95%CI -1.43 to 0.00], respectively) and both secondary outcomes (-22.1 dB/m [-32.1 to -12.1] and -0.89 kPa [-1.61 to -0.17], respectively).","[{'ForeName': 'Lukenda Zanko', 'Initials': 'LZ', 'LastName': 'Vesna', 'Affiliation': 'Department of Internal Medicine, General Hospital ""Josip Benčević"", Slavonski Brod, Croatia.'}, {'ForeName': 'Domislovic', 'Initials': 'D', 'LastName': 'Viktor', 'Affiliation': 'Department for Gastroenterology and Hepatology, University Hospital Center Zagreb, Zagreb, Croatia.'}, {'ForeName': 'Trkulja', 'Initials': 'T', 'LastName': 'Vladimir', 'Affiliation': 'Department of Pharmacology, School of Medicine Zagreb, Zagreb, Croatia.'}, {'ForeName': 'Krznaric-Zrnic', 'Initials': 'KZ', 'LastName': 'Irena', 'Affiliation': 'Department of Gastroenterology, University Hospital Center Rijeka, Rijeka, Croatia.'}, {'ForeName': 'Turk-Wensveen', 'Initials': 'TW', 'LastName': 'Tamara', 'Affiliation': 'Department of Endocrinology, University Hospital Center Rijeka, Rijeka, Croatia.'}, {'ForeName': 'Krznaric', 'Initials': 'K', 'LastName': 'Zeljko', 'Affiliation': 'Department for Gastroenterology and Hepatology, University Hospital Center Zagreb, Zagreb, Croatia.'}, {'ForeName': 'Filipec Kanizaj', 'Initials': 'FK', 'LastName': 'Tajana', 'Affiliation': 'School of Medicine, Zagreb, Croatia.'}, {'ForeName': 'Radic-Kristo', 'Initials': 'RK', 'LastName': 'Delfa', 'Affiliation': 'Department of Hematology, University Hospital Merkur, Zagreb, Croatia.'}, {'ForeName': 'Bilic-Zulle', 'Initials': 'BZ', 'LastName': 'Lidija', 'Affiliation': 'Clinical Institute for Laboratory Diagnostics, Clinical Hospital Centre, Rijeka and Department of Medical Informatics, Rijeka University School of Medicine, Rijeka, Croatia.'}, {'ForeName': 'Orlic', 'Initials': 'O', 'LastName': 'Lidija', 'Affiliation': 'School of Medicine, Rijeka, Croatia.'}, {'ForeName': 'Dinjar-Kujundzic', 'Initials': 'DK', 'LastName': 'Petra', 'Affiliation': 'Department of Gastroenterology, University Hospital Merkur, Zagreb, Croatia.'}, {'ForeName': 'Poropat', 'Initials': 'P', 'LastName': 'Goran', 'Affiliation': 'Department of Gastroenterology, University Hospital Center Rijeka, Rijeka, Croatia.'}, {'ForeName': 'Stimac', 'Initials': 'S', 'LastName': 'Davor', 'Affiliation': 'Department of Gastroenterology, University Hospital Center Rijeka, Rijeka, Croatia.'}, {'ForeName': 'Hauser', 'Initials': 'H', 'LastName': 'Goran', 'Affiliation': 'Department of Gastroenterology, University Hospital Center Rijeka, Rijeka, Croatia.'}, {'ForeName': 'Mikolasevic', 'Initials': 'M', 'LastName': 'Ivana', 'Affiliation': 'Department of Gastroenterology, University Hospital Center Rijeka, Rijeka, Croatia.'}]","Diabetes, obesity & metabolism",['10.1111/dom.14129'] 2711,32613871,"The comparison between pulmonary rehabilitation with music therapy and pulmonary rehabilitation alone on respiratory drive, cortisol level and asthma control in patients hospitalized with asthma exacerbation.","INTRODUCTION Much emphasis is being placed on the role of music therapy as an easy-to-use, non-invasive and relatively cheap method of asthma treatment. The objective of this interventional double-blinded randomised controlled trial was to assess whether music therapy, as a complementary modality to pulmonary rehabilitation, can help to improve respiratory drive, asthma control and quality of life in patients with asthma exacerbation. METHODS Hospitalized patients with asthma exacerbation enrolled in the study were randomly assigned to experimental (music therapy) or control (popular science programme) group. Both groups during hospitalization received standard pharmacotherapy accompanied by respiratory physiotherapy. Respiratory drive, asthma control, quality of life and serum cortisol in all participants were assessed at the beginning and at the end of their hospitalizations. RESULTS The experimental group consisted of 39 asthmatics and 34 subjects with asthma were assigned to the control group. During the hospitalisation, the levels of the inspiratory occlusion pressure for the first 0.1 second of inspiration (P0.1) decreased (p = 0.004) and the maximum P0.1 increased (p = 0.041) only in the experimental group. The serum cortisol level decreased in both groups (p = 0.001). The changes in asthma control and quality of life did not reach significant levels in either subject group. CONCLUSION Passive music therapy and its effects on the mental state of patients seem to improve the efficiency of the respiratory system. The results of this experimental study demonstrate that a complementary music therapy has beneficial effects on the treatment of asthma exacerbations in adults.",2020,The serum cortisol level decreased in both groups (p = 0.001).,"['Hospitalized patients with asthma exacerbation enrolled in the study', 'patients with asthma exacerbation', 'patients hospitalized with asthma exacerbation', '39 asthmatics and 34 subjects with asthma', 'asthma exacerbations in adults']","['standard pharmacotherapy accompanied by respiratory physiotherapy', 'music therapy and pulmonary rehabilitation alone', 'complementary music therapy', 'experimental (music therapy) or control (popular science programme', 'music therapy', 'Passive music therapy']","['levels of the inspiratory occlusion pressure', 'serum cortisol level', 'Respiratory drive, asthma control, quality of life and serum cortisol', 'asthma control and quality of life', 'respiratory drive, asthma control and quality of life', 'respiratory drive, cortisol level and asthma control', 'maximum P0.1']","[{'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0349790', 'cui_str': 'Exacerbation of asthma'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0199467', 'cui_str': 'Physiotherapy of chest'}, {'cui': 'C0026868', 'cui_str': 'Music therapy'}, {'cui': 'C0199529', 'cui_str': 'Pulmonary rehabilitation'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0036397', 'cui_str': 'Science'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0001168', 'cui_str': 'Complete obstruction'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0236396', 'cui_str': 'Serum cortisol measurement'}, {'cui': 'C0004379', 'cui_str': 'Driving'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C4517420', 'cui_str': '0.1'}, {'cui': 'C0205436', 'cui_str': 'Second'}]",39.0,0.0273043,The serum cortisol level decreased in both groups (p = 0.001).,"[{'ForeName': 'Agnieszka', 'Initials': 'A', 'LastName': 'Śliwka', 'Affiliation': 'Unit of Rehabilitation in Internal Diseases, Institute of Physiotherapy, Faculty of Health Sciences, Jagiellonian University Medical College, Kraków, Poland.'}, {'ForeName': 'Marek', 'Initials': 'M', 'LastName': 'Kaszuba', 'Affiliation': 'Unit of Rehabilitation in Internal Diseases, Institute of Physiotherapy, Faculty of Health Sciences, Jagiellonian University Medical College, Kraków, Poland.'}, {'ForeName': 'Rafal', 'Initials': 'R', 'LastName': 'Piliński', 'Affiliation': 'Unit of Rehabilitation in Internal Diseases, Institute of Physiotherapy, Faculty of Health Sciences, Jagiellonian University Medical College, Kraków, Poland.'}, {'ForeName': 'Magdalena', 'Initials': 'M', 'LastName': 'Pieniążek', 'Affiliation': 'Unit of Rehabilitation in Internal Diseases, Department of Clinical Rehabilitation, University School of Physical Education, Kraków, Poland.'}, {'ForeName': 'Magdalena', 'Initials': 'M', 'LastName': 'Batkiewicz', 'Affiliation': 'Doctoral School in Medical and Health Sciences, Jagiellonian University Medical College, Kraków, Poland.'}, {'ForeName': 'Karolina', 'Initials': 'K', 'LastName': 'Marciniak', 'Affiliation': 'Jagiellonian University Hospital, Kraków, Poland.'}, {'ForeName': 'Grażyna', 'Initials': 'G', 'LastName': 'Bochenek', 'Affiliation': 'University Department of Internal Medicine, Faculty of Medicine, Jagiellonian University Medical College, Kraków, Poland.'}, {'ForeName': 'Roman', 'Initials': 'R', 'LastName': 'Nowobilski', 'Affiliation': 'Unit of Rehabilitation in Internal Diseases, Institute of Physiotherapy, Faculty of Health Sciences, Jagiellonian University Medical College, Kraków, Poland.'}]",The Journal of asthma : official journal of the Association for the Care of Asthma,['10.1080/02770903.2020.1789874'] 2712,32613919,A national effectiveness trial of an eHealth program to prevent alcohol and cannabis misuse: responding to the replication crisis.,"BACKGROUND The burden of disease attributable to alcohol and other drug (AOD) use in young people is considerable. Prevention can be effective, yet few programs have demonstrated replicable effects. This study aimed to replicate research behind Climate Schools: Alcohol and Cannabis course among a large cohort of adolescents. METHODS Seventy-one secondary schools across three States participated in a cluster-randomised controlled trial. Year 8 students received either the web-based Climate Schools: Alcohol and Cannabis course (Climate, n = 3236), or health education as usual (Control, n = 3150). Outcomes were measured via self-report and reported here for baseline, 6- and 12-months for alcohol and cannabis knowledge, alcohol, cannabis use and alcohol-related harms. RESULTS Compared to Controls, students in the Climate group showed greater increases in alcohol- [standardised mean difference (SMD) 0.51, p < 0.001] and cannabis-related knowledge (SMD 0.49, p < 0.001), less increases in the odds of drinking a full standard drink[(odds ratio (OR) 0.62, p = 0.014], and heavy episodic drinking (OR 0.49, p = 0.022). There was no evidence for differences in change over time in the odds of cannabis use (OR 0.57, p = 0.22) or alcohol harms (OR 0.73, p = 0.17). CONCLUSIONS The current study provides support for the effectiveness of the web-based Climate Schools: Alcohol and Cannabis course in increasing knowledge and reducing the uptake of alcohol. It represents one of the first trials of a web-based AOD prevention program to replicate alcohol effects in a large and diverse sample of students. Future research and/or adaptation of the program may be warranted with respect to prevention of cannabis use and alcohol harms.",2020,"Compared to Controls, students in the Climate group showed greater increases in alcohol- [standardised mean difference (SMD) 0.51, p < 0.001] and cannabis-related knowledge (SMD 0.49, p < 0.001), less increases in the odds of drinking a full standard drink[(odds ratio (OR) 0.62, p = 0.014], and heavy episodic drinking (OR 0.49, p = 0.022).","['young people', 'Seventy-one secondary schools across three States participated in a cluster-randomised controlled trial']","['web-based Climate Schools: Alcohol and Cannabis course (Climate, n = 3236), or health education', 'eHealth program']","['odds of drinking a full standard drink[(odds ratio', 'heavy episodic drinking', 'alcohol', 'alcohol and cannabis knowledge, alcohol, cannabis use and alcohol-related harms']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0450389', 'cui_str': '71'}, {'cui': 'C0036530', 'cui_str': 'Secondary school'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0008946', 'cui_str': 'Climate'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0024808', 'cui_str': 'Marihuana'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C1328956', 'cui_str': 'eHealth'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0439539', 'cui_str': 'Heavy (weight)'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0024808', 'cui_str': 'Marihuana'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C3160814', 'cui_str': 'Cannabis use'}]",3236.0,0.0473056,"Compared to Controls, students in the Climate group showed greater increases in alcohol- [standardised mean difference (SMD) 0.51, p < 0.001] and cannabis-related knowledge (SMD 0.49, p < 0.001), less increases in the odds of drinking a full standard drink[(odds ratio (OR) 0.62, p = 0.014], and heavy episodic drinking (OR 0.49, p = 0.022).","[{'ForeName': 'Nicola C', 'Initials': 'NC', 'LastName': 'Newton', 'Affiliation': 'The Matilda Centre for Research in Mental Health and Substance Use, The University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Cath', 'Initials': 'C', 'LastName': 'Chapman', 'Affiliation': 'The Matilda Centre for Research in Mental Health and Substance Use, The University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Slade', 'Affiliation': 'The Matilda Centre for Research in Mental Health and Substance Use, The University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Birrell', 'Affiliation': 'The Matilda Centre for Research in Mental Health and Substance Use, The University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Annalise', 'Initials': 'A', 'LastName': 'Healy', 'Affiliation': 'The Matilda Centre for Research in Mental Health and Substance Use, The University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Marius', 'Initials': 'M', 'LastName': 'Mather', 'Affiliation': 'The Matilda Centre for Research in Mental Health and Substance Use, The University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Nyanda', 'Initials': 'N', 'LastName': 'McBride', 'Affiliation': 'National Drug Research Institute, Curtin University, Perth, WA, Australia.'}, {'ForeName': 'Leanne', 'Initials': 'L', 'LastName': 'Hides', 'Affiliation': 'Centre for Youth Substance Abuse Research, University of Queensland, Brisbane, Australia.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Allsop', 'Affiliation': 'National Drug Research Institute, Curtin University, Perth, WA, Australia.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Mewton', 'Affiliation': 'Centre for Healthy Brain Ageing, The University of NSW, Sydney, Australia.'}, {'ForeName': 'Gavin', 'Initials': 'G', 'LastName': 'Andrews', 'Affiliation': 'The Clinical Research Unit for Anxiety and Depression, The University of NSW, Sydney, Australia.'}, {'ForeName': 'Maree', 'Initials': 'M', 'LastName': 'Teesson', 'Affiliation': 'The Matilda Centre for Research in Mental Health and Substance Use, The University of Sydney, Sydney, NSW, Australia.'}]",Psychological medicine,['10.1017/S0033291720001919'] 2713,32615576,A Combination of Hemodialysis with Hemoperfusion Helped to Reduce the Cardiovascular-Related Mortality Rate after a 3-Year Follow-Up: A Pilot Study in Vietnam.,"AIMS Moderate to severe hyperparathyroidism (parathyroid hormone [PTH] concentrations ≥600 pg/mL) may increase the risk of cardiovascular problems and bone disease. We assume that a combination of hemodialysis with hemoperfusion may reduce the cardiovascular-related mortality rate in maintenance hemodialysis. SUBJECTS AND METHODS From 625 maintenance hemodialysis patients, 93 people met with our inclusion criteria. Based on the level of serum PTH, the patients were divided into 2 groups: 46 patients who underwent a combination of hemodialysis and hemoperfusion (HD + HP group) for consecutive 3 years and 47 patients who used hemodialysis only (HD group). RESULTS During 3 years of follow-up, the ratio of mortality was 4.3% in the HD + HP group which was significantly lower than in the HD group (17%), p = 0.049. Based on Kaplan-Meier analysis of cardiovascular-related mortality, patients in the HD group (red line) exhibited a significantly higher death rate compared to the HD + HP group (violet line) (log-rank test, p = 0.049). CONCLUSION We demonstrated that a combination of hemodialysis and hemoperfusion for 3 years helped to reduce the cardiovascular-related mortality rate.",2020,"During 3 years of follow-up, the ratio of mortality was 4.3% in the HD + HP group which was significantly lower than in the HD group (17%), p = 0.049.","['46 patients who underwent a', 'Vietnam', 'group) for consecutive 3 years and 47 patients who used hemodialysis only (HD group', 'From 625 maintenance hemodialysis patients', '93 people met with our inclusion criteria']","['hemodialysis and hemoperfusion', 'HD + HP', 'combination of hemodialysis and hemoperfusion (HD + HP', 'Hemodialysis with Hemoperfusion']","['ratio of mortality', 'Cardiovascular-Related Mortality Rate', 'death rate', 'cardiovascular-related mortality rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0042658', 'cui_str': 'Vietnam'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C4517838', 'cui_str': '625'}, {'cui': 'C4040576', 'cui_str': 'Maintenance hemodialysis'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0019063', 'cui_str': 'Hemoperfusion'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}]",625.0,0.021398,"During 3 years of follow-up, the ratio of mortality was 4.3% in the HD + HP group which was significantly lower than in the HD group (17%), p = 0.049.","[{'ForeName': 'Dung', 'Initials': 'D', 'LastName': 'Nguyen Huu', 'Affiliation': 'Bach Mai Hospital, Ha Noi, Vietnam.'}, {'ForeName': 'Quyen', 'Initials': 'Q', 'LastName': 'Dao Bui Quy', 'Affiliation': 'Cho Ray Hospital, Ho Chi Minh, Vietnam.'}, {'ForeName': 'Hai', 'Initials': 'H', 'LastName': 'Nguyen Thi Thu', 'Affiliation': 'Bach Mai Hospital, Ha Noi, Vietnam.'}, {'ForeName': 'Cuong', 'Initials': 'C', 'LastName': 'Phan The', 'Affiliation': 'Bach Mai Hospital, Ha Noi, Vietnam.'}, {'ForeName': 'Quyen', 'Initials': 'Q', 'LastName': 'Nguyen Thi Hong', 'Affiliation': 'Military Hospital 5, Military Zone 3, Ninh Binh Province, Vietnam.'}, {'ForeName': 'Loc', 'Initials': 'L', 'LastName': 'Nguyen Duc', 'Affiliation': 'An Sinh Hospital, Ho Chi Minh, Vietnam.'}, {'ForeName': 'Quyet', 'Initials': 'Q', 'LastName': 'Do', 'Affiliation': 'Vietnam Military Medical University, Ha Noi, Vietnam.'}, {'ForeName': 'Thang', 'Initials': 'T', 'LastName': 'Le Viet', 'Affiliation': 'Vietnam Military Medical University, Ha Noi, Vietnam, lethangviet@yahoo.co.uk.'}]",Blood purification,['10.1159/000507912'] 2714,32615579,Developmental effects on sleep-wake patterns in infants receiving a cow's milk-based infant formula with an added prebiotic blend: a Randomized Controlled Trial.,"BACKGROUND Few studies have evaluated nutritive effects of prebiotics on infant behavior state, physiology, or metabolic status. METHODS In this double-blind randomized study, infants (n = 161) received cow's milk-based infant formula (Control) or similar formula with an added prebiotic blend (polydextrose and galactooligosaccharides [PDX/GOS]) from 14-35 to 112 days of age. Infant wake behavior (crying/fussing, awake/content) and 24-h sleep-wake actograms were analyzed (Baseline, Days 70 and 112). Salivary cortisol was immunoassayed (Days 70 and 112). In a subset, exploratory stool 16S ribosomal RNA-sequencing was analyzed (Baseline, Day 112). RESULTS One hundred and thirty-one infants completed the study. Average duration of crying/fussing episodes was similar at Baseline, significantly shorter for PDX/GOS vs. Control at Day 70, and the trajectory continued at Day 112. Latency to first and second nap was significantly longer for PDX/GOS vs. Control at Day 112. Cortisol awakening response was demonstrated at Days 70 and 112. Significant stool microbiome beta-diversity and individual taxa abundance differences were observed in the PDX/GOS group. CONCLUSIONS Results indicate faster consolidation of daytime waking state in infants receiving prebiotics and support home-based actigraphy to assess early sleep-wake patterns. A prebiotic effect on wake organization is consistent with influence on the gut-brain axis and warrants further investigation. IMPACT Few studies have evaluated nutritive effects of prebiotics on infant behavior state, cortisol awakening response, sleep-wake entrainment, and gut microbiome.Faster consolidation of daytime waking state was demonstrated in infants receiving a prebiotic blend in infant formula through ~4 months of age.Shorter episodes of crying were demonstrated at ~2 months of age (time point corresponding to age/developmental range associated with peak crying) in infants receiving formula with added prebiotics.Results support home-based actigraphy as a suitable method to assess early sleep-wake patterns.Prebiotic effect on wake organization is consistent with influence on the gut-brain axis and warrants further investigation.",2020,Latency to first and second nap was significantly longer for PDX/GOS vs. Control at Day 112.,"[""infants receiving a cow's milk-based infant formula with an added prebiotic blend"", 'One hundred and thirty-one infants completed the study', 'infants (n\u2009=\u2009161) received']","[""cow's milk-based infant formula (Control) or similar formula with an added prebiotic blend (polydextrose and galactooligosaccharides [PDX/GOS""]","['Latency to first and second nap', 'Average duration of crying/fussing episodes', 'Cortisol awakening response', 'Infant wake behavior (crying/fussing, awake/content) and 24-h sleep-wake actograms', 'sleep-wake patterns', 'Shorter episodes of crying', 'Salivary cortisol', 'Significant stool microbiome beta-diversity and individual taxa abundance differences', 'daytime waking state']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0349374', 'cui_str': ""Cow's milk""}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0150589', 'cui_str': 'Infant formula'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C2717875', 'cui_str': 'Prebiotics'}, {'cui': 'C4319552', 'cui_str': '130'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0349374', 'cui_str': ""Cow's milk""}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0150589', 'cui_str': 'Infant formula'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}, {'cui': 'C2717875', 'cui_str': 'Prebiotics'}, {'cui': 'C0071545', 'cui_str': 'polydextrose'}, {'cui': 'C0332134', 'cui_str': 'Preliminary diagnosis'}]","[{'cui': 'C0242465', 'cui_str': 'Response Latency'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0067518', 'cui_str': 'N-(4-aminophenethyl)spiroperidol'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0010399', 'cui_str': 'Crying'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0020268', 'cui_str': 'Hydrocortisone'}, {'cui': 'C1720052', 'cui_str': 'Awakening'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0442696', 'cui_str': 'Waking'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0234422', 'cui_str': 'Awake'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0449774', 'cui_str': 'Patterns'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0442040', 'cui_str': 'Salivary'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C1956108', 'cui_str': 'Microbiome'}, {'cui': 'C0330390', 'cui_str': 'Beta'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C1301808', 'cui_str': 'State'}]",,0.101785,Latency to first and second nap was significantly longer for PDX/GOS vs. Control at Day 112.,"[{'ForeName': 'John', 'Initials': 'J', 'LastName': 'Colombo', 'Affiliation': 'Schiefelbusch Institute for Life Span Studies and Department of Psychology, University of Kansas, Lawrence, KS, USA. colombo@ku.edu.'}, {'ForeName': 'Susan E', 'Initials': 'SE', 'LastName': 'Carlson', 'Affiliation': 'Department of Dietetics and Nutrition, University of Kansas Medical Center, Kansas City, KS, USA.'}, {'ForeName': 'Cecilia', 'Initials': 'C', 'LastName': 'Algarin', 'Affiliation': 'Sleep and Functional Neurobiology Laboratory, Institute of Nutrition and Food Technology (INTA), University of Chile, Santiago, Chile.'}, {'ForeName': 'Sussanne', 'Initials': 'S', 'LastName': 'Reyes', 'Affiliation': 'Sleep and Functional Neurobiology Laboratory, Institute of Nutrition and Food Technology (INTA), University of Chile, Santiago, Chile.'}, {'ForeName': 'Maciej', 'Initials': 'M', 'LastName': 'Chichlowski', 'Affiliation': 'Nutrition Science, Department of Medical Affairs, Mead Johnson Nutrition, 2400 West Lloyd Expy, Evansville, IN, 47721, USA.'}, {'ForeName': 'Cheryl L', 'Initials': 'CL', 'LastName': 'Harris', 'Affiliation': 'Clinical Research, Department of Medical Affairs, Mead Johnson Nutrition, 2400 West Lloyd Expy, Evansville, IN, 47721, USA.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Wampler', 'Affiliation': 'Clinical Research, Department of Medical Affairs, Mead Johnson Nutrition, 2400 West Lloyd Expy, Evansville, IN, 47721, USA.'}, {'ForeName': 'Patricio', 'Initials': 'P', 'LastName': 'Peirano', 'Affiliation': 'Sleep and Functional Neurobiology Laboratory, Institute of Nutrition and Food Technology (INTA), University of Chile, Santiago, Chile.'}, {'ForeName': 'Carol Lynn', 'Initials': 'CL', 'LastName': 'Berseth', 'Affiliation': 'Clinical Research, Department of Medical Affairs, Mead Johnson Nutrition, 2400 West Lloyd Expy, Evansville, IN, 47721, USA.'}]",Pediatric research,['10.1038/s41390-020-1044-x'] 2715,32615613,"A Prospective, Randomized Trial Testing Different Regimens of Carbohydrate Administration to Prevent Major Reduction in Plasma Glucose Follwing a Standardized Bout of Moderate Physical Activity in Patients with Type 1 Diabetes.","AIM/HYPOTHESIS It was the aim to prospectively study regimes of ""preventive"" carbohydrate administration to avoid major reduction in plasma glucose during physical activity. METHODS 24 patients with type 1 diabetes (age 41±12 years; 11 women, 13 men; BMI 26.5±4.7 kg/m 2 ; HbA 1c 9.1±1.5%; insulin dose 0.64±0.22 IU/kg body weight and day) participated in one experiment without physical activity and in three experiments with a 4 km, 60 min hike starting at 2 p.m.. No ""preventive"" carbohydrates, 2×10 g or 2×20 g carbohydrates (muesli bars) were taken when starting and after 30 min (randomized order). Plasma glucose was determined. RESULTS Within 30 min after starting physical activity, plasma glucose fell by approximately 70 mg/dl, making additional carbohydrate intake necessary in 70% of the subjects. This drop was not prevented by any regimens of ""preventive"" carbohydrate intake. After the nadir, plasma glucose rose faster after the 2×20 g carbohydrate regime (the largest amount tested; p=0.0036). With ""preventive"" administration of carbohydrates, significantly (p<0.05) less additional ""therapeutic"" carbohydrates needed to be administered in 6 h following the initiation of the hike. CONCLUSIONS/INTERPRETATION In conclusion, in the setting of 2 h postprandial exercise in type 1 diabetes, preventive carbohydrate supplementation alone will not completely eliminate the risk of brisk falls in plasma glucose concentrations or hypoglycaemic episodes. Else, higher amounts or repeated administration of carbohydrates may be necessary.",2020,"With ""preventive"" administration of carbohydrates, significantly (p<0.05) less additional ""therapeutic"" carbohydrates needed to be administered in 6 h following the initiation of the hike. ","['Patients with Type 1 Diabetes', '24 patients with type 1 diabetes (age 41±12 years; 11 women, 13 men; BMI 26.5±4.7 kg/m 2 ; HbA 1c 9.1±1.5%; insulin dose 0.64±0.22 IU/kg body weight and day) participated in']","['Carbohydrate Administration', 'one experiment without physical activity']","['plasma glucose fell', 'Plasma glucose', 'nadir, plasma glucose', 'Plasma Glucose']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0560608', 'cui_str': 'IU/kg body weight'}, {'cui': 'C0332173', 'cui_str': 'Daily'}]","[{'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}]",24.0,0.0263164,"With ""preventive"" administration of carbohydrates, significantly (p<0.05) less additional ""therapeutic"" carbohydrates needed to be administered in 6 h following the initiation of the hike. ","[{'ForeName': 'Hanna', 'Initials': 'H', 'LastName': 'Frenzke', 'Affiliation': 'Diabeteszentrum Bad Lauterberg im Harz, Germany (where work was performed).'}, {'ForeName': 'Annette', 'Initials': 'A', 'LastName': 'Varnhorn', 'Affiliation': 'Diabeteszentrum Bad Lauterberg im Harz, Germany (where work was performed).'}, {'ForeName': 'Heike', 'Initials': 'H', 'LastName': 'Schulze', 'Affiliation': 'Diabeteszentrum Bad Lauterberg im Harz, Germany (where work was performed).'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Kahle-Stephan', 'Affiliation': 'Diabeteszentrum Bad Lauterberg im Harz, Germany (where work was performed).'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Nauck', 'Affiliation': 'Diabeteszentrum Bad Lauterberg im Harz, Germany (where work was performed).'}]","Experimental and clinical endocrinology & diabetes : official journal, German Society of Endocrinology [and] German Diabetes Association",['10.1055/a-1190-3614'] 2716,32615614,A Comparison of Central Anatomic Single-Bundle Reconstruction and Anatomic Double-Bundle Reconstruction in Anteroposterior and Rotational Knee Stability: Intraoperative Biomechanical Evaluation.,"Postoperative anterior and rotational stability are still controversial when compared with single-bundle (SB) and double-bundle (DB) anterior cruciate ligament (ACL) reconstruction. This study aimed to compare the central anatomical SB and anatomical DB ACL reconstruction in intraoperative knee kinematics during continuous knee flexion-extension. A total of 34 patients who underwent ACL reconstruction using the hamstring tendon were evaluated intraoperatively before and immediately after ACL reconstruction using OrthoPilot ACL Navigation System Version 3.0. The patients were prospectively randomized into the central anatomical SB (17 knees) and the anatomical DB reconstruction (17 knees) groups. The tibial translation and rotation were continuously measured during knee flexion-extension under conventional knee motion, anterior tibial load (100N), and internal-external torque (3 N·m). The anterior tibial translation and total range of tibial rotation were calculated from the measurement values from 20 to 50 degrees at each 5-degree point. The anterior tibial translation ( p  = 0.59; two-factor repeated measures analysis of variance; η 2 G = 0.0077) and total range of tibial rotation ( p  = 0.95; η 2 G = 0.0001) at each knee flexion angle showed no significant difference between the central anatomical SB and anatomical DB reconstruction groups. It is suggested that the central anatomical SB reconstruction is comparable with the anatomical DB reconstruction in biomechanical anteroposterior and rotational knee stability at time 0.",2020,The anterior tibial translation ( p  = 0.59; two-factor repeated measures analysis of variance; η 2 G = 0.0077) and total range of tibial rotation ( p  = 0.95; η 2 G = 0.0001) at each knee flexion angle showed no significant difference between the central anatomical SB and anatomical DB reconstruction groups.,"['34 patients who underwent', 'continuous knee flexion-extension']","['central anatomical SB', 'ACL reconstruction using the hamstring tendon were evaluated intraoperatively before and immediately after ACL reconstruction using OrthoPilot ACL Navigation System Version 3.0', 'central anatomical SB and anatomical DB ACL reconstruction', 'single-bundle (SB) and double-bundle (DB) anterior cruciate ligament (ACL) reconstruction', 'Central Anatomic Single-Bundle Reconstruction and Anatomic Double-Bundle Reconstruction', 'anatomical DB reconstruction']","['anterior tibial translation and total range of tibial rotation', 'Postoperative anterior and rotational stability', 'total range of tibial rotation', 'tibial translation and rotation', 'anterior tibial translation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0444509', 'cui_str': 'Flexion/extension'}]","[{'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0220784', 'cui_str': 'Anatomic'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C3178820', 'cui_str': 'Anterior Cruciate Ligament Reconstruction'}, {'cui': 'C1267157', 'cui_str': 'Hamstring Tendons'}, {'cui': 'C0205548', 'cui_str': 'Stat'}, {'cui': 'C0078960', 'cui_str': 'Structure of anterior cruciate ligament of knee joint'}, {'cui': 'C4075648', 'cui_str': 'Navigation system'}, {'cui': 'C2607870', 'cui_str': 'Version'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}]","[{'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0040184', 'cui_str': 'Bone structure of tibia'}, {'cui': 'C0040712', 'cui_str': 'Translations'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0035868', 'cui_str': 'Rotation'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0445237', 'cui_str': 'Rotational'}, {'cui': 'C0205360', 'cui_str': 'Stable'}]",34.0,0.0185207,The anterior tibial translation ( p  = 0.59; two-factor repeated measures analysis of variance; η 2 G = 0.0077) and total range of tibial rotation ( p  = 0.95; η 2 G = 0.0001) at each knee flexion angle showed no significant difference between the central anatomical SB and anatomical DB reconstruction groups.,"[{'ForeName': 'Yasunari', 'Initials': 'Y', 'LastName': 'Ikuta', 'Affiliation': 'Department of Orthopaedic Surgery, Hiroshima University Graduate School of Biomedical and Health Sciences, Hiroshima, Japan.'}, {'ForeName': 'Atsuo', 'Initials': 'A', 'LastName': 'Nakamae', 'Affiliation': 'Department of Orthopaedic Surgery, Hiroshima University Graduate School of Biomedical and Health Sciences, Hiroshima, Japan.'}, {'ForeName': 'Ryo', 'Initials': 'R', 'LastName': 'Shimizu', 'Affiliation': 'Department of Orthopaedic Surgery, Hiroshima University Graduate School of Biomedical and Health Sciences, Hiroshima, Japan.'}, {'ForeName': 'Masakazu', 'Initials': 'M', 'LastName': 'Ishikawa', 'Affiliation': 'Department of Orthopaedic Surgery, Hiroshima University Graduate School of Biomedical and Health Sciences, Hiroshima, Japan.'}, {'ForeName': 'Tomoyuki', 'Initials': 'T', 'LastName': 'Nakasa', 'Affiliation': 'Department of Orthopaedic Surgery, Hiroshima University Graduate School of Biomedical and Health Sciences, Hiroshima, Japan.'}, {'ForeName': 'Mitsuo', 'Initials': 'M', 'LastName': 'Ochi', 'Affiliation': 'President of Hiroshima University, Japan.'}, {'ForeName': 'Nobuo', 'Initials': 'N', 'LastName': 'Adachi', 'Affiliation': 'Department of Orthopaedic Surgery, Hiroshima University Graduate School of Biomedical and Health Sciences, Hiroshima, Japan.'}]",The journal of knee surgery,['10.1055/s-0040-1713730'] 2717,32615679,"Efficacy and Safety of Naftopidil in Patients With Neurogenic Lower Urinary Tract Dysfunction: An 8-Week, Active-Controlled, Stratified-Randomized, Double-Blind, Double-Dummy, Parallel Group, Noninferiority, Multicenter Design.","PURPOSE The aim of this study was to evaluate the efficacy and safety of naftopidil compared with tamsulosin in patients with neurogenic lower urinary tract dysfunction (LUTD). METHODS This study was conducted as an 8-week, active-controlled, stratified-randomized, double-blind, double-dummy, parallel group, noninferiority, and multicenter clinical trial. After 2 weeks of screening, eligible subjects were randomly assigned to receive naftopidil (25 mg for 1 week followed by 75 mg for 7 weeks) or tamsulosin (0.2 mg for 8 weeks). Primary endpoint was a change of International Prostatic Symptom Score (IPSS) total score after 8 weeks of treatment. RESULTS One hundred ninety-four subjects with neurogenic LUTD were included into this trial. There were no differences between the 2 groups in baseline characteristics, including urodynamic study results, subtype of LUTD, pretreatment and concomitant medication, and causes of neurogenic bladder. The medication compliance rate was 94.0% (naftopidil, 93.6%; tamsulosin, 94.4%). There was a statistically significant decrease of IPSS total score at 8 weeks versus baseline in both the naftopidil (-5.64±0.66) and tamsulosin (-6.53±0.65) groups (P<0.0001 each). The mean difference between both groups was 0.89 (upper limit of 95% confidential interval, 2.72), which was lower than the noninferiority limit of 3 points. A subgroup analysis of neurologic lesions and sex found no mean difference of IPSS total score in each group. There was also no difference in safety profiles, including treatment emergent adverse events. CONCLUSION Naftopidil was not inferior to tamsulosin as a therapeutic drug for patients with neurogenic LUTD and had a similar safety profile.",2020,Naftopidil was not inferior to tamsulosin as a therapeutic drug for patients with neurogenic LUTD and had a similar safety profile.,"['patients with neurogenic lower urinary tract dysfunction (LUTD', 'One hundred ninety-four subjects with neurogenic LUTD', 'Patients With Neurogenic Lower Urinary Tract Dysfunction', 'patients with neurogenic LUTD']","['naftopidil', 'Naftopidil', 'tamsulosin']","['Efficacy and Safety', 'urodynamic study results, subtype of LUTD, pretreatment and concomitant medication, and causes of neurogenic bladder', 'IPSS total score', 'safety profiles', 'change of International Prostatic Symptom Score (IPSS) total score', 'efficacy and safety', 'medication compliance rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0729866', 'cui_str': 'Lower urinary tract structure'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C3816959', 'cui_str': '90'}]","[{'cui': 'C0083701', 'cui_str': 'naftopidil'}, {'cui': 'C0257343', 'cui_str': 'tamsulosin'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0042059', 'cui_str': 'Urodynamics'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0449560', 'cui_str': 'Subtype'}, {'cui': 'C0729866', 'cui_str': 'Lower urinary tract structure'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0015127', 'cui_str': 'etiology'}, {'cui': 'C0005697', 'cui_str': 'Neurogenic bladder'}, {'cui': 'C0033572', 'cui_str': 'Prostatic'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}]",194.0,0.49413,Naftopidil was not inferior to tamsulosin as a therapeutic drug for patients with neurogenic LUTD and had a similar safety profile.,"[{'ForeName': 'Hyun Hwan', 'Initials': 'HH', 'LastName': 'Sung', 'Affiliation': 'Department of Urology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.'}, {'ForeName': 'Myung-Soo', 'Initials': 'MS', 'LastName': 'Choo', 'Affiliation': 'Department of Urology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.'}, {'ForeName': 'Joon Chul', 'Initials': 'JC', 'LastName': 'Kim', 'Affiliation': 'Department of Urology, College of Medicine, The Catholic University of Korea, Seoul, Korea.'}, {'ForeName': 'Jang Hwan', 'Initials': 'JH', 'LastName': 'Kim', 'Affiliation': 'Department of Urology, Yonsei University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Kyu-Sung', 'Initials': 'KS', 'LastName': 'Lee', 'Affiliation': 'Department of Urology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.'}]",International neurourology journal,['10.5213/inj.1938198.099'] 2718,32615683,"Commentary on ""Role of Transcutaneous Electrical Nerve Stimulation in Treating Children With Overactive Bladder From Pooled Analysis of 8 Randomized Controlled Trials"".",,2020,,['Treating Children With Overactive Bladder'],['Transcutaneous Electrical Nerve Stimulation'],[],"[{'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0878773', 'cui_str': 'Overactive bladder'}]","[{'cui': 'C0040654', 'cui_str': 'Percutaneous electrical nerve stimulation'}]",[],,0.0990578,,"[{'ForeName': 'Isabel Casal', 'Initials': 'IC', 'LastName': 'Beloy', 'Affiliation': ""Pediatric Urology Division, Pediatric Surgery Department, University Children's Hospital of A Coruña, A Coruña, Spain.""}, {'ForeName': 'Miriam García', 'Initials': 'MG', 'LastName': 'González', 'Affiliation': ""Pediatric Urology Division, Pediatric Surgery Department, University Children's Hospital of A Coruña, A Coruña, Spain.""}, {'ForeName': 'Iván Somoza', 'Initials': 'IS', 'LastName': 'Argibay', 'Affiliation': ""Pediatric Urology Division, Pediatric Surgery Department, University Children's Hospital of A Coruña, A Coruña, Spain.""}]",International neurourology journal,['10.5213/inj.2040164.082'] 2719,32615684,"Reply to Commentary on ""Role of Transcutaneous Electrical Nerve Stimulation in Treating Children With Overactive Bladder From Pooled Analysis of 8 Randomized Controlled Trials"".",,2020,,['Treating Children With Overactive Bladder'],['Transcutaneous Electrical Nerve Stimulation'],[],"[{'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0878773', 'cui_str': 'Overactive bladder'}]","[{'cui': 'C0040654', 'cui_str': 'Percutaneous electrical nerve stimulation'}]",[],,0.0839461,,"[{'ForeName': 'Zhongbao', 'Initials': 'Z', 'LastName': 'Zhou', 'Affiliation': 'Department of Urology, The Affiliated Yantai Yuhuangding Hospital of Qingdao University, Shandong, China.'}, {'ForeName': 'Yuanshan', 'Initials': 'Y', 'LastName': 'Cui', 'Affiliation': 'Department of Urology, The Affiliated Yantai Yuhuangding Hospital of Qingdao University, Shandong, China.'}]",International neurourology journal,['10.5213/inj.2040168.084'] 2720,32615697,Headache Relief Is Maintained 7 Years After Anterior Cervical Spine Surgery: Post Hoc Analysis From a Multicenter Randomized Clinical Trial and Cervicogenic Headache Hypothesis.,"OBJECTIVE To evaluate whether anterior cervical spine surgery offers sustained (7 years) relief in patients with cervicogenic headaches (CGHs), and evaluate the difference between cervical disc arthroplasty (CDA) and anterior cervical discectomy and fusion (ACDF) for 1 and 2-level surgeries from a multicenter randomized clinical trial. METHODS A post hoc analysis was performed of 575 patients who underwent one or 2-level CDA or ACDF for symptomatic cervical spondylosis as part of a prospective randomized clinical trial. Assessment of pain and functional outcome was done with the Neck Disability Index (NDI) in the trial. We used the NDI headache component to assess headache outcome. RESULTS For both 1- and 2-level CDA and ACDF groups, there was significant headache improvement from preoperative baseline out to 7 years (p < 0.0001). For 1-level surgeries, headache improvement was similar for both groups at the 7-year point. For 2-level treatment, CDA patients had significantly improved headache scores versus ACDF patients at the 7-year point (p = 0.016). CONCLUSION The headache improvement noted at early follow-up was sustained over the long-term period with ACDF and CDA populations. In the case of 2-level operations, CDA patients demonstrated significantly greater benefit compared to ACDF patients over the long-term. Sinuvertebral nerve irritation at the unco-vasculo-radicular junction and anterior dura may be the cause of CGH. Therefore, it is possible that improved cervical kinematics and preservation of range of motion at adjacent uncovertebral joints in CDA may contribute to the observed difference between the groups.",2020,The headache improvement noted at early follow-up was sustained over the long-term period with ACDF and CDA populations.,"['575 patients who underwent one or', 'patients with cervicogenic headaches (CGHs']","['2-level CDA or ACDF', 'anterior cervical spine surgery', 'ACDF', 'cervical disc arthroplasty (CDA) and anterior cervical discectomy and fusion (ACDF']","['Neck Disability Index (NDI', 'headache scores', 'Headache Relief', 'headache improvement', 'Sinuvertebral nerve irritation']","[{'cui': 'C3844102', 'cui_str': '575'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0458101', 'cui_str': 'Cervicogenic headache'}]","[{'cui': 'C0456948', 'cui_str': 'Level 2'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0003893', 'cui_str': 'Arthroplasty'}, {'cui': 'C4552416', 'cui_str': 'ACDF'}, {'cui': 'C0442011', 'cui_str': 'Anterior cervical spine approach'}, {'cui': 'C0920347', 'cui_str': 'Procedure on spinal cord'}, {'cui': 'C0206078', 'cui_str': 'Discectomy of spine'}, {'cui': 'C0332466', 'cui_str': 'Fusion'}]","[{'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0564405', 'cui_str': 'Feeling relief'}, {'cui': 'C0228813', 'cui_str': 'Structure of spinal nerve meningeal branch'}, {'cui': 'C0441723', 'cui_str': 'Irritation'}]",575.0,0.0936108,The headache improvement noted at early follow-up was sustained over the long-term period with ACDF and CDA populations.,"[{'ForeName': 'Harjot', 'Initials': 'H', 'LastName': 'Thind', 'Affiliation': 'Department of Neurological Surgery, University of California Davis, Sacramento, CA, USA.'}, {'ForeName': 'Dinesh', 'Initials': 'D', 'LastName': 'Ramanathan', 'Affiliation': 'Department of Neurological Surgery, University of California Davis, Sacramento, CA, USA.'}, {'ForeName': 'Julius', 'Initials': 'J', 'LastName': 'Ebinu', 'Affiliation': 'Department of Neurological Surgery, University of California Davis, Sacramento, CA, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Copenhaver', 'Affiliation': 'Department of Anesthesiology and Pain Medicine, University of California Davis, Sacramento, CA, USA.'}, {'ForeName': 'Kee D', 'Initials': 'KD', 'LastName': 'Kim', 'Affiliation': 'Department of Neurological Surgery, University of California Davis, Sacramento, CA, USA.'}]",Neurospine,['10.14245/ns.2040004.002'] 2721,32615727,"Effect of Lactobacillus sakei, a Probiotic Derived from Kimchi, on Body Fat in Koreans with Obesity: A Randomized Controlled Study.","BACKGROUND The increased prevalence of obesity has led to increases in the prevalence of chronic diseases worldwide. There is interest whether probiotics have an effect on obesity, but the effectiveness and safety of only a few probiotics for the treatment of obesity have been reported. The purpose of this study was to investigate whether ingestion of Lactobacillus sakei (CJLS03) derived from kimchi causes weight loss in people with obesity. METHODS This randomized, double-blind, placebo-controlled, clinical trial involved 114 adults with a body mass index (BMI) ≥25 kg/m2 who were assigned randomly to a CJLS03 or placebo group. The groups received two allocations of either 5×109 colony-forming units of CJLS03/allocation or the equivalent vehicle for 12 weeks. Demographic and biochemical parameters, and body composition including fat and muscle mass were measured at baseline and after 12 weeks. Changes in body fat, weight, and waist circumference were compared between the two treatment groups. Adverse events were monitored during study period. RESULTS Body fat mass decreased by 0.2 kg in the CJLS03 group and increased by 0.6 kg in the placebo group (0.8 kg difference, P=0.018). After the 12 weeks, waist circumference was 0.8 cm smaller in the CJLS03 group than in the placebo group (P=0.013). BMI and body weight did not change after the 12 weeks. Adverse events were mild and did not differ between the two groups. CONCLUSION These data suggest that L. sakei (CJLS03) might help people with obesity reduce body fat mass without serious side effects (ClinicalTrials.gov: NCT03248414).",2020,"After the 12 weeks, waist circumference was 0.8 cm smaller in the CJLS03 group than in the placebo group (P=0.013).","['114 adults with a body mass index (BMI) ≥25 kg/m2 who', 'people with obesity', 'Koreans with Obesity']","['L. sakei (CJLS03', 'Lactobacillus sakei, a Probiotic Derived from Kimchi', 'Lactobacillus sakei (CJLS03', '5×109 colony-forming units of CJLS03/allocation', 'CJLS03', 'CJLS03 or placebo', 'placebo']","['Body fat mass', 'body fat, weight, and waist circumference', 'waist circumference', 'Adverse events', 'BMI and body weight', 'Demographic and biochemical parameters, and body composition including fat and muscle mass']","[{'cui': 'C4708785', 'cui_str': '114'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}]","[{'cui': 'C0317639', 'cui_str': 'Lactobacillus sakei'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0439158', 'cui_str': 'colonies'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0240417', 'cui_str': 'Form of muscle'}]",114.0,0.462224,"After the 12 weeks, waist circumference was 0.8 cm smaller in the CJLS03 group than in the placebo group (P=0.013).","[{'ForeName': 'Soo', 'Initials': 'S', 'LastName': 'Lim', 'Affiliation': 'Department of Internal Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, Korea.'}, {'ForeName': 'Ji Hye', 'Initials': 'JH', 'LastName': 'Moon', 'Affiliation': 'Department of Internal Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, Korea.'}, {'ForeName': 'Chol Min', 'Initials': 'CM', 'LastName': 'Shin', 'Affiliation': 'Department of Internal Medicine, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seongnam, Korea.'}, {'ForeName': 'Dahye', 'Initials': 'D', 'LastName': 'Jeong', 'Affiliation': 'CJ Foods R&D, CJ CheilJedang Corporation, Suwon, Korea.'}, {'ForeName': 'Bongjoon', 'Initials': 'B', 'LastName': 'Kim', 'Affiliation': 'CJ CheilJedang Corporation, Suwon, Korea.'}]","Endocrinology and metabolism (Seoul, Korea)",['10.3803/EnM.2020.35.2.425'] 2722,32615777,Acute differences in blood lipids and inflammatory biomarkers following controlled exposures to cookstove air pollution in the STOVES study.,"Household air pollution is a leading risk factor for morbidity and premature mortality. Numerous cookstoves have been developed to reduce household air pollution, but it is unclear whether such cookstoves meaningfully improve health. In a controlled exposure study with a crossover design, we assessed the effect of pollution emitted from multiple cookstoves on acute differences in blood lipids and inflammatory biomarkers. Participants (n = 48) were assigned to treatment sequences of exposure to air pollution emitted from five cookstoves and a filtered-air control. Blood lipids and inflammatory biomarkers were measured before and 0, 3, and 24 hours after treatments. Many of the measured outcomes had inconsistent results. However, compared to control, intercellular adhesion molecule-1 was higher 3 hours after all treatments, and C-reactive protein and serum amyloid-A were higher 24 hours after the highest treatment. Our results suggest that short-term exposure to cookstove air pollution can increase inflammatory biomarkers within 24 hours.",2020,"However, compared to control, intercellular adhesion molecule-1 was higher 3 hours after all treatments, and C-reactive protein and serum amyloid-A were higher 24 hours after the highest treatment.",['Participants (n\xa0=\xa048'],['exposure to air pollution emitted from five cookstoves and a filtered-air control'],"['blood lipids and inflammatory biomarkers', 'inflammatory biomarkers', 'C-reactive protein and serum amyloid-A', 'Blood lipids and inflammatory biomarkers', 'intercellular adhesion molecule-1']",[],"[{'cui': 'C0476602', 'cui_str': 'Exposure to air pollution'}, {'cui': 'C0162676', 'cui_str': 'Enzyme-multiplied immunoassay technique'}, {'cui': 'C0180860', 'cui_str': 'Filter'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0002723', 'cui_str': 'Serum amyloid A protein'}, {'cui': 'C0063695', 'cui_str': 'Lymphocyte antigen CD54'}]",48.0,0.0426891,"However, compared to control, intercellular adhesion molecule-1 was higher 3 hours after all treatments, and C-reactive protein and serum amyloid-A were higher 24 hours after the highest treatment.","[{'ForeName': 'Ethan S', 'Initials': 'ES', 'LastName': 'Walker', 'Affiliation': 'Department of Environmental and Radiological Health Sciences, Colorado State University , Fort Collins, CO, USA.'}, {'ForeName': 'Kristen M', 'Initials': 'KM', 'LastName': 'Fedak', 'Affiliation': 'Department of Environmental and Radiological Health Sciences, Colorado State University , Fort Collins, CO, USA.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Good', 'Affiliation': 'Department of Environmental and Radiological Health Sciences, Colorado State University , Fort Collins, CO, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Balmes', 'Affiliation': 'Department of Medicine, University of California San Francisco , San Francisco, CA, USA.'}, {'ForeName': 'Robert D', 'Initials': 'RD', 'LastName': 'Brook', 'Affiliation': 'Division of Cardiovascular Medicine, University of Michigan Medical School , Ann Arbor, MI, USA.'}, {'ForeName': 'Maggie L', 'Initials': 'ML', 'LastName': 'Clark', 'Affiliation': 'Department of Environmental and Radiological Health Sciences, Colorado State University , Fort Collins, CO, USA.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Cole-Hunter', 'Affiliation': 'Department of Environmental and Radiological Health Sciences, Colorado State University , Fort Collins, CO, USA.'}, {'ForeName': 'Robert B', 'Initials': 'RB', 'LastName': 'Devlin', 'Affiliation': 'Environmental Public Health Division, United States Environmental Protection Agency, Research Triangle Park , NC, USA.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': ""L'Orange"", 'Affiliation': 'Department of Mechanical Engineering, Colorado State University , Fort Collins, CO, USA.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Luckasen', 'Affiliation': 'Heart Center of the Rockies , Fort Collins, CO, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Mehaffy', 'Affiliation': 'Department of Mechanical Engineering, Colorado State University , Fort Collins, CO, USA.'}, {'ForeName': 'Rhiannon', 'Initials': 'R', 'LastName': 'Shelton', 'Affiliation': 'Department of Environmental and Radiological Health Sciences, Colorado State University , Fort Collins, CO, USA.'}, {'ForeName': 'Ander', 'Initials': 'A', 'LastName': 'Wilson', 'Affiliation': 'Department of Statistics, Colorado State University , Fort Collins, CO, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Volckens', 'Affiliation': 'Department of Mechanical Engineering, Colorado State University , Fort Collins, CO, USA.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Peel', 'Affiliation': 'Department of Environmental and Radiological Health Sciences, Colorado State University , Fort Collins, CO, USA.'}]",International journal of environmental health research,['10.1080/09603123.2020.1785402'] 2723,32615895,[Promoting Self-Regulation of Adolescents in School Through Mindfulness].,"Promoting Self-Regulation of Adolescents in School Through Mindfulness. Evaluation of the Mindfulness Training ""8-sam"" Mindfulness describes the psychological process of purposely bringing one's attention to the present experiences with an accepting, non-judgmental attitude. As such, it has attracted increasing interest in educational institutions. The present study aims to evaluate a mindfulness training for adolescents in a German high school. For this purpose, the program ""8-sam"" has been developed. Feasibility, acceptance and efficacy of this four-week training were examined in a sample of 48 ninth-grade students. Self-ratings of mindfulness, chronic stress, emotion regulation and health, as well as behavioral measures of attention and mind-wandering of the intervention group (n = 22) were compared to the wait control group (n = 24) before, immediately and 6 weeks after the training. As indicated by self-designed evaluation questionnaires, the training proved to be well accepted and implementable at school. The intervention group showed less mind-wandering after the training than the control group. The findings offer implications for future research and the application of mindfulness trainings in schools. Implementing mindfulness in the daily school routine promises to support self-regulatory processes and thus, strengthen the resilience of children and adolescents.",2020,The intervention group showed less mind-wandering after the training than the control group.,"['schools', 'children and adolescents', 'sample of 48 ninth-grade students', 'adolescents in a German high school']",['mindfulness training'],"['Self-ratings of mindfulness, chronic stress, emotion regulation and health', 'Feasibility, acceptance and efficacy']","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0205443', 'cui_str': 'Ninth'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0017477', 'cui_str': 'German language'}, {'cui': 'C0205250', 'cui_str': 'High'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C2370884', 'cui_str': 'Emotion Self-Regulation'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0237445', 'cui_str': 'Social Acceptance'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}]",22.0,0.0106743,The intervention group showed less mind-wandering after the training than the control group.,"[{'ForeName': 'Marie O', 'Initials': 'MO', 'LastName': 'Frenkel', 'Affiliation': 'Institut für Sport und Sportwissenschaft Universität Heidelberg Im Neuenheimer Feld 720 69120 Heidelberg Deutschland Institut für Sport und Sportwissenschaft.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Georg', 'Affiliation': 'Institut für Psychosoziale Prävention Universität Heidelberg Deutschland Institut für Psychosoziale Prävention.'}, {'ForeName': 'Henning', 'Initials': 'H', 'LastName': 'Plessner', 'Affiliation': 'Institut für Sport und Sportwissenschaft Universität Heidelberg Im Neuenheimer Feld 720 69120 Heidelberg Deutschland Institut für Sport und Sportwissenschaft.'}]",Praxis der Kinderpsychologie und Kinderpsychiatrie,['10.13109/prkk.2020.69.4.321'] 2724,32615951,Crowdsourcing to promote hepatitis C testing and linkage-to-care in China: a randomized controlled trial protocol.,"BACKGROUND Hepatitis C virus (HCV) is a growing public health problem with a large disease burden worldwide. In China many people living with HCV are unaware of their hepatitis status and not connected to care and treatment. Crowdsourcing is a technique that invites the public to create health promotion materials and has been found to increase HIV testing uptake, including in China. This trial aims to evaluate crowdsourcing as a strategy to improve HCV awareness, testing and linkage-to-care in China. METHODS A randomized controlled, two-armed trial (RCT) is being conducted in Shenzhen with 1006 participants recruited from primary care sectors of The University of Hong Kong-Shenzhen Hospital. Eligible participants are ≥30 years old; a resident in Shenzhen for at least one month after recruitment; no screening for HCV within the past 12 months and not known to have chronic HCV; and, having a WeChat social media account. Allocation is 1:1. Both groups will be administered a baseline and a follow-up survey (4-week post-enrollment). The intervention group will receive crowdsourcing materials to promote HCV testing once a week for two weeks and feedback will be collected thereafter, while the control group will receive no promotional materials. Feedback collected will be judged by a panel and selected to be implemented to improve the intervention continuously. Those identified positive for HCV antibodies will be referred to gastroenterologists for confirmation and treatment. The primary outcome will be confirmed HCV testing uptake, and secondary outcomes include HCV confirmatory testing and initiation of HCV treatment with follow-ups with specialist providers. Data will be collected on Survey Star @ via mobile devices. DISCUSSION This will be the first study to evaluate the impact of crowdsourcing to improve viral hepatitis testing and linkage-to-care in the health facilities. This RCT will contribute to the existing literature on interventions to improve viral hepatitis testing in primary care setting, and inform future strategies to improve HCV care training for primary care providers in China. TRIAL REGISTRATION Chinese Clinical Trial Registry. ChiCTR1900025771. Registered September 7th, 2019, http://www.chictr.org.cn/showprojen.aspx?proj=42788.",2020,"Crowdsourcing is a technique that invites the public to create health promotion materials and has been found to increase HIV testing uptake, including in China.","['primary care providers in China', 'China', 'Shenzhen with 1006 participants recruited from primary care sectors of The University of Hong Kong-Shenzhen Hospital', 'Eligible participants are ≥30\u2009years old; a resident in Shenzhen for at least one month after recruitment; no screening for HCV within the past 12\u2009months and not known to have chronic HCV; and, having a WeChat social media account']","['crowdsourcing materials to promote HCV testing', 'control group will receive no promotional materials']","['confirmed HCV testing uptake, and secondary outcomes include HCV confirmatory testing and initiation of HCV treatment with follow-ups with specialist providers']","[{'cui': 'C2735026', 'cui_str': 'Primary care provider'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0019907', 'cui_str': 'Hong Kong'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C4082115', 'cui_str': 'One month'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0079500', 'cui_str': 'Hepacivirus'}, {'cui': 'C1444637', 'cui_str': 'Past'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0439673', 'cui_str': 'Unknown'}, {'cui': 'C0524910', 'cui_str': 'Chronic hepatitis C'}, {'cui': 'C0042769', 'cui_str': 'Viral disease'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C3179065', 'cui_str': 'Social Medium'}]","[{'cui': 'C0520510', 'cui_str': 'Material'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0079500', 'cui_str': 'Hepacivirus'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0079500', 'cui_str': 'Hepacivirus'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0087009', 'cui_str': 'Hospital specialist'}]",1006.0,0.0962497,"Crowdsourcing is a technique that invites the public to create health promotion materials and has been found to increase HIV testing uptake, including in China.","[{'ForeName': 'William C W', 'Initials': 'WCW', 'LastName': 'Wong', 'Affiliation': 'Department of General Practice, HKU-Shenzhen Hospital, Shenzhen, China.'}, {'ForeName': 'Nancy S', 'Initials': 'NS', 'LastName': 'Yang', 'Affiliation': 'University of Minnesota Medical School, Minneapolis, MN, USA.'}, {'ForeName': 'Jingjing', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'University of North Carolina Project-China, 1 Global Health Center Office, 2nd Floor of Lao Gan Building, No. 7 Lujing Road, Yuexiu District, Guangzhou City, Guangdong Province, Guangzhou, China. jingjingli@seshglobal.org.'}, {'ForeName': 'Hang', 'Initials': 'H', 'LastName': 'Li', 'Affiliation': 'Department of General Practice, HKU-Shenzhen Hospital, Shenzhen, China.'}, {'ForeName': 'Eric Y F', 'Initials': 'EYF', 'LastName': 'Wan', 'Affiliation': 'Department of Family Medicine and Primary Care, The University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Fitzpatrick', 'Affiliation': 'University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Yuan', 'Initials': 'Y', 'LastName': 'Xiong', 'Affiliation': 'University of North Carolina Project-China, 1 Global Health Center Office, 2nd Floor of Lao Gan Building, No. 7 Lujing Road, Yuexiu District, Guangzhou City, Guangdong Province, Guangzhou, China.'}, {'ForeName': 'Wai-Kay', 'Initials': 'WK', 'LastName': 'Seto', 'Affiliation': 'Department of Medicine, The University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Polin', 'Initials': 'P', 'LastName': 'Chan', 'Affiliation': 'World Health Organization Western Pacific Regional Office, Manila, Philippines.'}, {'ForeName': 'Ruihong', 'Initials': 'R', 'LastName': 'Liu', 'Affiliation': 'Department of General Practice, HKU-Shenzhen Hospital, Shenzhen, China.'}, {'ForeName': 'Weiming', 'Initials': 'W', 'LastName': 'Tang', 'Affiliation': 'University of North Carolina Project-China, 1 Global Health Center Office, 2nd Floor of Lao Gan Building, No. 7 Lujing Road, Yuexiu District, Guangzhou City, Guangdong Province, Guangzhou, China.'}, {'ForeName': 'Joseph D', 'Initials': 'JD', 'LastName': 'Tucker', 'Affiliation': 'University of North Carolina Project-China, 1 Global Health Center Office, 2nd Floor of Lao Gan Building, No. 7 Lujing Road, Yuexiu District, Guangzhou City, Guangdong Province, Guangzhou, China.'}]",BMC public health,['10.1186/s12889-020-09152-z'] 2725,32615994,Inhaled granulocyte-macrophage colony stimulating factor for mild-to-moderate autoimmune pulmonary alveolar proteinosis - a six month phase II randomized study with 24 months of follow-up.,"BACKGROUND Treatment of autoimmune pulmonary alveolar proteinosis (aPAP) by inhaled granulocyte-macrophage colony stimulating factor (GM-CSF) is considered safe and effective. Evidence of benefit from GM-CSG inhalation for mild to moderate aPAP patients is limited. METHODS In this multicenter, randomized, open-labeled clinical trial, 36 aPAP patients with mild to moderate disease severity were randomized into either the GM-CSF treatment group or control group. Inhaled GM-CSF was prescribed for 6 months, and patients received follow-up for another 18 months without treatment. Physiological features of the patients were analyzed. RESULTS There were 36 patients (19 in the treatment group, 17 in the control group) included. There were no significant differences in the primary endpoints as measured by the change of alveolar arterial oxygen gradient (A-aDO 2 ) from the baseline values to the values obtained during treatment or during the following 18-month non-treatment observation period [control group vs. treatment group: 0.51 ± 12.09 mmHg vs. -0.35 ± 13.76 mmHg, p = 0.848 (3 month); 1.85 ± 11.21 mmHg vs. 7.31 ± 8.81 mmHg, p = 0.146 (6 months); 6.05 ± 11.14 mmHg vs. 6.61 ± 10.64 mmHg, p = 0.899 (24 months)]). Percentage of diffusion capacity predicted (DLCO%) and percentage of total lung capacity predicted (TLC%), however, were significantly improved in the treatment group by the end of the study (P = 0.010 and 0.027). St. George Respiratory questionnaire (SGRQ) scores were better after 6 months treatment with GM-CSF compared to the control group, and the benefits of treatment were maintained throughout the observation period. No severe side effects were observed during the study. CONCLUSION Six months of inhaled GM-CSF treatment had no effect on the alveolar-arterial oxygen gradient in patients with mild to moderate pulmonary alveolar proteinosis. There were changes in some clinical or laboratory measures, but no clinically important changes were noted at the end of study. (Clinical Trial Registry: NCT02243228, Registered on September 17, 2014, https://www.clinicaltrials.gov/ct2/show/NCT02243228?term=NCT02243228&draw=2&rank=1 ).",2020,"There were no significant differences in the primary endpoints as measured by the change of alveolar arterial oxygen gradient (A-aDO 2 ) from the baseline values to the values obtained during treatment or during the following 18-month non-treatment observation period [control group vs. treatment group: 0.51 ± 12.09 mmHg vs. -0.35 ± 13.76 mmHg, p = 0.848 (3 month); 1.85 ± 11.21 mmHg vs. 7.31 ± 8.81 mmHg, p = 0.146 (6 months); 6.05 ± 11.14 mmHg vs. 6.61 ± 10.64 mmHg, p = 0.899 (24 months)]).","['36 patients (19 in the treatment group, 17 in the control group) included', 'patients with mild to moderate pulmonary alveolar proteinosis', '36 aPAP patients with mild to moderate disease severity', 'mild-to-moderate autoimmune pulmonary alveolar proteinosis - a six month phase II randomized study with 24\u2009months of follow-up', 'mild to moderate aPAP patients']","['inhaled GM-CSF', 'Inhaled granulocyte-macrophage colony stimulating factor', 'GM-CSG inhalation', 'inhaled granulocyte-macrophage colony stimulating factor (GM-CSF', 'GM-CSF treatment group or control group', 'Inhaled GM-CSF']","['alveolar-arterial oxygen gradient', 'Percentage of diffusion capacity predicted (DLCO%) and percentage of total lung capacity predicted (TLC', 'change of alveolar arterial oxygen gradient', 'St. George Respiratory questionnaire (SGRQ) scores', 'severe side effects']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0034050', 'cui_str': 'Pulmonary alveolar proteinosis'}, {'cui': 'C1970472', 'cui_str': 'Autoimmune pulmonary alveolar proteinosis'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]","[{'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0018183', 'cui_str': 'Granulocyte'}, {'cui': 'C0079784', 'cui_str': 'Colony-stimulating factor, macrophage'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C3203470', 'cui_str': 'Alveolar-arterial oxygen gradient'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0012222', 'cui_str': 'Diffusion'}, {'cui': 'C0040509', 'cui_str': 'Total lung capacity'}, {'cui': 'C0008569', 'cui_str': 'Thin Layer Chromatography'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C3472502', 'cui_str': ""Saint George's respiratory questionnaire score""}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}]",36.0,0.0306328,"There were no significant differences in the primary endpoints as measured by the change of alveolar arterial oxygen gradient (A-aDO 2 ) from the baseline values to the values obtained during treatment or during the following 18-month non-treatment observation period [control group vs. treatment group: 0.51 ± 12.09 mmHg vs. -0.35 ± 13.76 mmHg, p = 0.848 (3 month); 1.85 ± 11.21 mmHg vs. 7.31 ± 8.81 mmHg, p = 0.146 (6 months); 6.05 ± 11.14 mmHg vs. 6.61 ± 10.64 mmHg, p = 0.899 (24 months)]).","[{'ForeName': 'Xinlun', 'Initials': 'X', 'LastName': 'Tian', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Yanli', 'Initials': 'Y', 'LastName': 'Yang', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Lulu', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, The Affiliated Drum Tower Hospital of Nanjing University Medical School, Jiangsu, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Sui', 'Affiliation': 'Department of Radiology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Wenshuai', 'Initials': 'W', 'LastName': 'Xu', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Xue', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Xiaobei', 'Initials': 'X', 'LastName': 'Guo', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Lingshan', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Yusen', 'Initials': 'Y', 'LastName': 'Situ', 'Affiliation': 'Department of Biochemistry, Faculty of Medicine and Dentistry, University of Alberta, Edmonton, Canada.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Zhao', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Shuzhen', 'Initials': 'S', 'LastName': 'Meng', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Song', 'Affiliation': 'Department of Radiology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China.'}, {'ForeName': 'Yonglong', 'Initials': 'Y', 'LastName': 'Xiao', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, The Affiliated Drum Tower Hospital of Nanjing University Medical School, Jiangsu, China. yonglongxiao@sina.cn.'}, {'ForeName': 'Kai-Feng', 'Initials': 'KF', 'LastName': 'Xu', 'Affiliation': 'Department of Pulmonary and Critical Care Medicine, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing, China. xukf@pumch.cn.'}]",Orphanet journal of rare diseases,['10.1186/s13023-020-01450-4'] 2726,32616003,Differences in gait analysis and clinical outcome after TightRope® or screw fixation in acute syndesmosis rupture: study protocol for a prospective randomized pilot study.,"BACKGROUND Ankle sprains and fractures are most common injuries in orthopedic and trauma surgery. The concurrent occurrence of syndesmosis ruptures in these injuries represents a more complex problem, as they often remain undetected. A proper and accurate treatment of injuries of the syndesmosis, both isolated and combined with fractures, is necessary to avoid long-term consequences (chronic instability, cartilage damage, and post-traumatic osteoarthritis). The most popular treatment option is a static screw fixation and the newly developed dynamic TightRope® (Arthrex, Naples, FL, USA). The aim of this pilot study is to compare monitor ankle range of motion and maximum ankle power in gait as functional outcome parameters of instrumented gait analysis, as well as clinical and radiographic outcome for assessing the stabilization of acute syndesmosis rupture with either a static implant (a 3.5 mm metallic screw) or a dynamic device (TightRope®). METHODS This prospective, randomized, controlled, clinical trial will be carried out at the Center for Orthopedics, Trauma Surgery and Spinal Cord Injury of the University Hospital Heidelberg. Adult patients, who suffer from an acute syndesmosis rupture, both isolated and in combination with fractures of the lateral malleolus (Weber C and Maisonneuve fractures) and who are undergoing surgery at our trauma center will be included in our study. The patients will be randomized to the different treatment options (screw fixation or ""TightRope®""). Subsequent to the surgical treatment, all patients will receive the same standardized follow-up procedures including a gait analysis and MRI of the ankle at 6 months follow-up. The primary endpoint of the study is the successful healing of the syndesmosis and biomechanical investigation with gait analysis. DISCUSSION The results of the gait analysis from the current study will help to impartially and reliably evaluate the clinical and biomechanical outcome of both treatment options of acute syndesmosis ruptures. We hypothesize that the dynamic fixation provides an equivalent or better biomechanical, clinical, and radiographic outcome in comparison to the screw fixation. TRIAL REGISTRATION German Clinical Trials Register (DRKS) DRKS00013562 . Registered on July, 12, 2017.",2020,"A proper and accurate treatment of injuries of the syndesmosis, both isolated and combined with fractures, is necessary to avoid long-term consequences (chronic instability, cartilage damage, and post-traumatic osteoarthritis).","['Center for Orthopedics, Trauma Surgery and Spinal Cord Injury of the University Hospital Heidelberg', 'acute syndesmosis rupture', 'Adult patients, who suffer from an acute syndesmosis rupture, both isolated and in combination with fractures of the lateral malleolus (Weber C and Maisonneuve fractures) and who are undergoing surgery at our trauma center']","['static implant (a 3.5\u2009mm metallic screw) or a dynamic device (TightRope®', 'treatment options (screw fixation or ""TightRope®', 'TightRope® or screw fixation']",['successful healing of the syndesmosis and biomechanical investigation with gait analysis'],"[{'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0037929', 'cui_str': 'Spinal cord injury'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0224512', 'cui_str': 'Syndesmosis structure'}, {'cui': 'C0443294', 'cui_str': 'Ruptured'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205409', 'cui_str': 'Isolated'}, {'cui': 'C0555346', 'cui_str': 'Fracture of lateral malleolus'}, {'cui': 'C0582525', 'cui_str': 'weber'}, {'cui': 'C2863797', 'cui_str': 'Maisonneuve fracture'}, {'cui': 'C0040786', 'cui_str': 'Trauma center'}]","[{'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C3844010', 'cui_str': '3.5'}, {'cui': 'C0005975', 'cui_str': 'Bone screw'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}]","[{'cui': 'C1272703', 'cui_str': 'Successful'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0224512', 'cui_str': 'Syndesmosis structure'}, {'cui': 'C1261322', 'cui_str': 'Evaluation procedure'}, {'cui': 'C0558820', 'cui_str': 'Examination of gait'}]",,0.0619142,"A proper and accurate treatment of injuries of the syndesmosis, both isolated and combined with fractures, is necessary to avoid long-term consequences (chronic instability, cartilage damage, and post-traumatic osteoarthritis).","[{'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Doll', 'Affiliation': 'Clinic of Orthopedics, Trauma Surgery and Spinal Cord Injury, Heidelberg University Hospital, Schlierbacher Landstrasse 200a, 69118, Heidelberg, Germany. julian.doll@med.uni-heidelberg.de.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Waizenegger', 'Affiliation': 'Clinic of Orthopedics, Trauma Surgery and Spinal Cord Injury, Heidelberg University Hospital, Schlierbacher Landstrasse 200a, 69118, Heidelberg, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Bruckner', 'Affiliation': 'Institute of Medical Biometry and Informatics, University of Heidelberg, D-69118, Heidelberg, Germany.'}, {'ForeName': 'Gerhard', 'Initials': 'G', 'LastName': 'Schmidmaier', 'Affiliation': 'Clinic of Orthopedics, Trauma Surgery and Spinal Cord Injury, Heidelberg University Hospital, Schlierbacher Landstrasse 200a, 69118, Heidelberg, Germany.'}, {'ForeName': 'Sebastian I', 'Initials': 'SI', 'LastName': 'Wolf', 'Affiliation': 'Clinic of Orthopedics, Trauma Surgery and Spinal Cord Injury, Heidelberg University Hospital, Schlierbacher Landstrasse 200a, 69118, Heidelberg, Germany.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Fischer', 'Affiliation': 'Clinic of Orthopedics, Trauma Surgery and Spinal Cord Injury, Heidelberg University Hospital, Schlierbacher Landstrasse 200a, 69118, Heidelberg, Germany.'}]",Trials,['10.1186/s13063-020-04550-5'] 2727,32616017,Protocol for a randomized controlled trial comparing wound COmplications in elective midline laparotomies after FAscia Closure using two different Techniques Of Running sutures: COFACTOR trial.,"BACKGROUND Wound complications following midline laparotomies are common and the main source of postoperative morbidity including superficial or deep wound infection, skin dehiscence, fascia dehiscence, and incisional hernia. Abdominal closure complications are strongly associated with suture technique and material, in addition to other factors related to the patient and type of surgery performed. The traditional technique is to place the fascia sutures 1 cm apart and at least 1 cm away from the fascia edge. A Swedish study described a new technique of placing the sutures 5 mm apart and 5 mm away from the fascia edge, resulting in lower rates of abdominal wound complications. This study has a number of limitations. There is a need for improved quality evidence to convince the surgical community to change the closure technique of abdominal wounds aiming to reduce morbidity, which is exemplified in incisional hernias and other various postop complications. METHODS This is a 1:1 randomized, controlled, patient- and assessor-blinded, parallel design, superiority trial, with a primary endpoint of incisional hernia at 1 year. The study will be conducted at AUBMC over a 3-year period. Patients planned for a non-emergent midline laparotomy for general surgery or vascular procedure will be randomized to either fascia closure technique. In order to detect a drop of 12% in the incidence of incisional hernia, with 80% power and an alpha of 0.05, we will need to recruit 114 patients per arm. After adjusting for loss to follow-up, target recruitment is 274 subjects. We will compare both arms for the primary, secondary, and exploratory outcomes, using chi-square or t test as appropriate. Univariate and multivariate logistic regression will be done. DISCUSSION This trial will assess postop complications following abdominal midline wound closures via two different suturing techniques. This trial will generate evidence-based conclusions that will allow surgeons to assess the role of a new abdominal closure technique in decreasing short- and long-term postoperative complications, for a commonly performed procedure. TRIAL REGISTRATION ClinicalTrials.gov NCT03527433 . Registered on 17 May 2018 before starting participant enrollment.",2020,Patients planned for a non-emergent midline laparotomy for general surgery or vascular procedure will be randomized to either fascia closure technique.,"['274 subjects', 'elective midline laparotomies after FAscia Closure using two different Techniques Of Running sutures']","['non-emergent midline laparotomy for general surgery or vascular procedure', 'fascia closure technique']",['incisional hernia'],"[{'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0023038', 'cui_str': 'Laparotomy'}, {'cui': 'C0015641', 'cui_str': 'Fascial'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0035953', 'cui_str': 'Running'}, {'cui': 'C0009068', 'cui_str': 'Closure by suture'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0023038', 'cui_str': 'Laparotomy'}, {'cui': 'C1274039', 'cui_str': 'General surgery'}, {'cui': 'C0005847', 'cui_str': 'Blood vessel structure'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0015641', 'cui_str': 'Fascial'}, {'cui': 'C0030972', 'cui_str': 'Perceptual Completion Phenomena'}]","[{'cui': 'C0267716', 'cui_str': 'Incisional hernia'}]",,0.452634,Patients planned for a non-emergent midline laparotomy for general surgery or vascular procedure will be randomized to either fascia closure technique.,"[{'ForeName': 'Mohamad Hadi', 'Initials': 'MH', 'LastName': 'El Charif', 'Affiliation': 'Department of Surgery, American University of Beirut Medical Center, Riad El Solh, Beirut, 1107 2020, Lebanon.'}, {'ForeName': 'Zeina', 'Initials': 'Z', 'LastName': 'Hassan', 'Affiliation': 'Department of Surgery, American University of Beirut Medical Center, Riad El Solh, Beirut, 1107 2020, Lebanon.'}, {'ForeName': 'Jamal', 'Initials': 'J', 'LastName': 'Hoballah', 'Affiliation': 'Department of Surgery, American University of Beirut Medical Center, Riad El Solh, Beirut, 1107 2020, Lebanon.'}, {'ForeName': 'Mohamad', 'Initials': 'M', 'LastName': 'Khalife', 'Affiliation': 'Department of Surgery, American University of Beirut Medical Center, Riad El Solh, Beirut, 1107 2020, Lebanon.'}, {'ForeName': 'Eman', 'Initials': 'E', 'LastName': 'Sbaity', 'Affiliation': 'Department of Surgery, American University of Beirut Medical Center, Riad El Solh, Beirut, 1107 2020, Lebanon. es25@aub.edu.lb.'}]",Trials,['10.1186/s13063-020-04507-8'] 2728,32616109,Effects of virtual reality-based spatial cognitive training on hippocampal function of older adults with mild cognitive impairment.,"BACKGROUND To date, there is a controversy on effects of cognitive intervention to maintain or improve hippocampal function for older adults with mild cognitive impairment (MCI). OBJECTIVE The main objective of this study was to exam effects of virtual reality-based spatial cognitive training (VR-SCT) using VR on hippocampal function of older adults with MCI. METHOD Fifty-six older adults with MCI were randomly allocated to the experimental group (EG) that received the VR-SCT or the waitlist control group (CG) for a total of 24 sessions. To investigate effects of the VR-SCT on spatial cognition and episodic memory, the Weschsler Adult Intelligence Scale-Revised Block Design Test (WAIS-BDT) and the Seoul Verbal Learning Test (SVLT) were used. RESULTS During the sessions, the training performances gradually increased (p < .001). After the intervention, the EG showed significant greater improvements in the WAIS-BDT (p < .001, η2 = .667) and recall of the SVLT (p < .05, η2 =.094) compared to the CG but in recognition of the SVLT (p > .05, η2 =.001). CONCLUSION These results suggest that the VR-SCT might be clinically beneficial to enhance spatial cognition and episodic memory of older adults with MCI.",2020,"After the intervention, the EG showed significant greater improvements in the WAIS-BDT (p < .001, η2 = .667) and recall of the SVLT (p < .05, η2 =.094) compared to the CG but in recognition of the SVLT (","['older adults with MCI', 'older adults with mild cognitive impairment (MCI', 'older adults with mild cognitive impairment', 'Fifty-six older adults with MCI']","['cognitive intervention', 'virtual reality-based spatial cognitive training', 'virtual reality-based spatial cognitive training (VR-SCT) using VR', 'VR-SCT or the waitlist control group (CG', 'VR-SCT', 'SVLT ']","['recall of the SVLT', 'WAIS-BDT', 'hippocampal function', 'spatial cognition and episodic memory', 'spatial cognition and episodic memory, the Weschsler Adult Intelligence Scale-Revised Block Design Test (WAIS-BDT) and the Seoul Verbal Learning Test (SVLT']","[{'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C1270972', 'cui_str': 'Mild cognitive disorder'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1868940', 'cui_str': 'Cognitive training'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C3850150', 'cui_str': 'Seoul'}, {'cui': 'C0042531', 'cui_str': 'Verbal learning'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]","[{'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C3850150', 'cui_str': 'Seoul'}, {'cui': 'C0042531', 'cui_str': 'Verbal learning'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0021704', 'cui_str': 'Intelligence'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1527075', 'cui_str': 'Revision procedure'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0015320', 'cui_str': 'Designs, Experimental'}, {'cui': 'C0019564', 'cui_str': 'Hippocampal structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0561843', 'cui_str': 'Episodic memory'}]",56.0,0.0163504,"After the intervention, the EG showed significant greater improvements in the WAIS-BDT (p < .001, η2 = .667) and recall of the SVLT (p < .05, η2 =.094) compared to the CG but in recognition of the SVLT (","[{'ForeName': 'Jin-Hyuck', 'Initials': 'JH', 'LastName': 'Park', 'Affiliation': 'Department of Occupational Therapy, College of Medical Science, Soonchunhyang University, Asan-si, Republic of Korea.'}]",International psychogeriatrics,['10.1017/S1041610220001131'] 2729,32616128,[Anhydrous Ethanol Improves Efficiency of Radiofrequency Ablation for the Treatment of Benign Thyroid Nodules:A Prospective Randomized Controlled Trial].,"Objective To investigate the value of injecting a small amount of absolute ethanol into the benign solid nodules of the thyroid before radiofrequency ablation(RFA)to improve the efficiency of radiofrequency ablation. Methods A total of 98 eligible patients(98 nodules)with pathologically confirmed benign solid nodules who were treated in our center from December 2016 to February 2018 were included and randomized into ethanol ablation(EA)combined with radiofrequency ablation(RFA)group(EA+RFA group)and RFA group,with 49 patients in each group.Routine ultrasound,contrast-enhanced ultrasound(CEUS),and thyroid function test were performed before treatment and 1,3,6,and 12 months after treatment.The general information,treatment time,ablation energy,ablation power,postoperative nodule volume reduction ratio(VRR),symptom score(SS)and cosmetic score(CS),thyroid function level,and incidence of complications were compared between these two groups. Results The mean treatment time [(441.30±243.31)s vs. (790.70±349.82)s; t = 4.403, P =0.000],mean ablation energy [(3.92±2.01)kJ vs. (5.15±2.12)kJ; t =2.709, P =0.009],and mean ablation power [(6.07±1.44)W vs. (7.30±1.29)W; t =3.612, P =0.006] were significantly lower in the EA+RFA group than in the RFA group.At 3,6 and 12 months after surgery,the VRR in the EA+RFA group was(57.73±11.07)%( t =-3.16, P <0.001),(64.40±10.56)%( t =-5.45, P <0.001),and(77.29±8.48)%( t =-10.46, P <0.001),respectively;the VRR in the RFA group was(55.44±13.01)%( t =-1.76, P <0.001),(65.28±11.33)%( t =-5.09, P <0.001),and(75.17±9.84)%( t =-8.93, P <0.001),which were significantly smaller than those before surgery.There was no significant difference in VRR between the EA+RFA group and the RFA group at 1( t =3.41, P =0.33),3( t =2.05, P =0.21),6( t =2.77, P =0.49),and 12 months( t =5.05, P =0.10)after treatment.During the follow-up,no recurrence of nodules was observed on CEUS.In the EA+RFA group,the SS [(1.77±0.86) vs .(5.54±2.15); t =9.63, P <0.001] and the CS[(1.39±0.77) vs .(3.32±0.61); t =10.09, P =0.004]at 12 months after surgery were significantly lower than those before surgery.In the RFA group,SS [(1.63±1.04) vs .(5.90±1.79); t =12.72, P <0.001] and CS [(1.64±0.83) vs .(3.15±0.72); t =8.13, P =0.012] at 12 months after surgery were also significantly lower than those before surgery.The CSS in the EA+RFA group was significantly lower than that in the RFA group [(0.93±0.55) vs .(2.44±0.53); t =-11.70, P =0.007].Both groups had no significant change in thyroid function during the follow-up period,and no serious complications were observed. Conclusion Anhydrous alcohol injection can effectively improve the efficiency of radiofrequency ablation in treating benign solid thyroid nodules and is effective in reducing nodule volume,alleviating compressive symptoms,and decreasing cosmetic discomfort.",2020,"During the follow-up,no recurrence of nodules was observed on CEUS.In the EA+RFA group,the SS [(1.77±0.86) vs .(5.54±2.15);","['98 eligible patients(98 nodules)with pathologically confirmed benign solid nodules who were treated in our center from December 2016 to February 2018', 'group,with 49 patients in each group', 'Benign Thyroid Nodules']","['EA+RFA', '0.001),and(77.29±8.48', 'ethanol ablation(EA)combined with radiofrequency ablation(RFA)group(EA+RFA group)and RFA', 'Anhydrous Ethanol', 'Anhydrous alcohol injection']","['serious complications', 'Efficiency of Radiofrequency Ablation', 'VRR', 'cosmetic score(CS),thyroid function level,and incidence of complications', 'general information,treatment time,ablation energy,ablation power,postoperative nodule volume reduction', 'efficiency of radiofrequency ablation', 'cosmetic discomfort', 'thyroid function', 'recurrence of nodules', 'mean treatment time ']","[{'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0205183', 'cui_str': 'Benign'}, {'cui': 'C0205208', 'cui_str': 'Solid'}, {'cui': 'C0028259', 'cui_str': 'Nodule'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0749467', 'cui_str': 'Benign thyroid nodule'}]","[{'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0085733', 'cui_str': 'Absolute Alcohol'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}]","[{'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0850292', 'cui_str': 'Radio Frequency Ablation'}, {'cui': 'C0010164', 'cui_str': 'Cosmetic'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0040132', 'cui_str': 'Thyroid structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C1272583', 'cui_str': 'Ablation power'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0028259', 'cui_str': 'Nodule'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",,0.0379348,"During the follow-up,no recurrence of nodules was observed on CEUS.In the EA+RFA group,the SS [(1.77±0.86) vs .(5.54±2.15);","[{'ForeName': 'Yaqiong', 'Initials': 'Y', 'LastName': 'Zhu', 'Affiliation': 'Department of Ultrasound,Chinese PLA General Hospital,Beijing 100853,China.'}, {'ForeName': 'Zhuang', 'Initials': 'Z', 'LastName': 'Jin', 'Affiliation': 'Department of Ultrasound,Chinese PLA General Hospital,Beijing 100853,China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Ultrasound,Chinese PLA General Hospital,Beijing 100853,China.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Jiang', 'Affiliation': 'Department of Ultrasound,Chinese PLA General Hospital,Beijing 100853,China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Yan', 'Affiliation': 'Department of Ultrasound,Chinese PLA General Hospital,Beijing 100853,China.'}, {'ForeName': 'Xiaoqi', 'Initials': 'X', 'LastName': 'Tian', 'Affiliation': 'Department of Ultrasound,Chinese PLA General Hospital,Beijing 100853,China.'}, {'ForeName': 'Mingbo', 'Initials': 'M', 'LastName': 'Zhang', 'Affiliation': 'Department of Ultrasound,Chinese PLA General Hospital,Beijing 100853,China.'}, {'ForeName': 'Yukun', 'Initials': 'Y', 'LastName': 'Luo', 'Affiliation': 'Department of Ultrasound,Chinese PLA General Hospital,Beijing 100853,China.'}]",Zhongguo yi xue ke xue yuan xue bao. Acta Academiae Medicinae Sinicae,['10.3881/j.issn.1000-503X.11512'] 2730,32616150,Baroreflex Activation Therapy in Patients With Heart Failure With Reduced Ejection Fraction.,"BACKGROUND This study demonstrated the safety and effectiveness of baroreflex activation therapy (BAT) in patients with heart failure with reduced ejection fraction (HFrEF). OBJECTIVES The BeAT-HF (Baroreflex Activation Therapy for Heart Failure) trial was a multicenter, prospective, randomized, controlled trial; subjects were randomized 1:1 to receive either BAT plus optimal medical management (BAT group) or optimal medical management alone (control group). METHODS Four patient cohorts were created from 408 randomized patients with HFrEF using the following enrollment criteria: current New York Heart Association (NYHA) functional class III or functional class II (patients who had a recent history of NYHA functional class III); ejection fraction ≤35%; stable medical management for ≥4 weeks; and no Class I indication for cardiac resynchronization therapy. Effectiveness endpoints were the change from baseline to 6 months in 6-min hall walk distance (6MHW), Minnesota Living with HF Questionnaire quality-of-life (QOL) score, and N-terminal pro-B-type natriuretic peptide (NT-proBNP) levels. The safety endpoint included the major adverse neurological or cardiovascular system or procedure-related event rate (MANCE). RESULTS Results from, timeline and rationale for, cohorts A, B, and C are presented in detail in the text. Cohort D, which represented the intended use population that reflected the U.S. Food and Drug Administration-approved instructions for use (enrollment criteria plus NT-proBNP <1,600 pg/ml), consisted of 245 patients followed-up for 6 months (120 in the BAT group and 125 in the control group). BAT was safe and significantly improved QOL, 6MHW, and NT-proBNP. In the BAT group versus the control group, QOL score decreased (Δ = -14.1; 95% confidence interval [CI]: -19 to -9; p < 0.001), 6MHW distance increased (Δ = 60 m; 95% CI: 40 to 80 m; p < 0.001), NT-proBNP decreased (Δ = -25%; 95% CI: -38% to -9%; p = 0.004), and the MANCE free rate was 97% (95% CI: 93% to 100%; p < 0.001). CONCLUSIONS BAT was safe and significantly improved QOL, exercise capacity, and NT-proBNP. (Baroreflex Activation Therapy for Heart Failure [BeAT-HF]; NCT02627196).",2020,"In the BAT group versus the control group, QOL score decreased (Δ = -14.1; 95% confidence interval [CI]: -19 to -9; p < 0.001), 6MHW distance increased (Δ = 60 m; 95% CI: 40 to 80 m; p < 0.001), NT-proBNP decreased (Δ = -25%; 95% CI: -38% to -9%; p = 0.004), and the MANCE free rate was 97% (95% CI: 93% to 100%; p < 0.001). ","['Heart\xa0Failure', 'Patients With Heart', 'patients with heart failure with reduced ejection fraction (HFrEF', 'Four patient cohorts were created from 408 randomized patients with HFrEF using the following enrollment criteria']","['baroreflex activation therapy (BAT', 'BeAT-HF (Baroreflex Activation Therapy', 'BAT plus optimal medical management (BAT group) or optimal medical management alone (control group', 'BeAT-HF', 'Baroreflex Activation Therapy', 'current New York Heart Association (NYHA) functional class III or functional class II (patients who had a recent history of NYHA functional class III); ejection fraction\xa0≤35%; stable medical management for\xa0≥4\xa0weeks; and no Class I indication for cardiac resynchronization therapy', 'BAT']","['QOL, exercise capacity, and NT-proBNP', 'NT-proBNP', '6-min hall walk distance (6MHW), Minnesota Living with HF Questionnaire quality-of-life (QOL) score, and N-terminal pro-B-type natriuretic peptide (NT-proBNP) levels', '6MHW distance', 'MANCE free rate', 'QOL score', 'major adverse neurological or cardiovascular system or procedure-related event rate (MANCE', 'QOL, 6MHW, and NT-proBNP']","[{'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C3839346', 'cui_str': 'Heart failure with reduced ejection fraction'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C4517769', 'cui_str': '408'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0206162', 'cui_str': 'Baroreceptor reflex'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C1527374', 'cui_str': 'Group Therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0027976', 'cui_str': 'New York'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0441887', 'cui_str': 'Class 3'}, {'cui': 'C0441886', 'cui_str': 'Class 2'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0441885', 'cui_str': 'Class 1'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C1167956', 'cui_str': 'Cardiac resynchronisation therapy'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0754710', 'cui_str': 'Pro-brain natriuretic peptide'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0429886', 'cui_str': 'Walking distance'}, {'cui': 'C0026183', 'cui_str': 'Minnesota'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0332296', 'cui_str': 'Free of'}]",408.0,0.102149,"In the BAT group versus the control group, QOL score decreased (Δ = -14.1; 95% confidence interval [CI]: -19 to -9; p < 0.001), 6MHW distance increased (Δ = 60 m; 95% CI: 40 to 80 m; p < 0.001), NT-proBNP decreased (Δ = -25%; 95% CI: -38% to -9%; p = 0.004), and the MANCE free rate was 97% (95% CI: 93% to 100%; p < 0.001). ","[{'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Zile', 'Affiliation': 'Medical University of South Carolina, Charleston, South Carolina; Ralph H. Johnson Department of Veterans Affairs Medical Center, Charleston, South Carolina. Electronic address: zilem@musc.edu.'}, {'ForeName': 'JoAnn', 'Initials': 'J', 'LastName': 'Lindenfeld', 'Affiliation': 'Vanderbilt Heart and Vascular Institute, Nashville, Tennessee.'}, {'ForeName': 'Fred A', 'Initials': 'FA', 'LastName': 'Weaver', 'Affiliation': 'Division of Vascular Surgery and Endovascular Therapy, Keck School of Medicine, University of Southern California, Los Angeles, California.'}, {'ForeName': 'Faiez', 'Initials': 'F', 'LastName': 'Zannad', 'Affiliation': ""Inserm Centre d'Investigation, CHU de Nancy, Institute Lorrain du Coeur et des Vaisseaux, Université de Lorraine, Nancy, France.""}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Galle', 'Affiliation': 'CVRx, Inc., Minneapolis, Minnesota.'}, {'ForeName': 'Tyson', 'Initials': 'T', 'LastName': 'Rogers', 'Affiliation': 'NAMSA, Inc., Minneapolis, Minneapolis.'}, {'ForeName': 'William T', 'Initials': 'WT', 'LastName': 'Abraham', 'Affiliation': 'Division of Cardiovascular Medicine, The Ohio State University, Columbus, Ohio.'}]",Journal of the American College of Cardiology,['10.1016/j.jacc.2020.05.015'] 2731,32616158,Association of Statin Use With Disability-Free Survival and Cardiovascular Disease Among Healthy Older Adults.,"BACKGROUND There is clinical uncertainty regarding the benefits and harms of prescribing statins in healthy subjects ≥70 years of age. OBJECTIVES The aim of this study was to examine the association among statins, dementia-free and disability-free survival, and cardiovascular disease (CVD) among healthy older adults using data from the ASPREE (Aspirin in Reducing Events in the Elderly) trial. METHODS ASPREE was a randomized trial of 19,114 community-dwelling persons in Australia and the United States ≥65 years of age and free of documented CVD, dementia, and disability. Data were collected for those ≥70 years of age, and participants who took statins at baseline were compared with those who did not using Cox proportional hazards regression with inverse probability weighting. The primary outcome, referred to as ""disability-free survival,"" was a composite of all-cause mortality, dementia, or persistent physical disability. Other outcomes included the individual components of the composite outcome, major adverse cardiovascular events, fatal CVD, myocardial infarction, and stroke. RESULTS Of the 18,096 included participants (median age 74.2 years, 56.0% women), 5,629 took statins at baseline. Over a median follow-up period of 4.7 years, baseline statin use was not associated with disability-free survival or with the risk for all-cause mortality or dementia. However, it was associated with lower risks for physical disability and all cardiovascular outcomes. CONCLUSIONS Among healthy community-dwelling adults ≥70 years of age, statin use may be beneficial for preventing physical disability and CVD but not beneficial for prolonging disability-free survival or avoiding death or dementia. Future clinical trials are needed to confirm these findings.",2020,"Over a median follow-up period of 4.7 years, baseline statin use was not associated with disability-free survival or with the risk for all-cause mortality or dementia.","['19,114 community-dwelling persons in Australia and the United States ≥65\xa0years of age and free of documented CVD, dementia, and disability', 'Of the 18,096 included participants (median age 74.2 years, 56.0% women), 5,629 took statins at baseline', 'Healthy Older Adults', 'healthy older adults', 'healthy community-dwelling adults\xa0≥70 years', 'healthy subjects\xa0≥70 years of age']",['ASPREE (Aspirin'],"['individual components of\xa0the\xa0composite outcome, major adverse cardiovascular events, fatal CVD, myocardial infarction, and stroke', 'physical disability and all cardiovascular outcomes', 'disability-free survival', 'statins, dementia-free and disability-free survival, and cardiovascular disease (CVD', 'referred to as ""disability-free survival,"" was a composite of all-cause mortality, dementia, or persistent physical disability']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C4045975', 'cui_str': 'Community Dwelling'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0004057', 'cui_str': 'Aspirin'}]","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0520817', 'cui_str': 'Physical handicap'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0360714', 'cui_str': 'HMG-CoA reductase inhibitor'}, {'cui': 'C0011265', 'cui_str': 'Presenile dementia'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C1278569', 'cui_str': 'WAS A'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}]",19114.0,0.159088,"Over a median follow-up period of 4.7 years, baseline statin use was not associated with disability-free survival or with the risk for all-cause mortality or dementia.","[{'ForeName': 'Zhen', 'Initials': 'Z', 'LastName': 'Zhou', 'Affiliation': 'Menzies Institute for Medical Research, University of Tasmania, Hobart, Tasmania, Australia. Electronic address: zhen.zhou@utas.edu.au.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Ofori-Asenso', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Victoria, Australia; Copenhagen Centre for Regulatory Science, Department of Pharmacy, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Andrea J', 'Initials': 'AJ', 'LastName': 'Curtis', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Monique', 'Initials': 'M', 'LastName': 'Breslin', 'Affiliation': 'Menzies Institute for Medical Research, University of Tasmania, Hobart, Tasmania, Australia.'}, {'ForeName': 'Rory', 'Initials': 'R', 'LastName': 'Wolfe', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'John J', 'Initials': 'JJ', 'LastName': 'McNeil', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Anne M', 'Initials': 'AM', 'LastName': 'Murray', 'Affiliation': 'Berman Center for Outcomes and Clinical Research, Hennepin Healthcare Research Institute, Division of Geriatrics, Department of Medicine, Hennepin HealthCare, Minneapolis, Minnesota; University of Minnesota, Minneapolis, Minnesota.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Ernst', 'Affiliation': 'Department of Pharmacy Practice and Science, College of Pharmacy, University of Iowa, Iowa City, Iowa; Department of Family Medicine, Carver College of Medicine, University of Iowa, Iowa City, Iowa.'}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': 'Reid', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Victoria, Australia; School of Public Health, Curtin University, Perth, Western Australia, Australia.'}, {'ForeName': 'Jessica E', 'Initials': 'JE', 'LastName': 'Lockery', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Robyn L', 'Initials': 'RL', 'LastName': 'Woods', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Andrew M', 'Initials': 'AM', 'LastName': 'Tonkin', 'Affiliation': 'Department of Epidemiology and Preventive Medicine, Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Mark R', 'Initials': 'MR', 'LastName': 'Nelson', 'Affiliation': 'Menzies Institute for Medical Research, University of Tasmania, Hobart, Tasmania, Australia.'}]",Journal of the American College of Cardiology,['10.1016/j.jacc.2020.05.016'] 2732,32616309,"Neutrophil extracellular trapping and angiogenesis biomarkers after intravenous or inhalation anaesthesia with or without intravenous lidocaine for breast cancer surgery: a prospective, randomised trial.","BACKGROUND Experimental and, retrospective, clinical data indicate that anaesthetic technique might influence the risk of metastasis after cancer surgery. Neutrophil extracellular trapping (NETosis) is an immunological mechanism strongly linked with increased metastatic risk. Similarly, vascular endothelial growth factor A is linked to angiogenesis implicated in recurrence. Therefore, we investigated the effect of four anaesthetic techniques on NETosis and angiogenic factors expression in women undergoing breast cancer resection. METHODS Women (n=120) undergoing primary breast tumour resection were randomly assigned to receive one of four anaesthetics: sevoflurane (S), sevoflurane plus i.v. lidocaine (SL), propofol (P), and propofol plus i.v. lidocaine (PL). Venous blood was collected before induction and 20-28 h after operation. Neutrophil myeloperoxidase and citrullinated histone H3, biomarkers of NETosis, and biomarkers of angiogenesis were measured by enzyme-linked immunosorbent assay. RESULTS Patient characteristic data and perioperative management did not differ between study groups. The anaesthetic technique including lidocaine decreased expression of citrullinated histone H3 compared with no lidocaine (109 [23] vs 125 [22] ng ml -1 , P=0.01 for SL and S and 98 [14] vs 130 [32] mg ml -1 , P=0.007, for PL and P, respectively). Similarly, myeloperoxidase was decreased by lidocaine (8.5 [3.4] vs 10.8 [1.8] ng ml -1 , P=0.03 for SL and S and 8.6 [3.1] vs 11.6 [2.5] ng ml -1 , P=0.01 for PL and P, respectively). Lidocaine also decreased expression of matrix metalloproteinase 3 (MMP3) but not MMP9, whichever anaesthetic was used. Vascular endothelial growth factor A concentrations were not significantly influenced by the anaesthetic technique. CONCLUSIONS I.V. perioperative lidocaine decreased postoperative expression of NETosis and MMP3, regardless of general anaesthetic technique. This supports the hypothesis that i.v. lidocaine during cancer surgery of curative intent might reduce recurrence. CLINICAL TRIAL REGISTRATION NCT02839668.",2020,"Lidocaine also decreased expression of matrix metalloproteinase 3 (MMP3) but not MMP9, whichever anaesthetic was used.","['Women (n=120) undergoing primary breast tumour resection', 'breast cancer surgery', 'women undergoing breast cancer resection']","['Lidocaine', 'lidocaine', 'anaesthetics: sevoflurane (S), sevoflurane plus i.v', 'lidocaine (SL), propofol (P), and propofol plus i.v', 'Neutrophil extracellular trapping (NETosis', 'inhalation anaesthesia with or without intravenous lidocaine', 'lidocaine (PL']","['expression of matrix metalloproteinase 3 (MMP3', 'Vascular endothelial growth factor', 'Neutrophil myeloperoxidase and citrullinated histone H3, biomarkers of NETosis, and biomarkers of angiogenesis', 'NETosis and angiogenic factors expression', 'postoperative expression of NETosis and MMP3', 'Venous blood', 'myeloperoxidase']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C1458155', 'cui_str': 'Neoplasm of breast'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0002930', 'cui_str': 'Anesthetics'}, {'cui': 'C0074414', 'cui_str': 'sevoflurane'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear leukocyte'}, {'cui': 'C0521119', 'cui_str': 'Extracellular'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}]","[{'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0164371', 'cui_str': 'Stromelysin 1'}, {'cui': 'C0078058', 'cui_str': 'Vascular endothelial growth factor'}, {'cui': 'C0443783', 'cui_str': 'Neutrophil myeloperoxidase'}, {'cui': 'C0019647', 'cui_str': 'Histone H3'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0002976', 'cui_str': 'Angiogenic Factor'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0229667', 'cui_str': 'Venous blood'}, {'cui': 'C0027021', 'cui_str': 'Peroxidase'}]",,0.113979,"Lidocaine also decreased expression of matrix metalloproteinase 3 (MMP3) but not MMP9, whichever anaesthetic was used.","[{'ForeName': 'Elena V', 'Initials': 'EV', 'LastName': 'Galoș', 'Affiliation': '1st Department of Anaesthesiology and Intensive Care, Iuliu Hatieganu University of Medicine and Pharmacy, Cluj-Napoca, Romania; EU COST Action 15204: European Cooperation in Science and Technology, The European Platform for Outcomes Research into Perioperative Interventions during Surgery for Cancer: The EURO-PERISCOPE Network.'}, {'ForeName': 'Tiberiu-Florin', 'Initials': 'TF', 'LastName': 'Tat', 'Affiliation': 'Prof. Dr. Ion Chiricuta Institute of Oncology, Cluj-Napoca, Romania.'}, {'ForeName': 'Răzvan', 'Initials': 'R', 'LastName': 'Popa', 'Affiliation': 'Prof. Dr. Ion Chiricuta Institute of Oncology, Cluj-Napoca, Romania.'}, {'ForeName': 'Catalin-Iulian', 'Initials': 'CI', 'LastName': 'Efrimescu', 'Affiliation': 'Department of Anaesthesiology & Perioperative Medicine, Mater Misericordiae University Hospital, School of Medicine, University College Dublin, Dublin, Ireland; EU COST Action 15204: European Cooperation in Science and Technology, The European Platform for Outcomes Research into Perioperative Interventions during Surgery for Cancer: The EURO-PERISCOPE Network.'}, {'ForeName': 'Dylan', 'Initials': 'D', 'LastName': 'Finnerty', 'Affiliation': 'Department of Anaesthesiology & Perioperative Medicine, Mater Misericordiae University Hospital, School of Medicine, University College Dublin, Dublin, Ireland; EU COST Action 15204: European Cooperation in Science and Technology, The European Platform for Outcomes Research into Perioperative Interventions during Surgery for Cancer: The EURO-PERISCOPE Network.'}, {'ForeName': 'Donal J', 'Initials': 'DJ', 'LastName': 'Buggy', 'Affiliation': 'Department of Anaesthesiology & Perioperative Medicine, Mater Misericordiae University Hospital, School of Medicine, University College Dublin, Dublin, Ireland; Department of Outcomes Research, Anaesthesiology Institute, Cleveland Clinic, Cleveland, OH, USA; EU COST Action 15204: European Cooperation in Science and Technology, The European Platform for Outcomes Research into Perioperative Interventions during Surgery for Cancer: The EURO-PERISCOPE Network.'}, {'ForeName': 'Daniela C', 'Initials': 'DC', 'LastName': 'Ionescu', 'Affiliation': '1st Department of Anaesthesiology and Intensive Care, Iuliu Hatieganu University of Medicine and Pharmacy, Cluj-Napoca, Romania; Department of Outcomes Research, Anaesthesiology Institute, Cleveland Clinic, Cleveland, OH, USA; EU COST Action 15204: European Cooperation in Science and Technology, The European Platform for Outcomes Research into Perioperative Interventions during Surgery for Cancer: The EURO-PERISCOPE Network. Electronic address: daniela_ionescu@umfcluj.ro.'}, {'ForeName': 'Carmen M', 'Initials': 'CM', 'LastName': 'Mihu', 'Affiliation': 'Department of Histology, Iuliu Hatieganu University of Medicine and Pharmacy, Cluj-Napoca, Romania.'}]",British journal of anaesthesia,['10.1016/j.bja.2020.05.003'] 2733,32616406,Diagnostic Assessment of Lower Urinary Tract Symptoms in Men Considering Prostate Surgery: A Noninferiority Randomised Controlled Trial of Urodynamics in 26 Hospitals.,"BACKGROUND Prostate surgery can improve lower urinary tract symptoms (LUTS) by relieving bladder outlet obstruction (BOO). However, surgery is less effective without BOO, or if detrusor underactivity is present. Urodynamics (UDS) can identify BOO and measure detrusor activity, but evidence in clinical practice is lacking. OBJECTIVE Urodynamics for Prostate Surgery Trial: Randomised Evaluation of Assessment Methods (UPSTREAM) aimed to evaluate whether a care pathway including UDS would reduce surgery without increasing urinary symptoms. DESIGN, SETTING, AND PARTICIPANTS UPSTREAM is a pragmatic, noninferiority, randomised controlled trial in men with bothersome LUTS, in whom surgery was an option, in 26 hospitals in England (ISRCTN56164274). INTERVENTION Participants were randomised (1:1) to routine care (RC) diagnostic tests, or RC plus UDS. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS The primary outcome was the International Prostate Symptom Score (IPSS; patient-reported outcome scale from 0 to 35 points) 18 mo after randomisation, with a noninferiority margin of 1 point. Urological surgery rates were a key secondary outcome. The primary outcome was compared between the arms using linear regression, analysed on an intention-to-treat basis. RESULTS AND LIMITATIONS Between October 2014 and December 2016, 820 men (median age 68 yr) were randomised (393 and 427 in the RC and UDS arms, respectively). The UDS arm showed noninferiority of the mean IPSSs (UDS 12.6; RC 13.1; adjusted difference at 18 mo -0.33 [95% confidence interval {CI} -1.47, +0.80]). In the UDS arm, 153/408 (38%) received surgery compared with 138/384 (36%) in the RC arm (adjusted odds ratio 1.05; 95% CI 0.77, 1.43). A total of 428 adverse events (UDS 234; RC 194) were recorded, with related events similar in both arms and 11 unrelated deaths. CONCLUSIONS In this population, the UDS randomised group was noninferior to RC for the IPSS but did not reduce surgical rates. This study shows that routine use of UDS in the evaluation of uncomplicated LUTS has a limited role and should be used selectively. PATIENT SUMMARY For men with uncomplicated lower urinary tract symptoms, symptom improvements after treatment and the number of operations performed are similar, irrespective of whether or not urodynamic tests are conducted in addition to routine tests. Accordingly, routine use of urodynamics has a limited role in this population group.",2020,"For men with uncomplicated lower urinary tract symptoms, symptom improvements after treatment and the number of operations performed are similar, irrespective of whether or not urodynamic tests are conducted in addition to routine tests.","['Men Considering Prostate Surgery', 'Prostate Surgery Trial', 'Between October 2014 and December 2016, 820 men (median age 68 yr', 'men with bothersome LUTS, in whom surgery was an option, in 26 hospitals in England (ISRCTN56164274', '26 Hospitals']","['routine care (RC) diagnostic tests, or RC plus UDS']","['surgical rates', 'International Prostate Symptom Score (IPSS; patient-reported outcome scale', 'intention-to-treat basis', 'mean IPSSs', 'Urological surgery rates']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0194790', 'cui_str': 'Operation on prostate'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0574785', 'cui_str': 'Lower urinary tract symptoms'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0014282', 'cui_str': 'England'}]","[{'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0430022', 'cui_str': 'Diagnostic procedure'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0042059', 'cui_str': 'Urodynamics'}]","[{'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C1998280', 'cui_str': 'International prostate symptom score'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1292734', 'cui_str': 'Treatment intent'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C3653764', 'cui_str': 'UROLOGICALS'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]",,0.422983,"For men with uncomplicated lower urinary tract symptoms, symptom improvements after treatment and the number of operations performed are similar, irrespective of whether or not urodynamic tests are conducted in addition to routine tests.","[{'ForeName': 'Marcus J', 'Initials': 'MJ', 'LastName': 'Drake', 'Affiliation': 'Translational Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK; Bristol Urological Institute, North Bristol NHS Trust, Bristol, UK. Electronic address: marcus.drake@bristol.ac.uk.'}, {'ForeName': 'Amanda L', 'Initials': 'AL', 'LastName': 'Lewis', 'Affiliation': 'Bristol Randomised Trials Collaboration (BRTC), Bristol Trials Centre, University of Bristol, Bristol, UK; Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Grace J', 'Initials': 'GJ', 'LastName': 'Young', 'Affiliation': 'Bristol Randomised Trials Collaboration (BRTC), Bristol Trials Centre, University of Bristol, Bristol, UK; Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Abrams', 'Affiliation': 'Bristol Urological Institute, North Bristol NHS Trust, Bristol, UK.'}, {'ForeName': 'Peter S', 'Initials': 'PS', 'LastName': 'Blair', 'Affiliation': 'Bristol Randomised Trials Collaboration (BRTC), Bristol Trials Centre, University of Bristol, Bristol, UK; Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Chapple', 'Affiliation': 'Sheffield Teaching Hospitals NHS Trust, Royal Hallamshire Hospital, Sheffield, UK.'}, {'ForeName': 'Cathryn M A', 'Initials': 'CMA', 'LastName': 'Glazener', 'Affiliation': 'Health Services Research Unit, University of Aberdeen, Aberdeen, Scotland, UK.'}, {'ForeName': 'Jeremy', 'Initials': 'J', 'LastName': 'Horwood', 'Affiliation': 'Bristol Randomised Trials Collaboration (BRTC), Bristol Trials Centre, University of Bristol, Bristol, UK; Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'John S', 'Initials': 'JS', 'LastName': 'McGrath', 'Affiliation': 'University of Exeter Medical School, Exeter, UK.'}, {'ForeName': 'Sian', 'Initials': 'S', 'LastName': 'Noble', 'Affiliation': 'Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.'}, {'ForeName': 'Gordon T', 'Initials': 'GT', 'LastName': 'Taylor', 'Affiliation': 'University of Plymouth, Plymouth, UK.'}, {'ForeName': 'J Athene', 'Initials': 'JA', 'LastName': 'Lane', 'Affiliation': 'Bristol Randomised Trials Collaboration (BRTC), Bristol Trials Centre, University of Bristol, Bristol, UK; Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.'}]",European urology,['10.1016/j.eururo.2020.06.004'] 2734,32616433,Comparative Cost-effectiveness of Aflibercept and Ramucirumab in Combination with Irinotecan and Fluorouracil-based Therapy for the Second-line Treatment of Metastatic Colorectal Cancer in Japan.,"PURPOSE The addition of aflibercept (AFL) or ramucirumab (RAM) to folinic acid, fluorouracil, and irinotecan (FOLFIRI) prolongs overall survival and progression-free survival compared with FOLFIRI alone in patients with metastatic colorectal cancer (mCRC) as second-line therapy. Although these combination regimens are recommended among the standard therapies, significant additional cost is a concern. The comparative cost-effectiveness of AFL and RAM was examined from the perspective of the Japanese health care payer. METHODS A partitioned survival analysis was constructed. The data sources were the VELOUR (Aflibercept Versus Placebo in Combination With Irinotecan and 5-FU in the Treatment of Patients With Metastatic Colorectal Cancer After Failure of an Oxaliplatin Based Regimen) and RAISE (Ramucirumab Versus Placebo in Combination With Second-Line FOLFIRI in Patients With Metastatic Colorectal Carcinoma That Progressed During or After First-Line Therapy With Bevacizumab, Oxaliplatin, and a Fluoropyrimidine) trials, which compared FOLFIRI alone with AFL or RAM in second-line treatment for mCRC. The cost and effectiveness of the combination of AFL or RAM with FOLFIRI were compared with those of FOLFIRI alone and examined between both agents in a 10-year time horizon. The health outcomes were life-years (LYs) and quality-adjusted life-years (QALYs). The costs were 2019 revisions to the drug prices and medical fees. The robustness of the model was verified by 1-way sensitivity analyses and a probability sensitivity analysis. A 2% annual discount was applied to the expenses and QALYs. A willingness-to-pay threshold of ¥7.5 million was used. FINDINGS Compared with FOLFIRI alone, combination AFL or RAM with FOLFIRI had incremental effects of 0.173 QALYs (0.253 LYs) and 0.137 QALYs (0.197 LYs), incremental costs of ¥3,423,481 (US $31,010) and ¥5,766,106 (US $52,229), and incremental cost-effectiveness ratios of ¥19, 836, 504 (US $179,678) and ¥41, 947, 989 (US $379,964) per QALY, respectively. Results of 1-way sensitivity analyses and probability sensitivity analysis all exceeded a willingness-to-pay threshold of ¥7.5 million. In the comparison of the 2 agents, AFL was a dominant over RAM. IMPLICATIONS Adding AFL or RAM to FOLFIRI in the second line of mCRC treatment was not cost-effective in the Japanese health care system. On the basis of the results of this study, in the treatment of mCRC, it will be necessary to adjust the prices of AFL and RAM with the improvement of clinical parameters, such as survival time and adverse events. Of the 2 agents, AFL was more cost-effective than RAM.",2020,"Compared with FOLFIRI alone, combination AFL or RAM with FOLFIRI had incremental effects of 0.173 QALYs (0.253 LYs) and 0.137 QALYs (0.197 LYs), incremental costs of ¥3,423,481 (US $31,010) and ¥5,766,106 (US $52,229), and incremental cost-effectiveness ratios of ¥19, 836, 504 (US $179,678) and ¥41, 947, 989 (US $379,964) per QALY, respectively.","['Patients', 'Patients With Metastatic Colorectal Cancer', 'Metastatic Colorectal Cancer in Japan', 'With Metastatic Colorectal Carcinoma', 'patients with metastatic colorectal cancer (mCRC']","['Irinotecan and Fluorouracil-based Therapy', 'FOLFIRI alone with AFL or RAM', 'VELOUR (Aflibercept Versus Placebo', 'AFL', 'Aflibercept and Ramucirumab', 'AFL and RAM', 'FOLFIRI alone', 'Irinotecan and 5-FU', 'aflibercept (AFL) or ramucirumab (RAM) to folinic acid, fluorouracil, and irinotecan (FOLFIRI', 'Oxaliplatin Based Regimen) and RAISE (Ramucirumab Versus Placebo', 'Bevacizumab, Oxaliplatin, and a Fluoropyrimidine']","['life-years (LYs) and quality-adjusted life-years (QALYs', 'survival time and adverse events', 'incremental cost-effectiveness ratios', 'cost and effectiveness', 'overall survival and progression-free survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4721579', 'cui_str': 'Secondary malignant neoplasm of colon and/or rectum'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0009402', 'cui_str': 'Colorectal cancer'}]","[{'cui': 'C0123931', 'cui_str': 'irinotecan'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0023413', 'cui_str': 'Leucovorin'}, {'cui': 'C1134659', 'cui_str': 'aflibercept'}, {'cui': 'C2742502', 'cui_str': 'ramucirumab'}, {'cui': 'C0078152', 'cui_str': 'velour'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0442818', 'cui_str': 'Raised'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}]","[{'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0080071', 'cui_str': 'Quality adjusted life years'}, {'cui': 'C2919552', 'cui_str': 'Survival time'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",,0.0161037,"Compared with FOLFIRI alone, combination AFL or RAM with FOLFIRI had incremental effects of 0.173 QALYs (0.253 LYs) and 0.137 QALYs (0.197 LYs), incremental costs of ¥3,423,481 (US $31,010) and ¥5,766,106 (US $52,229), and incremental cost-effectiveness ratios of ¥19, 836, 504 (US $179,678) and ¥41, 947, 989 (US $379,964) per QALY, respectively.","[{'ForeName': 'Munenobu', 'Initials': 'M', 'LastName': 'Kashiwa', 'Affiliation': 'Division of Pharmacy, Graduate School of Medical Sciences, Kanazawa University, Kanazawa, Japan; Department of Pharmacy, First Towakai Hospital, Takatsuki, Japan. Electronic address: munenobuk@stu.kanazawa-u.ac.jp.'}, {'ForeName': 'Ryo', 'Initials': 'R', 'LastName': 'Matsushita', 'Affiliation': 'Division of Pharmaceutical Sciences, Graduate School of Medical Sciences, Kanazawa University, Kanazawa, Japan.'}]",Clinical therapeutics,['10.1016/j.clinthera.2020.05.013'] 2735,32616452,Effect of family empowerment education on pulmonary function and quality of life of children with asthma and their parents in Tunisia: A randomized controlled trial.,"PURPOSE Patient education is fundamental in asthma management, especially at pediatric age. It is increasingly recognized as effective in reducing the burden of the disease, but is less clear in improving the quality of life of children with asthma and their parents. This study assessed the effect of an asthma therapeutic education program on pulmonary function and quality of life in children with asthma and their parents. DESIGN AND METHODS A monocentric randomized controlled trial conducted in Farhat Hached University Hospital of Sousse (Tunisia) from May 2018 to September 2019. Thirty-seven families in the experimental group and 39 families in the control group received allocated intervention at baseline. Thirty-four families in each group completed the study at the 12-month follow-up. RESULTS The intervention significantly improved quality of life scores of children and their parents (all p < 0.05). Children in the experimental group had significantly better forced expiratory maneuver than children in the control group. Nonetheless, the FEV1/FVC ratio did not show any significant difference in the experimental and control group (p = 0.9; p = 0.14, respectively). CONCLUSIONS This study demonstrated that a long-term family-based asthma education program resulted in better pulmonary function and QOL of children and parents enrolled in the intervention group, particularly children with non-allergic asthma. PRACTICE IMPLICATIONS Family-based asthma education can reduce the burden of allergic and non-allergic asthma on children and their parents through improving their quality of life. Also, the pulmonary function of children with non-allergic asthma was improved due to My Asthma Therapeutic Education intervention.",2020,The intervention significantly improved quality of life scores of children and their parents (all p < 0.05).,"['children with non-allergic asthma', 'children with asthma and their parents in Tunisia', 'Farhat Hached University Hospital of Sousse (Tunisia) from May 2018 to September 2019', 'children with asthma and their parents', 'children and parents enrolled in the intervention group, particularly children with non-allergic asthma']","['asthma therapeutic education program', 'family empowerment education', 'long-term family-based asthma education program']","['FEV1/FVC ratio', 'pulmonary function and QOL', 'forced expiratory maneuver', 'quality of life scores', 'pulmonary function and quality of life']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0155880', 'cui_str': 'Intrinsic asthma'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0729314', 'cui_str': 'Education provision'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0679959', 'cui_str': 'Empowerment'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1679754', 'cui_str': 'Asthma education'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0269224,The intervention significantly improved quality of life scores of children and their parents (all p < 0.05).,"[{'ForeName': 'Maha', 'Initials': 'M', 'LastName': 'Dardouri', 'Affiliation': 'Université de Sousse, Faculté de Médecine de Sousse Ibn El Jazzar, Laboratoire de recherche Qualité des soins et management des services de santé maternelle (LR12ES03), Rue Mohamed Karoui, 4002 Sousse, Tunisie. Electronic address: maha.dardouri@famso.u-sousse.tn.'}, {'ForeName': 'Jihene', 'Initials': 'J', 'LastName': 'Sahli', 'Affiliation': 'Université de Sousse, Faculté de Médecine de Sousse Ibn El Jazzar, Laboratoire de recherche Qualité des soins et management des services de santé maternelle (LR12ES03), Rue Mohamed Karoui, 4002 Sousse, Tunisie.'}, {'ForeName': 'Thouraya', 'Initials': 'T', 'LastName': 'Ajmi', 'Affiliation': 'Université de Sousse, Faculté de Médecine de Sousse Ibn El Jazzar, Laboratoire de recherche Qualité des soins et management des services de santé maternelle (LR12ES03), Rue Mohamed Karoui, 4002 Sousse, Tunisie.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Mtiraoui', 'Affiliation': 'Université de Sousse, Faculté de Médecine de Sousse Ibn El Jazzar, Laboratoire de recherche Qualité des soins et management des services de santé maternelle (LR12ES03), Rue Mohamed Karoui, 4002 Sousse, Tunisie.'}, {'ForeName': 'Jihene', 'Initials': 'J', 'LastName': 'Bouguila', 'Affiliation': 'Université de Sousse, Faculté de Médecine de Sousse Ibn El Jazzar, Laboratoire de recherche Qualité des soins et management des services de santé maternelle (LR12ES03), Rue Mohamed Karoui, 4002 Sousse, Tunisie.'}, {'ForeName': 'Chekib', 'Initials': 'C', 'LastName': 'Zedini', 'Affiliation': 'Université de Sousse, Faculté de Médecine de Sousse Ibn El Jazzar, Laboratoire de recherche Qualité des soins et management des services de santé maternelle (LR12ES03), Rue Mohamed Karoui, 4002 Sousse, Tunisie.'}, {'ForeName': 'Manel', 'Initials': 'M', 'LastName': 'Mallouli', 'Affiliation': 'Université de Sousse, Faculté de Médecine de Sousse Ibn El Jazzar, Laboratoire de recherche Qualité des soins et management des services de santé maternelle (LR12ES03), Rue Mohamed Karoui, 4002 Sousse, Tunisie.'}]",Journal of pediatric nursing,['10.1016/j.pedn.2020.04.005'] 2736,32616489,"Impact of a nutritional supplement (Impryl) on male fertility: study protocol of a multicentre, randomised, double-blind, placebo-controlled clinical trial (SUppleMent Male fERtility, SUMMER trial).","INTRODUCTION Infertility is a worldwide problem and about 10%-15% of all couples will be affected by the inability to have children. In approximately 50% of infertile couples, a male factor is involved. Most of the male infertile cases are characterised as 'idiopathic', except for a small percentage of cases which are causative by a genetic aetiology. In the past decade, the role of oxidative stress related to sperm quality has been researched thoroughly and estimated to be the problem in 25%-87% of male infertility cases. Impryl is a nutritional supplement which works on the metabolic system and the regulation of oxidative stress by activating the 1-carbon cycle and therefore recycling of homocysteine. We hypothesise that the nutritional supplement Impryl in men of infertile couples might improve the ongoing pregnancy rate. METHODS AND ANALYSIS We designed a multicentre, randomised, double-blind, placebo-controlled clinical trial. We aimed to include 1200 male adults aged 18-50 years, part of a couple that is diagnosed with infertility. The couple will either start or has already been started with fertility treatment, that is, expectative management (duration of 6 months), intrauterine insemination (IUI) with or without mild ovarian stimulation or ovulation induction, either in vitro fertilisation (IVF) or intracytoplasmic sperm injection (ICSI) treatment. Male participants will be randomised in either the Impryl or the placebo group, with identical appearance of the tablets to be distributed (doses: one tablet each day), for a total duration of maximal 6 months. Patients can start directly with fertility treatment and/or natural conception. The primary outcome is the number of ongoing pregnancies confirmed by ultrasound at ≥10 to 12 weeks, and conceived in the time window between randomisation up to and including month 6 of intervention use. Secondary outcomes are change in semen parameters between baseline and after 3 months of intervention in the IUI/IVF/ICSI group, based on (prewash) total motile sperm count. Furthermore the number of pregnancies conceived in the optimal intervention time window (after full spermatogenesis of 72 days), overall number of pregnancies, time to pregnancy, embryo fertilisation rate in IVF/ICSI, embryo-utilisation rate in IVF/ICSI, number of miscarriages, live birth rate and adverse events are documented within the study period of 15 months. ETHICS AND DISSEMINATION The protocol is approved by the local medical ethical review committee at the Radboud University Medical Centre and by the national Central Committee on Research Involving Human Subjects. Findings will be shared with the academic and medical community, funding and patient organisations in order to contribute to optimisation of medical care and quality of life for patients with infertility. TRIAL REGISTRATION NUMBERS NCT03337360 and NTR6551.",2020,"Secondary outcomes are change in semen parameters between baseline and after 3 months of intervention in the IUI/IVF/ICSI group, based on (prewash) total motile sperm count.","['men of infertile couples', 'male infertile cases', 'patients with infertility', 'Male participants', 'male fertility', '1200 male adults aged 18-50 years, part of a couple that is diagnosed with infertility']","['intrauterine insemination (IUI) with or without mild ovarian stimulation or ovulation induction, either in vitro fertilisation (IVF) or intracytoplasmic sperm injection (ICSI) treatment', 'nutritional supplement (Impryl', 'placebo']","['change in semen parameters', 'overall number of pregnancies, time to pregnancy, embryo fertilisation rate in IVF/ICSI, embryo-utilisation rate in IVF/ICSI, number of miscarriages, live birth rate and adverse events', 'number of ongoing pregnancies confirmed by ultrasound at ≥10 to 12 weeks, and conceived in the time window', 'IUI/IVF/ICSI group, based on (prewash) total motile sperm count']","[{'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0021359', 'cui_str': 'Sterility'}, {'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0015895', 'cui_str': 'Ability to conceive'}, {'cui': 'C4517548', 'cui_str': '1200'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0546824', 'cui_str': 'Intrauterine artificial insemination'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0949385', 'cui_str': 'Ovarian Stimulation'}, {'cui': 'C0029967', 'cui_str': 'Ovulation induction'}, {'cui': 'C0015915', 'cui_str': 'In vitro fertilization'}, {'cui': 'C0455164', 'cui_str': 'IVF - In vitro fertilization with intracytoplasmic sperm injection (ICSI)'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0036563', 'cui_str': 'Plant seeds'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0600457', 'cui_str': 'Gravida'}, {'cui': 'C3494204', 'cui_str': 'Time-to-Pregnancy'}, {'cui': 'C0013935', 'cui_str': 'Embryos'}, {'cui': 'C0015914', 'cui_str': 'Fertilization'}, {'cui': 'C0015915', 'cui_str': 'In vitro fertilization'}, {'cui': 'C0455164', 'cui_str': 'IVF - In vitro fertilization with intracytoplasmic sperm injection (ICSI)'}, {'cui': 'C0429916', 'cui_str': 'Number of miscarriages'}, {'cui': 'C0481667', 'cui_str': 'Live birth'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0033010', 'cui_str': 'Pregnancy confirmed'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0557702', 'cui_str': 'Window'}, {'cui': 'C0546824', 'cui_str': 'Intrauterine artificial insemination'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0577264', 'cui_str': 'Sperm motile'}, {'cui': 'C0439157', 'cui_str': 'counts'}]",1200.0,0.404305,"Secondary outcomes are change in semen parameters between baseline and after 3 months of intervention in the IUI/IVF/ICSI group, based on (prewash) total motile sperm count.","[{'ForeName': 'Roos', 'Initials': 'R', 'LastName': 'Smits', 'Affiliation': 'Obstetrics and Gynaecology, Radboudumc, Nijmegen, The Netherlands roos.smits@radboudumc.nl.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': ""D'Hauwers"", 'Affiliation': 'Urology, Radboudumc, Nijmegen, The Netherlands.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'IntHout', 'Affiliation': 'Radboud Institute for Health Sciences, Radboud University Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'Didi', 'Initials': 'D', 'LastName': 'Braat', 'Affiliation': 'Obstetrics and Gynaecology, Radboudumc, Nijmegen, The Netherlands.'}, {'ForeName': 'Kathrin', 'Initials': 'K', 'LastName': 'Fleischer', 'Affiliation': 'Obstetrics and Gynaecology, Radboudumc, Nijmegen, The Netherlands.'}]",BMJ open,['10.1136/bmjopen-2019-035069'] 2737,32616559,Provider visual attention on a respiratory function monitor during neonatal resuscitation.,"BACKGROUND A respiratory function monitor (RFM) provides real-time positive pressure ventilation feedback. Whether providers use RFM during neonatal resuscitation is unknown. METHODS Ancillary study to the MONITOR(NCT03256578) randomised controlled trial. Neonatal resuscitation leaders at two centres wore eye-tracking glasses, and visual attention (VA) patterns were compared between RFM-visible and RFM-masked groups. RESULTS 14 resuscitations (6 RFM-visible, 8 RFM-masked) were analysed. The median total gaze duration on the RFM was significantly higher with a visible RFM (29% vs 1%, p<0.01), while median total gaze duration on other physical objects was significantly lower with a visible RFM (3% vs 8%, p=0.02). Median total gaze duration on the infant was lower with RFM visible, although not statistically significantly (29% vs 46%, p=0.05). CONCLUSION Providers' VA patterns differed during neonatal resuscitation when the RFM was visible, emphasising the importance of studying the impact of additional delivery room technology on providers' behaviour.",2020,"Median total gaze duration on the infant was lower with RFM visible, although not statistically significantly (29% vs 46%, p=0.05). ",['neonatal resuscitation'],['Provider visual attention'],"['median total gaze duration on other physical objects', 'Median total gaze duration', 'median total gaze duration on the RFM']","[{'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0035273', 'cui_str': 'Resuscitation'}]","[{'cui': 'C0589102', 'cui_str': 'Visual attention'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0553544', 'cui_str': 'Gaze'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0347997', 'cui_str': 'Physical object'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0030695', 'cui_str': 'Monitoring of patient'}]",,0.061549,"Median total gaze duration on the infant was lower with RFM visible, although not statistically significantly (29% vs 46%, p=0.05). ","[{'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Herrick', 'Affiliation': ""Department of Pediatrics, Division of Neonatology, The Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, USA herrickh@email.chop.edu.""}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Weinberg', 'Affiliation': ""Department of Pediatrics, Division of Neonatology, The Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, USA.""}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Cecarelli', 'Affiliation': 'Nursing, University of Pennsylvania, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Claire E', 'Initials': 'CE', 'LastName': 'Fishman', 'Affiliation': 'University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania, USA.'}, {'ForeName': 'Haley', 'Initials': 'H', 'LastName': 'Newman', 'Affiliation': ""Department of Pediatrics, The Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, USA.""}, {'ForeName': 'Maria C', 'Initials': 'MC', 'LastName': 'den Boer', 'Affiliation': 'Neonatology, Leiden University Medical Center, Leiden, Zuid-Holland, The Netherlands.'}, {'ForeName': 'Tessa', 'Initials': 'T', 'LastName': 'Martherus', 'Affiliation': 'Neonatology, Leiden University Medical Center, Leiden, Zuid-Holland, The Netherlands.'}, {'ForeName': 'Trixie A', 'Initials': 'TA', 'LastName': 'Katz', 'Affiliation': 'Neonatology, Amsterdam University Medical Centres, Amsterdam, The Netherlands.'}, {'ForeName': 'Vinay', 'Initials': 'V', 'LastName': 'Nadkarni', 'Affiliation': ""Anesthesiology and Critical Care Medicine, The Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, USA.""}, {'ForeName': 'Arjan B', 'Initials': 'AB', 'LastName': 'Te Pas', 'Affiliation': 'Neonatology, Leiden University Medical Center, Leiden, Zuid-Holland, The Netherlands.'}, {'ForeName': 'Elizabeth E', 'Initials': 'EE', 'LastName': 'Foglia', 'Affiliation': ""Department of Pediatrics, Division of Neonatology, The Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, USA.""}]",Archives of disease in childhood. Fetal and neonatal edition,['10.1136/archdischild-2020-319291'] 2738,32616589,Vitamin C to Pregnant Smokers Persistently Improves Infant Airway Function to 12 Months of Age: A Randomised Trial.,"BACKGROUND Vitamin C (500 mg·day -1 ) supplementation for pregnant smokers has been reported to increase newborn pulmonary function and infant forced expiratory flows (FEFs) at 3 months of age. Its effect on airway function through 12 months of age has not been reported. OBJECTIVE To assess whether vitamin C supplementation to pregnant smokers is associated with a sustained increased airway function in their infants through 12 months of age. METHODS This is a prespecified secondary outcome of a randomised, double-blind, placebo-controlled trial that randomised 251 pregnant smokers between 13 and 23 weeks of gestation: 125 to 500 mg·day -1 vitamin C and 126 to placebo. Smoking cessation counselling was provided. FEFs performed at 3 and 12 months of age were analysed by repeated measures analysis of covariance. RESULTS FEFs were performed in 222 infants at 3 months and 202 infants at 12 months of age. The infants allocated to vitamin C had significantly increased FEFs over the first year of life compared to those allocated to placebo. The overall increased flows were: 40.2 mL·sec -1 for FEF 75 (adjusted 95% CI for difference 6.6 to 73.8; p=0.025); 58.3 mL·sec -1 for FEF 50 (95% CI 10.9 to 105.8; p=0.0081); and 55.1 mL·sec -1 for FEF 25-75 (95% CI, 9.7 to 100.5; p=0.013). CONCLUSIONS In offspring of pregnant smokers randomised to vitamin C versus placebo, vitamin C during pregnancy was associated with a small but significantly increased airway function at 3 and 12 months of age, suggesting a potential shift to a higher airway function trajectory curve. Continued follow-up is underway.",2020,The infants allocated to vitamin C had significantly increased FEFs over the first year of life compared to those allocated to placebo.,"['Pregnant Smokers', 'pregnant smokers', '222 infants at 3\u2005months and 202 infants at 12\u2005months of age', '251 pregnant smokers between 13 and 23\u2005weeks of gestation: 125 to 500\u2005mg·day -1 vitamin C and 126 to']","['Vitamin C (500\u2005mg·day -1 ) supplementation', 'Vitamin C', 'vitamin C versus placebo, vitamin C', 'vitamin C', 'vitamin C supplementation', 'placebo']","['newborn pulmonary function and infant forced expiratory flows (FEFs', 'FEFs', 'airway function']","[{'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0761050', 'cui_str': '(GVGVP)251'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C4319551', 'cui_str': '125'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C0470256', 'cui_str': '126'}]","[{'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C4524018', 'cui_str': 'Vitamin C supplementation'}]","[{'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0231921', 'cui_str': 'Pulmonary function'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C3804964', 'cui_str': 'Forced expiratory flow'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}, {'cui': 'C0031843', 'cui_str': 'PH'}]",251.0,0.569629,The infants allocated to vitamin C had significantly increased FEFs over the first year of life compared to those allocated to placebo.,"[{'ForeName': 'Cindy T', 'Initials': 'CT', 'LastName': 'McEvoy', 'Affiliation': 'Department of Pediatrics, Oregon Health & Science University, Portland, OR, USA mcevoyc@ohsu.edu.'}, {'ForeName': 'Lyndsey E', 'Initials': 'LE', 'LastName': 'Shorey-Kendrick', 'Affiliation': 'Division of Neuroscience, Oregon National Primate Research Center, Beaverton, OR, USA.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Milner', 'Affiliation': 'Department of Pediatrics, Oregon Health & Science University, Portland, OR, USA.'}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Schilling', 'Affiliation': 'Department of Pediatrics, Oregon Health & Science University, Portland, OR, USA.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Tiller', 'Affiliation': 'Department of Pediatrics, Indiana University School of Medicine, Indianapolis, IN, USA.'}, {'ForeName': 'Brittany', 'Initials': 'B', 'LastName': 'Vuylsteke', 'Affiliation': 'Department of Pediatrics, Oregon Health & Science University, Portland, OR, USA.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Scherman', 'Affiliation': 'Department of Pediatrics, Oregon Health & Science University, Portland, OR, USA.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Jackson', 'Affiliation': 'PeaceHealth Southwest Medical Center, Vancouver, WA, USA.'}, {'ForeName': 'David M', 'Initials': 'DM', 'LastName': 'Haas', 'Affiliation': 'Department of Obstetrics and Gynecology, Indiana University School of Medicine, Indianapolis, IN, USA.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Harris', 'Affiliation': 'Department of Pediatrics, Oregon Health & Science University, Portland, OR, USA.'}, {'ForeName': 'Byung S', 'Initials': 'BS', 'LastName': 'Park', 'Affiliation': 'Oregon Health & Science University-Portland State University, School of Public Health and Knight Cancer Institute, Portland, OR, USA.'}, {'ForeName': 'Annette', 'Initials': 'A', 'LastName': 'Vu', 'Affiliation': 'Department of Medical Informatics and Clinical Epidemiology, Oregon Health & Science University, Portland, OR, USA.'}, {'ForeName': 'Dale F', 'Initials': 'DF', 'LastName': 'Kraemer', 'Affiliation': 'Department of Medical Informatics and Clinical Epidemiology, Oregon Health & Science University, Portland, OR, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Gonzales', 'Affiliation': 'Division of Pulmonary & Critical Care Medicine, Oregon Health & Science University, Portland, OR, USA.'}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Bunten', 'Affiliation': 'Vancouver Clinic, Vancouver, WA, USA.'}, {'ForeName': 'Eliot R', 'Initials': 'ER', 'LastName': 'Spindel', 'Affiliation': 'Division of Neuroscience, Oregon National Primate Research Center, Beaverton, OR, USA.'}, {'ForeName': 'Cynthia D', 'Initials': 'CD', 'LastName': 'Morris', 'Affiliation': 'Department of Medical Informatics and Clinical Epidemiology, Oregon Health & Science University, Portland, OR, USA.'}, {'ForeName': 'Robert S', 'Initials': 'RS', 'LastName': 'Tepper', 'Affiliation': 'Department of Pediatrics, Indiana University School of Medicine, Indianapolis, IN, USA.'}]",The European respiratory journal,['10.1183/13993003.02208-2019'] 2739,32616595,SABRTOOTH: A randomised controlled feasibility study of Stereotactic Ablative Radiotherapy (SABR) with surgery in paTients with peripheral stage I nOn-small cell lung cancer (NSCLC) cOnsidered To be at Higher risk of complications from surgical resection.,"OBJECTIVES Stereotactic Ablative Radiotherapy (SABR) is a well-established treatment for medically inoperable peripheral stage I non-small cell lung cancer (NSCLC). Previous non-randomised evidence supports SABR as an alternative to surgery, but high quality randomised controlled trial (RCT) evidence is lacking. The SABRTooth study aimed to establish whether a UK phase III RCT was feasible. DESIGN AND METHODS SABRTooth was a UK multi-centre, randomised controlled feasibility study targeting patients with peripheral stage I NSCLC considered to be at higher-risk of surgical complications. Fifty-four patients were planned to be randomised 1:1 to SABR or surgery. The primary outcome was monthly average recruitment rates. RESULTS Between July 2015 and January 2017, 318 patients were considered for the study and 205(64.5%) were deemed ineligible. Of 106 assessed as eligible (33.3%), 24 patients (22.6%) were randomised to SABR (n=14) or surgery (n=10). A key theme for non-participation was treatment preference with 43 (41%) preferring non-surgical treatment and 19(18%) preferring surgery. The average monthly recruitment rate was 1.7 patients against a target of 3. Fifteen patients underwent their allocated treatment, 12 SABR, 3 surgery. CONCLUSIONS We conclude that a phase III RCT randomising higher-risk patients between SABR and surgery is not feasible in the National Health Service (NHS). Patients have pre-existing treatment preferences, which was a barrier to recruitment. A significant proportion of patients randomised to the surgical group declined and chose SABR. SABR remains an alternative to surgery and novel study approaches are needed to define which patients benefit from a non-surgical approach.",2020,A key theme for non-participation was treatment preference with 43 (41%) preferring non-surgical treatment and 19(18%) preferring surgery.,"['medically inoperable peripheral stage I non-small cell lung cancer (NSCLC', 'Of 106 assessed as eligible (33.3%), 24 patients (22.6%) were randomised to SABR (n=14) or surgery (n=10', 'patients with peripheral stage I NSCLC considered to be at higher-risk of surgical complications', 'SABRTooth was a UK multi-centre', 'Between July 2015 and January 2017, 318 patients were considered for the study and 205(64.5%) were deemed ineligible', 'paTients with peripheral stage I nOn-small cell lung cancer (NSCLC', 'Fifteen patients underwent their allocated treatment, 12 SABR, 3 surgery']",['Stereotactic Ablative Radiotherapy (SABR'],['monthly average recruitment rates'],"[{'cui': 'C0205187', 'cui_str': 'Inoperable'}, {'cui': 'C0205100', 'cui_str': 'Peripheral'}, {'cui': 'C0278504', 'cui_str': 'Non-small cell lung cancer stage I'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C4517716', 'cui_str': '33.3'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0729296', 'cui_str': 'Stereotactic'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C1278569', 'cui_str': 'WAS A'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0729296', 'cui_str': 'Stereotactic'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}]","[{'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}]",318.0,0.306544,A key theme for non-participation was treatment preference with 43 (41%) preferring non-surgical treatment and 19(18%) preferring surgery.,"[{'ForeName': 'Kevin N', 'Initials': 'KN', 'LastName': 'Franks', 'Affiliation': ""Leeds Cancer Centre, St James's University Hospital, Leeds, United Kingdom kevin.franks@nhs.net.""}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'McParland', 'Affiliation': 'Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, United Kingdom.'}, {'ForeName': 'Joanne', 'Initials': 'J', 'LastName': 'Webster', 'Affiliation': 'Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, United Kingdom.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Baldwin', 'Affiliation': 'Nottingham University Hospitals, Nottingham, United Kingdom.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Sebag-Montefiore', 'Affiliation': ""Leeds Cancer Centre, St James's University Hospital, Leeds, United Kingdom.""}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Evison', 'Affiliation': 'Manchester University Hospitals NHS Foundation Trust & University of Manchester, Manchester, United Kingdom.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Booton', 'Affiliation': 'Manchester University Hospitals NHS Foundation Trust & University of Manchester, Manchester, United Kingdom.'}, {'ForeName': 'Corinne', 'Initials': 'C', 'LastName': 'Faivre-Finn', 'Affiliation': 'University of Manchester and The Christie NHS Foundation Trust, Manchester, United Kingdom.'}, {'ForeName': 'Babu', 'Initials': 'B', 'LastName': 'Naidu', 'Affiliation': 'Institute of Inflammation and Ageing, College of Medical and Dental Sciences, University of Birmingham, Birmingham, United Kingdom.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Ferguson', 'Affiliation': 'The James Cook University Hospital, Middlesbrough, United Kingdom.'}, {'ForeName': 'Clive', 'Initials': 'C', 'LastName': 'Peedell', 'Affiliation': 'The James Cook University Hospital, Middlesbrough, United Kingdom.'}, {'ForeName': 'Matthew E J', 'Initials': 'MEJ', 'LastName': 'Callister', 'Affiliation': 'Department of Respiratory Medicine, Leeds Teaching Hospitals, Leeds, United Kingdom.'}, {'ForeName': 'Martyn', 'Initials': 'M', 'LastName': 'Kennedy', 'Affiliation': 'Department of Respiratory Medicine, Leeds Teaching Hospitals, Leeds, United Kingdom.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Hewison', 'Affiliation': 'Leeds Institute of Health Sciences, University of Leeds, Leeds, United Kingdom.'}, {'ForeName': 'Janine', 'Initials': 'J', 'LastName': 'Bestall', 'Affiliation': 'Leeds Institute of Health Sciences, University of Leeds, Leeds, United Kingdom.'}, {'ForeName': 'Walter M', 'Initials': 'WM', 'LastName': 'Gregory', 'Affiliation': 'Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, United Kingdom.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Hall', 'Affiliation': 'Western General Hospital, University of Edinburgh, Edinburgh, United Kingdom.'}, {'ForeName': 'Fiona', 'Initials': 'F', 'LastName': 'Collinson', 'Affiliation': 'Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, United Kingdom.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Olivier', 'Affiliation': 'Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, United Kingdom.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Naylor', 'Affiliation': 'Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, United Kingdom.'}, {'ForeName': 'Sue', 'Initials': 'S', 'LastName': 'Bell', 'Affiliation': 'Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, United Kingdom.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Allen', 'Affiliation': 'Patient and Public Involvement Representative, Leeds, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Sloss', 'Affiliation': 'Patient and Public Involvement Representative, Leeds, UK.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Snee', 'Affiliation': ""Leeds Cancer Centre, St James's University Hospital, Leeds, United Kingdom.""}]",The European respiratory journal,['10.1183/13993003.00118-2020'] 2740,32616612,Randomized Double-Blind Clinical Trial Comparing Ultra Rapid Lispro With Lispro in a Basal-Bolus Regimen in Patients With Type 2 Diabetes: PRONTO-T2D.,"OBJECTIVE To evaluate the efficacy and safety of ultra rapid lispro (URLi) versus lispro in patients with type 2 diabetes on a basal-bolus insulin regimen. RESEARCH DESIGN AND METHODS This was a phase 3, treat-to-target, double-blind 26-week study. After an 8-week lead-in to optimize basal insulin glargine or degludec in combination with prandial lispro treatment, patients were randomized to blinded URLi ( n = 336) or lispro ( n = 337) injected 0-2 min prior to meals. Patients could continue metformin and/or a sodium-glucose cotransporter 2 inhibitor. The primary end point was change in HbA 1c from baseline to 26 weeks (noninferiority margin 0.4%), with multiplicity-adjusted objectives for postprandial glucose (PPG) excursions during a standardized meal test. RESULTS HbA 1c improved for both URLi and lispro, and noninferiority was confirmed: estimated treatment difference (ETD) 0.06% (95% CI -0.05; 0.16). Mean change in HbA 1c was -0.38% for URLi and -0.43% for lispro, with an end-of-treatment HbA 1c of 6.92% and 6.86%, respectively. URLi was superior to lispro in controlling 1- and 2-h PPG excursions: 1-h ETD, -0.66 mmol/L (95% CI -1.01, -0.30); 2-h ETD, -0.96 mmol/L (-1.41, -0.52). Significantly lower PPG excursions were evident from 0.5 to 4.0 h postmeal with URLi treatment. There were no significant treatment differences in rates of severe or documented hypoglycemia (<3.0 mmol/L). Incidence of overall treatment-emergent adverse events was similar between treatments. CONCLUSIONS URLi compared with lispro in a basal-bolus regimen was confirmed to be noninferior for HbA 1c and superior to lispro for PPG control in patients with type 2 diabetes.",2020,"Mean change in HbA 1c was -0.38% for URLi and -0.43% for lispro, with an end-of-treatment HbA 1c of 6.92% and 6.86%, respectively.","['patients with type 2 diabetes on a basal-bolus insulin regimen', 'patients with type 2 diabetes', 'Patients With Type']","['ultra rapid lispro (URLi) versus lispro', 'basal insulin glargine or degludec in combination with prandial lispro treatment', 'metformin and/or a sodium-glucose cotransporter 2 inhibitor', 'Ultra Rapid Lispro With Lispro', 'lispro ( n = 337) injected 0-2 min prior to meals', 'blinded URLi']","['HbA 1c improved for both URLi and lispro, and noninferiority', 'Mean change in HbA 1c', 'change in HbA 1c', 'PPG excursions', 'Incidence of overall treatment-emergent adverse events', 'postprandial glucose (PPG) excursions', 'rates of severe or documented hypoglycemia']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}]","[{'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0293359', 'cui_str': 'Insulin Lispro'}, {'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C3491971', 'cui_str': 'insulin degludec'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0017739', 'cui_str': 'Glucose-Sodium Transport System'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C1720154', 'cui_str': 'Inject'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C1998602', 'cui_str': 'Meals'}]","[{'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0293359', 'cui_str': 'Insulin Lispro'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0049716', 'cui_str': ""6-thioguanosine 5'-diphosphate""}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}]",337.0,0.148655,"Mean change in HbA 1c was -0.38% for URLi and -0.43% for lispro, with an end-of-treatment HbA 1c of 6.92% and 6.86%, respectively.","[{'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Blevins', 'Affiliation': 'Texas Diabetes & Endocrinology, Austin, TX.'}, {'ForeName': 'Qianyi', 'Initials': 'Q', 'LastName': 'Zhang', 'Affiliation': 'Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN.'}, {'ForeName': 'Juan P', 'Initials': 'JP', 'LastName': 'Frias', 'Affiliation': 'National Research Institute, Los Angeles, CA.'}, {'ForeName': 'Hideaki', 'Initials': 'H', 'LastName': 'Jinnouchi', 'Affiliation': 'Jinnouchi Hospital, Kumamoto, Japan.'}, {'ForeName': 'Annette M', 'Initials': 'AM', 'LastName': 'Chang', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Diabetes care,['10.2337/dc19-2550'] 2741,32616866,Controlled blood sugar improves the eye's accommodative ability in type-1 diabetes.,"PURPOSE To evaluate the impact of blood sugar level on ocular measures, including refractive error (RE), amplitude of accommodation (AoA), and lag of accommodation (LoA), in pre-presbyopes with type-1 diabetes. METHOD The fasting blood sugar (FBS) and ocular measures of type-1 diabetes patients (age: 14-39 years; n = 30) on insulin treatment was recorded while they fasted on two separate visits, at baseline and 3 months later. The AoA and LoA was measured with the appropriate spectacle correction worn. The Welch's t-test was used for comparison of the baseline measures between the normal FBS ≤ 7 (n = 10) and higher FBS > 7 (n = 20) patients, and the paired t-test used to investigate for differences between the baseline and follow-up data in patients with changes in FBS. RESULTS On average, the spectacle correction for the normal FBS group was marginally more myopic (RE: -0.30 ± 0.67 D vs. +0.18 ± 1.00 D, p = 0.032), and they showed greater AoA (5.38 ± 1.08 D vs. 3.68 ± 1.43 D, p < 0.001) and lower LoA (1.00 ± 0.30 D vs. 1.30 ± 0.38 D, p = 0.004) compared with the higher FBS group at baseline. On the follow-up visit attended by 25 patients, the FBS of 15 patients was reduced by an average of 7.0 mmol/L, 8 patients had an average increase of 5.2 mmol/L, while 2 patients recorded no changes relative to the baseline. The patients whose FBS was reduced showed improvement in the mean AoA from 3.78 ± 1.58 D to 4.88 ± 1.61 D (p < 0.001) and a reduction in the mean LoA from 1.37 ± 0.40D to 0.87 ± 0.19D (p < 0.001), whereas those with deteriorated control of the FBS showed an opposite trend. CONCLUSIONS Controlling hyperglycemia improves ocular accommodation in type-1 diabetes.",2020,"D vs. 3.68 ± 1.43 D, p < 0.001) and lower LoA (1.00 ± 0.30 D vs. 1.30 ± 0.38 D, p = 0.004) compared with the higher FBS group at baseline.","['type-1 diabetes', 'type-1 diabetes patients (age: 14-39 years; n\u2009=\u200930) on']","['Controlled blood sugar', 'Controlling hyperglycemia', 'insulin treatment']","['ocular accommodation', 'fasting blood sugar (FBS) and ocular measures', 'refractive error (RE), amplitude of accommodation (AoA), and lag of accommodation (LoA), in pre-presbyopes with type-1 diabetes']","[{'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0011854', 'cui_str': 'Type 1 diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0034951', 'cui_str': 'Disorder of refraction'}, {'cui': 'C1627880', 'cui_str': 'Accommodative amplitude'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]",,0.0327062,"D vs. 3.68 ± 1.43 D, p < 0.001) and lower LoA (1.00 ± 0.30 D vs. 1.30 ± 0.38 D, p = 0.004) compared with the higher FBS group at baseline.","[{'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Abokyi', 'Affiliation': 'Department of Optometry and Vision Science, School of Allied Health Sciences, College of Health and Allied Sciences, University of Cape Coast, Cape Coast, Ghana. sabokyi@ucc.edu.gh.'}, {'ForeName': 'Patience Ansomah', 'Initials': 'PA', 'LastName': 'Ayerakwah', 'Affiliation': 'Department of Optometry and Vision Science, School of Allied Health Sciences, College of Health and Allied Sciences, University of Cape Coast, Cape Coast, Ghana.'}, {'ForeName': 'Sampson Listowell', 'Initials': 'SL', 'LastName': 'Abu', 'Affiliation': 'Department of Ophthalmology and Visual Sciences, The University of Alabama at Birmingham, Birmingham, AL, USA.'}, {'ForeName': 'Emmanuel Kwasi', 'Initials': 'EK', 'LastName': 'Abu', 'Affiliation': 'Department of Optometry and Vision Science, School of Allied Health Sciences, College of Health and Allied Sciences, University of Cape Coast, Cape Coast, Ghana.'}]","Eye (London, England)",['10.1038/s41433-020-1058-y'] 2742,32616867,Microperimetry and mfERG as functional measurements in diabetic macular oedema undergoing intravitreal ranibizumab treatment.,"PURPOSE To evaluate Microperimetry (MP) and multifocal electroretinogram (mfERG) as whole-macula functional markers of treatment response in naive diabetic macular oedema (DMO) patients undergoing ranibizumab treatment. METHODS An exploratory sub-analysis of a prospective study (NCT01947881-CHARTRES). Patients received three monthly ranibizumab injections (loading dose) followed by pro re nata (PRN) regimen during 1 year. At baseline, during and after treatment (Months 0, 3, 6 and 12), subjects were tested using BCVA, OCT, MP and mfERG. MP was performed in the central 12°, and retinal sensitivity was measured overall (mean sensitivity (MS)), and in three concentric rings (R1-R3). mfERG P1 amplitude and implicit time were measured over six concentric rings (R1-R6). RESULTS Thirty-two eyes were included. MP mean and rings sensitivity were significantly lower in DMO (p < 0.001). After loading dose, a significant improvement in retina sensitivity was observed, particularly in good BCVA responders (MS = +2.28 dB; R1 = +2.33 dB, R2 = +2.20 dB, R3 = +2.25 dB; p = 0.049). Overall retinal sensitivity was significantly correlated with BCVA improvement (r = 0.54; p = 0.026) and inversely correlated with OCT central subfield thickness improvement (r = -0.39; p = 0.026). mfERG amplitude and implicit time were also lower in DMO (p < 0.011). An improvement of mfERG P1 amplitude and implicit time in R1 was noted in good responders after ranibizumab loading dose (+16.49 nV/deg 2 ; p = 0.013 and -0.005 ms; p = 0.048, respectively). When changing to PRN treatment regimen, BCVA was maintained during the 12 months of follow-up but worsening of the visual function was detected by MP and mfERG. CONCLUSIONS Microperimetry and mfERG were able to demonstrate DMO functional improvement after treatment loading dose, as well as early visual changes when treatment regimen was switched to PRN.",2020,"An improvement of mfERG P1 amplitude and implicit time in R1 was noted in good responders after ranibizumab loading dose (+16.49 nV/deg 2 ; p = 0.013 and -0.005 ms; p = 0.048, respectively).","['naive diabetic macular oedema (DMO) patients undergoing ranibizumab treatment', 'Thirty-two eyes were included', 'diabetic macular oedema undergoing intravitreal ranibizumab treatment']","['Microperimetry and mfERG', 'ranibizumab injections (loading dose) followed by pro re nata (PRN', 'Microperimetry (MP) and multifocal electroretinogram (mfERG']","['DMO functional improvement', 'OCT central subfield thickness improvement (r', 'BCVA improvement', 'MP mean and rings sensitivity', 'retina sensitivity', 'mfERG P1 amplitude and implicit time in R1', 'mfERG amplitude and implicit time', 'Overall retinal sensitivity', 'visual function', 'mfERG P1 amplitude and implicit time']","[{'cui': 'C0730285', 'cui_str': 'Macular edema due to diabetes mellitus'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1566537', 'cui_str': 'ranibizumab'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0450357', 'cui_str': '32'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1517572', 'cui_str': 'Intravitreal route'}]","[{'cui': 'C0205292', 'cui_str': 'Multifocal'}, {'cui': 'C0013867', 'cui_str': 'Electroretinography'}, {'cui': 'C4050112', 'cui_str': 'ranibizumab Injection'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C0067792', 'cui_str': 'N-acetyltryptophanamide'}]","[{'cui': 'C0730285', 'cui_str': 'Macular edema due to diabetes mellitus'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0029279', 'cui_str': 'Ornithine carbamoyltransferase'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0521164', 'cui_str': 'Annular shape'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0035298', 'cui_str': 'Retinal structure'}, {'cui': 'C0205292', 'cui_str': 'Multifocal'}, {'cui': 'C0013867', 'cui_str': 'Electroretinography'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}]",32.0,0.0259257,"An improvement of mfERG P1 amplitude and implicit time in R1 was noted in good responders after ranibizumab loading dose (+16.49 nV/deg 2 ; p = 0.013 and -0.005 ms; p = 0.048, respectively).","[{'ForeName': 'Ana Rita', 'Initials': 'AR', 'LastName': 'Santos', 'Affiliation': 'Association for Innovation and Biomedical Research on Light, Coimbra, Portugal. asantos@aibili.pt.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Raimundo', 'Affiliation': 'Department of Ophthalmology, Centro Hospitalar e Universitário de Coimbra (CHUC), Coimbra, Portugal.'}, {'ForeName': 'Dalila', 'Initials': 'D', 'LastName': 'Alves', 'Affiliation': 'Association for Innovation and Biomedical Research on Light, Coimbra, Portugal.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Lopes', 'Affiliation': 'Association for Innovation and Biomedical Research on Light, Coimbra, Portugal.'}, {'ForeName': 'Sérgio', 'Initials': 'S', 'LastName': 'Pestana', 'Affiliation': 'Faculty of Medicine, University of Coimbra, Coimbra, Portugal.'}, {'ForeName': 'João', 'Initials': 'J', 'LastName': 'Figueira', 'Affiliation': 'Association for Innovation and Biomedical Research on Light, Coimbra, Portugal.'}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Cunha-Vaz', 'Affiliation': 'Association for Innovation and Biomedical Research on Light, Coimbra, Portugal.'}, {'ForeName': 'Rufino', 'Initials': 'R', 'LastName': 'Silva', 'Affiliation': 'Association for Innovation and Biomedical Research on Light, Coimbra, Portugal.'}]","Eye (London, England)",['10.1038/s41433-020-1054-2'] 2743,32616883,Exercise intervention lowers aberrant serum WISP-1 levels with insulin resistance in breast cancer survivors: a randomized controlled trial.,"Insulin resistance is associated with increased risk for and recurrence of breast cancer. Recently, Wnt1-inducible signaling pathway protein-1 (WISP-1) was reported to impair glucose metabolism and insulin sensitivity. In various cancer tissues, Wnt signaling is upregulated and induces further oncogenic and metastatic activity. However, the effects of exercise on serum levels of WISP-1 and its upstream β-catenin have not been studied in cancer patients. We investigated the effects of exercise training on Wnt signaling and insulin sensitivity in breast cancer survivors (BCS). This single-center trial randomized 46 BCS into either 12-week exercise or control groups (1:1), and included an additional 12 age-matched healthy women. Kinanthropometric parameters, serum Wnt signaling markers, and gluco-lipid profiles were evaluated before and after the intervention. Serum β-catenin and WISP-1 concentrations were significantly higher in BCS than in healthy subjects. There was a positive correlation between β-catenin and WISP-1 levels. Exercise training in BCS significantly reduced body fat and waist circumference and enhanced aerobic and muscular fitness. Exercise decreased β-catenin and WISP-1 levels and improved gluco-lipid profiles. There was a notable correlation between changes in HOMA-IR indexes and serum WISP-1, but not with β-catenin during the exercise intervention. In conclusion, a 12-week community-based exercise intervention resulted in significant reductions in serum β-catenin and WISP-1 levels, accompanied by favorable improvements in body composition, physical fitness, and biochemical parameters in BCS. We also highlight that this is the first report concerning effects of exercise on circulating β-catenin and WISP-1 levels and correlations between WISP-1 and insulin sensitivity, which could be important for determining prognoses for BCS.",2020,Serum β-catenin and WISP-1 concentrations were significantly higher in BCS than in healthy subjects.,"['12 age-matched healthy women', 'breast cancer survivors', 'breast cancer survivors (BCS', 'cancer patients']","['exercise training', 'Exercise intervention', 'Exercise training', 'community-based exercise intervention']","['body composition, physical fitness, and biochemical parameters in BCS', 'Kinanthropometric parameters, serum Wnt signaling markers, and gluco-lipid profiles', 'Serum β-catenin and WISP-1 concentrations', 'body fat and waist circumference and enhanced aerobic and muscular fitness', 'HOMA-IR indexes and serum WISP-1', 'β-catenin and WISP-1 levels and improved gluco-lipid profiles', 'serum β-catenin and WISP-1 levels', 'β-catenin and WISP-1 levels']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C1564904', 'cui_str': 'Catenin Proteins'}, {'cui': 'C1449212', 'cui_str': 'WISP1 protein, human'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0455829', 'cui_str': 'Waist circumference'}, {'cui': 'C0442025', 'cui_str': 'Muscular'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",46.0,0.0220849,Serum β-catenin and WISP-1 concentrations were significantly higher in BCS than in healthy subjects.,"[{'ForeName': 'Jae Seung', 'Initials': 'JS', 'LastName': 'Chang', 'Affiliation': 'Mitohormesis Research Center, Wonju College of Medicine, Yonsei University, Wonju, Korea.'}, {'ForeName': 'Tae Ho', 'Initials': 'TH', 'LastName': 'Kim', 'Affiliation': 'Department of Physiology, Wonju College of Medicine, Yonsei University, Wonju, Korea.'}, {'ForeName': 'In Deok', 'Initials': 'ID', 'LastName': 'Kong', 'Affiliation': 'Department of Physiology, Wonju College of Medicine, Yonsei University, Wonju, Korea. kong@yonsei.ac.kr.'}]",Scientific reports,['10.1038/s41598-020-67794-w'] 2744,32616985,A Comparison between Oblique and Vertical Incisions on the Hamstring Tendon Harvesting in Anterior Cruciate Ligament Reconstruction and Infrapatellar Branch Injury of the Saphenous Nerve.,"Objective  The present study aimed to compare the oblique and vertical incisions in hamstring tendon harvesting in anterior cruciate ligament (ACL) reconstruction and in infrapatellar branch injury of the saphenous nerve. Methods  The present study was conducted at a tertiary referral center for 12 months. Patients with an indication of reconstruction of ACL tear were included in the study, who were then randomized into two groups (vertical [VG] and oblique [OG] groups). After excluding a few cases, 92 patients were eligible for further analysis (VG: n= 44; OG: n =  48). They were followed-up for 9 months after the surgery, and loss of sensation over the knee and over the proximal aspect of the operated leg was recorded. Results  The mean lengths of the incisions were 27 mm and 38 mm for the OG and VG groups, respectively. The total rate of hypoesthesia was 40% (27 patients). A total of 12 (25%) and 25 patients (56.8%) on the OG and VG groups, respectively, reported hypoesthesia symptoms. The presence of hypoesthesia in patients in the VG group was two times higher than in the OG group. No statistical correlation was observed between the nerve injury and age, gender, education, and delay from injury to reconstruction. Conclusion  Oblique incision, which showed lower risk of nerve damage, might be more recommended for graft harvesting. Patients who underwent reconstruction of the ACL in the OG group had a lower incidence of peri-incisional hypoesthesia when compared to those in the VG group.",2020,Patients who underwent reconstruction of the ACL in the OG group had a lower incidence of peri-incisional hypoesthesia when compared to those in the VG group.,"['Patients with an indication of reconstruction of ACL tear', '92 patients were eligible for further analysis (VG: n= 44; OG: n\u2009= \u200948', 'Anterior Cruciate Ligament Reconstruction and Infrapatellar Branch Injury of the Saphenous Nerve']","['Oblique and Vertical Incisions', 'hamstring tendon harvesting in anterior cruciate ligament (ACL) reconstruction', 'oblique and vertical incisions']","['presence of hypoesthesia', 'peri-incisional hypoesthesia', 'mean lengths of the incisions', 'hypoesthesia symptoms', 'total rate of hypoesthesia']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0392360', 'cui_str': 'Indication of'}, {'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}, {'cui': 'C0409312', 'cui_str': 'Rupture of anterior cruciate ligament'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C3178820', 'cui_str': 'Anterior Cruciate Ligament Reconstruction'}, {'cui': 'C0205384', 'cui_str': 'Branching'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0228919', 'cui_str': 'Structure of saphenous nerve'}]","[{'cui': 'C0205315', 'cui_str': 'Oblique'}, {'cui': 'C0205128', 'cui_str': 'Vertical'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0039508', 'cui_str': 'Tendon structure'}, {'cui': 'C3178820', 'cui_str': 'Anterior Cruciate Ligament Reconstruction'}]","[{'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0020580', 'cui_str': 'Hypesthesia'}, {'cui': 'C0347985', 'cui_str': 'During values'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",92.0,0.0250774,Patients who underwent reconstruction of the ACL in the OG group had a lower incidence of peri-incisional hypoesthesia when compared to those in the VG group.,"[{'ForeName': 'Sohrab', 'Initials': 'S', 'LastName': 'Keyhani', 'Affiliation': 'Departamento Ortopédico, Shahid Beheshti University of Medical Sciences, Akhtar Hospital, Tehran, Iran.'}, {'ForeName': 'Seyyed Morteza', 'Initials': 'SM', 'LastName': 'Kazemi', 'Affiliation': 'Departamento Ortopédico, Shahid Beheshti University of Medical Sciences, Akhtar Hospital, Tehran, Iran.'}, {'ForeName': 'Mohammadreza Minator', 'Initials': 'MM', 'LastName': 'Sajjadi', 'Affiliation': 'Departamento Ortopédico, Shahid Beheshti University of Medical Sciences, Taleghani Hospital, Tehran, Iran.'}, {'ForeName': 'Asghar', 'Initials': 'A', 'LastName': 'Elmi', 'Affiliation': 'Departamento Ortopédico, Shahid Beheshti University of Medical Sciences, Akhtar Hospital, Tehran, Iran.'}]",Revista brasileira de ortopedia,['10.1055/s-0039-1692695'] 2745,32616998,Defocus Curve and Patient Satisfaction with a New Extended Depth of Focus Toric Intraocular Lens Targeted for Binocular Emmetropia or Slight Myopia in the Non-Dominant Eye.,"Purpose To evaluate the defocus curve and patient satisfaction after implantation of an extended depth of focus (EDOF) toric IOL when both eyes were targeted for emmetropia and when the non-dominant eye was targeted for mini monovision (-0.50D). Methods A prospective unmasked randomized clinical trial in three clinical practices in the USA. Subjects presenting for routine cataract surgery were assigned to one of two groups, both receiving bilateral toric EDOF lenses. One group had the non-dominant eye targeted for slight myopia (-0.50D). Measures of interest were the postoperative defocus curve and reported patient satisfaction and visual disturbances. Results Questionnaire and defocus curve data were available from 37 subjects in the Emmetropia group, while the mini monovision group included questionnaire data from 39 subjects and valid defocus curve data from 14 subjects. Mini monovision subjects had significantly better VA (a half line to a line better, p < 0.05), from a defocus of -1.50 D to -3.00 D. Reported spectacle wear and satisfaction were not significantly different between groups at any distance, but more patients in the mini monovision group reported the ability to function comfortably without glasses at near and overall (near p = 0.02, overall p < 0.01). Halos and starbursts were the two phenomena reported most often for both groups, with reported starbursts slightly more common in the mini monovision group. Conclusions A slightly myopic correction in the non-dominant eye improved binocular near vision by 0.5 to 1.0 lines based on defocus curve data. Patients reported better functional vision, but with a slight increase in reported starbursts in the mini monovision group.",2020,"Mini monovision subjects had significantly better VA (a half line to a line better, p < 0.05), from a defocus of -1.50 D to -3.00",['Subjects presenting for routine cataract surgery'],['bilateral toric EDOF lenses'],"['functional vision', 'patient satisfaction and visual disturbances', 'binocular near vision', 'spectacle wear and satisfaction']","[{'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0007389', 'cui_str': 'Extraction of cataract'}]","[{'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0023317', 'cui_str': 'Lens clear'}]","[{'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0042789', 'cui_str': 'Visual function'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0547030', 'cui_str': 'Visual disturbance'}, {'cui': 'C2594855', 'cui_str': 'Binoculars'}, {'cui': 'C0027092', 'cui_str': 'Myopia'}, {'cui': 'C0015421', 'cui_str': 'Eyeglasses'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",39.0,0.0639064,"Mini monovision subjects had significantly better VA (a half line to a line better, p < 0.05), from a defocus of -1.50 D to -3.00","[{'ForeName': 'Helga P', 'Initials': 'HP', 'LastName': 'Sandoval', 'Affiliation': 'Carolina Eyecare Physicians, LLC, Mt. Pleasant, SC, USA.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Lane', 'Affiliation': 'Associated Eye Care, Stillwater, MN, USA.'}, {'ForeName': 'Stephen G', 'Initials': 'SG', 'LastName': 'Slade', 'Affiliation': 'Slade & Baker Vision, Houston, TX, USA.'}, {'ForeName': 'Eric D', 'Initials': 'ED', 'LastName': 'Donnenfeld', 'Affiliation': 'Ophthalmic Consultants of Long Island, Long Island, NY, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Potvin', 'Affiliation': 'Science in Vision, Akron, NY, USA.'}, {'ForeName': 'Kerry D', 'Initials': 'KD', 'LastName': 'Solomon', 'Affiliation': 'Carolina Eyecare Physicians, LLC, Mt. Pleasant, SC, USA.'}]","Clinical ophthalmology (Auckland, N.Z.)",['10.2147/OPTH.S247333'] 2746,32617000,Vestibular Rehabilitation Using Posturographic System in Elderly Patients with Postural Instability: Can the Number of Sessions Be Reduced?,"Purpose Vestibular rehabilitation (VR) using posturography systems has proved useful in improving balance among elderly patients with postural instability. However, its high cost hinders its use. The objective of this study is to assess whether two different protocols of VR with posturography, one of them longer (ten sessions) and the other shorter (five sessions), show significant differences in the improvement of balance among old patients with instability. Patients and Methods This is a prospective, experimental, single-center (Department of Otorhinolaryngology of a tertiary referral hospital), randomized (into balanced patient blocks) study with two parallel arms, in 40 people over 65 years of age, with instability and at a high risk of falling. The percentage of the average balance (composite) in the sensory organization test (SOT) of the CDP (main outcome measure), other CDP scores, time and steps in the ""timed up and go"" test, scores of Dizziness Handicap Inventory (DHI), short Falls Efficacy Scale - International (short FES-I), and Vertiguard were compared before and 3 weeks after VR between both intervention groups. Results The two treatment groups (20 patients per group) were comparable in age, sex, and pre-VR balance evaluation. In both groups, we observed a significant improvement in global balance (composite) after VR (49±11.34 vs 57±13.48, p=0.007, in the group undergoing 10 sessions; 51±12.55 vs 60±12.99, p=0.002, 5 sessions). In both groups, we also observed improvements in other posturographic parameters (in the SOT and limits of stability) but not in the timed up and go scores or in the questionnaires. Comparison of the improvement level achieved in both groups revealed no significant differences between them. Conclusion The protocols of vestibular rehabilitation by posturography of 5 sessions in elderly patients with postural instability are as effective as those of 10 sessions for improving balance among elderly patients with postural instability. Trial Registration ClinicalTrials.gov identifier: NCT03034655. Registered on 25 January 2017.",2020,"In both groups, we observed a significant improvement in global balance (composite) after VR (49±11.34 vs 57±13.48, p=0.007, in the group undergoing 10 sessions; 51±12.55 vs 60±12.99, p=0.002, 5 sessions).","['single-center (Department of Otorhinolaryngology of a tertiary referral hospital', 'old patients with instability', 'elderly patients with postural instability', 'Elderly Patients with Postural Instability', '40 people over 65 years of age, with instability and at a high risk of falling']","['Vestibular rehabilitation (VR) using posturography systems', 'Vestibular Rehabilitation Using Posturographic System', 'vestibular rehabilitation by posturography of 5 sessions']","['global balance (composite) after VR', 'posturographic parameters', 'CDP scores, time and steps in the ""timed up and go"" test, scores of Dizziness Handicap Inventory (DHI), short Falls Efficacy Scale - International (short FES-I), and Vertiguard']","[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0029892', 'cui_str': 'Otolaryngology'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0085633', 'cui_str': 'Mood swings'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C1843921', 'cui_str': 'Postural instability'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0000921', 'cui_str': 'Accidental fall'}]","[{'cui': 'C0200324', 'cui_str': 'Vestibular rehabilitation'}, {'cui': 'C0919611', 'cui_str': 'Posturography'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0200324', 'cui_str': 'Vestibular rehabilitation'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0008188', 'cui_str': 'Chlordiazepoxide'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0231172', 'cui_str': 'Handicap'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C2919878', 'cui_str': 'Short falls efficacy scale - international'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}]",,0.0168765,"In both groups, we observed a significant improvement in global balance (composite) after VR (49±11.34 vs 57±13.48, p=0.007, in the group undergoing 10 sessions; 51±12.55 vs 60±12.99, p=0.002, 5 sessions).","[{'ForeName': 'Andrés', 'Initials': 'A', 'LastName': 'Soto-Varela', 'Affiliation': 'Division of Neurotology, Department of Otorhinolaryngology, Complexo Hospitalario Universitario, Santiago de Compostela, Spain.'}, {'ForeName': 'Marcos', 'Initials': 'M', 'LastName': 'Rossi-Izquierdo', 'Affiliation': 'Department of Otorhinolaryngology, University Hospital Lucus Augusti, Lugo, Spain.'}, {'ForeName': 'María', 'Initials': 'M', 'LastName': 'Del-Río-Valeiras', 'Affiliation': 'Department of Otorhinolaryngology, Complexo Hospitalario Universitario, Santiago de Compostela, Spain.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Vaamonde-Sánchez-Andrade', 'Affiliation': 'Department of Otorhinolaryngology, Complexo Hospitalario Universitario, Santiago de Compostela, Spain.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Faraldo-García', 'Affiliation': 'Department of Otorhinolaryngology, Complexo Hospitalario Universitario, Santiago de Compostela, Spain.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Lirola-Delgado', 'Affiliation': 'Department of Otorhinolaryngology, Complexo Hospitalario Universitario, Santiago de Compostela, Spain.'}, {'ForeName': 'Sofía', 'Initials': 'S', 'LastName': 'Santos-Pérez', 'Affiliation': 'Division of Neurotology, Department of Otorhinolaryngology, Complexo Hospitalario Universitario, Santiago de Compostela, Spain.'}]",Clinical interventions in aging,['10.2147/CIA.S263302'] 2747,32617006,Erratum: The Differences in Perceptions of Interprofessional Education Among Health Profession Students: The Indonesian Experience [Erratum].,[This corrects the article DOI: 10.2147/JMDH.S240195.].,2020,[This corrects the article DOI: 10.2147/JMDH.S240195.].,"['Health Profession Students', 'Erratum']",[],[],"[{'cui': 'C0018722', 'cui_str': 'Health Professions'}, {'cui': 'C0038492', 'cui_str': 'Student'}]",[],[],,0.015601,[This corrects the article DOI: 10.2147/JMDH.S240195.].,[],Journal of multidisciplinary healthcare,['10.2147/JMDH.S262940'] 2748,32617013,"Effects of MK-7 Supplementation on Glycemic Status, Anthropometric Indices and Lipid Profile in Patients with Type 2 Diabetes: A Randomized Controlled Trial.","Background Type 2 diabetes mellitus (T2DM) is a prevalent disorder which accounts for 90-95% of diabetic patients. The aim of this study was to assess the effects of menaquinone (MK-7) supplementation on glycemic indices, anthropometric indices and lipid profile, among patients with T2DM. Methods In this double-blind placebo-controlled randomized clinical trial, 60 men and women with T2DM were allocated equally into either the MK-7 (200 µg/day) or the placebo group. Physical activity level and dietary intake were assessed using the international physical activity questionnaire-short form (IPAQ-SF) and a 3-day food record, pre- and post-intervention. Anthropometric measures, blood pressure, glycemic indices and lipid profile including fasting blood sugar (FBS), hemoglobin A1c (HBA1C), fasting insulin (FI), homeostatic model assessment insulin resistance index (HOMA-IR), triglycerides (TG), total cholesterol (TC), high-density lipoprotein (HDL-C) and low-density lipoprotein (LDL-C) were measured at baseline and after twelve weeks. Results Forty-five patients completed the trial. There were no significant between-group differences for calorie intake, macronutrient intake, physical activity level or anthropometric measures at baseline and at the end of the study. Dietary vitamin K intake increased significantly at the end of the study in the MK-7 ( p : 0.02) and placebo ( p : 0.001) groups, but intergroup differences were not significant ( p : 0.86). FBS ( p : 0.01), HbA1c (p: 0.002), fasting insulin ( p : 0.01) and HOMA-IR ( p : 0.007) decreased significantly in the MK-7 group. Furthermore, after adjustment for the baseline values and changes of vitamin K intake at the end of study, FBS and HbA1C showed significant intergroup changes, and they were significantly lower in the MK-7 group compared to the placebo group. Lipid profile (TG, TC, LDL-C, HDL-C and LDL-C/HDL-C) did not change significantly within or between groups. Conclusion MK-7 supplementation seems to be effective in the improvement of glycemic indices, but not the lipid profile of patients with T2DM. Clinical Trial Registration The present study was prospectively registered at the Iranian Registry of Clinical Trials on May 2019 (ID: IRCT20100123003140N22).",2020,"There were no significant between-group differences for calorie intake, macronutrient intake, physical activity level or anthropometric measures at baseline and at the end of the study.","['patients with T2DM', '60 men and women with T2DM', 'Results\n\n\nForty-five patients completed the trial', 'Patients with Type 2 Diabetes']","['MK-7 Supplementation', 'MK-7', 'placebo', 'menaquinone (MK-7) supplementation']","['Glycemic Status, Anthropometric Indices and Lipid Profile', 'international physical activity questionnaire-short form (IPAQ-SF', 'vitamin K intake', 'calorie intake, macronutrient intake, physical activity level or anthropometric measures', 'HOMA-IR', 'Anthropometric measures, blood pressure, glycemic indices and lipid profile including fasting blood sugar (FBS), hemoglobin A1c (HBA1C), fasting insulin (FI), homeostatic model assessment insulin resistance index (HOMA-IR), triglycerides (TG), total cholesterol (TC), high-density lipoprotein (HDL-C) and low-density lipoprotein (LDL-C', 'Dietary vitamin K intake', 'Lipid profile (TG, TC, LDL-C, HDL-C and LDL-C/HDL-C', 'glycemic indices', 'fasting insulin', 'FBS', 'Physical activity level and dietary intake', 'glycemic indices, anthropometric indices and lipid profile']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0086605', 'cui_str': 'Vitamin K 2'}]","[{'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C2317598', 'cui_str': 'Vitamin K intake'}, {'cui': 'C0006777', 'cui_str': 'Energy intake'}, {'cui': 'C2346926', 'cui_str': 'Macronutrient'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C1136206', 'cui_str': 'Glycemic Index Number'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0023823', 'cui_str': 'Low density lipoprotein'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C3495427', 'cui_str': 'Fanconi-Bickel Syndrome'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}]",60.0,0.329884,"There were no significant between-group differences for calorie intake, macronutrient intake, physical activity level or anthropometric measures at baseline and at the end of the study.","[{'ForeName': 'Nahid', 'Initials': 'N', 'LastName': 'Karamzad', 'Affiliation': 'Student Research Committee, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Esmaeil', 'Initials': 'E', 'LastName': 'Faraji', 'Affiliation': 'Endocrine Research Center, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Shaghayegh', 'Initials': 'S', 'LastName': 'Adeli', 'Affiliation': 'Department of Biochemistry and Diet Therapy, Faculty of Nutrition and Food Sciences, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Carson-Chahhoud', 'Affiliation': 'Australian Centre for Precision Health, School of Health Sciences, University of South Australia, Adelaide, South Australia, Australia.'}, {'ForeName': 'Samaneh', 'Initials': 'S', 'LastName': 'Azizi', 'Affiliation': 'Department of Biochemistry and Diet Therapy, Faculty of Nutrition and Food Sciences, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Bahram', 'Initials': 'B', 'LastName': 'Pourghassem Gargari', 'Affiliation': 'Department of Biochemistry and Diet Therapy, Faculty of Nutrition and Food Sciences, Tabriz University of Medical Sciences, Tabriz, Iran.'}]","Diabetes, metabolic syndrome and obesity : targets and therapy",['10.2147/DMSO.S253014'] 2749,32617016,Improvement of Pain and Function After Use of a Topical Pain Relieving Patch: Results of the RELIEF Study.,"Purpose Pain is the most common reason for patients to consult primary care providers. Identification of effective treatments with minimal adverse events is critical to safer opioid-sparing and multi-modal approaches to pain treatment. Topical analgesic patches target medication to peripheral sites of pain while potentially avoiding adverse effects associated with systemic medications. Opioids, prescription nonsteroidal anti-inflammatory drugs, and over-the-counter oral medications are associated with systemic toxicities, increasing morbidity and mortality. This study evaluated a topical analgesic pain-relieving patch in reducing pain severity and improving function in patients with mild to moderate arthritic, neurological, or musculoskeletal pain. Patients and Methods This Institutional Review Board-approved study evaluated the effectiveness of a topical pain-relieving patch in reducing Brief Pain Inventory (BPI) scores in patients. The treatment group (TG) (n=152) received patches for 14 days. A control group (CG) (n=47) did not receive the patch. After day 14, 34 CG patients crossed over to treatment (CROSSG) with the patch. Surveys were administered to patients at baseline and 14 days to assess changes in pain severity and interference. Changes in oral pain medication use, side effects, and satisfaction use were also assessed. Results Paired data were collected in the CG, TG and CROSSG. At day 14, TG pain severity score and pain interference score decreased (49% and 58.1%, respectively). Pain severity and interference scores decreased less in the CG (12.3% and 14.8%, respectively). In the study, 60.5% of the TG were using concomitant oral pain medications ""a lot less"", and 90.8% were very/extremely satisfied with the patch. CROSSG patients showed similar reductions in pain severity and interference scores after patch treatment. No side effects of treatment were reported. Conclusion Results indicate that this topical analgesic pain-relieving patch can reduce BPI pain severity and interference scores in adult patients with mild to moderate arthritic, neurological, and musculoskeletal pain and should be considered as a treatment option.",2020,"Pain severity and interference scores decreased less in the CG (12.3% and 14.8%, respectively).","['adult patients with mild to moderate arthritic, neurological, and musculoskeletal pain', 'patients with mild to moderate arthritic, neurological, or musculoskeletal pain', 'patients', 'patients to consult primary care providers']","['Topical Pain Relieving Patch', 'topical pain-relieving patch', 'topical analgesic pain-relieving patch']","['Brief Pain Inventory (BPI) scores', 'BPI pain severity and interference scores', 'Pain severity and interference scores', 'oral pain medication use, side effects, and satisfaction use', 'pain severity and interference', 'Pain and Function', 'TG pain severity score and pain interference score', 'pain severity and interference scores', 'pain severity']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0026858', 'cui_str': 'Musculoskeletal pain'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C2735026', 'cui_str': 'Primary care provider'}]","[{'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0332461', 'cui_str': 'Plaque'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}]","[{'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0521102', 'cui_str': 'Interferes with'}, {'cui': 'C0221776', 'cui_str': 'Painful mouth'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0457451', 'cui_str': 'Severity score'}]",34.0,0.0419745,"Pain severity and interference scores decreased less in the CG (12.3% and 14.8%, respectively).","[{'ForeName': 'Jeffrey A', 'Initials': 'JA', 'LastName': 'Gudin', 'Affiliation': 'Englewood Hospital Medical Center, Englewood, NJ; Rutgers New Jersey Medical School, Department of Anesthesiology, Newark, NJ, USA.'}, {'ForeName': 'Derek T', 'Initials': 'DT', 'LastName': 'Dietze', 'Affiliation': 'Metrics for Learning LLC, Queen Creek, AZ, USA.'}, {'ForeName': 'Peter L', 'Initials': 'PL', 'LastName': 'Hurwitz', 'Affiliation': 'Clarity Science LLC, Narragansett, RI, USA.'}]",Journal of pain research,['10.2147/JPR.S258883'] 2750,32617017,Ultrasound-Guided Corticosteroid Injection in Carpal Tunnel Syndrome: Comparison Between Radial and Ulnar Approaches.,"Purpose To compare two common approaches for ultrasonography (US)-guided injection. Patients and Methods Sixty patients with mild-to-moderate CTS were included in this double-blind randomized controlled trial (RCT). They received a single shot of corticosteroid injection through either the US-guided in-plane approach: radial or ulnar side. Participants were evaluated using Boston Carpal Tunnel Questionnaire (BCTQ) and visual analogue scale (VAS) for pain, as well as electrodiagnosis (EDX) and US parameters before the intervention, and within 12 weeks of follow-up. Results In both groups, all outcomes, except for the electrodiagnostic measures, significantly improved within the follow-up. Pain-VAS and both subscales of BCTQ questionnaire, as our main subjective outcomes, revealed dramatic improvement, with the largest amount of changes in VAS (70%; comparing to baseline value), and about 37% for both of BQSS and BQFS scales, all indicating superiority of radial to ulnar in-plane approach. During the first follow-up, we did not detect any remarkable preference between the groups in either subjective or electrodiagnostic variables. However, there was a significant difference at next follow-up time-points in terms of VAS for pain and BQFS favoring radial approach (Table 3). Furthermore, US-measured parameters including nerve-circumference and CSA improved only in the radial in-plane group. Conclusion The current data proved that radial in-plane approach for CTS injection could be at least as effective as the more common ulnar in-plane method. Even the pain-relief effect was longer for the radial in-plane approach. Also, patients' functional status and objective variables all revealed better outcomes via the new approach.",2020,"During the first follow-up, we did not detect any remarkable preference between the groups in either subjective or electrodiagnostic variables.","['Carpal Tunnel Syndrome', 'Patients and Methods\n\n\nSixty patients with mild-to-moderate CTS']","['ultrasonography (US)-guided injection', 'corticosteroid injection through either the US-guided in-plane approach: radial or ulnar side', 'Ultrasound-Guided Corticosteroid Injection']","['electrodiagnostic measures', 'Pain-VAS and both subscales of BCTQ questionnaire', 'pain-relief effect', 'Boston Carpal Tunnel Questionnaire (BCTQ) and visual analogue scale (VAS) for pain, as well as electrodiagnosis (EDX', 'nerve-circumference and CSA']","[{'cui': 'C0007286', 'cui_str': 'Carpal tunnel syndrome'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}]","[{'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0444660', 'cui_str': 'Plane'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0442038', 'cui_str': 'Radial'}, {'cui': 'C0442044', 'cui_str': 'Ulnar'}]","[{'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0006037', 'cui_str': 'Boston'}, {'cui': 'C0007286', 'cui_str': 'Carpal tunnel syndrome'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0013816', 'cui_str': 'Electrodiagnosis'}, {'cui': 'C2699997', 'cui_str': 'Energy Dispersive X-Ray Fluorescence Spectroscopy'}, {'cui': 'C0000741', 'cui_str': 'Abducens nerve structure'}, {'cui': 'C0332520', 'cui_str': 'Circumference'}, {'cui': 'C0010592', 'cui_str': 'Cyclosporine'}]",60.0,0.0901068,"During the first follow-up, we did not detect any remarkable preference between the groups in either subjective or electrodiagnostic variables.","[{'ForeName': 'Arash', 'Initials': 'A', 'LastName': 'Babaei-Ghazani', 'Affiliation': 'Neuromusculoskeletal Research Center, Department of Physical Medicine and Rehabilitation, Iran University of Medical Sciences (IUMS), Tehran, Iran.'}, {'ForeName': 'Bijan', 'Initials': 'B', 'LastName': 'Forogh', 'Affiliation': 'Neuromusculoskeletal Research Center, Department of Physical Medicine and Rehabilitation, Iran University of Medical Sciences (IUMS), Tehran, Iran.'}, {'ForeName': 'Gholam Reza', 'Initials': 'GR', 'LastName': 'Raissi', 'Affiliation': 'Neuromusculoskeletal Research Center, Department of Physical Medicine and Rehabilitation, Iran University of Medical Sciences (IUMS), Tehran, Iran.'}, {'ForeName': 'Tannaz', 'Initials': 'T', 'LastName': 'Ahadi', 'Affiliation': 'Neuromusculoskeletal Research Center, Department of Physical Medicine and Rehabilitation, Iran University of Medical Sciences (IUMS), Tehran, Iran.'}, {'ForeName': 'Bina', 'Initials': 'B', 'LastName': 'Eftekharsadat', 'Affiliation': 'Physical Medicine and Rehabilitation Research Center, Department of Physical Medicine and Rehabilitation, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Naseh', 'Initials': 'N', 'LastName': 'Yousefi', 'Affiliation': 'Neuromusculoskeletal Research Center, Department of Physical Medicine and Rehabilitation, Iran University of Medical Sciences (IUMS), Tehran, Iran.'}, {'ForeName': 'Shahram', 'Initials': 'S', 'LastName': 'Rahimi-Dehgolan', 'Affiliation': 'Physical Medicine and Rehabilitation Department, IKHC Center, Tehran University of Medical Sciences (TUMS), Tehran, Iran.'}, {'ForeName': 'Katayoun', 'Initials': 'K', 'LastName': 'Moradi', 'Affiliation': 'Neuromusculoskeletal Research Center, Department of Physical Medicine and Rehabilitation, Iran University of Medical Sciences (IUMS), Tehran, Iran.'}]",Journal of pain research,['10.2147/JPR.S248600'] 2751,32617023,Clinical Efficacy of Transurethral Resection of the Prostate Combined with Oral Anticholinergics or Botulinum Toxin - A Injection to Treat Benign Prostatic Hyperplasia with Overactive Bladder: A Case-Control Study.,"Introduction Recent investigations showed that anticholinergic drugs could use for the management of storage symptoms after transurethral resection of the prostate (TURP). The use of intravesical botulinum toxin-A (BTX-A) for the management of overactive bladder is rapidly increasing. In this research, we assess the efficacy of BTX-A vs solifenacin in men suffering from bladder outlet obstruction-over active bladder (BOO-OAB) managed with TURP. Methods In this case-control study, 50 men with BOO-OAB randomized into two groups. The control group (A) underwent TURP and subsequently managed by solifenacin 5 mg daily, and the case group (B) underwent TURP and BTX-A injection in the bladder wall in the same session. Treatment success was the primary outcome and defined as post-injection improvement in the storage score of the International Prostate Symptom Score (IPSS) from baseline. Results The IPSS, post-void residual volume, frequency, incomplete emptying, nocturia and urgency subscores considerably ameliorated after 12 weeks and 36 weeks for both groups, but it was more significant in the case arm. The quality of life (QoL) scores significantly improved after the treatments in both groups. Intervention group showed significant reductions regarding urgency incontinence compared with the solifenacin group at 12th and 36th weeks. Conclusion BTX-A is an effective and well-tolerated treatment in patients with benign prostatic hyperplasia (BPH) who are candidates of TURP and simultaneously suffer from OAB symptoms.",2020,"Intervention group showed significant reductions regarding urgency incontinence compared with the solifenacin group at 12th and 36th weeks. ","['Benign Prostatic Hyperplasia with Overactive Bladder', 'patients with benign prostatic hyperplasia (BPH', 'storage symptoms after transurethral resection of the prostate (TURP', 'men suffering from bladder outlet obstruction-over active bladder (BOO-OAB) managed with TURP', '50 men with BOO-OAB']","['intravesical botulinum toxin-A (BTX-A', 'solifenacin', 'TURP and BTX-A injection', 'Transurethral Resection of the Prostate Combined with Oral Anticholinergics or Botulinum Toxin - A Injection', 'BTX-A vs solifenacin', 'TURP and subsequently managed by solifenacin']","['IPSS, post-void residual volume, frequency, incomplete emptying, nocturia and urgency subscores', 'storage score of the International Prostate Symptom Score (IPSS', 'urgency incontinence', 'quality of life (QoL) scores']","[{'cui': 'C0005001', 'cui_str': 'Hypertrophy, Benign Prostatic'}, {'cui': 'C0878773', 'cui_str': 'Overactive bladder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1698986', 'cui_str': 'Storage'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0040771', 'cui_str': 'Transurethral prostatectomy'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0005694', 'cui_str': 'Bladder neck obstruction'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0005682', 'cui_str': 'Urinary bladder structure'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}]","[{'cui': 'C0442124', 'cui_str': 'Intravesical approach'}, {'cui': 'C0006050', 'cui_str': 'Botulinum Toxin Type A'}, {'cui': 'C1099677', 'cui_str': 'Solifenacin'}, {'cui': 'C0040771', 'cui_str': 'Transurethral prostatectomy'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0242896', 'cui_str': 'Acetylcholine receptor antagonist'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}]","[{'cui': 'C1998280', 'cui_str': 'International prostate symptom score'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0042034', 'cui_str': 'Micturition'}, {'cui': 'C0035190', 'cui_str': 'Residual respiratory volume'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0205257', 'cui_str': 'Incomplete'}, {'cui': 'C0028734', 'cui_str': 'Nocturia'}, {'cui': 'C0439609', 'cui_str': 'Urgent'}, {'cui': 'C1698986', 'cui_str': 'Storage'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0015732', 'cui_str': 'Incontinence of feces'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",50.0,0.0473727,"Intervention group showed significant reductions regarding urgency incontinence compared with the solifenacin group at 12th and 36th weeks. ","[{'ForeName': 'Farzad', 'Initials': 'F', 'LastName': 'Allameh', 'Affiliation': 'Urology and Nephrology Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Abbas', 'Initials': 'A', 'LastName': 'Basiri', 'Affiliation': 'Urology and Nephrology Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohammadreza', 'Initials': 'M', 'LastName': 'Razzaghi', 'Affiliation': 'Laser Application in Medical Sciences Research Center, Shohada-e-Tajrish Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Amir Reza', 'Initials': 'AR', 'LastName': 'Abedi', 'Affiliation': 'Department of Urology, Shohada-e-Tajrish Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Morteza', 'Initials': 'M', 'LastName': 'Fallah-Karkan', 'Affiliation': 'Laser Application in Medical Sciences Research Center, Shohada-e-Tajrish Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Saleh', 'Initials': 'S', 'LastName': 'Ghiasy', 'Affiliation': 'Department of Urology, Shohada-e-Tajrish Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Seyyed Mohammad', 'Initials': 'SM', 'LastName': 'Hosseininia', 'Affiliation': 'Department of Urology, Shohada-e-Tajrish Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Saeed', 'Initials': 'S', 'LastName': 'Montazeri', 'Affiliation': 'Department of Urology, Shohada-e-Tajrish Hospital, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}]",Clinical pharmacology : advances and applications,['10.2147/CPAA.S256051'] 2752,32617061,"Comparison of the Oral Steroids, Macrolides and Combination Therapy in Nasal Polyposis Patients.","Objectives In this study, our aim was to compare oral steroid therapy with macrolide therapy and with oral steroid + macrolide (combine) therapy in patients with nasal polyposis (NP). Methods All patients were treated with nasal steroid therapy for eight weeks and divided randomly into three groups as follows: Oral steroid group, oral macrolide group and combine group. All patients underwent endoscopic staging, radiological grading, odour testing and completed the sino-nasal outcome test-22 (SNOT-22) questionnaire before and after treatment. Results Significant improvement was observed in all parameters after treatment in all three groups. All parameters were significantly better in the combined group than in the macrolide group. Comparison of the oral steroid group and macrolide group revealed significantly better radiological grading and odour test changes for the oral steroid group, but no statistically significant differences existed according to endoscopic staging and SNOT-22. The post-treatment SNOT-22 score was significantly better in the combined group than in the steroid group. A comparison of the combined and steroid groups showed better results for the combined group for all parameters, but the differences were not significant. Conclusion All treatment protocols were effective and the successful use of macrolide indicates its potential as an alternative in patients with contraindications to oral steroid treatment. The combined treatment may demonstrate significantly better results than steroid treatment alone if larger studies with more patients are performed.",2020,"Comparison of the oral steroid group and macrolide group revealed significantly better radiological grading and odour test changes for the oral steroid group, but no statistically significant differences existed according to endoscopic staging and SNOT-22.","['patients with nasal polyposis (NP', 'Nasal Polyposis Patients', 'patients with contraindications to oral steroid treatment']","['Oral Steroids, Macrolides and Combination Therapy', 'macrolide therapy and with oral steroid + macrolide (combine) therapy', 'oral macrolide', 'nasal steroid therapy', 'oral steroid', 'Oral steroid']",['radiological grading and odour test changes'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027430', 'cui_str': 'Polyp of nasal cavity'}, {'cui': 'C0522473', 'cui_str': 'Contraindication to'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0149783', 'cui_str': 'Administration of steroid'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0038317', 'cui_str': 'Steroid'}, {'cui': 'C0003240', 'cui_str': 'Macrolide antibiotic product'}, {'cui': 'C0009429', 'cui_str': 'Combination therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0149783', 'cui_str': 'Administration of steroid'}]","[{'cui': 'C0028884', 'cui_str': 'With odor'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}]",,0.0114184,"Comparison of the oral steroid group and macrolide group revealed significantly better radiological grading and odour test changes for the oral steroid group, but no statistically significant differences existed according to endoscopic staging and SNOT-22.","[{'ForeName': 'Fatih', 'Initials': 'F', 'LastName': 'Tetik', 'Affiliation': 'Department of Otorhinolaryngology Head and Neck Surgery, Gaziosmanpasa Taksim Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Arzu Yasemin', 'Initials': 'AY', 'LastName': 'Korkut', 'Affiliation': 'Department of Otorhinolaryngology Head and Neck Surgery, Sisli Hamidiye Etfal Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Kerem Sami', 'Initials': 'KS', 'LastName': 'Kaya', 'Affiliation': 'Department of Otorhinolaryngology Head and Neck Surgery, Sisli Hamidiye Etfal Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Irmak', 'Initials': 'I', 'LastName': 'Ucak', 'Affiliation': 'Department of Otorhinolaryngology Head and Neck Surgery, Istanbul Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey.'}, {'ForeName': 'Irfan', 'Initials': 'I', 'LastName': 'Celebi', 'Affiliation': 'Department of Radiology, Vehbi Koc Foundation American Hospital, Istanbul, Turkey.'}, {'ForeName': 'Berna Uslu', 'Initials': 'BU', 'LastName': 'Coskun', 'Affiliation': 'Department of Otorhinolaryngology Head and Neck Surgery, Sisli Hamidiye Etfal Training and Research Hospital, Istanbul, Turkey.'}]",Sisli Etfal Hastanesi tip bulteni,['10.14744/SEMB.2018.40316'] 2753,32617104,Comparative Effects of Isokinetic Training and Virtual Reality Training on Sports Performances in University Football Players with Chronic Low Back Pain-Randomized Controlled Study.,"Objective The objective of this study is to find and compare the effects of isokinetic training and virtual reality training on sports performances in university football players with chronic low back pain. Design This is a randomized, double-blinded controlled study. Methods The study was conducted on 45LBP participants at university hospital. First group ( n  = 15) received isokinetic training, second group ( n  = 15) received virtual reality training, and the control group ( n  = 15) received conventional training exercises for four weeks. Clinical (pain intensity and player wellness) and sports performance (40 m sprint, 4 × 5 m sprint, submaximal shuttle running, countermovement jump, and squat jump) scores were measured at baseline, after 4 weeks, 8 weeks, and 6 months. Results Four weeks following training VRT group shows more significant changes in pain intensity and player wellness scores than IKT and control groups ( p ≤ 0.001). Sports performance variables (such as 40 m sprint, 4 × 5 m sprint, submaximal shuttle running, countermovement jump, and squat jump) scores also show significant improvement in VRT group than the other two groups ( p ≤ 0.001). Conclusion Overall, our study suggests that strength training through virtual reality training protocol improves pain and sports performances than isokinetic training and other conventional trainings in university football players with chronic low back pain.",2020,Four weeks following training VRT group shows more significant changes in pain intensity and player wellness scores than IKT and control groups ( p ≤ 0.001).,"['University Football Players with Chronic Low Back Pain', '45LBP participants at university hospital', 'university football players with chronic low back pain']","['isokinetic training', 'isokinetic training and virtual reality training', 'isokinetic training, second group ( n \u2009=\u200915) received virtual reality training', 'Isokinetic Training and Virtual Reality Training', 'conventional training exercises']","['pain and sports performances', 'Clinical (pain intensity and player wellness) and sports performance (40\u2009m sprint, 4\u2009×\u20095\u2009m sprint, submaximal shuttle running, countermovement jump, and squat jump) scores', 'pain intensity and player wellness scores']","[{'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0016517', 'cui_str': 'American or Canadian football - sport'}, {'cui': 'C0457949', 'cui_str': 'Chronic low back pain'}, {'cui': 'C0020028', 'cui_str': 'University Hospitals'}]","[{'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0871966', 'cui_str': 'Sports Performance'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0221189', 'cui_str': 'Jumping'}, {'cui': 'C0241236', 'cui_str': 'Does squat'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.105939,Four weeks following training VRT group shows more significant changes in pain intensity and player wellness scores than IKT and control groups ( p ≤ 0.001).,"[{'ForeName': 'Gopal', 'Initials': 'G', 'LastName': 'Nambi', 'Affiliation': 'Department of Health and Rehabilitation Sciences, College of Applied Medical Sciences, Prince Sattam Bin Abdulaziz University, Al-Kharj, Saudi Arabia.'}, {'ForeName': 'Walid Kamal', 'Initials': 'WK', 'LastName': 'Abdelbasset', 'Affiliation': 'Department of Health and Rehabilitation Sciences, College of Applied Medical Sciences, Prince Sattam Bin Abdulaziz University, Al-Kharj, Saudi Arabia.'}, {'ForeName': 'Shereen H', 'Initials': 'SH', 'LastName': 'Elsayed', 'Affiliation': 'Department of Rehabilitation Sciences, Faculty of Health and Rehabilitation Sciences, Princess Nourah Bint Abdulrahman University, Riyadh, Saudi Arabia.'}, {'ForeName': 'Saud M', 'Initials': 'SM', 'LastName': 'Alrawaili', 'Affiliation': 'Department of Health and Rehabilitation Sciences, College of Applied Medical Sciences, Prince Sattam Bin Abdulaziz University, Al-Kharj, Saudi Arabia.'}, {'ForeName': 'Ahmed M', 'Initials': 'AM', 'LastName': 'Abodonya', 'Affiliation': 'Department of Anesthesia and Intensive Care, Faculty of Medicine, Al-Azhar University, Cairo, Egypt.'}, {'ForeName': 'Ayman K', 'Initials': 'AK', 'LastName': 'Saleh', 'Affiliation': 'College of Medicine, Prince Sattam Bin Abdulaziz University, Al-Kharj, Saudi Arabia.'}, {'ForeName': 'Tamer E', 'Initials': 'TE', 'LastName': 'Elnegamy', 'Affiliation': 'Department of Health and Rehabilitation Sciences, College of Applied Medical Sciences, Prince Sattam Bin Abdulaziz University, Al-Kharj, Saudi Arabia.'}]",Evidence-based complementary and alternative medicine : eCAM,['10.1155/2020/2981273'] 2754,32617105,The Effect of Foot Massage on Pain of the Intensive Care Patients: A Parallel Randomized Single-Blind Controlled Trial.,"Materials and Methods This randomized, parallel, single-blind controlled trial study was performed on 75 ICU patients. Patients were allocated into three groups (massage by a nurse, massage by the patient's family, and control group) by the minimization method. Swedish massage was provided for the patients in experimental groups (each foot for 5 minutes) once a day for six days. The pain was examined in all three groups before, immediately, and one week after the intervention. Results The mean scores of pain in the groups of foot massage by the patient's family and by a nurse showed a significant reduction at the end of the study (from 4.48 to 3.36 and 4.76 to 2.96, respectively). The control group had significantly more pain after the intervention than the family-based massage group and the nurse-based massage group ( P < 0.05). Although significant difference was found in the mean scores of pain between the massage provided by a nurse and that provided by the patient's family immediately after the intervention ( P < 0.05), it was not significant one week after the intervention ( P > 0.05). Conclusion Using foot massage, by both nurses and family members can reduce the pain of ICU patients. This intervention may improve the nursing care quality with the least cost and complications.",2020,The control group had significantly more pain after the intervention than the family-based massage group and the nurse-based massage group ( P < 0.05).,"['75 ICU patients', 'Pain of the Intensive Care Patients']",['Foot Massage'],"['mean scores of pain', 'pain']","[{'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]","[{'cui': 'C0016504', 'cui_str': 'Foot structure'}, {'cui': 'C0024875', 'cui_str': 'Massage'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",75.0,0.0192218,The control group had significantly more pain after the intervention than the family-based massage group and the nurse-based massage group ( P < 0.05).,"[{'ForeName': 'Masoumeh', 'Initials': 'M', 'LastName': 'Momeni', 'Affiliation': 'Student Research Committee, School of Nursing and Midwifery, Kerman University of Medical Sciences, Kerman, Iran.'}, {'ForeName': 'Mansoor', 'Initials': 'M', 'LastName': 'Arab', 'Affiliation': 'Faculty of Nursing and Midwifery, Bam University of Medical Sciences, Bam, Iran.'}, {'ForeName': 'Mahlagha', 'Initials': 'M', 'LastName': 'Dehghan', 'Affiliation': 'Nursing Research Center, Department of Critical Care Nursing, School of Nursing and Midwifery, Kerman University of Medical Sciences, Kerman, Iran.'}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Ahmadinejad', 'Affiliation': 'Department of Critical Care Medicine, Kerman University of Medical Sciences, Kerman, Iran.'}]",Evidence-based complementary and alternative medicine : eCAM,['10.1155/2020/3450853'] 2755,32617115,Mindful Exercise (Baduanjin) as an Adjuvant Treatment for Older Adults (60 Years Old and Over) of Knee Osteoarthritis: A Randomized Controlled Trial.,"Background The postural stability is a major factor that helps prevent developing knee osteoarthritis with aging. The aim of this study was to investigate the effects of Baduanjin qigong on postural control and physical function in older adults with knee osteoarthritis. Methods Fifty-six individuals over 60 years of age with knee osteoarthritis were randomly assigned to either an experimental group ( n  = 28) or a control group ( n  = 28). Participants in the experimental group received a 12-week Baduanjin training, while those in the control group did not receive any additional physical exercise during the study period. The postural control was quantified by perimeter and ellipse area of center of pressure movement trajectory. The assessments were conducted three times (baseline, week 8, and week 12). Results The perimeter and ellipse area with both open- and closed-eyes conditions and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) function were significantly improved at week eight in the experimental group ( p < 0.005). The ellipse area with open-eyes condition, WOMAC index, and stiffness and physical function domains were significantly decreased after the 12 weeks of Baduanjin training compared to the control group ( p < 0.005). Only the perimeter area with both open- and closed-eyes conditions was not statistically significant at week 12 in the intervention group ( p > 0.005). Conclusions Baduanjin is an effective and adjuvant therapy for older adults with knee osteoarthritis. Regular Baduanjin training can improve postural control and WOMAC function of old individuals with knee osteoarthritis. More advanced techniques and biopsychological measurements are required for further understanding of Baduanjin exercise in this population. The trial was registered in Chinese Clinical Trial Registry (ChiCTR-IOR-16010042).",2020,"Only the perimeter area with both open- and closed-eyes conditions was not statistically significant at week 12 in the intervention group ( p > 0.005). ","['Methods\n\n\nFifty-six individuals over 60 years of age with knee osteoarthritis', 'Older Adults (60 Years Old and Over) of Knee Osteoarthritis', 'older adults with knee osteoarthritis', 'old individuals with knee osteoarthritis']","['Regular Baduanjin training', 'Baduanjin training, while those in the control group did not receive any additional physical exercise', 'Baduanjin qigong', 'Mindful Exercise (Baduanjin']","['WOMAC index, and stiffness and physical function domains', 'postural control and WOMAC function', 'postural control and physical function', 'perimeter and ellipse area with both open- and closed-eyes conditions and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) function']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0282077', 'cui_str': 'Qigong'}]","[{'cui': 'C3472647', 'cui_str': 'Western Ontario and McMaster Universities osteoarthritis index'}, {'cui': 'C0427008', 'cui_str': 'Stiffness'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C4760618', 'cui_str': 'Posture Control'}, {'cui': 'C0182215', 'cui_str': 'Perimeter'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]",,0.0193535,"Only the perimeter area with both open- and closed-eyes conditions was not statistically significant at week 12 in the intervention group ( p > 0.005). ","[{'ForeName': 'JiaJia', 'Initials': 'J', 'LastName': 'Ye', 'Affiliation': 'Department of Rehabilitation Assessment, Rehabilitation Hospital Affiliated to Fujian University of Traditional Chinese Medicine, Fuzhou, Fujian 350000, China.'}, {'ForeName': 'Qikai', 'Initials': 'Q', 'LastName': 'Zheng', 'Affiliation': 'Department of Athletic Injury, Rehabilitation Hospital Affiliated to Fujian University of Traditional Chinese Medicine, Fuzhou, Fujian 350000, China.'}, {'ForeName': 'Liye', 'Initials': 'L', 'LastName': 'Zou', 'Affiliation': 'Exercise and Mental Health Laboratory, Shenzhen University, Shenzhen 518060, China.'}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Yu', 'Affiliation': 'Exercise and Mental Health Laboratory, Shenzhen University, Shenzhen 518060, China.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Veronese', 'Affiliation': 'National Research Council, Neuroscience Institute, Aging Branch, Padua, Italy.'}, {'ForeName': 'Igor', 'Initials': 'I', 'LastName': 'Grabovac', 'Affiliation': 'Department of Social and Preventive Medicine, Centre for Public Health, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Sinisa', 'Initials': 'S', 'LastName': 'Stefanac', 'Affiliation': 'Department of Social and Preventive Medicine, Centre for Public Health, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Huey-Ming', 'Initials': 'HM', 'LastName': 'Tzeng', 'Affiliation': 'The University of Texas Medical Branch at Galveston, School of Nursing, 301 University Boulevard, Galveston, Galveston, TX 77555, USA.'}, {'ForeName': 'Jane Jie', 'Initials': 'JJ', 'LastName': 'Yu', 'Affiliation': 'Department of Sports Science and Physical Education, The Chinese University of Hong Kong, Shatin, New Territories, Hong Kong 999077, China.'}]",Evidence-based complementary and alternative medicine : eCAM,['10.1155/2020/9869161'] 2756,32617173,The PTSD help app in a Danish PTSD population: research protocol of a randomized controlled feasibility trial.,"Background Due to an increase in PTSD patients seeking help in the Danish mental health sector and the addition of Complex PTSD to the ICD-11, there is a need to increase efficiency of existing treatments for PTSD. mHealth interventions have been shown to reduce PTSD symptoms. Therefore, the implementation of a mHealth intervention designed for psychiatric PTSD patients as a therapy add-on may improve treatment outcome. No study to date has explored the effects of mHealth interventions for PTSD in the Danish mental health sector, the feasibility and effect of this type of intervention needs testing. Methods The study is an investigator-initiated randomized controlled feasibility trial investigating the clinical mHealth tool PTSD help combined with care as usual (CAU) compared to CAU for adults with PTSD. Seventy patients will be recruited and receive either the mHealth intervention combined with CAU or CAU alone. The primary feasibility outcome is the proportion of eligible patients that participate in the study until the end assessment. Secondary outcome data consists of the fraction of compliant patients in the experimental group and exploratory data on PTSD help on PTSD symptom severity, level of psychological distress, sleep quality, dissociation symptoms, therapy readiness, quality of life, disability levels, and recovery. Discussion This study may help increase our knowledge of possible benefits of, as well as potential barriers to, the implementation of mHealth tools in the psychiatric sector. It may also provide a cost-efficient means to increase therapy outcomes and decrease the duration of suffering for PTSD patients in the psychiatric sector. Trial registration The trial is registered at ClinicalTrials.gov (ID: NCT03862703) https://clinicaltrials.gov/ct2/show/NCT03862703 on the 27 of February 2019 and has been approved by the Danish Data Protection Agency (journal number: VD-2018-200 ISuite number 6443). Referring to the committee law §2, the National Committee on Health Research Ethics (DNVK) [H-18024180] decided that the study could proceed without approval as the use of PTSD help did not constitute a health science intervention according to Danish health science legislation.",2020,The study is an investigator-initiated randomized controlled feasibility trial investigating the clinical mHealth tool PTSD help combined with care as usual (CAU) compared to CAU for adults with PTSD.,"['adults with PTSD', 'psychiatric PTSD patients', '27 of February 2019 and has been approved by the Danish Data Protection Agency (journal number: VD-2018-200 ISuite number 6443', 'Seventy patients will be recruited and receive either the']","['CAU', 'PTSD help combined with care as usual (CAU', 'mHealth intervention combined with CAU or CAU alone']","['PTSD help on PTSD symptom severity, level of psychological distress, sleep quality, dissociation symptoms, therapy readiness, quality of life, disability levels,\xa0and recovery', 'PTSD symptoms']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205540', 'cui_str': 'Approved'}, {'cui': 'C0010969', 'cui_str': 'Danish language'}, {'cui': 'C0086099', 'cui_str': 'Data Protection'}, {'cui': 'C0162443', 'cui_str': 'Journals as Topic'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C3816957', 'cui_str': '70'}]","[{'cui': 'C0444892', 'cui_str': 'CAU'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0815107', 'cui_str': 'Emotional Distress'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0086168', 'cui_str': 'Dissociation - mental defense mechanism'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C1318963', 'cui_str': 'Readiness'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0231170', 'cui_str': 'Disability'}]",70.0,0.0442214,The study is an investigator-initiated randomized controlled feasibility trial investigating the clinical mHealth tool PTSD help combined with care as usual (CAU) compared to CAU for adults with PTSD.,"[{'ForeName': 'Frederik Bernt', 'Initials': 'FB', 'LastName': 'Scharff', 'Affiliation': 'Unit for Psychotherapy Research, Psychotherapeutic Center Stolpegaard, Mental Health Services, Stolpegaardsvej 20, 2820 Gentofte, Capital Region of Denmark Denmark.'}, {'ForeName': 'Marianne Engelbrecht', 'Initials': 'ME', 'LastName': 'Lau', 'Affiliation': 'Unit for Psychotherapy Research, Psychotherapeutic Center Stolpegaard, Mental Health Services, Stolpegaardsvej 20, 2820 Gentofte, Capital Region of Denmark Denmark.'}, {'ForeName': 'Lisa Helena Grønberg', 'Initials': 'LHG', 'LastName': 'Riisager', 'Affiliation': 'Unit for Psychotherapy Research, Psychotherapeutic Center Stolpegaard, Mental Health Services, Stolpegaardsvej 20, 2820 Gentofte, Capital Region of Denmark Denmark.'}, {'ForeName': 'Stine Bjerrum', 'Initials': 'SB', 'LastName': 'Møller', 'Affiliation': 'Unit for Psychotherapy Research, Psychotherapeutic Center Stolpegaard, Mental Health Services, Stolpegaardsvej 20, 2820 Gentofte, Capital Region of Denmark Denmark.'}, {'ForeName': 'Mehrak Lykkeberg', 'Initials': 'ML', 'LastName': 'Salimi', 'Affiliation': 'Hejmdal Private Psychiatric Hospital, Martinsvej 7-9, 1926 Frederiksberg C, Denmark.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Gondan', 'Affiliation': 'Unit for Psychotherapy Research, Psychotherapeutic Center Stolpegaard, Mental Health Services, Stolpegaardsvej 20, 2820 Gentofte, Capital Region of Denmark Denmark.'}, {'ForeName': 'Sofie', 'Initials': 'S', 'LastName': 'Folke', 'Affiliation': 'Department for Military Psychology, Danish Veteran Center, Danish Defence, Svanemøllens Kaserne, Ryvangs Allé 1, 2100 Copenhagen, Denmark.'}]",Pilot and feasibility studies,['10.1186/s40814-020-00633-x'] 2757,32617293,Neuronavigation-guided focused ultrasound (NaviFUS) for transcranial blood-brain barrier opening in recurrent glioblastoma patients: clinical trial protocol.,"Background Blood-brain barrier (BBB) limits over 95% of drugs' penetration into brain, which has been a major obstacle in treating patients with glioblastoma. Transient BBB opening in glioblastoma (GBM) is feasible by combining focused ultrasound (FUS) with systemic infusion of microbubbles (MB). NaviFUS, a novel device that integrates neuronavigation and FUS-MB system, is able to intraoperatively direct the ultrasound energy precisely and repeatedly at targeted CNS areas. This clinical trial evaluates the safety and feasibility of NaviFUS in recurrent glioblastoma patients. Methods The study is a first-in-human, prospective, open-label, single-center, single-arm, dose escalation phase 1 clinical trial. A total of 6 patients will be enrolled. Patients will be enrolled into three groups, each group receiving an escalating dose of FUS energy (acoustic power is 4, 8, and 12 W) with concomitant systemic microbubbles (0.1 mL/kg) applied 1 week before surgical resection. Results Dynamic contrast-enhanced MRI will be obtained immediately and 24 hours after FUS procedures, while heavily T2-weighted sequence will be obtained to evaluate for any micro-hemorrhages. We anticipate that there will be minimal side effects associated with NaviFUS-mediated transient BBB opening. Conclusions Obtained results will support a planned phase 2 trial to evaluate whether NaviFUS can effectively enhance the delivery of chemotherapeutic agents and improve tumor control.",2020,"NaviFUS, a novel device that integrates neuronavigation and FUS-MB system, is able to intraoperatively direct the ultrasound energy precisely and repeatedly at targeted CNS areas.","['recurrent glioblastoma patients', '6 patients will be enrolled', 'patients with glioblastoma']","['FUS energy (acoustic power is 4, 8, and 12 W) with concomitant systemic microbubbles', 'NaviFUS', 'Transient BBB opening in glioblastoma (GBM', 'Neuronavigation-guided focused ultrasound (NaviFUS']",['\n\n\nBlood-brain barrier (BBB) limits'],"[{'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0017636', 'cui_str': 'Glioblastoma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0000936', 'cui_str': 'Ocular accommodation'}, {'cui': 'C0041620', 'cui_str': 'Therapeutic ultrasound'}, {'cui': 'C0001166', 'cui_str': 'Acoustics'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C1258018', 'cui_str': 'Microbubbles'}, {'cui': 'C0040704', 'cui_str': 'Transients'}, {'cui': 'C0005854', 'cui_str': 'Brain-Blood Barrier'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0017636', 'cui_str': 'Glioblastoma'}, {'cui': 'C1136207', 'cui_str': 'Frameless Stereotaxy'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}]","[{'cui': 'C0005854', 'cui_str': 'Brain-Blood Barrier'}, {'cui': 'C0439801', 'cui_str': 'Limited'}]",6.0,0.0578683,"NaviFUS, a novel device that integrates neuronavigation and FUS-MB system, is able to intraoperatively direct the ultrasound energy precisely and repeatedly at targeted CNS areas.","[{'ForeName': 'Ko-Ting', 'Initials': 'KT', 'LastName': 'Chen', 'Affiliation': 'Department of Neurosurgery, Chang Gung Memorial Hospital at Linkou, Taipei.'}, {'ForeName': 'Ya-Jui', 'Initials': 'YJ', 'LastName': 'Lin', 'Affiliation': 'Department of Neurosurgery, Chang Gung Memorial Hospital at Linkou, Taipei.'}, {'ForeName': 'Wen-Yen', 'Initials': 'WY', 'LastName': 'Chai', 'Affiliation': 'Department of Diagnostic Radiology and Intervention, Chang Gung Memorial Hospital at LinKou, Linkou, Taipei.'}, {'ForeName': 'Chia-Jung', 'Initials': 'CJ', 'LastName': 'Lin', 'Affiliation': 'Department of Electrical Engineering, Chang Gung University, Linkou, Taipei.'}, {'ForeName': 'Pin-Yuan', 'Initials': 'PY', 'LastName': 'Chen', 'Affiliation': 'Department of Neurosurgery, Chang Gung Memorial Hospital at Keelung, New Taipei.'}, {'ForeName': 'Chiung-Yin', 'Initials': 'CY', 'LastName': 'Huang', 'Affiliation': 'Department of Neurosurgery, New Taipei Municipal TuCheng Hospital, Chang Gung Memorial Hospital and Chang Gung University, Linkou, Taipei.'}, {'ForeName': 'John S', 'Initials': 'JS', 'LastName': 'Kuo', 'Affiliation': 'Department of Neurosurgery and Mulva Clinic for the Neurosciences, Dell Medical School, The University of Texas at Austin, Austin, TX, USA.'}, {'ForeName': 'Hao-Li', 'Initials': 'HL', 'LastName': 'Liu', 'Affiliation': 'Department of Neurosurgery, Chang Gung Memorial Hospital at Linkou, Taipei.'}, {'ForeName': 'Kuo-Chen', 'Initials': 'KC', 'LastName': 'Wei', 'Affiliation': 'Department of Neurosurgery, New Taipei Municipal TuCheng Hospital, Chang Gung Memorial Hospital and Chang Gung University, Linkou, Taipei.'}]",Annals of translational medicine,['10.21037/atm-20-344'] 2758,32614201,Proactive tobacco treatment for veterans with posttraumatic stress disorder.,"OBJECTIVE Individuals with posttraumatic stress disorder (PTSD) smoke at higher rates compared to the general population and experience significant barriers to initiating cessation treatment. Proactive outreach addresses these barriers by directly engaging with smokers and facilitating access to treatment. The objective of the present study was to evaluate a proactive outreach intervention for increasing rates of treatment utilization and abstinence among veteran smokers with and without PTSD. METHOD This is a secondary analysis of a randomized controlled trial conducted from 2013 to 2017 that demonstrated the effectiveness of proactive outreach among veterans using Veterans Affairs mental health care services. Electronic medical record data were used to identify participants with ( n = 355) and without ( n = 1,583) a diagnosis of PTSD. Logistic regressions modeled cessation treatment utilization (counseling, nicotine replacement therapy [NRT], and combination treatment) and abstinence (7-day point prevalence and 6-month prolonged at 6- and 12-month follow-ups) among participants randomized to proactive outreach versus usual care in the PTSD and non-PTSD subgroups, respectively. RESULTS Compared to usual care, proactive outreach increased combined counseling and NRT utilization among participants with PTSD (odds ratio [ OR ] = 26.25, 95% confidence interval [3.43, 201.17]) and without PTSD ( OR = 10.20, [5.21, 19.98]). Proactive outreach also increased 7-day point prevalence abstinence at 12 months among participants with PTSD ( OR = 2.62, [1.16, 5.91]) and without PTSD ( OR = 1.61, [1.11, 2.34]). CONCLUSIONS Proactive outreach increased treatment utilization and abstinence among smokers with and without PTSD. Smokers with PTSD may need additional facilitation to initiate cessation treatment but are receptive when it is offered proactively. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,"Compared to usual care, proactive outreach increased combined counseling and NRT utilization among participants with PTSD (odds ratio [ OR ] = 26.25, 95% confidence interval [3.43, 201.17]) and without PTSD ( OR = 10.20, [5.21, 19.98]).","['veteran smokers with and without PTSD', 'veterans using Veterans Affairs mental health care services', 'participants with ( n = 355) and without ( n = 1,583) a diagnosis of PTSD', 'Individuals with posttraumatic stress disorder (PTSD', 'Smokers with PTSD', 'smokers with and without PTSD', 'veterans with posttraumatic stress disorder']","['Proactive tobacco treatment', 'proactive outreach versus usual care in the PTSD and non-PTSD subgroups, respectively', 'proactive outreach', 'Proactive outreach', 'proactive outreach intervention', 'nicotine replacement therapy [NRT']","['7-day point prevalence abstinence', 'treatment utilization and abstinence']","[{'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0184643', 'cui_str': 'Mental health care'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0040329', 'cui_str': 'Tobacco'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C1278444', 'cui_str': 'Nicotine replacement therapy'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0042153', 'cui_str': 'utilization'}]",,0.0150739,"Compared to usual care, proactive outreach increased combined counseling and NRT utilization among participants with PTSD (odds ratio [ OR ] = 26.25, 95% confidence interval [3.43, 201.17]) and without PTSD ( OR = 10.20, [5.21, 19.98]).","[{'ForeName': 'Patrick J', 'Initials': 'PJ', 'LastName': 'Hammett', 'Affiliation': 'VA HSR&D Center for Care Delivery and Outcomes Research.'}, {'ForeName': 'Sandra J', 'Initials': 'SJ', 'LastName': 'Japuntich', 'Affiliation': 'Hennepin Healthcare Research Institute.'}, {'ForeName': 'Scott E', 'Initials': 'SE', 'LastName': 'Sherman', 'Affiliation': 'Department of Population Health.'}, {'ForeName': 'Erin S', 'Initials': 'ES', 'LastName': 'Rogers', 'Affiliation': 'Department of Population Health.'}, {'ForeName': 'Elisheva R', 'Initials': 'ER', 'LastName': 'Danan', 'Affiliation': 'VA HSR&D Center for Care Delivery and Outcomes Research.'}, {'ForeName': 'Siamak', 'Initials': 'S', 'LastName': 'Noorbaloochi', 'Affiliation': 'VA HSR&D Center for Care Delivery and Outcomes Research.'}, {'ForeName': 'Omar', 'Initials': 'O', 'LastName': 'El-Shahawy', 'Affiliation': 'Department of Population Health.'}, {'ForeName': 'Diana J', 'Initials': 'DJ', 'LastName': 'Burgess', 'Affiliation': 'VA HSR&D Center for Care Delivery and Outcomes Research.'}, {'ForeName': 'Steven S', 'Initials': 'SS', 'LastName': 'Fu', 'Affiliation': 'VA HSR&D Center for Care Delivery and Outcomes Research.'}]","Psychological trauma : theory, research, practice and policy",['10.1037/tra0000613'] 2759,32614227,Feasibility and acceptability of a novel tool for the study of interpersonal processes in psychotherapy.,"Psychotherapy process research methods often require extensive time and resources. Technology innovations, such as wearable sensors, have the potential to increase the efficiency of process data collection and processing. One such tool is the Sociometric Badge (SB), which is a portable, palm-sized device that can simultaneously record raw audio and data on social signals (e.g., speech patterns, body movement) in real-time and in varied contexts. In addition to describing the nature and implications of wearable sensing devices for psychotherapy research, this article reports results from a pilot study that examined the feasibility and acceptance of these assessment devices in comparison with traditional audio recording equipment. Undergraduate students (N = 306; Mage = 19.16 years, SD = 1.44; 50.3% female) were randomly placed into 153 dyads to mimic a psychotherapy dyad. Each dyad was randomly assigned to either a SB condition (n = 75 dyads) or a standard recording device condition (n = 78 dyads), and engaged in a conversation task. Participants completed self-report items assessing perceived relationship quality and experience with the respective recording device. Between-condition tests showed that perceived relationship quality did not differ between conditions. Participants in the audio recorder (vs. SB) condition reported more awareness of the device in the room. These findings reveal comparable acceptability and feasibility of SBs to traditional audio recorders in a simulated dyad, suggesting that wearable sensing devices may be suitable for research and practice in routine psychotherapy contexts. (PsycInfo Database Record (c) 2020 APA, all rights reserved).",2020,Between-condition tests showed that perceived relationship quality did not differ between conditions.,"['Undergraduate students (N = 306; Mage = 19.16 years, SD = 1.44; 50.3% female']","['standard recording device condition', 'SB condition']","['relationship quality', 'Feasibility and acceptability']","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}]","[{'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}]",,0.0364484,Between-condition tests showed that perceived relationship quality did not differ between conditions.,"[{'ForeName': 'Carly M', 'Initials': 'CM', 'LastName': 'Schwartzman', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Brittany R', 'Initials': 'BR', 'LastName': 'King', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Anna-Kaisa', 'Initials': 'AK', 'LastName': 'Newheiser', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Jennifer M', 'Initials': 'JM', 'LastName': 'Oswald', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Matteo', 'Initials': 'M', 'LastName': 'Bugatti', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'Elijah', 'Initials': 'E', 'LastName': 'Cedeno', 'Affiliation': 'Department of Psychology.'}, {'ForeName': 'James F', 'Initials': 'JF', 'LastName': 'Boswell', 'Affiliation': 'Department of Psychology.'}]",Journal of counseling psychology,['10.1037/cou0000385'] 2760,32614262,A Preliminary Study of the Effects of Treatment with Lithium Versus Quetiapine on Attention of Adolescents with Bipolar Disorder.,"Objectives: Despite attentional deficits being a prominent feature of bipolar disorder, there are limited data on the effects of common treatments for bipolar disorder on attention. Thus, we sought to compare the effects of lithium versus quetiapine on attention in adolescents with bipolar disorder. Methods: Adolescents ages 10-17 with bipolar disorder, type I, who were experiencing a manic or mixed episode, were recruited from outpatient settings and the inpatient psychiatric units at Cincinnati Children's Hospital Medical Center during their first manic episode. Healthy comparison subjects were recruited from outreach programs in the community. Patients were randomized to lithium or quetiapine, administered in a double-dummy, double-blinded manner for 6 weeks. Attentional deficits were assessed in all groups using the Identical Pairs Continuous Performance Task at baseline and at week 6. Results: Patients with bipolar disorder ( n  = 79) had impaired attention relative to the healthy group ( n  = 57) at both baseline and after 6 weeks of treatment. The lithium-treated group ( n  = 30) had poorer attentional performance than the healthy group at week 6. There was a difference in change in performance between lithium- and quetiapine-treated ( n  = 49) groups. Conclusion: Youth with bipolar disorder may have impaired attention relative to their healthy peers. Conclusions are limited by the high dropout rate in the lithium-treated group.",2020,There was a difference in change in performance between lithium- and quetiapine-treated ( n  = 49) groups. ,"[""Adolescents ages 10-17 with bipolar disorder, type I, who were experiencing a manic or mixed episode, were recruited from outpatient settings and the inpatient psychiatric units at Cincinnati Children's Hospital Medical Center during their first manic episode"", 'Healthy comparison subjects were recruited from outreach programs in the community', 'Adolescents with Bipolar Disorder', 'Youth with bipolar disorder', 'adolescents with bipolar disorder', 'Patients with bipolar disorder ( n \u2009=\u200979']","['lithium versus quetiapine', 'lithium or quetiapine', 'quetiapine', 'Lithium Versus Quetiapine']","['poorer attentional performance', 'Attentional deficits']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005586', 'cui_str': 'Bipolar disorder'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0338831', 'cui_str': 'Mania'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0748064', 'cui_str': 'Psychiatric in-patient'}, {'cui': 'C0439148', 'cui_str': 'Unit'}, {'cui': 'C0020017', 'cui_str': ""Children's hospital""}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0349208', 'cui_str': 'Manic episode, unspecified'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0023870', 'cui_str': 'Lithium'}, {'cui': 'C0123091', 'cui_str': 'quetiapine'}]","[{'cui': 'C0032854', 'cui_str': 'Financially poor'}]",,0.137722,There was a difference in change in performance between lithium- and quetiapine-treated ( n  = 49) groups. ,"[{'ForeName': 'Joshua V', 'Initials': 'JV', 'LastName': 'Streicher', 'Affiliation': 'Division of Bipolar Disorders Research, Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, Cincinnati, Ohio, USA.'}, {'ForeName': 'Hongbo', 'Initials': 'H', 'LastName': 'Wen', 'Affiliation': 'Division of Bipolar Disorders Research, Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, Cincinnati, Ohio, USA.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Blom', 'Affiliation': 'Division of Bipolar Disorders Research, Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, Cincinnati, Ohio, USA.'}, {'ForeName': 'Maxwell J', 'Initials': 'MJ', 'LastName': 'Tallman', 'Affiliation': 'Division of Bipolar Disorders Research, Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, Cincinnati, Ohio, USA.'}, {'ForeName': 'Jeffrey R', 'Initials': 'JR', 'LastName': 'Strawn', 'Affiliation': 'Division of Bipolar Disorders Research, Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, Cincinnati, Ohio, USA.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Klein', 'Affiliation': 'Division of Bipolar Disorders Research, Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, Cincinnati, Ohio, USA.'}, {'ForeName': 'L Rodrigo', 'Initials': 'LR', 'LastName': 'Patino', 'Affiliation': 'Division of Bipolar Disorders Research, Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, Cincinnati, Ohio, USA.'}, {'ForeName': 'Melissa P', 'Initials': 'MP', 'LastName': 'DelBello', 'Affiliation': 'Division of Bipolar Disorders Research, Department of Psychiatry and Behavioral Neuroscience, University of Cincinnati College of Medicine, Cincinnati, Ohio, USA.'}]",Journal of child and adolescent psychopharmacology,['10.1089/cap.2019.0169'] 2761,32614422,Association of Atrial Fibrillation Episode Duration With Arrhythmia Recurrence Following Ablation: A Secondary Analysis of a Randomized Clinical Trial.,"Importance Contemporary guidelines recommend that atrial fibrillation (AF) be classified based on episode duration, with these categories forming the basis of therapeutic recommendations. While pragmatic, these classifications are not based on pathophysiologic processes and may not reflect clinical outcomes. Objective To evaluate the association of baseline AF episode duration with post-AF ablation arrhythmia outcomes. Design, Setting, and Participants The current study is a secondary analysis of a prospective, parallel-group, multicenter, single-masked randomized clinical trial (the Cryoballoon vs Irrigated Radiofrequency Catheter Ablation: Double Short vs Standard Exposure Duration [CIRCA-DOSE] study), which took place at 8 Canadian centers. Between September 2014 and July 2017, 346 patients older than 18 years with symptomatic AF referred for first catheter ablation were enrolled. All patients received an implantable cardiac monitor at least 30 days before ablation. Data analysis was performed in September 2019. Exposure Before ablation, patients were classified based on their longest AF episode. Ablation consisted of circumferential pulmonary vein isolation using standard techniques. Main Outcomes and Measures Time to first recurrence of symptomatic or asymptomatic atrial tachyarrhythmia (AF, atrial flutter, or atrial tachycardia) following ablation and AF burden (percentage of time in AF) on preablation and postablation continuous rhythm monitoring. Results The study included 346 patients (mean [SD] age, 59 [10] years; 231 [67.7%] men). Overall, 263 patients (76.0%) had AF episode duration of less than 24 hours; 25 (7.2%), 24 to 48 hours; 40 (11.7%), 2 to 7 days; and 18 (5.2%), more than 7 days. Documented recurrence of any atrial tachyarrhythmia following ablation was significantly lower in patients with baseline AF episode duration of less than 24 continuous hours compared with those with longer AF episodes (24 hours vs 24-48 hours: hazard ratio [HR], 0.41; 95% CI, 0.21-0.80; P = .009; 24 hours vs 2-7 days: HR, 0.25; 95% CI, 0.14-0.45; P < .001; 24 hours vs >7 days: HR, 0.23; 95% CI, 0.09-0.55; P < .001). Patients with preablation AF episodes limited to less than 24 continuous hours had a significantly lower median (interquartile range) postablation AF burden (0% [0%-0.1%]) compared with those with AF preablation episodes lasting 2-7 days (0.1% [0%-1.0%]; P = .003) and those with AF preablation episodes lasting more than 7 days (1.0% [0%-5.4%]; P = .008). There was no significant difference in arrhythmia recurrence or AF burden between the 3 groups with a baseline AF episode duration of longer than 24 hours. Conclusions and Relevance In this study, patients with AF episodes limited to less than 24 continuous hours had a significantly lower incidence of arrhythmia recurrence following AF ablation. This suggests that current guidelines for classification of AF may not reflect clinical outcomes. Trial Registration ClinicalTrials.gov Identifier: NCT01913522.",2020,"There was no significant difference in arrhythmia recurrence or AF burden between the 3 groups with a baseline AF episode duration of longer than 24 hours. ","['Between September 2014 and July 2017, 346 patients older than 18 years with symptomatic AF referred for first catheter ablation were enrolled', '346 patients (mean [SD] age, 59 [10] years; 231 [67.7%] men']","['Cryoballoon vs Irrigated Radiofrequency Catheter Ablation: Double Short vs Standard Exposure Duration [CIRCA-DOSE', 'circumferential pulmonary vein isolation using standard techniques', 'Ablation']","['recurrence of any atrial tachyarrhythmia following ablation', 'Measures\n\n\nTime to first recurrence of symptomatic or asymptomatic atrial tachyarrhythmia (AF, atrial flutter, or atrial tachycardia) following ablation and AF burden (percentage of time in AF) on preablation and postablation continuous rhythm monitoring', 'AF episode duration', 'median (interquartile range) postablation AF burden', 'arrhythmia recurrence or AF burden', 'Atrial Fibrillation Episode Duration With Arrhythmia Recurrence', 'arrhythmia recurrence']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C1691010', 'cui_str': 'Referral placed'}, {'cui': 'C0162563', 'cui_str': 'Cardiac ablation'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0162561', 'cui_str': 'Radiofrequency Catheter Ablation'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0205113', 'cui_str': 'Circumferential'}, {'cui': 'C3544330', 'cui_str': 'Pulmonary vein isolation'}, {'cui': 'C0025664', 'cui_str': 'methods'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}]","[{'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0018792', 'cui_str': 'Atrial structure'}, {'cui': 'C0080203', 'cui_str': 'Tachyarrhythmia'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0547070', 'cui_str': 'Ablation - action'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0004238', 'cui_str': 'Atrial fibrillation'}, {'cui': 'C0004239', 'cui_str': 'Atrial flutter'}, {'cui': 'C0030587', 'cui_str': 'Atrial paroxysmal tachycardia'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0003811', 'cui_str': 'Cardiac arrhythmia'}]",346.0,0.182789,"There was no significant difference in arrhythmia recurrence or AF burden between the 3 groups with a baseline AF episode duration of longer than 24 hours. ","[{'ForeName': 'Jason G', 'Initials': 'JG', 'LastName': 'Andrade', 'Affiliation': 'Montreal Heart Institute, Department of Medicine, Université de Montréal, Montréal, Quebec, Canada.'}, {'ForeName': 'Marc W', 'Initials': 'MW', 'LastName': 'Deyell', 'Affiliation': 'Department of Medicine, University of British Columbia, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Atul', 'Initials': 'A', 'LastName': 'Verma', 'Affiliation': 'Southlake Regional Health Center, Newmarket, Ontario, Canada.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Macle', 'Affiliation': 'Montreal Heart Institute, Department of Medicine, Université de Montréal, Montréal, Quebec, Canada.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Champagne', 'Affiliation': 'Université Laval, Quebec City, Quebec, Canada.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Leong-Sit', 'Affiliation': 'University of Western Ontario, London, Ontario, Canada.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Novak', 'Affiliation': 'Royal Jubilee Hospital, Victoria, British Columbia, Canada.'}, {'ForeName': 'Mariano', 'Initials': 'M', 'LastName': 'Badra-Verdu', 'Affiliation': 'Centre Hospitalier Universitaire de Sherbrooke, Sherbrooke, Quebec, Canada.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Sapp', 'Affiliation': 'Queen Elizabeth II Health Sciences Centre, Dalhousie University, Halifax, Nova Scotia, Canada.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Khairy', 'Affiliation': 'Montreal Heart Institute, Department of Medicine, Université de Montréal, Montréal, Quebec, Canada.'}, {'ForeName': 'Stanley', 'Initials': 'S', 'LastName': 'Nattel', 'Affiliation': 'Montreal Heart Institute, Department of Medicine, Université de Montréal, Montréal, Quebec, Canada.'}]",JAMA network open,['10.1001/jamanetworkopen.2020.8748'] 2762,32614482,A brief self-compassion intervention for adolescents with type 1 diabetes and disordered eating: a feasibility study.,"AIM To examine the feasibility and acceptability of a brief self-compassion intervention for adolescents with type 1 diabetes and disordered eating behaviour. METHODS Twenty-seven adolescents with type 1 diabetes were recruited and randomized to receive the brief (two 2.5-h sessions) self-compassion intervention, either in the intervention group (n=11) or in a waitlist control group (n=8). The intervention was adapted from the standardized eight-session 'Making Friends with Yourself' programme, and sessions were delivered 1 week apart. Acceptability was assessed through qualitative questionnaires and feasibility was assessed based on session attendance and recruitment metrics. Possible changes to disordered eating behaviour, self-care behaviours, diabetes-related distress, self-compassion, stress and glycaemic control were also assessed. RESULTS Nineteen participants completed the study, and they reported an increased sense of common humanity (acknowledging that we are not alone), mindfulness, and coping resources. In terms of feasibility, recruitment took longer than expected (8 months) and not all participants were able to attend both sessions (nine could only attend one of the two sessions). CONCLUSIONS While self-compassion is a strong conceptual fit for the issues of type 1 diabetes and disordered eating behaviour in adolescence, and the intervention content appears acceptable, feasibility issues were such that brief self-compassion programmes will probably need to be adapted into digital interventions for future research.",2020,"Possible changes to disordered eating behaviour, self-care behaviours, diabetes-related distress, self-compassion, stress and glycaemic control were also assessed. ","['Twenty-seven adolescents with type 1 diabetes', 'adolescents with type 1 diabetes and disordered eating', 'adolescents with type 1 diabetes and disordered eating behaviour', 'Nineteen participants']","['brief self-compassion intervention', 'self-compassion intervention']","['feasibility and acceptability', 'disordered eating behaviour, self-care behaviours, diabetes-related distress, self-compassion, stress and glycaemic control', 'Acceptability']","[{'cui': 'C4319602', 'cui_str': '27'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0855228', 'cui_str': 'Eating disorder symptom'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0450337', 'cui_str': '19'}]","[{'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0855228', 'cui_str': 'Eating disorder symptom'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0474417', 'cui_str': 'Self-care behavior'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",27.0,0.0257097,"Possible changes to disordered eating behaviour, self-care behaviours, diabetes-related distress, self-compassion, stress and glycaemic control were also assessed. ","[{'ForeName': 'A L', 'Initials': 'AL', 'LastName': 'Boggiss', 'Affiliation': 'Department of Psychological Medicine, Faculty of Medical and Health Sciences, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'N S', 'Initials': 'NS', 'LastName': 'Consedine', 'Affiliation': 'Department of Psychological Medicine, Faculty of Medical and Health Sciences, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'K R', 'Initials': 'KR', 'LastName': 'Schache', 'Affiliation': 'Department of Psychological Medicine, Faculty of Medical and Health Sciences, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Jefferies', 'Affiliation': ""Starship Children's Health, Auckland City Hospital, Auckland, New Zealand.""}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Bluth', 'Affiliation': 'Department of Psychiatry, University of North Carolina, Chapel Hill, NC, USA.'}, {'ForeName': 'P L', 'Initials': 'PL', 'LastName': 'Hofman', 'Affiliation': 'Liggins Institute, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'A S', 'Initials': 'AS', 'LastName': 'Serlachius', 'Affiliation': 'Department of Psychological Medicine, Faculty of Medical and Health Sciences, University of Auckland, Auckland, New Zealand.'}]",Diabetic medicine : a journal of the British Diabetic Association,['10.1111/dme.14352'] 2763,32609465,Neck-Related Headache in Patients With Cervical Disc Disease After Surgery and Physiotherapy: A 1-Year Follow-up of a Prospective Randomized Study.,"STUDY DESIGN A prospective randomized multicenter trial. OBJECTIVE To investigate the effects of surgery with either structured postoperative physiotherapy or standard postoperative approach on neck-related headache in patients with cervical radiculopathy. Secondary, to investigate associations between change in neck-related headache and change in neck muscle endurance, neck mobility, or neck pain. SUMMARY OF BACKGROUND DATA The effect of physiotherapy on individuals with neck-related headache after surgery for cervical radiculopathy due to magnetic resonance imaging-verified disc disease is unknown. METHODS One hundred six patients with neck-related headache and participating in a randomized controlled trial evaluating the additional effects of physiotherapy after surgery for cervical radiculopathy were included. Patients were randomized preoperatively to structured postoperative physiotherapy (n = 51) or the standard postoperative approach (n = 55). Outcome measures were headache intensity and neck pain intensity, neck muscle endurance, and neck mobility. Measures were obtained preoperatively and at 6 weeks, 3 months, 6 months, and 1 year postoperatively. RESULTS Headache intensity significantly changed from baseline to 1 year postoperatively (P < 0.001) in both groups. Post-hoc tests showed a significant difference between baseline and 6 weeks (P ≤ 0.05). No significant differences were found between groups (P > 0.05) or between-group differences in changes over time (P > 0.05). The change in current headache intensity over time was associated with a change in current neck pain intensity over time (P = 0.003, β = 0.40). CONCLUSION There was a significant improvement in headache intensity 1 year postoperatively in patients with cervical radiculopathy and neck-related headache, but there were no differences between groups over time. Change in current headache intensity was only associated with a change in current neck pain intensity. LEVEL OF EVIDENCE 2.",2020,"There was a significant improvement in headache intensity 1 year postoperatively in patients with cervical radiculopathy and neck-related headache, but there were no differences between groups over time.","['patients with cervical radiculopathy', 'individuals with neck-related headache after surgery for cervical radiculopathy due to magnetic resonance imaging-verified disc disease', 'after surgery for cervical radiculopathy were included', 'One hundred six patients with neck-related headache and participating', 'Patients With Cervical Disc Disease']","['surgery with either structured postoperative physiotherapy or standard postoperative approach', 'physiotherapy', 'Physiotherapy', 'structured postoperative physiotherapy (n\u200a=\u200a51) or the standard postoperative approach']","['neck-related headache and change in neck muscle endurance, neck mobility, or neck pain', 'current neck pain intensity', 'headache intensity and neck pain intensity, neck muscle endurance, and neck mobility', 'headache intensity', 'current headache intensity', 'Headache intensity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0742186', 'cui_str': 'Cervical radiculopathy'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C1444662', 'cui_str': 'Discontinued'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0477633', 'cui_str': 'Cervical disc disorder'}]","[{'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}]","[{'cui': 'C0027530', 'cui_str': 'Neck structure'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0027532', 'cui_str': 'Skeletal muscle structure of neck'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}, {'cui': 'C0007859', 'cui_str': 'Neck pain'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}]",106.0,0.221291,"There was a significant improvement in headache intensity 1 year postoperatively in patients with cervical radiculopathy and neck-related headache, but there were no differences between groups over time.","[{'ForeName': 'Jard', 'Initials': 'J', 'LastName': 'Svensson', 'Affiliation': 'aDepartment of Health, Medicine and Caring Sciences, Physiotherapy, Linköping University, Linköping, Sweden bDepartment of Neurosurgery, Linköping University Hospital, Linköping, Sweden cDepartment of Activity and Health, Region Östergötland, Linköping, Sweden dDepartment of Biomedical and Clinical Sciences, Linköping University, Linköping, Sweden eNeuro-Orthopedic Center, Region Jönköping County, Jönköping, Sweden fDivision of Physiotherapy, Department of Neurobiology, Care Sciences and Society, Karolinska Institutet, Stockholm, Sweden gDepartment of Occupational Therapy and Physiotherapy, Allied Health Professionals Function, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Hermansen', 'Affiliation': ''}, {'ForeName': 'Johanna', 'Initials': 'J', 'LastName': 'Wibault', 'Affiliation': ''}, {'ForeName': 'Håkan', 'Initials': 'H', 'LastName': 'Löfgren', 'Affiliation': ''}, {'ForeName': 'Åsa', 'Initials': 'Å', 'LastName': 'Dedering', 'Affiliation': ''}, {'ForeName': 'Birgitta', 'Initials': 'B', 'LastName': 'Öberg', 'Affiliation': ''}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Zsigmond', 'Affiliation': ''}, {'ForeName': 'Anneli', 'Initials': 'A', 'LastName': 'Peolsson', 'Affiliation': ''}]",Spine,['10.1097/BRS.0000000000003430'] 2764,32609523,Effectiveness of resistive vibration exercise and whey protein supplementation plus alkaline salt on the skeletal muscle proteome following 21 days of bedrest in healthy males.,"Muscle atrophy is a deleterious consequence of physical inactivity and is associated with increased morbidity and mortality. The aim of this study was to decipher the mechanisms involved in disuse muscle atrophy in 8 healthy men using 21-day bed rest with a cross-over design (control, with resistive vibration exercise (RVE) or RVE combined with whey protein supplementation and an alkaline salt (NEX)). The main physiological findings show a significant reduction in whole body fat free mass (CON -4.1%, RVE -4.3%, NEX -2.7%, p<0.05), maximal oxygen consumption (CON -20.5%, RVE -6.46%, NEX -7.9%, p<0.05) and maximal voluntary contraction (CON -15%, RVE -12% and NEX -9.5%) (p<0.05) and a reduction in mitochondrial enzyme activity (CON -30.7%, RVE -31.3%, NEX -17%, p<0.05). The benefits of nutrition and exercise countermeasure was evident with an increase in leg lean mass (CON -1.7%, RVE +8.9%, NEX +15%, p<0.05). Changes to the vastus lateralis muscle proteome were characterized using mass spectrometry-based label-free quantitative proteomics, the findings of which suggest alterations to cell metabolism, mitochondrial metabolism, protein synthesis and degradation pathways during bed rest. The observed changes were partially mitigated during RVE but there were no significant pathway changes during the NEX trial. The mass spectrometry proteomics data have been deposited to the ProteomeXchange Consortium with the dataset identifier PXD006882. In conclusion, resistive vibration exercise, when combined with whey/alkalising salt supplementation, could be an effective strategy to prevent skeletal muscle protein changes, muscle atrophy and insulin sensitivity during medium duration bed rest.",2020,"The main physiological findings show a significant reduction in whole body fat free mass (CON -4.1%, RVE -4.3%, NEX -2.7%, p<0.05), maximal oxygen consumption (CON -20.5%, RVE -6.46%, NEX -7.9%, p<0.05) and maximal voluntary contraction (","['21 days of bedrest in healthy males', '8 healthy men using']","['resistive vibration exercise', '21-day bed rest with a cross-over design (control, with resistive vibration exercise (RVE) or RVE combined with whey protein supplementation and an alkaline salt (NEX', 'resistive vibration exercise and whey protein supplementation plus alkaline salt']","['whole body fat free mass', 'mitochondrial enzyme activity', 'maximal voluntary contraction ', 'morbidity and mortality', 'maximal oxygen consumption', 'leg lean mass']","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0004910', 'cui_str': 'Bedrest'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0025266', 'cui_str': 'Man'}]","[{'cui': 'C0455941', 'cui_str': 'Vibration - treatment'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0004910', 'cui_str': 'Bedrest'}, {'cui': 'C0242817', 'cui_str': 'Crossover Design'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0078479', 'cui_str': 'Whey Proteins'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0036140', 'cui_str': 'Salts'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0229960', 'cui_str': 'Entire body as a whole'}, {'cui': 'C0424679', 'cui_str': 'Fat-free mass'}, {'cui': 'C0026237', 'cui_str': 'Mitochondrion'}, {'cui': 'C0243102', 'cui_str': 'enzyme activity'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0439656', 'cui_str': 'Voluntary'}, {'cui': 'C0567116', 'cui_str': 'Finding of uterine contractions'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0030055', 'cui_str': 'Body oxygen consumption'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}]",8.0,0.031534,"The main physiological findings show a significant reduction in whole body fat free mass (CON -4.1%, RVE -4.3%, NEX -2.7%, p<0.05), maximal oxygen consumption (CON -20.5%, RVE -6.46%, NEX -7.9%, p<0.05) and maximal voluntary contraction (","[{'ForeName': 'Helena C', 'Initials': 'HC', 'LastName': 'Kenny', 'Affiliation': ''}, {'ForeName': 'Georg', 'Initials': 'G', 'LastName': 'Tascher', 'Affiliation': ''}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Ziemianin', 'Affiliation': ''}, {'ForeName': 'Floriane', 'Initials': 'F', 'LastName': 'Rudwill', 'Affiliation': ''}, {'ForeName': 'Alexandre', 'Initials': 'A', 'LastName': 'Zahariev', 'Affiliation': ''}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Chery', 'Affiliation': ''}, {'ForeName': 'Guillemette', 'Initials': 'G', 'LastName': 'Gauquelin-Koch', 'Affiliation': ''}, {'ForeName': 'Marie-Pierre', 'Initials': 'MP', 'LastName': 'Barielle', 'Affiliation': ''}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Heer', 'Affiliation': ''}, {'ForeName': 'Stephane', 'Initials': 'S', 'LastName': 'Blanc', 'Affiliation': ''}, {'ForeName': 'Donal J', 'Initials': 'DJ', 'LastName': ""O'Gorman"", 'Affiliation': ''}, {'ForeName': 'Fabrice', 'Initials': 'F', 'LastName': 'Bertile', 'Affiliation': ''}]",Journal of proteome research,['10.1021/acs.jproteome.0c00256'] 2765,32609647,The particulars of certain drugs' effect on the endogenous coenzyme Q10 plasma level in patients with cardiovascular diseases.,"Objectives Coenzyme Q10 (CoQ10) has many vital functions in human body and its endogenous level can be affected either by various diseases or by administrated drugs. This study reveals the effect of atorvastatin, amlodipine and ethoxidol on the endogenous CoQ10 plasma concentration. Methods It was determined the total plasma concentration of endogenous CoQ10 in the plasma of 54 healthy individuals and 62 patients with cardiovascular diseases during treatment with various drugs using high performance liquid chromatography with mass spectrometric detection (HPLC-MS/MS). Results It was found that CoQ10 plasma concentration in patients is statistically significantly lower (on average -49.0 Δ%) than in practically healthy individuals. The total CoQ10 plasma level in patients receiving atorvastatin in the complex therapy is statistically significantly lower (-15.2 Δ%), and in patients taking amlodipine or ethoxidol is statistically significantly higher (+18.2 and + 20.2 Δ%, respectively) than in patients of control groups (a group of patients who receive the same drugs, except for the studied one). Conclusions The study showed that in patients with CVDs treated with various drugs the CoQ10 plasma level is statistically significantly lower than in practically healthy individuals. So, to avoid the adverse reactions connected with low CoQ10 plasma levels, it is recommended to adjust the therapy to maintain its constant level.",2020,It was found that CoQ10 plasma concentration in patients is statistically significantly lower (on average -49.0 Δ%) than in practically healthy individuals.,"['54 healthy individuals and 62 patients with cardiovascular diseases', 'patients with cardiovascular diseases']","['atorvastatin', 'atorvastatin, amlodipine and ethoxidol', 'amlodipine', 'Objectives Coenzyme Q10 (CoQ10']","['total plasma concentration of endogenous CoQ10', 'total CoQ10 plasma level', 'CoQ10 plasma level', 'CoQ10 plasma concentration', 'endogenous coenzyme Q10 plasma level']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}]","[{'cui': 'C0286651', 'cui_str': 'atorvastatin'}, {'cui': 'C0051696', 'cui_str': 'Amlodipine'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0056077', 'cui_str': 'Ubiquinone'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0205227', 'cui_str': 'Endogenous'}, {'cui': 'C0056077', 'cui_str': 'Ubiquinone'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",54.0,0.0159371,It was found that CoQ10 plasma concentration in patients is statistically significantly lower (on average -49.0 Δ%) than in practically healthy individuals.,"[{'ForeName': 'Evgenia', 'Initials': 'E', 'LastName': 'Shikh', 'Affiliation': '2.Sechenov First Moscow State Medical University, Trubetskaya 8, bld. 2, Moscow, 119991, Russian Federation.'}, {'ForeName': 'Vladlena', 'Initials': 'V', 'LastName': 'Zozina', 'Affiliation': 'I M Sechenov First Moscow State Medical University, 8-2 Trubetskaya str., Moscow, 119991, Russian Federation.'}, {'ForeName': 'Svetlana', 'Initials': 'S', 'LastName': 'Kondratenko', 'Affiliation': '2.Sechenov First Moscow State Medical University, Trubetskaya 8, bld. 2, Moscow, 119991, Russian Federation.'}, {'ForeName': 'Evgeny', 'Initials': 'E', 'LastName': 'Melnikov', 'Affiliation': '2.Sechenov First Moscow State Medical University, Trubetskaya 8, bld. 2, Moscow, 119991, Russian Federation.'}, {'ForeName': 'Vladimir', 'Initials': 'V', 'LastName': 'Kukes', 'Affiliation': '2.Sechenov First Moscow State Medical University, Trubetskaya 8, bld. 2, Moscow, 119991, Russian Federation.'}]",Drug metabolism and personalized therapy,['10.1515/dmpt-2020-0106'] 2766,32609648,Self-estimation of phenylketonuria patients on therapeutic diet. Psychological support.,"Objectives Self-esteem is the degree to which the qualities and characteristics contained in one's self-concept are perceived to be positive. The aim of this study was to evaluate the self-esteem scores in phenylketonuria (PKU) patients on ""strict"", ""loos"" and ""off diet"". Sixty PKU patients were divided in three equal groups. Methods Group a: ""on strict"", group b: ""on loos"" and group c: ""off diet"". A special questionnaire for self-esteem scores was created for these patients. Results Before psychological support, group a patients demonstrated 6/20 (30%) very high self-esteem, 9/20 (45%) high and 5/25 (25%) moderate. After support 14/20 (70%) were turned to very high, 5/20 (25%) represented high except one whose degrees remained an altered. group b 4/20 (20%) were very high, 7/20 (35%) were high, 3/20 (15%) moderate and the rest of them showed low self-esteem degrees, after support, 10/20 (50%) showed very high, 5/20 (25%) became high, 3/20 (15%) turned to moderate and 2/20 (10%) remained unaltered. Group c, 1/20 (5%) were very high self-esteemed, 7/20 (35%) were high, 6/20 (30%) were moderate and 6/20 (30%) with low self-esteemed, at the end of support, 6/20 (30%) become very high, 8/20 (40%) with high, 4/20 (20.0%), moderate self-esteem whereas the rest were unaltered. Conclusions Very high and high self-esteem degrees were demonstrated in patients who follow their PKU diet. Moderate and low self-esteem degrees were predominantly found in patients on loos and or off diet. Psychological supports commonly result in amelioration of self-esteem degrees.",2020,Results Before psychological support,"['Sixty PKU patients', 'phenylketonuria (PKU) patients on ""strict"", ""loos"" and ""off diet']","['on loos"" and group c: ""off diet']","['high self-esteem', 'Moderate and low self-esteem degrees', 'moderate self-esteem', 'self-esteem scores']","[{'cui': 'C0031485', 'cui_str': 'Phenylketonuria'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}]","[{'cui': 'C0441837', 'cui_str': 'Group C'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}]","[{'cui': 'C2712312', 'cui_str': 'High self-esteem'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0679136', 'cui_str': 'Low self-esteem'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0036597', 'cui_str': 'Self-esteem'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",60.0,0.0184039,Results Before psychological support,"[{'ForeName': 'Kostas Konstantinos', 'Initials': 'KK', 'LastName': 'Iakovou', 'Affiliation': 'Institute of child health, Inborn Errors of Metabolism, Hivon & Papadiamantopoulou, 15773, Αthens, 11527, Attiki, Greece.'}, {'ForeName': 'Kleopatra', 'Initials': 'K', 'LastName': 'Schulpis', 'Affiliation': 'Institute of Child Health Athens, Inborn error of metabolism, Athens, Attiki, Greece.'}]",Drug metabolism and personalized therapy,['10.1515/dmdi-2020-0107'] 2767,32609651,Can insights from placebo and nocebo mechanisms studies improve the randomized controlled trial?,"Background and aims The randomized controlled trial (RCT) is currently facing several challenges, one of these being that the placebo response appears to be increasing in RCTs, thereby making it difficult to demonstrate an effect of potentially new treatments over placebo. This problem has primarily been approached by predicting the magnitude of the placebo response via stable factors, such as demographic variables, and/or by developing complex designs aimed at reducing the placebo response in the hope that it will improve the test of the active treatment. Yet, the success of this approach has so far been limited. Methods A new approach toward improving the RCT is put forward based on placebo and nocebo mechanism studies, i.e. studies that investigate the mechanisms underlying placebo analgesia and nocebo hyperalgesia. In a series of meta-analyses the magnitude of placebo and nocebo effects were determined. Experimental studies across nociplastic and neuropathic pain conditions and across pharmacological and acupuncture treatments investigated psychological and neurobiological mechanisms underlying these effects. The obtained results were used to make approximations of expectations to see if that could predict the placebo response in RCTs and function as a new way of tapping into the placebo component of treatment effects. Results The magnitude of placebo and nocebo effects is large and highly variable. Placebo effects exist across chronic pain conditions with varying degrees of known etiology as well as across pharmacological and non-pharmacological treatments. Patients' perception of the treatment, the verbal suggestions given for pain relief, and the patients' expectations toward pain relief contribute to the magnitude of the placebo effect and to pain relief following placebo interventions. Also, unintentional unblinding and patients' perception of a treatment markedly influence the treatment outcome. By making approximations of expectations toward treatment effects it was possible to predict the magnitude of the placebo response in RCTs. Conclusions and implications The new approach of tapping into or directly asking patients about their perception and expectations toward a treatment, along with the account of the natural history of pain, has the potential to improve the information that can be obtained from RCTs. Thus, by interfacing insights from placebo and nocebo mechanism studies, it may be possible to enhance the information that can be obtained from RCTs and to account for a large part of the variability in the placebo component of the overall treatment effect. This approach has the potential to improve the scientific evaluation of treatments, as well as to illustrate how the effect of treatments can be optimized in clinical practice, which is the crux of evidence-based medicine.",2020,"Patients' perception of the treatment, the verbal suggestions given for pain relief, and the patients' expectations toward pain relief contribute to the magnitude of the placebo effect and to pain relief following placebo interventions.",[],"['acupuncture', 'Placebo', 'placebo']",['pain relief'],[],"[{'cui': 'C0001299', 'cui_str': 'Acupuncture'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0451615', 'cui_str': 'Pain relief'}]",,0.289856,"Patients' perception of the treatment, the verbal suggestions given for pain relief, and the patients' expectations toward pain relief contribute to the magnitude of the placebo effect and to pain relief following placebo interventions.","[{'ForeName': 'Lene', 'Initials': 'L', 'LastName': 'Vase', 'Affiliation': 'Department of Psychology and Behavioural Sciences, Aarhus University, Bartholins Allé 11, Building 1350, DK-8000 Aarhus C, Denmark.'}]",Scandinavian journal of pain,['10.1515/sjpain-2019-0183'] 2768,32609653,Baseline pain characteristics predict pain reduction after physical therapy in women with chronic pelvic pain. Secondary analysis of data from a randomized controlled trial.,"Background and aims Women with chronic pelvic pain represent a heterogeneous group, and it is suggested that the existence of sub-groups can explain varying results and inconclusiveness in clinical trials. Some predictors of treatment outcome are suggested, but the evidence is limited. The primary aim of this study was to explore if selected pre-treatment characteristics of the participants in a recently conducted randomized controlled trial were associated with treatment outcome. Methods In this study secondary analysis of data collected in a randomized trial were conducted. The participants were women with chronic pelvic pain randomized to two different physical therapy treatments. Analyses in this study were performed for the whole group as a cohort. The primary outcome measure was change in pain intensity from baseline to 12 months, measured with the numeric rating scale (0-10). The women were asked to rate their mean pelvic pain intensity during the last 7 days. Based on previous research and on available variables from the randomized controlled trial four potential predictive factors were derived from the baseline data and assessed one by one in a linear regression model, adjusted for age and treatment group. The variables with strongest association (p < 0.10) with the primary outcome were further included in a multivariable linear regression model with backward selection, adjusted for age and treatment group. Results Fifty women (mean age 38.1, SD = 12.2) were included in the analysis. For these women the mean change in pain intensity was -1.2 points (95% CI -1.8 to -0.7) from baseline to 12 months. The multivariable regression model showed that pelvic pain duration of 6 years or more was associated with less decrease in pain intensity with a regression coefficient of 1.3 (95% CI 0.3-2.4). Baseline pain intensity was associated with higher pain reduction after PT treatment with a regression coefficient per SD increase in baseline pain of -0.6 (95% CI -1.1 to -0.1). None of the women with main pain site other places than in the pelvis reported any pain reduction after physical therapy treatment, but due to the small numbers the predictor was not included in the regression analysis. Conclusions We identified that pelvic pain duration of 6 years or more was associated with less pain reduction, and that higher baseline pain intensity was associated with higher pain reduction after physical therapy treatment in this sample of women with chronic pelvic pain. For the variable main pain site other places than the pelvis the results are unsure due to small numbers. Implications Based on our finding of long pain duration as a negative predictor for pain reduction, we emphasize that early intervention is important. Many of the participants in our RCT reported pelvic surgeries or other treatments prior to referral for PT, and we suggest that referral to a non-invasive intervention such as PT should be considered at an earlier stage. In order to tailor interventions to the individual women's needs, thorough baseline assessments, preferably in a multidisciplinary setting, should be performed.",2020,Baseline pain intensity was associated with higher pain reduction after PT treatment with a regression coefficient per SD increase in baseline pain of -0.6 (95% CI -1.1 to -0.1).,"['Results Fifty women (mean age 38.1, SD\u2009=\u200912.2) were included in the analysis', 'participants were women with chronic pelvic pain randomized to two different', 'women with chronic pelvic pain']","['physical therapy treatments', 'physical therapy']","['pain reduction', 'change in pain intensity', 'pain intensity', 'pelvic pain duration', 'numeric rating scale', 'Baseline pain intensity', 'pelvic surgeries', 'mean pelvic pain intensity']","[{'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0404484', 'cui_str': 'Chronic pelvic pain of female'}]","[{'cui': 'C0949766', 'cui_str': 'Physical therapy procedure'}, {'cui': 'C0031818', 'cui_str': 'Physiotherapy Specialty'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0030794', 'cui_str': 'Pain in pelvis'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0030797', 'cui_str': 'Pelvic'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}]",50.0,0.245129,Baseline pain intensity was associated with higher pain reduction after PT treatment with a regression coefficient per SD increase in baseline pain of -0.6 (95% CI -1.1 to -0.1).,"[{'ForeName': 'Ane S', 'Initials': 'AS', 'LastName': 'Nygaard', 'Affiliation': 'Norwegian National Advisory Unit on Incontinence and Pelvic Floor Health, University Hospital of North Norway, Tromsø, Norway.'}, {'ForeName': 'Gro K', 'Initials': 'GK', 'LastName': 'Haugstad', 'Affiliation': 'Institute of Physical Therapy, Oslo Met-Oslo Metropolitan University, Oslo, Norway.'}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Wilsgaard', 'Affiliation': 'Department of Community Medicine, UiT The Arctic University of Norway, Tromsø, Norway.'}, {'ForeName': 'Pål', 'Initials': 'P', 'LastName': 'Øian', 'Affiliation': 'Department of Obstetrics and Gynecology, University Hospital of North Norway, Tromsø, Norway.'}, {'ForeName': 'Mona', 'Initials': 'M', 'LastName': 'Stedenfeldt', 'Affiliation': ""Norwegian Advisory Unit on Complex Symptom Disorders, St. Olav's Hospital, Trondheim University Hospital, Trondheim, Norway.""}]",Scandinavian journal of pain,['10.1515/sjpain-2020-0026'] 2769,32609733,Sex-related impairment and patient needs/benefits in anogenital psoriasis: Difficult-to-communicate topics and their impact on patient-centred care.,"Genital psoriasis affects 2-5% of psoriasis patients; generalised plaque or intertriginous psoriasis also affects the genital area in 29-40% of cases. Anogenital psoriasis has been associated with significant quality of life impairments, but little is known about specific patient needs/treatment goals. This study aimed to examine the overall and sex-related disease burden, patient needs and treatment benefits in patients with anogenital psoriasis, compared to patients with psoriasis not affecting the anal/genital areas. Within the cross-sectional nationwide survey, 2,009 participants were consecutively recruited in 157 randomly assigned German dermatology practices and clinics, according to the following inclusion criteria aged 18 years or over; diagnosis of psoriasis vulgaris; ability to answer the questionnaires; and written informed consent. Based on a high-resolution grid on the topical distribution of psoriasis, two groups were formed: anogenital psoriasis (n = 622) and comparison group (n = 1,303). Clinical severity was assessed by the Psoriasis Area and Severity Index (PASI). Patients completed the EuroQoL visual analogue scale (EQ VAS), the Dermatology Life Quality Index (DLQI), and the Patient Benefit Index (PBI). Patients with anogenital psoriasis had higher PASI (13.0±10.6 vs. 8.9±7.6, P < 0.001) and more DLQI impairments (8.9±6.9 vs. 7.0±6.2, P = 0.002) than controls. At the item-level, they also reported more sex-related DLQI impairments (DLQI-i9: 0.5±0.8 vs. 0.3±0.7, P < 0.001) and treatment needs (PBI-i17: 2.2±1.8 vs. 1.9±1.8, P = 0.001). A great percentage of missing/not-relevant responses was found for sex-related items (23.3-41.9%). These results suggest that the assessment of sex-related impairments and treatment needs should be prioritised in patients with anogenital psoriasis. Questionnaires may be used as a less uncomfortable way for patients to discuss their genital lesions and sexual function during healthcare visits. However, the great percentage of missing/not-relevant responses to sex-related items calls for in-depth assessments and effective patient-physician communication regarding these sensitive topics.",2020,"Patients with anogenital psoriasis had higher PASI (13.0±10.6 vs. 8.9±7.6, P < 0.001) and more DLQI impairments (8.9±6.9 vs. 7.0±6.2, P = 0.002) than controls.","['2,009 participants were consecutively recruited in 157 randomly assigned German dermatology practices and clinics, according to the following inclusion criteria aged 18 years or over; diagnosis of psoriasis vulgaris', 'patients with anogenital psoriasis, compared to patients with psoriasis not affecting the anal/genital areas', 'patients with anogenital psoriasis']",[],"['Psoriasis Area and Severity Index (PASI', 'PASI', 'EuroQoL visual analogue scale (EQ VAS), the Dermatology Life Quality Index (DLQI), and the Patient Benefit Index (PBI', 'plaque or intertriginous psoriasis', 'DLQI impairments']","[{'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0017477', 'cui_str': 'German language'}, {'cui': 'C0011627', 'cui_str': 'Dermatology'}, {'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0263361', 'cui_str': 'Psoriasis vulgaris'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C4303296', 'cui_str': 'Psoriasis of anogenital region'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0003461', 'cui_str': 'Anal structure'}, {'cui': 'C0017420', 'cui_str': 'Reproductive System'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}]",[],"[{'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0451150', 'cui_str': 'EuroQOL'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0451112', 'cui_str': 'Dermatology life quality index'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0205268', 'cui_str': 'Intertriginous'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}]",2009.0,0.0239389,"Patients with anogenital psoriasis had higher PASI (13.0±10.6 vs. 8.9±7.6, P < 0.001) and more DLQI impairments (8.9±6.9 vs. 7.0±6.2, P = 0.002) than controls.","[{'ForeName': 'Neuza', 'Initials': 'N', 'LastName': 'da Silva', 'Affiliation': 'Institute for Health Services Research in Dermatology and Nursing (IVDP), University Medical Center Hamburg-Eppendorf (UKE), Hamburg, Germany.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Augustin', 'Affiliation': 'Institute for Health Services Research in Dermatology and Nursing (IVDP), University Medical Center Hamburg-Eppendorf (UKE), Hamburg, Germany.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Langenbruch', 'Affiliation': 'Institute for Health Services Research in Dermatology and Nursing (IVDP), University Medical Center Hamburg-Eppendorf (UKE), Hamburg, Germany.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Mrowietz', 'Affiliation': 'Psoriasis-Center, Department of Dermatology, University Medical Center Schleswig-Holstein, Kiel, Germany.'}, {'ForeName': 'Kristian', 'Initials': 'K', 'LastName': 'Reich', 'Affiliation': 'Institute for Health Services Research in Dermatology and Nursing (IVDP), University Medical Center Hamburg-Eppendorf (UKE), Hamburg, Germany.'}, {'ForeName': 'Diamant', 'Initials': 'D', 'LastName': 'Thaçi', 'Affiliation': 'Institute and Comprehensive Centre Inflammation Medicine, University of Lübeck, Lübeck, Germany.'}, {'ForeName': 'Wolf-Henning', 'Initials': 'WH', 'LastName': 'Boehncke', 'Affiliation': 'Division of Dermatology and Venereology, Geneva University Hospitals, Geneva, Switzerland.'}, {'ForeName': 'Natalia', 'Initials': 'N', 'LastName': 'Kirsten', 'Affiliation': 'Institute for Health Services Research in Dermatology and Nursing (IVDP), University Medical Center Hamburg-Eppendorf (UKE), Hamburg, Germany.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Danckworth', 'Affiliation': 'Institute for Health Services Research in Dermatology and Nursing (IVDP), University Medical Center Hamburg-Eppendorf (UKE), Hamburg, Germany.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Sommer', 'Affiliation': 'Institute for Health Services Research in Dermatology and Nursing (IVDP), University Medical Center Hamburg-Eppendorf (UKE), Hamburg, Germany.'}]",PloS one,['10.1371/journal.pone.0235091'] 2770,32609859,Effectiveness of Best Possible Self and Gratitude Writing Intervention on Mental Health Among Parents of Troubled Children.,"The current study was conducted to determine if journaling focused on best possible self and gratitude could improve physiological and mental health outcomes in a sample of affected parents who have teenagers or adult children with emotional and/or behavioral problems. A quasi-experimental, pretest/posttest design was used with blood pressure measure and saliva collection at baseline, after a first journal entry, and after a 6-week journaling intervention. Among 42 parents who completed the pretest, 37 (88.1%) completed the 6-week guided journal and posttest. Findings of paired t tests indicated a statistically significant decrease in stress level (p < 0.001), anxiety (p < 0.001), somatic symptoms (p = 0.001), and depression (p = 0.01), as well as increased gratitude (p = 0.012) among participants. Repeated measures analysis of variance indicated the journaling intervention showed a statistically significant reduction in systolic blood pressure (p = 0.016), but not diastolic blood pressure, or cortisol level at the three testing times. [Journal of Psychosocial Nursing and Mental Health Services, xx(x), xx-xx.].",2020,"Findings of paired t tests indicated a statistically significant decrease in stress level (p < 0.001), anxiety (p < 0.001), somatic symptoms (p = 0.001), and depression (p = 0.01), as well as increased gratitude (p = 0.012) among participants.","['Parents of Troubled Children', 'a sample of affected parents who have teenagers or adult children with emotional and/or behavioral problems', '42 parents who completed the pretest, 37 (88.1%) completed the 6-week guided journal and posttest']",['Best Possible Self and Gratitude Writing Intervention'],"['blood pressure measure and saliva collection', 'anxiety', 'stress level', 'somatic symptoms', 'depression', 'systolic blood pressure', 'diastolic blood pressure, or cortisol level', 'physiological and mental health outcomes', 'Mental Health']","[{'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0683572', 'cui_str': 'Children, Adult'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0233514', 'cui_str': 'Abnormal behavior'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0162443', 'cui_str': 'Journals as Topic'}]","[{'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0332149', 'cui_str': 'Possible'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0036087', 'cui_str': 'Saliva'}, {'cui': 'C0600644', 'cui_str': 'Collection'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C1319127', 'cui_str': 'Level of stress'}, {'cui': 'C3839861', 'cui_str': 'Medically unexplained symptom'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0428883', 'cui_str': 'Diastolic blood pressure'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",42.0,0.0249079,"Findings of paired t tests indicated a statistically significant decrease in stress level (p < 0.001), anxiety (p < 0.001), somatic symptoms (p = 0.001), and depression (p = 0.01), as well as increased gratitude (p = 0.012) among participants.","[{'ForeName': 'YeounSoo', 'Initials': 'Y', 'LastName': 'Kim-Godwin', 'Affiliation': ''}]",Journal of psychosocial nursing and mental health services,['10.3928/02793695-20200624-07'] 2771,32609918,TMJ Arthroscopy with Hyaluronic Acid: A 12-month Randomized Clinical Trial.,"OBJECTIVES To determine the effects of hyaluronic acid (HA) as an adjunct to temporomandibular joint (TMJ) arthroscopy, relative to standard TMJ arthroscopy, in Wilkes stage-III and -IV patients. METHODS A randomized clinical trial design was utilized (ClinicalTrials.gov NCT04110587). The 51 patients were allocated to a TMJ arthroscopy (n = 25) or a TMJ arthroscopy plus HA (n = 26) group. Visual analog scale joint pain scores, maximum mouth opening (MMO), and muscle pain were measured at baseline, and at 3, 6, 9, and 12 months. Disc position on magnetic resonance imaging was evaluated at baseline and 12 months. Oral-health-related quality of life (OHRQoL) was assessed at baseline, and at 6 and 12 months. RESULTS No group differences were observed in clinical or radiographic measurements (P≥0.05). The results do not indicate any benefit of hyaluronic acid as an adjuvant therapy to arthroscopy during follow-up months 3-12. TMJ arthroscopy improved OHRQoL at 6 and 12 months (Oral Health Impact Profile-14 questionnaire scores of -14.59 and -14.27, 95% confidence intervals = -17.55 to -11.63 and -17.27 to -11.27) respectively, as well as pain and MMO, at all follow-up time points (P<0.001). CONCLUSIONS A beneficial effect of HA injection during TMJ arthroscopy after the 3-month follow-up was not observed.",2020,"TMJ arthroscopy improved OHRQoL at 6 and 12 months (Oral Health Impact Profile-14 questionnaire scores of -14.59 and -14.27, 95% confidence intervals = -17.55 to -11.63 and -17.27 to -11.27) respectively, as well as pain and MMO, at all follow-up time points (P<0.001). ","['51 patients', 'Wilkes stage-III and -IV patients']","['TMJ arthroscopy plus HA', 'hyaluronic acid (HA', 'hyaluronic acid', 'HA injection', 'TMJ arthroscopy', 'TMJ Arthroscopy with Hyaluronic Acid']","['Oral-health-related quality of life (OHRQoL', 'Visual analog scale joint pain scores, maximum mouth opening (MMO), and muscle pain', 'pain and MMO', 'clinical or radiographic measurements', 'TMJ arthroscopy improved OHRQoL at 6 and 12 months (Oral Health Impact Profile-14 questionnaire scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3'}]","[{'cui': 'C0039493', 'cui_str': 'Temporomandibular joint structure'}, {'cui': 'C0003904', 'cui_str': 'Arthroscopy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0020196', 'cui_str': 'hyaluronic acid'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0003862', 'cui_str': 'Joint pain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0240379', 'cui_str': 'Open mouth'}, {'cui': 'C0231528', 'cui_str': 'Muscle pain'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0039493', 'cui_str': 'Temporomandibular joint structure'}, {'cui': 'C0003904', 'cui_str': 'Arthroscopy'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",51.0,0.352357,"TMJ arthroscopy improved OHRQoL at 6 and 12 months (Oral Health Impact Profile-14 questionnaire scores of -14.59 and -14.27, 95% confidence intervals = -17.55 to -11.63 and -17.27 to -11.27) respectively, as well as pain and MMO, at all follow-up time points (P<0.001). ","[{'ForeName': 'Oscar Gabriel', 'Initials': 'OG', 'LastName': 'Castaño-Joaqui', 'Affiliation': 'Department of Conservative Dentistry and Bucofacial Prosthesis, Complutense University of Madrid, Pza. Ramón y Cajal, s/n, 28040, Madrid, Spain.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Cano-Sánchez', 'Affiliation': 'Department of Medicine and Orofacial Surgery, Complutense University of Madrid, Pza. Ramón y Cajal, s/n, 28040, Madrid, Spain.'}, {'ForeName': 'Julián', 'Initials': 'J', 'LastName': 'Campo-Trapero', 'Affiliation': 'Department of Medicine and Orofacial Surgery, Complutense University of Madrid, Pza. Ramón y Cajal, s/n, 28040, Madrid, Spain.'}, {'ForeName': 'Mario Fernando', 'Initials': 'MF', 'LastName': 'Muñoz-Guerra', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, University Hospital of La Princesa, Calle de Diego de León, 62, 28006, Madrid, Spain.'}]",Oral diseases,['10.1111/odi.13524'] 2772,32609946,Nasal high-frequency percussive ventilation versus nasal continuous positive airway pressure in newborn infants respiratory distress: a cross over clinical trial.,"OBJECTIVE To determine if nasal high-frequency percussive ventilation (nHFPV) to manage neonatal respiratory distress decreases the regional cerebral oxygen saturation (rScO 2 ) compared to nasal CPAP. STUDY DESIGN A prospective, randomized, monocentric, open-label, non-inferiority crossover trial. Newborns of gestational age (GA) ≥ 33 weeks exhibiting persistent respiratory distress after 10 min of life were treated with nHFPV and nCPAP, in succession and in random order. The primary endpoint was the mean rScO 2 , as revealed by near-infrared spectroscopy (NIRS). RESULTS Forty-nine newborns were randomized; the mean GA and birth weight were 36.4 ± 1.9 weeks and 2,718 ± 497 g. The mean rScO 2 difference during the last 5 min of each ventilation mode (nHFPV minus nCPAP) was -0.7 ± 5.4% (95% CI -2.25; 0.95%). CONCLUSION In our study on newborns of GA ≥ 33 weeks treated for respiratory distress, cerebral oxygenation via nHFPV was not inferior to nCPAP. This article is protected by copyright. All rights reserved.",2020,"In our study on newborns of GA ≥ 33 weeks treated for respiratory distress, cerebral oxygenation via nHFPV was not inferior to nCPAP.","['Forty-nine newborns were randomized; the mean GA and birth weight were 36.4 ± 1.9 weeks and 2,718 ± 497 g', 'newborn infants respiratory distress', 'Newborns of gestational age (GA']","['nHFPV and nCPAP', 'nasal high-frequency percussive ventilation (nHFPV', 'Nasal high-frequency percussive ventilation versus nasal continuous positive airway pressure']","['respiratory distress, cerebral oxygenation via nHFPV', 'mean rScO 2 , as revealed by near-infrared spectroscopy (NIRS', 'regional cerebral oxygen saturation (rScO 2 ', 'respiratory distress']","[{'cui': 'C0021289', 'cui_str': 'Newborn'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0005612', 'cui_str': 'Birth weight'}, {'cui': 'C4517517', 'cui_str': '1.9'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0476273', 'cui_str': 'Respiratory distress'}]","[{'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0205212', 'cui_str': 'High frequency'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C1258045', 'cui_str': 'nCPAP Ventilation'}]","[{'cui': 'C0476273', 'cui_str': 'Respiratory distress'}, {'cui': 'C0006104', 'cui_str': 'Brain structure'}, {'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0205212', 'cui_str': 'High frequency'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0443289', 'cui_str': 'Revealed'}, {'cui': 'C0376519', 'cui_str': 'Near-infrared spectroscopy'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C4273907', 'cui_str': 'Cerebral oxygen saturation'}]",49.0,0.114114,"In our study on newborns of GA ≥ 33 weeks treated for respiratory distress, cerebral oxygenation via nHFPV was not inferior to nCPAP.","[{'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Renesme', 'Affiliation': 'Neonatal Intensive Care Unit, University Hospital of Bordeaux, France.'}, {'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Dumas de la Roque', 'Affiliation': 'Neonatal Intensive Care Unit, University Hospital of Bordeaux, France.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Germain', 'Affiliation': 'Pôle de Santé Publique, Clinical Epidemiology Unit, University Hospital of Bordeaux, France.'}, {'ForeName': 'Agnès', 'Initials': 'A', 'LastName': 'Chevrier', 'Affiliation': 'Neonatal Intensive Care Unit, University Hospital of Bordeaux, France.'}, {'ForeName': 'Muriel', 'Initials': 'M', 'LastName': 'Rebola', 'Affiliation': 'Neonatal Intensive Care Unit, University Hospital of Bordeaux, France.'}, {'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Cramaregeas', 'Affiliation': 'Neonatal Intensive Care Unit, University Hospital of Bordeaux, France.'}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Benard', 'Affiliation': 'Pôle de Santé Publique, Clinical Epidemiology Unit, University Hospital of Bordeaux, France.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Elleau', 'Affiliation': 'Neonatal Intensive Care Unit, University Hospital of Bordeaux, France.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Tandonnet', 'Affiliation': 'Neonatal Intensive Care Unit, University Hospital of Bordeaux, France.'}]",Pediatric pulmonology,['10.1002/ppul.24935'] 2773,32609960,"The SNAP 101 Double-Blind, Placebo/Active-Controlled, Safety, Pharmacokinetic, and Pharmacodynamic Study of INP105 (Nasal Olanzapine) in Healthy Adults.","OBJECTIVE INP105 is a drug-device combination of olanzapine and technology that delivers a powder formulation of olanzapine to the vascular-rich upper nasal space. This study evaluated the pharmacokinetics, pharmacodynamics, safety, and tolerability of single ascending doses of INP105, olanzapine intramuscular (OLZ IM), and olanzapine oral disintegrating tablet (OLZ ODT). METHODS This was a phase 1, active and double-blind placebo comparator-controlled, ascending-dose, 2-period, incomplete-block, 1-way crossover study in 40 healthy subjects, randomized to single doses of OLZ IM (5 or 10 mg) or OLZ ODT (10 mg) in Period 1 and then 1 of 3 doses (5 mg, 10 mg, or 15 mg) of INP105 or placebo in Period 2 between July and October 2018. Sedation and attention were evaluated by visual analog scale (VAS), the Agitation/Calmness Evaluation Scale (ACES), and the Digit Symbol Substitution Test (DSST). RESULTS At equivalent doses, INP105 provided similar area under the drug concentration-time curve (AUC) from time 0 to the last measurable concentration, AUC from time 0 to infinity, and maximum observed concentration (Cmax) as OLZ IM and greater Cmax than but similar AUCs to OLZ ODT. Median time to maximum concentration was less for INP105 (15, 10, and 9.5 min for 5 mg, 10 mg, and 15 mg, respectively) than for OLZ IM (20 and 15 min for 5 mg and 10 mg, respectively) or OLZ ODT (120 min). Effects as measured with the VAS, ACES, and DSST with INP105 5 mg were comparable to those with OLZ IM 5 mg, with earlier onset for INP105 10 mg and 15 mg and greater effects than placebo and OLZ ODT. The incidence of treatment-emergent adverse events with INP105 5 mg, 10 mg, and 15 mg was 80%, 66.7%, and 75%, respectively, compared to 90% and 100% for OLZ IM 5 mg and 10 mg, respectively, and 83.3% for OLZ ODT; most common were dizziness, hypotension, and orthostatic symptoms. CONCLUSIONS INP105 has rapid absorption and pharmacodynamic effects and may represent an effective, convenient, noninvasive, and well-tolerated alternative for treating acutely agitated patients by self- or caregiver administration in the home, community, or hospital environments. TRIAL REGISTRATION ClinicalTrials.gov identifier: NCT03624322.",2020,"At equivalent doses, INP105 provided similar area under the drug concentration-time curve (AUC) from time 0 to the last measurable concentration, AUC from time 0 to infinity, and maximum observed concentration (Cmax) as OLZ IM and greater Cmax than but similar AUCs to OLZ ODT.","['Healthy Adults', '40 healthy subjects']","['olanzapine', 'OLZ ODT', 'INP105, olanzapine intramuscular (OLZ IM), and olanzapine oral disintegrating tablet (OLZ ODT', 'OLZ IM', 'INP105', 'INP105 or placebo', 'INP105 (Nasal Olanzapine', 'placebo']","['Median time to maximum concentration', 'incidence of treatment-emergent adverse events', 'dizziness, hypotension, and orthostatic symptoms', 'visual analog scale (VAS), the Agitation/Calmness Evaluation Scale (ACES), and the Digit Symbol Substitution Test (DSST', 'pharmacokinetics, pharmacodynamics, safety, and tolerability', 'INP105 provided similar area under the drug concentration-time curve (AUC', 'rapid absorption and pharmacodynamic effects']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0171023', 'cui_str': 'olanzapine'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0442117', 'cui_str': 'Intramuscular'}, {'cui': 'C0991504', 'cui_str': 'Disintegrating Oral Tablet'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0020649', 'cui_str': 'Low blood pressure'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0085631', 'cui_str': 'Feeling agitated'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0582802', 'cui_str': 'Digit structure'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0237442', 'cui_str': 'Physiological Absorption'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",40.0,0.158513,"At equivalent doses, INP105 provided similar area under the drug concentration-time curve (AUC) from time 0 to the last measurable concentration, AUC from time 0 to infinity, and maximum observed concentration (Cmax) as OLZ IM and greater Cmax than but similar AUCs to OLZ ODT.","[{'ForeName': 'Stephen B', 'Initials': 'SB', 'LastName': 'Shrewsbury', 'Affiliation': 'Stephen B. Shrewsbury, Impel NeuroPharma, Inc, 201 Elliott Ave West, Ste 260, Seattle, WA 98119. sshrewsbury@impelnp.com.'}, {'ForeName': 'Jasna', 'Initials': 'J', 'LastName': 'Hocevar-Trnka', 'Affiliation': 'Impel NeuroPharma, Inc, Seattle, Washington, USA.'}, {'ForeName': 'Kelsey H', 'Initials': 'KH', 'LastName': 'Satterly', 'Affiliation': 'Impel NeuroPharma, Inc, Seattle, Washington, USA.'}, {'ForeName': 'Karen L', 'Initials': 'KL', 'LastName': 'Craig', 'Affiliation': 'Impel NeuroPharma, Inc, Seattle, Washington, USA.'}, {'ForeName': 'Jason D', 'Initials': 'JD', 'LastName': 'Lickliter', 'Affiliation': 'Nucleus Network, Melbourne, Australia.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Hoekman', 'Affiliation': 'Impel NeuroPharma, Inc, Seattle, Washington, USA.'}]",The Journal of clinical psychiatry,['10.4088/JCP.19m13086'] 2774,32617424,Development and evaluation of an augmented reality education program for pediatric research.,"Background Children often have limited understanding of clinical research and what they might expect from participating in a clinical study. Studies, however, suggest that multimedia delivery of medical and research information may promote greater understanding and engagement compared with standard written approaches. Aim This study was designed to examine the effects of a novel interactive augmented reality (AR) program on children's understanding of clinical research. Methods Children (ages 7-13 years) were randomized to receive the basic information about clinical research using either a printed storybook (control) or the same storybook enhanced using a video see-through AR iPad program (AR) with embedded interactive quizzes. Children were interviewed to assess their understanding of the material before (pre-test) and after (post-test) receiving either of the randomized interventions. Both parents and children completed short surveys to measure their perceptions of the information delivery. Results Ninety-one parent/child dyads were included in the analysis. There were no differences between the control and AR children's pre-test understanding of the research information. However, both groups demonstrated significant and similar improvements in post-test understanding. Parents of children in the AR group found the information to be of higher quality and greater clarity compared with the control group, and 91.7% of children in the AR group found the inclusion of interactive quizzes to be helpful. Both parents and children found the AR program very easy to use and 85.0 % and 71.2%, respectively, indicated that if recruited for a future study that they would prefer information delivered using some type of iPad AR program together with a discussion with the researcher. Conclusions Results demonstrated the importance of providing children and parents with information in an easy to read and visually compelling manner. Although both groups demonstrated improved understanding, children and their parents preferred the AR program and reported a preference for receiving information using computer-based technology. Given the seemingly insurmountable challenge of keeping children and families engaged in health research related information exchange, the use of AR would appear to provide a novel and effective vehicle for enhancing children's and parents assimilation and understanding of research (and medical) information and as a potential tool to optimize the informed consent and assent processes. Relevance for patients This study reinforces the importance in providing information to research participants and patients in an easy-to-read and visually salient manner. Although the AR program used in this study did not result in an increased level of understanding, AR was deemed the preferred method of information delivery. It is hoped that the results of this study will serve as a platform for future studies.",2020,"Parents of children in the AR group found the information to be of higher quality and greater clarity compared with the control group, and 91.7% of children in the AR group found the inclusion of interactive quizzes to be helpful.","[""children's understanding of clinical research"", 'Methods\n\n\nChildren (ages 7-13 years', 'research participants and patients in an easy-to-read and visually salient manner', 'Ninety-one parent/child dyads', 'patients']","['basic information about clinical research using either a printed storybook (control) or the same storybook enhanced using a video see-through AR iPad program (AR) with embedded interactive quizzes', 'novel interactive augmented reality (AR) program']",['higher quality and greater clarity'],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332219', 'cui_str': 'Easy'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C3816959', 'cui_str': '90'}, {'cui': 'C0030551', 'cui_str': 'Parent'}]","[{'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0033161', 'cui_str': 'Printing'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C5197824', 'cui_str': 'Mixed Reality'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0205314', 'cui_str': 'New'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0205393', 'cui_str': 'Most'}, {'cui': 'C0486588', 'cui_str': 'Clarity (property)'}]",,0.0172178,"Parents of children in the AR group found the information to be of higher quality and greater clarity compared with the control group, and 91.7% of children in the AR group found the inclusion of interactive quizzes to be helpful.","[{'ForeName': 'Alan R', 'Initials': 'AR', 'LastName': 'Tait', 'Affiliation': 'Department of Anesthesiology, Michigan Institute for Clinical and Health Research, Michigan Medicine, and ALTality Inc., Ann Arbor, MI, USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Connally', 'Affiliation': 'Department of Michigan Institute for Clinical and Health Research, Michigan Medicine, and ALTality Inc., Ann Arbor, MI, USA.'}, {'ForeName': 'Aalap', 'Initials': 'A', 'LastName': 'Doshi', 'Affiliation': 'Department of Michigan Institute for Clinical and Health Research, Michigan Medicine, and ALTality Inc., Ann Arbor, MI, USA.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Johnson', 'Affiliation': 'Department of Michigan Institute for Clinical and Health Research, Michigan Medicine, and ALTality Inc., Ann Arbor, MI, USA.'}, {'ForeName': 'Abbey', 'Initials': 'A', 'LastName': 'Skrzpek', 'Affiliation': 'Department of Michigan Institute for Clinical and Health Research, Michigan Medicine, and ALTality Inc., Ann Arbor, MI, USA.'}, {'ForeName': 'Mashala', 'Initials': 'M', 'LastName': 'Grimes', 'Affiliation': 'Department of Anesthesiology, Michigan Institute for Clinical and Health Research, Michigan Medicine, and ALTality Inc., Ann Arbor, MI, USA.'}, {'ForeName': 'Asif', 'Initials': 'A', 'LastName': 'Becher', 'Affiliation': 'Department of Anesthesiology, Michigan Institute for Clinical and Health Research, Michigan Medicine, and ALTality Inc., Ann Arbor, MI, USA.'}, {'ForeName': 'Jae Eun', 'Initials': 'JE', 'LastName': 'Choi', 'Affiliation': 'Department of ALTality Inc., Ann Arbor, MI, USA.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Weber', 'Affiliation': 'Department of Anesthesiology, Michigan Institute for Clinical and Health Research, Michigan Medicine, and ALTality Inc., Ann Arbor, MI, USA.'}]",Journal of clinical and translational research,[] 2775,32617429,Implementation of a randomized controlled trial on an inpatient stroke rehabilitation unit: Lessons learned.,"Background/Aims The objective of this manuscript is to present challenges and solutions that arose during a mid-sized single-site RCT of a rehabilitation intervention performed in an inpatient stroke rehabilitation setting. Methods Seventy-six participants from an inpatient stroke rehabilitation unit were randomized to experimental and control groups. All participants did 30-45 min of virtual reality (VR) daily for 10-12 sessions. The experimental group did VR targeting sitting balance while the control group did VR with limited arm movement. Challenges during the implementation of the RCT were documented and strategies to mitigate them were applied. Results Challenges were placed into five categories:1. Recruitment. Our recruitment procedures required multiple steps prior to initiating direct patient contact; one solution would be to have patients consent to be approached about research upon admission to the inpatient unit.2. Patient-specific Issues. Fatigue, pain, vision problems and engagement were managed through scheduling, increasing the workload slowly and personalized modifications to the VR.3./4. Scheduling and Staffing. Recruitment and attendance at VR sessions were maximized through good communication, flexibility and cooperation, between research staff, clinical staff, volunteers, students and participants.5. Technology. Because hospital internet service was poor, a mobile internet data plan was purchased to ensure the system's reliability. Conclusions We have identified challenges in delivering a rehabilitation intervention on an inpatient stroke rehabilitation unit and some of the measures taken to surmount these challenges. Through good planning, flexibility and collaboration, almost all of the challenges were successfully addressed. Clinical trial registration number URL: http://www.clinicaltrials.gov. Unique identifier: NCT02285933.",2020,"Fatigue, pain, vision problems and engagement were managed through scheduling, increasing the workload slowly and personalized modifications to the VR.3./4.",['Methods\n\n\nSeventy-six participants from an inpatient stroke rehabilitation unit'],[],"['Fatigue, pain, vision problems and engagement', 'VR targeting sitting balance']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4319622', 'cui_str': '76'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0204097', 'cui_str': 'Stroke rehabilitation'}, {'cui': 'C0439148', 'cui_str': 'Unit'}]",[],"[{'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C3665347', 'cui_str': 'Visual impairment'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0516712', 'cui_str': 'Balancing when sitting'}]",76.0,0.0245261,"Fatigue, pain, vision problems and engagement were managed through scheduling, increasing the workload slowly and personalized modifications to the VR.3./4.","[{'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Sheehy', 'Affiliation': 'Bruyère Research Institute, Ottawa, Canada.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Taillon-Hobson', 'Affiliation': 'Bruyère Research Institute, Ottawa, Canada.'}, {'ForeName': 'Heidi', 'Initials': 'H', 'LastName': 'Sveistrup', 'Affiliation': 'Bruyère Research Institute, Ottawa, Canada.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Bilodeau', 'Affiliation': 'Bruyère Research Institute, Ottawa, Canada.'}, {'ForeName': 'Hillel', 'Initials': 'H', 'LastName': 'Finestone', 'Affiliation': 'Bruyère Research Institute, Ottawa, Canada.'}]",Contemporary clinical trials communications,['10.1016/j.conctc.2020.100563'] 2776,32617431,Increasing the power of randomized trials comparing different treatment durations.,"When the optimal treatment duration is uncertain, a randomized trial may allocate patients to receive active treatment for different durations. We use an example where patients receive treatment for 0, 24, or 52 weeks. In this trial, patients in the 24-weeks and 52-weeks arms receive the same treatment during the first 24 weeks. This overlap allows for more powerful analyses than conventional pair-wise comparisons of arms. When the outcome is the time-to-event, the power for the 0-weeks versus 24-weeks comparison can be increased by including patients in the 52-weeks arm as patients in the 24-weeks arm for the first 24 weeks and censoring at 24 weeks. Furthermore, differences observed between the 24-weeks and 52-weeks arms during the first 24 weeks can only reflect noise. Hence, the comparison of these two arms should be restricted to only patients who remain on the study at 24 weeks and include only the events after 24 weeks. Through simulation, we show that modified analyses accounting for these considerations increase study power substantially. Moreover, if patients were allocated equally to the arms, then events or discontinuations during the first 24 weeks will reduce the number of patients available for the 24-weeks versus 52-weeks comparison, and hence the power of this analysis will be lower than that for the 0-weeks versus 24-weeks comparison. We present a sample size calculation procedure for equalizing the power of these two analyses. Typically, this allocation requires much larger sample sizes in the 24-weeks and 52-weeks arms than in the 0-week arm.",2020,"Typically, this allocation requires much larger sample sizes in the 24-weeks and 52-weeks arms than in the 0-week arm.",[],[],[],[],[],[],,0.0437104,"Typically, this allocation requires much larger sample sizes in the 24-weeks and 52-weeks arms than in the 0-week arm.","[{'ForeName': 'Yongdong', 'Initials': 'Y', 'LastName': 'Ouyang', 'Affiliation': 'School of Population and Public Health, University of British Columbia, 2206 East Mall, Vancouver, BC, V6T 1Z3, Canada.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Qian', 'Affiliation': ""Centre for Health Evaluation and Outcome Sciences, 588-1081 Burrard Street, St Paul's Hospital, Vancouver, BC, V6Z 1Y6, Canada.""}, {'ForeName': 'Lakshmi N', 'Initials': 'LN', 'LastName': 'Yatham', 'Affiliation': 'Department of Psychiatry, The University of British Columbia, 2255 Wesbrook Mall, Vancouver, BC, V6T 2A1, Canada.'}, {'ForeName': 'Hubert', 'Initials': 'H', 'LastName': 'Wong', 'Affiliation': 'School of Population and Public Health, University of British Columbia, 2206 East Mall, Vancouver, BC, V6T 1Z3, Canada.'}]",Contemporary clinical trials communications,['10.1016/j.conctc.2020.100588'] 2777,32617434,"HAMAMATSU-ICG study: Protocol for a phase III, multicentre, single-arm study to assess the usefulness of indocyanine green fluorescent lymphography in assessing secondary lymphoedema.","Introduction Secondary lymphoedema of the extremities is an important quality-of-life issue for patients who were treated for their malignancies. Indocyanine green (ICG) fluorescent lymphography may be helpful for assessing lymphoedema and for planning lymphaticovenular anastomosis (LVA). The objective of the present clinical trial is to confirm whether or not ICG fluorescent lymphography using the near-infrared monitoring camera is useful for assessing the indication for LVA, for the identification of the lymphatic vessels before the conduct of LVA, and for the confirmation of the patency of the anastomosis site during surgery. Methods and analysis This trial is a phase III, multicentre, single-arm, open-label clinical trial to assess the efficacy and safety of ICG fluorescent lymphography when assessing and treating lymphoedema of patients with secondary lymphoedema who are under consideration for LVA. The primary endpoint is the identification rate of the lymphatic vessels at the incision site based on ICG fluorescent lymphograms obtained before surgery. The secondary endpoints are 1) the sensitivity and specificity of dermal back flow determined by ICG fluorescent lymphography as compared with 99m Tc lymphoscintigraphy-one of the standard diagnostic methods and 2) the usefulness of ICG fluorescent lymphography when confirming the patency of the anastomosis site after LVA. Ethics and dissemination The protocol for the study was approved by the Institutional Review Board of each institution. The trial was filed for and registered at the Pharmaceuticals and Medical Devices Agency in Japan. The trial is currently on-going and is scheduled to end in June 2020. Trial registration number jRCT2031190064; Pre-results.",2020,The primary endpoint is the identification rate of the lymphatic vessels at the incision site based on ICG fluorescent lymphograms obtained before surgery.,"['patients with secondary lymphoedema who are under consideration for LVA', 'patients who were treated for their malignancies']","['ICG fluorescent lymphography', 'indocyanine green fluorescent lymphography', 'Indocyanine green (ICG) fluorescent lymphography']","['sensitivity and specificity of dermal back flow determined by ICG fluorescent lymphography', 'identification rate of the lymphatic vessels at the incision site based on ICG fluorescent lymphograms obtained before surgery']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0265191', 'cui_str': 'Chronic acquired lymphedema'}, {'cui': 'C1272681', 'cui_str': 'Under consideration'}, {'cui': 'C0332853', 'cui_str': 'Anastomosis'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}]","[{'cui': 'C0021234', 'cui_str': 'Indocyanine Green'}, {'cui': 'C0303920', 'cui_str': 'Fluorescent stain'}, {'cui': 'C0024219', 'cui_str': 'Lymphangiogram'}]","[{'cui': 'C0036668', 'cui_str': 'Sensitivity and Specificity'}, {'cui': 'C1522447', 'cui_str': 'Cutaneous route'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0021234', 'cui_str': 'Indocyanine Green'}, {'cui': 'C0303920', 'cui_str': 'Fluorescent stain'}, {'cui': 'C0024219', 'cui_str': 'Lymphangiogram'}, {'cui': 'C0020792', 'cui_str': 'Identification - mental defense mechanism'}, {'cui': 'C0229889', 'cui_str': 'Structure of lymphatic vessel'}, {'cui': 'C0449681', 'cui_str': 'Site of incision'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}]",,0.0886615,The primary endpoint is the identification rate of the lymphatic vessels at the incision site based on ICG fluorescent lymphograms obtained before surgery.,"[{'ForeName': 'Shinsuke', 'Initials': 'S', 'LastName': 'Akita', 'Affiliation': 'Department of Plastic, Reconstructive, and Aesthetic Surgery, Chiba University Graduate School of Medicine, Chiba, Japan.'}, {'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Unno', 'Affiliation': 'Department of Vascular Surgery, Hamamatsu Medical Center, Hamamatsu, Japan.'}, {'ForeName': 'Jiro', 'Initials': 'J', 'LastName': 'Maegawa', 'Affiliation': 'Department of Plastic and Reconstructive Surgery, Yokohama City University, Graduate School of Medicine, Yokohama, Japan.'}, {'ForeName': 'Yoshihiro', 'Initials': 'Y', 'LastName': 'Kimata', 'Affiliation': 'Department of Plastic and Reconstructive Surgery, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Science, Okayama, Japan.'}, {'ForeName': 'Hidekazu', 'Initials': 'H', 'LastName': 'Fukamizu', 'Affiliation': 'Department of Plastic and Reconstructive Surgery, Hamamatsu University School of Medicine, Hamamatsu, Japan.'}, {'ForeName': 'Yuichiro', 'Initials': 'Y', 'LastName': 'Yabuki', 'Affiliation': 'Department of Plastic and Reconstructive Surgery, Yokohama City University, Graduate School of Medicine, Yokohama, Japan.'}, {'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Shinaoka', 'Affiliation': 'Department of Plastic and Reconstructive Surgery, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Science, Okayama, Japan.'}, {'ForeName': 'Masaki', 'Initials': 'M', 'LastName': 'Sano', 'Affiliation': 'Second Department of Surgery, Hamamatsu University School of Medicine, Hamamatsu, Japan.'}, {'ForeName': 'Yohei', 'Initials': 'Y', 'LastName': 'Kawasaki', 'Affiliation': 'Clinical Research Center, Chiba University Hospital, Chiba, Japan.'}, {'ForeName': 'Tadami', 'Initials': 'T', 'LastName': 'Fujiwara', 'Affiliation': 'Clinical Research Center, Chiba University Hospital, Chiba, Japan.'}, {'ForeName': 'Hideki', 'Initials': 'H', 'LastName': 'Hanaoka', 'Affiliation': 'Clinical Research Center, Chiba University Hospital, Chiba, Japan.'}, {'ForeName': 'Nobuyuki', 'Initials': 'N', 'LastName': 'Mitsukawa', 'Affiliation': 'Department of Plastic, Reconstructive, and Aesthetic Surgery, Chiba University Graduate School of Medicine, Chiba, Japan.'}]",Contemporary clinical trials communications,['10.1016/j.conctc.2020.100595'] 2778,32617435,Body therapy versus treatment as usual among Danish veterans with PTSD: Study protocol for a randomised controlled trial combined with a qualitative study.,"Background Many veterans suffer from Post-Traumatic Stress Disorder (PTSD) after returning from military missions. This implies complex physical and psychosocial problems for veterans and their families. Treatment options today are primarily medically and psychologically founded but treatment response is incomplete. Body therapy for PTSD is scarcely researched though subject of increased attention. In 2015, a Danish pilot study was conducted exploring body therapy for PTSD. The study showed positive results and formed basis for a randomised controlled trial. This paper outlines the protocol for this trial. Methods The intervention will be evaluated in a two-arm randomised controlled trial (1:1). The trial will include 42 veterans with PTSD recruited by the Danish Military Psychiatric Centre. The intervention group receives treatment as usual and weekly body therapy treatment as add-on. The control group receives treatment as usual (TAU). Participants will complete four questionnaires assessing PTSD, depression, quality of life, function level and body awareness: at baseline, and at 3 months, 6 months and 12 months post baseline. Linear regression models and mixed effects models will be used to assess intervention effects. Furthermore, an ethnographic study will examine how the participants experience the treatment and changes in their everyday life. The ethnographic study is based on in-depth interviews, participant observations and focus groups. A mixed method, convergent parallel design will be applied. Discussion This study examines the efficacy of body therapy for veterans with PTSD and how the treatment is experienced and affects daily life. The study will contribute with important knowledge on an alternative treatment for PTSD. Trial registration ClinicalTrials.gov Identifier: NCT03777800.",2020,"Participants will complete four questionnaires assessing PTSD, depression, quality of life, function level and body awareness: at baseline, and at 3 months, 6 months and 12 months post baseline.","['veterans with PTSD', 'veterans and their families', '42 veterans with PTSD recruited by the Danish Military Psychiatric Centre', 'veterans suffer from Post-Traumatic Stress Disorder (PTSD) after returning from military missions', 'Danish veterans with PTSD']",['Body therapy'],"['questionnaires assessing PTSD, depression, quality of life, function level and body awareness']","[{'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0010969', 'cui_str': 'Danish language'}, {'cui': 'C0026126', 'cui_str': 'Military personnel'}, {'cui': 'C0033873', 'cui_str': 'Psychiatry'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0026219', 'cui_str': 'Missions'}]","[{'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0038436', 'cui_str': 'Posttraumatic stress disorder'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}]",,0.0647287,"Participants will complete four questionnaires assessing PTSD, depression, quality of life, function level and body awareness: at baseline, and at 3 months, 6 months and 12 months post baseline.","[{'ForeName': 'Nanna Gram', 'Initials': 'NG', 'LastName': 'Ahlmark', 'Affiliation': 'National Institute of Public Health, University of Southern Denmark, Studiestræde 6, DK-1455, Copenhagen, Denmark.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Dahl', 'Affiliation': 'National Institute of Public Health, University of Southern Denmark, Studiestræde 6, DK-1455, Copenhagen, Denmark.'}, {'ForeName': 'Henrik Steen', 'Initials': 'HS', 'LastName': 'Andersen', 'Affiliation': 'Danish Military Psychiatric Center, Capital Region of Denmark, Blegdamsvej 9, DK-2100, Copenhagen, Denmark.'}, {'ForeName': 'Tine', 'Initials': 'T', 'LastName': 'Tjørnhøj-Thomsen', 'Affiliation': 'National Institute of Public Health, University of Southern Denmark, Studiestræde 6, DK-1455, Copenhagen, Denmark.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Andersen', 'Affiliation': 'National Institute of Public Health, University of Southern Denmark, Studiestræde 6, DK-1455, Copenhagen, Denmark.'}]",Contemporary clinical trials communications,['10.1016/j.conctc.2020.100596'] 2779,32617582,Treatment of fibrillary glomerulonephritis with rituximab: a 12-month pilot study.,"BACKGROUND Fibrillary glomerulonephritis (FGN) is a rare type of glomerulonephritis with poor prognosis, with no known effective therapies available for treatment. The objective of the study was to evaluate the efficacy and safety of rituximab in treatment of patients with FGN and to investigate the effect of rituximab on DNAJB9 levels. METHODS This was a pilot prospective clinical trial in which patients with idiopathic FGN were treated with two courses of rituximab (1 g each) 2 weeks apart at the beginning and then again at 6 months. Primary outcome was defined as preservation of kidney function at 12 months with stable or increased creatinine clearance. Secondary outcome was defined as achieving complete remission (CR) defined as proteinuria <300 mg/24 h or partial remission (PR) with proteinuria <3 g/24 h and at least 50% reduction in the proteinuria. DNAJB9 levels were also measured in the serum at baseline, 6 and 12 months. RESULTS The creatinine clearance did not change significantly during this time, from 47.7 mL/min/1.73 m2 at baseline to 43.7 mL/min/1.73 m2 during follow-up (P = 0.15). Proteinuria declined from 4.43 (1.6-5.53) g/24 h at baseline to 1.9 (0.46-5.26) g/24 h at 12 months but did not reach significance (P = 0.06). None of the patients reached CR, and 3 of the 11 achieved PR. There was no change in the DNAJB9 levels following treatment with rituximab. The most common adverse event was nasal congestion, fatigue and muscle cramps. CONCLUSIONS Treatment of patients with two courses of rituximab over a span of 6 months was associated with stabilization of renal function but did not result in a significant change in proteinuria and with no change in the DNAJB9 levels.",2020,Proteinuria declined from 4.43 (1.6-5.53) g/24 h at baseline to 1.9 (0.46-5.26) g/24 h at 12 months but did not reach significance (P = 0.06).,"['patients with idiopathic FGN', 'patients with FGN']",['rituximab'],"['preservation of kidney function at 12\u2009months with stable or increased creatinine clearance', 'Proteinuria', 'efficacy and safety', 'stabilization of renal function', 'achieving complete remission (CR) defined as proteinuria <300\u2009mg/24\u2009h or partial remission (PR', 'DNAJB9 levels', 'creatinine clearance', 'nasal congestion, fatigue and muscle cramps']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332240', 'cui_str': 'Unknown (origin)'}, {'cui': 'C0268749', 'cui_str': 'Fibrillary glomerulonephritis'}]","[{'cui': 'C0393022', 'cui_str': 'rituximab'}]","[{'cui': 'C0033085', 'cui_str': 'Preservation, Biologic'}, {'cui': 'C0232804', 'cui_str': 'Renal function'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C4760977', 'cui_str': 'Increased creatinine clearance'}, {'cui': 'C0033687', 'cui_str': 'Proteinuria'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1293130', 'cui_str': 'Stabilization'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C1521726', 'cui_str': 'In partial remission'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0373595', 'cui_str': 'Measurement of renal clearance of creatinine'}, {'cui': 'C0027424', 'cui_str': 'Nasal congestion'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0026821', 'cui_str': 'Cramp'}]",,0.126213,Proteinuria declined from 4.43 (1.6-5.53) g/24 h at baseline to 1.9 (0.46-5.26) g/24 h at 12 months but did not reach significance (P = 0.06).,"[{'ForeName': 'Stephen B', 'Initials': 'SB', 'LastName': 'Erickson', 'Affiliation': 'Division of Nephrology and Hypertension, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Ladan', 'Initials': 'L', 'LastName': 'Zand', 'Affiliation': 'Division of Nephrology and Hypertension, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Samih H', 'Initials': 'SH', 'LastName': 'Nasr', 'Affiliation': 'Department of Laboratory Medicine and Pathology, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Mariam P', 'Initials': 'MP', 'LastName': 'Alexander', 'Affiliation': 'Department of Laboratory Medicine and Pathology, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Nelson', 'Initials': 'N', 'LastName': 'Leung', 'Affiliation': 'Division of Nephrology and Hypertension, Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Maria Eleni', 'Initials': 'ME', 'LastName': 'Drosou', 'Affiliation': 'Department of Internal Medicine, Lankenau Medical Center, Philadelphia, PA, USA.'}, {'ForeName': 'Fernando C', 'Initials': 'FC', 'LastName': 'Fervenza', 'Affiliation': 'Division of Nephrology and Hypertension, Mayo Clinic, Rochester, MN, USA.'}]","Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association",['10.1093/ndt/gfaa065'] 2780,32617609,Anterolateral ligament reconstruction improves the clinical and functional outcomes of anterior cruciate ligament reconstruction in athletes.,"PURPOSE To compare the outcomes of anterior cruciate ligament (ACL) reconstruction with those of combined ACL and anterolateral ligament (ALL) reconstruction in ACL-deficient knees. The objective of this study was to improve knowledge regarding the treatment of ACL-deficient knees with combined ACL and ALL reconstruction. Combined ACL and ALL reconstruction has been hypothesized to result in better clinical and functional outcomes than isolated ACL reconstruction (ACLR). METHODS One-hundred and seven adult male athletes with ACL tears and high-grade pivot shifts were randomized into two groups. Those in group A (n = 54) underwent ACLR, while those in group B (n = 53) underwent combined ACL and ALL reconstruction. The median age was 26 (18-40) and 24 (18-33) years in groups A and B, respectively, and the median follow-up was 60 (55-65) months. Physical examination findings, instrumented knee laxity tested using a KT-1000 arthrometer, and International Knee Documentation Committee Scale (IKDC) scores were used to evaluate the outcomes. RESULTS One-hundred and two patients were available for follow-up: 52 in group A and 50 in group B. Postoperatively, the pivot shift was normal in 43 (82.7%) and 48 (96%) patients in groups A and B, respectively (p < 0.001). The median instrumented knee laxity was 2.5 ± 0.7 (1.2-6.1) mm in patients in group A and 1.2 ± 0.7 (1.2-3.2) mm in patients in group B (p < 0.001). Additionally, 44 (84.6%) patients in group A had normal IKDC scores and 3 (5.8%) had nearly normal scores, while 48 (96.0%) patients in group B had normal IKDC scores and 2 (4%) had nearly normal scores (p < 0.001). CONCLUSION Combined ACL and ALL reconstruction, compared with isolated ACLR resulted in favourable clinical and functional outcomes, as demonstrated by decreased rotational instability and instrumented knee laxity, a lower graft rupture rate and better postoperative IKDC scores. LEVEL OF EVIDENCE 1.",2020,"RESULTS One-hundred and two patients were available for follow-up: 52 in group A and 50 in group B. Postoperatively, the pivot shift was normal in 43 (82.7%) and 48 (96%) patients in groups A and B, respectively (p < 0.001).","['One-hundred and seven adult male athletes with ACL tears and high-grade pivot shifts', 'ACL-deficient knees', 'anterior cruciate ligament reconstruction in athletes']","['ACL-deficient knees with combined ACL and ALL reconstruction', 'Anterolateral ligament reconstruction', 'combined ACL and ALL reconstruction', 'anterior cruciate ligament (ACL) reconstruction with those of combined ACL and anterolateral ligament (ALL) reconstruction', 'Combined ACL and ALL reconstruction', 'ACLR']","['favourable clinical and functional outcomes', 'Physical examination findings, instrumented knee laxity tested using a KT-1000 arthrometer, and International Knee Documentation Committee Scale (IKDC) scores', 'rotational instability and instrumented knee laxity, a lower graft rupture rate and better postoperative IKDC scores', 'pivot shift', 'normal IKDC scores', 'normal scores', 'median instrumented knee laxity']","[{'cui': 'C4517529', 'cui_str': '107'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0409312', 'cui_str': 'Rupture of anterior cruciate ligament'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0333051', 'cui_str': 'Shift'}, {'cui': 'C0078960', 'cui_str': 'Structure of anterior cruciate ligament of knee joint'}, {'cui': 'C0011155', 'cui_str': 'Deficiency'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C3178820', 'cui_str': 'Anterior Cruciate Ligament Reconstruction'}]","[{'cui': 'C0078960', 'cui_str': 'Structure of anterior cruciate ligament of knee joint'}, {'cui': 'C0011155', 'cui_str': 'Deficiency'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0332194', 'cui_str': 'Anterolateral'}, {'cui': 'C0547071', 'cui_str': 'Ligament reconstruction'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}, {'cui': 'C0023685', 'cui_str': 'Structure of ligament'}, {'cui': 'C0162596', 'cui_str': 'Cardiolipin antibody'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0348000', 'cui_str': 'Instrument'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0332536', 'cui_str': 'Laxity'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0183894', 'cui_str': 'Arthrometer'}, {'cui': 'C0175636', 'cui_str': 'Documentation procedure'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0445237', 'cui_str': 'Rotational'}, {'cui': 'C0085633', 'cui_str': 'Mood swings'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0443294', 'cui_str': 'Ruptured'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0333051', 'cui_str': 'Shift'}, {'cui': 'C0205307', 'cui_str': 'Normal'}, {'cui': 'C0549183', 'cui_str': 'Midline'}]",107.0,0.0302006,"RESULTS One-hundred and two patients were available for follow-up: 52 in group A and 50 in group B. Postoperatively, the pivot shift was normal in 43 (82.7%) and 48 (96%) patients in groups A and B, respectively (p < 0.001).","[{'ForeName': 'Fawzy', 'Initials': 'F', 'LastName': 'Hamido', 'Affiliation': 'Division of Sports Medicine, Al-Razi Orthopaedic Hospital, Ministry of Health, Kuwait, Kuwait. fhf19633@yahoo.com.'}, {'ForeName': 'Abdelrahman A', 'Initials': 'AA', 'LastName': 'Habiba', 'Affiliation': 'Division of Sports Medicine, Al-Razi Orthopaedic Hospital, Ministry of Health, Kuwait, Kuwait.'}, {'ForeName': 'Yousef', 'Initials': 'Y', 'LastName': 'Marwan', 'Affiliation': 'Division of Sports Medicine, Al-Razi Orthopaedic Hospital, Ministry of Health, Kuwait, Kuwait.'}, {'ForeName': 'Aymen S I', 'Initials': 'ASI', 'LastName': 'Soliman', 'Affiliation': 'Department of Orthopaedic Surgery, Faculty of Medicine, Alexandria University, Alexandria, Egypt.'}, {'ForeName': 'Tarek A', 'Initials': 'TA', 'LastName': 'Elkhadrawe', 'Affiliation': 'Department of Orthopaedic Surgery, Faculty of Medicine, Alexandria University, Alexandria, Egypt.'}, {'ForeName': 'Mohamed G', 'Initials': 'MG', 'LastName': 'Morsi', 'Affiliation': 'Department of Orthopaedic Surgery, Faculty of Medicine, Alexandria University, Alexandria, Egypt.'}, {'ForeName': 'Wael', 'Initials': 'W', 'LastName': 'Shoaeb', 'Affiliation': 'Division of Sports Medicine, Al-Razi Orthopaedic Hospital, Ministry of Health, Kuwait, Kuwait.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Nagi', 'Affiliation': 'Division of Sports Medicine, Al-Razi Orthopaedic Hospital, Ministry of Health, Kuwait, Kuwait.'}]","Knee surgery, sports traumatology, arthroscopy : official journal of the ESSKA",['10.1007/s00167-020-06119-w'] 2781,32617646,The catechol-O-methyltransferase inhibitor tolcapone modulates alcohol consumption and impulsive choice in alcohol use disorder.,"RATIONALE Individuals suffering from alcohol use disorder (AUD) demonstrate difficulty with decision-making and impulsivity that may be associated with impaired frontal cortical function. Therapeutics that enhance frontal dopamine tone could decrease impulsivity and in turn reduce alcohol consumption in individuals with AUD. OBJECTIVES To determine if the catechol-O-methyltransferase (COMT) inhibitor tolcapone can attenuate alcohol consumption in individuals with AUD and whether this attenuation correlates with tolcapone-induced changes in laboratory-based decision-making tasks. METHODS We used daily self-report and a novel group laboratory bar task to assess the effects of randomized double-blind crossover administration of tolcapone (100 mg TID for 5 days) on alcohol consumption and laboratory tasks assessing impulsivity in 55 non-treatment-seeking subjects with AUD. RESULTS Tolcapone significantly reduced self-reported alcohol consumption (t (54) = 2.05, p = 0.045). The effects of tolcapone on drinking significantly correlated with changes in impulsive decision-making, such that subjects with the greatest decrease in impulsive choice on tolcapone also reported the greatest decrease in alcohol consumption (r (45) = 0.40, p = 0.0053). We did not see effects of tolcapone on laboratory bar consumption. Adverse event (AE) reporting was low, with no significant difference in frequency or severity of AEs on tolcapone versus placebo. CONCLUSIONS These data demonstrate that COMT inhibitors such as tolcapone may be useful therapeutics for AUD. TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT02740582.",2020,"Adverse event (AE) reporting was low, with no significant difference in frequency or severity of AEs on tolcapone versus placebo. ","['individuals with AUD', '55 non-treatment-seeking subjects with AUD', 'Individuals suffering from alcohol use disorder (AUD']","['catechol-O-methyltransferase (COMT) inhibitor tolcapone', 'tolcapone']","['alcohol consumption and laboratory tasks assessing impulsivity', 'frequency or severity of AEs', 'self-reported alcohol consumption', 'Adverse event (AE) reporting', 'alcohol consumption']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0001956', 'cui_str': 'Alcohol use disorder'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]","[{'cui': 'C0007407', 'cui_str': 'Catechol methyltransferase'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0246330', 'cui_str': 'tolcapone'}]","[{'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0021125', 'cui_str': 'Impulsive behaviour'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",,0.221006,"Adverse event (AE) reporting was low, with no significant difference in frequency or severity of AEs on tolcapone versus placebo. ","[{'ForeName': 'Allison R', 'Initials': 'AR', 'LastName': 'Coker', 'Affiliation': 'Department of Neurology, University of California, San Francisco, CA, USA. allison.coker@ucsf.edu.'}, {'ForeName': 'Dawn N', 'Initials': 'DN', 'LastName': 'Weinstein', 'Affiliation': 'Department of Neurology, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Taylor A', 'Initials': 'TA', 'LastName': 'Vega', 'Affiliation': 'Department of Neurology, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Catriona S', 'Initials': 'CS', 'LastName': 'Miller', 'Affiliation': 'Department of Neurology, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Andrew S', 'Initials': 'AS', 'LastName': 'Kayser', 'Affiliation': 'Department of Neurology, University of California, San Francisco, CA, USA.'}, {'ForeName': 'Jennifer M', 'Initials': 'JM', 'LastName': 'Mitchell', 'Affiliation': 'Department of Neurology, University of California, San Francisco, CA, USA.'}]",Psychopharmacology,['10.1007/s00213-020-05599-5'] 2782,32617651,Subchondral bone or intra-articular injection of bone marrow concentrate mesenchymal stem cells in bilateral knee osteoarthritis: what better postpone knee arthroplasty at fifteen years? A randomized study.,"PURPOSE There is an increasing number of reports on the treatment of knee osteoarthritis (OA) using mesenchymal stem cells (MSCs). However, it is not known what would better drive osteoarthritis stabilization to postpone total knee arthroplasty (TKA): targeting the synovial fluid by injection or targeting on the subchondral bone with MSCs implantation. METHODS A prospective randomized controlled clinical trial was carried out between 2000 and 2005 in 120 knees of 60 patients with painful bilateral knee osteoarthritis with a similar osteoarthritis grade. During the same anaesthesia, a bone marrow concentrate of 40 mL containing an average 5727 MSCs/mL (range 2740 to 7540) was divided in two equal parts: after randomization, one part (20 mL) was delivered to the subchondral bone of femur and tibia of one knee (subchondral group) and the other part was injected in the joint for the contralateral knee (intra-articular group). MSCs were counted as CFU-F (colony fibroblastic unit forming). Clinical outcomes of the patient (Knee Society score) were obtained along with radiological imaging outcomes (including MRIs) at two year follow-up. Subsequent revision surgeries were identified until the most recent follow-up (average of 15 years, range 13 to 18 years). RESULTS At two year follow-up, clinical and imaging (MRI) improvement was higher on the side that received cells in the subchondral bone. At the most recent follow-up (15 years), among the 60 knees treated with subchondral cell therapy, the yearly arthroplasty incidence was 1.3% per knee-year; for the 60 knees with intra-articular cell therapy, the yearly arthroplasty incidence was higher (p = 0.01) with an incidence of 4.6% per knee-year. For the side with subchondral cell therapy, 12 (20%) of 60 knees underwent TKA, while 42 (70%) of 60 knees underwent TKA on the side with intra-articular cell therapy. Among the 18 patients who had no subsequent surgery on both sides, all preferred the knee with subchondral cell therapy. CONCLUSIONS Implantation of MSCs in the subchondral bone of an osteoarthritic knee is more effective to postpone TKA than injection of the same intra-articular dose in the contralateral knee with the same grade of osteoarthritis.",2020,"At two year follow-up, clinical and imaging (MRI) improvement was higher on the side that received cells in the subchondral bone.","['18 patients who had no subsequent surgery on both sides, all preferred the knee with subchondral cell therapy', '2000 and 2005 in 120 knees of 60 patients with painful bilateral knee osteoarthritis with a similar osteoarthritis grade', 'bilateral knee osteoarthritis']","['Subchondral bone or intra-articular injection of bone marrow concentrate mesenchymal stem cells', 'subchondral cell therapy', 'TKA']","['yearly arthroplasty incidence', 'clinical and imaging (MRI) improvement']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0558295', 'cui_str': 'Preferences'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0302189', 'cui_str': 'Therapy, Cell'}, {'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0441800', 'cui_str': 'Grade'}]","[{'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0021488', 'cui_str': 'Intra-articular injection'}, {'cui': 'C0005953', 'cui_str': 'Bone marrow structure'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1257975', 'cui_str': 'Mesenchymal stem cell'}, {'cui': 'C0302189', 'cui_str': 'Therapy, Cell'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}]","[{'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0003893', 'cui_str': 'Arthroplasty'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0011923', 'cui_str': 'Imaging'}]",60.0,0.0249521,"At two year follow-up, clinical and imaging (MRI) improvement was higher on the side that received cells in the subchondral bone.","[{'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Hernigou', 'Affiliation': 'Orthopedic Department Henri Mondor Hospital, University Paris East, Creteil, France. philippe.hernigou@wanadoo.fr.'}, {'ForeName': 'Charlie', 'Initials': 'C', 'LastName': 'Bouthors', 'Affiliation': 'Orthopedic Department Kremlin Bicêtre Hospital, University Paris Sud, Kremlin Bicetre, France.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Bastard', 'Affiliation': 'Orthopedic Department Henri Mondor Hospital, University Paris East, Creteil, France.'}, {'ForeName': 'Charles Henri', 'Initials': 'CH', 'LastName': 'Flouzat Lachaniette', 'Affiliation': 'Orthopedic Department Henri Mondor Hospital, University Paris East, Creteil, France.'}, {'ForeName': 'Helene', 'Initials': 'H', 'LastName': 'Rouard', 'Affiliation': 'Cellular Therapy, Henri Mondor Hospital, University Paris East, Creteil, France.'}, {'ForeName': 'Arnaud', 'Initials': 'A', 'LastName': 'Dubory', 'Affiliation': 'Orthopedic Department Henri Mondor Hospital, University Paris East, Creteil, France.'}]",International orthopaedics,['10.1007/s00264-020-04687-7'] 2783,32617960,"Modeling the effect of DAV132, a novel colon-targeted adsorbent, on fecal concentrations of moxifloxacin and gut microbiota diversity in healthy volunteers.","To prevent antibiotic-induced perturbations on gut microbiota, DAV132, a novel colon-targeted adsorbent, which sequesters antibiotic residues in the lower gastrointestinal tract was developed. We built an integrated pharmacological model of how DAV132 reduces fecal free moxifloxacin (MXF) and preserves gut microbiota. We used plasma and fecal free MXF concentrations, and Shannon diversity index from 16S rRNA gene metagenomics analysis of fecal microbiota, of 143 healthy volunteers assigned randomly to receive MXF only, or with ten DAV132 dose regimens, or to a control group. We modeled reduced fecal MXF concentrations using a transit model for DAV132 kinetics and a Michaelis-Menten model with an effect of the amount of activated charcoal on adsorption efficacy. Changes in MXF-induced perturbations on gut microbiota diversity were then quantified through a turn-over model with the Emax model. With the developed model, the efficiency of pharmacokinetic antagonism and its consequences on gut microbiota diversity were quantified.",2020,We built an integrated pharmacological model of how DAV132 reduces fecal free moxifloxacin (MXF) and preserves gut microbiota.,"['healthy volunteers', '143 healthy volunteers assigned randomly to receive']","['DAV132', 'moxifloxacin (MXF', 'moxifloxacin', 'MXF']","['fecal MXF concentrations', 'gut microbiota diversity']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C4517573', 'cui_str': '143'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}]","[{'cui': 'C0536495', 'cui_str': 'moxifloxacin'}]","[{'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0536495', 'cui_str': 'moxifloxacin'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}]",143.0,0.0162659,We built an integrated pharmacological model of how DAV132 reduces fecal free moxifloxacin (MXF) and preserves gut microbiota.,"[{'ForeName': 'Jinju', 'Initials': 'J', 'LastName': 'Guk', 'Affiliation': 'Universite de Paris, IAME, INSERM, F-75018, Paris, France.'}, {'ForeName': 'Jérémie', 'Initials': 'J', 'LastName': 'Guedj', 'Affiliation': 'Universite de Paris, IAME, INSERM, F-75018, Paris, France.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Burdet', 'Affiliation': 'Universite de Paris, IAME, INSERM, F-75018, Paris, France.'}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Andremont', 'Affiliation': 'Universite de Paris, IAME, INSERM, F-75018, Paris, France.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'de Gunzburg', 'Affiliation': 'Da Volterra, Paris, France.'}, {'ForeName': 'Annie', 'Initials': 'A', 'LastName': 'Ducher', 'Affiliation': 'Da Volterra, Paris, France.'}, {'ForeName': 'France', 'Initials': 'F', 'LastName': 'Mentré', 'Affiliation': 'Universite de Paris, IAME, INSERM, F-75018, Paris, France.'}]",Clinical pharmacology and therapeutics,['10.1002/cpt.1977'] 2784,32618032,The role of novelty and fat and sugar concentration in food selection by captive tufted capuchins (Sapajus apella).,"Capuchins, like other primates, use feedback from sensory cues and digestion to make decisions about which foods to consume and which to avoid. However, little is known about how capuchins make consumption decisions when simultaneously presented with novel and familiar foods, or how food familiarity and macronutrient concentration together influence food choice, topics with potential implications for developmental and health research. In this study, we evaluated the role of familiarity, as well as fat and sugar concentration, in the food selections of captive tufted capuchins (Sapajus apella). In the first experiment, over 10 sessions, subjects were assigned to either a group that chose between one familiar and one novel food item both high in fat or sugar (high condition), or to a group that chose between one familiar and one novel food item both low in fat or sugar (low condition). In the second experiment, subjects were divided into three groups, familiarized with food over five feeding sessions, and then offered the familiarized food and a novel food that varied in fat or sugar for 10 sessions. When offered foods high in fat, capuchins showed no clear signs of neophobia, forming an initial preference for the novel food, rejecting foods less frequently, and selecting foods faster than when offered foods low in fat. These trends were generally not observed in response to foods with sugar. When presented with options that varied in macronutrient concentration, subjects showed an initial interest in the novel food irrespective of whether it was high in fat or sugar, yet formed a final preference for the higher-concentration item. Findings suggest that the concentration of fat or sugar in novel foods may be an important mediator of exploratory behavior and that capuchins rely on immediate feedback from taste and other sensory cues to make consumption decisions.",2020,"When offered foods high in fat, capuchins showed no clear signs of neophobia, forming an initial preference for the novel food, rejecting foods less frequently, and selecting foods faster than when offered foods low in fat.",[],"['familiarized with food over five feeding sessions, and then offered the familiarized food and a novel food that varied in fat or sugar for 10 sessions', 'one familiar and one novel food item both high in fat or sugar (high condition), or to a group that chose between one familiar and one novel food item both low in fat or sugar (low condition']",[],[],"[{'cui': 'C0016452', 'cui_str': 'Foods'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0205309', 'cui_str': 'Known'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0205251', 'cui_str': 'Low'}]",[],,0.0156631,"When offered foods high in fat, capuchins showed no clear signs of neophobia, forming an initial preference for the novel food, rejecting foods less frequently, and selecting foods faster than when offered foods low in fat.","[{'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Heuberger', 'Affiliation': 'Center on Social Dynamics and Policy, The Brookings Institution, Washington, District of Columbia.'}, {'ForeName': 'Annika', 'Initials': 'A', 'LastName': 'Paukner', 'Affiliation': 'School of Social Sciences, Nottingham Trent University, Nottingham, Nottingham, UK.'}, {'ForeName': 'Lauren J', 'Initials': 'LJ', 'LastName': 'Wooddell', 'Affiliation': 'Laboratory of Comparative Ethology, National Institute of Child Health and Human Development, Poolesville, Maryland.'}, {'ForeName': 'Matt', 'Initials': 'M', 'LastName': 'Kasman', 'Affiliation': 'Center on Social Dynamics and Policy, The Brookings Institution, Washington, District of Columbia.'}, {'ForeName': 'Ross A', 'Initials': 'RA', 'LastName': 'Hammond', 'Affiliation': 'Center on Social Dynamics and Policy, The Brookings Institution, Washington, District of Columbia.'}]",American journal of primatology,['10.1002/ajp.23165'] 2785,32618034,Effect of a health-education program using motivational interviewing on oral health behavior and self-efficacy in pregnant women: a randomized controlled trial.,"Oral health problems are common among pregnant women. The objective of this study was to examine the effectiveness of motivational interviewing (MI) as a behavior-change technique to enhance self-efficacy and oral health among pregnant women. A randomized controlled trial was conducted with 112 pregnant Iranian women. Women in the intervention group received an education program on oral health using MI during two face-to-face sessions, along with routine health education (two 1-h lectures on oral health changes and needs during pregnancy presented as a lecture by an oral health technician over a 2-wk period). Those in the control group received two 1-h lectures on oral health changes and needs during pregnancy. Oral health behaviors, oral health self-efficacy, and general self-efficacy, were assessed, along with gingival and dental health from baseline to the 3-month follow-up. Analysis of covariance was used to determine differences between intervention and control groups. Scores for both general and specific self-efficacy and for healthy behaviors increased in the intervention group, whereas there was no significant change within controls from baseline to follow-up. Between-group analyses also indicated a significant difference in the scores for self-efficacy and behavior favoring the intervention group. Scores on the gingival inflammation index decreased, as did the number of decayed teeth in the intervention group relative to the control group. The number of filled teeth increased significantly in the intervention group. Health education interventions using MI techniques may help to improve oral health-related self-efficacy and behaviors among pregnant women.",2020,"Scores for both general and specific self-efficacy and for healthy behaviors increased in the intervention group, whereas there was no significant change within controls from baseline to follow-up.","['112 pregnant Iranian women', 'pregnant women']","['education program on oral health using MI during two face-to-face sessions, along with routine health education (two 1-h lectures on oral health changes and needs during pregnancy presented as a lecture by an oral health technician', 'motivational interviewing (MI', 'health-education program using motivational interviewing']","['oral health behavior and self-efficacy', 'oral health-related self-efficacy and behaviors', 'gingival inflammation index', 'Oral health behaviors, oral health self-efficacy, and general self-efficacy', 'number of decayed teeth', 'number of filled teeth', 'healthy behaviors', 'scores for self-efficacy and behavior']","[{'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}]","[{'cui': 'C0729314', 'cui_str': 'Education provision'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0700308', 'cui_str': 'Protium'}, {'cui': 'C0376683', 'cui_str': 'Lectures'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0150312', 'cui_str': 'Present'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0017574', 'cui_str': 'Gingivitis'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0399066', 'cui_str': 'Insertion of malleable restoration into tooth'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",112.0,0.0459472,"Scores for both general and specific self-efficacy and for healthy behaviors increased in the intervention group, whereas there was no significant change within controls from baseline to follow-up.","[{'ForeName': 'Mohsen', 'Initials': 'M', 'LastName': 'Saffari', 'Affiliation': 'Health Research Center, Life Style Institute, Baqiyatallah University of Medical Sciences Tehran, Iran.'}, {'ForeName': 'Hormoz', 'Initials': 'H', 'LastName': 'Sanaeinasab', 'Affiliation': 'Health Research Center, Life Style Institute, Baqiyatallah University of Medical Sciences Tehran, Iran.'}, {'ForeName': 'Masoume', 'Initials': 'M', 'LastName': 'Mobini', 'Affiliation': 'Health Education Department, Faculty of Health, Baqiyatallah University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mojtaba', 'Initials': 'M', 'LastName': 'Sepandi', 'Affiliation': 'Health Research Center, Life Style Institute, Baqiyatallah University of Medical Sciences Tehran, Iran.'}, {'ForeName': 'Hojat', 'Initials': 'H', 'LastName': 'Rashidi-Jahan', 'Affiliation': 'Health Research Center, Life Style Institute, Baqiyatallah University of Medical Sciences Tehran, Iran.'}, {'ForeName': 'Mohammad G', 'Initials': 'MG', 'LastName': 'Sehlo', 'Affiliation': 'Department of Psychiatry, King Abdulaziz University, Jeddah, Saudi Arabia.'}, {'ForeName': 'Harold G', 'Initials': 'HG', 'LastName': 'Koenig', 'Affiliation': 'Department of Psychiatry, King Abdulaziz University, Jeddah, Saudi Arabia.'}]",European journal of oral sciences,['10.1111/eos.12704'] 2786,32618037,"Effect of an aqueous extract of Terminalia chebula on endothelial dysfunction, systemic inflammation, and lipid profile in type 2 diabetes mellitus: A randomized double-blind, placebo-controlled clinical study.","Endothelial dysfunction is a crucial complication in type 2 diabetic patients, related to cardiovascular risk. Terminalia chebula (TC), a traditional ayurvedic herb, is known for its antioxidant and antihyperlipidemic activity. A prospective, randomized, double-blind, placebo-controlled clinical study was undertaken to evaluate the effects of an aqueous extract of T. chebula 250 and 500 mg versus placebo on endothelial dysfunction and biomarkers of oxidative stress in type 2 diabetic patients. A total of 60 eligible patients were randomized to receive either T. chebula 250 mg, T. chebula 500 mg, or placebo twice daily for 12 weeks. The subjects were assessed based on the endothelial function, the levels of nitric oxide, malondialdehyde, glutathione, high sensitivity C-reactive protein, glycosylated hemoglobin, and lipid profile at baseline and after 12 weeks of treatment. Treatment with T. chebula 250 mg and T. chebula 500 mg for 12 weeks significantly improved the endothelial function (reflection index) compared to placebo (absolute changes: - T. chebula 250: -2.55 ± 1.82% vs. T. chebula 500: -5.21 ± 2.41% vs. placebo: 1.40 ± 2.11%). Other cardiovascular risk indicators were also significantly ameliorated in the treatment groups compared to placebo. In conclusion, T. chebula (especially, 500 mg BID dose) significantly minimized the cardiovascular risk factors in patients with type 2 diabetes compared to placebo.",2020,Other cardiovascular risk indicators were also significantly ameliorated in the treatment groups compared to placebo.,"['60 eligible patients', 'type 2 diabetes mellitus', 'patients with type 2 diabetes', 'type 2 diabetic patients']","['T. chebula 250\u2009mg, T. chebula 500\u2009mg, or placebo', 'aqueous extract of Terminalia chebula', 'Terminalia chebula (TC', 'aqueous extract of T. chebula 250 and 500\u2009mg versus placebo', 'placebo']","['endothelial function, the levels of nitric oxide, malondialdehyde, glutathione, high sensitivity C-reactive protein, glycosylated hemoglobin, and lipid profile', 'Endothelial dysfunction', 'cardiovascular risk factors', 'endothelial dysfunction and biomarkers of oxidative stress', 'cardiovascular risk indicators', 'endothelial function (reflection index', 'endothelial dysfunction, systemic inflammation, and lipid profile']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0011860', 'cui_str': 'Type 2 diabetes mellitus'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}]","[{'cui': 'C2348831', 'cui_str': '250'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0185115', 'cui_str': 'Extraction'}, {'cui': 'C0330871', 'cui_str': 'Terminalia'}]","[{'cui': 'C0014257', 'cui_str': 'Structure of endothelium tissue'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0017817', 'cui_str': 'Glutathione'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0856169', 'cui_str': 'Endothelial dysfunction'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}]",60.0,0.274419,Other cardiovascular risk indicators were also significantly ameliorated in the treatment groups compared to placebo.,"[{'ForeName': 'Usharani', 'Initials': 'U', 'LastName': 'Pingali', 'Affiliation': ""Department of Clinical Pharmacology & Therapeutics, Nizam's Institute of Medical Sciences, Hyderabad, India.""}, {'ForeName': 'Deepasree', 'Initials': 'D', 'LastName': 'Sukumaran', 'Affiliation': ""Department of Clinical Pharmacology & Therapeutics, Nizam's Institute of Medical Sciences, Hyderabad, India.""}, {'ForeName': 'Chandrasekhar', 'Initials': 'C', 'LastName': 'Nutalapati', 'Affiliation': ""Department of Clinical Pharmacology & Therapeutics, Nizam's Institute of Medical Sciences, Hyderabad, India.""}]",Phytotherapy research : PTR,['10.1002/ptr.6771'] 2787,32618048,"Effectiveness, safety and tolerability of Bilastine 20 mg vs Levocetirizine 5 mg for the treatment of chronic spontaneous urticaria: a double-blind, parallel group, randomized controlled trial.",,2020,,['chronic spontaneous urticaria'],['Bilastine 20\u2009mg vs Levocetirizine'],"['Effectiveness, safety and tolerability']","[{'cui': 'C0578870', 'cui_str': 'Chronic idiopathic urticaria'}]","[{'cui': 'C1101148', 'cui_str': 'bilastine'}, {'cui': 'C1174893', 'cui_str': 'levocetirizine'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.259027,,"[{'ForeName': 'Indrashis', 'Initials': 'I', 'LastName': 'Podder', 'Affiliation': 'Department of Dermatology, College of Medicine and Sagore Dutta Hospital, Kamarhati, West Bengal, India.'}, {'ForeName': 'Anupam', 'Initials': 'A', 'LastName': 'Das', 'Affiliation': 'Department of Dermatology, KPC Medical College and Hospital, Kolkata, West Bengal, India.'}, {'ForeName': 'Shouvik', 'Initials': 'S', 'LastName': 'Ghosh', 'Affiliation': 'Department of Dermatology, KPC Medical College and Hospital, Kolkata, West Bengal, India.'}, {'ForeName': 'Debalina', 'Initials': 'D', 'LastName': 'Biswas', 'Affiliation': 'Department of Dermatology, KPC Medical College and Hospital, Kolkata, West Bengal, India.'}, {'ForeName': 'Sujata', 'Initials': 'S', 'LastName': 'Sengupta', 'Affiliation': 'Department of Dermatology, KPC Medical College and Hospital, Kolkata, West Bengal, India.'}, {'ForeName': 'Satyendra Nath', 'Initials': 'SN', 'LastName': 'Chowdhury', 'Affiliation': 'Department of Dermatology, College of Medicine and Sagore Dutta Hospital, Kamarhati, West Bengal, India.'}]",Dermatologic therapy,['10.1111/dth.13946'] 2788,32618115,A mobile health-facilitated behavioural intervention for community health workers improves exclusive breastfeeding and early infant HIV diagnosis in India: a cluster randomized trial.,"INTRODUCTION India's national AIDS Control Organization implemented World Health Organization's option B+ HIV prevention of mother-to-child transmission (PMTCT) guidelines in 2013. However, scalable strategies to improve uptake of new PMTCT guidelines to reduce new infection rates are needed. This study assessed impact of Mobile Health-Facilitated Behavioral Intervention on the uptake of PMTCT services. METHODS A cluster-randomized trial of a mobile health (mHealth)-supported behavioural training intervention targeting outreach workers (ORWs) was conducted in four districts of Maharashtra, India. Clusters (one Integrated Counselling and Testing Center (ICTC, n = 119), all affiliated ORWs (n = 116) and their assigned HIV-positive pregnant/postpartum clients (n = 1191)) were randomized to standard-of-care (SOC) ORW training vs. the COMmunity home Based INDia (COMBIND) intervention - specialized behavioural training plus a tablet-based mHealth application to support ORW-patient communication and patient engagement in HIV care. Impact on uptake of maternal antiretroviral therapy at delivery, exclusive breastfeeding at six months, infant nevirapine prophylaxis, and early infant diagnosis at six months was assessed using multi-level random-effects logistic regression models. RESULTS Of 1191 HIV-positive pregnant/postpartum women, 884 were eligible for primary outcome assessment; 487 were randomized to COMBIND. Multivariable analyses identified no statistically significant differences in any primary outcome by study arm. COMBIND was associated with higher uptake of exclusive breastfeeding at two months (adjusted Odds Ratio (aOR), 2.10; 95% CI 1.06 to 4.15) and early infant diagnosis at six weeks (aOR, 2.19; 95% CI 1.05 to 3.98) than SOC. CONCLUSIONS The COMBIND intervention was easily integrated into India's existing PMTCT programme and improved early uptake of two PMTCT components that require self-motivated health-seeking behaviour, thus providing preliminary evidence to support COMBIND as a potentially scalable PMTCT strategy. Further study would identify modifications needed to optimize other PMTCT outcomes.",2020,"The COMBIND intervention was easily integrated into India's existing PMTCT programme and improved early uptake of two PMTCT components that require self-motivated health-seeking behaviour, thus providing preliminary evidence to support COMBIND as a potentially scalable PMTCT strategy.","['Clusters (one Integrated Counselling and Testing Center (ICTC, n\xa0=\xa0119), all affiliated ORWs (n\xa0=\xa0116) and their assigned HIV-positive pregnant/postpartum clients (n\xa0=\xa01191', 'targeting outreach workers (ORWs) was conducted in four districts of Maharashtra, India', 'community health workers improves exclusive breastfeeding and early infant HIV diagnosis in India', '1191 HIV-positive pregnant/postpartum women, 884 were eligible for primary outcome assessment; 487']","['mobile health-facilitated behavioural intervention', 'mobile health (mHealth)-supported behavioural training intervention', 'specialized behavioural training plus a tablet-based mHealth application to support ORW-patient communication and patient engagement in HIV care', 'standard-of-care (SOC) ORW training vs. the COMmunity home Based INDia', 'Mobile Health-Facilitated Behavioral Intervention']","['higher uptake of exclusive breastfeeding', 'early infant diagnosis']","[{'cui': 'C0009085', 'cui_str': 'Clustering'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C4517541', 'cui_str': '116'}, {'cui': 'C0019699', 'cui_str': 'HIV positive'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0086839', 'cui_str': 'Postpartum'}, {'cui': 'C0008942', 'cui_str': 'Clients'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0009467', 'cui_str': 'Community Health Aides'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0242205', 'cui_str': 'Breastfeeding, Exclusive'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0032804', 'cui_str': 'Postpartum Women'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0085565', 'cui_str': 'Outcome Assessment (Health Care)'}]","[{'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0185125', 'cui_str': 'Application'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C3508152', 'cui_str': 'Patient Engagement'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0242205', 'cui_str': 'Breastfeeding, Exclusive'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]",,0.232194,"The COMBIND intervention was easily integrated into India's existing PMTCT programme and improved early uptake of two PMTCT components that require self-motivated health-seeking behaviour, thus providing preliminary evidence to support COMBIND as a potentially scalable PMTCT strategy.","[{'ForeName': 'Nishi', 'Initials': 'N', 'LastName': 'Suryavanshi', 'Affiliation': 'Lakshya, Society for Public Health Education and Research, Pune, India.'}, {'ForeName': 'Abhay', 'Initials': 'A', 'LastName': 'Kadam', 'Affiliation': 'Lakshya, Society for Public Health Education and Research, Pune, India.'}, {'ForeName': 'Nikhil', 'Initials': 'N', 'LastName': 'Gupte', 'Affiliation': 'School of Medicine, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Asha', 'Initials': 'A', 'LastName': 'Hegde', 'Affiliation': 'National AIDS Control Organization, New Delhi, India.'}, {'ForeName': 'Savita', 'Initials': 'S', 'LastName': 'Kanade', 'Affiliation': 'Lakshya, Society for Public Health Education and Research, Pune, India.'}, {'ForeName': 'Srilatha', 'Initials': 'S', 'LastName': 'Sivalenka', 'Affiliation': 'Division of Global HIV & TB - India Country Office, US Centers for Disease Control and Prevention, New Delhi, India.'}, {'ForeName': 'V Sampath', 'Initials': 'VS', 'LastName': 'Kumar', 'Affiliation': 'Division of Global HIV & TB - India Country Office, US Centers for Disease Control and Prevention, New Delhi, India.'}, {'ForeName': 'Amita', 'Initials': 'A', 'LastName': 'Gupta', 'Affiliation': 'School of Medicine, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Robert C', 'Initials': 'RC', 'LastName': 'Bollinger', 'Affiliation': 'School of Medicine, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Anita', 'Initials': 'A', 'LastName': 'Shankar', 'Affiliation': 'Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'McKenzie-White', 'Affiliation': 'School of Medicine, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Vidya', 'Initials': 'V', 'LastName': 'Mave', 'Affiliation': 'School of Medicine, Johns Hopkins University, Baltimore, MD, USA.'}]",Journal of the International AIDS Society,['10.1002/jia2.25555'] 2789,32618122,Prospective randomized trial of interventions for vincristine-related neuropathic pain.,"BACKGROUND To evaluate the efficacy of gabapentin at 20 mg/kg per day in the treatment of vincristine-related neuropathic pain. PROCEDURE Children aged 1-18 years who developed vincristine-induced neuropathy on a St Jude frontline acute lymphoblastic leukemia trial were prospectively enrolled on a randomized, double-blind, placebo-controlled, phase II trial with two treatment arms: gabapentin plus opioid versus placebo plus opioid. Daily evaluations of morphine dose (mg/kg per day) and pain scores were conducted for up to 21 days; the values of the two arms were compared to assess analgesic efficacy. RESULTS Of 51 study participants, 49 were eligible for analyses. Twenty-five participants were treated with gabapentin, with a mean (SD) dose of 17.97 (2.76) mg/kg per day (median 18.26, range 6.82-21.37). The mean (SD) opioid doses taken, expressed as morphine equivalent daily (mg/kg per day), were 0.26 (0.43) in the gabapentin group (25 patients, 432 days) and 0.15 (0.22) in the placebo group (24 patients, 411 days; P = .15). Only the risk classification of acute lymphoblastic leukemia was significantly associated with the daily morphine dosage (P = .0178): patients in the lower risk arm received higher daily morphine dosages. Multivariate analyses revealed a significant difference between the groups' average daily scores for the previous 24 h and ""right now."" CONCLUSION In this population of children with vincristine-related neuropathic pain, opioid consumption and pain scores were higher in the gabapentin group than in the placebo group. Future randomized, double-blind, placebo-controlled studies should test gabapentin given longer or at a higher dose.",2020,Only the risk classification of acute lymphoblastic leukemia was significantly associated with the daily morphine dosage (P = .0178),['Children aged 1-18\xa0years who developed vincristine-induced neuropathy on a St Jude frontline acute lymphoblastic leukemia trial'],"['vincristine', 'gabapentin plus opioid versus placebo plus opioid', 'placebo', 'gabapentin', 'morphine']","['neuropathic pain, opioid consumption and pain scores', 'pain scores', 'analgesic efficacy', 'risk classification of acute lymphoblastic leukemia', 'neuropathic pain']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0042679', 'cui_str': 'Vincristine'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0442874', 'cui_str': 'Neuropathy'}, {'cui': 'C0023449', 'cui_str': 'Acute lymphoid leukemia'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0042679', 'cui_str': 'Vincristine'}, {'cui': 'C0060926', 'cui_str': 'gabapentin'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}]","[{'cui': 'C0027796', 'cui_str': 'Neuralgia'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0023449', 'cui_str': 'Acute lymphoid leukemia'}]",25.0,0.610989,Only the risk classification of acute lymphoblastic leukemia was significantly associated with the daily morphine dosage (P = .0178),"[{'ForeName': 'Doralina L', 'Initials': 'DL', 'LastName': 'Anghelescu', 'Affiliation': ""Division of Anesthesiology, Department of Pediatric Medicine, St Jude Children's Research Hospital, Memphis, Tennessee.""}, {'ForeName': 'Jessica Michala', 'Initials': 'JM', 'LastName': 'Tesney', 'Affiliation': ""Division of Anesthesiology, Department of Pediatric Medicine, St Jude Children's Research Hospital, Memphis, Tennessee.""}, {'ForeName': 'Sima', 'Initials': 'S', 'LastName': 'Jeha', 'Affiliation': ""Department of Oncology, St Jude Children's Research Hospital, Memphis, Tennessee.""}, {'ForeName': 'Becky B', 'Initials': 'BB', 'LastName': 'Wright', 'Affiliation': ""Division of Anesthesiology, Department of Pediatric Medicine, St Jude Children's Research Hospital, Memphis, Tennessee.""}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Trujillo', 'Affiliation': ""Division of Anesthesiology, Department of Pediatric Medicine, St Jude Children's Research Hospital, Memphis, Tennessee.""}, {'ForeName': 'John T', 'Initials': 'JT', 'LastName': 'Sandlund', 'Affiliation': ""Department of Oncology, St Jude Children's Research Hospital, Memphis, Tennessee.""}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Pauley', 'Affiliation': ""Department of Pharmaceutical Sciences, St Jude Children's Research Hospital, Memphis, Tennessee.""}, {'ForeName': 'Cheng', 'Initials': 'C', 'LastName': 'Cheng', 'Affiliation': ""Department of Biostatistics, St Jude Children's Research Hospital, Memphis, Tennessee.""}, {'ForeName': 'Deqing', 'Initials': 'D', 'LastName': 'Pei', 'Affiliation': ""Department of Biostatistics, St Jude Children's Research Hospital, Memphis, Tennessee.""}, {'ForeName': 'Ching-Hon', 'Initials': 'CH', 'LastName': 'Pui', 'Affiliation': ""Department of Oncology, St Jude Children's Research Hospital, Memphis, Tennessee.""}]",Pediatric blood & cancer,['10.1002/pbc.28539'] 2790,32618134,Effect of melatonin on heart failure: design for a double-blinded randomized clinical trial.,"AIMS Current studies indicate that melatonin can counteract renin-angiotensin-aldosterone system and sympathetic over activity in heart failure (HF) and might have a protective and repairing effect on cardiovascular injuries, skeletal muscle weakness, and metabolic abnormalities, which are common pathological processes in patients with HF. The MeHR trial (Melatonin for Heart Failure with Reduced Ejection Fraction) aims to evaluate the effect of oral melatonin on myocardial, skeletal muscle, and metabolic dysfunctions in HF, which leads to lower quality of life and increased morbidity and mortality in these patients. METHODS AND RESULTS This is a double-blind randomized clinical trial with two parallel arms of 1:1 allocation, which recruits 90 outpatients with HF with reduced ejection fraction. Participants receive 10 mg tablets of melatonin or placebo for 24 weeks. The primary outcomes are changes in echocardiographic indexes of HF and serum levels of N terminal pro brain natriuretic peptide. Secondary outcome is a composite clinical endpoint score including all-cause mortality, hospitalization for HF, and change in the quality of life during the study. Other outcomes are the evaluation of melatonin attributable adverse effects, flow-mediated vasodilation, skeletal muscle mass, exercise capacity, and serum markers of inflammation, oxidative stress, and metabolism. Statistical analysis will include simple unadjusted analyses for the detection of differences between groups and changes in outcomes and also a generalized linear mixed model to explore potential associations between outcomes and participant characteristics. CONCLUSIONS The results of this comprehensive study might elucidate the safety of oral melatonin in patients with HF and provide some evidence on its effectiveness as an adjunctive therapy to enhance the well-being of these patients.",2020,"Other outcomes are the evaluation of melatonin attributable adverse effects, flow-mediated vasodilation, skeletal muscle mass, exercise capacity, and serum markers of inflammation, oxidative stress, and metabolism.","['patients with HF', 'heart failure (HF', '90 outpatients with HF with reduced ejection fraction']","['melatonin or placebo', 'melatonin', 'oral melatonin']","['myocardial, skeletal muscle, and metabolic dysfunctions', 'composite clinical endpoint score including all-cause mortality, hospitalization for HF, and change in the quality of life', 'changes in echocardiographic indexes of HF and serum levels of N terminal pro brain natriuretic peptide', 'heart failure', 'adverse effects, flow-mediated vasodilation, skeletal muscle mass, exercise capacity, and serum markers of inflammation, oxidative stress, and metabolism']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C3839346', 'cui_str': 'Heart failure with reduced ejection fraction'}]","[{'cui': 'C0025219', 'cui_str': 'Melatonin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0242692', 'cui_str': 'Skeletal muscle structure'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0754710', 'cui_str': 'Pro-brain natriuretic peptide'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C0042401', 'cui_str': 'Vasodilatation'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0162491', 'cui_str': 'Marker, Serum'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}]",90.0,0.60701,"Other outcomes are the evaluation of melatonin attributable adverse effects, flow-mediated vasodilation, skeletal muscle mass, exercise capacity, and serum markers of inflammation, oxidative stress, and metabolism.","[{'ForeName': 'Masoumeh', 'Initials': 'M', 'LastName': 'Sadeghi', 'Affiliation': 'Cardiac Rehabilitation Research Center, Cardiovascular Research Institute, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Saeid', 'Initials': 'S', 'LastName': 'Khosrawi', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, School of Medicine, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Kiyan', 'Initials': 'K', 'LastName': 'Heshmat-Ghahdarijani', 'Affiliation': 'Heart Failure Research Center, Cardiovascular Research Institute, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Yousof', 'Initials': 'Y', 'LastName': 'Gheisari', 'Affiliation': 'Regenerative Medicine Research Center, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Hamidreza', 'Initials': 'H', 'LastName': 'Roohafza', 'Affiliation': 'Cardiac Rehabilitation Research Center, Cardiovascular Research Institute, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Marjan', 'Initials': 'M', 'LastName': 'Mansoorian', 'Affiliation': 'Isfahan Cardiovascular Research Center, Cardiovascular Research Institute, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Shervin Ghaffari', 'Initials': 'SG', 'LastName': 'Hoseini', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, School of Medicine, Isfahan University of Medical Sciences, Isfahan, Iran.'}]",ESC heart failure,['10.1002/ehf2.12829'] 2791,32618165,"The use of ozone therapy for treatment of periodontal disease: a split-mouth, randomized, controlled clinical trial.","Periodontal treatment has the aim to reduce oral infection and prevent the progression of the disease. The potential benefits of new therapy with Ozonline® for periodontal treatment, include improved patient compliance and an easier access to periodontal pocket. The objective of this study was to explore the efficacy of Ozonline® in the treatment of chronic periodontitis in adult patients. A randomized controlled split-mouth study was carried out in ten patients (5 men and 5 women age 42-73 mean 55 ±7) with a diagnosis of chronic periodontitis. None of these patients received any surgical or non-surgical periodontal therapy and demonstrated radiographic evidence of moderate bone loss. The mouth has been divided into upper right and left quadrants. The upper and lower right quadrants were treated with ultrasonic scaler, the left quadrants with ultrasonic scaler with ozonated water (Ozonline®). 10 microbiological samples were collected from upper left quadrants and 10 from upper right quadrants from each patient. Microbiological samples were collected from the sites of the patients at baseline and at the 7th day. 20 localized chronic periodontitis sites were selected (10 in left quadrants and 10 in right quadrants). After the treatment with Ozonline®, a remarkable decrease in bacteria amount, both for some species and for the total count was observed in the left quadrants respect to right ones. Specifically, T. forsythia and T. denticola were eradicated whereas Total Bacteria Loading and Fusobacterium nucleatum showed a reduction of 38% and 55%, respect to right quadrants. Our study demonstrated the efficacy of the Ozonline® in the management of moderate to severe chronic periodontitis. .",2020,"After the treatment with Ozonline®, a remarkable decrease in bacteria amount, both for some species and for the total count was observed in the left quadrants respect to right ones.","['chronic periodontitis in adult patients', 'ten patients (5 men and 5 women age 42-73 mean 55 ±7) with a diagnosis of chronic periodontitis']","['ultrasonic scaler, the left quadrants with ultrasonic scaler with ozonated water (Ozonline®', 'Ozonline®', 'ozone therapy']","['total count', 'bacteria amount']","[{'cui': 'C0266929', 'cui_str': 'Chronic periodontitis'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0183103', 'cui_str': 'Dental ultrasonic scaler'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C4727847', 'cui_str': 'Ozone therapy'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0439157', 'cui_str': 'counts'}, {'cui': 'C0004611', 'cui_str': 'Bacterium'}]",20.0,0.0173597,"After the treatment with Ozonline®, a remarkable decrease in bacteria amount, both for some species and for the total count was observed in the left quadrants respect to right ones.","[{'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Piva', 'Affiliation': 'Private Practice, Ferrara, Italy.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Avantaggiato', 'Affiliation': 'Private Practice, Ferrara, Italy.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Candotto', 'Affiliation': 'Department of Biomedical, Surgical and Dental Sciences University of Milan, 20122 Milan, Italy.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Pellati', 'Affiliation': 'Department of Morphology, Surgery and Experimental Medicina, University of Ferrara, Ferrara, Italy.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Moreo', 'Affiliation': 'Department of Medicine and Surgery, Centre of Neuroscience of Milan, University of Milan-Bicocca, 20900 Milan, Italy.'}]",Journal of biological regulators and homeostatic agents,[] 2792,32618212,Impact of a Music Intervention on Quality of Life in Breast Cancer Patients Undergoing Chemotherapy: A Randomized Clinical Trial.,"Background: Music can influence human behavior and may be used as a complementary therapy in health care. Objectives: To assess the effect of music interventions on symptoms, adverse events, and quality of life (QoL) of breast cancer patients undergoing chemotherapy (CT). Design: Nonblinded, randomized clinical trial. Women with breast cancer undergoing adjuvant CT were randomized into 2 groups-Group Music (GM) or Group Control (GC)-and followed during the first 3 cycles of treatment. Measurements: Sociodemographic data, WHOQOL-BREF, BDI-II, BAI, and Chemotherapy Toxicity Scale were assessed. Patients were evaluated after each session of the first 3 CT cycles. GM underwent a 30-minute musical intervention before CT. There was no intervention in the GC. Continuous data were analyzed by Student's t test, and χ 2 test was used to compare qualitative variables. Results: Higher QoL scores on functional scales were observed for the GM in comparison to the GC after the first and third sessions of CT. Depression ( P < .001) and anxiety scores ( P < .001) and vomiting ( P < .01) incidence were lower for the GM in the third session of CT. All the participants in the GM reported positive changes in life in the Subjective Impression of the Subject questionnaire, as well as improvement in fatigue and reduced stress levels. Conclusions: Improvements in QoL, anxiety, depression, and incidence of vomiting were associated with the music intervention, suggesting a positive effect of the music intervention on adverse events of cancer CT.",2020,Higher QoL scores on functional scales were observed for the GM in comparison to the GC after the first and third sessions of CT.,"['breast cancer patients undergoing chemotherapy (CT', 'Breast Cancer Patients', 'Women with breast cancer undergoing adjuvant CT']","['Undergoing Chemotherapy', 'Music Intervention', 'music intervention', 'Group Music (GM) or Group Control (GC)-and', 'music interventions']","['QoL, anxiety, depression, and incidence of vomiting', 'Depression', 'symptoms, adverse events, and quality of life (QoL', 'Quality of Life', 'fatigue and reduced stress levels', 'Sociodemographic data, WHOQOL-BREF, BDI-II, BAI, and Chemotherapy Toxicity Scale', 'adverse events of cancer CT', 'vomiting', 'anxiety scores', 'Higher QoL scores on functional scales']","[{'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C1319127', 'cui_str': 'Level of stress'}, {'cui': 'C0006448', 'cui_str': 'Burundi'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0205245', 'cui_str': 'Functional'}]",,0.0919337,Higher QoL scores on functional scales were observed for the GM in comparison to the GC after the first and third sessions of CT.,"[{'ForeName': 'Talita Uchoa', 'Initials': 'TU', 'LastName': 'Lima', 'Affiliation': 'Federal University of Maranhão, Sao Luis, Maranhão, Brazil.'}, {'ForeName': 'Ed Carlos Rey', 'Initials': 'ECR', 'LastName': 'Moura', 'Affiliation': 'Federal University of Maranhão, Sao Luis, Maranhão, Brazil.'}, {'ForeName': 'Caio Márcio Barros de', 'Initials': 'CMB', 'LastName': 'Oliveira', 'Affiliation': 'Federal University of Maranhão, Sao Luis, Maranhão, Brazil.'}, {'ForeName': 'Rachel Jorge Dino Cossetti', 'Initials': 'RJDC', 'LastName': 'Leal', 'Affiliation': 'UDI and Aldenora Bello Hospitals, Sao Luis, Maranhão, Brazil.'}, {'ForeName': 'João', 'Initials': 'J', 'LastName': 'Nogueira Neto', 'Affiliation': 'Federal University of Maranhão, Sao Luis, Maranhão, Brazil.'}, {'ForeName': 'Emanuel Cabral', 'Initials': 'EC', 'LastName': 'Pereira', 'Affiliation': 'Federal University of Maranhão, Sao Luis, Maranhão, Brazil.'}, {'ForeName': 'Raniere Victor Braga', 'Initials': 'RVB', 'LastName': 'Nascimento', 'Affiliation': 'Federal University of Maranhão, Sao Luis, Maranhão, Brazil.'}, {'ForeName': 'Eduardo José Silva Gomes de', 'Initials': 'EJSG', 'LastName': 'Oliveira', 'Affiliation': 'Federal University of Maranhão, Sao Luis, Maranhão, Brazil.'}, {'ForeName': 'Plínio da Cunha', 'Initials': 'PDC', 'LastName': 'Leal', 'Affiliation': 'Federal University of Maranhão, Sao Luis, Maranhão, Brazil.'}]",Integrative cancer therapies,['10.1177/1534735420938430'] 2793,32610342,Hepcidin is a relevant iron status indicator in infancy: results from a randomized trial of early vs. delayed cord clamping.,"BACKGROUND We aimed to evaluate whether serum hepcidin is a useful indicator of iron status in infants. METHODS Term infants (n = 400) were randomized to delayed (≥180 s) or early (≤10 s) cord clamping (CC). Iron status was assessed at 4 and 12 months. In all cases with iron depletion or iron deficiency (ID) (as defined in ""Methods"") (n = 30) and 97 randomly selected iron-replete infants, we analyzed hepcidin and explored its correlation to the intervention, iron status, and perinatal factors. RESULTS Serum hepcidin concentrations were significantly lower in the early CC group at both time points and in ID infants at 4 months. Median (2.5th-97.5th percentile) hepcidin in non-ID infants in the delayed CC group (suggested reference) was 64.5 (10.9-142.1), 39.5 (3.5-157.7), and 32.9 (11.2-124.2) ng/mL in the cord blood and at 4 and 12 months, respectively. The value of 16 ng/mL was a threshold detecting all cases of iron depletion/ID at 4 months. No similar threshold for ID was observed at 12 months. The strongest predictor of hepcidin at both ages was ferritin. CONCLUSIONS Hepcidin is relevant as iron status indicator in early infancy and may be useful to detect ID. Levels <16 ng/mL at 4 months of age indicates ID. IMPACT Serum hepcidin is a relevant indicator of iron status in early infancy.Normal reference in healthy infants is suggested in this study.Serum hepcidin may be useful in clinical practice to detect iron deficiency.",2020,"RESULTS Serum hepcidin concentrations were significantly lower in the early CC group at both time points and in ID infants at 4 months.","['Term infants (n\u2009=\u2009400', 'infancy', 'In all cases with iron depletion or iron deficiency (ID) (as defined in ""Methods"") (n\u2009=\u200930) and 97 randomly selected iron-replete infants', 'infants', 'healthy infants']",['Hepcidin'],"['Levels', 'Serum hepcidin concentrations']","[{'cui': 'C0456128', 'cui_str': 'Term infant'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0231330', 'cui_str': 'Infancy'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0333668', 'cui_str': 'Depletion'}, {'cui': 'C0162316', 'cui_str': 'Iron deficiency anemia'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0021270', 'cui_str': 'Infant'}]","[{'cui': 'C0966897', 'cui_str': 'Hepcidin'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0966897', 'cui_str': 'Hepcidin'}, {'cui': 'C0004268', 'cui_str': 'Attention'}]",400.0,0.122746,"RESULTS Serum hepcidin concentrations were significantly lower in the early CC group at both time points and in ID infants at 4 months.","[{'ForeName': 'Staffan K', 'Initials': 'SK', 'LastName': 'Berglund', 'Affiliation': 'Department of Clinical Sciences, Pediatrics, Umeå University, Umeå, Sweden. staffan.berglund@umu.se.'}, {'ForeName': 'Anna M', 'Initials': 'AM', 'LastName': 'Chmielewska', 'Affiliation': 'Department of Clinical Sciences, Pediatrics, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Magnus', 'Initials': 'M', 'LastName': 'Domellöf', 'Affiliation': 'Department of Clinical Sciences, Pediatrics, Umeå University, Umeå, Sweden.'}, {'ForeName': 'Ola', 'Initials': 'O', 'LastName': 'Andersson', 'Affiliation': 'Department of Clinical Sciences Lund, Pediatrics, Lund University, Lund, Sweden.'}]",Pediatric research,['10.1038/s41390-020-1045-9'] 2794,32610351,Impact of Navigated Task-specific fMRI on Direct Cortical Stimulation.,"BACKGROUND AND STUDY AIMS Cortical mapping (CM) with direct cortical stimulation (DCS) in awake craniotomy is used to preserve cognitive functions such as language. Nevertheless, patient collaboration during this procedure is influenced by previous neurological symptoms and growing discomfort with DCS duration. Our study aimed to evaluate the impact of navigated task-specific functional magnetic resonance imaging (nfMRI) on the practical aspects of DCS. MATERIAL AND METHODS We recruited glioma patients scheduled for awake craniotomy for prior fMRI-based CM, acquired during motor and language tasks (i.e., verb generation, semantic and syntactic decision tasks). Language data was combined to generate a probabilistic map indicating brain regions activated with more than one paradigm. Presurgical neurophysiological language tests (i.e., verb generation, picture naming, and semantic tasks) were also performed. We considered for subsequent study only the patients with a minimum rate of correct responses of 50% in all tests. These patients were then randomized to perform intraoperative language CM either using the multimodal approach (mCM), using nfMRI and DCS combined, or electrical CM (eCM), with DCS alone. DCS was done while the patient performed picture naming and nonverbal semantic decision tasks. Methodological features such as DCS duration, number of stimuli, total delivered stimulus duration per task, and frequency of seizures were analyzed and compared between groups. The correspondence between positive responses obtained with DCS and nfMRI was also evaluated. RESULTS Twenty-one surgeries were included, thirteen of which using mCM (i.e., test group). Patients with lower presurgical neuropsychological performance (correct response rate between 50 and 80% in language tests) showed a decreased DCS duration in comparison with the control group. None of the compared methodological features showed differences between groups. Correspondence between DCS and nfMRI was 100/84% in the identification of the precentral gyrus for motor function/opercular frontal inferior gyrus for language function, respectively. CONCLUSION Navigated fMRI data did not influence DCS in practice. Presurgical language disturbances limited the applicability of DCS mapping in awake surgery.",2020,"Correspondence between DCS and nfMRI was 100/84% in the identification of the precentral gyrus for motor function/opercular frontal inferior gyrus for language function, respectively. ","['awake surgery', 'We recruited glioma patients scheduled for awake craniotomy for prior fMRI-based CM, acquired during motor and language tasks (i.e., verb generation, semantic and syntactic decision tasks', 'Twenty-one surgeries were included, thirteen of which using mCM (i.e., test group']","['navigated task-specific functional magnetic resonance imaging (nfMRI', 'direct cortical stimulation (DCS', 'Navigated Task-specific fMRI', 'intraoperative language CM either using the multimodal approach (mCM), using nfMRI and DCS combined, or electrical CM (eCM), with DCS alone']","['presurgical neuropsychological performance (correct response rate', 'Presurgical neurophysiological language tests (i.e., verb generation, picture naming, and semantic tasks', 'DCS duration, number of stimuli, total delivered stimulus duration per task, and frequency of seizures', 'DCS duration']","[{'cui': 'C0234422', 'cui_str': 'Awake'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0017638', 'cui_str': 'Glioma'}, {'cui': 'C0030703', 'cui_str': 'Patient Schedules'}, {'cui': 'C0521125', 'cui_str': 'For'}, {'cui': 'C0010280', 'cui_str': 'Craniotomy'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C1283195', 'cui_str': 'Mapping - action'}, {'cui': 'C0439661', 'cui_str': 'Acquired'}, {'cui': 'C0347984', 'cui_str': 'During'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C0036612', 'cui_str': 'Semantics'}, {'cui': 'C3715213', 'cui_str': '21'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0439201', 'cui_str': 'um'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0376335', 'cui_str': 'Magnetic Resonance Imaging, Functional'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C1283195', 'cui_str': 'Mapping - action'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0013790', 'cui_str': 'Electricity'}]","[{'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C0023016', 'cui_str': 'Language Tests'}, {'cui': 'C0079411', 'cui_str': 'Generations'}, {'cui': 'C0441468', 'cui_str': 'Photograph'}, {'cui': 'C0036612', 'cui_str': 'Semantics'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0001613', 'cui_str': 'Adrenal cortex structure'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0449802', 'cui_str': 'Number of stimuli'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0234402', 'cui_str': 'Stimulus'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0022333', 'cui_str': 'Jacksonian Seizure'}]",21.0,0.173939,"Correspondence between DCS and nfMRI was 100/84% in the identification of the precentral gyrus for motor function/opercular frontal inferior gyrus for language function, respectively. ","[{'ForeName': 'Joao', 'Initials': 'J', 'LastName': 'Leote', 'Affiliation': 'Faculdade de Ciências da Universidade de Lisboa, Instituto de Biofísica e Engenharia Biomédica, Lisboa, Portugal.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Loução', 'Affiliation': 'Institute of Neurosciences and Medicine, INM 4, Julich, Nordrhein-Westfalen, Germany.'}, {'ForeName': 'Catarina', 'Initials': 'C', 'LastName': 'Viegas', 'Affiliation': 'Department of Neurosurgery and Critical Care, Hospital Garcia de Orta EPE, Almada, Portugal.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Lauterbach', 'Affiliation': 'Department of Neuroradiology, Sociedade Portuguesa de Ressonância Magnética, Lisboa, Portugal.'}, {'ForeName': 'António', 'Initials': 'A', 'LastName': 'Perez-Hick', 'Affiliation': 'Department of Neurosurgery and Critical Care, Hospital Garcia de Orta EPE, Almada, Portugal.'}, {'ForeName': 'Joana', 'Initials': 'J', 'LastName': 'Monteiro', 'Affiliation': 'Department of Neurosurgery and Critical Care, Hospital Garcia de Orta EPE, Almada, Portugal.'}, {'ForeName': 'Rita G', 'Initials': 'RG', 'LastName': 'Nunes', 'Affiliation': 'Department of Bioengineering and Institute for Systems and Robotics (ISR/IST), LARSyS, Universidade de Lisboa Instituto Superior Técnico Campus Alameda, Lisboa, Lisboa, Portugal.'}, {'ForeName': 'Hugo A', 'Initials': 'HA', 'LastName': 'Ferreira', 'Affiliation': 'Faculdade de Ciências da Universidade de Lisboa, Instituto de Biofísica e Engenharia Biomédica, Lisboa, Portugal.'}]","Journal of neurological surgery. Part A, Central European neurosurgery",['10.1055/s-0040-1712496'] 2795,32610358,Neuromuscular Electrical Stimulation Use after Total Knee Arthroplasty Improves Early Return to Function: A Randomized Trial.,"Neuromuscular electrical stimulation (NMES) has been reported as an effective method for quadriceps strengthening which could attenuate muscle loss in the early total knee arthroplasty (TKA) postoperative recovery period. The purpose of this randomized controlled trial was to test whether postoperative use of NMES on TKA patients results in increased quadriceps strength and ultimately improved functional outcomes. This randomized controlled clinical trial of 66 primary TKA patients was conducted at a large academic medical center. Patients were randomized 2:1 into treatment (NMES use, n  = 44) or control arm (no NMES, n  = 22). Patients who used the device for an average of 200 minutes/week or more (starting 1 week postoperative and continuing through week 12) were considered compliant. Baseline measurements and outcomes were recorded at 3, 6, and 12 weeks postoperatively, and included quadriceps strength, range of motion (ROM), resting pain, functional timed up and go (TUG), stair climb test, and knee injury and osteoarthritis outcome score (KOOS) and veterans rand 12-item health survey (VR-12) scores. Patients in the treatment arm (NMES use) experienced quadriceps strength gains over baseline at 3, 6, and 12 weeks following surgery, which were statistically significant compared with controls with quadriceps strength losses at 3 ( p  = 0.050) and 6 weeks ( p  = 0.015). The TUG improvements for patients treated with NMES showed significant improvements at 6 ( p  = 0.018) and 12 weeks ( p  = 0.003) postoperatively. Use of a home-based application-controlled NMES therapy system added to standard of care treatment showed statistically significant improvements in quadriceps strength and TUG following TKA, supporting a quicker return to function.",2020,The TUG improvements for patients treated with NMES showed significant improvements at 6 ( p  = 0.018) and 12 weeks ( p  = 0.003) postoperatively.,"['66 primary TKA patients was conducted at a large academic medical center', 'after Total Knee Arthroplasty Improves Early Return to Function']","['NMES', 'Neuromuscular Electrical Stimulation Use', 'treatment (NMES use, n \u2009=\u200944) or control arm (no NMES', 'Neuromuscular electrical stimulation (NMES']","['quadriceps strength losses', 'quadriceps strength', 'quadriceps strength and TUG', 'quadriceps strength gains', 'quadriceps strength, range of motion (ROM), resting pain, functional timed up and go (TUG), stair climb test, and knee injury and osteoarthritis outcome score (KOOS) and veterans rand 12-item health survey (VR-12) scores', 'functional outcomes']","[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0332156', 'cui_str': 'Return to'}, {'cui': 'C0031843', 'cui_str': 'PH'}]","[{'cui': 'C0013786', 'cui_str': 'Stimulation, Electric'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]","[{'cui': 'C3714552', 'cui_str': 'Debility'}, {'cui': 'C1319201', 'cui_str': 'Timed up and go mobility test'}, {'cui': 'C0080078', 'cui_str': 'Range of joint movement'}, {'cui': 'C0234253', 'cui_str': 'Rest pain'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0432601', 'cui_str': 'Stairs climbed'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C3476088', 'cui_str': 'Knee Injury and Osteoarthritis Outcome Score'}, {'cui': 'C0042610', 'cui_str': 'Veterans'}, {'cui': 'C0018762', 'cui_str': 'Health Surveys'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",66.0,0.0816728,The TUG improvements for patients treated with NMES showed significant improvements at 6 ( p  = 0.018) and 12 weeks ( p  = 0.003) postoperatively.,"[{'ForeName': 'Alison K', 'Initials': 'AK', 'LastName': 'Klika', 'Affiliation': 'Department of Orthopaedic Surgery, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Yakubek', 'Affiliation': 'Department of Orthopaedic Surgery, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Piuzzi', 'Affiliation': 'Department of Orthopaedic Surgery, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Gary', 'Initials': 'G', 'LastName': 'Calabrese', 'Affiliation': 'Department of Orthopaedic Surgery, Cleveland Clinic, Cleveland, Ohio.'}, {'ForeName': 'Wael K', 'Initials': 'WK', 'LastName': 'Barsoum', 'Affiliation': 'Cleveland Clinic Florida, Weston, Florida.'}, {'ForeName': 'Carlos A', 'Initials': 'CA', 'LastName': 'Higuera', 'Affiliation': 'Cleveland Clinic Florida, Weston, Florida.'}]",The journal of knee surgery,['10.1055/s-0040-1713420'] 2796,32610370,Improving pulp revascularization outcomes with buccal fat autotransplantation.,"Several techniques have been introduced to improve the pulp revascularization outcomes. The use of the tissue graft can create more practical tissue regeneration, provides vascular supply and enhances tissue healing. The aim of the present study was to investigate the histologic and molecular outcomes of pulp revascularization with buccal fat autotransplantation. Fifty six open apex roots from 4 dogs aged 4-6 months were randomly allocated to 5 groups of endodontic regeneration models. Group 1 (negative control, n=4); Group 2 (control and without intervention, n=4); Group 3 (blood clot, n=16); Group 4 (buccal fat autotransplantation, n=16); Group 5 (blood clot plus buccal fat autotransplantation, n=16). After three months, the extracted dog teeth were analyzed by histological and immunohistochemical techniques. Furthermore, real-time quantitative polymerase chain reactions were implemented to assess the gene expression profiles of dentin sialophosphoprotein (DSPP), dentin matrix protein (DMP), collagen I (COL1) and alkaline phosphatase (ALP) on regenerated tissue in the root canals. There were no significant differences in the severity of inflammation and necrosis between intervention groups. Immunohistochemical analysis showed significant differences among the study groups in expression level of extracellular glycoproteins such as fibronectin, laminin and tenascin C. Group 5 showed an increase in the expression of DMP1 and COL1 genes. The expression of DSPP gene increased significantly in group 4. The expression of ALP gene increased significantly in group 3. Using this procedure may open new fields of research for REP in which tissue autotransplant particularly adipose tissue, may improve the outcomes of pulp revascularization.",2020,"Immunohistochemical analysis showed significant differences among the study groups in expression level of extracellular glycoproteins such as fibronectin, laminin and tenascin C. Group 5 showed an increase in the expression of DMP1 and COL1 genes.",['Fifty six open apex roots from 4 dogs aged 4-6 months'],"['endodontic regeneration models', 'pulp revascularization with buccal fat autotransplantation', ' Group 2 (control and without intervention, n=4); Group 3 (blood clot, n=16); Group 4 (buccal fat autotransplantation, n=16); Group 5 (blood clot plus buccal fat autotransplantation', 'buccal fat autotransplantation']","['expression of DSPP gene', 'severity of inflammation and necrosis', 'expression of DMP1 and COL1 genes', 'expression of ALP gene', 'gene expression profiles of dentin sialophosphoprotein (DSPP), dentin matrix protein (DMP), collagen I (COL1) and alkaline phosphatase (ALP']","[{'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0140145', 'cui_str': 'APEX1 protein, human'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0012984', 'cui_str': 'Canis lupus familiaris'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0332274', 'cui_str': 'Endodontic'}, {'cui': 'C0034963', 'cui_str': 'Regeneration'}, {'cui': 'C0026339', 'cui_str': 'Biological Models'}, {'cui': 'C0011399', 'cui_str': 'Structure of pulp of tooth'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}, {'cui': 'C0442010', 'cui_str': 'Buccal'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0040736', 'cui_str': 'Autogenous transplantation'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}, {'cui': 'C0087086', 'cui_str': 'Thrombus'}, {'cui': 'C0441876', 'cui_str': 'Group 4'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0914005', 'cui_str': 'dentin sialophosphoprotein'}, {'cui': 'C0017337', 'cui_str': 'Gene'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0027540', 'cui_str': 'Necrosis'}, {'cui': 'C0002059', 'cui_str': 'Alkaline phosphatase'}, {'cui': 'C1449575', 'cui_str': 'Microarray Analysis'}, {'cui': 'C0011429', 'cui_str': 'Dentin structure'}, {'cui': 'C4050026', 'cui_str': 'Matrix'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0041455', 'cui_str': 'Collagen Type I'}]",,0.0184629,"Immunohistochemical analysis showed significant differences among the study groups in expression level of extracellular glycoproteins such as fibronectin, laminin and tenascin C. Group 5 showed an increase in the expression of DMP1 and COL1 genes.","[{'ForeName': 'Saber', 'Initials': 'S', 'LastName': 'Khazaei', 'Affiliation': 'Department of Endodontics and Dental Research Center, Dental Research Institute, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Abbasali', 'Initials': 'A', 'LastName': 'Khademi', 'Affiliation': 'Department of Endodontics and Dental Research Center, Dental Research Institute, Isfahan University of Medical Sciences, Isfahan, Iran.'}, {'ForeName': 'Mahmoud', 'Initials': 'M', 'LastName': 'Torabinejad', 'Affiliation': 'School of Dentistry, Loma Linda University, Loma Linda, CA, United States.'}, {'ForeName': 'Mohammad H', 'Initials': 'MH', 'LastName': 'Nasr Esfahani', 'Affiliation': 'Department of Reproductive Biotechnology, Reproductive Biomedicine Research Center, Royan Institute for Biotechnology, Isfahan, Iran.'}, {'ForeName': 'Mozafar', 'Initials': 'M', 'LastName': 'Khazaei', 'Affiliation': 'Fertility and Infertility Research Center, Health Technology Institute, Kermanshah University of Medical Sciences, Kermanshah, Iran.'}, {'ForeName': 'Sayed Mohammad', 'Initials': 'SM', 'LastName': 'Razavi', 'Affiliation': 'Department of Oral and Maxillofacial Pathology and Dental Implant Research Center, Dental Research Institute, Isfahan University of Medical Sciences, Isfahan, Iran.'}]",Journal of tissue engineering and regenerative medicine,['10.1002/term.3094'] 2797,32610495,Lactobacillus plantarum DR7 Modulated Bowel Movement and Gut Microbiota Associated with Dopamine and Serotonin Pathways in Stressed Adults.,"We have previously reported that the administration of Lactobacillus plantarum DR7 for 12 weeks reduced stress and anxiety in stressed adults as compared to the placebo group, in association with changes along the brain neurotransmitters pathways of serotonin and dopamine-norepinephrine. We now aim to evaluate the effects of DR7 on gut functions, gut microbiota compositional changes, and determine the correlations between microbiota changes and the pathways of brain neurotransmitters. The administration of DR7 prevented an increase of defecation frequency over 12 weeks as compared to the placebo ( p = 0.044), modulating the increase of stress-induced bowel movement. Over 12 weeks, alpha diversity of gut microbiota was higher in DR7 than the placebo group across class ( p = 0.005) and order ( p = 0.018) levels, while beta diversity differed between groups at class and order levels ( p < 0.001). Differences in specific bacterial groups were identified, showing consistency at different taxonomic levels that survived multiplicity correction, along the phyla of Bacteroides and Firmicutes and along the classes of Deltaproteobacteria and Actinobacteria. Bacteroidetes, Bacteroidia, and Bacteroidales which were reduced in abundance in the placebo group showed opposing correlation with gene expression of dopamine beta hydrolase (DBH, dopamine pathway; p < 0.001), while Bacteroidia and Bacteroidales showed correlation with tryptophan hydroxylase-II (TPH2, serotonin pathway; p = 0.001). A correlation was observed between DBH and Firmicutes ( p = 0.002), Clostridia ( p < 0.001), Clostridiales ( p = 0.001), Blautia ( p < 0.001), and Romboutsia ( p < 0.001), which were increased in abundance in the placebo group. Blautia was also associated with TDO ( p = 0.001), whereas Romboutsia had an opposing correlation with TPH2 ( p < 0.001). Deltaproteobacteria and Desulfovibrionales which were decreased in abundance in the placebo group showed opposing correlation with DBH ( p = 0.001), whereas Bilophila was associated with TPH2 ( p = 0.001). Our present data showed that physiological changes induced by L. plantarum DR7 could be associated with changes in specific taxa of the gut microbiota along the serotonin and dopamine pathways.",2020,"Differences in specific bacterial groups were identified, showing consistency at different taxonomic levels that survived multiplicity correction, along the phyla of Bacteroides and Firmicutes and along the classes of Deltaproteobacteria and Actinobacteria.",['Stressed Adults'],"['DR7', 'placebo']","['Lactobacillus plantarum DR7 Modulated Bowel Movement and Gut Microbiota', 'stress-induced bowel movement', 'stress and anxiety', 'TDO', 'Blautia', 'alpha diversity of gut microbiota', 'Romboutsia', 'Bacteroidetes, Bacteroidia, and Bacteroidales', 'Clostridia', 'defecation frequency']","[{'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0317608', 'cui_str': 'Lactobacillus plantarum'}, {'cui': 'C0443264', 'cui_str': 'Modulated'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0041260', 'cui_str': 'Tryptophanase'}, {'cui': 'C2658870', 'cui_str': 'Blautia'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C1634514', 'cui_str': 'Class Bacteroidia'}, {'cui': 'C1080663', 'cui_str': 'Bacteroidales'}, {'cui': 'C0009054', 'cui_str': 'Clostridium'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}]",,0.107604,"Differences in specific bacterial groups were identified, showing consistency at different taxonomic levels that survived multiplicity correction, along the phyla of Bacteroides and Firmicutes and along the classes of Deltaproteobacteria and Actinobacteria.","[{'ForeName': 'Guoxia', 'Initials': 'G', 'LastName': 'Liu', 'Affiliation': 'CAS Key Laboratory of Microbial Physiological and Metabolic Engineering, State Key Laboratory of Microbial Resources, Institute of Microbiology, Chinese Academy of Sciences, Beijing 100101, China.'}, {'ForeName': 'Hui-Xian', 'Initials': 'HX', 'LastName': 'Chong', 'Affiliation': 'School of Industrial Technology, Universiti Sains Malaysia, Penang 11800, Malaysia.'}, {'ForeName': 'Fiona Yi-Li', 'Initials': 'FY', 'LastName': 'Chung', 'Affiliation': 'School of Industrial Technology, Universiti Sains Malaysia, Penang 11800, Malaysia.'}, {'ForeName': 'Yin', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'CAS Key Laboratory of Microbial Physiological and Metabolic Engineering, State Key Laboratory of Microbial Resources, Institute of Microbiology, Chinese Academy of Sciences, Beijing 100101, China.'}, {'ForeName': 'Min-Tze', 'Initials': 'MT', 'LastName': 'Liong', 'Affiliation': 'School of Industrial Technology, Universiti Sains Malaysia, Penang 11800, Malaysia.'}]",International journal of molecular sciences,['10.3390/ijms21134608'] 2798,32610511,Acute Effects of Open Kinetic Chain Exercise Versus Those of Closed Kinetic Chain Exercise on Quadriceps Muscle Thickness in Healthy Adults.,"This study aimed to compare immediate changes in the thickness of the rectus femoris (RF), vastus intermedius (VI), vastus lateralis (VL), vastus medialis (VM), and vastus medialis oblique (VMO) muscles after open kinetic chain exercise (OKCE) and closed kinetic chain exercise (CKCE) and identify the effect of both exercise types on each quadricep muscle for early rehabilitation to prevent knee joint injury. Twenty-six healthy participants (13 males and 13 females) were randomly divided into the OKCE ( n = 13) and CKCE ( n = 13) groups. The thickness of their quadriceps muscles was measured using a portable ultrasonic imaging device before and after exercise in the sequence RF, VI, VL, VM, and VMO. A two-way repeated measures analysis of variance was used to compare the thickness of each component of the quadriceps muscles between the two groups. The thickness of the RF, VL, VM, and VMO muscles increased after OKCE, and the thickness of the VI muscle showed the greatest increase with a medium-large effect size (F = 8.52, p = 0.01, and d = 0.53). The thickness of the VI, VL, VM, and VMO muscles increased after CKCE, and the VMO muscle had the largest effect size (F = 11.71, p = 0.00, and d = 1.02). These results indicate that the thickness of the quadriceps muscles can be selectively improved depending on the type of exercise.",2020,"The thickness of the VI, VL, VM, and VMO muscles increased after CKCE, and the VMO muscle had the largest effect size (F = 11.71, p = 0.00, and d = 1.02).","['Twenty-six healthy participants (13 males and 13 females', 'Healthy Adults']","['Open Kinetic Chain Exercise Versus', 'Closed Kinetic Chain Exercise', 'OKCE', 'CKCE', 'open kinetic chain exercise (OKCE) and closed kinetic chain exercise (CKCE']","['thickness of the RF, VL, VM, and VMO muscles', 'thickness of their quadriceps muscles', 'rectus femoris (RF), vastus intermedius (VI), vastus lateralis (VL), vastus medialis (VM), and vastus medialis oblique (VMO) muscles', 'thickness of the VI, VL, VM, and VMO muscles', 'Quadriceps Muscle Thickness']","[{'cui': 'C0450349', 'cui_str': '26'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C0454289', 'cui_str': 'Open kinetic chain exercises'}, {'cui': 'C0454288', 'cui_str': 'Closed kinetic chain exercises'}]","[{'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0584894', 'cui_str': 'Rectus femoris muscle structure'}, {'cui': 'C0224445', 'cui_str': 'Structure of vastus medialis muscle'}, {'cui': 'C0205315', 'cui_str': 'Oblique'}, {'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0224448', 'cui_str': 'Structure of vastus intermedius muscle'}]",26.0,0.0226761,"The thickness of the VI, VL, VM, and VMO muscles increased after CKCE, and the VMO muscle had the largest effect size (F = 11.71, p = 0.00, and d = 1.02).","[{'ForeName': 'Soul', 'Initials': 'S', 'LastName': 'Cheon', 'Affiliation': 'Department of Kinesiology, Inha University, Incheon 22212, Korea.'}, {'ForeName': 'Joo-Hyun', 'Initials': 'JH', 'LastName': 'Lee', 'Affiliation': 'Department of Kinesiology, Inha University, Incheon 22212, Korea.'}, {'ForeName': 'Hyung-Pil', 'Initials': 'HP', 'LastName': 'Jun', 'Affiliation': 'Department of Physical Education, Dong-A University, Busan 49236, Korea.'}, {'ForeName': 'Yong Woo', 'Initials': 'YW', 'LastName': 'An', 'Affiliation': 'Department of Health and Human Sciences, Loyola Marymount University, Los Angeles, CA 90045, USA.'}, {'ForeName': 'Eunwook', 'Initials': 'E', 'LastName': 'Chang', 'Affiliation': 'Department of Kinesiology, Inha University, Incheon 22212, Korea.'}]",International journal of environmental research and public health,['10.3390/ijerph17134669'] 2799,32610563,Semantic Priming in Mild Cognitive Impairment and Healthy Subjects: Effect of Different Time of Presentation of Word-Pairs.,"INTRODUCTION Semantic memory is impaired in mild cognitive impairment (MCI). Twomain hypotheses about this finding are debated and refer to the degradation of stored knowledgeversus the impairment of semantic access mechanisms. The aim of our study is to evaluate semanticimpairment in MCI versus healthy subjects (HS) by an experiment evaluating semantic priming. METHODS We enrolled 27 MCI and 20 HS. MCI group were divided, according to follow up, intoconverters-MCI and non converters-MCI. The semantic task consisted of 108 pairs of words, 54 ofwhich were semantically associated. Stimuli were presented 250 or 900 ms later the appearance ofthe target in a randomized manner. Data were analyzed using factorial ANOVA. RESULTS Both HSand MCI answered more quickly for word than for non-word at both stimulus onset asynchrony(SOA) intervals. At 250 ms, both MCI and HS experienced a shorter time of response for relatedwordthan for unrelated words (priming effect), while only the converters-MCI subgroup lost thepriming effect. Further, we observed a rather larger Cohen's d effect size in non converters-MCIthan in converters-MCI. CONCLUSION Our data, and in particular the absence of a semantic primingeffect in converters-MCI, could reflect the impairment of semantic knowledge rather than theaccessibility of semantic stores in MCI individuals that progress to dementia.",2020,Both HSand MCI answered more quickly for word than for non-word at both stimulus onset asynchrony(SOA) intervals.,"['Mild Cognitive Impairment and Healthy Subjects', 'mild cognitive impairment (MCI', 'healthy subjects (HS']","['Semantic Priming', 'HSand MCI', 'MCI']",['shorter time of response for relatedwordthan'],"[{'cui': 'C1270972', 'cui_str': 'Mild cognitive disorder'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0036612', 'cui_str': 'Semantics'}, {'cui': 'C1270972', 'cui_str': 'Mild cognitive disorder'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",54.0,0.025956,Both HSand MCI answered more quickly for word than for non-word at both stimulus onset asynchrony(SOA) intervals.,"[{'ForeName': 'Valeria', 'Initials': 'V', 'LastName': 'Guglielmi', 'Affiliation': 'Neurology Unit, Fondazione Policlinico Agostino Gemelli-IRCCS, 00168 Rome, Italy.'}, {'ForeName': 'Davide', 'Initials': 'D', 'LastName': 'Quaranta', 'Affiliation': 'Neurology Unit, Fondazione Policlinico Agostino Gemelli-IRCCS, 00168 Rome, Italy.'}, {'ForeName': 'Ilaria', 'Initials': 'I', 'LastName': 'Mega', 'Affiliation': 'Department of Neuroscience, Catholic University of Sacred Heart, 00168 Rome, Italy.'}, {'ForeName': 'Emanuele Maria', 'Initials': 'EM', 'LastName': 'Costantini', 'Affiliation': 'Department of Neuroscience, Catholic University of Sacred Heart, 00168 Rome, Italy.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Carrarini', 'Affiliation': 'Department of Neuroscience, Catholic University of Sacred Heart, 00168 Rome, Italy.'}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Innocenti', 'Affiliation': 'Department of Neuroscience, Catholic University of Sacred Heart, 00168 Rome, Italy.'}, {'ForeName': 'Camillo', 'Initials': 'C', 'LastName': 'Marra', 'Affiliation': 'Department of Neuroscience, Catholic University of Sacred Heart, 00168 Rome, Italy.'}]",Journal of personalized medicine,['10.3390/jpm10030057'] 2800,32610568,The Acute Impact of External Compression on Back Squat Performance in Competitive Athletes.,"The aim of the present study was to evaluate the effects of external compression with blood flow restriction on power output and bar velocity changes during the back-squat exercise (SQ). The study included 10 judo athletes (age = 28.4 ± 5.8 years; body mass = 81.3 ± 13.1 kg; SQ one-repetition maximum (1-RM) 152 ± 34 kg; training experience 10.7 ± 2.3 years). METHODS The experiment was performed following a randomized crossover design, where each participant performed three different exercise protocols: (1) control, without external compression (CONT); (2) intermittent external compression with pressure of 100% arterial occlusion pressure (AOP) (EC-100); and (3) intermittent external compression with pressure of 150% AOP (EC-150). To assess the differences between conditions, the participants performed 3 sets of 3 repetitions of the SQ at 70% 1-RM. The differences in peak power output (PP), mean power output (MP), peak bar velocity (PV), and mean bar velocity (MV) between the three conditions were examined using repeated measures two-way ANOVA. RESULTS The post hoc analysis for the main effect of conditions showed a significant increase in PP ( p = 0.03), PV ( p = 0.02), MP ( p = 0.04), and MV ( p = 0.03), for the EC-150, compared to the CONT. Furthermore, a statistically significant increase in PP ( p = 0.04), PV ( p = 0.03), MP ( p = 0.02), and MV ( p = 0.01) were observed for the EC-150 compared to EC-100. There were no significant changes in PP, PV, MP, and MV, between EC-100 and CONT conditions. CONCLUSION The results indicate that the use of extremely high-pressure external compression (150% AOP) during high-loaded (70% 1-RM) lower limb resistance exercise elicits an acute increase in power output and bar velocity.",2020,"The post hoc analysis for the main effect of conditions showed a significant increase in PP ( p = 0.03),","['10 judo athletes (age = 28.4 ± 5.8 years; body mass = 81.3 ± 13.1 kg', 'Competitive Athletes']","['exercise protocols: (1) control, without external compression (CONT); (2) intermittent external compression with pressure of 100% arterial occlusion pressure (AOP) (EC-100); and (3) intermittent external compression with pressure of 150% AOP (EC-150', 'external compression with blood flow restriction', 'back-squat exercise (SQ', 'External Compression']","['PP', 'PV', 'PP, PV, MP, and MV, between EC-100 and CONT conditions', 'power output and bar velocity changes', 'power output and bar velocity', 'peak power output (PP), mean power output (MP), peak bar velocity (PV), and mean bar velocity (MV', 'Back Squat Performance']","[{'cui': 'C0079650', 'cui_str': 'Judo'}, {'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517796', 'cui_str': '5.8'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0425273', 'cui_str': 'Competitive athlete'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0264995', 'cui_str': 'Occlusion of artery'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0158996', 'cui_str': 'Anemia of prematurity'}, {'cui': 'C0232338', 'cui_str': 'Vascular flow'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0241236', 'cui_str': 'Does squat'}]","[{'cui': 'C0445194', 'cui_str': 'Power output'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0001643', 'cui_str': 'Beta-2 adrenergic receptor'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205101', 'cui_str': 'External'}, {'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0264995', 'cui_str': 'Occlusion of artery'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0241236', 'cui_str': 'Does squat'}]",10.0,0.0501652,"The post hoc analysis for the main effect of conditions showed a significant increase in PP ( p = 0.03),","[{'ForeName': 'Mariola', 'Initials': 'M', 'LastName': 'Gepfert', 'Affiliation': 'Institute of Sport Sciences, Jerzy Kukuczka Academy of Physical Education in Katowice, 40-065 Katowice, Poland.'}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Krzysztofik', 'Affiliation': 'Institute of Sport Sciences, Jerzy Kukuczka Academy of Physical Education in Katowice, 40-065 Katowice, Poland.'}, {'ForeName': 'Maciej', 'Initials': 'M', 'LastName': 'Kostrzewa', 'Affiliation': 'Institute of Sport Sciences, Jerzy Kukuczka Academy of Physical Education in Katowice, 40-065 Katowice, Poland.'}, {'ForeName': 'Jakub', 'Initials': 'J', 'LastName': 'Jarosz', 'Affiliation': 'Institute of Sport Sciences, Jerzy Kukuczka Academy of Physical Education in Katowice, 40-065 Katowice, Poland.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Trybulski', 'Affiliation': 'Department of Medical Sciences, The Wojciech Korfanty School of Economics, 40-065 Katowice, Poland.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Zajac', 'Affiliation': 'Institute of Sport Sciences, Jerzy Kukuczka Academy of Physical Education in Katowice, 40-065 Katowice, Poland.'}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Wilk', 'Affiliation': 'Institute of Sport Sciences, Jerzy Kukuczka Academy of Physical Education in Katowice, 40-065 Katowice, Poland.'}]",International journal of environmental research and public health,['10.3390/ijerph17134674'] 2801,32610573,The Performance Effect of Scheduled Carbohydrate and Caffeine Intake during Simulated Team Sport Match-Play.,"The aim of the current investigation was to identify the effects of scheduled carbohydrate (CHO) and caffeine (CAF) supplementation on simulated team sport match-play performance. Ten male hurling players completed three hurling match-play simulation protocols (HSP) performed 7 days apart in a double-blind, randomized design. Supplementation included CHO, CHO + CAF, and placebo (PLA). In a randomized order, participants ingested either a 6% CHO solution, a PLA solution of similar taste, or a combined intake of 6% CHO solution + 200 mg CAF capsule. At specific time points (Pre-0 min; half time (HT)-30 min; full time (FT)-60 min), participants completed a repeated sprint protocol (RAST; 12 × 20 m). Physiological [% maximal oxygen uptake (%VO 2max ), % mean oxygen uptake (%VO 2mean ), % maximal heart rate (%HR max ), % mean heart rate (%HR mean ), respiratory exchange ratio (RER), and blood lactate (BLa)] and performance [(best sprint time (RSA best ), mean sprint time (RSA mean ), and rate of perceived exertion (RPE)] variables were monitored throughout each simulation. Non-significant differences were observed between supplement trials (CHO, CHO + CAF, and PLA) for BLa (η 2 = 0.001, small ), %VO 2max (η 2 = 0.001, small ), %VO 2mean (η 2 = 0.004, small ), %HR max (η 2 = 0.007, small ), %HR mean (η 2 = 0.018, small ), RER (η 2 = 0.007, small ), RPE (η 2 = 0.007, small ), and RSA best (η 2 = 0.050, small ). RSA mean performance significantly improved in CHO + CAF trials compared to PLA, with sprint times significantly improved from Pre to FT also (η 2 = 0.135, medium ). A significant difference was observed in BLa between time points (Pre, HT, and FT) (η 2 = 0.884, large ) in % HRmax (η 2 = 0.202, medium ), %HR mean (η 2 = 0.477, large ), and RER (η 2 = 0.554, large ) across halves and in RPE across time points (η 2 = 0.670, large ). Our data provide novel data regarding the effects of CHO and CAF supplementation on team sport performance, with co-ingestion of CHO + CAF reducing the decrement in repeated sprint performance compared to PLA.",2020,"RSA mean performance significantly improved in CHO + CAF trials compared to PLA, with sprint times significantly improved from Pre to FT also (η 2 = 0.135, medium ).",['Ten male hurling players completed three'],"['scheduled carbohydrate (CHO) and caffeine (CAF) supplementation', 'Scheduled Carbohydrate and Caffeine Intake', 'CHO and CAF supplementation', '6% CHO solution, a PLA solution of similar taste, or a combined intake of 6% CHO solution + 200 mg CAF capsule', 'hurling match-play simulation protocols (HSP']","[' mean oxygen uptake', 'CHO, CHO + CAF, and placebo (PLA', 'maximal heart rate', 'RER', 'repeated sprint performance', 'HR mean ', 'supplement trials (CHO, CHO + CAF, and PLA) for BLa', 'BLa between time points (Pre, HT, and FT', 'RSA mean performance', 'Physiological [% maximal oxygen uptake', 'mean heart rate (%HR mean ), respiratory exchange ratio (RER), and blood lactate (BLa)] and performance [(best sprint time (RSA best ), mean sprint time (RSA mean ), and rate of perceived exertion (RPE)] variables']","[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}, {'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0054889', 'cui_str': 'CAV protocol'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0456170', 'cui_str': 'Left atrial pressure'}, {'cui': 'C0039336', 'cui_str': 'Finding of sense of taste'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0018850', 'cui_str': 'Heat-Shock Protein'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}, {'cui': 'C0054889', 'cui_str': 'CAV protocol'}, {'cui': 'C0006644', 'cui_str': 'Caffeine'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0456170', 'cui_str': 'Left atrial pressure'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0230779', 'cui_str': 'Granular endoplasmic reticulum'}, {'cui': 'C0205341', 'cui_str': 'Repeat'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0574531', 'cui_str': 'Blackfoot language'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0205463', 'cui_str': 'Physiologic'}, {'cui': 'C0429702', 'cui_str': 'Respiratory quotient'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0015264', 'cui_str': 'Exertion'}, {'cui': 'C0439828', 'cui_str': 'Variable'}]",10.0,0.234824,"RSA mean performance significantly improved in CHO + CAF trials compared to PLA, with sprint times significantly improved from Pre to FT also (η 2 = 0.135, medium ).","[{'ForeName': 'John', 'Initials': 'J', 'LastName': 'Keane', 'Affiliation': 'Gaelic Sports Research Centre, Department of Science, Tallaght Campus, Technological University Dublin, 24, D24 FKT9 Dublin, Ireland.'}, {'ForeName': 'Aidan', 'Initials': 'A', 'LastName': 'Shovlin', 'Affiliation': 'Gaelic Sports Research Centre, Department of Science, Tallaght Campus, Technological University Dublin, 24, D24 FKT9 Dublin, Ireland.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Devenney', 'Affiliation': 'Gaelic Sports Research Centre, Department of Science, Tallaght Campus, Technological University Dublin, 24, D24 FKT9 Dublin, Ireland.'}, {'ForeName': 'Shane', 'Initials': 'S', 'LastName': 'Malone', 'Affiliation': 'Gaelic Sports Research Centre, Department of Science, Tallaght Campus, Technological University Dublin, 24, D24 FKT9 Dublin, Ireland.'}, {'ForeName': 'Damien', 'Initials': 'D', 'LastName': 'Young', 'Affiliation': 'Limerick Institute of Technology, Thurles Campus, V94 EC5T Limerick, Ireland.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Coratella', 'Affiliation': 'Department of Biomedical Sciences for Health, Università degli Studi di Milano, 20133 Milan, Italy.'}, {'ForeName': 'Kieran', 'Initials': 'K', 'LastName': 'Collins', 'Affiliation': 'Gaelic Sports Research Centre, Department of Science, Tallaght Campus, Technological University Dublin, 24, D24 FKT9 Dublin, Ireland.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Shortall', 'Affiliation': 'Gaelic Sports Research Centre, Department of Science, Tallaght Campus, Technological University Dublin, 24, D24 FKT9 Dublin, Ireland.'}]",Nutrients,['10.3390/nu12071926'] 2802,32610640,Be a Mom 's Efficacy in Enhancing Positive Mental Health among Postpartum Women Presenting Low Risk for Postpartum Depression: Results from a Pilot Randomized Trial.,"In this study, we conducted a preliminary investigation of the efficacy of Be a Mom , a web-based self-guided intervention, in enhancing positive mental health among postpartum women at low risk for postpartum depression. Additionally, we examined Be a Mom 's efficacy regarding secondary outcomes as well as its acceptability and adherence. A total of 367 participants were randomly assigned to the Be a Mom group ( n = 191) or to the waiting-list control group ( n = 176) and completed baseline (T1) and postintervention (T2) assessments. The intervention group reported significant increases in positive mental health between T1 and T2 compared to the control group. Additionally, group effects were found for depressive and anxiety symptoms. A significantly higher proportion of participants in the Be a Mom group had an improvement trajectory (from not flourishing at T1 to flourishing at T2). A total of 62 (32.5%) women completed Be a Mom , and most would use it again if needed ( n = 82/113; 72.6%). This study provides preliminary evidence of Be a Mom 's efficacy in increasing positive mental health among low-risk postpartum women. Our findings support mental health promotion strategies in the postpartum period and highlight the important role of web-based CBT interventions.",2020,The intervention group reported significant increases in positive mental health between T1 and T2 compared to the control group.,"['Postpartum Women Presenting Low Risk for Postpartum Depression', 'postpartum women at low risk for postpartum depression', 'low-risk postpartum women', 'A total of 367 participants', 'A total of 62 (32.5%) women completed Be a Mom']",['waiting-list control group'],"['depressive and anxiety symptoms', 'acceptability and adherence', 'positive mental health']","[{'cui': 'C0032804', 'cui_str': 'Postpartum Women'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0221074', 'cui_str': 'Postpartum depression'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517710', 'cui_str': '32.5'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C1278569', 'cui_str': 'WAS A'}, {'cui': 'C1442163', 'cui_str': 'MoM'}]","[{'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}]",367.0,0.0973773,The intervention group reported significant increases in positive mental health between T1 and T2 compared to the control group.,"[{'ForeName': 'Fabiana', 'Initials': 'F', 'LastName': 'Monteiro', 'Affiliation': 'Center for Research in Neuropsychology and Cognitive Behavioral Intervention (CINEICC), Faculty of Psychology and Educational Sciences, the University of Coimbra Rua do Colégio Novo, 3000-315 Coimbra, Portugal.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Pereira', 'Affiliation': 'Center for Research in Neuropsychology and Cognitive Behavioral Intervention (CINEICC), Faculty of Psychology and Educational Sciences, the University of Coimbra Rua do Colégio Novo, 3000-315 Coimbra, Portugal.'}, {'ForeName': 'Maria Cristina', 'Initials': 'MC', 'LastName': 'Canavarro', 'Affiliation': 'Center for Research in Neuropsychology and Cognitive Behavioral Intervention (CINEICC), Faculty of Psychology and Educational Sciences, the University of Coimbra Rua do Colégio Novo, 3000-315 Coimbra, Portugal.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Fonseca', 'Affiliation': 'Center for Research in Neuropsychology and Cognitive Behavioral Intervention (CINEICC), Faculty of Psychology and Educational Sciences, the University of Coimbra Rua do Colégio Novo, 3000-315 Coimbra, Portugal.'}]",International journal of environmental research and public health,['10.3390/ijerph17134679'] 2803,32610647,Intermittent Hypoxic Exposure with High Dose of Arginine Impact on Circulating Mediators of Tissue Regeneration.,"Intermittent exposure to hypoxia (IHE) increases production of reactive oxygen and nitrogen species which, as signalling molecules, participate in tissue injury-repair-regeneration cascade. The process is also stimulated by arginine whose bioavailability is a limiting factor for NO synthesis. The effects of IHE in combination with arginine (Arg) intake on myogenesis and angiogenesis mediators were examined in a randomized and placebo-controlled trial. Blood samples were collected from 38 elite athletes on the 1st, 7th and 14th days during the training camp. The oral doses of arginine (2 × 6 g/day) and/or IHE using hypoxicator GO2Altitude (IHE and Arg/IHE) were applied. Serum NO and H 2 O 2 concentrations increased significantly and were related to muscle damage (CK activity >900 IU/mL) in IHE and Arg/IHE compared to placebo. The changes in NO and H 2 O 2 elevated the levels of circulating growth factors such as HGF, IHG-1, PDGF BB , BDNF, VEGF and EPO. Modification of the lipid profile, especially reduced non-HDL, was an additional beneficial effect of hypoxic exposure with arginine intake. Intermittent hypoxic exposure combined with high-dose arginine intake was demonstrated to affect circulating mediators of injury-repair-regeneration. Therefore, a combination of IHE and arginine seems to be a potential therapeutic and non-pharmacological method to modulate the myogenesis and angiogenesis in elite athletes.",2020,2 O 2 concentrations increased significantly and were related to muscle damage (CK activity >900 IU/mL) in IHE and Arg/IHE compared to placebo.,"['elite athletes', '38 elite athletes on the 1st, 7th and 14th days during the training camp']","['Intermittent exposure to hypoxia (IHE', 'arginine', 'Intermittent hypoxic exposure combined with high-dose arginine intake', 'IHE using hypoxicator GO2Altitude (IHE and Arg/IHE', 'IHE', 'arginine (Arg) intake', 'placebo']","['circulating mediators of injury-repair-regeneration', 'Circulating Mediators of Tissue Regeneration', 'Serum', 'levels of circulating growth factors such as HGF, IHG-1, PDGF BB , BDNF, VEGF and EPO', 'muscle damage (CK activity', 'myogenesis and angiogenesis mediators']","[{'cui': 'C0238703', 'cui_str': 'Athletes'}, {'cui': 'C0205435', 'cui_str': 'First'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0001455', 'cui_str': 'Cyclic AMP'}]","[{'cui': 'C0205267', 'cui_str': 'Intermittent'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}, {'cui': 'C0242184', 'cui_str': 'Hypoxia'}, {'cui': 'C0003765', 'cui_str': 'Arginine'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C3251814', 'cui_str': 'Measurement of fluid intake'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0175630', 'cui_str': 'Circulating'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0034963', 'cui_str': 'Regeneration'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0018284', 'cui_str': 'Growth factor'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0379135', 'cui_str': 'Becaplermin'}, {'cui': 'C0107103', 'cui_str': 'Brain-Derived Neurotrophic Factor'}, {'cui': 'C0078058', 'cui_str': 'Vascular endothelial growth factor'}, {'cui': 'C0014822', 'cui_str': 'erythropoietin'}, {'cui': 'C0410158', 'cui_str': 'Muscle damage NOS'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0596997', 'cui_str': 'Myogenesis'}]",38.0,0.025484,2 O 2 concentrations increased significantly and were related to muscle damage (CK activity >900 IU/mL) in IHE and Arg/IHE compared to placebo.,"[{'ForeName': 'Agnieszka', 'Initials': 'A', 'LastName': 'Zembron-Lacny', 'Affiliation': 'Department of Applied and Clinical Physiology, Collegium Medicum University of Zielona Gora, 65-417 Zielona Gora, Poland.'}, {'ForeName': 'Artur', 'Initials': 'A', 'LastName': 'Gramacki', 'Affiliation': 'Faculty of Computer, Electrical and Control Engineering. Institute of Control and Computation Engineering University of Zielona Gora, 65-417 Zielona Gora Poland.'}, {'ForeName': 'Edyta', 'Initials': 'E', 'LastName': 'Wawrzyniak-Gramacka', 'Affiliation': 'Department of Applied and Clinical Physiology, Collegium Medicum University of Zielona Gora, 65-417 Zielona Gora, Poland.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Tylutka', 'Affiliation': 'Department of Applied and Clinical Physiology, Collegium Medicum University of Zielona Gora, 65-417 Zielona Gora, Poland.'}, {'ForeName': 'Natalia', 'Initials': 'N', 'LastName': 'Hertmanowska', 'Affiliation': 'Department of Applied and Clinical Physiology, Collegium Medicum University of Zielona Gora, 65-417 Zielona Gora, Poland.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Kasperska', 'Affiliation': 'Department of Physiology, University School of Physical Education in Poznan, 61-871 Poznan, Poland.'}, {'ForeName': 'Miłosz', 'Initials': 'M', 'LastName': 'Czuba', 'Affiliation': 'Department of Applied and Clinical Physiology, Collegium Medicum University of Zielona Gora, 65-417 Zielona Gora, Poland.'}]",Nutrients,['10.3390/nu12071933'] 2804,32610672,Effects of Bag Mask Ventilation and Advanced Airway Management on Adherence to Ventilation Recommendations and Chest Compression Fraction: A Prospective Randomized Simulator-Based Trial.,"The role of advanced airway management (AAM) in cardiopulmonary resuscitation (CPR) is currently debated as observational studies reported better outcomes after bag-mask ventilation (BMV), and the only prospective randomized trial was inconclusive. Adherence to CPR guidelines ventilation recommendations is unknown and difficult to assess in clinical trials. This study compared AAM and BMV with regard to adherence to ventilation recommendations and chest compression fractions in simulated cardiac arrests. A total of 154 teams of 3-4 physicians were randomized to perform CPR with resuscitation equipment restricting airway management to BMV only or equipment allowing for all forms of AAM. BMV teams ventilated 6 ± 6/min and AAM teams 19 ± 8/min (range 3-42/min; p < 0.0001 vs. BMV). 68/78 BMV teams and 23/71 AAM teams adhered to the ventilation recommendations ( p < 0.0001). BMV teams had lower compression fractions than AAM teams (78 ± 7% vs. 86 ± 6%, p < 0.0001) resulting entirely from higher no-flow times for ventilation (9 ± 4% vs. 3 ± 3 %; p < 0.0001). Compared to BMV, AAM leads to significant hyperventilation and lower adherence to ventilation recommendations but favourable compression fractions. The cumulative effect of deviations from ventilation recommendations has the potential to blur findings in clinical trials.",2020,68/78 BMV teams and 23/71 AAM teams adhered to the ventilation recommendations ( p < 0.0001).,['A total of 154 teams of 3-4 physicians'],"['bag-mask ventilation (BMV', 'advanced airway management (AAM', 'cardiopulmonary resuscitation (CPR', 'CPR with resuscitation equipment restricting airway management to BMV only or equipment allowing for all forms of AAM', 'Bag Mask Ventilation and Advanced Airway Management']","['compression fractions', 'Adherence to Ventilation Recommendations and Chest Compression Fraction']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C5191279', 'cui_str': '154'}, {'cui': 'C0442757', 'cui_str': '3/4'}, {'cui': 'C0031831', 'cui_str': 'Physician'}]","[{'cui': 'C0179196', 'cui_str': 'Bag'}, {'cui': 'C0024861', 'cui_str': 'Mask'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0150126', 'cui_str': 'Airway management'}, {'cui': 'C0007203', 'cui_str': 'Cardiopulmonary resuscitation'}, {'cui': 'C0035273', 'cui_str': 'Resuscitation'}, {'cui': 'C0014672', 'cui_str': 'Equipment'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0205431', 'cui_str': 'Formed'}]","[{'cui': 'C0332459', 'cui_str': 'Compression'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0035203', 'cui_str': 'Respiratory function'}, {'cui': 'C0817096', 'cui_str': 'Thoracic'}]",,0.0244432,68/78 BMV teams and 23/71 AAM teams adhered to the ventilation recommendations ( p < 0.0001).,"[{'ForeName': 'Lea', 'Initials': 'L', 'LastName': 'Vogt', 'Affiliation': 'Department of Anaesthesiology, Bethesda Hospital, 47053 Duisburg, Germany.'}, {'ForeName': 'Timur', 'Initials': 'T', 'LastName': 'Sellmann', 'Affiliation': 'Department of Anaesthesiology, Bethesda Hospital, 47053 Duisburg, Germany.'}, {'ForeName': 'Dietmar', 'Initials': 'D', 'LastName': 'Wetzchewald', 'Affiliation': 'Institution for Emergency Medicine, 59755 Arnsberg, Germany.'}, {'ForeName': 'Heidrun', 'Initials': 'H', 'LastName': 'Schwager', 'Affiliation': 'Institution for Emergency Medicine, 59755 Arnsberg, Germany.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Russo', 'Affiliation': 'Department of Anaesthesiology 1, Witten/Herdecke University, 58455 Witten, Germany.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Marsch', 'Affiliation': 'Department of Intensive Care, University Hospital, 4031 Basel, Switzerland.'}]",Journal of clinical medicine,['10.3390/jcm9072045'] 2805,32610815,Using Open Public Meetings and Elections to Promote Inward Transparency and Accountability: Lessons From Zambia.,"BACKGROUND Community-led governance can ensure that leaders are accountable to the populations they serve and strengthen health systems for maternal care. A key aspect of democratic accountability is electing respective governance bodies, in this case community boards, and holding public meetings to inform community members about actions taken on their behalf. After helping build and open 10 maternity waiting homes (MWHs) in rural Zambia as part of a randomized controlled trial, we assisted community governance committees to plan and execute annual meetings to present performance results and, where needed, to elect new board members. METHODS We applied a principally qualitative design using observation and analysis of written documentation of public meetings to answer our research question: how do governance committees enact inward transparency and demonstrate accountability to their communities. The analysis measured participation and stakeholder representation at public meetings, the types and purposes of accountability sought by community members as evidenced by questions asked of the governance committee, and responsiveness of the governance committee to issues raised at public meetings. RESULTS Public meetings were attended by 6 out of 7 possible stakeholder groups, and reports were generally transparent. Stakeholders asked probing questions focused mainly on financial performance. Governance committee members were responsive to questions raised by participants, with 59% of answers rated as fully or mostly responsive (showing understanding of and answering the question). Six of the 10 sites held elections to re-elect or replace governance committee members. Only 2 sites reached the target set by local stakeholder committees of 50% female membership, down from 3 at formation. To further improve transparency and accountability, community governance committees need to engage in advance preparation of reports, and should consult with stakeholders on broader measures for performance assessment. Despite receiving training, community-level governance committees lacked understanding of the strategic purpose of open public meetings and elections, and how these relate to democratic accountability. They were therefore not motivated to engage in tactics to manage stakeholders effectively. CONCLUSION While open meetings and elections have potential to enhance good governance at the community level, continuous training and mentoring are needed to build capacity and enhance sustainability.",2020,"Governance committee members were responsive to questions raised by participants, with 59% of answers rated as fully or mostly responsive (showing understanding of and answering the question).",['10 maternity waiting homes (MWHs) in rural Zambia'],[],[],"[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0043445', 'cui_str': 'Zambia'}]",[],[],,0.0274592,"Governance committee members were responsive to questions raised by participants, with 59% of answers rated as fully or mostly responsive (showing understanding of and answering the question).","[{'ForeName': 'Taryn', 'Initials': 'T', 'LastName': 'Vian', 'Affiliation': 'School of Nursing and Health Professions, University of San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Rachel M', 'Initials': 'RM', 'LastName': 'Fong', 'Affiliation': 'Department of Global Health, Boston University School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Jeanette L', 'Initials': 'JL', 'LastName': 'Kaiser', 'Affiliation': 'Department of Global Health, Boston University School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Misheck', 'Initials': 'M', 'LastName': 'Bwalya', 'Affiliation': 'Department of Research, Right to Care Zambia, Lusaka, Zambia.'}, {'ForeName': 'Viviane I R', 'Initials': 'VIR', 'LastName': 'Sakanga', 'Affiliation': 'Department of Programs, Amref Health Africa, Lusaka, Zambia.'}, {'ForeName': 'Thandiwe', 'Initials': 'T', 'LastName': 'Ngoma', 'Affiliation': 'Department of Research, Right to Care Zambia, Lusaka, Zambia.'}, {'ForeName': 'Nancy A', 'Initials': 'NA', 'LastName': 'Scott', 'Affiliation': 'Department of Global Health, Boston University School of Public Health, Boston, MA, USA.'}]",International journal of health policy and management,['10.34172/ijhpm.2020.84'] 2806,32610864,"A Prospective, Randomized, Interventional Study of Oral Iron Supplementation Comparing Daily Dose with Alternate Day Regimen Using Hepcidin as a Biomarker in Iron Deficiency Anemia.","Aim To assess effect of daily vis-a-vis alternate day oral iron therapy in terms of hemoglobin, reticulocyte hemoglobin equivalent (RET-He) and GI side effects using hepcidin as a biomarker. Methods A hospital based randomized interventional two-arm analytical study was done among patients of IDA (20 in each group). The study population was divided into two groups by randomisation. Group 1 received oral iron supplements on alternate day and Group 2 received iron supplements daily. Hemoglobin, RET-He, Serum ferritin and Hepcidin level were assessed. Results On day 2nd, the rise in Hepcidin was not significant from base line in alternate day therapy group but was significantly increased in daily therapy group. On day 3, the rise in hepcidin was significant from base line in both the groups but the mean change in hepcidin was more in daily therapy group. RET-He began increasing on day 2nd in both the groups. In alternate day therapy group, the rise in RET-He was significant from base line from the day 2nd onwards while the rise in RET-He in daily therapy group was not significant even on day 3. In alternate day iron therapy group, the mean increase in hemoglobin on day 21th (1.58 ±0.53 gm/dl) was significantly more than mean increase among daily therapy (0.41 ± 0.25 gm/dl, P <0.05). Conclusion Alternate day single tablet dosing schedule of oral iron therapy (60mg of elemental iron, ferrous sulfate) was more effective and better tolerated (gastrointestinal side effects) compared to daily supplementation in IDA.",2020,"On day 2nd, the rise in Hepcidin was not significant from base line in alternate day therapy group but was significantly increased in daily therapy group.",['patients of IDA (20 in each group'],"['daily vis-a-vis alternate day oral iron therapy', 'Oral Iron Supplementation', 'oral iron therapy (60mg of elemental iron, ferrous sulfate', 'oral iron supplements']","['Hemoglobin, RET-He, Serum ferritin and Hepcidin level', 'mean increase in hemoglobin', 'effective and better tolerated (gastrointestinal side effects', 'hemoglobin, reticulocyte hemoglobin equivalent (RET-He) and GI side effects', 'rise in Hepcidin', 'rise in RET-He', 'rise in hepcidin', 'mean change in hepcidin']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0020789', 'cui_str': 'Idarubicin'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C1571809', 'cui_str': 'Visceral manipulation'}, {'cui': 'C0558287', 'cui_str': 'Alternate days'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C3537005', 'cui_str': 'Iron supplement therapy'}, {'cui': 'C0302583', 'cui_str': 'Iron'}, {'cui': 'C0060282', 'cui_str': 'ferrous sulfate'}, {'cui': 'C0721124', 'cui_str': 'Iron supplement'}]","[{'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C4049225', 'cui_str': 'Reticulocyte haemoglobin equivalent'}, {'cui': 'C0696113', 'cui_str': 'Serum ferritin measurement'}, {'cui': 'C0966897', 'cui_str': 'Hepcidin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0392747', 'cui_str': 'Changing'}]",,0.0337129,"On day 2nd, the rise in Hepcidin was not significant from base line in alternate day therapy group but was significantly increased in daily therapy group.","[{'ForeName': 'Sudhir', 'Initials': 'S', 'LastName': 'Mehta', 'Affiliation': 'Senior Professor, SMS Medical College, Jaipur, Rajasthan.'}, {'ForeName': 'Bhawani Shankar', 'Initials': 'BS', 'LastName': 'Sharma', 'Affiliation': 'Resident, Department of Medicine, SMS Medical College, Jaipur, Rajasthan.'}, {'ForeName': 'Sandhya', 'Initials': 'S', 'LastName': 'Gulati', 'Affiliation': 'Senior Professor, SMS Medical College, Jaipur, Rajasthan.'}, {'ForeName': 'Nidhi', 'Initials': 'N', 'LastName': 'Sharma', 'Affiliation': 'Assistant Professor, Department of Pathology, SMS Medical College, Jaipur, Rajasthan.'}, {'ForeName': 'Laxmi Kant', 'Initials': 'LK', 'LastName': 'Goyal', 'Affiliation': 'Assistant Professor, Geriatric Medicine, SMS Medical College, Jaipur, Rajasthan.'}, {'ForeName': 'Shaurya', 'Initials': 'S', 'LastName': 'Mehta', 'Affiliation': 'Senior Resident, Department of Medicine, SMS Medical College, Jaipur, Rajasthan.'}]",The Journal of the Association of Physicians of India,[] 2807,32611284,Alteplase for Acute Ischemic Stroke in Patients Aged >80 Years: Pooled Analyses of Individual Patient Data.,"BACKGROUND/PURPOSE Expert guidelines specify no upper age limit for alteplase for thrombolysis of acute ischemic stroke (AIS) but, until recently, European regulatory criteria restricted its use to patients aged 18 to 80 years. We performed pooled analyses of randomized controlled trial (RCT) and registry data to evaluate the benefit-risk profile of alteplase for AIS among patients aged >80 years to support a regulatory application to lift the upper age restriction. METHODS Individual patient data were evaluated from 7 randomized trials of alteplase (0.9 mg/kg) versus placebo or open control for AIS, and the European SITS-UTMOST registry database. Clinical outcomes, including good functional outcome (score 0-1, modified Rankin Scale day 90 or Oxford Handicap Score day 180), were evaluated in the full RCT and registry populations, and specified age-based subgroups (≤80 or >80 years) who met existing European regulatory criteria for alteplase, excluding upper age restriction. RESULTS Regardless of treatment allocation, 90-day mortality was lower among RCT patients aged ≤80 versus >80 years who otherwise met existing European regulatory criteria (246/2405 [10.2%] versus 307/1028 [29.9%], respectively). Among patients aged >80 years, alteplase versus placebo was associated with a higher proportion of good stroke outcome (modified Rankin Scale score 0-1; 99/518 [19.1%] versus 67/510 [13.1%]; P =0.0109) and similar 90-day mortality (153/518 [29.5%] versus 154/510 [30.2%]; P =0.8382). The odds of a good stroke outcome following alteplase allocation in the full RCT population were independent of age ( P =0.7383). Good stroke outcome was reported for almost half (4821/11 169 [43.2%]) of the patients who received alteplase in routine practice. Outcomes in routine practice supported those achieved in RCTs. CONCLUSIONS Alteplase for AIS has a positive benefit-risk profile among patients aged >80 years when administered according to other regulatory criteria. Alteplase for AIS should be evaluated on an individual benefit-risk basis.",2020,"Among patients aged >80 years, alteplase versus placebo was associated with a higher proportion of good stroke outcome (modified Rankin Scale score 0-1; 99/518 [19.1%] versus 67/510 [13.1%]; P =0.0109) and similar 90-day mortality (153/518 [29.5%] versus 154/510 [30.2%]; P =0.8382).","['Individual patient data', 'patients aged >80 years', 'patients aged 18 to 80 years', 'Patients Aged']","['Alteplase', 'alteplase', 'placebo']","['good functional outcome', 'good stroke outcome (modified Rankin Scale score', '90-day mortality', 'Good stroke outcome']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0032143', 'cui_str': 'alteplase'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}]",,0.126515,"Among patients aged >80 years, alteplase versus placebo was associated with a higher proportion of good stroke outcome (modified Rankin Scale score 0-1; 99/518 [19.1%] versus 67/510 [13.1%]; P =0.0109) and similar 90-day mortality (153/518 [29.5%] versus 154/510 [30.2%]; P =0.8382).","[{'ForeName': 'Erich', 'Initials': 'E', 'LastName': 'Bluhmki', 'Affiliation': 'ADB Building, Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach, Germany and Hochschule Biberach, University of Applied Sciences, Germany (E.B.).'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Danays', 'Affiliation': 'The Medical Department, Boehringer Ingelheim France SAS, Reims (T.D.).'}, {'ForeName': 'Gabriele', 'Initials': 'G', 'LastName': 'Biegert', 'Affiliation': 'The Biostatistics and Data Sciences Corp, Boehringer Ingelheim Pharma GmbH & Co KG, Biberach, Germany (G.B.).'}, {'ForeName': 'Werner', 'Initials': 'W', 'LastName': 'Hacke', 'Affiliation': 'The Department of Neurology, University of Heidelberg, Germany (W.H.).'}, {'ForeName': 'Kennedy R', 'Initials': 'KR', 'LastName': 'Lees', 'Affiliation': 'The School of Medicine, Dentistry & Nursing, University of Glasgow, United Kingdom (K.R.L.).'}]",Stroke,['10.1161/STROKEAHA.119.028396'] 2808,32398324,"Combination of PARP Inhibitor Olaparib, and PD-L1 Inhibitor Durvalumab, in Recurrent Ovarian Cancer: a Proof-of-Concept Phase II Study.","PURPOSE Preclinical studies suggest PARP inhibition (PARPi) induces immunostimulatory micromilieu in ovarian cancer thus complementing activity of immune checkpoint blockade. We conducted a phase II trial of PARPi olaparib and anti-PD-L1 durvalumab and collected paired fresh core biopsies and blood samples to test this hypothesis. PATIENTS AND METHODS In a single-center, proof-of-concept phase II study, we enrolled women aged ≥18 with recurrent ovarian cancer. All patients were immune checkpoint inhibitor-naïve and had measurable disease per RECISTv1.1, ECOG performance status 0-2, and adequate organ and marrow function. Patients received olaparib 300 mg twice daily and durvalumab 1,500 mg intravenously every 4 weeks until disease progression, unacceptable toxicity, or withdrawal of consent. Primary endpoint was overall response rate (ORR). Secondary objectives were safety and progression-free survival (PFS). Translational objectives included biomarker evaluation for relationships with clinical response and immunomodulatory effects by treatment. RESULTS Thirty-five patients with ovarian cancer [median, four prior therapies (IQR, 2-5.5), predominantly platinum-resistant (86%), BRCA wild-type (77%)] received at least one full cycle of treatment. ORR was 14% [5/35; 95% confidence interval (CI), 4.8%-30.3%]. Disease control rate (PR+SD) was 71% (25/35; 95% CI, 53.7%-85.4%). Treatment enhanced IFNγ and CXCL9/CXCL10 expression, systemic IFNγ/TNFα production, and tumor-infiltrating lymphocytes, indicating an immunostimulatory environment. Increased IFNγ production was associated with improved PFS [HR, 0.37 (95% CI, 0.16-0.87), P = 0.023], while elevated VEGFR3 levels were associated with worse PFS (HR, 3.22 (95% CI, 1.23-8.40), P = 0.017]. CONCLUSIONS The PARPi and anti-PD-L1 combination showed modest clinical activity in recurrent ovarian cancer. Our correlative study results suggest immunomodulatory effects by olaparib/durvalumab in patients and indicate that VEGF/VEGFR pathway blockade would be necessary for improved efficacy of the combination.",2020,"Increased IFNγ production was associated with improved PFS [HR, 0.37 (95% CI, 0.16-0.87), P = 0.023], while elevated VEGFR3 levels were associated with worse PFS (HR, 3.22 (95% CI, 1.23-8.40), P = 0.017]. ","['recurrent ovarian cancer', 'enrolled women aged ≥18 with recurrent ovarian cancer', 'Thirty-five patients with ovarian cancer [median, four prior therapies (IQR, 2-5.5), predominantly platinum-resistant (86%), BRCA wild-type (77', 'Recurrent Ovarian Cancer']","['olaparib 300 mg twice daily and durvalumab', 'PARPi olaparib and anti-PD-L1 durvalumab and collected paired fresh core biopsies', 'PARP Inhibitor Olaparib, and PD-L1 Inhibitor Durvalumab', 'PARP inhibition (PARPi']","['IFNγ and CXCL9/CXCL10 expression, systemic IFNγ/TNFα production, and tumor-infiltrating lymphocytes', 'Disease control rate (PR+SD', 'overall response rate (ORR', 'safety and progression-free survival (PFS', 'ORR', 'elevated VEGFR3 levels', 'Increased IFNγ production']","[{'cui': 'C0278689', 'cui_str': 'Recurrent ovarian cancer'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4319605', 'cui_str': '35'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0919267', 'cui_str': 'Neoplasm of ovary'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C3844008', 'cui_str': '5.5'}, {'cui': 'C0032207', 'cui_str': 'Platinum'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0445392', 'cui_str': 'Wild'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C2316164', 'cui_str': 'olaparib'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C4055109', 'cui_str': 'durvalumab'}, {'cui': 'C1567710', 'cui_str': 'PARP1 protein, human'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0965245', 'cui_str': 'CD274 protein, human'}, {'cui': 'C0443224', 'cui_str': 'Fresh'}, {'cui': 'C1318309', 'cui_str': 'Core needle biopsy'}, {'cui': 'C1882413', 'cui_str': 'Nicotinamide adenine dinucleotide adenosine diphosphate ribosyltransferase inhibitor-containing product'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0015457', 'cui_str': 'Facial expression'}, {'cui': 'C0205373', 'cui_str': 'Systemic'}, {'cui': 'C0079722', 'cui_str': 'Tumor-Infiltrating Lymphocytes'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C3657407', 'cui_str': 'vegfr3 protein, human'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205217', 'cui_str': 'Increased'}]",35.0,0.174604,"Increased IFNγ production was associated with improved PFS [HR, 0.37 (95% CI, 0.16-0.87), P = 0.023], while elevated VEGFR3 levels were associated with worse PFS (HR, 3.22 (95% CI, 1.23-8.40), P = 0.017]. ","[{'ForeName': 'Erika J', 'Initials': 'EJ', 'LastName': 'Lampert', 'Affiliation': ""Women's Malignancies Branch, Center for Cancer Research, National Cancer Institute, Bethesda, Maryland.""}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Zimmer', 'Affiliation': ""Women's Malignancies Branch, Center for Cancer Research, National Cancer Institute, Bethesda, Maryland.""}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Padget', 'Affiliation': 'Laboratory of Tumor Immunology and Biology, Center for Cancer Research, National Cancer Institute, Bethesda, Maryland.'}, {'ForeName': 'Ashley', 'Initials': 'A', 'LastName': 'Cimino-Mathews', 'Affiliation': 'Department of Pathology, The Johns Hopkins Medical Institution, Baltimore, Maryland.'}, {'ForeName': 'Jayakumar R', 'Initials': 'JR', 'LastName': 'Nair', 'Affiliation': ""Women's Malignancies Branch, Center for Cancer Research, National Cancer Institute, Bethesda, Maryland.""}, {'ForeName': 'Yingmiao', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Department of Medicine, Duke University Medical Center, Durham, North Carolina.'}, {'ForeName': 'Elizabeth M', 'Initials': 'EM', 'LastName': 'Swisher', 'Affiliation': 'Division of Gynecologic Oncology, Departments of Obstetrics and Gynecology, University of Washington, Seattle, Washington.'}, {'ForeName': 'James W', 'Initials': 'JW', 'LastName': 'Hodge', 'Affiliation': 'Laboratory of Tumor Immunology and Biology, Center for Cancer Research, National Cancer Institute, Bethesda, Maryland.'}, {'ForeName': 'Andrew B', 'Initials': 'AB', 'LastName': 'Nixon', 'Affiliation': 'Department of Medicine, Duke University Medical Center, Durham, North Carolina.'}, {'ForeName': 'Erin', 'Initials': 'E', 'LastName': 'Nichols', 'Affiliation': 'Clinical Research Directorate, Frederick National Laboratory for Cancer Research sponsored by the National Cancer Institute, Bethesda, Maryland.'}, {'ForeName': 'Mohammad H', 'Initials': 'MH', 'LastName': 'Bagheri', 'Affiliation': 'Department of Radiology and Imaging Sciences, Clinical Center, National Cancer Institute, Bethesda, Maryland.'}, {'ForeName': 'Elliott', 'Initials': 'E', 'LastName': 'Levy', 'Affiliation': 'Interventional Radiology, NIH Clinical Center, Bethesda, Maryland.'}, {'ForeName': 'Marc R', 'Initials': 'MR', 'LastName': 'Radke', 'Affiliation': 'Division of Gynecologic Oncology, Departments of Obstetrics and Gynecology, University of Washington, Seattle, Washington.'}, {'ForeName': 'Stanley', 'Initials': 'S', 'LastName': 'Lipkowitz', 'Affiliation': ""Women's Malignancies Branch, Center for Cancer Research, National Cancer Institute, Bethesda, Maryland.""}, {'ForeName': 'Christina M', 'Initials': 'CM', 'LastName': 'Annunziata', 'Affiliation': ""Women's Malignancies Branch, Center for Cancer Research, National Cancer Institute, Bethesda, Maryland.""}, {'ForeName': 'Janis M', 'Initials': 'JM', 'LastName': 'Taube', 'Affiliation': 'Department of Dermatopathology, The Johns Hopkins Medical Institution, Baltimore, Maryland.'}, {'ForeName': 'Seth M', 'Initials': 'SM', 'LastName': 'Steinberg', 'Affiliation': 'Biostatistics and Data Management Section, Center for Cancer Research, National Cancer Institute, Bethesda, Maryland.'}, {'ForeName': 'Jung-Min', 'Initials': 'JM', 'LastName': 'Lee', 'Affiliation': ""Women's Malignancies Branch, Center for Cancer Research, National Cancer Institute, Bethesda, Maryland. leej6@mail.nih.gov.""}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-20-0056'] 2809,32543677,Effect of Physician Notification Regarding Nonadherence to Colorectal Cancer Screening on Early Cancer Detection.,,2020,,[],['Physician Notification'],[],[],"[{'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0422202', 'cui_str': 'Notifications'}]",[],,0.0187088,,"[{'ForeName': 'Héloïse', 'Initials': 'H', 'LastName': 'Schmeltz', 'Affiliation': 'Department of General Practice, Faculty of Medicine of Nantes, Nantes, France.'}, {'ForeName': 'Cédric', 'Initials': 'C', 'LastName': 'Rat', 'Affiliation': 'Department of General Practice, Faculty of Medicine of Nantes, Nantes, France.'}, {'ForeName': 'Corinne', 'Initials': 'C', 'LastName': 'Pogu', 'Affiliation': 'Regional Association in Charge of Colorectal Cancer Screening Program, Nantes, France.'}, {'ForeName': 'Gaëlle', 'Initials': 'G', 'LastName': 'Bianco', 'Affiliation': 'Regional Association in Charge of Colorectal Cancer Screening Program, La Roche sur Yon, France.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Cowppli-Bony', 'Affiliation': 'Cancer Registry for Loire-Atlantique and Vendée Geographic Areas, Nantes, France.'}, {'ForeName': 'Aurélie', 'Initials': 'A', 'LastName': 'Gaultier', 'Affiliation': 'Department of Epidemiology and Biostatistics, Nantes University Hospital, Nantes Cedex 1, France.'}, {'ForeName': 'Jean-Michel', 'Initials': 'JM', 'LastName': 'Nguyen', 'Affiliation': 'Department of Epidemiology and Biostatistics, Nantes University Hospital, Nantes Cedex 1, France.'}]",JAMA,['10.1001/jama.2020.4404'] 2810,31769875,Epidermal growth factor receptor mutation analysis in tissue and plasma from the AURA3 trial: Osimertinib versus platinum-pemetrexed for T790M mutation-positive advanced non-small cell lung cancer.,"BACKGROUND This study assesses different technologies for detecting epidermal growth factor receptor (EGFR) mutations from circulating tumor DNA in patients with EGFR T790M-positive advanced non-small cell lung cancer (NSCLC) from the AURA3 study (NCT02151981), and it evaluates clinical responses to osimertinib and platinum-pemetrexed according to the plasma T790M status. METHODS Tumor tissue biopsy samples were tested for T790M during screening with the cobas EGFR Mutation Test (cobas tissue). Plasma samples were collected at screening and at the baseline and were retrospectively analyzed for EGFR mutations with the cobas EGFR Mutation Test v2 (cobas plasma), droplet digital polymerase chain reaction (ddPCR; Biodesix), and next-generation sequencing (NGS; Guardant360, Guardant Health). RESULTS With cobas tissue test results as a reference, the plasma T790M positive percent agreement (PPA) was 51% (110 of 215 samples) by cobas plasma, 58% (110 of 189) by ddPCR, and 66% (136 of 207) by NGS. Plasma T790M detection was associated with a larger median baseline tumor size (56 mm for T790M-positive vs 39 mm for T790M-negative; P < .0001) and the presence of extrathoracic disease (58% for M1b-positive vs 39% for M0-1a-positive; P = .002). Progression-free survival (PFS) was prolonged in randomized patients (tissue T790M-positive) with a T790M-negative cobas plasma result in comparison with those with a T790M-positive plasma result in both osimertinib (median, 12.5 vs 8.3 months) and platinum-pemetrexed groups (median, 5.6 vs 4.2 months). CONCLUSIONS PPA was similar between ddPCR and NGS assays; both were more sensitive than cobas plasma. All 3 test platforms are suitable for routine clinical practice. In patients with tissue T790M-positive NSCLC, an absence of detectable plasma T790M at the baseline is associated with longer PFS, which may be attributed to a lower disease burden.",2020,Plasma T790M detection was associated with a larger median baseline tumor size (56 mm for T790M-positive vs 39 mm for T790M-negative; P < .0001) and the presence of extrathoracic disease (58% for M1b-positive vs 39% for M0-1a-positive; P = .002).,"['Tumor tissue biopsy samples were tested for T790M during screening with the cobas EGFR Mutation Test (cobas tissue', 'T790M mutation-positive advanced non-small cell lung cancer', 'patients with EGFR T790M-positive advanced non-small cell lung cancer (NSCLC']",['Osimertinib versus platinum-pemetrexed'],"['Plasma T790M detection', 'Progression-free survival (PFS', 'plasma T790M positive percent agreement (PPA', 'presence of extrathoracic disease']","[{'cui': 'C0475358', 'cui_str': 'Tumor tissue sample'}, {'cui': 'C0677862', 'cui_str': 'Biopsy sample'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0034802', 'cui_str': 'Epidermal growth factor-urogastrone receptor'}, {'cui': 'C0026882', 'cui_str': 'Genetic mutation'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0007131', 'cui_str': 'Non-small cell lung cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C4058811', 'cui_str': 'osimertinib'}, {'cui': 'C0032207', 'cui_str': 'Platinum'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]",,0.149376,Plasma T790M detection was associated with a larger median baseline tumor size (56 mm for T790M-positive vs 39 mm for T790M-negative; P < .0001) and the presence of extrathoracic disease (58% for M1b-positive vs 39% for M0-1a-positive; P = .002).,"[{'ForeName': 'Vassiliki A', 'Initials': 'VA', 'LastName': 'Papadimitrakopoulou', 'Affiliation': 'The University of Texas MD Anderson Cancer Center, Houston, Texas.'}, {'ForeName': 'Ji-Youn', 'Initials': 'JY', 'LastName': 'Han', 'Affiliation': 'Center for Lung Cancer, National Cancer Center, Goyang, Republic of Korea.'}, {'ForeName': 'Myung-Ju', 'Initials': 'MJ', 'LastName': 'Ahn', 'Affiliation': 'Samsung Medical Center, School of Medicine, Sungkyunkwan University, Seoul, Republic of Korea.'}, {'ForeName': 'Suresh S', 'Initials': 'SS', 'LastName': 'Ramalingam', 'Affiliation': 'Winship Cancer Institute, Emory University, Atlanta, Georgia.'}, {'ForeName': 'Angelo', 'Initials': 'A', 'LastName': 'Delmonte', 'Affiliation': 'Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola, Italy.'}, {'ForeName': 'Te-Chun', 'Initials': 'TC', 'LastName': 'Hsia', 'Affiliation': 'China Medical University, Taichung City, Taiwan.'}, {'ForeName': 'Janessa', 'Initials': 'J', 'LastName': 'Laskin', 'Affiliation': 'British Columbia Cancer Agency, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Sang-We', 'Initials': 'SW', 'LastName': 'Kim', 'Affiliation': 'Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'He', 'Affiliation': 'Daping Hospital, Third Military Medical University, Chongqing, China.'}, {'ForeName': 'Chun-Ming', 'Initials': 'CM', 'LastName': 'Tsai', 'Affiliation': 'Taipei Veterans General Hospital, Taipei, Taiwan.'}, {'ForeName': 'Toyoaki', 'Initials': 'T', 'LastName': 'Hida', 'Affiliation': 'Aichi Cancer Center, Nagoya, Japan.'}, {'ForeName': 'Makoto', 'Initials': 'M', 'LastName': 'Maemondo', 'Affiliation': 'Iwate Medical University School of Medicine, Iwate, Japan.'}, {'ForeName': 'Terufumi', 'Initials': 'T', 'LastName': 'Kato', 'Affiliation': 'Kanagawa Cancer Center, Yokohama, Japan.'}, {'ForeName': 'Suzanne', 'Initials': 'S', 'LastName': 'Jenkins', 'Affiliation': 'Precision Medicine, R&D Oncology, AstraZeneca, Cambridge, United Kingdom.'}, {'ForeName': 'Sabina', 'Initials': 'S', 'LastName': 'Patel', 'Affiliation': 'Precision Medicine, R&D Oncology, AstraZeneca, Cambridge, United Kingdom.'}, {'ForeName': 'Xiangning', 'Initials': 'X', 'LastName': 'Huang', 'Affiliation': 'Precision Medicine, R&D Oncology, AstraZeneca, Cambridge, United Kingdom.'}, {'ForeName': 'Gianluca', 'Initials': 'G', 'LastName': 'Laus', 'Affiliation': 'Global Medicines Development, AstraZeneca, Cambridge, United Kingdom.'}, {'ForeName': 'Aleksandra', 'Initials': 'A', 'LastName': 'Markovets', 'Affiliation': 'Translational Medicine, Oncology, AstraZeneca, Boston, Massachusetts.'}, {'ForeName': 'Kenneth S', 'Initials': 'KS', 'LastName': 'Thress', 'Affiliation': 'Oncology Translational Sciences, Innovative Medicines and Early Development Biotech Unit, AstraZeneca, Waltham, Massachusetts.'}, {'ForeName': 'Yi-Long', 'Initials': 'YL', 'LastName': 'Wu', 'Affiliation': 'Guangdong General Hospital, Guangdong Academy of Medical Sciences, Guangzhou, China.'}, {'ForeName': 'Tony', 'Initials': 'T', 'LastName': 'Mok', 'Affiliation': 'State Key Laboratory of South China, Department of Clinical Oncology, Chinese University of Hong Kong, Hong Kong, China.'}]",Cancer,['10.1002/cncr.32503'] 2811,30723316,Predicting antidepressant treatment outcome based on socioeconomic status and citalopram dose.,"Selective serotonin reuptake inhibitors (SSRIs), the most prescribed antidepressant drugs, have incomplete efficacy and no clear mechanism of action. In addition, no reliable methods to identify patients who will benefit from treatment is available. In this study, we show that citalopram, a commonly used SSRI, produces a dose-dependent amplification of the influence of the environment on mood, making the severity of symptoms dependent on the level of socioeconomic status (SES). As a consequence, based on SES, we were able to predict which patients would show remission following 12 weeks of treatment in the high, but not the low dose group. Our findings support a novel mechanism of action for SSRIs, which calls for a permissive rather than an instructive role of these drugs, and indicate that treatment outcome can be predicted based on SES and dose. Finally, our findings suggest that the patient's social and economic conditions should be considered in setting up personalized strategies aimed at enhancing SSRI efficacy.",2019,"As a consequence, based on SES, we were able to predict which patients would show remission following 12 weeks of treatment in the high, but not the low dose group.",[],"['Selective serotonin reuptake inhibitors (SSRIs', 'citalopram']",[],[],"[{'cui': 'C0360105', 'cui_str': 'Selective serotonin re-uptake inhibitor'}, {'cui': 'C0008845', 'cui_str': 'Citalopram'}]",[],,0.0159344,"As a consequence, based on SES, we were able to predict which patients would show remission following 12 weeks of treatment in the high, but not the low dose group.","[{'ForeName': 'Aurelia', 'Initials': 'A', 'LastName': 'Viglione', 'Affiliation': 'Center for Behavioral Sciences and Mental Health, Istituto Superiore di Sanità, Rome, Italy.'}, {'ForeName': 'Flavia', 'Initials': 'F', 'LastName': 'Chiarotti', 'Affiliation': 'Center for Behavioral Sciences and Mental Health, Istituto Superiore di Sanità, Rome, Italy.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Poggini', 'Affiliation': 'Center for Behavioral Sciences and Mental Health, Istituto Superiore di Sanità, Rome, Italy.'}, {'ForeName': 'Alessandro', 'Initials': 'A', 'LastName': 'Giuliani', 'Affiliation': 'Department of Environment and Health, Istituto Superiore di Sanità, Rome, Italy.'}, {'ForeName': 'Igor', 'Initials': 'I', 'LastName': 'Branchi', 'Affiliation': 'Center for Behavioral Sciences and Mental Health, Istituto Superiore di Sanità, Rome, Italy. igor.branchi@iss.it.'}]",The pharmacogenomics journal,['10.1038/s41397-019-0080-6'] 2812,32618267,"Adherence to Mass Drug Administration with Dihydroartemisinin-Piperaquine and Plasmodium falciparum Clearance in Southern Province, Zambia.","Mass drug administration (MDA) with artemisinin combination therapy is a potentially useful tool for malaria elimination programs, but its success depends partly on drug effectiveness and treatment coverage in the targeted population. As part of a cluster-randomized controlled trial in Southern Province, Zambia evaluating the impact of MDA and household focal MDA (fMDA) with dihydroartemisinin-piperaquine (DHAp), sub-studies were conducted investigating population drug adherence rates and effectiveness of DHAp as administered in clearing Plasmodium falciparum infections following household mass administration. Adherence information was reported for 181,534 of 336,821 DHAp (53.9%) treatments administered during four rounds of MDA/fMDA, of which 153,197 (84.4%) reported completing the full course of DHAp. The proportion of participants fully adhering to the treatment regimen differed by MDA modality (MDA versus fMDA), RDT status, and whether the first dose was observed by those administering treatments. Among a subset of participants receiving DHAp and selected for longitudinal follow-up, 58 were positive for asexual-stage P. falciparum infection by microscopy at baseline. None of the 45 participants followed up at days 3 and/or 7 were slide positive for asexual-stage parasitemia. For those with longer term follow-up, one participant was positive 47 days after treatment, and two additional participants were positive after 69 days, although these two were determined to be new infections by genotyping. High completion of a 3-day course of DHAp and parasite clearance in the context of household MDA are promising as Zambia's National Malaria Programme continues to weigh appropriate interventions for malaria elimination.",2020,None of the 45 participants followed up at days 3 and/or 7 were slide positive for asexual-stage parasitemia.,"['Southern Province, Zambia evaluating the impact of MDA and household focal MDA (fMDA) with', 'Southern Province, Zambia']","['Dihydroartemisinin-Piperaquine', 'DHAp', 'artemisinin combination therapy', 'dihydroartemisinin-piperaquine (DHAp']","['Adherence information', 'MDA modality (MDA versus fMDA), RDT status', 'slide positive for asexual-stage parasitemia']","[{'cui': 'C0043445', 'cui_str': 'Zambia'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C4505223', 'cui_str': 'Mass Administration'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0205234', 'cui_str': 'Focal'}, {'cui': 'C0000379', 'cui_str': 'Methylenedioxyamphetamine'}]","[{'cui': 'C0058108', 'cui_str': 'dihydroartemisinin'}, {'cui': 'C0071105', 'cui_str': 'piperaquine'}, {'cui': 'C0052430', 'cui_str': 'artemisinin'}, {'cui': 'C0009429', 'cui_str': 'Combination therapy'}]","[{'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C4505223', 'cui_str': 'Mass Administration'}, {'cui': 'C0205234', 'cui_str': 'Focal'}, {'cui': 'C0000379', 'cui_str': 'Methylenedioxyamphetamine'}, {'cui': 'C0206743', 'cui_str': 'Malignant rhabdoid tumor'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0332246', 'cui_str': 'Sliding'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0242723', 'cui_str': 'Parasitemia'}]",,0.179382,None of the 45 participants followed up at days 3 and/or 7 were slide positive for asexual-stage parasitemia.,"[{'ForeName': 'Timothy P', 'Initials': 'TP', 'LastName': 'Finn', 'Affiliation': 'Department of Tropical Medicine, Center for Applied Malaria Research and Evaluation, Tulane University School of Public Health and Tropical Medicine, New Orleans, Louisiana.'}, {'ForeName': 'Travis R', 'Initials': 'TR', 'LastName': 'Porter', 'Affiliation': 'Department of Tropical Medicine, Center for Applied Malaria Research and Evaluation, Tulane University School of Public Health and Tropical Medicine, New Orleans, Louisiana.'}, {'ForeName': 'Hawela', 'Initials': 'H', 'LastName': 'Moonga', 'Affiliation': 'National Malaria Elimination Centre, Zambia Ministry of Health, Chainama Hospital Grounds, Lusaka, Zambia.'}, {'ForeName': 'Kafula', 'Initials': 'K', 'LastName': 'Silumbe', 'Affiliation': 'PATH Malaria Control and Elimination Partnership in Africa (MACEPA), Lusaka, Zambia.'}, {'ForeName': 'Rachel F', 'Initials': 'RF', 'LastName': 'Daniels', 'Affiliation': 'The Broad Institute of MIT and Harvard, Cambridge, Massachusetts.'}, {'ForeName': 'Sarah K', 'Initials': 'SK', 'LastName': 'Volkman', 'Affiliation': 'Simmons University, Boston, Massachusetts.'}, {'ForeName': 'Joshua O', 'Initials': 'JO', 'LastName': 'Yukich', 'Affiliation': 'Department of Tropical Medicine, Center for Applied Malaria Research and Evaluation, Tulane University School of Public Health and Tropical Medicine, New Orleans, Louisiana.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Keating', 'Affiliation': 'Department of Tropical Medicine, Center for Applied Malaria Research and Evaluation, Tulane University School of Public Health and Tropical Medicine, New Orleans, Louisiana.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Bennett', 'Affiliation': 'Malaria Elimination Initiative, Global Health Group, University of California San Francisco, San Francisco, California.'}, {'ForeName': 'Richard W', 'Initials': 'RW', 'LastName': 'Steketee', 'Affiliation': 'PATH MACEPA, Seattle, Washington.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Miller', 'Affiliation': 'PATH Malaria Control and Elimination Partnership in Africa (MACEPA), Lusaka, Zambia.'}, {'ForeName': 'Thomas P', 'Initials': 'TP', 'LastName': 'Eisele', 'Affiliation': 'Department of Tropical Medicine, Center for Applied Malaria Research and Evaluation, Tulane University School of Public Health and Tropical Medicine, New Orleans, Louisiana.'}]",The American journal of tropical medicine and hygiene,['10.4269/ajtmh.19-0667'] 2813,32618279,"Safety and immunogenicity of a Zika purified inactivated virus vaccine given via standard, accelerated, or shortened schedules: a single-centre, double-blind, sequential-group, randomised, placebo-controlled, phase 1 trial.","BACKGROUND The development of an effective vaccine against Zika virus remains a public health priority. A Zika purified inactivated virus (ZPIV) vaccine candidate has been shown to protect animals against Zika virus challenge and to be well tolerated and immunogenic in humans up to 8 weeks of follow-up. We aimed to assess the safety and immunogenicity of ZPIV in humans up to 52 weeks of follow-up when given via standard or accelerated vaccination schedules. METHODS We did a single-centre, double-blind, randomised controlled, phase 1 trial in healthy adults aged 18-50 years with no known history of flavivirus vaccination or infection at Beth Israel Deaconess Medical Center in Boston, MA, USA. Participants were sequentially enrolled into one of three groups: ZPIV given at weeks 0 and 4 (standard regimen), weeks 0 and 2 (accelerated regimen), or week 0 alone (single-dose regimen). Within each group, participants were randomly assigned using a computer-generated randomisation schedule to receive an intramuscular injection of 5 μg ZPIV or saline placebo, in a ratio of 5:1. The sponsor, clinical staff, investigators, participants, and laboratory personnel were masked to treatment assignment. The primary endpoint was safety up to day 364 after final dose administration, and secondary endpoints were proportion of participants with positive humoral immune responses (50% microneutralisation titre [MN 50 ] ≥100) and geometric mean MN 50 at observed peak response (ie, the highest neutralising antibody level observed for an individual participant across all timepoints) and week 28. All participants who received at least one dose of ZPIV or placebo were included in the safety population; the analysis of immunogenicity at observed peak included all participants who received at least one dose of ZPIV or placebo and had any adverse events or immunogenicity data after dosing. The week 28 immunogenicity analysis population consisted of all participants who received ZPIV or placebo and had immunogenicity data available at week 28. This trial is registered with ClinicalTrials.gov, NCT02937233. FINDINGS Between Dec 8, 2016, and May 17, 2017, 12 participants were enrolled into each group and then randomly assigned to vaccine (n=10) or placebo (n=2). There were no serious or grade 3 treatment-related adverse events. The most common reactions among the 30 participants who received the vaccine were injection-site pain (24 [80%]), fatigue (16 [53%]), and headache (14 [46%]). A positive response at observed peak titre was detected in all participants who received ZPIV via the standard regimen, in eight (80%) of ten participants who received ZPIV via the accelerated regimen, and in none of the ten participants who received ZPIV via the single-dose regimen. The geometric mean of all individual participants' observed peak values was 1153·9 (95% CI 455·2-2925·2) in the standard regimen group, 517·7 (142·9-1875·6) in the accelerated regimen group, and 6·3 (3·7-10·8) in the single-dose regimen group. At week 28, a positive response was observed in one (13%) of eight participants who received ZPIV via the standard regimen and in no participant who received ZPIV via the accelerated (n=7) or single-dose (n=10) regimens. The geomteric mean titre (GMT) at this timepoint was 13·9 (95% CI 3·5-55·1) in the standard regimen group and 6·9 (4·0-11·9) in the accelerated regimen group; antibody titres were undetectable at 28 weeks in participants who received ZPIV via the single-dose regimen. For all vaccine schedules, GMTs peaked 2 weeks after the final vaccination and declined to less than 100 by study week 16. There was no difference in observed peak GMTs between the standard 4-week and the accelerated 2-week boosting regimens (p=0·4494). INTERPRETATION ZPIV was safe and well tolerated in humans up to 52 weeks of follow-up. ZPIV immunogenicity required two doses and was not durable. Additional studies of ZPIV to optimise dosing schedules are ongoing. FUNDING The Henry M Jackson Foundation for the Advancement of Military Medicine.",2020,"There was no difference in observed peak GMTs between the standard 4-week and the accelerated 2-week boosting regimens (p=0·4494). ","['healthy adults aged 18-50 years with no known history of flavivirus vaccination or infection at Beth Israel Deaconess Medical Center in Boston, MA, USA']","['intramuscular injection of 5 μg ZPIV or saline placebo', 'ZPIV or placebo', 'Zika purified inactivated virus vaccine', 'vaccine', 'ZPIV', 'placebo']","['headache', 'Safety and immunogenicity', 'fatigue', 'ZPIV immunogenicity', 'geomteric mean titre (GMT', 'injection-site pain', 'adverse events or immunogenicity data', 'safety and immunogenicity', 'proportion of participants with positive humoral immune responses', 'serious or grade 3 treatment-related adverse events', ' antibody titres', 'geometric mean MN 50 at observed peak response (ie, the highest neutralising antibody level', 'positive response', 'peak titre', 'observed peak GMTs']","[{'cui': 'C0686750', 'cui_str': 'Well adult'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205309', 'cui_str': 'Known'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0016215', 'cui_str': 'Flavivirus'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0022271', 'cui_str': 'Israel'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0006037', 'cui_str': 'Boston'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}]","[{'cui': 'C0021492', 'cui_str': 'Intramuscular injection'}, {'cui': 'C0276289', 'cui_str': 'Zika virus disease'}, {'cui': 'C0042769', 'cui_str': 'Viral disease'}, {'cui': 'C0036082', 'cui_str': 'Sodium chloride solution'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}]","[{'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0276289', 'cui_str': 'Zika virus disease'}, {'cui': 'C0042769', 'cui_str': 'Viral disease'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0475208', 'cui_str': 'Titer'}, {'cui': 'C0151828', 'cui_str': 'Injection site pain'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0020967', 'cui_str': 'Humoral Immunity'}, {'cui': 'C0475271', 'cui_str': 'G3 grade'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0003241', 'cui_str': 'Antibody'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0475463', 'cui_str': 'Neutralizing antibody'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",12.0,0.542669,"There was no difference in observed peak GMTs between the standard 4-week and the accelerated 2-week boosting regimens (p=0·4494). ","[{'ForeName': 'Kathryn E', 'Initials': 'KE', 'LastName': 'Stephenson', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA; Ragon Institute of Massachusetts General Hospital, Massachusetts Institute of Technology and Harvard, Cambridge, MA, USA.'}, {'ForeName': 'Chen Sabrina', 'Initials': 'CS', 'LastName': 'Tan', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Stephen R', 'Initials': 'SR', 'LastName': 'Walsh', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Hale', 'Affiliation': 'University of Vermont Medical Center, Burlington, VT, USA; Larner College of Medicine, Burlington, VT, USA.'}, {'ForeName': 'Jessica L', 'Initials': 'JL', 'LastName': 'Ansel', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Diane G', 'Initials': 'DG', 'LastName': 'Kanjilal', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Jaegle', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Peter', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Erica N', 'Initials': 'EN', 'LastName': 'Borducchi', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Joseph P', 'Initials': 'JP', 'LastName': 'Nkolola', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Tatenda', 'Initials': 'T', 'LastName': 'Makoni', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Fogel', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Connor', 'Initials': 'C', 'LastName': 'Bradshaw', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Tyler', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Moseley', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Abishek', 'Initials': 'A', 'LastName': 'Chandrashekar', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Katherine E', 'Initials': 'KE', 'LastName': 'Yanosick', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Seaman', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA.'}, {'ForeName': 'Kenneth H', 'Initials': 'KH', 'LastName': 'Eckels', 'Affiliation': 'Walter Reed Army Institute of Research, Silver Spring, MD, USA.'}, {'ForeName': 'Rafael A', 'Initials': 'RA', 'LastName': 'De La Barrera', 'Affiliation': 'Walter Reed Army Institute of Research, Silver Spring, MD, USA.'}, {'ForeName': 'Jason', 'Initials': 'J', 'LastName': 'Thompson', 'Affiliation': 'Emmes, Rockville, MD, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Dawson', 'Affiliation': 'Emmes, Rockville, MD, USA.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Thomas', 'Affiliation': 'Walter Reed Army Institute of Research, Silver Spring, MD, USA.'}, {'ForeName': 'Nelson L', 'Initials': 'NL', 'LastName': 'Michael', 'Affiliation': 'Walter Reed Army Institute of Research, Silver Spring, MD, USA.'}, {'ForeName': 'Kayvon', 'Initials': 'K', 'LastName': 'Modjarrad', 'Affiliation': 'Walter Reed Army Institute of Research, Silver Spring, MD, USA.'}, {'ForeName': 'Dan H', 'Initials': 'DH', 'LastName': 'Barouch', 'Affiliation': 'Center for Virology and Vaccine Research, Beth Israel Deaconess Medical Center, Boston, MA, USA; Ragon Institute of Massachusetts General Hospital, Massachusetts Institute of Technology and Harvard, Cambridge, MA, USA. Electronic address: dbarouch@bidmc.harvard.edu.'}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(20)30085-2'] 2814,32618383,Sotagliflozin added to optimised insulin therapy leads to HbA1c reduction without weight gain in adults with type 1 diabetes: a pooled analysis of inTandem1 and inTandem2.,"AIMS Insulin intensification is associated with weight gain, which may negate the benefits of improved glycemic control in adults with type 1 diabetes (T1D). This post hoc analysis evaluated whether the addition of sotagliflozin to optimised insulin significantly increases the proportion of adults with T1D who achieve HbA1c goals without weight gain. MATERIALS AND METHODS In a patient-level pooled analysis (n = 1575) of data from two phase 3, 52-week clinical trials (inTandem1 and inTandem2), the change from baseline in HbA1c and weight as well as the proportion of participants achieving an HbA1c <7% without weight gain were compared between groups treated with placebo, sotagliflozin 200 mg, and sotagliflozin 400 mg. RESULTS From a mean baseline HbA1c of 7.7%, mean HbA1c changes at week 24 were - 0.36% (95% CI -0.44 to -0.29) and - 0.38% (-0.45 to -0.31) with sotagliflozin 200 and 400 mg vs placebo (P = 0.001 for both), respectively, with sustained effects through week 52. Weight significantly decreased at weeks 24 and 52 in both sotagliflozin groups compared with placebo. At week 52, the proportion of patients who achieved a HbA1c <7% without weight gain was 21.8% with sotagliflozin 200 mg, 26.1% with sotagliflozin 400 mg, and 9.1% with placebo (P < 0.001). Other HbA1c, weight, and safety composite variables showed similar significant trends. CONCLUSION When added to optimised insulin therapy, sotagliflozin improved glycaemic control and body weight and enabled more adults with T1D to achieve A1c goals without weight gain over 52 weeks, although there was more DKA relative to placebo. This article is protected by copyright. All rights reserved.",2020,"200 and 400 mg vs placebo (P = 0.001 for both), respectively, with sustained effects through week 52.","['adults with type 1 diabetes', 'adults with T1D who achieve HbA1c goals without weight gain', 'adults with type 1 diabetes (T1D']","['placebo, sotagliflozin 200\u2009mg, and sotagliflozin 400\u2009mg', 'insulin therapy, sotagliflozin', 'Sotagliflozin', 'sotagliflozin', 'placebo']","['mean HbA1c changes', 'Weight', 'weight gain', 'glycaemic control and body weight']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C3502471', 'cui_str': '(2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2H-pyran-3,4,5-triol'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C3816746', 'cui_str': '400'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",,0.29173,"200 and 400 mg vs placebo (P = 0.001 for both), respectively, with sustained effects through week 52.","[{'ForeName': 'Helena W', 'Initials': 'HW', 'LastName': 'Rodbard', 'Affiliation': 'Endocrine and Metabolic Consultants, Rockville, Maryland, USA.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Giaccari', 'Affiliation': 'Fondazione Policlinico Universitario A. Gemelli IRCCS, Università Cattolica del Sacro Cuore, Rome, Italy.'}, {'ForeName': 'Rosemarie', 'Initials': 'R', 'LastName': 'Lajara', 'Affiliation': 'Diabetes Centers of America-Dallas-Fort Worth, Plano, Texas, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Stewart', 'Affiliation': 'Sanofi, Laval, Québec, Canada.'}, {'ForeName': 'Paul S', 'Initials': 'PS', 'LastName': 'Strumph', 'Affiliation': 'Lexicon Pharmaceuticals, Inc., The Woodlands, Texas, USA.'}, {'ForeName': 'Juliana', 'Initials': 'J', 'LastName': 'Oliveira', 'Affiliation': 'Sanofi, Bridgewater, New Jersey, USA.'}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Lapuerta', 'Affiliation': 'Lexicon Pharmaceuticals, Inc., The Woodlands, Texas, USA.'}, {'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Castro', 'Affiliation': 'Sanofi, Bridgewater, New Jersey, USA.'}]","Diabetes, obesity & metabolism",['10.1111/dom.14127'] 2815,32618385,"The effect of referral to an open-group behavioural weight management programme on the relative risk of normoglycaemia, non-diabetic hyperglycaemia and type 2 diabetes: secondary analysis of the WRAP trial.","AIMS We examined the impact of open-group behavioural weight management programmes on diabetes risk among i) those with BMI ≥28 kg/m 2 and ii) those with non-diabetic hyperglycaemia (NDH). METHODS This was a secondary analysis of data from the WRAP trial, in which participants (N = 1267; ≥18 years, BMI ≥28 kg/m 2 ) were randomised to: brief intervention (BI; self-help booklet), a weight management programme (WW, formerly Weight Watchers) for 12-weeks, or WW for 52 weeks. We used multinomial logistic regression to examine the effect of intervention group on the risk of hyperglycaemia and diabetes at 12 months in all participants with glycaemic status at both time points (N = 480; 38%) and those with NDH at baseline (N = 387; 31%). We used mixed effects models and linear fixed effects models to examine the effect of intervention group on body weight and HbA 1c at 12 months in people with NDH. RESULTS There was a 61% relative reduction in risk of NDH at 12 month follow up [12-weeks vs BI: Relative Risk Ratio, RRR = 0.39 (95% CI 0.18, 0.87), p = 0.021; 52-weeks vs BI: RRR = 0.38 (95% CI 0.17, 0.86), p = 0.020]. For intervention effects on risk of diabetes, confidence intervals were wide and overlapped 1 [12-weeks vs BI: RRR = 0.49 (95% CI 0.12, 1.96), p = 0.312; 52-weeks vs BI: RRR = 0.40 (95% CI 0.10, 1.63), p = 0.199]. Participants with hyperglycaemia at baseline in the weight management programme were more likely to have normoglycaemia at 12 month follow up [12-week programme vs BI: RRR = 3.57 (CI 1.24, 10.29), p = 0.019; 52-week programme vs BI: RRR = 4.14 (CI 1.42, 12.12), p = 0.009]. CONCLUSIONS Open group behavioural weight management programmes can help to prevent the development of NDH in people with overweight and obesity and to normalise glycaemia in people with NDH.",2020,There was a 61% relative reduction in risk of NDH at 12 month follow up,"['participants with glycaemic status at both time points (N\xa0=\xa0480; 38%) and those with NDH at baseline', 'people with overweight and obesity and to normalise glycaemia in people with NDH', 'diabetes risk among i', 'participants (N\xa0=\xa01267; ≥18\u2009years, BMI ≥28\u2009kg/m 2 ', 'Participants with hyperglycaemia at baseline in the weight management programme', 'people with NDH']","['open-group behavioural weight management programmes', 'brief intervention (BI; self-help booklet), a weight management programme (WW, formerly Weight Watchers', 'open-group behavioural weight management programme']","['risk of NDH', 'risk of hyperglycaemia and diabetes', 'risk of diabetes, confidence intervals', 'relative risk of normoglycaemia, non-diabetic hyperglycaemia', 'body weight and HbA 1c', 'normoglycaemia']","[{'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C4319609', 'cui_str': '480'}, {'cui': 'C1857775', 'cui_str': 'Diabetes Mellitus, Neonatal, with Congenital Hypothyroidism'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C4273558', 'cui_str': 'Weight management program'}]","[{'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4273558', 'cui_str': 'Weight management program'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}]","[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C1857775', 'cui_str': 'Diabetes Mellitus, Neonatal, with Congenital Hypothyroidism'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0009667', 'cui_str': 'Confidence Intervals'}, {'cui': 'C0242492', 'cui_str': 'Relative Risk'}, {'cui': 'C0850671', 'cui_str': 'Non-diabetic hyperglycemia'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}]",,0.115204,There was a 61% relative reduction in risk of NDH at 12 month follow up,"[{'ForeName': 'Amy L', 'Initials': 'AL', 'LastName': 'Ahern', 'Affiliation': 'MRC Epidemiology Unit, University of Cambridge.'}, {'ForeName': 'Simon J', 'Initials': 'SJ', 'LastName': 'Griffin', 'Affiliation': 'MRC Epidemiology Unit, University of Cambridge.'}, {'ForeName': 'Graham M', 'Initials': 'GM', 'LastName': 'Wheeler', 'Affiliation': 'MRC Epidemiology Unit, University of Cambridge.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Sharp', 'Affiliation': 'MRC Epidemiology Unit, University of Cambridge.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Aveyard', 'Affiliation': 'MRC Epidemiology Unit, University of Cambridge.'}, {'ForeName': 'Emma J', 'Initials': 'EJ', 'LastName': 'Boyland', 'Affiliation': 'MRC Epidemiology Unit, University of Cambridge.'}, {'ForeName': 'Jason Cg', 'Initials': 'JC', 'LastName': 'Halford', 'Affiliation': 'MRC Epidemiology Unit, University of Cambridge.'}, {'ForeName': 'Susan A', 'Initials': 'SA', 'LastName': 'Jebb', 'Affiliation': 'MRC Epidemiology Unit, University of Cambridge.'}]","Diabetes, obesity & metabolism",['10.1111/dom.14123'] 2816,32618538,Influence of pre-schooler and parent nutrition education on carotenoid levels of Mexican-heritage children.,"OBJECTIVE To determine the mediating effect of direct preschool and parent nutrition education on changes in skin carotenoids scores over 2 years in children of Mexican heritage. DESIGN In a quasi-experimental, community-based study, two school districts were randomly assigned to either a comparison group (parent workshops unrelated to nutrition) or a childhood obesity prevention intervention group which included nutrition education at family nights for parents and at school for children. Changes in skin carotenoid intensity scores (diffCAROT, year 2015 minus 2013) were measured in children as a proxy for fruit and vegetable consumption using Resonance Raman Spectroscopy. SETTING Two rural, low-income, school districts from a county in California's Central Valley. PARTICIPANTS 316 Mexican heritage families with children aged 3-8 years. RESULTS Intervention group children improved over 2 years in skin carotenoid scores relative to comparison group children (diffCAROT mean +1419 (sd 9540) v. -3473 (sd 9272), P = 0·0001). Parent attendance at nutrition education classes partially mediated the intervention effect on diffCAROT (P = 0·02). Controlling for child's age and other covariates, participation in preschool during the study had a significant positive effect on diffCAROT among intervention children compared with controls (P < 0·03), whereas no significant difference by group was observed among those not enrolled in preschool or already enrolled in elementary school. CONCLUSIONS Programmes that combine direct parent and preschool nutrition education may be effective in low-income Mexican heritage families to improve children's intake of fruit and vegetables.",2020,"RESULTS Intervention group children improved over 2 years in skin carotenoid scores relative to comparison group children (diffCAROT mean +1419 (sd 9540) v. -3473 (sd 9272), P = 0·0001).","['316 Mexican heritage families with children aged 3-8 years', ""Two rural, low-income, school districts from a county in California's Central Valley"", 'In a quasi-experimental, community-based study, two school districts', 'children of Mexican heritage', 'Mexican-heritage children']","['direct preschool and parent nutrition education', 'pre-schooler and parent nutrition education', 'comparison group (parent workshops unrelated to nutrition) or a childhood obesity prevention intervention group which included nutrition education at family nights for parents and at school for children']","['skin carotenoid scores', 'skin carotenoid intensity scores', 'skin carotenoids scores']","[{'cui': 'C0450356', 'cui_str': '316'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0032854', 'cui_str': 'Financially poor'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0006754', 'cui_str': 'California'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0563004', 'cui_str': 'Valley'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0680063', 'cui_str': 'Child of'}]","[{'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0204932', 'cui_str': 'Diet education'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0242262', 'cui_str': 'Workshops'}, {'cui': 'C0445356', 'cui_str': 'Unrelated'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C2362324', 'cui_str': 'Childhood obesity'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0008059', 'cui_str': 'Child'}]","[{'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C0007271', 'cui_str': 'Carotinoid'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}]",,0.0238306,"RESULTS Intervention group children improved over 2 years in skin carotenoid scores relative to comparison group children (diffCAROT mean +1419 (sd 9540) v. -3473 (sd 9272), P = 0·0001).","[{'ForeName': 'Marcel', 'Initials': 'M', 'LastName': 'Horowitz', 'Affiliation': 'University of California Cooperative Extension, Yolo County, Woodland, CA95695, USA.'}, {'ForeName': 'Lucia L', 'Initials': 'LL', 'LastName': 'Kaiser', 'Affiliation': 'Department of Nutrition, University of California, Davis, CA, USA.'}, {'ForeName': 'Rosa D', 'Initials': 'RD', 'LastName': 'Manzo', 'Affiliation': 'Health Sciences Research Institute, University of California, Merced, CA, USA.'}, {'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Aguilera', 'Affiliation': 'Department of Public Health, University of California, Merced, CA, USA.'}, {'ForeName': 'L Karina', 'Initials': 'LK', 'LastName': 'Diaz Rios', 'Affiliation': 'Division of Agriculture and Natural Resources, University of California, Merced, CA, USA.'}, {'ForeName': 'Karina', 'Initials': 'K', 'LastName': 'Macias', 'Affiliation': 'University of California Cooperative Extension, Fresno County, CA, USA.'}]",Public health nutrition,['10.1017/S1368980019004579'] 2817,32618572,Use of a Mobile App to Augment Psychotherapy in a Community Psychiatric Clinic: Feasibility and Fidelity Trial.,"BACKGROUND Even though 1 in 5 Americans experience some form of mental illness each year, 80% have been shown to discontinue psychotherapy prematurely. The traditional psychotherapy service delivery model, consisting of isolated clinical sessions, lacks the ability to keep patients engaged outside clinical sessions. Newer digital mental health platforms can address the clinical need for a robust tool that tracks mental well-being and improves engagement in patients with depressive symptoms. OBJECTIVE The primary goals of this feasibility study were to (1) assess compliance among providers and their patients with a digital mental health platform protocol, and (2) examine the usability and fidelity of a mobile app through structured participant feedback. METHODS A sample of 30 participants was recruited for a 5-week study from a community-based mental health clinic in Baltimore, Maryland, USA. Inclusion criteria were: aged 18 years or older, having access to a smartphone, and having at least mild-to-moderate depression and/or anxiety as measured by the Patient Health Questionnaire-9 (PHQ-9) and Generalized Anxiety Disorder-7 (GAD-7) scales, respectively. Eligible participants were randomized into one of two study arms: (1) the intervention arm or (2) the waitlist control arm. Participants in the intervention arm were asked to download the Rose app and were prompted to complete clinical assessments (PHQ-9 and GAD-7) every other week, daily mood and anxiety Likert scales, and daily journal entries. The participants in the waitlist arm served as controls for the study and completed the clinical assessments only. Both arms engaged in weekly psychotherapy sessions, with participant in-app input informing the psychotherapy process of the intervention arm, while those in the waitlist control arm continued their standard care. Outcomes of interest included adherence to completion of in-app assessments and usability of the Rose mobile app assessed through the modified Mobile Application Rating Scale. RESULTS Over the study period, a sample of 30 participants used the Rose app 2834 times to complete clinical assessments. On average, 70% (21; 95% CI 61.14%-77.41%) of participants completed mood and anxiety daily check-ins and journal entries 5 days per week. Nearly all participants (29/30, 97%) completed all PHQ-9 and GAD-7 in-app scales during the study. Subjective impressions showed that 73% (22/30) of participants found the mobile app to be engaging and in line with their needs, and approximately 70% (21/30) of participants reported the app functionality and quality of information to be excellent. Additionally, more than two-thirds of the participants felt that their knowledge and awareness of depression and anxiety management improved through using the app. CONCLUSIONS Steady compliance and high app ratings showcase the utility of the Rose mobile mental health app in augmenting the psychotherapy process for patients with mood disorders and improving mental health knowledge. Future studies are needed to further examine the impact of Rose on treatment outcomes. TRIAL REGISTRATION ClinicalTrials.gov NCT04200170; https://clinicaltrials.gov/ct2/show/NCT04200170.",2020,"On average, 70% (21; 95% CI 61.14%-77.41%) of participants completed mood and anxiety daily check-ins and journal entries 5 days per week.","['patients with depressive symptoms', 'Eligible participants', 'Inclusion criteria were: aged 18 years or older, having access to a smartphone, and having at least mild-to-moderate depression and/or anxiety as measured by the', 'A sample of 30 participants was recruited for a 5-week study from a community-based mental health clinic in Baltimore, Maryland, USA', 'patients with mood disorders and improving mental health knowledge']",['Mobile App to Augment Psychotherapy'],"['knowledge and awareness of depression and anxiety management', 'PHQ-9 and GAD-7', 'Subjective impressions', 'Patient Health Questionnaire-9 (PHQ-9) and Generalized Anxiety Disorder-7 (GAD-7) scales', 'modified Mobile Application Rating Scale']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C3839912', 'cui_str': 'Mental health clinic'}, {'cui': 'C0004716', 'cui_str': 'Baltimore'}, {'cui': 'C0024858', 'cui_str': 'Maryland'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}, {'cui': 'C0525045', 'cui_str': 'Mood disorder'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0376554', 'cui_str': 'Knowledge'}]","[{'cui': 'C3658310', 'cui_str': 'Mobile Apps'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0033968', 'cui_str': 'Psychotherapy'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0004448', 'cui_str': 'Cognitive function: awareness'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0871652', 'cui_str': 'Management of anxiety'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0003469', 'cui_str': 'Anxiety disorder'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C3658310', 'cui_str': 'Mobile Apps'}]",30.0,0.108425,"On average, 70% (21; 95% CI 61.14%-77.41%) of participants completed mood and anxiety daily check-ins and journal entries 5 days per week.","[{'ForeName': 'Atif', 'Initials': 'A', 'LastName': 'Adam', 'Affiliation': 'Rose: Smarter Mental Health, Washington, DC, United States.'}, {'ForeName': 'Ameena', 'Initials': 'A', 'LastName': 'Jain', 'Affiliation': 'Key Point Health Services, Inc, Baltimore, MD, United States.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Pletnikova', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Johns Hopkins University, Baltimore, MD, United States.'}, {'ForeName': 'Rishi', 'Initials': 'R', 'LastName': 'Bagga', 'Affiliation': 'Rose: Smarter Mental Health, Washington, DC, United States.'}, {'ForeName': 'Allison', 'Initials': 'A', 'LastName': 'Vita', 'Affiliation': 'Rose: Smarter Mental Health, Washington, DC, United States.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'N Richey', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Johns Hopkins University, Baltimore, MD, United States.'}, {'ForeName': 'Neda', 'Initials': 'N', 'LastName': 'Gould', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Johns Hopkins University, Baltimore, MD, United States.'}, {'ForeName': 'Supriya', 'Initials': 'S', 'LastName': 'Munshaw', 'Affiliation': 'Carey Business School, Johns Hopkins University, Baltimore, MD, United States.'}, {'ForeName': 'Kavi', 'Initials': 'K', 'LastName': 'Misrilall', 'Affiliation': 'Rose: Smarter Mental Health, Washington, DC, United States.'}, {'ForeName': 'Matthew E', 'Initials': 'ME', 'LastName': 'Peters', 'Affiliation': 'Rose: Smarter Mental Health, Washington, DC, United States.'}]",JMIR formative research,['10.2196/17722'] 2818,32618578,Effects of a 12-Week Multifaceted Wearable-Based Program for People With Knee Osteoarthritis: Randomized Controlled Trial.,"BACKGROUND Current guidelines emphasize an active lifestyle in the management of knee osteoarthritis (OA), but up to 90% of patients with OA are inactive. In a previous study, we demonstrated that an 8-week physiotherapist (PT)-led counseling intervention, with the use of a Fitbit, improved step count and quality of life in patients with knee OA, compared with a control. OBJECTIVE This study aimed to examine the effect of a 12-week, multifaceted wearable-based program on physical activity and patient outcomes in patients with knee OA. METHODS This was a randomized controlled trial with a delay-control design. The immediate group (IG) received group education, a Fitbit, access to FitViz (a Fitbit-compatible app), and 4 biweekly phone calls from a PT over 8 weeks. Participants then continued using Fitbit and FitViz independently up to week 12. The delay group (DG) received a monthly electronic newsletter in weeks 1 to 12 and started the same intervention in week 14. Participants were assessed in weeks 13, 26, and 39. The primary outcome was time spent in daily moderate-to-vigorous physical activity (MVPA; in bouts ≥10 min) measured with a SenseWear Mini. Secondary outcomes included daily steps, time spent in purposeful activity and sedentary behavior, Knee Injury and OA Outcome Score, Patient Health Questionnaire-9, Partners in Health Scale, Theory of Planned Behavior Questionnaire, and Self-Reported Habit Index. RESULTS We enrolled 51 participants (IG: n=26 and DG: n=25). Compared with the IG, the DG accumulated significantly more MVPA time at baseline. The adjusted mean difference in MVPA was 13.1 min per day (95% CI 1.6 to 24.5). A significant effect was also found in the adjusted mean difference in perceived sitting habit at work (0.7; 95% CI 0.2 to 1.2) and during leisure activities (0.7; 95% CI 0.2 to 1.2). No significant effect was found in the remaining secondary outcomes. CONCLUSIONS A 12-week multifaceted program with the use of a wearable device, an app, and PT counseling improved physical activity in people with knee OA. TRIAL REGISTRATION ClinicalTrials.gov NCT02585323; https://clinicaltrials.gov/ct2/show/NCT02585323.",2020,The adjusted mean difference in MVPA was 13.1 min per day (95% CI 1.6 to 24.5).,"['enrolled 51 participants (IG: n=26 and DG: n=25', 'people with knee OA', 'patients with knee OA', 'People With Knee Osteoarthritis']","['12-Week Multifaceted Wearable-Based Program', 'PT counseling', 'physiotherapist (PT)-led counseling intervention', 'multifaceted wearable-based program']","['daily steps, time spent in purposeful activity and sedentary behavior, Knee Injury and OA Outcome Score, Patient Health Questionnaire-9, Partners in Health Scale, Theory of Planned Behavior Questionnaire, and Self-Reported Habit Index', 'perceived sitting habit', 'physical activity', 'MVPA', 'MVPA time', 'time spent in daily moderate-to-vigorous physical activity (MVPA; in bouts ≥10 min) measured with a SenseWear Mini']","[{'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapist'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0427149', 'cui_str': 'Foot-drop gait'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C1532253', 'cui_str': 'Sedentary lifestyle'}, {'cui': 'C3476088', 'cui_str': 'Knee Injury and Osteoarthritis Outcome Score'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0682323', 'cui_str': 'Partner in relationship'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0018464', 'cui_str': 'Habits'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0037216', 'cui_str': 'SITS'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0445542', 'cui_str': 'Mini'}]",51.0,0.150513,The adjusted mean difference in MVPA was 13.1 min per day (95% CI 1.6 to 24.5).,"[{'ForeName': 'Linda C', 'Initials': 'LC', 'LastName': 'Li', 'Affiliation': 'Department of Physical Therapy, University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'Lynne M', 'Initials': 'LM', 'LastName': 'Feehan', 'Affiliation': 'Department of Physical Therapy, University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Xie', 'Affiliation': 'Arthritis Research Canada, Richmond, BC, Canada.'}, {'ForeName': 'Na', 'Initials': 'N', 'LastName': 'Lu', 'Affiliation': 'Arthritis Research Canada, Richmond, BC, Canada.'}, {'ForeName': 'Christopher D', 'Initials': 'CD', 'LastName': 'Shaw', 'Affiliation': 'School of Interactive Art & Technology, Simon Fraser University, Burnaby, BC, Canada.'}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Gromala', 'Affiliation': 'School of Interactive Art & Technology, Simon Fraser University, Burnaby, BC, Canada.'}, {'ForeName': 'Siyi', 'Initials': 'S', 'LastName': 'Zhu', 'Affiliation': 'Arthritis Research Canada, Richmond, BC, Canada.'}, {'ForeName': 'J Antonio', 'Initials': 'JA', 'LastName': 'Aviña-Zubieta', 'Affiliation': 'Arthritis Research Canada, Richmond, BC, Canada.'}, {'ForeName': 'Alison M', 'Initials': 'AM', 'LastName': 'Hoens', 'Affiliation': 'Department of Physical Therapy, University of British Columbia, Vancouver, BC, Canada.'}, {'ForeName': 'Cheryl', 'Initials': 'C', 'LastName': 'Koehn', 'Affiliation': 'Arthritis Consumer Experts, Vancouver, BC, Canada.'}, {'ForeName': 'Johnathan', 'Initials': 'J', 'LastName': 'Tam', 'Affiliation': 'Arthritis Research Canada, Richmond, BC, Canada.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Therrien', 'Affiliation': 'Arthritis Research Canada, Richmond, BC, Canada.'}, {'ForeName': 'Anne F', 'Initials': 'AF', 'LastName': 'Townsend', 'Affiliation': 'Division of Health Research, Faculty of Health & Medicine, Lancaster University, Lancashire, United Kingdom.'}, {'ForeName': 'Gregory', 'Initials': 'G', 'LastName': 'Noonan', 'Affiliation': 'Mary Pack Arthritis Program, Vancouver General Hospital, Vancouver, BC, Canada.'}, {'ForeName': 'Catherine L', 'Initials': 'CL', 'LastName': 'Backman', 'Affiliation': 'Arthritis Research Canada, Richmond, BC, Canada.'}]",JMIR mHealth and uHealth,['10.2196/19116'] 2819,32618621,Concomitant Benefits of an Auricular Acupressure Intervention for Women With Cancer on Family Caregiver Sleep Quality.,"BACKGROUND Sleep disturbance is a frequent and significant problem challenge for family caregivers of patients with cancer. A previously tested 6-week auricular acupressure intervention was found to reduce symptom burden in women with cancer. It is possible that such an intervention has a concomitant benefit for family caregivers. OBJECTIVES The aim of this study was to explore if the effects of an auricular acupressure intervention on major symptoms experienced by women with ovarian cancer improves the sleep quality of family caregivers. METHODS A quasi-randomized controlled trial with a repeated-measures design was used. Family caregivers (n = 68) of cancer patients were recruited and completed the Pittsburgh Sleep Quality Index on 4 occasions. Demographic information included age, sex, duration of caring role, and relationship to the patient. RESULTS Family members with a longer duration of caregiving reported more sleep disturbance at baseline. As the symptom burden of treated women decreased, their family caregivers reported improved Pittsburgh Sleep Quality Index scores at 4 weeks (time 2; Cohen d = 1.075) and 6 weeks (time 3; Cohen d = 1.022). CONCLUSIONS Reducing the symptom burden of patients with cancer can improve the sleep quality of family caregivers. IMPLICATIONS FOR PRACTICE Auricular acupressure is a noninvasive and easy-to-apply intervention that can be applied by caregivers to assist their family member. Nursing staff can implement and test the acupressure intervention into their clinical practice and better support family-based strategies and interventions. Further studies with larger samples are needed to confirm our findings.",2020,"IMPLICATIONS FOR PRACTICE Auricular acupressure is a noninvasive and easy-to-apply intervention that can be applied by caregivers to assist their family member.","['Family caregivers (n = 68) of cancer patients', 'patients with cancer', 'women with ovarian cancer', 'family caregivers of patients with cancer', 'Women With Cancer on Family Caregiver Sleep Quality', 'women with cancer']","['auricular acupressure intervention', 'Auricular Acupressure Intervention', 'acupressure intervention']","['Pittsburgh Sleep Quality Index scores', 'symptom burden', 'sleep quality of family caregivers', 'sleep disturbance', 'Pittsburgh Sleep Quality Index']","[{'cui': 'C0086279', 'cui_str': 'Family Caregivers'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0919267', 'cui_str': 'Neoplasm of ovary'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}]","[{'cui': 'C1522191', 'cui_str': 'Otic route'}, {'cui': 'C0282614', 'cui_str': 'Acupressure'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C4545801', 'cui_str': 'Pittsburgh Sleep Quality Index score'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0086279', 'cui_str': 'Family Caregivers'}, {'cui': 'C0037317', 'cui_str': 'Disturbance in sleep behavior'}, {'cui': 'C3697468', 'cui_str': 'Pittsburgh sleep quality index'}]",68.0,0.0517437,"IMPLICATIONS FOR PRACTICE Auricular acupressure is a noninvasive and easy-to-apply intervention that can be applied by caregivers to assist their family member.","[{'ForeName': 'Ting-Ting', 'Initials': 'TT', 'LastName': 'Wu', 'Affiliation': 'Author Affiliations: Kaohsiung Veterans General Hospital, Kaohsiung, Taiwan (Ms Wu, Dr Pan, Ms Kuo, and Dr Chen); Perinatal Mental Health, School of Nursing & Midwifery, Griffith University, Brisbane, Australia (Dr Creedy); Department of Nursing, Tzu-Chi University, Hualien, Taiwan (Dr Tsao).'}, {'ForeName': 'Hung-Wei', 'Initials': 'HW', 'LastName': 'Pan', 'Affiliation': ''}, {'ForeName': 'Hui-Chen', 'Initials': 'HC', 'LastName': 'Kuo', 'Affiliation': ''}, {'ForeName': 'San-Nung', 'Initials': 'SN', 'LastName': 'Chen', 'Affiliation': ''}, {'ForeName': 'Debra K', 'Initials': 'DK', 'LastName': 'Creedy', 'Affiliation': ''}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Tsao', 'Affiliation': ''}]",Cancer nursing,['10.1097/NCC.0000000000000842'] 2820,32618695,Acute Kidney Injury in Acute Ischemic Stroke Patients in Clinical Trials.,"OBJECTIVES Acute ischemic stroke patients are at risk of acute kidney injury due to volume depletion, contrast exposure, and preexisting comorbid diseases. We determined the occurrence rate and identified predictors associated with acute kidney injury in acute ischemic stroke patients. SETTING Multiple specialized ICUs within academic medical centers. DESIGN Post hoc analysis of pooled data from prospective randomized clinical trials. PATIENTS Acute ischemic stroke patients recruited within 3 hours or within 5 hours of symptom onset. INTERVENTIONS IV recombinant tissue plasminogen activator, endovascular treatment, IV albumin, or placebo. MEASUREMENTS AND MAIN RESULTS Serum creatinine levels from baseline and within day 5 or discharge were used to classify acute kidney injury classification into stages. Any increase in serum creatinine was seen in 697 (36.1%) and acute kidney injury was seen in 68 (3.5%) of 1,931 patients with acute ischemic stroke. Severity of acute kidney injury was grade I, II, and III in 3.1%, 0.4%, and 0.05% patients, respectively. Patients with albumin (5.5% compared with 2.6%; p = 0.001), preexisting hypertension (4.3% compared with 1.5%; p = 0.0041), and preexisting renal disease (9.1% compared with 3.0%; p < 0.0001) had higher risk of acute kidney injury. The risk of acute kidney injury was lower between those who either underwent CT angiography (2.0% compared with 4.7%; p = 0.0017) or endovascular treatment (1.6% compared with 4.2%; p = 0.0071). In the multivariate analysis, hypertension (odds ratio, 2.6; 95% CI, 1.2-5.6) and renal disease (odds ratio, 3.5; 95% CI, 1.9-6.5) were associated with acute kidney injury. The risk of death was significantly higher among patients with acute kidney injury (odds ratio, 2.7; 95% CI, 1.4-4.9) after adjusting for age and National Institutes of Health Stroke Scale score strata. CONCLUSIONS The occurrence rate of acute kidney injury in acute ischemic stroke patients was low and was not higher in patients who underwent CT angiogram or those who received endovascular treatment. Occurrence of acute kidney injury increased the risk of death within 3 months among acute ischemic stroke patients.",2020,"In the multivariate analysis, hypertension (odds ratio, 2.6; 95% CI, 1.2-5.6) and renal disease (odds ratio, 3.5; 95% CI, 1.9-6.5) were associated with acute kidney injury.","['1,931 patients with acute ischemic stroke', 'Multiple specialized ICUs within academic medical centers', 'Acute Ischemic Stroke Patients', 'acute ischemic stroke patients', 'Acute ischemic stroke patients recruited within 3 hours or within 5 hours of symptom onset', 'Acute ischemic stroke patients']","['CT angiography', 'recombinant tissue plasminogen activator, endovascular treatment, IV albumin, or placebo', 'CT angiogram']","['preexisting renal disease', 'risk of death', 'serum creatinine', 'renal disease', 'Serum creatinine levels', 'acute kidney injury', 'preexisting hypertension', 'risk of acute kidney injury']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0205555', 'cui_str': 'Special'}, {'cui': 'C0000872', 'cui_str': 'Academic medical center'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C1442467', 'cui_str': '5 hours'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}]","[{'cui': 'C1536105', 'cui_str': 'CT angiography'}, {'cui': 'C0032143', 'cui_str': 'alteplase'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}]","[{'cui': 'C0022658', 'cui_str': 'Kidney disease'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0201976', 'cui_str': 'Creatinine measurement, serum'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}]",1931.0,0.150194,"In the multivariate analysis, hypertension (odds ratio, 2.6; 95% CI, 1.2-5.6) and renal disease (odds ratio, 3.5; 95% CI, 1.9-6.5) were associated with acute kidney injury.","[{'ForeName': 'Adnan I', 'Initials': 'AI', 'LastName': 'Qureshi', 'Affiliation': 'Department of Neurology, Zeenat Qureshi Stroke Institute, St. Cloud, MN.'}, {'ForeName': 'Hunain', 'Initials': 'H', 'LastName': 'Aslam', 'Affiliation': 'Department of Neurology, Zeenat Qureshi Stroke Institute, St. Cloud, MN.'}, {'ForeName': 'Werdah', 'Initials': 'W', 'LastName': 'Zafar', 'Affiliation': 'Department of Neurology, Zeenat Qureshi Stroke Institute, St. Cloud, MN.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Huang', 'Affiliation': 'Department of Neurology, Zeenat Qureshi Stroke Institute, St. Cloud, MN.'}, {'ForeName': 'Iryna', 'Initials': 'I', 'LastName': 'Lobanova', 'Affiliation': 'Department of Neurology, Zeenat Qureshi Stroke Institute, St. Cloud, MN.'}, {'ForeName': 'Syed H', 'Initials': 'SH', 'LastName': 'Naqvi', 'Affiliation': 'Department of Medicine, University of Missouri, Columbia, MO.'}, {'ForeName': 'Kunal', 'Initials': 'K', 'LastName': 'Malhotra', 'Affiliation': 'Department of Medicine, University of Missouri, Columbia, MO.'}, {'ForeName': 'Niraj', 'Initials': 'N', 'LastName': 'Arora', 'Affiliation': 'Department of Neurology, University of Missouri, Columbia, MO.'}, {'ForeName': 'Premkumar N', 'Initials': 'PN', 'LastName': 'Chandrasekaran', 'Affiliation': 'Department of Neurology, University of Missouri, Columbia, MO.'}, {'ForeName': 'Farhan', 'Initials': 'F', 'LastName': 'Siddiq', 'Affiliation': 'Division of Neurosurgery, Department of Surgery, University of Missouri, Columbia, MO.'}, {'ForeName': 'Brandi R', 'Initials': 'BR', 'LastName': 'French', 'Affiliation': 'Department of Neurology, University of Missouri, Columbia, MO.'}, {'ForeName': 'Camilo R', 'Initials': 'CR', 'LastName': 'Gomez', 'Affiliation': 'Department of Neurology, University of Missouri, Columbia, MO.'}]",Critical care medicine,['10.1097/CCM.0000000000004464'] 2821,32618713,"Antenatal uterotonics as a risk factor for intrapartum stillbirth and first-day death in Haryana, India: a nested case-control study.","BACKGROUND Use of uterotonics like oxytocin to induce or augment labor has been shown to reduce placental perfusion and oxygen supply to the fetus and studies indicate that it may increase the risk of stillbirth and neonatal asphyxia. Antenatal use of uterotonics, even without the required fetal monitoring and prompt access to cesarean section, is widespread, yet no study has adequately estimated the risk of intrapartum stillbirth and early neonatal deaths ascribed to such use. We conducted a case-control study to estimate this risk. METHODS We conducted a population-based case-control study nested in a cluster-randomized trial. From 2008 to 2010, we followed pregnant women in rural Haryana, India, monthly until delivery. We visited all live-born infants on day 29 to ascertain whether they were alive. We conducted verbal autopsies for stillbirths and neonatal deaths. Cases (n=2,076) were the intrapartum stillbirths and day-1 deaths (early deaths), and controls (n=532) were live-born babies who died between day 8 and 28 (late deaths). RESULTS Antenatal administration of uterotonics preceded 74% of early and 62% of late deaths, translating to an adjusted odds ratio [95% confidence interval (CI)] for early deaths of 1.7 (95%CI = 1.4, 2.1), and a population attributable risk of 31% (95%CI = 22%, 38%). CONCLUSIONS Antenatal administration of uterotonics was associated with a substantially increased risk of intrapartum stillbirth and day-1 death.",2020,"CONCLUSIONS Antenatal administration of uterotonics was associated with a substantially increased risk of intrapartum stillbirth and day-1 death.","['From 2008 to 2010, we followed pregnant women in rural Haryana, India, monthly until delivery']",[],"['risk of intrapartum stillbirth and day-1 death', 'intrapartum stillbirths and day-1 deaths (early deaths']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0021201', 'cui_str': 'India'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C1720302', 'cui_str': 'Until'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}]",[],"[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0456337', 'cui_str': 'Intrapartum'}, {'cui': 'C0595939', 'cui_str': 'Stillbirth'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1279919', 'cui_str': 'Early'}]",,0.117976,"CONCLUSIONS Antenatal administration of uterotonics was associated with a substantially increased risk of intrapartum stillbirth and day-1 death.","[{'ForeName': 'Sanjana', 'Initials': 'S', 'LastName': 'Brahmawar Mohan', 'Affiliation': 'Centre for Health Research and Development, Society for Applied Studies (SAS), New Delhi, India.'}, {'ForeName': 'Halvor', 'Initials': 'H', 'LastName': 'Sommerfelt', 'Affiliation': 'Centre for Intervention Science in Maternal and Child Health (CISMAC) and Centre for International Health (CIH), University of Bergen, Bergen, Norway.'}, {'ForeName': 'J Frederik', 'Initials': 'JF', 'LastName': 'Frøen', 'Affiliation': 'Centre for Intervention Science in Maternal and Child Health (CISMAC) and Centre for International Health (CIH), University of Bergen, Bergen, Norway.'}, {'ForeName': 'Sunita', 'Initials': 'S', 'LastName': 'Taneja', 'Affiliation': 'Centre for Health Research and Development, Society for Applied Studies (SAS), New Delhi, India.'}, {'ForeName': 'Tivendra', 'Initials': 'T', 'LastName': 'Kumar', 'Affiliation': 'Centre for Health Research and Development, Society for Applied Studies (SAS), New Delhi, India.'}, {'ForeName': 'Kiran', 'Initials': 'K', 'LastName': 'Bhatia', 'Affiliation': 'Centre for Health Research and Development, Society for Applied Studies (SAS), New Delhi, India.'}, {'ForeName': 'Lize', 'Initials': 'L', 'LastName': 'van der Merwe', 'Affiliation': 'Centre for Intervention Science in Maternal and Child Health (CISMAC) and Centre for International Health (CIH), University of Bergen, Bergen, Norway.'}, {'ForeName': 'Rajiv', 'Initials': 'R', 'LastName': 'Bahl', 'Affiliation': 'Department of Maternal, Newborn, Child and Adolescent Health, World Health Organization, Geneva, Switzerland.'}, {'ForeName': 'Jose C', 'Initials': 'JC', 'LastName': 'Martines', 'Affiliation': 'Centre for Intervention Science in Maternal and Child Health (CISMAC) and Centre for International Health (CIH), University of Bergen, Bergen, Norway.'}, {'ForeName': 'Sarmila', 'Initials': 'S', 'LastName': 'Mazumder', 'Affiliation': 'Centre for Health Research and Development, Society for Applied Studies (SAS), New Delhi, India.'}, {'ForeName': 'Nita', 'Initials': 'N', 'LastName': 'Bhandari', 'Affiliation': 'Centre for Health Research and Development, Society for Applied Studies (SAS), New Delhi, India.'}]","Epidemiology (Cambridge, Mass.)",['10.1097/EDE.0000000000001224'] 2822,32618829,Magnesium Sulfate Administration in Moderate Coronary Artery Disease Patients Improves Atherosclerotic Risk Factors: A Double Blind Clinical Trial Study.,"Magnesium (Mg) deficiency is known to promote vascular and cardiac dysfunctions such as atherosclerosis. This study investigated the effect of oral MgSO4 therapy to improve lipid profile and serum oxidized LDL (oxLDL) level and its receptor (LOX1) in moderate coronary atherosclerotic patients. In this randomized double blind placebo-controlled clinical trial study, sixty-four patients with moderate coronary artery disease were selected according to angiography findings. Participants were divided into two groups including Mg-treated (n=32) and placebo(n=32 ) The patients received either placebo or MgSO4 supplement capsule containing 300 mg MgSO4 for 6 months on a daily basis. Lipid profile, HbA1c, 2h postprandial (2hpp) blood glucose, fasting blood sugar (FBS), serum SGOT, SGPT, ox-LDL and lectin-like ox-LDL receptor 1(LOX1) concentrations were measured at baseline and every three months. HbA1c, serum LOX1 and oxLDL concentrations were significantly lower in Mg-treated than placebo group three months after MgSO4 administration. 2hpp, serum LDL-C, SGPT, SGOT levels and HbA1c levels significantly improved in Mg-treated group compared to placebo received group. Overall, the results of this study showed that magnesium treatment improved some of the major risk factors of atherosclerosis. According to the results of liver function tests (SGOT and SGPT), magnesium therapy seems to be safe in patients with moderate atherosclerotic plaque. Therefore, it is suggested that magnesium to be used along with other atherosclerosis control drugs.",2020,"HbA1c, serum LOX1 and oxLDL concentrations were significantly lower in Mg-treated than placebo group three months after MgSO4 administration.","['sixty-four patients with moderate coronary artery disease were selected according to angiography findings', 'moderate coronary atherosclerotic patients', 'patients with moderate atherosclerotic plaque', 'Moderate Coronary Artery Disease Patients Improves Atherosclerotic Risk Factors']","['oral MgSO4 therapy', 'Magnesium Sulfate Administration', 'placebo or MgSO4 supplement capsule containing 300 mg MgSO4', 'Magnesium (Mg) deficiency', 'Mg-treated (n=32) and placebo(n=32 ', 'magnesium', 'placebo']","['Lipid profile, HbA1c, 2h postprandial (2hpp) blood glucose, fasting blood sugar (FBS), serum SGOT, SGPT, ox-LDL and lectin-like ox-LDL receptor 1(LOX1) concentrations', 'HbA1c, serum LOX1 and oxLDL concentrations', 'serum LDL-C, SGPT, SGOT levels and HbA1c levels', 'lipid profile and serum oxidized LDL (oxLDL) level and its receptor (LOX1', 'major risk factors of atherosclerosis']","[{'cui': 'C4517839', 'cui_str': '64'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C2936350', 'cui_str': 'Atherosclerotic Plaques'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0024480', 'cui_str': 'Magnesium Sulfate'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0024473', 'cui_str': 'Magnesium deficiency'}, {'cui': 'C0024467', 'cui_str': 'Magnesium'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}]","[{'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0201899', 'cui_str': 'Aspartate aminotransferase measurement'}, {'cui': 'C0036828', 'cui_str': 'SGPT'}, {'cui': 'C0348035', 'cui_str': 'Oxidized low density lipoprotein'}, {'cui': 'C0023206', 'cui_str': 'Lectin'}, {'cui': 'C0536243', 'cui_str': 'Oxidized LDL Receptor'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0035648', 'cui_str': 'Risk factor'}, {'cui': 'C0004153', 'cui_str': 'Atherosclerosis'}]",64.0,0.22722,"HbA1c, serum LOX1 and oxLDL concentrations were significantly lower in Mg-treated than placebo group three months after MgSO4 administration.","[{'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Farshidi', 'Affiliation': 'Cardiovascular research center, Hormozgan University of Medical Sciences, Bandar Abbas, Iran.'}, {'ForeName': 'Ali Reza', 'Initials': 'AR', 'LastName': 'Sobhani', 'Affiliation': 'Clinical pathology department, Faculty of medicine, Hormozgan University of Medical Sciences, Bandar Abbas, Iran.'}, {'ForeName': 'Mahdiye', 'Initials': 'M', 'LastName': 'Eslami', 'Affiliation': 'Cardiovascular research center, Hormozgan University of Medical Sciences, Bandar Abbas, Iran.'}, {'ForeName': 'Fariba', 'Initials': 'F', 'LastName': 'Azarkish', 'Affiliation': 'Molecular Medicine Research Center, Hormozgan Health Institute, Hormozgan University of Medical Sciences, Bandar Abbas, Iran.'}, {'ForeName': 'Ebrahim', 'Initials': 'E', 'LastName': 'Eftekhar', 'Affiliation': 'Endocrinology and Metabolism Research Center, Hormozgan University of Medical Sciences, Bandar Abbas, Iran.'}, {'ForeName': 'Mansoor', 'Initials': 'M', 'LastName': 'Keshavarz', 'Affiliation': 'Physiology department, Faculty of medicine, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Nepton', 'Initials': 'N', 'LastName': 'Soltani', 'Affiliation': 'Physiology department, School of medicine, Isfahan University of Medical Sciences, Isfahan, Iran.'}]",Journal of cardiovascular pharmacology,['10.1097/FJC.0000000000000874'] 2823,32618838,Is Noninvasive Vagus Nerve Stimulation a Safe and Effective Alternative to Medication for Acute Migraine Control?,"BACKGROUND Noninvasive neuromodulation devices have been used for a variety of headache disorders, including cluster and migraine, since recently being cleared by the Federal Drug Administration. Although these devices have been touted as low-risk options for improved headache control, the data behind actual efficacy endpoints remain unclear. OBJECTIVE To critically assess current evidence regarding the efficacy of the noninvasive vagus nerve stimulator (nVNS) device for acute migraine management. METHODS The objective was addressed through the development of a structured critically appraised topic. This included a clinical scenario with a clinical question, literature search strategy, critical appraisal, results, evidence summary, commentary, and bottom line conclusions.Participants included consultant and resident neurologists, a medical librarian, clinical epidemiologists, and a content expert in the field of headache. RESULTS A randomized, double-blind, sham-controlled clinical trial was selected for critical appraisal. In this trial, the primary endpoint (pain freedom at 120 min after use of nVNS for first acute migraine attack) was not met when compared with sham device (30.4% for nVNS vs. 19.7% for sham; P=0.067). However, there were statistically significant differences found for various secondary endpoints favoring nVNS, such as pain freedom rates at 30 and 60 minutes, pain relief at 120 minutes, and mean percentage pain score reduction rates at 60 and 120 minutes. CONCLUSIONS When comparing nVNS with sham, no statistically significant differences were found with regards to the primary endpoint of pain freedom at 120 minutes, although differences were found with various secondary endpoints and post hoc analysis. nVNS is likely a safe alternative to medications.",2020,"When comparing nVNS with sham, no statistically significant differences were found with regards to the primary endpoint of pain freedom at 120 minutes, although differences were found with various secondary endpoints and post hoc analysis.","['Participants included consultant and resident neurologists, a medical librarian, clinical epidemiologists, and a content expert in the field of headache']","['nVNS', 'noninvasive vagus nerve stimulator (nVNS) device']","['primary endpoint (pain freedom', 'pain freedom rates', 'pain freedom', 'pain relief', 'mean percentage pain score reduction rates']","[{'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0009817', 'cui_str': 'Consultant'}, {'cui': 'C1320928', 'cui_str': 'Resident physician'}, {'cui': 'C0237426', 'cui_str': 'Neurologist'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0079695', 'cui_str': 'Librarian'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1516908', 'cui_str': 'Epidemiologist'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0440042', 'cui_str': ""Field's stain""}, {'cui': 'C0018681', 'cui_str': 'Headache'}]","[{'cui': 'C2959478', 'cui_str': 'Vagal nerve stimulator'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}]","[{'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0451615', 'cui_str': 'Pain relief'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",,0.239962,"When comparing nVNS with sham, no statistically significant differences were found with regards to the primary endpoint of pain freedom at 120 minutes, although differences were found with various secondary endpoints and post hoc analysis.","[{'ForeName': 'Benzion', 'Initials': 'B', 'LastName': 'Blech', 'Affiliation': 'Departments of Neurology.'}, {'ForeName': 'Amaal J', 'Initials': 'AJ', 'LastName': 'Starling', 'Affiliation': 'Departments of Neurology.'}, {'ForeName': 'Lisa A', 'Initials': 'LA', 'LastName': 'Marks', 'Affiliation': 'Library Services, Mayo Clinic, Scottsdale/Phoenix, AZ.'}, {'ForeName': 'Dean M', 'Initials': 'DM', 'LastName': 'Wingerchuk', 'Affiliation': 'Departments of Neurology.'}, {'ForeName': 'Cumara B', 'Initials': 'CB', 'LastName': ""O'Carroll"", 'Affiliation': 'Departments of Neurology.'}]",The neurologist,['10.1097/NRL.0000000000000274'] 2824,32618857,A Randomized Controlled Study Assessing the Effects of a Shoe Lift Under the Nonparetic Leg on Balance Performance in Individuals With Chronic Stroke.,"BACKGROUND AND PURPOSE Improvement of balance and postural stability is an important goal in stroke rehabilitation. The purpose of this study was to investigate the effects of a shoe lift under the nonparetic leg on balance function and balance confidence in persons with chronic stroke. METHODS Thirty-six individuals with chronic stroke (21 males and 15 females), who were able to walk independently and showed stance asymmetry, were randomized to a shoe insert and a control group. The interventions included a 6-week balance training program, in conjunction with a shoe lift under the nonaffected leg (shoe insert group, n = 18), or balance training alone (control group, n = 18). The outcome measures were weight-bearing asymmetry (WBA), root mean square (RMS) of anterior-posterior (AP) and medial-lateral (ML) center-of-pressure (COP) velocity asymmetry, Berg Balance Scale (BBS), and Activities-specific Balance Confidence (ABC) Scale. These were measured in both groups at baseline, after the intervention, and at a 3-month follow-up. A repeated-measure multivariate analysis of variance was conducted to evaluate the impact of 2 different interventions on balance measures, across the 3 periods. RESULTS AND DISCUSSION No significant between-group differences were found for demographics and stroke-related characteristics of participants (P > .05). The outcome measures between the 2 groups were not significantly different at baseline (P > .05). There were between-group differences for WBA and the RMS of AP COP velocity asymmetry after the intervention and at the 3-month follow-up (P < .05). No significant difference in the RMS of ML COP velocity asymmetry, BBS, and ABC was identified between the 2 groups after the intervention and at the 3-month follow-up (P > .05). CONCLUSION The results indicated that the use of a shoe lift under the nonaffected leg in the context of a balance training program could result in a greater improvement in static standing balance as compared with balance training alone in an individual with chronic stroke. TRIAL REGISTRATION The study was retrospectively registered in the Iranian Registry of Clinical Trials (IRCT20190603043808N1).",2020,"No significant difference in the RMS of ML COP velocity asymmetry, BBS, and ABC was identified between the 2 groups after the intervention and at the 3-month follow-up (P > .05). ","['Thirty-six individuals with chronic stroke (21 males and 15 females), who were able to walk independently and showed stance asymmetry', 'persons with chronic stroke', 'Individuals With Chronic Stroke']","['6-week balance training program, in conjunction with a shoe lift under the nonaffected leg (shoe insert group, n = 18), or balance training alone (control', 'shoe lift under the nonparetic leg', 'Shoe Lift Under the Nonparetic Leg']","['WBA and the RMS of AP COP velocity asymmetry', 'balance function and balance confidence', 'Balance Performance', 'static standing balance', 'RMS of ML COP velocity asymmetry, BBS, and ABC', 'weight-bearing asymmetry (WBA), root mean square (RMS) of anterior-posterior (AP) and medial-lateral (ML) center-of-pressure (COP) velocity asymmetry, Berg Balance Scale (BBS), and Activities-specific Balance Confidence (ABC) Scale']","[{'cui': 'C4319606', 'cui_str': '36'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C3536593', 'cui_str': 'Chronic cerebrovascular accident'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C2712089', 'cui_str': 'Able to walk'}, {'cui': 'C0332514', 'cui_str': 'Asymmetry'}]","[{'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0036988', 'cui_str': 'Shoes'}, {'cui': 'C0181620', 'cui_str': 'Hoist'}, {'cui': 'C0023216', 'cui_str': 'Lower limb structure'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0085086', 'cui_str': 'Weight-bearing'}, {'cui': 'C0332514', 'cui_str': 'Asymmetry'}, {'cui': 'C0040452', 'cui_str': 'Tooth root structure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0205120', 'cui_str': 'Square'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0237529', 'cui_str': 'Self-confidence'}, {'cui': 'C0441463', 'cui_str': 'Static'}, {'cui': 'C0205098', 'cui_str': 'Medial'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C1998325', 'cui_str': 'Berg balance scale'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0175659', 'cui_str': 'Scale'}]",36.0,0.0190842,"No significant difference in the RMS of ML COP velocity asymmetry, BBS, and ABC was identified between the 2 groups after the intervention and at the 3-month follow-up (P > .05). ","[{'ForeName': 'Mania', 'Initials': 'M', 'LastName': 'Sheikh', 'Affiliation': 'Department of Physical Therapy, School of Paramedical Sciences, Mashhad University of Medical Sciences, Mashhad, Iran.'}, {'ForeName': 'Hossein', 'Initials': 'H', 'LastName': 'Asghar Hosseini', 'Affiliation': ''}]",Journal of geriatric physical therapy (2001),['10.1519/JPT.0000000000000278'] 2825,32618875,Does a screening trial for spinal cord stimulation in patients with chronic pain of neuropathic origin have clinical utility and cost-effectiveness (TRIAL-STIM)? a randomised controlled trial.,"Spinal cord stimulation (SCS) is an established treatment of chronic neuropathic pain. Although a temporary SCS screening trial is widely used to determine whether a patient should receive permanent SCS implant, its evidence base is limited. We aimed to establish the clinical utility, diagnostic accuracy, and cost-effectiveness of an SCS screening trial. A multicentre single-blind, parallel two-group randomised controlled superiority trial was undertaken at three centres in United Kingdom. Patients were randomised 1:1 to either SCS screening trial strategy (TG) or no trial screening strategy (NTG). Treatment was open label, but outcome assessors were masked. The primary outcome measure was numerical rating scale (NRS) pain at six-months follow-up. Between June 2017 and September 2018, 105 participants were enrolled and randomised (TG=54, NTG=51). Mean NRS pain decreased from 7.47 at baseline (before SCS implantation) to 4.28 at 6-months in TG and from 7.54 to 4.49 in NTG (mean group difference: 0.2, 95% CI: -1.2 to 0.9, p=0.89). We found no difference between TG and NTG in the proportion of pain responders or other secondary outcomes. SCS screening trial had a sensitivity of 100% (95% CI: 78 to 100) and specificity of 8% (95% CI: 1 to 25). The mean incremental cost-effectiveness ratio of TG versus NTG was £78,895 per additional quality-adjusted life-year (QALY) gained. In conclusion, although the SCS screening trial may have some diagnostic utility, there was no evidence that an SCS screening trial strategy provides superior patient outcomes or is cost-effective compared to a no trial screening approach.",2020,SCS screening trial had a sensitivity of 100% (95% CI: 78 to 100) and specificity of 8% (95% CI: 1 to 25).,"['Between June 2017 and September 2018, 105 participants were enrolled and randomised (TG=54, NTG=51', 'patients with chronic pain of neuropathic origin']","['SCS screening trial strategy (TG) or no trial screening strategy (NTG', 'Spinal cord stimulation (SCS', 'TG and NTG']","['mean incremental cost-effectiveness ratio of TG', 'numerical rating scale (NRS) pain', 'Mean NRS pain']","[{'cui': 'C4319547', 'cui_str': '105'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain'}, {'cui': 'C0439659', 'cui_str': 'Origins'}]","[{'cui': 'C0394477', 'cui_str': 'Neurostimulation of spinal cord tissue'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",105.0,0.379353,SCS screening trial had a sensitivity of 100% (95% CI: 78 to 100) and specificity of 8% (95% CI: 1 to 25).,"[{'ForeName': 'Sam', 'Initials': 'S', 'LastName': 'Eldabe', 'Affiliation': 'Department of Pain Medicine, The James Cook University Hospital, Middlesbrough, UK.'}, {'ForeName': 'Rui V', 'Initials': 'RV', 'LastName': 'Duarte', 'Affiliation': 'Liverpool Reviews and Implementation Group, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Ashish', 'Initials': 'A', 'LastName': 'Gulve', 'Affiliation': 'Department of Pain Medicine, The James Cook University Hospital, Middlesbrough, UK.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Thomson', 'Affiliation': 'Department of Anaesthesia, Basildon and Thurrock University Hospitals, Basildon, UK.'}, {'ForeName': 'Ganesan', 'Initials': 'G', 'LastName': 'Baranidharan', 'Affiliation': 'Leeds Neuromodulation Centre, Leeds Teaching Hospitals, Leeds, UK.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Houten', 'Affiliation': 'Liverpool Reviews and Implementation Group, University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Jowett', 'Affiliation': 'Health Economics Unit, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Harbinder', 'Initials': 'H', 'LastName': 'Sandhu', 'Affiliation': 'Warwick Medical School, University of Warwick, Warwick, UK.'}, {'ForeName': 'Raymond', 'Initials': 'R', 'LastName': 'Chadwick', 'Affiliation': 'School of Health and Social Care, Teesside University, Middlesbrough, UK.'}, {'ForeName': 'Morag', 'Initials': 'M', 'LastName': 'Brookes', 'Affiliation': 'Department of Pain Medicine, The James Cook University Hospital, Middlesbrough, UK.'}, {'ForeName': 'Anu', 'Initials': 'A', 'LastName': 'Kansal', 'Affiliation': 'Department of Pain Medicine, The James Cook University Hospital, Middlesbrough, UK.'}, {'ForeName': 'Jenny', 'Initials': 'J', 'LastName': 'Earle', 'Affiliation': 'Patient and Public Involvement Representatives, Middlesbrough, UK.'}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Bell', 'Affiliation': 'Patient and Public Involvement Representatives, Middlesbrough, UK.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Robinson', 'Affiliation': 'Department of Pain Medicine, The James Cook University Hospital, Middlesbrough, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Walker', 'Affiliation': 'Exeter Clinical Trials Unit, College of Medicine and Health, University of Exeter, Exeter, UK.'}, {'ForeName': 'Shelley', 'Initials': 'S', 'LastName': 'Rhodes', 'Affiliation': 'Exeter Clinical Trials Unit, College of Medicine and Health, University of Exeter, Exeter, UK.'}, {'ForeName': 'Rod S', 'Initials': 'RS', 'LastName': 'Taylor', 'Affiliation': 'Exeter Clinical Trials Unit, College of Medicine and Health, University of Exeter, Exeter, UK.'}]",Pain,['10.1097/j.pain.0000000000001977'] 2826,32618884,Heart failure and renal outcomes according to baseline and achieved blood pressure in patients with type 2 diabetes: results from EMPA-REG OUTCOME.,"BACKGROUND The sodium-glucose co-transporter 2 (SGLT2) inhibitor empagliflozin reduced cardiovascular death or heart failure hospitalizations in type 2 diabetes (T2D) in addition to a reduction of SBP. As heart failure patients often present with low SBP, which can challenge treatment initiation, we explored if empagliflozin's effect on SBP was independent of baseline SBP and heart failure status, and if the effect on cardiovascular and heart failure outcomes was influenced by updated mean SBP or by an early change in SBP after drug initiation. METHODS AND RESULTS A total of 7020 patients were treated with empagliflozin 10 mg, 25 mg or placebo and followed for a median of 3.1 years. All of them had BP measurement at baseline. We evaluated changes in SBP in the context of heart failure status at baseline and according to baseline SBP categories (<120, 120--<130, 130--<140, 140--<160, ≥160 mmHg). The updated mean SBP during the trial was calculated as a time-dependent variable. We then assessed the association of baseline and updated mean SBP with three-point major adverse cardiovascular events (3P-MACE), hospitalization for heart failure, cardiovascular death, hospitalization for heart failure or cardiovascular death, all-cause death, and incident/worsening nephropathy, and whether treatment effect of empagliflozin vs. placebo on these outcomes differed if adjusted for updated mean SBP. Finally, we evaluated the impact of early decline in SBP (≥5 mmHg at week 4) on the treatment effect of empagliflozin vs. placebo on these outcomes. Analyses were performed via Cox regression adjusting for baseline risk factors including a term for treatment subgroup interaction, and by landmark analyses starting at week 4. The difference in SBP reduction at week 12 between empagliflozin and placebo was 3--5 mmHg and similar regardless of baseline SBP category or HF status at baseline. Baseline SBP and updated mean SBP categories showed no association with cardiovascular outcomes, but was associated with new/worsening nephropathy. The treatment effects of empagliflozin on all explored outcomes were independent of updated mean SBP as well of the early drop in SBP on treatment. CONCLUSION In addition to decreasing SBP, empagliflozin reduced cardiovascular, heart failure and renal outcomes independently of updated mean SBP during the trial, and of the early SBP drop. These results suggest a BP-independent effect of empagliflozin on cardiovascular and heart failure outcomes. CLINICALTRIALS. GOV IDENTIFIER NCT01131676.",2020,"In addition to decreasing SBP, empagliflozin reduced cardiovascular, heart failure and renal outcomes independently of updated mean SBP during the trial, and of the early SBP drop.","['7020 patients', 'patients with type 2 diabetes']","['empagliflozin', 'empagliflozin vs. placebo', 'sodium-glucose co-transporter 2 (SGLT2) inhibitor empagliflozin', 'empagliflozin 10\u200amg, 25\u200amg or placebo', 'placebo']","['Heart failure and renal outcomes', 'SBP, empagliflozin reduced cardiovascular, heart failure and renal outcomes', 'blood pressure', 'cardiovascular and heart failure outcomes', 'cardiovascular death or heart failure hospitalizations', 'adverse cardiovascular events (3P-MACE), hospitalization for heart failure, cardiovascular death, hospitalization for heart failure or cardiovascular death, all-cause death, and incident/worsening nephropathy', 'SBP reduction']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C3490348', 'cui_str': 'empagliflozin'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0037473', 'cui_str': 'Sodium'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0598849', 'cui_str': 'Co-Transporters'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C3848773', 'cui_str': 'empagliflozin 10 MG [Jardiance]'}]","[{'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0085805', 'cui_str': 'Androgen Binding Protein'}, {'cui': 'C3490348', 'cui_str': 'empagliflozin'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0286421', 'cui_str': 'ACE protocol 2'}, {'cui': 'C0332271', 'cui_str': 'Worsening'}, {'cui': 'C0022658', 'cui_str': 'Kidney disease'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",7020.0,0.0734859,"In addition to decreasing SBP, empagliflozin reduced cardiovascular, heart failure and renal outcomes independently of updated mean SBP during the trial, and of the early SBP drop.","[{'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Böhm', 'Affiliation': 'Klinik für Innere Medizin III, Saarland University Medical Center, Homburg/Saar, Germany.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Fitchett', 'Affiliation': ""St. Michael's Hospital, Division of Cardiology, University of Toronto, Toronto, Ontario, Canada.""}, {'ForeName': 'Anne Pernille', 'Initials': 'AP', 'LastName': 'Ofstad', 'Affiliation': 'Medical Department, Boehringer Ingelheim Ks, Asker, Norway.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Brueckmann', 'Affiliation': 'Boehringer Ingelheim International GmbH & Co KG, Ingelheim.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Kaspers', 'Affiliation': 'Boehringer Ingelheim International GmbH & Co KG, Ingelheim.'}, {'ForeName': 'Jyothis T', 'Initials': 'JT', 'LastName': 'George', 'Affiliation': 'Boehringer Ingelheim International GmbH & Co KG, Ingelheim.'}, {'ForeName': 'Isabella', 'Initials': 'I', 'LastName': 'Zwiener', 'Affiliation': 'Boehringer Ingelheim Pharma GmbH & Co KG, Ingelheim, Germany.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Zinman', 'Affiliation': 'Lunenfeld-Tanenbaum Research Institute, Mount Sinai Hospital, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Wanner', 'Affiliation': 'Department of Medicine, Wuerzburg University Clinic, Wuerzburg.'}, {'ForeName': 'Nikolaus', 'Initials': 'N', 'LastName': 'Marx', 'Affiliation': 'Department of Internal Medicine I, Cardiology, University Hospital Aachen, RWTH Aachen University Aachen, Germany.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Mancia', 'Affiliation': 'Clinica Medica, University of Milano-Bicocca, Ospedale San Gerardo, Monza, Italy.'}, {'ForeName': 'Stefan D', 'Initials': 'SD', 'LastName': 'Anker', 'Affiliation': 'Department of Cardiology (CVK) and Berlin Institute of Health Center for Regenerative Therapies (BCRT).'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Mahfoud', 'Affiliation': 'Klinik für Innere Medizin III, Saarland University Medical Center, Homburg/Saar, Germany.'}]",Journal of hypertension,['10.1097/HJH.0000000000002492'] 2827,32618958,Lessons Learned About Peristomal Skin Complications: Secondary Analysis of the ADVOCATE Trial.,"PURPOSE The aims of this study were to (1) describe the demographic and clinical characteristics of the individuals with peristomal skin complications (PSCs); (2) describe the PSCs; (3) examine the relationship of PSC occurrence and severity with possible risk factors, and (4) describe how PSCs were managed clinically. DESIGN Secondary analysis of data from randomized controlled study, the ADVOCATE trial. SUBJECTS AND SETTING Study participants (n = 153) were divided into 2 groups: those who did not experience a PSC (n = 80) and those who did (n = 73). A participant was considered to have sustained a PSC during the original study if his or her Discoloration, Erosion, and Tissue score increased above the baseline score. METHODS Demographic and pertinent characteristics of participants with and without PSCs were compared. In addition, data from the 73 participants who sustained PSCs were further analyzed to characterize and describe the PSCs, to investigate potential risk factors associated with the occurrence and severity of a PSC, and for clinical management. Group comparisons were made via t tests for continuous variables, χ test or Fisher exact test for categorical variables, and generalized linear models for identification of risk factors. RESULTS The majority of the PSCs were mild or moderate in nature, and they were most commonly categorized by the investigators as irritant dermatitis. Two risk factors were associated with an increased likelihood of experiencing a PSC: stoma duration and peristomal skinfold or creases. Within the study period, the odds of sustaining a PSC increased over time and the presence of skinfolds or creases increased the likelihood of PSCs. Peristomal skin complication severity was likely to be worse with an ileostomy and less severe as stoma duration increased. Products used to manage PSCs consisted of barrier rings/seals, skin barrier powder, and paste or paste strips. CONCLUSIONS Ileostomy is associated with higher risk of a severe PSC and peristomal skin creases or folds. Patient follow-up should be on a structured schedule beyond the first few weeks after surgery because the likelihood of getting a PSC increases over time. This approach may help improve outcomes, particularly for those with an ileostomy and challenging skin contours.",2020,Two risk factors were associated with an increased likelihood of experiencing a PSC: stoma duration and peristomal skinfold or creases.,"['Demographic and pertinent characteristics of participants with and without PSCs', 'Study participants (n = 153) were divided into 2 groups: those who did not experience a PSC (n = 80) and those who did (n = 73', '73 participants who sustained PSCs', 'individuals with peristomal skin complications (PSCs', 'Peristomal Skin Complications']",[],"['likelihood of experiencing a PSC: stoma duration and peristomal skinfold or creases', 'Peristomal skin complication severity']","[{'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0341600', 'cui_str': 'Peristomal skin complication'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0566602', 'cui_str': 'Primary sclerosing cholangitis'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C0027361', 'cui_str': 'Person'}]",[],"[{'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0566602', 'cui_str': 'Primary sclerosing cholangitis'}, {'cui': 'C1955856', 'cui_str': 'Stoma site'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0341600', 'cui_str': 'Peristomal skin complication'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",153.0,0.0347601,Two risk factors were associated with an increased likelihood of experiencing a PSC: stoma duration and peristomal skinfold or creases.,"[{'ForeName': 'Ginger', 'Initials': 'G', 'LastName': 'Salvadalena', 'Affiliation': 'Ginger Salvadalena, PhD, RN, CWOCN, Global Clinical Affairs, Hollister Incorporated, Libertyville, Illinois. Janice C. Colwell, MS, RN, CWOCN, FAAN, University of Chicago Medicine, Chicago, Illinois. George Skountrianos, MS, Global Clinical Affairs, Hollister Incorporated, Libertyville, Illinois. Joyce Pittman, PhD, RN, ANP-BC, FNP-BC, CWOCN, FAAN, College of Nursing, University of South Alabama Health Sciences, Mobile, Alabama.'}, {'ForeName': 'Janice C', 'Initials': 'JC', 'LastName': 'Colwell', 'Affiliation': ''}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Skountrianos', 'Affiliation': ''}, {'ForeName': 'Joyce', 'Initials': 'J', 'LastName': 'Pittman', 'Affiliation': ''}]","Journal of wound, ostomy, and continence nursing : official publication of The Wound, Ostomy and Continence Nurses Society",['10.1097/WON.0000000000000666'] 2828,32619032,Designing a multi-component intervention (P3-MumBubVax) to promote vaccination in antenatal care in Australia.,"Issue addressed Coverage of maternal influenza and pertussis vaccines remains suboptimal in Australia, and pockets of low childhood vaccine coverage persist nationwide. Maternal vaccine uptake is estimated to be between 35% and 60% for influenza vaccination and between 65% and 80% for pertussis vaccination. Australian midwives are highly trusted and ideally-placed to discuss vaccines with expectant parents, but there are no evidence-based interventions to optimise these discussions and promote maternal and childhood vaccine acceptance in the Australian public antenatal setting. METHODS We gathered qualitative data from Australian midwives, reviewed theoretical models, and adapted existing vaccine communication tools to develop the multi-component P3-MumBubVax intervention. Through 12 interviews at two Australian hospitals, we explored midwives' vaccination attitudes and values, perceived role in vaccine advocacy and delivery, and barriers and enablers to intervention implementation. Applying the theory-based P3 intervention model, we designed intervention components targeting the Practice, Provider and Parent levels. Midwives provided feedback on prototype intervention features through two focus groups. RESULTS The P3-MumBubVax intervention includes practice-level prompts and identification of a vaccine champion. Provider-level components are a vaccine communication training module, learning exercise, and website with printable fact sheets. Parent-level intervention components include text message reminders to receive influenza and pertussis vaccines in pregnancy, as well as online information on vaccine safety, effectiveness and disease severity. CONCLUSIONS The P3-MumBubVax intervention is the first Australian antenatal intervention designed to support both maternal and childhood vaccine uptake. A pilot study is underway to inform a planned cluster randomised controlled trial. So what? Barriers to vaccine acceptance and uptake are complex. The P3 model is a promising evidence-informed multi-component intervention strategy targeting all three levels influencing healthcare decision-making.",2020,The P3-MumBubVax intervention is the first Australian antenatal intervention designed to support both maternal and childhood vaccine uptake.,['antenatal care in Australia'],"['multi-component intervention (P3-MumBubVax', 'P3-MumBubVax intervention']","['Maternal vaccine uptake', 'vaccine safety, effectiveness and disease severity']","[{'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0004340', 'cui_str': 'Australia'}]","[{'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",,0.0735001,The P3-MumBubVax intervention is the first Australian antenatal intervention designed to support both maternal and childhood vaccine uptake.,"[{'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Kaufman', 'Affiliation': ""Murdoch Children's Research Institute, Parkville, Australia.""}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Attwell', 'Affiliation': 'School of Social Sciences, University of Western Australia, Perth, Australia.'}, {'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'Hauck', 'Affiliation': 'School of Nursing, Curtin University, Midwifery & Paramedicine, Perth, Australia.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Leask', 'Affiliation': 'Faculty of Medicine and Health, University of Sydney, Sydney, Australia.'}, {'ForeName': 'Saad B', 'Initials': 'SB', 'LastName': 'Omer', 'Affiliation': 'Rollins School of Public Health, Emory University, Atlanta, USA.'}, {'ForeName': 'Annette', 'Initials': 'A', 'LastName': 'Regan', 'Affiliation': 'School of Public Health, Texas A&M University, College Station, USA.'}, {'ForeName': 'Margie', 'Initials': 'M', 'LastName': 'Danchin', 'Affiliation': ""Murdoch Children's Research Institute, Parkville, Australia.""}]",Health promotion journal of Australia : official journal of Australian Association of Health Promotion Professionals,['10.1002/hpja.382'] 2829,32619050,Super-mini Percutaneous Nephrolithotomy (SMP) vs Standard Percutaneous Nephrolithotomy (sPNL) for the management of renal calculi < 2 cm: a randomized controlled study.,"OBJECTIVE To compare efficacy and safety between standard and super-mini PNL (SMP). PATIENTS & METHODS 150 patients presenting with renal calculi < 2 cm were randomized to standard (group 1) or SMP group (group 2). Randomization was based on centralized computer-generated numbers. Variables studied included stone free rates, operating time, intra-operative and postoperative complications, postoperative pain score, analgesic requirement and hospital stay. Statistical analysis was performed using t-test or Mann-Whitney U-test for continuous variables and chi-squared test or Fisher's exact test for categorical variables. RESULTS Between September 2018 and April 2019, 75 patients were included in each group. The stone free rates in both groups were similar (97.33 vs 98.66%, p = 0.56). Mean [SD] operating time (minutes) was significantly higher in group 2 (36.40 [14.07] vs 23.12 [11.96], p < 0.0001). Mean [SD] decrease in hemoglobin (gm/dl) was significantly less in group 2 (0.30 [0.49] vs 0.75 [0.65] p < 0.0001). Mean [SD] pain score at 24 h was significantly lower in group 2 (0.3 [0.46] vs 0.75 [0.53], p < 0.0001). Mean [SD] analgesic requirement (mg tramadol) was significantly less in group 2 (67 [22.49] vs 91.5 [30.56], p < 0.0001). Mean [SD] hospital stay (hours) was significantly less in group 2 (28.38 [3.6] vs 39.84 [3.7], p < 0.0001). CONCLUSIONS SMP is equally effective as standard PNL for managing renal calculi < 2cm at improved safety. Although SMP is associated with longer operative time, it has significantly lower incidence of bleeding, postoperative pain score and lesser hospital stay.",2020,"The stone free rates in both groups were similar (97.33 vs 98.66%, p = 0.56).","['75 patients were included in each group', 'Between September 2018 and April 2019', 'renal calculi < 2 cm', '150 patients presenting with renal calculi < 2 cm']","['Super-mini Percutaneous Nephrolithotomy (SMP) vs Standard Percutaneous Nephrolithotomy (sPNL', 'SMP', 'standard and super-mini PNL (SMP']","['stone free rates, operating time, intra-operative and postoperative complications, postoperative pain score, analgesic requirement and hospital stay', 'stone free rates', 'efficacy and safety', 'Mean [SD] decrease in hemoglobin', 'Mean [SD] pain score', 'bleeding, postoperative pain score and lesser hospital stay', 'Mean [SD] operating time (minutes', 'Mean [SD] hospital stay (hours', 'Mean [SD] analgesic requirement (mg tramadol']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0022650', 'cui_str': 'Kidney stone'}, {'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0150312', 'cui_str': 'Present'}]","[{'cui': 'C0445542', 'cui_str': 'Mini'}, {'cui': 'C0162428', 'cui_str': 'Removal of calculus of renal pelvis through percutaneous nephrostomy'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0006736', 'cui_str': 'Calculus'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0032787', 'cui_str': 'Postoperative complication'}, {'cui': 'C0030201', 'cui_str': 'Postoperative pain'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0162119', 'cui_str': 'Hemoglobin low'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0439227', 'cui_str': 'hour'}, {'cui': 'C0040610', 'cui_str': 'Tramadol'}]",75.0,0.0697676,"The stone free rates in both groups were similar (97.33 vs 98.66%, p = 0.56).","[{'ForeName': 'G', 'Initials': 'G', 'LastName': 'Raja Sekhar', 'Affiliation': 'Department of Urology, Kasturba Hospital, Manipal, MAHE, India.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Hegde', 'Affiliation': 'Department of Urology, Kasturba Hospital, Manipal, MAHE, India.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Chawla', 'Affiliation': 'Department of Urology, Kasturba Hospital, Manipal, MAHE, India.'}, {'ForeName': 'Jjmch', 'Initials': 'J', 'LastName': 'de la Rosette', 'Affiliation': 'Department of Urology, Istanbul Medipol University, Istanbul, Turkey.'}, {'ForeName': 'M P', 'Initials': 'MP', 'LastName': 'Laguna Pes', 'Affiliation': 'Department of Urology, Istanbul Medipol University, Istanbul, Turkey.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Aseem', 'Affiliation': 'Department of Urology, Kasturba Hospital, Manipal, MAHE, India.'}]",BJU international,['10.1111/bju.15144'] 2830,32611224,Process evaluation of the Cancer Home-Life Intervention: What can we learn from it for future intervention studies?,"BACKGROUND The Cancer Home-Life Intervention showed no significant effects, and examination of the processes affecting or inhibiting outcomes is relevant. AIM To evaluate the Cancer Home-Life Intervention for its processes of implementation, mechanisms of impact and contextual factors. DESIGN Process evaluation conducted alongside the randomised controlled trial, using quantitative and qualitative methods (ClinicalTrials.gov NCT02356627). The Cancer Home-Life Intervention is a tailored, occupational therapy-based programme. SETTING/PARTICIPANTS This study took place in participants' homes and at hospital. A total of 113 home-dwelling adults (⩾18 years) with advanced cancer who had received the Cancer Home-Life Intervention were included, together with five intervention-therapists. RESULTS All 113 participants (100%) received a first home visit; 32 participants (26%) received a second visit; and 4 participants (3%) received a third visit. Median number of delivered intervention components were 3 (interquartile range: 2; 4). Identified barriers for effect included unclear decision process for intervention dosage; participants' low expectations; participants' lack of energy; and insufficient time to adopt new strategies. The trial design constituted a barrier as the intervention could only be provided within a specific short period of time and not when relevant. Intervention components working to solve practical everyday problems, enhance enjoyment and increase a sense of safety were perceived as useful. CONCLUSION Future interventions can benefit from inclusion criteria closely related to the intervention focus and clear procedures for when to continue, follow-up and terminate intervention. Decisions about dose and timing may benefit from learning theory by taking into account the time and practice needed to acquire new skills.",2020,"BACKGROUND The Cancer Home-Life Intervention showed no significant effects, and examination of the processes affecting or inhibiting outcomes is relevant. ","[""participants' homes and at hospital"", '113 home-dwelling adults (⩾18\u2009years) with advanced cancer who had received the Cancer Home-Life Intervention were included, together with five intervention-therapists']",['Cancer Home-Life Intervention'],['Median number of delivered intervention components'],"[{'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0449432', 'cui_str': 'Component'}]",113.0,0.0682798,"BACKGROUND The Cancer Home-Life Intervention showed no significant effects, and examination of the processes affecting or inhibiting outcomes is relevant. ","[{'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'la Cour', 'Affiliation': 'REHPA, The Danish Knowledge Centre for Rehabilitation and Palliative Care, Odense University Hospital and University of Southern Denmark, Nyborg, Denmark.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Gregersen Oestergaard', 'Affiliation': 'DEFACTUM, Central Denmark Region, Aarhus, Denmark.'}, {'ForeName': 'Åse', 'Initials': 'Å', 'LastName': 'Brandt', 'Affiliation': 'The Research Initiative of Activity Studies and Occupational Therapy, Research Unit of General Practice, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Sara Marie Hebsgaard', 'Initials': 'SMH', 'LastName': 'Offersen', 'Affiliation': 'Research Unit for General Practice, Research Centre for Cancer Diagnosis in Primary Care, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Line', 'Initials': 'L', 'LastName': 'Lindahl-Jacobsen', 'Affiliation': 'The Research Initiative of Activity Studies and Occupational Therapy, Research Unit of General Practice, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Malcolm', 'Initials': 'M', 'LastName': 'Cutchin', 'Affiliation': 'Department of Health Care Sciences, Wayne State University, Detroit, MI, USA.'}, {'ForeName': 'Marc Sampedro', 'Initials': 'MS', 'LastName': 'Pilegaard', 'Affiliation': 'REHPA, The Danish Knowledge Centre for Rehabilitation and Palliative Care, Odense University Hospital and University of Southern Denmark, Nyborg, Denmark.'}]",Palliative medicine,['10.1177/0269216320939227'] 2831,32611242,Plant Stanol Esters Reduce LDL (Low-Density Lipoprotein) Aggregation by Altering LDL Surface Lipids: The BLOOD FLOW Randomized Intervention Study.,"OBJECTIVE Plant stanol ester supplementation (2-3 g plant stanols/d) reduces plasma LDL (low-density lipoprotein) cholesterol concentration by 9% to 12% and is, therefore, recommended as part of prevention and treatment of atherosclerotic cardiovascular disease. In addition to plasma LDL-cholesterol concentration, also qualitative properties of LDL particles can influence atherogenesis. However, the effect of plant stanol ester consumption on the proatherogenic properties of LDL has not been studied. Approach and Results: Study subjects (n=90) were randomized to consume either a plant stanol ester-enriched spread (3.0 g plant stanols/d) or the same spread without added plant stanol esters for 6 months. Blood samples were taken at baseline and after the intervention. The aggregation susceptibility of LDL particles was analyzed by inducing aggregation of isolated LDL and following aggregate formation. LDL lipidome was determined by mass spectrometry. Binding of serum lipoproteins to proteoglycans was measured using a microtiter well-based assay. LDL aggregation susceptibility was decreased in the plant stanol ester group, and the median aggregate size after incubation for 2 hours decreased from 1490 to 620 nm, P =0.001. Plant stanol ester-induced decrease in LDL aggregation was more extensive in participants having body mass index<25 kg/m 2 . Decreased LDL aggregation susceptibility was associated with decreased proportion of LDL-sphingomyelins and increased proportion of LDL-triacylglycerols. LDL binding to proteoglycans was decreased in the plant stanol ester group, the decrease depending on decreased serum LDL-cholesterol concentration. CONCLUSIONS Consumption of plant stanol esters decreases the aggregation susceptibility of LDL particles by modifying LDL lipidome. The resulting improvement of LDL quality may be beneficial for cardiovascular health. REGISTRATION URL: https://www.clinicaltrials.gov. Unique identifier: NCT01315964.",2020,"LDL aggregation susceptibility was decreased in the plant stanol ester group, and the median aggregate size after incubation for 2 hours decreased from 1490 to 620 nm, P =0.001.","['participants having body mass', 'Study subjects (n=90']","['plant stanol ester consumption', 'Plant stanol ester', 'Plant stanol ester supplementation', 'plant stanol ester-enriched spread (3.0 g plant stanols/d) or the same spread without added plant stanol esters', 'plant stanol esters', 'plant stanol ester', 'Plant Stanol Esters']","['plasma LDL (low-density lipoprotein) cholesterol concentration', 'LDL aggregation susceptibility', 'LDL aggregation', 'LDL binding to proteoglycans', 'Decreased LDL aggregation susceptibility', 'serum LDL-cholesterol concentration', 'LDL quality', 'proportion of LDL-triacylglycerols', 'aggregation susceptibility of LDL particles', 'median aggregate size']","[{'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0872973', 'cui_str': 'plant stanol ester'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0332261', 'cui_str': 'Spreading'}, {'cui': 'C0032098', 'cui_str': 'Kingdom Viridiplantae'}, {'cui': 'C0004269', 'cui_str': 'Child attention deficit disorder'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0023823', 'cui_str': 'Low density lipoprotein'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0332621', 'cui_str': 'Aggregation'}, {'cui': 'C0012655', 'cui_str': 'Diathesis'}, {'cui': 'C0332297', 'cui_str': 'Bounded by'}, {'cui': 'C0033692', 'cui_str': 'Proteoglycan'}, {'cui': 'C0853085', 'cui_str': 'Low density lipoprotein decreased'}, {'cui': 'C0428474', 'cui_str': 'Serum LDL cholesterol measurement'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0065191', 'cui_str': 'Low density lipoprotein triglyceride'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0205418', 'cui_str': 'Aggregate'}, {'cui': 'C0456389', 'cui_str': 'Size'}]",90.0,0.0510065,"LDL aggregation susceptibility was decreased in the plant stanol ester group, and the median aggregate size after incubation for 2 hours decreased from 1490 to 620 nm, P =0.001.","[{'ForeName': 'Maija', 'Initials': 'M', 'LastName': 'Ruuth', 'Affiliation': 'From the Atherosclerosis Research Laboratory, Wihuri Research Institute, Helsinki, Finland (M.R., L.A., F.T.-S., P.T.K., K.O.).'}, {'ForeName': 'Lauri', 'Initials': 'L', 'LastName': 'Äikäs', 'Affiliation': 'From the Atherosclerosis Research Laboratory, Wihuri Research Institute, Helsinki, Finland (M.R., L.A., F.T.-S., P.T.K., K.O.).'}, {'ForeName': 'Feven', 'Initials': 'F', 'LastName': 'Tigistu-Sahle', 'Affiliation': 'From the Atherosclerosis Research Laboratory, Wihuri Research Institute, Helsinki, Finland (M.R., L.A., F.T.-S., P.T.K., K.O.).'}, {'ForeName': 'Reijo', 'Initials': 'R', 'LastName': 'Käkelä', 'Affiliation': 'Molecular and Integrative Biosciences Research Programme, Faculty of Biological and Environmental Sciences, University of Helsinki, Finland (F.T.-S., R.K., K.O.).'}, {'ForeName': 'Harri', 'Initials': 'H', 'LastName': 'Lindholm', 'Affiliation': 'Finnish Institute of Occupational Health, Helsinki, Finland (H.L.).'}, {'ForeName': 'Piia', 'Initials': 'P', 'LastName': 'Simonen', 'Affiliation': 'Helsinki University Central Hospital, Heart and Lung Center, Cardiology, University of Helsinki, Finland (P.S., H.G.).'}, {'ForeName': 'Petri T', 'Initials': 'PT', 'LastName': 'Kovanen', 'Affiliation': 'From the Atherosclerosis Research Laboratory, Wihuri Research Institute, Helsinki, Finland (M.R., L.A., F.T.-S., P.T.K., K.O.).'}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Gylling', 'Affiliation': 'Helsinki University Central Hospital, Heart and Lung Center, Cardiology, University of Helsinki, Finland (P.S., H.G.).'}, {'ForeName': 'Katariina', 'Initials': 'K', 'LastName': 'Öörni', 'Affiliation': 'From the Atherosclerosis Research Laboratory, Wihuri Research Institute, Helsinki, Finland (M.R., L.A., F.T.-S., P.T.K., K.O.).'}]","Arteriosclerosis, thrombosis, and vascular biology",['10.1161/ATVBAHA.120.314329'] 2832,32611274,Infection after buried or exposed K-wire fixation of distal radial fractures: a randomized clinical trial.,"We treated 220 extra-articular distal radial fractures with closed reduction and percutaneous K-wire fixation and randomized K-wire placement to buried or exposed. We analysed the incidence and severity of infection and the mobility of the metacarpophalangeal joints. At 6 weeks postoperatively, 12 patients in the exposed group had infections versus two in the buried group, which was a statistically significant difference. Mobility was statistically but not clinically better in the buried group. One patient in each group had wires removed before fracture healing due to infection, which resulted in malunion. From this study we conclude that, in the treatment of distal radial fractures, it is better to bury the K-wires under the skin, especially when geographical conditions make it difficult to control the patients' adherence to hygiene and postoperative care despite the higher costs incurred with removal of buried K-wires. Level of evidence: II.",2020,Mobility was statistically but not clinically better in the buried group.,[],"['220 extra-articular distal radial fractures with closed reduction and percutaneous K-wire fixation and randomized K-wire placement to buried or exposed', 'buried or exposed K-wire fixation']","['Infection', 'Mobility']",[],"[{'cui': 'C4517650', 'cui_str': '220'}, {'cui': 'C0205135', 'cui_str': 'Extra-articular'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0034628', 'cui_str': 'Fracture of radius'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach'}, {'cui': 'C0086510', 'cui_str': 'K-wire'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0263398', 'cui_str': 'Erythema elevatum diutinum'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}]","[{'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0037426', 'cui_str': 'Social Mobility'}]",220.0,0.0357123,Mobility was statistically but not clinically better in the buried group.,"[{'ForeName': 'João Alberto R', 'Initials': 'JAR', 'LastName': 'Maradei-Pereira', 'Affiliation': 'Faculdade de Medicina, Universidade Federal do Pará, Belém, PA, Brazil.'}, {'ForeName': 'Amanda P', 'Initials': 'AP', 'LastName': 'Dos Santos', 'Affiliation': 'Faculdade de Medicina, Universidade Federal do Pará, Belém, PA, Brazil.'}, {'ForeName': 'Juliana R', 'Initials': 'JR', 'LastName': 'Martins', 'Affiliation': 'Faculdade de Medicina, Universidade Federal do Pará, Belém, PA, Brazil.'}, {'ForeName': 'Marcia R', 'Initials': 'MR', 'LastName': 'Maradei-Pereira', 'Affiliation': 'Hospital Maradei, Clínica dos Acidentados, Belém, PA, Brazil.'}]","The Journal of hand surgery, European volume",['10.1177/1753193420936543'] 2833,30933830,Cognitive functioning as a predictor of response to comprehensive cognitive remediation.,"Cognitive remediation is aimed at reducing cognitive impairments in severe mental illnesses such as schizophrenia, but little is known about whether severity of cognitive impairment predicts benefit from this intervention. To address this question, this study aggregated data from five randomized controlled trials (N = 300) of a standardized comprehensive, multimodal outpatient cognitive remediation program, the Thinking Skills for Work program, and evaluated whether baseline level of cognitive impairment differentially predicted improvement in cognitive functioning following cognitive remediation vs. usual services. Using standardized scores of neuropsychological functioning to designate ""low average,"" ""moderate,"" and ""severe"" levels of cognitive impairment, participants with greater cognitive impairment were found to benefit differentially more from cognitive remediation than usual services compared to less cognitively impaired participants. The findings were unaffected by statistically controlling for participant demographic and clinical characteristics. The findings suggest that individuals with the greatest cognitive impairment, for whom cognitive remediation was developed, are also most likely to benefit from this intervention.",2019,The findings were unaffected by statistically controlling for participant demographic and clinical characteristics.,[],"['standardized comprehensive, multimodal outpatient cognitive remediation program, the Thinking Skills for Work program']",['Cognitive functioning'],[],"[{'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C4277695', 'cui_str': 'Cognitive Remediation'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C4279942', 'cui_str': 'Thinking Skills'}, {'cui': 'C0043227', 'cui_str': 'Working'}]","[{'cui': 'C0392334', 'cui_str': 'Ability to perform cognitive activity'}]",,0.0778217,The findings were unaffected by statistically controlling for participant demographic and clinical characteristics.,"[{'ForeName': 'Nicole R', 'Initials': 'NR', 'LastName': 'DeTore', 'Affiliation': 'Department of Occupational Therapy, Boston University, Center for Psychiatric Rehabilitation, 940 Commonwealth Avenue, Boston, MA, 02215, USA. Electronic address: ndetore@bu.edu.'}, {'ForeName': 'Kim T', 'Initials': 'KT', 'LastName': 'Mueser', 'Affiliation': 'Department of Occupational Therapy, Boston University, Center for Psychiatric Rehabilitation, 940 Commonwealth Avenue, Boston, MA, 02215, USA. Electronic address: mueser@bu.edu.'}, {'ForeName': 'Jessica A', 'Initials': 'JA', 'LastName': 'Byrd', 'Affiliation': 'Department of Occupational Therapy, Boston University, Center for Psychiatric Rehabilitation, 940 Commonwealth Avenue, Boston, MA, 02215, USA. Electronic address: jbyrd95@bu.edu.'}, {'ForeName': 'Susan R', 'Initials': 'SR', 'LastName': 'McGurk', 'Affiliation': 'Department of Occupational Therapy, Boston University, Center for Psychiatric Rehabilitation, 940 Commonwealth Avenue, Boston, MA, 02215, USA. Electronic address: mcgurk@bu.edu.'}]",Journal of psychiatric research,['10.1016/j.jpsychires.2019.03.012'] 2834,30936377,Accuracy and Prognostic Significance of Oncologists' Estimates and Scenarios for Survival Time in Advanced Gastric Cancer.,"BACKGROUND Worst-case, typical, and best-case scenarios for survival, based on simple multiples of an individual's expected survival time (EST), estimated by their oncologist, are a useful way of formulating and explaining prognosis. We aimed to determine the accuracy and prognostic significance of oncologists' estimates of EST, and the accuracy of the resulting scenarios for survival time, in advanced gastric cancer. MATERIALS AND METHODS Sixty-six oncologists estimated the EST at baseline for each of the 152 participants they enrolled in the INTEGRATE trial. We hypothesized that oncologists' estimates of EST would be unbiased (∼50% would be longer or shorter than the observed survival time [OST]); imprecise (<33% within 0.67-1.33 times the OST); independently predictive of overall survival (OS); and accurate at deriving scenarios for survival time with approximately 10% of patients dying within a quarter of their EST (worst-case scenario), 50% living within half to double their EST (typical scenario), and 10% living three or more times their EST (best-case scenario). RESULTS Oncologists' estimates of EST were unbiased (45% were shorter than the OST, 55% were longer); imprecise (29% were within 0.67-1.33 times observed); moderately discriminative (Harrell's C-statistic 0.62, p = .001); and an independently significant predictor of OS (hazard ratio, 0.89; 95% confidence interval, 0.83-0.95; p = .001) in a Cox model including performance status, number of metastatic sites, neutrophil-to-lymphocyte ratio ≥3, treatment group, age, and health-related quality of life (EORTC-QLQC30 physical function score). Scenarios for survival time derived from oncologists' estimates were remarkably accurate: 9% of patients died within a quarter of their EST, 57% lived within half to double their EST, and 12% lived three times their EST or longer. CONCLUSION Oncologists' estimates of EST were unbiased, imprecise, moderately discriminative, and independently significant predictors of OS. Simple multiples of the EST accurately estimated worst-case, typical, and best-case scenarios for survival time in advanced gastric cancer. IMPLICATIONS FOR PRACTICE Results of this study demonstrate that oncologists' estimates of expected survival time for their patients with advanced gastric cancer were unbiased, imprecise, moderately discriminative, and independently significant predictors of overall survival. Simple multiples of the expected survival time accurately estimated worst-case, typical, and best-case scenarios for survival time in advanced gastric cancer.",2019,"Scenarios for survival time derived from oncologists' estimates were remarkably accurate: 9% of patients died within a quarter of their EST, 57% lived within half to double their EST, and 12% lived three times their EST or longer. ","['Sixty-six oncologists estimated the EST at baseline for each of the 152 participants they enrolled in the INTEGRATE trial', 'patients with advanced gastric cancer', 'advanced gastric cancer', 'Advanced Gastric Cancer']",[],"['overall survival (OS); and accurate at deriving scenarios for survival time', 'performance status, number of metastatic sites, neutrophil-to-lymphocyte ratio ≥3, treatment group, age, and health-related quality of life (EORTC-QLQC30 physical function score', 'survival time', 'overall survival', 'survival time (EST']","[{'cui': 'C4517841', 'cui_str': '66'}, {'cui': 'C0259990', 'cui_str': 'Oncologists'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C2919552', 'cui_str': 'Survival time'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0024623', 'cui_str': 'Malignant tumor of stomach'}]",[],"[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C2919552', 'cui_str': 'Survival time'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0027950', 'cui_str': 'Polymorphonuclear leukocyte'}, {'cui': 'C0024264', 'cui_str': 'Lymphocyte'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",152.0,0.0993891,"Scenarios for survival time derived from oncologists' estimates were remarkably accurate: 9% of patients died within a quarter of their EST, 57% lived within half to double their EST, and 12% lived three times their EST or longer. ","[{'ForeName': 'Anuradha', 'Initials': 'A', 'LastName': 'Vasista', 'Affiliation': 'NHMRC Clinical Trials Centre, University of Sydney, New South Wales, Australia anuradha.vasista@ctc.usyd.edu.au.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Stockler', 'Affiliation': 'NHMRC Clinical Trials Centre, University of Sydney, New South Wales, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Martin', 'Affiliation': 'NHMRC Clinical Trials Centre, University of Sydney, New South Wales, Australia.'}, {'ForeName': 'Nick', 'Initials': 'N', 'LastName': 'Pavlakis', 'Affiliation': 'Royal North Shore Hospital, New South Wales, Australia.'}, {'ForeName': 'Katrin', 'Initials': 'K', 'LastName': 'Sjoquist', 'Affiliation': 'NHMRC Clinical Trials Centre, University of Sydney, New South Wales, Australia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Goldstein', 'Affiliation': 'Prince of Wales Hospital, New South Wales, Australia.'}, {'ForeName': 'Sanjeev', 'Initials': 'S', 'LastName': 'Gill', 'Affiliation': 'The Alfred Hospital, Victoria, Australia.'}, {'ForeName': 'Vikram', 'Initials': 'V', 'LastName': 'Jain', 'Affiliation': 'ICON Cancer Foundation, Queensland, Australia.'}, {'ForeName': 'Geoffrey', 'Initials': 'G', 'LastName': 'Liu', 'Affiliation': 'University Health Network, Princess Margaret Hospital, Toronto, Canada.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Kannourakis', 'Affiliation': 'Ballarat Oncology and Haematology Services, Ballarat, Victoria, Australia.'}, {'ForeName': 'Yeul Hong', 'Initials': 'YH', 'LastName': 'Kim', 'Affiliation': 'Korea University Hospital, South Korea.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Nott', 'Affiliation': 'Royal Hobart Hospital, Tasmania, Australia.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Snow', 'Affiliation': 'Queen Elizabeth II Health Sciences Centre, Nova Scotia, Canada.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Burge', 'Affiliation': 'Royal Brisbane and Womens Hospital, Queensland, Australia.'}, {'ForeName': 'Dean', 'Initials': 'D', 'LastName': 'Harris', 'Affiliation': 'Christchurch Hospital, Canterbury, New Zealand.'}, {'ForeName': 'Derek', 'Initials': 'D', 'LastName': 'Jonker', 'Affiliation': 'Ottawa Health Research Institute, Ottawa, Canada.'}, {'ForeName': 'Yu Jo', 'Initials': 'YJ', 'LastName': 'Chua', 'Affiliation': 'Canberra Hospital, Australian Capital Territory, Australia.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Epstein', 'Affiliation': ""The Kinghorn Cancer Centre, St Vincent's Hospital, New South Wales, Australia.""}, {'ForeName': 'Antony', 'Initials': 'A', 'LastName': 'Bonaventura', 'Affiliation': 'Newcastle Private Hospital, New South Wales, Australia.'}, {'ForeName': 'Belinda', 'Initials': 'B', 'LastName': 'Kiely', 'Affiliation': 'NHMRC Clinical Trials Centre, University of Sydney, New South Wales, Australia.'}]",The oncologist,['10.1634/theoncologist.2018-0613'] 2835,30959227,Sex differences in the association of baseline c-reactive protein (CRP) and acute-phase treatment outcomes in major depressive disorder: Findings from the EMBARC study.,"Peripheral inflammation is associated with poor response to antidepressant treatments. However, whether sex differentially affects this association remains unknown. Participants of Establishing Moderators and Biosignatures of Antidepressant Response for Clinical Care (EMBARC) with baseline plasma samples were included in this study (n = 220; male n = 75, female n = 145). Depression severity [Hamilton Rating Scale for Depression 17-item (HAMD-17)] was measured at baseline and weeks- 1, 2, 3, 4, 6, and 8. Plasma c-reactive protein (CRP) was measured with commercially-available ELISA kits at baseline, week-1, and week-8. Sex difference in prediction of baseline-to-week-8 HAMD-17 change by baseline CRP was tested with sex-by-baseline-CRP-by-time interaction in mixed model analysis. Additionally, changes in CRP from baseline-to-week-8 CRP and its association with HAMD-17 changes over that period were also evaluated. Covariates included body mass index, site, smoking status, and age. There was a significant sex difference in association of baseline-to-week-8 HAMD-17 reduction with baseline CRP (p = 0.033). Higher baseline CRP was associated with lower baseline-to-week-8 HAMD-17 reduction in females (p < 0.0001) but not in males (p = 0.632). Additionally, CRP was significantly reduced (p = 0.041, effect size = 0.254) from baseline-to-week-8, but there were no sex differences in this reduction (p = 0.249). Baseline-to-week-8 changes in HAMD-17 and CRP were not significantly associated either overall (p = 0.348) or based on sex (p = 0.370). In a large study of depressed outpatients, we replicated previous findings that elevated baseline CRP levels are associated with worse antidepressant treatment outcomes. However, this effect was limited only to females. These findings emphasize the importance of studying sex differences in biological mechanisms linking inflammation and depression.",2019,"Additionally, CRP was significantly reduced (p = 0.041, effect size = 0.254) from baseline-to-week-8, but there were no sex differences in this reduction (p = 0.249).","['Participants of Establishing Moderators and Biosignatures of Antidepressant Response for Clinical Care (EMBARC) with baseline plasma samples were included in this study (n\u202f=\u202f220; male n\u202f=\u202f75, female n\u202f=\u202f145', 'major depressive disorder']",[],"['Plasma c-reactive protein (CRP', 'CRP', 'Higher baseline CRP', 'HAMD-17 and CRP', 'Depression severity [Hamilton Rating Scale for Depression 17-item (HAMD-17']","[{'cui': 'C0443211', 'cui_str': 'Established'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0444263', 'cui_str': 'Plasma specimen'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C4517650', 'cui_str': '220'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4517577', 'cui_str': '145'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}]",[],"[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",220.0,0.0344022,"Additionally, CRP was significantly reduced (p = 0.041, effect size = 0.254) from baseline-to-week-8, but there were no sex differences in this reduction (p = 0.249).","[{'ForeName': 'Manish K', 'Initials': 'MK', 'LastName': 'Jha', 'Affiliation': 'Center for Depression Research and Clinical Care, UT Southwestern Medical Center, 5323 Harry Hines Boulevard, Dallas, 75390-9119, TX, USA. Electronic address: manish.jha@mssm.edu.'}, {'ForeName': 'Abu', 'Initials': 'A', 'LastName': 'Minhajuddin', 'Affiliation': 'Center for Depression Research and Clinical Care, UT Southwestern Medical Center, 5323 Harry Hines Boulevard, Dallas, 75390-9119, TX, USA. Electronic address: Abu.Minhajuddin@utsouthwestern.edu.'}, {'ForeName': 'Cherise', 'Initials': 'C', 'LastName': 'Chin-Fatt', 'Affiliation': 'Center for Depression Research and Clinical Care, UT Southwestern Medical Center, 5323 Harry Hines Boulevard, Dallas, 75390-9119, TX, USA. Electronic address: Cherise.ChinFatt@utsouthwestern.edu.'}, {'ForeName': 'Tracy L', 'Initials': 'TL', 'LastName': 'Greer', 'Affiliation': 'Center for Depression Research and Clinical Care, UT Southwestern Medical Center, 5323 Harry Hines Boulevard, Dallas, 75390-9119, TX, USA. Electronic address: Tracy.Greer@utsouthwestern.edu.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Carmody', 'Affiliation': 'Center for Depression Research and Clinical Care, UT Southwestern Medical Center, 5323 Harry Hines Boulevard, Dallas, 75390-9119, TX, USA. Electronic address: Thomas.Carmody@utsouthwestern.edu.'}, {'ForeName': 'Madhukar H', 'Initials': 'MH', 'LastName': 'Trivedi', 'Affiliation': 'Center for Depression Research and Clinical Care, UT Southwestern Medical Center, 5323 Harry Hines Boulevard, Dallas, 75390-9119, TX, USA. Electronic address: Madhukar.Trivedi@utsouthwestern.edu.'}]",Journal of psychiatric research,['10.1016/j.jpsychires.2019.03.013'] 2836,31427720,The impact of complex karyotype on the overall survival of patients with relapsed chronic lymphocytic leukemia treated with idelalisib plus rituximab.,,2020,,['patients with relapsed chronic lymphocytic leukemia treated with'],"['idelalisib plus rituximab', 'complex karyotype']",['overall survival'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0023434', 'cui_str': 'Chronic lymphocytic leukemia'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C2698692', 'cui_str': 'idelalisib'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}, {'cui': 'C0056210', 'cui_str': 'complex V (mitochondrial oxidative phosphorylation system)'}, {'cui': 'C0022526', 'cui_str': 'Karyotype determination'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",,0.0533494,,"[{'ForeName': 'Karl-Anton', 'Initials': 'KA', 'LastName': 'Kreuzer', 'Affiliation': 'Department I of Internal Medicine, University of Cologne, Cologne, Germany. karl-anton.kreuzer@uni-koeln.de.'}, {'ForeName': 'Richard R', 'Initials': 'RR', 'LastName': 'Furman', 'Affiliation': 'Weill Cornell Medical College, New York, NY, USA.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Stilgenbauer', 'Affiliation': 'Department III of Internal Medicine, Ulm University Medical Center, Ulm, Germany.'}, {'ForeName': 'Ronald L', 'Initials': 'RL', 'LastName': 'Dubowy', 'Affiliation': 'Gilead Sciences, Inc., Foster City, CA, USA.'}, {'ForeName': 'Yeonhee', 'Initials': 'Y', 'LastName': 'Kim', 'Affiliation': 'Gilead Sciences, Inc., Foster City, CA, USA.'}, {'ForeName': 'Veerendra', 'Initials': 'V', 'LastName': 'Munugalavadla', 'Affiliation': 'Gilead Sciences, Inc., Foster City, CA, USA.'}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Lilienweiss', 'Affiliation': 'Department I of Internal Medicine, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Hans Christian', 'Initials': 'HC', 'LastName': 'Reinhardt', 'Affiliation': 'Department I of Internal Medicine, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Paula', 'Initials': 'P', 'LastName': 'Cramer', 'Affiliation': 'Department I of Internal Medicine, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Eichhorst', 'Affiliation': 'Department I of Internal Medicine, University of Cologne, Cologne, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Hillmen', 'Affiliation': ""St. James's University Hospital, Leeds, UK.""}, {'ForeName': 'Susan M', 'Initials': 'SM', 'LastName': ""O'Brien"", 'Affiliation': 'University of California-Irvine, Irvine Chao Family Comprehensive Cancer Center, Orange, CA, USA.'}, {'ForeName': 'Andrew R', 'Initials': 'AR', 'LastName': 'Pettitt', 'Affiliation': 'University of Liverpool, Liverpool, UK.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Hallek', 'Affiliation': 'Department I of Internal Medicine, University of Cologne, Cologne, Germany.'}]",Leukemia,['10.1038/s41375-019-0533-6'] 2837,31433542,Estimating plasma glucose with the FreeStyle Libre Pro continuous glucose monitor during oral glucose tolerance tests in youth without diabetes.,"Few studies have assessed the accuracy of the FreeStyle Libre Pro (FLP) continuous glucose monitor for estimating plasma glucose (PG) in non-diabetic children. OBJECTIVE Determine the accuracy of FLP compared to PG during OGTT in healthy children. SUBJECTS Children (7-11.99 years) with healthy weight and overweight/obesity (n = 33; 52% male). METHODS Participants wore the FLP before and during a 2-hour OGTT; PG was measured at 30 minutes intervals. Potential systematic- and magnitude-related biases for FLP vs PG were examined. RESULTS FLP 15-minute averages and PG were correlated at most timepoints during OGTT (r 2 = 0.35-0.69, P's < .001 for time point 30-120 minutes) and for PG area under the curve (AUC) (r 2 = 0.65, P < .0001). There were no systematic biases as assessed by Bland-Altman analyses for FLP AUC or for FLP at each OGTT timepoint. However, for fasting glucose, a significant magnitude bias was noted (r 2 = 0.38, P < .001), such that lower PG was underestimated, and higher PG was overestimated by FLP readings; further, there was poor correlation between fasting PG and FLP (r 2 = 0.06, P = .22). BMIz was also associated with FLP accuracy: FLP overestimated PG in children with low BMIz and underestimated PG in those with overweight/obesity for OGTT AUC and OGTT PG at baseline, 60, and 120 minutes (all P's ≤ .015). No adverse events occurred with FLP. CONCLUSIONS Among children without diabetes, the FLP was well tolerated and correlated with post-OGTT glucose, but had magnitude bias affecting fasting glucose and appeared to underestimate plasma glucose in those with overweight/obesity. These results suggest potential limitations for the utility of the FLP for research.",2019,"BMIz was also associated with FLP accuracy: FLP overestimated PG in children with low BMIz and underestimated PG in those with overweight/obesity for OGTT AUC and OGTT PG at baseline, 60, and 120 minutes (all P's ≤ .015).","['Children (7-11.99\u2009years) with healthy weight and overweight/obesity (n = 33; 52% male', 'youth without diabetes', 'healthy children']","['FreeStyle Libre Pro (FLP) continuous glucose monitor', 'FreeStyle Libre Pro continuous glucose monitor', 'FLP']","['adverse events', 'fasting PG and FLP', 'fasting glucose', 'PG area under the curve (AUC']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0686744', 'cui_str': 'Well child'}]","[{'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C4523945', 'cui_str': 'Continuous glucose monitoring'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}, {'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}]",,0.0344765,"BMIz was also associated with FLP accuracy: FLP overestimated PG in children with low BMIz and underestimated PG in those with overweight/obesity for OGTT AUC and OGTT PG at baseline, 60, and 120 minutes (all P's ≤ .015).","[{'ForeName': 'Nejla', 'Initials': 'N', 'LastName': 'Ghane', 'Affiliation': 'Section on Growth and Obesity, Division of Intramural Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institutes of Health (NIH), Bethesda, Maryland.'}, {'ForeName': 'Miranda M', 'Initials': 'MM', 'LastName': 'Broadney', 'Affiliation': 'Section on Growth and Obesity, Division of Intramural Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institutes of Health (NIH), Bethesda, Maryland.'}, {'ForeName': 'Elisabeth K', 'Initials': 'EK', 'LastName': 'Davis', 'Affiliation': 'Section on Growth and Obesity, Division of Intramural Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institutes of Health (NIH), Bethesda, Maryland.'}, {'ForeName': 'Robert W', 'Initials': 'RW', 'LastName': 'Trenschel', 'Affiliation': 'Section on Growth and Obesity, Division of Intramural Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institutes of Health (NIH), Bethesda, Maryland.'}, {'ForeName': 'Shavonne M', 'Initials': 'SM', 'LastName': 'Collins', 'Affiliation': 'Meharry Medical College, Nashville, Tennessee.'}, {'ForeName': 'Sheila M', 'Initials': 'SM', 'LastName': 'Brady', 'Affiliation': 'Section on Growth and Obesity, Division of Intramural Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institutes of Health (NIH), Bethesda, Maryland.'}, {'ForeName': 'Jack A', 'Initials': 'JA', 'LastName': 'Yanovski', 'Affiliation': 'Section on Growth and Obesity, Division of Intramural Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institutes of Health (NIH), Bethesda, Maryland.'}]",Pediatric diabetes,['10.1111/pedi.12910'] 2838,32614619,Rhinoplasty Photography: Lighting from Above Improves Visualization of Deviations and Irregularities.,"Importance: Standard lighting with two flashlight diffusors for pre- and postoperative photography deviates from typical natural lighting and may mask relevant irregularities and deviations of the nose due a decreased contrast. Objective: This study aimed at testing the hypothesis that lighting from above improves the depiction of irregularities and deviations of the nose. Design, Setting, and Participants: This was a prospective randomized controlled trial at an academic tertiary medical center. Forty consecutive rhinoplasty candidates who requested a correction of irregularities or deviations of the nose were photographed first with standard anterolateral lighting (two studio strobe lights and diffusor boxes) and second with lighting from above. Ten lay judges rated the degree of irregularity or deviation of the nose on cropped images of the anterior view of the nose with both lighting conditions on a 5-point Likert scale. Results: Ratings for deviation or irregularity of the nose were higher for the photograph taken with lighting from above in 30 (75%), equal in 3 (7.5%), and lower in 7 (17.5%) of 40 pairs of photographs. The mean rating of nasal deformity for lighting from above (2.47; confidence interval [CI] 95 : 2.22-2.72) was significantly higher than mean rating for anterolateral lighting (1.86; CI 95 : 1.61-2.11). Conclusions and Relevance: Photographic documentation for rhinoplasty may be improved by including lighting from above if the standard lighting fails to adequately depict nasal irregularities or deviations.",2020,The mean rating of nasal deformity for lighting from above (2.47; confidence interval [CI] 95 : 2.22-2.72) was significantly higher than mean rating for anterolateral lighting (1.86; CI 95 : 1.61-2.11). ,"['academic tertiary medical center', 'Forty consecutive rhinoplasty candidates who requested a correction of irregularities or deviations of the nose were photographed first with']","['standard anterolateral lighting (two studio strobe lights and diffusor boxes) and second with lighting from above', 'Rhinoplasty Photography']","['depiction of irregularities and deviations of the nose', 'Ratings for deviation or irregularity of the nose', 'mean rating of nasal deformity']","[{'cui': 'C0205372', 'cui_str': 'Tertiary'}, {'cui': 'C0565990', 'cui_str': 'Medical center'}, {'cui': 'C0035467', 'cui_str': 'Rhinoplasty'}, {'cui': 'C1272683', 'cui_str': 'Requested'}, {'cui': 'C0012727', 'cui_str': 'Displacement'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0441468', 'cui_str': 'Photograph'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0332194', 'cui_str': 'Anterolateral'}, {'cui': 'C0023693', 'cui_str': 'Light'}, {'cui': 'C0006080', 'cui_str': 'Boxing'}, {'cui': 'C0205436', 'cui_str': 'Second'}, {'cui': 'C0035467', 'cui_str': 'Rhinoplasty'}, {'cui': 'C0031749', 'cui_str': 'Photography'}]","[{'cui': 'C0012727', 'cui_str': 'Displacement'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0000768', 'cui_str': 'Congenital malformation'}]",,0.0599647,The mean rating of nasal deformity for lighting from above (2.47; confidence interval [CI] 95 : 2.22-2.72) was significantly higher than mean rating for anterolateral lighting (1.86; CI 95 : 1.61-2.11). ,"[{'ForeName': 'Abel-Jan', 'Initials': 'AJ', 'LastName': 'Tasman', 'Affiliation': 'ENT Department, Cantonal Hospital St. Gallen, St. Gallen, Switzerland.'}]",Facial plastic surgery & aesthetic medicine,['10.1089/fpsam.2020.0169'] 2839,32614625,First-time handling of different inhalers by chronic obstructive lung disease patients.,"Background: There is a lack of guidance on inhaler device selection and how to individualize inhaler choice when prescribed for the first-time. Aim of the work: To compare different inhalers regarding ease of use and number of counseling attempts needed for correct handling in subjects with a first experience to such inhalers; also, to investigate if there is a correlation between total correct steps achievements and patient demographics/clinical variables. Method: An open-label, non-drug interventional, cross-over study was conducted including 180 Egyptian patients with chronic obstructive pulmonary disease (COPD). The study evaluated handling of the most common inhalers in subjects with a first experience with them before hospital discharge. Subjects were randomized to handle 10 placebo inhalers including: [metered dose inhaler (pMDI), Aerolizer, Handihaler, Turbohaler, Diskus, Breezhaler, Ellipta, Easyhaler, Diskhaler, and Respimat] without receiving verbal or demonstrative instruction with allowable access to the patient information leaflets in native language supported by figures with enough time to read (baseline assessment). Subjects were then crossed-over to other inhalers with a first experience randomly. Inhalers with a reported past-experience were excluded. Inhaler-technique was assessed by using previously defined checklists, including essential steps and critical errors. The whole handling of the inhaler was demonstrated and the number of counseling attempts needed to correct handling was recorded. Patient demographics and clinical variables were recorded and correlated with correct handling steps. Results: The baseline percentages of total correct steps achievements as mean ± SD were 50 ± 19, 52 ± 16, 58 ± 14, 60 ± 17, 64 ± 10, 67 ± 16, 72 ± 17, 73 ± 11, 77 ± 14 and 86 ± 11% for Respimat, pMDI, Diskhaler, Diskus, Aerolizer, Handihaler, Easyhaler, Turbohaler, Breezhaler, and Ellipta respectively with p < 0.001. Baseline percentages of participants with at least 1 critical error significantly differed between inhalers (p < 0.05) with Ellipta showing the lowest percentage (37%). pMDI, Diskhaler, and Respimat showed the highest percentages (100%, 97% and 94% respectively). The number of counseling attempts needed to reach correct handling showed a significant difference among inhalers (p < 0.05). Ellipta showed the highest percentage of participants with correct handling with no counseling (20%) and the highest percentage of participants achieved with one counseling attempt (78%). Diskhaler, pMDI, and Respimat were the only inhalers included in a fourth counseling attempt (15%, 9%, and 6% respectively). Weak and very weak correlations were found between patient demographics/clinical variables and percentages of total correct steps achievements. Conclusion: Inhalers techniques greatly vary in their ease of use (self-explaining) ranging from easy inhalers (Ellipta) to intermediate inhalers (breezhaler, Easyhaler, Turbohaler, Aerolizer, Handihaler, and Diskus) followed by the most difficult inhalers (pMDI, Diskhaler, and Respimat). That must be considered when prescribing inhalers for the first time; choice of the inhaler should, in part, be based on ease of use and to be accompanied by repeated counseling.",2020,The number of counseling attempts needed to reach correct handling showed a significant difference among inhalers (p < 0.05).,"['chronic obstructive lung disease patients', 'subjects with a first experience with them before hospital discharge', 'subjects with a first experience to such inhalers', '180 Egyptian patients with chronic obstructive pulmonary disease (COPD']","['placebo inhalers including: [metered dose inhaler (pMDI), Aerolizer, Handihaler, Turbohaler, Diskus, Breezhaler, Ellipta, Easyhaler, Diskhaler, and Respimat] without receiving verbal or demonstrative instruction with allowable access to the patient information leaflets in native language supported by figures with enough time to read (baseline assessment']","['Diskhaler, pMDI, and Respimat']","[{'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0586003', 'cui_str': 'Discharge from hospital'}, {'cui': 'C0021461', 'cui_str': 'Inhaler'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0013717', 'cui_str': 'Egyptian language'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0021461', 'cui_str': 'Inhaler'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0993596', 'cui_str': 'Metered dose inhaler'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0079891', 'cui_str': 'Indigenous Population'}, {'cui': 'C0023008', 'cui_str': 'Language'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0034754', 'cui_str': 'Reading'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}]",[],180.0,0.0477912,The number of counseling attempts needed to reach correct handling showed a significant difference among inhalers (p < 0.05).,"[{'ForeName': 'Hadeer S', 'Initials': 'HS', 'LastName': 'Harb', 'Affiliation': 'Clinical Pharmacy Department, Faculty of Pharmacy, Beni-Suef University, Beni-Suef, Egypt.'}, {'ForeName': 'Nabila Ibrahim', 'Initials': 'NI', 'LastName': 'Laz', 'Affiliation': 'Department of Chest Diseases, Faculty of Medicine, Beni-Suef University, Beni-Suef, Egypt.'}, {'ForeName': 'Hoda', 'Initials': 'H', 'LastName': 'Rabea', 'Affiliation': 'Clinical Pharmacy Department, Faculty of Pharmacy, Beni-Suef University, Beni-Suef, Egypt.'}, {'ForeName': 'Mohamed E A', 'Initials': 'MEA', 'LastName': 'Abdelrahim', 'Affiliation': 'Clinical Pharmacy Department, Faculty of Pharmacy, Beni-Suef University, Beni-Suef, Egypt.'}]",Experimental lung research,['10.1080/01902148.2020.1789903'] 2840,32614699,"Teriparatide Promotes Bone Healing in Medication-Related Osteonecrosis of the Jaw: A Placebo-Controlled, Randomized Trial.","PURPOSE Medication-related osteonecrosis of the jaw (MRONJ) is an infrequent but morbid and potentially serious condition associated with antiresorptive and antiangiogenic therapies. Although MRONJ can be prevented by optimizing oral health, management of established cases is supportive and remains challenging. Teriparatide, an osteoanabolic agent that improves bone healing in preclinical studies and in chronic periodontitis, represents a potential treatment option. PATIENTS AND METHODS In a double-blind, randomized, controlled trial, 34 participants with established MRONJ, with a total of 47 distinct MRONJ lesions, were allocated to either 8 weeks of subcutaneous teriparatide (20 µg/day) or placebo injections, in addition to calcium and vitamin D supplementation and standard clinical care. Participants were observed for 12 months, with primary outcomes that included the clinical and radiologic resolution of MRONJ lesions. Secondary outcomes included osteoblastic responses as measured biochemically and radiologically and changes in quality of life. RESULTS Teriparatide was associated with a greater rate of resolution of MRONJ lesions (odds ratio [OR], 0.15 v 0.40; P = .013), and 45.4% of lesions resolved by 52 weeks compared with 33.3% in the placebo group. Teriparatide was also associated with reduced bony defects at week 52 (OR, 8.1; P = .017). The incidence of adverse events was balanced between groups, including nausea, anorexia, and musculoskeletal pain, most of mild severity. CONCLUSION Teriparatide improves the rate of resolution of MRONJ lesions and represents an efficacious and safe treatment for it.",2020,Teriparatide improves the rate of resolution of MRONJ lesions and represents an efficacious and safe treatment for it.,"['Medication-Related Osteonecrosis of the Jaw', '34 participants with established MRONJ, with a total of 47 distinct MRONJ lesions']","['Placebo', 'subcutaneous teriparatide', 'Teriparatide', 'placebo injections, in addition to calcium and vitamin D supplementation and standard clinical care', 'placebo']","['nausea, anorexia, and musculoskeletal pain, most of mild severity', 'rate of resolution of MRONJ lesions', 'reduced bony defects', 'clinical and radiologic resolution of MRONJ lesions', 'bone healing', 'osteoblastic responses as measured biochemically and radiologically and changes in quality of life', 'adverse events']","[{'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0029445', 'cui_str': 'Bone necrosis'}, {'cui': 'C0022359', 'cui_str': 'Jaw'}, {'cui': 'C0443211', 'cui_str': 'Established'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0443315', 'cui_str': 'Subcutaneous'}, {'cui': 'C0070093', 'cui_str': 'Teriparatide'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}]","[{'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0003123', 'cui_str': 'Anorexia'}, {'cui': 'C0026858', 'cui_str': 'Musculoskeletal pain'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0029445', 'cui_str': 'Bone necrosis'}, {'cui': 'C0022359', 'cui_str': 'Jaw'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0443157', 'cui_str': 'Bony'}, {'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0034599', 'cui_str': 'Radiology - specialty'}, {'cui': 'C1321023', 'cui_str': 'Bone healing status'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",34.0,0.409353,Teriparatide improves the rate of resolution of MRONJ lesions and represents an efficacious and safe treatment for it.,"[{'ForeName': 'Ie-Wen', 'Initials': 'IW', 'LastName': 'Sim', 'Affiliation': 'Melbourne Medical School, University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Gelsomina L', 'Initials': 'GL', 'LastName': 'Borromeo', 'Affiliation': 'Melbourne Dental School, University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Claudine', 'Initials': 'C', 'LastName': 'Tsao', 'Affiliation': 'Melbourne Dental School, University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Hardiman', 'Affiliation': 'Melbourne Dental School, University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Michael S', 'Initials': 'MS', 'LastName': 'Hofman', 'Affiliation': 'Cancer Imaging, Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Papatziamos Hjelle', 'Affiliation': ""School of Biomedical Engineering and Imaging Sciences, King's College London, London, United Kingdom.""}, {'ForeName': 'Musib', 'Initials': 'M', 'LastName': 'Siddique', 'Affiliation': ""School of Biomedical Engineering and Imaging Sciences, King's College London, London, United Kingdom.""}, {'ForeName': 'Gary J R', 'Initials': 'GJR', 'LastName': 'Cook', 'Affiliation': ""School of Biomedical Engineering and Imaging Sciences, King's College London, London, United Kingdom.""}, {'ForeName': 'John F', 'Initials': 'JF', 'LastName': 'Seymour', 'Affiliation': 'Melbourne Medical School, University of Melbourne, Melbourne, Victoria, Australia.'}, {'ForeName': 'Peter R', 'Initials': 'PR', 'LastName': 'Ebeling', 'Affiliation': 'Department of Medicine, School of Clinical Sciences, Monash University, Clayton, Victoria, Australia.'}]",Journal of clinical oncology : official journal of the American Society of Clinical Oncology,['10.1200/JCO.19.02192'] 2841,32614723,The Effect of a Rehabilitation Specific Gaming Software Platform to Achieve Individual Physiotherapy Goals in Children with Severe Spastic Cerebral Palsy: A Randomized Crossover Trial.,"Cerebral palsy (CP) is the most common cause of permanent neurological disabilities in children. Many children require long-term daily physiotherapy (PT), and videogaming is a promising tool to increase motivation in rehabilitation. The short- and medium-term effects of an intervention with rehabilitation specific videogames were evaluated on individually defined therapy goals, gross motor function, and motivation. Thirty-two children with bilateral spastic CP, Gross Motor Function Classification level III-IV, and 6-15 years were randomized into an intervention group (regular PT and gaming) or a control group (regular PT), followed by a crossover. The effects of both training periods (each 12 weeks) were compared using the Goal Attainment Scale (GAS), Trunk Control Measurement Scale (TCMS), Pediatric Balance Scale (PBS), Gross Motor Function Measure-88 (GMFM-88), and Dimensions of Mastery Motivation Questionnaire (DMQ). After 3 months follow-up, children were retested using the GMFM, TCMS, and PBS. The GAS change scores were significantly higher after the intervention compared to the control period (8.5 and 2.4, P  < 0.001). The change scores for standing exercises (3.85 and 0.22, P  = 0.04) and dynamic sitting balance (5.9 and -1.7, P  < 0.001) were also significantly higher. After 3 months follow-up the results did not persist. A combined approach of regular PT and rehabilitation specific gaming showed significant effects on individually defined therapy goals, dynamic sitting balance, and standing exercises. However, the lack of persistent effect indicates that continuous individual goal-oriented PT with the addition of gaming is needed.",2020,"The change scores for standing exercises (3.85 and 0.22, P  = 0.04) and dynamic sitting balance (5.9 and -1.7, P  < 0.001) were also significantly higher.","['permanent neurological disabilities in children', 'Thirty-two children with bilateral spastic CP, Gross Motor Function Classification level III-IV, and 6-15 years', 'Children with Severe Spastic Cerebral Palsy']","['Rehabilitation Specific Gaming Software Platform', 'intervention group (regular PT and gaming) or a control group (regular PT']","['Goal Attainment Scale (GAS), Trunk Control Measurement Scale (TCMS), Pediatric Balance Scale (PBS), Gross Motor Function Measure-88 (GMFM-88), and Dimensions of Mastery Motivation Questionnaire (DMQ', 'dynamic sitting balance', 'GAS change scores', 'therapy goals, dynamic sitting balance, and standing exercises', 'change scores for standing exercises']","[{'cui': 'C0205355', 'cui_str': 'Permanent'}, {'cui': 'C0205494', 'cui_str': 'Neurologic'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0450357', 'cui_str': '32'}, {'cui': 'C3838784', 'cui_str': 'Bilateral cerebral palsy'}, {'cui': 'C0677549', 'cui_str': 'Gross motor functions'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0441927', 'cui_str': 'Level III'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0338596', 'cui_str': 'Spastic cerebral palsy'}]","[{'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0037585', 'cui_str': 'Software'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205272', 'cui_str': 'Regular'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0426971', 'cui_str': 'Trunk control'}, {'cui': 'C0681887', 'cui_str': 'Measurement scales'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0677549', 'cui_str': 'Gross motor functions'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0516712', 'cui_str': 'Balancing when sitting'}, {'cui': 'C0017110', 'cui_str': 'Gas'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0231472', 'cui_str': 'Orthostatic body position'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]",32.0,0.0195884,"The change scores for standing exercises (3.85 and 0.22, P  = 0.04) and dynamic sitting balance (5.9 and -1.7, P  < 0.001) were also significantly higher.","[{'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Decavele', 'Affiliation': 'CP Reference Centre, University Hospital Leuven, Leuven, Belgium.'}, {'ForeName': 'Els', 'Initials': 'E', 'LastName': 'Ortibus', 'Affiliation': 'CP Reference Centre, University Hospital Leuven, Leuven, Belgium.'}, {'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'Van Campenhout', 'Affiliation': 'CP Reference Centre, University Hospital Leuven, Leuven, Belgium.'}, {'ForeName': 'Guy', 'Initials': 'G', 'LastName': 'Molenaers', 'Affiliation': 'CP Reference Centre, University Hospital Leuven, Leuven, Belgium.'}, {'ForeName': 'Bart', 'Initials': 'B', 'LastName': 'Jansen', 'Affiliation': 'Department of Electronics and Informatics, Vrije Universiteit Brussel, Brussels, Belgium.'}, {'ForeName': 'Lubos', 'Initials': 'L', 'LastName': 'Omelina', 'Affiliation': 'Department of Electronics and Informatics, Vrije Universiteit Brussel, Brussels, Belgium.'}, {'ForeName': 'Inge', 'Initials': 'I', 'LastName': 'Franki', 'Affiliation': 'CP Reference Centre, University Hospital Leuven, Leuven, Belgium.'}]",Games for health journal,['10.1089/g4h.2019.0097'] 2842,32615110,"Weekly platinum-based chemotherapy versus 3-weekly platinum-based chemotherapy for newly diagnosed ovarian cancer (ICON8): quality-of-life results of a phase 3, randomised, controlled trial.","BACKGROUND The ICON8 study reported no significant improvement in progression-free survival (a primary endpoint) with weekly chemotherapy compared with standard 3-weekly treatment among patients with epithelial ovarian cancer. All ICON8 patients were eligible to take part in the accompanying health-related quality-of-life study, which measured the effect of treatment on self-reported wellbeing, reported here. METHODS In this open-label, randomised, controlled, phase 3, three-arm, Gynecologic Cancer Intergroup (GCIG) trial done at 117 hospital sites in the UK, Australia, New Zealand, Mexico, South Korea, and Republic of Ireland, women (aged at least 18 years) with newly diagnosed, histologically confirmed International Federation of Gynecology and Obstetrics stage IC-IV ovarian cancer and an Eastern Cooperative Oncology Group performance status of 0-2 were randomly assigned (1:1:1) centrally using minimisation to group 1 (intravenous carboplatin area under the curve [AUC]5 or AUC6 and 175 mg/m 2 intravenous paclitaxel every 3 weeks), group 2 (carboplatin AUC5 or AUC6 every 3 weeks and 80 mg/m 2 paclitaxel weekly), or group 3 (carboplatin AUC2 weekly and 80 mg/m 2 paclitaxel weekly). Randomisation was stratified by GCIG group, disease stage, and outcome and timing of surgery. Patients and clinicians were not masked to treatment assignment. Patients underwent immediate or delayed primary surgery according to clinicians' choice. Patients were asked to complete European Organisation for Research and Treatment of Cancer QLQ-C30 and QLQ-OV28 questionnaires at enrolment, before each chemotherapy cycle, then 6-weekly up to 9 months, 3-monthly up to 2 years, and 6-monthly up to 5 years. Quality of life was a prespecified secondary outcome of the ICON8 study. Within the quality-of-life study, the co-primary endpoints were QLQ-C30 global health score at 9 months (cross-sectional analysis) and mean QLQ-C30 global health score from randomisation to 9 months (longitudinal analysis). Data analyses were done on an intention-to-treat basis. The trial is registered on ClinicalTrials.gov, NCT01654146 and ISRCTN Registry, ISRCTN10356387, and is currently in long-term follow up. FINDINGS Between June 6, 2011, and Nov 28, 2014, 1566 patients were recruited into ICON8 (522 were included in group 1, 523 in group 2, and 521 in group 3). Baseline quality-of-life questionnaires were completed by 1438 (92%) of 1566 patients and 9-month questionnaires by 882 (69%) of 1280 patients. We observed no significant difference in global health score at 9 months (cross-sectional analysis) between study groups (group 2 vs group 1, difference in mean score 2·3, 95% CI -0·4 to 4·9, p=0·095; group 3 vs group 1, -0·8, -3·8 to 2·2, p=0·61). Using longitudinal analysis, we found lower global health scores for those receiving weekly paclitaxel than for those receiving 3-weekly chemotherapy (group 2 vs group 1, mean difference -1·8, 95% CI -3·6 to -0·1, p=0·043; group 3 vs group 1, -2·9, -4·7 to -1·1, p=0·0018). INTERPRETATION We found no evidence of a difference in global quality of life between treatment groups at 9 months; however, patients receiving weekly treatment reported lower mean quality of life across the 9-month period after randomisation. Taken together with the lack of progression-free survival benefit, these findings do not support routine use of weekly paclitaxel-containing regimens in the management of newly diagnosed ovarian cancer. FUNDING Cancer Research UK, Medical Research Council, Health Research Board Ireland, Irish Cancer Society, and Cancer Australia.",2020,"Using longitudinal analysis, we found lower global health scores for those receiving weekly paclitaxel than for those receiving 3-weekly chemotherapy (group 2 vs group 1, mean difference -1·8, 95% CI -3·6 to -0·1, p=0·043; group 3 vs group 1, -2·9, -4·7 to -1·1, p=0·0018). ","['1566 patients and 9-month questionnaires by 882 (69%) of 1280 patients', 'newly diagnosed ovarian cancer (ICON8', 'newly diagnosed ovarian cancer', ""Patients underwent immediate or delayed primary surgery according to clinicians' choice"", 'patients with epithelial ovarian cancer', '117 hospital sites in the UK, Australia, New Zealand, Mexico, South Korea, and Republic of Ireland, women (aged at least 18 years) with newly diagnosed, histologically confirmed International Federation of Gynecology and Obstetrics stage IC-IV ovarian cancer and an Eastern Cooperative Oncology Group performance status of 0-2', 'Between June 6, 2011, and Nov 28, 2014, 1566 patients were recruited into ICON8 (522 were included in group 1, 523 in group 2, and 521 in group 3']","['Weekly platinum-based chemotherapy versus 3-weekly platinum-based chemotherapy', 'paclitaxel', 'minimisation to group 1 (intravenous carboplatin area under the curve [AUC]5 or AUC6 and 175 mg/m 2 intravenous paclitaxel every 3 weeks), group 2 (carboplatin AUC5 or AUC6 every 3 weeks and 80 mg/m 2 paclitaxel weekly), or group 3 (carboplatin AUC2 weekly and 80 mg/m 2 paclitaxel', 'paclitaxel-containing regimens', 'chemotherapy']","['global quality of life', 'global health scores', 'mean QLQ-C30 global health score', 'progression-free survival', 'Baseline quality-of-life questionnaires', 'mean quality of life', 'global health score', 'Quality of life', 'Cancer QLQ-C30 and QLQ-OV28 questionnaires', 'QLQ-C30 global health score']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0919267', 'cui_str': 'Neoplasm of ovary'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0008300', 'cui_str': 'Choice Behavior'}, {'cui': 'C4721610', 'cui_str': 'Epithelial Ovarian Carcinoma'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0027978', 'cui_str': 'New Zealand'}, {'cui': 'C0025885', 'cui_str': 'Mexico'}, {'cui': 'C0022773', 'cui_str': 'Republic of Korea'}, {'cui': 'C0022067', 'cui_str': 'Republic of Ireland'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0450454', 'cui_str': 'FIGO Stage'}, {'cui': 'C1520224', 'cui_str': 'ECOG performance status'}, {'cui': 'C0949920', 'cui_str': 'Norovirus'}, {'cui': 'C4517804', 'cui_str': '522'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}]","[{'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C3536920', 'cui_str': 'Platinum compounds'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}, {'cui': 'C4517605', 'cui_str': '175'}, {'cui': 'C0585333', 'cui_str': 'Triweekly'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C1456573', 'cui_str': 'Global Health'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}]",1566.0,0.232117,"Using longitudinal analysis, we found lower global health scores for those receiving weekly paclitaxel than for those receiving 3-weekly chemotherapy (group 2 vs group 1, mean difference -1·8, 95% CI -3·6 to -0·1, p=0·043; group 3 vs group 1, -2·9, -4·7 to -1·1, p=0·0018). ","[{'ForeName': 'Sarah P', 'Initials': 'SP', 'LastName': 'Blagden', 'Affiliation': 'Department of Oncology, University of Oxford, Oxford, UK. Electronic address: sarah.blagden@oncology.ox.ac.uk.'}, {'ForeName': 'Adrian D', 'Initials': 'AD', 'LastName': 'Cook', 'Affiliation': 'Medical Research Council Clinical Trials Unit, Institute of Clinical Trials and Methodology, University College London, London, UK.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Poole', 'Affiliation': 'Department of Oncology, University Hospital Coventry, Coventry, UK.'}, {'ForeName': 'Lesley', 'Initials': 'L', 'LastName': 'Howells', 'Affiliation': 'Maggie Keswick Jencks Cancer Caring Centres Trust, London, UK.'}, {'ForeName': 'Ian A', 'Initials': 'IA', 'LastName': 'McNeish', 'Affiliation': 'Ovarian Cancer Action Research Centre, Department of Surgery and Cancer, Imperial College London, London, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Dean', 'Affiliation': 'Oncology Department, St John of God Subiaco Hospital, Perth, WA, Australia.'}, {'ForeName': 'Jae-Weon', 'Initials': 'JW', 'LastName': 'Kim', 'Affiliation': 'Department of Obstetrics and Gynaecology, Seoul National University Hospital, Seoul, South Korea.'}, {'ForeName': 'Dearbhaile M', 'Initials': 'DM', 'LastName': ""O'Donnell"", 'Affiliation': 'Gynaecology Subgroup, Cancer Trials Ireland, Dublin, Ireland.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Hook', 'Affiliation': ""St James's University Hospital, Leeds, UK.""}, {'ForeName': 'Elizabeth C', 'Initials': 'EC', 'LastName': 'James', 'Affiliation': 'Medical Research Council Clinical Trials Unit, Institute of Clinical Trials and Methodology, University College London, London, UK.'}, {'ForeName': 'Ian R', 'Initials': 'IR', 'LastName': 'White', 'Affiliation': 'Medical Research Council Clinical Trials Unit, Institute of Clinical Trials and Methodology, University College London, London, UK.'}, {'ForeName': 'Timothy', 'Initials': 'T', 'LastName': 'Perren', 'Affiliation': ""St James's University Hospital, Leeds, UK.""}, {'ForeName': 'Rosemary', 'Initials': 'R', 'LastName': 'Lord', 'Affiliation': 'Department of Oncology, Clatterbridge Cancer Centre, Birkenhead, UK.'}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'Dark', 'Affiliation': 'Department of Oncology, Newcastle University, Newcastle, UK.'}, {'ForeName': 'Helena M', 'Initials': 'HM', 'LastName': 'Earl', 'Affiliation': 'NIHR Cambridge Biomedical Research Centre, Cambridge, UK.'}, {'ForeName': 'Marcia', 'Initials': 'M', 'LastName': 'Hall', 'Affiliation': 'Department of Medical Oncology, Mount Vernon Cancer Centre, Northwood, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Kaplan', 'Affiliation': 'Medical Research Council Clinical Trials Unit, Institute of Clinical Trials and Methodology, University College London, London, UK.'}, {'ForeName': 'Jonathan A', 'Initials': 'JA', 'LastName': 'Ledermann', 'Affiliation': 'UCL Cancer Centre Institute, University College London, London, UK; University College Hospital, London, UK.'}, {'ForeName': 'Andrew R', 'Initials': 'AR', 'LastName': 'Clamp', 'Affiliation': 'Department of Medical Oncology, The Christie NHS Foundation Trust, Manchester, UK; University of Manchester, Manchester, UK.'}]",The Lancet. Oncology,['10.1016/S1470-2045(20)30218-7'] 2843,32615145,Does connectedness to nature improve the eating behaviours of pre-schoolers? Emerging evidence from the Play&Grow randomised controlled trial in Hong Kong.,"BACKGROUND Nature-based interventions, which focus on outdoor play, mental health, and self-directed autonomous play, are becoming popular in promoting well-being. The objective of this study was to test whether connecting to nature would contribute to better feeding and eating habits in families with pre-schoolers. METHODS 241 families with children aged two to five were randomly assigned to the Intervention (IG) and Control Groups (CG). IG received 10 sessions of a family-based programme, which included a novel Connectedness to Nature (CN) element. CG received only the government's health recommendations. The effectiveness of the intervention's primary outcomes (CN, eating/feeding behaviours) was analysed by a repeated measures structural equation model with intervention status as a causal predictor. RESULTS 204 families (IG n = 120, CG n = 84) completed the measurements before and after the trial. The intervention had a medium effect on caregivers' CN (f 2  = 0.16, (95%CI = 0.06, 0.30)) and a large effect on children's CN (f 2  = 0.58, (95%CI = 0.36, 0.89)). In the IG, children's CN strongly predicted caregivers' feeding style (β = 0.48 (p < .01, 95%CI = 0.14, 0.83)) and moderately, children's eating behaviours (β = 0.21 (p = .16, 95%CI = -0.09, 0.52)). This produced a positive trend for greater vegetable consumption in the IG relative to the CG (β = 0.20 (95%CI = 0.01, 0.39) vs. β = -0.05, (95%CI = -0.18, 0.08)). Interestingly, the path values in the CG significantly reflected the traditional pattern, (e.g., parental feeding style strongly influenced children's eating behaviour (β = 0.33, p = .001, 95%CI = 0.13, 0.54). CONCLUSIONS The Play&Grow intervention positively increased caregivers' and children's CN. It also improved eating behaviors in children independent of their caregivers' feeding style. This may indicate a higher degree of autonomy in children's eating behaviour if they are exposed to nature. Further research should test the CN component in promotion of healthy eating in pre-schoolers.",2020,"The intervention had a medium effect on caregivers' CN (f 2  = 0.16, (95%CI = 0.06, 0.30)) and a large effect on children's CN (f 2  = 0.58, (95%CI = 0.36, 0.89)).","['241 families with children aged two to five', '204 families (IG n\u202f=\u202f120, CG n\u202f=\u202f84']","['Intervention (IG) and Control Groups (CG', 'Play&Grow intervention']","[""children's eating behaviours"", 'vegetable consumption', 'feeding and eating habits', ""caregivers' feeding style"", ""caregivers' and children's CN"", ""children's eating behaviour"", 'eating behaviors']","[{'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0015745', 'cui_str': 'Eating Behavior'}, {'cui': 'C0042440', 'cui_str': 'Vegetable'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0204695', 'cui_str': 'Feeding patient'}, {'cui': 'C0018464', 'cui_str': 'Habits'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0349590', 'cui_str': 'Nature'}]",241.0,0.128134,"The intervention had a medium effect on caregivers' CN (f 2  = 0.16, (95%CI = 0.06, 0.30)) and a large effect on children's CN (f 2  = 0.58, (95%CI = 0.36, 0.89)).","[{'ForeName': 'Tanja', 'Initials': 'T', 'LastName': 'Sobko', 'Affiliation': 'School of Biological Sciences, Faculty of Science, The University of Hong Kong, Hong Kong. Electronic address: tsobko@hku.hk.'}, {'ForeName': 'Gavin T L', 'Initials': 'GTL', 'LastName': 'Brown', 'Affiliation': 'Quantitative Data Analysis and Research Unit, Faculty of Education & Social Work, The University of Auckland, New Zealand.'}, {'ForeName': 'Will H G', 'Initials': 'WHG', 'LastName': 'Cheng', 'Affiliation': 'School of Biological Sciences, Faculty of Science, The University of Hong Kong, Hong Kong.'}]",Appetite,['10.1016/j.appet.2020.104781'] 2844,32615179,Early precut versus primary precut sphincterotomy to reduce post-ERCP pancreatitis: randomized controlled trial (with videos) Concise and informative title- Primary precut to prevent post ERCP pancreatitis.,"BACKGROUND AND AIMS Precut sphincterotomy, usually performed after prolonged and failed cannulation, is considered as one of the risk factors for post-ERCP pancreatitis (PEP). There are limited studies on primary needle-knife precut for the prevention of PEP. The aim of the study was to assess the safety and efficacy of primary precut. METHODS A randomized controlled trial was conducted in a tertiary care setting on patients who underwent ERCP. Patients were randomized to very early precut (group A: precut after 2 failed attempts of wire guided sphincterotome cannulation) and primary precut (group B: direct needle-knife precut). All the procedures were done by an experienced endoscopist. The primary outcome of the study was to compare the incidence of PEP between the 2 groups. RESULTS Three hundred three patients were randomized to group A (n= 152, age 48.2±15.4 years, 61 men) and group B (n= 151, age 46.7±13.8 years, 65 men). There was no significant difference in baseline characteristics and indications for ERCP between the 2 groups. Development of PEP (5.2% vs 0.67%; p = 0.04) and asymptomatic hyperamylasemia (12.5% vs 2.6%; p = 0.01) were lower in group B compared with group A. The bile duct cannulation time (13.8±2.2 vs 7.2±1.7 minutes; p=0.001) was lower in group B whereas the overall cannulation success rate (98% vs 98.6%; p =1.0) was similar in both the groups. CONCLUSIONS Primary precut by an experienced endoscopist results in low risk of PEP.",2020,Development of PEP (5.2% vs 0.67%; p = 0.04) and asymptomatic hyperamylasemia (12.5% vs 2.6%; p = 0.01) were lower in group B compared with group A.,"['patients who underwent ERCP', 'Three hundred three patients were randomized to group A (n= 152, age 48.2±15.4 years, 61 men) and group B (n= 151, age 46.7±13.8 years, 65 men']","['wire guided sphincterotome cannulation) and primary precut (group B: direct needle-knife precut', 'Early precut versus primary precut sphincterotomy']","['asymptomatic hyperamylasemia', 'safety and efficacy', 'bile duct cannulation time', 'incidence of PEP', 'low risk of PEP', 'overall cannulation success rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008310', 'cui_str': 'Endoscopic retrograde cholangiopancreatography'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0441835', 'cui_str': 'Group A'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}]","[{'cui': 'C0181089', 'cui_str': 'Guide wire'}, {'cui': 'C0183424', 'cui_str': 'Sphincterotome'}, {'cui': 'C0917707', 'cui_str': 'Cannulation'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0441189', 'cui_str': 'Direct needle'}, {'cui': 'C0181467', 'cui_str': 'Knife'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0177047', 'cui_str': 'Sphincterotomy (bladder)'}]","[{'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0221773', 'cui_str': 'Hyperamylasaemia'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0005400', 'cui_str': 'Bile duct structure'}, {'cui': 'C0917707', 'cui_str': 'Cannulation'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0008310', 'cui_str': 'Endoscopic retrograde cholangiopancreatography'}, {'cui': 'C0030305', 'cui_str': 'Pancreatitis'}, {'cui': 'C3538919', 'cui_str': 'Low risk'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",303.0,0.106841,Development of PEP (5.2% vs 0.67%; p = 0.04) and asymptomatic hyperamylasemia (12.5% vs 2.6%; p = 0.01) were lower in group B compared with group A.,"[{'ForeName': 'Sudhir', 'Initials': 'S', 'LastName': 'Maharshi', 'Affiliation': 'Assistant Professor, Department of Gastroenterology, SMS Medical College and Hospitals, Jaipur, India.'}, {'ForeName': 'Shyam Sunder', 'Initials': 'SS', 'LastName': 'Sharma', 'Affiliation': 'Senior Professor, Department of Gastroenterology, SMS Medical College and Hospitals, Jaipur, India. Electronic address: shyamsharma4@rediffmail.com.'}]",Gastrointestinal endoscopy,['10.1016/j.gie.2020.06.064'] 2845,32615237,Influence of different clinical criteria on the decision to replace restorations in primary teeth.,"OBJECTIVES This cross-sectional study nested in a randomized clinical trial was designed to evaluate the influence of using two different clinical criteria, and some other variables for the assessment of caries lesion around restorations on decision-making of restorations' replacement in primary posterior teeth. METHODS One trained and calibrated examiner assessed 550 restorations of 160 children (3-10 years old). Children were randomized to have their restorations evaluated and subsequently treated according to World Dental Federation (FDI) or Caries Associated with Restorations and Sealants (CARS) criteria. After reaching the treatment decision, the same examiner performed another evaluation using the other criteria. Spearman's correlation coefficients and 95% confidence intervals (95%CI) between the scores obtained with both criteria and respective treatment decisions were calculated. Poisson multilevel regression analysis were performed between the exploratory variables related to children, restored tooth and restoration assessment; the outcome variables were decisions related to restoration replacement, any operative intervention and presence of secondary caries. RESULTS The strongest correlation observed between the methods was for recurrence of caries. A total of 94 restorations (17.1%) were indicated for replacement with FDI criteria and 30 (5.5%) were indicated for replacement with CARS. Besides the diagnostic method used, number of decayed teeth and restorations with two and three restored surfaces were associated with the decision of replacement and presence of recurrent caries lesions. CONCLUSIONS The decision to replace posterior restorations in primary teeth is influenced by criteria used for the assessment of the restorations, as well as for children's caries experience and multisurface restorations. CLINICAL SIGNIFICANCE The decision to replace posterior restoration in primary teeth is strongly related to the evaluation method and not only by patients' risk factors.",2020,"Besides the diagnostic method used, number of decayed teeth and restorations with two and three restored surfaces were associated with the decision of replacement and presence of recurrent caries lesions. ","['One trained and calibrated examiner assessed 550 restorations of 160 children (3-10 years old', 'Children were randomized to have their restorations evaluated and subsequently treated according to World Dental Federation (FDI) or Caries Associated with Restorations and Sealants (CARS) criteria', 'primary posterior teeth', 'primary teeth']",[],"['operative intervention and presence of secondary caries', 'recurrence of caries']","[{'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C3844103', 'cui_str': '550'}, {'cui': 'C0449982', 'cui_str': 'Type of restoration'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0011365', 'cui_str': 'Health Services, Dental'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C3266841', 'cui_str': 'All deciduous teeth'}]",[],"[{'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C1882989', 'cui_str': 'Secondary caries'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0011334', 'cui_str': 'Dental caries'}]",160.0,0.0402393,"Besides the diagnostic method used, number of decayed teeth and restorations with two and three restored surfaces were associated with the decision of replacement and presence of recurrent caries lesions. ","[{'ForeName': 'Bruna Lorena Pereira', 'Initials': 'BLP', 'LastName': 'Moro', 'Affiliation': 'Department of Pediatric Dentistry, School of Dentistry, University of São Paulo, São Paulo, Brazil. Electronic address: bruna.moro@usp.br.'}, {'ForeName': 'Raiza Dias', 'Initials': 'RD', 'LastName': 'Freitas', 'Affiliation': 'Department of Pediatric Dentistry, School of Dentistry, University of São Paulo, São Paulo, Brazil. Electronic address: raizafreitas@usp.br.'}, {'ForeName': 'Laura Regina Antunes', 'Initials': 'LRA', 'LastName': 'Pontes', 'Affiliation': 'Department of Pediatric Dentistry, School of Dentistry, University of São Paulo, São Paulo, Brazil. Electronic address: laura.pontes@usp.br.'}, {'ForeName': 'Ana Laura', 'Initials': 'AL', 'LastName': 'Pássaro', 'Affiliation': 'Department of Pediatric Dentistry, School of Dentistry, University of São Paulo, São Paulo, Brazil. Electronic address: ana.passaro@usp.br.'}, {'ForeName': 'Tathiane Larissa', 'Initials': 'TL', 'LastName': 'Lenzi', 'Affiliation': 'School of Dentistry, Federal University of Rio Grande do Sul, Porto Alegre, Brazil. Electronic address: tathilenzi@hotmail.com.'}, {'ForeName': 'Tamara Kerber', 'Initials': 'TK', 'LastName': 'Tedesco', 'Affiliation': 'Graduation Program in Dentistry, Ibirapuera University, São Paulo, Brazil. Electronic address: tamarakt@usp.br.'}, {'ForeName': 'Kim Rud', 'Initials': 'KR', 'LastName': 'Ekstrand', 'Affiliation': 'Section of Cariology and Endodontics, University of Copenhagen, Copenhagen, Denmark. Electronic address: kek@sund.ku.dk.'}, {'ForeName': 'Mariana Minatel', 'Initials': 'MM', 'LastName': 'Braga', 'Affiliation': 'Department of Pediatric Dentistry, School of Dentistry, University of São Paulo, São Paulo, Brazil. Electronic address: mmbraga@usp.br.'}, {'ForeName': 'Daniela Prócida', 'Initials': 'DP', 'LastName': 'Raggio', 'Affiliation': 'Department of Pediatric Dentistry, School of Dentistry, University of São Paulo, São Paulo, Brazil. Electronic address: danielar@usp.br.'}, {'ForeName': 'Maximiliano Sérgio', 'Initials': 'MS', 'LastName': 'Cenci', 'Affiliation': 'Federal University of Pelotas, Graduate Program in Dentistry, Pelotas, Rio Grande do Sul, Brazil. Electronic address: cencims@gmail.com.'}, {'ForeName': 'Fausto Medeiros', 'Initials': 'FM', 'LastName': 'Mendes', 'Affiliation': 'Department of Pediatric Dentistry, School of Dentistry, University of São Paulo, São Paulo, Brazil. Electronic address: fmmendes@usp.br.'}]",Journal of dentistry,['10.1016/j.jdent.2020.103421'] 2846,30866056,Role of obinutuzumab exposure on clinical outcome of follicular lymphoma treated with first-line immunochemotherapy.,"AIMS Obinutuzumab (G) is a humanized type II, Fc-glycoengineered anti-CD20 monoclonal antibody used in various indications, including patients with previously untreated front-line follicular lymphoma. We investigated sources of variability in G exposure and association of progression-free survival (PFS) with average concentration over induction (C meanIND ) in front-line follicular lymphoma patients treated with G plus chemotherapy (bendamustine, CHOP, or CVP) in the GALLIUM trial. METHODS Individual exposures (C meanIND ) were obtained from a previously established population pharmacokinetic model updated with GALLIUM data. Multivariate Cox proportional hazard models and univariate Kaplan-Meier plots investigated relationships of PFS with exposure and other potential prognostic factors. RESULTS Overall, G exposure was lower in high body-weight patients and in males, and slightly lower in patients with high baseline tumour burden. Analysis of clinical outcomes showed that variability in G exposure did not impact PFS in G-bendamustine-treated patients; PFS was inferior in males and patients with FCGR2a/2b T232 T low-affinity receptor variant, and superior in patients with FCGR2a/2b I232T variant. In G-CHOP/CVP arms, PFS improved with increasing C meanIND (hazard ratio = 1.74 and 0.394 at 5 th and 95 th percentile compared to median C meanIND ) and was inferior in patients with high baseline tumour size and B symptoms. CONCLUSIONS It remains unclear whether for G-CHOP/CVP patients lower G exposure is a consequence of adverse disease biology and/or resistance to chemotherapy backbone (higher clearance in nonresponder patients, as demonstrated for rituximab) rather than being the cause of poorer clinical outcome. A study with >1 dose level of G could help resolve this uncertainty.",2019,"In G-CHOP/CVP arms, PFS improved with increasing C meanIND (hazard ratio = 1.74 and 0.394 at 5 th and 95 th percentile compared to median C meanIND ) and was inferior in patients with high baseline tumour size and B symptoms. ","['front-line follicular lymphoma patients treated with', 'patients with previously untreated front-line follicular lymphoma']","['first-line immunochemotherapy', 'average concentration over induction (C meanIND ', 'G plus chemotherapy (bendamustine, CHOP, or CVP', 'obinutuzumab exposure', 'Obinutuzumab (G']","['Overall, G exposure']","[{'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0024301', 'cui_str': 'Follicular lymphoma'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}]","[{'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C4087148', 'cui_str': 'Immunochemotherapy'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0525079', 'cui_str': 'bendamustine'}, {'cui': 'C0055598', 'cui_str': 'CHOP protocol'}, {'cui': 'C0056633', 'cui_str': 'COP protocol 2'}, {'cui': 'C2742503', 'cui_str': 'obinutuzumab'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}]",,0.0747965,"In G-CHOP/CVP arms, PFS improved with increasing C meanIND (hazard ratio = 1.74 and 0.394 at 5 th and 95 th percentile compared to median C meanIND ) and was inferior in patients with high baseline tumour size and B symptoms. ","[{'ForeName': 'Candice', 'Initials': 'C', 'LastName': 'Jamois', 'Affiliation': 'Department of Clinical Pharmacology, F. Hoffmann-La Roche, Roche Innovation Center Basel, Switzerland.'}, {'ForeName': 'Ekaterina', 'Initials': 'E', 'LastName': 'Gibiansky', 'Affiliation': 'QuantPharm LLC, North Potomac, MD, USA.'}, {'ForeName': 'Leonid', 'Initials': 'L', 'LastName': 'Gibiansky', 'Affiliation': 'QuantPharm LLC, North Potomac, MD, USA.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Buchheit', 'Affiliation': 'Department of Clinical Pharmacology, F. Hoffmann-La Roche, Roche Innovation Center Basel, Switzerland.'}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Sahin', 'Affiliation': 'Roche Innovation Center, Welwyn, UK.'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Cartron', 'Affiliation': 'Department of Hematology, CHU Montpellier, Montpellier, France.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Marcus', 'Affiliation': 'Kings College Hospital, London, UK.'}, {'ForeName': 'Wolfgang', 'Initials': 'W', 'LastName': 'Hiddemann', 'Affiliation': 'Department of Medicine III, University Hospital, LMU Munich, Germany.'}, {'ForeName': 'John F', 'Initials': 'JF', 'LastName': 'Seymour', 'Affiliation': 'Peter MacCallum Cancer Centre, Royal Melbourne Hospital and University of Melbourne, Melbourne, Australia.'}, {'ForeName': 'Jonathan C', 'Initials': 'JC', 'LastName': 'Strefford', 'Affiliation': 'Cancer Genomics, Cancer Sciences, Faculty of Medicine, Group University of Southampton, Southampton, UK.'}, {'ForeName': 'Chantal E', 'Initials': 'CE', 'LastName': 'Hargreaves', 'Affiliation': 'Cancer Genomics, Cancer Sciences, Faculty of Medicine, Group University of Southampton, Southampton, UK.'}, {'ForeName': 'Georgina', 'Initials': 'G', 'LastName': 'Meneses-Lorente', 'Affiliation': 'Roche Innovation Center, Welwyn, UK.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Frey', 'Affiliation': 'Department of Clinical Pharmacology, F. Hoffmann-La Roche, Roche Innovation Center Basel, Switzerland.'}, {'ForeName': 'Günter', 'Initials': 'G', 'LastName': 'Fingerle-Rowson', 'Affiliation': 'Pharma Development Oncology, F. Hoffmann-La Roche, Basel, Switzerland.'}]",British journal of clinical pharmacology,['10.1111/bcp.13920'] 2847,30940400,Relationships between smartphone social behavior and relapse in schizophrenia: A preliminary report.,"Social dysfunction is a hallmark of schizophrenia. Social isolation may increase individuals' risk for psychotic symptom exacerbation and relapse. Monitoring and timely detection of shifts in social functioning are hampered by the limitations of traditional clinic-based assessment strategies. Ubiquitous mobile technologies such as smartphones introduce new opportunities to capture objective digital indicators of social behavior. The goal of this study was to evaluate whether smartphone-collected digital measures of social behavior can provide early indication of relapse events among individuals with schizophrenia. Sixty-one individuals with schizophrenia with elevated risk for relapse were given smartphones with the CrossCheck behavioral sensing system for a year of remote monitoring. CrossCheck leveraged the device's microphone, call record, and text messaging log to capture digital socialization data. Relapse events including psychiatric hospitalizations, suicidal ideation, and significant psychiatric symptom exacerbations were recorded by trained assessors. Exploratory mixed effects models examined relationships of social behavior to relapse, finding that reductions in number and duration of outgoing calls, as well as number of text messages were associated with relapses. Number and duration of incoming phone calls and in-person conversations were not. Smartphone enabled social activity may provide an important metric in determining relapse risk in schizophrenia and provide access to sensitive, meaningful and ecologically valid data streams never before available in routine care.",2019,Number and duration of incoming phone calls and in-person conversations were not.,"['Sixty-one individuals with schizophrenia with elevated risk for relapse were given smartphones with the CrossCheck behavioral sensing system for a year of remote monitoring', 'schizophrenia', 'individuals with schizophrenia']",['smartphone-collected digital measures of social behavior'],"['psychiatric hospitalizations, suicidal ideation, and significant psychiatric symptom exacerbations', 'Number and duration of incoming phone calls and in-person conversations', 'number and duration of outgoing calls']","[{'cui': 'C4517832', 'cui_str': '61'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}]","[{'cui': 'C3204335', 'cui_str': 'Smart Phones'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0037397', 'cui_str': 'Social behavior'}]","[{'cui': 'C0033873', 'cui_str': 'Psychiatry'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0424000', 'cui_str': 'Suicidal thoughts'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0233401', 'cui_str': 'Psychiatric symptom'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0027361', 'cui_str': 'Person'}]",61.0,0.0385295,Number and duration of incoming phone calls and in-person conversations were not.,"[{'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Buck', 'Affiliation': 'Health Services Research & Development, Puget Sound VA Healthcare System, Seattle, WA, United States of America; Department of Health Services, School of Public Health, Univ. of Washington, Seattle, WA, United States of America; Behavioral Research in Technology and Engineering (BRiTE) Center, Department of Psychiatry and Behavioral Sciences, University of Washington, Seattle, WA, United States of America. Electronic address: buckbe@uw.edu.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Scherer', 'Affiliation': 'Geisel School of Medicine, Dartmouth College, Hanover, NH, United States of America.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Brian', 'Affiliation': 'Behavioral Research in Technology and Engineering (BRiTE) Center, Department of Psychiatry and Behavioral Sciences, University of Washington, Seattle, WA, United States of America.'}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Wang', 'Affiliation': 'Department of Computer Science, Dartmouth College, Hanover, NH, United States of America.'}, {'ForeName': 'Weichen', 'Initials': 'W', 'LastName': 'Wang', 'Affiliation': 'Department of Computer Science, Dartmouth College, Hanover, NH, United States of America.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Campbell', 'Affiliation': 'Department of Computer Science, Dartmouth College, Hanover, NH, United States of America.'}, {'ForeName': 'Tanzeem', 'Initials': 'T', 'LastName': 'Choudhury', 'Affiliation': 'Department of Information Science, Cornell University, Ithaca, NY, United States of America.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Hauser', 'Affiliation': 'The Zucker Hillside Hospital, Northwell Health, Glen Oaks, NY, United States of America; Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Hempstead, NY, United States of America.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Kane', 'Affiliation': 'The Zucker Hillside Hospital, Northwell Health, Glen Oaks, NY, United States of America; Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Hempstead, NY, United States of America.'}, {'ForeName': 'Dror', 'Initials': 'D', 'LastName': 'Ben-Zeev', 'Affiliation': 'Behavioral Research in Technology and Engineering (BRiTE) Center, Department of Psychiatry and Behavioral Sciences, University of Washington, Seattle, WA, United States of America.'}]",Schizophrenia research,['10.1016/j.schres.2019.03.014'] 2848,32619212,"Contrasting effects of viscous and particulate fibers on colonic fermentation in vitro and in vivo, and their impact on intestinal water studied by MRI in a randomized trial.","BACKGROUND Wheat bran, nopal, and psyllium are examples of particulate, viscous and particulate, and viscous fibers, respectively, with laxative properties yet contrasting fermentability. OBJECTIVES We assessed the fermentability of these fibers in vitro and their effects on intestinal function relevant to laxation in vivo using MRI. METHODS Each fiber was predigested prior to measuring gas production in vitro during 48-h anaerobic incubation with healthy fecal samples. We performed a randomized, 3-way crossover trial in 14 healthy volunteers who ingested 7.5 g fiber twice on the day prior to study initiation and once with the study test meal. Serial MRI scans obtained after fasting and hourly for 4 h following meal ingestion were used to assess small bowel water content (SBWC), colonic volumes, and T1 of the ascending colon (T1AC) as measures of colonic water. Breath samples for hydrogen analysis were obtained while patients were in the fasted state and every 30 min for 4 h following meal ingestion. RESULTS In vitro, the onset of gas production was significantly delayed with psyllium (mean ± SD: 14 ± 5 h) compared with wheat bran (6 ± 2 h, P = 0.003) and was associated with a smaller total gas volume (P = 0.01). Prefeeding all 3 fibers for 24 h was associated with an increased fasting T1AC (>75% of values >90th centile of the normal range). There was a further rise during the 4 h after psyllium (0.3 ± 0.3 s P = 0.009), a fall with wheat bran (-0.2 ± 0.2 s; P = 0.02), but no change with nopal (0.0 ± 0.1 s, P = 0.2). SBWC increased for all fibers; nopal stimulated more water than wheat bran [AUC mean (95% CI) difference: 7.1 (0.6, 13.8) L/min, P = 0.03].Breath hydrogen rose significantly after wheat bran and nopal but not after psyllium (P < 0.0001). CONCLUSION Both viscous and particulate fibers are equally effective at increasing colonic T1 over a period of 24 h. Mechanisms include water trapping in the small bowel by viscous fibers and delivery of substrates to the colonic microbiota by more fermentable particulate fiber. This trial was registered at clinicaltrials.gov as NCT03263065.",2020,Both viscous and particulate fibers are equally effective at increasing colonic T1 over a period of 24 h. Mechanisms include water trapping in the small bowel by viscous fibers and delivery of substrates to the colonic microbiota by more fermentable particulate fiber.,['14 healthy volunteers who ingested 7.5 g fiber twice on the day prior to study initiation and once with the study test meal'],['viscous and particulate fibers'],"['increased fasting T1AC', 'onset of gas production', 'SBWC', 'smaller total gas volume', 'small bowel water content (SBWC), colonic volumes, and T1 of the ascending colon (T1AC']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0232478', 'cui_str': 'Ingestion'}, {'cui': 'C4517859', 'cui_str': '7.5'}, {'cui': 'C0012173', 'cui_str': 'Dietary fiber'}, {'cui': 'C1720725', 'cui_str': 'Twice'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1998602', 'cui_str': 'Meals'}]","[{'cui': 'C0457784', 'cui_str': 'Particulate'}, {'cui': 'C0012173', 'cui_str': 'Dietary fiber'}]","[{'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0332162', 'cui_str': 'Onset of'}, {'cui': 'C0017110', 'cui_str': 'Gas'}, {'cui': 'C0021852', 'cui_str': 'Small intestinal'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C0423896', 'cui_str': 'Feeling content'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449468', 'cui_str': 'Volume'}, {'cui': 'C0009368', 'cui_str': 'Colonic'}, {'cui': 'C0227375', 'cui_str': 'Ascending colon structure'}]",14.0,0.0430021,Both viscous and particulate fibers are equally effective at increasing colonic T1 over a period of 24 h. Mechanisms include water trapping in the small bowel by viscous fibers and delivery of substrates to the colonic microbiota by more fermentable particulate fiber.,"[{'ForeName': 'David', 'Initials': 'D', 'LastName': 'Gunn', 'Affiliation': 'NIHR Nottingham Biomedical Research Centre, Nottingham University Hospitals NHS Trust and the University of Nottingham, Nottingham, United Kingdom.'}, {'ForeName': 'Rajani', 'Initials': 'R', 'LastName': 'Murthy', 'Affiliation': 'Nottingham Digestive Diseases Centre, School of Medicine, University of Nottingham, Nottingham, United Kingdom.'}, {'ForeName': 'Giles', 'Initials': 'G', 'LastName': 'Major', 'Affiliation': 'NIHR Nottingham Biomedical Research Centre, Nottingham University Hospitals NHS Trust and the University of Nottingham, Nottingham, United Kingdom.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Wilkinson-Smith', 'Affiliation': 'NIHR Nottingham Biomedical Research Centre, Nottingham University Hospitals NHS Trust and the University of Nottingham, Nottingham, United Kingdom.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Hoad', 'Affiliation': 'NIHR Nottingham Biomedical Research Centre, Nottingham University Hospitals NHS Trust and the University of Nottingham, Nottingham, United Kingdom.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Marciani', 'Affiliation': 'NIHR Nottingham Biomedical Research Centre, Nottingham University Hospitals NHS Trust and the University of Nottingham, Nottingham, United Kingdom.'}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Remes-Troche', 'Affiliation': 'Digestive Physiology and Motility Lab, Medical Biological Research Institute, University of Veracruz, Veracruz, Mexico.'}, {'ForeName': 'Samantha', 'Initials': 'S', 'LastName': 'Gill', 'Affiliation': ""King's College London, Department of Nutritional Sciences, London, United Kingdom.""}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Rossi', 'Affiliation': ""King's College London, Department of Nutritional Sciences, London, United Kingdom.""}, {'ForeName': 'Hannah', 'Initials': 'H', 'LastName': 'Harris', 'Affiliation': 'Quadram Institute of Biosciences, Food, Innovation and Health, Norwich Research Park, Norwich, United Kingdom.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Ahn-Jarvis', 'Affiliation': 'Quadram Institute of Biosciences, Food, Innovation and Health, Norwich Research Park, Norwich, United Kingdom.'}, {'ForeName': 'Fred', 'Initials': 'F', 'LastName': 'Warren', 'Affiliation': 'Quadram Institute of Biosciences, Food, Innovation and Health, Norwich Research Park, Norwich, United Kingdom.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Whelan', 'Affiliation': ""King's College London, Department of Nutritional Sciences, London, United Kingdom.""}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Spiller', 'Affiliation': 'NIHR Nottingham Biomedical Research Centre, Nottingham University Hospitals NHS Trust and the University of Nottingham, Nottingham, United Kingdom.'}]",The American journal of clinical nutrition,['10.1093/ajcn/nqaa173'] 2849,32619240,Cognitive Effects of Split and Continuous Sleep Schedules in Adolescents Differ According to Total Sleep Opportunity.,"STUDY OBJECTIVES We compared the basic cognitive functions of adolescents undergoing split (nocturnal sleep + daytime nap) and continuous nocturnal sleep schedules when total sleep opportunity was either below or within the recommended range (i.e. 6.5 or 8 h). METHODS Adolescent participants (age: 15-19 y) in the 8-h split (n = 24) and continuous (n = 29) sleep groups were compared with 6.5-h split and continuous sleep groups from a previous study (n = 58; Lo et al., 2019). These protocols involved 2 baseline nights (9-h time-in-bed [TIB]), 5 nights of sleep manipulation, 2 recovery nights (9-h TIB), followed by a second cycle of sleep manipulation (3 nights) and recovery (2 nights). Cognitive performance, subjective sleepiness, and mood were evaluated daily; sleep was assessed using polysomnography. RESULTS Splitting 6.5 h of sleep with a mid-afternoon nap offered a boost to cognitive function compared to continuous nocturnal sleep. However, when total TIB across 24 h increased to 8 h, the split and continuous sleep groups performed comparably in tests evaluating vigilance, working memory, executive function, processing speed, subjective sleepiness and mood. CONCLUSIONS In adolescents, the effects of split sleep on basic cognitive functions vary by the amount of total sleep obtained. As long as the total sleep opportunity across 24 h is within the recommended range, students may fulfil sleep requirements by adopting a split sleep schedule consisting of a shorter period of nocturnal sleep combined with a mid-afternoon nap, without significant impact on basic cognitive functions. CLINICAL TRIAL ID NCT04044885.",2020,"However, when total TIB across 24 h increased to 8 h, the split and continuous sleep groups performed comparably in tests evaluating vigilance, working memory, executive function, processing speed, subjective sleepiness and mood. ","['Adolescents Differ', 'adolescents undergoing', 'Adolescent participants (age: 15-19 y) in the 8-h split (n = 24) and continuous (n = 29) sleep groups']","['Split and Continuous Sleep Schedules', 'split (nocturnal sleep + daytime nap) and continuous nocturnal sleep schedules', 'split sleep']","['tests evaluating vigilance, working memory, executive function, processing speed, subjective sleepiness and mood', 'Cognitive performance, subjective sleepiness, and mood were evaluated daily; sleep', 'total TIB']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0332169', 'cui_str': 'Daytime'}, {'cui': 'C0067518', 'cui_str': 'N-(4-aminophenethyl)spiroperidol'}]","[{'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0043012', 'cui_str': 'Wakefulness'}, {'cui': 'C0025265', 'cui_str': 'Immediate memory'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0013144', 'cui_str': 'Drowsiness'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",,0.0146999,"However, when total TIB across 24 h increased to 8 h, the split and continuous sleep groups performed comparably in tests evaluating vigilance, working memory, executive function, processing speed, subjective sleepiness and mood. ","[{'ForeName': 'June C', 'Initials': 'JC', 'LastName': 'Lo', 'Affiliation': 'Centre for Sleep and Cognition, Yong Loo Lin School of Medicine, National University of Singapore, Singapore.'}, {'ForeName': 'Ruth L F', 'Initials': 'RLF', 'LastName': 'Leong', 'Affiliation': 'Centre for Sleep and Cognition, Yong Loo Lin School of Medicine, National University of Singapore, Singapore.'}, {'ForeName': 'Alyssa S C', 'Initials': 'ASC', 'LastName': 'Ng', 'Affiliation': 'Centre for Sleep and Cognition, Yong Loo Lin School of Medicine, National University of Singapore, Singapore.'}, {'ForeName': 'S Azrin', 'Initials': 'SA', 'LastName': 'Jamaluddin', 'Affiliation': 'Centre for Sleep and Cognition, Yong Loo Lin School of Medicine, National University of Singapore, Singapore.'}, {'ForeName': 'Ju Lynn', 'Initials': 'JL', 'LastName': 'Ong', 'Affiliation': 'Centre for Sleep and Cognition, Yong Loo Lin School of Medicine, National University of Singapore, Singapore.'}, {'ForeName': 'Shohreh', 'Initials': 'S', 'LastName': 'Ghorbani', 'Affiliation': 'Centre for Sleep and Cognition, Yong Loo Lin School of Medicine, National University of Singapore, Singapore.'}, {'ForeName': 'TeYang', 'Initials': 'T', 'LastName': 'Lau', 'Affiliation': 'Centre for Sleep and Cognition, Yong Loo Lin School of Medicine, National University of Singapore, Singapore.'}, {'ForeName': 'Nicholas I Y N', 'Initials': 'NIYN', 'LastName': 'Chee', 'Affiliation': 'Centre for Sleep and Cognition, Yong Loo Lin School of Medicine, National University of Singapore, Singapore.'}, {'ForeName': 'Joshua J', 'Initials': 'JJ', 'LastName': 'Gooley', 'Affiliation': 'Neuroscience and Behavioral Disorders Program, Duke-NUS Medical School, Singapore.'}, {'ForeName': 'Michael W L', 'Initials': 'MWL', 'LastName': 'Chee', 'Affiliation': 'Centre for Sleep and Cognition, Yong Loo Lin School of Medicine, National University of Singapore, Singapore.'}]",Sleep,['10.1093/sleep/zsaa129'] 2850,32619274,The impact of two root canal treatment protocols on the oral health-related quality of life: A randomised controlled pragmatic clinical trial.,"AIM To assess the impact of two canal treatment protocols on the oral health-related quality of life (OHRQoL) of patients in need of root canal treatment on their anterior teeth. METHODOLOGY The sample consisted of 120 participants (mean age: 34 years old) enrolled in a pragmatic randomised clinical trial evaluating two root canal treatment protocols. Anterior teeth with nonvital pulps were allocated for root canal preparation with either hand files and filled with lateral compaction of gutta-percha (manual protocol) or canal preparation with a single file in a reciprocating movement and filled with a single cone technique (Reciproc protocol). OHRQoL data were assessed using the Oral Health Impact Profile instrument (OHIP-14), which was administered before the root canal intervention (baseline), and 6 and 12 months after treatment. Demographic and clinical characteristics of participants were collected at baseline. Data were analysed using bivariate analyses, Poisson univariate and multiple regression (α = 0.05). RESULTS The drop-out rate from baseline was 27% and 28% at 6 and 12 months after the treatment, respectively. Both root canal protocols significantly enhanced patients' OHRQoL, regardless of the follow-up time (p < 0.001). After 6 months, patients treated with the Reciproc protocol had significantly lower OHIP-14 overall scores (p = 0.030), as well as significantly lower scores for psychological discomfort (p = 0.031) and social disability (p = 0.013). After 12 months, no significant difference was observed between the two root canal protocols for OHIP-14 overall scores (p = 0.174). Either large or moderate effect sizes were observed for all domains and overall scores at both evaluation times, irrespective of the protocol. Low-income person (RR = 2. 03) and Reciproc protocol (RR = 1.52) had a higher likelihood of a positive impact on OHRQoL 12 months after root canal treatment. CONCLUSIONS The two root canal protocols improved the OHRQoL and differences in scores were observed only after 6 months with poorer OHRQoL for the manual protocol. After 12 months, patients with low-income status and treated with Reciproc reported a greater improvement in OHRQoL scores.",2020,"Either large or moderate effect sizes were observed for all domains and overall scores at both evaluation times, irrespective of the protocol.","['120 participants (mean age: 34 years old', 'patients in need of root canal treatment on their anterior teeth', 'Anterior teeth with nonvital pulps']",['root canal preparation with either hand files and filled with lateral compaction of gutta-percha (manual protocol) or canal preparation with a single file in a reciprocating movement and filled with a single cone technique (Reciproc protocol'],"['social disability', 'OHRQoL data', 'OHIP-14 overall scores', 'OHRQoL and differences in scores', 'psychological discomfort', 'oral health-related quality of life', 'oral health-related quality of life (OHRQoL', 'OHRQoL scores']","[{'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0035849', 'cui_str': 'Therapy, Root Canal'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0040426', 'cui_str': 'Tooth structure'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0011399', 'cui_str': 'Structure of pulp of tooth'}]","[{'cui': 'C0282543', 'cui_str': 'Root canal preparation'}, {'cui': 'C0018563', 'cui_str': 'Hand'}, {'cui': 'C0016094', 'cui_str': 'Filing'}, {'cui': 'C0205093', 'cui_str': 'Lateral'}, {'cui': 'C0018407', 'cui_str': 'Gutta percha'}, {'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0442711', 'cui_str': 'Protocols'}, {'cui': 'C0086881', 'cui_str': 'Pulp canal'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0206428', 'cui_str': 'Cone of retina'}, {'cui': 'C0025664', 'cui_str': 'methods'}]","[{'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}]",120.0,0.0932869,"Either large or moderate effect sizes were observed for all domains and overall scores at both evaluation times, irrespective of the protocol.","[{'ForeName': 'F E', 'Initials': 'FE', 'LastName': 'Figueiredo', 'Affiliation': 'Graduate Program in Health Sciences, Federal University of Sergipe, Aracaju, SE, Brazil.'}, {'ForeName': 'L F', 'Initials': 'LF', 'LastName': 'Lima', 'Affiliation': 'Private clinic, Aracaju, SE, Brazil.'}, {'ForeName': 'L S', 'Initials': 'LS', 'LastName': 'Oliveira', 'Affiliation': 'Graduate Program in Health Sciences, Federal University of Sergipe, Aracaju, SE, Brazil.'}, {'ForeName': 'I M', 'Initials': 'IM', 'LastName': 'Bernardino', 'Affiliation': 'Department of Dentistry, State University of Paraíba, Campina Grande, PB, Brazil.'}, {'ForeName': 'S M', 'Initials': 'SM', 'LastName': 'Paiva', 'Affiliation': 'Department of Pediatric Dentistry, School of Dentistry, Federal University of Minas Gerais, MG, Brazil, Belo Horizonte.'}, {'ForeName': 'A L', 'Initials': 'AL', 'LastName': 'Faria-E-Silva', 'Affiliation': 'Department of Dentistry, Federal University of Sergipe, Aracaju, SE, Brazil.'}]",International endodontic journal,['10.1111/iej.13356'] 2851,32619561,ERGO2: A prospective randomized trial of calorie restricted ketogenic diet and fasting in addition to re-irradiation for malignant glioma.,"PURPOSE XXXX is the first randomized clinical trial of calorically restricted ketogenic diet (KD) and intermittent fasting (KD-IF) in addition to re-irradiation for recurrent malignant gliomas. METHODS 50 Patients were randomized 1:1 to re-irradiation combined with either calorically unrestricted diet (SD) or KD-IF. The KD-IF schedule included 3 days of KD (21-23 kcal/kg/d), followed by 3 days of fasting and again 3 days of KD. Primary endpoint was progression-free survival (PFS) rate at 6 months (PFS6). Secondary endpoints were PFS, local PFS, overall survival (OS), frequency of epileptic seizures, rate of ketosis and quality of life. RESULTS Four patients quit the trial before treatment and three patients stopped KD-IF prematurely. Of the 20 patients who completed KD-IF, 17 patients developed ketosis at day 6 and glucose levels declined significantly. KD-IF was well-tolerated with a modest weight loss of -2.1±1.8 kg. No severe adverse events attributable to the diet occurred. PFS6 was not significantly different between the two groups (KD-IF: 20%, SD: 16%). Similarly, no difference in PFS, local PFS6 and OS was observable. Explorative analysis revealed that patients of the KD-IF group who had a glucose of less than the median (83.5 mg/dl) on day 6 had a significantly longer PFS and OS compared to those above the median (p <0.05). CONCLUSION KD-IF is feasible and effective in inducing ketosis in heavily pretreated patients with recurrent glioma. However, the short schedule reported here failed to increase the efficacy of re-irradiation.",2020,"PFS6 was not significantly different between the two groups (KD-IF: 20%, SD: 16%).","['50 Patients', 'heavily pretreated patients with recurrent glioma', 'malignant glioma']","['calorie restricted ketogenic diet and fasting in addition to re-irradiation', 're-irradiation combined with either calorically unrestricted diet (SD) or KD-IF', 'ERGO2', 'calorically restricted ketogenic diet (KD) and intermittent fasting (KD-IF']","['ketosis at day 6 and glucose levels', 'progression-free survival (PFS) rate at 6 months (PFS6', 'severe adverse events', 'PFS, local PFS, overall survival (OS), frequency of epileptic seizures, rate of ketosis and quality of life', 'PFS6', 'PFS, local PFS6 and OS', 'PFS and OS']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1455761', 'cui_str': 'Episodic'}, {'cui': 'C0017638', 'cui_str': 'Glioma'}, {'cui': 'C0555198', 'cui_str': 'Glioma, malignant, no ICD-O subtype'}]","[{'cui': 'C0439259', 'cui_str': 'kcal'}, {'cui': 'C0443288', 'cui_str': 'Restricted'}, {'cui': 'C0259972', 'cui_str': 'Ketogenic diet'}, {'cui': 'C0015663', 'cui_str': 'Fasting'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C4042794', 'cui_str': 'Re Irradiation'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C4704881', 'cui_str': 'Intermittent Fasting'}]","[{'cui': 'C0022638', 'cui_str': 'Ketosis'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C1519275', 'cui_str': 'Common terminology criteria for adverse events grade 3'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0014544', 'cui_str': 'Epilepsy'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}]",50.0,0.0608039,"PFS6 was not significantly different between the two groups (KD-IF: 20%, SD: 16%).","[{'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Voss', 'Affiliation': 'Dr. Senckenberg Institute of Neurooncology, University Hospital Frankfurt, Goethe University, Schleusenweg 2-16, 60528 Frankfurt/Main, Germany; University Cancer Center Frankfurt (UCT), University Hospital Frankfurt, Goethe University, Theodor-Stern-Kai 7, 60590 Frankfurt/Main, Germany; German Cancer Consortium (DKTK), partner site Frankfurt/Mainz; and German Cancer Research Center (DKFZ), Stiftung des öffentlichen Rechts, Im Neuenheimer Feld 280, 69120 Heidelberg, Germany; Frankfurt Cancer Institute (FCI), Georg-Speyer-Haus, Paul-Ehrlich-Straße 42-44, 60596 Frankfurt/Main, Germany. Electronic address: martin.voss@kgu.de.'}, {'ForeName': '', 'Initials': '', 'LastName': 'Marlies Wagner', 'Affiliation': 'University Cancer Center Frankfurt (UCT), University Hospital Frankfurt, Goethe University, Theodor-Stern-Kai 7, 60590 Frankfurt/Main, Germany; German Cancer Consortium (DKTK), partner site Frankfurt/Mainz; and German Cancer Research Center (DKFZ), Stiftung des öffentlichen Rechts, Im Neuenheimer Feld 280, 69120 Heidelberg, Germany; Frankfurt Cancer Institute (FCI), Georg-Speyer-Haus, Paul-Ehrlich-Straße 42-44, 60596 Frankfurt/Main, Germany; Institute of Neuroradiology, University Hospital Frankfurt, Goethe University, Schleusenweg 2-16, 60528 Frankfurt/Main, Germany.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'von Mettenheim', 'Affiliation': 'Dr. Senckenberg Institute of Neurooncology, University Hospital Frankfurt, Goethe University, Schleusenweg 2-16, 60528 Frankfurt/Main, Germany; University Cancer Center Frankfurt (UCT), University Hospital Frankfurt, Goethe University, Theodor-Stern-Kai 7, 60590 Frankfurt/Main, Germany; German Cancer Consortium (DKTK), partner site Frankfurt/Mainz; and German Cancer Research Center (DKFZ), Stiftung des öffentlichen Rechts, Im Neuenheimer Feld 280, 69120 Heidelberg, Germany; Frankfurt Cancer Institute (FCI), Georg-Speyer-Haus, Paul-Ehrlich-Straße 42-44, 60596 Frankfurt/Main, Germany.'}, {'ForeName': 'Patrick N', 'Initials': 'PN', 'LastName': 'Harter', 'Affiliation': 'University Cancer Center Frankfurt (UCT), University Hospital Frankfurt, Goethe University, Theodor-Stern-Kai 7, 60590 Frankfurt/Main, Germany; German Cancer Consortium (DKTK), partner site Frankfurt/Mainz; and German Cancer Research Center (DKFZ), Stiftung des öffentlichen Rechts, Im Neuenheimer Feld 280, 69120 Heidelberg, Germany; Frankfurt Cancer Institute (FCI), Georg-Speyer-Haus, Paul-Ehrlich-Straße 42-44, 60596 Frankfurt/Main, Germany; Institute of Neurology (Edinger-Institute), University Hospital Frankfurt, Goethe University, Heinrich-Hoffmann Strasse 7, 60528 Frankfurt/Main, Germany.'}, {'ForeName': 'Katharina J', 'Initials': 'KJ', 'LastName': 'Wenger', 'Affiliation': 'University Cancer Center Frankfurt (UCT), University Hospital Frankfurt, Goethe University, Theodor-Stern-Kai 7, 60590 Frankfurt/Main, Germany; German Cancer Consortium (DKTK), partner site Frankfurt/Mainz; and German Cancer Research Center (DKFZ), Stiftung des öffentlichen Rechts, Im Neuenheimer Feld 280, 69120 Heidelberg, Germany; Frankfurt Cancer Institute (FCI), Georg-Speyer-Haus, Paul-Ehrlich-Straße 42-44, 60596 Frankfurt/Main, Germany; Institute of Neuroradiology, University Hospital Frankfurt, Goethe University, Schleusenweg 2-16, 60528 Frankfurt/Main, Germany.'}, {'ForeName': 'Kea', 'Initials': 'K', 'LastName': 'Franz', 'Affiliation': 'University Cancer Center Frankfurt (UCT), University Hospital Frankfurt, Goethe University, Theodor-Stern-Kai 7, 60590 Frankfurt/Main, Germany; German Cancer Consortium (DKTK), partner site Frankfurt/Mainz; and German Cancer Research Center (DKFZ), Stiftung des öffentlichen Rechts, Im Neuenheimer Feld 280, 69120 Heidelberg, Germany; Frankfurt Cancer Institute (FCI), Georg-Speyer-Haus, Paul-Ehrlich-Straße 42-44, 60596 Frankfurt/Main, Germany; Departement of Neurosurgery, University Hospital Frankfurt, Goethe University, Schleusenweg 2-16, 60528 Frankfurt/Main, Germany.'}, {'ForeName': 'Jörg', 'Initials': 'J', 'LastName': 'Bojunga', 'Affiliation': 'Department of Medicine 1, University Hospital Frankfurt, Goethe University, Theodor-Stern-Kai 7, 60590 Frankfurt/Main, Germany.'}, {'ForeName': 'Manuela', 'Initials': 'M', 'LastName': 'Vetter', 'Affiliation': 'Dr. Senckenberg Institute of Neurooncology, University Hospital Frankfurt, Goethe University, Schleusenweg 2-16, 60528 Frankfurt/Main, Germany; University Cancer Center Frankfurt (UCT), University Hospital Frankfurt, Goethe University, Theodor-Stern-Kai 7, 60590 Frankfurt/Main, Germany; German Cancer Consortium (DKTK), partner site Frankfurt/Mainz; and German Cancer Research Center (DKFZ), Stiftung des öffentlichen Rechts, Im Neuenheimer Feld 280, 69120 Heidelberg, Germany; Frankfurt Cancer Institute (FCI), Georg-Speyer-Haus, Paul-Ehrlich-Straße 42-44, 60596 Frankfurt/Main, Germany.'}, {'ForeName': 'Ruediger', 'Initials': 'R', 'LastName': 'Gerlach', 'Affiliation': 'Department of Neurosurgery, HELIOS Hospital Erfurt, Nordhäuser Straße 74, 99089 Erfurt Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Glatzel', 'Affiliation': 'Department of Radiation Oncology, HELIOS Hospital Erfurt, Nordhäuser Straße 74, 99089 Erfurt Germany.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Paulsen', 'Affiliation': 'Department of Radiation Oncology, University Hospital Tübingen, Hoppe-Seyler-Straße 3, 72076 Tübingen, Germany.'}, {'ForeName': 'Elke', 'Initials': 'E', 'LastName': 'Hattingen', 'Affiliation': 'University Cancer Center Frankfurt (UCT), University Hospital Frankfurt, Goethe University, Theodor-Stern-Kai 7, 60590 Frankfurt/Main, Germany; German Cancer Consortium (DKTK), partner site Frankfurt/Mainz; and German Cancer Research Center (DKFZ), Stiftung des öffentlichen Rechts, Im Neuenheimer Feld 280, 69120 Heidelberg, Germany; Frankfurt Cancer Institute (FCI), Georg-Speyer-Haus, Paul-Ehrlich-Straße 42-44, 60596 Frankfurt/Main, Germany; Institute of Neuroradiology, University Hospital Frankfurt, Goethe University, Schleusenweg 2-16, 60528 Frankfurt/Main, Germany.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Baehr', 'Affiliation': 'Dr. Senckenberg Institute of Neurooncology, University Hospital Frankfurt, Goethe University, Schleusenweg 2-16, 60528 Frankfurt/Main, Germany; University Cancer Center Frankfurt (UCT), University Hospital Frankfurt, Goethe University, Theodor-Stern-Kai 7, 60590 Frankfurt/Main, Germany; German Cancer Consortium (DKTK), partner site Frankfurt/Mainz; and German Cancer Research Center (DKFZ), Stiftung des öffentlichen Rechts, Im Neuenheimer Feld 280, 69120 Heidelberg, Germany; Frankfurt Cancer Institute (FCI), Georg-Speyer-Haus, Paul-Ehrlich-Straße 42-44, 60596 Frankfurt/Main, Germany.'}, {'ForeName': 'Michael W', 'Initials': 'MW', 'LastName': 'Ronellenfitsch', 'Affiliation': 'Dr. Senckenberg Institute of Neurooncology, University Hospital Frankfurt, Goethe University, Schleusenweg 2-16, 60528 Frankfurt/Main, Germany; University Cancer Center Frankfurt (UCT), University Hospital Frankfurt, Goethe University, Theodor-Stern-Kai 7, 60590 Frankfurt/Main, Germany; German Cancer Consortium (DKTK), partner site Frankfurt/Mainz; and German Cancer Research Center (DKFZ), Stiftung des öffentlichen Rechts, Im Neuenheimer Feld 280, 69120 Heidelberg, Germany; Frankfurt Cancer Institute (FCI), Georg-Speyer-Haus, Paul-Ehrlich-Straße 42-44, 60596 Frankfurt/Main, Germany.'}, {'ForeName': 'Emmanouil', 'Initials': 'E', 'LastName': 'Fokas', 'Affiliation': 'University Cancer Center Frankfurt (UCT), University Hospital Frankfurt, Goethe University, Theodor-Stern-Kai 7, 60590 Frankfurt/Main, Germany; German Cancer Consortium (DKTK), partner site Frankfurt/Mainz; and German Cancer Research Center (DKFZ), Stiftung des öffentlichen Rechts, Im Neuenheimer Feld 280, 69120 Heidelberg, Germany; Frankfurt Cancer Institute (FCI), Georg-Speyer-Haus, Paul-Ehrlich-Straße 42-44, 60596 Frankfurt/Main, Germany; Department of Radiotherapy and Oncology, University Hospital Frankfurt, Goethe University, Theodor-Stern-Kai 7, 60590 Frankfurt/Main, Germany.'}, {'ForeName': 'Detlef', 'Initials': 'D', 'LastName': 'Imhoff', 'Affiliation': 'University Cancer Center Frankfurt (UCT), University Hospital Frankfurt, Goethe University, Theodor-Stern-Kai 7, 60590 Frankfurt/Main, Germany; German Cancer Consortium (DKTK), partner site Frankfurt/Mainz; and German Cancer Research Center (DKFZ), Stiftung des öffentlichen Rechts, Im Neuenheimer Feld 280, 69120 Heidelberg, Germany; Frankfurt Cancer Institute (FCI), Georg-Speyer-Haus, Paul-Ehrlich-Straße 42-44, 60596 Frankfurt/Main, Germany; Department of Radiotherapy and Oncology, University Hospital Frankfurt, Goethe University, Theodor-Stern-Kai 7, 60590 Frankfurt/Main, Germany.'}, {'ForeName': 'Joachim P', 'Initials': 'JP', 'LastName': 'Steinbach', 'Affiliation': 'Dr. Senckenberg Institute of Neurooncology, University Hospital Frankfurt, Goethe University, Schleusenweg 2-16, 60528 Frankfurt/Main, Germany; University Cancer Center Frankfurt (UCT), University Hospital Frankfurt, Goethe University, Theodor-Stern-Kai 7, 60590 Frankfurt/Main, Germany; German Cancer Consortium (DKTK), partner site Frankfurt/Mainz; and German Cancer Research Center (DKFZ), Stiftung des öffentlichen Rechts, Im Neuenheimer Feld 280, 69120 Heidelberg, Germany; Frankfurt Cancer Institute (FCI), Georg-Speyer-Haus, Paul-Ehrlich-Straße 42-44, 60596 Frankfurt/Main, Germany.'}, {'ForeName': 'Claus', 'Initials': 'C', 'LastName': 'Rödel', 'Affiliation': 'University Cancer Center Frankfurt (UCT), University Hospital Frankfurt, Goethe University, Theodor-Stern-Kai 7, 60590 Frankfurt/Main, Germany; German Cancer Consortium (DKTK), partner site Frankfurt/Mainz; and German Cancer Research Center (DKFZ), Stiftung des öffentlichen Rechts, Im Neuenheimer Feld 280, 69120 Heidelberg, Germany; Frankfurt Cancer Institute (FCI), Georg-Speyer-Haus, Paul-Ehrlich-Straße 42-44, 60596 Frankfurt/Main, Germany; Department of Radiotherapy and Oncology, University Hospital Frankfurt, Goethe University, Theodor-Stern-Kai 7, 60590 Frankfurt/Main, Germany.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Rieger', 'Affiliation': 'Dr. Senckenberg Institute of Neurooncology, University Hospital Frankfurt, Goethe University, Schleusenweg 2-16, 60528 Frankfurt/Main, Germany; Interdisciplinary Division of Neuro-Oncology, University Hospital Tübingen, Hoppe-Seyler-Straße 3, 72076 Tübingen, Germany.'}]","International journal of radiation oncology, biology, physics",['10.1016/j.ijrobp.2020.06.021'] 2852,32619609,"Evaluating the structural effects of intra-articular sprifermin on cartilage and non-cartilaginous tissue alterations, based on sqMRI assessment over two years.","OBJECTIVE Sprifermin (recombinant human fibroblast growth factor-18), a potential disease-modifying osteoarthritis (OA) drug, demonstrated dose-dependent effects on femorotibial cartilage thickness (by quantitative magnetic resonance imaging [MRI]) in the phase II FORWARD study. This post-hoc analysis evaluated the potential effects of sprifermin on several articular structures in the whole joint over 24 months using semi-quantitative MRI assessment. DESIGN Patients aged 40-85 years with symptomatic radiographic knee OA, Kellgren-Lawrence grade 2 or 3, and medial minimum joint space width ≥2.5 mm in the target knee were randomized (1:1:1:1:1) to receive three double-blinded, once-weekly, intra-articular injections of sprifermin 30 μg or 100 μg or placebo every 6 (q6mo) or 12 months. 1.5- or 3 Tesla MRIs were read using the Whole-Organ Magnetic Resonance Imaging Score (WORMS) system at baseline and 24 months. Change from baseline at 24 months on compartment and/or whole knee level was assessed for cartilage morphology, bone marrow lesions (BMLs), and osteophytes by delta-subregional and delta-sum (DSM) approaches. Menisci, Hoffa-synovitis, and effusion-synovitis were also evaluated for worsening. RESULTS 549 patients were included. Dose-dependent treatment effects from baseline to 24 months were observed on cartilage morphology (sprifermin 100 μg q6mo vs placebo; mean DSM (95% CI) -0.6 (-1.5, 0.2); less cartilage worsening) in the entire knee and BMLs sprifermin 100 μg q6mo vs placebo; mean DSM (95% CI) -0.2 (-0.5, 0.1) in the patellofemoral compartment. No effects over 24 months were observed on osteophytes, menisci, Hoffa-synovitis or effusion-synovitis. CONCLUSIONS Positive effects associated with sprifermin were observed for cartilage morphology changes, and BML improvement. There were no meaningful negative or positive effects associated with sprifermin in the other joint tissues examined.",2020,"No effects over 24 months were observed on osteophytes, menisci, Hoffa-synovitis or effusion-synovitis. ","['549 patients were included', 'Patients aged 40-85 years with symptomatic radiographic knee OA, Kellgren-Lawrence grade 2 or 3, and medial minimum joint space width ≥2.5 mm in the target knee']","['Sprifermin (recombinant human fibroblast growth factor-18', 'sprifermin 30 μg or 100 μg or placebo', 'placebo']","['Menisci, Hoffa-synovitis, and effusion-synovitis', 'cartilage morphology', 'osteophytes, menisci, Hoffa-synovitis or effusion-synovitis', 'cartilage morphology changes, and BML improvement', 'femorotibial cartilage thickness', 'cartilage morphology, bone marrow lesions (BMLs), and osteophytes by delta-subregional and delta-sum (DSM) approaches']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0444708', 'cui_str': 'Radiographic'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0475270', 'cui_str': 'G2 grade'}, {'cui': 'C0205098', 'cui_str': 'Medial'}, {'cui': 'C0224497', 'cui_str': 'Articular space'}, {'cui': 'C0487742', 'cui_str': 'Width'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}]","[{'cui': 'C1432638', 'cui_str': 'fibroblast growth factor 18, human'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0224498', 'cui_str': 'Meniscus structure of joint'}, {'cui': 'C0268203', 'cui_str': 'Liposynovitis prepatellaris'}, {'cui': 'C0039103', 'cui_str': 'Synovitis'}, {'cui': 'C0013687', 'cui_str': 'Effusion'}, {'cui': 'C0007301', 'cui_str': 'Cartilage tissue'}, {'cui': 'C0332437', 'cui_str': 'Associated morphology'}, {'cui': 'C0015302', 'cui_str': 'External hyperostosis'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0005953', 'cui_str': 'Bone marrow structure'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0439097', 'cui_str': 'Delta'}, {'cui': 'C1292724', 'cui_str': 'Procedural approach'}]",549.0,0.160466,"No effects over 24 months were observed on osteophytes, menisci, Hoffa-synovitis or effusion-synovitis. ","[{'ForeName': 'Frank W', 'Initials': 'FW', 'LastName': 'Roemer', 'Affiliation': 'Boston University School of Medicine, Boston, Massachusetts, USA; University of Erlangen-Nuremberg, Erlangen, Germany. Electronic address: froemer@bu.edu.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Kraines', 'Affiliation': 'EMD Serono, Inc., Billerica, Massachusetts, USA,; a business of Merck KGaA, Darmstadt, Germany.'}, {'ForeName': 'Aida', 'Initials': 'A', 'LastName': 'Aydemir', 'Affiliation': 'EMD Serono, Inc., Billerica, Massachusetts, USA,; a business of Merck KGaA, Darmstadt, Germany.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Wax', 'Affiliation': 'EMD Serono, Inc., Billerica, Massachusetts, USA,; a business of Merck KGaA, Darmstadt, Germany.'}, {'ForeName': 'Marc C', 'Initials': 'MC', 'LastName': 'Hochberg', 'Affiliation': 'University of Maryland School of Medicine, Baltimore, Maryland, USA.'}, {'ForeName': 'Michel D', 'Initials': 'MD', 'LastName': 'Crema', 'Affiliation': 'Boston University School of Medicine, Boston, Massachusetts, USA; Institute of Sports Imaging, French National Institute of Sports, Paris, France.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Guermazi', 'Affiliation': 'Boston University School of Medicine, Boston, Massachusetts, USA; Department of Radiology, VA Boston Healthcare System, West Roxbury, MA 02132, USA.'}]",Osteoarthritis and cartilage,['10.1016/j.joca.2020.05.015'] 2853,32619612,"Comparison of different incremental dose regimens of narrow-band ultraviolet B in skin types III-V: a prospective, randomized, single-blind parallel study in patients with psoriasis.",,2020,,['patients with psoriasis'],['narrow-band ultraviolet B'],[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}]","[{'cui': 'C0332463', 'cui_str': 'Narrowed structure'}, {'cui': 'C0175723', 'cui_str': 'Band'}, {'cui': 'C1532472', 'cui_str': 'Ultra-violet'}]",[],,0.0136611,,"[{'ForeName': 'Yingyuan', 'Initials': 'Y', 'LastName': 'Yu', 'Affiliation': 'Department of Dermatology, Shanghai Skin Disease Hospital, Tongji University School of Medicine, Shanghai, China, 200443; Institute of Psoriasis, Tongji University School of Medicine, Shanghai, China, 200072. Electronic address: shiyuling1973@tongji.edu.cn.'}, {'ForeName': 'Xuemei', 'Initials': 'X', 'LastName': 'Yi', 'Affiliation': 'Department of Dermatology, Shanghai Skin Disease Hospital, Tongji University School of Medicine, Shanghai, China, 200443; Institute of Psoriasis, Tongji University School of Medicine, Shanghai, China, 200072.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Department of Dermatology, Shanghai Skin Disease Hospital, Tongji University School of Medicine, Shanghai, China, 200443; Institute of Psoriasis, Tongji University School of Medicine, Shanghai, China, 200072.'}, {'ForeName': 'Ning', 'Initials': 'N', 'LastName': 'Yu', 'Affiliation': 'Department of Dermatology, Shanghai Skin Disease Hospital, Tongji University School of Medicine, Shanghai, China, 200443; Institute of Psoriasis, Tongji University School of Medicine, Shanghai, China, 200072.'}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Yu', 'Affiliation': 'Department of Dermatology, Shanghai Skin Disease Hospital, Tongji University School of Medicine, Shanghai, China, 200443; Institute of Psoriasis, Tongji University School of Medicine, Shanghai, China, 200072.'}, {'ForeName': 'Qianlian', 'Initials': 'Q', 'LastName': 'Le', 'Affiliation': 'Department of Dermatology, Shanghai Skin Disease Hospital, Tongji University School of Medicine, Shanghai, China, 200443; Institute of Psoriasis, Tongji University School of Medicine, Shanghai, China, 200072.'}, {'ForeName': 'Zeyu', 'Initials': 'Z', 'LastName': 'Chen', 'Affiliation': 'Department of Dermatology, Shanghai Skin Disease Hospital, Tongji University School of Medicine, Shanghai, China, 200443; Institute of Psoriasis, Tongji University School of Medicine, Shanghai, China, 200072.'}, {'ForeName': 'Yangfeng', 'Initials': 'Y', 'LastName': 'Ding', 'Affiliation': 'Department of Dermatology, Shanghai Skin Disease Hospital, Tongji University School of Medicine, Shanghai, China, 200443; Institute of Psoriasis, Tongji University School of Medicine, Shanghai, China, 200072.'}, {'ForeName': 'Yuling', 'Initials': 'Y', 'LastName': 'Shi', 'Affiliation': 'Department of Dermatology, Shanghai Skin Disease Hospital, Tongji University School of Medicine, Shanghai, China, 200443; Institute of Psoriasis, Tongji University School of Medicine, Shanghai, China, 200072.'}]",Journal of the American Academy of Dermatology,['10.1016/j.jaad.2020.06.993'] 2854,32619619,"A Commentary on ""Efficacy of single layered intestinal anastomosis over double layered intestinal anastomosis-an open labeled, randomized controlled trial"".",,2020,,[],['single layered intestinal anastomosis'],[],[],"[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0192711', 'cui_str': 'Anastomosis of intestine'}]",[],,0.130852,,"[{'ForeName': 'Peng', 'Initials': 'P', 'LastName': 'Liu', 'Affiliation': 'Department of Colorectal Surgery, Changhai Hospital, Second Military Medical University, 200433, Shanghai, China.'}, {'ForeName': 'Zubing', 'Initials': 'Z', 'LastName': 'Mei', 'Affiliation': 'Department of Anorectal Surgery, Shuguang Hospital, Shanghai University of Traditional Chinese Medicine, 201203, Shanghai, China; Anorectal Disease Institute of Shuguang Hospital, 201203, Shanghai, China. Electronic address: herrmayor@126.com.'}, {'ForeName': 'Guixin', 'Initials': 'G', 'LastName': 'Shen', 'Affiliation': 'Department of General Surgery, The Second Affiliated Hospital of Jiaxing University, 314000, Jiaxing, Zhejiang Province, China. Electronic address: jxeysgx1191@163.com.'}]","International journal of surgery (London, England)",['10.1016/j.ijsu.2020.06.036'] 2855,32619630,Effectiveness of a self-rehabilitation program to improve upper-extremity function after stroke in developing countries: a randomized controlled trial.,"BACKGROUND About two-thirds of stroke patients present long-term upper-limb impairment and limitations of activity, which constitutes a challenge in rehabilitation. This situation is particularly true in developing countries, where there is a need for inexpensive rehabilitation solutions. OBJECTIVE This study assessed the effectiveness of a self-rehabilitation program including uni- or bimanual functional exercises for improving upper-limb function after stroke with respect to the context in Benin, West Africa. METHODS In this single-blind randomized controlled trial, chronic stroke individuals (> 6 months post-stroke) performed a supervised home-based self-rehabilitation program for 8 weeks (intervention group); the control group did not receive any treatment. Participants were assessed before treatment (T0), at the end of treatment (T1) and 8 weeks after the end of treatment (T2). The primary outcome was the manual ability of the upper limb, assessed with ABILHAND Stroke Benin. Secondary outcomes were grip force, motor impairment (Fugl-Meyer Assessment-Upper Extremity), gross manual ability (Box and Block test, Wolf Motor Function test) and quality of life (WHOQOL-26). RESULTS We included 28 individuals in the intervention group and 31 in the control group. Adherence to the program was 83%. After 8 weeks of self-rehabilitation, individuals in the intervention group showed significantly improved manual ability and grip force as compared with the control group (p < 0.001), with effect size 0.75 and 0.24, respectively. In the intervention group, the difference in average scores was 10% between T0 and T1 and between T0 and T2. Subscores of physical and psychological quality of life were also significantly improved in the intervention group. The other variables remained unchanged. CONCLUSIONS A self-rehabilitation program was effective in improving manual ability, grip force and quality of life in individuals with stroke in Benin. More studies are needed to confirm these results in different contexts.",2020,"CONCLUSIONS A self-rehabilitation program was effective in improving manual ability, grip force and quality of life in individuals with stroke in Benin.","['after stroke in developing countries', 'chronic stroke individuals (> 6 months post-stroke', 'individuals with stroke in Benin', '28 individuals in the intervention group and 31 in the control group']","['control group did not receive any treatment', 'self-rehabilitation program', 'self-rehabilitation program including uni- or bimanual functional exercises', 'supervised home-based self-rehabilitation program']","['manual ability of the upper limb, assessed with ABILHAND Stroke Benin', 'upper-extremity function', 'Subscores of physical and psychological quality of life', 'average scores', 'manual ability, grip force and quality of life', 'grip force, motor impairment (Fugl-Meyer Assessment-Upper Extremity), gross manual ability (Box and Block test, Wolf Motor Function test) and quality of life (WHOQOL-26', 'manual ability and grip force']","[{'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0011750', 'cui_str': 'Less-Developed Countries'}, {'cui': 'C3536593', 'cui_str': 'Chronic cerebrovascular accident'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0005005', 'cui_str': 'Benin'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1299585', 'cui_str': 'Does not'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C3853222', 'cui_str': 'Sea urchin - dietary'}, {'cui': 'C0454284', 'cui_str': 'Functional exercises'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}]","[{'cui': 'C0024763', 'cui_str': 'Manuals as Topic'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C1140618', 'cui_str': 'Upper limb structure'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0005005', 'cui_str': 'Benin'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0220843', 'cui_str': 'Grasp'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0221099', 'cui_str': 'Impaired'}, {'cui': 'C0439806', 'cui_str': 'Gross'}, {'cui': 'C0006080', 'cui_str': 'Boxing'}, {'cui': 'C0028778', 'cui_str': 'Obstruction'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0325001', 'cui_str': 'Wolf'}, {'cui': 'C0234130', 'cui_str': 'Motor function'}]",,0.0722415,"CONCLUSIONS A self-rehabilitation program was effective in improving manual ability, grip force and quality of life in individuals with stroke in Benin.","[{'ForeName': 'Ditouah Didier Niama', 'Initials': 'DDN', 'LastName': 'Natta', 'Affiliation': 'National University Hospital of Cotonou, Physical medicine and Rehabilitation Department, Cotonou, Benin; NMSK lab, Institut de Recherche Expérimentale et Clinique (IREC), UCLouvain, Brussels, Belgium.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Lejeune', 'Affiliation': 'NMSK lab, Institut de Recherche Expérimentale et Clinique (IREC), UCLouvain, Brussels, Belgium; Physical Medicine and Rehabilitation Department, Cliniques universitaires Saint-Luc, Brussels, Belgium; Louvain Bionics, UCLouvain, Louvain-La-Neuve, Belgium.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Detrembleur', 'Affiliation': 'NMSK lab, Institut de Recherche Expérimentale et Clinique (IREC), UCLouvain, Brussels, Belgium; Louvain Bionics, UCLouvain, Louvain-La-Neuve, Belgium.'}, {'ForeName': 'Berenice', 'Initials': 'B', 'LastName': 'Yarou', 'Affiliation': 'National University Hospital of Cotonou, Physical medicine and Rehabilitation Department, Cotonou, Benin.'}, {'ForeName': 'Emmanuel S', 'Initials': 'ES', 'LastName': 'Sogbossi', 'Affiliation': 'National University Hospital of Cotonou, Physical medicine and Rehabilitation Department, Cotonou, Benin.'}, {'ForeName': 'Etienne', 'Initials': 'E', 'LastName': 'Alagnidé', 'Affiliation': 'National University Hospital of Cotonou, Physical medicine and Rehabilitation Department, Cotonou, Benin.'}, {'ForeName': 'Toussaint', 'Initials': 'T', 'LastName': 'Kpadonou', 'Affiliation': 'National University Hospital of Cotonou, Physical medicine and Rehabilitation Department, Cotonou, Benin.'}, {'ForeName': 'Clara', 'Initials': 'C', 'LastName': 'Selves', 'Affiliation': 'NMSK lab, Institut de Recherche Expérimentale et Clinique (IREC), UCLouvain, Brussels, Belgium; Physical Medicine and Rehabilitation Department, Cliniques universitaires Saint-Luc, Brussels, Belgium; Louvain Bionics, UCLouvain, Louvain-La-Neuve, Belgium.'}, {'ForeName': 'Gaëtan', 'Initials': 'G', 'LastName': 'Stoquart', 'Affiliation': 'NMSK lab, Institut de Recherche Expérimentale et Clinique (IREC), UCLouvain, Brussels, Belgium; Physical Medicine and Rehabilitation Department, Cliniques universitaires Saint-Luc, Brussels, Belgium; Louvain Bionics, UCLouvain, Louvain-La-Neuve, Belgium. Electronic address: gaetan.stoquart@uclouvain.be.'}]",Annals of physical and rehabilitation medicine,['10.1016/j.rehab.2020.03.017'] 2856,32619715,Outcome of photodynamic therapy on orthodontic leveling and alignment of mandibular anterior segment: A controlled clinical trial.,"BACKGROUND Photodynamic therapy (PDT) is non-invasive approach that has drawn attention to accelerate orthodontic tooth movement (OTM). However, no studies have been published that evaluates the outcome of PDT on orthodontic leveling and alignment. Therefore, the present study aimed to evaluate outcome of PDT on orthodontic leveling and alignment of mandibular anterior segment. MATERIALS AND METHODS Thirty patients (18 females and 12 males) were included who had moderate mandibular crowding with average age was 19.23 ± 3.1 years. They were randomly divided into a control group without PDT intervention and a laser group. All patients followed non-extraction approach using one category of fixed appliance and matching NiTi archwire sequence for 3 months. In PDT group, methylene blue mediated gallium aluminum arsenide laser was applied with 635 nm, 6.5 J/cm 2 , for 10 seconds at 10 points (0.2 J/point) started immediately after first wire then at days 3,7,14 of first month and repeated for additional 2 months. Relief of crowding was assessed by Little`s irregularity index (LII) scores after 4, 8, and 12 weeks through scanned 3-dimensional models via a software. RESULTS Both groups showed improvements in mandibular crowding as evidenced by significant decreases (p ≤ 0.001) in LII scores during all observation intervals with no significant differences (p > 0.05). Moreover, the alignment`s rate showed no significant differences between groups. CONCLUSION PDT produced a negligible effect concerning alignment of crowded mandibular anterior teeth. Besides, OTM's rate at different observation intervals showed an equivalent pattern either with or without PDT.",2020,Both groups showed improvements in mandibular crowding as evidenced by significant decreases (p ≤ 0.001) in LII scores during all observation intervals with no significant differences (p > 0.05).,['Thirty patients (18 females and 12 males) were included who had moderate mandibular crowding with average age was 19.23\u2009±\u20093.1 years'],"['Photodynamic therapy (PDT', 'methylene blue mediated gallium aluminum arsenide laser', 'photodynamic therapy', 'PDT', 'control group without PDT intervention and a laser group']","[""OTM's rate"", 'LII scores', 'orthodontic leveling and alignment of mandibular anterior segment', 'Little`s irregularity index (LII) scores', 'mandibular crowding']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205081', 'cui_str': 'Moderate'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0010383', 'cui_str': 'Crowding'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C4517683', 'cui_str': '3.1'}, {'cui': 'C0439234', 'cui_str': 'year'}]","[{'cui': 'C0031740', 'cui_str': 'Photochemotherapy'}, {'cui': 'C0025746', 'cui_str': 'Methylene blue'}, {'cui': 'C0086597', 'cui_str': 'Mediate'}, {'cui': 'C1269095', 'cui_str': 'Gallium aluminum arsenide semiconductor laser device'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0023089', 'cui_str': 'Laser device'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0040446', 'cui_str': 'Orthodontic Tooth Movement'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0332276', 'cui_str': 'Orthodontic'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0003153', 'cui_str': 'Anterior eyeball segment structure'}]",,0.0382065,Both groups showed improvements in mandibular crowding as evidenced by significant decreases (p ≤ 0.001) in LII scores during all observation intervals with no significant differences (p > 0.05).,"[{'ForeName': 'Tharwat Osman', 'Initials': 'TO', 'LastName': 'El Shehawy', 'Affiliation': 'Department of Orthodontics, Faculty of Dental Medicine (Boys), Al-Azhar University, Cairo, Egypt.'}, {'ForeName': 'Farouk Ahmed', 'Initials': 'FA', 'LastName': 'Hussein', 'Affiliation': 'Department of Orthodontics, Faculty of Dental Medicine (Boys), Al-Azhar University, Cairo, Egypt. Electronic address: fahmedhusseinaau@gmail.com.'}, {'ForeName': 'Akram Abbbas', 'Initials': 'AA', 'LastName': 'Ei Awady', 'Affiliation': 'Department of Oral Medicine & Diagnosis &Radiology, Faculty of Dental Medicine (Boys), Al-Azhar University, Cairo, Egypt.'}]",Photodiagnosis and photodynamic therapy,['10.1016/j.pdpdt.2020.101903'] 2857,32619739,Transvenous Phrenic Nerve Stimulation for Central Sleep Apnea is Safe and Effective in Patients with Concomitant Cardiac Devices.,"BACKGROUND Central sleep apnea is common in heart failure patients. Transvenous phrenic nerve stimulation (TPNS) requires placing a lead to stimulate the phrenic nerve and activate the diaphragm. Data are lacking concerning the safety and efficacy of TPNS in patients with concomitant cardiovascular implantable electronic devices (CIEDs). OBJECTIVE The objective is to report the safety and efficacy of TPNS in patients with concomitant CIEDs. METHODS In the remedē System Pivotal Trial, 151 patients underwent TPNS device implant. This analysis compared patients with concomitant CIEDs to those without with respect to safety, implant metrics and efficacy of TPNS. Safety was assessed using incidence of adverse events and device-device interactions. A detailed interaction protocol was followed. Implant metrics included overall TPNS implantation success. Efficacy endpoints included changes in the apnea-hypopnea index (AHI) and quality of life. RESULTS Of 151 patients, 64 (42%) had a concomitant CIED. There were no significant differences between the groups with respect to safety. There were 4 CIED oversensing events in 3 patients leading to one inappropriate defibrillator shock and delivery of anti-tachycardia pacing. There was no difference in efficacy between the CIED and non-CIED subgroups receiving TPNS, with both having similar percentages of patients who achieved ≥ 50% reduction in AHI and quality of life improvement. CONCLUSION Concomitant CIED and TPNS therapy is safe. The presence of a concomitant CIED did not appear to impact implant metrics, implantation success and TPNS efficacy. A detailed interaction protocol should be followed to minimize the incidence of device-device interaction.",2020,There were no significant differences between the groups with respect to safety.,"['patients with concomitant CIEDs', 'heart failure patients', 'patients with concomitant cardiovascular implantable electronic devices (CIEDs', '151 patients underwent TPNS device implant', 'Of 151 patients, 64 (42%) had a concomitant CIED', 'Patients with Concomitant Cardiac Devices']","['Transvenous Phrenic Nerve Stimulation', 'Transvenous phrenic nerve stimulation (TPNS', 'Concomitant CIED and TPNS therapy', 'TPNS']","['apnea-hypopnea index (AHI) and quality of life', 'overall TPNS implantation success', 'efficacy', 'AHI and quality of life improvement', 'adverse events and device-device interactions']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0013850', 'cui_str': 'Electronic'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0522521', 'cui_str': 'Transvenous approach'}, {'cui': 'C0031774', 'cui_str': 'Structure of phrenic nerve'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}]","[{'cui': 'C0522521', 'cui_str': 'Transvenous approach'}, {'cui': 'C0031774', 'cui_str': 'Structure of phrenic nerve'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C2111846', 'cui_str': 'Apnea Hypopnea Index'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0522521', 'cui_str': 'Transvenous approach'}, {'cui': 'C0031774', 'cui_str': 'Structure of phrenic nerve'}, {'cui': 'C1292856', 'cui_str': 'Stimulation'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0853893', 'cui_str': 'Device interaction'}]",151.0,0.0557761,There were no significant differences between the groups with respect to safety.,"[{'ForeName': 'Hemal M', 'Initials': 'HM', 'LastName': 'Nayak', 'Affiliation': 'Center for Arrhythmia Care, Heart and Vascular Center, The University of Chicago Pritzker School of Medicine, Chicago, Illinois. Electronic address: hnayak@uchicago.edu.'}, {'ForeName': 'Raj', 'Initials': 'R', 'LastName': 'Patel', 'Affiliation': 'Center for Arrhythmia Care, Heart and Vascular Center, The University of Chicago Pritzker School of Medicine, Chicago, Illinois.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'McKane', 'Affiliation': 'Respicardia, Inc., Minnetonka, Minnesota.'}, {'ForeName': 'Kristofer J', 'Initials': 'KJ', 'LastName': 'James', 'Affiliation': 'Respicardia, Inc., Minnetonka, Minnesota.'}, {'ForeName': 'Timothy E', 'Initials': 'TE', 'LastName': 'Meyer', 'Affiliation': 'Respicardia, Inc., Minnetonka, Minnesota.'}, {'ForeName': 'Robin E', 'Initials': 'RE', 'LastName': 'Germany', 'Affiliation': 'Respicardia, Inc., Minnetonka, Minnesota.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Stellbrink', 'Affiliation': 'Bielefeld Medical Center, Bielefeld, Germany.'}, {'ForeName': 'Maria Rosa', 'Initials': 'MR', 'LastName': 'Costanzo', 'Affiliation': 'Advocate Heart Institute, Naperville, Illinois.'}, {'ForeName': 'Ralph', 'Initials': 'R', 'LastName': 'Augostini', 'Affiliation': 'The Ohio State University Wexner Medical Center, Columbus, Ohio.'}]",Heart rhythm,['10.1016/j.hrthm.2020.06.023'] 2858,32619792,Human urine 1 H NMR metabolomics reveals alterations of the protein and carbohydrate metabolism when comparing habitual Average Danish diet vs. healthy New Nordic diet.,"OBJECTIVES The aim of this study was to investigate the alteration of the human urine metabolome by means of diet and to compare the metabolic effects of the nutritionally healthy New Nordic Diet (NND) with an Average Danish Diet (ADD). The NND was designed a decade ago by scientists and chefs, based on local and sustainable foods, including fish, shellfish, vegetables, roots, fruit, and berries. The NND has been proven to lower blood pressure, reduce glycemia, and lead to weight loss. METHODS The human urine metabolome was measured by untargeted proton nuclear magnetic resonance spectroscopy in samples from 142 centrally obese Danes (20-66 years old), randomized to consume the ADD or the NND. The resulting metabolomics data was processed and analyzed using advanced multivariate data analysis methods to reveal effects related to the design factors, including diet, season, sex, and changes in body weight. RESULTS Exploration of the nuclear magnetic resonance profiles revealed unique metabolite markers reflecting changes in protein and carbohydrate metabolism between the two diets. Glycine betaine, glucose, trimethylamine N-oxide and creatinine were increased in urine of the individuals following the NND compared with the ADD population, whereas relative concentrations of tartrate, dimethyl sulfone, and propylene glycol were decreased. Propylene glycol had a strong association with the homeostatic model assessment for insulin resistance in the NND group. The food intake biomarkers found in this study confirm the importance of these as tools for nutritional research. CONCLUSIONS Findings from this study provided new insights into the effects of a healthy diet on glycemia, reduction of inflammation, and weight loss among obese individuals, and alteration of the gut microbiota metabolism.",2020,"Glycine betaine, glucose, trimethylamine N-oxide and creatinine were increased in urine of the individuals following the NND compared with the ADD population, whereas relative concentrations of tartrate, dimethyl sulfone, and propylene glycol were decreased.",['in samples from 142 centrally obese Danes (20-66 years old'],"['nutritionally healthy New Nordic Diet (NND) with an Average Danish Diet (ADD', 'Propylene glycol', 'untargeted proton nuclear magnetic resonance spectroscopy']","['relative concentrations of tartrate, dimethyl sulfone, and propylene glycol', 'glycemia, reduction of inflammation, and weight loss', 'Glycine betaine, glucose, trimethylamine N-oxide and creatinine']","[{'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0337800', 'cui_str': 'Danes'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0010969', 'cui_str': 'Danish language'}, {'cui': 'C0033437', 'cui_str': 'Propanediols'}, {'cui': 'C0033727', 'cui_str': 'Proton'}, {'cui': 'C0877853', 'cui_str': 'Spectroscopy, NMR'}]","[{'cui': 'C0080103', 'cui_str': 'Relative'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0039328', 'cui_str': 'Tartrates'}, {'cui': 'C0058231', 'cui_str': 'methylsulfonylmethane'}, {'cui': 'C0033437', 'cui_str': 'Propanediols'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C1262477', 'cui_str': 'Weight decreased'}, {'cui': 'C0005304', 'cui_str': 'Betaine'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0077194', 'cui_str': 'trimethyloxamine'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}]",142.0,0.027383,"Glycine betaine, glucose, trimethylamine N-oxide and creatinine were increased in urine of the individuals following the NND compared with the ADD population, whereas relative concentrations of tartrate, dimethyl sulfone, and propylene glycol were decreased.","[{'ForeName': 'Alessia', 'Initials': 'A', 'LastName': 'Trimigno', 'Affiliation': 'Department of Food Science, Faculty of Science, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Bekzod', 'Initials': 'B', 'LastName': 'Khakimov', 'Affiliation': 'Department of Food Science, Faculty of Science, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Savorani', 'Affiliation': 'Department of Applied Science and Technology, Polytechnic of Turin, Turin, Italy.'}, {'ForeName': 'Sanne Kellebjerg', 'Initials': 'SK', 'LastName': 'Poulsen', 'Affiliation': 'Department of Nutrition Exercise and Sports, Faculty of Science, University of Copenhagen, Copenhagen, Denmark; Steno Diabetes Center Copenhagen, Gentofte, Denmark.'}, {'ForeName': 'Arne', 'Initials': 'A', 'LastName': 'Astrup', 'Affiliation': 'Department of Nutrition Exercise and Sports, Faculty of Science, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Lars O', 'Initials': 'LO', 'LastName': 'Dragsted', 'Affiliation': 'Department of Nutrition Exercise and Sports, Faculty of Science, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Søren Balling', 'Initials': 'SB', 'LastName': 'Engelsen', 'Affiliation': 'Department of Food Science, Faculty of Science, University of Copenhagen, Copenhagen, Denmark. Electronic address: se@food.ku.dk.'}]","Nutrition (Burbank, Los Angeles County, Calif.)",['10.1016/j.nut.2020.110867'] 2859,32619832,Definitive chemoradiotherapy plus cetuximab for cancer in the oesophagus or gastro-oesophageal junction.,"BACKGROUND Chemoradiotherapy is standard treatment for localized oesophageal cancer unsuitable for surgery. We aimed to evaluate the efficacy of cetuximab in combination with chemoradiotherapy. METHODS This non-randomised multicentre phase II trial recruited patients aged 18-75 with WHO performance status 0-2 having squamous cell carcinoma or adenocarcinoma in the oesophagus or gastro-oesophageal junction, T2-4, N0-3, M0 not suitable for surgery. Chemotherapy was three 21-day cycles of fluorouracil 750 mg/m2 D1-5 and oxaliplatin D1 (cycle 1:130mg/m 2, cycle 2-3:85 mg/m 2). Radiotherapy was 50Gy in 2Gy/fraction, 5 days a week, concurrent with cycle 2 and 3 and weekly cetuximab. The primary objective was loco-regional control at one year. RESULTS 52 patients were included. 51 were eligible for toxicity and survival analysis and 46 for recurrence analysis. Full radiotherapy dose was delivered to 80%, 75% received all three cycles of chemotherapy and 75% received four or more doses of cetuximab. The most common related grade III-IV adverse events were gastro-intestinal(16), hypersensitivity(6) and infection(5). There were two drug-related deaths. Within six months from the end of treatment, six patients died from complications from fistulas. The loco-regional control rate at one year was 47.3%(95%CI 30.9%-62.1%). Overall survival at three years was 29.1%(95% CI 17.4-41.9%). CONCLUSIONS Oxaliplatin and fluorouracil given concurrent with radiotherapy and cetuximab had an acceptable safety profile and showed a clinical response in patients with locoregionally advanced oesophageal cancer unsuitable for surgery. However, the primary end-point was not met, and the addition of cetuximab to definitive chemoradiotherapy cannot be recommended.",2020,"Overall survival at three years was 29.1%(95% CI 17.4-41.9%). ","['localized oesophageal cancer unsuitable for surgery', 'cancer in the oesophagus or gastro-oesophageal junction', 'patients with locoregionally advanced oesophageal cancer unsuitable for surgery', 'patients aged 18-75 with WHO performance status 0-2 having squamous cell carcinoma or adenocarcinoma in the oesophagus or gastro-oesophageal junction, T2-4, N0-3, M0 not suitable for surgery', '52 patients were included']","['radiotherapy and cetuximab', 'Chemotherapy', 'Definitive chemoradiotherapy plus cetuximab', 'Oxaliplatin and fluorouracil', 'Full radiotherapy', 'cetuximab', 'Chemoradiotherapy', 'fluorouracil 750 mg/m2 D1-5 and oxaliplatin D1 (cycle 1:130mg', 'Radiotherapy']","['toxicity and survival analysis', 'Overall survival', 'loco-regional control at one year', 'loco-regional control rate']","[{'cui': 'C0392752', 'cui_str': 'Localized'}, {'cui': 'C0546837', 'cui_str': 'Malignant tumor of esophagus'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0014876', 'cui_str': 'Esophageal structure'}, {'cui': 'C0014871', 'cui_str': 'Cardioesophageal junction structure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0007137', 'cui_str': 'Squamous cell carcinoma'}, {'cui': 'C0001418', 'cui_str': 'Adenocarcinoma'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0995188', 'cui_str': 'cetuximab'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0443196', 'cui_str': 'Definitive'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C4517868', 'cui_str': '750'}, {'cui': 'C1319266', 'cui_str': 'mg/sq.m'}]","[{'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0038953', 'cui_str': 'Analysis, Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4082117', 'cui_str': 'One year'}]",52.0,0.16028,"Overall survival at three years was 29.1%(95% CI 17.4-41.9%). ","[{'ForeName': 'Gabriella Alexandersson', 'Initials': 'GA', 'LastName': 'von Döbeln', 'Affiliation': 'Theme Cancer, Karolinska University Hospital, Stockholm, Sweden. Electronic address: gabriella.alexandersson-vondobeln@sll.se.'}, {'ForeName': 'Gunnar', 'Initials': 'G', 'LastName': 'Wagenius', 'Affiliation': 'Theme Cancer, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Holtved', 'Affiliation': 'Department of Oncology, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Anne-Birgitte', 'Initials': 'AB', 'LastName': 'Jacobsen', 'Affiliation': 'Department of Oncology, Oslo University hospital, Oslo, Norway.'}, {'ForeName': 'Magnus', 'Initials': 'M', 'LastName': 'Nilsson', 'Affiliation': 'Department of Clinical Sciences Intervention and Technology Karolinska Institutet Division of Upper Abdominal Cancer, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Jingru', 'Initials': 'J', 'LastName': 'Yu', 'Affiliation': 'Department of Medical Epidemiology and Biostatistics, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Lene', 'Initials': 'L', 'LastName': 'Baeksgaard', 'Affiliation': 'Department of Oncology, Rigshospitalet, Copenhagen, Denmark.'}]",Cancer treatment and research communications,['10.1016/j.ctarc.2020.100187'] 2860,32619848,The influence of placebo administration on the first- night effect in patients with insomnia disorder.,"OBJECTIVE We aimed to investigate the effects of placebo on the first-night effect (FNE) in insomniacs. METHODS In sum, 36 patients with insomnia disorder who met the DSM-5 criteria were enrolled in this study. Sixteen patients with insomnia disorder were given two days of placebo intervention (placebo-administration group, PL). Twenty patients with insomnia disorder (drug-free group, DF) were not given any interventions. All participants underwent two consecutive nights of polysomnographic (PSG) testing in the sleep laboratory. Sleep diaries were recorded during one week at home before the PSG nights and on two subsequent nights. RESULTS The results demonstrated that compared with the DF group, sleep onset latency (SOL), time in bed (TIB) and wake after sleep onset (WASO) significantly increased and sleep efficiency (SE) significantly decreased in the first sleep lab night in the PL group (all p < 0.05). Moreover, compared with the second night, significant differences were observed in lower self-reported total sleep time (TST) and more subjective WASO during the first night in the PL group (all p < 0.05). However, no significant difference was found in the duration and percentage of N1, N2, N3 and REM between the two groups. CONCLUSION In patients with insomnia disorder, placebo administration may increase the occurrence of worse sleep without causing a change in the duration and percentage of N1, N2, N3 and REM on the first sleep lab night. In some cases, a placebo may not serve as treatment but may result in a nocebo effect.",2020,"However, no significant difference was found in the duration and percentage of N1, N2, N3 and REM between the two groups. ","['patients with insomnia disorder', 'Twenty patients with insomnia disorder (drug-free group, DF', 'All participants underwent two consecutive nights of polysomnographic (PSG) testing in the sleep laboratory', '36 patients with insomnia disorder who met the DSM-5 criteria', 'insomniacs', 'Sixteen patients with insomnia disorder']","['placebo intervention (placebo-administration group, PL', 'placebo']","['duration and percentage of N1, N2, N3 and REM', 'Sleep diaries', 'occurrence of worse sleep', 'lower self-reported total sleep time (TST) and more subjective WASO', 'sleep onset latency (SOL), time in bed (TIB) and wake after sleep onset (WASO', 'sleep efficiency (SE']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0917801', 'cui_str': 'Insomnia'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0240526', 'cui_str': 'Night time'}, {'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C1137105', 'cui_str': 'DSM-V'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C3715157', 'cui_str': '16'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0560134', 'cui_str': 'rem'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0376660', 'cui_str': 'Diaries'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0442696', 'cui_str': 'Waking'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C4505222', 'cui_str': 'Sleep Onset Latency'}, {'cui': 'C0004914', 'cui_str': 'Bedding'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}]",36.0,0.0242769,"However, no significant difference was found in the duration and percentage of N1, N2, N3 and REM between the two groups. ","[{'ForeName': 'Sifan', 'Initials': 'S', 'LastName': 'Hu', 'Affiliation': 'Peking University Sixth Hospital, Peking University Institute of Mental Health, NHC Key Laboratory of Mental Health (Peking University), National Clinical Research Center for Mental Disorders (Peking University Sixth Hospital), Peking University, Beijing, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Peking University Sixth Hospital, Peking University Institute of Mental Health, NHC Key Laboratory of Mental Health (Peking University), National Clinical Research Center for Mental Disorders (Peking University Sixth Hospital), Peking University, Beijing, China.'}, {'ForeName': 'Yuezhen', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Neuropsychiatry, Behavioral Neurology and Sleep Center, Beijing Tian Tan Hospital, Capital Medical University, Beijing, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Shao', 'Affiliation': 'Peking University Sixth Hospital, Peking University Institute of Mental Health, NHC Key Laboratory of Mental Health (Peking University), National Clinical Research Center for Mental Disorders (Peking University Sixth Hospital), Peking University, Beijing, China.'}, {'ForeName': 'Xiaoxia', 'Initials': 'X', 'LastName': 'Zhao', 'Affiliation': 'Peking University Sixth Hospital, Peking University Institute of Mental Health, NHC Key Laboratory of Mental Health (Peking University), National Clinical Research Center for Mental Disorders (Peking University Sixth Hospital), Peking University, Beijing, China.'}, {'ForeName': 'Sijia', 'Initials': 'S', 'LastName': 'Lou', 'Affiliation': 'Peking University Sixth Hospital, Peking University Institute of Mental Health, NHC Key Laboratory of Mental Health (Peking University), National Clinical Research Center for Mental Disorders (Peking University Sixth Hospital), Peking University, Beijing, China.'}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Pan', 'Affiliation': 'Sleep Medicine Center, Suzhou Guangji Hospital, The Affiliated Guangji Hospital of Soochow University, Suzhou, China.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Yao', 'Affiliation': 'Department of Physiology, College of Basic Medicine, Inner Mongolia Medical University, Hohhot, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Sun', 'Affiliation': 'Peking University Sixth Hospital, Peking University Institute of Mental Health, NHC Key Laboratory of Mental Health (Peking University), National Clinical Research Center for Mental Disorders (Peking University Sixth Hospital), Peking University, Beijing, China.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Lu', 'Affiliation': 'Peking University Sixth Hospital, Peking University Institute of Mental Health, NHC Key Laboratory of Mental Health (Peking University), National Clinical Research Center for Mental Disorders (Peking University Sixth Hospital), Peking University, Beijing, China.'}, {'ForeName': 'Xiangdong', 'Initials': 'X', 'LastName': 'Tang', 'Affiliation': 'Sleep Medicine Center, Department of Respiratory and Critical Care Medicine, Translational Neuroscience Center, State Key Laboratory, West China Hospital, Sichuan University, Chengdu, China. Electronic address: 2372564613@qq.com.'}, {'ForeName': 'Hongqiang', 'Initials': 'H', 'LastName': 'Sun', 'Affiliation': 'Peking University Sixth Hospital, Peking University Institute of Mental Health, NHC Key Laboratory of Mental Health (Peking University), National Clinical Research Center for Mental Disorders (Peking University Sixth Hospital), Peking University, Beijing, China. Electronic address: sunhq@bjmu.edu.cn.'}]",Sleep medicine,['10.1016/j.sleep.2020.03.002'] 2861,32619868,Extended-release naltrexone versus buprenorphine-naloxone to treat opioid use disorder among black adults.,"Few studies examine the effectiveness of treatments for opioid use disorder (OUD) among Black individuals despite recent evidence suggesting opioid overdose death rates are, in some cases, highest and increasing at a faster rate among Black people compared to other racial/ethnic groups. This secondary analysis study investigated treatment preference, retention, and relapse rates amongst a subgroup of 73 Black participants with OUD (81% male, mean age 39.05, SD = 11.80) participating in a 24-week multisite randomized clinical trial (""X:BOT"") comparing the effectiveness of extended-release naltrexone (XR-NTX) and sublingual buprenorphine-naloxone (BUP-NX) between 2014 and 2017. Chi-square analyses were used to investigate treatment preference assessed at baseline, and logistic regression analyses were used to investigate differences in the odds of retention and relapse assessed over the 24-week course of treatment between treatment groups. Our findings suggest no differences in preference for XR-NTX versus BUP-NX. However, similar to the parent trial, there was an induction hurdle such that only 59.5% of those randomized to XR-NTX successfully initiated medication compared to 91.6% of those randomized to BUP-NX (OR = 0.13, 95% CI = 0.04, 0.52). No significant differences were found in treatment retention (intention-to-treat: OR = 1.19, 95% CI = 0.43, 3.28; per-protocol [i.e., those who initiated medication]: OR = 0.60, 95% CI = 0.20, 1.82) or relapse rates between treatment groups (intention-to-treat: OR = 1.53, 95% CI = 0.57, 4.13; per-protocol: OR = 0.69, 95% CI = 0.23, 2.06). Although there is a significant initiation hurdle with XR-NTX, once inducted, both medications appear similar in effectiveness, but as in the main study, dropout rates were high. Future research is needed on how to improve adherence.",2020,"No significant differences were found in treatment retention (intention-to-treat: OR = 1.19, 95% CI = 0.43, 3.28; per-protocol","['black adults', '73 Black participants with OUD (81% male, mean age 39.05, SD\xa0=\xa011.80) participating']","['extended-release naltrexone (XR-NTX) and sublingual buprenorphine-naloxone (BUP-NX', 'naltrexone', 'buprenorphine-naloxone']",['relapse rates'],"[{'cui': 'C0005680', 'cui_str': 'Black - ethnic group'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4324621', 'cui_str': 'Opioid use disorder'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C0231448', 'cui_str': 'Extension'}, {'cui': 'C0030685', 'cui_str': 'Patient discharge'}, {'cui': 'C0027360', 'cui_str': 'Naltrexone'}, {'cui': 'C0285526', 'cui_str': 'N-telopeptide'}, {'cui': 'C0001565', 'cui_str': 'Sublingual route'}, {'cui': 'C1169989', 'cui_str': 'Buprenorphine- and naloxone-containing product'}]","[{'cui': 'C0035020', 'cui_str': 'Relapse phase'}]",73.0,0.101327,"No significant differences were found in treatment retention (intention-to-treat: OR = 1.19, 95% CI = 0.43, 3.28; per-protocol","[{'ForeName': 'Angela M', 'Initials': 'AM', 'LastName': 'Haeny', 'Affiliation': 'Yale School of Medicine, Department of Psychiatry, 34 Park St., New Haven, CT 06511, United States. Electronic address: angela.haeny@yale.edu.'}, {'ForeName': 'LaTrice', 'Initials': 'L', 'LastName': 'Montgomery', 'Affiliation': 'University of Cincinnati, Department of Psychiatry and Behavioral Neuroscience, 3131 Harvey Avenue., Cincinnati, OH 45229, United States.'}, {'ForeName': 'A Kathleen', 'Initials': 'AK', 'LastName': 'Burlew', 'Affiliation': 'University of Cincinnati, Department of Psychology, 2600 Clifton Ave., Cincinnati, OH 45221, United States.'}, {'ForeName': 'Aimee N C', 'Initials': 'ANC', 'LastName': 'Campbell', 'Affiliation': 'Columbia University Irving Medical Center, Department of Psychiatry and New York State Psychiatric Institute, 1051 Riverside Dr., New York, NY 10032, United States.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Scodes', 'Affiliation': 'Columbia University Irving Medical Center, Department of Psychiatry and New York State Psychiatric Institute, 1051 Riverside Dr., New York, NY 10032, United States.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Pavlicova', 'Affiliation': 'Columbia University Irving Medical Center, Department of Psychiatry and New York State Psychiatric Institute, 1051 Riverside Dr., New York, NY 10032, United States.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Rotrosen', 'Affiliation': 'New York University Grossman School of Medicine, One Park Ave., New York, NY 10016, United States.'}, {'ForeName': 'Edward', 'Initials': 'E', 'LastName': 'Nunes', 'Affiliation': 'Columbia University Irving Medical Center, Department of Psychiatry and New York State Psychiatric Institute, 1051 Riverside Dr., New York, NY 10032, United States.'}]",Addictive behaviors,['10.1016/j.addbeh.2020.106514'] 2862,32620020,Nasogastric versus Orogastric Bolus Tube Feeding in Preterm Infants: Pilot Randomized Clinical Trial.,"OBJECTIVE According to the most recent metanalysis, the best way to establish safe enteral feeding in preterm babies using nasogastric or orogastric tubes is still not well understood. This study aimed to determine the effects of bolus nasal tubes versus bolus orogastric tubes on the time required to reach full enteral feeding in preterm infants, as well as to compare the incidence rates of adverse events including nonintentional removal or displacement of the feeding tube, aspiration pneumonia/pneumonitis, apnea, necrotizing enterocolitis, gastric residual, and growth parameters between the studied cohort of preterm infants. STUDY DESIGN We conducted an unblinded pilot randomized clinical trial on hemodynamically stable preterm infants (>28 weeks) recruited from level 2 neonatal intensive care unit at Mansoura University Children's Hospital from June 2015 to May 2017. RESULTS Our study included 98 stable preterm infants with mean gestational age (orogastric group: 33.27 ± 1.08, nasogastric group: 33.32 ± 1.57) and mean birthweight (orogastric group: 1,753.3 ± 414.51, nasogastric group: 1,859.6 ± 307.05). Preterm infants who were fed via bolus nasogastric tube achieved full enteral feeding in a significantly shorter duration compared with the infants fed via bolus orogastric tube. The incidence rates of aspiration and feeding tube displacement were significantly higher in the bolus orogastric tube group compared with the bolus nasogastric tube group. There was no difference in the incidence rates of apnea, necrotizing enterocolitis, bradycardia, oxygen desaturation, and gastric residual in both groups. CONCLUSION Preterm infants without any respiratory support receiving bolus nasogastric tube feeding achieved full enteral feeding significantly sooner than those receiving bolus orogastric tube feeding. Additionally, bolus nasogastric tube feeding had a lower incidence of aspiration, tube displacement, and the infants regained birthweight more quickly than those receiving orogastric tube feeding. KEY POINTS · Preterm babies achieve full entral feeds sooner by nasogastric tubes than orogastric tubes.. · Incidence of nasogastric tube displacement and aspiration is less than orogastric tube.. · Infants on nasogastric tubes feeding regain birth weight quicker than those fed by orogastric tubes..",2020,"There was no difference in the incidence rates of apnea, necrotizing enterocolitis, bradycardia, oxygen desaturation, and gastric residual in both groups. ","[""hemodynamically stable preterm infants (>28 weeks) recruited from level 2 neonatal intensive care unit at Mansoura University Children's Hospital from June 2015 to May 2017"", 'preterm infants', '98 stable preterm infants with mean gestational age (orogastric group: 33.27\u2009±\u20091.08, nasogastric group: 33.32\u2009±\u20091.57) and mean birthweight (orogastric group: 1,753.3\u2009±\u2009414.51, nasogastric group: 1,859.6\u2009±\u2009307.05', 'Preterm Infants', 'preterm babies', 'Preterm infants']","['bolus nasal tubes versus bolus orogastric tubes', 'Nasogastric versus Orogastric Bolus Tube Feeding']","['incidence rates of aspiration and feeding tube displacement', 'full enteral feeding', 'incidence rates of apnea, necrotizing enterocolitis, bradycardia, oxygen desaturation, and gastric residual', 'nonintentional removal or displacement of the feeding tube, aspiration pneumonia/pneumonitis, apnea, necrotizing enterocolitis, gastric residual, and growth parameters']","[{'cui': 'C0578150', 'cui_str': 'Hemodynamically stable'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0456948', 'cui_str': 'Level 2'}, {'cui': 'C0021709', 'cui_str': 'Neonatal intensive care unit'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0020017', 'cui_str': ""Children's hospital""}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0017504', 'cui_str': 'Fetal gestational age'}, {'cui': 'C0450104', 'cui_str': 'Orogastric'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C4517489', 'cui_str': '1.08'}, {'cui': 'C0694637', 'cui_str': 'Nasogastric route'}, {'cui': 'C0005612', 'cui_str': 'Birth weight'}, {'cui': 'C4048294', 'cui_str': 'Preterm Infants'}]","[{'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0175730', 'cui_str': 'Tube'}, {'cui': 'C0450104', 'cui_str': 'Orogastric'}, {'cui': 'C0694637', 'cui_str': 'Nasogastric route'}, {'cui': 'C0014327', 'cui_str': 'Enteral nutrition'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0004056', 'cui_str': 'Aspiration, Psychology'}, {'cui': 'C0041281', 'cui_str': 'Tube feeding of patient'}, {'cui': 'C0012725', 'cui_str': 'Displacement - mental defense mechanism'}, {'cui': 'C0086225', 'cui_str': 'Enteral feeding'}, {'cui': 'C0003578', 'cui_str': 'Apnea'}, {'cui': 'C0014356', 'cui_str': 'Enterocolitis'}, {'cui': 'C0428977', 'cui_str': 'Bradycardia'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0746961', 'cui_str': 'Oxygen saturation below reference range'}, {'cui': 'C3665864', 'cui_str': 'Gastric residual assessment'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C2945625', 'cui_str': 'Feeding tube'}, {'cui': 'C0032290', 'cui_str': 'Aspiration pneumonia'}, {'cui': 'C3714636', 'cui_str': 'Pneumonitis'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",98.0,0.0690969,"There was no difference in the incidence rates of apnea, necrotizing enterocolitis, bradycardia, oxygen desaturation, and gastric residual in both groups. ","[{'ForeName': 'Ahmed Tawfik', 'Initials': 'AT', 'LastName': 'Badran', 'Affiliation': 'Department of Pediatrics, SUNY Downstate Health Sciences University, Brooklyn, New York.'}, {'ForeName': 'Menna', 'Initials': 'M', 'LastName': 'Hashish', 'Affiliation': ""Neonatal Intensive Care Unit, Mansoura University Children's Hospital, Mansoura, Egypt.""}, {'ForeName': 'Alaa', 'Initials': 'A', 'LastName': 'Ali', 'Affiliation': 'Department of Pediatrics, National Research Center, Cairo, Egypt.'}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Shokeir', 'Affiliation': ""Department of Pediatrics, Mansoura University Children's Hospital, Mansoura, Egypt.""}, {'ForeName': 'Abd', 'Initials': 'A', 'LastName': 'Shabaan', 'Affiliation': ""Neonatal Intensive Care Unit, Mansoura University Children's Hospital, Mansoura, Egypt.""}]",American journal of perinatology,['10.1055/s-0040-1713865'] 2863,32620024,Effects of Umbilical Cord Milking on Anemia in Preterm Infants: A Multicenter Randomized Controlled Trial.,"OBJECTIVE This study aimed to investigate whether umbilical cord milking (UCM) prevents and controls anemia in preterm infants, as compared with immediate cord clamping (ICC). STUDY DESIGN Pregnant women delivering at <34 weeks' gestation in four hospitals were randomly assigned to undergo UCM or ICC from July 2017 to June 2019. Hematological parameters and iron status were collected and analyzed as primary outcomes at 24 hours, 1 week, 2 weeks, and 6 months after delivery. RESULTS Neonates receiving UCM had significant higher levels of hemoglobin (Hb), hematocrit, and serum iron ( p  < 0.05). Lower prevalence of anemia and lower need for transfusions were noted in UCM group. Although UCM was associated with prolonged duration of phototherapy, the maximum levels of bilirubin were similar between two groups ( p  > 0.05). CONCLUSION UCM is an effective intervention to help preterm infants experience less anemia with the potential to increase blood volume, as seen by higher Hb levels and more enhanced iron stores.",2020,Lower prevalence of anemia and lower need for transfusions were noted in UCM group.,"[""Pregnant women delivering at <34 weeks' gestation in four hospitals"", 'Preterm Infants', 'preterm infants']","['Umbilical Cord Milking', 'umbilical cord milking (UCM', 'UCM', 'UCM or ICC']","['maximum levels of bilirubin', 'levels of hemoglobin (Hb), hematocrit, and serum iron', 'Hematological parameters and iron status']","[{'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0021294', 'cui_str': 'Premature infant'}]","[{'cui': 'C0041633', 'cui_str': 'Umbilical cord structure'}, {'cui': 'C0205253', 'cui_str': 'Immediate'}, {'cui': 'C3489532', 'cui_str': 'Cone-Rod Dystrophy 2'}, {'cui': 'C0521213', 'cui_str': 'Clamping'}]","[{'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0005437', 'cui_str': 'Bilirubin'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0018935', 'cui_str': 'Hematocrit determination'}, {'cui': 'C1318312', 'cui_str': 'Serum iron measurement'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0082568', 'cui_str': 'ferryl iron'}, {'cui': 'C0449438', 'cui_str': 'Status'}]",,0.200306,Lower prevalence of anemia and lower need for transfusions were noted in UCM group.,"[{'ForeName': 'Yu-Jie', 'Initials': 'YJ', 'LastName': 'Xie', 'Affiliation': ""Department of Neonatology, Xinhua Hospital Affiliated to Shanghai Jiaotong University Medical College, Shanghai, People's Republic of China.""}, {'ForeName': 'Jia-Li', 'Initials': 'JL', 'LastName': 'Xiao', 'Affiliation': ""Department of Neonatology, Jiaxing Maternity & Child health Care Hospital, Jiaxing, People's Republic of China.""}, {'ForeName': 'Juan-Juan', 'Initials': 'JJ', 'LastName': 'Zhu', 'Affiliation': ""Department of Neonatology, Xinhua Hospital Affiliated to Shanghai Jiaotong University Medical College, Shanghai, People's Republic of China.""}, {'ForeName': 'Yi-Wen', 'Initials': 'YW', 'LastName': 'Wang', 'Affiliation': ""Department of Neonatology, Xinhua Hospital Affiliated to Shanghai Jiaotong University Medical College, Shanghai, People's Republic of China.""}, {'ForeName': 'Bei', 'Initials': 'B', 'LastName': 'Wang', 'Affiliation': ""Department of Obstetrics, Xinhua Hospital Affiliated to Shanghai Jiaotong University Medical College, Shanghai, People's Republic of China.""}, {'ForeName': 'Li-Juan', 'Initials': 'LJ', 'LastName': 'Xie', 'Affiliation': ""Department of Neonatology, Xinhua Hospital Affiliated to Shanghai Jiaotong University Medical College, Shanghai, People's Republic of China.""}]",American journal of perinatology,['10.1055/s-0040-1713350'] 2864,32620104,"A double-blind, randomized pilot study for comparison of Melissa officinalis L. and Lavandula angustifolia Mill. with Fluoxetine for the treatment of depression.","BACKGROUND Depression has rapidly progressed worldwide, and the need for an efficient treatment with low side effect has risen. Melissa officinalis L and Lavandula angustifolia Mill have been traditionally used in Asia for the treatment of depression. Many textbooks of traditional Persian medicine refer to these herbs for the treatment of depression while there are no adequate clinical trials to support this claim. The present study aimed to evaluate the efficacy of M. officinalis and L. angustifolia compared to fluoxetine for the treatment of mild to moderate depression in an 8-week randomized, double-blind clinical trial. METHODS Forty-five adult outpatients who met the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5) for major depression, were randomly assigned to 3 groups to daily receive either M. officinalis (2 g) or L. angustifolia (2 g) or fluoxetine (20 mg) and were assessed in weeks 0, 2, 4 and 8 by the Hamilton Rating Scale for Depression (HAM-D) including 17 items. RESULTS Our study showed that M. officinalis and L. angustifolia effect similar to fluoxetine in mild to moderate depression. (F = 0.131, df = 2,42, p = 0.877). CONCLUSION Due to some restrictions in this study including absence of placebo group, large-scale trials are needed to investigate the anti-depressant effect of these two herbs with more details. TRIAL REGISTRATION IRCT2014061718126N1 . Registration date: 2015-06-04-""Retrospectively registered"".",2020,"(F = 0.131, df = 2,42, p = 0.877). ","['Forty-five adult outpatients who met the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5) for major depression', 'mild to moderate depression']","['fluoxetine', 'Melissa officinalis L and Lavandula angustifolia', 'M. officinalis (2\u2009g) or L. angustifolia (2\u2009g) or fluoxetine', 'Melissa officinalis L. and Lavandula angustifolia Mill', 'Fluoxetine', 'placebo']",[],"[{'cui': 'C4319567', 'cui_str': '45'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C1136324', 'cui_str': 'Diagnostic and Statistical Manual of Mental Disorders'}, {'cui': 'C0205439', 'cui_str': 'Fifth'}, {'cui': 'C0441792', 'cui_str': 'Editions'}, {'cui': 'C1137105', 'cui_str': 'DSM-V'}, {'cui': 'C0041696', 'cui_str': 'Depression, Unipolar'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]","[{'cui': 'C0016365', 'cui_str': 'Fluoxetine'}, {'cui': 'C1008143', 'cui_str': 'Lemon Balm'}, {'cui': 'C1623196', 'cui_str': 'Lavandula angustifolia'}, {'cui': 'C0599997', 'cui_str': 'Mill'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]",[],45.0,0.0615834,"(F = 0.131, df = 2,42, p = 0.877). ","[{'ForeName': 'Mostafa', 'Initials': 'M', 'LastName': 'Araj-Khodaei', 'Affiliation': 'Department of Traditional Medicine, School of Medicine, Shahed University, 1471, North Kargar, Engelab Square, Tehran, Iran.'}, {'ForeName': 'Ahmad Ali', 'Initials': 'AA', 'LastName': 'Noorbala', 'Affiliation': 'Psychosomatic Medicine Research center, Psychosomatic Ward, Imam Khomeini Hospital, Tehran University of Medical Sciences, End of Keshavarz Blv, Tehran, Iran.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Yarani', 'Affiliation': 'Department of Pediatrics E, Copenhagen Diabetes Research Center (CPH-DIRECT), Herlev University Hospital, Herlev, 2730, Copenhagen, Denmark.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Emadi', 'Affiliation': 'Department of Traditional Medicine, School of Medicine, Shahed University, 1471, North Kargar, Engelab Square, Tehran, Iran.'}, {'ForeName': 'Elham', 'Initials': 'E', 'LastName': 'Emaratkar', 'Affiliation': 'Department of Traditional Medicine, School of Medicine, Shahed University, 1471, North Kargar, Engelab Square, Tehran, Iran.'}, {'ForeName': 'Soghrat', 'Initials': 'S', 'LastName': 'Faghihzadeh', 'Affiliation': 'Department of Biostatistic and Epidemiology, School of Medicine, Zanjan University of Medical Sciences, Mahdavi St., Karmandan Town, Zanjan, Iran.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Parsian', 'Affiliation': 'Emergency Medicine Research Team, Daneshgah St. Imam Reza Hospital, Tabriz University of Medical Sciences, Tabriz, Iran.'}, {'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Alijaniha', 'Affiliation': 'Traditional Medicine Clinical Trial Research Center, Shahed University, 1471, North Kargar, Engelab Square, Tehran, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Kamalinejad', 'Affiliation': 'School of Pharmacy, Shahid Beheshti University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mohsen', 'Initials': 'M', 'LastName': 'Naseri', 'Affiliation': 'Department of Traditional Medicine, School of Medicine, Shahed University, 1471, North Kargar, Engelab Square, Tehran, Iran. naseri@shahed.ac.ir.'}]",BMC complementary medicine and therapies,['10.1186/s12906-020-03003-5'] 2865,32620116,Impact of the CareWell integrated care model for older patients with multimorbidity: a quasi-experimental controlled study in the Basque Country.,"BACKGROUND Older patients with multimorbidity have complex health and social care needs, associated with elevated use of health care resources. The aim of this study is to evaluate the impact of CareWell integrated care model for older patients with multimorbidity in the Basque Country. METHODS The CareWell program for older patients with multimorbidity, based on the coordination between health providers, home-based care and patient empowerment, supported by information and communication technology tools. The program was deployed in four healthcare areas in the Basque Country. The control group was formed by two organizations in which the program had not been deployed and regular care procedures were applied. Participants, older patients (aged ≥65) with two or more chronic conditions (at least one being chronic obstructive pulmonary disease, chronic heart failure, or diabetes mellitus), categorized as complex according to a risk stratification algorithm, were followed up to 12 months. The impact of the program on the use of health resources, clinical effectiveness, and satisfaction was evaluated using a mixed-method approach. Semi-structured interviews were performed to assess satisfaction with the newly deployed model and mixed regression models to measure the effect of the intervention throughout the follow-up period. RESULTS Two hundred patients were recruited (101 intervention and 99 control), mostly males (63%) with a mean age of 79 years and age-adjusted Charlson Comorbidity Index of 9.7 on average. Relevant differences between the groups were observed for all dimensions. In the intervention group, the number of hospitalizations and visits to emergency centers was reduced, and the number of primary care contacts increased. Clinical changes were also observed, such as a decrease in the body mass index and blood glucose levels. The satisfaction level was high for all stakeholders. CONCLUSION The implementation of CareWell integrated care model changed the profile of health resource utilization, strengthening the key role of primary care and reducing the number of emergency visits and hospitalizations. The satisfaction with this model of care was high. TRIAL REGISTRATION ClinicalTrials.gov, NCT03042039 . Registered 3 February 2017 - Retrospectively registered.",2020,"In the intervention group, the number of hospitalizations and visits to emergency centers was reduced, and the number of primary care contacts increased.","['Two hundred patients were recruited (101 intervention and 99 control), mostly males (63%) with a mean age of 79\u2009years and age-adjusted Charlson Comorbidity Index of 9.7 on average', 'Older patients with multimorbidity', 'Registered 3 February 2017', 'older patients with multimorbidity in the Basque Country', 'Participants, older patients (aged ≥65) with two or more chronic conditions (at least one being chronic obstructive pulmonary disease, chronic heart failure, or diabetes mellitus', 'older patients with multimorbidity']",['CareWell integrated care model'],"['body mass index and blood glucose levels', 'satisfaction level', 'number of hospitalizations and visits to emergency centers']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C4546361', 'cui_str': 'Charlson Comorbidity Index'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C1535889', 'cui_str': 'Multimorbidity'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0337796', 'cui_str': 'Basques'}, {'cui': 'C0454664', 'cui_str': 'Country'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0024117', 'cui_str': 'Chronic obstructive lung disease'}, {'cui': 'C0018802', 'cui_str': 'Congestive heart failure'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}]","[{'cui': 'C0026339', 'cui_str': 'Biological Models'}]","[{'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0392201', 'cui_str': 'Glucose measurement, blood'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0175673', 'cui_str': 'Emergency'}, {'cui': 'C0205099', 'cui_str': 'Central'}]",200.0,0.0243765,"In the intervention group, the number of hospitalizations and visits to emergency centers was reduced, and the number of primary care contacts increased.","[{'ForeName': 'Maider', 'Initials': 'M', 'LastName': 'Mateo-Abad', 'Affiliation': 'Kronikgune Institute for Health Services Research, Barakaldo, Basque Country, Spain. maider.mateoabad@osakidetza.eus.'}, {'ForeName': 'Nerea', 'Initials': 'N', 'LastName': 'González', 'Affiliation': 'Kronikgune Institute for Health Services Research, Barakaldo, Basque Country, Spain.'}, {'ForeName': 'Ane', 'Initials': 'A', 'LastName': 'Fullaondo', 'Affiliation': 'Kronikgune Institute for Health Services Research, Barakaldo, Basque Country, Spain.'}, {'ForeName': 'Marisa', 'Initials': 'M', 'LastName': 'Merino', 'Affiliation': 'Osakidetza Basque Health Service, Tolosaldea Integrated Health Care Organization, Tolosa, Basque Country, Spain.'}, {'ForeName': 'Lierni', 'Initials': 'L', 'LastName': 'Azkargorta', 'Affiliation': 'Osakidetza Basque Health Service, Tolosaldea Integrated Health Care Organization, Tolosa, Basque Country, Spain.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Giné', 'Affiliation': 'Kronikgune Institute for Health Services Research, Barakaldo, Basque Country, Spain.'}, {'ForeName': 'Dolores', 'Initials': 'D', 'LastName': 'Verdoy', 'Affiliation': 'Kronikgune Institute for Health Services Research, Barakaldo, Basque Country, Spain.'}, {'ForeName': 'Itziar', 'Initials': 'I', 'LastName': 'Vergara', 'Affiliation': 'Kronikgune Institute for Health Services Research, Barakaldo, Basque Country, Spain.'}, {'ForeName': 'Esteban', 'Initials': 'E', 'LastName': 'de Manuel Keenoy', 'Affiliation': 'Kronikgune Institute for Health Services Research, Barakaldo, Basque Country, Spain.'}]",BMC health services research,['10.1186/s12913-020-05473-2'] 2866,32615462,The effect of baclofen on objective and subjective sleep measures in a model of transient insomnia.,"STUDY OBJECTIVES Insomnia is a common medical complaint. Current pharmacologic treatments have modest efficacy and numerous side effects. Baclofen is a gamma-aminobutyric acid (GABA)b receptor agonist used to treat spasticity in various medical conditions. Several studies noted that baclofen, when used to treat sleep related disorders, resulted in improvement in sleep parameters. Measures of insomnia, however, were not assessed in those studies. To date, baclofen has not been assessed for efficacy in the treatment of insomnia. METHODS We randomized 20 healthy subjects to baclofen or placebo in a cross over design. All subjects underwent two polysomnograms (PSG) assessing sleep parameters. Baclofen or placebo was given 90 min prior to lights out in random order for each subject. Lights out occurred two hours earlier than the subject's median habitual bedtime. RESULTS Baclofen resulted in significantly less objective wake after sleep onset and stage 1 sleep, and significantly increased total sleep time (TST), sleep efficiency, and stage 3/4 sleep. There was no effect on sleep onset latency (SOL). Self-report variables indicated significantly less subjective awakenings from sleep and increased subjective sleep quality. There was no effect on subjective TST or subjective SOL. CONCLUSIONS This study showed that baclofen was superior to placebo with regard to several objective and subjective measures used to assess sleep quality. These data support the notion that baclofen shows promise as an effective hypnotic drug.",2020,This study showed that baclofen was superior to placebo with regard to several objective and subjective measures used to assess sleep quality.,['20 healthy subjects to'],"['baclofen', 'baclofen or placebo', 'Baclofen or placebo', 'placebo']","['subjective awakenings from sleep and increased subjective sleep quality', 'sleep parameters', 'sleep onset latency (SOL', 'subjective TST or subjective SOL', 'total sleep time (TST), sleep efficiency, and stage 3/4 sleep', 'objective wake after sleep onset and stage 1 sleep', 'sleep quality', 'objective and subjective sleep measures']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0004609', 'cui_str': 'Baclofen'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C1720052', 'cui_str': 'Awakening'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C4505222', 'cui_str': 'Sleep Onset Latency'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0442757', 'cui_str': '3/4'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0442696', 'cui_str': 'Waking'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",20.0,0.028149,This study showed that baclofen was superior to placebo with regard to several objective and subjective measures used to assess sleep quality.,"[{'ForeName': 'Samih', 'Initials': 'S', 'LastName': 'Raad', 'Affiliation': 'University of Oklahoma Health Sciences Center, Section of Pulmonary Critical Care & Sleep Medicine, Oklahoma City, OK, USA. Electronic address: Samih-Raad@ouhsc.edu.'}, {'ForeName': 'Meredith', 'Initials': 'M', 'LastName': 'Wilkerson', 'Affiliation': 'Lynn Health Science Institute, Oklahoma City, OK, USA. Electronic address: Meredith-Wilkerson@ouhsc.edu.'}, {'ForeName': 'Kellie R', 'Initials': 'KR', 'LastName': 'Jones', 'Affiliation': 'University of Oklahoma Health Sciences Center, Section of Pulmonary Critical Care & Sleep Medicine, Oklahoma City, OK, USA. Electronic address: Kellie-Jones@ouhsc.edu.'}, {'ForeName': 'William C', 'Initials': 'WC', 'LastName': 'Orr', 'Affiliation': 'University of Oklahoma Health Sciences Center, Lynn Health Science Institute, Oklahoma City, OK, USA. Electronic address: worr@lhsi.net.'}]",Sleep medicine,['10.1016/j.sleep.2020.03.028'] 2867,32615473,Acceptance and commitment therapy combined with vestibular rehabilitation for persistent postural-perceptual dizziness: A pilot study.,"PURPOSE This study investigated the feasibility of acceptance and commitment therapy for persistent postural-perceptual dizziness and preliminarily verified the long-term effectiveness of the therapy. MATERIALS AND METHODS This study implemented the within-group pre-post comparison design. We enrolled 27 adult patients who met the criteria of persistent postural-perceptual dizziness. They underwent a treatment program including acceptance and commitment therapy combined with vestibular rehabilitation once a week for a total of six sessions. The primary outcome was changes in the Dizziness Handicap Inventory score 6 months posttreatment. RESULTS All 27 patients completed the acceptance and commitment therapy + vestibular rehabilitation program, and 25 patients (92.6%) could be followed for 6 months posttreatment. For 27 participants, the scores from pretreatment to 6 months posttreatment significantly declined (P < .001), and the Dizziness Handicap Inventory effect size was 1.11 (95% confidence interval = 0.80-1.42). At 6 months posttreatment, 11 patients (40.7%) achieved remission (the score ≤ 14), 16 (59.3%) achieved treatment response (reduction in the score ≥ 18), and 20 (74.1%) achieved remission and/or treatment response. CONCLUSIONS Acceptance and commitment therapy is feasible for persistent postural-perceptual dizziness and might have long-term effectiveness. However, a randomized controlled trial is warranted.",2020,"For 27 participants, the scores from pretreatment to 6 months posttreatment significantly declined (P < .001), and the Dizziness Handicap Inventory effect size was 1.11 (95% confidence interval = 0.80-1.42).","['persistent postural-perceptual dizziness', '27 adult patients who met the criteria of persistent postural-perceptual dizziness']","['Acceptance and commitment therapy combined with vestibular rehabilitation', 'acceptance and commitment therapy', 'acceptance and commitment therapy combined with vestibular rehabilitation']","['Dizziness Handicap Inventory effect size', 'remission', 'Dizziness Handicap Inventory score 6\xa0months posttreatment', 'remission and/or treatment response']","[{'cui': 'C0522360', 'cui_str': 'Persistent postural perceptual dizziness'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C3658321', 'cui_str': 'Acceptance and commitment therapy'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0200324', 'cui_str': 'Vestibular rehabilitation'}]","[{'cui': 'C0012833', 'cui_str': 'Dizziness'}, {'cui': 'C0231172', 'cui_str': 'Handicap'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0544452', 'cui_str': 'Remission phase'}, {'cui': 'C4304791', 'cui_str': 'Dizziness Handicap Inventory score'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",27.0,0.176719,"For 27 participants, the scores from pretreatment to 6 months posttreatment significantly declined (P < .001), and the Dizziness Handicap Inventory effect size was 1.11 (95% confidence interval = 0.80-1.42).","[{'ForeName': 'Junya', 'Initials': 'J', 'LastName': 'Kuwabara', 'Affiliation': 'Department of Psychiatry and Cognitive-Behavioral Medicine, Nagoya City University Graduate School of Medical Sciences, Mizuho-cho, Mizuho-ku, Nagoya 467-8601, Japan. Electronic address: jurry7777@hotmail.co.jp.'}, {'ForeName': 'Masaki', 'Initials': 'M', 'LastName': 'Kondo', 'Affiliation': 'Department of Psychiatry and Cognitive-Behavioral Medicine, Nagoya City University Graduate School of Medical Sciences, Mizuho-cho, Mizuho-ku, Nagoya 467-8601, Japan. Electronic address: kondo-masaki@umin.ac.jp.'}, {'ForeName': 'Kayoko', 'Initials': 'K', 'LastName': 'Kabaya', 'Affiliation': 'Department of Otolaryngology, Nagoya City University Graduate School of Medical Sciences, Mizuho-cho, Mizuho-ku, Nagoya 467-8601, Japan. Electronic address: kabaya@med.nagoya-cu.ac.jp.'}, {'ForeName': 'Wakako', 'Initials': 'W', 'LastName': 'Watanabe', 'Affiliation': 'Department of Psychiatry and Cognitive-Behavioral Medicine, Nagoya City University Graduate School of Medical Sciences, Mizuho-cho, Mizuho-ku, Nagoya 467-8601, Japan; Kikuchi Mental Clinic, Ushikubo-cho, Toyokawa 442-0826, Japan. Electronic address: wakakoigarashi@gmail.com.'}, {'ForeName': 'Nao', 'Initials': 'N', 'LastName': 'Shiraishi', 'Affiliation': 'Department of Psychiatry and Cognitive-Behavioral Medicine, Nagoya City University Graduate School of Medical Sciences, Mizuho-cho, Mizuho-ku, Nagoya 467-8601, Japan. Electronic address: fecitanno@gmail.com.'}, {'ForeName': 'Mie', 'Initials': 'M', 'LastName': 'Sakai', 'Affiliation': 'Department of Psychiatry and Cognitive-Behavioral Medicine, Nagoya City University Graduate School of Medical Sciences, Mizuho-cho, Mizuho-ku, Nagoya 467-8601, Japan. Electronic address: mie.sakai.38@gmail.com.'}, {'ForeName': 'Yuko', 'Initials': 'Y', 'LastName': 'Toshishige', 'Affiliation': 'Department of Psychiatry and Cognitive-Behavioral Medicine, Nagoya City University Graduate School of Medical Sciences, Mizuho-cho, Mizuho-ku, Nagoya 467-8601, Japan. Electronic address: yuu0323uchi@yahoo.co.jp.'}, {'ForeName': 'Keiko', 'Initials': 'K', 'LastName': 'Ino', 'Affiliation': 'Department of Psychiatry and Cognitive-Behavioral Medicine, Nagoya City University Graduate School of Medical Sciences, Mizuho-cho, Mizuho-ku, Nagoya 467-8601, Japan. Electronic address: miniture_flute@hotmail.com.'}, {'ForeName': 'Meiho', 'Initials': 'M', 'LastName': 'Nakayama', 'Affiliation': 'Department of Otolaryngology, Nagoya City University Graduate School of Medical Sciences, Mizuho-cho, Mizuho-ku, Nagoya 467-8601, Japan; Good Sleep Center, Nagoya City University Hospital, Mizuho-cho, Mizuho-ku, Nagoya 467-8601, Japan. Electronic address: nakayama@med.nagoya-cu.ac.jp.'}, {'ForeName': 'Shinichi', 'Initials': 'S', 'LastName': 'Iwasaki', 'Affiliation': 'Department of Otolaryngology, Nagoya City University Graduate School of Medical Sciences, Mizuho-cho, Mizuho-ku, Nagoya 467-8601, Japan. Electronic address: iwashin-tky@umin.ac.jp.'}, {'ForeName': 'Tatsuo', 'Initials': 'T', 'LastName': 'Akechi', 'Affiliation': 'Department of Psychiatry and Cognitive-Behavioral Medicine, Nagoya City University Graduate School of Medical Sciences, Mizuho-cho, Mizuho-ku, Nagoya 467-8601, Japan. Electronic address: takechi@med.nagoya-cu.ac.jp.'}]",American journal of otolaryngology,['10.1016/j.amjoto.2020.102609'] 2868,32615487,A quasi-cluster randomized controlled trial of a classroom-based mental health literacy educational intervention to promote knowledge and help-seeking/helping behavior in adolescents.,"INTRODUCTION School-based education is a potentially effective approach for improving mental health literacy (MHL) in adolescents. This study evaluated the effects of the ""Short MHL Program (SMHLP)"", a brief (50 min), school teacher-led program, on MHL in adolescents in a quasi-cluster randomized controlled trial. METHODS A total of 975 high school first graders (age 15-16) in Japan were allocated to classes such that gender and academic achievement ratios were almost equivalent at the time of admission to the high school. They were assigned at the class level to the SMHLP (n = 364 from 10 classes) or a control group (n = 611 from 17 classes). The program consisted of a 50-minute session and was delivered by a school teacher. The students completed a self-report questionnaire at 3 time points: pre-, (immediately) post- and 2-month follow-up. Outcomes included ""Knowledge about mental health/illnesses"", ""Recognition of the necessity to seek help"", ""Intention to seek help"", and ""Intention of helping peers"". Mixed effects modeling was employed for analyses. RESULTS Scores of all outcomes were significantly improved in the intervention group compared to the control group post-intervention (p < .001). These improvements were maintained at 2-months follow-up for all outcomes (p < .001-.05). Questionnaire scores did not differ between groups at baseline. CONCLUSIONS The effect of the SMHLP was confirmed in grade 10 students. Brief, yet effective programs can be a viable option to promote understanding of mental health problems and have the potential to be incorporated into regular school curriculum. "".",2020,These improvements were maintained at 2-months follow-up for all outcomes (p < .001-.05).,"['A total of 975 high school first graders (age 15-16) in Japan', 'grade 10 students', 'adolescents']","['SMHLP', 'classroom-based mental health literacy educational intervention', 'Short MHL Program (SMHLP)"", a brief (50 min), school teacher-led program, on MHL']","['Knowledge about mental health/illnesses"", ""Recognition of the necessity to seek help"", ""Intention to seek help"", and ""Intention of helping peers', 'Questionnaire scores']","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C4517911', 'cui_str': '975'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0022341', 'cui_str': 'Japan'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0024851', 'cui_str': 'Marshall Islands'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0023864', 'cui_str': 'Literacy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0023865', 'cui_str': 'Literacy Programs'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0036374', 'cui_str': 'School teacher'}, {'cui': 'C0023175', 'cui_str': 'Lead'}]","[{'cui': 'C0376554', 'cui_str': 'Knowledge'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0221423', 'cui_str': 'Illness'}, {'cui': 'C0524637', 'cui_str': 'Recognition'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",975.0,0.047281,These improvements were maintained at 2-months follow-up for all outcomes (p < .001-.05).,"[{'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Yamaguchi', 'Affiliation': 'Department of Physical and Health Education, Graduate School of Education, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-0033, Japan. Electronic address: yama-s@p.u-tokyo.ac.jp.'}, {'ForeName': 'Yasutaka', 'Initials': 'Y', 'LastName': 'Ojio', 'Affiliation': 'Department of Community Mental Health and Law, National Institute of Mental Health, National Center of Neurology and Psychiatry, 4-1-1 Ogawa-Higashi, Kodaira, Tokyo, 187-8553, Japan. Electronic address: ojio@ncnp.go.jp.'}, {'ForeName': 'Jerome Clifford', 'Initials': 'JC', 'LastName': 'Foo', 'Affiliation': 'Central Institute of Mental Health, Department of Genetic Epidemiology in Psychiatry, Medical Faculty Mannheim, University of Heidelberg, J5 68159, Mannheim, Germany. Electronic address: jeromefoo@gmail.com.'}, {'ForeName': 'Emiko', 'Initials': 'E', 'LastName': 'Michigami', 'Affiliation': 'Saitama Prefectural Soka Higashi High School, 1110-1 Kakinoki-cho, Soka, Saitama, 340-0001, Japan. Electronic address: michigami@msj.biglobe.ne.jp.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Usami', 'Affiliation': 'Center for Research and Development on Transition from Secondary to Higher Education, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-0033, Japan. Electronic address: usami_s@p.u-tokyo.ac.jp.'}, {'ForeName': 'Taruto', 'Initials': 'T', 'LastName': 'Fuyama', 'Affiliation': 'Graduate School of Film and New Media, Tokyo University of the Arts, 4-23, Kaigan-dori, Naka-ku, Yokohama, Kanagawa, 231-0002, Japan. Electronic address: fuyan@taruto.com.'}, {'ForeName': 'Kumiko', 'Initials': 'K', 'LastName': 'Onuma', 'Affiliation': 'Department of Health and Nutrition, Laboratory of Practical Yogo Science, Kagawa Education Institute of Nutrition, 3-9-21 Chiyoda, Sakado, Saitama, 350-0288, Japan. Electronic address: kokumichan@gmail.com.'}, {'ForeName': 'Norihito', 'Initials': 'N', 'LastName': 'Oshima', 'Affiliation': 'Office for Mental Health Support, Division for Counseling and Support, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-0033, Japan. Electronic address: rxg01737@qg8.so-net.ne.jp.'}, {'ForeName': 'Shuntaro', 'Initials': 'S', 'LastName': 'Ando', 'Affiliation': 'Department of Psychiatry and Behavioral Science, Tokyo Metropolitan Institute of Medical Science, 2-1-6, Kamikitazawa, Setagaya-ku, Tokyo, 156-8506, Japan. Electronic address: sandou-tky@umin.ac.jp.'}, {'ForeName': 'Fumiharu', 'Initials': 'F', 'LastName': 'Togo', 'Affiliation': 'Department of Physical and Health Education, Graduate School of Education, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-0033, Japan. Electronic address: tougou@p.u-tokyo.ac.jp.'}, {'ForeName': 'Tsukasa', 'Initials': 'T', 'LastName': 'Sasaki', 'Affiliation': 'Department of Physical and Health Education, Graduate School of Education, The University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo, 113-0033, Japan. Electronic address: psytokyo577@gmail.com.'}]",Journal of adolescence,['10.1016/j.adolescence.2020.05.002'] 2869,32615488,Effects of the juçara fruit supplementation on metabolic parameters in individuals with obesity: a double-blind randomized controlled trial.,"Adipose tissue inflammation has been proposed as a central mechanism connecting obesity with its metabolic and vascular complications due to the imbalance in the expression of several hormones and adipokines. Berries rich in polyphenols and unsaturated fatty acids have been able to prevent both obesity and adipose tissue inflammation, improving metabolic functions in human subjects and animal models of obesity. Juçara has been considered a super fruit owing to its nutritional composition and relevant biological activities with an interesting response in animals. Thus, we aimed to verify the potential antiobesogenic effect of juçara supplementation in humans. We conducted a double-blind, placebo-controlled, randomized trial with 35 adults with obesity of both sexes. They were assessed for resting metabolic rate, anthropometry and body composition, blood pressure, metabolic parameters and adipokines. Subsequently, they were randomized into two groups to use or not (placebo) 5 g lyophilized juçara for 6 weeks. Supplementation with juçara was significantly effective in reducing body fat, increasing high-density lipoprotein cholesterol and doubling serum adiponectin. Besides, juçara supplementation, high-density lipoprotein cholesterol and neck circumference were predictors to explain the enhancement in adiponectin. Juçara supplementation was determinant to improve adiponectin levels, and it may be considered a novel strategy for the treatment of obesity-related metabolic diseases.",2020,"Supplementation with juçara was significantly effective in reducing body fat, increasing high-density lipoprotein cholesterol and doubling serum adiponectin.","['35 adults with obesity of both sexes', 'individuals with obesity', 'humans']","['juçara fruit supplementation', 'juçara supplementation', 'not (placebo', 'placebo']","['body fat, increasing high-density lipoprotein cholesterol and doubling serum adiponectin', 'resting metabolic rate, anthropometry and body composition, blood pressure, metabolic parameters and adipokines', 'juçara supplementation, high-density lipoprotein cholesterol and neck circumference', 'metabolic parameters', 'adiponectin levels']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}]","[{'cui': 'C0016767', 'cui_str': 'Fruit'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0001527', 'cui_str': 'Adipose tissue'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0023822', 'cui_str': 'HDL cholesterol'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C4082350', 'cui_str': 'Resting Metabolic Rate'}, {'cui': 'C0003188', 'cui_str': 'Anthropometry'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C1955907', 'cui_str': 'Adipokine'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C1630403', 'cui_str': 'Neck circumference'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",35.0,0.113597,"Supplementation with juçara was significantly effective in reducing body fat, increasing high-density lipoprotein cholesterol and doubling serum adiponectin.","[{'ForeName': 'Giovana', 'Initials': 'G', 'LastName': 'Jamar', 'Affiliation': 'Programa de Pós-Graduação Interdisciplinar em Ciências da Saúde, Universidade Federal de São Paulo, Santos, SP, Brazil; Laboratório de Nutrição e Fisiologia Endócrina (LaNFE), Universidade Federal de São Paulo, Santos, SP, Brazil.'}, {'ForeName': 'Aline Boveto', 'Initials': 'AB', 'LastName': 'Santamarina', 'Affiliation': 'Programa de Pós-Graduação Interdisciplinar em Ciências da Saúde, Universidade Federal de São Paulo, Santos, SP, Brazil; Laboratório de Nutrição e Fisiologia Endócrina (LaNFE), Universidade Federal de São Paulo, Santos, SP, Brazil.'}, {'ForeName': 'Ana Carolina', 'Initials': 'AC', 'LastName': 'Flygare', 'Affiliation': 'Programa de Pós-Graduação Interdisciplinar em Ciências da Saúde, Universidade Federal de São Paulo, Santos, SP, Brazil.'}, {'ForeName': 'Antônio', 'Initials': 'A', 'LastName': 'Gagliardi', 'Affiliation': 'Departamento de Medicina Cardiovascular, Angiocorpore Instituto de Medicina Cardiovascular, Santos, SP, Brazil.'}, {'ForeName': 'Veridiana Vera', 'Initials': 'VV', 'LastName': 'de Rosso', 'Affiliation': 'Departamento de Biociências, Instituto de Saúde e Sociedade, Universidade Federal de São Paulo, Santos, SP, Brazil.'}, {'ForeName': 'Victor Zuniga', 'Initials': 'VZ', 'LastName': 'Dourado', 'Affiliation': 'Departamento de Ciências do Movimento Humano, Universidade Federal de São Paulo, Santos, SP, Brazil.'}, {'ForeName': 'Luciana Pellegrini', 'Initials': 'LP', 'LastName': 'Pisani', 'Affiliation': 'Laboratório de Nutrição e Fisiologia Endócrina (LaNFE), Universidade Federal de São Paulo, Santos, SP, Brazil; Departamento de Biociências, Instituto de Saúde e Sociedade, Universidade Federal de São Paulo, Santos, SP, Brazil. Electronic address: lucianapisani@gmail.com.'}]",The Journal of nutritional biochemistry,['10.1016/j.jnutbio.2020.108430'] 2870,32615658,"Effect of Dextrose Prolotherapy, Platelet Rich Plasma and Autologous Conditioned Serum on Knee Osteoarthritis: A Randomized Clinical Trial.","Knee osteoarthritis (OA) is one of the common degenerative articular disorders that are related to decreased quality of life. Currently, novel biologic therapeutic approaches are introduced in the literature for OA management. In this study, the clinical efficiency of Dextrose prolotherapy, platelet-rich plasma (PRP) and autologous conditioned serum (ACS) injection on the level of pain and function in Knee OA were compared. A randomized clinical trial was directed on 92 knee OA patients. Patients were randomly divided into three groups: 30 were received dextrose prolotherapy once in a week for three weeks, 30 received autologous PRP for two times with seven days interval, and in the remaining 32 patients 2ml of ACS were injected two times every seven days. Study participants were measured through the Western Ontario and McMaster Universities (WOMAC) score, the visual analogue scale (VAS), at baseline, 1 and 6 months post-intervention. Both ACS and PRP treated patients showed improvement in pain intensity and knee function during 1 and 6 months pursue; however, this progress was more significant in the ACS group. Dextrose prolotherapy showed no substantial changes in pain and function of the affected knee in treated patients. Treatment of Knee OA with ACS and PRP injections are associated with pain reduction and knee function improvement. Not only, ACS therapy is more effective than that of PRP, but also due to its less variability in processing and less reported side effects, it could be considered as a safe and effective non-surgical alternative for OA management.",2020,"Both ACS and PRP treated patients showed improvement in pain intensity and knee function during 1 and 6 months pursue; however, this progress was more significant in the ACS group.","['Knee Osteoarthritis', '92 knee OA patients']","['autologous PRP', 'Dextrose prolotherapy', 'Dextrose Prolotherapy, Platelet Rich Plasma and Autologous Conditioned Serum', 'Dextrose prolotherapy, platelet-rich plasma (PRP) and autologous conditioned serum (ACS) injection', 'dextrose prolotherapy', 'ACS and PRP injections']","['Western Ontario and McMaster Universities (WOMAC) score, the visual analogue scale (VAS', 'level of pain and function in Knee OA', 'pain intensity and knee function', 'pain and function', 'pain reduction and knee function improvement']","[{'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0370220', 'cui_str': 'Platelet rich plasma'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0500223', 'cui_str': 'Prolotherapy'}, {'cui': 'C0009647', 'cui_str': 'Conditioning'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}]","[{'cui': 'C0029040', 'cui_str': 'Ontario'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0022742', 'cui_str': 'Bone structure of knee'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}]",92.0,0.0195675,"Both ACS and PRP treated patients showed improvement in pain intensity and knee function during 1 and 6 months pursue; however, this progress was more significant in the ACS group.","[{'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Pishgahi', 'Affiliation': 'Physical Medicine and Rehabilitation Research Center, Tabriz University of Medical Sciences, Tabriz, Iran. alirezapishgahi1364@gmail.com.'}, {'ForeName': 'Rozita', 'Initials': 'R', 'LastName': 'Abolhasan', 'Affiliation': 'Stem Cell Research Center, Tabriz University of Medical Sciences, Tabriz, Iran. roz.abolhasan20@gmail.com.'}, {'ForeName': 'Seyed Kazem', 'Initials': 'SK', 'LastName': 'Shakouri', 'Affiliation': 'Physical Medicine and Rehabilitation Research Center, Tabriz University of Medical Sciences, Tabriz, Iran. skshakouri@gmail.com.'}, {'ForeName': 'Mohammad Sadegh', 'Initials': 'MS', 'LastName': 'Soltani-Zangbar', 'Affiliation': 'Student Research Committee, Tabriz University of Medical Sciences, Tabriz, Iran. taher.s64@gmail.com.'}, {'ForeName': 'Shahla', 'Initials': 'S', 'LastName': 'Dareshiri', 'Affiliation': 'Physical Medicine and Rehabilitation Research Center, Tabriz University of Medical Sciences, Tabriz, Iran. shahladareshiri@gmail.com.'}, {'ForeName': 'Sepideh', 'Initials': 'S', 'LastName': 'Ranjbar Kiyakalayeh', 'Affiliation': 'Physical Medicine and Rehabilitation Research Center, Tabriz University of Medical Sciences, Tabriz, Iran. Sepide_r_k@yahoo.com.'}, {'ForeName': 'Amirghasem', 'Initials': 'A', 'LastName': 'Khoeilar', 'Affiliation': 'Stud Road Medical Centre, Dandenong, VIC, Australia. amirghasemkho@yahoo.com.'}, {'ForeName': 'Majid', 'Initials': 'M', 'LastName': 'Zamani', 'Affiliation': 'Department of Medical Laboratory Sciences, Faculty of Allied Medicine, Gonabad University of Medical Sciences, Gonabad, Iran. Majidzamani12@gmail.com.'}, {'ForeName': 'Farhad', 'Initials': 'F', 'LastName': 'Motavalli Khiavi', 'Affiliation': 'Medical Biotechnology Research Center, AJA University of Medical Sciences, Tehran, Iran. farhad.motavalli@gmail.com.'}, {'ForeName': 'Behzad', 'Initials': 'B', 'LastName': 'Pourabbas Kheiraddin', 'Affiliation': 'Department of Polymer Engineering, Sahand University of Technology, Tabriz, Iran. pourabas@sut.ac.ir.'}, {'ForeName': 'Amir', 'Initials': 'A', 'LastName': 'Mehdizadeh', 'Affiliation': 'Stem Cell Research Center, Tabriz University of Medical Sciences, Tabriz, Iran. Mehdizadeha@tbzmed.ac.ir.'}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Yousefi', 'Affiliation': 'Stem Cell Research Center, Tabriz University of Medical Sciences, Tabriz, Iran AND Department of Immunology, School of Medicine, Tabriz University of Medical Sciences, Tabriz, Iran. mehdi.yousefi1359@gmail.com.'}]","Iranian journal of allergy, asthma, and immunology",['10.18502/ijaai.v19i3.3452'] 2871,32615659,"Immunoregulatory Effects of Krocina™, a Herbal Medicine Made of Crocin, on Osteoarthritis Patients: A Successful Clinical Trial in Iran.","Osteoarthritis (OA) is the major cause of joint pain and disability. This research was planned to examine the effects of Krocina™, aherbal medicine made of crocin, an ingredient of saffron, in patients with OA. Forty patients suffering from OA were enrolled in our study and randomly divided into two groups, receiving Krocina™ and placebo, and the clinical trial continued for four months.Peripheral blood was taken from all patients and the percentage ofvarious subsets of T cells in addition to the levels of forkhead box protein P3 (FOXP3) and interleukin (IL)-17 were measured by flow cytometry technique. The visualan alog scale (VAS) index analysis decreased significantly in both groups (krocinaTM and placebo) (p<0.05). Assessment of the C-reactive protein (CRP) level in serum showed a significant decrease in the krocinaTM group (p<0.05). Moreover, we found a meaningful increase in the percentage of regulatory T cells (Tregs)cellin samples gathered from Krocina™ group (P=0.02) patients. The mean percentages of T helper (Th) 17 cellsinthe Krocina™ group and CD8+ T cellsin the placebo group patients were also meaningfully reduced (p<0.05). The geometric mean fluorescence intensity (GMFI) for IL-17 showed a significant decrease and increase in Krocina™ and placebo groups, respectively (p<0.05). No noticeable difference was observed in the percentages of Th cells and GMFI-FOXP3 in either group. Treg/Th17 ratio was shifted towards Tregscell in Krocina™ group at the end of the intervention. It is concluded that Krocina™ has immunoregulatory effects on patients with OA, ameliorating the disease.",2020,"The geometric mean fluorescence intensity (GMFI) for IL-17 showed a significant decrease and increase in Krocina™ and placebo groups, respectively (p<0.05).","['Osteoarthritis Patients', 'Iran', 'patients with OA', 'Forty patients suffering from OA']","['Krocina™ and placebo', 'C-reactive protein ', '17 cellsinthe Krocina™ group and CD8+ T cellsin', 'placebo']","['percentage of regulatory T cells', 'CRP) level', 'visualan alog scale (VAS) index analysis', 'Peripheral blood', 'mean percentages of T helper (Th', 'geometric mean fluorescence intensity (GMFI) for IL-17', 'percentages of Th cells and GMFI-FOXP3', 'forkhead box protein P3 (FOXP3) and interleukin (IL)-17']","[{'cui': 'C0029408', 'cui_str': 'Degenerative polyarthritis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0022065', 'cui_str': 'Iran'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0085358', 'cui_str': 'Lymphocyte antigen CD8'}]","[{'cui': 'C0439165', 'cui_str': 'Percent'}, {'cui': 'C0039198', 'cui_str': 'Regulatory T-Lymphocytes'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0229664', 'cui_str': 'Peripheral blood'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0016315', 'cui_str': 'Fluorescence'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0384648', 'cui_str': 'Interleukin 17'}, {'cui': 'C0018894', 'cui_str': 'Helper cell'}, {'cui': 'C0118111', 'cui_str': 'Forkhead Proteins'}]",40.0,0.0373166,"The geometric mean fluorescence intensity (GMFI) for IL-17 showed a significant decrease and increase in Krocina™ and placebo groups, respectively (p<0.05).","[{'ForeName': 'Javad', 'Initials': 'J', 'LastName': 'Poursamimi', 'Affiliation': 'Allergy Research Center, Mashhad University of Medical Sciences, Mashhad, Iran AND Department of Immunology, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran. poursj921@mums.ac.ir.'}, {'ForeName': 'Zhaleh', 'Initials': 'Z', 'LastName': 'Shariati-Sarabi', 'Affiliation': 'Rheumatic Diseases Research Center, Mashhad University of Medical Sciences, Mashhad, Iran AND Department of Internal Medicine, Imam Reza Hospital, Mashhad University of Medical Sciences, Mashhad, Iran. ShariatiJ@mums.ac.ir.'}, {'ForeName': 'Jalil', 'Initials': 'J', 'LastName': 'Tavakkol-Afshari', 'Affiliation': 'Department of Immunology, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran. tavakolaj@mums.ac.ir.'}, {'ForeName': 'Seyed Ahmad', 'Initials': 'SA', 'LastName': 'Mohajeri', 'Affiliation': 'Pharmaceutical Research Center, Pharmaceutical Technology Institute, Mashhad University of Medical Sciences, Mashhad, Iran. mohajeria@mums.ac.ir.'}, {'ForeName': 'Mohsen', 'Initials': 'M', 'LastName': 'Ghoryani', 'Affiliation': 'Department of Laboratory Sciences, School of Paramedical Sciences, Torbat Heydariyeh University of Medical Sciences, Torbat Heydariyeh, Iran AND Research Center of Advanced Technologies in Medicine, Torbat Heydariyeh University of Medical Sciences, Torbat Heydariyeh, Iran. Mohsen.ghoryani87@gmail.com.'}, {'ForeName': 'Mojgan', 'Initials': 'M', 'LastName': 'Mohammadi', 'Affiliation': 'Allergy Research Center, Mashhad University of Medical Sciences, Mashhad, Iran AND Department of Immunology, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran. Mohammadimzh@mums.ac.ir.'}]","Iranian journal of allergy, asthma, and immunology",['10.18502/ijaai.v19i3.3453'] 2872,32615663,"A Randomized, Triple-blind Placebo-controlled Trial to Determine the Effect of Saffron on the Serum Levels of MMP-9 and TIMP-1 in Patients with Multiple Sclerosis.","Matrix metalloproteinases (MMP)-9 facilitates the migration of T-cells to central nervous system (CNS), while tissue inhibitor of metalloproteinases-1(TIMP-1) inhibits the function of MMP-9. This study aimed to determine the appropriate treatment option for multiple sclerosis (MS). Forty-three relapsing-remitting MS (RRMS) patients were randomly divided into two groups of 22 (group A, placebo) and 21 (group B, Saffron pill) individuals. Serum samples were collected from patients' blood before using the Saffron pills/placebo pills and then after 12 months. The serum level of MMP-9 and its inhibitor, as well as TIMP-1, were measured by ELISA kits. MMP-9 serum levels noticeably decreased in patients with MS following 12 months of treatment with Saffron pills (p=0.006) while the changes were not significant before and after 12 months of treatment with placebo pills. Although the levels of TIMP-1 increased significantly after one year treating with Saffron pills (p=0.0002), a considerable difference was not observed before and after taking the placebo pills. The study finding revealed that 12-months treatment with Saffron could have a significant role in reducing the serum level of MMP-9 and increasing the serum level of TIMP-1 in RRMS patients. Therefore, modulating the serum levels of MMP-9 as an important regulator of T cell trafficking to the CNS might be a promising strategy in the treatment of MS patients.",2020,"The serum level of MMP-9 and its inhibitor, as well as TIMP-1, were measured by ELISA kits.","['Forty-three relapsing-remitting MS (RRMS) patients', 'multiple sclerosis (MS', 'Patients with Multiple Sclerosis']","['placebo', 'Placebo', 'Saffron']","['levels of TIMP-1', 'serum level of TIMP-1', 'serum level of MMP-9', 'serum level of MMP-9 and its inhibitor, as well as TIMP-1', 'MMP-9 serum levels', 'Serum Levels of MMP-9 and TIMP-1']","[{'cui': 'C0450368', 'cui_str': '43'}, {'cui': 'C0751967', 'cui_str': 'Relapsing remitting multiple sclerosis'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0026769', 'cui_str': 'Multiple sclerosis'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0162753', 'cui_str': 'Saffron Stain'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0145947', 'cui_str': 'Tissue inhibitor of metalloproteinases 1'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C4050026', 'cui_str': 'Matrix'}]",43.0,0.0496886,"The serum level of MMP-9 and its inhibitor, as well as TIMP-1, were measured by ELISA kits.","[{'ForeName': 'Fatemeh', 'Initials': 'F', 'LastName': 'Ghasemi Sakha', 'Affiliation': 'Department of Biology, Damghan Branch, Islamic Azad University, Damghan, Iran. sakha62@gmail.com.'}, {'ForeName': 'Amirreza', 'Initials': 'A', 'LastName': 'Azimi Saeen', 'Affiliation': 'Multiple Sclerosis Research Center, Neuroscience Institute, Tehran University of Medical Sciences, Tehran, Iran. amirreza_azimi@yahoo.com.'}, {'ForeName': 'Seyed Mohammad', 'Initials': 'SM', 'LastName': 'Moazzeni', 'Affiliation': 'Department of Immunology, Faculty of Medical Sciences, Tarbiat Modares University, Tehran, Iran. moazzeni@modares.ac.ir.'}, {'ForeName': 'Farnaz', 'Initials': 'F', 'LastName': 'Etesam', 'Affiliation': 'Psychosomatic Medicine Research Center, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran, Iran. fa.etesam@gmail.com.'}, {'ForeName': 'Gholamhassan', 'Initials': 'G', 'LastName': 'Vaezi', 'Affiliation': 'Department of Biology, Damghan Branch, Islamic Azad University, Damghan, Iran. gh.vaezi@yahoo.com.'}]","Iranian journal of allergy, asthma, and immunology",['10.18502/ijaai.v19i3.3457'] 2873,32615676,Repetitive Transcranial Magnetic Stimulation for Chronic Prostatitis/Chronic Pelvic Pain Syndrome: A Prospective Pilot Study.,"PURPOSE To evaluate the feasibility, efficacy, and safety of repetitive transcranial magnetic stimulation (rTMS) in patients with treatment-resistant chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS). METHODS Eleven patients with CP/CPPS were enrolled in this prospective clinical study. rTMS was performed for 5 consecutive days in 20-minute sessions. Patients were evaluated at baseline, after treatment, and at 1, 4, 8, and 12 weeks after the last session with questionnaires concerning pain (numerical rating scale [NRS], the National Institutes of Health Chronic Prostatitis Symptom Index [NIH-CPSI], and the Short Form-36 [SF-36]), urinary symptoms (NIH-CPSI, Danish Prostatic Symptom Score [DAN-PSS-1]), quality of life (NIH-CPSI, SF-36), and psychometrics (Beck Depression Index [BDI]). Telephone-based interviews were used to evaluate side effects, subjective response, and changes in drug consumption. RESULTS All patients completed the planned treatment and follow-up according to protocol. No patients experienced serious side effects or significant pain increase during or after treatment. Mild transient tension headache responsive to oral pain medication was reported by 2 patients. Decreased pain was observed on the NRS after treatment and at 1 and 8 weeks (P=0.019, P=0.006, P=0.042, respectively) and on the NIH-CPSI pain domain at 1 week (P=0.04). Improvement in lower urinary tract symptoms was observed after treatment in the NIH-CPSI urinary domain (P=0.02) but not with the DANPSS-1. No significant changes in the BDI were observed. Nine patients reported a positive overall subjective response (82%) and 6 patients (55%) were able to reduce pain medication. Higher age was associated with lower NRS scores after treatment (R=0.605, P=0.048) and at 8 weeks (R=0.659, P=0.028). CONCLUSION rTMS for patients with CP/CPPS seemed to be well tolerated, at least moderately effective in pain reduction, and might be of interest in patients with chronic pelvic pain resistant to conventional treatment. These findings remain to be confirmed by a randomized trial.",2020,"Decreased pain was observed on the NRS after treatment and at 1 and 8 weeks (P=0.019, P=0.006, P=0.042, respectively) and on the NIH-CPSI pain domain at 1 week (P=0.04).","['Chronic Prostatitis', 'Eleven patients with CP/CPPS', 'patients with chronic pelvic pain resistant to conventional treatment', 'patients with treatment-resistant chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS', 'Chronic Pelvic Pain Syndrome']","['repetitive transcranial magnetic stimulation (rTMS', 'rTMS', 'Repetitive Transcranial Magnetic Stimulation']","['pain (numerical rating scale [NRS], the National Institutes of Health Chronic Prostatitis Symptom Index [NIH-CPSI], and the Short Form-36 [SF-36]), urinary symptoms (NIH-CPSI, Danish Prostatic Symptom Score [DAN-PSS-1]), quality of life (NIH-CPSI, SF-36), and psychometrics (Beck Depression Index [BDI', 'lower NRS scores', 'Decreased pain', 'BDI', 'positive overall subjective response', 'pain medication', 'Mild transient tension headache responsive to oral pain medication', 'side effects, subjective response, and changes in drug consumption', 'feasibility, efficacy, and safety', 'NIH-CPSI pain domain', 'lower urinary tract symptoms', 'serious side effects or significant pain increase']","[{'cui': 'C0085696', 'cui_str': 'Chronic prostatitis'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0047123', 'cui_str': '3-(2-carboxypiperazin-4-yl)propyl-1-phosphonic acid'}, {'cui': 'C0404484', 'cui_str': 'Chronic pelvic pain of female'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1536168', 'cui_str': 'Chronic pelvic pain syndrome'}]","[{'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0027468', 'cui_str': 'United States National Institutes of Health'}, {'cui': 'C0085696', 'cui_str': 'Chronic prostatitis'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0426359', 'cui_str': 'Urinary symptoms'}, {'cui': 'C0010969', 'cui_str': 'Danish language'}, {'cui': 'C0033572', 'cui_str': 'Prostatic'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0010961', 'cui_str': 'Danazol'}, {'cui': 'C0582653', 'cui_str': 'Perceived stress scale'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0033920', 'cui_str': 'Psychometric testing'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0006448', 'cui_str': 'Burundi'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205216', 'cui_str': 'Decreased'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0439655', 'cui_str': 'Subjective'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}, {'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0040704', 'cui_str': 'Transients'}, {'cui': 'C0033893', 'cui_str': 'Psychogenic headache'}, {'cui': 'C0205342', 'cui_str': 'Responsive'}, {'cui': 'C0221776', 'cui_str': 'Painful mouth'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0574785', 'cui_str': 'Lower urinary tract symptoms'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0205217', 'cui_str': 'Increased'}]",11.0,0.0245363,"Decreased pain was observed on the NRS after treatment and at 1 and 8 weeks (P=0.019, P=0.006, P=0.042, respectively) and on the NIH-CPSI pain domain at 1 week (P=0.04).","[{'ForeName': 'Jussi', 'Initials': 'J', 'LastName': 'Nikkola', 'Affiliation': 'Department of Urology, Tampere University Hospital, Tampere, Finland.'}, {'ForeName': 'Anu', 'Initials': 'A', 'LastName': 'Holm', 'Affiliation': 'Unit of Clinical Neurophysiology, Satakunta Hospital District, Pori, Finland.'}, {'ForeName': 'Marjo', 'Initials': 'M', 'LastName': 'Seppänen', 'Affiliation': 'Department of Urology, Tampere University Hospital, Tampere, Finland.'}, {'ForeName': 'Teemu', 'Initials': 'T', 'LastName': 'Joutsi', 'Affiliation': 'Department of Urology, Tampere University Hospital, Tampere, Finland.'}, {'ForeName': 'Esa', 'Initials': 'E', 'LastName': 'Rauhala', 'Affiliation': 'Unit of Clinical Neurophysiology, Satakunta Hospital District, Pori, Finland.'}, {'ForeName': 'Antti', 'Initials': 'A', 'LastName': 'Kaipia', 'Affiliation': 'Department of Surgery, Satakunta Hospital District, Pori, Finland.'}]",International neurourology journal,['10.5213/inj.1938258.129'] 2874,32615794,Effects of deep and slow breathing on stress stimulation caused by high-intensity exercise in healthy adults.,"The purpose of this study was to investigate the effects of the deep and slow breathing (DSB) on the chain-reaction changes of stress stimulation at over time by measuring electroencephalogram (EEG) and heart rate variability (HRV). Twenty-six healthy subjects were divided into two different groups: control group (CG) and DSB group (DSBG). All subjects were exposed to a stress-stimulated environment with 80% exercise intensity. After the 80% exercise intensity was maintained for 10 minutes, the subjects rested for 5 minutes and then measuring EEG and HRV. The chain-reaction changes of stress stimulation through EEG and HRV analysis showed that DSBG had higher values of alpha/high-beta ratio and High-Frequency (HF) value of HRV than CG (p <.05), and Low-Frequency/High-Frequency (LF/HF) ratio of DSBG is significant time-group interaction, indicating a significant difference between groups (p <.05). In consequence, DSB will be used as a meaningful intervention for patients of stress-related diseases or potential patients.",2020,"The chain-reaction changes of stress stimulation through EEG and HRV analysis showed that DSBG had higher values of alpha/high-beta ratio and High-Frequency (HF) value of HRV than CG (p <.05), and Low-Frequency/High-Frequency (LF/HF) ratio of DSBG is significant time-group interaction, indicating a significant difference between groups (p <.05).","['patients of stress-related diseases or potential patients', 'Twenty-six healthy subjects', 'healthy adults']","['deep and slow breathing', 'control group (CG) and DSB group (DSBG', 'deep and slow breathing (DSB']","['values of alpha/high-beta ratio and High-Frequency (HF) value of HRV', 'electroencephalogram (EEG) and heart rate variability (HRV']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0450349', 'cui_str': '26'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C0205125', 'cui_str': 'Deep'}, {'cui': 'C0231837', 'cui_str': 'Slow respiration'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0603200', 'cui_str': '1,2-di-(4-sulfamidophenyl)-4-butylpyrazolidine-3,5-dione'}]","[{'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0330390', 'cui_str': 'Beta'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0205212', 'cui_str': 'High frequency'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}]",26.0,0.0232198,"The chain-reaction changes of stress stimulation through EEG and HRV analysis showed that DSBG had higher values of alpha/high-beta ratio and High-Frequency (HF) value of HRV than CG (p <.05), and Low-Frequency/High-Frequency (LF/HF) ratio of DSBG is significant time-group interaction, indicating a significant difference between groups (p <.05).","[{'ForeName': 'Su-Ha', 'Initials': 'SH', 'LastName': 'Lee', 'Affiliation': 'Department of Physical Therapy, The Graduate School, Konyang University , Daejeon, Republic of Korea.'}, {'ForeName': 'Hee-Ji', 'Initials': 'HJ', 'LastName': 'Lee', 'Affiliation': 'Department of Physical Therapy, The Graduate School, Konyang University , Daejeon, Republic of Korea.'}, {'ForeName': 'Dae-Sung', 'Initials': 'DS', 'LastName': 'Park', 'Affiliation': 'Department of Physical Therapy, College of Medical Science, Konyang University , Daejeon, Republic of Korea.'}]","Psychology, health & medicine",['10.1080/13548506.2020.1786138'] 2875,32615798,Incidence and Factors Associated With Major Amputation in Patients With Peripheral Artery Disease: Insights From the EUCLID Trial.,"Background Peripheral artery disease (PAD) is associated with increased risk of mortality, cardiovascular morbidity, and major amputation. Data on major amputation from a large randomized trial that included a substantial cohort of patients without critical limb ischemia (CLI) have not been described. The objective was to describe the incidence and types of amputations in the EUCLID trial (Examining Use of Ticagrelor in Peripheral Artery Disease) population, subcategorize amputations in the CLI versus no CLI cohorts, and describe the events surrounding major amputation. Methods and Results Postrandomization major amputation was analyzed in the EUCLID trial. Patients were stratified by baseline CLI status. The occurrence of major amputation was ascertained and defined as the highest level. Perioperative events surrounding major amputation were obtained including acute limb ischemia, revascularization, and all-cause mortality. All variables were assessed for significance in univariable and multivariable models. The rate of major amputation during the course of the trial was 1.6% overall, 8.4% in the CLI at baseline group, and 1.2% in the no CLI at baseline group. The annualized rate of major amputation was 0.6% in PAD overall, 3.9% in the CLI at baseline group, and 0.5% in the no CLI at baseline group. Several factors were associated with increased risk of major amputation, including history of amputation, the presence of diabetes mellitus, baseline Rutherford category 4 to 6, and an ankle-brachial index <0.8. Factors associated with a lower risk for major amputation included prior statin use. The 30-day mortality rate after major amputation was 6.5% overall, 5.6% in the CLI at baseline group, and 6.8% in the no CLI at baseline group. The annual mortality rate following major amputation was 22.8% in the CLI at baseline group and 16.0% in the no CLI at baseline group. Conclusions The risk factors for major amputation in EUCLID patients are similar to previous large registries' reports except for diabetes mellitus in patients with CLI. The mortality following major amputation is lower in the Examining Use of Ticagrelor in Peripheral Artery Disease trial compared with registry data. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT01732822.",2020,"The 30-day mortality rate after major amputation was 6.5% overall, 5.6% in the CLI at baseline group, and 6.8% in the no CLI at baseline group.","['patients with CLI', 'patients without critical limb ischemia (CLI', 'Patients With Peripheral Artery Disease']",['Ticagrelor'],"['occurrence of major amputation', 'risk of major amputation, including history of amputation, the presence of diabetes mellitus', '30-day mortality rate after major amputation', 'annualized rate of major amputation', 'rate of major amputation', 'annual mortality rate following major amputation', 'risk of mortality, cardiovascular morbidity, and major amputation', 'acute limb ischemia, revascularization, and all-cause mortality']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1142264', 'cui_str': 'Critical limb ischemia'}, {'cui': 'C1704436', 'cui_str': 'Peripheral Arterial Diseases'}]","[{'cui': 'C1999375', 'cui_str': 'Ticagrelor'}]","[{'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0002688', 'cui_str': 'Amputation'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0262926', 'cui_str': 'History of'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0332181', 'cui_str': 'Annual'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C1301700', 'cui_str': 'Cardiovascular morbidity'}, {'cui': 'C4049535', 'cui_str': 'Acute limb ischaemia'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action'}]",,0.0731566,"The 30-day mortality rate after major amputation was 6.5% overall, 5.6% in the CLI at baseline group, and 6.8% in the no CLI at baseline group.","[{'ForeName': 'Chandler A', 'Initials': 'CA', 'LastName': 'Long', 'Affiliation': 'Department of Surgery, Division of Vascular Surgery and Endovascular Surgery, Duke University Health System, Durham, NC. (C.A.L.).'}, {'ForeName': 'Hillary', 'Initials': 'H', 'LastName': 'Mulder', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (H.M., F.W.R., M.R.P., W.S.J.).'}, {'ForeName': 'F Gerry R', 'Initials': 'FGR', 'LastName': 'Fowkes', 'Affiliation': 'Usher Institute of Population Health Sciences and Informatics, University of Edinburgh, United Kingdom (F.G.R.F.).'}, {'ForeName': 'Iris', 'Initials': 'I', 'LastName': 'Baumgartner', 'Affiliation': 'Division of Angiology, Swiss Cardiovascular Centre, Inselspital, Bern University Hospital, University of Bern, Switzerland (I.B.).'}, {'ForeName': 'Jeffrey S', 'Initials': 'JS', 'LastName': 'Berger', 'Affiliation': 'Department of Medicine, New York University School of Medicine. (J.S.B.).'}, {'ForeName': 'Brian G', 'Initials': 'BG', 'LastName': 'Katona', 'Affiliation': 'AstraZeneca Gaithersburg, MD (B.G.K.).'}, {'ForeName': 'Kenneth W', 'Initials': 'KW', 'LastName': 'Mahaffey', 'Affiliation': 'Stanford Center for Clinical Research, Stanford University School of Medicine, CA (K.W.M.).'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Norgren', 'Affiliation': 'Faculty of Medicine and Health, örebro University, Sweden (L.N.).'}, {'ForeName': 'Juuso I', 'Initials': 'JI', 'LastName': 'Blomster', 'Affiliation': 'Heart Centre, Turku University Hospital, University of Turku, Finland (J.I.B.).'}, {'ForeName': 'Frank W', 'Initials': 'FW', 'LastName': 'Rockhold', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (H.M., F.W.R., M.R.P., W.S.J.).'}, {'ForeName': 'William R', 'Initials': 'WR', 'LastName': 'Hiatt', 'Affiliation': 'Department of Medicine, Division of Cardiology, University of Colorado School of Medicine and CPC Clinical Research, Aurora. (W.R.H.).'}, {'ForeName': 'Manesh R', 'Initials': 'MR', 'LastName': 'Patel', 'Affiliation': 'Department of Medicine, Division of Cardiology, Duke University Health System, Durham, NC. (M.R.P., W.S.J.).'}, {'ForeName': 'W Schuyler', 'Initials': 'WS', 'LastName': 'Jones', 'Affiliation': 'Department of Medicine, Division of Cardiology, Duke University Health System, Durham, NC. (M.R.P., W.S.J.).'}, {'ForeName': 'Mark R', 'Initials': 'MR', 'LastName': 'Nehler', 'Affiliation': 'Department of Surgery, Division of Vascular Surgery and Endovascular Surgery, University of Colorado School of Medicine and CPC Clinical Research, Aurora. (M.R.N.).'}]",Circulation. Cardiovascular quality and outcomes,['10.1161/CIRCOUTCOMES.119.006399'] 2876,32615837,"Efficacy of a vaginal tablet as a Persian medicine product on vulvovaginal candidiasis: a double-blind, randomised, placebo-controlled trial.","Context: In Persian medicine, topical ingredients such as Rosa damascena Mill. (Rosaceae), are usually recommended for the treatment of uterine diseases. Scientific evaluation of these historical documents can be valuable for finding new potential use in conventional medicine. Objective: This clinical trial was performed to determine whether the use of the 'ward' vaginal tablet, which contains Rosa damascena, Punica granatum L. (Punicaceae), Querqus infectoria Oliv. (Fagaceae), Myrtus communis L. (Myrtaceae) and Nardostachys jatamansi (D.Don) DC. (Caprifoliaceae) could alleviate the symptoms of vulvovaginal candidiasis. Materials and methods: A parallel double-blinded placebo-controlled study was done. Eighteen to fifty-year-old women with vulvovaginal candidiasis were divided into the 'ward' and placebo groups, 46 individuals in each group. The 'ward' group received the 'ward' vaginal tablet containing 200 mg of dried extract. Placebo group received a placebo (composed of corn starch and lactose). One tablet was applied through the vagina for 7 consecutive nights. Results: Two weeks after medication administration, the vaginal discharge sample of patients was re-cultured; 29 patients (63.045%) in the 'ward' group and 6 (13.04%) patients in the placebo group had negative culture ( p  < 0.001). All clinical symptoms including itching, irritation, and vaginal discharge were significantly reduced in the 'ward' group compared with the placebo group following the intervention and the follow up ( p  < 0.05). Discussion and conclusions: The findings suggest the 'ward' vaginal tablet could ameliorate vulvovaginal candidiasis. Future larger studies are recommended due to compare the therapeutic effect of the 'ward' vaginal tablet with common treatments.",2020,"All clinical symptoms including itching, irritation, and vaginal discharge were significantly reduced in the 'ward' group compared with the placebo group following the intervention and the follow up ( p  < 0.05).","['Eighteen to fifty-year-old women with vulvovaginal candidiasis', 'groups, 46 individuals in each group']","['Placebo', 'vaginal tablet', 'placebo (composed of corn starch and lactose', ""ward' vaginal tablet containing 200\u2009mg of dried extract"", 'placebo']","['Fagaceae), Myrtus communis L. (Myrtaceae) and Nardostachys jatamansi (D.Don) DC', 'vaginal discharge sample', 'vulvovaginal candidiasis', 'symptoms of vulvovaginal candidiasis', 'itching, irritation, and vaginal discharge', 'negative culture']","[{'cui': 'C3715206', 'cui_str': '18'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0700345', 'cui_str': 'Candidal vulvovaginitis'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0042264', 'cui_str': 'Vaginal tablet'}, {'cui': 'C1384515', 'cui_str': 'corn starch'}, {'cui': 'C0022949', 'cui_str': 'Lactose'}, {'cui': 'C1305702', 'cui_str': 'Ward'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C1720167', 'cui_str': 'Dry extract'}]","[{'cui': 'C0950075', 'cui_str': 'Family Fagaceae'}, {'cui': 'C3853725', 'cui_str': 'Myrtus communis whole extract'}, {'cui': 'C1021351', 'cui_str': 'Nardostachys'}, {'cui': 'C0227791', 'cui_str': 'Vaginal discharge'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0700345', 'cui_str': 'Candidal vulvovaginitis'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0441723', 'cui_str': 'Irritation'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0010453', 'cui_str': 'Culture'}]",,0.311822,"All clinical symptoms including itching, irritation, and vaginal discharge were significantly reduced in the 'ward' group compared with the placebo group following the intervention and the follow up ( p  < 0.05).","[{'ForeName': 'Somayyeh', 'Initials': 'S', 'LastName': 'Khalilzadeh', 'Affiliation': 'Department of Persian Medicine, School of Persian Medicine, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Tahereh', 'Initials': 'T', 'LastName': 'Eftkhar', 'Affiliation': 'Department of Obstetrics and Gynecology, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Laila', 'Initials': 'L', 'LastName': 'Shirbeigi', 'Affiliation': 'Department of Persian Medicine, School of Persian Medicine, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Malihe', 'Initials': 'M', 'LastName': 'Tabarrai', 'Affiliation': 'Department of Persian Medicine, School of Persian Medicine, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Tayebeh', 'Initials': 'T', 'LastName': 'Toliyat', 'Affiliation': 'Department of Pharmaceutics, Faculty of Pharmacy, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Shamim', 'Initials': 'S', 'LastName': 'Fayazmanesh', 'Affiliation': 'Department of Pharmaceutics, Faculty of Pharmacy, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Zeinab', 'Initials': 'Z', 'LastName': 'Ghasemi', 'Affiliation': 'Medical Mycology of Razi Hospital, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Safar', 'Initials': 'S', 'LastName': 'Shamohammadi', 'Affiliation': 'Razi Hospital Laboratory, Faculty member in medicine, Tehran University of Medical Sciences, Tehran, Iran.'}]",Pharmaceutical biology,['10.1080/13880209.2020.1784236'] 2877,32615892,[The Effect of a Short-Term Mindfulness Program on Memory Performance in School-Aged Children].,"The Effect of a Short-Term Mindfulness Program on Memory Performance in School-Aged Children A one-week mindfulness-based intervention designed to improve 8- to 10-year-old children's memory performance was investigated. Seventy-three children were quasi-randomly assigned either to one of two mindfulness-based intervention groups (breathing meditation or yoga), or to an active control group. The sessions were held on six consecutive days. Prior to intervention and after completing the intervention, children's short-term and long-term memory performance were assessed. In confirmation of prior studies, breathing meditation and yoga showed positive effects on memory performance when compared with the control group. Moreover, differences in the effectiveness of breathing meditation and yoga were found: While both interventions had comparable effects on long-term memory, only breathing meditation showed improvements in short-term memory performance. The present study provides valuable evidence on the effectiveness of meditation on cognitive functions in childhood and shows that school-aged children can already benefit from short-term meditation programs.",2020,"In confirmation of prior studies, breathing meditation and yoga showed positive effects on memory performance when compared with the control group.","['School-Aged Children', 'school-aged children', 'Seventy-three children']","['Short-Term Mindfulness Program', 'mindfulness-based intervention groups (breathing meditation or yoga), or to an active control group']","['short-term memory performance', 'memory performance', 'Memory Performance']","[{'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C3816957', 'cui_str': '70'}]","[{'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}, {'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0561844', 'cui_str': 'Short-term memory performance'}, {'cui': 'C1285654', 'cui_str': 'Memory performance'}]",73.0,0.0165485,"In confirmation of prior studies, breathing meditation and yoga showed positive effects on memory performance when compared with the control group.","[{'ForeName': 'Corina', 'Initials': 'C', 'LastName': 'Möller', 'Affiliation': 'Universität des Saarlandes Campus A1.3 66123 Saarbrücken Deutschland Universität des Saarlandes.'}, {'ForeName': 'Gisa', 'Initials': 'G', 'LastName': 'Aschersleben', 'Affiliation': 'Universität des Saarlandes Campus A1.3 66123 Saarbrücken Deutschland Universität des Saarlandes.'}]",Praxis der Kinderpsychologie und Kinderpsychiatrie,['10.13109/prkk.2020.69.4.305'] 2878,32616022,Sources of potential bias when combining routine data linkage and a national survey of secondary school-aged children: a record linkage study.,"BACKGROUND Linking survey data to administrative records requires informed participant consent. When linkage includes child data, this includes parental and child consent. Little is known of the potential impacts of introducing consent to data linkage on response rates and biases in school-based surveys. This paper assessed: i) the impact on overall parental consent rates and sample representativeness when consent for linkage was introduced and ii) the quality of identifiable data provided to facilitate linkage. METHODS Including an option for data linkage was piloted in a sub-sample of schools participating in the Student Health and Wellbeing survey, a national survey of adolescents in Wales, UK. Schools agreeing to participate were randomized 2:1 to receive versus not receive the data linkage question. Survey responses from consenting students were anonymised and linked to routine datasets (e.g. general practice, inpatient, and outpatient records). Parental withdrawal rates were calculated for linkage and non-linkage samples. Multilevel logistic regression models were used to compare characteristics between: i) consenters and non-consenters; ii) successfully and unsuccessfully linked students; and iii) the linked cohort and peers within the general population, with additional comparisons of mental health diagnoses and health service contacts. RESULTS The sub-sample comprised 64 eligible schools (out of 193), with data linkage piloted in 39. Parental consent was comparable across linkage and non-linkage schools. 48.7% (n = 9232) of students consented to data linkage. Modelling showed these students were more likely to be younger, more affluent, have higher positive mental wellbeing, and report fewer risk-related behaviours compared to non-consenters. Overall, 69.8% of consenting students were successfully linked, with higher rates of success among younger students. The linked cohort had lower rates of mental health diagnoses (5.8% vs. 8.8%) and specialist contacts (5.2% vs. 7.7%) than general population peers. CONCLUSIONS Introducing data linkage within a national survey of adolescents had no impact on study completion rates. However, students consenting to data linkage, and those successfully linked, differed from non-consenting students on several key characteristics, raising questions concerning the representativeness of linked cohorts. Further research is needed to better understand decision-making processes around providing consent to data linkage in adolescent populations.",2020,"The linked cohort had lower rates of mental health diagnoses (5.8% vs. 8.8%) and specialist contacts (5.2% vs. 7.7%) than general population peers. ","['secondary school-aged children', '64 eligible schools (out of 193), with data linkage piloted in 39', 'consenting students were anonymised and linked to routine datasets (e.g. general practice, inpatient, and outpatient records', 'cohort and peers within the general population, with additional comparisons of mental health diagnoses and health service contacts', 'Including an option for data linkage was piloted in a sub-sample of schools participating in the Student Health and Wellbeing survey, a national survey of adolescents in Wales, UK']",[],"['mental health diagnoses', 'positive mental wellbeing', 'Parental withdrawal rates', 'specialist contacts']","[{'cui': 'C0036530', 'cui_str': 'Secondary school'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0242239', 'cui_str': 'Data Linkage'}, {'cui': 'C0473169', 'cui_str': 'Pilot - aircraft'}, {'cui': 'C2711213', 'cui_str': 'Consented'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0150098', 'cui_str': 'Data Set'}, {'cui': 'C0015607', 'cui_str': 'Family practice'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0009247', 'cui_str': 'Concurrent Studies'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0018747', 'cui_str': 'Services, Health'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0043015', 'cui_str': 'Wales'}]",[],"[{'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C0087009', 'cui_str': 'Hospital specialist'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}]",,0.0463772,"The linked cohort had lower rates of mental health diagnoses (5.8% vs. 8.8%) and specialist contacts (5.2% vs. 7.7%) than general population peers. ","[{'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Morgan', 'Affiliation': 'Centre for the Development and Evaluation of Complex Interventions for Public Health Improvement (DECIPHer), School of Social Sciences, Cardiff University, Cardiff, CF10 3BD, UK. morgank22@cardiff.ac.uk.'}, {'ForeName': 'Nicholas', 'Initials': 'N', 'LastName': 'Page', 'Affiliation': 'Centre for the Development and Evaluation of Complex Interventions for Public Health Improvement (DECIPHer), School of Social Sciences, Cardiff University, Cardiff, CF10 3BD, UK.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Brown', 'Affiliation': 'Centre for the Development and Evaluation of Complex Interventions for Public Health Improvement (DECIPHer), School of Social Sciences, Cardiff University, Cardiff, CF10 3BD, UK.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Long', 'Affiliation': 'Centre for the Development and Evaluation of Complex Interventions for Public Health Improvement (DECIPHer), School of Social Sciences, Cardiff University, Cardiff, CF10 3BD, UK.'}, {'ForeName': 'Gillian', 'Initials': 'G', 'LastName': 'Hewitt', 'Affiliation': 'Centre for the Development and Evaluation of Complex Interventions for Public Health Improvement (DECIPHer), School of Social Sciences, Cardiff University, Cardiff, CF10 3BD, UK.'}, {'ForeName': 'Marcos', 'Initials': 'M', 'LastName': 'Del Pozo-Banos', 'Affiliation': 'Swansea University Medical School, Swansea University, Swansea, UK.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'John', 'Affiliation': 'Swansea University Medical School, Swansea University, Swansea, UK.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Murphy', 'Affiliation': 'Centre for the Development and Evaluation of Complex Interventions for Public Health Improvement (DECIPHer), School of Social Sciences, Cardiff University, Cardiff, CF10 3BD, UK.'}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'Moore', 'Affiliation': 'Centre for the Development and Evaluation of Complex Interventions for Public Health Improvement (DECIPHer), School of Social Sciences, Cardiff University, Cardiff, CF10 3BD, UK.'}]",BMC medical research methodology,['10.1186/s12874-020-01064-1'] 2879,32616026,Single dose versus 24 h antibiotic prophylaxis in reduction mammaplasty: study protocol for a randomized controlled trial.,"BACKGROUND Reduction mammaplasty is among the most commonly performed procedures in plastic surgery. Antibiotics are widely prescribed, on an empirical basis, to prevent surgical site infections. However, there is a lack of evidence to support its use. This trial aims to compare the influence of the use of prophylatic antibiotics as a single dose or for 24 h on surgical site infection rates following reduction mammaplasty. METHODS Randomized trial of non-inferiority, with two parallel groups. A total of 146 breast hypertrophy patients, with reduction mammaplasty already scheduled, will be enrolled. Patients will be randomly allocated to the placebo group that will receive antibiotics only at the anesthesia induction (n = 73) or to the antibiotics group that will receive antibiotics at the anesthesia induction and for 24 h (n = 73). None of the patients will receive antibiotics after hospital discharge. Patients will be followed-up weekly, for 30 days, regarding surgical site infection. The Centers for Disease Control and Prevention criteria will be applied. A statistical analysis of the data will be performed. DISCUSSION Previous studies have demonstrated a decrease in infection rates after reduction mammaplasty when antibiotic prophylaxis was used, compared to the use of no antibiotics. However, the duration of antibiotic prophylaxis remains a point to be clarified. This study will test the hypothesis that maintaining the use of antibiotics for 24 h does not reduce infection rates compared to the use of a single preoperative dose. TRIAL REGISTRATION Clinicaltrials.gov NCT04079686 . Registered on September 6, 2019.",2020,"Previous studies have demonstrated a decrease in infection rates after reduction mammaplasty when antibiotic prophylaxis was used, compared to the use of no antibiotics.","['146 breast hypertrophy patients, with reduction mammaplasty already scheduled, will be enrolled']","['antibiotics group that will receive antibiotics at the anesthesia induction', '24\u2009h antibiotic prophylaxis', 'prophylatic antibiotics', 'placebo']",['infection rates'],"[{'cui': 'C0020565', 'cui_str': 'Hypertrophy of breast'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0191922', 'cui_str': 'Reduction mammoplasty'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}]","[{'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0473960', 'cui_str': 'Induction of general anesthesia'}, {'cui': 'C0282638', 'cui_str': 'Antibiotic prophylaxis'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0009450', 'cui_str': 'Communicable disease'}]",146.0,0.171198,"Previous studies have demonstrated a decrease in infection rates after reduction mammaplasty when antibiotic prophylaxis was used, compared to the use of no antibiotics.","[{'ForeName': 'Daniela Francescato', 'Initials': 'DF', 'LastName': 'Veiga', 'Affiliation': 'Translational Surgery Graduate Program, Universidade Federal de São Paulo, São Paulo, Brazil. danielafveiga@gmail.com.'}, {'ForeName': 'Edgard', 'Initials': 'E', 'LastName': 'da Silva Garcia', 'Affiliation': 'Division of Plastic Surgery, Department of Surgery, Universidade do Vale do Sapucaí, Pouso Alegre, Brazil.'}, {'ForeName': 'José Wilson', 'Initials': 'JW', 'LastName': 'Moreira-Filho', 'Affiliation': 'Division of Plastic Surgery, Department of Surgery, Universidade do Vale do Sapucaí, Pouso Alegre, Brazil.'}, {'ForeName': 'Evelyne Borges', 'Initials': 'EB', 'LastName': 'de Mattos Andrade', 'Affiliation': 'Division of Plastic Surgery, Department of Surgery, Universidade do Vale do Sapucaí, Pouso Alegre, Brazil.'}, {'ForeName': 'Yara', 'Initials': 'Y', 'LastName': 'Juliano', 'Affiliation': 'Department of Bioestatistics, Universidade Federal de São Paulo, and Universidade de Santo Amaro, São Paulo, Brazil.'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Veiga-Filho', 'Affiliation': 'Division of Plastic Surgery, Department of Surgery, Universidade do Vale do Sapucaí, Pouso Alegre, Brazil.'}, {'ForeName': 'Lydia Masako', 'Initials': 'LM', 'LastName': 'Ferreira', 'Affiliation': 'Translational Surgery Graduate Program, Universidade Federal de São Paulo, São Paulo, Brazil.'}]",Trials,['10.1186/s13063-020-04539-0'] 2880,32616063,Hydroxychloroquine efficacy and safety in preventing SARS-CoV-2 infection and COVID-19 disease severity during pregnancy (COVID-Preg): a structured summary of a study protocol for a randomised placebo controlled trial.,"OBJECTIVES The primary objectives of the study are: 1. To assess the effect of hydroxychloroquine (HCQ) in reducing SARS-CoV-2 viral shedding by PCR in infected pregnant women with mild symptoms. 2. To assess the efficacy of HCQ to prevent SARS-CoV-2 infection in pregnant women in contact with an infected or suspected case. 3. To evaluate the effect of HCQ in preventing the development of the COVID-19 disease in asymptomatic SARS-CoV-2-infected pregnant women. The secondary objectives are: 1. To determine the effect of HCQ on the clinical course and duration of the COVID-19 disease in SARS-CoV-2-infected pregnant women. 2. To determine the impact of HCQ on the risk of hospitalization and mortality of SARS-CoV-2-infected pregnant women. 3. To assess the safety and tolerability of HCQ in pregnant women. 4. To describe the clinical presentation of SARS-CoV-2 infection during pregnancy. 5. To describe the effects of maternal SARS-CoV-2 infection on pregnancy and perinatal outcomes by treatment group. 6. To determine the risk of vertical transmission (intra-utero and intra-partum) of SARS-CoV-2. TRIAL DESIGN Randomized double-blind placebo-controlled two-arm multicentre clinical trial to evaluate the safety and efficacy of HCQ to prevent and/or minimize SARS-CoV-2 infection during pregnancy. Participants will be randomized to receive a 14-day oral treatment course of HCQ or placebo, ratio 1:1. PARTICIPANTS Study population: pregnant women undergoing routine prenatal follow up or attending emergency units at the participating hospitals who report either symptoms/signs suggestive of COVID-19 disease or close contact with a suspected or confirmed COVID-19 case. Inclusion criteria Women will be invited to participate in the trial and sign an informed consent if they meet the following inclusion criteria. • Presenting with fever (≥37.5°C) and/or one mild symptom suggestive of COVID-19 disease (cough, dyspnoea, chills, odynophagia, diarrhoea, muscle pain, anosmia, dysgeusia, headache) OR being contact* of a SARS-CoV-2 confirmed or suspected case in the past 14 days • More than 12 weeks of gestation (dated by ultrasonography) • Agreement to deliver in the study hospitals Exclusion criteria • Known hypersensitivity to HCQ or other 4-amonoquinoline compounds • History of retinopathy of any aetiology • Concomitant use of digoxin, cyclosporine, cimetidine • Known liver disease • Clinical history of cardiac pathology including known long QT syndrome • Unable to cooperate with the requirements of the study • Participating in other intervention studies • Delivery onset (characterized by painful uterine contractions and variable changes of the cervix, including some degree of effacement and slower progression of dilatation up to 5 cm for first and subsequent labours) The study participants will be stratified by clinical presentation and SARS-CoV-2 PCR results. Assignment of participants to study groups will be as follows: • SARS-CoV-2-PCR confirmed, infected pregnant women: a. symptomatic (n=100) b. asymptomatic (n=100) • SARS-CoV-2 PCR negative pregnant women in contact* with a SARS-CoV-2-infected confirmed or suspected case (n=514). *The ECDC definition of close contact will be followed. The trial will be conducted in five hospitals in Spain: Hospital Clínic of Barcelona, Hospital Sant Joan de Déu and Hospital de la Santa Creu i Sant Pau, in Barcelona, and HM Puerta del Sur and Hospital Universitario de Torrejón, in Madrid. INTERVENTION AND COMPARATOR Participants will be randomized to HCQ (400 mg/day for three days, followed by 200 mg/day for 11 days) or placebo (2 tablets for three days, followed by one tablet for 11 days). MAIN OUTCOMES The primary outcome is the number of PCR-confirmed infected pregnant women assessed from collected nasopharyngeal and oropharyngeal swabs at day 21 after treatment start (one week after treatment is completed). RANDOMISATION Allocation of participants to study arms will be done centrally by the trial's Sponsor (the Barcelona Institute for Global Health, ISGlobal) by block randomization. This method will ensure balanced allocation to both arms. The electronic CRF will automatically assign a study number to each participant, depending on her study group and recruitment site. Each number will be related to a treatment number, which assigns them to one of the study arms. BLINDING (MASKING) Participants, caregivers, investigators and those assessing the outcomes will be blinded to group assignment. Study tablets (HCQ and placebo) will be identically packaged in small opaque bottles. NUMBERS TO BE RANDOMISED (SAMPLE SIZE) This study requires 200 SARS-CoV-2 infected and 514 contact pregnant women, randomised 1:1 with 100 and 227 respectively in each study arm. TRIAL STATUS Protocol version 1.0, from May 8 th , 2020. Recruitment is ongoing (first patient recruited the 19 th May 2020 and recruitment end anticipated by December 2020). TRIAL REGISTRATION EudraCT number: 2020-001587-29, registered 2 April 2020. Clinicaltrials.gov identifier: NCT04410562 , retrospectively registered 1 June 2020. FULL PROTOCOL The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.",2020,To assess the efficacy of HCQ to prevent SARS-CoV-2 infection in pregnant women in contact with an infected or suspected case.,"['2020-001587-29, registered 2 April 2020', 'b. asymptomatic (n=100', 'five hospitals in Spain: Hospital Clínic of Barcelona, Hospital Sant Joan de Déu and Hospital de la', 'Study population: pregnant women undergoing routine prenatal follow up or attending emergency units at the participating hospitals who report either symptoms/signs suggestive of COVID-19 disease or close contact with a suspected or confirmed COVID-19 case', 'SARS-CoV-2 infection and COVID-19 disease severity during pregnancy (COVID-Preg', '200 SARS-CoV-2 infected and 514 contact pregnant women, randomised 1:1 with 100 and 227 respectively in each study arm', 'SARS-CoV-2-infected pregnant women', 'pregnant women in contact with an infected or suspected case', 'asymptomatic SARS-CoV-2-infected pregnant women', 'infected pregnant women with mild symptoms', 'infected pregnant women: a. symptomatic (n=100', 'pregnant women']","['Santa Creu', 'cimetidine', 'Hydroxychloroquine', 'HCQ', 'hydroxychloroquine (HCQ', 'maternal SARS-CoV-2 infection', 'Study tablets (HCQ and placebo', 'digoxin, cyclosporine', 'HCQ or placebo, ratio 1:1', '4-amonoquinoline', 'gestation (dated by ultrasonography', 'placebo']","['mild symptom suggestive of COVID-19 disease (cough, dyspnoea, chills, odynophagia, diarrhoea, muscle pain, anosmia, dysgeusia, headache', 'safety and efficacy', 'safety and tolerability', 'number of PCR-confirmed infected pregnant women assessed from collected nasopharyngeal and oropharyngeal swabs']","[{'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0033052', 'cui_str': 'Antenatal care'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C1456498', 'cui_str': 'Attended'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0332299', 'cui_str': 'Suggestive of'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0436343', 'cui_str': 'Symptom mild'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}]","[{'cui': 'C0008783', 'cui_str': 'Cimetidine'}, {'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0012265', 'cui_str': 'Digoxin'}, {'cui': 'C0010592', 'cui_str': 'Cyclosporine'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0011008', 'cui_str': 'Date'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}]","[{'cui': 'C0436343', 'cui_str': 'Symptom mild'}, {'cui': 'C0332299', 'cui_str': 'Suggestive of'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0013404', 'cui_str': 'Dyspnea'}, {'cui': 'C0085593', 'cui_str': 'Chill'}, {'cui': 'C0221150', 'cui_str': 'Swallowing painful'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0231528', 'cui_str': 'Muscle pain'}, {'cui': 'C0003126', 'cui_str': 'Loss of sense of smell'}, {'cui': 'C0013378', 'cui_str': 'Taste sense altered'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0032520', 'cui_str': 'Polymerase chain reaction'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C3536619', 'cui_str': 'Nasopharyngeal and oropharyngeal swab'}]",,0.422207,To assess the efficacy of HCQ to prevent SARS-CoV-2 infection in pregnant women in contact with an infected or suspected case.,"[{'ForeName': 'Raquel', 'Initials': 'R', 'LastName': 'González', 'Affiliation': 'ISGlobal, Hospital Clínic-Universitat de Barcelona, Barcelona, Spain. raquel.gonzalez@isglobal.org.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'García-Otero', 'Affiliation': 'ISGlobal, Hospital Clínic-Universitat de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Clara', 'Initials': 'C', 'LastName': 'Pons-Duran', 'Affiliation': 'ISGlobal, Hospital Clínic-Universitat de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Marbán-Castro', 'Affiliation': 'ISGlobal, Hospital Clínic-Universitat de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Goncé', 'Affiliation': 'BCNATAL | Barcelona Center for Maternal Fetal and Neonatal Medicine, Hospital Clínic de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Elisa', 'Initials': 'E', 'LastName': 'Llurba', 'Affiliation': 'Obstetrics and Gynecology Department, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Del Mar Gil', 'Affiliation': 'Obstetrics and Gynecology Department, Hospital Universitario de Torrejón, Torrejón de Ardoz, Madrid, Spain.'}, {'ForeName': 'Miguel Ángel', 'Initials': 'MÁ', 'LastName': 'Rodríguez-Zambrano', 'Affiliation': 'HM Puerta del Sur, Móstoles, Madrid, Spain.'}, {'ForeName': 'Haily', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': 'ISGlobal, Hospital Clínic-Universitat de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Máximo', 'Initials': 'M', 'LastName': 'Ramírez', 'Affiliation': 'ISGlobal, Hospital Clínic-Universitat de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Azucena', 'Initials': 'A', 'LastName': 'Bardají', 'Affiliation': 'ISGlobal, Hospital Clínic-Universitat de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Clara', 'Initials': 'C', 'LastName': 'Menendez', 'Affiliation': 'ISGlobal, Hospital Clínic-Universitat de Barcelona, Barcelona, Spain.'}]",Trials,['10.1186/s13063-020-04557-y'] 2881,32616067,ChemoPROphyLaxIs with hydroxychloroquine For covId-19 infeCtious disease (PROLIFIC) to prevent covid-19 infection in frontline healthcare workers: A structured summary of a study protocol for a randomised controlled trial.,"OBJECTIVES PRIMARY OBJECTIVE: To determine whether chemoprophylaxis with hydroxychloroquine versus placebo increases time to contracting coronavirus disease 2019 (COVID-19) in frontline healthcare workers. SECONDARY OBJECTIVES 1) To determine whether chemoprophylaxis with daily versus weekly dosing of hydroxychloroquine increases time to contracting COVID-19 disease in frontline healthcare workers. 2) To compare the number of COVID-19 cases between each trial arm on the basis of positive tests (as per current clinical testing methods and/or serology) 3) To compare the percentage of COVID-19 positive individuals with current testing methods versus serologically-proven COVID-19 in each trial arm 4) To compare COVID-19 disease severity in each trial arm 5) To compare recovery time from COVID-19 infection in each trial arm EXPLORATORY OBJECTIVES: 1) To determine compliance (as measured by trough pharmacokinetic hydroxychloroquine levels) on COVID-19 positive tests 2) To determine if genetic factors determine susceptibility to COVID-19 disease or response to treatment 3) To determine if blood group determines susceptibility to COVID-19 disease 4) To compare serum biomarkers of COVID-19 disease in each arm TRIAL DESIGN: Double-blind, multi-centre, 2-arm (3:3:2 ratio) randomised placebo-controlled trial PARTICIPANTS: National Health Service (NHS) workers who have direct patient contact delivering care to patients with COVID-19. Participants in the trial will be recruited from a number of NHS hospitals directly caring for patients with COVID-19. INCLUSION CRITERIA To be included in the trial the participant MUST: 1) Have given written informed consent to participate 2) Be aged 18 years to 70 years 3) Not previously have been diagnosed with COVID-19 4) Work in a high-risk secondary or tertiary healthcare setting (hospitals accepting COVID-19 patients) with direct patient-facing care EXCLUSION CRITERIA: The presence of any of the following will mean participants are ineligible: 1) Known COVID-19 positive test at baseline (if available) 2) Symptomatic for possible COVID-19 at baseline 3) Known hypersensitivity reaction to hydroxychloroquine, chloroquine or 4-aminoquinolines 4) Known retinal disease 5) Known porphyria 6) Known chronic kidney disease (CKD; eGFR<30ml/min) 7) Known epilepsy 8) Known heart failure or conduction problems 9) Known significant liver disease (Gilbert's syndrome is permitted) 10) Known glucose-6-phosphate dehydrogenase (G6PD) deficiency 11) Currently taking any of the following contraindicated medications: Digoxin, Chloroquine, Halofantrine, Amiodarone, Moxifloxacin, Cyclosporin, Mefloquine, Praziquantel, Ciprofloxacin, Clarithromycin, Prochlorperazine, Fluconazole 12) Currently taking hydroxychloroquine or having a clinical indication for taking hydroxychloroquine 13) Currently breastfeeding 14) Unable to be followed-up during the trial 15) Current or future involvement in the active treatment phase of other interventional research studies (excluding observational/non-interventional studies) before study follow-up visit 16) Not able to use or have access to a modern phone device/web-based technology 17) Any other clinical reason which may preclude entry in the opinion of the investigator INTERVENTION AND COMPARATOR: Interventions being evaluated are: A) Daily hydroxychloroquine or B) Weekly hydroxychloroquine or C) Placebo The maximum treatment period is approximately 13 weeks per participant. Hydroxychloroquine-identical matched placebo tablets will ensure that all participants are taking the same number and dosing regimen of tablets across the three trial arms. There is no variation in the dose of hydroxychloroquine by weight. The dosing regimen for the three arms of the study (A, B, C) are described in further detail below. Arm A: Active Hydroxychloroquine (- daily dosing and placebo-matched hydroxychloroquine - weekly dosing). Form: Tablets Route: Oral. Dose and Frequency: Active hydroxychloroquine: Days 1-2: Loading phase - 400mg (2 x 200mg tablets) taken twice a day for 2 days Days 3 onwards: Maintenance Phase - 200mg (1 x 200mg tablet) taken once daily, every day for 90 days (~3 months) Matched Placebo hydroxychloroquine: Days 3 onwards: Maintenance Phase - 2 tablets taken once a week on the same day each week (every 7 th day) for 90 days (~3 months) Arm B: Active Hydroxychloroquine (- weekly dosing and placebo matched hydroxychloroquine - daily dosing.) Form: Tablets Route: Oral. Dose and Frequency: Active hydroxychloroquine: Days 1-2: Loading Phase - 400mg (2 x 200mg tablets) taken twice daily for 2 days Days 3 onwards: Maintenance Phase - 400mg (2 x 200mg tablets) taken once a week on the same day each week (every 7 th day) for 90 days (~3 months) Matched Placebo hydroxychloroquine: Days 3 onwards: Maintenance Phase - 1 tablet taken once daily for 90 days (~3 months) Arm C: Matched placebo Hydroxychloroquine (- daily dosing and matched placebo hydroxychloroquine - weekly dosing.) Form: Table. Route: Oral. Frequency: Matched placebo hydroxychloroquine - daily dosing: Days 1-2: Loading Phase - 2 tablets taken twice daily for 2 days Days 3 onwards: Maintenance Phase - 1 tablet taken once daily for 90 days (~3 months) Matched placebo hydroxychloroquine - weekly dosing: Days 3 onwards: Maintenance Phase - 2 tablets taken once a week on the same day each week (every 7th day) for 90 days (~3 months) A schematic of the dosing schedule can be found in the full study protocol (Additional File 1). MAIN OUTCOMES Time to diagnosis of positive COVID-19 disease (defined by record of date of symptoms onset and confirmed by laboratory test) RANDOMISATION: Participants will be randomised to either hydroxychloroquine dosed daily with weekly placebo, HCQ dosed weekly with daily placebo, or placebo dosed daily and weekly. Randomisation will be in a 3:3:2 ratio [hydroxychloroquine-(daily), hydroxychloroquine-(weekly), placebo], using stratified block randomisation. Random block sizes will be used, and stratification will be by study site. BLINDING (MASKING) Participants and trial investigators consenting participants, delivering trial assessments and procedures will be blinded to intervention. NUMBERS TO BE RANDOMISED (SAMPLE SIZE) A sufficient number of participants will be enrolled so that approximately 1000 participants in total will have data suitable for the primary statistical analysis. It is anticipated that approximately 1,200 participants will need to be enrolled in total, to allow for a 20% dropout over the period of the trial. This would result in approximately 450:450:300 participants randomised to hydroxychloroquine daily, hydroxychloroquine weekly+daily matched placebo or matched-placebo daily and weekly. TRIAL STATUS V 1.0, 7 th April 2020 EU Clinical Trials Register EudraCT Number: 2020-001331-26 Date of registration: 14 th April 2020 Trial registered before first participant enrolment. Trial site is Cambridge University Hospitals NHS Foundation Trust. Recruitment started on 11 th May 2020. It is anticipated that the trial will run for 12 months. The recruitment end date cannot yet be accurately predicted. FULL PROTOCOL The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest of expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol. The study protocol has been reported in accordance with the Standard Protocol Items: Recommendations for Clinical Interventional Trials (SPIRIT) guidelines (Additional file 2).",2020,There is no variation in the dose of hydroxychloroquine by weight.,"['V 1.0, 7 th April 2020', '10', 'Be aged 18 years to 70 years 3) Not previously have been diagnosed with COVID-19 4) Work in a high-risk secondary or tertiary healthcare setting (hospitals accepting COVID-19 patients) with direct patient-facing care EXCLUSION CRITERIA', ""or 4-aminoquinolines 4) Known retinal disease 5) Known porphyria 6) Known chronic kidney disease (CKD; eGFR<30ml/min) 7) Known epilepsy 8) Known heart failure or conduction problems 9) Known significant liver disease (Gilbert's syndrome is permitted"", 'Frequency', ' 2020-001331-26 Date of registration', '14 th April 2020', 'approximately 1,200 participants will need to be enrolled in total', 'National Health Service (NHS) workers who have direct patient contact delivering care to patients with COVID-19', 'frontline healthcare workers', 'Participants in the trial will be recruited from a number of NHS hospitals directly caring for patients with COVID-19', 'COVID-19 positive tests 2', '1']","['placebo Hydroxychloroquine (- daily dosing and matched placebo hydroxychloroquine - weekly dosing', 'Placebo', 'Active hydroxychloroquine', 'hydroxychloroquine', 'Weekly hydroxychloroquine or C', 'Active Hydroxychloroquine (- daily dosing and placebo-matched hydroxychloroquine', 'Hydroxychloroquine', 'hydroxychloroquine 13', 'Hydroxychloroquine-identical matched placebo tablets', 'placebo hydroxychloroquine', 'placebo, HCQ dosed weekly with daily placebo, or placebo', 'placebo hydroxychloroquine - daily dosing', 'hydroxychloroquine daily, hydroxychloroquine weekly+daily matched placebo or matched-placebo', 'Placebo hydroxychloroquine', 'Digoxin, Chloroquine, Halofantrine, Amiodarone, Moxifloxacin, Cyclosporin, Mefloquine, Praziquantel, Ciprofloxacin, Clarithromycin, Prochlorperazine, Fluconazole 12', 'hydroxychloroquine or B', 'hydroxychloroquine, chloroquine', 'placebo']","['Dose and Frequency', 'Time to diagnosis of positive COVID-19 disease (defined by record of date of symptoms onset and confirmed by laboratory test']","[{'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0557351', 'cui_str': 'Employed'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C3494403', 'cui_str': 'Tertiary Care'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C1272684', 'cui_str': 'Accepted'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439851', 'cui_str': 'Direct'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0048060', 'cui_str': '4-aminoquinoline'}, {'cui': 'C0205309', 'cui_str': 'Known'}, {'cui': 'C0035309', 'cui_str': 'Retinal disorder'}, {'cui': 'C0032708', 'cui_str': 'Disorder of porphyrin metabolism'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0014544', 'cui_str': 'Epilepsy'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0232217', 'cui_str': 'Cardiac conduction'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0023895', 'cui_str': 'Disease of liver'}, {'cui': 'C0017551', 'cui_str': ""Gilbert's syndrome""}, {'cui': 'C0023636', 'cui_str': 'Licenses'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0011008', 'cui_str': 'Date'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0027462', 'cui_str': 'National Health Services'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0332158', 'cui_str': 'Contact with'}, {'cui': 'C0018724', 'cui_str': 'Health Care Providers'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0796085', 'cui_str': 'Nance-Horan syndrome'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0336766', 'cui_str': 'Matches'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0205280', 'cui_str': 'Identical'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0012265', 'cui_str': 'Digoxin'}, {'cui': 'C0008269', 'cui_str': 'Chloroquine'}, {'cui': 'C0120726', 'cui_str': 'halofantrine'}, {'cui': 'C0002598', 'cui_str': 'Amiodarone'}, {'cui': 'C0536495', 'cui_str': 'moxifloxacin'}, {'cui': 'C0010592', 'cui_str': 'Cyclosporine'}, {'cui': 'C0025153', 'cui_str': 'Mefloquine'}, {'cui': 'C0032911', 'cui_str': 'Praziquantel'}, {'cui': 'C0008809', 'cui_str': 'Ciprofloxacin'}, {'cui': 'C0055856', 'cui_str': 'Clarithromycin'}, {'cui': 'C0033229', 'cui_str': 'Prochlorperazine'}, {'cui': 'C0016277', 'cui_str': 'Fluconazole'}]","[{'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C2355580', 'cui_str': 'Record of'}, {'cui': 'C0011008', 'cui_str': 'Date'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0022885', 'cui_str': 'Laboratory procedure'}]",1200.0,0.731188,There is no variation in the dose of hydroxychloroquine by weight.,"[{'ForeName': 'Carmel M', 'Initials': 'CM', 'LastName': 'McEniery', 'Affiliation': 'Division of Experimental Medicine & Immunotherapeutics, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Fisk', 'Affiliation': 'Division of Experimental Medicine & Immunotherapeutics, University of Cambridge, Cambridge, UK. mf503@medschl.cam.ac.uk.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Miles', 'Affiliation': 'Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK.'}, {'ForeName': 'Fotini', 'Initials': 'F', 'LastName': 'Kaloyirou', 'Affiliation': 'Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK.'}, {'ForeName': 'Evangelia', 'Initials': 'E', 'LastName': 'Vamvaka', 'Affiliation': 'Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK.'}, {'ForeName': 'Annette', 'Initials': 'A', 'LastName': 'Hubsch', 'Affiliation': 'Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Smith', 'Affiliation': 'Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK.'}, {'ForeName': 'Ian B', 'Initials': 'IB', 'LastName': 'Wilkinson', 'Affiliation': 'Division of Experimental Medicine & Immunotherapeutics, University of Cambridge, Cambridge, UK.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Cheriyan', 'Affiliation': 'Division of Experimental Medicine & Immunotherapeutics, University of Cambridge, Cambridge, UK.'}]",Trials,['10.1186/s13063-020-04543-4'] 2882,32620260,Effects of anaesthesia method and tourniquet use on recovery following total knee arthroplasty: a randomised controlled study.,"BACKGROUND We investigated the effects of spinal and general anaesthesia and surgical tourniquet on acute pain and early recovery after total knee arthroplasty (TKA). METHODS Patients (n=413) were randomised to four parallel groups: spinal anaesthesia with or without tourniquet, and general anaesthesia with or without tourniquet. The primary outcome was patient-controlled i.v. oxycodone consumption over 24 postoperative hours. RESULTS Results from 395 subjects were analysed. Median i.v. oxycodone consumption did not differ between the four groups (spinal anaesthesia without [36.6 mg] and with tourniquet [38.0 mg], general anaesthesia without [42.3 mg] and with tourniquet [42.5 mg], P=0.42), between spinal (37.7 mg) and general anaesthesia (42.5 mg) groups (median difference -3.1, 95% confidence interval [CI] -7.4 to 1.2, P=0.15) and between tourniquet and no-tourniquet groups (40.0 vs 40.0 mg, median difference -0.8, CI -5.1 to 3.5, P=0.72). Vomiting incidence was higher with spinal than with general anaesthesia (21% [42/200] vs 13% [25/194], CI 1.05 to 3.1, P=0.034). The mean haemoglobin decrease was greater without than with tourniquet (-3.0 vs -2.5 g dl -1 , mean difference -0.48, CI -0.65 to -0.32, P<0.001). No differences were observed in pain, pain management, incidences of blood transfusions, in-hospital complications, or length of hospital stay. CONCLUSIONS For TKA, spinal and general anaesthesia with or without tourniquet did not differ in 24-h postoperative opioid consumption, pain management, blood transfusions, in-hospital complications, and length of hospital stay. Vomiting incidence was higher in the spinal than in the general anaesthesia group. Tourniquet use caused smaller decreases in haemoglobin levels. CLINICAL TRIAL REGISTRATION EudraCT 2016-002035-15.",2020,"No differences were observed in pain, pain management, incidences of blood transfusions, in-hospital complications, or length of hospital stay. ","['395 subjects were analysed', 'total knee arthroplasty', 'Patients (n=413', 'after total knee arthroplasty (TKA']","['anaesthesia method and tourniquet', 'spinal anaesthesia with or without tourniquet, and general anaesthesia with or without tourniquet', 'spinal and general anaesthesia and surgical tourniquet', 'EudraCT', 'oxycodone']","['acute pain and early recovery', 'mean haemoglobin decrease', 'pain, pain management, incidences of blood transfusions, in-hospital complications, or length of hospital stay', 'haemoglobin levels', 'Vomiting incidence', '24-h postoperative opioid consumption, pain management, blood transfusions, in-hospital complications, and length of hospital stay', 'consumption']","[{'cui': 'C0086511', 'cui_str': 'Total knee replacement'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0040519', 'cui_str': 'Tourniquet'}, {'cui': 'C0002928', 'cui_str': 'Spinal anesthesia'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0030049', 'cui_str': 'Oxycodone'}]","[{'cui': 'C0184567', 'cui_str': 'Acute pain'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0162119', 'cui_str': 'Hemoglobin low'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}]",395.0,0.127039,"No differences were observed in pain, pain management, incidences of blood transfusions, in-hospital complications, or length of hospital stay. ","[{'ForeName': 'Riku', 'Initials': 'R', 'LastName': 'Palanne', 'Affiliation': 'Department of Anaesthesiology, Intensive Care and Pain Medicine, Peijas Hospital, HUS Helsinki University Hospital, Helsinki, Finland; Department of Anaesthesiology and Intensive Care, Central Finland Central Hospital, Jyväskylä, Finland.'}, {'ForeName': 'Mikko', 'Initials': 'M', 'LastName': 'Rantasalo', 'Affiliation': 'Department of Orthopaedics and Traumatology, Arthroplasty Center, Peijas Hospital, HUS Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Vakkuri', 'Affiliation': 'Department of Anaesthesiology, Intensive Care and Pain Medicine, Peijas Hospital, HUS Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Rami', 'Initials': 'R', 'LastName': 'Madanat', 'Affiliation': 'Department of Orthopaedics and Traumatology, Arthroplasty Center, Peijas Hospital, HUS Helsinki University Hospital, Helsinki, Finland; Terveystalo Kamppi, Helsinki, Finland.'}, {'ForeName': 'Klaus T', 'Initials': 'KT', 'LastName': 'Olkkola', 'Affiliation': 'Department of Anaesthesiology, Intensive Care and Pain Medicine, University of Helsinki and HUS Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Katarina', 'Initials': 'K', 'LastName': 'Lahtinen', 'Affiliation': 'Department of Anaesthesiology, Intensive Care and Pain Medicine, Peijas Hospital, HUS Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Elina', 'Initials': 'E', 'LastName': 'Reponen', 'Affiliation': 'Department of Anaesthesiology, Intensive Care and Pain Medicine, Peijas Hospital, HUS Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Rita', 'Initials': 'R', 'LastName': 'Linko', 'Affiliation': 'Department of Anaesthesiology, Intensive Care and Pain Medicine, Peijas Hospital, HUS Helsinki University Hospital, Helsinki, Finland.'}, {'ForeName': 'Tero', 'Initials': 'T', 'LastName': 'Vahlberg', 'Affiliation': 'Department of Clinical Medicine, Biostatistics, University of Turku and Turku University Hospital, Turku, Finland.'}, {'ForeName': 'Noora', 'Initials': 'N', 'LastName': 'Skants', 'Affiliation': 'Department of Anaesthesiology, Intensive Care and Pain Medicine, Peijas Hospital, HUS Helsinki University Hospital, Helsinki, Finland. Electronic address: noora.skants@hus.fi.'}]",British journal of anaesthesia,['10.1016/j.bja.2020.03.036'] 2883,32620262,High-dose versus low-dose tranexamic acid for paediatric craniosynostosis surgery: a double-blind randomised controlled non-inferiority trial.,"BACKGROUND Tranexamic acid (TXA) reduces blood loss and transfusion in paediatric craniosynostosis surgery. The hypothesis is that low-dose TXA, determined by pharmacokinetic modelling, is non-inferior to high-dose TXA in decreasing blood loss and transfusion in children. METHODS Children undergoing craniosynostosis surgery were enrolled in a two-centre, prospective, double-blind, randomised, non-inferiority controlled trial to receive high TXA (50 mg kg -1 followed by 5 mg kg -1 h -1 ) or low TXA (10 mg kg -1 followed by 5 mg kg -1 h -1 ). Primary outcome was blood loss. Low dose was determined to be non-inferior to high dose if the 95% confidence interval (CI) for the mean difference in blood loss was above the non-inferiority margin of -20 ml kg -1 . Secondary outcomes were transfusion, TXA plasma concentrations, and biological markers of fibrinolysis and inflammation. RESULTS Sixty-eight children were included. Values were non-inferior regarding blood loss (39.4 [4.4] vs 40.3 [6.2] ml kg -1 [difference=0.9; 95% CI: -14.2, 15.9]) and blood transfusion (21.3 [1.6] vs 23.6 [1.5] ml kg -1 [difference=2.3; 95% CI: -2.1, 6.7]) between high-dose (n=32) and low-dose (n=34) groups, respectively. The TXA plasma concentrations during surgery averaged 50.2 (8.0) and 29.6 (7.6) μg ml -1 . There was no difference in fibrinolytic and inflammatory biological marker concentrations. No adverse events were observed. CONCLUSIONS Tranexamic acid 10 mg kg -1 followed by 5 mg kg -1 h -1 is not less effective than a higher dose of 50 mg kg -1 and 5 mg kg -1 h -1 in reducing blood loss and transfusion in paediatric craniosynostosis surgery. CLINICAL TRIAL REGISTRATION NCT02188576.",2020,"No adverse events were observed. ","['paediatric craniosynostosis surgery', 'Sixty-eight children were included', 'Children undergoing craniosynostosis surgery']","['TXA', 'High-dose versus low-dose tranexamic acid', 'Tranexamic acid (TXA', 'low TXA', 'Tranexamic acid']","['TXA plasma concentrations', 'fibrinolytic and inflammatory biological marker concentrations', 'adverse events', 'transfusion, TXA plasma concentrations, and biological markers of fibrinolysis and inflammation', 'blood transfusion', 'blood loss']","[{'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0010278', 'cui_str': 'Craniosynostosis syndrome'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0450387', 'cui_str': '68'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0445550', 'cui_str': 'Low dose'}, {'cui': 'C0205251', 'cui_str': 'Low'}]","[{'cui': 'C0040613', 'cui_str': 'Tranexamic Acid'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0040044', 'cui_str': 'Thrombolytic therapy'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0005841', 'cui_str': 'Transfusion of blood product'}, {'cui': 'C0016017', 'cui_str': 'Fibrinolysis'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}]",68.0,0.800882,"No adverse events were observed. ","[{'ForeName': 'Susan M', 'Initials': 'SM', 'LastName': 'Goobie', 'Affiliation': ""Department of Anesthesiology, Critical Care and Pain Medicine, Boston Children's Hospital, Harvard Medical School, Boston, MA, USA. Electronic address: susan.goobie@childrens.harvard.edu.""}, {'ForeName': 'Steven J', 'Initials': 'SJ', 'LastName': 'Staffa', 'Affiliation': ""Department of Anesthesiology, Critical Care and Pain Medicine, Boston Children's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'John G', 'Initials': 'JG', 'LastName': 'Meara', 'Affiliation': ""Department of Plastic and Oral Surgery, Boston Children's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Mark R', 'Initials': 'MR', 'LastName': 'Proctor', 'Affiliation': ""Department of Neurosurgery, Boston Children's Hospital, Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Miriam', 'Initials': 'M', 'LastName': 'Tumolo', 'Affiliation': 'Department of Anaesthesia, IRCCS Istituto Giannina Gaslini, Genoa, Italy.'}, {'ForeName': 'Giuliana', 'Initials': 'G', 'LastName': 'Cangemi', 'Affiliation': 'Central Laboratory of Analyses, IRCCS Istituto Giannina Gaslini, Genoa, Italy.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Disma', 'Affiliation': 'Department of Anaesthesia, IRCCS Istituto Giannina Gaslini, Genoa, Italy.'}]",British journal of anaesthesia,['10.1016/j.bja.2020.05.054'] 2884,32620300,Free flap donor site during early review consultations: is it really an issue?,"Donor site complications, following microvascular free tissue transfer, can limit recovery in patients treated for head and neck cancer, with a curative intent. The Patient Concerns Inventory (PCI-HN) is a prompt list that provides patients with repeated opportunities to raise issues they feel are important and want to discuss. Here, we look at baseline results from a cluster preference randomised control trial with consultants either ""using"" or ""not using"" the PCI package in clinic to identify patient concerns. UWQOL results were presented from 67 consecutive patients having reconstruction with free tissue transfer and PCI results from 25 of these patients in the PCI arm of the trial. During early review consultations patients most wanted to discuss issues related to dental health, dry mouth, and chewing. Donor site morbidity, in our patient sample, did not appear to be an issue that patients wanted to discuss.",2020,"Donor site complications, following microvascular free tissue transfer, can limit recovery in patients treated for head and neck cancer, with a curative intent.","['patients treated for head and neck cancer, with a curative intent', '67 consecutive patients having reconstruction with free tissue transfer and PCI results from 25 of these patients in the PCI arm of the trial']","['using"" or ""not using"" the PCI package']",[],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for'}, {'cui': 'C0278996', 'cui_str': 'Malignant tumor of head and neck'}, {'cui': 'C1276305', 'cui_str': 'Curative - procedure intent'}, {'cui': 'C1283828', 'cui_str': 'Has intent'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0020912', 'cui_str': 'Image Reconstruction'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0040300', 'cui_str': 'Body tissue structure'}, {'cui': 'C0040671', 'cui_str': 'Transfer (Psychology)'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0445107', 'cui_str': 'Not used'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous coronary intervention'}, {'cui': 'C0013194', 'cui_str': 'Packaging, Drug'}]",[],67.0,0.072294,"Donor site complications, following microvascular free tissue transfer, can limit recovery in patients treated for head and neck cancer, with a curative intent.","[{'ForeName': 'A N', 'Initials': 'AN', 'LastName': 'Kanatas', 'Affiliation': 'Leeds Teaching Hospitals and St James Institute of Oncology and Leeds Dental Institute. Electronic address: a.kanatas@doctors.org.uk.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Lowe', 'Affiliation': 'Director Astraglobe Ltd, Congleton, Cheshire, UK. Electronic address: astraglobeltd@btconnect.com.'}, {'ForeName': 'S N', 'Initials': 'SN', 'LastName': 'Rogers', 'Affiliation': 'Evidence-Based Practice Research Centre (EPRC), Faculty of Health and Social Care, Edge Hill University, St Helens Road, Ormskirk, L39 4QP, UK; Consultant Regional Maxillofacial Unit, University Hospital Aintree, Liverpool, L9 1AE, UK. Electronic address: simonn.rogers@aintree.nhs.uk.'}]",The British journal of oral & maxillofacial surgery,['10.1016/j.bjoms.2020.06.007'] 2885,32617301,Comparative study of Pauwels type III femoral neck fractures managed by short dynamic hip screw with fibula bone graft or cannulated screws in young adults.,"Background The aim of our study was to compare the clinical effect of short dynamic hip screw (DHS) combined with fibula bone graft and short DHS combined with cannulated screws (CS) on the treatment of femoral neck fracture in young adults. Methods Thirty-five Pauwels type III femoral neck fracture patients between January 2014 and May 2019 were divided into two groups: group A (patients treated with DHS combined with fibula bone graft) and group B (patient treated with DHS combined with CS). The operative time, intraoperative blood loss, fracture healing time and complication of two groups were recorded. Results There were no significant differences in operative time, intraoperative blood loss in two groups. Fracture healing time in group A (5.28±1.07) was significantly shorter than group B (7.31±1.65). The rate of fracture nonunion (0), femoral head necrosis (0) and withdrawal rate (0) in group A were significantly lower than that in group B (4, 23.5) (4, 23.5) (6, 35.3) (P<0.01). Postoperative Harris function score in group A (95.44±2.57) was higher than group B (87.82±7.79) (P<0.01). Conclusions DHS combined with fibula bone graft can shorten the healing time of fracture, reduce the rate of bone nonunion and femoral head necrosis, and provide a new treatment method for Pauwels type III femoral neck fracture in young adults.",2020,"There were no significant differences in operative time, intraoperative blood loss in two groups.","['young adults', 'femoral neck fracture patients between January 2014 and May 2019', 'Methods\n\n\nThirty-five Pauwels type III', 'femoral neck fracture in young adults', 'Pauwels type III femoral neck fracture in young adults']","['DHS combined with fibula bone graft', 'Pauwels type III femoral neck fractures managed by short dynamic hip screw with fibula bone graft or cannulated screws', 'short dynamic hip screw (DHS) combined with fibula bone graft and short DHS combined with cannulated screws (CS', 'DHS combined with fibula bone graft) and group B (patient treated with DHS combined with CS']","['healing time of fracture', 'rate of fracture nonunion (0), femoral head necrosis (0) and withdrawal rate (0', 'operative time, intraoperative blood loss, fracture healing time and complication', 'operative time, intraoperative blood loss', 'Postoperative Harris function score', 'Fracture healing time']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0015806', 'cui_str': 'Fracture of neck of femur'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4319605', 'cui_str': '35'}, {'cui': 'C0441731', 'cui_str': 'Type 3'}]","[{'cui': 'C0729333', 'cui_str': 'Dynamic'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0005975', 'cui_str': 'Bone screw'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0016068', 'cui_str': 'Bone structure of fibula'}, {'cui': 'C0181074', 'cui_str': 'Graft material'}, {'cui': 'C0441731', 'cui_str': 'Type 3'}, {'cui': 'C0015806', 'cui_str': 'Fracture of neck of femur'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0348801', 'cui_str': 'Group B streptococcal pneumonia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}]","[{'cui': 'C0043240', 'cui_str': 'Tissue repair'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0016658', 'cui_str': 'Fracture'}, {'cui': 'C0016665', 'cui_str': 'Fracture, ununited'}, {'cui': 'C0015813', 'cui_str': 'Structure of head of femur'}, {'cui': 'C0027540', 'cui_str': 'Necrosis'}, {'cui': 'C0152128', 'cui_str': 'Drug withdrawal'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0152231', 'cui_str': 'Fracture, healed'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0449820', 'cui_str': 'Score'}]",,0.0185278,"There were no significant differences in operative time, intraoperative blood loss in two groups.","[{'ForeName': 'Zhengqiang', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Trauma Emergency Center, Third Hospital of Hebei Medical University, Shijiazhuang, China.'}, {'ForeName': 'Xuebin', 'Initials': 'X', 'LastName': 'Zhang', 'Affiliation': 'Trauma Emergency Center, Third Hospital of Hebei Medical University, Shijiazhuang, China.'}, {'ForeName': 'Zhaowei', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'Trauma Orthopedics, Affiliated Hospital of Qinghai University, Xining, China.'}, {'ForeName': 'Aqin', 'Initials': 'A', 'LastName': 'Peng', 'Affiliation': 'Trauma Emergency Center, Third Hospital of Hebei Medical University, Shijiazhuang, China.'}, {'ForeName': 'Lichuang', 'Initials': 'L', 'LastName': 'Zhang', 'Affiliation': 'Trauma Emergency Center, Third Hospital of Hebei Medical University, Shijiazhuang, China.'}, {'ForeName': 'Yingying', 'Initials': 'Y', 'LastName': 'Deng', 'Affiliation': 'Trauma Emergency Center, Third Hospital of Hebei Medical University, Shijiazhuang, China.'}, {'ForeName': 'Lianxin', 'Initials': 'L', 'LastName': 'Song', 'Affiliation': 'Trauma Emergency Center, Third Hospital of Hebei Medical University, Shijiazhuang, China.'}]",Annals of translational medicine,['10.21037/atm-19-3344'] 2886,32617320,Artificial intelligence-tutoring problem-based learning in ophthalmology clerkship.,"Background Artificial intelligence (AI) is an increasingly popular tool in medical investigations. However, AI's potential of aiding medical teaching has not been explored. This study aimed to evaluate the effectiveness of AI-tutoring problem-based-learning (PBL) in ophthalmology clerkship and to assess the student evaluations of this module. Methods Thirty-eight Grade-two students in ophthalmology clerkship at Sun Yat-Sen University were randomly assigned to two groups. In Group A, students learned congenital cataracts through an AI-tutoring PBL module by exploring and operating an AI diagnosis platform. In Group B, students learned congenital cataracts through traditional lecture given with the same faculty. The improvement in student performance was evaluated by comparing the pre- and post-lecture scores of a specific designed test using paired-T tests. Student evaluations of AI-tutoring PBL were measured by a 17-item questionnaire. Results The post-lecture scores were significantly higher than the pre-lecture scores in both groups (Group A: P<0.0001, Group B: P<0.0001). The improvement of group A in the part of sign and diagnosis test (Part I) was more significant than that of group B (P=0.016). However, there was no difference in the improvement in the part of treatment plan test (Part II) between two groups (P=0.556). Overall, all respondents were satisfied and agreed that AI-tutoring PBL was helpful, effective, motive and beneficial to help develop critical and creative thinking. Conclusions The application of AI-tutoring PBL into ophthalmology clerkship improved students' performance and satisfaction. AI-tutoring PBL teaching showed advantage in promoting students' understanding of signs of diseases. The instructors play an indispensable role in AI-tutoring PBL curriculum.",2020,"However, there was no difference in the improvement in the part of treatment plan test (Part II) between two groups (P=0.556).","['ophthalmology clerkship', 'Methods\n\n\nThirty-eight Grade-two students in ophthalmology clerkship at Sun Yat-Sen University']","['Artificial intelligence-tutoring problem-based learning', '\n\n\nArtificial intelligence (AI', 'AI-tutoring problem-based-learning (PBL']","[""students' performance and satisfaction"", 'Student evaluations of AI-tutoring PBL', 'student performance']","[{'cui': 'C0029087', 'cui_str': 'Ophthalmology'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0450361', 'cui_str': '38'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0038817', 'cui_str': 'Sunlight'}, {'cui': 'C0036644', 'cui_str': 'Senegal'}, {'cui': 'C0041740', 'cui_str': 'University'}]","[{'cui': 'C0003916', 'cui_str': 'Computer Reasoning'}, {'cui': 'C0243013', 'cui_str': 'Problem-Based Learning'}]","[{'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0003916', 'cui_str': 'Computer Reasoning'}, {'cui': 'C0243013', 'cui_str': 'Problem-Based Learning'}]",38.0,0.0233503,"However, there was no difference in the improvement in the part of treatment plan test (Part II) between two groups (P=0.556).","[{'ForeName': 'Dongxuan', 'Initials': 'D', 'LastName': 'Wu', 'Affiliation': 'State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Yifan', 'Initials': 'Y', 'LastName': 'Xiang', 'Affiliation': 'State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Xiaohang', 'Initials': 'X', 'LastName': 'Wu', 'Affiliation': 'State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Tongyong', 'Initials': 'T', 'LastName': 'Yu', 'Affiliation': 'State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Xiucheng', 'Initials': 'X', 'LastName': 'Huang', 'Affiliation': 'State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Yuxian', 'Initials': 'Y', 'LastName': 'Zou', 'Affiliation': 'State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Zhenzhen', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Haotian', 'Initials': 'H', 'LastName': 'Lin', 'Affiliation': 'State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangzhou, China.'}]",Annals of translational medicine,['10.21037/atm.2019.12.15'] 2887,32617376,"Health-Related Quality of Life as Measured by the 12-Item Short-Form Survey Among Adults With Community-Acquired Bacterial Pneumonia who Received Either Lefamulin or Moxifloxacin in 2 Phase III Randomized, Double-Blind, Double-Dummy Clinical Trials.","Background Interest in patient-reported outcomes (PROs) as part of benefit-risk assessment for new drug approvals is increasing. Lefamulin is the first intravenous (IV) and oral pleuromutilin antibiotic for treatment of adults with community-acquired bacterial pneumonia (CABP). Assessment of health-related quality of life (HRQoL) was prospectively incorporated in its CABP trials (Lefamulin Evaluation Against Pneumonia [LEAP] 1 and 2) via the 12-Item Short-Form Survey (SF-12), a widely used PRO that measures general health status in 8 domains. Methods HRQoL was evaluated by SF-12 at baseline and test of cure (TOC; 5-10 days after the last study drug dose) in patients who received lefamulin or moxifloxacin in LEAP 1 (IV/oral treatment) and LEAP 2 (oral-only treatment). SF-12 outcomes included the 8 domains, physical component and mental component summary scores, and the Short-Form Six-Dimension health utility score. Results Analysis included 1215 patients (lefamulin: n = 607; moxifloxacin: n = 608). At baseline, all mean SF-12 scores in both treatment groups were well below the United States reference mean. Clinically meaningful and significant improvements from baseline to TOC were observed in all SF-12 scores. No significant differences in mean score improvements from baseline to TOC between treatment groups were observed. SF-12 score improvements at TOC across predefined subgroups were comparable between treatment groups. Conclusions Results indicate that adults with CABP experienced comparable HRQoL improvements with lefamulin relative to moxifloxacin, and treatment with either agent resulted in returns to population norm HRQoL levels. These data suggest that lefamulin is a potential alternative to moxifloxacin for treatment of adults with CABP.",2020,No significant differences in mean score improvements from baseline to TOC between treatment groups were observed.,"['1215 patients (lefamulin: n = 607', 'adults with community-acquired bacterial pneumonia (CABP', 'adults with CABP', 'Adults With Community-Acquired Bacterial Pneumonia who Received Either']","['oral pleuromutilin antibiotic', 'moxifloxacin', 'Lefamulin or Moxifloxacin', 'lefamulin or moxifloxacin']","['health-related quality of life (HRQoL', 'SF-12 score improvements', 'mean score improvements', 'Health-Related Quality of Life', '8 domains, physical component and mental component summary scores, and the Short-Form Six-Dimension health utility score', 'mean SF-12 scores']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0456394', 'cui_str': 'Community acquired'}, {'cui': 'C0004626', 'cui_str': 'Bacterial pneumonia'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0071283', 'cui_str': 'Pleuromutilin'}, {'cui': 'C0003232', 'cui_str': 'Antibiotic'}, {'cui': 'C0536495', 'cui_str': 'moxifloxacin'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0205431', 'cui_str': 'Formed'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}]",1215.0,0.0972764,No significant differences in mean score improvements from baseline to TOC between treatment groups were observed.,"[{'ForeName': 'Thomas P', 'Initials': 'TP', 'LastName': 'Lodise', 'Affiliation': 'Albany College of Pharmacy and Health Sciences, Albany, New York, USA.'}, {'ForeName': 'Sam', 'Initials': 'S', 'LastName': 'Colman', 'Affiliation': 'Covance Market Access Services Inc., Gaithersburg, Maryland, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Alexander', 'Affiliation': 'Nabriva Therapeutics US, Inc., King of Prussia, Pennsylvania, USA.'}, {'ForeName': 'Daniel S', 'Initials': 'DS', 'LastName': 'Stein', 'Affiliation': 'Nabriva Therapeutics US, Inc., King of Prussia, Pennsylvania, USA.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Fitts', 'Affiliation': 'Nabriva Therapeutics US, Inc., King of Prussia, Pennsylvania, USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Goldberg', 'Affiliation': 'Nabriva Therapeutics US, Inc., King of Prussia, Pennsylvania, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Schranz', 'Affiliation': 'Nabriva Therapeutics US, Inc., King of Prussia, Pennsylvania, USA.'}]",Open forum infectious diseases,['10.1093/ofid/ofaa209'] 2888,32617408,The anesthetic efficiency of retromolar infiltrations with two local anesthetic solutions of the same concentration in lower third molar surgery.,"Background Mandibular third molar removal is the most common surgical procedure encountered in oral and maxillofacial clinics. It also presents the greatest challenges and controversies for surgeons when surgical removal is considered. Furthermore, diverse anesthesia results and success rates are achieved after using the same concentrations of different solutions or the same amounts of local anesthetics. The purpose of this study was to examine the efficiency of using double-cartridge (3.4 ml) 4% lidocaine (high concentration) and 4% articaine with a 1:100000 epinephrine infiltration in the retromolar region for impacted lower third molar surgery. Methods This double-blind study included 30 patients with symmetrically impacted lower third molars. The patients were randomly selected to receive 4% articaine on one side and 4% lidocaine on the other, as a local anesthetic for third molar surgery. The onset, duration of soft-tissue numbness, pulpal sensitivity, amount of additional local anesthetic needed, pain score during the surgical procedure, and duration of the operation were recorded. Results The results of this research indicate that 86.7% of the operations in the 4% articaine group and 83.3% of those in the 4% lidocaine group were successful. Furthermore, the outcomes in both groups were not statistically significant (P > 0.05). Numbness onset occurred faster in the articaine group than it did in the lidocaine group. However, the duration of soft-tissue anesthesia and pain scores recorded immediately postoperatively were similar. Conclusion It is concluded that 4% lidocaine and 4% articaine had a similar infiltration efficacy in the retromolar region and both local anesthetics are adequate for impacted lower third molar surgery. There were no statistically significant differences between the two local anesthetics regarding pain control and the duration of soft-tissue numbness during the procedure.",2020,There were no statistically significant differences between the two local anesthetics regarding pain control and the duration of soft-tissue numbness during the procedure.,"['30 patients with symmetrically impacted lower third molars', 'lower third molar surgery', 'retromolar region for impacted lower third molar surgery']","['articaine', 'double-cartridge (3.4 ml) 4% lidocaine (high concentration) and 4% articaine', 'lidocaine', 'articaine on one side and 4% lidocaine']","['Numbness onset', 'pain control and the duration of soft-tissue numbness', 'infiltration efficacy', 'duration of soft-tissue anesthesia and pain scores', 'onset, duration of soft-tissue numbness, pulpal sensitivity, amount of additional local anesthetic needed, pain score during the surgical procedure, and duration of the operation']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0040456', 'cui_str': 'Impacted tooth'}, {'cui': 'C0227191', 'cui_str': 'Structure of lower third of esophagus'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}]","[{'cui': 'C1608295', 'cui_str': 'Articaine'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0179630', 'cui_str': 'Cartridge'}, {'cui': 'C4517692', 'cui_str': '3.4'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0205092', 'cui_str': 'Unilateral'}]","[{'cui': 'C0020580', 'cui_str': 'Hypesthesia'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0002766', 'cui_str': 'Pain management'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0225317', 'cui_str': 'Soft tissue'}, {'cui': 'C0332448', 'cui_str': 'Infiltration'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0002921', 'cui_str': 'Local anesthesia'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0543467', 'cui_str': 'Surgery'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]",30.0,0.10149,There were no statistically significant differences between the two local anesthetics regarding pain control and the duration of soft-tissue numbness during the procedure.,"[{'ForeName': 'Phouthala', 'Initials': 'P', 'LastName': 'Sayphiboun', 'Affiliation': 'Department of Oral & Maxillofacial Surgery, Faculty of Dentistry, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Kiatanant', 'Initials': 'K', 'LastName': 'Boonsiriseth', 'Affiliation': 'Department of Oral & Maxillofacial Surgery, Faculty of Dentistry, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Basel', 'Initials': 'B', 'LastName': 'Mahardawi', 'Affiliation': 'Department of Oral & Maxillofacial Surgery, Faculty of Dentistry, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Verasak', 'Initials': 'V', 'LastName': 'Pairuchvej', 'Affiliation': 'Department of Oral & Maxillofacial Surgery, Faculty of Dentistry, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Bishwa Prakash', 'Initials': 'BP', 'LastName': 'Bhattarai', 'Affiliation': 'Walailak University International College of Dentistry, Bangkok, Thailand.'}, {'ForeName': 'Natthamet', 'Initials': 'N', 'LastName': 'Wongsirichat', 'Affiliation': 'Department of Oral & Maxillofacial Surgery, Faculty of Dentistry, Mahidol University, Bangkok, Thailand.'}]",Journal of dental anesthesia and pain medicine,['10.17245/jdapm.2020.20.3.137'] 2889,32617409,Post-operative analgesia of 2% lignocaine with or without magnesium sulfate for inferior alveolar nerve block in symptomatic mandibular molars - a randomized double blind controlled clinical trial.,"Background Single inferior alveolar nerve block is ineffective in achieving adequate pulpal anesthesia in 30-80% of patients due to anatomical variations, local tissue pH, central sensitization, and several factors. Various supplementary techniques and combination of adjuvants with lignocaine are used to overcome these failures. Magnesium sulfate (MgSO 4 ), one such adjuvant, acts at the N-methyl-D-aspartate glutamate receptor resulting in effective anesthesia. The aim of this prospective, randomized, double-blind, clinical controlled trial was to evaluate the onset, anesthetic efficacy, duration and post-operative analgesia of 2% lignocaine with and without the addition of MgSO 4 in patients with symptomatic irreversible pulpitis and apical periodontitis. Methods Fourty-two patients were randomly divided into three groups: 2% lignocaine (group 1) and 2% lignocaine with MgSO 4 (75 mg) and (150 mg) in groups 2 and 3, respectively. Pre-operative vitals and Heft Parker-Visual Analogue Scale (HP-VAS) pain scores were recorded. The onset of anesthesia, anesthetic efficacy, and duration of anesthesia were evaluated post administration of the local anesthetic solution. The post-operative analgesia was examined at intervals of 2, 6, 12, 24, and 48 h. Results Administration of 150 mg MgSO 4 hastens the onset of anesthesia (1.29 min) and produces better anesthetic efficacy (3.29 HP-VAS) compared to group 2 (2.07 min and 9.14 HP-VAS) and group 1 (3.29 min and 35.79 HP-VAS), respectively. The duration of anesthesia was significantly higher in group 3 (247.07 min) compared to that of groups 2 and 1 (190 min and 110.21 min) with P < 0.05. Conclusion Combining 75 mg or 150 mg of MgSO 4 with lignocaine is more effective than 2% lignocaine and 75 mg of MgSO 4 is adequate for endodontic procedures.",2020,"The duration of anesthesia was significantly higher in group 3 (247.07 min) compared to that of groups 2 and 1 (190 min and 110.21 min) with P < 0.05. ","['patients with symptomatic irreversible pulpitis and apical periodontitis', 'Methods\n\n\nFourty-two patients', 'symptomatic mandibular molars ']","['Magnesium sulfate (MgSO 4 ', 'lignocaine', 'lignocaine with or without magnesium sulfate', 'lignocaine with MgSO 4']","['duration of anesthesia', 'anesthetic efficacy', 'onset of anesthesia, anesthetic efficacy, and duration of anesthesia', 'Pre-operative vitals and Heft Parker-Visual Analogue Scale (HP-VAS) pain scores', 'onset, anesthetic efficacy, duration and post-operative analgesia']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0031030', 'cui_str': 'Apical periodontitis'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0024687', 'cui_str': 'Bone structure of mandible'}, {'cui': 'C0026367', 'cui_str': 'Structure of molar tooth'}]","[{'cui': 'C0024480', 'cui_str': 'Magnesium Sulfate'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}]","[{'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0002930', 'cui_str': 'Anesthetics'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0332162', 'cui_str': 'Onset of'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0442732', 'cui_str': 'Vital'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0853389', 'cui_str': 'Postoperative analgesia'}]",,0.123803,"The duration of anesthesia was significantly higher in group 3 (247.07 min) compared to that of groups 2 and 1 (190 min and 110.21 min) with P < 0.05. ","[{'ForeName': 'Charanya', 'Initials': 'C', 'LastName': 'Chandrasekaran', 'Affiliation': 'Tagore Dental College and Hospital, Rathinamangalam, Chennai, India.'}, {'ForeName': 'Vijay', 'Initials': 'V', 'LastName': 'Amirtharaj L', 'Affiliation': 'SRM Dental College, Ramapuram, Chennai, India.'}, {'ForeName': 'Mahalaxmi', 'Initials': 'M', 'LastName': 'Sekar', 'Affiliation': 'SRM Dental College, Ramapuram, Chennai, India.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'Nancy S', 'Affiliation': 'SRM Dental College, Ramapuram, Chennai, India.'}]",Journal of dental anesthesia and pain medicine,['10.17245/jdapm.2020.20.3.147'] 2890,32617453,"Multistrain Probiotic Increases the Gut Microbiota Diversity in Obese Pregnant Women: Results from a Randomized, Double-Blind Placebo-Controlled Study.","Background Maternal obesity is associated with adverse pregnancy outcomes. Probiotic supplementation during pregnancy may have positive effects on blood glucose, gestational weight gain (GWG), and the risk of gestational diabetes mellitus [GDM and glycated hemoglobin (HbA1c)]. Objectives This feasibility study involved a daily probiotic intervention in obese pregnant women from the early second trimester until delivery. The primary aim was to investigate the effect on GWG and maternal glucose homeostasis (GDM and HbA1c). Secondary aims were the effect on infant birth weight, maternal gut microbiota, and other pregnancy outcomes. Methods We carried out a randomized double-blinded placebo-controlled study in 50 obese pregnant women. Participants were randomly allocated (1:1) to multistrain probiotic (4 capsules of Vivomixx ® ; total of 450 billion CFU/d) or placebo at 14-20 weeks of gestation until delivery. Participants were followed with 2 predelivery visits at gestational week 27-30 and 36-37 and with 1 postdelivery visit. All visits included blood and fecal sampling. An oral-glucose-tolerance test was performed at inclusion and gestational week 27-30. Results Forty-nine participants completed the study. Thirty-eight participants took >80% of the capsules ( n  = 21), placebo ( n  = 17). There was no significant difference in GWG, GDM, HbA1c concentrations, and infant birth weight between groups. Fecal microbiota analyses showed an overall increase in α-diversity over time in the probiotic group only ( P =  0.016). Conclusions Administration of probiotics during pregnancy is feasible in obese women and the women were willing to participate in additional study visits and collection of fecal samples during pregnancy. Multistrain probiotic can modulate the gut microbiota in obese women during pregnancy. A larger study population is needed to uncover pregnancy effects after probiotic supplementation. This trial was registered at clincaltrials.gov as NCT02508844.",2020,"There was no significant difference in GWG, GDM, HbA1c concentrations, and infant birth weight between groups.","['Participants were followed with 2 predelivery visits at gestational week 27-30 and 36-37 and with 1 postdelivery visit', 'obese women during pregnancy', 'Obese Pregnant Women', '50 obese pregnant women', 'obese pregnant women from the early second trimester until delivery', 'obese women and the women', 'Results\n\n\nForty-nine participants completed the study']","['Placebo', 'multistrain probiotic (4 capsules of Vivomixx ® ; total of 450 billion CFU/d) or placebo', 'Multistrain probiotic', 'Probiotic supplementation', 'Multistrain Probiotic', 'probiotics', 'daily probiotic intervention', 'placebo']","['GWG, GDM, HbA1c concentrations, and infant birth weight', 'gut microbiota', 'blood glucose, gestational weight gain (GWG), and the risk of gestational diabetes mellitus [GDM and glycated hemoglobin (HbA1c', 'GWG and maternal glucose homeostasis (GDM and HbA1c', 'α-diversity over time', 'Gut Microbiota Diversity', 'infant birth weight, maternal gut microbiota, and other pregnancy outcomes']","[{'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0439671', 'cui_str': 'Gestational'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0032980', 'cui_str': 'Second trimester pregnancy'}, {'cui': 'C0011209', 'cui_str': 'Delivery procedure'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C3844104', 'cui_str': '450'}, {'cui': 'C0553561', 'cui_str': 'colony-forming unit'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C1398625', 'cui_str': 'Maternal Weight Gain'}, {'cui': 'C0085207', 'cui_str': 'Gestational diabetes mellitus'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0005612', 'cui_str': 'Birth weight'}, {'cui': 'C2985398', 'cui_str': 'Intestinal Microbiota'}, {'cui': 'C0005802', 'cui_str': 'Glucose, Blood'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0026591', 'cui_str': 'Mother'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0032972', 'cui_str': 'Outcomes, Pregnancy'}]",50.0,0.717874,"There was no significant difference in GWG, GDM, HbA1c concentrations, and infant birth weight between groups.","[{'ForeName': 'Sofie Ingdam', 'Initials': 'SI', 'LastName': 'Halkjær', 'Affiliation': 'Gastrounit, Medical Division, Copenhagen University Hospital Hvidovre, Hvidovre, Denmark.'}, {'ForeName': 'Victoria Elizabeth', 'Initials': 'VE', 'LastName': 'de Knegt', 'Affiliation': 'Department of Pediatrics, Copenhagen University Hospital Hvidovre, Hvidovre, Denmark.'}, {'ForeName': 'Bobby', 'Initials': 'B', 'LastName': 'Lo', 'Affiliation': 'Gastrounit, Medical Division, Copenhagen University Hospital Hvidovre, Hvidovre, Denmark.'}, {'ForeName': 'Lisbeth', 'Initials': 'L', 'LastName': 'Nilas', 'Affiliation': 'Department of Obstetrics and Gynaecology, Copenhagen University Hospital Hvidovre, Hvidovre, Denmark.'}, {'ForeName': 'Dina', 'Initials': 'D', 'LastName': 'Cortes', 'Affiliation': 'Department of Pediatrics, Copenhagen University Hospital Hvidovre, Hvidovre, Denmark.'}, {'ForeName': 'Anders Elm', 'Initials': 'AE', 'LastName': 'Pedersen', 'Affiliation': 'Department of Dentistry, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Hengameh Chloé', 'Initials': 'HC', 'LastName': 'Mirsepasi-Lauridsen', 'Affiliation': 'Department of Bacteria, Parasites and Fungi, Statens Serum Institut, Copenhagen, Denmark.'}, {'ForeName': ""Lee O'Brien"", 'Initials': 'LO', 'LastName': 'Andersen', 'Affiliation': 'Department of Bacteria, Parasites and Fungi, Statens Serum Institut, Copenhagen, Denmark.'}, {'ForeName': 'Henrik Vedel', 'Initials': 'HV', 'LastName': 'Nielsen', 'Affiliation': 'Department of Bacteria, Parasites and Fungi, Statens Serum Institut, Copenhagen, Denmark.'}, {'ForeName': 'Christen Rune', 'Initials': 'CR', 'LastName': 'Stensvold', 'Affiliation': 'Department of Bacteria, Parasites and Fungi, Statens Serum Institut, Copenhagen, Denmark.'}, {'ForeName': 'Thor Bech', 'Initials': 'TB', 'LastName': 'Johannesen', 'Affiliation': 'Department of Bacteria, Parasites and Fungi, Statens Serum Institut, Copenhagen, Denmark.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Kallemose', 'Affiliation': 'Clinical Research Centre, Copenhagen University Hospital Hvidovre, Hvidovre, Denmark.'}, {'ForeName': 'Karen Angeliki', 'Initials': 'KA', 'LastName': 'Krogfelt', 'Affiliation': 'Department of Bacteria, Parasites and Fungi, Statens Serum Institut, Copenhagen, Denmark.'}, {'ForeName': 'Andreas Munk', 'Initials': 'AM', 'LastName': 'Petersen', 'Affiliation': 'Gastrounit, Medical Division, Copenhagen University Hospital Hvidovre, Hvidovre, Denmark.'}]",Current developments in nutrition,['10.1093/cdn/nzaa095'] 2891,32617528,A behavioral economic intervention to increase psychiatrist adherence to tobacco treatment guidelines: a provider-randomized study protocol.,"Background People with a psychiatric diagnosis smoke at high rates, yet are rarely treated for tobacco use. Health care systems often use a 'no treatment' default for tobacco, such that providers must actively choose (opt-in) to treat their patients who express interest in quitting. Default bias theory suggests that opt-in systems may reinforce the status quo to not treat tobacco use in psychiatry. We aim to conduct a pilot study testing an opt-out system for implementing a 3A's (ask, advise, assist) tobacco treatment model in outpatient psychiatry. Methods We will use a mixed-methods, cluster-randomized study design. We will implement a tobacco use clinical reminder for outpatient psychiatrists at the VA New York Harbor Healthcare System. Psychiatrists (N = 20) will be randomized 1:1 to one of two groups: (1) Opt-In Treatment Approach: Psychiatrists will receive a reminder that encourages them to offer cessation medications and referral to cessation counseling; or (2) Opt-Out Treatment Approach: Psychiatrists will receive a clinical reminder that includes a standing cessation medication order and a referral to cessation counseling that will automatically generate unless the provider cancels. Prior to implementation of the reminders, we will hold a 1-hour training on tobacco treatment for psychiatrists in both arms. We will use VA administrative data to calculate the study's primary outcomes: 1) the percent of smokers prescribed a cessation medication and 2) the percent of smokers referred to counseling. During the intervention period, we will also conduct post-visit surveys with a cluster sample of 400 patients (20 per psychiatrist) to assess psychiatrist fidelity to the 3 A's approach and patient perceptions of the opt-out system. At six months, we will survey the clustered patient sample again to evaluate the study's secondary outcomes: 1) patient use of cessation treatment in the prior 6 months and 2) self-reported 7-day abstinence at 6 months. At the end of the intervention period, we will conduct semi-structured interviews with 12-14 psychiatrists asking about their perceptions of the opt-out approach. Discussion This study will produce important data on the potential of opt-out systems to overcome barriers in implementing tobacco use treatment in outpatient psychiatry. Trial registration Clinicaltrials.gov Identifier NCT04071795 (registered August 28, 2019). https://www.clinicaltrials.gov/ct2/show/NCT04071795.",2020,"This study will produce important data on the potential of opt-out systems to overcome barriers in implementing tobacco use treatment in outpatient psychiatry. ","['Psychiatrists (N = 20', '\n\n\nPeople with a psychiatric diagnosis smoke']",['behavioral economic intervention'],"['psychiatrist adherence', 'patient use of cessation treatment in the prior 6 months and 2) self-reported 7-day abstinence']","[{'cui': 'C0033872', 'cui_str': 'Psychiatrist'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0376338', 'cui_str': 'Psychiatric Diagnosis'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}]","[{'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0013556', 'cui_str': 'Economics'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0033872', 'cui_str': 'Psychiatrist'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332152', 'cui_str': 'Before'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0036899', 'cui_str': 'Celibacy'}]",20.0,0.0863809,"This study will produce important data on the potential of opt-out systems to overcome barriers in implementing tobacco use treatment in outpatient psychiatry. ","[{'ForeName': 'Erin S', 'Initials': 'ES', 'LastName': 'Rogers', 'Affiliation': 'NYU School of Medicine, Department of Population Health, 180 Madison Avenue, New York, NY 10016.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Wysota', 'Affiliation': 'NYU School of Medicine, Department of Population Health, 180 Madison Avenue, New York, NY 10016.'}, {'ForeName': 'Judith J', 'Initials': 'JJ', 'LastName': 'Prochaska', 'Affiliation': 'Stanford University, Department of Medicine, Stanford Prevention Research Center, 1265 Welch Road St, Stanford, California 94305.'}, {'ForeName': 'Craig', 'Initials': 'C', 'LastName': 'Tenner', 'Affiliation': 'VA NY Harbor Healthcare System, 423 East 23 Street, New York, NY 10010.'}, {'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Dognin', 'Affiliation': 'VA NY Harbor Healthcare System, 423 East 23 Street, New York, NY 10010.'}, {'ForeName': 'Binhuan', 'Initials': 'B', 'LastName': 'Wang', 'Affiliation': 'NYU School of Medicine, Department of Population Health, 180 Madison Avenue, New York, NY 10016.'}, {'ForeName': 'Scott E', 'Initials': 'SE', 'LastName': 'Sherman', 'Affiliation': 'NYU School of Medicine, Department of Population Health, 180 Madison Avenue, New York, NY 10016; VA NY Harbor Healthcare System, 423 East 23 Street, New York, NY 10010.'}]",Implementation science communications,['10.1186/s43058-020-00011-x'] 2892,32617529,Stratified care versus usual care for management of patients presenting with sciatica in primary care (SCOPiC): a randomised controlled trial.,"Background Sciatica has a substantial impact on individuals and society. Stratified care has been shown to lead to better outcomes among patients with non-specific low back pain, but it has not been tested for sciatica. We aimed to investigate the clinical and cost-effectiveness of stratified care versus non-stratified usual care for patients presenting with sciatica in primary care. Methods We did a two-parallel arm, pragmatic, randomised controlled trial across three centres in the UK (North Staffordshire, North Shropshire/Wales, and Cheshire). Eligible patients were aged 18 years or older, had a clinical diagnosis of sciatica, access to a mobile phone or landline number, were not pregnant, were not currently receiving treatment for the same problem, and had no previous spinal surgery. Patients were recruited from general practices and randomly assigned (1:1) by a remote web-based service to stratified care or usual care, stratified by centre and stratification group allocation. In the stratified care arm, a combination of prognostic and clinical criteria associated with referral to spinal specialist services were used to allocate patients to one of three groups for matched care pathways. Group 1 was offered brief advice and support in up to two physiotherapy sessions; group 2 was offered up to six physiotherapy sessions; and group 3 was fast-tracked to MRI and spinal specialist assessment within 4 weeks of randomisation. The primary outcome was self-reported time to first resolution of sciatica symptoms, defined as ""completely recovered"" or ""much better"" on a 6-point ordinal scale, collected via text messages or telephone calls. Analyses were by intention to treat. Health-care costs and cost-effectiveness were also assessed. This trial is registered on the ISRCTN registry, ISRCTN75449581. Findings Between May 28, 2015, and July 18, 2017, 476 patients from 42 general practices around three UK centres were randomly assigned to stratified care or usual care (238 in each arm). For the primary outcome, the overall response rate was 89% (9467 of 10 601 text messages sent; 4688 [88%] of 5310 in the stratified care arm and 4779 [90%] of 5291 in the usual care arm). Median time to symptom resolution was 10 weeks (95% CI 6·4-13·6) in the stratified care arm and 12 weeks (9·4-14·6) in the usual care arm, with the survival analysis showing no significant difference between the arms (hazard ratio 1·14 [95% CI 0·89-1·46]). Stratified care was not cost-effective compared to usual care. Interpretation The stratified care model for patients with sciatica consulting in primary care was not better than usual care for either clinical or health economic outcomes. These results do not support a transition to this stratified care model for patients with sciatica. Funding National Institute for Health Research.",2020,The stratified care model for patients with sciatica consulting in primary care was not better than usual care for either clinical or health economic outcomes.,"['patients presenting with sciatica in primary care (SCOPiC', 'three centres in the UK (North Staffordshire, North Shropshire/Wales, and Cheshire', 'Eligible patients were aged 18 years or older, had a clinical diagnosis of sciatica, access to a mobile phone or landline number, were not pregnant, were not currently receiving treatment for the same problem, and had no previous spinal surgery', 'Findings\n\n\nBetween May 28, 2015, and July 18, 2017', 'patients with sciatica consulting in primary care was not better than usual care for either clinical or health economic outcomes', '476 patients from 42 general practices around three UK centres', 'patients with sciatica', 'patients with non-specific low back pain', 'patients presenting with sciatica in primary care']","['stratified care versus non-stratified usual care', 'remote web-based service to stratified care or usual care, stratified by centre and stratification group allocation', 'Stratified care versus usual care']","['Median time to symptom resolution', 'overall response rate', 'self-reported time to first resolution of sciatica symptoms, defined as ""completely recovered"" or ""much better"" on a 6-point ordinal scale, collected via text messages or telephone calls', 'Health-care costs and cost-effectiveness']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0036396', 'cui_str': 'Sciatica'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0454875', 'cui_str': 'Staffordshire'}, {'cui': 'C0454872', 'cui_str': 'Shropshire'}, {'cui': 'C0043015', 'cui_str': 'Wales'}, {'cui': 'C0454844', 'cui_str': 'Cheshire'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0332140', 'cui_str': 'Clinical diagnosis'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C1136360', 'cui_str': 'Car Phone'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0232973', 'cui_str': 'Not pregnant'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0033213', 'cui_str': 'Problem'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0037088', 'cui_str': 'Clinical finding'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0013560', 'cui_str': 'Medical Economics'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0015607', 'cui_str': 'Family practice'}, {'cui': 'C0205370', 'cui_str': 'Non-specific'}, {'cui': 'C0024031', 'cui_str': 'Low back pain'}]","[{'cui': 'C0205363', 'cui_str': 'Stratified'}, {'cui': 'C0205157', 'cui_str': 'Remote'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0557854', 'cui_str': 'Services'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0036396', 'cui_str': 'Sciatica'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0521108', 'cui_str': 'Recovering from'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C0439080', 'cui_str': 'Ordinal number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C1720420', 'cui_str': 'Call'}, {'cui': 'C0085552', 'cui_str': 'Health Costs'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}]",10601.0,0.132369,The stratified care model for patients with sciatica consulting in primary care was not better than usual care for either clinical or health economic outcomes.,"[{'ForeName': 'Kika', 'Initials': 'K', 'LastName': 'Konstantinou', 'Affiliation': 'Primary Care Centre Versus Arthritis, School of Primary, Community and Social Care, Keele University, Keele, UK.'}, {'ForeName': 'Martyn', 'Initials': 'M', 'LastName': 'Lewis', 'Affiliation': 'Primary Care Centre Versus Arthritis, School of Primary, Community and Social Care, Keele University, Keele, UK.'}, {'ForeName': 'Kate M', 'Initials': 'KM', 'LastName': 'Dunn', 'Affiliation': 'Primary Care Centre Versus Arthritis, School of Primary, Community and Social Care, Keele University, Keele, UK.'}, {'ForeName': 'Reuben', 'Initials': 'R', 'LastName': 'Ogollah', 'Affiliation': 'Nottingham Clinical Trials Unit, School of Medicine, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Majid', 'Initials': 'M', 'LastName': 'Artus', 'Affiliation': 'Primary Care Centre Versus Arthritis, School of Primary, Community and Social Care, Keele University, Keele, UK.'}, {'ForeName': 'Jonathan C', 'Initials': 'JC', 'LastName': 'Hill', 'Affiliation': 'Primary Care Centre Versus Arthritis, School of Primary, Community and Social Care, Keele University, Keele, UK.'}, {'ForeName': 'Gemma', 'Initials': 'G', 'LastName': 'Hughes', 'Affiliation': 'Keele Clinical Trials Unit, Keele University, Keele, UK.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Robinson', 'Affiliation': 'Keele Clinical Trials Unit, Keele University, Keele, UK.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Saunders', 'Affiliation': 'Primary Care Centre Versus Arthritis, School of Primary, Community and Social Care, Keele University, Keele, UK.'}, {'ForeName': 'Bernadette', 'Initials': 'B', 'LastName': 'Bartlam', 'Affiliation': 'Primary Care Centre Versus Arthritis, School of Primary, Community and Social Care, Keele University, Keele, UK.'}, {'ForeName': 'Jesse', 'Initials': 'J', 'LastName': 'Kigozi', 'Affiliation': 'Health Economics unit, Institute of Applied Health Research, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Sue', 'Initials': 'S', 'LastName': 'Jowett', 'Affiliation': 'Primary Care Centre Versus Arthritis, School of Primary, Community and Social Care, Keele University, Keele, UK.'}, {'ForeName': 'Christian D', 'Initials': 'CD', 'LastName': 'Mallen', 'Affiliation': 'Primary Care Centre Versus Arthritis, School of Primary, Community and Social Care, Keele University, Keele, UK.'}, {'ForeName': 'Elaine M', 'Initials': 'EM', 'LastName': 'Hay', 'Affiliation': 'Primary Care Centre Versus Arthritis, School of Primary, Community and Social Care, Keele University, Keele, UK.'}, {'ForeName': 'Danielle A', 'Initials': 'DA', 'LastName': 'van der Windt', 'Affiliation': 'Primary Care Centre Versus Arthritis, School of Primary, Community and Social Care, Keele University, Keele, UK.'}, {'ForeName': 'Nadine E', 'Initials': 'NE', 'LastName': 'Foster', 'Affiliation': 'Primary Care Centre Versus Arthritis, School of Primary, Community and Social Care, Keele University, Keele, UK.'}]",The Lancet Rheumatology,['10.1016/S2665-9913(20)30099-0'] 2893,32617578,Direct Renin Inhibition in Non-diabetic chronic Kidney disease (DRINK): a prospective randomized trial.,"BACKGROUND The potential long-term safety and efficacy of aliskiren in nondiabetic chronic kidney disease (CKD) are unknown. We sought to investigate the renoprotective effect of aliskiren on nondiabetic CKD patients. METHODS In this open-label, parallel, randomized controlled trial, nondiabetic CKD Stages 3-4 patients were randomized to receive aliskiren added to an angiotensin II receptor blocker (ARB) at the maximal tolerated dose, or ARB alone. Primary outcome was the rate of change in estimated glomerular filtration rate (eGFR). Secondary endpoints included rate of change in urine protein-to-creatinine ratio (UPCR), cardiovascular events and hyperkalemia. Composite renal outcomes of doubling of baseline serum creatinine or a 40% reduction in eGFR or incident end-stage renal disease or death were analyzed as post hoc analysis. RESULTS Seventy-six patients were randomized: 37 to aliskiren (mean age 55.1 ± 11.1 years) and 39 to control (mean age 55.0 ± 9.4 years). Their baseline demographics were comparable to eGFR (31.9 ± 9.0 versus 27.7 ± 9.0 mL/min/1.73 m2, P = 0.05) and UPCR (30.7 ± 12.6 versus 47.8 ± 2.8 mg/mmol, P = 0.33) for treatment versus control subjects. After 144 weeks of follow-up, there was no difference in the rate of eGFR change between groups. Six patients in the aliskiren group and seven in the control group reached the renal composite endpoint (16.2% versus 17.9%, P = 0.84). The cardiovascular event rate was 10.8% versus 2.6% (P = 0.217). The hyperkalemia rate was 18.9% versus 5.1% with an adjusted hazard ratio of 7.71 (95% confidence interval 1.14 to 52.3, P = 0.04) for the aliskiren arm. CONCLUSION Aliskiren neither conferred additional renoprotective benefit nor increased adverse events, except for more hyperkalemia in nondiabetic CKD patients.",2020,The cardiovascular event rate was 10.8% versus 2.6% (P = 0.217).,"['Seventy-six patients were randomized: 37 to', 'mean age 55.0\u2009±\u20099.4\u2009years', 'nondiabetic CKD Stages 3-4 patients', 'mean age 55.1\u2009±\u200911.1\u2009years) and 39 to control ', 'Non-diabetic chronic Kidney disease (DRINK', 'nondiabetic CKD patients', 'nondiabetic chronic kidney disease (CKD']","['aliskiren', 'Aliskiren', 'Direct Renin Inhibition', 'angiotensin II receptor blocker (ARB']","['eGFR or incident end-stage renal disease or death', 'renal composite endpoint', 'UPCR', 'rate of eGFR change', 'hyperkalemia', 'adverse events', 'hyperkalemia rate', 'rate of change in urine protein-to-creatinine ratio (UPCR), cardiovascular events and hyperkalemia', 'cardiovascular event rate', 'rate of change in estimated glomerular filtration rate (eGFR']","[{'cui': 'C4319622', 'cui_str': '76'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1561643', 'cui_str': 'Chronic kidney disease'}, {'cui': 'C0442757', 'cui_str': '3/4'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0452428', 'cui_str': 'Drink'}]","[{'cui': 'C1120110', 'cui_str': 'aliskiren'}, {'cui': 'C0373719', 'cui_str': 'Renin measurement'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0521942', 'cui_str': 'Angiotensin II receptor antagonist'}]","[{'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0022661', 'cui_str': 'Chronic renal failure'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0262923', 'cui_str': 'Urine protein test'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0020461', 'cui_str': 'Hyperkalemia'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}]",76.0,0.168689,The cardiovascular event rate was 10.8% versus 2.6% (P = 0.217).,"[{'ForeName': 'Sydney C W', 'Initials': 'SCW', 'LastName': 'Tang', 'Affiliation': 'Division of Nephrology, Department of Medicine, The University of Hong Kong and Queen Mary Hospital, Hong Kong, China.'}, {'ForeName': 'Kam Wa', 'Initials': 'KW', 'LastName': 'Chan', 'Affiliation': 'Division of Nephrology, Department of Medicine, The University of Hong Kong and Queen Mary Hospital, Hong Kong, China.'}, {'ForeName': 'Dennis K M', 'Initials': 'DKM', 'LastName': 'Ip', 'Affiliation': 'School of Public Health, The University of Hong Kong, Hong Kong, China.'}, {'ForeName': 'Desmond Y H', 'Initials': 'DYH', 'LastName': 'Yap', 'Affiliation': 'Division of Nephrology, Department of Medicine, The University of Hong Kong and Queen Mary Hospital, Hong Kong, China.'}, {'ForeName': 'Maggie K M', 'Initials': 'MKM', 'LastName': 'Ma', 'Affiliation': 'Division of Nephrology, Department of Medicine, The University of Hong Kong and Queen Mary Hospital, Hong Kong, China.'}, {'ForeName': 'Maggie M Y', 'Initials': 'MMY', 'LastName': 'Mok', 'Affiliation': 'Division of Nephrology, Department of Medicine, The University of Hong Kong and Queen Mary Hospital, Hong Kong, China.'}, {'ForeName': 'Gary C W', 'Initials': 'GCW', 'LastName': 'Chan', 'Affiliation': 'Division of Nephrology, Department of Medicine, The University of Hong Kong and Queen Mary Hospital, Hong Kong, China.'}, {'ForeName': 'Sidney', 'Initials': 'S', 'LastName': 'Tam', 'Affiliation': 'Department of Clinical Biochemistry, Queen Mary Hospital, Hong Kong, China.'}, {'ForeName': 'Kar Neng', 'Initials': 'KN', 'LastName': 'Lai', 'Affiliation': 'Division of Nephrology, Department of Medicine, The University of Hong Kong and Queen Mary Hospital, Hong Kong, China.'}]","Nephrology, dialysis, transplantation : official publication of the European Dialysis and Transplant Association - European Renal Association",['10.1093/ndt/gfaa085'] 2894,32617667,Neoadjuvant chemotherapy plus surgery for high-risk advanced gastric cancer: long-term results of KDOG1001 trial.,"PURPOSE The purpose of this study is to evaluate the long-term survival outcomes of KDOG1001 trial after a minimum follow-up of 3 years. METHODS Patients with bulky N2 lymph nodes, linitis plastica (type 4), or large ulcero-invasive-type tumors (type 3) received up to four 28-day cycles of DCS neoadjuvant chemotherapy (docetaxel at 40 mg/m 2 , cisplatin at 60 mg/m 2 on day 1, and S-1 at 40 mg/m 2 twice daily for 2 weeks) followed by gastrectomy with D2 lymphadenectomy plus adjuvant S-1 therapy for 1 year. The final preplanned analysis of long-term outcomes including overall survival and relapse-free survival was conducted after minimum follow-up of 3 years. This trial is registered with the University Hospital Medical Information Network Clinical Trials Registry, number UMIN 000003642, and has been completed. RESULTS From May 2010 through January 2017, 40 patients were enrolled. All included patients underwent neoadjuvant chemotherapy with DCS followed by gastrectomy with D2 lymphadenectomy, and 32 (80%) completed adjuvant S-1 therapy for 1 year. After a median follow-up for surviving patients of 68 months at the last follow-up in January 2020, 3-year overall survival rate was 77.5% (95% confidence interval 62.1-87.9%), while 3-year relapse-free survival rate was 62.5% (95% confidence interval 46.8-76.0%). CONCLUSION Neoadjuvant chemotherapy with 4 cycles of DCS followed by D2 gastrectomy plus adjuvant S-1 was associated with relatively good long-term oncologic outcomes for patients with the high-risk gastric cancer.",2020,"CONCLUSION Neoadjuvant chemotherapy with 4 cycles of DCS followed by D2 gastrectomy plus adjuvant S-1 was associated with relatively good long-term oncologic outcomes for patients with the high-risk gastric cancer.","['high-risk advanced gastric cancer', 'From May 2010 through January 2017, 40 patients were enrolled', 'Patients with bulky N2 lymph nodes, linitis plastica ', 'type 4), or large ulcero-invasive-type tumors (type 3', 'patients with the high-risk gastric cancer']","['DCS neoadjuvant chemotherapy (docetaxel at 40\xa0mg/m 2 , cisplatin at 60\xa0mg/m 2 on day 1, and S-1 at 40\xa0mg/m 2 twice daily for 2\xa0weeks) followed by gastrectomy with D2 lymphadenectomy plus adjuvant S-1 therapy', 'D2 gastrectomy plus adjuvant S-1', 'neoadjuvant chemotherapy with DCS followed by gastrectomy with D2 lymphadenectomy', 'adjuvant S-1 therapy', 'Neoadjuvant chemotherapy plus surgery']","['3-year relapse-free survival rate', 'overall survival and relapse-free survival', '3-year overall survival rate']","[{'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0024623', 'cui_str': 'Malignant tumor of stomach'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0024204', 'cui_str': 'Structure of lymph node'}, {'cui': 'C0023743', 'cui_str': 'Linitis plastica'}, {'cui': 'C0441732', 'cui_str': 'Type 4'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0441731', 'cui_str': 'Type 3'}]","[{'cui': 'C0010590', 'cui_str': 'Cycloserine'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0879262', 'cui_str': 'S 1 (combination)'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C0017118', 'cui_str': 'Gastrectomy'}, {'cui': 'C0024203', 'cui_str': 'Excision of lymph node'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0001552', 'cui_str': 'Pharmaceutical Adjuvants'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0038954', 'cui_str': 'Survival Rate'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}]",40.0,0.323054,"CONCLUSION Neoadjuvant chemotherapy with 4 cycles of DCS followed by D2 gastrectomy plus adjuvant S-1 was associated with relatively good long-term oncologic outcomes for patients with the high-risk gastric cancer.","[{'ForeName': 'Kei', 'Initials': 'K', 'LastName': 'Hosoda', 'Affiliation': 'Department of Upper Gastrointestinal Surgery, Kitasato University School of Medicine, Kitasato 1-15-1, Minami-ku, Sagamihara, 252-0374, Japan. k.hosoda@kitasato-u.ac.jp.'}, {'ForeName': 'Chikatoshi', 'Initials': 'C', 'LastName': 'Katada', 'Affiliation': 'Department of Gastroenterology, Kitasato University School of Medicine, Sagamihara, Japan.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Ishido', 'Affiliation': 'Department of Gastroenterology, Kitasato University School of Medicine, Sagamihara, Japan.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Niihara', 'Affiliation': 'Department of Upper Gastrointestinal Surgery, Kitasato University School of Medicine, Kitasato 1-15-1, Minami-ku, Sagamihara, 252-0374, Japan.'}, {'ForeName': 'Hideki', 'Initials': 'H', 'LastName': 'Ushiku', 'Affiliation': 'Department of Upper Gastrointestinal Surgery, Kitasato University School of Medicine, Kitasato 1-15-1, Minami-ku, Sagamihara, 252-0374, Japan.'}, {'ForeName': 'Mikiko', 'Initials': 'M', 'LastName': 'Sakuraya', 'Affiliation': 'Department of Upper Gastrointestinal Surgery, Kitasato University School of Medicine, Kitasato 1-15-1, Minami-ku, Sagamihara, 252-0374, Japan.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Washio', 'Affiliation': 'Department of Upper Gastrointestinal Surgery, Kitasato University School of Medicine, Kitasato 1-15-1, Minami-ku, Sagamihara, 252-0374, Japan.'}, {'ForeName': 'Takuya', 'Initials': 'T', 'LastName': 'Wada', 'Affiliation': 'Department of Gastroenterology, Kitasato University School of Medicine, Sagamihara, Japan.'}, {'ForeName': 'Akinori', 'Initials': 'A', 'LastName': 'Watanabe', 'Affiliation': 'Department of Gastroenterology, Kitasato University School of Medicine, Sagamihara, Japan.'}, {'ForeName': 'Hiroki', 'Initials': 'H', 'LastName': 'Harada', 'Affiliation': 'Department of Upper Gastrointestinal Surgery, Kitasato University School of Medicine, Kitasato 1-15-1, Minami-ku, Sagamihara, 252-0374, Japan.'}, {'ForeName': 'Takeo', 'Initials': 'T', 'LastName': 'Sato', 'Affiliation': 'Department of Lower Gastrointestinal Surgery, Kitasato University School of Medicine, Sagamihara, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Tajima', 'Affiliation': 'Department of General-Pediatric-Hepatobiliary Pancreatic Surgery, Kitasato University School of Medicine, Sagamihara, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Kaizu', 'Affiliation': 'Department of General-Pediatric-Hepatobiliary Pancreatic Surgery, Kitasato University School of Medicine, Sagamihara, Japan.'}, {'ForeName': 'Yoshimasa', 'Initials': 'Y', 'LastName': 'Kosaka', 'Affiliation': 'Department of Breast and Thyroid Surgery, Kitasato University School of Medicine, Sagamihara, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Kato', 'Affiliation': 'Department of Breast and Thyroid Surgery, Kitasato University School of Medicine, Sagamihara, Japan.'}, {'ForeName': 'Norihiko', 'Initials': 'N', 'LastName': 'Sengoku', 'Affiliation': 'Department of Breast and Thyroid Surgery, Kitasato University School of Medicine, Sagamihara, Japan.'}, {'ForeName': 'Kiyoshi', 'Initials': 'K', 'LastName': 'Tanaka', 'Affiliation': 'Department of General-Pediatric-Hepatobiliary Pancreatic Surgery, Kitasato University School of Medicine, Sagamihara, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Naito', 'Affiliation': 'Department of Lower Gastrointestinal Surgery, Kitasato University School of Medicine, Sagamihara, Japan.'}, {'ForeName': 'Yusuke', 'Initials': 'Y', 'LastName': 'Kumamoto', 'Affiliation': 'Department of General-Pediatric-Hepatobiliary Pancreatic Surgery, Kitasato University School of Medicine, Sagamihara, Japan.'}, {'ForeName': 'Takafumi', 'Initials': 'T', 'LastName': 'Sangai', 'Affiliation': 'Department of Breast and Thyroid Surgery, Kitasato University School of Medicine, Sagamihara, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Tanabe', 'Affiliation': 'Department of Gastroenterology, Kitasato University School of Medicine, Sagamihara, Japan.'}, {'ForeName': 'Wasaburo', 'Initials': 'W', 'LastName': 'Koizumi', 'Affiliation': 'Department of Gastroenterology, Kitasato University School of Medicine, Sagamihara, Japan.'}, {'ForeName': 'Keishi', 'Initials': 'K', 'LastName': 'Yamashita', 'Affiliation': 'Department of Upper Gastrointestinal Surgery, Kitasato University School of Medicine, Kitasato 1-15-1, Minami-ku, Sagamihara, 252-0374, Japan.'}, {'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Hiki', 'Affiliation': 'Department of Upper Gastrointestinal Surgery, Kitasato University School of Medicine, Kitasato 1-15-1, Minami-ku, Sagamihara, 252-0374, Japan.'}]",Langenbeck's archives of surgery,['10.1007/s00423-020-01924-w'] 2895,32617701,"A randomized, double-blind, placebo controlled, phase II study to evaluate the efficacy of ginseng in reducing fatigue in patients treated for head and neck cancer.","PURPOSE Fatigue is a distressing symptom in head & neck cancer patients before during and at the end of curative therapy. Pharmacologic and not pharmacologic treatments have been proposed with scarce or no evidence of efficacy. The aim of the study is to evaluate the efficacy of American ginseng in respect to placebo in reducing fatigue in patients treated for head and neck cancer with curative intent. METHODS Thirty-two patients who had completed oncological treatment for a primary Head & neck tumor for at least 1 year and had a global fatigue score > 4 by means of Brief Fatigue Inventory (BFI) were randomized to receive 1000 mg of American ginseng or placebo per day for 8 weeks with the aim to assess their efficacy. Changes in fatigue scores in the 2 subgroups of patients before and after the treatment with American ginseng or placebo, were assessed by the BFI at baseline and at the end of week 8. RESULTS The mean of the mean values of the BFI measured at 8 weeks (end of treatment) was 4.6 in the Ginseng arm and 3.4 in the Placebo arm (p = ns). Mean comparison showed a tendency to statistical significance only for the single item on interference with general activity (p = 0.06), with better performance for placebo. The mean of the differences between baseline values and 8 weeks values was not significantly different between treatment arms considering the entire questionnaire. CONCLUSION The present data shows that American ginseng has insufficient evidence to be recommended for Cancer Related Fatigue (CRF) in post treatment HNC survivors.",2020,"The mean of the differences between baseline values and 8 weeks values was not significantly different between treatment arms considering the entire questionnaire. ","['patients treated for head and neck cancer', 'patients treated for head and neck cancer with curative intent', 'head & neck cancer patients before during and at the end of curative therapy', 'Thirty-two patients who had completed oncological treatment for a primary Head & neck tumor for at least 1\xa0year and had a global fatigue score\u2009>\u20094 by means of Brief Fatigue Inventory (BFI']","['American ginseng', 'American ginseng or placebo', 'Placebo', 'ginseng', 'placebo']","['fatigue scores', 'mean of the mean values of the BFI']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for'}, {'cui': 'C0278996', 'cui_str': 'Malignant tumor of head and neck'}, {'cui': 'C1276305', 'cui_str': 'Curative - procedure intent'}, {'cui': 'C1283828', 'cui_str': 'Has intent'}, {'cui': 'C0018670', 'cui_str': 'Head structure'}, {'cui': 'C0746787', 'cui_str': 'Malignant tumor of neck'}, {'cui': 'C0444930', 'cui_str': 'End'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0450357', 'cui_str': '32'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0027533', 'cui_str': 'Neoplasm of neck'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}]","[{'cui': 'C1119918', 'cui_str': 'Ginseng Preparation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0086767', 'cui_str': 'Ginseng'}]","[{'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0453896', 'cui_str': 'Briefs'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}]",32.0,0.258747,"The mean of the differences between baseline values and 8 weeks values was not significantly different between treatment arms considering the entire questionnaire. ","[{'ForeName': 'Mauro', 'Initials': 'M', 'LastName': 'Guglielmo', 'Affiliation': 'Oncology Supportive Care in Cancer Unit, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy. mauro.guglielmo@istitutotumori.mi.it.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Di Pede', 'Affiliation': 'Oncology Supportive Care in Cancer Unit, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.'}, {'ForeName': 'Salvatore', 'Initials': 'S', 'LastName': 'Alfieri', 'Affiliation': 'Head and Neck Medical Oncology - Fondazione, IRCCS Istituto Nazionale dei Tumori, Milano and University of Milan, Milan, Italy.'}, {'ForeName': 'Cristiana', 'Initials': 'C', 'LastName': 'Bergamini', 'Affiliation': 'Head and Neck Medical Oncology - Fondazione, IRCCS Istituto Nazionale dei Tumori, Milano and University of Milan, Milan, Italy.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Platini', 'Affiliation': 'Head and Neck Medical Oncology - Fondazione, IRCCS Istituto Nazionale dei Tumori, Milano and University of Milan, Milan, Italy.'}, {'ForeName': 'Carla Ida', 'Initials': 'CI', 'LastName': 'Ripamonti', 'Affiliation': 'Oncology Supportive Care in Cancer Unit, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.'}, {'ForeName': 'Ester', 'Initials': 'E', 'LastName': 'Orlandi', 'Affiliation': 'Radiation Oncology Department, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.'}, {'ForeName': 'Nicola Alessandro', 'Initials': 'NA', 'LastName': 'Iacovelli', 'Affiliation': 'Radiation Oncology Department, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Licitra', 'Affiliation': 'Head and Neck Medical Oncology - Fondazione, IRCCS Istituto Nazionale dei Tumori, Milano and University of Milan, Milan, Italy.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Maddalo', 'Affiliation': 'Radiation Oncology Department, ASST Spedali Civili di Brescia - University of Brescia, Brescia, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Bossi', 'Affiliation': 'Head and Neck Medical Oncology - Fondazione, IRCCS Istituto Nazionale dei Tumori, Milano and University of Milan, Milan, Italy.'}]",Journal of cancer research and clinical oncology,['10.1007/s00432-020-03300-z'] 2896,32617881,Priming Before In Vitro Maturation Cycles in Cancer Patients Undergoing Urgent Fertility Preservation: a Randomized Controlled Study.,"In vitro maturation (IVM) of oocytes retrieved at germinal vesicle stage, followed by vitrification of mature oocytes, has emerged as a fertility preservation (FP) option. This technique was first developed for patients with polycystic ovarian syndrome. In this population, providing LH activity prior to oocyte collection has been associated with better IVM outcomes. However, the benefit of this treatment in normo-ovulatory breast cancer (BC) patients undergoing IVM for FP purpose has never been investigated. To assess if the absence of therapeutic intervention prior to oocyte retrieval for IVM modifies IVM outcomes in BC patients undergoing urgent FP, we performed a non-inferiority, randomized controlled trial. The main outcome was the total number of mature oocytes obtained and cryopreserved after IVM. A total of 172 normo-ovulatory women, suffering from BC, 18 to 39 years of age received no injection or a subcutaneous injection of hCG or GnRH agonist (GnRHa) 36 h before oocytes retrieval according to randomized allocation. The total number of cryopreserved oocytes were 5.1 ± 3.8, 5.4 ± 3.8, and 6.0 ± 4.2 oocytes, respectively in the without, hCG and GnRHa groups. Mean differences were not significant between the three groups (- 0.5; CI 97.5% [- 2.03:1.02] and - 0.22; CI 97.5% [- 1.75:1.32], respectively). Intention to treat analyses failed to show non-inferiority in the ""without injection group"" in comparison with hCG or GnRHa groups. Our results are not conclusive enough to modify our practices and to stop administering hCG or GnRHa before IVM cycles for FP. The study was retrospectively registered to clinical trial (ID NCT03954197) in May 2019.",2020,"Intention to treat analyses failed to show non-inferiority in the ""without injection group"" in comparison with hCG or GnRHa groups.","['Cancer Patients', 'Undergoing Urgent Fertility Preservation', 'BC patients undergoing urgent FP', '172 normo-ovulatory women, suffering from BC, 18 to 39\xa0years of age received no injection or a subcutaneous injection of hCG or GnRH agonist (GnRHa) 36\xa0h before oocytes retrieval according to randomized allocation', 'patients with polycystic ovarian syndrome']",[],"['total number of cryopreserved oocytes', 'total number of mature oocytes obtained and cryopreserved after IVM']","[{'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439609', 'cui_str': 'Urgent'}, {'cui': 'C1171194', 'cui_str': 'Fertility care'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}, {'cui': 'C4517601', 'cui_str': '172'}, {'cui': 'C0429470', 'cui_str': 'Ovulatory'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0021499', 'cui_str': 'Subcutaneous injection'}, {'cui': 'C1141639', 'cui_str': 'Human chorionic gonadotropin'}, {'cui': 'C1518041', 'cui_str': 'Gonadotropin releasing hormone analogues'}, {'cui': 'C0404268', 'cui_str': 'Oocyte recovery'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0032460', 'cui_str': 'Polycystic ovary syndrome'}]",[],"[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0029045', 'cui_str': 'Oocyte'}, {'cui': 'C0205286', 'cui_str': 'Mature'}, {'cui': 'C1301820', 'cui_str': 'Obtained'}, {'cui': 'C0021135', 'cui_str': 'In Vitro'}]",,0.232947,"Intention to treat analyses failed to show non-inferiority in the ""without injection group"" in comparison with hCG or GnRHa groups.","[{'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Sonigo', 'Affiliation': 'Department of Reproductive Medicine and Fertility Preservation, Hôpital Antoine Béclère, Université Paris saclay, Assistance Publique - Hôpitaux de Paris, 92140, Clamart, France.'}, {'ForeName': 'Grégoire', 'Initials': 'G', 'LastName': 'Le Conte', 'Affiliation': 'Department of Reproductive Medicine and Fertility Preservation, Hôpital Antoine Béclère, Université Paris saclay, Assistance Publique - Hôpitaux de Paris, 92140, Clamart, France.'}, {'ForeName': 'Marouane', 'Initials': 'M', 'LastName': 'Boubaya', 'Affiliation': 'Clinical Research Unit and Clinical Research Center, Avicenne Hospital, APHP, Bobigny, France.'}, {'ForeName': 'Haykanush', 'Initials': 'H', 'LastName': 'Ohanyan', 'Affiliation': 'Clinical Research Unit and Clinical Research Center, Avicenne Hospital, APHP, Bobigny, France.'}, {'ForeName': 'Marion', 'Initials': 'M', 'LastName': 'Pressé', 'Affiliation': 'Department of Reproductive Medicine and Fertility Preservation, Hôpital Antoine Béclère, Université Paris saclay, Assistance Publique - Hôpitaux de Paris, 92140, Clamart, France.'}, {'ForeName': 'Hady', 'Initials': 'H', 'LastName': 'El Hachem', 'Affiliation': 'Department of Reproductive Medicine, Ovo Clinic, Montreal, Quebec, Canada; Department of Obstetrics and Gynecology, University of Montreal, Montreal, Quebec, Canada.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Cedrin-Durnerin', 'Affiliation': 'Department of Reproductive Medicine & Fertility Preservation, Hôpital Jean Verdier, Avenue du 14 Juillet, 93140, Bondy, France.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Benoit', 'Affiliation': 'Department of Reproductive Medicine and Fertility Preservation, Hôpital Antoine Béclère, Université Paris saclay, Assistance Publique - Hôpitaux de Paris, 92140, Clamart, France.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Sifer', 'Affiliation': 'Department of Cytogenetic and Reproductive Biology, Hôpital Jean Verdier, Avenue du 14 Juillet, 93140, Bondy, France.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Sermondade', 'Affiliation': 'Department of Cytogenetic and Reproductive Biology, Hôpital Jean Verdier, Avenue du 14 Juillet, 93140, Bondy, France.'}, {'ForeName': 'Michaël', 'Initials': 'M', 'LastName': 'Grynberg', 'Affiliation': 'Department of Reproductive Medicine and Fertility Preservation, Hôpital Antoine Béclère, Université Paris saclay, Assistance Publique - Hôpitaux de Paris, 92140, Clamart, France. michael.grynberg@aphp.fr.'}]","Reproductive sciences (Thousand Oaks, Calif.)",['10.1007/s43032-020-00244-0'] 2897,32617889,Health-related quality of life of women after HPV testing as triage strategy for an abnormal Pap smear: a nested randomized pragmatic trial in a middle-income country.,"BACKGROUND Information obtained in studies on the impact of human papilloma virus (HPV) testing on health-related quality of life is contradictory. OBJECTIVE To assess the impact on health-related quality of life of the HPV test, colposcopy, and cytology as triage strategies after a cytology with atypical squamous cells of undetermined significance (ASCUS) in Medellín, Colombia. METHODS We carried out a nested analysis on the randomized pragmatic trial (ASCUS-COL). Women with ASCUS were assigned randomly to one of the 3 arms (Pap smear, colposcopy, HPV). Participants completed a questionnaire at baseline, two weeks after receiving the results of the triage tests and one year after the second questionnaire. We used the SF-36 to assess health-related quality of life. RESULTS The sum score of the physical health component (PHC) and mental health component (MHC) increased significantly over time for the whole sample and there were no statistically significant differences between arms of PHC = survey 1: mean 52.4 (SD 8.21) vs. survey 3: mean 54.4 (SD 8.16) p < 0.0001 and of MHC = survey 1: mean 44.9 (SD 11.72) vs. survey 3: mean 48.1 (SD 11.20) p < 0.0001. A lower MHC occurred in women with lesser schooling, belonging to the public health care regimen, higher number of live births, and separated. A lower PHC was associated with the cytology arm, higher age, lesser schooling, and belonging to the subsidized regime. The risk of having depression went from 42% in the first survey to 26% in the third. CONCLUSION The triage strategies affected health-related quality of life in the same manner. ClinicalTrials.gov Identifier: NCT02067468.",2020,The sum score of the physical health component (PHC) and mental health component (MHC) increased significantly over time for the whole sample and there were no statistically significant differences between arms of PHC = survey 1: mean 52.4 (SD 8.21) vs. survey 3,"['Women with ASCUS', 'abnormal Pap smear', 'mean 44.9 (SD 11.72) vs. survey 3']",[],"['risk of having depression', 'sum score of the physical health component (PHC) and mental health component (MHC']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0521184', 'cui_str': 'Atypical squamous cells of undetermined significance'}, {'cui': 'C0476427', 'cui_str': 'Abnormal cervical smear'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}]",[],"[{'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0449432', 'cui_str': 'Component'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}]",,0.235193,The sum score of the physical health component (PHC) and mental health component (MHC) increased significantly over time for the whole sample and there were no statistically significant differences between arms of PHC = survey 1: mean 52.4 (SD 8.21) vs. survey 3,"[{'ForeName': 'Yenny', 'Initials': 'Y', 'LastName': 'Urrea Cosme', 'Affiliation': 'Grupo Atropos, Universidad de Antioquia UdeA, Calle 70 No. 52-21, Medellín, Colombia.'}, {'ForeName': 'Verónica', 'Initials': 'V', 'LastName': 'Córdoba Sánchez', 'Affiliation': 'Grupo Atropos, Universidad de Antioquia UdeA, Calle 70 No. 52-21, Medellín, Colombia.'}, {'ForeName': 'Gloria I', 'Initials': 'GI', 'LastName': 'Sánchez', 'Affiliation': 'Grupo Infección y Cáncer, Facultad de Medicina, Universidad de Antioquia UdeA, Calle 70 No. 52-21, Medellín, Colombia.'}, {'ForeName': 'Armando', 'Initials': 'A', 'LastName': 'Baena', 'Affiliation': 'Prevention and Implementation Group, International Agency for Research on Cancer / World Health Organization (IARC/WHO), 150 Cours Albert Thomas, 69372, Lyon Cedex 08, France.'}, {'ForeName': 'Mario Alberto', 'Initials': 'MA', 'LastName': 'Ruiz Osorio', 'Affiliation': 'Grupo Atropos, Universidad de Antioquia UdeA, Calle 70 No. 52-21, Medellín, Colombia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Rodríguez Zabala', 'Affiliation': 'Grupo Atropos, Universidad de Antioquia UdeA, Calle 70 No. 52-21, Medellín, Colombia.'}, {'ForeName': 'Isabel C', 'Initials': 'IC', 'LastName': 'Garcés-Palacio', 'Affiliation': 'Grupo de Epidemiología, Facultad Nacional de Salud Pública, Universidad de Antioquia UdeA, Calle 70 No. 52-21, Medellín, Colombia. icristina.garces@udea.edu.co.'}]","Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation",['10.1007/s11136-020-02563-w'] 2898,32620866,Spa therapy with physical rehabilitation is an alternative to usual spa therapy protocol in symptomatic knee osteoarthritis.,"The objective of the study was to demonstrate the non-inferiority of low-frequency spa therapy combined with rehabilitation (Spa-rehab) versus standard spa therapy at 6 months for symptomatic knee osteoarthritis (KOA). A prospective, randomized, monocenter, non-inferiority trial with recruitment of community-based symptomatic KOA patients was performed. Standard spa therapy comprised standardized spa treatment, 6 days a week for 3 weeks, and Spa-rehab therapy comprised spa sessions, 3 days a week for 3 weeks, followed by a dedicated rehabilitation program, 3 days a week for 3 weeks. The primary endpoint was achieving at 6 months a minimal clinically important improvement (MCII) for pain on a visual analog scale and/or an MCII for function on the WOMAC index and no knee surgery (composite MCII). Secondary endpoints were composite MCII at 3 months and achieving a Patient Acceptable Symptom State (PASS) for pain and function at 3 and 6 months. Among 283 patients included, 145 were allocated to standard spa therapy and 138 to Spa-rehab therapy. We could not demonstrate the non-inferiority of Spa-rehab therapy for the primary endpoint: difference for responders - 0.08 [90% CI (- 0.18 to 0.02), p = 0.14]. However, the difference test between the groups was not significant (p = 0.18). Spa-rehab therapy was not inferior to standard spa therapy for the composite MCII at 3 months or the PASS at 3 and 6 months. Spa-rehab therapy can reasonably be proposed to patients with symptomatic KOA. This protocol may be more cost-effective than standard spa therapy and avoid absenteeism from work and accommodation costs for patients who live close to a centre.",2020,Spa-rehab therapy was not inferior to standard spa therapy for the composite MCII at 3 months or the PASS at 3 and 6 months.,"['patients with symptomatic KOA', 'symptomatic knee osteoarthritis (KOA', '283 patients included, 145 were allocated to', 'patients who live close to a centre', 'symptomatic knee osteoarthritis']","['Spa therapy with physical rehabilitation', 'Spa-rehab therapy', 'standard spa therapy', 'low-frequency spa therapy combined with rehabilitation (Spa-rehab) versus standard spa therapy']","['achieving at 6\xa0months a minimal clinically important improvement (MCII) for pain on a visual analog scale and/or an MCII for function on the WOMAC index and no knee surgery (composite MCII', 'composite MCII at 3\xa0months and achieving a Patient Acceptable Symptom State (PASS) for pain and function']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0409959', 'cui_str': 'Osteoarthritis of knee'}, {'cui': 'C4708786', 'cui_str': '283'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C4517577', 'cui_str': '145'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0587267', 'cui_str': 'Closed'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C0037750', 'cui_str': 'Spanish language'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0007237', 'cui_str': 'Care involving use of rehabilitation procedure, unspecified'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C0034991', 'cui_str': 'Rehabilitation therapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205213', 'cui_str': 'Low frequency'}]","[{'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C3472647', 'cui_str': 'Western Ontario and McMaster Universities osteoarthritis index'}, {'cui': 'C0187769', 'cui_str': 'Operative procedure on knee'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C3539083', 'cui_str': 'Acceptable'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1301808', 'cui_str': 'State'}]",283.0,0.040187,Spa-rehab therapy was not inferior to standard spa therapy for the composite MCII at 3 months or the PASS at 3 and 6 months.,"[{'ForeName': 'Anne-Christine', 'Initials': 'AC', 'LastName': 'Rat', 'Affiliation': 'EA 4360 APEMAC, Université de Lorraine, 54500, Nancy, France. rat-ac@chu-caen.fr.'}, {'ForeName': 'Damien', 'Initials': 'D', 'LastName': 'Loeuille', 'Affiliation': 'Department of Rheumatology, Nancy University Hospital, 54511, Vandoeuvre-les-Nancy, France.'}, {'ForeName': 'Amandine', 'Initials': 'A', 'LastName': 'Vallata', 'Affiliation': 'EA 4360 APEMAC, Université de Lorraine, 54500, Nancy, France.'}, {'ForeName': 'Lorraine', 'Initials': 'L', 'LastName': 'Bernard', 'Affiliation': 'Inserm CIC-EC 1433, Nancy, France.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Spitz', 'Affiliation': 'Department of Rheumatology, Nancy University Hospital, 54511, Vandoeuvre-les-Nancy, France.'}, {'ForeName': 'Alexandra', 'Initials': 'A', 'LastName': 'Desvignes', 'Affiliation': 'Department of Rheumatology, Nancy University Hospital, 54511, Vandoeuvre-les-Nancy, France.'}, {'ForeName': 'Michel', 'Initials': 'M', 'LastName': 'Boulange', 'Affiliation': 'Université de Lorraine, Nancy, France.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Paysant', 'Affiliation': 'Regional Institute for Physical and Rehabilitation Medicine-Louis Pierquin Center of Nancy, 54500, Nancy, France.'}, {'ForeName': 'Francis', 'Initials': 'F', 'LastName': 'Guillemin', 'Affiliation': 'EA 4360 APEMAC, Université de Lorraine, 54500, Nancy, France.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Chary-Valckenaere', 'Affiliation': 'Department of Rheumatology, Nancy University Hospital, 54511, Vandoeuvre-les-Nancy, France.'}]",Scientific reports,['10.1038/s41598-020-67436-1'] 2899,30414356,Comparison of Electrocardiographic Biomarkers for Differentiating Drug-Induced Single vs. Multiple Cardiac Ion Channel Block.,"Since introduction of the International Conference on Harmonization proarrhythmia guidelines in 2005, no new marketed drugs have been associated with unacceptable risk of Torsade de Pointes. Although cardiac safety improved, these guidelines had the unintended consequence of eliminating potentially beneficial drugs from pipelines early in development. More recently, it has been shown that a corrected QT (QTc) prolonging drug may be safe if it impacts multiple ion channels vs. only human ether-a-go-go related gene (hERG) and that this effect can be discriminated using QT subintervals. We compared the predictive power of four electrocardiogram (ECG) repolarization metrics to discriminate single vs. multichannel block: (i) traditional 10-second signal averaged triplicates, and (ii) three metrics that used increasing density of automatically measured beat-to-beat (btb) intervals. Predictive power was evaluated using logistic regression and quantified with receiver operating characteristic (ROC) area under the curve (AUC). Compared with the traditional 10-second signal averaged triplicates, the reduction in classification error ranged from 2-6 with increasing density of btb measurements.",2019,"Compared with the traditional 10-second signal averaged triplicates, the reduction in classification error ranged from 2-6 with increasing density of btb measurements.",[],[],"['predictive power of four electrocardiogram (ECG) repolarization metrics', 'receiver operating characteristic (ROC) area under the curve (AUC']",[],[],"[{'cui': 'C0013798', 'cui_str': 'Electrocardiogram'}, {'cui': 'C0699680', 'cui_str': 'Metric'}, {'cui': 'C0376690', 'cui_str': 'Area under the curve'}]",,0.0234946,"Compared with the traditional 10-second signal averaged triplicates, the reduction in classification error ranged from 2-6 with increasing density of btb measurements.","[{'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Brockway', 'Affiliation': 'VivaQuant, St. Paul, Minnesota, USA.'}, {'ForeName': 'Jay W', 'Initials': 'JW', 'LastName': 'Mason', 'Affiliation': 'Spaulding Clinical Research, West Bend, Wisconsin, USA.'}, {'ForeName': 'Brian P', 'Initials': 'BP', 'LastName': 'Brockway', 'Affiliation': 'VivaQuant, St. Paul, Minnesota, USA.'}]",Clinical and translational science,['10.1111/cts.12596'] 2900,30740895,"Safety, Pharmacokinetics, and Pharmacodynamics of ASP3662, a Novel 11β-Hydroxysteroid Dehydrogenase Type 1 Inhibitor, in Healthy Young and Elderly Subjects.","Inhibition of the enzyme 11β-hydroxysteroid dehydrogenase type 1 (11β-HSD1) represents a potential mechanism for improving pain conditions. ASP3662 is a potent and selective inhibitor of 11β-HSD1. Two phase I clinical studies were conducted to assess the safety, tolerability, pharmacokinetics (PKs), and pharmacodynamics (PDs) of single and multiple ascending doses of ASP3662 in healthy young and elderly non-Japanese and young Japanese subjects. Nonlinear, more than dose-proportional PKs were observed for ASP3662 after single-dose administration, particularly at lower doses (≤ 6 mg); the PKs at steady state were dose proportional, although the time to ASP3662 steady state was dose dependent at lower doses (≤ 2 mg). Similar PKs were observed among young Japanese, young non-Japanese, and elderly non-Japanese subjects. Specific inhibition of 11β-HSD1 occurred after both single and multiple doses of ASP3662. A marked dissociation between PKs and PDs was observed after single but not multiple doses of ASP3662. ASP3662 was generally safe and well tolerated.",2019,Specific inhibition of 11β-HSD1 occurred after both single and multiple doses of ASP3662.,"['Healthy Young and Elderly Subjects', 'healthy young and elderly non-Japanese and young Japanese subjects']","['enzyme 11β-hydroxysteroid dehydrogenase type 1 (11β-HSD1', 'ASP3662']","['Specific inhibition of 11β-HSD1', 'safety, tolerability, pharmacokinetics (PKs), and pharmacodynamics (PDs) of single and multiple ascending doses of ASP3662', 'Safety, Pharmacokinetics, and Pharmacodynamics', 'safe and well tolerated']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}]","[{'cui': 'C0014442', 'cui_str': 'Enzyme'}, {'cui': 'C0020392', 'cui_str': 'Hydroxysteroid Dehydrogenases'}, {'cui': 'C0441729', 'cui_str': 'Type 1'}]","[{'cui': 'C0205369', 'cui_str': 'Specific'}, {'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0205385', 'cui_str': 'Ascending'}]",,0.0135952,Specific inhibition of 11β-HSD1 occurred after both single and multiple doses of ASP3662.,"[{'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Bellaire', 'Affiliation': 'Formerly with Astellas Pharma Europe BV, Leiden, The Netherlands.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Walzer', 'Affiliation': 'Astellas Pharma Global Development, Northbrook, Illinois, USA.'}, {'ForeName': 'Tianli', 'Initials': 'T', 'LastName': 'Wang', 'Affiliation': 'Formerly with Astellas Pharma, Inc., Northbrook, Illinois, USA.'}, {'ForeName': 'Walter', 'Initials': 'W', 'LastName': 'Krauwinkel', 'Affiliation': 'Astellas Pharma, Inc., Leiden, The Netherlands.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Yuan', 'Affiliation': 'Formerly with Astellas Pharma, Inc., Northbrook, Illinois, USA.'}, {'ForeName': 'Gerard J', 'Initials': 'GJ', 'LastName': 'Marek', 'Affiliation': 'Astellas Pharma, Inc., Northbrook, Illinois, USA.'}]",Clinical and translational science,['10.1111/cts.12618'] 2901,31065885,"Willingness to Pay for Cataract Surgeries Among Patients Visiting Eye Care Facilities in Dhaka, Bangladesh.","BACKGROUND Cataract is the leading cause of avoidable blindness globally. It is estimated that 89% of people with visual impairment live in low- and middle-income countries where the cost of cataract surgery represents a major barrier for accessing these services. Developing self-sustaining healthcare programs to cater the unmet demands warrants a better understanding of patients' willingness to pay (WTP) for their services. OBJECTIVES Using a sample of patients visiting eye care facilities in Dhaka, Bangladesh, we estimate WTP for two different cataract extraction techniques, namely small incision cataract surgery (SICS) and phacoemulsification. METHODS We used contingent valuation (CV) approach and elicited WTP through double-bounded dichotomous choice experiments. We interviewed 556 randomly selected patients (283 for SICS and 273 for phacoemulsification) from five different eye care hospitals of Dhaka. In this paper, we estimated the mean and marginal WTP using interval regression models. We also compared the estimated WTP and stated demand for cataract surgeries against the prevailing market prices of SICS and phacoemulsification. RESULTS We found the mean WTP of BDT 7579 (US$93) for SICS and BDT 10,208 (US$126) for phacoemulsification are equivalent to 12 and 16 days of household income, respectively. Household income and assets appeared as the major determinants of WTP for cataract surgeries. However, we did not find any significant association with gender, occupation, and household size among other socioeconomic characteristics. Comparisons between market prices and average WTP suggest it is possible to have a viable market for SICS, but a subsidy-based model for phacoemulsification will be financially challenging because of low WTP and high costs. CONCLUSION Our findings suggest lower-cost SICS can potentially provide patients access to surgeries to treat cataract conditions. Moreover, price discrimination and cross-subsidization could be a viable strategy to increase the service-uptake as well as ensure financial sustainability.",2019,"Developing self-sustaining healthcare programs to cater the unmet demands warrants a better understanding of patients' willingness to pay (WTP) for their services. ","['Cataract Surgeries', 'patients visiting eye care facilities in Dhaka, Bangladesh', '556 randomly selected patients (283 for SICS and 273 for phacoemulsification) from five different eye care hospitals of Dhaka', 'Patients Visiting Eye Care Facilities in Dhaka, Bangladesh']","['contingent valuation (CV) approach and elicited WTP', 'small incision cataract surgery (SICS) and phacoemulsification']",[],"[{'cui': 'C0007389', 'cui_str': 'Extraction of cataract'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0885957', 'cui_str': 'Eye care'}, {'cui': 'C0004732', 'cui_str': 'Bangladesh'}, {'cui': 'C4517811', 'cui_str': '556'}, {'cui': 'C4708786', 'cui_str': '283'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0282545', 'cui_str': 'Phacoemulsification'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C1292724', 'cui_str': 'Procedural approach'}, {'cui': 'C0449265', 'cui_str': 'Elicited by'}, {'cui': 'C0547044', 'cui_str': 'Lesser'}, {'cui': 'C0184898', 'cui_str': 'Incision'}, {'cui': 'C0007389', 'cui_str': 'Extraction of cataract'}, {'cui': 'C0282545', 'cui_str': 'Phacoemulsification'}]",[],556.0,0.0685868,"Developing self-sustaining healthcare programs to cater the unmet demands warrants a better understanding of patients' willingness to pay (WTP) for their services. ","[{'ForeName': 'Muhammed Nazmul', 'Initials': 'MN', 'LastName': 'Islam', 'Affiliation': 'BRAC James P Grant School of Public Health, BRAC University, 68 Shahid Tajuddin Ahmed Avenue, Mohakhali, Dhaka, 1212, Bangladesh. nazmul.islam@bracu.ac.bd.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Engels', 'Affiliation': 'Sightsavers, 35 Perrymount Road, Haywards Health, West Sussex, RH16 3BW, England, UK.'}, {'ForeName': 'Shafayet', 'Initials': 'S', 'LastName': 'Hossain', 'Affiliation': 'BRAC James P Grant School of Public Health, BRAC University, 68 Shahid Tajuddin Ahmed Avenue, Mohakhali, Dhaka, 1212, Bangladesh.'}, {'ForeName': 'Malabika', 'Initials': 'M', 'LastName': 'Sarker', 'Affiliation': 'BRAC James P Grant School of Public Health, BRAC University, 68 Shahid Tajuddin Ahmed Avenue, Mohakhali, Dhaka, 1212, Bangladesh.'}, {'ForeName': 'Atonu', 'Initials': 'A', 'LastName': 'Rabbani', 'Affiliation': 'BRAC James P Grant School of Public Health, BRAC University, 68 Shahid Tajuddin Ahmed Avenue, Mohakhali, Dhaka, 1212, Bangladesh.'}]",Applied health economics and health policy,['10.1007/s40258-019-00478-3'] 2902,31451579,GABAergic Inhibition Gates Perceptual Awareness During Binocular Rivalry.,"Binocular rivalry is a classic experimental tool to probe the neural machinery of perceptual awareness. During rivalry, perception alternates between the two eyes, and the ebb and flow of perception is modeled to rely on the strength of inhibitory interactions between competitive neuronal populations in visual cortex. As a result, rivalry has been suggested as a noninvasive perceptual marker of inhibitory signaling in visual cortex, and its putative disturbance in psychiatric conditions, including autism. Yet, direct evidence causally implicating inhibitory signaling in the dynamics of binocular rivalry is currently lacking. We previously found that people with higher GABA levels in visual cortex, measured using magnetic resonance spectroscopy, have stronger perceptual suppression during rivalry. Here, we present direct causal tests of the impact of GABAergic inhibition on rivalry dynamics, and the contribution of specific GABA receptors to these dynamics. In a crossover pharmacological design with male and female adult participants, we found that drugs that modulate the two dominant GABA receptor types in the brain, GABA A (clobazam) and GABA B (arbaclofen), increase perceptual suppression during rivalry relative to a placebo. Crucially, these results could not be explained by changes in reaction times or response criteria, as determined through rivalry simulation trials, suggesting a direct and specific influence of GABA on perceptual suppression. A full replication study of the GABA B modulator reinforces these findings. These results provide causal evidence for a link between the strength of inhibition in the brain and perceptual suppression during rivalry and have implications for psychiatric conditions including autism. SIGNIFICANCE STATEMENT How does the brain accomplish perceptual gating? Here we use a direct and causal pharmacological manipulation to present insight into the neural machinery of a classic illusion of perceptual awareness: binocular rivalry. We show that drugs that increase GABAergic inhibition in the brain, clobazam (GABA A modulator) and arbaclofen (GABA B modulator), increase perceptual suppression during rivalry relative to a placebo. These results present the first causal link between GABAergic inhibition and binocular rivalry in humans, complementing classic models of binocular rivalry, and have implications for our understanding of psychiatric conditions, such as autism, where binocular rivalry is posited as a behavioral marker of disruptions in inhibitory signaling in the brain.",2019,"Crucially, these results could not be explained by changes in reaction times or response criteria, as determined through rivalry simulation trials, suggesting a direct and specific influence of GABA on perceptual suppression.",['male and female adult participants'],"['placebo', 'GABA A (clobazam) and GABA B (arbaclofen']",['GABAergic inhibition'],"[{'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0016904', 'cui_str': 'Gamma-aminobutyric acid'}]","[{'cui': 'C0021467', 'cui_str': 'Psychological Inhibition'}]",2.0,0.0322306,"Crucially, these results could not be explained by changes in reaction times or response criteria, as determined through rivalry simulation trials, suggesting a direct and specific influence of GABA on perceptual suppression.","[{'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Mentch', 'Affiliation': 'Department of Psychological and Brain Sciences, Dartmouth College, Hanover, New Hampshire 03755.'}, {'ForeName': 'Alina', 'Initials': 'A', 'LastName': 'Spiegel', 'Affiliation': 'School of Medicine, Johns Hopkins University, Baltimore, Maryland, 21205, and.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Ricciardi', 'Affiliation': 'Clinical Research Center, Massachusetts Institute of Technology, Cambridge, Massachusetts 02139.'}, {'ForeName': 'Caroline E', 'Initials': 'CE', 'LastName': 'Robertson', 'Affiliation': 'Department of Psychological and Brain Sciences, Dartmouth College, Hanover, New Hampshire 03755, caroline.e.robertson@dartmouth.edu.'}]",The Journal of neuroscience : the official journal of the Society for Neuroscience,['10.1523/JNEUROSCI.0836-19.2019'] 2903,31496390,"Manipulating the decision making process: Influencing a ""gut"" reaction.","The present series of studies sought to examine how external factors influence behavioral decision making task performance. Utilizing the Iowa Gambling Task (IGT) to assess risky decision making, we examined the influence of a dual task paradigm (Study 1, Study 2), shifting task focus to decision making speed versus accuracy (Study 3), and varied intertrial intervals (Study 4). College student participants completed the IGT and decision making speed and the patterns of IGT selections by deck in the earlier (decision making under ambiguity) and later (decision making under risk) trials were examined. Participants completing the IGT while simultaneously completing a dual working memory task made slower decisions and failed to learn, compared to the single task participants, that Deck C was an advantageous deck. Participants told to focus on being as accurate as possible in their decisions selected more from Deck C, whereas participants told to focus on making the quickest possible decision selected more from Deck D. Manipulating the intertrial interval, giving participants more time to learn from feedback, did not affect decision making speed or accuracy. Implications for our understanding of how individuals decide on the IGT and how heuristics may develop are presented.",2019,"Participants completing the IGT while simultaneously completing a dual working memory task made slower decisions and failed to learn, compared to the single task participants, that Deck C was an advantageous deck.",['College student participants'],['Iowa Gambling Task (IGT'],[],"[{'cui': 'C0557806', 'cui_str': 'College'}, {'cui': 'C0038492', 'cui_str': 'Student'}]","[{'cui': 'C0022037', 'cui_str': 'Iowa'}, {'cui': 'C0016995', 'cui_str': 'Gambling'}]",[],,0.0126592,"Participants completing the IGT while simultaneously completing a dual working memory task made slower decisions and failed to learn, compared to the single task participants, that Deck C was an advantageous deck.","[{'ForeName': 'Melissa T', 'Initials': 'MT', 'LastName': 'Buelow', 'Affiliation': 'Department of Psychology, The Ohio State University , Newark , OH , USA.'}, {'ForeName': 'Melissa K', 'Initials': 'MK', 'LastName': 'Jungers', 'Affiliation': 'Department of Psychology, The Ohio State University , Newark , OH , USA.'}, {'ForeName': 'Krysten R', 'Initials': 'KR', 'LastName': 'Chadwick', 'Affiliation': 'Department of Psychology, The Ohio State University , Newark , OH , USA.'}]",Journal of clinical and experimental neuropsychology,['10.1080/13803395.2019.1662374'] 2904,32618242,Assessment of the Acceptability of Testing and Treatment during a Mass Drug Administration Trial for Malaria in Zambia Using Mixed Methods.,"From 2014 to 2016, a community-randomized controlled trial in Southern Province, Zambia, compared mass drug administration (MDA) and focal MDA (fMDA) with the standard of care. Acceptability of the intervention was assessed quantitatively using closed-ended and Likert scale-based questions posed during three household surveys conducted from April to May in 2014, 2015, and 2016 in 40 health catchments that implemented MDA and fMDA and 20 catchments that served as trial controls. In 2014 and 2015, 47 households per catchment were selected, targeting 1,880 households in MDA and fMDA trial arms; in 2016, 55 households per catchment were selected for a target of 2,200 households in MDA and fMDA trial arms. Concurrently, 27 focus group discussions and 23 in-depth interviews with 248 participants were conducted on reasons for testing and treatment refusal, reasons for nonadherence, and community perception of the MDA campaign. Results demonstrated that the MDA campaign was highly accepted with more than 99% of respondents stating that they would take treatment if positive for malaria. High acceptability at baseline could be associated with test-and-treat campaigns recently conducted in the study area. There was a large increase in the acceptability of prophylactic treatment if negative for malaria from the baseline to follow-up survey for adults and children, from 62% to 96% for each. This likely resulted from an intensive community-wide sensitization program that occurred before the first treatment round at each household during community health worker visits.",2020,"There was a large increase in the acceptability of prophylactic treatment if negative for malaria from the baseline to follow-up survey for adults and children, from 62% to 96% for each.","['2014, 2015, and 2016 in 40 health catchments that implemented MDA and fMDA and 20 catchments that served as trial controls', 'In 2014 and 2015, 47 households per catchment were selected, targeting 1,880 households in MDA and fMDA trial arms; in 2016, 55 households per catchment were selected for a target of 2,200 households in MDA and fMDA trial arms', 'Malaria in Zambia Using Mixed Methods', 'From 2014 to 2016, a community-randomized controlled trial in Southern Province, Zambia, compared mass drug administration (MDA) and focal MDA (fMDA) with the standard of care']",[],[],"[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C4520547', 'cui_str': 'Implemented'}, {'cui': 'C4505223', 'cui_str': 'Mass Administration'}, {'cui': 'C0205234', 'cui_str': 'Focal'}, {'cui': 'C0000379', 'cui_str': 'Methylenedioxyamphetamine'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0024530', 'cui_str': 'Malaria'}, {'cui': 'C0043445', 'cui_str': 'Zambia'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C2936643', 'cui_str': 'Standards of Care'}]",[],[],248.0,0.0973838,"There was a large increase in the acceptability of prophylactic treatment if negative for malaria from the baseline to follow-up survey for adults and children, from 62% to 96% for each.","[{'ForeName': 'Kafula', 'Initials': 'K', 'LastName': 'Silumbe', 'Affiliation': 'PATH Malaria Control and Elimination Partnership in Africa (MACEPA), Lusaka, Zambia.'}, {'ForeName': 'Timothy P', 'Initials': 'TP', 'LastName': 'Finn', 'Affiliation': 'Department of Tropical Medicine, Center for Applied Malaria Research and Evaluation, Tulane University School of Public Health and Tropical Medicine, New Orleans, Louisiana.'}, {'ForeName': 'Todd', 'Initials': 'T', 'LastName': 'Jennings', 'Affiliation': 'PATH Malaria Control and Elimination Partnership in Africa (MACEPA), Lusaka, Zambia.'}, {'ForeName': 'Chilumba', 'Initials': 'C', 'LastName': 'Sikombe', 'Affiliation': 'PATH Malaria Control and Elimination Partnership in Africa (MACEPA), Lusaka, Zambia.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Chiyende', 'Affiliation': 'PATH Malaria Control and Elimination Partnership in Africa (MACEPA), Lusaka, Zambia.'}, {'ForeName': 'Busiku', 'Initials': 'B', 'LastName': 'Hamainza', 'Affiliation': 'National Malaria Elimination Centre, Zambia Ministry of Health, Lusaka, Zambia.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Chizema Kawesha', 'Affiliation': 'National Malaria Elimination Centre, Zambia Ministry of Health, Lusaka, Zambia.'}, {'ForeName': 'Thomas P', 'Initials': 'TP', 'LastName': 'Eisele', 'Affiliation': 'Department of Tropical Medicine, Center for Applied Malaria Research and Evaluation, Tulane University School of Public Health and Tropical Medicine, New Orleans, Louisiana.'}, {'ForeName': 'Duncan', 'Initials': 'D', 'LastName': 'Earle', 'Affiliation': 'PATH Malaria Control and Elimination Partnership in Africa (MACEPA), Lusaka, Zambia.'}, {'ForeName': 'Richard W', 'Initials': 'RW', 'LastName': 'Steketee', 'Affiliation': 'PATH Malaria Control and Elimination Partnership in Africa (MACEPA), Lusaka, Zambia.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Miller', 'Affiliation': 'PATH Malaria Control and Elimination Partnership in Africa (MACEPA), Lusaka, Zambia.'}]",The American journal of tropical medicine and hygiene,['10.4269/ajtmh.19-0663'] 2905,32618245,"A Longitudinal Cohort to Monitor Malaria Infection Incidence during Mass Drug Administration in Southern Province, Zambia.","Rigorous evidence of effectiveness is needed to determine where and when to apply mass drug administration (MDA) or focal MDA (fMDA) as part of a malaria elimination strategy. The Zambia National Malaria Elimination Centre recently completed a community-randomized controlled trial in Southern Province to evaluate MDA and fMDA for transmission reduction. To assess the role of MDA and fMDA on infection incidence, we enrolled a longitudinal cohort for an 18-month period of data collection including monthly malaria parasite infection detection based on polymerase chain reaction and compared time to first infection and cumulative infection incidence outcomes across study arms using Cox proportional hazards and negative binomial models. A total of 2,026 individuals from 733 households were enrolled and completed sufficient follow-up for inclusion in analysis. Infection incidence declined dramatically across all study arms during the period of study, and MDA was associated with reduced risk of first infection (hazards ratio: 0.36; 95% CI: 0.16-0.80) and cumulative infection incidence during the first rainy season (first 5 months of follow-up) (incidence rate ratio: 0.34; 95% CI: 0.12-0.95). No significant effect was found for fMDA or for either arm over the full study period. Polymerase chain reaction infection status at baseline was strongly associated with follow-up infection. The short-term effects of MDA suggest it may be an impactful accelerator of transmission reduction in areas with high coverage of case management and vector control and should be considered as part of a malaria elimination strategy.",2020,The short-term effects of MDA suggest it may be an impactful accelerator of transmission reduction in areas with high coverage of case management and vector control and should be considered as part of a malaria elimination strategy.,"['Southern Province, Zambia', '2,026 individuals from 733 households were enrolled and completed sufficient follow-up for inclusion in analysis']","['MDA', 'MDA and fMDA']","['Infection incidence', 'cumulative infection incidence', 'Polymerase chain reaction infection status', 'reduced risk of first infection']","[{'cui': 'C0043445', 'cui_str': 'Zambia'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0205410', 'cui_str': 'Sufficient'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}]","[{'cui': 'C4505223', 'cui_str': 'Mass Administration'}, {'cui': 'C0205234', 'cui_str': 'Focal'}, {'cui': 'C0000379', 'cui_str': 'Methylenedioxyamphetamine'}]","[{'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0032520', 'cui_str': 'Polymerase chain reaction'}, {'cui': 'C0517627', 'cui_str': 'Infection status'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}]",2026.0,0.0828922,The short-term effects of MDA suggest it may be an impactful accelerator of transmission reduction in areas with high coverage of case management and vector control and should be considered as part of a malaria elimination strategy.,"[{'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Bennett', 'Affiliation': 'Malaria Elimination Initiative, Global Health Group, University of California San Francisco, San Francisco, California.'}, {'ForeName': 'Travis R', 'Initials': 'TR', 'LastName': 'Porter', 'Affiliation': 'Department of Tropical Medicine, Center for Applied Malaria Research and Evaluation, Tulane University School of Public Health and Tropical Medicine, New Orleans, Louisiana.'}, {'ForeName': 'Mulenga C', 'Initials': 'MC', 'LastName': 'Mwenda', 'Affiliation': 'PATH Malaria Control and Elimination Partnership in Africa (MACEPA), Lusaka, Zambia.'}, {'ForeName': 'Joshua O', 'Initials': 'JO', 'LastName': 'Yukich', 'Affiliation': 'Department of Tropical Medicine, Center for Applied Malaria Research and Evaluation, Tulane University School of Public Health and Tropical Medicine, New Orleans, Louisiana.'}, {'ForeName': 'Timothy P', 'Initials': 'TP', 'LastName': 'Finn', 'Affiliation': 'Department of Tropical Medicine, Center for Applied Malaria Research and Evaluation, Tulane University School of Public Health and Tropical Medicine, New Orleans, Louisiana.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Lungu', 'Affiliation': 'PATH Malaria Control and Elimination Partnership in Africa (MACEPA), Lusaka, Zambia.'}, {'ForeName': 'Kafula', 'Initials': 'K', 'LastName': 'Silumbe', 'Affiliation': 'PATH Malaria Control and Elimination Partnership in Africa (MACEPA), Lusaka, Zambia.'}, {'ForeName': 'Brenda', 'Initials': 'B', 'LastName': 'Mambwe', 'Affiliation': 'PATH Malaria Control and Elimination Partnership in Africa (MACEPA), Lusaka, Zambia.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Chishimba', 'Affiliation': 'PATH Malaria Control and Elimination Partnership in Africa (MACEPA), Lusaka, Zambia.'}, {'ForeName': 'Conceptor', 'Initials': 'C', 'LastName': 'Mulube', 'Affiliation': 'PATH Malaria Control and Elimination Partnership in Africa (MACEPA), Lusaka, Zambia.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Bridges', 'Affiliation': 'PATH Malaria Control and Elimination Partnership in Africa (MACEPA), Lusaka, Zambia.'}, {'ForeName': 'Busiku', 'Initials': 'B', 'LastName': 'Hamainza', 'Affiliation': 'National Malaria Elimination Centre, Zambia Ministry of Health, Lusaka, Zambia.'}, {'ForeName': 'Laurence', 'Initials': 'L', 'LastName': 'Slutsker', 'Affiliation': 'PATH MACEPA, Seattle, Washington.'}, {'ForeName': 'Richard W', 'Initials': 'RW', 'LastName': 'Steketee', 'Affiliation': 'PATH MACEPA, Seattle, Washington.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Miller', 'Affiliation': 'PATH Malaria Control and Elimination Partnership in Africa (MACEPA), Lusaka, Zambia.'}, {'ForeName': 'Thomas P', 'Initials': 'TP', 'LastName': 'Eisele', 'Affiliation': 'Department of Tropical Medicine, Center for Applied Malaria Research and Evaluation, Tulane University School of Public Health and Tropical Medicine, New Orleans, Louisiana.'}]",The American journal of tropical medicine and hygiene,['10.4269/ajtmh.19-0657'] 2906,32618247,"Impact of Four Rounds of Mass Drug Administration with Dihydroartemisinin-Piperaquine Implemented in Southern Province, Zambia.","Over the past decade, Zambia has made substantial progress against malaria and has recently set the ambitious goal of eliminating by 2021. In the context of very high vector control and improved access to malaria diagnosis and treatment in Southern Province, we implemented a community-randomized controlled trial to assess the impact of four rounds of community-wide mass drug administration (MDA) and household-level MDA (focal MDA) with dihydroartemisinin-piperaquine (DHAP) implemented between December 2014 and February 2016. The mass treatment campaigns achieved relatively good household coverage (63-79%), were widely accepted by the community (ranging from 87% to 94%), and achieved very high adherence to the DHAP regimen (81-96%). Significant declines in all malaria study end points were observed, irrespective of the exposure group, with the overall parasite prevalence during the peak transmission season declining by 87.2% from 31.3% at baseline to 4.0% in 2016 at the end of the trial. Children in areas of lower transmission (< 10% prevalence at baseline) that received four MDA rounds had a 72% (95% CI = 12-91%) reduction in malaria parasite prevalence as compared with those with the standard of care without any mass treatment. Mass drug administration consistently had the largest short-term effect size across study end points in areas of lower transmission following the first two MDA rounds. In the context of achieving very high vector control coverage and improved access to diagnosis and treatment for malaria, our results suggest that MDA should be considered for implementation in African settings for rapidly reducing malaria outcomes in lower transmission settings.",2020,"Significant declines in all malaria study end points were observed, irrespective of the exposure group, with the overall parasite prevalence during the peak transmission season declining by 87.2% from 31.3% at baseline to 4.0% in 2016 at the end of the trial.","['Southern Province', 'Southern Province, Zambia']","['community-wide mass drug administration (MDA) and household-level MDA (focal MDA) with dihydroartemisinin-piperaquine (DHAP', 'Dihydroartemisinin-Piperaquine', 'MDA']","['malaria parasite prevalence', 'overall parasite prevalence']","[{'cui': 'C0043445', 'cui_str': 'Zambia'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0332464', 'cui_str': 'Widening'}, {'cui': 'C4505223', 'cui_str': 'Mass Administration'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205234', 'cui_str': 'Focal'}, {'cui': 'C0058108', 'cui_str': 'dihydroartemisinin'}, {'cui': 'C0071105', 'cui_str': 'piperaquine'}]","[{'cui': 'C0024530', 'cui_str': 'Malaria'}, {'cui': 'C0030498', 'cui_str': 'Parasite'}, {'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",,0.0868305,"Significant declines in all malaria study end points were observed, irrespective of the exposure group, with the overall parasite prevalence during the peak transmission season declining by 87.2% from 31.3% at baseline to 4.0% in 2016 at the end of the trial.","[{'ForeName': 'Thomas P', 'Initials': 'TP', 'LastName': 'Eisele', 'Affiliation': 'Department of Tropical Medicine, Center for Applied Malaria Research and Evaluation, Tulane University School of Public Health and Tropical Medicine, New Orleans, Louisiana.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Bennett', 'Affiliation': 'Malaria Elimination Initiative, Global Health Group, University of California San Francisco, San Francisco, California.'}, {'ForeName': 'Kafula', 'Initials': 'K', 'LastName': 'Silumbe', 'Affiliation': 'PATH Malaria Control and Elimination Partnership in Africa (MACEPA), Lusaka, Zambia.'}, {'ForeName': 'Timothy P', 'Initials': 'TP', 'LastName': 'Finn', 'Affiliation': 'Department of Tropical Medicine, Center for Applied Malaria Research and Evaluation, Tulane University School of Public Health and Tropical Medicine, New Orleans, Louisiana.'}, {'ForeName': 'Travis R', 'Initials': 'TR', 'LastName': 'Porter', 'Affiliation': 'Department of Tropical Medicine, Center for Applied Malaria Research and Evaluation, Tulane University School of Public Health and Tropical Medicine, New Orleans, Louisiana.'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Chalwe', 'Affiliation': 'Institute for Medical Research and Training, University Teaching Hospital, Lusaka, Zambia.'}, {'ForeName': 'Busiku', 'Initials': 'B', 'LastName': 'Hamainza', 'Affiliation': 'National Malaria Elimination Centre, Zambia Ministry of Health, Lusaka, Zambia.'}, {'ForeName': 'Hawela', 'Initials': 'H', 'LastName': 'Moonga', 'Affiliation': 'National Malaria Elimination Centre, Zambia Ministry of Health, Lusaka, Zambia.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Kooma', 'Affiliation': 'National Malaria Elimination Centre, Zambia Ministry of Health, Lusaka, Zambia.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Chizema Kawesha', 'Affiliation': 'National Malaria Elimination Centre, Zambia Ministry of Health, Lusaka, Zambia.'}, {'ForeName': 'Mulakwa', 'Initials': 'M', 'LastName': 'Kamuliwo', 'Affiliation': 'Zambia Ministry of Health, Southern Provincial Health Office, Choma, Zambia.'}, {'ForeName': 'Joshua O', 'Initials': 'JO', 'LastName': 'Yukich', 'Affiliation': 'Department of Tropical Medicine, Center for Applied Malaria Research and Evaluation, Tulane University School of Public Health and Tropical Medicine, New Orleans, Louisiana.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Keating', 'Affiliation': 'Department of Tropical Medicine, Center for Applied Malaria Research and Evaluation, Tulane University School of Public Health and Tropical Medicine, New Orleans, Louisiana.'}, {'ForeName': 'Kammerle', 'Initials': 'K', 'LastName': 'Schneider', 'Affiliation': 'PATH MACEPA, Seattle, Washington.'}, {'ForeName': 'Ruben O', 'Initials': 'RO', 'LastName': 'Conner', 'Affiliation': 'PATH MACEPA, Seattle, Washington.'}, {'ForeName': 'Duncan', 'Initials': 'D', 'LastName': 'Earle', 'Affiliation': 'PATH Malaria Control and Elimination Partnership in Africa (MACEPA), Lusaka, Zambia.'}, {'ForeName': 'Laurence', 'Initials': 'L', 'LastName': 'Slutsker', 'Affiliation': 'PATH MACEPA, Seattle, Washington.'}, {'ForeName': 'Richard W', 'Initials': 'RW', 'LastName': 'Steketee', 'Affiliation': 'PATH MACEPA, Seattle, Washington.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Miller', 'Affiliation': 'PATH Malaria Control and Elimination Partnership in Africa (MACEPA), Lusaka, Zambia.'}]",The American journal of tropical medicine and hygiene,['10.4269/ajtmh.19-0659'] 2907,32618249,"Cost-Effectiveness of Focal Mass Drug Administration and Mass Drug Administration with Dihydroartemisinin-Piperaquine for Malaria Prevention in Southern Province, Zambia: Results of a Community-Randomized Controlled Trial.","Community-wide administration of antimalarial drugs in therapeutic doses is a potential tool to prevent malaria infection and reduce the malaria parasite reservoir. To measure the effectiveness and cost of using the antimalarial drug combination dihydroartemisinin-piperaquine (DHAp) through different community-wide distribution strategies, Zambia's National Malaria Control Centre conducted a three-armed community-randomized controlled trial. The trial arms were as follows: 1) standard of care (SoC) malaria interventions, 2) SoC plus focal mass drug administration (fMDA), and 3) SoC plus MDA. Mass drug administration consisted of offering all eligible individuals DHAP, irrespective of a rapid diagnostic test (RDT) result. Focal mass drug administration consisted of offering DHAP to all eligible individuals who resided in a household where anyone tested positive by RDT. Results indicate that the costs of fMDA and MDA per person targeted and reached are similar (US$9.01 versus US$8.49 per person, respectively, P = 0.87), but that MDA was superior in all cost-effectiveness measures, including cost per infection averted, cost per case averted, cost per death averted, and cost per disability-adjusted life year averted. Subsequent costing of the MDA intervention in a non-trial, operational setting yielded significantly lower costs per person reached (US$2.90). Mass drug administration with DHAp also met the WHO thresholds for ""cost-effective interventions"" in the Zambian setting in 90% of simulations conducted using a probabilistic sensitivity analysis based on trial costs, whereas fMDA met these criteria in approximately 50% of simulations. A sensitivity analysis using costs from operational deployment and trial effectiveness yielded improved cost-effectiveness estimates. Mass drug administration may be a cost-effective intervention in the Zambian context and can help reduce the parasite reservoir substantially. Mass drug administration was more cost-effective in relatively higher transmission settings. In all scenarios examined, the cost-effectiveness of MDA was superior to that of fMDA.",2020,"Mass drug administration with DHAp also met the WHO thresholds for ""cost-effective interventions"" in the Zambian setting in 90% of simulations conducted using a probabilistic sensitivity analysis based on trial costs, whereas fMDA met these criteria in approximately 50% of simulations.","['Southern Province, Zambia', 'eligible individuals who resided in a household where anyone tested positive by RDT']","['SoC plus focal mass drug administration (fMDA), and 3) SoC plus MDA', 'MDA intervention', 'Focal Mass Drug Administration and Mass Drug Administration with Dihydroartemisinin-Piperaquine', 'antimalarial drug combination dihydroartemisinin-piperaquine (DHAp']","['costs of fMDA and MDA', 'cost-effectiveness of MDA', 'cost-effectiveness estimates', 'cost per infection averted, cost per case averted, cost per death averted, and cost per disability-adjusted life year averted']","[{'cui': 'C0043445', 'cui_str': 'Zambia'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0206743', 'cui_str': 'Malignant rhabdoid tumor'}]","[{'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0205234', 'cui_str': 'Focal'}, {'cui': 'C4505223', 'cui_str': 'Mass Administration'}, {'cui': 'C0000379', 'cui_str': 'Methylenedioxyamphetamine'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0058108', 'cui_str': 'dihydroartemisinin'}, {'cui': 'C0071105', 'cui_str': 'piperaquine'}, {'cui': 'C0003374', 'cui_str': 'Antimalarial'}, {'cui': 'C0012324', 'cui_str': 'Dihydroxyacetone 3-Phosphate'}]","[{'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0016052', 'cui_str': 'Fibromuscular dysplasia'}, {'cui': 'C0000379', 'cui_str': 'Methylenedioxyamphetamine'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0868928', 'cui_str': 'Case'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0456081', 'cui_str': 'Adjustment - action'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0439234', 'cui_str': 'year'}]",,0.139118,"Mass drug administration with DHAp also met the WHO thresholds for ""cost-effective interventions"" in the Zambian setting in 90% of simulations conducted using a probabilistic sensitivity analysis based on trial costs, whereas fMDA met these criteria in approximately 50% of simulations.","[{'ForeName': 'Joshua O', 'Initials': 'JO', 'LastName': 'Yukich', 'Affiliation': 'Department of Tropical Medicine, Center for Applied Malaria Research and Evaluation, Tulane University School of Public Health and Tropical Medicine, New Orleans, Louisiana.'}, {'ForeName': 'Callie', 'Initials': 'C', 'LastName': 'Scott', 'Affiliation': 'PATH Malaria Control and Elimination Partnership in Africa (MACEPA), Seattle, Washington.'}, {'ForeName': 'Kafula', 'Initials': 'K', 'LastName': 'Silumbe', 'Affiliation': 'PATH MACEPA, Lusaka, Zambia.'}, {'ForeName': 'Bruce A', 'Initials': 'BA', 'LastName': 'Larson', 'Affiliation': 'Department of Global Health, Boston University School of Public Health, Boston, Massachusetts.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Bennett', 'Affiliation': 'Malaria Elimination Initiative, Global Health Group, University of California San Francisco, San Francisco, California.'}, {'ForeName': 'Timothy P', 'Initials': 'TP', 'LastName': 'Finn', 'Affiliation': 'Department of Tropical Medicine, Center for Applied Malaria Research and Evaluation, Tulane University School of Public Health and Tropical Medicine, New Orleans, Louisiana.'}, {'ForeName': 'Busiku', 'Initials': 'B', 'LastName': 'Hamainza', 'Affiliation': 'National Malaria Control Centre, Zambia Ministry of Health, Lusaka, Zambia.'}, {'ForeName': 'Ruben O', 'Initials': 'RO', 'LastName': 'Conner', 'Affiliation': 'PATH Malaria Control and Elimination Partnership in Africa (MACEPA), Seattle, Washington.'}, {'ForeName': 'Travis R', 'Initials': 'TR', 'LastName': 'Porter', 'Affiliation': 'Department of Tropical Medicine, Center for Applied Malaria Research and Evaluation, Tulane University School of Public Health and Tropical Medicine, New Orleans, Louisiana.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Keating', 'Affiliation': 'Department of Tropical Medicine, Center for Applied Malaria Research and Evaluation, Tulane University School of Public Health and Tropical Medicine, New Orleans, Louisiana.'}, {'ForeName': 'Richard W', 'Initials': 'RW', 'LastName': 'Steketee', 'Affiliation': 'PATH Malaria Control and Elimination Partnership in Africa (MACEPA), Seattle, Washington.'}, {'ForeName': 'Thomas P', 'Initials': 'TP', 'LastName': 'Eisele', 'Affiliation': 'Department of Tropical Medicine, Center for Applied Malaria Research and Evaluation, Tulane University School of Public Health and Tropical Medicine, New Orleans, Louisiana.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Miller', 'Affiliation': 'PATH MACEPA, Lusaka, Zambia.'}]",The American journal of tropical medicine and hygiene,['10.4269/ajtmh.19-0661'] 2908,32618251,"Treatment Coverage Estimation for Mass Drug Administration for Malaria with Dihydroartemisinin-Piperaquine in Southern Province, Zambia.","Mass drug administration (MDA) is currently being considered as an intervention in low-transmission areas to complement existing malaria control and elimination efforts. The effectiveness of any MDA strategy is dependent on achieving high epidemiologic coverage and participant adherence rates. A community-randomized controlled trial was conducted from November 2014 to March 2016 to evaluate the impact of four rounds of MDA or focal MDA (fMDA)-where treatment was given to all eligible household members if anyone in the household had a positive malaria rapid diagnostic test-on malaria outcomes in Southern Province, Zambia (population approximately 300,000). This study examined epidemiologic coverage and program reach using capture-recapture and satellite enumeration methods to estimate the degree to which the trial reached targeted individuals. Overall, it was found that the percentage of households visited by campaign teams ranged from 62.9% (95% CI: 60.0-65.8) to a high of 77.4% (95% CI: 73.8-81.0) across four rounds of treatment. When the maximum number of visited households across all campaign rounds was used as the numerator, program reach for at least one visit would have been 86.4% (95% CI: 80.8-92.0) in MDA and 83.5% (95% CI: 78.0-89.1) in fMDA trial arms. As per the protocol, the trial provided dihydroartemisinin-piperaquine treatment to an average of 58.8% and 13.3% of the estimated population based on capture-recapture in MDA and fMDA, respectively, across the four rounds.",2020,"Overall, it was found that the percentage of households visited by campaign teams ranged from 62.9% (95% CI: 60.0-65.8) to a high of 77.4% (95% CI: 73.8-81.0) across four rounds of treatment.","['Malaria with Dihydroartemisinin-Piperaquine in Southern Province, Zambia', 'eligible household members if anyone in the household had a positive malaria rapid diagnostic test-on malaria outcomes in Southern Province, Zambia (population approximately 300,000']",['MDA or focal MDA (fMDA)-where treatment'],[],"[{'cui': 'C0024530', 'cui_str': 'Malaria'}, {'cui': 'C0058108', 'cui_str': 'dihydroartemisinin'}, {'cui': 'C0071105', 'cui_str': 'piperaquine'}, {'cui': 'C0043445', 'cui_str': 'Zambia'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0680022', 'cui_str': 'Member of'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0430022', 'cui_str': 'Diagnostic procedure'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0332232', 'cui_str': 'Approximate'}]","[{'cui': 'C4505223', 'cui_str': 'Mass Administration'}, {'cui': 'C0205234', 'cui_str': 'Focal'}, {'cui': 'C0000379', 'cui_str': 'Methylenedioxyamphetamine'}, {'cui': 'C0039798', 'cui_str': 'therapy'}]",[],,0.101887,"Overall, it was found that the percentage of households visited by campaign teams ranged from 62.9% (95% CI: 60.0-65.8) to a high of 77.4% (95% CI: 73.8-81.0) across four rounds of treatment.","[{'ForeName': 'Timothy P', 'Initials': 'TP', 'LastName': 'Finn', 'Affiliation': 'Department of Tropical Medicine, Center for Applied Malaria Research and Evaluation, Tulane University School of Public Health and Tropical Medicine, New Orleans, Louisiana.'}, {'ForeName': 'Joshua O', 'Initials': 'JO', 'LastName': 'Yukich', 'Affiliation': 'Department of Tropical Medicine, Center for Applied Malaria Research and Evaluation, Tulane University School of Public Health and Tropical Medicine, New Orleans, Louisiana.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Bennett', 'Affiliation': 'Malaria Elimination Initiative, Global Health Group, University of California San Francisco, San Francisco, California.'}, {'ForeName': 'Travis R', 'Initials': 'TR', 'LastName': 'Porter', 'Affiliation': 'Department of Tropical Medicine, Center for Applied Malaria Research and Evaluation, Tulane University School of Public Health and Tropical Medicine, New Orleans, Louisiana.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Lungu', 'Affiliation': 'PATH Malaria Control and Elimination Partnership in Africa (MACEPA), Lusaka, Zambia.'}, {'ForeName': 'Busiku', 'Initials': 'B', 'LastName': 'Hamainza', 'Affiliation': 'National Malaria Elimination Centre, Zambia Ministry of Health, Chainama Hospital, Lusaka, Zambia.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Chizema Kawesha', 'Affiliation': 'National Malaria Elimination Centre, Zambia Ministry of Health, Chainama Hospital, Lusaka, Zambia.'}, {'ForeName': 'Ruben O', 'Initials': 'RO', 'LastName': 'Conner', 'Affiliation': 'PATH MACEPA, Seattle, Washington.'}, {'ForeName': 'Kafula', 'Initials': 'K', 'LastName': 'Silumbe', 'Affiliation': 'PATH Malaria Control and Elimination Partnership in Africa (MACEPA), Lusaka, Zambia.'}, {'ForeName': 'Richard W', 'Initials': 'RW', 'LastName': 'Steketee', 'Affiliation': 'PATH MACEPA, Seattle, Washington.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Miller', 'Affiliation': 'PATH Malaria Control and Elimination Partnership in Africa (MACEPA), Lusaka, Zambia.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Keating', 'Affiliation': 'Department of Tropical Medicine, Center for Applied Malaria Research and Evaluation, Tulane University School of Public Health and Tropical Medicine, New Orleans, Louisiana.'}, {'ForeName': 'Thomas P', 'Initials': 'TP', 'LastName': 'Eisele', 'Affiliation': 'Department of Tropical Medicine, Center for Applied Malaria Research and Evaluation, Tulane University School of Public Health and Tropical Medicine, New Orleans, Louisiana.'}]",The American journal of tropical medicine and hygiene,['10.4269/ajtmh.19-0665'] 2909,32618258,Impact of Different Strategies for Delivering Supplemental Zinc on Selected Fecal Markers of Environmental Enteric Dysfunction among Young Laotian Children: A Randomized Controlled Trial.,"The objective of this study was to assess the impact of different strategies for delivering supplemental zinc on fecal myeloperoxidase (MPO), neopterin (NEO), and calprotectin (CAL) among young Laotian children. In a double-blind controlled trial, children aged 6-23 months were randomized to receive either daily preventive zinc (PZ) tablets (7 mg/day), daily micronutrient powder (MNP; containing 10 mg zinc and 14 other micronutrients), therapeutic zinc (TZ) supplements for diarrhea treatment (20 mg/day for 10 days), or daily placebo powder and followed for ∼36 weeks. Stool samples were collected at baseline and endline. Fecal MPO, NEO, and CAL concentrations were determined in a randomly selected subsample of 720 children using commercially available ELISA kits. At baseline, the mean age was 14.1 ± 4.9 months and prevalence of stunting was 39%. The endline prevalence of stunting was 43%; there was no overall treatment effect on physical growth in the parent trial. At endline, the mean (95% CI) MPO in the PZ group was 1,590 [1,396; 1,811] ng/mL and did not differ from that in the MNP (1,633 [1,434; 1,859] ng/mL), TZ (1,749 [1,535; 1,992] ng/mL), and control (1,612 [1,415; 1,836] ng/mL) groups ( P = 0.749). Similarly, there was no overall treatment effect on NEO and CAL concentrations ( P = 0.226 and 0.229, respectively). In this population, the provision of PZ or TZ supplements or MNP had no impact on growth or environmental enteric dysfunction (EED) as assessed by fecal MPO, NEO, and CAL. Additional research is needed to better understand the etiology and proposed mechanisms of EED pathogenesis.",2020,"Similarly, there was no overall treatment effect on NEO and CAL concentrations ( P = 0.226 and 0.229, respectively).","['young Laotian children', 'Young Laotian Children', 'children aged 6-23 months']","['daily micronutrient powder (MNP; containing 10 mg zinc and 14 other micronutrients), therapeutic zinc (TZ) supplements for diarrhea treatment', 'placebo powder', 'daily preventive zinc (PZ) tablets', 'TZ', 'PZ or TZ supplements or MNP', 'MNP']","['prevalence of stunting', 'fecal myeloperoxidase (MPO), neopterin (NEO), and calprotectin (CAL', 'physical growth', 'Fecal MPO, NEO, and CAL concentrations', 'growth or environmental enteric dysfunction (EED', 'NEO and CAL concentrations']","[{'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0023033', 'cui_str': 'Lao language'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}]","[{'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0040577', 'cui_str': 'Trace element'}, {'cui': 'C0032861', 'cui_str': 'Powder'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C0043481', 'cui_str': 'Zinc'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0204169', 'cui_str': 'Preventive dental procedure'}, {'cui': 'C0039225', 'cui_str': 'Tablet'}, {'cui': 'C3541396', 'cui_str': 'Zinc'}]","[{'cui': 'C0033105', 'cui_str': 'Prevalence'}, {'cui': 'C0018273', 'cui_str': 'Growth disorder'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0027021', 'cui_str': 'Peroxidase'}, {'cui': 'C0068527', 'cui_str': 'Neopterin'}, {'cui': 'C0950624', 'cui_str': 'Calprotectin'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0014406', 'cui_str': 'Environment'}, {'cui': 'C1304890', 'cui_str': 'Enteral'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}]",720.0,0.568268,"Similarly, there was no overall treatment effect on NEO and CAL concentrations ( P = 0.226 and 0.229, respectively).","[{'ForeName': 'Guy-Marino', 'Initials': 'GM', 'LastName': 'Hinnouho', 'Affiliation': 'Helen Keller International, Washington, District of Columbia.'}, {'ForeName': 'K Ryan', 'Initials': 'KR', 'LastName': 'Wessells', 'Affiliation': 'Department of Nutrition, Institute for Global Nutrition, University of California, Davis, Davis, California.'}, {'ForeName': 'Maxwell A', 'Initials': 'MA', 'LastName': 'Barffour', 'Affiliation': 'Public Health Program, College of Health and Human Services, Missouri State University, Springfield, Missouri.'}, {'ForeName': 'Somphou', 'Initials': 'S', 'LastName': 'Sayasone', 'Affiliation': ""Lao Tropical and Public Health Institute, Vientiane, Lao People's Democratic Republic.""}, {'ForeName': 'Charles D', 'Initials': 'CD', 'LastName': 'Arnold', 'Affiliation': 'Department of Nutrition, Institute for Global Nutrition, University of California, Davis, Davis, California.'}, {'ForeName': 'Sengchanh', 'Initials': 'S', 'LastName': 'Kounnavong', 'Affiliation': ""Lao Tropical and Public Health Institute, Vientiane, Lao People's Democratic Republic.""}, {'ForeName': 'Sonja Y', 'Initials': 'SY', 'LastName': 'Hess', 'Affiliation': 'Department of Nutrition, Institute for Global Nutrition, University of California, Davis, Davis, California.'}]",The American journal of tropical medicine and hygiene,['10.4269/ajtmh.20-0106'] 2910,32618265,"Moving from Malaria Burden Reduction toward Elimination: An Evaluation of Mass Drug Administration in Southern Province, Zambia.","From December 2014 to February 2016, a cluster randomized controlled trial was carried out in 60 health facility catchment areas along Lake Kariba in Zambia's Southern Province. The trial sought to evaluate the impact of four rounds of a mass drug administration (MDA) intervention with dihydroartemisinin-piperaquine (DHAP) or focal MDA with DHAP at the household level compared with a control population that received the standard of care. This study was the first randomized controlled trial with DHAP for MDA in sub-Saharan Africa and was conducted through a collaboration between the National Malaria Elimination Programme in the Zambian Ministry of Health, the PATH Malaria Control and Elimination Partnership in Africa, and the Center for Applied Malaria Research and Evaluation at Tulane University. This article serves as an introduction to a collection of articles designed to explore different aspects of the intervention. By describing the recent history of malaria control in Zambia leading up to the trial-from the scale-up of point-of-care diagnosis and treatment, vector control, and indoor residual spraying early in the twenty-first century, to the efforts made to sustain the gains achieved with that approach-it provides a rationale for the implementation of a trial that has informed a new national strategic plan and solidified malaria elimination as Zambia's national goal.",2020,"By describing the recent history of malaria control in Zambia leading up to the trial-from the scale-up of point-of-care diagnosis and treatment, vector control, and indoor residual spraying early in the twenty-first century, to the efforts made to sustain the gains achieved with that approach-it provides a rationale for the implementation of a trial that has informed a new national strategic plan and solidified malaria elimination as Zambia's national goal.","['sub-Saharan Africa and was conducted through a collaboration between the National Malaria Elimination Programme in the Zambian Ministry of Health, the PATH Malaria Control and Elimination Partnership in Africa, and the Center for Applied Malaria Research and Evaluation at Tulane University', ""60 health facility catchment areas along Lake Kariba in Zambia's Southern Province"", 'Southern Province, Zambia']","['Elimination', 'DHAP', 'mass drug administration (MDA) intervention with dihydroartemisinin-piperaquine (DHAP) or focal MDA with DHAP']",[],"[{'cui': 'C0001738', 'cui_str': 'Sub-Saharan Africa'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0015737', 'cui_str': 'National Government'}, {'cui': 'C0024530', 'cui_str': 'Malaria'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0001737', 'cui_str': 'Africa'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0242481', 'cui_str': 'Research Activities'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0018704', 'cui_str': 'Healthcare facility'}, {'cui': 'C0007403', 'cui_str': 'Health Catchment Area'}, {'cui': 'C0337049', 'cui_str': 'Lake'}, {'cui': 'C0043445', 'cui_str': 'Zambia'}]","[{'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C0058108', 'cui_str': 'dihydroartemisinin'}, {'cui': 'C0071105', 'cui_str': 'piperaquine'}, {'cui': 'C4505223', 'cui_str': 'Mass Administration'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0205234', 'cui_str': 'Focal'}]",[],,0.0505108,"By describing the recent history of malaria control in Zambia leading up to the trial-from the scale-up of point-of-care diagnosis and treatment, vector control, and indoor residual spraying early in the twenty-first century, to the efforts made to sustain the gains achieved with that approach-it provides a rationale for the implementation of a trial that has informed a new national strategic plan and solidified malaria elimination as Zambia's national goal.","[{'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Miller', 'Affiliation': 'PATH Malaria Control and Elimination Partnership in Africa (MACEPA), Lusaka, Zambia.'}, {'ForeName': 'Thomas P', 'Initials': 'TP', 'LastName': 'Eisele', 'Affiliation': 'Department of Tropical Medicine, Center for Applied Malaria Research and Evaluation, Tulane University School of Public Health and Tropical Medicine, New Orleans, Louisiana.'}, {'ForeName': 'Maya S', 'Initials': 'MS', 'LastName': 'Fraser', 'Affiliation': 'PATH MACEPA, Seattle, Washington.'}, {'ForeName': 'Manuel T', 'Initials': 'MT', 'LastName': 'Lewis', 'Affiliation': 'PATH MACEPA, Seattle, Washington.'}, {'ForeName': 'Laurence', 'Initials': 'L', 'LastName': 'Slutsker', 'Affiliation': 'PATH MACEPA, Seattle, Washington.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Chizema Kawesha', 'Affiliation': 'National Malaria Control Centre, Zambia Ministry of Health, Lusaka, Zambia.'}]",The American journal of tropical medicine and hygiene,['10.4269/ajtmh.19-0669'] 2911,32618386,Cardiovascular and renal outcomes by baseline albuminuria status and renal function - results from the LEADER randomized trial.,"AIMS It is important to understand links among urinary albumin-to-creatinine ratio (UACR), estimated glomerular filtration rate (eGFR) and outcomes in contemporary type 2 diabetes (T2D) populations receiving standard treatments. We aimed to assess cardiorenal outcomes by baseline UACR and eGFR in the contemporary LEADER cohort. MATERIALS AND METHODS LEADER was a multinational, double-blind trial. Patients with T2D and high cardiovascular (CV) risk were randomized 1:1 to the glucagon-like peptide-1 analog liraglutide (≤1.8 mg daily; n = 4668) or placebo (n = 4672) plus standard care and followed for 3.5 to 5 years. Primary composite outcome: time to first non-fatal myocardial infarction, non-fatal stroke or CV death. Post hoc Cox regression analyses of outcomes by baseline UACR and eGFR subgroups were conducted with adjustment for baseline variables. RESULTS In the LEADER population 1598 (17.5%), 2917 (31.9%), 1200 (13.1%), 1611 (17.6%), 845 (9.2%) and 966 (10.6%) had UACR =0, >0-<15, 15-<30, 30-<100, 100-<300, ≥300 mg/g respectively. Increasing UACR and decreasing eGFR were linked with higher risks of the primary outcome, heart failure hospitalization, a composite renal outcome and death (P-values for Cochran-Armitage test for trends all <0.0001). Across UACR and eGFR subgroups, risks of cardiorenal events and death were generally lower or similar with liraglutide versus placebo. CONCLUSIONS In a contemporary T2D population, increasing baseline UACR and declining eGFR were linked with higher risks of cardiorenal events and death. ClinicalTrials.gov NCT01179048. This article is protected by copyright. All rights reserved.",2020,"Across UACR and eGFR subgroups, risks of cardiorenal events and death were generally lower or similar with liraglutide versus placebo. ",['Patients with T2D and high cardiovascular (CV) risk'],"['glucagon-like peptide-1 analog liraglutide', 'liraglutide', 'placebo']","['UACR', 'Primary composite outcome: time to first non-fatal myocardial infarction, non-fatal stroke or CV death', 'Cardiovascular and renal outcomes', 'heart failure hospitalization, a composite renal outcome and death', 'urinary albumin-to-creatinine ratio (UACR), estimated glomerular filtration rate (eGFR) and outcomes', 'risks of cardiorenal events and death']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}]","[{'cui': 'C0061355', 'cui_str': 'Glucagon-like peptide 1'}, {'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0001924', 'cui_str': 'albumin'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0205225', 'cui_str': 'Principal'}, {'cui': 'C0205199', 'cui_str': 'Composite'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1302234', 'cui_str': 'Fatal'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0750572', 'cui_str': 'Estimated'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0441471', 'cui_str': 'Event'}]",,0.413189,"Across UACR and eGFR subgroups, risks of cardiorenal events and death were generally lower or similar with liraglutide versus placebo. ","[{'ForeName': 'Ofri', 'Initials': 'O', 'LastName': 'Mosenzon', 'Affiliation': 'Diabetes Unit, Hadassah Hebrew University Hospital, Jerusalem, Israel.'}, {'ForeName': 'Stephen C', 'Initials': 'SC', 'LastName': 'Bain', 'Affiliation': 'Diabetes Research Unit Cymru, Swansea University, Swansea, UK.'}, {'ForeName': 'Hiddo J L', 'Initials': 'HJL', 'LastName': 'Heerspink', 'Affiliation': 'Department of Clinical Pharmacy and Pharmacology, University Medical Center Groningen, Groningen, Netherlands.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Idorn', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Johannes F E', 'Initials': 'JFE', 'LastName': 'Mann', 'Affiliation': 'Dept. of Nephrology, Univ. Hospital, Friedrich Alexander University of Erlangen, Erlangen, Germany.'}, {'ForeName': 'Frederik', 'Initials': 'F', 'LastName': 'Persson', 'Affiliation': 'Steno Diabetes Center Copenhagen, Gentofte, Denmark.'}, {'ForeName': 'Richard E', 'Initials': 'RE', 'LastName': 'Pratley', 'Affiliation': 'AdventHealth Translational Research Institute, Orlando, Florida, USA.'}, {'ForeName': 'Søren', 'Initials': 'S', 'LastName': 'Rasmussen', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Rossing', 'Affiliation': 'Steno Diabetes Center Copenhagen, Gentofte, Denmark.'}, {'ForeName': 'Bernt Johan', 'Initials': 'BJ', 'LastName': 'von Scholten', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Itamar', 'Initials': 'I', 'LastName': 'Raz', 'Affiliation': 'Diabetes Unit, Hadassah Hebrew University Hospital, Jerusalem, Israel.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Diabetes, obesity & metabolism",['10.1111/dom.14126'] 2912,32618395,Video Conference vs Face-to-Face Group Psychotherapy for Distressed Cancer Survivors: A Randomized Controlled Trial.,"OBJECTIVE This study assesses the effectiveness of face-to-face group positive psychotherapy for cancer survivors (PPC) compared to its online adaptation, online group positive psychotherapy for cancer survivors (OPPC), which is held via videoconference. A two-arm, pragmatic RCT was conducted to examine the effects of both interventions on emotional distress, posttraumatic stress (PTSS) and posttraumatic growth (PTG) among cancer survivors and analyze attrition to treatment. METHODS Adult women with a range of cancer diagnoses were invited to participate if they experienced emotional distress at the end of their primary oncological treatment. Emotional distress, PTSS and PTG were assessed at baseline, immediately after treatment and three months after treatment. Intention-to-treat analyses were carried out using general linear mixed models to test the effect of the interventions overtime. Logistic regressions were performed to test differential adherence to treatment and retention to follow-up. RESULTS A total of 269 individuals participated. The observed treatment effect was significant in both modalities, PPC and OPPC. Emotional distress (b = -2.24, 95%CI = -3.15- -1.33) and PTSS (b = -3.25, 95%CI = -4.97- -1.53) decreased significantly over time, and PTG (b = 3.08, 95%CI = 0.38-5.78) increased significantly. Treatment gains were sustained across outcomes and over time. Analyses revealed no significant differences between modalities of treatment, after adjusting for baseline differences, finding that OPPC is as effective and engaging as PPC. CONCLUSIONS The OPPC treatment was found to be effective and engaging for female cancer early survivors. These results open the door for psycho-oncology interventions via videoconference, which are likely to lead to greater accessibility and availability of psychotherapy. This article is protected by copyright. All rights reserved.",2020,"Analyses revealed no significant differences between modalities of treatment, after adjusting for baseline differences, finding that OPPC is as effective and engaging as PPC. ","['female cancer early survivors', 'Adult women with a range of cancer diagnoses were invited to participate if they experienced emotional distress at the end of their primary oncological treatment', '269 individuals participated', 'cancer survivors (PPC', 'Distressed Cancer Survivors', 'cancer survivors (OPPC']","['OPPC', 'Video Conference vs Face-to-Face Group Psychotherapy', 'face-to-face group positive psychotherapy', 'PTSS']","['Emotional distress, PTSS and PTG', 'emotional distress, posttraumatic stress (PTSS) and posttraumatic growth (PTG', 'Emotional distress', 'time, and PTG']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0700361', 'cui_str': 'Emotional distress'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}, {'cui': 'C0033968', 'cui_str': 'Psychotherapy'}, {'cui': 'C3887804', 'cui_str': 'Feeling upset'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1446409', 'cui_str': 'Positive'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0033968', 'cui_str': 'Psychotherapy'}, {'cui': 'C1516231', 'cui_str': 'Cancer Survivors'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0086047', 'cui_str': 'Conferences'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0033971', 'cui_str': 'Group psychotherapy'}, {'cui': 'C0038435', 'cui_str': 'Stress'}]","[{'cui': 'C0700361', 'cui_str': 'Emotional distress'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C4704809', 'cui_str': 'Posttraumatic Growth'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",269.0,0.121219,"Analyses revealed no significant differences between modalities of treatment, after adjusting for baseline differences, finding that OPPC is as effective and engaging as PPC. ","[{'ForeName': 'María', 'Initials': 'M', 'LastName': 'Lleras de Frutos', 'Affiliation': ""Psycho-Oncology Department and ICOnnecta't e-health program, Institut Català d'Oncologia, L'Hospitalet de Llobregat, Barcelona, Spain.""}, {'ForeName': 'Joan Carles', 'Initials': 'JC', 'LastName': 'Medina', 'Affiliation': ""Institut d'Investigació Biomèdica de Bellvitge, L'Hospitalet de Llobregat, Barcelona, Spain.""}, {'ForeName': 'Jaume', 'Initials': 'J', 'LastName': 'Vives', 'Affiliation': 'Department of Psychobiology and Methodology of Health Sciences and Sport Research Institute, Universitat Autònoma de Barcelona, Cerdanyola del Vallès, Barcelona, Spain.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Casellas-Grau', 'Affiliation': ""Psychosocial Observatory in Cancer, Institut Català d'Oncologia. L'Hospitalet de Llobregat, Barcelona, Spain.""}, {'ForeName': 'Jose Luis', 'Initials': 'JL', 'LastName': 'Marzo', 'Affiliation': 'Universitat de Girona, Girona, Spain.'}, {'ForeName': 'Josep M', 'Initials': 'JM', 'LastName': 'Borràs', 'Affiliation': ""Institut d'Investigació Biomèdica de Bellvitge, L'Hospitalet de Llobregat, Barcelona, Spain.""}, {'ForeName': 'Cristian', 'Initials': 'C', 'LastName': 'Ochoa-Arnedo', 'Affiliation': ""Psycho-Oncology Department and ICOnnecta't e-health program, Institut Català d'Oncologia, L'Hospitalet de Llobregat, Barcelona, Spain.""}]",Psycho-oncology,['10.1002/pon.5457'] 2913,32618414,Clinical feasibility and acceptability of adding cognitive behavioral therapy to pharmacotherapy for drug-resistant overactive bladder in women: A single-arm pilot study.,"OBJECTIVES Drug-resistant overactive bladder (OAB) represents an unmet medical need in that treatment options are limited. We developed a treatment model based on cognitive behavioral therapy and evaluated its feasibility and acceptability for drug-resistant OAB in women. METHODS This was an open-label, single-arm, multicenter pilot study. We defined drug-resistant OAB as OAB with moderate to severe symptoms despite pharmacotherapy for more than 12 weeks. A face-to-face intervention was prescribed as six sessions (30 minutes each) over 6 to 12 weeks according to a treatment manual. The effects were assessed by self-reported questionnaires and frequency voiding charts (FVC) at baseline, during intervention, immediately after intervention, and at follow-up. RESULTS Ten patients participated in this study. Median age was 72 years, median OAB Symptom Score was nine points, and median duration of prior treatment for OAB was 5.5 years at baseline. Two participants dropped out of the study. Among the remaining patients, the scores of the OAB Questionnaire subscales improved (effect size: 0.75-1.73), and the mean urinary frequency in the FVC also improved from baseline (9.0 times, SD: 2.1) to follow-up (6.2 times, SD: 1.2). All participants were satisfied with the intervention. There were no adverse events during this study. CONCLUSIONS The new treatment based on cognitive behavioral therapy was well tolerated and feasible in women with drug-resistant OAB. Further randomized research is needed to rigorously evaluate the efficacy of the treatment.",2020,"Among the remaining patients, the scores of the OAB Questionnaire subscales improved (effect size: 0.75-1.73), and the mean urinary frequency in the FVC also improved from baseline (9.0 times, SD: 2.1) to follow-up (6.2 times, SD: 1.2).","['drug-resistant overactive bladder in women', 'women with drug-resistant OAB', 'Ten patients participated in this study', 'women']","['cognitive behavioral therapy', 'cognitive behavioral therapy to pharmacotherapy']","['OAB Questionnaire subscales', 'mean urinary frequency', 'self-reported questionnaires and frequency voiding charts (FVC', 'median OAB Symptom Score', 'adverse events']","[{'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0332325', 'cui_str': 'Resistant'}, {'cui': 'C0878773', 'cui_str': 'Overactive bladder'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0009244', 'cui_str': 'Cognitive therapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0878773', 'cui_str': 'Overactive bladder'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0042023', 'cui_str': 'Increased frequency of urination'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0684240', 'cui_str': 'Chart'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",10.0,0.0303741,"Among the remaining patients, the scores of the OAB Questionnaire subscales improved (effect size: 0.75-1.73), and the mean urinary frequency in the FVC also improved from baseline (9.0 times, SD: 2.1) to follow-up (6.2 times, SD: 1.2).","[{'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Funada', 'Affiliation': 'Department of Urology, Kyoto University Graduate School of Medicine, Kyoto, Japan.'}, {'ForeName': 'Norio', 'Initials': 'N', 'LastName': 'Watanabe', 'Affiliation': 'Department of Health Promotion and Human Behavior, Kyoto University School of Public Health, Kyoto, Japan.'}, {'ForeName': 'Takayuki', 'Initials': 'T', 'LastName': 'Goto', 'Affiliation': 'Department of Urology, Kyoto University Graduate School of Medicine, Kyoto, Japan.'}, {'ForeName': 'Hiromitsu', 'Initials': 'H', 'LastName': 'Negoro', 'Affiliation': 'Department of Urology, University of Tsukuba Hospital, Ibaraki, Japan.'}, {'ForeName': 'Shusuke', 'Initials': 'S', 'LastName': 'Akamatsu', 'Affiliation': 'Department of Urology, Kyoto University Graduate School of Medicine, Kyoto, Japan.'}, {'ForeName': 'Ryuji', 'Initials': 'R', 'LastName': 'Uozumi', 'Affiliation': 'Department of Biomedical Statistics and Bioinformatics, Kyoto University Graduate School of Medicine, Kyoto, Japan.'}, {'ForeName': 'Sanae', 'Initials': 'S', 'LastName': 'Kishimoto', 'Affiliation': 'Department of Health Promotion and Human Behavior, Kyoto University School of Public Health, Kyoto, Japan.'}, {'ForeName': 'Kentaro', 'Initials': 'K', 'LastName': 'Ichioka', 'Affiliation': 'Ichioka Urological Clinic, Kyoto, Japan.'}, {'ForeName': 'Takehiko', 'Initials': 'T', 'LastName': 'Segawa', 'Affiliation': 'Department of Urology, Kyoto City Hospital, Kyoto, Japan.'}, {'ForeName': 'Toshi A', 'Initials': 'TA', 'LastName': 'Furukawa', 'Affiliation': 'Department of Health Promotion and Human Behavior, Kyoto University School of Public Health, Kyoto, Japan.'}, {'ForeName': 'Osamu', 'Initials': 'O', 'LastName': 'Ogawa', 'Affiliation': 'Department of Urology, Kyoto University Graduate School of Medicine, Kyoto, Japan.'}]",Lower urinary tract symptoms,['10.1111/luts.12333'] 2914,32618438,"The Bioequivalence of Two Peficitinib Formulations, and the Effect of Food on the Pharmacokinetics of Peficitinib: Two-Way Crossover Studies of a Single Dose of 150 mg Peficitinib in Healthy Volunteers.","The marketed tablet formulation of peficitinib differs from the tablet used during the clinical trials. The bioequivalence of the marketed formulation and developmental tablet, and the food effect on the marketed formulation, were analyzed in 2 Japanese open-label, randomized, 2-way crossover studies in healthy male volunteers. Volunteers received a single oral dose of the marketed 150-mg peficitinib tablet under fasted conditions (bioequivalence), and under fed or fasted conditions (food effect). Bioequivalence was compared with the developmental 150-mg tablet. Samples for pharmacokinetic analysis were collected before dose and ≤72 hours after dose. Safety assessments included adverse events, vital signs, and laboratory variables. In total, 40 and 18 subjects were randomized to the bioequivalence and food effect studies, respectively. The 2 peficitinib formulations were bioequivalent (90% confidence intervals of the geometric mean ratios for C max and AUC t of peficitinib were within predefined limits of 0.8 to 1.25). The AUC last and the C max of the marketed tablet were 36.8% and 56.4% higher, respectively, under fed versus fasted conditions. Peficitinib was well tolerated. The marketed 150-mg tablet formulation of peficitinib was bioequivalent to the developmental 150-mg formulation, with no discernible safety differences. Bioavailability increased under fed conditions with the marketed tablet formulation.",2020,"The marketed 150-mg tablet formulation of peficitinib was bioequivalent to the developmental 150-mg formulation, with no discernible safety differences.","['Healthy Volunteers', 'healthy male volunteers', 'In total, 40 and 18 subjects']",['Peficitinib'],"['adverse events, vital signs, and laboratory variables', 'Bioavailability', 'tolerated']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0042960', 'cui_str': 'Voluntary worker'}, {'cui': 'C0439810', 'cui_str': 'Total'}]","[{'cui': 'C4505522', 'cui_str': 'peficitinib'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0439828', 'cui_str': 'Variable'}, {'cui': 'C0005508', 'cui_str': 'Availability, Biological'}]",,0.0296822,"The marketed 150-mg tablet formulation of peficitinib was bioequivalent to the developmental 150-mg formulation, with no discernible safety differences.","[{'ForeName': 'Mai', 'Initials': 'M', 'LastName': 'Shibata', 'Affiliation': 'Astellas Pharma Inc., Tokyo, Japan.'}, {'ForeName': 'Junko', 'Initials': 'J', 'LastName': 'Toyoshima', 'Affiliation': 'Astellas Pharma Inc., Tokyo, Japan.'}, {'ForeName': 'Yuichiro', 'Initials': 'Y', 'LastName': 'Kaneko', 'Affiliation': 'Astellas Pharma Inc., Tokyo, Japan.'}, {'ForeName': 'Kazuo', 'Initials': 'K', 'LastName': 'Oda', 'Affiliation': 'Astellas Research Institute of America LLC, Northbrook, Illinois, USA.'}, {'ForeName': 'Tsuyoshi', 'Initials': 'T', 'LastName': 'Kiyota', 'Affiliation': 'Astellas Pharma Inc., Tokyo, Japan.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Kambayashi', 'Affiliation': 'Astellas Pharma Inc., Tokyo, Japan.'}, {'ForeName': 'Tetsuya', 'Initials': 'T', 'LastName': 'Nishimura', 'Affiliation': 'Astellas Pharma Inc., Tokyo, Japan.'}]",Clinical pharmacology in drug development,['10.1002/cpdd.843'] 2915,32618522,Investigating the learning curve in endoscopic compared to microscopic myringotomy and ventilation tube insertion.,"OBJECTIVE Rate of learning is often cited as a deterrent in the use of endoscopic ear surgery. This study investigated the learning curves of novice surgeons performing simulated ear surgery using either an endoscope or a microscope. METHODS A prospective multi-site clinical research study was conducted. Seventy-two medical students were randomly allocated to the endoscope or microscope group, and performed 10 myringotomy and ventilation tube insertions. Trial times were used to produce learning curves. From these, slope (learning rate) and asymptote (optimal proficiency) were ascertained. RESULTS There was no significant difference between the learning curves (p = 0.41). The learning rate value was 68.62 for the microscope group and 78.71 for the endoscope group. The optimal proficiency (seconds) was 32.83 for the microscope group and 27.87 for the endoscope group. CONCLUSION The absence of a significant difference shows that the learning rates of each technique are statistically indistinguishable. This suggests that surgeons are not justified when citing 'steep learning curve' in arguments against the use of endoscopes in middle-ear surgery.",2020,"The optimal proficiency (seconds) was 32.83 for the microscope group and 27.87 for the endoscope group. ",['Seventy-two medical students'],"['microscopic myringotomy and ventilation tube insertion', 'endoscope or microscope group, and performed 10 myringotomy and ventilation tube insertions', 'novice surgeons performing simulated ear surgery using either an endoscope or a microscope']","['learning curves', 'learning rates', 'learning rate value']","[{'cui': 'C4319632', 'cui_str': '72'}, {'cui': 'C0038495', 'cui_str': 'Medical student'}]","[{'cui': 'C0205288', 'cui_str': 'Microscopic'}, {'cui': 'C0087123', 'cui_str': 'Tympanostomy'}, {'cui': 'C0850121', 'cui_str': 'Tympanic ventilation tube'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0014243', 'cui_str': 'Endoscope'}, {'cui': 'C0181839', 'cui_str': 'Microscope'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}, {'cui': 'C0038899', 'cui_str': 'Otologic Surgical Procedure'}]","[{'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0205134', 'cui_str': 'Curved'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",72.0,0.022179,"The optimal proficiency (seconds) was 32.83 for the microscope group and 27.87 for the endoscope group. ","[{'ForeName': 'O', 'Initials': 'O', 'LastName': 'Denton', 'Affiliation': 'Postgraduate Centre, Glasgow Royal Infirmary, NHS Greater Glasgow and Clyde, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Daglish', 'Affiliation': 'Postgraduate Medical Education Centre, Royal Berkshire NHS Foundation Trust, Reading, UK.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Smallman', 'Affiliation': 'School of Mathematics, Cardiff University, Wales, UK.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Fishpool', 'Affiliation': 'Department of ENT, Cwm Taf Morgannwg University Health Board, Ynysmaerdy, Wales, UK.'}]",The Journal of laryngology and otology,['10.1017/S0022215120001188'] 2916,32618626,The Effect of High-Flow Nasal Oxygen on Carbon Dioxide Accumulation in Apneic or Spontaneously Breathing Adults During Airway Surgery: A Randomized-Controlled Trial.,"BACKGROUND High-flow nasal oxygen (HFNO) is an emerging technology that has generated interest in tubeless anesthesia for airway surgery. HFNO has been shown to maintain oxygenation and CO2 clearance in spontaneously breathing patients and is an effective approach to apneic oxygenation. Although it has been suggested that HFNO can enhance CO2 clearance during apnea, this has not been established. The true extent of CO2 accumulation and resulting acidosis using HFNO during prolonged tubeless anesthesia remains undefined. METHODS In a single-center trial, we randomly assigned 20 adults undergoing microlaryngoscopy to apnea or spontaneous ventilation (SV) using HFNO during 30 minutes of tubeless anesthesia. Serial arterial blood gas analysis was performed during preoxygenation and general anesthesia. The primary outcome was the partial pressure of CO2 (PaCO2) after 30 minutes of general anesthesia, with each group compared using a Student t test. RESULTS Nineteen patients completed the study protocol (9 in the SV group and 10 in the apnea group). The mean (standard deviation [SD]) PaCO2 was 89.0 mm Hg (16.5 mm Hg) in the apnea group and 55.2 mm Hg (7.2 mm Hg) in the SV group (difference in means, 33.8; 95% confidence interval [CI], 20.6-47.0) after 30 minutes of general anesthesia (P < .001). The average rate of PaCO2 rise during 30 minutes of general anesthesia was 1.8 mm Hg/min (SD = 0.5 mm Hg/min) in the apnea group and 0.8 mm Hg/min (SD = 0.3 mm Hg/min) in the SV group. The mean (SD) pH was 7.11 (0.04) in the apnea group and 7.29 (0.06) in the SV group (P < .001) at 30 minutes. Five (55%) of the apneic patients had a pH <7.10, of which the lowest measurement was 7.057. No significant difference in partial pressure of arterial O2 (PaO2) was observed after 30 minutes of general anesthesia. CONCLUSIONS CO2 accumulation during apnea was more than double that of SV after 30 minutes of tubeless anesthesia using HFNO. The use of robust measurement confirms that apnea with HFNO is limited by CO2 accumulation and the concomitant severe respiratory acidosis, in contrast to SV. This extends previous knowledge and has implications for the safe application of HFNO during prolonged procedures.",2020,"No significant difference in partial pressure of arterial O2 (PaO2) was observed after 30 minutes of general anesthesia. ","['Nineteen patients completed the study protocol (9 in the SV group and 10 in the apnea group', '20 adults undergoing', 'Apneic or Spontaneously Breathing Adults']","['HFNO', 'High-Flow Nasal Oxygen', 'High-flow nasal oxygen (HFNO', 'microlaryngoscopy to apnea or spontaneous ventilation (SV) using HFNO during 30 minutes of tubeless anesthesia']","['partial pressure of arterial O2 (PaO2', 'Carbon Dioxide Accumulation', 'average rate of PaCO2 rise', 'CO2 clearance', 'partial pressure of CO2 (PaCO2', 'mean (standard deviation [SD]) PaCO2', 'mean (SD) pH']","[{'cui': 'C0450337', 'cui_str': '19'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C2599718', 'cui_str': 'Clinical Trial Protocols'}, {'cui': 'C0412771', 'cui_str': 'Spontaneous respiration'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0003578', 'cui_str': 'Apnea'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0004048', 'cui_str': 'Inhaling'}]","[{'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0456202', 'cui_str': 'Microlaryngoscopy'}, {'cui': 'C0003578', 'cui_str': 'Apnea'}, {'cui': 'C0412771', 'cui_str': 'Spontaneous respiration'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}]","[{'cui': 'C0030604', 'cui_str': 'Partial pressure'}, {'cui': 'C0003842', 'cui_str': 'Arterial structure'}, {'cui': 'C0033095', 'cui_str': 'Pressure - physical agent'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}]",20.0,0.174393,"No significant difference in partial pressure of arterial O2 (PaO2) was observed after 30 minutes of general anesthesia. ","[{'ForeName': 'Anton W G', 'Initials': 'AWG', 'LastName': 'Booth', 'Affiliation': 'From the Department of Anaesthesia, Princess Alexandra Hospital-Southern Clinical School, Faculty of Medicine, The University of Queensland, Brisbane, Australia.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Vidhani', 'Affiliation': 'From the Department of Anaesthesia, Princess Alexandra Hospital-Southern Clinical School, Faculty of Medicine, The University of Queensland, Brisbane, Australia.'}, {'ForeName': 'Phil K', 'Initials': 'PK', 'LastName': 'Lee', 'Affiliation': 'Department of Anaesthesia, Princess Alexandra Hospital, Brisbane, Australia.'}, {'ForeName': 'Scott H', 'Initials': 'SH', 'LastName': 'Coman', 'Affiliation': 'Department of Otolaryngology-Head and Neck Surgery, Princess Alexandra Hospital, Brisbane, Australia.'}, {'ForeName': 'Anita M', 'Initials': 'AM', 'LastName': 'Pelecanos', 'Affiliation': 'Statistics Unit, QIMR Berghofer Medical Research Institute, Brisbane, Australia.'}, {'ForeName': 'Goce', 'Initials': 'G', 'LastName': 'Dimeski', 'Affiliation': 'Department of Chemical Pathology, Princess Alexandra Hospital, Faculty of Medicine, The University of Queensland, Brisbane, Australia.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Sturgess', 'Affiliation': 'From the Department of Anaesthesia, Princess Alexandra Hospital-Southern Clinical School, Faculty of Medicine, The University of Queensland, Brisbane, Australia.'}]",Anesthesia and analgesia,['10.1213/ANE.0000000000005002'] 2917,32618627,Pediatric Distraction on Induction of Anesthesia With Virtual Reality and Perioperative Anxiolysis: A Randomized Controlled Trial.,"BACKGROUND Perioperative pediatric anxiety is common and can have a negative psychological impact on children undergoing surgery and anesthesia. Studies have shown an incidence of anxiety at induction of up to 50%. Audiovisual distraction, including virtual reality (VR), is a noninvasive, nonpharmacological modality that may reduce perioperative anxiety. The goal of this study was to determine whether immersive audiovisual distraction with a VR headset during induction of general anesthesia (GA) in pediatric patients reduced preoperative anxiety. METHODS In this randomized-controlled, parallel-group study, 71 children 5-12 years of age scheduled for elective surgery with GA were randomly allocated to a VR group or a non-VR (No VR) control group. VR group patients underwent audiovisual distraction with a VR headset during induction in the operating room, whereas the control group received no audiovisual distraction. The primary outcome was the Modified Yale Preoperative Anxiety Scale (mYPAS), which was measured at 3 time points to assess patient anxiety: in the preoperative holding area before randomization, on entering the operating room, and during induction of GA. The primary outcome was analyzed using univariate analysis and a linear mixed-effects model. Secondary outcomes included postinduction parental anxiety measured by the State-Trait Anxiety Inventory, pediatric induction compliance, and parental satisfaction. RESULTS Average patient age was 8.0 ± 2.3 years (mean ± standard deviation [SD]), and 51.4% of patients were female. Baseline variables were not substantially different between the VR group (33 patients) and the No VR group (37 patients). No patients received preoperative anxiolytic medication. Baseline mYPAS scores were not different between the groups, with scores of 28.3 (23.3-28.3) (median [interquartile range {IQR}]) in both. The change in mYPAS scores from baseline to time of induction was significantly lower in the VR group versus control group (0.0 [0.0-5.0] vs 13.3 [5.0-26.7]; P< .0001). In the mixed-effects model, the VR group had an estimated 6.0-point lower mYPAS score (95% confidence interval [CI], 0.7-11.3; P= .03) at room entry than the No VR group, and 14.5-point lower score (95% CI, 9.3-19.8; P< .0001) at induction versus control. Randomization to VR did not alter parental anxiety (0 [-2 to 2]), pediatric induction compliance (0 [0-0]), or parental satisfaction (-3 [-8 to 2]) (difference in medians [95% CI]). CONCLUSIONS This study demonstrates a reduction in pediatric preoperative anxiety with the use of VR. Preoperative VR may be an effective noninvasive modality for anxiolysis during induction of anesthesia in children.",2020,Baseline variables were not substantially different between the VR group (33 patients) and the No VR group (37 patients).,"['children', 'Average patient age was 8.0 ± 2.3 years (mean ± standard deviation [SD]), and 51.4% of patients were female', 'children undergoing surgery and anesthesia', '71 children 5-12 years of age scheduled for elective surgery with GA', 'pediatric patients reduced preoperative anxiety']","['Anesthesia With Virtual Reality and Perioperative Anxiolysis', 'immersive audiovisual distraction with a VR headset during induction of general anesthesia (GA', 'Audiovisual distraction, including virtual reality (VR', 'audiovisual distraction with a VR headset', 'preoperative anxiolytic medication', 'Pediatric Distraction', 'control group received no audiovisual distraction', 'VR group or a non-VR (No VR) control group']","['Modified Yale Preoperative Anxiety Scale (mYPAS), which was measured at 3 time points to assess patient anxiety', 'pediatric induction compliance (0 [0-0]), or parental satisfaction (-3 ', 'postinduction parental anxiety measured by the State-Trait Anxiety Inventory, pediatric induction compliance, and parental satisfaction', 'mYPAS score', 'pediatric preoperative anxiety', 'parental anxiety', 'perioperative anxiety', 'Baseline mYPAS scores', 'mYPAS scores']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0035008', 'cui_str': 'Reinforcement Schedule'}, {'cui': 'C0206058', 'cui_str': 'Optional surgery'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}]","[{'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C1961138', 'cui_str': 'Induction of minimal sedation'}, {'cui': 'C0150189', 'cui_str': 'Distraction training'}, {'cui': 'C0473960', 'cui_str': 'Induction of general anesthesia'}, {'cui': 'C0002915', 'cui_str': 'General anesthesia'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0040616', 'cui_str': 'Anxiolytic agent'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}, {'cui': 'C0030551', 'cui_str': 'Parent'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0577602', 'cui_str': 'Parental anxiety'}, {'cui': 'C0683457', 'cui_str': 'State-trait anger expression inventory'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}]",71.0,0.0798988,Baseline variables were not substantially different between the VR group (33 patients) and the No VR group (37 patients).,"[{'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Jung', 'Affiliation': 'From the Department of Anesthesia and Perioperative Care, University of California, San Francisco (UCSF) Medical Center, San Francisco, California.'}, {'ForeName': 'Justin S', 'Initials': 'JS', 'LastName': 'Libaw', 'Affiliation': 'From the Department of Anesthesia and Perioperative Care, University of California, San Francisco (UCSF) Medical Center, San Francisco, California.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Ma', 'Affiliation': 'From the Department of Anesthesia and Perioperative Care, University of California, San Francisco (UCSF) Medical Center, San Francisco, California.'}, {'ForeName': 'Elizabeth L', 'Initials': 'EL', 'LastName': 'Whitlock', 'Affiliation': 'From the Department of Anesthesia and Perioperative Care, University of California, San Francisco (UCSF) Medical Center, San Francisco, California.'}, {'ForeName': 'John R', 'Initials': 'JR', 'LastName': 'Feiner', 'Affiliation': 'From the Department of Anesthesia and Perioperative Care, University of California, San Francisco (UCSF) Medical Center, San Francisco, California.'}, {'ForeName': 'Jina L', 'Initials': 'JL', 'LastName': 'Sinskey', 'Affiliation': 'From the Department of Anesthesia and Perioperative Care, University of California, San Francisco (UCSF) Medical Center, San Francisco, California.'}]",Anesthesia and analgesia,['10.1213/ANE.0000000000005004'] 2918,32618656,Allogenic Fecal Microbiota Transplantation in Patients With Nonalcoholic Fatty Liver Disease Improves Abnormal Small Intestinal Permeability: A Randomized Control Trial.,"INTRODUCTION Nonalcoholic fatty liver disease (NAFLD) is an obesity-related disorder that is rapidly increasing in incidence and is considered the hepatic manifestation of the metabolic syndrome. The gut microbiome plays a role in metabolism and maintaining gut barrier integrity. Studies have found differences in the microbiota between NAFLD and healthy patients and increased intestinal permeability in patients with NAFLD. Fecal microbiota transplantation (FMT) can be used to alter the gut microbiome. It was hypothesized that an FMT from a thin and healthy donor given to patients with NAFLD would improve insulin resistance (IR), hepatic proton density fat fraction (PDFF), and intestinal permeability. METHODS Twenty-one patients with NAFLD were recruited and randomized in a ratio of 3:1 to either an allogenic (n = 15) or an autologous (n = 6) FMT delivered by using an endoscope to the distal duodenum. IR was calculated by HOMA-IR, hepatic PDFF was measured by MRI, and intestinal permeability was tested using the lactulose:mannitol urine test. Additional markers of metabolic syndrome and the gut microbiota were examined. Patient visits occurred at baseline, 2, 6 weeks, and 6 months post-FMT. RESULTS There were no significant changes in HOMA-IR or hepatic PDFF in patients who received the allogenic or autologous FMT. Allogenic FMT patients with elevated small intestinal permeability (>0.025 lactulose:mannitol, n = 7) at baseline had a significant reduction 6 weeks after allogenic FMT. DISCUSSION FMT did not improve IR as measured by HOMA-IR or hepatic PDFF but did have the potential to reduce small intestinal permeability in patients with NAFLD.",2020,There were no significant changes in HOMA-IR or hepatic PDFF in patients who received the allogenic or autologous FMT.,"['Patients With Nonalcoholic Fatty Liver Disease Improves', 'patients with NAFLD', 'Twenty-one patients with NAFLD', 'Abnormal Small Intestinal Permeability']","['Allogenic Fecal Microbiota Transplantation', 'Fecal microbiota transplantation (FMT', 'allogenic (n = 15) or an autologous (n = 6) FMT delivered by using an endoscope to the distal duodenum', 'FMT', 'allogenic or autologous FMT', 'Allogenic FMT']","['HOMA-IR or hepatic PDFF', 'Patient visits', 'intestinal permeability', 'insulin resistance (IR), hepatic proton density fat fraction (PDFF), and intestinal permeability', 'small intestinal permeability', 'HOMA-IR, hepatic PDFF was measured by MRI, and intestinal permeability']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0400966', 'cui_str': 'Non-alcoholic fatty liver'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C3715213', 'cui_str': '21'}, {'cui': 'C0205161', 'cui_str': 'Abnormal'}, {'cui': 'C0021852', 'cui_str': 'Small intestinal'}, {'cui': 'C0031164', 'cui_str': 'Permeability'}]","[{'cui': 'C2242628', 'cui_str': 'Fecal microbiota transplantation'}, {'cui': 'C0439859', 'cui_str': 'Autologous'}, {'cui': 'C0014243', 'cui_str': 'Endoscope'}, {'cui': 'C0205108', 'cui_str': 'Distal'}, {'cui': 'C0013303', 'cui_str': 'Duodenal'}]","[{'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C0033727', 'cui_str': 'Proton'}, {'cui': 'C0178587', 'cui_str': 'Density'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C1264633', 'cui_str': 'Fraction of'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0031164', 'cui_str': 'Permeability'}, {'cui': 'C0021852', 'cui_str': 'Small intestinal'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}]",21.0,0.0335215,There were no significant changes in HOMA-IR or hepatic PDFF in patients who received the allogenic or autologous FMT.,"[{'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Craven', 'Affiliation': 'Department of Microbiology and Immunology, Western University, London, Ontario, Canada.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Rahman', 'Affiliation': 'Lawson Health Research Institute, London, Ontario, Canada.'}, {'ForeName': 'Seema', 'Initials': 'S', 'LastName': 'Nair Parvathy', 'Affiliation': ""Division of Infectious Disease, St. Joseph's Health Care, London, Ontario, Canada.""}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Beaton', 'Affiliation': 'Lawson Health Research Institute, London, Ontario, Canada.'}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Silverman', 'Affiliation': 'Program in Computational Biology and Bioinformatics, Duke University, Durham, North Carolina, USA.'}, {'ForeName': 'Karim', 'Initials': 'K', 'LastName': 'Qumosani', 'Affiliation': 'Lawson Health Research Institute, London, Ontario, Canada.'}, {'ForeName': 'Irene', 'Initials': 'I', 'LastName': 'Hramiak', 'Affiliation': 'Lawson Health Research Institute, London, Ontario, Canada.'}, {'ForeName': 'Rob', 'Initials': 'R', 'LastName': 'Hegele', 'Affiliation': 'Lawson Health Research Institute, London, Ontario, Canada.'}, {'ForeName': 'Tisha', 'Initials': 'T', 'LastName': 'Joy', 'Affiliation': 'Lawson Health Research Institute, London, Ontario, Canada.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Meddings', 'Affiliation': 'Department of Medicine, University of Calgary, Alberta, Canada.'}, {'ForeName': 'Brad', 'Initials': 'B', 'LastName': 'Urquhart', 'Affiliation': 'Lawson Health Research Institute, London, Ontario, Canada.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Harvie', 'Affiliation': 'The Canadian Centre for Microbiome and Probiotic Research, London, Ontario, Canada.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'McKenzie', 'Affiliation': 'Lawson Health Research Institute, London, Ontario, Canada.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Summers', 'Affiliation': 'Department of Microbiology and Immunology, Western University, London, Ontario, Canada.'}, {'ForeName': 'Gregor', 'Initials': 'G', 'LastName': 'Reid', 'Affiliation': 'Department of Microbiology and Immunology, Western University, London, Ontario, Canada.'}, {'ForeName': 'Jeremy P', 'Initials': 'JP', 'LastName': 'Burton', 'Affiliation': 'Department of Microbiology and Immunology, Western University, London, Ontario, Canada.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Silverman', 'Affiliation': 'Department of Microbiology and Immunology, Western University, London, Ontario, Canada.'}]",The American journal of gastroenterology,['10.14309/ajg.0000000000000661'] 2919,32618692,Prospective Randomized Controlled Trial of Video- Versus Recall-Assisted Reflection in Simulation-Based Teaching on Acquisition and Retention of Airway Skills Among Trainees Intubating Critically Ill Patients.,"OBJECTIVES Conventionally, simulation-based teaching involves reflection on recalled events (recall-assisted reflection). Instead of recall, video-assisted reflection may reduce recall bias and improve skills retention by contributing to visual memory. Here, we test the hypothesis that when compared with recall, video-assisted reflection results in higher acquisition and retention of skills involved in airway management among junior critical care doctors. DESIGN Randomized control trial. Participants were randomized 1:1 to video-assisted reflection or recall-assisted reflection group. SETTING University-affiliated tertiary care center. SUBJECTS Junior critical care doctors. INTERVENTION Video-assisted reflection. MEASUREMENTS AND MAIN RESULTS All participants underwent simulation-based teaching of technical and nontechnical airway skills involved in managing a critically ill patient. These skills were assessed before, post-workshop, and in the following fourth week, by two independent blinded assessors using a validated scoring tool. Quality of debrief was assessed using a validated questionnaire. Repeated-measures analysis of variance was used to assess time and group interaction. Forty doctors were randomized. At baseline, the groups had similar airway experience (p = 0.34) and skill scores (p = 0.97). There was a significant interaction between study groups and changes over time for total skill scores (F[2, 37] = 4.06; p = 0.02). Although both the study groups had similar and significant improvement in total skills scores at the postworkshop assessment, the decline in total skills scores at delayed assessment (F[1, 38] = 5.64; p = 0.02) was significantly more in the recall-assisted reflection group when compared with the video-assisted reflection group. This resulted in lower mean skill scores in the recall-assisted reflection group when compared with the video-assisted reflection group in the delayed assessment (89.45 [19.32] vs 110.10 [19.54]; p < 0.01). Better retention was predominantly in the nontechnical skills. The perceived quality of debrief was similar between the two groups. CONCLUSION When compared with recall, video-assisted reflection resulted in similar improvement in airway skills, but better retention over time.",2020,This resulted in lower mean skill scores in the recall-assisted reflection group when compared with the video-assisted reflection group in the delayed assessment (89.45 [19.32] vs 110.10 [19.54]; p < 0.01).,"['junior critical care doctors', 'Intubating Critically Ill Patients', 'Junior critical care doctors', 'Forty doctors', 'University-affiliated tertiary care center', 'Trainees']","['video-assisted reflection or recall-assisted reflection group', 'Video', 'Video-assisted reflection']","['total skills scores', 'quality of debrief', 'airway skills', 'mean skill scores', 'Skills', 'recall bias and improve skills retention', 'total skill scores', 'Acquisition and Retention of Airway', 'similar airway experience', 'skill scores', 'Quality of debrief']","[{'cui': 'C0010337', 'cui_str': 'Care of intensive care unit patient'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0587437', 'cui_str': 'Tertiary referral hospital'}]","[{'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}]","[{'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0332306', 'cui_str': 'Quality'}, {'cui': 'C0178987', 'cui_str': 'Airway device'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C0005346', 'cui_str': 'Biases'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0035280', 'cui_str': 'Retention (Psychology)'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}]",40.0,0.212539,This resulted in lower mean skill scores in the recall-assisted reflection group when compared with the video-assisted reflection group in the delayed assessment (89.45 [19.32] vs 110.10 [19.54]; p < 0.01).,"[{'ForeName': 'Shivesh', 'Initials': 'S', 'LastName': 'Prakash', 'Affiliation': 'College of Medicine and Public Health, Flinders University, Adelaide, SA, Australia.'}, {'ForeName': 'Shailesh', 'Initials': 'S', 'LastName': 'Bihari', 'Affiliation': 'College of Medicine and Public Health, Flinders University, Adelaide, SA, Australia.'}, {'ForeName': 'Russell', 'Initials': 'R', 'LastName': 'Laver', 'Affiliation': 'College of Medicine and Public Health, Flinders University, Adelaide, SA, Australia.'}, {'ForeName': 'Giresh', 'Initials': 'G', 'LastName': 'Chandran', 'Affiliation': 'Department of Anaesthesia, Flinders Medical Centre, Bedford Park, SA, Australia.'}, {'ForeName': 'Lachlan', 'Initials': 'L', 'LastName': 'Kerr', 'Affiliation': 'College of Medicine and Public Health, Flinders University, Adelaide, SA, Australia.'}, {'ForeName': 'Lambert', 'Initials': 'L', 'LastName': 'Schuwirth', 'Affiliation': 'College of Medicine and Public Health, Flinders University, Adelaide, SA, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Bersten', 'Affiliation': 'College of Medicine and Public Health, Flinders University, Adelaide, SA, Australia.'}]",Critical care medicine,['10.1097/CCM.0000000000004448'] 2920,32621467,[A study of the efficacy and safety of lornoxicam in patients with acute sciatica].,"OBJECTIVE To compare the efficacy, safety and tolerability of lornoxicam and xefocam used as the reference drug in patients with acute nonspecific pain in lower back caused by acute sciatica. MATERIAL AND METHODS A simple blind clinical study was conducted with 108 patients (men and women, aged 20-55 years) with complaints of pain in the lower back and an established diagnosis of vertebrogenic radiculopathy L4, L5, S1. Patients were randomized into 2 treatment groups by randomization method of envelopes in the ratio of 1:1 (54 patients per group). The first group received lornoxicam in a dose of 16 mg/day for 2 days, the second group was treated with xefocam (the lyophilisate for preparation of solution for intravenous and intramuscular injection) according to a similar scheme. RESULTS AND CONCLUSION The results demonstrate the comparable efficacy of lornoxicam and the reference drug. The analysis of the safety profile reveals no significant differences between treatment groups.",2020,The analysis of the safety profile reveals no significant differences between treatment groups.,"['108 patients (men and women, aged 20-55 years) with complaints of pain in the lower back and an established diagnosis of vertebrogenic radiculopathy L4, L5, S1', 'patients with acute sciatica', 'patients with acute nonspecific pain in lower back caused by acute sciatica']","['lornoxicam and xefocam', 'lornoxicam', 'xefocam (the lyophilisate for preparation of solution for intravenous and intramuscular injection']","['efficacy and safety', 'efficacy, safety and tolerability']","[{'cui': 'C4517530', 'cui_str': '108'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0277786', 'cui_str': 'Complaint'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0700594', 'cui_str': 'Radiculopathy'}, {'cui': 'C0585051', 'cui_str': 'Acute sciatica'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0015127', 'cui_str': 'etiology'}]","[{'cui': 'C0055477', 'cui_str': 'lornoxicam'}, {'cui': 'C4518549', 'cui_str': 'Lyophilisate'}, {'cui': 'C0037633', 'cui_str': 'Solution'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}, {'cui': 'C0021492', 'cui_str': 'Intramuscular injection'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",108.0,0.034983,The analysis of the safety profile reveals no significant differences between treatment groups.,"[{'ForeName': 'V V', 'Initials': 'VV', 'LastName': 'Popov', 'Affiliation': 'Scientific Medical Center, JSC Russian Railways, Moscow, Russia.'}, {'ForeName': 'G N', 'Initials': 'GN', 'LastName': 'Gildeeva', 'Affiliation': 'Sechenov First Moscow State Medical University of the Ministry of Health of the Russia (Sechenov University), Moscow, Russia.'}, {'ForeName': 'D V', 'Initials': 'DV', 'LastName': 'Butuzova', 'Affiliation': 'Medical Development Agency LLC, Moscow, Russia.'}, {'ForeName': 'E A', 'Initials': 'EA', 'LastName': 'Ezhova', 'Affiliation': 'Moscow Endocrine Plant, Moscow, Russia.'}, {'ForeName': 'A V', 'Initials': 'AV', 'LastName': 'Belostotskiy', 'Affiliation': 'Sechenov First Moscow State Medical University of the Ministry of Health of the Russia (Sechenov University), Moscow, Russia.'}, {'ForeName': 'N A', 'Initials': 'NA', 'LastName': 'Bulanova', 'Affiliation': 'Sechenov First Moscow State Medical University of the Ministry of Health of the Russia (Sechenov University), Moscow, Russia.'}]",Zhurnal nevrologii i psikhiatrii imeni S.S. Korsakova,['10.17116/jnevro202012005142'] 2921,32621543,Pharmacokinetics of the Monoclonal Antibody MHAA4549A Administered in Combination With Oseltamivir in Patients Hospitalized With Severe Influenza A Infection.,"MHAA4549A is a human anti-influenza A monoclonal antibody developed to treat influenza A. We report MHAA4549A serum, nasopharyngeal, and tracheal aspirate pharmacokinetics from a phase 2b study in hospitalized patients with severe influenza A. Patients were randomized 1:1:1 into 3 groups receiving single intravenous doses of 3600 mg (n = 55) or 8400 mg (n = 47) MHAA4549A or placebo (n = 56). Patients also received oral oseltamivir twice daily for ≥5 days. Serum, nasopharyngeal, and tracheal aspirate pharmacokinetic samples were collected on days 1-60 from MHAA4549A-treated groups. Day 5 plasma samples from all groups were collected for assessing the pharmacokinetics of oseltamivir and its active metabolite, oseltamivir carboxylate. Noncompartmental pharmacokinetic analysis was performed using Phoenix WinNonlin. Data were collected during a preplanned interim analysis that became final when the trial terminated because of a lack of efficacy. Serum MHAA4549A concentrations were dose-proportional and biphasic. Mean MHAA4549A clearance was 288-350 mL/day, and mean half-life was 17.8-19.0 days. Nasopharyngeal MHAA4549A concentrations were non-dose-proportional. We detected MHAA4549A in tracheal aspirate samples, but intersubject variability was high. MHAA4549A serum and nasopharyngeal exposures were confirmed in all MHAA4549A-treated patients. Serum MHAA4549A had faster clearance and a shorter half-life in influenza A-infected patients compared with healthy subjects. MHAA4549A detection in tracheal aspirate samples indicated exposure in the lower respiratory tract. Oseltamivir and oseltamivir carboxylate exposures were similar between MHAA4549A-treated and placebo groups, suggesting a lack of MHAA4549A interference with oseltamivir pharmacokinetics.",2020,Serum MHAA4549A had faster clearance and a shorter half-life in influenza A-infected patients compared with healthy subjects.,"['Patients Hospitalized With Severe Influenza A Infection', 'hospitalized patients with severe influenza A. Patients']","['MHAA4549A-treated and placebo', 'oral oseltamivir', 'Monoclonal Antibody MHAA4549A', 'MHAA4549A', 'MHAA4549A or placebo']","['Serum, nasopharyngeal, and tracheal aspirate pharmacokinetic samples', 'MHAA4549A serum and nasopharyngeal exposures', 'Serum MHAA4549A concentrations', 'Mean MHAA4549A clearance', 'Nasopharyngeal MHAA4549A concentrations']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0701159', 'cui_str': 'Patient in hospital'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C1615607', 'cui_str': 'Influenza A virus subtype H1N1'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C0021400', 'cui_str': 'Influenza'}]","[{'cui': 'C5139963', 'cui_str': 'MHAA4549A'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0874161', 'cui_str': 'Oseltamivir'}, {'cui': 'C0003250', 'cui_str': 'Monoclonal antibody'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0027442', 'cui_str': 'Nasopharyngeal'}, {'cui': 'C2919642', 'cui_str': 'Specimen from trachea obtained by aspiration'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C5139963', 'cui_str': 'MHAA4549A'}, {'cui': 'C0274281', 'cui_str': 'Effect of exposure to external cause'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}]",,0.04558,Serum MHAA4549A had faster clearance and a shorter half-life in influenza A-infected patients compared with healthy subjects.,"[{'ForeName': 'Rong', 'Initials': 'R', 'LastName': 'Deng', 'Affiliation': 'Genentech, Inc, South San Francisco, California, USA.'}, {'ForeName': 'Gaohong', 'Initials': 'G', 'LastName': 'She', 'Affiliation': 'Genentech, Inc, South San Francisco, California, USA.'}, {'ForeName': 'Mauricio', 'Initials': 'M', 'LastName': 'Maia', 'Affiliation': 'Genentech, Inc, South San Francisco, California, USA.'}, {'ForeName': 'Jeremy J', 'Initials': 'JJ', 'LastName': 'Lim', 'Affiliation': 'Genentech, Inc, South San Francisco, California, USA.'}, {'ForeName': 'Melicent C', 'Initials': 'MC', 'LastName': 'Peck', 'Affiliation': 'Genentech, Inc, South San Francisco, California, USA.'}, {'ForeName': 'Jacqueline M', 'Initials': 'JM', 'LastName': 'McBride', 'Affiliation': 'Genentech, Inc, South San Francisco, California, USA.'}, {'ForeName': 'Priya', 'Initials': 'P', 'LastName': 'Kulkarni', 'Affiliation': 'Genentech, Inc, South San Francisco, California, USA.'}, {'ForeName': 'Priscilla', 'Initials': 'P', 'LastName': 'Horn', 'Affiliation': 'Genentech, Inc, South San Francisco, California, USA.'}, {'ForeName': 'Aide', 'Initials': 'A', 'LastName': 'Castro', 'Affiliation': 'Genentech, Inc, South San Francisco, California, USA.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Newton', 'Affiliation': 'Genentech, Inc, South San Francisco, California, USA.'}, {'ForeName': 'Jorge A', 'Initials': 'JA', 'LastName': 'Tavel', 'Affiliation': 'Genentech, Inc, South San Francisco, California, USA.'}, {'ForeName': 'William D', 'Initials': 'WD', 'LastName': 'Hanley', 'Affiliation': 'Genentech, Inc, South San Francisco, California, USA.'}]",Journal of clinical pharmacology,['10.1002/jcph.1652'] 2922,32589978,"Hyper-CVAD regimen in combination with ofatumumab as frontline therapy for adults with Philadelphia chromosome-negative B-cell acute lymphoblastic leukaemia: a single-arm, phase 2 trial.","BACKGROUND The addition of rituximab to intensive chemotherapy improves outcomes in patients with B-cell acute lymphoblastic leukaemia. Ofatumumab is an anti-CD20 monoclonal antibody that binds to the small extracellular loop of CD20 and has greater in vitro complement-mediated cytotoxicity than rituximab. In this study, we assessed the activity and safety of ofatumumab in combination with chemotherapy in patients with Philadelphia chromosome (Ph)-negative CD20-positive B-cell acute lymphoblastic leukaemia. METHODS This was a single-arm, phase 2 trial done at the MD Anderson Cancer Center (Houston, TX, USA). Patients with newly diagnosed, Ph-negative B-cell acute lymphoblastic leukaemia or lymphoblastic lymphoma with CD20 expression of at least 1% were eligible. Patients were treated with up to eight courses of the hyper-CVAD regimen (hyperfractionated cyclophosphamide, vincristine, doxorubicin, and dexamethasone) on courses 1, 3, 5, and 7 alternating with high-dose methotrexate and cytarabine on courses 2, 4, 6, and 8. Ofatumumab was administered on days 1 and 11 of courses 1 and 3 and on days 1 and 8 of courses 2 and 4 for a total of eight doses. The first dose of ofatumumab was 300 mg intravenously and all subsequent doses were 2000 mg intravenously. Patients received 30 courses of maintenance therapy with 6-mercaptopurine, vincristine, methotrexate, and prednisone (POMP), with four intensification courses (high-dose methotrexate plus L-asparaginase and hyper-CVAD plus ofatumumab on courses 6-7 and 18-19). The primary endpoints were event-free survival, overall response, and overall survival. All enrolled patients were included in the primary and safety analyses. The trial is registered with ClinicalTrials.gov, NCT01363128. FINDINGS Between Aug 26, 2011, and May 18, 2017, 69 patients (67 patients had B-cell acute lymphoblastic leukaemia and two had B-cell lymphoblastic lymphoma; median age 41 years [IQR 32-50]) were enrolled and treated, including 33 (48%) aged between 18 and 39 years. Nine (27%) of 33 patients had Ph-like acute lymphoblastic leukaemia. With a median follow-up of 44 months (26-53), 4-year event-free survival was 59% (95% CI 48-73); 69% (54-87) in adolescents and young adults aged 18-39 years. 4-year overall survival was 68% (58-81); 74% (60-91) in adolescents and young adults. The overall response rate was 98% (64 of 65 patients). The most common non-haematological grade 3 or 4 adverse events were infections (35 [54%] of 65 patients during induction and 53 [78%] of 68 patients during consolidation). Ten (14%) of 69 patients died in complete remission from sepsis (two [3%]), cardiac arrest (one [1%]), therapy-related acute myeloid leukaemia (two [3%]), and haematopoietic stem-cell transplantation complications (five [7%]). None of these deaths were considered related to ofatumumab treatment by the study investigators. INTERPRETATION The combination of hyper-CVAD plus ofatumumab is safe and active in adults with Ph-negative CD20-positive B-cell acute lymphoblastic leukaemia. Modifications of this regimen with the addition of novel monoclonal and bispecific antibody constructs targeting CD19 and CD22 might further improve outcomes and allow reduction in the intensity and duration of chemotherapy. FUNDING Novartis.",2020,4-year overall survival was 68% (58-81); 74% (60-91) in adolescents and young adults.,"['adults with Philadelphia chromosome-negative B-cell acute lymphoblastic leukaemia', '33 patients had Ph-like acute lymphoblastic leukaemia', 'patients with Philadelphia chromosome (Ph)-negative CD20-positive B-cell acute lymphoblastic leukaemia', 'adults with Ph-negative CD20-positive B-cell acute lymphoblastic leukaemia', 'Between Aug 26, 2011, and May 18, 2017', '69 patients (67 patients had B-cell acute lymphoblastic leukaemia and two had B-cell lymphoblastic lymphoma; median age 41 years [IQR 32-50]) were enrolled and treated, including 33 (48%) aged between 18 and 39 years', 'patients with B-cell acute lymphoblastic leukaemia', 'Patients with newly diagnosed, Ph-negative B-cell acute lymphoblastic leukaemia or lymphoblastic lymphoma with CD20 expression of at least 1% were eligible']","['6-mercaptopurine, vincristine, methotrexate, and prednisone (POMP), with four intensification courses (high-dose methotrexate plus L-asparaginase and hyper-CVAD plus ofatumumab', 'hyper-CVAD plus ofatumumab', 'ofatumumab in combination with chemotherapy', 'hyper-CVAD regimen (hyperfractionated cyclophosphamide, vincristine, doxorubicin, and dexamethasone', 'methotrexate and cytarabine', 'Hyper-CVAD regimen in combination with ofatumumab', 'rituximab']","['event-free survival, overall response, and overall survival', '4-year event-free survival', 'activity and safety', 'cardiac arrest', 'overall response rate', 'haematopoietic stem-cell transplantation complications', 'complete remission from sepsis', 'therapy-related acute myeloid leukaemia', '4-year overall survival']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C3888511', 'cui_str': 'Philadelphia chromosome negative'}, {'cui': 'C4721444', 'cui_str': 'Burkitt cell leukemia'}, {'cui': 'C0332310', 'cui_str': 'Has patient'}, {'cui': 'C0031526', 'cui_str': 'Ph1 Chromosome'}, {'cui': 'C0023449', 'cui_str': 'Acute lymphoid leukemia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C3888518', 'cui_str': 'CD20 antigen positive'}, {'cui': 'C0004561', 'cui_str': 'B lymphocyte'}, {'cui': 'C0079748', 'cui_str': 'Precursor cell lymphoblastic lymphoma'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0054946', 'cui_str': 'Lymphocyte antigen CD20'}, {'cui': 'C0015457', 'cui_str': 'Facial expression'}]","[{'cui': 'C0000618', 'cui_str': 'mercaptopurine'}, {'cui': 'C0042679', 'cui_str': 'Vincristine'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0003993', 'cui_str': 'ASPARAGINASE'}, {'cui': 'C0082139', 'cui_str': 'CVAD protocol'}, {'cui': 'C1832027', 'cui_str': 'ofatumumab'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0040808', 'cui_str': 'Protocols, Treatment'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0010711', 'cui_str': 'Cytarabine'}, {'cui': 'C0393022', 'cui_str': 'rituximab'}]","[{'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0018790', 'cui_str': 'Cardiac arrest'}, {'cui': 'C0018956', 'cui_str': 'Hematopoietic stem cell'}, {'cui': 'C3804957', 'cui_str': 'Transplantation complication'}, {'cui': 'C0677874', 'cui_str': 'In full remission'}, {'cui': 'C0036690', 'cui_str': 'Septicaemia, unspecified'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0023467', 'cui_str': 'Acute myeloid leukemia'}]",,0.229832,4-year overall survival was 68% (58-81); 74% (60-91) in adolescents and young adults.,"[{'ForeName': 'Elias', 'Initials': 'E', 'LastName': 'Jabbour', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA. Electronic address: ejabbour@mdanderson.org.'}, {'ForeName': 'Guillaume', 'Initials': 'G', 'LastName': 'Richard-Carpentier', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Yuya', 'Initials': 'Y', 'LastName': 'Sasaki', 'Affiliation': 'Department of Genomic Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Marina', 'Initials': 'M', 'LastName': 'Konopleva', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Keyur', 'Initials': 'K', 'LastName': 'Patel', 'Affiliation': 'Department of Hematopathology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Roberts', 'Affiliation': ""Department of Pathology, St Jude Children's Research Hospital, Memphis, TN, USA.""}, {'ForeName': 'Zhaohui', 'Initials': 'Z', 'LastName': 'Gu', 'Affiliation': ""Department of Pathology, St Jude Children's Research Hospital, Memphis, TN, USA.""}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Wang', 'Affiliation': 'Department of Genomic Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Xuelin', 'Initials': 'X', 'LastName': 'Huang', 'Affiliation': 'Department of Biostatistics, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Koji', 'Initials': 'K', 'LastName': 'Sasaki', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Nicholas J', 'Initials': 'NJ', 'LastName': 'Short', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Nitin', 'Initials': 'N', 'LastName': 'Jain', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Farhad', 'Initials': 'F', 'LastName': 'Ravandi', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Naval G', 'Initials': 'NG', 'LastName': 'Daver', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Tapan M', 'Initials': 'TM', 'LastName': 'Kadia', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Yesid', 'Initials': 'Y', 'LastName': 'Alvarado', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Courtney D', 'Initials': 'CD', 'LastName': 'DiNardo', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Ghayas C', 'Initials': 'GC', 'LastName': 'Issa', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Naveen', 'Initials': 'N', 'LastName': 'Pemmaraju', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Guillermo', 'Initials': 'G', 'LastName': 'Garcia-Manero', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Srdan', 'Initials': 'S', 'LastName': 'Verstovsek', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Sa', 'Initials': 'S', 'LastName': 'Wang', 'Affiliation': 'Department of Hematopathology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Joseph D', 'Initials': 'JD', 'LastName': 'Khoury', 'Affiliation': 'Department of Hematopathology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Jeffrey', 'Initials': 'J', 'LastName': 'Jorgensen', 'Affiliation': 'Department of Hematopathology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Champlin', 'Affiliation': 'Department of Stem Cell Transplantation and Cellular Therapy, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Issa', 'Initials': 'I', 'LastName': 'Khouri', 'Affiliation': 'Department of Stem Cell Transplantation and Cellular Therapy, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Partow', 'Initials': 'P', 'LastName': 'Kebriaei', 'Affiliation': 'Department of Stem Cell Transplantation and Cellular Therapy, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Schroeder', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Khouri', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Charles G', 'Initials': 'CG', 'LastName': 'Mullighan', 'Affiliation': ""Department of Pathology, St Jude Children's Research Hospital, Memphis, TN, USA.""}, {'ForeName': 'Koichi', 'Initials': 'K', 'LastName': 'Takahashi', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA; Department of Genomic Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Susan M', 'Initials': 'SM', 'LastName': ""O'Brien"", 'Affiliation': 'Division of Hematology/Oncology, Department of Medicine, UCI Health, Orange, CA, USA.'}, {'ForeName': 'Hagop', 'Initials': 'H', 'LastName': 'Kantarjian', 'Affiliation': 'Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}]",The Lancet. Haematology,['10.1016/S2352-3026(20)30144-7'] 2923,30169607,Do Intracerebral Cytokine Responses Explain the Harmful Effects of Dexamethasone in Human Immunodeficiency Virus-associated Cryptococcal Meningitis?,"BACKGROUND The CryptoDex trial showed that dexamethasone caused poorer clinical outcomes and slowed fungal clearance in human immunodeficiency virus-associated cryptococcal meningitis. We analyzed cerebrospinal fluid (CSF) cytokine concentrations from participants over the first week of treatment to investigate mechanisms of harm and test 2 hypotheses: (1) dexamethasone reduced proinflammatory cytokine concentrations, leading to poorer outcomes and (2) leukotriene A4 hydrolase (LTA4H) genotype influenced the clinical impact of dexamethasone, as observed in tuberculous meningitis. METHODS We included participants from Vietnam, Thailand, and Uganda. Using the Luminex system, we measured CSF concentrations of the following: interferon γ, tumor necrosis factor (TNF) α, granulocyte-macrophage colony-stimulating factor, monocyte chemoattractant 1, macrophage inflammatory protein 1α, and interleukin 6, 12p70, 8, 4, 10, and 17. We determined the LTA4H genotype based on the promoter region single-nucleotide polymorphism rs17525495. We assessed the impact of dexamethasone on cytokine concentration dynamics and the association between cytokine concentration dynamics and fungal clearance with mixed effect models. We measured the influence of LTA4H genotype on outcomes with Cox regression models. RESULTS Dexamethasone increased the rate TNF-α concentration's decline in (-0.13 log2pg/mL/d (95% confidence interval, -.22 to -.06 log2pg/mL/d; P = .03), which was associated with slower fungal clearance (correlation, -0.62; 95% confidence interval, -.83 to -.26). LTA4H genotype had no statistically significant impact on outcome or response to dexamethasone therapy. Better clinical outcomes were associated with higher baseline concentrations of interferon γ. CONCLUSIONS Dexamethasone may slow fungal clearance and worsen outcomes by increasing TNF-α concentration's rate of decline.",2019,"RESULTS Dexamethasone increased the rate TNF-α concentration's decline in (-0.13 log2pg/mL/d (95% confidence interval, -.22 to -.06 log2pg/mL/d; P = .03), which was associated with slower fungal clearance (correlation, -0.62; 95% confidence interval, -.83 to -.26).","['participants from Vietnam, Thailand, and Uganda', 'human immunodeficiency virus-associated cryptococcal meningitis']","['dexamethasone', 'Dexamethasone']","['slower fungal clearance', 'cerebrospinal fluid (CSF) cytokine concentrations', 'CSF concentrations', 'proinflammatory cytokine concentrations', ""rate TNF-α concentration's decline""]","[{'cui': 'C0042658', 'cui_str': 'Vietnam'}, {'cui': 'C0039725', 'cui_str': 'Thailand'}, {'cui': 'C0041573', 'cui_str': 'Uganda'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0085436', 'cui_str': 'Cryptococcal meningitis'}]","[{'cui': 'C0011777', 'cui_str': 'Dexamethasone'}]","[{'cui': 'C0439834', 'cui_str': 'Slow'}, {'cui': 'C0521033', 'cui_str': 'fungi'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0007806', 'cui_str': 'Cerebrospinal fluid'}, {'cui': 'C0079189', 'cui_str': 'Cytokine'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0041368', 'cui_str': 'TNF Receptor Ligands'}]",,0.209762,"RESULTS Dexamethasone increased the rate TNF-α concentration's decline in (-0.13 log2pg/mL/d (95% confidence interval, -.22 to -.06 log2pg/mL/d; P = .03), which was associated with slower fungal clearance (correlation, -0.62; 95% confidence interval, -.83 to -.26).","[{'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Beardsley', 'Affiliation': 'Oxford University Clinical Research Unit, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Nhat L T', 'Initials': 'NLT', 'LastName': 'Hoang', 'Affiliation': 'Oxford University Clinical Research Unit, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Freddie M', 'Initials': 'FM', 'LastName': 'Kibengo', 'Affiliation': 'MRC Masaka and MRC/UVRI & LSHTM Uganda Research Unit, Entebbe.'}, {'ForeName': 'Nguyen L N', 'Initials': 'NLN', 'LastName': 'Tung', 'Affiliation': 'Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Tran Q', 'Initials': 'TQ', 'LastName': 'Binh', 'Affiliation': 'Department of Tropical Medicine, Cho Ray Hospital, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Le Q', 'Initials': 'LQ', 'LastName': 'Hung', 'Affiliation': 'Department of Tropical Medicine, Cho Ray Hospital, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Wirongrong', 'Initials': 'W', 'LastName': 'Chierakul', 'Affiliation': 'Mahidol Oxford Tropical Medicine Research Unit, Mahidol University, Bangkok, Thailand.'}, {'ForeName': 'Guy E', 'Initials': 'GE', 'LastName': 'Thwaites', 'Affiliation': 'Oxford University Clinical Research Unit, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Nguyen V V', 'Initials': 'NVV', 'LastName': 'Chau', 'Affiliation': 'Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Thuong T T', 'Initials': 'TTT', 'LastName': 'Nguyen', 'Affiliation': 'Oxford University Clinical Research Unit, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Ronald B', 'Initials': 'RB', 'LastName': 'Geskus', 'Affiliation': 'Oxford University Clinical Research Unit, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Jeremy N', 'Initials': 'JN', 'LastName': 'Day', 'Affiliation': 'Oxford University Clinical Research Unit, Ho Chi Minh City, Vietnam.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciy725'] 2924,30600136,Efficacy and safety of insulin glargine/lixisenatide (iGlarLixi) fixed-ratio combination in older adults with type 2 diabetes.,"AIMS This study assessed the efficacy and safety of iGlarLixi (a titratable, fixed-ratio combination of insulin glargine [iGlar] plus lixisenatide) in older patients with type 2 diabetes. METHODS This post hoc analysis used patient-level data from patients aged ≥65 years from the phase III LixiLan-O and LixiLan-L studies, which compared iGlarLixi with iGlar and lixisenatide (LixiLan-O only). Efficacy endpoints were changes in glycated hemoglobin A1C, fasting plasma glucose, postprandial glucose, weight, and achievement of A1C <7.0% (53 mmol/mol). Safety measures included incidence of documented symptomatic hypoglycemia (defined as typical symptoms of hypoglycemia plus self-measured plasma glucose ≤70 mg/dL [3.9 mmol/L]), severe hypoglycemia (requiring assistance of another person), and incidence of gastrointestinal adverse events. Results were compared with those from patients aged <65 years. RESULTS In both trials, older patients treated with iGlarLixi achieved significantly greater reductions in A1C at Week 30 than comparators. Treatment with iGlarLixi mitigated insulin-associated weight gain and lixisenatide-associated gastrointestinal events. Results were largely comparable between patients aged ≥65 versus <65 years. CONCLUSIONS iGlarLixi provides significant improvements in glycemic control in patients aged ≥65 years without increasing hypoglycemia risk. As a once-daily injection, it simplifies treatment regimens and may contribute to improved adherence in this patient population.",2019,"In both trials, older patients treated with iGlarLixi achieved significantly greater reductions in A1C at Week 30 than comparators.","['patients aged ≥65\u202fyears from the phase III LixiLan-O and LixiLan-L studies, which compared iGlarLixi with iGlar and lixisenatide (LixiLan-O only', 'patients aged <65\u202fyears', 'older adults with type 2 diabetes', 'patients aged ≥65 versus <65\u202fyears', 'patients aged ≥65\u202fyears without increasing hypoglycemia risk', 'older patients with type 2 diabetes']","['dL', 'iGlarLixi', 'iGlarLixi (a titratable, fixed-ratio combination of insulin glargine [iGlar] plus lixisenatide', 'insulin glargine/lixisenatide (iGlarLixi) fixed-ratio combination']","['glycated hemoglobin A1C, fasting plasma glucose, postprandial glucose, weight, and achievement of A1C', 'Efficacy and safety', 'weight gain and lixisenatide-associated gastrointestinal events', 'A1C', 'efficacy and safety', 'severe hypoglycemia (requiring assistance of another person), and incidence of gastrointestinal adverse events', 'incidence of documented symptomatic hypoglycemia (defined as typical symptoms of hypoglycemia plus self-measured plasma glucose ≤70', 'glycemic control']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C2973895', 'cui_str': 'Lixisenatide'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0580836', 'cui_str': 'Old'}]","[{'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C2973895', 'cui_str': 'Lixisenatide'}, {'cui': 'C4293375', 'cui_str': 'insulin glargine and lixisenatide'}]","[{'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0017725', 'cui_str': 'Glucose'}, {'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C4521595', 'cui_str': 'US Military enlisted E3'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0043094', 'cui_str': 'Weight gain'}, {'cui': 'C2973895', 'cui_str': 'Lixisenatide'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C4728082', 'cui_str': 'Severe hypoglycaemia'}, {'cui': 'C1269765', 'cui_str': 'Assisted'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}, {'cui': 'C3539106', 'cui_str': 'Defined'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]",,0.0527392,"In both trials, older patients treated with iGlarLixi achieved significantly greater reductions in A1C at Week 30 than comparators.","[{'ForeName': 'Yehuda', 'Initials': 'Y', 'LastName': 'Handelsman', 'Affiliation': 'Metabolic Institute of America, 18372 Clark St. Suite 212, Tarzana, CA 91356, USA. Electronic address: yhandelsman@gmail.com.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Chovanes', 'Affiliation': 'Abington Memorial Hospital, 500 York Rd Suite 108, Jenkintown, PA 19046, USA. Electronic address: cchovane@gmail.com.'}, {'ForeName': 'Terry', 'Initials': 'T', 'LastName': 'Dex', 'Affiliation': 'Sanofi US, Inc., 55 Corporate Drive, Bridgewater, NJ 08807, USA. Electronic address: terry.dex@sanofi.com.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Giorgino', 'Affiliation': 'University of Bari Aldo Moro, Piazza Giulio Cesare 11, Bari 70124, Italy. Electronic address: francesco.giorgino@uniba.it.'}, {'ForeName': 'Neil', 'Initials': 'N', 'LastName': 'Skolnik', 'Affiliation': 'Abington Memorial Hospital, 500 York Rd Suite 108, Jenkintown, PA 19046, USA. Electronic address: nskolnik@comcast.net.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Souhami', 'Affiliation': 'Sanofi, 1 Avenue Pierre Brossolette, 91380 Chilly-Mazarin, France. Electronic address: elisabeth.souhami@sanofi.com.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Stager', 'Affiliation': 'Sanofi US, Inc., 55 Corporate Drive, Bridgewater, NJ 08807, USA. Electronic address: william-EXT.stager@sanofi.com.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Niemoeller', 'Affiliation': 'Sanofi Pasteur, K703, Industriepark Höchst, 65926 Frankfurt, Germany. Electronic address: elisabeth.niemoeller@sanofi.com.'}, {'ForeName': 'Juan Pablo', 'Initials': 'JP', 'LastName': 'Frias', 'Affiliation': 'National Research Institute, 2010 Wilshire Blvd #302, Los Angeles, 90057, CA, USA. Electronic address: juan.frias@nritrials.com.'}]",Journal of diabetes and its complications,['10.1016/j.jdiacomp.2018.11.009'] 2925,30729863,On the Popularity of Agentic and Communal Narcissists: The Tit-for-Tat Hypothesis.,"Among well-acquainted people, those high on agentic narcissism are less popular than those low on agentic narcissism. That popularity-difference figures prominently in the narcissism literature. But why are agentic narcissists less popular? We propose a novel answer-the tit-for-tat hypothesis. It states that agentic narcissists like other people less than non-narcissists do and that others reciprocate by liking agentic narcissists less in return. We also examine whether the tit-for-tat hypothesis generalizes to communal narcissism. A large round-robin study ( N = 474) assessed agentic and communal narcissism (Wave 1) and included two round-robin waves (Waves 2-3). The round-robin waves assessed participants' liking for all round-robin group members (2,488 informant-reports). The tit-for-tat hypothesis applied to agentic narcissists. It also applied to communal narcissists, albeit in a different way. Compared with non-narcissists, communal narcissists liked other people more and-in return-those others liked communal narcissists more. Our results elaborate on and qualify the thriving literature on narcissists' popularity.",2019,"Compared with non-narcissists, communal narcissists liked other people more and-in return-those others liked communal narcissists more.",[],[],[],[],[],[],,0.0160542,"Compared with non-narcissists, communal narcissists liked other people more and-in return-those others liked communal narcissists more.","[{'ForeName': 'Katrin', 'Initials': 'K', 'LastName': 'Rentzsch', 'Affiliation': '1 University of Bamberg, Germany.'}, {'ForeName': 'Jochen E', 'Initials': 'JE', 'LastName': 'Gebauer', 'Affiliation': '2 University of Mannheim, Germany.'}]",Personality & social psychology bulletin,['10.1177/0146167218824359'] 2926,30733167,Development and testing of a web-based battery to remotely assess cognitive health in individuals with schizophrenia.,"Cognitive impairment in schizophrenia is often severe, enduring, and contributes significantly to chronic disability. A standardized platform for identifying cognitive impairments and measuring treatment effects in cognition is a critical aspect of comprehensive evaluation and treatment for individuals with schizophrenia. In this project, we developed and tested a suite of ten web-based, neuroscience-informed cognitive assessments that are designed to enable the interpretation of specific deficits that could signal that an individual is experiencing cognitive difficulties. The assessment suite assays speed of processing, sustained attention, executive functioning, learning and socio-affective processing in the auditory and visual modalities. We have obtained data from 283 healthy individuals who were recruited online and 104 individuals with schizophrenia who also completed formal neuropsychological testing. Our data show that the assessments 1) are acceptable and tolerable to users, with successful completion in an average of under 40 min; 2) reliably measure the distinct theoretical cognitive constructs they were designed to assess; 3) can discriminate schizophrenia patients from healthy controls with a fair degree of accuracy (AUROC > 0.70); and 4) have promising construct, convergent, and external validity. Further optimization and validation work is in progress to finalize the evaluation process prior to promoting the dissemination of these assessments in real-world settings.",2019,"Our data show that the assessments 1) are acceptable and tolerable to users, with successful completion in an average of under 40 min; 2) reliably measure the distinct theoretical cognitive constructs they were designed to assess; 3) can discriminate schizophrenia patients from healthy controls with a fair degree of accuracy (AUROC > 0.70); and 4) have promising construct, convergent, and external validity.","['individuals with schizophrenia', '283 healthy individuals who were recruited online and 104 individuals with schizophrenia who also completed formal neuropsychological testing']",[],"['assessment suite assays speed of processing, sustained attention, executive functioning, learning and socio-affective processing in the auditory and visual modalities']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C4708786', 'cui_str': '283'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0027902', 'cui_str': 'Neuropsychological testing'}]",[],"[{'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0005507', 'cui_str': 'Bioassay'}, {'cui': 'C0025611', 'cui_str': 'Methamphetamine'}, {'cui': 'C0589099', 'cui_str': 'Sustained attention'}, {'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0439825', 'cui_str': 'Auditory'}, {'cui': 'C0234621', 'cui_str': 'Visual'}]",283.0,0.0269389,"Our data show that the assessments 1) are acceptable and tolerable to users, with successful completion in an average of under 40 min; 2) reliably measure the distinct theoretical cognitive constructs they were designed to assess; 3) can discriminate schizophrenia patients from healthy controls with a fair degree of accuracy (AUROC > 0.70); and 4) have promising construct, convergent, and external validity.","[{'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Biagianti', 'Affiliation': 'Posit Science, Inc., United States of America. Electronic address: bruno.biagianti@positscience.com.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Fisher', 'Affiliation': 'Department of Psychiatry, University of Minnesota, United States of America.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Brandrett', 'Affiliation': 'Department of Psychiatry, University of California, San Francisco, United States of America.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Schlosser', 'Affiliation': 'Department of Psychiatry, University of California, San Francisco, United States of America; Verily Life Sciences, United States of America.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Loewy', 'Affiliation': 'Department of Psychiatry, University of California, San Francisco, United States of America.'}, {'ForeName': 'Mor', 'Initials': 'M', 'LastName': 'Nahum', 'Affiliation': 'School of Occupational Therapy, Hebrew University of Jerusalem, Israel.'}, {'ForeName': 'Sophia', 'Initials': 'S', 'LastName': 'Vinogradov', 'Affiliation': 'Department of Psychiatry, University of Minnesota, United States of America.'}]",Schizophrenia research,['10.1016/j.schres.2019.01.047'] 2927,31171508,Evaluation of event-free survival as a robust end point in untreated acute myeloid leukemia (Alliance A151614).,"Event-free survival (EFS) is controversial as an end point for speeding approvals in newly diagnosed acute myeloid leukemia (AML). We aimed to examine the robustness of EFS, specifically timing of complete remission (CR) in defining induction failure and impact of hematopoietic cell transplantation (HCT). The study included 1884 untreated AML patients enrolled across 5 trials conducted through Alliance for Clinical Trials in Oncology using anthracycline and cytarabine induction chemotherapy. EFS was defined as time from randomization/registration to induction failure, relapse, or death. Three definitions of induction failure were evaluated: failure to achieve CR by 60 days after randomization/registration, failure to achieve CR by the end of all protocol-defined induction courses, and failure to achieve CR by the end of all protocol-defined treatment. We considered either censoring or no censoring at time of non-protocol-mandated HCT. Although relapse and death are firm end points, the determination of induction failure was not consistent across studies. There was minimal impact of censoring at HCT on EFS estimates; however, median EFS estimates differed considerably based on the timing of CR in defining induction failure, with the magnitude of difference being large enough in most cases to lead to incorrect conclusions about efficacy in a single-arm trial, if the trial definition was not consistent with the definition used for the historical control. Timing of CR should be carefully examined in the historical control data used to guide the design of single-arm trials using EFS as the primary end point. Trials were registered at www.clinicaltrials.gov as #NCT00085124, #NCT00416598, # NCT00651261, #NCT01238211, and #NCT01253070.",2019,"There was minimal impact of censoring at HCT on EFS estimates; however, median EFS estimates differed considerably based on the timing of CR in defining induction failure, with the magnitude of difference being large enough in most cases to lead to incorrect conclusions about efficacy in a single-arm trial, if the trial definition was not consistent with the definition used for the historical control.","['1884 untreated AML patients enrolled across 5 trials conducted through Alliance for Clinical Trials in Oncology using', 'newly diagnosed acute myeloid leukemia (AML']","['hematopoietic cell transplantation (HCT', 'anthracycline and cytarabine induction chemotherapy']",['Event-free survival (EFS'],"[{'cui': 'C0332155', 'cui_str': 'Did not receive therapy or drug for'}, {'cui': 'C0023467', 'cui_str': 'Acute myeloid leukemia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}]","[{'cui': 'C0472699', 'cui_str': 'Hemopoietic stem cell transplant'}, {'cui': 'C0003234', 'cui_str': 'Anthracycline'}, {'cui': 'C0010711', 'cui_str': 'Cytarabine'}, {'cui': 'C3179010', 'cui_str': 'Induction chemotherapy'}]","[{'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}]",1884.0,0.164404,"There was minimal impact of censoring at HCT on EFS estimates; however, median EFS estimates differed considerably based on the timing of CR in defining induction failure, with the magnitude of difference being large enough in most cases to lead to incorrect conclusions about efficacy in a single-arm trial, if the trial definition was not consistent with the definition used for the historical control.","[{'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Yin', 'Affiliation': 'Alliance Statistics and Data Center, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Betsy', 'Initials': 'B', 'LastName': 'LaPlant', 'Affiliation': 'Alliance Statistics and Data Center, Mayo Clinic, Rochester, MN.'}, {'ForeName': 'Geoffrey L', 'Initials': 'GL', 'LastName': 'Uy', 'Affiliation': 'Division of Oncology, Washington University School of Medicine, St. Louis, MO.'}, {'ForeName': 'Guido', 'Initials': 'G', 'LastName': 'Marcucci', 'Affiliation': 'City of Hope, Duarte, CA.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Blum', 'Affiliation': 'Department of Hematology and Medical Oncology, Emory University, Atlanta, GA.'}, {'ForeName': 'Richard A', 'Initials': 'RA', 'LastName': 'Larson', 'Affiliation': 'Comprehensive Cancer Center, University of Chicago, Chicago IL; and.'}, {'ForeName': 'Richard M', 'Initials': 'RM', 'LastName': 'Stone', 'Affiliation': 'Dana-Farber/Partners CancerCare, Boston, MA.'}, {'ForeName': 'Sumithra J', 'Initials': 'SJ', 'LastName': 'Mandrekar', 'Affiliation': 'Alliance Statistics and Data Center, Mayo Clinic, Rochester, MN.'}]",Blood advances,['10.1182/bloodadvances.2018026112'] 2928,31405927,Dopamine Enhances Item Novelty Detection via Hippocampal and Associative Recall via Left Lateral Prefrontal Cortex Mechanisms.,"The involvement of fronto-striatal circuits in item and associative memory retrieval as well as in the stabilization of memories by retrieval practice suggests that both retrieval and re-encoding of stored memories might rely on dopaminergic mechanisms in humans. We tested these hypotheses in a placebo-controlled pharmacological fMRI study using 2 mg of the D2 antagonist haloperidol administered acutely before a cued associative recall task of previously encoded picture-word pairs in 53 healthy humans of both sexes. The cued associative recall was moreover repeated 3 d later outside the scanner without pharmacological intervention. Dopaminergic modulation significantly improved associative recall performance and recognition accuracy of verbal items. Moreover, we observed a significant dopamine effect on re-encoding in terms of increased specificity of associative memories from the first to the second cued associative recall. Better association memory under haloperidol was linked with higher activity in the left lateral prefrontal cortex and right parietal cortex, suggesting that dopamine facilitates associative retrieval through increased recruitment of frontoparietal monitoring processes. In contrast, improved recognition of verbal items under haloperidol was reflected by enhanced novelty detection in the hippocampus and increased activity in saliency networks. Together, these results show distinct but concomitant positive effects of dopamine on associative recall and item recognition and suggest that the specificity of associative recall through re-encoding mechanisms is likewise augmented by dopamine. SIGNIFICANCE STATEMENT Although the neurotransmitter dopamine has been linked with learning and memory for a long time, dopaminergic effects on item recognition in humans were demonstrated only recently. The involvement of fronto-striatal monitoring processes in association retrieval suggests that associative memory might be particularly affected by dopamine. Moreover, fronto-striatal dopaminergic signals have been hypothesized to determine the updating and re-encoding of previously retrieved memories. We here demonstrate clear facilitative effects of dopamine on associative recall and item recognition mediated by prefrontal and hippocampal mechanisms respectively. Additionally, effects on re-encoding were reflected by increased specificity of associative memories. These results augment our understanding of dopaminergic processes in episodic memory retrieval and offer new perspectives on memory impairments in dopamine-related disorders and their treatment.",2019,"Better association memory under haloperidol was linked with higher activity in the left lateral prefrontal cortex and right parietal cortex, suggesting that dopamine facilitates associative retrieval through increased recruitment of frontoparietal monitoring processes.",['53 healthy humans of both sexes'],"['Dopamine', 'D2 antagonist haloperidol', 'haloperidol', 'dopamine', 'placebo']","['associative recall performance and recognition accuracy of verbal items', 'associative recall and item recognition', 'cued associative recall', 'specificity of associative memories', 'recognition of verbal items']","[{'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0009253', 'cui_str': 'Intercourse'}]","[{'cui': 'C0013030', 'cui_str': 'Dopamine'}, {'cui': 'C0231491', 'cui_str': 'Antagonist muscle action'}, {'cui': 'C0018546', 'cui_str': 'Haloperidol'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0034770', 'cui_str': 'Mental Recall'}, {'cui': 'C0524637', 'cui_str': 'Recognition'}, {'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0439824', 'cui_str': 'Verbal'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0037791', 'cui_str': 'Specificity'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}]",53.0,0.0214079,"Better association memory under haloperidol was linked with higher activity in the left lateral prefrontal cortex and right parietal cortex, suggesting that dopamine facilitates associative retrieval through increased recruitment of frontoparietal monitoring processes.","[{'ForeName': 'Mareike', 'Initials': 'M', 'LastName': 'Clos', 'Affiliation': 'Department of Systems Neuroscience, University Medical Center Hamburg-Eppendorf, 20246 Hamburg, Germany, and m.clos@uke.de.'}, {'ForeName': 'Nico', 'Initials': 'N', 'LastName': 'Bunzeck', 'Affiliation': 'Department of Systems Neuroscience, University Medical Center Hamburg-Eppendorf, 20246 Hamburg, Germany, and.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Sommer', 'Affiliation': 'Department of Systems Neuroscience, University Medical Center Hamburg-Eppendorf, 20246 Hamburg, Germany, and.'}]",The Journal of neuroscience : the official journal of the Society for Neuroscience,['10.1523/JNEUROSCI.0495-19.2019'] 2929,32619413,Laparoscopic ileocaecal resection versus infliximab for terminal ileitis in Crohn's disease: retrospective long-term follow-up of the LIR!C trial.,"BACKGROUND The LIR!C trial showed that laparoscopic ileocaecal resection is a cost-effective treatment that has similar quality-of-life outcomes to treatment with infliximab, an anti-tumour necrosis factor (TNF) drug. We aimed to compare long-term outcomes of both interventions and identify baseline factors associated with the duration of treatment effect in each group. METHODS In this retrospective follow-up study, we collected data from patients who participated in the LIR!C trial, a multicentre randomised controlled trial that compared quality of life after surgical resection versus infliximab in adult patients with non-stricturing and immunomodulator-refractory ileocaecal Crohn's disease. From Jan 1 to May 1, 2018, we collected follow-up data from the time from enrolment in the LIR!C trial until the last visit at either the gastrointestinal surgeon or gastroenterologist. In this study, outcomes of interest were need for surgery or repeat surgery or anti-TNF therapy, duration of treatment effect, and identification of factors associated with the duration of treatment effect. Duration of treatment effect was defined as the time without need for additional Crohn's disease-related treatment (corticosteroids, immunomodulators, biologics, or surgery). FINDINGS We collected long-term follow-up data for 134 (94%) of 143 patients included in the LIR!C trial, of whom 69 were in the resection group and 65 were in the infliximab group. Median follow-up was 63·5 months (IQR 39·0-94·5). In the resection group, 18 (26%) of 69 patients started anti-TNF therapy and none required a second resection. 29 (42%) patients in the resection group did not require additional Crohn's disease-related medication, although 14 (48%) of these patients were given prophylactic immunomodulator therapy. In the infliximab group, 31 (48%) of 65 patients had a Crohn's disease-related resection, and the remaining 34 patients maintained, switched, or escalated their anti-TNF therapy. Duration of treatment effect was similar in both groups, with a median time without additional Crohn's disease-related treatment of 33·0 months (95% CI 15·1-50·9) in the resection group and 34·0 months (0·0-69·3) in the infliximab group (log-rank p=0·52). In both groups, therapy with an immunomodulator, in addition to the allocated treatment, was associated with duration of treatment effect (hazard ratio for resection group 0·34 [95% CI 0·16-0·69] and for infliximab group 0·49 [0·26-0·93]). INTERPRETATION These findings further support laparoscopic ileocaecal resection as a treatment option in patients with Crohn's disease with limited (affected segment ≤40 cm) and predominantly inflammatory terminal ileitis for whom conventional treatment is not successful. FUNDING None.",2020,"Duration of treatment effect was similar in both groups, with a median time without additional Crohn's disease-related treatment of 33·0 months (95% CI 15·1-50·9) in the resection group and 34·0 months (0·0-69·3) in the infliximab group (log-rank p=0·52).","[""patients with Crohn's disease with limited (affected segment ≤40 cm"", '134 (94%) of 143 patients included in the LIR!C trial, of whom 69 were in the resection group and 65 were in the infliximab group', 'patients who participated in the LIR!C trial', ""Crohn's disease"", ""adult patients with non-stricturing and immunomodulator-refractory ileocaecal Crohn's disease""]","['infliximab', 'laparoscopic ileocaecal resection', 'surgical resection versus infliximab', 'Laparoscopic ileocaecal resection versus infliximab']","[""time without need for additional Crohn's disease-related treatment (corticosteroids, immunomodulators, biologics, or surgery"", 'Duration of treatment effect']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010346', 'cui_str': ""Crohn's disease""}, {'cui': 'C0439801', 'cui_str': 'Limited'}, {'cui': 'C0001721', 'cui_str': 'Affect'}, {'cui': 'C0441635', 'cui_str': 'Segment'}, {'cui': 'C4517565', 'cui_str': '134'}, {'cui': 'C4517573', 'cui_str': '143'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0015252', 'cui_str': 'Removal'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0666743', 'cui_str': 'infliximab'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001551', 'cui_str': 'Immunologic adjuvant'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0700426', 'cui_str': 'Ileocecal'}]","[{'cui': 'C0666743', 'cui_str': 'infliximab'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0400056', 'cui_str': 'Right hemicolectomy and end to end anastomosis of ileum to colon'}, {'cui': 'C0015252', 'cui_str': 'Removal'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0010346', 'cui_str': ""Crohn's disease""}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0001617', 'cui_str': 'Adrenal cortex hormone'}, {'cui': 'C0001551', 'cui_str': 'Immunologic adjuvant'}, {'cui': 'C0005515', 'cui_str': 'Biological agent'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0444921', 'cui_str': 'Duration of treatment'}, {'cui': 'C1280500', 'cui_str': 'Effect'}]",,0.135364,"Duration of treatment effect was similar in both groups, with a median time without additional Crohn's disease-related treatment of 33·0 months (95% CI 15·1-50·9) in the resection group and 34·0 months (0·0-69·3) in the infliximab group (log-rank p=0·52).","[{'ForeName': 'Toer W', 'Initials': 'TW', 'LastName': 'Stevens', 'Affiliation': 'Department of Gastroenterology and Hepatology, Amsterdam UMC, University of Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Maria L', 'Initials': 'ML', 'LastName': 'Haasnoot', 'Affiliation': 'Department of Gastroenterology and Hepatology, Amsterdam UMC, University of Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Geert R', 'Initials': 'GR', 'LastName': ""D'Haens"", 'Affiliation': 'Department of Gastroenterology and Hepatology, Amsterdam UMC, University of Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Christianne J', 'Initials': 'CJ', 'LastName': 'Buskens', 'Affiliation': 'Department of Surgery, Amsterdam UMC, University of Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'E Joline', 'Initials': 'EJ', 'LastName': 'de Groof', 'Affiliation': 'Department of Surgery, Amsterdam UMC, University of Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Emma J', 'Initials': 'EJ', 'LastName': 'Eshuis', 'Affiliation': 'Department of Gastroenterology and Hepatology, Amsterdam UMC, University of Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Tjibbe J', 'Initials': 'TJ', 'LastName': 'Gardenbroek', 'Affiliation': 'Department of Surgery, Amsterdam UMC, University of Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Bregje', 'Initials': 'B', 'LastName': 'Mol', 'Affiliation': 'Department of Gastroenterology and Hepatology, Amsterdam UMC, University of Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Pieter C F', 'Initials': 'PCF', 'LastName': 'Stokkers', 'Affiliation': 'Department of Gastroenterology and Hepatology, OLVG West, Amsterdam, Netherlands.'}, {'ForeName': 'Willem A', 'Initials': 'WA', 'LastName': 'Bemelman', 'Affiliation': 'Department of Surgery, Amsterdam UMC, University of Amsterdam, Amsterdam, Netherlands. Electronic address: w.a.bemelman@amsterdamumc.nl.'}, {'ForeName': 'Cyriel Y', 'Initials': 'CY', 'LastName': 'Ponsioen', 'Affiliation': 'Department of Gastroenterology and Hepatology, Amsterdam UMC, University of Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The lancet. Gastroenterology & hepatology,['10.1016/S2468-1253(20)30117-5'] 2930,32619458,"Acute psychological stress, autonomic function, and arterial stiffness among women.","This study aimed to investigate the effect of acute psychological stress on autonomic function and arterial stiffness, and to test a mediating role of change in autonomic function between acute stress and arterial stiffness. Eighty-five healthy female adults were randomized into either an experimental or control group. The Trier Social Stress Test (TSST) was used to induce acute psychological stress. Autonomic function (measured by pre-ejection period [PEP] from cardiac impedance and high frequency [HF] of heart rate variability [HRV]) and arterial stiffness (measured by carotid and femoral pulse wave velocity [cfPWV] and augmentation index [AIx]) were assessed before and after the TSST. The mean age of the participants was 28.78 (±9.84) years old. Experimental group participants had a significant increase in cfPWV (p = .025) and AIx (p = .017) following the stressor, compared with those in the control group, after controlling for age, body mass index, and systolic blood pressure. However, no significant group differences were observed in changes in PEP (p = .181) and HF (p = .058). Changes in PEP and HF were neither associated with changes in cfPWV (p = .975 and p = .654, respectively), nor in AIx (p = .376 and p = .323, respectively). The results suggest that even a brief period of mild to moderate stress, which does not cause sustainable change in autonomic function, may still exert significant adverse effects on arterial stiffness. The changes in arterial stiffness were not related to changes in autonomic function. Future experimental studies with several measurement points are recommended to identify distinct effects of stress on autonomic function and arterial stiffness.",2020,"Experimental group participants had a significant increase in cfPWV (p = .025) and AIx (p = .017) following the stressor, compared with those in the control group, after controlling for age, body mass index, and systolic blood pressure.","['The mean age of the participants was 28.78 (±9.84) years old', 'Eighty-five healthy female adults', 'women']",['Trier Social Stress Test (TSST'],"['heart rate variability [HRV]) and arterial stiffness (measured by carotid and femoral pulse wave velocity [cfPWV] and augmentation index [AIx', 'cfPWV', 'Autonomic function', 'Acute psychological stress, autonomic function, and arterial stiffness', 'arterial stiffness', 'autonomic function and arterial stiffness', 'systolic blood pressure', 'autonomic function', 'changes in PEP']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C4517892', 'cui_str': '85'}, {'cui': 'C0686752', 'cui_str': 'Well female adult'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0065404', 'cui_str': 'lysyl-5-fluorotryptophyl-lysine'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}]","[{'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0599949', 'cui_str': 'Arterial stiffness'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0232148', 'cui_str': 'Femoral pulse'}, {'cui': 'C0034519', 'cui_str': 'Electromagnetic radiation'}, {'cui': 'C0439830', 'cui_str': 'Velocity'}, {'cui': 'C0332509', 'cui_str': 'Increased size'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0999177', 'cui_str': 'Aix'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0205178', 'cui_str': 'Acuteness'}, {'cui': 'C0038443', 'cui_str': 'Psychological Stress'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0392747', 'cui_str': 'Changing'}, {'cui': 'C0031642', 'cui_str': 'Phosphoenolpyruvate'}]",85.0,0.0168326,"Experimental group participants had a significant increase in cfPWV (p = .025) and AIx (p = .017) following the stressor, compared with those in the control group, after controlling for age, body mass index, and systolic blood pressure.","[{'ForeName': 'Jeongok', 'Initials': 'J', 'LastName': 'Logan', 'Affiliation': 'University of Virginia, School of Nursing, McLeod Hall 4011, 202 Jeanette Lancaster Way, Charlottesville, VA 22903, United States. Electronic address: jl3zj@virginia.edu.'}, {'ForeName': 'Bethany', 'Initials': 'B', 'LastName': 'Teachman', 'Affiliation': 'University of Virginia, Department of Psychology, 207 Gilmer Hall, Charlottesville, VA 22903, United States. Electronic address: bat5x@virginia.edu.'}, {'ForeName': 'Xiaoyue', 'Initials': 'X', 'LastName': 'Liu', 'Affiliation': 'University of Virginia, School of Nursing, McLeod Hall 4034, 202 Jeanette Lancaster Way, Charlottesville, VA 22903, United States. Electronic address: xl5tb@virginia.edu.'}, {'ForeName': 'Charles R', 'Initials': 'CR', 'LastName': 'Farber', 'Affiliation': 'University of Virginia, Public Health Sciences, OMS 3817B, Charlottesville, VA 22908, United States. Electronic address: crf2s@virginia.edu.'}, {'ForeName': 'Zhenqi', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': 'University of Virginia, School of Medicine, Suite 2100, 450 Ray C. Hunt Drive, Charlottesville, VA 22903, United States. Electronic address: zl3e@virginia.edu.'}, {'ForeName': 'Brian H', 'Initials': 'BH', 'LastName': 'Annex', 'Affiliation': 'Augusta University, Medical College of Georgia, 1120 15th St. Augusta, GA 30912, United States. Electronic address: bannex@augusta.edu.'}]",International journal of psychophysiology : official journal of the International Organization of Psychophysiology,['10.1016/j.ijpsycho.2020.06.015'] 2931,32619524,Design of a Randomized Placebo Controlled Trial of High Dose Intravenous Thiamine for the Prevention of Delirium in Allogeneic Hematopoietic Stem Cell Transplantation.,"BACKGROUND Delirium is a highly prevalent and preventable neuropsychiatric condition with major health consequences. Thiamine deficiency is a well-established cause of delirium in those with chronic, severe alcoholism, but there remains an underappreciation of its significance in non-alcoholic populations, including patients with cancer. Treatment of suspected thiamine-related mental status changes with high dose intravenous (IV) thiamine has preliminary evidence for improving a variety of cognitive symptoms in oncology inpatient settings but has never been studied for the prevention of delirium in any population. OBJECTIVES The primary objective of this clinical trial is to determine if high dose IV thiamine can prevent delirium in patients receiving allogeneic hematopoietic stem cell transplantation (HSCT) for treatment of cancer. Secondary objectives are to determine if thiamine status is predictive of delirium onset and if high dose IV thiamine can attenuate the deleterious impact of delirium on health-related quality of life (HRQOL), functional status, and long-term neuropsychiatric outcomes. METHODS In this phase II study, we are recruiting 60 patients undergoing allogeneic HSCT, randomizing them to treatment with high dose IV thiamine (n = 30) versus placebo (n = 30), and systematically evaluating all participants for delirium and related comorbidities. We use the Delirium Rating Scale to measure the severity and duration of delirium during hospitalization for HSCT. We obtain thiamine levels weekly during the transplantation hospitalization. We assess HRQOL, functional status, depression, post-traumatic stress symptoms, and cognitive function prior to and at one, three, and six months after transplantation.",2020,"Treatment of suspected thiamine-related mental status changes with high dose intravenous (IV) thiamine has preliminary evidence for improving a variety of cognitive symptoms in oncology inpatient settings but has never been studied for the prevention of delirium in any population. ","['60 patients undergoing allogeneic HSCT, randomizing them to treatment with high dose', 'patients receiving allogeneic hematopoietic stem cell transplantation (HSCT) for treatment of cancer', 'Allogeneic Hematopoietic Stem Cell Transplantation', 'patients with cancer']","['Placebo', 'Thiamine', 'thiamine', 'intravenous (IV) thiamine', 'IV thiamine', 'placebo']","['HRQOL, functional status, depression, post-traumatic stress symptoms, and cognitive function', 'Delirium Rating Scale', 'health-related quality of life (HRQOL), functional status, and long-term neuropsychiatric outcomes']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0472699', 'cui_str': 'Hemopoietic stem cell transplant'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}]","[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0039840', 'cui_str': 'Thiamine'}, {'cui': 'C0348016', 'cui_str': 'Intravenous'}]","[{'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0332663', 'cui_str': 'Traumatic'}, {'cui': 'C0521991', 'cui_str': 'Symptoms of stress'}, {'cui': 'C0009240', 'cui_str': 'Cognitive Function'}, {'cui': 'C0011206', 'cui_str': 'Delirium'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C1274040', 'cui_str': 'Result'}]",60.0,0.367689,"Treatment of suspected thiamine-related mental status changes with high dose intravenous (IV) thiamine has preliminary evidence for improving a variety of cognitive symptoms in oncology inpatient settings but has never been studied for the prevention of delirium in any population. ","[{'ForeName': 'Zev M', 'Initials': 'ZM', 'LastName': 'Nakamura', 'Affiliation': 'Department of Psychiatry, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA; Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA. Electronic address: zev_nakamura@med.unc.edu.'}, {'ForeName': 'Allison M', 'Initials': 'AM', 'LastName': 'Deal', 'Affiliation': 'Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Donald L', 'Initials': 'DL', 'LastName': 'Rosenstein', 'Affiliation': 'Department of Psychiatry, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA; Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA; Department of Medicine, Division of Hematology/Oncology, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Laura J', 'Initials': 'LJ', 'LastName': 'Quillen', 'Affiliation': 'Department of Psychiatry, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Stephanie A', 'Initials': 'SA', 'LastName': 'Chien', 'Affiliation': 'Department of Psychiatry, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'William A', 'Initials': 'WA', 'LastName': 'Wood', 'Affiliation': 'Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA; Department of Medicine, Division of Hematology/Oncology, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Thomas C', 'Initials': 'TC', 'LastName': 'Shea', 'Affiliation': 'Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA; Department of Medicine, Division of Hematology/Oncology, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}, {'ForeName': 'Eliza M', 'Initials': 'EM', 'LastName': 'Park', 'Affiliation': 'Department of Psychiatry, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA; Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA; Department of Medicine, Division of Hematology/Oncology, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106076'] 2932,32619525,Modulation of Startle and Heart Rate Responses by Fear of Physical Activity in Patients with Heart Failure and in Healthy Adults.,"Fear of physical activity (FoPA) is prevalent in patients with heart failure and associated with lower physical activity despite medical exercise prescriptions. The present study examined physiological indicators of FoPA by assessing startle modulation and heart rate responses after affective priming with lexical stimuli of positive, neutral, and negative valence, as well as words related to physical activity as potentially phobic cues. After screening for FoPA in patients with heart failure and healthy adults, twenty participants each were assigned to one of three subsamples: a healthy control group and two cardiac patient groups scoring either low or high on FoPA. The high-FoPA group showed more pronounced startle potentiation and heart rate acceleration (i.e., mobilization of defensive behavior) in the phobic prime condition compared to controls. Differences in FoPA accounted for 30% of the startle potentiation by phobic priming, whereas general anxiety, depression, and disease severity were no significant predictors in patients with heart failure. These findings suggest that heart failure-associated FoPA elicits avoidance behavior at a largely automatic level, and might thereby contribute to low adherence to exercise regimen. Thus, FoPA should be addressed in the design of psychological interventions for cardiac patients to foster physical activity.",2020,"Differences in FoPA accounted for 30% of the startle potentiation by phobic priming, whereas general anxiety, depression, and disease severity were no significant predictors in patients with heart failure.","['patients with heart failure', 'patients with heart failure and associated with lower physical activity despite medical exercise prescriptions', 'patients with heart failure and healthy adults, twenty participants each', 'Patients with Heart Failure and in Healthy Adults']","['Fear of physical activity (FoPA', 'FoPA', 'healthy control group and two cardiac patient groups scoring either low or high on FoPA']","['startle potentiation and heart rate acceleration (i.e., mobilization of defensive behavior', 'general anxiety, depression, and disease severity']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0588464', 'cui_str': 'Exercise on prescription'}, {'cui': 'C0686750', 'cui_str': 'Well adult'}]","[{'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0018787', 'cui_str': 'Heart structure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0205250', 'cui_str': 'High'}]","[{'cui': 'C0086188', 'cui_str': 'Drug Potentiation'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0000894', 'cui_str': 'Acceleration'}, {'cui': 'C0185112', 'cui_str': 'Mobilization'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0439793', 'cui_str': 'Severities'}]",20.0,0.0134447,"Differences in FoPA accounted for 30% of the startle potentiation by phobic priming, whereas general anxiety, depression, and disease severity were no significant predictors in patients with heart failure.","[{'ForeName': 'Jeremia Mark', 'Initials': 'JM', 'LastName': 'Hoffmann', 'Affiliation': 'Division of Health Psychology, Department of Nursing Science, Trier University, Universitätsring 15, D-54286 Trier, Germany.'}, {'ForeName': 'Johannes B', 'Initials': 'JB', 'LastName': 'Finke', 'Affiliation': 'Department of Clinical Psychology, University of Siegen, Adolf-Reichwein-Straße 2a, D-57076 Siegen, Germany; Institute of Psychobiology, Department of Clinical Psychophysiology, Trier University, Johanniterufer 15, D-54290 Trier, Germany.'}, {'ForeName': 'Hartmut', 'Initials': 'H', 'LastName': 'Schächinger', 'Affiliation': 'Institute of Psychobiology, Department of Clinical Psychophysiology, Trier University, Johanniterufer 15, D-54290 Trier, Germany.'}, {'ForeName': 'André', 'Initials': 'A', 'LastName': 'Schulz', 'Affiliation': 'Institute for Health and Behaviour, Department of Behavioural and Cognitive Sciences, University of Luxembourg, 11, Porte des Sciences, L-4366 Esch-sur-Alzette, Luxembourg.'}, {'ForeName': 'Claus', 'Initials': 'C', 'LastName': 'Vögele', 'Affiliation': 'Institute for Health and Behaviour, Department of Behavioural and Cognitive Sciences, University of Luxembourg, 11, Porte des Sciences, L-4366 Esch-sur-Alzette, Luxembourg.'}, {'ForeName': 'Heike', 'Initials': 'H', 'LastName': 'Spaderna', 'Affiliation': 'Division of Health Psychology, Department of Nursing Science, Trier University, Universitätsring 15, D-54286 Trier, Germany. Electronic address: spaderna@uni-trier.de.'}]",Physiology & behavior,['10.1016/j.physbeh.2020.113044'] 2933,32619648,Impact of compliance to chemoradiation on long-term outcomes in squamous cell carcinoma of the anus. Results of a post-hoc analysis from the randomized phase III ACT II trial.,"PURPOSE Concurrent chemoradiation is standard-of-care for patients with squamous cell carcinoma of the anus (SCCA). Poor compliance to chemotherapy, radiotherapy treatment interruptions and unplanned breaks may impact adversely on long-term outcomes. METHODS The ACT II trial recruited 940 patients with localized SCCA, and assigned patients to mitomycin (week 1) or cisplatin (weeks 1 and 5), with fluorouracil (weeks 1 & 5) and radiotherapy (50·4Gy in 28 fractions over 38 days). This post-hoc analysis examined the association between baseline factors (age, gender, site, T-stage and N-stage), and compliance to treatment (radiotherapy and chemotherapy), and their effects on loco-regional failure-free survival (LRFFS), progression-free survival (PFS) and overall survival (OS). Compliance was categorized into groups. Radiotherapy: 6 groups according to total dose (TD) and overall treatment time (OTT). Chemotherapy: 3 groups (A = per-protocol; B = dose reduction or delay; C = omitted). RESULTS 931/940 patients were evaluable for radiotherapy and 936 for chemotherapy compliance. Baseline Glomerular filtration rate (GR) <60 mL/min and cisplatin were significantly associated with poor week 5 compliance to chemotherapy (p 0.003 and 0.02, respectively). Omission of week 5 chemotherapy was associated with significantly worse LRFFS (HR 2.53 [1.33 to 4.82] p=0.005). Dose reductions/delays or omission of week 5 chemotherapy were associated with significantly worse FPFS (HR: 1.56 [95%CI: 1.18-2.06], p=0.002 and HR: 2.39 [95%CI: 1.44-3.98}, p=0.001, respectively) and OS (HR: 1.92 [95%CI: 1.41-2.63], p<0.001 and (HR: 2.88 [95%CI: 1.63-5.08], p<0.001, respectively). Receiving the target radiotherapy dose in >42 days is associated with worse PFS and OS (HR:1.72 (95%CI:1.17-2.54), p=0.006). CONCLUSION Poor compliance to chemotherapy and radiotherapy were associated with worse LRFFS, PFS and OS. Treatment interruptions should be minimized, and OTT and TD maintained.",2020,"<60 mL/min and cisplatin were significantly associated with poor week 5 compliance to chemotherapy (p 0.003 and 0.02, respectively).","['patients with squamous cell carcinoma of the anus (SCCA', '940 patients with localized SCCA, and assigned patients to', 'squamous cell carcinoma of the anus', '931/940 patients were evaluable for radiotherapy and 936 for chemotherapy compliance']","['Chemotherapy', 'chemotherapy and radiotherapy', 'fluorouracil', 'chemotherapy, radiotherapy', 'cisplatin', 'mitomycin', 'radiotherapy (50·4Gy', 'Radiotherapy']","['worse PFS and OS', 'total dose (TD) and overall treatment time (OTT', 'loco-regional failure-free survival (LRFFS), progression-free survival (PFS) and overall survival (OS', 'Baseline Glomerular filtration rate (GR']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1412036', 'cui_str': 'Anal squamous cell carcinoma'}, {'cui': 'C4517905', 'cui_str': '940'}, {'cui': 'C1516050', 'cui_str': 'Assigned'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0009563', 'cui_str': 'Compliance'}]","[{'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0002475', 'cui_str': 'Mitomycin'}]","[{'cui': 'C0053267', 'cui_str': ""benzoylamido-4'-aminostilbene-2,2'-disulfonate""}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0205147', 'cui_str': 'Regional'}, {'cui': 'C0231174', 'cui_str': 'Failure'}, {'cui': 'C0332296', 'cui_str': 'Free of'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0017654', 'cui_str': 'Glomerular filtration rate'}]",940.0,0.148641,"<60 mL/min and cisplatin were significantly associated with poor week 5 compliance to chemotherapy (p 0.003 and 0.02, respectively).","[{'ForeName': 'R', 'Initials': 'R', 'LastName': 'Glynne-Jones', 'Affiliation': 'Mount Vernon Centre for Cancer Treatment, Mount Vernon Hospital, Northwood, UK. Electronic address: rob.glynnejones@nhs.net.'}, {'ForeName': 'H M', 'Initials': 'HM', 'LastName': 'Meadows', 'Affiliation': 'Cancer Research UK & University College London Cancer Trials Centre, UCL, London, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Lopes', 'Affiliation': 'Cancer Research UK & University College London Cancer Trials Centre, UCL, London, UK.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Muirhead', 'Affiliation': 'Oxford Cancer & Haematology Centre, Oxford University Hospitals, Oxford, UK.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Sebag-Montefiore', 'Affiliation': 'University of Leeds, Leeds Cancer Centre, Leeds, UK.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Adams', 'Affiliation': 'School of Medicine, Cardiff University, Cardiff, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1016/j.annonc.2020.06.012'] 2934,32619656,Endoscopic debridement for non-insertional Achilles tendinopathy with and without platelet-rich plasma.,"BACKGROUND When non-operative management fails to improve symptoms in patients with non-insertional Achilles tendinopathy, surgery may be required. Various open and endoscopic techniques have been proposed, and platelet-rich plasma (PRP) injections have been proposed as an adjunct to aid tendon healing. METHODS Thirty-six patients with mid-portion Achilles tendinopathy were randomized to undergo endoscopic debridement alone (n = 19) or in combination with intraoperative PRP application (n = 17). Clinical outcome measures included the Visual Analogue Scale (VAS) for pain, function and satisfaction and the VISA-A questionnaire (Victorian Institute of Sports Assessment - Achilles). Patients were followed up at 6 weeks, 3 months, 6 months and 12 months after surgery. An MRI examination at 3 and 12 months was used to assess signal alterations within the tendon. RESULTS Both groups showed significant clinical improvement (p < 0.05) after surgery, with no difference between the 2 groups. Tendon diameter increased at 3 months and decreased at 12 months. The tendinopathy area increased at 3 months and decreased at 12 months below baseline level in both groups. There was no significant difference between the groups regarding the MRI parameters. Nodular thickening and MRI-detected signal alteration persisted after surgery, with no association between imaging and clinical outcome. Five minor complications were reported: 2 in the PRP group and 3 in the control group. CONCLUSION Endoscopic debridement of the Achilles tendon improved clinical outcomes in patients with mid-portion tendinopathy. The addition of PRP did not improve outcomes compared to debridement alone. MRI parameters showed no association with clinical outcomes.",2020,"Both groups showed significant clinical improvement (p < 0.05) after surgery, with no difference between the 2 groups.","['patients with mid-portion tendinopathy', 'patients with non-insertional Achilles tendinopathy', 'Thirty-six patients with mid-portion Achilles tendinopathy']","['Endoscopic debridement', 'PRP', 'endoscopic debridement alone (n\u202f=\u202f19) or in combination with intraoperative PRP application']","['clinical outcomes', 'MRI parameters', 'Tendon diameter', 'Visual Analogue Scale (VAS) for pain, function and satisfaction and the VISA-A questionnaire (Victorian Institute of Sports Assessment - Achilles', 'tendinopathy area', 'Nodular thickening and MRI-detected signal alteration']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0444598', 'cui_str': 'Mid'}, {'cui': 'C0449719', 'cui_str': 'Part'}, {'cui': 'C0151936', 'cui_str': 'Disorder of tendon'}, {'cui': 'C3838916', 'cui_str': 'Non-insertional Achilles tendinopathy'}, {'cui': 'C4319606', 'cui_str': '36'}, {'cui': 'C0001074', 'cui_str': 'Structure of Achilles tendon'}]","[{'cui': 'C0014245', 'cui_str': 'Endoscopy'}, {'cui': 'C0011079', 'cui_str': 'Debridement'}, {'cui': 'C0370220', 'cui_str': 'Platelet rich plasma'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0185125', 'cui_str': 'Application'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0024485', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0039508', 'cui_str': 'Tendon structure'}, {'cui': 'C1301886', 'cui_str': 'Diameter'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C1318881', 'cui_str': 'Infection due to vancomycin intermediate Staphylococcus aureus'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C0038039', 'cui_str': 'Sport'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0001074', 'cui_str': 'Structure of Achilles tendon'}, {'cui': 'C0151936', 'cui_str': 'Disorder of tendon'}, {'cui': 'C0017446', 'cui_str': 'Geographic Locations'}, {'cui': 'C0205297', 'cui_str': 'Nodular'}, {'cui': 'C0205400', 'cui_str': 'Thickened'}, {'cui': 'C0442726', 'cui_str': 'Detected'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}]",36.0,0.0569791,"Both groups showed significant clinical improvement (p < 0.05) after surgery, with no difference between the 2 groups.","[{'ForeName': 'Hajo', 'Initials': 'H', 'LastName': 'Thermann', 'Affiliation': 'HKF-International Center for Hip, Foot and Knee Surgery, Bismarckstraße 9-15, 69115 Heidelberg, Germany.'}, {'ForeName': 'Ralph', 'Initials': 'R', 'LastName': 'Fischer', 'Affiliation': 'HKF-International Center for Hip, Foot and Knee Surgery, Bismarckstraße 9-15, 69115 Heidelberg, Germany.'}, {'ForeName': 'Nikolaos', 'Initials': 'N', 'LastName': 'Gougoulias', 'Affiliation': 'Footsurgery Clinic, 54631 Thessaloniki, Greece.'}, {'ForeName': 'Lucio', 'Initials': 'L', 'LastName': 'Cipollaro', 'Affiliation': 'Department of Musculoskeletal Disorders, Faculty of Medicine and Surgery, University of Salerno, Salerno 89100, Italy; Department of Medicine, Surgery and Dentistry, University of Salerno, Via S. Allende, 84081 Baronissi (SA), Italy.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Maffulli', 'Affiliation': 'Department of Musculoskeletal Disorders, Faculty of Medicine and Surgery, University of Salerno, Salerno 89100, Italy; Department of Medicine, Surgery and Dentistry, University of Salerno, Via S. Allende, 84081 Baronissi (SA), Italy; Centre for Sports and Exercise Medicine, Barts and The London School of Medicine and Dentistry, Mile End Hospital, 275 Bancroft Road, London E1 4DG, Queen Mary University of London, London, UK; School of Pharmacy and Bioengineering, Keele University Faculty of Medicine, Thornburrow Drive, Stoke on Trent, UK. Electronic address: n.maffulli@qmul.ac.uk.'}]",Journal of sport and health science,['10.1016/j.jshs.2020.06.012'] 2935,32619694,Alpha Frequency rTMS Modulates Theta Lagged Nonlinear Connectivity in Dorsal Attention Network.,"Dorsolateral prefrontal cortex (DLPFC) is a key structure in the dorsal attention network (DAN) that facilitates sustained attention by modulating the activity in task related and unrelated regions of the brain. Alpha and theta frequency bands enhance connectivity of different parts of the attention network and these connections are facilitated by long-range nonlinear connectivity in theta and alpha frequency bands. This study is an investigation of the behavioral and network effects of alpha and theta repetitive transcranial magnetic stimulation (rTMS) over RDLPFC. 20 healthy participants were randomly assigned to two groups of theta (n = 11, f = 10 Hz) and alpha (n = 9, f = 6 Hz) rTMS. Electroencephalogram (EEG) was recorded before and after each session while resting and performing tasks. Current source density (CSD) and functional connectivity (FC) in DAN and default mode network (DMN) and their correlations with rapid visual information processing task (RVIP) scores were conducted by eLORETA. Alpha frequency rTMS resulted in significant changes in RVIP scores. Active theta rTMS caused an increase in CSD in Postcentral gyrus and active alpha rTMS resulted in significant CSD changed in inferior parietal lobule (IPL). Active alpha rTMS resulted in the modulation of theta lagged nonlinear connectivity. FC changes were observed in DAN and DMN. Positive correlations were observed between DAN regions and RVIP scores in the alpha rTMS group. Increased activity in theta frequency band in left aPFC and left DLPFC correlated positively with higher total hits in RVIP. This study showed for the first time that theta and alpha frequency rTMS is able to modulate FC in DAN and DMN in a way that results in better performance in a sustained attention task.",2020,Active theta rTMS caused an increase in CSD in Postcentral gyrus and active alpha rTMS resulted in significant CSD changed in inferior parietal lobule (IPL).,['20 healthy participants'],"['alpha and theta repetitive transcranial magnetic stimulation (rTMS', 'Alpha Frequency rTMS', 'Active alpha rTMS', 'alpha (n\u2009=\u20099, f\u2009=\u20096\u2009Hz) rTMS']","['rapid visual information processing task (RVIP) scores', 'Electroencephalogram (EEG', 'RVIP scores', 'FC changes', 'CSD', 'Current source density (CSD) and functional connectivity (FC']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0439095', 'cui_str': 'Alpha'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0205177', 'cui_str': 'Active'}]","[{'cui': 'C0456962', 'cui_str': 'Rapid'}, {'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C0021420', 'cui_str': 'Information Processing'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0013819', 'cui_str': 'Electroencephalogram'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0449416', 'cui_str': 'Source'}, {'cui': 'C0178587', 'cui_str': 'Density'}]",20.0,0.0387473,Active theta rTMS caused an increase in CSD in Postcentral gyrus and active alpha rTMS resulted in significant CSD changed in inferior parietal lobule (IPL).,"[{'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Kazemi', 'Affiliation': 'Cognitive lab, Department of Psychology, University of Tehran, Tehran, Iran; Atieh Clinical Neuroscience Center, Tehran, Iran. Electronic address: rezakazemi@ut.ac.ir.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Rostami', 'Affiliation': 'Department of Psychology, University of Tehran, Tehran, Iran.'}, {'ForeName': 'Shouka', 'Initials': 'S', 'LastName': 'Dehghan', 'Affiliation': 'Atieh Clinical Neuroscience Center, Tehran, Iran.'}, {'ForeName': 'Zahra', 'Initials': 'Z', 'LastName': 'Nasiri', 'Affiliation': 'Atieh Clinical Neuroscience Center, Tehran, Iran.'}, {'ForeName': 'Solmaz', 'Initials': 'S', 'LastName': 'Lotfollahzadeh', 'Affiliation': 'Atieh Clinical Neuroscience Center, Tehran, Iran.'}, {'ForeName': 'Abed L', 'Initials': 'AL', 'LastName': 'Hadipour', 'Affiliation': 'Department of Psychology, University of Tehran, Tehran, Iran.'}, {'ForeName': 'Sanaz', 'Initials': 'S', 'LastName': 'Khomami', 'Affiliation': 'Atieh Clinical Neuroscience Center, Tehran, Iran.'}, {'ForeName': 'Ryouhei', 'Initials': 'R', 'LastName': 'Ishii', 'Affiliation': 'Smart Rehabilitation Research Center, Osaka Prefecture University Graduate School of Comprehensive Rehabilitation, Habikino, Japan; Department of Psychiatry, Osaka University Graduate School of Medicine, Osaka, Japan.'}, {'ForeName': 'Shunichiro', 'Initials': 'S', 'LastName': 'Ikeda', 'Affiliation': 'Department of Neuropsychiatry, Kansai Medical University, Osaka, Japan.'}]",Brain research bulletin,['10.1016/j.brainresbull.2020.06.018'] 2936,32619713,Three Photobiomodulation Protocols in the Prevention/Treatment of Radiotherapy-induced Oral Mucositis.,"PURPOSE To compare three Photobiomodulation protocols to prevent/treat oral mucositis associated to radiotherapy. METHODS Seventy-three patients with cancer in oral cavity, oropharynx, and nasopharynx, who underwent RT with dose in facial fields equal or higher than 6000 cGy were randomized into three groups (mean RT dose = 66 cGy ±4.9). Protocols of Group 1 was 660 nm, 15 mW, 3.8 J/cm2, Group 2 660 nm, 25 mW, 6.3 J/cm2 both starting on the first day of radiotherapy, and group 3 660 nm, 15 mW, 3.8 J/cm2 for therapeutic purpose. The patients of group 1 and 2 were irradiated at 40 points daily covering non-keratinizing oral mucosa. The spot size (probe's tip surface size) was 0.040 cm2 for all groups. Oral mucositis was evaluated according to both WHO and NCI scales, and pain related to oral mucositis was scored using the VAS. RESULTS Patients from group 1 presented with grade II oral mucositis later than groups 2 and 3 (p < 0.001). Moreover, groups 2 and 3 also presented with a mean higher of oral mucositis grade than group 1, p < 0.001. Pain scores were lower in group 1 (p = 0.002). CONCLUSIONS The Photobiomodulation used in Group 1 was more effective than the protocols used in groups 2 and 3 in controlling the grade II oral mucositis intensity, and mean pain scores.",2020,"Pain scores were lower in group 1 (p = 0.002). ","['Seventy-three patients with cancer in oral cavity, oropharynx, and nasopharynx, who underwent RT with dose in facial fields equal or higher than 6000 cGy']",['Radiotherapy-induced Oral Mucositis'],"['grade II oral mucositis intensity, and mean pain scores', 'Oral mucositis', 'oral mucositis grade', 'WHO and NCI scales, and pain related to oral mucositis', 'grade II oral mucositis', 'Pain scores']","[{'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0521367', 'cui_str': 'Oropharyngeal structure'}, {'cui': 'C0027442', 'cui_str': 'Nasopharyngeal'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0440042', 'cui_str': ""Field's stain""}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C3842326', 'cui_str': '6000'}, {'cui': 'C0556645', 'cui_str': 'cGy'}]","[{'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0038362', 'cui_str': 'Stomatitis'}]","[{'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0038362', 'cui_str': 'Stomatitis'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C0560007', 'cui_str': 'nCi'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]",73.0,0.0145844,"Pain scores were lower in group 1 (p = 0.002). ","[{'ForeName': 'Paulo André Gonçalves', 'Initials': 'PAG', 'LastName': 'de Carvalho', 'Affiliation': 'Stomatology Department- A.C. Camargo Cancer Center, Sao Paulo, Brazil.'}, {'ForeName': 'Roberta Cardim', 'Initials': 'RC', 'LastName': 'Lessa', 'Affiliation': 'Stomatology Department- A.C. Camargo Cancer Center, Sao Paulo, Brazil.'}, {'ForeName': 'Dirce Maria', 'Initials': 'DM', 'LastName': 'Carraro', 'Affiliation': 'Laboratory of Genomics and Molecular Biology, International Research Center/CIPE, Brazil.'}, {'ForeName': 'Antonio Cássio', 'Initials': 'AC', 'LastName': 'Assis Pellizzon', 'Affiliation': 'Radiotherapy Department- A.C. Camargo Cancer Center, Sao Paulo, Brazil.'}, {'ForeName': 'Graziella Chagas', 'Initials': 'GC', 'LastName': 'Jaguar', 'Affiliation': 'Stomatology Department- A.C. Camargo Cancer Center, Sao Paulo, Brazil.'}, {'ForeName': 'Fábio Abreu', 'Initials': 'FA', 'LastName': 'Alves', 'Affiliation': 'Stomatology Department- A.C. Camargo Cancer Center, Sao Paulo, Brazil; Stomatology Department School of Dentistry, Sao Paulo University, Sao Paulo, Brazil. Electronic address: falves@accamargo.org.br.'}]",Photodiagnosis and photodynamic therapy,['10.1016/j.pdpdt.2020.101906'] 2937,32621737,Erratum to: Merely Possessing a Placebo Analgesic Improves Analgesia Similar to Using the Placebo Analgesic.,,2020,,[],['Placebo Analgesic'],[],[],"[{'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0002771', 'cui_str': 'Analgesic'}]",[],,0.24603,,"[{'ForeName': 'Victoria Wai-Lan', 'Initials': 'VW', 'LastName': 'Yeung', 'Affiliation': 'Department of Applied Psychology, Lingnan University, Tuen Mun, Hong Kong.'}, {'ForeName': 'Andrew L', 'Initials': 'AL', 'LastName': 'Geers', 'Affiliation': 'Department of Psychology, University of Toledo, Toledo, OH, USA.'}, {'ForeName': 'Luana', 'Initials': 'L', 'LastName': 'Colloca', 'Affiliation': 'Department of Pain Translational Symptom Science, School of Nursing, University of Maryland, Baltimore, MD, USA.'}]",Annals of behavioral medicine : a publication of the Society of Behavioral Medicine,['10.1093/abm/kaaa035'] 2938,32621741,A randomized phase 4 study of immunogenicity and safety following monovalent oral type 2 Sabin polio vaccine challenge in IPV-vaccinated children in Lithuania.,"BACKGROUND Understanding immunogenicity and safety of monovalent type-2 oral polio vaccine (mOPV2) in inactivated polio vaccine (IPV)-immunized children is of major importance to inform global policy to control circulating vaccine-derived poliovirus (cVDPV) outbreaks. METHODS In this open-label, phase 4 study (NCT02582255) in 100 IPV-vaccinated Lithuanian 1-5-year-olds we measured humoral and intestinal type-2 polio neutralizing antibodies before and 28 days after one or two mOPV2 doses given 28 days apart, and stool viral shedding after each dose. Parents recorded solicited adverse events (AE) for 7 days after each dose and unsolicited AEs for 6 weeks postvaccination. RESULTS After one mOPV2 challenge the type-2 seroprotection rate increased from 98% to 100%. Approximately 28 days after mOPV2 challenge 34 of 68 (50%, 95% CI: 38-62) children were shedding virus; 9 of 37 (24%, 12-41) were shedding 28 days after a second challenge. Before challenge type-2 intestinal immunity was undetectable in IPV-primed children, but 28 of 87 (32%) had intestinal neutralizing titers ≥ 32 after one mOPV2 dose. No vaccine-related serious or severe AEs were reported. CONCLUSIONS High viral excretion following mOPV2 among exclusively IPV-vaccinated children was substantially lower following a subsequent dose, indicating induction of intestinal immunity against type-2 poliovirus.",2020,"Approximately 28 days after mOPV2 challenge 34 of 68 (50%, 95% CI: 38-62) children were shedding virus; 9 of 37 (24%, 12-41) were shedding 28 days after a second challenge.","['IPV-vaccinated children in Lithuania', '100 IPV-vaccinated Lithuanian 1-5-year-olds']","['monovalent oral type 2 Sabin polio vaccine', 'monovalent type-2 oral polio vaccine (mOPV2']","['solicited adverse events (AE', 'humoral and intestinal type-2 polio neutralizing antibodies', 'type-2 seroprotection rate', 'immunogenicity and safety', 'intestinal neutralizing titers ≥']","[{'cui': 'C0718003', 'cui_str': 'Inactivated Poliovirus vaccine'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0023879', 'cui_str': 'Lithuania'}, {'cui': 'C1704407', 'cui_str': '100'}, {'cui': 'C0023880', 'cui_str': 'Lithuanian language'}, {'cui': 'C0008100', 'cui_str': 'Preschool child'}]","[{'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0032371', 'cui_str': 'Acute poliomyelitis'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0032375', 'cui_str': 'Sabin Vaccine'}]","[{'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0021853', 'cui_str': 'Intestinal'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0032371', 'cui_str': 'Acute poliomyelitis'}, {'cui': 'C0282682', 'cui_str': 'Blocking antibody'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0475208', 'cui_str': 'Titer'}]",,0.207036,"Approximately 28 days after mOPV2 challenge 34 of 68 (50%, 95% CI: 38-62) children were shedding virus; 9 of 37 (24%, 12-41) were shedding 28 days after a second challenge.","[{'ForeName': 'Ananda S', 'Initials': 'AS', 'LastName': 'Bandyopadhyay', 'Affiliation': 'Bill & Melinda Gates Foundation, Seattle, USA.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Gast', 'Affiliation': 'Biostatistical Consulting, Sammamish, USA.'}, {'ForeName': 'Elizabeth B', 'Initials': 'EB', 'LastName': 'Brickley', 'Affiliation': 'Department of Infectious Disease Epidemiology, London School of Hygiene & Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Rüttimann', 'Affiliation': 'Fighting Infectious Diseases in Emerging Countries, Miami, Florida, USA.'}, {'ForeName': 'Ralf', 'Initials': 'R', 'LastName': 'Clemens', 'Affiliation': 'Global Research in Infectious Diseases (GRID), Rio de Janeiro, Brazil.'}, {'ForeName': 'M Steven', 'Initials': 'MS', 'LastName': 'Oberste', 'Affiliation': 'Division of Viral Diseases, Centers for Disease Control and Prevention, Atlanta, GA, USA.'}, {'ForeName': 'William C', 'Initials': 'WC', 'LastName': 'Weldon', 'Affiliation': 'Division of Viral Diseases, Centers for Disease Control and Prevention, Atlanta, GA, USA.'}, {'ForeName': 'Margaret E', 'Initials': 'ME', 'LastName': 'Ackerman', 'Affiliation': 'Thayer School of Engineering, Dartmouth College, Hanover, New Hampshire, USA.'}, {'ForeName': 'Ruth I', 'Initials': 'RI', 'LastName': 'Connor', 'Affiliation': 'Department of Pediatrics, Geisel School of Medicine at Dartmouth, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, USA.'}, {'ForeName': 'Wendy F', 'Initials': 'WF', 'LastName': 'Wieland-Alter', 'Affiliation': 'Department of Pediatrics, Geisel School of Medicine at Dartmouth, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Wright', 'Affiliation': 'Department of Pediatrics, Geisel School of Medicine at Dartmouth, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, USA.'}, {'ForeName': 'Vytautas', 'Initials': 'V', 'LastName': 'Usonis', 'Affiliation': ""Clinic of Children's Diseases, Institute of Clinical Medicine, Faculty of Medicine, Vilnius University, Lithuania.""}]",The Journal of infectious diseases,['10.1093/infdis/jiaa390'] 2939,32621874,"Efficacy of vitamin D 3 supplementation for the prevention of pulmonary tuberculosis and mortality in HIV: a randomised, double-blind, placebo-controlled trial.","BACKGROUND Observational data suggest that low vitamin D status is associated with an increased incidence of pulmonary tuberculosis and mortality among people living with HIV. The primary aims of this study were to assess the effect of vitamin D 3 supplementation on the risk of mortality and incidence of pulmonary tuberculosis among adults initiating antiretroviral therapy (ART). METHODS This was a randomised, double-blind, placebo-controlled trial of vitamin D 3 supplementation among adults living with HIV who initiated ART and had serum 25-hydroxyvitamin D concentrations of less than 30 ng/mL at four large HIV care and treatment centres in Dar es Salaam, Tanzania. Patients were excluded if they were younger than 18 years, pregnant at the time of randomisation, or were enrolled in any other clinical trial. Patients were randomly assigned 1:1 to receive either weekly oral 50 000 IU vitamin D 3 supplements (cholecalciferol) for the first month of ART followed by daily 2000 IU vitamin D 3 supplements or a matching weekly and daily placebo regimen. The randomisation list was computer-generated by a non-study statistician with sequence blocks of ten that were stratified by study clinic. Complete allocation concealment was ensured and patients, field team, and investigators were masked to group assignment. The trial follow-up duration was 1 year and the primary efficacy outcomes were death and incident pulmonary tuberculosis. An intention-to-treat analysis was followed for all-cause mortality; participants diagnosed with or receiving treatment for pulmonary tuberculosis at randomisation, or suspected to have tuberculosis at randomisation and who later had that diagnosis confirmed, were excluded from analyses of pulmonary tuberculosis incidence. Safety was assessed in the intention-to-treat population. This study is registered with ClinicalTrials.gov, NCT01798680, and is completed. FINDINGS Between Feb 24, 2014, and Feb 24, 2017, 6250 adults initiating ART had serum 25-hydroxyvitamin D screening, 4000 of whom were enrolled in the trial and followed up for 1 year (follow-up of all participants was completed on March 7, 2018). 2001 patients were randomly assigned to the vitamin D 3 supplementation group, and 1999 to the placebo group. 415 deaths were recorded: 211 in the vitamin D 3 group and 204 in the placebo group. Among all randomly assigned participants, there was no overall effect of vitamin D 3 supplementation on the risk of mortality (hazard ratio [HR] 1·04, 95% CI 0·85-1·25; p=0·73). There was also no difference in the overall incidence of pulmonary tuberculosis between the vitamin D 3 (50 events in 1812 patients analysed) and placebo groups (64 events in 1827 patients; HR 0·78, 0·54-1·13; p=0·19). The vitamin D 3 regimen did not increase the risk of hypercalcaemia (three events in the vitamin D 3 group and two events in the placebo group; relative risk 1·25, 95% CI 0·43-3·66; Fisher's exact p=1·00). 101 hospital admissions were reported in the vitamin D 3 group and 94 in the placebo group (incidence rate ratio 1·06, 95% CI 0·80-1·41; p=0·66). INTERPRETATION Additional research is needed before vitamin D 3 supplementation should be considered for implementation in HIV care and treatment programmes for the prevention of pulmonary tuberculosis or mortality. FUNDING National Institute of Diabetes and Digestive and Kidney Diseases.",2020,"The vitamin D 3 regimen did not increase the risk of hypercalcaemia (three events in the vitamin D 3 group and two events in the placebo group; relative risk 1·25, 95% CI 0·43-3·66; Fisher's exact p=1·00).","['adults initiating antiretroviral therapy (ART', '6250 adults initiating ART had serum 25-hydroxyvitamin D screening, 4000 of whom were enrolled in the trial and followed up for 1 year (follow-up of all participants was completed on March 7, 2018', '2001 patients', 'pulmonary tuberculosis and mortality in HIV', 'Between Feb 24, 2014, and Feb 24, 2017', 'mortality; participants diagnosed with or receiving treatment for pulmonary tuberculosis at randomisation, or suspected to have tuberculosis at randomisation and who later had that diagnosis confirmed, were excluded from analyses of pulmonary tuberculosis incidence', 'adults living with HIV who initiated ART and had serum 25-hydroxyvitamin D concentrations of less than 30 ng/mL at four large HIV care and treatment centres in Dar es Salaam, Tanzania', 'people living with HIV', 'Patients were excluded if they were younger than 18 years, pregnant at the time of randomisation, or were enrolled in any other clinical trial']","['vitamin D 3 supplementation', 'vitamin D 3 supplements (cholecalciferol', 'placebo']","['Safety', '415 deaths', 'risk of hypercalcaemia', '101 hospital admissions', 'risk of mortality and incidence of pulmonary tuberculosis', 'death and incident pulmonary tuberculosis', 'risk of mortality (hazard ratio [HR', 'overall incidence of pulmonary tuberculosis']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0006657', 'cui_str': 'Calcifediol'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C3842327', 'cui_str': '4000'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C1856053', 'cui_str': 'Hydranencephaly with Renal Aplasia-Dysplasia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0041327', 'cui_str': 'Pulmonary tuberculosis'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0750491', 'cui_str': 'Suspected'}, {'cui': 'C0041296', 'cui_str': 'Tuberculosis'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0521093', 'cui_str': 'Confirmed by'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0439275', 'cui_str': 'ug/L'}, {'cui': 'C0549177', 'cui_str': 'Large'}, {'cui': 'C0205099', 'cui_str': 'Central'}, {'cui': 'C0022595', 'cui_str': 'Darier disease'}, {'cui': 'C0039298', 'cui_str': 'Tanzania'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}]","[{'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C4517772', 'cui_str': '415'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0035647', 'cui_str': 'Risk of'}, {'cui': 'C0020437', 'cui_str': 'Hypercalcemia'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0041327', 'cui_str': 'Pulmonary tuberculosis'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",6250.0,0.791652,"The vitamin D 3 regimen did not increase the risk of hypercalcaemia (three events in the vitamin D 3 group and two events in the placebo group; relative risk 1·25, 95% CI 0·43-3·66; Fisher's exact p=1·00).","[{'ForeName': 'Christopher R', 'Initials': 'CR', 'LastName': 'Sudfeld', 'Affiliation': 'Department of Global Health and Population, Harvard TH Chan School of Public Health, Boston, MA, USA; Department of Nutrition, Harvard TH Chan School of Public Health, Boston, MA, USA. Electronic address: csudfeld@hsph.harvard.edu.'}, {'ForeName': 'Ferdinand', 'Initials': 'F', 'LastName': 'Mugusi', 'Affiliation': 'Department of Internal Medicine, Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania.'}, {'ForeName': 'Alfa', 'Initials': 'A', 'LastName': 'Muhihi', 'Affiliation': 'Management and Development for Health, Dar es Salaam, Tanzania.'}, {'ForeName': 'Said', 'Initials': 'S', 'LastName': 'Aboud', 'Affiliation': 'Department of Microbiology and Immunology, Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania.'}, {'ForeName': 'Tumaini J', 'Initials': 'TJ', 'LastName': 'Nagu', 'Affiliation': 'Department of Internal Medicine, Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania.'}, {'ForeName': 'Nzovu', 'Initials': 'N', 'LastName': 'Ulenga', 'Affiliation': 'Management and Development for Health, Dar es Salaam, Tanzania.'}, {'ForeName': 'Biling', 'Initials': 'B', 'LastName': 'Hong', 'Affiliation': 'Department of Epidemiology, Harvard TH Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Molin', 'Initials': 'M', 'LastName': 'Wang', 'Affiliation': ""Department of Epidemiology, Harvard TH Chan School of Public Health, Boston, MA, USA; Department of Biostatistics, Harvard TH Chan School of Public Health, Boston, MA, USA; Channing Division of Network Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.""}, {'ForeName': 'Wafaie W', 'Initials': 'WW', 'LastName': 'Fawzi', 'Affiliation': 'Department of Global Health and Population, Harvard TH Chan School of Public Health, Boston, MA, USA; Department of Nutrition, Harvard TH Chan School of Public Health, Boston, MA, USA; Department of Epidemiology, Harvard TH Chan School of Public Health, Boston, MA, USA.'}]",The lancet. HIV,['10.1016/S2352-3018(20)30108-9'] 2940,32621885,Low-Molecular-Weight Heparin vs Warfarin for Thromboprophylaxis in Children with Coronary Artery Aneurysms After Kawasaki Disease: A Pragmatic Registry Trial.,"BACKGROUND The substantial risk of thrombosis in large coronary artery aneurysms (CAAs) (maximum z-score ≥ 10) after Kawasaki disease (KD) mandates effective thromboprophylaxis. We sought to determine the effectiveness of anticoagulation (low-molecular-weight heparin [LMWH] or warfarin) for thromboprophylaxis in large CAAs. METHODS Data from 383 patients enrolled in the International KD Registry (IKDR) were used. Time-to-event analysis was used to account for differences in treatment duration and follow-up. RESULTS From diagnosis onward (96% received acetylsalicylic acid concomitantly), 114 patients received LMWH (median duration 6.2 months, interquartile range [IQR] 2.5-12.7), 80 warfarin (median duration 2.2 years, IQR 0.9-7.1), and 189 no anticoagulation. Cumulative incidence of coronary artery thrombosis with LMWH was 5.7 ± 3.0%, with warfarin 6.7 ± 3.7%, and with no anticoagulation 20.6 ± 3.0% (P < 0.001) at 2.5 years after the start of thromboprophylaxis (LMWH vs warfarin HR 1.5, 95% confidence interval [CI] 0.4-5.1; P = 0.56). A total of 51/63 patients with coronary artery thrombosis received secondary thromboprophylaxis (ie, thromboprophylaxis after a previous thrombus): 27 LMWH, 24 warfarin. There were no differences in incidence of further coronary artery thrombosis between strategies (HR 2.9, 95% CI 0.6-13.5; P = 0.19). Severe bleeding complications were generally rare (1.6 events per 100 patient-years) and were noted equally for patients on LMWH and warfarin (HR 2.3, 95% CI 0.6-8.9; P = 0.25). CONCLUSIONS LMWH and warfarin appear to have equivalent effectiveness for preventing thrombosis in large CAAs after KD, although event rates for secondary thromboprophylaxis and safety outcomes were low. Based on our findings, all patients with CAA z-score ≥ 10 should receive anticoagulation, but the choice of agent might be informed by secondary risk factors and patient preferences.",2020,"There were no differences in incidence of further coronary artery thrombosis between strategies (HR 2.9, 95% CI 0.6-13.5; P = 0.19).","['51/63 patients with coronary artery thrombosis received secondary thromboprophylaxis (ie, thromboprophylaxis after a previous thrombus): 27 LMWH, 24', 'Children with Coronary Artery Aneurysms', 'Data from 383 patients enrolled in the International KD Registry (IKDR) were used']","['LMWH', 'acetylsalicylic acid', 'warfarin', 'anticoagulation (low-molecular-weight heparin [LMWH] or warfarin', 'LMWH and warfarin', 'Low-Molecular-Weight Heparin vs Warfarin']","['Cumulative incidence of coronary artery thrombosis', 'Severe bleeding complications', 'incidence of further coronary artery thrombosis']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0010072', 'cui_str': 'Coronary artery thrombosis'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0205156', 'cui_str': 'Previous'}, {'cui': 'C0087086', 'cui_str': 'Thrombus'}, {'cui': 'C0019139', 'cui_str': 'Low molecular weight heparin'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0010051', 'cui_str': 'Aneurysm of coronary vessels'}, {'cui': 'C0026691', 'cui_str': 'Acute febrile mucocutaneous lymph node syndrome'}, {'cui': 'C0034975', 'cui_str': 'Registries'}]","[{'cui': 'C0019139', 'cui_str': 'Low molecular weight heparin'}, {'cui': 'C0004057', 'cui_str': 'Aspirin'}, {'cui': 'C0043031', 'cui_str': 'Warfarin'}]","[{'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0010072', 'cui_str': 'Coronary artery thrombosis'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0009566', 'cui_str': 'Complication'}]",383.0,0.190654,"There were no differences in incidence of further coronary artery thrombosis between strategies (HR 2.9, 95% CI 0.6-13.5; P = 0.19).","[{'ForeName': 'Cedric', 'Initials': 'C', 'LastName': 'Manlhiot', 'Affiliation': 'Division of Cardiology, Department of Pediatrics, University of Toronto, Hospital for Sick Children, Toronto, Ontario, Canada.'}, {'ForeName': 'Jane W', 'Initials': 'JW', 'LastName': 'Newburger', 'Affiliation': ""Boston Children's Hospital, Harvard Medical School, Boston, Massachusetts, USA.""}, {'ForeName': 'Tisiana', 'Initials': 'T', 'LastName': 'Low', 'Affiliation': 'Division of Cardiology, Department of Pediatrics, University of Toronto, Hospital for Sick Children, Toronto, Ontario, Canada.'}, {'ForeName': 'Nagib', 'Initials': 'N', 'LastName': 'Dahdah', 'Affiliation': 'Division of Pediatric Cardiology, Centre Hospitalier Universitaire Ste-Justine, University of Montréal, Montréal, Québec, Canada.'}, {'ForeName': 'Andrew S', 'Initials': 'AS', 'LastName': 'Mackie', 'Affiliation': ""Stollery Children's Hospital, Edmonton, Alberta, Canada.""}, {'ForeName': 'Geetha', 'Initials': 'G', 'LastName': 'Raghuveer', 'Affiliation': ""Children's Mercy Hospital, Kansas City, Missouri, USA.""}, {'ForeName': 'Therese M', 'Initials': 'TM', 'LastName': 'Giglia', 'Affiliation': ""Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, USA.""}, {'ForeName': 'Frederic', 'Initials': 'F', 'LastName': 'Dallaire', 'Affiliation': 'Centre de Recherche du Centre Hospitalier Universitaire de Sherbrooke, Sherbrooke, Québec, Canada.'}, {'ForeName': 'Mathew', 'Initials': 'M', 'LastName': 'Mathew', 'Affiliation': 'Division of Cardiology, Department of Pediatrics, University of Toronto, Hospital for Sick Children, Toronto, Ontario, Canada.'}, {'ForeName': 'Kyle', 'Initials': 'K', 'LastName': 'Runeckles', 'Affiliation': 'Division of Cardiology, Department of Pediatrics, University of Toronto, Hospital for Sick Children, Toronto, Ontario, Canada.'}, {'ForeName': 'Elfriede', 'Initials': 'E', 'LastName': 'Pahl', 'Affiliation': ""Ann and Robert H. Lurie Children's Hospital of Chicago, Chicago, Illinois, USA.""}, {'ForeName': 'Ashraf S', 'Initials': 'AS', 'LastName': 'Harahsheh', 'Affiliation': ""Pediatrics-Cardiology, Children's National Health System/George Washington University, Washington, District of Columbia, USA.""}, {'ForeName': 'Kambiz', 'Initials': 'K', 'LastName': 'Norozi', 'Affiliation': 'Department of Paediatrics, Western University, London, Ontario, Canada.'}, {'ForeName': 'Sarah D', 'Initials': 'SD', 'LastName': 'de Ferranti', 'Affiliation': ""Boston Children's Hospital, Harvard Medical School, Boston, Massachusetts, USA.""}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Friedman', 'Affiliation': ""Boston Children's Hospital, Harvard Medical School, Boston, Massachusetts, USA.""}, {'ForeName': 'Anji T', 'Initials': 'AT', 'LastName': 'Yetman', 'Affiliation': ""Children's Hospital and Medical Center of Omaha, Omaha, Nebraska, USA.""}, {'ForeName': 'Shelby', 'Initials': 'S', 'LastName': 'Kutty', 'Affiliation': ""Children's Hospital and Medical Center of Omaha, Omaha, Nebraska, USA.""}, {'ForeName': 'Tapas', 'Initials': 'T', 'LastName': 'Mondal', 'Affiliation': ""McMaster Children's Hospital, Hamilton, Ontario, Canada.""}, {'ForeName': 'Brian W', 'Initials': 'BW', 'LastName': 'McCrindle', 'Affiliation': 'Division of Cardiology, Department of Pediatrics, University of Toronto, Hospital for Sick Children, Toronto, Ontario, Canada. Electronic address: brian.mccrindle@sickkids.ca.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Canadian journal of cardiology,['10.1016/j.cjca.2020.01.016'] 2941,32621898,The Aravind Pseudoexfoliation Study (APEX): 5-year Post-Operative Results. The Effect of IOL Choice and Capsular Tension Rings.,"PURPOSE We compared rates of IOL decentration, Nd:YAG capsulotomy for posterior capsule opacification (PCO), and visual acuity (VA) in eyes with and without pseudoexfoliation (PEX) 5 years after undergoing cataract surgery. DESIGN Prospective comparative interventional study METHODS: . SETTING Multicenter STUDY POPULATION: One eye of both 930 cataract patients with, and 470 cataract patients without, uncomplicated PEX (no small pupils or phacodonesis) all undergoing phacoemulsification by experienced Aravind Eye Care System surgeons. INTERVENTION Eyes were randomized to either one-piece or three-piece intraocular lenses (IOL). PEX eyes were also randomized to either receive or not receive a capsule tension ring (CTR). MAIN OUTCOME MEASURES IOL decentration and posterior capsular opacification (PCO). Secondary outcomes included post-operative best corrected VA. RESULTS Follow-up was 86.2% in the PEX group and 86.7% in the control group at five years. The PEX group was older (p<0.001) and had more men (p=0.01). IOL decentration at 5 years was equally prevalent in PEX and control eyes (1.0% vs. 1.1%, respectively, p=0.8). Nd:YAG posterior capsulotomy rates for PCO were similar in the PEX group when compared to controls (5.3% compared to 3.2%, respectively, p=0.07). Best corrected visual acuity (BCVA) was better at baseline and years 2 and 3 in the control group (p=0.0001, p=0.0005, p=0.02); however, there was no difference in BCVA at years 1, 4 and 5 between the PEX and control groups (p=0.09, p=0.29, p=0.5). CONCLUSIONS In a large-scale, long-term, prospective comparative study of cataract surgery in eyes with uncomplicated PEX, the risks of IOL decentration and PCO were low and comparable to controls. When approaching cataract surgery in eyes with relatively uncomplicated PEX, neither IOL choice (one-piece vs three-piece acrylic IOL) nor the presence/absence of a CTR affects outcomes at 5 years.",2020,"Nd:YAG posterior capsulotomy rates for PCO were similar in the PEX group when compared to controls (5.3% compared to 3.2%, respectively, p=0.07).","['eyes with and without pseudoexfoliation (PEX) 5 years after undergoing cataract surgery', '930 cataract patients with, and 470 cataract patients without, uncomplicated PEX (no small pupils or phacodonesis) all undergoing phacoemulsification by experienced Aravind Eye Care System surgeons', 'PEX eyes']","['one-piece or three-piece intraocular lenses (IOL', 'PEX', 'IOL decentration, Nd:YAG capsulotomy', 'capsule tension ring (CTR', 'cataract surgery']","['PCO', 'post-operative best corrected VA', 'IOL decentration', 'IOL decentration and posterior capsular opacification (PCO', 'Best corrected visual acuity (BCVA', 'BCVA', 'posterior capsule opacification (PCO), and visual acuity (VA']","[{'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0007389', 'cui_str': 'Extraction of cataract'}, {'cui': 'C0086543', 'cui_str': 'Cataract'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0443334', 'cui_str': 'Uncomplicated'}, {'cui': 'C0026205', 'cui_str': 'Persistent miosis'}, {'cui': 'C2939415', 'cui_str': 'Phacodonesis'}, {'cui': 'C0282545', 'cui_str': 'Phacoemulsification'}, {'cui': 'C0885957', 'cui_str': 'Eye care'}, {'cui': 'C0085104', 'cui_str': 'Drug Targeting'}, {'cui': 'C0582175', 'cui_str': 'Surgeon'}]","[{'cui': 'C0023311', 'cui_str': 'Insertion of intraocular lens'}, {'cui': 'C2609312', 'cui_str': 'Intraocular lens decentration'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0233494', 'cui_str': 'Tension'}, {'cui': 'C0521164', 'cui_str': 'Annular shape'}, {'cui': 'C0007389', 'cui_str': 'Extraction of cataract'}]","[{'cui': 'C1306068', 'cui_str': 'Secondary cataract'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C1690532', 'cui_str': 'Best corrected visual acuity'}, {'cui': 'C2609312', 'cui_str': 'Intraocular lens decentration'}, {'cui': 'C0038848', 'cui_str': 'Supplies'}, {'cui': 'C1275680', 'cui_str': 'Corrected visual acuity'}, {'cui': 'C1444680', 'cui_str': 'Posterior capsule opacification'}, {'cui': 'C0042812', 'cui_str': 'Visual acuity'}]",,0.0815359,"Nd:YAG posterior capsulotomy rates for PCO were similar in the PEX group when compared to controls (5.3% compared to 3.2%, respectively, p=0.07).","[{'ForeName': 'Aravind', 'Initials': 'A', 'LastName': 'Haripriya', 'Affiliation': 'Aravind Eye Care System, India.'}, {'ForeName': 'Pradeep Y', 'Initials': 'PY', 'LastName': 'Ramulu', 'Affiliation': 'Wilmer Eye Institute and Bloomberg School of Public Health, The Johns Hopkins University, Baltimore, Maryland.'}, {'ForeName': 'Emily M', 'Initials': 'EM', 'LastName': 'Schehlein', 'Affiliation': 'Kellogg Eye Center, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Madhu', 'Initials': 'M', 'LastName': 'Shekhar', 'Affiliation': 'Aravind Eye Care System, India.'}, {'ForeName': 'Shivkumar', 'Initials': 'S', 'LastName': 'Chandrashekharan', 'Affiliation': 'Aravind Eye Care System, India.'}, {'ForeName': 'Kalpana', 'Initials': 'K', 'LastName': 'Narendran', 'Affiliation': 'Aravind Eye Care System, India.'}, {'ForeName': 'Rengaraj', 'Initials': 'R', 'LastName': 'Venkatesh', 'Affiliation': 'Aravind Eye Care System, India.'}, {'ForeName': 'Mohammed', 'Initials': 'M', 'LastName': 'Sithiq', 'Affiliation': 'Aravind Eye Care System, India.'}, {'ForeName': 'Rengappa', 'Initials': 'R', 'LastName': 'Ramakrishnan', 'Affiliation': 'Aravind Eye Care System, India.'}, {'ForeName': 'Ravilla D', 'Initials': 'RD', 'LastName': 'Ravindran', 'Affiliation': 'Aravind Eye Care System, India.'}, {'ForeName': 'Alan L', 'Initials': 'AL', 'LastName': 'Robin', 'Affiliation': 'Wilmer Eye Institute and Bloomberg School of Public Health, The Johns Hopkins University, Baltimore, Maryland; Kellogg Eye Center, University of Michigan, Ann Arbor, Michigan. Electronic address: arobin@glaucomaexpert.com.'}]",American journal of ophthalmology,['10.1016/j.ajo.2020.06.031'] 2942,32622346,EFFECT OF LOWER BLOOD PRESSURE GOALS ON LEFT VENTRICULAR STRUCTURE AND FUNCTION IN PATIENTS WITH SUBCLINICAL HYPERTENSIVE HEART DISEASE.,"BACKGROUND Subclinical hypertensive heart disease (SHHD) is a precursor to heart failure. Blood pressure (BP) reduction is an important component of secondary disease prevention in patients with SHHD. Treating patients with SHHD utilizing a more intensive BP target (120/80 mm Hg), may lead to improved cardiac function but there has been limited study of this, particularly in African Americans (AAs). METHODS We conducted a single center, randomized controlled trial where subjects with uncontrolled, asymptomatic hypertension, and SHHD not managed by a primary care physician were randomized to standard (<140/90 mm Hg) or intensive (<120/80 mm Hg) BP therapy groups with quarterly follow-up for 12 months. The primary outcome was the differences of BP reduction between these two groups and the secondary outcome was the improvement in echocardiographic measures at 12 months. RESULTS Patients (95% AAs, 65% male, mean age 49.4) were randomized to the standard (n=65) or the intensive (n=58) BP therapy groups. Despite significant reductions in systolic BP (sBP) from baseline (-10.9 vs. -19.1 mm Hg; respectively)(p<0.05), no significant differences were noted between intention-to-treat groups (p=0.33) or the proportion with resolution of SHHD (p=0.31). However, on post-hoc analysis, achievement of a sBP <130 mmHg was associated with significant reduction in indexed left ventricular mass (-6.91 gm/m2.7; p=0.008) which remained significant on mixed effect modeling (p=0.031). CONCLUSIONS In post-hoc analysis, sBP <130 mm Hg in predominantly AA patients with SHHD was associated with improved cardiac function and reverse remodeling and may help to explain preventative effects of lower BP goals.",2020,"Despite significant reductions in systolic BP (sBP) from baseline (-10.9 vs. -19.1 mm Hg; respectively)(p<0.05), no significant differences were noted between intention-to-treat groups (p=0.33) or the proportion with resolution of SHHD (p=0.31).","['subjects with uncontrolled, asymptomatic hypertension, and SHHD not managed by a primary care physician were randomized to standard (<140/90 mm Hg) or intensive (<120/80 mm', 'Treating patients with SHHD utilizing a more intensive BP target (120/80 mm Hg', 'patients with SHHD', 'Hg', 'Patients (95% AAs, 65% male, mean age 49.4', 'Subclinical hypertensive heart disease (SHHD', 'African Americans (AAs']",[],"['cardiac function and reverse remodeling', 'Blood pressure ', 'systolic BP (sBP', 'BP reduction', 'indexed left ventricular mass', 'cardiac function', 'echocardiographic measures']","[{'cui': 'C0205318', 'cui_str': 'Uncontrolled'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic'}, {'cui': 'C0020538', 'cui_str': 'Hypertensive disorder'}, {'cui': 'C0205211', 'cui_str': 'Subclinical'}, {'cui': 'C0152105', 'cui_str': 'Hypertensive heart disease'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0033131', 'cui_str': 'Primary care physician'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0085756', 'cui_str': 'African American'}]",[],"[{'cui': 'C0232164', 'cui_str': 'Cardiac function'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0871470', 'cui_str': 'Systolic blood pressure'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0018827', 'cui_str': 'Cardiac ventricular structure'}, {'cui': 'C0577559', 'cui_str': 'Mass of body structure'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]",,0.120816,"Despite significant reductions in systolic BP (sBP) from baseline (-10.9 vs. -19.1 mm Hg; respectively)(p<0.05), no significant differences were noted between intention-to-treat groups (p=0.33) or the proportion with resolution of SHHD (p=0.31).","[{'ForeName': 'Phillip D', 'Initials': 'PD', 'LastName': 'Levy', 'Affiliation': 'Department of Emergency Medicine, Wayne State University, Detroit, MI.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Burla', 'Affiliation': 'Department of Emergency Medicine, William Beaumont Hospital, Royal Oak, MI.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Twiner', 'Affiliation': 'Department of Emergency Medicine, Wayne State University, Detroit, MI.'}, {'ForeName': 'Alexander L', 'Initials': 'AL', 'LastName': 'Marinica', 'Affiliation': 'Department of Surgery, Sinai-Grace Hospital, Detroit, MI.'}, {'ForeName': 'James J', 'Initials': 'JJ', 'LastName': 'Mahn', 'Affiliation': 'Department of Radiology, University of Michigan, Ann Arbor, MI.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Reed', 'Affiliation': 'Department of Emergency Medicine, Wayne State University, Detroit, MI.'}, {'ForeName': 'Aaron', 'Initials': 'A', 'LastName': 'Brody', 'Affiliation': 'Department of Emergency Medicine, Wayne State University, Detroit, MI.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Ehrman', 'Affiliation': 'Department of Emergency Medicine, Wayne State University, Detroit, MI.'}, {'ForeName': 'Allie', 'Initials': 'A', 'LastName': 'Brodsky', 'Affiliation': 'Department of Emergency Medicine, Wayne State University, Detroit, MI.'}, {'ForeName': 'Yiying', 'Initials': 'Y', 'LastName': 'Zhang', 'Affiliation': 'Integrative Biosciences Center, Wayne State University, Detroit, MI.'}, {'ForeName': 'Samar A', 'Initials': 'SA', 'LastName': 'Nasser', 'Affiliation': 'Department of Clinical Research and Leadership, The George Washington University School of Medicine and Health Sciences, Washington D.C.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Flack', 'Affiliation': 'Department of Internal Medicine, Southern Illinois University, Springfield, Il.'}]",American journal of hypertension,['10.1093/ajh/hpaa108'] 2943,32620131,Gait improvements by assisting hip movements with the robot in children with cerebral palsy: a pilot randomized controlled trial.,"BACKGROUND Recently, rehabilitation robots are expected to improve the gait of cerebral palsy (CP) children. However, only few previous studies have reported the kinematic and kinetic changes by using wearable exoskeleton robots. The aim of this study was to investigate the change in gait parameters in CP children by training with the wearable robot-assisted gait training. METHODS 10 spastic CP children with Gross Motor Function Classification Scale levels I-III completed a sham-controlled crossover randomized trial. Robot-assisted gait training (RAGT) and non-assisted gait training (NAGT) were performed on the treadmill with the Honda Walking Assist (HWA) in two different days. To examine the carry-over effect from treadmill walking to overground walking, participants also performed 5.5 m overground-walks without the HWA before and after treadmill training (pre- and post-trial). During treadmill walking, peak of both hip and knee angles were measured. Also, we calculated the limb symmetry of hip range of motion. In addition, gait speed and ground reaction force were measured in overground trials. RESULTS The maximum hip angle on the limb with fewer hip movements, which was defined as the affected limb, showed a significant interaction between ASSIST (RAGT and NAGT) and TIME (pre- and post-trial) (p < 0.05). Limb symmetry significantly improved after RAGT (p < 0.05), but not in NAGT. Furthermore, the affected limb showed a significant increase in the positive peak of the anterior-posterior ground reaction force during 70-100% of the gait cycle (p < 0.05). However, there was no change in gait speed. CONCLUSION By assisting the both hip movements with the HWA, maximum hip flexion and extension angle of the affected limb improved. Also, limb symmetry and propulsion force of the affected limb improved. Our results suggest that assisting both hip movements with the HWA might be an effective method for improving gait in CP children. TRIAL REGISTRATION UMIN-CTR, UMIN000030667. Registered 3 January 2018, https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033737.",2020,"Limb symmetry significantly improved after RAGT (p < 0.05), but not in NAGT.","['10 spastic CP children with Gross Motor Function Classification Scale levels I-III completed a sham-controlled crossover randomized trial', 'CP children by training with the wearable robot-assisted gait training', 'children with cerebral palsy', 'cerebral palsy (CP) children']","['Robot-assisted gait training (RAGT) and non-assisted gait training (NAGT', 'treadmill walking to overground walking, participants also performed 5.5\u2009m overground-walks without the HWA before and after treadmill training']","['Gait improvements', 'positive peak of the anterior-posterior ground reaction force', 'maximum hip angle on the limb with fewer hip movements', 'gait speed', 'limb symmetry of hip range of motion', 'gait speed and ground reaction force', 'Limb symmetry', 'gait parameters', 'limb symmetry and propulsion force']","[{'cui': 'C0338596', 'cui_str': 'Spastic cerebral palsy'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0677549', 'cui_str': 'Gross motor functions'}, {'cui': 'C0008902', 'cui_str': 'Classification'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0441925', 'cui_str': 'Level I'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0150097', 'cui_str': 'Crossover Trials'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0007789', 'cui_str': 'Cerebral palsy'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0085673', 'cui_str': 'Gait training procedure'}]","[{'cui': 'C0336537', 'cui_str': 'Robot'}, {'cui': 'C0018896', 'cui_str': 'Helping Behavior'}, {'cui': 'C0085673', 'cui_str': 'Gait training procedure'}, {'cui': 'C0184069', 'cui_str': 'Treadmill'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C3844008', 'cui_str': '5.5'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0016928', 'cui_str': 'Gait'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0205094', 'cui_str': 'Anterior'}, {'cui': 'C0205095', 'cui_str': 'Dorsal'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0443221', 'cui_str': 'Forced'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0019552', 'cui_str': 'Bone structure of hip'}, {'cui': 'C0205143', 'cui_str': 'Angular'}, {'cui': 'C0015385', 'cui_str': 'Limb structure'}, {'cui': 'C0205388', 'cui_str': 'Few'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C2009910', 'cui_str': 'Gait speed'}, {'cui': 'C0332516', 'cui_str': 'Symmetrical'}, {'cui': 'C0576002', 'cui_str': 'Hip joint - range of movement'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",,0.0698618,"Limb symmetry significantly improved after RAGT (p < 0.05), but not in NAGT.","[{'ForeName': 'Shihomi', 'Initials': 'S', 'LastName': 'Kawasaki', 'Affiliation': 'Department of Physical Therapy, Human Health Sciences, Kyoto University Graduate School of Medicine, Kyoto, Japan. kawasaki.shihomi.55n@kyoto-u.jp.'}, {'ForeName': 'Koji', 'Initials': 'K', 'LastName': 'Ohata', 'Affiliation': 'Department of Physical Therapy, Human Health Sciences, Kyoto University Graduate School of Medicine, Kyoto, Japan.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Yoshida', 'Affiliation': 'Department of Pediatrics, Kyoto University Graduate School of Medicine, Kyoto, Japan.'}, {'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Yokoyama', 'Affiliation': 'Department of Pediatrics, Kyoto University Graduate School of Medicine, Kyoto, Japan.'}, {'ForeName': 'Shigehito', 'Initials': 'S', 'LastName': 'Yamada', 'Affiliation': 'Department of Physical Therapy, Human Health Sciences, Kyoto University Graduate School of Medicine, Kyoto, Japan.'}]",Journal of neuroengineering and rehabilitation,['10.1186/s12984-020-00712-3'] 2944,32620144,The curative effects of shortwave diathermy on treating Novel coronavirus (COVID-19) pneumonia: A structured summary of a study protocol for a randomised controlled trial.,"OBJECTIVES To evaluate the therapeutic effects of ultra-short-wave diathermy (SWD) on COVID-19 pneumonia. The hypothesis is that SWD may minimise pneumonic inflammation and shorten the duration of the time to positive-to-negative conversion of COVID-19 nucleic acid test. TRIAL DESIGN This is a single centre, 2-arm (1:1 ratio), evaluator blinded, parallel group design superiority randomised, controlled clinical trial. PARTICIPANTS The inclusion criteria were: (1) Age 18-65 years, (2) COVID-19 nucleic acid test is positive, (3) Lung CT showed multiple patchy ground glass shadows or other typical manifestations of both lungs. The exclusion criteria were: (1) Patients who need ICU management, (2) Positive tests for other pathogens such as Tuberculosis, Mycoplasma, (3) Patients with respiratory failure or requiring mechanical ventilation, (4) Patients with metal implants or pacemakers, (5) Those with shock (6) Those that have bleeding tendency or active bleeding in the lungs, (7) Patients with multiple organ failure who need ICU monitoring and treatment, (8) Cancer patients and those with severe underlying diseases, (9) Pregnant or lactating women, (10) Patients with severe cognitive impairment who cannot follow the instructions to complete the treatment, (11) Those without signed informed consent and (12) Those with other contraindications to short wave. This study will be conducted in Tongji Hospital, Caidian, Wuhan, People's Republic of China. INTERVENTION AND COMPARATOR The experimental group will be given the nationally recommended standard medical treatment + ultra-short-wave diathermy treatment. Ultra-short-wave therapy treatment will be performed through application of ultra-short-wave therapy machine electrodes on the anterior and posterior parts of the trunk for 10 minutes, twice a day for 12 consecutive days. The comparator will be the control, not receiving ultra-short-wave therapy, and will be given only the nationally recommended standard medical treatment. MAIN OUTCOMES The primary outcome measures will be time to positive-to-negative conversion of COVID-19 nucleic acid test by pharyngeal swab, in days assessed at 7 th , 14 th ,21 st and 28 th days. The secondary outcome measures include nucleic acid test rate and recovery from symptoms, Vital signs assessment, Computed Tomography, Complete blood count, serum analysis and SIRS scale scores. Blinded evaluation will be at baseline (the day of starting ultra-short-wave diathermy) and after 28 days following the interventions. RANDOMISATION A Randomization plan will be generated online on www.randomization.com using permuted blocks method, by a statistician who will not be part of the study. Small blocks of various sizes will be used. Patients will be randomized (1:1) between the experimental and control groups BLINDING (MASKING): This will be an evaluator blinded study. Due to the nature of the intervention, blinding of patients and healthcare workers is not possible. NUMBERS TO BE RANDOMISED (SAMPLE SIZE) A total of 410 patients will be randomised in 1:1 ratio to two groups: experimental group (n=205) and control group (n=205). TRIAL STATUS Protocol version 1 was approved on 02/12/2020. Recruitment for this trial began on 02/18/2020 and will be ongoing till the required sample size is reached. The analysis deadline is August 2020. TRIAL REGISTRATION This randomised controlled trial has been prospectively registered with the Chinese Clinical Trials ( ChiCTR2000029972 ) on 17 February 2020. FULL PROTOCOL The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol."" The study protocol has been reported in accordance with the Standard Protocol Items: Recommendations for Clinical Interventional Trials (SPIRIT) guidelines (Additional file 2).",2020,"The comparator will be the control, not receiving ultra-short-wave therapy, and will be given only the nationally recommended standard medical treatment. ","['The exclusion criteria were: (1) Patients who need ICU management, (2) Positive tests for other pathogens such as Tuberculosis, Mycoplasma, (3) Patients with respiratory failure or requiring mechanical ventilation, (4) Patients with metal implants or pacemakers, (5', ""Tongji Hospital, Caidian, Wuhan, People's Republic of China"", '410 patients', 'The inclusion criteria were: (1) Age 18-65 years, (2) COVID-19 nucleic acid test is positive, (3) Lung CT showed multiple patchy ground glass shadows or other typical manifestations of both lungs', '17 February 2020', 'Patients with multiple organ failure who need ICU monitoring and treatment, (8) Cancer patients and those with severe underlying diseases, (9) Pregnant or lactating women, (10) Patients with severe cognitive impairment who cannot follow the instructions to complete the treatment, (11']","['standard medical treatment + ultra-short-wave diathermy treatment', 'shortwave diathermy', 'ultra-short-wave diathermy (SWD']","['COVID-19 pneumonia', 'time to positive-to-negative conversion of COVID-19 nucleic acid test by pharyngeal swab', 'bleeding tendency or active bleeding', 'nucleic acid test rate and recovery from symptoms, Vital signs assessment, Computed Tomography, Complete blood count, serum analysis and SIRS scale scores', 'treating Novel coronavirus (COVID-19) pneumonia']","[{'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027552', 'cui_str': 'Needed'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0001554', 'cui_str': 'Administration'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0450254', 'cui_str': 'Pathogenic organism'}, {'cui': 'C0041296', 'cui_str': 'Tuberculosis'}, {'cui': 'C0026934', 'cui_str': 'Genus Mycoplasma'}, {'cui': 'C1145670', 'cui_str': 'Respiratory failure'}, {'cui': 'C0199470', 'cui_str': 'Mechanical ventilation'}, {'cui': 'C0025552', 'cui_str': 'Metal'}, {'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C0030163', 'cui_str': 'Cardiac pacemaker'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0008115', 'cui_str': 'China'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0028606', 'cui_str': 'Nucleic acid'}, {'cui': 'C0412611', 'cui_str': 'CT of lungs'}, {'cui': 'C0439064', 'cui_str': 'Numerous'}, {'cui': 'C0205413', 'cui_str': 'Patchy'}, {'cui': 'C0015421', 'cui_str': 'Eyeglasses'}, {'cui': 'C0085195', 'cui_str': 'Shadowing (Histology)'}, {'cui': 'C0205319', 'cui_str': 'Manifest'}, {'cui': 'C0225754', 'cui_str': 'Both lungs'}, {'cui': 'C0026766', 'cui_str': 'Multiple organ failure'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0549206', 'cui_str': 'Pregnant'}, {'cui': 'C0022924', 'cui_str': 'Lactates'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C3554639', 'cui_str': 'Severe cognitive impairment'}, {'cui': 'C0231290', 'cui_str': 'Status post'}, {'cui': 'C0033344', 'cui_str': 'Programmed Instruction'}, {'cui': 'C0205197', 'cui_str': 'Complete'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0204027', 'cui_str': 'Short wave diathermy'}, {'cui': 'C0012002', 'cui_str': 'Diathermy'}]","[{'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0205160', 'cui_str': 'Negative'}, {'cui': 'C0439836', 'cui_str': 'Conversions'}, {'cui': 'C0028606', 'cui_str': 'Nucleic acid'}, {'cui': 'C0003647', 'cui_str': 'Aptitude Tests'}, {'cui': 'C0439056', 'cui_str': 'Throat swab'}, {'cui': 'C0005779', 'cui_str': 'Blood coagulation disorder'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0150404', 'cui_str': 'Taking patient vital signs'}, {'cui': 'C0040405', 'cui_str': 'Computerized axial tomography'}, {'cui': 'C0009555', 'cui_str': 'Complete blood count'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0242966', 'cui_str': 'Systemic inflammatory response syndrome'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}]",410.0,0.251351,"The comparator will be the control, not receiving ultra-short-wave therapy, and will be given only the nationally recommended standard medical treatment. ","[{'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Nasb', 'Affiliation': ""Department of Rehabilitation Medicine, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430030, People's Republic of China.""}, {'ForeName': 'Zulfiqar Ali', 'Initials': 'ZA', 'LastName': 'Sayed Shah', 'Affiliation': ""Department of Rehabilitation Medicine, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430030, People's Republic of China.""}, {'ForeName': 'Liangjiang', 'Initials': 'L', 'LastName': 'Huang', 'Affiliation': ""Department of Rehabilitation Medicine, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430030, People's Republic of China.""}, {'ForeName': 'Qian', 'Initials': 'Q', 'LastName': 'Li', 'Affiliation': ""Department of Rehabilitation Medicine, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430030, People's Republic of China.""}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Chen', 'Affiliation': ""Department of Rehabilitation Medicine, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430030, People's Republic of China. chenhong1129@hust.edu.cn.""}]",Trials,['10.1186/s13063-020-04534-5'] 2945,32620149,"Design and methods of a national, multicenter, randomized and controlled trial to assess the efficacy of a physical activity program to improve health-related quality of life and reduce fatigue in women with metastatic breast cancer: ABLE02 trial.","BACKGROUND Patients with a metastatic breast cancer suffer from a deteriorated health-related quality of life and numerous symptoms such as pain, severe fatigue and a decrease of their physical fitness. As the feasibility of a physical activity program has been demonstrated in this population, ABLE02 aims to assess the efficacy of a 6 month-physical activity program using connected devices to improve health-related quality of life and to reduce fatigue in women with metastatic breast cancer. METHODS ABLE02 is a prospective, national, multicenter, randomized, controlled and open-label study. A total of 244 patients with a metastatic breast cancer, with at least one positive hormone receptor and a first-line chemotherapy planned, will be randomly assigned (1:1 ratio) to: (i) the intervention arm to receive physical activity recommendations, an activity tracker to wear 24 h a day during the whole intervention (6 months) with at least three weekly walking sessions and quizzes each week on physical activity and nutrition (ii) the control arm to receive physical activity recommendations only. Health-related quality of life will be assessed every 6 weeks and main assessments will be conducted at baseline, M3, M6, M12 and M18 to evaluate the clinical, physical, biological and psychological parameters and survival of participants. All questionnaires will be completed on a dedicated application. DISCUSSION An activity program based on a smartphone application linked to an activity tracker may help to improve quality of life and reduce fatigue of patients with a metastatic breast cancer. The growth of e-health offers the opportunity to get real-time data as well as improving patient empowerment in order to change long-term behaviors. TRIAL REGISTRATION NCT number: NCT04354233 .",2020,"Health-related quality of life will be assessed every 6 weeks and main assessments will be conducted at baseline, M3, M6, M12 and M18 to evaluate the clinical, physical, biological and psychological parameters and survival of participants.","['women with metastatic breast cancer', '244 patients with a metastatic breast cancer, with at least one positive hormone receptor and a first-line chemotherapy planned', 'patients with a metastatic breast cancer', 'Patients with a metastatic breast cancer']","['physical activity program', 'physical activity recommendations, an activity tracker to wear 24\u2009h a day during the whole intervention (6\u2009months) with at least three weekly walking sessions and quizzes each week on physical activity and nutrition (ii) the control arm to receive physical activity recommendations only']","['quality of life', 'health-related quality of life and reduce fatigue', 'Health-related quality of life']","[{'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0278488', 'cui_str': 'Breast cancer stage IV'}, {'cui': 'C4517660', 'cui_str': '244'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0270724', 'cui_str': 'Infantile neuroaxonal dystrophy'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C4264352', 'cui_str': 'Activity Trackers'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0332174', 'cui_str': 'Weekly'}, {'cui': 'C0028707', 'cui_str': 'Nutrition Sciences'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]","[{'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0392756', 'cui_str': 'Reduced'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}]",244.0,0.0680548,"Health-related quality of life will be assessed every 6 weeks and main assessments will be conducted at baseline, M3, M6, M12 and M18 to evaluate the clinical, physical, biological and psychological parameters and survival of participants.","[{'ForeName': 'Lidia', 'Initials': 'L', 'LastName': 'Delrieu', 'Affiliation': 'Department of Cancer and Environment, Léon Bérard Cancer Center, 28 rue Laennec, 69008, Lyon, France.'}, {'ForeName': 'Amélie', 'Initials': 'A', 'LastName': 'Anota', 'Affiliation': 'Methodology and Quality of Life in Oncology unit (INSERM UMR 1098), University Hospital of Besançon, Besançon, France.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Trédan', 'Affiliation': 'Department of Medical Oncology, Léon Bérard Cancer Center, Lyon, France.'}, {'ForeName': 'Damien', 'Initials': 'D', 'LastName': 'Freyssenet', 'Affiliation': 'Inter-University Laboratory of Human Movement Biology EA7424, Univ Lyon, University Jean Monnet Saint-Etienne, Saint-Etienne, France.'}, {'ForeName': 'Aurélia', 'Initials': 'A', 'LastName': 'Maire', 'Affiliation': 'Department of Cancer and Environment, Léon Bérard Cancer Center, 28 rue Laennec, 69008, Lyon, France.'}, {'ForeName': 'Brice', 'Initials': 'B', 'LastName': 'Canada', 'Affiliation': 'Laboratory on Vulnerabilities and Innovations in Sport, University Claude Bernard Lyon 1, University of Lyon, Villeurbanne, France.'}, {'ForeName': 'Baptiste', 'Initials': 'B', 'LastName': 'Fournier', 'Affiliation': 'Department of Cancer and Environment, Léon Bérard Cancer Center, 28 rue Laennec, 69008, Lyon, France.'}, {'ForeName': 'Olivia', 'Initials': 'O', 'LastName': 'Febvey-Combes', 'Affiliation': 'Department of Clinical Research and Innovation, Léon Bérard Cancer Center, Lyon, France.'}, {'ForeName': 'Frank', 'Initials': 'F', 'LastName': 'Pilleul', 'Affiliation': 'Department of Interventional Radiology, Léon Bérard Cancer Center, Lyon, France.'}, {'ForeName': 'Amine', 'Initials': 'A', 'LastName': 'Bouhamama', 'Affiliation': 'Department of Interventional Radiology, Léon Bérard Cancer Center, Lyon, France.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Caux', 'Affiliation': 'Univ Lyon, Université Claude Bernard Lyon 1, INSERM 1052, CNRS 5286, Cancer Research Center of Lyon (CRCL), Léon Bérard Cancer Center, Lyon, France.'}, {'ForeName': 'Florence', 'Initials': 'F', 'LastName': 'Joly', 'Affiliation': 'Medical Oncology Department, Centre François Baclesse, Caen, France.'}, {'ForeName': 'Béatrice', 'Initials': 'B', 'LastName': 'Fervers', 'Affiliation': 'Department of Cancer and Environment, Léon Bérard Cancer Center, 28 rue Laennec, 69008, Lyon, France.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Pialoux', 'Affiliation': 'Inter-University Laboratory of Human Movement Biology EA7424, University Claude Bernard Lyon 1, University of Lyon, Villeurbanne, France.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Pérol', 'Affiliation': 'Department of Clinical Research and Innovation, Léon Bérard Cancer Center, Lyon, France.'}, {'ForeName': 'Olivia', 'Initials': 'O', 'LastName': 'Pérol', 'Affiliation': 'Department of Cancer and Environment, Léon Bérard Cancer Center, 28 rue Laennec, 69008, Lyon, France. olivia.perol@lyon.unicancer.fr.'}]",BMC cancer,['10.1186/s12885-020-07093-9'] 2946,32620155,"A double blind, placebo-controlled randomized comparative study on the efficacy of phytosterol-enriched and conventional saw palmetto oil in mitigating benign prostate hyperplasia and androgen deficiency.","BACKGROUND The present clinical trial was conducted to evaluate the efficacy and tolerability of a standardized saw palmetto oil containing 3% β-sitosterol in the treatment of benign prostate hyperplasia (BPH) and androgen deficiency. METHODS Subjects aged 40-65 years with symptomatic BPH were randomized to 12-week double-blind treatment with 500 mg doses of β-sitosterol enriched saw palmetto oil, conventional saw palmetto oil and placebo orally in the form of capsules (n = 33 in each group). BPH severity was determined using the International Prostate Symptom Score (IPSS), uroflowmetry, serum measurement of prostate specific antigen (PSA), testosterone and 5α-reductase. During the trial, the androgen deficiency was evaluated using Aging Male Symptoms (AMS) scale, the Androgen Deficiency in the Aging Male (ADAM) questionnaire, serum levels of free testosterone. RESULTS Subjects treated with β-sitosterol enriched saw palmetto oil showed significant decrease in IPSS, AMS and ADAM scores along with reduced postvoiding residual volume (p < 0.001), PSA (p < 0.01) and 5α-reductase from baseline to end of 12-week treatment as compared to placebo. There was also a significant increment in the maximum and average urine flow rate (p < 0.001), and serum free testosterone level of subjects treated with enriched saw palmetto oil as compared to placebo. CONCLUSION This study demonstrates the efficacy of β-sitosterol enriched saw palmetto oil superior to conventional oil thus extending the scope of effective BPH and androgen deficiency treatment with improved quality of life through the intake of functional ingredients. TRIAL REGISTRATION CTRI/2018/12/016724 dated 19/12/2018 prospectively registered. URL: http://ctri.nic.in/Clinicaltrials/advsearch.php.",2020,"There was also a significant increment in the maximum and average urine flow rate (p < 0.001), and serum free testosterone level of subjects treated with enriched saw palmetto oil as compared to placebo. ","['benign prostate hyperplasia (BPH) and androgen deficiency', 'Subjects aged 40-65\u2009years with symptomatic BPH']","['β-sitosterol enriched saw palmetto oil, conventional saw palmetto oil and placebo', 'phytosterol-enriched and conventional saw palmetto oil', 'standardized saw palmetto oil containing 3% β-sitosterol', 'placebo']","['IPSS, AMS and ADAM scores', 'maximum and average urine flow rate', 'serum free testosterone level', 'Aging Male Symptoms (AMS) scale, the Androgen Deficiency in the Aging Male (ADAM) questionnaire, serum levels of free testosterone', 'efficacy and tolerability', 'PSA', 'BPH severity', 'International Prostate Symptom Score (IPSS), uroflowmetry, serum measurement of prostate specific antigen (PSA), testosterone and 5α-reductase']","[{'cui': 'C1704272', 'cui_str': 'Benign prostatic hyperplasia'}, {'cui': 'C0342527', 'cui_str': 'Deficiency of testosterone biosynthesis'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic'}]","[{'cui': 'C0037215', 'cui_str': 'Sitosterols'}, {'cui': 'C0697222', 'cui_str': 'Sabal serrulata'}, {'cui': 'C0028908', 'cui_str': 'Oil'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0031866', 'cui_str': 'Phytosterols'}, {'cui': 'C0332256', 'cui_str': 'Containing'}]","[{'cui': 'C1998280', 'cui_str': 'International prostate symptom score'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0086582', 'cui_str': 'Male'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0342527', 'cui_str': 'Deficiency of testosterone biosynthesis'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0232851', 'cui_str': 'Flow of urine'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0202228', 'cui_str': 'Testosterone measurement, unbound'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0138741', 'cui_str': 'Prostate specific antigen'}, {'cui': 'C1704272', 'cui_str': 'Benign prostatic hyperplasia'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0200008', 'cui_str': 'Uroflowmetry'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0039601', 'cui_str': 'Testosterone'}, {'cui': 'C0030016', 'cui_str': 'Oxidoreductase'}]",,0.41981,"There was also a significant increment in the maximum and average urine flow rate (p < 0.001), and serum free testosterone level of subjects treated with enriched saw palmetto oil as compared to placebo. ","[{'ForeName': 'H V', 'Initials': 'HV', 'LastName': 'Sudeep', 'Affiliation': 'R&D Center for Excellence, Vidya Herbs Pvt. Ltd, #14A, Jigani I phase, Bangalore, Karnataka, 560 105, India. sudeepkashyap.82@gmail.com.'}, {'ForeName': 'Jestin V', 'Initials': 'JV', 'LastName': 'Thomas', 'Affiliation': 'Leads Clinical Research and Bio services Private Ltd., Bangalore, India.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Shyamprasad', 'Affiliation': 'R&D Center for Excellence, Vidya Herbs Pvt. Ltd, #14A, Jigani I phase, Bangalore, Karnataka, 560 105, India.'}]",BMC urology,['10.1186/s12894-020-00648-9'] 2947,32620163,ICON: a randomized phase IIb study evaluating immunogenic chemotherapy combined with ipilimumab and nivolumab in patients with metastatic hormone receptor positive breast cancer.,"BACKGROUND Immunotherapy with checkpoint inhibitors (CPI) targeting PD-1 or CTLA-4 has emerged as an important treatment modality for several cancer forms. In hormone receptor positive breast cancer (HR + BC), this therapeutic approach is largely unexplored. We have started a clinical trial, ICON (CA209-9FN), evaluating CPI combined with selected chemotherapy in patients with metastatic HR + BC. The tumor lymphocyte infiltration is predictive for the effect of chemotherapy in BC. In ICON, we use anthracycline, which are considered as ""immunogenic"" chemotherapy, and low-dose cyclophosphamide, which has been reported to counter immunosuppressive cells. METHODS ICON is a randomized exploratory phase IIb study evaluating the safety and efficacy of combining nivolumab (nivo; anti-PD-1) and ipilimumab (ipi; anti-CTLA-4) with chemotherapy in subjects with metastatic HR + BC. Primary objectives are aassessment of toxicity and progression-free survival. The trial will enrol 75 evaluable subjects, randomized 2:3 into two arms (A:B). Patients in Arm A receive only chemotherapy, i.e. pegylated liposomal doxorubicin (PLD 20 mg/m 2 intravenously every 2nd week) + cyclophosphamide (cyclo; 50 mg per day, first 2 weeks in each 4 week cycle). Patients in Arm B receive PLD + cyclo + ipilimumab (1 mg intravenously every 6th week) + nivolumab (240 mg intravenously every 2nd week). Patients in arm A will be offered ipi + nivo after disease progression. DISCUSSION ICON is among the first clinical trials combining chemotherapy with PD-1 and CTLA-4 blockade, and the first in BC. There is a strong preclinical rationale for exploring if anthracyclines, which are considered to induce immunogenic cell death, synergize with CPI, and for combining PD-1 and CTLA-4 blockade, as these checkpoints are important in different phases of the immune response. If the ICON trial suggests acceptable safety and provide a signal of clinical efficacy, further studies are warranted. The cross-over patients from Arm A receiving ipilimumab/nivolumab without concomitant chemotherapy represent the first BC cohort receiving this therapy. The ICON trial includes a series of translational sub-projects addressing clinically important knowledge gaps. These studies may uncover biomarkers or mechanisms of efficacy and resistance, thereby informing the development of novel combinatory regimes and of personalised biomarker-based therapy. Trial registration NCT03409198, Jan 24th 2018; https://clinicaltrials.gov/ct2/show/record/NCT03409198.",2020,"Patients in Arm A receive only chemotherapy, i.e. pegylated liposomal doxorubicin","['patients with metastatic hormone', '75 evaluable subjects', 'subjects with metastatic HR\u2009+\u2009BC', 'patients with metastatic HR\u2009+\u2009BC', 'receptor positive breast cancer']","['ICON', 'combining nivolumab (nivo; anti-PD-1) and ipilimumab (ipi; anti-CTLA-4) with chemotherapy', 'cyclophosphamide', 'CPI combined with selected chemotherapy', 'immunogenic chemotherapy combined with ipilimumab and nivolumab', 'ipilimumab/nivolumab without concomitant chemotherapy', 'chemotherapy, i.e. pegylated liposomal doxorubicin', 'PLD\u2009+\u2009cyclo\u2009+\u2009ipilimumab']","['safety and efficacy', 'aassessment of toxicity and progression-free survival']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0019932', 'cui_str': 'Hormone'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0006142', 'cui_str': 'Malignant tumor of breast'}]","[{'cui': 'C0243020', 'cui_str': 'Immunoconjugate'}, {'cui': 'C0205195', 'cui_str': 'Combined'}, {'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C1367202', 'cui_str': 'ipilimumab'}, {'cui': 'C0111208', 'cui_str': 'Cytotoxic T-Lymphocyte Antigen 4'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C1155874', 'cui_str': 'Cell Cycle Checkpoints'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0717726', 'cui_str': 'doxorubicin liposome'}, {'cui': 'C0044369', 'cui_str': '1-dodecylpyridoxal'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",,0.0648991,"Patients in Arm A receive only chemotherapy, i.e. pegylated liposomal doxorubicin","[{'ForeName': 'J A', 'Initials': 'JA', 'LastName': 'Kyte', 'Affiliation': 'Department of Clinical Cancer Research, Oslo University Hospital, Oslo, Norway. jonky@ous-hf.no.'}, {'ForeName': 'N K', 'Initials': 'NK', 'LastName': 'Andresen', 'Affiliation': 'Department of Clinical Cancer Research, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'H G', 'Initials': 'HG', 'LastName': 'Russnes', 'Affiliation': 'Department of Cancer Genetics, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'S Ø', 'Initials': 'SØ', 'LastName': 'Fretland', 'Affiliation': 'Department of Clinical Cancer Research, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'R S', 'Initials': 'RS', 'LastName': 'Falk', 'Affiliation': 'Oslo Centre for Biostatistics and Epidemiology, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'O C', 'Initials': 'OC', 'LastName': 'Lingjærde', 'Affiliation': 'Department of Cancer Genetics, Oslo University Hospital, Oslo, Norway.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Naume', 'Affiliation': 'Department of Oncology, Oslo University Hospital, Oslo, Norway.'}]",Journal of translational medicine,['10.1186/s12967-020-02421-w'] 2948,32620174,Comparison of two methods to clear the airways of critically ill children and adults with COVID-19 infection: a structured summary of a study protocol for a pilot randomized controlled trial.,"OBJECTIVES As there is no treatment for COVID-19 with a proven mortality benefit at this moment in the pandemic, supportive management including mechanical ventilation is the core management in an intensive care unit (ICU). It is a challenge to provide consistent care in this situation, highly demanding and leading to potential staff shortages in ICU. We need to reduce unnecessary exposure of healthcare workers to the virus. This study aims to examine the impact of care using a non-invasive oscillating device (NIOD) for chest physiotherapy in the care of mechanically ventilated patients with COVID-19. In particular, we aim to explore if a NIOD performed by non-specialized personnel is not inferior to the standard chest physiotherapy (CPT) undertaken by physiotherapists caring for patients with COVID-19. TRIAL DESIGN A pilot multicenter prospective crossover noninferiority randomized controlled trial. PARTICIPANTS All mechanically ventilated patients with COVID-19 admitted to one of the two ICUs, and CPT ordered by the responsible physician. The participants will be recruited from two intensive care units in Canadian Academic Hospitals (one pediatric and one adult ICU). INTERVENTION AND COMPARATOR We will implement NIOD and CPT alternatingly for 3 h apart over 3 h. We will apply a pragmatic design, so that other procedures including hypertonic saline nebulization, intermittent positive pressure ventilation, suctioning (e.g., oral or nasal), or changing the ventilator settings or modality (i.e., increasing positive end-expiratory pressure or changing the nasal mask to total face continuous positive airway pressure) can be provided at the direction of bedside intensivists in charge. MAIN OUTCOMES The primary outcome measurement is the oxygenation level before and after the procedure (SpO 2 /FiO 2 ratio). For cases with invasive ventilation (i.e., the use of an endotracheal tube to deliver positive pressure) and non-invasive ventilation, we will also document expiratory tidal volume, vital signs, and any related complications such as vomiting, hypoxemia, or unexpected extubation. We will collect the data before, 10 min after, and 30 min after the procedure. RANDOMIZATION The order of the procedures (i.e., NIOD or CPT) will be randomly allocated using manual generated random numbers for each case. Randomization will be carried out by the independent research assistant in the study coordinating center by using opaque sealed envelopes, assigning an equal number of cases to each intervention arm. Stratification will be applied for age (> 18 years or ≤ 18 years of age) and the study sites. BLINDING (MASKING) No blinding will be performed. NUMBERS TO BE RANDOMIZED (SAMPLE SIZE) We estimate the necessary sample size as 25 for each arm (total 50 cases), with a power of 0.90 and an alpha of 0.05, with a non-inferiority design. TRIAL STATUS The protocol version number 1 was approved on 27 March 2020. Currently, recruitment has not yet started, with the start scheduled by the mid-June 2020 and the end anticipated by December 2020. TRIAL REGISTRATION ClinicalTrials.gov NCT04361435 . Registered on 28 April 2020 FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (Additional File 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this letter serves as a summary of the key elements of the full protocol.",2020,"In particular, we aim to explore if a NIOD performed by non-specialized personnel is not inferior to the standard chest physiotherapy (CPT) undertaken by physiotherapists caring for patients with COVID-19. ","['All mechanically ventilated patients with COVID-19 admitted to one of the two ICUs, and CPT ordered by the responsible physician', 'mechanically ventilated patients with COVID-19', 'participants will be recruited from two intensive care units in Canadian Academic Hospitals (one pediatric and one adult ICU', 'age (>\u200918\u2009years or\u2009≤\u200918\u2009years of age) and the study sites', 'Registered on 28 April 2020', 'critically ill children and adults with COVID-19 infection', 'physiotherapists caring for patients with COVID-19']","['care using a non-invasive oscillating device (NIOD', 'standard chest physiotherapy (CPT', 'hypertonic saline nebulization, intermittent positive pressure ventilation, suctioning (e.g., oral or nasal), or changing the ventilator settings or modality (i.e., increasing positive end-expiratory pressure or changing the nasal mask to total face continuous positive airway pressure']",['oxygenation level'],"[{'cui': 'C1299448', 'cui_str': 'Patient ventilated'}, {'cui': 'TS-COV19', 'cui_str': 'COVID-19'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission'}, {'cui': 'C0199467', 'cui_str': 'Physiotherapy of chest'}, {'cui': 'C4284072', 'cui_str': 'Order document'}, {'cui': 'C1273518', 'cui_str': 'Responsible to'}, {'cui': 'C0031831', 'cui_str': 'Physician'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit'}, {'cui': 'C0238884', 'cui_str': 'Canadian'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}, {'cui': 'C0030755', 'cui_str': 'Pediatric specialty'}, {'cui': 'C0587445', 'cui_str': 'Adult intensive care unit'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0600375', 'cui_str': 'Registers'}, {'cui': 'C0757844', 'cui_str': 'TNFSF13 protein, human'}, {'cui': 'C0010340', 'cui_str': 'Critical illness'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0009450', 'cui_str': 'Communicable disease'}, {'cui': 'C2362565', 'cui_str': 'Physiotherapist'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0205303', 'cui_str': 'Non-invasive'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0199467', 'cui_str': 'Physiotherapy of chest'}, {'cui': 'C0036085', 'cui_str': 'sodium chloride, hypertonic'}, {'cui': 'C0021778', 'cui_str': 'Intermittent positive pressure ventilation'}, {'cui': 'C0038638', 'cui_str': 'Suction drainage'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0028429', 'cui_str': 'Nasal'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0087153', 'cui_str': 'Ventilator'}, {'cui': 'C0205217', 'cui_str': 'Increased'}, {'cui': 'C0032740', 'cui_str': 'Positive end-expiratory pressure'}, {'cui': 'C2711254', 'cui_str': 'Nasal mask'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0015450', 'cui_str': 'Face structure'}, {'cui': 'C0199451', 'cui_str': 'Continuous positive airway pressure ventilation treatment'}]","[{'cui': 'C0231940', 'cui_str': 'Alveolar ventilation (V)'}, {'cui': 'C0441889', 'cui_str': 'Levels'}]",,0.189601,"In particular, we aim to explore if a NIOD performed by non-specialized personnel is not inferior to the standard chest physiotherapy (CPT) undertaken by physiotherapists caring for patients with COVID-19. ","[{'ForeName': 'Atsushi', 'Initials': 'A', 'LastName': 'Kawaguchi', 'Affiliation': 'Department of Pediatrics, University of Montreal, CHU Sainte-Justine, 3175 Chemin de Côte Sainte Catherine, Quebec, QB, H3T 1C5, Canada.'}, {'ForeName': 'Gabrielle', 'Initials': 'G', 'LastName': 'Bernier', 'Affiliation': 'School of Medicine, University of Montreal, Quebec, Canada.'}, {'ForeName': 'Jacques', 'Initials': 'J', 'LastName': 'Lacroix', 'Affiliation': 'Department of Pediatrics, University of Montreal, CHU Sainte-Justine, 3175 Chemin de Côte Sainte Catherine, Quebec, QB, H3T 1C5, Canada.'}, {'ForeName': 'Saly', 'Initials': 'S', 'LastName': 'El Salti', 'Affiliation': 'Department of Pediatrics, University of Montreal, CHU Sainte-Justine, 3175 Chemin de Côte Sainte Catherine, Quebec, QB, H3T 1C5, Canada.'}, {'ForeName': 'Matthew P', 'Initials': 'MP', 'LastName': 'Cheng', 'Affiliation': 'Divisions of Infectious Diseases and Medical Microbiology, McGill University Health Centre, Quebec, Canada.'}, {'ForeName': 'Todd C', 'Initials': 'TC', 'LastName': 'Lee', 'Affiliation': 'McGill Interdisciplinary Initiative in Infection and Immunity, Quebec, Canada.'}, {'ForeName': 'Kosar', 'Initials': 'K', 'LastName': 'Khwaja', 'Affiliation': 'Réseau de Recherche en Santé Respiratoire du Québec, Quebec, Canada.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Jouvet', 'Affiliation': 'Department of Pediatrics, University of Montreal, CHU Sainte-Justine, 3175 Chemin de Côte Sainte Catherine, Quebec, QB, H3T 1C5, Canada. philippe.jouvet@umontreal.ca.'}]",Trials,['10.1186/s13063-020-04533-6'] 2949,32620206,"[Intensification by high dose chemotherapy for germ-cell tumors, still an ongoing subject?]","More than 80 % of patient with metastatic germ cell tumor are cured with first line chemotherapy. Twenty to 30 % of patients will experience relapse or refractory disease with a very poor long-term prognosis. Most of them had metastatic germ cell tumors with a poor prognosis according to the international germ cell classification collaborative group (IGCCCG). The role of treatment intensification by high dose chemotherapy (HDCT) followed by stem cell rescue has not been demonstrated yet in the first line setting compared to standard chemotherapy. The role of HDCT in first or second salvage is also not yet demonstrated, many studies have been published in this situation with a lot of different regimen. Outside clinical trial, HDCT remains an option in salvage therapy, depending on many factors including prognostics factors, previous therapy, general condition and reference center consideration to select eligible patient who could benefit the most of this approach. Results from the international randomized trial TIGER will provide evidence-based information for HDCT strategy.",2020,The role of treatment intensification by high dose chemotherapy (HDCT) followed by stem cell rescue has not been demonstrated yet in the first line setting compared to standard chemotherapy.,[],"['high dose chemotherapy (HDCT', 'HDCT']",['experience relapse or refractory disease'],[],"[{'cui': 'C0444956', 'cui_str': 'High dose'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}]","[{'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0205269', 'cui_str': 'Intractable'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]",,0.0262045,The role of treatment intensification by high dose chemotherapy (HDCT) followed by stem cell rescue has not been demonstrated yet in the first line setting compared to standard chemotherapy.,"[{'ForeName': 'Armelle', 'Initials': 'A', 'LastName': 'Vinceneux', 'Affiliation': 'Département de cancérologie médicale, centre Léon-Bérard, 28, rue Laennec, 69008 Lyon, France. Electronic address: armelle.vinceneux@lyon.unicancer.fr.'}, {'ForeName': 'Mélodie', 'Initials': 'M', 'LastName': 'Carbonnaux', 'Affiliation': 'Département de cancérologie médicale, centre Léon-Bérard, 28, rue Laennec, 69008 Lyon, France.'}, {'ForeName': 'Aude', 'Initials': 'A', 'LastName': 'Fléchon', 'Affiliation': 'Département de cancérologie médicale, centre Léon-Bérard, 28, rue Laennec, 69008 Lyon, France.'}]",Bulletin du cancer,['10.1016/S0007-4551(20)30277-0'] 2950,32620210,Open-label randomized multi-center phase 2 study: gemcitabine cisplatin plus avelumab or gemcitabine cisplatin as first-line treatment of patients with locally advanced or metastatic urothelial bladder carcinoma: GCisAve.,"BACKGROUND The standard treatment in first line of advanced or metastatic urothelial bladder cancer (MBC) is the association of Gemcitabine and Cisplatin (GC). Avelumab, an anti-PD-L1 agent, has recently demonstrated efficacy. The objective is to evaluate the combination of these 3 agents. METHODS This phase II randomized open-label study, evaluated if GC-avelumab increases response rate and duration of response of patients in 1 st line treatment for MBC compared to GC. Severe toxicities should not overlap and be acceptable. The two co-primary end points are the objective response rate and the incidence of severe toxicity after six cycles of treatment. The study will recruit 90 participants, randomized in two arms (1:2), GC (gemcitabine 1 000 mg/m 2 /j, J1,J8, Cisplatine 70 mg/m 2 , J1 = J21), and GC-avelumab (10 mg/Kg/3 semaines). Randomization will be stratified on Karnofsky status (≥ 80 % vs. < 80 %) and visceral vs non visceral metastases. The duration of the inclusion period is 24 months, with a duration of participation of each patient of 18 months and a total study duration of 42 months. DISCUSSION If both efficacy and safety of the association of GC+avelumab are in the range of acceptable through this specific study design, this will support a subsequent randomized phase III study comparing both arms with an overall survival end-point. In addition, the evaluation of predictive parameters to be confirmed (e.g. the impact of tumor PD-L1 expression) or other immunological parameters, may support a selection of the population. NCT number : NCT03324282.",2020,The two co-primary end points are the objective response rate and the incidence of severe toxicity after six cycles of treatment.,"['patients with locally advanced or metastatic urothelial bladder carcinoma', '90 participants', 'first line of advanced or metastatic urothelial bladder cancer (MBC']","['GC-avelumab', 'Gemcitabine and Cisplatin (GC', 'GC+avelumab', 'GC (gemcitabine', 'gemcitabine cisplatin plus avelumab or gemcitabine cisplatin', 'J1,J8, Cisplatine 70 mg/m 2 , J1 = J21), and GC-avelumab']","['Severe toxicities', 'objective response rate and the incidence of severe toxicity', 'response rate and duration of response']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0699885', 'cui_str': 'Carcinoma of bladder'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0005684', 'cui_str': 'Malignant tumor of urinary bladder'}]","[{'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C4055417', 'cui_str': 'avelumab'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0040539', 'cui_str': 'TO'}, {'cui': 'C0018017', 'cui_str': 'Goal'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0449238', 'cui_str': 'Duration'}]",90.0,0.0457574,The two co-primary end points are the objective response rate and the incidence of severe toxicity after six cycles of treatment.,"[{'ForeName': 'Marine', 'Initials': 'M', 'LastName': 'Gross-Goupil', 'Affiliation': ""Service d'oncologie médicale, Hôpital Saint-André, CHU de Bordeaux, 1, rue Jean-Burguet, 33000 Bordeaux, France. Electronic address: marine.gross-goupil@chu-bordeaux.fr.""}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Domblides', 'Affiliation': ""Service d'oncologie médicale, Hôpital Saint-André, CHU de Bordeaux, 1, rue Jean-Burguet, 33000 Bordeaux, France; Université, Bordeaux, 146, rue Léo-Saignat, 33076 Bordeaux, France EudraCT number: 2017-002087-40.""}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Lefort', 'Affiliation': ""Service d'oncologie médicale, Hôpital Saint-André, CHU de Bordeaux, 1, rue Jean-Burguet, 33000 Bordeaux, France.""}, {'ForeName': 'Alain', 'Initials': 'A', 'LastName': 'Ravaud', 'Affiliation': ""Service d'oncologie médicale, Hôpital Saint-André, CHU de Bordeaux, 1, rue Jean-Burguet, 33000 Bordeaux, France; Université, Bordeaux, 146, rue Léo-Saignat, 33076 Bordeaux, France EudraCT number: 2017-002087-40.""}]",Bulletin du cancer,['10.1016/S0007-4551(20)30280-0'] 2951,32620212,BIONIKK: A phase 2 biomarker driven trial with nivolumab and ipilimumab or VEGFR tyrosine kinase inhibitor (TKI) in naïve metastatic kidney cancer.,"BACKGROUND The nivolumab-ipilimumab combination provides an overall response rate of 42% in first-line metastatic treatment of clear cell renal carcinoma (mccRCC). To date, there is no robust predictive biomarker of response to immune checkpoint inhibitor (ICI). In addition, severe autoimmune disorders occur more frequently with ICI combination than with ICI alone. The objective of this study is to compare the efficacy of ICI alone or in combination in patients according to tumor molecular characteristics. METHODS Using a 35-gene expression mRNA signature, patients were divided into 4 molecular groups (1 to 4). Patients in groups 1 and 4 were randomized to receive nivolumab alone (arms 1A and 4A) or nivolumab plus ipilimumab for 4 injections followed by nivolumab alone (arms 1B and 4B). Patients in groups 2 and 3 were randomized to receive nivolumab plus ipilimumab followed by nivolumab alone (arms 2B and 3B) or a tyrosine kinase inhibitor (sunitinib or pazopanib at the investigator's choice (arms 2C and 3C)). The main objective is the overall response rate by treatment and molecular group. DISCUSSION BIONIKK is the first trial in mccRCC to study the personalization of treatment with ICI or TKI according to tumor molecular characteristics in mccRCC. This trial is the most appropriate to prospectively identify biomarkers of response to nivolumab used alone or in combination or TKI monotherapy in patients with mccRCC. NCT02960906.",2020,"DISCUSSION BIONIKK is the first trial in mccRCC to study the personalization of treatment with ICI or TKI according to tumor molecular characteristics in mccRCC.","['naïve metastatic kidney cancer', '42% in first-line metastatic treatment of clear cell renal carcinoma (mccRCC', 'patients according to tumor molecular characteristics', 'patients with mccRCC', 'Using a 35-gene expression mRNA signature']","['nivolumab and ipilimumab or VEGFR tyrosine kinase inhibitor (TKI', 'nivolumab alone (arms 1A and 4A) or nivolumab plus ipilimumab', 'nivolumab alone (arms 1B and 4B', 'nivolumab plus ipilimumab followed by nivolumab alone (arms 2B and 3B) or a tyrosine kinase inhibitor (sunitinib or pazopanib', 'nivolumab used alone or in combination or TKI monotherapy', 'ICI']","['overall response rate', 'severe autoimmune disorders']","[{'cui': 'C0862448', 'cui_str': 'Renal cell carcinoma stage IV'}, {'cui': 'C0205132', 'cui_str': 'Linear'}, {'cui': 'C0036525', 'cui_str': 'Metastatic to'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0279702', 'cui_str': 'Clear cell carcinoma of kidney'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0017262', 'cui_str': 'Gene expression'}, {'cui': 'C0035696', 'cui_str': 'Messenger RNA'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}]","[{'cui': 'C3657270', 'cui_str': 'nivolumab'}, {'cui': 'C1367202', 'cui_str': 'ipilimumab'}, {'cui': 'C0148199', 'cui_str': 'Vascular Endothelial Growth Factor Receptor'}, {'cui': 'C1268567', 'cui_str': 'Protein-tyrosine kinase inhibitor'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0332282', 'cui_str': 'Following'}, {'cui': 'C1176020', 'cui_str': 'sunitinib'}, {'cui': 'C1831796', 'cui_str': 'pazopanib'}, {'cui': 'C0439662', 'cui_str': 'Immune'}, {'cui': 'C1155874', 'cui_str': 'Cell Cycle Checkpoints'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0004364', 'cui_str': 'Autoimmune disease'}]",,0.0774426,"DISCUSSION BIONIKK is the first trial in mccRCC to study the personalization of treatment with ICI or TKI according to tumor molecular characteristics in mccRCC.","[{'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Epaillard', 'Affiliation': 'Department of Medical Oncology, Hôpital Européen Georges Pompidou, APHP. Centre - Université de Paris, Paris, France.'}, {'ForeName': 'Audrey', 'Initials': 'A', 'LastName': 'Simonaggio', 'Affiliation': 'Department of Medical Oncology, Hôpital Européen Georges Pompidou, APHP. Centre - Université de Paris, Paris, France.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Elaidi', 'Affiliation': 'Association pour la Recherche de Thérapeutiques Innovantes en Cancérologie, Paris, France.'}, {'ForeName': 'Fouzia', 'Initials': 'F', 'LastName': 'Azzouz', 'Affiliation': 'Association pour la Recherche de Thérapeutiques Innovantes en Cancérologie, Paris, France.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Braychenko', 'Affiliation': 'Association pour la Recherche de Thérapeutiques Innovantes en Cancérologie, Paris, France.'}, {'ForeName': 'Constance', 'Initials': 'C', 'LastName': 'Thibault', 'Affiliation': 'Department of Medical Oncology, Hôpital Européen Georges Pompidou, APHP. Centre - Université de Paris, Paris, France.'}, {'ForeName': 'Cheng-Ming', 'Initials': 'CM', 'LastName': 'Sun', 'Affiliation': 'Centre de Recherche des Cordeliers, Université Paris 5, Sorbonne Université, Inserm U1138, F-75006 Paris, France.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Moreira', 'Affiliation': 'Centre de Recherche des Cordeliers, Université Paris 5, Sorbonne Université, Inserm U1138, F-75006 Paris, France.'}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Oudard', 'Affiliation': 'Department of Medical Oncology, Hôpital Européen Georges Pompidou, APHP. Centre - Université de Paris, Paris, France; INSERM U970. Paris Cardiovascular research Center (PARCC). Université Paris Descartes. Paris. France.'}, {'ForeName': 'Yann-Alexandre', 'Initials': 'YA', 'LastName': 'Vano', 'Affiliation': 'Department of Medical Oncology, Hôpital Européen Georges Pompidou, APHP. Centre - Université de Paris, Paris, France; Centre de Recherche des Cordeliers, Université Paris 5, Sorbonne Université, Inserm U1138, F-75006 Paris, France. Electronic address: yann.vano@aphp.fr.'}]",Bulletin du cancer,['10.1016/S0007-4551(20)30283-6'] 2952,32620213,Open-label phase II to evaluate the efficacy of NEoadjuvant dose-dense MVAC In cOmbination with durvalumab and tremelimumab in muscle-invasive urothelial carcinoma: NEMIO.,"BACKGROUND Neoadjuvant cisplatin-based chemotherapy (NAC) is the standard of care in localized muscle-invasive bladder cancer (MIBC). However, 60-70% of patients have residual tumor after NAC. Based on the overall response rate observed in the metastatic setting, ddMVAC is the most commonly used NAC regimen in Europe. The emergence of immune checkpoint inhibitor (ICI) in the metastatic setting raises the question if the combination of chemo plus ICI could increase the pCR rate. METHODS/DESIGN NEMIO is a French open-label randomized phase I/II trial assessing in the neoadjuvant setting the combination of ddMVAC plus durvalumab alone or with tremelimumab: 4 cycles of ddMVAC/2 weeks + 2 cycles of Durvalumab +/- Tremelimumab/4 weeks. Cystectomy is performed 4-8 weeks after the last dose of ddMVAC. Six pts will be included in each arm in a safety run-in cohort to evaluate the toxicity rate. Each arm will be expanded to a maximum of 60 pts. The primary endpoint of the safety run-in phase will be the rate of grade 3/4 treatment-related adverse events G3/4 TRAE. The primary endpoint of the phase II will be the pathological response rate and G 3/4 TRAE. Exploratory endpoints will include biomarkers of response and resistance to the combo. A total of 120 patients will be included in 15 French centers and we expect the recruitment to be completed in 2021. DISCUSSION NEMIO trial will assess for the first time the tolerance and the efficacy of ddMVAC regimen associated with checkpoints inhibitors as neoadjuvant treatment in localized MIBC. NCT number: NCT03549715. Registered on June 8, 2018.",2020,The primary endpoint of the safety run-in phase will be the rate of grade 3/4 treatment-related adverse events G3/4 TRAE.,"['muscle-invasive urothelial carcinoma', '120 patients will be included in 15 French centers and we expect the recruitment to be completed in 2021']","['durvalumab and tremelimumab', 'ddMVAC/2 weeks + 2 cycles of Durvalumab ', 'ddMVAC', 'Neoadjuvant cisplatin-based chemotherapy (NAC', 'ddMVAC plus durvalumab alone or with tremelimumab', 'NEoadjuvant dose-dense MVAC']","['pathological response rate and G 3/4 TRAE', 'pCR rate', 'safety run-in phase will be the rate of grade 3/4 treatment-related adverse events G3/4 TRAE', 'overall response rate', 'toxicity rate']","[{'cui': 'C0026845', 'cui_str': 'Muscle tissue'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C0007138', 'cui_str': 'Transitional cell carcinoma'}, {'cui': 'C4319550', 'cui_str': '120'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0376246', 'cui_str': 'French language'}, {'cui': 'C0205099', 'cui_str': 'Central'}]","[{'cui': 'C4055109', 'cui_str': 'durvalumab'}, {'cui': 'C2351038', 'cui_str': 'tremelimumab'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0600558', 'cui_str': 'Neoadjuvant therapy'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0439794', 'cui_str': 'Dense'}, {'cui': 'C0065452', 'cui_str': 'M-VAC protocol'}]","[{'cui': 'C0030664', 'cui_str': 'Pathology'}, {'cui': 'C0442757', 'cui_str': '3/4'}, {'cui': 'C0032520', 'cui_str': 'Polymerase chain reaction'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0441800', 'cui_str': 'Grade'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0040539', 'cui_str': 'TO'}]",120.0,0.0661061,The primary endpoint of the safety run-in phase will be the rate of grade 3/4 treatment-related adverse events G3/4 TRAE.,"[{'ForeName': 'Constance', 'Initials': 'C', 'LastName': 'Thibault', 'Affiliation': 'Department of medical oncology, HEGP, APHP.5 Paris. Electronic address: constance.thibault@aphp.fr.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Elaidi', 'Affiliation': 'Association pour la Recherche de Thérapeutiques Innovantes en Cancérologie, Paris.'}, {'ForeName': 'Yann-Alexandre', 'Initials': 'YA', 'LastName': 'Vano', 'Affiliation': 'Department of medical oncology, HEGP, APHP.5 Paris.'}, {'ForeName': 'Mouna', 'Initials': 'M', 'LastName': 'Rouabah', 'Affiliation': 'Association pour la Recherche de Thérapeutiques Innovantes en Cancérologie, Paris.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Braychenko', 'Affiliation': 'Association pour la Recherche de Thérapeutiques Innovantes en Cancérologie, Paris.'}, {'ForeName': 'Imen', 'Initials': 'I', 'LastName': 'Helali', 'Affiliation': 'Association pour la Recherche de Thérapeutiques Innovantes en Cancérologie, Paris.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Audenet', 'Affiliation': 'Department of urology, HEGP, APHP.5 Paris.'}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Oudard', 'Affiliation': 'Department of medical oncology, HEGP, APHP.5 Paris.'}]",Bulletin du cancer,['10.1016/S0007-4551(20)30281-2'] 2953,32620339,Hepatic Adaptation to Therapeutic Doses of acetaminophen: An Exploratory Study in healthy Individuals.,"PURPOSE Acetaminophen (APAP) has hepatotoxic potential when overdosed. Recent studies have reported serum alanine aminotransferase (ALT) elevations that resolve spontaneously with continued use of the drug, referred to as adaptation, in several individuals receiving therapeutic doses of APAP. However, the clinical significance of these ALT elevations remains unclear. This study was performed to investigate the incidence and characteristics of hepatic adaptation to therapeutic doses of APAP in healthy individuals. METHODS In a randomized, single-blind, placebo-controlled study, 242 healthy Japanese individuals were enrolled. Each person received 3 g/d of APAP (n = 202) or placebo (n = 40) for 28 days. All study participants underwent analysis of genetic polymorphisms of CYP2E1 and UGT1A1; measurements of plasma APAP concentration and urine metabolites (glucuronide, sulfate, cysteine, and mercapturate); liver function monitoring, including ALT, microRNA-122, and high-mobility group box 1. Individuals with ALT levels remaining below the upper limit of normal (ULN; 40 U/L) during the study period were defined as tolerant and those with ALT elevations above the ULN as susceptible. Susceptible individuals who developed ALT elevations exceeding 2 × ULN discontinued use of the study drug for tolerability consideration. Susceptible individuals who had ALT elevations that decreased toward the ULN spontaneously with continued use of the study drug were classified as adaptation. FINDINGS In the APAP group, 129 individuals (66%) were classified as tolerant and 65 (34%) as susceptible. Among 65 susceptible individuals, 12 (18%) discontinued use of APAP because of ALT elevations (>2 × ULN), whereas 53 (82%) completed 28-day APAP dosing. Thirty of 65 susceptible individuals (46%) had adaptation within 28 days. In the placebo group, no individuals was withdrawn from the study because of elevated ALT levels, 33 individuals (89%) were classified as tolerant, and 4 (11%) were classified as susceptible. None had clinical signs of liver injury. ALT level correlated significantly with microRNA-122 but not with high-mobility group box 1. No association was found between plasma APAP concentrations and ALT levels. Urinary excretion of APAP mercapturate was higher in susceptible than in tolerant individuals (P = 0.018, Wilcoxon or Kruskal-Wallis test). The frequency of homozygotes and compound heterozygotes for UGT1A1∗28 and UGT1A1∗6 (∗28/∗28, ∗6/∗6, and ∗6/∗28) was higher in susceptible than in tolerant individuals (13.9% vs 3.9%; P = 0.011, χ 2 test). IMPLICATIONS These findings indicate that in healthy individuals, APAP at a therapeutic dose can cause transient and self-limiting ALT elevation, reflecting subclinical hepatocellular damage, and these ALT elevations may be associated with the disposition of APAP metabolites and genetic factors. UMIN-CTR identifier: UMIN000019607.",2020,"Urinary excretion of APAP mercapturate was higher in susceptible than in tolerant individuals (P = 0.018, Wilcoxon or Kruskal-Wallis test).","['Thirty of 65 susceptible individuals (46%) had adaptation within 28 days', 'healthy Individuals', '242 healthy Japanese individuals were enrolled', 'healthy individuals']","['APAP', 'acetaminophen', 'Acetaminophen (APAP', 'placebo']","['plasma APAP concentration and urine metabolites (glucuronide, sulfate, cysteine, and mercapturate); liver function monitoring', 'clinical signs of liver injury', 'ALT elevations', 'serum alanine aminotransferase (ALT) elevations', 'plasma APAP concentrations and ALT levels', 'frequency of homozygotes and compound heterozygotes', 'ALT level', 'Urinary excretion of APAP mercapturate', 'elevated ALT levels']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0231204', 'cui_str': 'Susceptible'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0000934', 'cui_str': 'Acclimation'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C0376247', 'cui_str': 'Japanese language'}]","[{'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0042036', 'cui_str': 'Urine'}, {'cui': 'C0870883', 'cui_str': 'Metabolite'}, {'cui': 'C0752086', 'cui_str': 'Glucuronides'}, {'cui': 'C0038720', 'cui_str': 'Inorganic sulfate'}, {'cui': 'C0010654', 'cui_str': 'Cysteine'}, {'cui': 'C0232741', 'cui_str': 'Liver function'}, {'cui': 'C0150369', 'cui_str': 'Preventive monitoring'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0220912', 'cui_str': 'signs'}, {'cui': 'C0160390', 'cui_str': 'Injury of liver'}, {'cui': 'C0001899', 'cui_str': 'Alanine aminotransferase'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0237630', 'cui_str': 'Stimulus frequency'}, {'cui': 'C0019904', 'cui_str': 'Homozygote'}, {'cui': 'C0205198', 'cui_str': 'Compound'}, {'cui': 'C0019425', 'cui_str': 'Heterozygote'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}, {'cui': 'C1443982', 'cui_str': 'ALT (SGPT) level raised'}]",242.0,0.0368139,"Urinary excretion of APAP mercapturate was higher in susceptible than in tolerant individuals (P = 0.018, Wilcoxon or Kruskal-Wallis test).","[{'ForeName': 'Mika', 'Initials': 'M', 'LastName': 'Maeda', 'Affiliation': 'Kitasato University Graduate School of Medical Sciences, Kanagawa, Japan; Department of Pharmacy, Kitasato University Hospital, Kanagawa, Japan. Electronic address: m-maeda@kitasato-u.ac.jp.'}, {'ForeName': 'Rieko', 'Initials': 'R', 'LastName': 'Tanaka', 'Affiliation': 'Kitasato Clinical Research Center, Kitasato University School of Medicine, Kanagawa, Japan.'}, {'ForeName': 'Masako', 'Initials': 'M', 'LastName': 'Aso', 'Affiliation': 'Soleil Kawasaki Medical Center for the Handicapped, Kanagawa, Japan.'}, {'ForeName': 'Yasutoshi', 'Initials': 'Y', 'LastName': 'Sakamoto', 'Affiliation': 'Translational Research Support Section, National Cancer Center Hospital East, Chiba, Japan.'}, {'ForeName': 'Ildae', 'Initials': 'I', 'LastName': 'Song', 'Affiliation': 'Kitasato Clinical Research Center, Kitasato University School of Medicine, Kanagawa, Japan.'}, {'ForeName': 'Michiru', 'Initials': 'M', 'LastName': 'Ochiai', 'Affiliation': 'Kitasato University Graduate School of Medical Sciences, Kanagawa, Japan.'}, {'ForeName': 'Yoshiro', 'Initials': 'Y', 'LastName': 'Saito', 'Affiliation': 'Division of Medicinal Safety Science, National Institute of Health Sciences, Kanagawa, Japan.'}, {'ForeName': 'Keiko', 'Initials': 'K', 'LastName': 'Maekawa', 'Affiliation': 'Division of Medicinal Safety Science, National Institute of Health Sciences, Kanagawa, Japan.'}, {'ForeName': 'Noriaki', 'Initials': 'N', 'LastName': 'Arakawa', 'Affiliation': 'Division of Medicinal Safety Science, National Institute of Health Sciences, Kanagawa, Japan.'}, {'ForeName': 'Yasuo', 'Initials': 'Y', 'LastName': 'Ohno', 'Affiliation': 'Kihara Memorial Yokohama Foundation for the Advancement of Life Sciences, Kanagawa, Japan.'}, {'ForeName': 'Yuji', 'Initials': 'Y', 'LastName': 'Kumagai', 'Affiliation': 'Kitasato Clinical Research Center, Kitasato University School of Medicine, Kanagawa, Japan.'}]",Clinical therapeutics,['10.1016/j.clinthera.2020.05.003'] 2954,32620344,Short-term effects of atropine combined with orthokeratology (ACO) on choroidal thickness.,"PURPOSE To analyse the one-month change in subfoveal choroidal thickness (SFChT) of myopic children treated with 0.01 % atropine, orthokeratology (OK), or their combination. METHODS This is a prospective, randomized controlled trial. One hundred fifty-four children aged between 8 and 12 years with a spherical equivalent (SE) of -1.00 to -6.00 diopters were enrolled. Subjects were randomly assigned to receive 0.01 % atropine and orthokeratology (ACO, n = 39), 0.01 % atropine and single vision glasses (atropine, n = 42), orthokeratology and placebo (OK, n = 36), or placebo and single vision glasses (control, n = 37). SFChT was assessed using optical coherence tomography (OCT). Ocular parameters, including axial length (AL), were measured using a Lenstar LS 900. RESULTS SFChT significantly increased in the ACO (14.12 ± 12.88 μm, p < 0.001), OK (9.43 ± 9.14 μm, p < 0.001) and atropine (5.49 ± 9.38 μm, p < 0.001) groups, while it significantly decreased in the control group (-4.81 ± 9.93 μm, p = 0.006). The one-month change in SFChT was significantly different between the control and treatment groups (p < 0.001). The results of pairwise comparisons among the treatment groups showed that the magnitude of the SFChT change was larger in the ACO group than in the atropine group (p = 0.002). The changes in the ACO and OK groups were not significantly different (p = 0.326). CONCLUSION The combination of OK and atropine induced a greater increase in SFChT than monotherapy with atropine, which might indicate a better treatment effect for childhood myopia control.",2020,The one-month change in SFChT was significantly different between the control and treatment groups (p < 0.001).,['One hundred fifty-four children aged between 8 and 12 years with a spherical equivalent (SE) of -1.00 to -6.00 diopters were enrolled'],"['OK and atropine', 'SFChT', 'atropine and orthokeratology (ACO, n\u2009=\u200939), 0.01 % atropine and single vision glasses (atropine, n\u2009=\u200942), orthokeratology and placebo (OK, n\u2009=\u200936), or placebo and single vision glasses (control, n\u2009=\u200937', 'atropine, orthokeratology (OK), or their combination', 'atropine combined with orthokeratology (ACO', 'atropine']","['subfoveal choroidal thickness (SFChT', 'SFChT', 'Ocular parameters, including axial length (AL', 'OK', 'SFChT change', 'choroidal thickness', 'ACO']","[{'cui': 'C4321486', 'cui_str': '150'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0332501', 'cui_str': 'Spherical shape'}, {'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0439484', 'cui_str': 'Diopters'}]","[{'cui': 'C1533088', 'cui_str': 'Orthokeratology'}, {'cui': 'C0004259', 'cui_str': 'Atropine'}, {'cui': 'C0442185', 'cui_str': 'Subfoveal'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0054889', 'cui_str': 'CAV protocol'}, {'cui': 'C4517393', 'cui_str': '0.01'}, {'cui': 'C1275648', 'cui_str': 'Single vision glasses'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205195', 'cui_str': 'Combined'}]","[{'cui': 'C0442185', 'cui_str': 'Subfoveal'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0205131', 'cui_str': 'Axial'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C1533088', 'cui_str': 'Orthokeratology'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0054889', 'cui_str': 'CAV protocol'}]",154.0,0.138539,The one-month change in SFChT was significantly different between the control and treatment groups (p < 0.001).,"[{'ForeName': 'Wenchen', 'Initials': 'W', 'LastName': 'Zhao', 'Affiliation': 'State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Zhouyue', 'Initials': 'Z', 'LastName': 'Li', 'Affiliation': 'State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Yin', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': 'State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Jinyun', 'Initials': 'J', 'LastName': 'Jiang', 'Affiliation': 'State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Wen', 'Initials': 'W', 'LastName': 'Long', 'Affiliation': 'State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Dongmei', 'Initials': 'D', 'LastName': 'Cui', 'Affiliation': 'State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Weiyin', 'Initials': 'W', 'LastName': 'Chen', 'Affiliation': 'State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangzhou, China.'}, {'ForeName': 'Xiao', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': 'State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangzhou, China. Electronic address: Yangx_zoc@163.com.'}]",Contact lens & anterior eye : the journal of the British Contact Lens Association,['10.1016/j.clae.2020.06.006'] 2955,32620345,"Efficacy of a novel water propelled, heating eye mask massager on tear film and ocular adnexa.","PURPOSE To determine the effectiveness of the Aurai water propelled, heating Eye Massager (AEM) in managing dry eye disease and its effects on the ocular adnexa. METHODS This prospective, randomised cross-over study enrolled 15 participants (aged 25.8 ± 5.45 years, 5 male). Participants wore a smart watch 24 h a day to track their sleeping cycle and heart rate for 4 weeks, using the AEM twice a day for 2 of those weeks. A cycle of 6 min of a controlled heat and vibration pattern in the morning and another cycle in the evening were applied with the AEM. Primary outcomes of symptomatology (Ocular Surface Disease Index (OSDI) and Symptom Assessment iN Dry Eye (SANDE)), tear film and ocular surface homeostasis markers (osmolarity, non-invasive breakup time (NIKBUT), tear meniscus height (TMH), lipid layer thickness and ocular staining) and safety measures (ocular redness and intraocular pressure), were assessed at baseline, after 2 weeks of AEM use and after 2 weeks of no treatment (in random-sequence). Sleeping tracking (ST) and heart rate/blood oxygen detection over these periods was also assessed. RESULTS There was a significant change in OSDI score from 34.3 ± 19.5 at baseline to 18.8 ± 17.5 after treatment (p = 0.001) and also for the SANDE (5.7 ± 2.4 vs 3.7 ± 2.1; p = 0.001). Heart rate was not affected by treatment (p = 0.956), nor sleep pattern (p = 0.529), but this varied by day (p = 0.001). Tear film and ocular surface homeostasis, the ocular adnexia and safety measures were not affected by treatment (p > 0.05). CONCLUSION The Aurai water propelled Eye Massager may reduce the severity of symptoms of dry eye, but there were no detectable effects on tear stability and ocular surface disease from two weeks use.",2020,"Tear film and ocular surface homeostasis, the ocular adnexia and safety measures were not affected by treatment (p > 0.05). ","['15 participants (aged 25.8 ± 5.45 years, 5 male']","['novel water propelled, heating eye mask massager', 'Aurai water propelled, heating Eye Massager (AEM']","['Tear film and ocular surface homeostasis, the ocular adnexia and safety measures', 'OSDI score', 'tear stability and ocular surface disease', 'Heart rate', 'symptomatology (Ocular Surface Disease Index (OSDI) and Symptom Assessment iN Dry Eye (SANDE)), tear film and ocular surface homeostasis markers (osmolarity, non-invasive breakup time (NIKBUT), tear meniscus height (TMH), lipid layer thickness and ocular staining) and safety measures (ocular redness and intraocular pressure', 'sleep pattern', 'tear film and ocular adnexa', 'Sleeping tracking (ST) and heart rate/blood oxygen detection']","[{'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0020311', 'cui_str': 'Hydrotherapy'}, {'cui': 'C3204590', 'cui_str': 'Propel'}, {'cui': 'C0018851', 'cui_str': 'Heating'}, {'cui': 'C0181752', 'cui_str': 'Eye mask'}, {'cui': 'C0018837', 'cui_str': 'Heat'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}]","[{'cui': 'C0039409', 'cui_str': 'Tears'}, {'cui': 'C1704608', 'cui_str': 'Film'}, {'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0205148', 'cui_str': 'Surface'}, {'cui': 'C0019868', 'cui_str': 'Homeostasis'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C1557335', 'cui_str': 'Ocular surface disease'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C3494437', 'cui_str': 'Symptom Assessment'}, {'cui': 'C0013238', 'cui_str': 'Dry Eye Disease'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0029387', 'cui_str': 'Osmolarity'}, {'cui': 'C0205303', 'cui_str': 'Non-invasive'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C1827565', 'cui_str': 'Tear meniscus height'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C0038128', 'cui_str': 'Stain'}, {'cui': 'C0041834', 'cui_str': 'Erythema'}, {'cui': 'C0021888', 'cui_str': 'Intraocular pressure'}, {'cui': 'C0474396', 'cui_str': 'Sleep behavior finding'}, {'cui': 'C0229243', 'cui_str': 'Ocular adnexa structure'}, {'cui': 'C0037313', 'cui_str': 'Sleep'}, {'cui': 'C0005767', 'cui_str': 'Blood'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0206100', 'cui_str': 'Signal Detection (Psychology)'}]",15.0,0.0368583,"Tear film and ocular surface homeostasis, the ocular adnexia and safety measures were not affected by treatment (p > 0.05). ","[{'ForeName': 'Sònia', 'Initials': 'S', 'LastName': 'Travé-Huarte', 'Affiliation': 'Aston University, Birmingham, B4 7ET, UK. Electronic address: traveuhs@aston.ac.uk.'}, {'ForeName': 'James S', 'Initials': 'JS', 'LastName': 'Wolffsohn', 'Affiliation': 'Aston University, Birmingham, B4 7ET, UK. Electronic address: j.s.w.wolffsohn@aston.ac.uk.'}]",Contact lens & anterior eye : the journal of the British Contact Lens Association,['10.1016/j.clae.2020.06.002'] 2956,32620359,Randomized Controlled Trial of the Caregiver Orientation for Mobilizing Personal Assets and Strengths for Self-Care (COMPASS) for Caregiving Journey: A National Family Caregiver Support Program in a Long-Term Care Insurance System.,"OBJECTIVES To investigate the effects of a national support program on family caregivers for long-term care (LTC) recipients. DESIGN A single-blinded randomized controlled trial compared the 8-week Caregiver Orientation for Mobilizing Personal Assets and Strengths for Self-Care (COMPASS) program consisting of 6 individual in-home, 3 group support, and 2 telephone sessions with a multicomponent intervention, and a control group. SETTING AND PARTICIPANTS In total, 969 caregivers who were living with LTC recipients assessed as having a high caregiving burden in 12 Korean cities. MEASURES The primary outcomes were depression, burden, and stress levels of caregivers, the secondary outcomes were caregiver self-efficacy, positive aspects of caregiving, social support, social activities, and health risk behaviors. These outcomes were measured at baseline and after the 8-week program, analyzed using modified intention-to-treat, per-protocol (PP), and non-PP analyses. RESULTS The modified intention-to-treat analysis revealed significant improvements in burden (effect size, = 0.010, P = .008), depression (η p 2  = 0.012, P = .003), and health risk behaviors (η p 2  = 0.010, P = .012) for the experimental group compared with the control group. However, there were no significant differences between the 2 groups in improving stress (P = .997), social support (P = .234), or social activities (P = .816). The PP analysis indicated that the COMPASS program was successful in increasing positive aspects of caregiving (η p 2  = 0.013, P = .004) and self-efficacy (η p 2  = 0.010, P = .032) compared with the control group. CONCLUSIONS AND IMPLICATIONS The COMPASS program was effective in family caregivers of LTC recipients in critical aspects of physical and psychological outcomes, especially in demonstrating the important role of participating in group support sessions. It is feasible for the program to become a formal national support program as part of the national insurance system in Republic of Korea.",2020,"However, there were no significant differences between the 2 groups in improving stress (P = .997), social support (P = .234), or social activities (P = .816).","['969 caregivers who were living with LTC recipients assessed as having a high caregiving burden in 12 Korean cities', 'Caregiving Journey', 'family caregivers for long-term care (LTC) recipients']","['Caregiver Orientation for Mobilizing Personal Assets and Strengths for Self-Care (COMPASS', '8-week Caregiver Orientation for Mobilizing Personal Assets and Strengths for Self-Care (COMPASS) program consisting of 6 individual in-home, 3 group support, and 2 telephone sessions with a multicomponent intervention, and a control group', 'national support program', 'COMPASS program']","['depression, burden, and stress levels of caregivers, the secondary outcomes were caregiver self-efficacy, positive aspects of caregiving, social support, social activities, and health risk behaviors', 'improving stress', 'positive aspects of caregiving', 'health risk behaviors', 'self-efficacy', 'social activities', 'depression', 'social support']","[{'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}, {'cui': 'C0062074', 'cui_str': 'HAC protocol'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0022774', 'cui_str': 'Korean language'}, {'cui': 'C0008848', 'cui_str': 'Cities'}, {'cui': 'C0086279', 'cui_str': 'Family Caregivers'}]","[{'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0029266', 'cui_str': 'Orientation'}, {'cui': 'C0185112', 'cui_str': 'Mobilization'}, {'cui': 'C0036592', 'cui_str': 'Self-care interventions'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0332529', 'cui_str': 'Consistency'}, {'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0442519', 'cui_str': 'Domestic'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0039457', 'cui_str': 'Telephone'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0015737', 'cui_str': 'National Government'}]","[{'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C1319127', 'cui_str': 'Level of stress'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C1446409', 'cui_str': 'Positive'}, {'cui': 'C0037438', 'cui_str': 'Social support'}, {'cui': 'C0026606', 'cui_str': 'Physical activity'}, {'cui': 'C4505097', 'cui_str': 'Health Risk Behaviors'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0038435', 'cui_str': 'Stress'}]",969.0,0.0558047,"However, there were no significant differences between the 2 groups in improving stress (P = .997), social support (P = .234), or social activities (P = .816).","[{'ForeName': 'Eun-Jeong', 'Initials': 'EJ', 'LastName': 'Han', 'Affiliation': 'Health Insurance Policy Research Institute, National Health Insurance Service, Wonju, Republic of Korea.'}, {'ForeName': 'Myonghwa', 'Initials': 'M', 'LastName': 'Park', 'Affiliation': 'College of Nursing, Chungnam National University, Daejeon, Republic of Korea. Electronic address: mhpark@cnu.ac.kr.'}, {'ForeName': 'Seyoung', 'Initials': 'S', 'LastName': 'Park', 'Affiliation': 'Health Insurance Policy Research Institute, National Health Insurance Service, Wonju, Republic of Korea.'}, {'ForeName': 'Thi-Thanh-Tinh', 'Initials': 'TT', 'LastName': 'Giap', 'Affiliation': 'College of Nursing, Chungnam National University, Daejeon, Republic of Korea.'}, {'ForeName': 'Duhee', 'Initials': 'D', 'LastName': 'Han', 'Affiliation': 'Korean Ministry of Health and Welfare, Sejong, Republic of Korea.'}]",Journal of the American Medical Directors Association,['10.1016/j.jamda.2020.05.011'] 2957,32620666,Prognostic Impact of Geriatric Nutritional Risk Index in Patients With Synchronous Colorectal Liver Metastasis.,"BACKGROUND/AIM The Geriatric Nutritional Risk Index (GNRI) is a prognostic indicator for several cancers; however, the association between the GNRI and colorectal liver metastasis (CRLM) remains unknown. PATIENTS AND METHODS Eighty patients who underwent hepatectomy for synchronous CRLM were divided into two groups based on the GNRI. RESULTS The preoperative CA19-9 levels were significantly higher in the low (GNRI ≤98; n=30) than the normal GNRI group (GNRI >98; n=50). Patients in the low GNRI group had poorer outcomes than those in the normal GNRI group. A low GNRI was an independent prognostic factor for recurrence-free survival and overall survival. Among 50 patients who experienced recurrence, only 16 of 22 patients (72.7%) in the low GNRI group could receive intensive treatment and 27 of 28 patients (96.4%) in the normal GNRI group. CONCLUSION The GNRI is a simplified prognostic factor for patients with CRLM.",2020,The preoperative CA19-9 levels were significantly higher in the low (GNRI ≤98; n=30) than the normal GNRI group (GNRI >98; n=50).,"['Eighty patients who underwent hepatectomy for synchronous CRLM', 'Patients With Synchronous Colorectal Liver Metastasis', 'patients with CRLM']",['Geriatric Nutritional Risk Index'],"['recurrence-free survival and overall survival', 'preoperative CA19-9 levels']","[{'cui': 'C3816958', 'cui_str': '80'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0019144', 'cui_str': 'Liver excision'}, {'cui': 'C0439580', 'cui_str': 'Synchronous'}, {'cui': 'C0555952', 'cui_str': 'Colorectal'}, {'cui': 'C0494165', 'cui_str': 'Secondary malignant neoplasm of liver'}]","[{'cui': 'C0017469', 'cui_str': 'Geriatric medicine'}, {'cui': 'C1268620', 'cui_str': 'At risk for nutritional problem'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]","[{'cui': 'C2919733', 'cui_str': 'Surviving free of recurrence of neoplastic disease'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0038952', 'cui_str': 'Survival'}, {'cui': 'C0445204', 'cui_str': 'Preoperative'}, {'cui': 'C0201551', 'cui_str': 'Cancer antigen 19-9 measurement'}]",80.0,0.0206835,The preoperative CA19-9 levels were significantly higher in the low (GNRI ≤98; n=30) than the normal GNRI group (GNRI >98; n=50).,"[{'ForeName': 'Tomohiro', 'Initials': 'T', 'LastName': 'Iguchi', 'Affiliation': 'Department of Hepato-Biliary Pancreatic Surgery, National Hospital Organization Kyushu Cancer Center, Fukuoka, Japan tomo@surg2.med.kyushu-u.ac.jp.'}, {'ForeName': 'Keishi', 'Initials': 'K', 'LastName': 'Sugimachi', 'Affiliation': 'Department of Hepato-Biliary Pancreatic Surgery, National Hospital Organization Kyushu Cancer Center, Fukuoka, Japan.'}, {'ForeName': 'Yohei', 'Initials': 'Y', 'LastName': 'Mano', 'Affiliation': 'Department of Hepato-Biliary Pancreatic Surgery, National Hospital Organization Kyushu Cancer Center, Fukuoka, Japan.'}, {'ForeName': 'Takashi', 'Initials': 'T', 'LastName': 'Motomura', 'Affiliation': 'Department of Surgery and Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.'}, {'ForeName': 'Masahiko', 'Initials': 'M', 'LastName': 'Sugiyama', 'Affiliation': 'Department of Gastroenterological Surgery, National Hospital Organization Kyushu Cancer Center, Fukuoka, Japan.'}, {'ForeName': 'Mitsuhiko', 'Initials': 'M', 'LastName': 'Ota', 'Affiliation': 'Department of Gastroenterological Surgery, National Hospital Organization Kyushu Cancer Center, Fukuoka, Japan.'}, {'ForeName': 'Masahiko', 'Initials': 'M', 'LastName': 'Ikebe', 'Affiliation': 'Department of Gastroenterological Surgery, National Hospital Organization Kyushu Cancer Center, Fukuoka, Japan.'}, {'ForeName': 'Taito', 'Initials': 'T', 'LastName': 'Esaki', 'Affiliation': 'Department of Gastrointestinal and Medical Oncology National Hospital Organization Kyushu Cancer Center, Fukuoka, Japan.'}, {'ForeName': 'Tomoharu', 'Initials': 'T', 'LastName': 'Yoshizumi', 'Affiliation': 'Department of Surgery and Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.'}, {'ForeName': 'Masaru', 'Initials': 'M', 'LastName': 'Morita', 'Affiliation': 'Department of Gastroenterological Surgery, National Hospital Organization Kyushu Cancer Center, Fukuoka, Japan.'}, {'ForeName': 'Masaki', 'Initials': 'M', 'LastName': 'Mori', 'Affiliation': 'Department of Surgery and Science, Graduate School of Medical Sciences, Kyushu University, Fukuoka, Japan.'}, {'ForeName': 'Yasushi', 'Initials': 'Y', 'LastName': 'Toh', 'Affiliation': 'Department of Gastroenterological Surgery, National Hospital Organization Kyushu Cancer Center, Fukuoka, Japan.'}]",Anticancer research,['10.21873/anticanres.14416'] 2958,32620716,Comparison between mesh fixation and non-fixation in patients undergoing total extraperitoneal inguinal hernia repair.,"Background The most important advantages of laparoscopic hernia repair include less postoperative pain, good cosmetic results, and early return to daily activities. Different methods and mesh types are used in inguinal hernia repair. Aims The objective of this study was to evaluate the complications and recurrence rates in patients who underwent laparoscopic inguinal hernia repair with and without mesh fixation. Subjects and Methods A total of 183 patients who underwent total extraperitoneal (TEP) inguinal hernia repair in the general surgery clinic between January 2012 and January 2015 patients operated due to inguinoscrotal hernia and those lost to follow-up were excluded from the study. Patients were divided into two groups. Group 1 consisted of patients in whom 3D (Bard 3D Max) mesh was used and fixed with symphysis pubis absorbable tucker, while group 2 included patients without mesh fixation. All statistical analyses were performed using SPSS 22.0 statistical package software. The differences were considered statistically significant if the P value was less than 0.05. Results In the study, 178 patients were included. The median age was 48 years. Of all patients, 98 had right-sided, 72 left-sided, and eight bilateral hernias. The mean follow-up duration was 45 months. The demographic data between the groups were similar. Operation time was 51.82 ± 18.87 min in group 1 and 52 ± 19.92 in group 2 (P = 0.089). No statistically significant difference was found between both groups in terms of the development of early and late complications. Intraoperative complications, port-site hernia, and mortality were not seen in any patient. Conclusion TEP seems to be a safe and effective surgical approach in inguinal hernia treatment with acceptable operation times and postoperative results. It was determined that not performing mesh fixation in the TEP application did not cause a statistical increase in morbidity and recurrence rates.",2020,It was determined that not performing mesh fixation in the TEP application did not cause a statistical increase in morbidity and recurrence rates.,"['in the general surgery clinic between January 2012 and January 2015 patients operated due to inguinoscrotal hernia and those lost to follow-up were excluded from the study', 'patients undergoing total extraperitoneal inguinal hernia repair', 'patients who underwent', 'Of all patients, 98 had right-sided, 72 left-sided, and eight bilateral hernias', 'Subjects and Methods\n\n\nA total of 183 patients who underwent', '178 patients were included']","['mesh fixation and non-fixation', 'laparoscopic inguinal hernia repair with and without mesh fixation', 'laparoscopic hernia repair', 'total extraperitoneal (TEP) inguinal hernia repair', 'symphysis pubis absorbable tucker, while group 2 included patients without mesh fixation']","['complications and recurrence rates', 'morbidity and recurrence rates', 'Intraoperative complications, port-site hernia, and mortality', 'development of early and late complications', 'Operation time']","[{'cui': 'C3840262', 'cui_str': 'General surgery clinic'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0019270', 'cui_str': 'Hernia'}, {'cui': 'C1302313', 'cui_str': 'Lost to follow-up'}, {'cui': 'C0332196', 'cui_str': 'Exclude'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0442090', 'cui_str': 'Extraperitoneal'}, {'cui': 'C0021446', 'cui_str': 'Repair of inguinal hernia'}, {'cui': 'C0205090', 'cui_str': 'Right'}, {'cui': 'C0205091', 'cui_str': 'Left'}, {'cui': 'C0238767', 'cui_str': 'Right and left'}, {'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C4517615', 'cui_str': '183'}, {'cui': 'C0332257', 'cui_str': 'Including'}]","[{'cui': 'C0181805', 'cui_str': 'Mesh'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0031150', 'cui_str': 'Laparoscopy'}, {'cui': 'C0021446', 'cui_str': 'Repair of inguinal hernia'}, {'cui': 'C0019328', 'cui_str': 'Hernia repair'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0442090', 'cui_str': 'Extraperitoneal'}, {'cui': 'C0224520', 'cui_str': 'Symphysis structure'}, {'cui': 'C0034014', 'cui_str': 'Bone structure of pubis'}, {'cui': 'C0441865', 'cui_str': 'Group 2'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0034897', 'cui_str': 'Recurrence'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0021890', 'cui_str': 'Intraoperative complication'}, {'cui': 'C0452253', 'cui_str': 'Port'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0019270', 'cui_str': 'Hernia'}, {'cui': 'C0026565', 'cui_str': 'Mortality rate'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0205087', 'cui_str': 'Late'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0040223', 'cui_str': 'Time'}]",178.0,0.0514192,It was determined that not performing mesh fixation in the TEP application did not cause a statistical increase in morbidity and recurrence rates.,"[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Acar', 'Affiliation': 'Health Science University, Umraniye Education and Research Hospital, Department of General Surgery, Istanbul, Turkey.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Kabak', 'Affiliation': 'Health Science University, Umraniye Education and Research Hospital, Department of General Surgery, Istanbul, Turkey.'}, {'ForeName': 'H K', 'Initials': 'HK', 'LastName': 'Tolan', 'Affiliation': 'Health Science University, Umraniye Education and Research Hospital, Department of General Surgery, Istanbul, Turkey.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Canbak', 'Affiliation': 'Health Science University, Umraniye Education and Research Hospital, Department of General Surgery, Istanbul, Turkey.'}]",Nigerian journal of clinical practice,['10.4103/njcp.njcp_398_19'] 2959,32620717,The effect of different mouthwashes on bacteremia after debonding.,"Objectives This study aims to investigate the effects of various mouthwashes on bacteremia development following a debonding process, which is performed after orthodontic treatment. Subjects and Methods The study included patients who received fixed orthodontic treatment and were indicated for debonding. A total of 40 patients in four groups were selected for the study; no mouthwash (Group 1), mouthwash containing 0.12% chlorhexidine-gluconate (Group 2), mouthwash containing essential-oils (Group 3), and mouthwash containing 7.5% povidone-iodine (Group 4). Before (T 0 ) and following (T 1 ) the debonding procedure, blood samples were obtained from the patients. Then, the blood samples were placed in blood culture bottles to investigate bacterial growth. Results Based on the results of the study, it was determined that the blood samples obtained at T 0 did not indicate any bacterial growth. Furthermore, it was observed that the blood samples obtained at T 1 included Streptococcus viridans, Streptococcus oralis, Streptococcus mutans, and Staphylococcus aereus growth, respectively, in 4 patients from Group 1 while Streptococcus salivarius growth was observed in 1 patient from Group 3 in addition to Streptococcus mitis growth in 1 patient from Group 4. No bacterial growth was observed in Group 2. While the results obtained between Group 1 and Group 2 were statistically significant, no statistically significant difference was observed between other groups. Conclusions Finally, it was determined that the mouthwash 0.12% chlorhexidine-gluconate was statistically significant in comparison to the control group. It can be concluded that this mouthwash can be used to decrease bacterial density in oral flora before debonding procedures.",2020,"While the results obtained between Group 1 and Group 2 were statistically significant, no statistically significant difference was observed between other groups. ","['Subjects and Methods', '40 patients in four groups were selected for the study; no mouthwash (Group 1']","['mouthwash containing 0.12% chlorhexidine-gluconate', 'chlorhexidine-gluconate', 'mouthwash containing essential-oils (Group 3), and mouthwash containing 7.5% povidone-iodine', 'fixed orthodontic treatment']","['bacteremia', 'bacterial growth', 'Streptococcus salivarius growth', 'bacteremia development']","[{'cui': 'C0025663', 'cui_str': 'Method'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0026647', 'cui_str': 'Oromucosal solution for gargle'}, {'cui': 'C0441861', 'cui_str': 'Group 1'}]","[{'cui': 'C0026647', 'cui_str': 'Oromucosal solution for gargle'}, {'cui': 'C0332256', 'cui_str': 'Containing'}, {'cui': 'C4517426', 'cui_str': '0.12'}, {'cui': 'C0055361', 'cui_str': 'Chlorhexidine gluconate'}, {'cui': 'C0028910', 'cui_str': 'Volatile oil'}, {'cui': 'C0441869', 'cui_str': 'Group 3'}, {'cui': 'C4517859', 'cui_str': '7.5'}, {'cui': 'C0032857', 'cui_str': 'Povidone-Iodine'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0204193', 'cui_str': 'Orthodontic procedure'}]","[{'cui': 'C0004610', 'cui_str': 'Bacteremia'}, {'cui': 'C0427944', 'cui_str': 'Determination of bacterial growth'}, {'cui': 'C0318179', 'cui_str': 'Streptococcus salivarius'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0018271', 'cui_str': 'Growth and Development'}]",40.0,0.0236568,"While the results obtained between Group 1 and Group 2 were statistically significant, no statistically significant difference was observed between other groups. ","[{'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Akbulut', 'Affiliation': 'Department of Orthodontics, Fırat University, Elazıǧ, Turkey.'}]",Nigerian journal of clinical practice,['10.4103/njcp.njcp_664_19'] 2960,32620810,Effect of occlusal splint on oxidative stress markers and psychological aspects of chronic temporomandibular pain: a randomized controlled trial.,"Temporomandibular disorders (TMD), when progress to a chronic state, might contribute to psychosocial or psychological distress. This study aimed to evaluate the effect of stabilization splint (SS) therapy on pain, pain-related disability and psychological traits of chronic TMD patients, as well as to assess selected oxidative stress (OS) biomarkers during 6-month treatment and associate them with the symptoms of anxiety and depression. Thirty-four participants were randomly assigned into two treatment groups [SS and placebo splint (PS)]. Primary outcomes were pain intensity and pain-related disability while secondary outcomes included depressive and anxiety symptoms. The influence of the treatment type was analyzed with regards to the levels of OS biomarkers in saliva. Participants treated with SS demonstrated significantly greater improvement in pain-related disability (Pain-free mouth opening: p = 0.018, η 2  = 0.166; Number of disability days: p = 0.023, η 2  = 0.155) and greater reduction of depressive symptoms scores (p = 0.007, η 2  = 0.207). When compared to the PS group, participants in the SS group showed a significant reduction of oxidant/antioxidant ratio (p = 0.018, η 2  = 0.167) at a 3-month follow-up. A stabilization splint provides advantages over PS in the treatment of depressive symptoms and pain-related disability. Furthermore, clinical success in terms of reduction of depressive symptoms, which correlates with the reduction of oxidative stress markers in the SS group, indicates that oxidative stress is related to psychological factors in chronic TMD patients.",2020,"Participants treated with SS demonstrated significantly greater improvement in pain-related disability (Pain-free mouth opening: p = 0.018, η 2  = 0.166; Number of disability days: p = 0.023, η 2  = 0.155) and greater reduction of depressive symptoms scores (p = 0.007, η 2  = 0.207).","['Thirty-four participants', 'chronic temporomandibular pain', 'chronic TMD patients', 'Temporomandibular disorders (TMD']","['occlusal splint', 'stabilization splint (SS) therapy', 'SS', 'placebo splint (PS', 'stabilization splint']","['oxidative stress markers', 'depressive symptoms scores', 'pain intensity and pain-related disability', 'oxidative stress (OS) biomarkers', 'depressive and anxiety symptoms', 'pain, pain-related disability and psychological traits', 'pain-related disability', 'oxidant/antioxidant ratio']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0039494', 'cui_str': 'Temporomandibular joint disorder'}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0162528', 'cui_str': 'Occlusal appliance'}, {'cui': 'C1293130', 'cui_str': 'Stabilization'}, {'cui': 'C0038009', 'cui_str': 'Splint'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0205486', 'cui_str': 'Psychologic'}, {'cui': 'C0085403', 'cui_str': 'Oxidizing Agents'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",34.0,0.0633455,"Participants treated with SS demonstrated significantly greater improvement in pain-related disability (Pain-free mouth opening: p = 0.018, η 2  = 0.166; Number of disability days: p = 0.023, η 2  = 0.155) and greater reduction of depressive symptoms scores (p = 0.007, η 2  = 0.207).","[{'ForeName': 'Iva Z', 'Initials': 'IZ', 'LastName': 'Alajbeg', 'Affiliation': 'Department of Removable Prosthodontics, School of Dental Medicine, University of Zagreb, Gundulićeva 5, 10 000, Zagreb, Croatia.'}, {'ForeName': 'Ema', 'Initials': 'E', 'LastName': 'Vrbanović', 'Affiliation': 'Department of Removable Prosthodontics, School of Dental Medicine, University of Zagreb, Gundulićeva 5, 10 000, Zagreb, Croatia. evrbanovic@sfzg.hr.'}, {'ForeName': 'Ivana', 'Initials': 'I', 'LastName': 'Lapić', 'Affiliation': 'Medical Biochemistry and Laboratory Medicine, Department of Laboratory Diagnostics, University Hospital Centre Zagreb (KBCZ), Zagreb, Croatia.'}, {'ForeName': 'Ivan', 'Initials': 'I', 'LastName': 'Alajbeg', 'Affiliation': 'Department of Oral Medicine, School of Dental Medicine, University of Zagreb, Zagreb, Croatia.'}, {'ForeName': 'Lea', 'Initials': 'L', 'LastName': 'Vuletić', 'Affiliation': 'Department of Physiology, School of Dental Medicine, University of Zagreb, Zagreb, Croatia.'}]",Scientific reports,['10.1038/s41598-020-67383-x'] 2961,32620335,Effects of Probiotics on Malnutrition and Health-Related Quality of Life in Patients Undergoing Peritoneal Dialysis: A Randomized Controlled Trial.,"OBJECTIVE Alterations in the gut microbiota and host responses have been implicated in the progression of end-stage renal disease, increased cardiovascular risk, uremic toxicity, and inflammation. The purpose of this study was to evaluate the clinical efficacy of probiotics on malnutrition and health-related quality of life in patients undergoing peritoneal dialysis (PD). DESIGN AND METHODS A total of 116 patients undergoing PD were randomly divided into an intervention group (n = 58) and a control group (n = 58). The intervention group received a daily dose of probiotics (1 × 10 9  CFU/day, i.e., 2 capsules, tid) for 2 months, while the control group did not receive probiotics during the same period. Biochemical indicators, physical measurements, and scores on the SF-36 were measured before and 2 months after the intervention. RESULTS A total of 98 patients completed the study (50 in the intervention group and 48 in the control group). Among patients receiving probiotics, the levels of high-sensitivity C-reactive protein and interleukin-6 decreased after 2 months of treatment, while the serum albumin levels, upper arm circumference, and triceps skinfold thickness increased significantly. The probiotic group had higher scores on the physical functioning and social functioning domains than the control group after 2 months. CONCLUSIONS Probiotics could significantly decrease the serum levels of high-sensitivity C-reactive protein and interleukin-6 and increase the serum albumin levels, upper arm circumference, and triceps skinfold thickness in patients undergoing PD. As a result, malnutrition and health-related quality of life partially improved after probiotic supplementation in patients undergoing PD.",2020,"Among patients receiving probiotics, the levels of high-sensitivity C-reactive protein and interleukin-6 decreased after 2 months of treatment, while the serum albumin levels, upper arm circumference, and triceps skinfold thickness increased significantly.","['98 patients completed the study (50 in the intervention group and 48 in the control group', '116 patients undergoing PD', 'patients undergoing peritoneal dialysis (PD', 'Patients Undergoing Peritoneal Dialysis', 'patients undergoing PD']","['Probiotics', 'probiotics', 'probiotic supplementation']","['Malnutrition and Health-Related Quality of Life', 'serum albumin levels, upper arm circumference, and triceps skinfold thickness', 'physical functioning and social functioning domains', 'Biochemical indicators, physical measurements, and scores on the SF-36', 'levels of high-sensitivity C-reactive protein and interleukin-6', 'malnutrition and health-related quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4517541', 'cui_str': '116'}, {'cui': 'C0031139', 'cui_str': 'Peritoneal dialysis'}]","[{'cui': 'C0525033', 'cui_str': 'Probiotic'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}]","[{'cui': 'C0162429', 'cui_str': 'Undernourished'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0523465', 'cui_str': 'Albumin measurement, serum'}, {'cui': 'C0230348', 'cui_str': 'Both upper arms'}, {'cui': 'C0332520', 'cui_str': 'Circumference'}, {'cui': 'C0518022', 'cui_str': 'Triceps skin fold thickness'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0031843', 'cui_str': 'PH'}, {'cui': 'C0037395', 'cui_str': 'Social adjustment'}, {'cui': 'C1514562', 'cui_str': 'Protein Domain'}, {'cui': 'C0205474', 'cui_str': 'Biochemical'}, {'cui': 'C0021212', 'cui_str': 'Indicators'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0020517', 'cui_str': 'Hypersensitivity reaction'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}]",116.0,0.0951742,"Among patients receiving probiotics, the levels of high-sensitivity C-reactive protein and interleukin-6 decreased after 2 months of treatment, while the serum albumin levels, upper arm circumference, and triceps skinfold thickness increased significantly.","[{'ForeName': 'Yangbin', 'Initials': 'Y', 'LastName': 'Pan', 'Affiliation': 'Department of Nephrology, Shanghai Pudong Hospital, Fudan University Pudong Medical Center, Shanghai, China; Department of Nephrology, the First Affiliated Hospital of Fujian Medical University, Fuzhou, China. Electronic address: panyb9999@126.com.'}, {'ForeName': 'Liyan', 'Initials': 'L', 'LastName': 'Yang', 'Affiliation': 'Department of Nephrology, the First Affiliated Hospital of Fujian Medical University, Fuzhou, China.'}, {'ForeName': 'Binbin', 'Initials': 'B', 'LastName': 'Dai', 'Affiliation': 'Department of Nephrology, the First Affiliated Hospital of Fujian Medical University, Fuzhou, China.'}, {'ForeName': 'Beiduo', 'Initials': 'B', 'LastName': 'Lin', 'Affiliation': 'Department of Nephrology, the First Affiliated Hospital of Fujian Medical University, Fuzhou, China.'}, {'ForeName': 'Songhua', 'Initials': 'S', 'LastName': 'Lin', 'Affiliation': 'Department of Nephrology, the First Affiliated Hospital of Fujian Medical University, Fuzhou, China.'}, {'ForeName': 'Enqin', 'Initials': 'E', 'LastName': 'Lin', 'Affiliation': 'Department of Nephrology, the First Affiliated Hospital of Fujian Medical University, Fuzhou, China.'}]",Journal of renal nutrition : the official journal of the Council on Renal Nutrition of the National Kidney Foundation,['10.1053/j.jrn.2020.04.008'] 2962,32620370,Evaluation of effectiveness of three-dimensional printed ear splint therapy following ear elevation surgery in microtia patients: A randomized controlled trial.,"AIM This study aimed to compare the effectiveness of a 3D-printed ear splint with that of a conventional thermoplastic ear splint after microtia reconstruction. METHODS Patients who underwent ear elevation surgery with postauricular fascia coverage between October 2017 and October 2018 were included. They were randomly divided into the experimental group (3D-printed ear splint) and the control group (thermoplastic ear splint) and underwent routine postoperative rehabilitation and antiscar therapy. Splint therapy was initiated 4 weeks postoperatively and continued until 24 weeks postoperatively. The evaluated indices were the Vancouver scar scale score (VSS score), cranioauricular distance, patient compliance, complications (dermatitis, skin ulcers, skin necrosis), and patient satisfaction. A two-group t-test was carried out to compare all variables except patient satisfaction, which was compared using the Mann-Whitney U-test; p < 0.05 was considered significant. RESULTS Twenty patients were included in each group. At 4 weeks postoperatively, the VSS score (p = 0.748) and cranioauricular distance (p = 0.647) showed no significant differences between the groups. At 24 weeks postoperatively, the mean VSS scores were 4.85 ± 1.46 and 6.25 ± 1.74 (p = 0.009), the mean cranioauricular distances were 15.80 ± 1.82 mm and 13.95 ± 1.93 mm (p = 0.004), and the patient satisfaction scores were 4.5 ± 0.51 and 3.7 ± 0.47 (p < 0.001) in the experimental group and the control group, respectively, all showing significant differences. Two patients in each group exhibited skin irritation or skin ulcers, which resolved after 6 months of follow-up. CONCLUSION The application of 3D-printed ear splints provides better inhibition of scar contracture, better maintenance of ear projection and higher patient satisfaction than conventional ear splints following ear elevation surgery in microtia patients. Therefore, 3D-printed ear splints should be preferred over conventional ear splints whenever possible.",2020,"At 4 weeks postoperatively, the VSS score (p = 0.748) and cranioauricular distance (p = 0.647) showed no significant differences between the groups.","['microtia patients', 'Twenty patients were included in each group', 'Patients who underwent ear elevation surgery with postauricular fascia coverage between October 2017 and October 2018 were included']","['Splint therapy', '3D-printed ear splint', 'three-dimensional printed ear splint therapy', 'conventional thermoplastic ear splint', 'conventional ear splints', 'control group (thermoplastic ear splint) and underwent routine postoperative rehabilitation and antiscar therapy']","['mean cranioauricular distances', 'mean VSS scores', 'skin irritation or skin ulcers', 'Vancouver scar scale score (VSS score), cranioauricular distance, patient compliance, complications (dermatitis, skin ulcers, skin necrosis), and patient satisfaction', 'VSS score', 'cranioauricular distance', 'patient satisfaction scores']","[{'cui': 'C0152423', 'cui_str': 'Microtia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0013443', 'cui_str': 'Ear structure'}, {'cui': 'C0439775', 'cui_str': 'Elevation'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0442168', 'cui_str': 'Postauricular'}, {'cui': 'C0015641', 'cui_str': 'Fascial'}]","[{'cui': 'C0038009', 'cui_str': 'Splint'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0033161', 'cui_str': 'Printing'}, {'cui': 'C0013443', 'cui_str': 'Ear structure'}, {'cui': 'C0450363', 'cui_str': 'Three-dimensional'}, {'cui': 'C0439858', 'cui_str': 'Conventional'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205547', 'cui_str': 'Routine'}, {'cui': 'C0877071', 'cui_str': 'Postoperative rehabilitation'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0012751', 'cui_str': 'Distance'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0152030', 'cui_str': 'Skin irritation'}, {'cui': 'C0037299', 'cui_str': 'Skin ulcer'}, {'cui': 'C0008767', 'cui_str': 'Scarring'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1321605', 'cui_str': 'Compliance behavior'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0011603', 'cui_str': 'Dermatitis'}, {'cui': 'C0151799', 'cui_str': 'Skin necrosis'}, {'cui': 'C0030702', 'cui_str': 'Client satisfaction'}, {'cui': 'C0451370', 'cui_str': 'Patient satisfaction score'}]",20.0,0.0512882,"At 4 weeks postoperatively, the VSS score (p = 0.748) and cranioauricular distance (p = 0.647) showed no significant differences between the groups.","[{'ForeName': 'Jia', 'Initials': 'J', 'LastName': 'Xu', 'Affiliation': ""Department of Plastic and Reconstructive Surgery, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, People's Republic of China.""}, {'ForeName': 'Zin Mar', 'Initials': 'ZM', 'LastName': 'Aung', 'Affiliation': ""Department of Plastic and Reconstructive Surgery, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, People's Republic of China.""}, {'ForeName': 'Sousan', 'Initials': 'S', 'LastName': 'Cheong', 'Affiliation': ""Department of Plastic and Reconstructive Surgery, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, People's Republic of China.""}, {'ForeName': 'Taeho', 'Initials': 'T', 'LastName': 'Won', 'Affiliation': ""Department of Plastic and Reconstructive Surgery, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, People's Republic of China.""}, {'ForeName': 'Ruhong', 'Initials': 'R', 'LastName': 'Zhang', 'Affiliation': ""Department of Plastic and Reconstructive Surgery, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, People's Republic of China.""}, {'ForeName': 'Feng', 'Initials': 'F', 'LastName': 'Xu', 'Affiliation': ""Department of Plastic and Reconstructive Surgery, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, People's Republic of China.""}, {'ForeName': 'Jiajun', 'Initials': 'J', 'LastName': 'Fan', 'Affiliation': ""Department of Plastic and Reconstructive Surgery, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, People's Republic of China. Electronic address: fanjj3177@sh9hospital.org.""}, {'ForeName': 'Dong', 'Initials': 'D', 'LastName': 'Han', 'Affiliation': ""Department of Plastic and Reconstructive Surgery, Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine, People's Republic of China. Electronic address: handong12000@163.com.""}]",Journal of cranio-maxillo-facial surgery : official publication of the European Association for Cranio-Maxillo-Facial Surgery,['10.1016/j.jcms.2020.06.003'] 2963,32620379,A randomized trial of the immediate effect of bee-humming breathing exercise on blood pressure and heart rate variability in patients with essential hypertension.,"OBJECTIVES Bee-Humming Breathing (BHB) exercise is a simple yogic practice recommended for its favorable effect on cardiac physiology, including blood pressure (BP) and autonomic nervous system. However, strong evidence supporting its effectiveness is lacking. The present study was designed to evaluate the immediate effect of BHB exercise on blood pressure parameters and heart rate variability (HRV) in patients with essential hypertension. STUDY METHODS We conducted a randomized control trial including 70 patients with essential hypertension, randomly allocated to perform either BHB exercise (n=35) or placebo slow breathing exercise (n = 35) for 5-minutes duration. Blood pressure and HRV were measured before, during, and after the practice. RESULTS There was no significant decrease in systolic [effect size (95% CI): 2.22 (-13.20, 17.64); p 0.77], diastolic [4.54 (-17.40, 26.48); p 0.68] and mean blood pressures [1.37 (-8.78, 11.52); p 0.78] after BHB exercise in comparison to the control group in our study. The HRV analysis showed a significant increase in the HF power [6.8 (1.47, 12.12); p 0.01], and decrease in the LF power [-26.47 (-34.25, -18.68); p < 0.01] during the recovery phase of the 5-minute BHB exercise in comparison to the control group. CONCLUSIONS This is the first randomized controlled trial to show that though a single short session of BHB exercise in hypertensive patients does not significantly reduce BP, it significantly augments the parasympathetic tone as indicated by a significant improvement in HRV parameters. CLINICAL TRIAL REGISTRATION NUMBER CTRI/2018/08/015215.",2020,"The HRV analysis showed a significant increase in the HF power [6.8 (1.47, 12.12); p 0.01], and decrease in the LF power [-26.47 (-34.25, -18.68); p < 0.01] during the recovery phase of the 5-minute BHB exercise in comparison to the control group. ","['hypertensive patients', 'patients with essential hypertension', '70 patients with essential hypertension']","['bee-humming breathing exercise', 'BHB exercise', 'placebo slow breathing exercise', 'Bee-Humming Breathing (BHB) exercise']","['mean blood pressures', 'HF power', 'LF power', 'blood pressure parameters and heart rate variability (HRV', 'Blood pressure and HRV', 'parasympathetic tone', 'systolic [effect size', 'blood pressure (BP) and autonomic nervous system', 'blood pressure and heart rate variability']","[{'cui': 'C0857121', 'cui_str': 'Hypertensive'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0085580', 'cui_str': 'Essential hypertension'}]","[{'cui': 'C0004923', 'cui_str': 'Bee'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0231837', 'cui_str': 'Slow respiration'}]","[{'cui': 'C0428886', 'cui_str': 'Mean blood pressure'}, {'cui': 'C0005823', 'cui_str': 'Blood pressure'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C1280500', 'cui_str': 'Effect'}, {'cui': 'C0456389', 'cui_str': 'Size'}, {'cui': 'C0004388', 'cui_str': 'Autonomic nervous system structure'}]",70.0,0.126221,"The HRV analysis showed a significant increase in the HF power [6.8 (1.47, 12.12); p 0.01], and decrease in the LF power [-26.47 (-34.25, -18.68); p < 0.01] during the recovery phase of the 5-minute BHB exercise in comparison to the control group. ","[{'ForeName': 'Nirmal', 'Initials': 'N', 'LastName': 'Ghati', 'Affiliation': 'Department of Cardiology, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Avantika K', 'Initials': 'AK', 'LastName': 'Killa', 'Affiliation': 'Center for Integrative Medicine and Research (CIMR), All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Gautam', 'Initials': 'G', 'LastName': 'Sharma', 'Affiliation': 'Center for Integrative Medicine and Research (CIMR); Professor, Department of Cardiology, All India Institute of Medical Sciences, New Delhi, 110029, India. Electronic address: drsharmagautam@aiims.edu.'}, {'ForeName': 'Biju', 'Initials': 'B', 'LastName': 'Karunakaran', 'Affiliation': 'Center for Integrative Medicine and Research (CIMR), All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Aman', 'Initials': 'A', 'LastName': 'Agarwal', 'Affiliation': 'Center for Integrative Medicine and Research (CIMR), All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Sriloy', 'Initials': 'S', 'LastName': 'Mohanty', 'Affiliation': 'Center for Integrative Medicine and Research (CIMR), All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Nivethitha', 'Affiliation': 'Center for Integrative Medicine and Research (CIMR), All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'Deepti', 'Initials': 'D', 'LastName': 'Siddharthan', 'Affiliation': 'Department of Cardiology, All India Institute of Medical Sciences, New Delhi, India.'}, {'ForeName': 'R M', 'Initials': 'RM', 'LastName': 'Pandey', 'Affiliation': 'Department of Biostatistics, All India Institute of Medical Sciences, New Delhi, India.'}]","Explore (New York, N.Y.)",['10.1016/j.explore.2020.03.009'] 2964,32620536,Long-term efficacy of olipudase alfa in adults with acid sphingomyelinase deficiency (ASMD): Further clearance of hepatic sphingomyelin is associated with additional improvements in pro- and anti-atherogenic lipid profiles after 42 months of treatment.,"The liver is a major site of lipoprotein synthesis and metabolism. Liver manifestations of chronic visceral ASMD include hepatomegaly, fibrosis, elevated liver enzymes and a pro-atherogenic lipid profile. Measurements of sphingomyelin (SM) levels in liver biopsies and lyso-SM in plasma were used as pharmacodynamic biomarkers. Five adult patients with chronic visceral ASMD were enrolled in a 26-week phase 1b trial of enzyme replacement therapy (ERT) with olipudase alfa (NCT01722526) followed by an ongoing long-term extension study (NCT02004704). We compare the changes in hepatic SM levels, plasma lyso-SM, and lipoprotein profiles after 42 months of treatment. Progressive clearance of histologic SM storage was observed throughout the trial, along with similar reductions in plasma lyso-SM. Improvements in liver enzymes were observed at 6 months and remained stable at 42 months. Progressive reductions from baseline in pro-atherogenic lipid profiles (total cholesterol, LDL-C, VLDL-C, triglycerides) were observed at month 6 and 42. Conversely, there were progressive increases in anti-atherogenic markers, HDL-C and apolipoprotein A-I, with HDL-C increases up to 200% over baseline levels after 42 months of treatment. These data demonstrate that hepatic clearance of SM during olipudase alfa treatment over 42 months is associated with overall improvements in the lipid profiles of ASMD patients. The clinical relevance of these findings needs to be determined in the future, but we speculate that these improvements may reduce the risk for liver cirrhosis and cardiovascular disease. Trial registration: Clintrials.gov trial registration # NCT01722526.",2020,"Progressive reductions from baseline in pro-atherogenic lipid profiles (total cholesterol, LDL-C, VLDL-C, triglycerides) were observed at month 6 and 42.","['Five adult patients with chronic visceral ASMD', 'adults with acid sphingomyelinase deficiency (ASMD']","['olipudase alfa', 'enzyme replacement therapy (ERT) with olipudase alfa']","['Progressive clearance of histologic SM storage', 'plasma lyso-SM', 'pro-atherogenic lipid profiles (total cholesterol, LDL-C, VLDL-C, triglycerides', 'hepatic SM levels, plasma lyso-SM, and lipoprotein profiles', 'Measurements of sphingomyelin (SM) levels', 'anti-atherogenic markers, HDL-C and apolipoprotein A', 'liver enzymes', 'pro- and anti-atherogenic lipid profiles', 'hepatic clearance of SM']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0442045', 'cui_str': 'Visceral'}, {'cui': 'C1862839', 'cui_str': 'Irido-corneal dysgenesis'}, {'cui': 'C0037903', 'cui_str': 'Sphingomyelin phosphodiesterase'}, {'cui': 'C0011155', 'cui_str': 'Deficiency'}]","[{'cui': 'C4278198', 'cui_str': 'olipudase alfa'}, {'cui': 'C0598391', 'cui_str': 'Enzyme Replacement Therapy'}]","[{'cui': 'C0205329', 'cui_str': 'Progressive'}, {'cui': 'C0449297', 'cui_str': 'Clearance'}, {'cui': 'C0205462', 'cui_str': 'Histologic'}, {'cui': 'C0037906', 'cui_str': 'Sphingomyelin'}, {'cui': 'C1698986', 'cui_str': 'Storage'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0033382', 'cui_str': 'Proline'}, {'cui': 'C0023779', 'cui_str': 'Lipid'}, {'cui': 'C0201950', 'cui_str': 'Cholesterol measurement'}, {'cui': 'C0023169', 'cui_str': 'LDL(1)'}, {'cui': 'C0023825', 'cui_str': 'Very low density lipoprotein'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0205054', 'cui_str': 'Portal'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0023820', 'cui_str': 'Lipoprotein'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0023821', 'cui_str': 'High density lipoprotein'}, {'cui': 'C0003592', 'cui_str': 'Apolipoprotein A'}, {'cui': 'C0443764', 'cui_str': 'Liver enzyme'}]",5.0,0.0493624,"Progressive reductions from baseline in pro-atherogenic lipid profiles (total cholesterol, LDL-C, VLDL-C, triglycerides) were observed at month 6 and 42.","[{'ForeName': 'Beth L', 'Initials': 'BL', 'LastName': 'Thurberg', 'Affiliation': 'Department of Pathology, Sanofi Genzyme, Cambridge, MA, United States of America. Electronic address: Beth.Thurberg@sanofi.com.'}, {'ForeName': 'George A', 'Initials': 'GA', 'LastName': 'Diaz', 'Affiliation': 'Genetics and Genomics Sciences, Icahn School of Medicine at Mount Sinai, New York, NY, United States of America.'}, {'ForeName': 'Robin H', 'Initials': 'RH', 'LastName': 'Lachmann', 'Affiliation': 'National Hospital for Neurology and Neurosurgery, London, UK.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Schiano', 'Affiliation': 'Genetics and Genomics Sciences, Icahn School of Medicine at Mount Sinai, New York, NY, United States of America.'}, {'ForeName': 'Melissa P', 'Initials': 'MP', 'LastName': 'Wasserstein', 'Affiliation': ""Children's Hospital at Montefiore, Albert Einstein College of Medicine, Bronx, NY, United States of America.""}, {'ForeName': 'Allena J', 'Initials': 'AJ', 'LastName': 'Ji', 'Affiliation': 'Biomarkers and Clinical Bioanalysis, Sanofi Genzyme, Framingham, MA, United States of America.'}, {'ForeName': 'Atef', 'Initials': 'A', 'LastName': 'Zaher', 'Affiliation': 'Clinical Development, Sanofi Genzyme, Cambridge, MA, United States of America.'}, {'ForeName': 'M Judith', 'Initials': 'MJ', 'LastName': 'Peterschmitt', 'Affiliation': 'Clinical Development, Sanofi Genzyme, Cambridge, MA, United States of America.'}]",Molecular genetics and metabolism,['10.1016/j.ymgme.2020.06.010'] 2965,32620543,"I-FiBH trial: intravenous fluids in benign headaches-a randomised, single-blinded clinical trial.","BACKGROUND Many emergency physicians use an intravenous fluid bolus as part of a 'cocktail' of therapies for patients with headache, but it is unclear if this is beneficial. The objective of this study was to determine if an intravenous fluid bolus helps reduce pain or improve other outcomes in patients who present to the ED with a benign headache. METHODS This was a randomised, single-blinded, clinical trial performed on patients aged 10-65 years old with benign headaches who presented to a single ED in Las Vegas, Nevada, from May 2017 to February 2019. All patients received prochlorperazine and diphenhydramine, and they were randomised to also receive either 20 mL/kg up to 1000 mL of normal saline (the fluid bolus group) or 5 mL of normal saline (the control group). The primary outcome was the difference between groups in mean pain reduction 60 min after the initiation of treatment. Secondarily, we compared groups with regards to pain reduction at 30 min, nausea scores, the use of rescue medications and disposition. RESULTS We screened 67 patients for enrolment, and 58 consented. Of those, 35 were randomised to the fluid bolus group and 23 to the control group. The mean pain score dropped by 48.3 mm over 60 min in the fluid bolus group, compared with 48.7 mm in the control group. The between groups difference of 0.4 mm (95% CI -16.5 to 17.3) was not statistically significant (p=0.96). Additionally, no statistically significant difference was found between groups for any secondary outcome. CONCLUSION Though our study lacked statistical power to detect small but clinically significant differences, ED patients who received an intravenous fluid bolus for their headache had similar improvements in pain and other outcomes compared with those who did not. TRIAL REGISTRATION NUMBER NCT03185130.",2020,"The mean pain score dropped by 48.3 mm over 60 min in the fluid bolus group, compared with 48.7 mm in the control group.","['patients with headache', 'patients aged 10-65 years old with benign headaches who presented to a single ED in Las Vegas, Nevada, from May 2017 to February 2019', '67 patients for enrolment, and 58 consented', 'patients who present to the ED with a benign headache']","['20\u2009mL/kg up to 1000\u2009mL of normal saline (the fluid bolus group) or 5\u2009mL of normal saline', 'prochlorperazine and diphenhydramine']","['pain reduction at 30\u2009min, nausea scores, the use of rescue medications and disposition', 'mean pain reduction', 'mean pain score', 'pain']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0018681', 'cui_str': 'Headache'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0580836', 'cui_str': 'Old'}, {'cui': 'C0205183', 'cui_str': 'Benign'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0027951', 'cui_str': 'Nevada'}, {'cui': 'C2711213', 'cui_str': 'Consented'}]","[{'cui': 'C1300574', 'cui_str': 'mL/kg'}, {'cui': 'C0547043', 'cui_str': 'Up'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0005889', 'cui_str': 'Body fluid'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0033229', 'cui_str': 'Prochlorperazine'}, {'cui': 'C0012522', 'cui_str': 'Diphenhydramine'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0456693', 'cui_str': '/30 min'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C1524063', 'cui_str': 'Use of'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0184758', 'cui_str': 'Patient disposition'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}]",67.0,0.547929,"The mean pain score dropped by 48.3 mm over 60 min in the fluid bolus group, compared with 48.7 mm in the control group.","[{'ForeName': 'Tony', 'Initials': 'T', 'LastName': 'Zitek', 'Affiliation': 'Department of Emergency Medicine, Kendall Regional Medical Center, Miami, Florida, USA zitek10@gmail.com.'}, {'ForeName': 'Tiffany', 'Initials': 'T', 'LastName': 'Sigal', 'Affiliation': ""Department of Emergency Medicine, Mike O'Callaghan Federal Medical Center, Nellis Afb, Nevada, USA.""}, {'ForeName': 'Gina', 'Initials': 'G', 'LastName': 'Sun', 'Affiliation': 'Department of Emergency Medicine, University of Nevada, Las Vegas School of Medicine, Las Vegas, Nevada, USA.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Martin Manuel', 'Affiliation': 'Department of Emergency Medicine, University Medical Center of Southern Nevada, Las Vegas, Nevada, USA.'}, {'ForeName': 'Khanhha', 'Initials': 'K', 'LastName': 'Tran', 'Affiliation': 'Department of Emergency Medicine, University Medical Center of Southern Nevada, Las Vegas, Nevada, USA.'}]",Emergency medicine journal : EMJ,['10.1136/emermed-2019-209389'] 2966,31803473,Seasonal variability of lung function and Asthma Quality of Life Questionnaire Scores in adults with uncontrolled asthma.,"Introduction Asthma exacerbations spike in the spring and autumn months, yet the seasonal variation of asthma symptoms and lung function is poorly studied. Methods Seasonal variation of lung function, rescue medication use and patient-reported symptoms was evaluated by post hoc analyses of the Phase III lebrikizumab (anti-IL-13) LAVOLTA I and II studies in 2148 subjects with uncontrolled asthma. Lung function measurements (prebronchodilator FEV 1 , forced vital capacity (FVC) and peak expiratory flow (PEF)), rescue medication use and Standardised Asthma Quality of Life Questionnaire (AQLQ(S)) were measured every 4 weeks over 52 weeks. By-month estimates normalised by hemispheric season were based on mixed-effect models with repeated measures (MMRM), adjusted by study stratification factors as covariates when appropriate. The dependency of clinical outcomes with seasonal variability was assessed by employing linear contrasts comparing hemisphere normalised December versus July group means from an MMRM regression and presented as the difference in means (adjusted 95% CI). Results FEV 1 , FVC and PEF, rescue medication use and AQLQ(S) progressively worsened towards winter, unlike spring and autumn surges in asthma exacerbations. The December versus July mean differences were: (1) PEF=-6.5 (-8.7 to -4.2) L/min, 2) prebronchodilator FEV 1 =-42 (-57 to -27) mL, (3) FVC=-41 (-59 to -23) mL and (4) AQLQ(S)=-0.15 (-0.19 to -0.1) units. Among AQLQ questions, discomfort or distress related to cough was most variable with respect to season (-0.33 (-0.42 to -0.24) units). Discussion Interpretation of interventional studies biased by seasonal exposures may be confounded by seasonal variability. Trials registration numbers NCT01867125 and NCT01868061.",2019,"Results FEV 1 , FVC and PEF, rescue medication use and AQLQ(S) progressively worsened towards winter, unlike spring and autumn surges in asthma exacerbations.","['2148 subjects with uncontrolled asthma', 'adults with uncontrolled asthma']",['prebronchodilator'],"['Seasonal variability of lung function and Asthma Quality of Life Questionnaire Scores', 'FEV 1 , FVC and PEF, rescue medication use and AQLQ(S', 'Lung function measurements (prebronchodilator FEV 1 , forced vital capacity (FVC) and peak expiratory flow (PEF)), rescue medication use and Standardised Asthma Quality of Life Questionnaire (AQLQ(S', 'AQLQ questions, discomfort or distress related to cough', 'lung function, rescue medication use and patient-reported symptoms']","[{'cui': 'C0205318', 'cui_str': 'Uncontrolled'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]",[],"[{'cui': 'C0439601', 'cui_str': 'Seasonal course'}, {'cui': 'C0024119', 'cui_str': 'Pulmonary function test'}, {'cui': 'C0004096', 'cui_str': 'Asthma'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C3714541', 'cui_str': 'Forced vital capacity'}, {'cui': 'C0030771', 'cui_str': 'Pefloxacin'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0430511', 'cui_str': 'Vital capacity test'}, {'cui': 'C0444505', 'cui_str': 'Peak'}, {'cui': 'C0231800', 'cui_str': 'Expiration'}, {'cui': 'C2364135', 'cui_str': 'Discomfort'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0010200', 'cui_str': 'Coughing'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",2148.0,0.036725,"Results FEV 1 , FVC and PEF, rescue medication use and AQLQ(S) progressively worsened towards winter, unlike spring and autumn surges in asthma exacerbations.","[{'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'N Bauer', 'Affiliation': 'Genentech, Inc, South San Francisco, California, USA.'}, {'ForeName': 'Xiaoying', 'Initials': 'X', 'LastName': 'Yang', 'Affiliation': 'Genentech, Inc, South San Francisco, California, USA.'}, {'ForeName': 'Tracy', 'Initials': 'T', 'LastName': 'L Staton', 'Affiliation': 'Genentech, Inc, South San Francisco, California, USA.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Olsson', 'Affiliation': 'Genentech, Inc, South San Francisco, California, USA.'}, {'ForeName': 'Cecile T J', 'Initials': 'CTJ', 'LastName': 'Holweg', 'Affiliation': 'Genentech, Inc, South San Francisco, California, USA.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'R Arron', 'Affiliation': 'Genentech, Inc, South San Francisco, California, USA.'}, {'ForeName': 'John G', 'Initials': 'JG', 'LastName': 'Matthews', 'Affiliation': 'Genentech, Inc, South San Francisco, California, USA.'}, {'ForeName': 'David F', 'Initials': 'DF', 'LastName': 'Choy', 'Affiliation': 'Genentech, Inc, South San Francisco, California, USA.'}]",BMJ open respiratory research,['10.1136/bmjresp-2019-000406'] 2967,31803478,'Reduced' HUNT model outperforms NLST and NELSON study criteria in predicting lung cancer in the Danish screening trial.,"Hypothesis We hypothesise that the validated HUNT Lung Cancer Risk Model would perform better than the NLST (USA) and the NELSON (Dutch-Belgian) criteria in the Danish Lung Cancer Screening Trial (DLCST). Methods The DLCST measured only five out of the seven variables included in validated HUNT Lung Cancer Model. Therefore a 'Reduced' model was retrained in the Norwegian HUNT2-cohort using the same statistical methodology as in the original HUNT model but based only on age, pack years, smoking intensity, quit time and body mass index (BMI), adjusted for sex. The model was applied on the DLCST-cohort and contrasted against the NLST and NELSON criteria. Results Among the 4051 smokers in the DLCST with 10 years follow-up, median age was 57.6, BMI 24.75, pack years 33.8, cigarettes per day 20 and most were current smokers. For the same number of individuals selected for screening, the performance of the 'Reduced' HUNT was increased in all metrics compared with both the NLST and the NELSON criteria. In addition, to achieve the same sensitivity, one would need to screen fewer people by the 'Reduced' HUNT model versus using either the NLST or the NELSON criteria (709 vs 918, p=1.02e-11 and 1317 vs 1668, p=2.2e-16, respectively). Conclusions The 'Reduced' HUNT model is superior in predicting lung cancer to both the NLST and NELSON criteria in a cost-effective way. This study supports the use of the HUNT Lung Cancer Model for selection based on risk ranking rather than age, pack year and quit time cut-off values. When we know how to rank personal risk, it will be up to the medical community and lawmakers to decide which risk threshold will be set for screening.",2019,"For the same number of individuals selected for screening, the performance of the 'Reduced' HUNT was increased in all metrics compared with both the NLST and the NELSON criteria.","['4051 smokers in the DLCST with 10 years follow-up, median age was 57.6, BMI 24.75, pack years 33.8, cigarettes per day 20 and most were current smokers']","['NLST', 'NLST (USA']",[],"[{'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0010969', 'cui_str': 'Danish language'}, {'cui': 'C0281477', 'cui_str': 'Screening for malignant neoplasm of lung'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1277691', 'cui_str': 'Pack years'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0439505', 'cui_str': '/day'}, {'cui': 'C0521116', 'cui_str': 'Current'}]","[{'cui': 'C0041703', 'cui_str': 'United States of America'}]",[],,0.0163465,"For the same number of individuals selected for screening, the performance of the 'Reduced' HUNT was increased in all metrics compared with both the NLST and the NELSON criteria.","[{'ForeName': 'Oluf Dimitri', 'Initials': 'OD', 'LastName': 'Røe', 'Affiliation': 'Department of Clinical and Molecular Medicine, Norges teknisk-naturvitenskapelige universitet, Trondheim, Norway.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Markaki', 'Affiliation': 'Department of Computer Science, University of Crete - Voutes Campus, Heraklion, Greece.'}, {'ForeName': 'Ioannis', 'Initials': 'I', 'LastName': 'Tsamardinos', 'Affiliation': 'Department of Computer Science, University of Crete - Voutes Campus, Heraklion, Greece.'}, {'ForeName': 'Vincenzo', 'Initials': 'V', 'LastName': 'Lagani', 'Affiliation': 'Science and Technology Park of Crete, GNOSIS Data Analysis PC, Heraklion, Greece.'}, {'ForeName': 'Olav Toai Duc', 'Initials': 'OTD', 'LastName': 'Nguyen', 'Affiliation': 'Department of Clinical and Molecular Medicine, Norges teknisk-naturvitenskapelige universitet, Trondheim, Norway.'}, {'ForeName': 'Jesper Holst', 'Initials': 'JH', 'LastName': 'Pedersen', 'Affiliation': 'Department of Thoracic Surgery RT, Rigshospitalet, University of Copenhagen, Faculty of Health Sciences, Copenhagen, Denmark.'}, {'ForeName': 'Zaigham', 'Initials': 'Z', 'LastName': 'Saghir', 'Affiliation': 'Department of Respiratory Medicine, Gentofte University Hospital, Hellerup, Denmark.'}, {'ForeName': 'Haseem Gary', 'Initials': 'HG', 'LastName': 'Ashraf', 'Affiliation': 'Department of Respiratory Medicine, Gentofte University Hospital, Hellerup, Denmark.'}]",BMJ open respiratory research,['10.1136/bmjresp-2019-000512'] 2968,32621047,A time to revisit the two oldest prandial anti-diabetes agents: acarbose and repaglinide.,"PURPOSE Compared with newer prandial anti-diabetes agents, repaglinide and acarbose are unique in being globally available in generic versions, being oral, and being the cheapest of all. The aim of this study was to compare their efficacy when used alone or in combination. METHODS In a randomized, double-blind, prospective study, 358 recently diagnosed type 2 diabetes (T2D) patients, who on a combined therapy with metformin and insulin glargine had a fasting plasma glucose (FGP) of <7.2 mmol/L but a 2-h postprandial plasma glucose (2hPPG) >10 mmol/L, were assigned to three groups of additional treatment with either repaglinide, acarbose, or repaglinide-plus-acarbose for 4 months. RESULTS With intention-to-treat analysis, 63% of repaglinide group, 45.4 percent of acarbose group, and 75.7% of repaglinide-plus-acarbose group reached the primary endpoint of 2hPPG < 10 mmol/L while maintaining FPG < 7.2 mmol/L. Treatment adherence rate was 75.6% with repaglinide, 61.4% with acarbose, and 81.3% with repaglinide-plus-acarbose (p = 0.001). Among the groups, weight was significantly lower in acarbose group (p < 0.05). Twenty-one percent of repaglinide patients, 4.9% of acarbose subjects, and 10.3% of repaglinide-plus-acarbose cases reported at least one episode of hypoglycemia (p < 0.005). HbA1C and basal insulin requirement were significantly lower in repaglinide group (p = 0.004, p = 0.0002). Triglycerides were lowest in acarbose group (p = 0.005). CONCLUSIONS Both acarbose and repaglinide were vastly effective in lowering postprandial hyperglycemia of recently diagnosed T2D. When combined, they were even more efficacious and the disease had a better outcome. Compared with newer peers, these two are particularly useful where and when cost consideration in diabetes treatment is a prime concern.",2020,Both acarbose and repaglinide were vastly effective in lowering postprandial hyperglycemia of recently diagnosed T2D.,"['had a fasting plasma glucose (FGP) of <7.2\u2009mmol/L but a 2-h postprandial plasma glucose (2hPPG', '358 recently diagnosed type 2 diabetes (T2D) patients, who on a combined therapy with']","['repaglinide-plus-acarbose', 'acarbose and repaglinide', 'repaglinide', 'acarbose', 'prandial anti-diabetes agents, repaglinide and acarbose', 'metformin and insulin glargine', 'repaglinide, acarbose, or repaglinide-plus-acarbose']","['weight', 'HbA1C and basal insulin requirement', 'adherence rate', 'postprandial hyperglycemia', 'Triglycerides', 'episode of hypoglycemia']","[{'cui': 'C0583513', 'cui_str': 'Plasma fasting glucose measurement'}, {'cui': 'C4517857', 'cui_str': '7.2'}, {'cui': 'C1532563', 'cui_str': 'mmol/L'}, {'cui': 'C0011744', 'cui_str': 'Deuterium'}, {'cui': 'C0376674', 'cui_str': 'Postprandial'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0033972', 'cui_str': 'Combined therapy'}]","[{'cui': 'C0246689', 'cui_str': 'repaglinide'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0050393', 'cui_str': 'Acarbose'}, {'cui': 'C0450442', 'cui_str': 'Agent'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}]","[{'cui': 'C0005910', 'cui_str': 'Body weight'}, {'cui': 'C0019018', 'cui_str': 'Hemoglobin A, Glycosylated'}, {'cui': 'C0205112', 'cui_str': 'Basal'}, {'cui': 'C0021641', 'cui_str': 'Insulin'}, {'cui': 'C2364055', 'cui_str': 'Compliant behavior'}, {'cui': 'C1855520', 'cui_str': 'Postprandial Hyperglycemia'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0332189', 'cui_str': 'Episode of'}, {'cui': 'C0020615', 'cui_str': 'Hypoglycemia'}]",358.0,0.0419812,Both acarbose and repaglinide were vastly effective in lowering postprandial hyperglycemia of recently diagnosed T2D.,"[{'ForeName': 'Parisa', 'Initials': 'P', 'LastName': 'Pishdad', 'Affiliation': 'Shiraz Medical School, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Reza', 'Initials': 'R', 'LastName': 'Pishdad', 'Affiliation': 'Department of Internal Medicine, Rutgers New Jersey Medical School, Newark, NJ, USA.'}, {'ForeName': 'Gholam Reza', 'Initials': 'GR', 'LastName': 'Pishdad', 'Affiliation': 'Endocrine and Metabolism Research Center, Shiraz University of Medical Sciences, Shiraz, Iran. pishdadg@sums.ac.ir.'}, {'ForeName': 'Yunes', 'Initials': 'Y', 'LastName': 'Panahi', 'Affiliation': ""Chemical Injuries Research Center, Tehran's Baqiyatallah University of Medical Sciences, Tehran, Iran.""}]",Endocrine,['10.1007/s12020-020-02396-0'] 2969,32621071,"Pharmacokinetics, Safety, and Tolerability of a 2-Month Dose Interval Regimen of the Long-Acting Injectable Antipsychotic Aripiprazole Lauroxil: Results From a 44-Week Phase I Study.","BACKGROUND Aripiprazole lauroxil (AL) is a long-acting injectable antipsychotic approved for treatment of schizophrenia in adults. Approved AL doses and dosing regimens include 441 mg monthly, 662 mg monthly, and 882 mg monthly or every 6 weeks (q6wk), as well as the most recently approved dose, 1064 mg, administered every 2 months. OBJECTIVE Pharmacokinetics, safety, and tolerability of an AL regimen with a dose interval of every 2 months (1064 mg) were compared with two other regimens available as monthly and q6wk options. METHODS This study evaluated pharmacokinetics of AL given at a higher dosage strength (1064 mg) and at a longer dose interval (every 8 weeks [q8wk]) than previously studied. Patients with schizophrenia or schizoaffective disorder entering this 44-week, phase I, open-label, multicenter study had no recent exposure to aripiprazole and were maintained on other oral antipsychotics throughout the study. Patients were randomized to one of three AL dose regimens for 24 weeks (four 1064-mg injections [q8wk], five 882-mg injections [q6wk], or seven 441-mg injections [q4wk], with the last AL exposure at week 24). Oral aripiprazole was prohibited. Patients were followed for an additional 20 weeks to assess terminal aripiprazole plasma concentrations and ongoing safety. Plasma concentration samples were obtained at regular intervals to provide pharmacokinetic data for the duration of AL exposure and to measure persistence of plasma aripiprazole concentrations after AL discontinuation. RESULTS Eligible patients received AL 1064 mg q8wk (n = 35), 882 mg q6wk (n = 34), or 441 mg q4wk (n = 35). Overall, 103/104 (99.0%) patients were taking concomitant non-aripiprazole oral antipsychotic medications during the study. All three AL dose regimens provided continuous exposure to aripiprazole. Mean aripiprazole concentrations from the 1064-mg q8wk regimen were comparable to the 882-mg q6wk regimen and higher than the 441-mg q4wk regimen. Overall incidence by group of any adverse events (AEs) throughout the study was 68.6% (1064 mg q8wk), 50.0% (882 mg q6wk), and 65.7% (441 mg q4wk). The most common AE across regimens was injection-site pain (range 8.6%-11.4%). Serious AEs were reported by eight patients (all but one [increased psychosis in one patient, 441-mg q4wk group] considered unrelated to study drug). Discontinuations due to AEs were reported for 2.9%, 11.8%, and 5.7% of patients receiving the 8-, 6-, and 4-week regimens, respectively. AEs of akathisia, dyskinesia, and dystonia occurred in 2.9%, 8.6%, and 5.7% of patients in the 1064-mg q8wk group, 8.8%, 0%, and 2.9% in the 882-mg q6wk group, and 8.6%, 0%, and 0% in the 441-mg q4wk group, respectively. CONCLUSIONS AL 1064 mg q8wk provided continuous exposure to aripiprazole throughout the 8-week dosing interval and had a safety profile consistent with the 4- and 6-week regimens. These findings were used to support FDA approval of the 1064-mg dose administered every 2 months. REGISTRATION Clinicaltrials.gov: NCT02320032.",2020,"Overall incidence by group of any adverse events (AEs) throughout the study was 68.6% (1064 mg q8wk), 50.0% (882 mg q6wk), and 65.7% (441 mg q4wk).","['schizophrenia in adults', 'Patients with schizophrenia or schizoaffective disorder entering this 44-week, phase I, open-label, multicenter study had no recent exposure to']","['Aripiprazole lauroxil (AL', 'Long-Acting Injectable Antipsychotic Aripiprazole Lauroxil', 'Oral aripiprazole', 'aripiprazole']","['Pharmacokinetics, Safety, and Tolerability', 'terminal aripiprazole plasma concentrations and ongoing safety', 'akathisia, dyskinesia, and dystonia', 'Plasma concentration samples', 'plasma aripiprazole concentrations', 'Mean aripiprazole concentrations', 'Pharmacokinetics, safety, and tolerability']","[{'cui': 'C0036341', 'cui_str': 'Schizophrenia'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0036337', 'cui_str': 'Schizoaffective disorder'}, {'cui': 'C1522196', 'cui_str': 'Enteral route'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0175566', 'cui_str': 'Open'}, {'cui': 'C1096776', 'cui_str': 'Multicenter Studies'}, {'cui': 'C0332185', 'cui_str': 'Recent'}, {'cui': 'C0332157', 'cui_str': 'Exposure to'}]","[{'cui': 'C4056439', 'cui_str': 'aripiprazole lauroxil'}, {'cui': 'C0205166', 'cui_str': 'Long'}, {'cui': 'C0079613', 'cui_str': 'Adoptive Immunotherapy'}, {'cui': 'C0086466', 'cui_str': 'Injectable Product'}, {'cui': 'C0040615', 'cui_str': 'Antipsychotic agent'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0299792', 'cui_str': 'aripiprazole'}]","[{'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205088', 'cui_str': 'End-stage'}, {'cui': 'C0299792', 'cui_str': 'aripiprazole'}, {'cui': 'C0032105', 'cui_str': 'blood plasma'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0549178', 'cui_str': 'Continuous'}, {'cui': 'C0392156', 'cui_str': 'Akathisia'}, {'cui': 'C0013384', 'cui_str': 'Dyskinesia'}, {'cui': 'C0013421', 'cui_str': 'Dystonia'}, {'cui': 'C0370003', 'cui_str': 'Specimen'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",,0.0184254,"Overall incidence by group of any adverse events (AEs) throughout the study was 68.6% (1064 mg q8wk), 50.0% (882 mg q6wk), and 65.7% (441 mg q4wk).","[{'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Weiden', 'Affiliation': 'Alkermes, Inc., Waltham, MA, USA. pjweiden@gmail.com.'}, {'ForeName': 'Yangchun', 'Initials': 'Y', 'LastName': 'Du', 'Affiliation': 'Alkermes, Inc., Waltham, MA, USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'von Moltke', 'Affiliation': 'Alkermes, Inc., Waltham, MA, USA.'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Wehr', 'Affiliation': 'Alkermes, Inc., Waltham, MA, USA.'}, {'ForeName': 'Marjie', 'Initials': 'M', 'LastName': 'Hard', 'Affiliation': 'Alkermes, Inc., Waltham, MA, USA.'}, {'ForeName': 'Morteza', 'Initials': 'M', 'LastName': 'Marandi', 'Affiliation': 'Radiant Clinical Research, Cerritos, CA, USA.'}, {'ForeName': 'David P', 'Initials': 'DP', 'LastName': 'Walling', 'Affiliation': 'CNS Network, LLC, Garden Grove, CA, USA.'}]",CNS drugs,['10.1007/s40263-020-00745-1'] 2970,32621073,"Conscious perception and the modulatory role of dopamine: no effect of the dopamine D2 agonist cabergoline on visual masking, the attentional blink, and probabilistic discrimination.","RATIONALE Conscious perception is thought to depend on global amplification of sensory input. In recent years, striatal dopamine has been proposed to be involved in gating information and conscious access, due to its modulatory influence on thalamocortical connectivity. OBJECTIVES Since much of the evidence that implicates striatal dopamine is correlational, we conducted a double-blind crossover pharmacological study in which we administered cabergoline-a dopamine D2 agonist-and placebo to 30 healthy participants. Under both conditions, we subjected participants to several well-established experimental conscious-perception paradigms, such as backward masking and the attentional blink task. RESULTS We found no evidence in support of an effect of cabergoline on conscious perception: key behavioral and event-related potential (ERP) findings associated with each of these tasks were unaffected by cabergoline. CONCLUSIONS Our results cast doubt on a causal role for dopamine in visual perception. It remains an open possibility that dopamine has causal effects in other tasks, perhaps where perceptual uncertainty is more prominent.",2020,"We found no evidence in support of an effect of cabergoline on conscious perception: key behavioral and event-related potential (ERP) findings associated with each of these tasks were unaffected by cabergoline. ",['30 healthy participants'],"['cabergoline-a dopamine D2 agonist-and placebo', 'dopamine D2 agonist cabergoline', 'backward masking and the attentional blink task', 'cabergoline', 'dopamine']","['visual masking, the attentional blink, and probabilistic discrimination']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0107994', 'cui_str': 'cabergoline'}, {'cui': 'C0013030', 'cui_str': 'Dopamine'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0439781', 'cui_str': 'Backward'}, {'cui': 'C1955945', 'cui_str': 'Attentional Blink'}]","[{'cui': 'C0234621', 'cui_str': 'Visual'}, {'cui': 'C1955945', 'cui_str': 'Attentional Blink'}, {'cui': 'C0012632', 'cui_str': 'Cognitive discrimination'}]",30.0,0.0541971,"We found no evidence in support of an effect of cabergoline on conscious perception: key behavioral and event-related potential (ERP) findings associated with each of these tasks were unaffected by cabergoline. ","[{'ForeName': 'E A', 'Initials': 'EA', 'LastName': 'Boonstra', 'Affiliation': 'Department of Experimental and Applied Psychology, Institute for Brain and Behavior Amsterdam (iBBA) Vrije Universiteit, Amsterdam, Netherlands. evertboonstra@gmail.com.'}, {'ForeName': 'M R', 'Initials': 'MR', 'LastName': 'van Schouwenburg', 'Affiliation': 'Department of Psychology, University of Amsterdam, Amsterdam Brain and Cognition (ABC), Amsterdam, Netherlands.'}, {'ForeName': 'A K', 'Initials': 'AK', 'LastName': 'Seth', 'Affiliation': 'Department of Informatics Sackler Centre for Consciousness Science, University of Sussex, Brighton, BN1 9QJ, UK.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Bauer', 'Affiliation': 'School of Psychology, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'J B', 'Initials': 'JB', 'LastName': 'Zantvoord', 'Affiliation': 'Department of Child and Adolescent Psychiatry, The Bascule, Academic Centre for Child and Adolescent Psychiatry Amsterdam University Medical Centers, Amsterdam, Netherlands.'}, {'ForeName': 'E M', 'Initials': 'EM', 'LastName': 'Kemper', 'Affiliation': 'Department of Pharmacy, Amsterdam University Medical Centers, Amsterdam, Netherlands.'}, {'ForeName': 'C S', 'Initials': 'CS', 'LastName': 'Lansink', 'Affiliation': 'Swammerdam Institute for Life Sciences, University of Amsterdam, Amsterdam Brain and Cognition (ABC), Amsterdam, Netherlands.'}, {'ForeName': 'H A', 'Initials': 'HA', 'LastName': 'Slagter', 'Affiliation': 'Department of Experimental and Applied Psychology, Institute for Brain and Behavior Amsterdam (iBBA) Vrije Universiteit, Amsterdam, Netherlands.'}]",Psychopharmacology,['10.1007/s00213-020-05579-9'] 2971,32621083,Evaluation of Characteristics of Gastrointestinal Adverse Events with Once-Weekly Dulaglutide Treatment in Chinese Patients with Type 2 Diabetes: A Post Hoc Pooled Analysis of Two Randomized Trials.,"INTRODUCTION Gastrointestinal (GI) events are a common side effect of glucagon-like peptide 1 (GLP-1) receptor agonists (RA) class. This post hoc analysis assessed the characteristics of GI adverse events in Chinese patients with type 2 diabetes (T2D) who were treated with once-weekly dulaglutide from two randomized clinical trials. METHODS Chinese patients with T2D, treated with once-weekly dulaglutide (1.5 mg and 0.75 mg) from two phase III multicenter trials (AWARD-CHN1 and AWARD-CHN2) were included. Descriptive statistics were used to present the data. The characteristics (incidence, severity, onset, duration, and time of occurrence) of GI adverse events reported through 26 weeks in a Chinese subpopulation from the two trials were investigated. RESULTS A total of 787 Chinese patients with T2D were included in this analysis. Up to week 26, 225 patients (28.6%) reported at least one GI treatment-emergent adverse event (TEAE). The most frequently reported GI TEAEs were diarrhea (13.1%), nausea (6.6%), abdominal distension (6.4%), and vomiting (3.0%), with most being categorized as mild to moderate in severity in proportions of 92%, 88%, 94%, and 83%, respectively. A total of 12 patients (1.5%) discontinued the dulaglutide treatment as a result of GI TEAEs. The median duration of the first reported GI TEAEs was 4.0, 5.0, 12.5, and 4.0 days for diarrhea, nausea, abdominal distension, and vomiting, respectively. The incidence of GI TEAEs was more frequent during the first 2 weeks of dulaglutide treatment; however, the incidence declined rapidly after 2 weeks and remained low until week 26. CONCLUSIONS Most of the GI TEAEs associated with once-weekly dulaglutide (1.5 mg and 0.75 mg) were mild to moderate in severity. The incidence of GI TEAEs was more pronounced during the first 2 weeks of dulaglutide treatment but declined rapidly as treatment continued, and was low at week 26, indicating that dulaglutide was well tolerated in Chinese patients with T2D. TRIAL REGISTRATION NCT01648582 and NCT01644500.",2020,"Up to week 26, 225 patients (28.6%) reported at least one GI treatment-emergent adverse event (TEAE).","['Chinese patients with T2D, treated with once-weekly dulaglutide (1.5\xa0mg and 0.75\xa0mg) from two phase\xa0III multicenter trials (AWARD-CHN1 and AWARD-CHN2) were included', 'Chinese patients with type\xa02 diabetes (T2D) who were treated with once-weekly dulaglutide from two randomized clinical trials', '787 Chinese patients with T2D', 'Chinese Patients with Type']",[],"['diarrhea', 'incidence of GI TEAEs', 'abdominal distension', 'median duration', 'characteristics (incidence, severity, onset, duration, and time of occurrence) of GI adverse events', 'vomiting', 'nausea', 'diarrhea, nausea, abdominal distension, and vomiting']","[{'cui': 'C0008120', 'cui_str': 'Chinese language'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0332293', 'cui_str': 'Treated with'}, {'cui': 'C0558293', 'cui_str': 'Once a week'}, {'cui': 'C3179549', 'cui_str': 'dulaglutide'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C4068882', 'cui_str': '0.75'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0206012', 'cui_str': 'Multicentre Trials'}, {'cui': 'C0004446', 'cui_str': 'Awards'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]",[],"[{'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0021149', 'cui_str': 'Incidence'}, {'cui': 'C0000731', 'cui_str': 'Swollen abdomen'}, {'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0206132', 'cui_str': 'Age-at-Onset'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0243132', 'cui_str': 'occurrence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0042963', 'cui_str': 'Vomiting'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}]",787.0,0.0832677,"Up to week 26, 225 patients (28.6%) reported at least one GI treatment-emergent adverse event (TEAE).","[{'ForeName': 'Lixin', 'Initials': 'L', 'LastName': 'Guo', 'Affiliation': 'Department of Endocrinology, Beijing Hospital, National Center of Gerontology, No.1, Dahua Road, Dongcheng District, Beijing, 100730, China.'}, {'ForeName': 'Bin', 'Initials': 'B', 'LastName': 'Zhang', 'Affiliation': 'Lilly Suzhou Pharmaceutical Co., Ltd, 19F, Tower 1 HKRI, Taikoo Hui, No. 288, Shi Men No. 1 Rd, Shanghai, 200041, China.'}, {'ForeName': 'Jianing', 'Initials': 'J', 'LastName': 'Hou', 'Affiliation': 'Lilly Suzhou Pharmaceutical Co., Ltd, 19F, Tower 1 HKRI, Taikoo Hui, No. 288, Shi Men No. 1 Rd, Shanghai, 200041, China. hou_jia_ning@lilly.com.'}, {'ForeName': 'Zhiguang', 'Initials': 'Z', 'LastName': 'Zhou', 'Affiliation': 'Department of Metabolism and Endocrinology, The Second Xiangya Hospital, Central South University, 139 Renmin Road, Changsha, 410011, Hunan, China. zhouzhiguang@csu.edu.cn.'}]","Diabetes therapy : research, treatment and education of diabetes and related disorders",['10.1007/s13300-020-00869-z'] 2972,32621102,The use of doxazosin before adrenalectomy for pheochromocytoma: is the duration related to intraoperative hemodynamics and postoperative complications?,"PURPOSE No conclusion exists for the optimum duration of preoperative administration of doxazosin (DOX) before adrenalectomy for pheochromocytoma. The purpose of this study is to investigate whether perioperative hemodynamics and postoperative outcomes are related to the duration of DOX administration. METHODS In total, 132 patients managed preoperatively with single α-receptor blocker DOX were enrolled. All patients underwent adrenalectomy for pheochromocytoma in the Department of Urology, Peking University First Hospital, between January 2001 and July 2019. Patients were divided into three groups based on the duration of preoperative administration of DOX: group A (≤14 days), group B (15-30 days), and group C (>30 days). Patient and tumor characteristics, intraoperative hemodynamics, and postoperative outcomes were recorded and compared. RESULTS These patients included 57 men and 75 women, with an average age of 48 years. Clinical characteristics, preoperative hemodynamics, medicine management and surgical approaches were comparable between the three groups. Among the three groups, we found that group C (>30 days) had the lowest intraoperative minimum heart rate [group A vs. group B vs. group C = 60 (52-67) vs. 59 (50-61) vs. 51.5 (50-58.75), p = 0.024] and highest risk of postoperative hypotension requiring vasopressor support [group A vs. group B vs. group C = 14 (20.3%) vs. 12 (27.9%) vs. 10 (50.0%), p = 0.032]. CONCLUSION The current study indicated that preoperative management of pheochromocytoma with single α-receptor blocker DOX for more than 30 days after final dose adjustment might lead to intraoperative bradycardia and more postoperative hypotension requiring vasopressor support. Thus, our study does not support long-term (over 30 days) preoperative administration of pheochromocytoma with single α-receptor blocker DOX in the final dose.",2020,"Clinical characteristics, preoperative hemodynamics, medicine management and surgical approaches were comparable between the three groups.","['patients included 57 men and 75 women, with an average age of 48\xa0years', '132 patients managed preoperatively with single α-receptor blocker DOX were enrolled', 'pheochromocytoma', 'All patients underwent adrenalectomy for pheochromocytoma in the Department of Urology, Peking University First Hospital, between January 2001 and July 2019']","['doxazosin (DOX', 'pheochromocytoma with single α-receptor blocker DOX', 'doxazosin', 'DOX']","['Patient and tumor characteristics, intraoperative hemodynamics, and postoperative outcomes', 'highest risk of postoperative hypotension requiring vasopressor support', 'lowest intraoperative minimum heart rate']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C1273870', 'cui_str': 'Management procedure'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}, {'cui': 'C0114873', 'cui_str': 'Doxazosin'}, {'cui': 'C0031511', 'cui_str': 'Chromaffinoma'}, {'cui': 'C0001632', 'cui_str': 'Adrenalectomy'}, {'cui': 'C0042077', 'cui_str': 'Urology'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0019994', 'cui_str': 'Hospitals'}]","[{'cui': 'C0114873', 'cui_str': 'Doxazosin'}, {'cui': 'C0031511', 'cui_str': 'Chromaffinoma'}, {'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0034783', 'cui_str': 'Adrenergic receptor'}]","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0456904', 'cui_str': 'Intraoperative'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0032790', 'cui_str': 'Postoperative period'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0332167', 'cui_str': 'High risk of'}, {'cui': 'C0865752', 'cui_str': 'Postoperative hypotension'}, {'cui': 'C0042397', 'cui_str': 'Vasoconstrictor agent'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0205251', 'cui_str': 'Low'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}]",132.0,0.0332186,"Clinical characteristics, preoperative hemodynamics, medicine management and surgical approaches were comparable between the three groups.","[{'ForeName': 'Hao', 'Initials': 'H', 'LastName': 'Kong', 'Affiliation': 'Department of Anaesthesiology and Critical Care Medicine, Peking University First Hospital, No. 8 Xishiku Street, Xicheng District, Beijing, 100034, China.'}, {'ForeName': 'Nan', 'Initials': 'N', 'LastName': 'Li', 'Affiliation': 'Department of Anaesthesiology and Critical Care Medicine, Peking University First Hospital, No. 8 Xishiku Street, Xicheng District, Beijing, 100034, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Tian', 'Affiliation': 'Department of Urology, Peking University First Hospital, No. 8 Xishiku Street, Xicheng District, Beijing, 100034, China.'}, {'ForeName': 'Zhengqing', 'Initials': 'Z', 'LastName': 'Bao', 'Affiliation': 'Department of Urology, Peking University First Hospital, No. 8 Xishiku Street, Xicheng District, Beijing, 100034, China.'}, {'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Liu', 'Affiliation': 'Department of Endocrinology, Peking University First Hospital, No. 8 Xishiku Street, Xicheng District, Beijing, 100034, China.'}, {'ForeName': 'Kai', 'Initials': 'K', 'LastName': 'Wu', 'Affiliation': 'Department of Endocrinology, Peking University First Hospital, No. 8 Xishiku Street, Xicheng District, Beijing, 100034, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Gao', 'Affiliation': 'Department of Endocrinology, Peking University First Hospital, No. 8 Xishiku Street, Xicheng District, Beijing, 100034, China.'}, {'ForeName': 'Bo', 'Initials': 'B', 'LastName': 'Jin', 'Affiliation': 'Department of Clinical Laboratory, Peking University First Hospital, No. 8 Xishiku Street, Xicheng District, Beijing, 100034, China.'}, {'ForeName': 'Zheng', 'Initials': 'Z', 'LastName': 'Zhang', 'Affiliation': 'Department of Urology, Peking University First Hospital, No. 8 Xishiku Street, Xicheng District, Beijing, 100034, China. doczhz@aliyun.com.'}, {'ForeName': 'Dong', 'Initials': 'D', 'LastName': 'Fang', 'Affiliation': 'Department of Urology, Peking University First Hospital, No. 8 Xishiku Street, Xicheng District, Beijing, 100034, China. fdmailbox@126.com.'}, {'ForeName': 'Junqing', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Endocrinology, Peking University First Hospital, No. 8 Xishiku Street, Xicheng District, Beijing, 100034, China. 13611167278@139.com.'}, {'ForeName': 'Liqun', 'Initials': 'L', 'LastName': 'Zhou', 'Affiliation': 'Department of Urology, Peking University First Hospital, No. 8 Xishiku Street, Xicheng District, Beijing, 100034, China.'}]",International urology and nephrology,['10.1007/s11255-020-02539-2'] 2973,32621112,Value of Adding Dexmedetomidine in Endoscopic Ultrasound-Guided Celiac Plexus Neurolysis for Treatment of Pancreatic Cancer-Associated Pain.,"BACKGROUND Abdominal and back pain is present in up to 80% of patients with pancreatic cancer and represents a significant cause of morbidity. Celiac plexus neurolysis (CPN) demonstrated good results in relief of pain of upper abdominal malignancy. Dexmedetomidine is alpha-2 adrenoceptor highly selective agonist approved for procedural sedation use. PATIENTS AND METHODS Fifty patients divided in two groups with locally advanced pancreatic cancer-associated abdominal pain underwent endoscopic ultrasound (EUS)-guided CPN using bupivacaine 0.5% alone with alcohol for the first group and bupivacaine 0.5% plus dexmedetomidine in the second. Patients scored their pain according to the Numeric Rating Scale (NRS-11) before, 2, 4, 6, 8, 12, 16, and 24 week after the procedure. RESULTS The study has included 50 patient in two groups. There was no significant difference between the two groups as regards medical, laboratory, or tumor characters. The median pain score decreases from 8.32 ± 0.75 before the procedure to 3.75 ± 3.72 24 week after the procedure in group 1 and from 8.08 ± 0.86 before to 1.67 ± 2.3 24 week after the procedure in group 2. However, there was no significant difference between the two groups in the median pain score during the first 4 weeks. There was no statistically significant difference between the two groups as regards the median survival time. CONCLUSION The addition of dexmedetomidine to bupivacaine 0.5% in EUS-CPN demonstrated beneficial effects as regards the degree and duration of pain relieve with negligible effect on the patient survival.",2020,"There was no statistically significant difference between the two groups as regards the median survival time. ","['Fifty patients divided in two groups with locally advanced pancreatic cancer-associated abdominal pain underwent', 'patients with pancreatic cancer']","['endoscopic ultrasound (EUS)-guided CPN using bupivacaine 0.5% alone with alcohol', 'bupivacaine', 'Dexmedetomidine', 'bupivacaine 0.5% plus dexmedetomidine', 'Endoscopic Ultrasound-Guided Celiac Plexus Neurolysis', 'dexmedetomidine', 'Celiac plexus neurolysis (CPN']","['median pain score', 'median survival time', 'regards medical, laboratory, or tumor characters', 'Numeric Rating Scale (NRS-11', 'relief of pain of upper abdominal malignancy']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0205179', 'cui_str': 'Advanced'}, {'cui': 'C0235974', 'cui_str': 'Carcinoma of pancreas'}, {'cui': 'C0332281', 'cui_str': 'Associated with'}, {'cui': 'C0000737', 'cui_str': 'Abdominal pain'}]","[{'cui': 'C0376443', 'cui_str': 'Endoscopic ultrasonography'}, {'cui': 'C0181090', 'cui_str': 'Guide'}, {'cui': 'C0007572', 'cui_str': 'Celiac nervous plexus structure'}, {'cui': 'C0196878', 'cui_str': 'Neurolysis'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0444500', 'cui_str': '0.5'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0332287', 'cui_str': 'With'}]","[{'cui': 'C0549183', 'cui_str': 'Midline'}, {'cui': 'C0582148', 'cui_str': 'Pain score'}, {'cui': 'C2919552', 'cui_str': 'Survival time'}, {'cui': 'C0199168', 'cui_str': 'Medical service'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0027651', 'cui_str': 'Neoplasm'}, {'cui': 'C0007952', 'cui_str': 'Character'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0564405', 'cui_str': 'Feeling relief'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1282910', 'cui_str': 'Upper'}, {'cui': 'C0000726', 'cui_str': 'Abdominal'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}]",50.0,0.0235451,"There was no statistically significant difference between the two groups as regards the median survival time. ","[{'ForeName': 'Ahmed Abdel Ghafar', 'Initials': 'AAG', 'LastName': 'Saleh', 'Affiliation': 'Department of Internal Medicine, Hepatology & Gastroentrology Unit, Faculty of Medicine, Mansoura University, Mansoura, Egypt. drahmedsaleh1981@gmail.com.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Sultan', 'Affiliation': 'Department of Internal Medicine, Hepatology & Gastroentrology Unit, Faculty of Medicine, Mansoura University, Mansoura, Egypt.'}, {'ForeName': 'Mohamed A', 'Initials': 'MA', 'LastName': 'Hammouda', 'Affiliation': 'Department of Internal Medicine, Hepatology & Gastroentrology Unit, Faculty of Medicine, Mansoura University, Mansoura, Egypt.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Shawki', 'Affiliation': 'Department of Internal Medicine, Hepatology & Gastroentrology Unit, Faculty of Medicine, Mansoura University, Mansoura, Egypt.'}, {'ForeName': 'Mohamed Abd', 'Initials': 'MA', 'LastName': 'El Ghaffar', 'Affiliation': 'Department of Surgical Oncology, Faculty of Medicine, Mansoura University, Mansoura, Egypt.'}]",Journal of gastrointestinal cancer,['10.1007/s12029-020-00449-1'] 2974,32621374,Impact of point of care testing on length of stay of patients in the emergency department: a cluster randomized controlled study.,"BACKGROUND AND OBJECTIVES Crowding is a frequent concern in the emergency department (ED). Laboratory point of care testing (POCT) has been proposed to decrease patients' length of stay (LOS). Our objective was to determine whether an extended panel of POCT solutions could reduce LOS. METHODS This was a single-center, prospective, open-label, controlled cluster-randomized study. Blood test processing was randomized into one-week inclusion periods: interventional arm (laboratory analyses performed on POCT analyzers implemented in the ED) or control arm (central laboratory). The primary endpoint was LOS of patients in the ED. Secondary endpoints were time to result (TTR), ED crowding surrogates, and average total cost of an ED visit in each arm. RESULTS A total of 23,231 patients were included and 20,923 analyzed for the main outcome measure. Mean age was 46 ± 20 years, and 7,905 (36%) underwent blood sampling. Mean LOS was 203 ± 161 and 210 ± 168 minutes (min) in the POCT arm and control arm, respectively. LOS reduction for the entire ED population was -9 min (95% CI -22 to 5; p=0.22) compared to the control arm, and -17 min (95% CI -34.0 to 0.6; p=0.06) for patients undergoing blood sampling. The mean TTR was 28 ± 31 and 79 ± 34 minutes in the POCT and control arm, respectively (TTR reduction -51 min (95% CI -54 to -48; p<0.001). CONCLUSIONS AND RELEVANCE The implementation of an extended panel of POCT solutions in an ED did not significantly reduce the LOS, but reduced the TTR.",2020,"Mean LOS was 203 ± 161 and 210 ± 168 minutes (min) in the POCT arm and control arm, respectively.","['Mean age was 46 ± 20 years, and 7,905 (36%) underwent blood sampling', 'of patients in the emergency department', 'A total of 23,231 patients']","['care testing (POCT', 'care testing']","['LOS reduction', 'LOS', 'length of stay', ""patients' length of stay (LOS"", 'time to result (TTR), ED crowding surrogates, and average total cost of an ED visit in each arm', 'TTR reduction']","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0005834', 'cui_str': 'Collection of blood specimen for laboratory'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0439810', 'cui_str': 'Total'}]","[{'cui': 'C0392366', 'cui_str': 'Tests'}, {'cui': 'C1319069', 'cui_str': 'Point of care testing'}]","[{'cui': 'C0023303', 'cui_str': 'Length of Stay'}, {'cui': 'C0301630', 'cui_str': 'Reduction (chemical)'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0678226', 'cui_str': 'Due to'}, {'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0586082', 'cui_str': 'Emergency department patient visit'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}]",23231.0,0.138528,"Mean LOS was 203 ± 161 and 210 ± 168 minutes (min) in the POCT arm and control arm, respectively.","[{'ForeName': 'P', 'Initials': 'P', 'LastName': 'Hausfater', 'Affiliation': 'Emergency Department, hôpital Pitié-Salpêtrière, APHP, Paris, France.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Hajage', 'Affiliation': 'Sorbonne Université, Département Biostatistique Santé Publique et Information Médicale, Centre de Pharmacoépidémiologie (Cephepi), APHP, CIC-1421, Paris, France.'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Bulsei', 'Affiliation': ""AP-HP URC Eco Ile de France Hôpital de l'Hôtel Dieu, Place du parvis de Notre Dame, 75004 Paris France; Université de Paris, CRESS, INSERM, INRA, France.""}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Canavaggio', 'Affiliation': 'Emergency Department, hôpital Pitié-Salpêtrière, APHP, Paris, France.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Lafourcade', 'Affiliation': 'Unité de Recherche Clinique Salpêtrière - Charles Foix, APHP, Paris, France.'}, {'ForeName': 'A L', 'Initials': 'AL', 'LastName': 'Paquet', 'Affiliation': 'Emergency Department, hôpital Pitié-Salpêtrière, APHP, Paris, France.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Arock', 'Affiliation': 'Sorbonne Université, Paris, France.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Durand-Zaleski', 'Affiliation': ""AP-HP URC Eco Ile de France Hôpital de l'Hôtel Dieu, Place du parvis de Notre Dame, 75004 Paris France; Université de Paris, CRESS, INSERM, INRA, France.""}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Riou', 'Affiliation': 'Emergency Department, hôpital Pitié-Salpêtrière, APHP, Paris, France.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Oueidat', 'Affiliation': 'Biochemisty and Emergency Biology Department, Hôpital Pitié-Salpêtrière, APHP, Paris, France.'}]",Academic emergency medicine : official journal of the Society for Academic Emergency Medicine,['10.1111/acem.14072'] 2975,32621362,"A Multi-Site, Single-Blinded, Prospective Pilot Clinical Trial for Non-Invasive Fat Reduction of the Abdomen and Flanks Using a Monopolar 2 MHz Radiofrequency Device.","BACKGROUND AND OBJECTIVES Demand for non-invasive body sculpting procedures has been steadily increasing, spurring the development of new energy-based technologies. This study assessed the safety and efficacy of a new monopolar 2 MHz radiofrequency (RF) device for fat reduction of the flanks and abdomen. STUDY DESIGN/MATERIALS AND METHODS Nineteen subjects from two clinical sites were enrolled in this study and received a single 15-minute treatment with the 2 MHz RF device. Up to six applicators were placed on the abdomen and/or flanks during the treatment. Follow-up assessments were scheduled 12 weeks after treatment. Efficacy evaluations included live ratings and Global Aesthetic Improvement Scale (GAIS) ratings by blinded investigators, ultrasound measurements of fat thickness, and patient-reported outcomes before and after treatment. RESULTS Investigator assessments showed more than one-point change in the GAIS scale at the 12-week follow-up visit. Ultrasound measurements revealed a significant reduction in fat thickness in both the abdomen (average 24%) and the flanks (22%). The majority of the patients were satisfied with the treatment and mild self-resolving side effects were observed. No serious adverse events were reported. CONCLUSIONS Treatment of local adiposities with a new monopolar 2 MHz radiofrequency device leads to improvement of body contour with no downtime or side effects. Lasers Surg. Med. © 2020 Wiley Periodicals LLC.",2020,"CONCLUSIONS Treatment of local adiposities with a new monopolar 2 MHz radiofrequency device leads to improvement of body contour with no downtime or side effects.",['Nineteen subjects from two clinical sites'],"['MHz RF device', 'Monopolar 2\u2009MHz Radiofrequency Device', 'new monopolar 2\u2009MHz radiofrequency (RF) device']","['mild self-resolving side effects', 'live ratings and Global Aesthetic Improvement Scale (GAIS) ratings by blinded investigators, ultrasound measurements of fat thickness, and patient-reported outcomes', 'GAIS scale', 'safety and efficacy', 'serious adverse events', 'fat thickness']","[{'cui': 'C0450337', 'cui_str': '19'}, {'cui': 'C0205210', 'cui_str': 'Clinical'}, {'cui': 'C0205145', 'cui_str': 'Site'}]","[{'cui': 'C0556962', 'cui_str': 'MHz'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0205314', 'cui_str': 'New'}]","[{'cui': 'C1513302', 'cui_str': 'Common terminology criteria for adverse events grade 1'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C3714811', 'cui_str': 'Resolved'}, {'cui': 'C0001688', 'cui_str': 'adverse effects'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0205246', 'cui_str': 'Generalized'}, {'cui': 'C0014901', 'cui_str': 'Aesthetics'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0041618', 'cui_str': 'Ultrasonography'}, {'cui': 'C0242485', 'cui_str': 'Measurement'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C1280412', 'cui_str': 'Thick'}, {'cui': 'C2987124', 'cui_str': 'Patient Reported Outcome'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",19.0,0.0337518,"CONCLUSIONS Treatment of local adiposities with a new monopolar 2 MHz radiofrequency device leads to improvement of body contour with no downtime or side effects.","[{'ForeName': 'Michael T', 'Initials': 'MT', 'LastName': 'Somenek', 'Affiliation': 'Advanced Plastic Surgery, Washington, District of Columbia.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Ronan', 'Affiliation': 'Blackhawk Plastic Surgery, Danville, California.'}, {'ForeName': 'Troy A', 'Initials': 'TA', 'LastName': 'Pittman', 'Affiliation': 'Advanced Plastic Surgery, Washington, District of Columbia.'}]",Lasers in surgery and medicine,['10.1002/lsm.23295'] 2976,32621368,A pilot randomised controlled trial of assertive treatment including family involvement and home delivery of medication for young adults with opioid use disorder.,"BACKGROUND AND AIMS Although medications for OUD including extended release naltrexone (XR-NTX) have demonstrated effectiveness, adherence is often low. We tested the preliminary efficacy of Youth Opioid Recovery Support (YORS), a multi-component intervention designed to improve engagement and medication adherence for young adults with OUD. DESIGN Single-site randomized controlled trial with 24-week follow-up. SETTING Community substance use disorder treatment program in Baltimore, Maryland, USA. PARTICIPANTS Young adults aged 18-26 years enrolled in inpatient/residential OUD treatment intending to pursue outpatient OUD treatment with XR-NTX. Twenty-one participants were randomized to YORS, and 20 to Treatment as Usual (TAU). The analyzed sample was 66% male. Intervention and comparator Components of YORS include: 1) home delivery of XR-NTX; 2) family engagement; 3) assertive outreach; and 4) contingency management for receipt of XR-NTX doses. The comparator was TAU, which consisted of a standard referral to outpatient care following an inpatient stay. MEASUREMENTS Primary outcomes were number of XR-NTX doses received over 24 weeks and relapse to opioid use (defined as ≥10 days of use within 28 days) at 24 weeks. FINDINGS Participants in the YORS condition received more XR-NTX doses (M = 4.28;SD= 2.27) compared with those in TAU (M = 0.70; SD = 1.17), p< .01.Participants in the YORS group compared with TAU had lower rates of relapse (61% vs. 95%; p< 0.01). Survival analyses revealed group differences on time to relapse with participants in TAU being more likely to relapse sooner compared with participants in the YORS condition (HR 2.72, 95% CI 1.26-5.88, p< .01). CONCLUSIONS The Youth Opioid Recovery Support intervention for extended release naltrexone adherence and opioid relapse prevention among young adults with opioid use disorder appeared to improve treatment and relapse outcomes compared with standard treatment.",2020,"Survival analyses revealed group differences on time to relapse with participants in TAU being more likely to relapse sooner compared with participants in the YORS condition (HR 2.72, 95% CI 1.26-5.88, p< .01). ","['young adults with opioid use disorder', 'Young adults aged 18-26 years enrolled in inpatient/residential OUD treatment intending to pursue outpatient OUD treatment with XR-NTX', 'young adults with OUD', 'Community substance use disorder treatment program in Baltimore, Maryland, USA']","['YORS', 'naltrexone (XR-NTX', 'XR-NTX', 'assertive treatment including family involvement and home delivery of medication', 'Youth Opioid Recovery Support (YORS']","['time to relapse', 'rates of relapse', 'number of XR-NTX doses received over 24 weeks and relapse to opioid use', 'engagement and medication adherence']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C4324621', 'cui_str': 'Opioid use disorder'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0021562', 'cui_str': 'Inpatient'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C1283828', 'cui_str': 'Has intent'}, {'cui': 'C0029921', 'cui_str': 'Outpatient'}, {'cui': 'C0285526', 'cui_str': 'N-telopeptide'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0038586', 'cui_str': 'Substance use disorder'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0004716', 'cui_str': 'Baltimore'}, {'cui': 'C0024858', 'cui_str': 'Maryland'}, {'cui': 'C0041703', 'cui_str': 'United States of America'}]","[{'cui': 'C0001578', 'cui_str': 'Adolescence'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0183683', 'cui_str': 'Support'}, {'cui': 'C0027360', 'cui_str': 'Naltrexone'}, {'cui': 'C0285526', 'cui_str': 'N-telopeptide'}, {'cui': 'C0039798', 'cui_str': 'therapy'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0015576', 'cui_str': 'Family'}, {'cui': 'C1314939', 'cui_str': 'Involvement'}, {'cui': 'C0019857', 'cui_str': 'Home birth'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceutical / biologic product'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0035020', 'cui_str': 'Relapse phase'}, {'cui': 'C0237753', 'cui_str': 'Number'}, {'cui': 'C0285526', 'cui_str': 'N-telopeptide'}, {'cui': 'C0439230', 'cui_str': 'week'}, {'cui': 'C0002772', 'cui_str': 'OPIOIDS'}, {'cui': 'C0042153', 'cui_str': 'utilization'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C2364172', 'cui_str': 'Drug compliance good'}]",21.0,0.137624,"Survival analyses revealed group differences on time to relapse with participants in TAU being more likely to relapse sooner compared with participants in the YORS condition (HR 2.72, 95% CI 1.26-5.88, p< .01). ","[{'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Fishman', 'Affiliation': 'Mountain Manor Treatment Center, 3800 Frederick Avenue, Baltimore, MD, 21229.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Wenzel', 'Affiliation': 'Mountain Manor Treatment Center, 3800 Frederick Avenue, Baltimore, MD, 21229.'}, {'ForeName': 'Hoa', 'Initials': 'H', 'LastName': 'Vo', 'Affiliation': 'Mountain Manor Treatment Center, 3800 Frederick Avenue, Baltimore, MD, 21229.'}, {'ForeName': 'Jared', 'Initials': 'J', 'LastName': 'Wildberger', 'Affiliation': 'Mountain Manor Treatment Center, 3800 Frederick Avenue, Baltimore, MD, 21229.'}, {'ForeName': 'Rachael', 'Initials': 'R', 'LastName': 'Burgower', 'Affiliation': 'Mountain Manor Treatment Center, 3800 Frederick Avenue, Baltimore, MD, 21229.'}]","Addiction (Abingdon, England)",['10.1111/add.15181'] 2977,32621465,[Clinical and neurophysiological effects of dual-target high-frequency rTMS over the primary motor and prefrontal cortex in Parkinson's disease].,"OBJECTIVE To evaluate therapeutic effects of navigational dual-target high-frequency rTMS over the primary motor (M1, bilateral) and the left dorsolateral prefrontal cortex (DLPFC) on clinical dynamics of Parkinson's disease (PD) symptoms in a parallel placebo-controlled study. MATERIAL AND METHODS The study included 46 patients randomized into equal therapeutic and placebo rTMS groups. Navigational therapeutic and placebo10 Hz rTMS was applied over the M1 and DLPFC areas (20 daily sessions, for 3 weeks). Assessment of the dynamics of clinical symptoms was performed using the MDS UPDRS scale (Parts I-IV) before the first session, immediately after 20 sessions, and 4-6 weeks after the rTMS course. Non-motor and mental symptoms were assessed using the Hamilton Depression Rating Scale (HDRS-17), Beck depression inventory (BDI-II), Depression, Anxiety and Stress (DASS-21) scales and the Mini Mental State Examination (MMSE). RESULTS Significant therapeutic effects of rTMS compared to placebo were established: a greater decrease in overall score on the MDS-UPDRS scale (parts I-IV), a decrease in the severity of non-motor (part I) and motor symptoms (part III, with a large therapeutic effect for the symptoms of rigidity, bradykinesia and postural instability), as well as the severity of motor complications of dopamine replacement therapy (part IV). The effects of rTMS on motor symptoms persisted 4 weeks after the end of the stimulation course. It is also important to note significant positive dynamics in both rTMS and placebo groups in the form of comparable reduction in the severity of everyday motor symptoms (MDS-UPDRS part II), improvement of the total scores on MMSE, HDRS, BDI-II, DASS-21. CONCLUSIONS The dual-target high-frequency rTMS over the primary motor cortex (bilateral) and the left dorsolateral prefrontal cortex has positive therapeutic effects on the motor and affective symptoms of Parkinson's disease, which are significantly stronger than that of the placebo stimulation.",2020,"RESULTS Significant therapeutic effects of rTMS compared to placebo were established: a greater decrease in overall score on the MDS-UPDRS scale (parts I-IV), a decrease in the severity of non-motor (part I) and motor symptoms (part III, with a large therapeutic effect for the symptoms of rigidity, bradykinesia and postural instability), as well as the severity of motor complications of dopamine replacement therapy (part IV).","[""Parkinson's disease"", '46 patients randomized into']","['equal therapeutic and placebo rTMS', 'Navigational therapeutic and placebo10', 'rTMS', 'navigational dual-target high-frequency rTMS', 'dual-target high-frequency rTMS', 'Hz rTMS', 'placebo']","['motor and mental symptoms', 'symptoms of rigidity, bradykinesia and postural instability', 'MDS UPDRS scale', 'motor symptoms', 'Hamilton Depression Rating Scale (HDRS-17), Beck depression inventory (BDI-II), Depression, Anxiety and Stress (DASS-21) scales and the Mini Mental State Examination (MMSE', 'severity of non-motor (part I) and motor symptoms', 'overall score on the MDS-UPDRS scale', 'total scores on MMSE, HDRS, BDI-II, DASS-21']","[{'cui': 'C0030567', 'cui_str': ""Parkinson's disease""}, {'cui': 'C0030705', 'cui_str': 'Patient'}]","[{'cui': 'C0205163', 'cui_str': 'Equal'}, {'cui': 'C0087111', 'cui_str': 'Therapeutic procedure'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0205173', 'cui_str': 'Double'}, {'cui': 'C0205212', 'cui_str': 'High frequency'}]","[{'cui': 'C0233401', 'cui_str': 'Psychiatric symptom'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0026837', 'cui_str': 'Muscle rigidity'}, {'cui': 'C0233565', 'cui_str': 'Bradykinesia'}, {'cui': 'C1843921', 'cui_str': 'Postural instability'}, {'cui': 'C3639721', 'cui_str': 'UPDRS Panel'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0426980', 'cui_str': 'Motor symptoms'}, {'cui': 'C0451203', 'cui_str': 'Hamilton rating scale for depression'}, {'cui': 'C1840333', 'cui_str': 'Hypoparathyroidism, deafness, renal disease syndrome'}, {'cui': 'C0451022', 'cui_str': 'Beck depression inventory'}, {'cui': 'C0006448', 'cui_str': 'Burundi'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C1832594', 'cui_str': 'Verloes Bourguignon syndrome'}, {'cui': 'C0451306', 'cui_str': 'Mini-mental state examination'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0439810', 'cui_str': 'Total'}]",46.0,0.0392555,"RESULTS Significant therapeutic effects of rTMS compared to placebo were established: a greater decrease in overall score on the MDS-UPDRS scale (parts I-IV), a decrease in the severity of non-motor (part I) and motor symptoms (part III, with a large therapeutic effect for the symptoms of rigidity, bradykinesia and postural instability), as well as the severity of motor complications of dopamine replacement therapy (part IV).","[{'ForeName': 'L I', 'Initials': 'LI', 'LastName': 'Aftanas', 'Affiliation': 'Research Institute of Physiology and Fundamental Medicine, Novosibirsk, Russia.'}, {'ForeName': 'I V', 'Initials': 'IV', 'LastName': 'Brack', 'Affiliation': 'Research Institute of Physiology and Fundamental Medicine, Novosibirsk, Russia.'}, {'ForeName': 'K I', 'Initials': 'KI', 'LastName': 'Kulikova', 'Affiliation': 'Research Institute of Physiology and Fundamental Medicine, Novosibirsk, Russia.'}, {'ForeName': 'E A', 'Initials': 'EA', 'LastName': 'Filimonova', 'Affiliation': 'Research Institute of Physiology and Fundamental Medicine, Novosibirsk, Russia.'}, {'ForeName': 'S S', 'Initials': 'SS', 'LastName': 'Dzemidovich', 'Affiliation': 'Research Institute of Physiology and Fundamental Medicine, Novosibirsk, Russia.'}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Piradov', 'Affiliation': 'Research Center of Neurology, Moscow, Russia.'}, {'ForeName': 'N A', 'Initials': 'NA', 'LastName': 'Suponeva', 'Affiliation': 'Research Center of Neurology, Moscow, Russia.'}, {'ForeName': 'A G', 'Initials': 'AG', 'LastName': 'Poidasheva', 'Affiliation': 'Research Center of Neurology, Moscow, Russia.'}]",Zhurnal nevrologii i psikhiatrii imeni S.S. Korsakova,['10.17116/jnevro202012005129'] 2978,32621141,Outcome and complications of distal tibia fractures treated with intramedullary nails versus minimally invasive plate osteosynthesis and the role of fibula fixation.,"INTRODUCTION Distal tibia fractures have been managed conservatively as well surgically. A large number of implants have been used for surgical management of these fractures. No treatment method or implant has been proven to be superior to others. In this prospective comparative study, the complications and outcome of distal tibia fractures managed with intramedullary nails and minimally invasive plate osteosynthesis has been compared. Further, the role of fibula fixation in these fractures has been evaluated. MATERIALS AND METHOD One hundred and fifty-four patients of distal tibia fractures with concomitant fibula fractures were randomized into 4 treatment groups based on predetermined inclusion criteria. Functional outcome in these groups was compared based on AOFAS score at 1 year. Intra-operative, post-operative parameters as well as radiological alignment, complications and the need for reoperation were also compared in these groups. RESULT The functional outcome in all four treatment groups was similar. The duration of surgery and radiation exposure was higher with minimally invasive plate osteosynthesis. There was no improvement in outcome with plating of fibula. However, fixation of fibula improved the rotational alignment in distal tibia fractures. CONCLUSION Although there is no difference in outcome of distal tibia fractures with either nailing or minimally invasive plating, nailing is recommended for closed displaced extraarticular fractures. Fixation of fibula should not be done routinely but should be reserved only for a few specific fracture patterns.",2020,"Although there is no difference in outcome of distal tibia fractures with either nailing or minimally invasive plating, nailing is recommended for closed displaced extraarticular fractures.",['One hundred and fifty-four patients of distal tibia fractures with concomitant fibula fractures'],"['intramedullary nails and minimally invasive plate osteosynthesis', 'intramedullary nails versus minimally invasive plate osteosynthesis']","['outcome with plating of fibula', 'distal tibia fractures', 'AOFAS score', 'radiological alignment, complications and the need for reoperation', 'fibula fixation', 'duration of surgery and radiation exposure', 'Outcome and complications of distal tibia fractures']","[{'cui': 'C5191279', 'cui_str': '154'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0262488', 'cui_str': 'Fracture of distal end of tibia'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous'}, {'cui': 'C0149699', 'cui_str': 'Fracture of fibula'}]","[{'cui': 'C0021885', 'cui_str': 'Bone nailing'}, {'cui': 'C0205281', 'cui_str': 'Invasive'}, {'cui': 'C4727954', 'cui_str': 'Plate osteosynthesis'}]","[{'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0407295', 'cui_str': 'Fixation of fracture using plate'}, {'cui': 'C0016068', 'cui_str': 'Bone structure of fibula'}, {'cui': 'C0262488', 'cui_str': 'Fracture of distal end of tibia'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0009566', 'cui_str': 'Complication'}, {'cui': 'C0686904', 'cui_str': 'Patient need for'}, {'cui': 'C0035110', 'cui_str': 'Reoperation'}, {'cui': 'C0185023', 'cui_str': 'Fixation - action'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0015333', 'cui_str': 'Exposure to radiation'}]",154.0,0.0127755,"Although there is no difference in outcome of distal tibia fractures with either nailing or minimally invasive plating, nailing is recommended for closed displaced extraarticular fractures.","[{'ForeName': 'Ankur', 'Initials': 'A', 'LastName': 'Kariya', 'Affiliation': 'Department of Orthopaedics, MGIMS, Sewagram, Wardha, 442 102, India. ankurkariyaorth@gmail.com.'}, {'ForeName': 'Pramod', 'Initials': 'P', 'LastName': 'Jain', 'Affiliation': 'Department of Orthopaedics, MGIMS, Sewagram, Wardha, 442 102, India.'}, {'ForeName': 'Kisan', 'Initials': 'K', 'LastName': 'Patond', 'Affiliation': 'Department of Orthopaedics, MGIMS, Sewagram, Wardha, 442 102, India.'}, {'ForeName': 'Anuj', 'Initials': 'A', 'LastName': 'Mundra', 'Affiliation': 'Department of Community Medicine, MGIMS, Sewagram, Wardha, 442 102, India.'}]",European journal of orthopaedic surgery & traumatology : orthopedie traumatologie,['10.1007/s00590-020-02726-y'] 2979,32621248,Improving screening for physical impairments and access to early physiotherapy after neck dissection surgery: a translational controlled trial.,"PURPOSE Lack of routine screening for a range of physical impairments that can result after neck dissection (ND) may hinder physiotherapy referral and treatment. The purpose of this study was to implement an intervention that targeted both physiotherapists and surgeons to increase their post-operative physical screening of ND patients and in turn improve physiotherapy referral rates. METHODS The authors undertook a translational controlled pilot study, conducted over a 12-month period that utilised three tertiary hospital sites. The target groups were physiotherapists at one intervention site and surgeons at the other intervention site, with the third hospital acting as a control site and receiving usual care. The intervention included a physiotherapy brochure and a clinical pathway for screening, to promote early identification and prompt referral of patients with a physical impairment. The primary outcome variables were screening and referral rates between sites at the study end-point. RESULTS Logistic regression analyses were conducted on n = 174 to assess differences in screening and referral rates between sites. Patients at the intervention site that targeted physiotherapists had four times the odds of being screened for shoulder dysfunction compared to the control site (p = 0.0002), and three times the odds of being referred to physiotherapy (0.0039). There were no statistically significant differences in the odds of patients being screened for shoulder dysfunction or referred to physiotherapy at the intervention site that targeted surgeons. CONCLUSION The translational intervention undertaken by physiotherapists resulted in significantly greater screening and referral rates of post-operative ND patients for physiotherapy.",2020,The translational intervention undertaken by physiotherapists resulted in significantly greater screening and referral rates of post-operative ND patients for physiotherapy.,['physical impairments and access to early physiotherapy after neck dissection surgery'],['physiotherapy brochure and a clinical pathway for screening'],"['shoulder dysfunction', 'screening and referral rates', 'screening and referral rates between sites at the study end-point']","[{'cui': 'C0231171', 'cui_str': 'Physical impairment'}, {'cui': 'C0444454', 'cui_str': 'Access'}, {'cui': 'C1279919', 'cui_str': 'Early'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C0398395', 'cui_str': 'Block dissection of cervical lymph nodes'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}]","[{'cui': 'C0699718', 'cui_str': 'Physiotherapy'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0282654', 'cui_str': 'Clinical Pathways'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}]","[{'cui': 'C0037004', 'cui_str': 'Shoulder region structure'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0199230', 'cui_str': 'Screening for cancer'}, {'cui': 'C0034927', 'cui_str': 'Patient referral'}, {'cui': 'C0205145', 'cui_str': 'Site'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C0444930', 'cui_str': 'End'}]",,0.0406504,The translational intervention undertaken by physiotherapists resulted in significantly greater screening and referral rates of post-operative ND patients for physiotherapy.,"[{'ForeName': 'Aoife C', 'Initials': 'AC', 'LastName': 'McGarvey', 'Affiliation': 'Emergency Medicine Department, Calvary Mater Newcastle Hospital, Edith St, Waratah, Newcastle, NSW, 2298, Australia. Aoife.McGarvey@calvarymater.org.au.'}, {'ForeName': 'Peter G', 'Initials': 'PG', 'LastName': 'Osmotherly', 'Affiliation': 'School of Health Sciences, Faculty of Health, University of Newcastle, Callaghan, NSW, Australia.'}, {'ForeName': 'Gary R', 'Initials': 'GR', 'LastName': 'Hoffman', 'Affiliation': 'School of Medicine and Public Health, Faculty of Health, University of Newcastle, Callaghan, NSW, Australia.'}, {'ForeName': 'Alix', 'Initials': 'A', 'LastName': 'Hall', 'Affiliation': 'School of Medicine and Public Health, Faculty of Health, University of Newcastle, Callaghan, NSW, Australia.'}]",European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery,['10.1007/s00405-020-06142-0'] 2980,32621262,Cost-effectiveness randomized clinical trial on the effect of photobiomodulation therapy for prevention of radiotherapy-induced severe oral mucositis in a Brazilian cancer hospital setting.,"OBJECTIVES This study aimed to assess the cost-effectiveness of photobiomodulation therapy (PBMT) in association with a Preventive Oral Care Program (POCP) compared with POCP alone in the treatment of radiotherapy (RT)-induced oral mucositis (OM). METHODS The cost-effectiveness was evaluated from the health provider perspective and conducted alongside a randomized, double-blind clinical trial. Participants were randomly assigned to either PBMT (n = 25) or control (n = 23) group. The PBMT group participants received PBMT associated with POCP. In the control group, patients were submitted to POCP alone. Costs were identified, quantified, and valued through observation and consultation of the hospital's financial sector database and estimated in Brazilian real and converted to international dollars using the purchasing power parity exchange rate. The incremental cost-effectiveness ratio (ICER) was estimated by considering the prevention of severe OM, interruption of RT, and oral health-related quality of life (OHRQoL) scores, measured by the OHIP-14 and patient-reported OM symptoms scale (PROMS). RESULTS The incremental cost of PBMT was $857.35, and the cost per session was $25.69. The ICER was $ 2867.39 to avoid one case of severe OM and $ 2756.75 to prevent one interruption in RT due to OM. ICER to reduce 1 point in OHIP-14 and PROMS scores were $170.79 and $31.75, respectively. CONCLUSION PBMT is more cost-effective than POCP alone in preventing severe OM, worsening of the OHRQoL, and RT interruptions. PBMT is a promising therapy, especially to avoid interruptions in oncological treatment. TRIAL REGISTRATION ReBEC-RBR-5h4y4n.",2020,"PBMT is more cost-effective than POCP alone in preventing severe OM, worsening of the OHRQoL, and RT interruptions.",['Brazilian cancer hospital setting'],"['ICER', 'photobiomodulation therapy (PBMT', 'POCP alone', 'photobiomodulation therapy', 'PBMT', 'POCP']","['OM symptoms scale (PROMS', 'severe oral mucositis', 'incremental cost of PBMT', 'cost-effectiveness', 'OHIP-14 and PROMS scores', 'severe OM, interruption of RT, and oral health-related quality of life (OHRQoL) scores', 'incremental cost-effectiveness ratio (ICER']","[{'cui': 'C0019999', 'cui_str': 'Cancer hospital'}]","[{'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}, {'cui': 'C4019433', 'cui_str': 'Photobiomodulation Therapy'}, {'cui': 'C0204169', 'cui_str': 'Preventive dental procedure'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}]","[{'cui': 'C0038362', 'cui_str': 'Stomatitis'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0205082', 'cui_str': 'Severe'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C4019433', 'cui_str': 'Photobiomodulation Therapy'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0332453', 'cui_str': 'Disruption'}, {'cui': 'C0034619', 'cui_str': 'radiotherapy'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0439849', 'cui_str': 'Relationships'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0456603', 'cui_str': 'Ratio'}]",,0.135908,"PBMT is more cost-effective than POCP alone in preventing severe OM, worsening of the OHRQoL, and RT interruptions.","[{'ForeName': 'Allisson Filipe', 'Initials': 'AF', 'LastName': 'Lopes Martins', 'Affiliation': 'Laboratory of Oral Pathology, School of Dentistry, Federal University of Goiás, Avenida Universitária Esquina com 1ª Avenida, s/n. Setor Universitário, Goiânia, Goiás, CEP 74605-220, Brazil.'}, {'ForeName': 'Túlio Eduardo', 'Initials': 'TE', 'LastName': 'Nogueira', 'Affiliation': 'Department of Prevention and Oral Rehabilitation, School of Dentistry, Federal University of Goiás, Avenida Universitária Esquina com 1ª Avenida, s/n. Setor Universitário, Goiânia, Goiás, CEP 74605-220, Brazil.'}, {'ForeName': 'Marília Oliveira', 'Initials': 'MO', 'LastName': 'Morais', 'Affiliation': 'Araujo Jorge Cancer Hospital, R. 239, 206 - Setor Universitário, Goiânia, Goiás, CEP 74175-120, Brazil.'}, {'ForeName': 'Sebastião Silvério', 'Initials': 'SS', 'LastName': 'de Sousa-Neto', 'Affiliation': 'Laboratory of Oral Pathology, School of Dentistry, Federal University of Goiás, Avenida Universitária Esquina com 1ª Avenida, s/n. Setor Universitário, Goiânia, Goiás, CEP 74605-220, Brazil.'}, {'ForeName': 'Angélica Ferreira', 'Initials': 'AF', 'LastName': 'Oton-Leite', 'Affiliation': 'Araujo Jorge Cancer Hospital, R. 239, 206 - Setor Universitário, Goiânia, Goiás, CEP 74175-120, Brazil.'}, {'ForeName': 'Marize Campos', 'Initials': 'MC', 'LastName': 'Valadares', 'Affiliation': 'Laboratory of Pharmacology and Cellular Toxicology, Pharmacy Faculty, Federal University of Goias, 5ª Avenida Esquina com Rua 240, s/n. Setor Universitário, Goiânia, Goiás, CEP 74605-170, Brazil.'}, {'ForeName': 'Nilceana Maya', 'Initials': 'NM', 'LastName': 'Aires Freitas', 'Affiliation': 'Department of Radiotherapy, Araujo Jorge Cancer Hospital, R. 239, 206-Setor Universitário, Goiânia, Goiás, CEP 74175-120, Brazil.'}, {'ForeName': 'Cláudio Rodrigues', 'Initials': 'CR', 'LastName': 'Leles', 'Affiliation': 'Department of Prevention and Oral Rehabilitation, School of Dentistry, Federal University of Goiás, Avenida Universitária Esquina com 1ª Avenida, s/n. Setor Universitário, Goiânia, Goiás, CEP 74605-220, Brazil.'}, {'ForeName': 'Elismauro Francisco', 'Initials': 'EF', 'LastName': 'Mendonça', 'Affiliation': 'Department of Prevention and Oral Rehabilitation, School of Dentistry, Federal University of Goiás, Avenida Universitária Esquina com 1ª Avenida, s/n. Setor Universitário, Goiânia, Goiás, CEP 74605-220, Brazil. elismaur@ufg.br.'}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-020-05607-6'] 2981,32621263,A randomized controlled trial on the efficacy of life review therapy targeting incurably ill cancer patients: do their informal caregivers benefit?,"PURPOSE Investigate whether Life Review Therapy and Memory Specificity Training (LRT-MST) targeting incurably ill cancer patients may also have a beneficial effect on caregiving burden, symptoms of anxiety and depression, and posttraumatic growth of the informal caregivers. METHODS Data was collected in the context of a randomized controlled trial (RCT) (secondary analyses) on the effect of LRT-MST among incurably cancer patients. Informal caregivers of participating patients were asked to complete outcome measures at baseline (T0), post-intervention (T1), and 1-month follow-up (T2): caregiver burden (caregivers reaction assessment scale (CRA)), symptoms of anxiety and depression (hospital anxiety and depression scale), and posttraumatic growth (posttraumatic growth inventory). Linear mixed models (intention to treat) were used to assess group differences in changes over time. Effect size and independent samples t tests were used to assess group differences at T1 and T2. RESULTS In total, 64 caregivers participated. At baseline, 56% of the caregivers experienced anxiety and 30% depression. No significant effect was found on these symptoms nor on posttraumatic growth or most aspects of caregiver burden. There was a significant effect of LRT-MST on the course of self-esteem (subscale CRA) (p = 0.013). Effect size was moderate post-intervention (ES = - 0.38, p = 0.23) and at 3-month follow-up (ES = 0.53, p = 0.083). CONCLUSIONS Many caregivers of incurably ill cancer patients experience symptoms of anxiety and depression. LRT-MST does not improve symptoms of depression and anxiety, negative aspects of caregiver burden, or posttraumatic growth. LRT-MST may have a protective effect on self-esteem of informal caregivers (positive aspect of caregiver burden). TRIAL REGISTRATION NUMBER Netherlands Trial Register (NTR 2256), registered on 23-3-2010.",2020,"LRT-MST does not improve symptoms of depression and anxiety, negative aspects of caregiver burden, or posttraumatic growth.","['Informal caregivers of participating patients', '64 caregivers participated', 'incurably cancer patients', 'ill cancer patients', 'Many caregivers of incurably ill cancer patients experience symptoms of anxiety and depression']","['Life Review Therapy and Memory Specificity Training (LRT-MST', 'LRT-MST']","['course of self-esteem (subscale CRA', '1-month follow-up (T2): caregiver burden (caregivers reaction assessment scale (CRA)), symptoms of anxiety and depression (hospital anxiety and depression scale), and posttraumatic growth (posttraumatic growth inventory', 'symptoms of depression and anxiety, negative aspects of caregiver burden, or posttraumatic growth']","[{'cui': 'C1319882', 'cui_str': 'Informal caregiver'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0006826', 'cui_str': 'Malignant neoplastic disease'}, {'cui': 'C0231218', 'cui_str': 'Malaise'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}]","[{'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C0013216', 'cui_str': 'Drug therapy'}, {'cui': 'C0025260', 'cui_str': 'Memory function'}, {'cui': 'C0037791', 'cui_str': 'Specificity'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}]","[{'cui': 'C0750729', 'cui_str': 'Courses'}, {'cui': 'C0036597', 'cui_str': 'Self-esteem'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0443286', 'cui_str': 'Reaction'}, {'cui': 'C0450973', 'cui_str': 'Assessment scales'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011570', 'cui_str': 'Depression'}, {'cui': 'C3539657', 'cui_str': 'Hospital anxiety and depression scale'}, {'cui': 'C4704809', 'cui_str': 'Posttraumatic Growth'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0205160', 'cui_str': 'Negative'}]",64.0,0.193034,"LRT-MST does not improve symptoms of depression and anxiety, negative aspects of caregiver burden, or posttraumatic growth.","[{'ForeName': 'Gitta', 'Initials': 'G', 'LastName': 'Kleijn', 'Affiliation': 'Department of Clinical, Neuro- & Developmental Psychology, Vrije Universiteit Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Birgit I', 'Initials': 'BI', 'LastName': 'Lissenberg-Witte', 'Affiliation': 'Department of Epidemiology and Biostatistics, Amsterdam UMC, location VUmc, Amsterdam, Netherlands.'}, {'ForeName': 'Ernst T', 'Initials': 'ET', 'LastName': 'Bohlmeijer', 'Affiliation': 'Department of Psychology, Health & Technology, University Twente, Enschede, Netherlands.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Willemsen', 'Affiliation': 'Center for Psychosocial Oncology Care, Ingeborg Douwes Center, Amsterdam, Netherlands.'}, {'ForeName': 'Annemarie', 'Initials': 'A', 'LastName': 'Becker-Commissaris', 'Affiliation': 'Cancer Center Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Corien M', 'Initials': 'CM', 'LastName': 'Eeltink', 'Affiliation': 'Cancer Center Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Anna M E', 'Initials': 'AME', 'LastName': 'Bruynzeel', 'Affiliation': 'Cancer Center Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Maurice J', 'Initials': 'MJ', 'LastName': 'van der Vorst', 'Affiliation': 'Department of Medical Oncology, Amsterdam UMC, location VUmc, Amsterdam, Netherlands.'}, {'ForeName': 'Pim', 'Initials': 'P', 'LastName': 'Cuijpers', 'Affiliation': 'Department of Clinical, Neuro- & Developmental Psychology, Vrije Universiteit Amsterdam, Amsterdam, Netherlands.'}, {'ForeName': 'Irma M', 'Initials': 'IM', 'LastName': 'Verdonck-de Leeuw', 'Affiliation': 'Department of Clinical, Neuro- & Developmental Psychology, Vrije Universiteit Amsterdam, Amsterdam, Netherlands. im.verdonck@amsterdamumc.nl.'}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-020-05592-w'] 2982,32621316,Pilot randomised controlled trial reporting should be focused.,,2020,,[],[],[],[],[],[],,0.223126,,"[{'ForeName': 'E', 'Initials': 'E', 'LastName': 'Muggleton', 'Affiliation': 'Technical University of Munich, Germany.'}]",Anaesthesia,['10.1111/anae.15189'] 2983,32621309,Pilot randomised controlled trial reporting should be focused: a reply.,,2020,,[],[],[],[],[],[],,0.205819,,"[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Charlesworth', 'Affiliation': 'Wythenshawe Hospital, Manchester, UK.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Deng', 'Affiliation': 'Auckland City Hospital, Auckland, New Zealand.'}]",Anaesthesia,['10.1111/anae.15199'] 2984,32621630,A Mindfulness-Based Intervention as a Supportive Care Strategy for Patients with Metastatic Non-Small Cell Lung Cancer and their Spouses: Results of a 3-Arm Pilot Randomized Controlled Trial.,"BACKGROUND Although mindfulness-based interventions have been widely examined in patients with non-metastatic cancer, the feasibility and efficacy of these types of programs are largely unknown for those with advanced disease. We pilot-tested a couple-based mediation (CBM) relative to a supportive-expressive (SE) and a usual care (UC) arm targeting psycho-spiritual distress in patients with metastatic lung cancer and their spousal caregivers. PATIENTS AND METHODS Seventy-five patient-caregiver dyads completed baseline self-report measures and were then randomized to one of the three arms. Couples in the CBM and SE groups attended four, 60 min. sessions that were delivered via videoconference. All dyads were reassessed 1 and 3 months later. RESULTS A priori feasibility benchmarks were met. Although attendance was high in both groups, dyads in the CBM group indicated greater benefit of the sessions than those in the SE group (patients, CBM mean=2.63, SE mean=2.20, P=.003; spouse, CBM mean=2.71, SE mean=2.00, P=.005). Compared with the UC group, patients in the CBM group reported significantly lower depressive symptoms (P=.05; d=.53) and marginally reduced cancer-related stress (P=.07; d=.68). Medium effect sizes in favor of the CBM compared with the SE group for depressive symptoms (d=.59) and cancer-related stress (d=.54) were found. Spouses in the CBM group reported significantly lower depressive symptoms (P<.01; d=.74) compared with those in the UC group. CONCLUSION It seems feasible and possibly efficacious to deliver dyadic interventions via videoconference to couples coping with metastatic lung cancer. Mindfulness-based interventions may be of value to managing psychological symptoms in the palliative care setting.",2020,"Spouses in the CBM group reported significantly lower depressive symptoms (P<.01; d=.74) compared with those in the UC group. ","['patients with metastatic lung cancer and their spousal caregivers', 'patients with non-metastatic cancer', 'Patients with Metastatic Non-Small Cell Lung Cancer and their Spouses', 'Seventy-five patient-caregiver dyads completed baseline self-report measures']","['SE', 'couple-based mediation (CBM) relative to a supportive-expressive (SE) and a usual care (UC) arm targeting psycho-spiritual distress', 'UC', 'CBM']",['depressive symptoms'],"[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0153676', 'cui_str': 'Secondary malignant neoplasm of lung'}, {'cui': 'C0085537', 'cui_str': 'Caregiver'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0278987', 'cui_str': 'Metastatic non-small cell lung cancer'}, {'cui': 'C0162409', 'cui_str': 'Spouse'}, {'cui': 'C4319621', 'cui_str': '75'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0079809', 'cui_str': 'Measure'}]","[{'cui': 'C0010222', 'cui_str': 'Couples'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0680727', 'cui_str': 'Mediation'}, {'cui': 'C3875154', 'cui_str': 'Relative to'}, {'cui': 'C0003798', 'cui_str': 'Armenia'}, {'cui': 'C0150081', 'cui_str': 'Spiritual distress'}]","[{'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]",,0.0403801,"Spouses in the CBM group reported significantly lower depressive symptoms (P<.01; d=.74) compared with those in the UC group. ","[{'ForeName': 'Kathrin', 'Initials': 'K', 'LastName': 'Milbury', 'Affiliation': 'Departent of Behavioral Science, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Yisheng', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Department of Biostatistics, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Sania', 'Initials': 'S', 'LastName': 'Durrani', 'Affiliation': 'Departent of Behavioral Science, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Zhongxing', 'Initials': 'Z', 'LastName': 'Liao', 'Affiliation': 'Deparment of Radiation Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Anne S', 'Initials': 'AS', 'LastName': 'Tsao', 'Affiliation': 'Department of Head and Neck/Thoracic Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Cindy', 'Initials': 'C', 'LastName': 'Carmack', 'Affiliation': 'Department of Palliative, Rehabilitation & Integrative Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Lorenzo', 'Initials': 'L', 'LastName': 'Cohen', 'Affiliation': 'Department of Palliative, Rehabilitation & Integrative Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Bruera', 'Affiliation': 'Department of Palliative, Rehabilitation & Integrative Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}]",The oncologist,['10.1634/theoncologist.2020-0125'] 2985,32621644,"A Double-Blind, Randomized, Placebo-Controlled Pilot Trial of Atorvastatin for Nephrogenic Diabetes Insipidus in Lithium-Users.","OBJECTIVE Lithium remains an important treatment for mood disorders but is associated with kidney disease. Nephrogenic diabetes insipidus (NDI) is associated with up to 3-fold risk of incident chronic kidney disease amongst lithium users. There is limited randomized controlled trials (RCT) for treatments of lithium-induced NDI, and existing therapies can be poorly tolerated. Therefore, novel treatments are needed for lithium-induced NDI. METHOD We conducted a 12-week double-blind pilot RCT to assess the feasibility and efficacy of 20mg/day atorvastatin vs. placebo in the treatment of NDI in chronic lithium users. Patients, recruited between September 2017 and October 2018, were aged 18 to 85, currently on a stable dose of lithium, and determined to have NDI. RESULTS Urinary osmolality (UOsm) at 12 weeks adjusted for baseline was not statistically different between groups (+39.6 mOsm/Kg [95% CI, -35.3, 114.5] in atorvastatin compared to placebo groups). Secondary outcomes of fluid intake and aquaporin-2 excretions at 12 weeks adjusted for baseline were -0.13 L [95% CI, -0.54, 0.28] and 98.68 [95% CI, -190.34, 387.70], respectively. A moderate effect size was observed for improvements in baseline UOsm by ≥100mOsm/Kg at 12 weeks in patients who received atorvastatin compared to placebo (38.45% (10/26) vs. 22.58% (7/31); Cohen's d = 0.66). CONCLUSION Among lithium users with NDI, atorvastatin 20mg/day did not significantly improve urinary osmolality compared to placebo over a 12-week period. Larger confirmatory trials with longer follow-up periods may help to further assess the effects of statins on NDI, especially within patients with more severe NDI.",2020,"A moderate effect size was observed for improvements in baseline UOsm by ≥100mOsm/Kg at 12 weeks in patients who received atorvastatin compared to placebo (38.45% (10/26) vs. 22.58% (7/31); Cohen's d = 0.66). ","['Nephrogenic Diabetes Insipidus in Lithium-Users', 'Patients, recruited between September 2017 and October 2018, were aged 18 to 85, currently on a stable dose of lithium, and determined to have NDI', 'chronic lithium users', 'patients with more severe NDI']","['atorvastatin', 'Nephrogenic diabetes insipidus (NDI', 'Placebo', 'NDI, atorvastatin', 'Atorvastatin', 'atorvastatin vs. placebo', 'placebo']","['feasibility and efficacy', 'urinary osmolality', 'fluid intake and aquaporin-2 excretions', 'Urinary osmolality (UOsm']","[{'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0023870', 'cui_str': 'Lithium'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0521116', 'cui_str': 'Current'}, {'cui': 'C0205360', 'cui_str': 'Stable'}, {'cui': 'C0178602', 'cui_str': 'Dosage'}, {'cui': 'C0521095', 'cui_str': 'Determined by'}, {'cui': 'C0205191', 'cui_str': 'Chronic'}, {'cui': 'C0205082', 'cui_str': 'Severe'}]","[{'cui': 'C0286651', 'cui_str': 'atorvastatin'}, {'cui': 'C0011849', 'cui_str': 'Diabetes mellitus'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0086741', 'cui_str': 'Osmolality'}, {'cui': 'C0429791', 'cui_str': 'Fluid intake'}, {'cui': 'C0213238', 'cui_str': 'Aquaporin-2'}, {'cui': 'C0221102', 'cui_str': 'Excretory function'}]",,0.535592,"A moderate effect size was observed for improvements in baseline UOsm by ≥100mOsm/Kg at 12 weeks in patients who received atorvastatin compared to placebo (38.45% (10/26) vs. 22.58% (7/31); Cohen's d = 0.66). ","[{'ForeName': 'Jocelyn', 'Initials': 'J', 'LastName': 'Fotso Soh', 'Affiliation': 'Geri-PARTy Research Group, Jewish General Hospital, Montreal, Canada.'}, {'ForeName': 'Serge', 'Initials': 'S', 'LastName': 'Beaulieu', 'Affiliation': 'Douglas Mental Health University Institute, Montreal, Canada.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Trepiccione', 'Affiliation': 'Division of Nephrology, University of Naples, Naples, Italy.'}, {'ForeName': 'Outi', 'Initials': 'O', 'LastName': 'Linnaranta', 'Affiliation': 'Douglas Mental Health University Institute, Montreal, Canada.'}, {'ForeName': 'Gabriela', 'Initials': 'G', 'LastName': 'Torres-Platas', 'Affiliation': 'Geri-PARTy Research Group, Jewish General Hospital, Montreal, Canada.'}, {'ForeName': 'Robert W', 'Initials': 'RW', 'LastName': 'Platt', 'Affiliation': 'Department of Epidemiology, Biostatistics and Occupational Health, McGill University Health Centre, Montreal, Canada.'}, {'ForeName': 'Suzane', 'Initials': 'S', 'LastName': 'Renaud', 'Affiliation': 'Douglas Mental Health University Institute, Montreal, Canada.'}, {'ForeName': 'Chien-Lin', 'Initials': 'CL', 'LastName': 'Su', 'Affiliation': 'Department of Epidemiology, Biostatistics and Occupational Health, McGill University Health Centre, Montreal, Canada.'}, {'ForeName': 'Istvan', 'Initials': 'I', 'LastName': 'Mucsi', 'Affiliation': 'Division of Nephrology, University Health Network, University of Toronto (UofT), Toronto, Canada.'}, {'ForeName': 'Luciano', 'Initials': 'L', 'LastName': ""D'Apolito"", 'Affiliation': 'Biogem S.c.a.r.l, Istituto di Ricerche Genetiche ""Gaetano Salvatore"", Ariano Irpino, Italy.'}, {'ForeName': 'Benoit H', 'Initials': 'BH', 'LastName': 'Mulsant', 'Affiliation': 'Department of Psychiatry, Centre for Addiction and Mental Health & Department of Psychiatry, University of Toronto, Montreal, Canada.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Levinson', 'Affiliation': 'Department of Psychiatry, Centre for Addiction and Mental Health & Department of Psychiatry, University of Toronto, Montreal, Canada.'}, {'ForeName': 'Sybille', 'Initials': 'S', 'LastName': 'Saury', 'Affiliation': 'Douglas Mental Health University Institute, Montreal, Canada.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Müller', 'Affiliation': 'Department of Psychiatry, Centre for Addiction and Mental Health & Department of Psychiatry, University of Toronto, Montreal, Canada.'}, {'ForeName': 'Ayal', 'Initials': 'A', 'LastName': 'Schaffer', 'Affiliation': 'Department of Psychiatry, Sunnybrook Research Institute, University of Toronto, Montreal, Canada.'}, {'ForeName': 'Annemiek', 'Initials': 'A', 'LastName': 'Dols', 'Affiliation': 'Amsterdam UMC, location Vumc, Department of Psychiatry, GGZinGeest, Neuroscience, Amsterdam, Netherlands.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Low', 'Affiliation': 'Department of Psychiatry, McGill University Health Centre, Montreal, Canada.'}, {'ForeName': 'Pablo', 'Initials': 'P', 'LastName': 'Cervantes', 'Affiliation': 'Department of Psychiatry, McGill University Health Centre, Montreal, Canada.'}, {'ForeName': 'Birgitte M', 'Initials': 'BM', 'LastName': 'Christensen', 'Affiliation': 'Department of Biomedicine, University of Aarhus, Denmark.'}, {'ForeName': 'Nathan', 'Initials': 'N', 'LastName': 'Herrmann', 'Affiliation': 'Department of Psychiatry, Sunnybrook Research Institute, University of Toronto, Montreal, Canada.'}, {'ForeName': 'Tarek', 'Initials': 'T', 'LastName': 'Rajji', 'Affiliation': 'Department of Psychiatry, Centre for Addiction and Mental Health & Department of Psychiatry, University of Toronto, Montreal, Canada.'}, {'ForeName': 'Soham', 'Initials': 'S', 'LastName': 'Rej', 'Affiliation': 'Geri-PARTy Research Group, Jewish General Hospital, Montreal, Canada.'}]",Bipolar disorders,['10.1111/bdi.12973'] 2986,32621657,Effects of hyaluronic acid injected using the mesogun injector with stamp-type microneedle on skin hydration.,"INTRODUCTION The elasticity of the skin and its capacity to hold water decrease with aging because of the loss of hyaluronic acid (HA) in the skin. Therefore, there is an increasing interest in the use of HA fillers in skin rejuvenation beyond its conventional use which is supplementing decreased dermis volume and filling deep wrinkles. OBJECTIVE We investigated the efficacy and safety of a novel device (Dermashine® balance™) that injects HA into the dermis using a stamp-type microneedle for maintenance of hydration and elasticity of the skin. METHODS A single-center randomized double-blinded parallel-group clinical study was conducted, and 60 participants enrolled in this study. The subjects were randomized to receive HA injections or a placebo 3 times across the face using an automatic intradermal injector. At 4, 8, and 12 weeks after the treatment, skin hydration was measured using a corneometer. RESULTS The patients who received HA showed significantly greater skin hydration than those who received the placebo. However, a significant difference was not noted in skin elasticity between the groups. No severe adverse event were reported. CONCLUSION Intradermal supplementation of HA using mesogun multi-needle injector may be a safe and effective treatment for improving skin hydration. This article is protected by copyright. All rights reserved.",2020,The elasticity of the skin and its capacity to hold water decrease with aging because of the loss of hyaluronic acid (HA) in the skin.,['60 participants enrolled in this study'],"['novel device (Dermashine® balance', 'hyaluronic acid', 'HA injections', 'placebo']","['severe adverse event', 'efficacy and safety', 'skin hydration', 'skin elasticity']","[{'cui': 'C0008972', 'cui_str': 'Clinical Study'}]","[{'cui': 'C0205314', 'cui_str': 'New'}, {'cui': 'C0025080', 'cui_str': 'Biomedical equipment'}, {'cui': 'C0014653', 'cui_str': 'Equilibrium'}, {'cui': 'C0020196', 'cui_str': 'hyaluronic acid'}, {'cui': 'C0021485', 'cui_str': 'Injection of therapeutic agent'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C1519275', 'cui_str': 'Common terminology criteria for adverse events grade 3'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0444099', 'cui_str': 'Specimen from skin'}, {'cui': 'C1321013', 'cui_str': 'Hydration status'}, {'cui': 'C0423761', 'cui_str': 'Skin elasticity'}]",60.0,0.072965,The elasticity of the skin and its capacity to hold water decrease with aging because of the loss of hyaluronic acid (HA) in the skin.,"[{'ForeName': 'Sun Young', 'Initials': 'SY', 'LastName': 'Choi', 'Affiliation': 'Department of Dermatology, Seoul Paik Hospital, Inje University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Eun Jung', 'Initials': 'EJ', 'LastName': 'Ko', 'Affiliation': 'Department of Dermatology, National Police Hospital, Seoul, Korea.'}, {'ForeName': 'Kwang Ho', 'Initials': 'KH', 'LastName': 'Yoo', 'Affiliation': 'Department of Dermatology, Chung-Ang University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Hye Sung', 'Initials': 'HS', 'LastName': 'Han', 'Affiliation': 'Department of Dermatology, Chung-Ang University College of Medicine, Seoul, Korea.'}, {'ForeName': 'Beom Joon', 'Initials': 'BJ', 'LastName': 'Kim', 'Affiliation': 'Department of Dermatology, Chung-Ang University College of Medicine, Seoul, Korea.'}]",Dermatologic therapy,['10.1111/dth.13963'] 2987,32621663,A comparative study of topical tacrolimus and topical triamcinolone acetonide in nodular scabies.,"OBJECTIVE The aim of this study was to compare the efficacy and safety of 0.1% triamcinolone acetonide and 0.1% tacrolimus ointment for the treatment of such nodular lesions of scabies. METHODS In this double-blind randomized controlled trial, fifty Indian men with postscabeitic persistent nodular lesions over the external genitalia, were enrolled. They were randomized into two groups to receive either triamcinolone acetonide 0.1% ointment twice daily, or tacrolimus ointment 0.03% twice daily over the nodular lesions for 2 weeks. All patients were followed up on three visits: 1, 2, and 6 weeks, for assessment. Efficacy was evaluated by 5-point range investigator-assessed VAS, and a 4-point severity of pruritus scale (SPS) score. RESULTS The mean VAS score was higher in triamcinolone group compared to tacrolimus group at both follow ups, although statistically significant only at 2 nd week visit. The fall in mean SPS at both follow ups was higher in the steroid group, but the difference was not statistically significant. DISCUSSION Although both treatment options provided satisfactory short term improvement, triamcinolone ointment proved to be more efficacious. CONCLUSIONS Mid-potency TCS are more effective in treatment of nodular lesions of NS/PSP. Topical CNIs may be considered if prolonged topical therapy is warranted. This article is protected by copyright. All rights reserved.",2020,"The mean VAS score was higher in triamcinolone group compared to tacrolimus group at both follow ups, although statistically significant only at 2 nd week visit.","['nodular scabies', 'such nodular lesions of scabies', 'fifty Indian men with postscabeitic persistent nodular lesions over the external genitalia, were enrolled']","['triamcinolone acetonide 0.1% ointment twice daily, or tacrolimus ointment', 'triamcinolone', 'triamcinolone ointment', 'topical tacrolimus and topical triamcinolone acetonide', 'Topical CNIs', 'triamcinolone acetonide and 0.1% tacrolimus ointment', 'tacrolimus']","['efficacy and safety', 'Efficacy', '5-point range investigator-assessed VAS, and a 4-point severity of pruritus scale (SPS) score', 'mean VAS score', 'mean SPS']","[{'cui': 'C0344064', 'cui_str': 'Post-scabetic nodules'}, {'cui': 'C0205297', 'cui_str': 'Nodular'}, {'cui': 'C0221198', 'cui_str': 'Lesion'}, {'cui': 'C0036262', 'cui_str': 'Infestation by Sarcoptes scabiei var hominis'}, {'cui': 'C0002460', 'cui_str': 'American Indian race'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0042993', 'cui_str': 'Vulval structure'}]","[{'cui': 'C0040866', 'cui_str': 'Triamcinolone acetonide'}, {'cui': 'C4517420', 'cui_str': '0.1'}, {'cui': 'C0028912', 'cui_str': 'Ointment'}, {'cui': 'C0585361', 'cui_str': 'Twice a day'}, {'cui': 'C1253468', 'cui_str': 'Tacrolimus Topical Ointment'}, {'cui': 'C0040864', 'cui_str': 'Triamcinolone'}, {'cui': 'C0939241', 'cui_str': 'Tacrolimus-containing product in cutaneous dose form'}, {'cui': 'C0332237', 'cui_str': 'Topical'}, {'cui': 'C0085149', 'cui_str': 'Tacrolimus'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C3542016', 'cui_str': 'Concept model range'}, {'cui': 'C0035173', 'cui_str': 'Researcher'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0439793', 'cui_str': 'Severities'}, {'cui': 'C0033774', 'cui_str': 'Itching'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0444504', 'cui_str': 'Mean'}]",50.0,0.0529841,"The mean VAS score was higher in triamcinolone group compared to tacrolimus group at both follow ups, although statistically significant only at 2 nd week visit.","[{'ForeName': 'Mukesh', 'Initials': 'M', 'LastName': 'Manjhi', 'Affiliation': 'Department of Dermatology, Hamdard Institute of Medical Sciences and Research & HAH CENTENARY Hospital, Jamia Hamdard, Hamdard Nagar, New Delhi.'}, {'ForeName': 'Pravesh', 'Initials': 'P', 'LastName': 'Yadav', 'Affiliation': 'Department of Dermatology, Lady Hardinge Medical College and associated hospital, Shaheed Bhagat Singh Marg New Delhi, Delhi.'}, {'ForeName': 'Sneha', 'Initials': 'S', 'LastName': 'Mohan', 'Affiliation': 'Department of Microbiology, School of Medical Sciences and Research & SHARDA Hospital, Knowledge Park III, Greater Noida, Uttar Pradesh.'}, {'ForeName': 'Sidharth', 'Initials': 'S', 'LastName': 'Sonthalia', 'Affiliation': 'Medical Director and Senior Consultant Dermatologist, Department of Dermatology and Dermatosurgery, Skinnocence: The Skin Clinic and Research Center, Gurugram, Haryana, India.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Ramesh', 'Affiliation': 'Department of Dermatology, Hamdard Institute of Medical Sciences and Research & HAH CENTENARY Hospital, Jamia Hamdard, Hamdard Nagar, New Delhi.'}, {'ForeName': 'Varun', 'Initials': 'V', 'LastName': 'Kashyap', 'Affiliation': 'Department of Community Medicine, Hamdard Institute of Medical Sciences and Research & HAH CENTENARY Hospital, Jamia Hamdard, Hamdard Nagar, New Delhi.'}]",Dermatologic therapy,['10.1111/dth.13954'] 2988,32565243,"Six high-intensity interval training sessions over 5 days increases maximal oxygen uptake, endurance capacity and sub-maximal exercise fat oxidation as much as 6 high-intensity interval training sessions over 2 weeks.","BACKGROUND High-intensity interval training (HIIT) induces similar or even superior adaptations compared to continuous endurance training. Indeed, just 6 HIIT sessions over 2 weeks significantly improves maximal oxygen uptake (VO 2max ), submaximal exercise fat oxidation and endurance performance. Whether even faster adaptations can be achieved with HIIT is not known. Thus, we aimed to determine whether 2 sessions of HIIT per day, separated by 3 h, every other day for 5 days (double HIIT (HIIT-D), n = 15 participants) can increase VO 2max , submaximal exercise fat oxidation and endurance capacity as effectively as 6 sessions of HIIT over 2 weeks (single HIIT, single high-intensity interval group (HIIT-S), n = 13). METHODS Each training session consisted of 10*60 s of cycling at 100% of VO 2max interspersed with 75 s of low-intensity cycling at 60 W. Pre- and post-training assessments included VO 2max , time to exhaustion at ∼80% of VO 2max and 60-min cycling trials at ∼67% of VO 2max . RESULTS Similar increases (p < 0.05) in VO 2max (HIIT-D 7.7% vs. HIIT-S 6.0%, p > 0.05) and endurance capacity (HIIT-D 80.1%, HIIT-S 79.2%, p > 0.05) were observed in the 2 groups. Submaximal exercise carbohydrate oxidation was reduced in the 2 groups after exercise training (HIIT-D 9.2%, p = 0.14 vs. HIIT-S 18.8%, p = 0.14) while submaximal exercise fat oxidation was significantly increased in HIIT-D (15.5%; p = 0.048) but not in HIIT-S (9.3%; p = 0.290). CONCLUSION Six HIIT sessions over 5 days was as effective in increasing VO 2max and endurance capacity and was more effective in improving submaximal exercise fat oxidation than 6 HIIT sessions over 2 weeks.",2020,"Submaximal exercise carbohydrate oxidation was reduced in the 2 groups after exercise training (HIIT-D 9.2%, p = 0.14 vs. HIIT-S 18.8%, p = 0.14) while submaximal exercise fat oxidation was significantly increased in HIIT-D (15.5%; p = 0.048) but not in HIIT-S (9.3%; p = 0.290). ",[],"['High-intensity interval training (HIIT', 'VO 2max interspersed with 75 s of low-intensity cycling at 60 W. Pre- and post-training assessments included VO 2max , time to exhaustion at ∼80% of VO 2max and 60-min cycling trials at ∼67% of VO 2max ']","['submaximal exercise fat oxidation', 'VO 2max', 'VO 2max and endurance capacity', 'endurance capacity', 'maximal oxygen uptake, endurance capacity and sub-maximal exercise fat oxidation', 'VO 2max , submaximal exercise fat oxidation and endurance capacity', 'maximal oxygen uptake (VO 2max ), submaximal exercise fat oxidation and endurance performance', 'Submaximal exercise carbohydrate oxidation']",[],"[{'cui': 'C4277545', 'cui_str': 'High-intensity interval training'}, {'cui': 'C0596836', 'cui_str': 'Light intensity'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0687676', 'cui_str': 'After values'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0332257', 'cui_str': 'Including'}, {'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0392674', 'cui_str': 'Exhaustion'}, {'cui': 'C0439232', 'cui_str': 'min'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]","[{'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C0030011', 'cui_str': 'Oxidation'}, {'cui': 'C0518031', 'cui_str': 'Endurance'}, {'cui': 'C0205289', 'cui_str': 'Maximal'}, {'cui': 'C0429627', 'cui_str': 'Oxygen uptake'}, {'cui': 'C0542339', 'cui_str': 'Inferior'}, {'cui': 'C0007004', 'cui_str': 'carbohydrates'}]",,0.049312,"Submaximal exercise carbohydrate oxidation was reduced in the 2 groups after exercise training (HIIT-D 9.2%, p = 0.14 vs. HIIT-S 18.8%, p = 0.14) while submaximal exercise fat oxidation was significantly increased in HIIT-D (15.5%; p = 0.048) but not in HIIT-S (9.3%; p = 0.290). ","[{'ForeName': 'Muhammed M', 'Initials': 'MM', 'LastName': 'Atakan', 'Affiliation': 'Division of Nutrition and Metabolism in Exercise, Faculty of Sport Sciences, Hacettepe University, Ankara 06690, Turkey; Institute for Health and Sport, Victoria University, Footscray, Melbourne, VIA 3011, Australia.'}, {'ForeName': 'Yasemin', 'Initials': 'Y', 'LastName': 'Güzel', 'Affiliation': 'Division of Nutrition and Metabolism in Exercise, Faculty of Sport Sciences, Hacettepe University, Ankara 06690, Turkey.'}, {'ForeName': 'Süleyman', 'Initials': 'S', 'LastName': 'Bulut', 'Affiliation': 'Division of Nutrition and Metabolism in Exercise, Faculty of Sport Sciences, Hacettepe University, Ankara 06690, Turkey.'}, {'ForeName': 'Nazan Ş', 'Initials': 'NŞ', 'LastName': 'Koşar', 'Affiliation': 'Division of Nutrition and Metabolism in Exercise, Faculty of Sport Sciences, Hacettepe University, Ankara 06690, Turkey.'}, {'ForeName': 'Glenn K', 'Initials': 'GK', 'LastName': 'McConell', 'Affiliation': 'Institute for Health and Sport, Victoria University, Footscray, Melbourne, VIA 3011, Australia. Electronic address: glenn.mcconell@vu.edu.au.'}, {'ForeName': 'Hüseyin H', 'Initials': 'HH', 'LastName': 'Turnagöl', 'Affiliation': 'Division of Nutrition and Metabolism in Exercise, Faculty of Sport Sciences, Hacettepe University, Ankara 06690, Turkey. Electronic address: deniz@hacettepe.edu.tr.'}]",Journal of sport and health science,['10.1016/j.jshs.2020.06.008'] 2989,32621696,Patients use more topical medication when the medications come in a larger container.,"INTRODUCTION Research shows that individuals consume more calories when provided with a larger portion size. It is unclear if similar behavior translates to topical medication use. The impact of container size and provider instructions on patient usage of topical medications has yet to be assessed. METHODS Data was collected from 128 participants in an IRB randomized, controlled trial. To a marked 3cmx8cm rectangle on the forearm, patients applied petroleum jelly from either a large container or a small tube. Pre and post application container weights were measured. RESULTS Patients applied more topical medication from the large container compared to the small tube. CONCLUSION Topical medication usage is influenced by the size of the container provided. It is beneficial to consider container size when prescribing topical medications and greater application is desired.",2020,"RESULTS Patients applied more topical medication from the large container compared to the small tube. ","['Data was collected from 128 participants in an IRB randomized, controlled trial']",[],[],"[{'cui': 'C0086911', 'cui_str': 'Ethics Committee, Research'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0008976', 'cui_str': 'Clinical trial'}]",[],[],128.0,0.0273214,"RESULTS Patients applied more topical medication from the large container compared to the small tube. ","[{'ForeName': 'Brittany', 'Initials': 'B', 'LastName': 'Feaster', 'Affiliation': ''}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Aung-Din', 'Affiliation': ''}, {'ForeName': 'Edward W', 'Initials': 'EW', 'LastName': 'Seger', 'Affiliation': ''}, {'ForeName': 'Emily L', 'Initials': 'EL', 'LastName': 'Unrue', 'Affiliation': ''}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Devine', 'Affiliation': ''}, {'ForeName': 'Abigail', 'Initials': 'A', 'LastName': 'Cline', 'Affiliation': ''}, {'ForeName': 'Steven R', 'Initials': 'SR', 'LastName': 'Feldman', 'Affiliation': 'Center for Dermatology Research, Department of Dermatology, Wake Forest School of Medicine, Winston-Salem, NC Department of Pathology, Wake Forest School of Medicine, Winston-Salem, NC Department of Social Sciences & Health Policy, Wake Forest School of Medicine, Winston-Salem, NC Department of Dermatology, University of Southern Denmark, Odense. sfeldman@wakehealth.edu.'}]",Dermatology online journal,[] 2990,32621729,A mixed-method randomized feasibility trial evaluating progressive muscle relaxation or autogenic training on depressive symptoms and quality of life in people living with human immunodeficiency virus (HIV) who have depressive symptoms.,"Background Progressive muscle relaxation (PMR) and autogenic training (AT) are effective relaxation techniques to reduce depressive symptoms. However, no studies on their effectiveness have been conducted among people living with HIV and depressive symptoms. The primary aim of this pilot study was to assess the feasibility and acceptability of PMR and AT interventions among people living with HIV who have depressive symptoms. A secondary aim was to assess the potential effectiveness of these interventions on depressive symptoms and quality of life. Methods This study was a three-arm pilot randomized control trial with mixed methods. Participants were randomized to PMR, AT, or a control group (CG), with four assessments (baseline, and at one, three, and six months). The PMR and AT interventions consisted of six 1 h sessions of individual training over 12 weeks, plus home practice. Recruitment, attrition, and completion rates were calculated. Depressive symptoms and quality of life were assessed at all times. Participants' perceptions of the interventions were collected in semi-structured interviews. Results Following the screening, 54/63 people met the inclusion criteria, and 42/54 were randomly allocated to the PMR group (n=14), AT group (n=14), and CG (n=14). Six participants (43%; 95% CI 18-71%) in the PMR group and 10 (71%; 95% CI 42-92%) in the AT group completed the intervention. Participants reported better emotion management and improvements in depressive symptoms and quality of life. Conclusions The pilot study suggests that a randomized trial to test the effectiveness of these interventions is feasible. Trial registration ClinicalTrials.gov NCT01901016.",2020,Participants reported better emotion management and improvements in depressive symptoms and quality of life.,"['54/63 people met the inclusion criteria, and 42/54', 'people living with HIV and depressive symptoms', 'people living with human immunodeficiency virus (HIV) who have depressive symptoms', 'people living with HIV who have depressive symptoms']","['PMR', 'PMR and AT interventions', 'progressive muscle relaxation or autogenic training', ' Progressive muscle relaxation (PMR) and autogenic training (AT']","['depressive symptoms and quality of life', 'Depressive symptoms and quality of life', 'Recruitment, attrition, and completion rates', 'emotion management']","[{'cui': 'C0027361', 'cui_str': 'Person'}, {'cui': 'C0025646', 'cui_str': 'Methionine'}, {'cui': 'C0007637', 'cui_str': 'Cellular Inclusions'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0595998', 'cui_str': 'Household composition'}, {'cui': 'C0019682', 'cui_str': 'Human immunodeficiency virus'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}]","[{'cui': 'C0454043', 'cui_str': 'Jacobson technique'}, {'cui': 'C0004361', 'cui_str': 'Autogenic therapy'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}]","[{'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0518214', 'cui_str': 'Quality of life satisfaction'}, {'cui': 'C0031221', 'cui_str': 'Personnel Recruitment'}, {'cui': 'C0004277', 'cui_str': 'Dental Attrition'}, {'cui': 'C0205197', 'cui_str': 'Complete'}, {'cui': 'C0013987', 'cui_str': 'Emotion'}, {'cui': 'C0001554', 'cui_str': 'Administration'}]",,0.177044,Participants reported better emotion management and improvements in depressive symptoms and quality of life.,"[{'ForeName': 'Maria Pilar', 'Initials': 'MP', 'LastName': 'Ramirez-Garcia', 'Affiliation': 'Faculty of Nursing, Université de Montréal, Montréal, Quebec, Canada.'}, {'ForeName': 'Jérôme', 'Initials': 'J', 'LastName': 'Leclerc-Loiselle', 'Affiliation': 'Faculté des sciences infirmières, Université de Montréal, Montréal, Quebec, Canada.'}, {'ForeName': 'Marie-Pierre', 'Initials': 'MP', 'LastName': 'Gagnon', 'Affiliation': ""Faculté des Sciences Infirmières de l'Université Laval, Quebec, Canada.""}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Côté', 'Affiliation': 'Faculté des sciences infirmières, Université de Montréal, Montréal, Quebec, Canada.'}, {'ForeName': 'Marie-Josée', 'Initials': 'MJ', 'LastName': 'Brouillette', 'Affiliation': 'Department of Psychiatry, McGill University, Montréal, Quebec, Canada.'}, {'ForeName': 'Réjean', 'Initials': 'R', 'LastName': 'Thomas', 'Affiliation': ""Clinique médicale l'Actuel, Montréal, Quebec, Canada.""}]",Journal of complementary & integrative medicine,['10.1515/jcim-2019-0167'] 2991,32621735,Expert advice about therapeutic exercise during pregnancy reduces the symptoms of sacroiliac dysfunction.,"Objectives There are growing evidence that exercise improves sacroiliac dysfunction symptoms in pregnant women; but no data about the effect of expert advice regarding this matter. The aim of this study was to assess the effectiveness of expert advice about therapeutic exercise on sacroiliac dysfunction in pregnancy. Methods A total of 500 women with sacroiliac dysfunction diagnosed in pregnancy were randomized in study and control group. Study group has conducted expert advice on therapeutic exercise; while control group continued with their normal lifestyle. Pain intensity by Visual Analog Scale (VAS) and degree of functional disability by Quebec scale were assessed at enrolment and after 3 and 6 weeks. Results Significantly better reduction in pain intensity assessed by VAS (p=0.001) and degree of functional disability assessed by Quebec scale (p=0.001) was noted in study compared to control group. Better results for both outcome measures were obtained if intervention was implemented earlier i.e., in second (p=0.001; p=0.001) compared to third (p=0.005; p=0.001) trimester. Strong positive correlation was found between pain intensity and degree of functional disability in both groups. Conclusions Expert advice on therapeutic exercise is effective in reduction of sacroiliac dysfunction symptoms during pregnancy. Trial registration ACTRN12617000556347.",2020,Results Significantly better reduction in pain intensity assessed by VAS (p=0.001) and degree of functional disability assessed by Quebec scale (p=0.001) was noted in study compared to control group.,"['sacroiliac dysfunction in pregnancy', '500 women with sacroiliac dysfunction diagnosed in pregnancy', 'pregnant women']","['expert advice about therapeutic exercise', 'exercise']","['degree of functional disability assessed by Quebec scale', 'Pain intensity by Visual Analog Scale (VAS) and degree of functional disability by Quebec scale', 'sacroiliac dysfunction symptoms', 'pain intensity assessed by VAS', 'pain intensity and degree of functional disability']","[{'cui': 'C0555898', 'cui_str': 'Sacroiliac'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0032961', 'cui_str': 'Pregnancy'}, {'cui': 'C3816747', 'cui_str': '500'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C0011900', 'cui_str': 'Diagnosis'}, {'cui': 'C0033011', 'cui_str': 'Pregnant woman'}]","[{'cui': 'C0150600', 'cui_str': 'Recommendation to'}, {'cui': 'C0452240', 'cui_str': 'Exercises'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}]","[{'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0205245', 'cui_str': 'Functional'}, {'cui': 'C0231170', 'cui_str': 'Disability'}, {'cui': 'C0034390', 'cui_str': 'Quebec'}, {'cui': 'C0175659', 'cui_str': 'Scale'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0555898', 'cui_str': 'Sacroiliac'}, {'cui': 'C0031847', 'cui_str': 'physiopathology'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",500.0,0.118531,Results Significantly better reduction in pain intensity assessed by VAS (p=0.001) and degree of functional disability assessed by Quebec scale (p=0.001) was noted in study compared to control group.,"[{'ForeName': 'Manuela', 'Initials': 'M', 'LastName': 'Filipec', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, Clinical hospital ""Sveti Duh"", Zagreb, Croatia.'}, {'ForeName': 'Ratko', 'Initials': 'R', 'LastName': 'Matijević', 'Affiliation': 'Department of Obstetrics and Gynecology, University of Zagreb, Zagreb, Croatia.'}]",Journal of perinatal medicine,['10.1515/jpm-2020-0143'] 2992,32621736,Effect of Oral Glucose Water Administration 1 Hour Preoperatively in Children with Cyanotic Congenital Heart Disease: A Randomized Controlled Trial.,"BACKGROUND Guidelines recommend a clear liquid fasting time of 2 h before surgery, which is often exceeded, leading to adverse reactions (ARs) such as discomfort, thirst, and dehydration. We assessed the gastric contents and ARs after oral glucose water administration 1 h prior to surgery in children with cyanotic congenital heart disease (CCHD). MATERIAL AND METHODS This was a non-inferiority randomized controlled trial of children with CCHD enrolled at the Fujian Medical University Union Hospital from 09/2014 to 05/2017 and randomized to receive oral glucose water (10 g of glucose in 100 ml of warm water, 5 ml/kg) 2 h (2-h group, n=174) or 1 h (1-h group, n=170) before surgery. The primary endpoint was gastric volume. Secondary endpoints included pH of gastric content, preoperative blood glucose, and risk factors for aspiration pneumonia. Pre- and intraoperative ARs were recorded. RESULTS The 1-h group showed smaller gastric content volumes (0.34±0.35 (95% CI: 0.29-0.39) vs. 0.43±0.33 (95% CI: 0.38-0.48) ml/kg, t=2.55, P<0.05) and higher blood glucose (6.21±0.78 (95% CI: 6.09-6.33) vs. 5.59±1.11 (95% CI: 5.43-5.76) mmol/L, t=-5.91, P<0.001). The 95% confidence interval of the volume difference between the 2 groups was 0.017-0.163, the upper limit value was 0.163  0.05). Group-US showed statistically significant reduction in T. forsythia at 1 week only (p < 0.05). Group-PDT showed statistically significant reduction in P. gingivalis and T. forsythia from baseline to 1 week and 4 weeks (p < 0.05). This was also significant when compared with US on both the time points (p < 0.05). CONCLUSION PDT was effective in significantly reducing periodontal pathogens in established gingivitis lesions in adolescent patients undergoing fixed orthodontic treatment in short term.",2020,Group-PDT showed statistically significant reduction in P. gingivalis and T. forsythia from baseline to 1 week and 4 weeks (p < 0.05).,"['adolescent patients undergoing fixed orthodontic treatment', '22 adolescent patients (mean age: 17.5 years) undergoing fixed orthodontic treatment and presenting with persistent local gingival inflammation', 'adolescent patients undergoing fixed orthodontic treatment in short term']","['photodynamic therapy (PDT', 'PDT', 'photodynamic therapy against periodontal bacteria', 'Group-US: patients receiving ultrasonic scaling (US) with usual oral hygiene instructions and Group-PDT', 'adjunctive PDT with US']","['P. gingivalis and T. forsythia', 'PS and BOP', 'periodontal pathogens', 'T. forsythia', 'plaque scores (PS) and bleeding on probing (BOP', 'total bacterial counts of P. gingivalis and T. forsythia']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0443218', 'cui_str': 'Fixed'}, {'cui': 'C0204193', 'cui_str': 'Orthodontic procedure'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0150312', 'cui_str': 'Present'}, {'cui': 'C0332996', 'cui_str': 'Persistent embryonic structure'}, {'cui': 'C0205276', 'cui_str': 'Local'}, {'cui': 'C0017574', 'cui_str': 'Gingivitis'}, {'cui': 'C0453933', 'cui_str': 'Shorts'}, {'cui': 'C0233324', 'cui_str': 'Term birth of newborn'}]","[{'cui': 'C0031740', 'cui_str': 'Photochemotherapy'}, {'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0004611', 'cui_str': 'Bacterium'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0204131', 'cui_str': 'Oral hygiene education'}]","[{'cui': 'C1018538', 'cui_str': 'Lian qiao'}, {'cui': 'C0011389', 'cui_str': 'Dental plaque'}, {'cui': 'C0449820', 'cui_str': 'Score'}, {'cui': 'C0019080', 'cui_str': 'Hemorrhage'}, {'cui': 'C0182400', 'cui_str': 'Probe'}, {'cui': 'C2960678', 'cui_str': 'Periodontal route'}, {'cui': 'C0450254', 'cui_str': 'Pathogenic organism'}, {'cui': 'C0439810', 'cui_str': 'Total'}, {'cui': 'C0004618', 'cui_str': 'Bacterial count'}]",22.0,0.027607,Group-PDT showed statistically significant reduction in P. gingivalis and T. forsythia from baseline to 1 week and 4 weeks (p < 0.05).,"[{'ForeName': 'Abdullah', 'Initials': 'A', 'LastName': 'Al Nazeh', 'Affiliation': 'Department of Orthodontics and Pedodontics, College of Dentistry, King Khalid University, Abha, Saudi Arabia.'}, {'ForeName': 'Abdul Aziz', 'Initials': 'AA', 'LastName': 'Alshahrani', 'Affiliation': 'Department of Orthodontics and Pedodontics, College of Dentistry, King Khalid University, Abha, Saudi Arabia.'}, {'ForeName': 'Salem', 'Initials': 'S', 'LastName': 'Almoammar', 'Affiliation': 'Department of Orthodontics and Pedodontics, College of Dentistry, King Khalid University, Abha, Saudi Arabia.'}, {'ForeName': 'Muhammad Abdullah', 'Initials': 'MA', 'LastName': 'Kamran', 'Affiliation': 'Department of Orthodontics and Pedodontics, College of Dentistry, King Khalid University, Abha, Saudi Arabia.'}, {'ForeName': 'Rafi A', 'Initials': 'RA', 'LastName': 'Togoo', 'Affiliation': 'Department of Orthodontics and Pedodontics, College of Dentistry, King Khalid University, Abha, Saudi Arabia.'}, {'ForeName': 'Ibrahim', 'Initials': 'I', 'LastName': 'Alshahrani', 'Affiliation': 'Department of Orthodontics and Pedodontics, College of Dentistry, King Khalid University, Abha, Saudi Arabia. Electronic address: ibrahimalshahranikku@gmail.com.'}]",Photodiagnosis and photodynamic therapy,['10.1016/j.pdpdt.2020.101904'] 2994,32622171,Change in core symptoms of borderline personality disorder by tDCS: A pilot study.,"Borderline personality disorder (BPD) recognizes several psychopathological dimensions related to prefrontal cortex impairments. Transcranial Direct Current Stimulation (tDCS) targeting the right prefrontal dorsolateral cortex (DLPFC) positively influence cognitive functions related to impulsivity in healthy subjects. A randomized double-blind study was designed to investigate whether tDCS could modulate core dimensions (impulsivity, aggression, affective dysregulation) of BPD. Also effects on decision making process and substances craving was assessed. Patients were randomized to receive active-tDCS at 2 mA versus sham-tDCS, once a day for 15 sessions. Anode was placed on the right DLPFC (F4), cathode on the left DLPFC (F3). Impulsivity and aggression measures were significantly reduced only in patients treated with active-tDCS. Decision-making process was marginally influenced by the active current. Craving intensity was reduced only in the active-tDCS sample. Both groups showed improvements in the affective dysregulation dimension and anxious and depressive symptoms. The application of bilateral tDCS targeting right DLPFC with anodal stimulation seems to improve core dimensions of BPD (mainly impulsivity and aggression) probably by restoring prefrontal activity. tDCS might be a potential tool for preventing self-harming behaviors.",2020,Both groups showed improvements in the affective dysregulation dimension and anxious and depressive symptoms.,['healthy subjects'],"['Transcranial Direct Current Stimulation (tDCS', 'active-tDCS at 2\xa0mA versus sham-tDCS', 'tDCS']","['Craving intensity', 'Impulsivity and aggression measures', 'decision making process and substances craving', 'affective dysregulation dimension and anxious and depressive symptoms', 'core dimensions (impulsivity, aggression, affective dysregulation) of BPD']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0205177', 'cui_str': 'Active'}, {'cui': 'C0073980', 'cui_str': 'salicylhydroxamic acid'}]","[{'cui': 'C0870371', 'cui_str': 'Craving'}, {'cui': 'C0522510', 'cui_str': 'With intensity'}, {'cui': 'C0021125', 'cui_str': 'Impulsive behaviour'}, {'cui': 'C0001807', 'cui_str': 'Aggressive behavior'}, {'cui': 'C0079809', 'cui_str': 'Measure'}, {'cui': 'C0011109', 'cui_str': 'Decision making'}, {'cui': 'C1522240', 'cui_str': 'Process'}, {'cui': 'C0439861', 'cui_str': 'Substance'}, {'cui': 'C0439534', 'cui_str': 'Dimensions'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0086132', 'cui_str': 'Symptoms of depression'}, {'cui': 'C0444669', 'cui_str': 'Core'}, {'cui': 'C0006012', 'cui_str': 'Borderline personality disorder'}]",,0.0377358,Both groups showed improvements in the affective dysregulation dimension and anxious and depressive symptoms.,"[{'ForeName': 'Jacopo', 'Initials': 'J', 'LastName': 'Lisoni', 'Affiliation': 'Department of Mental Health and Addiction Services, ASST Spedali Civili, Brescia, Italy Piazzale Spedali Civili 1, 25123, Brescia Italy. Electronic address: jacopo.lisoni@gmail.com.'}, {'ForeName': 'Paola', 'Initials': 'P', 'LastName': 'Miotto', 'Affiliation': 'Department of Mental Health and Addiction Services, ASST Spedali Civili, Brescia, Italy Piazzale Spedali Civili 1, 25123, Brescia Italy. Electronic address: miottopaola@yahoo.it.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Barlati', 'Affiliation': 'Department of Mental Health and Addiction Services, ASST Spedali Civili, Brescia, Italy Piazzale Spedali Civili 1, 25123, Brescia Italy; Department of Clinical and Experimental Sciences, University of Brescia, Brescia, Italy. Viale Europa 11, 25123, Brescia Italy. Electronic address: stefano.barlati@unibs.it.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Calza', 'Affiliation': 'Department of Molecular and Translational Medicine, University of Brescia, Brescia, Italy. Viale Europa 11, 25123, Brescia Italy. Electronic address: stefano.calza@unibs.it.'}, {'ForeName': 'Alessandra', 'Initials': 'A', 'LastName': 'Crescini', 'Affiliation': 'Department of Mental Health, ASST Valcamonica, Esine, Italy. Via Manzoni 142, Esine, Brescia ITALY.'}, {'ForeName': 'Giacomo', 'Initials': 'G', 'LastName': 'Deste', 'Affiliation': 'Department of Mental Health and Addiction Services, ASST Spedali Civili, Brescia, Italy Piazzale Spedali Civili 1, 25123, Brescia Italy. Electronic address: giacomodeste@mac.com.'}, {'ForeName': 'Emilio', 'Initials': 'E', 'LastName': 'Sacchetti', 'Affiliation': 'Department of Clinical and Experimental Sciences, University of Brescia, Brescia, Italy. Viale Europa 11, 25123, Brescia Italy. Electronic address: emilio.sacchetti@unibs.it.'}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Vita', 'Affiliation': 'Department of Mental Health and Addiction Services, ASST Spedali Civili, Brescia, Italy Piazzale Spedali Civili 1, 25123, Brescia Italy; Department of Clinical and Experimental Sciences, University of Brescia, Brescia, Italy. Viale Europa 11, 25123, Brescia Italy. Electronic address: antonio.vita@unibs.it.'}]",Psychiatry research,['10.1016/j.psychres.2020.113261'] 2995,32622225,The impact of adult trauma triage training on decision-making skills and accuracy of triage decision at emergency departments in Malaysia: A randomized control trial.,"INTRODUCTION Patients who visit emergency departments need to undergo a precise assessment to determine their priority and accurate triage category to ensure they receive the right treatment. AIM To identify the effect of triage training on the skills and accuracy of triage decisions for adult trauma patients. METHOD A randomized controlled trial design was conducted in ten emergency department of public hospitals. A total of 143 registered nurses and medical officer assistants who performed triage roles were recruited for the control group (n = 74) and the intervention group (n = 69). The skill and accuracy of triage decisions were measured two weeks and four weeks after the intervention group were exposed to the intervention. RESULTS There was a significant effect on the skill of triage decision-making between the control and the intervention group p < 0.001, η 2 partial  = 0.31. Concerning the accuracy of triage decisions, the effect was significantly different between the control group and the intervention group p < 0.001, η 2 partial  = 0.66 across time. CONCLUSION The triage training improved the skills of the participants and the accuracy of triage decision-making across time.",2020,"There was a significant effect on the skill of triage decision-making between the control and the intervention group p < 0.001, η 2 partial  = 0.31.","['emergency departments in Malaysia', 'Patients who visit emergency departments', 'ten emergency department of public hospitals', '143 registered nurses and medical officer assistants who performed triage roles were recruited for the control group (n\xa0=\xa074) and the intervention group (n\xa0=\xa069', 'adult trauma patients']","['triage training', 'adult trauma triage training']","['skill and accuracy of triage decisions', 'skill of triage decision-making']","[{'cui': 'C0562508', 'cui_str': 'Accident and Emergency department'}, {'cui': 'C0024552', 'cui_str': 'Malaysia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0020022', 'cui_str': 'Public Hospitals'}, {'cui': 'C4517573', 'cui_str': '143'}, {'cui': 'C0687673', 'cui_str': 'Registered nurse'}, {'cui': 'C0557516', 'cui_str': 'Medical officer'}, {'cui': 'C0011327', 'cui_str': 'Dental assistant'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0040861', 'cui_str': 'Triage'}, {'cui': 'C0035820', 'cui_str': 'Role'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}]","[{'cui': 'C0040861', 'cui_str': 'Triage'}, {'cui': 'C0040607', 'cui_str': 'Training Programs'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0043251', 'cui_str': 'Injuries, Wounds'}]","[{'cui': 'C0443131', 'cui_str': 'Accurate'}, {'cui': 'C0040861', 'cui_str': 'Triage'}, {'cui': 'C0011109', 'cui_str': 'Decision making'}]",143.0,0.0515258,"There was a significant effect on the skill of triage decision-making between the control and the intervention group p < 0.001, η 2 partial  = 0.31.","[{'ForeName': 'Siti Aishah', 'Initials': 'SA', 'LastName': 'Ghazali', 'Affiliation': 'School of Health Sciences, Health Campus, Universiti Sains Malaysia, Kelantan, Malaysia; Department of Nursing Science, Faculty of Medicine, University of Malaya, 50603 Kuala Lumpur, Malaysia. Electronic address: schah@usm.my.'}, {'ForeName': 'Khatijah Lim', 'Initials': 'KL', 'LastName': 'Abdullah', 'Affiliation': 'Department of Nursing Science, Faculty of Medicine, University of Malaya, 50603 Kuala Lumpur, Malaysia. Electronic address: katlim@um.edu.my.'}, {'ForeName': 'Foong Ming', 'Initials': 'FM', 'LastName': 'Moy', 'Affiliation': 'Department of Social and Preventive Medicine, Faculty of Medicine, University of Malaya, 50603 Kuala Lumpur, Malaysia. Electronic address: moyfm@ummc.edu.my.'}, {'ForeName': 'Rashidi', 'Initials': 'R', 'LastName': 'Ahmad', 'Affiliation': 'Department of Emergency Medicine, University of Malaya, 50603 Kuala Lumpur, Malaysia. Electronic address: rashidi@ummc.edu.my.'}, {'ForeName': 'Emni Omar Daw', 'Initials': 'EOD', 'LastName': 'Hussin', 'Affiliation': 'Department of Nursing Science, Faculty of Medicine, University of Malaya, 50603 Kuala Lumpur, Malaysia.'}]",International emergency nursing,['10.1016/j.ienj.2020.100889'] 2996,32622294,The effects of yoga on functionality appreciation and additional facets of positive body image.,"This study investigated the effects of yoga on functionality appreciation, and the potential mechanisms that could explain the impact of yoga on additional facets of positive body image. Young adult women (N = 114; M age  = 22.19) were randomised to a 10-week Hatha yoga programme or waitlist control group. Participants completed measures of functionality appreciation, body appreciation, body compassion, appearance evaluation, self-objectification, and embodiment at Pretest, Midtest, Posttest, and 1-month Follow-Up. Follow-up data could not be analysed due to high levels of attrition. The remaining data showed that, compared to the control group, women in the yoga programme experienced lower self-objectification at Midtest and greater embodiment over time. Further, all participants experienced improvements in body appreciation, body compassion, and appearance evaluation over time, regardless of their assigned group. Lower self-objectification contributed to improvements in body appreciation and body compassion. In addition, greater embodiment contributed to improvements in body appreciation, body compassion, and appearance evaluation. Contrary to our expectations, yoga did not lead to increased functionality appreciation, nor was functionality appreciation a mediator of the impact of yoga on positive body image. Instead, lower self-objectification, and greater embodiment, drove improvements in positive body image.",2020,"The remaining data showed that, compared to the control group, women in the yoga programme experienced lower self-objectification at Midtest and greater embodiment over time.",['Young adult women (N\u202f=\u202f114; M age \u202f=\u202f22.19'],['Hatha yoga programme or waitlist control group'],"['body appreciation and body compassion', 'functionality appreciation, body appreciation, body compassion, appearance evaluation, self-objectification, and embodiment at Pretest, Midtest, Posttest, and 1-month Follow-Up', 'body appreciation, body compassion, and appearance evaluation']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C0043210', 'cui_str': 'Woman'}, {'cui': 'C4708785', 'cui_str': '114'}, {'cui': 'C0001779', 'cui_str': 'Age'}]","[{'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0152338', 'cui_str': 'Structure of body of caudate nucleus'}, {'cui': 'C0242270', 'cui_str': 'Compassion'}, {'cui': 'C0700364', 'cui_str': 'Appearance'}, {'cui': 'C0846574', 'cui_str': 'Psychiatric evaluation'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0332177', 'cui_str': 'Monthly'}, {'cui': 'C0589120', 'cui_str': 'Follow-up status'}]",,0.0268438,"The remaining data showed that, compared to the control group, women in the yoga programme experienced lower self-objectification at Midtest and greater embodiment over time.","[{'ForeName': 'Jessica M', 'Initials': 'JM', 'LastName': 'Alleva', 'Affiliation': 'Department of Clinical Psychological Science, Maastricht University, Maastricht, the Netherlands. Electronic address: Jessica.Alleva@maastrichtuniversity.nl.'}, {'ForeName': 'Tracy L', 'Initials': 'TL', 'LastName': 'Tylka', 'Affiliation': 'Department of Psychology, The Ohio State University, Columbus, OH, United States.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'van Oorsouw', 'Affiliation': 'Department of Clinical Psychological Science, Maastricht University, Maastricht, the Netherlands.'}, {'ForeName': 'Erika', 'Initials': 'E', 'LastName': 'Montanaro', 'Affiliation': 'Department of Psychology, The University of North Carolina at Charlotte, Charlotte, NC, United States.'}, {'ForeName': 'Iris', 'Initials': 'I', 'LastName': 'Perey', 'Affiliation': 'Chair of Sport and Health Management, Technical University of Munich, Germany.'}, {'ForeName': 'Cheyenne', 'Initials': 'C', 'LastName': 'Bolle', 'Affiliation': 'Department of Clinical Psychological Science, Maastricht University, Maastricht, the Netherlands.'}, {'ForeName': 'Jantine', 'Initials': 'J', 'LastName': 'Boselie', 'Affiliation': 'Department of Clinical Psychological Science, Maastricht University, Maastricht, the Netherlands.'}, {'ForeName': 'Madelon', 'Initials': 'M', 'LastName': 'Peters', 'Affiliation': 'Department of Clinical Psychological Science, Maastricht University, Maastricht, the Netherlands.'}, {'ForeName': 'Jennifer B', 'Initials': 'JB', 'LastName': 'Webb', 'Affiliation': 'Department of Psychology, The University of North Carolina at Charlotte, Charlotte, NC, United States.'}]",Body image,['10.1016/j.bodyim.2020.06.003'] 2997,32621555,"The long-term effectiveness of universal, selective and combined prevention for alcohol use during adolescence: 36-month outcomes from a cluster randomized controlled trial.","AIM To compare the long-term universal outcomes of the Climate Schools program, the selective Preventure program and their combined implementation to standard substance use education in reducing the uptake of alcohol use, engagement in binge drinking and alcohol-related harms over a 3-year period. DESIGN A cluster randomized controlled trial. SETTING Substance use prevention programs delivered in Australian secondary schools. PARTICIPANTS Students from 26 Australian secondary schools (n = 2,190), mean age at baseline 13.3 years (SD 0.48), 57.4% male. Schools were recruited between September 2011 and February 2012. INTERVENTIONS Schools were block randomized to one of four groups; universal prevention (Climate;12 x 40min lessons); selective prevention (Preventure; 2 x 90min sessions); combined prevention (Climate and Preventure; CAP); or health education as usual (Control). The Climate intervention delivered 12 x 40-minute lessons aimed at reducing alcohol and cannabis use and related harms. The Preventure intervention delivered 2 x 90-minute group sessions to high-risk students. The CAP group implemented the Climate program to the entire year group and the Preventure program to the high-risk students. MEASUREMENTS Participants were all consenting 8 th grade students (in 2012) assessed at baseline, post intervention (6-9 months post baseline), and at 12, 24 and 36 months post baseline, on measures of alcohol use, knowledge and related harms. Primary outcomes were alcohol use, binge drinking (5+ standard drinks) and alcohol-related harms, obtained from all students regardless of whether or not they received intervention. Intervention effects at 36 months post-baseline were estimated from generalized multilevel mixed models using data from all timepoints and accounting for school level clustering. Exploratory analyses examined intervention effects among low- and high-risk adolescents. FINDINGS Compared with students in the Control condition, students in the Climate, Preventure and CAP groups demonstrated significantly slower increases in their likelihood to drink any alcohol (OR=0.64, 95%CI=0.50-0.82 for Climate; OR=0.55, 95%CI=0.43-0.71 for Preventure and OR=0.67, 95%CI=0.53-0.84 for CAP), to engage in binge drinking (OR=0.60, 95%CI=0.44-0.82 for Climate; OR=0.59, 95%CI=0.44-0.80 for Preventure and OR=0.68, 95%CI=0.51-0.92 for CAP), and to experience alcohol harms (OR=0.63, 95%CI=0.49-0.82 for Climate; OR=0.55, 95%CI=0.43-0.71 for Preventure and OR=0.64, 95%CI=0.50-0.81 for CAP). There was no strong evidence that the combined approach showed advantages over universal prevention. The direction and magnitude of effects were consistent in low- and high-risk adolescents. CONCLUSIONS The universal Climate Schools program and the selective Preventure program were effective in reducing alcohol consumption and alcohol problems compared with standard Australian health education, when trialled individually and together over a 3-year period.",2020,"The universal Climate Schools program and the selective Preventure program were effective in reducing alcohol consumption and alcohol problems compared with standard Australian health education, when trialled individually and together over a 3-year period.","['Substance use prevention programs delivered in Australian secondary schools', 'Schools were recruited between September 2011 and February 2012', 'Students from 26 Australian secondary schools (n = 2,190), mean age at baseline 13.3 years (SD 0.48), 57.4% male']","['universal prevention (Climate;12 x 40min lessons); selective prevention (Preventure; 2 x 90min sessions); combined prevention (Climate and Preventure; CAP); or health education as usual (Control', 'universal, selective and combined prevention']","['likelihood to drink any alcohol', 'alcohol use, binge drinking (5+ standard drinks) and alcohol-related harms', 'engage in binge drinking', 'alcohol consumption and alcohol problems']","[{'cui': 'C0150358', 'cui_str': 'Substance use prevention'}, {'cui': 'C0018106', 'cui_str': 'Government Programs'}, {'cui': 'C0036530', 'cui_str': 'Secondary school'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0038492', 'cui_str': 'Student'}, {'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0168634', 'cui_str': 'BaseLine dental cement'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C4517461', 'cui_str': '0.48'}, {'cui': 'C0086582', 'cui_str': 'Male'}]","[{'cui': 'C0175671', 'cui_str': 'Universal'}, {'cui': 'C0199176', 'cui_str': 'Preventive procedure'}, {'cui': 'C0008946', 'cui_str': 'Climate'}, {'cui': 'C0006935', 'cui_str': 'Capsule'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0452428', 'cui_str': 'Drink'}, {'cui': 'C0001962', 'cui_str': 'Ethanol'}, {'cui': 'C0001948', 'cui_str': 'Alcohol intake'}, {'cui': 'C0556346', 'cui_str': 'Drinking binge'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C0549393', 'cui_str': 'Alcohol problem'}]",2190.0,0.113799,"The universal Climate Schools program and the selective Preventure program were effective in reducing alcohol consumption and alcohol problems compared with standard Australian health education, when trialled individually and together over a 3-year period.","[{'ForeName': 'Tim', 'Initials': 'T', 'LastName': 'Slade', 'Affiliation': 'The Matilda Centre for Research in Mental Health and Substance Use, University of Sydney, Sydney, Australia.'}, {'ForeName': 'Nicola C', 'Initials': 'NC', 'LastName': 'Newton', 'Affiliation': 'The Matilda Centre for Research in Mental Health and Substance Use, University of Sydney, Sydney, Australia.'}, {'ForeName': 'Marius', 'Initials': 'M', 'LastName': 'Mather', 'Affiliation': 'The Matilda Centre for Research in Mental Health and Substance Use, University of Sydney, Sydney, Australia.'}, {'ForeName': 'Emma L', 'Initials': 'EL', 'LastName': 'Barrett', 'Affiliation': 'The Matilda Centre for Research in Mental Health and Substance Use, University of Sydney, Sydney, Australia.'}, {'ForeName': 'Katrina E', 'Initials': 'KE', 'LastName': 'Champion', 'Affiliation': 'The Matilda Centre for Research in Mental Health and Substance Use, University of Sydney, Sydney, Australia.'}, {'ForeName': 'Lexine', 'Initials': 'L', 'LastName': 'Stapinski', 'Affiliation': 'The Matilda Centre for Research in Mental Health and Substance Use, University of Sydney, Sydney, Australia.'}, {'ForeName': 'Patricia J', 'Initials': 'PJ', 'LastName': 'Conrod', 'Affiliation': 'Department of Psychiatry, Université de Montréal, Montreal, Quebec, Canada.'}, {'ForeName': 'Maree', 'Initials': 'M', 'LastName': 'Teesson', 'Affiliation': 'The Matilda Centre for Research in Mental Health and Substance Use, University of Sydney, Sydney, Australia.'}]","Addiction (Abingdon, England)",['10.1111/add.15178'] 2998,32621557,Association Between HbA 1c Levels and Cardiovascular Outcomes in Patients With Type 2 Diabetes and Cardiovascular Disease: A Secondary Analysis of the TECOS Randomized Clinical Trial.,"AIMS Whether glycemic control is associated with cardiovascular outcomes in patients with type 2 diabetes (T2D) is unclear. Consequently, we assessed the relationship between glycated hemoglobin (HbA 1c ) and cardiovascular outcomes in a placebo-controlled randomized trial which demonstrated no cardiovascular effect of sitagliptin in patients with T2D and atherosclerotic vascular disease. METHODS AND RESULTS Secondary analysis of 14,656 TECOS participants with time to event analyses using multivariable Cox proportional hazard models. During a median 3.0 (IQR 2.3-3.8) year follow-up, 456 (3.1% of 14,656) patients had first hospitalization for heart failure (HF), 1084 (11.5%) died, 1406 (9.6%) died or were hospitalized for HF, and 1689 (11.5%) had a non-HF cardiovascular event (cardiovascular death, nonfatal stroke, nonfatal myocardial infarction, or hospitalization for unstable angina). Associations between baseline or time-varying HbA 1c and cardiovascular outcomes were U-shaped, with the lowest risk when HbA 1c was around 7%. Each one-unit increase in the time-varying HbA 1c above 7% was associated with an adjusted HR of 1.21 (95%CI 1.11-1.33) for first HF hospitalization, 1.11 (1.03-1.21) for all-cause death, 1.18 (1.09-1.26) for death or HF hospitalization, and 1.10 (1.02-1.17) for non-HF cardiovascular events. Each one-unit decrease in the time-varying HbA 1c below 7% was associated with an adjusted HR of 1.35 (95% CI 1.12-1.64) for first HF hospitalization, 1.37 (1.16-1.61) for death, 1.42 (1.23- 1.64) for death or HF hospitalization, and 1.22 (95% CI 1.06-1.41) for non-HF cardiovascular events. CONCLUSION HbA 1c exhibits a U-shaped association with cardiovascular outcomes in patients with T2D and atherosclerotic vascular disease, with nadir around 7%. This article is protected by copyright. All rights reserved.",2020,"HbA 1c exhibits a U-shaped association with cardiovascular outcomes in patients with T2D and atherosclerotic vascular disease, with nadir around 7%.","['patients with T2D and atherosclerotic vascular disease', 'patients with type 2 diabetes (T2D', 'Patients With Type 2 Diabetes and Cardiovascular Disease', 'Secondary analysis of 14,656 TECOS participants with time to event analyses using multivariable Cox proportional hazard models', 'patients with T2D and atherosclerotic vascular disease, with nadir around 7']",['sitagliptin'],"['time-varying HbA 1c and cardiovascular outcomes', 'first hospitalization for heart failure (HF', 'glycated hemoglobin (HbA 1c ) and cardiovascular outcomes', 'Cardiovascular Outcomes', 'death or HF hospitalization', 'non-HF cardiovascular event (cardiovascular death, nonfatal stroke, nonfatal myocardial infarction, or hospitalization for unstable angina', 'time-varying HbA 1c']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0004153', 'cui_str': 'Atherosclerosis'}, {'cui': 'C0441730', 'cui_str': 'Type 2'}, {'cui': 'C0007222', 'cui_str': 'Disorder of cardiovascular system'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}, {'cui': 'C0002778', 'cui_str': 'Analysis'}, {'cui': 'C0332311', 'cui_str': 'With time'}, {'cui': 'C0441471', 'cui_str': 'Event'}, {'cui': 'C0010235', 'cui_str': 'Cox Proportional Hazards Models'}]","[{'cui': 'C1565750', 'cui_str': 'sitagliptin'}]","[{'cui': 'C0040223', 'cui_str': 'Time'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0007226', 'cui_str': 'Structure of cardiovascular system'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C0019993', 'cui_str': 'Inpatient care'}, {'cui': 'C0018801', 'cui_str': 'Heart failure'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0038454', 'cui_str': 'Cerebrovascular accident'}, {'cui': 'C0027051', 'cui_str': 'Myocardial infarction'}, {'cui': 'C0002965', 'cui_str': 'Impending infarction'}]",14656.0,0.0828028,"HbA 1c exhibits a U-shaped association with cardiovascular outcomes in patients with T2D and atherosclerotic vascular disease, with nadir around 7%.","[{'ForeName': 'Finlay A', 'Initials': 'FA', 'LastName': 'McAlister', 'Affiliation': 'Faculty of Medicine and Dentistry, University of Alberta, Edmonton, Canada.'}, {'ForeName': 'Yinggan', 'Initials': 'Y', 'LastName': 'Zheng', 'Affiliation': 'Canadian VIGOUR Centre, University of Alberta, Edmonton, Canada.'}, {'ForeName': 'Cynthia M', 'Initials': 'CM', 'LastName': 'Westerhout', 'Affiliation': 'Canadian VIGOUR Centre, University of Alberta, Edmonton, Canada.'}, {'ForeName': 'John B', 'Initials': 'JB', 'LastName': 'Buse', 'Affiliation': 'Division of Endocrinology, University of North Carolina School of Medicine, Chapel Hill, North Carolina.'}, {'ForeName': 'Eberhard', 'Initials': 'E', 'LastName': 'Standl', 'Affiliation': 'Diabetes Research Group, Munich Helmholtz Center, Munich, Germany.'}, {'ForeName': 'Darren K', 'Initials': 'DK', 'LastName': 'McGuire', 'Affiliation': 'Division of Cardiology, University of Texas Southwestern Medical Center, Dallas, Texas.'}, {'ForeName': 'Frans', 'Initials': 'F', 'LastName': 'Van de Werf', 'Affiliation': 'Department of Cardiovascular Sciences, University of Leuven, Leuven, Belgium.'}, {'ForeName': 'Jennifer B', 'Initials': 'JB', 'LastName': 'Green', 'Affiliation': 'Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina.'}, {'ForeName': 'Paul W', 'Initials': 'PW', 'LastName': 'Armstrong', 'Affiliation': 'Canadian VIGOUR Centre, University of Alberta, Edmonton, Canada.'}, {'ForeName': 'Rury R', 'Initials': 'RR', 'LastName': 'Holman', 'Affiliation': 'Diabetes Trials Unit, University of Oxford, Oxford, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",European journal of heart failure,['10.1002/ejhf.1958'] 2999,32619204,"Optimized Curcumin, Pomegranate Extract, and Methylsulfonylmethane Reduce Acute, Systemic Inflammatory Response to a Half-marathon Race.","Context Endurance running places substantial physiological strain on the body, which can develop into chronic inflammation and overuse injuries, negatively affecting subsequent training and performance. A recent study found that dietary polyphenols and methlysulfonylmethane (MSM) can reduce systemic inflammation and oxidative stress without adverse side effects. Objective The purpose was to identify a set of candidate protein and RNA biomarkers that are associated with improved outcomes related to inflammation and muscle injury, when athletes used 3 proprietary supplements both prior to and during early recovery from a half-marathon race. Design The study was an open-label pilot study. Setting The study was field based, with sample analysis conducted in the Applied Physiology Laboratory in the Department of Kinesiology, Health Promotion and Recreation at the University of North Texas in Denton, Texas. Participants Participants were 15 young, exercise-trained men and women. Intervention The intervention group consumed 1000 mg/d of a proprietary 50-50 mix of optimized curcumin and pomegranate extract for 26 days. The group also consumed 500 mg/d of a proprietary MSM for the same period. Three days prior to and one day after a race, the daily dosage was doubled. The control group received no supplements. Outcome Measures Venous blood samples were collected at pre-race and at 4h and 24h after running a half-marathon race. The research team evaluated results for target proteins that have been associated with inflammation and muscle injury in the scientific literature. The team also performed an analysis of RNA biomarkers. Results At the 4h and 24h time points, a significant treatment-response was observed that included increases in proteins: (1) osteonectin/SPARC-osteonectin/secreted protein acidic and rich in cysteine and (2) BDNF-brain-derived neurotrophic factor. At the same points, the study also found increased RNA: (1) PACER-P50-associated COX-2 extragenic RNA, (2) PTGES-prostaglandin E synthase, (3) MYD88-innate immune signal transduction adaptor MYD88, (4) TNFS14-tumor necrosis factor (TNF) superfamily member 14, (5) THRIL-TNF and heterogeneous nuclear ribonucleoprotein L (HNRNPL)-related immunoregulatory long noncoding RNA, (6) TRAF6-TNF receptor associated factor 6, (7) CX3CL1-C-X3-C motif chemokine ligand 1, (8) MALAT1-metastasis-associated lung adenocarcinoma transcript 1, and (9) LINC00305-long intergenic nonprotein coding RNA 305. Conclusions The combination of polyphenol and MSM supplementation resulted in a systemic response that may translate to an accelerated rate of muscle recovery, allowing participants return to exercise and normal activities more quickly. This pilot study is the foundation for a larger investigation in the research team's laboratory.",2020,"The combination of polyphenol and MSM supplementation resulted in a systemic response that may translate to an accelerated rate of muscle recovery, allowing participants return to exercise and normal activities more quickly.","['sample analysis conducted in the Applied Physiology Laboratory in the Department of Kinesiology, Health Promotion and Recreation at the University of North Texas in Denton, Texas', 'Participants\n\n\nParticipants were 15 young, exercise-trained men and women']","['no supplements', 'dietary polyphenols and methlysulfonylmethane (MSM', 'polyphenol and MSM supplementation', 'intervention group consumed 1000 mg/d of a proprietary 50-50 mix of optimized curcumin and pomegranate extract']","['RNA', 'Venous blood samples', 'proteins: (1) osteonectin/SPARC-osteonectin/secreted protein acidic and rich in cysteine and (2']","[{'cui': 'C1303103', 'cui_str': 'Sample analysis'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C0031842', 'cui_str': 'Physiology'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0018738', 'cui_str': 'Health promotion'}, {'cui': 'C0034872', 'cui_str': 'Recreation'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0039711', 'cui_str': 'Texas'}, {'cui': 'C0332239', 'cui_str': 'Young'}, {'cui': 'C0015259', 'cui_str': 'Exercise'}, {'cui': 'C0336809', 'cui_str': 'Railway train'}, {'cui': 'C0025266', 'cui_str': 'Man'}, {'cui': 'C0043210', 'cui_str': 'Woman'}]","[{'cui': 'C0242295', 'cui_str': 'Nutrient supplementation'}, {'cui': 'C0012155', 'cui_str': 'Dietary finding'}, {'cui': 'C0071649', 'cui_str': 'Polyphenol'}, {'cui': 'C0058231', 'cui_str': 'methylsulfonylmethane'}, {'cui': 'C0242297', 'cui_str': 'Nutritional supplementation'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C1883310', 'cui_str': '1000'}, {'cui': 'C0439422', 'cui_str': 'mg/24h'}, {'cui': 'C0205430', 'cui_str': 'Mixed'}, {'cui': 'C0010467', 'cui_str': 'Curcumin'}, {'cui': 'C1961993', 'cui_str': 'Pomegranate Extract'}]","[{'cui': 'C0035668', 'cui_str': 'RNA'}, {'cui': 'C0444255', 'cui_str': 'Venous blood specimen'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0029446', 'cui_str': 'Osteonectin'}, {'cui': 'C0001128', 'cui_str': 'Acid'}, {'cui': 'C0699759', 'cui_str': 'Wealthy'}, {'cui': 'C0010654', 'cui_str': 'Cysteine'}]",15.0,0.057474,"The combination of polyphenol and MSM supplementation resulted in a systemic response that may translate to an accelerated rate of muscle recovery, allowing participants return to exercise and normal activities more quickly.","[{'ForeName': 'Elizabeth A', 'Initials': 'EA', 'LastName': 'Tanner', 'Affiliation': ''}, {'ForeName': 'Melody A', 'Initials': 'MA', 'LastName': 'Gary', 'Affiliation': ''}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Michalik', 'Affiliation': ''}, {'ForeName': 'Asheal A', 'Initials': 'AA', 'LastName': 'Davis', 'Affiliation': ''}, {'ForeName': 'Brian K', 'Initials': 'BK', 'LastName': 'McFarlin', 'Affiliation': ''}]",Alternative therapies in health and medicine,[] 3000,32619206,The Efficacy of Binaural Beats as a Stress-buffering Technique.,"Context Distress has deleterious effects on health. While complementary and alternative medicine (CAM) is a growing system of practices in the treatment of health and mental-health conditions, many individuals have limited access to mind-body interventions. Creating accessible stress-inoculation strategies may augment traditional mental-health interventions and services. Objective This pilot study intended to assess the effectiveness of a theta binaural beat (TBB) auditory stimulus on heart rate and self-reported stress, which was experimentally induced by the Trier Social Stress Test (TSST). Design The repeated measures study compared the stress levels after a stimulus and stressor for two groups, within an experimentally induced psychological stress paradigm, the Trier Social Stress Test (TSST). Setting The study occurred at a private Midwestern university. Participants Participants were 64 US adults recruited from undergraduate classes at the university, with a mean age of 19 years and a range from 18 to 30. Intervention Participants were randomly assigned to the intervention or the control group. The intervention group listened to pink sound, carrier tones, and embedded TBB, while the control group listened to pink sound and carrier tones without embedded TBB. Outcome Measures Participants completed self-report assessments about the auditory stimulus, perceived stress, and mindfulness and then engaged in the Trier Social Stress Test (TSST). Subsequently, they completed measures on perceived stress using a visual analogue scale (VAS), and heart rate variability (HRV) was recorded throughout the study. Results With respect to the evaluation of subjective stress using the VAS, psychological stress increased significantly between the exposure to the stimuli and the TSST-F(1.28, 53) = 42.76, P = .01, partial η2 = 0.44. The change in stress levels for the intervention group, however, was not significantly different from that of the control group at any time point F(1.28, 53) = 1.03, P = .33, partial η2 = 0.02. With respect to the evaluation of physiological response to stress using the HRV, the changes in HF HRV between the 4, five-minute segments during stimulus exposure were not significantly different between the groups F(3, 55) = 0.90, P = .44, partial η2 = 0.02. A significantly greater change-F(1, 55) = 4.84, P = .03 partial η2 = 0.08-in the HF HRV occurred over the TSST period for the intervention group compared to the control group suggesting that on average across the TSST stress tasks, those in the intervention group demonstrated higher HF signals. Conclusions The current study found that the intervention group, who listened to TBBs, had greater parasympathetic dominance during TSST than the control group. This suggests that TBB exposure may dampen subsequent stress responses to an acute, psychological stressor. This finding, however, should be interpreted with caution, because further research and independent replication are warranted.",2020,"A significantly greater change-F(1, 55) = 4.84, P = .03 partial η2 = 0.08-in","['Setting\n\n\nThe study occurred at a private Midwestern university', 'Participants\n\n\nParticipants were 64 US adults recruited from undergraduate classes at the university, with a mean age of 19 years and a range from 18 to 30']","['TSST', 'VAS', 'theta binaural beat (TBB) auditory stimulus', 'alternative medicine (CAM', 'intervention group listened to pink sound, carrier tones, and embedded TBB, while the control group listened to pink sound and carrier tones without embedded TBB']","['psychological stress paradigm, the Trier Social Stress Test (TSST', 'self-report assessments about the auditory stimulus, perceived stress, and mindfulness and then engaged in the Trier Social Stress Test (TSST', 'psychological stress', 'stress levels', 'HF HRV', 'parasympathetic dominance', 'higher HF signals', 'perceived stress using a visual analogue scale (VAS), and heart rate variability (HRV', 'heart rate and self-reported stress']","[{'cui': 'C0036849', 'cui_str': 'Set (Psychology)'}, {'cui': 'C0008972', 'cui_str': 'Clinical Study'}, {'cui': 'C2745955', 'cui_str': 'Occurrence'}, {'cui': 'C0033175', 'cui_str': 'Private Room'}, {'cui': 'C0041740', 'cui_str': 'University'}, {'cui': 'C0456387', 'cui_str': 'Class'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0002838', 'cui_str': 'Andorra'}]","[{'cui': 'C0065404', 'cui_str': 'lysyl-5-fluorotryptophyl-lysine'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}, {'cui': 'C0439101', 'cui_str': 'Theta'}, {'cui': 'C0178490', 'cui_str': 'Auditory stimulus'}, {'cui': 'C0002346', 'cui_str': 'Medicine, Alternative'}, {'cui': 'C0184661', 'cui_str': 'Procedure'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0004309', 'cui_str': 'Auditory Perception'}, {'cui': 'C0332585', 'cui_str': 'Pink color'}, {'cui': 'C0037709', 'cui_str': 'Sonic Radiation'}, {'cui': 'C0007294', 'cui_str': 'Genetic disorder carrier'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0038443', 'cui_str': 'Psychological Stress'}, {'cui': 'C0065404', 'cui_str': 'lysyl-5-fluorotryptophyl-lysine'}, {'cui': 'C0015260', 'cui_str': 'Exercise tolerance test'}, {'cui': 'C2700446', 'cui_str': 'Self-reported'}, {'cui': 'C0031809', 'cui_str': 'Physical examination'}, {'cui': 'C0178490', 'cui_str': 'Auditory stimulus'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married'}, {'cui': 'C1319127', 'cui_str': 'Level of stress'}, {'cui': 'C0018810', 'cui_str': 'Heart rate'}, {'cui': 'C1287621', 'cui_str': 'Eye dominance - finding'}, {'cui': 'C0205250', 'cui_str': 'High'}, {'cui': 'C0037083', 'cui_str': 'Signal transduction'}, {'cui': 'C0042815', 'cui_str': 'Visual analog pain scale'}]",64.0,0.0244326,"A significantly greater change-F(1, 55) = 4.84, P = .03 partial η2 = 0.08-in","[{'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Kelton', 'Affiliation': ''}, {'ForeName': 'Terri L', 'Initials': 'TL', 'LastName': 'Weaver', 'Affiliation': ''}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Willoughby', 'Affiliation': ''}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Kaufman', 'Affiliation': ''}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Santowski', 'Affiliation': ''}]",Alternative therapies in health and medicine,[] 3001,32621900,"Comparison of Toric Implantable Collamer Lens and Toric Artiflex Phakic IOLs in terms of Visual Outcome, A paired Contralateral Eye Study.","PURPOSE To compare the postoperative visual outcomes of toric implantable collamer lens (T-ICL) and toric Artiflex (T-Artiflex) implantation. DESIGN Alternating-treatment, contralateral eye matched clinical study METHODS: This study compared 82 eyes of 41 patients with toric ICL implantation in one eye and toric Artiflex implantation in the contralateral eye to correct myopic astigmatism. Safety, efficacy, predictability, astigmatic vector changes, contrast sensitivity, endothelial cell count, and possible adverse events were assessed at least 12 months postoperatively. RESULTS After a mean follow-up of 12 months, the safety index was 1.40±0.70 (mean ± SD) in T-ICL group and 1.20±0.21 in the T-Artiflex group. Further, their mean efficacy index was 1.24±0.42 and 1.08±0.23, respectively (p=0.029). Thirty nine (95%) eyes in the T- ICL group and 41(100%) eyes in the T-Artiflex group were within ±1.00 D of emmetropia and 33(80%) eyes and 34(83%) were within ±0.5D of emmetropia, respectively. Vector analysis revealed mean index of success as large as 0.25±0.22 in the T-ICL group and 0.24±0.15 in the T-Artiflex group. Post-operative contrast sensitivities were equal in both groups under mesopic condition for any given spatial frequency. There was 2.18% and 1.95% endothelial cell loss In the T-ICL and in T-Artiflex groups, respectively. There was no significant complication in any of the groups. CONCLUSION Both lenses showed promising results in terms of safety, efficacy, and predictability for correction of myopic astigmatism. As shown in this paired eye study, most outcomes were almost identical and neither of these lenses were clinically superior to the other.",2020,"There was no significant complication in any of the groups. ",['82 eyes of 41 patients with toric ICL implantation in one eye and toric Artiflex implantation in the contralateral eye to correct myopic astigmatism'],"['Toric Implantable Collamer Lens and Toric Artiflex Phakic IOLs', 'toric implantable collamer lens (T-ICL) and toric Artiflex (T-Artiflex) implantation']","['mean efficacy index', 'safety index', 'endothelial cell loss', 'Safety, efficacy, predictability, astigmatic vector changes, contrast sensitivity, endothelial cell count, and possible adverse events', 'mean index of success', 'safety, efficacy, and predictability']","[{'cui': 'C0015392', 'cui_str': 'Eye structure'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}, {'cui': 'C0441988', 'cui_str': 'Contralateral'}, {'cui': 'C0205202', 'cui_str': 'Corrected'}, {'cui': 'C2363771', 'cui_str': 'Myopic astigmatism'}]","[{'cui': 'C0021102', 'cui_str': 'Implant'}, {'cui': 'C1444754', 'cui_str': 'Length'}, {'cui': 'C0281658', 'cui_str': 'Intraocular Lymphoma'}, {'cui': 'C0023317', 'cui_str': 'Lens clear'}, {'cui': 'C0021107', 'cui_str': 'Implantation procedure'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0225336', 'cui_str': 'Endothelial cell'}, {'cui': 'C0012656', 'cui_str': 'Infectious Disease Vectors'}, {'cui': 'C0037400', 'cui_str': 'Social Change'}, {'cui': 'C0009928', 'cui_str': 'Contrast sensitivity'}, {'cui': 'C0429518', 'cui_str': 'Endothelial cell density'}, {'cui': 'C0332149', 'cui_str': 'Possible'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",41.0,0.0443315,"There was no significant complication in any of the groups. ","[{'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Ghoreishi', 'Affiliation': 'Parsian Vision Science Research Institute, Isfahan, Iran; Isfahan University of Medical Sciences.'}, {'ForeName': 'Abolfazl', 'Initials': 'A', 'LastName': 'Kashfi', 'Affiliation': 'Parsian Vision Science Research Institute, Isfahan, Iran. Electronic address: drkashfi@gmail.com.'}, {'ForeName': 'Mohammadreza', 'Initials': 'M', 'LastName': 'Peyman', 'Affiliation': 'Parsian Vision Science Research Institute, Isfahan, Iran.'}, {'ForeName': 'Mohadeseh', 'Initials': 'M', 'LastName': 'Mohammadinia', 'Affiliation': 'Parsian Vision Science Research Institute, Isfahan, Iran.'}]",American journal of ophthalmology,['10.1016/j.ajo.2020.06.021'] 3002,32621905,The ENGAGE-2 study: Engaging self-regulation targets to understand the mechanisms of behavior change and improve mood and weight outcomes in a randomized controlled trial (Phase 2).,"Despite evidence for effective integrated behavior therapy for treating comorbid obesity and depression, treatment response is highly variable and the underlying neurobiological mechanisms remain unknown. This hampers efforts to identify mechanistic targets in order to optimize treatment precision and potency. Funded within the NIH Science of Behavior Change (SOBC) Research Network, the 2-phased ENGAGE research project applies an experimental precision medicine approach to address this gap. The Phase 1 study focused on demonstrating technical feasibility, target engagement and potential neural mechanisms of responses to an integrated behavior therapy. This therapy combines a video-based behavioral weight loss program and problem-solving therapy for depression, with as-needed intensification of antidepressant medications, and its clinical effectiveness was demonstrated within a parent randomized clinical trial. Here, we describe the ENGAGE Phase 2 (ENGAGE-2) study protocol which builds on Phase 1 in 2 ways: (1) pilot testing of an motivational interviewing-enhanced, integrated behavior therapy in an independent, primarily minority patient sample, and (2) evaluation of a priori defined neural targets, specifically the negative affect (threat and sadness) circuits which demonstrated engagement and malleability in Phase 1, as mediators of therapeutic outcomes. Additionally, the Phase 2 study includes a conceptual and methodological extension to explore the role of microbiome-gut-brain and systemic immunological pathways in integrated behavioral treatment of obesity and depression. This protocol paper documents the conceptualization, design and the transdisciplinary methodologies in ENGAGE-2, which can inform future clinical and translational research in experimental precision medicine for behavior change and chronic disease management. Trial registration: ClinicalTrials.gov #NCT03841682.",2020,"The Phase 1 study focused on demonstrating technical feasibility, target engagement and potential neural mechanisms of responses to an integrated behavior therapy.",[],"['motivational interviewing-enhanced, integrated behavior therapy', 'video-based behavioral weight loss program and problem-solving therapy']",[],[],"[{'cui': 'C0683474', 'cui_str': 'Motivational interviewing'}, {'cui': 'C0004933', 'cui_str': 'Behavioral therapy'}, {'cui': 'C0042655', 'cui_str': 'Video'}, {'cui': 'C0002055', 'cui_str': 'Alkali'}, {'cui': 'C0004927', 'cui_str': 'Behavior finding'}, {'cui': 'C3179079', 'cui_str': 'Weight Loss Programs'}, {'cui': 'C1303140', 'cui_str': 'Problem solving therapy'}]",[],,0.0347898,"The Phase 1 study focused on demonstrating technical feasibility, target engagement and potential neural mechanisms of responses to an integrated behavior therapy.","[{'ForeName': 'Nan', 'Initials': 'N', 'LastName': 'Lv', 'Affiliation': 'Institute for Health Research and Policy, University of Illinois at Chicago, Chicago, IL 60608, United States.'}, {'ForeName': 'Olusola A', 'Initials': 'OA', 'LastName': 'Ajilore', 'Affiliation': 'Department of Psychiatry, University of Illinois at Chicago, Chicago, IL 60612, United States.'}, {'ForeName': 'Corina R', 'Initials': 'CR', 'LastName': 'Ronneberg', 'Affiliation': 'Institute for Health Research and Policy, University of Illinois at Chicago, Chicago, IL 60608, United States.'}, {'ForeName': 'Elizabeth M', 'Initials': 'EM', 'LastName': 'Venditti', 'Affiliation': 'Department of Psychiatry, University of Pittsburgh School of Medicine, Pittsburgh, PA 15213, United States.'}, {'ForeName': 'Mark B', 'Initials': 'MB', 'LastName': 'Snowden', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, University of Washington, Seattle, WA 98104, United States.'}, {'ForeName': 'Philip W', 'Initials': 'PW', 'LastName': 'Lavori', 'Affiliation': 'Department of Biomedical Data Science, Stanford University, Stanford, CA 94305, United States.'}, {'ForeName': 'Lan', 'Initials': 'L', 'LastName': 'Xiao', 'Affiliation': 'Department of Epidemiology and Population Health, Stanford University, Palo Alto, CA 94304, United States.'}, {'ForeName': 'Andrea N', 'Initials': 'AN', 'LastName': 'Goldstein-Piekarski', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA 94305, United States; MIRECC VISN21, Veterans Affairs Palo Alto Health Care System, Palo Alto, CA 94304, United States.'}, {'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Wielgosz', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA 94305, United States.'}, {'ForeName': 'Nancy E', 'Initials': 'NE', 'LastName': 'Wittels', 'Affiliation': 'Institute for Health Research and Policy, University of Illinois at Chicago, Chicago, IL 60608, United States.'}, {'ForeName': 'Amruta', 'Initials': 'A', 'LastName': 'Barve', 'Affiliation': 'Institute for Health Research and Policy, University of Illinois at Chicago, Chicago, IL 60608, United States.'}, {'ForeName': 'Aashutos S', 'Initials': 'AS', 'LastName': 'Patel', 'Affiliation': 'Institute for Health Research and Policy, University of Illinois at Chicago, Chicago, IL 60608, United States.'}, {'ForeName': 'Tessa L', 'Initials': 'TL', 'LastName': 'Eckley', 'Affiliation': 'Institute for Health Research and Policy, University of Illinois at Chicago, Chicago, IL 60608, United States.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Stetz', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA 94305, United States.'}, {'ForeName': 'Ben S', 'Initials': 'BS', 'LastName': 'Gerber', 'Affiliation': 'Division of Academic Internal Medicine and Geriatrics, College of Medicine, University of Illinois at Chicago, Chicago, IL 60612, United States.'}, {'ForeName': 'Joshua M', 'Initials': 'JM', 'LastName': 'Smyth', 'Affiliation': 'Departments of Biobehavioral Health and Medicine, Pennsylvania State University, University Park, PA 16802, United States.'}, {'ForeName': 'Janine M', 'Initials': 'JM', 'LastName': 'Simmons', 'Affiliation': 'National Institute of Mental Health (NIMH), National Institutes of Health, Bethesda, MD 20892, United States.'}, {'ForeName': 'Lisa G', 'Initials': 'LG', 'LastName': 'Rosas', 'Affiliation': 'Department of Epidemiology and Population Health, Stanford University, Palo Alto, CA 94304, United States.'}, {'ForeName': 'Leanne M', 'Initials': 'LM', 'LastName': 'Williams', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA 94305, United States; MIRECC VISN21, Veterans Affairs Palo Alto Health Care System, Palo Alto, CA 94304, United States.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Ma', 'Affiliation': 'Institute for Health Research and Policy, University of Illinois at Chicago, Chicago, IL 60608, United States; Department of Medicine, University of Illinois at Chicago, Chicago, IL 60608, United States. Electronic address: maj2015@uic.edu.'}]",Contemporary clinical trials,['10.1016/j.cct.2020.106072'] 3003,32621918,Dexmedetomidine pretreatment attenuates myocardial ischemia reperfusion induced acute kidney injury and endoplasmic reticulum stress in human and rat.,"BACKGROUND Patients undergoing cardiopulmonary bypass (CPB) often develop acute kidney injury (AKI) caused by myocardial ischemia reperfusion (MI/R), and this renal injury can be resolved notably by dexmedetomidine. Endoplasmic reticulum (ER) stress was reported to get involved in organ injury including AKI. OBJECTIVES The current study aimed to address the correlation between MI/R induced AKI with ER stress and to assess the effects of dexmedetomidine pretreatment on AKI protection. METHOD Patients selected for heart valve replacement surgery were randomly assigned to NS group (pre-anesthesia with 0.9% NaCl) and DEX group (pre-anesthesia with dexmedetomidine). Rat MI/R model was induced by occluding coronary artery for 30 min followed by 48-hour reperfusion. Rats were randomized into Sham (0.9% NaCl), I/R (MI/R + 0.9% NaCl) and I/R + DEX (MI/R + dexmedetomidine). Organ function and ER stress condition were evaluated by blood chemistry, pathology, and molecular test. RESULTS Clinical data indicated dexmedetomidine pretreatment attenuated AKI and oxidative stress as well as postischemic myocardial injury in patients. Accordingly animal results suggested dexmedetomidine reduced cellular injury and improved postischemic myocardial and renal function. Dexmedetomidine also reduced myocardial and renal cells apoptosis and down-regulated ER stress. CONCLUSIONS These results suggested that dexmedetomidine pretreatment attenuates MI/R injury-induced AKI by relieving the ER stress.",2020,"Dexmedetomidine also reduced myocardial and renal cells apoptosis and down-regulated ER stress. ","['Patients undergoing', 'Patients selected for heart valve replacement surgery', 'human and rat']","['cardiopulmonary bypass (CPB', 'NS group (pre-anesthesia with 0.9% NaCl) and DEX group (pre-anesthesia with dexmedetomidine', 'Dexmedetomidine', '\u202fDEX (MI/R\u202f+\u202fdexmedetomidine', 'dexmedetomidine']","['MI/R injury-induced AKI', 'Endoplasmic reticulum (ER) stress', 'AKI and oxidative stress', 'myocardial and renal cells apoptosis and down-regulated ER stress', 'cellular injury and improved postischemic myocardial and renal function']","[{'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0190173', 'cui_str': 'Heart valve replacement'}, {'cui': 'C0038895', 'cui_str': 'operative procedures'}, {'cui': 'C0086418', 'cui_str': 'Homo sapiens'}, {'cui': 'C0034693', 'cui_str': 'Rattus norvegicus'}]","[{'cui': 'C0007202', 'cui_str': 'Cardiopulmonary bypass operation'}, {'cui': 'C0439745', 'cui_str': 'Grouped'}, {'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0002903', 'cui_str': 'Administration of anesthesia'}, {'cui': 'C0445115', 'cui_str': 'Normal Saline'}, {'cui': 'C0011816', 'cui_str': 'Dextromethorphan'}, {'cui': 'C0113293', 'cui_str': 'Dexmedetomidine'}, {'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0035124', 'cui_str': 'Reperfusion'}]","[{'cui': 'C0010054', 'cui_str': 'Coronary arteriosclerosis'}, {'cui': 'C0035126', 'cui_str': 'Ischemia-reperfusion injury'}, {'cui': 'C0205263', 'cui_str': 'Induced'}, {'cui': 'C0022660', 'cui_str': 'Acute renal failure syndrome'}, {'cui': 'C0014239', 'cui_str': 'Endoplasmic reticulum'}, {'cui': 'C0038435', 'cui_str': 'Stress'}, {'cui': 'C0242606', 'cui_str': 'Oxidative stress'}, {'cui': 'C0022646', 'cui_str': 'Kidney structure'}, {'cui': 'C0007584', 'cui_str': 'Cell count'}, {'cui': 'C0162638', 'cui_str': 'Apoptosis'}, {'cui': 'C0851285', 'cui_str': 'Regulation'}, {'cui': 'C3178870', 'cui_str': 'Stress, Endoplasmic Reticulum'}, {'cui': 'C0007634', 'cui_str': 'Cell structure'}, {'cui': 'C0005604', 'cui_str': 'Birth trauma'}, {'cui': 'C0184511', 'cui_str': 'Improved'}, {'cui': 'C0022662', 'cui_str': 'Renal function study'}]",,0.0396497,"Dexmedetomidine also reduced myocardial and renal cells apoptosis and down-regulated ER stress. ","[{'ForeName': 'Chaoliang', 'Initials': 'C', 'LastName': 'Tang', 'Affiliation': 'Department of Anesthesiology, The First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei 230001, Anhui, China. Electronic address: chaolt@ustc.edu.cn.'}, {'ForeName': 'Yida', 'Initials': 'Y', 'LastName': 'Hu', 'Affiliation': 'Department of Anesthesiology, Renmin Hospital of Wuhan University, Wuhan 430060, Hubei, China.'}, {'ForeName': 'Jie', 'Initials': 'J', 'LastName': 'Gao', 'Affiliation': 'Department of Anesthesia, Critical Care & Pain Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA 02144, USA.'}, {'ForeName': 'Jiazhen', 'Initials': 'J', 'LastName': 'Jiang', 'Affiliation': 'Department of Emergency, Huashan Hospital North, Fudan University, Shanghai, 201907, China.'}, {'ForeName': 'Si', 'Initials': 'S', 'LastName': 'Shi', 'Affiliation': 'Department of Anesthesiology, Renmin Hospital of Wuhan University, Wuhan 430060, Hubei, China.'}, {'ForeName': 'Jiawu', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'Department of Anesthesiology, The First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei 230001, Anhui, China.'}, {'ForeName': 'Qingtian', 'Initials': 'Q', 'LastName': 'Geng', 'Affiliation': 'Department of Anesthesiology, The First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei 230001, Anhui, China.'}, {'ForeName': 'Xinghan', 'Initials': 'X', 'LastName': 'Liang', 'Affiliation': 'Department of Clinical Laboratory, The First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei 230000, Anhui, China.'}, {'ForeName': 'Xiaoqing', 'Initials': 'X', 'LastName': 'Chai', 'Affiliation': 'Department of Anesthesiology, The First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China, Hefei 230001, Anhui, China. Electronic address: xiaoqingchai@163.com.'}]",Life sciences,['10.1016/j.lfs.2020.118004'] 3004,32622071,Delta-like 1 (DLK1) is a possible mediator of vitamin D effects on bone and energy metabolism.,"Vitamin D effects on bone and mineral metabolism are well recognized, and its anti-inflammatory actions are gaining particular interest. Delta-like 1 (DLK1) is a protein, expressed by progenitor cells of different tissues, and increases the size of progenitor cell population during the inflammatory phase of tissue regeneration. DLK1 also plays a role in energy metabolism as it antagonizes insulin signaling in bone. In this one-year randomized clinical trial of overweight elderly individuals that received either 600 or 3750 IU daily cholecalciferol we assessed the effect of vitamin D supplementation on pre-specified secondary outcomes: DLK1, leptin, adiponectin, C-Reactive Protein (CRP) and Vascular Cell Adhesion Molecule (VCAM). We also examined correlations between DLK1and bone (BMD, bone markers), fat (adipokines, body composition), insulin sensitivity and inflammatory markers. Multivariate analyses were conducted to further explore these associations. Overall, there was a significant increase in serum DLK1 and leptin and a decrease in VCAM, but no change in CRP, after 12 months of vitamin D supplementation. DLK1 was negatively correlated with BMD and positively correlated with bone markers, associations that persisted after adjusting for age, gender and BMI. DLK1 was also positively associated with indices of insulin resistance and negatively with indices of insulin sensitivity. Correlations between DLK1 and fat parameters, such as adipokines, and DXA derived fat mass were less consistent. There were no correlations between DLK1 and inflammatory markers. In conclusion, twelve months supplementation of vitamin D3 increased serum DLK1. DLK1 was negatively associated with indices of bone health and fuel metabolism, and with 1,25(OH) 2 D levels. Similar to the role of DLK1 in animal models, our findings support the hypothesis that DLK1 can be targeted to regulate bone and energy metabolism and develop drugs to improve BMD and insulin sensitivity. However, further studies are needed to explore the role of DLK1 and its relationship to vitamin D metabolites in vivo.",2020,"Correlations between DLK1 and fat parameters, such as adipokines, and DXA derived fat mass were less consistent.",['overweight elderly individuals'],"['Vitamin D', 'Delta-like 1 (DLK1', '600 or 3750\u202fIU daily cholecalciferol', 'vitamin D supplementation', 'vitamin D3']","['bone health and fuel metabolism, and with 1,25(OH) 2 D levels', 'serum DLK1 and leptin', 'serum DLK1', 'DLK1 and inflammatory markers', 'DLK1', 'BMD and insulin sensitivity', 'leptin, adiponectin, C-Reactive Protein (CRP) and Vascular Cell Adhesion Molecule (VCAM', 'VCAM', 'DLK1and bone (BMD, bone markers), fat (adipokines, body composition), insulin sensitivity and inflammatory markers', 'bone and mineral metabolism', 'insulin resistance and negatively with indices of insulin sensitivity']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0001792', 'cui_str': 'Elderly person'}, {'cui': 'C0027361', 'cui_str': 'Person'}]","[{'cui': 'C0008318', 'cui_str': 'Cholecalciferol'}, {'cui': 'C0439097', 'cui_str': 'Delta'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C4517746', 'cui_str': '3750'}, {'cui': 'C0332173', 'cui_str': 'Daily'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}]","[{'cui': 'C0262950', 'cui_str': 'Bone structure'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0556991', 'cui_str': 'Fuel'}, {'cui': 'C0025519', 'cui_str': 'General metabolic function'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0439097', 'cui_str': 'Delta'}, {'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C0006560', 'cui_str': 'C reactive protein'}, {'cui': 'C0078056', 'cui_str': 'Lymphocyte antigen CD106'}, {'cui': 'C0181734', 'cui_str': 'Bone marker'}, {'cui': 'C0015677', 'cui_str': 'Fat'}, {'cui': 'C1955907', 'cui_str': 'Adipokine'}, {'cui': 'C0005885', 'cui_str': 'Body composition'}, {'cui': 'C0006660', 'cui_str': 'Physiologic Calcification'}, {'cui': 'C0021655', 'cui_str': 'Insulin resistance'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",,0.0714769,"Correlations between DLK1 and fat parameters, such as adipokines, and DXA derived fat mass were less consistent.","[{'ForeName': 'Aya', 'Initials': 'A', 'LastName': 'Bassatne', 'Affiliation': 'Calcium Metabolism and Osteoporosis Program, Division of Endocrinology and Metabolism, Department of Internal Medicine, American University of Beirut Medical Center, Beirut, Lebanon.'}, {'ForeName': 'Abbas', 'Initials': 'A', 'LastName': 'Jafari', 'Affiliation': 'Molecular Endocrinology and Stem Cell Research Unit (KMEB), Department of Endocrinology and Metabolism, Odense University Hospital and Department of Clinical Research, University of Southern Denmark, Odense, Denmark; Department of Cellular and Molecular Medicine, Novo Nordisk Foundation Center for Stem Cell Biology (DanStem), University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Moustapha', 'Initials': 'M', 'LastName': 'Kassem', 'Affiliation': 'Molecular Endocrinology and Stem Cell Research Unit (KMEB), Department of Endocrinology and Metabolism, Odense University Hospital and Department of Clinical Research, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Christos', 'Initials': 'C', 'LastName': 'Mantzoros', 'Affiliation': 'Division of Endocrinology, Diabetes and Metabolism, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA 02215, USA.'}, {'ForeName': 'Maya', 'Initials': 'M', 'LastName': 'Rahme', 'Affiliation': 'Calcium Metabolism and Osteoporosis Program, Division of Endocrinology and Metabolism, Department of Internal Medicine, American University of Beirut Medical Center, Beirut, Lebanon.'}, {'ForeName': 'Ghada El-Hajj', 'Initials': 'GE', 'LastName': 'Fuleihan', 'Affiliation': 'Calcium Metabolism and Osteoporosis Program, Division of Endocrinology and Metabolism, Department of Internal Medicine, American University of Beirut Medical Center, Beirut, Lebanon. Electronic address: gf01@aub.edu.lb.'}]",Bone,['10.1016/j.bone.2020.115510'] 3005,32611638,Minimal manifestation status and prednisone withdrawal in the MGTX trial.,"OBJECTIVE To examine whether sustained minimal manifestation status (MMS) with complete withdrawal of prednisone is better achieved in thymectomized myasthenia gravis (MG) patients. METHODS This study is a post hoc analysis of data from the randomized trial of thymectomy in myasthenia gravis (MGTX). MGTX was a multicenter, randomized, rater-blinded 3-year trial that was followed by a voluntary 2-year extension for patients with acetylcholine receptor (AChR) antibody positive MG without thymoma. Patients were randomized 1:1 to thymectomy plus prednisone versus prednisone alone. Participants were age 18-65 years at enrollment with disease duration less than 5 years. All patients received oral prednisone titrated up to 100mg on alternate-days until they achieved MMS, which prompted a standardized prednisone taper as long as MMS was maintained. The achievement rate of sustained MMS (no symptoms of MG for 6 months) with complete withdrawal of prednisone, was compared between the thymectomy plus prednisone and prednisone alone groups. RESULTS MG patients in the thymectomy plus prednisone group achieved sustained MMS with complete withdrawal of prednisone more frequently (64% vs 38%) and quickly compared to the prednisone alone group (median time 30 months vs no median time achieved, P<0.001) over the 5-year study period. Prednisone associated adverse symptoms were more frequent in the prednisone alone group and distress level increased with higher doses of prednisone. CONCLUSIONS Thymectomy benefits MG patients by increasing the likelihood of achieving sustained MMS with complete withdrawal of prednisone. TRIAL REGISTRATION The trial was registered on clinicaltrials.gov, number NCT00294658Classification of Evidence: This study provides Class II evidence that for generalized MG patients with AChR antibody, those receiving thymectomy plus prednisone are more likely to attain sustained MMS and complete prednisone withdrawal than those on prednisone alone.",2020,"Prednisone associated adverse symptoms were more frequent in the prednisone alone group and distress level increased with higher doses of prednisone. ","['generalized MG patients with AChR antibody, those receiving', 'thymectomized myasthenia gravis (MG) patients', 'patients with acetylcholine receptor (AChR) antibody positive MG without thymoma', 'Participants were age 18-65 years at enrollment with disease duration less than 5 years', 'myasthenia gravis (MGTX']","['prednisone', 'thymectomy plus prednisone', 'Prednisone', 'MGTX', 'thymectomy', 'oral prednisone', 'thymectomy plus prednisone versus prednisone alone']","['achievement rate of sustained MMS', 'distress level', 'sustained MMS', 'adverse symptoms']","[{'cui': 'C0472367', 'cui_str': 'Generalized myasthenia'}, {'cui': 'C0030705', 'cui_str': 'Patient'}, {'cui': 'C0236516', 'cui_str': 'Acetylcholine receptor antibody'}, {'cui': 'C0026896', 'cui_str': 'Myasthenia gravis'}, {'cui': 'C0034792', 'cui_str': 'Cholinergic receptor'}, {'cui': 'C0741132', 'cui_str': 'Antibody test positive'}, {'cui': 'C0040100', 'cui_str': 'Thymoma'}, {'cui': 'C0001779', 'cui_str': 'Age'}, {'cui': 'C0439234', 'cui_str': 'year'}, {'cui': 'C0036369', 'cui_str': 'School Enrollment'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0449238', 'cui_str': 'Duration'}, {'cui': 'C0439092', 'cui_str': '<'}, {'cui': 'C0174725', 'cui_str': 'margatoxin'}]","[{'cui': 'C0032952', 'cui_str': 'Prednisone'}, {'cui': 'C0040071', 'cui_str': 'Excision of thymus'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0174725', 'cui_str': 'margatoxin'}, {'cui': 'C0226896', 'cui_str': 'Oral cavity structure'}]","[{'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C0547040', 'cui_str': 'Minimal'}, {'cui': 'C0205319', 'cui_str': 'Manifest'}, {'cui': 'C0449438', 'cui_str': 'Status'}, {'cui': 'C0231303', 'cui_str': 'Distress'}, {'cui': 'C0441889', 'cui_str': 'Levels'}, {'cui': 'C0443318', 'cui_str': 'Sustained'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",,0.173208,"Prednisone associated adverse symptoms were more frequent in the prednisone alone group and distress level increased with higher doses of prednisone. ","[{'ForeName': 'Ikjae', 'Initials': 'I', 'LastName': 'Lee', 'Affiliation': 'From the Department of Neurology, University of Alabama at Birmingham, Birmingham (I.L.); the Department of Biostatistics, University of Alabama at Birmingham, Birmingham (H.-C.K., I.B.A., G.R.C., T.M., G.M); the Department of Neurology, George Washington University School of Medicine and Health Sciences, Washington, DC (H.J.K.); the Department of Neurology, Greater Manchester Neuroscience Center, Salford, Greater Manchester, UK (J.S.); the Institute of Pathology, University Medical Center Göttingen, Göttingen (P.S.); the Department of Neurology, McGill University, Montreal (C.H.C.), and the Division of Neurology, University of British Columbia, Vancouver (J. Oger) - both in Canada; the Department of Neurology, University of Chile, Santiago (G.C.); the Division of Neurology, Department of Medicine, University of Cape Town, Cape Town, South Africa (J.M.H.); the Department of Neurosciences, Mental Health and Sensory Organs, Sapienza University of Rome (G.A.), the Department of Neurology, Catholic University, (A.E.) - both in Rome; the Department of Neurology, Johannes Gutenberg University, Mainz, Germany (W.N.); the Department of Neurology, University of Rochester Medical Center, Rochester, New York (E.C.); the Division of Neurology, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand (R.W.); the Department of Neurology, Royal Melbourne Hospital, Victoria, Australia (J.O.K.); the Department of Neurology, University of Southern California, Los Angeles (S.R.B.), and the Department of Neurology, University of California Irvine Medical Center, Orange (T.M.) - both in California; the Department of Neurology, Medical College of Wisconsin, Milwaukee (A.C.B.); the Department of Neurology, Harvard Medical School, Boston (A.A.A.); Nerve and Muscle Center of Texas, Houston (A.I.S.), and the Department of Neurology, University of Texas Health Science Center, San Antonio (C.E.J.) - both in Texas; the Department of Neurology, Case Western Reserve University, Cleveland (B.K.), and the Department of Neurology, Ohio State University Wexner Medical Center, Columbus (J.T.K.) - both in Ohio; Walton Centre for Neurology and Neurosurgery, Liverpool (B.R.F.L.), and Nuffield Department of Clinical Neurosciences, Oxford University, Oxford (C.B., A.V.) - both in the United Kingdom; Unit of Neurology, University of Brasilia, Brasilia (E.D.-T.), the Department of Neurology, Federal University, Rio de Janeiro (M.W.-C.), and the Department of Neurology, Universidade Federal do Parana, Curitiba (L.C.W.) - all in Brazil; the Department of Neurology, Kanazawa University, Kanazawa, Japan (H.Y.); the Department of Neurology, University of Florida, Jacksonville (M.T.P.), and the Department of Neurology, University of Miami, Miami (M.B.) - both in Florida; the Department of Neurology, Augusta University, Augusta (M.H.R.); the Department of Neurology, Medical University of Warsaw, Warsaw, Poland (A.K.-P.); the Department of Neurology, Indiana School of Medicine, Indianapolis (R.M.P.); the Department of Neurology, Leiden University Medical Center, Leiden, the Netherlands (J.J.G.M.V.); the Department of Neurology, Duke University Medical Center, Durham, NC (J.M.M.); the Department of Neurology, University of Kansas Medical Center, Kansas City (R.J.B.); the Department of Neurological Sciences, University of Vermont College of Medicine, Burlington (R.T.); the Division of Extramural Research, National Institutes of Health, National Institute of Neurological Disorders and Stroke, Bethesda, MD (R.C.); the Section of General Thoracic Surgery, Columbia University Medical Center, New York (J.R.S.); the Department of Neurology, University at Buffalo Jacobs School of Medicine and Biomedical Sciences, Buffalo (G.I.W.). leeij15@gmail.com.'}, {'ForeName': 'Hui-Chien', 'Initials': 'HC', 'LastName': 'Kuo', 'Affiliation': 'From the Department of Neurology, University of Alabama at Birmingham, Birmingham (I.L.); the Department of Biostatistics, University of Alabama at Birmingham, Birmingham (H.-C.K., I.B.A., G.R.C., T.M., G.M); the Department of Neurology, George Washington University School of Medicine and Health Sciences, Washington, DC (H.J.K.); the Department of Neurology, Greater Manchester Neuroscience Center, Salford, Greater Manchester, UK (J.S.); the Institute of Pathology, University Medical Center Göttingen, Göttingen (P.S.); the Department of Neurology, McGill University, Montreal (C.H.C.), and the Division of Neurology, University of British Columbia, Vancouver (J. Oger) - both in Canada; the Department of Neurology, University of Chile, Santiago (G.C.); the Division of Neurology, Department of Medicine, University of Cape Town, Cape Town, South Africa (J.M.H.); the Department of Neurosciences, Mental Health and Sensory Organs, Sapienza University of Rome (G.A.), the Department of Neurology, Catholic University, (A.E.) - both in Rome; the Department of Neurology, Johannes Gutenberg University, Mainz, Germany (W.N.); the Department of Neurology, University of Rochester Medical Center, Rochester, New York (E.C.); the Division of Neurology, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand (R.W.); the Department of Neurology, Royal Melbourne Hospital, Victoria, Australia (J.O.K.); the Department of Neurology, University of Southern California, Los Angeles (S.R.B.), and the Department of Neurology, University of California Irvine Medical Center, Orange (T.M.) - both in California; the Department of Neurology, Medical College of Wisconsin, Milwaukee (A.C.B.); the Department of Neurology, Harvard Medical School, Boston (A.A.A.); Nerve and Muscle Center of Texas, Houston (A.I.S.), and the Department of Neurology, University of Texas Health Science Center, San Antonio (C.E.J.) - both in Texas; the Department of Neurology, Case Western Reserve University, Cleveland (B.K.), and the Department of Neurology, Ohio State University Wexner Medical Center, Columbus (J.T.K.) - both in Ohio; Walton Centre for Neurology and Neurosurgery, Liverpool (B.R.F.L.), and Nuffield Department of Clinical Neurosciences, Oxford University, Oxford (C.B., A.V.) - both in the United Kingdom; Unit of Neurology, University of Brasilia, Brasilia (E.D.-T.), the Department of Neurology, Federal University, Rio de Janeiro (M.W.-C.), and the Department of Neurology, Universidade Federal do Parana, Curitiba (L.C.W.) - all in Brazil; the Department of Neurology, Kanazawa University, Kanazawa, Japan (H.Y.); the Department of Neurology, University of Florida, Jacksonville (M.T.P.), and the Department of Neurology, University of Miami, Miami (M.B.) - both in Florida; the Department of Neurology, Augusta University, Augusta (M.H.R.); the Department of Neurology, Medical University of Warsaw, Warsaw, Poland (A.K.-P.); the Department of Neurology, Indiana School of Medicine, Indianapolis (R.M.P.); the Department of Neurology, Leiden University Medical Center, Leiden, the Netherlands (J.J.G.M.V.); the Department of Neurology, Duke University Medical Center, Durham, NC (J.M.M.); the Department of Neurology, University of Kansas Medical Center, Kansas City (R.J.B.); the Department of Neurological Sciences, University of Vermont College of Medicine, Burlington (R.T.); the Division of Extramural Research, National Institutes of Health, National Institute of Neurological Disorders and Stroke, Bethesda, MD (R.C.); the Section of General Thoracic Surgery, Columbia University Medical Center, New York (J.R.S.); the Department of Neurology, University at Buffalo Jacobs School of Medicine and Biomedical Sciences, Buffalo (G.I.W.).'}, {'ForeName': 'Inmaculada B', 'Initials': 'IB', 'LastName': 'Aban', 'Affiliation': 'From the Department of Neurology, University of Alabama at Birmingham, Birmingham (I.L.); the Department of Biostatistics, University of Alabama at Birmingham, Birmingham (H.-C.K., I.B.A., G.R.C., T.M., G.M); the Department of Neurology, George Washington University School of Medicine and Health Sciences, Washington, DC (H.J.K.); the Department of Neurology, Greater Manchester Neuroscience Center, Salford, Greater Manchester, UK (J.S.); the Institute of Pathology, University Medical Center Göttingen, Göttingen (P.S.); the Department of Neurology, McGill University, Montreal (C.H.C.), and the Division of Neurology, University of British Columbia, Vancouver (J. Oger) - both in Canada; the Department of Neurology, University of Chile, Santiago (G.C.); the Division of Neurology, Department of Medicine, University of Cape Town, Cape Town, South Africa (J.M.H.); the Department of Neurosciences, Mental Health and Sensory Organs, Sapienza University of Rome (G.A.), the Department of Neurology, Catholic University, (A.E.) - both in Rome; the Department of Neurology, Johannes Gutenberg University, Mainz, Germany (W.N.); the Department of Neurology, University of Rochester Medical Center, Rochester, New York (E.C.); the Division of Neurology, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand (R.W.); the Department of Neurology, Royal Melbourne Hospital, Victoria, Australia (J.O.K.); the Department of Neurology, University of Southern California, Los Angeles (S.R.B.), and the Department of Neurology, University of California Irvine Medical Center, Orange (T.M.) - both in California; the Department of Neurology, Medical College of Wisconsin, Milwaukee (A.C.B.); the Department of Neurology, Harvard Medical School, Boston (A.A.A.); Nerve and Muscle Center of Texas, Houston (A.I.S.), and the Department of Neurology, University of Texas Health Science Center, San Antonio (C.E.J.) - both in Texas; the Department of Neurology, Case Western Reserve University, Cleveland (B.K.), and the Department of Neurology, Ohio State University Wexner Medical Center, Columbus (J.T.K.) - both in Ohio; Walton Centre for Neurology and Neurosurgery, Liverpool (B.R.F.L.), and Nuffield Department of Clinical Neurosciences, Oxford University, Oxford (C.B., A.V.) - both in the United Kingdom; Unit of Neurology, University of Brasilia, Brasilia (E.D.-T.), the Department of Neurology, Federal University, Rio de Janeiro (M.W.-C.), and the Department of Neurology, Universidade Federal do Parana, Curitiba (L.C.W.) - all in Brazil; the Department of Neurology, Kanazawa University, Kanazawa, Japan (H.Y.); the Department of Neurology, University of Florida, Jacksonville (M.T.P.), and the Department of Neurology, University of Miami, Miami (M.B.) - both in Florida; the Department of Neurology, Augusta University, Augusta (M.H.R.); the Department of Neurology, Medical University of Warsaw, Warsaw, Poland (A.K.-P.); the Department of Neurology, Indiana School of Medicine, Indianapolis (R.M.P.); the Department of Neurology, Leiden University Medical Center, Leiden, the Netherlands (J.J.G.M.V.); the Department of Neurology, Duke University Medical Center, Durham, NC (J.M.M.); the Department of Neurology, University of Kansas Medical Center, Kansas City (R.J.B.); the Department of Neurological Sciences, University of Vermont College of Medicine, Burlington (R.T.); the Division of Extramural Research, National Institutes of Health, National Institute of Neurological Disorders and Stroke, Bethesda, MD (R.C.); the Section of General Thoracic Surgery, Columbia University Medical Center, New York (J.R.S.); the Department of Neurology, University at Buffalo Jacobs School of Medicine and Biomedical Sciences, Buffalo (G.I.W.).'}, {'ForeName': 'Gary R', 'Initials': 'GR', 'LastName': 'Cutter', 'Affiliation': 'From the Department of Neurology, University of Alabama at Birmingham, Birmingham (I.L.); the Department of Biostatistics, University of Alabama at Birmingham, Birmingham (H.-C.K., I.B.A., G.R.C., T.M., G.M); the Department of Neurology, George Washington University School of Medicine and Health Sciences, Washington, DC (H.J.K.); the Department of Neurology, Greater Manchester Neuroscience Center, Salford, Greater Manchester, UK (J.S.); the Institute of Pathology, University Medical Center Göttingen, Göttingen (P.S.); the Department of Neurology, McGill University, Montreal (C.H.C.), and the Division of Neurology, University of British Columbia, Vancouver (J. Oger) - both in Canada; the Department of Neurology, University of Chile, Santiago (G.C.); the Division of Neurology, Department of Medicine, University of Cape Town, Cape Town, South Africa (J.M.H.); the Department of Neurosciences, Mental Health and Sensory Organs, Sapienza University of Rome (G.A.), the Department of Neurology, Catholic University, (A.E.) - both in Rome; the Department of Neurology, Johannes Gutenberg University, Mainz, Germany (W.N.); the Department of Neurology, University of Rochester Medical Center, Rochester, New York (E.C.); the Division of Neurology, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand (R.W.); the Department of Neurology, Royal Melbourne Hospital, Victoria, Australia (J.O.K.); the Department of Neurology, University of Southern California, Los Angeles (S.R.B.), and the Department of Neurology, University of California Irvine Medical Center, Orange (T.M.) - both in California; the Department of Neurology, Medical College of Wisconsin, Milwaukee (A.C.B.); the Department of Neurology, Harvard Medical School, Boston (A.A.A.); Nerve and Muscle Center of Texas, Houston (A.I.S.), and the Department of Neurology, University of Texas Health Science Center, San Antonio (C.E.J.) - both in Texas; the Department of Neurology, Case Western Reserve University, Cleveland (B.K.), and the Department of Neurology, Ohio State University Wexner Medical Center, Columbus (J.T.K.) - both in Ohio; Walton Centre for Neurology and Neurosurgery, Liverpool (B.R.F.L.), and Nuffield Department of Clinical Neurosciences, Oxford University, Oxford (C.B., A.V.) - both in the United Kingdom; Unit of Neurology, University of Brasilia, Brasilia (E.D.-T.), the Department of Neurology, Federal University, Rio de Janeiro (M.W.-C.), and the Department of Neurology, Universidade Federal do Parana, Curitiba (L.C.W.) - all in Brazil; the Department of Neurology, Kanazawa University, Kanazawa, Japan (H.Y.); the Department of Neurology, University of Florida, Jacksonville (M.T.P.), and the Department of Neurology, University of Miami, Miami (M.B.) - both in Florida; the Department of Neurology, Augusta University, Augusta (M.H.R.); the Department of Neurology, Medical University of Warsaw, Warsaw, Poland (A.K.-P.); the Department of Neurology, Indiana School of Medicine, Indianapolis (R.M.P.); the Department of Neurology, Leiden University Medical Center, Leiden, the Netherlands (J.J.G.M.V.); the Department of Neurology, Duke University Medical Center, Durham, NC (J.M.M.); the Department of Neurology, University of Kansas Medical Center, Kansas City (R.J.B.); the Department of Neurological Sciences, University of Vermont College of Medicine, Burlington (R.T.); the Division of Extramural Research, National Institutes of Health, National Institute of Neurological Disorders and Stroke, Bethesda, MD (R.C.); the Section of General Thoracic Surgery, Columbia University Medical Center, New York (J.R.S.); the Department of Neurology, University at Buffalo Jacobs School of Medicine and Biomedical Sciences, Buffalo (G.I.W.).'}, {'ForeName': 'Tarrant', 'Initials': 'T', 'LastName': 'McPherson', 'Affiliation': 'From the Department of Neurology, University of Alabama at Birmingham, Birmingham (I.L.); the Department of Biostatistics, University of Alabama at Birmingham, Birmingham (H.-C.K., I.B.A., G.R.C., T.M., G.M); the Department of Neurology, George Washington University School of Medicine and Health Sciences, Washington, DC (H.J.K.); the Department of Neurology, Greater Manchester Neuroscience Center, Salford, Greater Manchester, UK (J.S.); the Institute of Pathology, University Medical Center Göttingen, Göttingen (P.S.); the Department of Neurology, McGill University, Montreal (C.H.C.), and the Division of Neurology, University of British Columbia, Vancouver (J. Oger) - both in Canada; the Department of Neurology, University of Chile, Santiago (G.C.); the Division of Neurology, Department of Medicine, University of Cape Town, Cape Town, South Africa (J.M.H.); the Department of Neurosciences, Mental Health and Sensory Organs, Sapienza University of Rome (G.A.), the Department of Neurology, Catholic University, (A.E.) - both in Rome; the Department of Neurology, Johannes Gutenberg University, Mainz, Germany (W.N.); the Department of Neurology, University of Rochester Medical Center, Rochester, New York (E.C.); the Division of Neurology, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand (R.W.); the Department of Neurology, Royal Melbourne Hospital, Victoria, Australia (J.O.K.); the Department of Neurology, University of Southern California, Los Angeles (S.R.B.), and the Department of Neurology, University of California Irvine Medical Center, Orange (T.M.) - both in California; the Department of Neurology, Medical College of Wisconsin, Milwaukee (A.C.B.); the Department of Neurology, Harvard Medical School, Boston (A.A.A.); Nerve and Muscle Center of Texas, Houston (A.I.S.), and the Department of Neurology, University of Texas Health Science Center, San Antonio (C.E.J.) - both in Texas; the Department of Neurology, Case Western Reserve University, Cleveland (B.K.), and the Department of Neurology, Ohio State University Wexner Medical Center, Columbus (J.T.K.) - both in Ohio; Walton Centre for Neurology and Neurosurgery, Liverpool (B.R.F.L.), and Nuffield Department of Clinical Neurosciences, Oxford University, Oxford (C.B., A.V.) - both in the United Kingdom; Unit of Neurology, University of Brasilia, Brasilia (E.D.-T.), the Department of Neurology, Federal University, Rio de Janeiro (M.W.-C.), and the Department of Neurology, Universidade Federal do Parana, Curitiba (L.C.W.) - all in Brazil; the Department of Neurology, Kanazawa University, Kanazawa, Japan (H.Y.); the Department of Neurology, University of Florida, Jacksonville (M.T.P.), and the Department of Neurology, University of Miami, Miami (M.B.) - both in Florida; the Department of Neurology, Augusta University, Augusta (M.H.R.); the Department of Neurology, Medical University of Warsaw, Warsaw, Poland (A.K.-P.); the Department of Neurology, Indiana School of Medicine, Indianapolis (R.M.P.); the Department of Neurology, Leiden University Medical Center, Leiden, the Netherlands (J.J.G.M.V.); the Department of Neurology, Duke University Medical Center, Durham, NC (J.M.M.); the Department of Neurology, University of Kansas Medical Center, Kansas City (R.J.B.); the Department of Neurological Sciences, University of Vermont College of Medicine, Burlington (R.T.); the Division of Extramural Research, National Institutes of Health, National Institute of Neurological Disorders and Stroke, Bethesda, MD (R.C.); the Section of General Thoracic Surgery, Columbia University Medical Center, New York (J.R.S.); the Department of Neurology, University at Buffalo Jacobs School of Medicine and Biomedical Sciences, Buffalo (G.I.W.).'}, {'ForeName': 'Henry J', 'Initials': 'HJ', 'LastName': 'Kaminski', 'Affiliation': 'From the Department of Neurology, University of Alabama at Birmingham, Birmingham (I.L.); the Department of Biostatistics, University of Alabama at Birmingham, Birmingham (H.-C.K., I.B.A., G.R.C., T.M., G.M); the Department of Neurology, George Washington University School of Medicine and Health Sciences, Washington, DC (H.J.K.); the Department of Neurology, Greater Manchester Neuroscience Center, Salford, Greater Manchester, UK (J.S.); the Institute of Pathology, University Medical Center Göttingen, Göttingen (P.S.); the Department of Neurology, McGill University, Montreal (C.H.C.), and the Division of Neurology, University of British Columbia, Vancouver (J. Oger) - both in Canada; the Department of Neurology, University of Chile, Santiago (G.C.); the Division of Neurology, Department of Medicine, University of Cape Town, Cape Town, South Africa (J.M.H.); the Department of Neurosciences, Mental Health and Sensory Organs, Sapienza University of Rome (G.A.), the Department of Neurology, Catholic University, (A.E.) - both in Rome; the Department of Neurology, Johannes Gutenberg University, Mainz, Germany (W.N.); the Department of Neurology, University of Rochester Medical Center, Rochester, New York (E.C.); the Division of Neurology, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand (R.W.); the Department of Neurology, Royal Melbourne Hospital, Victoria, Australia (J.O.K.); the Department of Neurology, University of Southern California, Los Angeles (S.R.B.), and the Department of Neurology, University of California Irvine Medical Center, Orange (T.M.) - both in California; the Department of Neurology, Medical College of Wisconsin, Milwaukee (A.C.B.); the Department of Neurology, Harvard Medical School, Boston (A.A.A.); Nerve and Muscle Center of Texas, Houston (A.I.S.), and the Department of Neurology, University of Texas Health Science Center, San Antonio (C.E.J.) - both in Texas; the Department of Neurology, Case Western Reserve University, Cleveland (B.K.), and the Department of Neurology, Ohio State University Wexner Medical Center, Columbus (J.T.K.) - both in Ohio; Walton Centre for Neurology and Neurosurgery, Liverpool (B.R.F.L.), and Nuffield Department of Clinical Neurosciences, Oxford University, Oxford (C.B., A.V.) - both in the United Kingdom; Unit of Neurology, University of Brasilia, Brasilia (E.D.-T.), the Department of Neurology, Federal University, Rio de Janeiro (M.W.-C.), and the Department of Neurology, Universidade Federal do Parana, Curitiba (L.C.W.) - all in Brazil; the Department of Neurology, Kanazawa University, Kanazawa, Japan (H.Y.); the Department of Neurology, University of Florida, Jacksonville (M.T.P.), and the Department of Neurology, University of Miami, Miami (M.B.) - both in Florida; the Department of Neurology, Augusta University, Augusta (M.H.R.); the Department of Neurology, Medical University of Warsaw, Warsaw, Poland (A.K.-P.); the Department of Neurology, Indiana School of Medicine, Indianapolis (R.M.P.); the Department of Neurology, Leiden University Medical Center, Leiden, the Netherlands (J.J.G.M.V.); the Department of Neurology, Duke University Medical Center, Durham, NC (J.M.M.); the Department of Neurology, University of Kansas Medical Center, Kansas City (R.J.B.); the Department of Neurological Sciences, University of Vermont College of Medicine, Burlington (R.T.); the Division of Extramural Research, National Institutes of Health, National Institute of Neurological Disorders and Stroke, Bethesda, MD (R.C.); the Section of General Thoracic Surgery, Columbia University Medical Center, New York (J.R.S.); the Department of Neurology, University at Buffalo Jacobs School of Medicine and Biomedical Sciences, Buffalo (G.I.W.).'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Sussman', 'Affiliation': 'From the Department of Neurology, University of Alabama at Birmingham, Birmingham (I.L.); the Department of Biostatistics, University of Alabama at Birmingham, Birmingham (H.-C.K., I.B.A., G.R.C., T.M., G.M); the Department of Neurology, George Washington University School of Medicine and Health Sciences, Washington, DC (H.J.K.); the Department of Neurology, Greater Manchester Neuroscience Center, Salford, Greater Manchester, UK (J.S.); the Institute of Pathology, University Medical Center Göttingen, Göttingen (P.S.); the Department of Neurology, McGill University, Montreal (C.H.C.), and the Division of Neurology, University of British Columbia, Vancouver (J. Oger) - both in Canada; the Department of Neurology, University of Chile, Santiago (G.C.); the Division of Neurology, Department of Medicine, University of Cape Town, Cape Town, South Africa (J.M.H.); the Department of Neurosciences, Mental Health and Sensory Organs, Sapienza University of Rome (G.A.), the Department of Neurology, Catholic University, (A.E.) - both in Rome; the Department of Neurology, Johannes Gutenberg University, Mainz, Germany (W.N.); the Department of Neurology, University of Rochester Medical Center, Rochester, New York (E.C.); the Division of Neurology, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand (R.W.); the Department of Neurology, Royal Melbourne Hospital, Victoria, Australia (J.O.K.); the Department of Neurology, University of Southern California, Los Angeles (S.R.B.), and the Department of Neurology, University of California Irvine Medical Center, Orange (T.M.) - both in California; the Department of Neurology, Medical College of Wisconsin, Milwaukee (A.C.B.); the Department of Neurology, Harvard Medical School, Boston (A.A.A.); Nerve and Muscle Center of Texas, Houston (A.I.S.), and the Department of Neurology, University of Texas Health Science Center, San Antonio (C.E.J.) - both in Texas; the Department of Neurology, Case Western Reserve University, Cleveland (B.K.), and the Department of Neurology, Ohio State University Wexner Medical Center, Columbus (J.T.K.) - both in Ohio; Walton Centre for Neurology and Neurosurgery, Liverpool (B.R.F.L.), and Nuffield Department of Clinical Neurosciences, Oxford University, Oxford (C.B., A.V.) - both in the United Kingdom; Unit of Neurology, University of Brasilia, Brasilia (E.D.-T.), the Department of Neurology, Federal University, Rio de Janeiro (M.W.-C.), and the Department of Neurology, Universidade Federal do Parana, Curitiba (L.C.W.) - all in Brazil; the Department of Neurology, Kanazawa University, Kanazawa, Japan (H.Y.); the Department of Neurology, University of Florida, Jacksonville (M.T.P.), and the Department of Neurology, University of Miami, Miami (M.B.) - both in Florida; the Department of Neurology, Augusta University, Augusta (M.H.R.); the Department of Neurology, Medical University of Warsaw, Warsaw, Poland (A.K.-P.); the Department of Neurology, Indiana School of Medicine, Indianapolis (R.M.P.); the Department of Neurology, Leiden University Medical Center, Leiden, the Netherlands (J.J.G.M.V.); the Department of Neurology, Duke University Medical Center, Durham, NC (J.M.M.); the Department of Neurology, University of Kansas Medical Center, Kansas City (R.J.B.); the Department of Neurological Sciences, University of Vermont College of Medicine, Burlington (R.T.); the Division of Extramural Research, National Institutes of Health, National Institute of Neurological Disorders and Stroke, Bethesda, MD (R.C.); the Section of General Thoracic Surgery, Columbia University Medical Center, New York (J.R.S.); the Department of Neurology, University at Buffalo Jacobs School of Medicine and Biomedical Sciences, Buffalo (G.I.W.).'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Ströbel', 'Affiliation': 'From the Department of Neurology, University of Alabama at Birmingham, Birmingham (I.L.); the Department of Biostatistics, University of Alabama at Birmingham, Birmingham (H.-C.K., I.B.A., G.R.C., T.M., G.M); the Department of Neurology, George Washington University School of Medicine and Health Sciences, Washington, DC (H.J.K.); the Department of Neurology, Greater Manchester Neuroscience Center, Salford, Greater Manchester, UK (J.S.); the Institute of Pathology, University Medical Center Göttingen, Göttingen (P.S.); the Department of Neurology, McGill University, Montreal (C.H.C.), and the Division of Neurology, University of British Columbia, Vancouver (J. Oger) - both in Canada; the Department of Neurology, University of Chile, Santiago (G.C.); the Division of Neurology, Department of Medicine, University of Cape Town, Cape Town, South Africa (J.M.H.); the Department of Neurosciences, Mental Health and Sensory Organs, Sapienza University of Rome (G.A.), the Department of Neurology, Catholic University, (A.E.) - both in Rome; the Department of Neurology, Johannes Gutenberg University, Mainz, Germany (W.N.); the Department of Neurology, University of Rochester Medical Center, Rochester, New York (E.C.); the Division of Neurology, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand (R.W.); the Department of Neurology, Royal Melbourne Hospital, Victoria, Australia (J.O.K.); the Department of Neurology, University of Southern California, Los Angeles (S.R.B.), and the Department of Neurology, University of California Irvine Medical Center, Orange (T.M.) - both in California; the Department of Neurology, Medical College of Wisconsin, Milwaukee (A.C.B.); the Department of Neurology, Harvard Medical School, Boston (A.A.A.); Nerve and Muscle Center of Texas, Houston (A.I.S.), and the Department of Neurology, University of Texas Health Science Center, San Antonio (C.E.J.) - both in Texas; the Department of Neurology, Case Western Reserve University, Cleveland (B.K.), and the Department of Neurology, Ohio State University Wexner Medical Center, Columbus (J.T.K.) - both in Ohio; Walton Centre for Neurology and Neurosurgery, Liverpool (B.R.F.L.), and Nuffield Department of Clinical Neurosciences, Oxford University, Oxford (C.B., A.V.) - both in the United Kingdom; Unit of Neurology, University of Brasilia, Brasilia (E.D.-T.), the Department of Neurology, Federal University, Rio de Janeiro (M.W.-C.), and the Department of Neurology, Universidade Federal do Parana, Curitiba (L.C.W.) - all in Brazil; the Department of Neurology, Kanazawa University, Kanazawa, Japan (H.Y.); the Department of Neurology, University of Florida, Jacksonville (M.T.P.), and the Department of Neurology, University of Miami, Miami (M.B.) - both in Florida; the Department of Neurology, Augusta University, Augusta (M.H.R.); the Department of Neurology, Medical University of Warsaw, Warsaw, Poland (A.K.-P.); the Department of Neurology, Indiana School of Medicine, Indianapolis (R.M.P.); the Department of Neurology, Leiden University Medical Center, Leiden, the Netherlands (J.J.G.M.V.); the Department of Neurology, Duke University Medical Center, Durham, NC (J.M.M.); the Department of Neurology, University of Kansas Medical Center, Kansas City (R.J.B.); the Department of Neurological Sciences, University of Vermont College of Medicine, Burlington (R.T.); the Division of Extramural Research, National Institutes of Health, National Institute of Neurological Disorders and Stroke, Bethesda, MD (R.C.); the Section of General Thoracic Surgery, Columbia University Medical Center, New York (J.R.S.); the Department of Neurology, University at Buffalo Jacobs School of Medicine and Biomedical Sciences, Buffalo (G.I.W.).'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Oger', 'Affiliation': 'From the Department of Neurology, University of Alabama at Birmingham, Birmingham (I.L.); the Department of Biostatistics, University of Alabama at Birmingham, Birmingham (H.-C.K., I.B.A., G.R.C., T.M., G.M); the Department of Neurology, George Washington University School of Medicine and Health Sciences, Washington, DC (H.J.K.); the Department of Neurology, Greater Manchester Neuroscience Center, Salford, Greater Manchester, UK (J.S.); the Institute of Pathology, University Medical Center Göttingen, Göttingen (P.S.); the Department of Neurology, McGill University, Montreal (C.H.C.), and the Division of Neurology, University of British Columbia, Vancouver (J. Oger) - both in Canada; the Department of Neurology, University of Chile, Santiago (G.C.); the Division of Neurology, Department of Medicine, University of Cape Town, Cape Town, South Africa (J.M.H.); the Department of Neurosciences, Mental Health and Sensory Organs, Sapienza University of Rome (G.A.), the Department of Neurology, Catholic University, (A.E.) - both in Rome; the Department of Neurology, Johannes Gutenberg University, Mainz, Germany (W.N.); the Department of Neurology, University of Rochester Medical Center, Rochester, New York (E.C.); the Division of Neurology, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand (R.W.); the Department of Neurology, Royal Melbourne Hospital, Victoria, Australia (J.O.K.); the Department of Neurology, University of Southern California, Los Angeles (S.R.B.), and the Department of Neurology, University of California Irvine Medical Center, Orange (T.M.) - both in California; the Department of Neurology, Medical College of Wisconsin, Milwaukee (A.C.B.); the Department of Neurology, Harvard Medical School, Boston (A.A.A.); Nerve and Muscle Center of Texas, Houston (A.I.S.), and the Department of Neurology, University of Texas Health Science Center, San Antonio (C.E.J.) - both in Texas; the Department of Neurology, Case Western Reserve University, Cleveland (B.K.), and the Department of Neurology, Ohio State University Wexner Medical Center, Columbus (J.T.K.) - both in Ohio; Walton Centre for Neurology and Neurosurgery, Liverpool (B.R.F.L.), and Nuffield Department of Clinical Neurosciences, Oxford University, Oxford (C.B., A.V.) - both in the United Kingdom; Unit of Neurology, University of Brasilia, Brasilia (E.D.-T.), the Department of Neurology, Federal University, Rio de Janeiro (M.W.-C.), and the Department of Neurology, Universidade Federal do Parana, Curitiba (L.C.W.) - all in Brazil; the Department of Neurology, Kanazawa University, Kanazawa, Japan (H.Y.); the Department of Neurology, University of Florida, Jacksonville (M.T.P.), and the Department of Neurology, University of Miami, Miami (M.B.) - both in Florida; the Department of Neurology, Augusta University, Augusta (M.H.R.); the Department of Neurology, Medical University of Warsaw, Warsaw, Poland (A.K.-P.); the Department of Neurology, Indiana School of Medicine, Indianapolis (R.M.P.); the Department of Neurology, Leiden University Medical Center, Leiden, the Netherlands (J.J.G.M.V.); the Department of Neurology, Duke University Medical Center, Durham, NC (J.M.M.); the Department of Neurology, University of Kansas Medical Center, Kansas City (R.J.B.); the Department of Neurological Sciences, University of Vermont College of Medicine, Burlington (R.T.); the Division of Extramural Research, National Institutes of Health, National Institute of Neurological Disorders and Stroke, Bethesda, MD (R.C.); the Section of General Thoracic Surgery, Columbia University Medical Center, New York (J.R.S.); the Department of Neurology, University at Buffalo Jacobs School of Medicine and Biomedical Sciences, Buffalo (G.I.W.).'}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Cea', 'Affiliation': 'From the Department of Neurology, University of Alabama at Birmingham, Birmingham (I.L.); the Department of Biostatistics, University of Alabama at Birmingham, Birmingham (H.-C.K., I.B.A., G.R.C., T.M., G.M); the Department of Neurology, George Washington University School of Medicine and Health Sciences, Washington, DC (H.J.K.); the Department of Neurology, Greater Manchester Neuroscience Center, Salford, Greater Manchester, UK (J.S.); the Institute of Pathology, University Medical Center Göttingen, Göttingen (P.S.); the Department of Neurology, McGill University, Montreal (C.H.C.), and the Division of Neurology, University of British Columbia, Vancouver (J. Oger) - both in Canada; the Department of Neurology, University of Chile, Santiago (G.C.); the Division of Neurology, Department of Medicine, University of Cape Town, Cape Town, South Africa (J.M.H.); the Department of Neurosciences, Mental Health and Sensory Organs, Sapienza University of Rome (G.A.), the Department of Neurology, Catholic University, (A.E.) - both in Rome; the Department of Neurology, Johannes Gutenberg University, Mainz, Germany (W.N.); the Department of Neurology, University of Rochester Medical Center, Rochester, New York (E.C.); the Division of Neurology, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand (R.W.); the Department of Neurology, Royal Melbourne Hospital, Victoria, Australia (J.O.K.); the Department of Neurology, University of Southern California, Los Angeles (S.R.B.), and the Department of Neurology, University of California Irvine Medical Center, Orange (T.M.) - both in California; the Department of Neurology, Medical College of Wisconsin, Milwaukee (A.C.B.); the Department of Neurology, Harvard Medical School, Boston (A.A.A.); Nerve and Muscle Center of Texas, Houston (A.I.S.), and the Department of Neurology, University of Texas Health Science Center, San Antonio (C.E.J.) - both in Texas; the Department of Neurology, Case Western Reserve University, Cleveland (B.K.), and the Department of Neurology, Ohio State University Wexner Medical Center, Columbus (J.T.K.) - both in Ohio; Walton Centre for Neurology and Neurosurgery, Liverpool (B.R.F.L.), and Nuffield Department of Clinical Neurosciences, Oxford University, Oxford (C.B., A.V.) - both in the United Kingdom; Unit of Neurology, University of Brasilia, Brasilia (E.D.-T.), the Department of Neurology, Federal University, Rio de Janeiro (M.W.-C.), and the Department of Neurology, Universidade Federal do Parana, Curitiba (L.C.W.) - all in Brazil; the Department of Neurology, Kanazawa University, Kanazawa, Japan (H.Y.); the Department of Neurology, University of Florida, Jacksonville (M.T.P.), and the Department of Neurology, University of Miami, Miami (M.B.) - both in Florida; the Department of Neurology, Augusta University, Augusta (M.H.R.); the Department of Neurology, Medical University of Warsaw, Warsaw, Poland (A.K.-P.); the Department of Neurology, Indiana School of Medicine, Indianapolis (R.M.P.); the Department of Neurology, Leiden University Medical Center, Leiden, the Netherlands (J.J.G.M.V.); the Department of Neurology, Duke University Medical Center, Durham, NC (J.M.M.); the Department of Neurology, University of Kansas Medical Center, Kansas City (R.J.B.); the Department of Neurological Sciences, University of Vermont College of Medicine, Burlington (R.T.); the Division of Extramural Research, National Institutes of Health, National Institute of Neurological Disorders and Stroke, Bethesda, MD (R.C.); the Section of General Thoracic Surgery, Columbia University Medical Center, New York (J.R.S.); the Department of Neurology, University at Buffalo Jacobs School of Medicine and Biomedical Sciences, Buffalo (G.I.W.).'}, {'ForeName': 'Jeannine M', 'Initials': 'JM', 'LastName': 'Heckmann', 'Affiliation': 'From the Department of Neurology, University of Alabama at Birmingham, Birmingham (I.L.); the Department of Biostatistics, University of Alabama at Birmingham, Birmingham (H.-C.K., I.B.A., G.R.C., T.M., G.M); the Department of Neurology, George Washington University School of Medicine and Health Sciences, Washington, DC (H.J.K.); the Department of Neurology, Greater Manchester Neuroscience Center, Salford, Greater Manchester, UK (J.S.); the Institute of Pathology, University Medical Center Göttingen, Göttingen (P.S.); the Department of Neurology, McGill University, Montreal (C.H.C.), and the Division of Neurology, University of British Columbia, Vancouver (J. Oger) - both in Canada; the Department of Neurology, University of Chile, Santiago (G.C.); the Division of Neurology, Department of Medicine, University of Cape Town, Cape Town, South Africa (J.M.H.); the Department of Neurosciences, Mental Health and Sensory Organs, Sapienza University of Rome (G.A.), the Department of Neurology, Catholic University, (A.E.) - both in Rome; the Department of Neurology, Johannes Gutenberg University, Mainz, Germany (W.N.); the Department of Neurology, University of Rochester Medical Center, Rochester, New York (E.C.); the Division of Neurology, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand (R.W.); the Department of Neurology, Royal Melbourne Hospital, Victoria, Australia (J.O.K.); the Department of Neurology, University of Southern California, Los Angeles (S.R.B.), and the Department of Neurology, University of California Irvine Medical Center, Orange (T.M.) - both in California; the Department of Neurology, Medical College of Wisconsin, Milwaukee (A.C.B.); the Department of Neurology, Harvard Medical School, Boston (A.A.A.); Nerve and Muscle Center of Texas, Houston (A.I.S.), and the Department of Neurology, University of Texas Health Science Center, San Antonio (C.E.J.) - both in Texas; the Department of Neurology, Case Western Reserve University, Cleveland (B.K.), and the Department of Neurology, Ohio State University Wexner Medical Center, Columbus (J.T.K.) - both in Ohio; Walton Centre for Neurology and Neurosurgery, Liverpool (B.R.F.L.), and Nuffield Department of Clinical Neurosciences, Oxford University, Oxford (C.B., A.V.) - both in the United Kingdom; Unit of Neurology, University of Brasilia, Brasilia (E.D.-T.), the Department of Neurology, Federal University, Rio de Janeiro (M.W.-C.), and the Department of Neurology, Universidade Federal do Parana, Curitiba (L.C.W.) - all in Brazil; the Department of Neurology, Kanazawa University, Kanazawa, Japan (H.Y.); the Department of Neurology, University of Florida, Jacksonville (M.T.P.), and the Department of Neurology, University of Miami, Miami (M.B.) - both in Florida; the Department of Neurology, Augusta University, Augusta (M.H.R.); the Department of Neurology, Medical University of Warsaw, Warsaw, Poland (A.K.-P.); the Department of Neurology, Indiana School of Medicine, Indianapolis (R.M.P.); the Department of Neurology, Leiden University Medical Center, Leiden, the Netherlands (J.J.G.M.V.); the Department of Neurology, Duke University Medical Center, Durham, NC (J.M.M.); the Department of Neurology, University of Kansas Medical Center, Kansas City (R.J.B.); the Department of Neurological Sciences, University of Vermont College of Medicine, Burlington (R.T.); the Division of Extramural Research, National Institutes of Health, National Institute of Neurological Disorders and Stroke, Bethesda, MD (R.C.); the Section of General Thoracic Surgery, Columbia University Medical Center, New York (J.R.S.); the Department of Neurology, University at Buffalo Jacobs School of Medicine and Biomedical Sciences, Buffalo (G.I.W.).'}, {'ForeName': 'Amelia', 'Initials': 'A', 'LastName': 'Evoli', 'Affiliation': 'From the Department of Neurology, University of Alabama at Birmingham, Birmingham (I.L.); the Department of Biostatistics, University of Alabama at Birmingham, Birmingham (H.-C.K., I.B.A., G.R.C., T.M., G.M); the Department of Neurology, George Washington University School of Medicine and Health Sciences, Washington, DC (H.J.K.); the Department of Neurology, Greater Manchester Neuroscience Center, Salford, Greater Manchester, UK (J.S.); the Institute of Pathology, University Medical Center Göttingen, Göttingen (P.S.); the Department of Neurology, McGill University, Montreal (C.H.C.), and the Division of Neurology, University of British Columbia, Vancouver (J. Oger) - both in Canada; the Department of Neurology, University of Chile, Santiago (G.C.); the Division of Neurology, Department of Medicine, University of Cape Town, Cape Town, South Africa (J.M.H.); the Department of Neurosciences, Mental Health and Sensory Organs, Sapienza University of Rome (G.A.), the Department of Neurology, Catholic University, (A.E.) - both in Rome; the Department of Neurology, Johannes Gutenberg University, Mainz, Germany (W.N.); the Department of Neurology, University of Rochester Medical Center, Rochester, New York (E.C.); the Division of Neurology, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand (R.W.); the Department of Neurology, Royal Melbourne Hospital, Victoria, Australia (J.O.K.); the Department of Neurology, University of Southern California, Los Angeles (S.R.B.), and the Department of Neurology, University of California Irvine Medical Center, Orange (T.M.) - both in California; the Department of Neurology, Medical College of Wisconsin, Milwaukee (A.C.B.); the Department of Neurology, Harvard Medical School, Boston (A.A.A.); Nerve and Muscle Center of Texas, Houston (A.I.S.), and the Department of Neurology, University of Texas Health Science Center, San Antonio (C.E.J.) - both in Texas; the Department of Neurology, Case Western Reserve University, Cleveland (B.K.), and the Department of Neurology, Ohio State University Wexner Medical Center, Columbus (J.T.K.) - both in Ohio; Walton Centre for Neurology and Neurosurgery, Liverpool (B.R.F.L.), and Nuffield Department of Clinical Neurosciences, Oxford University, Oxford (C.B., A.V.) - both in the United Kingdom; Unit of Neurology, University of Brasilia, Brasilia (E.D.-T.), the Department of Neurology, Federal University, Rio de Janeiro (M.W.-C.), and the Department of Neurology, Universidade Federal do Parana, Curitiba (L.C.W.) - all in Brazil; the Department of Neurology, Kanazawa University, Kanazawa, Japan (H.Y.); the Department of Neurology, University of Florida, Jacksonville (M.T.P.), and the Department of Neurology, University of Miami, Miami (M.B.) - both in Florida; the Department of Neurology, Augusta University, Augusta (M.H.R.); the Department of Neurology, Medical University of Warsaw, Warsaw, Poland (A.K.-P.); the Department of Neurology, Indiana School of Medicine, Indianapolis (R.M.P.); the Department of Neurology, Leiden University Medical Center, Leiden, the Netherlands (J.J.G.M.V.); the Department of Neurology, Duke University Medical Center, Durham, NC (J.M.M.); the Department of Neurology, University of Kansas Medical Center, Kansas City (R.J.B.); the Department of Neurological Sciences, University of Vermont College of Medicine, Burlington (R.T.); the Division of Extramural Research, National Institutes of Health, National Institute of Neurological Disorders and Stroke, Bethesda, MD (R.C.); the Section of General Thoracic Surgery, Columbia University Medical Center, New York (J.R.S.); the Department of Neurology, University at Buffalo Jacobs School of Medicine and Biomedical Sciences, Buffalo (G.I.W.).'}, {'ForeName': 'Wilfred', 'Initials': 'W', 'LastName': 'Nix', 'Affiliation': 'From the Department of Neurology, University of Alabama at Birmingham, Birmingham (I.L.); the Department of Biostatistics, University of Alabama at Birmingham, Birmingham (H.-C.K., I.B.A., G.R.C., T.M., G.M); the Department of Neurology, George Washington University School of Medicine and Health Sciences, Washington, DC (H.J.K.); the Department of Neurology, Greater Manchester Neuroscience Center, Salford, Greater Manchester, UK (J.S.); the Institute of Pathology, University Medical Center Göttingen, Göttingen (P.S.); the Department of Neurology, McGill University, Montreal (C.H.C.), and the Division of Neurology, University of British Columbia, Vancouver (J. Oger) - both in Canada; the Department of Neurology, University of Chile, Santiago (G.C.); the Division of Neurology, Department of Medicine, University of Cape Town, Cape Town, South Africa (J.M.H.); the Department of Neurosciences, Mental Health and Sensory Organs, Sapienza University of Rome (G.A.), the Department of Neurology, Catholic University, (A.E.) - both in Rome; the Department of Neurology, Johannes Gutenberg University, Mainz, Germany (W.N.); the Department of Neurology, University of Rochester Medical Center, Rochester, New York (E.C.); the Division of Neurology, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand (R.W.); the Department of Neurology, Royal Melbourne Hospital, Victoria, Australia (J.O.K.); the Department of Neurology, University of Southern California, Los Angeles (S.R.B.), and the Department of Neurology, University of California Irvine Medical Center, Orange (T.M.) - both in California; the Department of Neurology, Medical College of Wisconsin, Milwaukee (A.C.B.); the Department of Neurology, Harvard Medical School, Boston (A.A.A.); Nerve and Muscle Center of Texas, Houston (A.I.S.), and the Department of Neurology, University of Texas Health Science Center, San Antonio (C.E.J.) - both in Texas; the Department of Neurology, Case Western Reserve University, Cleveland (B.K.), and the Department of Neurology, Ohio State University Wexner Medical Center, Columbus (J.T.K.) - both in Ohio; Walton Centre for Neurology and Neurosurgery, Liverpool (B.R.F.L.), and Nuffield Department of Clinical Neurosciences, Oxford University, Oxford (C.B., A.V.) - both in the United Kingdom; Unit of Neurology, University of Brasilia, Brasilia (E.D.-T.), the Department of Neurology, Federal University, Rio de Janeiro (M.W.-C.), and the Department of Neurology, Universidade Federal do Parana, Curitiba (L.C.W.) - all in Brazil; the Department of Neurology, Kanazawa University, Kanazawa, Japan (H.Y.); the Department of Neurology, University of Florida, Jacksonville (M.T.P.), and the Department of Neurology, University of Miami, Miami (M.B.) - both in Florida; the Department of Neurology, Augusta University, Augusta (M.H.R.); the Department of Neurology, Medical University of Warsaw, Warsaw, Poland (A.K.-P.); the Department of Neurology, Indiana School of Medicine, Indianapolis (R.M.P.); the Department of Neurology, Leiden University Medical Center, Leiden, the Netherlands (J.J.G.M.V.); the Department of Neurology, Duke University Medical Center, Durham, NC (J.M.M.); the Department of Neurology, University of Kansas Medical Center, Kansas City (R.J.B.); the Department of Neurological Sciences, University of Vermont College of Medicine, Burlington (R.T.); the Division of Extramural Research, National Institutes of Health, National Institute of Neurological Disorders and Stroke, Bethesda, MD (R.C.); the Section of General Thoracic Surgery, Columbia University Medical Center, New York (J.R.S.); the Department of Neurology, University at Buffalo Jacobs School of Medicine and Biomedical Sciences, Buffalo (G.I.W.).'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Ciafaloni', 'Affiliation': 'From the Department of Neurology, University of Alabama at Birmingham, Birmingham (I.L.); the Department of Biostatistics, University of Alabama at Birmingham, Birmingham (H.-C.K., I.B.A., G.R.C., T.M., G.M); the Department of Neurology, George Washington University School of Medicine and Health Sciences, Washington, DC (H.J.K.); the Department of Neurology, Greater Manchester Neuroscience Center, Salford, Greater Manchester, UK (J.S.); the Institute of Pathology, University Medical Center Göttingen, Göttingen (P.S.); the Department of Neurology, McGill University, Montreal (C.H.C.), and the Division of Neurology, University of British Columbia, Vancouver (J. Oger) - both in Canada; the Department of Neurology, University of Chile, Santiago (G.C.); the Division of Neurology, Department of Medicine, University of Cape Town, Cape Town, South Africa (J.M.H.); the Department of Neurosciences, Mental Health and Sensory Organs, Sapienza University of Rome (G.A.), the Department of Neurology, Catholic University, (A.E.) - both in Rome; the Department of Neurology, Johannes Gutenberg University, Mainz, Germany (W.N.); the Department of Neurology, University of Rochester Medical Center, Rochester, New York (E.C.); the Division of Neurology, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand (R.W.); the Department of Neurology, Royal Melbourne Hospital, Victoria, Australia (J.O.K.); the Department of Neurology, University of Southern California, Los Angeles (S.R.B.), and the Department of Neurology, University of California Irvine Medical Center, Orange (T.M.) - both in California; the Department of Neurology, Medical College of Wisconsin, Milwaukee (A.C.B.); the Department of Neurology, Harvard Medical School, Boston (A.A.A.); Nerve and Muscle Center of Texas, Houston (A.I.S.), and the Department of Neurology, University of Texas Health Science Center, San Antonio (C.E.J.) - both in Texas; the Department of Neurology, Case Western Reserve University, Cleveland (B.K.), and the Department of Neurology, Ohio State University Wexner Medical Center, Columbus (J.T.K.) - both in Ohio; Walton Centre for Neurology and Neurosurgery, Liverpool (B.R.F.L.), and Nuffield Department of Clinical Neurosciences, Oxford University, Oxford (C.B., A.V.) - both in the United Kingdom; Unit of Neurology, University of Brasilia, Brasilia (E.D.-T.), the Department of Neurology, Federal University, Rio de Janeiro (M.W.-C.), and the Department of Neurology, Universidade Federal do Parana, Curitiba (L.C.W.) - all in Brazil; the Department of Neurology, Kanazawa University, Kanazawa, Japan (H.Y.); the Department of Neurology, University of Florida, Jacksonville (M.T.P.), and the Department of Neurology, University of Miami, Miami (M.B.) - both in Florida; the Department of Neurology, Augusta University, Augusta (M.H.R.); the Department of Neurology, Medical University of Warsaw, Warsaw, Poland (A.K.-P.); the Department of Neurology, Indiana School of Medicine, Indianapolis (R.M.P.); the Department of Neurology, Leiden University Medical Center, Leiden, the Netherlands (J.J.G.M.V.); the Department of Neurology, Duke University Medical Center, Durham, NC (J.M.M.); the Department of Neurology, University of Kansas Medical Center, Kansas City (R.J.B.); the Department of Neurological Sciences, University of Vermont College of Medicine, Burlington (R.T.); the Division of Extramural Research, National Institutes of Health, National Institute of Neurological Disorders and Stroke, Bethesda, MD (R.C.); the Section of General Thoracic Surgery, Columbia University Medical Center, New York (J.R.S.); the Department of Neurology, University at Buffalo Jacobs School of Medicine and Biomedical Sciences, Buffalo (G.I.W.).'}, {'ForeName': 'Giovanni', 'Initials': 'G', 'LastName': 'Antonini', 'Affiliation': 'From the Department of Neurology, University of Alabama at Birmingham, Birmingham (I.L.); the Department of Biostatistics, University of Alabama at Birmingham, Birmingham (H.-C.K., I.B.A., G.R.C., T.M., G.M); the Department of Neurology, George Washington University School of Medicine and Health Sciences, Washington, DC (H.J.K.); the Department of Neurology, Greater Manchester Neuroscience Center, Salford, Greater Manchester, UK (J.S.); the Institute of Pathology, University Medical Center Göttingen, Göttingen (P.S.); the Department of Neurology, McGill University, Montreal (C.H.C.), and the Division of Neurology, University of British Columbia, Vancouver (J. Oger) - both in Canada; the Department of Neurology, University of Chile, Santiago (G.C.); the Division of Neurology, Department of Medicine, University of Cape Town, Cape Town, South Africa (J.M.H.); the Department of Neurosciences, Mental Health and Sensory Organs, Sapienza University of Rome (G.A.), the Department of Neurology, Catholic University, (A.E.) - both in Rome; the Department of Neurology, Johannes Gutenberg University, Mainz, Germany (W.N.); the Department of Neurology, University of Rochester Medical Center, Rochester, New York (E.C.); the Division of Neurology, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand (R.W.); the Department of Neurology, Royal Melbourne Hospital, Victoria, Australia (J.O.K.); the Department of Neurology, University of Southern California, Los Angeles (S.R.B.), and the Department of Neurology, University of California Irvine Medical Center, Orange (T.M.) - both in California; the Department of Neurology, Medical College of Wisconsin, Milwaukee (A.C.B.); the Department of Neurology, Harvard Medical School, Boston (A.A.A.); Nerve and Muscle Center of Texas, Houston (A.I.S.), and the Department of Neurology, University of Texas Health Science Center, San Antonio (C.E.J.) - both in Texas; the Department of Neurology, Case Western Reserve University, Cleveland (B.K.), and the Department of Neurology, Ohio State University Wexner Medical Center, Columbus (J.T.K.) - both in Ohio; Walton Centre for Neurology and Neurosurgery, Liverpool (B.R.F.L.), and Nuffield Department of Clinical Neurosciences, Oxford University, Oxford (C.B., A.V.) - both in the United Kingdom; Unit of Neurology, University of Brasilia, Brasilia (E.D.-T.), the Department of Neurology, Federal University, Rio de Janeiro (M.W.-C.), and the Department of Neurology, Universidade Federal do Parana, Curitiba (L.C.W.) - all in Brazil; the Department of Neurology, Kanazawa University, Kanazawa, Japan (H.Y.); the Department of Neurology, University of Florida, Jacksonville (M.T.P.), and the Department of Neurology, University of Miami, Miami (M.B.) - both in Florida; the Department of Neurology, Augusta University, Augusta (M.H.R.); the Department of Neurology, Medical University of Warsaw, Warsaw, Poland (A.K.-P.); the Department of Neurology, Indiana School of Medicine, Indianapolis (R.M.P.); the Department of Neurology, Leiden University Medical Center, Leiden, the Netherlands (J.J.G.M.V.); the Department of Neurology, Duke University Medical Center, Durham, NC (J.M.M.); the Department of Neurology, University of Kansas Medical Center, Kansas City (R.J.B.); the Department of Neurological Sciences, University of Vermont College of Medicine, Burlington (R.T.); the Division of Extramural Research, National Institutes of Health, National Institute of Neurological Disorders and Stroke, Bethesda, MD (R.C.); the Section of General Thoracic Surgery, Columbia University Medical Center, New York (J.R.S.); the Department of Neurology, University at Buffalo Jacobs School of Medicine and Biomedical Sciences, Buffalo (G.I.W.).'}, {'ForeName': 'Rawiphan', 'Initials': 'R', 'LastName': 'Witoonpanich', 'Affiliation': 'From the Department of Neurology, University of Alabama at Birmingham, Birmingham (I.L.); the Department of Biostatistics, University of Alabama at Birmingham, Birmingham (H.-C.K., I.B.A., G.R.C., T.M., G.M); the Department of Neurology, George Washington University School of Medicine and Health Sciences, Washington, DC (H.J.K.); the Department of Neurology, Greater Manchester Neuroscience Center, Salford, Greater Manchester, UK (J.S.); the Institute of Pathology, University Medical Center Göttingen, Göttingen (P.S.); the Department of Neurology, McGill University, Montreal (C.H.C.), and the Division of Neurology, University of British Columbia, Vancouver (J. Oger) - both in Canada; the Department of Neurology, University of Chile, Santiago (G.C.); the Division of Neurology, Department of Medicine, University of Cape Town, Cape Town, South Africa (J.M.H.); the Department of Neurosciences, Mental Health and Sensory Organs, Sapienza University of Rome (G.A.), the Department of Neurology, Catholic University, (A.E.) - both in Rome; the Department of Neurology, Johannes Gutenberg University, Mainz, Germany (W.N.); the Department of Neurology, University of Rochester Medical Center, Rochester, New York (E.C.); the Division of Neurology, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand (R.W.); the Department of Neurology, Royal Melbourne Hospital, Victoria, Australia (J.O.K.); the Department of Neurology, University of Southern California, Los Angeles (S.R.B.), and the Department of Neurology, University of California Irvine Medical Center, Orange (T.M.) - both in California; the Department of Neurology, Medical College of Wisconsin, Milwaukee (A.C.B.); the Department of Neurology, Harvard Medical School, Boston (A.A.A.); Nerve and Muscle Center of Texas, Houston (A.I.S.), and the Department of Neurology, University of Texas Health Science Center, San Antonio (C.E.J.) - both in Texas; the Department of Neurology, Case Western Reserve University, Cleveland (B.K.), and the Department of Neurology, Ohio State University Wexner Medical Center, Columbus (J.T.K.) - both in Ohio; Walton Centre for Neurology and Neurosurgery, Liverpool (B.R.F.L.), and Nuffield Department of Clinical Neurosciences, Oxford University, Oxford (C.B., A.V.) - both in the United Kingdom; Unit of Neurology, University of Brasilia, Brasilia (E.D.-T.), the Department of Neurology, Federal University, Rio de Janeiro (M.W.-C.), and the Department of Neurology, Universidade Federal do Parana, Curitiba (L.C.W.) - all in Brazil; the Department of Neurology, Kanazawa University, Kanazawa, Japan (H.Y.); the Department of Neurology, University of Florida, Jacksonville (M.T.P.), and the Department of Neurology, University of Miami, Miami (M.B.) - both in Florida; the Department of Neurology, Augusta University, Augusta (M.H.R.); the Department of Neurology, Medical University of Warsaw, Warsaw, Poland (A.K.-P.); the Department of Neurology, Indiana School of Medicine, Indianapolis (R.M.P.); the Department of Neurology, Leiden University Medical Center, Leiden, the Netherlands (J.J.G.M.V.); the Department of Neurology, Duke University Medical Center, Durham, NC (J.M.M.); the Department of Neurology, University of Kansas Medical Center, Kansas City (R.J.B.); the Department of Neurological Sciences, University of Vermont College of Medicine, Burlington (R.T.); the Division of Extramural Research, National Institutes of Health, National Institute of Neurological Disorders and Stroke, Bethesda, MD (R.C.); the Section of General Thoracic Surgery, Columbia University Medical Center, New York (J.R.S.); the Department of Neurology, University at Buffalo Jacobs School of Medicine and Biomedical Sciences, Buffalo (G.I.W.).'}, {'ForeName': 'John O', 'Initials': 'JO', 'LastName': 'King', 'Affiliation': 'From the Department of Neurology, University of Alabama at Birmingham, Birmingham (I.L.); the Department of Biostatistics, University of Alabama at Birmingham, Birmingham (H.-C.K., I.B.A., G.R.C., T.M., G.M); the Department of Neurology, George Washington University School of Medicine and Health Sciences, Washington, DC (H.J.K.); the Department of Neurology, Greater Manchester Neuroscience Center, Salford, Greater Manchester, UK (J.S.); the Institute of Pathology, University Medical Center Göttingen, Göttingen (P.S.); the Department of Neurology, McGill University, Montreal (C.H.C.), and the Division of Neurology, University of British Columbia, Vancouver (J. Oger) - both in Canada; the Department of Neurology, University of Chile, Santiago (G.C.); the Division of Neurology, Department of Medicine, University of Cape Town, Cape Town, South Africa (J.M.H.); the Department of Neurosciences, Mental Health and Sensory Organs, Sapienza University of Rome (G.A.), the Department of Neurology, Catholic University, (A.E.) - both in Rome; the Department of Neurology, Johannes Gutenberg University, Mainz, Germany (W.N.); the Department of Neurology, University of Rochester Medical Center, Rochester, New York (E.C.); the Division of Neurology, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand (R.W.); the Department of Neurology, Royal Melbourne Hospital, Victoria, Australia (J.O.K.); the Department of Neurology, University of Southern California, Los Angeles (S.R.B.), and the Department of Neurology, University of California Irvine Medical Center, Orange (T.M.) - both in California; the Department of Neurology, Medical College of Wisconsin, Milwaukee (A.C.B.); the Department of Neurology, Harvard Medical School, Boston (A.A.A.); Nerve and Muscle Center of Texas, Houston (A.I.S.), and the Department of Neurology, University of Texas Health Science Center, San Antonio (C.E.J.) - both in Texas; the Department of Neurology, Case Western Reserve University, Cleveland (B.K.), and the Department of Neurology, Ohio State University Wexner Medical Center, Columbus (J.T.K.) - both in Ohio; Walton Centre for Neurology and Neurosurgery, Liverpool (B.R.F.L.), and Nuffield Department of Clinical Neurosciences, Oxford University, Oxford (C.B., A.V.) - both in the United Kingdom; Unit of Neurology, University of Brasilia, Brasilia (E.D.-T.), the Department of Neurology, Federal University, Rio de Janeiro (M.W.-C.), and the Department of Neurology, Universidade Federal do Parana, Curitiba (L.C.W.) - all in Brazil; the Department of Neurology, Kanazawa University, Kanazawa, Japan (H.Y.); the Department of Neurology, University of Florida, Jacksonville (M.T.P.), and the Department of Neurology, University of Miami, Miami (M.B.) - both in Florida; the Department of Neurology, Augusta University, Augusta (M.H.R.); the Department of Neurology, Medical University of Warsaw, Warsaw, Poland (A.K.-P.); the Department of Neurology, Indiana School of Medicine, Indianapolis (R.M.P.); the Department of Neurology, Leiden University Medical Center, Leiden, the Netherlands (J.J.G.M.V.); the Department of Neurology, Duke University Medical Center, Durham, NC (J.M.M.); the Department of Neurology, University of Kansas Medical Center, Kansas City (R.J.B.); the Department of Neurological Sciences, University of Vermont College of Medicine, Burlington (R.T.); the Division of Extramural Research, National Institutes of Health, National Institute of Neurological Disorders and Stroke, Bethesda, MD (R.C.); the Section of General Thoracic Surgery, Columbia University Medical Center, New York (J.R.S.); the Department of Neurology, University at Buffalo Jacobs School of Medicine and Biomedical Sciences, Buffalo (G.I.W.).'}, {'ForeName': 'Said R', 'Initials': 'SR', 'LastName': 'Beydoun', 'Affiliation': 'From the Department of Neurology, University of Alabama at Birmingham, Birmingham (I.L.); the Department of Biostatistics, University of Alabama at Birmingham, Birmingham (H.-C.K., I.B.A., G.R.C., T.M., G.M); the Department of Neurology, George Washington University School of Medicine and Health Sciences, Washington, DC (H.J.K.); the Department of Neurology, Greater Manchester Neuroscience Center, Salford, Greater Manchester, UK (J.S.); the Institute of Pathology, University Medical Center Göttingen, Göttingen (P.S.); the Department of Neurology, McGill University, Montreal (C.H.C.), and the Division of Neurology, University of British Columbia, Vancouver (J. Oger) - both in Canada; the Department of Neurology, University of Chile, Santiago (G.C.); the Division of Neurology, Department of Medicine, University of Cape Town, Cape Town, South Africa (J.M.H.); the Department of Neurosciences, Mental Health and Sensory Organs, Sapienza University of Rome (G.A.), the Department of Neurology, Catholic University, (A.E.) - both in Rome; the Department of Neurology, Johannes Gutenberg University, Mainz, Germany (W.N.); the Department of Neurology, University of Rochester Medical Center, Rochester, New York (E.C.); the Division of Neurology, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand (R.W.); the Department of Neurology, Royal Melbourne Hospital, Victoria, Australia (J.O.K.); the Department of Neurology, University of Southern California, Los Angeles (S.R.B.), and the Department of Neurology, University of California Irvine Medical Center, Orange (T.M.) - both in California; the Department of Neurology, Medical College of Wisconsin, Milwaukee (A.C.B.); the Department of Neurology, Harvard Medical School, Boston (A.A.A.); Nerve and Muscle Center of Texas, Houston (A.I.S.), and the Department of Neurology, University of Texas Health Science Center, San Antonio (C.E.J.) - both in Texas; the Department of Neurology, Case Western Reserve University, Cleveland (B.K.), and the Department of Neurology, Ohio State University Wexner Medical Center, Columbus (J.T.K.) - both in Ohio; Walton Centre for Neurology and Neurosurgery, Liverpool (B.R.F.L.), and Nuffield Department of Clinical Neurosciences, Oxford University, Oxford (C.B., A.V.) - both in the United Kingdom; Unit of Neurology, University of Brasilia, Brasilia (E.D.-T.), the Department of Neurology, Federal University, Rio de Janeiro (M.W.-C.), and the Department of Neurology, Universidade Federal do Parana, Curitiba (L.C.W.) - all in Brazil; the Department of Neurology, Kanazawa University, Kanazawa, Japan (H.Y.); the Department of Neurology, University of Florida, Jacksonville (M.T.P.), and the Department of Neurology, University of Miami, Miami (M.B.) - both in Florida; the Department of Neurology, Augusta University, Augusta (M.H.R.); the Department of Neurology, Medical University of Warsaw, Warsaw, Poland (A.K.-P.); the Department of Neurology, Indiana School of Medicine, Indianapolis (R.M.P.); the Department of Neurology, Leiden University Medical Center, Leiden, the Netherlands (J.J.G.M.V.); the Department of Neurology, Duke University Medical Center, Durham, NC (J.M.M.); the Department of Neurology, University of Kansas Medical Center, Kansas City (R.J.B.); the Department of Neurological Sciences, University of Vermont College of Medicine, Burlington (R.T.); the Division of Extramural Research, National Institutes of Health, National Institute of Neurological Disorders and Stroke, Bethesda, MD (R.C.); the Section of General Thoracic Surgery, Columbia University Medical Center, New York (J.R.S.); the Department of Neurology, University at Buffalo Jacobs School of Medicine and Biomedical Sciences, Buffalo (G.I.W.).'}, {'ForeName': 'Colin H', 'Initials': 'CH', 'LastName': 'Chalk', 'Affiliation': 'From the Department of Neurology, University of Alabama at Birmingham, Birmingham (I.L.); the Department of Biostatistics, University of Alabama at Birmingham, Birmingham (H.-C.K., I.B.A., G.R.C., T.M., G.M); the Department of Neurology, George Washington University School of Medicine and Health Sciences, Washington, DC (H.J.K.); the Department of Neurology, Greater Manchester Neuroscience Center, Salford, Greater Manchester, UK (J.S.); the Institute of Pathology, University Medical Center Göttingen, Göttingen (P.S.); the Department of Neurology, McGill University, Montreal (C.H.C.), and the Division of Neurology, University of British Columbia, Vancouver (J. Oger) - both in Canada; the Department of Neurology, University of Chile, Santiago (G.C.); the Division of Neurology, Department of Medicine, University of Cape Town, Cape Town, South Africa (J.M.H.); the Department of Neurosciences, Mental Health and Sensory Organs, Sapienza University of Rome (G.A.), the Department of Neurology, Catholic University, (A.E.) - both in Rome; the Department of Neurology, Johannes Gutenberg University, Mainz, Germany (W.N.); the Department of Neurology, University of Rochester Medical Center, Rochester, New York (E.C.); the Division of Neurology, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand (R.W.); the Department of Neurology, Royal Melbourne Hospital, Victoria, Australia (J.O.K.); the Department of Neurology, University of Southern California, Los Angeles (S.R.B.), and the Department of Neurology, University of California Irvine Medical Center, Orange (T.M.) - both in California; the Department of Neurology, Medical College of Wisconsin, Milwaukee (A.C.B.); the Department of Neurology, Harvard Medical School, Boston (A.A.A.); Nerve and Muscle Center of Texas, Houston (A.I.S.), and the Department of Neurology, University of Texas Health Science Center, San Antonio (C.E.J.) - both in Texas; the Department of Neurology, Case Western Reserve University, Cleveland (B.K.), and the Department of Neurology, Ohio State University Wexner Medical Center, Columbus (J.T.K.) - both in Ohio; Walton Centre for Neurology and Neurosurgery, Liverpool (B.R.F.L.), and Nuffield Department of Clinical Neurosciences, Oxford University, Oxford (C.B., A.V.) - both in the United Kingdom; Unit of Neurology, University of Brasilia, Brasilia (E.D.-T.), the Department of Neurology, Federal University, Rio de Janeiro (M.W.-C.), and the Department of Neurology, Universidade Federal do Parana, Curitiba (L.C.W.) - all in Brazil; the Department of Neurology, Kanazawa University, Kanazawa, Japan (H.Y.); the Department of Neurology, University of Florida, Jacksonville (M.T.P.), and the Department of Neurology, University of Miami, Miami (M.B.) - both in Florida; the Department of Neurology, Augusta University, Augusta (M.H.R.); the Department of Neurology, Medical University of Warsaw, Warsaw, Poland (A.K.-P.); the Department of Neurology, Indiana School of Medicine, Indianapolis (R.M.P.); the Department of Neurology, Leiden University Medical Center, Leiden, the Netherlands (J.J.G.M.V.); the Department of Neurology, Duke University Medical Center, Durham, NC (J.M.M.); the Department of Neurology, University of Kansas Medical Center, Kansas City (R.J.B.); the Department of Neurological Sciences, University of Vermont College of Medicine, Burlington (R.T.); the Division of Extramural Research, National Institutes of Health, National Institute of Neurological Disorders and Stroke, Bethesda, MD (R.C.); the Section of General Thoracic Surgery, Columbia University Medical Center, New York (J.R.S.); the Department of Neurology, University at Buffalo Jacobs School of Medicine and Biomedical Sciences, Buffalo (G.I.W.).'}, {'ForeName': 'Alexandru C', 'Initials': 'AC', 'LastName': 'Barboi', 'Affiliation': 'From the Department of Neurology, University of Alabama at Birmingham, Birmingham (I.L.); the Department of Biostatistics, University of Alabama at Birmingham, Birmingham (H.-C.K., I.B.A., G.R.C., T.M., G.M); the Department of Neurology, George Washington University School of Medicine and Health Sciences, Washington, DC (H.J.K.); the Department of Neurology, Greater Manchester Neuroscience Center, Salford, Greater Manchester, UK (J.S.); the Institute of Pathology, University Medical Center Göttingen, Göttingen (P.S.); the Department of Neurology, McGill University, Montreal (C.H.C.), and the Division of Neurology, University of British Columbia, Vancouver (J. Oger) - both in Canada; the Department of Neurology, University of Chile, Santiago (G.C.); the Division of Neurology, Department of Medicine, University of Cape Town, Cape Town, South Africa (J.M.H.); the Department of Neurosciences, Mental Health and Sensory Organs, Sapienza University of Rome (G.A.), the Department of Neurology, Catholic University, (A.E.) - both in Rome; the Department of Neurology, Johannes Gutenberg University, Mainz, Germany (W.N.); the Department of Neurology, University of Rochester Medical Center, Rochester, New York (E.C.); the Division of Neurology, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand (R.W.); the Department of Neurology, Royal Melbourne Hospital, Victoria, Australia (J.O.K.); the Department of Neurology, University of Southern California, Los Angeles (S.R.B.), and the Department of Neurology, University of California Irvine Medical Center, Orange (T.M.) - both in California; the Department of Neurology, Medical College of Wisconsin, Milwaukee (A.C.B.); the Department of Neurology, Harvard Medical School, Boston (A.A.A.); Nerve and Muscle Center of Texas, Houston (A.I.S.), and the Department of Neurology, University of Texas Health Science Center, San Antonio (C.E.J.) - both in Texas; the Department of Neurology, Case Western Reserve University, Cleveland (B.K.), and the Department of Neurology, Ohio State University Wexner Medical Center, Columbus (J.T.K.) - both in Ohio; Walton Centre for Neurology and Neurosurgery, Liverpool (B.R.F.L.), and Nuffield Department of Clinical Neurosciences, Oxford University, Oxford (C.B., A.V.) - both in the United Kingdom; Unit of Neurology, University of Brasilia, Brasilia (E.D.-T.), the Department of Neurology, Federal University, Rio de Janeiro (M.W.-C.), and the Department of Neurology, Universidade Federal do Parana, Curitiba (L.C.W.) - all in Brazil; the Department of Neurology, Kanazawa University, Kanazawa, Japan (H.Y.); the Department of Neurology, University of Florida, Jacksonville (M.T.P.), and the Department of Neurology, University of Miami, Miami (M.B.) - both in Florida; the Department of Neurology, Augusta University, Augusta (M.H.R.); the Department of Neurology, Medical University of Warsaw, Warsaw, Poland (A.K.-P.); the Department of Neurology, Indiana School of Medicine, Indianapolis (R.M.P.); the Department of Neurology, Leiden University Medical Center, Leiden, the Netherlands (J.J.G.M.V.); the Department of Neurology, Duke University Medical Center, Durham, NC (J.M.M.); the Department of Neurology, University of Kansas Medical Center, Kansas City (R.J.B.); the Department of Neurological Sciences, University of Vermont College of Medicine, Burlington (R.T.); the Division of Extramural Research, National Institutes of Health, National Institute of Neurological Disorders and Stroke, Bethesda, MD (R.C.); the Section of General Thoracic Surgery, Columbia University Medical Center, New York (J.R.S.); the Department of Neurology, University at Buffalo Jacobs School of Medicine and Biomedical Sciences, Buffalo (G.I.W.).'}, {'ForeName': 'Anthony A', 'Initials': 'AA', 'LastName': 'Amato', 'Affiliation': 'From the Department of Neurology, University of Alabama at Birmingham, Birmingham (I.L.); the Department of Biostatistics, University of Alabama at Birmingham, Birmingham (H.-C.K., I.B.A., G.R.C., T.M., G.M); the Department of Neurology, George Washington University School of Medicine and Health Sciences, Washington, DC (H.J.K.); the Department of Neurology, Greater Manchester Neuroscience Center, Salford, Greater Manchester, UK (J.S.); the Institute of Pathology, University Medical Center Göttingen, Göttingen (P.S.); the Department of Neurology, McGill University, Montreal (C.H.C.), and the Division of Neurology, University of British Columbia, Vancouver (J. Oger) - both in Canada; the Department of Neurology, University of Chile, Santiago (G.C.); the Division of Neurology, Department of Medicine, University of Cape Town, Cape Town, South Africa (J.M.H.); the Department of Neurosciences, Mental Health and Sensory Organs, Sapienza University of Rome (G.A.), the Department of Neurology, Catholic University, (A.E.) - both in Rome; the Department of Neurology, Johannes Gutenberg University, Mainz, Germany (W.N.); the Department of Neurology, University of Rochester Medical Center, Rochester, New York (E.C.); the Division of Neurology, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand (R.W.); the Department of Neurology, Royal Melbourne Hospital, Victoria, Australia (J.O.K.); the Department of Neurology, University of Southern California, Los Angeles (S.R.B.), and the Department of Neurology, University of California Irvine Medical Center, Orange (T.M.) - both in California; the Department of Neurology, Medical College of Wisconsin, Milwaukee (A.C.B.); the Department of Neurology, Harvard Medical School, Boston (A.A.A.); Nerve and Muscle Center of Texas, Houston (A.I.S.), and the Department of Neurology, University of Texas Health Science Center, San Antonio (C.E.J.) - both in Texas; the Department of Neurology, Case Western Reserve University, Cleveland (B.K.), and the Department of Neurology, Ohio State University Wexner Medical Center, Columbus (J.T.K.) - both in Ohio; Walton Centre for Neurology and Neurosurgery, Liverpool (B.R.F.L.), and Nuffield Department of Clinical Neurosciences, Oxford University, Oxford (C.B., A.V.) - both in the United Kingdom; Unit of Neurology, University of Brasilia, Brasilia (E.D.-T.), the Department of Neurology, Federal University, Rio de Janeiro (M.W.-C.), and the Department of Neurology, Universidade Federal do Parana, Curitiba (L.C.W.) - all in Brazil; the Department of Neurology, Kanazawa University, Kanazawa, Japan (H.Y.); the Department of Neurology, University of Florida, Jacksonville (M.T.P.), and the Department of Neurology, University of Miami, Miami (M.B.) - both in Florida; the Department of Neurology, Augusta University, Augusta (M.H.R.); the Department of Neurology, Medical University of Warsaw, Warsaw, Poland (A.K.-P.); the Department of Neurology, Indiana School of Medicine, Indianapolis (R.M.P.); the Department of Neurology, Leiden University Medical Center, Leiden, the Netherlands (J.J.G.M.V.); the Department of Neurology, Duke University Medical Center, Durham, NC (J.M.M.); the Department of Neurology, University of Kansas Medical Center, Kansas City (R.J.B.); the Department of Neurological Sciences, University of Vermont College of Medicine, Burlington (R.T.); the Division of Extramural Research, National Institutes of Health, National Institute of Neurological Disorders and Stroke, Bethesda, MD (R.C.); the Section of General Thoracic Surgery, Columbia University Medical Center, New York (J.R.S.); the Department of Neurology, University at Buffalo Jacobs School of Medicine and Biomedical Sciences, Buffalo (G.I.W.).'}, {'ForeName': 'Aziz I', 'Initials': 'AI', 'LastName': 'Shaibani', 'Affiliation': 'From the Department of Neurology, University of Alabama at Birmingham, Birmingham (I.L.); the Department of Biostatistics, University of Alabama at Birmingham, Birmingham (H.-C.K., I.B.A., G.R.C., T.M., G.M); the Department of Neurology, George Washington University School of Medicine and Health Sciences, Washington, DC (H.J.K.); the Department of Neurology, Greater Manchester Neuroscience Center, Salford, Greater Manchester, UK (J.S.); the Institute of Pathology, University Medical Center Göttingen, Göttingen (P.S.); the Department of Neurology, McGill University, Montreal (C.H.C.), and the Division of Neurology, University of British Columbia, Vancouver (J. Oger) - both in Canada; the Department of Neurology, University of Chile, Santiago (G.C.); the Division of Neurology, Department of Medicine, University of Cape Town, Cape Town, South Africa (J.M.H.); the Department of Neurosciences, Mental Health and Sensory Organs, Sapienza University of Rome (G.A.), the Department of Neurology, Catholic University, (A.E.) - both in Rome; the Department of Neurology, Johannes Gutenberg University, Mainz, Germany (W.N.); the Department of Neurology, University of Rochester Medical Center, Rochester, New York (E.C.); the Division of Neurology, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand (R.W.); the Department of Neurology, Royal Melbourne Hospital, Victoria, Australia (J.O.K.); the Department of Neurology, University of Southern California, Los Angeles (S.R.B.), and the Department of Neurology, University of California Irvine Medical Center, Orange (T.M.) - both in California; the Department of Neurology, Medical College of Wisconsin, Milwaukee (A.C.B.); the Department of Neurology, Harvard Medical School, Boston (A.A.A.); Nerve and Muscle Center of Texas, Houston (A.I.S.), and the Department of Neurology, University of Texas Health Science Center, San Antonio (C.E.J.) - both in Texas; the Department of Neurology, Case Western Reserve University, Cleveland (B.K.), and the Department of Neurology, Ohio State University Wexner Medical Center, Columbus (J.T.K.) - both in Ohio; Walton Centre for Neurology and Neurosurgery, Liverpool (B.R.F.L.), and Nuffield Department of Clinical Neurosciences, Oxford University, Oxford (C.B., A.V.) - both in the United Kingdom; Unit of Neurology, University of Brasilia, Brasilia (E.D.-T.), the Department of Neurology, Federal University, Rio de Janeiro (M.W.-C.), and the Department of Neurology, Universidade Federal do Parana, Curitiba (L.C.W.) - all in Brazil; the Department of Neurology, Kanazawa University, Kanazawa, Japan (H.Y.); the Department of Neurology, University of Florida, Jacksonville (M.T.P.), and the Department of Neurology, University of Miami, Miami (M.B.) - both in Florida; the Department of Neurology, Augusta University, Augusta (M.H.R.); the Department of Neurology, Medical University of Warsaw, Warsaw, Poland (A.K.-P.); the Department of Neurology, Indiana School of Medicine, Indianapolis (R.M.P.); the Department of Neurology, Leiden University Medical Center, Leiden, the Netherlands (J.J.G.M.V.); the Department of Neurology, Duke University Medical Center, Durham, NC (J.M.M.); the Department of Neurology, University of Kansas Medical Center, Kansas City (R.J.B.); the Department of Neurological Sciences, University of Vermont College of Medicine, Burlington (R.T.); the Division of Extramural Research, National Institutes of Health, National Institute of Neurological Disorders and Stroke, Bethesda, MD (R.C.); the Section of General Thoracic Surgery, Columbia University Medical Center, New York (J.R.S.); the Department of Neurology, University at Buffalo Jacobs School of Medicine and Biomedical Sciences, Buffalo (G.I.W.).'}, {'ForeName': 'Bashar', 'Initials': 'B', 'LastName': 'Katirji', 'Affiliation': 'From the Department of Neurology, University of Alabama at Birmingham, Birmingham (I.L.); the Department of Biostatistics, University of Alabama at Birmingham, Birmingham (H.-C.K., I.B.A., G.R.C., T.M., G.M); the Department of Neurology, George Washington University School of Medicine and Health Sciences, Washington, DC (H.J.K.); the Department of Neurology, Greater Manchester Neuroscience Center, Salford, Greater Manchester, UK (J.S.); the Institute of Pathology, University Medical Center Göttingen, Göttingen (P.S.); the Department of Neurology, McGill University, Montreal (C.H.C.), and the Division of Neurology, University of British Columbia, Vancouver (J. Oger) - both in Canada; the Department of Neurology, University of Chile, Santiago (G.C.); the Division of Neurology, Department of Medicine, University of Cape Town, Cape Town, South Africa (J.M.H.); the Department of Neurosciences, Mental Health and Sensory Organs, Sapienza University of Rome (G.A.), the Department of Neurology, Catholic University, (A.E.) - both in Rome; the Department of Neurology, Johannes Gutenberg University, Mainz, Germany (W.N.); the Department of Neurology, University of Rochester Medical Center, Rochester, New York (E.C.); the Division of Neurology, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand (R.W.); the Department of Neurology, Royal Melbourne Hospital, Victoria, Australia (J.O.K.); the Department of Neurology, University of Southern California, Los Angeles (S.R.B.), and the Department of Neurology, University of California Irvine Medical Center, Orange (T.M.) - both in California; the Department of Neurology, Medical College of Wisconsin, Milwaukee (A.C.B.); the Department of Neurology, Harvard Medical School, Boston (A.A.A.); Nerve and Muscle Center of Texas, Houston (A.I.S.), and the Department of Neurology, University of Texas Health Science Center, San Antonio (C.E.J.) - both in Texas; the Department of Neurology, Case Western Reserve University, Cleveland (B.K.), and the Department of Neurology, Ohio State University Wexner Medical Center, Columbus (J.T.K.) - both in Ohio; Walton Centre for Neurology and Neurosurgery, Liverpool (B.R.F.L.), and Nuffield Department of Clinical Neurosciences, Oxford University, Oxford (C.B., A.V.) - both in the United Kingdom; Unit of Neurology, University of Brasilia, Brasilia (E.D.-T.), the Department of Neurology, Federal University, Rio de Janeiro (M.W.-C.), and the Department of Neurology, Universidade Federal do Parana, Curitiba (L.C.W.) - all in Brazil; the Department of Neurology, Kanazawa University, Kanazawa, Japan (H.Y.); the Department of Neurology, University of Florida, Jacksonville (M.T.P.), and the Department of Neurology, University of Miami, Miami (M.B.) - both in Florida; the Department of Neurology, Augusta University, Augusta (M.H.R.); the Department of Neurology, Medical University of Warsaw, Warsaw, Poland (A.K.-P.); the Department of Neurology, Indiana School of Medicine, Indianapolis (R.M.P.); the Department of Neurology, Leiden University Medical Center, Leiden, the Netherlands (J.J.G.M.V.); the Department of Neurology, Duke University Medical Center, Durham, NC (J.M.M.); the Department of Neurology, University of Kansas Medical Center, Kansas City (R.J.B.); the Department of Neurological Sciences, University of Vermont College of Medicine, Burlington (R.T.); the Division of Extramural Research, National Institutes of Health, National Institute of Neurological Disorders and Stroke, Bethesda, MD (R.C.); the Section of General Thoracic Surgery, Columbia University Medical Center, New York (J.R.S.); the Department of Neurology, University at Buffalo Jacobs School of Medicine and Biomedical Sciences, Buffalo (G.I.W.).'}, {'ForeName': 'Bryan R F', 'Initials': 'BRF', 'LastName': 'Lecky', 'Affiliation': 'From the Department of Neurology, University of Alabama at Birmingham, Birmingham (I.L.); the Department of Biostatistics, University of Alabama at Birmingham, Birmingham (H.-C.K., I.B.A., G.R.C., T.M., G.M); the Department of Neurology, George Washington University School of Medicine and Health Sciences, Washington, DC (H.J.K.); the Department of Neurology, Greater Manchester Neuroscience Center, Salford, Greater Manchester, UK (J.S.); the Institute of Pathology, University Medical Center Göttingen, Göttingen (P.S.); the Department of Neurology, McGill University, Montreal (C.H.C.), and the Division of Neurology, University of British Columbia, Vancouver (J. Oger) - both in Canada; the Department of Neurology, University of Chile, Santiago (G.C.); the Division of Neurology, Department of Medicine, University of Cape Town, Cape Town, South Africa (J.M.H.); the Department of Neurosciences, Mental Health and Sensory Organs, Sapienza University of Rome (G.A.), the Department of Neurology, Catholic University, (A.E.) - both in Rome; the Department of Neurology, Johannes Gutenberg University, Mainz, Germany (W.N.); the Department of Neurology, University of Rochester Medical Center, Rochester, New York (E.C.); the Division of Neurology, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand (R.W.); the Department of Neurology, Royal Melbourne Hospital, Victoria, Australia (J.O.K.); the Department of Neurology, University of Southern California, Los Angeles (S.R.B.), and the Department of Neurology, University of California Irvine Medical Center, Orange (T.M.) - both in California; the Department of Neurology, Medical College of Wisconsin, Milwaukee (A.C.B.); the Department of Neurology, Harvard Medical School, Boston (A.A.A.); Nerve and Muscle Center of Texas, Houston (A.I.S.), and the Department of Neurology, University of Texas Health Science Center, San Antonio (C.E.J.) - both in Texas; the Department of Neurology, Case Western Reserve University, Cleveland (B.K.), and the Department of Neurology, Ohio State University Wexner Medical Center, Columbus (J.T.K.) - both in Ohio; Walton Centre for Neurology and Neurosurgery, Liverpool (B.R.F.L.), and Nuffield Department of Clinical Neurosciences, Oxford University, Oxford (C.B., A.V.) - both in the United Kingdom; Unit of Neurology, University of Brasilia, Brasilia (E.D.-T.), the Department of Neurology, Federal University, Rio de Janeiro (M.W.-C.), and the Department of Neurology, Universidade Federal do Parana, Curitiba (L.C.W.) - all in Brazil; the Department of Neurology, Kanazawa University, Kanazawa, Japan (H.Y.); the Department of Neurology, University of Florida, Jacksonville (M.T.P.), and the Department of Neurology, University of Miami, Miami (M.B.) - both in Florida; the Department of Neurology, Augusta University, Augusta (M.H.R.); the Department of Neurology, Medical University of Warsaw, Warsaw, Poland (A.K.-P.); the Department of Neurology, Indiana School of Medicine, Indianapolis (R.M.P.); the Department of Neurology, Leiden University Medical Center, Leiden, the Netherlands (J.J.G.M.V.); the Department of Neurology, Duke University Medical Center, Durham, NC (J.M.M.); the Department of Neurology, University of Kansas Medical Center, Kansas City (R.J.B.); the Department of Neurological Sciences, University of Vermont College of Medicine, Burlington (R.T.); the Division of Extramural Research, National Institutes of Health, National Institute of Neurological Disorders and Stroke, Bethesda, MD (R.C.); the Section of General Thoracic Surgery, Columbia University Medical Center, New York (J.R.S.); the Department of Neurology, University at Buffalo Jacobs School of Medicine and Biomedical Sciences, Buffalo (G.I.W.).'}, {'ForeName': 'Camilla', 'Initials': 'C', 'LastName': 'Buckley', 'Affiliation': 'From the Department of Neurology, University of Alabama at Birmingham, Birmingham (I.L.); the Department of Biostatistics, University of Alabama at Birmingham, Birmingham (H.-C.K., I.B.A., G.R.C., T.M., G.M); the Department of Neurology, George Washington University School of Medicine and Health Sciences, Washington, DC (H.J.K.); the Department of Neurology, Greater Manchester Neuroscience Center, Salford, Greater Manchester, UK (J.S.); the Institute of Pathology, University Medical Center Göttingen, Göttingen (P.S.); the Department of Neurology, McGill University, Montreal (C.H.C.), and the Division of Neurology, University of British Columbia, Vancouver (J. Oger) - both in Canada; the Department of Neurology, University of Chile, Santiago (G.C.); the Division of Neurology, Department of Medicine, University of Cape Town, Cape Town, South Africa (J.M.H.); the Department of Neurosciences, Mental Health and Sensory Organs, Sapienza University of Rome (G.A.), the Department of Neurology, Catholic University, (A.E.) - both in Rome; the Department of Neurology, Johannes Gutenberg University, Mainz, Germany (W.N.); the Department of Neurology, University of Rochester Medical Center, Rochester, New York (E.C.); the Division of Neurology, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand (R.W.); the Department of Neurology, Royal Melbourne Hospital, Victoria, Australia (J.O.K.); the Department of Neurology, University of Southern California, Los Angeles (S.R.B.), and the Department of Neurology, University of California Irvine Medical Center, Orange (T.M.) - both in California; the Department of Neurology, Medical College of Wisconsin, Milwaukee (A.C.B.); the Department of Neurology, Harvard Medical School, Boston (A.A.A.); Nerve and Muscle Center of Texas, Houston (A.I.S.), and the Department of Neurology, University of Texas Health Science Center, San Antonio (C.E.J.) - both in Texas; the Department of Neurology, Case Western Reserve University, Cleveland (B.K.), and the Department of Neurology, Ohio State University Wexner Medical Center, Columbus (J.T.K.) - both in Ohio; Walton Centre for Neurology and Neurosurgery, Liverpool (B.R.F.L.), and Nuffield Department of Clinical Neurosciences, Oxford University, Oxford (C.B., A.V.) - both in the United Kingdom; Unit of Neurology, University of Brasilia, Brasilia (E.D.-T.), the Department of Neurology, Federal University, Rio de Janeiro (M.W.-C.), and the Department of Neurology, Universidade Federal do Parana, Curitiba (L.C.W.) - all in Brazil; the Department of Neurology, Kanazawa University, Kanazawa, Japan (H.Y.); the Department of Neurology, University of Florida, Jacksonville (M.T.P.), and the Department of Neurology, University of Miami, Miami (M.B.) - both in Florida; the Department of Neurology, Augusta University, Augusta (M.H.R.); the Department of Neurology, Medical University of Warsaw, Warsaw, Poland (A.K.-P.); the Department of Neurology, Indiana School of Medicine, Indianapolis (R.M.P.); the Department of Neurology, Leiden University Medical Center, Leiden, the Netherlands (J.J.G.M.V.); the Department of Neurology, Duke University Medical Center, Durham, NC (J.M.M.); the Department of Neurology, University of Kansas Medical Center, Kansas City (R.J.B.); the Department of Neurological Sciences, University of Vermont College of Medicine, Burlington (R.T.); the Division of Extramural Research, National Institutes of Health, National Institute of Neurological Disorders and Stroke, Bethesda, MD (R.C.); the Section of General Thoracic Surgery, Columbia University Medical Center, New York (J.R.S.); the Department of Neurology, University at Buffalo Jacobs School of Medicine and Biomedical Sciences, Buffalo (G.I.W.).'}, {'ForeName': 'Angela', 'Initials': 'A', 'LastName': 'Vincent', 'Affiliation': 'From the Department of Neurology, University of Alabama at Birmingham, Birmingham (I.L.); the Department of Biostatistics, University of Alabama at Birmingham, Birmingham (H.-C.K., I.B.A., G.R.C., T.M., G.M); the Department of Neurology, George Washington University School of Medicine and Health Sciences, Washington, DC (H.J.K.); the Department of Neurology, Greater Manchester Neuroscience Center, Salford, Greater Manchester, UK (J.S.); the Institute of Pathology, University Medical Center Göttingen, Göttingen (P.S.); the Department of Neurology, McGill University, Montreal (C.H.C.), and the Division of Neurology, University of British Columbia, Vancouver (J. Oger) - both in Canada; the Department of Neurology, University of Chile, Santiago (G.C.); the Division of Neurology, Department of Medicine, University of Cape Town, Cape Town, South Africa (J.M.H.); the Department of Neurosciences, Mental Health and Sensory Organs, Sapienza University of Rome (G.A.), the Department of Neurology, Catholic University, (A.E.) - both in Rome; the Department of Neurology, Johannes Gutenberg University, Mainz, Germany (W.N.); the Department of Neurology, University of Rochester Medical Center, Rochester, New York (E.C.); the Division of Neurology, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand (R.W.); the Department of Neurology, Royal Melbourne Hospital, Victoria, Australia (J.O.K.); the Department of Neurology, University of Southern California, Los Angeles (S.R.B.), and the Department of Neurology, University of California Irvine Medical Center, Orange (T.M.) - both in California; the Department of Neurology, Medical College of Wisconsin, Milwaukee (A.C.B.); the Department of Neurology, Harvard Medical School, Boston (A.A.A.); Nerve and Muscle Center of Texas, Houston (A.I.S.), and the Department of Neurology, University of Texas Health Science Center, San Antonio (C.E.J.) - both in Texas; the Department of Neurology, Case Western Reserve University, Cleveland (B.K.), and the Department of Neurology, Ohio State University Wexner Medical Center, Columbus (J.T.K.) - both in Ohio; Walton Centre for Neurology and Neurosurgery, Liverpool (B.R.F.L.), and Nuffield Department of Clinical Neurosciences, Oxford University, Oxford (C.B., A.V.) - both in the United Kingdom; Unit of Neurology, University of Brasilia, Brasilia (E.D.-T.), the Department of Neurology, Federal University, Rio de Janeiro (M.W.-C.), and the Department of Neurology, Universidade Federal do Parana, Curitiba (L.C.W.) - all in Brazil; the Department of Neurology, Kanazawa University, Kanazawa, Japan (H.Y.); the Department of Neurology, University of Florida, Jacksonville (M.T.P.), and the Department of Neurology, University of Miami, Miami (M.B.) - both in Florida; the Department of Neurology, Augusta University, Augusta (M.H.R.); the Department of Neurology, Medical University of Warsaw, Warsaw, Poland (A.K.-P.); the Department of Neurology, Indiana School of Medicine, Indianapolis (R.M.P.); the Department of Neurology, Leiden University Medical Center, Leiden, the Netherlands (J.J.G.M.V.); the Department of Neurology, Duke University Medical Center, Durham, NC (J.M.M.); the Department of Neurology, University of Kansas Medical Center, Kansas City (R.J.B.); the Department of Neurological Sciences, University of Vermont College of Medicine, Burlington (R.T.); the Division of Extramural Research, National Institutes of Health, National Institute of Neurological Disorders and Stroke, Bethesda, MD (R.C.); the Section of General Thoracic Surgery, Columbia University Medical Center, New York (J.R.S.); the Department of Neurology, University at Buffalo Jacobs School of Medicine and Biomedical Sciences, Buffalo (G.I.W.).'}, {'ForeName': 'Elza', 'Initials': 'E', 'LastName': 'Dias-Tosta', 'Affiliation': 'From the Department of Neurology, University of Alabama at Birmingham, Birmingham (I.L.); the Department of Biostatistics, University of Alabama at Birmingham, Birmingham (H.-C.K., I.B.A., G.R.C., T.M., G.M); the Department of Neurology, George Washington University School of Medicine and Health Sciences, Washington, DC (H.J.K.); the Department of Neurology, Greater Manchester Neuroscience Center, Salford, Greater Manchester, UK (J.S.); the Institute of Pathology, University Medical Center Göttingen, Göttingen (P.S.); the Department of Neurology, McGill University, Montreal (C.H.C.), and the Division of Neurology, University of British Columbia, Vancouver (J. Oger) - both in Canada; the Department of Neurology, University of Chile, Santiago (G.C.); the Division of Neurology, Department of Medicine, University of Cape Town, Cape Town, South Africa (J.M.H.); the Department of Neurosciences, Mental Health and Sensory Organs, Sapienza University of Rome (G.A.), the Department of Neurology, Catholic University, (A.E.) - both in Rome; the Department of Neurology, Johannes Gutenberg University, Mainz, Germany (W.N.); the Department of Neurology, University of Rochester Medical Center, Rochester, New York (E.C.); the Division of Neurology, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand (R.W.); the Department of Neurology, Royal Melbourne Hospital, Victoria, Australia (J.O.K.); the Department of Neurology, University of Southern California, Los Angeles (S.R.B.), and the Department of Neurology, University of California Irvine Medical Center, Orange (T.M.) - both in California; the Department of Neurology, Medical College of Wisconsin, Milwaukee (A.C.B.); the Department of Neurology, Harvard Medical School, Boston (A.A.A.); Nerve and Muscle Center of Texas, Houston (A.I.S.), and the Department of Neurology, University of Texas Health Science Center, San Antonio (C.E.J.) - both in Texas; the Department of Neurology, Case Western Reserve University, Cleveland (B.K.), and the Department of Neurology, Ohio State University Wexner Medical Center, Columbus (J.T.K.) - both in Ohio; Walton Centre for Neurology and Neurosurgery, Liverpool (B.R.F.L.), and Nuffield Department of Clinical Neurosciences, Oxford University, Oxford (C.B., A.V.) - both in the United Kingdom; Unit of Neurology, University of Brasilia, Brasilia (E.D.-T.), the Department of Neurology, Federal University, Rio de Janeiro (M.W.-C.), and the Department of Neurology, Universidade Federal do Parana, Curitiba (L.C.W.) - all in Brazil; the Department of Neurology, Kanazawa University, Kanazawa, Japan (H.Y.); the Department of Neurology, University of Florida, Jacksonville (M.T.P.), and the Department of Neurology, University of Miami, Miami (M.B.) - both in Florida; the Department of Neurology, Augusta University, Augusta (M.H.R.); the Department of Neurology, Medical University of Warsaw, Warsaw, Poland (A.K.-P.); the Department of Neurology, Indiana School of Medicine, Indianapolis (R.M.P.); the Department of Neurology, Leiden University Medical Center, Leiden, the Netherlands (J.J.G.M.V.); the Department of Neurology, Duke University Medical Center, Durham, NC (J.M.M.); the Department of Neurology, University of Kansas Medical Center, Kansas City (R.J.B.); the Department of Neurological Sciences, University of Vermont College of Medicine, Burlington (R.T.); the Division of Extramural Research, National Institutes of Health, National Institute of Neurological Disorders and Stroke, Bethesda, MD (R.C.); the Section of General Thoracic Surgery, Columbia University Medical Center, New York (J.R.S.); the Department of Neurology, University at Buffalo Jacobs School of Medicine and Biomedical Sciences, Buffalo (G.I.W.).'}, {'ForeName': 'Hiroaki', 'Initials': 'H', 'LastName': 'Yoshikawa', 'Affiliation': 'From the Department of Neurology, University of Alabama at Birmingham, Birmingham (I.L.); the Department of Biostatistics, University of Alabama at Birmingham, Birmingham (H.-C.K., I.B.A., G.R.C., T.M., G.M); the Department of Neurology, George Washington University School of Medicine and Health Sciences, Washington, DC (H.J.K.); the Department of Neurology, Greater Manchester Neuroscience Center, Salford, Greater Manchester, UK (J.S.); the Institute of Pathology, University Medical Center Göttingen, Göttingen (P.S.); the Department of Neurology, McGill University, Montreal (C.H.C.), and the Division of Neurology, University of British Columbia, Vancouver (J. Oger) - both in Canada; the Department of Neurology, University of Chile, Santiago (G.C.); the Division of Neurology, Department of Medicine, University of Cape Town, Cape Town, South Africa (J.M.H.); the Department of Neurosciences, Mental Health and Sensory Organs, Sapienza University of Rome (G.A.), the Department of Neurology, Catholic University, (A.E.) - both in Rome; the Department of Neurology, Johannes Gutenberg University, Mainz, Germany (W.N.); the Department of Neurology, University of Rochester Medical Center, Rochester, New York (E.C.); the Division of Neurology, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand (R.W.); the Department of Neurology, Royal Melbourne Hospital, Victoria, Australia (J.O.K.); the Department of Neurology, University of Southern California, Los Angeles (S.R.B.), and the Department of Neurology, University of California Irvine Medical Center, Orange (T.M.) - both in California; the Department of Neurology, Medical College of Wisconsin, Milwaukee (A.C.B.); the Department of Neurology, Harvard Medical School, Boston (A.A.A.); Nerve and Muscle Center of Texas, Houston (A.I.S.), and the Department of Neurology, University of Texas Health Science Center, San Antonio (C.E.J.) - both in Texas; the Department of Neurology, Case Western Reserve University, Cleveland (B.K.), and the Department of Neurology, Ohio State University Wexner Medical Center, Columbus (J.T.K.) - both in Ohio; Walton Centre for Neurology and Neurosurgery, Liverpool (B.R.F.L.), and Nuffield Department of Clinical Neurosciences, Oxford University, Oxford (C.B., A.V.) - both in the United Kingdom; Unit of Neurology, University of Brasilia, Brasilia (E.D.-T.), the Department of Neurology, Federal University, Rio de Janeiro (M.W.-C.), and the Department of Neurology, Universidade Federal do Parana, Curitiba (L.C.W.) - all in Brazil; the Department of Neurology, Kanazawa University, Kanazawa, Japan (H.Y.); the Department of Neurology, University of Florida, Jacksonville (M.T.P.), and the Department of Neurology, University of Miami, Miami (M.B.) - both in Florida; the Department of Neurology, Augusta University, Augusta (M.H.R.); the Department of Neurology, Medical University of Warsaw, Warsaw, Poland (A.K.-P.); the Department of Neurology, Indiana School of Medicine, Indianapolis (R.M.P.); the Department of Neurology, Leiden University Medical Center, Leiden, the Netherlands (J.J.G.M.V.); the Department of Neurology, Duke University Medical Center, Durham, NC (J.M.M.); the Department of Neurology, University of Kansas Medical Center, Kansas City (R.J.B.); the Department of Neurological Sciences, University of Vermont College of Medicine, Burlington (R.T.); the Division of Extramural Research, National Institutes of Health, National Institute of Neurological Disorders and Stroke, Bethesda, MD (R.C.); the Section of General Thoracic Surgery, Columbia University Medical Center, New York (J.R.S.); the Department of Neurology, University at Buffalo Jacobs School of Medicine and Biomedical Sciences, Buffalo (G.I.W.).'}, {'ForeName': 'Marcia', 'Initials': 'M', 'LastName': 'Waddington-Cruz', 'Affiliation': 'From the Department of Neurology, University of Alabama at Birmingham, Birmingham (I.L.); the Department of Biostatistics, University of Alabama at Birmingham, Birmingham (H.-C.K., I.B.A., G.R.C., T.M., G.M); the Department of Neurology, George Washington University School of Medicine and Health Sciences, Washington, DC (H.J.K.); the Department of Neurology, Greater Manchester Neuroscience Center, Salford, Greater Manchester, UK (J.S.); the Institute of Pathology, University Medical Center Göttingen, Göttingen (P.S.); the Department of Neurology, McGill University, Montreal (C.H.C.), and the Division of Neurology, University of British Columbia, Vancouver (J. Oger) - both in Canada; the Department of Neurology, University of Chile, Santiago (G.C.); the Division of Neurology, Department of Medicine, University of Cape Town, Cape Town, South Africa (J.M.H.); the Department of Neurosciences, Mental Health and Sensory Organs, Sapienza University of Rome (G.A.), the Department of Neurology, Catholic University, (A.E.) - both in Rome; the Department of Neurology, Johannes Gutenberg University, Mainz, Germany (W.N.); the Department of Neurology, University of Rochester Medical Center, Rochester, New York (E.C.); the Division of Neurology, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand (R.W.); the Department of Neurology, Royal Melbourne Hospital, Victoria, Australia (J.O.K.); the Department of Neurology, University of Southern California, Los Angeles (S.R.B.), and the Department of Neurology, University of California Irvine Medical Center, Orange (T.M.) - both in California; the Department of Neurology, Medical College of Wisconsin, Milwaukee (A.C.B.); the Department of Neurology, Harvard Medical School, Boston (A.A.A.); Nerve and Muscle Center of Texas, Houston (A.I.S.), and the Department of Neurology, University of Texas Health Science Center, San Antonio (C.E.J.) - both in Texas; the Department of Neurology, Case Western Reserve University, Cleveland (B.K.), and the Department of Neurology, Ohio State University Wexner Medical Center, Columbus (J.T.K.) - both in Ohio; Walton Centre for Neurology and Neurosurgery, Liverpool (B.R.F.L.), and Nuffield Department of Clinical Neurosciences, Oxford University, Oxford (C.B., A.V.) - both in the United Kingdom; Unit of Neurology, University of Brasilia, Brasilia (E.D.-T.), the Department of Neurology, Federal University, Rio de Janeiro (M.W.-C.), and the Department of Neurology, Universidade Federal do Parana, Curitiba (L.C.W.) - all in Brazil; the Department of Neurology, Kanazawa University, Kanazawa, Japan (H.Y.); the Department of Neurology, University of Florida, Jacksonville (M.T.P.), and the Department of Neurology, University of Miami, Miami (M.B.) - both in Florida; the Department of Neurology, Augusta University, Augusta (M.H.R.); the Department of Neurology, Medical University of Warsaw, Warsaw, Poland (A.K.-P.); the Department of Neurology, Indiana School of Medicine, Indianapolis (R.M.P.); the Department of Neurology, Leiden University Medical Center, Leiden, the Netherlands (J.J.G.M.V.); the Department of Neurology, Duke University Medical Center, Durham, NC (J.M.M.); the Department of Neurology, University of Kansas Medical Center, Kansas City (R.J.B.); the Department of Neurological Sciences, University of Vermont College of Medicine, Burlington (R.T.); the Division of Extramural Research, National Institutes of Health, National Institute of Neurological Disorders and Stroke, Bethesda, MD (R.C.); the Section of General Thoracic Surgery, Columbia University Medical Center, New York (J.R.S.); the Department of Neurology, University at Buffalo Jacobs School of Medicine and Biomedical Sciences, Buffalo (G.I.W.).'}, {'ForeName': 'Michael T', 'Initials': 'MT', 'LastName': 'Pulley', 'Affiliation': 'From the Department of Neurology, University of Alabama at Birmingham, Birmingham (I.L.); the Department of Biostatistics, University of Alabama at Birmingham, Birmingham (H.-C.K., I.B.A., G.R.C., T.M., G.M); the Department of Neurology, George Washington University School of Medicine and Health Sciences, Washington, DC (H.J.K.); the Department of Neurology, Greater Manchester Neuroscience Center, Salford, Greater Manchester, UK (J.S.); the Institute of Pathology, University Medical Center Göttingen, Göttingen (P.S.); the Department of Neurology, McGill University, Montreal (C.H.C.), and the Division of Neurology, University of British Columbia, Vancouver (J. Oger) - both in Canada; the Department of Neurology, University of Chile, Santiago (G.C.); the Division of Neurology, Department of Medicine, University of Cape Town, Cape Town, South Africa (J.M.H.); the Department of Neurosciences, Mental Health and Sensory Organs, Sapienza University of Rome (G.A.), the Department of Neurology, Catholic University, (A.E.) - both in Rome; the Department of Neurology, Johannes Gutenberg University, Mainz, Germany (W.N.); the Department of Neurology, University of Rochester Medical Center, Rochester, New York (E.C.); the Division of Neurology, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand (R.W.); the Department of Neurology, Royal Melbourne Hospital, Victoria, Australia (J.O.K.); the Department of Neurology, University of Southern California, Los Angeles (S.R.B.), and the Department of Neurology, University of California Irvine Medical Center, Orange (T.M.) - both in California; the Department of Neurology, Medical College of Wisconsin, Milwaukee (A.C.B.); the Department of Neurology, Harvard Medical School, Boston (A.A.A.); Nerve and Muscle Center of Texas, Houston (A.I.S.), and the Department of Neurology, University of Texas Health Science Center, San Antonio (C.E.J.) - both in Texas; the Department of Neurology, Case Western Reserve University, Cleveland (B.K.), and the Department of Neurology, Ohio State University Wexner Medical Center, Columbus (J.T.K.) - both in Ohio; Walton Centre for Neurology and Neurosurgery, Liverpool (B.R.F.L.), and Nuffield Department of Clinical Neurosciences, Oxford University, Oxford (C.B., A.V.) - both in the United Kingdom; Unit of Neurology, University of Brasilia, Brasilia (E.D.-T.), the Department of Neurology, Federal University, Rio de Janeiro (M.W.-C.), and the Department of Neurology, Universidade Federal do Parana, Curitiba (L.C.W.) - all in Brazil; the Department of Neurology, Kanazawa University, Kanazawa, Japan (H.Y.); the Department of Neurology, University of Florida, Jacksonville (M.T.P.), and the Department of Neurology, University of Miami, Miami (M.B.) - both in Florida; the Department of Neurology, Augusta University, Augusta (M.H.R.); the Department of Neurology, Medical University of Warsaw, Warsaw, Poland (A.K.-P.); the Department of Neurology, Indiana School of Medicine, Indianapolis (R.M.P.); the Department of Neurology, Leiden University Medical Center, Leiden, the Netherlands (J.J.G.M.V.); the Department of Neurology, Duke University Medical Center, Durham, NC (J.M.M.); the Department of Neurology, University of Kansas Medical Center, Kansas City (R.J.B.); the Department of Neurological Sciences, University of Vermont College of Medicine, Burlington (R.T.); the Division of Extramural Research, National Institutes of Health, National Institute of Neurological Disorders and Stroke, Bethesda, MD (R.C.); the Section of General Thoracic Surgery, Columbia University Medical Center, New York (J.R.S.); the Department of Neurology, University at Buffalo Jacobs School of Medicine and Biomedical Sciences, Buffalo (G.I.W.).'}, {'ForeName': 'Michael H', 'Initials': 'MH', 'LastName': 'Rivner', 'Affiliation': 'From the Department of Neurology, University of Alabama at Birmingham, Birmingham (I.L.); the Department of Biostatistics, University of Alabama at Birmingham, Birmingham (H.-C.K., I.B.A., G.R.C., T.M., G.M); the Department of Neurology, George Washington University School of Medicine and Health Sciences, Washington, DC (H.J.K.); the Department of Neurology, Greater Manchester Neuroscience Center, Salford, Greater Manchester, UK (J.S.); the Institute of Pathology, University Medical Center Göttingen, Göttingen (P.S.); the Department of Neurology, McGill University, Montreal (C.H.C.), and the Division of Neurology, University of British Columbia, Vancouver (J. Oger) - both in Canada; the Department of Neurology, University of Chile, Santiago (G.C.); the Division of Neurology, Department of Medicine, University of Cape Town, Cape Town, South Africa (J.M.H.); the Department of Neurosciences, Mental Health and Sensory Organs, Sapienza University of Rome (G.A.), the Department of Neurology, Catholic University, (A.E.) - both in Rome; the Department of Neurology, Johannes Gutenberg University, Mainz, Germany (W.N.); the Department of Neurology, University of Rochester Medical Center, Rochester, New York (E.C.); the Division of Neurology, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand (R.W.); the Department of Neurology, Royal Melbourne Hospital, Victoria, Australia (J.O.K.); the Department of Neurology, University of Southern California, Los Angeles (S.R.B.), and the Department of Neurology, University of California Irvine Medical Center, Orange (T.M.) - both in California; the Department of Neurology, Medical College of Wisconsin, Milwaukee (A.C.B.); the Department of Neurology, Harvard Medical School, Boston (A.A.A.); Nerve and Muscle Center of Texas, Houston (A.I.S.), and the Department of Neurology, University of Texas Health Science Center, San Antonio (C.E.J.) - both in Texas; the Department of Neurology, Case Western Reserve University, Cleveland (B.K.), and the Department of Neurology, Ohio State University Wexner Medical Center, Columbus (J.T.K.) - both in Ohio; Walton Centre for Neurology and Neurosurgery, Liverpool (B.R.F.L.), and Nuffield Department of Clinical Neurosciences, Oxford University, Oxford (C.B., A.V.) - both in the United Kingdom; Unit of Neurology, University of Brasilia, Brasilia (E.D.-T.), the Department of Neurology, Federal University, Rio de Janeiro (M.W.-C.), and the Department of Neurology, Universidade Federal do Parana, Curitiba (L.C.W.) - all in Brazil; the Department of Neurology, Kanazawa University, Kanazawa, Japan (H.Y.); the Department of Neurology, University of Florida, Jacksonville (M.T.P.), and the Department of Neurology, University of Miami, Miami (M.B.) - both in Florida; the Department of Neurology, Augusta University, Augusta (M.H.R.); the Department of Neurology, Medical University of Warsaw, Warsaw, Poland (A.K.-P.); the Department of Neurology, Indiana School of Medicine, Indianapolis (R.M.P.); the Department of Neurology, Leiden University Medical Center, Leiden, the Netherlands (J.J.G.M.V.); the Department of Neurology, Duke University Medical Center, Durham, NC (J.M.M.); the Department of Neurology, University of Kansas Medical Center, Kansas City (R.J.B.); the Department of Neurological Sciences, University of Vermont College of Medicine, Burlington (R.T.); the Division of Extramural Research, National Institutes of Health, National Institute of Neurological Disorders and Stroke, Bethesda, MD (R.C.); the Section of General Thoracic Surgery, Columbia University Medical Center, New York (J.R.S.); the Department of Neurology, University at Buffalo Jacobs School of Medicine and Biomedical Sciences, Buffalo (G.I.W.).'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Kostera-Pruszczyk', 'Affiliation': 'From the Department of Neurology, University of Alabama at Birmingham, Birmingham (I.L.); the Department of Biostatistics, University of Alabama at Birmingham, Birmingham (H.-C.K., I.B.A., G.R.C., T.M., G.M); the Department of Neurology, George Washington University School of Medicine and Health Sciences, Washington, DC (H.J.K.); the Department of Neurology, Greater Manchester Neuroscience Center, Salford, Greater Manchester, UK (J.S.); the Institute of Pathology, University Medical Center Göttingen, Göttingen (P.S.); the Department of Neurology, McGill University, Montreal (C.H.C.), and the Division of Neurology, University of British Columbia, Vancouver (J. Oger) - both in Canada; the Department of Neurology, University of Chile, Santiago (G.C.); the Division of Neurology, Department of Medicine, University of Cape Town, Cape Town, South Africa (J.M.H.); the Department of Neurosciences, Mental Health and Sensory Organs, Sapienza University of Rome (G.A.), the Department of Neurology, Catholic University, (A.E.) - both in Rome; the Department of Neurology, Johannes Gutenberg University, Mainz, Germany (W.N.); the Department of Neurology, University of Rochester Medical Center, Rochester, New York (E.C.); the Division of Neurology, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand (R.W.); the Department of Neurology, Royal Melbourne Hospital, Victoria, Australia (J.O.K.); the Department of Neurology, University of Southern California, Los Angeles (S.R.B.), and the Department of Neurology, University of California Irvine Medical Center, Orange (T.M.) - both in California; the Department of Neurology, Medical College of Wisconsin, Milwaukee (A.C.B.); the Department of Neurology, Harvard Medical School, Boston (A.A.A.); Nerve and Muscle Center of Texas, Houston (A.I.S.), and the Department of Neurology, University of Texas Health Science Center, San Antonio (C.E.J.) - both in Texas; the Department of Neurology, Case Western Reserve University, Cleveland (B.K.), and the Department of Neurology, Ohio State University Wexner Medical Center, Columbus (J.T.K.) - both in Ohio; Walton Centre for Neurology and Neurosurgery, Liverpool (B.R.F.L.), and Nuffield Department of Clinical Neurosciences, Oxford University, Oxford (C.B., A.V.) - both in the United Kingdom; Unit of Neurology, University of Brasilia, Brasilia (E.D.-T.), the Department of Neurology, Federal University, Rio de Janeiro (M.W.-C.), and the Department of Neurology, Universidade Federal do Parana, Curitiba (L.C.W.) - all in Brazil; the Department of Neurology, Kanazawa University, Kanazawa, Japan (H.Y.); the Department of Neurology, University of Florida, Jacksonville (M.T.P.), and the Department of Neurology, University of Miami, Miami (M.B.) - both in Florida; the Department of Neurology, Augusta University, Augusta (M.H.R.); the Department of Neurology, Medical University of Warsaw, Warsaw, Poland (A.K.-P.); the Department of Neurology, Indiana School of Medicine, Indianapolis (R.M.P.); the Department of Neurology, Leiden University Medical Center, Leiden, the Netherlands (J.J.G.M.V.); the Department of Neurology, Duke University Medical Center, Durham, NC (J.M.M.); the Department of Neurology, University of Kansas Medical Center, Kansas City (R.J.B.); the Department of Neurological Sciences, University of Vermont College of Medicine, Burlington (R.T.); the Division of Extramural Research, National Institutes of Health, National Institute of Neurological Disorders and Stroke, Bethesda, MD (R.C.); the Section of General Thoracic Surgery, Columbia University Medical Center, New York (J.R.S.); the Department of Neurology, University at Buffalo Jacobs School of Medicine and Biomedical Sciences, Buffalo (G.I.W.).'}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Pascuzzi', 'Affiliation': 'From the Department of Neurology, University of Alabama at Birmingham, Birmingham (I.L.); the Department of Biostatistics, University of Alabama at Birmingham, Birmingham (H.-C.K., I.B.A., G.R.C., T.M., G.M); the Department of Neurology, George Washington University School of Medicine and Health Sciences, Washington, DC (H.J.K.); the Department of Neurology, Greater Manchester Neuroscience Center, Salford, Greater Manchester, UK (J.S.); the Institute of Pathology, University Medical Center Göttingen, Göttingen (P.S.); the Department of Neurology, McGill University, Montreal (C.H.C.), and the Division of Neurology, University of British Columbia, Vancouver (J. Oger) - both in Canada; the Department of Neurology, University of Chile, Santiago (G.C.); the Division of Neurology, Department of Medicine, University of Cape Town, Cape Town, South Africa (J.M.H.); the Department of Neurosciences, Mental Health and Sensory Organs, Sapienza University of Rome (G.A.), the Department of Neurology, Catholic University, (A.E.) - both in Rome; the Department of Neurology, Johannes Gutenberg University, Mainz, Germany (W.N.); the Department of Neurology, University of Rochester Medical Center, Rochester, New York (E.C.); the Division of Neurology, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand (R.W.); the Department of Neurology, Royal Melbourne Hospital, Victoria, Australia (J.O.K.); the Department of Neurology, University of Southern California, Los Angeles (S.R.B.), and the Department of Neurology, University of California Irvine Medical Center, Orange (T.M.) - both in California; the Department of Neurology, Medical College of Wisconsin, Milwaukee (A.C.B.); the Department of Neurology, Harvard Medical School, Boston (A.A.A.); Nerve and Muscle Center of Texas, Houston (A.I.S.), and the Department of Neurology, University of Texas Health Science Center, San Antonio (C.E.J.) - both in Texas; the Department of Neurology, Case Western Reserve University, Cleveland (B.K.), and the Department of Neurology, Ohio State University Wexner Medical Center, Columbus (J.T.K.) - both in Ohio; Walton Centre for Neurology and Neurosurgery, Liverpool (B.R.F.L.), and Nuffield Department of Clinical Neurosciences, Oxford University, Oxford (C.B., A.V.) - both in the United Kingdom; Unit of Neurology, University of Brasilia, Brasilia (E.D.-T.), the Department of Neurology, Federal University, Rio de Janeiro (M.W.-C.), and the Department of Neurology, Universidade Federal do Parana, Curitiba (L.C.W.) - all in Brazil; the Department of Neurology, Kanazawa University, Kanazawa, Japan (H.Y.); the Department of Neurology, University of Florida, Jacksonville (M.T.P.), and the Department of Neurology, University of Miami, Miami (M.B.) - both in Florida; the Department of Neurology, Augusta University, Augusta (M.H.R.); the Department of Neurology, Medical University of Warsaw, Warsaw, Poland (A.K.-P.); the Department of Neurology, Indiana School of Medicine, Indianapolis (R.M.P.); the Department of Neurology, Leiden University Medical Center, Leiden, the Netherlands (J.J.G.M.V.); the Department of Neurology, Duke University Medical Center, Durham, NC (J.M.M.); the Department of Neurology, University of Kansas Medical Center, Kansas City (R.J.B.); the Department of Neurological Sciences, University of Vermont College of Medicine, Burlington (R.T.); the Division of Extramural Research, National Institutes of Health, National Institute of Neurological Disorders and Stroke, Bethesda, MD (R.C.); the Section of General Thoracic Surgery, Columbia University Medical Center, New York (J.R.S.); the Department of Neurology, University at Buffalo Jacobs School of Medicine and Biomedical Sciences, Buffalo (G.I.W.).'}, {'ForeName': 'Carlayne E', 'Initials': 'CE', 'LastName': 'Jackson', 'Affiliation': 'From the Department of Neurology, University of Alabama at Birmingham, Birmingham (I.L.); the Department of Biostatistics, University of Alabama at Birmingham, Birmingham (H.-C.K., I.B.A., G.R.C., T.M., G.M); the Department of Neurology, George Washington University School of Medicine and Health Sciences, Washington, DC (H.J.K.); the Department of Neurology, Greater Manchester Neuroscience Center, Salford, Greater Manchester, UK (J.S.); the Institute of Pathology, University Medical Center Göttingen, Göttingen (P.S.); the Department of Neurology, McGill University, Montreal (C.H.C.), and the Division of Neurology, University of British Columbia, Vancouver (J. Oger) - both in Canada; the Department of Neurology, University of Chile, Santiago (G.C.); the Division of Neurology, Department of Medicine, University of Cape Town, Cape Town, South Africa (J.M.H.); the Department of Neurosciences, Mental Health and Sensory Organs, Sapienza University of Rome (G.A.), the Department of Neurology, Catholic University, (A.E.) - both in Rome; the Department of Neurology, Johannes Gutenberg University, Mainz, Germany (W.N.); the Department of Neurology, University of Rochester Medical Center, Rochester, New York (E.C.); the Division of Neurology, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand (R.W.); the Department of Neurology, Royal Melbourne Hospital, Victoria, Australia (J.O.K.); the Department of Neurology, University of Southern California, Los Angeles (S.R.B.), and the Department of Neurology, University of California Irvine Medical Center, Orange (T.M.) - both in California; the Department of Neurology, Medical College of Wisconsin, Milwaukee (A.C.B.); the Department of Neurology, Harvard Medical School, Boston (A.A.A.); Nerve and Muscle Center of Texas, Houston (A.I.S.), and the Department of Neurology, University of Texas Health Science Center, San Antonio (C.E.J.) - both in Texas; the Department of Neurology, Case Western Reserve University, Cleveland (B.K.), and the Department of Neurology, Ohio State University Wexner Medical Center, Columbus (J.T.K.) - both in Ohio; Walton Centre for Neurology and Neurosurgery, Liverpool (B.R.F.L.), and Nuffield Department of Clinical Neurosciences, Oxford University, Oxford (C.B., A.V.) - both in the United Kingdom; Unit of Neurology, University of Brasilia, Brasilia (E.D.-T.), the Department of Neurology, Federal University, Rio de Janeiro (M.W.-C.), and the Department of Neurology, Universidade Federal do Parana, Curitiba (L.C.W.) - all in Brazil; the Department of Neurology, Kanazawa University, Kanazawa, Japan (H.Y.); the Department of Neurology, University of Florida, Jacksonville (M.T.P.), and the Department of Neurology, University of Miami, Miami (M.B.) - both in Florida; the Department of Neurology, Augusta University, Augusta (M.H.R.); the Department of Neurology, Medical University of Warsaw, Warsaw, Poland (A.K.-P.); the Department of Neurology, Indiana School of Medicine, Indianapolis (R.M.P.); the Department of Neurology, Leiden University Medical Center, Leiden, the Netherlands (J.J.G.M.V.); the Department of Neurology, Duke University Medical Center, Durham, NC (J.M.M.); the Department of Neurology, University of Kansas Medical Center, Kansas City (R.J.B.); the Department of Neurological Sciences, University of Vermont College of Medicine, Burlington (R.T.); the Division of Extramural Research, National Institutes of Health, National Institute of Neurological Disorders and Stroke, Bethesda, MD (R.C.); the Section of General Thoracic Surgery, Columbia University Medical Center, New York (J.R.S.); the Department of Neurology, University at Buffalo Jacobs School of Medicine and Biomedical Sciences, Buffalo (G.I.W.).'}, {'ForeName': 'Jan J G', 'Initials': 'JJG', 'LastName': 'Verschuuren', 'Affiliation': 'From the Department of Neurology, University of Alabama at Birmingham, Birmingham (I.L.); the Department of Biostatistics, University of Alabama at Birmingham, Birmingham (H.-C.K., I.B.A., G.R.C., T.M., G.M); the Department of Neurology, George Washington University School of Medicine and Health Sciences, Washington, DC (H.J.K.); the Department of Neurology, Greater Manchester Neuroscience Center, Salford, Greater Manchester, UK (J.S.); the Institute of Pathology, University Medical Center Göttingen, Göttingen (P.S.); the Department of Neurology, McGill University, Montreal (C.H.C.), and the Division of Neurology, University of British Columbia, Vancouver (J. Oger) - both in Canada; the Department of Neurology, University of Chile, Santiago (G.C.); the Division of Neurology, Department of Medicine, University of Cape Town, Cape Town, South Africa (J.M.H.); the Department of Neurosciences, Mental Health and Sensory Organs, Sapienza University of Rome (G.A.), the Department of Neurology, Catholic University, (A.E.) - both in Rome; the Department of Neurology, Johannes Gutenberg University, Mainz, Germany (W.N.); the Department of Neurology, University of Rochester Medical Center, Rochester, New York (E.C.); the Division of Neurology, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand (R.W.); the Department of Neurology, Royal Melbourne Hospital, Victoria, Australia (J.O.K.); the Department of Neurology, University of Southern California, Los Angeles (S.R.B.), and the Department of Neurology, University of California Irvine Medical Center, Orange (T.M.) - both in California; the Department of Neurology, Medical College of Wisconsin, Milwaukee (A.C.B.); the Department of Neurology, Harvard Medical School, Boston (A.A.A.); Nerve and Muscle Center of Texas, Houston (A.I.S.), and the Department of Neurology, University of Texas Health Science Center, San Antonio (C.E.J.) - both in Texas; the Department of Neurology, Case Western Reserve University, Cleveland (B.K.), and the Department of Neurology, Ohio State University Wexner Medical Center, Columbus (J.T.K.) - both in Ohio; Walton Centre for Neurology and Neurosurgery, Liverpool (B.R.F.L.), and Nuffield Department of Clinical Neurosciences, Oxford University, Oxford (C.B., A.V.) - both in the United Kingdom; Unit of Neurology, University of Brasilia, Brasilia (E.D.-T.), the Department of Neurology, Federal University, Rio de Janeiro (M.W.-C.), and the Department of Neurology, Universidade Federal do Parana, Curitiba (L.C.W.) - all in Brazil; the Department of Neurology, Kanazawa University, Kanazawa, Japan (H.Y.); the Department of Neurology, University of Florida, Jacksonville (M.T.P.), and the Department of Neurology, University of Miami, Miami (M.B.) - both in Florida; the Department of Neurology, Augusta University, Augusta (M.H.R.); the Department of Neurology, Medical University of Warsaw, Warsaw, Poland (A.K.-P.); the Department of Neurology, Indiana School of Medicine, Indianapolis (R.M.P.); the Department of Neurology, Leiden University Medical Center, Leiden, the Netherlands (J.J.G.M.V.); the Department of Neurology, Duke University Medical Center, Durham, NC (J.M.M.); the Department of Neurology, University of Kansas Medical Center, Kansas City (R.J.B.); the Department of Neurological Sciences, University of Vermont College of Medicine, Burlington (R.T.); the Division of Extramural Research, National Institutes of Health, National Institute of Neurological Disorders and Stroke, Bethesda, MD (R.C.); the Section of General Thoracic Surgery, Columbia University Medical Center, New York (J.R.S.); the Department of Neurology, University at Buffalo Jacobs School of Medicine and Biomedical Sciences, Buffalo (G.I.W.).'}, {'ForeName': 'Janice M', 'Initials': 'JM', 'LastName': 'Massey', 'Affiliation': 'From the Department of Neurology, University of Alabama at Birmingham, Birmingham (I.L.); the Department of Biostatistics, University of Alabama at Birmingham, Birmingham (H.-C.K., I.B.A., G.R.C., T.M., G.M); the Department of Neurology, George Washington University School of Medicine and Health Sciences, Washington, DC (H.J.K.); the Department of Neurology, Greater Manchester Neuroscience Center, Salford, Greater Manchester, UK (J.S.); the Institute of Pathology, University Medical Center Göttingen, Göttingen (P.S.); the Department of Neurology, McGill University, Montreal (C.H.C.), and the Division of Neurology, University of British Columbia, Vancouver (J. Oger) - both in Canada; the Department of Neurology, University of Chile, Santiago (G.C.); the Division of Neurology, Department of Medicine, University of Cape Town, Cape Town, South Africa (J.M.H.); the Department of Neurosciences, Mental Health and Sensory Organs, Sapienza University of Rome (G.A.), the Department of Neurology, Catholic University, (A.E.) - both in Rome; the Department of Neurology, Johannes Gutenberg University, Mainz, Germany (W.N.); the Department of Neurology, University of Rochester Medical Center, Rochester, New York (E.C.); the Division of Neurology, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand (R.W.); the Department of Neurology, Royal Melbourne Hospital, Victoria, Australia (J.O.K.); the Department of Neurology, University of Southern California, Los Angeles (S.R.B.), and the Department of Neurology, University of California Irvine Medical Center, Orange (T.M.) - both in California; the Department of Neurology, Medical College of Wisconsin, Milwaukee (A.C.B.); the Department of Neurology, Harvard Medical School, Boston (A.A.A.); Nerve and Muscle Center of Texas, Houston (A.I.S.), and the Department of Neurology, University of Texas Health Science Center, San Antonio (C.E.J.) - both in Texas; the Department of Neurology, Case Western Reserve University, Cleveland (B.K.), and the Department of Neurology, Ohio State University Wexner Medical Center, Columbus (J.T.K.) - both in Ohio; Walton Centre for Neurology and Neurosurgery, Liverpool (B.R.F.L.), and Nuffield Department of Clinical Neurosciences, Oxford University, Oxford (C.B., A.V.) - both in the United Kingdom; Unit of Neurology, University of Brasilia, Brasilia (E.D.-T.), the Department of Neurology, Federal University, Rio de Janeiro (M.W.-C.), and the Department of Neurology, Universidade Federal do Parana, Curitiba (L.C.W.) - all in Brazil; the Department of Neurology, Kanazawa University, Kanazawa, Japan (H.Y.); the Department of Neurology, University of Florida, Jacksonville (M.T.P.), and the Department of Neurology, University of Miami, Miami (M.B.) - both in Florida; the Department of Neurology, Augusta University, Augusta (M.H.R.); the Department of Neurology, Medical University of Warsaw, Warsaw, Poland (A.K.-P.); the Department of Neurology, Indiana School of Medicine, Indianapolis (R.M.P.); the Department of Neurology, Leiden University Medical Center, Leiden, the Netherlands (J.J.G.M.V.); the Department of Neurology, Duke University Medical Center, Durham, NC (J.M.M.); the Department of Neurology, University of Kansas Medical Center, Kansas City (R.J.B.); the Department of Neurological Sciences, University of Vermont College of Medicine, Burlington (R.T.); the Division of Extramural Research, National Institutes of Health, National Institute of Neurological Disorders and Stroke, Bethesda, MD (R.C.); the Section of General Thoracic Surgery, Columbia University Medical Center, New York (J.R.S.); the Department of Neurology, University at Buffalo Jacobs School of Medicine and Biomedical Sciences, Buffalo (G.I.W.).'}, {'ForeName': 'John T', 'Initials': 'JT', 'LastName': 'Kissel', 'Affiliation': 'From the Department of Neurology, University of Alabama at Birmingham, Birmingham (I.L.); the Department of Biostatistics, University of Alabama at Birmingham, Birmingham (H.-C.K., I.B.A., G.R.C., T.M., G.M); the Department of Neurology, George Washington University School of Medicine and Health Sciences, Washington, DC (H.J.K.); the Department of Neurology, Greater Manchester Neuroscience Center, Salford, Greater Manchester, UK (J.S.); the Institute of Pathology, University Medical Center Göttingen, Göttingen (P.S.); the Department of Neurology, McGill University, Montreal (C.H.C.), and the Division of Neurology, University of British Columbia, Vancouver (J. Oger) - both in Canada; the Department of Neurology, University of Chile, Santiago (G.C.); the Division of Neurology, Department of Medicine, University of Cape Town, Cape Town, South Africa (J.M.H.); the Department of Neurosciences, Mental Health and Sensory Organs, Sapienza University of Rome (G.A.), the Department of Neurology, Catholic University, (A.E.) - both in Rome; the Department of Neurology, Johannes Gutenberg University, Mainz, Germany (W.N.); the Department of Neurology, University of Rochester Medical Center, Rochester, New York (E.C.); the Division of Neurology, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand (R.W.); the Department of Neurology, Royal Melbourne Hospital, Victoria, Australia (J.O.K.); the Department of Neurology, University of Southern California, Los Angeles (S.R.B.), and the Department of Neurology, University of California Irvine Medical Center, Orange (T.M.) - both in California; the Department of Neurology, Medical College of Wisconsin, Milwaukee (A.C.B.); the Department of Neurology, Harvard Medical School, Boston (A.A.A.); Nerve and Muscle Center of Texas, Houston (A.I.S.), and the Department of Neurology, University of Texas Health Science Center, San Antonio (C.E.J.) - both in Texas; the Department of Neurology, Case Western Reserve University, Cleveland (B.K.), and the Department of Neurology, Ohio State University Wexner Medical Center, Columbus (J.T.K.) - both in Ohio; Walton Centre for Neurology and Neurosurgery, Liverpool (B.R.F.L.), and Nuffield Department of Clinical Neurosciences, Oxford University, Oxford (C.B., A.V.) - both in the United Kingdom; Unit of Neurology, University of Brasilia, Brasilia (E.D.-T.), the Department of Neurology, Federal University, Rio de Janeiro (M.W.-C.), and the Department of Neurology, Universidade Federal do Parana, Curitiba (L.C.W.) - all in Brazil; the Department of Neurology, Kanazawa University, Kanazawa, Japan (H.Y.); the Department of Neurology, University of Florida, Jacksonville (M.T.P.), and the Department of Neurology, University of Miami, Miami (M.B.) - both in Florida; the Department of Neurology, Augusta University, Augusta (M.H.R.); the Department of Neurology, Medical University of Warsaw, Warsaw, Poland (A.K.-P.); the Department of Neurology, Indiana School of Medicine, Indianapolis (R.M.P.); the Department of Neurology, Leiden University Medical Center, Leiden, the Netherlands (J.J.G.M.V.); the Department of Neurology, Duke University Medical Center, Durham, NC (J.M.M.); the Department of Neurology, University of Kansas Medical Center, Kansas City (R.J.B.); the Department of Neurological Sciences, University of Vermont College of Medicine, Burlington (R.T.); the Division of Extramural Research, National Institutes of Health, National Institute of Neurological Disorders and Stroke, Bethesda, MD (R.C.); the Section of General Thoracic Surgery, Columbia University Medical Center, New York (J.R.S.); the Department of Neurology, University at Buffalo Jacobs School of Medicine and Biomedical Sciences, Buffalo (G.I.W.).'}, {'ForeName': 'Lineu C', 'Initials': 'LC', 'LastName': 'Werneck', 'Affiliation': 'From the Department of Neurology, University of Alabama at Birmingham, Birmingham (I.L.); the Department of Biostatistics, University of Alabama at Birmingham, Birmingham (H.-C.K., I.B.A., G.R.C., T.M., G.M); the Department of Neurology, George Washington University School of Medicine and Health Sciences, Washington, DC (H.J.K.); the Department of Neurology, Greater Manchester Neuroscience Center, Salford, Greater Manchester, UK (J.S.); the Institute of Pathology, University Medical Center Göttingen, Göttingen (P.S.); the Department of Neurology, McGill University, Montreal (C.H.C.), and the Division of Neurology, University of British Columbia, Vancouver (J. Oger) - both in Canada; the Department of Neurology, University of Chile, Santiago (G.C.); the Division of Neurology, Department of Medicine, University of Cape Town, Cape Town, South Africa (J.M.H.); the Department of Neurosciences, Mental Health and Sensory Organs, Sapienza University of Rome (G.A.), the Department of Neurology, Catholic University, (A.E.) - both in Rome; the Department of Neurology, Johannes Gutenberg University, Mainz, Germany (W.N.); the Department of Neurology, University of Rochester Medical Center, Rochester, New York (E.C.); the Division of Neurology, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand (R.W.); the Department of Neurology, Royal Melbourne Hospital, Victoria, Australia (J.O.K.); the Department of Neurology, University of Southern California, Los Angeles (S.R.B.), and the Department of Neurology, University of California Irvine Medical Center, Orange (T.M.) - both in California; the Department of Neurology, Medical College of Wisconsin, Milwaukee (A.C.B.); the Department of Neurology, Harvard Medical School, Boston (A.A.A.); Nerve and Muscle Center of Texas, Houston (A.I.S.), and the Department of Neurology, University of Texas Health Science Center, San Antonio (C.E.J.) - both in Texas; the Department of Neurology, Case Western Reserve University, Cleveland (B.K.), and the Department of Neurology, Ohio State University Wexner Medical Center, Columbus (J.T.K.) - both in Ohio; Walton Centre for Neurology and Neurosurgery, Liverpool (B.R.F.L.), and Nuffield Department of Clinical Neurosciences, Oxford University, Oxford (C.B., A.V.) - both in the United Kingdom; Unit of Neurology, University of Brasilia, Brasilia (E.D.-T.), the Department of Neurology, Federal University, Rio de Janeiro (M.W.-C.), and the Department of Neurology, Universidade Federal do Parana, Curitiba (L.C.W.) - all in Brazil; the Department of Neurology, Kanazawa University, Kanazawa, Japan (H.Y.); the Department of Neurology, University of Florida, Jacksonville (M.T.P.), and the Department of Neurology, University of Miami, Miami (M.B.) - both in Florida; the Department of Neurology, Augusta University, Augusta (M.H.R.); the Department of Neurology, Medical University of Warsaw, Warsaw, Poland (A.K.-P.); the Department of Neurology, Indiana School of Medicine, Indianapolis (R.M.P.); the Department of Neurology, Leiden University Medical Center, Leiden, the Netherlands (J.J.G.M.V.); the Department of Neurology, Duke University Medical Center, Durham, NC (J.M.M.); the Department of Neurology, University of Kansas Medical Center, Kansas City (R.J.B.); the Department of Neurological Sciences, University of Vermont College of Medicine, Burlington (R.T.); the Division of Extramural Research, National Institutes of Health, National Institute of Neurological Disorders and Stroke, Bethesda, MD (R.C.); the Section of General Thoracic Surgery, Columbia University Medical Center, New York (J.R.S.); the Department of Neurology, University at Buffalo Jacobs School of Medicine and Biomedical Sciences, Buffalo (G.I.W.).'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Benatar', 'Affiliation': 'From the Department of Neurology, University of Alabama at Birmingham, Birmingham (I.L.); the Department of Biostatistics, University of Alabama at Birmingham, Birmingham (H.-C.K., I.B.A., G.R.C., T.M., G.M); the Department of Neurology, George Washington University School of Medicine and Health Sciences, Washington, DC (H.J.K.); the Department of Neurology, Greater Manchester Neuroscience Center, Salford, Greater Manchester, UK (J.S.); the Institute of Pathology, University Medical Center Göttingen, Göttingen (P.S.); the Department of Neurology, McGill University, Montreal (C.H.C.), and the Division of Neurology, University of British Columbia, Vancouver (J. Oger) - both in Canada; the Department of Neurology, University of Chile, Santiago (G.C.); the Division of Neurology, Department of Medicine, University of Cape Town, Cape Town, South Africa (J.M.H.); the Department of Neurosciences, Mental Health and Sensory Organs, Sapienza University of Rome (G.A.), the Department of Neurology, Catholic University, (A.E.) - both in Rome; the Department of Neurology, Johannes Gutenberg University, Mainz, Germany (W.N.); the Department of Neurology, University of Rochester Medical Center, Rochester, New York (E.C.); the Division of Neurology, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand (R.W.); the Department of Neurology, Royal Melbourne Hospital, Victoria, Australia (J.O.K.); the Department of Neurology, University of Southern California, Los Angeles (S.R.B.), and the Department of Neurology, University of California Irvine Medical Center, Orange (T.M.) - both in California; the Department of Neurology, Medical College of Wisconsin, Milwaukee (A.C.B.); the Department of Neurology, Harvard Medical School, Boston (A.A.A.); Nerve and Muscle Center of Texas, Houston (A.I.S.), and the Department of Neurology, University of Texas Health Science Center, San Antonio (C.E.J.) - both in Texas; the Department of Neurology, Case Western Reserve University, Cleveland (B.K.), and the Department of Neurology, Ohio State University Wexner Medical Center, Columbus (J.T.K.) - both in Ohio; Walton Centre for Neurology and Neurosurgery, Liverpool (B.R.F.L.), and Nuffield Department of Clinical Neurosciences, Oxford University, Oxford (C.B., A.V.) - both in the United Kingdom; Unit of Neurology, University of Brasilia, Brasilia (E.D.-T.), the Department of Neurology, Federal University, Rio de Janeiro (M.W.-C.), and the Department of Neurology, Universidade Federal do Parana, Curitiba (L.C.W.) - all in Brazil; the Department of Neurology, Kanazawa University, Kanazawa, Japan (H.Y.); the Department of Neurology, University of Florida, Jacksonville (M.T.P.), and the Department of Neurology, University of Miami, Miami (M.B.) - both in Florida; the Department of Neurology, Augusta University, Augusta (M.H.R.); the Department of Neurology, Medical University of Warsaw, Warsaw, Poland (A.K.-P.); the Department of Neurology, Indiana School of Medicine, Indianapolis (R.M.P.); the Department of Neurology, Leiden University Medical Center, Leiden, the Netherlands (J.J.G.M.V.); the Department of Neurology, Duke University Medical Center, Durham, NC (J.M.M.); the Department of Neurology, University of Kansas Medical Center, Kansas City (R.J.B.); the Department of Neurological Sciences, University of Vermont College of Medicine, Burlington (R.T.); the Division of Extramural Research, National Institutes of Health, National Institute of Neurological Disorders and Stroke, Bethesda, MD (R.C.); the Section of General Thoracic Surgery, Columbia University Medical Center, New York (J.R.S.); the Department of Neurology, University at Buffalo Jacobs School of Medicine and Biomedical Sciences, Buffalo (G.I.W.).'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'Barohn', 'Affiliation': 'From the Department of Neurology, University of Alabama at Birmingham, Birmingham (I.L.); the Department of Biostatistics, University of Alabama at Birmingham, Birmingham (H.-C.K., I.B.A., G.R.C., T.M., G.M); the Department of Neurology, George Washington University School of Medicine and Health Sciences, Washington, DC (H.J.K.); the Department of Neurology, Greater Manchester Neuroscience Center, Salford, Greater Manchester, UK (J.S.); the Institute of Pathology, University Medical Center Göttingen, Göttingen (P.S.); the Department of Neurology, McGill University, Montreal (C.H.C.), and the Division of Neurology, University of British Columbia, Vancouver (J. Oger) - both in Canada; the Department of Neurology, University of Chile, Santiago (G.C.); the Division of Neurology, Department of Medicine, University of Cape Town, Cape Town, South Africa (J.M.H.); the Department of Neurosciences, Mental Health and Sensory Organs, Sapienza University of Rome (G.A.), the Department of Neurology, Catholic University, (A.E.) - both in Rome; the Department of Neurology, Johannes Gutenberg University, Mainz, Germany (W.N.); the Department of Neurology, University of Rochester Medical Center, Rochester, New York (E.C.); the Division of Neurology, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand (R.W.); the Department of Neurology, Royal Melbourne Hospital, Victoria, Australia (J.O.K.); the Department of Neurology, University of Southern California, Los Angeles (S.R.B.), and the Department of Neurology, University of California Irvine Medical Center, Orange (T.M.) - both in California; the Department of Neurology, Medical College of Wisconsin, Milwaukee (A.C.B.); the Department of Neurology, Harvard Medical School, Boston (A.A.A.); Nerve and Muscle Center of Texas, Houston (A.I.S.), and the Department of Neurology, University of Texas Health Science Center, San Antonio (C.E.J.) - both in Texas; the Department of Neurology, Case Western Reserve University, Cleveland (B.K.), and the Department of Neurology, Ohio State University Wexner Medical Center, Columbus (J.T.K.) - both in Ohio; Walton Centre for Neurology and Neurosurgery, Liverpool (B.R.F.L.), and Nuffield Department of Clinical Neurosciences, Oxford University, Oxford (C.B., A.V.) - both in the United Kingdom; Unit of Neurology, University of Brasilia, Brasilia (E.D.-T.), the Department of Neurology, Federal University, Rio de Janeiro (M.W.-C.), and the Department of Neurology, Universidade Federal do Parana, Curitiba (L.C.W.) - all in Brazil; the Department of Neurology, Kanazawa University, Kanazawa, Japan (H.Y.); the Department of Neurology, University of Florida, Jacksonville (M.T.P.), and the Department of Neurology, University of Miami, Miami (M.B.) - both in Florida; the Department of Neurology, Augusta University, Augusta (M.H.R.); the Department of Neurology, Medical University of Warsaw, Warsaw, Poland (A.K.-P.); the Department of Neurology, Indiana School of Medicine, Indianapolis (R.M.P.); the Department of Neurology, Leiden University Medical Center, Leiden, the Netherlands (J.J.G.M.V.); the Department of Neurology, Duke University Medical Center, Durham, NC (J.M.M.); the Department of Neurology, University of Kansas Medical Center, Kansas City (R.J.B.); the Department of Neurological Sciences, University of Vermont College of Medicine, Burlington (R.T.); the Division of Extramural Research, National Institutes of Health, National Institute of Neurological Disorders and Stroke, Bethesda, MD (R.C.); the Section of General Thoracic Surgery, Columbia University Medical Center, New York (J.R.S.); the Department of Neurology, University at Buffalo Jacobs School of Medicine and Biomedical Sciences, Buffalo (G.I.W.).'}, {'ForeName': 'Rup', 'Initials': 'R', 'LastName': 'Tandan', 'Affiliation': 'From the Department of Neurology, University of Alabama at Birmingham, Birmingham (I.L.); the Department of Biostatistics, University of Alabama at Birmingham, Birmingham (H.-C.K., I.B.A., G.R.C., T.M., G.M); the Department of Neurology, George Washington University School of Medicine and Health Sciences, Washington, DC (H.J.K.); the Department of Neurology, Greater Manchester Neuroscience Center, Salford, Greater Manchester, UK (J.S.); the Institute of Pathology, University Medical Center Göttingen, Göttingen (P.S.); the Department of Neurology, McGill University, Montreal (C.H.C.), and the Division of Neurology, University of British Columbia, Vancouver (J. Oger) - both in Canada; the Department of Neurology, University of Chile, Santiago (G.C.); the Division of Neurology, Department of Medicine, University of Cape Town, Cape Town, South Africa (J.M.H.); the Department of Neurosciences, Mental Health and Sensory Organs, Sapienza University of Rome (G.A.), the Department of Neurology, Catholic University, (A.E.) - both in Rome; the Department of Neurology, Johannes Gutenberg University, Mainz, Germany (W.N.); the Department of Neurology, University of Rochester Medical Center, Rochester, New York (E.C.); the Division of Neurology, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand (R.W.); the Department of Neurology, Royal Melbourne Hospital, Victoria, Australia (J.O.K.); the Department of Neurology, University of Southern California, Los Angeles (S.R.B.), and the Department of Neurology, University of California Irvine Medical Center, Orange (T.M.) - both in California; the Department of Neurology, Medical College of Wisconsin, Milwaukee (A.C.B.); the Department of Neurology, Harvard Medical School, Boston (A.A.A.); Nerve and Muscle Center of Texas, Houston (A.I.S.), and the Department of Neurology, University of Texas Health Science Center, San Antonio (C.E.J.) - both in Texas; the Department of Neurology, Case Western Reserve University, Cleveland (B.K.), and the Department of Neurology, Ohio State University Wexner Medical Center, Columbus (J.T.K.) - both in Ohio; Walton Centre for Neurology and Neurosurgery, Liverpool (B.R.F.L.), and Nuffield Department of Clinical Neurosciences, Oxford University, Oxford (C.B., A.V.) - both in the United Kingdom; Unit of Neurology, University of Brasilia, Brasilia (E.D.-T.), the Department of Neurology, Federal University, Rio de Janeiro (M.W.-C.), and the Department of Neurology, Universidade Federal do Parana, Curitiba (L.C.W.) - all in Brazil; the Department of Neurology, Kanazawa University, Kanazawa, Japan (H.Y.); the Department of Neurology, University of Florida, Jacksonville (M.T.P.), and the Department of Neurology, University of Miami, Miami (M.B.) - both in Florida; the Department of Neurology, Augusta University, Augusta (M.H.R.); the Department of Neurology, Medical University of Warsaw, Warsaw, Poland (A.K.-P.); the Department of Neurology, Indiana School of Medicine, Indianapolis (R.M.P.); the Department of Neurology, Leiden University Medical Center, Leiden, the Netherlands (J.J.G.M.V.); the Department of Neurology, Duke University Medical Center, Durham, NC (J.M.M.); the Department of Neurology, University of Kansas Medical Center, Kansas City (R.J.B.); the Department of Neurological Sciences, University of Vermont College of Medicine, Burlington (R.T.); the Division of Extramural Research, National Institutes of Health, National Institute of Neurological Disorders and Stroke, Bethesda, MD (R.C.); the Section of General Thoracic Surgery, Columbia University Medical Center, New York (J.R.S.); the Department of Neurology, University at Buffalo Jacobs School of Medicine and Biomedical Sciences, Buffalo (G.I.W.).'}, {'ForeName': 'Tahseen', 'Initials': 'T', 'LastName': 'Mozaffar', 'Affiliation': 'From the Department of Neurology, University of Alabama at Birmingham, Birmingham (I.L.); the Department of Biostatistics, University of Alabama at Birmingham, Birmingham (H.-C.K., I.B.A., G.R.C., T.M., G.M); the Department of Neurology, George Washington University School of Medicine and Health Sciences, Washington, DC (H.J.K.); the Department of Neurology, Greater Manchester Neuroscience Center, Salford, Greater Manchester, UK (J.S.); the Institute of Pathology, University Medical Center Göttingen, Göttingen (P.S.); the Department of Neurology, McGill University, Montreal (C.H.C.), and the Division of Neurology, University of British Columbia, Vancouver (J. Oger) - both in Canada; the Department of Neurology, University of Chile, Santiago (G.C.); the Division of Neurology, Department of Medicine, University of Cape Town, Cape Town, South Africa (J.M.H.); the Department of Neurosciences, Mental Health and Sensory Organs, Sapienza University of Rome (G.A.), the Department of Neurology, Catholic University, (A.E.) - both in Rome; the Department of Neurology, Johannes Gutenberg University, Mainz, Germany (W.N.); the Department of Neurology, University of Rochester Medical Center, Rochester, New York (E.C.); the Division of Neurology, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand (R.W.); the Department of Neurology, Royal Melbourne Hospital, Victoria, Australia (J.O.K.); the Department of Neurology, University of Southern California, Los Angeles (S.R.B.), and the Department of Neurology, University of California Irvine Medical Center, Orange (T.M.) - both in California; the Department of Neurology, Medical College of Wisconsin, Milwaukee (A.C.B.); the Department of Neurology, Harvard Medical School, Boston (A.A.A.); Nerve and Muscle Center of Texas, Houston (A.I.S.), and the Department of Neurology, University of Texas Health Science Center, San Antonio (C.E.J.) - both in Texas; the Department of Neurology, Case Western Reserve University, Cleveland (B.K.), and the Department of Neurology, Ohio State University Wexner Medical Center, Columbus (J.T.K.) - both in Ohio; Walton Centre for Neurology and Neurosurgery, Liverpool (B.R.F.L.), and Nuffield Department of Clinical Neurosciences, Oxford University, Oxford (C.B., A.V.) - both in the United Kingdom; Unit of Neurology, University of Brasilia, Brasilia (E.D.-T.), the Department of Neurology, Federal University, Rio de Janeiro (M.W.-C.), and the Department of Neurology, Universidade Federal do Parana, Curitiba (L.C.W.) - all in Brazil; the Department of Neurology, Kanazawa University, Kanazawa, Japan (H.Y.); the Department of Neurology, University of Florida, Jacksonville (M.T.P.), and the Department of Neurology, University of Miami, Miami (M.B.) - both in Florida; the Department of Neurology, Augusta University, Augusta (M.H.R.); the Department of Neurology, Medical University of Warsaw, Warsaw, Poland (A.K.-P.); the Department of Neurology, Indiana School of Medicine, Indianapolis (R.M.P.); the Department of Neurology, Leiden University Medical Center, Leiden, the Netherlands (J.J.G.M.V.); the Department of Neurology, Duke University Medical Center, Durham, NC (J.M.M.); the Department of Neurology, University of Kansas Medical Center, Kansas City (R.J.B.); the Department of Neurological Sciences, University of Vermont College of Medicine, Burlington (R.T.); the Division of Extramural Research, National Institutes of Health, National Institute of Neurological Disorders and Stroke, Bethesda, MD (R.C.); the Section of General Thoracic Surgery, Columbia University Medical Center, New York (J.R.S.); the Department of Neurology, University at Buffalo Jacobs School of Medicine and Biomedical Sciences, Buffalo (G.I.W.).'}, {'ForeName': 'Robin', 'Initials': 'R', 'LastName': 'Conwit', 'Affiliation': 'From the Department of Neurology, University of Alabama at Birmingham, Birmingham (I.L.); the Department of Biostatistics, University of Alabama at Birmingham, Birmingham (H.-C.K., I.B.A., G.R.C., T.M., G.M); the Department of Neurology, George Washington University School of Medicine and Health Sciences, Washington, DC (H.J.K.); the Department of Neurology, Greater Manchester Neuroscience Center, Salford, Greater Manchester, UK (J.S.); the Institute of Pathology, University Medical Center Göttingen, Göttingen (P.S.); the Department of Neurology, McGill University, Montreal (C.H.C.), and the Division of Neurology, University of British Columbia, Vancouver (J. Oger) - both in Canada; the Department of Neurology, University of Chile, Santiago (G.C.); the Division of Neurology, Department of Medicine, University of Cape Town, Cape Town, South Africa (J.M.H.); the Department of Neurosciences, Mental Health and Sensory Organs, Sapienza University of Rome (G.A.), the Department of Neurology, Catholic University, (A.E.) - both in Rome; the Department of Neurology, Johannes Gutenberg University, Mainz, Germany (W.N.); the Department of Neurology, University of Rochester Medical Center, Rochester, New York (E.C.); the Division of Neurology, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand (R.W.); the Department of Neurology, Royal Melbourne Hospital, Victoria, Australia (J.O.K.); the Department of Neurology, University of Southern California, Los Angeles (S.R.B.), and the Department of Neurology, University of California Irvine Medical Center, Orange (T.M.) - both in California; the Department of Neurology, Medical College of Wisconsin, Milwaukee (A.C.B.); the Department of Neurology, Harvard Medical School, Boston (A.A.A.); Nerve and Muscle Center of Texas, Houston (A.I.S.), and the Department of Neurology, University of Texas Health Science Center, San Antonio (C.E.J.) - both in Texas; the Department of Neurology, Case Western Reserve University, Cleveland (B.K.), and the Department of Neurology, Ohio State University Wexner Medical Center, Columbus (J.T.K.) - both in Ohio; Walton Centre for Neurology and Neurosurgery, Liverpool (B.R.F.L.), and Nuffield Department of Clinical Neurosciences, Oxford University, Oxford (C.B., A.V.) - both in the United Kingdom; Unit of Neurology, University of Brasilia, Brasilia (E.D.-T.), the Department of Neurology, Federal University, Rio de Janeiro (M.W.-C.), and the Department of Neurology, Universidade Federal do Parana, Curitiba (L.C.W.) - all in Brazil; the Department of Neurology, Kanazawa University, Kanazawa, Japan (H.Y.); the Department of Neurology, University of Florida, Jacksonville (M.T.P.), and the Department of Neurology, University of Miami, Miami (M.B.) - both in Florida; the Department of Neurology, Augusta University, Augusta (M.H.R.); the Department of Neurology, Medical University of Warsaw, Warsaw, Poland (A.K.-P.); the Department of Neurology, Indiana School of Medicine, Indianapolis (R.M.P.); the Department of Neurology, Leiden University Medical Center, Leiden, the Netherlands (J.J.G.M.V.); the Department of Neurology, Duke University Medical Center, Durham, NC (J.M.M.); the Department of Neurology, University of Kansas Medical Center, Kansas City (R.J.B.); the Department of Neurological Sciences, University of Vermont College of Medicine, Burlington (R.T.); the Division of Extramural Research, National Institutes of Health, National Institute of Neurological Disorders and Stroke, Bethesda, MD (R.C.); the Section of General Thoracic Surgery, Columbia University Medical Center, New York (J.R.S.); the Department of Neurology, University at Buffalo Jacobs School of Medicine and Biomedical Sciences, Buffalo (G.I.W.).'}, {'ForeName': 'Greg', 'Initials': 'G', 'LastName': 'Minisman', 'Affiliation': 'From the Department of Neurology, University of Alabama at Birmingham, Birmingham (I.L.); the Department of Biostatistics, University of Alabama at Birmingham, Birmingham (H.-C.K., I.B.A., G.R.C., T.M., G.M); the Department of Neurology, George Washington University School of Medicine and Health Sciences, Washington, DC (H.J.K.); the Department of Neurology, Greater Manchester Neuroscience Center, Salford, Greater Manchester, UK (J.S.); the Institute of Pathology, University Medical Center Göttingen, Göttingen (P.S.); the Department of Neurology, McGill University, Montreal (C.H.C.), and the Division of Neurology, University of British Columbia, Vancouver (J. Oger) - both in Canada; the Department of Neurology, University of Chile, Santiago (G.C.); the Division of Neurology, Department of Medicine, University of Cape Town, Cape Town, South Africa (J.M.H.); the Department of Neurosciences, Mental Health and Sensory Organs, Sapienza University of Rome (G.A.), the Department of Neurology, Catholic University, (A.E.) - both in Rome; the Department of Neurology, Johannes Gutenberg University, Mainz, Germany (W.N.); the Department of Neurology, University of Rochester Medical Center, Rochester, New York (E.C.); the Division of Neurology, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand (R.W.); the Department of Neurology, Royal Melbourne Hospital, Victoria, Australia (J.O.K.); the Department of Neurology, University of Southern California, Los Angeles (S.R.B.), and the Department of Neurology, University of California Irvine Medical Center, Orange (T.M.) - both in California; the Department of Neurology, Medical College of Wisconsin, Milwaukee (A.C.B.); the Department of Neurology, Harvard Medical School, Boston (A.A.A.); Nerve and Muscle Center of Texas, Houston (A.I.S.), and the Department of Neurology, University of Texas Health Science Center, San Antonio (C.E.J.) - both in Texas; the Department of Neurology, Case Western Reserve University, Cleveland (B.K.), and the Department of Neurology, Ohio State University Wexner Medical Center, Columbus (J.T.K.) - both in Ohio; Walton Centre for Neurology and Neurosurgery, Liverpool (B.R.F.L.), and Nuffield Department of Clinical Neurosciences, Oxford University, Oxford (C.B., A.V.) - both in the United Kingdom; Unit of Neurology, University of Brasilia, Brasilia (E.D.-T.), the Department of Neurology, Federal University, Rio de Janeiro (M.W.-C.), and the Department of Neurology, Universidade Federal do Parana, Curitiba (L.C.W.) - all in Brazil; the Department of Neurology, Kanazawa University, Kanazawa, Japan (H.Y.); the Department of Neurology, University of Florida, Jacksonville (M.T.P.), and the Department of Neurology, University of Miami, Miami (M.B.) - both in Florida; the Department of Neurology, Augusta University, Augusta (M.H.R.); the Department of Neurology, Medical University of Warsaw, Warsaw, Poland (A.K.-P.); the Department of Neurology, Indiana School of Medicine, Indianapolis (R.M.P.); the Department of Neurology, Leiden University Medical Center, Leiden, the Netherlands (J.J.G.M.V.); the Department of Neurology, Duke University Medical Center, Durham, NC (J.M.M.); the Department of Neurology, University of Kansas Medical Center, Kansas City (R.J.B.); the Department of Neurological Sciences, University of Vermont College of Medicine, Burlington (R.T.); the Division of Extramural Research, National Institutes of Health, National Institute of Neurological Disorders and Stroke, Bethesda, MD (R.C.); the Section of General Thoracic Surgery, Columbia University Medical Center, New York (J.R.S.); the Department of Neurology, University at Buffalo Jacobs School of Medicine and Biomedical Sciences, Buffalo (G.I.W.).'}, {'ForeName': 'Joshua R', 'Initials': 'JR', 'LastName': 'Sonett', 'Affiliation': 'From the Department of Neurology, University of Alabama at Birmingham, Birmingham (I.L.); the Department of Biostatistics, University of Alabama at Birmingham, Birmingham (H.-C.K., I.B.A., G.R.C., T.M., G.M); the Department of Neurology, George Washington University School of Medicine and Health Sciences, Washington, DC (H.J.K.); the Department of Neurology, Greater Manchester Neuroscience Center, Salford, Greater Manchester, UK (J.S.); the Institute of Pathology, University Medical Center Göttingen, Göttingen (P.S.); the Department of Neurology, McGill University, Montreal (C.H.C.), and the Division of Neurology, University of British Columbia, Vancouver (J. Oger) - both in Canada; the Department of Neurology, University of Chile, Santiago (G.C.); the Division of Neurology, Department of Medicine, University of Cape Town, Cape Town, South Africa (J.M.H.); the Department of Neurosciences, Mental Health and Sensory Organs, Sapienza University of Rome (G.A.), the Department of Neurology, Catholic University, (A.E.) - both in Rome; the Department of Neurology, Johannes Gutenberg University, Mainz, Germany (W.N.); the Department of Neurology, University of Rochester Medical Center, Rochester, New York (E.C.); the Division of Neurology, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand (R.W.); the Department of Neurology, Royal Melbourne Hospital, Victoria, Australia (J.O.K.); the Department of Neurology, University of Southern California, Los Angeles (S.R.B.), and the Department of Neurology, University of California Irvine Medical Center, Orange (T.M.) - both in California; the Department of Neurology, Medical College of Wisconsin, Milwaukee (A.C.B.); the Department of Neurology, Harvard Medical School, Boston (A.A.A.); Nerve and Muscle Center of Texas, Houston (A.I.S.), and the Department of Neurology, University of Texas Health Science Center, San Antonio (C.E.J.) - both in Texas; the Department of Neurology, Case Western Reserve University, Cleveland (B.K.), and the Department of Neurology, Ohio State University Wexner Medical Center, Columbus (J.T.K.) - both in Ohio; Walton Centre for Neurology and Neurosurgery, Liverpool (B.R.F.L.), and Nuffield Department of Clinical Neurosciences, Oxford University, Oxford (C.B., A.V.) - both in the United Kingdom; Unit of Neurology, University of Brasilia, Brasilia (E.D.-T.), the Department of Neurology, Federal University, Rio de Janeiro (M.W.-C.), and the Department of Neurology, Universidade Federal do Parana, Curitiba (L.C.W.) - all in Brazil; the Department of Neurology, Kanazawa University, Kanazawa, Japan (H.Y.); the Department of Neurology, University of Florida, Jacksonville (M.T.P.), and the Department of Neurology, University of Miami, Miami (M.B.) - both in Florida; the Department of Neurology, Augusta University, Augusta (M.H.R.); the Department of Neurology, Medical University of Warsaw, Warsaw, Poland (A.K.-P.); the Department of Neurology, Indiana School of Medicine, Indianapolis (R.M.P.); the Department of Neurology, Leiden University Medical Center, Leiden, the Netherlands (J.J.G.M.V.); the Department of Neurology, Duke University Medical Center, Durham, NC (J.M.M.); the Department of Neurology, University of Kansas Medical Center, Kansas City (R.J.B.); the Department of Neurological Sciences, University of Vermont College of Medicine, Burlington (R.T.); the Division of Extramural Research, National Institutes of Health, National Institute of Neurological Disorders and Stroke, Bethesda, MD (R.C.); the Section of General Thoracic Surgery, Columbia University Medical Center, New York (J.R.S.); the Department of Neurology, University at Buffalo Jacobs School of Medicine and Biomedical Sciences, Buffalo (G.I.W.).'}, {'ForeName': 'Gil I', 'Initials': 'GI', 'LastName': 'Wolfe', 'Affiliation': 'From the Department of Neurology, University of Alabama at Birmingham, Birmingham (I.L.); the Department of Biostatistics, University of Alabama at Birmingham, Birmingham (H.-C.K., I.B.A., G.R.C., T.M., G.M); the Department of Neurology, George Washington University School of Medicine and Health Sciences, Washington, DC (H.J.K.); the Department of Neurology, Greater Manchester Neuroscience Center, Salford, Greater Manchester, UK (J.S.); the Institute of Pathology, University Medical Center Göttingen, Göttingen (P.S.); the Department of Neurology, McGill University, Montreal (C.H.C.), and the Division of Neurology, University of British Columbia, Vancouver (J. Oger) - both in Canada; the Department of Neurology, University of Chile, Santiago (G.C.); the Division of Neurology, Department of Medicine, University of Cape Town, Cape Town, South Africa (J.M.H.); the Department of Neurosciences, Mental Health and Sensory Organs, Sapienza University of Rome (G.A.), the Department of Neurology, Catholic University, (A.E.) - both in Rome; the Department of Neurology, Johannes Gutenberg University, Mainz, Germany (W.N.); the Department of Neurology, University of Rochester Medical Center, Rochester, New York (E.C.); the Division of Neurology, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand (R.W.); the Department of Neurology, Royal Melbourne Hospital, Victoria, Australia (J.O.K.); the Department of Neurology, University of Southern California, Los Angeles (S.R.B.), and the Department of Neurology, University of California Irvine Medical Center, Orange (T.M.) - both in California; the Department of Neurology, Medical College of Wisconsin, Milwaukee (A.C.B.); the Department of Neurology, Harvard Medical School, Boston (A.A.A.); Nerve and Muscle Center of Texas, Houston (A.I.S.), and the Department of Neurology, University of Texas Health Science Center, San Antonio (C.E.J.) - both in Texas; the Department of Neurology, Case Western Reserve University, Cleveland (B.K.), and the Department of Neurology, Ohio State University Wexner Medical Center, Columbus (J.T.K.) - both in Ohio; Walton Centre for Neurology and Neurosurgery, Liverpool (B.R.F.L.), and Nuffield Department of Clinical Neurosciences, Oxford University, Oxford (C.B., A.V.) - both in the United Kingdom; Unit of Neurology, University of Brasilia, Brasilia (E.D.-T.), the Department of Neurology, Federal University, Rio de Janeiro (M.W.-C.), and the Department of Neurology, Universidade Federal do Parana, Curitiba (L.C.W.) - all in Brazil; the Department of Neurology, Kanazawa University, Kanazawa, Japan (H.Y.); the Department of Neurology, University of Florida, Jacksonville (M.T.P.), and the Department of Neurology, University of Miami, Miami (M.B.) - both in Florida; the Department of Neurology, Augusta University, Augusta (M.H.R.); the Department of Neurology, Medical University of Warsaw, Warsaw, Poland (A.K.-P.); the Department of Neurology, Indiana School of Medicine, Indianapolis (R.M.P.); the Department of Neurology, Leiden University Medical Center, Leiden, the Netherlands (J.J.G.M.V.); the Department of Neurology, Duke University Medical Center, Durham, NC (J.M.M.); the Department of Neurology, University of Kansas Medical Center, Kansas City (R.J.B.); the Department of Neurological Sciences, University of Vermont College of Medicine, Burlington (R.T.); the Division of Extramural Research, National Institutes of Health, National Institute of Neurological Disorders and Stroke, Bethesda, MD (R.C.); the Section of General Thoracic Surgery, Columbia University Medical Center, New York (J.R.S.); the Department of Neurology, University at Buffalo Jacobs School of Medicine and Biomedical Sciences, Buffalo (G.I.W.).'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Neurology,['10.1212/WNL.0000000000010031'] 3006,32611643,Suitability of external controls for drug evaluation in Duchenne muscular dystrophy.,"OBJECTIVE To evaluate the suitability of real-world data (RWD) and natural history data (NHD) for use as external controls in drug evaluations for ambulatory Duchenne muscular dystrophy (DMD). METHODS The consistency of changes in the six-minute walk distance (Δ6MWD) was compared across multiple clinical trial placebo arms and sources of NHD/RWD. Six placebo arms reporting 48-week Δ6MWD were identified via literature review and represented four sets of inclusion/exclusion criteria (n=383 patients, in total). Five sources of RWD/NHD were contributed by Universitaire Ziekenhuizen Leuven, DMD Italian Group, Cooperative International Neuromuscular Research Group, ImagingDMD, and the PRO-DMD-01 study (n=430 patients, in total). Mean Δ6MWD was compared between each placebo arm and RWD/NHD source after subjecting the latter to the trial's inclusion/exclusion criteria for baseline age, ambulatory function, and steroid use. Baseline covariate adjustment was investigated in a subset of patients with available data. RESULTS Analyses included ∼1,200 patient-years of follow-up. Differences in mean Δ6MWD between trial placebo arms and RWD/NHD cohorts ranged from -19.4 meters (i.e., better outcomes in RWD/NHD) to 19.5 meters (i.e., worse outcomes in RWD/NHD), and were not statistically significant before or after covariate adjustment. CONCLUSIONS Δ6MWD was consistent between placebo arms and RWD/NHD subjected to equivalent inclusion/exclusion criteria. No evidence for systematic bias was detected. These findings are encouraging for the use of RWD/NHD to augment, or possibly replace, placebo controls in DMD trials. Multi-institution collaboration through the collaborative Trajectory Analysis Project rendered this study feasible.",2020,The consistency of changes in the six-minute walk distance (Δ6MWD) was compared across multiple clinical trial placebo arms and sources of NHD/RWD.,"['ambulatory Duchenne muscular dystrophy (DMD', 'Duchenne muscular dystrophy']","['real-world data (RWD) and natural history data (NHD', 'Six placebo', 'placebo']","['Mean Δ6MWD', 'mean Δ6MWD']","[{'cui': 'C0002424', 'cui_str': 'Ambulatory care site'}, {'cui': 'C0013264', 'cui_str': 'Duchenne muscular dystrophy'}]","[{'cui': 'C0175860', 'cui_str': 'Natural History'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}]","[{'cui': 'C0444504', 'cui_str': 'Mean'}]",430.0,0.447587,The consistency of changes in the six-minute walk distance (Δ6MWD) was compared across multiple clinical trial placebo arms and sources of NHD/RWD.,"[{'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Goemans', 'Affiliation': 'University Hospitals Leuven, Child Neurology, Leuven, Belgium.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Signorovitch', 'Affiliation': 'Analysis Group, Inc., Boston, MA, USA.'}, {'ForeName': 'Gautam', 'Initials': 'G', 'LastName': 'Sajeev', 'Affiliation': 'Analysis Group, Inc., Boston, MA, USA.'}, {'ForeName': 'Zhiwen', 'Initials': 'Z', 'LastName': 'Yao', 'Affiliation': 'Analysis Group, Inc., Boston, MA, USA.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Gordish-Dressman', 'Affiliation': ""Children's National Medical Center, Research Center for Genetic Medicine, Washington, DC, USA.""}, {'ForeName': 'Craig M', 'Initials': 'CM', 'LastName': 'McDonald', 'Affiliation': 'Department of Physical Medicine and Rehabilitation, and Pediatrics, University of California, Davis, Sacramento, California, USA.'}, {'ForeName': 'Krista', 'Initials': 'K', 'LastName': 'Vandenborne', 'Affiliation': 'Department of Physical Therapy, University of Florida, Gainesville, FL, USA.'}, {'ForeName': 'Debra', 'Initials': 'D', 'LastName': 'Miller', 'Affiliation': 'CureDuchenne, Newport Beach, CA, USA.'}, {'ForeName': 'Susan J', 'Initials': 'SJ', 'LastName': 'Ward', 'Affiliation': 'The Collaborative Trajectory Analysis Project, Cambridge, MA, USA.'}, {'ForeName': 'Eugenio', 'Initials': 'E', 'LastName': 'Mercuri', 'Affiliation': 'Department of Pediatric Neurology, Catholic University, Rome, Italy eumercuri@gmail.com.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Neurology,['10.1212/WNL.0000000000010170'] 3007,30734090,Oxytocin modulates the effective connectivity between the precuneus and the dorsolateral prefrontal cortex.,"Our social activity is heavily influenced by the process of introspection, with emerging research suggesting a role for the Default Mode Network (DMN) in social cognition. We hypothesize that oxytocin, a neuropeptide with an important role in social behaviour, can effectively alter the connectivity of the DMN. We test this hypothesis using a randomized, double-blind, crossover, placebo-controlled trial where 15 healthy male participants received 24 IU oxytocin or placebo prior to a resting-state functional MRI scan. We used Granger Causality Analysis for the first time to probe the role of oxytocin on brain networks and found that oxytocin reverses the pattern of effective connectivity between the bilateral precuneus and the left dorsolateral prefrontal cortex (dlPFC), a key central executive network (CEN) region. Under placebo, the bilateral precuneus exerted a significant negative causal influence on the left dlPFC and the left dlPFC exerted a significant positive causal influence on the bilateral precuneus. However, under oxytocin, these patterns were reversed, i.e. positive causal influence from the bilateral precuneus to the left dlPFC and negative causal influence from the left dlPFC to the bilateral precuneus (with statistically significant effects for the right precuneus). We propose that these oxytocin-induced effects could be a mechanistic process by which it modulates social cognition. These results provide a measurable target for the physiological effects of oxytocin in the brain and offer oxytocin as a potential agent to enhance the cooperative role of the predominantly 'task-inactive' 'default mode' brain regions in both healthy and patient populations.",2020,"Under placebo, the bilateral precuneus exerted a significant negative causal influence on the left dlPFC and the left dlPFC exerted a significant positive causal influence on the bilateral precuneus.","['15 healthy male participants received 24', 'prior to a resting-state functional MRI scan']","['IU oxytocin or placebo', 'oxytocin', 'placebo', 'Oxytocin']",[],"[{'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0376335', 'cui_str': 'fMRI'}, {'cui': 'C0441633'}]","[{'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]",[],15.0,0.0591017,"Under placebo, the bilateral precuneus exerted a significant negative causal influence on the left dlPFC and the left dlPFC exerted a significant positive causal influence on the bilateral precuneus.","[{'ForeName': 'Jyothika', 'Initials': 'J', 'LastName': 'Kumar', 'Affiliation': 'Division of Psychiatry and Applied Psychology, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Sarina J', 'Initials': 'SJ', 'LastName': 'Iwabuchi', 'Affiliation': 'Radiological Sciences, Division of Clinical Neuroscience, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Birgit A', 'Initials': 'BA', 'LastName': 'Völlm', 'Affiliation': 'Division of Psychiatry and Applied Psychology, University of Nottingham, Nottingham, UK.'}, {'ForeName': 'Lena', 'Initials': 'L', 'LastName': 'Palaniyappan', 'Affiliation': 'Division of Psychiatry and Applied Psychology, University of Nottingham, Nottingham, UK. lpalaniy@uwo.ca.'}]",European archives of psychiatry and clinical neuroscience,['10.1007/s00406-019-00989-z'] 3008,31311799,Compounded creams no better than placebo creams for localised chronic pain.,,2020,,['localised chronic pain'],['placebo creams'],[],"[{'cui': 'C0150055', 'cui_str': 'Chronic pain (finding)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]",[],,0.0927942,,"[{'ForeName': 'Jiale', 'Initials': 'J', 'LastName': 'Hu', 'Affiliation': 'Department of Nurse Anesthesia, Virginia Commonwealth University, Richmond, Virginia, USA.'}]",Evidence-based nursing,['10.1136/ebnurs-2019-103128'] 3009,30846854,"Development of patient ""profiles"" to tailor counseling for incidental genomic sequencing results.","Guidelines recommend that providers engage patients in shared decision-making about receiving incidental results (IR) prior to genomic sequencing (GS), but this can be time-consuming, given the myriad of IR and variation in patients' preferences. We aimed to develop patient profiles to inform pre-test counseling for IR. We conducted semi-structured interviews with participants as a part of a randomized trial of the GenomicsADvISER.com, a decision aid for selecting IR. Interviews explored factors participants considered when deliberating over learning IR. Interviews were analyzed by thematic analysis and constant comparison. Participants were mostly female (28/31) and about half of them were over the age of 50 (16/31). We identified five patient profiles that reflect common contextual factors, attitudes, concerns, and perceived utility of IR. Information Enthusiasts self-identified as ""planners"" and valued learning most or all IR to enable planning and disease prevention because ""knowledge is power"". Concerned Individuals defined themselves as ""anxious,"" and were reluctant to learn IR, anticipating negative psychological impacts from IR. Contemplators were discerning about the value and limitations of IR, weighing health benefits with the impacts of not being able to ""un-know"" information. Individuals of Advanced Life Stage did not consider IR relevant for themselves and primarily considered their implications for family members. Reassurance Seekers were reassured by previous negative genetic test results which shaped their expectations for receiving no IR: ""hopefully [GS will] be negative, too. And then I can rest easy"". These profiles could inform targeted counseling for IR by providing a framework to address common values, concerns. and misconceptions.",2019,"Information Enthusiasts self-identified as ""planners"" and valued learning most or all IR to enable planning and disease prevention because ""knowledge is power"".",['Participants were mostly female (28/31) and about half of them were over the age of 50 (16/31'],[],[],"[{'cui': 'C0086287', 'cui_str': 'Females'}]",[],[],,0.0159349,"Information Enthusiasts self-identified as ""planners"" and valued learning most or all IR to enable planning and disease prevention because ""knowledge is power"".","[{'ForeName': 'Chloe', 'Initials': 'C', 'LastName': 'Mighton', 'Affiliation': 'University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Lindsay', 'Initials': 'L', 'LastName': 'Carlsson', 'Affiliation': 'University Health Network, Toronto, ON, Canada.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Clausen', 'Affiliation': ""St. Michael's Hospital, Toronto, ON, Canada.""}, {'ForeName': 'Selina', 'Initials': 'S', 'LastName': 'Casalino', 'Affiliation': ""St. Michael's Hospital, Toronto, ON, Canada.""}, {'ForeName': 'Salma', 'Initials': 'S', 'LastName': 'Shickh', 'Affiliation': 'University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'McCuaig', 'Affiliation': 'University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Esha', 'Initials': 'E', 'LastName': 'Joshi', 'Affiliation': 'University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Seema', 'Initials': 'S', 'LastName': 'Panchal', 'Affiliation': 'Mount Sinai Hospital, Sinai Health System, Toronto, ON, Canada.'}, {'ForeName': 'Tracy', 'Initials': 'T', 'LastName': 'Graham', 'Affiliation': 'Sunnybrook Health Sciences Centre, Toronto, ON, Canada.'}, {'ForeName': 'Melyssa', 'Initials': 'M', 'LastName': 'Aronson', 'Affiliation': 'University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Carolyn', 'Initials': 'C', 'LastName': 'Piccinin', 'Affiliation': 'Mount Sinai Hospital, Sinai Health System, Toronto, ON, Canada.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Winter-Paquette', 'Affiliation': 'University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Kara', 'Initials': 'K', 'LastName': 'Semotiuk', 'Affiliation': 'University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Justin', 'Initials': 'J', 'LastName': 'Lorentz', 'Affiliation': 'Sunnybrook Health Sciences Centre, Toronto, ON, Canada.'}, {'ForeName': 'Talia', 'Initials': 'T', 'LastName': 'Mancuso', 'Affiliation': 'Sunnybrook Health Sciences Centre, Toronto, ON, Canada.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Ott', 'Affiliation': 'Sunnybrook Health Sciences Centre, Toronto, ON, Canada.'}, {'ForeName': 'Yael', 'Initials': 'Y', 'LastName': 'Silberman', 'Affiliation': 'Sunnybrook Health Sciences Centre, Toronto, ON, Canada.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Elser', 'Affiliation': 'University Health Network, Toronto, ON, Canada.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Eisen', 'Affiliation': 'Sunnybrook Health Sciences Centre, Toronto, ON, Canada.'}, {'ForeName': 'Raymond H', 'Initials': 'RH', 'LastName': 'Kim', 'Affiliation': 'University Health Network, Toronto, ON, Canada.'}, {'ForeName': 'Jordan', 'Initials': 'J', 'LastName': 'Lerner-Ellis', 'Affiliation': 'University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'June C', 'Initials': 'JC', 'LastName': 'Carroll', 'Affiliation': 'University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Emily', 'Initials': 'E', 'LastName': 'Glogowski', 'Affiliation': 'GeneDx, Gaithersburg, MD, USA.'}, {'ForeName': 'Kasmintan', 'Initials': 'K', 'LastName': 'Schrader', 'Affiliation': 'BC Cancer Agency, Vancouver, BC, Canada.'}, {'ForeName': 'Yvonne', 'Initials': 'Y', 'LastName': 'Bombard', 'Affiliation': 'University of Toronto, Toronto, ON, Canada. yvonne.bombard@utoronto.ca.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",European journal of human genetics : EJHG,['10.1038/s41431-019-0352-2'] 3010,31502228,Question prompts to empower cancer patients: results of a randomized controlled trial.,"OBJECTIVE In addition to question prompts for information transfer, we also used prompts to facilitate the expression of emotions. Our aim was to investigate how a question prompt list (QPL) is accepted by patients and whether it enhances interactional empowerment of the patients in the consultation with the radio-oncological treatment team before the beginning of radiotherapy. METHODOLOGY Adult cancer patients before the beginning of radiotherapy were randomly assigned to the intervention group (IG) or control group (CG). The patients in the IG received a QPL with predefined subsets and subject areas. After the physician's consultation, both groups completed a self-developed, content validated questionnaire on interactional empowerment. The IG evaluated the QPL using a self-developed instrument. RESULT A total of 279 adult cancer patients participated in the study (IG n = 139/CG n = 140). The participants of the IG reported a significantly higher interactional empowerment compared with those of the CG (t(277) = - 2.71, p = .007, 95% CI [- 1.61, - 0.26], d = 0.29). 60.4% of the IG agreed ""rather"" or ""very"" that they used the QPL in consultation with the medical team. CONCLUSION The QPL used in the consultation improved the self-assessed competence for interaction with the medical team and strengthened the interactional empowerment. The QPL was well accepted by the patients and is to be introduced into a routine as a practicable and simple instrument in the future. The support of patients in addressing concerns and fears is an important innovation.",2020,The QPL used in the consultation improved the self-assessed competence for interaction with the medical team and strengthened the interactional empowerment.,"['279 adult cancer patients participated in the study (IG n\u2009', 'empower cancer patients', 'Adult cancer patients before the beginning of']","['radiotherapy', 'intervention group (IG) or control group (CG']",['interactional empowerment'],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0562342', 'cui_str': 'Empowered (finding)'}]","[{'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0679959', 'cui_str': 'Empowerment'}]",279.0,0.0331898,The QPL used in the consultation improved the self-assessed competence for interaction with the medical team and strengthened the interactional empowerment.,"[{'ForeName': 'T', 'Initials': 'T', 'LastName': 'Zetzl', 'Affiliation': 'Interdisciplinary Centre for palliative medicine, University Hospital Wuerzburg, Wuerzburg, Germany. Zetzl_T@ukw.de.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Mann', 'Affiliation': 'Interdisciplinary Centre for palliative medicine, University Hospital Wuerzburg, Wuerzburg, Germany.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Gruner', 'Affiliation': 'Interdisciplinary Centre for palliative medicine, University Hospital Wuerzburg, Wuerzburg, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Schuler', 'Affiliation': 'Department of Psychotherapy and Medical Psychology, Rehabilitation Sciences Section, University of Wuerzburg, Wuerzburg, Germany.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Jentschke', 'Affiliation': 'Interdisciplinary Centre for palliative medicine, University Hospital Wuerzburg, Wuerzburg, Germany.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Neuderth', 'Affiliation': 'Department of Applied Social Sciences, University of Applied Sciences Wuerzburg-Schweinfurt, Wuerzburg, Germany.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Roch', 'Affiliation': 'Interdisciplinary Centre for palliative medicine, University Hospital Wuerzburg, Wuerzburg, Germany.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'van Oorschot', 'Affiliation': 'Interdisciplinary Centre for palliative medicine, University Hospital Wuerzburg, Wuerzburg, Germany.'}]",Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer,['10.1007/s00520-019-05036-0'] 3011,31502945,User Experience Affects Dropout from Internet-Delivered Dialectical Behavior Therapy.,"Background: The emergence of computerized treatment may help reduce the gap between mental health treatment needs and accessibility, but unfortunately, dropout from these interventions is often high. Introduction: To increase the effectiveness of computerized interventions and reduce dropout, particularly among high-risk and clinically complex populations, better understanding of how usable and acceptable (i.e., user experience) these interventions are, informed by human computer interaction research, is needed. This study examines user experience of internet-delivered dialectical behavior therapy (iDBT). The major aim is to explore whether treatment dropout was affected by the complexity of population and/or user experience. Methods: Secondary analyses were conducted using data from a randomized controlled trial that evaluated iDBT in a sample of 59 suicidal and heavy episodic drinkers. Multivariate logistic regression and chi-square tests were performed to examine the roles of clinical characteristics and user experience in differentiating dropouts and nondropouts. Results: The only significant pretreatment predictor of dropout was the presence of a barrier, with technological and unknown barriers being most strongly associated with dropping. No clinical characteristics emerged as significant predictors of dropout. Discussion: The current results highlight technological problems as a possible barrier to adherence to computerized interventions. Future research would profit from increased integration of human-computer interaction to identify and solve user experience problems.",2020,"The only significant pretreatment predictor of dropout was the presence of a barrier, with technological and unknown barriers being most strongly associated with dropping.",['59 suicidal and heavy episodic drinkers'],"['iDBT', 'internet-delivered dialectical behavior therapy (iDBT']",[],"[{'cui': 'C0438696', 'cui_str': 'Suicidal (finding)'}, {'cui': 'C0439539', 'cui_str': 'Heavy sensation quality'}, {'cui': 'C0556335', 'cui_str': 'Binge drinker (finding)'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C1321145', 'cui_str': 'Dialectical Behavior Therapy'}]",[],59.0,0.0343292,"The only significant pretreatment predictor of dropout was the presence of a barrier, with technological and unknown barriers being most strongly associated with dropping.","[{'ForeName': 'Chelsey R', 'Initials': 'CR', 'LastName': 'Wilks', 'Affiliation': 'Department of Psychology, Harvard University, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Qingqing', 'Initials': 'Q', 'LastName': 'Yin', 'Affiliation': 'Department of Psychology, Eastern Michigan University, Ypsilanti, Michigan, USA.'}, {'ForeName': 'Kelly L', 'Initials': 'KL', 'LastName': 'Zuromski', 'Affiliation': 'Department of Psychology, Harvard University, Cambridge, Massachusetts, USA.'}]",Telemedicine journal and e-health : the official journal of the American Telemedicine Association,['10.1089/tmj.2019.0124'] 3012,31543515,"Comment on ""Hyaluronic acid injection in glans penis for treatment of premature ejaculation: a randomized controlled cross-over study"".",,2020,,['premature ejaculation'],['Hyaluronic acid injection'],[],"[{'cui': 'C0033038', 'cui_str': 'Ejaculatio Praecox'}]","[{'cui': 'C1141990', 'cui_str': 'Hyaluronic acid'}, {'cui': 'C1272883', 'cui_str': 'Injection'}]",[],,0.0438367,,"[{'ForeName': 'Murat', 'Initials': 'M', 'LastName': 'Gul', 'Affiliation': 'Department of Urology, Aksaray University School of Medicine, Aksaray, Turkey. drmuratgul@hotmail.com.'}]",International journal of impotence research,['10.1038/s41443-019-0200-5'] 3013,31931509,The acute effects of nicotine on corticostriatal responses to distinct phases of reward processing.,"Nicotine enhances the reinforcement of non-drug rewards by increasing nucleus accumbens (NAcc) reactivity to anticipatory cues. This anticipatory effect is selective as no clear evidence has emerged showing that nicotine acutely changes reward receipt reactivity. However, repeated rewarding experiences shift peak brain reactivity from hedonic reward outcome to the motivational anticipatory cue yielding more habitual cue-induced behavior. Given nicotine's influence on NAcc reactivity and connectivity, it is plausible that nicotine acutely induces this shift and alters NAcc functional connectivity during reward processing. To evaluate this currently untested hypothesis, a randomized crossover design was used in which healthy non-smokers were administered placebo and nicotine (2-mg lozenge). Brain activation to monetary reward anticipation and outcome was evaluated with functional magnetic resonance imaging. Relative to placebo, nicotine induced more NAcc reactivity to reward anticipation. Greater NAcc activation during anticipation was significantly associated with lower NAcc activation to outcome. During outcome, nicotine reduced NAcc functional connectivity with cortical regions including the anterior cingulate cortex, orbitofrontal cortex, and insula. These regions showed the same negative relationship between reward anticipation and outcome as noted in the NAcc. The current findings significantly improve our understanding of how nicotine changes corticostriatal circuit function and communication during distinct phases of reward processing and critically show that these alterations happen acutely following a single dose. The implications of this work explain nicotinic modulation of general reward function, which offer insights into the initial drive to smoke and the subsequent difficulty in cessation.",2020,Nicotine enhances the reinforcement of non-drug rewards by increasing nucleus accumbens (NAcc) reactivity to anticipatory cues.,['healthy non-smokers'],"['nicotine', 'Nicotine', 'placebo and nicotine (2-mg lozenge', 'placebo, nicotine']","['anterior cingulate cortex, orbitofrontal cortex, and insula', 'Greater NAcc activation', 'habitual cue-induced behavior']","[{'cui': 'C4554605', 'cui_str': 'Nonsmokers'}]","[{'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4319836', 'cui_str': 'Lozenge'}]","[{'cui': 'C0175190', 'cui_str': 'Anterior Cingulate'}, {'cui': 'C2331062', 'cui_str': 'Orbital Area'}, {'cui': 'C0021640', 'cui_str': 'Insula of Reil'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0205353', 'cui_str': 'Habitual (qualifier value)'}, {'cui': 'C0010439', 'cui_str': 'Cues'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}]",,0.0321595,Nicotine enhances the reinforcement of non-drug rewards by increasing nucleus accumbens (NAcc) reactivity to anticipatory cues.,"[{'ForeName': 'Kainan S', 'Initials': 'KS', 'LastName': 'Wang', 'Affiliation': 'McLean Imaging Center, McLean Hospital, Belmont, MA, USA.'}, {'ForeName': 'Maya', 'Initials': 'M', 'LastName': 'Zegel', 'Affiliation': 'McLean Imaging Center, McLean Hospital, Belmont, MA, USA.'}, {'ForeName': 'Elena', 'Initials': 'E', 'LastName': 'Molokotos', 'Affiliation': 'McLean Imaging Center, McLean Hospital, Belmont, MA, USA.'}, {'ForeName': 'Lauren V', 'Initials': 'LV', 'LastName': 'Moran', 'Affiliation': 'McLean Imaging Center, McLean Hospital, Belmont, MA, USA.'}, {'ForeName': 'David P', 'Initials': 'DP', 'LastName': 'Olson', 'Affiliation': 'McLean Imaging Center, McLean Hospital, Belmont, MA, USA.'}, {'ForeName': 'Diego A', 'Initials': 'DA', 'LastName': 'Pizzagalli', 'Affiliation': 'McLean Imaging Center, McLean Hospital, Belmont, MA, USA.'}, {'ForeName': 'Amy C', 'Initials': 'AC', 'LastName': 'Janes', 'Affiliation': 'McLean Imaging Center, McLean Hospital, Belmont, MA, USA. ajanes@mclean.harvard.edu.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-020-0611-5'] 3014,31696371,Efficacy is Not Everything: Eliciting Women's Preferences for a Vaginal HIV Prevention Product Using a Discrete-Choice Experiment.,"As new female-initiated HIV prevention products enter development, it is crucial to incorporate women's preferences to ensure products will be desired, accepted, and used. A discrete-choice experiment was designed to assess the relative importance of six attributes to stated choice of a vaginally delivered HIV prevention product. Sexually active women in South Africa and Zimbabwe aged 18-30 were recruited from two samples: product-experienced women from a randomized trial of four vaginal placebo forms and product-naïve community members. In a tablet-administered survey, 395 women chose between two hypothetical products over eight choice sets. Efficacy was the most important, but there were identifiable preferences among other attributes. Women preferred a product that also prevented pregnancy and caused some wetness (p < 0.001). They disliked a daily-use product (p = 0.002) and insertion by finger (p = 0.002). Although efficacy drove preference, wetness, pregnancy prevention, and dosing regimen were influential to stated choice of a product, and women were willing to trade some level of efficacy to have other more desired attributes.",2020,They disliked a daily-use product (p = 0.002) and insertion by finger (p = 0.002).,"['395 women chose between two hypothetical products over eight choice sets', 'forms and product-naïve community members', 'Sexually active women in South Africa and Zimbabwe aged 18-30 were recruited from two samples: product-experienced women']",['vaginal placebo'],['Efficacy'],"[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0036849', 'cui_str': 'Set'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0241028', 'cui_str': 'Sexually active (finding)'}, {'cui': 'C0037712', 'cui_str': 'Union of South Africa'}, {'cui': 'C0043476', 'cui_str': 'Southern Rhodesia'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}]","[{'cui': 'C4521343', 'cui_str': 'Vaginal (intended site)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]",[],395.0,0.0500323,They disliked a daily-use product (p = 0.002) and insertion by finger (p = 0.002).,"[{'ForeName': 'Erica N', 'Initials': 'EN', 'LastName': 'Browne', 'Affiliation': ""Women's Global Health Imperative, RTI International, 351 California Street, Suite 500, San Francisco, CA, 94104, USA. ebrowne@rti.org.""}, {'ForeName': 'Elizabeth T', 'Initials': 'ET', 'LastName': 'Montgomery', 'Affiliation': ""Women's Global Health Imperative, RTI International, 351 California Street, Suite 500, San Francisco, CA, 94104, USA.""}, {'ForeName': 'Carol', 'Initials': 'C', 'LastName': 'Mansfield', 'Affiliation': 'Health Solutions, RTI International, Research Triangle Park, NC, USA.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Boeri', 'Affiliation': 'Health Solutions, RTI International, Research Triangle Park, NC, USA.'}, {'ForeName': 'Brennan', 'Initials': 'B', 'LastName': 'Mange', 'Affiliation': 'Health Solutions, RTI International, Research Triangle Park, NC, USA.'}, {'ForeName': 'Mags', 'Initials': 'M', 'LastName': 'Beksinska', 'Affiliation': 'MatCH Research Unit (MRU), Faculty of Health Sciences, University of the Witwatersrand, Durban, South Africa.'}, {'ForeName': 'Jill L', 'Initials': 'JL', 'LastName': 'Schwartz', 'Affiliation': 'CONRAD, Eastern Virginia Medical School, Arlington, VA, USA.'}, {'ForeName': 'Meredith R', 'Initials': 'MR', 'LastName': 'Clark', 'Affiliation': 'CONRAD, Eastern Virginia Medical School, Arlington, VA, USA.'}, {'ForeName': 'Gustavo F', 'Initials': 'GF', 'LastName': 'Doncel', 'Affiliation': 'CONRAD, Eastern Virginia Medical School, Arlington, VA, USA.'}, {'ForeName': 'Jenni', 'Initials': 'J', 'LastName': 'Smit', 'Affiliation': 'MatCH Research Unit (MRU), Faculty of Health Sciences, University of the Witwatersrand, Durban, South Africa.'}, {'ForeName': 'Zvavahera M', 'Initials': 'ZM', 'LastName': 'Chirenje', 'Affiliation': 'University of Zimbabwe College of Health Sciences Clinical Trials Research Centre, Harare, Zimbabwe.'}, {'ForeName': 'Ariane', 'Initials': 'A', 'LastName': 'van der Straten', 'Affiliation': ""Women's Global Health Imperative, RTI International, 351 California Street, Suite 500, San Francisco, CA, 94104, USA.""}]",AIDS and behavior,['10.1007/s10461-019-02715-1'] 3015,31729836,"Less Pain, More Gain: Should Placebo Be a Clinical Therapeutic?",,2020,"Respectively defined as the therapeutic and harmful effects when given a physiologically inert treatment, placebo and nocebo effects can result from any type of medical intervention.",[],"['placebo', 'Placebo']",[],[],"[{'cui': 'C1696465', 'cui_str': 'placebo'}]",[],,0.118754,"Respectively defined as the therapeutic and harmful effects when given a physiologically inert treatment, placebo and nocebo effects can result from any type of medical intervention.","[{'ForeName': 'Stacy N', 'Initials': 'SN', 'LastName': 'Uchendu', 'Affiliation': 'Department of Internal Medicine (Rheumatology, Allergy, & Immunology) and Department of Immunobiology, Yale University, New Haven, Connecticut.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Wang', 'Affiliation': 'Department of Internal Medicine (Rheumatology, Allergy, & Immunology) and Department of Immunobiology, Yale University, New Haven, Connecticut.'}]","Arthritis & rheumatology (Hoboken, N.J.)",['10.1002/art.41168'] 3016,31768718,A Pilot Randomized Clinical Trial of a Multidisciplinary Intervention for Encopresis in Children with Autism Spectrum Disorder.,"Children with autism spectrum disorder (ASD) are often delayed in achieving bowel continence, resulting in negative outcomes. In this pilot trial, 20 children with ASD and encopresis were randomly assigned to multidisciplinary intervention for encopresis (MIE; n = 10) or a waitlist control group (n = 10). The MIE group was treated for constipation and received a 10-day behavioral intervention that utilized suppositories to produce predictable bowel movements that were reinforced. Caregivers were trained to implement the intervention. Results support the feasibility of clinical trials of MIE, with high enrolment, competition, attendance, and caregiver acceptability. Preliminary outcomes were positive, with six of 10 in the MIE group achieving continence by the end of treatment compared to 0 in the control group (p = 0.005).Registered at clinicaltrials.gov (https://clinicaltrials.gov); ID: NCT02383732.",2020,"Results support the feasibility of clinical trials of MIE, with high enrolment, competition, attendance, and caregiver acceptability.","['Children with autism spectrum disorder (ASD', 'Children with Autism Spectrum Disorder', '20 children with ASD and encopresis']","['Multidisciplinary Intervention', 'multidisciplinary intervention for encopresis (MIE; n\u2009=\u200910) or a waitlist control group', '10-day behavioral intervention that utilized suppositories']",['achieving continence'],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1510586', 'cui_str': 'Autism Spectrum Disorders'}, {'cui': 'C2945606', 'cui_str': 'Encopresis'}]","[{'cui': 'C2945606', 'cui_str': 'Encopresis'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0038854', 'cui_str': 'Suppository'}]",[],20.0,0.103712,"Results support the feasibility of clinical trials of MIE, with high enrolment, competition, attendance, and caregiver acceptability.","[{'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Lomas Mevers', 'Affiliation': 'Division of Autism & Related Disabilities, Emory University School of Medicine, Atlanta, USA. Joanna.lomasmevers@choa.org.'}, {'ForeName': 'Nathan A', 'Initials': 'NA', 'LastName': 'Call', 'Affiliation': 'Division of Autism & Related Disabilities, Emory University School of Medicine, Atlanta, USA.'}, {'ForeName': 'Kristina R', 'Initials': 'KR', 'LastName': 'Gerencser', 'Affiliation': 'Division of Autism & Related Disabilities, Emory University School of Medicine, Atlanta, USA.'}, {'ForeName': 'Mindy', 'Initials': 'M', 'LastName': 'Scheithauer', 'Affiliation': 'Division of Autism & Related Disabilities, Emory University School of Medicine, Atlanta, USA.'}, {'ForeName': 'Sarah J', 'Initials': 'SJ', 'LastName': 'Miller', 'Affiliation': ""Children's Hospital New Orleans, New Orleans, USA.""}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'Muething', 'Affiliation': 'Division of Autism & Related Disabilities, Emory University School of Medicine, Atlanta, USA.'}, {'ForeName': 'Shannon', 'Initials': 'S', 'LastName': 'Hewett', 'Affiliation': 'Division of Autism & Related Disabilities, Marcus Autism Center, 1920 Briarcliff Rd., Atlanta, GA, 30329, USA.'}, {'ForeName': 'Courtney', 'Initials': 'C', 'LastName': 'McCracken', 'Affiliation': 'Division of Autism & Related Disabilities, Emory University School of Medicine, Atlanta, USA.'}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Scahill', 'Affiliation': 'Division of Autism & Related Disabilities, Emory University School of Medicine, Atlanta, USA.'}, {'ForeName': 'Barbara O', 'Initials': 'BO', 'LastName': 'McElhanon', 'Affiliation': 'Division of Autism & Related Disabilities, Emory University School of Medicine, Atlanta, USA.'}]",Journal of autism and developmental disorders,['10.1007/s10803-019-04305-5'] 3017,31843269,"Safety and immunogenicity of a single dose of a tetravalent dengue vaccine with two different serotype-2 potencies in adults in Singapore: A phase 2, double-blind, randomised, controlled trial.","BACKGROUND Early formulations of Takeda's tetravalent dengue vaccine candidate (TAK-003) have demonstrated notably higher neutralizing antibody responses against serotype 2 than other serotypes. Here, we assessed the immunogenicity and tolerability in adults living in Singapore of two TAK-003 formulations: an early formulation, referred to as HD-TDV, and a new formulation with 10-fold lower serotype 2 potency, referred to as TDV (NCT02425098). METHODS Subjects aged 21-45 years were stratified by baseline dengue serostatus and randomised 1:1 to receive a single dose of either HD-TDV or TDV. Immunogenicity was evaluated at Days 15, 30, 90, 180, and 365 post-vaccination as geometric mean titres (GMTs) of neutralising antibodies and seropositivity rates. Viremia was assessed per vaccine strain. Solicited and unsolicited adverse events (AEs) were assessed by severity and causality. RESULTS Of 351 subjects randomised, 176 received HD-TDV and 175 received TDV. Peak GMTs against all serotypes were observed at Day 30, with highest GMTs against DENV-2 in both groups. In subjects seronegative at baseline, the response to DENV-2 was less dominant with TDV (Day 30 GMTs: 813 for TDV, 10,966 for HD-TDV). In these subjects, DENV-4 seropositivity rates and GMTs were higher with TDV (Day 30 GMTs: 58 for TDV, 21 for HD-TDV; seropositivity rates: 76% for TDV, 60% for HD-TDV). Viremia mainly occurred for TDV-2 in both vaccine groups, with a lower incidence in TDV recipients, and mostly resolved by Day 30. Both vaccine formulations showed an acceptable safety profile with similar overall rates of solicited and unsolicited AEs across vaccine groups. CONCLUSIONS These results suggest a more balanced immune response with the new formulation TDV compared with the early formulation HD-TDV, particularly in subjects who were seronegative prior to vaccination, and support the choice of the new formulation for the phase 3 efficacy assessment.",2020,"Both vaccine formulations showed an acceptable safety profile with similar overall rates of solicited and unsolicited AEs across vaccine groups. ","['351 subjects randomised, 176 received HD-TDV and 175 received', 'adults living in Singapore of two TAK-003 formulations', 'Subjects aged 21-45\xa0years', 'adults in Singapore']","['HD-TDV or TDV', 'TDV']","['geometric mean titres (GMTs) of neutralising antibodies and seropositivity rates', 'Safety and immunogenicity', 'Viremia', 'immunogenicity and tolerability', 'Immunogenicity', 'DENV-4 seropositivity rates and GMTs']","[{'cui': 'C4517605', 'cui_str': '175'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0037173', 'cui_str': 'Singapore'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]",[],"[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0475208', 'cui_str': 'TITR'}, {'cui': 'C1142254', 'cui_str': 'Neutralising antibodies'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0042749', 'cui_str': 'Viremia'}]",351.0,0.168021,"Both vaccine formulations showed an acceptable safety profile with similar overall rates of solicited and unsolicited AEs across vaccine groups. ","[{'ForeName': 'Vianney', 'Initials': 'V', 'LastName': 'Tricou', 'Affiliation': 'Takeda Pharmaceuticals International AG, Zurich, Switzerland. Electronic address: Vianney.tricou@takeda.com.'}, {'ForeName': 'Jenny G', 'Initials': 'JG', 'LastName': 'Low', 'Affiliation': 'Singapore General Hospital, Singapore.'}, {'ForeName': 'Helen M', 'Initials': 'HM', 'LastName': 'Oh', 'Affiliation': 'Changi General Hospital, Singapore.'}, {'ForeName': 'Yee-Sin', 'Initials': 'YS', 'LastName': 'Leo', 'Affiliation': 'National Centre for Infectious Disease NCID, Singapore; Tan Tock Seng Hospital, Singapore.'}, {'ForeName': 'Shirin', 'Initials': 'S', 'LastName': 'Kalimuddin', 'Affiliation': 'Singapore General Hospital, Singapore.'}, {'ForeName': 'Limin', 'Initials': 'L', 'LastName': 'Wijaya', 'Affiliation': 'Singapore General Hospital, Singapore.'}, {'ForeName': 'Junxiong', 'Initials': 'J', 'LastName': 'Pang', 'Affiliation': 'Tan Tock Seng Hospital, Singapore; Saw Swee Hock School of Public Health, National University of Singapore, Singapore.'}, {'ForeName': 'Li Min', 'Initials': 'LM', 'LastName': 'Ling', 'Affiliation': 'Tan Tock Seng Hospital, Singapore.'}, {'ForeName': 'Tau Hong', 'Initials': 'TH', 'LastName': 'Lee', 'Affiliation': 'Tan Tock Seng Hospital, Singapore.'}, {'ForeName': 'Manja', 'Initials': 'M', 'LastName': 'Brose', 'Affiliation': 'Takeda Pharmaceuticals International AG, Zurich, Switzerland.'}, {'ForeName': 'Yanee', 'Initials': 'Y', 'LastName': 'Hutagalung', 'Affiliation': 'Takeda Vaccines Pte Ltd, Singapore.'}, {'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Rauscher', 'Affiliation': 'Takeda Pharmaceuticals International AG, Zurich, Switzerland.'}, {'ForeName': 'Astrid', 'Initials': 'A', 'LastName': 'Borkowski', 'Affiliation': 'Takeda Pharmaceuticals International AG, Zurich, Switzerland.'}, {'ForeName': 'Derek', 'Initials': 'D', 'LastName': 'Wallace', 'Affiliation': 'Takeda Vaccines Inc., Cambridge, MA, USA.'}]",Vaccine,['10.1016/j.vaccine.2019.11.061'] 3018,31865357,Lack of Evidence for the Effect of Oxytocin on Placebo Analgesia and Nocebo Hyperalgesia.,,2020,,[],['Oxytocin'],[],[],"[{'cui': 'C0030095', 'cui_str': 'Oxytocin'}]",[],,0.510404,,"[{'ForeName': 'Cuizhen', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': 'Department of Psychology, National University of Singapore, Singapore, Singapore.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Huang', 'Affiliation': 'NUS Graduate School for Integrative Sciences and Engineering, National University of Singapore, Singapore, Singapore.'}, {'ForeName': 'Linqiu', 'Initials': 'L', 'LastName': 'Chen', 'Affiliation': 'School of Psychology and Center for Studies of Psychological Application, South China Normal University, Guangzhou, China.'}, {'ForeName': 'Rongjun', 'Initials': 'R', 'LastName': 'Yu', 'Affiliation': 'Department of Psychology, National University of Singapore, Singapore, Singapore, psyyr@nus.edu.sg.'}]",Psychotherapy and psychosomatics,['10.1159/000504967'] 3019,31821154,Understanding Implementation of a Digital Self-Monitoring Intervention for Relapse Prevention in Psychosis: Protocol for a Mixed Method Process Evaluation.,"BACKGROUND Relapse is common in people who experience psychosis and is associated with many negative consequences, both societal and personal. People who relapse often exhibit changes (early warning signs [EWS]) in the period before relapse. Successful identification of EWS offers an opportunity for relapse prevention. However, several known barriers impede the use of EWS monitoring approaches. Early signs Monitoring to Prevent relapse in psychosis and prOmote Well-being, Engagement, and Recovery (EMPOWER) is a complex digital intervention that uses a mobile app to enhance the detection and management of self-reported changes in well-being. This is currently being tested in a pilot cluster randomized controlled trial. As digital interventions have not been widely used in relapse prevention, little is known about their implementation. Process evaluation studies run in parallel to clinical trials can provide valuable data on intervention feasibility. OBJECTIVE This study aims to transparently describe the protocol for the process evaluation element of the EMPOWER trial. We will focus on the development of a process evaluation framework sensitive to the worldview of service users, mental health staff, and carers; the aims of the process evaluation itself; the proposed studies to address these aims; and a plan for integration of results from separate process evaluation studies into one overall report. METHODS The overall process evaluation will utilize mixed methods across 6 substudies. Among them, 4 will use qualitative methodologies, 1 will use a mixed methods approach, and 1 will use quantitative methodologies. RESULTS The results of all studies will be triangulated into an overall analysis and interpretation of key implementation lessons. EMPOWER was funded in 2016, recruitment finished in January 2018. Data analysis is currently under way and the first results are expected to be submitted for publication in December 2019. CONCLUSIONS The findings from this study will help identify implementation facilitators and barriers to EMPOWER. These insights will inform both upscaling decisions and optimization of a definitive trial. TRIAL REGISTRATION ISRCTN Registry ISRCTN99559262; http://www.isrctn.com/ISRCTN99559262. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID) DERR1-10.2196/15634.",2019,"Early signs Monitoring to Prevent relapse in psychosis and prOmote Well-being, Engagement, and Recovery (EMPOWER) is a complex digital intervention that uses a mobile app to enhance the detection and management of self-reported changes in well-being.","['Psychosis', 'people who experience psychosis']","['Digital Self-Monitoring Intervention', 'EWS']",[],"[{'cui': 'C0033975', 'cui_str': 'Psychoses'}]","[{'cui': 'C0442015', 'cui_str': 'Digital X-ray (qualifier value)'}, {'cui': 'C0588436', 'cui_str': 'Self-monitoring (regime/therapy)'}]",[],,0.209626,"Early signs Monitoring to Prevent relapse in psychosis and prOmote Well-being, Engagement, and Recovery (EMPOWER) is a complex digital intervention that uses a mobile app to enhance the detection and management of self-reported changes in well-being.","[{'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Allan', 'Affiliation': 'Mental Health & Wellbeing, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Hamish', 'Initials': 'H', 'LastName': 'Mcleod', 'Affiliation': 'Mental Health & Wellbeing, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Bradstreet', 'Affiliation': 'Mental Health & Wellbeing, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Beedie', 'Affiliation': 'Mental Health & Wellbeing, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'Bethany', 'Initials': 'B', 'LastName': 'Moir', 'Affiliation': 'Mental Health & Wellbeing, University of Glasgow, Glasgow, United Kingdom.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Gleeson', 'Affiliation': 'School of Behavioural and Health Sciences, Australian Catholic University, Melbourne, Australia.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Farhall', 'Affiliation': 'Department of Psychology and Counselling, La Trobe University, Melbourne, Australia.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Morton', 'Affiliation': 'School of Behavioural and Health Sciences, Australian Catholic University, Melbourne, Australia.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Gumley', 'Affiliation': 'Mental Health & Wellbeing, University of Glasgow, Glasgow, United Kingdom.'}]",JMIR research protocols,['10.2196/15634'] 3020,31816478,Differential antiseizure medication sensitivity of the Affective Reactivity Index: A randomized controlled trial in new-onset pediatric focal epilepsy.,"BACKGROUND Irritability is a adverse effect of many antiseizure medications (ASMs), but there are no validated measures currently available to characterize this behavioral risk. We examined both child and parent/guardian versions of the Affective Reactivity Index (ARI), a validated measure developed for application in adolescent psychiatry, to determine its sensitivity to ASM-related irritability. We hypothesized irritability increases associated with levetiracetam (LEV) but not lamotrigine (LTG) or oxcarbazepine (OXC). METHOD The ARI was administered to 71 child and parent/guardian pairs randomized to one of three common ASMs (LEV, LTG, OXC) used to treat new-onset focal (localization-related) epilepsy. Subjects were recruited as part of a prospective multicenter, randomized, open-label, parallel group design. The ARI was administered at baseline prior to treatment initiation and again at 3 months after ASM initiation. RESULTS There was a significant increase in ARI ratings for both child and parent/guardian ratings for LEV but not LTG or OXC when assessed 3 months after treatment initiation. When examined on the individual subject level using a criterion of at least a 3-point ARI increase, there was an increase associated with LEV for child ratings but not parent/guardian scores. CONCLUSION Both child and parent/guardian versions of the ARI appear sensitive to medication-induced irritability associated with LEV on both the group and individual levels. The findings extend the applicability of ARI from characterizing the presence of clinical irritability as a psychiatric diagnostic feature to a more modifiable aspect of behavior change related to medication management and support its use in clinical trial applications.",2020,There was a significant increase in ARI ratings for both child and parent/guardian ratings for LEV but not LTG or OXC when assessed 3 months after treatment initiation.,[],"['lamotrigine (LTG) or oxcarbazepine (OXC', 'levetiracetam (LEV', 'three common ASMs (LEV, LTG, OXC']","['Affective Reactivity Index (ARI', 'ARI ratings', 'Affective Reactivity Index']",[],"[{'cui': 'C0064636', 'cui_str': 'lamotrigine'}, {'cui': 'C0069751', 'cui_str': 'oxcarbazepine'}, {'cui': 'C0377265', 'cui_str': 'Levetiracetam'}, {'cui': 'C0205214', 'cui_str': 'Common (qualifier value)'}, {'cui': 'C4521846', 'cui_str': 'Vice Admiral'}]","[{'cui': 'C0600653', 'cui_str': 'Indexes'}]",,0.0220179,There was a significant increase in ARI ratings for both child and parent/guardian ratings for LEV but not LTG or OXC when assessed 3 months after treatment initiation.,"[{'ForeName': 'David W', 'Initials': 'DW', 'LastName': 'Loring', 'Affiliation': 'Departments of Neurology and Pediatrics, Emory University, Atlanta, GA, United States of America. Electronic address: dloring@emory.edu.'}, {'ForeName': 'Kimford J', 'Initials': 'KJ', 'LastName': 'Meador', 'Affiliation': 'Department of Neurology & Neurological Sciences, Stanford University, Palo Alto, CA, United States of America.'}, {'ForeName': 'Shlomo', 'Initials': 'S', 'LastName': 'Shinnar', 'Affiliation': 'Departments of Neurology, Pediatrics, Epidemiology & Population Health, Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, NY, United States of America.'}, {'ForeName': 'William Davis', 'Initials': 'WD', 'LastName': 'Gaillard', 'Affiliation': ""Department of Neurology, Children's National Health System, Washington, DC, United States of America.""}, {'ForeName': 'James W', 'Initials': 'JW', 'LastName': 'Wheless', 'Affiliation': ""Department of Pediatrics, Division of Neurology, University of Tennessee Health Science Center, Le Bonheur Children's Hospital, Memphis, TN, United States of America.""}, {'ForeName': 'Sudha K', 'Initials': 'SK', 'LastName': 'Kessler', 'Affiliation': ""Division of Neurology, Children's Hospital of Philadelphia, Departments of Neurology and Pediatrics, University of Pennsylvania, Philadelphia, PA, United States of America.""}, {'ForeName': 'Joan A', 'Initials': 'JA', 'LastName': 'Conry', 'Affiliation': ""Department of Neurology, Children's National Health System, Washington, DC, United States of America.""}, {'ForeName': 'Madison M', 'Initials': 'MM', 'LastName': 'Berl', 'Affiliation': ""Department of Neuropsychology, Children's National Health System, Washington, DC, United States of America.""}, {'ForeName': 'Thomas G', 'Initials': 'TG', 'LastName': 'Burns', 'Affiliation': ""Department of Neuropsychology, Children's Healthcare of Atlanta, Atlanta, GA, United States of America.""}, {'ForeName': 'Tracy A', 'Initials': 'TA', 'LastName': 'Glauser', 'Affiliation': ""Division of Neurology, Cincinnati Children's Hospital Medical Center and Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, OH, United States of America.""}, {'ForeName': 'Becky', 'Initials': 'B', 'LastName': 'Kinkead', 'Affiliation': 'Department of Psychiatry and Behavioral Science, Emory University, Atlanta, GA, United States of America.'}, {'ForeName': 'Avital', 'Initials': 'A', 'LastName': 'Cnaan', 'Affiliation': 'Department of Pediatrics, George Washington University, Washington, DC, United States of America.'}]",Epilepsy & behavior : E&B,['10.1016/j.yebeh.2019.106687'] 3021,31610100,Comparing the Pharmacokinetics of 2 Novel Intravenous Tramadol Dosing Regimens to Oral Tramadol: A Randomized 3-Arm Crossover Study.,"Tramadol is a dual-mechanism (opiate and monoamine reuptake inhibition) analgesic. Intravenous (IV) tramadol has been widely prescribed outside the United States. However, there have not been studies comparing the pharmacokinetics (PK) of IV dosing regimens to that of oral tramadol. In this phase 1, open-label, single investigational center, 3-treatment, 3-period, multidose crossover study, we compared 2 novel IV dosing regimens (IV tramadol 75 mg and IV tramadol 50 mg) to oral tramadol 100 mg given every 6 hours (the highest approved oral dosage in the United States) Compared to the oral regimen, IV tramadol 50 mg administered at hours 0, 2, and 4 and every 4 hours thereafter reached initial tramadol peak serum concentration (C max ) more rapidly, while resulting in similar overall steady-state C max and area under the plasma concentration-time curve. IV tramadol 75 mg administered at hours 0, 3, and 6 and every 6 hours thereafter had higher C max and greater fluctuation in peak to trough tramadol concentration. The primary metabolite M1 (a potent μ agonist) had lower area under the plasma concentration-time curve and C max for both IV regimens than for the oral regimen. IV tramadol at both doses was well tolerated, with adverse event profiles consistent with the known pharmacological effects of tramadol. IV tramadol 50 mg is now in phase 3 development in patients with postsurgical pain.",2020,The primary metabolite M1 (a potent µ agonist) had lower area under the plasma concentration-time curve and C max for both IV regimens than for the oral regimen.,['patients with postsurgical pain'],"['tramadol', 'Intravenous (IV) tramadol', 'IV tramadol', 'Tramadol', 'tramadol 75\xa0mg and IV tramadol 50\xa0mg) to oral tramadol']",[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]","[{'cui': 'C0040610', 'cui_str': 'Tramadol'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}]",[],,0.0214376,The primary metabolite M1 (a potent µ agonist) had lower area under the plasma concentration-time curve and C max for both IV regimens than for the oral regimen.,"[{'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Lu', 'Affiliation': 'Avenue Therapeutics, Inc., New York, New York, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Ryan', 'Affiliation': 'Avenue Therapeutics, Inc., New York, New York, USA.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Harnett', 'Affiliation': 'Avenue Therapeutics, Inc., New York, New York, USA.'}, {'ForeName': 'George J', 'Initials': 'GJ', 'LastName': 'Atiee', 'Affiliation': 'Worldwide Clinical Trials, San Antonio, Texas, USA.'}, {'ForeName': 'Scott A', 'Initials': 'SA', 'LastName': 'Reines', 'Affiliation': 'Avenue Therapeutics, Inc., New York, New York, USA.'}]",Clinical pharmacology in drug development,['10.1002/cpdd.746'] 3022,32015723,GERI-BD: A Randomized Double-Blind Controlled Trial of Lithium and Divalproex in the Treatment of Mania in Older Patients With Bipolar Disorder.,(Reprinted with permission from Am J Psychiatry 2017; 174:1086-1093).,2019,(Reprinted with permission from Am J Psychiatry 2017; 174:1086-1093).,['Older Patients With Bipolar Disorder'],"['GERI-BD', 'Lithium and Divalproex']",[],"[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0005586', 'cui_str': 'Psychosis, Manic-Depressive'}]","[{'cui': 'C3540800', 'cui_str': 'Lithium'}, {'cui': 'C0042291', 'cui_str': 'Valproic Acid'}]",[],,0.38504,(Reprinted with permission from Am J Psychiatry 2017; 174:1086-1093).,"[{'ForeName': 'Robert C', 'Initials': 'RC', 'LastName': 'Young', 'Affiliation': ''}, {'ForeName': 'Benoit H', 'Initials': 'BH', 'LastName': 'Mulsant', 'Affiliation': ''}, {'ForeName': 'Martha', 'Initials': 'M', 'LastName': 'Sajatovic', 'Affiliation': ''}, {'ForeName': 'Ariel G', 'Initials': 'AG', 'LastName': 'Gildengers', 'Affiliation': ''}, {'ForeName': 'Laszlo', 'Initials': 'L', 'LastName': 'Gyulai', 'Affiliation': ''}, {'ForeName': 'Rayan K', 'Initials': 'RK', 'LastName': 'Al Jurdi', 'Affiliation': ''}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Beyer', 'Affiliation': ''}, {'ForeName': 'Jovier', 'Initials': 'J', 'LastName': 'Evans', 'Affiliation': ''}, {'ForeName': 'Samprit', 'Initials': 'S', 'LastName': 'Banerjee', 'Affiliation': ''}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Greenberg', 'Affiliation': ''}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Marino', 'Affiliation': ''}, {'ForeName': 'Mark E', 'Initials': 'ME', 'LastName': 'Kunik', 'Affiliation': ''}, {'ForeName': 'Peijun', 'Initials': 'P', 'LastName': 'Chen', 'Affiliation': ''}, {'ForeName': 'Marna', 'Initials': 'M', 'LastName': 'Barrett', 'Affiliation': ''}, {'ForeName': 'Herbert C', 'Initials': 'HC', 'LastName': 'Schulberg', 'Affiliation': ''}, {'ForeName': 'Martha L', 'Initials': 'ML', 'LastName': 'Bruce', 'Affiliation': ''}, {'ForeName': 'Charles F', 'Initials': 'CF', 'LastName': 'Reynolds', 'Affiliation': ''}, {'ForeName': 'George S', 'Initials': 'GS', 'LastName': 'Alexopoulos', 'Affiliation': ''}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Focus (American Psychiatric Publishing),['10.1176/appi.focus.17308'] 3023,31987974,Derivation of Dose/Volume Constraints for the Anorectum from Clinician- and Patient-Reported Outcomes in the CHHiP Trial of Radiation Therapy Fractionation.,"PURPOSE The CHHiP trial randomized 3216 men with localized prostate cancer (1:1:1) to 3 radiation therapy fractionation schedules: 74 Gy in 37 fractions over 7.4 weeks; 60 Gy in 20 fractions over 4 weeks; and 57 Gy in 19 fractions over 3.8 weeks. Literature-based dose constraints were applied with arithmetic adjustment for the hypofractionated arms. This study aimed to derive anorectal dose constraints using prospectively collected clinician-reported outcomes (CROs) and patient-reported outcomes (PROs) and to assess the added predictive value of spatial dose metrics. METHODS AND MATERIALS A case-control study design was used; 7 CRO and 5 PRO bowel symptoms were evaluated. Cases experienced a moderate or worse symptom 1 to 5 years after-radiation therapy and did not have the symptom before radiation therapy. Controls did not experience the symptom at baseline or between 1 to 5 years after radiation therapy. The anorectum was recontoured from the anal verge to the rectosigmoid junction; dose/volume parameters were extracted. Univariate logistic regression, atlases of complication indices, and bootstrapped receiver-operating-characteristic analysis (1000 replicates, balanced outcomes) were used to derive dose constraints for the whole cohort (hypofractionated schedules were converted to 2-Gy equivalent schedules using α/β = 3 Gy) and separate hypofractionated/conventional fractionation cohorts. Only areas under the curve with 95% confidence interval lower limits >0.5 were considered statistically significant. Any constraint derived in <95% to 99% of bootstraps was excluded. RESULTS Statistically significant dose constraints were derived for CROs but not PROs. Intermediate to high doses were important for rectal bleeding, whereas intermediate doses were important for increased bowel frequency, fecal incontinence, and rectal pain. Spatial dose metrics did not improve prediction of CROs or PROs. A new panel of dose constraints for hypofractionated schedules to 60 Gy or 57 Gy are V20Gy <85%, V30Gy <57%, V40Gy <38%, V50Gy <22%, and V60Gy <0.01%. CONCLUSIONS Dose constraints differed among symptoms, indicating potentially different pathogenesis of radiation-induced side effects. Derived dose constraints were stricter than those used in CHHiP and may reduce bowel symptoms after radiation therapy.",2020,"Intermediate to high doses were important for rectal bleeding whereas intermediate doses were important for increased bowel frequency, faecal incontinence and rectal pain.",['3216 men with localised prostate cancer (1:1:1'],[],"['bowel frequency, faecal incontinence and rectal pain', 'prediction of CRO or PRO']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}]",[],"[{'cui': 'C0021853', 'cui_str': 'Intestines'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0015732', 'cui_str': 'Bowel Incontinence'}, {'cui': 'C0034886', 'cui_str': 'Rectal pain (finding)'}]",3216.0,0.0516445,"Intermediate to high doses were important for rectal bleeding whereas intermediate doses were important for increased bowel frequency, faecal incontinence and rectal pain.","[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Wilkins', 'Affiliation': 'Division of Clinical Studies, Institute of Cancer Research, London, United Kingdom; The Royal Marsden Hospital, London, United Kingdom. Electronic address: anna.wilkins@icr.ac.uk.'}, {'ForeName': 'Olivia', 'Initials': 'O', 'LastName': 'Naismith', 'Affiliation': 'The Royal Marsden Hospital, London, United Kingdom; Radiotherapy Trials Quality Assurance Group, London, United Kingdom.'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Brand', 'Affiliation': 'The Royal Marsden Hospital, London, United Kingdom; Division of Radiotherapy and Imaging, Institute of Cancer Research, London, United Kingdom.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Fernandez', 'Affiliation': 'Division of Radiotherapy and Imaging, Institute of Cancer Research, London, United Kingdom.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Hall', 'Affiliation': 'Division of Clinical Studies, Institute of Cancer Research, London, United Kingdom.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Dearnaley', 'Affiliation': 'The Royal Marsden Hospital, London, United Kingdom; Division of Radiotherapy and Imaging, Institute of Cancer Research, London, United Kingdom.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Gulliford', 'Affiliation': 'Division of Radiotherapy and Imaging, Institute of Cancer Research, London, United Kingdom.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","International journal of radiation oncology, biology, physics",['10.1016/j.ijrobp.2020.01.003'] 3024,32008715,Single-Dose Oral Ibuprofen Plus Caffeine for Acute Postoperative Pain in Adults.,,2020,,['Acute Postoperative Pain in Adults'],['Ibuprofen Plus Caffeine'],[],"[{'cui': 'C2215257', 'cui_str': 'Acute postoperative pain (finding)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0020740', 'cui_str': 'Ibuprofen'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0006644', 'cui_str': 'Caffeine'}]",[],,0.0192562,,"[{'ForeName': 'Elaine', 'Initials': 'E', 'LastName': 'Musselman', 'Affiliation': 'School of Nursing, San Francisco State University, San Francisco, CA.'}, {'ForeName': 'Daphne', 'Initials': 'D', 'LastName': 'Stannard', 'Affiliation': 'School of Nursing, San Francisco State University, San Francisco, CA. Electronic address: dstannard@sfsu.edu.'}]",Journal of perianesthesia nursing : official journal of the American Society of PeriAnesthesia Nurses,['10.1016/j.jopan.2019.10.006'] 3025,32030829,A randomized trial of the acceptability of a daily multi-allergen food supplement for infants.,,2020,"This study evaluates the acceptability by parents/caregivers (parents) and tolerability by infants of a daily, single-dose, powdered food supplement containing 30 mg of protein from each of the 16 commonly allergenic foods.","['4,5', 'Infants', 'children with a food allergy']","['Daily Multi-Allergen Food Supplement', 'food allergenic protein']",[],"[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0016470', 'cui_str': 'Food Allergy'}]","[{'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C3266262', 'cui_str': 'Multi'}, {'cui': 'C0002092', 'cui_str': 'Allergens'}, {'cui': 'C0242295', 'cui_str': 'Dietary Supplementations'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}]",[],,0.253423,"This study evaluates the acceptability by parents/caregivers (parents) and tolerability by infants of a daily, single-dose, powdered food supplement containing 30 mg of protein from each of the 16 commonly allergenic foods.","[{'ForeName': 'Jane L', 'Initials': 'JL', 'LastName': 'Holl', 'Affiliation': 'Biological Sciences Division, Department of Neurology, Center for Healthcare Delivery Science and Innovation, University of Chicago, IL, USA.'}, {'ForeName': 'Lucy A', 'Initials': 'LA', 'LastName': 'Bilaver', 'Affiliation': 'Department of Pediatrics, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Finn', 'Affiliation': 'Division of Gastroenterology, Department of Medicine, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.'}, {'ForeName': 'Kay', 'Initials': 'K', 'LastName': 'Savio', 'Affiliation': 'Focus Pointe Global, Inc., St. Louis, MO, USA.'}]",Pediatric allergy and immunology : official publication of the European Society of Pediatric Allergy and Immunology,['10.1111/pai.13223'] 3026,32022470,Expectancy and Utilisation of Reflexology among Women with Advanced Breast Cancer.,"OBJECTIVE Little is understood about patient expectations and use of complementary therapies (CT) during cancer treatment. A secondary analysis of an 11-week reflexology trial among women with breast cancer was conducted. We examined factors that predicted women's expectations about reflexology for symptom relief, factors that predicted utilisation of reflexology, and whether by the end of the trial they believed that reflexology had helped with symptom management. METHODS Women (N = 256) were interviewed at baseline and week 11. Friend or family caregivers in the reflexology group were trained to deliver standardised sessions to patients at least once a week for 4 weeks. Baseline and week-11 reflexology expectations were analysed using general linear models. Reflexology utilisation was analysed with generalised linear mixed effects models. RESULTS Patients who expected benefits from reflexology (""higher expectancy"") at baseline were younger, had lower anxiety, higher education, higher spirituality, and greater CT use. Worsening symptoms over time were associated with greater utilisation of reflexology, but only when baseline expectancy was low. At week 11, expectancy was higher for those with greater symptom improvement. CONCLUSIONS Assessing patterns of patient factors, expectancy, and change in symptoms can help determine who is likely to use reflexology, and when.",2020,"RESULTS Patients who expected benefits from reflexology (""higher expectancy"") at baseline were younger, had lower anxiety, higher education, higher spirituality, and greater CT use.","['women with breast cancer', 'Women (N\xa0=\xa0256', 'Women with Advanced Breast Cancer']",[],"['Expectancy and Utilisation of Reflexology', 'Reflexology utilisation']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C3495917', 'cui_str': 'Advanced breast cancer'}]",[],"[{'cui': 'C0034945', 'cui_str': 'Reflexology'}]",256.0,0.0543432,"RESULTS Patients who expected benefits from reflexology (""higher expectancy"") at baseline were younger, had lower anxiety, higher education, higher spirituality, and greater CT use.","[{'ForeName': 'Benjamin M', 'Initials': 'BM', 'LastName': 'Rottman', 'Affiliation': 'University of Pittsburgh, Pittsburgh, PA, USA.'}, {'ForeName': 'Gwen', 'Initials': 'G', 'LastName': 'Wyatt', 'Affiliation': 'Michigan State University College of Nursing, East Lansing, MI, USA.'}, {'ForeName': 'Tracy E', 'Initials': 'TE', 'LastName': 'Crane', 'Affiliation': 'University of Arizona College of Nursing, Tucson, AZ, USA.'}, {'ForeName': 'Alla', 'Initials': 'A', 'LastName': 'Sikorskii', 'Affiliation': 'Michigan State University College of Osteopathic Medicine, East Lansing, MI, USA.'}]",Applied psychology. Health and well-being,['10.1111/aphw.12194'] 3027,32247085,"An Invited Commentary on ""comparison of the safety and efficacy of single-stage endoscopic retrograde cholangiopancreatography plus laparoscopic cholecystectomy versus two-stage ERCP followed by laparoscopic cholecystectomy six-to eight weeks later: A randomized controlled trial"" (Int J Surg 2020;76:37-44).",,2020,,[],['single-stage endoscopic retrograde cholangiopancreatography plus laparoscopic cholecystectomy versus two-stage ERCP'],[],[],"[{'cui': 'C0037179', 'cui_str': 'Single person'}, {'cui': 'C0205390', 'cui_str': 'Phase'}, {'cui': 'C0008310', 'cui_str': 'Endoscopic retrograde cholangiopancreatography'}, {'cui': 'C0332287', 'cui_str': 'With'}, {'cui': 'C0162522', 'cui_str': 'Laparoscopic cholecystectomy'}]",[],,0.137814,,"[{'ForeName': 'Maria Michela', 'Initials': 'MM', 'LastName': 'Chiarello', 'Affiliation': 'Department of Surgery, General Surgery Operative Unit, ""San Giovanni di Dio"" Hospital, Crotone, Italy. Electronic address: mikikr2001@gmail.com.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Brisinda', 'Affiliation': 'Department of Surgery, Catholic School of Medicine, ""Agostino Gemelli"" Hospital, Rome, Italy.'}]","International journal of surgery (London, England)",['10.1016/j.ijsu.2020.03.062'] 3028,32061731,Efficacy and Safety of Intensive Blood Pressure Therapy Using Restricted Mean Survival Time-Insights from the SPRINT Trial.,,2020,,[],['Intensive Blood Pressure Therapy'],[],[],"[{'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]",[],,0.0489886,,"[{'ForeName': 'Ashok', 'Initials': 'A', 'LastName': 'Krishnaswami', 'Affiliation': 'Division of Cardiology, Kaiser Permanente San Jose Medical Center, San Jose, Calif; Department of Epidemiology and Biostatistics, University of California, San Francisco. Electronic address: ashok.krishnaswami@kp.org.'}, {'ForeName': 'Eric D', 'Initials': 'ED', 'LastName': 'Peterson', 'Affiliation': 'Duke Clinical Research Institute, and Division of Cardiology, Duke University Medical Center, Durham, NC.'}, {'ForeName': 'Dae Hyun', 'Initials': 'DH', 'LastName': 'Kim', 'Affiliation': 'Hinda and Arthur Marcus Institute for Aging Research, Hebrew Senior Life, Harvard Medical School, Boston, Mass.'}, {'ForeName': 'Parag', 'Initials': 'P', 'LastName': 'Goyal', 'Affiliation': 'Department of Medicine, Weill Cornell Medicine, New York, NY.'}, {'ForeName': 'Michael W', 'Initials': 'MW', 'LastName': 'Rich', 'Affiliation': 'Division of Cardiology, Washington University, St. Louis, Mo.'}]",The American journal of medicine,['10.1016/j.amjmed.2019.12.050'] 3029,32228328,Not All Green Is Tophi: The Importance of Optimizing Minimum Attenuation and Using a Tin Filter to Minimize Clumpy Artifacts on Foot and Ankle Dual-Energy CT.,"OBJECTIVE. The clumpy artifact has a high misdiagnosis rate, but the artifact has not been well studied. The aims of this study were to evaluate the frequency and location of clumpy artifacts, the rate of misdiagnosis of clumpy artifacts as gout, and the effects of raising the minimum attenuation value and using a selective photon shield in dual-energy CT (DECT). MATERIALS AND METHODS. Forty patients without gout who underwent foot and ankle DECT were enrolled in this study. Images in both sets were randomly assigned a minimum attenuation of 130 HU or 150 HU. Three radiologists independently checked all images for presence, volume, and location of green color-coded pixelation and graded their findings according to a 4-point confidence scale, frequency, and volume. Misdiagnosis rate and misdiagnosis score were compared using the Wilcoxon signed rank and McNemar tests. RESULTS. In set 1, the frequency of clumpy artifacts in DECT with the minimum attenuation set to 130 HU and 150 HU were 81% and 68%, respectively. For all three readers, the misdiagnosis rate and misdiagnosis score decreased when changing the minimum attenuation from 130 HU to 150 HU. In set 2, with the minimum attenuation set to 130 HU, the frequency of the clumpy artifact was 44%; with the minimum attenuation set to 150 HU, no clumpy artifacts were seen. CONCLUSION. Clumpy artifacts occurred frequently in DECT without a tin filter. Setting the minimum attenuation to the higher value of 150 HU reduced the frequency of clumpy artifacts, and adding a tin filter to DECT greatly reduced their occurrence.",2020,"For all three readers, the misdiagnosis rate and misdiagnosis score decreased when changing the minimum attenuation from 130 HU to 150 HU.",['Forty patients without gout who underwent foot and ankle DECT'],['DECT'],"['Misdiagnosis rate and misdiagnosis score', 'misdiagnosis rate and misdiagnosis score', 'Clumpy artifacts']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0018099', 'cui_str': 'Gout'}, {'cui': 'C0016504', 'cui_str': 'Foot'}, {'cui': 'C0003086', 'cui_str': 'Regio tarsalis'}]",[],"[{'cui': 'C0679838', 'cui_str': 'Misdiagnosis'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0085089', 'cui_str': 'Artifacts'}]",40.0,0.0186423,"For all three readers, the misdiagnosis rate and misdiagnosis score decreased when changing the minimum attenuation from 130 HU to 150 HU.","[{'ForeName': 'Eun Hae', 'Initials': 'EH', 'LastName': 'Park', 'Affiliation': 'Department of Radiology, Chonbuk National University Medical School, Jeonju, Republic of Korea.'}, {'ForeName': 'Wan-Hee', 'Initials': 'WH', 'LastName': 'Yoo', 'Affiliation': 'Research Institute of Clinical Medicine of Chonbuk National University-Biomedical Research Institute of Chonbuk National University Hospital, Jeonju, Republic of Korea.'}, {'ForeName': 'You Seon', 'Initials': 'YS', 'LastName': 'Song', 'Affiliation': 'Department of Radiology, Pusan National University Hospital, Biomedical Research Institute, Pusan, Republic of Korea.'}, {'ForeName': 'Jung Hee', 'Initials': 'JH', 'LastName': 'Byon', 'Affiliation': 'Department of Radiology, Chonbuk National University Medical School, Jeonju, Republic of Korea.'}, {'ForeName': 'Jongjun', 'Initials': 'J', 'LastName': 'Pak', 'Affiliation': 'Siemens Healthineers Ltd., Diagnostic Imaging Korea, Seoul, Republic of Korea.'}, {'ForeName': 'Yunjung', 'Initials': 'Y', 'LastName': 'Choi', 'Affiliation': 'Research Institute of Clinical Medicine of Chonbuk National University-Biomedical Research Institute of Chonbuk National University Hospital, Jeonju, Republic of Korea.'}]",AJR. American journal of roentgenology,['10.2214/AJR.19.22222'] 3030,32194254,Commentary on 'Comparison of the safety and efficacy of single-stage endoscopic retrograde cholangiopancreatography plus laparoscopic cholecystectomy versus two-stage ERCP followed by laparoscopic cholecystectomy six-to eight weeks later: A randomized controlled trial' (Int J Surg 2020;76:37-44).,,2020,,[],['single-stage endoscopic retrograde cholangiopancreatography plus laparoscopic cholecystectomy versus two-stage ERCP'],[],[],"[{'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0008310', 'cui_str': 'ERCP'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0162522', 'cui_str': 'Cholecystectomy, Celioscopic'}]",[],,0.137515,,"[{'ForeName': 'Meer M', 'Initials': 'MM', 'LastName': 'Chisthi', 'Affiliation': 'Department of General Surgery, Government Medical College, Trivandrum, Kerala, 695011, India. Electronic address: meerchisthi@gmail.com.'}]","International journal of surgery (London, England)",['10.1016/j.ijsu.2020.03.015'] 3031,30374191,Opioid system modulation with buprenorphine/samidorphan combination for major depressive disorder: two randomized controlled studies.,"The endogenous opioid system is thought to play an important role in the regulation of mood. Buprenorphine/samidorphan (BUP/SAM) combination is an investigational opioid system modulator for adjunctive treatment of major depressive disorder (MDD). To confirm results from early studies, we report the efficacy and safety of BUP/SAM as adjunctive treatment in patients with MDD and an inadequate response to antidepressant therapy (ADT) in FORWARD-4 and FORWARD-5: two phase 3, randomized, double-blind, placebo-controlled studies that utilized the same sequential parallel-comparison design. Efficacy was measured using the Montgomery-Åsberg Depression Rating Scale (MADRS). FORWARD-5 achieved the primary endpoint and demonstrated that adjunctive BUP/SAM 2 mg/2 mg was superior to placebo (average difference change from baseline to week 3 through end of treatment [EOT] in MADRS-6 and -10 versus placebo: -1.5, P = 0.018; -1.9, P = 0.026, respectively). FORWARD-4 did not achieve the primary endpoint (change from baseline in MADRS-10 at week 5 versus placebo: -1.8, P = 0.109), although separate analyses showed significant treatment differences at other timepoints using traditional, regulatory-accepted endpoints such as reduction in MADRS-10 at EOT. The pooled analysis of the two studies demonstrated consistently greater reduction in MADRS-10 scores from baseline for BUP/SAM 2 mg/2 mg versus placebo at multiple timepoints including EOT and average change from baseline to week 3 through EOT (-1.8, P = 0.010; -1.8, P = 0.004, respectively). The overall effect size (Hedges' g) in the pooled analyses for MADRS-10 change from baseline to EOT was 0.22. Overall, BUP/SAM was generally well tolerated, with most adverse events (AEs) being mild or moderate in severity. The most common AEs, occurring in ≥5% of patients in the BUP/SAM 2 mg/2 mg treatment group, which was more frequently than the placebo group, included nausea, constipation, dizziness, vomiting, somnolence, fatigue, and sedation. There was minimal evidence of abuse, and no evidence of dependence or opioid withdrawal by AEs or objective measures. This report describes adjunctive BUP/SAM 2 mg/2 mg combination, a therapy with a novel opioidergic mechanism of action, as a potential new treatment option for patients with MDD who have an inadequate response to currently available ADT.",2020,,['major depressive disorder'],['buprenorphine/samidorphan combination'],[],"[{'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}]","[{'cui': 'C0006405', 'cui_str': 'Buprenorphine'}, {'cui': 'C4277369', 'cui_str': '3-carboxamido-4-hydroxynaltrexone'}]",[],,0.231079,,"[{'ForeName': 'Maurizio', 'Initials': 'M', 'LastName': 'Fava', 'Affiliation': 'Massachusetts General Hospital Clinical Trials Network and Institute (CTNI), Harvard Medical School, Boston, MA, USA. MFAVA@mgh.harvard.edu.'}, {'ForeName': 'Michael E', 'Initials': 'ME', 'LastName': 'Thase', 'Affiliation': 'University of Pennsylvania Perelman School of Medicine and the Corporal Michael Crescenz Veterans Affairs Medical Center, Philadelphia, PA, USA.'}, {'ForeName': 'Madhukar H', 'Initials': 'MH', 'LastName': 'Trivedi', 'Affiliation': 'University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Elliot', 'Initials': 'E', 'LastName': 'Ehrich', 'Affiliation': 'Alkermes, Inc., Waltham, MA, USA.'}, {'ForeName': 'William F', 'Initials': 'WF', 'LastName': 'Martin', 'Affiliation': 'Alkermes, Inc., Waltham, MA, USA.'}, {'ForeName': 'Asli', 'Initials': 'A', 'LastName': 'Memisoglu', 'Affiliation': 'Alkermes, Inc., Waltham, MA, USA.'}, {'ForeName': 'Narinder', 'Initials': 'N', 'LastName': 'Nangia', 'Affiliation': 'Alkermes, Inc., Waltham, MA, USA.'}, {'ForeName': 'Arielle D', 'Initials': 'AD', 'LastName': 'Stanford', 'Affiliation': 'Alkermes, Inc., Waltham, MA, USA.'}, {'ForeName': 'Miao', 'Initials': 'M', 'LastName': 'Yu', 'Affiliation': 'Alkermes, Inc., Waltham, MA, USA.'}, {'ForeName': 'Sanjeev', 'Initials': 'S', 'LastName': 'Pathak', 'Affiliation': 'Alkermes, Inc., Waltham, MA, USA.'}]",Molecular psychiatry,['10.1038/s41380-018-0284-1'] 3032,32026592,The effect of dapagliflozin on apolipoprotein B and glucose fluxes in patients with type 2 diabetes and well-controlled plasma LDL cholesterol.,"AIM To dissect the effects of the sodium-glucose linked transporter 2 inhibitor dapagliflozin on lipid metabolism and assess whether these effects could potentially offset cardiovascular benefit with this drug-class. MATERIALS AND METHODS We assessed the effect of dapagliflozin on lipid metabolism in 11 adults with uncomplicated type 2 diabetes. After 4 weeks of statin wash-out and 4 weeks of rosuvastatin 10 mg treatment, participants were treated with dapagliflozin 10 mg once-daily for 5 weeks. Before and after dapagliflozin, plasma lipids were measured and very low-density lipoprotein (VLDL)-1 and VLDL-2 apolipoprotein (Apo)B fluxes were assessed using (5.5.5- 2 H 3 )-leucine tracer infusion. In addition, hepatic and peripheral insulin sensitivity as well as insulin-mediated inhibition of peripheral lipolysis were measured during a two-step hyperinsulinemic-euglycaemic clamp using (6,6- 2 H 2 )-glucose and (1,1,2,3,3- 2 H 5 )-glycerol tracers. RESULTS Rosuvastatin decreased all plasma lipids significantly: total cholesterol from 4.5 (3.2-6.2) to 3.1 (2.5-3.8) mmol/L, LDL cholesterol from 2.6 (1.7-3.4) to 1.5 (1.1-2.2) mmol/L, HDL cholesterol from 1.34 (0.80-2.02) to 1.19 (0.74-1.89) mmol/L and triglycerides from 0.92 (0.31-3.91) to 0.79 (0.32-2.10) mmol/L. The addition of dapaglifozin to rosuvastatin did not raise either LDL cholesterol or total cholesterol, and only increased HDL cholesterol by 0.08 (-0.03-0.13) mmol/L (P = 0.03). In line with this, dapagliflozin did not affect VLDL-1 or VLDL-2 ApoB fluxes. Fasting endogenous glucose production tended to increase by 0.9 (-3.4-3.1) μmol kg -1 min -1 (P = 0.06), but no effect on hepatic and peripheral insulin sensitivity or on peripheral lipolysis was observed. CONCLUSIONS Dapagliflozin has no effect on plasma LDL-cholesterol levels or VLDL-apoB fluxes in the context of optimal lipid-lowering treatment, which will thus not limit cardiovascular benefit when lipids are adequately controlled.",2020,"(P = 0.06), but no effect on hepatic and peripheral insulin sensitivity or on peripheral lipolysis was observed. ","['patients with type 2 diabetes and well-controlled plasma LDL cholesterol', '11 adults with uncomplicated type 2 diabetes']","['Rosuvastatin', 'dapagliflozin', 'Dapagliflozin', 'dapagliflozin 10\u2009mg once-daily for 5\u2009weeks', 'sodium-glucose linked transporter 2 inhibitor dapagliflozin', 'rosuvastatin', 'dapaglifozin to rosuvastatin']","['hepatic and peripheral insulin sensitivity or on peripheral lipolysis', 'plasma LDL-cholesterol levels', 'VLDL-1 or VLDL-2 ApoB fluxes', 'low-density lipoprotein (VLDL)-1 and VLDL-2 apolipoprotein (Apo)B fluxes', 'LDL cholesterol', 'HDL cholesterol', 'plasma lipids', 'lipid metabolism', 'hepatic and peripheral insulin sensitivity', 'LDL cholesterol or total cholesterol', 'Fasting endogenous glucose production', 'apolipoprotein B and glucose fluxes', 'plasma lipids significantly: total cholesterol']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C3853142', 'cui_str': 'Well controlled'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}]","[{'cui': 'C0965129', 'cui_str': 'rosuvastatin'}, {'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C3709918', 'cui_str': 'dapagliflozin 10 MG'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C3541959', 'cui_str': 'Sodium supplement (substance)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C3854146', 'cui_str': 'Transporter (physical object)'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0205100', 'cui_str': 'Peripheral (qualifier value)'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0023796', 'cui_str': 'Lipolysis'}, {'cui': 'C1278149', 'cui_str': 'Plasma LDL cholesterol measurement'}, {'cui': 'C0523560', 'cui_str': 'VLDL cholesterol measurement'}, {'cui': 'C0003593', 'cui_str': 'ApoB'}, {'cui': 'C0023169', 'cui_str': 'Low-Density Lipoprotein 1'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0018667', 'cui_str': 'Cholesterol, HDL2'}, {'cui': 'C1278073', 'cui_str': 'Plasma lipids'}, {'cui': 'C0598783', 'cui_str': 'Lipid Metabolism'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0205227', 'cui_str': 'Endogenous (qualifier value)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0033268'}]",11.0,0.0484871,"(P = 0.06), but no effect on hepatic and peripheral insulin sensitivity or on peripheral lipolysis was observed. ","[{'ForeName': 'Kristien E C', 'Initials': 'KEC', 'LastName': 'Bouter', 'Affiliation': 'Department of Vascular Medicine and Experimental Vascular Medicine, Amsterdam University Medical Centers, the Netherlands.'}, {'ForeName': 'Erik J M', 'Initials': 'EJM', 'LastName': 'van Bommel', 'Affiliation': 'Diabetes Center, Department of Internal Medicine, Amsterdam University Medical Centers, the Netherlands.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Jansen', 'Affiliation': 'Department of Vascular Medicine and Experimental Vascular Medicine, Amsterdam University Medical Centers, the Netherlands.'}, {'ForeName': 'Dewi', 'Initials': 'D', 'LastName': 'van Harskamp', 'Affiliation': 'Department of Clinical Chemistry, Laboratory of Endocrinology, Amsterdam University Medical Centers, the Netherlands.'}, {'ForeName': 'Henk', 'Initials': 'H', 'LastName': 'Schierbeek', 'Affiliation': 'Department of Clinical Chemistry, Laboratory of Endocrinology, Amsterdam University Medical Centers, the Netherlands.'}, {'ForeName': 'Mariëtte T', 'Initials': 'MT', 'LastName': 'Ackermans', 'Affiliation': 'Department of Clinical Chemistry, Laboratory of Endocrinology, Amsterdam University Medical Centers, the Netherlands.'}, {'ForeName': 'Mireille J', 'Initials': 'MJ', 'LastName': 'Serlie', 'Affiliation': 'Department of Endocrinology and Metabolism, Amsterdam University Medical Centers, the Netherlands.'}, {'ForeName': 'Alinda W M', 'Initials': 'AWM', 'LastName': 'Schimmel', 'Affiliation': 'Department of Vascular Medicine and Experimental Vascular Medicine, Amsterdam University Medical Centers, the Netherlands.'}, {'ForeName': 'Max', 'Initials': 'M', 'LastName': 'Nieuwdorp', 'Affiliation': 'Department of Vascular Medicine and Experimental Vascular Medicine, Amsterdam University Medical Centers, the Netherlands.'}, {'ForeName': 'Geesje M', 'Initials': 'GM', 'LastName': 'Dallinga-Thie', 'Affiliation': 'Department of Vascular Medicine and Experimental Vascular Medicine, Amsterdam University Medical Centers, the Netherlands.'}, {'ForeName': 'Daniël H', 'Initials': 'DH', 'LastName': 'van Raalte', 'Affiliation': 'Department of Vascular Medicine and Experimental Vascular Medicine, Amsterdam University Medical Centers, the Netherlands.'}]","Diabetes, obesity & metabolism",['10.1111/dom.13990'] 3033,31957638,Effects of a 12-week yoga versus a 12-week educational film intervention on symptoms of restless legs syndrome and related outcomes: an exploratory randomized controlled trial.,"STUDY OBJECTIVES To assess the effects of a yoga versus educational film (EF) program on restless legs syndrome (RLS) symptoms and related outcomes in adults with RLS. METHODS Forty-one community-dwelling, ambulatory nonpregnant adults with moderate to severe RLS were randomized to a 12-week yoga (n = 19) or EF program (n = 22). In addition to attending classes, all participants completed practice/treatment logs. Yoga group participants were asked to practice at home 30 minutes per day on nonclass days; EF participants were instructed to record any RLS treatments used on their daily logs. Core outcomes assessed pretreatment and posttreatment were RLS symptoms and symptom severity (International RLS Study Group Scale (IRLS) and RLS ordinal scale), sleep quality, mood, perceived stress, and quality of life (QOL). RESULTS Thirty adults (13 yoga, 17 EF), aged 24 to 73 (mean = 50.4 ± 2.4 years), completed the 12-week study (78% female, 80.5% white). Post-intervention, both groups showed significant improvement in RLS symptoms and severity, perceived stress, mood, and QOL-mental health (P ≤ .04). Relative to the EF group, yoga participants demonstrated significantly greater reductions in RLS symptoms and symptom severity (P ≤ .01), and greater improvements in perceived stress and mood (P ≤ .04), as well as sleep quality (P = .09); RLS symptoms decreased to minimal/mild in 77% of yoga group participants, with none scoring in the severe range by week 12, versus 24% and 12%, respectively, in EF participants. In the yoga group, IRLS and RLS severity scores declined with increasing minutes of homework practice (r = .7, P = .009 and r = .6, P = .03, respectively), suggesting a possible dose-response relationship. CONCLUSIONS Findings of this exploratory RCT suggest that yoga may be effective in reducing RLS symptoms and symptom severity, decreasing perceived stress, and improving mood and sleep in adults with RLS. CLINICAL TRIAL REGISTRATION Registry: Clinicaltrials.gov; Title: Yoga vs. Education for Restless Legs: a Feasibility Study; Identifier: NCT03570515; URL: https://clinicaltrials.gov/ct2/show/NCT03570515.",2020,"Post-intervention, both groups showed significant improvement in RLS symptoms and severity, perceived stress, mood, and QOL-mental health (P ≤ .04).","['Thirty adults (13 yoga, 17 EF), aged 24 to 73 (mean = 50.4 ± 2.4 years), completed the 12-week study (78% female, 80.5% white', 'adults with RLS', 'Forty-one community-dwelling, ambulatory nonpregnant adults with moderate to severe RLS']","['yoga versus educational film (EF) program', 'EF program', 'educational film intervention']","['RLS symptoms and symptom severity (International RLS Study Group Scale (IRLS) and RLS ordinal scale), sleep quality, mood, perceived stress, and quality of life (QOL', 'RLS symptoms and symptom severity', 'RLS symptoms', 'IRLS and RLS severity scores', 'symptoms of restless legs syndrome and related outcomes', 'perceived stress and mood', 'restless legs syndrome (RLS) symptoms', 'sleep quality', 'RLS symptoms and severity, perceived stress, mood, and QOL-mental health']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C4517631', 'cui_str': '2.4 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C4045975', 'cui_str': 'Community Dwelling'}, {'cui': 'C0439841', 'cui_str': 'Ambulatory'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}]","[{'cui': 'C1883583', 'cui_str': 'Yoga'}, {'cui': 'C4319646', 'cui_str': 'Film'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity (finding)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0034380'}, {'cui': 'C0457451', 'cui_str': 'Severity score (qualifier value)'}, {'cui': 'C0035258', 'cui_str': 'Wittmaack Ekbom Syndrome'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C3887611', 'cui_str': 'Restlessness (finding)'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}]",30.0,0.153714,"Post-intervention, both groups showed significant improvement in RLS symptoms and severity, perceived stress, mood, and QOL-mental health (P ≤ .04).","[{'ForeName': 'Kim E', 'Initials': 'KE', 'LastName': 'Innes', 'Affiliation': 'Department of Epidemiology, West Virginia University School of Public Health, Morgantown, West Virginia.'}, {'ForeName': 'Terry Kit', 'Initials': 'TK', 'LastName': 'Selfe', 'Affiliation': 'Health Science Center Libraries, University of Florida, Gainesville, Florida.'}, {'ForeName': 'Caitlin', 'Initials': 'C', 'LastName': 'Montgomery', 'Affiliation': 'Department of Epidemiology, West Virginia University School of Public Health, Morgantown, West Virginia.'}, {'ForeName': 'Nicole', 'Initials': 'N', 'LastName': 'Hollingshead', 'Affiliation': 'Department of Family Medicine, The Ohio State University College of Medicine, Columbus, Ohio.'}, {'ForeName': 'Zenzi', 'Initials': 'Z', 'LastName': 'Huysmans', 'Affiliation': 'West Virginia University College of Physical Activity and Sport Sciences, Morgantown, West Virginia.'}, {'ForeName': 'Roshini', 'Initials': 'R', 'LastName': 'Srinivasan', 'Affiliation': 'Department of Family Medicine, The Ohio State University College of Medicine, Columbus, Ohio.'}, {'ForeName': 'Sijin', 'Initials': 'S', 'LastName': 'Wen', 'Affiliation': 'Department of Biostatistics, West Virginia University School of Public Health, Morgantown, West Virginia.'}, {'ForeName': 'Madeleine J', 'Initials': 'MJ', 'LastName': 'Hausmann', 'Affiliation': 'Department of Family Medicine, The Ohio State University College of Medicine, Columbus, Ohio.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Sherman', 'Affiliation': 'Kaiser Permanente Washington Health Research Institute, Seattle, Washington.'}, {'ForeName': 'Maryanna', 'Initials': 'M', 'LastName': 'Klatt', 'Affiliation': 'Department of Family Medicine, The Ohio State University College of Medicine, Columbus, Ohio.'}]",Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine,['10.5664/jcsm.8134'] 3034,31957640,"The relationship between obesity and sleep timing behavior, television exposure, and dinnertime among elementary school-age children.","STUDY OBJECTIVES The daily lifestyle behaviors of children have been shown to be associated with obesity. There are limited studies on the association of sleep timing behavior and body mass index (BMI), specifically in elementary school-age children. This study aimed to investigate the relationship between obesity and sleep timing patterns, television exposure time, and dinnertime among elementary school-age children. METHODS Children (n = 169) aged 6 to 10 years who were residents of Alabama were recruited for this study. The questionnaires were used to determine the bedtime, wake-up time, television exposure time, and dinnertime of the participants. The participants were categorized into four groups depending on the bedtime and wake-up time behavior habits: early bed/early wake-up (EE); early bed/late wake-up (EL); late bed/early wake-up (LE); and late bed/late wake-up (LL) time. The BMI z-score, television exposure time, and dinnertime of these groups were compared. RESULTS The LL group had a significantly higher BMI z-score compared to the EE group. The higher BMI z-score in the LL group may be associated with late bedtime and not late wake-up time. Approximately 71% of children with late bedtime (8:48 pm), 75% of children who watch television for more than 1 hour, and 54% of children who have dinner after 7:00 pm have obesity. CONCLUSIONS Daily behavior habits such as late bedtime, increased television exposure, and late dinnertime are associated with obesity.",2020,The LL group had a significantly higher BMI z-score compared to the EE group.,"['Children (n = 169) aged 6 to 10 years who were residents of Alabama were recruited for this study', 'elementary school-age children']",[],"['BMI z-score, television exposure time, and dinnertime', 'higher BMI z-score', 'BMI z-score']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001895', 'cui_str': 'Alabama'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]",[],"[{'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0039461', 'cui_str': 'Television'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0585040', 'cui_str': 'Dinnertime'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]",,0.0314043,The LL group had a significantly higher BMI z-score compared to the EE group.,"[{'ForeName': 'Chandra M K', 'Initials': 'CMK', 'LastName': 'Venkatapoorna', 'Affiliation': 'Department of Nutrition, Dietetics and Hospitality Management, Auburn University, Auburn, Alabama.'}, {'ForeName': 'Priscilla', 'Initials': 'P', 'LastName': 'Ayine', 'Affiliation': 'Department of Nutrition, Dietetics and Hospitality Management, Auburn University, Auburn, Alabama.'}, {'ForeName': 'Vaithinathan', 'Initials': 'V', 'LastName': 'Selvaraju', 'Affiliation': 'Department of Nutrition, Dietetics and Hospitality Management, Auburn University, Auburn, Alabama.'}, {'ForeName': 'Emily P', 'Initials': 'EP', 'LastName': 'Parra', 'Affiliation': 'Department of Nutrition, Dietetics and Hospitality Management, Auburn University, Auburn, Alabama.'}, {'ForeName': 'Taylor', 'Initials': 'T', 'LastName': 'Koenigs', 'Affiliation': 'Department of Nutrition, Dietetics and Hospitality Management, Auburn University, Auburn, Alabama.'}, {'ForeName': 'Jeganathan Ramesh', 'Initials': 'JR', 'LastName': 'Babu', 'Affiliation': 'Department of Nutrition, Dietetics and Hospitality Management, Auburn University, Auburn, Alabama.'}, {'ForeName': 'Thangiah', 'Initials': 'T', 'LastName': 'Geetha', 'Affiliation': 'Department of Nutrition, Dietetics and Hospitality Management, Auburn University, Auburn, Alabama.'}]",Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine,['10.5664/jcsm.8080'] 3035,31916979,Front-line chemo-immunotherapy with carboplatin-paclitaxel using oregovomab indirect immunization in advanced ovarian cancer: A randomized phase II study.,"BACKGROUND This randomized phase II study tested the hypothesis that schedule dependent chemo-immunotherapy with oregovomab improves progression free survival (PFS) and overall survival (OS) in optimally resected, Stage III/IV ovarian cancer. METHODS Patients from both academic centers and private practice in the US and Italy with Stage III/IV optimally cytoreduced ovarian cancer were randomized to standard six cycle IV carboplatin-paclitaxel chemotherapy (CP) versus CP plus four immunizations with oregovomab (CPO). A translational assessment of a cellular immune response was the primary endpoint; PFS and OS were measured as secondary endpoints. FINDINGS 97 patients at thirteen centers were accrued to the protocol, 47 to CPO and 50 to CP. Technical issues led to inconsistent performance of the primary CA125 ELISPOT leading to unevaluable results. At a median follow up of 42 months, PFS and OS outcomes revealed an unexpectedly large treatment effect for CPO relative to CP alone, with median PFS of 41.8 months (95% C.I.: 21.8 - N.E.) for CPO and 12.2 months (10.4-18.6) for CP (p = 0.0027, HR 0.46, CI 0.28-0.7). For OS, the median for CPO has not yet been reached (NE) (45.2-NE) and for CP was 43.2 months (31.8-NE) (p = 0.043, HR 0.35, CI 0.16-0.74). The oregovomab treatment resulted in no change in toxicity profile from CP. INTERPRETATION The previously identified potential clinical benefit of IV CP when administered with oregovomab was further refined in this randomized phase II study. Increases of PFS and OS of statistically and clinically significant magnitude were evident in this study of a front line chemo-immunotherapy treatment of ovarian cancer.",2020,Increases of PFS and OS of statistically and clinically significant magnitude were evident in this study of a front line chemo-immunotherapy treatment of ovarian cancer.,"['advanced ovarian cancer', 'Patients from both academic centers and private practice in the US and Italy with Stage III/IV optimally cytoreduced ovarian cancer', '97 patients at thirteen centers were accrued to the protocol, 47 to CPO and 50 to CP']","['IV CP', 'Front-line chemo-immunotherapy with carboplatin-paclitaxel', 'standard six cycle IV carboplatin-paclitaxel chemotherapy (CP) versus CP plus four immunizations with oregovomab (CPO']","['toxicity profile', 'PFS and OS', 'progression free survival (PFS) and overall survival (OS']","[{'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C1140680', 'cui_str': 'Ovary Cancer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0033174', 'cui_str': 'Private Practice'}, {'cui': 'C0022277', 'cui_str': 'Italy'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3 (qualifier value)'}, {'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C4521536', 'cui_str': 'United States Military enlisted E7 (qualifier value)'}]","[{'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0021083', 'cui_str': 'Immunotherapy'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0020971', 'cui_str': 'Sensitization, Immunologic'}, {'cui': 'C0664207', 'cui_str': 'oregovomab'}, {'cui': 'C4521536', 'cui_str': 'United States Military enlisted E7 (qualifier value)'}]","[{'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",97.0,0.170682,Increases of PFS and OS of statistically and clinically significant magnitude were evident in this study of a front line chemo-immunotherapy treatment of ovarian cancer.,"[{'ForeName': 'Molly', 'Initials': 'M', 'LastName': 'Brewer', 'Affiliation': 'University of Connecticut School of Medicine, Farmington, CT, United States of America. Electronic address: mbrewer@uchc.edu.'}, {'ForeName': 'Roberto', 'Initials': 'R', 'LastName': 'Angioli', 'Affiliation': 'Campus Biomedico of Rome, Rome, Italy.'}, {'ForeName': 'Giovani', 'Initials': 'G', 'LastName': 'Scambia', 'Affiliation': 'Fondazione Policlinico Universitario A Gemelli IRCCS, Rome, Italy.'}, {'ForeName': 'Domenica', 'Initials': 'D', 'LastName': 'Lorusso', 'Affiliation': 'Fondazione Policlinico Universitario A Gemelli IRCCS, Rome, Italy; Fondazione IRCCS Istituto Nazionale Tumori, Milan, Italy.'}, {'ForeName': 'Corrado', 'Initials': 'C', 'LastName': 'Terranova', 'Affiliation': 'Campus Biomedico of Rome, Rome, Italy.'}, {'ForeName': 'Pierluigi Benedetti', 'Initials': 'PB', 'LastName': 'Panici', 'Affiliation': 'Policlinico di Roma ""Umberto I"", Rome, Italy.'}, {'ForeName': 'Francesco', 'Initials': 'F', 'LastName': 'Raspagliesi', 'Affiliation': 'Fondazione IRCCS Istituto Nazionale Tumori, Milan, Italy.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Scollo', 'Affiliation': 'Unita operative Ostetricia e Ginecologia, Dipartimento Materno Infantile Ospedale Cannizzario di Catania, Catania, Italy.'}, {'ForeName': 'Francessco', 'Initials': 'F', 'LastName': 'Plotti', 'Affiliation': 'Campus Biomedico of Rome, Rome, Italy.'}, {'ForeName': 'Gabriella', 'Initials': 'G', 'LastName': 'Ferrandina', 'Affiliation': 'Fondazione Policlinico Universitario A Gemelli IRCCS, Rome, Italy.'}, {'ForeName': 'Vanda', 'Initials': 'V', 'LastName': 'Salutari', 'Affiliation': 'Fondazione Policlinico Universitario A Gemelli IRCCS, Rome, Italy.'}, {'ForeName': 'Caterina', 'Initials': 'C', 'LastName': 'Ricci', 'Affiliation': 'Fondazione Policlinico Universitario A Gemelli IRCCS, Rome, Italy.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Braly', 'Affiliation': 'Womens Cancer Care, Covington, LA, United States of America.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Holloway', 'Affiliation': 'AdventHealth Cancer, Orlando, FL, United States of America.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Method', 'Affiliation': 'Michiana Hematology Oncology, South Bend, IN, United States of America.'}, {'ForeName': 'Madi', 'Initials': 'M', 'LastName': 'Madiyalakan', 'Affiliation': 'OncoQuest Inc., Edmonton, Alberta, Canada.'}, {'ForeName': 'Eliel', 'Initials': 'E', 'LastName': 'Bayever', 'Affiliation': 'OncoQuest Inc., Edmonton, Alberta, Canada.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Nicodemus', 'Affiliation': 'AIT Strategies, Franconia, NH, United States of America.'}]",Gynecologic oncology,['10.1016/j.ygyno.2019.12.024'] 3036,31932108,"Pazopanib and Fosbretabulin in recurrent ovarian cancer (PAZOFOS): A multi-centre, phase 1b and open-label, randomised phase 2 trial.","OBJECTIVE Vascular co-option is a resistance mechanism to anti-angiogenic agents, but combinations of anti-vascular agents may overcome this resistance. We report a phase 1b and randomised phase 2 trial to determine the safety and efficacy of pazopanib with fosbretabulin. METHODS Eligible patients had recurrent, epithelial ovarian cancer with a platinum-free interval (PFI) of 3 to 12 months. Patients were stratified according to PFI (>6 versus ≤6 months) and prior bevacizumab use. RESULTS Twelve patients were treated in the phase 1b. Commonest grade ≥ 2 adverse events (AEs) were hypertension (100%), neutropenia (50%), fatigue (50%), vomiting (50%). There was one DLT (grade 3 fatigue). The recommended phase 2 dose level was fosbretabulin 54 mg/m 2 on days 1, 8 and 15 and pazopanib 600 mg once daily (od), every 28 days, which was then compared to pazopanib 800 mg od in a randomised phase 2 trial. Twenty-one patients were randomised (1:1) in the phase 2 trial. In phase 1b and phase 2, four patients treated with pazopanib and fosbretabulin developed reversible, treatment-related cardiac AEs, leading to premature discontinuation of the study. In the phase 2 trial, the median PFS was 7.6 months (95% CI 4.1-not estimated) versus 3.7 months (95% CI 1.0-8.1) in favour of the experimental arm (HR 0.30, 95% CI 0.09-1.03, P = .06). CONCLUSIONS It remains unclear whether pazopanib with with fosbretabulin is an efficacious regimen to treat epithelial ovarian cancer. Effective cardiac risk mitigation is needed to increase the tolerability and maximize patient safety in future trials.",2020,"In the phase 2 trial, the median PFS was 7.6 months (95% CI 4.1-not estimated) versus 3.7 months (95% CI 1.0-8.1) in favour of the experimental arm (HR 0.30, 95% CI 0.09-1.03, P = .06). ","['Twelve patients were treated in the phase 1b', 'Eligible patients had recurrent, epithelial ovarian cancer with a platinum-free interval (PFI) of 3 to 12\xa0months', 'recurrent ovarian cancer (PAZOFOS']","['Pazopanib and Fosbretabulin', 'pazopanib', 'bevacizumab']","['vomiting', 'Commonest grade\xa0≥', 'safety and efficacy', 'median PFS', 'neutropenia', 'fatigue']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0677886', 'cui_str': 'Carcinoma, Ovarian Epithelial'}, {'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1140680', 'cui_str': 'Ovary Cancer'}]","[{'cui': 'C1831796', 'cui_str': 'pazopanib'}, {'cui': 'C0056154', 'cui_str': '2-methoxy-5-((z)-2-(3,4,5-trimethoxyphenyl)vinyl)phenyl dihydrogen phosphate'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}]","[{'cui': 'C0042963', 'cui_str': 'Emesis'}, {'cui': 'C0205214', 'cui_str': 'Common (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}]",,0.212871,"In the phase 2 trial, the median PFS was 7.6 months (95% CI 4.1-not estimated) versus 3.7 months (95% CI 1.0-8.1) in favour of the experimental arm (HR 0.30, 95% CI 0.09-1.03, P = .06). ","[{'ForeName': 'Robert D', 'Initials': 'RD', 'LastName': 'Morgan', 'Affiliation': 'Christie NHS Foundation Trust, Manchester, UK; Division of Cancer Sciences, Faculty of Biology, Medicine and Health, The University of Manchester, Manchester, UK.'}, {'ForeName': 'Susana', 'Initials': 'S', 'LastName': 'Banerjee', 'Affiliation': 'The Royal Marsden NHS Foundation Trust, London, UK.'}, {'ForeName': 'Marcia', 'Initials': 'M', 'LastName': 'Hall', 'Affiliation': 'Mount Vernon Cancer Centre, Northwood, Middlesex, UK.'}, {'ForeName': 'Andrew R', 'Initials': 'AR', 'LastName': 'Clamp', 'Affiliation': 'Christie NHS Foundation Trust, Manchester, UK; Division of Cancer Sciences, Faculty of Biology, Medicine and Health, The University of Manchester, Manchester, UK.'}, {'ForeName': 'Cong', 'Initials': 'C', 'LastName': 'Zhou', 'Affiliation': 'Clinical and Experimental Pharmacology Group, Cancer Research UK Manchester Institute, Manchester, UK.'}, {'ForeName': 'Jurjees', 'Initials': 'J', 'LastName': 'Hasan', 'Affiliation': 'Christie NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'Cecilia', 'Initials': 'C', 'LastName': 'Orbegoso', 'Affiliation': 'The Royal Marsden NHS Foundation Trust, London, UK.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Taylor', 'Affiliation': 'Clinical and Experimental Pharmacology Group, Cancer Research UK Manchester Institute, Manchester, UK.'}, {'ForeName': 'Jonathan', 'Initials': 'J', 'LastName': 'Tugwood', 'Affiliation': 'Clinical and Experimental Pharmacology Group, Cancer Research UK Manchester Institute, Manchester, UK.'}, {'ForeName': 'Alexander R', 'Initials': 'AR', 'LastName': 'Lyon', 'Affiliation': 'Royal Brompton and Harefield NHS Foundation Trust, London, UK; Faculty of Medicine, National Heart & Lung Institute, Imperial College London, London, UK.'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Dive', 'Affiliation': 'Clinical and Experimental Pharmacology Group, Cancer Research UK Manchester Institute, Manchester, UK.'}, {'ForeName': 'Gordon J S', 'Initials': 'GJS', 'LastName': 'Rustin', 'Affiliation': 'Mount Vernon Cancer Centre, Northwood, Middlesex, UK.'}, {'ForeName': 'Gordon C', 'Initials': 'GC', 'LastName': 'Jayson', 'Affiliation': 'Christie NHS Foundation Trust, Manchester, UK; Division of Cancer Sciences, Faculty of Biology, Medicine and Health, The University of Manchester, Manchester, UK. Electronic address: Gordon.Jayson@christie.nhs.uk.'}]",Gynecologic oncology,['10.1016/j.ygyno.2020.01.005'] 3037,31407775,The Effects of Vibration and Pressure Treatments in the Early Postoperative Period of Rhinoplasty.,"BACKGROUND The early postoperative period can be distressing for the patients undergoing rhinoplasty since edema and ecchymosis are common complications. OBJECTIVES To analyze the effects of the vibration and pressure treatments in the early postoperative period of rhinoplasty. METHODS Sixty patients, who had undergone rhinoplasty, were randomized into 3 groups: group 1 (control group, n = 20) received classic nasal casting, group 2 (n = 20) received nasal cast with an elastic bandage to hold it on the face, and group 3 (n = 20) received vibration treatment in addition to that in group 2 following the rhinoplasty. They were evaluated preoperatively and postoperatively at 3 and 7 days in a prospective study. The postoperative edema and ecchymosis were scored by 2 independent surgeons. The postoperative pain was measured using the visual analog scale, and the necessity of anti-inflammatory medication (and the dose needed) and the cast comfort was questioned. The sebaceous activity of the nose skin was examined. A preoperative and postoperative seventh day sonographic study was performed to evaluate the tissue edema objectively. RESULTS The pressure treatment decreased the edema and ecchymosis significantly compared with the control group. The vibration treatment minimized edema, ecchymosis, sebaceous activity of the nose skin, pain score, and the need for anti-inflammatory medication, and increased the cast comfort significantly compared with the other groups (P < 0.0001). CONCLUSIONS Rapid regression of edema and ecchymosis may be achieved using the vibrating nasal cast technique that may minimize patient discomfort, pain, and sebaceous activity following rhinoplasty. LEVEL OF EVIDENCE: 1 ",2020,"The vibration treatment minimized edema, ecchymosis, sebaceous activity of the nose skin, pain score, and the need for anti-inflammatory medication, and increased the cast comfort significantly compared with the other groups (p < 0.0001). ","['Sixty patients, who had undergone rhinoplasty', 'Early Postoperative Period of Rhinoplasty']","['vibration treatment', 'Vibration and Pressure Treatments', 'classic nasal casting', 'nasal cast with an elastic bandage']","['cast comfort', 'postoperative pain', 'postoperative edema and ecchymosis', 'edema, ecchymosis, sebaceous activity of the nose skin, pain score, and the need for anti-inflammatory medication', 'tissue edema objectively', 'edema and ecchymosis', 'sebaceous activity of the nose skin']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0035467', 'cui_str': 'Plastic operation on nose'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}]","[{'cui': 'C0455941', 'cui_str': 'Vibration - treatment (regime/therapy)'}, {'cui': 'C0459800', 'cui_str': 'Vibration'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439658', 'cui_str': 'Classic (qualifier value)'}, {'cui': 'C4520890', 'cui_str': 'Nasal'}, {'cui': 'C0302143', 'cui_str': 'Casts (qualifier value)'}, {'cui': 'C0336591', 'cui_str': 'Elastic bandage'}]","[{'cui': 'C0302143', 'cui_str': 'Casts (qualifier value)'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0013604', 'cui_str': 'Hydrops'}, {'cui': 'C0013491', 'cui_str': 'Ecchymosis'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0028429', 'cui_str': 'Nose'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}]",60.0,0.0139174,"The vibration treatment minimized edema, ecchymosis, sebaceous activity of the nose skin, pain score, and the need for anti-inflammatory medication, and increased the cast comfort significantly compared with the other groups (p < 0.0001). ","[{'ForeName': 'Süleyman', 'Initials': 'S', 'LastName': 'Taş', 'Affiliation': ''}]",Aesthetic surgery journal,['10.1093/asj/sjz226'] 3038,31387013,The effects of shame on subsequent reactions to a trauma analog.,"The current study examined the effects of experimentally-induced shame on subsequent reactions to a trauma analog. Participants were 88 college-aged women randomly assigned to a shame prime condition or to a control (neutral) condition. Participants then were presented with an analog trauma audiotape depicting dating violence. Participants reported intrusive thoughts relating to the trauma analog in the two days following the procedure. Negative (shame, guilt) and positive (pride, positive affect) emotions were monitored throughout the procedure. Results indicated that the shame prime successfully increased shame in the Shame condition alone. After the trauma analog, increases in shame were noted in both conditions. In contrast, guilt reduced in the Shame condition, while this emotion increased in the Control condition, contrary to hypothesis. Shame and guilt were somewhat volatile for participants in the Shame condition in the two days following the lab procedure, while individuals in the Control condition reported steadily decreasing levels of these emotions. No between-condition differences were noted in the frequency of intrusions in the two days following the laboratory procedure, contrary to hypothesis. Results are discussed in light of our current understanding of shame and its role in PTSD, with suggestions to guide future research.",2019,"Shame and guilt were somewhat volatile for participants in the Shame condition in the two days following the lab procedure, while individuals in the Control condition reported steadily decreasing levels of these emotions.","['Participants then were presented with an analog trauma audiotape depicting dating violence', 'Participants were 88 college-aged women randomly assigned to a']",['shame prime condition or to a control (neutral) condition'],"['Shame and guilt', 'shame', 'Negative (shame, guilt) and positive (pride, positive affect) emotions']","[{'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0043251', 'cui_str': 'Trauma'}, {'cui': 'C0004295', 'cui_str': 'Audiotapes'}, {'cui': 'C4046106', 'cui_str': 'Dating Violence'}, {'cui': 'C0557806', 'cui_str': 'College (environment)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}]","[{'cui': 'C0036938', 'cui_str': 'Shame'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0036938', 'cui_str': 'Shame'}, {'cui': 'C0018379', 'cui_str': 'Guilt'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}, {'cui': 'C0013987', 'cui_str': 'Emotions'}]",,0.0232906,"Shame and guilt were somewhat volatile for participants in the Shame condition in the two days following the lab procedure, while individuals in the Control condition reported steadily decreasing levels of these emotions.","[{'ForeName': 'J Gayle', 'Initials': 'JG', 'LastName': 'Beck', 'Affiliation': 'Department of Psychology, The University of Memphis, United States. Electronic address: jgbeck@memphis.edu.'}, {'ForeName': 'Thomas S', 'Initials': 'TS', 'LastName': 'Dodson', 'Affiliation': 'Department of Psychology, The University of Memphis, United States.'}, {'ForeName': 'Alison M', 'Initials': 'AM', 'LastName': 'Pickover', 'Affiliation': 'Department of Psychology, The University of Memphis, United States.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Woodward', 'Affiliation': 'Department of Psychological Sciences, Western Kentucky University, United States.'}, {'ForeName': 'Alexandra J', 'Initials': 'AJ', 'LastName': 'Lipinski', 'Affiliation': 'Department of Psychology, The University of Memphis, United States.'}, {'ForeName': 'Han N', 'Initials': 'HN', 'LastName': 'Tran', 'Affiliation': 'Department of Psychology, The University of Memphis, United States.'}]",Journal of anxiety disorders,['10.1016/j.janxdis.2019.102108'] 3039,32034969,Omega-3 fatty acid supplementation in pregnancy-baseline omega-3 status and early preterm birth: exploratory analysis of a randomised controlled trial.,"OBJECTIVE To identify a polyunsaturated fatty acid (PUFA) biomarker able to detect which women with singleton pregnancies are most likely to benefit from omega-3 supplementation to reduce their risk of early preterm birth. DESIGN Exploratory analysis of a randomised controlled trial. SETTING Six Australian hospitals. POPULATION Women with a singleton pregnancy enrolled in the ORIP trial. METHODS Using maternal capillary whole blood collected ~14 weeks' gestation, the fatty acids in total blood lipids were quantified using gas chromatography. Interaction tests examined whether baseline PUFA status modified the effect of omega-3 supplementation on birth outcomes. MAIN OUTCOME MEASURE Early preterm birth (<34 weeks' gestation). RESULTS A low total omega-3 PUFA status in early pregnancy was associated with a higher risk of early preterm birth. Among women with a total omega-3 status ≤4.1% of total fatty acids, omega-3 supplementation substantially reduced the risk of early preterm birth compared with control (0.73 versus 3.16%; relative risk = 0.23, 95% confidence interval [CI] 0.07-0.79). Conversely, women with higher total omega-3 status in early pregnancy were at lower risk of early preterm birth. Supplementing women with a baseline status above 4.9% increased early preterm birth (2.20 versus 0.97%; relative risk = 2.27, 95% CI 1.13-4.58). CONCLUSIONS Women with singleton pregnancies and low total omega-3 PUFA status early in pregnancy have an increased risk of early preterm birth and are most likely to benefit from omega-3 supplementation to reduce this risk. Women with higher total omega-3 status are at lower risk and additional omega-3 supplementation may increase their risk. TWEETABLE ABSTRACT Low total omega-3 fat status helps identify which women benefit from extra omega-3 to reduce early prematurity.",2020,"Supplementing women with a baseline status above 4.9% increased early preterm birth (2.20% vs. 0.97%; relative risk=2.27, 95% CI 1.13-4.58). ","['Pregnancy - Baseline Omega-3 Status and Early Preterm Birth', 'women with singleton pregnancies', 'Six Australian hospitals', 'Women with singleton pregnancies', 'Women with a singleton pregnancy enrolled in the ORIP trial']","['Omega-3 Fatty Acid Supplementation', 'omega-3 supplementation', 'polyunsaturated fatty acid (PUFA) biomarker']","['early preterm birth', 'fatty acids in total blood lipids', 'higher risk of early preterm birth', ""Early preterm birth (<34 weeks' gestation"", 'risk of early preterm birth']","[{'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C1719844', 'cui_str': 'Greek letter omega'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0151526', 'cui_str': 'Premature Birth'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}]","[{'cui': 'C0561929', 'cui_str': 'N-3 fatty acid supplementation (product)'}, {'cui': 'C1719844', 'cui_str': 'Greek letter omega'}, {'cui': 'C0015684', 'cui_str': 'Fatty Acids'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}]","[{'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0151526', 'cui_str': 'Premature Birth'}, {'cui': 'C0015684', 'cui_str': 'Fatty Acids'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0005768'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0332167', 'cui_str': 'High risk of (contextual qualifier) (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",,0.2712,"Supplementing women with a baseline status above 4.9% increased early preterm birth (2.20% vs. 0.97%; relative risk=2.27, 95% CI 1.13-4.58). ","[{'ForeName': 'L A', 'Initials': 'LA', 'LastName': 'Simmonds', 'Affiliation': 'SAHMRI Women and Kids, South Australian Health and Medical Research Institute, Adelaide, SA, Australia.'}, {'ForeName': 'T R', 'Initials': 'TR', 'LastName': 'Sullivan', 'Affiliation': 'SAHMRI Women and Kids, South Australian Health and Medical Research Institute, Adelaide, SA, Australia.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Skubisz', 'Affiliation': 'SAHMRI Women and Kids, South Australian Health and Medical Research Institute, Adelaide, SA, Australia.'}, {'ForeName': 'P F', 'Initials': 'PF', 'LastName': 'Middleton', 'Affiliation': 'SAHMRI Women and Kids, South Australian Health and Medical Research Institute, Adelaide, SA, Australia.'}, {'ForeName': 'K P', 'Initials': 'KP', 'LastName': 'Best', 'Affiliation': 'SAHMRI Women and Kids, South Australian Health and Medical Research Institute, Adelaide, SA, Australia.'}, {'ForeName': 'L N', 'Initials': 'LN', 'LastName': 'Yelland', 'Affiliation': 'SAHMRI Women and Kids, South Australian Health and Medical Research Institute, Adelaide, SA, Australia.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Quinlivan', 'Affiliation': 'The Institute of Health Research, University of Notre Dame, Fremantle, WA, Australia.'}, {'ForeName': 'S J', 'Initials': 'SJ', 'LastName': 'Zhou', 'Affiliation': 'The School of Agriculture, Food and Wine, The University of Adelaide, Adelaide, SA, Australia.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Liu', 'Affiliation': 'SAHMRI Women and Kids, South Australian Health and Medical Research Institute, Adelaide, SA, Australia.'}, {'ForeName': 'A J', 'Initials': 'AJ', 'LastName': 'McPhee', 'Affiliation': 'SAHMRI Women and Kids, South Australian Health and Medical Research Institute, Adelaide, SA, Australia.'}, {'ForeName': 'R A', 'Initials': 'RA', 'LastName': 'Gibson', 'Affiliation': 'SAHMRI Women and Kids, South Australian Health and Medical Research Institute, Adelaide, SA, Australia.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Makrides', 'Affiliation': 'SAHMRI Women and Kids, South Australian Health and Medical Research Institute, Adelaide, SA, Australia.'}]",BJOG : an international journal of obstetrics and gynaecology,['10.1111/1471-0528.16168'] 3040,32067249,"Pharmacokinetics, pharmacodynamics and safety of the inverse retinoic acid-related orphan receptor γ agonist AZD0284.","AIMS Retinoic acid-related orphan receptor γ (RORγ), a master regulator of T-helper 17 (Th17) cell function and differentiation, is an attractive target for treatment of Th17-driven diseases. This first-in-human study aimed to investigate the pharmacokinetics, pharmacodynamics, safety and tolerability of the inverse RORγ agonist AZD0284. METHODS We conducted a phase I, randomized, single-blind, placebo-controlled, two-part, first-in-human study with healthy subjects receiving single (4-238 mg) or multiple (12-100 mg) oral doses of AZD0284 or placebo after overnight fasting. Subjects in the one single dose cohort additionally received a single dose of AZD0284 after a high-calorie meal. AZD0284 plasma concentrations, as well as inhibition of ex vivo-stimulated interleukin (IL)-17A release in whole blood, were frequently measured after both single and multiple dosing. RESULTS Eighty-three men participated in the study. AZD0284 was absorbed rapidly into plasma after oral dosing and exhibited a terminal half-life of 13-16 hours. Both the area under the concentration-time curve (AUC) and maximum concentration (C max ) increased subproportionally with increasing dose (95% confidence intervals of slope parameter were 0.71-0.84 and 0.72-0.88 for AUC and C max , respectively). Food intake delayed the absorption of AZD0284 but did not affect the overall exposure or half-life. AZD0284 showed dose-dependent reduction of ex vivo-stimulated IL-17A release after both single and multiple doses. No significant safety concerns were identified in the study. CONCLUSIONS AZD0284 was well tolerated, rapidly and dose-dependently absorbed, and reduced stimulated IL-17A release after single and multiple dosing. The results of this study support further clinical development of AZD0284.",2020,AZD0284 showed dose-dependent reduction of ex vivo stimulated IL-17A release after both single and multiple doses.,"['healthy subjects receiving single (4 mg to 238 mg) or multiple (12 to 100 mg', 'Eighty-three men participated in the study']","['Retinoic Acid-Related Orphan Receptor γ (RORγ', 'placebo', 'oral doses of AZD0284 or placebo']","['pharmacokinetics, pharmacodynamics, safety, and tolerability', 'stimulated IL-17A release', 'reduction of ex vivo stimulated IL-17A release', 'AZD0284 plasma concentrations', 'concentration-time curve (AUC) and maximum concentration (C max ', 'Pharmacokinetics, Pharmacodynamics, and Safety']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C4517888', 'cui_str': '83'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0040845', 'cui_str': 'retinoic acid'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0242299', 'cui_str': 'Orphans'}, {'cui': 'C0597357', 'cui_str': 'Receptor (substance)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}]","[{'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1705947', 'cui_str': 'CTLA8'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}, {'cui': 'C0806909', 'cui_str': 'Max'}]",83.0,0.0857159,AZD0284 showed dose-dependent reduction of ex vivo stimulated IL-17A release after both single and multiple doses.,"[{'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Asimus', 'Affiliation': 'Clinical Pharmacology & Quantitative Pharmacology, Clinical Pharmacology & Safety Sciences, R&D, AstraZeneca Gaithersburg, MD, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Palmér', 'Affiliation': 'Clinical Pharmacology & Quantitative Pharmacology, Clinical Pharmacology & Safety Sciences, R&D, AstraZeneca Gothenburg, Sweden.'}, {'ForeName': 'Muna', 'Initials': 'M', 'LastName': 'Albayaty', 'Affiliation': 'Early Phase Clinical Unit, Parexel, London, UK.'}, {'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Forsman', 'Affiliation': 'Clinical Development, Research and Early Development, Respiratory, Inflammation and Autoimmune, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Lundin', 'Affiliation': 'Clinical Development, Research and Early Development, Respiratory, Inflammation and Autoimmune, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Marita', 'Initials': 'M', 'LastName': 'Olsson', 'Affiliation': 'Early Biostats and Statistical Innovation, Data Science and AI, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Rikard', 'Initials': 'R', 'LastName': 'Pehrson', 'Affiliation': 'Research and Early Development, Respiratory, Inflammation and Autoimmune, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Mo', 'Affiliation': 'Patient Safety, Respiratory, Inflammation and Autoimmunity, Chief Medical Office, R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Muir', 'Initials': 'M', 'LastName': 'Russell', 'Affiliation': 'Study Delivery, Early Oncology Clinical, Oncology R&D, AstraZeneca, Cambridge, UK.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Carlert', 'Affiliation': 'Early Product Development, Pharmaceutical Sciences, R&D, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Close', 'Affiliation': 'Clinical Development, Research and Early Development, Respiratory, Inflammation and Autoimmune, BioPharmaceuticals R&D, AstraZeneca, Cambridge, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Keeling', 'Affiliation': 'Research and Early Development, Respiratory, Inflammation and Autoimmune, BioPharmaceuticals R&D, AstraZeneca, Gothenburg, Sweden.'}]",British journal of clinical pharmacology,['10.1111/bcp.14253'] 3041,32122821,Intravascular ultrasound to guide left main stem intervention: a NOBLE trial substudy.,"AIMS We aimed to investigate the association between the use and findings of IVUS with clinical outcomes in the PCI arm of a randomised trial of LMS PCI. METHODS AND RESULTS The NOBLE trial randomised patients with LMS disease to treatment by PCI or CABG. Of 603 patients treated by PCI, 435 (72%) underwent post-PCI IVUS assessment, 224 of which were analysed in a core laboratory. At five years, the composite of MACCE was 18.9% if post-PCI IVUS was performed versus 25.0% if it was not performed (p=0.45, after adjustment). Overall repeat revascularisation was not reduced (10.6% vs 16.5%, p=0.11); however, LMS TLR was (5.1% vs 11.6%, p=0.01) if IVUS was used. For comparison of stent expansion, LMS MSA was split into tertiles. We found no significant difference in MACCE, death, myocardial infarction or stent thrombosis between tertiles. There was a significant difference between the lower and upper tertiles for repeat revascularisation (17.6% vs 5.2%, p=0.02) and LMS TLR (12.2% vs 0%, p=0.002). CONCLUSIONS Post-PCI IVUS assessment and adequate stent expansion are not associated with reduced MACCE; however, there is an association with reduced LMS TLR. The use of intracoronary imaging to prevent stent underexpansion in LMS PCI is likely to improve outcomes.",2020,"Overall repeat revascularization was not reduced (10.6% vs. 16.5%, p=0.11), however LMS TLR was (5.1% vs. 11.6%, p=0.01) if IVUS was used.","['patients with LMS disease to treatment by PCI or CABG', '603 patients treated by PCI, 435(72%) underwent post-PCI IVUS assessment of which 224 were analysed in a core-laboratory']",['Intravascular ultrasound to guide left main stem intervention'],"['composite of MACCE', 'lower and upper tertiles for repeat revascularisation', 'LMS TLR', 'MACCE, death, myocardial infarction or stent thrombosis', 'Overall repeat revascularization']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0010055', 'cui_str': 'Coronary Artery Bypass Grafting'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0203108', 'cui_str': 'Pyelogram'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C4319560', 'cui_str': '224'}, {'cui': 'C0444669', 'cui_str': 'Core (qualifier value)'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}]","[{'cui': 'C0442123', 'cui_str': 'Intravascular (qualifier value)'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}, {'cui': 'C0205225', 'cui_str': 'Principal (qualifier value)'}, {'cui': 'C0162731', 'cui_str': 'STEM'}]","[{'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C3897493', 'cui_str': 'Stent thrombosis'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",603.0,0.254773,"Overall repeat revascularization was not reduced (10.6% vs. 16.5%, p=0.11), however LMS TLR was (5.1% vs. 11.6%, p=0.01) if IVUS was used.","[{'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Ladwiniec', 'Affiliation': 'Department of Cardiology, Glenfield Hospital, Leicester, United Kingdom.'}, {'ForeName': 'Simon J', 'Initials': 'SJ', 'LastName': 'Walsh', 'Affiliation': ''}, {'ForeName': 'Niels Ramsing', 'Initials': 'NR', 'LastName': 'Holm', 'Affiliation': ''}, {'ForeName': 'Colm G', 'Initials': 'CG', 'LastName': 'Hanratty', 'Affiliation': ''}, {'ForeName': 'Timo', 'Initials': 'T', 'LastName': 'Mäkikallio', 'Affiliation': ''}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Kellerth', 'Affiliation': ''}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Hildick-Smith', 'Affiliation': ''}, {'ForeName': 'Lone J H', 'Initials': 'LJH', 'LastName': 'Mogensen', 'Affiliation': ''}, {'ForeName': 'Juha', 'Initials': 'J', 'LastName': 'Hartikainen', 'Affiliation': ''}, {'ForeName': 'Ian B A', 'Initials': 'IBA', 'LastName': 'Menown', 'Affiliation': ''}, {'ForeName': 'Andrejs', 'Initials': 'A', 'LastName': 'Erglis', 'Affiliation': ''}, {'ForeName': 'Erlend', 'Initials': 'E', 'LastName': 'Eriksen', 'Affiliation': ''}, {'ForeName': 'Mark S', 'Initials': 'MS', 'LastName': 'Spence', 'Affiliation': ''}, {'ForeName': 'Leif', 'Initials': 'L', 'LastName': 'Thuesen', 'Affiliation': ''}, {'ForeName': 'Evald Høj', 'Initials': 'EH', 'LastName': 'Christiansen', 'Affiliation': ''}]",EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology,['10.4244/EIJ-D-19-01003'] 3042,32077134,"Effects, costs and implementation of monitoring kidney transplant patients' tacrolimus levels with dried blood spot sampling: A randomized controlled hybrid implementation trial.","AIMS Dried blood spot (DBS) home sampling allows monitoring creatinine levels and tacrolimus trough levels as an alternative for blood sampling in the hospital, which is important in kidney transplant patient follow-up. This study aims to assess whether DBS home sampling results in decreased patient travel burden and lower societal costs. METHODS In this single-centre randomized controlled hybrid implementation trial, adult kidney transplant patients were enrolled. The intervention group (n = 25) used DBS home sampling on top of usual care in the first 6 months after transplantation. The control group (n = 23) received usual care only. The primary endpoint was the number of outpatient visits. Other endpoints were costs per patient, patient satisfaction and implementation. RESULTS There was no statistically significant difference in the average number of outpatient visits between the DBS group (11.2, standard deviation: 1.7) and the control group (10.9, standard deviation: 1.4; P = .48). Average costs per visit in the DBS group were not significantly different (€542, 95% confidence interval €316-990) compared to the control group (€533, 95% confidence interval €278-1093; P = .66). Most patients (n = 19/23, 82.6%) were willing to perform DBS home-sampling if this would reduce the number of hospital visits. Only 55.9% (n = 143/256) of the expected DBS samples were received and 1/5 analysed on time (n = 52/256). CONCLUSION Adult kidney transplant patients are willing to perform DBS home sampling. However, to decrease patient travel burden and costs in post-transplant care, optimization of the logistical process concerning mailing and analysis of DBS samples is crucial.",2020,"Average costs per visit in the DBS group were not significantly different (€542, 95%CI €","['Adult kidney transplant patients', 'adult kidney transplant patients were enrolled', ""kidney transplant patients' tacrolimus levels with Dried Blood Spot sampling""]","['Dried Blood Spot (DBS', 'usual care only', 'DBS home sampling']","['average number of outpatient visits', 'costs per patient (2) patient satisfaction and (3) implementation', 'patient travel burden and lower societal costs', 'number of outpatient visits', 'Average costs per visit', 'number of hospital visits']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0022671', 'cui_str': 'Grafting, Kidney'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0085149', 'cui_str': 'Tacrolimus'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205222', 'cui_str': 'Dry (qualifier value)'}, {'cui': 'C0005768'}, {'cui': 'C0848332', 'cui_str': 'Spots on skin (disorder)'}]","[{'cui': 'C0205222', 'cui_str': 'Dry (qualifier value)'}, {'cui': 'C0005768'}, {'cui': 'C0848332', 'cui_str': 'Spots on skin (disorder)'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C0040802', 'cui_str': 'Travel (event)'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}]",,0.114818,"Average costs per visit in the DBS group were not significantly different (€542, 95%CI €","[{'ForeName': 'Herman', 'Initials': 'H', 'LastName': 'Veenhof', 'Affiliation': 'Department of Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Job Frank Martien', 'Initials': 'JFM', 'LastName': 'van Boven', 'Affiliation': 'Department of Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'van der Voort', 'Affiliation': 'Department of Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Stefan Philip', 'Initials': 'SP', 'LastName': 'Berger', 'Affiliation': 'Department of Internal Medicine, Division of Nephrology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Stephanus Johannes Leonardus', 'Initials': 'SJL', 'LastName': 'Bakker', 'Affiliation': 'Department of Internal Medicine, Division of Nephrology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Daniël Johannes', 'Initials': 'DJ', 'LastName': 'Touw', 'Affiliation': 'Department of Clinical Pharmacy and Pharmacology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.'}]",British journal of clinical pharmacology,['10.1111/bcp.14249'] 3043,30819379,Sex Differences in Outcomes and Responses to Spironolactone in Heart Failure With Preserved Ejection Fraction: A Secondary Analysis of TOPCAT Trial.,"OBJECTIVES This study sought to investigate sex differences in outcomes and responses to spironolactone in patients with heart failure with preserved ejection fraction (HFpEF). BACKGROUND HFpEF affects women more frequently than men. Sex differences in responses to effects of mineralocorticoid antagonists have not been reported. METHODS This was an exploratory, post hoc, non-pre-specified analysis of the TOPCAT (Aldosterone Antagonist Therapy for Adults With Heart Failure and Preserved Systolic Function) trial. Subjects with symptomatic HF and a left ventricular ejection fraction ≥45% were randomized to spironolactone or placebo therapy. Subjects enrolled from the Americas were analyzed. The primary outcome was a composite of cardiovascular (CV) death, cardiac arrest, or HF hospitalization. Secondary outcomes included all-cause mortality, CV, and non-CV mortality and CV, HF, and non-CV hospitalization. Sex differences in outcomes and treatment effects were determined using time-to-event analysis. RESULTS In total, 882 of 1,767 subjects (49.9%) were women. Women were older with fewer comorbidities but worse patient-reported outcomes. There were no sex differences in outcomes in the placebo arm or in response to spironolactone for the primary outcome or its components. Spironolactone therapy was associated with reduced all-cause mortality in women (hazard ratio: 0.66; p = 0.01) but not in men (p interaction  = 0.02). CONCLUSIONS In TOPCAT, women and men presented with different clinical profiles and similar clinical outcomes. The interaction between spironolactone and sex in TOPCAT overall and in the present analysis was nonsignificant for the primary outcome, but there was a reduction in all-cause mortality associated with spironolactone therapy in women, with a significant interaction between sex and treatment arm. Prospective evaluation is needed to determine whether spironolactone therapy may be effective for treatment of HFpEF in women. (Aldosterone Antagonist Therapy for Adults With Heart Failure and Preserved Systolic Function [TOPCAT]; NCT00094302).",2019,There were no sex differences in outcomes in the placebo arm or in response to spironolactone for the primary outcome or its components.,"['In total, 882 of 1,767 subjects (49.9%) were women', 'Subjects with symptomatic HF and a left ventricular ejection fraction', 'women', 'Subjects enrolled from the Americas were analyzed', 'patients with heart failure with preserved ejection fraction (HFpEF', 'Adults With Heart Failure and Preserved Systolic Function) trial', 'Adults With Heart Failure and Preserved Systolic Function [TOPCAT', 'Heart Failure']","['placebo', 'TOPCAT (Aldosterone Antagonist Therapy', 'spironolactone therapy', 'spironolactone or placebo', 'Preserved Ejection Fraction', 'Spironolactone', 'Aldosterone Antagonist Therapy', 'spironolactone']","['cause mortality', 'cause mortality, CV, and non-CV mortality and CV, HF, and non-CV hospitalization', 'composite of cardiovascular (CV) death, cardiac arrest, or HF hospitalization']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C0002454', 'cui_str': 'Americas'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0728887', 'cui_str': 'Preserving (attribute)'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0031843', 'cui_str': 'function'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0002007', 'cui_str': 'Aldosterone Antagonists'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0037982', 'cui_str': 'Spironolactone'}, {'cui': 'C0728887', 'cui_str': 'Preserving (attribute)'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}]","[{'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0018790', 'cui_str': 'Cardiac Arrest'}]",1767.0,0.321905,There were no sex differences in outcomes in the placebo arm or in response to spironolactone for the primary outcome or its components.,"[{'ForeName': 'Miranda', 'Initials': 'M', 'LastName': 'Merrill', 'Affiliation': 'Department of Internal Medicine, University of Colorado School of Medicine, Aurora, Colorado.'}, {'ForeName': 'Nancy K', 'Initials': 'NK', 'LastName': 'Sweitzer', 'Affiliation': 'Division of Cardiology, Sarver Heart Center, University of Arizona College of Medicine, Tucson, Arizona.'}, {'ForeName': 'JoAnn', 'Initials': 'J', 'LastName': 'Lindenfeld', 'Affiliation': 'Division of Cardiovascular Medicine, Vanderbilt University Medical Center, Vanderbilt Heart and Vascular Institute, Nashville, Tennessee.'}, {'ForeName': 'David P', 'Initials': 'DP', 'LastName': 'Kao', 'Affiliation': 'Division of Cardiology, University of Colorado School of Medicine, Aurora, Colorado. Electronic address: David.Kao@ucdenver.edu.'}]",JACC. Heart failure,['10.1016/j.jchf.2019.01.003'] 3044,31397587,Impact of exposure to counterstereotypic causality of obesity on beliefs about weight controllability and obesity bias.,"Individuals with obesity often report experiencing prejudice and discrimination due to their weight. Past research on obesity bias reduction strategies have yielded mixed results. The present study investigated the effectiveness of manipulating information about weight controllability in reducing obesity bias. Participants ( N = 350) were randomly assigned into one of three conditions: counterstereotypic, stereotypic, or control. Each condition consisted of four short vignettes. The counterstereotypic condition provided an uncontrollable explanation of obesity (e.g., genetics) in each vignette describing a person with obesity, while the stereotypic condition emphasized lifestyle choices as the main cause of obesity. The control condition included a vignette in which weight was not addressed. Participants completed questionnaires about weight controllability and obesity bias pre- and post-exposure. There was a significant interaction between time and condition on beliefs about weight controllability and obesity bias. Participants in the counterstereotypic condition increased in belief about the uncontrollability of weight and decreased in obesity bias, while participants in the stereotypic condition decreased in belief about the uncontrollability of weight and increased in obesity bias. Obesity bias reduction strategies that utilize information about weight controllability can be effective. However, perpetuating stereotypic causes of obesity can worsen the problem.",2020,"Participants in the counterstereotypic condition increased in belief about the uncontrollability of weight and decreased in obesity bias, while participants in the stereotypic condition decreased in belief about the uncontrollability of weight and increased in obesity bias.","['Participants ( N =\xa0350', 'Individuals with obesity often report experiencing prejudice and discrimination due to their weight']","['counterstereotypic, stereotypic, or control']","['belief about the uncontrollability of weight', 'uncontrollability of weight', 'obesity bias']","[{'cui': 'C4517735', 'cui_str': '350'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0033023', 'cui_str': 'Prejudice'}, {'cui': 'C0012632', 'cui_str': 'Discrimination'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0005346', 'cui_str': 'Bias'}]",,0.0206787,"Participants in the counterstereotypic condition increased in belief about the uncontrollability of weight and decreased in obesity bias, while participants in the stereotypic condition decreased in belief about the uncontrollability of weight and increased in obesity bias.","[{'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Lin', 'Affiliation': 'Health and Human Values Department, Davidson College , Davidson, NC, USA.'}, {'ForeName': 'Lauren A', 'Initials': 'LA', 'LastName': 'Stutts', 'Affiliation': 'Health and Human Values Department, Davidson College , Davidson, NC, USA.'}]","Psychology, health & medicine",['10.1080/13548506.2019.1653484'] 3045,31394130,"Efficacy and safety of methotrexate versus placebo as add-on therapy to H1 antihistamines for patients with difficult-to-treat chronic spontaneous urticaria: A randomized, controlled trial.",,2020,,['patients with chronic spontaneous urticaria resistant to H1-antihistamines'],"['methotrexate', 'placebo']",['Efficacy and safety'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0578870', 'cui_str': 'Chronic idiopathic urticaria (disorder)'}, {'cui': 'C0332325', 'cui_str': 'Resistant (qualifier value)'}, {'cui': 'C0019590', 'cui_str': 'Antihistamines'}]","[{'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.236275,,"[{'ForeName': 'Sophie', 'Initials': 'S', 'LastName': 'Leducq', 'Affiliation': 'Department of Dermatology, University Hospital of Tours, Tours, France; Clinical Investigation Center, INSERM CIC 1415, University Hospital of Tours, Tours, France; Université de Tours, Université de Nantes, INSERM U1246-SPHERE, France. Electronic address: soleducq@gmail.com.'}, {'ForeName': 'Mahtab', 'Initials': 'M', 'LastName': 'Samimi', 'Affiliation': 'Department of Dermatology, University Hospital of Tours, Tours, France; ISP 1282 INRA, University of Tours, Tours, France.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Bernier', 'Affiliation': 'Department of Dermatology, University Hospital Center of Nantes, Nantes, France.'}, {'ForeName': 'Angèle', 'Initials': 'A', 'LastName': 'Soria', 'Affiliation': 'Department of Dermatology and Allergology, Hospital Tenon, Paris, Assistance Publique Hopitaux de Paris, Sorbonne Université, Paris, France.'}, {'ForeName': 'Emmanuelle', 'Initials': 'E', 'LastName': 'Amsler', 'Affiliation': 'Department of Dermatology and Allergology, Hospital Tenon, Paris, Assistance Publique Hopitaux de Paris, Sorbonne Université, Paris, France.'}, {'ForeName': 'Delphine', 'Initials': 'D', 'LastName': 'Staumont-Sallé', 'Affiliation': 'CHU Lille, Service de dermatologie et vénérologie, F-59000 Lille, France, Univ. Lille, Inserm U995 - LIRIC - Lille Inflammation Research International Center, F-59000 Lille, France.'}, {'ForeName': 'Germaine', 'Initials': 'G', 'LastName': 'Gabison', 'Affiliation': 'Department of Dermatology, Assistance Publique Hôpitaux de Paris, Henri-Mondor Hospital, Créteil, France.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Chosidow', 'Affiliation': 'Department of Dermatology, Assistance Publique Hôpitaux de Paris, Henri-Mondor Hospital, Créteil, France.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Bénéton', 'Affiliation': 'Department of Dermatology, Hospital Center of le Mans, le Mans, France.'}, {'ForeName': 'Corina', 'Initials': 'C', 'LastName': 'Bara', 'Affiliation': 'Department of Dermatology, Hospital Center of le Mans, le Mans, France.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Grange-Prunier', 'Affiliation': 'Department of Dermatology, Reims University Hospital, University of Reims-Champagne-Ardenne, Reims, France.'}, {'ForeName': 'Ewa', 'Initials': 'E', 'LastName': 'Wierzbicka-Hainaut', 'Affiliation': 'Department of Dermatology, University Hospital of Poitiers, Poitiers, France.'}, {'ForeName': 'Emilie', 'Initials': 'E', 'LastName': 'Brenaut', 'Affiliation': 'Department of Dermatology, University Hospital of Brest, Brest, France.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Droitcourt', 'Affiliation': 'Department of Dermatology, University Hospital of Rennes, Rennes, France.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Raison-Peyron', 'Affiliation': 'Department of Dermatology, University Hospital of Montpellier, Montpellier, France.'}, {'ForeName': 'Hélène', 'Initials': 'H', 'LastName': 'Bourgoin', 'Affiliation': 'Department of Pharmacy, University Hospital of Tours, Tours, France.'}, {'ForeName': 'Hélène', 'Initials': 'H', 'LastName': 'Cornillier', 'Affiliation': 'Department of Dermatology, University Hospital of Tours, Tours, France.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Machet', 'Affiliation': 'Department of Dermatology, University Hospital of Tours, Tours, France.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Giraudeau', 'Affiliation': 'Clinical Investigation Center, INSERM CIC 1415, University Hospital of Tours, Tours, France; Université de Tours, Université de Nantes, INSERM U1246-SPHERE, France.'}, {'ForeName': 'Agnès', 'Initials': 'A', 'LastName': 'Caille', 'Affiliation': 'Clinical Investigation Center, INSERM CIC 1415, University Hospital of Tours, Tours, France; Université de Tours, Université de Nantes, INSERM U1246-SPHERE, France.'}, {'ForeName': 'Annabel', 'Initials': 'A', 'LastName': 'Maruani', 'Affiliation': 'Department of Dermatology, University Hospital of Tours, Tours, France; Université de Tours, Université de Nantes, INSERM U1246-SPHERE, France.'}]",Journal of the American Academy of Dermatology,['10.1016/j.jaad.2019.07.097'] 3046,31391201,Paradoxical Rise in Hypoglycemia Symptoms With Development of Hyperglycemia During High-Intensity Interval Training in Type 1 Diabetes.,"OBJECTIVE To assess the reliability of self-perception of glycemia during high-intensity interval training (HIIT) in subjects with type 1 diabetes. RESEARCH DESIGN AND METHODS This randomized crossover study included subjects who completed four fasted HIIT sessions. Subjects answered the Edinburgh Hypoglycemia Scale, estimated their blood glucose (BG), and had plasma glucose (PG) collected throughout exercise and recovery. RESULTS As PG increased throughout exercise, hypoglycemia scores increased across each category: autonomic (3.1-4.4, P < 0.05), neuroglycopenic (1.5-2.4, P < 0.05), and nonspecific (1.3-1.9, P < 0.05). Subjects' estimated BG showed a negative bias that widened as exercise progressed and peaked at -1.6 ± 3.3 mmol/L ( P < 0.001) postinsulin correction. CONCLUSIONS During HIIT, despite progressing hyperglycemia, subjects experience increased hypoglycemia symptoms and tend to underestimate their BG level.",2019,"As PG increased throughout exercise, hypoglycemia scores increased across each category: autonomic (3.1-4.4, P < 0.05), neuroglycopenic (1.5-2.4, P < 0.05), and nonspecific (1.3-1.9, P < 0.05).","['subjects with type 1 diabetes (T1D', 'subjects who completed four fasted HIIT sessions', 'Hypoglycemia Symptoms With Development of Hyperglycemia']",['glycemia during high-intensity interval training (HIIT'],"['neuroglycopenic', 'hypoglycemia symptoms', 'exercise, hypoglycemia scores', 'Edinburgh Hypoglycemia Scale, estimated their blood glucose (BG), and had plasma glucose (PG) collected throughout exercise and recovery', 'nonspecific']","[{'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1331475', 'cui_str': 'Has development (attribute)'}, {'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}]","[{'cui': 'C4277545', 'cui_str': 'High-Intensity Intermittent Exercise'}]","[{'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma (procedure)'}]",,0.0396343,"As PG increased throughout exercise, hypoglycemia scores increased across each category: autonomic (3.1-4.4, P < 0.05), neuroglycopenic (1.5-2.4, P < 0.05), and nonspecific (1.3-1.9, P < 0.05).","[{'ForeName': 'Dana', 'Initials': 'D', 'LastName': 'Potashner', 'Affiliation': 'LMC Diabetes & Endocrinology, Toronto, Ontario, Canada.'}, {'ForeName': 'Ruth E', 'Initials': 'RE', 'LastName': 'Brown', 'Affiliation': 'LMC Diabetes & Endocrinology, Toronto, Ontario, Canada.'}, {'ForeName': 'Aihua', 'Initials': 'A', 'LastName': 'Li', 'Affiliation': 'LMC Diabetes & Endocrinology, Toronto, Ontario, Canada.'}, {'ForeName': 'Michael C', 'Initials': 'MC', 'LastName': 'Riddell', 'Affiliation': 'LMC Diabetes & Endocrinology, Toronto, Ontario, Canada.'}, {'ForeName': 'Ronnie', 'Initials': 'R', 'LastName': 'Aronson', 'Affiliation': 'LMC Diabetes & Endocrinology, Toronto, Ontario, Canada ronnie.aronson@lmc.ca.'}]",Diabetes care,['10.2337/dc19-0609'] 3047,32111343,Psilocybin Induces Time-Dependent Changes in Global Functional Connectivity.,"BACKGROUND The use of psilocybin in scientific and experimental clinical contexts has triggered renewed interest in the mechanism of action of psychedelics. However, its time-dependent systems-level neurobiology remains sparsely investigated in humans. METHODS We conducted a double-blind, randomized, counterbalanced, crossover study comprising 23 healthy human participants who received placebo and 0.2 mg/kg of psilocybin orally on 2 different test days. Participants underwent magnetic resonance imaging at 3 time points between administration and peak effects: 20 minutes, 40 minutes, and 70 minutes after administration. Resting-state functional connectivity was quantified via a data-driven global brain connectivity method and compared with cortical gene expression maps. RESULTS Psilocybin reduced associative, but concurrently increased sensory, brain-wide connectivity. This pattern emerged over time from administration to peak effects. Furthermore, we showed that baseline connectivity is associated with the extent of psilocybin-induced changes in functional connectivity. Lastly, psilocybin-induced changes correlated in a time-dependent manner with spatial gene expression patterns of the 5-HT 2A (5-hydroxytryptamine 2A) and 5-HT 1A (5-hydroxytryptamine 1A) receptors. CONCLUSIONS These results suggest that the integration of functional connectivity in sensory regions and the disintegration in associative regions may underlie the psychedelic state and pinpoint the critical role of the serotonin 2A and 1A receptor systems. Furthermore, baseline connectivity may represent a predictive marker of the magnitude of changes induced by psilocybin and may therefore contribute to a personalized medicine approach within the potential framework of psychedelic treatment.",2020,"RESULTS Psilocybin reduced associative, but concurrently increased sensory, brain-wide connectivity.",['23 healthy human participants who received'],"['magnetic resonance imaging', 'placebo and 0.2 mg/kg of psilocybin', 'Psilocybin', 'psilocybin']","['sensory, brain-wide connectivity', 'Global Functional Connectivity']","[{'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C1552358', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4517436', 'cui_str': '0.2'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0033850', 'cui_str': 'Psilocybin'}]","[{'cui': 'C0445254', 'cui_str': 'Sensory (qualifier value)'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}]",23.0,0.28717,"RESULTS Psilocybin reduced associative, but concurrently increased sensory, brain-wide connectivity.","[{'ForeName': 'Katrin H', 'Initials': 'KH', 'LastName': 'Preller', 'Affiliation': 'Neuropsychopharmacology and Brain Imaging Unit, University Hospital for Psychiatry Zurich, Zurich, Switzerland; Department of Psychiatry, Yale University School of Medicine, New Haven, Connecticut. Electronic address: preller@bli.uzh.ch.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Duerler', 'Affiliation': 'Neuropsychopharmacology and Brain Imaging Unit, University Hospital for Psychiatry Zurich, Zurich, Switzerland.'}, {'ForeName': 'Joshua B', 'Initials': 'JB', 'LastName': 'Burt', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, New Haven, Connecticut; Department of Physics, Yale University, New Haven, Connecticut.'}, {'ForeName': 'Jie Lisa', 'Initials': 'JL', 'LastName': 'Ji', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Brendan', 'Initials': 'B', 'LastName': 'Adkinson', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Stämpfli', 'Affiliation': 'Department of Psychiatry, Psychotherapy and Psychosomatics, University Hospital for Psychiatry Zurich, Zurich, Switzerland.'}, {'ForeName': 'Erich', 'Initials': 'E', 'LastName': 'Seifritz', 'Affiliation': 'Department of Psychiatry, Psychotherapy and Psychosomatics, University Hospital for Psychiatry Zurich, Zurich, Switzerland.'}, {'ForeName': 'Grega', 'Initials': 'G', 'LastName': 'Repovš', 'Affiliation': 'Mind and Brain Laboratory, Department of Psychology, University of Ljubljana, Ljubljana, Slovenia.'}, {'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'Krystal', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Murray', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, New Haven, Connecticut; Department of Neuroscience, Yale University School of Medicine, New Haven, Connecticut; Department of Physics, Yale University, New Haven, Connecticut.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Anticevic', 'Affiliation': 'Department of Psychiatry, Yale University School of Medicine, New Haven, Connecticut.'}, {'ForeName': 'Franz X', 'Initials': 'FX', 'LastName': 'Vollenweider', 'Affiliation': 'Neuropsychopharmacology and Brain Imaging Unit, University Hospital for Psychiatry Zurich, Zurich, Switzerland.'}]",Biological psychiatry,['10.1016/j.biopsych.2019.12.027'] 3048,21406472,Impact of lapatinib plus trastuzumab versus single-agent lapatinib on quality of life of patients with trastuzumab-refractory HER2+ metastatic breast cancer.,"BACKGROUND Progression-free survival (PFS) was significantly longer for the lapatinib plus trastuzumab (L+T) arm than for L alone in a phase III, randomized, open-label study of women with human epidermal growth factor receptor 2 positive metastatic breast cancer who had documented progression on at least one T-containing regimen in the metastatic setting. This analysis focused on impact of treatments on health-related quality of life (HRQOL). METHODS HRQOL was assessed using the Functional Assessment of Cancer Therapy-Breast (FACT-B) questionnaire. Changes from baseline and time to deterioration were analyzed in the intent-to-treat population. RESULTS Differences between the treatment arms in adjusted mean change from baseline favored the L+T arm, ranging from 0.0 to 4.1 (FACT-B), 1.0-4.0 [Functional Assessment of Cancer Therapy-General (FACT-G)], and 0.5-2.7 (Trial Outcome Index). Most differences were not statistically significant, except for FACT-G at week 12 (delta = 4.0, P = 0.037). Similar results were found in a sensitivity analysis that included HRQOL records up to patient withdrawal from original randomized treatment. The longer time to HRQOL deterioration in the L+T arm was not statistically significant (FACT-B hazard ratio, 0.82; 95% confidence interval 0.56-1.20). CONCLUSION The addition of lapatinib to trastuzumab prolonged PFS while improving or maintaining near-term HRQOL, suggesting a meaningful clinical benefit to patients.",2011,"Most differences were not statistically significant, except for FACT-G at week 12 (delta = 4.0, P = 0.037).","['women with human epidermal growth factor receptor 2 positive metastatic breast cancer who had documented progression on at least one T-containing regimen in the metastatic setting', 'patients with trastuzumab-refractory HER2+ metastatic breast cancer']","['lapatinib plus trastuzumab versus single-agent lapatinib', 'lapatinib plus trastuzumab (L+T']","['longer time to HRQOL deterioration', 'quality of life', 'health-related quality of life (HRQOL', 'Functional Assessment of Cancer Therapy-Breast']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C3496586', 'cui_str': 'epidermal growth factor receptor 2, human'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0278488', 'cui_str': 'Breast cancer metastatic'}, {'cui': 'C1301725', 'cui_str': 'Documented'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}]","[{'cui': 'C1506770', 'cui_str': 'lapatinib'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0450442', 'cui_str': 'Agent (attribute)'}]","[{'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0034380'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0006141', 'cui_str': 'Breast'}]",,0.125505,"Most differences were not statistically significant, except for FACT-G at week 12 (delta = 4.0, P = 0.037).","[{'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Wu', 'Affiliation': 'Biometrics Department, Research Triangle Institute Health Solutions, Research Triangle Park. Electronic address: ywu@rti.org.'}, {'ForeName': 'M M', 'Initials': 'MM', 'LastName': 'Amonkar', 'Affiliation': 'Global Health Outcomes, Oncology, GlaxoSmithKline, Collegeville.'}, {'ForeName': 'B H', 'Initials': 'BH', 'LastName': 'Sherrill', 'Affiliation': 'Biometrics Department, Research Triangle Institute Health Solutions, Research Triangle Park.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': ""O'Shaughnessy"", 'Affiliation': 'Baylor Sammons Cancer Center, Texas Oncology, US Oncology, Dallas, USA.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Ellis', 'Affiliation': 'Global Health Outcomes, Oncology, GlaxoSmithKline, Collegeville.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Baselga', 'Affiliation': ""Medical Oncology Service, Vall d'Hebron University Hospital, Barcelona, Spain.""}, {'ForeName': 'K L', 'Initials': 'KL', 'LastName': 'Blackwell', 'Affiliation': 'Duke University Medical Center, Durham.'}, {'ForeName': 'H J', 'Initials': 'HJ', 'LastName': 'Burstein', 'Affiliation': 'Dana-Farber Cancer Institute, Harvard Medical School, Boston, USA.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdr014'] 3049,32112166,A Comparison of Intrathecal and Intravenous Morphine for Analgesia After Hepatectomy: A Randomized Controlled Trial.,"BACKGROUND Effective analgesia is essential for patient recovery after liver resection. This study aimed to evaluate the effects of the addition of preoperative intrathecal morphine to multimodal intravenous analgesia in patients undergoing liver resection. METHODS In this single-blind randomized controlled trial, patients undergoing liver resection were randomly assigned to the patient-controlled analgesia with (ITM-IV) or without (IV) preoperative intrathecal morphine groups. All patients received acetaminophen and dexketoprofen. The primary outcome was pain severity at rest over three postoperative days, assessed using the numerical rating scale (NRS). RESULTS The study included 36 patients (18 in each group). The mean maximum daily NRS scores over the first three postoperative days in the ITM-IV and IV groups were 1.3, 1.1, and 0.3 and 1.6, 1.1, and 0.7, respectively (p = 0.580). No differences were observed in pain severity while coughing, with corresponding scores of 2.8, 2.1, and 1.1, respectively, in the ITM-IV group and 2.3, 2.2, and 1.5, respectively, in the IV group (p = 0.963). Proportions of patients reporting clinically significant pain at rest and while coughing were 11.1% and 44.4%, respectively, in the ITM-IV group, and 16.7% and 44.4%, respectively, in the IV group (both p > 0.999). Cumulative morphine doses in the ITM-IV and IV groups were 26 mg and 17 mg, respectively (p = 0.257). Both groups also showed similar time to mobilization (p = 0.791) and solid food intake (p = 0.743), sedation grade (p = 0.584), and morbidity (p = 0.402). CONCLUSIONS Preoperative intrathecal morphine administration provides no benefits to multimodal analgesia in patients undergoing liver resection. TRIAL REGISTRATION NUMBER Clinicaltrial.gov Identifier: NCT03620916.",2020,"Both groups also showed similar time to mobilization (p = 0.791) and solid food intake (p = 0.743), sedation grade (p = 0.584), and morbidity (p = 0.402). ","['patients undergoing liver resection', 'patient recovery after liver resection', '36 patients (18 in each group']","['patient-controlled analgesia with (ITM-IV) or without (IV) preoperative intrathecal morphine', 'acetaminophen and dexketoprofen', 'morphine', 'Intrathecal and Intravenous Morphine', 'preoperative intrathecal morphine']","['pain severity while coughing', 'sedation grade', 'pain severity', 'time to mobilization', 'solid food intake', 'mean maximum daily NRS scores', 'morbidity', 'pain at rest and while coughing', 'Analgesia', 'numerical rating scale (NRS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0019144', 'cui_str': 'Hepatectomy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0078944', 'cui_str': 'Patient-Controlled Analgesia'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0000970', 'cui_str': 'Acetaminophen'}, {'cui': 'C0772505', 'cui_str': 'Dexketoprofen'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0010200', 'cui_str': 'Complaining of cough (finding)'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0300926', 'cui_str': 'mobilization'}, {'cui': 'C0453855', 'cui_str': 'Solid food (substance)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0234253', 'cui_str': 'Rest pain (finding)'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0222045'}]",36.0,0.200098,"Both groups also showed similar time to mobilization (p = 0.791) and solid food intake (p = 0.743), sedation grade (p = 0.584), and morbidity (p = 0.402). ","[{'ForeName': 'Grzegorz', 'Initials': 'G', 'LastName': 'Niewiński', 'Affiliation': 'Department of Anaesthesiology and Intensive Care, Medical University of Warsaw, Warsaw, Poland.'}, {'ForeName': 'Wojciech', 'Initials': 'W', 'LastName': 'Figiel', 'Affiliation': 'Department of General, Transplant, and Liver Surgery, Medical University of Warsaw, 1A Banacha Street, 02-097, Warsaw, Poland. w.figiel@yahoo.es.'}, {'ForeName': 'Michał', 'Initials': 'M', 'LastName': 'Grąt', 'Affiliation': 'Department of General, Transplant, and Liver Surgery, Medical University of Warsaw, 1A Banacha Street, 02-097, Warsaw, Poland.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Dec', 'Affiliation': 'Department of Anaesthesiology and Intensive Care, Medical University of Warsaw, Warsaw, Poland.'}, {'ForeName': 'Marcin', 'Initials': 'M', 'LastName': 'Morawski', 'Affiliation': 'Department of General, Transplant, and Liver Surgery, Medical University of Warsaw, 1A Banacha Street, 02-097, Warsaw, Poland.'}, {'ForeName': 'Waldemar', 'Initials': 'W', 'LastName': 'Patkowski', 'Affiliation': 'Department of General, Transplant, and Liver Surgery, Medical University of Warsaw, 1A Banacha Street, 02-097, Warsaw, Poland.'}, {'ForeName': 'Krzysztof', 'Initials': 'K', 'LastName': 'Zieniewicz', 'Affiliation': 'Department of General, Transplant, and Liver Surgery, Medical University of Warsaw, 1A Banacha Street, 02-097, Warsaw, Poland.'}]",World journal of surgery,['10.1007/s00268-020-05437-x'] 3050,30942385,Daily music listening to reduce work-related stress: a randomized controlled pilot trial.,"BACKGROUND Literature shows that music can reduce stress conditions. This pilot study investigated the effects of music listening on work-related stress and well-being in healthcare professionals. METHOD A total of 45 subjects were randomly assigned to three treatment groups: No Music, Individualized Music and Melomics-Health Listening. Music groups experienced a daily 30-min-playlist listening for 3 weeks at home. The Maugeri Stress Index-Revised (MASI-R) and the Psychological General Well-Being Index (PGWBI) were administered at baseline, after 3 weeks and after 7 weeks (follow-up). Longitudinal data were analyzed by means of a nested ANOVA model, testing the main effects of time and treatment and the interaction between them. RESULTS MASI-R scores showed a positive trend in music groups and a worsening in the control group. Only the interaction time/treatment emerged as supporting a trend toward statistical significance (P = 0.07). PGWBI showed a stability in music groups and a clear decline in controls, without significant effects. CONCLUSIONS Results from the study support the need for a larger clinical trial: it is suggested that daily music listening could be implemented to reduce work-related stress and that the effects may be related, not only to individual musical preferences and familiarity, but also to specific music structures and parameters.",2020,"RESULTS MASI-R scores showed a positive trend in music groups and a worsening in the control group.",['A total of 45 subjects'],"['No Music, Individualized Music and Melomics-Health Listening', 'Daily music listening', 'music listening']","['Maugeri Stress Index-Revised (MASI-R) and the Psychological General Well-Being Index (PGWBI', 'work-related stress', 'MASI-R scores']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}]","[{'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0004339', 'cui_str': 'Auscultation'}]","[{'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C2939150', 'cui_str': 'General wellbeing (observable entity)'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",45.0,0.136178,"RESULTS MASI-R scores showed a positive trend in music groups and a worsening in the control group.","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Raglio', 'Affiliation': 'Istituti Clinici Scientifici Maugeri IRCCS, Via Maugeri, Pavia 27100, Italy.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Bellandi', 'Affiliation': 'Fondazione Istituto Ospedaliero di Sospiro, Piazza Libertà 2, Sospiro, Cremona 26048, Italy.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Gianotti', 'Affiliation': 'Fondazione Istituto Ospedaliero di Sospiro, Piazza Libertà 2, Sospiro, Cremona 26048, Italy.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Zanacchi', 'Affiliation': 'Fondazione Istituto Ospedaliero di Sospiro, Piazza Libertà 2, Sospiro, Cremona 26048, Italy.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Gnesi', 'Affiliation': 'Section of Biostatistics and Clinical Epidemiology, Department of Public Health, Experimental and Forensic Medicine, University of Pavia, via Forlanini 2, Pavia 27100, Italy.'}, {'ForeName': 'M C', 'Initials': 'MC', 'LastName': 'Monti', 'Affiliation': 'Section of Biostatistics and Clinical Epidemiology, Department of Public Health, Experimental and Forensic Medicine, University of Pavia, via Forlanini 2, Pavia 27100, Italy.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Montomoli', 'Affiliation': 'Section of Biostatistics and Clinical Epidemiology, Department of Public Health, Experimental and Forensic Medicine, University of Pavia, via Forlanini 2, Pavia 27100, Italy.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Vico', 'Affiliation': 'ETSI Informatica, Andalucia Tech, University of Malaga, Bulevar Louis Pasteur, 35, Malaga 29000, Spain.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Imbriani', 'Affiliation': 'Istituti Clinici Scientifici Maugeri IRCCS, Via Maugeri, Pavia 27100, Italy.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Giorgi', 'Affiliation': 'Istituti Clinici Scientifici Maugeri IRCCS, Via Maugeri, Pavia 27100, Italy.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Imbriani', 'Affiliation': 'Istituti Clinici Scientifici Maugeri IRCCS, Via Maugeri, Pavia 27100, Italy.'}]","Journal of public health (Oxford, England)",['10.1093/pubmed/fdz030'] 3051,31390293,"Does an Interactive, Teleconference-Delivered, Palliative Care Lecture Series Improve Nursing Home Staff Confidence?","Background: Project ECHO™ (Extension for Community Healthcare Outcomes) is a form of online interactive teaching, which has gained international traction. This project evaluates the effectiveness of an ECHO-delivered palliative care education program for the South Dublin region of Ireland. Our aim was to measure project success by quantifying gains in staff confidence. Methods: The educational program consisted of 10 interactive sessions over a five-month period on palliative care topics ranging from pain management to advance care planning. Twenty nursing homes took part in the education program. Of these, a subgroup of six nursing homes were randomly selected for assessment. Likert scale-based questionnaires assessed staff confidence before and after each lecture and assessment was repeated at least six weeks postlecture. Five of the 10 sessions were assessed in this way. Other characteristics such as staff role and years of experience were also collected. Results: Twenty nursing homes and 353 staff participated in the education sessions. Of the 6 nursing homes chosen for assessment, an average of 42 questionnaires were returned per session ( n  = 211), representing 83% of attendees at these 6 selected nursing homes. Seventy-seven percent of questionnaires were successfully followed up for six weeks. Average confidence increased by 27% pre- to postlecture (6.4 [SD = 1.4] to 8.1 [SD = 2.1], p  < 0.005). Confidence gains persisted at six weeks; 8.1 of 10 (SD = 1.4), with no significant drop-off (-0.01/10, p  = 0.95). All staff groups (nursing vs. non-nursing) exhibited equal confidence gains (nursing gain of 27%, non-nursing gain 22%, p  = 0.16), and all confidence gains persisted at six weeks. Conclusion: This interactive, novel, training program significantly improved nursing home staff confidence in managing palliative care situations, and this confidence was sustained at least six weeks after the sessions.",2020,"This interactive, novel, training program significantly improved nursing home staff confidence in managing palliative care situations, and this confidence was sustained at least six weeks after the sessions.","['subgroup of six nursing homes', 'Twenty nursing homes and 353 staff participated in the education sessions', 'Twenty nursing homes took part in the education program', 'South Dublin region of Ireland']","['palliative care topics ranging from pain management to advance care planning', 'ECHO-delivered palliative care education program']","['Average confidence', 'confidence gains (nursing gain', 'Likert scale-based questionnaires assessed staff confidence', 'Confidence gains']","[{'cui': 'C0028688', 'cui_str': 'Nursing Homes'}, {'cui': 'C2700616', 'cui_str': 'Manpowers'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0729314', 'cui_str': 'Education provision (procedure)'}, {'cui': 'C0454777', 'cui_str': 'Dublin (geographic location)'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0022067', 'cui_str': 'Ireland, Republic of'}]","[{'cui': 'C0700049', 'cui_str': 'Palliative care'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0002766', 'cui_str': 'Pain management (procedure)'}, {'cui': 'C0600371', 'cui_str': 'Advance Health Care Planning'}, {'cui': 'C3266593', 'cui_str': 'Palliative care education'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0237529', 'cui_str': 'Self Confidence'}, {'cui': 'C0028678', 'cui_str': 'nursing care'}, {'cui': 'C0451267', 'cui_str': 'Likert scale (assessment scale)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C2700616', 'cui_str': 'Manpowers'}]",,0.0366678,"This interactive, novel, training program significantly improved nursing home staff confidence in managing palliative care situations, and this confidence was sustained at least six weeks after the sessions.","[{'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Dowling', 'Affiliation': 'Department of Age-Related Health Care, Tallaght University Hospital, Dublin, Ireland.'}, {'ForeName': 'Cathy', 'Initials': 'C', 'LastName': 'Payne', 'Affiliation': ""All-Ireland Institute of Hospice and Palliative Care, Our Lady's Hospice and Care Services, Dublin, Ireland.""}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Larkin', 'Affiliation': 'School of Nursing and Midwifery, University College Dublin, Dublin, Ireland.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Ryan', 'Affiliation': 'Department of Age-Related Health Care, Tallaght University Hospital, Dublin, Ireland.'}]",Journal of palliative medicine,['10.1089/jpm.2018.0549'] 3052,31977076,The Effect of Orally Administered Dronabinol on Optic Nerve Head Blood Flow in Healthy Subjects-A Randomized Clinical Trial.,"It has been hypothesized that besides its intraocular pressure (IOP) lowering potential, tetrahydrocannabinol (THC) may also improve ocular hemodynamics. The aim of the present study was to investigate whether single oral administration of dronabinol, a synthetic THC, alters optic nerve head blood flow (ONHBF) and its regulation in healthy subjects. The study was carried out in a randomized, placebo-controlled, double-masked, two-way crossover design in 24 healthy subjects. For each study participant, 2 study days were scheduled, on which they either received capsules containing 5 mg dronabinol or placebo. ONHBF was measured with laser Doppler flowmetry at rest and while the study participants performed isometric exercise for 6 minutes to increase mean arterial blood pressure (MAP). This was repeated 1 hour after drug intake. Ocular perfusion pressure (OPP) was calculated as 2/3MAP-IOP. Dronabinol was well tolerated and no cannabinoid-related psychoactive effects were reported. Neither administration of dronabinol nor placebo had an effect on IOP, MAP, or OPP. In contrast, dronabinol significantly increased ONHBF at rest by 9.5 ± 8.1%, whereas placebo did not show a change in ONHBF (0.3 ± 7.4% vs. baseline, P < 0.001 between study days). Dronabinol did not alter the autoregulatory response of ONHBF to isometric exercise. In conclusion, the present data indicate that low-dose dronabinol increases ONHBF in healthy subjects without affecting IOP, OPP, or inducing psychoactive side effects. In addition, dronabinol does not alter the autoregulatory response of ONHBF to an experimental increase in OPP. Further studies are needed to investigate whether this effect can also be observed in patients with glaucoma.",2020,"Neither administration of dronabinol nor placebo had an effect on IOP, MAP or OPP.","['healthy subjects', 'glaucoma patients', 'twenty-four healthy subjects']","['dronabinol', 'isometric exercise', 'Dronabinol', 'placebo', 'dronabinol nor placebo', 'dronabinol or placebo', 'dronabinol, a synthetic THC']","['autoregulatory response of ONHBF to isometric exercise', 'OPP', 'Ocular perfusion pressure (OPP', 'intraocular pressure (IOP) lowering potential, tetrahydrocannabinol (THC', 'ONHBF', 'IOP, MAP or OPP', 'autoregulatory response of ONHBF', 'tolerated and no cannabinoid-related psychoactive effects', 'mean arterial blood pressure (MAP']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C2242746', 'cui_str': 'Glaucoma (SMQ)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3715070', 'cui_str': '24 (qualifier value)'}]","[{'cui': 'C0039663', 'cui_str': 'dronabinol'}, {'cui': 'C0022206', 'cui_str': 'Exercise, Isometric'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0022206', 'cui_str': 'Exercise, Isometric'}, {'cui': 'C0911329', 'cui_str': 'OPP'}, {'cui': 'C4521296', 'cui_str': 'Ocular (intended site)'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0021888', 'cui_str': 'Ocular Tension'}, {'cui': 'C1272755', 'cui_str': 'Lowered'}, {'cui': 'C0039663', 'cui_str': 'dronabinol'}, {'cui': 'C0024779', 'cui_str': 'Map'}, {'cui': 'C0202349', 'cui_str': 'Cannabinoids measurement (procedure)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1272641', 'cui_str': 'Arterial Tension'}]",24.0,0.204918,"Neither administration of dronabinol nor placebo had an effect on IOP, MAP or OPP.","[{'ForeName': 'Nikolaus', 'Initials': 'N', 'LastName': 'Hommer', 'Affiliation': 'Department of Clinical Pharmacology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Kallab', 'Affiliation': 'Department of Clinical Pharmacology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Szegedi', 'Affiliation': 'Department of Clinical Pharmacology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Puchner', 'Affiliation': 'Department of Clinical Pharmacology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Kristina', 'Initials': 'K', 'LastName': 'Stjepanek', 'Affiliation': 'Department of Clinical Pharmacology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Bauer', 'Affiliation': 'Department of Clinical Pharmacology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'René M', 'Initials': 'RM', 'LastName': 'Werkmeister', 'Affiliation': 'Center for Medical Physics and Biomedical Engineering, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Leopold', 'Initials': 'L', 'LastName': 'Schmetterer', 'Affiliation': 'Department of Clinical Pharmacology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Marihan', 'Initials': 'M', 'LastName': 'Abensperg-Traun', 'Affiliation': 'Department of Child and Adolescent Psychiatry, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Gerhard', 'Initials': 'G', 'LastName': 'Garhöfer', 'Affiliation': 'Department of Clinical Pharmacology, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Doreen', 'Initials': 'D', 'LastName': 'Schmidl', 'Affiliation': 'Department of Clinical Pharmacology, Medical University of Vienna, Vienna, Austria.'}]",Clinical pharmacology and therapeutics,['10.1002/cpt.1797'] 3053,32075666,20-kHz alternating current stimulation: effects on motor and somatosensory thresholds.,"BACKGROUND High frequency alternating current (HFAC) stimulation have been shown to produce a peripheral nerve conduction block. Currently, all the studies applying HFAC stimulation in clinical studies, have employed frequencies below 10 kHz. The main aim of this work was to investigate the neuromodulatory effect of transcutaneous 20 kHz stimulation on somatosensory and pain thresholds, and maximal handgrip strength. METHODS A randomized, crossover, single-blinded, placebo-controlled trial was conducted following recruitment of fourteen healthy volunteers. Transcutaneous stimulation at 20 kHz and sham stimulation were applied over the ulnar and median nerves of fourteen healthy volunteers for 20 min. Maximal handgrip strength (MHS), mechanical detection threshold (MDT) and pressure pain threshold (PPT) were registered prior to, during (15 min), immediately after the end (20 min), and 10 min following stimulation. RESULTS The 20 kHz stimulation showed a lower MHS during the stimulation at the 15 min (30.1 kgs SE 2.8) and at 20 min (31.8 kgs, SE 2.8) when compared to sham stimulation (35.1 kgs, SE 3.4; p < 0.001 and 34.2 kgs, SE 3.4; p = 0.03, respectively). The 20 kHz stimulation resulted in a slight increase in MDT at 15 min (0.25 mN; 0.25-2.00) when compared to the sham stimulation (0.25 mN; 0.25-0.25; p = 0.02), and no effects were showed for PPT. CONCLUSIONS High-frequency stimulation at 20 kHz suggests a partial block of nerve activity. Studies in subjects with neurological disorders characterized by nerve hyperactivity are needed to confirm the clinical impact of this non-invasive electrical stimulation technique. TRIAL REGISTRATION NCT, NCT02837458. Registered on 12 April 2017.",2020,"Maximal handgrip strength (MHS), mechanical detection threshold (MDT) and pressure pain threshold (PPT) were registered prior to, during (15 min), immediately after the end (20 min), and 10 min following stimulation. ","['fourteen healthy volunteers', 'subjects with neurological disorders', 'fourteen healthy volunteers for 20\u2009min']","['placebo', '20-kHz alternating current stimulation', 'transcutaneous 20\u2009kHz stimulation', 'Transcutaneous stimulation at 20\u2009kHz and sham stimulation']","['Maximal handgrip strength (MHS), mechanical detection threshold (MDT) and pressure pain threshold (PPT', 'slight increase in MDT', 'lower MHS', 'somatosensory and pain thresholds, and maximal handgrip strength']","[{'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0027765', 'cui_str': 'Neurologic Disorders'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0556965', 'cui_str': 'kilohertz'}, {'cui': 'C0442830', 'cui_str': 'Alternating current (physical force)'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}]","[{'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0443254', 'cui_str': 'Mechanical (qualifier value)'}, {'cui': 'C0449864', 'cui_str': 'Threshold (property) (qualifier value)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0162703', 'cui_str': 'Pain Threshold'}, {'cui': 'C2937276', 'cui_str': 'Slight (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}]",14.0,0.177765,"Maximal handgrip strength (MHS), mechanical detection threshold (MDT) and pressure pain threshold (PPT) were registered prior to, during (15 min), immediately after the end (20 min), and 10 min following stimulation. ","[{'ForeName': 'Diego', 'Initials': 'D', 'LastName': 'Serrano-Muñoz', 'Affiliation': 'Sensorimotor Function Group, Hospital Nacional de Parapléjicos, 45071, Toledo, Spain.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Avendaño-Coy', 'Affiliation': 'Toledo Physiotherapy Research Group (GIFTO), Faculty of Physiotherapy and Nursery, Castilla La Mancha University, 45071, Toledo, Spain. juan.avendano@uclm.es.'}, {'ForeName': 'Cristina', 'Initials': 'C', 'LastName': 'Simón-Martínez', 'Affiliation': 'Department of Rehabilitation Sciences, KU Leuven - University of Leuven, 3000, Leuven, Belgium.'}, {'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Taylor', 'Affiliation': 'Sensorimotor Function Group, Hospital Nacional de Parapléjicos, 45071, Toledo, Spain.'}, {'ForeName': 'Julio', 'Initials': 'J', 'LastName': 'Gómez-Soriano', 'Affiliation': 'Toledo Physiotherapy Research Group (GIFTO), Faculty of Physiotherapy and Nursery, Castilla La Mancha University, 45071, Toledo, Spain.'}]",Journal of neuroengineering and rehabilitation,['10.1186/s12984-020-00661-x'] 3054,31357259,Aerobic Training Performed at Ventilatory Threshold Improves Psychological Outcomes in Adolescents With Obesity.,"BACKGROUND Physical activity may be as effective as some drugs for improving psychological outcomes; however, vigorous exercise may be needed for improving these outcomes in adolescents with obesity. The aim of this study is to examine the effects of low- and high-intensity training on self-esteem and symptoms of depression and anxiety in adolescents with obesity. METHODS A total of 62 pubertal adolescents with obesity (age 15 [1.5] y, body mass index 34.87 [4.22] kg/m2) were randomized into high-intensity group (HIG, n = 31) or low-intensity group (LIG, n = 31) for 24 weeks. All participants also received nutritional, psychological, and clinical counseling. Body composition and measures of depressive symptoms, anxiety, and self-esteem were assessed at baseline and after 24 weeks. RESULTS Depressive symptoms decreased significantly in both HIG (d = 1.16) and LIG (d = 0.45) (P ≤ .01). Trait anxiety decreased after 24 weeks for HIG (d = 0.81, P = .002) and LIG (d = 0.31, P = .002). No changes were observed in state anxiety or self-esteem. CONCLUSIONS Results from the present study demonstrate that 24 weeks of multidisciplinary intervention improves depression and anxiety symptoms in adolescents with obesity; however, the magnitude of changes is higher in HIG compared with LIG.",2019,"Trait anxiety decreased after 24 weeks for HIG (d = 0.81, P = .002) and LIG (d = 0.31, P = .002).","['adolescents with obesity', '62 pubertal adolescents with obesity (age 15 [1.5]\xa0y, body mass index 34.87 [4.22]\xa0kg/m2', 'Adolescents With Obesity']","['Aerobic Training Performed at Ventilatory Threshold', 'low- and high-intensity training', 'multidisciplinary intervention']","['Psychological Outcomes', 'self-esteem and symptoms of depression and anxiety', 'Trait anxiety', 'Depressive symptoms', 'depression and anxiety symptoms', 'Body composition and measures of depressive symptoms, anxiety, and self-esteem', 'state anxiety or self-esteem']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C1627769', 'cui_str': 'Pubertal'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0456689', 'cui_str': 'kg/sq. m'}]","[{'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0449864', 'cui_str': 'Threshold (property) (qualifier value)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C4081854', 'cui_str': 'High intensity'}]","[{'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0036597', 'cui_str': 'Self Esteem'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C1301808', 'cui_str': 'State'}]",62.0,0.0340544,"Trait anxiety decreased after 24 weeks for HIG (d = 0.81, P = .002) and LIG (d = 0.31, P = .002).","[{'ForeName': 'Yara', 'Initials': 'Y', 'LastName': 'Fidelix', 'Affiliation': ''}, {'ForeName': 'Mara C', 'Initials': 'MC', 'LastName': 'Lofrano-Prado', 'Affiliation': ''}, {'ForeName': 'Leonardo S', 'Initials': 'LS', 'LastName': 'Fortes', 'Affiliation': ''}, {'ForeName': 'James O', 'Initials': 'JO', 'LastName': 'Hill', 'Affiliation': ''}, {'ForeName': 'Ann E', 'Initials': 'AE', 'LastName': 'Caldwell', 'Affiliation': ''}, {'ForeName': 'João P', 'Initials': 'JP', 'LastName': 'Botero', 'Affiliation': ''}, {'ForeName': 'Wagner L', 'Initials': 'WL', 'LastName': 'do Prado', 'Affiliation': ''}]",Journal of physical activity & health,['10.1123/jpah.2018-0193'] 3055,32003150,"Efficacy and safety of dapagliflozin plus saxagliptin versus insulin glargine over 52 weeks as add-on to metformin with or without sulphonylurea in patients with type 2 diabetes: A randomized, parallel-design, open-label, Phase 3 trial.","AIM Efficacy and safety of dapagliflozin plus saxagliptin (DAPA + SAXA) were compared with insulin glargine (INS) in patients with type 2 diabetes (T2D) in a 52-week extension study. MATERIALS AND METHODS This international Phase 3 study randomized adults with T2D on metformin with/without sulphonylurea. They received DAPA + SAXA or INS for 24 weeks (short-term) with a 28-week (long-term) extension. Week 52 exploratory endpoints included adjusted mean change from baseline in glycated haemoglobin A 1c (HbA1c) and body weight, and a proportion of patients achieving optimal glycaemic response without hypoglycaemia and without requiring rescue medication. RESULTS Of the 1163 patients enrolled, 643 received treatment; 600 (DAPA + SAXA, 306; INS, 294) entered the long-term phase. At 52 weeks, HbA1c [adjusted least squares (LS) mean; 95% confidence interval (CI)] decreased more with DAPA + SAXA (-1.5% [-1.6%, -1.4%]) than with INS (-1.3% [-1.4%, -1.1%]); the LS mean difference (95% CI) was -0.25% (-0.4%, -0.1%; P = 0.009). Total body weight reduced with DAPA + SAXA [LS mean (95% CI): -1.8 kg (-2.4, -1.3)] and increased with INS [LS mean (95% CI): +2.8 kg (2.2, 3.3)]. More patients on DAPA + SAXA (17.6%) achieved HbA1c <7.0% without hypoglycaemia versus those on INS (9.1%). Rescue medication was required by 77 patients (23.8%) and 97 patients (30.4%) in the DAPA + SAXA and INS groups, respectively. CONCLUSION DAPA + SAXA treatment was non-inferior to INS in reducing HbA1c and body weight, and in achieving optimal glycaemic control without hypoglycaemia in patients with T2D 52 weeks after initiation.",2020,"Total body weight reduced with DAPA+SAXA (LS mean [95% CI]: -1.8 kg [-2.4, -1.3]) and increased with INS (LS mean [95% CI]: +2.8 kg [2.2, 3.3]).","['patients with type 2 diabetes (T2D) in this 52-week extension study', '1,163 patients enrolled, 643 received treatment; 600 (DAPA+SAXA, 306; INS, 294) entered the long-term phase', 'adults with T2D on', 'patients with type 2 diabetes']","['metformin with/without sulfonylurea received DAPA+SAXA or INS', 'DAPA+SAXA', 'dapagliflozin plus saxagliptin', 'insulin glargine (INS', 'insulin glargine', 'dapagliflozin plus saxagliptin (DAPA+SAXA', 'metformin with or without sulfonylurea']","['DAPA+SAXA', 'Rescue medication', 'Efficacy and safety', 'Total body weight', 'adjusted mean change from baseline in HbA 1c and body weight, and proportion of patients achieving optimal glycemic response without hypoglycemia and without requiring rescue medication', 'HbA 1c and body weight']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0038766', 'cui_str': 'Sulfonylurea Compounds'}, {'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1611934', 'cui_str': 'saxagliptin'}, {'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}]",1163.0,0.153635,"Total body weight reduced with DAPA+SAXA (LS mean [95% CI]: -1.8 kg [-2.4, -1.3]) and increased with INS (LS mean [95% CI]: +2.8 kg [2.2, 3.3]).","[{'ForeName': 'Tina', 'Initials': 'T', 'LastName': 'Vilsbøll', 'Affiliation': 'Steno Diabetes Center Copenhagen, Gentofte Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Ella', 'Initials': 'E', 'LastName': 'Ekholm', 'Affiliation': 'AstraZeneca, Mölndal, Sweden.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Johnsson', 'Affiliation': 'AstraZeneca, Mölndal, Sweden.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Garcia-Sanchez', 'Affiliation': 'Bristol-Myers Squibb, Lawrenceville, New, Jersey.'}, {'ForeName': 'Nalina', 'Initials': 'N', 'LastName': 'Dronamraju', 'Affiliation': 'AstraZeneca, Gaithersburg, Maryland.'}, {'ForeName': 'Serge A', 'Initials': 'SA', 'LastName': 'Jabbour', 'Affiliation': 'Thomas Jefferson University, Philadelphia, Pennsylvania.'}, {'ForeName': 'Marcus', 'Initials': 'M', 'LastName': 'Lind', 'Affiliation': 'Institute of Medicine, University of Gothenburg and Department of Medicine, NU-Hospital Group, Sweden.'}]","Diabetes, obesity & metabolism",['10.1111/dom.13981'] 3056,31798953,Does occupational therapy delay or reduce the proportion of patients that receives thumb carpometacarpal joint surgery? A multicentre randomised controlled trial.,"Objectives To evaluate whether occupational therapy, provided in the period between referral and surgical consultation, might delay or reduce the need of surgery in thumb carpometacarpal joint (CMCJ) osteoarthritis and to explore predictors for CMCJ surgery. Methods This multicentre randomised controlled trial included patients referred for surgical consultation due to CMCJ osteoarthritis. An occupational therapy group received hand osteoarthritis education, assistive devices, CMCJ orthoses and exercises. A control group received only hand osteoarthritis information. Primary outcome was the proportion of patients that had received CMCJ surgery after 2 years. We examined the primary outcome and predictors for surgery with regression models, and time to surgery with the log-rank test and cox regression analyses. Results Of 221 patients screened for eligibility, 180 were randomised. Information on the primary outcome was collected from medical records for all included patients. Surgery was performed on 22 patients (24%) that had received occupational therapy and 29 (32%) control patients (OR 0.56, 95% CI 0.26 to 1.21; p=0.14). Median time to surgery was 350 days (IQR 210-540) in the occupational therapy group and 296 days (IQR 188-428) in the control group (p=0.13). Previous non-pharmacological treatment (OR 2.72, 95% CI 1.14 to 6.50) and higher motivation for surgery (OR 1.25, 95% CI 1.09 to 1.43) were significant predictors for CMCJ surgery. Conclusions Occupational therapy showed a small non-significant tendency to delay and reduce the need for surgery in CMCJ osteoarthritis. Previous non-pharmacological treatment and higher motivation for surgery were significant predictors for surgery.",2019,"Previous non-pharmacological treatment (OR 2.72, 95% CI 1.14 to 6.50) and higher motivation for surgery (OR 1.25, 95% CI 1.09 to 1.43) were significant predictors for CMCJ surgery. ","['221 patients screened for eligibility, 180 were randomised', 'patients referred for surgical consultation due to CMCJ osteoarthritis']","['occupational therapy', 'occupational therapy group received hand osteoarthritis education, assistive devices, CMCJ orthoses and exercises']","['higher motivation for surgery', 'proportion of patients that had received CMCJ surgery', 'Median time to surgery']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0009818', 'cui_str': 'Consultation'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0029408', 'cui_str': 'Arthritis, Degenerative'}]","[{'cui': 'C1318464', 'cui_str': 'Occupational Therapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0263746', 'cui_str': 'Degenerative joint disease of hand (disorder)'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0036605', 'cui_str': 'Assistive Technology'}, {'cui': 'C0029365', 'cui_str': 'Orthose'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C4082107', 'cui_str': 'High motivation (finding)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",180.0,0.13038,"Previous non-pharmacological treatment (OR 2.72, 95% CI 1.14 to 6.50) and higher motivation for surgery (OR 1.25, 95% CI 1.09 to 1.43) were significant predictors for CMCJ surgery. ","[{'ForeName': 'Else Marit Holen', 'Initials': 'EMH', 'LastName': 'Gravås', 'Affiliation': 'National Advisory Unit on Rehabilitation in Rheumatology, Department of Rheumatology, Diakonhjemmet Hospital, Oslo, Norway.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Østerås', 'Affiliation': 'National Advisory Unit on Rehabilitation in Rheumatology, Department of Rheumatology, Diakonhjemmet Hospital, Oslo, Norway.'}, {'ForeName': 'Randi', 'Initials': 'R', 'LastName': 'Nossum', 'Affiliation': 'Department of Clinical Services, Saint Olavs Hospital University Hospital in Trondheim, Trondheim, Norway.'}, {'ForeName': 'Ruth Else Mehl', 'Initials': 'REM', 'LastName': 'Eide', 'Affiliation': 'Department of Rheumatology, Haukeland University Hospital, Bergen, Norway.'}, {'ForeName': 'Åse', 'Initials': 'Å', 'LastName': 'Klokkeide', 'Affiliation': 'Department of Rheumatology, Haugesund Sanitary Association Rheumatism Hospital, Haugesund, Norway.'}, {'ForeName': 'Karin Hoegh', 'Initials': 'KH', 'LastName': 'Matre', 'Affiliation': 'Department of Rheumatology, Haukeland University Hospital, Bergen, Norway.'}, {'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Olsen', 'Affiliation': 'Department of Rheumatology, Haugesund Sanitary Association Rheumatism Hospital, Haugesund, Norway.'}, {'ForeName': 'Oyvor', 'Initials': 'O', 'LastName': 'Andreassen', 'Affiliation': 'Patient panel, Department of Rheumatology, Diakonhjemmet Hospital, Oslo, Norway.'}, {'ForeName': 'Ida K', 'Initials': 'IK', 'LastName': 'Haugen', 'Affiliation': 'Department of Rheumatology, Diakonhjemmet Hospital, Oslo, Norway.'}, {'ForeName': 'Anne Therese', 'Initials': 'AT', 'LastName': 'Tveter', 'Affiliation': 'National Advisory Unit on Rehabilitation in Rheumatology, Department of Rheumatology, Diakonhjemmet Hospital, Oslo, Norway.'}, {'ForeName': 'Ingvild', 'Initials': 'I', 'LastName': 'Kjeken', 'Affiliation': 'National Advisory Unit on Rehabilitation in Rheumatology, Department of Rheumatology, Diakonhjemmet Hospital, Oslo, Norway.'}]",RMD open,['10.1136/rmdopen-2019-001046'] 3057,32106176,Effects of Periodized vs. Nonperiodized Resistance Training on Army-Specific Fitness and Skills Performance.,"Heilbronn, BE, Doma, K, Gormann, D, Schumann, M, and Sinclair, WH. Effects of periodized vs. nonperiodized resistance training on army-specific fitness and skills performance. J Strength Cond Res 34(3): 738-753, 2020-This study investigated the effects of periodized resistance training (PRD) and nonperiodized resistance training (NPRD) on army-specific fitness and skills performance measures. Forty-nine serving members of the Australian Army were randomly assigned to 1 of 3 training groups: PRD, NPRD, or no-resistance training (NRT). Resistance training (RT) was performed during PRD and NPRD twice a week for 9 weeks, over a 15-week period, as part of a structured strength and conditioning program. Baseline, mid- and post-testing measures included anthropometric, strength, and army-specific outcome measures. Results indicated that participants who undertook RT significantly improved in 3 repetition maximum (3RM) squat, deadlift, and floor press for both RT groups, at mid- and post-testing (p < 0.05), when compared with NRT. Significant improvements were also observed in 5-km weight load marching postintervention similarly for PRD (p < 0.05) and NPRD (p < 0.01) and simulated fire and movement for both RT groups at both time points (p < 0.01), compared with the NRT group (p > 0.05). Although little difference was observed between periodization models, the current findings suggest greater advantage in developing army-specific performances if a structured RT protocol is included in a generic physical training program compared with a NRT protocol. Therefore, a structured RT program should be considered for military personnel aiming to optimize army-specific fitness and skills performance.",2020,"Significant improvements were also observed in 5-km weight load marching postintervention similarly for PRD (p < 0.05) and NPRD (p < 0.01) and simulated fire and movement for both RT groups at both time points (p < 0.01), compared with the NRT group (p > 0.05).",['Forty-nine serving members of the Australian Army'],"['Resistance training (RT', 'periodized vs. nonperiodized resistance training', 'NRT', 'PRD, NPRD, or no-resistance training (NRT', 'Periodized vs. Nonperiodized Resistance Training', 'periodized resistance training (PRD) and nonperiodized resistance training (NPRD']","['Army-Specific Fitness and Skills Performance', 'Heilbronn, BE, Doma, K, Gormann, D, Schumann, M, and Sinclair, WH', '3 repetition maximum (3RM) squat, deadlift, and floor press', '5-km weight load marching postintervention similarly for PRD', 'anthropometric, strength, and army-specific outcome measures', 'NPRD', 'army-specific fitness and skills performance']","[{'cui': 'C0680022', 'cui_str': 'Member of (attribute)'}]","[{'cui': 'C0872279', 'cui_str': 'Strength Training'}]","[{'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0241236', 'cui_str': 'Does squat (finding)'}, {'cui': 'C0016249', 'cui_str': 'Floors'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}]",,0.0137683,"Significant improvements were also observed in 5-km weight load marching postintervention similarly for PRD (p < 0.05) and NPRD (p < 0.01) and simulated fire and movement for both RT groups at both time points (p < 0.01), compared with the NRT group (p > 0.05).","[{'ForeName': 'Brian E', 'Initials': 'BE', 'LastName': 'Heilbronn', 'Affiliation': 'College of Healthcare Sciences, James Cook University, Townsville, Australia.'}, {'ForeName': 'Kenji', 'Initials': 'K', 'LastName': 'Doma', 'Affiliation': 'College of Healthcare Sciences, James Cook University, Townsville, Australia.'}, {'ForeName': 'Dale', 'Initials': 'D', 'LastName': 'Gormann', 'Affiliation': 'Australian Army, Australia.'}, {'ForeName': 'Moritz', 'Initials': 'M', 'LastName': 'Schumann', 'Affiliation': 'Institute of Cardiology and Sports Medicine, German Sport University, Cologne, Germany.'}, {'ForeName': 'Wade H', 'Initials': 'WH', 'LastName': 'Sinclair', 'Affiliation': 'College of Healthcare Sciences, James Cook University, Townsville, Australia.'}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000003029'] 3058,32091613,Effect of intrathecal morphine before and after laminectomy on intra-operative surgical stress response and post-operative pain: A prospective randomized study.,"STUDY OBJECTIVE Intrathecal administration of morphine. DESIGN A prospective, randomized, controlled study. SETTING Operating room. PATIENTS Ninety patients of American Society of Anesthesiologists physical statuses I and II undergoing lumbar laminectomy. INTERVENTIONS Pre-emptive versus post-operative intrathecal morphine injection, compared to a control group. MAIN OUTCOME The visual analog score at the time of discharge and 2, 4, 6, 8, 10, 12, 18, and 24 h later, serum cortisol level, the number of patients needing post-operative rescue analgesia, its duration, and the total amount required. MAIN RESULTS Morphine sulfate consumption as rescue analgesia over 24-h post-operatively was significantly higher in general anesthesia group (Group I) than in pre-emptive intrathecal morphine groups (Group II) [p = 0.001] and then post-operative intrathecal morphine group (Group III) [p = 0.001], and it was higher in Group III than Group II [p = 0.001]. There was a greater need for post-operative rescue morphine in general anesthesia group (Group I) than in the other two groups, and it was greater in post-operative intrathecal morphine group (Group III) than in pre-emptive in-trathecal morphine group (Group II). At 30 min after surgical incisions and at 1 and 24 h after surgery, serum cortisol levels were significantly higher in general anesthesia group (Group I) [p = 0.001] and in post-operative intrathecal mor-phine group (Group III) [p = 0.001] than in pre-emptive intrathecal morphine groups (Group II), with no significant differ-ence between general anesthesia group (Group I) and post-operative intrathecal morphine group (Group III) [p = 0.704, 0.263, and 0.943, respectively]. CONCLUSION Pre-emptive intrathecal morphine analgesia is an effective technique for controlling surgical stress re-sponse and post-lumbar laminectomy pain.",2019,"There was a greater need for post-operative rescue morphine in general anesthesia group (Group I) than in the other two groups, and it was greater in post-operative intrathecal morphine group (Group III) than in pre-emptive in-trathecal morphine group (Group II).","['Ninety patients of American Society of Anesthesiologists physical statuses', 'intra-operative surgical stress response and post-operative pain']","['intrathecal morphine', 'morphine', 'Pre-emptive versus post-operative intrathecal morphine injection', 'Morphine sulfate consumption', 'laminectomy']","['serum cortisol level, the number of patients needing post-operative rescue analgesia, its duration, and the total amount required', 'visual analog score', 'rescue analgesia', 'serum cortisol levels']","[{'cui': 'C3816959', 'cui_str': 'Ninety'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]","[{'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C4074555', 'cui_str': 'Morphine Injection [Duramorph]'}, {'cui': 'C0066814', 'cui_str': 'Morphine Sulfate'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0022983', 'cui_str': 'Laminectomy'}]","[{'cui': 'C0236396', 'cui_str': 'Serum cortisol measurement'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C1265611', 'cui_str': 'Quantity finding'}, {'cui': 'C0234621', 'cui_str': 'Visual (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.0256395,"There was a greater need for post-operative rescue morphine in general anesthesia group (Group I) than in the other two groups, and it was greater in post-operative intrathecal morphine group (Group III) than in pre-emptive in-trathecal morphine group (Group II).","[{'ForeName': 'Amany Faheem Abd El', 'Initials': 'AFAE', 'LastName': 'Salam Omara', 'Affiliation': 'Department of Anesthesiology and Surgical Intensive Care, Faculty of Medicine, Tanta University, Tanta, Egypt.'}, {'ForeName': 'Asmaa Fawzy', 'Initials': 'AF', 'LastName': 'Amer', 'Affiliation': 'Department of Anesthesiology and Surgical Intensive Care, Faculty of Medicine, Tanta University, Tanta, Egypt.'}]",Journal of opioid management,['10.5055/jom.2020.0546'] 3059,31081924,A Randomized Trial of Combined tDCS Over Right Inferior Frontal Cortex and Cognitive Bias Modification: Null Effects on Drinking and Alcohol Approach Bias.,"BACKGROUND Deriving novel treatments for alcohol use disorders (AUDs) is of critical importance, as existing treatments are only modestly effective for reducing drinking. Two promising strategies for treating AUDs include cognitive bias modification (CBM) and transcranial direct current stimulation (tDCS). While each strategy has shown positive results in reducing drinking or alcohol-related constructs (e.g., craving), initial tests of the combination of CBM and tDCS have shown mixed results. The present study investigated the degree to which combining CBM and tDCS (2.0 mA anodal current over F10) could reduce alcohol approach biases and alcohol consumption. METHODS Seventy-nine at-risk drinkers were randomized to 1 of 4 conditions in a 2 × 2 factorial design: verum CBM/verum tDCS, verum CBM/sham tDCS, sham CBM/verum tDCS, or sham CBM/sham tDCS. Participants completed a baseline assessment of alcohol approach bias and drinking quantity/frequency (i.e., drinks per drinking day [DDD] and percent heavy drinking days [PHDD]), 4 sessions of combined CBM and tDCS, and follow-up assessments of approach bias and alcohol consumption. RESULTS Results indicated that while participants did demonstrate significant alcohol approach biases at baseline, neither CBM, tDCS, nor the interaction reduced the bias at the follow-up. In addition, there was evidence of a trend toward reducing DDD from baseline to the 1-week/1-month follow-ups, but there was no significant effect of the intervention on either DDD or PHDD. CONCLUSIONS These results partially replicated null results presented in similar CBM/tDCS trials and suggest that this combination, at least with anodal stimulation over dorsolateral or inferior frontal sites, may have limited utility to reduce drinking.",2019,"RESULTS Results indicated that while participants did demonstrate significant alcohol approach biases at baseline, neither CBM, tDCS, nor the interaction reduced the bias at the follow-up.",['Seventy-nine at-risk drinkers'],"['Combined tDCS', 'CBM and tDCS (2.0 mA anodal current over F10', 'verum CBM/verum tDCS, verum CBM/sham tDCS, sham CBM/verum tDCS, or sham CBM/sham tDCS']","['DDD', 'cognitive bias modification (CBM) and transcranial direct current stimulation (tDCS', 'alcohol approach bias and drinking quantity/frequency (i.e., drinks per drinking day [DDD] and percent heavy drinking days [PHDD]), 4 sessions of combined CBM and tDCS, and follow-up assessments of approach bias and alcohol consumption', 'alcohol approach biases']","[{'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C1444641', 'cui_str': 'At risk'}]","[{'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}]","[{'cui': 'C0011037', 'cui_str': 'Dichlorodiphenyldichloroethane'}, {'cui': 'C0005346', 'cui_str': 'Bias'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0001975', 'cui_str': 'Alcohols'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0684271', 'cui_str': 'Drinkings'}, {'cui': 'C1265611', 'cui_str': 'Quantity finding'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0452428', 'cui_str': 'Drinks (substance)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0439165', 'cui_str': 'Percent (property) (qualifier value)'}, {'cui': 'C0439539', 'cui_str': 'Heavy sensation quality'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0001948', 'cui_str': 'Alcohol Drinking'}]",,0.0335608,"RESULTS Results indicated that while participants did demonstrate significant alcohol approach biases at baseline, neither CBM, tDCS, nor the interaction reduced the bias at the follow-up.","[{'ForeName': 'Eric D', 'Initials': 'ED', 'LastName': 'Claus', 'Affiliation': 'The Mind Research Network, Albuquerque, New Mexico.'}, {'ForeName': 'Stefan D', 'Initials': 'SD', 'LastName': 'Klimaj', 'Affiliation': 'The Mind Research Network, Albuquerque, New Mexico.'}, {'ForeName': 'Roberta', 'Initials': 'R', 'LastName': 'Chavez', 'Affiliation': 'Center on Alcoholism, Substance Abuse, and Addiction, University of New Mexico, Albuquerque, New Mexico.'}, {'ForeName': 'Amber D', 'Initials': 'AD', 'LastName': 'Martinez', 'Affiliation': 'Center on Alcoholism, Substance Abuse, and Addiction, University of New Mexico, Albuquerque, New Mexico.'}, {'ForeName': 'Vincent P', 'Initials': 'VP', 'LastName': 'Clark', 'Affiliation': 'The Mind Research Network, Albuquerque, New Mexico.'}]","Alcoholism, clinical and experimental research",['10.1111/acer.14111'] 3060,31323594,Does rTMS on brain areas of mirror neurons lead to higher improvements on symptom severity and empathy compared to the rTMS standard procedure? - Results from a double-blind interventional study in individuals with major depressive disorders.,"BACKGROUND A key feature of major depressive disorders is the lack of emotional processing such as empathy. To counter this, we tested, if brain stimulation on areas rich of mirror neurons on the left inferior parietal lobe (lIPL) might improve emotional processing, including empathy, compared to a standard brain stimulation on the left dorsolateral prefrontal cortex (lDLPFC). METHODS Twenty inpatients (mean age: 38.9 years; 55% females) with severe major depressive disorders and stable treatment of sertraline at therapeutic dosages were randomly assigned to either the rTMS condition on areas of mirror neuron stimulation, that is, the left inferior parietal lobe (rTMS-lIPL), or to the left dorsolateral prefrontal cortex (rTMS-lDLPFC; control condition). Interventions lasted for two consecutive weeks (2 × 5 interventions of 30'). At baseline and at the end of the study, patients completed questionnaires on current mood state and emotion regulation. In parallel, experts rated patients' depression severity. RESULTS Mood improved over time, but more so in the control condition, compared to the rTMS-lIPL condition (medium-large effect sizes). Emotion regulation improved over time; specifically, empathy improved, but only in the rTMS-lIPL condition, compared to the control condition. Symptoms of depression decreased over time, but more so in the rTMS- lIPL condition. CONCLUSIONS The pattern of results suggests that among inpatients with severe major depressive disorders, and compared to a standard procedure of rTMS, rTMS targeting on areas rich of mirror neurons appeared to improve emotion regulation, and specifically empathy, while there was no advantage on acute mood.",2019,"RESULTS Mood improved over time, but more so in the control condition, compared to the rTMS-lIPL condition (medium-large effect sizes).","['inpatients with severe major depressive disorders', 'individuals with major depressive disorders', 'Twenty inpatients (mean age: 38.9 years; 55% females) with severe major depressive disorders and stable treatment of sertraline at therapeutic dosages']","['rTMS condition on areas of mirror neuron stimulation, that is, the left inferior parietal lobe (rTMS-lIPL), or to the left dorsolateral prefrontal cortex (rTMS-lDLPFC; control condition']","['current mood state and emotion regulation', 'emotion regulation', 'Symptoms of depression', 'Emotion regulation', 'symptom severity and empathy']","[{'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0074393', 'cui_str': 'Sertraline'}, {'cui': 'C0178602', 'cui_str': 'Dosages (qualifier value)'}]","[{'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C3178760', 'cui_str': 'Mirror Neurons'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0542339', 'cui_str': 'Below (qualifier value)'}, {'cui': 'C0030560', 'cui_str': 'Parietal Cortex'}, {'cui': 'C0450424', 'cui_str': 'To the left (qualifier value)'}, {'cui': 'C4019080', 'cui_str': 'Dorsolateral Prefrontal Cortex'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0013987', 'cui_str': 'Emotions'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity (finding)'}, {'cui': 'C0013989', 'cui_str': 'Empathy'}]",20.0,0.015626,"RESULTS Mood improved over time, but more so in the control condition, compared to the rTMS-lIPL condition (medium-large effect sizes).","[{'ForeName': 'Leila', 'Initials': 'L', 'LastName': 'Jahangard', 'Affiliation': 'Research Center for Behavioral Disorders and Substances Abuse, Hamadan University of Medical Sciences, Hamadan, Iran.'}, {'ForeName': 'Mojtaba', 'Initials': 'M', 'LastName': 'Tayebi', 'Affiliation': 'Research Center for Behavioral Disorders and Substances Abuse, Hamadan University of Medical Sciences, Hamadan, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Haghighi', 'Affiliation': 'Research Center for Behavioral Disorders and Substances Abuse, Hamadan University of Medical Sciences, Hamadan, Iran.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Ahmadpanah', 'Affiliation': 'Research Center for Behavioral Disorders and Substances Abuse, Hamadan University of Medical Sciences, Hamadan, Iran.'}, {'ForeName': 'Edith', 'Initials': 'E', 'LastName': 'Holsboer-Trachsler', 'Affiliation': 'University of Basel, Psychiatric Clinics, Center for Affective, Stress and Sleep Disorders, Basel, Switzerland.'}, {'ForeName': 'Dena', 'Initials': 'D', 'LastName': 'Sadeghi Bahmani', 'Affiliation': 'University of Basel, Psychiatric Clinics, Center for Affective, Stress and Sleep Disorders, Basel, Switzerland; Kermanshah University of Medical Sciences, Department of Psychiatry, Substance Abuse Prevention Research Center, Kermanshah, Iran; Kermanshah University of Medical Sciences, Department of Psychiatry, Sleep Disturbances Research Center, Kermanshah, Iran; Isfahan University of Medical Sciences Isfahan Neurosciences Research Center, Alzahra Research Institute, Isfahan, Iran.'}, {'ForeName': 'Serge', 'Initials': 'S', 'LastName': 'Brand', 'Affiliation': 'University of Basel, Psychiatric Clinics, Center for Affective, Stress and Sleep Disorders, Basel, Switzerland; Kermanshah University of Medical Sciences, Department of Psychiatry, Substance Abuse Prevention Research Center, Kermanshah, Iran; Isfahan University of Medical Sciences Isfahan Neurosciences Research Center, Alzahra Research Institute, Isfahan, Iran; University of Basel, Department of Sport, Exercise and Health, Division of Sport Science and Psychosocial Health, Basel, Switzerland. Electronic address: serge.brand@upk.ch.'}]",Journal of affective disorders,['10.1016/j.jad.2019.07.019'] 3061,31388226,Is it time to revise the acclimatization schedule at high altitude? Evidence from a field trial in Western Himalayas.,"Background In Western Himalayas, Indian Army soldiers take 11 days (6 days of acclimatization and 5 days of travel) on a sea-level to high altitude road (SH road) to reach a high altitude location (HAL) situated at an altitude of 11,500 feet from sea-level location (SLL) at an altitude of 1150 feet while following acclimatization schedule (AS). AS has an extra safety margin over the conventional 'mountaineering thumb rule' of not exceeding 500 m sleeping altitude above 3000 m altitude. We carried out this randomised field trial to study the feasibility of moving large number of troops rapidly from SLL to HAL on SH road in western Himalayas in 4 days under pharmaco-prophylaxis. Methods Based on the pharmaco-prophylaxis, at SLL 508 healthy lowland soldiers were divided into two groups: 'A' ( n  = 256) with Acetazolamide + Dexamethasone and 'B' ( n  = 252) with Acetazolamide + Placebo. They travelled rapidly by road to HAL in 4 days and prevalence of acute mountain sickness (AMS), high altitude pulmonary edema (HAPE) and high altitude cerebral edema (HACE) during the ascent was measured. Results Prevalence of AMS was found to be 1.56% and 1.59% in group 'A' and group 'B' respectively during the ascent with no cases of HAPE and HACE. Conclusion At least on SH road, troops can be inducted rapidly to HAL from SLL in 4 days under pharmaco-prophylaxis with Acetazolamide with minimal occurrence of acute high altitude illnesses.",2019,AS has an extra safety margin over the conventional 'mountaineering thumb rule' of not exceeding 500 m sleeping altitude above 3000 m altitude.,"['SLL 508 healthy lowland soldiers', '\n\n\nIn Western Himalayas', 'SH road in western Himalayas in 4 days under pharmaco-prophylaxis']","[""Acetazolamide\xa0+\xa0Dexamethasone and 'B"", 'Acetazolamide\xa0+\xa0Placebo', 'Acetazolamide', 'SLL to HAL']","['acute mountain sickness (AMS), high altitude pulmonary edema (HAPE) and high altitude cerebral edema (HACE', 'Prevalence of AMS']","[{'cui': 'C0524647', 'cui_str': 'Soldiers'}, {'cui': 'C0442650', 'cui_str': 'Road (environment)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0033107', 'cui_str': 'prophylaxis'}]","[{'cui': 'C0000981', 'cui_str': 'Acetazolamide'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0238284', 'cui_str': 'Acute mountain sickness (disorder)'}, {'cui': 'C0340100', 'cui_str': 'Pulmonary edema of mountaineers'}, {'cui': 'C0472390', 'cui_str': 'High altitude cerebral edema (disorder)'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}]",508.0,0.0150893,AS has an extra safety margin over the conventional 'mountaineering thumb rule' of not exceeding 500 m sleeping altitude above 3000 m altitude.,"[{'ForeName': 'Gaurav', 'Initials': 'G', 'LastName': 'Sikri', 'Affiliation': 'Professor and Head, Department of Physiology, Armed Forces Medical College, Pune, 411040, India.'}, {'ForeName': 'Atul', 'Initials': 'A', 'LastName': 'Kotwal', 'Affiliation': ""Dy DGAFMS (Pensions), O/o DGAFMS, Ministry of Defence, 'M' Block, New Delhi, 110001, India.""}, {'ForeName': 'S P', 'Initials': 'SP', 'LastName': 'Singh', 'Affiliation': 'Professor, Department of Physiology, Armed Forces Medical College, Pune, 411040, India.'}, {'ForeName': 'Srinivasa', 'Initials': 'S', 'LastName': 'Bhattachar', 'Affiliation': 'Assistant Professor, Department of Physiology, Armed Forces Medical College, Pune, 411040, India.'}, {'ForeName': 'S S', 'Initials': 'SS', 'LastName': 'Bhatia', 'Affiliation': 'Commandant, Military Hospital Mhow, C/o 56 APO, India.'}, {'ForeName': 'Manohar', 'Initials': 'M', 'LastName': 'Dutt', 'Affiliation': 'Commanding Officer, 4002 Field Hospital, C/o 56 APO, India.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Srinath', 'Affiliation': ""Consultant (Surgery), O/o DGAFMS, Ministry of Defence, 'M' Block, New Delhi, 110001, India.""}]","Medical journal, Armed Forces India",['10.1016/j.mjafi.2018.01.001'] 3062,31388227,A crossover comparative study to assess efficacy of competency based medical education (CBME) and the traditional structured (TS) method in selected competencies of living anatomy of first year MBBS curriculum: A pilot study.,"Background Competency based medical education (CBME) is outcome based teaching methodology where a student learns a set of measurable competencies for early clinical exposure. Inspite of ample resources on CBME, there are limited studies on its implementation. This study will try to demonstrate improvement in the performance of students using CBME as a teaching tool over the traditional structured method (TS). Methods Forty student volunteers were chosen and divided into two groups. The crossover design exposed the group of students to CBME and TS spread over two periods with a wash out period in between. The intervention group was exposed to selected list of competencies in living Anatomy with feedbacks and formative assessments. The summative assessments were held at the end of each period. Results The mean scores of CBME and TS in group 1 is 130.625 and 113.65 while in group 2 is 139.425 and 112.075 respectively. The treatment and period effect is significant. Estimate of treatment effect is 22.1625. The average improvement in treatment scores is by 11%. Two tailed paired sample T test reveals significant improvement in the scores post intervention. Conclusion CBME method produces better performance of the students in the competencies of living anatomy.",2019,The mean scores of CBME and TS in group 1 is 130.625 and 113.65 while in group 2 is 139.425 and 112.075 respectively.,"['Forty student volunteers', 'selected competencies of living anatomy of first year MBBS curriculum']","['\n\n\nCompetency based medical education (CBME', 'competency based medical education (CBME) and the traditional structured (TS']",['mean scores of CBME and TS'],"[{'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0002808', 'cui_str': 'Anatomy'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0220815', 'cui_str': 'curriculum'}]","[{'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0013631', 'cui_str': 'Education, Medical'}, {'cui': 'C0443324', 'cui_str': 'Traditional (qualifier value)'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",40.0,0.0354236,The mean scores of CBME and TS in group 1 is 130.625 and 113.65 while in group 2 is 139.425 and 112.075 respectively.,"[{'ForeName': 'Subhendu', 'Initials': 'S', 'LastName': 'Pandit', 'Affiliation': 'Classified Specialist & Professor (Anatomy), Army Hospital (R&R), Delhi Cantt 110010, India.'}, {'ForeName': 'Merlin R', 'Initials': 'MR', 'LastName': 'Thomas', 'Affiliation': 'Resident, Department of Anatomy, Armed Forces Medical College, Pune 411040, India.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Banerjee', 'Affiliation': 'Resident, Department of Anatomy, Armed Forces Medical College, Pune 411040, India.'}, {'ForeName': 'Mohan', 'Initials': 'M', 'LastName': 'Angadi', 'Affiliation': 'Resident, Department of Anatomy, Armed Forces Medical College, Pune 411040, India.'}, {'ForeName': 'Sushil', 'Initials': 'S', 'LastName': 'Kumar', 'Affiliation': 'Professor and Head, Department of Anatomy, Armed Forces Medical College, Pune 411040, India.'}, {'ForeName': 'Aseem', 'Initials': 'A', 'LastName': 'Tandon', 'Affiliation': 'Associate Professor, Department of Anatomy, Armed Forces Medical College, Pune 411040, India.'}, {'ForeName': 'Tripti', 'Initials': 'T', 'LastName': 'Shrivastava', 'Affiliation': 'Associate Professor, Department of Anatomy, Armed Forces Medical College, Pune 411040, India.'}, {'ForeName': 'Debasis', 'Initials': 'D', 'LastName': 'Bandopadhyay', 'Affiliation': 'Assistant Professor, Department of Anatomy, Armed Forces Medical College, Pune 411040, India.'}, {'ForeName': 'V D S', 'Initials': 'VDS', 'LastName': 'Jamwal', 'Affiliation': 'Assistant Professor, Department of Anatomy, Armed Forces Medical College, Pune 411040, India.'}, {'ForeName': 'D R', 'Initials': 'DR', 'LastName': 'Basannar', 'Affiliation': ""Scientist 'F', Department of Community Medicine, Armed Forces Medical College, Pune 411040, India.""}]","Medical journal, Armed Forces India",['10.1016/j.mjafi.2018.01.010'] 3063,31300842,Comparison of needle aspiration versus incision and drainage under local anaesthesia for the initial treatment of peritonsillar abscess.,"PURPOSE The treatment of peritonsillar abscess (PTA) is still controversial regarding the best method of drainage to perform. This study aims to compare effectiveness and safety of needle aspiration versus incision and drainage under local anaesthesia for the initial treatment of PTA. METHODS A retrospective review of patients (age > 15 years) admitted in two tertiary medical centres for a PTA between November 2010 and October 2016 was performed. Patients were divided into two groups according to the type of drainage: needle aspiration or incision and drainage, under local anaesthesia. The primary outcome was the length of hospital stay; the need to repeat the procedure or to go to the operating room was also assessed. Complications or adverse events were listed in each group to assess safety. RESULTS Over a 6-year period, 182 patients were admitted for a PTA and included in the analysis, with 82 patients in the aspiration group and 100 patients in the incision group. Mean age was 36.3 years, with a sex ratio of 1.33. The length of hospital stay ranged from 1 to 7 days (mean 2.7 days, median 2 days) with a median length of stay of 3.0 days (interquartile range 2-4) in the aspiration group versus 2.0 days (IQR 2-3) in patients who underwent incision and drainage (p = 0.009). A repetition of the needle aspiration was made for 46.3% of patients versus 10% of repetition of the procedure in the incision group (p = 0.0001). 12 patients (14%) of the aspiration group and 4 patients (4%) of the incision group required an additional drainage under general anaesthesia (p < 0.001). We found no differences regarding safety in both groups. CONCLUSION Our study showed a significant decrease in the length of hospital stay in patients admitted for a PTA who underwent an initial incision and drainage under local anaesthesia, compared to needle aspiration, as well as a lower risk of repeating the procedure. A well-designed prospective and randomized study on a larger sample of patients is required to support these findings.",2019,A repetition of the needle aspiration was made for 46.3% of patients versus 10% of repetition of the procedure in the incision group (p = 0.0001).,"['peritonsillar abscess', '182 patients were admitted for a PTA and included in the analysis, with 82 patients in the aspiration group and 100 patients in the incision group', 'patients admitted for a PTA who underwent an initial incision and drainage under local anaesthesia', 'peritonsillar abscess (PTA', 'patients (age\u2009>\u200915\xa0years) admitted in two tertiary medical centres for a PTA between November 2010 and October 2016 was performed', 'Mean age was 36.3\xa0years, with a sex ratio of 1.33']","['drainage: needle aspiration or incision and drainage, under local anaesthesia', 'needle aspiration versus incision and drainage under local anaesthesia']","['A repetition of the needle aspiration', 'length of hospital stay; the need to repeat the procedure or to go to the operating room', 'length of hospital stay', 'additional drainage under general anaesthesia', 'Complications or adverse events', 'median length of stay']","[{'cui': 'C0031157', 'cui_str': 'Peritonsillar Abscess'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0015522', 'cui_str': 'Factor Eleven'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0349707', 'cui_str': 'Aspiration - action (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0184898', 'cui_str': 'Incision - attribute'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0152277', 'cui_str': 'Incision AND drainage (procedure)'}, {'cui': 'C1720162', 'cui_str': 'Under local anesthesia'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205372', 'cui_str': 'Tertiary (qualifier value)'}, {'cui': 'C0565990', 'cui_str': 'Medical center (environment)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0036893', 'cui_str': 'Sex Ratio'}, {'cui': 'C4517500', 'cui_str': '1.33 (qualifier value)'}]","[{'cui': 'C0013103', 'cui_str': 'Drainage'}, {'cui': 'C0398296', 'cui_str': 'Cannulation of vascular fistula, graft or prosthetic device (procedure)'}, {'cui': 'C0349707', 'cui_str': 'Aspiration - action (qualifier value)'}, {'cui': 'C0152277', 'cui_str': 'Incision AND drainage (procedure)'}, {'cui': 'C1720162', 'cui_str': 'Under local anesthesia'}]","[{'cui': 'C0205341', 'cui_str': 'Repeat (qualifier value)'}, {'cui': 'C0398296', 'cui_str': 'Cannulation of vascular fistula, graft or prosthetic device (procedure)'}, {'cui': 'C0349707', 'cui_str': 'Aspiration - action (qualifier value)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}, {'cui': 'C0029064', 'cui_str': 'Operating Room'}, {'cui': 'C0013103', 'cui_str': 'Drainage'}, {'cui': 'C1719976', 'cui_str': 'Under general anesthesia'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0023303', 'cui_str': 'Length of Stay'}]",182.0,0.0364399,A repetition of the needle aspiration was made for 46.3% of patients versus 10% of repetition of the procedure in the incision group (p = 0.0001).,"[{'ForeName': 'C', 'Initials': 'C', 'LastName': 'Mansour', 'Affiliation': ""Service d'ORL et de chirurgie cervico-faciale, CHU de toulouse, hôpital Larrey, 24, chemin de Pouvourville, TSA 30030, 31059, Toulouse cedex 9, France. charlesmansour.09@gmail.com.""}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'De Bonnecaze', 'Affiliation': ""Service d'ORL et de chirurgie cervico-faciale, CHU de toulouse, hôpital Larrey, 24, chemin de Pouvourville, TSA 30030, 31059, Toulouse cedex 9, France.""}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Mouchon', 'Affiliation': ""Service d'ORL et de chirurgie cervico-faciale, CHU de toulouse, hôpital Larrey, 24, chemin de Pouvourville, TSA 30030, 31059, Toulouse cedex 9, France.""}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Gallini', 'Affiliation': ""Service d'épidémiologie, CHU de Toulouse, 31000, Toulouse, France.""}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Vergez', 'Affiliation': ""Service d'ORL et de chirurgie cervico-faciale, CHU de toulouse, hôpital Larrey, 24, chemin de Pouvourville, TSA 30030, 31059, Toulouse cedex 9, France.""}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Serrano', 'Affiliation': ""Service d'ORL et de chirurgie cervico-faciale, CHU de toulouse, hôpital Larrey, 24, chemin de Pouvourville, TSA 30030, 31059, Toulouse cedex 9, France.""}]",European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery,['10.1007/s00405-019-05542-1'] 3064,32106189,Impact of an Immersive Virtual Reality Curriculum on Medical Students' Clinical Assessment of Infants With Respiratory Distress.,"OBJECTIVE To determine whether exposure to an immersive virtual reality curriculum on pediatric respiratory distress improves medical students' recognition of impending respiratory failure. DESIGN Randomized, controlled, prospective study conducted from July 2017 to June 2018. Evaluators blinded to student groupings. SETTING Academic, free-standing children's hospital. PARTICIPANTS All third-year medical students (n = 168) were eligible. The standard curriculum was delivered to all students during their pediatric rotation with optional inclusion of research data per Institutional Review Board review. A randomized selection of students was exposed to the virtual reality curriculum. INTERVENTION All students received standard training on respiratory distress through didactics and high-fidelity mannequin simulation. Intervention students underwent an additional 30-minute immersive virtual reality curriculum, experienced through an OculusRift headset, with three simulations of an infant with 1) no distress, 2) respiratory distress, and 3) impending respiratory failure. MEASUREMENTS AND MAIN RESULTS The impact of the virtual reality curriculum on recognition/interpretation of key examination findings, assignment of an appropriate respiratory status assessment, and recognition of the need for escalation of care for patients in impending respiratory failure was assessed via a free response clinical assessment of video vignettes at the end of the pediatric rotation. Responses were scored on standardized rubrics by physician experts. All eligible students participated (78 intervention and 90 control). Significant differences between intervention and control were demonstrated for consideration/interpretation of mental status (p < 0.01), assignment of the appropriate respiratory status assessment (p < 0.01), and recognition of a need for escalation of care (p = 0.0004). CONCLUSIONS Exposure to an immersive virtual reality curriculum led to improvement in objective competence at the assessment of respiratory distress and recognition of the need for escalation of care for patients with signs of impending respiratory failure. This study represents a novel application of immersive virtual reality and suggests that it may be effective for clinical assessment training.",2020,"Significant differences between intervention and control were demonstrated for consideration/interpretation of mental status (p < 0.01), assignment of the appropriate respiratory status assessment (p < 0.01), and recognition of a need for escalation of care (p = 0.0004). ","['Infants With Respiratory Distress', 'All eligible students participated (78 intervention and 90 control', ""Academic, free-standing children's hospital"", 'All third-year medical students (n = 168) were eligible', 'patients with signs of impending respiratory failure', 'from July 2017 to June 2018']","['additional 30-minute immersive virtual reality curriculum, experienced through an OculusRift headset, with three simulations of an infant with 1) no distress, 2) respiratory distress, and 3) impending respiratory failure', 'virtual reality curriculum', 'Immersive Virtual Reality Curriculum', 'immersive virtual reality curriculum', 'standard training']","['consideration/interpretation of mental status', 'recognition of a need for escalation of care', 'objective competence']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0476273', 'cui_str': 'Respiratory distress (finding)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C3888057', 'cui_str': 'Stand'}, {'cui': 'C0020017', 'cui_str': 'Hospitals, Pediatric'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0038495', 'cui_str': 'Students, Medical'}, {'cui': 'C4319556', 'cui_str': 'One hundred and sixty-eight'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0311392', 'cui_str': 'Sign'}, {'cui': 'C0332190', 'cui_str': 'Impending (qualifier value)'}, {'cui': 'C3889105', 'cui_str': 'Respiratory failure (SMQ)'}]","[{'cui': 'C1442458', 'cui_str': 'Thirty minutes (qualifier value)'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0220815', 'cui_str': 'curriculum'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0476273', 'cui_str': 'Respiratory distress (finding)'}, {'cui': 'C0332190', 'cui_str': 'Impending (qualifier value)'}, {'cui': 'C3889105', 'cui_str': 'Respiratory failure (SMQ)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}]","[{'cui': 'C0459471', 'cui_str': 'Interpretation (attribute)'}, {'cui': 'C0278060', 'cui_str': 'Mental status'}, {'cui': 'C0524637', 'cui_str': 'Recognition (Psychology)'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0086035', 'cui_str': 'Competence'}]",168.0,0.0875961,"Significant differences between intervention and control were demonstrated for consideration/interpretation of mental status (p < 0.01), assignment of the appropriate respiratory status assessment (p < 0.01), and recognition of a need for escalation of care (p = 0.0004). ","[{'ForeName': 'Matthew W', 'Initials': 'MW', 'LastName': 'Zackoff', 'Affiliation': 'Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, OH.'}, {'ForeName': 'Francis J', 'Initials': 'FJ', 'LastName': 'Real', 'Affiliation': 'Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, OH.'}, {'ForeName': 'Rashmi D', 'Initials': 'RD', 'LastName': 'Sahay', 'Affiliation': 'Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, OH.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Fei', 'Affiliation': 'Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, OH.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Guiot', 'Affiliation': 'Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, OH.'}, {'ForeName': 'Corinne', 'Initials': 'C', 'LastName': 'Lehmann', 'Affiliation': 'Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, OH.'}, {'ForeName': 'Ken', 'Initials': 'K', 'LastName': 'Tegtmeyer', 'Affiliation': 'Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, OH.'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Klein', 'Affiliation': 'Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, OH.'}]",Pediatric critical care medicine : a journal of the Society of Critical Care Medicine and the World Federation of Pediatric Intensive and Critical Care Societies,['10.1097/PCC.0000000000002249'] 3065,32012284,Detection of Inflicted Bruises by Alternate Light: Results of a Randomized Controlled Trial.,"Bruises are often difficult to detect on victims of violence, potentially impacting investigation and prosecution. The purpose of our randomized controlled trial was to measure the effectiveness of an alternate light source (ALS) within visible and long ultraviolet spectrums at improving bruise detection compared to white light over time. We also examined the effects of skin color, age, gender, localized fat, and injury mechanism on bruise detection. Participants included 157 healthy adults with balanced sampling across six skin color categories. Bruises were created under the controlled application of a paintball pellet and dropped weight to one upper and lower arm, respectively. Using a crossover design, both bruises were examined 21 times over 4 weeks. Ten different wavelength (350-535 nm) and filter (yellow, orange, red) combinations were used. Multilevel models were used to analyze 2903 examinations on both upper and lower arms. Results in multivariable models showed after controlling for other covariates 415 and 450 nm using a yellow filter had greater odds of detecting evidence of bruising than white light (Upper Arm: 415 nm: OR = 5.34, 95% CI: 4.35-6.56; 450 nm: OR = 4.08, 95% CI: 3.36-4.96). Under either light source, being female and having more localized fat had increased odds of detecting bruises created by the dropped weight (female: OR = 2.96, 95% CI: 2.37-3.70; fat: OR = 1.21, 95% CI: 1.09-1.34). Our results support ALS as an appropriate tool to enhance concurrent physical assessment of bruises in the presence of known history of injury. Future development and evaluation of clinical practice guidelines for ALS application are needed.",2020,"Under either light source, being female and having more localized fat had increased odds of detecting bruises created by the dropped weight (female: OR = 2.96, 95% CI: 2.37-3.70; fat: OR = ","['Participants included 157 healthy adults with balanced sampling across six skin color categories', '415\xa0nm: OR\xa0']",['alternate light source (ALS'],[],"[{'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0037290', 'cui_str': 'Skin Tone'}, {'cui': 'C4517772', 'cui_str': 'Four hundred and fifteen'}]","[{'cui': 'C0332270', 'cui_str': 'Alternating (qualifier value)'}, {'cui': 'C0181633', 'cui_str': 'Light source'}]",[],157.0,0.0409469,"Under either light source, being female and having more localized fat had increased odds of detecting bruises created by the dropped weight (female: OR = 2.96, 95% CI: 2.37-3.70; fat: OR = ","[{'ForeName': 'Katherine N', 'Initials': 'KN', 'LastName': 'Scafide', 'Affiliation': 'College of Health and Human Services, George Mason University, 4400 University Drive, Fairfax, VA, 22030.'}, {'ForeName': 'Daniel J', 'Initials': 'DJ', 'LastName': 'Sheridan', 'Affiliation': 'College of Nursing, Texas A&M University Health Sciences Center, 8447 Riverside Parkway, Bryan, TX, 77807.'}, {'ForeName': 'Nancy R', 'Initials': 'NR', 'LastName': 'Downing', 'Affiliation': 'College of Nursing, Texas A&M University Health Sciences Center, 8447 Riverside Parkway, Bryan, TX, 77807.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Hayat', 'Affiliation': 'School of Public Health, Georgia State University, 140 Decatur Street, Atlanta, GA, 30303.'}]",Journal of forensic sciences,['10.1111/1556-4029.14294'] 3066,31378980,Nutrient supplementation during the first 1000 days and growth of infants born to pregnant adolescents.,"Few studies have evaluated the impact of nutritional supplementation among pregnant adolescents. We examined the effects of the Rang Din Nutrition Study (RDNS) interventions on children born to mothers <20 years of age. The RDNS was a cluster-randomized effectiveness trial with four arms: (1) women and children both received small-quantity lipid-based nutrient supplements (LNS-LNS), (2) women received iron and folic acid (IFA) and children received LNS (IFA-LNS), (3) women received IFA and children received micronutrient powder (MNP) (IFA-MNP), and (4) women received IFA and children received no supplements (IFA-Control). We enrolled 4011 women at <20 weeks gestation; 1552 were adolescents. Among adolescents, prenatal LNS reduced newborn stunting by 25% and small head size by 28% and had a marginally significant effect on newborn wasting, compared with IFA. Low birth weight and preterm birth were reduced only among adolescents with lower food security. Effects on subsequent growth status were observed only among female children in the LNS-LNS group: less stunting at 18 months (versus IFA-MNP) and lower prevalence of small head circumference and wasting at 24 months (versus IFA-Control). Initiatives targeting pregnant adolescents in similar settings should consider inclusion of small-quantity LNS, particularly for adolescents living in food-insecure households.",2020,Effects on subsequent growth status were observed only among female children in the LNS-LNS group: less stunting at 18 months (versus IFA-MNP) and lower prevalence of small head circumference and wasting at 24 months (versus IFA-Control).,"['adolescents living in food-insecure households', 'We enrolled 4011 women at <20 weeks gestation; 1552 were adolescents', 'children born to mothers <20 years of age', 'infants born to pregnant adolescents', 'pregnant adolescents']","['Rang Din Nutrition Study (RDNS) interventions', 'Nutrient supplementation', 'small-quantity lipid-based nutrient supplements (LNS-LNS), (2) women received iron and folic acid (IFA) and children received LNS (IFA-LNS), (3) women received IFA and children received micronutrient powder (MNP) (IFA-MNP), and (4) women received IFA and children received no supplements (IFA-Control']","['Low birth weight and preterm birth', 'subsequent growth status', 'newborn wasting', 'newborn stunting']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0549206', 'cui_str': 'Pregnancy not delivered'}]","[{'cui': 'C1442959', 'cui_str': 'Nutrition, function (observable entity)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0242295', 'cui_str': 'Dietary Supplementations'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C1265611', 'cui_str': 'Quantity finding'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0678695', 'cui_str': 'Nutrients'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0337439', 'cui_str': 'Iron measurement (procedure)'}, {'cui': 'C0016410', 'cui_str': 'Folic Acid'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0282575', 'cui_str': 'Micronutrients'}, {'cui': 'C0032861', 'cui_str': 'Powdered drug preparation'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0024032', 'cui_str': 'Low Birth Weights'}, {'cui': 'C0151526', 'cui_str': 'Premature Birth'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C0235394', 'cui_str': 'Wasting'}, {'cui': 'C0018273', 'cui_str': 'Stunting'}]",1552.0,0.0901711,Effects on subsequent growth status were observed only among female children in the LNS-LNS group: less stunting at 18 months (versus IFA-MNP) and lower prevalence of small head circumference and wasting at 24 months (versus IFA-Control).,"[{'ForeName': 'Kathryn G', 'Initials': 'KG', 'LastName': 'Dewey', 'Affiliation': 'Department of Nutrition, University of California, Davis, California.'}, {'ForeName': 'Susana L', 'Initials': 'SL', 'LastName': 'Matias', 'Affiliation': 'Department of Nutrition, University of California, Davis, California.'}, {'ForeName': 'Malay K', 'Initials': 'MK', 'LastName': 'Mridha', 'Affiliation': 'Department of Nutrition, University of California, Davis, California.'}, {'ForeName': 'Charles D', 'Initials': 'CD', 'LastName': 'Arnold', 'Affiliation': 'Department of Nutrition, University of California, Davis, California.'}]",Annals of the New York Academy of Sciences,['10.1111/nyas.14191'] 3067,32035035,Effectiveness and cost-effectiveness of group support psychotherapy delivered by trained lay health workers for depression treatment among people with HIV in Uganda: a cluster-randomised trial.,"BACKGROUND WHO recommends the use of psychological interventions as first-line treatment for depression in low-income and middle-income countries. However, evaluations of the effectiveness and cost-effectiveness of such interventions among people with HIV are scarce. Our aim was to establish the effectiveness of group support psychotherapy (GSP) delivered by lay health workers for depression treatment among people living with HIV in a rural area of Uganda on a large scale. METHODS In this cluster-randomised trial, we included 30 health centres offering HIV care. These were randomly assigned to deliver either GSP or group HIV education (GHE). Randomisation, in a ratio of 1:1, was achieved by health centre managers separately picking a paper containing the intervention allocation from a basket. Participants were people living with HIV, aged 19 years and older, with mild to moderate major depression assessed with the Mini International Neuropsychiatric Interview depression module, taking antiretroviral therapy, and antidepressant-naive. Group sessions were led by trained lay health workers once a week for 8 weeks. The primary outcomes were the proportion of participants with major depression and function scores at 6 months post-treatment, analysed by intention to treat by means of multilevel random effect regression analyses adjusting for clustering in health centres. This trial is registered with the Pan African Clinical Trials Registry, PACTR201608001738234. FINDINGS Between Sept 13 and Dec 15, 2016, we assessed 1473 individuals, of whom 1140 were recruited from health centres offering GSP (n=578 [51%]) or GHE (n=562 [49%]). Two (<1%) participants in the GSP group were diagnosed with major depression 6 months post-treatment compared with 160 (28%) in the GHE group (adjusted odds ratio=0·01, 95% CI 0·003-0·012, p<0·0001). The mean function scores 6 months post-treatment were 9·85 (SD 0·76) in the GSP group and 6·83 (2·85) in the GHE group (β=4·12; 95% CI 3·75-4·49, p<0·0001). 36 individuals had 63 serious adverse events, which included 25 suicide attempts and 22 hospital admissions for medical complications. The outcomes of these serious adverse events included 16 deaths, 4 of which were completed suicides (GSP=2; GHE=2), and 12 of which were HIV-related medical complications (GSP=8; GHE=4). Cost-effectiveness estimates showed an incremental cost-effectiveness ratio of US$13·0 per disability-adjusted life-year averted, which can be considered very cost-effective in Uganda. INTERPRETATION Integration of cost-effective psychological treatments such as group support psychotherapy into existing HIV interventions might improve the mental health of people living with HIV. FUNDING MQ Transforming Mental Health and Grand Challenges Canada.",2020,"The mean function scores 6 months post-treatment were 9·85 (SD 0·76) in the GSP group and 6·83 (2·85) in the GHE group (β=4·12; 95% CI 3·75-4·49, p<0·0001).","['people with HIV are scarce', 'Between Sept 13 and Dec 15, 2016', 'trained lay health workers for depression treatment among people with HIV in Uganda', 'people living with HIV in a rural area of Uganda on a large scale', '1473 individuals, of whom 1140 were recruited from health centres offering GSP (n=578 [51%]) or GHE (n=562 [49', 'people living with HIV', 'Participants were people living with HIV, aged 19 years and older, with mild to moderate major depression assessed with the Mini International Neuropsychiatric Interview depression module, taking antiretroviral therapy, and antidepressant-naive', '36 individuals had 63 serious adverse events, which included 25 suicide attempts and 22 hospital admissions for medical complications', '30 health centres offering HIV care']","['group support psychotherapy', 'GSP or group HIV education (GHE', 'group support psychotherapy (GSP']","['effectiveness and cost-effectiveness', 'Effectiveness and cost-effectiveness', 'proportion of participants with major depression and function scores', 'mean function scores']","[{'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0600261', 'cui_str': 'Lying'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0041573', 'cui_str': 'Republic of Uganda'}, {'cui': 'C0595998', 'cui_str': 'Household composition (observable entity)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C4517539', 'cui_str': 'One thousand one hundred and forty'}, {'cui': 'C0475309', 'cui_str': 'Health center (environment)'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C4505426', 'cui_str': 'Mini International Neuropsychiatric Interview'}, {'cui': 'C3542953', 'cui_str': 'Module (core metadata concept)'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0003289', 'cui_str': 'Antidepressant Drugs'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0038663', 'cui_str': 'Suicide attempt (event)'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission (procedure)'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}]","[{'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C1273567', 'cui_str': 'Psychotherapy (specialty)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0013621', 'cui_str': 'Education'}]","[{'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",1140.0,0.181347,"The mean function scores 6 months post-treatment were 9·85 (SD 0·76) in the GSP group and 6·83 (2·85) in the GHE group (β=4·12; 95% CI 3·75-4·49, p<0·0001).","[{'ForeName': 'Etheldreda', 'Initials': 'E', 'LastName': 'Nakimuli-Mpungu', 'Affiliation': 'Department of Psychiatry, College of Health Sciences, Makerere University, Kampala, Uganda. Electronic address: ethelnakimuli@chs.mak.ac.ug.'}, {'ForeName': 'Seggane', 'Initials': 'S', 'LastName': 'Musisi', 'Affiliation': 'Department of Psychiatry, College of Health Sciences, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Kizito', 'Initials': 'K', 'LastName': 'Wamala', 'Affiliation': 'Department of Psychology, Center for Victims of Torture, Gulu, Uganda.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Okello', 'Affiliation': 'Department of Mental Health, Faculty of Medicine, Gulu University, Gulu, Uganda.'}, {'ForeName': 'Sheila', 'Initials': 'S', 'LastName': 'Ndyanabangi', 'Affiliation': 'Mental Health Program, Ministry of Health of Uganda, Kampala, Uganda.'}, {'ForeName': 'Josephine', 'Initials': 'J', 'LastName': 'Birungi', 'Affiliation': 'The AIDS Support Organization, Kampala, Uganda.'}, {'ForeName': 'Mastula', 'Initials': 'M', 'LastName': 'Nanfuka', 'Affiliation': 'The AIDS Support Organization, Kampala, Uganda.'}, {'ForeName': 'Micheal', 'Initials': 'M', 'LastName': 'Etukoit', 'Affiliation': 'The AIDS Support Organization, Kampala, Uganda.'}, {'ForeName': 'Chrispus', 'Initials': 'C', 'LastName': 'Mayora', 'Affiliation': 'Department of Health Policy Planning and Management, School of Public Health, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Freddie', 'Initials': 'F', 'LastName': 'Ssengooba', 'Affiliation': 'Department of Health Policy Planning and Management, School of Public Health, Makerere University, Kampala, Uganda.'}, {'ForeName': 'Ramin', 'Initials': 'R', 'LastName': 'Mojtabai', 'Affiliation': 'Department of Mental Health, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'Jean B', 'Initials': 'JB', 'LastName': 'Nachega', 'Affiliation': 'Department of International Health, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD, USA; Department of Epidemiology, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD, USA; Department of Epidemiology, University of Pittsburgh Graduate School of Public Health, Pittsburgh, PA, USA; Infectious Diseases and Microbiology, University of Pittsburgh Graduate School of Public Health, Pittsburgh, PA, USA; Center for Infectious Disease, Department of Medicine, Stellenbosch University Faculty of Medicine and Health Sciences, Cape Town, South Africa.'}, {'ForeName': 'Ofir', 'Initials': 'O', 'LastName': 'Harari', 'Affiliation': 'MTEK Sciences, Vancouver, BC, Canada.'}, {'ForeName': 'Edward J', 'Initials': 'EJ', 'LastName': 'Mills', 'Affiliation': 'MTEK Sciences, Vancouver, BC, Canada; Department of Clinical Epidemiology & Biostatistics, McMaster University, Hamilton, ON, Canada.'}]",The Lancet. Global health,['10.1016/S2214-109X(19)30548-0'] 3068,32086985,Effectiveness of an encecalin standardized extract of Ageratina pichinchensis on the treatment of onychomycosis in patients with diabetes mellitus.,"Ageratina pichinchensis is utilized in traditional medicine for the treatment of dermatomycosis and inflammation. The aim of this study was to evaluate the clinical and mycological effectiveness of the topical administration of an enecalin standardized extract of A. pichinchensis for treating onychomycosis in patients with type 2 diabetes mellitus (DM2). A double blind, randomized, and controlled clinical trial was carried out that included patients with DM2 and who had mild or moderate onychomycosis. Participants were administered topically, for 6 months, a lacquer containing the encecalin standardized extract of A. pichinchensis (experimental group) or 8% ciclopirox (control group). In a large percentage of both, the control group (77.2%) and the experimental group (78.5%), clinical efficacy was detected as a decrease in the number of affected nails and a reduction in the severity of nail involvement. Without exhibiting statistically significant differences between groups, the encecalin standardized extract of A. pichinchensis was clinically and mycologically effective in the treatment of mild and moderate onychomycosis in patients with DM2. The treatment of onychomycosis in patients with DM2 implies a greater challenge, while control of blood glucose levels in these patients, played a very important role in the response of patients to treatment.",2020,"Without exhibiting statistically significant differences between groups, the encecalin standardized extract of A. pichinchensis was clinically and mycologically effective in the treatment of mild and moderate onychomycosis in patients with DM2.","['included patients with DM2 and who had mild or moderate onychomycosis', 'patients with DM2', 'patients with diabetes mellitus', 'patients with type 2 diabetes mellitus (DM2']","['lacquer containing the encecalin standardized extract of A. pichinchensis (experimental group) or 8% ciclopirox (control group', 'enecalin standardized extract of A. pichinchensis', 'encecalin standardized extract of Ageratina pichinchensis']","['number of affected nails', 'severity of nail involvement', 'blood glucose levels', 'clinical efficacy']","[{'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1300562', 'cui_str': 'dm2'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0040261', 'cui_str': 'Tinea Unguium'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}]","[{'cui': 'C0022902', 'cui_str': 'Lacquer'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C2752151', 'cui_str': 'Extract (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0055711', 'cui_str': 'ciclopirox'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1047415', 'cui_str': 'Ageratina'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0027342', 'cui_str': 'Nails'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0205428', 'cui_str': 'Involvements (qualifier value)'}, {'cui': 'C0428554', 'cui_str': 'Blood glucose result - finding'}, {'cui': 'C0087113', 'cui_str': 'Treatment Efficacy'}]",,0.0365675,"Without exhibiting statistically significant differences between groups, the encecalin standardized extract of A. pichinchensis was clinically and mycologically effective in the treatment of mild and moderate onychomycosis in patients with DM2.","[{'ForeName': 'Ofelia', 'Initials': 'O', 'LastName': 'Romero-Cerecero', 'Affiliation': 'Centro de Investigación Biomédica del Sur, Instituto Mexicano del Seguro Social (CIBIS-IMSS), Xochitepec, Mexico.'}, {'ForeName': 'Ana Laura', 'Initials': 'AL', 'LastName': 'Islas-Garduño', 'Affiliation': 'Centro de Investigación Biomédica del Sur, Instituto Mexicano del Seguro Social (CIBIS-IMSS), Xochitepec, Mexico.'}, {'ForeName': 'Alejandro', 'Initials': 'A', 'LastName': 'Zamilpa', 'Affiliation': 'Centro de Investigación Biomédica del Sur, Instituto Mexicano del Seguro Social (CIBIS-IMSS), Xochitepec, Mexico.'}, {'ForeName': 'Jaime', 'Initials': 'J', 'LastName': 'Tortoriello', 'Affiliation': 'Centro de Investigación Biomédica del Sur, Instituto Mexicano del Seguro Social (CIBIS-IMSS), Xochitepec, Mexico.'}]",Phytotherapy research : PTR,['10.1002/ptr.6644'] 3069,31376801,Acute effects of bi-hemispheric transcranial direct current stimulation on the neuromuscular function of patients with chronic stroke: A randomized controlled study.,"BACKGROUND Muscle weakness in patients with chronic stroke is due to neuromuscular disorders such as muscle atrophy, loss of voluntary activation or weak muscle contractile properties which are majored by the imbalance of interhemispheric inhibition following stroke. In patients with chronic stroke, unilateral transcranial direct current stimulation improved the maximal isometric strength of paretic knee extensors, but bilateral transcranial direct current stimulation failed to improve concentric strength. This study aimed to assess if a bilateral current stimulation improves isometric maximal strength, voluntary activation and contractile properties of knee extensors in patients with chronic stroke. METHODS Thirteen patients with chronic stroke and eight young healthy individuals participated in this randomized, simple-blinded, crossover study that included two experimental sessions: one with sham bilateral transcranial direct current stimulation and another with effective bilateral transcranial direct current stimulation (20 min, 2 mA). In the stroke patients, the anode was placed over the primary motor cortex of the affected hemisphere and the cathode over the contralateral primary motor cortex. In healthy participants, the brain side targeted by the anode and the cathode was randomly assigned. In each session, participants performed three assessments of strength, voluntary activation and contractile properties: before, during and after effective/sham bilateral transcranial direct current stimulation. FINDINGS Bilateral transcranial direct current stimulation had no effect on any neuromuscular assessments in both groups (All P values > 0.05, partial eta-squares varied from 0.02 to 0.06). INTERPRETATION A single session of bilateral transcranial direct current stimulation did not compensate muscular weakness of knee extensors in patients with chronic stroke.",2019,A single session of bilateral transcranial direct current stimulation did not compensate muscular weakness of knee extensors in patients with chronic stroke.,"['patients with chronic stroke', 'healthy participants', 'Thirteen patients with chronic stroke and eight young healthy individuals']","['bilateral current stimulation', 'bi-hemispheric transcranial direct current stimulation', 'bilateral transcranial direct current stimulation', 'unilateral transcranial direct current stimulation', 'sham bilateral transcranial direct current stimulation and another with effective bilateral transcranial direct current stimulation (20\u202fmin, 2\u202fmA']","['neuromuscular assessments', 'maximal isometric strength of paretic knee extensors', 'concentric strength', 'isometric maximal strength, voluntary activation and contractile properties of knee extensors']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3536593', 'cui_str': 'Chronic stroke'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C3715149', 'cui_str': '13'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}, {'cui': 'C0205139', 'cui_str': 'Hemispheric (qualifier value)'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0205092', 'cui_str': 'Unilateral (qualifier value)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}]","[{'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0439744', 'cui_str': 'Concentric (qualifier value)'}, {'cui': 'C0439656', 'cui_str': 'Voluntary (qualifier value)'}, {'cui': 'C0871161', 'cui_str': 'Property (attribute)'}]",,0.0589569,A single session of bilateral transcranial direct current stimulation did not compensate muscular weakness of knee extensors in patients with chronic stroke.,"[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Geiger', 'Affiliation': ""AP-HP, Raymond Poincaré Teaching Hospital, Inserm Unit 1179, Team 3: Technologies and Innovative Therapies Applied to Neuromuscular diseases, UVSQ, CIC 805, Physiology-Functional Testing Ward, Garches, France; CIAMS, Univ. Paris-Sud, Université Paris-Saclay, 91405 Orsay Cedex, France; CIAMS, Université d'Orléans, 45067 Orléans, France; Fondation Garches, Garches, France. Electronic address: maxime.geiger@u-psud.fr.""}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Roche', 'Affiliation': 'AP-HP, Raymond Poincaré Teaching Hospital, Inserm Unit 1179, Team 3: Technologies and Innovative Therapies Applied to Neuromuscular diseases, UVSQ, CIC 805, Physiology-Functional Testing Ward, Garches, France; Fondation Garches, Garches, France. Electronic address: roche.nicolas@aphp.fr.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Vlachos', 'Affiliation': 'AP-HP, Raymond Poincaré Teaching Hospital, CIC Inserm Unit 1429, Garches, France. Electronic address: erica.vlachos@aphp.fr.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Cattagni', 'Affiliation': 'AP-HP, Raymond Poincaré Teaching Hospital, Inserm Unit 1179, Team 3: Technologies and Innovative Therapies Applied to Neuromuscular diseases, UVSQ, CIC 805, Physiology-Functional Testing Ward, Garches, France; Fondation Garches, Garches, France; Nantes Université, Mouvement - Interactions - Performance, MIP, EA 4334, F -44000 Nantes, France. Electronic address: thomas.cattagni@univ-nantes.fr.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Zory', 'Affiliation': ""Université Côte d'Azur, LAMHESS, France. Electronic address: raphael.zory@unice.fr.""}]","Clinical biomechanics (Bristol, Avon)",['10.1016/j.clinbiomech.2019.07.022'] 3070,32076558,Randomised comparison of provisional side branch stenting versus a two-stent strategy for treatment of true coronary bifurcation lesions involving a large side branch: the Nordic-Baltic Bifurcation Study IV.,"Background It is still uncertain whether coronary bifurcations with lesions involving a large side branch (SB) should be treated by stenting the main vessel and provisional stenting of the SB (simple) or by routine two-stent techniques (complex). We aimed to compare clinical outcome after treatment of lesions in large bifurcations by simple or complex stent implantation. Methods The study was a randomised, superiority trial. Enrolment required a SB≥2.75 mm, ≥50% diameter stenosis in both vessels, and allowed SB lesion length up to 15 mm. The primary endpoint was a composite of cardiac death, non-procedural myocardial infarction and target lesion revascularisation at 6 months. Two-year clinical follow-up was included in this primary reporting due to lower than expected event rates. Results A total of 450 patients were assigned to simple stenting (n=221) or complex stenting (n=229) in 14 Nordic and Baltic centres. Two-year follow-up was available in 218 (98.6%) and 228 (99.5%) patients, respectively. The primary endpoint of major adverse cardiac events (MACE) at 6 months was 5.5% vs 2.2% (risk differences 3.2%, 95% CI -0.2 to 6.8, p=0.07) and at 2 years 12.9% vs 8.4% (HR 0.63, 95% CI 0.35 to 1.13, p=0.12) after simple versus complex treatment. In the subgroup treated by newer generation drug-eluting stents, MACE was 12.0% vs 5.6% (HR 0.45, 95% CI 0.17 to 1.17, p=0.10) after simple versus complex treatment. Conclusion In the treatment of bifurcation lesions involving a large SB with ostial stenosis, routine two-stent techniques did not improve outcome significantly compared with treatment by the simpler main vessel stenting technique after 2 years. Trial registration number NCT01496638.",2020,"The primary endpoint was a composite of cardiac death, non-procedural myocardial infarction and target lesion revascularisation at 6 months.","['450 patients', 'n=229) in 14 Nordic and Baltic centres', 'true coronary bifurcation lesions involving a large side branch']","['provisional side branch stenting', 'simple stenting (n=221) or complex stenting']","['composite of cardiac death, non-procedural myocardial infarction and target lesion revascularisation at 6\u2009months', 'major adverse cardiac events (MACE', 'SB lesion length']","[{'cui': 'C3844104', 'cui_str': 'Four hundred and fifty'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0205238', 'cui_str': 'True (qualifier value)'}, {'cui': 'C0184906', 'cui_str': 'Bifurcation (procedure)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0205384', 'cui_str': 'Branching (qualifier value)'}]","[{'cui': 'C0205384', 'cui_str': 'Branching (qualifier value)'}, {'cui': 'C0205352', 'cui_str': 'Simple (qualifier value)'}, {'cui': 'C0439855', 'cui_str': 'Complex (qualifier value)'}]","[{'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0376297', 'cui_str': 'Cardiac Death'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0014742', 'cui_str': 'Erythema Multiforme'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0349381', 'cui_str': 'Mace (substance)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}]",450.0,0.153245,"The primary endpoint was a composite of cardiac death, non-procedural myocardial infarction and target lesion revascularisation at 6 months.","[{'ForeName': 'Indulis', 'Initials': 'I', 'LastName': 'Kumsars', 'Affiliation': 'Department of Cardiology, Latvia Center of Cardiology, Paul Stradins Clinical University Hospital, Riga, Latvia.'}, {'ForeName': 'Niels Ramsing', 'Initials': 'NR', 'LastName': 'Holm', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Matti', 'Initials': 'M', 'LastName': 'Niemelä', 'Affiliation': 'Department of Cardiology, Oulu University Hospital, Oulu, Finland.'}, {'ForeName': 'Andrejs', 'Initials': 'A', 'LastName': 'Erglis', 'Affiliation': 'Research Institute of Cardiology and Regenerative Medicine, Latvia Centre of Cardiology, Riga, Latvia.'}, {'ForeName': 'Kari', 'Initials': 'K', 'LastName': 'Kervinen', 'Affiliation': 'Department of Cardiology, Oulu University Hospital, Oulu, Finland.'}, {'ForeName': 'Evald Høj', 'Initials': 'EH', 'LastName': 'Christiansen', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Maeng', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Andis', 'Initials': 'A', 'LastName': 'Dombrovskis', 'Affiliation': 'Department of Cardiology, Latvia Center of Cardiology, Paul Stradins Clinical University Hospital, Riga, Latvia.'}, {'ForeName': 'Vytautas', 'Initials': 'V', 'LastName': 'Abraitis', 'Affiliation': 'Department of Cardiology, Vilnius University Hospital, Vilnius, Lithuania.'}, {'ForeName': 'Aleksandras', 'Initials': 'A', 'LastName': 'Kibarskis', 'Affiliation': 'Department of Cardiology, Vilnius University Hospital, Vilnius, Lithuania.'}, {'ForeName': 'Thor', 'Initials': 'T', 'LastName': 'Trovik', 'Affiliation': 'Department of Cardiology, University of North Norway, Tromsoe, Norway.'}, {'ForeName': 'Gustavs', 'Initials': 'G', 'LastName': 'Latkovskis', 'Affiliation': 'Research Institute of Cardiology and Regenerative Medicine, Latvia Centre of Cardiology, Riga, Latvia.'}, {'ForeName': 'Dace', 'Initials': 'D', 'LastName': 'Sondore', 'Affiliation': 'Department of Cardiology, Latvia Center of Cardiology, Paul Stradins Clinical University Hospital, Riga, Latvia.'}, {'ForeName': 'Inga', 'Initials': 'I', 'LastName': 'Narbute', 'Affiliation': 'Research Institute of Cardiology and Regenerative Medicine, Latvia Centre of Cardiology, Riga, Latvia.'}, {'ForeName': 'Christian Juhl', 'Initials': 'CJ', 'LastName': 'Terkelsen', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Markku', 'Initials': 'M', 'LastName': 'Eskola', 'Affiliation': 'Department of Cardiology, Heart Center, Tampere University Hospital, Tampere, Finland.'}, {'ForeName': 'Hannu', 'Initials': 'H', 'LastName': 'Romppanen', 'Affiliation': 'Department of cardiology, Heart Center, Kuopio University Hospital, Kuopio, Finland.'}, {'ForeName': 'Mika', 'Initials': 'M', 'LastName': 'Laine', 'Affiliation': 'Department of Cardiology, Helsinki University Central Hospital, Helsinki, Finland.'}, {'ForeName': 'Lisette Okkels', 'Initials': 'LO', 'LastName': 'Jensen', 'Affiliation': 'Department of Cardiology, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Mikko', 'Initials': 'M', 'LastName': 'Pietila', 'Affiliation': 'Department of Cardiology, Turku University Hospital, Turku, Finland.'}, {'ForeName': 'Pål', 'Initials': 'P', 'LastName': 'Gunnes', 'Affiliation': 'Heart Center, Sørlandet Hospital, Arendal, Norway.'}, {'ForeName': 'Lasse', 'Initials': 'L', 'LastName': 'Hebsgaard', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Ole', 'Initials': 'O', 'LastName': 'Frobert', 'Affiliation': 'Örebro University, Faculty of Health, Department of Cardiology, Örebro, Sweden.'}, {'ForeName': 'Fredrik', 'Initials': 'F', 'LastName': 'Calais', 'Affiliation': 'Örebro University, Faculty of Health, Department of Cardiology, Örebro, Sweden.'}, {'ForeName': 'Juha', 'Initials': 'J', 'LastName': 'Hartikainen', 'Affiliation': 'Department of cardiology, Heart Center, Kuopio University Hospital, Kuopio, Finland.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Aarøe', 'Affiliation': 'Department of Cardiology, Aalborg University Hospital, Aalborg, Denmark.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Ravkilde', 'Affiliation': 'Department of Cardiology, Aalborg University Hospital, Aalborg, Denmark.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Engstrøm', 'Affiliation': 'Department of Cardiology, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'Terje K', 'Initials': 'TK', 'LastName': 'Steigen', 'Affiliation': 'Department of Cardiology, University Hospital of North Norway, Tromsoe and Cardiovascular Diseases Research Group, UiT The Arctic University of Norway, Tromsø, Norway.'}, {'ForeName': 'Leif', 'Initials': 'L', 'LastName': 'Thuesen', 'Affiliation': 'Department of Cardiology, Aalborg University Hospital, Aalborg, Denmark.'}, {'ForeName': 'Jens F', 'Initials': 'JF', 'LastName': 'Lassen', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Open heart,['10.1136/openhrt-2018-000947'] 3071,32076564,Cost-utility analysis of learning and coping versus standard education in cardiac rehabilitation: a randomised controlled trial with 3 years of follow-up.,"Objectives To enhance adherence to cardiac rehabilitation (CR), a patient education programme called 'learning and coping' (LC-programme) was implemented in three hospitals in Denmark. The aim of this study was to investigate the cost-utility of the LC-programme compared with the standard CR-programme. Methods 825 patients with ischaemic heart disease or heart failure were randomised to the LC-programme or the standard CR-programme and were followed for 3 years.A societal cost perspective was applied and quality-adjusted life years (QALY) were based on SF-6D measurements. Multiple imputation technique was used to handle missing data on the SF-6D. The statistical analyses were based on means and bootstrapped SEs. Regression framework was employed to estimate the net benefit and to illustrate cost-effectiveness acceptability curves. Results No statistically significant differences were found between the two programmes in total societal costs (4353 Euros; 95% CI -3828 to 12 533) or in QALY (-0.006; 95% CI -0.053 to 0.042). At a threshold of 40 000 Euros, the LC-programme was found to be cost-effective at 15% probability; however, for patients with heart failure, due to increased cost savings, the probability of cost-effectiveness increased to 91%. Conclusions While the LC-programme did not appear to be cost-effective in CR, important heterogeneity was noted for subgroups of patients. The LC-programme was demonstrated to increase adherence to the rehabilitation programme and to be cost-effective among patients with heart failure. However, further research is needed to study the dynamic value of heterogeneity due to the small sample size in this subgroup.",2020,The LC-programme was demonstrated to increase adherence to the rehabilitation programme and to be cost-effective among patients with heart failure.,"['825 patients with ischaemic heart disease or heart failure', 'patients with heart failure', 'cardiac rehabilitation']","['learning and coping versus standard education', 'LC-programme or the standard CR-programme', ""cardiac rehabilitation (CR), a patient education programme called 'learning and coping' (LC-programme"", 'LC-programme']","['total societal costs', 'cost savings, the probability of cost-effectiveness', 'cost-utility']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0151744', 'cui_str': 'Ischemic Heart Disease'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0700431', 'cui_str': 'Cardiovascular Rehabilitation'}]","[{'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0700431', 'cui_str': 'Cardiovascular Rehabilitation'}, {'cui': 'C0030688', 'cui_str': 'Education of Patients'}, {'cui': 'C1720420', 'cui_str': 'Call'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0085550', 'cui_str': 'Saving, Cost'}, {'cui': 'C0033204', 'cui_str': 'Probability'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}]",825.0,0.0314959,The LC-programme was demonstrated to increase adherence to the rehabilitation programme and to be cost-effective among patients with heart failure.,"[{'ForeName': 'Nasrin', 'Initials': 'N', 'LastName': 'Tayyari Dehbarez', 'Affiliation': 'DEFACTUM, Aarhus N, Denmark.'}, {'ForeName': 'Camilla', 'Initials': 'C', 'LastName': 'Palmhøj Nielsen', 'Affiliation': 'DEFACTUM, Aarhus N, Denmark.'}, {'ForeName': 'Bettine Wulff', 'Initials': 'BW', 'LastName': 'Risør', 'Affiliation': 'DEFACTUM, Aarhus N, Denmark.'}, {'ForeName': 'Claus', 'Initials': 'C', 'LastName': 'Vinther Nielsen', 'Affiliation': 'DEFACTUM, Aarhus N, Denmark.'}, {'ForeName': 'Vibeke', 'Initials': 'V', 'LastName': 'Lynggaard', 'Affiliation': 'Department of Cardiology, Regional Hospital West Jutland, Herning, Denmark.'}]",Open heart,['10.1136/openhrt-2019-001184'] 3072,32076567,Performing percutaneous coronary interventions with predilatation using non-compliant balloons at high-pressure versus conventional semi-compliant balloons: insights from two randomised studies using optical coherence tomography.,"Introduction Stent underexpansion is a predictor of in-stent-restenosis and stent thrombosis. Semi-compliant balloons (SCBs) are generally used for lesion preparation. It remains unknown whether routine predilatation using non-compliant balloons (NCBs) improves stent expansion in ordinary coronary lesions. Methods The PREdilatation by high-pressure NC balloon catheter for better vessel preparation and Optimal lesion preparation with non-compliant balloons for the implantation of bioresorbable vascular scaffolds studies randomised patients presenting with stable coronary artery disease or non-ST-elevation myocardial infarction requiring stent implantation to lesion preparation using NCBs versus SCBs. Stent expansion index (SEI-minimal luminal area/mean luminal area on optical coherence tomography) and periprocedural complications were compared. Results We enrolled 104 patients: 53 patients (54 lesions) vs 51 patients (56 lesions) to the NCB and SCB groups, respectively. Predilatation pressure was higher in the NCB group (24±7 atmospheres (atm) vs 14±3 atm, p<0.0001). Postdilatation using NCBs was performed in 41 (76%) lesions vs 46 (82%) lesions pretreated with NCBs versus SCBs (p=0.57). Similar pressures were used for postdilatation with NCB in both groups (23±8 atm vs 23±9 atm, p=0.65). SEI after stent implantation was 0.88±0.13 in the NCB vs 0.85±0.14 in the SCB group (p=0.18). After postdilatation, SEI increased to 0.94±0.13 in the NCB group vs 0.88±0.13 in the SCB group (p=0.02). No relevant complications occurred. Conclusions In simple coronary lesions, predilatation/postdilatation with NCBs at high pressures appears to result in better scaffold and stent expansion. Using SCBs only for predilatation might lead to inadequate stent expansion and postdilatation with NCBs might only partially correct this. Predilatation and postdilatation using NCBs at high pressure is safe. Trial registration number ClinicalTrials.gov no. NCT03518645.",2020,"No relevant complications occurred. ","['patients presenting with stable coronary artery disease or non-ST-elevation myocardial infarction requiring stent implantation to lesion preparation using NCBs versus SCBs', 'We enrolled 104 patients: 53 patients (54 lesions) vs 51 patients (56 lesions) to the NCB and SCB groups, respectively']","['optical coherence tomography', 'PREdilatation by high-pressure NC balloon catheter', 'percutaneous coronary interventions with predilatation using non-compliant balloons at high-pressure versus conventional semi-compliant balloons', 'NCB', 'Semi-compliant balloons (SCBs']","['SEI', 'Stent expansion index (SEI-minimal luminal area/mean luminal area on optical coherence tomography) and periprocedural complications', 'Predilatation pressure']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}, {'cui': 'C4255010', 'cui_str': 'Non-ST-Elevation Myocardial Infarction'}, {'cui': 'C0038257', 'cui_str': 'Stents'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C4517527', 'cui_str': '104'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0920367', 'cui_str': 'Tomography, Optical Coherence'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0441127', 'cui_str': 'Balloon dilatation catheter (physical object)'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}, {'cui': 'C0457432', 'cui_str': 'Non-compliant (qualifier value)'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft (physical object)'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0566588', 'cui_str': 'Compliant (qualifier value)'}]","[{'cui': 'C0038257', 'cui_str': 'Stents'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0547040', 'cui_str': 'Minimal (qualifier value)'}, {'cui': 'C0699493', 'cui_str': 'Luminal'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0920367', 'cui_str': 'Tomography, Optical Coherence'}, {'cui': 'C1141861', 'cui_str': 'Periprocedural complication'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}]",104.0,0.0911478,"No relevant complications occurred. ","[{'ForeName': 'Florim', 'Initials': 'F', 'LastName': 'Cuculi', 'Affiliation': 'Cardiology Division, Heart Center, Luzerner Kantonsspital, Luzern, Switzerland.'}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Bossard', 'Affiliation': 'Cardiology Division, Heart Center, Luzerner Kantonsspital, Luzern, Switzerland.'}, {'ForeName': 'Wojciech', 'Initials': 'W', 'LastName': 'Zasada', 'Affiliation': 'Krakow Cardiovascular Research Institute (KCRI), Krakow, Poland.'}, {'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Moccetti', 'Affiliation': 'Cardiology Division, Heart Center, Luzerner Kantonsspital, Luzern, Switzerland.'}, {'ForeName': 'Michiel', 'Initials': 'M', 'LastName': 'Voskuil', 'Affiliation': 'Department of Cardiology, UMC Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'Mathias', 'Initials': 'M', 'LastName': 'Wolfrum', 'Affiliation': 'Cardiology Division, Heart Center, Luzerner Kantonsspital, Luzern, Switzerland.'}, {'ForeName': 'Krzysztof Piotr', 'Initials': 'KP', 'LastName': 'Malinowski', 'Affiliation': 'Institute of Public Health, Faculty of Health Sciences, Jagiellonian University Medical College, Kraków, Poland.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Toggweiler', 'Affiliation': 'Cardiology Division, Heart Center, Luzerner Kantonsspital, Luzern, Switzerland.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Kobza', 'Affiliation': 'Cardiology Division, Heart Center, Luzerner Kantonsspital, Luzern, Switzerland.'}]",Open heart,['10.1136/openhrt-2019-001204'] 3073,32085836,"Safety and efficacy of GABA A α5 antagonist S44819 in patients with ischaemic stroke: a multicentre, double-blind, randomised, placebo-controlled trial.","BACKGROUND S44819, a selective GABA A α5 receptor antagonist, reduces tonic post-ischaemic inhibition of the peri-infarct cortex. S44819 improved stroke recovery in rodents and increased cortical excitability in a transcranial magnetic stimulation study in healthy volunteers. The Randomized Efficacy and Safety Trial of Oral GABA A α5 antagonist S44819 after Recent ischemic Event (RESTORE BRAIN) aimed to evaluate the safety and efficacy of S44819 for enhancing clinical recovery of patients with ischaemic stroke. METHODS RESTORE BRAIN was an international, randomised, double-blind, parallel-group, placebo-controlled, multicentre phase 2 trial that evaluated the safety and efficacy of oral S44189 in patients with recent ischaemic stroke. The study was done in specialised stroke units in 92 actively recruiting centres in 14 countries: ten were European countries (Belgium, Czech Republic, France, Germany, Hungary, Italy, Netherlands, Poland, Spain, and the UK) and four were non-European countries (Australia, Brazil, Canada, and South Korea). Patients aged 18-85 years with acute ischaemic stroke involving cerebral cortex (National Institute of Health Stroke Scale [NIHSS] score 7-20) without previous disability were eligible for inclusion. Participants were randomly assigned to receive 150 mg S44819 twice a day, 300 mg S44819 twice a day, or placebo twice a day by a balanced, non-adaptive randomisation method with a 1:1:1 ratio. Treatment randomisation and allocation were centralised via the interactive web response system using computer-generated random sequences with a block size of 3. Blinding of treatment was achieved by identical appearance and taste of all sachets. Patients, investigators and individuals involved in the analysis of the trial were masked to group assignment. The primary endpoint was the modified Rankin Scale (mRS) score 90 days from onset of treatment, evaluated by shift analysis (predefined main analysis) or by dichotomised analyses using 0-1 versus 2-6 and 0-2 versus 3-6 cutoffs (predefined secondary analysis). Secondary endpoints were the effects of S44819 on the NIHSS and Montreal Cognitive Assessment (MoCA) scores, time needed to complete parts A and B of the Trail Making Test, and the Barthel index. Efficacy analyses were done on all patients who received at least one dose of treatment and had at least one mRS score taken after day 5 (specifically, on or after day 30). Safety was compared across treatment groups for all patients who received at least one dose of treatment. The study was registered at ClinicalTrials.gov, NCT02877615. FINDINGS Between Dec 19, 2016, and Nov 16, 2018, 585 patients were enrolled in the study. Of these, 197 (34%) were randomly assigned to receive 150 mg S44819 twice a day, 195 (33%) to receive 300 mg S44819 twice a day, and 193 (33%) to receive placebo twice a day. 189 (96%) of 197 patients in the 150 mg S44819 group, 188 (96%) of 195 patients in the 300 mg S44819 group, and 191 (99%) patients in the placebo group received at least one dose of treatment and had at least one mRS score taken after day 5, and were included in efficacy analyses. 195 (99%) of 197 patients in the 150 mg S44819 group, 194 (99%) of 195 patients in the 300 mg S44819 group, and 193 (100%) patients in the placebo group received at least one dose of treatment, and were included in safety analyses. The primary endpoint of mRS at day 90 did not differ between each of the two S44819 groups and the placebo group (OR 0·91 [95% CI 0·64-1·31]; p=0·80 for 150 mg S44819 compared with placebo and OR 1·17 [95% CI 0·81-1·67]; p=0·80 for 300 mg S44819 compared with placebo). Likewise, dichotomised mRS scores at day 90 (mRS 0-2 vs 3-6 or mRS 0-1 vs 2-6) did not differ between groups. Secondary endpoints did not reveal any significant group differences. The median NIHSS score at day 90 did not differ between groups (4 [IQR 2-8] in 150 mg S44819 group, 4 [2-7] in 300 mg S44819 group, and 4 [2-6] in placebo group), nor did the number of patients at day 90 with an NIHSS score of up to 5 (95 [61%] of 156 in 150 mg S44819 group, 106 [66%] of 161 in 300 mg S44819 group, and 104 [66%] of 157 in placebo group) versus more than 5 (61 [39%] in 150 mg S44819 group, 55 [34%] in 300 mg S44819 group, and 53 [34%] in placebo group). Likewise, the median MoCA score (22·0 [IQR 17·0-26·0] in 150 mg S44819 group, 23·0 [19·0-26·5] in 300 mg S44819 group, and 22·0 [17·0-26·0] in placebo group), time needed to complete parts A (50 s [IQR 42-68] in 150 mg S44819 group, 49 s [36-63] in 300 mg S44819 group, and 50 s [38-68] in placebo group) and B (107 s [81-144] in 150 mg S44819 group, 121 s [76-159] in 300 mg S44819 group, and 130 s [86-175] in placebo group) of the Trail Making Test, and the Barthel index (90 [IQR 60-100] in 150 mg S44819 group, 90 [70-100] in 300 mg S44819 group, and 90 [70-100] in placebo group) were similar in all groups. Number and type of adverse events were similar between the three groups. There were no drug-related adverse events and no drug-related deaths. INTERPRETATION There was no evidence that S44819 improved clinical outcome in patients after ischaemic stroke, and thus S44819 cannot be recommended for stroke therapy. The concept of tonic inhibition after stroke should be re-evaluated in humans. FUNDING Servier.",2020,"The median NIHSS score at day 90 did not differ between groups (4 [IQR 2-8] in 150 mg S44819 group, 4 [2-7] in 300 mg S44819 group, and 4 [2-6] in placebo group), nor did the number of patients at day 90 with an NIHSS score of up to 5 (95 [61%] of 156 in 150 mg S44819 group, 106 [66%] of 161 in 300 mg S44819 group, and 104 [66%] of 157 in placebo group) versus more than 5 (61 [39%] in 150 mg S44819 group, 55 [34%] in 300 mg S44819 group, and 53 [34%] in placebo group).","['healthy volunteers', 'specialised stroke units in 92 actively recruiting centres in 14 countries: ten were European countries (Belgium, Czech Republic, France, Germany, Hungary, Italy, Netherlands, Poland, Spain, and the UK) and four were non-European countries (Australia, Brazil, Canada, and South Korea', '300 mg S44819 group, and 22·0', 'patients with ischaemic stroke', 'Between Dec 19, 2016, and Nov 16, 2018, 585 patients were enrolled in the study', 'patients with recent ischaemic stroke', 'Patients aged 18-85 years with acute ischaemic stroke involving cerebral cortex (National Institute of Health Stroke Scale [NIHSS] score 7-20) without previous disability were eligible for inclusion']","['S44819', 'oral S44189', 'Oral GABA A', 'placebo', 'GABA A', 'α5 antagonist S44819']","['dichotomised mRS scores', 'Number and type of adverse events', 'effects of S44819 on the NIHSS and Montreal Cognitive Assessment (MoCA) scores, time needed to complete parts A and B of the Trail Making Test, and the Barthel index', 'median MoCA score', 'mRS', 'stroke recovery', 'Safety', 'safety and efficacy', 'time needed to complete parts A', 'cortical excitability', 'modified Rankin Scale (mRS) score', 'median NIHSS score']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0587502', 'cui_str': 'Stroke unit (environment)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0454713', 'cui_str': 'European country (geographic location)'}, {'cui': 'C0004950', 'cui_str': 'Belgium'}, {'cui': 'C0206578', 'cui_str': 'Czech Republic'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0020174', 'cui_str': 'Hungary'}, {'cui': 'C0022277', 'cui_str': 'Italy'}, {'cui': 'C0032356', 'cui_str': 'Republic of Poland'}, {'cui': 'C0037747', 'cui_str': 'Spain'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C0006137', 'cui_str': 'Brazil'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0022773', 'cui_str': 'South Korea'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C4705846', 'cui_str': 'S44819'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0948008', 'cui_str': 'Ischemic stroke (disorder)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C0007776', 'cui_str': 'Cortical Plate'}, {'cui': 'C3472498', 'cui_str': 'National Institutes of Health stroke scale score (observable entity)'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}]","[{'cui': 'C4705846', 'cui_str': 'S44819'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0016904', 'cui_str': 'gamma-Aminobutyric Acid'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0243076', 'cui_str': 'antagonists'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C4705846', 'cui_str': 'S44819'}, {'cui': 'C4721272', 'cui_str': 'Montreal cognitive assessment score'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0449719', 'cui_str': 'Part (attribute)'}, {'cui': 'C0040604', 'cui_str': 'Trail Making Test'}, {'cui': 'C0451019', 'cui_str': 'Barthel index (assessment scale)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C4277734', 'cui_str': 'Cortical Excitability'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}]",585.0,0.542813,"The median NIHSS score at day 90 did not differ between groups (4 [IQR 2-8] in 150 mg S44819 group, 4 [2-7] in 300 mg S44819 group, and 4 [2-6] in placebo group), nor did the number of patients at day 90 with an NIHSS score of up to 5 (95 [61%] of 156 in 150 mg S44819 group, 106 [66%] of 161 in 300 mg S44819 group, and 104 [66%] of 157 in placebo group) versus more than 5 (61 [39%] in 150 mg S44819 group, 55 [34%] in 300 mg S44819 group, and 53 [34%] in placebo group).","[{'ForeName': 'Hugues', 'Initials': 'H', 'LastName': 'Chabriat', 'Affiliation': 'Department of Neurology, Lariboisière Hospital, Paris Diderot University and INSERM U1141, Paris, France.'}, {'ForeName': 'Claudio L', 'Initials': 'CL', 'LastName': 'Bassetti', 'Affiliation': 'Department of Neurology, University Hospital Berne, Berne, Switzerland.'}, {'ForeName': 'Ute', 'Initials': 'U', 'LastName': 'Marx', 'Affiliation': 'Institut de Recherches Internationales Servier (IRIS), Suresnes, France.'}, {'ForeName': 'Marie-Laure', 'Initials': 'ML', 'LastName': 'Audoli-Inthavong', 'Affiliation': 'Institut de Recherches Internationales Servier (IRIS), Suresnes, France.'}, {'ForeName': 'Aurore', 'Initials': 'A', 'LastName': 'Sors', 'Affiliation': 'Institut de Recherches Internationales Servier (IRIS), Suresnes, France.'}, {'ForeName': 'Estelle', 'Initials': 'E', 'LastName': 'Lambert', 'Affiliation': 'Institut de Recherches Internationales Servier (IRIS), Suresnes, France.'}, {'ForeName': 'Marine', 'Initials': 'M', 'LastName': 'Wattez', 'Affiliation': 'Institut de Recherches Internationales Servier (IRIS), Suresnes, France.'}, {'ForeName': 'Dirk M', 'Initials': 'DM', 'LastName': 'Hermann', 'Affiliation': 'Department of Neurology, University Hospital Essen, University of Duisburg-Essen, Essen, Germany. Electronic address: dirk.hermann@uk-essen.de.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Neurology,['10.1016/S1474-4422(20)30004-1'] 3074,32082008,Prevalence of Cesarean Section and Analysis of Neonatal Apgar Score and the Mean Time of Second Phase of Labor in Pregnant Women.,"Introduction The labor pain is probably the most severe pain a mother experiences in her lifetime and is usually severe and prolonged in women with pregnancy. Aim To evaluate the effects of labor epidural and spinal analgesia on the incidence of cesarean section in painless delivery. Methods This randomized clinical trial was conducted on pregnant women aged 37-42 weeks of pregnancy. Female candidates for painless labor were divided into two groups: Epidural Analgesia (EA) and Spinal Analgesia (SA). Patients in the labor epidural group underwent analgesia using marcaine and fentanyl and after fully assuring the normal hemodynamic status of the mother and fetal hearth rate (FHR), labor spinal analgesia was used for other group. Results The average age of mothers was 27.5 years, their mean gestational age was 39 weeks and their mean weight was determined to be 72 kg. Frequency of cesarean delivery in mothers was found as 12.9%. Significantly, the incidence of cesarean section in the labor epidural analgesia group was higher than the labor spinal analgesia group (P = 0.02). In addition, the mean second phase of delivery in the labor epidural analgesia group was significantly higher than the labor spinal analgesia group (P = 0.03). There was no significant in 1st and 5th min Apgar scores between groups in infants (8.6 and 9.6, respectively). Conclusion Labor epidural analgesia and labor spinal analgesia result in a significant reduction in pain due to normal delivery. Due to the similarity of Apgar and arterial blood gas (ABG) in neonates, labor epidural analgesia may serve as an alternative in childbirth delivery.",2019,"There was no significant in 1st and 5th min Apgar scores between groups in infants (8.6 and 9.6, respectively). ","['pregnant women aged 37-42 weeks of pregnancy', 'Pregnant Women', 'average age of mothers was 27.5 years, their mean gestational age was 39 weeks and their mean weight was determined to be 72 kg', 'Female candidates for painless labor', 'painless delivery']","['labor epidural and spinal analgesia', 'Epidural Analgesia (EA) and Spinal Analgesia (SA', 'analgesia using marcaine and fentanyl and after fully assuring the normal hemodynamic status of the mother and fetal hearth rate (FHR), labor spinal analgesia was used for other group']","['Apgar and arterial blood gas (ABG', 'Frequency of cesarean delivery', '1st and 5th min Apgar scores', 'incidence of cesarean section', 'Prevalence of Cesarean Section and Analysis of Neonatal Apgar Score and the Mean Time of Second Phase of Labor', 'pain', 'mean second phase of delivery']","[{'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C4517674', 'cui_str': '27.5'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0017504', 'cui_str': 'Fetal Maturity, Chronologic'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0234226', 'cui_str': 'Painless (qualifier value)'}, {'cui': 'C0022864', 'cui_str': 'Labor, Obstetric'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}]","[{'cui': 'C0022864', 'cui_str': 'Labor, Obstetric'}, {'cui': 'C1963862', 'cui_str': 'Spinal analgesia'}, {'cui': 'C0002769', 'cui_str': 'Analgesia, Epidural'}, {'cui': 'C3202977', 'cui_str': 'Analgesia'}, {'cui': 'C2945665', 'cui_str': 'Marcaine'}, {'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0205307', 'cui_str': 'Normal (qualifier value)'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0150411', 'cui_str': 'Blood gases, arterial measurement (procedure)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C1384674', 'cui_str': 'Deliveries by cesarean (finding)'}, {'cui': 'C0205435', 'cui_str': 'First (qualifier value)'}, {'cui': 'C0205439', 'cui_str': 'Fifth (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0003533', 'cui_str': 'Apgar Score'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0007876', 'cui_str': 'C-Section (OB)'}, {'cui': 'C0220900', 'cui_str': 'prevalence'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C2939425', 'cui_str': 'Neonatal (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0022864', 'cui_str': 'Labor, Obstetric'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}]",,0.0263114,"There was no significant in 1st and 5th min Apgar scores between groups in infants (8.6 and 9.6, respectively). ","[{'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Shokrpour', 'Affiliation': 'Department of Gynecology, Arak University of Medical Sciences, Arak, Iran.'}, {'ForeName': 'Parisa Pour Seyed', 'Initials': 'PPS', 'LastName': 'Reza', 'Affiliation': 'Department of Gynecology, Arak University of Medical Sciences, Arak, Iran.'}, {'ForeName': 'Mehrzad', 'Initials': 'M', 'LastName': 'Sharifi', 'Affiliation': 'Department of Surgery, Arak University of Medical Sciences, Arak, Iran.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Kamali', 'Affiliation': 'Department of Anesthesiology and Critical Care, Arak University of Medical Sciences, Arak, Iran.'}]","Medical archives (Sarajevo, Bosnia and Herzegovina)",['10.5455/medarh.2019.73.399-403'] 3075,32080013,"Efficacy of a Standalone Microporous Ceramic Versus Autograft in Instrumented Posterolateral Spinal Fusion: A Multicenter, Randomized, Intrapatient Controlled, Noninferiority Trial.","STUDY DESIGN in the rest of the article written as patient- and observer-blinded, multicenter, randomized, intrapatient controlled, noninferiority trial. OBJECTIVE The aim of this study was to determine noninferiority of a biphasic calcium-phosphate (AttraX® Putty) as a bone graft substitute for autograft in instrumented posterolateral fusion (PLF). SUMMARY OF BACKGROUND DATA Spinal fusion with autologous bone graft is a frequently performed surgical treatment. Several drawbacks of autografting have driven the development of numerous alternatives including synthetic ceramics. However, clinical evidence for the standalone use of these materials is limited. METHODS This study included 100 nontraumatic adults who underwent a primary, single- or multilevel, thoracolumbar, instrumented PLF. After instrumentation and preparation for grafting, the randomized allocation side of AttraX® Putty was disclosed. Autograft was applied to the contralateral side of the fusion trajectory, so each patient served as his/her own control. For the primary efficacy outcome, PLF was assessed at 1-year follow-up on computed tomography scans. Each segment and side was scored as fused, doubtful fusion, or nonunion. After correction for multilevel fusions, resulting in a single score per side, the fusion performance of AttraX Putty was tested with a noninferiority margin of 15% using a 90% confidence interval (CI). RESULTS There were 49 males and 51 females with a mean age of 55.4 ± 12.0 (range 27-79) years. Two-third of the patients underwent a single-level fusion and 62% an additional interbody fusion procedure. The primary analysis was based on 87 patients, including 146 instrumented segments. The fusion rate of AttraX Putty was 55% versus 52% at the autograft side, with an overall fusion rate of 71%. The 90% CI around the difference in fusion performance excluded the noninferiority margin (difference = 2.3%, 90% CI = -9.1% to +13.7%). CONCLUSION The results of this noninferiority trial support the use of AttraX Putty as a standalone bone graft substitute for autograft in instrumented thoracolumbar PLF. LEVEL OF EVIDENCE 1.",2020,"The 90% CI around the difference in fusion performance excluded the non-inferiority margin (difference = 2.3%, 90% CI = -9.1% to +13.7%). ","['87 patients, including 146 instrumented segments', '49 males and 51 females with a mean age of 55.4\u200a±\u200a12.0 (range 27-79) years', '100 non-traumatic adults who underwent a primary, single- or multilevel, thoracolumbar, instrumented PLF']","['biphasic calcium-phosphate (AttraX® Putty', 'Standalone Microporous Ceramic vs. Autograft', 'AttraX® Putty']","['fusion rate of AttraX® Putty', 'fusion performance excluded the non-inferiority margin', 'PLF']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C4551823', 'cui_str': 'instruments'}, {'cui': 'C0441635', 'cui_str': 'Segment (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0332663', 'cui_str': 'Traumatic (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0450219', 'cui_str': 'Thoracolumbar (qualifier value)'}]","[{'cui': 'C0210087', 'cui_str': 'biphasic calcium phosphate'}, {'cui': 'C0007742', 'cui_str': 'Ceramics'}, {'cui': 'C0040736', 'cui_str': 'Autotransplantation'}]","[{'cui': 'C1293131', 'cui_str': 'Fusion procedure (procedure)'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0205284', 'cui_str': 'Marginal (qualifier value)'}]",100.0,0.253585,"The 90% CI around the difference in fusion performance excluded the non-inferiority margin (difference = 2.3%, 90% CI = -9.1% to +13.7%). ","[{'ForeName': 'A Mechteld', 'Initials': 'AM', 'LastName': 'Lehr', 'Affiliation': 'Department of Orthopaedic Surgery, University Medical Center Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'F Cumhur', 'Initials': 'FC', 'LastName': 'Oner', 'Affiliation': 'Department of Orthopaedic Surgery, University Medical Center Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'Diyar', 'Initials': 'D', 'LastName': 'Delawi', 'Affiliation': 'Department of Orthopaedic Surgery, St. Antonius Hospital, Utrecht, The Netherlands.'}, {'ForeName': 'Rebecca K', 'Initials': 'RK', 'LastName': 'Stellato', 'Affiliation': 'Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'Eric A', 'Initials': 'EA', 'LastName': 'Hoebink', 'Affiliation': 'Department of Orthopaedic Surgery, Amphia Hospital, Breda, The Netherlands.'}, {'ForeName': 'Diederik H R', 'Initials': 'DHR', 'LastName': 'Kempen', 'Affiliation': 'Department of Orthopaedic Surgery, OLVG, Amsterdam, The Netherlands.'}, {'ForeName': 'Job L C', 'Initials': 'JLC', 'LastName': 'van Susante', 'Affiliation': 'Department of Orthopaedic Surgery, Rijnstate Hospital, Arnhem, The Netherlands.'}, {'ForeName': 'René M', 'Initials': 'RM', 'LastName': 'Castelein', 'Affiliation': 'Department of Orthopaedic Surgery, University Medical Center Utrecht, Utrecht, The Netherlands.'}, {'ForeName': 'Moyo C', 'Initials': 'MC', 'LastName': 'Kruyt', 'Affiliation': 'Department of Orthopaedic Surgery, University Medical Center Utrecht, Utrecht, The Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Spine,['10.1097/BRS.0000000000003440'] 3076,32087175,"Negative pressure wound therapy versus standard treatment in patients with acute conflict-related extremity wounds: a pragmatic, multisite, randomised controlled trial.","BACKGROUND In armed conflict, injuries among civilians are usually complex and commonly affect the extremities. Negative pressure wound therapy (NPWT) is an alternative to standard treatment of acute conflict-related extremity wounds. We aimed to compare the safety and effectiveness of NPWT with that of standard treatment. METHODS In this pragmatic, randomised, controlled superiority trial done at two civilian hospitals in Jordan and Iraq, we recruited patients aged 18 years or older, presenting with a conflict-related extremity wound within 72 h after injury. Participants were assigned (1:1) to receive either NPWT or standard treatment. We used a predefined, computer-generated randomisation list with three block sizes. Participants and their treating physicians were not masked to treatment allocation. The primary endpoint was wound closure by day 5. The coprimary endpoint was net clinical benefit, defined as a composite of wound closure by day 5 and freedom from any bleeding, wound infection, sepsis, or amputation of the index limb. Analysis was by intention to treat. The trial is registered with ClinicalTrials.gov, number NCT02444598, and is closed to accrual. FINDINGS Between June 9, 2015, and Oct 24, 2018, 174 patients were randomly assigned to either the NPWT group (n=88) or the standard treatment group (n=86). Five patients in the NPWT group and four in the standard treatment group were excluded from the intention-to-treat analysis. By day 5, 41 (49%) of 83 participants in the NPWT group and 49 (60%) of 82 participants in the standard treatment group had closed wounds, with an absolute difference of 10 percentage points (95% CI -5 to 25, p=0·212; risk ratio [RR] 0·83, 95% CI 0·62 to 1·09). Net clinical benefit was seen in 33 (41%) of 81 participants in the NPWT group and 34 (44%) of 78 participants in the standard treatment group, with an absolute difference of 3 percentage points (95% CI -12 to 18, p=0·750; RR 0·93, 95% CI 0·65 to 1·35). There was one in-hospital death in the standard treatment group and none in the NPWT group. The proportion of participants with sepsis, bleeding leading to blood transfusion, and limb amputation did not differ between groups. INTERPRETATION NPWT did not yield superior clinical outcomes compared with standard treatment for acute conflict-related extremity wounds. The results of this study not only question the use of NPWT, but also question the tendency for new and costly treatments to be introduced into resource-limited conflict settings without supporting evidence for their effectiveness. This study shows that high-quality, randomised trials in challenging settings are possible, and our findings support the call for further research that will generate context-specific evidence. FUNDING The Stockholm County Council, the Swedish National Board of Health and Welfare, and Médecins Sans Frontières.",2020,"The proportion of participants with sepsis, bleeding leading to blood transfusion, and limb amputation did not differ between groups. ","['Between June 9, 2015, and Oct 24, 2018', 'patients with acute conflict-related extremity wounds', '174 patients', 'two civilian hospitals in Jordan and Iraq, we recruited patients aged 18 years or older, presenting with a conflict-related extremity wound within 72 h after injury']","['NPWT or standard treatment', 'Negative pressure wound therapy versus standard treatment', 'NPWT', 'Negative pressure wound therapy (NPWT']","['Net clinical benefit', 'net clinical benefit, defined as a composite of wound closure by day 5 and freedom from any bleeding, wound infection, sepsis, or amputation of the index limb', 'hospital death', 'wound closure by day 5', 'proportion of participants with sepsis, bleeding leading to blood transfusion, and limb amputation', 'closed wounds', 'safety and effectiveness']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0009671', 'cui_str': 'Conflict'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0015385', 'cui_str': 'Limbs'}, {'cui': 'C0021501', 'cui_str': 'wounds'}, {'cui': 'C4517604', 'cui_str': 'One hundred and seventy-four'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0022418', 'cui_str': 'Jordan'}, {'cui': 'C0022066', 'cui_str': 'Republic of Iraq'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0332285', 'cui_str': 'In (attribute)'}, {'cui': 'C0231290', 'cui_str': 'Status post (contextual qualifier) (qualifier value)'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1956078', 'cui_str': 'Topical Negative-Pressure Therapy'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0450015', 'cui_str': 'Method of wound closure (attribute)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0016694', 'cui_str': 'Liberty'}, {'cui': 'C0043241', 'cui_str': 'Wound Infection'}, {'cui': 'C0243026', 'cui_str': 'Sepsis'}, {'cui': 'C0002688', 'cui_str': 'Amputation'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0015385', 'cui_str': 'Limbs'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0023175', 'cui_str': 'Lead'}, {'cui': 'C1273858', 'cui_str': 'Transfusion Medicine'}, {'cui': 'C0002689', 'cui_str': 'Amputation of limb'}, {'cui': 'C0679319', 'cui_str': 'Closed wound (disorder)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1280519', 'cui_str': 'Effectiveness (qualifier value)'}]",174.0,0.178865,"The proportion of participants with sepsis, bleeding leading to blood transfusion, and limb amputation did not differ between groups. ","[{'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Älgå', 'Affiliation': 'Department of Clinical Science and Education, Södersjukhuset, Karolinska Institutet, Stockholm, Sweden; Department of Global Public Health, Karolinska Institutet, Stockholm, Sweden. Electronic address: andreas.alga@ki.se.'}, {'ForeName': 'Rawand', 'Initials': 'R', 'LastName': 'Haweizy', 'Affiliation': 'College of Medicine, Hawler Medical University, Erbil, Iraq.'}, {'ForeName': 'Khaldoon', 'Initials': 'K', 'LastName': 'Bashaireh', 'Affiliation': 'Department of Special Surgery, Jordan University of Science and Technology, Irbid, Jordan.'}, {'ForeName': 'Sidney', 'Initials': 'S', 'LastName': 'Wong', 'Affiliation': 'Médecins Sans Frontières, Operational Centre Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Kalle Conneryd', 'Initials': 'KC', 'LastName': 'Lundgren', 'Affiliation': 'Department of Molecular Medicine and Surgery, Karolinska Institutet, Karolinska University Hospital, Stockholm, Sweden.'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'von Schreeb', 'Affiliation': 'Department of Global Public Health, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'Malmstedt', 'Affiliation': 'Department of Clinical Science and Education, Södersjukhuset, Karolinska Institutet, Stockholm, Sweden.'}]",The Lancet. Global health,['10.1016/S2214-109X(19)30547-9'] 3077,32045493,"Safety, tolerability, pharmacokinetics and pharmacodynamics of the anti-CD38 cytolytic antibody TAK-079 in healthy subjects.","AIMS This investigation characterised tolerability, pharmacokinetics and pharmacodynamics of the anti-CD38 antibody TAK-079. METHODS A randomised, double-blind, placebo-controlled trial of a single intravenous (i.v.) infusion or subcutaneous (s.c.) injection of TAK-079 at escalating doses in healthy subjects (n = 74), who were followed for 92 days postexposure. RESULTS TAK-079 was well tolerated. All adverse events were mild or moderate. There were no withdrawals, infusion, or injection site reactions over the tested i.v. and s.c. doses up to 0.06 and 0.6 mg kg -1 , respectively. At higher doses, transient cytokine level increases, following i.v. administration, coincided with reduction in CD38-expressing cells; clinical symptoms included mild pyrexia, headache, and postural hypotension. Following an i.v. infusion of 0.06 mg kg -1 TAK-079, maximum observed serum concentration (C max ) was 100.4 (%CV: 52) ng mL -1 , time to C max was the end of infusion and natural killer (NK_ cells were reduced 93.8 (±8.5) % from baseline levels. Following a s.c. injection of 0.6 mg kg -1 TAK-079, C max was 23.0 (%CV: 67) ng mL -1 with time to C max of 24 (range 7.98-96.02) hours, and plasmablasts were subsequently reduced 93.4 (±8.8) % from predose levels. Serum immunoglobulin (Ig)M, IgA and IgG levels were reduced by 15-60% and had not returned to baseline levels within 78 days after administration at ≥0.3 mg kg -1 s.c. Reductions in NK cells at 0.6 mg kg -1 s.c. were approximately 2-3 times more durable than at 0.06 mg kg -1 i.v. CONCLUSIONS TAK-079 was well tolerated and s.c. administration elicited more durable reductions in plasmablasts and NK cells. This plasmacytolytic profile could be useful for treating disorders caused by plasma or NK cells, malignant counterparts, and/or pathogenic antibodies.",2020,"Serum IgM, IgA and IgG levels were reduced by 15% to 60% and had not returned to baseline levels within 78 days after administration at ≥0.3 mg kg -1 s.c.","['Healthy Subjects', 'healthy subjects (n=74']","['placebo', 'TAK-079', 'single intravenous (i.v.) infusion or subcutaneous (s.c']","['CD38-expressing cells; clinical symptoms included mild pyrexia, headache, and postural hypotension', 'Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of the Anti-CD38 Cytolytic Antibody TAK-079', 'durable reductions in plasmablasts and NK cells', 'Serum IgM, IgA and IgG levels', 'tolerated', 'transient cytokine level', 'Reductions in NK cells']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C1522438', 'cui_str': 'SC use'}]","[{'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0239574', 'cui_str': 'Low grade fever'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0020651', 'cui_str': 'Hypotension, Postural'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0229657', 'cui_str': 'Plasmablast (cell)'}, {'cui': 'C0022688', 'cui_str': 'NK Cells'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0020861', 'cui_str': 'IgM'}, {'cui': 'C0020835', 'cui_str': 'Immunoglobulin A'}, {'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205374', 'cui_str': 'Transitory (qualifier value)'}, {'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}]",,0.468853,"Serum IgM, IgA and IgG levels were reduced by 15% to 60% and had not returned to baseline levels within 78 days after administration at ≥0.3 mg kg -1 s.c.","[{'ForeName': 'Eric R', 'Initials': 'ER', 'LastName': 'Fedyk', 'Affiliation': 'Takeda Pharmaceuticals International, Deerfield, IL, USA.'}, {'ForeName': 'Lin', 'Initials': 'L', 'LastName': 'Zhao', 'Affiliation': 'Takeda Pharmaceuticals International, Deerfield, IL, USA.'}, {'ForeName': 'Annelize', 'Initials': 'A', 'LastName': 'Koch', 'Affiliation': 'Parexel, Harrow, UK.'}, {'ForeName': 'Glennda', 'Initials': 'G', 'LastName': 'Smithson', 'Affiliation': 'Takeda Pharmaceuticals International, Deerfield, IL, USA.'}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Estevam', 'Affiliation': 'Takeda Oncology, Cambridge, MA, USA.'}, {'ForeName': 'Grace', 'Initials': 'G', 'LastName': 'Chen', 'Affiliation': 'Takeda Pharmaceuticals International, Deerfield, IL, USA.'}, {'ForeName': 'Gezim', 'Initials': 'G', 'LastName': 'Lahu', 'Affiliation': 'Takeda Pharmaceuticals International AG, Zurich, Switzerland.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Roepcke', 'Affiliation': 'Takeda Pharmaceuticals International AG, Zurich, Switzerland.'}, {'ForeName': 'Jianchang', 'Initials': 'J', 'LastName': 'Lin', 'Affiliation': 'Takeda Oncology, Cambridge, MA, USA.'}, {'ForeName': 'Lachy', 'Initials': 'L', 'LastName': 'Mclean', 'Affiliation': 'Takeda California, San Diego, CA, USA.'}]",British journal of clinical pharmacology,['10.1111/bcp.14241'] 3078,30968542,Role of the extent of prophylactic regional lymph node radiotherapy on survival in high-risk neuroblastoma: A report from the COG A3973 study.,"PURPOSE Neuroblastoma is the most common extracranial solid pediatric malignancy, with poor outcomes in high-risk disease. Standard treatment approaches employ an increasing array of aggressive multimodal therapies, of which local control with surgery and radiotherapy remains a backbone; however, the benefit of broad regional nodal irradiation remains controversial. We analyzed centrally reviewed radiation therapy data from patients enrolled on COG A3973 to evaluate the impact of primary site irradiation and the extent of regional nodal coverage stratified by extent of surgical resection. METHODS Three hundred thirty high-risk neuroblastoma patients with centrally reviewed radiotherapy plans were analyzed. Outcome was evaluated by the extent of nodal irradiation. For the 171 patients who also underwent surgery (centrally reviewed), outcome was likewise analyzed according to the extent of resection. Overall survival (OS), event-free survival (EFS), and cumulative incidence of local progression (CILP) were examined by Kaplan-Meier, log-rank test (EFS, OS), and Grey test (CILP). RESULTS The five-year CILP, EFS, and OS for all 330 patients receiving radiotherapy on A3973 were 8.5% ± 1.5%, 47.2% ± 3.0%, and 59.7% ± 3.0%, respectively. There were no significant differences in outcomes based on the extent of lymph node irradiation regardless of the degree of surgical resection (< 90% or ≥90%). CONCLUSION Although local control remains a significant component of treatment of high-risk neuroblastoma, our results suggest there is no benefit of extensive lymph node irradiation, irrespective of the extent of surgical resection preceding stem cell transplant.",2019,"There were no significant differences in outcomes based on the extent of lymph node irradiation regardless of the degree of surgical resection (< 90% or ≥90%). ","['patients enrolled on COG A3973', '171 patients who also underwent surgery (centrally reviewed', '330 patients receiving', 'Three hundred thirty high-risk neuroblastoma patients with centrally reviewed radiotherapy plans were analyzed', 'high-risk neuroblastoma']","['radiotherapy', 'prophylactic regional lymph node radiotherapy']","['degree of surgical resection', 'survival', 'Kaplan-Meier, log-rank test (EFS, OS), and Grey test (CILP', 'Overall survival (OS), event-free survival (EFS), and cumulative incidence of local progression (CILP']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0282443', 'cui_str': 'Review'}, {'cui': 'C4517719', 'cui_str': '330 (qualifier value)'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0027819', 'cui_str': 'Neuroblastoma'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C1301732', 'cui_str': 'Planned'}]","[{'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0445202', 'cui_str': 'Prophylactic (qualifier value)'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0024204', 'cui_str': 'Lymphatic gland'}]","[{'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0699794', 'cui_str': 'Rank (attribute)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}]",330.0,0.0561755,"There were no significant differences in outcomes based on the extent of lymph node irradiation regardless of the degree of surgical resection (< 90% or ≥90%). ","[{'ForeName': 'Steve E', 'Initials': 'SE', 'LastName': 'Braunstein', 'Affiliation': 'Department of Radiation Oncology, University of California, San Francisco, California.'}, {'ForeName': 'Wendy B', 'Initials': 'WB', 'LastName': 'London', 'Affiliation': ""Department of Pediatric Oncology/Hematology, Biostatistics Division, Dana-Farber Cancer Institute, Boston Children's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Susan G', 'Initials': 'SG', 'LastName': 'Kreissman', 'Affiliation': 'Department of Pediatrics, Duke University School of Medicine, Durham, North Carolina.'}, {'ForeName': 'Judith G', 'Initials': 'JG', 'LastName': 'Villablanca', 'Affiliation': 'Department of Pediatrics, Keck School of Medicine, University of Southern California, Los Angeles, California.'}, {'ForeName': 'Andrew M', 'Initials': 'AM', 'LastName': 'Davidoff', 'Affiliation': ""Department of Surgery, Pediatrics Division, St. Jude's Children's Research Hospital, Memphis, Tennessee.""}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'DeSantes', 'Affiliation': 'Department of Pediatrics, University of Wisconsin, School of Medicine and Public Health, Madison, Wisconsin.'}, {'ForeName': 'Robert P', 'Initials': 'RP', 'LastName': 'Castleberry', 'Affiliation': 'Department of Pediatrics, University of Alabama Medical Center, Tuscaloosa, Alabama.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Murray', 'Affiliation': 'Department of Pediatrics, University of Louisville, Louisville, Kentucky.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Diller', 'Affiliation': ""Department of Pediatric Oncology/Hematology, Dana-Farber Cancer Institute, Boston Children's Hospital, Boston, Massachusetts.""}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Matthay', 'Affiliation': 'Department of Pediatric Hematology-Oncology, University of California, San Francisco, California.'}, {'ForeName': 'Susan L', 'Initials': 'SL', 'LastName': 'Cohn', 'Affiliation': 'Department of Pediatrics, Section of Hematology/Oncology, University of Chicago, Chicago, Illinois.'}, {'ForeName': 'Barry', 'Initials': 'B', 'LastName': 'Shulkin', 'Affiliation': ""Department of Diagnostic Imaging, Pediatrics Division, St. Jude's Children's Research Hospital, Memphis, Tennessee.""}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'von Allmen', 'Affiliation': ""Department of Pediatric Surgery, Cincinnati Children's Hospital, Cincinnati, Ohio.""}, {'ForeName': 'Marguerite T', 'Initials': 'MT', 'LastName': 'Parisi', 'Affiliation': ""Department of Radiology, University of Washington, Seattle Children's Hospital, Seattle, Washington.""}, {'ForeName': 'Collin', 'Initials': 'C', 'LastName': 'Van Ryn', 'Affiliation': 'Department of Biostatistics, University of Florida, Gainesville, Florida.'}, {'ForeName': 'Julie R', 'Initials': 'JR', 'LastName': 'Park', 'Affiliation': 'Department of Pediatrics, University of Wisconsin, School of Medicine and Public Health, Madison, Wisconsin.'}, {'ForeName': 'Michael P', 'Initials': 'MP', 'LastName': 'La Quaglia', 'Affiliation': 'Department of Pediatric Surgery, Memorial Sloan Kettering Cancer Center, New York, New York.'}, {'ForeName': 'Daphne A', 'Initials': 'DA', 'LastName': 'Haas-Kogan', 'Affiliation': ""Department of Radiation Oncology, Dana-Farber Cancer Institute, Brigham and Women's Hospital, Boston, Massachusetts.""}]",Pediatric blood & cancer,['10.1002/pbc.27736'] 3079,31813359,Effect of Additional Rehabilitation After Botulinum Toxin-A on Upper Limb Activity in Chronic Stroke: The InTENSE Trial.,"Background and Purpose- The aim of this trial was to determine the effect of additional upper limb rehabilitation following botulinum toxin-A for upper limb activity in chronic stroke. Methods- We conducted a multicenter phase III randomized trial with concealed allocation, blinded measurement, and intention-to-treat analysis. One hundred forty stroke survivors who were scheduled to receive botulinum toxin-A in any muscle(s) that cross the wrist because of moderate to severe spasticity after a stroke >3 months ago, who had completed formal rehabilitation and had no significant cognitive impairment. Experimental group received botulinum toxin-A plus evidence-based movement training while the control group received botulinum toxin-A plus a handout of exercises. Primary outcomes were goal attainment (Goal Attainment Scaling) and upper limb activity (Box and Block Test) at 3 months (end of intervention). Secondary outcomes were spasticity, range of motion, strength, pain, burden of care, and health-related quality of life. Results- In terms of goal attainment, the experimental group scored the same (mean difference, 2 T-score [95% CI, -2 to 7]) as the control group on the Goal Attainment Scale. In terms of upper limb activity, by 3 months the experimental group moved blocks at the same speed (mean difference, 0.00 blocks/s [95% CI, -0.02 to 0.01]) as the control group on the Box and Block Test. There were no differences between groups on any secondary outcome except strength, in favor of the experimental group (mean difference, 1.4 kg [95% CI, 0.2-2.7]). Conclusions- Findings suggest that additional intensive upper limb rehabilitation following botulinum toxin-A in chronic stroke survivors with a disabled upper limb is not effective. Registration- URL: https://www.clinicaltrials.gov. Unique identifier: ACTRN12615000616572.",2020,Primary outcomes were goal attainment (Goal Attainment Scaling) and upper limb activity (Box and Block Test) at 3 months (end of intervention).,"['One hundred forty stroke survivors who were scheduled to receive botulinum toxin-A in any muscle(s) that cross the wrist because of moderate to severe spasticity after a stroke >3 months ago, who had completed formal rehabilitation and had no significant cognitive impairment', 'Chronic Stroke', 'chronic stroke', 'chronic stroke survivors']","['botulinum toxin-A plus evidence-based movement training while the control group received botulinum toxin-A plus a handout of exercises', 'Additional Rehabilitation', 'Botulinum Toxin-A', ' and Purpose', 'botulinum toxin-A', 'Methods']","['upper limb activity', 'Goal Attainment Scale', 'goal attainment (Goal Attainment Scaling) and upper limb activity (Box and Block Test', 'spasticity, range of motion, strength, pain, burden of care, and health-related quality of life']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0006055', 'cui_str': 'Botulin'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0205203', 'cui_str': 'Crossed (qualifier value)'}, {'cui': 'C0043262', 'cui_str': 'Wrist'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0026838', 'cui_str': 'Muscle Spasticity'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C0750502', 'cui_str': 'Significant'}, {'cui': 'C0338656', 'cui_str': 'Cognitive Dysfunction'}, {'cui': 'C3536593', 'cui_str': 'Chronic stroke'}]","[{'cui': 'C0006055', 'cui_str': 'Botulin'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1306847', 'cui_str': 'Rehabilitation - specialty'}, {'cui': 'C1285529', 'cui_str': 'Purpose (attribute)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}]","[{'cui': 'C0579116', 'cui_str': 'Upper limb activities (regime/therapy)'}, {'cui': 'C0018017', 'cui_str': 'Goals'}, {'cui': 'C0222045'}, {'cui': 'C1638312', 'cui_str': 'Boxes'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0026838', 'cui_str': 'Muscle Spasticity'}, {'cui': 'C0080078', 'cui_str': 'Range of Motion'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}]",,0.163523,Primary outcomes were goal attainment (Goal Attainment Scaling) and upper limb activity (Box and Block Test) at 3 months (end of intervention).,"[{'ForeName': 'Natasha A', 'Initials': 'NA', 'LastName': 'Lannin', 'Affiliation': 'From the Department of Neurosciences, Central Clinical School (N.A.L.), Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Ada', 'Affiliation': 'Faculty of Health Sciences (Physiotherapy) (L.A.), The University of Sydney, New South Wales, Australia.'}, {'ForeName': 'Coralie', 'Initials': 'C', 'LastName': 'English', 'Affiliation': 'School of Health Sciences and Priority Research Centre for Stroke and Brain Injury, University of Newcastle, New South Wales, Australia (C.E.).'}, {'ForeName': 'Julie', 'Initials': 'J', 'LastName': 'Ratcliffe', 'Affiliation': 'College of Nursing and Health Sciences (J.R.), Flinders University, Adelaide, South Australia, Australia.'}, {'ForeName': 'Steven G', 'Initials': 'SG', 'LastName': 'Faux', 'Affiliation': ""Sacred Heart Rehabilitation Unit, St Vincent's Hospital, Sydney, New South Wales, Australia (S.G.F.).""}, {'ForeName': 'Mithu', 'Initials': 'M', 'LastName': 'Palit', 'Affiliation': 'Alfred Health, Melbourne, Victoria, Australia (N.A.L., M.P.).'}, {'ForeName': 'Senen', 'Initials': 'S', 'LastName': 'Gonzalez', 'Affiliation': 'Austin Health, Melbourne, Victoria, Australia (S.G.).'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Olver', 'Affiliation': 'Epworth Monash Rehabilitation Medicine Research Unit (J.O.), Monash University, Melbourne, Victoria, Australia.'}, {'ForeName': 'Ian', 'Initials': 'I', 'LastName': 'Cameron', 'Affiliation': 'John Walsh Centre for Rehabilitation Research (I.C.), The University of Sydney, New South Wales, Australia.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Crotty', 'Affiliation': 'Rehabilitation and Aged Care, College of Medicine and Public Health (M.C.), Flinders University, Adelaide, South Australia, Australia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Stroke,['10.1161/STROKEAHA.119.027602'] 3080,32074624,Cognitive Remediation Therapy Does Not Enhance Treatment Effect in Obsessive-Compulsive Disorder and Anorexia Nervosa: A Randomized Controlled Trial.,"BACKGROUND Guideline-recommended therapies are moderately successful in the treatment of obsessive-compulsive disorder (OCD) and anorexia nervosa (AN), leaving room for improvement. Cognitive inflexibility, a common trait in both disorders, is likely to prevent patients from engaging in treatment and from fully benefiting from existing therapies. Cognitive remediation therapy (CRT) is a practical augmentation intervention aimed at ameliorating this impairing cognitive style prior to disorder-specific therapy. OBJECTIVE To compare the effectiveness of CRT and a control treatment that was not aimed at enhancing flexibility, named specialized attention therapy (SAT), as add-ons to treatment as usual (TAU). METHODS In a randomized controlled multicenter clinical trial, 71 adult patients with OCD and 61 with AN were randomized to ten twice-weekly sessions with either CRT or SAT, followed by TAU. Patients were evaluated at baseline, post-CRT/SAT, and after 6 and 12 months, with outcomes being quantified using the Yale-Brown Obsessive Compulsive Scale for OCD and the Eating Disorder Examination Questionnaire for AN. RESULTS Across study groups, most importantly CRT+TAU was not superior to control treatment (SAT)+TAU in reducing OCD and AN pathology. Contrary to expectations, SAT+TAU may have been more effective than CRT+TAU in patients being treated for OCD. CONCLUSIONS CRT did not enhance the effect of TAU for OCD and AN more than SAT. Unexpectedly, SAT, the control condition, may have had an augmentation effect on TAU in OCD patients. Although this latter finding may have been due to chance, the effect of SAT delivered as a pretreatment add-on intervention for adults with OCD and AN merits future efforts at replication.",2020,"To compare the effectiveness of CRT and a control treatment that was not aimed at enhancing flexibility, named specialized attention therapy (SAT), as add-ons to treatment as usual (TAU). ","['Obsessive-Compulsive Disorder and Anorexia Nervosa', 'adults with OCD', 'patients being treated for OCD', '71 adult patients with OCD and 61 with AN']","['Cognitive remediation therapy (CRT', 'Cognitive Remediation Therapy', 'CRT or SAT, followed by TAU', 'CRT']",['Yale-Brown Obsessive Compulsive Scale for OCD and the Eating Disorder Examination Questionnaire'],"[{'cui': 'C0028768', 'cui_str': 'Anankastic Personality'}, {'cui': 'C0003125', 'cui_str': 'Anorexia Nervosas'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332154', 'cui_str': 'Received therapy or drug for (contextual qualifier) (qualifier value)'}]","[{'cui': 'C4277695', 'cui_str': 'Cognitive Remediation'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2584297', 'cui_str': 'Seated Position'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C1720655', 'cui_str': 'Tau'}]","[{'cui': 'C0678579', 'cui_str': 'Brown'}, {'cui': 'C0222045'}, {'cui': 'C2960501', 'cui_str': 'Eating disorder examination questionnaire (assessment scale)'}]",71.0,0.119911,"To compare the effectiveness of CRT and a control treatment that was not aimed at enhancing flexibility, named specialized attention therapy (SAT), as add-ons to treatment as usual (TAU). ","[{'ForeName': 'Boris', 'Initials': 'B', 'LastName': 'van Passel', 'Affiliation': 'Overwaal Center for Anxiety Disorders, OCD, and PTSD, Pro Persona Institute for Integrated Mental Health Care, Nijmegen, The Netherlands, b.van.passel@propersona.nl.'}, {'ForeName': 'Unna N', 'Initials': 'UN', 'LastName': 'Danner', 'Affiliation': 'Altrecht Eating Disorders Rintveld, Zeist, The Netherlands.'}, {'ForeName': 'Alexandra E', 'Initials': 'AE', 'LastName': 'Dingemans', 'Affiliation': 'Rivierduinen Eating Disorders Ursula, Leiden, The Netherlands.'}, {'ForeName': 'Emmeke', 'Initials': 'E', 'LastName': 'Aarts', 'Affiliation': 'Department of Methodology and Statistics, Utrecht University, Utrecht, The Netherlands.'}, {'ForeName': 'Lot C', 'Initials': 'LC', 'LastName': 'Sternheim', 'Affiliation': 'Altrecht Eating Disorders Rintveld, Zeist, The Netherlands.'}, {'ForeName': 'Eni S', 'Initials': 'ES', 'LastName': 'Becker', 'Affiliation': 'Behavioral Science Institute, Radboud University, Nijmegen, The Netherlands.'}, {'ForeName': 'Annemarie A', 'Initials': 'AA', 'LastName': 'van Elburg', 'Affiliation': 'Altrecht Eating Disorders Rintveld, Zeist, The Netherlands.'}, {'ForeName': 'Eric F', 'Initials': 'EF', 'LastName': 'van Furth', 'Affiliation': 'Rivierduinen Eating Disorders Ursula, Leiden, The Netherlands.'}, {'ForeName': 'Gert-Jan', 'Initials': 'GJ', 'LastName': 'Hendriks', 'Affiliation': 'Overwaal Center for Anxiety Disorders, OCD, and PTSD, Pro Persona Institute for Integrated Mental Health Care, Nijmegen, The Netherlands.'}, {'ForeName': 'Daniëlle C', 'Initials': 'DC', 'LastName': 'Cath', 'Affiliation': 'Department of Clinical Psychology, Utrecht University, Utrecht, The Netherlands.'}]",Psychotherapy and psychosomatics,['10.1159/000505733'] 3081,31376167,Professional tooth cleaning prior to non-surgical periodontal therapy: A randomized clinical trial.,"BACKGROUND This study was aimed to investigate if professional oral prophylaxis before scaling and root planing (SRP) has an effect on the outcome of non-surgical periodontal treatment in patients with chronic periodontitis. METHODS Fifty-two individuals with chronic periodontitis receiving non-surgical periodontal therapy by SRP with (test) and without (control) two appointments of professional tooth cleaning but with motivation and instruction were monitored for clinical variables, four selected microorganisms and two biomarkers at baseline, before SRP as well as 3 and 6 months after SRP. Statistical analysis included non-parametric tests for intra- and intergroup comparisons. RESULTS Probing depth (PD), attachment level, bleeding on probing (BOP), and interproximal plaque index (API) were significantly improved in both groups 3 and 6 months after SRP. PD, BOP, API, and the number of sites with PD ≥5 mm were significantly lower in the test group than in the control group at the appointment immediately before SRP. Tannerella forsythia was significantly reduced in both groups at 3 and 6 months, Porphyromonas gingivalis only in the test group. Interleukin-1β was significantly reduced in the control group 3 and 6 months after SRP, matrix metalloproteinase-8 level decreased in the test group 3 months after SRP. There was no significant difference of any clinical and non-clinical variable between both groups at 3 and 6 months after SRP. CONCLUSIONS Professional tooth cleaning before the SRP does not improve the clinical results of the SRP. It has no obvious long-lasting effects on major periodontopathogens in the subgingival biofilm as well as on biomarkers in the gingival crevicular fluid after SRP.",2020,"There was no significant difference of any clinical and non-clinical variable between both groups at three and six months after SRP. ","['patients with chronic periodontitis', 'Fifty-two individuals with chronic periodontitis receiving nonsurgical periodontal therapy by SRP with (test) and without (control) two appointments of professional tooth cleaning but with motivation and instruction']",['root planing (SRP'],"['IL-1β', 'MMP-8 level', 'PD, BOP, API and the number of sites with PD', 'PD, AL, BOP and interproximal plaque index (API', 'T. forsythia']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0266929', 'cui_str': 'Adult Periodontitis'}, {'cui': 'C4319570', 'cui_str': 'Fifty-two'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0003629', 'cui_str': 'Appointments'}, {'cui': 'C0040426', 'cui_str': 'Tooth'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0039401', 'cui_str': 'Teaching'}]","[{'cui': 'C0085287', 'cui_str': 'Root Planings'}]","[{'cui': 'C0623362', 'cui_str': 'MMPs'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0390024', 'cui_str': 'API0134'}, {'cui': 'C0445108', 'cui_str': 'Number of sites (qualifier value)'}, {'cui': 'C0332461', 'cui_str': 'Plaque (morphologic abnormality)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C1018538', 'cui_str': 'Goldenbells'}]",52.0,0.050013,"There was no significant difference of any clinical and non-clinical variable between both groups at three and six months after SRP. ","[{'ForeName': 'Holger F R', 'Initials': 'HFR', 'LastName': 'Jentsch', 'Affiliation': 'Center for Periodontology, Department of Cariology, Endodontology and Periodontology, University Hospital of Leipzig, Leipzig, Germany.'}, {'ForeName': 'Thea', 'Initials': 'T', 'LastName': 'Heusinger', 'Affiliation': 'Private Dental Practice, Drei Gleichen, Germany.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Weickert', 'Affiliation': 'Private Dental Practice, Drei Gleichen, Germany.'}, {'ForeName': 'Sigrun', 'Initials': 'S', 'LastName': 'Eick', 'Affiliation': 'Department of Periodontology, School of Dental Medicine, University of Bern, Bern, Switzerland.'}]",Journal of periodontology,['10.1002/JPER.19-0023'] 3082,31373942,A Knowledge Translation Intervention Designed and Implemented by a Knowledge Broker Improved Documented Use of Gait Speed: A Mixed-Methods Study.,"BACKGROUND AND PURPOSE Although outcome measures are a valuable part of physical therapy practice, there is a gap in routine outcome measurement use by physical therapists (PTs). Knowledge brokers (KBs) are individuals who can collaborate with PTs to facilitate outcome measure use. The purpose of this study was to determine whether an intervention tailored by an external KB, cocreated with the PTs and supported by the supervisor, would increase the use of gait speed by PTs working at an inpatient subacute rehabilitation hospital. METHODS A mixed-methods study was conducted with 11 PTs. The 2-month intervention included education, documentation changes, audit and feedback, goal setting, and organizational support. Use of the 4-meter walk test was measured through chart audits and was self-assessed with the Goal Attainment Scale. Proportions were calculated to determine the number of times gait speed was documented by the PTs both at initial examination (IE) and at discharge. A repeated-measures analysis of variance was used to determine significant differences from baseline (3-month retrospective chart audit), 0 to 2, 2 to 4, 4 to 6, and 6 to 8 months. A Wilcoxon signed rank test was used to determine significant differences in self-reported use on the Goal Attainment Scale month 0 to month 2. Focus groups immediately following the intervention (month 2) and at follow-up (month 9) were used to determine barriers to measuring gait speed and perceptions of the intervention. Open coding was used to identify key themes. A comparison group of per diem PTs was trained by the supervisor between months 4 and 8, using the approach developed by the KB. The comparison group was included as their training may have influenced the experimental groups' outcome. Chart audit data for the comparison group from months 0 to 2, 2 to 4, 4 to 6, and 6 to 8 were reported descriptively. RESULTS AND DISCUSSION Documentation of the 4-meter walk test significantly improved from the 3-month retrospective chart audit at baseline (0% IE, 0% discharge) to months 0 to 2 at IE (mean = 71%, SD = 31 %, F = 9.30, P < .001) and discharge (mean = 66%, SD = 30%, F = 14.16, P < .001) and remained significantly higher at months 6 to 8 follow-up for IE (mean= 63%, SD 21%) and discharge (mean=59%, SD 32%). Eleven PTs participated in the focus group at month 2 and reported that the knowledge translation strategies including documentation changes, environmental cues, and social support helped facilitate their behavior change. Lack of space and the patient's activity limitations were barriers. The PTs significantly improved self-reported use of gait speed using the Goal Attainment Scale from month 0 to month 2 at IE: -2 to 0 (0% use to 50%) (Z = -2.842, P = .004) and discharge: -2 to 1 (0% use to 75%) (Z = -2.448, P = .014). The comparison group increased documented use of gait speed from 0% to 25% at IE and 47% at discharge between months 6 and 8. CONCLUSION The KB, with supervisor support, successfully collaborated with the PTs to tailor an intervention to address local barriers to consistently use the 4-meter walk test. The PTs significantly improved the documented use of gait speed following the intervention. The PTs reported that the intervention facilitated outcome measure use although barriers to using gait speed remained.",2020,"The PTs significantly improved self-reported use of gait speed using the Goal Attainment Scale from month 0 to month 2 at IE: -2 to 0 (0% use to 50%) (Z = -2.842, P = .004) and discharge: -2 to 1 (0% use to 75%) (Z = -2.448, P = .014).",['A mixed-methods study was conducted with 11 PTs'],[],"['gait speed', 'Gait Speed', 'number of times gait speed', 'discharge', 'education, documentation changes, audit and feedback, goal setting, and organizational support', 'gait speed using the Goal Attainment Scale']","[{'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}]",[],"[{'cui': 'C2009910', 'cui_str': 'Gait Speed'}, {'cui': 'C0449809', 'cui_str': 'Number of times (qualifier value)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0920316', 'cui_str': 'Documentation'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}, {'cui': 'C0150598', 'cui_str': 'Goal setting (qualifier value)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0018017', 'cui_str': 'Goals'}, {'cui': 'C0222045'}]",,0.0274026,"The PTs significantly improved self-reported use of gait speed using the Goal Attainment Scale from month 0 to month 2 at IE: -2 to 0 (0% use to 50%) (Z = -2.842, P = .004) and discharge: -2 to 1 (0% use to 75%) (Z = -2.448, P = .014).","[{'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Romney', 'Affiliation': 'Department of Physical Therapy and Human Movement Science, College of Health Professions, Sacred Heart University, Fairfield, Connecticut.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Salbach', 'Affiliation': 'Department of Physical Therapy, School of Graduate Studies, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': 'James Scott', 'Initials': 'JS', 'LastName': 'Parrott', 'Affiliation': 'Department of Interdisciplinary Studies, School of Health Professions, Rutgers, The State University of New Jersey, Newark, NJ.'}, {'ForeName': 'Judith E', 'Initials': 'JE', 'LastName': 'Deutsch', 'Affiliation': 'Department of Rehabilitation and Movement Sciences, School of Health Professions, Rutgers, The State University of New Jersey, Newark, NJ.'}]",Journal of geriatric physical therapy (2001),['10.1519/JPT.0000000000000239'] 3083,31371154,Haemostasis in oral surgical procedures involving patients with a ventricular assist device.,"The purpose of this study was to determine whether tooth extraction for patients with ventricular assist devices (VADs) could be performed without interruption of anticoagulant and/or antiplatelet therapy and whether treatment with von Willebrand factor concentrates and desmopressin is required. The study consisted of three groups of patients undergoing oral surgery. The two experimental groups comprised patients with VADs, while the third group included cardiovascular patients without VADs who served as controls. All patients were treated intraoperatively with topical haemostatic agents (oxidized cellulose or collagen). The first group was additionally treated with fibrin glue. All 75 oral surgical procedures were performed under local anaesthesia without sedation. Three of 40 patients in the experimental groups and two of 20 patients in the control group suffered a haemorrhage, with no significant difference in the incidence of haemorrhage between the groups. The findings suggest that dental extraction can be performed without modification of oral anticoagulation or antiplatelet treatments, providing that INR is less than 3.5 on the day of the operation. It can further be hypothesized that an acquired coagulopathy in VAD patients does not influence the bleeding risk in dental extractions, and so the administration of desmopressin and/or von Willebrand factor concentrates is not required.",2019,"Three of 40 patients in the experimental groups and two of 20 patients in the control group suffered a haemorrhage, with no significant difference in the incidence of haemorrhage between the groups.","['patients with VADs, while the third group included cardiovascular patients without VADs who served as controls', 'patients undergoing oral surgery', 'patients with ventricular assist devices (VADs', 'patients with a ventricular assist device']","['local anaesthesia without sedation', 'topical haemostatic agents (oxidized cellulose or collagen', 'fibrin glue']","['incidence of haemorrhage', 'haemorrhage']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0038908', 'cui_str': 'Surgery, Maxillofacial'}, {'cui': 'C0085842', 'cui_str': 'Artificial Ventricle'}]","[{'cui': 'C0002921', 'cui_str': 'Local anesthesia (procedure)'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0019120', 'cui_str': 'Hemostatics'}, {'cui': 'C0007649', 'cui_str': 'Absorbable Cellulose'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0016004', 'cui_str': 'Fibrin Glue'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C1869041', 'cui_str': 'Haemorrhages (SMQ)'}]",,0.0222906,"Three of 40 patients in the experimental groups and two of 20 patients in the control group suffered a haemorrhage, with no significant difference in the incidence of haemorrhage between the groups.","[{'ForeName': 'N A', 'Initials': 'NA', 'LastName': 'Hamzah', 'Affiliation': 'Department of Oral, Maxillofacial and Facial Plastic Surgery, University Hospital Leipzig, Leipzig, Germany. Electronic address: hamzah@medizin.uni-leipzig.de.'}, {'ForeName': 'H L', 'Initials': 'HL', 'LastName': 'Graf', 'Affiliation': 'Department of Oral, Maxillofacial and Facial Plastic Surgery, University Hospital Leipzig, Leipzig, Germany.'}, {'ForeName': 'Milena R', 'Initials': 'MR', 'LastName': 'Kaluđerović', 'Affiliation': 'Department of Oral, Maxillofacial and Facial Plastic Surgery, University Hospital Leipzig, Leipzig, Germany; Practice for Maxillofacial Surgery, Lepsiusstraße 2, 06618 Naumburg, Germany.'}, {'ForeName': 'A L', 'Initials': 'AL', 'LastName': 'Meyer', 'Affiliation': 'University Department for Cardiac Surgery, Leipzig Heart Centre, Leipzig, Germany.'}, {'ForeName': 'M T', 'Initials': 'MT', 'LastName': 'Dieterlen', 'Affiliation': 'University Department for Cardiac Surgery, Leipzig Heart Centre, Leipzig, Germany.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Hemprich', 'Affiliation': 'Department of Oral, Maxillofacial and Facial Plastic Surgery, University Hospital Leipzig, Leipzig, Germany.'}]",International journal of oral and maxillofacial surgery,['10.1016/j.ijom.2019.07.009'] 3084,32073330,Does adolescent self-reported TMD pain persist into early adulthood? A longitudinal study.,"Objective: To follow up 2209 individuals in a longitudinal study and assess self-reported TMD pain, painful and non-painful comorbid conditions, and pain-related disability. Material and methods: During 2012-2014, questionnaires were sent to 2209 eligible individuals who had been screened for TMD pain each year during 2000-2003. The two screening questions were (1) Do you have pain in the temple, face, jaw joint, or jaws once a week or more often? and (2) Do you have pain when you open your mouth wide or chew once a week or more often? If the patient answered 'yes' to one or both of the questions, TMD pain was recorded. Non-respondents received reminders; telephone interviews were offered a randomised group. The questionnaire queried TMD pain, and painful and non-painful comorbid conditions. Results: The overall response rate was 36.5%. Individuals were placed into one of four pain groups defined by their pain experience at baseline and at the follow-up: no TMD pain (69.0%), new TMD pain (13.0%), previous TMD pain (9.9%), and persistent TMD pain (8.1%). Based on the self-report surveys, significantly more responders with TMD pain at follow-up had had pain as adolescents than not. Of adolescents with TMD pain, 45.1% had pain at follow-up as young adults, while 15.8% had pain at follow-up without a previous history of TMD pain. Individuals with persistent TMD pain had high frequencies of comorbid pains ( p  < .001), 45.2% reported moderate-severe depression scores ( p  < .001), and 13.0% had moderate pain-related disability (GCPS). Conclusions: Based on self-report surveys, TMD pain in adolescence appears to triple the risk of TMD pain in young adulthood, and persistent pain increased comorbid pain and psychosocial distress.",2020,"Individuals with persistent TMD pain had high frequencies of comorbid pains ( p  < .001), 45.2% reported moderate-severe depression scores ( p  < .001), and 13.0% had moderate pain-related disability (GCPS).","['2209 individuals in a longitudinal study and assess self-reported TMD pain, painful and non-painful comorbid conditions, and pain-related disability', 'During 2012-2014, questionnaires were sent to 2209 eligible individuals who had been screened for TMD pain each year during 2000-2003']",[],"['previous TMD pain', 'new TMD pain', 'comorbid pains', 'moderate-severe depression scores', 'TMD pain', 'moderate pain-related disability (GCPS', 'overall response rate', 'pain', 'questionnaire queried TMD pain, and painful and non-painful comorbid conditions', 'persistent TMD pain']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0023981', 'cui_str': 'Longitudinal Studies'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C1275743', 'cui_str': 'Comorbid conditions'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0470277', 'cui_str': '2000'}]",[],"[{'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0588008', 'cui_str': 'Severe depression (disorder)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0278139', 'cui_str': 'Moderate pain (finding)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C3543841', 'cui_str': 'Query'}, {'cui': 'C1275743', 'cui_str': 'Comorbid conditions'}]",2209.0,0.0412799,"Individuals with persistent TMD pain had high frequencies of comorbid pains ( p  < .001), 45.2% reported moderate-severe depression scores ( p  < .001), and 13.0% had moderate pain-related disability (GCPS).","[{'ForeName': 'Ing-Marie', 'Initials': 'IM', 'LastName': 'Nilsson', 'Affiliation': 'Center for Oral Rehabilitation, FTV Östergötland, Norrköping, Sweden.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'List', 'Affiliation': 'Orofacial Pain and Jaw Function, Malmö University, Malmö, Sweden.'}]",Acta odontologica Scandinavica,['10.1080/00016357.2020.1730000'] 3085,32075590,Pain reduction by inducing sensory-motor adaptation in Complex Regional Pain Syndrome (CRPS PRISMA): protocol for a double-blind randomized controlled trial.,"BACKGROUND Complex Regional Pain Syndrome (CRPS) presents as chronic, continuous pain and sensory, autonomic, and motor abnormalities affecting one or more extremities. People with CRPS can also show changes in their perception of and attention to the affected body part and sensory information in the affected side of space. Prism Adaptation (PA) is a behavioural intervention targeted at reducing attention deficits in post-stroke hemispatial neglect. PA also appears to reduce pain and other CRPS symptoms; however, these therapeutic effects have been demonstrated only in small unblinded studies. This paper describes the protocol for an ongoing double-blind, randomized, sham-controlled clinical trial that will evaluate the efficacy of PA treatment for CRPS. The secondary aims of the study are to examine the relationships between neuropsychological changes (such as spatial attention, space and body representation, and motor spatial performance) and clinical manifestations of CRPS, as well as symptom improvement. METHODS Forty-two participants with upper-limb CRPS type I will undergo 2 weeks of twice-daily PA treatment or sham treatment. The primary outcome measures are current pain intensity and CRPS severity score, measured immediately before and after the treatment period. Secondary outcome measures include the results of self-report questionnaires about pain, movement, symptoms interference, and body representation; clinical assessments of sensory, motor, and autonomic functions; and computer-based psychophysical tests of neuropsychological functions. Data are collected in four research visits: 4 weeks and 1 day before treatment, and 1 day and 4 weeks after the end of treatment. Additional follow-up through postal questionnaires is conducted 3 and 6 months post-treatment. DISCUSSION It is hypothesised that participants undergoing PA treatment, compared to those receiving sham treatment, will show greater reduction in pain and CRPS severity score, and improvements on other clinical and neuropsychological measures. Also, more pronounced neuropsychological symptoms are predicted to correlate with more severe clinical CRPS symptoms. This study will provide the first randomized double-blind evaluation of the therapeutic effects of PA that could be implemented as a rehabilitation method for CRPS, and will contribute to the understanding of how neuropsychological changes in body representation and attention pertain to the manifestation and treatment of CRPS. TRIAL REGISTRATION (27/03/2017): ISRCTN46828292 (ISRCTN - ISRCTN46828292: Treatment of complex regional pain syndrome (CRPS) with sensory-motor adaptation).",2020,"It is hypothesised that participants undergoing PA treatment, compared to those receiving sham treatment, will show greater reduction in pain and CRPS severity score, and improvements on other clinical and neuropsychological measures.","['participants undergoing PA treatment', 'Forty-two participants with upper-limb CRPS type I will undergo 2 weeks of', 'complex regional pain syndrome (CRPS) with sensory-motor adaptation', 'Complex Regional Pain Syndrome (CRPS PRISMA']","['twice-daily PA treatment or sham treatment', 'PA', 'Prism Adaptation (PA']","['Pain reduction', 'current pain intensity and CRPS severity score', 'pain and CRPS severity score', 'neuropsychological changes (such as spatial attention, space and body representation, and motor spatial performance', 'severe clinical CRPS symptoms', 'results of self-report questionnaires about pain, movement, symptoms interference, and body representation; clinical assessments of sensory, motor, and autonomic functions; and computer-based psychophysical tests of neuropsychological functions']","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4319566', 'cui_str': 'Forty-two'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0441729', 'cui_str': 'Type 1 (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0458219', 'cui_str': 'CRPS (Complex Regional Pain Syndromes)'}, {'cui': 'C0445254', 'cui_str': 'Sensory (qualifier value)'}, {'cui': 'C0392673', 'cui_str': 'Adaptation, function (observable entity)'}, {'cui': 'C0138404', 'cui_str': 'prisma'}]","[{'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0032042', 'cui_str': 'Sham Treatment'}, {'cui': 'C0392673', 'cui_str': 'Adaptation, function (observable entity)'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0457451', 'cui_str': 'Severity score (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}, {'cui': 'C3489573', 'cui_str': 'Body Representation'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0026649', 'cui_str': 'Movement'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0445254', 'cui_str': 'Sensory (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0009622', 'cui_str': 'Computers'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0430872', 'cui_str': 'Psychophysical tests (procedure)'}]",42.0,0.319915,"It is hypothesised that participants undergoing PA treatment, compared to those receiving sham treatment, will show greater reduction in pain and CRPS severity score, and improvements on other clinical and neuropsychological measures.","[{'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Halicka', 'Affiliation': 'Centre for Pain Research, University of Bath, Claverton Down Road, Bath, BA2 7AY, UK. m.halicka@bath.ac.uk.'}, {'ForeName': 'Axel D', 'Initials': 'AD', 'LastName': 'Vittersø', 'Affiliation': 'Centre for Pain Research, University of Bath, Claverton Down Road, Bath, BA2 7AY, UK.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Proulx', 'Affiliation': 'Department of Psychology, University of Bath, Claverton Down Road, Bath, BA2 7AY, UK.'}, {'ForeName': 'Janet H', 'Initials': 'JH', 'LastName': 'Bultitude', 'Affiliation': 'Centre for Pain Research, University of Bath, Claverton Down Road, Bath, BA2 7AY, UK.'}]",BMC neurology,['10.1186/s12883-020-1604-z'] 3086,32077300,Development of a Wellness Committee Implementation Index for Workplace Health Promotion Programs in Small Businesses.,"PURPOSE To construct a wellness committee (WC) implementation index and determine whether this index was associated with evidence-based intervention implementation in a workplace health promotion program. DESIGN Secondary data analysis of the HealthLinks randomized controlled trial. SETTING Small businesses assigned to the HealthLinks plus WC study arm. SAMPLE Small businesses (20-200 employees, n = 23) from 6 low-wage industries in King County, Washington. MEASURES Wellness committee implementation index (0%-100%) and evidence-based intervention implementation (0%-100%). ANALYSIS We used descriptive and bivariate statistics to describe worksites' organizational characteristics. For the primary analyses, we used generalized estimating equations with robust standard errors to assess the association between WC implementation index and evidence-based intervention implementation over time. RESULTS Average WC implementation index scores were 60% at 15 months and 38% at 24 months. Evidence-based intervention scores among worksites with WCs were 27% points higher at 15 months (64% vs 37%, P < .001) and 36% points higher at 24 months (55% vs 18%, P < .001). Higher WC implementation index scores were positively associated with evidence-based intervention implementation scores over time ( P < .001). CONCLUSION Wellness committees may play an essential role in supporting evidence-based intervention implementation among small businesses. Furthermore, the degree to which these WCs are engaged and have leadership support, a set plan or goals, and multilevel participation may influence evidence-based intervention implementation and maintenance over time.",2020,"Higher WC implementation index scores were positively associated with evidence-based intervention implementation scores over time ( P < .001). ","['Small Businesses', 'Small businesses assigned to the HealthLinks plus WC study arm', 'SAMPLE\n\n\nSmall businesses (20-200 employees, n = 23) from 6 low-wage industries in King County, Washington']",[],"['Average WC implementation index scores', 'Higher WC implementation index scores']","[{'cui': 'C2936313', 'cui_str': 'Microenterprise'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0441621', 'cui_str': 'Sampling - action (qualifier value)'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0599987', 'cui_str': 'Employee (person)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0036064', 'cui_str': 'Wages'}, {'cui': 'C0021267', 'cui_str': 'Industry'}, {'cui': 'C0454792', 'cui_str': 'Offaly (geographic location)'}, {'cui': 'C0043038', 'cui_str': 'Washington'}]",[],"[{'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]",,0.0927082,"Higher WC implementation index scores were positively associated with evidence-based intervention implementation scores over time ( P < .001). ","[{'ForeName': 'Meagan C', 'Initials': 'MC', 'LastName': 'Brown', 'Affiliation': 'Department of Health Services, School of Public Health, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Jeffrey R', 'Initials': 'JR', 'LastName': 'Harris', 'Affiliation': 'Department of Health Services, School of Public Health, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Kristen', 'Initials': 'K', 'LastName': 'Hammerback', 'Affiliation': 'Department of Health Services, School of Public Health, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Marlana J', 'Initials': 'MJ', 'LastName': 'Kohn', 'Affiliation': 'Department of Health Services, School of Public Health, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Amanda T', 'Initials': 'AT', 'LastName': 'Parrish', 'Affiliation': 'Department of Health Services, School of Public Health, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Gary K', 'Initials': 'GK', 'LastName': 'Chan', 'Affiliation': 'Department of Health Services, School of Public Health, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'India J', 'Initials': 'IJ', 'LastName': 'Ornelas', 'Affiliation': 'Department of Health Services, School of Public Health, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Christian D', 'Initials': 'CD', 'LastName': 'Helfrich', 'Affiliation': 'Department of Health Services, School of Public Health, University of Washington, Seattle, WA, USA.'}, {'ForeName': 'Peggy A', 'Initials': 'PA', 'LastName': 'Hannon', 'Affiliation': 'Department of Health Services, School of Public Health, University of Washington, Seattle, WA, USA.'}]",American journal of health promotion : AJHP,['10.1177/0890117120906967'] 3087,31265147,Development of a group structured education programme to support safe exercise in people with Type 1 diabetes: the EXTOD education programme.,"AIM To develop a structured education programme for individuals with Type 1 diabetes who are engaging in regular exercise. METHOD A multidisciplinary team of experts in supporting exercise and physical activity for people with Type 1 diabetes, alongside researchers with experience of developing self-management education, developed an exercise programme using the Medical Research Council framework. The programme was informed by a review of the evidence relating to Type 1 diabetes and exercise, the behaviour change literature (including the behaviour change taxonomy), and qualitative interviews with stakeholders. The programme and supporting resources were refined using an iterative process of testing, delivery and collecting feedback from participants and the wider development team. RESULTS The outcome of the intervention development was the design of a feasible and acceptable intervention for people with Type 1 diabetes to support safe exercise. The pilot allowed refinement of the intervention prior to testing in a two-site feasibility randomized controlled trial. Key findings from the pilot informed minor restructuring of the timetable (timings and order) and adaptation of supporting educational materials (participant handbook and teaching materials). CONCLUSION The 'EXercise in people with Type One Diabetes' (EXTOD) education programme has been developed using robust methodology for the generation of educational interventions. It now needs testing in a randomized controlled trial.",2020,"The programme and supporting resources were refined using an iterative process of testing, delivery and collecting feedback from participants and the wider development team. ","['individuals with Type 1 diabetes who are engaging in regular exercise', ""people with Type One Diabetes' (EXTOD) education programme"", 'people with Type 1 diabetes']","['structured education programme', 'education programme to support safe exercise']",[],"[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married (finding)'}, {'cui': 'C0582191', 'cui_str': 'Regular exercise (observable entity)'}, {'cui': 'C0729314', 'cui_str': 'Education provision (procedure)'}]","[{'cui': 'C0729314', 'cui_str': 'Education provision (procedure)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]",[],,0.0758452,"The programme and supporting resources were refined using an iterative process of testing, delivery and collecting feedback from participants and the wider development team. ","[{'ForeName': 'P', 'Initials': 'P', 'LastName': 'Narendran', 'Affiliation': 'Department of Diabetes, University Hospitals Birmingham NHS Foundation Trust, Birmingham.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Greenfield', 'Affiliation': 'Institute of Applied Health Research, University of Birmingham, Birmingham.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Troughton', 'Affiliation': 'Leicester Diabetes Centre, University Hospitals Leicester, Leicester.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Doherty', 'Affiliation': 'Department of Psychological Medicine, York Teaching Hospitals NHS Foundation Trust, York.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Quann', 'Affiliation': 'Leicester Clinical Trials Unit, College of Life Sciences, University of Leicester, Leicester.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Thompson', 'Affiliation': 'Department of Diabetes, Taunton and Somerset NHS Foundation Trust, Taunton.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Litchfield', 'Affiliation': 'Institute of Applied Health Research, University of Birmingham, Birmingham.'}, {'ForeName': 'R C', 'Initials': 'RC', 'LastName': 'Andrews', 'Affiliation': 'Department of Diabetes, Taunton and Somerset NHS Foundation Trust, Taunton.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Diabetic medicine : a journal of the British Diabetic Association,['10.1111/dme.14064'] 3088,32009288,Impact of dose-escalation schemes and drug discontinuation on weight loss outcomes with liraglutide 3.0 mg: A model-based approach.,"AIMS To investigate the impact on weight loss of the treatment changes in overweight or obese people that may be needed in case of gastrointestinal (GI) tolerability issues during escalation of the glucagon-like peptide-1 analogue liraglutide. MATERIALS AND METHODS The individual longitudinal body weight data from the main trial periods of three phase II/III trials in overweight or obese patients (56-week treatment with once-daily liraglutide 1.2, 1.8, 2.4 or 3.0 mg or placebo, n = 4952) were analysed using a non-linear mixed-effect modelling approach. Individual pharmacokinetic profiles were derived based on published pharmacokinetic models. Baseline body weight, baseline glycated haemoglobin (HbA1c), age, gender, diabetes status (no diabetes, prediabetes or type 2 diabetes), race and trial region were investigated as covariates. As a form of external validation, the model was used to predict the weight regain after treatment cessation at week 56 (data not included in model development). RESULTS A pharmacokinetic/pharmacodynamic model provided an adequate description of the weight loss trajectories for all studied doses. Gender and diabetes status were identified as the most influential covariates, and an underlying seasonal weight fluctuation was identified. Slower than that recommended, one-week dose-escalation algorithms led up to 2 weeks slower initial weight loss but similar long-term weight loss trajectories. CONCLUSIONS The relationship between liraglutide systemic exposure and weight loss was successfully established in overweight or obese people. The model could predict the time course of weight regain after treatment cessation and suggests that GI tolerability can be mitigated by slower escalation with only minor impact on the weight loss trajectory.",2020,The model could predict the time course of weight regain after treatment cessation and suggests that GI tolerability can be mitigated by slower escalation with only minor impact on the weight loss trajectory.,"['overweight or obese people', 'overweight or obese patients (56-week treatment with once-daily liraglutide 1.2, 1.8, 2.4 or 3.0\u2009mg or placebo, n = 4952']",['liraglutide'],"['weight regain', 'weight loss', 'weight loss trajectories', 'initial weight loss', 'weight loss outcomes', 'Baseline body weight, baseline glycated haemoglobin (HbA1c), age, gender, diabetes status (no diabetes, prediabetes or type 2 diabetes']","[{'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}, {'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C4068880', 'cui_str': 'One point two'}, {'cui': 'C4068742', 'cui_str': '1.8'}, {'cui': 'C4517631', 'cui_str': '2.4 (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C1456408', 'cui_str': 'liraglutide'}]","[{'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C4704807', 'cui_str': 'Weight Loss Trajectory'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0362046', 'cui_str': 'Prediabetes'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}]",4952.0,0.0321118,The model could predict the time course of weight regain after treatment cessation and suggests that GI tolerability can be mitigated by slower escalation with only minor impact on the weight loss trajectory.,"[{'ForeName': 'Theodoros', 'Initials': 'T', 'LastName': 'Papathanasiou', 'Affiliation': 'Novo Nordisk A/S, Quantitative Clinical Pharmacology, Søborg, Denmark.'}, {'ForeName': 'Anders', 'Initials': 'A', 'LastName': 'Strathe', 'Affiliation': 'Novo Nordisk A/S, Quantitative Clinical Pharmacology, Søborg, Denmark.'}, {'ForeName': 'Henrik', 'Initials': 'H', 'LastName': 'Agersø', 'Affiliation': 'Novo Nordisk A/S, Quantitative Clinical Pharmacology, Søborg, Denmark.'}, {'ForeName': 'Trine Meldgaard', 'Initials': 'TM', 'LastName': 'Lund', 'Affiliation': 'Department of Drug Design and Pharmacology, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Rune Viig', 'Initials': 'RV', 'LastName': 'Overgaard', 'Affiliation': 'Novo Nordisk A/S, Quantitative Clinical Pharmacology, Søborg, Denmark.'}]","Diabetes, obesity & metabolism",['10.1111/dom.13985'] 3089,31993789,Prone single-position extreme lateral interbody fusion (Pro-XLIF): preliminary results.,"BACKGROUND Single-position options for combined anterior and posterior fusion in the lumbar spine have been suggested to reduce the surgical time and improve the efficiency of operating room. Previous reports have focused on lateral decubitus single-position surgery. The goal of this study is to describe and evaluate the feasibility and safety of prone single-position extreme lateral interbody fusion (XLIF) with posterior fixation. METHODS Design Pilot prospective non-randomized controlled study. Seven patients who underwent prone single-position XLIF and posterior fixation were evaluated (Pro-XLIF). A control group (Std-XLIF) was composed of ten patients who underwent XLIF in lateral decubitus and posterior fixation in prone position. All patients underwent interbody XLIF fusion at one level and posterior procedures at one or more levels. Duration of surgery, blood loss, complications, X-ray use and clinical outcomes were recorded. RESULTS No major complications were observed in either group. Oswestry Disability Index, back pain and leg pain were improved in the Pro-XLIF group from 48.5, 7.7 and 8.5 to 14.5, 1.71 and 2.71, respectively, and in the Std-XLIF group from 50.8, 5.7 and 7.2 to 22.5, 3.7 and 2.5. The Pro-XLIF group had a longer time of preparation before incision (39 vs 26 min, ns), equal duration of the anterior procedure (65 vs 59 min, ns), shorter duration of surgery (133 vs 182 min, ns) and longer X-ray exposure time (102 vs 92 s, ns). The surgical technique is described. CONCLUSIONS Prone single-position XLIF is feasible and safe. In this preliminary report, the results are comparable to the standard technique. These slides can be retrieved under Electronic Supplementary Material.",2020,"The Pro-XLIF group had a longer time of preparation before incision (39 vs 26 min, ns), equal duration of the anterior procedure (65 vs 59 min, ns), shorter duration of surgery (133 vs 182 min, ns) and longer X-ray exposure time (102 vs 92 s, ns).",[],"['prone single-position extreme lateral interbody fusion (XLIF) with posterior fixation', 'Prone single-position extreme lateral interbody fusion (Pro-XLIF', 'XLIF']","['shorter duration of surgery', 'Duration of surgery, blood loss, complications, X-ray use and clinical outcomes', 'longer X-ray exposure time', 'major complications', 'longer time of preparation before incision', 'Oswestry Disability Index, back pain and leg pain']",[],"[{'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C1561964', 'cui_str': 'Patient Positioning'}, {'cui': 'C0205403', 'cui_str': 'Extreme (qualifier value)'}, {'cui': 'C0205093', 'cui_str': 'Lateral (qualifier value)'}, {'cui': 'C1293131', 'cui_str': 'Fusion procedure (procedure)'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0185023', 'cui_str': 'pexy'}]","[{'cui': 'C0439593', 'cui_str': 'Short duration (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0034571', 'cui_str': 'radiography'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0184898', 'cui_str': 'Incision - attribute'}, {'cui': 'C0451360', 'cui_str': 'Oswestry disability index (assessment scale)'}, {'cui': 'C0004604', 'cui_str': 'Backache'}, {'cui': 'C0023222', 'cui_str': 'Pain in lower limb (finding)'}]",7.0,0.0424682,"The Pro-XLIF group had a longer time of preparation before incision (39 vs 26 min, ns), equal duration of the anterior procedure (65 vs 59 min, ns), shorter duration of surgery (133 vs 182 min, ns) and longer X-ray exposure time (102 vs 92 s, ns).","[{'ForeName': 'Claudio', 'Initials': 'C', 'LastName': 'Lamartina', 'Affiliation': 'IRCCS Istituto Ortopedico Galeazzi, Milan, Italy.'}, {'ForeName': 'Pedro', 'Initials': 'P', 'LastName': 'Berjano', 'Affiliation': 'IRCCS Istituto Ortopedico Galeazzi, Milan, Italy. pberjano@gmail.com.'}]","European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society",['10.1007/s00586-020-06303-z'] 3090,32065514,"Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of a Liver-Targeting Acetyl-CoA Carboxylase Inhibitor (PF-05221304): A Three-Part Randomized Phase 1 Study.","PF-05221304 is a liver-targeted inhibitor of acetyl-CoA carboxylase, an enzyme that catalyzes the first committed step in de novo lipogenesis (DNL). This first-in-human study investigated safety/tolerability and pharmacokinetics of single and multiple ascending oral PF-05221304 doses, and fructose-stimulated DNL inhibition with repeated oral doses. Healthy subjects (n = 96) received single (1-240 mg) or repeated (2-200 mg daily) doses for 14 days or single 100-mg doses with and without food. PF-05221304 was well tolerated at all doses. Repeated PF-05221304 doses inhibited hepatic DNL in a dose-dependent manner, with near-complete inhibition seen at higher doses. With doses yielding ≥90% DNL inhibition, asymptomatic increases in fasting/postprandial serum triglyceride levels (≥40 mg/day) and declines in platelet count (≥60 mg/day) occurred; these were not observed at ≤80% DNL inhibition. Steady-state pharmacokinetics generally increased dose-proportionally, with a half-life of 14-18 hours and a minimal food effect on plasma exposure. The observed safety and tolerability, pharmacokinetics, and pharmacodynamics support the continued evaluation of PF-05221304 for the treatment of nonalcoholic steatohepatitis.",2020,"Repeated PF-05221304 doses inhibited hepatic DNL in a dose-dependent manner, with near-complete inhibition seen at higher doses.",['Healthy subjects (n\xa0=\xa096'],['Liver-Targeting Acetyl-CoA Carboxylase Inhibitor (PF-05221304'],"['tolerated', 'Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics', 'safety and tolerability, pharmacokinetics, and pharmacodynamics', 'fasting/postprandial serum triglyceride levels', 'platelet count']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C0001022', 'cui_str': 'Acetyl Coenzyme A Carboxylase'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0376674', 'cui_str': 'Postcibal Period'}, {'cui': 'C0542495', 'cui_str': 'Measurement of serum triglyceride level'}, {'cui': 'C1287267', 'cui_str': 'Finding of platelet count (finding)'}]",,0.0259406,"Repeated PF-05221304 doses inhibited hepatic DNL in a dose-dependent manner, with near-complete inhibition seen at higher doses.","[{'ForeName': 'Arthur', 'Initials': 'A', 'LastName': 'Bergman', 'Affiliation': 'Pfizer Inc, Early Clinical Development, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Santos', 'Initials': 'S', 'LastName': 'Carvajal-Gonzalez', 'Affiliation': 'Pfizer Inc, Early Clinical Development, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Sanela', 'Initials': 'S', 'LastName': 'Tarabar', 'Affiliation': 'Pfizer Inc, Clinical Research Unit, New Haven, Connecticut, USA.'}, {'ForeName': 'Aditi R', 'Initials': 'AR', 'LastName': 'Saxena', 'Affiliation': 'Pfizer Inc, Internal Medicine Research Unit, Cambridge, Massachusetts, USA.'}, {'ForeName': 'William P', 'Initials': 'WP', 'LastName': 'Esler', 'Affiliation': 'Pfizer Inc, Internal Medicine Research Unit, Cambridge, Massachusetts, USA.'}, {'ForeName': 'Neeta B', 'Initials': 'NB', 'LastName': 'Amin', 'Affiliation': 'Pfizer Inc, Internal Medicine Research Unit, Cambridge, Massachusetts, USA.'}]",Clinical pharmacology in drug development,['10.1002/cpdd.782'] 3091,32069463,Nurse-Guided Internet-Delivered Cognitive Behavioral Therapy for Insomnia in General Practice: Results from a Pragmatic Randomized Clinical Trial.,"INTRODUCTION Guidelines recommend cognitive behavioral therapy for insomnia (CBT-I) as the first line of treatment for insomnia in general practice, but CBT-I is rarely available. Nurse-guided Internet-delivered CBT-I might be a solution to improve access to care. OBJECTIVE We aimed to determine the effectiveness of nurse-guided Internet-delivered CBT-I (I-CBT-I) on insomnia severity experienced by patients in general practice. METHODS Nurse-guided I-CBT-I (""i-Sleep"") was compared to care-as-usual (and I-CBT-I after 6 months) in 15 participating general practices among 134 patients (≥18 years old) with clinical insomnia symptoms. Assessments took place at 8, 26 and 52 weeks. Primary outcome was self-reported insomnia severity (Insomnia Severity Index) at 8 weeks. Secondary outcomes were sleep diary indices, depression and anxiety symptoms (Hospital Anxiety and Depression Scale), fatigue, daytime consequences of insomnia, sleep medication and adverse events. RESULTS Two thirds of the 69 intervention patients (n = 47; 68%) completed the whole intervention. At the posttest examination, there were large significant effects for insomnia severity (Cohen's d =1.66), several sleep diary variables (wake after sleep onset, number of awakenings, terminal wakefulness, sleep efficiency, sleep quality) and depression. At 26 weeks there were still significant effects on insomnia severity (d = 1.02) and on total sleep time and sleep efficiency. No significant effects were observed for anxiety, fatigue, daily functioning or sleep medication. No adverse events were reported. CONCLUSIONS Nurse-guided I-CBT-I effectively reduces insomnia severity among general practice patients. I-CBT-I enables general practitioners to offer effective insomnia care in accordance with the clinical guidelines.",2020,At 26 weeks there were still significant effects on insomnia severity (d = 1.02) and on total sleep time and sleep efficiency.,"['15 participating general practices among 134 patients (≥18 years old) with clinical insomnia symptoms', 'general practice patients', 'Two thirds of the 69 intervention patients (n = 47; 68%) completed the whole intervention', 'insomnia severity experienced by patients in general practice']","['Nurse-Guided Internet-Delivered Cognitive Behavioral Therapy', 'nurse-guided Internet-delivered CBT-I (I-CBT-I', 'cognitive behavioral therapy', 'Nurse-guided I-CBT-I (""i-Sleep']","['total sleep time and sleep efficiency', 'several sleep diary variables (wake after sleep onset, number of awakenings, terminal wakefulness, sleep efficiency, sleep quality) and depression', 'self-reported insomnia severity (Insomnia Severity Index', 'adverse events', 'sleep diary indices, depression and anxiety symptoms (Hospital Anxiety and Depression Scale), fatigue, daytime consequences of insomnia, sleep medication and adverse events', 'anxiety, fatigue, daily functioning or sleep medication', 'insomnia severity']","[{'cui': 'C0086343', 'cui_str': 'General Practice'}, {'cui': 'C4517565', 'cui_str': 'One hundred and thirty-four'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205437', 'cui_str': 'Third (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}]","[{'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0376660', 'cui_str': 'Diary'}, {'cui': 'C0439828', 'cui_str': 'Variable (qualifier value)'}, {'cui': 'C0442696', 'cui_str': 'Waking (observable entity)'}, {'cui': 'C1299997', 'cui_str': 'Onsets'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1720052', 'cui_str': 'Awakening'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0043012', 'cui_str': 'Wakefulnesses'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C4520529', 'cui_str': 'Insomnia severity index (assessment scale)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0451221', 'cui_str': 'Hospital anxiety and depression scale (assessment scale)'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0332169', 'cui_str': 'Daytime (qualifier value)'}, {'cui': 'C0686907', 'cui_str': 'Consequence of (contextual qualifier) (qualifier value)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}]",,0.0459295,At 26 weeks there were still significant effects on insomnia severity (d = 1.02) and on total sleep time and sleep efficiency.,"[{'ForeName': 'Tanja', 'Initials': 'T', 'LastName': 'Van der Zweerde', 'Affiliation': 'Department of Clinical Psychology, Amsterdam Public Health Research Institute, Vrije Universiteit, Amsterdam, The Netherlands, t.vander.zweerde@vu.nl.'}, {'ForeName': 'Jaap', 'Initials': 'J', 'LastName': 'Lancee', 'Affiliation': 'Department of Clinical Psychology, University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Pauline', 'Initials': 'P', 'LastName': 'Slottje', 'Affiliation': 'Department of General Practice and Elderly Care, Academic Network of General Practice (ANH), Amsterdam Public Health Research Institute, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Judith E', 'Initials': 'JE', 'LastName': 'Bosmans', 'Affiliation': 'Department of Health Sciences, Faculty of Science, Amsterdam Public Health Research Institute, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Eus J W', 'Initials': 'EJW', 'LastName': 'Van Someren', 'Affiliation': 'Department of Sleep and Cognition, Netherlands Institute for Neuroscience, an Institute of the Royal Netherlands Academy of Arts and Sciences, Amsterdam, The Netherlands.'}, {'ForeName': 'Annemieke', 'Initials': 'A', 'LastName': 'van Straten', 'Affiliation': 'Department of Clinical Psychology, Amsterdam Public Health Research Institute, Vrije Universiteit, Amsterdam, The Netherlands.'}]",Psychotherapy and psychosomatics,['10.1159/000505600'] 3092,32058364,"Effects of a Multi-ingredient Beverage on Recovery of Contractile Properties, Performance, and Muscle Soreness After Hard Resistance Training Sessions.","Naclerio, F, Larumbe-Zabala, E, Cooper, K, and Seijo, M. Effects of a multi-ingredient beverage on recovery of contractile properties, performance, and muscle soreness after hard resistance training sessions. J Strength Cond Res 34(7): 1884-1893, 2020-Carbohydrate-protein-based supplements have been proposed for maximizing postexercise recovery. This study compared the effects of postworkout supplementation ingesting a multi-ingredient (MTN) vs. carbohydrate alone (CHO) on the recovery of muscle function and perceived of delayed onset of muscle soreness (DOMS) after hard resistance workouts. In a double-blinded, crossover design, 10 resistance trained men (26.9 ± 7.4 years) performed 2 identical 5-day intervention periods while ingesting either MTN or CHO. The subjects performed one workout per day during the first 3 days. Thereafter, they were assessed 1, 24, and 48 hours after the completion of the third workout session. Primary outcome was tensiomyography (muscle displacement [Dm], contraction time [Tc], and contraction velocity [Vc]) of the vastus medialis (VM) and biceps femoris long head (BFLH). Secondary outcomes were performance and DOMS. At 24 hours, both conditions decreased (p < 0.05) Dm (MTN -1.71 ± 1.8, CHO -1.58 ± 1.46 mm) and Vc (MTN -0.03 ± 0.03, CHO 0.03 ± 0.04 m·s) in the VM. At 48 hours, all tensiomyography variables were recovered under the MTN while remained depressed (p < 0.01) in CHO (VM, Dm 1.61 ± 1.60, Vc -0.04 ± 0.04 m·s; BFLH, Dm 1.54 ± 1.52, Vc -0.02 ± 0.02 m·s). Vertical jump performance decreased in CHO, but not in MTN. Although both conditions decreased upper-body strength and power at 1 hour, values returned to baseline in 24 hours for MTM while needed 48 hours in CHO. DOMS similarly increased at both 24 and 48 hours in both conditions. Compared with the ingestion of only carbohydrates, postworkout multi-ingredient supplementation seems to hasten recovery of muscular contractile properties and performance without attenuating DOMS after hard resistance workouts.",2020,"At 24 hours, both conditions decreased (p < 0.05)",['10 resistance trained men (26.9 ± 7.4 years'],"['2020-Carbohydrate-protein-based supplements', 'performed 2 identical 5-day intervention periods while ingesting either MTN or CHO', 'Multi-ingredient Beverage', 'J Strength Cond Res XX(X', 'postworkout supplementation ingesting a multi-ingredient (MTN) vs. carbohydrate alone (CHO']","['tensiomyography (muscle displacement [Dm], contraction time [Tc], and contraction velocity [Vc]) of the vastus medialis (VM) and biceps femoris long head (BFLH', 'performance and DOMS', 'recovery of contractile properties, performance, and muscle soreness', 'Vertical jump performance', 'Recovery of Contractile Properties, Performance, and Muscle Soreness', 'DOMS', 'upper-body strength and power']","[{'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C4517858', 'cui_str': '7.4'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C3541972', 'cui_str': 'Carbohydrate nutrients'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0205280', 'cui_str': 'Identical (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C3266262', 'cui_str': 'Multi'}, {'cui': 'C0005329', 'cui_str': 'Beverages'}]","[{'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0456080', 'cui_str': 'Displacement (attribute)'}, {'cui': 'C1140999', 'cui_str': 'Contraction (finding)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C0224445', 'cui_str': 'Vastus Medialis'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0018670', 'cui_str': 'Head'}, {'cui': 'C0013007', 'cui_str': '1-(2,5-Dimethoxy-4-Methylphenyl)-2-Aminopropane'}, {'cui': 'C0871161', 'cui_str': 'Property (attribute)'}, {'cui': 'C0231528', 'cui_str': 'Muscle Pain'}, {'cui': 'C0205128', 'cui_str': 'Vertical (qualifier value)'}, {'cui': 'C0560453', 'cui_str': 'Does jump (finding)'}, {'cui': 'C1268087', 'cui_str': 'Upper body'}]",,0.239214,"At 24 hours, both conditions decreased (p < 0.05)","[{'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Naclerio', 'Affiliation': 'Department of Sport Science and Physical Education, School of Human Sciences, University of Greenwich, London, United Kingdom.'}, {'ForeName': 'Eneko', 'Initials': 'E', 'LastName': 'Larumbe-Zabala', 'Affiliation': 'Clinical Research Institute, Texas Tech University Health Sciences Center, Lubbock, Texas.'}, {'ForeName': 'Kelly', 'Initials': 'K', 'LastName': 'Cooper', 'Affiliation': 'Department of Sport Science and Physical Education, School of Human Sciences, University of Greenwich, London, United Kingdom.'}, {'ForeName': 'Marco', 'Initials': 'M', 'LastName': 'Seijo', 'Affiliation': 'Department of Sport Science and Physical Education, School of Human Sciences, University of Greenwich, London, United Kingdom.'}]",Journal of strength and conditioning research,['10.1519/JSC.0000000000003397'] 3093,32048255,Influence of obesity on pharmacokinetics and analgesic effect of ketoprofen administered intravenously to patients after laparoscopic cholecystectomy.,"BACKGROUND Ketoprofen is an analgesic drug commonly applied in the postoperative period, e.g., to patients after laparoscopic cholecystectomy. Many patients who undergo this procedure are obese. As pathophysiological changes are observed in obesity, the efficacy of ketoprofen may be altered in this group of patients. The aim of the study was to compare the pharmacokinetic parameters and analgesic effect of ketoprofen administered to obese and non-obese patients after laparoscopic cholecystectomy. METHODS The study was conducted on 41 patients after laparoscopic cholecystectomy, who were divided into two groups: obese (n = 21) and non-obese (n = 20). Ketoprofen was administered intravenously at a dose of 100 mg. Plasma ketoprofen concentrations were measured by means of validated high-performance liquid chromatography with ultraviolet detection. The pharmacokinetic parameters of the drug were calculated using the non-compartmental method. Additionally, pain intensity was assessed during the study using NRS scale. RESULTS The obese patients had significantly lower AUC 0-∞ (1.4-fold), AUMC 0-t (1.8-fold), AUMC 0-∞ (3.2-fold), MRT 0-t (1.4-fold), MRT 0-∞ (2.3-fold), t 0.5 (2.3-fold) and V z /kg (2.3-fold) and higher k el (2.2-fold) than the non-obese group. Moreover, 4 h and 6 h after the administration of the drug, pain intensity was significantly higher in the obese patients. CONCLUSIONS The drug was eliminated faster and the analgesic effect of ketoprofen in the obese patients was decreased as compared with the non-obese subjects. However, pain intensity did not increase to the level, which required additional analgesic treatment. Therefore, it seems that dosage adjustment of intravenous ketoprofen is not necessary in obese patients.",2020,"Moreover, 4 h and 6 h after the administration of the drug, pain intensity was significantly higher in the obese patients. ","['41 patients after laparoscopic cholecystectomy, who were divided into two groups: obese (n\u2009=\u200921) and non-obese (n\u2009=\u200920', 'obese patients', 'obese and non-obese patients after laparoscopic cholecystectomy', 'patients after laparoscopic cholecystectomy']","['Ketoprofen', 'ketoprofen']","['Plasma ketoprofen concentrations', 'pain intensity', 'pharmacokinetic parameters and analgesic effect', 'AUC 0-∞ (1.4-fold), AUMC 0-t (1.8-fold), AUMC 0-∞ (3.2-fold), MRT 0-t', 'analgesic effect']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0162522', 'cui_str': 'Cholecystectomy, Celioscopic'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}]","[{'cui': 'C0022635', 'cui_str': 'Ketoprofen'}]","[{'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0022635', 'cui_str': 'Ketoprofen'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0948482', 'cui_str': 'Analgesic effect'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C4517503', 'cui_str': '1.4 (qualifier value)'}, {'cui': 'C0185026', 'cui_str': 'Plication - action (qualifier value)'}, {'cui': 'C4068742', 'cui_str': '1.8'}, {'cui': 'C4517687', 'cui_str': '3.2'}]",41.0,0.0283475,"Moreover, 4 h and 6 h after the administration of the drug, pain intensity was significantly higher in the obese patients. ","[{'ForeName': 'Joanna', 'Initials': 'J', 'LastName': 'Porażka', 'Affiliation': 'Department of Clinical Pharmacy and Biopharmacy, Poznań University of Medical Sciences, ul. Św. Marii Magdaleny 14, 61-861, Poznan, Poland. joanna.porazka@gmail.com.'}, {'ForeName': 'Edyta', 'Initials': 'E', 'LastName': 'Szałek', 'Affiliation': 'Department of Clinical Pharmacy and Biopharmacy, Poznań University of Medical Sciences, ul. Św. Marii Magdaleny 14, 61-861, Poznan, Poland.'}, {'ForeName': 'Wojciech', 'Initials': 'W', 'LastName': 'Żółtaszek', 'Affiliation': 'Surgery Department, Public Health Care Centre in Kępno, ul. Szpitalna 7, 63-600, Kępno, Poland.'}, {'ForeName': 'Tomasz', 'Initials': 'T', 'LastName': 'Grabowski', 'Affiliation': 'Polpharma Biologics, ul. Trzy lipy 3, 80-172, Gdańsk, Poland.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Wolc', 'Affiliation': 'Department of Animal Science, Iowa State University, 239E Kildee Hall, Ames, IA, 50011, USA.'}, {'ForeName': 'Edmund', 'Initials': 'E', 'LastName': 'Grześkowiak', 'Affiliation': 'Department of Clinical Pharmacy and Biopharmacy, Poznań University of Medical Sciences, ul. Św. Marii Magdaleny 14, 61-861, Poznan, Poland.'}]",Pharmacological reports : PR,['10.1007/s43440-019-00042-9'] 3094,32048278,Determining the effective pre-oxygenation interval in obstetric patients using high-flow nasal oxygen and standard flow rate facemask: a biased-coin up-down sequential allocation trial.,"Using biased-coin sequential allocation, we sought to determine the effective time interval in 90% of healthy parturients to achieve a target endpoint end-tidal oxygen of ≥ 90% using standard flow rate facemask and high-flow nasal oxygen. Eighty healthy parturients were randomly assigned to standard facemask (n = 40) or high-flow nasal oxygen (n = 40) groups; half of the parturients in the high-flow nasal oxygen group also used a simple no-flow facemask to minimise air entrainment. The effective time interval for 90% of parturients to achieve the target endpoint for standard facemask was 3.6 min (95%CI 3.3-6.7 min), but could not be estimated for the high-flow nasal oxygen groups with or without an additional simple facemask, as eight minutes was insufficient to achieve the target endpoint for 55% and 92% of parturients, respectively. Furthermore, after three minutes, the target endpoint was reached by 71% in the standard facemask group vs. 0% in the high-flow nasal oxygen groups. After four minutes, the target endpoint was reached by 100% in the standard facemask, 80% in the high-flow nasal oxygen with simple facemask and 67% in the high-flow nasal oxygen groups. Beyond four minutes, there was no improvement in pre-oxygenation success using high-flow nasal oxygen. In conclusion, under the conditions of our study, the effective time interval for 90% of parturients to achieve an end-tidal oxygen ≥ 90% for standard flow rate facemask was estimated to be 3.6 min, but could not be estimated for high-flow nasal oxygen groups even after eight minutes.",2020,"Beyond four minutes, there was no improvement in pre-oxygenation success using high-flow nasal oxygen.","['obstetric patients using high', 'Eighty healthy parturients']","['standard facemask (n\xa0=\xa040) or high-flow nasal oxygen (n\xa0=\xa040) groups; half of the parturients in the high-flow nasal oxygen group also used a simple no-flow facemask to minimise air entrainment', 'flow nasal oxygen and standard flow rate facemask', 'standard flow rate facemask and high-flow nasal oxygen']","['effective time interval', 'pre-oxygenation success']","[{'cui': 'C0028773', 'cui_str': 'Obstetrics'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C3816958', 'cui_str': 'Eighty'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C4520890', 'cui_str': 'Nasal'}, {'cui': 'C0030054', 'cui_str': 'Oxygen'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0205352', 'cui_str': 'Simple (qualifier value)'}, {'cui': 'C0001861', 'cui_str': 'Air'}]","[{'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}]",,0.0489449,"Beyond four minutes, there was no improvement in pre-oxygenation success using high-flow nasal oxygen.","[{'ForeName': 'K', 'Initials': 'K', 'LastName': 'Au', 'Affiliation': ""British Columbia Women's Hospital, University of British Columbia, Vancouver, BC, Canada.""}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Shippam', 'Affiliation': ""British Columbia Women's Hospital, University of British Columbia, Vancouver, BC, Canada.""}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Taylor', 'Affiliation': ""British Columbia Women's Hospital, University of British Columbia, Vancouver, BC, Canada.""}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Albert', 'Affiliation': ""Women's Health Research Institute, Vancouver, BC, Canada.""}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Chau', 'Affiliation': ""British Columbia Women's Hospital, University of British Columbia, Vancouver, BC, Canada.""}]",Anaesthesia,['10.1111/anae.14995'] 3095,32049562,Effect of inspiratory resistive training on diaphragm shear modulus and accessory inspiratory muscle activation.,"This study aimed to elucidate changes in diaphragm and accessory inspiratory muscle (sternocleidomastoid (SCM) muscle and intercostal muscle (IC)) function after a 6-week training program. Nineteen male elite collegiate swimmers were assigned to either a control group ( n = 9) or training group ( n = 10). The subjects in the training group performed 30 maximum inspirations at a load resistance of 50% of maximum inspiratory mouth pressure (PImax) using an inspiratory muscle training device. These were conducted twice per day and 6 days per week. At baseline and after 6 weeks, PImax, shear modulus of the diaphragm, and electromyograms (EMG) of the SCM and IC during a maximal inspiratory maneuver were evaluated. Relative change in PImax was greater in the training group than in controls. The shear modulus during a PImax maneuver had increased significantly in both groups after 6 weeks. EMG amplitudes of the SCM increased in the training group after 6 weeks, but not in the control group. EMG amplitudes of the IC did not change after 6 weeks in either group. These results suggest that 6-week inspiratory resistive training significantly improves the activation of the SCM, which could be one of the major mechanisms behind increases in inspiratory muscle strength after resistive training. Novelty Six-week inspiratory resistive training increased diaphragm stiffness during maximal inspiration maneuver. Six-week inspiratory resistive training increased electromyogram amplitudes of the sternocleidomastoid during maximal inspiration maneuver.",2020,Six-week inspiratory resistive training increased electromyogram amplitudes of the sternocleidomastoid during maximal inspiration maneuver.,['Nineteen male elite collegiate swimmers'],"['Six-week inspiratory resistive training', 'diaphragm and accessory inspiratory muscle (sternocleidomastoid [SCM', 'control group (n=9) or training group', 'inspiratory resistive training', 'training group performed 30 maximum inspirations at a load resistance of 50% of maximum inspiratory mouth pressure (PImax) using an inspiratory muscle training device']","['electromyogram amplitudes', 'PImax, shear modulus of the diaphragm, and electromyograms (EMG) of the SCM and IC', 'Relative change in PImax', 'inspiratory muscle strength', 'diaphragm stiffness', 'EMG amplitudes', 'diaphragm shear modulus and accessory inspiratory muscle activation', 'EMG amplitudes of the SCM']","[{'cui': 'C0450337', 'cui_str': '19 (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0450068', 'cui_str': 'Swimmer (person)'}]","[{'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0004048', 'cui_str': 'Inhalation'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0011980', 'cui_str': 'Respiratory Diaphragm'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0230028', 'cui_str': 'Structure of oral region of face'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0454511', 'cui_str': 'Inspiratory muscle training (regime/therapy)'}, {'cui': 'C0220819', 'cui_str': 'devices'}]","[{'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C0011980', 'cui_str': 'Respiratory Diaphragm'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0004048', 'cui_str': 'Inhalation'}, {'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0427008', 'cui_str': 'Stiffness (finding)'}, {'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0429340', 'cui_str': 'EMG amplitude'}]",19.0,0.0129567,Six-week inspiratory resistive training increased electromyogram amplitudes of the sternocleidomastoid during maximal inspiration maneuver.,"[{'ForeName': 'Ryosuke', 'Initials': 'R', 'LastName': 'Ando', 'Affiliation': 'Department of Sports Research, Japan Institute of Sports Sciences, 3-15-1, Nishigaoka, Kita-ku, Tokyo, 115-0056, Japan.'}, {'ForeName': 'Toshiyuki', 'Initials': 'T', 'LastName': 'Ohya', 'Affiliation': 'School of Health and Sport Sciences, Chukyo University, Aichi, Japan.'}, {'ForeName': 'Kenta', 'Initials': 'K', 'LastName': 'Kusanagi', 'Affiliation': 'School of Health and Sport Sciences, Chukyo University, Aichi, Japan.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Koizumi', 'Affiliation': 'School of Health and Sport Sciences, Chukyo University, Aichi, Japan.'}, {'ForeName': 'Hayato', 'Initials': 'H', 'LastName': 'Ohnuma', 'Affiliation': 'Department of Sports Research, Japan Institute of Sports Sciences, 3-15-1, Nishigaoka, Kita-ku, Tokyo, 115-0056, Japan.'}, {'ForeName': 'Keisho', 'Initials': 'K', 'LastName': 'Katayama', 'Affiliation': 'Research Center of Health, Physical Fitness and Sports, Nagoya University, Nagoya, Japan.'}, {'ForeName': 'Yasuhiro', 'Initials': 'Y', 'LastName': 'Suzuki', 'Affiliation': 'Department of Sports Research, Japan Institute of Sports Sciences, 3-15-1, Nishigaoka, Kita-ku, Tokyo, 115-0056, Japan.'}]","Applied physiology, nutrition, and metabolism = Physiologie appliquee, nutrition et metabolisme",['10.1139/apnm-2019-0906'] 3096,31351869,"Palbociclib and cetuximab in platinum-resistant and in cetuximab-resistant human papillomavirus-unrelated head and neck cancer: a multicentre, multigroup, phase 2 trial.","BACKGROUND Most head and neck squamous-cell carcinomas (HNSCCs) are driven by p16 INK4A inactivation and cyclin D1 overexpression that results in hyperactivation of cyclin-dependent kinase 4 and 6 (CDK4/6), rather than by the human papillomavirus (HPV). Deregulated cyclin D1 expression also causes resistance to EGFR inhibitors. We previously reported that palbociclib (a selective CDK4/6 inhibitor) given with cetuximab (an EGFR inhibitor) was safe. The aim of this study was to establish the proportion of patients achieving an objective response with palbociclib and cetuximab in recurrent or metastatic HNSCC. METHODS We did a multicentre, multigroup, phase 2 trial to evaluate the activity of palbociclib and cetuximab in platinum-resistant (group 1) and cetuximab-resistant (group 2) HPV-unrelated HNSCC. The study was done across eight university sites in the USA. Eligibility required measurable disease (according to Response Evaluation Criteria in Solid Tumors, version 1·1 [RECIST 1·1]), Eastern Cooperative Oncology Group (ECOG) performance status of 0-2, age of 18 years or older, and disease progression on platinum but cetuximab-naive (group 1) or disease progression on cetuximab (group 2). All patients received palbociclib orally (125 mg/day, on days 1-21) and intravenous cetuximab (400 mg/m 2 on cycle one, day 1, then 250 mg/m 2 once per week) in 28-day cycles. The primary endpoint was objective response (complete responses and partial responses per RECIST 1·1). Analyses were done per protocol. This trial was registered with ClinicalTrials.gov, NCT02101034, and is ongoing, but both groups are closed to accrual. FINDINGS Between Oct 19, 2015, and Nov 7, 2018, 62 patients were enrolled onto the trial: 30 patients were enrolled in group 1 and 32 in group 2. Median follow-up was 5·4 months (IQR 4·4-12·1) for group 1 and 5·5 months (4·3-8·3) for group 2. In group 1, of 28 evaluable patients, an objective response was achieved by 11 (39%; 95% CI 22-59). In group 2, of 27 evaluable patients, an objective response was achieved by five (19%; 6-38) in group 2. The most common grade 3-4 palbociclib-related adverse event was neutropenia (in 21 [34%] of 62 patients). No treatment-related deaths occurred. INTERPRETATION In patients with platinum-resistant or cetuximab-resistant HPV-unrelated HNSCC, palbociclib and cetuximab results in promising activity outcomes. Further studies of CDK4/6 inhibitors are warranted in HPV-unrelated HNSCC. FUNDING Pfizer.",2019,Median follow-up was 5·4 months (IQR 4·4-12·1) for group 1 and 5·5 months,"['Most head and neck squamous-cell carcinomas (HNSCCs', 'Eastern Cooperative Oncology Group (ECOG) performance status of 0-2, age of 18 years or older, and disease progression on platinum but cetuximab-naive (group 1) or disease progression on cetuximab (group 2', '30 patients were enrolled in group 1 and 32 in group 2', 'patients with platinum-resistant or cetuximab-resistant HPV-unrelated', 'in recurrent or metastatic HNSCC', 'resistant human papillomavirus-unrelated head and neck cancer', 'Between Oct 19, 2015, and Nov 7, 2018, 62 patients were enrolled onto the trial']","['Palbociclib and cetuximab', 'palbociclib and cetuximab', 'cetuximab', 'HNSCC, palbociclib and cetuximab', 'palbociclib orally', 'CDK4/6 inhibitors', 'palbociclib and cetuximab in platinum-resistant (group 1) and cetuximab-resistant (group 2) HPV-unrelated HNSCC', 'intravenous cetuximab']","['neutropenia', 'objective response', 'objective response (complete responses and partial responses per RECIST 1·1']","[{'cui': 'C0018670', 'cui_str': 'Head'}, {'cui': 'C0027536', 'cui_str': 'Necking (finding)'}, {'cui': 'C0221910', 'cui_str': 'Squamous Cells'}, {'cui': 'C1520224', 'cui_str': 'Eastern Cooperative Oncology Group performance status'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0242656', 'cui_str': 'Disease Progression'}, {'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C0995188', 'cui_str': 'cetuximab'}, {'cui': 'C0441861', 'cui_str': 'Group 1 (qualifier value)'}, {'cui': 'C0441865', 'cui_str': 'Group 2 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332325', 'cui_str': 'Resistant (qualifier value)'}, {'cui': 'C0445356', 'cui_str': 'Unrelated (finding)'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C0278996', 'cui_str': 'Cancer of Head and Neck'}]","[{'cui': 'C3853822', 'cui_str': 'palbociclib'}, {'cui': 'C0995188', 'cui_str': 'cetuximab'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C0332325', 'cui_str': 'Resistant (qualifier value)'}, {'cui': 'C0441861', 'cui_str': 'Group 1 (qualifier value)'}, {'cui': 'C0441865', 'cui_str': 'Group 2 (qualifier value)'}, {'cui': 'C0445356', 'cui_str': 'Unrelated (finding)'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}]","[{'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C1709926', 'cui_str': 'RECIST'}]",62.0,0.0545373,Median follow-up was 5·4 months (IQR 4·4-12·1) for group 1 and 5·5 months,"[{'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Adkins', 'Affiliation': 'Division of Medical Oncology, Washington University School of Medicine, St Louis, MO, USA; Alvin J Siteman Cancer Center, Washington University School of Medicine, St Louis, MO, USA. Electronic address: dadkins@wustl.edu.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Ley', 'Affiliation': 'Division of Medical Oncology, Washington University School of Medicine, St Louis, MO, USA.'}, {'ForeName': 'Prakash', 'Initials': 'P', 'LastName': 'Neupane', 'Affiliation': 'Division of Oncology, University of Kansas School of Medicine, Kansas City, KS, USA.'}, {'ForeName': 'Francis', 'Initials': 'F', 'LastName': 'Worden', 'Affiliation': 'Department of Medicine, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Assuntina G', 'Initials': 'AG', 'LastName': 'Sacco', 'Affiliation': 'University of California San Diego Moores Cancer Center, La Jolla, CA, USA.'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Palka', 'Affiliation': 'Division of Medical Oncology, Washington University School of Medicine, St Louis, MO, USA; Department of Medicine, St Louis University, St Louis, MO, USA.'}, {'ForeName': 'Juneko E', 'Initials': 'JE', 'LastName': 'Grilley-Olson', 'Affiliation': 'Department of Medicine, Division of Hematology-Oncology, and Lineberger Comprehensive Cancer Center, University of North Carolina School of Medicine, Chapel Hill, NC, USA.'}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'Maggiore', 'Affiliation': 'Department of Medicine, Wilmont Cancer Institute at the University of Rochester, Rochester, NY, USA.'}, {'ForeName': 'Noha N', 'Initials': 'NN', 'LastName': 'Salama', 'Affiliation': 'Department of Pharmaceutics and Industrial Pharmacy, Faculty of Pharmacy, Cairo University, Cairo, Egypt; Department of Pharmaceutical and Administrative Sciences, St Louis College of Pharmacy, St Louis, MO, USA.'}, {'ForeName': 'Kathryn', 'Initials': 'K', 'LastName': 'Trinkaus', 'Affiliation': 'Biostatistics Shared Resource, Washington University School of Medicine, St Louis, MO, USA.'}, {'ForeName': 'Brian A', 'Initials': 'BA', 'LastName': 'Van Tine', 'Affiliation': 'Division of Medical Oncology, Washington University School of Medicine, St Louis, MO, USA; Alvin J Siteman Cancer Center, Washington University School of Medicine, St Louis, MO, USA.'}, {'ForeName': 'Conor E', 'Initials': 'CE', 'LastName': 'Steuer', 'Affiliation': 'Winship Cancer Institute of Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Nabil F', 'Initials': 'NF', 'LastName': 'Saba', 'Affiliation': 'Winship Cancer Institute of Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Oppelt', 'Affiliation': 'Division of Medical Oncology, Washington University School of Medicine, St Louis, MO, USA; Alvin J Siteman Cancer Center, Washington University School of Medicine, St Louis, MO, USA.'}]",The Lancet. Oncology,['10.1016/S1470-2045(19)30405-X'] 3097,31984646,"Liraglutide as add-on to sodium-glucose co-transporter-2 inhibitors in patients with inadequately controlled type 2 diabetes: LIRA-ADD2SGLT2i, a 26-week, randomized, double-blind, placebo-controlled trial.","AIM To compare the effect of liraglutide or placebo added on to sodium-glucose co-transporter-2 inhibitor (SGLT2i) ± metformin on glycaemic control in patients with type 2 diabetes. MATERIALS AND METHODS Patients with type 2 diabetes on a stable SGLT2i dose ± metformin (with HbA1c 7.0%-9.5% and body mass index [BMI] ≥ 20 kg/m 2 ) were randomized 2:1 to add-on liraglutide 1.8 mg/day or placebo in this parallel, double-blind, multinational trial. Primary and confirmatory secondary endpoints were changes in HbA1c and body weight from baseline to week 26, respectively. The proportions of patients achieving HbA1c (<7.0%) targets and safety events after week 26 were also assessed. RESULTS Of 303 patients randomized (one in error), 280 completed treatment. Mean changes in HbA1c from baseline to week 26 with liraglutide (n = 202) and placebo (n = 100) were - 0.98% and - 0.30%, respectively (estimated treatment difference [ETD]: -0.68% [95% CI: -0.89, -0.48]; P < 0.001). Mean body weight changes from baseline were - 2.81 versus -1.99 kg, respectively (ETD: -0.82 kg [95% CI: -1.73, 0.09]; P = 0.077); 51.8% of liraglutide-treated patients achieved HbA1c < 7.0% versus 23.2% receiving placebo (odds ratio: 5.1 [95% CI: 2.67, 9.87]; P < 0.001). More patients treated with liraglutide reported ≥1 treatment-emergent adverse events (66.3%) versus placebo (47.0%). CONCLUSIONS Liraglutide significantly improved glycaemic control compared with placebo in patients with type 2 diabetes, insufficiently controlled with SGLT2is with/without metformin, with no unexpected safety findings.",2020,"(ETD: -0.82 kg [95% CI: -1.73, 0.09];","['303 patients randomized (one in error), 280 completed treatment', 'patients with inadequately controlled type 2 diabetes', 'Patients with type 2 diabetes on a stable SGLT2i dose ± metformin (with HbA 1c 7.0-9.5% and body mass index', 'patients with type 2 diabetes']","['liraglutide or placebo', 'liraglutide 1.8 mg/day or placebo', 'LIRA-ADD2SGLT2i', 'Liraglutide', 'liraglutide', 'placebo', 'Glucagon-like peptide-1 receptor agonists (GLP-1RAs) and sodium-glucose cotransporter-2 inhibitors (SGLT2is', 'SGLT2i±metformin']","['Mean body weight changes', 'safety events', 'changes in HbA 1c and body weight', 'Mean changes in HbA 1c', 'glycated haemoglobin (HbA 1c ) levels', '≥1 treatment-emergent adverse events', 'glycaemic control']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C4517899', 'cui_str': 'Nine point five'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}]","[{'cui': 'C1456408', 'cui_str': 'liraglutide'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4068742', 'cui_str': '1.8'}, {'cui': 'C0439422', 'cui_str': 'mg/day'}, {'cui': 'C0378073', 'cui_str': 'GLP-1 Receptor'}, {'cui': 'C0243192', 'cui_str': 'agonists'}, {'cui': 'C0017739', 'cui_str': 'Sodium-Glucose Transport Proteins'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0005911', 'cui_str': 'Body Weight Changes'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]",303.0,0.5815,"(ETD: -0.82 kg [95% CI: -1.73, 0.09];","[{'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Blonde', 'Affiliation': 'Ochsner Diabetes Clinical Research Unit, Frank Riddick Diabetes Institute, Department of Endocrinology, Ochsner Medical Center, New Orleans, Louisiana, United States.'}, {'ForeName': 'Lidia', 'Initials': 'L', 'LastName': 'Belousova', 'Affiliation': 'Almazov National Medical Research Centre, Saint-Petersburg, Russian Federation.'}, {'ForeName': 'Udi', 'Initials': 'U', 'LastName': 'Fainberg', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Pedro A', 'Initials': 'PA', 'LastName': 'Garcia-Hernandez', 'Affiliation': 'Endocrinology Service, University Hospital, Monterrey, Mexico.'}, {'ForeName': 'Sunil M', 'Initials': 'SM', 'LastName': 'Jain', 'Affiliation': 'Endocrinology, TOTALL Diabetes Hormone Institute, Indore, Madhya Pradesh, India.'}, {'ForeName': 'Margit S', 'Initials': 'MS', 'LastName': 'Kaltoft', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Ofri', 'Initials': 'O', 'LastName': 'Mosenzon', 'Affiliation': 'Diabetes Unit, Division of Internal Medicine, Hadassah Hebrew University Hospital, Jerusalem, Israel.'}, {'ForeName': 'Jalal', 'Initials': 'J', 'LastName': 'Nafach', 'Affiliation': 'Dubai Diabetes Center, Dubai Health Authority, Dubai, United Arab Emirates.'}, {'ForeName': 'Mads Sundby', 'Initials': 'MS', 'LastName': 'Palle', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Rosangela', 'Initials': 'R', 'LastName': 'Rea', 'Affiliation': 'Endocrinology and Metabolism Service (SEMPR), Universidade Federal do Paraná, Curitiba, Brazil.'}]","Diabetes, obesity & metabolism",['10.1111/dom.13978'] 3098,31776027,Impact of tetanus-diphtheria-acellular pertussis immunization during pregnancy on subsequent infant immunization seroresponses: follow-up from a large randomized placebo-controlled trial.,"BACKGROUND Pertussis immunization during pregnancy results in high pertussis antibody concentrations in young infants but may interfere with infant immune responses to post-natal immunization. METHODS This phase IV, multi-country, open-label study assessed the immunogenicity and safety of infant primary vaccination with DTaP-HepB-IPV/Hib and 13-valent pneumococcal conjugate vaccine (PCV13). Enrolled infants (6-14 weeks old) were born to mothers who were randomized to receive reduced-antigen-content diphtheria-tetanus-three-component acellular pertussis vaccine (Tdap group) or placebo (control group) during pregnancy (27 0/7 -36 6/7 weeks' gestation) with crossover immunization postpartum. All infants received 2 or 3 DTaP-HepB-IPV/Hib and PCV13 doses according to national schedules. Immunogenicity was assessed in infants pre- and 1 month post-primary vaccination. The primary objective was to assess seroprotection/vaccine response rates for DTaP-HepB-IPV/Hib antigens 1 month post-primary vaccination. RESULTS 601 infants (Tdap group: 296; control group: 305) were vaccinated. One month post-priming, seroprotection rates were 100% (diphtheria; tetanus), ≥98.5% (hepatitis B), ≥95.9% (polio) and ≥94.5% (Hib) in both groups. Vaccine response rates for pertussis antigens were significantly lower in infants whose mothers received pregnancy Tdap (37.5-77.1%) versus placebo (90.0-99.2%). Solicited and unsolicited adverse event rates were similar between groups. Serious adverse events occurred in 2.4% (Tdap group) and 5.6% (control group) of infants, none were vaccination-related. CONCLUSIONS Pertussis antibodies transferred during pregnancy may decrease the risk of pertussis infection in the first months of life but interfere with the infant's ability to produce pertussis antibodies, the clinical significance of which remains unknown. Safety and reactogenicity results were consistent with previous experience. CLINICAL TRIAL REGISTRATION ClinicalTrials.gov: NCT02422264.",2020,"One month post-priming, seroprotection rates were 100% (diphtheria; tetanus), ≥98.5% (hepatitis B), ≥95.9% (polio) and ≥94.5% (Hib) in both groups.","['young infants', '601 infants (Tdap group: 296; control group: 305) were vaccinated', 'Enrolled infants (6-14\u202fweeks old) were born to mothers who were randomized to receive']","['placebo', 'tetanus-diphtheria-acellular pertussis immunization', 'reduced-antigen-content diphtheria-tetanus-three-component acellular pertussis vaccine (Tdap group) or placebo (control group', 'DTaP-HepB-IPV/Hib and 13-valent pneumococcal conjugate vaccine (PCV13']","['Vaccine response rates', 'subsequent infant immunization seroresponses', 'Solicited and unsolicited adverse event rates', 'Safety and reactogenicity', 'seroprotection/vaccine response rates', 'Immunogenicity', 'Serious adverse events', 'seroprotection rates']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4517703', 'cui_str': 'Three hundred and five'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0012546', 'cui_str': 'Corynebacterium diphtheriae Infection'}, {'cui': 'C0042203', 'cui_str': 'Pertussis vaccination (procedure)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0003320', 'cui_str': 'Antigens'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0982332', 'cui_str': 'acellular pertussis vaccine, inactivated'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0061073', 'cui_str': 'HPhCA'}, {'cui': 'C0276240', 'cui_str': 'Infectious pustular vulvovaginitis (disorder)'}, {'cui': 'C0121772', 'cui_str': 'Haemophilus influenzae type b'}, {'cui': 'C1579319', 'cui_str': 'Streptococcus pneumoniae conjugate vaccine'}]","[{'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0020971', 'cui_str': 'Sensitization, Immunologic'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",601.0,0.228595,"One month post-priming, seroprotection rates were 100% (diphtheria; tetanus), ≥98.5% (hepatitis B), ≥95.9% (polio) and ≥94.5% (Hib) in both groups.","[{'ForeName': 'Kirsten P', 'Initials': 'KP', 'LastName': 'Perrett', 'Affiliation': ""Murdoch Children's Research Institute and Melbourne School of Population and Global Health, University of Melbourne, Melbourne, Australia. Electronic address: kirsten.perrett@rch.org.au.""}, {'ForeName': 'Scott A', 'Initials': 'SA', 'LastName': 'Halperin', 'Affiliation': 'Dalhousie University, Canadian Center for Vaccinology, Halifax, Canada. Electronic address: scott.halperin@dal.ca.'}, {'ForeName': 'Terry', 'Initials': 'T', 'LastName': 'Nolan', 'Affiliation': ""Murdoch Children's Research Institute and Melbourne School of Population and Global Health, University of Melbourne, Melbourne, Australia. Electronic address: t.nolan@unimelb.edu.au.""}, {'ForeName': 'Alfonso', 'Initials': 'A', 'LastName': 'Carmona Martínez', 'Affiliation': 'Instituto Hispalense de Pediatría, Sevilla, Spain. Electronic address: alfonsocarmona@ihppediatria.com.'}, {'ForeName': 'Federico', 'Initials': 'F', 'LastName': 'Martinón-Torres', 'Affiliation': 'Translational Pediatrics and Infectious Diseases, Pediatrics Department, Hospital Clínico Universitario de Santiago de Compostela and Genetics, Vaccines and Pediatrics Research Group, University of Santiago de Compostela, Instituto de Investigación Sanitaria de Santiago de Compostela, Santiago de Compostela, Spain. Electronic address: federico.martinon.torres@sergas.es.'}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'García-Sicilia', 'Affiliation': 'Hospital Universitario Madrid Sanchinarro, Madrid, Spain. Electronic address: jgarcia-sicilia@telefonica.net.'}, {'ForeName': 'Miia', 'Initials': 'M', 'LastName': 'Virta', 'Affiliation': 'Tampere Vaccine Research Center, Tampere University, Tampere, Finland. Electronic address: miia.virta@staff.uta.fi.'}, {'ForeName': 'Otto G', 'Initials': 'OG', 'LastName': 'Vanderkooi', 'Affiliation': ""Alberta Children's Hospital, University of Calgary, Alberta, Calgary, Canada. Electronic address: ovanderk@ucalgary.ca.""}, {'ForeName': 'Gian Vincenzo', 'Initials': 'GV', 'LastName': 'Zuccotti', 'Affiliation': 'Ospedale dei Bambini Vittore Buzzi, and University of Milan, Milan, Italy. Electronic address: gianvincenzo.zuccotti@unimi.it.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Manzoni', 'Affiliation': 'Ospedale Ostetrico Ginecologico Sant\'Anna, Turin, Italy and Department of Maternal-Infant -Pediatric Health, Hospital ""Degli Infermi"", Biella, Italy.'}, {'ForeName': 'Lusine', 'Initials': 'L', 'LastName': 'Kostanyan', 'Affiliation': 'Modis, C/O GSK, Wavre, Belgium. Electronic address: lusine.x.kostanyan@gsk.com.'}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Meyer', 'Affiliation': 'GSK, Wavre, Belgium. Electronic address: nadia.x.meyer@gsk.com.'}, {'ForeName': 'Maria Angeles', 'Initials': 'MA', 'LastName': 'Ceregido', 'Affiliation': 'GSK, Wavre, Belgium. Electronic address: maria-angeles.x.ceregido@gsk.com.'}, {'ForeName': 'Brigitte', 'Initials': 'B', 'LastName': 'Cheuvart', 'Affiliation': 'GSK, Wavre, Belgium. Electronic address: brigitte.cheuvart@gsk.com.'}, {'ForeName': 'Sherine O', 'Initials': 'SO', 'LastName': 'Kuriyakose', 'Affiliation': 'GSK, Bangalore, India. Electronic address: sherine.o.kuriyakose@gsk.com.'}, {'ForeName': 'Zbynek', 'Initials': 'Z', 'LastName': 'Stranak', 'Affiliation': 'Institute for the Care of Mother and Child, Prague, Czech Republic. Electronic address: z.stranak@seznam.cz.'}, {'ForeName': 'Jose M', 'Initials': 'JM', 'LastName': 'Merino Arribas', 'Affiliation': 'Nuevo Hospital Universitario de Burgos, Burgos, Spain.'}, {'ForeName': 'María José', 'Initials': 'MJ', 'LastName': 'Cilleruelo Ortega', 'Affiliation': 'Hospital Universitario Puerta de Hierro, Majadahonda, Majadahonda, Spain. Electronic address: mjose.cilleruelo@salud.madrid.org.'}, {'ForeName': 'Mariano', 'Initials': 'M', 'LastName': 'Miranda-Valdivieso', 'Affiliation': 'Hospital de Antequera, Antequera, Málaga, Spain. Electronic address: mariano.miranda@andaluciajunta.es.'}, {'ForeName': 'Begoña', 'Initials': 'B', 'LastName': 'Arias Novas', 'Affiliation': 'Hospital La Zarzuela, Aravaca, Spain. Electronic address: barias@sanitas.es.'}, {'ForeName': 'Jose Tomas', 'Initials': 'JT', 'LastName': 'Ramos Amador', 'Affiliation': 'Hospital Clínico San Carlos, Madrid, Spain. Electronic address: josetomas.ramos@salud.madrid.org.'}, {'ForeName': 'Felix', 'Initials': 'F', 'LastName': 'Omeñaca', 'Affiliation': 'Neonatologia, Hospital La Paz, Madrid, Spain.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Baca', 'Affiliation': 'Hospital Quiron Malaga, Andalucia, Malaga, Spain. Electronic address: pediatra@manuelbaca.com.'}, {'ForeName': 'Paola Giovanna', 'Initials': 'PG', 'LastName': 'Marchisio', 'Affiliation': 'Unità Pediatrica di Cure Altamente Intensive, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico, Lombardia, Milano, Italy. Electronic address: paola.marchisio@unimi.it.'}, {'ForeName': 'Narcisa', 'Initials': 'N', 'LastName': 'Mesaros', 'Affiliation': 'GSK, Wavre, Belgium. Electronic address: narcisa.x.mesaros@gsk.com.'}]",Vaccine,['10.1016/j.vaccine.2019.10.104'] 3099,31068396,Patient-Refined Messaging for a Mailed Colorectal Cancer Screening Program: Findings from the PROMPT Study.,"BACKGROUND Improving uptake of colorectal cancer screening has the potential of saving thousands of lives. We compared the effectiveness of automated and live prompts and reminders as part of a mailed fecal immunochemical test (FIT) outreach program. DESIGN AND METHODS Participants were 1767 adults aged 50 to 75 eyars who were not up-to-date with colorectal cancer screening recommendations at a participating community health center clinic. In addition to a mailed FIT kit, participants were randomized to receive (1) a text message prompt and 2 automated phone call reminders (automated condition); (2) up to 3 live call reminders (live condition); or (3) a text message prompt, 2 automated call reminders, and up to 3 live reminders (combined automated plus live condition). We assessed FIT completion rates in each group 6 months following randomization. KEY RESULTS Nearly one-third of participants completed an FIT within 6 months. Compared with adults allocated to the automated condition, FIT completion rates were higher in adults allocated to the live condition (32.3% vs 26.0%; adjusted difference, 6.3 percentage points; 95% CI, 1.1-11.4) and in adults allocated to the combined automated plus live condition (35.7% vs 26.0%; adjusted difference, 9.7 percentage points; 95% CI, 4.4-14.9). The number of kits needed to mail to achieve a completed FIT ranged from 2.8 in the combined automated plus live condition to 3.8 in the automated condition. CONCLUSIONS Among unscreened individuals in this population, live phone call reminders either alone or in combination with automated prompts and reminders outperformed automated approaches alone.",2019,"Among unscreened individuals in this population, live phone call reminders either alone or in combination with automated prompts and reminders outperformed automated approaches alone.",['Participants were 1767 adults aged 50 to 75 eyars who were not up-to-date with colorectal cancer screening recommendations at a participating community health center clinic'],"['text message prompt and 2 automated phone call reminders (automated condition); (2) up to 3 live call reminders (live condition); or (3) a text message prompt, 2 automated call reminders, and up to 3 live reminders (combined automated plus live condition']","['FIT completion rates', 'number of kits needed to mail to achieve a completed FIT']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0011008', 'cui_str': 'Dates'}, {'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C0220908', 'cui_str': 'Screening'}, {'cui': 'C0009469', 'cui_str': 'Satellite Centers'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}]","[{'cui': 'C3178910', 'cui_str': 'Text Messages'}, {'cui': 'C0205554', 'cui_str': 'Automated (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0337645', 'cui_str': 'Living Conditions'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1690540', 'cui_str': 'Kit'}, {'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C0024492', 'cui_str': 'Mail'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]",1767.0,0.134006,"Among unscreened individuals in this population, live phone call reminders either alone or in combination with automated prompts and reminders outperformed automated approaches alone.","[{'ForeName': 'Gloria D', 'Initials': 'GD', 'LastName': 'Coronado', 'Affiliation': 'From Center for Health Research, Kaiser Permanente Northwest, Portland, OR (GDC, JHT, AFP, DBN, MCL); AltaMed Health Services, Los Angeles, CA (MC, BY, AE, AC). Gloria.D.Coronado@kpchr.org.'}, {'ForeName': 'Jamie H', 'Initials': 'JH', 'LastName': 'Thompson', 'Affiliation': 'From Center for Health Research, Kaiser Permanente Northwest, Portland, OR (GDC, JHT, AFP, DBN, MCL); AltaMed Health Services, Los Angeles, CA (MC, BY, AE, AC).'}, {'ForeName': 'Amanda F', 'Initials': 'AF', 'LastName': 'Petrik', 'Affiliation': 'From Center for Health Research, Kaiser Permanente Northwest, Portland, OR (GDC, JHT, AFP, DBN, MCL); AltaMed Health Services, Los Angeles, CA (MC, BY, AE, AC).'}, {'ForeName': 'Denis B', 'Initials': 'DB', 'LastName': 'Nyongesa', 'Affiliation': 'From Center for Health Research, Kaiser Permanente Northwest, Portland, OR (GDC, JHT, AFP, DBN, MCL); AltaMed Health Services, Los Angeles, CA (MC, BY, AE, AC).'}, {'ForeName': 'Michael C', 'Initials': 'MC', 'LastName': 'Leo', 'Affiliation': 'From Center for Health Research, Kaiser Permanente Northwest, Portland, OR (GDC, JHT, AFP, DBN, MCL); AltaMed Health Services, Los Angeles, CA (MC, BY, AE, AC).'}, {'ForeName': 'Melissa', 'Initials': 'M', 'LastName': 'Castillo', 'Affiliation': 'From Center for Health Research, Kaiser Permanente Northwest, Portland, OR (GDC, JHT, AFP, DBN, MCL); AltaMed Health Services, Los Angeles, CA (MC, BY, AE, AC).'}, {'ForeName': 'Brittany', 'Initials': 'B', 'LastName': 'Younger', 'Affiliation': 'From Center for Health Research, Kaiser Permanente Northwest, Portland, OR (GDC, JHT, AFP, DBN, MCL); AltaMed Health Services, Los Angeles, CA (MC, BY, AE, AC).'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Escaron', 'Affiliation': 'From Center for Health Research, Kaiser Permanente Northwest, Portland, OR (GDC, JHT, AFP, DBN, MCL); AltaMed Health Services, Los Angeles, CA (MC, BY, AE, AC).'}, {'ForeName': 'Alex', 'Initials': 'A', 'LastName': 'Chen', 'Affiliation': 'From Center for Health Research, Kaiser Permanente Northwest, Portland, OR (GDC, JHT, AFP, DBN, MCL); AltaMed Health Services, Los Angeles, CA (MC, BY, AE, AC).'}]",Journal of the American Board of Family Medicine : JABFM,['10.3122/jabfm.2019.03.180275'] 3100,31924322,Comparison of the Effect of Age (< 75 Versus ≥ 75) on the Efficacy and Safety of Dual Therapy (Dabigatran + Clopidogrel or Ticagrelor) Versus Triple Therapy (Warfarin + Aspirin + Clopidogrel or Ticagrelor) in Patients With Atrial Fibrillation After Percutaneous Coronary Intervention (from the RE-DUAL PCI Trial).,"The RE-DUAL PCI trial reported that dabigatran dual therapy (110/150 mg twice daily, plus clopidogrel or ticagrelor) reduced bleeding events versus warfarin triple therapy (warfarin plus aspirin and clopidogrel or ticagrelor) in patients with atrial fibrillation who underwent percutaneous coronary intervention, with noninferiority in composite thromboembolic events. In this prespecified analysis, risks of first major or clinically relevant nonmajor bleeding event and composite end point of death, thromboembolic events, or unplanned revascularization were compared between dabigatran dual therapy and warfarin triple therapy in older (≥ 75 years) and younger (< 75 years) patients, using Cox proportional hazard regression. Of 2,725 patients randomized to treatment, 1,026 (37.7%) were categorized into older and 1,699 (62.3%) into younger age groups. Dabigatran 110 mg dual therapy lowered bleeding risk versus warfarin triple therapy in older (hazard ratio [HR] 0.67; 95% confidence interval [CI] 0.51 to 0.89) and younger patients (HR 0.40; 95% CI 0.30 to 0.54); interaction p value: 0.0125. Dabigatran 150 mg dual therapy lowered bleeding risk versus warfarin triple therapy in younger patients (HR 0.57; 95% CI 0.44 to 0.74), whereas no benefit could be observed in older patients (HR 1.21; 95% CI 0.83 to 1.77); interaction p value: 0.0013. For the thromboembolic end point, there was a trend for a higher risk with dabigatran 110 mg dual therapy in older patients, compared with warfarin triple therapy, whereas the risk was similar in younger patients. For dabigatran 150 mg dual therapy, the thromboembolic risk versus warfarin triple therapy was similar in older and younger patients. In conclusion, the benefits of dabigatran dual therapy differed in the 2 age groups, which may help dose selection when using dabigatran dual therapy.",2020,"For dabigatran 150 mg dual therapy, the thromboembolic risk versus warfarin triple therapy was similar in older and younger patients.","['older patients', 'older and younger patients', '2,725 patients randomized to treatment, 1,026 (37.7%) were categorized into older and 1,699 (62.3%) into younger age groups', 'patients with atrial fibrillation who underwent percutaneous coronary intervention, with noninferiority in composite thromboembolic events', 'Patients With Atrial Fibrillation']","['Percutaneous Coronary Intervention', 'Triple Therapy (Warfarin\u202f+\u202fAspirin\u202f+\u202fClopidogrel or Ticagrelor', 'clopidogrel or ticagrelor', 'Dual Therapy (Dabigatran\u202f+\u202fClopidogrel or Ticagrelor', 'Dabigatran', 'warfarin triple therapy (warfarin plus aspirin and clopidogrel or ticagrelor', 'warfarin triple therapy']","['thromboembolic risk', 'Efficacy and Safety', 'risks of first major or clinically relevant nonmajor bleeding event and composite end point of death, thromboembolic events, or unplanned revascularization', 'bleeding risk', 'bleeding events']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0027362', 'cui_str': 'Age Groups'}, {'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0040038', 'cui_str': 'Thromboembolism'}]","[{'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}, {'cui': 'C0205174', 'cui_str': 'Triple (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0043031', 'cui_str': 'Warfarin'}, {'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}, {'cui': 'C0070166', 'cui_str': 'clopidogrel'}, {'cui': 'C1999375', 'cui_str': 'Ticagrelor'}, {'cui': 'C2348066', 'cui_str': 'dabigatran'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0040038', 'cui_str': 'Thromboembolism'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}]",2725.0,0.0428795,"For dabigatran 150 mg dual therapy, the thromboembolic risk versus warfarin triple therapy was similar in older and younger patients.","[{'ForeName': 'Jurrien M', 'Initials': 'JM', 'LastName': 'Ten Berg', 'Affiliation': 'St Antonius Ziekenhuis, Nieuwegein, the Netherlands. Electronic address: jurtenberg@gmail.com.'}, {'ForeName': 'Philippe Gabriel', 'Initials': 'PG', 'LastName': 'Steg', 'Affiliation': 'French Alliance for Cardiovascular Trials (FACT), Hôpital Bichat, Paris, France; Université de Paris, Paris, France; INSERM U-1148, Paris, France; Hôpital Bichat, Assistance Publique-Hôpitaux de Paris, Paris, France.'}, {'ForeName': 'Deepak L', 'Initials': 'DL', 'LastName': 'Bhatt', 'Affiliation': ""Brigham and Women's Hospital Heart and Vascular Center and Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Stefan H', 'Initials': 'SH', 'LastName': 'Hohnloser', 'Affiliation': 'Johann Wolfgang Goethe University, Frankfurt am Main, Germany.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'de Veer', 'Affiliation': 'St Antonius Ziekenhuis, Nieuwegein, the Netherlands.'}, {'ForeName': 'Matias', 'Initials': 'M', 'LastName': 'Nordaby', 'Affiliation': 'Boehringer Ingelheim International GmbH, Ingelheim, Germany.'}, {'ForeName': 'Corinna', 'Initials': 'C', 'LastName': 'Miede', 'Affiliation': 'HMS Analytical Software GmbH, Weimar (Lahn), Germany.'}, {'ForeName': 'Takeshi', 'Initials': 'T', 'LastName': 'Kimura', 'Affiliation': 'Kyoto University, Kyoto, Japan.'}, {'ForeName': 'Gregory Y H', 'Initials': 'GYH', 'LastName': 'Lip', 'Affiliation': 'Liverpool Centre for Cardiovascular Science, University of Liverpool and Liverpool Heart and Chest Hospital, Liverpool, United Kingdom; Aalborg Thrombosis Research Unit, Department of Clinical Medicine, Aalborg University, Aalborg, Denmark.'}, {'ForeName': 'Jonas', 'Initials': 'J', 'LastName': 'Oldgren', 'Affiliation': 'Uppsala Clinical Research Center and Department of Medical Sciences, Uppsala University, Uppsala, Sweden.'}, {'ForeName': 'Christopher P', 'Initials': 'CP', 'LastName': 'Cannon', 'Affiliation': ""Brigham and Women's Hospital Heart and Vascular Center and Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The American journal of cardiology,['10.1016/j.amjcard.2019.11.029'] 3101,31838561,"Oral vinorelbine versus intravenous vinorelbine, in combination with epirubicin as first-line chemotherapy in Chinese patients with metastatic breast cancer.","Oral VRL offers easier administration, better quality of life, and cost saving. This study aimed to evaluate the treatment efficacy in terms of tumor response of the two formulations of vinorelbine (VRL, oral and IV) in combination with epirubicin (EPI); and the effect of EPI co-administration on VRL pharmacokinetics (PK) in Chinese patients with metastatic breast cancer (MBC) using a phase 2, open label, randomized trial. Patients were aged 18-70 years, had histologically confirmed MBC, Karnofsky Performance Status ≥ 70%, and life expectancy ≥ 12 weeks. The treatment consisted of 6 cycles of 3 weeks each. VRL dose was: (Oral-VRL) 60 mg/m 2 for cycle 1, 80 mg/m 2 for cycles 2-6, and (IV-VRL) 25 mg/m 2 for cycle 1 and 30 mg/m 2 for cycles 2-6. EPI dose of 75 mg/m 2 was given on day 1 in both arms for all cycles. 133 patients were enrolled: 66 in Oral-VRL and 67 in IV-VRL arms. The median age for Oral-VRL and IV-VRL arms was 48.4 and 50.0 years, respectively. Objective response rates were 50.0% (95% CI 37.4-62.6%) for Oral-VRL and 53.7% (95% CI 41.1-66.0%) for IV-VRL. Both treatment arms met the efficacy objective target of at least 31 responses, demonstrating efficacy as first-line treatment for MBC. Similar blood PK profiles, exposures, and VRL clearance were observed between VRL + EPI vs VRL-only modalities for both arms. Oral VRL is comparable to IV VRL and an effective first-line treatment for Chinese patients with MBC. The activity of VRL + EPI combination is unaltered when VRL is given orally at recommended doses.",2020,Objective response rates were 50.0% (95% CI 37.4-62.6%) for Oral-VRL and 53.7% (95% CI 41.1-66.0%) for IV-VRL.,"['Chinese patients with MBC', 'Chinese patients with metastatic breast cancer', 'Chinese patients with metastatic breast cancer (MBC', '133 patients were enrolled: 66 in Oral-VRL and 67 in IV-VRL arms', 'Patients were aged 18-70\xa0years, had histologically confirmed MBC, Karnofsky Performance Status ≥\u200970%, and life expectancy\u2009≥\u200912\xa0weeks']","['Oral vinorelbine', 'Oral VRL', 'VRL dose was: (Oral-VRL', 'epirubicin', 'vinorelbine (VRL, oral and IV) in combination with epirubicin (EPI', 'EPI co-administration', 'vinorelbine']","['Similar blood PK profiles, exposures, and VRL clearance', 'quality of life, and cost saving', 'VRL pharmacokinetics (PK', 'Objective response rates']","[{'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0278488', 'cui_str': 'Breast cancer metastatic'}, {'cui': 'C4517563', 'cui_str': '133'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0206065', 'cui_str': 'Karnofsky Scale'}, {'cui': 'C0023671', 'cui_str': 'Life Expectancy'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0078257', 'cui_str': 'vinorelbine'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0014582', 'cui_str': 'Epirubicin'}, {'cui': 'C0267963', 'cui_str': 'Pancreatic Insufficiency'}, {'cui': 'C1533734', 'cui_str': 'Administration'}]","[{'cui': 'C0005768'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0449297', 'cui_str': 'Clearance (attribute)'}, {'cui': 'C0034380'}, {'cui': 'C0085550', 'cui_str': 'Saving, Cost'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}]",133.0,0.055984,Objective response rates were 50.0% (95% CI 37.4-62.6%) for Oral-VRL and 53.7% (95% CI 41.1-66.0%) for IV-VRL.,"[{'ForeName': 'Liang', 'Initials': 'L', 'LastName': 'Huang', 'Affiliation': ""Department of Breast Surgery, Fudan University Shanghai Cancer Center/Cancer Institute, 399 Ling-Ling Road, Shanghai, 200032, People's Republic of China.""}, {'ForeName': 'Xiaojia', 'Initials': 'X', 'LastName': 'Wang', 'Affiliation': ""Zhejiang Cancer Hospital, No.1, East Banshan Road, Gongshu District, Hangzhou, 310022, People's Republic of China.""}, {'ForeName': 'Liheng', 'Initials': 'L', 'LastName': 'Zhou', 'Affiliation': ""Shanghai Jiatong University School of Medicine Renji Hospital, 145 Shandong Middle Rd, Huangpu Qu, Shanghai, 200333, People's Republic of China.""}, {'ForeName': 'Lijun', 'Initials': 'L', 'LastName': 'Di', 'Affiliation': ""Beijing Cancer Hospital, 52 Fucheng Rd, Wu Ke Song, Beijing, 100091, People's Republic of China.""}, {'ForeName': 'Hongyu', 'Initials': 'H', 'LastName': 'Zheng', 'Affiliation': ""Fujian Provincial Cancer Hospital, 91 Fengban Maluding, Fuma Lu, Jin'an District, Fuzhou, 350014, People's Republic of China.""}, {'ForeName': 'Zefei', 'Initials': 'Z', 'LastName': 'Jiang', 'Affiliation': ""307 Hospital of PLA, 8 East St, Fengtai Qu, Beijing, 100160, People's Republic of China.""}, {'ForeName': 'Yongsheng', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': ""Shangdong Cancer Hospital, Jinan, 250117, People's Republic of China.""}, {'ForeName': 'Xiangqun', 'Initials': 'X', 'LastName': 'Song', 'Affiliation': ""Guangxi Medical University Affiliated Cancer Hospital, Fukang Rd, Qingxiu Qu, Nanning, 530015, People's Republic of China.""}, {'ForeName': 'Jifeng', 'Initials': 'J', 'LastName': 'Feng', 'Affiliation': ""Jiangsu Cancer Hospital, Nanjing, 210009, Jiangsu, People's Republic of China.""}, {'ForeName': 'Shiying', 'Initials': 'S', 'LastName': 'Yu', 'Affiliation': ""Tongji Hospital, No.1095 Jie Fang Avenue, Hankou, Wuhan, 430030, People's Republic of China.""}, {'ForeName': 'Yunpeng', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': ""The First Hospital of China Medical University, Taiyuan Street Business Area, Heping, Shenyang, 110003, People's Republic of China.""}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Zheng', 'Affiliation': ""West China Hospital of Sichuan University, No.37 Guoxue Alley, Wuhou District, Chengdu, Sichuan, People's Republic of China.""}, {'ForeName': 'Kunwei', 'Initials': 'K', 'LastName': 'Shen', 'Affiliation': ""Ruijin Hospital Shanghai Jiao Tong University School of Medicine, No. 197, Rui Jin Er Road, Shanghai, 200025, People's Republic of China.""}, {'ForeName': 'Zhongsheng', 'Initials': 'Z', 'LastName': 'Tong', 'Affiliation': ""Tianjin Medical University Cancer Institute and Hospital, Binshui Rd, Hexi Qu, Tianjin, 300011, People's Republic of China.""}, {'ForeName': 'Zhimin', 'Initials': 'Z', 'LastName': 'Shao', 'Affiliation': ""Department of Breast Surgery, Fudan University Shanghai Cancer Center/Cancer Institute, 399 Ling-Ling Road, Shanghai, 200032, People's Republic of China. zhimingshao@outlook.com.""}]",Cancer chemotherapy and pharmacology,['10.1007/s00280-019-04000-3'] 3102,32057624,An Innovative Pain Control Method Using Peripheral Nerve Block and Patient-Controlled Analgesia With Ketorolac After Bone Surgery in the Ankle Area: A Prospective Study.,"Although postoperative pain is inevitable after bone surgery, there is no general consensus regarding its ideal management. We hypothesized that the combination of ultrasound-guided peripheral nerve block (PNB) and patient-controlled analgesia (PCA) with ketorolac would be useful for pain control and reducing opioid usage. This prospective study aimed to evaluate the effectiveness of this method. This study included 95 patients aged >18 years who underwent bone surgery in the ankle area from June to December 2018. All operations were performed under anesthetic PNB, and additional PNB was given for pain control ∼11 hours after preoperative PNB. An additional PCA with ketorolac, started before rebound pain was experienced, was used for pain control in group A (49 patients) but not group B (46 patients). We used intramuscular injection with pethidine or ketorolac as rescue analgesics if pain persisted. A visual analogue scale (VAS) for pain was used to quantify pain at 6, 12, 18, 24, 36, 48, and 72 hours postoperatively. Patient satisfaction was assessed, along with side effects in both groups. VAS pain scores differed significantly between the groups at 24 hours after the operation (p = .013). All patients in group A were satisfied with the pain control method; however, 5 patients in group B were dissatisfied (p = .001), 3 owing to severe postoperative pain and 2 owing to postoperative nausea and vomiting. An average of 0.75 and 11.40 mg pethidine per patient was used in groups A and B, respectively, for 3 days. We concluded that the combined use of ultrasound-guided PNB and PCA with ketorolac can be an effective postoperative method of pain control that can reduce opioid usage.",2020,VAS pain scores differed significantly between the groups at 24 hours after the operation (p = .013).,"['95 patients aged >18 years who underwent bone surgery in the ankle area from June to December 2018', 'After Bone Surgery in the Ankle Area']","['ultrasound-guided peripheral nerve block (PNB) and patient-controlled analgesia (PCA) with ketorolac', 'pethidine or ketorolac', 'pethidine', 'Ketorolac', 'ketorolac']","['A visual analogue scale (VAS) for pain', 'severe postoperative pain', 'VAS pain scores', 'Patient satisfaction', 'postoperative nausea and vomiting']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0003086', 'cui_str': 'Regio tarsalis'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}]","[{'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0198807', 'cui_str': 'Peripheral block anesthesia (procedure)'}, {'cui': 'C0078944', 'cui_str': 'Patient-Controlled Analgesia'}, {'cui': 'C0073631', 'cui_str': 'Ketorolac'}, {'cui': 'C0025376', 'cui_str': 'pethidine'}]","[{'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C0520909', 'cui_str': 'PONV'}]",95.0,0.0457574,VAS pain scores differed significantly between the groups at 24 hours after the operation (p = .013).,"[{'ForeName': 'Jeong-Kil', 'Initials': 'JK', 'LastName': 'Lee', 'Affiliation': 'Fellow, Department of Orthopaedic Surgery, Chungnam National University Hospital, Daejeon, Korea.'}, {'ForeName': 'Chan', 'Initials': 'C', 'LastName': 'Kang', 'Affiliation': 'Associate Professor, Department of Orthopaedic Surgery, Chungnam National University Hospital, Daejeon, Korea. Electronic address: faschan@daum.net.'}, {'ForeName': 'Deuk-Soo', 'Initials': 'DS', 'LastName': 'Hwang', 'Affiliation': 'Professor, Department of Orthopaedic Surgery, Chungnam National University Hospital, Daejeon, Korea.'}, {'ForeName': 'Gi-Soo', 'Initials': 'GS', 'LastName': 'Lee', 'Affiliation': 'Associate Professor, Department of Orthopaedic Surgery, Chungnam National University Hospital, Daejeon, Korea.'}, {'ForeName': 'Jung-Mo', 'Initials': 'JM', 'LastName': 'Hwang', 'Affiliation': 'Associate Professor, Department of Orthopaedic Surgery, Chungnam National University Hospital, Daejeon, Korea.'}, {'ForeName': 'Eugene Jae-Jin', 'Initials': 'EJ', 'LastName': 'Park', 'Affiliation': 'Associate Professor, Department of Orthopaedic Surgery, Chungnam National University Hospital, Daejeon, Korea.'}, {'ForeName': 'In-Ho', 'Initials': 'IH', 'LastName': 'Ga', 'Affiliation': 'Resident, Department of Orthopaedic Surgery, Chungnam National University Hospital, Daejeon, Korea.'}]",The Journal of foot and ankle surgery : official publication of the American College of Foot and Ankle Surgeons,['10.1053/j.jfas.2019.12.001'] 3103,31351659,"The Oxytocin Antagonist Cligosiban Prolongs Intravaginal Ejaculatory Latency and Improves Patient-Reported Outcomes in Men with Lifelong Premature Ejaculation: Results of a Randomized, Double-Blind, Placebo-Controlled Proof-of-Concept Trial (PEPIX).","INTRODUCTION Cligosiban is an orally administered oxytocin receptor antagonist being developed to treat premature ejaculation (PE). AIM To determine the safety and efficacy of cligosiban capsules (dose range 400-800 mg) to improve intravaginal ejaculation latency time (IELT) and patient-reported outcomes in men with severe lifelong PE. METHODS Patients recorded details of at least 4 sexual intercourse events during a 4-week run-in period, after which they underwent baseline assessments. Patients were eligible for the study if they rated their control of ejaculation as poor/very poor and their stopwatch-assessed IELT was ≤1 minute in ≥75% of intercourse attempts. Eligible patients were randomized to an 8-week treatment period with double-blind cligosiban or placebo (to be taken 1 to 6 hours prior to sexual activity). The starting dose was 400 mg (not more than 1 dose per day) which could be increased to 800 mg after 2 and/or 4 weeks of treatment. Assessments were conducted at 2, 4, and 8 weeks. MAIN OUTCOME MEASURE Efficacy measures were comprised of IELT, self-rating of ejaculation control and ejaculation-related distress (recorded in an electronic diary after each intercourse attempt), premature ejaculation profile, and the Clinical Global Impression of Change. RESULTS The mean ratio of fold change from baseline in IELT to the last 4 weeks of treatment (cligosiban/placebo) was 1.9 compared to a baseline of 1.0 (P = .0079). The mean increase in IELT from baseline to the last 4 weeks of treatment was 61.0 seconds for cligosiban, which was significantly different from (and 3.6-fold greater than) the mean increase of 16.4 seconds for placebo (P = .0086). Statistically significant improvements in ejaculation control and ejaculation-related personal distress scores were also observed for cligosiban compared to little or no change with placebo. Cligosiban was generally well tolerated, with no serious or severe adverse events or other safety parameters. CLINICAL IMPLICATIONS This proof-of-concept study demonstrated the potential for cligosiban, an oxytocin antagonist, to successfully treat symptoms of severe lifelong PE. STRENGTHS AND LIMITATIONS This was a Phase II, randomized, double-blind, placebo-controlled study that was adequately powered to detect a clinically meaningful difference in change in IELT between cligosiban and placebo. Larger studies will be needed to confirm these findings, determine the optimal dose of cligosiban and assess efficacy in men with acquired PE. CONCLUSIONS Cligosiban was well tolerated, and resulted in significant benefits in both objective and subjective measures of ejaculatory control in men with lifelong PE and therefore offers significant potential as an on-demand, orally administered agent for the treatment of PE. McMahon C, Althof S, Rosen R, et al. The Oxytocin Antagonist Cligosiban Prolongs Intravaginal Ejaculatory Latency and Improves Patient-Reported Outcomes in Men with Lifelong Premature Ejaculation: Results of a Randomized, Double-Blind, Placebo-Controlled Proof-of-Concept Trial (PEPIX). J Sex Med 2019; 16:1178-1187.",2019,Statistically significant improvements in ejaculation control and ejaculation-related personal distress scores were also observed for cligosiban compared to little or no change with placebo.,"['men with acquired PE', 'Eligible patients', 'men with lifelong PE', 'Men with Lifelong Premature Ejaculation', 'men with severe lifelong PE.\nMETHODS\n\n\nPatients recorded details of at least 4 sexual intercourse events during a 4-week run-in period, after which they underwent baseline assessments']","['double-blind cligosiban or placebo', 'cligosiban capsules', 'Oxytocin Antagonist Cligosiban', 'placebo', 'Placebo']","['mean ratio of fold change', 'mean increase in IELT', 'ejaculation control and ejaculation-related personal distress scores', 'IELT, self-rating of ejaculation control and ejaculation-related distress (recorded in an electronic diary after each intercourse attempt), premature ejaculation profile, and the Clinical Global Impression of Change', 'intravaginal ejaculation latency time (IELT', 'safety and efficacy']","[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0439661', 'cui_str': 'Acquired (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4274169', 'cui_str': 'Entire period of life between birth and death'}, {'cui': 'C0033038', 'cui_str': 'Ejaculatio Praecox'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0009253', 'cui_str': 'Sexual Intercourse'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0600140', 'cui_str': 'Does run (finding)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}]","[{'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4319574', 'cui_str': 'Capsule'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0243076', 'cui_str': 'antagonists'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0185026', 'cui_str': 'Plication - action (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0013746', 'cui_str': 'Ejaculation'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C4281784', 'cui_str': 'Electronics'}, {'cui': 'C0376660', 'cui_str': 'Diary'}, {'cui': 'C0009253', 'cui_str': 'Sexual Intercourse'}, {'cui': 'C0033038', 'cui_str': 'Ejaculatio Praecox'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0442122', 'cui_str': 'Intravaginal (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.486538,Statistically significant improvements in ejaculation control and ejaculation-related personal distress scores were also observed for cligosiban compared to little or no change with placebo.,"[{'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'McMahon', 'Affiliation': 'Australian Centre for Sexual Health, St. Leonards, New South Wales, Australia. Electronic address: chrisgmcmahon@gmail.com.'}, {'ForeName': 'Stanley', 'Initials': 'S', 'LastName': 'Althof', 'Affiliation': 'Center for Marital and Sexual Health of South Florida, West Palm Beach, FL, USA.'}, {'ForeName': 'Raymond', 'Initials': 'R', 'LastName': 'Rosen', 'Affiliation': 'New England Research Institutes, Watertown, MA, USA.'}, {'ForeName': 'Francois', 'Initials': 'F', 'LastName': 'Giuliano', 'Affiliation': 'AP-HP, Neuro-Uro-Andrology, Physical Medicine and Rehabilitation Department, Raymond Poincaré Hospital, Garches, France; UMR1179 Inserm-Versailles Saint Quentin en Yvelines University, Versailles, France.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Miner', 'Affiliation': ""Departments of Family Medicine and Urology, Men's Health Center, Miriam Hospital, Brown University, Providence, RI, USA.""}, {'ForeName': 'Ian H', 'Initials': 'IH', 'LastName': 'Osterloh', 'Affiliation': 'Ixchelsis Ltd, Sandwich, UK.'}, {'ForeName': 'Gary J', 'Initials': 'GJ', 'LastName': 'Muirhead', 'Affiliation': 'Ixchelsis Ltd, Sandwich, UK.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Harty', 'Affiliation': 'New England Research Institutes, Watertown, MA, USA.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The journal of sexual medicine,['10.1016/j.jsxm.2019.05.016'] 3104,31351660,"The Oxytocin Antagonist Cligosiban Fails to Prolong Intravaginal Ejaculatory Latency in Men with Lifelong Premature Ejaculation: Results of a Randomized, Double-Blind, Placebo-Controlled Phase IIb trial (PEDRIX).","INTRODUCTION Cligosiban is an orally administered, centrally penetrant oxytocin receptor antagonist being developed to treat premature ejaculation (PE). AIM To determine the efficacy of 3 dose levels of cligosiban caplets to prolong intravaginal ejaculation latency time (IELT) and improve patient-reported outcomes in men with lifelong PE. METHODS Patients recorded details of at least 4 sexual intercourse events during a 4-week run-in period, after which they underwent baseline assessments. Patients were eligible for the study if their stopwatch-assessed IELT was ≤1 minute in ≥75% of intercourse attempts and if they met other diagnostic criteria for lifelong PE. Eligible patients (target 220 evaluable) were randomized to double-blind cligosiban 400, 800, or 1200 mg or matching placebo caplets (to be taken 1 to 6 hours prior to sexual activity). Assessments were conducted at 2, 4, and 8 weeks. MAIN OUTCOME MEASURE Efficacy measures were comprised of IELT, self-rating of ejaculation control and ejaculation-related distress (recorded in an electronic diary after each intercourse attempt), premature ejaculation profile, Patient's Global Impression of Severity, and the Clinical Global Impression of Change. RESULTS There were no clinically or statistically significant differences between cligosiban (at any dose level) and placebo for the primary endpoint (change in geometric IELT) or any of the secondary endpoints. Cligosiban was well tolerated with a side-effect profile similar to placebo. CLINICAL IMPLICATIONS This Phase IIb study failed to demonstrate the potential for cligosiban, an oxytocin antagonist, to successfully treat symptoms of severe lifelong PE at doses up to 1200 mg. STRENGTHS AND LIMITATIONS This was a Phase IIb, randomized, double-blind, placebo-controlled study that was adequately powered but failed to detect a clinically meaningful or statistical difference in change in IELT between cligosiban at 3 dose levels and placebo. This is in contrast to a similarly designed proof-of-concept study where cligosiban was flexibly dosed at doses up to 800 mg and did demonstrate clinically meaningful and statistically significant changes in efficacy parameters. The reasons for this disparity are not known. CONCLUSIONS Cligosiban was well tolerated but failed to demonstrate efficacy for the treatment of men with lifelong PE at doses up to 1200 mg. Althof S, Osterloh IH, Muirhead GJ, et al. The Oxytocin Antagonist Cligosiban Fails to Prolong Intravaginal Ejaculatory Latency in Men with Lifelong Premature Ejaculation: Results of a Randomized, Double-Blind, Placebo-Controlled Phase IIb trial (PEDRIX). J Sex Med 2019; 16:1188-1198.",2019,The Oxytocin Antagonist Cligosiban Fails to Prolong Intravaginal Ejaculatory Latency in Men with Lifelong Premature Ejaculation:,"['Patients were eligible for the study if their stopwatch-assessed IELT was ≤1 minute in ≥75% of intercourse attempts and if they met other diagnostic criteria for lifelong PE', 'men with lifelong PE.\nMETHODS\n\n\nPatients recorded details of at least 4 sexual intercourse events during a 4-week run-in period, after which they underwent baseline assessments', 'Eligible patients (target 220 evaluable', 'Men with Lifelong Premature Ejaculation']","['Oxytocin Antagonist Cligosiban', 'placebo', 'Cligosiban', 'double-blind cligosiban 400, 800, or 1200 mg or matching placebo caplets', 'Placebo', 'cligosiban caplets']","['intravaginal ejaculation latency time (IELT', 'efficacy parameters', 'geometric IELT', ""IELT, self-rating of ejaculation control and ejaculation-related distress (recorded in an electronic diary after each intercourse attempt), premature ejaculation profile, Patient's Global Impression of Severity, and the Clinical Global Impression of Change"", 'Intravaginal Ejaculatory Latency']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0348026', 'cui_str': 'Diagnostic'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}, {'cui': 'C4274169', 'cui_str': 'Entire period of life between birth and death'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C0009253', 'cui_str': 'Sexual Intercourse'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0600140', 'cui_str': 'Does run (finding)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C4517650', 'cui_str': '220 (qualifier value)'}, {'cui': 'C0033038', 'cui_str': 'Ejaculatio Praecox'}]","[{'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C0243076', 'cui_str': 'antagonists'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C3816746', 'cui_str': 'Four hundred'}, {'cui': 'C3844106', 'cui_str': 'Eight hundred'}, {'cui': 'C4517548', 'cui_str': 'One thousand two hundred'}, {'cui': 'C0336766', 'cui_str': 'Matches'}]","[{'cui': 'C0442122', 'cui_str': 'Intravaginal (qualifier value)'}, {'cui': 'C0013746', 'cui_str': 'Ejaculation'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C4281784', 'cui_str': 'Electronics'}, {'cui': 'C0376660', 'cui_str': 'Diary'}, {'cui': 'C0009253', 'cui_str': 'Sexual Intercourse'}, {'cui': 'C0033038', 'cui_str': 'Ejaculatio Praecox'}, {'cui': 'C4720882', 'cui_str': 'PGI-S-Patient global impression of severity'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]",,0.531489,The Oxytocin Antagonist Cligosiban Fails to Prolong Intravaginal Ejaculatory Latency in Men with Lifelong Premature Ejaculation:,"[{'ForeName': 'Stanley', 'Initials': 'S', 'LastName': 'Althof', 'Affiliation': 'Case Western Reserve University Medical School and Center for Marital and Sexual Health of South Florida, West Palm Beach, FL, USA. Electronic address: stanley.althof@case.edu.'}, {'ForeName': 'Ian H', 'Initials': 'IH', 'LastName': 'Osterloh', 'Affiliation': 'Ixchelsis Ltd, Sandwich, UK.'}, {'ForeName': 'Gary J', 'Initials': 'GJ', 'LastName': 'Muirhead', 'Affiliation': 'Ixchelsis Ltd, Sandwich, UK.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'George', 'Affiliation': 'Therapy Research Services Ltd, Headcorn, UK.'}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Girard', 'Affiliation': 'PPD France, Ivry-sur-Seine, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The journal of sexual medicine,['10.1016/j.jsxm.2019.05.015'] 3105,32055864,The effects of the number of consecutive night shifts on sleep duration and quality.,"Objectives The organization of night shift work affects sleep duration and quality. The aim of this study was to investigate the effects of the number of consecutive night shifts on sleep duration and quality among police officers with night shift work as part of their normal schedule. Methods This quasi-experimental, within-subject crossover study included 73 police officers. All participants performed three work schedules: two, four and seven consecutive night shifts followed by the same number of recovery days, ie, day work or days off (2+2, 4+4, and 7+7). Sleep assessed through sleep diaries and actigraphy after all night shifts and recovery days (totaling 26 days) was compared by use of repeated measures analysis. Results Participants experienced shorter sleep duration (with and without naps), more premature awakening, less difficulty falling asleep, and more non-refreshing sleep after night shifts compared with recovery days. Sleep duration and quality did not change with increasing number of consecutive night shifts. Sleep was shorter and of poorer quality after the last night shift in the 2+2 and 4+4 work schedule compared with the second and fourth night shift, respectively, in the 7+7 schedule. Conclusion Sleep duration was reduced after night shift work and did not increase with more consecutive night shifts, which leads to accumulated sleep debt. Sleep duration was shortest and sleep quality was poorest after the last night shift in a series of night shifts.",2020,"Sleep was shorter and of poorer quality after the last night shift in the 2+2 and 4+4 work schedule compared with the second and fourth night shift, respectively, in the 7+7 schedule.",['73 police officers'],[],"['shorter sleep duration', 'Conclusion Sleep duration', 'Sleep duration and quality', 'premature awakening, less difficulty falling asleep, and more non-refreshing sleep', 'sleep duration and quality', 'Sleep duration', 'Sleep assessed through sleep diaries and actigraphy', 'Sleep', 'sleep quality']","[{'cui': 'C0086825', 'cui_str': 'Policeman (occupation)'}]",[],"[{'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0205252', 'cui_str': 'Immature (qualifier value)'}, {'cui': 'C1720052', 'cui_str': 'Awakening'}, {'cui': 'C0393760', 'cui_str': 'Initial insomnia (disorder)'}, {'cui': 'C0376660', 'cui_str': 'Diary'}, {'cui': 'C1171301', 'cui_str': 'Actigraphy'}]",73.0,0.0138906,"Sleep was shorter and of poorer quality after the last night shift in the 2+2 and 4+4 work schedule compared with the second and fourth night shift, respectively, in the 7+7 schedule.","[{'ForeName': 'Anne Helene', 'Initials': 'AH', 'LastName': 'Garde', 'Affiliation': 'The National Research Centre for the Working Environment, Lersø Parkallé 105, 2100 Copenhagen, Denmark. ahg@nfa.dk.'}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Nabe-Nielsen', 'Affiliation': ''}, {'ForeName': 'Marie Aarrebo', 'Initials': 'MA', 'LastName': 'Jensen', 'Affiliation': ''}, {'ForeName': 'Jesper', 'Initials': 'J', 'LastName': 'Kristiansen', 'Affiliation': ''}, {'ForeName': 'Jeppe Karl', 'Initials': 'JK', 'LastName': 'Sørensen', 'Affiliation': ''}, {'ForeName': 'Åse Marie', 'Initials': 'ÅM', 'LastName': 'Hansen', 'Affiliation': ''}]","Scandinavian journal of work, environment & health",['10.5271/sjweh.3885'] 3106,31759092,Feeling needed: Effects of a randomized generativity intervention on well-being and inflammation in older women.,"Generativity, or concern for and contribution to the well-being of younger generations, plays an important role in successful aging. The purpose of this study was to develop a novel, writing-based intervention to increase feelings of generativity and test the effect of this intervention on well-being and inflammation in a sample of older women. Participants in this study (n = 73; mean age = 70.9 years, range 60-86 years) were randomly assigned to a 6-week generativity writing condition (writing about life experiences and sharing advice with others) or a control writing condition (neutral, descriptive writing). Self-reported measures of social well-being, mental health, and physical health, as well as objective measures of systemic and cellular levels of inflammation (plasma pro-inflammatory cytokines interleukin-6 and tumor necrosis factor-α; genome-wide RNA transcriptional profiling), were assessed pre- and post-intervention. The generativity intervention led to significant improvements across multiple domains, including increases in participation in social activities, decreases in psychological distress, more positive expectations regarding aging in the physical health domain, and decreases in pro-inflammatory gene expression. Thus, this study provides preliminary evidence for the ability of a novel, low-cost, low-effort intervention to favorably impact inflammation and well-being in older women.",2020,"The generativity intervention led to significant improvements across multiple domains, including increases in participation in social activities, decreases in psychological distress, more positive expectations regarding aging in the physical health domain, and decreases in pro-inflammatory gene expression.","['older women', 'Participants in this study (n=73; mean age = 70.9 years, range 60-86 years', 'Older Women']","['6-week generativity writing condition (writing about life experiences and sharing advice with others) or a control writing condition (neutral, descriptive writing', 'Generativity Intervention']","['participation in social activities', 'psychological distress, more positive expectations regarding aging in the physical health domain, and decreases in pro-inflammatory gene expression', 'social well-being, mental health, and physical health']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}]","[{'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0043266', 'cui_str': 'Writing'}, {'cui': 'C0023672', 'cui_str': 'Life Experiences'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0679138', 'cui_str': 'Expectations'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0547047', 'cui_str': 'Decrease (qualifier value)'}, {'cui': 'C0017262', 'cui_str': 'Gene Expression'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}]",,0.0546092,"The generativity intervention led to significant improvements across multiple domains, including increases in participation in social activities, decreases in psychological distress, more positive expectations regarding aging in the physical health domain, and decreases in pro-inflammatory gene expression.","[{'ForeName': 'Mona', 'Initials': 'M', 'LastName': 'Moieni', 'Affiliation': 'Department of Psychology, University of California, Los Angeles, CA 90095, USA.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Irwin', 'Affiliation': 'Department of Psychology, University of California, Los Angeles, CA 90095, USA; Semel Institute for Neuroscience and Human Behavior, Cousins Center for Psychoneuroimmunology, University of California, Los Angeles, CA 90095, USA.'}, {'ForeName': 'Teresa E', 'Initials': 'TE', 'LastName': 'Seeman', 'Affiliation': 'Department of Medicine, Division of Geriatrics, David Geffen School of Medicine, University of California, Los Angeles, CA 90095, USA.'}, {'ForeName': 'Theodore F', 'Initials': 'TF', 'LastName': 'Robles', 'Affiliation': 'Department of Psychology, University of California, Los Angeles, CA 90095, USA.'}, {'ForeName': 'Matthew D', 'Initials': 'MD', 'LastName': 'Lieberman', 'Affiliation': 'Department of Psychology, University of California, Los Angeles, CA 90095, USA.'}, {'ForeName': 'Elizabeth C', 'Initials': 'EC', 'LastName': 'Breen', 'Affiliation': 'Semel Institute for Neuroscience and Human Behavior, Cousins Center for Psychoneuroimmunology, University of California, Los Angeles, CA 90095, USA.'}, {'ForeName': 'Stephanie', 'Initials': 'S', 'LastName': 'Okimoto', 'Affiliation': 'UCLA Clinical and Translational Research Center, David Geffen School of Medicine, University of California, Los Angeles, CA 90095, USA.'}, {'ForeName': 'Clara', 'Initials': 'C', 'LastName': 'Lengacher', 'Affiliation': 'Department of Psychology, University of California, Los Angeles, CA 90095, USA.'}, {'ForeName': 'Jesusa M G', 'Initials': 'JMG', 'LastName': 'Arevalo', 'Affiliation': 'Department of Medicine, Division of Hematology-Oncology, and Department of Psychiatry and Biobehavioral Sciences, University of California, Los Angeles, CA 90095, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Olmstead', 'Affiliation': 'Semel Institute for Neuroscience and Human Behavior, Cousins Center for Psychoneuroimmunology, University of California, Los Angeles, CA 90095, USA.'}, {'ForeName': 'Steven W', 'Initials': 'SW', 'LastName': 'Cole', 'Affiliation': 'Semel Institute for Neuroscience and Human Behavior, Cousins Center for Psychoneuroimmunology, University of California, Los Angeles, CA 90095, USA; Department of Medicine, Division of Hematology-Oncology, and Department of Psychiatry and Biobehavioral Sciences, University of California, Los Angeles, CA 90095, USA.'}, {'ForeName': 'Naomi I', 'Initials': 'NI', 'LastName': 'Eisenberger', 'Affiliation': 'Department of Psychology, University of California, Los Angeles, CA 90095, USA. Electronic address: neisenbe@ucla.edu.'}]","Brain, behavior, and immunity",['10.1016/j.bbi.2019.11.014'] 3107,31813108,Influence of a Combined Gluten-Free and Casein-Free Diet on Behavior Disorders in Children and Adolescents Diagnosed with Autism Spectrum Disorder: A 12-Month Follow-Up Clinical Trial.,"The use of alternative interventions, such as gluten-free and casein-free (GFCF) diets, is frequent due to limited therapies for Autism Spectrum Disorder (ASD). Our aims were to determine the influence of a GFCF diet on behavior disorders in children and adolescents diagnosed with ASD and the potential association with urinary beta-casomorphin concentrations. Thirty-seven patients were recruited for this crossover trial. Each patient consumed a normal diet (including gluten and casein) for 6 months and a GFCF diet for another 6 months. The order of the intervention (beginning with normal diet or with GFCF diet) was assigned randomly. Patients were evaluated at three time-points (at the beginning of the study, after normal diet and after GFCF diet). Questionnaires regarding behavior and autism and dietary adherence were completed and urinary beta-casomorphin concentrations were determined at each time-point. No significant behavioral changes and no association with urinary beta-casomorphin concentrations were found after GFCF diet. A 6-month GFCF diet do not induce significant changes in behavioral symptoms of autism and urinary beta-casomorphin concentrations. Further studies with a long follow-up period similar to ours and including placebo and blinding elements are needed to identify better those respondents to GFCF diets.",2020,A 6-month GFCF diet do not induce significant changes in behavioral symptoms of autism and urinary beta-casomorphin concentrations.,"['children and adolescents diagnosed with ASD and the potential association with urinary beta-casomorphin concentrations', 'Spectrum Disorder', 'Autism Spectrum Disorder (ASD', 'Thirty-seven patients', 'Children and Adolescents Diagnosed with Autism']","['normal diet (including gluten and casein', 'GFCF diet', 'gluten-free and casein-free (GFCF) diets', 'placebo', 'Combined Gluten-Free and Casein-Free Diet', 'intervention (beginning with normal diet or with GFCF diet']","['Questionnaires regarding behavior and autism and dietary adherence', 'behavior disorders', 'urinary beta-casomorphin concentrations', 'Behavior Disorders', 'behavioral symptoms of autism and urinary beta-casomorphin concentrations']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0053398', 'cui_str': 'beta-casomorphins'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1510586', 'cui_str': 'Autism Spectrum Disorders'}, {'cui': 'C4319569', 'cui_str': '37 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0004352', 'cui_str': 'Autism, Early Infantile'}]","[{'cui': 'C0184625', 'cui_str': 'Regular diet'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C2362561', 'cui_str': 'Gluten'}, {'cui': 'C0007332', 'cui_str': 'Caseins'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0336789', 'cui_str': 'Combine'}]","[{'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0004352', 'cui_str': 'Autism, Early Infantile'}, {'cui': 'C0004930', 'cui_str': 'Behavior Disorders'}, {'cui': 'C0053398', 'cui_str': 'beta-casomorphins'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0004941', 'cui_str': 'Behavioral Symptoms'}]",37.0,0.0195205,A 6-month GFCF diet do not induce significant changes in behavioral symptoms of autism and urinary beta-casomorphin concentrations.,"[{'ForeName': 'Pablo José', 'Initials': 'PJ', 'LastName': 'González-Domenech', 'Affiliation': 'Child and Adolescent Mental Health Unit, Virgen de las Nieves University Hospital, Granada, Spain.'}, {'ForeName': 'Francisco', 'Initials': 'F', 'LastName': 'Díaz Atienza', 'Affiliation': 'Child and Adolescent Mental Health Unit, Virgen de las Nieves University Hospital, Granada, Spain.'}, {'ForeName': 'Carlos', 'Initials': 'C', 'LastName': 'García Pablos', 'Affiliation': 'Child and Adolescent Mental Health Unit, Virgen de las Nieves University Hospital, Granada, Spain.'}, {'ForeName': 'María Luisa', 'Initials': 'ML', 'LastName': 'Fernández Soto', 'Affiliation': 'Department of Medicine, University of Granada, Granada, Spain.'}, {'ForeName': 'José María', 'Initials': 'JM', 'LastName': 'Martínez-Ortega', 'Affiliation': 'Department of Psychiatry, University of Granada, Granada, Spain.'}, {'ForeName': 'Luis', 'Initials': 'L', 'LastName': 'Gutiérrez-Rojas', 'Affiliation': 'Department of Psychiatry, University of Granada, Granada, Spain. gutierrezrojasl@hotmail.com.'}]",Journal of autism and developmental disorders,['10.1007/s10803-019-04333-1'] 3108,31776882,"Preschool Peer Social Intervention (PPSI) to Enhance Social Play, Interaction, and Conversation: Study Outcomes.","This RCT study examined efficacy of a preschool peer social intervention (PPSI) in facilitating social engagement of preschoolers with high-functioning ASD (HFASD; N = 65). HFASD participants were randomly assigned by preschool to a 6-month intervention (play, interaction, or conversation) or a waitlisted-treatment-as-usual control group. Trained on-site therapists led the PPSI in preschools, in small (n = 3-4) mixed (HFASD/typical) groups. Results showed that all intervention groups improved over time, each mainly in its own targeted peer-engagement domain, but the control group even deteriorated on some measures. Intervention groups also showed generalization to untrained domains (adaptive skills) and settings (play complexity during preschool activities). It is advised that individualized needs-based holistic peer intervention, comprising all three domains, should be part of early ASD intervention.",2020,Intervention groups also showed generalization to untrained domains (adaptive skills) and settings (play complexity during preschool activities).,"['preschoolers with high-functioning ASD (HFASD; N\u2009=\u200965', 'HFASD participants']","['preschool peer social intervention (PPSI', 'Preschool Peer Social Intervention (PPSI', 'preschool to a 6-month intervention (play, interaction, or conversation) or a waitlisted-treatment-as-usual control group']",['generalization to untrained domains (adaptive skills) and settings (play complexity during preschool activities'],"[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}]","[{'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0017324', 'cui_str': 'Generalization'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}]",,0.015595,Intervention groups also showed generalization to untrained domains (adaptive skills) and settings (play complexity during preschool activities).,"[{'ForeName': 'Nirit', 'Initials': 'N', 'LastName': 'Bauminger-Zviely', 'Affiliation': 'School of Education, Bar-Ilan University, 529002, Ramat Gan, Israel. nirit.bauminger@biu.ac.il.'}, {'ForeName': 'Dganit', 'Initials': 'D', 'LastName': 'Eytan', 'Affiliation': 'School of Education, Bar-Ilan University, 529002, Ramat Gan, Israel.'}, {'ForeName': 'Sagit', 'Initials': 'S', 'LastName': 'Hoshmand', 'Affiliation': 'School of Education, Bar-Ilan University, 529002, Ramat Gan, Israel.'}, {'ForeName': 'Ofira', 'Initials': 'O', 'LastName': 'Rajwan Ben-Shlomo', 'Affiliation': 'School of Education, Bar-Ilan University, 529002, Ramat Gan, Israel.'}]",Journal of autism and developmental disorders,['10.1007/s10803-019-04316-2'] 3109,31353458,Effects of an extracurricular science intervention on elementary school children's epistemic beliefs: A randomized controlled trial.,"BACKGROUND Further developing students' thinking about knowledge and knowing in science (epistemic beliefs) is considered a normative goal of science education in many countries around the world, even for elementary-school-aged children. AIMS The goal of the present study was to introduce and evaluate a new intervention in science education aimed at developing children's epistemic beliefs, epistemic curiosity, and investigative interests. The intervention included an inquiry-based learning approach as well as reflections on epistemic issues because these methods are currently seen as most promising for fostering students' epistemic beliefs. SAMPLE Data were collected from 65 elementary school children in Grades 3 and 4 (58.46% boys, age: M = 8.73, SD = 0.60) who participated in a voluntary extracurricular STEM enrichment programme in south-west Germany. METHODS We investigated the effectiveness of the intervention by applying a randomized block design with a treated control group and repeated measures. The effectiveness of the intervention was analysed via multiple linear regression analyses. RESULTS The results indicated that the children assigned to the intervention developed more sophisticated epistemic beliefs and a higher level of epistemic curiosity than the children assigned to the control condition. No intervention effects were found on investigative interests. CONCLUSIONS The results provide initial evidence for the effectiveness of the intervention and demonstrate that it is possible to improve epistemic beliefs among elementary school children in Grades 3 and 4. The study provides a starting point for understanding how young children develop epistemic beliefs.",2020,The results indicated that the children assigned to the intervention developed more sophisticated epistemic beliefs and a higher level of epistemic curiosity than the children assigned to the control condition.,"[""elementary school children's epistemic beliefs"", 'elementary-school-aged children', 'elementary school children in Grades 3 and 4', '65 elementary school children in Grades 3 and 4 (58.46% boys, age']",['extracurricular science intervention'],"['epistemic beliefs', 'sophisticated epistemic beliefs', 'level of epistemic curiosity']","[{'cui': 'C0260267', 'cui_str': 'School child (occupation)'}, {'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0870221', 'cui_str': 'Boys'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C0036397', 'cui_str': 'Science'}]","[{'cui': 'C0004951', 'cui_str': 'Beliefs'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0010472', 'cui_str': 'Curiosity'}]",,0.0740758,The results indicated that the children assigned to the intervention developed more sophisticated epistemic beliefs and a higher level of epistemic curiosity than the children assigned to the control condition.,"[{'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Schiefer', 'Affiliation': 'Hector Research Institute of Education Sciences and Psychology, University of Tuebingen, Germany.'}, {'ForeName': 'Jessika', 'Initials': 'J', 'LastName': 'Golle', 'Affiliation': 'Hector Research Institute of Education Sciences and Psychology, University of Tuebingen, Germany.'}, {'ForeName': 'Maike', 'Initials': 'M', 'LastName': 'Tibus', 'Affiliation': 'Hector Research Institute of Education Sciences and Psychology, University of Tuebingen, Germany.'}, {'ForeName': 'Evelin', 'Initials': 'E', 'LastName': 'Herbein', 'Affiliation': 'Hector Research Institute of Education Sciences and Psychology, University of Tuebingen, Germany.'}, {'ForeName': 'Verena', 'Initials': 'V', 'LastName': 'Gindele', 'Affiliation': 'Hector Research Institute of Education Sciences and Psychology, University of Tuebingen, Germany.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Trautwein', 'Affiliation': 'Hector Research Institute of Education Sciences and Psychology, University of Tuebingen, Germany.'}, {'ForeName': 'Kerstin', 'Initials': 'K', 'LastName': 'Oschatz', 'Affiliation': 'Hector Research Institute of Education Sciences and Psychology, University of Tuebingen, Germany.'}]",The British journal of educational psychology,['10.1111/bjep.12301'] 3110,31728632,Controlled Delivery of 80 mg Aerosol Furosemide Does Not Achieve Consistent Dyspnea Relief in Patients.,"PURPOSE Aerosol furosemide may be an option to treat refractory dyspnea, though doses, methods of delivery, and outcomes have been variable. We hypothesized that controlled delivery of high dose aerosol furosemide would reduce variability of dyspnea relief in patients with underlying pulmonary disease. METHODS Seventeen patients with chronic exertional dyspnea were recruited. Patients rated recently recalled breathing discomfort on a numerical rating scale (NRS) and the multidimensional dyspnea profile (MDP). They then performed graded exercise using an arm-ergometer. The NRS was completed following each exercise grade, and the MDP was repeated after a pre-defined dyspnea threshold was reached. During separate visits, patients received either aerosol saline or 80 mg of aerosol furosemide in a randomized, double-blind, crossover design. After treatment, graded exercise to the pre-treatment level was repeated, followed by completion of the NRS and MDP. Treatment effect was defined as the difference between pre- and post-treatment NRS at end exercise, expressed in absolute terms as % Full Scale. ""Responders"" were defined as those showing treatment effect ≥ 20% of full scale. RESULTS Final analysis included 15 patients. Neither treatment produced a statistically significant change in NRS and there was no significant difference between treatments (p = 0.45). There were four ""responders"" and one patient whose dyspnea worsened with furosemide; two patients were responders with saline, of whom one also responded to furosemide. No adverse events were reported. CONCLUSIONS High dose controlled delivery aerosol furosemide was not statistically different from saline placebo at reducing exercise-induced dyspnea. However, a clinically meaningful improvement was noted in some patients.",2020,Neither treatment produced a statistically significant change in NRS and there was no significant difference between treatments (p = 0.45).,"['Patients', 'patients with underlying pulmonary disease', 'Seventeen patients with chronic exertional dyspnea were recruited']","['furosemide', 'saline placebo', '80\xa0mg Aerosol Furosemide', 'aerosol saline or 80\xa0mg of aerosol furosemide', 'Aerosol furosemide', 'aerosol furosemide']","['NRS', 'Dyspnea Relief', 'adverse events', 'dyspnea', 'recalled breathing discomfort on a numerical rating scale (NRS) and the multidimensional dyspnea profile (MDP', 'absolute terms as % Full Scale. ', 'exercise-induced dyspnea', 'dyspnea relief']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0024115', 'cui_str': 'Pulmonary Diseases'}, {'cui': 'C0450331', 'cui_str': '17 (qualifier value)'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0231807', 'cui_str': 'Dyspnea on exertion (finding)'}]","[{'cui': 'C0016860', 'cui_str': 'Furosemide'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0001712', 'cui_str': 'Aerosol (substance)'}]","[{'cui': 'C0013404', 'cui_str': 'Breathlessness'}, {'cui': 'C1301676', 'cui_str': 'Relieves (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0035203', 'cui_str': 'Breathing'}, {'cui': 'C2364135', 'cui_str': 'Discomfort (finding)'}, {'cui': 'C0222045'}, {'cui': 'C0052834', 'cui_str': 'B30-MDP'}, {'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}]",,0.240068,Neither treatment produced a statistically significant change in NRS and there was no significant difference between treatments (p = 0.45).,"[{'ForeName': 'Robert W', 'Initials': 'RW', 'LastName': 'Hallowell', 'Affiliation': 'Division of Pulmonary, Critical Care, and Sleep Medicine, Beth Israel Deaconess Medical Center, Boston, MA, 02215, USA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Schwartzstein', 'Affiliation': 'Division of Pulmonary, Critical Care, and Sleep Medicine, Beth Israel Deaconess Medical Center, Boston, MA, 02215, USA.'}, {'ForeName': 'Carl R', 'Initials': 'CR', 'LastName': ""O'Donnell"", 'Affiliation': 'Division of Pulmonary, Critical Care, and Sleep Medicine, Beth Israel Deaconess Medical Center, Boston, MA, 02215, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Sheridan', 'Affiliation': 'Division of Pulmonary, Critical Care, and Sleep Medicine, Beth Israel Deaconess Medical Center, Boston, MA, 02215, USA.'}, {'ForeName': 'Robert B', 'Initials': 'RB', 'LastName': 'Banzett', 'Affiliation': 'Division of Pulmonary, Critical Care, and Sleep Medicine, Beth Israel Deaconess Medical Center, Boston, MA, 02215, USA. dyspnealab@mac.com.'}]",Lung,['10.1007/s00408-019-00292-7'] 3111,31828516,Effect of Using a Wheeled Walker on Physical Activity and Sedentary Time in People with Chronic Obstructive Pulmonary Disease: A Randomised Cross-Over Trial.,"PURPOSE To determine the effects of providing a wheeled walker (WW) for use in the home and community, on daily physical activity (PA) and sedentary time (ST) in people with chronic obstructive pulmonary disease (COPD). METHODS A randomised cross-over study in which participants with COPD characterised by a 6-min walk distance ≤ 450 m, who had recently finished pulmonary rehabilitation, completed two 5-week phases. During one phase, participants were provided a WW to use, whereas during the other phase, the WW was not available. The order of the phases was randomised. For the final week of each phase, measures of PA and ST were collected using wearable devices and health-related quality of life was measured using the Chronic Respiratory Disease Questionnaire (CRDQ). Wheeled walker use was also measured using an odometer attached to the device. RESULTS 17 participants [FEV 1  = median (interquartile range) 33 (25) % pred; ten males] aged mean (SD) 73 (9) years completed the study. Comparing the data collected when the WW was not available for use, the daily step count was greater (mean difference [MD] 707 steps/day (95% confidence interval [CI] 75 to 1340) and participants tended to report less dyspnoea during daily life (MD 0.5 points per item, 95% CI - 0.1 to 1.0) when WW was available. No differences were observed for ST, upright time or stepping time. The WW was used over 4504 m/week (95% CI 2746 to 6262). CONCLUSION These data demonstrated that, when provided to selected patients with COPD, WWs increased daily step count. CLINICAL TRIAL REGISTRATION NUMBER ACTRN12609000332224.",2020,"No differences were observed for ST, upright time or stepping time.","['17 participants [FEV 1 \u2009=\u2009median (interquartile range) 33 (25) % pred; ten males] aged mean (SD) 73 (9) years completed the study', 'people with chronic obstructive pulmonary disease (COPD', 'People with Chronic Obstructive Pulmonary Disease', 'participants with COPD characterised by a 6-min walk distance ≤\u2009450\xa0m, who had recently finished pulmonary rehabilitation, completed two 5-week phases']",['Wheeled Walker'],"['daily physical activity (PA) and sedentary time (ST', 'Chronic Respiratory Disease Questionnaire (CRDQ', 'dyspnoea during daily life', 'ST, upright time or stepping time', 'Physical Activity and Sedentary Time']","[{'cui': 'C0849974', 'cui_str': 'FEV 1'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0024117', 'cui_str': 'Chronic Obstructive Lung Disease'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0429886', 'cui_str': 'Walking distance (observable entity)'}, {'cui': 'C3844104', 'cui_str': 'Four hundred and fifty'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C1706059', 'cui_str': 'Finish - dosing instruction imperative'}, {'cui': 'C0199529', 'cui_str': 'Pulmonary rehabilitation (regime/therapy)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}]","[{'cui': 'C0043016', 'cui_str': 'Walkers'}]","[{'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C3164900', 'cui_str': 'Chronic respiratory disease questionnaire (assessment scale)'}, {'cui': 'C0013404', 'cui_str': 'Breathlessness'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C1261552', 'cui_str': 'Step'}]",,0.156942,"No differences were observed for ST, upright time or stepping time.","[{'ForeName': 'Kylie', 'Initials': 'K', 'LastName': 'Hill', 'Affiliation': 'School of Physiotherapy and Exercise Science, Faculty of Health Sciences, Curtin University, GPO Box U1987, Perth, WA, 6845, Australia. K.Hill@curtin.edu.au.'}, {'ForeName': 'L W Cindy', 'Initials': 'LWC', 'LastName': 'Ng', 'Affiliation': 'School of Physiotherapy and Exercise Science, Faculty of Health Sciences, Curtin University, GPO Box U1987, Perth, WA, 6845, Australia.'}, {'ForeName': 'Nola', 'Initials': 'N', 'LastName': 'Cecins', 'Affiliation': 'Physiotherapy Department, Sir Charles Gairdner Hospital, Perth, WA, Australia.'}, {'ForeName': 'Vittoria R', 'Initials': 'VR', 'LastName': 'Formico', 'Affiliation': 'Physiotherapy Department, Faculdade de Ciências E Tecnologia, Universidade Estadual Paulista (UNESP), Presidente Prudente, Brazil.'}, {'ForeName': 'Vinicius', 'Initials': 'V', 'LastName': 'Cavalheri', 'Affiliation': 'School of Physiotherapy and Exercise Science, Faculty of Health Sciences, Curtin University, GPO Box U1987, Perth, WA, 6845, Australia.'}, {'ForeName': 'Sue C', 'Initials': 'SC', 'LastName': 'Jenkins', 'Affiliation': 'School of Physiotherapy and Exercise Science, Faculty of Health Sciences, Curtin University, GPO Box U1987, Perth, WA, 6845, Australia.'}]",Lung,['10.1007/s00408-019-00297-2'] 3112,30611715,A pilot cluster-randomised study to increase sleep duration by decreasing electronic media use at night and caffeine consumption in adolescents.,"OBJECTIVE Bedtime electronic media use and caffeine consumption are risk factors for insufficient sleep and poor sleep quality during adolescence, which are in turn risk factors for mental wellbeing. Our study tested the effectiveness of a brief school-based psychoeducative intervention to primarily increase sleep duration, by decreasing bedtime electronic media use and caffeine consumption. Secondary outcomes included improving sleep quality and difficulties, daytime tiredness, and mental wellbeing. METHOD A pilot cluster-randomised controlled study was conducted involving a 25-min psychoeducative school-based intervention combined with parent information. 352 adolescents from seven schools participated (Intervention Group/IG = 192 students vs. Control Group/CG = 160 students; age: Mean = 15.09 years; SD = 1.65 years; Females = 163). The intervention included information on the importance of sleep and good sleep hygiene habits, particularly emphasizing behavioural rules of avoiding electronic media use at night and evening-time caffeine consumption. A leaflet containing the rules was also sent to parents of IG participants. Baseline and post-intervention sessions were held approximately four weeks apart. RESULTS Multilevel analyses revealed a significant but modest decrease in electronic media use for participants in the IG versus CG, but showed no effect on caffeine consumption or sleep duration. Moreover, the intervention did not impact any secondary outcome. CONCLUSIONS Findings indicate the potential effectiveness of a short and easily administrable intervention to decrease electronic media use at night, which may be incorporated into school curricula and standardised for wider use in primary prevention. However, no further benefits of the intervention were found.",2019,"Multilevel analyses revealed a significant but modest decrease in electronic media use for participants in the IG versus CG, but showed no effect on caffeine consumption or sleep duration.","['Mean\xa0=\xa015.09 years; SD\xa0=\xa01.65 years; Females\xa0=\xa0163', '352 adolescents from seven schools participated (Intervention Group/IG\xa0=\xa0192 students vs. Control Group/CG\xa0=\xa0160 students; age', 'adolescents']","['electronic media use at night and caffeine consumption', '25-min psychoeducative school-based intervention combined with parent information', 'brief school-based psychoeducative intervention']","['sleep quality and difficulties, daytime tiredness, and mental wellbeing', 'caffeine consumption or sleep duration', 'electronic media']","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4517623', 'cui_str': '192'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C4281784', 'cui_str': 'Electronics'}, {'cui': 'C0449892', 'cui_str': 'Medium used (attribute)'}, {'cui': 'C0240526', 'cui_str': 'Night time (qualifier value)'}, {'cui': 'C0948365', 'cui_str': 'Caffeine consumption'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}]","[{'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C1299586', 'cui_str': 'Difficulty'}, {'cui': 'C0332169', 'cui_str': 'Daytime (qualifier value)'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0948365', 'cui_str': 'Caffeine consumption'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C4281784', 'cui_str': 'Electronics'}, {'cui': 'C0439536', 'cui_str': 'Medium (qualifier value)'}]",352.0,0.0310145,"Multilevel analyses revealed a significant but modest decrease in electronic media use for participants in the IG versus CG, but showed no effect on caffeine consumption or sleep duration.","[{'ForeName': 'Ahuti', 'Initials': 'A', 'LastName': 'Das-Friebel', 'Affiliation': 'University of Warwick, Department of Psychology, Coventry, United Kingdom.'}, {'ForeName': 'Nadine', 'Initials': 'N', 'LastName': 'Perkinson-Gloor', 'Affiliation': 'University of Basel, Department of Psychology, Basel, Switzerland.'}, {'ForeName': 'Serge', 'Initials': 'S', 'LastName': 'Brand', 'Affiliation': 'University of Basel, Psychiatric Clinics, Center for Affective, Stress, and Sleep Disorders, Basel, Switzerland; University of Basel, Department of Sport, Exercise and Health, Division of Sport and Psychosocial Health, Basel, Switzerland; Kermanshah University of Medical Sciences (KUMS), Sleep Disorders Research Center, Kermanshah, Iran; Kermanshah University of Medical Sciences (KUMS), Substance Abuse Prevention Research Center, Kermanshah, Iran.'}, {'ForeName': 'Julia F', 'Initials': 'JF', 'LastName': 'Dewald-Kaufmann', 'Affiliation': 'Hochschule Fresenius, University of Applied Sciences, Munich, Germany; Department of Psychiatry and Psychotherapy, University Hospital, Ludwig-Maximilans-University Munich, Germany.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Grob', 'Affiliation': 'University of Basel, Department of Psychology, Basel, Switzerland.'}, {'ForeName': 'Dieter', 'Initials': 'D', 'LastName': 'Wolke', 'Affiliation': 'University of Warwick, Department of Psychology, Coventry, United Kingdom.'}, {'ForeName': 'Sakari', 'Initials': 'S', 'LastName': 'Lemola', 'Affiliation': 'University of Warwick, Department of Psychology, Coventry, United Kingdom. Electronic address: s.lemola@warwick.ac.uk.'}]",Sleep medicine,['10.1016/j.sleep.2018.11.010'] 3113,32034285,Response-adapted lenalidomide maintenance in newly diagnosed myeloma: results from the phase III GMMG-MM5 trial.,"The MM5 trial aimed at demonstrating a progression-free survival (PFS) difference in continued vs. response-adapted (in case of complete response, CR) lenalidomide (LEN) maintenance therapy (MT) in newly diagnosed, transplant-eligible multiple myeloma (MM). Patients were equally randomized to receive induction therapy with PAd (bortezomib/doxorubicin/dexamethasone) or VCD (bortezomib/cyclophosphamide/dexamethasone), high-dose melphalan and autologous blood stem cell transplantation, and LEN consolidation, followed by either LEN MT for a fixed duration of 2 years (LEN-2Y) or until achievement of CR (LEN-CR, intention-to-treat population n = 502): arms A1:PAd + LEN-2Y (n = 125), B1:PAd + LEN-CR (n = 126), A2:VCD + LEN-2Y (n = 126), B2:VCD + LEN-CR (n = 125). In the LEN-CR group (B1 + B2), n = 88/17.5% patients did not start or discontinued LEN MT due to CR. There was no PFS (p = 0.60, primary endpoint) nor overall survival (OS) (p = 0.15) difference between the four study arms. On pooled LEN MT strategies, OS (hazard ratio, hazard ratio [HR] = 1.42, p = 0.03) but not PFS (HR = 1.15, p = 0.20) was shorter in LEN-CR (B1 + B2) vs. LEN-2Y (A1 + A2) groups. PFS was shortened on landmark analyses from the start of LEN MT in patients being in CR in the LEN-CR group (LEN-CR vs. LEN-2Y, HR = 1.84, p = 0.02). OS from first progression was shortened in the LEN-CR vs. LEN-2Y group (HR = 1.60, p = 0.01). LEN MT should be applied beyond CR for at least 2 years.",2020,"There was no PFS (p = 0.60, primary endpoint) nor overall survival (OS) (p = 0.15) difference between the four study arms.","['newly diagnosed myeloma', 'newly diagnosed, transplant-eligible multiple myeloma (MM']","['Response-adapted lenalidomide maintenance', 'CR) lenalidomide (LEN) maintenance therapy (MT', 'induction therapy with PAd (bortezomib/doxorubicin/dexamethasone) or VCD (bortezomib/cyclophosphamide/dexamethasone), high-dose melphalan and autologous blood stem cell transplantation, and LEN consolidation, followed by either LEN MT for a fixed duration of 2 years (LEN-2Y) or until achievement of CR (LEN-CR, intention-to-treat population n\u2009=\u2009502): arms A1:PAd\u2009+\u2009LEN-2Y (n\u2009=\u2009125), B1:PAd\u2009+\u2009LEN-CR (n\u2009=\u2009126), A2:VCD\u2009+\u2009LEN-2Y (n\u2009=\u2009126), B2:VCD\u2009+\u2009LEN-CR']","['PFS', 'overall survival (OS']","[{'cui': 'C0026764', 'cui_str': 'Myelomatosis'}, {'cui': 'C0332835', 'cui_str': 'Grafts'}]","[{'cui': 'C1144149', 'cui_str': 'lenalidomide'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C0677908', 'cui_str': 'Maintenance therapy'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0441601', 'cui_str': 'Padding (qualifier value)'}, {'cui': 'C1176309', 'cui_str': 'bortezomib'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}, {'cui': 'C0025241', 'cui_str': 'Melphalan'}, {'cui': 'C0439859', 'cui_str': 'Autologous (qualifier value)'}, {'cui': 'C0005768'}, {'cui': 'C1504389', 'cui_str': 'Stem Cell Transplantation'}, {'cui': 'C0702116', 'cui_str': 'Consolidation (morphologic abnormality)'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0443218', 'cui_str': 'Fixed (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C4319551', 'cui_str': 'One hundred and twenty-five'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",,0.0511233,"There was no PFS (p = 0.60, primary endpoint) nor overall survival (OS) (p = 0.15) difference between the four study arms.","[{'ForeName': 'Hartmut', 'Initials': 'H', 'LastName': 'Goldschmidt', 'Affiliation': 'Department of Internal Medicine V, University Hospital Heidelberg, Heidelberg, Germany. hartmut.goldschmidt@med.uni-heidelberg.de.'}, {'ForeName': 'Elias K', 'Initials': 'EK', 'LastName': 'Mai', 'Affiliation': 'Department of Internal Medicine V, University Hospital Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Dürig', 'Affiliation': 'Department of Hematology, University Hospital Essen, Essen, Germany.'}, {'ForeName': 'Christof', 'Initials': 'C', 'LastName': 'Scheid', 'Affiliation': 'Department of Internal Medicine I, University Hospital Cologne, Cologne, Germany.'}, {'ForeName': 'Katja C', 'Initials': 'KC', 'LastName': 'Weisel', 'Affiliation': 'Department of Hematology, Oncology and Immunology, University Hospital Tübingen, Tübingen, Germany.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Kunz', 'Affiliation': 'Division of Biostatistics, German Cancer Research Center (DKFZ), Heidelberg, Germany.'}, {'ForeName': 'Uta', 'Initials': 'U', 'LastName': 'Bertsch', 'Affiliation': 'Department of Internal Medicine V, University Hospital Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Hielscher', 'Affiliation': 'Division of Biostatistics, German Cancer Research Center (DKFZ), Heidelberg, Germany.'}, {'ForeName': 'Maximilian', 'Initials': 'M', 'LastName': 'Merz', 'Affiliation': 'Department of Internal Medicine V, University Hospital Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Munder', 'Affiliation': 'Department of Internal Medicine III, University Medical Center Mainz, Mainz, Germany.'}, {'ForeName': 'Hans-Walter', 'Initials': 'HW', 'LastName': 'Lindemann', 'Affiliation': 'Department of Hematology and Oncology, Katholisches Krankenhaus Hagen, Hagen, Germany.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Hügle-Dörr', 'Affiliation': 'Department of Internal Medicine V, University Hospital Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Tichy', 'Affiliation': 'Division of Biostatistics, German Cancer Research Center (DKFZ), Heidelberg, Germany.'}, {'ForeName': 'Nicola', 'Initials': 'N', 'LastName': 'Giesen', 'Affiliation': 'Department of Internal Medicine V, University Hospital Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Dirk', 'Initials': 'D', 'LastName': 'Hose', 'Affiliation': 'Department of Internal Medicine V, University Hospital Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Anja', 'Initials': 'A', 'LastName': 'Seckinger', 'Affiliation': 'Department of Internal Medicine V, University Hospital Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Stefanie', 'Initials': 'S', 'LastName': 'Huhn', 'Affiliation': 'Department of Internal Medicine V, University Hospital Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Steffen', 'Initials': 'S', 'LastName': 'Luntz', 'Affiliation': 'Coordination Centre for Clinical Trials (KKS), Heidelberg, Germany.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Jauch', 'Affiliation': 'Institute of Human Genetics, University of Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Ahmet', 'Initials': 'A', 'LastName': 'Elmaagacli', 'Affiliation': 'Department of Hematology and Oncology, Asklepios Hospital Hamburg St. Georg, Hamburg, Germany.'}, {'ForeName': 'Bernhard', 'Initials': 'B', 'LastName': 'Rabold', 'Affiliation': 'Coordination Centre for Clinical Trials (KKS), Heidelberg, Germany.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Fuhrmann', 'Affiliation': 'Department of Hematology and Oncology, Helios Hospital Berlin Buch, Berlin, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Brossart', 'Affiliation': 'University Hospital Bonn, Bonn, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Goerner', 'Affiliation': 'Department of Hematology, Oncology and Palliative Care, Klinikum Bielefeld, Bielefeld, Germany.'}, {'ForeName': 'Helga', 'Initials': 'H', 'LastName': 'Bernhard', 'Affiliation': 'Internal Medicine V, Klinikum Darmstadt, Darmstadt, Germany.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Hoffmann', 'Affiliation': 'Medical Clinic A, Klinikum Ludwigshafen, Ludwigshafen, Germany.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Hillengass', 'Affiliation': 'Department of Internal Medicine V, University Hospital Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Marc S', 'Initials': 'MS', 'LastName': 'Raab', 'Affiliation': 'Department of Internal Medicine V, University Hospital Heidelberg, Heidelberg, Germany.'}, {'ForeName': 'Igor W', 'Initials': 'IW', 'LastName': 'Blau', 'Affiliation': 'Medical Clinic, Charité University Medicine Berlin, Berlin, Germany.'}, {'ForeName': 'Mathias', 'Initials': 'M', 'LastName': 'Hänel', 'Affiliation': 'Department of Internal Medicine III, Klinikum Chemnitz, Chemnitz, Germany.'}, {'ForeName': 'Hans J', 'Initials': 'HJ', 'LastName': 'Salwender', 'Affiliation': 'Department of Hematology and Oncology, Asklepios Hospital Hamburg Altona, Hamburg, Germany.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Leukemia,['10.1038/s41375-020-0724-1'] 3114,30560426,"The Effects of Synbiotic Supplementation on Metabolic Status in Diabetic Patients Undergoing Hemodialysis: a Randomized, Double-Blinded, Placebo-Controlled Trial.","This study was conducted to evaluate the effects of synbiotic supplementation on metabolic profiles in diabetic patients undergoing hemodialysis (HD). This randomized, double-blinded, placebo-controlled clinical trial was performed in 60 diabetic HD patients. Participants were randomly assigned into two groups to receive either synbiotic capsule, containing Lactobacillus acidophilus, Lactobacillus casei, and Bifidobacterium bifidum (2 × 10 9  CFU/g each), plus 0.8 g/day of inulin (n = 30) or placebo (n = 30) for 12 weeks. Synbiotic supplementation significantly decreased fasting plasma glucose (β - 13.56 mg/dL; 95% CI, - 23.82, - 3.30; P = 0.01), insulin levels (β - 5.49 μIU/mL; 95% CI, - 6.92, - 4.05; P < 0.001), and insulin resistance (β - 2.25; 95% CI, - 3.02, - 1.48; P < 0.001), while increased the quantitative insulin sensitivity check index (β 0.02; 95% CI, 0.01, 0.02; P < 0.001) compared with the placebo. Additionally, synbiotic intake resulted in a significant reduction in high-sensitivity C-reactive protein (β - 2930.48 ng/mL; 95% CI, - 3741.15, - 2119.80; P < 0.001) and malondialdehyde levels (β - 0.60 μmol/L; 95% CI, - 0.99, - 0.20; P = 0.003). Moreover, we found a significant increase in total antioxidant capacity (β 142.99 mmol/L; 95% CI, 61.72, 224.25; P = 0.001) and total glutathione levels (β 131.11 μmol/L; 95% CI, 89.35, 172.87; P < 0.001) in the synbiotic group compared with the placebo group. Overall, synbiotic supplementation for 12 weeks had beneficial effects on glycemic control, biomarkers of inflammation, and oxidative stress in diabetic patients under HD. This study was registered in the Iranian website (www.irct.ir) for registration of clinical trials (http://www.irct.ir: IRCT2017090133941N17). http://www.irct.ir: IRCT2017090133941N17.",2019,"Overall, synbiotic supplementation for 12 weeks had beneficial effects on glycemic control, biomarkers of inflammation, and oxidative stress in diabetic patients under HD.","['60 diabetic HD patients', 'diabetic patients undergoing hemodialysis (HD', 'Diabetic Patients Undergoing Hemodialysis', 'diabetic patients under HD']","['placebo', 'Synbiotic supplementation', 'Placebo', 'Synbiotic Supplementation', 'synbiotic capsule, containing Lactobacillus acidophilus, Lactobacillus casei, and Bifidobacterium bifidum (2', 'synbiotic supplementation']","['total glutathione levels', 'quantitative insulin sensitivity check index', 'insulin resistance', 'high-sensitivity C-reactive protein', 'malondialdehyde levels', 'Metabolic Status', 'metabolic profiles', 'insulin levels', 'total antioxidant capacity', 'glycemic control, biomarkers of inflammation, and oxidative stress', 'fasting plasma glucose']","[{'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2936470', 'cui_str': 'Synbiotics'}, {'cui': 'C4319574', 'cui_str': 'Capsule'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0022939', 'cui_str': 'Lactobacillus acidophilus'}, {'cui': 'C0022940', 'cui_str': 'Lactobacillus casei'}, {'cui': 'C0314974', 'cui_str': 'Bifidobacterium bifidum'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0017817', 'cui_str': 'Glutathione'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0392762', 'cui_str': 'Quantitative (qualifier value)'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0242606', 'cui_str': 'Oxidative Stress'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma (procedure)'}]",60.0,0.756403,"Overall, synbiotic supplementation for 12 weeks had beneficial effects on glycemic control, biomarkers of inflammation, and oxidative stress in diabetic patients under HD.","[{'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Soleimani', 'Affiliation': 'Department of Internal Medicine, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Motamedzadeh', 'Affiliation': 'Department of Internal Medicine, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Malihe', 'Initials': 'M', 'LastName': 'Zarrati Mojarrad', 'Affiliation': 'Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Fereshteh', 'Initials': 'F', 'LastName': 'Bahmani', 'Affiliation': 'Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Elaheh', 'Initials': 'E', 'LastName': 'Amirani', 'Affiliation': 'Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Vahidreza', 'Initials': 'V', 'LastName': 'Ostadmohammadi', 'Affiliation': 'Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Tajabadi-Ebrahimi', 'Affiliation': 'Faculty member of Science department, science faculty, Islamic Azad University Tehran Central Branch, Tehran, Iran.'}, {'ForeName': 'Zatollah', 'Initials': 'Z', 'LastName': 'Asemi', 'Affiliation': 'Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences, Kashan, Iran. asemi_r@yahoo.com.'}]",Probiotics and antimicrobial proteins,['10.1007/s12602-018-9499-3'] 3115,31785395,Biological motion during inflammation in humans.,"Biological motion is a powerful perceptual cue that can reveal important information about the inner state of an individual. Activation of inflammatory processes likely leads to changes in gait, posture, and mobility patterns, but the specific characteristics of inflammation-related biological motion have not been characterized. The aim of this study was to determine the effect of inflammation on gait and motion in humans. Systemic inflammation was induced in 19 healthy volunteers with an intravenous injection of lipopolysaccharide (2 ng/kg body weight). Biological motion parameters (walking speed, stride length and time, arm, leg, head, and shoulder angles) were assessed during a walking paradigm and the timed-up-and-go test. Cytokine concentrations, body temperature, and sickness symptoms were measured. During inflammation, compared to placebo, participants exhibited shorter, slower, and wider strides, less arm extension, less knee flexion, and a more downward-tilting head while walking. They were also slower and took a shorter first step in the timed-up-and-go test. Higher interleukin-6 concentrations, stronger sickness symptoms, and lower body temperature predicted the inflammation-related alterations in biological motion. These findings show that biological motion contains clear information about the inflammatory status of an individual, and may be used by peers or artificial intelligence to recognize that someone is sick or contagious.",2020,"Higher interleukin-6 concentrations, stronger sickness symptoms, and lower body temperature predicted the inflammation-related alterations in biological motion.","['19 healthy volunteers with an intravenous injection of', 'humans']","['placebo', 'lipopolysaccharide']","['Biological motion parameters (walking speed, stride length and time, arm, leg, head, and shoulder angles', 'Higher interleukin-6 concentrations, stronger sickness symptoms', 'Systemic inflammation', 'slower, and wider strides, less arm extension, less knee flexion', 'Cytokine concentrations, body temperature, and sickness symptoms']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0021494', 'cui_str': 'Intravenous Injections'}, {'cui': 'C0086418', 'cui_str': 'Humans'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0023810', 'cui_str': 'Lipoglycans'}]","[{'cui': 'C4553887', 'cui_str': 'Biologic Drugs'}, {'cui': 'C0687704', 'cui_str': 'Motions (qualifier value)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C2009910', 'cui_str': 'Gait Speed'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C0018670', 'cui_str': 'Head'}, {'cui': 'C0037004', 'cui_str': 'Shoulder'}, {'cui': 'C0205143', 'cui_str': 'Angular (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0442821', 'cui_str': 'Strong (qualifier value)'}, {'cui': 'C0221423', 'cui_str': 'Illness (finding)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0231448', 'cui_str': 'Extension (qualifier value)'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0231452', 'cui_str': 'Flexion, function (observable entity)'}, {'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}, {'cui': 'C0886414', 'cui_str': 'Body temperature'}]",19.0,0.0530894,"Higher interleukin-6 concentrations, stronger sickness symptoms, and lower body temperature predicted the inflammation-related alterations in biological motion.","[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Lasselin', 'Affiliation': 'Stress Research Institute, Stockholm University, 10691 Stockholm, Sweden; Department of Clinical Neuroscience, Division for Psychology, Karolinska Institutet, Nobels väg 9, 17177 Stockholm, Sweden; Institute of Medical Psychology and Behavioral Immunobiology, University Hospital Essen, Hufelandstrasse 55, 45122 Essen, Germany. Electronic address: julie.lasselin@su.se.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Sundelin', 'Affiliation': 'Stress Research Institute, Stockholm University, 10691 Stockholm, Sweden; Department of Clinical Neuroscience, Division for Psychology, Karolinska Institutet, Nobels väg 9, 17177 Stockholm, Sweden; Department of Psychology, New York University, 6 Washington Place, 10003 New York, NY, USA.'}, {'ForeName': 'P M', 'Initials': 'PM', 'LastName': 'Wayne', 'Affiliation': ""Osher Center for Integrative Medicine, Division of Preventive Medicine, Brigham and Women's Hospital and Harvard Medical School, 75 Francis Stress, 02115 Boston, MA, USA.""}, {'ForeName': 'M J', 'Initials': 'MJ', 'LastName': 'Olsson', 'Affiliation': 'Department of Clinical Neuroscience, Division for Psychology, Karolinska Institutet, Nobels väg 9, 17177 Stockholm, Sweden.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Paues Göranson', 'Affiliation': 'Department of Clinical Sciences, Danderyd Hospital, Karolinska Institutet, 18288 Stockholm, Sweden.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Axelsson', 'Affiliation': 'Stress Research Institute, Stockholm University, 10691 Stockholm, Sweden; Department of Clinical Neuroscience, Division for Psychology, Karolinska Institutet, Nobels väg 9, 17177 Stockholm, Sweden; Osher Center for Integrative Medicine, Karolinska Institutet, Nobels väg 9, 17177 Stockholm, Sweden.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Lekander', 'Affiliation': 'Stress Research Institute, Stockholm University, 10691 Stockholm, Sweden; Department of Clinical Neuroscience, Division for Psychology, Karolinska Institutet, Nobels väg 9, 17177 Stockholm, Sweden; Osher Center for Integrative Medicine, Karolinska Institutet, Nobels väg 9, 17177 Stockholm, Sweden.'}]","Brain, behavior, and immunity",['10.1016/j.bbi.2019.11.019'] 3116,30954442,Oxytocin Selectively Improves Empathic Accuracy: A Replication in Men and Novel Insights in Women.,"BACKGROUND Previously, oxytocin, a neuropeptide implicated in human social cognition and behavior, was shown to improve people's ability to dynamically track another's emotional state (""empathic accuracy"") specifically for less socially proficient individuals-i.e., healthy adults who score higher on the Autism Spectrum Quotient (AQ); conversely, oxytocin had no effect on empathic accuracy for more socially proficient individuals, who performed well following oxytocin and placebo. Here, we aimed to replicate this finding and investigate the effects of oxytocin on empathic accuracy in women. To date, women have been seriously underrepresented in human oxytocin research, and it is not known whether the effects observed in male-only samples apply to women. METHODS In this randomized, double-blind, placebo-controlled, crossover trial, we administered 24 IU intranasal oxytocin (and, on a separate occasion, a matching placebo) to 31 men and 40 women and then measured empathic accuracy. AQ was assessed at baseline (prior to drug administration). RESULTS Replicating a 2010 study by Bartz et al., oxytocin selectively improved empathic accuracy for men who scored higher on the AQ, whereas oxytocin did not benefit their lower AQ counterparts. Conversely, we found no effect of oxytocin on empathic accuracy for women (regardless of their AQ score). CONCLUSIONS In addition to speaking to reliability, this research is important given interest in using oxytocin to augment social functioning in some psychiatric disorders marked by social cognitive impairments. More generally, this research adds to our understanding of the biological systems that support human sociality and provides further evidence for the role of oxytocin therein.",2019,", oxytocin selectively improved empathic accuracy for men who scored higher on the AQ, whereas oxytocin did not benefit their lower AQ counterparts.","['Replicating a 2010 study by Bartz et', 'women', 'Men and Novel Insights in Women', '31 men and 40 women and then measured empathic accuracy']","['placebo', '24 IU intranasal oxytocin', 'Oxytocin', 'oxytocin and placebo', 'oxytocin']","['empathic accuracy', 'AQ', 'Empathic Accuracy']","[{'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0233820', 'cui_str': 'Self-understanding'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0442118', 'cui_str': 'Intranasal approach (qualifier value)'}, {'cui': 'C0030095', 'cui_str': 'Oxytocin'}]",[],,0.285924,", oxytocin selectively improved empathic accuracy for men who scored higher on the AQ, whereas oxytocin did not benefit their lower AQ counterparts.","[{'ForeName': 'Jennifer A', 'Initials': 'JA', 'LastName': 'Bartz', 'Affiliation': 'Department of Psychology, McGill University, Montreal, Quebec, Canada. Electronic address: jennifer.bartz@mcgill.ca.'}, {'ForeName': 'Jonas P', 'Initials': 'JP', 'LastName': 'Nitschke', 'Affiliation': 'Department of Psychology, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Sonia A', 'Initials': 'SA', 'LastName': 'Krol', 'Affiliation': 'Department of Psychology, McGill University, Montreal, Quebec, Canada.'}, {'ForeName': 'Pierre-Paul', 'Initials': 'PP', 'LastName': 'Tellier', 'Affiliation': 'Department of Family Medicine, McGill University, Montreal, Quebec, Canada.'}]",Biological psychiatry. Cognitive neuroscience and neuroimaging,['10.1016/j.bpsc.2019.01.014'] 3117,31277966,Responder Analyses from a Phase 2b Dose-Ranging Study of Bremelanotide.,"BACKGROUND Responder analyses are used to determine whether changes that occur during a clinical trial are clinically meaningful; for subjective endpoints such as those based on patient-reported outcomes (PROs), responder analyses are particularly useful. AIM To identify the minimal clinically important difference (MCID) for selected scores on questionnaires assessing female sexual functioning and to use these differences to analyze the response in a large, controlled, phase 2b, dose-finding study of bremelanotide in premenopausal women with hypoactive sexual desire disorder (HSDD) and mixed HSDD/female sexual arousal disorder (FSAD). METHODS The responder analyses were performed for the change from baseline to end of study for a total of 7 endpoints. Each PRO endpoint was assessed using at least 1 of 4 types of responder analyses: a planned analysis anchored to MCIDs based on expert estimates (historical anchors); post hoc analyses based on self-reported global benefit; receiver operating characteristic (ROC) curves; and cumulative distribution function. The prespecified analysis groups were all female sexual dysfunction (FSD)-based diagnoses (all study participants), those with HSDD alone, and a combined group of those with FSAD alone plus those with mixed HSDD/FSAD. Post hoc analyses were also performed for subjects with mixed HSDD/FSAD with a primary diagnosis of HSDD. OUTCOMES MCIDs based on the ROC curves for changes in Female Sexual Function Index-desire domain, Female Sexual Distress Scale-Desire/Arousal/Orgasm (FSDS-DAO) total score, FSDS-DAO item 13 and 14 scores, and number of satisfying sexual events. RESULTS Outcomes matched those based on input from clinical experts. For all 7 endpoints, responder rates at the 1.75 mg dose in the overall modified intention-to-treat population achieved statistical significance compared with placebo (P ≤ .03). CLINICAL IMPLICATIONS These responder definitions were subsequently used in the bremelanotide phase 3 registration studies (RECONNECT) that evaluated the safety and efficacy of the bremelanotide 1.75 mg subcutaneous dose in premenopausal women with HSDD. STRENGTHS & LIMITATIONS MCIDs for this study were based on changes from a single-blind phase to account for changes due to the placebo effect. These analyses were restricted to a study population composed only of premenopausal women with a clinical diagnosis of HSDD and/or FSAD and were based on data from the same clinical trial. CONCLUSION Bremelanotide was safe and well tolerated and demonstrated significant improvement in efficacy vs placebo in the phase 2b trial. The multiple responder analyses offer a valuable approach for determining clinically important effects of bremelanotide for HSDD and FSAD. Althof S, Derogatis LR, Greenberg S, et al. Responder Analyses from a Phase 2b Dose-Ranging Study of Bremelanotide. J Sex Med 2019;16:1226-1235.",2019,"OUTCOMES MCIDs based on the ROC curves for changes in Female Sexual Function Index-desire domain, Female Sexual Distress Scale-Desire/Arousal/Orgasm (FSDS-DAO) total score, FSDS-DAO item 13 and 14 scores, and number of satisfying sexual events. ","['premenopausal women with HSDD', 'premenopausal women with a clinical diagnosis of HSDD and/or FSAD and were based on data from the same clinical trial', 'subjects with mixed HSDD/FSAD with a primary diagnosis of HSDD', 'premenopausal women with hypoactive sexual desire disorder (HSDD) and mixed HSDD/female sexual arousal disorder (FSAD']","['bremelanotide', 'FSAD alone plus those with mixed HSDD/FSAD', 'placebo']","['Female Sexual Function Index-desire domain, Female Sexual Distress Scale-Desire/Arousal/Orgasm (FSDS-DAO) total score, FSDS-DAO item 13 and 14 scores, and number of satisfying sexual events', 'safety and efficacy', 'safe and well tolerated', 'responder rates', 'efficacy', 'global benefit; receiver operating characteristic (ROC) curves; and cumulative distribution function']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0332140', 'cui_str': 'Clinical diagnosis (contextual qualifier) (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0020594', 'cui_str': 'Hypoactive Sexual Desire Disorder'}, {'cui': 'C0015786', 'cui_str': 'Female sexual arousal disorder (disorder)'}]","[{'cui': 'C1721339', 'cui_str': 'bremelanotide'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0278098', 'cui_str': 'Female sexual function (observable entity)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0222045'}, {'cui': 'C0003808', 'cui_str': 'Arousal'}, {'cui': 'C0029260', 'cui_str': 'Orgasm'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}, {'cui': 'C0037775', 'cui_str': 'Distributions (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}]",,0.106031,"OUTCOMES MCIDs based on the ROC curves for changes in Female Sexual Function Index-desire domain, Female Sexual Distress Scale-Desire/Arousal/Orgasm (FSDS-DAO) total score, FSDS-DAO item 13 and 14 scores, and number of satisfying sexual events. ","[{'ForeName': 'Stanley', 'Initials': 'S', 'LastName': 'Althof', 'Affiliation': 'Case Western Reserve University School of Medicine, Department of Psychiatry, Cleveland, OH, USA. Electronic address: Stanley.Althof@case.edu.'}, {'ForeName': 'Leonard R', 'Initials': 'LR', 'LastName': 'Derogatis', 'Affiliation': 'Maryland Center for Sexual Health, Lutherville, MD, USA.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Greenberg', 'Affiliation': 'S. Greenberg Statistical Consulting Inc, Berkeley, CA, USA.'}, {'ForeName': 'Anita H', 'Initials': 'AH', 'LastName': 'Clayton', 'Affiliation': 'University of Virginia, Department of Psychiatry, Charlottesville, VA, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Jordan', 'Affiliation': 'Palatin Technologies, Inc, Cranbury, NJ, USA.'}, {'ForeName': 'Johna', 'Initials': 'J', 'LastName': 'Lucas', 'Affiliation': 'Palatin Technologies, Inc, Cranbury, NJ, USA.'}, {'ForeName': 'Carl', 'Initials': 'C', 'LastName': 'Spana', 'Affiliation': 'Palatin Technologies, Inc, Cranbury, NJ, USA.'}]",The journal of sexual medicine,['10.1016/j.jsxm.2019.05.012'] 3118,32036375,Efficacy of a Specialized Group Intervention for Compulsive Exercise in Inpatients with Anorexia Nervosa: A Randomized Controlled Trial.,"INTRODUCTION Treatment of compulsive exercise is recognized as a key unmet challenge in the treatment of anorexia nervosa (AN). To address this challenge, we developed the manualized group intervention ""healthy exercise behavior"" (HEB). This study evaluates the efficacy of HEB for the reduction of compulsive exercise as add-on to routine inpatient treatment (treatment as usual [TAU]) in a randomized controlled trial. METHODS Two hundred and seven adolescent and adult female inpatients with (atypical) AN were randomly allocated to TAU or to additional participation in HEB (TAU + HEB). HEB integrates elements of exercise-based therapy into a cognitive-behavioral approach. Assessments took place at admission, pre-intervention, post-intervention, discharge, and 6 months follow-up. Primary outcome was the severity of compulsive exercise assessed by the Commitment to Exercise Scale between pre- and post-intervention; secondary outcomes were additional aspects of compulsive exercise, assessed by the Compulsive Exercise Test, weight gain, eating disorder and general psychopathology, and emotion regulation. RESULTS In intention-to-treat analysis for the primary outcome, the TAU + HEB group showed significantly stronger reductions in the severity of compulsive exercise compared to the TAU group (z = -2.81; p = 0.005; effect size [ES] = -0.3). We also found significantly stronger reductions from admission to discharge (z= 2.62; p = 0.009; ES = -0.43), and from admission to follow-up (z = 2.1; p = 0.035; ES = -0.39). Regarding secondary outcomes, we found significant group differences between pre- and post-intervention in additional aspects of compulsive exercise (z = -2.55; p = 0.011; ES = -0.27). We did not find significant differences regarding weight gain, eating disorder and general psychopathology, and emotion regulation. CONCLUSIONS Our intervention proved efficacious in reducing compulsive exercise in inpatients with (atypical) AN.",2020,"Regarding secondary outcomes, we found significant group differences between pre- and post-intervention in additional aspects of compulsive exercise (z = -2.55; p = 0.011; ES = -0.27).","['Inpatients with Anorexia Nervosa', 'Two hundred and seven adolescent and adult female inpatients with (atypical', 'inpatients with (atypical) AN']","['TAU + HEB', 'manualized group intervention ""healthy exercise behavior"" (HEB', 'HEB', 'Compulsive Exercise', 'TAU or to additional participation in HEB (TAU + HEB', 'Specialized Group Intervention', 'compulsive exercise']","['effect size [ES', 'weight gain, eating disorder and general psychopathology, and emotion regulation', 'severity of compulsive exercise', 'additional aspects of compulsive exercise', 'severity of compulsive exercise assessed by the Commitment to Exercise Scale between pre- and post-intervention; secondary outcomes were additional aspects of compulsive exercise, assessed by the Compulsive Exercise Test, weight gain, eating disorder and general psychopathology, and emotion regulation', 'compulsive exercise']","[{'cui': 'C0021562', 'cui_str': 'Inpatient (person)'}, {'cui': 'C0003125', 'cui_str': 'Anorexia Nervosas'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0205182', 'cui_str': 'Atypical (qualifier value)'}]","[{'cui': 'C1720655', 'cui_str': 'Tau'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}]","[{'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C0043094', 'cui_str': 'Weight Gain'}, {'cui': 'C0013473', 'cui_str': 'Eating Disorders'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0033927', 'cui_str': 'Psychopathology'}, {'cui': 'C0013987', 'cui_str': 'Emotions'}, {'cui': 'C0220905', 'cui_str': 'regulations'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0222045'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0015260', 'cui_str': 'Exercise Test'}]",207.0,0.103307,"Regarding secondary outcomes, we found significant group differences between pre- and post-intervention in additional aspects of compulsive exercise (z = -2.55; p = 0.011; ES = -0.27).","[{'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Dittmer', 'Affiliation': 'Schoen Clinic Roseneck, Prien am Chiemsee, Germany, NDittmer@schoen-klinik.de.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Voderholzer', 'Affiliation': 'Schoen Clinic Roseneck, Prien am Chiemsee, Germany.'}, {'ForeName': 'Claudia', 'Initials': 'C', 'LastName': 'Mönch', 'Affiliation': 'Schoen Clinic Roseneck, Prien am Chiemsee, Germany.'}, {'ForeName': 'Ulrich', 'Initials': 'U', 'LastName': 'Cuntz', 'Affiliation': 'Schoen Clinic Roseneck, Prien am Chiemsee, Germany.'}, {'ForeName': 'Corinna', 'Initials': 'C', 'LastName': 'Jacobi', 'Affiliation': 'Department of Clinical Psychology and E-Mental-Health, Technische Universität Dresden, Dresden, Germany.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Schlegl', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University Hospital of Munich (LMU), Munich, Germany.'}]",Psychotherapy and psychosomatics,['10.1159/000504583'] 3119,31479068,"Effects of open-label placebo on pain, functional disability, and spine mobility in patients with chronic back pain: a randomized controlled trial.","Chronic back pain (CBP) is a major global health problem, while its treatment is hampered by a lack of efficacy and restricted safety profile of common frontline therapies. The present trial aims to determine whether a 3-week open-label placebo treatment reduces pain intensity and subjective and objective functional disability in patients with CBP. This randomized controlled trial, following a pretest-posttest design, enrolled 127 patients with CBP (pain duration >12 weeks) from the Back Pain Center, Neurology, University Hospital Essen, Germany. Patients randomized to the open-label placebo group received a 3-week open-label placebo treatment. Patients in the treatment as usual (TAU) group received no intervention. Both groups continued TAU. Primary outcome was the change in pain intensity. Secondary outcomes included patient-reported functional disability and objective measures of spine mobility and depression, anxiety, and stress. One hundred twenty two patients with CBP were randomized to the open-label placebo group (N = 63) or TAU group (N = 59). Open-label placebo application led to a larger reduction of pain intensity (-0.62 ± 0.23 vs 0.11 ± 0.17, all M ± SE, P = 0.001, d = -0.44) as well as patient-reported functional disability (3.21 ± 1.59 vs 0.65 ± 1.15, P = 0.020, d = -0.45) and depression scores (-1.07 ± 0.55 vs 0.37 ± 0.39, P = 0.010, d = -0.50) compared with TAU only. Open-label placebo treatment did not affect objective mobility parameters, anxiety and stress. Our study demonstrates that a 3-week open-label placebo treatment is safe, well tolerated and reduces pain, disability, and depressive symptoms in CBP. Trial registration: German Clinical Trials Register, DRKS00012712.",2019,"Open-label placebo application led to a larger reduction of pain intensity (-0.62±0.23 vs. 0.11±0.17, all M ± SE, p=.001, d=-0.44) as well as patient-reported functional disability (3.21±1.59 vs. 0.65±1.15, p=.020, d=-0.45) and depression scores (-1.07±0.55 vs. 0.37±0.39, p=.010, d=-0.50) compared to treatment as usual only.","['chronic back pain patients', '122 chronic back pain patients', 'chronic back pain', 'enrolled 127 chronic back pain patients (pain duration > 12 weeks) from the Back Pain Center, Neurology, University Hospital Essen, Germany']","['3-week open-label placebo treatment', 'Open-label placebo', 'open-label placebo', 'OLP']","['pain intensity, and subjective and objective functional disability', 'pain intensity', 'safe, well tolerated and reduces pain, disability and depressive symptoms', 'objective mobility parameters, anxiety and stress', 'change in pain intensity', 'patient-reported functional disability, objective measures of spine mobility and depression, anxiety and stress', 'functional disability', 'depression scores', 'pain, functional disability and spine mobility']","[{'cui': 'C0740418', 'cui_str': 'Chronic back pain (finding)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0004604', 'cui_str': 'Backache'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0027855', 'cui_str': 'Neurology'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0017480', 'cui_str': 'Germany'}]","[{'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0231170', 'cui_str': 'Disability (finding)'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0449580', 'cui_str': 'Mobility (attribute)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C1286140', 'cui_str': 'Measure of spine'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0037949', 'cui_str': 'Spinal Column'}]",127.0,0.298589,"Open-label placebo application led to a larger reduction of pain intensity (-0.62±0.23 vs. 0.11±0.17, all M ± SE, p=.001, d=-0.44) as well as patient-reported functional disability (3.21±1.59 vs. 0.65±1.15, p=.020, d=-0.45) and depression scores (-1.07±0.55 vs. 0.37±0.39, p=.010, d=-0.50) compared to treatment as usual only.","[{'ForeName': 'Julian', 'Initials': 'J', 'LastName': 'Kleine-Borgmann', 'Affiliation': ''}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Schmidt', 'Affiliation': ''}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Hellmann', 'Affiliation': ''}, {'ForeName': 'Ulrike', 'Initials': 'U', 'LastName': 'Bingel', 'Affiliation': ''}]",Pain,['10.1097/j.pain.0000000000001683'] 3120,32034403,Pretreatment Prevotella-to-Bacteroides ratio and salivary amylase gene copy number as prognostic markers for dietary weight loss.,"BACKGROUND The inconsistent link observed between salivary amylase gene copy number (AMY1 CN) and weight management is likely modified by diet and microbiome. OBJECTIVE Based on analysis of a previously published study, we investigated the hypothesis that interaction between diet, Prevotella-to-Bacteriodes ratio (P/B ratio), and AMY1 CN influence weight change. METHODS Sixty-two people with increased waist circumference were randomly assigned to receive an ad libitum New Nordic Diet (NND) high in dietary fiber, whole grain, intrinsic sugars, and starch or an Average Danish (Western) Diet (ADD) for 26 weeks. All foods were provided free of charge. Before subjects were randomly assigned to receive the NND or ADD diet, blood and fecal samples were collected, from which AMY1 CN and P/B ratio, respectively, were determined. Body weight change was described by using linear mixed models, including biomarker [log10(P/B ratio) and/or AMY1 CN] diet-group interactions. RESULTS Baseline means ± SDs of log10(P/B ratio) and AMY1 CN were -2.1 ± 1.8 and 6.6 ± 2.4, respectively. Baseline P/B ratio predicted a 0.99-kg/unit (95% CI: 0.40, 1.57; n = 54; P < 0.001) higher weight loss for those subjects on the NND compared with those on the ADD diet, whereas AMY1 CN was not found to predict weight loss differences between the NND and ADD groups [0.05 kg/CN (95% CI: -0.40, 0.51; n = 54; P = 0.83)]. However, among subjects with low AMY1 CN (<6.5 copies), baseline P/B ratio predicted a 2.12-kg/unit (95% CI: 1.37, 2.88; n = 30; P < 0.001) higher weight loss for the NND group than the ADD group. No such differences in weight loss were found among subjects in both groups with high AMY1 CN [-0.17 kg/unit (95% CI: -1.01, 0.66; n = 24; P = 0.68)]. CONCLUSIONS The combined use of low AMY1 CN and pretreatment P/B ratio for weight loss prediction led to highly individualized weight loss results with the introduction of more fiber, whole grain, intrinsic sugars, and starch in the diet. These preliminary observations suggest that more undigested starch reaches the colon in individuals with low AMY1 CN, and that the fate of this starch depends on the gut microbiota composition. This trial was registered at clinicaltrials.gov as NCT01195610.",2020,"No such differences in weight loss were found among subjects in both groups with high AMY1 CN [-0.17 kg/unit (95% CI: -1.01, 0.66; n = 24; P = 0.68)]. ",['Sixty-two people with increased waist circumference'],"['low AMY1 CN', 'ad libitum New Nordic Diet (NND) high in dietary fiber, whole grain, intrinsic sugars, and starch or an Average Danish (Western) Diet (ADD']","['weight loss', 'Body weight change', 'Baseline means\xa0±\xa0SDs of log10(P/B ratio) and AMY1 CN', 'weight loss differences']","[{'cui': 'C4517835', 'cui_str': '62 (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}]","[{'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0012173', 'cui_str': 'Dietary Fiber'}, {'cui': 'C4042940', 'cui_str': 'Whole Grains'}, {'cui': 'C0439674', 'cui_str': 'Intrinsic (qualifier value)'}, {'cui': 'C0038179', 'cui_str': 'Starch'}, {'cui': 'C1720086', 'cui_str': 'Add - dosing instruction fragment'}]","[{'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0005911', 'cui_str': 'Body Weight Changes'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",62.0,0.040229,"No such differences in weight loss were found among subjects in both groups with high AMY1 CN [-0.17 kg/unit (95% CI: -1.01, 0.66; n = 24; P = 0.68)]. ","[{'ForeName': 'Mads F', 'Initials': 'MF', 'LastName': 'Hjorth', 'Affiliation': 'Department of Nutrition, Exercise, and Sports, Faculty of Sciences, University of Copenhagen, Denmark.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Christensen', 'Affiliation': 'Department of Nutrition, Exercise, and Sports, Faculty of Sciences, University of Copenhagen, Denmark.'}, {'ForeName': 'Thomas M', 'Initials': 'TM', 'LastName': 'Larsen', 'Affiliation': 'Department of Nutrition, Exercise, and Sports, Faculty of Sciences, University of Copenhagen, Denmark.'}, {'ForeName': 'Henrik M', 'Initials': 'HM', 'LastName': 'Roager', 'Affiliation': 'Department of Nutrition, Exercise, and Sports, Faculty of Sciences, University of Copenhagen, Denmark.'}, {'ForeName': 'Lukasz', 'Initials': 'L', 'LastName': 'Krych', 'Affiliation': 'Food Science, Faculty of Science, University of Copenhagen, Denmark.'}, {'ForeName': 'Witold', 'Initials': 'W', 'LastName': 'Kot', 'Affiliation': 'Department of Plant and Environmental Sciences, Faculty of Science, University of Copenhagen, Denmark.'}, {'ForeName': 'Dennis S', 'Initials': 'DS', 'LastName': 'Nielsen', 'Affiliation': 'Food Science, Faculty of Science, University of Copenhagen, Denmark.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Ritz', 'Affiliation': 'Department of Nutrition, Exercise, and Sports, Faculty of Sciences, University of Copenhagen, Denmark.'}, {'ForeName': 'Arne', 'Initials': 'A', 'LastName': 'Astrup', 'Affiliation': 'Department of Nutrition, Exercise, and Sports, Faculty of Sciences, University of Copenhagen, Denmark.'}]",The American journal of clinical nutrition,['10.1093/ajcn/nqaa007'] 3121,31941354,"Survival After Intravenous Versus Intraosseous Amiodarone, Lidocaine, or Placebo in Out-of-Hospital Shock-Refractory Cardiac Arrest.","BACKGROUND Antiarrhythmic drugs have not proven to significantly improve overall survival after out-of-hospital cardiac arrest from shock-refractory ventricular fibrillation/pulseless ventricular tachycardia. How this might be influenced by the route of drug administration is not known. METHODS In this prespecified analysis of a randomized, placebo-controlled clinical trial, we compared the differences in survival to hospital discharge in adults with shock-refractory ventricular fibrillation/pulseless ventricular tachycardia out-of-hospital cardiac arrest who were randomly assigned by emergency medical services personnel to an antiarrhythmic drug versus placebo in the ALPS trial (Resuscitation Outcomes Consortium Amiodarone, Lidocaine or Placebo Study), when stratified by the intravenous versus intraosseous route of administration. RESULTS Of 3019 randomly assigned patients with a known vascular access site, 2358 received ALPS drugs intravenously and 661 patients by the intraosseous route. Intraosseous and intravenous groups differed in sex, time-to-emergency medical services arrival, and some cardiopulmonary resuscitation characteristics, but were similar in others, including time-to-intravenous/intrasosseous drug receipt. Overall hospital discharge survival was 23%. In comparison with placebo, discharge survival was significantly higher in recipients of intravenous amiodarone (adjusted risk ratio, 1.26 [95% CI, 1.06-1.50]; adjusted absolute survival difference, 5.5% [95% CI, 1.5-9.5]) and intravenous lidocaine (adjusted risk ratio, 1.21 [95% CI, 1.02-1.45]; adjusted absolute survival difference, 4.7% [95% CI, 0.7-8.8]); but not in recipients of intraosseous amiodarone (adjusted risk ratio, 0.94 [95% CI, 0.66-1.32]) or intraosseous lidocaine (adjusted risk ratio, 1.03 [95% CI, 0.74-1.44]). Survival to hospital admission also increased significantly when drugs were given intravenously but not intraosseously, and favored improved neurological outcome at discharge. There were no outcome differences between intravenous and intraosseous placebo, indicating that the access route itself did not demarcate patients with poor prognosis. The study was underpowered to assess intravenous/intraosseous drug interactions, which were not statistically significant. CONCLUSIONS We found no significant effect modification by drug administration route for amiodarone or lidocaine in comparison with placebo during out-of-hospital cardiac arrest. However, point estimates for the effects of both drugs in comparison with placebo were significantly greater for the intravenous than for the intraosseous route across virtually all outcomes and beneficial only for the intravenous route. Given that the study was underpowered to statistically assess interactions, these findings signal the potential importance of the drug administration route during resuscitation that merits further investigation.",2020,We found no significant effect modification by drug administration route for amiodarone or lidocaine compared to placebo during OHCA.,"['adults with shock-refractory VF/VT OHCA who were randomized by emergency medical services (EMS) personnel to an', '3,019 randomized patients with known vascular access site', 'and 661 patients by IO route']","['placebo', 'IO lidocaine', 'IO amiodarone', 'Amiodarone, Lidocaine or Placebo', 'IO placebo', 'ALPS drugs IV', 'Amiodarone, Lidocaine or Placebo Study (ALPS', 'lidocaine', 'antiarrhythmic drug versus placebo', 'amiodarone']","['Survival to hospital admission', 'neurological outcome', 'Survival', 'Overall hospital discharge survival', 'survival to hospital discharge', 'absolute survival difference', 'discharge survival', 'overall survival']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1869063', 'cui_str': 'Shock (SMQ)'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0013961', 'cui_str': 'Emergency medical services (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0444454', 'cui_str': 'Access (attribute)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0002598', 'cui_str': 'Amiodarone'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0003195', 'cui_str': 'Anti-Arrhythmics'}]","[{'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0184666', 'cui_str': 'Hospital admission (procedure)'}, {'cui': 'C0205494', 'cui_str': 'Neurologic (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}]",3019.0,0.479938,We found no significant effect modification by drug administration route for amiodarone or lidocaine compared to placebo during OHCA.,"[{'ForeName': 'Mohamud R', 'Initials': 'MR', 'LastName': 'Daya', 'Affiliation': 'Department of Emergency Medicine (M.R.D., J.R.L.), Oregon Health & Science University, Portland.'}, {'ForeName': 'Brian G', 'Initials': 'BG', 'LastName': 'Leroux', 'Affiliation': 'Department of Biostatistics, University of Washington Clinical Trial Center, Seattle (B.G.L.).'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Dorian', 'Affiliation': ""Division of Cardiology (P.D.), St Michael's Hospital, University of Toronto, Canada.""}, {'ForeName': 'Thomas D', 'Initials': 'TD', 'LastName': 'Rea', 'Affiliation': 'Department of Medicine (T.D.R.), University of Washington, Seattle.'}, {'ForeName': 'Craig D', 'Initials': 'CD', 'LastName': 'Newgard', 'Affiliation': 'Center for Policy and Research in Emergency Medicine, Department of Emergency Medicine (C.D.N.), Oregon Health & Science University, Portland.'}, {'ForeName': 'Laurie J', 'Initials': 'LJ', 'LastName': 'Morrison', 'Affiliation': ""Rescu, Li Ka Shing Knowledge Institute (L.J.M.), St Michael's Hospital, University of Toronto, Canada.""}, {'ForeName': 'Joshua R', 'Initials': 'JR', 'LastName': 'Lupton', 'Affiliation': 'Department of Emergency Medicine (M.R.D., J.R.L.), Oregon Health & Science University, Portland.'}, {'ForeName': 'James J', 'Initials': 'JJ', 'LastName': 'Menegazzi', 'Affiliation': 'Department of Emergency Medicine, University of Pittsburgh School of Medicine, PA (J.J.M.).'}, {'ForeName': 'Joseph P', 'Initials': 'JP', 'LastName': 'Ornato', 'Affiliation': 'Virginia Commonwealth University Health System, Richmond (J.P.O.).'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Sopko', 'Affiliation': 'National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD (G.S.).'}, {'ForeName': 'Jim', 'Initials': 'J', 'LastName': 'Christenson', 'Affiliation': 'Department of Emergency Medicine (J.C.).'}, {'ForeName': 'Ahamed', 'Initials': 'A', 'LastName': 'Idris', 'Affiliation': 'Departments of Emergency Medicine and Internal Medicine (A.I.), UT Southwestern Medical Center, Dallas, TX.'}, {'ForeName': 'Purav', 'Initials': 'P', 'LastName': 'Mody', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine (P.M.), UT Southwestern Medical Center, Dallas, TX.'}, {'ForeName': 'Gary M', 'Initials': 'GM', 'LastName': 'Vilke', 'Affiliation': 'Department of Emergency Medicine, University of California San Diego (G.M.V.).'}, {'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Herdeman', 'Affiliation': 'Department of Emergency Medicine, Medical College of Wisconsin, Milwaukee (C.H.).'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Barbic', 'Affiliation': 'University of British Columbia, Vancouver, Canada (D.B.).'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Kudenchuk', 'Affiliation': 'Department of Medicine, Division of Cardiology (P.J.K.), University of Washington, Seattle.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Circulation,['10.1161/CIRCULATIONAHA.119.042240'] 3122,32031887,"Multisite, Randomized Trial of Early Integrated Palliative and Oncology Care in Patients with Advanced Lung and Gastrointestinal Cancer: Alliance A221303.","Background: We conducted a multicenter, randomized trial of early integrated palliative and oncology care in patients with advanced cancer to confirm the benefits of early palliative care (PC) seen in prior single-center studies. Methods: We randomly assigned patients with newly diagnosed incurable cancer to early integrated palliative and oncology care ( n  = 195) or usual oncology care ( n  = 196) at sites through the Alliance for Clinical Trials in Oncology. Patients assigned to the intervention were expected to meet with a PC clinician at least monthly until death, whereas usual care patients consulted PC on request. The primary endpoint was the change in quality of life from baseline to week 12 per the Functional Assessment of Cancer Therapy-General (FACT-G). Secondary outcomes included anxiety, depression, and communication about prognosis and end-of-life care. Results: Due to significant morbidity and a high proportion of measures that were not completed within the protocol window or for unknown reasons, the rate of missing data was high. We anticipated that 70% of patients ( n  = 280) would complete the FACT-G at baseline and week 12, but only 49.3% ( n  = 193/391) completed the measure. Delivery of the intervention was also suboptimal, as 14.9% ( n  = 29/195) of intervention patients had no PC visits by week 12. Intervention patients reported a mean 3.35 (standard deviation [SD] = 14.7) increase in FACT-G scores from baseline to week 12 compared with usual care patients who reported a 0.12 (SD = 12.7) increase from baseline ( p  = 0.10). Conclusion: This study highlights the difficulties of conducting multicenter trials of supportive care interventions in patients with advanced cancer. Clinical Trials Registration: NCT02349412.",2020,"Delivery of the intervention was also suboptimal, as 14.9% ( n  = 29/195) of intervention patients had no PC visits by week 12.","['patients with advanced cancer', 'patients with newly diagnosed incurable cancer to early integrated palliative and oncology care ( n \u2009=\u2009195) or usual oncology care ( n \u2009=\u2009196) at sites through the Alliance for Clinical Trials in Oncology', 'Patients with Advanced Lung and Gastrointestinal Cancer', 'patients with advanced cancer to confirm the benefits of early palliative care (PC) seen in prior single-center studies']","['Early Integrated Palliative and Oncology Care', 'early integrated palliative and oncology care', 'supportive care interventions']","['FACT-G scores', 'Functional Assessment of Cancer Therapy-General (FACT-G', 'change in quality of life', 'anxiety, depression, and communication about prognosis and end-of-life care', 'PC visits']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C1285530', 'cui_str': 'Palliative'}, {'cui': 'C4517624', 'cui_str': '195'}, {'cui': 'C4517625', 'cui_str': '196'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0024109', 'cui_str': 'Lung'}, {'cui': 'C0685938', 'cui_str': 'Gastrointestinal Cancer'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0700049', 'cui_str': 'Palliative care'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C1285530', 'cui_str': 'Palliative'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0034380'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0033325', 'cui_str': 'Prognosis'}, {'cui': 'C0039548', 'cui_str': 'End of Life Care'}]",,0.147398,"Delivery of the intervention was also suboptimal, as 14.9% ( n  = 29/195) of intervention patients had no PC visits by week 12.","[{'ForeName': 'Jennifer S', 'Initials': 'JS', 'LastName': 'Temel', 'Affiliation': 'Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'Jeff', 'Initials': 'J', 'LastName': 'Sloan', 'Affiliation': 'Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'Tyler', 'Initials': 'T', 'LastName': 'Zemla', 'Affiliation': 'Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'Joseph A', 'Initials': 'JA', 'LastName': 'Greer', 'Affiliation': 'Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'Vicki A', 'Initials': 'VA', 'LastName': 'Jackson', 'Affiliation': 'Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'Areej', 'Initials': 'A', 'LastName': 'El-Jawahri', 'Affiliation': 'Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'Mihir', 'Initials': 'M', 'LastName': 'Kamdar', 'Affiliation': 'Massachusetts General Hospital, Boston, Massachusetts, USA.'}, {'ForeName': 'Arif', 'Initials': 'A', 'LastName': 'Kamal', 'Affiliation': 'Duke University Medical Center, Durham, North Carolina, USA.'}, {'ForeName': 'Craig D', 'Initials': 'CD', 'LastName': 'Blinderman', 'Affiliation': 'Columbia University Medical Center, New York, New York, USA.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Strand', 'Affiliation': 'Mayo Clinic, Rochester, Minnesota, USA.'}, {'ForeName': 'Dylan', 'Initials': 'D', 'LastName': 'Zylla', 'Affiliation': 'Park Nicollet/HealthPartners, Metro-Minnesota Community Oncology Research Consortium, Minneapolis, Minnesota, USA.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Daugherty', 'Affiliation': 'University of Chicago Comprehensive Cancer Center, Chicago, Illinois, USA.'}, {'ForeName': 'Muhummad', 'Initials': 'M', 'LastName': 'Furqan', 'Affiliation': 'University of Iowa Hospitals and Clinics, Iowa City, Iowa, USA.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Obel', 'Affiliation': 'NorthShore University HealthSystem CCOP, Evanston, Illinois, USA.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Razaq', 'Affiliation': 'University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, USA.'}, {'ForeName': 'Eric J', 'Initials': 'EJ', 'LastName': 'Roeland', 'Affiliation': 'University of California San Diego Moores Cancer Center, La Jolla, California, USA.'}, {'ForeName': 'Charles', 'Initials': 'C', 'LastName': 'Loprinzi', 'Affiliation': 'Mayo Clinic, Rochester, Minnesota, USA.'}]",Journal of palliative medicine,['10.1089/jpm.2019.0377'] 3123,32052026,Efficacy and Spatial Extent of Yard-Scale Control of Aedes (Stegomyia) albopictus (Diptera: Culicidae) Using Barrier Sprays and Larval Habitat Management.,"The Asian tiger mosquito, Aedes (Stegomyia) albopictus (Skuse), is a peridomestic, container-ovipositing mosquito commonly found throughout the southeastern United States. In the United States, Ae. albopictus is typically considered a nuisance pest; however, it is capable of transmitting multiple pathogens. Ae. albopictus is an important pest species and the target of numerous mosquito control efforts in the United States. Here, we evaluate the effectiveness and spatial extent of Ae. albopictus population reduction using a bifenthrin (AI Bifen IT, 7.9%) barrier spray and larval habitat management (LHM) in a temperate, suburban setting. Sixteen pairs of adjoining neighbors were randomly assigned to treatment groups with one neighbor receiving a treatment and the other monitored for evidence of a spillover effect of the treatments. Ae. albopictus populations in both yards were monitored for 33 d, with treatments occurring on the eighth day. Barrier sprays, both alone and combined with LHM, resulted in a significant reduction in Ae. albopictus abundance posttreatment. While LHM alone did not result in a significant reduction over the entire posttreatment period, Ae. albopictus populations were observed to be in decline during this period. No treatments were observed to have any reduction in efficacy 25 d posttreatment, with treatments involving LHM having a significantly increased efficacy. Yards neighboring treated yards were also observed to have reduced population sizes posttreatment, but these differences were rarely significant. These results provide insights into the population dynamics of Ae. albopictus following two common treatments and will be useful for integrated pest management plans.",2020,"albopictus population reduction using a bifenthrin (AI Bifen IT, 7.9%) barrier spray and larval habitat management (LHM) in a temperate, suburban setting.",['Sixteen pairs of adjoining neighbors'],"['bifenthrin (AI Bifen IT, 7.9%) barrier spray and larval habitat management (LHM', 'Yard-Scale Control of Aedes (Stegomyia) albopictus ', 'LHM', 'Barrier Sprays and Larval Habitat Management']",['efficacy'],"[{'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C1553702', 'cui_str': 'Neighbor (person)'}]","[{'cui': 'C0390645', 'cui_str': 'bifenthrin'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C4521772', 'cui_str': 'Spray'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0871648', 'cui_str': 'Habitat'}, {'cui': 'C0560016', 'cui_str': 'yd3'}, {'cui': 'C0222045'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]",[],,0.0261689,"albopictus population reduction using a bifenthrin (AI Bifen IT, 7.9%) barrier spray and larval habitat management (LHM) in a temperate, suburban setting.","[{'ForeName': 'Brandon', 'Initials': 'B', 'LastName': 'Hollingsworth', 'Affiliation': 'Biomathematics Graduate Program, North Carolina State University, Raleigh, NC.'}, {'ForeName': 'Pete', 'Initials': 'P', 'LastName': 'Hawkins', 'Affiliation': 'The Mosquito Authority, LLC, Morrisville, NC.'}, {'ForeName': 'Alun L', 'Initials': 'AL', 'LastName': 'Lloyd', 'Affiliation': 'Biomathematics Graduate Program, North Carolina State University, Raleigh, NC.'}, {'ForeName': 'Michael H', 'Initials': 'MH', 'LastName': 'Reiskind', 'Affiliation': 'Department of Entomology and Plant Pathology, North Carolina State University, Raleigh, NC.'}]",Journal of medical entomology,['10.1093/jme/tjaa016'] 3124,31597207,Cost-effectiveness of e-cigarettes compared with nicotine replacement therapy in stop smoking services in England (TEC study): a randomized controlled trial.,"AIM To evaluate the cost-effectiveness of e-cigarettes as a smoking cessation aid used in routine stop smoking services in England. DESIGN Cost-effectiveness analysis was performed from the National Health Service (NHS) and Personal Social Services (PSS) perspective for 12-month periods and life-time. Costs, including that of both treatments, other smoking cessation help and health-care services, and health benefits, estimated from EQ-5D-5L and measured in quality-adjusted life-years (QALYs), for the 12-month analysis, came from a randomized controlled trial. Life-time analysis was model-based with input from both trial data and published secondary data sources. Cost-effectiveness was measured by an incremental cost-effectiveness ratio (ICER). SETTING Three stop-smoking service sites in England. PARTICIPANTS Adult smokers (n = 886) who sought help to quit in the participating sites. INTERVENTION AND COMPARATOR An e-cigarette (EC) starter kit versus provision of nicotine replacement therapy (NRT) for up to 3 months, both with standard behavioural support. A total of 886 participants were randomized (439 in the EC arm, 447 in the NRT arm). Excluding one death in each arm, the 1-year quit rate was 18.0 and 9.9%, respectively. MEASUREMENTS Cost of treatments was estimated from the treatment log. Costs of other smoking cessation help and health-care services and EQ-5D-5 L were collected at baseline, 6- and 12-month follow-ups. Incremental costs and incremental QALYs were estimated using regression adjusting for baseline covariates and their respective baseline values. FINDINGS The ICER was £1100 per QALY gained at the 12 months after quit date (87% probability below £20 000/QALY). Markov model estimated the life-time ICER of EC to be £65 per QALY (85% probability below £20 000/QALY). CONCLUSION Using e-cigarettes as a smoking cessation aid with standard behavioural support in stop-smoking services in England is likely to be more cost-effective than using nicotine replacement therapy in the same setting.",2020,"The ICER was £1,100 per QALY gained at the 12 months after quit date (87% probability below £20,000/QALY).","['Three Stop-Smoking Service sites in England PARTICIPANTS: Adult smokers (n=886) who sought help to quit in the participating sites INTERVENTION AND COMPARATOR', 'routine stop smoking services in England', 'stop smoking services in England (TEC study', '886 participants were randomised (439 in EC arm, 447 in NRT arm']","['e-cigarettes', 'nicotine replacement therapy (NRT', 'nicotine replacement therapy']","['Incremental costs and incremental QALYs', 'year quit rate', 'Cost-effectiveness', 'incremental cost-effectiveness ratio (ICER', 'Cost of treatments', 'ICER']","[{'cui': 'C0450446', 'cui_str': 'Stops (attribute)'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0014282', 'cui_str': 'England'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0298247', 'cui_str': 'indium-ethylenedicysteine'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}]","[{'cui': 'C3849993', 'cui_str': 'Electronic Cigarettes'}, {'cui': 'C1278444', 'cui_str': 'Nicotine replacement therapy'}]","[{'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0080071', 'cui_str': 'QALY'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]",886.0,0.0895555,"The ICER was £1,100 per QALY gained at the 12 months after quit date (87% probability below £20,000/QALY).","[{'ForeName': 'Jinshuo', 'Initials': 'J', 'LastName': 'Li', 'Affiliation': 'Mental Health and Addiction Research Group, Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Hajek', 'Affiliation': 'Queen Mary University of London, London, UK.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Pesola', 'Affiliation': ""King's College London, London, UK.""}, {'ForeName': 'Qi', 'Initials': 'Q', 'LastName': 'Wu', 'Affiliation': 'Mental Health and Addiction Research Group, Department of Health Sciences, University of York, York, UK.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Phillips-Waller', 'Affiliation': 'Queen Mary University of London, London, UK.'}, {'ForeName': 'Dunja', 'Initials': 'D', 'LastName': 'Przulj', 'Affiliation': 'Queen Mary University of London, London, UK.'}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Myers Smith', 'Affiliation': 'Queen Mary University of London, London, UK.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Bisal', 'Affiliation': 'Queen Mary University of London, London, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Sasieni', 'Affiliation': ""King's College London, London, UK.""}, {'ForeName': 'Lynne', 'Initials': 'L', 'LastName': 'Dawkins', 'Affiliation': 'London South Bank University, London, UK.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Ross', 'Affiliation': 'Leicester City Council, Leicester, UK.'}, {'ForeName': 'Maciej Lukasz', 'Initials': 'ML', 'LastName': 'Goniewicz', 'Affiliation': 'Roswell Park Comprehensive Cancer Centre, Buffalo, NY, USA.'}, {'ForeName': 'Hayden', 'Initials': 'H', 'LastName': 'McRobbie', 'Affiliation': 'Queen Mary University of London, London, UK.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Parrott', 'Affiliation': 'Mental Health and Addiction Research Group, Department of Health Sciences, University of York, York, UK.'}]","Addiction (Abingdon, England)",['10.1111/add.14829'] 3125,29532416,The Effects of Synbiotic Supplementation on Metabolic Status in Women With Polycystic Ovary Syndrome: a Randomized Double-Blind Clinical Trial.,"Data on the effects of synbiotic supplementation on glycemic control, lipid profiles, and atherogenic index of plasma (AIP) of women with polycystic ovary syndrome (PCOS) are limited. The purpose of this study was to assess the effects of synbiotic supplementation on glycemic control and lipid profiles in women with PCOS. A prospective, randomized, double-blind, placebo-controlled trial was done at the Naghavi Hospital affiliated to Kashan University of Medical Sciences, Kashan, Iran, between April 2017 and June 2017. Sixty women with PCOS were randomized to intake synbiotic capsule containing Lactobacillus acidophilus strain T16 (IBRC-M10785), Lactobacillus casei strain T2 (IBRC-M10783), and Bifidobacterium bifidum strain T1 (IBRC-M10771) (2 × 10 9  CFU/g each) plus 800 mg inulin (n = 30) or placebo (n = 30) for 12 weeks. Fasting blood samples were taken at baseline and after the 12-week intervention to determine related variables. Compared with the placebo, synbiotic supplementation resulted in a significant reduction in serum insulin concentrations (- 2.8 ± 4.1 vs. + 1.8 ± 6.4 μIU/mL, P = 0.002) and homeostasis model of assessment-insulin resistance (- 0.7 ± 1.0 vs. + 0.4 ± 1.5, P = 0.002), and a significant elevation in the quantitative insulin sensitivity check index (+ 0.01 ± 0.01 vs. - 0.01 ± 0.03, P < 0.001). In addition, significant decreases in serum triglycerides (- 16.2 ± 31.4 vs. + 5.8 ± 23.1 mg/dL, P = 0.003), VLDL-cholesterol concentrations (- 3.3 ± 6.3 vs. + 1.1 ± 4.6 mg/dL, P = 0.003), and AIP (- 0.05 ± 0.08 vs. - 0.003 ± 0.10 mg/dL, P = 0.03) were seen following the supplementation of synbiotic compared with the placebo. Overall, we found that synbiotic supplementation to women with PCOS for 12 weeks had beneficial effects on markers of insulin resistance, triglycerides, VLDL-cholesterol concentrations, and AIP, but did not influence other lipid profiles. Trial registration: www.irct.ir: IRCT201604015623N71.",2019,"Compared with the placebo, synbiotic supplementation resulted in a significant reduction in serum insulin concentrations (- 2.8 ± 4.1 vs. + 1.8 ± 6.4 μIU/mL, P = 0.002) and homeostasis model of assessment-insulin resistance (- 0.7 ± 1.0 vs. + 0.4 ± 1.5, P = 0.002), and a significant elevation in the quantitative insulin sensitivity check index (+ 0.01 ± 0.01 vs. - 0.01 ± 0.03, P < 0.001).","['women with PCOS', 'women with polycystic ovary syndrome (PCOS', 'Sixty women with PCOS', 'Naghavi Hospital affiliated to Kashan University of Medical Sciences, Kashan, Iran, between April 2017 and June 2017', 'Women With Polycystic Ovary Syndrome']","['placebo', 'Synbiotic Supplementation', 'intake synbiotic capsule containing Lactobacillus acidophilus strain T16 (IBRC-M10785), Lactobacillus casei strain T2 (IBRC-M10783), and Bifidobacterium bifidum strain T1 (IBRC-M10771', 'placebo, synbiotic supplementation', 'synbiotic supplementation']","['serum insulin concentrations', 'VLDL-cholesterol concentrations', 'homeostasis model of assessment-insulin resistance', 'glycemic control, lipid profiles, and atherogenic index of plasma (AIP', 'quantitative insulin sensitivity check index', 'markers of insulin resistance, triglycerides, VLDL-cholesterol concentrations, and AIP', 'serum triglycerides', 'Fasting blood samples', 'Metabolic Status', 'glycemic control and lipid profiles']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0032460', 'cui_str': 'Sclerocystic Ovary Syndrome'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0205476', 'cui_str': 'Medical (qualifier value)'}, {'cui': 'C0022065', 'cui_str': 'Islamic Republic of Iran'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C2936470', 'cui_str': 'Synbiotics'}, {'cui': 'C4319574', 'cui_str': 'Capsule'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0022939', 'cui_str': 'Lactobacillus acidophilus'}, {'cui': 'C0080194', 'cui_str': 'Strains'}, {'cui': 'C0022940', 'cui_str': 'Lactobacillus casei'}, {'cui': 'C0314974', 'cui_str': 'Bifidobacterium bifidum'}]","[{'cui': 'C0428357', 'cui_str': 'Serum insulin measurement'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0023826', 'cui_str': 'Pre-beta-Lipoprotein Cholesterol'}, {'cui': 'C0019868', 'cui_str': 'Autoregulation'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0392762', 'cui_str': 'Quantitative (qualifier value)'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0542495', 'cui_str': 'Measurement of serum triglyceride level'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}]",60.0,0.641325,"Compared with the placebo, synbiotic supplementation resulted in a significant reduction in serum insulin concentrations (- 2.8 ± 4.1 vs. + 1.8 ± 6.4 μIU/mL, P = 0.002) and homeostasis model of assessment-insulin resistance (- 0.7 ± 1.0 vs. + 0.4 ± 1.5, P = 0.002), and a significant elevation in the quantitative insulin sensitivity check index (+ 0.01 ± 0.01 vs. - 0.01 ± 0.03, P < 0.001).","[{'ForeName': 'Mansooreh', 'Initials': 'M', 'LastName': 'Samimi', 'Affiliation': 'Department of Gynecology and Obstetrics, School of Medicine, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Adeleh', 'Initials': 'A', 'LastName': 'Dadkhah', 'Affiliation': 'Department of Gynecology and Obstetrics, School of Medicine, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Hamed', 'Initials': 'H', 'LastName': 'Haddad Kashani', 'Affiliation': 'Anatomical Sciences Research Center, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Tajabadi-Ebrahimi', 'Affiliation': 'Science Faculty, Islamic Azad University, Central Branch, Tehran, Iran.'}, {'ForeName': 'Elahe', 'Initials': 'E', 'LastName': 'Seyed Hosseini', 'Affiliation': 'Anatomical Sciences Research Center, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Zatollah', 'Initials': 'Z', 'LastName': 'Asemi', 'Affiliation': 'Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences, Kashan, Iran. asemi_r@yahoo.com.'}]",Probiotics and antimicrobial proteins,['10.1007/s12602-018-9405-z'] 3126,31879124,Augmented immune responses to a booster dose of oral cholera vaccine in Bangladeshi children less than 5 years of age: Revaccination after an interval of over three years of primary vaccination with a single dose of vaccine.,"We have earlier reported that a single dose of oral cholera vaccine (OCV) is protective in adults and children ≥5 years of age and sustained for 2 years. We enrolled participants (n = 240) from this study, between March-September 2017, over 3 years after receiving a primary single dose. Immune responses were measured in placebo group (Primary Immunization group: PI) and compared with those who received a single dose (Booster Immunization group: BI). The children were 4 to <5 years, 5 to <18 years and adults >18 years. Blood was collected at day 0 (before vaccination) and after receiving 1st and 2nd doses of OCV. Overall, the BI and PI groups showed vibriocidal antibody response after 1st and 2nd dose of vaccination in all age groups to V. cholerae O1 and O139. Young children in the BI group showed significantly higher vibriocidal antibody response two weeks after receiving the first dose as compared to PI group to LPS. Elevated plasma IgA responses to LPS after the first dose were observed among the BI group compared to the PI group among the young children. Mucosal antibody responses measured in fecal extracts showed similar increases as that of vibriocidal and LPS responses in the BI group. These results suggest a single boosting dose of OCV generated immune response in primed population >5 years of age who had earlier received OCV. However, young children who had received OCV earlier, boosting after a single dose, resulted in increased immune responses compared to the PI group. Further studies are needed to assess protection obtained from different strategies, especially for young children and to determine the numbers of primary and booster doses needed. In addition, more information is needed regarding the optimum interval between primary and booster doses to plan future interventions for cholera control. ClinicalTrials.gov Identifier: NCT02027207.",2020,Mucosal antibody responses measured in fecal extracts showed similar increases as that of vibriocidal and LPS responses in the BI group.,"['children were 4 to <5\xa0years, 5 to <18\xa0years and adults >18\xa0years', 'adults and children ≥5\xa0years of age and sustained for 2\xa0years', 'Bangladeshi children less than 5\xa0years of age', 'enrolled participants (n\xa0=\xa0240) from this study, between March-September 2017, over 3\xa0years after receiving a primary single dose', 'young children', 'Young children']","['placebo', 'oral cholera vaccine', 'oral cholera vaccine (OCV', 'vaccine']","['Elevated plasma IgA responses', 'vibriocidal antibody response', 'immune responses', 'Immune responses', 'Mucosal antibody responses', 'vibriocidal and LPS responses']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0443318', 'cui_str': 'Sustained (qualifier value)'}, {'cui': 'C0422784', 'cui_str': 'Bangladeshi'}, {'cui': 'C4319600', 'cui_str': '240 (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0337547', 'cui_str': 'Younger child (person)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0008359', 'cui_str': 'Cholera Vaccine'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}]","[{'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0020835', 'cui_str': 'Immunoglobulin A'}, {'cui': 'C0003261', 'cui_str': 'Antibody Response'}, {'cui': 'C0301872', 'cui_str': 'Immune response, function (observable entity)'}, {'cui': 'C0026724', 'cui_str': 'Mucosal Tissue'}]",,0.0583191,Mucosal antibody responses measured in fecal extracts showed similar increases as that of vibriocidal and LPS responses in the BI group.,"[{'ForeName': 'Fahima', 'Initials': 'F', 'LastName': 'Chowdhury', 'Affiliation': 'International Centre for Diarrhoeal Disease Research Bangladesh (icddr,b), Dhaka, Bangladesh.'}, {'ForeName': 'Taufiqur Rahman', 'Initials': 'TR', 'LastName': 'Bhuiyan', 'Affiliation': 'International Centre for Diarrhoeal Disease Research Bangladesh (icddr,b), Dhaka, Bangladesh.'}, {'ForeName': 'Afroza', 'Initials': 'A', 'LastName': 'Akter', 'Affiliation': 'International Centre for Diarrhoeal Disease Research Bangladesh (icddr,b), Dhaka, Bangladesh.'}, {'ForeName': 'Md Saruar', 'Initials': 'MS', 'LastName': 'Bhuiyan', 'Affiliation': 'International Centre for Diarrhoeal Disease Research Bangladesh (icddr,b), Dhaka, Bangladesh.'}, {'ForeName': 'Ashraful Islam', 'Initials': 'AI', 'LastName': 'Khan', 'Affiliation': 'International Centre for Diarrhoeal Disease Research Bangladesh (icddr,b), Dhaka, Bangladesh.'}, {'ForeName': 'Imam', 'Initials': 'I', 'LastName': 'Tauheed', 'Affiliation': 'International Centre for Diarrhoeal Disease Research Bangladesh (icddr,b), Dhaka, Bangladesh.'}, {'ForeName': 'Tasnuva', 'Initials': 'T', 'LastName': 'Ahmed', 'Affiliation': 'International Centre for Diarrhoeal Disease Research Bangladesh (icddr,b), Dhaka, Bangladesh.'}, {'ForeName': 'Jannatul', 'Initials': 'J', 'LastName': 'Ferdous', 'Affiliation': 'International Centre for Diarrhoeal Disease Research Bangladesh (icddr,b), Dhaka, Bangladesh.'}, {'ForeName': 'Pinki', 'Initials': 'P', 'LastName': 'Dash', 'Affiliation': 'International Centre for Diarrhoeal Disease Research Bangladesh (icddr,b), Dhaka, Bangladesh.'}, {'ForeName': 'Salima Raiyan', 'Initials': 'SR', 'LastName': 'Basher', 'Affiliation': 'International Centre for Diarrhoeal Disease Research Bangladesh (icddr,b), Dhaka, Bangladesh.'}, {'ForeName': 'Al', 'Initials': 'A', 'LastName': 'Hakim', 'Affiliation': 'International Centre for Diarrhoeal Disease Research Bangladesh (icddr,b), Dhaka, Bangladesh.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Lynch', 'Affiliation': 'International Vaccine Institute (IVI), Seoul, Republic of Korea.'}, {'ForeName': 'Jerome H', 'Initials': 'JH', 'LastName': 'Kim', 'Affiliation': 'International Vaccine Institute (IVI), Seoul, Republic of Korea.'}, {'ForeName': 'Jean-Louis', 'Initials': 'JL', 'LastName': 'Excler', 'Affiliation': 'International Vaccine Institute (IVI), Seoul, Republic of Korea.'}, {'ForeName': 'Deok Ryun', 'Initials': 'DR', 'LastName': 'Kim', 'Affiliation': 'International Vaccine Institute (IVI), Seoul, Republic of Korea.'}, {'ForeName': 'John D', 'Initials': 'JD', 'LastName': 'Clemens', 'Affiliation': 'International Centre for Diarrhoeal Disease Research Bangladesh (icddr,b), Dhaka, Bangladesh; UCLA Fielding School of Public Health, Los Angeles, CA, USA; Korea University School of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Firdausi', 'Initials': 'F', 'LastName': 'Qadri', 'Affiliation': 'International Centre for Diarrhoeal Disease Research Bangladesh (icddr,b), Dhaka, Bangladesh. Electronic address: fqadri@icddrb.org.'}]",Vaccine,['10.1016/j.vaccine.2019.12.034'] 3127,31948817,"Comparison of hepatitis B surface antibody levels induced by the pentavalent DTwP-HB-Hib versus the hexavalent DTaP-HB-Hib-IPV vaccine, administered to infants at 2, 4, 6, and 18 months of age, following monovalent hepatitis B vaccination at birth.","BACKGROUND In Thailand, the hepatitis B (HB) vaccine is administered as a tetravalent vaccine (DTwP-HB) to all infants at 2, 4, and 6 months of age, following an initial vaccination with a monovalent HB vaccine at birth. As part of ongoing vaccine evaluation, we aimed to compare the hepatitis B immunogenicity profiles of children who had received either the pentavalent (DTwP-HB-Hib) or the hexavalent (DTaP-HB-Hib-IPV) vaccine. METHODS Two groups of infants, whose mothers previously received the tetanus-diphtheria-acellular pertussis vaccine (Tdap), were randomly vaccinated with either pentavalent or hexavalent vaccine at 2, 4, 6, and 18 months of age, following monovalent HB vaccine at birth. Blood samples were obtained at birth, one-month post-primary series immunization (mo 7), pre-booster (mo 18), one-month post-booster (mo 19), and six months post-booster (mo 24). The third group of infants, whose mothers did not receive Tdap, was vaccinated with DTwP-HB-Hib (EPI pentavalent group). Levels of HBsAg, anti-HBc, and anti-HBs were evaluated by means of an automated Chemiluminescent Microparticle Immunoassay. RESULTS Anti-HBs levels of ≥10 mIU/ml were achieved in 99.2% (hexavalent group), 99.2% (pentavalent group), and 98.5% (EPI pentavalent group) of infants, after four-dose immunization (at 0, 2, 4, 6 months of age). One month after the additional dose given at 18 months of age, anti-HBs levels of ≥10 mIU/ml were observed in 100% (hexavalent group), 99.2% (pentavalent group), and 93.8% (EPI pentavalent group) of infants. At 24 months of age, higher percentages of infants achieving anti-HBs levels ≥10 mIU/ml were found in the hexavalent group (98.3%) compared to the pentavalent group (86.5%). CONCLUSIONS Both vaccines were effective in inducing anti-HBs levels of ≥10 mIU/ml, and therefore either can be used as a single formula booster at 18 months of age to simplify vaccine administration under the Expanded Program on Immunization in Thailand.",2020,"At 24 months of age, higher percentages of infants achieving anti-HBs levels ≥10 mIU","['≥10\xa0mIU', 'children who had received either the', 'Two groups of infants, whose mothers previously received the']","['pentavalent or hexavalent vaccine', 'tetanus-diphtheria-acellular pertussis vaccine (Tdap', 'pentavalent DTwP-HB-Hib versus the hexavalent DTaP-HB-Hib-IPV vaccine', 'pentavalent (DTwP-HB-Hib) or the hexavalent (DTaP-HB-Hib-IPV) vaccine']","['hepatitis B immunogenicity profiles', 'Levels of HBsAg, anti-HBc, and anti-HBs', 'anti-HBs levels']","[{'cui': 'C0439455', 'cui_str': 'mIU'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}]","[{'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0012546', 'cui_str': 'Corynebacterium diphtheriae Infection'}, {'cui': 'C0982332', 'cui_str': 'acellular pertussis vaccine, inactivated'}, {'cui': 'C0121772', 'cui_str': 'Haemophilus influenzae type b'}, {'cui': 'C0276240', 'cui_str': 'Infectious pustular vulvovaginitis (disorder)'}]","[{'cui': 'C0019163', 'cui_str': 'Hepatitis B Virus Infection'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0201477', 'cui_str': 'Hepatitis B surface antigen measurement (procedure)'}, {'cui': 'C0312631', 'cui_str': 'Antibody to hepatitis B core antigen (substance)'}, {'cui': 'C0369334', 'cui_str': 'Antibody to hepatitis B surface antigen (substance)'}]",,0.0326115,"At 24 months of age, higher percentages of infants achieving anti-HBs levels ≥10 mIU","[{'ForeName': 'Nawarat', 'Initials': 'N', 'LastName': 'Posuwan', 'Affiliation': 'Center of Excellence in Clinical Virology, Department of Pediatrics, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Nasamon', 'Initials': 'N', 'LastName': 'Wanlapakorn', 'Affiliation': 'Center of Excellence in Clinical Virology, Department of Pediatrics, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand; Division of Academic Affairs, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Sompong', 'Initials': 'S', 'LastName': 'Vongpunsawad', 'Affiliation': 'Center of Excellence in Clinical Virology, Department of Pediatrics, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Palittiya', 'Initials': 'P', 'LastName': 'Sintusek', 'Affiliation': 'Division of Gastroenterology and Hepatology, Department of Pediatrics, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand; Pediatric Liver Disease and Immunology STAR (Special Task Force for Activating Research), Department of Pediatrics, King Chulalongkorn Memorial Hospital and Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.'}, {'ForeName': 'Elke', 'Initials': 'E', 'LastName': 'Leuridan', 'Affiliation': 'Center for the Evaluation of Vaccination, Vaccine & Infectious Diseases Institute, Faculty of Medicine and Health Sciences, University of Antwerp, Universiteitsplein 1, 2610 Wilrijk, Belgium.'}, {'ForeName': 'Pierre', 'Initials': 'P', 'LastName': 'Van Damme', 'Affiliation': 'Center for the Evaluation of Vaccination, Vaccine & Infectious Diseases Institute, Faculty of Medicine and Health Sciences, University of Antwerp, Universiteitsplein 1, 2610 Wilrijk, Belgium.'}, {'ForeName': 'Yong', 'Initials': 'Y', 'LastName': 'Poovorawan', 'Affiliation': 'Center of Excellence in Clinical Virology, Department of Pediatrics, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand; The Academy of Science, The Royal Society of Thailand, Dusit, Bangkok 10300, Thailand. Electronic address: Yong.P@chula.ac.th.'}]",Vaccine,['10.1016/j.vaccine.2019.12.065'] 3128,32009701,How a Preschool Parent Intervention Produced Later Benefits: A Longitudinal Mediation Analysis.,"Preschool parent interventions may produce downstream benefits if initial intervention gains are sustained and improve later socialization experiences. This study explored associations between initial effects of the REDI (Research-based Developmentally Informed) Parent program and later benefits. A randomized trial involving 200 Head Start children (55% European-American, 26% African American, 19% Latino, 56% male, M age = 4.45 years) produced kindergarten gains in parenting and child skills. Four years later, sustained effects were evident in areas of academic performance and social-emotional competence at school and new benefits emerged at home. Initial gains in child academic and social-emotional domains mediated sustained gains within the same domains. In addition, initial gains in parent-child conversations, parent academic expectations, and child social-emotional skills mediated later reductions in parenting stress and child problems at home. Parent-focused preschool interventions may not only promote sustained improvements in child school adjustment but may also foster better family functioning over time.",2019,"Four years later, sustained effects were evident in areas of academic performance and social-emotional competence at school and new benefits emerged at home.","['200 Head Start children (55% European-American, 26% African American, 19% Latino, 56% male, M age = 4.45 years) produced kindergarten gains in parenting and child skills']",[],"['initial gains in parent-child conversations, parent academic expectations, and child social-emotional skills mediated later reductions in parenting stress and child problems', 'academic performance and social-emotional competence']","[{'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0018670', 'cui_str': 'Head'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0239307', 'cui_str': 'European (ethnic group)'}, {'cui': 'C0085756', 'cui_str': 'African American (ethnic group)'}, {'cui': 'C0086528', 'cui_str': 'Latinos'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]",[],"[{'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0679138', 'cui_str': 'Expectations'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0033213', 'cui_str': 'Problem (finding)'}, {'cui': 'C0036373', 'cui_str': 'Academic Performance'}, {'cui': 'C0086035', 'cui_str': 'Competence'}]",200.0,0.0183327,"Four years later, sustained effects were evident in areas of academic performance and social-emotional competence at school and new benefits emerged at home.","[{'ForeName': 'Karen L', 'Initials': 'KL', 'LastName': 'Bierman', 'Affiliation': 'Pennsylvania State University.'}, {'ForeName': 'Meghan E', 'Initials': 'ME', 'LastName': 'McDoniel', 'Affiliation': 'Pennsylvania State University.'}, {'ForeName': 'John E', 'Initials': 'JE', 'LastName': 'Loughlin-Presnal', 'Affiliation': 'Pennsylvania State University.'}]",Journal of applied developmental psychology,['10.1016/j.appdev.2019.101058'] 3129,32029509,Bortezomib with standard chemotherapy for children with acute myeloid leukemia does not improve treatment outcomes: a report from the Children's Oncology Group.,"New therapeutic strategies are needed for pediatric acute myeloid leukemia (AML) to reduce disease recurrence and treatment-related morbidity. The Children's Oncology Group Phase III AAML1031 trial tested whether the addition of bortezomib to standard chemotherapy improves survival in pediatric patients with newly diagnosed AML. AAML1031 randomized patients younger than 30 years of age with de novo AML to standard treatment with or without bortezomib. All patients received the identical chemotherapy backbone with either four intensive chemotherapy courses or three courses followed by allogeneic hematopoietic stem cell transplantation for high-risk patients. For those randomized to the intervention arm, bortezomib 1.3 mg/m 2 was given on days 1, 4 and 8 of each chemotherapy course. For those randomized to the control arm, bortezomib was not administered. In total, 1,097 patients were randomized to standard chemotherapy (n=542) or standard chemotherapy with bortezomib (n=555). There was no difference in remission induction rate between the bortezomib and control treatment arms (89% vs 91%, P =0.531). Bortezomib failed to improve 3-year event-free survival (44.8±4.5% vs 47.0±4.5%, P =0.236) or overall survival (63.6±4.5 vs 67.2±4.3, P =0.356) compared with the control arm. However, bortezomib was associated with significantly more peripheral neuropathy ( P =0.006) and intensive care unit admissions ( P =0.025) during the first course. The addition of bortezomib to standard chemotherapy increased toxicity but did not improve survival. These data do not support the addition of bortezomib to standard chemotherapy in children with de novo AML. (Trial registered at clinicaltrials.gov NCT01371981; https://www.cancer.gov/clinicaltrials/ NCT01371981 ).",2020,"Remission induction rate did not differ between bortezomib and control treatment arms (89% vs 91%, p=0.531).","['pediatric patients with newly diagnosed acute myeloid leukemia', '1097 patients', 'children with de novo acute myeloid leukemia', 'randomized patients younger than 30 years of age with de novo acute myeloid leukemia to standard treatment with or without', 'children with acute myeloid leukemia']","['standard chemotherapy with bortezomib', 'identical chemotherapy backbone with either four intensive chemotherapy courses or three courses followed by allogeneic hematopoietic stem cell transplantation', 'Bortezomib', 'bortezomib to standard chemotherapy', 'AAML1031', 'standard chemotherapy', 'Bortezomib with standard chemotherapy', 'bortezomib']","['three-year event-free survival', 'Remission induction rate', 'survival', 'intensive care unit admissions', 'toxicity', 'overall survival', 'peripheral neuropathy']","[{'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0023467', 'cui_str': 'Nonlymphoblastic Leukemia, Acute'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C1176309', 'cui_str': 'bortezomib'}, {'cui': 'C0205280', 'cui_str': 'Identical (qualifier value)'}, {'cui': 'C0750729', 'cui_str': 'Courses (qualifier value)'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0472699', 'cui_str': 'Hematopoietic Stem Cell Transplantation'}]","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}, {'cui': 'C0035052', 'cui_str': 'Remission Induction'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0031117', 'cui_str': 'PNS (Peripheral Nervous System) Diseases'}]",1097.0,0.199001,"Remission induction rate did not differ between bortezomib and control treatment arms (89% vs 91%, p=0.531).","[{'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Aplenc', 'Affiliation': ""The Children's Hospital of Philadelphia, Division of Oncology, Philadelphia, PA, USA aplenc@email.chop.edu.""}, {'ForeName': 'Soheil', 'Initials': 'S', 'LastName': 'Meshinchi', 'Affiliation': 'Fred Hutchinson Cancer Research Center, Seattle, WA, USA.'}, {'ForeName': 'Lillian', 'Initials': 'L', 'LastName': 'Sung', 'Affiliation': 'The Hospital for Sick Children, Toronto, ON, Canada.'}, {'ForeName': 'Todd', 'Initials': 'T', 'LastName': 'Alonzo', 'Affiliation': 'University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Choi', 'Affiliation': ""St. Jude Children's Research Hospital, Memphis, TN, USA.""}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Fisher', 'Affiliation': ""The Children's Hospital of Philadelphia, Division of Infectious Disease, Philadelphia, PA, USA.""}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Gerbing', 'Affiliation': ""Children's Oncology Group, Monrovia, CA, USA.""}, {'ForeName': 'Betsy', 'Initials': 'B', 'LastName': 'Hirsch', 'Affiliation': 'University of Minnesota, Minneapolis, MN, USA.'}, {'ForeName': 'Terzah', 'Initials': 'T', 'LastName': 'Horton', 'Affiliation': ""Texas Children's Hospital, Houston, TX, USA.""}, {'ForeName': 'Samir', 'Initials': 'S', 'LastName': 'Kahwash', 'Affiliation': ""Nationwide Children's Hospital, Columbus, OH, USA.""}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Levine', 'Affiliation': 'Mount Sinai Medical Center, New York, NY, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Loken', 'Affiliation': 'Hemaologics Inc., Seattle, WA, USA.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Brodersen', 'Affiliation': 'Hemaologics Inc., Seattle, WA, USA.'}, {'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Pollard', 'Affiliation': 'Dana Farber Cancer Center, Boston, MA, USA.'}, {'ForeName': 'Susana', 'Initials': 'S', 'LastName': 'Raimondi', 'Affiliation': ""St. Jude Children's Research Hospital, Memphis, TN, USA.""}, {'ForeName': 'Edward Anders', 'Initials': 'EA', 'LastName': 'Kolb', 'Affiliation': 'Alfred I. duPont Hospital for Children, Wilmington, DE, USA.'}, {'ForeName': 'Alan', 'Initials': 'A', 'LastName': 'Gamis', 'Affiliation': ""Children's Mercy Hospital and Clinics, Kansas City, MO, USA.""}]",Haematologica,['10.3324/haematol.2019.220962'] 3130,31235405,"Effect of a Russian-backbone live-attenuated influenza vaccine with an updated pandemic H1N1 strain on shedding and immunogenicity among children in The Gambia: an open-label, observational, phase 4 study.","BACKGROUND The efficacy and effectiveness of the pandemic H1N1 (pH1N1) component in live attenuated influenza vaccine (LAIV) is poor. The reasons for this paucity are unclear but could be due to impaired replicative fitness of pH1N1 A/California/07/2009-like (Cal09) strains. We assessed whether an updated pH1N1 strain in the Russian-backbone trivalent LAIV resulted in greater shedding and immunogenicity compared with LAIV with Cal09. METHODS We did an open-label, prospective, observational, phase 4 study in Sukuta, a periurban area in The Gambia. We enrolled children aged 24-59 months who were clinically well. Children received one dose of the WHO prequalified Russian-backbone trivalent LAIV containing either A/17/California/2009/38 (Cal09) or A/17/New York/15/5364 (NY15) based on their year of enrolment. Primary outcomes were the percentage of children with LAIV strain shedding at day 2 and day 7, haemagglutinin inhibition seroconversion, and an increase in influenza haemagglutinin-specific IgA and T-cell responses at day 21 after LAIV. This study is nested within a randomised controlled trial investigating LAIV-microbiome interactions (NCT02972957). FINDINGS Between Feb 8, 2017, and April 12, 2017, 118 children were enrolled and received one dose of the Cal09 LAIV from 2016-17. Between Jan 15, 2018, and March 28, 2018, a separate cohort of 135 children were enrolled and received one dose of the NY15 LAIV from 2017-18, of whom 126 children completed the study. Cal09 showed impaired pH1N1 nasopharyngeal shedding (16 of 118 children [14%, 95% CI 8·0-21·1] with shedding at day 2 after administration of LAIV) compared with H3N2 (54 of 118 [46%, 36·6-55·2]; p<0·0001) and influenza B (95 of 118 [81%, 72·2-87·2]; p<0·0001), along with suboptimal serum antibody (seroconversion in six of 118 [5%, 1·9-10·7]) and T-cell responses (CD4+ interferon γ-positive and/or CD4+ interleukin 2-positive responses in 45 of 111 [41%, 31·3-50·3]). After the switch to NY15, a significant increase in pH1N1 shedding was seen (80 of 126 children [63%, 95% CI 54·4-71·9]; p<0·0001 compared with Cal09), along with improvements in seroconversion (24 of 126 [19%, 13·2-26·8]; p=0·011) and influenza-specific CD4+ T-cell responses (73 of 111 [66%, 60·0-75·6; p=0·00028]). The improvement in pH1N1 seroconversion with NY15 was even greater in children who were seronegative at baseline (24 of 64 children [38%, 95% CI 26·7-49·8] vs six of 79 children with Cal09 [8%, 2·8-15·8]; p<0·0001). Persistent shedding to day 7 was independently associated with both seroconversion (odds ratio 12·69, 95% CI 4·1-43·6; p<0·0001) and CD4+ T-cell responses (odds ratio 7·83, 95% CI 2·99-23·5; p<0·0001) by multivariable logistic regression. INTERPRETATION The pH1N1 component switch that took place between 2016 and 2018 might have overcome the poor efficacy and effectiveness reported with previous LAIV formulations. LAIV effectiveness against pH1N1 should, therefore, improve in upcoming influenza seasons. Our data highlight the importance of assessing replicative fitness, in addition to antigenicity, when selecting annual LAIV components. FUNDING The Wellcome Trust.",2019,"Cal09 showed impaired pH1N1 nasopharyngeal shedding (16 of 118 children [14%, 95% CI 8·0-21·1] with shedding at day 2 after administration of LAIV) compared with H3N2 (54 of 118 [46%, 36·6-55·2]; p<0·0001) and influenza B (95 of 118 [81%, 72·2-87·2]; p<0·0001), along with suboptimal serum antibody","['enrolled children aged 24-59 months who were clinically well', 'Between Jan 15, 2018, and March 28, 2018, a separate cohort of 135 children were enrolled and received one dose of the NY15 LAIV from 2017-18, of whom 126 children completed the study', 'children in The Gambia', 'Sukuta, a periurban area in The Gambia', 'Between Feb 8, 2017, and April 12, 2017, 118 children were enrolled and received one dose of the Cal09 LAIV from 2016-17']","['pandemic H1N1 (pH1N1) component', 'WHO prequalified Russian-backbone trivalent LAIV containing either A/17/California/2009/38 (Cal09) or A/17/New York/15/5364 (NY15', 'Russian-backbone live-attenuated influenza vaccine']","['influenza haemagglutinin-specific IgA and T-cell responses', 'T-cell responses (CD4+ interferon γ-positive and/or CD4+ interleukin 2-positive responses', 'seroconversion', 'pH1N1 seroconversion', 'CD4+ T-cell responses', 'pH1N1 shedding', 'pH1N1 nasopharyngeal shedding', 'seroconversion (odds ratio', 'influenza-specific CD4+ T-cell responses', 'percentage of children with LAIV strain shedding at day 2 and day 7, haemagglutinin inhibition seroconversion']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0443299', 'cui_str': 'Separate (qualifier value)'}, {'cui': 'C4517566', 'cui_str': '135'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0016993', 'cui_str': 'Republic of the Gambia'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C4517542', 'cui_str': '118'}]","[{'cui': 'C1615608', 'cui_str': 'Pandemics'}, {'cui': 'C0580264', 'cui_str': 'H1N1'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0337816', 'cui_str': 'Russians (ethnic group)'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C3652556', 'cui_str': 'influenza, live attenuated'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}]","[{'cui': 'C0021400', 'cui_str': 'Influenza, Human'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0020835', 'cui_str': 'Immunoglobulin A'}, {'cui': 'C0039194', 'cui_str': 'Thymus-Dependent Lymphocytes'}, {'cui': 'C0021747', 'cui_str': 'Interferons'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0021756', 'cui_str': 'TCGF'}, {'cui': 'C4042908', 'cui_str': 'Seroconversion'}, {'cui': 'C0027442', 'cui_str': 'Rhinopharynx'}, {'cui': 'C0028873', 'cui_str': 'Risk Ratio'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0080194', 'cui_str': 'Strains'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}]",118.0,0.217622,"Cal09 showed impaired pH1N1 nasopharyngeal shedding (16 of 118 children [14%, 95% CI 8·0-21·1] with shedding at day 2 after administration of LAIV) compared with H3N2 (54 of 118 [46%, 36·6-55·2]; p<0·0001) and influenza B (95 of 118 [81%, 72·2-87·2]; p<0·0001), along with suboptimal serum antibody","[{'ForeName': 'Benjamin B', 'Initials': 'BB', 'LastName': 'Lindsey', 'Affiliation': 'Vaccines and Immunity Theme, Medical Research Council Unit The Gambia at the London School of Hygiene & Tropical Medicine, Banjul, The Gambia; Department of Medicine, Imperial College London, London, UK.'}, {'ForeName': 'Ya Jankey', 'Initials': 'YJ', 'LastName': 'Jagne', 'Affiliation': 'Vaccines and Immunity Theme, Medical Research Council Unit The Gambia at the London School of Hygiene & Tropical Medicine, Banjul, The Gambia.'}, {'ForeName': 'Edwin P', 'Initials': 'EP', 'LastName': 'Armitage', 'Affiliation': 'Vaccines and Immunity Theme, Medical Research Council Unit The Gambia at the London School of Hygiene & Tropical Medicine, Banjul, The Gambia.'}, {'ForeName': 'Anika', 'Initials': 'A', 'LastName': 'Singanayagam', 'Affiliation': 'Department of Medicine, Imperial College London, London, UK.'}, {'ForeName': 'Hadijatou J', 'Initials': 'HJ', 'LastName': 'Sallah', 'Affiliation': 'Vaccines and Immunity Theme, Medical Research Council Unit The Gambia at the London School of Hygiene & Tropical Medicine, Banjul, The Gambia.'}, {'ForeName': 'Sainabou', 'Initials': 'S', 'LastName': 'Drammeh', 'Affiliation': 'Vaccines and Immunity Theme, Medical Research Council Unit The Gambia at the London School of Hygiene & Tropical Medicine, Banjul, The Gambia.'}, {'ForeName': 'Elina', 'Initials': 'E', 'LastName': 'Senghore', 'Affiliation': 'Vaccines and Immunity Theme, Medical Research Council Unit The Gambia at the London School of Hygiene & Tropical Medicine, Banjul, The Gambia.'}, {'ForeName': 'Nuredin I', 'Initials': 'NI', 'LastName': 'Mohammed', 'Affiliation': 'Vaccines and Immunity Theme, Medical Research Council Unit The Gambia at the London School of Hygiene & Tropical Medicine, Banjul, The Gambia.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Jeffries', 'Affiliation': 'Vaccines and Immunity Theme, Medical Research Council Unit The Gambia at the London School of Hygiene & Tropical Medicine, Banjul, The Gambia.'}, {'ForeName': 'Katja', 'Initials': 'K', 'LastName': 'Höschler', 'Affiliation': 'Virus Reference Department, Reference Microbiology Services, Public Health England, London, UK.'}, {'ForeName': 'John S', 'Initials': 'JS', 'LastName': 'Tregoning', 'Affiliation': 'Department of Medicine, Imperial College London, London, UK.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Meijer', 'Affiliation': 'Centre for Infectious Disease Research, Diagnostics and Laboratory Surveillance, National Institute for Public Health and the Environment, Bilthoven, Netherlands.'}, {'ForeName': 'Ed', 'Initials': 'E', 'LastName': 'Clarke', 'Affiliation': 'Vaccines and Immunity Theme, Medical Research Council Unit The Gambia at the London School of Hygiene & Tropical Medicine, Banjul, The Gambia.'}, {'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Dong', 'Affiliation': 'Medical Research Council Human Immunology Unit, Weatherall Institute of Molecular Medicine, and Chinese Academy of Medical Science-Oxford Institute, Nuffield Department of Medicine, Oxford University, Oxford, UK.'}, {'ForeName': 'Wendy', 'Initials': 'W', 'LastName': 'Barclay', 'Affiliation': 'Department of Medicine, Imperial College London, London, UK.'}, {'ForeName': 'Beate', 'Initials': 'B', 'LastName': 'Kampmann', 'Affiliation': 'Vaccines and Immunity Theme, Medical Research Council Unit The Gambia at the London School of Hygiene & Tropical Medicine, Banjul, The Gambia; The Vaccine Centre, London School of Hygiene & Tropical Medicine, Faculty of Infectious and Tropical Diseases, London, UK.'}, {'ForeName': 'Thushan I', 'Initials': 'TI', 'LastName': 'de Silva', 'Affiliation': 'Vaccines and Immunity Theme, Medical Research Council Unit The Gambia at the London School of Hygiene & Tropical Medicine, Banjul, The Gambia; Department of Medicine, Imperial College London, London, UK; The Florey Institute for Host-Pathogen Interactions and Department of Infection, Immunity and Cardiovascular Disease, University of Sheffield, Sheffield, UK. Electronic address: tdesilva@mrc.gm.'}]",The Lancet. Respiratory medicine,['10.1016/S2213-2600(19)30086-4'] 3131,32030734,The impact of fluid optimisation before induction of anaesthesia on hypotension after induction.,"Intra-operative hypotension is a known predictor of adverse events and poor outcomes following major surgery. Hypotension often occurs on induction of anaesthesia, typically attributed to hypovolaemia and the haemodynamic effects of anaesthetic agents. We assessed the efficacy of fluid optimisation for reducing the incidence of hypotension on induction of anaesthesia. This prospective trial enrolled 283 patients undergoing radical cystectomy and randomly allocated them to goal-directed fluid therapy (n = 142) or standard fluid therapy (n = 141). Goal-directed fluid therapy patients received fluid optimisation based on stroke volume response to passive leg raise before induction; those with positive passive leg raise received intravenous crystalloid fluid boluses until stroke volume was optimised. Baseline mean arterial pressure was measured on the morning of surgery and on arriving in the operating theatre. This post-hoc analysis defined haemodynamic instability as either a > 30% relative drop in mean arterial pressure compared with baseline or absolute mean arterial pressure < 55 mmHg, within 15 min of induction. Forty-two (30%) goal-directed fluid therapy patients underwent fluid optimisation after finding an intravascular fluid deficit via passive leg raise testing; 106 (75%) goal-directed fluid therapy and 112 (79%) standard fluid therapy patients met criteria for haemodynamic instability. There was no significant difference in the incidence of haemodynamic instability between the goal-directed fluid therapy and standard fluid therapy groups using absolute mean arterial pressure drop below 55 mmHg (p = 0.58) or using pre-surgical testing or pre-surgical mean arterial pressure values as baseline (p = 0.21, p = 0.89, respectively); however, the difference in the incidence of haemodynamic instability was significant using the operating theatre baseline mean arterial pressure (p = 0.004). We conclude that fluid optimisation before induction of general anaesthesia did not significantly impact haemodynamic instability.",2020,There was no significant difference in the incidence of haemodynamic instability between the goal-directed fluid therapy and standard fluid therapy groups using absolute mean arterial pressure drop below 55 mmHg (p = 0.58) or using pre-surgical testing or pre-surgical mean arterial pressure values as baseline (,"['283 patients undergoing', 'patients met criteria for haemodynamic instability']","['goal-directed fluid therapy (n\xa0=\xa0142) or standard fluid therapy', 'radical cystectomy', 'standard fluid therapy']","['haemodynamic instability', 'Baseline mean arterial pressure', 'operating theatre baseline mean arterial pressure', 'mean arterial pressure']","[{'cui': 'C4708786', 'cui_str': 'Two hundred and eighty-three'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0948268', 'cui_str': 'Hemodynamic instability'}]","[{'cui': 'C0018017', 'cui_str': 'Goals'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C0016286', 'cui_str': 'Fluid Therapy'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0194401', 'cui_str': 'Total resection of urinary bladder (procedure)'}]","[{'cui': 'C0948268', 'cui_str': 'Hemodynamic instability'}, {'cui': 'C0428886', 'cui_str': 'Mean Arterial Pressure'}, {'cui': 'C0029064', 'cui_str': 'Operating Room'}]",283.0,0.125273,There was no significant difference in the incidence of haemodynamic instability between the goal-directed fluid therapy and standard fluid therapy groups using absolute mean arterial pressure drop below 55 mmHg (p = 0.58) or using pre-surgical testing or pre-surgical mean arterial pressure values as baseline (,"[{'ForeName': 'A I', 'Initials': 'AI', 'LastName': 'Khan', 'Affiliation': 'Weill Cornell Medical College, New York, NY, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Fischer', 'Affiliation': 'Department of Anaesthesiology and Critical Care Medicine, Memorial Sloan Kettering Cancer Centre, New York, NY, USA.'}, {'ForeName': 'A C', 'Initials': 'AC', 'LastName': 'Pedoto', 'Affiliation': 'Department of Anaesthesiology and Critical Care Medicine, Memorial Sloan Kettering Cancer Centre, New York, NY, USA.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Seier', 'Affiliation': 'Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Centre, New York, NY, USA.'}, {'ForeName': 'K S', 'Initials': 'KS', 'LastName': 'Tan', 'Affiliation': 'Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Centre, New York, NY, USA.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Dalbagni', 'Affiliation': 'Department of Surgery, Urology Service, Memorial Sloan Kettering Cancer Centre, New York, NY, USA.'}, {'ForeName': 'S M', 'Initials': 'SM', 'LastName': 'Donat', 'Affiliation': 'Department of Surgery, Urology Service, Memorial Sloan Kettering Cancer Centre, New York, NY, USA.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Arslan-Carlon', 'Affiliation': 'Department of Anaesthesiology and Critical Care Medicine, Memorial Sloan Kettering Cancer Centre, New York, NY, USA.'}]",Anaesthesia,['10.1111/anae.14984'] 3132,32029429,Cervical versus endometrial injection for sentinel lymph node detection in endometrial cancer: a randomized clinical trial.,"OBJECTIVE To evaluate the relationship between pelvic/para-aortic sentinel lymph node status and two different injection sites of 99m-technetium ( 99m Tc)-labeled phytate in patients with endometrial cancer. METHODS This was a randomized controlled trial involving 81 patients with endometrial cancer. In the cervical group (n=40), injections of 99m Tc were performed at the 3 and 9 o'clock positions of the uterine cervix. In the endometrial group (n=41), 99m Tc was injected into the fundal endometrium using a transcervical catheter. Sentinel lymph nodes were detected through pre-operative lymphoscintigraphy and intra-operatively using a handheld gamma probe. All patients underwent complete pelvic and para-aortic lymphadenectomy procedures. Pathologic ultra-staging was performed with immunostaining for cytokeratin in sentinel lymph nodes after routine hematoxylin and eosin histological examinations. The primary endpoint was the estimation of detection rates, sensitivity, false-negative rates, negative predictive value, and analysis of the distribution of pelvic and para-aortic sentinel lymph nodes. RESULTS The rate of detection of at least one sentinel lymph node, sensitivity, and the negative predictive value was 80%, 66.6%, 96.6% for the cervical group and 85%, 66.6%, 96.9% for the endometrial group, respectively. False-negative sentinel lymph nodes were detected in one patient from each group . There was no significant difference between the groups in terms of total sentinel lymph node count, sentinel pelvic lymph node count, and pelvic bilaterality, but the para-aortic sentinel lymph node count was significantly higher in the endometrial group (p<0.001). Ultra-staging examination of the pelvic sentinel lymph nodes revealed isolated tumor cells in one patient from each group. CONCLUSION Transcervical endometrial tracer injection in endometrial cancer revealed similar pelvic but significantly higher para-aortic sentinel lymph node detection.",2020,"There was no significant difference between the groups in terms of total sentinel lymph node count, sentinel pelvic lymph node count, and pelvic bilaterality, but the para-aortic sentinel lymph node count was significantly higher in the endometrial group (p<0.001).","['endometrial cancer', 'All patients underwent complete pelvic and para-aortic lymphadenectomy procedures', '81 patients with endometrial cancer', 'patients with endometrial cancer']","['Transcervical endometrial tracer injection', '99m-technetium', 'Cervical versus endometrial injection']","['rate of detection of at least one sentinel lymph node, sensitivity, and the negative predictive value', 'estimation of detection rates, sensitivity, false-negative rates, negative predictive value, and analysis of the distribution of pelvic and para-aortic sentinel lymph nodes', 'False-negative sentinel lymph nodes', 'total sentinel lymph node count, sentinel pelvic lymph node count, and pelvic bilaterality, but the para-aortic sentinel lymph node count']","[{'cui': 'C0476089', 'cui_str': 'Endometrial Carcinoma'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0030797', 'cui_str': 'Pelvic Region'}, {'cui': 'C0442134', 'cui_str': 'Peri-aortic'}, {'cui': 'C0024203', 'cui_str': 'Lymphadenectomy'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}]","[{'cui': 'C0442344', 'cui_str': 'Transcervical approach - uterine (qualifier value)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0039411', 'cui_str': 'Technetium'}, {'cui': 'C0205064', 'cui_str': 'Cervical (qualifier value)'}]","[{'cui': 'C1522495', 'cui_str': 'Sentinal Node'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0205558', 'cui_str': 'False negative (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0037775', 'cui_str': 'Distributions (qualifier value)'}, {'cui': 'C0030797', 'cui_str': 'Pelvic Region'}, {'cui': 'C0442134', 'cui_str': 'Peri-aortic'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C0729595', 'cui_str': 'Pelvic lymph node structure (body structure)'}]",81.0,0.0473042,"There was no significant difference between the groups in terms of total sentinel lymph node count, sentinel pelvic lymph node count, and pelvic bilaterality, but the para-aortic sentinel lymph node count was significantly higher in the endometrial group (p<0.001).","[{'ForeName': 'Şener', 'Initials': 'Ş', 'LastName': 'Gezer', 'Affiliation': 'Department of Obstetrics and Gynecology, Kocaeli University School of Medicine, Kocaeli, Turkey dr.senergezer@gmail.com.'}, {'ForeName': 'Seda', 'Initials': 'S', 'LastName': 'Duman Öztürk', 'Affiliation': 'Department of Pathology, Kocaeli University School of Medicine, Kocaeli, Turkey.'}, {'ForeName': 'Turkay', 'Initials': 'T', 'LastName': 'Hekimsoy', 'Affiliation': 'Department of Nuclear Medicine, Kocaeli University School of Medicine, Kocaeli, Turkey.'}, {'ForeName': 'Çiğdem', 'Initials': 'Ç', 'LastName': 'Vural', 'Affiliation': 'Department of Pathology, Kocaeli University School of Medicine, Kocaeli, Turkey.'}, {'ForeName': 'Serkan', 'Initials': 'S', 'LastName': 'İşgören', 'Affiliation': 'Department of Nuclear Medicine, Kocaeli University School of Medicine, Kocaeli, Turkey.'}, {'ForeName': 'İzzet', 'Initials': 'İ', 'LastName': 'Yücesoy', 'Affiliation': 'Department of Obstetrics and Gynecology, Kocaeli University School of Medicine, Kocaeli, Turkey.'}, {'ForeName': 'Aydın', 'Initials': 'A', 'LastName': 'Çorakçı', 'Affiliation': 'Department of Obstetrics and Gynecology, Kocaeli University School of Medicine, Kocaeli, Turkey.'}]",International journal of gynecological cancer : official journal of the International Gynecological Cancer Society,['10.1136/ijgc-2019-000860'] 3133,32029439,Randomized Trial of Intermediate-dose Cytarabine in Induction and Consolidation Therapy in Adults with Acute Myeloid Leukemia.,"PURPOSE Cytarabine, 100-200 mg/mE+2/day, is commonly used in induction therapy of acute myelogenous leukemia (AML). Whether a higher dose of cytarabine would be more effective is unknown. Also, there is controversy whether high-dose cytarabine is better than an intermediate-dose combined with other drugs for post-remission therapy. In this open-label, randomized controlled, parallel group study, roles of intermediate-dose cytarabine were investigated. PATIENTS AND METHODS Subjects with AML age 15-55 years were randomized to receive daunorubicin, omacetaxine mepesuccinate, and conventional- or intermediate-dose cytarabine. Subjects achieving complete remission were randomized to receive 3 courses of high-dose cytarabine or 2 courses of intermediate-dose cytarabine with daunorubicin in the 1 st and mitoxantrone in the 2 nd course. The primary endpoint was disease-free survival (DFS). RESULTS 591 subjects were randomized to intermediate- ( N = 295) or conventional-dose ( N = 296) cytarabine group. Three-year DFSs were 67% [95% confidence interval (CI), 61-73] in the intermediate-dose cohort compared with 54% (95% CI, 48-61) in the conventional-dose cohort [Hazard Ratio (HR), 0.67; 95%CI, 0.51-0.89; P = 0.005). Three-year survivals were 68% (95%CI, 63-74) and 59% (95%CI, 53-65; HR, 0.720; 95%CI, 0.56-0.94; P = 0.014). Two courses of intermediate-dose cytarabine with daunorubicin or mitoxantrone resulted in similar DFS and survival as three courses of high-dose cytarabine when used for post-remission therapy. CONCLUSIONS Induction therapy with intermediate-dose cytarabine with daunorubicin and omacetaxine mepesuccinate increases DFS and survival in persons with AML ages 15-55 years compared with conventional-dose cytarabine. See related commentary by Watts and Bradley, p. 3073 .",2020,"Three-year DFSs were 67% (95% confidence interval [CI], 61-73) in the intermediate-dose cohort compared with 54% (95%CI, 48-61) in the conventional-dose cohort (Hazard Ratio [","['Subjects achieving complete remission', 'Subjects with AML age 15-55 years', '591 subjects were randomized to intermediate', 'acute myeloid leukaemia (AML', 'persons with AML age 15-55 years', 'adults with acute myeloid leukaemia']","['cytarabine with daunorubicin or mitoxantrone', 'intermediate-dose cytarabine', 'daunorubicin, omacetaxine mepesuccinate and conventional- or intermediate-dose cytarabine', 'cytarabine with daunorubicin and omacetaxine mepesuccinate', 'cytarabine with daunorubicin', 'cytarabine', 'conventional-dose (N=296) cytarabine', 'Cytarabine', 'conventional-dose cytarabine', 'mitoxantrone']","['disease-free survival (DFS', 'year survivals', 'similar DFS and survival', 'DFS and survival']","[{'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0023467', 'cui_str': 'Nonlymphoblastic Leukemia, Acute'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0010711', 'cui_str': 'Cytarabine'}, {'cui': 'C0011015', 'cui_str': 'Daunorubicin'}, {'cui': 'C0026259', 'cui_str': 'Mitoxantrone'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0062941', 'cui_str': 'omacetaxine mepesuccinate'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}]","[{'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",591.0,0.131977,"Three-year DFSs were 67% (95% confidence interval [CI], 61-73) in the intermediate-dose cohort compared with 54% (95%CI, 48-61) in the conventional-dose cohort (Hazard Ratio [","[{'ForeName': 'Hui', 'Initials': 'H', 'LastName': 'Wei', 'Affiliation': 'State Key Laboratory of Experimental Hematology, Tianjin, China.'}, {'ForeName': 'Ying', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'National Clinical Research Center for Blood Disease, Tianjin, China.'}, {'ForeName': 'Robert Peter', 'Initials': 'RP', 'LastName': 'Gale', 'Affiliation': 'Division of Experimental Medicine, Department of Medicine, Hematology Research Center, Imperial College London, London, United Kingdom.'}, {'ForeName': 'Dong', 'Initials': 'D', 'LastName': 'Lin', 'Affiliation': 'Leukemia Center, Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences, Tianjin, China.'}, {'ForeName': 'Chunlin', 'Initials': 'C', 'LastName': 'Zhou', 'Affiliation': 'Leukemia Center, Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences, Tianjin, China.'}, {'ForeName': 'Bingcheng', 'Initials': 'B', 'LastName': 'Liu', 'Affiliation': 'Leukemia Center, Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences, Tianjin, China.'}, {'ForeName': 'Shaowei', 'Initials': 'S', 'LastName': 'Qiu', 'Affiliation': 'Leukemia Center, Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences, Tianjin, China.'}, {'ForeName': 'Runxia', 'Initials': 'R', 'LastName': 'Gu', 'Affiliation': 'Leukemia Center, Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences, Tianjin, China.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Li', 'Affiliation': 'Leukemia Center, Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences, Tianjin, China.'}, {'ForeName': 'Xingli', 'Initials': 'X', 'LastName': 'Zhao', 'Affiliation': 'Leukemia Center, Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences, Tianjin, China.'}, {'ForeName': 'Shuning', 'Initials': 'S', 'LastName': 'Wei', 'Affiliation': 'Leukemia Center, Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences, Tianjin, China.'}, {'ForeName': 'Benfa', 'Initials': 'B', 'LastName': 'Gong', 'Affiliation': 'Leukemia Center, Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences, Tianjin, China.'}, {'ForeName': 'Kaiqi', 'Initials': 'K', 'LastName': 'Liu', 'Affiliation': 'Leukemia Center, Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences, Tianjin, China.'}, {'ForeName': 'Xiaoyuan', 'Initials': 'X', 'LastName': 'Gong', 'Affiliation': 'Leukemia Center, Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences, Tianjin, China.'}, {'ForeName': 'Yuntao', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'Leukemia Center, Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences, Tianjin, China.'}, {'ForeName': 'Guangji', 'Initials': 'G', 'LastName': 'Zhang', 'Affiliation': 'Leukemia Center, Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences, Tianjin, China.'}, {'ForeName': 'Zhen', 'Initials': 'Z', 'LastName': 'Song', 'Affiliation': 'National Clinical Research Center for Blood Disease, Tianjin, China.'}, {'ForeName': 'Yang', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Peking Union Medical College and Chinese Academy of Medical Sciences, Tianjin, China.'}, {'ForeName': 'Wei', 'Initials': 'W', 'LastName': 'Li', 'Affiliation': 'State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Peking Union Medical College and Chinese Academy of Medical Sciences, Tianjin, China.'}, {'ForeName': 'Yingchang', 'Initials': 'Y', 'LastName': 'Mi', 'Affiliation': 'State Key Laboratory of Experimental Hematology, Tianjin, China. wangjx@ihcams.ac.cn ychmi@ihcams.ac.cn.'}, {'ForeName': 'Jianxiang', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': 'State Key Laboratory of Experimental Hematology, Tianjin, China. wangjx@ihcams.ac.cn ychmi@ihcams.ac.cn.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-19-3433'] 3134,26903039,Sex-Specific Differences at Presentation and Outcomes Among Patients Undergoing Transcatheter Aortic Valve Replacement: A Cohort Study.,"BACKGROUND Female sex is associated with poorer outcomes after surgical aortic valve replacement (SAVR). Data on sex-specific differences after transcatheter aortic valve replacement (TAVR) are conflicting. OBJECTIVE To examine sex-specific differences in patients undergoing TAVR in the PARTNER (Placement of Aortic Transcatheter Valves) trial. DESIGN Secondary analysis of the randomized and nonrandomized portions of the PARTNER trial. (ClinicalTrials.gov: NCT00530894). SETTING 25 hospitals in the United States, Canada, and Germany. PATIENTS High-risk and inoperable patients (1220 women and 1339 men). INTERVENTION TAVR. MEASUREMENTS Demographic characteristics, cardiac and noncardiac comorbidities, mortality, stroke, rehospitalization, vascular complications, bleeding complications, and echocardiographic valve parameters. RESULTS At baseline, women had lower rates of hyperlipidemia, diabetes, smoking, and renal disease but higher Society of Thoracic Surgeons Predicted Risk of Mortality scores (11.9% vs. 11.1%; P < 0.001). After TAVR, women had more vascular complications (17.3% vs. 10.0%; difference, 7.29 percentage points [95% CI, 4.63 to 9.95 percentage points]; P < 0.001) and major bleeding (10.5% vs. 7.7%; difference, 2.8 percentage points [CI, 0.57 to 5.04 percentage points]; P = 0.012) but less frequent moderate and severe paravalvular regurgitation (6.0% vs. 14.3%; difference, -8.3 percentage points [CI, -11.7 to -5.0 percentage points]; P < 0.001). At 30 days, the unadjusted all-cause mortality rate (6.5% vs. 5.9%; difference, 0.6 percentage point [CI, -1.29 to 2.45 percentage points]; P = 0.52) and stroke incidence (3.8% vs. 3.0%; difference, 0.8 percentage point [CI, -0.62 to 2.19 percentage points]; P = 0.28) were similar. At 1 year, all-cause mortality was significantly lower in women than in men (19.0% vs. 25.9%; hazard ratio, 0.72 [CI, 0.61 to 0.85]; P < 0.001). LIMITATION Secondary analysis that included nonrandomized trial data. CONCLUSION Despite a higher incidence of vascular and bleeding complications, women having TAVR had lower mortality than men at 1 year. Thus, sex-specific risk in TAVR is the opposite of that in SAVR, for which female sex has been shown to be independently associated with an adverse prognosis. PRIMARY FUNDING SOURCE Edwards Lifesciences.",2016,"After TAVR, women had more vascular complications (17.3% vs. 10.0%; difference, 7.29 percentage points [95% CI, 4.63 to 9.95 percentage points]; P < 0.001) and major bleeding (10.5% vs. 7.7%; difference, 2.8 percentage points [CI, 0.57 to 5.04 percentage points]; P = 0.012) but less frequent moderate and severe paravalvular regurgitation (6.0% vs. 14.3%; difference, -8.3 percentage points [CI, -11.7 to -5.0 percentage points]; P < 0.001).","['patients undergoing TAVR in the PARTNER ', 'High-risk and inoperable patients (1220 women and 1339 men', '25 hospitals in the United States, Canada, and Germany', 'Patients Undergoing Transcatheter Aortic Valve Replacement']","['surgical aortic valve replacement (SAVR', 'transcatheter aortic valve replacement (TAVR']","['rates of hyperlipidemia, diabetes, smoking, and renal disease', 'Risk of Mortality scores', 'stroke incidence', 'mortality rate', 'lower mortality', 'cause mortality', 'Demographic characteristics, cardiac and noncardiac comorbidities, mortality, stroke, rehospitalization, vascular complications, bleeding complications, and echocardiographic valve parameters', 'major bleeding', 'vascular complications', 'severe paravalvular regurgitation']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0682323', 'cui_str': 'Companion'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0205187', 'cui_str': 'Inoperable (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0006823', 'cui_str': 'Canada'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C2711836', 'cui_str': 'TAVR - Transcatheter aortic valve replacement'}]","[{'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0003506', 'cui_str': 'Replacement of aortic valve (procedure)'}, {'cui': 'C2711836', 'cui_str': 'TAVR - Transcatheter aortic valve replacement'}]","[{'cui': 'C0020473', 'cui_str': 'Hyperlipemia'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0022658', 'cui_str': 'Kidney Diseases'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0205848', 'cui_str': 'Death Rate'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0011298', 'cui_str': 'Demographics'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C3888056', 'cui_str': 'Valve (physical object)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0460152', 'cui_str': 'Regurgitation - mechanism (qualifier value)'}]",,0.457295,"After TAVR, women had more vascular complications (17.3% vs. 10.0%; difference, 7.29 percentage points [95% CI, 4.63 to 9.95 percentage points]; P < 0.001) and major bleeding (10.5% vs. 7.7%; difference, 2.8 percentage points [CI, 0.57 to 5.04 percentage points]; P = 0.012) but less frequent moderate and severe paravalvular regurgitation (6.0% vs. 14.3%; difference, -8.3 percentage points [CI, -11.7 to -5.0 percentage points]; P < 0.001).","[{'ForeName': 'Susheel', 'Initials': 'S', 'LastName': 'Kodali', 'Affiliation': ''}, {'ForeName': 'Mathew R', 'Initials': 'MR', 'LastName': 'Williams', 'Affiliation': ''}, {'ForeName': 'Darshan', 'Initials': 'D', 'LastName': 'Doshi', 'Affiliation': ''}, {'ForeName': 'Rebecca T', 'Initials': 'RT', 'LastName': 'Hahn', 'Affiliation': ''}, {'ForeName': 'Karin H', 'Initials': 'KH', 'LastName': 'Humphries', 'Affiliation': ''}, {'ForeName': 'Vuyisile T', 'Initials': 'VT', 'LastName': 'Nkomo', 'Affiliation': ''}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Cohen', 'Affiliation': ''}, {'ForeName': 'Pamela S', 'Initials': 'PS', 'LastName': 'Douglas', 'Affiliation': ''}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Mack', 'Affiliation': ''}, {'ForeName': 'Ke', 'Initials': 'K', 'LastName': 'Xu', 'Affiliation': ''}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Svensson', 'Affiliation': ''}, {'ForeName': 'Vinod H', 'Initials': 'VH', 'LastName': 'Thourani', 'Affiliation': ''}, {'ForeName': 'E Murat', 'Initials': 'EM', 'LastName': 'Tuzcu', 'Affiliation': ''}, {'ForeName': 'Neil J', 'Initials': 'NJ', 'LastName': 'Weissman', 'Affiliation': ''}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Leon', 'Affiliation': ''}, {'ForeName': 'Ajay J', 'Initials': 'AJ', 'LastName': 'Kirtane', 'Affiliation': ''}]",Annals of internal medicine,['10.7326/M15-0121'] 3135,31648928,The impact of a depression self-management intervention on seizure activity.,"PURPOSE Seizures have a variety of significant physical, cognitive, and social effects upon the individual. Depression has been linked to an increase in seizure activity, and Project Using Practice and Learning to Increase Favorable Thoughts (UPLIFT) was shown to reduce depressive symptoms. Project UPLIFT, based upon mindfulness-based cognitive therapy (MBCT), provides distance delivery of depression management skills to groups of people with epilepsy. Because Project UPLIFT reduces depression and depression is linked to seizure activity, the current analysis was designed to determine the impact of Project UPLIFT upon seizure frequency and severity. METHOD Participants (n = 107) were adults ages 21-70 with epilepsy and mild-to-moderate depressive symptoms from the states of Georgia, Michigan, Texas, and Washington. The eight-session Project UPLIFT intervention was group-delivered weekly via the web or telephone. Participants were randomly assigned to condition (i.e., Project UPLIFT or a treatment-as-usual [TAU] waitlist) and assessed at baseline, and after intervening in the Project UPLIFT group (~10 weeks). Assessments included valid self-report measures of seizure frequency and severity and depression. RESULTS Mediation analysis found that there was a significant negative direct relationship between condition and number of seizures at posttest; the mean number of seizures decreased by 3.2 in the Project UPLIFT group, but increased by 2.3 in the TAU group. The indirect path from condition to number of seizures through change in depression was not significant. Conversely, there was no significant negative direct relationship between condition and seizure severity at posttest, although the seizure severity decreased by 2.2 points in the UPLIFT group and increased by 2.7 points in the TAU group. The indirect path from condition to seizure severity through depression was significant, however, demonstrating that change in depression mediated the effect of Project UPLIFT on seizure severity. CONCLUSIONS This study found that participating in Project UPLIFT directly reduced the number of seizures experienced by participants with epilepsy. This was not mediated by the change in depression. Participation in Project UPLIFT also reduced their perceived seizure severity indirectly, through reducing their depressive symptoms. This suggests Project UPLIFT may have the potential to impact the health, healthcare costs, and well-being of people with epilepsy.",2020,"Project UPLIFT, based upon mindfulness-based cognitive therapy (MBCT), provides distance delivery of depression management skills to groups of people with epilepsy.","['Participants (n\u202f=\u202f107) were adults ages 21-70 with epilepsy and mild-to-moderate depressive symptoms from the states of Georgia, Michigan, Texas, and Washington', 'people with epilepsy']","['Project UPLIFT, based upon mindfulness-based cognitive therapy (MBCT', 'depression self-management intervention', 'UPLIFT']","['seizure activity', 'number of seizures', 'valid self-report measures of seizure frequency and severity and depression', 'mean number of seizures', 'seizure severity']","[{'cui': 'C4517529', 'cui_str': 'One hundred and seven'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0014544', 'cui_str': 'Seizure Disorder'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0017454', 'cui_str': 'Georgian S.S.R.'}, {'cui': 'C0025939', 'cui_str': 'Michigan'}, {'cui': 'C0039711', 'cui_str': 'Texas'}, {'cui': 'C0043038', 'cui_str': 'Washington'}]","[{'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0086969', 'cui_str': 'Self-Management'}]","[{'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C1285627', 'cui_str': 'Measure of seizure'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}]",,0.0400273,"Project UPLIFT, based upon mindfulness-based cognitive therapy (MBCT), provides distance delivery of depression management skills to groups of people with epilepsy.","[{'ForeName': 'Nancy J', 'Initials': 'NJ', 'LastName': 'Thompson', 'Affiliation': 'Emory University, Atlanta, GA 30322, United States of America. Electronic address: nthomps@emory.edu.'}, {'ForeName': 'Robin E', 'Initials': 'RE', 'LastName': 'McGee', 'Affiliation': 'Emory University, Atlanta, GA 30322, United States of America.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Garcia-Williams', 'Affiliation': 'Emory University, Atlanta, GA 30322, United States of America.'}, {'ForeName': 'Linda M', 'Initials': 'LM', 'LastName': 'Selwa', 'Affiliation': 'University of Michigan, Ann Arbor, MI 48109, United States of America.'}, {'ForeName': 'Shelley C', 'Initials': 'SC', 'LastName': 'Stoll', 'Affiliation': 'University of Michigan, Ann Arbor, MI 48109, United States of America.'}, {'ForeName': 'Erica K', 'Initials': 'EK', 'LastName': 'Johnson', 'Affiliation': 'University of Washington, Seattle, WA 98195, United States of America.'}, {'ForeName': 'Robert T', 'Initials': 'RT', 'LastName': 'Fraser', 'Affiliation': 'University of Washington, Seattle, WA 98195, United States of America.'}]",Epilepsy & behavior : E&B,['10.1016/j.yebeh.2019.106504'] 3136,31857217,C-reactive protein and response to lurasidone treatment in children and adolescents with bipolar I depression: Results from a placebo-controlled trial.,"This study sought to investigate associations between levels of high-sensitivity c-reactive protein (hsCRP) prior to treatment and change in depressive symptoms and cognition in a short-term, double-blind, placebo-controlled study of lurasidone in children and adolescents with bipolar I depression. Patients 10-17 years of age with a DSM-5 diagnosis of bipolar I depression were randomized to 6 weeks of double-blind treatment with flexibly dosed lurasidone (20-80 mg/day) (n = 173) or placebo (n = 170). The primary efficacy measure was change from baseline to week 6 in the Children's Depression Rating Scale, Revised (CDRS-R). Treatment response was defined as 50% or greater improvement on the CDRS-R from baseline to week 6. Cognitive function was evaluated with the computerized Brief Cogstate Battery at baseline and week 6. Analyses were adjusted for baseline BMI, as well as age. HsCRP was evaluated as a logarithmically transformed continuous variable and as a categorical variable dichotomized into lower (<1 mg/L) and higher (≥1 mg/L) subgroups. A significant interaction was found between baseline hsCRP and treatment group for change in CDRS-R score at study endpoint, with larger placebo-corrected effect sizes for lurasidone in the higher baseline hsCRP group (≥1 mg/L). A significant BMI-by-hsCRP-by-treatment interaction was found for response rate with higher baseline hsCRP levels associated with greater antidepressant response to lurasidone (vs. placebo) in the normal BMI range subgroup (NNT = 2 in higher hsCRP vs. NNT = 5 in lower hsCRP groups) but not in the overweight/obese patients (NNT = 6 in higher hsCRP vs. NNT = 5 in lower hsCRP). Similarly, a significant interaction effect was observed for the combination of hsCRP and BMI on the procognitive effect of lurasidone, with higher baseline hsCRP levels being associated with improvement in cognitive function for lurasidone (vs placebo) in the normal BMI range subgroup but not in overweight/obese patients. These results suggest that young patients with bipolar depression with normal weight and higher levels of pre-treatment CRP may show a greater placebo-adjusted improvement in depressive symptoms and cognitive performance when treated with lurasidone. If these findings are confirmed in future prospective studies, CRP and BMI may prove to be useful diagnostic and predictive biomarkers in the treatment with lurasidone of children and adolescents with bipolar depression.",2020,"A significant interaction was found between baseline hsCRP and treatment group for change in CDRS-R score at study endpoint, with larger placebo-corrected effect sizes for lurasidone in the higher baseline hsCRP group (≥1 mg/L).","['young patients with bipolar depression with normal weight', 'children and adolescents with bipolar I depression', 'Patients 10-17\xa0years of age with a DSM-5 diagnosis of bipolar I depression', 'children and adolescents with bipolar depression']","['flexibly dosed lurasidone', 'lurasidone', 'high-sensitivity c-reactive protein (hsCRP', 'placebo', 'lurasidone (vs placebo', 'lurasidone treatment', 'HsCRP']","['Cognitive function', 'CDRS-R score', 'depressive symptoms and cognitive performance', 'cognitive function', ""Children's Depression Rating Scale, Revised (CDRS-R"", 'CDRS-R']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0005587', 'cui_str': 'Depression, Bipolar'}, {'cui': 'C2712185', 'cui_str': 'Normal weight (finding)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0443156', 'cui_str': 'Bipolar (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}]","[{'cui': 'C2003424', 'cui_str': 'lurasidone'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0086132', 'cui_str': 'Depressive Symptoms'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0222045'}]",,0.165198,"A significant interaction was found between baseline hsCRP and treatment group for change in CDRS-R score at study endpoint, with larger placebo-corrected effect sizes for lurasidone in the higher baseline hsCRP group (≥1 mg/L).","[{'ForeName': 'Charles L', 'Initials': 'CL', 'LastName': 'Raison', 'Affiliation': 'Department of Human Development and Family Studies, School of Human Ecology, University of Wisconsin-Madison, 1300 Linden Drive, Madison, WI 53706, USA; Department of Psychiatry, School of Medicine and Public Health, University of Wisconsin-Madison, 6001 Research Park Blvd, Madison, WI 53719, USA. Electronic address: raison@wisc.edu.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Siu', 'Affiliation': ""COS & Associates Ltd., 20/F Central Tower, 28 Queen's Rd, Central District, Hong Kong.""}, {'ForeName': 'Andrei', 'Initials': 'A', 'LastName': 'Pikalov', 'Affiliation': 'Sunovion Pharmaceuticals Inc., 1 Bridge Plaza North, Suite 510, Fort Lee, NJ, USA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Tocco', 'Affiliation': 'Sunovion Pharmaceuticals Inc., 1 Bridge Plaza North, Suite 510, Fort Lee, NJ, USA.'}, {'ForeName': 'Antony', 'Initials': 'A', 'LastName': 'Loebel', 'Affiliation': 'Sunovion Pharmaceuticals Inc., 1 Bridge Plaza North, Suite 510, Fort Lee, NJ, USA.'}]","Brain, behavior, and immunity",['10.1016/j.bbi.2019.12.010'] 3137,30874454,"Re: ""Desvenlafaxine Versus Placebo in a Fluoxetine-Referenced Study of Children and Adolescents with Major Depressive Disorder: Design, Definitions, and Ongoing Challenges for Child and Adolescent Psychopharmacology Research"" by Strawn JR and Croarkin PE (J Child Adolesc Psychopharmacol 2018;28:(5)363).",,2019,,['Children and Adolescents with Major Depressive Disorder'],"['Desvenlafaxine Versus Placebo', 'Fluoxetine']",[],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C1269683', 'cui_str': 'Major Depressive Disorder'}]","[{'cui': 'C1880288', 'cui_str': 'Desvenlafaxine'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0016365', 'cui_str': 'Fluoxetine'}]",[],,0.0136516,,"[{'ForeName': 'Karen L', 'Initials': 'KL', 'LastName': 'Weihs', 'Affiliation': '1 Department of Psychiatry, University of Arizona, Tucson, Arizona.'}, {'ForeName': 'Dalia B', 'Initials': 'DB', 'LastName': 'Wajsbrot', 'Affiliation': '2 Pfizer, Inc., New York, New York.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Chiles', 'Affiliation': '3 Pfizer, Inc, Collegeville, Pennsylvania.'}, {'ForeName': 'Sara', 'Initials': 'S', 'LastName': 'Ramaker', 'Affiliation': '3 Pfizer, Inc, Collegeville, Pennsylvania.'}, {'ForeName': 'Phil', 'Initials': 'P', 'LastName': 'Chappell', 'Affiliation': '4 Pfizer, Inc., Groton, Connecticut.'}]",Journal of child and adolescent psychopharmacology,['10.1089/cap.2018.0163'] 3138,31605616,The Effect of Maternal Multiple Micronutrient Supplementation on Female Early Infant Mortality Is Fully Mediated by Increased Gestation Duration and Intrauterine Growth.,"BACKGROUND Maternal micronutrient supplementation in pregnancy (MMS) has been shown to improve birth weight among infants in low- and middle-income countries. Recent evidence suggests that the survival benefits of MMS are greater for female infants compared to male infants, but the mechanisms leading to differential effects remain unclear. OBJECTIVE The objective of this study was to examine the potential mechanisms through which MMS acts on infant mortality among Tanzanian infants. METHODS We used data collected from pregnant women and newborns in a randomized, double-blind, placebo-controlled trial of MMS conducted in Tanzania to examine mediators of the effect of MMS on 6-wk infant mortality (NCT00197548). Causal mediation analyses with the counterfactual approach were conducted to assess the contributions of MMS on survival via their effects on birth weight, gestational age, weight-for-gestational age, and the joint effect of gestational age and weight-for-gestational age. The weighting method allowed for interaction between gestational age and weight-for-gestational age. RESULTS Among 7486 newborns, the effect of MMS on 6-wk survival was fully mediated (100%) through the joint effect of gestational age and weight-for-gestational age. MMS was also found to have a significant natural indirect effect through increased birth weight (P-value < 0.001) that explained 75% of the total effect on 6-wk mortality. When analyses were stratified by sex, changes in gestational age and weight-for-gestational age fully mediated the mortality effect among female infants (n = 3570), but these mediators only explained 34% of the effect among males (n = 3833). CONCLUSIONS The potential sex-specific effects of MMS on mortality may be a result of differences in mechanisms related to birth outcomes. In the context of the Tanzanian trial, the observed effect of MMS on 6-wk mortality for female infants was entirely mediated by increased gestation duration and improved intrauterine growth, while these mechanisms did not appear to be major contributors among male infants.",2020,"When analyses were stratified by sex, changes in gestational age and weight-for-gestational age fully mediated the mortality effect among female infants (n = 3570), but these mediators only explained 34% of the effect among males (n = 3833). ","['female infants', 'male infants', 'pregnant women and newborns', 'Tanzanian infants', '7486 newborns']","['placebo', 'MMS', 'Maternal Multiple Micronutrient Supplementation', 'Maternal micronutrient supplementation']","['6-wk survival', 'Female Early Infant Mortality', 'birth weight', 'gestation duration and improved intrauterine growth', 'survival benefits of MMS']","[{'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0021289', 'cui_str': 'Newborns'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0026591', 'cui_str': 'Mothers'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0282575', 'cui_str': 'Micronutrients'}]","[{'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0021278', 'cui_str': 'Infant Mortality'}, {'cui': 'C0005612', 'cui_str': 'Birth Weight'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0694756', 'cui_str': 'Intrauterine (qualifier value)'}, {'cui': 'C0018270', 'cui_str': 'Growth'}]",,0.27157,"When analyses were stratified by sex, changes in gestational age and weight-for-gestational age fully mediated the mortality effect among female infants (n = 3570), but these mediators only explained 34% of the effect among males (n = 3833). ","[{'ForeName': 'Mary K', 'Initials': 'MK', 'LastName': 'Quinn', 'Affiliation': 'Department of Global Health and Population, Harvard TH Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Emily R', 'Initials': 'ER', 'LastName': 'Smith', 'Affiliation': 'Department of Global Health and Population, Harvard TH Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Paige L', 'Initials': 'PL', 'LastName': 'Williams', 'Affiliation': 'Department of Biostatistics, Harvard TH Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Willy', 'Initials': 'W', 'LastName': 'Urassa', 'Affiliation': 'Department of Microbiology and Immunology, Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania.'}, {'ForeName': 'Joy', 'Initials': 'J', 'LastName': 'Shi', 'Affiliation': 'Department of Epidemiology, Harvard TH Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Gernard', 'Initials': 'G', 'LastName': 'Msamanga', 'Affiliation': 'Department of Community Health, Muhimbili University of Health and Allied Sciences, Dar es Salaam, Tanzania.'}, {'ForeName': 'Wafaie W', 'Initials': 'WW', 'LastName': 'Fawzi', 'Affiliation': 'Department of Global Health and Population, Harvard TH Chan School of Public Health, Boston, MA, USA.'}, {'ForeName': 'Christopher R', 'Initials': 'CR', 'LastName': 'Sudfeld', 'Affiliation': 'Department of Global Health and Population, Harvard TH Chan School of Public Health, Boston, MA, USA.'}]",The Journal of nutrition,['10.1093/jn/nxz246'] 3139,31594736,Single Versus Maintenance Intravesical Chemotherapy for the Prevention of Bladder Recurrence after Radical Nephroureterectomy for Upper Tract Urothelial Carcinoma: A Randomized Clinical Trial.,"INTRODUCTION The objective of this study was to determine the efficiency of 1-year maintenance intravesical chemotherapy (MIC) in reducing bladder recurrence (BR) after radical nephroureterectomy (RNU) for upper tract urothelial carcinoma compared with single intravesical instillation (SIC). PATIENTS AND METHODS Between January 2015 and May 2017, patients who underwent RNU were randomized to receive SIC (epirubicin 50 mg) or MIC (once weekly for 6 weeks plus once monthly for 1 year). The primary outcome was the rate of histologically proven BR. The secondary outcomes included chemotherapy-related toxicities and disease-specific survival (DSS). Thirty-five patients in each arm were required to achieve a power of 80%. RESULTS A total of 38 (SIC) and 36 (MIC) patients were analyzed. In SIC, BR developed in 5 (13.2%) over a median follow-up of 3 months (range, 3-6 months) compared with 9 (25%) patients over 12 months (range, 3-28 months) in MIC (P = .08). The 6- and 12-month BR-free survivals were the same (86.8%) in SIC versus 88.9% and 83.3% in MIC, respectively (P = .2). Lymphovascular invasion was significantly associated with BR (P = .04). Post-RNU intravesical chemotherapy regimens did not alter DSS. Blood transfusion and advanced tumor stage were independent predictors for DSS. No significant medication toxicity was reported. CONCLUSIONS Following RNU, MIC did not change the natural course of BR beyond a single instillation apart from potentially delaying its occurrence. Lymphovascular invasion and blood transfusion were associated with worse BR and DSS outcomes, respectively.",2019,"The 6- and 12-month BR-free survivals were the same (86.8%) in SIC versus 88.9% and 83.3% in MIC, respectively","['A total of 38 (SIC) and 36 (MIC) patients were analyzed', 'upper tract urothelial carcinoma', 'Upper Tract Urothelial Carcinoma', 'Between January 2015 and May 2017, patients who underwent RNU']","['radical nephroureterectomy (RNU', 'SIC (epirubicin 50 mg) or MIC', 'Radical Nephroureterectomy', 'single intravesical instillation (SIC', 'maintenance intravesical chemotherapy (MIC', 'Single Versus Maintenance Intravesical Chemotherapy']","['rate of histologically proven BR', 'Blood transfusion and advanced tumor stage', 'Lymphovascular invasion and blood transfusion', 'chemotherapy-related toxicities and disease-specific survival (DSS', 'DSS', 'Lymphovascular invasion', 'bladder recurrence (BR', 'Bladder Recurrence', 'medication toxicity', '6- and 12-month BR-free survivals']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0007138', 'cui_str': 'Carcinoma, Transitional Cell'}]","[{'cui': 'C0439807', 'cui_str': 'Radical - extent'}, {'cui': 'C0027732', 'cui_str': 'Ureteronephrectomy'}, {'cui': 'C0014582', 'cui_str': 'Epirubicin'}, {'cui': 'C0427978', 'cui_str': 'Minimum Inhibitory Concentration'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0021917', 'cui_str': 'Instillation, Bladder'}, {'cui': 'C0024501', 'cui_str': 'Maintenances'}, {'cui': 'C0442124', 'cui_str': 'Intravesical approach (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C0456369', 'cui_str': 'Proven (qualifier value)'}, {'cui': 'C1273858', 'cui_str': 'Transfusion Medicine'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0475455', 'cui_str': 'T category'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0005682', 'cui_str': 'Bladder'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]",,0.171935,"The 6- and 12-month BR-free survivals were the same (86.8%) in SIC versus 88.9% and 83.3% in MIC, respectively","[{'ForeName': 'Ahmed M', 'Initials': 'AM', 'LastName': 'Harraz', 'Affiliation': 'Urology and Nephrology Center, Mansoura University, Mansoura, Egypt. Electronic address: Ahmed.harraz@hotmail.com.'}, {'ForeName': 'Magdy', 'Initials': 'M', 'LastName': 'El-Shabrawy', 'Affiliation': 'Urology and Nephrology Center, Mansoura University, Mansoura, Egypt.'}, {'ForeName': 'Ahmed R', 'Initials': 'AR', 'LastName': 'El-Nahas', 'Affiliation': 'Urology and Nephrology Center, Mansoura University, Mansoura, Egypt.'}, {'ForeName': 'Hamdy', 'Initials': 'H', 'LastName': 'El-Kappany', 'Affiliation': 'Urology and Nephrology Center, Mansoura University, Mansoura, Egypt.'}, {'ForeName': 'Yasser', 'Initials': 'Y', 'LastName': 'Osman', 'Affiliation': 'Urology and Nephrology Center, Mansoura University, Mansoura, Egypt.'}]",Clinical genitourinary cancer,['10.1016/j.clgc.2019.07.019'] 3140,31601514,COMPARZ Post Hoc Analysis: Characterizing Pazopanib Responders With Advanced Renal Cell Carcinoma.,"BACKGROUND The phase III COMPARZ study showed noninferior efficacy of pazopanib versus sunitinib in advanced renal cell carcinoma. In this COMPARZ post hoc analysis we characterized pazopanib responders, patient subgroups with better outcomes, and the effect of dose modification on efficacy and safety. PATIENTS AND METHODS Patients were randomized to pazopanib 800 mg/d (n = 557) or sunitinib 50 mg/d, 4 weeks on/2 weeks off (n = 553). Secondary end points included time to complete response (CR)/partial response (PR); the proportion of patients with CR/PR ≥10 months and progression-free survival (PFS) ≥10 months; efficacy in patients with baseline metastasis; and logistic regression analyses of patient characteristics associated with CR/PR ≥10 months. Median PFS, objective response rate (ORR), and safety were evaluated in patients with or without dose reductions or interruptions lasting ≥7 days. RESULTS Median time to response was numerically shorter for patients treated with pazopanib versus sunitinib (11.9 vs. 17.4 weeks). Similar percentages of pazopanib and sunitinib patients had CR/PR ≥10 months (14% and 13%, respectively), and PFS ≥10 months (31% and 34%, respectively). For patients without versus with adverse event (AE)-related dose reductions, median PFS, median overall survival, and ORR were 7.3 versus 12.5 months, 21.7 versus 36.8 months, and 22% versus 42% (all P < .0001) for pazopanib, and 5.5 versus 13.8 months, 18.1 versus 38.0 months, and 16% versus 34% (all P < .0001) for sunitinib; results were similar for dose interruptions. CONCLUSION Dose modifications when required because of AEs were associated with improved efficacy, suggesting that AEs might be used as a surrogate marker of adequate dosing for individual patients.",2019,"RESULTS Median time to response was numerically shorter for patients treated with pazopanib versus sunitinib (11.9 vs. 17.4 weeks).","['Patients', 'advanced renal cell carcinoma', 'Responders With Advanced Renal Cell Carcinoma']","['Pazopanib', 'pazopanib', 'COMPARZ Post', 'sunitinib']","['Median time to response', 'efficacy and safety', 'time to complete response (CR)/partial response (PR); the proportion of patients with CR/PR\xa0≥10 months and progression-free survival (PFS)\xa0≥10 months; efficacy', 'median PFS, median overall survival, and ORR', 'Median PFS, objective response rate (ORR), and safety']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0007134', 'cui_str': 'Nephroid Carcinoma'}]","[{'cui': 'C1831796', 'cui_str': 'pazopanib'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C1176020', 'cui_str': 'sunitinib'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}]",,0.108855,"RESULTS Median time to response was numerically shorter for patients treated with pazopanib versus sunitinib (11.9 vs. 17.4 weeks).","[{'ForeName': 'Cora N', 'Initials': 'CN', 'LastName': 'Sternberg', 'Affiliation': 'Weill Cornell Medicine, Hematology/Oncology, New York, NY. Electronic address: cns9006@cornell.med.edu.'}, {'ForeName': 'Robert J', 'Initials': 'RJ', 'LastName': 'Motzer', 'Affiliation': 'Memorial Sloan Kettering Cancer Center, New York, NY.'}, {'ForeName': 'Thomas E', 'Initials': 'TE', 'LastName': 'Hutson', 'Affiliation': 'Texas Oncology/Baylor Sammons Cancer Center, Dallas, TX.'}, {'ForeName': 'Toni K', 'Initials': 'TK', 'LastName': 'Choueiri', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute, Harvard Medical School, Boston, MA.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Kollmannsberger', 'Affiliation': 'Division of Medical Oncology, The University of British Columbia, BCCA Vancouver Cancer Centre, Vancouver, British Columbia, Canada.'}, {'ForeName': 'Georg A', 'Initials': 'GA', 'LastName': 'Bjarnason', 'Affiliation': 'Division of Medical Oncology, Sunnybrook Odette Cancer Centre, University of Toronto, Toronto, Ontario, Canada.'}, {'ForeName': '', 'Initials': '', 'LastName': 'Paul Nathan', 'Affiliation': 'Department of Medical Oncology, Mount Vernon Cancer Center, Northwood, United Kingdom.'}, {'ForeName': 'Camillo', 'Initials': 'C', 'LastName': 'Porta', 'Affiliation': 'Medical Oncology, I.R.C.C.S. San Matteo University Hospital Foundation, Pavia, Italy.'}, {'ForeName': 'Viktor', 'Initials': 'V', 'LastName': 'Grünwald', 'Affiliation': 'University Hospital Essen, West-German Cancer Center, Internal Medicine (Tumor research) and Clinic for Urology, Essen, Germany.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Dezzani', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ.'}, {'ForeName': 'Jackie', 'Initials': 'J', 'LastName': 'Han', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ.'}, {'ForeName': 'Nizar M', 'Initials': 'NM', 'LastName': 'Tannir', 'Affiliation': 'Department of Genitourinary Medical Oncology, The University of Texas M.D. Anderson Cancer Center, Houston, TX.'}]",Clinical genitourinary cancer,['10.1016/j.clgc.2019.01.015'] 3141,25361992,Impact of enzalutamide on quality of life in men with metastatic castration-resistant prostate cancer after chemotherapy: additional analyses from the AFFIRM randomized clinical trial.,"BACKGROUND To present longitudinal changes in Functional Assessment of Cancer Therapy-Prostate (FACT-P) scores during 25-week treatment with enzalutamide or placebo in men with progressive metastatic castration-resistant prostate cancer (mCRPC) after chemotherapy in the AFFIRM trial. PATIENTS AND METHODS Patients were randomly assigned to enzalutamide 160 mg/day or placebo. FACT-P was completed before randomization, at weeks 13, 17, 21, and 25, and every 12 weeks thereafter while on study treatment. Longitudinal changes in FACT-P scores from baseline to 25 weeks were analyzed using a mixed effects model for repeated measures (MMRM), with a pattern mixture model (PMM) applied as secondary analysis to address non-ignorable missing data. Cumulative distribution function (CDF) plots were generated and different methodological approaches and models for handling missing data were applied. Due to the exploratory nature of the analyses, adjustments for multiple comparisons were not made. AFFIRM is registered with ClinicalTrials.gov, number NCT00974311. RESULTS The intention-to-treat FACT-P population included 938 patients (enzalutamide, n = 674; placebo n = 264) with evaluable FACT-P assessments at baseline and ≥1 post-baseline assessment. After 25 weeks, the mean FACT-P total score decreased by 1.52 points with enzalutamide compared with 13.73 points with placebo (P < 0.001). In addition, significant treatment differences at week 25 favoring enzalutamide were evident for all FACT-P subscales and indices, whether analyzed by MMRM or PMM. CDF plots revealed differences favoring enzalutamide compared with placebo across the full range of possible response levels for FACT-P total and all disease- and symptom-specific subscales/indices. CONCLUSION In men with progressive mCRPC after docetaxel-based chemotherapy, enzalutamide is superior to placebo in health-related quality-of-life outcomes, regardless of analysis model or threshold selected for meaningful response. CLINICAL TRIAL NUMBER NCT00974311.",2015,"After 25 weeks, the mean FACT-P total score decreased by 1.52 points with enzalutamide compared with 13.73 points with placebo (P < 0.001).","['938 patients (enzalutamide, n = 674; placebo n = 264) with evaluable FACT-P assessments at baseline and ≥1 post-baseline assessment', 'men with progressive metastatic castration-resistant prostate cancer (mCRPC) after chemotherapy in the AFFIRM trial', 'Patients', 'men with progressive mCRPC after', 'men with metastatic castration-resistant prostate cancer after chemotherapy']","['placebo', 'enzalutamide or placebo', 'docetaxel-based chemotherapy, enzalutamide', 'enzalutamide 160 mg/day or placebo', 'enzalutamide']","['Cumulative distribution function (CDF) plots', 'mean FACT-P total score', 'quality of life']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C3496793', 'cui_str': 'enzalutamide'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0205329', 'cui_str': 'Progressive (qualifier value)'}, {'cui': 'C4721208', 'cui_str': 'Metastatic castration-resistant prostate cancer'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3496793', 'cui_str': 'enzalutamide'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C4319554', 'cui_str': '160'}, {'cui': 'C0439422', 'cui_str': 'mg/day'}]","[{'cui': 'C0037775', 'cui_str': 'Distributions (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0034380'}]",264.0,0.540322,"After 25 weeks, the mean FACT-P total score decreased by 1.52 points with enzalutamide compared with 13.73 points with placebo (P < 0.001).","[{'ForeName': 'D', 'Initials': 'D', 'LastName': 'Cella', 'Affiliation': 'Department of Medical Social Sciences, Northwestern University Feinberg School of Medicine, Chicago, USA. Electronic address: d-cella@northwestern.edu.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Ivanescu', 'Affiliation': 'Consulting, Quintiles, Hoofddorp.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Holmstrom', 'Affiliation': 'Global Data Science, Health Economics & Outcomes Research, Astellas Pharma Global Development, Leiden, The Netherlands.'}, {'ForeName': 'C N', 'Initials': 'CN', 'LastName': 'Bui', 'Affiliation': 'Health Economics & Clinical Outcomes Research, Astellas Pharma US, Inc., Northbrook, USA.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Spalding', 'Affiliation': 'Health Economics & Clinical Outcomes Research, Astellas Pharma US, Inc., Northbrook, USA.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Fizazi', 'Affiliation': 'Institut Gustave Roussy, University of Paris Sud, Villejuif, France.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdu510'] 3142,32024950,"Daratumumab monotherapy for patients with intermediate-risk or high-risk smoldering multiple myeloma: a randomized, open-label, multicenter, phase 2 study (CENTAURUS).","Current guidelines for smoldering multiple myeloma (SMM) recommend active monitoring until the onset of multiple myeloma (MM) before initiating treatment or enrollment in a clinical trial. Earlier intervention may delay progression to MM. In CENTAURUS, 123 patients with intermediate-risk or high-risk SMM were randomly assigned to daratumumab 16 mg/kg intravenously on extended intense (intense), extended intermediate (intermediate), or short dosing schedules. At the prespecified primary analysis (15.8-month median follow-up), the complete response (CR) rates (co-primary endpoint) were 2.4%, 4.9%, and 0% for intense, intermediate, and short dosing, respectively; the co-primary endpoint of CR rate >15% was not met. Progressive disease (PD)/death rates (number of patients who progressed or died divided by total duration of progression-free survival [PFS] in patient-years; co-primary endpoint) for intense, intermediate, and short dosing were 0.055 (80% confidence interval [CI], 0.014-0.096), 0.102 (80% CI, 0.044-0.160), and 0.206 (80% CI, 0.118-0.295), respectively, translating to a median PFS ≥24 months in all arms (P < 0.0001, <0.0001, and =0.0213, respectively). With longer follow-up (median follow-up, 25.9 months), CR rates were 4.9%, 9.8%, and 0% for intense, intermediate, and short dosing, respectively. PD/death rates for intense, intermediate, and short dosing were 0.059 (80% CI, 0.025-0.092), 0.107 (80% CI, 0.058-0.155), and 0.150 (80% CI, 0.089-0.211), respectively, again translating to a median PFS ≥ 24 months in all arms (P < 0.0001 for all arms). Twenty-four-month PFS rates were 89.9% (90% CI, 78.5-95.4%), 82.0% (90% CI, 69.0-89.9%), and 75.3% (90% CI, 61.1-85.0%) for intense, intermediate, and short dosing, respectively. Pharmacokinetic analyses indicated that intense dosing maintained target-saturating trough concentrations in most patients throughout weekly, every-2-week, and every-4-week dosing periods. No new safety signals were observed. These data provide the basis for an ongoing phase 3 study of daratumumab in SMM.",2020,"PD/death rates for intense, intermediate, and short dosing were 0.059 (80% CI, 0.025-0.092), 0.107 (80% CI, 0.058-0.155), and 0.150 (80% CI, 0.089-0.211), respectively, again translating to a median PFS ≥ 24 months in all arms (P < 0.0001 for all arms).","['patients with intermediate-risk or high-risk smoldering multiple myeloma', '123 patients with intermediate-risk or high-risk SMM']","['Daratumumab monotherapy', 'daratumumab 16\u2009mg/kg intravenously on extended intense (intense), extended intermediate (intermediate']","['Progressive disease (PD)/death rates', 'CR rates', 'CR rate', 'PD/death rates', 'PFS rates', 'complete response (CR) rates']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C1531608', 'cui_str': 'Asymptomatic Multiple Myeloma'}]","[{'cui': 'C2346801', 'cui_str': 'daratumumab'}, {'cui': 'C0439272', 'cui_str': 'microgram/g'}, {'cui': 'C0231449', 'cui_str': 'Extended (qualifier value)'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}]","[{'cui': 'C0205329', 'cui_str': 'Progressive (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205848', 'cui_str': 'Death Rate'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]",123.0,0.0578349,"PD/death rates for intense, intermediate, and short dosing were 0.059 (80% CI, 0.025-0.092), 0.107 (80% CI, 0.058-0.155), and 0.150 (80% CI, 0.089-0.211), respectively, again translating to a median PFS ≥ 24 months in all arms (P < 0.0001 for all arms).","[{'ForeName': 'C Ola', 'Initials': 'CO', 'LastName': 'Landgren', 'Affiliation': 'Department of Medicine, Myeloma Service, Memorial Sloan Kettering Cancer Center, New York, NY, USA. landgrec@mskcc.org.'}, {'ForeName': 'Ajai', 'Initials': 'A', 'LastName': 'Chari', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, NY, USA.'}, {'ForeName': 'Yael C', 'Initials': 'YC', 'LastName': 'Cohen', 'Affiliation': 'Department of Hematology, Tel-Aviv Sourasky (Ichilov) Medical Center, and Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Spencer', 'Affiliation': 'Malignant Haematology and Stem Cell Transplantation Service, Alfred Health-Monash University, Melbourne, VIC, Australia.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Voorhees', 'Affiliation': 'Levine Cancer Institute/Atrium Health, Charlotte, NC, USA.'}, {'ForeName': 'Jane A', 'Initials': 'JA', 'LastName': 'Estell', 'Affiliation': 'Haematology Department, Concord Cancer Centre, Concord Hospital, University of Sydney, Concord, NSW, Australia.'}, {'ForeName': 'Irwindeep', 'Initials': 'I', 'LastName': 'Sandhu', 'Affiliation': 'Department of Medicine, University of Alberta, Edmonton, AB, Canada.'}, {'ForeName': 'Matthew W', 'Initials': 'MW', 'LastName': 'Jenner', 'Affiliation': 'Southampton General Hospital, Southampton, UK.'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Williams', 'Affiliation': 'Department of Clinical Haematology, Nottingham University Hospitals, Nottinghamshire, UK.'}, {'ForeName': 'Michele', 'Initials': 'M', 'LastName': 'Cavo', 'Affiliation': 'Department of Experimental, Diagnostic and Specialty Medicine, ""Seràgnoli"" Institute of Hematology, University of Bologna, Bologna, Italy.'}, {'ForeName': 'Niels W C J', 'Initials': 'NWCJ', 'LastName': 'van de Donk', 'Affiliation': 'Department of Hematology, VU University Medical Center, Amsterdam, The Netherlands.'}, {'ForeName': 'Meral', 'Initials': 'M', 'LastName': 'Beksac', 'Affiliation': 'Department of Hematology, Ankara University, Ankara, Turkey.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Moreau', 'Affiliation': 'University Hospital Hôtel-Dieu, Nantes, France.'}, {'ForeName': 'Hartmut', 'Initials': 'H', 'LastName': 'Goldschmidt', 'Affiliation': 'University Hospital Heidelberg and National Center of Tumor Diseases (NCT), Heidelberg, Germany.'}, {'ForeName': 'Steven', 'Initials': 'S', 'LastName': 'Kuppens', 'Affiliation': 'Janssen Research & Development, Beerse, Belgium.'}, {'ForeName': 'Rajesh', 'Initials': 'R', 'LastName': 'Bandekar', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, PA, USA.'}, {'ForeName': 'Pamela L', 'Initials': 'PL', 'LastName': 'Clemens', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, PA, USA.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Neff', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, PA, USA.'}, {'ForeName': 'Christoph', 'Initials': 'C', 'LastName': 'Heuck', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, PA, USA.'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Qi', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, PA, USA.'}, {'ForeName': 'Craig C', 'Initials': 'CC', 'LastName': 'Hofmeister', 'Affiliation': 'Department of Hematology & Oncology, Winship Cancer Institute of Emory University, Atlanta, GA, USA. Craig.Hofmeister@emory.edu.'}]",Leukemia,['10.1038/s41375-020-0718-z'] 3143,32024528,Human arm weight compensation in rehabilitation robotics: efficacy of three distinct methods.,"BACKGROUND Arm weight compensation with rehabilitation robots for stroke patients has been successfully used to increase the active range of motion and reduce the effects of pathological muscle synergies. However, the differences in structure, performance, and control algorithms among the existing robotic platforms make it hard to effectively assess and compare human arm weight relief. In this paper, we introduce criteria for ideal arm weight compensation, and furthermore, we propose and analyze three distinct arm weight compensation methods (Average, Full, Equilibrium) in the arm rehabilitation exoskeleton 'ARMin'. The effect of the best performing method was validated in chronic stroke subjects to increase the active range of motion in three dimensional space. METHODS All three methods are based on arm models that are generalizable for use in different robotic devices and allow individualized adaptation to the subject by model parameters. The first method Average uses anthropometric tables to determine subject-specific parameters. The parameters for the second method Full are estimated based on force sensor data in predefined resting poses. The third method Equilibrium estimates parameters by optimizing an equilibrium of force/torque equations in a predefined resting pose. The parameters for all three methods were first determined and optimized for temporal and spatial estimation sensitivity. Then, the three methods were compared in a randomized single-center study with respect to the remaining electromyography (EMG) activity of 31 healthy participants who performed five arm poses covering the full range of motion with the exoskeleton robot. The best method was chosen for feasibility tests with three stroke patients. In detail, the influence of arm weight compensation on the three dimensional workspace was assessed by measuring of the horizontal workspace at three different height levels in stroke patients. RESULTS All three arm weight compensation methods reduced the mean EMG activity of healthy subjects to at least 49% compared with the no compensation reference. The Equilibrium method outperformed the Average and the Full methods with a highly significant reduction in mean EMG activity by 19% and 28% respectively. However, upon direct comparison, each method has its own individual advantages such as in set-up time, cost, or required technology. The horizontal workspace assessment in poststroke patients with the Equilibrium method revealed potential workspace size-dependence of arm height, while weight compensation helped maximize the workspace as much as possible. CONCLUSION Different arm weight compensation methods were developed according to initially defined criteria. The methods were then analyzed with respect to their sensitivity and required technology. In general, weight compensation performance improved with the level of technology, but increased cost and calibration efforts. This study reports a systematic way to analyze the efficacy of different weight compensation methods using EMG. Additionally, the feasibility of the best method, Equilibrium, was shown by testing with three stroke patients. In this test, a height dependence of the workspace size also seemed to be present, which further highlights the importance of patient-specific weight compensation, particularly for training at different arm heights. TRIAL REGISTRATION ClinicalTrials.gov,NCT02720341. Registered 25 March 2016.",2020,The Equilibrium method outperformed the Average and the Full methods with a highly significant reduction in mean EMG activity by 19% and 28% respectively.,"['chronic stroke subjects', '31 healthy participants who performed five arm poses covering the full range of motion with the exoskeleton robot', 'poststroke patients', 'stroke patients']",[],['mean EMG activity'],"[{'cui': 'C3536593', 'cui_str': 'Chronic stroke'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0439844', 'cui_str': 'Covered (qualifier value)'}, {'cui': 'C0080078', 'cui_str': 'Range of Motion'}, {'cui': 'C0336537', 'cui_str': 'Robot, device (physical object)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}]",[],"[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0013839', 'cui_str': 'Electromyography'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}]",3.0,0.0254357,The Equilibrium method outperformed the Average and the Full methods with a highly significant reduction in mean EMG activity by 19% and 28% respectively.,"[{'ForeName': 'Fabian', 'Initials': 'F', 'LastName': 'Just', 'Affiliation': 'Sensory-Motor Systems (SMS) Lab, Institute of Robotics and Intelligent Systems (IRIS), Department of Health Sciences and Technology (D-HEST), ETH Zurich, Switzerland and Reharobotics Group, Spinal Cord Injury Center, Balgrist University Hospital, Medical Faculty, University of Zurich, Switzerland, Lengghalde 5, Zurich, 8092, Switzerland. fabian.just@hest.ethz.ch.'}, {'ForeName': 'Özhan', 'Initials': 'Ö', 'LastName': 'Özen', 'Affiliation': 'Motor Learning and Neurorehabilitation Laboratory, ARTORG Center for Biomedical Engineering Research, University of Bern, Freiburgstrasse 3, Bern, 3010, Switzerland.'}, {'ForeName': 'Stefano', 'Initials': 'S', 'LastName': 'Tortora', 'Affiliation': 'IAS-Lab, Department of Information Engineering, University of Padova, via Giovanni Gradenigo 6a, Padova, 35131, Italy.'}, {'ForeName': 'Verena', 'Initials': 'V', 'LastName': 'Klamroth-Marganska', 'Affiliation': 'Institute of Occupational Therapy, School of Health Professions, Zurich University of Applied Sciences, Technikumstrasse 81, Winterthur, 8401, Switzerland.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Riener', 'Affiliation': 'Sensory-Motor Systems (SMS) Lab, Institute of Robotics and Intelligent Systems (IRIS), Department of Health Sciences and Technology (D-HEST), ETH Zurich, Switzerland and Reharobotics Group, Spinal Cord Injury Center, Balgrist University Hospital, Medical Faculty, University of Zurich, Switzerland, Lengghalde 5, Zurich, 8092, Switzerland.'}, {'ForeName': 'Georg', 'Initials': 'G', 'LastName': 'Rauter', 'Affiliation': 'Sensory-Motor Systems (SMS) Lab, Institute of Robotics and Intelligent Systems (IRIS), Department of Health Sciences and Technology (D-HEST), ETH Zurich, Switzerland and Reharobotics Group, Spinal Cord Injury Center, Balgrist University Hospital, Medical Faculty, University of Zurich, Switzerland, Lengghalde 5, Zurich, 8092, Switzerland.'}]",Journal of neuroengineering and rehabilitation,['10.1186/s12984-020-0644-3'] 3144,32026537,"Effect of Cichorium intybus seeds supplementation on the markers of glycemic control, oxidative stress, inflammation, and lipid profile in type 2 diabetes mellitus: A randomized, double-blind placebo study.","Diabetes mellitus is associated with increased levels of inflammation and oxidative stress in patients. The aim of the present study was to test the hypothesis that aqueous extract of Cichorium intybus seeds (AECIS) would have add-on beneficial effect in type 2 diabetes mellitus (T2DM). In this double-blind randomized clinical study, 150 subjects were enrolled to assess the add-on efficacy and safety of AECIS in T2DM patients. The subjects were randomized (1:1) to the AECIS (n = 51) and placebo (n = 49) groups. The subjects in both groups continued to take prescribed doses of metformin. The standardization of AECIS was carried out by liquid chromatography-mass spectrometry and phytochemical analysis. The mean hemoglobin A1c (HbA1c) level in the AECIS and placebo groups at baseline was 8.6% and 8.5%, respectively. Mean values of HbA1c at the end of 12 weeks of intervention were 7.42% in the AECIS group (a reduction of 1.18% from baseline) and 8.4% in the placebo group (mean reduction of 0.1% from baseline). Besides, significant reduction in inflammation, oxidative stress, and hypertriglyceridemia was seen in the AECIS group (p < .05). The study shows for the first time that AECIS supplementation ameliorates the disease progression and it is beneficial as a potential adjunct dietary supplement for the management of T2DM.",2020,"Besides, significant reduction in inflammation, oxidative stress, and hypertriglyceridemia was seen in the AECIS group (p < .05).","['type 2 diabetes mellitus (T2DM', '150 subjects', 'patients', 'Diabetes mellitus', 'type 2 diabetes mellitus']","['metformin', 'AECIS', 'placebo', 'Cichorium intybus seeds supplementation', 'AECIS supplementation', 'aqueous extract of Cichorium intybus seeds (AECIS']","['efficacy and safety of AECIS', 'inflammation, oxidative stress, and hypertriglyceridemia', 'mean hemoglobin A1c (HbA1c) level', 'glycemic control, oxidative stress, inflammation, and lipid profile', 'Mean values of HbA1c', 'levels of inflammation and oxidative stress']","[{'cui': 'C0011860', 'cui_str': 'Diabetes Mellitus, Type 2'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}]","[{'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1145671', 'cui_str': 'Cichorium intybus'}, {'cui': 'C2752151', 'cui_str': 'Extract (qualifier value)'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0242606', 'cui_str': 'Oxidative Stress'}, {'cui': 'C0020557', 'cui_str': 'Hypertriglyceridemia'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C4521595', 'cui_str': 'Lcpl'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}]",150.0,0.1719,"Besides, significant reduction in inflammation, oxidative stress, and hypertriglyceridemia was seen in the AECIS group (p < .05).","[{'ForeName': 'Kailash', 'Initials': 'K', 'LastName': 'Chandra', 'Affiliation': 'Department of Biochemistry, HIMSR, Jamia Hamdard, New Delhi, India.'}, {'ForeName': 'Vineet', 'Initials': 'V', 'LastName': 'Jain', 'Affiliation': 'Department of Medicine, HIMSR, Jamia Hamdard, New Delhi, India.'}, {'ForeName': 'Azhar', 'Initials': 'A', 'LastName': 'Jabin', 'Affiliation': 'Department of Moalijat, School of Medicine (Unani), Jamia Hamdard, New Delhi, India.'}, {'ForeName': 'Shridhar', 'Initials': 'S', 'LastName': 'Dwivedi', 'Affiliation': 'Department of Cardiology, National Heart Institute, New Delhi, India.'}, {'ForeName': 'Santosh', 'Initials': 'S', 'LastName': 'Joshi', 'Affiliation': 'R&D Department, Hamdard Laboratories, Hamdard National Foundation, Ghaziabad, India.'}, {'ForeName': 'Sayeed', 'Initials': 'S', 'LastName': 'Ahmad', 'Affiliation': 'Bioactive Natural Product Laboratory, Department of Pharmacognosy and Phytochemistry, SPER, Jamia Hamdard, New Delhi, India.'}, {'ForeName': 'Swatantra K', 'Initials': 'SK', 'LastName': 'Jain', 'Affiliation': 'Department of Biochemistry, HIMSR, Jamia Hamdard, New Delhi, India.'}]",Phytotherapy research : PTR,['10.1002/ptr.6624'] 3145,25416687,Docetaxel plus oxaliplatin with or without fluorouracil or capecitabine in metastatic or locally recurrent gastric cancer: a randomized phase II study.,"BACKGROUND Docetaxel/cisplatin/infusional 5-fluorouracil (5-FU; DCF) is a standard chemotherapy regimen for patients with advanced gastric cancer (GC). This phase II study evaluated docetaxel/oxaliplatin (TE), docetaxel/oxaliplatin/5-FU (TEF), and docetaxel/oxaliplatin/capecitabine (TEX) in patients with advanced GC. PATIENTS AND METHODS Patients with metastatic or locally recurrent gastric adenocarcinoma (including carcinoma of the gastro-oesophageal junction) were randomly assigned (1 : 1 : 1) to TE, TEF, or TEX. Each regimen was tested at two doses before full evaluation at optimized dose levels. The primary end point was progression-free survival (PFS). Overall survival (OS), tumour response, and safety were also assessed. A therapeutic index (median PFS relative to the incidence of febrile neutropenia) was calculated for each regimen and compared with DCF (historical data). RESULTS Overall, 248 patients were randomly assigned to receive optimized dose treatment. Median PFS was longer with TEF (7.66 [95% confidence interval (CI): 6.97-9.40] months) versus TE (4.50 [3.68-5.32] months) and TEX (5.55 [4.30-6.37] months). Median OS was 14.59 (95% CI: 11.70-21.78) months for TEF versus 8.97 (7.79-10.87) months for TE and 11.30 (8.08-14.03) months for TEX. The rate of tumour response (complete or partial) was 46.6% (95% CI 35.9-57.5) for TEF versus 23.1% (14.3-34.0) for TE and 25.6% (16.6-36.4) for TEX. The frequency and type of adverse events (AEs) were similar across the three arms. Common grade 3/4 AEs were fatigue (21%), sensory neuropathy (14%), and diarrhoea (13%). Febrile neutropenia was reported in 2% (TEF), 14% (TE), and 9% (TEX) of patients. The therapeutic index was improved with TEF versus TEX, TE, or DCF. CONCLUSION These results suggest that TEF is worthy of evaluation as an arm in a phase III trial or as a backbone regimen for new targeted agents in advanced GC. CLINICALTRIALS.GOV: Identifier Trial registration number: NCT00382720.",2015,Median OS was 14.59 (95% CI: 11.70-21.78) months for TEF versus 8.97,"['metastatic or locally recurrent gastric cancer', 'patients with advanced gastric cancer (GC', 'patients with advanced GC', 'Patients with metastatic or locally recurrent gastric adenocarcinoma (including carcinoma of the gastro-oesophageal junction', '248 patients']","['Docetaxel plus oxaliplatin with or without fluorouracil or capecitabine', 'docetaxel/oxaliplatin (TE), docetaxel/oxaliplatin/5-FU (TEF), and docetaxel/oxaliplatin/capecitabine (TEX', 'TEF', 'TE, TEF, or TEX', 'Docetaxel/cisplatin/infusional 5-fluorouracil (5-FU; DCF']","['rate of tumour response (complete or partial', 'diarrhoea', 'febrile neutropenia', 'sensory neuropathy', 'Overall survival (OS), tumour response, and safety', 'Median PFS', 'Median OS', 'frequency and type of adverse events (AEs', 'Febrile neutropenia', 'progression-free survival (PFS']","[{'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0024623', 'cui_str': 'Cancer of Stomach'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C1704242', 'cui_str': 'Gastric (qualifier value)'}, {'cui': 'C0001418', 'cui_str': 'Adenoma, Malignant'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0007097', 'cui_str': 'Epithelioma'}, {'cui': 'C0014871', 'cui_str': 'Gastroesophageal Junction'}]","[{'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}]","[{'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0746883', 'cui_str': 'Febrile Neutropenia'}, {'cui': 'C0151313', 'cui_str': 'Sensory neuropathy (disorder)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",248.0,0.109933,Median OS was 14.59 (95% CI: 11.70-21.78) months for TEF versus 8.97,"[{'ForeName': 'E', 'Initials': 'E', 'LastName': 'Van Cutsem', 'Affiliation': 'Digestive Oncology, University Hospitals Leuven and KU Leuven, Leuven, Belgium. Electronic address: eric.vancutsem@uzleuven.be.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Boni', 'Affiliation': 'Department of Oncology, Arcispedale S. Maria Nuova-IRCCS, Reggio Emilia, Italy.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Tabernero', 'Affiliation': ""Department of Medical Oncology, Vall d'Hebron University Hospital and Institute of Oncology (VHIO), Universitat Autònoma de Barcelona, Barcelona.""}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Massuti', 'Affiliation': 'Medical Oncology Service, Alicante University Hospital, Alicante, Spain.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Middleton', 'Affiliation': 'Department of Medical Oncology, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Dane', 'Affiliation': 'Department of Medical Oncology, Marmara University Medical Faculty, Istanbul, Turkey.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Reichardt', 'Affiliation': 'Interdisciplinary Oncology, HELIOS Klinikum Berlin-Buch, Berlin, Germany.'}, {'ForeName': 'F L', 'Initials': 'FL', 'LastName': 'Pimentel', 'Affiliation': 'Oncology, Hospital de São Sebastião, Santa Maria da Feira, Portugal.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Cohn', 'Affiliation': 'US Oncology Research, Rocky Mountain Cancer Centers, Denver, USA.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Follana', 'Affiliation': 'Department of Medical Oncology, Centre Antoine Lacassagne, Nice, France.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Clemens', 'Affiliation': 'Department of Internal Medicine I, Klinikum Mutterhaus der Borromaeerinnen, Trier, Germany.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Zaniboni', 'Affiliation': 'Medical Oncology, Fondazione Poliambulanza - Istituto Ospedaliero, Brescia, Italy.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Moiseyenko', 'Affiliation': 'Medical Oncology, N.N. Petrov Oncology SRI, St Petersburg, Russia.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Harrison', 'Affiliation': 'Department of Clinical Oncology, Mount Vernon Cancer Centre, Northwood, UK.'}, {'ForeName': 'D A', 'Initials': 'DA', 'LastName': 'Richards', 'Affiliation': 'US Oncology Research, Texas Oncology-Tyler, Tyler, USA.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Prenen', 'Affiliation': 'Digestive Oncology, University Hospitals Leuven and KU Leuven, Leuven, Belgium.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Pernot', 'Affiliation': 'Digestive Oncology, Universite Paris-V European Hospital Georges Pompidou, APHP, Paris, France.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Ecstein-Fraisse', 'Affiliation': 'Medical Operations, Sanofi K.K., Tokyo, Japan.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Hitier', 'Affiliation': 'Statistics, Sanofi, Chilly-Mazarin, France.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Rougier', 'Affiliation': 'Digestive Oncology, Universite Paris-V European Hospital Georges Pompidou, APHP, Paris, France.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdu496'] 3146,25355723,Phase II randomized study of whole-brain radiation therapy with or without concurrent temozolomide for brain metastases from breast cancer.,"BACKGROUND To improve the therapeutic index of whole-brain radiation therapy (WBRT) in the treatment of brain metastases (BM) from breast cancer, we investigated the efficacy and safety of WBRT combined with temozolomide (TMZ) in this population. PATIENTS AND METHODS This phase II multicenter prospective randomized study included patients with newly diagnosed intraparenchymal BMs from breast cancer, unsuitable for surgery or radiosurgery. All patients received conformal WBRT (3 Gy × 10-30 Gy), with or without concomitant TMZ administered at a dosage of 75 mg/m(2)/day during the irradiation period. The primary end point was objective response rate (ORR) 6 weeks after the end of treatment, defined as a partial or complete response on systematic brain MRI (modified WHO criteria). Secondary end points were progression-free survival (PFS) and overall survival (OS), neurologic symptoms, and tolerability. RESULTS Between February 2008 and November 2010, 100 patients were enrolled in the study (50 in the WBRT + TMZ arm, 50 in the WBRT arm). Median age was 55 years (29-79). Median follow-up was 9.4 months [1.0-68.1]. ORRs at 6 weeks were 36% in the WBRT arm and 30% in the WBRT + TMZ arm (NS). In the WBRT arm, median PFS was 7.4 months and median OS was 11.1 months. In the WBRT + TMZ arm, median PFS was 6.9 months and median OS was 9.4 months. Treatment was well tolerated in this arm: the most common ≥grade 2 acute toxicity was reversible lymphopenia. CONCLUSION WBRT combined with TMZ did not significantly improve local control and survival in patients with BMs from breast cancer. CLINICALTRIALS.GOV: NCT00875355.",2015,ORRs at 6 weeks were 36% in the WBRT arm and 30% in the WBRT + TMZ arm (NS).,"['brain metastases from breast cancer', 'Between February 2008 and November 2010', '100 patients were enrolled in the study (50 in the WBRT + TMZ arm, 50 in the WBRT arm', 'patients with BMs from breast cancer', 'brain metastases (BM) from breast cancer', 'patients with newly diagnosed intraparenchymal BMs from breast cancer, unsuitable for surgery or radiosurgery', 'Median age was 55 years (29-79']","['whole-brain radiation therapy (WBRT', 'TMZ', 'whole-brain radiation therapy with or without concurrent temozolomide', 'WBRT + TMZ', 'WBRT combined with TMZ', 'conformal WBRT', 'WBRT combined with temozolomide (TMZ']","['ORRs', 'median PFS', 'objective response rate (ORR', 'systematic brain MRI (modified WHO criteria', 'local control and survival', 'progression-free survival (PFS) and overall survival (OS), neurologic symptoms, and tolerability']","[{'cui': 'C0220650', 'cui_str': 'Secondary malignant neoplasm of brain (disorder)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0085203', 'cui_str': 'Radiosurgery'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C1520143', 'cui_str': 'Whole brain radiation therapy (regime/therapy)'}, {'cui': 'C0205420', 'cui_str': 'Concurrent (qualifier value)'}, {'cui': 'C0076080', 'cui_str': 'temozolomide'}, {'cui': 'C0336789', 'cui_str': 'Combine'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0220922', 'cui_str': 'systematics'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0235031', 'cui_str': 'Neurologic Symptoms'}]",100.0,0.0416374,ORRs at 6 weeks were 36% in the WBRT arm and 30% in the WBRT + TMZ arm (NS).,"[{'ForeName': 'K I', 'Initials': 'KI', 'LastName': 'Cao', 'Affiliation': 'Department of Radiation Oncology.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Lebas', 'Affiliation': 'Department of Statistics.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Gerber', 'Affiliation': 'Department of Radiology, Institut Curie, Paris.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Levy', 'Affiliation': 'Department of Radiation Oncology, Centre François Baclesse, Caen.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Le Scodan', 'Affiliation': 'Department of Radiation Oncology.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Bourgier', 'Affiliation': 'Department of Radiation Oncology, Institut Gustave Roussy, Villejuif.'}, {'ForeName': 'J-Y', 'Initials': 'JY', 'LastName': 'Pierga', 'Affiliation': 'Department of Medical Oncology, Institut Curie, Paris, France.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Gobillion', 'Affiliation': 'Department of Statistics.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Savignoni', 'Affiliation': 'Department of Statistics.'}, {'ForeName': 'Y M', 'Initials': 'YM', 'LastName': 'Kirova', 'Affiliation': 'Department of Radiation Oncology. Electronic address: youlia.kirova@curie.fr.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdu488'] 3147,25361980,Translational studies within the TAMRAD randomized GINECO trial: evidence for mTORC1 activation marker as a predictive factor for everolimus efficacy in advanced breast cancer.,"BACKGROUND Everolimus is an agent frequently associated with specific toxicities. Predictive markers of efficacy are needed to help define which patients could benefit from it. The goal of this exploratory study was to identify potential predictive biomarkers in the mammalian target of rapamycin (mTOR) complex 1 (mTORC1) activation pathway using primary tumor samples collected during the phase II tamoxifen plus everolimus (TAMRAD) trial. PATIENTS AND METHODS Tumor tissues were collected retrospectively from the TAMRAD trial. Immunohistochemistry was carried out using specific antibodies directed toward proteins that result in mTORC1 activation [canonical phosphatidylinositol 3-kinase (PI3K)/protein kinase B (Akt)/mTOR or alternative pathways]. DNA was extracted from the tumor tissue; mutation screening in the PIK3CA gene (exons 9 and 20) and the KRAS gene (exons 2 and 3) was first carried out using Sanger direct sequencing, and then completed by next-generation sequencing for PIK3CA. An exploratory analysis of everolimus efficacy in terms of a time-to-progression (TTP) increase was carried out in each biomarker subgroup (high versus low expression referring to the median percentage of marked cells). RESULTS A total of 55 primary tumor samples from the TAMRAD trial—25 from the tamoxifen-alone group and 30 from the tamoxifen/everolimus group—were evaluated for biomarkers. The subgroups most likely to have an improvement in TTP with tamoxifen/everolimus therapy, compared with tamoxifen alone, were patients with high p4EBP1, low 4EBP1, low liver kinase B1, low pAkt, and low PI3K. Among the 45 samples screened for mutation status, nine samples (20%; 95% CI 9.6-34.6) had a PIK3CA mutation. KRAS mutation was observed in one patient. CONCLUSIONS A positive correlation between late effectors of mTORC1 activation, a positive correlation between Akt-independent mTORC1 activation, and an inverse correlation between canonical PI3K/Akt/mTOR pathway and everolimus efficacy were observed in this exploratory analysis. However, these correlations need to be validated in larger studies before applying the findings to routine clinical practice.",2015,"Among the 45 samples screened for mutation status, nine samples (20%; 95% CI 9.6-34.6) had a PIK3CA mutation.","['Tumor tissues were collected retrospectively from the TAMRAD trial', 'advanced breast cancer']","['PI3K)/protein kinase B (Akt)/mTOR or alternative pathways', 'tamoxifen', 'tamoxifen/everolimus']","['KRAS mutation', 'canonical PI3K/Akt/mTOR pathway and everolimus efficacy']","[{'cui': 'C0475358', 'cui_str': 'Tumor tissue sample (specimen)'}, {'cui': 'C3495917', 'cui_str': 'Advanced breast cancer'}]","[{'cui': 'C4521566', 'cui_str': 'Kinase'}, {'cui': 'C0039286', 'cui_str': 'Tamoxifen'}, {'cui': 'C0541315', 'cui_str': 'everolimus'}]","[{'cui': 'C0026882', 'cui_str': 'Mutation'}, {'cui': 'C0541315', 'cui_str': 'everolimus'}]",,0.0451108,"Among the 45 samples screened for mutation status, nine samples (20%; 95% CI 9.6-34.6) had a PIK3CA mutation.","[{'ForeName': 'I', 'Initials': 'I', 'LastName': 'Treilleux', 'Affiliation': 'Department of Anatomopathology, Centre Léon Bérard, Lyon.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Arnedos', 'Affiliation': 'Oncology Department, Gustave Roussy, Villejuif.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Cropet', 'Affiliation': 'Biostatistics and Therapeutic Evaluation Unit.'}, {'ForeName': 'Q', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': 'Genomic Platform-Translational Research Laboratory, Centre Léon Bérard, Lyon.'}, {'ForeName': 'J-M', 'Initials': 'JM', 'LastName': 'Ferrero', 'Affiliation': 'Medical Oncology Department, Centre Antoine Lacassagne, Nice.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Abadie-Lacourtoisie', 'Affiliation': 'Medical Oncology Department, Centre Paul Papin, Angers.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Levy', 'Affiliation': 'Oncology Department, Centre François Baclesse, Caen.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Legouffe', 'Affiliation': 'Hematology and Oncology Department, Clinique de Valdegour, Nimes.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Lortholary', 'Affiliation': 'Oncology Department, Centre Catherine de Sienne, Nantes.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Pujade-Lauraine', 'Affiliation': 'Oncology Department, Université Paris Descartes, AP-HP, Hôpitaux Universitaires Paris Centre, Site Hôtel-Dieu, Paris.'}, {'ForeName': 'A-V', 'Initials': 'AV', 'LastName': 'Bourcier', 'Affiliation': 'Hematology and Oncology Department, Centre Hospitalier Départemental Les Oudairies, La Roche-Sur-Yon.'}, {'ForeName': 'J-C', 'Initials': 'JC', 'LastName': 'Eymard', 'Affiliation': 'Department of Medicine, Institut Jean Godinot, Reims.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Spaeth', 'Affiliation': ""Oncology Department, Centre d'Oncologie de Gentilly, Nancy.""}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Bachelot', 'Affiliation': '2B North Department, Department of Medical Oncology and Cancer Research Center of Lyon, Centre Léon Bérard, Lyon, France. Electronic address: thomas.bachelot@lyon.unicancer.fr.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdu497'] 3148,32015461,"Double blind, two dose, randomized, placebo-controlled, cross-over clinical trial of the positive allosteric modulator at the alpha7 nicotinic cholinergic receptor AVL-3288 in schizophrenia patients.","Despite their theoretical rationale, nicotinic alpha-7 acetylcholine (nα 7 ) receptor agonists, have largely failed to demonstrate efficacy in placebo-controlled trials in schizophrenia. AVL-3288 is a nα 7 positive allosteric modulator (PAM), which is only active in the presence of the endogenous ligand (acetylcholine), and thus theoretically less likely to cause receptor desensitization. We evaluated the efficacy of AVL-3288 in a Phase 1b, randomized, double-blind, placebo-controlled, triple cross-over study. Twenty-four non-smoking, medicated, outpatients with schizophrenia or schizoaffective disorder and a Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) ≥62 were randomized. Each subject received 5 days of AVL-3288 (10, 30 mg) and placebo across three separate treatment weeks. The primary outcome measure was the RBANS total scale score, with auditory P50 evoked potential suppression the key target engagement biomarker. Secondary outcome measures include task-based fMRI (RISE task), mismatch negativity, the Scale for the Assessment of Negative Symptoms of Schizophrenia (SANS) and the Brief Psychiatric Rating Scale (BPRS). Twenty-four subjects were randomized and treated without any clinically significant treatment emergent adverse effects. Baseline RBANS (82 ± 17) and BPRS (41 ± 13) scores were consistent with moderate impairment. Primary outcomes were negative, with non-significant worsening for both active groups vs. placebo in the P50 and minimal between group changes on the RBANS. In conclusion, the results did not indicate efficacy of the compound, consistent with most prior results for the nα 7 target.",2020,"Primary outcomes were negative, with non-significant worsening for both active groups vs. placebo in the P50 and minimal between group changes on the RBANS.","['schizophrenia patients', 'Twenty-four non-smoking, medicated, outpatients with schizophrenia or schizoaffective disorder and a repeatable battery for the assessment of neuropsychological status (RBANS) ≥62 were randomized']","['placebo', 'AVL-3288']","['task-based fMRI (RISE task), mismatch negativity, the scale for the assessment of negative symptoms of schizophrenia (SANS) and the brief psychiatric rating scale (BPRS', 'RBANS total scale score, with auditory P50 evoked potential suppression the key target engagement biomarker']","[{'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C3715070', 'cui_str': '24 (qualifier value)'}, {'cui': 'C0453996', 'cui_str': 'Tobacco Smoking'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0036337', 'cui_str': 'Schizoaffective Disorder'}, {'cui': 'C4505412', 'cui_str': 'Repeatable Battery for the Assessment of Neuropsychological Status'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0449216', 'cui_str': 'aVL (body structure)'}]","[{'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0376335', 'cui_str': 'fMRI'}, {'cui': 'C0035853', 'cui_str': 'Rose'}, {'cui': 'C0222045'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0036341', 'cui_str': 'Schizophrenic Disorders'}, {'cui': 'C0029941', 'cui_str': 'Overall and Gorham Brief Psychiatric Rating Scale'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439825', 'cui_str': 'Auditory (qualifier value)'}, {'cui': 'C3850132', 'cui_str': 'P50 Wave'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression (disorder)'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}]",24.0,0.429793,"Primary outcomes were negative, with non-significant worsening for both active groups vs. placebo in the P50 and minimal between group changes on the RBANS.","[{'ForeName': 'Joshua T', 'Initials': 'JT', 'LastName': 'Kantrowitz', 'Affiliation': 'Columbia University, New York, USA. jk3380@cumc.columbia.edu.'}, {'ForeName': 'Daniel C', 'Initials': 'DC', 'LastName': 'Javitt', 'Affiliation': 'Columbia University, New York, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Freedman', 'Affiliation': 'U Colorado, Denver, CO, USA.'}, {'ForeName': 'Pejman', 'Initials': 'P', 'LastName': 'Sehatpour', 'Affiliation': 'Columbia University, New York, USA.'}, {'ForeName': 'Lawrence S', 'Initials': 'LS', 'LastName': 'Kegeles', 'Affiliation': 'Columbia University, New York, USA.'}, {'ForeName': 'Marlene', 'Initials': 'M', 'LastName': 'Carlson', 'Affiliation': 'Columbia University, New York, USA.'}, {'ForeName': 'Tarek', 'Initials': 'T', 'LastName': 'Sobeih', 'Affiliation': 'Nathan Kline Institute, Orangeburg, USA.'}, {'ForeName': 'Melanie M', 'Initials': 'MM', 'LastName': 'Wall', 'Affiliation': 'Columbia University, New York, USA.'}, {'ForeName': 'Tse-Hwei', 'Initials': 'TH', 'LastName': 'Choo', 'Affiliation': 'Columbia University, New York, USA.'}, {'ForeName': 'Blair', 'Initials': 'B', 'LastName': 'Vail', 'Affiliation': 'New York State Psychiatric Institute, New York, USA.'}, {'ForeName': 'Jack', 'Initials': 'J', 'LastName': 'Grinband', 'Affiliation': 'Columbia University, New York, USA.'}, {'ForeName': 'Jeffrey A', 'Initials': 'JA', 'LastName': 'Lieberman', 'Affiliation': 'Columbia University, New York, USA.'}]",Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology,['10.1038/s41386-020-0628-9'] 3149,25361982,Prognosis of stage II and III colon cancer treated with adjuvant 5-fluorouracil or FOLFIRI in relation to microsatellite status: results of the PETACC-3 trial.,"BACKGROUND Although colon cancer (CC) with microsatellite instability (MSI) has a more favorable prognosis than microsatellite stable (MSS) CC, the impact varies according to clinicopathological parameters. We studied how MSI status affects prognosis in a trial-based cohort of stage II and III CC patients treated with 5-fluorouracil (5-FU)/leucovorin or FOLFIRI. MATERIALS AND METHODS Tissue specimens of 1254 patients were tested for 10 different loci and were classified as MSI-high (MSI-H) when three or more loci were unstable and MSS otherwise. Study end points were overall survival (OS) and relapse-free survival (RFS). RESULTS In stage II, RFS and OS were better for patients with MSI-H than with MSS CC [hazard ratio (HR) 0.26, 95% CI 0.10-0.65, P = 0.004 and 0.16, 95% CI 0.04-0.64, P = 0.01). In stage III, RFS was slightly better for patients with MSI-H CC (HR 0.67, 95% CI 0.46-0.99, P = 0.04), but the difference was not statistically significant for OS (HR 0.70, 95% CI 0.44-1.09, P = 0.11). Outcomes for patients with MSI-H CC were not different between the two treatment arms. RFS was better for patients with MSI-H than with MSS CC in the right and left colon, whereas for OS this was significant only in the right colon. For patients with KRAS- and BRAF-mutated CC, but not for double wild-type patients, RFS and OS were significantly better when the tumors were also MSI-H. An interaction test was statistically significant for KRAS and MSI status (P = 0.005), but not for BRAF status (P = 0.14). CONCLUSIONS Our results confirm that for patients with stage II CC but less so for those with stage III MSI-H is strongly prognostic for RFS and OS. In the presence of 5-FU treatment, stage II patients with MSI-H tumors maintain their survival advantage in comparison with MSS patients and adding irinotecan has no added benefit. CLINICALTRIALS.GOV IDENTIFIER: NCT00026273.",2015,"RFS was better for patients with MSI-H than with MSS CC in the right and left colon, whereas for OS this was significant only in the right colon.","['Tissue specimens of 1254 patients were tested for 10 different loci and were classified as MSI-high (MSI-H) when three or more loci were unstable and MSS otherwise', 'patients with MSI-H CC']","['5-fluorouracil (5-FU)/leucovorin or FOLFIRI', 'adjuvant 5-fluorouracil or FOLFIRI', 'MSS CC', 'irinotecan', '5-FU']","['RFS', 'overall survival (OS) and relapse-free survival (RFS', 'survival advantage', 'KRAS and MSI status', 'RFS and OS', 'BRAF status', 'hazard ratio (HR']","[{'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0008902', 'cui_str': 'Systematics'}, {'cui': 'C4523846', 'cui_str': 'MSI-high'}, {'cui': 'C0443343', 'cui_str': 'Unstable status (qualifier value)'}]","[{'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0123931', 'cui_str': 'irinotecan'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",1254.0,0.0998433,"RFS was better for patients with MSI-H than with MSS CC in the right and left colon, whereas for OS this was significant only in the right colon.","[{'ForeName': 'D', 'Initials': 'D', 'LastName': 'Klingbiel', 'Affiliation': 'SAKK Swiss Group for Clinical Cancer Research, Coordinating Center, Bern; SIB Swiss Institute of Bioinformatics, Lausanne, Switzerland.'}, {'ForeName': 'Z', 'Initials': 'Z', 'LastName': 'Saridaki', 'Affiliation': 'Laboratory of Tumor Cell Biology School of Medicine, University of Crete, Heraklion, Greece; Center for Human Genetics O&N1, Katholieke Universiteit Leuven, Leuven, Belgium.'}, {'ForeName': 'A D', 'Initials': 'AD', 'LastName': 'Roth', 'Affiliation': 'Oncosurgery Unit, Geneva University Hospital, Geneva.'}, {'ForeName': 'F T', 'Initials': 'FT', 'LastName': 'Bosman', 'Affiliation': 'Department of Pathology, Lausanne University, Lausanne.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Delorenzi', 'Affiliation': 'SIB Swiss Institute of Bioinformatics, Lausanne, Switzerland; Ludwig Center for Cancer Research; Department of Oncology, University of Lausanne, Lausanne, Switzerland.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Tejpar', 'Affiliation': 'Center for Human Genetics O&N1, Katholieke Universiteit Leuven, Leuven, Belgium; Laboratory of Molecular Digestive Oncology, Department of Oncology, KU Leuven, Leuven, Belgium. Electronic address: sabine.tejpar@uz.kuleuven.ac.be.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdu499'] 3150,25361981,Molecular subtype and tumor characteristics of breast cancer metastases as assessed by gene expression significantly influence patient post-relapse survival.,"BACKGROUND We and others have recently shown that tumor characteristics are altered throughout tumor progression. These findings emphasize the need for re-examination of tumor characteristics at relapse and have led to recommendations from ESMO and the Swedish Breast Cancer group. Here, we aim to determine whether tumor characteristics and molecular subtypes in breast cancer metastases confer clinically relevant prognostic information for patients. PATIENTS AND METHODS The translational aspect of the Swedish multicenter randomized trial called TEX included 111 patients with at least one biopsy from a morphologically confirmed locoregional or distant breast cancer metastasis diagnosed from December 2002 until June 2007. All patients had detailed clinical information, complete follow-up, and metastasis gene expression information (Affymetrix array GPL10379). We assessed the previously published gene expression modules describing biological processes [proliferation, apoptosis, human epidermal receptor 2 (HER2) and estrogen (ER) signaling, tumor invasion, immune response, and angiogenesis] and pathways (Ras, MAPK, PTEN, AKT-MTOR, PI3KCA, IGF1, Src, Myc, E2F3, and β-catenin) and the intrinsic subtypes (PAM50). Furthermore, by contrasting genes expressed in the metastases in relation to survival, we derived a poor metastasis survival signature. RESULTS A significant reduction in post-relapse breast cancer-specific survival was associated with low-ER receptor signaling and apoptosis gene module scores, and high AKT-MTOR, Ras, and β-catenin module scores. Similarly, intrinsic subtyping of the metastases provided statistically significant post-relapse survival information with the worst survival outcome in the basal-like [hazard ratio (HR) 3.7; 95% confidence interval (CI) 1.3-10.9] and HER2-enriched (HR 4.4; 95% CI 1.5-12.8) subtypes compared with the luminal A subtype. Overall, 25% of the metastases were basal-like, 32% HER2-enriched, 10% luminal A, 28% luminal B, and 5% normal-like. CONCLUSIONS We show that tumor characteristics and molecular subtypes of breast cancer metastases significantly influence post-relapse patient survival, emphasizing that molecular investigations at relapse provide prognostic and clinically relevant information. CLINICALTRIALS.GOV: This is the translational part of the Swedish multicenter and randomized trial TEX, clinicaltrials.gov identifier nct01433614 (http://www.clinicaltrials.gov/ct2/show/nct01433614).",2015,"A significant reduction in post-relapse breast cancer-specific survival was associated with low-ER receptor signaling and apoptosis gene module scores, and high AKT-MTOR, Ras, and β-catenin module scores.","['111 patients with at least one biopsy from a morphologically confirmed locoregional or distant breast cancer metastasis diagnosed from December 2002 until June 2007', 'patients']",['TEX'],"['post-relapse breast cancer-specific survival', 'biological processes [proliferation, apoptosis, human epidermal receptor 2 (HER2) and estrogen (ER) signaling, tumor invasion, immune response, and angiogenesis']","[{'cui': 'C4517538', 'cui_str': '111 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0443203', 'cui_str': 'Distant (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0027627', 'cui_str': 'Metastasis'}]",[],"[{'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C3714634', 'cui_str': 'Biological Processes'}, {'cui': 'C0334094', 'cui_str': 'Proliferation (morphologic abnormality)'}, {'cui': 'C0162638', 'cui_str': 'Programmed Cell Death, Type I'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0597357', 'cui_str': 'Receptor (substance)'}, {'cui': 'C3537250', 'cui_str': 'ESTROGENS'}, {'cui': 'C4317086', 'cui_str': 'Tumor invasion'}, {'cui': 'C0301872', 'cui_str': 'Immune response, function (observable entity)'}]",111.0,0.338645,"A significant reduction in post-relapse breast cancer-specific survival was associated with low-ER receptor signaling and apoptosis gene module scores, and high AKT-MTOR, Ras, and β-catenin module scores.","[{'ForeName': 'N P', 'Initials': 'NP', 'LastName': 'Tobin', 'Affiliation': 'Department of Oncology and Pathology, Cancer Center Karolinska, Karolinska Institutet and University Hospital, Stockholm, Sweden.'}, {'ForeName': 'J C', 'Initials': 'JC', 'LastName': 'Harrell', 'Affiliation': 'Department of Genetics and Pathology, Lineberger Comprehensive Cancer Center, University of North Carolina-Chapel Hill, Chapel Hill, USA.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Lövrot', 'Affiliation': 'Department of Oncology and Pathology, Cancer Center Karolinska, Karolinska Institutet and University Hospital, Stockholm, Sweden.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Egyhazi Brage', 'Affiliation': 'Department of Oncology and Pathology, Cancer Center Karolinska, Karolinska Institutet and University Hospital, Stockholm, Sweden.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Frostvik Stolt', 'Affiliation': 'Department of Oncology and Pathology, Cancer Center Karolinska, Karolinska Institutet and University Hospital, Stockholm, Sweden.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Carlsson', 'Affiliation': 'Department of Oncology, Sundsvall General Hospital, Sundsvall.'}, {'ForeName': 'Z', 'Initials': 'Z', 'LastName': 'Einbeigi', 'Affiliation': 'Department of Oncology, Sahlgrenska University Hospital, Gothenburg.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Linderholm', 'Affiliation': 'Department of Oncology and Pathology, Cancer Center Karolinska, Karolinska Institutet and University Hospital, Stockholm, Sweden; Department of Oncology, Sahlgrenska University Hospital, Gothenburg.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Loman', 'Affiliation': 'Department of Oncology, Skåne University Hospital, Lund.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Malmberg', 'Affiliation': 'Department of Oncology, Skåne University Hospital, Helsingborg.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Walz', 'Affiliation': 'Department of Oncology and Pathology, Cancer Center Karolinska, Karolinska Institutet and University Hospital, Stockholm, Sweden; Division of Oncology, Department of Clinical and Experimental Medicine, Faculty of Health Sciences, Linköping University, Linköping.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Fernö', 'Affiliation': 'Department of Clinical Sciences, Division of Oncology and Pathology, Lund University, Lund, Sweden.'}, {'ForeName': 'C M', 'Initials': 'CM', 'LastName': 'Perou', 'Affiliation': 'Department of Genetics and Pathology, Lineberger Comprehensive Cancer Center, University of North Carolina-Chapel Hill, Chapel Hill, USA.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Bergh', 'Affiliation': 'Department of Oncology and Pathology, Cancer Center Karolinska, Karolinska Institutet and University Hospital, Stockholm, Sweden.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Hatschek', 'Affiliation': 'Department of Oncology and Pathology, Cancer Center Karolinska, Karolinska Institutet and University Hospital, Stockholm, Sweden.'}, {'ForeName': 'L S', 'Initials': 'LS', 'LastName': 'Lindström', 'Affiliation': 'Department of Surgery, University of California at San Francisco (UCSF), San Francisco, USA; Department of Biosciences and Nutrition, Karolinska Institutet and University Hospital, Stockholm, Sweden. Electronic address: linda.lindstrom@ki.se.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdu498'] 3151,21139020,"Clinical neurological outcome and quality of life among patients with limited small-cell cancer treated with two different doses of prophylactic cranial irradiation in the intergroup phase III trial (PCI99-01, EORTC 22003-08004, RTOG 0212 and IFCT 99-01).","BACKGROUND We recently published the results of the PCI99 randomised trial comparing the effect of a prophylactic cranial irradiation (PCI) at 25 or 36 Gy on the incidence of brain metastases (BM) in 720 patients with limited small-cell lung cancer (SCLC). As concerns about neurotoxicity were a major issue surrounding PCI, we report here midterm and long-term repeated evaluation of neurocognitive functions and quality of life (QoL). PATIENTS AND METHODS At predetermined intervals, the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 and brain module were used for self-reported patient data, whereas the EORTC-Radiation Therapy Oncology Group Late Effects Normal Tissue-Subjective, Objective, Management, Analytic scale was used for clinicians' assessment. For each scale, the unfavourable status was analysed with a logistic model including age, grade at baseline, time and PCI dose. RESULTS Over the 3 years studied, there was no significant difference between the two groups in any of the 17 selected items assessing QoL and neurological and cognitive functions. We observed in both groups a mild deterioration across time of communication deficit, weakness of legs, intellectual deficit and memory (all P < 0.005). CONCLUSION Patients should be informed of these potential adverse effects, as well as the benefit of PCI on survival and BM. PCI with a total dose of 25 Gy remains the standard of care in limited-stage SCLC.",2011,", there was no significant difference between the two groups in any of the 17 selected items assessing QoL and neurological and cognitive functions.","['720 patients with limited small-cell lung cancer (SCLC', 'patients with limited small-cell cancer']","['prophylactic cranial irradiation', 'prophylactic cranial irradiation (PCI']","['QoL and neurological and cognitive functions', 'mild deterioration across time of communication deficit, weakness of legs, intellectual deficit and memory', 'Clinical neurological outcome and quality of life', 'neurocognitive functions and quality of life (QoL', 'Cancer (EORTC']","[{'cui': 'C4517865', 'cui_str': 'Seven hundred and twenty'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0149925', 'cui_str': 'Oat Cell Lung Cancer'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}]","[{'cui': 'C0445202', 'cui_str': 'Prophylactic (qualifier value)'}, {'cui': 'C0079172', 'cui_str': 'Cranial Irradiation'}]","[{'cui': 'C0205494', 'cui_str': 'Neurologic (qualifier value)'}, {'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0427068', 'cui_str': 'Monoparesis - leg (disorder)'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}]",720.0,0.0577261,", there was no significant difference between the two groups in any of the 17 selected items assessing QoL and neurological and cognitive functions.","[{'ForeName': 'C', 'Initials': 'C', 'LastName': 'Le Péchoux', 'Affiliation': 'Radiation Oncology Department. Electronic address: lepechoux@igr.fr.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Laplanche', 'Affiliation': 'Biostatistics and Epidemiology Unit, Institut Gustave-Roussy, Villejuif, France.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Faivre-Finn', 'Affiliation': 'Department of Clinical Oncology, The Christie, Manchester, UK.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Ciuleanu', 'Affiliation': 'Medical Oncology Department, Institutul Oncologic I. Chiricuta, Cluj-Napoca, Romania.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Wanders', 'Affiliation': 'Radiation Oncology Department, MAASTRO Clinic, Maastricht, The Netherlands.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Lerouge', 'Affiliation': 'Radiation Oncology Department, Centre François Baclesse, Caen, France.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Keus', 'Affiliation': ""Radiation Oncology Department, Arnhem's Radiotherapeutisch Instituut, Arnhem, The Netherlands.""}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Hatton', 'Affiliation': 'Department of Clinical Oncology, Weston Park Hospital, Sheffield, UK.'}, {'ForeName': 'G M', 'Initials': 'GM', 'LastName': 'Videtic', 'Affiliation': 'Radiation Oncology Department, Cleveland Clinic Foundation, Cleveland, USA.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Senan', 'Affiliation': 'Radiation Oncology Department, VU University Medical Centre, Amsterdam, The Netherlands.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Wolfson', 'Affiliation': 'Radiation Oncology Department, University of Miami School of Medicine, Miami, USA.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Jones', 'Affiliation': 'Department of Clinical Oncology, Beatson Oncology Centre, Glasgow, UK.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Arriagada', 'Affiliation': 'Radiation Oncology Department, Karolinska Institutet, Stockholm, Sweden.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Quoix', 'Affiliation': 'Department of Pneumology, Hôpital Lyautey, Strasbourg, France.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Dunant', 'Affiliation': 'Biostatistics and Epidemiology Unit, Institut Gustave-Roussy, Villejuif, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdq576'] 3152,31340116,Roxadustat Treatment for Anemia in Patients Undergoing Long-Term Dialysis.,"BACKGROUND Roxadustat is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor that stimulates erythropoiesis and regulates iron metabolism. Additional data are needed regarding the effectiveness and safety of roxadustat as compared with standard therapy (epoetin alfa) for the treatment of anemia in patients undergoing dialysis. METHODS In a trial conducted in China, we randomly assigned (in a 2:1 ratio) patients who had been undergoing dialysis and erythropoiesis-stimulating agent therapy with epoetin alfa for at least 6 weeks to receive roxadustat or epoetin alfa three times per week for 26 weeks. Parenteral iron was withheld except as rescue therapy. The primary end point was the mean change in hemoglobin level from baseline to the average level during weeks 23 through 27. Noninferiority of roxadustat would be established if the lower boundary of the two-sided 95% confidence interval for the difference between the values in the roxadustat group and epoetin alfa group was greater than or equal to -1.0 g per deciliter. Patients in each group had doses adjusted to reach a hemoglobin level of 10.0 to 12.0 g per deciliter. Safety was assessed by analysis of adverse events and clinical laboratory values. RESULTS A total of 305 patients underwent randomization (204 in the roxadustat group and 101 in the epoetin alfa group), and 256 patients (162 and 94, respectively) completed the 26-week treatment period. The mean baseline hemoglobin level was 10.4 g per deciliter. Roxadustat led to a numerically greater mean (±SD) change in hemoglobin level from baseline to weeks 23 through 27 (0.7±1.1 g per deciliter) than epoetin alfa (0.5±1.0 g per deciliter) and was statistically noninferior (difference, 0.2±1.2 g per deciliter; 95% confidence interval [CI], -0.02 to 0.5). As compared with epoetin alfa, roxadustat increased the transferrin level (difference, 0.43 g per liter; 95% CI, 0.32 to 0.53), maintained the serum iron level (difference, 25 μg per deciliter; 95% CI, 17 to 33), and attenuated decreases in the transferrin saturation (difference, 4.2 percentage points; 95% CI, 1.5 to 6.9). At week 27, the decrease in total cholesterol was greater with roxadustat than with epoetin alfa (difference, -22 mg per deciliter; 95% CI, -29 to -16), as was the decrease in low-density lipoprotein cholesterol (difference, -18 mg per deciliter; 95% CI, -23 to -13). Roxadustat was associated with a mean reduction in hepcidin of 30.2 ng per milliliter (95% CI, -64.8 to -13.6), as compared with 2.3 ng per milliliter (95% CI, -51.6 to 6.2) in the epoetin alfa group. Hyperkalemia and upper respiratory infection occurred at a higher frequency in the roxadustat group, and hypertension occurred at a higher frequency in the epoetin alfa group. CONCLUSIONS Oral roxadustat was noninferior to parenteral epoetin alfa as therapy for anemia in Chinese patients undergoing dialysis. (Funded by FibroGen and FibroGen [China] Medical Technology Development; ClinicalTrials.gov number, NCT02652806.).",2019,"Roxadustat was associated with a mean reduction in hepcidin of 30.2 ng per milliliter (95% CI, -64.8 to -13.6), as compared with 2.3 ng per milliliter (95% CI, -51.6 to 6.2) in the epoetin alfa group.","['patients undergoing dialysis', 'Chinese patients undergoing dialysis', '305 patients underwent randomization (204 in the roxadustat group and 101 in the epoetin alfa group), and 256 patients (162 and 94, respectively) completed the 26-week treatment period', 'Patients Undergoing Long-Term Dialysis', '2:1 ratio) patients who had been undergoing dialysis and erythropoiesis-stimulating agent therapy with epoetin alfa for at least 6 weeks to receive']","['FibroGen and FibroGen', 'parenteral epoetin alfa', 'roxadustat or epoetin alfa', 'standard therapy (epoetin alfa']","['mean (±SD) change in hemoglobin level', 'low-density lipoprotein cholesterol', 'hemoglobin level', 'mean change in hemoglobin level', 'transferrin saturation', 'transferrin level', 'serum iron level', 'hypertension', 'adverse events and clinical laboratory values', 'total cholesterol', 'mean baseline hemoglobin level', 'Hyperkalemia and upper respiratory infection']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4551529', 'cui_str': 'Renal Dialysis'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C4517703', 'cui_str': 'Three hundred and five'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C4310578'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0357126', 'cui_str': 'Epoetin Alfa'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C1959590', 'cui_str': 'Erythropoiesis Stimulating Agents'}]","[{'cui': 'C4522267', 'cui_str': 'Parenteral (intended site)'}, {'cui': 'C0357126', 'cui_str': 'Epoetin Alfa'}, {'cui': 'C4310578'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C1277709', 'cui_str': 'Transferrin saturation index (procedure)'}, {'cui': 'C0202105', 'cui_str': 'Transferrin measurement (procedure)'}, {'cui': 'C1318312', 'cui_str': 'Serum iron measurement'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0020461', 'cui_str': 'Hyperpotassemia'}, {'cui': 'C0041912', 'cui_str': 'Upper Respiratory Infections'}]",305.0,0.306271,"Roxadustat was associated with a mean reduction in hepcidin of 30.2 ng per milliliter (95% CI, -64.8 to -13.6), as compared with 2.3 ng per milliliter (95% CI, -51.6 to 6.2) in the epoetin alfa group.","[{'ForeName': 'Nan', 'Initials': 'N', 'LastName': 'Chen', 'Affiliation': ""From the Department of Nephrology, Institute of Nephrology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine (N.C.), the Division of Nephrology, Huashan Hospital Fudan University (C.H.), and the Department of Nephrology, Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine (G.J.), Shanghai, the Institute of Nephrology, Zhong Da Hospital, Southeast University School of Medicine (B.-C.L.), the Department of Nephrology, First Affiliated Hospital (Jiangsu Province Hospital), Nanjing Medical University (C.X.), and the National Clinical Research Center of Kidney Diseases, Jinling Hospital, Nanjing University School of Medicine (Zhihong Liu), Nanjing, First Affiliated Hospital of Dalian Medical University, Dalian (H.L.), the Department of Nephrology, First Affiliated Hospital of Baotou Medical College of Inner Mongolia University of Science and Technology, Baotou (Caili Wang), the Division of Nephrology, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences (X. Liang) and the Renal Division, Nanfang Hospital, Southern Medical University, National Clinical Research Center for Kidney Disease, State Key Laboratory of Organ Failure Research (Zhengrong Liu), Guangzhou, the Department of Nephrology, Chinese Academy of Medical Sciences, Peking Union Medical College Hospital (X. Li), the Department of Nephrology, Peking University People's Hospital (L.Z.), the Renal Division, Department of Medicine, Peking University First Hospital and Institute of Nephrology, Peking University (M.Z.), and the Department of Nephrology, Chinese People's Liberation Army General Hospital, State Key Lab of Kidney Disease, National Clinical Research Center for Kidney Disease (G.-Y.C.), Beijing, the First Affiliated Hospital of Nanchang University, Nanchang (L.L.), the Department of Nephrology, Lanzhou University Second Hospital, Lanzhou (J.W.), and the Department of Nephrology, Second Hospital of Anhui Medical University, Hefei (L.H.) - all in China; and FibroGen, San Francisco (R.L., Chunrong Wang, C.L., T.N., L.S., K.-H.P.Y.).""}, {'ForeName': 'Chuanming', 'Initials': 'C', 'LastName': 'Hao', 'Affiliation': ""From the Department of Nephrology, Institute of Nephrology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine (N.C.), the Division of Nephrology, Huashan Hospital Fudan University (C.H.), and the Department of Nephrology, Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine (G.J.), Shanghai, the Institute of Nephrology, Zhong Da Hospital, Southeast University School of Medicine (B.-C.L.), the Department of Nephrology, First Affiliated Hospital (Jiangsu Province Hospital), Nanjing Medical University (C.X.), and the National Clinical Research Center of Kidney Diseases, Jinling Hospital, Nanjing University School of Medicine (Zhihong Liu), Nanjing, First Affiliated Hospital of Dalian Medical University, Dalian (H.L.), the Department of Nephrology, First Affiliated Hospital of Baotou Medical College of Inner Mongolia University of Science and Technology, Baotou (Caili Wang), the Division of Nephrology, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences (X. Liang) and the Renal Division, Nanfang Hospital, Southern Medical University, National Clinical Research Center for Kidney Disease, State Key Laboratory of Organ Failure Research (Zhengrong Liu), Guangzhou, the Department of Nephrology, Chinese Academy of Medical Sciences, Peking Union Medical College Hospital (X. Li), the Department of Nephrology, Peking University People's Hospital (L.Z.), the Renal Division, Department of Medicine, Peking University First Hospital and Institute of Nephrology, Peking University (M.Z.), and the Department of Nephrology, Chinese People's Liberation Army General Hospital, State Key Lab of Kidney Disease, National Clinical Research Center for Kidney Disease (G.-Y.C.), Beijing, the First Affiliated Hospital of Nanchang University, Nanchang (L.L.), the Department of Nephrology, Lanzhou University Second Hospital, Lanzhou (J.W.), and the Department of Nephrology, Second Hospital of Anhui Medical University, Hefei (L.H.) - all in China; and FibroGen, San Francisco (R.L., Chunrong Wang, C.L., T.N., L.S., K.-H.P.Y.).""}, {'ForeName': 'Bi-Cheng', 'Initials': 'BC', 'LastName': 'Liu', 'Affiliation': ""From the Department of Nephrology, Institute of Nephrology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine (N.C.), the Division of Nephrology, Huashan Hospital Fudan University (C.H.), and the Department of Nephrology, Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine (G.J.), Shanghai, the Institute of Nephrology, Zhong Da Hospital, Southeast University School of Medicine (B.-C.L.), the Department of Nephrology, First Affiliated Hospital (Jiangsu Province Hospital), Nanjing Medical University (C.X.), and the National Clinical Research Center of Kidney Diseases, Jinling Hospital, Nanjing University School of Medicine (Zhihong Liu), Nanjing, First Affiliated Hospital of Dalian Medical University, Dalian (H.L.), the Department of Nephrology, First Affiliated Hospital of Baotou Medical College of Inner Mongolia University of Science and Technology, Baotou (Caili Wang), the Division of Nephrology, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences (X. Liang) and the Renal Division, Nanfang Hospital, Southern Medical University, National Clinical Research Center for Kidney Disease, State Key Laboratory of Organ Failure Research (Zhengrong Liu), Guangzhou, the Department of Nephrology, Chinese Academy of Medical Sciences, Peking Union Medical College Hospital (X. Li), the Department of Nephrology, Peking University People's Hospital (L.Z.), the Renal Division, Department of Medicine, Peking University First Hospital and Institute of Nephrology, Peking University (M.Z.), and the Department of Nephrology, Chinese People's Liberation Army General Hospital, State Key Lab of Kidney Disease, National Clinical Research Center for Kidney Disease (G.-Y.C.), Beijing, the First Affiliated Hospital of Nanchang University, Nanchang (L.L.), the Department of Nephrology, Lanzhou University Second Hospital, Lanzhou (J.W.), and the Department of Nephrology, Second Hospital of Anhui Medical University, Hefei (L.H.) - all in China; and FibroGen, San Francisco (R.L., Chunrong Wang, C.L., T.N., L.S., K.-H.P.Y.).""}, {'ForeName': 'Hongli', 'Initials': 'H', 'LastName': 'Lin', 'Affiliation': ""From the Department of Nephrology, Institute of Nephrology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine (N.C.), the Division of Nephrology, Huashan Hospital Fudan University (C.H.), and the Department of Nephrology, Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine (G.J.), Shanghai, the Institute of Nephrology, Zhong Da Hospital, Southeast University School of Medicine (B.-C.L.), the Department of Nephrology, First Affiliated Hospital (Jiangsu Province Hospital), Nanjing Medical University (C.X.), and the National Clinical Research Center of Kidney Diseases, Jinling Hospital, Nanjing University School of Medicine (Zhihong Liu), Nanjing, First Affiliated Hospital of Dalian Medical University, Dalian (H.L.), the Department of Nephrology, First Affiliated Hospital of Baotou Medical College of Inner Mongolia University of Science and Technology, Baotou (Caili Wang), the Division of Nephrology, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences (X. Liang) and the Renal Division, Nanfang Hospital, Southern Medical University, National Clinical Research Center for Kidney Disease, State Key Laboratory of Organ Failure Research (Zhengrong Liu), Guangzhou, the Department of Nephrology, Chinese Academy of Medical Sciences, Peking Union Medical College Hospital (X. Li), the Department of Nephrology, Peking University People's Hospital (L.Z.), the Renal Division, Department of Medicine, Peking University First Hospital and Institute of Nephrology, Peking University (M.Z.), and the Department of Nephrology, Chinese People's Liberation Army General Hospital, State Key Lab of Kidney Disease, National Clinical Research Center for Kidney Disease (G.-Y.C.), Beijing, the First Affiliated Hospital of Nanchang University, Nanchang (L.L.), the Department of Nephrology, Lanzhou University Second Hospital, Lanzhou (J.W.), and the Department of Nephrology, Second Hospital of Anhui Medical University, Hefei (L.H.) - all in China; and FibroGen, San Francisco (R.L., Chunrong Wang, C.L., T.N., L.S., K.-H.P.Y.).""}, {'ForeName': 'Caili', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': ""From the Department of Nephrology, Institute of Nephrology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine (N.C.), the Division of Nephrology, Huashan Hospital Fudan University (C.H.), and the Department of Nephrology, Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine (G.J.), Shanghai, the Institute of Nephrology, Zhong Da Hospital, Southeast University School of Medicine (B.-C.L.), the Department of Nephrology, First Affiliated Hospital (Jiangsu Province Hospital), Nanjing Medical University (C.X.), and the National Clinical Research Center of Kidney Diseases, Jinling Hospital, Nanjing University School of Medicine (Zhihong Liu), Nanjing, First Affiliated Hospital of Dalian Medical University, Dalian (H.L.), the Department of Nephrology, First Affiliated Hospital of Baotou Medical College of Inner Mongolia University of Science and Technology, Baotou (Caili Wang), the Division of Nephrology, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences (X. Liang) and the Renal Division, Nanfang Hospital, Southern Medical University, National Clinical Research Center for Kidney Disease, State Key Laboratory of Organ Failure Research (Zhengrong Liu), Guangzhou, the Department of Nephrology, Chinese Academy of Medical Sciences, Peking Union Medical College Hospital (X. Li), the Department of Nephrology, Peking University People's Hospital (L.Z.), the Renal Division, Department of Medicine, Peking University First Hospital and Institute of Nephrology, Peking University (M.Z.), and the Department of Nephrology, Chinese People's Liberation Army General Hospital, State Key Lab of Kidney Disease, National Clinical Research Center for Kidney Disease (G.-Y.C.), Beijing, the First Affiliated Hospital of Nanchang University, Nanchang (L.L.), the Department of Nephrology, Lanzhou University Second Hospital, Lanzhou (J.W.), and the Department of Nephrology, Second Hospital of Anhui Medical University, Hefei (L.H.) - all in China; and FibroGen, San Francisco (R.L., Chunrong Wang, C.L., T.N., L.S., K.-H.P.Y.).""}, {'ForeName': 'Changying', 'Initials': 'C', 'LastName': 'Xing', 'Affiliation': ""From the Department of Nephrology, Institute of Nephrology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine (N.C.), the Division of Nephrology, Huashan Hospital Fudan University (C.H.), and the Department of Nephrology, Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine (G.J.), Shanghai, the Institute of Nephrology, Zhong Da Hospital, Southeast University School of Medicine (B.-C.L.), the Department of Nephrology, First Affiliated Hospital (Jiangsu Province Hospital), Nanjing Medical University (C.X.), and the National Clinical Research Center of Kidney Diseases, Jinling Hospital, Nanjing University School of Medicine (Zhihong Liu), Nanjing, First Affiliated Hospital of Dalian Medical University, Dalian (H.L.), the Department of Nephrology, First Affiliated Hospital of Baotou Medical College of Inner Mongolia University of Science and Technology, Baotou (Caili Wang), the Division of Nephrology, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences (X. Liang) and the Renal Division, Nanfang Hospital, Southern Medical University, National Clinical Research Center for Kidney Disease, State Key Laboratory of Organ Failure Research (Zhengrong Liu), Guangzhou, the Department of Nephrology, Chinese Academy of Medical Sciences, Peking Union Medical College Hospital (X. Li), the Department of Nephrology, Peking University People's Hospital (L.Z.), the Renal Division, Department of Medicine, Peking University First Hospital and Institute of Nephrology, Peking University (M.Z.), and the Department of Nephrology, Chinese People's Liberation Army General Hospital, State Key Lab of Kidney Disease, National Clinical Research Center for Kidney Disease (G.-Y.C.), Beijing, the First Affiliated Hospital of Nanchang University, Nanchang (L.L.), the Department of Nephrology, Lanzhou University Second Hospital, Lanzhou (J.W.), and the Department of Nephrology, Second Hospital of Anhui Medical University, Hefei (L.H.) - all in China; and FibroGen, San Francisco (R.L., Chunrong Wang, C.L., T.N., L.S., K.-H.P.Y.).""}, {'ForeName': 'Xinling', 'Initials': 'X', 'LastName': 'Liang', 'Affiliation': ""From the Department of Nephrology, Institute of Nephrology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine (N.C.), the Division of Nephrology, Huashan Hospital Fudan University (C.H.), and the Department of Nephrology, Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine (G.J.), Shanghai, the Institute of Nephrology, Zhong Da Hospital, Southeast University School of Medicine (B.-C.L.), the Department of Nephrology, First Affiliated Hospital (Jiangsu Province Hospital), Nanjing Medical University (C.X.), and the National Clinical Research Center of Kidney Diseases, Jinling Hospital, Nanjing University School of Medicine (Zhihong Liu), Nanjing, First Affiliated Hospital of Dalian Medical University, Dalian (H.L.), the Department of Nephrology, First Affiliated Hospital of Baotou Medical College of Inner Mongolia University of Science and Technology, Baotou (Caili Wang), the Division of Nephrology, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences (X. Liang) and the Renal Division, Nanfang Hospital, Southern Medical University, National Clinical Research Center for Kidney Disease, State Key Laboratory of Organ Failure Research (Zhengrong Liu), Guangzhou, the Department of Nephrology, Chinese Academy of Medical Sciences, Peking Union Medical College Hospital (X. Li), the Department of Nephrology, Peking University People's Hospital (L.Z.), the Renal Division, Department of Medicine, Peking University First Hospital and Institute of Nephrology, Peking University (M.Z.), and the Department of Nephrology, Chinese People's Liberation Army General Hospital, State Key Lab of Kidney Disease, National Clinical Research Center for Kidney Disease (G.-Y.C.), Beijing, the First Affiliated Hospital of Nanchang University, Nanchang (L.L.), the Department of Nephrology, Lanzhou University Second Hospital, Lanzhou (J.W.), and the Department of Nephrology, Second Hospital of Anhui Medical University, Hefei (L.H.) - all in China; and FibroGen, San Francisco (R.L., Chunrong Wang, C.L., T.N., L.S., K.-H.P.Y.).""}, {'ForeName': 'Gengru', 'Initials': 'G', 'LastName': 'Jiang', 'Affiliation': ""From the Department of Nephrology, Institute of Nephrology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine (N.C.), the Division of Nephrology, Huashan Hospital Fudan University (C.H.), and the Department of Nephrology, Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine (G.J.), Shanghai, the Institute of Nephrology, Zhong Da Hospital, Southeast University School of Medicine (B.-C.L.), the Department of Nephrology, First Affiliated Hospital (Jiangsu Province Hospital), Nanjing Medical University (C.X.), and the National Clinical Research Center of Kidney Diseases, Jinling Hospital, Nanjing University School of Medicine (Zhihong Liu), Nanjing, First Affiliated Hospital of Dalian Medical University, Dalian (H.L.), the Department of Nephrology, First Affiliated Hospital of Baotou Medical College of Inner Mongolia University of Science and Technology, Baotou (Caili Wang), the Division of Nephrology, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences (X. Liang) and the Renal Division, Nanfang Hospital, Southern Medical University, National Clinical Research Center for Kidney Disease, State Key Laboratory of Organ Failure Research (Zhengrong Liu), Guangzhou, the Department of Nephrology, Chinese Academy of Medical Sciences, Peking Union Medical College Hospital (X. Li), the Department of Nephrology, Peking University People's Hospital (L.Z.), the Renal Division, Department of Medicine, Peking University First Hospital and Institute of Nephrology, Peking University (M.Z.), and the Department of Nephrology, Chinese People's Liberation Army General Hospital, State Key Lab of Kidney Disease, National Clinical Research Center for Kidney Disease (G.-Y.C.), Beijing, the First Affiliated Hospital of Nanchang University, Nanchang (L.L.), the Department of Nephrology, Lanzhou University Second Hospital, Lanzhou (J.W.), and the Department of Nephrology, Second Hospital of Anhui Medical University, Hefei (L.H.) - all in China; and FibroGen, San Francisco (R.L., Chunrong Wang, C.L., T.N., L.S., K.-H.P.Y.).""}, {'ForeName': 'Zhengrong', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': ""From the Department of Nephrology, Institute of Nephrology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine (N.C.), the Division of Nephrology, Huashan Hospital Fudan University (C.H.), and the Department of Nephrology, Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine (G.J.), Shanghai, the Institute of Nephrology, Zhong Da Hospital, Southeast University School of Medicine (B.-C.L.), the Department of Nephrology, First Affiliated Hospital (Jiangsu Province Hospital), Nanjing Medical University (C.X.), and the National Clinical Research Center of Kidney Diseases, Jinling Hospital, Nanjing University School of Medicine (Zhihong Liu), Nanjing, First Affiliated Hospital of Dalian Medical University, Dalian (H.L.), the Department of Nephrology, First Affiliated Hospital of Baotou Medical College of Inner Mongolia University of Science and Technology, Baotou (Caili Wang), the Division of Nephrology, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences (X. Liang) and the Renal Division, Nanfang Hospital, Southern Medical University, National Clinical Research Center for Kidney Disease, State Key Laboratory of Organ Failure Research (Zhengrong Liu), Guangzhou, the Department of Nephrology, Chinese Academy of Medical Sciences, Peking Union Medical College Hospital (X. Li), the Department of Nephrology, Peking University People's Hospital (L.Z.), the Renal Division, Department of Medicine, Peking University First Hospital and Institute of Nephrology, Peking University (M.Z.), and the Department of Nephrology, Chinese People's Liberation Army General Hospital, State Key Lab of Kidney Disease, National Clinical Research Center for Kidney Disease (G.-Y.C.), Beijing, the First Affiliated Hospital of Nanchang University, Nanchang (L.L.), the Department of Nephrology, Lanzhou University Second Hospital, Lanzhou (J.W.), and the Department of Nephrology, Second Hospital of Anhui Medical University, Hefei (L.H.) - all in China; and FibroGen, San Francisco (R.L., Chunrong Wang, C.L., T.N., L.S., K.-H.P.Y.).""}, {'ForeName': 'Xuemei', 'Initials': 'X', 'LastName': 'Li', 'Affiliation': ""From the Department of Nephrology, Institute of Nephrology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine (N.C.), the Division of Nephrology, Huashan Hospital Fudan University (C.H.), and the Department of Nephrology, Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine (G.J.), Shanghai, the Institute of Nephrology, Zhong Da Hospital, Southeast University School of Medicine (B.-C.L.), the Department of Nephrology, First Affiliated Hospital (Jiangsu Province Hospital), Nanjing Medical University (C.X.), and the National Clinical Research Center of Kidney Diseases, Jinling Hospital, Nanjing University School of Medicine (Zhihong Liu), Nanjing, First Affiliated Hospital of Dalian Medical University, Dalian (H.L.), the Department of Nephrology, First Affiliated Hospital of Baotou Medical College of Inner Mongolia University of Science and Technology, Baotou (Caili Wang), the Division of Nephrology, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences (X. Liang) and the Renal Division, Nanfang Hospital, Southern Medical University, National Clinical Research Center for Kidney Disease, State Key Laboratory of Organ Failure Research (Zhengrong Liu), Guangzhou, the Department of Nephrology, Chinese Academy of Medical Sciences, Peking Union Medical College Hospital (X. Li), the Department of Nephrology, Peking University People's Hospital (L.Z.), the Renal Division, Department of Medicine, Peking University First Hospital and Institute of Nephrology, Peking University (M.Z.), and the Department of Nephrology, Chinese People's Liberation Army General Hospital, State Key Lab of Kidney Disease, National Clinical Research Center for Kidney Disease (G.-Y.C.), Beijing, the First Affiliated Hospital of Nanchang University, Nanchang (L.L.), the Department of Nephrology, Lanzhou University Second Hospital, Lanzhou (J.W.), and the Department of Nephrology, Second Hospital of Anhui Medical University, Hefei (L.H.) - all in China; and FibroGen, San Francisco (R.L., Chunrong Wang, C.L., T.N., L.S., K.-H.P.Y.).""}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Zuo', 'Affiliation': ""From the Department of Nephrology, Institute of Nephrology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine (N.C.), the Division of Nephrology, Huashan Hospital Fudan University (C.H.), and the Department of Nephrology, Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine (G.J.), Shanghai, the Institute of Nephrology, Zhong Da Hospital, Southeast University School of Medicine (B.-C.L.), the Department of Nephrology, First Affiliated Hospital (Jiangsu Province Hospital), Nanjing Medical University (C.X.), and the National Clinical Research Center of Kidney Diseases, Jinling Hospital, Nanjing University School of Medicine (Zhihong Liu), Nanjing, First Affiliated Hospital of Dalian Medical University, Dalian (H.L.), the Department of Nephrology, First Affiliated Hospital of Baotou Medical College of Inner Mongolia University of Science and Technology, Baotou (Caili Wang), the Division of Nephrology, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences (X. Liang) and the Renal Division, Nanfang Hospital, Southern Medical University, National Clinical Research Center for Kidney Disease, State Key Laboratory of Organ Failure Research (Zhengrong Liu), Guangzhou, the Department of Nephrology, Chinese Academy of Medical Sciences, Peking Union Medical College Hospital (X. Li), the Department of Nephrology, Peking University People's Hospital (L.Z.), the Renal Division, Department of Medicine, Peking University First Hospital and Institute of Nephrology, Peking University (M.Z.), and the Department of Nephrology, Chinese People's Liberation Army General Hospital, State Key Lab of Kidney Disease, National Clinical Research Center for Kidney Disease (G.-Y.C.), Beijing, the First Affiliated Hospital of Nanchang University, Nanchang (L.L.), the Department of Nephrology, Lanzhou University Second Hospital, Lanzhou (J.W.), and the Department of Nephrology, Second Hospital of Anhui Medical University, Hefei (L.H.) - all in China; and FibroGen, San Francisco (R.L., Chunrong Wang, C.L., T.N., L.S., K.-H.P.Y.).""}, {'ForeName': 'Laimin', 'Initials': 'L', 'LastName': 'Luo', 'Affiliation': ""From the Department of Nephrology, Institute of Nephrology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine (N.C.), the Division of Nephrology, Huashan Hospital Fudan University (C.H.), and the Department of Nephrology, Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine (G.J.), Shanghai, the Institute of Nephrology, Zhong Da Hospital, Southeast University School of Medicine (B.-C.L.), the Department of Nephrology, First Affiliated Hospital (Jiangsu Province Hospital), Nanjing Medical University (C.X.), and the National Clinical Research Center of Kidney Diseases, Jinling Hospital, Nanjing University School of Medicine (Zhihong Liu), Nanjing, First Affiliated Hospital of Dalian Medical University, Dalian (H.L.), the Department of Nephrology, First Affiliated Hospital of Baotou Medical College of Inner Mongolia University of Science and Technology, Baotou (Caili Wang), the Division of Nephrology, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences (X. Liang) and the Renal Division, Nanfang Hospital, Southern Medical University, National Clinical Research Center for Kidney Disease, State Key Laboratory of Organ Failure Research (Zhengrong Liu), Guangzhou, the Department of Nephrology, Chinese Academy of Medical Sciences, Peking Union Medical College Hospital (X. Li), the Department of Nephrology, Peking University People's Hospital (L.Z.), the Renal Division, Department of Medicine, Peking University First Hospital and Institute of Nephrology, Peking University (M.Z.), and the Department of Nephrology, Chinese People's Liberation Army General Hospital, State Key Lab of Kidney Disease, National Clinical Research Center for Kidney Disease (G.-Y.C.), Beijing, the First Affiliated Hospital of Nanchang University, Nanchang (L.L.), the Department of Nephrology, Lanzhou University Second Hospital, Lanzhou (J.W.), and the Department of Nephrology, Second Hospital of Anhui Medical University, Hefei (L.H.) - all in China; and FibroGen, San Francisco (R.L., Chunrong Wang, C.L., T.N., L.S., K.-H.P.Y.).""}, {'ForeName': 'Jianqin', 'Initials': 'J', 'LastName': 'Wang', 'Affiliation': ""From the Department of Nephrology, Institute of Nephrology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine (N.C.), the Division of Nephrology, Huashan Hospital Fudan University (C.H.), and the Department of Nephrology, Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine (G.J.), Shanghai, the Institute of Nephrology, Zhong Da Hospital, Southeast University School of Medicine (B.-C.L.), the Department of Nephrology, First Affiliated Hospital (Jiangsu Province Hospital), Nanjing Medical University (C.X.), and the National Clinical Research Center of Kidney Diseases, Jinling Hospital, Nanjing University School of Medicine (Zhihong Liu), Nanjing, First Affiliated Hospital of Dalian Medical University, Dalian (H.L.), the Department of Nephrology, First Affiliated Hospital of Baotou Medical College of Inner Mongolia University of Science and Technology, Baotou (Caili Wang), the Division of Nephrology, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences (X. Liang) and the Renal Division, Nanfang Hospital, Southern Medical University, National Clinical Research Center for Kidney Disease, State Key Laboratory of Organ Failure Research (Zhengrong Liu), Guangzhou, the Department of Nephrology, Chinese Academy of Medical Sciences, Peking Union Medical College Hospital (X. Li), the Department of Nephrology, Peking University People's Hospital (L.Z.), the Renal Division, Department of Medicine, Peking University First Hospital and Institute of Nephrology, Peking University (M.Z.), and the Department of Nephrology, Chinese People's Liberation Army General Hospital, State Key Lab of Kidney Disease, National Clinical Research Center for Kidney Disease (G.-Y.C.), Beijing, the First Affiliated Hospital of Nanchang University, Nanchang (L.L.), the Department of Nephrology, Lanzhou University Second Hospital, Lanzhou (J.W.), and the Department of Nephrology, Second Hospital of Anhui Medical University, Hefei (L.H.) - all in China; and FibroGen, San Francisco (R.L., Chunrong Wang, C.L., T.N., L.S., K.-H.P.Y.).""}, {'ForeName': 'Ming-Hui', 'Initials': 'MH', 'LastName': 'Zhao', 'Affiliation': ""From the Department of Nephrology, Institute of Nephrology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine (N.C.), the Division of Nephrology, Huashan Hospital Fudan University (C.H.), and the Department of Nephrology, Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine (G.J.), Shanghai, the Institute of Nephrology, Zhong Da Hospital, Southeast University School of Medicine (B.-C.L.), the Department of Nephrology, First Affiliated Hospital (Jiangsu Province Hospital), Nanjing Medical University (C.X.), and the National Clinical Research Center of Kidney Diseases, Jinling Hospital, Nanjing University School of Medicine (Zhihong Liu), Nanjing, First Affiliated Hospital of Dalian Medical University, Dalian (H.L.), the Department of Nephrology, First Affiliated Hospital of Baotou Medical College of Inner Mongolia University of Science and Technology, Baotou (Caili Wang), the Division of Nephrology, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences (X. Liang) and the Renal Division, Nanfang Hospital, Southern Medical University, National Clinical Research Center for Kidney Disease, State Key Laboratory of Organ Failure Research (Zhengrong Liu), Guangzhou, the Department of Nephrology, Chinese Academy of Medical Sciences, Peking Union Medical College Hospital (X. Li), the Department of Nephrology, Peking University People's Hospital (L.Z.), the Renal Division, Department of Medicine, Peking University First Hospital and Institute of Nephrology, Peking University (M.Z.), and the Department of Nephrology, Chinese People's Liberation Army General Hospital, State Key Lab of Kidney Disease, National Clinical Research Center for Kidney Disease (G.-Y.C.), Beijing, the First Affiliated Hospital of Nanchang University, Nanchang (L.L.), the Department of Nephrology, Lanzhou University Second Hospital, Lanzhou (J.W.), and the Department of Nephrology, Second Hospital of Anhui Medical University, Hefei (L.H.) - all in China; and FibroGen, San Francisco (R.L., Chunrong Wang, C.L., T.N., L.S., K.-H.P.Y.).""}, {'ForeName': 'Zhihong', 'Initials': 'Z', 'LastName': 'Liu', 'Affiliation': ""From the Department of Nephrology, Institute of Nephrology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine (N.C.), the Division of Nephrology, Huashan Hospital Fudan University (C.H.), and the Department of Nephrology, Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine (G.J.), Shanghai, the Institute of Nephrology, Zhong Da Hospital, Southeast University School of Medicine (B.-C.L.), the Department of Nephrology, First Affiliated Hospital (Jiangsu Province Hospital), Nanjing Medical University (C.X.), and the National Clinical Research Center of Kidney Diseases, Jinling Hospital, Nanjing University School of Medicine (Zhihong Liu), Nanjing, First Affiliated Hospital of Dalian Medical University, Dalian (H.L.), the Department of Nephrology, First Affiliated Hospital of Baotou Medical College of Inner Mongolia University of Science and Technology, Baotou (Caili Wang), the Division of Nephrology, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences (X. Liang) and the Renal Division, Nanfang Hospital, Southern Medical University, National Clinical Research Center for Kidney Disease, State Key Laboratory of Organ Failure Research (Zhengrong Liu), Guangzhou, the Department of Nephrology, Chinese Academy of Medical Sciences, Peking Union Medical College Hospital (X. Li), the Department of Nephrology, Peking University People's Hospital (L.Z.), the Renal Division, Department of Medicine, Peking University First Hospital and Institute of Nephrology, Peking University (M.Z.), and the Department of Nephrology, Chinese People's Liberation Army General Hospital, State Key Lab of Kidney Disease, National Clinical Research Center for Kidney Disease (G.-Y.C.), Beijing, the First Affiliated Hospital of Nanchang University, Nanchang (L.L.), the Department of Nephrology, Lanzhou University Second Hospital, Lanzhou (J.W.), and the Department of Nephrology, Second Hospital of Anhui Medical University, Hefei (L.H.) - all in China; and FibroGen, San Francisco (R.L., Chunrong Wang, C.L., T.N., L.S., K.-H.P.Y.).""}, {'ForeName': 'Guang-Yan', 'Initials': 'GY', 'LastName': 'Cai', 'Affiliation': ""From the Department of Nephrology, Institute of Nephrology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine (N.C.), the Division of Nephrology, Huashan Hospital Fudan University (C.H.), and the Department of Nephrology, Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine (G.J.), Shanghai, the Institute of Nephrology, Zhong Da Hospital, Southeast University School of Medicine (B.-C.L.), the Department of Nephrology, First Affiliated Hospital (Jiangsu Province Hospital), Nanjing Medical University (C.X.), and the National Clinical Research Center of Kidney Diseases, Jinling Hospital, Nanjing University School of Medicine (Zhihong Liu), Nanjing, First Affiliated Hospital of Dalian Medical University, Dalian (H.L.), the Department of Nephrology, First Affiliated Hospital of Baotou Medical College of Inner Mongolia University of Science and Technology, Baotou (Caili Wang), the Division of Nephrology, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences (X. Liang) and the Renal Division, Nanfang Hospital, Southern Medical University, National Clinical Research Center for Kidney Disease, State Key Laboratory of Organ Failure Research (Zhengrong Liu), Guangzhou, the Department of Nephrology, Chinese Academy of Medical Sciences, Peking Union Medical College Hospital (X. Li), the Department of Nephrology, Peking University People's Hospital (L.Z.), the Renal Division, Department of Medicine, Peking University First Hospital and Institute of Nephrology, Peking University (M.Z.), and the Department of Nephrology, Chinese People's Liberation Army General Hospital, State Key Lab of Kidney Disease, National Clinical Research Center for Kidney Disease (G.-Y.C.), Beijing, the First Affiliated Hospital of Nanchang University, Nanchang (L.L.), the Department of Nephrology, Lanzhou University Second Hospital, Lanzhou (J.W.), and the Department of Nephrology, Second Hospital of Anhui Medical University, Hefei (L.H.) - all in China; and FibroGen, San Francisco (R.L., Chunrong Wang, C.L., T.N., L.S., K.-H.P.Y.).""}, {'ForeName': 'Li', 'Initials': 'L', 'LastName': 'Hao', 'Affiliation': ""From the Department of Nephrology, Institute of Nephrology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine (N.C.), the Division of Nephrology, Huashan Hospital Fudan University (C.H.), and the Department of Nephrology, Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine (G.J.), Shanghai, the Institute of Nephrology, Zhong Da Hospital, Southeast University School of Medicine (B.-C.L.), the Department of Nephrology, First Affiliated Hospital (Jiangsu Province Hospital), Nanjing Medical University (C.X.), and the National Clinical Research Center of Kidney Diseases, Jinling Hospital, Nanjing University School of Medicine (Zhihong Liu), Nanjing, First Affiliated Hospital of Dalian Medical University, Dalian (H.L.), the Department of Nephrology, First Affiliated Hospital of Baotou Medical College of Inner Mongolia University of Science and Technology, Baotou (Caili Wang), the Division of Nephrology, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences (X. Liang) and the Renal Division, Nanfang Hospital, Southern Medical University, National Clinical Research Center for Kidney Disease, State Key Laboratory of Organ Failure Research (Zhengrong Liu), Guangzhou, the Department of Nephrology, Chinese Academy of Medical Sciences, Peking Union Medical College Hospital (X. Li), the Department of Nephrology, Peking University People's Hospital (L.Z.), the Renal Division, Department of Medicine, Peking University First Hospital and Institute of Nephrology, Peking University (M.Z.), and the Department of Nephrology, Chinese People's Liberation Army General Hospital, State Key Lab of Kidney Disease, National Clinical Research Center for Kidney Disease (G.-Y.C.), Beijing, the First Affiliated Hospital of Nanchang University, Nanchang (L.L.), the Department of Nephrology, Lanzhou University Second Hospital, Lanzhou (J.W.), and the Department of Nephrology, Second Hospital of Anhui Medical University, Hefei (L.H.) - all in China; and FibroGen, San Francisco (R.L., Chunrong Wang, C.L., T.N., L.S., K.-H.P.Y.).""}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Leong', 'Affiliation': ""From the Department of Nephrology, Institute of Nephrology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine (N.C.), the Division of Nephrology, Huashan Hospital Fudan University (C.H.), and the Department of Nephrology, Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine (G.J.), Shanghai, the Institute of Nephrology, Zhong Da Hospital, Southeast University School of Medicine (B.-C.L.), the Department of Nephrology, First Affiliated Hospital (Jiangsu Province Hospital), Nanjing Medical University (C.X.), and the National Clinical Research Center of Kidney Diseases, Jinling Hospital, Nanjing University School of Medicine (Zhihong Liu), Nanjing, First Affiliated Hospital of Dalian Medical University, Dalian (H.L.), the Department of Nephrology, First Affiliated Hospital of Baotou Medical College of Inner Mongolia University of Science and Technology, Baotou (Caili Wang), the Division of Nephrology, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences (X. Liang) and the Renal Division, Nanfang Hospital, Southern Medical University, National Clinical Research Center for Kidney Disease, State Key Laboratory of Organ Failure Research (Zhengrong Liu), Guangzhou, the Department of Nephrology, Chinese Academy of Medical Sciences, Peking Union Medical College Hospital (X. Li), the Department of Nephrology, Peking University People's Hospital (L.Z.), the Renal Division, Department of Medicine, Peking University First Hospital and Institute of Nephrology, Peking University (M.Z.), and the Department of Nephrology, Chinese People's Liberation Army General Hospital, State Key Lab of Kidney Disease, National Clinical Research Center for Kidney Disease (G.-Y.C.), Beijing, the First Affiliated Hospital of Nanchang University, Nanchang (L.L.), the Department of Nephrology, Lanzhou University Second Hospital, Lanzhou (J.W.), and the Department of Nephrology, Second Hospital of Anhui Medical University, Hefei (L.H.) - all in China; and FibroGen, San Francisco (R.L., Chunrong Wang, C.L., T.N., L.S., K.-H.P.Y.).""}, {'ForeName': 'Chunrong', 'Initials': 'C', 'LastName': 'Wang', 'Affiliation': ""From the Department of Nephrology, Institute of Nephrology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine (N.C.), the Division of Nephrology, Huashan Hospital Fudan University (C.H.), and the Department of Nephrology, Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine (G.J.), Shanghai, the Institute of Nephrology, Zhong Da Hospital, Southeast University School of Medicine (B.-C.L.), the Department of Nephrology, First Affiliated Hospital (Jiangsu Province Hospital), Nanjing Medical University (C.X.), and the National Clinical Research Center of Kidney Diseases, Jinling Hospital, Nanjing University School of Medicine (Zhihong Liu), Nanjing, First Affiliated Hospital of Dalian Medical University, Dalian (H.L.), the Department of Nephrology, First Affiliated Hospital of Baotou Medical College of Inner Mongolia University of Science and Technology, Baotou (Caili Wang), the Division of Nephrology, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences (X. Liang) and the Renal Division, Nanfang Hospital, Southern Medical University, National Clinical Research Center for Kidney Disease, State Key Laboratory of Organ Failure Research (Zhengrong Liu), Guangzhou, the Department of Nephrology, Chinese Academy of Medical Sciences, Peking Union Medical College Hospital (X. Li), the Department of Nephrology, Peking University People's Hospital (L.Z.), the Renal Division, Department of Medicine, Peking University First Hospital and Institute of Nephrology, Peking University (M.Z.), and the Department of Nephrology, Chinese People's Liberation Army General Hospital, State Key Lab of Kidney Disease, National Clinical Research Center for Kidney Disease (G.-Y.C.), Beijing, the First Affiliated Hospital of Nanchang University, Nanchang (L.L.), the Department of Nephrology, Lanzhou University Second Hospital, Lanzhou (J.W.), and the Department of Nephrology, Second Hospital of Anhui Medical University, Hefei (L.H.) - all in China; and FibroGen, San Francisco (R.L., Chunrong Wang, C.L., T.N., L.S., K.-H.P.Y.).""}, {'ForeName': 'Cameron', 'Initials': 'C', 'LastName': 'Liu', 'Affiliation': ""From the Department of Nephrology, Institute of Nephrology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine (N.C.), the Division of Nephrology, Huashan Hospital Fudan University (C.H.), and the Department of Nephrology, Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine (G.J.), Shanghai, the Institute of Nephrology, Zhong Da Hospital, Southeast University School of Medicine (B.-C.L.), the Department of Nephrology, First Affiliated Hospital (Jiangsu Province Hospital), Nanjing Medical University (C.X.), and the National Clinical Research Center of Kidney Diseases, Jinling Hospital, Nanjing University School of Medicine (Zhihong Liu), Nanjing, First Affiliated Hospital of Dalian Medical University, Dalian (H.L.), the Department of Nephrology, First Affiliated Hospital of Baotou Medical College of Inner Mongolia University of Science and Technology, Baotou (Caili Wang), the Division of Nephrology, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences (X. Liang) and the Renal Division, Nanfang Hospital, Southern Medical University, National Clinical Research Center for Kidney Disease, State Key Laboratory of Organ Failure Research (Zhengrong Liu), Guangzhou, the Department of Nephrology, Chinese Academy of Medical Sciences, Peking Union Medical College Hospital (X. Li), the Department of Nephrology, Peking University People's Hospital (L.Z.), the Renal Division, Department of Medicine, Peking University First Hospital and Institute of Nephrology, Peking University (M.Z.), and the Department of Nephrology, Chinese People's Liberation Army General Hospital, State Key Lab of Kidney Disease, National Clinical Research Center for Kidney Disease (G.-Y.C.), Beijing, the First Affiliated Hospital of Nanchang University, Nanchang (L.L.), the Department of Nephrology, Lanzhou University Second Hospital, Lanzhou (J.W.), and the Department of Nephrology, Second Hospital of Anhui Medical University, Hefei (L.H.) - all in China; and FibroGen, San Francisco (R.L., Chunrong Wang, C.L., T.N., L.S., K.-H.P.Y.).""}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Neff', 'Affiliation': ""From the Department of Nephrology, Institute of Nephrology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine (N.C.), the Division of Nephrology, Huashan Hospital Fudan University (C.H.), and the Department of Nephrology, Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine (G.J.), Shanghai, the Institute of Nephrology, Zhong Da Hospital, Southeast University School of Medicine (B.-C.L.), the Department of Nephrology, First Affiliated Hospital (Jiangsu Province Hospital), Nanjing Medical University (C.X.), and the National Clinical Research Center of Kidney Diseases, Jinling Hospital, Nanjing University School of Medicine (Zhihong Liu), Nanjing, First Affiliated Hospital of Dalian Medical University, Dalian (H.L.), the Department of Nephrology, First Affiliated Hospital of Baotou Medical College of Inner Mongolia University of Science and Technology, Baotou (Caili Wang), the Division of Nephrology, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences (X. Liang) and the Renal Division, Nanfang Hospital, Southern Medical University, National Clinical Research Center for Kidney Disease, State Key Laboratory of Organ Failure Research (Zhengrong Liu), Guangzhou, the Department of Nephrology, Chinese Academy of Medical Sciences, Peking Union Medical College Hospital (X. Li), the Department of Nephrology, Peking University People's Hospital (L.Z.), the Renal Division, Department of Medicine, Peking University First Hospital and Institute of Nephrology, Peking University (M.Z.), and the Department of Nephrology, Chinese People's Liberation Army General Hospital, State Key Lab of Kidney Disease, National Clinical Research Center for Kidney Disease (G.-Y.C.), Beijing, the First Affiliated Hospital of Nanchang University, Nanchang (L.L.), the Department of Nephrology, Lanzhou University Second Hospital, Lanzhou (J.W.), and the Department of Nephrology, Second Hospital of Anhui Medical University, Hefei (L.H.) - all in China; and FibroGen, San Francisco (R.L., Chunrong Wang, C.L., T.N., L.S., K.-H.P.Y.).""}, {'ForeName': 'Lynda', 'Initials': 'L', 'LastName': 'Szczech', 'Affiliation': ""From the Department of Nephrology, Institute of Nephrology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine (N.C.), the Division of Nephrology, Huashan Hospital Fudan University (C.H.), and the Department of Nephrology, Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine (G.J.), Shanghai, the Institute of Nephrology, Zhong Da Hospital, Southeast University School of Medicine (B.-C.L.), the Department of Nephrology, First Affiliated Hospital (Jiangsu Province Hospital), Nanjing Medical University (C.X.), and the National Clinical Research Center of Kidney Diseases, Jinling Hospital, Nanjing University School of Medicine (Zhihong Liu), Nanjing, First Affiliated Hospital of Dalian Medical University, Dalian (H.L.), the Department of Nephrology, First Affiliated Hospital of Baotou Medical College of Inner Mongolia University of Science and Technology, Baotou (Caili Wang), the Division of Nephrology, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences (X. Liang) and the Renal Division, Nanfang Hospital, Southern Medical University, National Clinical Research Center for Kidney Disease, State Key Laboratory of Organ Failure Research (Zhengrong Liu), Guangzhou, the Department of Nephrology, Chinese Academy of Medical Sciences, Peking Union Medical College Hospital (X. Li), the Department of Nephrology, Peking University People's Hospital (L.Z.), the Renal Division, Department of Medicine, Peking University First Hospital and Institute of Nephrology, Peking University (M.Z.), and the Department of Nephrology, Chinese People's Liberation Army General Hospital, State Key Lab of Kidney Disease, National Clinical Research Center for Kidney Disease (G.-Y.C.), Beijing, the First Affiliated Hospital of Nanchang University, Nanchang (L.L.), the Department of Nephrology, Lanzhou University Second Hospital, Lanzhou (J.W.), and the Department of Nephrology, Second Hospital of Anhui Medical University, Hefei (L.H.) - all in China; and FibroGen, San Francisco (R.L., Chunrong Wang, C.L., T.N., L.S., K.-H.P.Y.).""}, {'ForeName': 'Kin-Hung P', 'Initials': 'KP', 'LastName': 'Yu', 'Affiliation': ""From the Department of Nephrology, Institute of Nephrology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine (N.C.), the Division of Nephrology, Huashan Hospital Fudan University (C.H.), and the Department of Nephrology, Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine (G.J.), Shanghai, the Institute of Nephrology, Zhong Da Hospital, Southeast University School of Medicine (B.-C.L.), the Department of Nephrology, First Affiliated Hospital (Jiangsu Province Hospital), Nanjing Medical University (C.X.), and the National Clinical Research Center of Kidney Diseases, Jinling Hospital, Nanjing University School of Medicine (Zhihong Liu), Nanjing, First Affiliated Hospital of Dalian Medical University, Dalian (H.L.), the Department of Nephrology, First Affiliated Hospital of Baotou Medical College of Inner Mongolia University of Science and Technology, Baotou (Caili Wang), the Division of Nephrology, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences (X. Liang) and the Renal Division, Nanfang Hospital, Southern Medical University, National Clinical Research Center for Kidney Disease, State Key Laboratory of Organ Failure Research (Zhengrong Liu), Guangzhou, the Department of Nephrology, Chinese Academy of Medical Sciences, Peking Union Medical College Hospital (X. Li), the Department of Nephrology, Peking University People's Hospital (L.Z.), the Renal Division, Department of Medicine, Peking University First Hospital and Institute of Nephrology, Peking University (M.Z.), and the Department of Nephrology, Chinese People's Liberation Army General Hospital, State Key Lab of Kidney Disease, National Clinical Research Center for Kidney Disease (G.-Y.C.), Beijing, the First Affiliated Hospital of Nanchang University, Nanchang (L.L.), the Department of Nephrology, Lanzhou University Second Hospital, Lanzhou (J.W.), and the Department of Nephrology, Second Hospital of Anhui Medical University, Hefei (L.H.) - all in China; and FibroGen, San Francisco (R.L., Chunrong Wang, C.L., T.N., L.S., K.-H.P.Y.).""}]",The New England journal of medicine,['10.1056/NEJMoa1901713'] 3153,20643862,Trabectedin plus pegylated liposomal doxorubicin in relapsed ovarian cancer: outcomes in the partially platinum-sensitive (platinum-free interval 6-12 months) subpopulation of OVA-301 phase III randomized trial.,"BACKGROUND OVA-301 is a large randomized trial that showed superiority of trabectedin plus pegylated liposomal doxorubicin (PLD) over PLD alone in relapsed ovarian cancer. The optimal management of patients with partially platinum-sensitive relapse [6-12 months platinum-free interval (PFI)] is unclear. PATIENTS AND METHODS within OVA-301, we therefore now report on the outcomes for the 214 cases in this subgroup. RESULTS Trabectedin/PLD resulted in a 35% risk reduction of disease progression (DP) or death [hazard ratio (HR) = 0.65, 95% confidence interval (CI), 0.45-0.92; P = 0.0152; median progression-free survival (PFS) 7.4 versus 5.5 months], and a significant 41% decrease in the risk of death (HR = 0.59; 95% CI, 0.43-0.82; P = 0.0015; median survival 23.0 versus 17.1 months). The safety of trabectedin/PLD in this subset mimicked that of the overall population. Similar proportions of patients received subsequent therapy in each arm (76% versus 77%), although patients in the trabectedin/PLD arm had a slightly lower proportion of further platinum (49% versus 55%). Importantly, patients in the trabectedin/PLD arm survived significantly longer after subsequent platinum (HR = 0.63; P = 0.0357; median 13.3 versus 9.8 months). CONCLUSION This hypothesis-generating analysis demonstrates that superior benefits with trabectedin/PLD in terms of PFS and survival in the overall population appear particularly enhanced in patients with partially sensitive disease (PFI 6-12 months).",2011,"P = 0.0152; median progression-free survival (PFS) 7.4 versus 5.5 months], and a significant 41% decrease in the risk of death (HR = 0.59; 95% CI, 0.43-0.82; P = 0.0015; median survival 23.0 versus 17.1 months).","['within OVA-301', 'relapsed ovarian cancer', 'partially platinum-sensitive (platinum-free interval 6-12 months) subpopulation of OVA-301 phase III randomized trial', 'patients with partially platinum-sensitive relapse [6-12 months platinum-free interval (PFI', '214 cases in this subgroup']","['Trabectedin plus pegylated liposomal doxorubicin', 'trabectedin plus pegylated liposomal doxorubicin (PLD']","['PFS and survival', 'median progression-free survival', 'disease progression (DP) or death', 'risk of death']","[{'cui': 'C0029974', 'cui_str': 'Egg, Unfertilized'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C1140680', 'cui_str': 'Ovary Cancer'}, {'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C0332324', 'cui_str': 'Sensitive (qualifier value)'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}]","[{'cui': 'C1311070', 'cui_str': 'trabectedin'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0717726', 'cui_str': 'doxorubicin liposome'}, {'cui': 'C0044369', 'cui_str': 'Pyridinium, 1-dodecyl-4-formyl-3-hydroxy-5-(hydroxymethyl)-2-methyl-, chloride'}]","[{'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0242656', 'cui_str': 'Disease Progression'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",,0.193055,"P = 0.0152; median progression-free survival (PFS) 7.4 versus 5.5 months], and a significant 41% decrease in the risk of death (HR = 0.59; 95% CI, 0.43-0.82; P = 0.0015; median survival 23.0 versus 17.1 months).","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Poveda', 'Affiliation': 'Area of Gynecologic Oncology, Valencian Institute of Oncology, Valencia, Spain. Electronic address: apoveda@fivo.org.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Vergote', 'Affiliation': 'Division of Gynecological Oncology, Department of Obstetrics and Gynecology, University Hospital, Leuven, Belgium.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Tjulandin', 'Affiliation': 'Department of Clinical Pharmacology and Chemotherapy, Russian Cancer Research Center, Moscow, Russia.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Kong', 'Affiliation': ""Department of Obstetrics and Gynecology, Qilu Hospital, Shandong University, Ji'nan, Shandong, China.""}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Roy', 'Affiliation': 'Department of Gynecologic Oncology, University Hospital Center, Quebec, Canada.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Chan', 'Affiliation': 'Department of Clinical Oncology, Nottingham University Hospital, Nottingham, UK.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Filipczyk-Cisarz', 'Affiliation': 'Chemotherapy Department, Oncology Center, Wroclaw, Poland.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Hagberg', 'Affiliation': 'Department of Oncology, Akademiska Sjukhuset, Uppsala, Sweden.'}, {'ForeName': 'S B', 'Initials': 'SB', 'LastName': 'Kaye', 'Affiliation': 'Department of Cancer Medicine, The Royal Mardsen Hospital, Sutton, Surrey, UK.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Colombo', 'Affiliation': 'Medical Gynecologic Oncology Unit, European Institute of Oncology, Milan, Italy.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Lebedinsky', 'Affiliation': 'Clinical R&D and Medical Affairs Department, Pharma Mar, Madrid, Spain.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Parekh', 'Affiliation': 'Johnson & Johnson Pharmaceutical Research & Development, L.L.C., Raritan, NJ.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Gómez', 'Affiliation': 'Clinical R&D and Medical Affairs Department, Pharma Mar, Madrid, Spain.'}, {'ForeName': 'Y C', 'Initials': 'YC', 'LastName': 'Park', 'Affiliation': 'Johnson & Johnson Pharmaceutical Research & Development, L.L.C., Raritan, NJ.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Alfaro', 'Affiliation': 'Clinical R&D and Medical Affairs Department, Pharma Mar, Madrid, Spain.'}, {'ForeName': 'B J', 'Initials': 'BJ', 'LastName': 'Monk', 'Affiliation': 'Division of Gynecological Oncology, Department of Obstetrics and Gynecology, University of California Irvine Medical Center, Orange, CA, USA.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdq352'] 3154,20643863,Trabectedin plus pegylated liposomal doxorubicin in relapsed ovarian cancer delays third-line chemotherapy and prolongs the platinum-free interval.,"BACKGROUND OVA-301 is a large randomized trial that showed superiority of trabectedin plus pegylated liposomal doxorubicin (PLD; CentoCor Ortho Biotech Products L.P., Raritan, NJ, USA). over single-agent PLD in 672 patients with relapsed ovarian cancer, particularly in the partially platinum-sensitive subgroup [platinum-free interval (PFI) of 6-12 months]. This superiority has been suggested to be due to the differential impact of subsequent (platinum) therapy. PATIENTS AND METHODS a detailed analysis of subsequent therapies and survival outcomes in the overall population and in the subsets according to platinum sensitivity was therefore conducted. RESULTS similar proportions of patients received subsequent therapy in each arm (76% versus 77%), including further platinum-based regimens (49% versus 55%). Patients in the trabectedin/PLD arm received subsequent chemotherapy at a later time (median delay 2.5 months versus PLD arm). Overall survival from subsequent platinum was significantly prolonged in the partially platinum-sensitive disease subset (hazard ratio = 0.63; P = 0.0357). CONCLUSION the superiority of trabectedin/PLD over single-agent PLD in OVA-301 cannot be explained by differences in the extent or nature of subsequent therapies administered to these patients. On the other hand, these exploratory analyses support the hypothesis that the enhanced survival benefits in the partially platinum-sensitive subset might be due to an extended PFI leading to longer survival with subsequent platinum.",2011,"Overall survival from subsequent platinum was significantly prolonged in the partially platinum-sensitive disease subset (hazard ratio = 0.63; P = 0.0357). ","['672 patients with relapsed ovarian cancer, particularly in the partially platinum-sensitive subgroup [platinum-free interval (PFI) of 6-12 months']","['Trabectedin plus pegylated liposomal doxorubicin', 'subsequent chemotherapy', 'trabectedin plus pegylated liposomal doxorubicin']","['Overall survival', 'survival benefits']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C1140680', 'cui_str': 'Ovary Cancer'}, {'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C0332324', 'cui_str': 'Sensitive (qualifier value)'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C1311070', 'cui_str': 'trabectedin'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0717726', 'cui_str': 'doxorubicin liposome'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",672.0,0.0927883,"Overall survival from subsequent platinum was significantly prolonged in the partially platinum-sensitive disease subset (hazard ratio = 0.63; P = 0.0357). ","[{'ForeName': 'S B', 'Initials': 'SB', 'LastName': 'Kaye', 'Affiliation': 'Section of Medicine, Institute of Cancer Research, The Royal Marsden Hospital, Sutton, Surrey, UK. Electronic address: stan.kaye@rmh.nhs.uk.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Colombo', 'Affiliation': 'Medical Gynecologic Oncology Unit, European Institute of Oncology, Milan, Italy.'}, {'ForeName': 'B J', 'Initials': 'BJ', 'LastName': 'Monk', 'Affiliation': 'Division of Gynecological Oncology, Department of Obstetrics and Gynecology, University of California Irvine Medical Center, Orange, CA, USA.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Tjulandin', 'Affiliation': 'Department of Clinical Pharmacology and Chemotherapy, Russian Cancer Research Center, Moscow, Russia.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Kong', 'Affiliation': ""Department of Obstetrics and Gynecology, Qilu Hospital, Shandong University, Ji'nan, Shandong, China.""}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Roy', 'Affiliation': 'Department of Gynecologic Oncology, University Hospital Center, Quebec, Canada.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Chan', 'Affiliation': 'Department of Clinical Oncology, Nottingham University Hospital, Nottingham, UK.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Filipczyk-Cisarz', 'Affiliation': 'Chemotherapy Department, Oncology Center, Wroclaw, Poland.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Hagberg', 'Affiliation': 'Department of Oncology, Akademiska Sjukhuset, Uppsala, Sweden.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Vergote', 'Affiliation': 'Division of Gynecological Oncology, Department of Obstetrics and Gynecology, University Hospital, Leuven, Belgium.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Lebedinsky', 'Affiliation': 'Clinical R&D and Medical Affairs Department, Pharma Mar, Madrid, Spain.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Parekh', 'Affiliation': 'Johnson & Johnson Pharmaceutical Research & Development, L.L.C., Raritan, NJ, USA.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Santabárbara', 'Affiliation': 'Clinical R&D and Medical Affairs Department, Pharma Mar, Madrid, Spain.'}, {'ForeName': 'Y C', 'Initials': 'YC', 'LastName': 'Park', 'Affiliation': 'Johnson & Johnson Pharmaceutical Research & Development, L.L.C., Raritan, NJ, USA.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Nieto', 'Affiliation': 'Clinical R&D and Medical Affairs Department, Pharma Mar, Madrid, Spain.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Poveda', 'Affiliation': 'Department of Medical Oncology, Valencian Institute of Oncology, Valencia, Spain.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdq353'] 3155,25316259,Phase III study comparing oxaliplatin plus S-1 with cisplatin plus S-1 in chemotherapy-naïve patients with advanced gastric cancer.,"BACKGROUND We evaluated the efficacy and safety of S-1 plus oxaliplatin (SOX) as an alternative to cisplatin plus S-1 (CS) in first-line chemotherapy for advanced gastric cancer (AGC). PATIENTS AND METHODS In this randomized, open-label, multicenter phase III study, patients were randomly assigned to receive SOX (80-120 mg/day S-1 for 2 weeks with 100 mg/m(2) oxaliplatin on day 1, every 3 weeks) or CS (S-1 for 3 weeks with 60 mg/m(2) cisplatin on day 8, every 5 weeks). The primary end points were noninferiority in progression-free survival (PFS) and relative efficacy in overall survival (OS) for SOX using adjusted hazard ratios (HRs) with stratification factors; performance status and unresectable or recurrent (+adjuvant chemotherapy) disease. RESULTS Overall, 685 patients were randomized from January 2010 to October 2011. In per-protocol population, SOX (n = 318) was noninferior to CS (n = 324) in PFS [median, 5.5 versus 5.4 months; HR 1.004, 95% confidence interval (CI) 0.840-1.199; predefined noninferiority margin 1.30]. The median OS for SOX and CS were 14.1 and 13.1 months, respectively (HR 0.958 with 95% CI 0.803-1.142). In the intention-to-treat population (SOX, n = 339; CS, n = 337), the HRs in PFS and OS were 0.979 (95% CI 0.821-1.167) and 0.934 (95% CI 0.786-1.108), respectively. The most common ≥grade 3 adverse events (SOX versus CS) were neutropenia (19.5% versus 41.8%), anemia (15.1% versus 32.5%), hyponatremia (4.4% versus 13.4%), febrile neutropenia (0.9% versus 6.9%), and sensory neuropathy (4.7% versus 0%). CONCLUSION SOX is as effective as CS for AGC with favorable safety profile, therefore SOX can replace CS. CLINICAL TRIAL NUMBER JapicCTI-101021.",2015,"The primary end points were noninferiority in progression-free survival (PFS) and relative efficacy in overall survival (OS) for SOX using adjusted hazard ratios (HRs) with stratification factors; performance status and unresectable or recurrent (+adjuvant chemotherapy) disease. ","['685 patients were randomized from January 2010 to October 2011', 'advanced gastric cancer (AGC', 'chemotherapy-naïve patients with advanced gastric cancer']","['SOX', 'CS (S-1 for 3 weeks with 60 mg/m(2) cisplatin', 'oxaliplatin plus S-1 with cisplatin plus S-1', 'cisplatin plus S-1 (CS', 'oxaliplatin', 'S-1 plus oxaliplatin (SOX']","['HRs in PFS and OS', 'febrile neutropenia', 'median OS for SOX and CS', 'neutropenia', 'sensory neuropathy', 'noninferiority in progression-free survival (PFS) and relative efficacy in overall survival (OS) for SOX using adjusted hazard ratios (HRs) with stratification factors; performance status and unresectable or recurrent (+adjuvant chemotherapy) disease', 'anemia', 'hyponatremia']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0024623', 'cui_str': 'Cancer of Stomach'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}]","[{'cui': 'C0879262', 'cui_str': 'TS-1 cpd'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0746883', 'cui_str': 'Febrile Neutropenia'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C0151313', 'cui_str': 'Sensory neuropathy (disorder)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0020625', 'cui_str': 'Hyponatremia'}]",685.0,0.262227,"The primary end points were noninferiority in progression-free survival (PFS) and relative efficacy in overall survival (OS) for SOX using adjusted hazard ratios (HRs) with stratification factors; performance status and unresectable or recurrent (+adjuvant chemotherapy) disease. ","[{'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Yamada', 'Affiliation': 'Gastrointestinal Oncology Division, National Cancer Center Hospital, Tokyo. Electronic address: yayamada@ncc.go.jp.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Higuchi', 'Affiliation': 'Department of Gastroenterology, Kitasato University East Hospital, Sagamihara.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Nishikawa', 'Affiliation': 'Department of Surgery, Osaka General Medical Center, Osaka.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Gotoh', 'Affiliation': 'Cancer Chemotherapy Center, Osaka Medical College Hospital, Takatsuki.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Fuse', 'Affiliation': 'Division of Gastrointestinal Oncology and Digestive Endoscopy, National Cancer Center Hospital East, Kashiwa.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Sugimoto', 'Affiliation': 'Department of Clinical Oncology, Osaka Medical Center for Cancer and Cardiovascular Diseases, Osaka.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Nishina', 'Affiliation': 'Department of Gastrointestinal Medical Oncology, National Hospital Organization Shikoku Cancer Center, Matsuyama.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Amagai', 'Affiliation': 'Department of Gastroenterology, Ibaraki Prefectural Central Hospital, Kasama.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Chin', 'Affiliation': 'Department of Gastroenterology, Cancer Institute Hospital of JFCR, Tokyo.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Niwa', 'Affiliation': 'Department of Endoscopy, Aichi Cancer Center Hospital, Nagoya.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Tsuji', 'Affiliation': 'Department of Medical Oncology, Kochi Health Sciences Center, Kochi.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Imamura', 'Affiliation': 'Department of Surgery, Sakai City Hospital, Sakai.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Tsuda', 'Affiliation': 'Department of Gastroenterological Oncology, Hyogo Cancer Center, Akashi.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Yasui', 'Affiliation': 'Division of Gastrointestinal Oncology, Shizuoka Cancer Center, Sunto-gun.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Fujii', 'Affiliation': 'Division of Clinical Oncology, Jichi Medical University, Shimotsuke.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Yamaguchi', 'Affiliation': 'Division of Gastroenterology, Saitama Cancer Center, Kita-adachi-gun.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Yasui', 'Affiliation': 'Department of Medical Oncology, National Hospital Organization Kyoto Medical Center, Kyoto.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Hironaka', 'Affiliation': 'Clinical Trial Promotion Department, Chiba Cancer Center, Chiba.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Shimada', 'Affiliation': 'Department of Internal Medicine, Showa University Northern Yokohama Hospital, Yokohama.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Miwa', 'Affiliation': 'Division of Gastroenterology, Department of Internal Medicine, Hyogo College of Medicine, Nishinomiya.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Hamada', 'Affiliation': 'Faculty of Engineering, Tokyo University of Science, Tokyo.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Hyodo', 'Affiliation': 'Division of Gastroenterology, University of Tsukuba, Tsukuba, Japan.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdu472'] 3156,25319061,Abituzumab combined with cetuximab plus irinotecan versus cetuximab plus irinotecan alone for patients with KRAS wild-type metastatic colorectal cancer: the randomised phase I/II POSEIDON trial.,"BACKGROUND Integrins are involved in tumour progression and metastasis, and differentially expressed on colorectal cancer (CRC) cells. Abituzumab (EMD 525797), a humanised monoclonal antibody targeting integrin αν heterodimers, has demonstrated preclinical activity. This trial was designed to assess the tolerability of different doses of abituzumab in combination with cetuximab and irinotecan (phase I) and explore the efficacy and tolerability of the combination versus that of cetuximab and irinotecan in patients with metastatic CRC (mCRC) (phase II part). METHODS Eligible patients had KRAS (exon 2) wild-type mCRC and had received prior oxaliplatin-containing therapy. The trial comprised an initial safety run-in using abituzumab doses up to 1000 mg combined with a standard of care (SoC: cetuximab plus irinotecan) and a phase II part in which patients were randomised 1 : 1 : 1 to receive abituzumab 500 mg (arm A) or 1000 mg (arm B) every 2 weeks combined with SoC, or SoC alone (arm C). The primary end point was investigator-assessed progression-free survival (PFS). Secondary end points included overall survival (OS), response rate (RR) and tolerability. Associations between tumour integrin expression and outcomes were also assessed. RESULTS Phase I showed that abituzumab doses up to 1000 mg were well tolerated in combination with SoC. Seventy-three (arm A), 71 (arm B) and 72 (arm C) patients were randomised to the phase II part. Baseline characteristics were balanced. PFS was similar in the three arms: arm A versus SoC, hazard ratio (HR) 1.13 [95% confidence interval (CI) 0.78-1.64]; arm B versus SoC, HR 1.11 (95% CI 0.77-1.61). RRs were also similar. A trend toward improved OS was observed: arm A versus SoC, HR 0.83 (95% CI 0.54-1.28); arm B versus SoC, HR 0.80 (95% CI 0.52-1.25). Grade ≥3 treatment-emergent adverse events were observed in 72%, 78% and 67% of patients. High tumour integrin αvβ6 expression was associated with longer OS in arms A [HR 0.55 (0.30-1.00)] and B [HR 0.41 (0.21-0.81)] than in arm C. CONCLUSION The primary PFS end point was not met, although predefined exploratory biomarker analyses identified subgroups of patients in whom abituzumab may have benefit. The tolerability of abituzumab combined with cetuximab and irinotecan was acceptable. Further study is warranted. CLINICALTRIALS.GOV IDENTIFIER: NCT01008475.",2015,"High tumour integrin αvβ6 expression was associated with longer OS in arms A [HR 0.55 (0.30-1.00)] and B [HR 0.41 (0.21-0.81)] than in arm C. CONCLUSION ","['patients with KRAS wild-type metastatic colorectal cancer', 'patients with metastatic CRC (mCRC) (phase II part', 'Eligible patients had KRAS (exon 2) wild-type mCRC and had received prior']","['abituzumab doses up to 1000 mg combined with a standard of care (SoC: cetuximab plus irinotecan', 'Abituzumab combined with cetuximab plus irinotecan versus cetuximab plus irinotecan alone', 'abituzumab combined with cetuximab and irinotecan', 'abituzumab', 'cetuximab and irinotecan', 'abituzumab 500 mg (arm A) or 1000 mg (arm B) every 2 weeks combined with SoC, or SoC alone', 'oxaliplatin-containing therapy']","['tolerability', 'overall survival (OS), response rate (RR) and tolerability', 'investigator-assessed progression-free survival (PFS', 'PFS', 'Grade ≥3 treatment-emergent adverse events', 'OS', 'efficacy and tolerability', 'High tumour integrin αvβ6 expression', 'SoC, hazard ratio (HR']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0445392', 'cui_str': 'Wild (qualifier value)'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0346973', 'cui_str': 'Secondary malignant neoplasm of large intestine'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0170127', 'cui_str': 'Calcibiotic Root Canal Sealer'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0015295', 'cui_str': 'Exons'}]","[{'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C1883310', 'cui_str': '1000 (qualifier value)'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C2936643', 'cui_str': 'Standard of Care'}, {'cui': 'C0995188', 'cui_str': 'cetuximab'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0123931', 'cui_str': 'irinotecan'}, {'cui': 'C3816747', 'cui_str': 'Five hundred'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0035173', 'cui_str': 'Investigators'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0021701', 'cui_str': 'Integrins'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",,0.0880563,"High tumour integrin αvβ6 expression was associated with longer OS in arms A [HR 0.55 (0.30-1.00)] and B [HR 0.41 (0.21-0.81)] than in arm C. CONCLUSION ","[{'ForeName': 'E', 'Initials': 'E', 'LastName': 'Élez', 'Affiliation': ""Vall d'Hebron University Hospital and Institute of Oncology (VHIO), Universitat Autònoma de Barcelona, Barcelona, Spain.""}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Kocáková', 'Affiliation': 'Department of Comprehensive Cancer Care, Masarykuv Onkologicky Ustav, Brno, Czech Republic.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Höhler', 'Affiliation': 'Medical Clinic I, Prosper-Hospital, Recklinghausen.'}, {'ForeName': 'U M', 'Initials': 'UM', 'LastName': 'Martens', 'Affiliation': 'Department of Hematology/Oncology, Cancer Center Heilbronn-Franken, Heilbronn.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Bokemeyer', 'Affiliation': 'Department of Oncology/Hematology, University Hospital Hamburg, Hamburg, Germany.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Van Cutsem', 'Affiliation': 'Department of Digestive Oncology, University Hospital Gasthuisberg Leuven and KULeuven, Leuven, Belgium.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Melichar', 'Affiliation': 'Department of Oncology, Palacký University Medical School and Teaching Hospital, Olomouc.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Smakal', 'Affiliation': 'Department of Oncology, Horovice, Czech Republic.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Csőszi', 'Affiliation': 'Department of Oncology, Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rendelointezet, Szolnok, Hungary.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Topuzov', 'Affiliation': 'GOU VPO St-Petersburg SMA, n/a Mechnikov Federal Agency of Healthcare, St Petersburg.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Orlova', 'Affiliation': 'City Clinical Oncology Dispensary, St Petersburg.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Tjulandin', 'Affiliation': 'S.I. Russian Cancer Research Center, Moscow, Russia.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Rivera', 'Affiliation': 'University Hospital Marques de Valdecilla, Santander, Spain.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Straub', 'Affiliation': 'Merck KGaA, Darmstadt, Germany.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Bruns', 'Affiliation': 'Merck KGaA, Darmstadt, Germany.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Quaratino', 'Affiliation': 'Merck KGaA, Darmstadt, Germany.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Tabernero', 'Affiliation': ""Vall d'Hebron University Hospital and Institute of Oncology (VHIO), Universitat Autònoma de Barcelona, Barcelona, Spain. Electronic address: jtabernero@vhio.net.""}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdu474'] 3157,21282282,Differential efficacy of three cycles of CMF followed by tamoxifen in patients with ER-positive and ER-negative tumors: long-term follow up on IBCSG Trial IX.,"BACKGROUND The benefit of adjuvant chemotherapy in postmenopausal patients with estrogen receptor (ER)-positive lymph node-negative breast cancer is being reassessed. PATIENTS AND METHODS After stratification by ER status, 1669 postmenopausal patients with operable lymph node-negative breast cancer were randomly assigned to three 28-day courses of 'classical' CMF (cyclophosphamide, methotrexate, 5-fluorouracil) chemotherapy followed by tamoxifen for 57 months (CMF→tamoxifen) or to tamoxifen alone for 5 years. RESULTS ERs were positive in 81% of tumors. At a median follow-up of 13.1 years, patients with ER-positive breast cancers did not benefit from CMF [13-year disease-free survival (DFS) 64% CMF→tamoxifen, 66% tamoxifen; P = 0.99], whereas CMF substantially improved the prognosis of patients with ER-negative breast cancer (13-year DFS 73% versus 57%, P = 0.001). Similarly, breast cancer-free interval (BCFI) was identical in the ER-positive cohort but significantly improved by chemotherapy in the ER-negative cohort (13-year BCFI 80% versus 63%, P = 0.001). CMF had no influence on second nonbreast malignancies or deaths from other causes. CONCLUSION CMF is not beneficial in postmenopausal patients with node-negative ER-positive breast cancer but is highly effective within the ER-negative cohort. In the future, other markers of chemotherapy response may define a subset of patients with ER-positive tumors who may benefit from adjuvant chemotherapy.",2011,"(13-year DFS 73% versus 57%, P = 0.001).","['patients with ER-negative breast cancer', 'postmenopausal patients with node-negative ER-positive breast cancer', 'patients with ER-positive tumors who may benefit from adjuvant chemotherapy', '1669 postmenopausal patients with operable lymph node-negative breast cancer', 'patients with ER-positive and ER-negative tumors', 'postmenopausal patients with estrogen receptor (ER)-positive lymph node-negative breast cancer']","['CMF', 'adjuvant chemotherapy', ""classical' CMF (cyclophosphamide, methotrexate, 5-fluorouracil) chemotherapy followed by tamoxifen for 57 months (CMF→tamoxifen) or to tamoxifen alone"", 'tamoxifen']","['breast cancer-free interval (BCFI', 'CMF [13-year disease-free survival (DFS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0205188', 'cui_str': 'Operable (qualifier value)'}, {'cui': 'C0024204', 'cui_str': 'Lymphatic gland'}, {'cui': 'C0034804', 'cui_str': 'Estrogen Receptors'}]","[{'cui': 'C0768190', 'cui_str': 'CMF (protein)'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0443177', 'cui_str': 'Classical (qualifier value)'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0039286', 'cui_str': 'Tamoxifen'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0768190', 'cui_str': 'CMF (protein)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}]",1669.0,0.107085,"(13-year DFS 73% versus 57%, P = 0.001).","[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Aebi', 'Affiliation': 'Division of Medical Oncology, Berne University Hospital and Swiss Group for Clinical Cancer research (SAKK), Berne, Switzerland. Electronic address: stefan.aebi@onkologie.ch.'}, {'ForeName': 'Z', 'Initials': 'Z', 'LastName': 'Sun', 'Affiliation': 'IBCSG Statistical Center, Department of Biostatistics and Computational Biology, Dana-Farber Cancer Institute, Harvard School of Public Health, Boston.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Braun', 'Affiliation': 'IBCSG Statistical Center, Department of Biostatistics and Computational Biology, Dana-Farber Cancer Institute, Harvard School of Public Health, Boston.'}, {'ForeName': 'K N', 'Initials': 'KN', 'LastName': 'Price', 'Affiliation': 'IBCSG Statistical Center and Frontier Science and Technology Research Foundation, Boston, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Castiglione-Gertsch', 'Affiliation': 'Medical Onco-Gynecology Unit, Department of Medicine, Geneva University Hospital, Geneva.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Rabaglio', 'Affiliation': 'IBCSG Coordinating Center and Inselspital, Berne, Switzerland.'}, {'ForeName': 'R D', 'Initials': 'RD', 'LastName': 'Gelber', 'Affiliation': 'IBCSG Statistical Center, Department of Biostatistics and Computational Biology, Dana-Farber Cancer Institute, Frontier Science and Technology Research Foundation, Harvard School of Public Health, Harvard Medical School, Boston, USA.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Crivellari', 'Affiliation': 'Department of Medical Oncology, Centro di Riferimento Oncologico, Aviano, Italy.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Lindtner', 'Affiliation': 'Department of Surgical Oncology, Institute of Oncology, Ljulbljana, Slovenia.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Snyder', 'Affiliation': ""Department of Medical Oncology, St Vincent's Hospital, Melbourne, Australia.""}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Karlsson', 'Affiliation': 'Department of Oncology, Institute of Clinical Sciences, Sahlgrenska Academy at University of Gothenburg, Sahlgrenska University Hospital, Gothenburg, Sweden.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Simoncini', 'Affiliation': 'Department of Medical Oncology, Spedali Civili di Brescia, Brescia, Italy.'}, {'ForeName': 'B A', 'Initials': 'BA', 'LastName': 'Gusterson', 'Affiliation': 'IBCSG Pathology Review Office, Institute of Cancer Sciences, University of Glasgow, Glasgow, UK.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Viale', 'Affiliation': 'IBCSG Pathology Office, Division of Pathology and Laboratory Medicine, European Institute of Oncology, University of Milan, Milan, Italy.'}, {'ForeName': 'M M', 'Initials': 'MM', 'LastName': 'Regan', 'Affiliation': 'IBCSG Statistical Center, Department of Biostatistics and Computational Biology, Dana-Farber Cancer Institute, Harvard School of Public Health, Boston.'}, {'ForeName': 'A S', 'Initials': 'AS', 'LastName': 'Coates', 'Affiliation': 'International Breast Cancer Study Group, Berne, Switzerland; School of Public Health, University of Sydney, Australia.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Goldhirsch', 'Affiliation': 'Department of Medicine, European Institute of Oncology, Milan, Italy; Department of Medical Oncology, Oncology Institute of Southern Switzerland, Bellinzona, Switzerland.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdq754'] 3158,21285132,Very high quantitative tumor HER2 content and outcome in early breast cancer.,"BACKGROUND It is unknown how a very high tumor total HER2 (human epidermal growth factor receptor-2) content (H2T) influences outcome in early breast cancer treated with adjuvant trastuzumab plus chemotherapy. PATIENTS AND METHODS H2T was measured using a novel quantitative assay (HERmark(®)) from formalin-fixed tumor tissue of 899 women who participated in the FinHer trial (ISRCTN76560285). In a chromogenic in situ hybridization (CISH) test, 197 (21.9%) patients had HER2-positive cancer and were randomly assigned to receive trastuzumab or control. RESULTS Cancer H2T levels varied 1808-fold. High H2T levels were correlated with a positive HER2 status by CISH (P < 0.0001). A nonlinear association was present between H2T and the hazard of distant recurrence in a subpopulation treatment effect pattern plot analysis in CISH-positive disease. Patients with very high H2T (defined by ≥22-fold the median of HER2-negative cancers; 13% of CISH-positive cancers) did not benefit from adjuvant trastuzumab [hazard ratio (HR) 1.23; 95% confidence interval (CI) 0.33-4.62; P = 0.75], whereas the rest of the patients with HER2-positive disease by CISH (87%) did benefit (HR 0.52; 95% CI 0.28-1.00; P = 0.050). CONCLUSION Patients with HER2-positive breast cancer with very high tumor HER2 content may benefit less from adjuvant trastuzumab compared with those whose cancer has more moderate HER2 content.",2011,High H2T levels were correlated with a positive HER2 status by CISH (P < 0.0001).,"['Patients with HER2-positive breast cancer', 'H2T was measured using a novel quantitative assay (HERmark(®)) from formalin-fixed tumor tissue of 899 women who participated in the FinHer trial (ISRCTN76560285', 'early breast cancer', 'early breast cancer treated with adjuvant trastuzumab plus chemotherapy', '197 (21.9%) patients had HER2-positive cancer']","['trastuzumab or control', 'trastuzumab']","['High H2T levels', 'positive HER2 status by CISH']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0392762', 'cui_str': 'Quantitative (qualifier value)'}, {'cui': 'C1510438', 'cui_str': 'Assay technique (qualifier value)'}, {'cui': 'C0949307', 'cui_str': 'Formalin'}, {'cui': 'C0443218', 'cui_str': 'Fixed (qualifier value)'}, {'cui': 'C0475358', 'cui_str': 'Tumor tissue sample (specimen)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}]","[{'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}]",899.0,0.0584912,High H2T levels were correlated with a positive HER2 status by CISH (P < 0.0001).,"[{'ForeName': 'H', 'Initials': 'H', 'LastName': 'Joensuu', 'Affiliation': 'Department of Oncology, Helsinki University Central Hospital and University of Helsinki, Helsinki, Finland. Electronic address: heikki.joensuu@hus.fi.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Sperinde', 'Affiliation': 'Division of Research and Development, Monogram Biosciences, Inc., South San Francisco, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Leinonen', 'Affiliation': '4Pharma, Turku, Finland.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Huang', 'Affiliation': 'Division of Clinical Research, Monogram Biosciences, Inc., South San Francisco, USA.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Weidler', 'Affiliation': 'Division of Clinical Research, Monogram Biosciences, Inc., South San Francisco, USA.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Bono', 'Affiliation': 'Department of Oncology, Helsinki University Central Hospital and University of Helsinki, Helsinki, Finland.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Kataja', 'Affiliation': 'Department of Oncology, Kuopio University Hospital, Kuopio, and Vaasa Central Hospital, Vaasa.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Kokko', 'Affiliation': 'Department of Oncology, Kanta-Häme Central Hospital, Hämeenlinna.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Turpeenniemi-Hujanen', 'Affiliation': 'Department of Oncology and Radiotherapy, Oulu University Hospital, Oulu.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Jyrkkiö', 'Affiliation': 'Department of Oncology, Turku University Central Hospital, Turku.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Isola', 'Affiliation': 'Laboratory of Cancer Biology, Institute of Medical Technology, University of Tampere and Tampere University Hospital.'}, {'ForeName': 'P-L', 'Initials': 'PL', 'LastName': 'Kellokumpu-Lehtinen', 'Affiliation': 'Department of Oncology, Tampere University Hospital, Tampere, Finland.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Paquet', 'Affiliation': 'Division of Clinical Research, Monogram Biosciences, Inc., South San Francisco, USA.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Lie', 'Affiliation': 'Division of Clinical Research, Monogram Biosciences, Inc., South San Francisco, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Bates', 'Affiliation': 'Division of Clinical Research, Monogram Biosciences, Inc., South San Francisco, USA.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdq710'] 3159,21285135,Usefulness of a bidirectional e-learning material for explaining surgical anesthesia to cancer patients.,"BACKGROUND We developed an e-learning system, which is based on an interactive animation video that assists anesthesiologists in preanesthetic interviews. MATERIALS AND METHODS First, the feasibility of the system was investigated in 18 anesthesiologists and 95 volunteers from the general public. Content/quantity, operability, and satisfaction were assessed with a five-point scale. Secondly, a randomized controlled trial was conducted on 211 cancer patients who were scheduled to undergo general anesthesia. They were divided into an e-learning group (n = 106) and a control group (n = 105). The patients in the e-learning group watched the interactive animation before a preanesthetic interview by an anesthesiologist. RESULTS In 10 of the 11 items for content/quantity, operability, and satisfaction, the average score for both anesthesiologists and volunteers was ≥3.0 in feasibility study. Then, the level of patient comprehension of preoperative rounds and postoperative complications in the e-learning group was significantly higher than that in the control group (mean: 4.4 ± 0.5 versus 4.1 ± 0.7, P = 0.003, and 4.3 ± 0.5 versus 4.2 ± 0.5, P = 0.02); however, no significant difference in anxiety was seen between the two groups. Patient satisfaction in the e-learning group was significantly higher (mean: 4.3 ± 0.5 versus 4.0 ± 0.6, P = 0.002). CONCLUSION The e-learning system is an effective supplementary tool for preanesthetic interviews in cancer patients.",2011,"Patient satisfaction in the e-learning group was significantly higher (mean: 4.3 ± 0.5 versus 4.0 ± 0.6, P = 0.002). ","['211 cancer patients who were scheduled to undergo general anesthesia', '18 anesthesiologists and 95 volunteers from the general public', 'cancer patients']",['bidirectional e-learning material'],"['Patient satisfaction', 'anxiety', 'Content/quantity, operability, and satisfaction', 'content/quantity, operability, and satisfaction', 'level of patient comprehension of preoperative rounds and postoperative complications']","[{'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0086960', 'cui_str': 'Schedules'}, {'cui': 'C0002915', 'cui_str': 'General Anesthesia'}, {'cui': 'C0334910', 'cui_str': 'Anesthesiologist'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}]","[{'cui': 'C0520510', 'cui_str': 'Material (attribute)'}]","[{'cui': 'C0030702', 'cui_str': 'Patient Satisfaction'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C1265611', 'cui_str': 'Quantity finding'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0162340', 'cui_str': 'Understanding'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}]",211.0,0.0352371,"Patient satisfaction in the e-learning group was significantly higher (mean: 4.3 ± 0.5 versus 4.0 ± 0.6, P = 0.002). ","[{'ForeName': 'H', 'Initials': 'H', 'LastName': 'Narimatsu', 'Affiliation': 'Advanced Molecular Epidemiology Research Institute, Faculty of Medicine, Yamagata University, Yamagata. Electronic address: hiroto-narimatsu@umin.net.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Kakinuma', 'Affiliation': 'Department of Anesthesia, Teikyo University School of Medicine, Tokyo.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Sawa', 'Affiliation': 'Department of Anesthesia, Teikyo University School of Medicine, Tokyo.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Komatsu', 'Affiliation': 'The 3rd Department of Medicine, Teikyo University School of Medicine, Ichihara Hospital, Chiba.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Matsumura', 'Affiliation': 'Division of Social Communication System for Advanced Clinical Research, The Institute of Medical Science, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Kami', 'Affiliation': 'Division of Social Communication System for Advanced Clinical Research, The Institute of Medical Science, The University of Tokyo, Tokyo, Japan.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Nakata', 'Affiliation': 'Department of Anesthesia, Teikyo University School of Medicine, Tokyo.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdq718'] 3160,25355722,"Trastuzumab emtansine (T-DM1) versus lapatinib plus capecitabine in patients with HER2-positive metastatic breast cancer and central nervous system metastases: a retrospective, exploratory analysis in EMILIA.","BACKGROUND We characterized the incidence of central nervous system (CNS) metastases after treatment with trastuzumab emtansine (T-DM1) versus capecitabine-lapatinib (XL), and treatment efficacy among patients with pre-existing CNS metastases in the phase III EMILIA study. PATIENTS AND METHODS In EMILIA, patients with human epidermal growth factor receptor 2 (HER2)-positive advanced breast cancer previously treated with trastuzumab and a taxane were randomized to T-DM1 or XL until disease progression. Patients with treated, asymptomatic CNS metastases at baseline and patients developing postbaseline CNS metastases were identified retrospectively by independent review; exploratory analyses were carried out. RESULTS Among 991 randomized patients (T-DM1 = 495; XL = 496), 95 (T-DM1 = 45; XL = 50) had CNS metastases at baseline. CNS progression occurred in 9 of 450 (2.0%) and 3 of 446 (0.7%) patients without CNS metastases at baseline in the T-DM1 and XL arms, respectively, and in 10 of 45 (22.2%) and 8 of 50 (16.0%) patients with CNS metastases at baseline. Among patients with CNS metastases at baseline, a significant improvement in overall survival (OS) was observed in the T-DM1 arm compared with the XL arm [hazard ratio (HR) = 0.38; P = 0.008; median, 26.8 versus 12.9 months]. Progression-free survival by independent review was similar in the two treatment arms (HR = 1.00; P = 1.000; median, 5.9 versus 5.7 months). Multivariate analyses demonstrated similar results. Grade ≥3 adverse events were reported in 48.8% and 63.3% of patients with CNS metastases at baseline administered T-DM1 and XL, respectively; no new safety signals were observed. CONCLUSION In this retrospective, exploratory analysis, the rate of CNS progression in patients with HER2-positive advanced breast cancer was similar for T-DM1 and for XL, and higher overall in patients with CNS metastases at baseline compared with those without CNS metastases at baseline. In patients with treated, asymptomatic CNS metastases at baseline, T-DM1 was associated with significantly improved OS compared with XL.",2015,"Progression-free survival by independent review was similar in the two treatment arms (HR = 1.00; P = 1.000; median, 5.9 versus 5.7 months).","['patients with HER2-positive metastatic breast cancer and central nervous system metastases', 'patients with HER2-positive advanced breast cancer', 'Patients with treated, asymptomatic CNS metastases at baseline and patients developing postbaseline CNS metastases', 'patients with pre-existing CNS metastases in the phase III EMILIA study', 'patients with human epidermal growth factor receptor 2 (HER2)-positive advanced breast cancer previously treated with', '991 randomized patients (T-DM1 = 495; XL = 496']","['Trastuzumab emtansine (T-DM1) versus lapatinib plus capecitabine', 'trastuzumab emtansine (T-DM1) versus capecitabine-lapatinib (XL', 'trastuzumab and a taxane']","['CNS metastases', 'Progression-free survival', 'overall survival (OS', 'Grade ≥3 adverse events', 'rate of CNS progression', 'CNS progression']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4721209', 'cui_str': 'Metastasis from human epidermal growth factor 2 positive carcinoma of breast'}, {'cui': 'C0279130', 'cui_str': 'CNS metastases'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C3495917', 'cui_str': 'Advanced breast cancer'}, {'cui': 'C0231221', 'cui_str': 'Asymptomatic (finding)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C3496586', 'cui_str': 'epidermal growth factor receptor 2, human'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}]","[{'cui': 'C2935436', 'cui_str': 'ado-trastuzumab emtansine'}, {'cui': 'C1506770', 'cui_str': 'lapatinib'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C0728747', 'cui_str': 'trastuzumab'}, {'cui': 'C0796419', 'cui_str': 'Taxanes'}]","[{'cui': 'C0279130', 'cui_str': 'CNS metastases'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}]",991.0,0.13254,"Progression-free survival by independent review was similar in the two treatment arms (HR = 1.00; P = 1.000; median, 5.9 versus 5.7 months).","[{'ForeName': 'I E', 'Initials': 'IE', 'LastName': 'Krop', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute, Boston. Electronic address: ikrop@partners.org.'}, {'ForeName': 'N U', 'Initials': 'NU', 'LastName': 'Lin', 'Affiliation': 'Department of Medical Oncology, Dana-Farber Cancer Institute, Boston.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Blackwell', 'Affiliation': 'Department of Medicine, Duke University Medical Center, Durham.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Guardino', 'Affiliation': 'Product Development, Oncology, Genentech, Inc., South San Francisco, USA.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Huober', 'Affiliation': 'Department of Medical Oncology and Breast Centre, Cantonal Hospital, St Gallen, Switzerland.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Lu', 'Affiliation': 'Product Development, Oncology, Genentech, Inc., South San Francisco, USA.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Miles', 'Affiliation': 'Department of Medical Oncology, Mount Vernon Cancer Centre, Northwood, UK.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Samant', 'Affiliation': 'Biostatistics, Genentech, Inc., South San Francisco, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Welslau', 'Affiliation': 'Hematology, Medical Office, Aschaffenburg, Germany.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Diéras', 'Affiliation': 'Department of Medical Oncology, Institut Curie, Paris, France.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdu486'] 3161,21048039,Evaluation of EGFR gene copy number as a predictive biomarker for the efficacy of cetuximab in combination with chemotherapy in the first-line treatment of recurrent and/or metastatic squamous cell carcinoma of the head and neck: EXTREME study.,"BACKGROUND The phase III EXTREME study demonstrated that combining cetuximab with platinum/5-fluorouracil (5-FU) significantly improved overall survival in the first-line treatment of patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck (R/M SCCHN) compared with platinum/5-FU alone. The aim of this investigation was to evaluate elevated tumor EGFR gene copy number as a predictive biomarker in EXTREME study patients. PATIENTS AND METHODS Dual-color FISH was used to determine absolute and relative EGFR copy number. Models of differing stringencies were used to score and investigate whether increased copy number was predictive for the activity of cetuximab plus platinum/5-FU. RESULTS Tumors from 312 of 442 patients (71%) were evaluable by FISH and met the criteria for statistical analysis. A moderate increase in EGFR copy number was common, with high-level amplification of the gene occurring in a small fraction of tumors (∼11%). Considering each of the models tested, no association of EGFR copy number with overall survival, progression-free survival or best overall response was found for patients treated with cetuximab plus platinum/5-FU. CONCLUSION Tumor EGFR copy number is not a predictive biomarker for the efficacy of cetuximab plus platinum/5-FU as first-line therapy for patients with R/M SCCHN.",2011,"Considering each of the models tested, no association of EGFR copy number with overall survival, progression-free survival or best overall response was found for patients treated with cetuximab plus platinum/5-FU. CONCLUSION Tumor EGFR copy number is not a predictive biomarker for the efficacy of cetuximab plus platinum/5-FU as first-line therapy for patients with R/M SCCHN.","['study patients', 'recurrent and/or metastatic squamous cell carcinoma of the head and neck', 'patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck (R/M SCCHN', 'patients with R/M SCCHN']","['cetuximab with platinum/5-fluorouracil (5-FU', 'cetuximab', 'cetuximab plus platinum/5-FU', 'platinum/5-FU alone']","['EGFR copy number', 'overall survival, progression-free survival', 'overall survival']","[{'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0334246', 'cui_str': 'Squamous cell carcinoma, metastatic (morphologic abnormality)'}, {'cui': 'C0018670', 'cui_str': 'Head'}, {'cui': 'C0027536', 'cui_str': 'Necking (finding)'}]","[{'cui': 'C0995188', 'cui_str': 'cetuximab'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}]","[{'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",442.0,0.0274282,"Considering each of the models tested, no association of EGFR copy number with overall survival, progression-free survival or best overall response was found for patients treated with cetuximab plus platinum/5-FU. CONCLUSION Tumor EGFR copy number is not a predictive biomarker for the efficacy of cetuximab plus platinum/5-FU as first-line therapy for patients with R/M SCCHN.","[{'ForeName': 'L', 'Initials': 'L', 'LastName': 'Licitra', 'Affiliation': 'Division of Medical Oncology, Istituto Nazionale Tumori, Milan, Italy.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Mesia', 'Affiliation': ""Department of Medical Oncology, Catalan Institute of Oncology, L'Hospitalet de Llobregat, Barcelona, Spain.""}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Rivera', 'Affiliation': 'Medical Oncology Department, Marqués de Valdecilla University Hospital, Santander, Spain.'}, {'ForeName': 'É', 'Initials': 'É', 'LastName': 'Remenár', 'Affiliation': 'Head and Neck Department, National Institute of Oncology, Budapest, Hungary.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Hitt', 'Affiliation': 'Medical Oncology Department, University Hospital 12 de Octubre, Madrid, Spain.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Erfán', 'Affiliation': 'Department of Oncoradiology, Jósa András County Hospital, Nyíregyháza, Hungary.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Rottey', 'Affiliation': 'Medical Oncology, Ghent University Hospital, Gent, Belgium.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Kawecki', 'Affiliation': 'Head and Neck Cancer Department, Maria Sklodowska-Curie Memorial Cancer Centre and Institute of Oncology, Warsaw, Poland.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Zabolotnyy', 'Affiliation': 'Institute of Otolaryngology, Academy of Medical Sciences of Ukraine, Kiev, Ukraine.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Benasso', 'Affiliation': 'Oncology Department, San Paolo Hospital, Savona, Italy.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Störkel', 'Affiliation': 'Institute of Pathology, HELIOS Hospital Wuppertal, Wuppertal, Germany.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Senger', 'Affiliation': 'Global Biostatistics.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Stroh', 'Affiliation': 'Oncology Research, Merck KGaA, Darmstadt, Germany.'}, {'ForeName': 'J B', 'Initials': 'JB', 'LastName': 'Vermorken', 'Affiliation': 'Department of Medical Oncology, Antwerp University Hospital, Edegem, Belgium. Electronic address: jan.b.vermorken@uza.be.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdq588'] 3162,21048041,Pharmacogenetic interaction analysis for the efficacy of systemic treatment in metastatic colorectal cancer.,"BACKGROUND Pharmacogenetic markers related to drug metabolism and mechanisms of action could help to better select patients with metastatic colorectal cancer (mCRC) for treatment. Genetic interaction analysis is used as a rational tool to study the contribution of polygenic variation in relation to drug response. PATIENTS AND METHODS A selection of 17 polymorphisms in genes encoding drug targets, pathway molecules and detoxification enzymes was analyzed in 279 previously untreated mCRC patients treated with capecitabine, oxaliplatin and bevacizumab (CAPOX-B). Multifactor dimensionality reduction analysis was used to identify a genetic interaction profile for progression-free survival (PFS). RESULTS Median PFS was 10.9 [95% confidence interval (CI) 9.4-12.4] months. A genetic interaction profile consisting of the TYMS enhancer region and VEGF +405G>C polymorphisms was significantly associated with PFS. Median PFS was 13.3 (95% CI 11.4-15.3) and 9.7 (95% CI 7.6-11.8) months for the beneficial and unfavorable genetic profiles, respectively, corresponding to a hazards ratio for PFS of 1.58 (95% CI 1.14-2.19). None of the studied polymorphisms were individually associated with PFS. CONCLUSIONS Our results support a genetic interaction between the TYMS enhancer region and VEGF +405G>C polymorphisms as a predictor of the efficacy of CAPOX-B in mCRC patients.",2011,"RESULTS Median PFS was 10.9 [95% confidence interval (CI) 9.4-12.4] months.","['A selection of 17 polymorphisms in genes encoding drug targets, pathway molecules and detoxification enzymes was analyzed in 279 previously untreated mCRC patients treated with', 'patients with metastatic colorectal cancer (mCRC', 'metastatic colorectal cancer']","['capecitabine, oxaliplatin and bevacizumab (CAPOX-B']",['Median PFS'],"[{'cui': 'C0032529', 'cui_str': 'Polymorphism (Genetics)'}, {'cui': 'C0017337', 'cui_str': 'Genes'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0567416', 'cui_str': 'Molecule (substance)'}, {'cui': 'C0150543', 'cui_str': 'Detoxification therapy (regime/therapy)'}, {'cui': 'C3541394', 'cui_str': 'Enzymes'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0346973', 'cui_str': 'Secondary malignant neoplasm of large intestine'}]","[{'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0796392', 'cui_str': 'bevacizumab'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]",279.0,0.141156,"RESULTS Median PFS was 10.9 [95% confidence interval (CI) 9.4-12.4] months.","[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Pander', 'Affiliation': 'Department of Clinical Pharmacy & Toxicology.'}, {'ForeName': 'J A M', 'Initials': 'JAM', 'LastName': 'Wessels', 'Affiliation': 'Department of Clinical Pharmacy & Toxicology.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Gelderblom', 'Affiliation': 'Department of Clinical Oncology, Leiden University Medical Center, Leiden.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'van der Straaten', 'Affiliation': 'Department of Clinical Pharmacy & Toxicology.'}, {'ForeName': 'C J A', 'Initials': 'CJA', 'LastName': 'Punt', 'Affiliation': 'Department of Medical Oncology, Radboud University Nijmegen Medical Center, Nijmegen, The Netherlands.'}, {'ForeName': 'H-J', 'Initials': 'HJ', 'LastName': 'Guchelaar', 'Affiliation': 'Department of Clinical Pharmacy & Toxicology. Electronic address: h.j.guchelaar@lumc.nl.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdq572'] 3163,21059637,"A randomized phase III study comparing standard dose BEP with sequential high-dose cisplatin, etoposide, and ifosfamide (VIP) plus stem-cell support in males with poor-prognosis germ-cell cancer. An intergroup study of EORTC, GTCSG, and Grupo Germinal (EORTC 30974).","BACKGROUND To compare the efficacy of one cycle of standard dose cisplatin, etoposide, and ifosfamide (VIP) plus three cycles of high-dose VIP followed by stem-cell infusion [high-dose chemotherapy (HD-CT arm)] to four cycles of standard cisplatin, etoposide, and bleomycin (BEP) in patients with poor-prognosis germ-cell cancer (GCC). PATIENT AND METHODS Patients with poor-prognosis GCC were assigned to receive either BEP or VIP followed by HD-CT. To show a 15% improvement in a 1-year failure-free survival (FFS), the study aimed to recruit 222 patients but closed with 137, due to slow accrual. RESULTS One hundred thirty-one patients were included in this analysis. The complete response rates in the HD-CT and in the BEP arm did not differ: (intention to treat) 44.6% versus 33.3% (P = 0.18). There was no difference in FFS between the two treatment arms (P = 0.057, 66 events). At 2 years, the FFS rate was 44.8% [95% confidence interval (CI) 32.5-56.4] and 58.2%, respectively (95% CI 48.0-71.9); but this 16.3% (standard deviation 7.5%) difference was not statistically significant (P = 0.060). Overall survival did not differ between the two groups (log-rank P > 0.1, 47 deaths). CONCLUSION This study could not demonstrate that high-dose chemotherapy given as part of first-line therapy improves outcome in patients with poor-prognosis GCC.",2011,"There was no difference in FFS between the two treatment arms (P = 0.057, 66 events).","['One hundred thirty-one patients were included in this analysis', 'patients with poor-prognosis GCC', 'patients with poor-prognosis germ-cell cancer (GCC', '222 patients but closed with 137, due to slow accrual', 'Patients with poor-prognosis GCC', 'males with poor-prognosis germ-cell cancer']","['BEP with sequential high-dose cisplatin, etoposide, and ifosfamide (VIP) plus stem-cell support', 'standard cisplatin, etoposide, and bleomycin (BEP', 'BEP or VIP followed by HD-CT', 'cisplatin, etoposide, and ifosfamide (VIP) plus three cycles of high-dose VIP followed by stem-cell infusion [high-dose chemotherapy (HD-CT arm']","['1-year failure-free survival (FFS', 'FFS', 'complete response rates', 'FFS rate', 'Overall survival']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0450355', 'cui_str': '31 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0278252', 'cui_str': 'Prognosis bad (finding)'}, {'cui': 'C0740345', 'cui_str': 'Germ Cell Cancer'}, {'cui': 'C0587267', 'cui_str': 'Closed (qualifier value)'}, {'cui': 'C4517569', 'cui_str': 'One hundred and thirty-seven'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0439834', 'cui_str': 'Slowly'}, {'cui': 'C0086582', 'cui_str': 'Males'}]","[{'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0015133', 'cui_str': 'Etoposide'}, {'cui': 'C0020823', 'cui_str': 'Ifosfamide'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0038250', 'cui_str': 'Mother Cells'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0005740', 'cui_str': 'Bleomycin'}, {'cui': 'C0042395', 'cui_str': 'VIP'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}]","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",131.0,0.111575,"There was no difference in FFS between the two treatment arms (P = 0.057, 66 events).","[{'ForeName': 'G', 'Initials': 'G', 'LastName': 'Daugaard', 'Affiliation': 'Department of Oncology, Rigshospitalet, Copenhagen, Denmark. Electronic address: gedske.daugaard@rh.regionh.dk.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Skoneczna', 'Affiliation': 'Department of Urology, Chemotherapy Unit, Maria Sklodowska-Curie Memorial Center, Warsaw, Poland.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Aass', 'Affiliation': 'Department of Oncology, Oslo University Hospital and University of Oslo, Oslo, Norway.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'De Wit', 'Affiliation': 'Department Medical Oncology, Erasmus University Hospital, Rotterdam, The Netherlands.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'De Santis', 'Affiliation': 'LBI-ACR VIEnna and ACR-ITR VIEnna/CEADDP-Kaiser Franz Josef-Spital, Vienna, Austria.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Dumez', 'Affiliation': 'Department of Oncology, University Hospitals, Leuven, Belgium.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Marreaud', 'Affiliation': 'European Organization for Research and Treatment of Cancer Headquarters, Brussels, Belgium.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Collette', 'Affiliation': 'European Organization for Research and Treatment of Cancer Headquarters, Brussels, Belgium.'}, {'ForeName': 'J R G', 'Initials': 'JRG', 'LastName': 'Lluch', 'Affiliation': ""Institut Català d'Oncologia, Htal. Duran i Reynals, Hòspitalet Barcelona, Barcelona, Spain.""}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Bokemeyer', 'Affiliation': 'Department of Oncology, Hematology and Bone Marrow Transplantation with Section Pneumology, Hubertus Wald Cancer Center (UCCH), University Medical Center Hamburg Eppendorf, Hamburg.'}, {'ForeName': 'H J', 'Initials': 'HJ', 'LastName': 'Schmoll', 'Affiliation': 'Department of Oncology and Hematology, Martin Luther University, Halle, Germany.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdq575'] 3164,21385882,"PREPARE trial: a randomized phase III trial comparing preoperative, dose-dense, dose-intensified chemotherapy with epirubicin, paclitaxel and CMF versus a standard-dosed epirubicin/cyclophosphamide followed by paclitaxel ± darbepoetin alfa in primary breast cancer--results at the time of surgery.","BACKGROUND Preoperative chemotherapy is a recommended treatment of both primary operable and locally advanced breast cancer. Strategies to improve efficacy include the use of anthracyclines, taxanes, and intensified dose with bone marrow support. PATIENTS AND METHODS Patients received neoadjuvant epirubicin 90 mg/m(2) plus cyclophosphamide 600 mg/m(2) followed by paclitaxel 175 mg/m(2) (EC→T), each 3-weekly for four cycles (n = 370), or epirubicin 150 mg/m(2) followed by paclitaxel 225 mg/m(2) with pegfilgrastim followed by CMF (cyclophosphamide 500 mg/m(2), methotrexate 40 mg/m(2), fluorouracil 600 mg/m(2)) on days 1 and 8 (E(dd)→T(dd)→CMF), each 2-weekly and for three cycles (n = 363). Patients were randomly allocated to either simultaneous darbepoetin alfa (DA) (n = 356) or none (n = 377). RESULTS Pathological complete response (pCR) rate (breast) was higher with E(dd)→T(dd)→CMF, 18.7% versus 13.2% with EC→T; P = 0.043, ypT0/Tis; ypN0 was reported in 20.9% versus 14.3% respectively; P = 0.019. Patients with grade 3 tumors and negative hormone receptor status had a significantly higher pCR rate. Mean hemoglobin values maintained higher with DA (13.6 versus 12.6 g/dl). E(dd)→T(dd)→CMF regimen showed more grade 3-4 mucositis, sensory neuropathy, and neurological complaints. Thromboembolic events were more frequent on DA (3% versus 6%; P = 0.055). CONCLUSION Dose-dense and -intensified neoadjuvant chemotherapy with E(dd)→T(dd)→CMF was potentially superior to EC→T in terms of pCR. Primary use of DA did not affect pCR.",2011,"Thromboembolic events were more frequent on DA (3% versus 6%; P = 0.055). ","['primary breast cancer--results at the time of surgery', 'primary operable and locally advanced breast cancer', 'Patients received']","['epirubicin 150 mg/m(2) followed by paclitaxel 225 mg/m(2) with pegfilgrastim followed by CMF (cyclophosphamide 500 mg/m(2), methotrexate 40 mg/m(2), fluorouracil 600 mg/m(2)) on days 1 and 8 (E(dd)→T(dd)→CMF', 'E(dd)→T(dd)→CMF', 'simultaneous darbepoetin alfa (DA', 'anthracyclines, taxanes, and intensified dose with bone marrow support', 'neoadjuvant epirubicin 90 mg/m(2) plus cyclophosphamide 600 mg/m(2) followed by paclitaxel 175 mg/m(2) (EC→T', 'epirubicin, paclitaxel and CMF versus a standard-dosed epirubicin/cyclophosphamide followed by paclitaxel ± darbepoetin alfa']","['Thromboembolic events', 'grade 3-4 mucositis, sensory neuropathy, and neurological complaints', 'Pathological complete response (pCR) rate (breast', 'Mean hemoglobin values', 'pCR rate']","[{'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C1274040', 'cui_str': 'Result'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0205188', 'cui_str': 'Operable (qualifier value)'}, {'cui': 'C3495949', 'cui_str': 'Locally advanced breast cancer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0014582', 'cui_str': 'Epirubicin'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C4517652', 'cui_str': '225 (qualifier value)'}, {'cui': 'C1136535', 'cui_str': 'pegfilgrastim'}, {'cui': 'C0768190', 'cui_str': 'CMF (protein)'}, {'cui': 'C4080545', 'cui_str': 'Cyclophosphamide 500 MG'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0521115', 'cui_str': 'Simultaneous (qualifier value)'}, {'cui': 'C0937950', 'cui_str': 'darbepoetin alfa'}, {'cui': 'C0282564', 'cui_str': 'Anthracyclines'}, {'cui': 'C0796419', 'cui_str': 'Taxanes'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0005953', 'cui_str': 'Bone Marrow'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C4517605', 'cui_str': '175'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0040038', 'cui_str': 'Thromboembolism'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0333355', 'cui_str': 'Mucositis'}, {'cui': 'C0151313', 'cui_str': 'Sensory neuropathy (disorder)'}, {'cui': 'C0205494', 'cui_str': 'Neurologic (qualifier value)'}, {'cui': 'C0277786', 'cui_str': 'Presenting complaint'}, {'cui': 'C1521733', 'cui_str': 'Pathologic (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0006141', 'cui_str': 'Breast'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C3853643', 'cui_str': 'Probe with target amplification technique (qualifier value)'}]",,0.0195661,"Thromboembolic events were more frequent on DA (3% versus 6%; P = 0.055). ","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Untch', 'Affiliation': 'Department of Obstetrics and Gynecology, Helios Klinikum Berlin-Buch, Berlin. Electronic address: michael.untch@helios-kliniken.de.'}, {'ForeName': 'P A', 'Initials': 'PA', 'LastName': 'Fasching', 'Affiliation': 'Department of Obstetrics and Gynecology, University Hospital Erlangen, Erlangen, Germany.'}, {'ForeName': 'G E', 'Initials': 'GE', 'LastName': 'Konecny', 'Affiliation': 'Division of Hematology and Oncology, David Geffen School of Medicine at University of California, Los Angeles, USA.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'von Koch', 'Affiliation': 'Department of Obstetrics and Gynecology, Ludwig-Maximilians-University Großhadern, Munich.'}, {'ForeName': 'U', 'Initials': 'U', 'LastName': 'Conrad', 'Affiliation': 'Department of Obstetrics and Gynecology, St. Barbara Hospital, Hamm.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Fett', 'Affiliation': 'Hematologic/Oncologic Clinic, Wuppertal.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Kurzeder', 'Affiliation': ""University Women's Hospital of Ulm, Ulm.""}, {'ForeName': 'H-J', 'Initials': 'HJ', 'LastName': 'Lück', 'Affiliation': 'Department of Obstetrics and Gynecology, Medical University of Hannover, Hannover.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Stickeler', 'Affiliation': ""University Women's Hospital of Freiburg, Freiburg.""}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Urbaczyk', 'Affiliation': 'City Hospital, Kassel.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Liedtke', 'Affiliation': 'Department of Obstetrics and Gynecology, Protestant Hospital, Bergisch Gladbach.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Salat', 'Affiliation': 'Hematologic/Oncologic Practice München.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Harbeck', 'Affiliation': 'Department of Obstetrics and Gynecology, Technical University of Munich, Munich.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Müller', 'Affiliation': 'Department of Obstetrics and Gynecology, University Hospital Hamburg-Eppendorf, Hamburg.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Schmidt', 'Affiliation': ""University Women's Hospital of Mainz, Mainz.""}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Hasmüller', 'Affiliation': 'Department of Obstetrics and Gynecology, Ludwig-Maximilians-University Großhadern, Munich.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Lenhard', 'Affiliation': 'Department of Obstetrics and Gynecology, Ludwig-Maximilians-University Großhadern, Munich.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Schuster', 'Affiliation': 'Institute for Medical Statistics and Epidemiology, Technical University Munich, Munich.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Nekljudova', 'Affiliation': 'German Breast Group, Neu-Isenburg.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Lebeau', 'Affiliation': 'Department of Pathology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Loibl', 'Affiliation': 'German Breast Group, Neu-Isenburg.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'von Minckwitz', 'Affiliation': 'German Breast Group, Neu-Isenburg.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdq709'] 3165,21273348,"Phase II trial of combretastatin A4 phosphate, carboplatin, and paclitaxel in patients with platinum-resistant ovarian cancer.","BACKGROUND A previous dose-escalation trial of the vascular disrupting agent combretastatin A4 phosphate (CA4P) given before carboplatin, paclitaxel, or both showed responses in 7 of 18 patients with relapsed ovarian cancer. PATIENTS AND METHODS Patients with ovarian cancer that had relapsed and who could start trial therapy within 6 months of their last platinum chemotherapy were given CA4P 63 mg/m(2) minimum 18 h before paclitaxel 175 mg/m(2) and carboplatin AUC (area under the concentration curve) 5, repeated every 3 weeks. RESULTS Five of the first 18 patients' disease responded, so the study was extended and closed after 44 patients were recruited. Grade ≥2 toxic effects were neutropenia in 75% and thrombocytopenia in 9% of patients (weekly blood counts), tumour pain, fatigue, and neuropathy, with one patient with rapidly reversible ataxia. Hypertension (23% of patients) was controlled by glyceryl trinitrate or prophylactic amlodipine. The response rate by RECIST was 13.5% and by Gynecologic Cancer InterGroup CA 125 criteria 34%. CONCLUSIONS The addition of CA4P to paclitaxel and carboplatin is well tolerated and appears to produce a higher response rate in this patient population than if the chemotherapy was given without CA4P. A planned randomised trial will test this hypothesis.",2011,"The response rate by RECIST was 13.5% and by Gynecologic Cancer InterGroup CA 125 criteria 34%. ","['Patients with ovarian cancer that had relapsed and who could start trial therapy within 6 months of their last', ""18 patients' disease responded, so the study was extended and closed after 44 patients were recruited"", 'patients with platinum-resistant ovarian cancer', '18 patients with relapsed ovarian cancer']","['platinum chemotherapy', 'combretastatin A4 phosphate, carboplatin, and paclitaxel', 'vascular disrupting agent combretastatin A4 phosphate (CA4P) given before carboplatin, paclitaxel', 'CA4P 63 mg/m(2) minimum 18 h before paclitaxel 175 mg/m(2) and carboplatin AUC', 'glyceryl trinitrate or prophylactic amlodipine', 'CA4P to paclitaxel and carboplatin']","['thrombocytopenia', 'tumour pain, fatigue, and neuropathy', 'Hypertension', 'neutropenia', 'response rate by RECIST']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1140680', 'cui_str': 'Ovary Cancer'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0231449', 'cui_str': 'Extended (qualifier value)'}, {'cui': 'C0587267', 'cui_str': 'Closed (qualifier value)'}, {'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C0332325', 'cui_str': 'Resistant (qualifier value)'}]","[{'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0796467', 'cui_str': 'combretastatin A4 phosphate'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0450442', 'cui_str': 'Agent (attribute)'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C4517605', 'cui_str': '175'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0017887', 'cui_str': 'glyceryl trinitrate'}, {'cui': 'C0445202', 'cui_str': 'Prophylactic (qualifier value)'}, {'cui': 'C0051696', 'cui_str': 'Amlodipine'}]","[{'cui': 'C0040034', 'cui_str': 'Thrombopenia'}, {'cui': 'C0854069', 'cui_str': 'Tumor pain'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0442874', 'cui_str': 'Neuropathy (disorder)'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C1709926', 'cui_str': 'RECIST'}]",44.0,0.121135,"The response rate by RECIST was 13.5% and by Gynecologic Cancer InterGroup CA 125 criteria 34%. ","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Zweifel', 'Affiliation': 'Department of Medical Oncology, Mount Vernon Cancer Centre, Northwood.'}, {'ForeName': 'G C', 'Initials': 'GC', 'LastName': 'Jayson', 'Affiliation': 'School of Cancer and Enabling Sciences, University of Manchester & Christie Hospital, Manchester.'}, {'ForeName': 'N S', 'Initials': 'NS', 'LastName': 'Reed', 'Affiliation': 'Beatson Oncology Centre, Western Infirmary, Glasgow.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Osborne', 'Affiliation': 'Dorset Cancer Centre, Poole Hospital NHS Foundation Trust, Poole.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Hassan', 'Affiliation': 'Department of Medical Oncology, Churchill Hospital, Oxford.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Ledermann', 'Affiliation': 'UCL Cancer Institute, Cancer Research UK & University College of London Cancer Trials Centre, London, UK.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Shreeves', 'Affiliation': 'Department of Medical Oncology, Mount Vernon Cancer Centre, Northwood.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Poupard', 'Affiliation': 'Department of Medical Oncology, Mount Vernon Cancer Centre, Northwood.'}, {'ForeName': 'S-P', 'Initials': 'SP', 'LastName': 'Lu', 'Affiliation': 'OXiGENE Inc., San Francisco, USA.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Balkissoon', 'Affiliation': 'OXiGENE Inc., San Francisco, USA.'}, {'ForeName': 'D J', 'Initials': 'DJ', 'LastName': 'Chaplin', 'Affiliation': 'OXiGENE Inc., San Francisco, USA.'}, {'ForeName': 'G J S', 'Initials': 'GJS', 'LastName': 'Rustin', 'Affiliation': 'Department of Medical Oncology, Mount Vernon Cancer Centre, Northwood. Electronic address: grustin@nhs.net.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdq708'] 3166,21382868,"PREPARE trial: a randomized phase III trial comparing preoperative, dose-dense, dose-intensified chemotherapy with epirubicin, paclitaxel, and CMF versus a standard-dosed epirubicin-cyclophosphamide followed by paclitaxel with or without darbepoetin alfa in primary breast cancer--outcome on prognosis.","BACKGROUND The objective of this study was to compare the effect of dose-intensified neoadjuvant chemotherapy with that of standard epirubicin plus cyclophosphamide followed by paclitaxel in combination with or without darbepoetin on survival in primary breast cancer. PATIENTS AND METHODS A total of 733 patients received either four cycles of neoadjuvant epirubicin 90 mg/m(2) plus cyclophosphamide 600 mg/m(2) every 3 weeks followed by four cycles of paclitaxel 175 mg/m(2) every 3 weeks (EC→T), or three cycles of epirubicin 150 mg/m(2) every 2 weeks followed by three cycles of paclitaxel 225 mg/m(2) every 2 weeks followed by three cycles of combination chemotherapy with cyclophosphamide, methotrexate, and fluorouracil (E(dd)→T(dd)→CMF). The patients were randomly assigned to receive darbepoetin or none. The primary objective was to demonstrate a superior disease-free survival (DFS) of E(dd)→T(dd)→CMF compared with EC→T. RESULTS Estimated 3-year DFS was 75.8% with EC→T versus 78.8% with E(dd)→T(dd)→CMF [hazard ratio (HR) 1.14; P = 0.37] and overall survival (OS) 88.4% versus 91.5% (HR 1.26; P = 0.237). Three-year DFS was 74.3% with darbepoetin versus 80.0% without (HR 1.31; P = 0.061) and OS 88.0% versus 91.8% (HR 1.33; P = 0.139). Patients with a pathologically documented complete response [pathological complete response (pCR)] had a significantly better DFS compared with those without achieving a pCR (estimated 3-year DFS: 89.2% versus 74.9%; HR 2.27; P = 0.001). CONCLUSION Neoadjuvant dose-intensified chemotherapy compared with standard chemotherapy did not improve DFS, whereas the addition of darbepoetin might have detrimental effects on DFS.",2011,Three-year DFS was 74.3% with darbepoetin versus 80.0% without (HR 1.31; P = 0.061) and OS 88.0% versus 91.8% (HR 1.33; P = 0.139).,"['733 patients', 'primary breast cancer', 'primary breast cancer--outcome on prognosis']","['standard epirubicin plus cyclophosphamide', 'paclitaxel 225 mg/m(2) every 2 weeks followed by three cycles of combination chemotherapy with cyclophosphamide, methotrexate, and fluorouracil (E(dd)→T(dd)→CMF', 'neoadjuvant epirubicin 90 mg/m(2) plus cyclophosphamide', 'epirubicin, paclitaxel, and CMF versus a standard-dosed epirubicin-cyclophosphamide followed by paclitaxel with or without darbepoetin alfa', 'paclitaxel 175 mg/m(2) every 3 weeks (EC→T), or three cycles of epirubicin', 'darbepoetin']","['complete response [pathological complete response (pCR', 'DFS', 'overall survival', 'superior disease-free survival (DFS) of E(dd)→T(dd)→CMF']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0033325', 'cui_str': 'Prognosis'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0014582', 'cui_str': 'Epirubicin'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C4517652', 'cui_str': '225 (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0013218', 'cui_str': 'Combination Drug Therapy'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0768190', 'cui_str': 'CMF (protein)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0937950', 'cui_str': 'darbepoetin alfa'}, {'cui': 'C4517605', 'cui_str': '175'}]","[{'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C1521733', 'cui_str': 'Pathologic (qualifier value)'}, {'cui': 'C3853643', 'cui_str': 'Probe with target amplification technique (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}]",733.0,0.058578,Three-year DFS was 74.3% with darbepoetin versus 80.0% without (HR 1.31; P = 0.061) and OS 88.0% versus 91.8% (HR 1.33; P = 0.139).,"[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Untch', 'Affiliation': 'Department of Obstetrics and Gynecology, Helios Klinikum Berlin-Buch, Berlin. Electronic address: michael.untch@helios-kliniken.de.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'von Minckwitz', 'Affiliation': 'German Breast Group, Neu-Isenburg, Germany.'}, {'ForeName': 'G E', 'Initials': 'GE', 'LastName': 'Konecny', 'Affiliation': 'Division of Hematology and Oncology, David Geffen School of Medicine, University of California, Los Angeles, USA.'}, {'ForeName': 'U', 'Initials': 'U', 'LastName': 'Conrad', 'Affiliation': 'Department of Obstetrics and Gynecology, St Barbara Hospital, Hamm.'}, {'ForeName': 'W', 'Initials': 'W', 'LastName': 'Fett', 'Affiliation': 'Hematologic/Oncologic Practice, Wuppertal.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Kurzeder', 'Affiliation': ""University Women's Hospital of Ulm, Ulm.""}, {'ForeName': 'H-J', 'Initials': 'HJ', 'LastName': 'Lück', 'Affiliation': 'Department of Obstetrics and Gynecology, Medical University of Hannover, Hannover.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Stickeler', 'Affiliation': ""University Women's Hospital of Freiburg, Freiburg.""}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Urbaczyk', 'Affiliation': 'Klinikum, Kassel.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Liedtke', 'Affiliation': 'Krankenhaus Bergisch, Gladbach.'}, {'ForeName': 'M W', 'Initials': 'MW', 'LastName': 'Beckmann', 'Affiliation': 'University Breast Center Franconia, Department of Gynecology and Obstetrics, University Hospital Erlangen, Erlangen.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Salat', 'Affiliation': 'Hematologic/Oncologic Clinic München, Munich.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'Harbeck', 'Affiliation': 'Department of Obstetrics and Gynecology, Technical University of Munich, Munich.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Müller', 'Affiliation': 'Department of Obstetrics and Gynecology, University Hospital Hamburg-Eppendorf, Hamburg.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Schmidt', 'Affiliation': ""University Women's Hospital of Mainz, Mainz.""}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Hasmüller', 'Affiliation': 'Department of Obstetrics and Gynecology, Ludwig-Maximilians-University Großhadern, Munich.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Lenhard', 'Affiliation': 'Department of Obstetrics and Gynecology, Ludwig-Maximilians-University Großhadern, Munich.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Nekljudova', 'Affiliation': 'German Breast Group, Neu-Isenburg, Germany.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Lebeau', 'Affiliation': 'Department of Pathology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Loibl', 'Affiliation': 'German Breast Group, Neu-Isenburg, Germany.'}, {'ForeName': 'P A', 'Initials': 'PA', 'LastName': 'Fasching', 'Affiliation': 'University Breast Center Franconia, Department of Gynecology and Obstetrics, University Hospital Erlangen, Erlangen.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdq713'] 3167,21078826,Intermittent versus continuous chemotherapy in advanced colorectal cancer: a randomised 'GISCAD' trial.,"BACKGROUND In advanced colorectal cancer, chemotherapy is usually administered without pauses and until progression but patients can experience cumulative toxicity and cannot tolerate a heavy therapeutic charge. AIM The aim of the present trial was to evaluate whether an intermittent chemotherapy with levo-leucovorin + 5-fluorouracil (5-FU) + irinotecan (CPT-11) was at least as effective as the same regimen given continuously, both administered until progression, in patients affected with advanced colorectal cancer and not previously exposed to chemotherapy for metastatic disease. PATIENTS, MATERIALS AND METHODS A total of 337 patients from 27 institutions were randomised between levo-leucovorin, 100/mg/m(2) i.v. + 5-FU; 400 mg/m(2) i.v. bolus + 5-FU; 600 mg/m(2) 22-h continuous infusion, days 1 and 2 + CPT-11; 180 mg/m(2) day 1, administered every 2 weeks 2 months on and 2 months off (arm A) and the same regimen administered continuously (arm B), until progression in both arms. The main end point was overall survival (OS), the secondary progression-free survival (PFS) and toxicity. RESULTS At a median follow-up of 41 months, OS was 18 months in arm A and 17 months in arm B [hazard ratio (HR), 0.88]. Also PFS was comparable in the two groups (6 months in both, with HR, 1.03), and even grades 3-4 toxicity (mainly myelosuppression, fever and diarrhoea) was similar. Second-line oxaliplatin-based treatment was administered in a similar percentage (66%) in the two arms. The median chemotherapy-free period (drug holiday) in arm A was 3.5 months. CONCLUSION Reducing the charge of therapy in this population did not diminish the efficacy of treatment. Further studies with this strategy, including biologicals, are warranted.",2011,"At a median follow-up of 41 months, OS was 18 months in arm A and 17 months in arm B [hazard ratio (HR), 0.88].","['337 patients from 27 institutions', 'advanced colorectal cancer', 'patients affected with advanced colorectal cancer and not previously exposed to chemotherapy for metastatic disease']","['Second-line oxaliplatin', 'continuous chemotherapy', 'intermittent chemotherapy with levo-leucovorin + 5-fluorouracil (5-FU) + irinotecan (CPT-11', ' 5-FU', 'levo-leucovorin', 'bolus + 5-FU']","['toxicity (mainly myelosuppression, fever and diarrhoea', 'overall survival (OS), the secondary progression-free survival (PFS) and toxicity']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1272753', 'cui_str': 'Institution'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0346629', 'cui_str': 'Malignant tumor of large intestine (disorder)'}, {'cui': 'C0522476', 'cui_str': 'Patient affected (contextual qualifier) (qualifier value)'}, {'cui': 'C0332157', 'cui_str': 'Exposure to (contextual qualifier) (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C2939420', 'cui_str': 'Metastatic disease'}]","[{'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0069717', 'cui_str': 'oxaliplatin'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0205267', 'cui_str': 'Intermittent (qualifier value)'}, {'cui': 'C2721771', 'cui_str': 'levoleucovorin'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0123931', 'cui_str': 'irinotecan'}, {'cui': 'C4317169', 'cui_str': 'CPT-11'}]","[{'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0854467', 'cui_str': 'Myelosuppression (finding)'}, {'cui': 'C0015967', 'cui_str': 'Hyperthermia'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}]",337.0,0.177388,"At a median follow-up of 41 months, OS was 18 months in arm A and 17 months in arm B [hazard ratio (HR), 0.88].","[{'ForeName': 'R', 'Initials': 'R', 'LastName': 'Labianca', 'Affiliation': 'Oncologia Medica, Ospedali Riuniti, Bergamo. Electronic address: rlabian@tin.it.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Sobrero', 'Affiliation': 'Oncologia Medica, Ospedale S.Martino, Genova.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Isa', 'Affiliation': 'Oncologia Medica, Ospedale Serbelloni, Gorgonzola, Milan.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Cortesi', 'Affiliation': 'Oncologia Medica, Policlinico Umberto I, Roma.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Barni', 'Affiliation': 'Oncologia Medica, Ospedale Treviglio-Caravaggio, Treviglio.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Nicolella', 'Affiliation': 'Oncologia Medica, A.O. S.Giuseppe Moscati, Avellino.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Aglietta', 'Affiliation': 'Oncologia Medica, Istituto Ricerca e Cura del Cancro, Candiolo.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Lonardi', 'Affiliation': 'Oncologia Medica, Istituto Oncologico Veneto, Padova.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Corsi', 'Affiliation': 'Oncologia, Ospedale Fatebenefratelli-Isola Tiberina, Roma.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Turci', 'Affiliation': 'Oncologia e Ematologia, A.O. S.Maria delle Croci, Ravenna.'}, {'ForeName': 'G D', 'Initials': 'GD', 'LastName': 'Beretta', 'Affiliation': 'Oncologia Medica, Ospedali Riuniti, Bergamo.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Fornarini', 'Affiliation': 'Oncologia Medica, Ospedale S.Martino, Genova.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Dapretto', 'Affiliation': 'Oncology Department, A.O. Ospedale S.Gerardo, Monza.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Floriani', 'Affiliation': 'Laboratorio di Epidemiologia, Clinica Istituto, Ricerche Farmacologiche Mario Negri, Milano.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Zaniboni', 'Affiliation': 'Oncologia Medica, Fondazione Poliambulanza, Brescia, Italy.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdq580'] 3168,21084429,Phase III trial of gemcitabine plus docetaxel versus capecitabine plus docetaxel with planned crossover to the alternate single agent in metastatic breast cancer.,"BACKGROUND Safety and efficacy of gemcitabine plus docetaxel (GD) and capecitabine plus docetaxel (CD) were compared in patients with metastatic breast cancer, where the alternate crossover monotherapy (GD→C or CD→G) was predetermined. PATIENTS AND METHODS Patients were randomly assigned to 3-week cycles of either gemcitabine 1000 mg/m(2) on days 1 and 8 plus docetaxel 75 mg/m(2) on day 1 or capecitabine 1000 mg/m(2) twice daily on days 1-14 plus docetaxel 75 mg/m(2) day 1. Upon progression, patients received crossover monotherapy. Primary end point was time to progression (TtP). Secondary end points evaluated overall response rate (ORR), overall survival (OS), and adverse events (AEs). RESULTS Despite over-accrual of 475 patients, the trial matured with only 324 of 385 planned TtP events due to patient discontinuations. Human epidermal growth factor receptor 2 status was not captured in this study. More CD patients (28%) discontinued due to AEs than GD patients (18.0%, P = 0.009). TtP [hazard ratio (HR) = 1.101, 95% confidence interval (CI) 0.885-1.370, P = 0.387] and OS (HR = 1.031, 95% CI 0.830-1.280, P = 0.785) were not significantly different comparing GD and CD. ORR was not statistically different (P = 0.239) comparing GD (72 of 207, 34.8%) and CD (78 of 191, 40.8%). TtP, OS, and ORR were not significantly different comparing crossover groups. GD caused greater fatigue, hepatotoxicity, neutropenia, and thrombocytopenia but not febrile neutropenia; CD caused more hand-foot syndrome, gastrointestinal toxicity, and mucositis. CONCLUSIONS GD and CD produced similar efficacy and toxicity profiles consistent with prior clinical experience.",2011,"TtP, OS, and ORR were not significantly different comparing crossover groups.","['Patients', 'metastatic breast cancer', 'patients with metastatic breast cancer']","['gemcitabine plus docetaxel versus capecitabine plus docetaxel', 'gemcitabine 1000 mg/m(2) on days 1 and 8 plus docetaxel 75 mg/m(2) on day 1 or capecitabine 1000 mg/m(2) twice daily on days 1-14 plus docetaxel', 'monotherapy (GD→C or CD→G', 'gemcitabine plus docetaxel (GD) and capecitabine plus docetaxel (CD']","['time to progression (TtP', 'TtP, OS, and ORR', 'overall response rate (ORR), overall survival (OS), and adverse events (AEs', 'ORR', 'fatigue, hepatotoxicity, neutropenia, and thrombocytopenia but not febrile neutropenia; CD caused more hand-foot syndrome, gastrointestinal toxicity, and mucositis', 'efficacy and toxicity profiles', 'TtP [hazard ratio (HR) ']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0278488', 'cui_str': 'Breast cancer metastatic'}]","[{'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0246415', 'cui_str': 'docetaxel'}, {'cui': 'C0671970', 'cui_str': 'capecitabine'}, {'cui': 'C4057589', 'cui_str': 'gemcitabine 1000 MG'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C1883310', 'cui_str': '1000 (qualifier value)'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0449258', 'cui_str': 'Progression (attribute)'}, {'cui': 'C0034155', 'cui_str': 'Moschkowitz Disease'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0235378', 'cui_str': 'Hepatotoxicity'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C0040034', 'cui_str': 'Thrombopenia'}, {'cui': 'C0746883', 'cui_str': 'Febrile Neutropenia'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0852711', 'cui_str': 'Hand-foot syndrome in sickle cell anemia (disorder)'}, {'cui': 'C1142499', 'cui_str': 'Gastrointestinal toxicity'}, {'cui': 'C0333355', 'cui_str': 'Mucositis'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}]",,0.0506339,"TtP, OS, and ORR were not significantly different comparing crossover groups.","[{'ForeName': 'A D', 'Initials': 'AD', 'LastName': 'Seidman', 'Affiliation': 'Department of Medicine, Memorial Sloan Kettering Cancer Center, New York. Electronic address: seidmana@mskcc.org.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Brufsky', 'Affiliation': ""Women's Cancer Center, Magee Women's Hospital, Pittsburgh.""}, {'ForeName': 'R H', 'Initials': 'RH', 'LastName': 'Ansari', 'Affiliation': 'Michiana Hematology Oncology, South Bend.'}, {'ForeName': 'L L', 'Initials': 'LL', 'LastName': 'Hart', 'Affiliation': 'Florida Cancer Specialists, Venice.'}, {'ForeName': 'R S', 'Initials': 'RS', 'LastName': 'Stein', 'Affiliation': 'Department of Molecular Physiology and Biophysics, Vanderbilt-Ingram Cancer Center, Nashville.'}, {'ForeName': 'L S', 'Initials': 'LS', 'LastName': 'Schwartzberg', 'Affiliation': 'Hematology and Medical Oncology, The West Clinic, Memphis, USA.'}, {'ForeName': 'J F', 'Initials': 'JF', 'LastName': 'Stewart', 'Affiliation': 'Calvary Mater Hospital, Waratah, Australia.'}, {'ForeName': 'C A', 'Initials': 'CA', 'LastName': 'Russell', 'Affiliation': 'Department of Clinical Medicine, University of Southern California, Los Angeles, USA.'}, {'ForeName': 'S-C', 'Initials': 'SC', 'LastName': 'Chen', 'Affiliation': 'Department of Surgery, Chang Gung Memorial Hospital, Taipei, Taiwan.'}, {'ForeName': 'L E', 'Initials': 'LE', 'LastName': 'Fein', 'Affiliation': 'Centro de Oncologia Rosario, Santa Fe, Argentina.'}, {'ForeName': 'J A', 'Initials': 'JA', 'LastName': 'De La Cruz Vargas', 'Affiliation': 'Department of Oncology and Clinical Research, Acapulco Oncology Group, Acapulco, Mexico.'}, {'ForeName': 'S-B', 'Initials': 'SB', 'LastName': 'Kim', 'Affiliation': 'Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Cavalheiro', 'Affiliation': 'Hospital de Clinicas, Porto Alegre, Brazil.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Zhao', 'Affiliation': 'Lilly USA, LLC, Indianapolis.'}, {'ForeName': 'J F', 'Initials': 'JF', 'LastName': 'Gill', 'Affiliation': 'Lilly USA, LLC, Indianapolis.'}, {'ForeName': 'C K', 'Initials': 'CK', 'LastName': 'Obasaju', 'Affiliation': 'Lilly USA, LLC, Indianapolis.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Orlando', 'Affiliation': 'Eli Lilly and Company, Indianapolis, USA.'}, {'ForeName': 'D F', 'Initials': 'DF', 'LastName': 'Tai', 'Affiliation': 'Lilly USA, LLC, Indianapolis.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdq578'] 3169,21324954,Minimal clinically meaningful differences for the EORTC QLQ-C30 and EORTC QLQ-BN20 scales in brain cancer patients.,"BACKGROUND We aimed to determine the smallest changes in health-related quality of life (HRQoL) scores in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire core 30 and the Brain Cancer Module (QLQ-BN20), which could be considered as clinically meaningful in brain cancer patients. MATERIALS AND METHODS World Health Organisation performance status (PS) and mini-mental state examination (MMSE) were used as clinical anchors appropriate to related subscales to determine the minimal clinically important differences (MCIDs) in HRQoL change scores (range 0-100) in the QLQ-C30 and QLQ-BN20. A threshold of 0.2 standard deviation (SD) (small effect) was used to exclude anchor-based MCID estimates considered too small to inform interpretation. RESULTS Based on PS, our findings support the following integer estimates of the MCID for improvement and deterioration, respectively: physical (6, 9), role (14, 12), and cognitive functioning (8, 8); global health status (7, 4*), fatigue (12, 9), and motor dysfunction (4*, 5). Anchoring with MMSE, cognitive functioning MCID estimates for improvement and deterioration were (11, 2*) and for communication deficit were (9, 7). Estimates with asterisks were <0.2 SD and were excluded from our MCID range of 5-14. CONCLUSION These estimates can help clinicians evaluate changes in HRQoL over time, assess the value of a health care intervention and can be useful in determining sample sizes in designing future clinical trials.",2011,"Anchoring with MMSE, cognitive functioning MCID estimates for improvement and deterioration were (11, 2*) and for communication deficit were (9, 7).",['brain cancer patients'],['mini-mental state examination (MMSE'],"['fatigue (12, 9), and motor dysfunction', 'cognitive functioning (8, 8); global health status', 'EORTC QLQ-C30 and EORTC QLQ-BN20 scales', 'health-related quality of life (HRQoL) scores']","[{'cui': 'C0153633', 'cui_str': 'Brain Cancer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0451306', 'cui_str': 'Folstein Mini-Mental State Examination'}]","[{'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0521654', 'cui_str': 'Neurologic Deficits'}, {'cui': 'C1456573', 'cui_str': 'Global Health'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0222045'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.08255,"Anchoring with MMSE, cognitive functioning MCID estimates for improvement and deterioration were (11, 2*) and for communication deficit were (9, 7).","[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Maringwa', 'Affiliation': 'Quality of Life Department, European Organisation for Research and Treatment of Cancer, Brussels, Belgium. Electronic address: john.maringwa@eortc.be.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Quinten', 'Affiliation': 'Quality of Life Department, European Organisation for Research and Treatment of Cancer, Brussels, Belgium.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'King', 'Affiliation': 'Psycho-oncology Co-operative Research Group, University of Sydney, Sydney, Australia.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Ringash', 'Affiliation': 'Department of Radiation Oncology, The Princess Margaret Hospital, University of Toronto, Toronto.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Osoba', 'Affiliation': 'Quality of Life Consulting, West Vancouver, Canada.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Coens', 'Affiliation': 'Quality of Life Department, European Organisation for Research and Treatment of Cancer, Brussels, Belgium.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Martinelli', 'Affiliation': 'Quality of Life Department, European Organisation for Research and Treatment of Cancer, Brussels, Belgium.'}, {'ForeName': 'B B', 'Initials': 'BB', 'LastName': 'Reeve', 'Affiliation': 'Department of Health Policy and Management, Gillings School of Global Public Health, University of North Caroline at Chapel Hill, Chapel Hill, USA.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Gotay', 'Affiliation': 'Department of Health Care and Epidemiology, School of Population and Public Health, University of British Columbia, Vancouver, Canada.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Greimel', 'Affiliation': 'Department of Obstetrics and Gynecology, Medical University Graz, Graz, Austria.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Flechtner', 'Affiliation': 'Department of Child and Adolescent Psychiatry and Psychotherapy, University of Magdeburg, Magdeburg, Germany.'}, {'ForeName': 'C S', 'Initials': 'CS', 'LastName': 'Cleeland', 'Affiliation': 'Department of Symptom Research, University of Texas, Houston, USA.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Schmucker-Von Koch', 'Affiliation': 'Medical Ethics, University of Regensburg, Regensburg.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Weis', 'Affiliation': 'Department of Rehabilitation Psychology, Tumor Biology Center, University of Freiburg, Freiburg, Germany.'}, {'ForeName': 'M J', 'Initials': 'MJ', 'LastName': 'Van Den Bent', 'Affiliation': 'AZ Rotterdam-Daniel Den Hoed Kliniek, Rotterdam, The Netherlands.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Stupp', 'Affiliation': 'Department of Neurosurgery, Multidisciplinary Center for Oncology, University Hospital CHUV, Lausanne, Switzerland.'}, {'ForeName': 'M J', 'Initials': 'MJ', 'LastName': 'Taphoorn', 'Affiliation': 'Department of Neurology, Medical Center Haaglanden, The Hague, Netherlands.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Bottomley', 'Affiliation': 'Quality of Life Department, European Organisation for Research and Treatment of Cancer, Brussels, Belgium.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdq726'] 3170,32017599,Interactions of sprint interval exercise and psychological need-support on subsequent food intake among physically inactive men and women.,"The aim of this study was to investigate the effect of sprint interval training (SIT) and psychological need-support in exercise on postexercise appetite and energy intake. Forty physically inactive men and women (body mass index, 24.6 ± 4.8 kg·m -2 ; peak oxygen consumption, 26.6 ± 4.9 mL·kg -1 ·min -1 ) were randomised to either a need-support or no-support condition, with each participant completing 2 experimental trials involving 30 min of moderate-intensity continuous training (MICT; 60% peak oxygen consumption) and SIT (alternating 15 s at 170% peak oxygen consumption and 60 s at 32% peak oxygen consumption) matched for total work. Perceptions of appetite and appetite-related blood variables were assessed, together with ad libitum energy intake for 3 h following exercise using a laboratory test meal and available snacks. Greater enjoyment, perceived exertion, heart rate, and blood lactate were observed in SIT compared with MICT (all p ≤ 0.006). Ratings of perceived appetite were similar across conditions and trials ( p > 0.05); however, active ghrelin was lower following SIT compared with MICT ( p < 0.001), and there was a significant condition-by-type interaction for energy intake ( p = 0.033), with participants in the support group consuming less energy from foods following SIT (1895 ± 1040 kJ) than MICT (2475 ± 1192 kJ). Findings from this work highlight the need to reconsider traditional exercise guidelines where dietary intake is a concern. Novelty Enjoyment was greater during SIT compared with MICT. Enjoyment and choice were higher among participants provided with psychological need-support. In a need-supportive environment, SIT reduced subsequent energy intake compared with MICT.",2020,- Enjoyment was greater during SIT compared with MICT - Enjoyment and choice were higher among participants provided with psychological need-support -,"['Forty physically inactive men and women (BMI 24.6 ± 4.8 kg·m-2, V̇O2peak 26.6 ± 4.9 mL·kg-1·min-1', 'physically inactive men and women']","['need-support or no-support condition, with each participant completing two experimental trials involving 30 min of moderate-intensity continuous cycling (MICT; 60% V̇O2peak) and SIT', 'sprint interval exercise and psychological need-support', 'sprint interval exercise (SIT) and psychological need-support in exercise']","[' Enjoyment', 'active ghrelin', 'Greater enjoyment, perceived exertion, heart rate, and blood lactate', 'Ratings of perceived appetite']","[{'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C4517765', 'cui_str': '4.8 (qualifier value)'}]","[{'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C4081855', 'cui_str': 'Moderate intensity'}, {'cui': 'C0549178', 'cui_str': 'Continuous (qualifier value)'}, {'cui': 'C2584297', 'cui_str': 'Seated Position'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}]","[{'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0911014', 'cui_str': 'Ghrelin (substance)'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0015264', 'cui_str': 'Exertion, function (observable entity)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0005768'}, {'cui': 'C0202115', 'cui_str': 'Lactic acid measurement (procedure)'}, {'cui': 'C0003618', 'cui_str': 'Appetite'}]",40.0,0.120476,- Enjoyment was greater during SIT compared with MICT - Enjoyment and choice were higher among participants provided with psychological need-support -,"[{'ForeName': 'Natalya J', 'Initials': 'NJ', 'LastName': 'Beer', 'Affiliation': 'School of Human Sciences (Exercise and Sport Science), The University of Western Australia, Perth, WA 6009, Australia.'}, {'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'Dimmock', 'Affiliation': 'Department of Psychology, College of Healthcare Sciences, James Cook University, Townsville, QLD 4811, Australia.'}, {'ForeName': 'Ben', 'Initials': 'B', 'LastName': 'Jackson', 'Affiliation': 'School of Human Sciences (Exercise and Sport Science), The University of Western Australia, Perth, WA 6009, Australia.'}, {'ForeName': 'Kym J', 'Initials': 'KJ', 'LastName': 'Guelfi', 'Affiliation': 'School of Human Sciences (Exercise and Sport Science), The University of Western Australia, Perth, WA 6009, Australia.'}]","Applied physiology, nutrition, and metabolism = Physiologie appliquee, nutrition et metabolisme",['10.1139/apnm-2019-0672'] 3171,21303799,Response to influenza virus vaccination during chemotherapy in patients with breast cancer.,"BACKGROUND Patients receiving chemotherapy are at increased risk for influenza virus infection. Little is known about the preferred moment of vaccination during chemotherapy. PATIENTS AND METHODS Breast cancer patients received influenza vaccination during FEC (5-fluorouracil, epirubicin and cyclophosphamide)-containing chemotherapy regimens. Patients were randomised for early (day 4) or late (day 16) vaccination during the chemotherapy cycle. Influenza virus-specific antibody titres were determined before and 3 weeks after vaccination by haemagglutination inhibition. RESULTS We included 38 breast cancer patients (20 in the early and 18 in the late group) and 21 healthy controls. The overall patient group had significant lower responses to the vaccine compared with healthy controls. Patients vaccinated at day 4 tended to have higher antibody titres as compared with patients vaccinated at day 16, although the difference in post-vaccination titres is not statistically significant. Geometric mean titres post-vaccination for day 4 versus day 16 were 63.7 versus 29.5 (H3N2), 28.2 versus 19.6 (H1N1) and 29.8 versus 16.0 (B/Brisbane), respectively. CONCLUSIONS Patients on chemotherapy have significantly lower responses to influenza virus vaccination compared with healthy controls. Vaccination early during the chemotherapy cycle induces better responses than does vaccination at day 16 of the cycle. Follow-up studies are needed to confirm this effect.",2011,"Patients vaccinated at day 4 tended to have higher antibody titres as compared with patients vaccinated at day 16, although the difference in post-vaccination titres is not statistically significant.","['Breast cancer patients received', '38 breast cancer patients (20 in the early and 18 in the late group) and 21 healthy controls', 'patients with breast cancer']","['influenza virus vaccination during chemotherapy', 'influenza vaccination during FEC (5-fluorouracil, epirubicin and cyclophosphamide)-containing chemotherapy regimens', 'chemotherapy']","['Influenza virus-specific antibody titres', 'Geometric mean titres post-vaccination', 'antibody titres']","[{'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C4316910', 'cui_str': 'Influenzavirus'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0042200', 'cui_str': 'Influenza vaccination (procedure)'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0014582', 'cui_str': 'Epirubicin'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}]","[{'cui': 'C4316910', 'cui_str': 'Influenzavirus'}, {'cui': 'C0443640', 'cui_str': 'Specific antibody (substance)'}, {'cui': 'C0475208', 'cui_str': 'TITR'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C1287242', 'cui_str': 'Finding of antibody titer (finding)'}]",38.0,0.0355224,"Patients vaccinated at day 4 tended to have higher antibody titres as compared with patients vaccinated at day 16, although the difference in post-vaccination titres is not statistically significant.","[{'ForeName': 'A', 'Initials': 'A', 'LastName': 'Meerveld-Eggink', 'Affiliation': 'Department of Internal Medicine, St Antonius Hospital Nieuwegein, Nieuwegein. Electronic address: a.eggink@antoniusziekenhuis.nl.'}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'de Weerdt', 'Affiliation': 'Department of Internal Medicine, St Antonius Hospital Nieuwegein, Nieuwegein.'}, {'ForeName': 'A M T', 'Initials': 'AMT', 'LastName': 'van der Velden', 'Affiliation': 'Department of Internal Medicine, Tergooi Hospitals Blaricum, Blaricum.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Los', 'Affiliation': 'Department of Internal Medicine, St Antonius Hospital Nieuwegein, Nieuwegein.'}, {'ForeName': 'A W G', 'Initials': 'AWG', 'LastName': 'van der Velden', 'Affiliation': 'Department of Internal Medicine, Martini Hospital Groningen, Groningen.'}, {'ForeName': 'J M L', 'Initials': 'JML', 'LastName': 'Stouthard', 'Affiliation': 'Department of Internal Medicine, Maasstad Hospital Rotterdam, Rotterdam.'}, {'ForeName': 'M R', 'Initials': 'MR', 'LastName': 'Nijziel', 'Affiliation': 'Department of Internal Medicine, Máxima Medical Centre Eindhoven, Eindhoven.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Westerman', 'Affiliation': 'Department of Internal Medicine, Medical Centre Alkmaar, Alkmaar.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Beeker', 'Affiliation': 'Department of Internal Medicine, Spaarne Hospital Hoofddorp, Hoofddorp.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'van Beek', 'Affiliation': 'Department of Virology, Erasmus Medical Centre Rotterdam, Rotterdam.'}, {'ForeName': 'G F', 'Initials': 'GF', 'LastName': 'Rimmelzwaan', 'Affiliation': 'Department of Virology, Erasmus Medical Centre Rotterdam, Rotterdam.'}, {'ForeName': 'G T', 'Initials': 'GT', 'LastName': 'Rijkers', 'Affiliation': 'Department of Medical Microbiology and Immunology, St Antonius Hospital Nieuwegein, Nieuwegein.'}, {'ForeName': 'D H', 'Initials': 'DH', 'LastName': 'Biesma', 'Affiliation': 'Department of Internal Medicine, St Antonius Hospital Nieuwegein, Nieuwegein; Department of Internal Medicine, University Medical Centre Utrecht, Utrecht, the Netherlands.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdq728'] 3172,21343383,"Delta-9-tetrahydrocannabinol may palliate altered chemosensory perception in cancer patients: results of a randomized, double-blind, placebo-controlled pilot trial.","BACKGROUND A pilot study (NCT00316563) to determine if delta-9-tetrahydrocannabinol (THC) can improve taste and smell (chemosensory) perception as well as appetite, caloric intake, and quality of life (QOL) for cancer patients with chemosensory alterations. PATIENTS AND METHODS Adult advanced cancer patients, with poor appetite and chemosensory alterations, were recruited from two sites and randomized in a double-blinded manner to receive either THC (2.5 mg, Marinol(®); Solvay Pharma Inc., n = 24) or placebo oral capsules (n = 22) twice daily for 18 days. Twenty-one patients completed the trial. At baseline and posttreatment, patients completed a panel of patient-reported outcomes: Taste and Smell Survey, 3-day food record, appetite and macronutrient preference assessments, QOL questionnaire, and an interview. RESULTS THC and placebo groups were comparable at baseline. Compared with placebo, THC-treated patients reported improved (P = 0.026) and enhanced (P < 0.001) chemosensory perception and food 'tasted better' (P = 0.04). Premeal appetite (P = 0.05) and proportion of calories consumed as protein increased compared with placebo (P = 0.008). THC-treated patients reported increased quality of sleep (P = 0.025) and relaxation (P = 0.045). QOL scores and total caloric intake were improved in both THC and placebo groups. CONCLUSIONS THC may be useful in the palliation of chemosensory alterations and to improve food enjoyment for cancer patients.",2011,THC-treated patients reported increased quality of sleep (P = 0.025) and relaxation (P = 0.045).,"['Adult advanced cancer patients, with poor appetite and chemosensory alterations', 'cancer patients', 'cancer patients with chemosensory alterations']","['placebo', 'Delta-9-tetrahydrocannabinol', 'placebo oral capsules', 'delta-9-tetrahydrocannabinol', 'THC', 'placebo, THC']","['Premeal appetite', 'quality of sleep', 'outcomes: Taste and Smell Survey, 3-day food record, appetite and macronutrient preference assessments, QOL questionnaire, and an interview', 'food enjoyment', 'QOL scores and total caloric intake', 'taste and smell (chemosensory) perception as well as appetite, caloric intake, and quality of life (QOL', 'proportion of calories consumed as protein']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0877373', 'cui_str': 'Advanced cancer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0232462', 'cui_str': 'Decrease in appetite (finding)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0039663', 'cui_str': 'dronabinol'}, {'cui': 'C0991533', 'cui_str': 'Oral Capsule'}]","[{'cui': 'C0003618', 'cui_str': 'Appetite'}, {'cui': 'C0424563', 'cui_str': 'Quality of sleep (observable entity)'}, {'cui': 'C0039336', 'cui_str': 'Gustation'}, {'cui': 'C0998863', 'cui_str': 'Osmeridae'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}, {'cui': 'C2346926', 'cui_str': 'Macronutrient'}, {'cui': 'C0558295', 'cui_str': 'Preferences (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0006777', 'cui_str': 'Caloric Intake'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0034380'}, {'cui': 'C1879985', 'cui_str': 'calorie'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}]",,0.6139,THC-treated patients reported increased quality of sleep (P = 0.025) and relaxation (P = 0.045).,"[{'ForeName': 'T D', 'Initials': 'TD', 'LastName': 'Brisbois', 'Affiliation': 'Department of Agricultural, Food & Nutritional Science.'}, {'ForeName': 'I H', 'Initials': 'IH', 'LastName': 'de Kock', 'Affiliation': 'Division of Palliative Care Medicine, Department of Oncology, University of Alberta, Edmonton.'}, {'ForeName': 'S M', 'Initials': 'SM', 'LastName': 'Watanabe', 'Affiliation': 'Division of Palliative Care Medicine, Department of Oncology, University of Alberta, Edmonton.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Mirhosseini', 'Affiliation': 'Division of Palliative Care Medicine, Department of Oncology, University of Alberta, Edmonton.'}, {'ForeName': 'D C', 'Initials': 'DC', 'LastName': 'Lamoureux', 'Affiliation': 'Division of Palliative Care Medicine, Department of Oncology, University of Alberta, Edmonton.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Chasen', 'Affiliation': 'Division of Palliative Care Medicine, Department of Oncology, University of Ottawa, Ottawa.'}, {'ForeName': 'N', 'Initials': 'N', 'LastName': 'MacDonald', 'Affiliation': 'Cancer Nutrition and Rehabilitation Program, Department of Oncology, McGill University, Montreal, Canada.'}, {'ForeName': 'V E', 'Initials': 'VE', 'LastName': 'Baracos', 'Affiliation': 'Division of Palliative Care Medicine, Department of Oncology, University of Alberta, Edmonton.'}, {'ForeName': 'W V', 'Initials': 'WV', 'LastName': 'Wismer', 'Affiliation': 'Department of Agricultural, Food & Nutritional Science. Electronic address: wendy.wismer@ualberta.ca.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdq727'] 3173,32020044,Lenalidomide added to standard intensive treatment for older patients with AML and high-risk MDS.,"More effective treatment modalities are urgently needed in patients with acute myeloid leukemia (AML) of older age. We hypothesized that adding lenalidomide to intensive standard chemotherapy might improve their outcome. After establishing a safe lenalidomide, dose elderly patients with AML were randomly assigned in this randomized Phase 2 study (n = 222) to receive standard chemotherapy (""3 + 7"") with or without lenalidomide at a dose of 20 mg/day 1-21. In the second cycle, patients received cytarabine 1000 mg/m 2 twice daily on days 1-6 with or without lenalidomide (20 mg/day 1-21). The CR/CRi rates in the two arms were not different (69 vs. 66%). Event-free survival (EFS) at 36 months was 19% for the standard arm versus 21% for the lenalidomide arm and overall survival (OS) 35% vs. 30%, respectively. The frequencies and grade of adverse events were not significantly different between the treatment arms. Cardiovascular toxicities were rare and equally distributed between the arms. The results of the present study show that the addition of lenalidomide to standard remission induction chemotherapy does not improve the therapeutic outcome of older AML patients. This trial is registered as number NTR2294 in The NederlandsTrial Register (www.trialregister.nl).",2020,The frequencies and grade of adverse events were not significantly different between the treatment arms.,"['older AML patients', 'patients with acute myeloid leukemia (AML) of older age', 'elderly patients with AML', 'older patients with AML and high-risk MDS']","['Lenalidomide', 'cytarabine 1000\u2009mg/m 2 twice daily on days 1-6 with or without lenalidomide', 'standard chemotherapy (""3\u2009+\u20097"") with or without lenalidomide']","['frequencies and grade of adverse events', 'Event-free survival (EFS', 'CR/CRi rates', 'Cardiovascular toxicities', 'overall survival']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0023467', 'cui_str': 'Nonlymphoblastic Leukemia, Acute'}, {'cui': 'C1999167', 'cui_str': 'Old-age (finding)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0265219', 'cui_str': 'Lissencephaly Syndrome, Miller-Dieker'}]","[{'cui': 'C1144149', 'cui_str': 'lenalidomide'}, {'cui': 'C0010711', 'cui_str': 'Cytarabine'}, {'cui': 'C1883310', 'cui_str': '1000 (qualifier value)'}, {'cui': 'C0585361', 'cui_str': 'Twice a day (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C3179739', 'cui_str': '(LaCit2)3+'}]","[{'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",,0.103256,The frequencies and grade of adverse events were not significantly different between the treatment arms.,"[{'ForeName': 'G J', 'Initials': 'GJ', 'LastName': 'Ossenkoppele', 'Affiliation': 'Amsterdam University Medical Cente, location VUMC, Amsterdam, Netherlands. g.ossenkoppele@amsterdamumc.nl.'}, {'ForeName': 'D A', 'Initials': 'DA', 'LastName': 'Breems', 'Affiliation': 'Netwerk Antwerpen, Antwerp, Belgium.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Stuessi', 'Affiliation': 'Bellinzona-IOSI, Bellinzona, Switzerland.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'van Norden', 'Affiliation': 'HOVON Data Center, Erasmus MC- Department of Hematology, Rotterdam, The Netherlands.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Bargetzi', 'Affiliation': 'Aarau- Kantonsspital, Aarau, Switzerland.'}, {'ForeName': 'B J', 'Initials': 'BJ', 'LastName': 'Biemond', 'Affiliation': 'Amsterdam University Medical Center, location AMC, Amsterdam, Netherlands.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'A von dem Borne', 'Affiliation': 'Leiden University Medical Center, Leiden, Netherlands.'}, {'ForeName': 'Y', 'Initials': 'Y', 'LastName': 'Chalandon', 'Affiliation': 'University Hospital and University of Geneva, Genève, Switzerland.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Cloos', 'Affiliation': 'Amsterdam University Medical Cente, location VUMC, Amsterdam, Netherlands.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Deeren', 'Affiliation': 'Roeselare-AZ Delta, Roeselare, Belgium.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Fehr', 'Affiliation': 'St Gallen-Kantonnsspital, St. Gallen, Switzerland.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Gjertsen', 'Affiliation': 'Haukeland University Hospital, Bergen (N), Norway.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Graux', 'Affiliation': 'Yvoir-MontGodinne, Yvoir, Belgium.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Huls', 'Affiliation': 'University Medical Center, Groningen, Netherlands.'}, {'ForeName': 'J J J W', 'Initials': 'JJJW', 'LastName': 'Janssen', 'Affiliation': 'Amsterdam University Medical Cente, location VUMC, Amsterdam, Netherlands.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Jaspers', 'Affiliation': 'Hôpital Citadelle, Liège (B), Belgium.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Jongen-Lavrencic', 'Affiliation': 'Erasmus University Medical Center, Rotterdam, Netherlands.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'de Jongh', 'Affiliation': 'Dordrecht ASZ, Dordrecht, Netherlands.'}, {'ForeName': 'S K', 'Initials': 'SK', 'LastName': 'Klein', 'Affiliation': 'Meander Medical Center, Amersfoort, Netherlands.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'van der Klift', 'Affiliation': 'Amphia-Breda, Breda, Netherlands.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'van Marwijk Kooy', 'Affiliation': 'Isala Hospital, Zwolle, Netherlands.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Maertens', 'Affiliation': 'Hospital Gasthuisberg, Leuven (B), Belgium.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Micheaux', 'Affiliation': 'Center for Human Genetics, KU Leuven and University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'M W M', 'Initials': 'MWM', 'LastName': 'van der Poel', 'Affiliation': 'Maastricht University Medical Center, Maastricht, Netherlands.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'van Rhenen', 'Affiliation': 'UMC Utrecht, Utrecht, Netherlands.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Tick', 'Affiliation': 'MaximaMC Eindhoven, Eindhoven, Netherlands.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Valk', 'Affiliation': 'Hôpital Citadelle, Liège (B), Belgium.'}, {'ForeName': 'M C', 'Initials': 'MC', 'LastName': 'Vekemans', 'Affiliation': 'Hôpital St Luc, Bruxelles, Belgium.'}, {'ForeName': 'W J F M', 'Initials': 'WJFM', 'LastName': 'van der Velden', 'Affiliation': 'Radboudumc Nijmegen, Nijmegen, Netherlands.'}, {'ForeName': 'O', 'Initials': 'O', 'LastName': 'de Weerdt', 'Affiliation': 'St Antonius Hospital, Nieuwegein, Netherlands.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Pabst', 'Affiliation': 'Department of Oncology, University Hospital, Inselspital and University of Bern, Bern, Switzerland.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Manz', 'Affiliation': 'University Hospital, Zurich, Switzerland.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Löwenberg', 'Affiliation': 'Hôpital Citadelle, Liège (B), Belgium.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Leukemia,['10.1038/s41375-020-0725-0'] 3174,32020530,Cost-Neutral Optimization of Pazopanib Exposure by Splitting Intake Moments: A Prospective Pharmacokinetic Study in Cancer Patients.,"BACKGROUND AND OBJECTIVE Pazopanib is an oral tyrosine kinase inhibitor used in the treatment of renal cell carcinoma and soft-tissue sarcoma. At the approved dose of 800 mg once daily (QD), 16-20% of patients are being underdosed and at risk of decreased efficacy. This study aimed to show whether splitting intake moments, as a cost-neutral alternative to a dose increase, leads to an increased exposure. METHODS We performed a cross-over trial comparing the pharmacokinetics of pazopanib 800 mg QD with pazopanib 400 mg twice daily. Pharmacokinetic sampling was performed at steady-state for both dosing schedules. RESULTS Nine evaluable patients were included. At the 800 mg QD dosing schedule, median minimum plasma concentration (C min ), area under the concentration-time curve from 0 to 24 h (AUC 0-24h ), and maximum plasma concentration (C max ) were 23.2 mg/L (interquartile range 18.5-27.6), 773 mg h/L (557-1009), and 40.6 mg/L (36.4-56.4) compared with 41.6 mg/L (30.5-55.8, p = 0.004), 942 mg h/L (885-1419, p = 0.027), and 50.2 mg/L (46.8-72.5, p = 0.074) at 400 mg twice daily. One patient experienced a grade 3 event (i.e., diarrhea). CONCLUSIONS This study demonstrates that splitting intake moments of pazopanib leads to a 79% increase in C min , with acceptable tolerability. Therefore, this new dosing schedule offers a cost-neutral opportunity to optimize treatment in patients with low exposure. CLINICAL TRIAL REGISTRATION NL6137 ( http://www.trialregister.nl ).",2020,"At the 800 mg QD dosing schedule, median minimum plasma concentration (C min ), area under the concentration-time curve from 0 to 24 h (AUC 0-24h ), and maximum plasma concentration (C max ) were 23.2 mg/L (interquartile range 18.5-27.6), 773 mg ","['Nine evaluable patients were included', 'Cancer Patients', 'renal cell carcinoma and soft-tissue sarcoma', 'patients with low exposure']","['pazopanib 800\xa0mg QD with pazopanib', 'Pazopanib', 'Pazopanib Exposure by Splitting Intake Moments', 'pazopanib']","['maximum plasma concentration\xa0(C max ', 'grade 3 event (i.e., diarrhea', 'median minimum plasma concentration\xa0(C min ), area under the concentration-time curve']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0007134', 'cui_str': 'Nephroid Carcinoma'}, {'cui': 'C4551687', 'cui_str': 'Sarcoma of soft tissue (disorder)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}]","[{'cui': 'C1831796', 'cui_str': 'pazopanib'}, {'cui': 'C3844106', 'cui_str': 'Eight hundred'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}]","[{'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0441471', 'cui_str': 'Event (event)'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205134', 'cui_str': 'Curved (qualifier value)'}]",9.0,0.0638562,"At the 800 mg QD dosing schedule, median minimum plasma concentration (C min ), area under the concentration-time curve from 0 to 24 h (AUC 0-24h ), and maximum plasma concentration (C max ) were 23.2 mg/L (interquartile range 18.5-27.6), 773 mg ","[{'ForeName': 'Stefanie L', 'Initials': 'SL', 'LastName': 'Groenland', 'Affiliation': 'Division of Medical Oncology, Department of Clinical Pharmacology, The Netherlands Cancer Institute-Antoni van Leeuwenhoek, Plesmanlaan 121, 1066 CX, Amsterdam, The Netherlands. s.groenland@nki.nl.'}, {'ForeName': 'Ruben A G', 'Initials': 'RAG', 'LastName': 'van Eerden', 'Affiliation': 'Department of Medical Oncology, Erasmus MC Cancer Institute, Rotterdam, The Netherlands.'}, {'ForeName': 'Remy B', 'Initials': 'RB', 'LastName': 'Verheijen', 'Affiliation': 'Department of Pharmacy and Pharmacology, The Netherlands Cancer Institute-Antoni van Leeuwenhoek, Amsterdam, The Netherlands.'}, {'ForeName': 'Niels', 'Initials': 'N', 'LastName': 'de Vries', 'Affiliation': 'Department of Pharmacy and Pharmacology, The Netherlands Cancer Institute-Antoni van Leeuwenhoek, Amsterdam, The Netherlands.'}, {'ForeName': 'Bas', 'Initials': 'B', 'LastName': 'Thijssen', 'Affiliation': 'Department of Pharmacy and Pharmacology, The Netherlands Cancer Institute-Antoni van Leeuwenhoek, Amsterdam, The Netherlands.'}, {'ForeName': 'Hilde', 'Initials': 'H', 'LastName': 'Rosing', 'Affiliation': 'Department of Pharmacy and Pharmacology, The Netherlands Cancer Institute-Antoni van Leeuwenhoek, Amsterdam, The Netherlands.'}, {'ForeName': 'Jos H', 'Initials': 'JH', 'LastName': 'Beijnen', 'Affiliation': 'Department of Pharmacy and Pharmacology, The Netherlands Cancer Institute-Antoni van Leeuwenhoek, Amsterdam, The Netherlands.'}, {'ForeName': 'Stijn L W', 'Initials': 'SLW', 'LastName': 'Koolen', 'Affiliation': 'Department of Medical Oncology, Erasmus MC Cancer Institute, Rotterdam, The Netherlands.'}, {'ForeName': 'Ron H J', 'Initials': 'RHJ', 'LastName': 'Mathijssen', 'Affiliation': 'Department of Medical Oncology, Erasmus MC Cancer Institute, Rotterdam, The Netherlands.'}, {'ForeName': 'Alwin D R', 'Initials': 'ADR', 'LastName': 'Huitema', 'Affiliation': 'Department of Pharmacy and Pharmacology, The Netherlands Cancer Institute-Antoni van Leeuwenhoek, Amsterdam, The Netherlands.'}, {'ForeName': 'Neeltje', 'Initials': 'N', 'LastName': 'Steeghs', 'Affiliation': 'Division of Medical Oncology, Department of Clinical Pharmacology, The Netherlands Cancer Institute-Antoni van Leeuwenhoek, Plesmanlaan 121, 1066 CX, Amsterdam, The Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Clinical pharmacokinetics,['10.1007/s40262-020-00863-5'] 3175,31994254,Nicotine delivery and users' reactions to Juul compared with cigarettes and other e-cigarette products.,"AIMS To assess the pharmacokinetic (PK) profile of, and users' reactions to, Juul (59 mg nicotine/ml) as an indication of its therapeutic and dependence potential. DESIGN Cross-over, within-subjects study in which participants attended after overnight abstinence on separate sessions and smoked a cigarette or used Juul or eight other types of e-cigarettes (EC) ad libitum for 5 minutes. The Juul product used was the version available in the United States that has more nicotine in the e-liquid than the one available in the European Union. SETTING Laboratory setting in the United Kingdom. PARTICIPANTS Twenty dual users (smokers who also vape) provided data on Juul and cigarettes, with eight also providing data on other EC products. MEASUREMENTS At each session, number of puffs taken was counted during the 5-minute product use period and blood samples were taken at baseline and at 2, 4, 6, 8, 10 and 30 minutes after starting smoking/vaping and analysed for nicotine. Participants also monitored their urges to smoke and rated the products on a range of characteristics. FINDINGS Juul's PK profile was close to the PK profile of cigarettes [maximum concentration (C max ) = 20.4 versus 19.2 ng/ml; time to maximum concentration (T max ) = 4 versus 6 minutes; area under the curve (AUC): 307.9 versus 312.6, respectively]. Compared with other EC products, Juul had shorter T max [4 minutes, (IQR = 2.5-4.0) versus 6.3 minutes, (IQR = 4.7 - 8.1), P = 0.012] and higher C max (28.9 (SD = 15.6) versus 10.6 (SD = 5.5), P = 0.013) despite a lower number of puffs (12.5 (SD = 4.2) versus 17.0 (SD = 4.2), P = 0.084). Compared with other e-cigarette products, it also provided faster reduction of urges to smoke and obtained more favourable subjective ratings. CONCLUSION Juul's PK profile and user ratings suggest that it could be more effective than other EC products in helping smokers to quit smoking, but it may also have a higher potential to generate regular use in non-smokers.",2020,"Compared with other EC products, Juul had shorter T max [4 minutes, (IQR = 2.5-4.0) versus 6.3 minutes, (IQR = 4.7 - 8.1), P = 0.012] and higher C max (28.9 (SD = 15.6) versus 10.6 (SD = 5.5), P = 0.013) despite a lower number of puffs (12.5 (SD = 4.2) versus 17.0 (SD = 4.2), P = 0.084).","['Twenty dual users (smokers who also vape) provided data on Juul and cigarettes, with eight also providing data on other EC products']","['Nicotine', 'Juul (59\xa0mg nicotine/ml', 'overnight abstinence on separate sessions and smoked a cigarette or used Juul or eight other types of e-cigarettes (EC) ad libitum for 5\xa0minutes']",[],"[{'cui': 'C0337664', 'cui_str': 'Smoker'}, {'cui': 'C4083280', 'cui_str': 'Vaping'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}]","[{'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0439583', 'cui_str': 'Overnight (qualifier value)'}, {'cui': 'C0443299', 'cui_str': 'Separate (qualifier value)'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C3849993', 'cui_str': 'Electronic Cigarettes'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}]",[],,0.051452,"Compared with other EC products, Juul had shorter T max [4 minutes, (IQR = 2.5-4.0) versus 6.3 minutes, (IQR = 4.7 - 8.1), P = 0.012] and higher C max (28.9 (SD = 15.6) versus 10.6 (SD = 5.5), P = 0.013) despite a lower number of puffs (12.5 (SD = 4.2) versus 17.0 (SD = 4.2), P = 0.084).","[{'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Hajek', 'Affiliation': 'Health and Lifestyle Research Unit, Queen Mary University of London, London, UK.'}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Pittaccio', 'Affiliation': 'Health and Lifestyle Research Unit, Queen Mary University of London, London, UK.'}, {'ForeName': 'Francesca', 'Initials': 'F', 'LastName': 'Pesola', 'Affiliation': ""Faculty of Life Sciences and Medicine, King's College London, London, UK.""}, {'ForeName': 'Katie', 'Initials': 'K', 'LastName': 'Myers Smith', 'Affiliation': 'Health and Lifestyle Research Unit, Queen Mary University of London, London, UK.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Phillips-Waller', 'Affiliation': 'Health and Lifestyle Research Unit, Queen Mary University of London, London, UK.'}, {'ForeName': 'Dunja', 'Initials': 'D', 'LastName': 'Przulj', 'Affiliation': 'Health and Lifestyle Research Unit, Queen Mary University of London, London, UK.'}]","Addiction (Abingdon, England)",['10.1111/add.14936'] 3176,32013332,Desflurane is not inferior to sevoflurane in the occurrence of adverse respiratory events during laryngeal mask airway anesthesia: a non-inferiority randomized double-blinded controlled study.,"BACKGROUND Compared to sevoflurane, desflurane is less favorable to most anesthesiologists for laryngeal mask airway (LMA) anesthesia because desflurane has a pungent odor. This non-inferiority study aimed to determine whether desflurane is not worse than sevoflurane in triggering airway irritations during general anesthesia using LMA. METHODS Patients scheduled for elective surgery under LMA anesthesia were randomly allocated to receive either desflurane or sevoflurane for maintenance of anesthesia. After intravenous fentanyl, lidocaine and propofol administration followed by LMA insertion, 0.5-1.0 MAC of the volatile anesthetic in 50% N2O was maintained throughout the surgery. The primary outcome was the occurrence of perioperative adverse respiratory events. Other outcomes included recovery profiles, hemodynamic changes and postoperative complications. RESULTS One-hundred and ten patients per group completed the study without any serious complications, lost to follow-up, or protocol deviation. During awake LMA removal, patients in the desflurane group experienced lesser episodes of laryngospasm (risk difference, -7.3%; 95% CI, -12.7% to -1.9%; P=0.009) than those in the sevoflurane group. The emergence time and time to LMA removal were significantly shorter in the desflurane group. The quality of recovery indicated by an ability to self-transfer from bed to bed was significantly better after desflurane anesthesia. No difference between groups was found in a return of orientation and a readiness for post-anesthesia care unit discharge. CONCLUSIONS Desflurane is non-inferior to sevoflurane in the occurrence of laryngospasm at emergence after LMA anesthesia. The superiority of desflurane compared to sevoflurane with regards to respiratory complications requires further investigation.",2020,The quality of recovery indicated by an ability to self-transfer from bed to bed was significantly better after desflurane anesthesia.,"['Patients scheduled for elective surgery under LMA anesthesia', 'laryngeal mask airway anesthesia']","['fentanyl, lidocaine and propofol', 'desflurane or sevoflurane', 'sevoflurane', 'Desflurane', 'desflurane', 'sevoflurane, desflurane']","['episodes of laryngospasm', 'return of orientation and a readiness for post-anesthesia care unit discharge', 'emergence time and time to LMA removal', 'recovery profiles, hemodynamic changes and postoperative complications', 'serious complications', 'occurrence of perioperative adverse respiratory events']","[{'cui': 'C0030703', 'cui_str': 'Schedules, Patient'}, {'cui': 'C0206058', 'cui_str': 'Elective Surgical Procedures'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C0162645', 'cui_str': 'Laryngeal Mask Airway'}]","[{'cui': 'C0015846', 'cui_str': 'Fentanyl'}, {'cui': 'C0023660', 'cui_str': 'Lidocaine'}, {'cui': 'C0033487', 'cui_str': 'Propofol'}, {'cui': 'C0063252', 'cui_str': 'desflurane'}, {'cui': 'C0074414', 'cui_str': 'sevoflurane'}]","[{'cui': 'C0332189', 'cui_str': 'Episodes (qualifier value)'}, {'cui': 'C0023066', 'cui_str': 'Laryngospasm'}, {'cui': 'C0029266', 'cui_str': 'Cognitive Orientation'}, {'cui': 'C1318963', 'cui_str': 'Readiness'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0015252', 'cui_str': 'Removal - action (qualifier value)'}, {'cui': 'C0019010', 'cui_str': 'Hemodynamics'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C1320717', 'cui_str': 'Respiratory event'}]",,0.143643,The quality of recovery indicated by an ability to self-transfer from bed to bed was significantly better after desflurane anesthesia.,"[{'ForeName': 'Pathomporn', 'Initials': 'P', 'LastName': 'Pin-On', 'Affiliation': 'Department of Anesthesiology, Faculty of Medicine, Maharaj Nakorn Chiang Mai Hospital, Chiang Mai University, Chiang Mai, Thailand.'}, {'ForeName': 'Prangmalee', 'Initials': 'P', 'LastName': 'Leurcharusmee', 'Affiliation': 'Department of Anesthesiology, Faculty of Medicine, Maharaj Nakorn Chiang Mai Hospital, Chiang Mai University, Chiang Mai, Thailand - prangmalee.l@cmu.ac.th.'}, {'ForeName': 'Suwannee', 'Initials': 'S', 'LastName': 'Tanasungnuchit', 'Affiliation': 'Department of Anesthesiology, Faculty of Medicine, Maharaj Nakorn Chiang Mai Hospital, Chiang Mai University, Chiang Mai, Thailand.'}, {'ForeName': 'Katekanog', 'Initials': 'K', 'LastName': 'Srivita', 'Affiliation': 'Department of Anesthesiology, Faculty of Medicine, Maharaj Nakorn Chiang Mai Hospital, Chiang Mai University, Chiang Mai, Thailand.'}, {'ForeName': 'Parichad', 'Initials': 'P', 'LastName': 'Khunwittaya', 'Affiliation': 'Department of Anesthesiology, Faculty of Medicine, Maharaj Nakorn Chiang Mai Hospital, Chiang Mai University, Chiang Mai, Thailand.'}]",Minerva anestesiologica,['10.23736/S0375-9393.20.14202-0'] 3177,32000725,STUDY PROTOCOL: EXPOSURE IN VIRTUAL REALITY FOR SOCIAL ANXIETY DISORDER - a randomized controlled superiority trial comparing cognitive behavioral therapy with virtual reality based exposure to cognitive behavioral therapy with in vivo exposure.,"BACKGROUND Social Anxiety Disorder (SAD) is characterized by an intense fear of negative judgement by others. Cognitive Behavioral Therapy (CBT) is recommended for treatment, but a substantial part of individuals with SAD either do not seek treatment or drop-out. CBT with Virtual Reality (VR)-based exposure has several advantages compared to traditional exposure methods, mainly due to increased control of situational elements. The aim of the current study is to develop a CBT program containing VR-based exposure. The intervention is targeted to adult patients suffering from SAD and treatment effect will be assessed by changes in SAD symptoms. METHODS This article describes the study protocol of a Randomized Controlled Trial with three arms: 1) CBT with VR exposure based on 360° videos 2) CBT with in vivo exposure and 3) VR relaxation therapy. There will be 30 participants in each arm with a crossover at the end of the treatment period during which the participants in the third group will be randomly re-allocated to one of the two former groups. The treatment program consists of 10 weekly individual sessions with a psychologist, and a six month follow-up consisting of a questionnaire. The primary outcome measure is reduction in SAD symptoms which will be assessed with the Social Interaction Anxiety Scale (SIAS). DISCUSSION There are currently no published studies on CBT with VR exposure based on 360° videos for SAD treatment. Furthermore, the current study will be the first Danish SAD treatment program that includes VR technology. TRIAL REGISTRATION clinicaltrials.gov (NCT03973541) June 3rd 2019.",2020,"The primary outcome measure is reduction in SAD symptoms which will be assessed with the Social Interaction Anxiety Scale (SIAS). ",[],"['CBT with VR exposure based on 360° videos\xa02) CBT with in vivo exposure and 3) VR relaxation therapy', 'Cognitive Behavioral Therapy (CBT', 'cognitive behavioral therapy with virtual reality based exposure to cognitive behavioral therapy', 'CBT with Virtual Reality (VR)-based exposure']","['reduction in SAD symptoms', 'Social Interaction Anxiety Scale (SIAS']",[],"[{'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C4319607', 'cui_str': '360 (qualifier value)'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0282333', 'cui_str': 'Relaxation Therapy'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C0332157', 'cui_str': 'Exposure to (contextual qualifier) (qualifier value)'}]","[{'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0037420', 'cui_str': 'Social Interaction'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0222045'}]",,0.0238137,"The primary outcome measure is reduction in SAD symptoms which will be assessed with the Social Interaction Anxiety Scale (SIAS). ","[{'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Clemmensen', 'Affiliation': 'Center for Telepsychiatry, Mental Health Services in the Region of Southern, Copenhagen, Denmark. lars.clemmensen@rsyd.dk.'}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Bouchard', 'Affiliation': 'Department of Psychoeducation and Psychology, University du Québec en Outaouais, Gatineau, Canada.'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Rasmussen', 'Affiliation': 'Center for Telepsychiatry, Mental Health Services in the Region of Southern, Copenhagen, Denmark.'}, {'ForeName': 'Trine Theresa', 'Initials': 'TT', 'LastName': 'Holmberg', 'Affiliation': 'Center for Telepsychiatry, Mental Health Services in the Region of Southern, Copenhagen, Denmark.'}, {'ForeName': 'Jakob Hyldig', 'Initials': 'JH', 'LastName': 'Nielsen', 'Affiliation': 'Center for Telepsychiatry, Mental Health Services in the Region of Southern, Copenhagen, Denmark.'}, {'ForeName': 'Jens Richardt Møllegaard', 'Initials': 'JRM', 'LastName': 'Jepsen', 'Affiliation': 'Center for Clinical Intervention and Neuropsychiatric Schizophrenia Research (CINS) and Center for Neuropsychiatric Schizophrenia Research (CNSR), Mental Health Centre Glostrup, University of Copenhagen, Glostrup, Denmark.'}, {'ForeName': 'Mia Beck', 'Initials': 'MB', 'LastName': 'Lichtenstein', 'Affiliation': 'Center for Telepsychiatry, Mental Health Services in the Region of Southern, Copenhagen, Denmark.'}]",BMC psychiatry,['10.1186/s12888-020-2453-4'] 3178,18385198,Temsirolimus safety profile and management of toxic effects in patients with advanced renal cell carcinoma and poor prognostic features.,"BACKGROUND Temsirolimus, a novel inhibitor of mammalian target of rapamycin, has demonstrated prolonged overall survival and progression-free survival compared with interferon alfa (IFN) in patients with advanced renal cell carcinoma (RCC) and poor prognostic features. Adverse events (AEs) of any causality were previously reported, but AEs that were deemed temsirolimus related are of particular relevance for poor-risk patients and for defining mammalian target of rapamycin inhibitor-specific side-effects. PATIENTS AND METHODS Patients with advanced RCC, no prior systemic therapy, and three or more of six poor-risk factors were randomly assigned to one of three groups: (i) IFN s.c. up to 18 MU thrice weekly, (ii) temsirolimus i.v. 25 mg weekly, or (iii) temsirolimus i.v. 15 mg weekly plus interferon s.c. 6 MU thrice weekly. RESULTS Among 208 patients, the most common temsirolimus-related grades 3-4 AEs were anemia (13%), hyperglycemia (9%), and asthenia (8%). Grades 3-4 hypercholesterolemia (1%), hypertriglyceridemia (3%), and hypophosphatemia (4%) were also seen. Although pneumonitis occurred infrequently, vigilance for its development is needed. Guidelines for management of toxic effects are presented on the basis of available clinical experience. CONCLUSIONS Temsirolimus-related grades 3-4 AEs were primarily metabolic in nature and easily controlled medically. In general, these did not negatively impact patient quality of life.",2008,"In general, these did not negatively impact patient quality of life.","['patients with advanced renal cell carcinoma (RCC', '208 patients', 'Patients with advanced RCC, no prior systemic therapy, and three or more of six poor-risk factors', 'patients with advanced renal cell carcinoma and poor prognostic features']",['interferon alfa (IFN'],"['hyperglycemia', 'hypertriglyceridemia', 'anemia', 'overall survival and progression-free survival', 'toxic effects', 'asthenia', 'hypophosphatemia']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0007134', 'cui_str': 'Nephroid Carcinoma'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}]","[{'cui': 'C0002199', 'cui_str': 'Interferon, Lymphoblastoid'}]","[{'cui': 'C0020456', 'cui_str': 'Hyperglycemia'}, {'cui': 'C0020557', 'cui_str': 'Hypertriglyceridemia'}, {'cui': 'C0002871', 'cui_str': 'Anemia'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0004093', 'cui_str': 'Asthenia'}, {'cui': 'C0085682', 'cui_str': 'Hypophosphatemia'}]",208.0,0.033408,"In general, these did not negatively impact patient quality of life.","[{'ForeName': 'J', 'Initials': 'J', 'LastName': 'Bellmunt', 'Affiliation': 'Oncology Department, University Hospital del Mar, Barcelona, Spain. Electronic address: jbellmunt@imas.imim.es.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Szczylik', 'Affiliation': 'Klinika Onkologii Wojskowy Instytut Medyczny, Warszawa, Poland.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Feingold', 'Affiliation': 'Wyeth Research, Cambridge, MA, 02140 USA.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Strahs', 'Affiliation': 'Wyeth Research, Cambridge, MA, 02140 USA.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Berkenblit', 'Affiliation': 'Wyeth Research, Cambridge, MA, 02140 USA.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdn066'] 3179,18385202,"Extracapsular tumor spread and the risk of local, axillary and supraclavicular recurrence in node-positive, premenopausal patients with breast cancer.","BACKGROUND Extracapsular tumor spread (ECS) has been identified as a possible risk factor for breast cancer recurrence, but controversy exists regarding its role in decision making for regional radiotherapy. This study evaluates ECS as a predictor of local, axillary, and supraclavicular recurrence. PATIENTS AND METHODS International Breast Cancer Study Group Trial VI accrued 1475 eligible pre- and perimenopausal women with node-positive breast cancer who were randomly assigned to receive three to nine courses of classical combination chemotherapy with cyclophosphamide, methotrexate, and fluorouracil. ECS status was determined retrospectively in 933 patients based on review of pathology reports. Cumulative incidence and hazard ratios (HRs) were estimated using methods for competing risks analysis. Adjustment factors included treatment group and baseline patient and tumor characteristics. The median follow-up was 14 years. RESULTS In univariable analysis, ECS was significantly associated with supraclavicular recurrence (HR = 1.96; 95% confidence interval 1.23-3.13; P = 0.005). HRs for local and axillary recurrence were 1.38 (P = 0.06) and 1.81 (P = 0.11), respectively. Following adjustment for number of lymph node metastases and other baseline prognostic factors, ECS was not significantly associated with any of the three recurrence types studied. CONCLUSIONS Our results indicate that the decision for additional regional radiotherapy should not be based solely on the presence of ECS.",2008,"In univariable analysis, ECS was significantly associated with supraclavicular recurrence (HR = 1.96; 95% confidence interval 1.23-3.13; P = 0.005).","['premenopausal patients with breast cancer', '933 patients based on review of pathology reports', '1475 eligible pre- and perimenopausal women with node-positive breast cancer']","['classical combination chemotherapy with cyclophosphamide, methotrexate, and fluorouracil', 'ECS', 'Extracapsular tumor spread (ECS']","['HRs for local and axillary recurrence', 'supraclavicular recurrence', 'Cumulative incidence and hazard ratios (HRs', 'Extracapsular tumor spread and the risk of local, axillary and supraclavicular recurrence']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0699752', 'cui_str': 'Review of (contextual qualifier) (qualifier value)'}, {'cui': 'C0807321', 'cui_str': 'Pathology report (record artifact)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C3839366', 'cui_str': 'Perimenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C3160887', 'cui_str': 'Node-positive breast cancer'}]","[{'cui': 'C0443177', 'cui_str': 'Classical (qualifier value)'}, {'cui': 'C0013218', 'cui_str': 'Combination Drug Therapy'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0332261', 'cui_str': 'Spread (attribute)'}]","[{'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C0004454', 'cui_str': 'Axilla'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0589496', 'cui_str': 'Supraclavicular approach (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0332261', 'cui_str': 'Spread (attribute)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",,0.168059,"In univariable analysis, ECS was significantly associated with supraclavicular recurrence (HR = 1.96; 95% confidence interval 1.23-3.13; P = 0.005).","[{'ForeName': 'G', 'Initials': 'G', 'LastName': 'Gruber', 'Affiliation': 'Institut für Radiotherapie, Klinik Hirslanden and Swiss Group for Clinical Cancer Research (SAKK), Zurich, Switzerland. Electronic address: guenther.gruber@hirslanden.ch.'}, {'ForeName': 'B F', 'Initials': 'BF', 'LastName': 'Cole', 'Affiliation': 'International Breast Cancer Study Group Statistical Center, Boston, MA and Department of Mathematics and Statistics, University of Vermont, Burlington, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Castiglione-Gertsch', 'Affiliation': 'International Breast Cancer Study Group (IBCSG) Coordinating Center, Bern, Switzerland.'}, {'ForeName': 'S B', 'Initials': 'SB', 'LastName': 'Holmberg', 'Affiliation': 'Department of Surgery, Sahlgrenska University Hospital, Göteborg, Sweden.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Lindtner', 'Affiliation': 'The Institute of Oncology, Ljubljana, Slovenia.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Golouh', 'Affiliation': 'The Institute of Oncology, Ljubljana, Slovenia.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Collins', 'Affiliation': 'Department of Surgery, The Royal Melbourne Hospital, Melbourne, Australia.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Crivellari', 'Affiliation': 'Centro di Riferimento Oncologico, Aviano, Italy.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Thürlimann', 'Affiliation': 'Senology Center of Eastern Switzerland, Kantonsspital and SAKK, St Gallen, Switzerland.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Simoncini', 'Affiliation': 'Oncologia Medica-Spedali Civili, Brescia, Italy.'}, {'ForeName': 'M F', 'Initials': 'MF', 'LastName': 'Fey', 'Affiliation': 'Department of Medical Oncology, Inselspital and SAKK, Bern, Switzerland.'}, {'ForeName': 'R D', 'Initials': 'RD', 'LastName': 'Gelber', 'Affiliation': 'IBCSG Statistical Center, Dana-Farber Cancer Institute, Frontier Science and Technology Research Foundation, Harvard School of Public Health, Boston, MA, USA.'}, {'ForeName': 'A S', 'Initials': 'AS', 'LastName': 'Coates', 'Affiliation': 'International Breast Cancer Study Group, Bern, Switzerland and University of Sydney, Sydney, Australia.'}, {'ForeName': 'K N', 'Initials': 'KN', 'LastName': 'Price', 'Affiliation': 'IBCSG Statistical Center, Frontier Science and Technology Research Foundation, Boston, MA, USA.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Goldhirsch', 'Affiliation': 'Oncology Institute of Southern Switzerland, Lugano, Switzerland and European Institute of Oncology, Milan, Italy.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Viale', 'Affiliation': 'Division of Pathology and Laboratory Medicine, European Institute of Oncology and University of Milan, Milan, Italy.'}, {'ForeName': 'B A', 'Initials': 'BA', 'LastName': 'Gusterson', 'Affiliation': 'Division of Cancer Sciences and Molecular Pathology, Faculty of Medicine, Glasgow University, Glasgow, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdn123'] 3180,31314966,HIV Testing and Treatment with the Use of a Community Health Approach in Rural Africa.,"BACKGROUND Universal antiretroviral therapy (ART) with annual population testing and a multidisease, patient-centered strategy could reduce new human immunodeficiency virus (HIV) infections and improve community health. METHODS We randomly assigned 32 rural communities in Uganda and Kenya to baseline HIV and multidisease testing and national guideline-restricted ART (control group) or to baseline testing plus annual testing, eligibility for universal ART, and patient-centered care (intervention group). The primary end point was the cumulative incidence of HIV infection at 3 years. Secondary end points included viral suppression, death, tuberculosis, hypertension control, and the change in the annual incidence of HIV infection (which was evaluated in the intervention group only). RESULTS A total of 150,395 persons were included in the analyses. Population-level viral suppression among 15,399 HIV-infected persons was 42% at baseline and was higher in the intervention group than in the control group at 3 years (79% vs. 68%; relative prevalence, 1.15; 95% confidence interval [CI], 1.11 to 1.20). The annual incidence of HIV infection in the intervention group decreased by 32% over 3 years (from 0.43 to 0.31 cases per 100 person-years; relative rate, 0.68; 95% CI, 0.56 to 0.84). However, the 3-year cumulative incidence (704 incident HIV infections) did not differ significantly between the intervention group and the control group (0.77% and 0.81%, respectively; relative risk, 0.95; 95% CI, 0.77 to 1.17). Among HIV-infected persons, the risk of death by year 3 was 3% in the intervention group and 4% in the control group (0.99 vs. 1.29 deaths per 100 person-years; relative risk, 0.77; 95% CI, 0.64 to 0.93). The risk of HIV-associated tuberculosis or death by year 3 among HIV-infected persons was 4% in the intervention group and 5% in the control group (1.19 vs. 1.50 events per 100 person-years; relative risk, 0.79; 95% CI, 0.67 to 0.94). At 3 years, 47% of adults with hypertension in the intervention group and 37% in the control group had hypertension control (relative prevalence, 1.26; 95% CI, 1.15 to 1.39). CONCLUSIONS Universal HIV treatment did not result in a significantly lower incidence of HIV infection than standard care, probably owing to the availability of comprehensive baseline HIV testing and the rapid expansion of ART eligibility in the control group. (Funded by the National Institutes of Health and others; SEARCH ClinicalTrials.gov number, NCT01864603.).",2019,"However, the 3-year cumulative incidence (704 incident HIV infections) did not differ significantly between the intervention group and the control group (0.77% and 0.81%, respectively; relative risk, 0.95; 95% CI, 0.77 to 1.17).","['150,395 persons', 'Rural Africa']","['Uganda and Kenya to baseline HIV and multidisease testing and national guideline-restricted ART (control group) or to baseline testing plus annual testing, eligibility for universal ART, and patient-centered care (intervention group']","['annual incidence of HIV infection', 'HIV infection', 'risk of HIV-associated tuberculosis or death', 'risk of death', 'hypertension control', 'viral suppression, death, tuberculosis, hypertension control, and the change in the annual incidence of HIV infection', '3-year cumulative incidence', 'cumulative incidence of HIV infection', 'Population-level viral suppression']","[{'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0001737', 'cui_str': 'Africa'}]","[{'cui': 'C0041573', 'cui_str': 'Republic of Uganda'}, {'cui': 'C0022558', 'cui_str': 'Republic of Kenya'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0220845', 'cui_str': 'guidelines'}, {'cui': 'C0443288', 'cui_str': 'Restricted (qualifier value)'}, {'cui': 'C0003826', 'cui_str': 'Arts'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}, {'cui': 'C0175671', 'cui_str': 'Universal (qualifier value)'}, {'cui': 'C0243024', 'cui_str': 'Patient-Centered Care'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0019693', 'cui_str': 'T-Lymphotropic Virus Type III Infections, Human'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0041296', 'cui_str': 'Mycobacterium tuberculosis Infection'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression (disorder)'}, {'cui': 'C0025320', 'cui_str': 'Change of Life, Female'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",32.0,0.218292,"However, the 3-year cumulative incidence (704 incident HIV infections) did not differ significantly between the intervention group and the control group (0.77% and 0.81%, respectively; relative risk, 0.95; 95% CI, 0.77 to 1.17).","[{'ForeName': 'Diane V', 'Initials': 'DV', 'LastName': 'Havlir', 'Affiliation': 'From the Division of HIV, Infectious Diseases, and Global Medicine, Department of Medicine (D.V.H., T.D.C., T.L., G.C., V.J., D.B., K.S., C.K., L.B., C.M.), the Division of Prevention Science, Department of Medicine (E.D.C., S.B.S., A.P.), the Department of Obstetrics, Gynecology, and Reproductive Sciences (C.S.C., R.B., M.G., C.R.C.), and the Division of Infectious Diseases, Department of Pediatrics (T.R.), University of California, San Francisco, and the San Francisco Department of Public Health (Y.-H.C.), San Francisco, the Division of Epidemiology and Biostatistics, the School of Public Health, University of California, Berkeley (J.S., M.L., M.P.), and Gilead Sciences, Foster City (J.F.R.) - all in California; the School of Public Health and Health Sciences, University of Massachusetts, Amherst (L.B.B.); the Infectious Diseases Research Collaboration (D.K., J. Kabami, M.A., E.S., D.M.B., F.M., A.O., H.N., J. Kironde, S.O., G.L.) and the School of Medicine, Makerere University (M.R.K.), Kampala, Uganda; Kenya Medical Research Institute, Nairobi (J. Ayieko, N.S., K.K., W.O., J. Achando, B.A., E.M.W., P.O., E.B.); Perelman School of Medicine, University of Pennsylvania, Philadelphia (H.T.); and the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD (M.B.).'}, {'ForeName': 'Laura B', 'Initials': 'LB', 'LastName': 'Balzer', 'Affiliation': 'From the Division of HIV, Infectious Diseases, and Global Medicine, Department of Medicine (D.V.H., T.D.C., T.L., G.C., V.J., D.B., K.S., C.K., L.B., C.M.), the Division of Prevention Science, Department of Medicine (E.D.C., S.B.S., A.P.), the Department of Obstetrics, Gynecology, and Reproductive Sciences (C.S.C., R.B., M.G., C.R.C.), and the Division of Infectious Diseases, Department of Pediatrics (T.R.), University of California, San Francisco, and the San Francisco Department of Public Health (Y.-H.C.), San Francisco, the Division of Epidemiology and Biostatistics, the School of Public Health, University of California, Berkeley (J.S., M.L., M.P.), and Gilead Sciences, Foster City (J.F.R.) - all in California; the School of Public Health and Health Sciences, University of Massachusetts, Amherst (L.B.B.); the Infectious Diseases Research Collaboration (D.K., J. Kabami, M.A., E.S., D.M.B., F.M., A.O., H.N., J. Kironde, S.O., G.L.) and the School of Medicine, Makerere University (M.R.K.), Kampala, Uganda; Kenya Medical Research Institute, Nairobi (J. Ayieko, N.S., K.K., W.O., J. Achando, B.A., E.M.W., P.O., E.B.); Perelman School of Medicine, University of Pennsylvania, Philadelphia (H.T.); and the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD (M.B.).'}, {'ForeName': 'Edwin D', 'Initials': 'ED', 'LastName': 'Charlebois', 'Affiliation': 'From the Division of HIV, Infectious Diseases, and Global Medicine, Department of Medicine (D.V.H., T.D.C., T.L., G.C., V.J., D.B., K.S., C.K., L.B., C.M.), the Division of Prevention Science, Department of Medicine (E.D.C., S.B.S., A.P.), the Department of Obstetrics, Gynecology, and Reproductive Sciences (C.S.C., R.B., M.G., C.R.C.), and the Division of Infectious Diseases, Department of Pediatrics (T.R.), University of California, San Francisco, and the San Francisco Department of Public Health (Y.-H.C.), San Francisco, the Division of Epidemiology and Biostatistics, the School of Public Health, University of California, Berkeley (J.S., M.L., M.P.), and Gilead Sciences, Foster City (J.F.R.) - all in California; the School of Public Health and Health Sciences, University of Massachusetts, Amherst (L.B.B.); the Infectious Diseases Research Collaboration (D.K., J. Kabami, M.A., E.S., D.M.B., F.M., A.O., H.N., J. Kironde, S.O., G.L.) and the School of Medicine, Makerere University (M.R.K.), Kampala, Uganda; Kenya Medical Research Institute, Nairobi (J. Ayieko, N.S., K.K., W.O., J. Achando, B.A., E.M.W., P.O., E.B.); Perelman School of Medicine, University of Pennsylvania, Philadelphia (H.T.); and the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD (M.B.).'}, {'ForeName': 'Tamara D', 'Initials': 'TD', 'LastName': 'Clark', 'Affiliation': 'From the Division of HIV, Infectious Diseases, and Global Medicine, Department of Medicine (D.V.H., T.D.C., T.L., G.C., V.J., D.B., K.S., C.K., L.B., C.M.), the Division of Prevention Science, Department of Medicine (E.D.C., S.B.S., A.P.), the Department of Obstetrics, Gynecology, and Reproductive Sciences (C.S.C., R.B., M.G., C.R.C.), and the Division of Infectious Diseases, Department of Pediatrics (T.R.), University of California, San Francisco, and the San Francisco Department of Public Health (Y.-H.C.), San Francisco, the Division of Epidemiology and Biostatistics, the School of Public Health, University of California, Berkeley (J.S., M.L., M.P.), and Gilead Sciences, Foster City (J.F.R.) - all in California; the School of Public Health and Health Sciences, University of Massachusetts, Amherst (L.B.B.); the Infectious Diseases Research Collaboration (D.K., J. Kabami, M.A., E.S., D.M.B., F.M., A.O., H.N., J. Kironde, S.O., G.L.) and the School of Medicine, Makerere University (M.R.K.), Kampala, Uganda; Kenya Medical Research Institute, Nairobi (J. Ayieko, N.S., K.K., W.O., J. Achando, B.A., E.M.W., P.O., E.B.); Perelman School of Medicine, University of Pennsylvania, Philadelphia (H.T.); and the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD (M.B.).'}, {'ForeName': 'Dalsone', 'Initials': 'D', 'LastName': 'Kwarisiima', 'Affiliation': 'From the Division of HIV, Infectious Diseases, and Global Medicine, Department of Medicine (D.V.H., T.D.C., T.L., G.C., V.J., D.B., K.S., C.K., L.B., C.M.), the Division of Prevention Science, Department of Medicine (E.D.C., S.B.S., A.P.), the Department of Obstetrics, Gynecology, and Reproductive Sciences (C.S.C., R.B., M.G., C.R.C.), and the Division of Infectious Diseases, Department of Pediatrics (T.R.), University of California, San Francisco, and the San Francisco Department of Public Health (Y.-H.C.), San Francisco, the Division of Epidemiology and Biostatistics, the School of Public Health, University of California, Berkeley (J.S., M.L., M.P.), and Gilead Sciences, Foster City (J.F.R.) - all in California; the School of Public Health and Health Sciences, University of Massachusetts, Amherst (L.B.B.); the Infectious Diseases Research Collaboration (D.K., J. Kabami, M.A., E.S., D.M.B., F.M., A.O., H.N., J. Kironde, S.O., G.L.) and the School of Medicine, Makerere University (M.R.K.), Kampala, Uganda; Kenya Medical Research Institute, Nairobi (J. Ayieko, N.S., K.K., W.O., J. Achando, B.A., E.M.W., P.O., E.B.); Perelman School of Medicine, University of Pennsylvania, Philadelphia (H.T.); and the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD (M.B.).'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Ayieko', 'Affiliation': 'From the Division of HIV, Infectious Diseases, and Global Medicine, Department of Medicine (D.V.H., T.D.C., T.L., G.C., V.J., D.B., K.S., C.K., L.B., C.M.), the Division of Prevention Science, Department of Medicine (E.D.C., S.B.S., A.P.), the Department of Obstetrics, Gynecology, and Reproductive Sciences (C.S.C., R.B., M.G., C.R.C.), and the Division of Infectious Diseases, Department of Pediatrics (T.R.), University of California, San Francisco, and the San Francisco Department of Public Health (Y.-H.C.), San Francisco, the Division of Epidemiology and Biostatistics, the School of Public Health, University of California, Berkeley (J.S., M.L., M.P.), and Gilead Sciences, Foster City (J.F.R.) - all in California; the School of Public Health and Health Sciences, University of Massachusetts, Amherst (L.B.B.); the Infectious Diseases Research Collaboration (D.K., J. Kabami, M.A., E.S., D.M.B., F.M., A.O., H.N., J. Kironde, S.O., G.L.) and the School of Medicine, Makerere University (M.R.K.), Kampala, Uganda; Kenya Medical Research Institute, Nairobi (J. Ayieko, N.S., K.K., W.O., J. Achando, B.A., E.M.W., P.O., E.B.); Perelman School of Medicine, University of Pennsylvania, Philadelphia (H.T.); and the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD (M.B.).'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Kabami', 'Affiliation': 'From the Division of HIV, Infectious Diseases, and Global Medicine, Department of Medicine (D.V.H., T.D.C., T.L., G.C., V.J., D.B., K.S., C.K., L.B., C.M.), the Division of Prevention Science, Department of Medicine (E.D.C., S.B.S., A.P.), the Department of Obstetrics, Gynecology, and Reproductive Sciences (C.S.C., R.B., M.G., C.R.C.), and the Division of Infectious Diseases, Department of Pediatrics (T.R.), University of California, San Francisco, and the San Francisco Department of Public Health (Y.-H.C.), San Francisco, the Division of Epidemiology and Biostatistics, the School of Public Health, University of California, Berkeley (J.S., M.L., M.P.), and Gilead Sciences, Foster City (J.F.R.) - all in California; the School of Public Health and Health Sciences, University of Massachusetts, Amherst (L.B.B.); the Infectious Diseases Research Collaboration (D.K., J. Kabami, M.A., E.S., D.M.B., F.M., A.O., H.N., J. Kironde, S.O., G.L.) and the School of Medicine, Makerere University (M.R.K.), Kampala, Uganda; Kenya Medical Research Institute, Nairobi (J. Ayieko, N.S., K.K., W.O., J. Achando, B.A., E.M.W., P.O., E.B.); Perelman School of Medicine, University of Pennsylvania, Philadelphia (H.T.); and the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD (M.B.).'}, {'ForeName': 'Norton', 'Initials': 'N', 'LastName': 'Sang', 'Affiliation': 'From the Division of HIV, Infectious Diseases, and Global Medicine, Department of Medicine (D.V.H., T.D.C., T.L., G.C., V.J., D.B., K.S., C.K., L.B., C.M.), the Division of Prevention Science, Department of Medicine (E.D.C., S.B.S., A.P.), the Department of Obstetrics, Gynecology, and Reproductive Sciences (C.S.C., R.B., M.G., C.R.C.), and the Division of Infectious Diseases, Department of Pediatrics (T.R.), University of California, San Francisco, and the San Francisco Department of Public Health (Y.-H.C.), San Francisco, the Division of Epidemiology and Biostatistics, the School of Public Health, University of California, Berkeley (J.S., M.L., M.P.), and Gilead Sciences, Foster City (J.F.R.) - all in California; the School of Public Health and Health Sciences, University of Massachusetts, Amherst (L.B.B.); the Infectious Diseases Research Collaboration (D.K., J. Kabami, M.A., E.S., D.M.B., F.M., A.O., H.N., J. Kironde, S.O., G.L.) and the School of Medicine, Makerere University (M.R.K.), Kampala, Uganda; Kenya Medical Research Institute, Nairobi (J. Ayieko, N.S., K.K., W.O., J. Achando, B.A., E.M.W., P.O., E.B.); Perelman School of Medicine, University of Pennsylvania, Philadelphia (H.T.); and the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD (M.B.).'}, {'ForeName': 'Teri', 'Initials': 'T', 'LastName': 'Liegler', 'Affiliation': 'From the Division of HIV, Infectious Diseases, and Global Medicine, Department of Medicine (D.V.H., T.D.C., T.L., G.C., V.J., D.B., K.S., C.K., L.B., C.M.), the Division of Prevention Science, Department of Medicine (E.D.C., S.B.S., A.P.), the Department of Obstetrics, Gynecology, and Reproductive Sciences (C.S.C., R.B., M.G., C.R.C.), and the Division of Infectious Diseases, Department of Pediatrics (T.R.), University of California, San Francisco, and the San Francisco Department of Public Health (Y.-H.C.), San Francisco, the Division of Epidemiology and Biostatistics, the School of Public Health, University of California, Berkeley (J.S., M.L., M.P.), and Gilead Sciences, Foster City (J.F.R.) - all in California; the School of Public Health and Health Sciences, University of Massachusetts, Amherst (L.B.B.); the Infectious Diseases Research Collaboration (D.K., J. Kabami, M.A., E.S., D.M.B., F.M., A.O., H.N., J. Kironde, S.O., G.L.) and the School of Medicine, Makerere University (M.R.K.), Kampala, Uganda; Kenya Medical Research Institute, Nairobi (J. Ayieko, N.S., K.K., W.O., J. Achando, B.A., E.M.W., P.O., E.B.); Perelman School of Medicine, University of Pennsylvania, Philadelphia (H.T.); and the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD (M.B.).'}, {'ForeName': 'Gabriel', 'Initials': 'G', 'LastName': 'Chamie', 'Affiliation': 'From the Division of HIV, Infectious Diseases, and Global Medicine, Department of Medicine (D.V.H., T.D.C., T.L., G.C., V.J., D.B., K.S., C.K., L.B., C.M.), the Division of Prevention Science, Department of Medicine (E.D.C., S.B.S., A.P.), the Department of Obstetrics, Gynecology, and Reproductive Sciences (C.S.C., R.B., M.G., C.R.C.), and the Division of Infectious Diseases, Department of Pediatrics (T.R.), University of California, San Francisco, and the San Francisco Department of Public Health (Y.-H.C.), San Francisco, the Division of Epidemiology and Biostatistics, the School of Public Health, University of California, Berkeley (J.S., M.L., M.P.), and Gilead Sciences, Foster City (J.F.R.) - all in California; the School of Public Health and Health Sciences, University of Massachusetts, Amherst (L.B.B.); the Infectious Diseases Research Collaboration (D.K., J. Kabami, M.A., E.S., D.M.B., F.M., A.O., H.N., J. Kironde, S.O., G.L.) and the School of Medicine, Makerere University (M.R.K.), Kampala, Uganda; Kenya Medical Research Institute, Nairobi (J. Ayieko, N.S., K.K., W.O., J. Achando, B.A., E.M.W., P.O., E.B.); Perelman School of Medicine, University of Pennsylvania, Philadelphia (H.T.); and the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD (M.B.).'}, {'ForeName': 'Carol S', 'Initials': 'CS', 'LastName': 'Camlin', 'Affiliation': 'From the Division of HIV, Infectious Diseases, and Global Medicine, Department of Medicine (D.V.H., T.D.C., T.L., G.C., V.J., D.B., K.S., C.K., L.B., C.M.), the Division of Prevention Science, Department of Medicine (E.D.C., S.B.S., A.P.), the Department of Obstetrics, Gynecology, and Reproductive Sciences (C.S.C., R.B., M.G., C.R.C.), and the Division of Infectious Diseases, Department of Pediatrics (T.R.), University of California, San Francisco, and the San Francisco Department of Public Health (Y.-H.C.), San Francisco, the Division of Epidemiology and Biostatistics, the School of Public Health, University of California, Berkeley (J.S., M.L., M.P.), and Gilead Sciences, Foster City (J.F.R.) - all in California; the School of Public Health and Health Sciences, University of Massachusetts, Amherst (L.B.B.); the Infectious Diseases Research Collaboration (D.K., J. Kabami, M.A., E.S., D.M.B., F.M., A.O., H.N., J. Kironde, S.O., G.L.) and the School of Medicine, Makerere University (M.R.K.), Kampala, Uganda; Kenya Medical Research Institute, Nairobi (J. Ayieko, N.S., K.K., W.O., J. Achando, B.A., E.M.W., P.O., E.B.); Perelman School of Medicine, University of Pennsylvania, Philadelphia (H.T.); and the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD (M.B.).'}, {'ForeName': 'Vivek', 'Initials': 'V', 'LastName': 'Jain', 'Affiliation': 'From the Division of HIV, Infectious Diseases, and Global Medicine, Department of Medicine (D.V.H., T.D.C., T.L., G.C., V.J., D.B., K.S., C.K., L.B., C.M.), the Division of Prevention Science, Department of Medicine (E.D.C., S.B.S., A.P.), the Department of Obstetrics, Gynecology, and Reproductive Sciences (C.S.C., R.B., M.G., C.R.C.), and the Division of Infectious Diseases, Department of Pediatrics (T.R.), University of California, San Francisco, and the San Francisco Department of Public Health (Y.-H.C.), San Francisco, the Division of Epidemiology and Biostatistics, the School of Public Health, University of California, Berkeley (J.S., M.L., M.P.), and Gilead Sciences, Foster City (J.F.R.) - all in California; the School of Public Health and Health Sciences, University of Massachusetts, Amherst (L.B.B.); the Infectious Diseases Research Collaboration (D.K., J. Kabami, M.A., E.S., D.M.B., F.M., A.O., H.N., J. Kironde, S.O., G.L.) and the School of Medicine, Makerere University (M.R.K.), Kampala, Uganda; Kenya Medical Research Institute, Nairobi (J. Ayieko, N.S., K.K., W.O., J. Achando, B.A., E.M.W., P.O., E.B.); Perelman School of Medicine, University of Pennsylvania, Philadelphia (H.T.); and the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD (M.B.).'}, {'ForeName': 'Kevin', 'Initials': 'K', 'LastName': 'Kadede', 'Affiliation': 'From the Division of HIV, Infectious Diseases, and Global Medicine, Department of Medicine (D.V.H., T.D.C., T.L., G.C., V.J., D.B., K.S., C.K., L.B., C.M.), the Division of Prevention Science, Department of Medicine (E.D.C., S.B.S., A.P.), the Department of Obstetrics, Gynecology, and Reproductive Sciences (C.S.C., R.B., M.G., C.R.C.), and the Division of Infectious Diseases, Department of Pediatrics (T.R.), University of California, San Francisco, and the San Francisco Department of Public Health (Y.-H.C.), San Francisco, the Division of Epidemiology and Biostatistics, the School of Public Health, University of California, Berkeley (J.S., M.L., M.P.), and Gilead Sciences, Foster City (J.F.R.) - all in California; the School of Public Health and Health Sciences, University of Massachusetts, Amherst (L.B.B.); the Infectious Diseases Research Collaboration (D.K., J. Kabami, M.A., E.S., D.M.B., F.M., A.O., H.N., J. Kironde, S.O., G.L.) and the School of Medicine, Makerere University (M.R.K.), Kampala, Uganda; Kenya Medical Research Institute, Nairobi (J. Ayieko, N.S., K.K., W.O., J. Achando, B.A., E.M.W., P.O., E.B.); Perelman School of Medicine, University of Pennsylvania, Philadelphia (H.T.); and the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD (M.B.).'}, {'ForeName': 'Mucunguzi', 'Initials': 'M', 'LastName': 'Atukunda', 'Affiliation': 'From the Division of HIV, Infectious Diseases, and Global Medicine, Department of Medicine (D.V.H., T.D.C., T.L., G.C., V.J., D.B., K.S., C.K., L.B., C.M.), the Division of Prevention Science, Department of Medicine (E.D.C., S.B.S., A.P.), the Department of Obstetrics, Gynecology, and Reproductive Sciences (C.S.C., R.B., M.G., C.R.C.), and the Division of Infectious Diseases, Department of Pediatrics (T.R.), University of California, San Francisco, and the San Francisco Department of Public Health (Y.-H.C.), San Francisco, the Division of Epidemiology and Biostatistics, the School of Public Health, University of California, Berkeley (J.S., M.L., M.P.), and Gilead Sciences, Foster City (J.F.R.) - all in California; the School of Public Health and Health Sciences, University of Massachusetts, Amherst (L.B.B.); the Infectious Diseases Research Collaboration (D.K., J. Kabami, M.A., E.S., D.M.B., F.M., A.O., H.N., J. Kironde, S.O., G.L.) and the School of Medicine, Makerere University (M.R.K.), Kampala, Uganda; Kenya Medical Research Institute, Nairobi (J. Ayieko, N.S., K.K., W.O., J. Achando, B.A., E.M.W., P.O., E.B.); Perelman School of Medicine, University of Pennsylvania, Philadelphia (H.T.); and the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD (M.B.).'}, {'ForeName': 'Theodore', 'Initials': 'T', 'LastName': 'Ruel', 'Affiliation': 'From the Division of HIV, Infectious Diseases, and Global Medicine, Department of Medicine (D.V.H., T.D.C., T.L., G.C., V.J., D.B., K.S., C.K., L.B., C.M.), the Division of Prevention Science, Department of Medicine (E.D.C., S.B.S., A.P.), the Department of Obstetrics, Gynecology, and Reproductive Sciences (C.S.C., R.B., M.G., C.R.C.), and the Division of Infectious Diseases, Department of Pediatrics (T.R.), University of California, San Francisco, and the San Francisco Department of Public Health (Y.-H.C.), San Francisco, the Division of Epidemiology and Biostatistics, the School of Public Health, University of California, Berkeley (J.S., M.L., M.P.), and Gilead Sciences, Foster City (J.F.R.) - all in California; the School of Public Health and Health Sciences, University of Massachusetts, Amherst (L.B.B.); the Infectious Diseases Research Collaboration (D.K., J. Kabami, M.A., E.S., D.M.B., F.M., A.O., H.N., J. Kironde, S.O., G.L.) and the School of Medicine, Makerere University (M.R.K.), Kampala, Uganda; Kenya Medical Research Institute, Nairobi (J. Ayieko, N.S., K.K., W.O., J. Achando, B.A., E.M.W., P.O., E.B.); Perelman School of Medicine, University of Pennsylvania, Philadelphia (H.T.); and the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD (M.B.).'}, {'ForeName': 'Starley B', 'Initials': 'SB', 'LastName': 'Shade', 'Affiliation': 'From the Division of HIV, Infectious Diseases, and Global Medicine, Department of Medicine (D.V.H., T.D.C., T.L., G.C., V.J., D.B., K.S., C.K., L.B., C.M.), the Division of Prevention Science, Department of Medicine (E.D.C., S.B.S., A.P.), the Department of Obstetrics, Gynecology, and Reproductive Sciences (C.S.C., R.B., M.G., C.R.C.), and the Division of Infectious Diseases, Department of Pediatrics (T.R.), University of California, San Francisco, and the San Francisco Department of Public Health (Y.-H.C.), San Francisco, the Division of Epidemiology and Biostatistics, the School of Public Health, University of California, Berkeley (J.S., M.L., M.P.), and Gilead Sciences, Foster City (J.F.R.) - all in California; the School of Public Health and Health Sciences, University of Massachusetts, Amherst (L.B.B.); the Infectious Diseases Research Collaboration (D.K., J. Kabami, M.A., E.S., D.M.B., F.M., A.O., H.N., J. Kironde, S.O., G.L.) and the School of Medicine, Makerere University (M.R.K.), Kampala, Uganda; Kenya Medical Research Institute, Nairobi (J. Ayieko, N.S., K.K., W.O., J. Achando, B.A., E.M.W., P.O., E.B.); Perelman School of Medicine, University of Pennsylvania, Philadelphia (H.T.); and the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD (M.B.).'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Ssemmondo', 'Affiliation': 'From the Division of HIV, Infectious Diseases, and Global Medicine, Department of Medicine (D.V.H., T.D.C., T.L., G.C., V.J., D.B., K.S., C.K., L.B., C.M.), the Division of Prevention Science, Department of Medicine (E.D.C., S.B.S., A.P.), the Department of Obstetrics, Gynecology, and Reproductive Sciences (C.S.C., R.B., M.G., C.R.C.), and the Division of Infectious Diseases, Department of Pediatrics (T.R.), University of California, San Francisco, and the San Francisco Department of Public Health (Y.-H.C.), San Francisco, the Division of Epidemiology and Biostatistics, the School of Public Health, University of California, Berkeley (J.S., M.L., M.P.), and Gilead Sciences, Foster City (J.F.R.) - all in California; the School of Public Health and Health Sciences, University of Massachusetts, Amherst (L.B.B.); the Infectious Diseases Research Collaboration (D.K., J. Kabami, M.A., E.S., D.M.B., F.M., A.O., H.N., J. Kironde, S.O., G.L.) and the School of Medicine, Makerere University (M.R.K.), Kampala, Uganda; Kenya Medical Research Institute, Nairobi (J. Ayieko, N.S., K.K., W.O., J. Achando, B.A., E.M.W., P.O., E.B.); Perelman School of Medicine, University of Pennsylvania, Philadelphia (H.T.); and the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD (M.B.).'}, {'ForeName': 'Dathan M', 'Initials': 'DM', 'LastName': 'Byonanebye', 'Affiliation': 'From the Division of HIV, Infectious Diseases, and Global Medicine, Department of Medicine (D.V.H., T.D.C., T.L., G.C., V.J., D.B., K.S., C.K., L.B., C.M.), the Division of Prevention Science, Department of Medicine (E.D.C., S.B.S., A.P.), the Department of Obstetrics, Gynecology, and Reproductive Sciences (C.S.C., R.B., M.G., C.R.C.), and the Division of Infectious Diseases, Department of Pediatrics (T.R.), University of California, San Francisco, and the San Francisco Department of Public Health (Y.-H.C.), San Francisco, the Division of Epidemiology and Biostatistics, the School of Public Health, University of California, Berkeley (J.S., M.L., M.P.), and Gilead Sciences, Foster City (J.F.R.) - all in California; the School of Public Health and Health Sciences, University of Massachusetts, Amherst (L.B.B.); the Infectious Diseases Research Collaboration (D.K., J. Kabami, M.A., E.S., D.M.B., F.M., A.O., H.N., J. Kironde, S.O., G.L.) and the School of Medicine, Makerere University (M.R.K.), Kampala, Uganda; Kenya Medical Research Institute, Nairobi (J. Ayieko, N.S., K.K., W.O., J. Achando, B.A., E.M.W., P.O., E.B.); Perelman School of Medicine, University of Pennsylvania, Philadelphia (H.T.); and the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD (M.B.).'}, {'ForeName': 'Florence', 'Initials': 'F', 'LastName': 'Mwangwa', 'Affiliation': 'From the Division of HIV, Infectious Diseases, and Global Medicine, Department of Medicine (D.V.H., T.D.C., T.L., G.C., V.J., D.B., K.S., C.K., L.B., C.M.), the Division of Prevention Science, Department of Medicine (E.D.C., S.B.S., A.P.), the Department of Obstetrics, Gynecology, and Reproductive Sciences (C.S.C., R.B., M.G., C.R.C.), and the Division of Infectious Diseases, Department of Pediatrics (T.R.), University of California, San Francisco, and the San Francisco Department of Public Health (Y.-H.C.), San Francisco, the Division of Epidemiology and Biostatistics, the School of Public Health, University of California, Berkeley (J.S., M.L., M.P.), and Gilead Sciences, Foster City (J.F.R.) - all in California; the School of Public Health and Health Sciences, University of Massachusetts, Amherst (L.B.B.); the Infectious Diseases Research Collaboration (D.K., J. Kabami, M.A., E.S., D.M.B., F.M., A.O., H.N., J. Kironde, S.O., G.L.) and the School of Medicine, Makerere University (M.R.K.), Kampala, Uganda; Kenya Medical Research Institute, Nairobi (J. Ayieko, N.S., K.K., W.O., J. Achando, B.A., E.M.W., P.O., E.B.); Perelman School of Medicine, University of Pennsylvania, Philadelphia (H.T.); and the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD (M.B.).'}, {'ForeName': 'Asiphas', 'Initials': 'A', 'LastName': 'Owaraganise', 'Affiliation': 'From the Division of HIV, Infectious Diseases, and Global Medicine, Department of Medicine (D.V.H., T.D.C., T.L., G.C., V.J., D.B., K.S., C.K., L.B., C.M.), the Division of Prevention Science, Department of Medicine (E.D.C., S.B.S., A.P.), the Department of Obstetrics, Gynecology, and Reproductive Sciences (C.S.C., R.B., M.G., C.R.C.), and the Division of Infectious Diseases, Department of Pediatrics (T.R.), University of California, San Francisco, and the San Francisco Department of Public Health (Y.-H.C.), San Francisco, the Division of Epidemiology and Biostatistics, the School of Public Health, University of California, Berkeley (J.S., M.L., M.P.), and Gilead Sciences, Foster City (J.F.R.) - all in California; the School of Public Health and Health Sciences, University of Massachusetts, Amherst (L.B.B.); the Infectious Diseases Research Collaboration (D.K., J. Kabami, M.A., E.S., D.M.B., F.M., A.O., H.N., J. Kironde, S.O., G.L.) and the School of Medicine, Makerere University (M.R.K.), Kampala, Uganda; Kenya Medical Research Institute, Nairobi (J. Ayieko, N.S., K.K., W.O., J. Achando, B.A., E.M.W., P.O., E.B.); Perelman School of Medicine, University of Pennsylvania, Philadelphia (H.T.); and the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD (M.B.).'}, {'ForeName': 'Winter', 'Initials': 'W', 'LastName': 'Olilo', 'Affiliation': 'From the Division of HIV, Infectious Diseases, and Global Medicine, Department of Medicine (D.V.H., T.D.C., T.L., G.C., V.J., D.B., K.S., C.K., L.B., C.M.), the Division of Prevention Science, Department of Medicine (E.D.C., S.B.S., A.P.), the Department of Obstetrics, Gynecology, and Reproductive Sciences (C.S.C., R.B., M.G., C.R.C.), and the Division of Infectious Diseases, Department of Pediatrics (T.R.), University of California, San Francisco, and the San Francisco Department of Public Health (Y.-H.C.), San Francisco, the Division of Epidemiology and Biostatistics, the School of Public Health, University of California, Berkeley (J.S., M.L., M.P.), and Gilead Sciences, Foster City (J.F.R.) - all in California; the School of Public Health and Health Sciences, University of Massachusetts, Amherst (L.B.B.); the Infectious Diseases Research Collaboration (D.K., J. Kabami, M.A., E.S., D.M.B., F.M., A.O., H.N., J. Kironde, S.O., G.L.) and the School of Medicine, Makerere University (M.R.K.), Kampala, Uganda; Kenya Medical Research Institute, Nairobi (J. Ayieko, N.S., K.K., W.O., J. Achando, B.A., E.M.W., P.O., E.B.); Perelman School of Medicine, University of Pennsylvania, Philadelphia (H.T.); and the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD (M.B.).'}, {'ForeName': 'Douglas', 'Initials': 'D', 'LastName': 'Black', 'Affiliation': 'From the Division of HIV, Infectious Diseases, and Global Medicine, Department of Medicine (D.V.H., T.D.C., T.L., G.C., V.J., D.B., K.S., C.K., L.B., C.M.), the Division of Prevention Science, Department of Medicine (E.D.C., S.B.S., A.P.), the Department of Obstetrics, Gynecology, and Reproductive Sciences (C.S.C., R.B., M.G., C.R.C.), and the Division of Infectious Diseases, Department of Pediatrics (T.R.), University of California, San Francisco, and the San Francisco Department of Public Health (Y.-H.C.), San Francisco, the Division of Epidemiology and Biostatistics, the School of Public Health, University of California, Berkeley (J.S., M.L., M.P.), and Gilead Sciences, Foster City (J.F.R.) - all in California; the School of Public Health and Health Sciences, University of Massachusetts, Amherst (L.B.B.); the Infectious Diseases Research Collaboration (D.K., J. Kabami, M.A., E.S., D.M.B., F.M., A.O., H.N., J. Kironde, S.O., G.L.) and the School of Medicine, Makerere University (M.R.K.), Kampala, Uganda; Kenya Medical Research Institute, Nairobi (J. Ayieko, N.S., K.K., W.O., J. Achando, B.A., E.M.W., P.O., E.B.); Perelman School of Medicine, University of Pennsylvania, Philadelphia (H.T.); and the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD (M.B.).'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Snyman', 'Affiliation': 'From the Division of HIV, Infectious Diseases, and Global Medicine, Department of Medicine (D.V.H., T.D.C., T.L., G.C., V.J., D.B., K.S., C.K., L.B., C.M.), the Division of Prevention Science, Department of Medicine (E.D.C., S.B.S., A.P.), the Department of Obstetrics, Gynecology, and Reproductive Sciences (C.S.C., R.B., M.G., C.R.C.), and the Division of Infectious Diseases, Department of Pediatrics (T.R.), University of California, San Francisco, and the San Francisco Department of Public Health (Y.-H.C.), San Francisco, the Division of Epidemiology and Biostatistics, the School of Public Health, University of California, Berkeley (J.S., M.L., M.P.), and Gilead Sciences, Foster City (J.F.R.) - all in California; the School of Public Health and Health Sciences, University of Massachusetts, Amherst (L.B.B.); the Infectious Diseases Research Collaboration (D.K., J. Kabami, M.A., E.S., D.M.B., F.M., A.O., H.N., J. Kironde, S.O., G.L.) and the School of Medicine, Makerere University (M.R.K.), Kampala, Uganda; Kenya Medical Research Institute, Nairobi (J. Ayieko, N.S., K.K., W.O., J. Achando, B.A., E.M.W., P.O., E.B.); Perelman School of Medicine, University of Pennsylvania, Philadelphia (H.T.); and the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD (M.B.).'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Burger', 'Affiliation': 'From the Division of HIV, Infectious Diseases, and Global Medicine, Department of Medicine (D.V.H., T.D.C., T.L., G.C., V.J., D.B., K.S., C.K., L.B., C.M.), the Division of Prevention Science, Department of Medicine (E.D.C., S.B.S., A.P.), the Department of Obstetrics, Gynecology, and Reproductive Sciences (C.S.C., R.B., M.G., C.R.C.), and the Division of Infectious Diseases, Department of Pediatrics (T.R.), University of California, San Francisco, and the San Francisco Department of Public Health (Y.-H.C.), San Francisco, the Division of Epidemiology and Biostatistics, the School of Public Health, University of California, Berkeley (J.S., M.L., M.P.), and Gilead Sciences, Foster City (J.F.R.) - all in California; the School of Public Health and Health Sciences, University of Massachusetts, Amherst (L.B.B.); the Infectious Diseases Research Collaboration (D.K., J. Kabami, M.A., E.S., D.M.B., F.M., A.O., H.N., J. Kironde, S.O., G.L.) and the School of Medicine, Makerere University (M.R.K.), Kampala, Uganda; Kenya Medical Research Institute, Nairobi (J. Ayieko, N.S., K.K., W.O., J. Achando, B.A., E.M.W., P.O., E.B.); Perelman School of Medicine, University of Pennsylvania, Philadelphia (H.T.); and the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD (M.B.).'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Getahun', 'Affiliation': 'From the Division of HIV, Infectious Diseases, and Global Medicine, Department of Medicine (D.V.H., T.D.C., T.L., G.C., V.J., D.B., K.S., C.K., L.B., C.M.), the Division of Prevention Science, Department of Medicine (E.D.C., S.B.S., A.P.), the Department of Obstetrics, Gynecology, and Reproductive Sciences (C.S.C., R.B., M.G., C.R.C.), and the Division of Infectious Diseases, Department of Pediatrics (T.R.), University of California, San Francisco, and the San Francisco Department of Public Health (Y.-H.C.), San Francisco, the Division of Epidemiology and Biostatistics, the School of Public Health, University of California, Berkeley (J.S., M.L., M.P.), and Gilead Sciences, Foster City (J.F.R.) - all in California; the School of Public Health and Health Sciences, University of Massachusetts, Amherst (L.B.B.); the Infectious Diseases Research Collaboration (D.K., J. Kabami, M.A., E.S., D.M.B., F.M., A.O., H.N., J. Kironde, S.O., G.L.) and the School of Medicine, Makerere University (M.R.K.), Kampala, Uganda; Kenya Medical Research Institute, Nairobi (J. Ayieko, N.S., K.K., W.O., J. Achando, B.A., E.M.W., P.O., E.B.); Perelman School of Medicine, University of Pennsylvania, Philadelphia (H.T.); and the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD (M.B.).'}, {'ForeName': 'Jackson', 'Initials': 'J', 'LastName': 'Achando', 'Affiliation': 'From the Division of HIV, Infectious Diseases, and Global Medicine, Department of Medicine (D.V.H., T.D.C., T.L., G.C., V.J., D.B., K.S., C.K., L.B., C.M.), the Division of Prevention Science, Department of Medicine (E.D.C., S.B.S., A.P.), the Department of Obstetrics, Gynecology, and Reproductive Sciences (C.S.C., R.B., M.G., C.R.C.), and the Division of Infectious Diseases, Department of Pediatrics (T.R.), University of California, San Francisco, and the San Francisco Department of Public Health (Y.-H.C.), San Francisco, the Division of Epidemiology and Biostatistics, the School of Public Health, University of California, Berkeley (J.S., M.L., M.P.), and Gilead Sciences, Foster City (J.F.R.) - all in California; the School of Public Health and Health Sciences, University of Massachusetts, Amherst (L.B.B.); the Infectious Diseases Research Collaboration (D.K., J. Kabami, M.A., E.S., D.M.B., F.M., A.O., H.N., J. Kironde, S.O., G.L.) and the School of Medicine, Makerere University (M.R.K.), Kampala, Uganda; Kenya Medical Research Institute, Nairobi (J. Ayieko, N.S., K.K., W.O., J. Achando, B.A., E.M.W., P.O., E.B.); Perelman School of Medicine, University of Pennsylvania, Philadelphia (H.T.); and the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD (M.B.).'}, {'ForeName': 'Benard', 'Initials': 'B', 'LastName': 'Awuonda', 'Affiliation': 'From the Division of HIV, Infectious Diseases, and Global Medicine, Department of Medicine (D.V.H., T.D.C., T.L., G.C., V.J., D.B., K.S., C.K., L.B., C.M.), the Division of Prevention Science, Department of Medicine (E.D.C., S.B.S., A.P.), the Department of Obstetrics, Gynecology, and Reproductive Sciences (C.S.C., R.B., M.G., C.R.C.), and the Division of Infectious Diseases, Department of Pediatrics (T.R.), University of California, San Francisco, and the San Francisco Department of Public Health (Y.-H.C.), San Francisco, the Division of Epidemiology and Biostatistics, the School of Public Health, University of California, Berkeley (J.S., M.L., M.P.), and Gilead Sciences, Foster City (J.F.R.) - all in California; the School of Public Health and Health Sciences, University of Massachusetts, Amherst (L.B.B.); the Infectious Diseases Research Collaboration (D.K., J. Kabami, M.A., E.S., D.M.B., F.M., A.O., H.N., J. Kironde, S.O., G.L.) and the School of Medicine, Makerere University (M.R.K.), Kampala, Uganda; Kenya Medical Research Institute, Nairobi (J. Ayieko, N.S., K.K., W.O., J. Achando, B.A., E.M.W., P.O., E.B.); Perelman School of Medicine, University of Pennsylvania, Philadelphia (H.T.); and the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD (M.B.).'}, {'ForeName': 'Hellen', 'Initials': 'H', 'LastName': 'Nakato', 'Affiliation': 'From the Division of HIV, Infectious Diseases, and Global Medicine, Department of Medicine (D.V.H., T.D.C., T.L., G.C., V.J., D.B., K.S., C.K., L.B., C.M.), the Division of Prevention Science, Department of Medicine (E.D.C., S.B.S., A.P.), the Department of Obstetrics, Gynecology, and Reproductive Sciences (C.S.C., R.B., M.G., C.R.C.), and the Division of Infectious Diseases, Department of Pediatrics (T.R.), University of California, San Francisco, and the San Francisco Department of Public Health (Y.-H.C.), San Francisco, the Division of Epidemiology and Biostatistics, the School of Public Health, University of California, Berkeley (J.S., M.L., M.P.), and Gilead Sciences, Foster City (J.F.R.) - all in California; the School of Public Health and Health Sciences, University of Massachusetts, Amherst (L.B.B.); the Infectious Diseases Research Collaboration (D.K., J. Kabami, M.A., E.S., D.M.B., F.M., A.O., H.N., J. Kironde, S.O., G.L.) and the School of Medicine, Makerere University (M.R.K.), Kampala, Uganda; Kenya Medical Research Institute, Nairobi (J. Ayieko, N.S., K.K., W.O., J. Achando, B.A., E.M.W., P.O., E.B.); Perelman School of Medicine, University of Pennsylvania, Philadelphia (H.T.); and the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD (M.B.).'}, {'ForeName': 'Joel', 'Initials': 'J', 'LastName': 'Kironde', 'Affiliation': 'From the Division of HIV, Infectious Diseases, and Global Medicine, Department of Medicine (D.V.H., T.D.C., T.L., G.C., V.J., D.B., K.S., C.K., L.B., C.M.), the Division of Prevention Science, Department of Medicine (E.D.C., S.B.S., A.P.), the Department of Obstetrics, Gynecology, and Reproductive Sciences (C.S.C., R.B., M.G., C.R.C.), and the Division of Infectious Diseases, Department of Pediatrics (T.R.), University of California, San Francisco, and the San Francisco Department of Public Health (Y.-H.C.), San Francisco, the Division of Epidemiology and Biostatistics, the School of Public Health, University of California, Berkeley (J.S., M.L., M.P.), and Gilead Sciences, Foster City (J.F.R.) - all in California; the School of Public Health and Health Sciences, University of Massachusetts, Amherst (L.B.B.); the Infectious Diseases Research Collaboration (D.K., J. Kabami, M.A., E.S., D.M.B., F.M., A.O., H.N., J. Kironde, S.O., G.L.) and the School of Medicine, Makerere University (M.R.K.), Kampala, Uganda; Kenya Medical Research Institute, Nairobi (J. Ayieko, N.S., K.K., W.O., J. Achando, B.A., E.M.W., P.O., E.B.); Perelman School of Medicine, University of Pennsylvania, Philadelphia (H.T.); and the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD (M.B.).'}, {'ForeName': 'Samuel', 'Initials': 'S', 'LastName': 'Okiror', 'Affiliation': 'From the Division of HIV, Infectious Diseases, and Global Medicine, Department of Medicine (D.V.H., T.D.C., T.L., G.C., V.J., D.B., K.S., C.K., L.B., C.M.), the Division of Prevention Science, Department of Medicine (E.D.C., S.B.S., A.P.), the Department of Obstetrics, Gynecology, and Reproductive Sciences (C.S.C., R.B., M.G., C.R.C.), and the Division of Infectious Diseases, Department of Pediatrics (T.R.), University of California, San Francisco, and the San Francisco Department of Public Health (Y.-H.C.), San Francisco, the Division of Epidemiology and Biostatistics, the School of Public Health, University of California, Berkeley (J.S., M.L., M.P.), and Gilead Sciences, Foster City (J.F.R.) - all in California; the School of Public Health and Health Sciences, University of Massachusetts, Amherst (L.B.B.); the Infectious Diseases Research Collaboration (D.K., J. Kabami, M.A., E.S., D.M.B., F.M., A.O., H.N., J. Kironde, S.O., G.L.) and the School of Medicine, Makerere University (M.R.K.), Kampala, Uganda; Kenya Medical Research Institute, Nairobi (J. Ayieko, N.S., K.K., W.O., J. Achando, B.A., E.M.W., P.O., E.B.); Perelman School of Medicine, University of Pennsylvania, Philadelphia (H.T.); and the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD (M.B.).'}, {'ForeName': 'Harsha', 'Initials': 'H', 'LastName': 'Thirumurthy', 'Affiliation': 'From the Division of HIV, Infectious Diseases, and Global Medicine, Department of Medicine (D.V.H., T.D.C., T.L., G.C., V.J., D.B., K.S., C.K., L.B., C.M.), the Division of Prevention Science, Department of Medicine (E.D.C., S.B.S., A.P.), the Department of Obstetrics, Gynecology, and Reproductive Sciences (C.S.C., R.B., M.G., C.R.C.), and the Division of Infectious Diseases, Department of Pediatrics (T.R.), University of California, San Francisco, and the San Francisco Department of Public Health (Y.-H.C.), San Francisco, the Division of Epidemiology and Biostatistics, the School of Public Health, University of California, Berkeley (J.S., M.L., M.P.), and Gilead Sciences, Foster City (J.F.R.) - all in California; the School of Public Health and Health Sciences, University of Massachusetts, Amherst (L.B.B.); the Infectious Diseases Research Collaboration (D.K., J. Kabami, M.A., E.S., D.M.B., F.M., A.O., H.N., J. Kironde, S.O., G.L.) and the School of Medicine, Makerere University (M.R.K.), Kampala, Uganda; Kenya Medical Research Institute, Nairobi (J. Ayieko, N.S., K.K., W.O., J. Achando, B.A., E.M.W., P.O., E.B.); Perelman School of Medicine, University of Pennsylvania, Philadelphia (H.T.); and the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD (M.B.).'}, {'ForeName': 'Catherine', 'Initials': 'C', 'LastName': 'Koss', 'Affiliation': 'From the Division of HIV, Infectious Diseases, and Global Medicine, Department of Medicine (D.V.H., T.D.C., T.L., G.C., V.J., D.B., K.S., C.K., L.B., C.M.), the Division of Prevention Science, Department of Medicine (E.D.C., S.B.S., A.P.), the Department of Obstetrics, Gynecology, and Reproductive Sciences (C.S.C., R.B., M.G., C.R.C.), and the Division of Infectious Diseases, Department of Pediatrics (T.R.), University of California, San Francisco, and the San Francisco Department of Public Health (Y.-H.C.), San Francisco, the Division of Epidemiology and Biostatistics, the School of Public Health, University of California, Berkeley (J.S., M.L., M.P.), and Gilead Sciences, Foster City (J.F.R.) - all in California; the School of Public Health and Health Sciences, University of Massachusetts, Amherst (L.B.B.); the Infectious Diseases Research Collaboration (D.K., J. Kabami, M.A., E.S., D.M.B., F.M., A.O., H.N., J. Kironde, S.O., G.L.) and the School of Medicine, Makerere University (M.R.K.), Kampala, Uganda; Kenya Medical Research Institute, Nairobi (J. Ayieko, N.S., K.K., W.O., J. Achando, B.A., E.M.W., P.O., E.B.); Perelman School of Medicine, University of Pennsylvania, Philadelphia (H.T.); and the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD (M.B.).'}, {'ForeName': 'Lillian', 'Initials': 'L', 'LastName': 'Brown', 'Affiliation': 'From the Division of HIV, Infectious Diseases, and Global Medicine, Department of Medicine (D.V.H., T.D.C., T.L., G.C., V.J., D.B., K.S., C.K., L.B., C.M.), the Division of Prevention Science, Department of Medicine (E.D.C., S.B.S., A.P.), the Department of Obstetrics, Gynecology, and Reproductive Sciences (C.S.C., R.B., M.G., C.R.C.), and the Division of Infectious Diseases, Department of Pediatrics (T.R.), University of California, San Francisco, and the San Francisco Department of Public Health (Y.-H.C.), San Francisco, the Division of Epidemiology and Biostatistics, the School of Public Health, University of California, Berkeley (J.S., M.L., M.P.), and Gilead Sciences, Foster City (J.F.R.) - all in California; the School of Public Health and Health Sciences, University of Massachusetts, Amherst (L.B.B.); the Infectious Diseases Research Collaboration (D.K., J. Kabami, M.A., E.S., D.M.B., F.M., A.O., H.N., J. Kironde, S.O., G.L.) and the School of Medicine, Makerere University (M.R.K.), Kampala, Uganda; Kenya Medical Research Institute, Nairobi (J. Ayieko, N.S., K.K., W.O., J. Achando, B.A., E.M.W., P.O., E.B.); Perelman School of Medicine, University of Pennsylvania, Philadelphia (H.T.); and the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD (M.B.).'}, {'ForeName': 'Carina', 'Initials': 'C', 'LastName': 'Marquez', 'Affiliation': 'From the Division of HIV, Infectious Diseases, and Global Medicine, Department of Medicine (D.V.H., T.D.C., T.L., G.C., V.J., D.B., K.S., C.K., L.B., C.M.), the Division of Prevention Science, Department of Medicine (E.D.C., S.B.S., A.P.), the Department of Obstetrics, Gynecology, and Reproductive Sciences (C.S.C., R.B., M.G., C.R.C.), and the Division of Infectious Diseases, Department of Pediatrics (T.R.), University of California, San Francisco, and the San Francisco Department of Public Health (Y.-H.C.), San Francisco, the Division of Epidemiology and Biostatistics, the School of Public Health, University of California, Berkeley (J.S., M.L., M.P.), and Gilead Sciences, Foster City (J.F.R.) - all in California; the School of Public Health and Health Sciences, University of Massachusetts, Amherst (L.B.B.); the Infectious Diseases Research Collaboration (D.K., J. Kabami, M.A., E.S., D.M.B., F.M., A.O., H.N., J. Kironde, S.O., G.L.) and the School of Medicine, Makerere University (M.R.K.), Kampala, Uganda; Kenya Medical Research Institute, Nairobi (J. Ayieko, N.S., K.K., W.O., J. Achando, B.A., E.M.W., P.O., E.B.); Perelman School of Medicine, University of Pennsylvania, Philadelphia (H.T.); and the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD (M.B.).'}, {'ForeName': 'Joshua', 'Initials': 'J', 'LastName': 'Schwab', 'Affiliation': 'From the Division of HIV, Infectious Diseases, and Global Medicine, Department of Medicine (D.V.H., T.D.C., T.L., G.C., V.J., D.B., K.S., C.K., L.B., C.M.), the Division of Prevention Science, Department of Medicine (E.D.C., S.B.S., A.P.), the Department of Obstetrics, Gynecology, and Reproductive Sciences (C.S.C., R.B., M.G., C.R.C.), and the Division of Infectious Diseases, Department of Pediatrics (T.R.), University of California, San Francisco, and the San Francisco Department of Public Health (Y.-H.C.), San Francisco, the Division of Epidemiology and Biostatistics, the School of Public Health, University of California, Berkeley (J.S., M.L., M.P.), and Gilead Sciences, Foster City (J.F.R.) - all in California; the School of Public Health and Health Sciences, University of Massachusetts, Amherst (L.B.B.); the Infectious Diseases Research Collaboration (D.K., J. Kabami, M.A., E.S., D.M.B., F.M., A.O., H.N., J. Kironde, S.O., G.L.) and the School of Medicine, Makerere University (M.R.K.), Kampala, Uganda; Kenya Medical Research Institute, Nairobi (J. Ayieko, N.S., K.K., W.O., J. Achando, B.A., E.M.W., P.O., E.B.); Perelman School of Medicine, University of Pennsylvania, Philadelphia (H.T.); and the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD (M.B.).'}, {'ForeName': 'Geoff', 'Initials': 'G', 'LastName': 'Lavoy', 'Affiliation': 'From the Division of HIV, Infectious Diseases, and Global Medicine, Department of Medicine (D.V.H., T.D.C., T.L., G.C., V.J., D.B., K.S., C.K., L.B., C.M.), the Division of Prevention Science, Department of Medicine (E.D.C., S.B.S., A.P.), the Department of Obstetrics, Gynecology, and Reproductive Sciences (C.S.C., R.B., M.G., C.R.C.), and the Division of Infectious Diseases, Department of Pediatrics (T.R.), University of California, San Francisco, and the San Francisco Department of Public Health (Y.-H.C.), San Francisco, the Division of Epidemiology and Biostatistics, the School of Public Health, University of California, Berkeley (J.S., M.L., M.P.), and Gilead Sciences, Foster City (J.F.R.) - all in California; the School of Public Health and Health Sciences, University of Massachusetts, Amherst (L.B.B.); the Infectious Diseases Research Collaboration (D.K., J. Kabami, M.A., E.S., D.M.B., F.M., A.O., H.N., J. Kironde, S.O., G.L.) and the School of Medicine, Makerere University (M.R.K.), Kampala, Uganda; Kenya Medical Research Institute, Nairobi (J. Ayieko, N.S., K.K., W.O., J. Achando, B.A., E.M.W., P.O., E.B.); Perelman School of Medicine, University of Pennsylvania, Philadelphia (H.T.); and the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD (M.B.).'}, {'ForeName': 'Albert', 'Initials': 'A', 'LastName': 'Plenty', 'Affiliation': 'From the Division of HIV, Infectious Diseases, and Global Medicine, Department of Medicine (D.V.H., T.D.C., T.L., G.C., V.J., D.B., K.S., C.K., L.B., C.M.), the Division of Prevention Science, Department of Medicine (E.D.C., S.B.S., A.P.), the Department of Obstetrics, Gynecology, and Reproductive Sciences (C.S.C., R.B., M.G., C.R.C.), and the Division of Infectious Diseases, Department of Pediatrics (T.R.), University of California, San Francisco, and the San Francisco Department of Public Health (Y.-H.C.), San Francisco, the Division of Epidemiology and Biostatistics, the School of Public Health, University of California, Berkeley (J.S., M.L., M.P.), and Gilead Sciences, Foster City (J.F.R.) - all in California; the School of Public Health and Health Sciences, University of Massachusetts, Amherst (L.B.B.); the Infectious Diseases Research Collaboration (D.K., J. Kabami, M.A., E.S., D.M.B., F.M., A.O., H.N., J. Kironde, S.O., G.L.) and the School of Medicine, Makerere University (M.R.K.), Kampala, Uganda; Kenya Medical Research Institute, Nairobi (J. Ayieko, N.S., K.K., W.O., J. Achando, B.A., E.M.W., P.O., E.B.); Perelman School of Medicine, University of Pennsylvania, Philadelphia (H.T.); and the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD (M.B.).'}, {'ForeName': 'Erick', 'Initials': 'E', 'LastName': 'Mugoma Wafula', 'Affiliation': 'From the Division of HIV, Infectious Diseases, and Global Medicine, Department of Medicine (D.V.H., T.D.C., T.L., G.C., V.J., D.B., K.S., C.K., L.B., C.M.), the Division of Prevention Science, Department of Medicine (E.D.C., S.B.S., A.P.), the Department of Obstetrics, Gynecology, and Reproductive Sciences (C.S.C., R.B., M.G., C.R.C.), and the Division of Infectious Diseases, Department of Pediatrics (T.R.), University of California, San Francisco, and the San Francisco Department of Public Health (Y.-H.C.), San Francisco, the Division of Epidemiology and Biostatistics, the School of Public Health, University of California, Berkeley (J.S., M.L., M.P.), and Gilead Sciences, Foster City (J.F.R.) - all in California; the School of Public Health and Health Sciences, University of Massachusetts, Amherst (L.B.B.); the Infectious Diseases Research Collaboration (D.K., J. Kabami, M.A., E.S., D.M.B., F.M., A.O., H.N., J. Kironde, S.O., G.L.) and the School of Medicine, Makerere University (M.R.K.), Kampala, Uganda; Kenya Medical Research Institute, Nairobi (J. Ayieko, N.S., K.K., W.O., J. Achando, B.A., E.M.W., P.O., E.B.); Perelman School of Medicine, University of Pennsylvania, Philadelphia (H.T.); and the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD (M.B.).'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Omanya', 'Affiliation': 'From the Division of HIV, Infectious Diseases, and Global Medicine, Department of Medicine (D.V.H., T.D.C., T.L., G.C., V.J., D.B., K.S., C.K., L.B., C.M.), the Division of Prevention Science, Department of Medicine (E.D.C., S.B.S., A.P.), the Department of Obstetrics, Gynecology, and Reproductive Sciences (C.S.C., R.B., M.G., C.R.C.), and the Division of Infectious Diseases, Department of Pediatrics (T.R.), University of California, San Francisco, and the San Francisco Department of Public Health (Y.-H.C.), San Francisco, the Division of Epidemiology and Biostatistics, the School of Public Health, University of California, Berkeley (J.S., M.L., M.P.), and Gilead Sciences, Foster City (J.F.R.) - all in California; the School of Public Health and Health Sciences, University of Massachusetts, Amherst (L.B.B.); the Infectious Diseases Research Collaboration (D.K., J. Kabami, M.A., E.S., D.M.B., F.M., A.O., H.N., J. Kironde, S.O., G.L.) and the School of Medicine, Makerere University (M.R.K.), Kampala, Uganda; Kenya Medical Research Institute, Nairobi (J. Ayieko, N.S., K.K., W.O., J. Achando, B.A., E.M.W., P.O., E.B.); Perelman School of Medicine, University of Pennsylvania, Philadelphia (H.T.); and the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD (M.B.).'}, {'ForeName': 'Yea-Hung', 'Initials': 'YH', 'LastName': 'Chen', 'Affiliation': 'From the Division of HIV, Infectious Diseases, and Global Medicine, Department of Medicine (D.V.H., T.D.C., T.L., G.C., V.J., D.B., K.S., C.K., L.B., C.M.), the Division of Prevention Science, Department of Medicine (E.D.C., S.B.S., A.P.), the Department of Obstetrics, Gynecology, and Reproductive Sciences (C.S.C., R.B., M.G., C.R.C.), and the Division of Infectious Diseases, Department of Pediatrics (T.R.), University of California, San Francisco, and the San Francisco Department of Public Health (Y.-H.C.), San Francisco, the Division of Epidemiology and Biostatistics, the School of Public Health, University of California, Berkeley (J.S., M.L., M.P.), and Gilead Sciences, Foster City (J.F.R.) - all in California; the School of Public Health and Health Sciences, University of Massachusetts, Amherst (L.B.B.); the Infectious Diseases Research Collaboration (D.K., J. Kabami, M.A., E.S., D.M.B., F.M., A.O., H.N., J. Kironde, S.O., G.L.) and the School of Medicine, Makerere University (M.R.K.), Kampala, Uganda; Kenya Medical Research Institute, Nairobi (J. Ayieko, N.S., K.K., W.O., J. Achando, B.A., E.M.W., P.O., E.B.); Perelman School of Medicine, University of Pennsylvania, Philadelphia (H.T.); and the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD (M.B.).'}, {'ForeName': 'James F', 'Initials': 'JF', 'LastName': 'Rooney', 'Affiliation': 'From the Division of HIV, Infectious Diseases, and Global Medicine, Department of Medicine (D.V.H., T.D.C., T.L., G.C., V.J., D.B., K.S., C.K., L.B., C.M.), the Division of Prevention Science, Department of Medicine (E.D.C., S.B.S., A.P.), the Department of Obstetrics, Gynecology, and Reproductive Sciences (C.S.C., R.B., M.G., C.R.C.), and the Division of Infectious Diseases, Department of Pediatrics (T.R.), University of California, San Francisco, and the San Francisco Department of Public Health (Y.-H.C.), San Francisco, the Division of Epidemiology and Biostatistics, the School of Public Health, University of California, Berkeley (J.S., M.L., M.P.), and Gilead Sciences, Foster City (J.F.R.) - all in California; the School of Public Health and Health Sciences, University of Massachusetts, Amherst (L.B.B.); the Infectious Diseases Research Collaboration (D.K., J. Kabami, M.A., E.S., D.M.B., F.M., A.O., H.N., J. Kironde, S.O., G.L.) and the School of Medicine, Makerere University (M.R.K.), Kampala, Uganda; Kenya Medical Research Institute, Nairobi (J. Ayieko, N.S., K.K., W.O., J. Achando, B.A., E.M.W., P.O., E.B.); Perelman School of Medicine, University of Pennsylvania, Philadelphia (H.T.); and the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD (M.B.).'}, {'ForeName': 'Melanie', 'Initials': 'M', 'LastName': 'Bacon', 'Affiliation': 'From the Division of HIV, Infectious Diseases, and Global Medicine, Department of Medicine (D.V.H., T.D.C., T.L., G.C., V.J., D.B., K.S., C.K., L.B., C.M.), the Division of Prevention Science, Department of Medicine (E.D.C., S.B.S., A.P.), the Department of Obstetrics, Gynecology, and Reproductive Sciences (C.S.C., R.B., M.G., C.R.C.), and the Division of Infectious Diseases, Department of Pediatrics (T.R.), University of California, San Francisco, and the San Francisco Department of Public Health (Y.-H.C.), San Francisco, the Division of Epidemiology and Biostatistics, the School of Public Health, University of California, Berkeley (J.S., M.L., M.P.), and Gilead Sciences, Foster City (J.F.R.) - all in California; the School of Public Health and Health Sciences, University of Massachusetts, Amherst (L.B.B.); the Infectious Diseases Research Collaboration (D.K., J. Kabami, M.A., E.S., D.M.B., F.M., A.O., H.N., J. Kironde, S.O., G.L.) and the School of Medicine, Makerere University (M.R.K.), Kampala, Uganda; Kenya Medical Research Institute, Nairobi (J. Ayieko, N.S., K.K., W.O., J. Achando, B.A., E.M.W., P.O., E.B.); Perelman School of Medicine, University of Pennsylvania, Philadelphia (H.T.); and the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD (M.B.).'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'van der Laan', 'Affiliation': 'From the Division of HIV, Infectious Diseases, and Global Medicine, Department of Medicine (D.V.H., T.D.C., T.L., G.C., V.J., D.B., K.S., C.K., L.B., C.M.), the Division of Prevention Science, Department of Medicine (E.D.C., S.B.S., A.P.), the Department of Obstetrics, Gynecology, and Reproductive Sciences (C.S.C., R.B., M.G., C.R.C.), and the Division of Infectious Diseases, Department of Pediatrics (T.R.), University of California, San Francisco, and the San Francisco Department of Public Health (Y.-H.C.), San Francisco, the Division of Epidemiology and Biostatistics, the School of Public Health, University of California, Berkeley (J.S., M.L., M.P.), and Gilead Sciences, Foster City (J.F.R.) - all in California; the School of Public Health and Health Sciences, University of Massachusetts, Amherst (L.B.B.); the Infectious Diseases Research Collaboration (D.K., J. Kabami, M.A., E.S., D.M.B., F.M., A.O., H.N., J. Kironde, S.O., G.L.) and the School of Medicine, Makerere University (M.R.K.), Kampala, Uganda; Kenya Medical Research Institute, Nairobi (J. Ayieko, N.S., K.K., W.O., J. Achando, B.A., E.M.W., P.O., E.B.); Perelman School of Medicine, University of Pennsylvania, Philadelphia (H.T.); and the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD (M.B.).'}, {'ForeName': 'Craig R', 'Initials': 'CR', 'LastName': 'Cohen', 'Affiliation': 'From the Division of HIV, Infectious Diseases, and Global Medicine, Department of Medicine (D.V.H., T.D.C., T.L., G.C., V.J., D.B., K.S., C.K., L.B., C.M.), the Division of Prevention Science, Department of Medicine (E.D.C., S.B.S., A.P.), the Department of Obstetrics, Gynecology, and Reproductive Sciences (C.S.C., R.B., M.G., C.R.C.), and the Division of Infectious Diseases, Department of Pediatrics (T.R.), University of California, San Francisco, and the San Francisco Department of Public Health (Y.-H.C.), San Francisco, the Division of Epidemiology and Biostatistics, the School of Public Health, University of California, Berkeley (J.S., M.L., M.P.), and Gilead Sciences, Foster City (J.F.R.) - all in California; the School of Public Health and Health Sciences, University of Massachusetts, Amherst (L.B.B.); the Infectious Diseases Research Collaboration (D.K., J. Kabami, M.A., E.S., D.M.B., F.M., A.O., H.N., J. Kironde, S.O., G.L.) and the School of Medicine, Makerere University (M.R.K.), Kampala, Uganda; Kenya Medical Research Institute, Nairobi (J. Ayieko, N.S., K.K., W.O., J. Achando, B.A., E.M.W., P.O., E.B.); Perelman School of Medicine, University of Pennsylvania, Philadelphia (H.T.); and the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD (M.B.).'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Bukusi', 'Affiliation': 'From the Division of HIV, Infectious Diseases, and Global Medicine, Department of Medicine (D.V.H., T.D.C., T.L., G.C., V.J., D.B., K.S., C.K., L.B., C.M.), the Division of Prevention Science, Department of Medicine (E.D.C., S.B.S., A.P.), the Department of Obstetrics, Gynecology, and Reproductive Sciences (C.S.C., R.B., M.G., C.R.C.), and the Division of Infectious Diseases, Department of Pediatrics (T.R.), University of California, San Francisco, and the San Francisco Department of Public Health (Y.-H.C.), San Francisco, the Division of Epidemiology and Biostatistics, the School of Public Health, University of California, Berkeley (J.S., M.L., M.P.), and Gilead Sciences, Foster City (J.F.R.) - all in California; the School of Public Health and Health Sciences, University of Massachusetts, Amherst (L.B.B.); the Infectious Diseases Research Collaboration (D.K., J. Kabami, M.A., E.S., D.M.B., F.M., A.O., H.N., J. Kironde, S.O., G.L.) and the School of Medicine, Makerere University (M.R.K.), Kampala, Uganda; Kenya Medical Research Institute, Nairobi (J. Ayieko, N.S., K.K., W.O., J. Achando, B.A., E.M.W., P.O., E.B.); Perelman School of Medicine, University of Pennsylvania, Philadelphia (H.T.); and the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD (M.B.).'}, {'ForeName': 'Moses R', 'Initials': 'MR', 'LastName': 'Kamya', 'Affiliation': 'From the Division of HIV, Infectious Diseases, and Global Medicine, Department of Medicine (D.V.H., T.D.C., T.L., G.C., V.J., D.B., K.S., C.K., L.B., C.M.), the Division of Prevention Science, Department of Medicine (E.D.C., S.B.S., A.P.), the Department of Obstetrics, Gynecology, and Reproductive Sciences (C.S.C., R.B., M.G., C.R.C.), and the Division of Infectious Diseases, Department of Pediatrics (T.R.), University of California, San Francisco, and the San Francisco Department of Public Health (Y.-H.C.), San Francisco, the Division of Epidemiology and Biostatistics, the School of Public Health, University of California, Berkeley (J.S., M.L., M.P.), and Gilead Sciences, Foster City (J.F.R.) - all in California; the School of Public Health and Health Sciences, University of Massachusetts, Amherst (L.B.B.); the Infectious Diseases Research Collaboration (D.K., J. Kabami, M.A., E.S., D.M.B., F.M., A.O., H.N., J. Kironde, S.O., G.L.) and the School of Medicine, Makerere University (M.R.K.), Kampala, Uganda; Kenya Medical Research Institute, Nairobi (J. Ayieko, N.S., K.K., W.O., J. Achando, B.A., E.M.W., P.O., E.B.); Perelman School of Medicine, University of Pennsylvania, Philadelphia (H.T.); and the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD (M.B.).'}, {'ForeName': 'Maya', 'Initials': 'M', 'LastName': 'Petersen', 'Affiliation': 'From the Division of HIV, Infectious Diseases, and Global Medicine, Department of Medicine (D.V.H., T.D.C., T.L., G.C., V.J., D.B., K.S., C.K., L.B., C.M.), the Division of Prevention Science, Department of Medicine (E.D.C., S.B.S., A.P.), the Department of Obstetrics, Gynecology, and Reproductive Sciences (C.S.C., R.B., M.G., C.R.C.), and the Division of Infectious Diseases, Department of Pediatrics (T.R.), University of California, San Francisco, and the San Francisco Department of Public Health (Y.-H.C.), San Francisco, the Division of Epidemiology and Biostatistics, the School of Public Health, University of California, Berkeley (J.S., M.L., M.P.), and Gilead Sciences, Foster City (J.F.R.) - all in California; the School of Public Health and Health Sciences, University of Massachusetts, Amherst (L.B.B.); the Infectious Diseases Research Collaboration (D.K., J. Kabami, M.A., E.S., D.M.B., F.M., A.O., H.N., J. Kironde, S.O., G.L.) and the School of Medicine, Makerere University (M.R.K.), Kampala, Uganda; Kenya Medical Research Institute, Nairobi (J. Ayieko, N.S., K.K., W.O., J. Achando, B.A., E.M.W., P.O., E.B.); Perelman School of Medicine, University of Pennsylvania, Philadelphia (H.T.); and the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD (M.B.).'}]",The New England journal of medicine,['10.1056/NEJMoa1809866'] 3181,18558665,Randomized phase III study comparing irinotecan combined with 5-fluorouracil and folinic acid to cisplatin combined with 5-fluorouracil in chemotherapy naive patients with advanced adenocarcinoma of the stomach or esophagogastric junction.,"BACKGROUND We aimed to establish the superiority (or noninferiority if superiority was not achieved) in terms of time to progression (TTP) of irinotecan/5-fluorouracil (IF) over cisplatin/5-fluorouracil (CF) in chemonaive patients with adenocarcinoma of the stomach/esophagogastric junction. PATIENTS AND METHODS Patients received either IF: i.v. irinotecan 80 mg/m(2) 30 min, folinic acid 500 mg/m(2) 2 h, 5-fluorouracil (5-FU) 2000 mg/m(2) 22 h, for 6/7 weeks or CF: cisplatin 100 mg/m(2) 1-3 h, with 5-FU 1000 mg/m(2)/day 24 h, days 1-5, every 4 weeks. RESULTS In all, 333 patients were randomized and treated (IF 170, CF 163). Patient characteristics were balanced except more IF patients had Karnofsky performance status 100%. TTP for IF was 5.0 months [95% confidence interval (CI) 3.8-5.8] and 4.2 months (95% CI 3.7-5.5) for CF (P = 0.088). Overall survival (OS) was 9.0 versus 8.7 months, response rate 31.8% versus 25.8%, time to treatment failure (TTF) 4.0 versus 3.4 months for IF and CF, respectively. The difference in TTF was statistically significant (P = 0.018). IF was better in terms of toxic deaths (0.6% versus 3%), discontinuation for toxicity (10.0% versus 21.5%), severe neutropenia, thrombocytopenia and stomatitis, but not diarrhea. CONCLUSION IF did not yield a significant TTP or OS superiority over CF, and the results of noninferiority of IF were borderline. However, IF may provide a viable, platinum-free front-line treatment alternative for metastatic gastric cancer.",2008,TTP for IF was 5.0 months [95% confidence interval (CI) 3.8-5.8] and 4.2 months (95% CI 3.7-5.5) for CF (P = 0.088).,"['chemonaive patients with adenocarcinoma of the stomach/esophagogastric junction', '333 patients', 'chemotherapy naive patients with advanced adenocarcinoma of the stomach or esophagogastric junction', 'Patients received either IF: i.v']","['irinotecan 80 mg/m(2', '5-fluorouracil (5-FU', 'folinic acid', 'irinotecan combined with 5-fluorouracil and folinic acid to cisplatin combined with 5-fluorouracil', 'irinotecan/5-fluorouracil (IF) over cisplatin/5-fluorouracil (CF', 'CF: cisplatin 100 mg/m(2) 1-3 h, with 5-FU 1000 mg/m(2)/day 24 h', 'TTP']","['toxic deaths', 'response rate', 'discontinuation for toxicity', 'TTP or OS superiority', 'severe neutropenia, thrombocytopenia and stomatitis', 'TTF', 'Overall survival (OS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001418', 'cui_str': 'Adenoma, Malignant'}, {'cui': 'C3714551', 'cui_str': 'Stomach structure (body structure)'}, {'cui': 'C0014871', 'cui_str': 'Gastroesophageal Junction'}, {'cui': 'C4517724', 'cui_str': 'Three hundred and thirty-three'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}]","[{'cui': 'C0123931', 'cui_str': 'irinotecan'}, {'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0023413', 'cui_str': 'Leucovorin'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0539005', 'cui_str': 'M-1 (alpha)'}, {'cui': 'C0041119', 'cui_str': 'Hydrogen-3'}, {'cui': 'C1883310', 'cui_str': '1000 (qualifier value)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0034155', 'cui_str': 'Moschkowitz Disease'}]","[{'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0034155', 'cui_str': 'Moschkowitz Disease'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}, {'cui': 'C0040034', 'cui_str': 'Thrombopenia'}, {'cui': 'C0038362', 'cui_str': 'Stomatitis'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",333.0,0.211351,TTP for IF was 5.0 months [95% confidence interval (CI) 3.8-5.8] and 4.2 months (95% CI 3.7-5.5) for CF (P = 0.088).,"[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Dank', 'Affiliation': 'Semmelweis University, Budapest, Hungary.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Zaluski', 'Affiliation': 'Wielkopolskie Centrum Onkologii Poznan, Poznan, Poland.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Barone', 'Affiliation': 'Catholic University of Sacred Heart, Rome, Italy.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Valvere', 'Affiliation': 'Estonian Oncology Center, Tallinn, Estonia.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Yalcin', 'Affiliation': 'Hacettepe University Medical Faculty Institute of Oncology, Sihhiye, Ankara, Turkey.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Peschel', 'Affiliation': 'III Med. Klinik, Munich, Germany.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Wenczl', 'Affiliation': 'Markusovszky County Hospital, Szombathely, Markusovszky, Hungary.'}, {'ForeName': 'E', 'Initials': 'E', 'LastName': 'Goker', 'Affiliation': 'Ege University Medical School, Izmir, Turkey.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Cisar', 'Affiliation': 'Pfizer, New York, NY, USA.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Wang', 'Affiliation': 'Pfizer, New York, NY, USA.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Bugat', 'Affiliation': 'Institut Claudius Regaud, Toulouse, France. Electronic address: bugat@icr.fnclcc.fr.'}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdn166'] 3182,31906407,Physical Fitness as Part of the Health and Well-Being of Students Participating in Physical Education Lessons Indoors and Outdoors.,"The analysis of existing information on physical activity and fitness as elements of health and well-being reveals that they are achieved particularly effectively in contact with nature. Physical education lessons outdoors, as a form of healthy training, have been performed in numerous countries for years, providing a response to the traditional indoor model of this kind of education. The purpose of this paper is to clarify the relationship between the participation of students in outdoor and indoor lesson activities and the change in their physical fitness. 220 students participated in an experimental study. The experimental group, which did exercise usually in open spaces, included 49 boys and 54 girls. The control group, which exercised inside school, consisted of 63 boys and 54 girls. The study period lasted two years and involved the fifth and sixth form of primary school. Experimental group subjects were 11.26 years old (±0.32) during the initial test, and the control group individuals were 11.28 years (±0.32). During the final test, the average ages of experimental group subjects was 12.96 years (±0.32), and 12.98 years (±0.32) in the control group. The International Physical Activity Test was applied in the study. The differences between the levels of particular components of physical fitness were not statistically significant during the initial measurement ( p -values ranged from p = 0.340 to p = 0.884). After two years of outdoor physical education lessons, there was revealed a considerable increase in the speed, jumping ability, and aerobic endurance of the students. Statistically significant differences were observed in these three tests, including running speed ( p = 0.001), legs power ( p = 0.001), and endurance ( p = 0.000). The findings encourage one to continue pedagogical experiments regarding physical activity in outdoor natural environments.",2020,"Statistically significant differences were observed in these three tests, including running speed ( p = 0.001), legs power ( p = 0.001), and endurance ( p = 0.000).","['Students Participating in Physical Education Lessons Indoors and Outdoors', '220 students participated in an experimental study', '63 boys and 54 girls', '49 boys and 54 girls', 'Experimental group subjects were 11.26 years old (±0.32) during the initial test, and the control group individuals were 11.28 years (±0.32']",[],"['legs power', 'speed, jumping ability, and aerobic endurance', 'running speed', 'levels of particular components of physical fitness']","[{'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0031805', 'cui_str': 'Physical Education'}, {'cui': 'C4517650', 'cui_str': '220 (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0870221', 'cui_str': 'Boys'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}]",[],"[{'cui': 'C0560453', 'cui_str': 'Does jump (finding)'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0518031', 'cui_str': 'Endurance capacity'}, {'cui': 'C0600140', 'cui_str': 'Does run (finding)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0449432', 'cui_str': 'Component (attribute)'}, {'cui': 'C0031812', 'cui_str': 'Physical Fitness'}]",,0.0120776,"Statistically significant differences were observed in these three tests, including running speed ( p = 0.001), legs power ( p = 0.001), and endurance ( p = 0.000).","[{'ForeName': 'Marcin', 'Initials': 'M', 'LastName': 'Pasek', 'Affiliation': 'Faculty of Physical Culture, Gdansk University of Physical Education and Sport, 80-336 Gdansk, Poland.'}, {'ForeName': 'Mirosława', 'Initials': 'M', 'LastName': 'Szark-Eckardt', 'Affiliation': 'Institute of Physical Education, Kazimierz Wielki University in Bydgoszcz, 85-064 Bydgoszcz, Poland.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Wilk', 'Affiliation': 'Faculty of Public Health, Jozef Rusiecki University College, 11-041 Olsztyn, Poland.'}, {'ForeName': 'Jolanta', 'Initials': 'J', 'LastName': 'Zuzda', 'Affiliation': 'Faculty of Management, Bialystok University of Technology, 16-001 Kleosin, Poland.'}, {'ForeName': 'Hanna', 'Initials': 'H', 'LastName': 'Żukowska', 'Affiliation': 'Institute of Physical Education, Kazimierz Wielki University in Bydgoszcz, 85-064 Bydgoszcz, Poland.'}, {'ForeName': 'Monika', 'Initials': 'M', 'LastName': 'Opanowska', 'Affiliation': 'Faculty of Physical Culture, Gdansk University of Physical Education and Sport, 80-336 Gdansk, Poland.'}, {'ForeName': 'Michalina', 'Initials': 'M', 'LastName': 'Kuska', 'Affiliation': 'Institute of Physical Education, Kazimierz Wielki University in Bydgoszcz, 85-064 Bydgoszcz, Poland.'}, {'ForeName': 'Remigiusz', 'Initials': 'R', 'LastName': 'Dróżdż', 'Affiliation': 'Faculty of Physical Culture, Gdansk University of Physical Education and Sport, 80-336 Gdansk, Poland.'}, {'ForeName': 'Małgorzata', 'Initials': 'M', 'LastName': 'Kuśmierczyk', 'Affiliation': 'Faculty of Public Health, Jozef Rusiecki University College, 11-041 Olsztyn, Poland.'}, {'ForeName': 'Wojciech', 'Initials': 'W', 'LastName': 'Sakłak', 'Affiliation': 'Faculty of Physical Culture, Gdansk University of Physical Education and Sport, 80-336 Gdansk, Poland.'}, {'ForeName': 'Ewa', 'Initials': 'E', 'LastName': 'Kupcewicz', 'Affiliation': 'Faculty of Health Sciences, Collegium Medicum University of Warmia and Mazury in Olsztyn, 10-719 Olsztyn, Poland.'}]",International journal of environmental research and public health,['10.3390/ijerph17010309'] 3183,32008850,Efficacy and safety of edoxaban in patients with diabetes mellitus in the ENGAGE AF-TIMI 48 trial.,"BACKGROUND Diabetes mellitus is an independent risk factor for stroke and atrial fibrillation. Therefore, the risk/benefit profile of the oral factor Xa inhibitor edoxaban stratified by diabetes is of clinical interest. METHODS 21,105 patients enrolled in ENGAGE AF-TIMI 48 were stratified into 2 pre-specified groups: without (N = 13,481) and with diabetes (N = 7,624). RESULTS On average, patients with diabetes were younger, and had a higher body mass index, CHA 2 DS 2 -VASc score and baseline endogenous Factor Xa activity. After multivariate adjustments, patients with diabetes had a similar rate of stroke and systemic embolism compared to those without diabetes (adjusted hazard ratio (HR adj ) 1.08; 95% confidence interval (CI) 0.94-1.24; p = 0.28). However, the risk of major bleeding was significantly higher in patients with diabetes (HR adj 1.28; 95% CI 1.14-1.44; p < 0.001). The treatment effect of edoxaban (vs warfarin) was not modified by diabetes (all p-interactions > 0.05), a finding supported by the preserved edoxaban concentrations and inhibition of Factor Xa regardless of diabetes. The HRs of stroke and systemic embolism in patients receiving the higher-dose edoxaban regimen vs warfarin were 0.93 and 0.84 (p-interaction = 0.54) in those with and without diabetes respectively. The higher-dose edoxaban regimen reduced major bleeding (by 19-21%) and cardiovascular death (by 7-17%) regardless of diabetes (p-interactions = 0.81 and 0.33 respectively). CONCLUSION Patients with diabetes in ENGAGE AF-TIMI 48 had higher bleeding risk, but after adjustment similar stroke risk, compared to those without diabetes. The higher-dose edoxaban regimen had similar efficacy compared to warfarin, while reducing bleeding and cardiovascular mortality, irrespective of diabetes.",2020,"The higher-dose edoxaban regimen had similar efficacy compared to warfarin, while reducing bleeding and cardiovascular mortality, irrespective of diabetes.","['patients with diabetes mellitus in the ENGAGE AF-TIMI 48 trial', '21,105 patients enrolled in ENGAGE AF-TIMI 48 were stratified into 2 pre-specified groups: without (N\xa0=\xa013,481) and with diabetes (N\xa0=\xa07,624']","['edoxaban', 'warfarin', 'Xa inhibitor edoxaban', 'edoxaban (vs warfarin']","['HRs of stroke and systemic embolism', 'bleeding and cardiovascular mortality, irrespective of diabetes', 'risk of major bleeding', 'higher body mass index, CHA 2 DS 2 -VASc score and baseline endogenous Factor Xa activity', 'Efficacy and safety', 'bleeding risk', 'major bleeding', 'rate of stroke and systemic embolism', 'cardiovascular death']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0425152', 'cui_str': 'Engaged to be married (finding)'}, {'cui': 'C0205363', 'cui_str': 'Stratified (qualifier value)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C2975435', 'cui_str': 'edoxaban'}, {'cui': 'C0043031', 'cui_str': 'Warfarin'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}]","[{'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0013922', 'cui_str': 'Embolism'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205227', 'cui_str': 'Endogenous (qualifier value)'}, {'cui': 'C0015520', 'cui_str': 'Factor 10A'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",21105.0,0.0918785,"The higher-dose edoxaban regimen had similar efficacy compared to warfarin, while reducing bleeding and cardiovascular mortality, irrespective of diabetes.","[{'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Plitt', 'Affiliation': 'Mount Sinai Heart, New York, NY, United States of America.'}, {'ForeName': 'Christian T', 'Initials': 'CT', 'LastName': 'Ruff', 'Affiliation': ""TIMI Study Group, Cardiovascular Division, Brigham and Women's Hospital, Boston, MA, United States of America.""}, {'ForeName': 'Assen', 'Initials': 'A', 'LastName': 'Goudev', 'Affiliation': 'UMHAT ""Tzaritza Yoanna-ISUL"" EAD Clinic of Cardiology, Sofia, Bulgaria.'}, {'ForeName': 'Joao', 'Initials': 'J', 'LastName': 'Morais', 'Affiliation': ""Santo Andre's Hospital, Cardiology Division, Leiria, Portugal.""}, {'ForeName': 'Miodrag C', 'Initials': 'MC', 'LastName': 'Ostojic', 'Affiliation': 'School of Medicine University of Belgrade, Belgrade, Serbia.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Grosso', 'Affiliation': 'Daiichi Sankyo Inc., Basking Ridge, NJ, United States of America.'}, {'ForeName': 'Hans J', 'Initials': 'HJ', 'LastName': 'Lanz', 'Affiliation': 'Daiichi Sankyo Europe GmbH, Munich, Germany.'}, {'ForeName': 'Jeong-Gun', 'Initials': 'JG', 'LastName': 'Park', 'Affiliation': ""TIMI Study Group, Cardiovascular Division, Brigham and Women's Hospital, Boston, MA, United States of America.""}, {'ForeName': 'Elliott M', 'Initials': 'EM', 'LastName': 'Antman', 'Affiliation': ""TIMI Study Group, Cardiovascular Division, Brigham and Women's Hospital, Boston, MA, United States of America.""}, {'ForeName': 'Eugene', 'Initials': 'E', 'LastName': 'Braunwald', 'Affiliation': ""TIMI Study Group, Cardiovascular Division, Brigham and Women's Hospital, Boston, MA, United States of America.""}, {'ForeName': 'Robert P', 'Initials': 'RP', 'LastName': 'Giugliano', 'Affiliation': ""TIMI Study Group, Cardiovascular Division, Brigham and Women's Hospital, Boston, MA, United States of America. Electronic address: rgiugliano@bwh.harvard.edu.""}]",International journal of cardiology,['10.1016/j.ijcard.2020.01.009'] 3184,32011286,Outcomes of predefined optimisation criteria for intravascular ultrasound guidance of left main stenting.,"AIMS This study sought to investigate the prognostic effect of a protocol with optimisation targets for intravascular ultrasound (IVUS)-guided left main (LM) revascularisation. METHODS AND RESULTS A protocol was prospectively applied for IVUS-guided LM revascularisation (IVUS-PRO group) including predefined optimisation targets. Using propensity score matching, we selected as control groups patients with angiography-guided PCI (ANGIO group) and IVUS-guided PCI (IVUS group) from a large multicentre registry. The primary endpoint was a composite of cardiac death, LM-related infarction and LM revascularisation at 12 months. In each group, 124 patients with comparable characteristics were included. The incidence of the primary outcome was significantly higher in the ANGIO group compared to the IVUS-PRO group (12.9% vs 4.8%, HR 0.35, 95% CI: 0.15 to 0.82, p=0.02), but not with respect to the IVUS group (12.9% vs 8%, HR 0.51, 95% CI: 0.20 to 1.22, p=0.1), driven by a lower rate of LM revascularisation (8% in the ANGIO group, 6.4% in the IVUS group and 3.2% in the IVUS-PRO group). IVUS-PRO resulted in being an independent risk predictor (HR 0.45, 95% CI: 0.15 to 0.98; p=0.041). CONCLUSIONS IVUS guidance of LM stenting provides prognostic benefit with respect to the use of angiography alone, particularly when following a protocol with these predefined optimisation criteria.",2020,"Incidence of primary outcome was significantly higher in ANGIO group compared to IVUS-PRO group (12.9% vs. 4.8%, HR 0.35 CI 95% 0.15 to 0.82, p=0.02), but not with respect to the IVUS group (12.9% vs. 8%, HR 0.51 CI95% 0.20 to 1.22, p=0.1), driven by a lower rate of LM revascularization (8% in ANGIO group, 6.4% in IVUS group and 3.2% in IVUS-PRO group).",['124 patients with comparable characteristics were included'],"['LM stenting', 'intravascular ultrasound (IVUS) guided left main (LM) revascularization', 'IVUS-PRO', 'angiography guided PCI (ANGIO group) and IVUS guided PCI (IVUS group']","['rate of LM revascularization', 'Incidence of primary outcome', 'composite of cardiac death, LM related infarction and LM revascularization']","[{'cui': 'C4517553', 'cui_str': '124 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C0442123', 'cui_str': 'Intravascular (qualifier value)'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}, {'cui': 'C0205225', 'cui_str': 'Principal (qualifier value)'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}, {'cui': 'C0002978', 'cui_str': 'Angiography'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0203108', 'cui_str': 'Pyelogram'}]","[{'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0376297', 'cui_str': 'Cardiac Death'}, {'cui': 'C0021308', 'cui_str': 'Infarction'}]",124.0,0.0401253,"Incidence of primary outcome was significantly higher in ANGIO group compared to IVUS-PRO group (12.9% vs. 4.8%, HR 0.35 CI 95% 0.15 to 0.82, p=0.02), but not with respect to the IVUS group (12.9% vs. 8%, HR 0.51 CI95% 0.20 to 1.22, p=0.1), driven by a lower rate of LM revascularization (8% in ANGIO group, 6.4% in IVUS group and 3.2% in IVUS-PRO group).","[{'ForeName': 'Jose Maria', 'Initials': 'JM', 'LastName': 'de la Torre Hernandez', 'Affiliation': 'Hospital Universitario Marqués de Valdecilla, IDIVAL, Santander, Spain.'}, {'ForeName': 'Tamara', 'Initials': 'T', 'LastName': 'Garcia Camarero', 'Affiliation': ''}, {'ForeName': 'José Antonio', 'Initials': 'JA', 'LastName': 'Baz Alonso', 'Affiliation': ''}, {'ForeName': 'Joan Antoni', 'Initials': 'JA', 'LastName': 'Gómez-Hospital', 'Affiliation': ''}, {'ForeName': 'Gabriela', 'Initials': 'G', 'LastName': 'Veiga Fernandez', 'Affiliation': ''}, {'ForeName': 'Dae-Hyun', 'Initials': 'DH', 'LastName': 'Lee Hwang', 'Affiliation': ''}, {'ForeName': 'Fermin', 'Initials': 'F', 'LastName': 'Sainz Laso', 'Affiliation': ''}, {'ForeName': 'Ángel', 'Initials': 'Á', 'LastName': 'Sánchez-Recalde', 'Affiliation': ''}, {'ForeName': 'Armando', 'Initials': 'A', 'LastName': 'Perez de Prado', 'Affiliation': ''}, {'ForeName': 'Iñigo', 'Initials': 'I', 'LastName': 'Lozano Martínez-Luengas', 'Affiliation': ''}, {'ForeName': 'Felipe', 'Initials': 'F', 'LastName': 'Hernandez Hernandez', 'Affiliation': ''}, {'ForeName': 'Sofia', 'Initials': 'S', 'LastName': 'Gonzalez Lizarbe', 'Affiliation': ''}, {'ForeName': 'Lola', 'Initials': 'L', 'LastName': 'Gutierrez Alonso', 'Affiliation': ''}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Zueco', 'Affiliation': ''}, {'ForeName': 'Fernando', 'Initials': 'F', 'LastName': 'Alfonso', 'Affiliation': ''}]",EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology,['10.4244/EIJ-D-19-01057'] 3185,31836203,Corneal epithelial thickness and corneal curvature changes during the day: The effects of daily disposable contact lens wear.,"PURPOSE To evaluate the changes in corneal epithelial thickness and corneal anterior and posterior curvatures during the day, and the effect of wearing daily disposable soft contact lenses. METHODS Thirty-two healthy volunteers were enrolled in a randomized crossover study. At the baseline visit, corneal and epithelial thickness maps (OCT; Optovue, Inc., Fremont, CA, USA) and keratometric measurements (Pentacam, Oculus, GmbH, Germany) were performed in the morning and in the afternoon (8 hours after). Then, each subject was fitted with the following brands of daily disposable contact lenses in random order: Dailies Total 1 (Delefilcon A), Dailies Aqua Comfort (Nelfilcon A), TruEye (Narafilcon A) and Biotrue Oneday (Nesofilcon A) on different days. All fitted lenses had a power of -3.00 diopters (D). Measurements were repeated before putting the contact lens on and after an-eight-hour contact lens wear. RESULTS With no lens wear, the anterior topographic indices showed significant steepening [Kflat: p < 0.0001; Ksteep: p < 0.0001 and maximum keratometry value (Kmax): p = 0.04] and the corneal thickness significantly decreased in the central and temporal portion of the cornea in the afternoon. There were no significant changes in the posterior topographical indices and corneal epithelial thickness. With contact lens wear, no significant change occurred in the corneal and epithelial thickness, and the anterior and posterior curvatures during the day (all p values >0.05). There was no statistically significant difference in the epithelial thickness among the groups wearing different contact lens types (p > 0.05). CONCLUSIONS Anterior corneal topographic indices steepen depending on the natural diurnal variations. Daily wear of soft contact lenses appears to mask this steepening. The corneal epithelial thickness is not affected by daily disposable soft contact lenses.",2020,"With contact lens wear, no significant change occurred in the corneal and epithelial thickness, and the anterior and posterior curvatures during the day (all p values >0.05).",['Thirty-two healthy volunteers'],"['daily disposable contact lens wear', 'soft contact lenses']","['Corneal epithelial thickness and corneal curvature changes', 'Dailies Total 1 (Delefilcon A), Dailies Aqua Comfort (Nelfilcon A), TruEye (Narafilcon A) and Biotrue', 'corneal thickness', 'epithelial thickness', 'corneal epithelial thickness and corneal anterior and posterior curvatures', 'corneal epithelial thickness', 'corneal and epithelial thickness maps (OCT; Optovue, Inc., Fremont, CA, USA) and keratometric measurements (Pentacam, Oculus, GmbH, Germany', 'posterior topographical indices and corneal epithelial thickness', 'corneal and epithelial thickness, and the anterior and posterior curvatures']","[{'cui': 'C0450357', 'cui_str': '32 (qualifier value)'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0009836', 'cui_str': 'Contact Lenses'}, {'cui': 'C0009838', 'cui_str': 'Soft Contact Lenses'}]","[{'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0429493', 'cui_str': 'Corneal thickness (observable entity)'}, {'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C0205095', 'cui_str': 'Behind (qualifier value)'}, {'cui': 'C0024779', 'cui_str': 'Map'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0017480', 'cui_str': 'Germany'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}]",32.0,0.0226964,"With contact lens wear, no significant change occurred in the corneal and epithelial thickness, and the anterior and posterior curvatures during the day (all p values >0.05).","[{'ForeName': 'Semra Akkaya', 'Initials': 'SA', 'LastName': 'Turhan', 'Affiliation': 'University of Marmara, School of Medicine, Department of Ophthalmology, Istanbul, Turkey. Electronic address: semraakkaya85@hotmail.com.'}, {'ForeName': 'Didem Dizdar', 'Initials': 'DD', 'LastName': 'Yigit', 'Affiliation': 'University of Marmara, School of Medicine, Department of Ophthalmology, Istanbul, Turkey. Electronic address: drdidemdizdar@gmail.com.'}, {'ForeName': 'Ebru', 'Initials': 'E', 'LastName': 'Toker', 'Affiliation': 'University of Marmara, School of Medicine, Department of Ophthalmology, Istanbul, Turkey. Electronic address: dretoker@gmail.com.'}]",Contact lens & anterior eye : the journal of the British Contact Lens Association,['10.1016/j.clae.2019.11.017'] 3186,32015491,"Clinical significance of TP53, BIRC3, ATM and MAPK-ERK genes in chronic lymphocytic leukaemia: data from the randomised UK LRF CLL4 trial.","Despite advances in chronic lymphocytic leukaemia (CLL) treatment, globally chemotherapy remains a central treatment modality, with chemotherapy trials representing an invaluable resource to explore disease-related/genetic features contributing to long-term outcomes. In 499 LRF CLL4 cases, a trial with >12 years follow-up, we employed targeted resequencing of 22 genes, identifying 623 mutations. After background mutation rate correction, 11/22 genes were recurrently mutated at frequencies between 3.6% (NFKBIE) and 24% (SF3B1). Mutations beyond Sanger resolution (<12% VAF) were observed in all genes, with KRAS mutations principally composed of these low VAF variants. Firstly, employing orthogonal approaches to confirm <12% VAF TP53 mutations, we assessed the clinical impact of TP53 clonal architecture. Whilst ≥ 12% VAF TP53mut cases were associated with reduced PFS and OS, we could not demonstrate a difference between <12% VAF TP53 mutations and either wild type or ≥12% VAF TP53mut cases. Secondly, we identified biallelic BIRC3 lesions (mutation and deletion) as an independent marker of inferior PFS and OS. Finally, we observed that mutated MAPK-ERK genes were independent markers of poor OS in multivariate survival analysis. In conclusion, our study supports using targeted resequencing of expanded gene panels to elucidate the prognostic impact of gene mutations.",2020,"After background mutation rate correction, 11/22 genes were recurrently mutated at frequencies between 3.6% (NFKBIE) and 24% (SF3B1).","['chronic lymphocytic leukaemia (CLL', 'chronic lymphocytic leukaemia', '499 LRF CLL4 cases, a trial with >12 years follow-up, we employed targeted resequencing of 22 genes, identifying 623 mutations']",[],"['PFS and OS', 'Mutations beyond Sanger resolution', 'biallelic BIRC3 lesions (mutation and deletion']","[{'cui': 'C0023434', 'cui_str': 'Lymphoma, Small Lymphocytic'}, {'cui': 'C0868928', 'cui_str': 'Case - situation (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0017337', 'cui_str': 'Genes'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C0026882', 'cui_str': 'Mutation'}]",[],"[{'cui': 'C0026882', 'cui_str': 'Mutation'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C1442161', 'cui_str': 'Deletion (morphologic abnormality)'}]",,0.0594031,"After background mutation rate correction, 11/22 genes were recurrently mutated at frequencies between 3.6% (NFKBIE) and 24% (SF3B1).","[{'ForeName': 'Stuart J', 'Initials': 'SJ', 'LastName': 'Blakemore', 'Affiliation': 'Academic Unit of Cancer Sciences, Faculty of Medicine, University of Southampton, Southampton, UK.'}, {'ForeName': 'Ruth', 'Initials': 'R', 'LastName': 'Clifford', 'Affiliation': 'Oxford National Institute for Health Research Biomedical Research Centre and Department of Oncology, University of Oxford, Oxford, UK.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Parker', 'Affiliation': 'Academic Unit of Cancer Sciences, Faculty of Medicine, University of Southampton, Southampton, UK.'}, {'ForeName': 'Pavlos', 'Initials': 'P', 'LastName': 'Antoniou', 'Affiliation': 'Oxford National Institute for Health Research Biomedical Research Centre and Department of Oncology, University of Oxford, Oxford, UK.'}, {'ForeName': 'Ewa', 'Initials': 'E', 'LastName': 'Stec-Dziedzic', 'Affiliation': 'Oxford National Institute for Health Research Biomedical Research Centre and Department of Oncology, University of Oxford, Oxford, UK.'}, {'ForeName': 'Marta', 'Initials': 'M', 'LastName': 'Larrayoz', 'Affiliation': 'Academic Unit of Cancer Sciences, Faculty of Medicine, University of Southampton, Southampton, UK.'}, {'ForeName': 'Zadie', 'Initials': 'Z', 'LastName': 'Davis', 'Affiliation': 'Department of Molecular Pathology, Royal Bournemouth Hospital, Bournemouth, UK.'}, {'ForeName': 'Latha', 'Initials': 'L', 'LastName': 'Kadalyayil', 'Affiliation': 'Genetic Epidemiology and Bioinformatics, Faculty of Medicine, University of Southampton, Southampton, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Colins', 'Affiliation': 'Genetic Epidemiology and Bioinformatics, Faculty of Medicine, University of Southampton, Southampton, UK.'}, {'ForeName': 'Pauline', 'Initials': 'P', 'LastName': 'Robbe', 'Affiliation': 'Oxford National Institute for Health Research Biomedical Research Centre and Department of Oncology, University of Oxford, Oxford, UK.'}, {'ForeName': 'Dimitris', 'Initials': 'D', 'LastName': 'Vavoulis', 'Affiliation': 'Oxford National Institute for Health Research Biomedical Research Centre and Department of Oncology, University of Oxford, Oxford, UK.'}, {'ForeName': 'Jade', 'Initials': 'J', 'LastName': 'Forster', 'Affiliation': 'Academic Unit of Cancer Sciences, Faculty of Medicine, University of Southampton, Southampton, UK.'}, {'ForeName': 'Louise', 'Initials': 'L', 'LastName': 'Carr', 'Affiliation': 'Academic Unit of Cancer Sciences, Faculty of Medicine, University of Southampton, Southampton, UK.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Morilla', 'Affiliation': 'Division of Molecular Pathology, The Institute of Cancer Research, London, UK.'}, {'ForeName': 'Monica', 'Initials': 'M', 'LastName': 'Else', 'Affiliation': 'Division of Molecular Pathology, The Institute of Cancer Research, London, UK.'}, {'ForeName': 'Dean', 'Initials': 'D', 'LastName': 'Bryant', 'Affiliation': 'Academic Unit of Cancer Sciences, Faculty of Medicine, University of Southampton, Southampton, UK.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'McCarthy', 'Affiliation': 'Department of Molecular Pathology, Royal Bournemouth Hospital, Bournemouth, UK.'}, {'ForeName': 'Renata J', 'Initials': 'RJ', 'LastName': 'Walewska', 'Affiliation': 'Department of Molecular Pathology, Royal Bournemouth Hospital, Bournemouth, UK.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Steele', 'Affiliation': 'Academic Unit of Cancer Sciences, Faculty of Medicine, University of Southampton, Southampton, UK.'}, {'ForeName': 'Jacqueline', 'Initials': 'J', 'LastName': 'Chan', 'Affiliation': 'Oxford Gene Technology, Begbroke Science Park, Begbroke, Oxfordshire, UK.'}, {'ForeName': 'Graham', 'Initials': 'G', 'LastName': 'Speight', 'Affiliation': 'Oxford Gene Technology, Begbroke Science Park, Begbroke, Oxfordshire, UK.'}, {'ForeName': 'Tanja', 'Initials': 'T', 'LastName': 'Stankovic', 'Affiliation': 'Institute of Cancer and Genomic Sciences, College of Medical and Dental Services, IBR West, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Mark S', 'Initials': 'MS', 'LastName': 'Cragg', 'Affiliation': 'Academic Unit of Cancer Sciences, Faculty of Medicine, University of Southampton, Southampton, UK.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Catovsky', 'Affiliation': 'Division of Molecular Pathology, The Institute of Cancer Research, London, UK.'}, {'ForeName': 'David G', 'Initials': 'DG', 'LastName': 'Oscier', 'Affiliation': 'Department of Molecular Pathology, Royal Bournemouth Hospital, Bournemouth, UK.'}, {'ForeName': 'Matthew J J', 'Initials': 'MJJ', 'LastName': 'Rose-Zerilli', 'Affiliation': 'Academic Unit of Cancer Sciences, Faculty of Medicine, University of Southampton, Southampton, UK.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Schuh', 'Affiliation': 'Oxford National Institute for Health Research Biomedical Research Centre and Department of Oncology, University of Oxford, Oxford, UK.'}, {'ForeName': 'Jonathan C', 'Initials': 'JC', 'LastName': 'Strefford', 'Affiliation': 'Academic Unit of Cancer Sciences, Faculty of Medicine, University of Southampton, Southampton, UK. jcs@soton.ac.uk.'}]",Leukemia,['10.1038/s41375-020-0723-2'] 3187,31667706,"Glomerular Filtration Rate and Associated Risks of Cardiovascular Events, Mortality, and Severe Hypoglycemia in Patients with Type 2 Diabetes: Secondary Analysis (DEVOTE 11).","INTRODUCTION The associations of chronic kidney disease (CKD) severity, cardiovascular disease (CVD), and insulin with the risks of major adverse cardiovascular events (MACE), mortality, and severe hypoglycemia in patients with type 2 diabetes (T2D) at high cardiovascular (CV) risk are not known. This secondary, pooled analysis of data from the DEVOTE trial examined whether baseline glomerular filtration rate (GFR) categories were associated with a higher risk of these outcomes. METHODS DEVOTE was a treat-to-target, double-blind trial involving 7637 patients with T2D at high CV risk who were randomized to once-daily treatment with either insulin degludec (degludec) or insulin glargine 100 units/mL (glargine U100). Patients with estimated GFR data at baseline (n = 7522) were analyzed following stratification into four GFR categories. RESULTS The risks of MACE, CV death, and all-cause mortality increased with worsening baseline GFR category (P < 0.05), with a trend towards higher rates of severe hypoglycemia. Patients with prior CVD, CKD (estimated GFR < 60 mL/min/m 2 ), or both were at higher risk of MACE, CV death, and all-cause mortality. Only CKD was associated with a higher rate of severe hypoglycemia, and the risk of MACE was higher in patients with CVD than in those with CKD (P  = 0.0003). There were no significant interactions between randomized treatment and GFR category. CONCLUSION The risks of MACE, CV death, and all-cause mortality were higher with lower baseline GFR and with prior CVD, CKD, or both. The relative effects of degludec versus glargine U100 on outcomes were consistent across baseline GFR categories, suggesting that the lower rate of severe hypoglycemia associated with degludec use versus glargine U100 use was independent of baseline GFR category. FUNDING Novo Nordisk.",2020,"The risks of MACE, CV death, and all-cause mortality increased with worsening baseline GFR category (P < 0.05), with a trend towards higher rates of severe hypoglycemia.","['patients with type 2 diabetes (T2D) at high cardiovascular (CV) risk are not known', '7637 patients with T2D at high CV risk', 'Patients with Type 2 Diabetes', 'Patients with estimated GFR data at baseline (n\u2009=\u20097522']","['glargine', 'insulin degludec (degludec) or insulin glargine 100\xa0units/mL (glargine U100']","['severe hypoglycemia', 'chronic kidney disease (CKD) severity, cardiovascular disease (CVD), and insulin with the risks of major adverse cardiovascular events (MACE), mortality, and severe hypoglycemia', 'Glomerular Filtration Rate and Associated Risks of Cardiovascular Events, Mortality, and Severe Hypoglycemia', 'risks of MACE, CV death, and all-cause mortality', 'baseline glomerular filtration rate (GFR) categories', 'rate of severe hypoglycemia', 'risk of MACE']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C4324389', 'cui_str': 'Cardiovascular risk'}, {'cui': 'C0205309', 'cui_str': 'Known (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C4524116', 'cui_str': 'Estimated GFR'}]","[{'cui': 'C0907402', 'cui_str': 'Insulin Glargine'}, {'cui': 'C3491971', 'cui_str': 'insulin degludec'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C2945590', 'cui_str': 'unit/mL'}]","[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C1561643', 'cui_str': 'Chronic Kidney Diseases'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0007222', 'cui_str': 'Cardiovascular Diseases'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0017654', 'cui_str': 'Glomerular Filtration Rate'}, {'cui': 'C0349381', 'cui_str': 'Mace (substance)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}]",,0.164423,"The risks of MACE, CV death, and all-cause mortality increased with worsening baseline GFR category (P < 0.05), with a trend towards higher rates of severe hypoglycemia.","[{'ForeName': 'Aslam', 'Initials': 'A', 'LastName': 'Amod', 'Affiliation': 'Life Chatsmed Garden Hospital and University of KwaZulu-Natal, Durban, South Africa. amod.aslam1@gmail.com.'}, {'ForeName': 'John B', 'Initials': 'JB', 'LastName': 'Buse', 'Affiliation': 'University of North Carolina School of Medicine, Chapel Hill, NC, USA.'}, {'ForeName': 'Darren K', 'Initials': 'DK', 'LastName': 'McGuire', 'Affiliation': 'University of Texas Southwestern Medical Center, Dallas, TX, USA.'}, {'ForeName': 'Thomas R', 'Initials': 'TR', 'LastName': 'Pieber', 'Affiliation': 'Medical University of Graz, Graz, Austria.'}, {'ForeName': 'Rodica', 'Initials': 'R', 'LastName': 'Pop-Busui', 'Affiliation': 'Internal Medicine, Metabolism, Endocrinology and Diabetes, University of Michigan, Ann Arbor, MI, USA.'}, {'ForeName': 'Richard E', 'Initials': 'RE', 'LastName': 'Pratley', 'Affiliation': 'AdventHealth Translational Research Institute for Metabolism and Diabetes, Orlando, FL, USA.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Zinman', 'Affiliation': 'Lunenfeld-Tanenbaum Research Institute, Mt. Sinai Hospital, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Marco Bo', 'Initials': 'MB', 'LastName': 'Hansen', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Jia', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Mark', 'Affiliation': 'Novo Nordisk A/S, Søborg, Denmark.'}, {'ForeName': 'Neil R', 'Initials': 'NR', 'LastName': 'Poulter', 'Affiliation': 'Imperial College London, London, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Diabetes therapy : research, treatment and education of diabetes and related disorders",['10.1007/s13300-019-00715-x'] 3188,19474112,Bone fractures among postmenopausal patients with endocrine-responsive early breast cancer treated with 5 years of letrozole or tamoxifen in the BIG 1-98 trial.,"BACKGROUND To compare the incidence and timing of bone fractures in postmenopausal women treated with 5 years of adjuvant tamoxifen or letrozole for endocrine-responsive early breast cancer in the Breast International Group (BIG) 1-98 trial. METHODS We evaluated 4895 patients allocated to 5 years of letrozole or tamoxifen in the BIG 1-98 trial who received at least some study medication (median follow-up 60.3 months). Bone fracture information (grade, cause, site) was collected every 6 months during trial treatment. RESULTS The incidence of bone fractures was higher among patients treated with letrozole [228 of 2448 women (9.3%)] versus tamoxifen [160 of 2447 women (6.5%)]. The wrist was the most common site of fracture in both treatment groups. Statistically significant risk factors for bone fractures during treatment included age, smoking history, osteoporosis at baseline, previous bone fracture, and previous hormone replacement therapy. CONCLUSIONS Consistent with other trials comparing aromatase inhibitors to tamoxifen, letrozole was associated with an increase in bone fractures. Benefits of superior disease control associated with letrozole and lower incidence of fracture with tamoxifen should be considered with the risk profile for individual patients.",2009,The wrist was the most common site of fracture in both treatment groups.,"['postmenopausal patients with endocrine-responsive early breast cancer treated with 5 years of', 'postmenopausal women treated with 5 years of adjuvant', '4895 patients allocated to 5 years of', 'for endocrine-responsive early breast cancer in the Breast International Group (BIG) 1-98 trial']","['tamoxifen', 'tamoxifen or letrozole', 'letrozole', 'letrozole or tamoxifen', 'tamoxifen, letrozole']","['Bone fractures', 'Bone fracture information (grade, cause, site', 'bone fractures', 'incidence of bone fractures']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205342', 'cui_str': 'Responsive (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0006141', 'cui_str': 'Breast'}, {'cui': 'C0441861', 'cui_str': 'Group 1 (qualifier value)'}]","[{'cui': 'C0039286', 'cui_str': 'Tamoxifen'}, {'cui': 'C0246421', 'cui_str': 'letrozole'}]","[{'cui': 'C0016658', 'cui_str': 'Fractures, Bone'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}]",4895.0,0.0679758,The wrist was the most common site of fracture in both treatment groups.,"[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Rabaglio', 'Affiliation': 'IBCSG Coordinating Center and Inselspital, Bern, Switzerland. Electronic address: manuela.rabaglio@ibcsg.org.'}, {'ForeName': 'Z', 'Initials': 'Z', 'LastName': 'Sun', 'Affiliation': 'IBCSG Statistical Center, Dana-Farber Cancer Institute, Boston, MA.'}, {'ForeName': 'K N', 'Initials': 'KN', 'LastName': 'Price', 'Affiliation': 'IBCSG Statistical Center and Frontier Science and Technology Research Foundation, Boston, MA, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Castiglione-Gertsch', 'Affiliation': 'IBCSG Coordinating Center, Bern.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Hawle', 'Affiliation': 'IBCSG Coordinating Center, Bern.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Thürlimann', 'Affiliation': 'Senology Center of Eastern Switzerland and Swiss Group for Clinical Cancer Research (SAKK), Kantonsspital, St Gallen, Switzerland, Swiss Group for Clinical Cancer Research (SAKK).'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Mouridsen', 'Affiliation': 'Danish Breast Cancer Cooperative Group, Rigshospitalet, Copenhagen, Denmark.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Campone', 'Affiliation': 'Institut du Cancer Nantes Atlantique, CLCC René Gauducheau, Saint Herblain, Fédération Nationale des Centres de Lutte Contre le Cancer, France.'}, {'ForeName': 'J F', 'Initials': 'JF', 'LastName': 'Forbes', 'Affiliation': 'Australian New Zealand Breast Cancer Trials Group, University of Newcastle, Calvary Mater Newcastle, Newcastle, New South Wales, Australia.'}, {'ForeName': 'R J', 'Initials': 'RJ', 'LastName': 'Paridaens', 'Affiliation': 'Department of Medical Oncology, University Hospital Gasthuisberg, Catholic University of Leuven, Leuven, Belgium.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Colleoni', 'Affiliation': 'Research Unit in Medical Senology, Department of Medicine, European Institute of Oncology, Milan, Italy.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Pienkowski', 'Affiliation': 'Cancer Center Maria Sklodowska-Curie Memorial Institute of Oncology, Warsaw, Poland.'}, {'ForeName': 'J-M', 'Initials': 'JM', 'LastName': 'Nogaret', 'Affiliation': 'Department of Mammary and Pelvic Surgery, Jules Bordet Institute; Brussels, Belgium.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Láng', 'Affiliation': 'Department of Medical Oncology, National Institute of Oncology, Budapest, Hungary.'}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Smith', 'Affiliation': 'Breast Unit, The Royal Marsden Hospital, London, UK.'}, {'ForeName': 'R D', 'Initials': 'RD', 'LastName': 'Gelber', 'Affiliation': 'IBCSG Statistical Center, Dana-Farber Cancer Institute, Harvard School of Public Health and Harvard Medical School, Boston, MA, USA.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Goldhirsch', 'Affiliation': 'Department of Medicine, European Institute of Oncology, Milan, Italy; Oncology Institute of Southern Switzerland, Bellinzona, Switzerland.'}, {'ForeName': 'A S', 'Initials': 'AS', 'LastName': 'Coates', 'Affiliation': 'International Breast Cancer Study Group and University of Sydney, Sydney, New South Wales, Australia.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Annals of oncology : official journal of the European Society for Medical Oncology,['10.1093/annonc/mdp033'] 3189,32006699,Evolution of Analgesic Tolerance and Opioid-Induced Hyperalgesia Over 6 Months: Double-Blind Randomized Trial Incorporating Experimental Pain Models.,"Contributors to the ongoing epidemic of prescription opioid abuse, addiction, and death include opioid tolerance, withdrawal symptoms, and possibly opioid-induced hyperalgesia (OIH). Thirty stable chronic nonmalignant pain patients entered a 6-month long, randomized, double-blind, dose-response, 2-center trial of the potent opioid levorphanol, conducted over a decade ago during an era of permissive opioid prescribing. Eleven were taking no opioids at study entry and eleven were taking between 35 and 122 morphine equivalents. Five weeks titration preceded twenty weeks stable dosing. Tolerance and OIH were inferred individually based on chronic pain ratings, brief pain inventory scores, and results of the brief thermal sensitization model at 5 opioid dosing sessions. Seventeen patients completed. The average final daily opioid dose was 132; range 14 to 300; average addition 105 morphine equivalents. After observed dosing, the brief thermal sensitization area of hyperalgesia changed minimally but the painfulness of skin heating was reduced. Weekly 0 to 100 visual analog scale pain ratings (average 64 at study entry, 48 at end titration, 45 at end stable dosing) decreased a median 19%, but 8 completed with higher visual analog scale ratings. Three completers had evidence of both tolerance and hyperalgesia. A fully-powered trial similar to this feasibility study is ethically questionable. A large-scale pragmatic trial is more realistic. TRIAL REGISTRATION: NCT00275249 Evolution of Analgesic Tolerance With Opioids PERSPECTIVE: A double-blind, 6-month, high-dose opioid feasibility trial, completed years ago, provides critically important data for clinically defining analgesic tolerance and OIH. Overall benefit was small, and 18% of patients had evidence of both tolerance and OIH. Future work requires a different approach than a classic randomized controlled trial design.",2020,"After observed dosing, the BTS area of hyperalgesia changed minimally but the painfulness of skin heating was reduced.","['Seventeen patients completed', 'Thirty stable chronic non-malignant pain patients']","['Analgesic Tolerance', 'opioid levorphanol', 'Opioid-Induced Hyperalgesia']","['tolerance and hyperalgesia', 'chronic pain ratings, Brief Pain Inventory scores', 'painfulness of skin heating', 'Tolerance and OIH', 'VAS pain ratings', 'BTS area of hyperalgesia', 'Overall benefit', 'VAS ratings']","[{'cui': 'C0450331', 'cui_str': '17 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0205282', 'cui_str': 'Malignant (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}]","[{'cui': 'C0002771', 'cui_str': 'Analgesic Drugs'}, {'cui': 'C0231197', 'cui_str': 'Tolerance, function (observable entity)'}, {'cui': 'C0242402', 'cui_str': 'Opioids'}, {'cui': 'C0023586', 'cui_str': 'Levorphanol'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0020429', 'cui_str': 'Hyperalgesic Sensations'}]","[{'cui': 'C0231197', 'cui_str': 'Tolerance, function (observable entity)'}, {'cui': 'C0020429', 'cui_str': 'Hyperalgesic Sensations'}, {'cui': 'C0150055', 'cui_str': 'Chronic pain (finding)'}, {'cui': 'C2732532', 'cui_str': 'Brief pain inventory score'}, {'cui': 'C1123023', 'cui_str': 'Skin'}, {'cui': 'C0018851', 'cui_str': 'Heating'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",30.0,0.44153,"After observed dosing, the BTS area of hyperalgesia changed minimally but the painfulness of skin heating was reduced.","[{'ForeName': 'Michael C', 'Initials': 'MC', 'LastName': 'Rowbotham', 'Affiliation': 'CPMC Research Institute, San Francisco, California; UCSF Pain Clinical Research Center, Departments of Neurology and Anesthesia, University of California San Francisco, San Francisco, California. Electronic address: mcrowbotham@gmail.com.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Wallace', 'Affiliation': 'Division of Pain Medicine, Department of Anesthesiology, University of California San Diego, San Diego, California.'}]",The journal of pain : official journal of the American Pain Society,['10.1016/j.jpain.2020.01.005'] 3190,31998859,Agricultural and Finance Intervention Increased Dietary Intake and Weight of Children Living in HIV-Affected Households in Western Kenya.,"We tested whether a multisectoral household agricultural and finance intervention increased the dietary intake and improved the nutritional status of HIV-affected children. Two hospitals in rural Kenya were randomly assigned to be either the intervention or the control arm. The intervention comprised a human-powered water pump, microfinance loan for farm commodities, and training in sustainable farming practices and financial management. In each arm, 100 children (0-59 mo of age) were enrolled from households with HIV-infected adults 18-49 y old. Children were assessed beginning in April 2012 and every 3 mo for 1 y for dietary intake and anthropometry. Children in the intervention arm had a larger increase in weight (β: 0.025 kg/mo, P  = 0.030), overall frequency of food consumption (β: 0.610 times · wk -1 · mo -1 , P  = 0.048), and intakes of staples (β: 0.222, P  = 0.024), fruits and vegetables (β: 0.425, P  = 0.005), meat (β: 0.074, P  < 0.001), and fat (β: 0.057, P  = 0.041). Livelihood interventions have potential to improve the nutrition of HIV-affected children. This trial was registered at clinicaltrials.gov as NCT01548599.",2020,"Children in the intervention arm had a larger increase in weight (β: 0.025 kg/mo, P  = 0.030), overall frequency of food consumption (β: 0.610 times · wk -1 · mo -1 , P  = 0.048), and intakes of staples (β: 0.222, P  = 0.024), fruits and vegetables (β: 0.425, P  = 0.005), meat (β: 0.074, P  < 0.001), and fat (β: 0.057, P  = 0.041).","['100 children (0-59 mo of age) were enrolled from households with HIV-infected adults 18-49 y old', 'Two hospitals in rural Kenya', 'Children Living in HIV-Affected Households in Western Kenya']","['Agricultural and Finance Intervention', 'Livelihood interventions', 'human-powered water pump, microfinance loan for farm commodities, and training in sustainable farming practices and financial management', 'multisectoral household agricultural and finance intervention']","['overall frequency of food consumption', 'weight', 'Dietary Intake and Weight']","[{'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0022558', 'cui_str': 'Republic of Kenya'}, {'cui': 'C0392760', 'cui_str': 'Affecting (qualifier value)'}]","[{'cui': 'C0376243', 'cui_str': 'finances'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C0182537', 'cui_str': 'Pump'}, {'cui': 'C0557759', 'cui_str': 'Farmland'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0220830', 'cui_str': 'financial management'}, {'cui': 'C0020052', 'cui_str': 'Households'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}]",,0.0545619,"Children in the intervention arm had a larger increase in weight (β: 0.025 kg/mo, P  = 0.030), overall frequency of food consumption (β: 0.610 times · wk -1 · mo -1 , P  = 0.048), and intakes of staples (β: 0.222, P  = 0.024), fruits and vegetables (β: 0.425, P  = 0.005), meat (β: 0.074, P  < 0.001), and fat (β: 0.057, P  = 0.041).","[{'ForeName': 'Lisa M', 'Initials': 'LM', 'LastName': 'Butler', 'Affiliation': 'Institute for Collaboration on Health, Intervention and Policy, University of Connecticut, Storrs, CT, USA.'}, {'ForeName': 'Shiva', 'Initials': 'S', 'LastName': 'Bhandari', 'Affiliation': 'Health Promotion, Education, and Behavior, University of South Carolina, Columbia, SC, USA.'}, {'ForeName': 'Phelgona', 'Initials': 'P', 'LastName': 'Otieno', 'Affiliation': 'Kenya Medical Research Institute, Nairobi, Kenya.'}, {'ForeName': 'Sheri D', 'Initials': 'SD', 'LastName': 'Weiser', 'Affiliation': 'Department of Medicine, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Craig R', 'Initials': 'CR', 'LastName': 'Cohen', 'Affiliation': 'Department of Obstetrics, Gynecology & Reproductive Sciences, University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Edward A', 'Initials': 'EA', 'LastName': 'Frongillo', 'Affiliation': 'Health Promotion, Education, and Behavior, University of South Carolina, Columbia, SC, USA.'}]",Current developments in nutrition,['10.1093/cdn/nzaa003'] 3191,32000474,Psychology versus medication for preanesthesia preparation of children: a randomized controlled trial.,"BACKGROUND Reducing preoperative anxiety is important as inadequate preoperative management can potentially give rise to behavioral problems in the postoperative course, leading to incalculable quantitative and qualitative handicaps later in life. We compared preanesthetic administration of midazolam to a psychological strategy of walking the children through the operating room and playfully demonstrating anesthesia equipment. METHODS Of 60 children initially randomized, 43 were ultimately evaluated along with their parents. Anxiety was assessed over defined times (T1-T5) using psychometric instruments. RESULTS Primary outcome parameter: change in mean visual analogue scales (VAS) score before anesthesia (T1) to immediately before its induction (T3) in the pediatric patients. This change was significantly different (P=0.045) with a higher decrease of anxiety in the psychology group (mean - 0.13, 95% confidence interval -2.82 to -0.075) compared to the medication group (mean 1.39, 95% confidence interval 0.12 to 3.01). Secondary outcome parameters, State-Trait Anxiety Inventory (STAI): despite no significant intergroup difference in trait anxiety, state anxiety increased significantly in the medication but not in the psychology group (both true of children and parents). Modified Yale Preoperative Anxiety Scale (m-YPAS): the only significant decreases in parameters (for vocalization and emotional expressivity) were seen in the psychology group, and all parameters confirmed the finding of significantly greater anxiety in the medication group than in the psychology group at T3. CONCLUSIONS All psychometric instruments used in this study indicated that our psychological strategy of preanesthesia preparation was capable of successfully reducing anxiety in paediatric patients and their parents.",2020,"This change was significantly different (p = 0.045) with a higher decrease of anxiety in the psychology group (mean 0.13, 95% confidence interval 2.82 to 0.075) compared to the medication group","['children', '60 children initially randomized, 43 were ultimately evaluated along with their parents', 'paediatric patients and their parents']","['midazolam', 'Psychology versus medication']","['Anxiety', 'StateTrait Anxiety Inventory (STAI', 'Modified Yale Preoperative Anxiety Scale (mYPAS', 'mean visual analogue scales (VAS) score before anaesthesia (T1', 'parameters (for vocalization and emotional expressivity', 'anxiety', 'trait anxiety, state anxiety']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0026056', 'cui_str': 'Midazolam'}, {'cui': 'C0033909', 'cui_str': 'Psychology'}]","[{'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0021941', 'cui_str': 'Inventories'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0002903', 'cui_str': 'Anesthesia'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0564182', 'cui_str': 'Vocalizing'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C1301808', 'cui_str': 'State'}]",60.0,0.0472645,"This change was significantly different (p = 0.045) with a higher decrease of anxiety in the psychology group (mean 0.13, 95% confidence interval 2.82 to 0.075) compared to the medication group","[{'ForeName': 'Werner', 'Initials': 'W', 'LastName': 'Schmid', 'Affiliation': 'Department of Anesthesia Intensive Care Medicine and Pain Medicine, Medical University of Vienna, Vienna, Austria - werner.schmid@meduniwien.ac.at.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Marhofer', 'Affiliation': 'Department of Anesthesia Intensive Care Medicine and Pain Medicine, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'Ohmann', 'Affiliation': 'Department of Child and Adolescent Psychiatry, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Oliver', 'Initials': 'O', 'LastName': 'Kimberger', 'Affiliation': 'Department of Anesthesia Intensive Care Medicine and Pain Medicine, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Daniela', 'Initials': 'D', 'LastName': 'Marhofer', 'Affiliation': 'Department of Anesthesia Intensive Care Medicine and Pain Medicine, Medical University of Vienna, Vienna, Austria.'}, {'ForeName': 'Lydia', 'Initials': 'L', 'LastName': 'Triffterer', 'Affiliation': 'Department of Anesthesia Intensive Care Medicine and Pain Medicine, Medical University of Vienna, Vienna, Austria.'}]",Minerva anestesiologica,['10.23736/S0375-9393.20.14082-3'] 3192,32005308,Risk of hearing loss among multidrug-resistant tuberculosis patients according to cumulative aminoglycoside dose.,"SETTING: The ototoxic effects of aminoglycosides (AGs) lead to permanent hearing loss, which is one of the devastating consequences of multidrug-resistant tuberculosis (MDR-TB) treatment. As AG ototoxicity is dose-dependent, the impact of a surrogate measure of AG exposure on AG-induced hearing loss warrants close attention for settings with limited therapeutic drug monitoring. OBJECTIVE: To explore the prognostic impact of cumulative AG dose on AG ototoxicity in patients following initiation of AG-containing treatment for MDR-TB. DESIGN: This prospective cohort study was nested within an ongoing cluster-randomized trial of nurse case management intervention across 10 MDR-TB hospitals in South Africa. RESULTS: The adjusted hazard of AG regimen modification due to ototoxicity in the high-dose group (≥75 mg/kg/week) was 1.33 times higher than in the low-dose group (<75 mg/kg/week, 95%CI 1.09-1.64). The adjusted hazard of developing audiometric hearing loss was 1.34 times higher than in the low-dose group (95%CI 1.01-1.77). Pre-existing hearing loss (adjusted hazard ratio [aHR] 1.71, 95%CI 1.29-2.26) and age (aHR 1.16 per 10 years of age, 95%CI 1.01-1.33) were also associated with an increased risk of hearing loss. CONCLUSION: MDR-TB patients with high AG dose, advanced age and pre-existing hearing loss have a significantly higher risk of AG-induced hearing loss. Those at high risk may be candidates for more frequent monitoring or AG-sparing regimens.",2020,The adjusted hazard of developing audiometric hearing loss was 1.34 times higher than in the low-dose group (95%CI 1.01-1.77).,"['multidrug-resistant tuberculosis patients', 'patients following initiation of AG-containing treatment for MDR-TB', 'across 10 MDR-TB hospitals in South Africa']","['nurse case management intervention', 'aminoglycosides (AGs']","['ototoxicity', 'adjusted hazard of developing audiometric hearing loss', 'Pre-existing hearing loss', 'hearing loss', 'risk of hearing loss']","[{'cui': 'C0206526', 'cui_str': 'Tuberculosis, Multi-Drug Resistant'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation (observable entity)'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0037712', 'cui_str': 'Union of South Africa'}]","[{'cui': 'C0028661', 'cui_str': 'Personnel, Nursing'}, {'cui': 'C0085971', 'cui_str': 'Case Management'}, {'cui': 'C0002556', 'cui_str': 'Aminoglycosides'}]","[{'cui': 'C0235280', 'cui_str': 'Ototoxicity (disorder)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C1384666', 'cui_str': 'Hypoacusis'}, {'cui': 'C0035647', 'cui_str': 'Risk'}]",,0.0781323,The adjusted hazard of developing audiometric hearing loss was 1.34 times higher than in the low-dose group (95%CI 1.01-1.77).,"[{'ForeName': 'H', 'Initials': 'H', 'LastName': 'Hong', 'Affiliation': 'Johns Hopkins University School of Nursing, Baltimore, MD, The REACH Initiative, Johns Hopkins University School of Nursing, Baltimore, MD.'}, {'ForeName': 'D W', 'Initials': 'DW', 'LastName': 'Dowdy', 'Affiliation': 'Departments of Epidemiology and International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD.'}, {'ForeName': 'K E', 'Initials': 'KE', 'LastName': 'Dooley', 'Affiliation': 'Divisions of Clinical Pharmacology and Infectious Disease, Johns Hopkins University School of Medicine, Baltimore, MD.'}, {'ForeName': 'H W', 'Initials': 'HW', 'LastName': 'Francis', 'Affiliation': 'Division of Head and Neck Surgery and Communication Sciences, Duke University School of Medicine, Durham, NC.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Budhathoki', 'Affiliation': 'Johns Hopkins University School of Nursing, Baltimore, MD.'}, {'ForeName': 'H-R', 'Initials': 'HR', 'LastName': 'Han', 'Affiliation': 'Johns Hopkins University School of Nursing, Baltimore, MD, Center for Cardiovascular and Chronic Care, Johns Hopkins University, Baltimore, MD, USA.'}, {'ForeName': 'J E', 'Initials': 'JE', 'LastName': 'Farley', 'Affiliation': 'Johns Hopkins University School of Nursing, Baltimore, MD, The REACH Initiative, Johns Hopkins University School of Nursing, Baltimore, MD.'}]",The international journal of tuberculosis and lung disease : the official journal of the International Union against Tuberculosis and Lung Disease,['10.5588/ijtld.19.0062'] 3193,32003647,Eccentric and Isometric Exercises in Achilles Tendinopathy Evaluated by the VISA-A Score and Shear Wave Elastography.,"BACKGROUND Apart from eccentric exercises (EE), isometric exercises (ISO) might be a treatment option for Achilles tendinopathy. Shear wave elastography (SWE) provides information for diagnosis and for monitoring tissue elasticity, which is altered in symptomatic tendons. HYPOTHESIS Isometric exercises will have a beneficial effect on patients' outcome scores. Based on SWE, insertional and midportion tendon parts will differ in their elastic properties according to current symptoms. STUDY DESIGN Randomized clinical trial. LEVEL OF EVIDENCE Level 2. METHODS Group 1 (EE; n = 20; 12 males, 8 females; mean age, 52 ± 8.98 years) and group 2 (EE + ISO; n = 22; 15 males, 7 females; mean age, 47 ± 15.11 years) performed exercises for 3 months. Measurement points were before exercises were initiated as well as after 1 and 3 months using the Victorian Institute of Sports Assessment-Achilles (VISA-A) score, American Orthopaedic Foot & Ankle Society score, and SWE (insertion and midportion). RESULTS Both groups improved significantly, but there were no significant interindividual differences (VISA-A; P = 0.362) between group 1 (n = 15; +15 VISA-A) and group 2 (n = 15; +15 VISA-A). The symptomatic insertion (symptomatic, 136.89 kPa; asymptomatic, 174.68 kPa; P = 0.045) and the symptomatic midportion of the Achilles tendon (symptomatic, 184.40 kPa; asymptomatic, 215.41 kPa; P = 0.039) had significantly lower Young modulus compared with the asymptomatic tendons. The midportion location had significantly higher Young modulus than the insertional part of the tendon ( P = 0.005). CONCLUSION Isometric exercises do not have additional benefit when combined with eccentric exercises, as assessed over a 3-month intervention period. SWE is able to distinguish between insertional and midportion tendon parts in a symptomatic and asymptomatic state. CLINICAL RELEVANCE The present study shows no additional effect of ISO when added to baseline EE in treating Achilles tendinopathy. Different elastic properties of the insertional and midportion tendon have to be taken into consideration when rating a tendon as pathologic.",2020,"The symptomatic insertion (symptomatic, 136.89 kPa; asymptomatic, 174.68 kPa; P = 0.045) and the symptomatic midportion of the Achilles tendon (symptomatic, 184.40 kPa; asymptomatic, 215.41 kPa; P = 0.039) had significantly lower Young modulus compared with the asymptomatic tendons.","['Group 1 (EE; n = 20; 12 males, 8 females; mean age, 52 ± 8.98 years) and group 2 (EE + ISO; n = 22; 15 males, 7 females; mean age, 47 ± 15.11 years', 'Achilles']","['SWE', 'Shear wave elastography (SWE', 'Victorian Institute of Sports Assessment-Achilles', 'Eccentric and Isometric Exercises', 'Isometric exercises', 'ISO', 'eccentric exercises (EE), isometric exercises (ISO']","['symptomatic midportion of the Achilles tendon', 'VISA-A Score and Shear Wave Elastography', 'VISA-A) score, American Orthopaedic Foot & Ankle Society score, and SWE (insertion and midportion']","[{'cui': 'C0441861', 'cui_str': 'Group 1 (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0441865', 'cui_str': 'Group 2 (qualifier value)'}, {'cui': 'C0911936', 'cui_str': 'iso(VL)'}]","[{'cui': 'C1955928', 'cui_str': 'Elastography'}, {'cui': 'C0021622', 'cui_str': 'Institutes'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0439740', 'cui_str': 'Eccentric (qualifier value)'}, {'cui': 'C0022206', 'cui_str': 'Exercise, Isometric'}, {'cui': 'C0911936', 'cui_str': 'iso(VL)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}]","[{'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0001074', 'cui_str': 'Calcaneal Tendon'}, {'cui': 'C1318881', 'cui_str': 'Infection due to vancomycin intermediate Staphylococcus aureus'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C1955928', 'cui_str': 'Elastography'}, {'cui': 'C0016504', 'cui_str': 'Foot'}, {'cui': 'C0003086', 'cui_str': 'Regio tarsalis'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0441587', 'cui_str': 'Insertion - action'}]",,0.0372102,"The symptomatic insertion (symptomatic, 136.89 kPa; asymptomatic, 174.68 kPa; P = 0.045) and the symptomatic midportion of the Achilles tendon (symptomatic, 184.40 kPa; asymptomatic, 215.41 kPa; P = 0.039) had significantly lower Young modulus compared with the asymptomatic tendons.","[{'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Gatz', 'Affiliation': 'Department of Orthopedics, University Hospital RWTH Aachen, Aachen, Germany.'}, {'ForeName': 'Marcel', 'Initials': 'M', 'LastName': 'Betsch', 'Affiliation': 'Department of Orthopedics, University Hospital RWTH Aachen, Aachen, Germany.'}, {'ForeName': 'Timm', 'Initials': 'T', 'LastName': 'Dirrichs', 'Affiliation': 'Department of Diagnostic and Interventional Radiology, University Hospital RWTH Aachen, Aachen, Germany.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Schrading', 'Affiliation': 'Department of Diagnostic and Interventional Radiology, University Hospital RWTH Aachen, Aachen, Germany.'}, {'ForeName': 'Markus', 'Initials': 'M', 'LastName': 'Tingart', 'Affiliation': 'Department of Orthopedics, University Hospital RWTH Aachen, Aachen, Germany.'}, {'ForeName': 'Roman', 'Initials': 'R', 'LastName': 'Michalik', 'Affiliation': 'Department of Orthopedics, University Hospital RWTH Aachen, Aachen, Germany.'}, {'ForeName': 'Valentin', 'Initials': 'V', 'LastName': 'Quack', 'Affiliation': 'Department of Orthopedics, University Hospital RWTH Aachen, Aachen, Germany.'}]",Sports health,['10.1177/1941738119893996'] 3194,31812464,"A Phase 2/3 double blinded, randomized, placebo-controlled study in healthy adult participants in Vietnam to examine the safety and immunogenicity of an inactivated whole virion, alum adjuvanted, A(H5N1) influenza vaccine (IVACFLU-A/H5N1).","BACKGROUND A global shortfall of vaccines for avian influenza A(H5N1) would occur, especially in low- and-middle income countries, if a pandemic were to occur. To address this issue, development of a pre-pandemic influenza vaccine was initiated in 2012, leveraging a recently established influenza vaccine manufacturing capacity in Vietnam. METHODS This was a Phase 2/3, double-blinded, randomized, placebo-controlled study to test the safety and immunogenicity of IVACFLU-A/H5N1 vaccine in healthy adults. Phase 2 was a dose selection study, in which 300 participants were randomized to one of the three groups (15 mcg, 30 mcg, or placebo). Safety and immunogenicity were assessed in all participants. In Phase 3, 630 participants were randomized to receive the IVACFLU-A/H5N1 vaccine dose selected in Phase 2 (15 mcg, n = 525) or placebo (n = 105). Safety was assessed in all Phase 3 participants and immunogenicity was measured in a subset of participants. RESULTS The vaccine was well tolerated and most of the adverse events were mild and of short duration. Mild pain at the injection site was the most common adverse event seen in 60 percent of participants in the vaccine group in Phase 3. In Phase 2, both 15 mcg and 30 mcg doses were immunogenic, so the lower dose was selected for further testing in Phase 3. In Phase 3 overall seroconversion rates were 68 percent for hemagglutination inhibition (HI), 51 percent for microneutralization (MN) and 56 percent for single radial hemolysis (SRH). The seroprotection rates were 44 percent for HI, 41 percent for MN and 55 percent for SRH. The GMT ratio was 5.31 and 3.7 for HI and MN respectively; GMA was 4.75 for the SRH. CONCLUSION The IVACFLU A/H5N1 was safe and immunogenic. Development of this pandemic avian influenza vaccine is a welcome addition to the limited global pool of these vaccines. ClinicalTrials.gov register NCT02612909.",2020,"In Phase 3 overall seroconversion rates were 68 percent for hemagglutination inhibition (HI), 51 percent for microneutralization (MN) and 56 percent for single radial hemolysis (SRH).","['healthy adults', '2012, leveraging a recently established influenza vaccine manufacturing capacity in Vietnam', '630 participants', 'healthy adult participants in Vietnam', '300 participants']","['IVACFLU', 'placebo', 'IVACFLU-A/H5N1 vaccine', 'inactivated whole virion, alum adjuvanted, A(H5N1) influenza vaccine (IVACFLU-A/H5N1']","['overall seroconversion rates', 'seroprotection rates', 'Safety and immunogenicity', 'GMT ratio', 'Mild pain', 'Safety']","[{'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0332185', 'cui_str': 'Recent episode (qualifier value)'}, {'cui': 'C0443211', 'cui_str': 'Established (qualifier value)'}, {'cui': 'C0021403', 'cui_str': 'Influenza Vaccines'}, {'cui': 'C0042658', 'cui_str': 'Viet Nam'}, {'cui': 'C4708165', 'cui_str': 'Six hundred and thirty'}, {'cui': 'C4319604', 'cui_str': '300'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0042760', 'cui_str': 'Viral Particles'}, {'cui': 'C0137988', 'cui_str': 'alum'}, {'cui': 'C0021403', 'cui_str': 'Influenza Vaccines'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C4042908', 'cui_str': 'Seroconversion'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0278138', 'cui_str': 'Mild pain (finding)'}]",300.0,0.538309,"In Phase 3 overall seroconversion rates were 68 percent for hemagglutination inhibition (HI), 51 percent for microneutralization (MN) and 56 percent for single radial hemolysis (SRH).","[{'ForeName': 'Tran Nhu', 'Initials': 'TN', 'LastName': 'Duong', 'Affiliation': 'National Institute of Hygiene and Epidemiology, Hanoi, Viet Nam.'}, {'ForeName': 'Vu Dinh', 'Initials': 'VD', 'LastName': 'Thiem', 'Affiliation': 'National Institute of Hygiene and Epidemiology, Hanoi, Viet Nam.'}, {'ForeName': 'Dang Duc', 'Initials': 'DD', 'LastName': 'Anh', 'Affiliation': 'National Institute of Hygiene and Epidemiology, Hanoi, Viet Nam.'}, {'ForeName': 'Nguyen Phu', 'Initials': 'NP', 'LastName': 'Cuong', 'Affiliation': 'PATH, Hanoi, Viet Nam.'}, {'ForeName': 'Tran Cong', 'Initials': 'TC', 'LastName': 'Thang', 'Affiliation': 'PATH, Hanoi, Viet Nam.'}, {'ForeName': 'Vu Minh', 'Initials': 'VM', 'LastName': 'Huong', 'Affiliation': 'PATH, Hanoi, Viet Nam.'}, {'ForeName': 'Vien Chinh', 'Initials': 'VC', 'LastName': 'Chien', 'Affiliation': 'Institute of Vaccines and Medical Biologicals, Nha Trang, Viet Nam.'}, {'ForeName': 'Nguyen Thi Lan', 'Initials': 'NTL', 'LastName': 'Phuong', 'Affiliation': 'Institute of Vaccines and Medical Biologicals, Nha Trang, Viet Nam.'}, {'ForeName': 'Emanuele', 'Initials': 'E', 'LastName': 'Montomoli', 'Affiliation': 'Department of Molecular and Developmental Medicine, University of Siena, Siena, Italy; VisMederi srl, Siena, Italy.'}, {'ForeName': 'Renee', 'Initials': 'R', 'LastName': 'Holt', 'Affiliation': 'PATH, Seattle, USA.'}, {'ForeName': 'Francesco Berlanda', 'Initials': 'FB', 'LastName': 'Scorza', 'Affiliation': 'PATH, Seattle, USA.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Flores', 'Affiliation': 'PATH, Seattle, USA.'}, {'ForeName': 'Tushar', 'Initials': 'T', 'LastName': 'Tewari', 'Affiliation': 'PATH, Seattle, USA. Electronic address: ttewari@path.org.'}]",Vaccine,['10.1016/j.vaccine.2019.11.059'] 3195,31836545,Beyond the bladder: poor sleep in women with overactive bladder syndrome.,"BACKGROUND Nocturnal bladder symptoms and sleep disruption commonly coexist in middle-aged and older women. Although sleep disruption is often attributed to nocturnal bladder symptoms in women with overactive bladder syndrome, nonbladder factors also may influence sleep in this population. Many women with overactive bladder are eager to identify nonpharmacologic strategies for both bladder symptoms and sleep disruption, given the potential adverse effects of sedative and anticholinergic bladder medications in this population. OBJECTIVES To provide greater insight into the complex relationship between nighttime overactive bladder symptoms and sleep disruption, and to evaluate the effects of a guided slow-paced respiration intervention on sleep outcomes in women with overactive bladder. STUDY DESIGN We conducted an ancillary study within a randomized trial of slow-paced respiration in women with overactive bladder symptoms. Ambulatory community-dwelling women who reported ≥3 episodes/day of urgency-associated voiding or incontinence were randomized to use either a portable biofeedback device (RESPeRATE; Intercure, Ltd) to practice guided slow-paced respiration exercises daily for 12 weeks (N=79) or an identical-appearing device programmed to play nonrhythmic music without guiding breathing (N=82). At baseline and after 12 weeks, bladder symptoms were assessed by voiding diary, sleep duration, and disruption were assessed by sleep diary corroborated by wrist actigraphy, and poor sleep quality was determined by a Pittsburgh Sleep Quality Index global score >5. RESULTS Of the 161 women randomized, 31% reported at least twice-nightly nocturia, 26% nocturnal incontinence, and 70% poor sleep quality at baseline. Of the 123 reporting any nighttime awakenings, 89% averaged 1 or more nighttime awakenings, and 83% attributed at least half of awakenings to using the bathroom. Self-reported wake time after sleep onset increased with increasing frequency of nocturnal bladder symptoms (P=.01 for linear trend). However, even among women without nocturia, average sleep quality was poor (Pittsburg Sleep Quality Index global score mean of 7.3; 95% confidence interval, 6.0-8.6). Over 12 weeks, women assigned to slow-paced respiration (N=79) experienced modest improvements in mean nocturnal voiding frequency (0.4 fewer voids/night), sleep quality (1.1 point score decrease), and sleep disruption (1.5% decreased wake time after sleep onset). However, similar improvements were detected in the music control group (N=81), without significant between-group differences. CONCLUSIONS Many women with overactive bladder syndrome experience disrupted sleep, but not all nocturnal awakenings are attributable to bladder symptoms, and average sleep quality tends to be poor even in women without nocturia. Findings suggest that clinicians should not assume that poor sleep in women with overactive bladder syndrome is primarily caused by nocturnal bladder symptoms. Guided slow-paced respiration was associated with modest improvements in nocturia frequency and sleep quality in this trial, but the results do not support clinician recommendation to use this technique over other behavioral relaxation techniques for improving sleep.",2020,"However, similar improvements were detected in the music control group (N=81), without significant between-group differences. ","['women with overactive bladder', 'middle-aged and older women', 'Ambulatory community-dwelling women who reported ≥3 episodes/day of urgency-associated voiding or incontinence', 'women with overactive bladder syndrome', '161 women randomized', 'women with overactive bladder symptoms']","['slow-paced respiration', 'Guided slow-paced respiration', 'portable biofeedback device (RESPeRATE; Intercure, Ltd) to practice guided slow-paced respiration exercises daily for 12 weeks (N=79) or an identical-appearing device programmed to play nonrhythmic music without guiding breathing', 'guided slow-paced respiration intervention']","['mean nocturnal voiding frequency', 'sleep outcomes', 'average sleep quality', 'nighttime awakenings', 'bladder symptoms', 'nocturia frequency and sleep quality', 'sleep quality', 'nocturnal bladder symptoms', 'voiding diary, sleep duration, and disruption were assessed by sleep diary corroborated by wrist actigraphy, and poor sleep quality', 'Pittsburgh Sleep Quality Index global score >5', 'sleep disruption']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0878773', 'cui_str': 'Overactive Bladder'}, {'cui': 'C0205847', 'cui_str': 'Middle Aged'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0439841', 'cui_str': 'Ambulatory'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0439609', 'cui_str': 'Urgency (qualifier value)'}, {'cui': 'C0021167', 'cui_str': 'Incontinence (finding)'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]","[{'cui': 'C0439834', 'cui_str': 'Slowly'}, {'cui': 'C0035203', 'cui_str': 'Breathing'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0678663', 'cui_str': 'Biofeedback, function (observable entity)'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0205280', 'cui_str': 'Identical (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0032214', 'cui_str': 'Play'}, {'cui': 'C0026867', 'cui_str': 'Music'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0240526', 'cui_str': 'Night time (qualifier value)'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C1720052', 'cui_str': 'Awakening'}, {'cui': 'C0005682', 'cui_str': 'Bladder'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0028734', 'cui_str': 'Nycturia'}, {'cui': 'C0376660', 'cui_str': 'Diary'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0332453', 'cui_str': 'Disruption (morphologic abnormality)'}, {'cui': 'C0043262', 'cui_str': 'Wrist'}, {'cui': 'C1171301', 'cui_str': 'Actigraphy'}, {'cui': 'C0235162', 'cui_str': 'Difficulty sleeping (finding)'}, {'cui': 'C3697468', 'cui_str': 'PSQI - Pittsburgh sleep quality index'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439084', 'cui_str': '>5 (qualifier value)'}]",161.0,0.110217,"However, similar improvements were detected in the music control group (N=81), without significant between-group differences. ","[{'ForeName': 'Marissa B', 'Initials': 'MB', 'LastName': 'Savoie', 'Affiliation': 'School of Medicine, University of California San Francisco, CA. Electronic address: marissa.savoie@ucsf.edu.'}, {'ForeName': 'Kathryn A', 'Initials': 'KA', 'LastName': 'Lee', 'Affiliation': 'Department of Family Health Care Nursing, University of California San Francisco, CA.'}, {'ForeName': 'Leslee L', 'Initials': 'LL', 'LastName': 'Subak', 'Affiliation': 'Department of Obstetrics and Gynecology, Stanford University, Stanford, CA.'}, {'ForeName': 'Cesar', 'Initials': 'C', 'LastName': 'Hernandez', 'Affiliation': 'Department of Medicine, University of California San Francisco, CA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Schembri', 'Affiliation': 'Department of Obstetrics, Gynecology, & Reproductive Sciences, University of California San Francisco, CA.'}, {'ForeName': 'Constance H', 'Initials': 'CH', 'LastName': 'Fung', 'Affiliation': 'Department of Medicine, University of California at Los Angeles, CA; VA Greater Los Angeles Healthcare System, Los Angeles, CA.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Grady', 'Affiliation': 'Department of Medicine, University of California San Francisco, CA.'}, {'ForeName': 'Alison J', 'Initials': 'AJ', 'LastName': 'Huang', 'Affiliation': 'Department of Medicine, University of California San Francisco, CA.'}]",American journal of obstetrics and gynecology,['10.1016/j.ajog.2019.12.005'] 3196,31843270,"Safety and immunogenicity of a 30-valent M protein-based group a streptococcal vaccine in healthy adult volunteers: A randomized, controlled phase I study.","BACKGROUND Streptococcus pyogenes (group A Streptococcus, Strep A) is a widespread pathogen that continues to pose a significant threat to human health. The development of a Strep A vaccine remains an unmet global health need. One of the major vaccine strategies is the use of M protein, which is a primary virulence determinant and protective antigen. Multivalent recombinant M protein vaccines are being developed with N-terminal M peptides that contain opsonic epitopes but do not contain human tissue cross-reactive epitopes. METHODS We completed a Phase I trial of a recombinant 30-valent M protein-based Strep A vaccine (Strep A vaccine, StreptAnova™) comprised of four recombinant proteins containing N-terminal peptides from 30 M proteins of common pharyngitis and invasive and/or rheumatogenic serotypes, adjuvanted with aluminum hydroxide. The trial was observer-blinded and randomized in a 2:1 ratio for intramuscular administration of Strep A vaccine or an alum-based comparator in healthy adult volunteers, at 0, 30 and 180 days. Primary outcome measures were assessments of safety, including assays for antibodies that cross-reacted with host tissues, and immunogenicity assessed by ELISA with the individual vaccine peptides and by opsonophagocytic killing (OPK) assays in human blood. RESULTS Twenty-three Strep A-vaccinated participants and 13 controls completed the study. The Strep A vaccine was well-tolerated and there was no clinical evidence of autoimmunity and no laboratory evidence of tissue cross-reactive antibodies. The vaccine was immunogenic and elicited significant increases in geometric mean antibody levels to 24 of the 30 component M antigens by ELISA. Vaccine-induced OPK activity was observed against selected M types of Strep A in vaccinated participants that seroconverted to specific M peptides. CONCLUSION The Strep A vaccine was well tolerated and immunogenic in healthy adults, providing strong support for further clinical development. [ClinicalTrials.gov NCT02564237].",2020,The vaccine was immunogenic and elicited significant increases in geometric mean antibody levels to 24 of the 30 component M antigens by ELISA.,"['healthy adults', 'healthy adult volunteers, at 0, 30 and 180\xa0days', 'healthy adult volunteers', 'Twenty-three Strep A-vaccinated participants and 13 controls completed the study']","['recombinant 30-valent M protein-based Strep A vaccine (Strep A vaccine, StreptAnova™) comprised of four recombinant proteins containing N-terminal peptides', 'Strep A vaccine', '30-valent M protein-based group a streptococcal vaccine', 'aluminum hydroxide', 'Multivalent recombinant M protein vaccines']","['Safety and immunogenicity', 'safety, including assays for antibodies that cross-reacted with host tissues, and immunogenicity assessed by ELISA with the individual vaccine peptides and by opsonophagocytic killing (OPK) assays in human blood', 'geometric mean antibody levels', 'tolerated and immunogenic', 'OPK activity']","[{'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C4319557', 'cui_str': '180'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0450348', 'cui_str': '23 (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0065450', 'cui_str': 'M-proteins (Myeloma)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0034861', 'cui_str': 'Biosynthetic Proteins'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0030956', 'cui_str': 'Peptides'}, {'cui': 'C0441835', 'cui_str': 'Group A (qualifier value)'}, {'cui': 'C0887906', 'cui_str': 'Streptococcal Vaccines'}, {'cui': 'C0002371', 'cui_str': 'aluminium hydroxide'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1510438', 'cui_str': 'Assay technique (qualifier value)'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C0205203', 'cui_str': 'Crossed (qualifier value)'}, {'cui': 'C4224854', 'cui_str': 'React'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C0014441', 'cui_str': 'ELISA'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0030956', 'cui_str': 'Peptides'}, {'cui': 'C0162388', 'cui_str': 'Killing'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0005768'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}]",,0.207819,The vaccine was immunogenic and elicited significant increases in geometric mean antibody levels to 24 of the 30 component M antigens by ELISA.,"[{'ForeName': 'Élodie', 'Initials': 'É', 'LastName': 'Pastural', 'Affiliation': 'Pan-Provincial Vaccine Enterprise Inc. (PREVENT), Saskatoon, Saskatchewan, Canada.'}, {'ForeName': 'Shelly A', 'Initials': 'SA', 'LastName': 'McNeil', 'Affiliation': 'Canadian Center for Vaccinology, Dalhousie University, IWK Health Centre, Nova Scotia Health Authority, Halifax, Nova Scotia, Canada; Division of Infectious Diseases, Department of Medicine, Dalhousie University, Halifax, Nova Scotia, Canada. Electronic address: Shelly.McNeil@nshealth.ca.'}, {'ForeName': 'Donna', 'Initials': 'D', 'LastName': 'MacKinnon-Cameron', 'Affiliation': 'Canadian Center for Vaccinology, Dalhousie University, IWK Health Centre, Nova Scotia Health Authority, Halifax, Nova Scotia, Canada.'}, {'ForeName': 'Lingyun', 'Initials': 'L', 'LastName': 'Ye', 'Affiliation': 'Canadian Center for Vaccinology, Dalhousie University, IWK Health Centre, Nova Scotia Health Authority, Halifax, Nova Scotia, Canada.'}, {'ForeName': 'Joanne M', 'Initials': 'JM', 'LastName': 'Langley', 'Affiliation': 'Canadian Center for Vaccinology, Dalhousie University, IWK Health Centre, Nova Scotia Health Authority, Halifax, Nova Scotia, Canada; Division of Infectious Diseases, Department of Pediatrics, Dalhousie University, Halifax, Nova Scotia, Canada.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Stewart', 'Affiliation': 'Division of Cardiology, Department of Medicine, Dalhousie University, Halifax, Nova Scotia, Canada.'}, {'ForeName': 'Luis H', 'Initials': 'LH', 'LastName': 'Martin', 'Affiliation': 'Pan-Provincial Vaccine Enterprise Inc. (PREVENT), Saskatoon, Saskatchewan, Canada.'}, {'ForeName': 'Gregory J', 'Initials': 'GJ', 'LastName': 'Hurley', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, University of Tennessee Health Science Center, Memphis, TN, USA.'}, {'ForeName': 'Sanaz', 'Initials': 'S', 'LastName': 'Salehi', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, University of Tennessee Health Science Center, Memphis, TN, USA.'}, {'ForeName': 'Thomas A', 'Initials': 'TA', 'LastName': 'Penfound', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, University of Tennessee Health Science Center, Memphis, TN, USA.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Halperin', 'Affiliation': 'Canadian Center for Vaccinology, Dalhousie University, IWK Health Centre, Nova Scotia Health Authority, Halifax, Nova Scotia, Canada; Division of Infectious Diseases, Department of Pediatrics, Dalhousie University, Halifax, Nova Scotia, Canada.'}, {'ForeName': 'James B', 'Initials': 'JB', 'LastName': 'Dale', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, University of Tennessee Health Science Center, Memphis, TN, USA.'}]",Vaccine,['10.1016/j.vaccine.2019.12.005'] 3197,31449829,Effect of pituitary adenylate cyclase-activating polypeptide-27 on cerebral hemodynamics in healthy volunteers: A 3T MRI study.,"Pituitary adenylate cyclase-activating polypeptide (PACAP) has emerged as an important signaling peptide in migraine pathogenesis. Recently, we have shown that the less-abundant PACAP isoform, PACAP27, induced migraine and headache in patients equipotently to PACAP38. The present study examined the effect of PACAP27 on cerebral hemodynamics in healthy volunteers using high resolution magnetic resonance angiography (MRA). Eighteen healthy volunteers received infusion of PACAP27 (10 pmol/kg/min) or placebo over 20 min and were scanned repeatedly in fixed intervals for 5 h in a double-blind, randomized, placebo-controlled study. The circumference of extra-intracerebral arteries was measured and compared with PACAP38 data. We found significant dilation of middle meningeal artery (MMA) (p = 0.019), superficial temporal artery (p = 0.001) and external carotid artery (p = 0.039) after PACAP27 infusion compared to placebo. Whereas the middle cerebral artery (MCA) (p = 0.011) and internal carotid artery (ICA) (p ICAcervical  = 0.015, p ICAcerebral  = 0.019) were constricted. No effects on basilar artery (p = 0.708) and cavernous portion of ICA were found. Post hoc analyses revealed significant larger area under the curve for MMA after PACAP38 compared to PACAP27 (p = 0.033). We also found that PACAP27 induced headache in nine out of twelve (75%) volunteers and one (17%) after placebo. In conclusion, PACAP27 induced headache and dilated extracerebral arteries (>5 h) and slightly constricted MCA in healthy volunteers. Post hoc analysis of PACAP38 data compared with PACAP27 showed that PACAP isoforms dilates MMA with significantly different magnitude.",2019,No effects on basilar artery (p = 0.708) and cavernous portion of ICA were found.,"['healthy volunteers using high resolution magnetic resonance angiography (MRA', 'healthy volunteers', 'Eighteen healthy volunteers']","['PACAP27', 'placebo', 'Pituitary adenylate cyclase-activating polypeptide (PACAP', 'pituitary adenylate cyclase-activating polypeptide-27']","['circumference of extra-intracerebral arteries', 'headache', 'internal carotid artery (ICA', 'headache and dilated extracerebral arteries', 'external carotid artery', 'basilar artery', 'dilation of middle meningeal artery (MMA', 'cavernous portion of ICA', 'middle cerebral artery (MCA', 'superficial temporal artery', 'cerebral hemodynamics']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0243032', 'cui_str': 'MRI Angiography'}, {'cui': 'C3715206', 'cui_str': 'Eighteen'}]","[{'cui': 'C0084057', 'cui_str': 'PACAP27'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0001492', 'cui_str': 'Adenylate Cyclase'}, {'cui': 'C1305923', 'cui_str': 'Polypeptides'}, {'cui': 'C0071163', 'cui_str': 'PACAP'}]","[{'cui': 'C0332520', 'cui_str': 'Circumference'}, {'cui': 'C0442111', 'cui_str': 'Intracerebral (qualifier value)'}, {'cui': 'C0003842', 'cui_str': 'Arteries'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0007276', 'cui_str': 'Carotid Artery, Internal'}, {'cui': 'C0201519', 'cui_str': 'Antibody to islet cells of pancreas measurement (procedure)'}, {'cui': 'C0007275', 'cui_str': 'Carotid Artery, External'}, {'cui': 'C0004811', 'cui_str': 'Basilar Artery'}, {'cui': 'C1322279', 'cui_str': 'Dilation'}, {'cui': 'C0226147', 'cui_str': 'Structure of middle meningeal artery'}, {'cui': 'C0916871', 'cui_str': 'MMA(III)'}, {'cui': 'C0205201', 'cui_str': 'Cavernous (qualifier value)'}, {'cui': 'C0149566', 'cui_str': 'Middle Cerebral Artery'}, {'cui': 'C0226130', 'cui_str': 'Structure of superficial temporal artery'}]",18.0,0.147486,No effects on basilar artery (p = 0.708) and cavernous portion of ICA were found.,"[{'ForeName': 'Hashmat', 'Initials': 'H', 'LastName': 'Ghanizada', 'Affiliation': 'Danish Headache Center and Department of Neurology, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Denmark.'}, {'ForeName': 'Mohammad Al-Mahdi', 'Initials': 'MA', 'LastName': 'Al-Karagholi', 'Affiliation': 'Danish Headache Center and Department of Neurology, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Denmark.'}, {'ForeName': 'Nanna', 'Initials': 'N', 'LastName': 'Arngrim', 'Affiliation': 'Danish Headache Center and Department of Neurology, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Denmark.'}, {'ForeName': 'Mustafa', 'Initials': 'M', 'LastName': 'Ghanizada', 'Affiliation': 'Danish Headache Center and Department of Neurology, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Denmark.'}, {'ForeName': 'Henrik Bo Wiberg', 'Initials': 'HBW', 'LastName': 'Larsson', 'Affiliation': 'Functional Imaging Unit, Department of Clinical Physiology, Nuclear Medicine and PET, Rigshospitalet, Faculty of Health and Medical Sciences, University of Copenhagen, Denmark.'}, {'ForeName': 'Faisal Mohammad', 'Initials': 'FM', 'LastName': 'Amin', 'Affiliation': 'Danish Headache Center and Department of Neurology, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Denmark.'}, {'ForeName': 'Messoud', 'Initials': 'M', 'LastName': 'Ashina', 'Affiliation': 'Danish Headache Center and Department of Neurology, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Denmark. Electronic address: ashina@dadlnet.dk.'}]",Peptides,['10.1016/j.peptides.2019.170134'] 3198,31345626,Adjuvant chemoradiotherapy versus radiotherapy alone in women with high-risk endometrial cancer (PORTEC-3): patterns of recurrence and post-hoc survival analysis of a randomised phase 3 trial.,"BACKGROUND The PORTEC-3 trial investigated the benefit of combined adjuvant chemotherapy and radiotherapy versus pelvic radiotherapy alone for women with high-risk endometrial cancer. We updated the analysis to investigate patterns of recurrence and did a post-hoc survival analysis. METHODS In the multicentre randomised phase 3 PORTEC-3 trial, women with high-risk endometrial cancer were eligible if they had International Federation of Gynaecology and Obstetrics (FIGO) 2009 stage I, endometrioid grade 3 cancer with deep myometrial invasion or lymphovascular space invasion, or both; stage II or III disease; or stage I-III disease with serous or clear cell histology; were aged 18 years and older; and had a WHO performance status of 0-2. Participants were randomly assigned (1:1) to receive radiotherapy alone (48·6 Gy in 1·8 Gy fractions given on 5 days per week) or chemoradiotherapy (two cycles of cisplatin 50 mg/m 2 given intravenously during radiotherapy, followed by four cycles of carboplatin AUC5 and paclitaxel 175 mg/m 2 given intravenously), by use of a biased coin minimisation procedure with stratification for participating centre, lymphadenectomy, stage, and histological type. The co-primary endpoints were overall survival and failure-free survival. Secondary endpoints of vaginal, pelvic, and distant recurrence were analysed according to the first site of recurrence. Survival endpoints were analysed by intention-to-treat, and adjusted for stratification factors. Competing risk methods were used for failure-free survival and recurrence. We did a post-hoc analysis to analyse patterns of recurrence with 1 additional year of follow-up. The study was closed on Dec 20, 2013; follow-up is ongoing. This study is registered with ISRCTN, number ISRCTN14387080, and ClinicalTrials.gov, number NCT00411138. FINDINGS Between Nov 23, 2006, and Dec 20, 2013, 686 women were enrolled, of whom 660 were eligible and evaluable (330 in the chemoradiotherapy group, and 330 in the radiotherapy-alone group). At a median follow-up of 72·6 months (IQR 59·9-85·6), 5-year overall survival was 81·4% (95% CI 77·2-85·8) with chemoradiotherapy versus 76·1% (71·6-80·9) with radiotherapy alone (adjusted hazard ratio [HR] 0·70 [95% CI 0·51-0·97], p=0·034), and 5-year failure-free survival was 76·5% (95% CI 71·5-80·7) versus 69·1% (63·8-73·8; HR 0·70 [0·52-0·94], p=0·016). Distant metastases were the first site of recurrence in most patients with a relapse, occurring in 78 of 330 women (5-year probability 21·4%; 95% CI 17·3-26·3) in the chemoradiotherapy group versus 98 of 330 (5-year probability 29·1%; 24·4-34·3) in the radiotherapy-alone group (HR 0·74 [95% CI 0·55-0·99]; p=0·047). Isolated vaginal recurrence was the first site of recurrence in one patient (0·3%; 95% CI 0·0-2·1) in both groups (HR 0·99 [95% CI 0·06-15·90]; p=0·99), and isolated pelvic recurrence was the first site of recurrence in three women (0·9% [95% CI 0·3-2·8]) in the chemoradiotherapy group versus four (0·9% [95% CI 0·3-2·8]) in the radiotherapy-alone group (HR 0·75 [95% CI 0·17-3·33]; p=0·71). At 5 years, only one grade 4 adverse event (ileus or obstruction) was reported (in the chemoradiotherapy group). At 5 years, reported grade 3 adverse events did not differ significantly between the two groups, occurring in 16 (8%) of 201 women in the chemoradiotherapy group versus ten (5%) of 187 in the radiotherapy-alone group (p=0·24). The most common grade 3 adverse event was hypertension (in four [2%] women in both groups). At 5 years, grade 2 or worse adverse events were reported in 76 (38%) of 201 women in the chemoradiotherapy group versus 43 (23%) of 187 in the radiotherapy-alone group (p=0·002). Sensory neuropathy persisted more often after chemoradiotherapy than after radiotherapy alone, with 5-year rates of grade 2 or worse neuropathy of 6% (13 of 201 women) versus 0% (0 of 187). No treatment-related deaths were reported. INTERPRETATION This updated analysis shows significantly improved overall survival and failure-free survival with chemoradiotherapy versus radiotherapy alone. This treatment schedule should be discussed and recommended, especially for women with stage III or serous cancers, or both, as part of shared decision making between doctors and patients. Follow-up is ongoing to evaluate long-term survival. FUNDING Dutch Cancer Society, Cancer Research UK, National Health and Medical Research Council, Project Grant, Cancer Australia Grant, Italian Medicines Agency, and the Canadian Cancer Society Research Institute.",2019,"At 5 years, only one grade 4 adverse event (ileus or obstruction) was reported (in the chemoradiotherapy group).","['2009 stage', 'women with high-risk endometrial cancer (PORTEC-3', 'I, endometrioid grade 3 cancer with deep myometrial invasion or lymphovascular space invasion, or both; stage II or III disease; or stage I-III disease with serous or clear cell histology; were aged 18 years and older; and had a WHO performance status of 0-2', '0·70', 'women with high-risk endometrial cancer', 'women with stage III or serous cancers', 'Between Nov 23, 2006, and Dec 20, 2013, 686 women were enrolled, of whom 660 were eligible and evaluable (330 in the chemoradiotherapy group, and 330 in the radiotherapy-alone group', 'women with high-risk endometrial cancer were eligible if they had International Federation of Gynaecology and Obstetrics (FIGO']","['radiotherapy-alone group (HR 0·75', 'combined adjuvant chemotherapy and radiotherapy versus pelvic radiotherapy alone', 'Adjuvant chemoradiotherapy versus radiotherapy alone', 'chemoradiotherapy versus radiotherapy', 'radiotherapy alone (48·6 Gy in 1·8 Gy fractions given on 5 days per week) or chemoradiotherapy (two cycles of cisplatin 50 mg/m 2 given intravenously during radiotherapy, followed by four cycles of carboplatin AUC5 and paclitaxel', 'radiotherapy', 'chemoradiotherapy']","['grade 2 or worse adverse events', '5-year rates of grade 2 or worse neuropathy', 'vaginal, pelvic, and distant recurrence', 'Isolated vaginal recurrence', 'grade 3 adverse events', 'overall survival and failure-free survival', 'Sensory neuropathy', '5-year overall survival', 'grade 4 adverse event (ileus or obstruction', 'Survival endpoints', '5-year failure-free survival', 'isolated pelvic recurrence']","[{'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0476089', 'cui_str': 'Endometrial Carcinoma'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0205125', 'cui_str': 'Depth (qualifier value)'}, {'cui': 'C0282173', 'cui_str': 'Space (Astronomy)'}, {'cui': 'C0441767', 'cui_str': 'Stage level 2 (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0441766', 'cui_str': 'Stage level 1 (qualifier value)'}, {'cui': 'C0440743', 'cui_str': 'Serous (qualifier value)'}, {'cui': 'C0229473', 'cui_str': 'Cell of Claudius (cell)'}, {'cui': 'C0344441', 'cui_str': 'Histologic test (procedure)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3 (qualifier value)'}, {'cui': 'C4517845', 'cui_str': '660'}, {'cui': 'C4517719', 'cui_str': '330 (qualifier value)'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}]","[{'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0085533', 'cui_str': 'Drug Therapy, Adjuvant'}, {'cui': 'C0030797', 'cui_str': 'Pelvic Region'}, {'cui': 'C3178761', 'cui_str': 'Adjuvant Radiochemotherapy'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C1264633', 'cui_str': 'Fractions of (qualifier value)'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0677547', 'cui_str': 'days/week (qualifier value)'}, {'cui': 'C4081040', 'cui_str': 'Cisplatin 50 MG [Platinol]'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0079083', 'cui_str': 'Carboplatin'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}]","[{'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C1457868', 'cui_str': 'Worsened'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0442874', 'cui_str': 'Neuropathy (disorder)'}, {'cui': 'C4521343', 'cui_str': 'Vaginal (intended site)'}, {'cui': 'C0030797', 'cui_str': 'Pelvic Region'}, {'cui': 'C0443203', 'cui_str': 'Distant (qualifier value)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0205409', 'cui_str': 'Isolated (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0151313', 'cui_str': 'Sensory neuropathy (disorder)'}, {'cui': 'C1258215', 'cui_str': 'Ileus'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}]",686.0,0.472097,"At 5 years, only one grade 4 adverse event (ileus or obstruction) was reported (in the chemoradiotherapy group).","[{'ForeName': 'Stephanie M', 'Initials': 'SM', 'LastName': 'de Boer', 'Affiliation': 'Department of Radiation Oncology, Leiden University Medical Center, Leiden, Netherlands. Electronic address: s.m.de_boer.onco@lumc.nl.'}, {'ForeName': 'Melanie E', 'Initials': 'ME', 'LastName': 'Powell', 'Affiliation': 'Department of Clinical Oncology, Barts Health NHS Trust, London, UK.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Mileshkin', 'Affiliation': 'Division of Cancer Medicine, Peter MacCallum Cancer Centre, Melbourne, VIC, Australia.'}, {'ForeName': 'Dionyssios', 'Initials': 'D', 'LastName': 'Katsaros', 'Affiliation': 'Department of Surgical Sciences, Gynecologic Oncology, Città della Salute and S Anna Hospital, University of Turin, Turin, Italy.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Bessette', 'Affiliation': 'Canadian Cancer Trials Group, Department of Obstetrics and Gynaecology, University of Sherbrooke, Sherbrooke, QC, Canada.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Haie-Meder', 'Affiliation': 'Department of Radiotherapy, Institut Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Petronella B', 'Initials': 'PB', 'LastName': 'Ottevanger', 'Affiliation': 'Department of Medical Oncology, Radboudumc, Nijmegen, Netherlands.'}, {'ForeName': 'Jonathan A', 'Initials': 'JA', 'LastName': 'Ledermann', 'Affiliation': 'Cancer Research UK, London, UK; UCL Cancer Trials Centre, UCL Cancer Institute, London, UK.'}, {'ForeName': 'Pearly', 'Initials': 'P', 'LastName': 'Khaw', 'Affiliation': 'Division of Radiation Oncology, Peter MacCallum Cancer Centre, Melbourne, VIC, Australia.'}, {'ForeName': 'Romerai', 'Initials': 'R', 'LastName': ""D'Amico"", 'Affiliation': 'Division of Radiation Oncology, ASST-Lecco, Ospedale AManzoni, Lecco, Italy.'}, {'ForeName': 'Anthony', 'Initials': 'A', 'LastName': 'Fyles', 'Affiliation': 'Canadian Cancer Trials Group, Radiation Medicine Program, Princess Margaret Cancer Centre, Toronto, ON, Canada.'}, {'ForeName': 'Marie-Helene', 'Initials': 'MH', 'LastName': 'Baron', 'Affiliation': 'Department of Radiotherapy, Centre Hospitalier Régional Universitaire de Besançon, Besançon, France.'}, {'ForeName': 'Ina M', 'Initials': 'IM', 'LastName': 'Jürgenliemk-Schulz', 'Affiliation': 'Department of Radiation Oncology, University Medical Center Utrecht, Netherlands.'}, {'ForeName': 'Henry C', 'Initials': 'HC', 'LastName': 'Kitchener', 'Affiliation': 'Institute of Cancer Sciences, University of Manchester, Manchester, UK.'}, {'ForeName': 'Hans W', 'Initials': 'HW', 'LastName': 'Nijman', 'Affiliation': 'Department of Gynaecologic Oncology, University Medical Center Groningen, University of Groningen, Groningen, Netherlands.'}, {'ForeName': 'Godfrey', 'Initials': 'G', 'LastName': 'Wilson', 'Affiliation': 'Department of Pathology, Central Manchester Hospitals NHS Foundation Trust, Manchester Royal Infirmary, Manchester, UK.'}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Brooks', 'Affiliation': 'Department of Radiation Oncology, Auckland City Hospital, Auckland, New Zealand.'}, {'ForeName': 'Sergio', 'Initials': 'S', 'LastName': 'Gribaudo', 'Affiliation': 'Department of Oncology - Radiotherapy, A.O.U. Città della Salute e della Scienza di Torino, Turin, Italy.'}, {'ForeName': 'Diane', 'Initials': 'D', 'LastName': 'Provencher', 'Affiliation': 'Department of Gynaecologic Oncology, Hôpital Notre-Dame de Montreal, Montreal, QC, Canada.'}, {'ForeName': 'Chantal', 'Initials': 'C', 'LastName': 'Hanzen', 'Affiliation': 'Department of Radiation Oncology, Centre Henri Becquerel, Rouen, France.'}, {'ForeName': 'Roy F', 'Initials': 'RF', 'LastName': 'Kruitwagen', 'Affiliation': 'Department of Obstetrics and Gynaecology, Maastricht University Medical Centre, Maastricht, Netherlands; GROW - School for Oncology and Developmental Biology, Maastricht, Netherlands.'}, {'ForeName': 'Vincent T H B M', 'Initials': 'VTHBM', 'LastName': 'Smit', 'Affiliation': 'Department of Pathology, Leiden University Medical Center, Leiden, Netherlands.'}, {'ForeName': 'Naveena', 'Initials': 'N', 'LastName': 'Singh', 'Affiliation': 'Department of Cellular Pathology, Barts Health NHS Trust, London, UK.'}, {'ForeName': 'Viet', 'Initials': 'V', 'LastName': 'Do', 'Affiliation': 'Department of Radiation Oncology, Liverpool Cancer Therapy Centre, Liverpool, NSW, Australia.'}, {'ForeName': 'Andrea', 'Initials': 'A', 'LastName': 'Lissoni', 'Affiliation': 'Gynecologic Oncology Unit, Department of Obstetrics and Gynecology, San Gerardo Hospital, University of Milano-Bicocca, Monza, Italy.'}, {'ForeName': 'Remi A', 'Initials': 'RA', 'LastName': 'Nout', 'Affiliation': 'Department of Radiation Oncology, Leiden University Medical Center, Leiden, Netherlands.'}, {'ForeName': 'Amanda', 'Initials': 'A', 'LastName': 'Feeney', 'Affiliation': 'Cancer Research UK, London, UK; UCL Cancer Trials Centre, UCL Cancer Institute, London, UK.'}, {'ForeName': 'Karen W', 'Initials': 'KW', 'LastName': 'Verhoeven-Adema', 'Affiliation': 'Comprehensive Cancer Center Netherlands, Rotterdam, Netherlands.'}, {'ForeName': 'Hein', 'Initials': 'H', 'LastName': 'Putter', 'Affiliation': 'Department of Medical Statistics, Leiden University Medical Center, Leiden, Netherlands.'}, {'ForeName': 'Carien L', 'Initials': 'CL', 'LastName': 'Creutzberg', 'Affiliation': 'Department of Radiation Oncology, Leiden University Medical Center, Leiden, Netherlands.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Oncology,['10.1016/S1470-2045(19)30395-X'] 3199,31345627,"Pembrolizumab versus ipilimumab in advanced melanoma (KEYNOTE-006): post-hoc 5-year results from an open-label, multicentre, randomised, controlled, phase 3 study.","BACKGROUND Pembrolizumab improved progression-free survival and overall survival versus ipilimumab in patients with advanced melanoma and is now a standard of care in the first-line setting. However, the optimal duration of anti-PD-1 administration is unknown. We present results from 5 years of follow-up of patients in KEYNOTE-006. METHODS KEYNOTE-006 was an open-label, multicentre, randomised, controlled, phase 3 study done at 87 academic institutions, hospitals, and cancer centres in 16 countries. Patients aged at least 18 years with Eastern Cooperative Oncology Group performance status of 0 or 1, ipilimumab-naive histologically confirmed advanced melanoma with known BRAF V600 status and up to one previous systemic therapy were randomly assigned (1:1:1) to intravenous pembrolizumab 10 mg/kg every 2 weeks or every 3 weeks or four doses of intravenous ipilimumab 3 mg/kg every 3 weeks. Treatments were assigned using a centralised, computer-generated allocation schedule with blocked randomisation within strata. Exploratory combination of data from the two pembrolizumab dosing regimen groups was not protocol-specified. Pembrolizumab treatment continued for up to 24 months. Eligible patients who discontinued pembrolizumab with stable disease or better after receiving at least 24 months of pembrolizumab or discontinued with complete response after at least 6 months of pembrolizumab and then progressed could receive an additional 17 cycles of pembrolizumab. Co-primary endpoints were overall survival and progression-free survival. Efficacy was analysed in all randomly assigned patients, and safety was analysed in all randomly assigned patients who received at least one dose of study treatment. Exploratory assessment of efficacy and safety at 5 years' follow-up was not specified in the protocol. Data cutoff for this analysis was Dec 3, 2018. Recruitment is closed; the study is ongoing. This study is registered with ClinicalTrials.gov, number NCT01866319. FINDINGS Between Sept 18, 2013, and March 3, 2014, 834 patients were enrolled and randomly assigned to receive pembrolizumab (every 2 weeks, n=279; every 3 weeks, n=277), or ipilimumab (n=278). After a median follow-up of 57·7 months (IQR 56·7-59·2) in surviving patients, median overall survival was 32·7 months (95% CI 24·5-41·6) in the combined pembrolizumab groups and 15·9 months (13·3-22·0) in the ipilimumab group (hazard ratio [HR] 0·73, 95% CI 0·61-0·88, p=0·00049). Median progression-free survival was 8·4 months (95% CI 6·6-11·3) in the combined pembrolizumab groups versus 3·4 months (2·9-4·2) in the ipilimumab group (HR 0·57, 95% CI 0·48-0·67, p<0·0001). Grade 3-4 treatment-related adverse events occurred in 96 (17%) of 555 patients in the combined pembrolizumab groups and in 50 (20%) of 256 patients in the ipilimumab group; the most common of these events were colitis (11 [2%] vs 16 [6%]), diarrhoea (ten [2%] vs seven [3%]), and fatigue (four [<1%] vs three [1%]). Any-grade serious treatment-related adverse events occurred in 75 (14%) patients in the combined pembrolizumab groups and in 45 (18%) patients in the ipilimumab group. One patient assigned to pembrolizumab died from treatment-related sepsis. INTERPRETATION Pembrolizumab continued to show superiority over ipilimumab after almost 5 years of follow-up. These results provide further support for use of pembrolizumab in patients with advanced melanoma. FUNDING Merck Sharp & Dohme.",2019,"INTERPRETATION Pembrolizumab continued to show superiority over ipilimumab after almost 5 years of follow-up.","['patients with advanced melanoma', 'Eligible patients who discontinued pembrolizumab with stable disease or better after receiving at least 24 months of pembrolizumab or discontinued with complete response after at least 6 months of', 'Between Sept 18, 2013, and March 3, 2014, 834 patients', '87 academic institutions, hospitals, and cancer centres in 16 countries', 'Patients aged at least 18 years with Eastern Cooperative Oncology Group performance status of 0 or 1, ipilimumab-naive histologically confirmed advanced melanoma with known BRAF V600 status and up to one previous systemic therapy']","['Pembrolizumab', 'intravenous ipilimumab', 'pembrolizumab', 'ipilimumab', 'intravenous pembrolizumab', 'Pembrolizumab versus ipilimumab']","['fatigue', 'diarrhoea', 'adverse events', 'progression-free survival and overall survival', 'efficacy and safety', 'overall survival and progression-free survival', 'Median progression-free survival', 'Efficacy', 'median overall survival']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0025202', 'cui_str': 'Malignant Melanoma'}, {'cui': 'C1706472', 'cui_str': 'Discontinue - dosing instruction imperative'}, {'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C0205360', 'cui_str': 'Stable (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C1272753', 'cui_str': 'Institution'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0454664', 'cui_str': 'Country (geographic location)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1520224', 'cui_str': 'Eastern Cooperative Oncology Group performance status'}, {'cui': 'C1367202', 'cui_str': 'ipilimumab'}, {'cui': 'C1456348', 'cui_str': 'Confirm'}, {'cui': 'C0205309', 'cui_str': 'Known (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C3658706', 'cui_str': 'pembrolizumab'}, {'cui': 'C0348016', 'cui_str': 'Intravenous (qualifier value)'}, {'cui': 'C1367202', 'cui_str': 'ipilimumab'}]","[{'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]",834.0,0.382841,"INTERPRETATION Pembrolizumab continued to show superiority over ipilimumab after almost 5 years of follow-up.","[{'ForeName': 'Caroline', 'Initials': 'C', 'LastName': 'Robert', 'Affiliation': 'Institut de Cancérologie Gustave Roussy, Université Paris-Sud, Villejuif, France. Electronic address: caroline.robert@gustaveroussy.fr.'}, {'ForeName': 'Antoni', 'Initials': 'A', 'LastName': 'Ribas', 'Affiliation': 'David Geffen School of Medicine, University of California, Los Angeles, CA, USA.'}, {'ForeName': 'Jacob', 'Initials': 'J', 'LastName': 'Schachter', 'Affiliation': 'Sheba Medical Center at Tel HaShomer, Tel HaShomer, Ramat Gan, Israel.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Arance', 'Affiliation': 'Hospital Clinic de Barcelona, Barcelona, Spain.'}, {'ForeName': 'Jean-Jacques', 'Initials': 'JJ', 'LastName': 'Grob', 'Affiliation': 'Aix Marseille Université, Hôpital de la Timone, Marseille, France.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Mortier', 'Affiliation': 'Université Lille, Centre Hospitalier Regional Universitaire de Lille, Lille, France.'}, {'ForeName': 'Adil', 'Initials': 'A', 'LastName': 'Daud', 'Affiliation': 'University of California San Francisco, San Francisco, CA, USA.'}, {'ForeName': 'Matteo S', 'Initials': 'MS', 'LastName': 'Carlino', 'Affiliation': 'Westmead and Blacktown Hospitals, Melanoma Institute Australia, and The University of Sydney, Sydney, NSW, Australia.'}, {'ForeName': 'Catriona M', 'Initials': 'CM', 'LastName': 'McNeil', 'Affiliation': ""Chris O'Brien Lifehouse, Royal Prince Alfred Hospital, and Melanoma Institute Australia, Camperdown, NSW, Australia.""}, {'ForeName': 'Michal', 'Initials': 'M', 'LastName': 'Lotem', 'Affiliation': 'Sharett Institute of Oncology, Hadassah Hebrew Medical Center, Jerusalem, Israel.'}, {'ForeName': 'James M G', 'Initials': 'JMG', 'LastName': 'Larkin', 'Affiliation': 'Royal Marsden Hospital, London, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Lorigan', 'Affiliation': 'University of Manchester and the Christie NHS Foundation Trust, Manchester, UK.'}, {'ForeName': 'Bart', 'Initials': 'B', 'LastName': 'Neyns', 'Affiliation': 'Universitair Ziekenhuis Brussel, Brussels, Belgium.'}, {'ForeName': 'Christian U', 'Initials': 'CU', 'LastName': 'Blank', 'Affiliation': 'Netherlands Cancer Institute, Amsterdam, Netherlands.'}, {'ForeName': 'Teresa M', 'Initials': 'TM', 'LastName': 'Petrella', 'Affiliation': 'Sunnybrook Health Sciences Centre, Toronto, ON, Canada.'}, {'ForeName': 'Omid', 'Initials': 'O', 'LastName': 'Hamid', 'Affiliation': 'The Angeles Clinic and Research Institute, Los Angeles, CA, USA.'}, {'ForeName': 'Shu-Chih', 'Initials': 'SC', 'LastName': 'Su', 'Affiliation': 'Merck & Co, Kenilworth, NJ, USA.'}, {'ForeName': 'Clemens', 'Initials': 'C', 'LastName': 'Krepler', 'Affiliation': 'Merck & Co, Kenilworth, NJ, USA.'}, {'ForeName': 'Nageatte', 'Initials': 'N', 'LastName': 'Ibrahim', 'Affiliation': 'Merck & Co, Kenilworth, NJ, USA.'}, {'ForeName': 'Georgina V', 'Initials': 'GV', 'LastName': 'Long', 'Affiliation': 'Melanoma Institute Australia, University of Sydney, Mater Hospital, and Royal North Shore Hospital, Sydney, NSW, Australia.'}]",The Lancet. Oncology,['10.1016/S1470-2045(19)30388-2'] 3200,32001798,"Daratumumab plus lenalidomide and dexamethasone in relapsed/refractory multiple myeloma: extended follow-up of POLLUX, a randomized, open-label, phase 3 study.","In POLLUX, daratumumab (D) plus lenalidomide/dexamethasone (Rd) reduced the risk of disease progression or death by 63% and increased the overall response rate (ORR) versus Rd in relapsed/refractory multiple myeloma (RRMM). Updated efficacy and safety after >3 years of follow-up are presented. Patients (N = 569) with ≥1 prior line received Rd (lenalidomide, 25 mg, on Days 1-21 of each 28-day cycle; dexamethasone, 40 mg, weekly) ± daratumumab at the approved dosing schedule. Minimal residual disease (MRD) was assessed by next-generation sequencing. After 44.3 months median follow-up, D-Rd prolonged progression-free survival (PFS) in the intent-to-treat population (median 44.5 vs 17.5 months; HR, 0.44; 95% CI, 0.35-0.55; P < 0.0001) and in patient subgroups. D-Rd demonstrated higher ORR (92.9 vs 76.4%; P < 0.0001) and deeper responses, including complete response or better (56.6 vs 23.2%; P < 0.0001) and MRD negativity (10 -5 ; 30.4 vs 5.3%; P < 0.0001). Median time to next therapy was prolonged with D-Rd (50.6 vs 23.1 months; HR, 0.39; 95% CI, 0.31-0.50; P < 0.0001). Median PFS on subsequent line of therapy (PFS2) was not reached with D-Rd versus 31.7 months with Rd (HR, 0.53; 95% CI, 0.42-0.68; P < 0.0001). No new safety concerns were reported. These data support using D-Rd in patients with RRMM after first relapse.",2020,"D-Rd demonstrated higher ORR (92.9 vs 76.4%; P < 0.0001) and deeper responses, including complete response or better (56.6 vs 23.2%; P < 0.0001) and MRD negativity (10 -5 ; 30.4 vs 5.3%; P < 0.0001).","['Patients (N\u2009=\u2009569) with ≥1 prior line received', 'relapsed/refractory multiple myeloma']","['Rd (lenalidomide', 'POLLUX, daratumumab (D) plus lenalidomide/dexamethasone (Rd', 'Daratumumab plus lenalidomide and dexamethasone', 'dexamethasone, 40\u2009mg, weekly)\u2009±\u2009daratumumab']","['Median time to next therapy', 'D-Rd prolonged progression-free survival (PFS', 'risk of disease progression or death', 'MRD negativity', 'Minimal residual disease (MRD', 'overall response rate (ORR', 'ORR', 'Median PFS on subsequent line of therapy (PFS2']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C0026764', 'cui_str': 'Myelomatosis'}]","[{'cui': 'C1144149', 'cui_str': 'lenalidomide'}, {'cui': 'C2346801', 'cui_str': 'daratumumab'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0242656', 'cui_str': 'Disease Progression'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0242596', 'cui_str': 'Minimal Disease, Residual'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}]",569.0,0.152505,"D-Rd demonstrated higher ORR (92.9 vs 76.4%; P < 0.0001) and deeper responses, including complete response or better (56.6 vs 23.2%; P < 0.0001) and MRD negativity (10 -5 ; 30.4 vs 5.3%; P < 0.0001).","[{'ForeName': 'Nizar J', 'Initials': 'NJ', 'LastName': 'Bahlis', 'Affiliation': 'University of Calgary, Charbonneau Cancer Research Institute, Calgary, AB, Canada. nbahlis@ucalgary.ca.'}, {'ForeName': 'Meletios A', 'Initials': 'MA', 'LastName': 'Dimopoulos', 'Affiliation': 'The National and Kapodistrian University of Athens, Athens, Greece.'}, {'ForeName': 'Darrell J', 'Initials': 'DJ', 'LastName': 'White', 'Affiliation': 'QEII Health Sciences Center and Dalhousie University, Halifax, NS, Canada.'}, {'ForeName': 'Lotfi', 'Initials': 'L', 'LastName': 'Benboubker', 'Affiliation': ""Service d'Hématologie et Thérapie Cellulaire, Hôpital Bretonneau, Centre Hospitalier Régional Universitaire (CHRU), Tours, France.""}, {'ForeName': 'Gordon', 'Initials': 'G', 'LastName': 'Cook', 'Affiliation': ""St James's Institute of Oncology, Leeds Teaching Hospitals National Health Service Trust and University of Leeds, Leeds, UK.""}, {'ForeName': 'Merav', 'Initials': 'M', 'LastName': 'Leiba', 'Affiliation': 'Assuta University Hospital, Faculty of Health Science, Ben-Gurion University of the Negev, Beersheba, Israel.'}, {'ForeName': 'P Joy', 'Initials': 'PJ', 'LastName': 'Ho', 'Affiliation': 'Institute of Haematology, Royal Prince Alfred Hospital, Camperdown, NSW, Australia.'}, {'ForeName': 'Kihyun', 'Initials': 'K', 'LastName': 'Kim', 'Affiliation': 'Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea.'}, {'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Takezako', 'Affiliation': 'Department of Hematology, National Hospital Organization Disaster Medical Center of Japan, Tachikawa, Japan.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Moreau', 'Affiliation': 'Hematology, University Hospital Hôtel-Dieu, Nantes, France.'}, {'ForeName': 'Jonathan L', 'Initials': 'JL', 'LastName': 'Kaufman', 'Affiliation': 'Winship Cancer Institute, Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Krevvata', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, PA, USA.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Chiu', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, PA, USA.'}, {'ForeName': 'Xiang', 'Initials': 'X', 'LastName': 'Qin', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, PA, USA.'}, {'ForeName': 'Linda', 'Initials': 'L', 'LastName': 'Okonkwo', 'Affiliation': 'Janssen Research & Development, LLC, Raritan, NJ, USA.'}, {'ForeName': 'Sonali', 'Initials': 'S', 'LastName': 'Trivedi', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, PA, USA.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Ukropec', 'Affiliation': 'Janssen Global Medical Affairs, Horsham, PA, USA.'}, {'ForeName': 'Ming', 'Initials': 'M', 'LastName': 'Qi', 'Affiliation': 'Janssen Research & Development, LLC, Spring House, PA, USA.'}, {'ForeName': 'Jesus', 'Initials': 'J', 'LastName': 'San-Miguel', 'Affiliation': 'Clínica Universidad de Navarra-Centro de Investigación Médica Aplicada, Instituto de Investigación Sanitaria de Navarra, Centro de Investigación Biomédica en Red de Cáncer, Pamplona, Spain.'}]",Leukemia,['10.1038/s41375-020-0711-6'] 3201,31479035,Comparative effects of high-intensity interval training with combined training on physical function markers in obese postmenopausal women: a randomized controlled trial.,"OBJECTIVES This study compared the effects of high-intensity interval training (HIIT) with effects of combined training (CT) on physical function, body composition, and muscle strength in obese postmenopausal women (PW) (trial registration: NCT03200639). METHODS PW were randomized to CT (n = 12) and HIIT (n = 12). The CT group performed 30 minutes of moderate walking at 70% of maximum heart rate (MHR) and five resistance exercises at 70% of one repetition maximum (1RM) for 12 weeks. The HIIT group performed 10 sets of vigorous exercises (30 seconds (s) of stair climbing and 30 s of body weight squats) at >80% MHR interspersed by a light walk (recovery period at 60% MHR). RESULTS Both groups reduced body fat percentage (0.5%), chair stand (3 s) and increased leg lean mass (0.3 kg). Only the CT, however, increased muscle strength (29%) and fast walking speed (5%) compared with HIIT. The fast walking speed changes were partially explained by the muscle strength changes (36%, r = 0.60, P = 0.027) in the CT group. CONCLUSIONS These results suggest that HIIT is an alternative time-efficient protocol for improving chair stand and body composition when compared with CT, whereas only CT is an efficient protocol for improving muscular strength and fast walking speed in obese PW. Thus, CT must be prioritized when the increase of muscular strength and fast walking speed are the goals of training. : Video Summary: Supplemental Digital Content 1, http://links.lww.com/MENO/A443.",2019,"Both groups reduced body fat percentage (0.5%), chair stand (3 s) and increased leg lean mass (0.3 kg).","['obese postmenopausal women (PW', 'obese postmenopausal women']","['CT', 'high-intensity interval training (HIIT', 'vigorous exercises (30 seconds (s) of stair climbing and 30\u200as of body weight squats) at >80% MHR interspersed by a light walk (recovery period at 60% MHR', 'high-intensity interval training with combined training', 'combined training (CT', ' Video Summary: Supplemental Digital Content 1, http://links.lww.com/MENO/A443']","['muscle strength changes', 'body fat percentage', 'muscular strength and fast walking speed', 'fast walking speed', 'leg lean mass', 'muscle strength', 'physical function, body composition, and muscle strength', 'physical function markers']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}]","[{'cui': 'C4277545', 'cui_str': 'High-Intensity Intermittent Exercise'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C1290942', 'cui_str': 'Stair Navigation'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0241236', 'cui_str': 'Does squat (finding)'}, {'cui': 'C0332264', 'cui_str': 'Light (weight) (qualifier value)'}, {'cui': 'C0080331', 'cui_str': 'Walking'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray (qualifier value)'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}]","[{'cui': 'C0517349', 'cui_str': 'Muscle Strength'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0344335', 'cui_str': 'Body Fat'}, {'cui': 'C0442025', 'cui_str': 'Muscular (qualifier value)'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C2009910', 'cui_str': 'Gait Speed'}, {'cui': 'C0023216', 'cui_str': 'Membrum inferius'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0005885', 'cui_str': 'Body Composition'}]",,0.0448072,"Both groups reduced body fat percentage (0.5%), chair stand (3 s) and increased leg lean mass (0.3 kg).","[{'ForeName': 'Paulo R P', 'Initials': 'PRP', 'LastName': 'Nunes', 'Affiliation': 'Exercise Biology Research Group (BioEx), Federal University of Triângulo Mineiro (UFTM), Uberaba, Minas Gerais, Brazil.'}, {'ForeName': 'Fernanda M', 'Initials': 'FM', 'LastName': 'Martins', 'Affiliation': 'Exercise Biology Research Group (BioEx), Federal University of Triângulo Mineiro (UFTM), Uberaba, Minas Gerais, Brazil.'}, {'ForeName': 'Aletéia P', 'Initials': 'AP', 'LastName': 'Souza', 'Affiliation': 'Exercise Biology Research Group (BioEx), Federal University of Triângulo Mineiro (UFTM), Uberaba, Minas Gerais, Brazil.'}, {'ForeName': 'Marcelo A S', 'Initials': 'MAS', 'LastName': 'Carneiro', 'Affiliation': 'Exercise Biology Research Group (BioEx), Federal University of Triângulo Mineiro (UFTM), Uberaba, Minas Gerais, Brazil.'}, {'ForeName': 'Rosekeila S', 'Initials': 'RS', 'LastName': 'Nomelini', 'Affiliation': 'Oncology Research Institute (IPON), Gynecology and Obstetrics Program, Federal University of Triângulo Mineiro (UFTM), Uberaba, Minas Gerais, Brazil.'}, {'ForeName': 'Márcia A', 'Initials': 'MA', 'LastName': 'Michelin', 'Affiliation': 'Oncology Research Institute (IPON), Gynecology and Obstetrics Program, Federal University of Triângulo Mineiro (UFTM), Uberaba, Minas Gerais, Brazil.'}, {'ForeName': 'Eddie F C', 'Initials': 'EFC', 'LastName': 'Murta', 'Affiliation': 'Oncology Research Institute (IPON), Gynecology and Obstetrics Program, Federal University of Triângulo Mineiro (UFTM), Uberaba, Minas Gerais, Brazil.'}, {'ForeName': 'Erick P', 'Initials': 'EP', 'LastName': 'de Oliveira', 'Affiliation': 'Exercise Biology Research Group (BioEx), Federal University of Triângulo Mineiro (UFTM), Uberaba, Minas Gerais, Brazil.'}, {'ForeName': 'Fábio L', 'Initials': 'FL', 'LastName': 'Orsatti', 'Affiliation': 'Exercise Biology Research Group (BioEx), Federal University of Triângulo Mineiro (UFTM), Uberaba, Minas Gerais, Brazil.'}]","Menopause (New York, N.Y.)",['10.1097/GME.0000000000001399'] 3202,31990581,Effectiveness of collagen supplementation on pain scores in healthy individuals with self-reported knee pain: a randomized controlled trial.,"The purpose of this study was to examine the effects of 12 weeks collagen peptide (CP) supplementation on knee pain and function in individuals with self-reported knee pain. Healthy physically active individuals ( n = 167; aged 63 [interquartile range = 56-68] years) with self-reported knee pain received 10 g/day of CP or placebo for 12 weeks. Knee pain and function were measured with the Visual Analog Scale (VAS), the Lysholm questionnaire, and the Knee injury and Osteoarthritis Outcome Score (KOOS). Furthermore, we assessed changes in inflammatory, cartilage, and bone (bio)markers. Measurements were conducted at baseline and after 12 weeks of supplementation. Baseline VAS did not differ between CP and placebo (4.7 [2.5-6.1] vs. 4.7 [2.8-6.2], p = 0.50), whereas a similar decrease in VAS was observed after supplementation (-1.6 ± 2.4 vs. -1.9 ± 2.6, p = 0.42). The KOOS and Lysholm scores increased after supplementation in both groups ( p values < 0.001), whereas the increase in the KOOS and Lysholm scores did not differ between groups ( p = 0.28 and p = 0.76, respectively). Furthermore, CP did not impact inflammatory, cartilage, and bone (bio)markers ( p values > 0.05). A reduced knee pain and improved knee function were observed following supplementation, but changes were similar between groups. This suggests that CP supplementation over a 12-week period does not reduce knee pain in healthy, active, middle-aged to elderly individuals. Novelty CP supplementation over a 12-week period does not reduce knee pain in healthy, active, middle-aged to elderly individuals. CP supplementation over a 12-week period does not impact on inflammatory, cartilage, and bone (bio)markers in healthy, active, middle-aged to elderly individuals.",2020,"The KOOS and Lysholm scores increased after supplementation in both groups (p-values<0.001), whereas the increase in KOOS and Lysholm score did not differ between groups (p=0.28 and p=0.76, respectively).","['individuals with self-reported knee pain. N=167', 'healthy individuals with self-reported knee pain', 'Healthy physically active individuals (63[IQR=56-68] years) with self-reported knee pain received 10 g/day of', 'healthy active middle-aged to elderly individuals']","['CP and placebo', 'collagen peptide (CP) supplementation', 'collagen supplementation', 'CP supplementation', 'CP or placebo']","['Knee pain and function', 'inflammatory-, cartilage- and bone (bio)markers', 'knee pain and function', 'KOOS and Lysholm scores', 'KOOS and Lysholm score', 'Baseline VAS', 'Visual Analog Scale (VAS), Lysholm questionnaire and Knee injury and Osteoarthritis Outcome Score (KOOS', 'pain scores', 'VAS', 'knee pain', 'knee pain and improved knee function']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0231749', 'cui_str': 'Knee pain (finding)'}, {'cui': 'C0556453', 'cui_str': 'Physically active (finding)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1318182', 'cui_str': '10G'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0205847', 'cui_str': 'Middle Aged'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}, {'cui': 'C0030956', 'cui_str': 'Peptides'}]","[{'cui': 'C0231749', 'cui_str': 'Knee pain (finding)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0007301', 'cui_str': 'Cartilage'}, {'cui': 'C0181734', 'cui_str': 'Bone marker'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0022744', 'cui_str': 'Knee Injuries'}, {'cui': 'C0029408', 'cui_str': 'Arthritis, Degenerative'}, {'cui': 'C0582148', 'cui_str': 'Pain score (observable entity)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}]",167.0,0.0901257,"The KOOS and Lysholm scores increased after supplementation in both groups (p-values<0.001), whereas the increase in KOOS and Lysholm score did not differ between groups (p=0.28 and p=0.76, respectively).","[{'ForeName': 'Coen C W G', 'Initials': 'CCWG', 'LastName': 'Bongers', 'Affiliation': 'Radboud Institute for Health Sciences, Department of Physiology, Radboud University Medical Center, Nijmegen 6500HB, the Netherlands.'}, {'ForeName': 'Dominique S M', 'Initials': 'DSM', 'LastName': 'Ten Haaf', 'Affiliation': 'Radboud Institute for Health Sciences, Department of Physiology, Radboud University Medical Center, Nijmegen 6500HB, the Netherlands.'}, {'ForeName': 'Milène', 'Initials': 'M', 'LastName': 'Catoire', 'Affiliation': 'Radboud Institute for Health Sciences, Department of Physiology, Radboud University Medical Center, Nijmegen 6500HB, the Netherlands.'}, {'ForeName': 'Bregina', 'Initials': 'B', 'LastName': 'Kersten', 'Affiliation': 'Radboud Institute for Health Sciences, Department of Physiology, Radboud University Medical Center, Nijmegen 6500HB, the Netherlands.'}, {'ForeName': 'Jeroen A', 'Initials': 'JA', 'LastName': 'Wouters', 'Affiliation': 'Sports Centre Papendal/Eat2Move, Arnhem 6816VD, the Netherlands.'}, {'ForeName': 'Thijs M H', 'Initials': 'TMH', 'LastName': 'Eijsvogels', 'Affiliation': 'Radboud Institute for Health Sciences, Department of Physiology, Radboud University Medical Center, Nijmegen 6500HB, the Netherlands.'}, {'ForeName': 'Maria T E', 'Initials': 'MTE', 'LastName': 'Hopman', 'Affiliation': 'Radboud Institute for Health Sciences, Department of Physiology, Radboud University Medical Center, Nijmegen 6500HB, the Netherlands.'}]","Applied physiology, nutrition, and metabolism = Physiologie appliquee, nutrition et metabolisme",['10.1139/apnm-2019-0654'] 3203,30772600,Rickets severity predicts clinical outcomes in children with X-linked hypophosphatemia: Utility of the radiographic Rickets Severity Score.,"The Rickets Severity Score (RSS) was used to evaluate X-linked hypophosphatemic rickets (XLH), a genetic disorder mediated by increased circulating FGF23. The reliability of the RSS was assessed using data from a randomized, phase 2 clinical trial that evaluated the effects of burosumab, a fully human anti-FGF23 monoclonal antibody, in 52 children with XLH ages 5 to 12 years. Bilateral knee and wrist radiographs were obtained at baseline, week 40, and week 64. We evaluated the relationships of the RSS to the Radiographic Global Impression of Change (RGI-C), serum alkaline phosphatase (ALP), height Z-score, 6-minute walk test (6MWT) percent predicted, and the Pediatric Orthopedic Society of North America Pediatric Outcomes Data Collection Instrument (POSNA-PODCI). The RSS showed moderate-to-substantial inter-rater reliability (weighted kappa, 0.45-0.65; Pearson correlation coefficient (r), 0.83-0.89) and substantial intra-rater reliability (weighted Kappa, 0.66; r = 0.91). Baseline RSS correlated with serum ALP (r = 0.47). Baseline RSS identified two subgroups (higher [RSS ≥1.5] and lower RSS [RSS <1.5]) that discriminated between subjects with greater and lesser rachitic disease. Higher RSS was associated with more severe clinical features, including impaired growth (Z-score, -2.12 vs -1.44) and walking ability (6MWT percent predicted, 77% vs 86%), more severe self-reported pain (29.9 [more severe] vs 45.3 [less severe]) and less physical function (29.6 [more severe] vs 40.9 [less severe]). During burosumab treatment, greater reductions in RSS corresponded to higher RGI-C global scores (r = -0.65). Improvements in RSS correlated with decreased serum ALP (r = 0.47). These results show the reliability of the RSS in XLH, and demonstrate that higher RSS values are associated with greater biochemical, clinical, and functional impairments in children with XLH.",2019,"Higher RSS was associated with more severe clinical features, including impaired growth (Z-score, -2.12 vs -1.44) and walking ability (6MWT percent predicted, 77% vs 86%), more severe self-reported pain (29.9 [more severe] vs 45.3 [less severe]) and less physical function (29.6 [more severe] vs 40.9 [less severe]).","['children with XLH', 'children with X-linked hypophosphatemia', '52 children with XLH ages 5 to 12\u202fyears']",[],"['severe self-reported pain', 'physical function', 'Bilateral knee and wrist radiographs', 'Radiographic Global Impression of Change (RGI-C), serum alkaline phosphatase (ALP), height Z-score, 6-minute walk test (6MWT) percent predicted, and the Pediatric Orthopedic Society of North America Pediatric Outcomes Data Collection Instrument (POSNA-PODCI', 'walking ability', 'RSS', 'moderate-to-substantial inter-rater reliability', 'substantial intra-rater reliability', 'serum ALP', 'RGI-C global scores', 'Rickets Severity Score (RSS']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C3540852', 'cui_str': 'Hypophosphatemia, X-Linked'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]",[],"[{'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0238767', 'cui_str': 'Right and left (qualifier value)'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C0043262', 'cui_str': 'Wrist'}, {'cui': 'C1306645', 'cui_str': 'Plain x-ray'}, {'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0036776', 'cui_str': 'Serum alkaline phosphatase measurement'}, {'cui': 'C0871421', 'cui_str': 'Z-score'}, {'cui': 'C0430515', 'cui_str': '6-Minute Walk Test'}, {'cui': 'C0439165', 'cui_str': 'Percent (property) (qualifier value)'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C0029355', 'cui_str': 'Orthopedics'}, {'cui': 'C0037455', 'cui_str': 'Societies'}, {'cui': 'C0028405', 'cui_str': 'North America'}, {'cui': 'C0600644', 'cui_str': 'Collection'}, {'cui': 'C4551823', 'cui_str': 'instruments'}, {'cui': 'C0559964', 'cui_str': 'Ambulation ability'}, {'cui': 'C2699011', 'cui_str': 'Really Simple Syndication'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205103', 'cui_str': 'Intermediate (qualifier value)'}, {'cui': 'C0035035', 'cui_str': 'Reliability (Epidemiology)'}, {'cui': 'C0347985', 'cui_str': 'During values (qualifier value)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0035579', 'cui_str': 'Rachitis'}, {'cui': 'C0457451', 'cui_str': 'Severity score (qualifier value)'}]",52.0,0.048852,"Higher RSS was associated with more severe clinical features, including impaired growth (Z-score, -2.12 vs -1.44) and walking ability (6MWT percent predicted, 77% vs 86%), more severe self-reported pain (29.9 [more severe] vs 45.3 [less severe]) and less physical function (29.6 [more severe] vs 40.9 [less severe]).","[{'ForeName': 'Tom D', 'Initials': 'TD', 'LastName': 'Thacher', 'Affiliation': 'Mayo Clinic, Rochester, MN, USA. Electronic address: Thacher.Thomas@mayo.edu.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Pettifor', 'Affiliation': 'MRC/Wits Developmental Pathways for Health Research Unit, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.'}, {'ForeName': 'Peter J', 'Initials': 'PJ', 'LastName': 'Tebben', 'Affiliation': 'Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Ana L', 'Initials': 'AL', 'LastName': 'Creo', 'Affiliation': 'Mayo Clinic, Rochester, MN, USA.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Skrinar', 'Affiliation': 'Ultragenyx Pharmaceutical Inc., Novato, CA, USA.'}, {'ForeName': 'Meng', 'Initials': 'M', 'LastName': 'Mao', 'Affiliation': 'Ultragenyx Pharmaceutical Inc., Novato, CA, USA.'}, {'ForeName': 'Chao-Yin', 'Initials': 'CY', 'LastName': 'Chen', 'Affiliation': 'Ultragenyx Pharmaceutical Inc., Novato, CA, USA.'}, {'ForeName': 'Ting', 'Initials': 'T', 'LastName': 'Chang', 'Affiliation': 'Ultragenyx Pharmaceutical Inc., Novato, CA, USA.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'San Martin', 'Affiliation': 'Ultragenyx Pharmaceutical Inc., Novato, CA, USA.'}, {'ForeName': 'Thomas O', 'Initials': 'TO', 'LastName': 'Carpenter', 'Affiliation': 'Yale University School of Medicine, New Haven, CT, USA.'}]",Bone,['10.1016/j.bone.2019.02.010'] 3204,31688572,"Early onset of action with a 17β-estradiol, softgel, vaginal insert for treating vulvar and vaginal atrophy and moderate to severe dyspareunia.","OBJECTIVE The softgel 17β-estradiol (E2) vaginal inserts (4 and 10 μg; Imvexxy; TherapeuticsMD, Boca Raton, FL) are FDA approved for treating moderate to severe dyspareunia associated with postmenopausal vulvar and vaginal atrophy (VVA). The objective here was to determine responder rates at week 2 and whether week-2 findings predicted week-12 responders in the REJOICE trial. METHODS Postmenopausal women received E2 vaginal inserts 4, 10, or 25 μg, or placebo for 12 weeks. Proportion of responders (having ≥2 of the following: vaginal superficial cells >5%, vaginal pH <5.0, or dyspareunia improvement of ≥1 category) were calculated. Odds ratios (ORs) for positive response at week 12 given a positive response at week 2 were determined in the efficacy evaluable (EE) population. RESULTS The responder rate (in EE population [n = 695]) was 74% to 82% with E2 inserts versus 24% with placebo at week 2, and 72% to 80% versus 33% at week 12. Positive treatment responses were 9- to 14-fold higher with vaginal E2 than with placebo at week 2, and 5- to 8-fold higher at week 12. Response at week 2 predicted response at week 12 in the total population (OR 13.1; 95% CI, 8.8-19.7) and with active treatment only (OR 7.9; 95% CI, 4.7-13.2). CONCLUSIONS A high percentage of postmenopausal women with moderate to severe dyspareunia responded with the E2 softgel vaginal insert at week 2, and a positive response at week 2 predicted a positive response at week 12.",2019,"Positive treatment responses were 9- to 14-fold higher with vaginal E2 than with placebo at week 2, and 5- to 8-fold higher at week 12.","['Postmenopausal women received E2 vaginal inserts 4, 10, or 25\u200aμg, or', 'postmenopausal women with moderate to severe dyspareunia']","['placebo', 'softgel 17β-estradiol (E2) vaginal inserts (4 and 10\u200aμg; Imvexxy; TherapeuticsMD, Boca Raton, FL']","['Odds ratios (ORs) for positive response', 'responder rates', 'responder rate']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1719963', 'cui_str': 'Conventional release vaginal insert'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0013394', 'cui_str': 'Pain in female genitalia on intercourse (finding)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1700235', 'cui_str': '(11BAPOP2) estradiol'}, {'cui': 'C1719963', 'cui_str': 'Conventional release vaginal insert'}, {'cui': 'C4704162', 'cui_str': 'Imvexxy'}]","[{'cui': 'C0028873', 'cui_str': 'Risk Ratio'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}]",,0.173882,"Positive treatment responses were 9- to 14-fold higher with vaginal E2 than with placebo at week 2, and 5- to 8-fold higher at week 12.","[{'ForeName': 'Ginger', 'Initials': 'G', 'LastName': 'Constantine', 'Affiliation': 'EndoRheum Consultants, LLC, Malvern, PA.'}, {'ForeName': 'Leah S', 'Initials': 'LS', 'LastName': 'Millheiser', 'Affiliation': 'Stanford University School of Medicine, Stanford, CA.'}, {'ForeName': 'Andrew M', 'Initials': 'AM', 'LastName': 'Kaunitz', 'Affiliation': 'University of Florida College of Medicine-Jacksonville, Jacksonville, FL.'}, {'ForeName': 'Sharon J', 'Initials': 'SJ', 'LastName': 'Parish', 'Affiliation': 'Weill Cornell Medical College, New York, NY.'}, {'ForeName': 'Shelli', 'Initials': 'S', 'LastName': 'Graham', 'Affiliation': 'TherapeuticsMD, Boca Raton, FL.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Bernick', 'Affiliation': 'TherapeuticsMD, Boca Raton, FL.'}, {'ForeName': 'Sebastian', 'Initials': 'S', 'LastName': 'Mirkin', 'Affiliation': 'TherapeuticsMD, Boca Raton, FL.'}]","Menopause (New York, N.Y.)",['10.1097/GME.0000000000001394'] 3205,31688575,Improved periodontal disease and prevention of tooth loss in osteoporosis patients receiving once-yearly zoledronic acid: a randomized clinical trial.,"OBJECTIVE This randomized, clinical trial investigated whether zoledronic acid combined with oral health maintenance can improve periodontal disease associated with osteoporosis, thus reducing the risk of tooth loss. METHODS Participants were those of the ZONE (ZOledroNate treatment in efficacy to osteoporosis) study. None of the participants had symptomatic periodontal disease at baseline. Participants received either zoledronic acid (5 mg; n = 333 [male 21, female 312]) or placebo (n = 332 [male 19, female 313]) once yearly for 2 years, and their age was 74.0 ± 5.3 (65-88) and 74.3 ± 5.4 (65-87) years, respectively. Participants were instructed to maintain good oral hygiene at baseline and every 3 months. Participants with signs or symptoms involving their oral cavity at the monthly visit with their physician were referred to dentists for examination of oral disease. All cases were included to analyze adverse events in this study. Testing for significance was conducted using Fisher exact test (P < 0.05). RESULTS The incidence of oral adverse events was significantly higher in the control group (67 cases, 20.2%) than in the zoledronic acid group (47 cases, 14.1%; P = 0.04). The frequency of symptomatic periodontal disease observed during the study was significantly higher in the control group (40 cases, 12.0%) than in the zoledronic acid group (18 cases, 5.4%; P = 0.002). Loss of teeth was more frequent in the control group (36 cases, 10.8%) than in the zoledronic acid group (24 cases, 7.2%), although the difference was not significant. CONCLUSIONS Zoledronic acid effectively prevented symptomatic periodontal disease in patients with osteoporosis who maintained good oral hygiene. : Video Summary: Supplemental Digital Content 1, http://links.lww.com/MENO/A438.",2019,"Loss of teeth was more frequent in the control group (36 cases, 10.8%) than in the zoledronic acid group (24 cases, 7.2%), although the difference was not significant. ","['patients with osteoporosis who maintained good oral hygiene', 'Participants with signs or symptoms involving their oral cavity at the monthly visit with their physician were referred to dentists for examination of oral disease', 'osteoporosis patients receiving once-yearly', 'n\u200a=\u200a332 [male 19, female 313]) once yearly for 2 years, and their age was 74.0\u200a±\u200a5.3 (65-88) and 74.3\u200a±\u200a5.4 (65-87) years, respectively', '5\u200amg; n\u200a=\u200a333 [male 21, female 312]) or', 'Participants were those of the']","['ZONE (ZOledroNate treatment', 'placebo', 'Zoledronic acid', 'zoledronic acid combined with oral health maintenance', 'zoledronic acid', ' Video Summary: Supplemental Digital Content 1, http://links.lww.com/MENO/A438']","['incidence of oral adverse events', 'symptomatic periodontal disease', 'frequency of symptomatic periodontal disease', 'periodontal disease and prevention of tooth loss', 'Loss of teeth']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0029456', 'cui_str': 'Osteoporosis'}, {'cui': 'C1314677', 'cui_str': 'Maintained'}, {'cui': 'C0457639', 'cui_str': 'Good oral hygiene (finding)'}, {'cui': 'C0311392', 'cui_str': 'Sign'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C0226896', 'cui_str': 'Cavitas Oris'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C0420354', 'cui_str': 'Referred to dentist (finding)'}, {'cui': 'C1273867', 'cui_str': 'Examination (heading)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C4517707', 'cui_str': '313'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C4708663', 'cui_str': '5.3'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C4517792', 'cui_str': 'Five point four'}, {'cui': 'C4517724', 'cui_str': 'Three hundred and thirty-three'}, {'cui': 'C4517706', 'cui_str': '312 (qualifier value)'}]","[{'cui': 'C0392938', 'cui_str': 'Zoledronate (substance)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0257685', 'cui_str': 'zoledronic acid'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0150289', 'cui_str': 'Oral health maintenance'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray (qualifier value)'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0231220', 'cui_str': 'Symptomatic (qualifier value)'}, {'cui': 'C0031090', 'cui_str': 'Parodontosis'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0080233', 'cui_str': 'Tooth Loss'}]",,0.0557918,"Loss of teeth was more frequent in the control group (36 cases, 10.8%) than in the zoledronic acid group (24 cases, 7.2%), although the difference was not significant. ","[{'ForeName': 'Akira', 'Initials': 'A', 'LastName': 'Taguchi', 'Affiliation': 'Department of Oral and Maxillofacial Radiology, Matsumoto Dental University, Nagano, Japan.'}, {'ForeName': 'Masataka', 'Initials': 'M', 'LastName': 'Shiraki', 'Affiliation': 'Research Institute and Practice for Involutional Diseases, Nagano, Japan.'}, {'ForeName': 'Satoshi', 'Initials': 'S', 'LastName': 'Tanaka', 'Affiliation': 'Asahi Kasei Pharma Corporation, Tokyo, Japan.'}, {'ForeName': 'Hideyo', 'Initials': 'H', 'LastName': 'Ohshige', 'Affiliation': 'Asahi Kasei Pharma Corporation, Tokyo, Japan.'}, {'ForeName': 'Toshitaka', 'Initials': 'T', 'LastName': 'Nakamura', 'Affiliation': 'Touto Sangenjaya Rehabilitation Hospital, Tokyo, Japan.'}]","Menopause (New York, N.Y.)",['10.1097/GME.0000000000001393'] 3206,31926466,How well can a large number of polysomnography sleep measures predict subjective sleep quality in insomnia patients?,"OBJECTIVE The determinants of sleep quality (sQUAL) are poorly understood. We evaluated how well a large number of objective polysomnography (PSG) parameters can predict sQUAL in insomnia patients participating in trials of sleep medications or placebo. METHODS PSG recordings over multiple nights from two clinical drug development programs involving 1158 insomnia patients treated with suvorexant or placebo and 903 insomnia patients treated with gaboxadol or placebo were used post-hoc to analyze univariate and multivariate associations between sQUAL and 98 PSG sleep parameters plus patient's age and gender. Analyses were performed separately for each of the two clinical trial databases. For univariate associations, within-subject correlations were estimated using mixed effect modeling of bi-variate longitudinal data with one variable being a given PSG variable and the other being sQUAL. To evaluate how accurately sQUAL could be predicted by all PSG variables jointly plus patient's age and gender, the Random Forest multivariate technique was used. Random Forest was also used to evaluate the accuracy of sQUAL prediction by subjective sleep measures plus age and gender, and to quantitatively describe the relative importance of each variable for predicting sQUAL. RESULTS In the univariate analyses, total sleep time (TST) had the largest correlation with sQUAL compared with all other PSG sleep parameters, and the magnitude of the correlation between each PSG sleep architecture parameter and sQUAL generally increased with the strength of their associations with TST. In the multivariate analyses, the overall accuracy of sQUAL prediction, even with the large number of PSG parameters plus patient's age and gender, was moderate (area under the Receiver Operating Characteristic curve (AROC): 71.2-71.8%). Ranking of PSG parameters by their contribution to sQUAL indicated that TST was the most important predictor of sQUAL among all PSG variables. Subjective TST and subjective number of awakenings jointly with patient's age classified sQUAL with higher accuracy (AROC: 78.7-81.7%) than PSG variables plus age and gender. The pattern of findings was consistent across the two clinical trial databases. CONCLUSION In insomnia patients participating in trials of sleep medications or placebo, PSG variables had a moderate but consistent pattern of association with sQUAL across two separate clinical trial databases. Of the PSG variables evaluated, TST was the best predictor of sQUAL. CLINICAL TRIALS: trial registration at www.clinicaltrials.gov: NCT01097616; NCT01097629; NCT00094627; NCT00094666.",2020,"In the univariate analyses, total sleep time (TST) had the largest correlation with sQUAL compared with all other PSG sleep parameters, and the magnitude of the correlation between each PSG sleep architecture parameter and sQUAL generally increased with the strength of their associations with TST.","['insomnia patients', 'and 903 insomnia patients treated with', 'insomnia patients participating in trials of sleep medications or', 'PSG recordings over multiple nights from two clinical drug development programs involving 1158 insomnia patients treated with', 'insomnia patients participating in trials of sleep medications or placebo']","['placebo', 'suvorexant or placebo', 'gaboxadol or placebo']","['total sleep time (TST', 'Subjective TST and subjective number of awakenings']","[{'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0872152', 'cui_str': 'Medication Development'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C1314939', 'cui_str': 'Involvement (attribute)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3179535', 'cui_str': 'suvorexant'}, {'cui': 'C0047845', 'cui_str': '4,5,6,7-tetrahydroisoxazolo(5,4-c)pyridin-3-ol'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1720052', 'cui_str': 'Awakening'}]",1158.0,0.0873198,"In the univariate analyses, total sleep time (TST) had the largest correlation with sQUAL compared with all other PSG sleep parameters, and the magnitude of the correlation between each PSG sleep architecture parameter and sQUAL generally increased with the strength of their associations with TST.","[{'ForeName': 'Vladimir', 'Initials': 'V', 'LastName': 'Svetnik', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA. Electronic address: vladimir.svetnik@merck.com.'}, {'ForeName': 'Ellen S', 'Initials': 'ES', 'LastName': 'Snyder', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'Peining', 'Initials': 'P', 'LastName': 'Tao', 'Affiliation': 'Wellinfo Consulting, LLC, Edison, NJ, USA.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Roth', 'Affiliation': 'Henry Ford Hospital Sleep Center, Detroit, MI, USA.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Lines', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA.'}, {'ForeName': 'W Joseph', 'Initials': 'WJ', 'LastName': 'Herring', 'Affiliation': 'Merck & Co., Inc., Kenilworth, NJ, USA.'}]",Sleep medicine,['10.1016/j.sleep.2019.08.020'] 3207,31993664,Compliance in controlled e-cigarette studies.,"INTRODUCTION E-cigarette studies have found that use of a variety of flavors and customizable devices results in greater use frequency and user satisfaction. However, standardized research e-cigarettes are being developed as closed systems with limited flavor options, potentially limiting user satisfaction. In this study, we explore protocol compliance in an e-cigarette study using a standardized, assigned device with puff time and duration tracking (controlled e-cigarette) and potential limitations that controlled devices and e-liquids can introduce. METHODS In a crossover study forty-nine young adult e-cigarette users were recruited using convenience sampling and assigned a controlled e-cigarette device and flavored or unflavored e-liquids on standardized protocols. E-cigarette use frequency (number of puffs per day, collected from the device) and serum cotinine levels were obtained at each of 3 study visits over three weeks. The correlation of cotinine and e-cigarette use over the preceding week was calculated at each study visit. RESULTS Correlation of nicotine intake, as measured by serum cotinine, and puff time, as measured by puffs count and duration from the e-cigarette device, as an indicator of study protocol compliance, substantially declined after the first week of the study and were no longer correlated in the remaining study weeks (R2=0.53 and p≤0.01 in week 1, R2<0.5 and p>0.05 for remaining weeks). CONCLUSIONS There is an emerging need for controlled e-cigarette exposures studies, but low compliance in use of assigned devices and e-liquids may be a limitation that needs to be mitigated in future studies.",2020,"RESULTS Correlation of nicotine intake, as measured by serum cotinine, and puff time, as measured by puffs count and duration from the e-cigarette device, as an indicator of study protocol compliance, substantially declined after the first week of the study and were no longer correlated in the remaining study weeks (",['forty-nine young adult e-cigarette users'],['convenience sampling and assigned a controlled e-cigarette device and flavored or unflavored e-liquids on standardized protocols'],"['serum cotinine levels', 'serum cotinine, and puff time, as measured by puffs count and duration from the e-cigarette device']","[{'cui': 'C0238598', 'cui_str': 'Young Adult'}, {'cui': 'C4087159', 'cui_str': 'Electronic cigarette user (finding)'}]","[{'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C3849993', 'cui_str': 'Electronic Cigarettes'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C4543628', 'cui_str': 'Electronic cigarette liquid (physical object)'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0010194', 'cui_str': 'Scotine'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C1533107', 'cui_str': 'Puffs'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0439157', 'cui_str': 'counts (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C3849993', 'cui_str': 'Electronic Cigarettes'}, {'cui': 'C0220819', 'cui_str': 'devices'}]",49.0,0.0258947,"RESULTS Correlation of nicotine intake, as measured by serum cotinine, and puff time, as measured by puffs count and duration from the e-cigarette device, as an indicator of study protocol compliance, substantially declined after the first week of the study and were no longer correlated in the remaining study weeks (","[{'ForeName': 'Meghan E', 'Initials': 'ME', 'LastName': 'Rebuli', 'Affiliation': 'Curriculum in Toxicology & Environmental Medicine, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.'}, {'ForeName': 'Feifei', 'Initials': 'F', 'LastName': 'Liu', 'Affiliation': 'Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles, California, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Urman', 'Affiliation': 'Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles, California, USA.'}, {'ForeName': 'Jessica L', 'Initials': 'JL', 'LastName': 'Barrington-Trimis', 'Affiliation': 'Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles, California, USA.'}, {'ForeName': 'Sandrah P', 'Initials': 'SP', 'LastName': 'Eckel', 'Affiliation': 'Division of Biostatistics, Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA.'}, {'ForeName': 'Rob', 'Initials': 'R', 'LastName': 'McConnell', 'Affiliation': 'Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles, California, USA.'}, {'ForeName': 'Ilona', 'Initials': 'I', 'LastName': 'Jaspers', 'Affiliation': 'Curriculum in Toxicology & Environmental Medicine, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina, USA.'}]",Nicotine & tobacco research : official journal of the Society for Research on Nicotine and Tobacco,['10.1093/ntr/ntaa017'] 3208,31996580,Functional Outcome and Sexual-Related Quality of Life After Transperineal Versus Transvaginal Repair of Anterior Rectocele: A Randomized Clinical Trial.,"BACKGROUND Methods of treatment of rectocele include transperineal, transvaginal, and transanal approaches and ventral rectopexy. OBJECTIVE The present randomized study aimed to compare the outcome of transperineal repair and transvaginal repair of anterior rectocele. DESIGN This is a randomized, single-blinded clinical trial. SETTING This study was conducted at the Colorectal Surgery Unit, Mansoura University Hospitals. PATIENTS Adult female patients with anterior rectocele reporting obstructed defecation syndrome were selected. INTERVENTIONS Anterior rectocele was surgically treated via a transperineal or transvaginal approach. MAIN OUTCOME MEASURES Improvement in constipation, operation time, hospital stay, complications, changes in anal pressures, and improvement in sexual-related quality of life was assessed by use of the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire, and the incidence of dyspareunia postoperatively was assessed. RESULTS Sixty-four female patients of a mean age of 43.5 years were entered into the trial. There was no significant difference between the 2 groups regarding the operation time. Patients undergoing transperineal repair had significantly longer hospital stays than those undergoing transvaginal repair (2.4 vs 2.1 days, p = 0.03). There was no significant difference between the 2 groups regarding postoperative complications and recurrence of rectocele. Significant decrease in the constipation scores was recorded in both groups at 6 and 12 months after surgery. The decrease in the constipation scores after transvaginal repair was significantly higher than after transperineal repair at 6 and 12 months postoperatively. Although resting and squeeze anal pressures were significantly increased at 12 months after transperineal repair, they did not show significant change after transvaginal repair. Improvement in sexual-related quality of life was significantly higher in the transvaginal repair group than in the transperineal repair group at 6 and 12 months after surgery. Dyspareunia improved after transvaginal repair and worsened after transperineal repair, yet this change was insignificant. LIMITATIONS This was a single-center study comprising a relatively small number of patients. CONCLUSION Transvaginal repair of rectocele achieved better improvement in constipation and sexual-related quality of life than transperineal repair. Changes in dyspareunia after both techniques were not significant. See Video Abstract at http://links.lww.com/DCR/B148. CLINICAL TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT03801291. RESULTADO FUNCIONAL Y CALIDAD DE VIDA RELACIONADA CON EL SEXO DESPUÉS DE LA REPARACIÓN TRANSPERINEAL VERSUS TRANSVAGINAL DEL RECTOCELE ANTERIOR: UN ENSAYO CLÍNICO ALEATORIZADO: Los métodos de tratamiento del rectocele incluyen los abordajes transperineal, transvaginal y transanal y la rectopexia ventral.El objetivo del presente estudio aleatorizado fue comparar el resultado de la reparación transperineal y la reparación transvaginal del rectocele anterior.Ensayo clínico aleatorizado, simple ciego.Unidad de Cirugía Colorrectal, Hospital Universitario de Mansoura.Pacientes mujeres adultas con rectocele anterior que se quejan de síndrome de defecación obstruida.Tratamiento quirúrgico del rectocele anterior mediante abordaje transperineal o transvaginal.Mejora en el estreñimiento, tiempo de operación, estancia hospitalaria, complicaciones, cambios en la presión anal, mejoría en la calidad de vida relacionada con el sexo evaluada por el cuestionario PISQ-12 e incidencia de dispareunia postoperatoria.Sesenta y cuatro pacientes de sexo femenino de una edad media de 43.5 años ingresaron al ensayo. No hubo diferencias significativas entre los dos grupos con respecto al tiempo de operación. La reparación transperineal tuvo una estancia hospitalaria significativamente más prolongada que la reparación transvaginal (2.4 Vs 2.1 días, p = 0.03). No hubo diferencias significativas entre ambos grupos con respecto a las complicaciones postoperatorias y la recurrencia del rectocele. Se registró una disminución significativa en las puntuaciones de estreñimiento en ambos grupos a los 6 y 12 meses después de la cirugía. La disminución en las puntuaciones de estreñimiento después de la reparación transvaginal fue significativamente mayor que después de la reparación transperineal a los 6 y 12 meses después de la operación. Aunque las presiones anales de reposo y compresión aumentaron significativamente a los 12 meses después de la reparación transperineal, no mostraron cambios significativos después de la reparación transvaginal. La mejora en la calidad de vida relacionada con el sexo fue significativamente mayor en la reparación transvaginal que en el grupo de reparación transperineal a los 6 y 12 meses después de la cirugía. La dispareunia mejoró después de la reparación transvaginal y empeoró después de la reparación transperineal, sin embargo, este cambio fue insignificante.Estudio de un solo centro que comprende un número relativamente pequeño de pacientes.La reparación transvaginal del rectocele logró una mejoría en el estreñimiento y la calidad de vida relacionada con el sexo que la reparación transperineal. Los cambios en la dispareunia después de ambas técnicas no fueron significativos. Consulte Video Resumen en http://links.lww.com/DCR/B148.Ensayos clínicos. Identificador del gobierno: NCT03801291.",2020,Improvement in sexual-related quality of life was significantly higher in the transvaginal repair than the transperineal repair group at 6 and 12 months after surgery.,"['Colorectal Surgery Unit, Mansoura University Hospitals', 'Adult female patients with anterior rectocele complaining of obstructed defecation syndrome', 'Single center study comprising relatively small number of patients', 'Sixty-four female patients of a mean age of 43.5 years']","['transperineal repair and transvaginal repair of anterior rectocele', 'Transperineal versus Transvaginal Repair of Anterior Rectocele', 'anterior rectocele via transperineal or transvaginal approach']","['constipation, operation time, hospital stay, complications, changes in anal pressures, improvement in sexual-related quality of life assessed by the PISQ-12 questionnaire, and incidence of dyspareunia postoperatively', 'constipation scores', 'operation time', 'Functional outcome and Sexual-Related Quality of Life', 'sexual-related quality of life', 'resting and squeeze anal pressures', 'postoperative complications and recurrence of rectocele', 'constipation and sexual-related quality of life', 'dyspareunia', 'longer hospital stay', 'Dyspareunia']","[{'cui': 'C0009369', 'cui_str': 'Colon and Rectal Surgery Specialty'}, {'cui': 'C0439148', 'cui_str': 'Units (attribute)'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C0149771', 'cui_str': 'Proctocele'}, {'cui': 'C0549186', 'cui_str': 'Obstructed (qualifier value)'}, {'cui': 'C0011135', 'cui_str': 'Defecation'}, {'cui': 'C0039082', 'cui_str': 'Symptom Cluster'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C4517839', 'cui_str': '64'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0205500', 'cui_str': 'Perineal approach (qualifier value)'}, {'cui': 'C0374711', 'cui_str': 'Surgical repair (procedure)'}, {'cui': 'C0175672', 'cui_str': 'Vaginal approach (qualifier value)'}, {'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C0149771', 'cui_str': 'Proctocele'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}]","[{'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0038895', 'cui_str': 'operative therapy'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C2939124', 'cui_str': 'Anal (qualifier value)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0034380'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0013394', 'cui_str': 'Pain in female genitalia on intercourse (finding)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0035253', 'cui_str': 'Rest'}, {'cui': 'C0413258', 'cui_str': 'Barotrauma of descent (disorder)'}, {'cui': 'C0032787', 'cui_str': 'Postoperative Complications'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0149771', 'cui_str': 'Proctocele'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}]",64.0,0.0437358,Improvement in sexual-related quality of life was significantly higher in the transvaginal repair than the transperineal repair group at 6 and 12 months after surgery.,"[{'ForeName': 'Mohammed', 'Initials': 'M', 'LastName': 'Balata', 'Affiliation': 'Colorectal Surgery Unit, Department of General Surgery, Mansoura University Hospitals, Mansoura University, Egypt.'}, {'ForeName': 'Hesham', 'Initials': 'H', 'LastName': 'Elgendy', 'Affiliation': ''}, {'ForeName': 'Sameh Hany', 'Initials': 'SH', 'LastName': 'Emile', 'Affiliation': ''}, {'ForeName': 'Mohamed', 'Initials': 'M', 'LastName': 'Youssef', 'Affiliation': ''}, {'ForeName': 'Waleed', 'Initials': 'W', 'LastName': 'Omar', 'Affiliation': ''}, {'ForeName': 'Wael', 'Initials': 'W', 'LastName': 'Khafagy', 'Affiliation': ''}]",Diseases of the colon and rectum,['10.1097/DCR.0000000000001595'] 3209,31997369,Patients' interpersonal problems as moderators of depression outcomes in a randomized controlled trial comparing mindfulness-based cognitive therapy and a group version of the cognitive-behavioral analysis system of psychotherapy in chronic depression.,"OBJECTIVES Interpersonal problems were examined as moderators of depression outcomes between mindfulness-based cognitive therapy (MBCT) and cognitive behavioral analysis system of psychotherapy (CBASP) in patients with chronic depression. METHODS Patients received treatment-as-usual and, in addition, were randomized to 8-weeks of MBCT (n = 34) or 8-weeks of CBASP (n = 34). MBCT and CBASP were given in a group format. The Hamilton depression rating scale (HAM-D) was the primary and the Beck Depression Inventory (BDI-II) the secondary outcome. The subscales of the Inventory of interpersonal problems (IIP-32) were moderators. Multilevel models were performed. RESULTS Higher scores on the ""vindictive/self-centered"" subscale were associated with a better outcome in MBCT than in CBASP (HAM-D: p < .01; BDI-II: p < .01). Higher scores on the ""nonassertive"" subscale were associated with a better outcome in CBASP than in MBCT (HAM-D: p < .01; BDI-II: p < .01). CONCLUSIONS If these results can be replicated in larger trials, MBCT should be preferred to CBASP in chronically depressed patients being vindictive/self-centered, whereas CBASP should be preferred to MBCT in chronically depressed patients being nonassertive.",2020,"Higher scores on the ""nonassertive"" subscale were associated with a better outcome in CBASP than in MBCT (HAM-D: p < .01; BDI-II: p < .01). ","['Patients received treatment-as-usual and, in addition', 'chronic depression', 'patients with chronic depression']","['CBASP', 'mindfulness-based cognitive therapy (MBCT) and cognitive behavioral analysis system of psychotherapy (CBASP', 'MBCT and CBASP', 'mindfulness-based cognitive therapy and a group version of the cognitive-behavioral analysis system of psychotherapy', 'MBCT']","['nonassertive"" subscale', 'vindictive/self-centered"" subscale', 'Hamilton depression rating scale (HAM-D']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0581391', 'cui_str': 'Chronic depression (disorder)'}]","[{'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C1160858', 'cui_str': 'Behavior care assessment'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C1273567', 'cui_str': 'Psychotherapy (specialty)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C2607870', 'cui_str': 'Version (morphologic abnormality)'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0222045'}, {'cui': 'C3853311', 'cui_str': 'Ham'}]",,0.0194586,"Higher scores on the ""nonassertive"" subscale were associated with a better outcome in CBASP than in MBCT (HAM-D: p < .01; BDI-II: p < .01). ","[{'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Probst', 'Affiliation': 'Department for Psychotherapy and Biopsychosocial Health, Danube University Krems, Krems an der Donau, Austria.'}, {'ForeName': 'Elisabeth', 'Initials': 'E', 'LastName': 'Schramm', 'Affiliation': 'Department of Psychiatry and Psychotherapy, Medical Center, Faculty of Medicine, University of Freiburg, Freiburg im Breisgau, Germany.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Heidenreich', 'Affiliation': 'Faculty Social Work, Health, and Nursing, Esslingen University of Applied Sciences, Esslingen am Neckar, Germany.'}, {'ForeName': 'Jan-Philipp', 'Initials': 'JP', 'LastName': 'Klein', 'Affiliation': 'Department of Psychiatry and Psychotherapy, University of Lübeck, Lübeck, Germany.'}, {'ForeName': 'Johannes', 'Initials': 'J', 'LastName': 'Michalak', 'Affiliation': 'Department of Psychology and Psychotherapy, Witten/Herdecke University, Witten, Germany.'}]",Journal of clinical psychology,['10.1002/jclp.22931'] 3210,31992372,Flaxseed oil in the context of a weight loss programme ameliorates fatty liver grade in patients with non-alcoholic fatty liver disease: a randomised double-blind controlled trial.,"Long-chain n-3 fatty acids have been shown to regulate lipid metabolism and reduce fat accumulation in the liver. This trial investigated the effect of flaxseed oil, as a rich source of α-linolenic acid, on fatty liver and cardiometabolic risk factors in patients with non-alcoholic fatty liver disease (NAFLD). The randomised, double-blind, controlled trial was performed on sixty-eight NAFLD patients who were divided into flaxseed (n 34) and sunflower (n 34) oil groups. Patients were given a hypoenergetic diet (-2092 kJ/d) and 20 g/d of the corresponding oil for 12 weeks. Fatty liver grade, liver enzymes and cardiometabolic parameters were determined. The intention-to-treat approach was used for data analysis. Fatty liver grade significantly decreased in both groups (-0·68 in flaxseed v. -0·29 in sunflower, P = 0·002). Alanine aminotransferase and aspartate aminotransferase decreased in both groups (P < 0·01). Also, significant reduction was observed in blood glucose (P = 0·005) and fat mass (P = 0·01) in the flaxseed and muscle mass (P = 0·01) in the sunflower group. However, none of these alterations was significantly different between the groups. Weight, waist circumference and blood pressure were significantly decreased in both groups but only weight change was significantly different between the groups (P = 0·01). IL-6 did not significantly change in either group but showed a significant between-group difference (P = 0·03). Overall, the results showed that in the context of a low-energy diet and moderate physical activity, flaxseed oil may benefit NAFLD patients to improve fatty liver grade, weight and IL-6 compared with sunflower oil.",2020,"Fatty liver grade significantly decreased in both groups (-0.68 in flaxseed vs. -0.29 in sunflower, P=0.002).","['patients with non-alcoholic fatty liver disease (NAFLD', '68 NAFLD patients who divided into flaxseed (n=34) and sunflower (n=34) oil groups', 'patients with non-alcoholic fatty liver disease']","['Long-chain omega-3 fatty acids', 'flaxseed oil', 'Flaxseed oil', 'hypocaloric diet']","['Interleukin-6', 'fatty liver grade, weight, and interleukin-6', 'blood glucose', 'Fatty liver grade', 'Weight, waist circumference, and blood pressure', 'weight change', 'ALT and AST', 'Fatty liver grade, liver enzymes, and cardiometabolic parameters', 'fat mass']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0400966', 'cui_str': 'NAFLD'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0023753', 'cui_str': 'Flaxseed'}, {'cui': 'C0028908', 'cui_str': 'Oils'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C0337112', 'cui_str': 'Chain, device (physical object)'}, {'cui': 'C0015689', 'cui_str': 'Omega-3 Fatty Acids'}, {'cui': 'C0023754', 'cui_str': 'flaxseed oil'}, {'cui': 'C0012155', 'cui_str': 'Diet'}]","[{'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0015695', 'cui_str': 'Fatty Liver'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0005911', 'cui_str': 'Body Weight Changes'}, {'cui': 'C0443764', 'cui_str': 'Liver enzyme (substance)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}]",68.0,0.124052,"Fatty liver grade significantly decreased in both groups (-0.68 in flaxseed vs. -0.29 in sunflower, P=0.002).","[{'ForeName': 'Shahla', 'Initials': 'S', 'LastName': 'Rezaei', 'Affiliation': 'Department of Clinical Nutrition, School of Nutrition and Food Sciences, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Mohammad Reza', 'Initials': 'MR', 'LastName': 'Sasani', 'Affiliation': 'Medical Imaging Research Center, Department of Radiology, School of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Masoumeh', 'Initials': 'M', 'LastName': 'Akhlaghi', 'Affiliation': 'Nutrition Research Center, School of Nutrition and Food Sciences, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Ali', 'Initials': 'A', 'LastName': 'Kohanmoo', 'Affiliation': 'Nutrition Research Center, School of Nutrition and Food Sciences, Shiraz University of Medical Sciences, Shiraz, Iran.'}]",The British journal of nutrition,['10.1017/S0007114520000318'] 3211,31999360,The Base Rate Study: Developing Base Rates for Risk Factors and Indicators for Engagement in Violent Extremism.,"Improvements have been made in identifying the prevalence of risk factors/indicators for violent extremism. A consistent problem is the lack of base rates. How to develop base rates is of equal concern. This study has two aims: (i) compare two methods for developing base rates; the Unmatched Count Technique (UCT) and direct questioning, (ii) generate base rates in a general population sample and compare these to a sample of lone-actor terrorists (n = 125). We surveyed 2108 subjects from the general population. Participants were recruited from an online access panel and randomly assigned to one of three conditions; direct survey, control, or UCT. Survey items were based on a lone-actor terrorist codebook developed from the wider literature. Direct questioning was more suitable under our study conditions where UCT resulted in deflation effects. Comparing the base rates identified a number of significant differences: (i) lone-actor terrorists demonstrated propensity indicators related to a cognitive susceptibility, and a crime- and/or violence-supportive morality more often; the general sample demonstrated protective factors more often, (ii) lone-actor terrorists demonstrated situational indicators related to a crime- and/or violence-supportive morality more often, whereas the general sample experienced situational stressors more often, (iii) lone-actor terrorists demonstrated indicators related to exposure to extremism more often. Results suggest there are measurable differences in the prevalence of risk factors between lone-actor terrorists and the general population. However, no single factor ""predicts"" violent extremism. This bears implications for our understanding of the interrelation of risk and protective factors, and for the risk assessment of violent extremism.",2020,Results suggest there are measurable differences in the prevalence of risk factors between lone-actor terrorists and the general population.,['2108 subjects from the general population'],"['direct survey, control, or UCT']",['deflation effects'],"[{'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}]",2108.0,0.0480416,Results suggest there are measurable differences in the prevalence of risk factors between lone-actor terrorists and the general population.,"[{'ForeName': 'Caitlin', 'Initials': 'C', 'LastName': 'Clemmow', 'Affiliation': 'Department of Security and Crime Science, University College London, London, U.K.'}, {'ForeName': 'Sandy', 'Initials': 'S', 'LastName': 'Schumann', 'Affiliation': 'Department of Security and Crime Science, University College London, London, U.K.'}, {'ForeName': 'Nadine L', 'Initials': 'NL', 'LastName': 'Salman', 'Affiliation': 'Department of Security and Crime Science, University College London, London, U.K.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Gill', 'Affiliation': 'Department of Security and Crime Science, University College London, London, U.K.'}]",Journal of forensic sciences,['10.1111/1556-4029.14282'] 3212,31848294,"A Randomized Trial Comparing the Safety, Adherence, and Pharmacodynamics Profiles of Two Doses of Sodium Bicarbonate in CKD: the BASE Pilot Trial.","BACKGROUND Oral sodium bicarbonate (NaHCO 3 ) may preserve kidney function in CKD, even if initiated when serum bicarbonate concentration is normal. Adequately powered trials testing this hypothesis have not been conducted, partly because the best dose for testing is unknown. METHODS This multicenter pilot trial assessed the safety, tolerability, adherence, and pharmacodynamics of two doses of NaHCO 3 over 28 weeks in adults with eGFR 20-44 or 45-59 ml/min per 1.73 m 2 with urinary albumin/creatinine (ACR) ≥50 mg/g and serum bicarbonate 20-28 meq/L. We randomly assigned 194 participants from ten clinical sites to receive higher-dose (HD-NaHCO 3 ; 0.8 meq/kg of lean body wt per day; n =90) or lower-dose (LD-NaHCO 3 ; 0.5 meq/kg of lean body wt per day; n =52) NaHCO 3 or matching placebo ( n =52). The dose was adjusted depending on side effects. The prescribed dose at week 28 was the primary outcome; a dose was considered acceptable for a full-scale trial if ≥67% of participants were on full-dose and ≥80% were on ≥25% of the per-protocol dose. RESULTS Mean±SD baseline eGFR was 36±9 ml/min per 1.73 m 2 , serum bicarbonate was 24±2 meq/L, and median (IQR) ACR was 181 (25-745) mg/g. Both doses were well tolerated without significant changes in BP, weight, or serum potassium. The proportions of adverse events and hospitalizations were similar across the groups. Consequently, 87% in HD-NaHCO 3 , 96% in LD-NaHCO 3 , and 87% in placebo were on full dose at week 28; and 91% in HD-NaHCO 3 , 98% in LD-NaHCO 3 , and 92% in placebo were on ≥25% of the per-protocol dose. Mean urinary ammonium excretion was 25% lower and serum bicarbonate concentration was 1.3 meq/L higher in HD-NaHCO 3 compared with LD-NaHCO 3 at week 28. However, mean ACR increased by 12% in the lower-dose group and 30% in the higher-dose group. CONCLUSIONS Both NaHCO 3 doses were well tolerated over 28 weeks with no significant difference in adverse events or hospitalization compared with placebo. The higher dose lowered urinary ammonium excretion and increased serum bicarbonate more than the lower dose but was associated with a greater increase in ACR. The higher 0.8 meq/kg of lean body wt per day dose of NaHCO 3 may be a reasonable choice for future trials.",2020,The higher dose lowered urinary ammonium excretion and increased serum bicarbonate more than the lower dose but was associated with a greater increase in ACR.,"['194 participants from ten clinical sites to receive', 'CKD', 'adults with eGFR 20-44 or 45-59 ml/min per 1.73 m 2 with urinary albumin/creatinine (ACR) ≥50 mg/g and serum bicarbonate 20-28 meq']","['ACR', 'NaHCO', 'placebo', 'sodium bicarbonate (NaHCO 3 ', 'higher-dose (HD-NaHCO 3 ; 0.8 meq/kg of lean body wt per day; n =90) or lower-dose (LD-NaHCO 3 ; 0.5 meq/kg of lean body wt per day; n =52', 'NaHCO 3 or matching placebo', 'Sodium Bicarbonate']","['serum bicarbonate', 'median (IQR', 'Mean urinary ammonium excretion', 'adverse events or hospitalization', 'proportions of adverse events and hospitalizations', 'ACR', 'urinary ammonium excretion', 'serum bicarbonate concentration', 'safety, tolerability, adherence, and pharmacodynamics', 'mean ACR', 'BP, weight, or serum potassium']","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439445', 'cui_str': 'mL/min'}, {'cui': 'C3711292', 'cui_str': '68Ga-albumin'}, {'cui': 'C0010294', 'cui_str': 'Creatinine'}, {'cui': 'C1300563', 'cui_str': 'ug/mg'}, {'cui': 'C0428301', 'cui_str': 'Serum bicarbonate measurement'}, {'cui': 'C0439152', 'cui_str': 'milliequivalent'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0074722', 'cui_str': 'Sodium Bicarbonate'}, {'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}, {'cui': 'C4517481', 'cui_str': '0.8'}, {'cui': 'C1300572', 'cui_str': 'mEq/kg'}, {'cui': 'C0439505', 'cui_str': 'per day'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C0336766', 'cui_str': 'Matches'}]","[{'cui': 'C0428301', 'cui_str': 'Serum bicarbonate measurement'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0002611', 'cui_str': 'Ammonium'}, {'cui': 'C0221102', 'cui_str': 'Excretory function (observable entity)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0302353', 'cui_str': 'Serum potassium measurement'}]",194.0,0.50479,The higher dose lowered urinary ammonium excretion and increased serum bicarbonate more than the lower dose but was associated with a greater increase in ACR.,"[{'ForeName': 'Kalani L', 'Initials': 'KL', 'LastName': 'Raphael', 'Affiliation': 'Department of Internal Medicine, University of Utah Health and Renal Section, Veterans Affairs Salt Lake City Health Care System, Salt Lake City, Utah; kalani.raphael@hsc.utah.edu.'}, {'ForeName': 'Tamara', 'Initials': 'T', 'LastName': 'Isakova', 'Affiliation': 'Department of Medicine, Feinberg School of Medicine, Northwestern University, Chicago, Illinois.'}, {'ForeName': 'Joachim H', 'Initials': 'JH', 'LastName': 'Ix', 'Affiliation': 'Department of Medicine, University of California San Diego and Renal Section, Veterans Affairs San Diego Healthcare System, San Diego, California.'}, {'ForeName': 'Dominic S', 'Initials': 'DS', 'LastName': 'Raj', 'Affiliation': 'Division of Renal Diseases and Hypertension, Department of Medicine, George Washington University School of Medicine, Washington, DC.'}, {'ForeName': 'Myles', 'Initials': 'M', 'LastName': 'Wolf', 'Affiliation': 'Division of Nephrology, Department of Medicine, Duke Clinical Research Institute, Duke University, Durham, North Carolina.'}, {'ForeName': 'Linda F', 'Initials': 'LF', 'LastName': 'Fried', 'Affiliation': 'Department of Medicine, University of Pittsburgh and Renal Section, Veterans Affairs Pittsburgh Health Care System, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Jennifer J', 'Initials': 'JJ', 'LastName': 'Gassman', 'Affiliation': 'Department of Quantitative Health Sciences, Cleveland Clinic Foundation, Cleveland, Ohio.'}, {'ForeName': 'Cynthia', 'Initials': 'C', 'LastName': 'Kendrick', 'Affiliation': 'Department of Quantitative Health Sciences, Cleveland Clinic Foundation, Cleveland, Ohio.'}, {'ForeName': 'Brett', 'Initials': 'B', 'LastName': 'Larive', 'Affiliation': 'Department of Quantitative Health Sciences, Cleveland Clinic Foundation, Cleveland, Ohio.'}, {'ForeName': 'Michael F', 'Initials': 'MF', 'LastName': 'Flessner', 'Affiliation': 'Division of Kidney, Urologic, and Hematologic Diseases, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Susan R', 'Initials': 'SR', 'LastName': 'Mendley', 'Affiliation': 'Division of Kidney, Urologic, and Hematologic Diseases, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda, Maryland.'}, {'ForeName': 'Thomas H', 'Initials': 'TH', 'LastName': 'Hostetter', 'Affiliation': 'Department of Medicine, Case Western Reserve Hospitals, Cleveland, Ohio.'}, {'ForeName': 'Geoffrey A', 'Initials': 'GA', 'LastName': 'Block', 'Affiliation': 'Denver Nephrology, Denver, Colorado.'}, {'ForeName': 'Ping', 'Initials': 'P', 'LastName': 'Li', 'Affiliation': 'Renal Section, Veterans Affairs Washington, DC Health Care System, Washington, DC.'}, {'ForeName': 'John P', 'Initials': 'JP', 'LastName': 'Middleton', 'Affiliation': 'Division of Nephrology, Department of Medicine, Duke Clinical Research Institute, Duke University, Durham, North Carolina.'}, {'ForeName': 'Stuart M', 'Initials': 'SM', 'LastName': 'Sprague', 'Affiliation': 'Department of Medicine, Northshore University Health System, University of Chicago, Evanston, Illinois; and.'}, {'ForeName': 'Donald E', 'Initials': 'DE', 'LastName': 'Wesson', 'Affiliation': 'Health and Wellness Center, Baylor Scott & White Health, Dallas, Texas.'}, {'ForeName': 'Alfred K', 'Initials': 'AK', 'LastName': 'Cheung', 'Affiliation': 'Department of Internal Medicine, University of Utah Health and Renal Section, Veterans Affairs Salt Lake City Health Care System, Salt Lake City, Utah.'}]",Journal of the American Society of Nephrology : JASN,['10.1681/ASN.2019030287'] 3213,31850931,Mongersen (GED-0301) for Active Crohn's Disease: Results of a Phase 3 Study.,"INTRODUCTION The objective was to assess the efficacy and safety of GED-0301, an antisense oligodeoxynucleotide to Smad7, in active Crohn's disease (CD). METHODS This phase 3, blinded study randomized patients (1:1:1:1) to placebo or 1 of 3 once-daily oral GED-0301 regimens: 160 mg for 12 weeks followed by 40 mg continuously or alternating placebo with 40 or 160 mg every 4 weeks through week 52. RESULTS In all, 701 patients were randomized and received study medication before premature study termination; 78.6% (551/701) completed week 12, and 5.8% (41/701) completed week 52. The primary endpoint, clinical remission achievement (CD Activity Index score <150) at week 12, was attained in 22.8% of patients on GED-0301 vs 25% on placebo (P = 0.6210). At study termination, proportions of patients achieving clinical remission at week 52 were similar among individual GED-0301 groups and placebo. More placebo vs GED-0301 patients achieved endoscopic response (>50% decrease from baseline Simple Score for CD) at week 12 (18.1% vs 10.1%). Additional endoscopic endpoints were similar between groups at weeks 12 and 52. More placebo vs GED-0301 patients had clinical response (≥100-point decrease in the CD Activity Index score) at week 12 (44.4% vs 33.3%); at week 52, clinical response rates were similar. Adverse events were predominantly gastrointestinal and related to active CD, consistent with lack of clinical and endoscopic response to treatment. Two deaths occurred (GED-0301 total group) due to small intestinal obstruction and pneumonia; neither was suspected by the investigator to be treatment-related. DISCUSSION GED-0301 did not demonstrate efficacy vs placebo in active CD.",2020,"More placebo vs GED-0301 patients had clinical response (≥100-point decrease in the CD Activity Index score) at week 12 (44.4% vs 33.3%); at week 52, clinical response rates were similar.","[""active Crohn's disease (CD"", ""Active Crohn's Disease"", '701 patients']","['GED-0301', 'placebo']","['clinical response rates', 'Adverse events', 'endoscopic response', 'clinical remission', 'small intestinal obstruction and pneumonia', 'CD Activity Index score', 'clinical remission achievement (CD Activity Index score <150', 'clinical response']","[{'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0156147', 'cui_str': 'Colitis, Granulomatous'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0235329', 'cui_str': 'Small bowel obstruction (disorder)'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0001072', 'cui_str': 'Achievement'}, {'cui': 'C4321486', 'cui_str': '150 (qualifier value)'}]",701.0,0.409456,"More placebo vs GED-0301 patients had clinical response (≥100-point decrease in the CD Activity Index score) at week 12 (44.4% vs 33.3%); at week 52, clinical response rates were similar.","[{'ForeName': 'Bruce E', 'Initials': 'BE', 'LastName': 'Sands', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, New York, USA.'}, {'ForeName': 'Brian G', 'Initials': 'BG', 'LastName': 'Feagan', 'Affiliation': 'Robarts Clinical Trials and Western University, London, Ontario, Canada.'}, {'ForeName': 'William J', 'Initials': 'WJ', 'LastName': 'Sandborn', 'Affiliation': 'University of California San Diego, La Jolla, California, USA.'}, {'ForeName': 'Stefan', 'Initials': 'S', 'LastName': 'Schreiber', 'Affiliation': 'University Hospital Schleswig Holstein, Christian-Alrechts-University, Kiel, Germany.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Peyrin-Biroulet', 'Affiliation': 'Nancy University Hospital, Lorraine University, Inserm NGERE, Vandoeuvre lès Nancy, Nancy, France.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Frédéric Colombel', 'Affiliation': 'Icahn School of Medicine at Mount Sinai, New York, New York, USA.'}, {'ForeName': 'Guillermo', 'Initials': 'G', 'LastName': 'Rossiter', 'Affiliation': 'Celgene Corporation, Summit, New Jersey, USA.'}, {'ForeName': 'Keith', 'Initials': 'K', 'LastName': 'Usiskin', 'Affiliation': 'Celgene Corporation, Summit, New Jersey, USA.'}, {'ForeName': 'Shabana', 'Initials': 'S', 'LastName': 'Ather', 'Affiliation': 'Celgene Corporation, Summit, New Jersey, USA.'}, {'ForeName': 'Xiaojiang', 'Initials': 'X', 'LastName': 'Zhan', 'Affiliation': 'Celgene Corporation, Summit, New Jersey, USA.'}, {'ForeName': 'Geert', 'Initials': 'G', 'LastName': 'DʼHaens', 'Affiliation': 'University of Amsterdam, Amsterdam, the Netherlands.'}]",The American journal of gastroenterology,['10.14309/ajg.0000000000000493'] 3214,31221693,"Program ACTIVE II: Outcomes From a Randomized, Multistate Community-Based Depression Treatment for Rural and Urban Adults With Type 2 Diabetes.","OBJECTIVE Depression (major depressive disorder [MDD]) in adults with type 2 diabetes mellitus (T2DM) is associated with worsened diabetes complications, increased health care costs, and early mortality. Program ACTIVE II was a randomized, controlled, multicenter treatment trial designed to test the comparative effectiveness of cognitive behavioral therapy (CBT) and/or community-based exercise (EXER) on diabetes and depression outcomes compared with usual care (UC). RESEARCH DESIGN AND METHODS Using a 2 × 2 factorial randomized controlled trial design, adults with T2DM for ≥1 year who met DSM-IV-TR criteria for MDD were randomized to CBT (10 sessions occurring over 12 weeks; N = 36), EXER (12 weeks of community-based exercise including six sessions with a personal trainer; N = 34), CBT+EXER (concurrent over a 12-week period; N = 34), and UC ( N = 36). Primary outcomes were depression remission rate (assessed by psychiatric interviewers blind to assignment) and change in glycemic control (HbA 1c ). RESULTS The mean age was 56.0 years (SD 10.7). Participants were female (77%), white (71%), and married (52%). After controlling for education and antidepressant use, odds of achieving full MDD remission in the intervention groups were 5.0-6.8 times greater than UC ( P < 0.0167). The CBT+EXER group demonstrated improved HbA 1c compared with UC. For participants with a baseline HbA 1c ≥7.0%, exploratory post hoc subgroup analysis showed that the CBT+EXER group had a 1.1% improvement in HbA 1c ( P < 0.0001) after controlling for covariates. CONCLUSIONS The Program ACTIVE behavioral treatment interventions demonstrated clinically meaningful improvements in depression outcomes in adults with T2DM and MDD. These community-based interventions are complementary to medical care and extend access to those in rural and urban areas.",2019,"After controlling for education and antidepressant use, odds of achieving full MDD remission in the intervention groups were 5.0-6.8 times greater than UC ( P < 0.0167).","['The mean age was 56.0 years (SD 10.7', 'adults with type 2 diabetes mellitus (T2DM', 'adults with T2DM for ≥1 year who met DSM-IV-TR criteria for MDD', 'Rural and Urban Adults With Type 2 Diabetes', 'adults with T2DM and MDD', 'Participants were female (77%), white (71%), and married (52']","['Multistate Community-Based Depression Treatment', 'EXER (12 weeks of community-based exercise including six sessions with a personal trainer; N = 34), CBT+EXER', 'CBT', 'usual care (UC', 'cognitive behavioral therapy (CBT) and/or community-based exercise (EXER']","['diabetes and depression outcomes', 'depression outcomes', 'full MDD remission', 'depression remission rate (assessed by psychiatric interviewers blind to assignment) and change in glycemic control (HbA 1c ']","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0220952', 'cui_str': 'DSM-IV'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0043157', 'cui_str': 'Whites'}, {'cui': 'C0555047', 'cui_str': 'Married (finding)'}]","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0453962', 'cui_str': 'Trainers (physical object)'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}]","[{'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C0205487', 'cui_str': 'Psychiatric (qualifier value)'}, {'cui': 'C0021821', 'cui_str': 'Interviewers'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0019016', 'cui_str': 'Hemoglobin A'}]",,0.0698781,"After controlling for education and antidepressant use, odds of achieving full MDD remission in the intervention groups were 5.0-6.8 times greater than UC ( P < 0.0167).","[{'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'de Groot', 'Affiliation': 'Indiana University School of Medicine, Indianapolis, IN mdegroot@iu.edu.'}, {'ForeName': 'Jay H', 'Initials': 'JH', 'LastName': 'Shubrook', 'Affiliation': 'Touro University California College of Osteopathic Medicine, Vallejo, CA.'}, {'ForeName': 'W Guyton', 'Initials': 'WG', 'LastName': 'Hornsby', 'Affiliation': 'West Virginia University School of Medicine, Morgantown, WV.'}, {'ForeName': 'Yegan', 'Initials': 'Y', 'LastName': 'Pillay', 'Affiliation': 'Ohio University, Athens, OH.'}, {'ForeName': 'Kieren J', 'Initials': 'KJ', 'LastName': 'Mather', 'Affiliation': 'Indiana University School of Medicine, Indianapolis, IN.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Fitzpatrick', 'Affiliation': 'West Virginia University School of Medicine, Morgantown, WV.'}, {'ForeName': 'Ziyi', 'Initials': 'Z', 'LastName': 'Yang', 'Affiliation': 'Indiana University School of Medicine, Indianapolis, IN.'}, {'ForeName': 'Chandan', 'Initials': 'C', 'LastName': 'Saha', 'Affiliation': 'Indiana University School of Medicine, Indianapolis, IN.'}]",Diabetes care,['10.2337/dc18-2400'] 3215,30951166,"A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Single-Dose, Phase III, Non-Inferiority Study Comparing PrabotulinumtoxinA and OnabotulinumtoxinA for the Treatment of Moderate to Severe Glabellar Lines in Adult Patients.","BACKGROUND PrabotulinumtoxinA is a 900-kDa botulinum toxin type A produced by Clostridium botulinum. OBJECTIVES The authors sought to investigate the efficacy and safety of prabotulinumtoxinA compared to onabotulinumtoxinA and placebo for the treatment of glabellar lines. METHODS This was a 150-day, multicenter, double-blind, controlled, single-dose Phase III study. Adult patients (n = 540) with moderate to severe glabellar lines at maximum frown as assessed by the investigator on the validated 4-point Glabellar Line Scale (0 = no lines, 1 = mild, 2 = moderate, 3 = severe), who also felt that their glabellar lines had an important psychological impact, were enrolled. Patients were randomized 5:5:1 to receive a single treatment (0.1 mL injected into each of 5 glabellar sites) of 20 U prabotulinumtoxinA (n = 245), 20 U onabotulinumtoxinA (n = 246), or placebo (n = 49). The primary efficacy endpoint was the proportion of responders (patients with a Glabellar Line Scale score of 0 or 1 at maximum frown by investigator assessment) on day 30. RESULTS Responder rates for the primary efficacy endpoint were 87.2%, 82.8%, and 4.2% in the prabotulinumtoxinA, onabotulinumtoxinA, and placebo groups, respectively. The absolute difference between prabotulinumtoxinA and onabotulinumtoxinA groups was 4.4% (95% confidence interval [-1.9, 10.8]). Given that the lower bound of the 95% confidence interval for the difference was less than -10.0%, noninferiority of prabotulinumtoxinA vs onabotulinumtoxinA was concluded. Five patients (3 prabotulinumtoxinA, 1.2%; 1 onabotulinumtoxinA, 0.4%; 1 placebo, 2.0%) experienced serious adverse events, none of which were study drug related. CONCLUSIONS A single treatment of 20 U prabotulinumtoxinA was safe and effective and noninferior to 20 U onabotulinumtoxinA for the treatment of moderate to severe glabellar lines. LEVEL OF EVIDENCE: 1 ",2020,A single treatment of 20 U prabotulinumtoxinA was safe and effective and non-inferior to 20 U onabotulinumtoxinA for the treatment of moderate to severe glabellar lines.,"['glabellar lines', 'Moderate to Severe Glabellar Lines in Adult Subjects', 'Adult subjects (n=540) with moderate to severe glabellar lines at maximum frown as assessed by the investigator on the validated 4-point Glabellar Line Scale (GLS, 0=no lines, 1=mild, 2=moderate, 3=severe), who also felt that their glabellar lines had an important psychological impact, were enrolled']","['PrabotulinumtoxinA and OnabotulinumtoxinA', 'Placebo', '20 U onabotulinumtoxinA (n=246) or placebo', 'prabotulinumtoxinA', '20 U prabotulinumtoxinA', 'onabotulinumtoxinA and placebo', 'prabotulinumtoxinA versus onabotulinumtoxinA']","['proportion of responders (subjects with a GLS score of 0 or 1 at maximum frown by investigator assessment) on Day 30', 'serious adverse events', 'efficacy and safety']","[{'cui': 'C0442019', 'cui_str': 'Glabellar (qualifier value)'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0035173', 'cui_str': 'Investigators'}, {'cui': 'C0222045'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C1527305', 'cui_str': 'Feelings'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}]","[{'cui': 'C2719767', 'cui_str': 'onabotulinumtoxinA'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0035173', 'cui_str': 'Investigators'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.292837,A single treatment of 20 U prabotulinumtoxinA was safe and effective and non-inferior to 20 U onabotulinumtoxinA for the treatment of moderate to severe glabellar lines.,"[{'ForeName': 'Berthold-Josef', 'Initials': 'BJ', 'LastName': 'Rzany', 'Affiliation': 'Dermatologist in private practice in Berlin, Germany.'}, {'ForeName': 'Benjamin', 'Initials': 'B', 'LastName': 'Ascher', 'Affiliation': 'Plastic Surgeon, Lecturer, and Clinical Assistant, Paris Academy, Head of Clinique de Chirurgie Esthétique Iéna, Paris, France.'}, {'ForeName': 'Rui L', 'Initials': 'RL', 'LastName': 'Avelar', 'Affiliation': 'Chief Medical Officer and Head of Research and Development, Evolus, Inc., Newport Beach, CA.'}, {'ForeName': 'Jesper', 'Initials': 'J', 'LastName': 'Bergdahl', 'Affiliation': 'Consultant Plastic Surgeon, Department of Plastic Surgery, Örebro University Hospital, and Akademikliniken Örebro, Örebro, Sweden.'}, {'ForeName': 'Vince', 'Initials': 'V', 'LastName': 'Bertucci', 'Affiliation': 'Instructor, Division of Dermatology, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Isaac', 'Initials': 'I', 'LastName': 'Bodokh', 'Affiliation': 'Dermatologist, Practicien Hospitalier, Service de Dermatologie, Cannes Hospital Simone Veil, Cannes, France.'}, {'ForeName': 'James Alastair', 'Initials': 'JA', 'LastName': 'Carruthers', 'Affiliation': 'Dermatologist (retired) in private practice, Vancouver, BC, Canada.'}, {'ForeName': 'Hugues', 'Initials': 'H', 'LastName': 'Cartier', 'Affiliation': 'Dermatologist, Dermatology Clinic, Centre Médical Saint-Jean, Arras, France.'}, {'ForeName': 'Henry', 'Initials': 'H', 'LastName': 'Delmar', 'Affiliation': 'Plastic surgeon in private practice in Antibes, France.'}, {'ForeName': 'Ralf', 'Initials': 'R', 'LastName': 'Denfeld', 'Affiliation': 'Private practice physician in Stuttgart, Germany.'}, {'ForeName': 'John E', 'Initials': 'JE', 'LastName': 'Gross', 'Affiliation': 'Vice Dean for Clinical Affairs, School of Medicine, UCI Health, Orange, CA.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Heckmann', 'Affiliation': 'Associate Professor of Dermatology, Ludwig Maximilian Universität, Munich, Germany.'}, {'ForeName': 'Per', 'Initials': 'P', 'LastName': 'Hedén', 'Affiliation': 'Associate Professor in Plastic Surgery, Akademikliniken Stockholm, Sweden.'}, {'ForeName': 'Said', 'Initials': 'S', 'LastName': 'Hilton', 'Affiliation': 'Dermatologist in private practice in Düsseldorf, Germany.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Inglefield', 'Affiliation': 'Inglefield is a plastic surgeon in private practice in London, United Kingdom.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Ogilvie', 'Affiliation': 'Dermatologist in private practice in Munich, Germany.'}, {'ForeName': 'Gerhard', 'Initials': 'G', 'LastName': 'Sattler', 'Affiliation': 'Medical Director, Rosenpark Research, Darmstadt, Germany.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Sebastian', 'Affiliation': 'Dermatologist in private practice in Brandenburg, Germany.'}, {'ForeName': 'Nowell', 'Initials': 'N', 'LastName': 'Solish', 'Affiliation': 'Assistant Professor of Dermatology, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Arthur', 'Initials': 'A', 'LastName': 'Swift', 'Affiliation': 'Clinical Lecturer, McGill University and University of Montreal, Montreal, PQ, Canada.'}, {'ForeName': 'Patrick', 'Initials': 'P', 'LastName': 'Trévidic', 'Affiliation': 'Scientific Director, Expert2Expert Group, Paris, France.'}]",Aesthetic surgery journal,['10.1093/asj/sjz110'] 3216,31994819,Need for pacing in patients who qualify for an implantable cardioverter-defibrillator: Clinical implications for the subcutaneous ICD.,"BACKGROUND Implantation of the subcutaneous implantable cardioverter-defibrillator (S-ICD) is spreading and has been shown to be safe and effective; however, it does not provide brady-pacing. Currently, data on the need for brady-pacing and cardiac resynchronization therapy (CRT) implantation in patients with ICD indication are limited. METHODS The Multicenter Automatic Defibrillator Implantation Trial (MADIT)-II enrolled post-MI patients with reduced ejection fraction (EF ≤ 35%), randomized to either an implantable cardioverter-defibrillator (ICD) or conventional medical therapy. Kaplan-Meier analyses and multivariate Cox models were performed to assess the incidence and predictors of pacemaker (PM), or CRT implantation in the conventional arm of MADIT-II, after excluding 32 patients (6.5%) with a previously implanted PM. RESULTS During the median follow-up of 20 months, 24 of 458 patients (5.2%) were implanted with a PM or a CRT (19 PM, 5 CRT). Symptomatic sinus bradycardia was the primary indication for PM implantation (n = 9, 37%), followed by AV block (n = 5, 21%), tachy-brady syndrome (n = 4, 17%), and carotid sinus hypersensitivity (n = 1, 4%). Baseline PR interval >200 ms (HR = 3.07, 95% CI: 1.24-7.57, p = .02), and CABG before enrollment (HR = 6.88, 95% CI: 1.58-29.84, p = .01) predicted subsequent PM/CRT implantation. Patients with PM/CRT implantation had a significantly higher risk for heart failure (HR = 2.67, 95% CI = 1.38-5.14, p = .003), but no increased mortality risk (HR = 1.06, 95% CI = 0.46-2.46, p = .89). CONCLUSION The short-term need for ventricular pacing or CRT implantation in patients with MADIT-II ICD indication was low, especially in those with a normal baseline PR interval, and such patients are appropriate candidates for the subcutaneous ICD.",2020,"Baseline PR interval >200 ms (HR = 3.07, 95% CI: 1.24-7.57, p = .02), and CABG before enrollment (HR = 6.88, 95% CI: 1.58-29.84, p = .01) predicted subsequent PM/CRT implantation.","['patients with ICD', 'MI patients with reduced ejection fraction (EF\xa0≤\xa035', 'patients who qualify for an implantable cardioverter-defibrillator']","['ventricular pacing or CRT implantation', 'subcutaneous implantable cardioverter-defibrillator (S-ICD', 'cardiac resynchronization therapy (CRT) implantation', 'implantable cardioverter-defibrillator (ICD) or conventional medical therapy']","['incidence and predictors of pacemaker (PM), or CRT implantation', 'carotid sinus hypersensitivity', 'mortality risk', 'Symptomatic sinus bradycardia', 'risk for heart failure']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0162589', 'cui_str': 'Implantable Cardioverter-Defibrillators'}]","[{'cui': 'C0562458', 'cui_str': 'Pacing up and down (finding)'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}, {'cui': 'C1522438', 'cui_str': 'SC use'}, {'cui': 'C0162589', 'cui_str': 'Implantable Cardioverter-Defibrillators'}, {'cui': 'C1167956', 'cui_str': 'Cardiac Resynchronization'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0418981', 'cui_str': 'Medical therapy (procedure)'}]","[{'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}, {'cui': 'C0741983', 'cui_str': 'Carotid sinus hypersensitivity'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0748712', 'cui_str': 'Symptomatic sinus bradycardia (disorder)'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}]",,0.084377,"Baseline PR interval >200 ms (HR = 3.07, 95% CI: 1.24-7.57, p = .02), and CABG before enrollment (HR = 6.88, 95% CI: 1.58-29.84, p = .01) predicted subsequent PM/CRT implantation.","[{'ForeName': 'Valentina', 'Initials': 'V', 'LastName': 'Kutyifa', 'Affiliation': 'Heart Research Follow-Up Program, University of Rochester Medical Center, Rochester, NY, USA.'}, {'ForeName': 'Spencer Z', 'Initials': 'SZ', 'LastName': 'Rosero', 'Affiliation': 'Heart Research Follow-Up Program, University of Rochester Medical Center, Rochester, NY, USA.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'McNitt', 'Affiliation': 'Heart Research Follow-Up Program, University of Rochester Medical Center, Rochester, NY, USA.'}, {'ForeName': 'Bronislava', 'Initials': 'B', 'LastName': 'Polonsky', 'Affiliation': 'Heart Research Follow-Up Program, University of Rochester Medical Center, Rochester, NY, USA.'}, {'ForeName': 'Mary W', 'Initials': 'MW', 'LastName': 'Brown', 'Affiliation': 'Heart Research Follow-Up Program, University of Rochester Medical Center, Rochester, NY, USA.'}, {'ForeName': 'Wojciech', 'Initials': 'W', 'LastName': 'Zareba', 'Affiliation': 'Heart Research Follow-Up Program, University of Rochester Medical Center, Rochester, NY, USA.'}, {'ForeName': 'Ilan', 'Initials': 'I', 'LastName': 'Goldenberg', 'Affiliation': 'Heart Research Follow-Up Program, University of Rochester Medical Center, Rochester, NY, USA.'}]","Annals of noninvasive electrocardiology : the official journal of the International Society for Holter and Noninvasive Electrocardiology, Inc",['10.1111/anec.12744'] 3217,31813354,Brain Natriuretic Peptide and Discovery of Atrial Fibrillation After Stroke: A Subanalysis of the Find-AF RANDOMISED Trial.,"Background and Purpose- Diagnosing paroxysmal atrial fibrillation (pAF) can be challenging after acute ischemic stroke. Enhanced and prolonged Holter-ECG monitoring (EPM) improves the detection rate but is not feasible for all patients. We hypothesized that brain natriuretic peptide (BNP) may help to identify patients with stroke at high risk for pAF to select patients for EPM more effectively. Methods- Patients with acute cerebral ischemia ≥60 years presenting in sinus rhythm and without history of AF were included into a prospective, randomized multicenter study to receive either EPM (3× 10-day Holter-ECG) or usual stroke care diagnostic work-up. BNP plasma levels were measured on randomization and 3 months thereafter. Levels were compared between patients with and without pAF detected by means of EPM or usual care. Furthermore, the number needed to screen for EPM depending on BNP cut offs was calculated. Results- A total of 398 patients were analyzed. In 373 patients (93.7%), BNP was measured at baseline and in 275 patients (69.1%) after 3 months. pAF was found in 27 patients by means of EPM and in 9 patients by means of usual care ( P =0.002). Median BNP was higher in patients with pAF as compared to patients without AF in both study arms at baseline (57.8 versus 28.3 pg/mL in the EPM arm, P =0.0003; 46.2 versus 27.7 pg/mL, P =0.28 in the control arm) and after 3 months (74.9 versus 31.3 pg/mL, P =0.012 in the EPM arm, 99.3 versus 26.3 pg/mL, P =0.02 in the control arm). Applying a cut off of 100 pg/mL, the number needed to screen was reduced from 18 by usual care to 3 by EPM. Conclusions- BNP measured early after ischemic stroke identifies a subgroup of patients with stroke at increased risk for AF, in whom EPM is particularly efficacious. Registration- URL: https://www.clinicaltrials.gov. Unique identifier: NCT01855035.",2020,Enhanced and prolonged Holter-ECG monitoring (EPM) improves the detection rate but is not feasible for all patients.,"['A total of 398 patients were analyzed', 'Methods- Patients with acute cerebral ischemia ≥60 years presenting in sinus rhythm and without history of AF']","['Conclusions- BNP', 'pAF', 'EPM (3× 10-day Holter-ECG) or usual stroke care diagnostic work-up', 'prolonged Holter-ECG monitoring (EPM', 'brain natriuretic peptide (BNP', ' and Purpose']","['detection rate', 'BNP', 'BNP plasma levels', 'Brain Natriuretic Peptide and Discovery of Atrial Fibrillation', 'Median BNP']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C2215101', 'cui_str': 'Acute cerebral ischemia (disorder)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C0232201', 'cui_str': 'Coronary sinus rhythm'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}]","[{'cui': 'C1095989', 'cui_str': 'Brain natriuretic peptide measurement (procedure)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C1623258', 'cui_str': 'ECG'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0348026', 'cui_str': 'Diagnostic'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0439590', 'cui_str': 'Prolonged (qualifier value)'}, {'cui': 'C0180580', 'cui_str': 'Electrocardiographic monitoring'}, {'cui': 'C0054015', 'cui_str': 'Nesiritide'}, {'cui': 'C1285529', 'cui_str': 'Purpose (attribute)'}]","[{'cui': 'C1095989', 'cui_str': 'Brain natriuretic peptide measurement (procedure)'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0054015', 'cui_str': 'Nesiritide'}, {'cui': 'C0004238', 'cui_str': 'Auricular Fibrillation'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]",398.0,0.147919,Enhanced and prolonged Holter-ECG monitoring (EPM) improves the detection rate but is not feasible for all patients.,"[{'ForeName': 'Katrin', 'Initials': 'K', 'LastName': 'Wasser', 'Affiliation': 'From the Clinic for Neurology (K.W., J.L., P.K.), University of Göttingen, Germany.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Weber-Krüger', 'Affiliation': 'Clinic for Cardiology and Pneumology (M.W.-K., R.W.), University of Göttingen, Germany.'}, {'ForeName': 'Sonja', 'Initials': 'S', 'LastName': 'Gröschel', 'Affiliation': 'Clinic and Policlinic for Neurology, University of Mainz, Germany (S.G., T.U., K.G.).'}, {'ForeName': 'Timo', 'Initials': 'T', 'LastName': 'Uphaus', 'Affiliation': 'Clinic and Policlinic for Neurology, University of Mainz, Germany (S.G., T.U., K.G.).'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Liman', 'Affiliation': 'From the Clinic for Neurology (K.W., J.L., P.K.), University of Göttingen, Germany.'}, {'ForeName': 'Gerhard F', 'Initials': 'GF', 'LastName': 'Hamann', 'Affiliation': 'Clinic for Neurology and Neurorehabilitation, Bezirkskrankenhaus Günzburg, Germany (G.F.H.).'}, {'ForeName': 'Pawel', 'Initials': 'P', 'LastName': 'Kermer', 'Affiliation': 'From the Clinic for Neurology (K.W., J.L., P.K.), University of Göttingen, Germany.'}, {'ForeName': 'Joachim', 'Initials': 'J', 'LastName': 'Seegers', 'Affiliation': 'Division of Cardiology, Department of Internal Medicine II, University Hospital Regensburg, Germany (J.S.).'}, {'ForeName': 'Lutz', 'Initials': 'L', 'LastName': 'Binder', 'Affiliation': 'Institute for Clinical Chemistry (L.B.), University of Göttingen, Germany.'}, {'ForeName': 'Götz', 'Initials': 'G', 'LastName': 'Gelbrich', 'Affiliation': 'Institute for Clinical Epidemiology and Biometry, University of Würzburg, Germany (G.G.).'}, {'ForeName': 'Klaus', 'Initials': 'K', 'LastName': 'Gröschel', 'Affiliation': 'Clinic and Policlinic for Neurology, University of Mainz, Germany (S.G., T.U., K.G.).'}, {'ForeName': 'Rolf', 'Initials': 'R', 'LastName': 'Wachter', 'Affiliation': 'Clinic for Cardiology and Pneumology (M.W.-K., R.W.), University of Göttingen, Germany.'}]",Stroke,['10.1161/STROKEAHA.119.026496'] 3218,31996605,A Clinical Trial Investigating Telehealth and In-Person Social Communication Skills Training for People With Traumatic Brain Injury: Participant-Reported Communication Outcomes.,"OBJECTIVE To investigate the efficacy of telehealth-based and in-person social communication skills training (TBIconneCT) for people with moderate to severe traumatic brain injury (TBI) based on outcomes reported by the survivor and a close communication partner. SETTING Australia. Two telehealth dyads were located outside Australia. PARTICIPANTS Adults (n = 51) at least 6 months after moderate-severe TBI with social communication skills deficits, and their usual communication partners (family members, friends, or paid carers). DESIGN Partially randomized controlled trial, with a telehealth intervention group, in-person intervention group, and a historical control group. MAIN MEASURES La Trobe Communication Questionnaire (LCQ) (total score, and number of items with perceived positive change). Both self- and other-reports. RESULTS Trained participants had significantly more items with perceived positive change than did historical controls. A medium effect size in the sample was observed for improvements in total score reported by trained communication partners after treatment. Comparisons between telehealth and in-person groups found medium to large effect sizes in the sample, favoring the telehealth group on some LCQ variables. CONCLUSIONS Whether delivered via telehealth or in-person, social communication skills training led to perceived positive change in communication skills. It was unexpected that outcomes for the telehealth group were better than for the in-person group on some variables.",2020,"Comparisons between telehealth and in-person groups found medium to large effect sizes in the sample, favoring the telehealth group on some LCQ variables. ","['People With Traumatic Brain Injury', 'Australia', 'people with moderate to severe traumatic brain injury (TBI', 'Adults (n = 51']","['historical control group', 'telehealth-based and in-person social communication skills training (TBIconneCT', 'telehealth intervention', 'Person Social Communication Skills Training']","['total score', 'La Trobe Communication Questionnaire (LCQ) (total score, and number of items with perceived positive change']","[{'cui': 'C0876926', 'cui_str': 'TBI (Traumatic Brain Injury)'}, {'cui': 'C0004340', 'cui_str': 'Australia'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]","[{'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1328956', 'cui_str': 'eHealth'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0588407', 'cui_str': 'Communication skills training (procedure)'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0009452', 'cui_str': 'Communication'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}]",,0.101985,"Comparisons between telehealth and in-person groups found medium to large effect sizes in the sample, favoring the telehealth group on some LCQ variables. ","[{'ForeName': 'Rachael', 'Initials': 'R', 'LastName': 'Rietdijk', 'Affiliation': 'Faculty of Health Sciences, The University of Sydney, Australia (Ms Rietdijk and Drs Power, Attard, Heard, and Togher); and Graduate School of Health, The University of Technology Sydney, Australia (Dr Power).'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Power', 'Affiliation': ''}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Attard', 'Affiliation': ''}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Heard', 'Affiliation': ''}, {'ForeName': 'Leanne', 'Initials': 'L', 'LastName': 'Togher', 'Affiliation': ''}]",The Journal of head trauma rehabilitation,['10.1097/HTR.0000000000000554'] 3219,31986239,"Evaluating body composition in infancy and childhood: A comparison between 4C, QMR, DXA, and ADP.","BACKGROUND Accurate and precise methods to measure of body composition in infancy and childhood are needed. OBJECTIVES This study evaluated differences and precision of three methods when compared with the four-compartment (4C) model for estimating fat mass (FM). METHODS FM of children (age 14 days to 6 years of age, N = 346) was obtained using quantitative nuclear magnetic resonance (QMR, EchoMRI-AH), air-displacement plethysmography (ADP, PeaPod, less than or equal to 8 kg, BodPod age 6 years or older), and dual-energy X-ray absorptiometry (DXA, Hologic QDR). The 4C model was computed. Correlation, concordance, and Bland-Altman analyses were performed. RESULTS In infants, PeaPod had high individual FM accuracy, whereas DXA had high group FM accuracy compared with 4C. In children, DXA had high group and individual FM accuracies compared with 4C. QMR underestimated group FM in infants and children (300 and 510 g, respectively). The instrument FM precision was best for QMR (10 g) followed by BodPod (34 g), PeaPod (38 g), and DXA (45 g). CONCLUSIONS In infants, PeaPod was the best method to estimate individual FM whereas DXA was best to estimate group FM. In children, DXA was best to estimate individual and group FM. QMR had the highest instrument precision.",2020,"In children, DXA had high group and individual FM accuracies compared with 4C. QMR underestimated group FM in infants and children (300 and 510 g, respectively).","['infancy and childhood', 'FM of children (age 14\u2009days to 6\u2009years of age, N = 346']","['quantitative nuclear magnetic resonance (QMR, EchoMRI-AH), air-displacement plethysmography (ADP, PeaPod, less than or equal to 8 kg, BodPod age 6\u2009years or older), and dual-energy X-ray absorptiometry (DXA, Hologic QDR']","['individual FM accuracy', 'individual FM accuracies', 'FM accuracy']","[{'cui': 'C0231330', 'cui_str': 'Infancy - period'}, {'cui': 'C0231335', 'cui_str': 'Childhood (finding)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0392762', 'cui_str': 'Quantitative (qualifier value)'}, {'cui': 'C0028580', 'cui_str': 'Nuclear Magnetic Resonance'}, {'cui': 'C0001861', 'cui_str': 'Air'}, {'cui': 'C0456080', 'cui_str': 'Displacement (attribute)'}, {'cui': 'C0032221', 'cui_str': 'Plethysmography'}, {'cui': 'C0001459', 'cui_str': ""Adenosine 5'-Pyrophosphate""}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C1510486', 'cui_str': 'Dual X-Ray Absorptiometry'}]","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}]",,0.0298047,"In children, DXA had high group and individual FM accuracies compared with 4C. QMR underestimated group FM in infants and children (300 and 510 g, respectively).","[{'ForeName': 'Melissa E', 'Initials': 'ME', 'LastName': 'Heard-Lipsmeyer', 'Affiliation': ""Arkansas Children's Nutrition Center, University of Arkansas for Medical Sciences, Little Rock, Arkansas.""}, {'ForeName': 'Holly', 'Initials': 'H', 'LastName': 'Hull', 'Affiliation': 'Department of Dietetics and Nutrition, University of Kansas Medical Center, Kansas City, Kansas.'}, {'ForeName': 'Clark R', 'Initials': 'CR', 'LastName': 'Sims', 'Affiliation': ""Arkansas Children's Nutrition Center, University of Arkansas for Medical Sciences, Little Rock, Arkansas.""}, {'ForeName': 'Mario A', 'Initials': 'MA', 'LastName': 'Cleves', 'Affiliation': ""Arkansas Children's Nutrition Center, University of Arkansas for Medical Sciences, Little Rock, Arkansas.""}, {'ForeName': 'Aline', 'Initials': 'A', 'LastName': 'Andres', 'Affiliation': ""Arkansas Children's Nutrition Center, University of Arkansas for Medical Sciences, Little Rock, Arkansas.""}]",Pediatric obesity,['10.1111/ijpo.12617'] 3220,31842688,End-of-Treatment Intracerebral and Ventricular Hemorrhage Volume Predicts Outcome: A Secondary Analysis of MISTIE III.,"Background and Purpose- Trials have shown potential clinical benefit for minimally invasive clot evacuation of intracerebral hemorrhage (ICH). Prior research showing an association between ICH size and functional outcome did not fully address the spectrum of hematoma volumes seen after clot evacuation. Methods- In this secondary analysis of the MISTIE III trial (Minimally Invasive Surgery Plus Alteplase for Intracerebral Hemorrhage Evacuation III), we included patients randomized to the surgical arm. The primary outcome was good outcome (modified Rankin Scale score 0-3 at 1 year from study enrollment). The primary predictors were the end-of-treatment (EoT) ICH and intraventricular hemorrhage volumes and an end-of-treatment ICH stratification scale called the EoT ICH volume score. Results- In 246 patients, the end-of-treatment computed tomography was performed an average of 5 days from onset. For patients with good versus poor outcomes, the mean end-of-treatment ICH and intraventricular hemorrhage volumes were 12.9 versus 18.0 mL ( P =0.002) and 0.5 versus 2.3 mL ( P <0.001), respectively. The probability of a good outcome decreased from 73% for EoT ICH volume 3 (<5 mL) to 28% for EoT ICH volume 0 (>20 mL; P =0.001). Conclusions- After surgical clot evacuation, both ICH and intraventricular hemorrhage volumes have a strong association with good neurological outcome. The EoT ICH volume score needs independent verification, but such an approach could be used for prognostication and therapeutic planning.",2020,The probability of a good outcome decreased from 73% for EoT ICH volume 3 (<5 mL) to 28% for EoT ICH volume 0,['Intracerebral Hemorrhage Evacuation III'],"['Methods', ' and Purpose']","['good outcome (modified Rankin Scale score 0-3 at 1 year from study enrollment', 'mean end-of-treatment ICH and intraventricular hemorrhage volumes', 'end-of-treatment (EoT) ICH and intraventricular hemorrhage volumes and an end-of-treatment ICH stratification scale called the EoT ICH volume score']","[{'cui': 'C2937358', 'cui_str': 'Intracerebral Hemorrhage'}, {'cui': 'C1282573', 'cui_str': 'Evacuation procedure'}, {'cui': 'C0439070', 'cui_str': 'III'}]","[{'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C1285529', 'cui_str': 'Purpose (attribute)'}]","[{'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0451405', 'cui_str': 'Rankin scale'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0240059', 'cui_str': 'Ventricular hemorrhage (disorder)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C1720420', 'cui_str': 'Call'}]",246.0,0.0819232,The probability of a good outcome decreased from 73% for EoT ICH volume 3 (<5 mL) to 28% for EoT ICH volume 0,"[{'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'de Havenon', 'Affiliation': 'From the Departments of Neurology (A.d.H., S.A., A.D.), Clinical Neurosciences Center, University of Utah, Salt Lake City.'}, {'ForeName': 'Evan', 'Initials': 'E', 'LastName': 'Joyce', 'Affiliation': 'Neurosurgery (E.J., P.T., R.G.), Clinical Neurosciences Center, University of Utah, Salt Lake City.'}, {'ForeName': 'Shadi', 'Initials': 'S', 'LastName': 'Yaghi', 'Affiliation': 'the Department of Neurology, New York University (S.Y.).'}, {'ForeName': 'Safdar', 'Initials': 'S', 'LastName': 'Ansari', 'Affiliation': 'From the Departments of Neurology (A.d.H., S.A., A.D.), Clinical Neurosciences Center, University of Utah, Salt Lake City.'}, {'ForeName': 'Alen', 'Initials': 'A', 'LastName': 'Delic', 'Affiliation': 'From the Departments of Neurology (A.d.H., S.A., A.D.), Clinical Neurosciences Center, University of Utah, Salt Lake City.'}, {'ForeName': 'Philipp', 'Initials': 'P', 'LastName': 'Taussky', 'Affiliation': 'Neurosurgery (E.J., P.T., R.G.), Clinical Neurosciences Center, University of Utah, Salt Lake City.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Alexander', 'Affiliation': 'Radiology (M.A.), Clinical Neurosciences Center, University of Utah, Salt Lake City.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Tirschwell', 'Affiliation': 'the Department of Neurology, University of Washington, Seattle (D.T.).'}, {'ForeName': 'Ramesh', 'Initials': 'R', 'LastName': 'Grandhi', 'Affiliation': 'Neurosurgery (E.J., P.T., R.G.), Clinical Neurosciences Center, University of Utah, Salt Lake City.'}]",Stroke,['10.1161/STROKEAHA.119.028199'] 3221,32156749,A Randomized Phase II Preoperative Study of Autophagy Inhibition with High-Dose Hydroxychloroquine and Gemcitabine/Nab-Paclitaxel in Pancreatic Cancer Patients.,"PURPOSE We hypothesized that autophagy inhibition would increase response to chemotherapy in the preoperative setting for patients with pancreatic adenocarcinoma. We performed a randomized controlled trial to assess the autophagy inhibitor hydroxychloroquine in combination with gemcitabine and nab-paclitaxel. PATIENTS AND METHODS Participants with potentially resectable tumors were randomized to two cycles of nab-paclitaxel and gemcitabine (PG) alone or with hydroxychloroquine (PGH), followed by resection. The primary endpoint was histopathologic response in the resected specimen. Secondary clinical endpoints included serum CA 19-9 biomarker response and margin negative R0 resection. Exploratory endpoints included markers of autophagy, immune infiltrate, and serum cytokines. RESULTS Thirty-four patients in the PGH arm and 30 in the PG arm were evaluable for the primary endpoint. The PGH arm demonstrated statistically improved Evans grade histopathologic responses ( P = 0.00016), compared with control. In patients with elevated CA 19-9, a return to normal was associated with improved overall and recurrence-free survival ( P < 0.0001). There were no differences in serious adverse events between arms and chemotherapy dose number was equivalent. The PGH arm had greater evidence of autophagy inhibition in their resected specimens (increased SQSTM1, P = 0.027, as well as increased immune cell tumor infiltration, P = 0.033). Overall survival ( P = 0.59) and relapse-free survival ( P = 0.55) did not differ between the two arms. CONCLUSIONS The addition of hydroxychloroquine to preoperative gemcitabine and nab-paclitaxel chemotherapy in patients with resectable pancreatic adenocarcinoma resulted in greater pathologic tumor response, improved serum biomarker response, and evidence of autophagy inhibition and immune activity.",2020,"In patients with elevated CA 19-9, a return to normal was associated with improved overall and recurrence-free survival (P < 0.0001).","['patients with resectable pancreatic adenocarcinoma', 'patients with pancreatic adenocarcinoma', 'Pancreatic Cancer Patients', 'Participants with potentially resectable tumors']","['nab-paclitaxel and gemcitabine (PG) alone or with hydroxychloroquine (PGH', 'hydroxychloroquine to preoperative gemcitabine and nab-paclitaxel chemotherapy', 'gemcitabine and nab-paclitaxel', 'Hydroxychloroquine and Gemcitabine/Nab-Paclitaxel', 'autophagy inhibitor hydroxychloroquine', 'Autophagy Inhibition']","['pathological tumor response, improved serum biomarker response, and evidence of autophagy inhibition and immune activity', 'overall and recurrence-free survival', 'serious adverse events', 'markers of autophagy, immune infiltrate, and serum cytokines', 'CA 19-9 serum biomarker response and margin negative R0 resection', 'RFS', 'autophagy inhibition', 'histopathologic response', 'Evans grade histopathologic responses']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0281361', 'cui_str': 'Adenocarcinoma of pancreas'}, {'cui': 'C0346647', 'cui_str': 'Cancer of Pancreas'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}]","[{'cui': 'C1527223', 'cui_str': '130-nm albumin-bound paclitaxel'}, {'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C0020336', 'cui_str': 'Hydroxychloroquine'}, {'cui': 'C0072288', 'cui_str': 'Prostaglandin H2'}, {'cui': 'C0445204', 'cui_str': 'Preoperative (qualifier value)'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0004391', 'cui_str': 'Cellular Autophagies'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}]","[{'cui': 'C1521733', 'cui_str': 'Pathologic (qualifier value)'}, {'cui': 'C0027651', 'cui_str': 'Neoplasia'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0332120', 'cui_str': 'Evidence of (contextual qualifier) (qualifier value)'}, {'cui': 'C0004391', 'cui_str': 'Cellular Autophagies'}, {'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}, {'cui': 'C0439662', 'cui_str': 'Immune (qualifier value)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C2919733', 'cui_str': 'Surviving free of recurrence of neoplastic disease (finding)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0332448', 'cui_str': 'Tissue infiltration'}, {'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}, {'cui': 'C0201551', 'cui_str': 'CA 199 measurement'}, {'cui': 'C0205284', 'cui_str': 'Marginal (qualifier value)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}]",34.0,0.0657666,"In patients with elevated CA 19-9, a return to normal was associated with improved overall and recurrence-free survival (P < 0.0001).","[{'ForeName': 'Herbert J', 'Initials': 'HJ', 'LastName': 'Zeh', 'Affiliation': 'Department of Surgery, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Nathan', 'Initials': 'N', 'LastName': 'Bahary', 'Affiliation': 'Department of Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania. baharyn@upmc.edu.'}, {'ForeName': 'Brian A', 'Initials': 'BA', 'LastName': 'Boone', 'Affiliation': 'Department of Surgery, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Aatur D', 'Initials': 'AD', 'LastName': 'Singhi', 'Affiliation': 'Department of Pathology, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Jennifer Lee', 'Initials': 'JL', 'LastName': 'Miller-Ocuin', 'Affiliation': 'Department of Surgery, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Daniel P', 'Initials': 'DP', 'LastName': 'Normolle', 'Affiliation': 'Department of Biostatistics, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Amer H', 'Initials': 'AH', 'LastName': 'Zureikat', 'Affiliation': 'Department of Surgery, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Melissa E', 'Initials': 'ME', 'LastName': 'Hogg', 'Affiliation': 'Department of Surgery, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'David L', 'Initials': 'DL', 'LastName': 'Bartlett', 'Affiliation': 'Department of Surgery, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Kenneth K', 'Initials': 'KK', 'LastName': 'Lee', 'Affiliation': 'Department of Surgery, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Allan', 'Initials': 'A', 'LastName': 'Tsung', 'Affiliation': 'Department of Surgery, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'J Wallis', 'Initials': 'JW', 'LastName': 'Marsh', 'Affiliation': 'Department of Surgery, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Pranav', 'Initials': 'P', 'LastName': 'Murthy', 'Affiliation': 'Department of Surgery, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Daolin', 'Initials': 'D', 'LastName': 'Tang', 'Affiliation': 'Department of Surgery, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Natalie', 'Initials': 'N', 'LastName': 'Seiser', 'Affiliation': ""HPB and Transplant Institute at St. Vincent's Medical Center, Los Angeles, California.""}, {'ForeName': 'Ravi K', 'Initials': 'RK', 'LastName': 'Amaravadi', 'Affiliation': 'Department of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.'}, {'ForeName': 'Virginia', 'Initials': 'V', 'LastName': 'Espina', 'Affiliation': 'Center for Applied Proteomics and Molecular Medicine, George Mason University, Manassas, Virginia.'}, {'ForeName': 'Lance', 'Initials': 'L', 'LastName': 'Liotta', 'Affiliation': 'Center for Applied Proteomics and Molecular Medicine, George Mason University, Manassas, Virginia.'}, {'ForeName': 'Michael T', 'Initials': 'MT', 'LastName': 'Lotze', 'Affiliation': 'Department of Surgery, University of Pittsburgh, Pittsburgh, Pennsylvania.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-19-4042'] 3222,32195749,Who Accepts and Who Uses Community-Based Secondary Distribution HIV Self-Testing (HIVST) Kits? Findings From the Intervention Arm of a Cluster-Randomized Trial of HIVST Distribution Nested in Four HPTN 071 (PopART) Communities in Zambia.,"BACKGROUND HPTN 071 (PopART) was a community-randomized trial of a universal testing-and-treatment intervention on HIV incidence at population level in Zambia and South Africa. In Zambia, a trial of community-based distribution of HIV self-testing (HIVST) kits, including secondary distribution, as an option for HIV-testing was nested within 4 PopART intervention communities. We used data from the intervention arm of the nested trial to measure levels of and factors associated with acceptance and use of secondary distribution HIVST kits. METHODS Community HIV care providers offered the PopART combination HIV-prevention intervention door-to-door, systematically visiting all households and enumerating all household members. From 1 February to 30 April 2017, individuals aged 16 years and older consenting to PopART were offered the option to HIV self-test, if eligible for HIV-testing services. Individuals aged 18 years and older who reported a partner absent during household visits were offered an HIVST kit for secondary distribution to this partner. We used two data sources to measure acceptance and use of secondary distribution HIVST kits. RESULTS Among 9105 individuals aged 18 years and older consenting to PopART, 9.1% (n = 825) accepted an HIVST kit for secondary distribution. Approximately 55.8% reported that the kit had been used. Women were more likely to accept, and men more likely to use, secondary distribution HIVST kits. Kits were more likely to be used by individuals aged 30+ and who had not participated in a previous round of PopART. Approximately 6.8% had a reactive result. CONCLUSIONS Community-based secondary distribution of HIVST kits reached men absent during community HIV care provider household visits and is a complement to facility- and community-based HIV-testing services, which often miss men.",2020,Kits were more likely to be used by individuals aged 30+ and who had not participated in a previous round of PopART.,"['9,105 individuals ≥18-years consenting to PopART, 9.1% (n=825) accepted an HIVST kit for secondary distribution', 'individuals aged 30+ and who had not participated in a previous round of PopART', 'HIV incidence at population-level in Zambia and South Africa', 'distribution nested in four HPTN 071 (PopART) communities in Zambia', 'Individuals ≥18-years who reported a partner absent during household visits', 'Community HIV Care Providers (CHiPs) offered the PopART combination HIV-prevention intervention door-to-door, systematically visiting all households and enumerating all household members']","['universal testing-and-treatment intervention', 'HIVST', 'HIVST kit']",[],"[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C2711213', 'cui_str': 'Consented (qualifier value)'}, {'cui': 'C1272684', 'cui_str': 'Accepted'}, {'cui': 'C1690540', 'cui_str': 'Kit'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0037775', 'cui_str': 'Distributions (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0043445', 'cui_str': 'Republic of Zambia'}, {'cui': 'C0037712', 'cui_str': 'Union of South Africa'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0682323', 'cui_str': 'Companion'}, {'cui': 'C0332197', 'cui_str': 'Absent (qualifier value)'}, {'cui': 'C0020052', 'cui_str': 'Households'}, {'cui': 'C1444648', 'cui_str': 'Offered'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0557698', 'cui_str': 'Door (physical object)'}]","[{'cui': 'C0175671', 'cui_str': 'Universal (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1690540', 'cui_str': 'Kit'}]",[],,0.0372186,Kits were more likely to be used by individuals aged 30+ and who had not participated in a previous round of PopART.,"[{'ForeName': 'Bernadette', 'Initials': 'B', 'LastName': 'Hensen', 'Affiliation': 'Clinical Research Department, London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Albertus J', 'Initials': 'AJ', 'LastName': 'Schaap', 'Affiliation': 'Department of Infectious Disease Epidemiology, London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Chama', 'Initials': 'C', 'LastName': 'Mulubwa', 'Affiliation': 'Zambart, Lusaka, Zambia.'}, {'ForeName': 'Sian', 'Initials': 'S', 'LastName': 'Floyd', 'Affiliation': 'Department of Infectious Disease Epidemiology, London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Kwame', 'Initials': 'K', 'LastName': 'Shanaube', 'Affiliation': 'Zambart, Lusaka, Zambia.'}, {'ForeName': 'Mwelwa M', 'Initials': 'MM', 'LastName': 'Phiri', 'Affiliation': 'Zambart, Lusaka, Zambia.'}, {'ForeName': 'Virginia', 'Initials': 'V', 'LastName': 'Bond', 'Affiliation': 'Zambart, Lusaka, Zambia.'}, {'ForeName': 'Chiti', 'Initials': 'C', 'LastName': 'Bwalya', 'Affiliation': 'Zambart, Lusaka, Zambia.'}, {'ForeName': 'Musonda', 'Initials': 'M', 'LastName': 'Simwinga', 'Affiliation': 'Zambart, Lusaka, Zambia.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Fidler', 'Affiliation': 'Imperial College, London, United Kingdom and Imperial College NIHR BRC.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Hayes', 'Affiliation': 'Department of Infectious Disease Epidemiology, London School of Hygiene and Tropical Medicine, London, United Kingdom.'}, {'ForeName': 'Alwyn', 'Initials': 'A', 'LastName': 'Mwinga', 'Affiliation': 'Zambart, Lusaka, Zambia.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Ayles', 'Affiliation': 'Clinical Research Department, London School of Hygiene and Tropical Medicine, London, United Kingdom.'}]",Journal of acquired immune deficiency syndromes (1999),['10.1097/QAI.0000000000002344'] 3223,32195897,Rapid Advancement in Enteral Nutrition Does Not Affect Systemic Inflammation and Insulin Homeostasis Following Pediatric Cardiopulmonary Bypass Surgery.,"OBJECTIVES To determine impact of enteral nutrition delivery on the relationship among inflammation, insulin resistance, and outcomes following pediatric cardiopulmonary bypass surgery. DESIGN Pilot, randomized study analyzed according to intention-to-treat analysis. SETTING Pediatric cardiac ICU. PATIENTS Infants (≤ 6 mo) undergoing cardiopulmonary bypass. INTERVENTIONS Patients randomly assigned to receive rapid escalation to enteral nutrition reaching goal feeds by 27 hours or standard feeding practice reaching goal feeds by 63 hours. Feeds were initiated on the first postoperative day. MEASUREMENTS AND MAIN RESULTS Fifty patients were randomized equally to study arms. Patients were a median (interquartile range) of 16 days old (7-110 d old), undergoing biventricular surgery (88%) with a median cardiopulmonary bypass time of 125 minutes (105-159 min). Serial blood samples were drawn before and after cardiopulmonary bypass, cardiac ICU admission, and every 12 hours (up to 96 hr) for glucose, insulin, and cytokines (interleukin-1α, interleukin-6, interleukin-8, interleukin-10, and tumor necrosis factor-α) levels. Glucose-insulin ratio was calculated to quantify insulin resistance. Patient characteristics, time to enteral nutrition initiation, enteral nutrition interruptions, and insulin administration were similar across intervention arms. FF reached goal feeds at similar intervals as standard feeding (39 hr [30-60 hr] vs 60 hr [21-78 hr]; p = 0.75). No difference in cytokine, insulin, or glucose-insulin ratio was noted between groups. Higher inflammation was associated with increased glucose-insulin ratio and higher risk of adverse events. In multivariable models of interleukin-8, FF was associated with increased glucose-insulin ratio (estimate of effect [95% CI], 0.152 [0.033-0.272]; p = 0.013). Although higher interleukin-8 was associated with an elevated risk of adverse event, this relationship was possibly mitigated by FF (odds ratio [95% CI], 0.086 [0.002-1.638]; p = 0.13). CONCLUSIONS A FF strategy was not associated with changes to early enteral nutrition delivery. Inflammation, insulin resistance, and morbidity were similar, but FF may modify the relationship between inflammation and adverse event. Multicenter nutrition studies are possible and necessary in this vulnerable population.",2020,"In multivariable models of interleukin-8, FF was associated with increased glucose-insulin ratio (estimate of effect [95% CI], 0.152 [0.033-0.272]; p = 0.013).","['Infants (≤ 6 mo) undergoing cardiopulmonary bypass', 'Fifty patients', 'Pediatric Cardiopulmonary Bypass Surgery', 'Patients were a median (interquartile range) of 16 days old (7-110 d old), undergoing biventricular surgery (88%) with a median cardiopulmonary bypass time of 125 minutes (105-159 min', 'pediatric cardiopulmonary bypass surgery']",['enteral nutrition delivery'],"['Systemic Inflammation and Insulin Homeostasis', 'cytokine, insulin, or glucose-insulin ratio', 'Glucose-insulin ratio', 'Patient characteristics, time to enteral nutrition initiation, enteral nutrition interruptions, and insulin administration', 'glucose, insulin, and cytokines (interleukin-1α, interleukin-6, interleukin-8, interleukin-10, and tumor necrosis factor-α) levels', 'Inflammation, insulin resistance, and morbidity', 'glucose-insulin ratio and higher risk of adverse events', 'glucose-insulin ratio']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0007202', 'cui_str': 'Heart-Lung Bypass'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0030755', 'cui_str': 'Pediatrics'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C1292718', 'cui_str': 'Is a'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C4517536', 'cui_str': '110 (qualifier value)'}, {'cui': 'C0429123', 'cui_str': 'Cardiopulmonary bypass time (observable entity)'}, {'cui': 'C4319551', 'cui_str': 'One hundred and twenty-five'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C4319547', 'cui_str': '105'}]","[{'cui': 'C0086225', 'cui_str': 'Enteral Feeding'}, {'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}]","[{'cui': 'C0205373', 'cui_str': 'Systemic (qualifier value)'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0019868', 'cui_str': 'Autoregulation'}, {'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0086225', 'cui_str': 'Enteral Feeding'}, {'cui': 'C0589507', 'cui_str': 'Cognitive function: initiation (observable entity)'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0021764', 'cui_str': 'Interleukins'}, {'cui': 'C0021760', 'cui_str': 'Interleukin-6'}, {'cui': 'C0079633', 'cui_str': 'Interleukin-8'}, {'cui': 'C0085295', 'cui_str': 'Interleukin-10'}, {'cui': 'C0041368', 'cui_str': 'Tumor Necrosis Factors'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C0332167', 'cui_str': 'High risk of (contextual qualifier) (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",50.0,0.273371,"In multivariable models of interleukin-8, FF was associated with increased glucose-insulin ratio (estimate of effect [95% CI], 0.152 [0.033-0.272]; p = 0.013).","[{'ForeName': 'Alejandro A', 'Initials': 'AA', 'LastName': 'Floh', 'Affiliation': 'Labatt Family Heart Centre, Department of Critical Care Medicine, University of Toronto, The Hospital for Sick Children, Toronto, ON, Canada.'}, {'ForeName': 'Joann', 'Initials': 'J', 'LastName': 'Herridge', 'Affiliation': 'Labatt Family Heart Centre, Department of Critical Care Medicine, University of Toronto, The Hospital for Sick Children, Toronto, ON, Canada.'}, {'ForeName': 'Chun-Po S', 'Initials': 'CS', 'LastName': 'Fan', 'Affiliation': 'Cardiovascular Data Management Centre, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Cedric', 'Initials': 'C', 'LastName': 'Manlhiot', 'Affiliation': 'Cardiovascular Data Management Centre, University of Toronto, Toronto, ON, Canada.'}, {'ForeName': 'Brian W', 'Initials': 'BW', 'LastName': 'McCrindle', 'Affiliation': 'Labatt Family Heart Centre, Division of Cardiology, University of Toronto, The Hospital for Sick Children, Toronto, ON, Canada.'}, {'ForeName': 'Glen', 'Initials': 'G', 'LastName': 'Van Arsdell', 'Affiliation': 'Labatt Family Heart Centre, Division of Cardiovascular Surgery, University of Toronto, The Hospital for Sick Children, Toronto, ON, Canada.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Balmer-Minnes', 'Affiliation': ''}, {'ForeName': 'Steven M', 'Initials': 'SM', 'LastName': 'Schwartz', 'Affiliation': 'Labatt Family Heart Centre, Department of Critical Care Medicine, University of Toronto, The Hospital for Sick Children, Toronto, ON, Canada.'}]",Pediatric critical care medicine : a journal of the Society of Critical Care Medicine and the World Federation of Pediatric Intensive and Critical Care Societies,['10.1097/PCC.0000000000002314'] 3224,32181499,Objective and subjective reduction of cellulite volume using a localized vibrational massage device in a 24-week randomized intra-individual single-blind regression study.,"Cellulite occurs in females and is a common condition of altered connective tissue matrix and increased adipogenicity with visible dimples and orange-peel appearance on the skins surface. Whilst advancements in methods continue to help our understanding, attempts to correct the appearance of cellulite topically have yielded limited success. Various kinds of non-invasive body contouring methods such as whole body vibration have been reported with demonstrable visible improvements in the cellulite condition. The aim of this study was to evaluate volume reduction and improvement of the visible appearance of cellulite as judged both objectively (AEVA-HE phase-shift 3-D fringe projection, macrophotography image grading) and subjectively (questionnaires) after application of a hand-held localized vibrational device over 24-weeks. The study was conducted on 40 healthy female volunteers who were instructed how to use the device on defined areas of cellulite of the outside and rear of the thighs (iliotibial band, and over biceps femoris region respectively). The initial 12 weeks of continuous massage application of the study were followed by a 12 week phase in which volunteers were split into 2 subgroups - one for assessment of regression effects and one for continuous application effects. AEVA (skin surface volume) measurements of cellulite-related dimples correlated with questionnaires and visual image evaluation scoring, in that in the iliotibial region cellulite was significantly reduced at 12 weeks. In the regression subgroup cellulite returned to initial values soon after cessation of treatment, whereas in the continuous application subgroup, cellulite remained diminished. The effect of this device to reduce cellulite as observed in this study proves that continuous use of vibrational massage is beneficial to mitigate visible signs of cellulite.",2020,The effect of this device to reduce cellulite as observed in this study is proves that continuous use of vibrational massage is beneficial to mitigate visible signs of cellulite.,"['40 healthy female volunteers who were instructed how to use the device on defined areas of cellulite of the outside and rear of the thighs (iliotibial band, and over biceps femoris region respectively']",['localized vibrational massage device'],['iliotibial region cellulite'],"[{'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C0424624', 'cui_str': 'Cellulite'}, {'cui': 'C0205101', 'cui_str': 'External (qualifier value)'}, {'cui': 'C0039866', 'cui_str': 'Thigh'}, {'cui': 'C0185014', 'cui_str': 'Banding'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}]","[{'cui': 'C0024875', 'cui_str': 'Massage'}, {'cui': 'C0220819', 'cui_str': 'devices'}]","[{'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0424624', 'cui_str': 'Cellulite'}]",40.0,0.0183326,The effect of this device to reduce cellulite as observed in this study is proves that continuous use of vibrational massage is beneficial to mitigate visible signs of cellulite.,"[{'ForeName': 'T', 'Initials': 'T', 'LastName': 'Sadowski', 'Affiliation': 'proDERM Institute of Applied Dermatological Research GmbH, 22869, Schenefeld-Hamburg, Germany.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Bielfeldt', 'Affiliation': 'proDERM Institute of Applied Dermatological Research GmbH, 22869, Schenefeld-Hamburg, Germany.'}, {'ForeName': 'K-P', 'Initials': 'KP', 'LastName': 'Wilhelm', 'Affiliation': 'proDERM Institute of Applied Dermatological Research GmbH, 22869, Schenefeld-Hamburg, Germany.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Sukopp', 'Affiliation': 'Beurer GmbH, 89077, Ulm-Donau, Germany.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Gordon', 'Affiliation': 'CIT Research Institute, Ahornstr. 31, 70597, Stuttgart, Germany.'}]",International journal of cosmetic science,['10.1111/ics.12613'] 3225,31270506,Investigation of the role of typhoid toxin in acute typhoid fever in a human challenge model.,"Salmonella Typhi is a human host-restricted pathogen that is responsible for typhoid fever in approximately 10.9 million people annually 1 . The typhoid toxin is postulated to have a central role in disease pathogenesis, the establishment of chronic infection and human host restriction 2-6 . However, its precise role in typhoid disease in humans is not fully defined. We studied the role of typhoid toxin in acute infection using a randomized, double-blind S. Typhi human challenge model 7 . Forty healthy volunteers were randomized (1:1) to oral challenge with 10 4 colony-forming units of wild-type or an isogenic typhoid toxin deletion mutant (TN) of S. Typhi. We observed no significant difference in the rate of typhoid infection (fever ≥38 °C for ≥12 h and/or S. Typhi bacteremia) between participants challenged with wild-type or TN S. Typhi (15 out of 21 (71%) versus 15 out of 19 (79%); P = 0.58). The duration of bacteremia was significantly longer in participants challenged with the TN strain compared with wild-type (47.6 hours (28.9-97.0) versus 30.3(3.6-49.4); P ≤ 0.001). The clinical syndrome was otherwise indistinguishable between wild-type and TN groups. These data suggest that the typhoid toxin is not required for infection and the development of early typhoid fever symptoms within the context of a human challenge model. Further clinical data are required to assess the role of typhoid toxin in severe disease or the establishment of bacterial carriage.",2019,The duration of bacteremia was significantly longer in participants challenged with the TN strain compared with wild-type (47.6 hours (28.9-97.0) versus 30.3(3.6-49.4); P ≤ 0.001).,['Forty healthy volunteers'],"['oral challenge with 10 4 colony-forming units of wild-type or an isogenic typhoid toxin deletion mutant (TN) of S. Typhi', 'typhoid toxin']","['rate of typhoid infection', 'duration of bacteremia']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0553561', 'cui_str': 'colony-forming unit (qualifier value)'}, {'cui': 'C0445392', 'cui_str': 'Wild (qualifier value)'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0041466', 'cui_str': 'Salmonella typhi Infection'}, {'cui': 'C4522020', 'cui_str': 'Toxin'}, {'cui': 'C1442161', 'cui_str': 'Deletion (morphologic abnormality)'}]","[{'cui': 'C0041466', 'cui_str': 'Salmonella typhi Infection'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0004610', 'cui_str': 'Bacteremia'}]",40.0,0.136122,The duration of bacteremia was significantly longer in participants challenged with the TN strain compared with wild-type (47.6 hours (28.9-97.0) versus 30.3(3.6-49.4); P ≤ 0.001).,"[{'ForeName': 'Malick M', 'Initials': 'MM', 'LastName': 'Gibani', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford and the NIHR Oxford Biomedical Research Centre, Oxford, UK. malick.gibani@paediatrics.ox.ac.uk.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Jones', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford and the NIHR Oxford Biomedical Research Centre, Oxford, UK.'}, {'ForeName': 'Amber', 'Initials': 'A', 'LastName': 'Barton', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford and the NIHR Oxford Biomedical Research Centre, Oxford, UK.'}, {'ForeName': 'Celina', 'Initials': 'C', 'LastName': 'Jin', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford and the NIHR Oxford Biomedical Research Centre, Oxford, UK.'}, {'ForeName': 'Juliette', 'Initials': 'J', 'LastName': 'Meek', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford and the NIHR Oxford Biomedical Research Centre, Oxford, UK.'}, {'ForeName': 'Susana', 'Initials': 'S', 'LastName': 'Camara', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford and the NIHR Oxford Biomedical Research Centre, Oxford, UK.'}, {'ForeName': 'Ushma', 'Initials': 'U', 'LastName': 'Galal', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, Clinical Trials Unit, University of Oxford, Oxford, UK.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Heinz', 'Affiliation': 'Wellcome Sanger Institute, Wellcome Genome Campus, Hinxton, UK.'}, {'ForeName': 'Yael', 'Initials': 'Y', 'LastName': 'Rosenberg-Hasson', 'Affiliation': 'Human Immune Monitoring Center, Institute for Immunity, Transplantation and Infection, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Gerlinde', 'Initials': 'G', 'LastName': 'Obermoser', 'Affiliation': 'Human Immune Monitoring Center, Institute for Immunity, Transplantation and Infection, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Jones', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford and the NIHR Oxford Biomedical Research Centre, Oxford, UK.'}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Campbell', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford and the NIHR Oxford Biomedical Research Centre, Oxford, UK.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Black', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford and the NIHR Oxford Biomedical Research Centre, Oxford, UK.'}, {'ForeName': 'Helena', 'Initials': 'H', 'LastName': 'Thomaides-Brears', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford and the NIHR Oxford Biomedical Research Centre, Oxford, UK.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Darlow', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford and the NIHR Oxford Biomedical Research Centre, Oxford, UK.'}, {'ForeName': 'Christina', 'Initials': 'C', 'LastName': 'Dold', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford and the NIHR Oxford Biomedical Research Centre, Oxford, UK.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Silva-Reyes', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford and the NIHR Oxford Biomedical Research Centre, Oxford, UK.'}, {'ForeName': 'Luke', 'Initials': 'L', 'LastName': 'Blackwell', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford and the NIHR Oxford Biomedical Research Centre, Oxford, UK.'}, {'ForeName': 'Maria', 'Initials': 'M', 'LastName': 'Lara-Tejero', 'Affiliation': 'Department of Microbial Pathogenesis, Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Xuyao', 'Initials': 'X', 'LastName': 'Jiao', 'Affiliation': 'Department of Microbial Pathogenesis, Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Gabrielle', 'Initials': 'G', 'LastName': 'Stack', 'Affiliation': 'Department of Microbial Pathogenesis, Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Christoph J', 'Initials': 'CJ', 'LastName': 'Blohmke', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford and the NIHR Oxford Biomedical Research Centre, Oxford, UK.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Hill', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford and the NIHR Oxford Biomedical Research Centre, Oxford, UK.'}, {'ForeName': 'Brian', 'Initials': 'B', 'LastName': 'Angus', 'Affiliation': 'Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Gordon', 'Initials': 'G', 'LastName': 'Dougan', 'Affiliation': 'Wellcome Sanger Institute, Wellcome Genome Campus, Hinxton, UK.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Galán', 'Affiliation': 'Department of Microbial Pathogenesis, Yale University School of Medicine, New Haven, CT, USA.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Pollard', 'Affiliation': 'Oxford Vaccine Group, Department of Paediatrics, University of Oxford and the NIHR Oxford Biomedical Research Centre, Oxford, UK.'}]",Nature medicine,['10.1038/s41591-019-0505-4'] 3226,31884309,Impact of CPAP treatment on leptin and adiponectin in adults with coronary artery disease and nonsleepy obstructive sleep apnoea in the RICCADSA trial.,"BACKGROUND Increased leptin and decreased adiponectin levels are reported in coronary artery disease (CAD) as well as in obstructive sleep apnoea (OSA). Less is known regarding the impact of continuous positive airway pressure (CPAP) on these biomarkers. We aimed to determine variables associated with leptin and adiponectin in adults with CAD and nonsleepy OSA, and evaluate the effect of CPAP adjusted for confounding factors. METHODS This was one of the secondary outcomes of the RICCADSA trial, conducted in Sweden between 2005 and 2013. From 244 revascularized CAD and OSA patients (apnoea-hypopnoea index >15/h) without excessive daytime sleepiness (Epworth Sleepiness Scale score <10), 196 with blood samples at baseline, after 3, and 12 months were included in the randomized controlled trial arm; of those, 98 were allocated to auto-titrating CPAP, and 98 to no-CPAP. RESULTS No significant changes in leptin and adiponectin levels were observed during follow-up, whereas Body-Mass-Index and waist circumference increased in both CPAP and no-CPAP groups with no significant between-group differences. Alterations in plasma leptin were determined by changes in waist circumference (beta coefficient 2.47; 95% confidence interval 0.77-4.40), whereas none of the analyzed parameters was predictive for changes in adiponectin levels. No association was found with CPAP adherence. CONCLUSIONS CPAP had no significant effect on leptin and adiponectin in this cohort of nonsleepy OSA patients. An increase in waist circumference predicted an increase in plasma levels of leptin after 12 months, suggesting that lifestyle modifications should be given priority in adults with CAD and OSA regardless of CPAP treatment.",2020,"Alterations in plasma leptin were determined by changes in waist circumference (beta coefficient 2.47; 95% confidence interval 0.77-4.40), whereas none of the analyzed parameters was predictive for changes in adiponectin levels.","['From 244 revascularized CAD and OSA patients (apnoea-hypopnoea index ', 'adults with CAD and nonsleepy OSA', 'adults with coronary artery disease and nonsleepy obstructive sleep apnoea in the RICCADSA trial']",['CPAP'],"['leptin and adiponectin', 'CPAP adherence', 'leptin and adiponectin levels', 'adiponectin levels', 'waist circumference', 'Body-Mass-Index and waist circumference', 'plasma leptin', 'plasma levels of leptin', 'excessive daytime sleepiness (Epworth Sleepiness Scale score']","[{'cui': 'C4517660', 'cui_str': 'Two hundred and forty-four'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2111846', 'cui_str': 'Apnea-hypopnea index'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}, {'cui': 'C0520679', 'cui_str': 'Syndrome, Sleep Apnea, Obstructive'}]","[{'cui': 'C0199451', 'cui_str': 'Continuous Positive Airway Pressure'}]","[{'cui': 'C0299583', 'cui_str': 'leptin'}, {'cui': 'C0389071', 'cui_str': 'Adiponectin'}, {'cui': 'C0199451', 'cui_str': 'Continuous Positive Airway Pressure'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0455829', 'cui_str': 'Waist Circumference'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C4551761', 'cui_str': 'Excessive daytime sleepiness'}, {'cui': 'C4706348', 'cui_str': 'Epworth Sleepiness Scale score (observable entity)'}]",98.0,0.0637554,"Alterations in plasma leptin were determined by changes in waist circumference (beta coefficient 2.47; 95% confidence interval 0.77-4.40), whereas none of the analyzed parameters was predictive for changes in adiponectin levels.","[{'ForeName': 'Baran', 'Initials': 'B', 'LastName': 'Balcan', 'Affiliation': 'Dept. of Pulmonary Medicine, Marmara University, School of Medicine, Istanbul, Turkey.'}, {'ForeName': 'Erik', 'Initials': 'E', 'LastName': 'Thunström', 'Affiliation': 'Sahlgrenska Academy, University of Gothenburg, Sweden.'}, {'ForeName': 'Tülay', 'Initials': 'T', 'LastName': 'Yucel-Lindberg', 'Affiliation': 'Division of Periodontology, Department of Dental Medicine, Karolinska Institutet, Huddinge, Sweden.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Lindberg', 'Affiliation': 'Division of Periodontology, Department of Dental Medicine, Karolinska Institutet, Huddinge, Sweden.'}, {'ForeName': 'Pinar', 'Initials': 'P', 'LastName': 'Ay', 'Affiliation': 'Dept. of Public Health, Marmara University, School of Medicine, Istanbul, Turkey.'}, {'ForeName': 'Yüksel', 'Initials': 'Y', 'LastName': 'Peker', 'Affiliation': 'Sahlgrenska Academy, University of Gothenburg, Sweden; Dept. of Pulmonary Medicine, Koc University, School of Medicine, Istanbul, Turkey; Division of Pulmonary, Allergy, and Critical Care Medicine, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA. Electronic address: yukselpeker26@gmail.com.'}]",Sleep medicine,['10.1016/j.sleep.2019.10.016'] 3227,32041881,Cannabis increases susceptibility to false memory.,"With the growing global acceptance of cannabis and its widespread use by eyewitnesses and suspects in legal cases, understanding the popular drug's ramifications for memory is a pressing need. In a double-blind, randomized, placebo-controlled trial, we examined the acute and delayed effects of Δ9-tetrahydrocannabinol (THC) intoxication on susceptibility to false memory in 64 healthy volunteers. Memory was tested immediately (encoding and retrieval under drug influence) and 1 wk later (retrieval sober). We used three different methods (associative word lists and two misinformation tasks using virtual reality). Across all methods, we found evidence for enhanced false-memory effects in intoxicated participants. Specifically, intoxicated participants showed higher false recognition in the associative word-list task both at immediate and delayed test than controls. This yes bias became increasingly strong with decreasing levels of association between studied and test items. In a misinformation task, intoxicated participants were more susceptible to false-memory creation using a virtual-reality eyewitness scenario and virtual-reality perpetrator scenario. False-memory effects were mostly restricted to the acute-intoxication phase. Cannabis seems to increase false-memory proneness, with decreasing strength of association between an event and a test item, as assessed by different false-memory paradigms. Our findings have implications for how and when the police should interview suspects and eyewitnesses.",2020,"In a misinformation task, intoxicated participants were more susceptible to false-memory creation using a virtual-reality eyewitness scenario and virtual-reality perpetrator scenario.",['64 healthy volunteers'],"['placebo', 'Δ9-tetrahydrocannabinol (THC) intoxication']","['False-memory effects', 'false recognition']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0039663', 'cui_str': 'dronabinol'}, {'cui': 'C0728899', 'cui_str': 'Intoxication'}]","[{'cui': 'C0561845', 'cui_str': 'False memories (finding)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0233798', 'cui_str': 'False recognition (finding)'}]",64.0,0.0937391,"In a misinformation task, intoxicated participants were more susceptible to false-memory creation using a virtual-reality eyewitness scenario and virtual-reality perpetrator scenario.","[{'ForeName': 'Lilian', 'Initials': 'L', 'LastName': 'Kloft', 'Affiliation': 'Faculty of Psychology and Neuroscience, Maastricht University, 6229 ER Maastricht, The Netherlands; l.kloft@maastrichtuniversity.nl eloftus@uci.edu j.ramaekers@maastrichtuniversity.nl.'}, {'ForeName': 'Henry', 'Initials': 'H', 'LastName': 'Otgaar', 'Affiliation': 'Faculty of Psychology and Neuroscience, Maastricht University, 6229 ER Maastricht, The Netherlands.'}, {'ForeName': 'Arjan', 'Initials': 'A', 'LastName': 'Blokland', 'Affiliation': 'Faculty of Psychology and Neuroscience, Maastricht University, 6229 ER Maastricht, The Netherlands.'}, {'ForeName': 'Lauren A', 'Initials': 'LA', 'LastName': 'Monds', 'Affiliation': 'Faculty of Medicine and Health, The University of Sydney, Sydney, NSW 2006, Australia.'}, {'ForeName': 'Stefan W', 'Initials': 'SW', 'LastName': 'Toennes', 'Affiliation': 'Department of Forensic Toxicology, Institute of Legal Medicine, Goethe University of Frankfurt, 60323 Frankfurt, Germany.'}, {'ForeName': 'Elizabeth F', 'Initials': 'EF', 'LastName': 'Loftus', 'Affiliation': 'Department of Psychological Science, University of California, Irvine, CA 92697 l.kloft@maastrichtuniversity.nl eloftus@uci.edu j.ramaekers@maastrichtuniversity.nl.'}, {'ForeName': 'Johannes G', 'Initials': 'JG', 'LastName': 'Ramaekers', 'Affiliation': 'Faculty of Psychology and Neuroscience, Maastricht University, 6229 ER Maastricht, The Netherlands; l.kloft@maastrichtuniversity.nl eloftus@uci.edu j.ramaekers@maastrichtuniversity.nl.'}]",Proceedings of the National Academy of Sciences of the United States of America,['10.1073/pnas.1920162117'] 3228,32125718,"Soft tissue expander for vertically atrophied alveolar ridges: Prospective, multicenter, randomized controlled trial.","OBJECTIVES Conventional guided bone regeneration (GBR) limits the amount of bone graft due to limited soft tissue expansion. We hypothesize that the use of tissue expander will successfully augment soft tissue prior to bone graft, allowing for sufficient amount of grafting which will lead to a more stable and effective vertical bone graft. The authors aimed to evaluate effectiveness of the novel self-inflating tissue expander for vertical augmentation in terms of soft tissue expansion, clinical outcomes, and related complications. MATERIAL AND METHODS A prospective, multicenter, randomized controlled trial was performed on patients requiring vertical augmentation. For experimental group patients, the tissue expander was subperiosteally implanted and followed by a tunneling bone graft without full flap reflection. Control patients underwent conventional vertical GBR. Primary objectives were to evaluate the dimensional changes of soft tissue and radiographic vertical bone gain and retention. As a secondary outcome, clinical complications and thickness changes of expanded overlying tissue were assessed and analyzed. RESULTS Twenty-three patients in each group were included. During a 4-week expansion, two of the experimental group showed over-expansion and one showed mucosal perforation associated with previous severe scars. The other patients showed uneventful expansion and mean tissue augmentation was 6.88 ± 1.64 mm vertically. Ultrasonographic measurements of overlying gingiva revealed no thinning after tissue expansion (p > .05). Significantly higher vertical bone gain was shown in the experimental group (5.12 ± 1.25 mm) compared with that in the control patients (4.22 ± 1.15 mm; p < .05). After a 6-month retention period, the mean vertical bone measurement of the controls had decreased to 1.90 mm (55.0% reduction), which was a significantly greater decrease than that in the experimental group (mean 3.55 mm, 30.7% reduction; p < .05). CONCLUSION Our results demonstrated the effectiveness of tissue expanders followed by tunneling bone graft for vertical augmentation; however, studies comparing the two techniques without tissue expanders are needed to elucidate the net effect of tissue expansion.",2020,Significantly higher vertical bone gain was shown in the experimental group (5.12 ± 1.25 mm) compared with that in the control patients (4.22 ± 1.15 mm; P<0.05).,"['patients requiring vertical augmentation', 'Vertically Atrophied Alveolar Ridges', 'Twenty-three patients in each group were included']","['novel self-inflating tissue expander for vertical augmentation', 'conventional vertical GBR', 'Conventional guided bone regeneration (GBR']","['mucosal perforation', 'clinical complications and thickness changes of expanded overlying tissue', 'uneventful expansion and mean tissue augmentation', 'vertical bone gain', 'dimensional changes of soft tissue and radiographic vertical bone gain and retention', 'mean vertical bone measurement']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205128', 'cui_str': 'Vertical (qualifier value)'}, {'cui': 'C1293122', 'cui_str': 'Augmentation procedure'}, {'cui': 'C0333641', 'cui_str': 'Atrophy'}, {'cui': 'C0447411', 'cui_str': 'Alveolar ridge structure (body structure)'}, {'cui': 'C0450348', 'cui_str': '23 (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0040289', 'cui_str': 'Tissue Expanders'}, {'cui': 'C0205128', 'cui_str': 'Vertical (qualifier value)'}, {'cui': 'C1293122', 'cui_str': 'Augmentation procedure'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0005972', 'cui_str': 'Bone Regeneration'}]","[{'cui': 'C0026724', 'cui_str': 'Mucosal Tissue'}, {'cui': 'C0549099', 'cui_str': 'Perforation (morphologic abnormality)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0205229', 'cui_str': 'Expanding (qualifier value)'}, {'cui': 'C0040300', 'cui_str': 'Tissues'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1293122', 'cui_str': 'Augmentation procedure'}, {'cui': 'C0205128', 'cui_str': 'Vertical (qualifier value)'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0225317', 'cui_str': 'Soft tissues (body structure)'}, {'cui': 'C0444708', 'cui_str': 'Radiographic (qualifier value)'}, {'cui': 'C0035280', 'cui_str': 'Retention'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}]",23.0,0.0412032,Significantly higher vertical bone gain was shown in the experimental group (5.12 ± 1.25 mm) compared with that in the control patients (4.22 ± 1.15 mm; P<0.05).,"[{'ForeName': 'Soo-Hwan', 'Initials': 'SH', 'LastName': 'Byun', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Dentistry, Sacred Heart Hospital, Hallym University Medical Center, Kyonggi-do, Korea.'}, {'ForeName': 'Seon-Yeong', 'Initials': 'SY', 'LastName': 'Kim', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Ewha Womans University Medical Center, Seoul, Korea.'}, {'ForeName': 'Ho', 'Initials': 'H', 'LastName': 'Lee', 'Affiliation': 'Research Society of Gangnam Oral and Maxillofacial Surgeons, Seoul, Korea.'}, {'ForeName': 'Ho-Kyung', 'Initials': 'HK', 'LastName': 'Lim', 'Affiliation': 'Research Society of Gangnam Oral and Maxillofacial Surgeons, Seoul, Korea.'}, {'ForeName': 'Ju-Won', 'Initials': 'JW', 'LastName': 'Kim', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Dentistry, Sacred Heart Hospital, Hallym University Medical Center, Kyonggi-do, Korea.'}, {'ForeName': 'Ui-Lyong', 'Initials': 'UL', 'LastName': 'Lee', 'Affiliation': 'Research Society of Gangnam Oral and Maxillofacial Surgeons, Seoul, Korea.'}, {'ForeName': 'Jong-Bin', 'Initials': 'JB', 'LastName': 'Lee', 'Affiliation': 'Department of Periodontoloy, Ewha Womans University Medical Center, Seoul, Korea.'}, {'ForeName': 'Sung-Ho', 'Initials': 'SH', 'LastName': 'Park', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Ewha Womans University Medical Center, Seoul, Korea.'}, {'ForeName': 'Sun-Jong', 'Initials': 'SJ', 'LastName': 'Kim', 'Affiliation': 'Department of Oral and Maxillofacial Surgery, Ewha Womans University Medical Center, Seoul, Korea.'}, {'ForeName': 'Ju-Dong', 'Initials': 'JD', 'LastName': 'Song', 'Affiliation': 'Bio R&D Center, Osstem implant Co., Ltd., Busan, Korea.'}, {'ForeName': 'Il-Seok', 'Initials': 'IS', 'LastName': 'Jang', 'Affiliation': 'Bio R&D Center, Osstem implant Co., Ltd., Busan, Korea.'}, {'ForeName': 'Min-Kyoung', 'Initials': 'MK', 'LastName': 'Kim', 'Affiliation': 'Bio R&D Center, Osstem implant Co., Ltd., Busan, Korea.'}, {'ForeName': 'Jin-Woo', 'Initials': 'JW', 'LastName': 'Kim', 'Affiliation': 'Research Society of Gangnam Oral and Maxillofacial Surgeons, Seoul, Korea.'}]",Clinical oral implants research,['10.1111/clr.13595'] 3229,31104832,"Immunogenicity of full and fractional dose of inactivated poliovirus vaccine for use in routine immunisation and outbreak response: an open-label, randomised controlled trial.","BACKGROUND Intradermal administration of fractional inactivated poliovirus vaccine (fIPV) is a dose-sparing alternative to the intramuscular full dose. We aimed to compare the immunogenicity of two fIPV doses versus one IPV dose for routine immunisation, and also assessed the immunogenicity of an fIPV booster dose for an outbreak response. METHODS We did an open-label, randomised, controlled, inequality, non-inferiority trial in two clinics in Dhaka, Bangladesh. Healthy infants were randomly assigned at 6 weeks to one of four groups: group A received IPV at age 14 weeks and IPV booster at age 22 weeks; group B received IPV at age 14 weeks and fIPV booster at age 22 weeks; group C received IPV at age 6 weeks and fIPV booster at age 22 weeks; and group D received fIPV at 6 weeks and 14 weeks and fIPV booster at age 22 weeks. IPV was administered by needle-syringe as an intramuscular full dose (0·5 mL), and fIPV was administered intradermally (0·1 mL of the IPV formulation was administered using the 0·1 mL HelmJect auto-disable syringe with a Helms intradermal adapter). Both IPV and fIPV were administered on the outer, upper right thigh of infants. The primary outcome was vaccine response to poliovirus types 1, 2, and 3 at age 22 weeks (routine immunisation) and age 26 weeks (outbreak response). Vaccine response was defined as seroconversion from seronegative (<1:8) at baseline to seropositive (≥1:8) or four-fold increase in reciprocal antibody titres adjusted for maternal antibody decay and was assessed in the modified intention-to-treat population (infants who received polio vaccines per group assignment and polio antibody titre results to serotypes 1, 2, and 3 at 6, 22, 23, and 26 weeks of age). The non-inferiority margin was 12·5%. This trial is registered with ClinicalTrials.gov, number NCT02847026. FINDINGS Between Sept 1, 2016 and May 2, 2017, 1076 participants were randomly assigned and included in the modified intention-to-treat analysis: 271 in Group A, 267 in group B, 268 in group C, and 270 in group D. Vaccine response at 22 weeks to two doses of fIPV (group D) was significantly higher (p<0·0001) than to one dose of IPV (groups A and B) for all three poliovirus serotypes: the type 1 response comprised 212 (79% [95% CI 73-83]) versus 305 (57% [53-61]) participants, the type 2 response comprised 173 (64% [58-70]) versus 249 (46% [42-51]) participants, and the type 3 response comprised 196 (73% [67-78]) versus 196 (36% [33-41]) participants. At 26 weeks, the fIPV booster was non-inferior to IPV (group B vs group A) for serotype 1 (-1·12% [90% CI -2·18 to -0·06]), serotype 2 (0·40%, [-2·22 to 1·42]), and serotype 3 (1·51% [-3·23 to -0·21]). Of 129 adverse events, 21 were classified as serious including one death; none were attributed to IPV or fIPV. INTERPRETATION fIPV appears to be an effective dose-sparing strategy for routine immunisation and outbreak responses. FUNDING US Centers for Disease Control and Prevention.",2019,"At 26 weeks, the fIPV booster was non-inferior to IPV (group B vs group A) for serotype 1","['Healthy infants', 'two clinics in Dhaka, Bangladesh', '1076 participants', 'Between Sept 1, 2016 and May 2, 2017']","['inactivated poliovirus vaccine', 'fIPV booster was non-inferior to IPV', 'IPV', 'polio vaccines', 'fractional inactivated poliovirus vaccine (fIPV', '0·06']","['reciprocal antibody titres', 'vaccine response to poliovirus types 1, 2, and 3 at age 22 weeks (routine immunisation) and age 26 weeks (outbreak response', 'routine immunisation and outbreak response', 'Vaccine response']","[{'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0004732', 'cui_str': 'Bangladesh'}]","[{'cui': 'C0718003', 'cui_str': 'Poliovirus Vaccine, Inactivated'}, {'cui': 'C0085305', 'cui_str': 'Feline infectious peritonitis virus'}, {'cui': 'C1697762', 'cui_str': 'Booster'}, {'cui': 'C0542339', 'cui_str': 'Below (qualifier value)'}, {'cui': 'C0276240', 'cui_str': 'Infectious pustular vulvovaginitis (disorder)'}, {'cui': 'C0032371', 'cui_str': 'Poliomyelitis Infection'}, {'cui': 'C0032374', 'cui_str': 'Poliovirus Vaccines'}]","[{'cui': 'C1287242', 'cui_str': 'Finding of antibody titer (finding)'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0006322', 'cui_str': 'Human poliovirus 1'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0857208', 'cui_str': 'Routine immunization'}, {'cui': 'C0220888', 'cui_str': 'outbreaks'}]",1076.0,0.180264,"At 26 weeks, the fIPV booster was non-inferior to IPV (group B vs group A) for serotype 1","[{'ForeName': 'Cynthia J', 'Initials': 'CJ', 'LastName': 'Snider', 'Affiliation': 'US Centers for Disease Control and Prevention, Atlanta, GA, USA. Electronic address: csnider@cdc.gov.'}, {'ForeName': 'Khalequ', 'Initials': 'K', 'LastName': 'Zaman', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b), Dhaka, Bangladesh.'}, {'ForeName': 'Concepcion F', 'Initials': 'CF', 'LastName': 'Estivariz', 'Affiliation': 'US Centers for Disease Control and Prevention, Atlanta, GA, USA.'}, {'ForeName': 'Mohammad', 'Initials': 'M', 'LastName': 'Yunus', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b), Dhaka, Bangladesh.'}, {'ForeName': 'William C', 'Initials': 'WC', 'LastName': 'Weldon', 'Affiliation': 'US Centers for Disease Control and Prevention, Atlanta, GA, USA.'}, {'ForeName': 'Kathleen A', 'Initials': 'KA', 'LastName': 'Wannemuehler', 'Affiliation': 'US Centers for Disease Control and Prevention, Atlanta, GA, USA.'}, {'ForeName': 'M Steven', 'Initials': 'MS', 'LastName': 'Oberste', 'Affiliation': 'US Centers for Disease Control and Prevention, Atlanta, GA, USA.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Pallansch', 'Affiliation': 'US Centers for Disease Control and Prevention, Atlanta, GA, USA.'}, {'ForeName': 'Steven Gf', 'Initials': 'SG', 'LastName': 'Wassilak', 'Affiliation': 'US Centers for Disease Control and Prevention, Atlanta, GA, USA.'}, {'ForeName': 'Tajul Islam A', 'Initials': 'TIA', 'LastName': 'Bari', 'Affiliation': 'International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b), Dhaka, Bangladesh.'}, {'ForeName': 'Abhijeet', 'Initials': 'A', 'LastName': 'Anand', 'Affiliation': 'US Centers for Disease Control and Prevention, Atlanta, GA, USA.'}]","Lancet (London, England)",['10.1016/S0140-6736(19)30503-3'] 3230,32202637,Clinical and biological implications of target occupancy in CLL treated with the BTK inhibitor acalabrutinib.,"Inhibition of the B-cell receptor pathway, and specifically of Bruton tyrosine kinase (BTK), is a leading therapeutic strategy in B-cell malignancies, including chronic lymphocytic leukemia (CLL). Target occupancy is a measure of covalent binding to BTK and has been applied as a pharmacodynamic parameter in clinical studies of BTK inhibitors. However, the kinetics of de novo BTK synthesis, which determines occupancy, and the relationship between occupancy, pathway inhibition and clinical outcomes remain undefined. This randomized phase 2 study investigated the safety, efficacy, and pharmacodynamics of a selective BTK inhibitor acalabrutinib at 100 mg twice daily (BID) or 200 mg once daily (QD) in 48 patients with relapsed/refractory or high-risk treatment-naïve CLL. Acalabrutinib was well tolerated and yielded an overall response rate (ORR) of partial response or better of 95.8% (95% confidence interval [CI], 78.9-99.9) and an estimated progression-free survival (PFS) rate at 24 months of 91.5% (95% CI, 70.0-97.8) with BID dosing and an ORR of 79.2% (95% CI, 57.9-92.9) and an estimated PFS rate at 24 months of 87.2% (95% CI, 57.2-96.7) with QD dosing. BTK resynthesis was faster in patients with CLL than in healthy volunteers. BID dosing maintained higher BTK occupancy and achieved more potent pathway inhibition compared with QD dosing. Small increments in occupancy attained by BID dosing relative to QD dosing compounded over time to augment downstream biological effects. The impact of BTK occupancy on long-term clinical outcomes remains to be determined. This trial was registered at www.clinicaltrials.gov as #NCT02337829.",2020,"Acalabrutinib was well tolerated and yielded an overall response rate (ORR) of partial response or better of 95.8% (95% CI 78.9%, 99.9%) and an estimated progression-free survival (PFS) rate at 24 months of 91.5% (95% CI 70.0%, 97.8%) with BID dosing and an ORR of 79.2% (95% CI 57.9%, 92.9%) and an estimated PFS rate at 24 months of 87.2% (95% CI 57.2%, 96.7%) with QD dosing.","['healthy volunteers', 'chronic lymphocytic leukemia (CLL', '48 patients with relapsed/refractory or high-risk treatment naïve CLL']",['selective BTK inhibitor acalabrutinib'],"['safety, efficacy, and pharmacodynamics', 'estimated progression-free survival (PFS) rate', 'overall response rate (ORR) of partial response', 'estimated PFS rate']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0023434', 'cui_str': 'Lymphoma, Small Lymphocytic'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205269', 'cui_str': 'Intractable (qualifier value)'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C4078312', 'cui_str': 'acalabrutinib'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0728938', 'cui_str': 'Partial (qualifier value)'}]",48.0,0.0640529,"Acalabrutinib was well tolerated and yielded an overall response rate (ORR) of partial response or better of 95.8% (95% CI 78.9%, 99.9%) and an estimated progression-free survival (PFS) rate at 24 months of 91.5% (95% CI 70.0%, 97.8%) with BID dosing and an ORR of 79.2% (95% CI 57.9%, 92.9%) and an estimated PFS rate at 24 months of 87.2% (95% CI 57.2%, 96.7%) with QD dosing.","[{'ForeName': 'Clare', 'Initials': 'C', 'LastName': 'Sun', 'Affiliation': 'Hematology Branch, National Heart, Lung, and Blood Institute.'}, {'ForeName': 'Pia', 'Initials': 'P', 'LastName': 'Nierman', 'Affiliation': 'Hematology Branch, National Heart, Lung, and Blood Institute.'}, {'ForeName': 'Ellen K', 'Initials': 'EK', 'LastName': 'Kendall', 'Affiliation': 'Hematology Branch, National Heart, Lung, and Blood Institute.'}, {'ForeName': 'Jean', 'Initials': 'J', 'LastName': 'Cheung', 'Affiliation': 'Acerta Pharma, a member of the AstraZeneca Group, South San Francisco, CA.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Gulrajani', 'Affiliation': 'Acerta Pharma, a member of the AstraZeneca Group, South San Francisco, CA.'}, {'ForeName': 'Sarah E M', 'Initials': 'SEM', 'LastName': 'Herman', 'Affiliation': 'Hematology Branch, National Heart, Lung, and Blood Institute.'}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Pleyer', 'Affiliation': 'Hematology Branch, National Heart, Lung, and Blood Institute.'}, {'ForeName': 'Inhye E', 'Initials': 'IE', 'LastName': 'Ahn', 'Affiliation': 'Hematology Branch, National Heart, Lung, and Blood Institute.'}, {'ForeName': 'Maryalice', 'Initials': 'M', 'LastName': 'Stetler-Stevenson', 'Affiliation': 'Laboratory of Pathology, Center for Cancer Research, National Cancer Institute, and.'}, {'ForeName': 'Constance M', 'Initials': 'CM', 'LastName': 'Yuan', 'Affiliation': 'Laboratory of Pathology, Center for Cancer Research, National Cancer Institute, and.'}, {'ForeName': 'Irina', 'Initials': 'I', 'LastName': 'Maric', 'Affiliation': 'Hematology Section, Department of Laboratory Medicine, Clinical Center, National Institutes of Health, Bethesda, MD; and.'}, {'ForeName': 'Erika M', 'Initials': 'EM', 'LastName': 'Gaglione', 'Affiliation': 'Hematology Branch, National Heart, Lung, and Blood Institute.'}, {'ForeName': 'Hailey M', 'Initials': 'HM', 'LastName': 'Harris', 'Affiliation': 'Hematology Branch, National Heart, Lung, and Blood Institute.'}, {'ForeName': 'Stefania', 'Initials': 'S', 'LastName': 'Pittaluga', 'Affiliation': 'Laboratory of Pathology, Center for Cancer Research, National Cancer Institute, and.'}, {'ForeName': 'Min Hui', 'Initials': 'MH', 'LastName': 'Wang', 'Affiliation': 'Acerta Pharma, a member of the AstraZeneca Group, South San Francisco, CA.'}, {'ForeName': 'Priti', 'Initials': 'P', 'LastName': 'Patel', 'Affiliation': 'Acerta Pharma, a member of the AstraZeneca Group, South San Francisco, CA.'}, {'ForeName': 'Mohammed Z H', 'Initials': 'MZH', 'LastName': 'Farooqui', 'Affiliation': 'Hematology Branch, National Heart, Lung, and Blood Institute.'}, {'ForeName': 'Raquel', 'Initials': 'R', 'LastName': 'Izumi', 'Affiliation': 'Acerta Pharma, a member of the AstraZeneca Group, South San Francisco, CA.'}, {'ForeName': 'Ahmed', 'Initials': 'A', 'LastName': 'Hamdy', 'Affiliation': 'Acerta Pharma, a member of the AstraZeneca Group, South San Francisco, CA.'}, {'ForeName': 'Todd', 'Initials': 'T', 'LastName': 'Covey', 'Affiliation': 'Acerta Pharma, a member of the AstraZeneca Group, South San Francisco, CA.'}, {'ForeName': 'Adrian', 'Initials': 'A', 'LastName': 'Wiestner', 'Affiliation': 'Hematology Branch, National Heart, Lung, and Blood Institute.'}]",Blood,['10.1182/blood.2019003715'] 3231,31923137,Predictors of Sexually Transmitted Infection Positivity Among Substance-Using Native American Adults.,"BACKGROUND Sexually transmitted infections (STIs) are a public health crisis with Native Americans suffering a high burden of disease. Studies across gender and racial/ethnic groups have found varying risk factors associated with STI positivity. Understanding how risk factors are associated with STI positivity can help design interventions for those most at risk. METHODS Participants were Native American binge substance using adults enrolled in a randomized controlled trial evaluating a brief intervention to increase STI screening and reduce sexual risk-taking behaviors. Participants completed a self-report assessment at baseline that included questions about sexual risk factors and STI testing behaviors and diagnosis. This analysis includes those who had ever completed an STI test at baseline. Bivariate and multivariate analyses using logistical regression were utilized to identify associations between risk factors and past STI diagnosis. RESULTS A total of 193 people were included in the analysis. Over half (50.6%) of the participants had ever been diagnosed with an STI. Risk behaviors varied by gender. More women with a self-reported history of STI reported having sex with someone they thought had an STI, past experience of physical/sexual violence, and having passed out from drinking. Men with a self-reported history of STI were more likely to report past marijuana and other drug use. Among women with a self-reported history of STI, having sex with someone they thought had an STI was associated with STI positivity, whereas other drug use was associated with STI positivity among men with a self-reported history of STI. CONCLUSIONS Findings provide information for those working to reduce STIs in Native Communities to better identify and design programs for those at highest risk for STIs. Additional studies examining gender dynamics and sexual risk taking among native adults are warranted.",2020,"More women with a self-reported history of STI reported having sex with someone they thought had an STI, past experience of physical/sexual violence and having passed out from drinking.","['Substance Using Native American Adults', 'Sexually Transmitted Infections (STIs) are a public health crisis with Native Americans suffering a high burden of disease', 'Men with a self-reported history of STI', 'A total of 193 people were included in the analysis', 'Participants were Native American binge substance using adults enrolled']",['brief intervention to increase STI screening'],"['sexual risk-taking behaviors', 'Risk behaviors', 'STI positivity']","[{'cui': 'C0237123', 'cui_str': 'Substance use'}, {'cui': 'C0282204', 'cui_str': 'Native Americans'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0036916', 'cui_str': 'STDs'}, {'cui': 'C1292718', 'cui_str': 'Is a'}, {'cui': 'C0034019', 'cui_str': 'Community Health'}, {'cui': 'C0231224', 'cui_str': 'Crisis (finding)'}, {'cui': 'C0302891', 'cui_str': 'Native (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0596170', 'cui_str': 'Binge overeating'}]","[{'cui': 'C1879313', 'cui_str': 'Brief (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0036916', 'cui_str': 'STDs'}, {'cui': 'C0220908', 'cui_str': 'Screening'}]","[{'cui': 'C0035651', 'cui_str': 'Risk-Taking'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0086931', 'cui_str': 'Risk Behavior'}, {'cui': 'C0036916', 'cui_str': 'STDs'}]",193.0,0.0841178,"More women with a self-reported history of STI reported having sex with someone they thought had an STI, past experience of physical/sexual violence and having passed out from drinking.","[{'ForeName': 'Rachel Strom', 'Initials': 'RS', 'LastName': 'Chambers', 'Affiliation': 'From the Johns Hopkins Center for American Indian Health.'}, {'ForeName': 'Shea', 'Initials': 'S', 'LastName': 'Littlepage', 'Affiliation': 'From the Johns Hopkins Center for American Indian Health.'}, {'ForeName': 'Anne', 'Initials': 'A', 'LastName': 'Rompalo', 'Affiliation': 'Johns Hopkins School of Medicine, Johns Hopkins University, Baltimore, MD.'}, {'ForeName': 'Angelita', 'Initials': 'A', 'LastName': 'Lee', 'Affiliation': 'From the Johns Hopkins Center for American Indian Health.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Slimp', 'Affiliation': 'From the Johns Hopkins Center for American Indian Health.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Melgar', 'Affiliation': 'From the Johns Hopkins Center for American Indian Health.'}, {'ForeName': 'Mariddie', 'Initials': 'M', 'LastName': 'Craig', 'Affiliation': 'White Mountain Apache Tribe, Whiteriver, AZ.'}, {'ForeName': 'Charlotte', 'Initials': 'C', 'LastName': 'Gaydos', 'Affiliation': 'Johns Hopkins School of Medicine, Johns Hopkins University, Baltimore, MD.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'Tingey', 'Affiliation': 'From the Johns Hopkins Center for American Indian Health.'}]",Sexually transmitted diseases,['10.1097/OLQ.0000000000001129'] 3232,32168305,Hypothermia Plus Melatonin in Asphyctic Newborns: A Randomized-Controlled Pilot Study.,"OBJECTIVES To investigate the effect of adding melatonin to hypothermia treatment on neurodevelopmental outcomes in asphyctic newborns. DESIGN Pilot multicenter, randomized, controlled, double-blind clinical trial. Statistical comparison of results obtained in two intervention arms: hypothermia plus placebo and hypothermia plus melatonin. SETTING Level 3 neonatal ICU. PATIENTS Twenty-five newborns were recruited. INTERVENTIONS The hypothermia plus melatonin patients received a daily dose of IV melatonin, 5 mg per kg body weight, for 3 days. General laboratory variables were measured both at neonatal ICU admission and after intervention. All infants were studied with amplitude-integrated electroencephalography and brain MRI within the first week of life. The neurodevelopmental Bayley III test, the Gross Motor Function Classification System, and the Tardieu scale were applied at the ages of 6 and 18 months. MEASUREMENTS AND MAIN RESULTS Clinical characteristics, laboratory evaluations, MRI findings, and amplitude-integrated electroencephalography background did not differ between the treatment groups. The newborns in the hypothermia plus melatonin group achieved a significantly higher composite score for the cognitive section of the Bayley III test at 18 months old, with respect to the hypothermia plus placebo group (p = 0.05). There were no differences between the groups according to the Gross Motor Function Classification System and Tardieu motor assessment scales. CONCLUSIONS The early addition of IV melatonin to asphyctic neonates is feasible and may improve long-term neurodevelopment. To our knowledge, this is the first clinical trial to analyze the administration of IV melatonin as an adjuvant therapy to therapeutic hypothermia.",2020,"The newborns in the hypothermia plus melatonin group achieved a significantly higher composite score for the cognitive section of the Bayley III test at 18 months old, with respect to the hypothermia plus placebo group (p = 0.05).","['Asphyctic Newborns', 'asphyctic newborns', 'Twenty-five newborns were recruited', 'Level 3 neonatal ICU']","['hypothermia plus placebo', 'IV melatonin', 'hypothermia plus melatonin', 'melatonin', 'Hypothermia Plus Melatonin']","['Gross Motor Function Classification System and Tardieu motor assessment scales', 'neurodevelopmental Bayley III test, the Gross Motor Function Classification System, and the Tardieu scale', 'Clinical characteristics, laboratory evaluations, MRI findings, and amplitude-integrated electroencephalography background', 'composite score', 'neurodevelopmental outcomes']","[{'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0456949', 'cui_str': 'Level 3 (qualifier value)'}, {'cui': 'C0021709', 'cui_str': 'Newborn ICU'}]","[{'cui': 'C0413252', 'cui_str': 'Hypothermia due to exposure'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0025219', 'cui_str': 'Melatonin'}]","[{'cui': 'C0677549', 'cui_str': 'Gross motor functions (observable entity)'}, {'cui': 'C0008902', 'cui_str': 'Systematics'}, {'cui': 'C0451321', 'cui_str': 'Motor assessment scale (assessment scale)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C2607943', 'cui_str': 'findings'}, {'cui': 'C0013819', 'cui_str': 'EEG'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",25.0,0.157979,"The newborns in the hypothermia plus melatonin group achieved a significantly higher composite score for the cognitive section of the Bayley III test at 18 months old, with respect to the hypothermia plus placebo group (p = 0.05).","[{'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Jerez-Calero', 'Affiliation': 'All authors: Department of Paediatrics, San Cecilio University Hospital, Granada, Spain.'}, {'ForeName': 'Maria Teresa', 'Initials': 'MT', 'LastName': 'Salvatierra-Cuenca', 'Affiliation': ''}, {'ForeName': 'Ángela', 'Initials': 'Á', 'LastName': 'Benitez-Feliponi', 'Affiliation': ''}, {'ForeName': 'Carmen Elisabeth', 'Initials': 'CE', 'LastName': 'Fernández-Marín', 'Affiliation': ''}, {'ForeName': 'Eduardo', 'Initials': 'E', 'LastName': 'Narbona-López', 'Affiliation': ''}, {'ForeName': 'José', 'Initials': 'J', 'LastName': 'Uberos-Fernández', 'Affiliation': ''}, {'ForeName': 'Antonio', 'Initials': 'A', 'LastName': 'Muñoz-Hoyos', 'Affiliation': ''}]",Pediatric critical care medicine : a journal of the Society of Critical Care Medicine and the World Federation of Pediatric Intensive and Critical Care Societies,['10.1097/PCC.0000000000002346'] 3233,32169887,"Dietary Advanced Glycation End-products (AGE) and Risk of Breast Cancer in the Prostate, Lung, Colorectal and Ovarian Cancer Screening Trial (PLCO).","Advanced glycation end-products (AGEs) are implicated in the pathogenesis of several chronic diseases including cancer. AGEs are produced endogenously but can also be consumed from foods. AGE formation in food is accelerated during cooking at high temperatures. Certain high fat or highly processed foods have high AGE values. The objective of the study was to assign and quantify N ϵ -carboxymethyl-lysine (CML)-AGE content in food and investigate the association between dietary AGE intake and breast cancer risk in the Prostate, Lung, Colorectal and Ovarian Cancer Screening Trial. The study included women enrolled in the intervention arm who were cancer-free at baseline and completed a baseline questionnaire and food frequency questionnaire (DQX). CML-AGE values were assigned and quantified to foods in the DQX using a published AGE database. Cox proportional hazards models were used to estimate the hazard ratios (HR) and 95% confidence intervals (CI) of breast cancer among all women, and stratified by race/ethnicity, invasiveness of disease, and hormone receptor status. After a median 11.5 years of follow-up, 1,592 women were diagnosed with breast cancer. Higher CML-AGE intake was associated with increased risk of breast cancer among all women (HR Q5VSQ1 , 1.30; 95% CI, 1.04-1.62; P trend = 0.04) and in non-Hispanic white women (HR T3VST1 , 1.21; 95% CI, 1.02-1.44). Increased CML-AGE intake was associated with increased risk of in situ (HR T3VST1 , 1.49; 95% CI, 1.11-2.01) and hormone receptor-positive (HR T3VST1 , 1.24; 95% CI, 1.01-1.53) breast cancers. In conclusion, high intake of dietary AGE may contribute to increased breast cancer.",2020,"Higher CML-AGE intake was associated with increased risk of breast cancer among all women (HRQ5 VS Q1:1.30, 95% CI: 1.04-1.62; P-trend: 0.04) and in non-Hispanic white women (HRT3 VS T1: 1.21, 95% CI: 1.02-1.44).","['1,592 women were diagnosed with breast cancer', 'women enrolled in the intervention arm who were cancer-free at baseline and completed a']",[],"['hormone receptor positive (HRT3 VS T1', 'Increased CML-AGE intake', 'risk of breast cancer', 'baseline questionnaire and food frequency questionnaire (DQX']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}]",[],"[{'cui': 'C0019932', 'cui_str': 'Hormones'}, {'cui': 'C0597357', 'cui_str': 'Receptor (substance)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0023473', 'cui_str': 'Leukemia, Granulocytic, Chronic'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}]",1592.0,0.0530889,"Higher CML-AGE intake was associated with increased risk of breast cancer among all women (HRQ5 VS Q1:1.30, 95% CI: 1.04-1.62; P-trend: 0.04) and in non-Hispanic white women (HRT3 VS T1: 1.21, 95% CI: 1.02-1.44).","[{'ForeName': 'Omonefe O', 'Initials': 'OO', 'LastName': 'Omofuma', 'Affiliation': 'Department of Epidemiology and Biostatistics, Arnold School of Public Health, University of South Carolina, Columbia, South Carolina.'}, {'ForeName': 'David P', 'Initials': 'DP', 'LastName': 'Turner', 'Affiliation': 'Medical University of South Carolina, Charleston, South Carolina.'}, {'ForeName': 'Lindsay L', 'Initials': 'LL', 'LastName': 'Peterson', 'Affiliation': 'Department of Medicine, Washington University School of Medicine, St. Louis, Missouri.'}, {'ForeName': 'Anwar T', 'Initials': 'AT', 'LastName': 'Merchant', 'Affiliation': 'Department of Epidemiology and Biostatistics, Arnold School of Public Health, University of South Carolina, Columbia, South Carolina.'}, {'ForeName': 'Jiajia', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Epidemiology and Biostatistics, Arnold School of Public Health, University of South Carolina, Columbia, South Carolina.'}, {'ForeName': 'Susan E', 'Initials': 'SE', 'LastName': 'Steck', 'Affiliation': 'Department of Epidemiology and Biostatistics, Arnold School of Public Health, University of South Carolina, Columbia, South Carolina. stecks@mailbox.sc.edu.'}]","Cancer prevention research (Philadelphia, Pa.)",['10.1158/1940-6207.CAPR-19-0457'] 3234,31843266,"Safety and immunogenicity of a novel 10-valent pneumococcal conjugate vaccine candidate in adults, toddlers, and infants in The Gambia-Results of a phase 1/2 randomized, double-blinded, controlled trial.","BACKGROUND A more affordable pneumococcal conjugate vaccine (PCV) that provides comparable protection to current PCVs is needed to ensure sustainable access in resource-limited settings. Serum Institute of India Pvt. Ltd.'s PCV candidate (SIIPL-PCV) has the potential to meet this need as manufacturing efficiency has been optimized and the vaccine targets the most prevalent disease-causing serotypes in Africa and Asia. We report SIIPL-PCV's safety, tolerability, and immunogenicity in adults, toddlers, and infants in The Gambia. METHODS This phase 1/2, randomized, double-blind trial sequentially enrolled 34 PCV-naive adults (18-40 years old), 112 PCV (Prevenar 13® [PCV13])-primed toddlers (12-15 months old), and 200 PCV-naive infants (6-8 weeks old), who were randomized (1:1) to receive SIIPL-PCV or a licensed comparator vaccine. Infants received three-doses of SIIPL-PCV or PCV13 at 6, 10, and 14 weeks of age co-administered with routine Expanded Program on Immunization (EPI) vaccines. Reactogenicity was solicited through seven-days post-vaccination; unsolicited adverse events (AEs) were assessed throughout the study. The safety and immunogenicity of a matching booster at 10-14 months of age were evaluated in a subset of 96 infants. Immune responses were evaluated post-primary and pre- and post-booster vaccinations. RESULTS Reactogenicity was primarily mild-to-moderate in severity. In infants, the most common solicited reactions were injection-site tenderness and fever, with no meaningful treatment-group differences. There were no serious or severe vaccine-related AEs and no meaningful trends in SAEs, vaccine-related AEs, or overall AEs. Infant post-primary seroresponse rates (IgG level ≥ 0.35 µg/mL) were ≥89% for all serotypes except 6A (79%) in the SIIPL-PCV group. IgG GMCs were >1 µg/mL for all serotypes in both SIIPL-PCV and PCV13 groups. Post-booster GMCs were comparable between groups. CONCLUSION SIIPL-PCV was well-tolerated, had an acceptable safety profile, and was immunogenic for all vaccine serotypes. Results support the evaluation of SIIPL-PCV in a phase 3 non-inferiority trial. Clinicaltrials.gov: NCT02308540.",2020,"There were no serious or severe vaccine-related AEs and no meaningful trends in SAEs, vaccine-related AEs, or overall AEs.","['adults, toddlers, and infants in The Gambia', '96 infants', '34 PCV-naive adults (18-40\u202fyears old), 112 PCV (Prevenar 13® [PCV13])-primed toddlers (12-15\u202fmonths old), and 200 PCV-naive infants (6-8\u202fweeks old']","['SIIPL-PCV or PCV13', 'SIIPL-PCV or a licensed comparator vaccine', 'routine Expanded Program on Immunization (EPI) vaccines', 'novel 10-valent pneumococcal conjugate vaccine candidate']","['Reactogenicity', 'Safety and immunogenicity', 'serious or severe vaccine-related AEs and no meaningful trends in SAEs, vaccine-related AEs, or overall AEs', 'Immune responses', 'safety and immunogenicity']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0682053', 'cui_str': 'Toddler (qualifier value)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0016993', 'cui_str': 'Republic of the Gambia'}, {'cui': 'C0018935', 'cui_str': 'Erythrocyte Volume, Packed'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C4319548', 'cui_str': '112'}, {'cui': 'C2756364', 'cui_str': 'Prevnar 13'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C0018935', 'cui_str': 'Erythrocyte Volume, Packed'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0205229', 'cui_str': 'Expanding (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0020971', 'cui_str': 'Sensitization, Immunologic'}, {'cui': 'C3849486', 'cui_str': 'ten-valent PCV'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0040833', 'cui_str': 'trends'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0301872', 'cui_str': 'Immune response, function (observable entity)'}]",34.0,0.593895,"There were no serious or severe vaccine-related AEs and no meaningful trends in SAEs, vaccine-related AEs, or overall AEs.","[{'ForeName': 'Ed', 'Initials': 'E', 'LastName': 'Clarke', 'Affiliation': 'Medical Research Council (MRC) Unit The Gambia at the London School of Hygiene and Tropical Medicine, Atlantic Road, Fajara, PO Box 273, Banjul, Gambia. Electronic address: Ed.Clarke@lshtm.ac.uk.'}, {'ForeName': 'Adedapo O', 'Initials': 'AO', 'LastName': 'Bashorun', 'Affiliation': 'Medical Research Council (MRC) Unit The Gambia at the London School of Hygiene and Tropical Medicine, Atlantic Road, Fajara, PO Box 273, Banjul, Gambia.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Okoye', 'Affiliation': 'Medical Research Council (MRC) Unit The Gambia at the London School of Hygiene and Tropical Medicine, Atlantic Road, Fajara, PO Box 273, Banjul, Gambia.'}, {'ForeName': 'Ama', 'Initials': 'A', 'LastName': 'Umesi', 'Affiliation': 'Medical Research Council (MRC) Unit The Gambia at the London School of Hygiene and Tropical Medicine, Atlantic Road, Fajara, PO Box 273, Banjul, Gambia.'}, {'ForeName': 'Mariama', 'Initials': 'M', 'LastName': 'Badjie Hydara', 'Affiliation': 'Medical Research Council (MRC) Unit The Gambia at the London School of Hygiene and Tropical Medicine, Atlantic Road, Fajara, PO Box 273, Banjul, Gambia.'}, {'ForeName': 'Ikechukwu', 'Initials': 'I', 'LastName': 'Adigweme', 'Affiliation': 'Medical Research Council (MRC) Unit The Gambia at the London School of Hygiene and Tropical Medicine, Atlantic Road, Fajara, PO Box 273, Banjul, Gambia.'}, {'ForeName': 'Rajeev', 'Initials': 'R', 'LastName': 'Dhere', 'Affiliation': 'Serum Institute of India Pvt. Ltd., 212/2, Off Soli Poonawalla Road Hadapsar, Pune 411028, India.'}, {'ForeName': 'Vistasp', 'Initials': 'V', 'LastName': 'Sethna', 'Affiliation': 'Serum Institute of India Pvt. Ltd., 212/2, Off Soli Poonawalla Road Hadapsar, Pune 411028, India.'}, {'ForeName': 'Beate', 'Initials': 'B', 'LastName': 'Kampmann', 'Affiliation': 'Medical Research Council (MRC) Unit The Gambia at the London School of Hygiene and Tropical Medicine, Atlantic Road, Fajara, PO Box 273, Banjul, Gambia; Vaccine Centre, Faculty of Infectious and Tropical Diseases, London School of Hygiene and Tropical Medicine, Keppel Street, London, United Kingdom.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Goldblatt', 'Affiliation': 'Great Ormond Street Institute of Child Health Biomedical Research Centre, University College London, 30 Guilford Street, London, United Kingdom.'}, {'ForeName': 'Andi', 'Initials': 'A', 'LastName': 'Tate', 'Affiliation': 'PATH, 2201 Westlake Avenue, Suite 200, Seattle, WA, USA.'}, {'ForeName': 'Debra H', 'Initials': 'DH', 'LastName': 'Weiner', 'Affiliation': 'FHI 360, 359 Blackwell Street, Suite 200, Durham, NC, USA.'}, {'ForeName': 'Jorge', 'Initials': 'J', 'LastName': 'Flores', 'Affiliation': 'PATH, 2201 Westlake Avenue, Suite 200, Seattle, WA, USA.'}, {'ForeName': 'Mark R', 'Initials': 'MR', 'LastName': 'Alderson', 'Affiliation': 'PATH, 2201 Westlake Avenue, Suite 200, Seattle, WA, USA.'}, {'ForeName': 'Steve', 'Initials': 'S', 'LastName': 'Lamola', 'Affiliation': 'PATH, 2201 Westlake Avenue, Suite 200, Seattle, WA, USA.'}]",Vaccine,['10.1016/j.vaccine.2019.08.072'] 3235,31987664,Outcome of pitavastatin versus atorvastatin therapy in patients with hypercholesterolemia at high risk for atherosclerotic cardiovascular disease.,"BACKGROUND There has been no report about outcome of pitavastatin versus atorvastatin therapy in high-risk patients with hypercholesterolemia. METHODS Hypercholesterolemic patients with one or more risk factors for atherosclerotic diseases (n = 664, age = 65, male = 54%, diabetes = 76%, primary prevention = 74%) were randomized to receive pitavastatin 2 mg/day (n = 332) or atorvastatin 10 mg/day (n = 332). Follow-up period was 240 weeks. The primary end point was a composite of cardiovascular death, sudden death of unknown origin, nonfatal myocardial infarction, nonfatal stroke, transient ischemic attack, or heart failure requiring hospitalization. The secondary end point was a composite of the primary end point plus clinically indicated coronary revascularization for stable angina. RESULTS The mean low-density lipoprotein cholesterol (LDL-C) level at baseline was 149 mg/dL. The mean LDL-C levels at 1 year were 95 mg/dL in the pitavastatin group and 94 mg/dL in the atorvastatin group. There were no differences in LDL-C levels between both groups, however, pitavastatin significantly reduced the risk of the primary end point, compared to atorvastatin (pitavastatin = 2.9% and atorvastatin = 8.1%, HR, 0.366; 95% CI 0.170-0.787; P = 0.01 by multivariate Cox regression) as well as the risk of the secondary end point (pitavastatin = 4.5% and atorvastatin = 12.9%, HR = 0.350; 95%CI = 0.189-0.645, P = 0.001). The results for the primary and secondary end points were consistent across several prespecified subgroups. There were no differences in incidence of adverse events between the statins. CONCLUSION Pitavastatin therapy compared with atorvastatin more may prevent cardiovascular events in hypercholesterolemic patients with one or more risk factors for atherosclerotic diseases despite similar effects on LDL-C levels.",2020,"There were no differences in LDL-C levels between both groups, however, pitavastatin significantly reduced the risk of the primary end point, compared to atorvastatin (pitavastatin = 2.9% and atorvastatin = 8.1%, HR, 0.366; 95% CI 0.170-0.787; P = 0.01 by multivariate Cox regression) as well as the risk of the secondary end point (pitavastatin = 4.5% and atorvastatin = 12.9%, HR = 0.350; 95%CI = ","['patients with hypercholesterolemia at high risk for atherosclerotic cardiovascular disease', 'high-risk patients with hypercholesterolemia', 'hypercholesterolemic patients', '65, male\xa0=\xa054%, diabetes\xa0=\xa076%, primary prevention\xa0=\xa074', 'Hypercholesterolemic patients with one or more risk factors for atherosclerotic diseases (n\xa0=\xa0664, age\xa0']","['pitavastatin', 'atorvastatin therapy', 'atorvastatin', 'Pitavastatin therapy', 'atorvastatin (pitavastatin']","['composite of cardiovascular death, sudden death of unknown origin, nonfatal myocardial infarction, nonfatal stroke, transient ischemic attack, or heart failure requiring hospitalization', 'cardiovascular events', 'incidence of adverse events', 'LDL-C levels', 'mean LDL-C levels', 'mean low-density lipoprotein cholesterol (LDL-C) level', 'coronary revascularization for stable angina']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0020443', 'cui_str': 'High Cholesterol Levels'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0004153', 'cui_str': 'Atherosclerosis'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0033144', 'cui_str': 'Disease Prevention, Primary'}, {'cui': 'C0035648', 'cui_str': 'Risk factor (observable entity)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}]","[{'cui': 'C1101838', 'cui_str': 'pitavastatin'}, {'cui': 'C0286651', 'cui_str': 'atorvastatin'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0011071', 'cui_str': 'Sudden death (event)'}, {'cui': 'C0439673', 'cui_str': 'Unknown (qualifier value)'}, {'cui': 'C0439659', 'cui_str': 'Origins (qualifier value)'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0007787', 'cui_str': 'Brain TIA'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C1320716', 'cui_str': 'Cardiovascular event'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0023823', 'cui_str': 'beta-Lipoproteins'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0202117', 'cui_str': 'Low density lipoprotein cholesterol measurement (procedure)'}, {'cui': 'C0877341', 'cui_str': 'Coronary revascularisation'}, {'cui': 'C0340288', 'cui_str': 'Angina Pectoris, Stable'}]",,0.0208859,"There were no differences in LDL-C levels between both groups, however, pitavastatin significantly reduced the risk of the primary end point, compared to atorvastatin (pitavastatin = 2.9% and atorvastatin = 8.1%, HR, 0.366; 95% CI 0.170-0.787; P = 0.01 by multivariate Cox regression) as well as the risk of the secondary end point (pitavastatin = 4.5% and atorvastatin = 12.9%, HR = 0.350; 95%CI = ","[{'ForeName': 'Masao', 'Initials': 'M', 'LastName': 'Moroi', 'Affiliation': 'Division of Cardiovascular Medicine (Ohashi), Department of Internal Medicine, Faculty of Medicine, Toho University, Tokyo, Japan. Electronic address: moroi@med.toho-u.ac.jp.'}, {'ForeName': 'Daiji', 'Initials': 'D', 'LastName': 'Nagayama', 'Affiliation': 'Nagayama Clinic, Oyama City, Tochigi, Japan.'}, {'ForeName': 'Fumihiko', 'Initials': 'F', 'LastName': 'Hara', 'Affiliation': 'Division of Cardiovascular Medicine (Omori), Department of Internal Medicine, Faculty of Medicine, Toho University, Tokyo, Japan.'}, {'ForeName': 'Atsuhito', 'Initials': 'A', 'LastName': 'Saiki', 'Affiliation': 'Division of Diabetes, Endocrinology and Metabolism (Sakura), Department of Internal Medicine, Faculty of Medicine, Toho University, Chiba, Japan.'}, {'ForeName': 'Kazuhiro', 'Initials': 'K', 'LastName': 'Shimizu', 'Affiliation': 'Division of Cardiovascular Medicine (Sakura), Department of Internal Medicine, Faculty of Medicine, Toho University, Chiba, Japan.'}, {'ForeName': 'Mao', 'Initials': 'M', 'LastName': 'Takahashi', 'Affiliation': 'Division of Cardiovascular Medicine (Sakura), Department of Internal Medicine, Faculty of Medicine, Toho University, Chiba, Japan.'}, {'ForeName': 'Naoko', 'Initials': 'N', 'LastName': 'Sato', 'Affiliation': 'Pharmaceutical Unit, Toho University Sakura Medical Center, Chiba, Japan.'}, {'ForeName': 'Teruo', 'Initials': 'T', 'LastName': 'Shiba', 'Affiliation': 'Division of Diabetes and Metabolism (Ohashi), Department of Internal Medicine, Faculty of Medicine, Toho University, Tokyo, Japan.'}, {'ForeName': 'Hideki', 'Initials': 'H', 'LastName': 'Sugimoto', 'Affiliation': 'Division of Neurology (Ohashi), Department of Internal Medicine, Faculty of Medicine, Toho University, Tokyo, Japan.'}, {'ForeName': 'Toshiki', 'Initials': 'T', 'LastName': 'Fujioka', 'Affiliation': 'Division of Neurology (Ohashi), Department of Internal Medicine, Faculty of Medicine, Toho University, Tokyo, Japan.'}, {'ForeName': 'Tatsuo', 'Initials': 'T', 'LastName': 'Chiba', 'Affiliation': 'Department of Pharmacy, Toho University Omori Medical Center, Tokyo, Japan.'}, {'ForeName': 'Kosuke', 'Initials': 'K', 'LastName': 'Nishizawa', 'Affiliation': 'Department of Pharmacy, Toho University Omori Medical Center, Tokyo, Japan.'}, {'ForeName': 'Shuki', 'Initials': 'S', 'LastName': 'Usui', 'Affiliation': 'Division of Diabetes, Endocrinology and Metabolism (Omori), Department of Internal Medicine, Faculty of Medicine, Toho University, Tokyo, Japan.'}, {'ForeName': 'Yasuo', 'Initials': 'Y', 'LastName': 'Iwasaki', 'Affiliation': 'Division of Neurology (Omori), Department of Internal Medicine, Faculty of Medicine, Toho University, Tokyo, Japan.'}, {'ForeName': 'Ichiro', 'Initials': 'I', 'LastName': 'Tatsuno', 'Affiliation': 'Division of Diabetes, Endocrinology and Metabolism (Sakura), Department of Internal Medicine, Faculty of Medicine, Toho University, Chiba, Japan.'}, {'ForeName': 'Kaoru', 'Initials': 'K', 'LastName': 'Sugi', 'Affiliation': 'Division of Cardiovascular Medicine (Ohashi), Department of Internal Medicine, Faculty of Medicine, Toho University, Tokyo, Japan.'}, {'ForeName': 'Junichi', 'Initials': 'J', 'LastName': 'Yamasaki', 'Affiliation': 'Division of Cardiovascular Medicine (Omori), Department of Internal Medicine, Faculty of Medicine, Toho University, Tokyo, Japan.'}, {'ForeName': 'Shigeo', 'Initials': 'S', 'LastName': 'Yamamura', 'Affiliation': 'Faculty of Pharmaceutical Sciences, Josai International University, Chiba, Japan.'}, {'ForeName': 'Kohji', 'Initials': 'K', 'LastName': 'Shirai', 'Affiliation': 'Division of Diabetes, Endocrinology and Metabolism (Sakura), Department of Internal Medicine, Faculty of Medicine, Toho University, Chiba, Japan.'}]",International journal of cardiology,['10.1016/j.ijcard.2020.01.006'] 3236,32087610,Pilot randomized controlled trial of a video self-help intervention for depression based on acceptance and commitment therapy: Feasibility and acceptability.,"A common setting where depression is identified and treated is in primary care, where there is a need for low-intensity and cost-effective interventions to be used as part of a stepped-care model. The current study involved a pilot, parallel-group, randomized controlled trial of a video self-help intervention for primary care patients based on acceptance and commitment therapy (ACT). The intervention, called LifeStories, consisted of storytelling vignettes of patients describing their use of ACT-consistent coping skills for depression. Primary care patients were recruited to determine feasibility, acceptability, and potential clinical effects of the intervention. Twenty-one participants were assigned to use LifeStories over a period of 4 weeks, and 19 participants were assigned to an attention-matched comparison group. Qualitative feedback indicated that participants using LifeStories found the intervention to be engaging and useful in transmitting key ACT principles. Furthermore, those receiving LifeStories rated their level of ""transportation"" or immersion in the videos higher than the control group. Both conditions showed large improvements in levels of depression at a 12-week follow-up. There were no significant differences in symptom outcomes between groups; however, because this was a pilot study, it was not powered to detect differences between interventions. Both conditions additionally showed smaller effect size changes in psychological flexibility, a key ACT mechanism. The results suggest LifeStories to be a feasible and acceptable psychological intervention that may improve depression, and further research is warranted to determine its effectiveness as part of a stepped-care approach to treating depression in primary care.",2020,"Furthermore, those receiving LifeStories rated their level of ""transportation"" or immersion in the videos higher than the control group.","['A total of 21 participants', 'Primary care patients', 'primary care patients based on Acceptance and Commitment Therapy (ACT']","['ACT-consistent coping skills', 'Video Self-Help Intervention', 'video self-help intervention']","['symptom outcomes', 'psychological flexibility', 'levels of depression']","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C3658321', 'cui_str': 'Acceptance and Commitment Therapy'}]","[{'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0036588', 'cui_str': 'Self'}]","[{'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0205486', 'cui_str': 'Psychologic (qualifier value)'}, {'cui': 'C0242808', 'cui_str': 'Flexibility'}, {'cui': 'C1319226', 'cui_str': 'Level of depression'}]",21.0,0.0716519,"Furthermore, those receiving LifeStories rated their level of ""transportation"" or immersion in the videos higher than the control group.","[{'ForeName': 'Brandon A', 'Initials': 'BA', 'LastName': 'Gaudiano', 'Affiliation': 'Psychosocial Research Program, Butler Hospital, Providence, Rhode Island.'}, {'ForeName': 'Carter H', 'Initials': 'CH', 'LastName': 'Davis', 'Affiliation': 'Department of Psychology, Utah State University, Logan, Utah.'}, {'ForeName': 'Ivan W', 'Initials': 'IW', 'LastName': 'Miller', 'Affiliation': 'Psychosocial Research Program, Butler Hospital, Providence, Rhode Island.'}, {'ForeName': 'Lisa', 'Initials': 'L', 'LastName': 'Uebelacker', 'Affiliation': 'Psychosocial Research Program, Butler Hospital, Providence, Rhode Island.'}]",Clinical psychology & psychotherapy,['10.1002/cpp.2436'] 3237,32089356,Strategies to Improve Recruitment to a De-escalation Trial: A Mixed-Methods Study of the OPTIMA Prelim Trial in Early Breast Cancer.,"AIMS De-escalation trials are challenging and sometimes may fail due to poor recruitment. The OPTIMA Prelim randomised controlled trial (ISRCTN42400492) randomised patients with early stage breast cancer to chemotherapy versus 'test-directed' chemotherapy, with a possible outcome of no chemotherapy, which could confer less treatment relative to routine practice. Despite encountering challenges, OPTIMA Prelim reached its recruitment target ahead of schedule. This study reports the root causes of recruitment challenges and the strategies used to successfully overcome them. MATERIALS AND METHODS A mixed-methods recruitment intervention (QuinteT Recruitment Intervention) was used to investigate the recruitment difficulties and feedback findings to inform interventions and optimise ongoing recruitment. Quantitative site-level recruitment data, audio-recorded recruitment appointments (n = 46), qualitative interviews (n = 22) with trialists/recruiting staff (oncologists/nurses) and patient-facing documentation were analysed using descriptive, thematic and conversation analyses. Findings were triangulated to inform a 'plan of action' to optimise recruitment. RESULTS Despite best intentions, oncologists' routine practices complicated recruitment. Discomfort about deviating from the usual practice of recommending chemotherapy according to tumour clinicopathological features meant that not all eligible patients were approached. Audio-recorded recruitment appointments revealed how routine practices undermined recruitment. A tendency to justify chemotherapy provision before presenting the randomised controlled trial and subtly indicating that chemotherapy would be more/less beneficial undermined equipoise and made it difficult for patients to engage with OPTIMA Prelim. To tackle these challenges, individual and group recruiter feedback focussed on communication issues and vignettes of eligible patients were discussed to address discomforts around approaching patients. 'Tips' documents concerning structuring discussions and conveying equipoise were disseminated across sites, together with revisions to the Patient Information Sheet. CONCLUSIONS This is the first study illuminating the tension between oncologists' routine practices and recruitment to de-escalation trials. Although time and resources are required, these challenges can be addressed through specific feedback and training as the trial is underway.",2020,"The OPTIMA Prelim randomised controlled trial (ISRCTN42400492) randomised patients with early stage breast cancer to chemotherapy versus 'test-directed' chemotherapy, with a possible outcome of no chemotherapy, which could confer less treatment relative to routine practice.","['Early Breast Cancer', 'patients with early stage breast cancer to']","[""chemotherapy versus 'test-directed' chemotherapy"", 'mixed-methods recruitment intervention (QuinteT Recruitment Intervention']",[],"[{'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2363430', 'cui_str': 'Early stage (qualifier value)'}]","[{'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0271510', 'cui_str': 'Recruitment (disorder)'}]",[],,0.0681037,"The OPTIMA Prelim randomised controlled trial (ISRCTN42400492) randomised patients with early stage breast cancer to chemotherapy versus 'test-directed' chemotherapy, with a possible outcome of no chemotherapy, which could confer less treatment relative to routine practice.","[{'ForeName': 'C', 'Initials': 'C', 'LastName': 'Conefrey', 'Affiliation': 'Population Health Sciences, University of Bristol, Bristol, UK. Electronic address: carmel.conefrey@bristol.ac.uk.'}, {'ForeName': 'J L', 'Initials': 'JL', 'LastName': 'Donovan', 'Affiliation': 'Population Health Sciences, University of Bristol, Bristol, UK.'}, {'ForeName': 'R C', 'Initials': 'RC', 'LastName': 'Stein', 'Affiliation': 'National Institute for Health Research, University College London Hospitals Biomedical Research Centre, London, UK.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Paramasivan', 'Affiliation': 'Population Health Sciences, University of Bristol, Bristol, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Marshall', 'Affiliation': 'Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Bartlett', 'Affiliation': 'Ontario Institute for Cancer Research, Toronto, Ontario, Canada.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Cameron', 'Affiliation': 'The University of Edinburgh, Cancer Research UK Edinburgh Centre, Western General Hospital, EH4 University Cancer Centre, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Campbell', 'Affiliation': 'Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Dunn', 'Affiliation': 'Warwick Medical School, University of Warwick, Coventry, UK.'}, {'ForeName': 'H', 'Initials': 'H', 'LastName': 'Earl', 'Affiliation': ""Oncology Centre, Addenbrooke's Hospital, Cambridge, UK.""}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'Hall', 'Affiliation': 'The University of Edinburgh, Cancer Research UK Edinburgh Centre, Western General Hospital, EH4 University Cancer Centre, University of Edinburgh, Edinburgh, UK.'}, {'ForeName': 'V', 'Initials': 'V', 'LastName': 'Harmer', 'Affiliation': 'Imperial College Healthcare NHS Trust, Charing Cross Hospital, London, UK.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Hughes-Davies', 'Affiliation': ""Oncology Centre, Addenbrooke's Hospital, Cambridge, UK.""}, {'ForeName': 'I', 'Initials': 'I', 'LastName': 'Macpherson', 'Affiliation': 'Beatson West of Scotland Cancer Centre, Glasgow, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Makris', 'Affiliation': 'Mount Vernon Cancer Centre, Mount Vernon Hospital, Northwood, UK.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Morgan', 'Affiliation': ""Independent Cancer Patients' Voice, London, UK.""}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Pinder', 'Affiliation': ""King's College London, Comprehensive Cancer Centre at Guy's Hospital, London, UK.""}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Poole', 'Affiliation': 'Arden Cancer Centre, University Hospitals Coventry and Warwickshire, Coventry, UK.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Rea', 'Affiliation': 'School of Cancer Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Rooshenas', 'Affiliation': 'Population Health Sciences, University of Bristol, Bristol, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Clinical oncology (Royal College of Radiologists (Great Britain)),['10.1016/j.clon.2020.01.029'] 3238,31800355,"Use of Topical 0.01% Atropine for Controlling Near Work-Induced Transient Myopia: A Randomized, Double-Masked, Placebo-Controlled Study.","Purpose: To investigate the efficacy and safety of topical low-concentration (0.01%) atropine for controlling near work-induced transient myopia (NITM) in a young Chinese population. Methods: This was a randomized, double-blinded, placebo-controlled study. The participants were randomly divided into the 0.5% hydroxypropyl-methylcellulose-treated group (control group) or 0.01% atropine-treated group (study group). Participants' pulse rate, respiration rate, intraocular pressure, pupil diameter, and magnitude of initial NITM were evaluated at baseline and on day 7 and 14 during treatment. In addition, ocular discomfort and adverse effects were recorded. Results: Of the initial 176 participants, 145 (82.4%) completed the 14-day treatment and all evaluations. At baseline, no difference in the magnitude of initial NITM was observed between the control and study groups ( P  = 0.826). However, the magnitude of initial NITM of the study group was significantly lower at both day 7 (-0.11 ± 0.227 D) and day 14 (0.076 ± 0.183 D) after treatment initiation, compared with the magnitude of initial NITM in the control group ( P  < 0.001). No serious complications were observed. However, significantly larger pupil diameters were noted on day 7 and 14 in the study group than in the control group ( P  < 0.001). Conclusions: We speculate that daily topical 0.01% atropine application effectively reduced the magnitude of initial NITM, without any serious complications. The minimal pupil dilation induced by the treatment was acceptable. Low-concentration atropine may be useful in clinical settings as treatment for young patients with NITM.",2020,No serious complications were observed.,"['Induced Transient Myopia', 'young patients with NITM', 'young Chinese population']","['Placebo', 'Low-concentration atropine', 'topical low-concentration (0.01%) atropine', 'Topical 0.01% Atropine', 'hydroxypropyl-methylcellulose-treated group (control group) or 0.01% atropine-treated group', 'placebo', 'atropine']","['pulse rate, respiration rate, intraocular pressure, pupil diameter, and magnitude of initial NITM', 'efficacy and safety', 'ocular discomfort and adverse effects', 'minimal pupil dilation', 'magnitude of initial NITM', 'serious complications', 'larger pupil diameters']","[{'cui': 'C0205374', 'cui_str': 'Transitory (qualifier value)'}, {'cui': 'C0027092', 'cui_str': 'Nearsightedness'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0152035', 'cui_str': 'Chinese'}, {'cui': 'C0032659', 'cui_str': 'Population'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0004259', 'cui_str': 'Atropine'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C4517393', 'cui_str': '0.01'}, {'cui': 'C0063242', 'cui_str': 'hypromellose'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0232117', 'cui_str': 'Pulse Rate'}, {'cui': 'C0231832', 'cui_str': 'Respiration Rate'}, {'cui': 'C0021888', 'cui_str': 'Ocular Tension'}, {'cui': 'C0034121', 'cui_str': 'Pupil'}, {'cui': 'C1301886', 'cui_str': 'Diameter (qualifier value)'}, {'cui': 'C1704240', 'cui_str': 'Magnitudes (qualifier value)'}, {'cui': 'C0205265', 'cui_str': 'Initial (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0948595', 'cui_str': 'Ocular discomfort'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0547040', 'cui_str': 'Minimal (qualifier value)'}, {'cui': 'C0026961', 'cui_str': 'Mydriasis'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C2981139', 'cui_str': 'Large pupil (finding)'}]",176.0,0.251421,No serious complications were observed.,"[{'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Guo', 'Affiliation': 'Ophthalmology and Optometry Center, First Hospital of China Medical University, Shenyang, China.'}, {'ForeName': 'Liying', 'Initials': 'L', 'LastName': 'Fan', 'Affiliation': ""Department of Ophthalmology, The 4th People's Hospital of Shenyang, Shenyang, China.""}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Tao', 'Affiliation': ""Department of Ophthalmology, The 4 People's Hospital of Shenyang, Shenyang, China.""}, {'ForeName': 'Rui', 'Initials': 'R', 'LastName': 'Hua', 'Affiliation': 'Department of Ophthalmology, First Hospital of China Medical University, Shenyang, China.'}, {'ForeName': 'Qiang', 'Initials': 'Q', 'LastName': 'Yang', 'Affiliation': 'Department of Ophthalmology, Shenyang Xingqi Eye Hospital, Shenyang, China.'}, {'ForeName': 'Hong', 'Initials': 'H', 'LastName': 'Gu', 'Affiliation': 'Department of Ophthalmology, Shenyang Xingqi Eye Hospital, Shenyang, China.'}, {'ForeName': 'Shiyuan', 'Initials': 'S', 'LastName': 'Yu', 'Affiliation': 'Department of Ophthalmology, Shenyang Xingqi Eye Hospital, Shenyang, China.'}, {'ForeName': 'Linwei', 'Initials': 'L', 'LastName': 'Li', 'Affiliation': 'Department of Ophthalmology, Shenyang Xingqi Eye Hospital, Shenyang, China.'}, {'ForeName': 'Xin', 'Initials': 'X', 'LastName': 'Zhao', 'Affiliation': 'Department of Ophthalmology, Shenyang Xingqi Eye Hospital, Shenyang, China.'}]",Journal of ocular pharmacology and therapeutics : the official journal of the Association for Ocular Pharmacology and Therapeutics,['10.1089/jop.2019.0062'] 3239,32029547,Noninvasive vagus nerve stimulation and the trigeminal autonomic reflex: An fMRI study.,"OBJECTIVE The trigeminal autonomic reflex is a physiologic reflex that plays a crucial role in primary headache and particularly in trigeminal autonomic cephalalgias, such as cluster headache. Previous studies have shown that this reflex can be modulated by the vagus nerve, leading to an inhibition of the parasympathetic output of the reflex in healthy participants. The aim of the present study was to characterize neural correlates of the modulatory effect of noninvasive vagus nerve stimulation (nVNS) on the trigeminal autonomic reflex. METHODS Twenty-one healthy participants were included in a 2-day, randomized, single-blind, within-subject design. The reflex was activated inside the MRI scanner using kinetic oscillation stimulation placed in the left nostril, resulting in an increase in lacrimation. After the first fMRI session, the participants received either sham vagus nerve stimulation or nVNS outside the scanner and underwent a subsequent fMRI session. RESULTS nVNS prompted an increase in activation of the left pontine nucleus and a decreased activation of the right parahippocampal gyrus. Psychophysiologic interaction analyses revealed an increased functional connectivity between the left pontine nucleus and the right hypothalamus and a decreased functional connectivity between the right parahippocampal gyrus and the bilateral spinal trigeminal nuclei (sTN). CONCLUSIONS These findings indicate a complex network involved in the modulatory effect of nVNS including the hypothalamus, the sTN, the pontine nucleus, and the parahippocampal gyrus.",2020,"RESULTS nVNS prompted an increase in activation of the left pontine nucleus and a decreased activation of the right parahippocampal gyrus.","['Twenty-one healthy participants', 'healthy participants']","['sham vagus nerve stimulation or nVNS outside the scanner and underwent a subsequent fMRI session', 'noninvasive vagus nerve stimulation (nVNS', 'Noninvasive vagus nerve stimulation']","['activation of the left pontine nucleus', 'functional connectivity']","[{'cui': 'C3715213', 'cui_str': '21 (qualifier value)'}, {'cui': 'C1708335', 'cui_str': 'Healthy Participants'}]","[{'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C2350432', 'cui_str': 'Vagal Nerve Stimulation'}, {'cui': 'C0205101', 'cui_str': 'External (qualifier value)'}, {'cui': 'C0183115', 'cui_str': 'Scanner'}, {'cui': 'C0376335', 'cui_str': 'fMRI'}]","[{'cui': 'C0228448', 'cui_str': 'Structure of nucleus of pons'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}]",21.0,0.0292132,"RESULTS nVNS prompted an increase in activation of the left pontine nucleus and a decreased activation of the right parahippocampal gyrus.","[{'ForeName': 'Maike', 'Initials': 'M', 'LastName': 'Möller', 'Affiliation': 'From the Department of Systems Neuroscience, University Medical Center Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Mehnert', 'Affiliation': 'From the Department of Systems Neuroscience, University Medical Center Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Celina F', 'Initials': 'CF', 'LastName': 'Schroeder', 'Affiliation': 'From the Department of Systems Neuroscience, University Medical Center Eppendorf, Hamburg, Germany.'}, {'ForeName': 'Arne', 'Initials': 'A', 'LastName': 'May', 'Affiliation': 'From the Department of Systems Neuroscience, University Medical Center Eppendorf, Hamburg, Germany. a.may@uke.de.'}]",Neurology,['10.1212/WNL.0000000000008865'] 3240,31262847,Using mHealth for the management of hypertension in UK primary care: an embedded qualitative study of the TASMINH4 randomised controlled trial.,"BACKGROUND Self-monitoring of blood pressure is common but how telemonitoring with a mobile healthcare (mHealth) solution in the management of hypertension can be implemented by patients and healthcare professionals (HCPs) is currently unclear. AIM Evaluation of facilitators and barriers to self- and telemonitoring interventions for hypertension within the Telemonitoring and Self-monitoring in Hypertension (TASMINH4) trial. DESIGN AND SETTING An embedded process evaluation of the TASMINH4 randomised controlled trial (RCT), in the West Midlands, in UK primary care, conducted between March 2015 and September 2016. METHOD A total of 40 participants comprising 23 patients were randomised to one of two arms: mHealth (self-monitoring by free text/short message service [SMS]) and self-monitoring without mHealth (self-monitoring using paper diaries). There were also15 healthcare professionals (HCPs) and two patient caregivers. RESULTS Four key implementation priority areas concerned: acceptability of self- and telemonitoring to patients and HCPs; managing data; communication; and integrating self-monitoring into hypertension management (structured care). Structured home monitoring engaged and empowered patients to self-monitor regardless of the use of mHealth, whereas telemonitoring potentially facilitated more rapid communication between HCPs and patients. Paper-based recording integrated better into current workflows but required additional staff input. CONCLUSION Although telemonitoring by mHealth facilitates easier communication and convenience, the realities of current UK general practice meant that a paper-based approach to self-monitoring could be integrated into existing workflows with greater ease. Self-monitoring should be offered to all patients with hypertension. Telemonitoring appears to give additional benefits to practices over and above self-monitoring but both need to be offered to ensure generalisability.",2019,"Structured home monitoring engaged and empowered patients to self-monitor regardless of the use of mHealth, whereas telemonitoring potentially facilitated more rapid communication between HCPs and patients.","['West Midlands, in UK primary care, conducted between March 2015 and September 2016', '40 participants comprising 23 patients', 'patients with hypertension', 'hypertension in UK primary care']","['facilitators and barriers to self- and telemonitoring interventions', 'mHealth (self-monitoring by free text/short message service [SMS]) and self-monitoring without mHealth (self-monitoring using paper diaries']",[],"[{'cui': 'C0454882', 'cui_str': 'West Midlands (geographic location)'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2363982', 'cui_str': 'Hypertension (SMQ)'}]","[{'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C2718080', 'cui_str': 'mHealth'}, {'cui': 'C0588436', 'cui_str': 'Self-monitoring (regime/therapy)'}, {'cui': 'C3541382', 'cui_str': 'Text'}, {'cui': 'C3178909'}, {'cui': 'C0181904', 'cui_str': 'Monitor, device (physical object)'}, {'cui': 'C0030351', 'cui_str': 'Paper'}, {'cui': 'C0376660', 'cui_str': 'Diary'}]",[],23.0,0.0342192,"Structured home monitoring engaged and empowered patients to self-monitor regardless of the use of mHealth, whereas telemonitoring potentially facilitated more rapid communication between HCPs and patients.","[{'ForeName': 'Sabrina', 'Initials': 'S', 'LastName': 'Grant', 'Affiliation': 'Musculoskeletal Research Unit, Translational Health Sciences, Bristol Medical School, University of Bristol, Bristol.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Hodgkinson', 'Affiliation': 'Institute of Applied Health Research, Murray Learning Centre, University of Birmingham, Birmingham.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Schwartz', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Bradburn', 'Affiliation': 'Institute of Applied Health Research, Murray Learning Centre, University of Birmingham, Birmingham.'}, {'ForeName': 'Marloes', 'Initials': 'M', 'LastName': 'Franssen', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford.'}, {'ForeName': 'Fd Richard', 'Initials': 'FR', 'LastName': 'Hobbs', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford.'}, {'ForeName': 'Sue', 'Initials': 'S', 'LastName': 'Jowett', 'Affiliation': 'Institute of Applied Health Research, Murray Learning Centre, University of Birmingham, Birmingham.'}, {'ForeName': 'Richard J', 'Initials': 'RJ', 'LastName': 'McManus', 'Affiliation': 'Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford.'}, {'ForeName': 'Sheila', 'Initials': 'S', 'LastName': 'Greenfield', 'Affiliation': 'Institute of Applied Health Research, Murray Learning Centre, University of Birmingham, Birmingham.'}]",The British journal of general practice : the journal of the Royal College of General Practitioners,['10.3399/bjgp19X704585'] 3241,31755809,Comparison of Efficacy of Intravitreal Ranibizumab and Aflibercept in Eyes with Myopic Choroidal Neovascularization: 24-Month Follow-Up.,"Purpose: To compare the 24-month efficacy of intravitreal ranibizumab and aflibercept in treatment-naive patients with myopic choroidal neovascularization (CNV). Methods: Ninety-six naive patients (97 eyes) with myopic CNV were included in this single-center study. Patients received intravitreal ranibizumab (IVR) or aflibercept (IVA) following a pro re nata regimen (PRN). Results: Fifty patients (50 eyes) received 0.5 mg IVR, 46 patients (47 eyes) received 2.0 mg of IVA. There was no significant between-group difference in mean decimal best-corrected visual acuity (BCVA) ( P  = 0.6) or mean central retinal thickness (CRT) ( P  = 0.9) at 24 months. The mean ± standard deviation (SD) BCVA at baseline in the IVR group was 0.21 ± 0.14 and 0.20 ± 0.14 in the IVA group. At month 24, BCVA was 0.43 ± 0.24 ( P  < 0.001) in the IVR group and 0.41 ± 0.2 ( P  < 0.001) in the IVA group. Baseline mean ± SD CRT was 318 ± 84 microns in the IVR group and 303 ± 65 microns in the IVA group. At month 24, CRT was 226 ± 31 microns in the IVR group ( P  < 0.001) and 224 ± 35 microns in the IVA group ( P  < 0.001). There were no significant differences in the mean number of injections between the IVR group and the IVA group (2.9 ± 1.2 vs. 2.8 ± 1.1), ( P  = 0.7). Conclusions: Our study demonstrates that ranibizumab and aflibercept in a PRN regimen lead to a significant increase of BCVA and decrease in central foveal thickness in treatment-naive patients with myopic CNV after 24 months.",2020,"At month 24, CRT was 226 ± 31 microns in the IVR group ( P  < 0.001) and 224 ± 35 microns in the IVA group ( P  < 0.001).","['Methods: Ninety-six naive patients (97 eyes) with myopic CNV were included in this single-center study', 'treatment-naive patients with myopic choroidal neovascularization (CNV', 'Eyes with Myopic Choroidal Neovascularization']","['intravitreal ranibizumab (IVR) or aflibercept (IVA', '2.0\u2009mg of IVA', 'Intravitreal Ranibizumab and Aflibercept', 'ranibizumab and aflibercept', 'intravitreal ranibizumab and aflibercept']","['mean central retinal thickness (CRT', 'central foveal thickness', 'mean\u2009±\u2009standard deviation (SD) BCVA', 'mean number of injections', 'mean decimal best-corrected visual acuity (BCVA', 'BCVA']","[{'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C4319625', 'cui_str': '96'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C3665926', 'cui_str': 'Myopic choroidal neovascularization'}]","[{'cui': 'C1566537', 'cui_str': 'ranibizumab'}, {'cui': 'C1134659', 'cui_str': 'aflibercept'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0035331', 'cui_str': 'Retinal'}, {'cui': 'C0871420', 'cui_str': 'Standard deviation'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C1690532', 'cui_str': 'Best corrected visual acuity'}]",96.0,0.077529,"At month 24, CRT was 226 ± 31 microns in the IVR group ( P  < 0.001) and 224 ± 35 microns in the IVA group ( P  < 0.001).","[{'ForeName': 'Andrii', 'Initials': 'A', 'LastName': 'Korol', 'Affiliation': 'The Filatov Institute of Eye Diseases and Tissue Therapy of the National Academy of Medical Sciences of Ukraine, Odesa, Ukraine.'}, {'ForeName': 'Taras', 'Initials': 'T', 'LastName': 'Kustryn', 'Affiliation': 'The Filatov Institute of Eye Diseases and Tissue Therapy of the National Academy of Medical Sciences of Ukraine, Odesa, Ukraine.'}, {'ForeName': 'Oleg', 'Initials': 'O', 'LastName': 'Zadorozhnyy', 'Affiliation': 'The Filatov Institute of Eye Diseases and Tissue Therapy of the National Academy of Medical Sciences of Ukraine, Odesa, Ukraine.'}, {'ForeName': 'Natalya', 'Initials': 'N', 'LastName': 'Pasyechnikova', 'Affiliation': 'The Filatov Institute of Eye Diseases and Tissue Therapy of the National Academy of Medical Sciences of Ukraine, Odesa, Ukraine.'}, {'ForeName': 'Igor', 'Initials': 'I', 'LastName': 'Kozak', 'Affiliation': 'Moorfields Eye Hospital Center, Al Marina, Abu Dhabi, United Arab Emirates.'}]",Journal of ocular pharmacology and therapeutics : the official journal of the Association for Ocular Pharmacology and Therapeutics,['10.1089/jop.2019.0080'] 3242,31760314,"Erythrocyte-encapsulated asparaginase (eryaspase) combined with chemotherapy in second-line treatment of advanced pancreatic cancer: An open-label, randomized Phase IIb trial.","PURPOSE This Phase IIb (NCT02195180) open-label study evaluated erythrocyte-encapsulated asparaginase (eryaspase) in combination with chemotherapy in second-line advanced pancreatic adenocarcinoma. METHODS Eligible patients were randomized 2:1 to either eryaspase in combination with gemcitabine or mFOLFOX6 (eryaspase arm), or to gemcitabine or mFOLFOX6 alone (control arm). Co-primary endpoints were overall survival (OS) and progression-free survival (PFS) in patients with low asparagine synthetase (ASNS) expression. Secondary endpoints included OS and PFS in the entire population. RESULTS 141 patients were randomized (eryaspase arm, n = 95; control arm, n = 46). Median OS and PFS in patients with low ASNS expression were 6.2 months (95% CI, 5.1-8.8) in the eryaspase arm versus 4.9 months (3.1-7.1) in the control arm (HR, 0.63; 95% CI, 0.39-1.01; P = 0.056) and 2.0 months (95% CI, 1.8-3.4) in the eryaspase arm versus 1.8 months (1.4-3.8) in the control arm (HR, 0.67; 95% CI, 0.40-1.12; P = 0.127), respectively. In the entire population, median OS and PFS for the eryaspase arm versus control were 6.0 months versus 4.4 months (HR, 0.60; P = 0.008) and 2.0 months versus 1.6 months (HR, 0.56; 95% CI, 0.37-0.84; P = 0.005), respectively. The combination of eryaspase and chemotherapy was well tolerated. The most frequent Grade 3/4 adverse events in the eryaspase arm (n = 93) were gamma-glutamyltransferase increase (16 [17.2%]), neutropenia (12 [12.9%]), and physical health deterioration (12 [12.9%]). CONCLUSION Eryaspase in combination with chemotherapy is associated with improvements in OS and PFS, irrespective of ASNS expression in second-line advanced pancreatic adenocarcinoma. A Phase III trial is underway.",2020,"In the entire population, median OS and PFS for the eryaspase arm versus control were 6.0 months versus 4.4 months (HR, 0.60; P = 0.008) and 2.0 months versus 1.6 months (HR, 0.56; 95% CI, 0.37-0.84; P = 0.005), respectively.","['141 patients', 'Eligible patients', 'patients with low asparagine synthetase (ASNS) expression', 'advanced pancreatic cancer', 'second-line advanced pancreatic adenocarcinoma']","['eryaspase in combination with gemcitabine or mFOLFOX6 (eryaspase arm), or to gemcitabine or mFOLFOX6 alone (control arm', 'erythrocyte-encapsulated asparaginase (eryaspase) in combination with chemotherapy', 'Erythrocyte-encapsulated asparaginase (eryaspase) combined with chemotherapy']","['tolerated', 'overall survival (OS) and progression-free survival (PFS', 'gamma-glutamyltransferase increase', 'median OS and PFS', 'Median OS and PFS', 'OS and PFS in the entire population', 'physical health deterioration', 'neutropenia']","[{'cui': 'C4517572', 'cui_str': 'One hundred and forty-one'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0003997', 'cui_str': 'Asparagine Synthase'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0346647', 'cui_str': 'Cancer of Pancreas'}, {'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0281361', 'cui_str': 'Adenocarcinoma of pancreas'}]","[{'cui': 'C0045093', 'cui_str': 'gemcitabine'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0014792', 'cui_str': 'Blood Corpuscles, Red'}, {'cui': 'C0205223', 'cui_str': 'Encapsulated (qualifier value)'}, {'cui': 'C0003993', 'cui_str': 'ASPARAGINASE'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0336789', 'cui_str': 'Combine'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0151662', 'cui_str': 'Gamma-glutamyl transferase raised (finding)'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0439751', 'cui_str': 'Entire (qualifier value)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0027947', 'cui_str': 'Neutropenia'}]",141.0,0.0757815,"In the entire population, median OS and PFS for the eryaspase arm versus control were 6.0 months versus 4.4 months (HR, 0.60; P = 0.008) and 2.0 months versus 1.6 months (HR, 0.56; 95% CI, 0.37-0.84; P = 0.005), respectively.","[{'ForeName': 'Pascal', 'Initials': 'P', 'LastName': 'Hammel', 'Affiliation': 'Digestive and Medical Oncology Unit, Hôpital Beaujon, Assistance Publique - Hôpitaux de Paris, University Denis Diderot Paris VII, 92110 Clichy, France. Electronic address: pascal.hammel@aphp.fr.'}, {'ForeName': 'Portales', 'Initials': 'P', 'LastName': 'Fabienne', 'Affiliation': 'Parc Euromedecine, 208 Rue Des Apothicaires, 34070 Montpellier, France.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Mineur', 'Affiliation': 'Institut Sainte Catherine, Gastrointestinal and Liver Cancer Unit, Chemin de Baigne Pieds, 84000 Avignon, France.'}, {'ForeName': 'Jean-Philippe', 'Initials': 'JP', 'LastName': 'Metges', 'Affiliation': 'CHRU de Brest - Hôpital Morvan, 2 Avenue Foch, 29609 Brest, France.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Andre', 'Affiliation': 'Hôpital Saint-Antoine, 184 Rue du Faubourg Saint-Antoine, 75012 Paris, and Sorbonne Universités, France.'}, {'ForeName': 'Christelle', 'Initials': 'C', 'LastName': 'De La Fouchardiere', 'Affiliation': 'Medical Oncology Department, Centre Leon Berard, Lyon, France.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Louvet', 'Affiliation': 'Department of Medical Oncology, Institut Mutualiste Montsouris, 42 Boulevard Jourdan, 75014 Paris, France.'}, {'ForeName': 'Farid', 'Initials': 'F', 'LastName': 'El Hajbi', 'Affiliation': 'Centre Oscar Lambret, 3 Rue Frédéric Combemale, 59000 Lille, France.'}, {'ForeName': 'Roger', 'Initials': 'R', 'LastName': 'Faroux', 'Affiliation': 'Les Oudairies, Hospital La Roche-Sur-Yon, Boulevard Stephane Moreau, 85000 La Roche Sur Yon, France.'}, {'ForeName': 'Rosine', 'Initials': 'R', 'LastName': 'Guimbaud', 'Affiliation': 'Institut Universitaire du Cancer, Avenue Hubert Curien, 31100 Toulouse, France.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Tougeron', 'Affiliation': 'Gastroenterology Department and Medical Oncology Department, Poitiers University Hospital, Faculty of Medicine of Poitiers, 86000 Poitiers, France.'}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Bouche', 'Affiliation': 'Service Oncologie Digestive, CHU Reims, Avenue Général Koenig, 51092 Reims Cede, France.'}, {'ForeName': 'Thierry', 'Initials': 'T', 'LastName': 'Lecomte', 'Affiliation': 'Department of Hepatogastroenterology and Digestive Oncology, CHU de Tours, 37044 Tours Cedex, France.'}, {'ForeName': 'Christine', 'Initials': 'C', 'LastName': 'Rebischung', 'Affiliation': 'Groupe Hospitalier Mutualiste de Grenoble, 8 Rue Docteur Calmette, 38100 Grenoble, France.'}, {'ForeName': 'Christophe', 'Initials': 'C', 'LastName': 'Tournigand', 'Affiliation': ""Service d'Oncologie médicale, Hôpital Henri Mondor, AP-HP, Université Paris-Est, 94010 Créteil, France.""}, {'ForeName': 'Jerome', 'Initials': 'J', 'LastName': 'Cros', 'Affiliation': 'Beaujon University Hospital, Department of Pathology-INSERM U1149, 100 Bvd Gal Lerclerc, 92110 Clichy, France.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Kay', 'Affiliation': 'RK Statistics Ltd, St Giles View, Main Street, Great Longstone, Bakewell, DE45 1TZ, UK.'}, {'ForeName': 'Adam', 'Initials': 'A', 'LastName': 'Hamm', 'Affiliation': 'Cytel Inc., 675 Massachusetts Ave Cambridge, MA 02139, USA.'}, {'ForeName': 'Anu', 'Initials': 'A', 'LastName': 'Gupta', 'Affiliation': 'ERYTECH, One Main Street, Suite 1150, Cambridge, MA 02142, USA.'}, {'ForeName': 'Jean-Baptiste', 'Initials': 'JB', 'LastName': 'Bachet', 'Affiliation': 'Sorbonne Universités, UPMC Université, Gastroenterology and Digestive Oncology Department, Pitié Salpêtrière Hospital, 75013 Paris, France.'}, {'ForeName': 'Iman', 'Initials': 'I', 'LastName': 'El Hariry', 'Affiliation': 'ERYTECH, One Main Street, Suite 1150, Cambridge, MA 02142, USA.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2019.10.020'] 3243,31179916,"Study protocol for a cluster randomized controlled trial to test ""¡Míranos! Look at Us, We Are Healthy!"" - an early childhood obesity prevention program.","BACKGROUND One in three Head Start children is either overweight or obese. We will test the efficacy of an early childhood obesity prevention program, ""¡Míranos! Look at Us, We Are Healthy!"" (¡Míranos!), which promotes healthy growth and targets multiple energy balance-related behaviors in predominantly Latino children in Head Start. The ¡Míranos! intervention includes center-based (policy changes, staff development, gross motor program, and nutrition education) and home-based (parent engagement/education and home visits) interventions to address key enablers and barriers in obesity prevention in childcare. In partnership with Head Start, we have demonstrated the feasibility and acceptability of the proposed interventions to influence energy balance-related behaviors favorably in Head Start children. METHODS Using a three-arm cluster randomized controlled design, 12 Head Start centers will be randomly assigned in equal number to one of three conditions: 1) a combined center- and home-based intervention, 2) center-based intervention only, or 3) comparison. The interventions will be delivered by trained Head Start staff during the academic year. A total of 444 3-year-old children (52% females; n = 37 per center at baseline) in two cohorts will be enrolled in the study and followed prospectively 1 year post-intervention. Data collection will be conducted at baseline, immediately post-intervention, and at the one-year follow-up and will include height, weight, physical activity (PA) and sedentary behaviors, sleep duration and screen time, gross motor development, dietary intake and food and activity preferences. Information on family background, parental weight, PA- and nutrition-related practices and behaviors, PA and nutrition policy and environment at center and home, intervention program costs, and treatment fidelity will also be collected. DISCUSSION With endorsement and collaboration of two local Head Start administrators, ¡Míranos!, as a culturally tailored obesity prevention program, is poised to provide evidence of efficacy and cost-effectiveness of a policy and environmental approach to prevent early onset of obesity in low-income Latino preschool children. ¡Míranos! can be disseminated to various organized childcare settings, as it is built on the Head Start program and its infrastructure, which set a gold standard for early childhood education, as well as current PA and nutrition recommendations for preschool children. TRIAL REGISTRATION ClinicalTrials.Gov ( NCT03590834 ) July 18, 2018.",2019,", as a culturally tailored obesity prevention program, is poised to provide evidence of efficacy and cost-effectiveness of a policy and environmental approach to prevent early onset of obesity in low-income Latino preschool children. ¡","['low-income Latino preschool children. ¡', 'three Head Start children is either overweight or obese', 'A total of 444 3-year-old children (52% females; n\u2009=\u200937 per center at baseline) in two cohorts will be enrolled in the study and followed prospectively 1\u2009year post-intervention', 'preschool children', '12 Head Start centers', 'Healthy', 'predominantly Latino children in Head Start', 'Head Start children']","['intervention includes center-based (policy changes, staff development, gross motor program, and nutrition education) and home-based (parent engagement/education and home visits) interventions to address key enablers and barriers in obesity prevention in childcare', 'early childhood obesity prevention program, ""¡', '¡', 'combined center- and home-based intervention, 2) center-based intervention only, or 3) comparison']","['height, weight, physical activity (PA) and sedentary behaviors, sleep duration and screen time, gross motor development, dietary intake and food and activity preferences']","[{'cui': 'C0302604', 'cui_str': 'Low income'}, {'cui': 'C0086528', 'cui_str': 'Latinos'}, {'cui': 'C0008100', 'cui_str': 'Child, Preschool'}, {'cui': 'C0018670', 'cui_str': 'Head'}, {'cui': 'C1272689', 'cui_str': 'Started'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}]","[{'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0242456', 'cui_str': 'Policy'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0038123', 'cui_str': 'Staff Development'}, {'cui': 'C0439806', 'cui_str': 'Gross (qualifier value)'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0204934', 'cui_str': 'Nutritional education'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0020043', 'cui_str': 'Home Visits'}, {'cui': 'C0376649', 'cui_str': 'Address'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0599196', 'cui_str': 'Early childhood'}, {'cui': 'C0336789', 'cui_str': 'Combine'}]","[{'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1532253', 'cui_str': 'Sedentary Behavior'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C4704787', 'cui_str': 'Screen Time'}, {'cui': 'C0439806', 'cui_str': 'Gross (qualifier value)'}, {'cui': 'C0243107', 'cui_str': 'development'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}, {'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0558295', 'cui_str': 'Preferences (qualifier value)'}]",,0.0585893,", as a culturally tailored obesity prevention program, is poised to provide evidence of efficacy and cost-effectiveness of a policy and environmental approach to prevent early onset of obesity in low-income Latino preschool children. ¡","[{'ForeName': 'Zenong', 'Initials': 'Z', 'LastName': 'Yin', 'Affiliation': 'Department of Kinesiology, Health and Nutrition, The University of Texas at San Antonio, San Antonio, TX, USA. zenong.yin@utsa.edu.'}, {'ForeName': 'Sarah L', 'Initials': 'SL', 'LastName': 'Ullevig', 'Affiliation': 'Department of Kinesiology, Health and Nutrition, The University of Texas at San Antonio, San Antonio, TX, USA.'}, {'ForeName': 'Erica', 'Initials': 'E', 'LastName': 'Sosa', 'Affiliation': 'Department of Kinesiology, Health and Nutrition, The University of Texas at San Antonio, San Antonio, TX, USA.'}, {'ForeName': 'Yuanyuan', 'Initials': 'Y', 'LastName': 'Liang', 'Affiliation': 'Department of Epidemiology and Public Health, The University of Maryland, School of Medicine, Baltimore, MD, USA.'}, {'ForeName': 'Todd', 'Initials': 'T', 'LastName': 'Olmstead', 'Affiliation': 'Department of Mexican American and Latina/o Studies Austin, The University of Texas at Austin, Austin, TX, USA.'}, {'ForeName': 'Jeffrey T', 'Initials': 'JT', 'LastName': 'Howard', 'Affiliation': 'Department of Kinesiology, Health and Nutrition, The University of Texas at San Antonio, San Antonio, TX, USA.'}, {'ForeName': 'Vanessa L', 'Initials': 'VL', 'LastName': 'Errisuriz', 'Affiliation': 'Department of Mexican American and Latina/o Studies Austin, The University of Texas at Austin, Austin, TX, USA.'}, {'ForeName': 'Vanessa M', 'Initials': 'VM', 'LastName': 'Estrada', 'Affiliation': 'Department of Kinesiology, Health and Nutrition, The University of Texas at San Antonio, San Antonio, TX, USA.'}, {'ForeName': 'Cristina E', 'Initials': 'CE', 'LastName': 'Martinez', 'Affiliation': 'Department of Kinesiology, Health and Nutrition, The University of Texas at San Antonio, San Antonio, TX, USA.'}, {'ForeName': 'Meizi', 'Initials': 'M', 'LastName': 'He', 'Affiliation': 'Department of Kinesiology, Health and Nutrition, The University of Texas at San Antonio, San Antonio, TX, USA.'}, {'ForeName': 'Sharon', 'Initials': 'S', 'LastName': 'Small', 'Affiliation': 'Parent/Child Incorporated of San Antonio and Bexar County, San Antonio, TX, USA.'}, {'ForeName': 'Cindy', 'Initials': 'C', 'LastName': 'Schoenmakers', 'Affiliation': 'Family Service Association of San Antonio, Inc., San Antonio, TX, USA.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Parra-Medina', 'Affiliation': 'Department of Mexican American and Latina/o Studies Austin, The University of Texas at Austin, Austin, TX, USA. parramedina@austin.austin.utexas.edu.'}]",BMC pediatrics,['10.1186/s12887-019-1541-4'] 3244,31548894,Analysis of serious adverse events in a paediatric fast breathing pneumonia clinical trial in Malawi.,"Introduction Pneumonia is the leading infectious killer of children. We conducted a double-blind, randomised controlled non-inferiority trial comparing placebo to amoxicillin treatment for fast breathing pneumonia in HIV-negative children aged 2-59 months in Malawi. Occurrence of serious adverse events (SAEs) during the trial were examined to assess disease progression, co-morbidities, recurrence of pneumonia and side effects of amoxicillin. Methods Enrolled children with fast breathing for age and a history of cough <14 days or difficult breathing were randomised to either placebo or amoxicillin for 3 days, and followed for 14 days to track clinical characteristics and outcomes. Medical history, physical exam, laboratory results and any chest radiographs collected at screening, enrolment and during hospitalisation were evaluated. All SAE reports were reviewed for additional information regarding hospitalisation, course of treatment and outcome. Results In total, 102/1126 (9.0%) enrolled children with fast breathing pneumonia were reported to have a SAE. Seventy-five per cent (n=77) of SAEs were pneumonia-related (p<0.01). Children<2 years of age represented the greatest proportion (61/77, 79.2%) of those with a pneumonia-related SAE. In the amoxicillin group, there were 46 SAEs and 5 (10.9%) cases were identified as possibly related to study drug (4 gastroenteritis and 1 fever). There were no life-threatening pneumonia SAEs or deaths in either group, and by the time of exit from the study, all children recovered without sequelae. Discussion In this fast breathing pneumonia clinical trial, SAEs occurred infrequently in both the amoxicillin and placebo groups, and amoxicillin was well tolerated. Trial registration number NCT02760420. https://clinicaltrials.gov/ct2/show/NCT02760420?term=ginsburg&rank=9.",2019,Seventy-five per cent (n=77) of SAEs were pneumonia-related (p<0.01).,"['Enrolled children with fast breathing for age and a history of cough <14 days or difficult breathing', 'In total, 102/1126 (9.0%) enrolled children with fast breathing pneumonia', 'fast breathing pneumonia in HIV-negative children aged 2-59 months in Malawi']","['placebo', 'amoxicillin', 'placebo or amoxicillin']","['disease progression, co-morbidities, recurrence of pneumonia and side effects of amoxicillin', 'tolerated', 'no life-threatening pneumonia SAEs or deaths']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0035203', 'cui_str': 'Breathing'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0010200', 'cui_str': 'Complaining of cough (finding)'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0332218', 'cui_str': 'With difficulty'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0481430', 'cui_str': 'HTLV-3 antibody negative'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0024548', 'cui_str': 'Republic of Malawi'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0002645', 'cui_str': 'Amoxicillin'}]","[{'cui': 'C0242656', 'cui_str': 'Disease Progression'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C0002645', 'cui_str': 'Amoxicillin'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0011065', 'cui_str': 'Death'}]",46.0,0.227335,Seventy-five per cent (n=77) of SAEs were pneumonia-related (p<0.01).,"[{'ForeName': 'Evangelyn', 'Initials': 'E', 'LastName': 'Nkwopara', 'Affiliation': 'International Programs, Save the Children Federation Inc, Fairfield, Connecticut, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Schmicker', 'Affiliation': 'Department of Biostatistics, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Tisungane', 'Initials': 'T', 'LastName': 'Mvalo', 'Affiliation': 'Department of Pediatrics, University of North Carolina Project, Lilongwe Medical Relief Fund Trust, Lilongwe, Malawi.'}, {'ForeName': 'Melda', 'Initials': 'M', 'LastName': 'Phiri', 'Affiliation': 'Department of Pediatrics, University of North Carolina Project, Lilongwe Medical Relief Fund Trust, Lilongwe, Malawi.'}, {'ForeName': 'Ajib', 'Initials': 'A', 'LastName': 'Phiri', 'Affiliation': 'Department of Pediatrics and Child Health, University of Malawi College of Medicine, Blantyre, Malawi.'}, {'ForeName': 'Mari', 'Initials': 'M', 'LastName': 'Couasnon', 'Affiliation': 'International Programs, Save the Children Federation Inc, Fairfield, Connecticut, USA.'}, {'ForeName': 'Eric D', 'Initials': 'ED', 'LastName': 'McCollum', 'Affiliation': 'Eudowood Division of Pediatric Respiratory Sciences, Department of Pediatrics, Johns Hopkins School of Medicine, Baltimore, Maryland, USA.'}, {'ForeName': 'Amy Sarah', 'Initials': 'AS', 'LastName': 'Ginsburg', 'Affiliation': 'International Programs, Save the Children Federation Inc, Fairfield, Connecticut, USA.'}]",BMJ open respiratory research,['10.1136/bmjresp-2019-000415'] 3245,31474750,"Aerobic exercise training improves hepatic and muscle insulin sensitivity, but reduces splanchnic glucose uptake in obese humans with type 2 diabetes.","BACKGROUND Aerobic exercise training is known to have beneficial effects on whole-body glucose metabolism in people with type 2 diabetes (T2D). The responses of the liver to such training are less well understood. The purpose of this study was to determine the effect of aerobic exercise training on splanchnic glucose uptake (SGU) and insulin-mediated suppression of endogenous glucose production (EGP) in obese subjects with T2D. METHODS Participants included 11 obese humans with T2D, who underwent 15 ± 2 weeks of aerobic exercise training (AEX; n = 6) or remained sedentary for 15 ± 1 weeks (SED; n = 5). After an initial screening visit, each subject underwent an oral glucose load clamp and an isoglycemic/two-step (20 and 40 mU/m 2 /min) hyperinsulinemic clamp (ISO-clamp) to assess SGU and insulin-mediated suppression of EGP, respectively. After the intervention period, both tests were repeated. RESULTS In AEX, the ability of insulin to suppress EGP was improved during both the low (69 ± 9 and 80 ± 6% suppression; pre-post, respectively; p < 0.05) and high (67 ± 6 and 82 ± 4% suppression, respectively; p < 0.05) insulin infusion periods. Despite markedly improved muscle insulin sensitivity, SGU was reduced in AEX after training (22.9 ± 3.3 and 9.1 ± 6.0 g pre-post in AEX, respectively; p < 0.05). CONCLUSIONS In obese T2D subjects, exercise training improves whole-body glucose metabolism, in part, by improving insulin-mediated suppression of EGP and enhancing muscle glucose uptake, which occur despite reduced SGU during an oral glucose challenge.",2019,"Despite markedly improved muscle insulin sensitivity, SGU was reduced in AEX after training (22.9 ± 3.3 and 9.1 ± 6.0 g pre-post in AEX, respectively; p < 0.05). ","['people with type 2 diabetes (T2D', 'obese subjects with T2D.\nMETHODS\n\n\nParticipants included 11 obese humans with T2D, who underwent 15\u2009±\u20092 weeks of', 'obese humans with type 2 diabetes']","['Aerobic exercise training', 'oral glucose load clamp and an isoglycemic/two-step (20 and 40\u2009mU/m 2 /min) hyperinsulinemic clamp (ISO-clamp', 'exercise training', 'aerobic exercise training (AEX; n\u2009=\u20096) or remained sedentary for 15\u2009±\u20091 weeks (SED; n\u2009=\u20095', 'aerobic exercise training']","['hepatic and muscle insulin sensitivity', 'ability of insulin to suppress EGP', 'splanchnic glucose uptake', 'splanchnic glucose uptake (SGU) and insulin-mediated suppression of endogenous glucose production (EGP', 'muscle insulin sensitivity, SGU']","[{'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C0001701', 'cui_str': 'Exercise, Aerobic'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0521213', 'cui_str': 'Clamping'}, {'cui': 'C1261552', 'cui_str': 'Step'}, {'cui': 'C0702093', 'cui_str': '/min'}, {'cui': 'C0911936', 'cui_str': 'iso(VL)'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C0026845', 'cui_str': 'Muscle Tissue'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0085732', 'cui_str': 'Ability'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C1260953', 'cui_str': 'Suppressed (qualifier value)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}, {'cui': 'C0221103', 'cui_str': 'Binocular vision suppression (disorder)'}, {'cui': 'C0205227', 'cui_str': 'Endogenous (qualifier value)'}, {'cui': 'C0033268'}]",11.0,0.0384412,"Despite markedly improved muscle insulin sensitivity, SGU was reduced in AEX after training (22.9 ± 3.3 and 9.1 ± 6.0 g pre-post in AEX, respectively; p < 0.05). ","[{'ForeName': 'Justin M', 'Initials': 'JM', 'LastName': 'Gregory', 'Affiliation': 'Ian M. Burr Division of Pediatric Endocrinology and Diabetes, Vanderbilt University School of Medicine, 1500 21st Ave, Suite 1514, Nashville, TN, 37212, USA.'}, {'ForeName': 'James A', 'Initials': 'JA', 'LastName': 'Muldowney', 'Affiliation': 'Division of Cardiovascular Medicine, Vanderbilt University School of Medicine, 2215 Garland Avenue, Nashville, TN, 37232-6015, USA.'}, {'ForeName': 'Brian G', 'Initials': 'BG', 'LastName': 'Engelhardt', 'Affiliation': 'Division of Hematology and Oncology, Vanderbilt University School of Medicine, 2215 Garland Avenue, Nashville, TN, 37232-6015, USA.'}, {'ForeName': 'Regina', 'Initials': 'R', 'LastName': 'Tyree', 'Affiliation': 'Center for Human Nutrition, Vanderbilt University School of Medicine, 2215 Garland Avenue, Nashville, TN, 37232-6015, USA.'}, {'ForeName': 'Pam', 'Initials': 'P', 'LastName': 'Marks-Shulman', 'Affiliation': 'Section of Surgical Sciences, Vanderbilt University School of Medicine, 2215 Garland Avenue, Nashville, TN, 37232-6015, USA.'}, {'ForeName': 'Heidi J', 'Initials': 'HJ', 'LastName': 'Silver', 'Affiliation': 'Center for Human Nutrition, Vanderbilt University School of Medicine, 2215 Garland Avenue, Nashville, TN, 37232-6015, USA.'}, {'ForeName': 'E Patrick', 'Initials': 'EP', 'LastName': 'Donahue', 'Affiliation': 'Department of Molecular Physiology and Biophysics, Vanderbilt University School of Medicine, 2215 Garland Avenue, Nashville, TN, 37232-6015, USA.'}, {'ForeName': 'Dale S', 'Initials': 'DS', 'LastName': 'Edgerton', 'Affiliation': 'Department of Molecular Physiology and Biophysics, Vanderbilt University School of Medicine, 2215 Garland Avenue, Nashville, TN, 37232-6015, USA.'}, {'ForeName': 'Jason J', 'Initials': 'JJ', 'LastName': 'Winnick', 'Affiliation': 'Division of Endocrinology, Diabetes and Metabolism, Department of Internal Medicine, University of Cincinnati College of Medicine, 231 Albert Sabin Way, Cincinnati, OH, 45267-0547, USA. jason.winnick@uc.edu.'}]",Nutrition & diabetes,['10.1038/s41387-019-0090-0'] 3246,31924551,"Xpert MTB/RIF Ultra versus Xpert MTB/RIF for the diagnosis of tuberculous meningitis: a prospective, randomised, diagnostic accuracy study.","BACKGROUND Xpert MTB/RIF Ultra (Xpert Ultra) might have higher sensitivity than its predecessor, Xpert MTB/RIF (Xpert), but its role in tuberculous meningitis diagnosis is uncertain. We aimed to compare Xpert Ultra with Xpert for the diagnosis of tuberculous meningitis in HIV-uninfected and HIV-infected adults. METHODS In this prospective, randomised, diagnostic accuracy study, adults (≥16 years) with suspected tuberculous meningitis from a single centre in Vietnam were randomly assigned to cerebrospinal fluid testing by either Xpert Ultra or Xpert at baseline and, if treated for tuberculous meningitis, after 3-4 weeks of treatment. Test performance (sensitivity, specificity, and positive and negative predictive values) was calculated for Xpert Ultra and Xpert and compared against clinical and mycobacterial culture reference standards. Analyses were done for all patients and by HIV status. FINDINGS Between Oct 16, 2017, and Feb 10, 2019, 205 patients were randomly assigned to Xpert Ultra (n=103) or Xpert (n=102). The sensitivities of Xpert Ultra and Xpert for tuberculous meningitis diagnosis against a reference standard of definite, probable, and possible tuberculous meningitis were 47·2% (95% CI 34·4-60·3; 25 of 53 patients) for Xpert Ultra and 39·6% (27·6-53·1; 21 of 53) for Xpert (p=0·56); specificities were 100·0% (95% CI 92·0-100·0; 44 of 44) and 100·0% (92·6-100·0; 48 of 48), respectively. In HIV-negative patients, the sensitivity of Xpert Ultra was 38·9% (24·8-55·1; 14 of 36) versus 22·9% (12·1-39·0; eight of 35) by Xpert (p=0·23). In HIV co-infected patients, the sensitivities were 64·3% (38·8-83·7; nine of 14) for Xpert Ultra and 76·9% (49·7-91·8; ten of 13) for Xpert (p=0·77). Negative predictive values were 61·1% (49·6-71·5) for Xpert Ultra and 60·0% (49·0-70·0) for Xpert. Against a reference standard of mycobacterial culture, sensitivities were 90·9% (72·2-97·5; 20 of 22 patients) for Xpert Ultra and 81·8% (61·5-92·7; 18 of 22) for Xpert (p=0·66); specificities were 93·9% (85·4-97·6; 62 of 66) and 96·9% (89·5-91·2; 63 of 65), respectively. Six (22%) of 27 patients had a positive test by Xpert Ultra after 4 weeks of treatment versus two (9%) of 22 patients by Xpert. INTERPRETATION Xpert Ultra was not statistically superior to Xpert for the diagnosis of tuberculous meningitis in HIV-uninfected and HIV-infected adults. A negative Xpert Ultra or Xpert test does not rule out tuberculous meningitis. New diagnostic strategies are urgently required. FUNDING Wellcome Trust and the Foundation for Innovative New Diagnostics.",2020,"INTERPRETATION Xpert Ultra was not statistically superior to Xpert for the diagnosis of tuberculous meningitis in HIV-uninfected and HIV-infected adults.","['205 patients', 'HIV-uninfected and HIV-infected adults', 'adults (≥16 years) with suspected tuberculous meningitis from a single centre in Vietnam']","['cerebrospinal fluid testing by either Xpert Ultra or Xpert at baseline', 'Xpert Ultra with Xpert', 'Xpert Ultra (n=103) or Xpert', 'Xpert MTB/RIF Ultra versus Xpert MTB/RIF']","['Test performance (sensitivity, specificity, and positive and negative predictive values', 'Negative predictive values', 'sensitivity of Xpert Ultra']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0750491', 'cui_str': 'Suspected (qualifier value)'}, {'cui': 'C0041318', 'cui_str': 'Tubercular Meningitis'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0042658', 'cui_str': 'Viet Nam'}]",[{'cui': 'C0007807'}],"[{'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0037791', 'cui_str': 'Specificity'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}]",205.0,0.0910628,"INTERPRETATION Xpert Ultra was not statistically superior to Xpert for the diagnosis of tuberculous meningitis in HIV-uninfected and HIV-infected adults.","[{'ForeName': 'Joseph', 'Initials': 'J', 'LastName': 'Donovan', 'Affiliation': 'Oxford University Clinical Research Unit, Centre for Tropical Medicine, Ho Chi Minh City, Vietnam; Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, UK. Electronic address: jdonovan@oucru.org.'}, {'ForeName': 'Do Dang Anh', 'Initials': 'DDA', 'LastName': 'Thu', 'Affiliation': 'Oxford University Clinical Research Unit, Centre for Tropical Medicine, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Nguyen Hoan', 'Initials': 'NH', 'LastName': 'Phu', 'Affiliation': 'Oxford University Clinical Research Unit, Centre for Tropical Medicine, Ho Chi Minh City, Vietnam; Viet Anh Ward, Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Vu Thi Mong', 'Initials': 'VTM', 'LastName': 'Dung', 'Affiliation': 'Oxford University Clinical Research Unit, Centre for Tropical Medicine, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Tran Phu', 'Initials': 'TP', 'LastName': 'Quang', 'Affiliation': 'Oxford University Clinical Research Unit, Centre for Tropical Medicine, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Ho Dang Trung', 'Initials': 'HDT', 'LastName': 'Nghia', 'Affiliation': 'Oxford University Clinical Research Unit, Centre for Tropical Medicine, Ho Chi Minh City, Vietnam; Viet Anh Ward, Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Pham Kieu Nguyet', 'Initials': 'PKN', 'LastName': 'Oanh', 'Affiliation': 'Oxford University Clinical Research Unit, Centre for Tropical Medicine, Ho Chi Minh City, Vietnam; Viet Anh Ward, Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Tran Bao', 'Initials': 'TB', 'LastName': 'Nhu', 'Affiliation': 'Viet Anh Ward, Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Nguyen Van Vinh', 'Initials': 'NVV', 'LastName': 'Chau', 'Affiliation': 'Oxford University Clinical Research Unit, Centre for Tropical Medicine, Ho Chi Minh City, Vietnam; Viet Anh Ward, Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Vu Thi Ngoc', 'Initials': 'VTN', 'LastName': 'Ha', 'Affiliation': 'Oxford University Clinical Research Unit, Centre for Tropical Medicine, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Vu Thi Ty', 'Initials': 'VTT', 'LastName': 'Hang', 'Affiliation': 'Oxford University Clinical Research Unit, Centre for Tropical Medicine, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Dong Huu Khanh', 'Initials': 'DHK', 'LastName': 'Trinh', 'Affiliation': 'Oxford University Clinical Research Unit, Centre for Tropical Medicine, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Ronald B', 'Initials': 'RB', 'LastName': 'Geskus', 'Affiliation': 'Oxford University Clinical Research Unit, Centre for Tropical Medicine, Ho Chi Minh City, Vietnam; Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Le Van', 'Initials': 'LV', 'LastName': 'Tan', 'Affiliation': 'Oxford University Clinical Research Unit, Centre for Tropical Medicine, Ho Chi Minh City, Vietnam; Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Nguyen Thuy Thuong', 'Initials': 'NTT', 'LastName': 'Thuong', 'Affiliation': 'Oxford University Clinical Research Unit, Centre for Tropical Medicine, Ho Chi Minh City, Vietnam; Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}, {'ForeName': 'Guy E', 'Initials': 'GE', 'LastName': 'Thwaites', 'Affiliation': 'Oxford University Clinical Research Unit, Centre for Tropical Medicine, Ho Chi Minh City, Vietnam; Centre for Tropical Medicine and Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, UK.'}]",The Lancet. Infectious diseases,['10.1016/S1473-3099(19)30649-8'] 3247,31621838,Antiretroviral Therapy-induced Bone Loss is Durably Suppressed by a Single Dose of Zoledronic Acid in Treatment-naïve Persons with HIV Infection: a Phase IIB Trial.,"BACKGROUND HIV-infection and antiretroviral therapy (ART) are associated with bone loss leading to increased fracture rate among persons with HIV (PWH). We previously showed long-acting antiresorptive zoledronic acid (ZOL) prevented ART-induced bone loss through 48 weeks of therapy and here investigate whether protection persisted. METHODS We randomized 63 non-osteoporotic, treatment-naïve adult PWH initiating ART to ZOL (5mg) vs. placebo, in a double-blinded, placebo-controlled, phase IIb trial. Here we analyzed the long-term outcome data (144 weeks). Plasma bone turnover markers and bone mineral density (BMD) were quantified at weeks 0, 12, 24, 48, 96, and 144. Primary outcome was change in bone resorption marker C-terminal telopeptide of collagen (CTx). Repeated-measures analyses using mixed linear models were used to estimate and compare study endpoints. RESULTS At 96 weeks, mean CTx was 62% lower with ZOL relative to placebo (n=46; CTx=0.123 vs. 0.324 ng/mL; p<0.001); at 144 weeks a 25% difference between arms was not statistically significant. At 48 weeks, lumbar spine BMD with ZOL was 11% higher than placebo (n=60; p<0.001) and remained 9-11% higher at 96 (n=46) and 144 weeks (n=41; p<0.001). 144 weeks after ZOL infusion, BMD did not change at the lumbar spine (p=0.22), but declined at the hip (p=0.04) and femoral neck (p=0.02). CONCLUSIONS A single dose of ZOL administered at ART initiation blunts bone resorption and BMD loss at key fracture-prone anatomical sites in treatment-naïve PWH for 3 years following ART initiation. A multicenter randomized Phase-III clinical trial validating these results in a larger population is needed.",2019,"At 96 weeks, mean CTx was 62% lower with ZOL relative to placebo (n=46; CTx=0.123 vs. 0.324 ng/mL; p<0.001); at 144 weeks a 25% difference between arms was not statistically significant.",['persons with HIV (PWH'],"['antiresorptive zoledronic acid (ZOL', 'ZOL', 'placebo', 'Zoledronic Acid', 'antiretroviral therapy (ART']","['Plasma bone turnover markers and bone mineral density (BMD', 'lumbar spine BMD', 'mean CTx', 'femoral neck', 'lumbar spine', 'bone resorption and BMD loss', 'bone resorption marker C-terminal telopeptide of collagen (CTx']","[{'cui': 'C0027361', 'cui_str': 'Persons'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}]","[{'cui': 'C0257685', 'cui_str': 'zoledronic acid'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0003826', 'cui_str': 'Arts'}]","[{'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0085268', 'cui_str': 'Bone Turnover'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C3887615', 'cui_str': 'Lumbar spine structure (body structure)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0010583', 'cui_str': 'Cyclophosphamide'}, {'cui': 'C0015815', 'cui_str': 'Femoral Neck'}, {'cui': 'C0005974', 'cui_str': 'Osteoclastic Bone Loss'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0009325', 'cui_str': 'Collagen'}]",63.0,0.676076,"At 96 weeks, mean CTx was 62% lower with ZOL relative to placebo (n=46; CTx=0.123 vs. 0.324 ng/mL; p<0.001); at 144 weeks a 25% difference between arms was not statistically significant.","[{'ForeName': 'Ighovwerha', 'Initials': 'I', 'LastName': 'Ofotokun', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, Emory University School of Medicine, Atlanta, GA USA.'}, {'ForeName': 'Lauren F', 'Initials': 'LF', 'LastName': 'Collins', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, Emory University School of Medicine, Atlanta, GA USA.'}, {'ForeName': 'Kehmia', 'Initials': 'K', 'LastName': 'Titanji', 'Affiliation': 'Division of Endocrinology & Metabolism & Lipids, Department of Medicine, Emory University School of Medicine, Atlanta, GA USA.'}, {'ForeName': 'Antonina', 'Initials': 'A', 'LastName': 'Foster', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, Emory University School of Medicine, Atlanta, GA USA.'}, {'ForeName': 'Caitlin A', 'Initials': 'CA', 'LastName': 'Moran', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, Emory University School of Medicine, Atlanta, GA USA.'}, {'ForeName': 'Anandi N', 'Initials': 'AN', 'LastName': 'Sheth', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, Emory University School of Medicine, Atlanta, GA USA.'}, {'ForeName': 'Cecile D', 'Initials': 'CD', 'LastName': 'Lahiri', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, Emory University School of Medicine, Atlanta, GA USA.'}, {'ForeName': 'Jeffrey L', 'Initials': 'JL', 'LastName': 'Lennox', 'Affiliation': 'Division of Infectious Diseases, Department of Medicine, Emory University School of Medicine, Atlanta, GA USA.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Ward', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Rollins School of Public Health, Emory University, Atlanta, GA, USA.'}, {'ForeName': 'Kirk A', 'Initials': 'KA', 'LastName': 'Easley', 'Affiliation': 'Department of Biostatistics and Bioinformatics, Rollins School of Public Health, Emory University, Atlanta, GA, USA.'}, {'ForeName': 'M Neale', 'Initials': 'MN', 'LastName': 'Weitzmann', 'Affiliation': 'Division of Endocrinology & Metabolism & Lipids, Department of Medicine, Emory University School of Medicine, Atlanta, GA USA.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciz1027'] 3248,31376501,The Differential Contribution of the Components of Parent-Child Interaction Therapy Emotion Development for Treatment of Preschool Depression.,"OBJECTIVE An adaptation of Parent-Child Interaction Therapy (PCIT) with a novel Emotion Development (ED) module has shown efficacy for the treatment of early childhood depression. Children who received PCIT-ED also showed healthy alterations in neural response to reward. We investigated whether the novel ED module made a unique contribution to the treatment of depression and neural response to reward, and whether child-directed intervention (CDI) and parent-directed intervention (PDI) modules (standard elements of PCIT) were also effective. METHOD Dyads who participated in a randomized controlled trial of PCIT that compared the active PCIT-ED to a wait list (WL) condition were assessed at the completion of each module of PCIT-ED (CDI, PDI, ED) or WL time equivalent for child depression and other symptoms, parenting styles, stress, and depression. Event-related potentials during a reward task were obtained at the end of standard PCIT and after the novel ED module. RESULTS Study findings showed that the ED module as well as some elements of standard PCIT were effective in reducing child depression and other forms of psychopathology. Changes in the child's neural response to reward and parental response to child emotional expression were specific to the ED module. CONCLUSION Study findings suggest that the novel ED module has added efficacy for the treatment of early childhood depression, as well as unique efficacy in changing neural responses to reward and parenting response to child emotional expression. These findings can inform clinical uses of this treatment in a modular fashion. Future studies are needed that control for session number and order of PCIT-ED modules. CLINICAL TRIAL REGISTRATION INFORMATION A Randomized Controlled Trial of PCIT-ED for Preschool Depression; https://clinicaltrials.gov/; NCT02076425.",2020,"Changes in the child's neural response to reward and parental response to child emotional expression were specific to the ED module. ","['Dyads who participated in a randomized controlled trial of', 'Preschool Depression']","['Parent Child Interaction Therapy (PCIT) with a novel Emotion Development(ED', 'PCIT', 'child directed intervention (CDI) and parent directed intervention (PDI) modules (standard elements of PCIT', 'active PCIT-ED', 'PCIT-ED']","['Event related potentials (ERPs', 'child depression', 'PCIT-ED (CDI, PDI, ED) or WL time equivalent for child depression and other symptoms, parenting styles, stress, and depression']","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}]","[{'cui': 'C0085092', 'cui_str': 'Parenting'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0687133', 'cui_str': 'Drug Interactions'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0013987', 'cui_str': 'Emotions'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C3542953', 'cui_str': 'Module (core metadata concept)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0013879', 'cui_str': 'Elements'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}]","[{'cui': 'C0282171', 'cui_str': 'Potentials, Event-Related'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}]",,0.0574789,"Changes in the child's neural response to reward and parental response to child emotional expression were specific to the ED module. ","[{'ForeName': 'Joan L', 'Initials': 'JL', 'LastName': 'Luby', 'Affiliation': 'Washington University School of Medicine, St. Louis, Missouri. Electronic address: lubyj@wustl.edu.'}, {'ForeName': 'Kirsten', 'Initials': 'K', 'LastName': 'Gilbert', 'Affiliation': 'Washington University School of Medicine, St. Louis, Missouri.'}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Whalen', 'Affiliation': 'Washington University School of Medicine, St. Louis, Missouri.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Tillman', 'Affiliation': 'Washington University School of Medicine, St. Louis, Missouri.'}, {'ForeName': 'Deanna M', 'Initials': 'DM', 'LastName': 'Barch', 'Affiliation': 'Washington University School of Medicine, St. Louis, Missouri.'}]",Journal of the American Academy of Child and Adolescent Psychiatry,['10.1016/j.jaac.2019.07.937'] 3249,32143674,Adaptive conjunctive cognitive training (ACCT) in virtual reality for chronic stroke patients: a randomized controlled pilot trial.,"BACKGROUND Current evidence for the effectiveness of post-stroke cognitive rehabilitation is weak, possibly due to two reasons. First, patients typically express cognitive deficits in several domains. Therapies focusing on specific cognitive deficits might not address their interrelated neurological nature. Second, co-occurring psychological problems are often neglected or not diagnosed, although post-stroke depression is common and related to cognitive deficits. This pilot trial aims to test a rehabilitation program in virtual reality that trains various cognitive domains in conjunction, by adapting to the patient's disability and while investigating the influence of comorbidities. METHODS Thirty community-dwelling stroke patients at the chronic stage and suffering from cognitive impairment performed 30 min of daily training for 6 weeks. The experimental group followed, so called, adaptive conjunctive cognitive training (ACCT) using RGS, whereas the control group solved standard cognitive tasks at home for an equivalent amount of time. A comprehensive test battery covering executive function, spatial awareness, attention, and memory as well as independence, depression, and motor impairment was applied at baseline, at 6 weeks and 18-weeks follow-up. RESULTS At baseline, 75% of our sample had an impairment in more than one cognitive domain. The experimental group showed improvements in attention ([Formula: see text] (2) = 9.57, p < .01), spatial awareness ([Formula: see text] (2) = 11.23, p < .01) and generalized cognitive functioning ([Formula: see text] (2) = 15.5, p < .001). No significant change was seen in the executive function and memory domain. For the control group, no significant change over time was found. Further, they worsened in their depression level after treatment (T = 45, r = .72, p < .01) but returned to baseline at follow-up. The experimental group displayed a lower level of depression than the control group after treatment (Ws = 81.5, z = - 2.76, r = - .60, p < .01) and (Ws = 92, z = - 2.03, r = - .44, p < .05). CONCLUSIONS ACCT positively influences attention and spatial awareness, as well as depressive mood in chronic stroke patients. TRIAL REGISTRATION The trial was registered prospectively at ClinicalTrials.gov (NCT02816008) on June 21, 2016.",2020,"The experimental group displayed a lower level of depression than the control group after treatment (Ws = 81.5, z = - 2.76, r = - .60, p < .01) and (Ws = 92, z = - 2.03, r = - .44, p < .05). ","['Thirty community-dwelling stroke patients at the chronic stage and suffering from cognitive impairment performed 30\u2009min of daily training for 6 weeks', 'chronic stroke patients']","['adaptive conjunctive cognitive training (ACCT) using RGS', 'ACCT', 'Adaptive conjunctive cognitive training (ACCT']","['executive function and memory domain', 'level of depression', 'executive function, spatial awareness, attention, and memory as well as independence, depression, and motor impairment', 'generalized cognitive functioning', 'spatial awareness']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0038454', 'cui_str': 'Apoplexy'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0338656', 'cui_str': 'Cognitive Dysfunction'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C3536593', 'cui_str': 'Chronic stroke'}]","[{'cui': 'C1868940', 'cui_str': 'Cognitive training'}]","[{'cui': 'C0935584', 'cui_str': 'Executive Control'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C1319226', 'cui_str': 'Level of depression'}, {'cui': 'C0584950', 'cui_str': 'Spatial awareness (observable entity)'}, {'cui': 'C0004268', 'cui_str': 'Attention'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0684336', 'cui_str': 'Impairment (finding)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}]",,0.113624,"The experimental group displayed a lower level of depression than the control group after treatment (Ws = 81.5, z = - 2.76, r = - .60, p < .01) and (Ws = 92, z = - 2.03, r = - .44, p < .05). ","[{'ForeName': 'Martina', 'Initials': 'M', 'LastName': 'Maier', 'Affiliation': ""Laboratory of Synthetic, Perceptive, Emotive and Cognitive Systems (SPECS), Institute for Bioengineering of Catalonia (IBEC), The Barcelona Institute of Science and Technology, Av. d'Eduard Maristany 10-14, 08930, Barcelona, Spain.""}, {'ForeName': 'Belén Rubio', 'Initials': 'BR', 'LastName': 'Ballester', 'Affiliation': ""Laboratory of Synthetic, Perceptive, Emotive and Cognitive Systems (SPECS), Institute for Bioengineering of Catalonia (IBEC), The Barcelona Institute of Science and Technology, Av. d'Eduard Maristany 10-14, 08930, Barcelona, Spain.""}, {'ForeName': 'Nuria', 'Initials': 'N', 'LastName': 'Leiva Bañuelos', 'Affiliation': ""Rehabilitation Research Group, Institut Hospital del Mar d'Investigacions Mèdiques (IMIM), Physical Medicine and Rehabilitation Department Parc de Salut Mar (Hospital del Mar, Hospital de l'Esperança), Barcelona, Spain.""}, {'ForeName': 'Esther', 'Initials': 'E', 'LastName': 'Duarte Oller', 'Affiliation': ""Rehabilitation Research Group, Institut Hospital del Mar d'Investigacions Mèdiques (IMIM), Physical Medicine and Rehabilitation Department Parc de Salut Mar (Hospital del Mar, Hospital de l'Esperança), Barcelona, Spain.""}, {'ForeName': 'Paul F M J', 'Initials': 'PFMJ', 'LastName': 'Verschure', 'Affiliation': ""Laboratory of Synthetic, Perceptive, Emotive and Cognitive Systems (SPECS), Institute for Bioengineering of Catalonia (IBEC), The Barcelona Institute of Science and Technology, Av. d'Eduard Maristany 10-14, 08930, Barcelona, Spain. pverschure@ibecbarcelona.eu.""}]",Journal of neuroengineering and rehabilitation,['10.1186/s12984-020-0652-3'] 3250,32152202,Outcome-Related Signatures Identified by Whole Transcriptome Sequencing of Resectable Stage III/IV Melanoma Evaluated after Starting Hu14.18-IL2.,"PURPOSE We analyzed whole transcriptome sequencing in tumors from 23 patients with stage III or IV melanoma from a pilot trial of the anti-GD2 immunocytokine, hu14.18-IL2, to identify predictive immune and/or tumor biomarkers in patients with melanoma at high risk for recurrence. EXPERIMENTAL DESIGN Patients were randomly assigned to receive the first of three monthly courses of hu14.18-IL2 immunotherapy either before (Group A) or after (Group B) complete surgical resection of all known diseases. Tumors were evaluated by histology and whole transcriptome sequencing. RESULTS Tumor-infiltrating lymphocyte (TIL) levels directly associated with relapse-free survival (RFS) and overall survival (OS) in resected tumors from Group A, where early responses to the immunotherapy agent could be assessed. TIL levels directly associated with a previously reported immune signature, which associated with RFS and OS, particularly in Group A tumors. In Group A tumors, there were decreased cell-cycling gene RNA transcripts, but increased RNA transcripts for repair and growth genes. We found that outcome (RFS and OS) was directly associated with several immune signatures and immune-related RNA transcripts and inversely associated with several tumor growth-associated transcripts, particularly in Group A tumors. Most of these associations were not seen in Group B tumors. CONCLUSIONS We interpret these data to signify that both immunologic and tumoral cell processes, as measured by RNA-sequencing analyses detected shortly after initiation of hu14.18-IL2 therapy, are associated with long-term survival and could potentially be used as prognostic biomarkers in tumor resection specimens obtained after initiating neoadjuvant immunotherapy.",2020,"RESULTS Tumor infiltrating lymphocyte (TIL) levels directly associate with relapse-free survival (RFS) and overall survival (OS) in resected tumors from Group A, where early responses to the immunotherapy agent could be assessed.","['23 patients with stage III or IV melanoma', 'Patients', 'melanoma patients at high risk for recurrence']",['hu14.18-IL2 immunotherapy either before (Group A) or after (Group B) complete surgical resection of all known disease'],"['Tumor infiltrating lymphocyte (TIL) levels directly associate with relapse-free survival (RFS) and overall survival (OS', 'cell cycling gene RNA transcripts', 'Outcome-related signatures identified by Whole Transcriptome Sequencing of Resectable Stage III', 'RNA transcripts']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3 (qualifier value)'}, {'cui': 'C0025202', 'cui_str': 'Malignant Melanoma'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}]","[{'cui': 'C1529682', 'cui_str': 'EMD 273063'}, {'cui': 'C0021083', 'cui_str': 'Immunotherapy'}, {'cui': 'C0441835', 'cui_str': 'Group A (qualifier value)'}, {'cui': 'C0441836', 'cui_str': 'Group B (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0728940', 'cui_str': 'Surgical removal - action'}, {'cui': 'C0205309', 'cui_str': 'Known (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}]","[{'cui': 'C0079722', 'cui_str': 'Lymphocytes, Tumor-Infiltrating'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0332281', 'cui_str': 'Associated with (attribute)'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0017337', 'cui_str': 'Genes'}, {'cui': 'C0035668', 'cui_str': 'RNA'}, {'cui': 'C0205396', 'cui_str': 'Identified (qualifier value)'}, {'cui': 'C4086963', 'cui_str': 'Complete Transcriptome Sequencing'}, {'cui': 'C0441771', 'cui_str': 'Stage level 3 (qualifier value)'}]",23.0,0.0462348,"RESULTS Tumor infiltrating lymphocyte (TIL) levels directly associate with relapse-free survival (RFS) and overall survival (OS) in resected tumors from Group A, where early responses to the immunotherapy agent could be assessed.","[{'ForeName': 'Richard K', 'Initials': 'RK', 'LastName': 'Yang', 'Affiliation': 'Department of Pathology and Laboratory Medicine, University of Wisconsin-Madison, Madison, Wisconsin.'}, {'ForeName': 'Igor B', 'Initials': 'IB', 'LastName': 'Kuznetsov', 'Affiliation': 'Cancer Research Center and Department of Epidemiology and Biostatistics, University at Albany, Rensselaer, New York.'}, {'ForeName': 'Erik A', 'Initials': 'EA', 'LastName': 'Ranheim', 'Affiliation': 'Department of Pathology and Laboratory Medicine, University of Wisconsin-Madison, Madison, Wisconsin.'}, {'ForeName': 'Jun S', 'Initials': 'JS', 'LastName': 'Wei', 'Affiliation': 'Oncogenomics Section, Genetics Branch, NCI, NIH, Bethesda, Maryland.'}, {'ForeName': 'Sivasish', 'Initials': 'S', 'LastName': 'Sindiri', 'Affiliation': 'Oncogenomics Section, Genetics Branch, NCI, NIH, Bethesda, Maryland.'}, {'ForeName': 'Berkley E', 'Initials': 'BE', 'LastName': 'Gryder', 'Affiliation': 'Oncogenomics Section, Genetics Branch, NCI, NIH, Bethesda, Maryland.'}, {'ForeName': 'Vineela', 'Initials': 'V', 'LastName': 'Gangalapudi', 'Affiliation': 'Oncogenomics Section, Genetics Branch, NCI, NIH, Bethesda, Maryland.'}, {'ForeName': 'Young K', 'Initials': 'YK', 'LastName': 'Song', 'Affiliation': 'Oncogenomics Section, Genetics Branch, NCI, NIH, Bethesda, Maryland.'}, {'ForeName': 'Viharkumar', 'Initials': 'V', 'LastName': 'Patel', 'Affiliation': 'Department of Pathology and Laboratory Medicine, University of Wisconsin-Madison, Madison, Wisconsin.'}, {'ForeName': 'Jacquelyn A', 'Initials': 'JA', 'LastName': 'Hank', 'Affiliation': 'Department of Human Oncology, University of Wisconsin-Madison, Madison, Wisconsin.'}, {'ForeName': 'Cindy', 'Initials': 'C', 'LastName': 'Zuleger', 'Affiliation': 'University of Wisconsin Carbone Cancer Center (UWCCC), Madison, Wisconsin.'}, {'ForeName': 'Amy K', 'Initials': 'AK', 'LastName': 'Erbe', 'Affiliation': 'Department of Human Oncology, University of Wisconsin-Madison, Madison, Wisconsin.'}, {'ForeName': 'Zachary S', 'Initials': 'ZS', 'LastName': 'Morris', 'Affiliation': 'Department of Human Oncology, University of Wisconsin-Madison, Madison, Wisconsin.'}, {'ForeName': 'Renae', 'Initials': 'R', 'LastName': 'Quale', 'Affiliation': 'University of Wisconsin Carbone Cancer Center (UWCCC), Madison, Wisconsin.'}, {'ForeName': 'KyungMann', 'Initials': 'K', 'LastName': 'Kim', 'Affiliation': 'Department of Biostatistics and Medical Informatics, University of Wisconsin-Madison, Madison, Wisconsin.'}, {'ForeName': 'Mark R', 'Initials': 'MR', 'LastName': 'Albertini', 'Affiliation': 'University of Wisconsin Carbone Cancer Center (UWCCC), Madison, Wisconsin.'}, {'ForeName': 'Javed', 'Initials': 'J', 'LastName': 'Khan', 'Affiliation': 'Oncogenomics Section, Genetics Branch, NCI, NIH, Bethesda, Maryland. pmsondel@humonc.wisc.edu khanjav@mail.nih.gov.'}, {'ForeName': 'Paul M', 'Initials': 'PM', 'LastName': 'Sondel', 'Affiliation': 'Department of Human Oncology, University of Wisconsin-Madison, Madison, Wisconsin. pmsondel@humonc.wisc.edu khanjav@mail.nih.gov.'}]",Clinical cancer research : an official journal of the American Association for Cancer Research,['10.1158/1078-0432.CCR-19-3294'] 3251,30409707,History of Atrial Fibrillation and Trajectory of Decongestion in Acute Heart Failure.,"OBJECTIVES This study sought to characterize the course of decongestion among patients hospitalized for acute heart failure (AHF) by history of atrial fibrillation (AF) and/or atrial flutter (AFL). BACKGROUND AF/AFL and chronic heart failure (HF) commonly coexist. Little is known regarding the impact of AF/AFL on relief of congestion among patients who develop AHF. METHODS We pooled patients from 3 randomized trials of AHF conducted within the Heart Failure Network, the DOSE (Diuretic Optimization Strategies) trial, the ROSE (Renal Optimization Strategies) trial, and the CARRESS-HF (Cardiorenal Rescue Study in Acute Decompensated Heart Failure) trial. The association between history of AF/AFL and in-hospital changes in various metrics of congestion was assessed using covariate-adjusted linear and ordinal logistic regression models. RESULTS Of 750 unique patients, 418 (56%) had a history of AF/AFL. Left ventricular ejection fraction was higher (35% vs. 27%, respectively; p < 0.001), and N-terminal pro-brain natriuretic peptide (NT-proBNP) levels were nonsignificantly lower at baseline (4,210 pg/ml vs. 5,037 pg/ml, respectively; p = 0.27) in patients with AF/AFL. After adjustment of covariates, history of AF/AFL was associated with less substantial loss of weight (-5.7% vs. -6.5%, respectively; p = 0.02) and decrease in NT-proBNP levels (-18.7% vs. -31.3%, respectively; p = 0.003) by 72 or 96 h. History of AF/AFL was also associated with a blunted increase in global sense of well being at 72 or 96 h (p = 0.04). There was no association between history of AF/AFL and change in orthodema congestion score (p = 0.67) or 60-day composite clinical endpoint (all-cause mortality or any rehospitalization; hazard ratio: 1.21; 95% confidence interval: 0.92 to 1.59; p = 0.17). CONCLUSIONS More than half of the patients admitted with AHF had a history of AF/AFL. History of AF/AFL was independently associated with a blunted course of in-hospital decongestion. Further research is required to understand the utility of specific therapies targeting AF/AFL during hospitalization for AHF.",2019,"Left ventricular ejection fraction was higher (35% vs. 27%, respectively; p < 0.001), and N-terminal pro-brain natriuretic peptide (NT-proBNP) levels were nonsignificantly lower at baseline (4,210 pg/ml vs. 5,037 pg/ml, respectively; p = 0.27) in patients with AF/AFL.","['Of 750 unique patients, 418 (56%) had a history of AF/AFL', 'patients hospitalized for acute heart failure (AHF) by history of atrial fibrillation (AF) and/or atrial flutter (AFL', 'patients who develop AHF']",[],"['global sense', 'Left ventricular ejection fraction', 'substantial loss of weight', 'NT-proBNP levels', 'history of AF/AFL and change in orthodema congestion score', 'N-terminal pro-brain natriuretic peptide (NT-proBNP) levels']","[{'cui': 'C4517868', 'cui_str': '750 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0264714', 'cui_str': 'Acute heart failure (disorder)'}, {'cui': 'C0729790', 'cui_str': 'H/O: atrial fibrillation'}, {'cui': 'C0004239', 'cui_str': 'Auricular Flutter'}, {'cui': 'C0015506', 'cui_str': 'coagulation factor VIII'}]",[],"[{'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0042508', 'cui_str': 'Ventricular Ejection Fraction'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C1963813', 'cui_str': 'NT-proBNP'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0700148', 'cui_str': 'Congestion (morphologic abnormality)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205088', 'cui_str': 'End-stage (qualifier value)'}, {'cui': 'C0754710', 'cui_str': 'Amino-terminal pro-brain natriuretic peptide'}]",,0.0650048,"Left ventricular ejection fraction was higher (35% vs. 27%, respectively; p < 0.001), and N-terminal pro-brain natriuretic peptide (NT-proBNP) levels were nonsignificantly lower at baseline (4,210 pg/ml vs. 5,037 pg/ml, respectively; p = 0.27) in patients with AF/AFL.","[{'ForeName': 'Ravi B', 'Initials': 'RB', 'LastName': 'Patel', 'Affiliation': 'Department of Medicine, Division of Cardiology, Northwestern University Feinberg School of Medicine, Chicago, Illinois. Electronic address: ravi.patel@northwestern.edu.'}, {'ForeName': 'Muthiah', 'Initials': 'M', 'LastName': 'Vaduganathan', 'Affiliation': ""Heart and Vascular Center, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Aruna', 'Initials': 'A', 'LastName': 'Rikhi', 'Affiliation': 'Duke Clinical Research Institute, Durham, North Carolina.'}, {'ForeName': 'Hrishikesh', 'Initials': 'H', 'LastName': 'Chakraborty', 'Affiliation': 'Duke Clinical Research Institute, Durham, North Carolina.'}, {'ForeName': 'Stephen J', 'Initials': 'SJ', 'LastName': 'Greene', 'Affiliation': 'Duke Clinical Research Institute, Durham, North Carolina; Division of Cardiology, Duke University Medical Center, Durham, North Carolina.'}, {'ForeName': 'Adrian F', 'Initials': 'AF', 'LastName': 'Hernandez', 'Affiliation': 'Duke Clinical Research Institute, Durham, North Carolina; Division of Cardiology, Duke University Medical Center, Durham, North Carolina.'}, {'ForeName': 'G Michael', 'Initials': 'GM', 'LastName': 'Felker', 'Affiliation': 'Duke Clinical Research Institute, Durham, North Carolina; Division of Cardiology, Duke University Medical Center, Durham, North Carolina.'}, {'ForeName': 'Margaret M', 'Initials': 'MM', 'LastName': 'Redfield', 'Affiliation': 'Department of Cardiovascular Diseases, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Javed', 'Initials': 'J', 'LastName': 'Butler', 'Affiliation': 'Department of Medicine, University of Mississippi School of Medicine, Jackson, Mississippi.'}, {'ForeName': 'Sanjiv J', 'Initials': 'SJ', 'LastName': 'Shah', 'Affiliation': 'Department of Medicine, Division of Cardiology, Northwestern University Feinberg School of Medicine, Chicago, Illinois.'}]",JACC. Heart failure,['10.1016/j.jchf.2018.09.008'] 3252,30579673,Determinants and the Role of Self-Efficacy in a Sodium-Reduction Trial in Hemodialysis Patients.,"OBJECTIVE This study was to assess the impact of baseline dietary self-efficacy on the effect of a dietary intervention to reduce sodium intake in patients undergoing hemodialysis (HD) and to identify determinants of low dietary self-efficacy. METHODS This is a post hoc analysis of the BalanceWise study, a randomized controlled trial that aimed to reduce dietary sodium intake in HD patients recruited from 17 dialysis centers in Pennsylvania. The main outcome measures include dietary self-efficacy and reported dietary sodium density. Analysis of variance with post hoc group-wise comparison was used to examine the effect of baseline dietary self-efficacy on changes in reported sodium density in the intervention and control groups at 8 and 16 weeks. Chi-square test, independent t tests, or Wilcoxon rank-sum tests were used to identify determinants of low dietary self-efficacy. RESULTS The interaction between dietary self-efficacy and the impact of the intervention on changes in reported dietary sodium density approached significance at 8 and 16 weeks (P interaction = 0.051 and 0.06, respectively). Younger age and perceived income inadequacy were significantly associated with low self-efficacy in patients undergoing HD. CONCLUSION The benefits of dietary interventions designed to improve self-efficacy may differ by the baseline self-efficacy status. This may be particularly important for HD patients who are younger and report inadequate income as they had lower dietary self-efficacy.",2019,"The interaction between dietary self-efficacy and the impact of the intervention on changes in reported dietary sodium density approached significance at 8 and 16 weeks (P interaction = 0.051 and 0.06, respectively).","['patients undergoing hemodialysis (HD', 'HD patients who are younger and report inadequate income', 'HD patients recruited from 17 dialysis centers in Pennsylvania', 'Hemodialysis Patients']",['dietary intervention'],"['self-efficacy', 'dietary self-efficacy and reported dietary sodium density']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0019004', 'cui_str': 'Hemodialysis'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0205412', 'cui_str': 'Inadequate (qualifier value)'}, {'cui': 'C0021162', 'cui_str': 'Income'}, {'cui': 'C4551529', 'cui_str': 'Renal Dialysis'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0030853', 'cui_str': 'Pennsylvania'}]",[],"[{'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0037570', 'cui_str': 'Sodium, Dietary'}, {'cui': 'C0178587', 'cui_str': 'Mass to volume ratio'}]",,0.0354234,"The interaction between dietary self-efficacy and the impact of the intervention on changes in reported dietary sodium density approached significance at 8 and 16 weeks (P interaction = 0.051 and 0.06, respectively).","[{'ForeName': 'Lu', 'Initials': 'L', 'LastName': 'Hu', 'Affiliation': 'New York University School of Medicine, Center for Healthful Behavior Change, New York, New York. Electronic address: lu.hu@nyumc.org.'}, {'ForeName': 'David E', 'Initials': 'DE', 'LastName': 'St-Jules', 'Affiliation': 'New York University School of Medicine, Center for Healthful Behavior Change, New York, New York.'}, {'ForeName': 'Collin J', 'Initials': 'CJ', 'LastName': 'Popp', 'Affiliation': 'New York University School of Medicine, Center for Healthful Behavior Change, New York, New York.'}, {'ForeName': 'Mary Ann', 'Initials': 'MA', 'LastName': 'Sevick', 'Affiliation': 'New York University School of Medicine, Center for Healthful Behavior Change, New York, New York.'}]",Journal of renal nutrition : the official journal of the Council on Renal Nutrition of the National Kidney Foundation,['10.1053/j.jrn.2018.10.006'] 3253,31794928,"Concurrent cisplatin or cetuximab with radiotherapy for HPV-positive oropharyngeal cancer: Medical resource use, costs, and quality-adjusted survival from the De-ESCALaTE HPV trial.","BACKGROUND The De-ESCALaTE HPV trial confirmed the dominance of cisplatin over cetuximab for tumour control in patients with human papillomavirus (HPV)-positive oropharyngeal squamous cell carcinoma (OPSCC). Here, we present the analysis of health-related quality of life (HRQoL), resource use, and health care costs in the trial, as well as complete 2-year survival and recurrence. MATERIALS AND METHODS Resource use and HRQoL data were collected at intervals from the baseline to 24 months post treatment (PT). Health care costs were estimated using UK-based unit costs. Missing data were imputed. Differences in mean EQ-5D-5L utility index and adjusted cumulative quality-adjusted life years (QALYs) were compared using the Wilcoxon signed-rank test and linear regression, respectively. Mean resource usage and costs were compared through two-sample t-tests. RESULTS 334 patients were randomised to cisplatin (n = 166) or cetuximab (n = 168). Two-year overall survival (97·5% vs 90·0%, HR: 3.268 [95% CI 1·451 to 7·359], p = 0·0251) and recurrence rates (6·4% vs 16·0%, HR: 2·67 [1·38 to 5·15]; p = 0·0024) favoured cisplatin. No significant differences in EQ-5D-5L utility scores were detected at any time point. At 24 months PT, mean difference was 0·107 QALYs in favour of cisplatin (95% CI: 0·186 to 0·029, p = 0·007) driven by the mortality difference. Health care costs were similar across all categories except the procurement cost and delivery of the systemic agent, with cetuximab significantly more expensive than cisplatin (£7779 [P < 0.001]). Consequently, total costs at 24 months PT averaged £13517 (SE: £345) per patient for cisplatin and £21064 (SE: £400) for cetuximab (mean difference £7547 [95% CI: £6512 to £8582]). CONCLUSIONS Cisplatin chemoradiotherapy provided more QALYs and was less costly than cetuximab bioradiotherapy, remaining standard of care for nonsurgical treatment of HPV-positive OPSCC.",2020,"At 24 months PT, mean difference was 0·107 QALYs in favour of cisplatin","['HPV-positive oropharyngeal cancer', '334 patients', 'patients with human papillomavirus (HPV)-positive oropharyngeal squamous cell carcinoma (OPSCC']","['Cisplatin chemoradiotherapy', 'cetuximab', 'Concurrent cisplatin or cetuximab with radiotherapy', 'cisplatin over cetuximab', 'cisplatin']","['total costs', 'mean EQ-5D-5L utility index and adjusted cumulative quality-adjusted life years (QALYs', 'Mean resource usage and costs', 'health-related quality of life (HRQoL), resource use, and health care costs', 'EQ-5D-5L utility scores', 'overall survival', 'Health care costs', 'recurrence rates', '2-year survival and recurrence']","[{'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C2349952', 'cui_str': 'Cancer of Oropharnyx'}, {'cui': 'C4517729', 'cui_str': '334'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C0280313', 'cui_str': 'Cancer of oropharynx, squamous cell'}]","[{'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0436307', 'cui_str': 'Radiochemotherapy'}, {'cui': 'C0995188', 'cui_str': 'cetuximab'}, {'cui': 'C0205420', 'cui_str': 'Concurrent (qualifier value)'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0080071', 'cui_str': 'QALY'}, {'cui': 'C0035201', 'cui_str': 'Resources'}, {'cui': 'C0457083', 'cui_str': 'Usage (attribute)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}, {'cui': 'C1947944', 'cui_str': 'Use'}, {'cui': 'C0085552', 'cui_str': 'Healthcare Costs'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]",334.0,0.224792,"At 24 months PT, mean difference was 0·107 QALYs in favour of cisplatin","[{'ForeName': 'David A', 'Initials': 'DA', 'LastName': 'Jones', 'Affiliation': 'Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Oxford, UK.'}, {'ForeName': 'Pankaj', 'Initials': 'P', 'LastName': 'Mistry', 'Affiliation': 'Warwick Clinical Trials Unit, University of Warwick, Coventry, UK.'}, {'ForeName': 'Matthew', 'Initials': 'M', 'LastName': 'Dalby', 'Affiliation': 'Warwick Clinical Trials Unit, University of Warwick, Coventry, UK.'}, {'ForeName': 'Tessa', 'Initials': 'T', 'LastName': 'Fulton-Lieuw', 'Affiliation': 'Institute of Head and Neck Studies and Education, Institute of Cancer and Genomic Sciences, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Anthony H', 'Initials': 'AH', 'LastName': 'Kong', 'Affiliation': 'Institute of Head and Neck Studies and Education, Institute of Cancer and Genomic Sciences, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Janet', 'Initials': 'J', 'LastName': 'Dunn', 'Affiliation': 'Warwick Clinical Trials Unit, University of Warwick, Coventry, UK.'}, {'ForeName': 'Hisham M', 'Initials': 'HM', 'LastName': 'Mehanna', 'Affiliation': 'Institute of Head and Neck Studies and Education, Institute of Cancer and Genomic Sciences, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK.'}, {'ForeName': 'Alastair M', 'Initials': 'AM', 'LastName': 'Gray', 'Affiliation': 'Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Oxford, UK. Electronic address: alastair.gray@dph.ox.ac.uk.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2019.10.025'] 3254,31179007,"Geographically linked risk factors for enrolment into a fast breathing child pneumonia trial in Lilongwe, Malawi: an Innovative Treatments in Pneumonia (ITIP) secondary analysis.","Background Pneumonia is the leading infectious killer of children less than 5 years of age worldwide. In addition to vaccines that help prevent pneumonia, understanding the environmental and socioeconomic risk factors for child pneumonia is critical to further prevention. Methods Data from children with fast breathing pneumonia enrolled in a non-inferiority clinical trial assessing the effectiveness of 3-day placebo versus antibiotic treatment in Lilongwe, Malawi were used to examine environmental and socioeconomic characteristics within the study population. Location of residence was collected for enrolled children, and spatial enrolment rates were compared across Lilongwe using a spatial scan statistic. Results Data from 1101 children were analysed. Three urban subdistricts (locally known as 'Areas') (Areas 24, 36 and 38) out of 51 were identified with higher than expected enrolment. These three areas were associated with higher rates of poverty (37.8% vs 23.9%) as well as informal settlements and poorer sanitation (42.4% vs 7.4%) than other areas. Parents of enrolled children from these areas also had lower rates of secondary education compared with parents of children enrolled from other areas (55% vs 67% (p<0.01) among fathers; 47% vs 54% (p<0.01) among mothers). Conclusion In Lilongwe, areas with higher rates of poverty, informal settlements and poor sanitation contributed higher than expected enrolment of children to our fast breathing child pneumonia clinical trial when compared with other areas. Additional research is needed to evaluate the impact of environmental and socioeconomic risk factors, along with vaccination status, on the incidence of fast breathing pneumonia in children living in this region.",2019,"Parents of enrolled children from these areas also had lower rates of secondary education compared with parents of children enrolled from other areas (55% vs 67% (p<0.01) among fathers; 47% vs 54% (p<0.01) among mothers). ","['children with fast breathing pneumonia enrolled in a non-inferiority clinical trial', 'children living in this region', ""Three urban subdistricts (locally known as 'Areas"", '1101 children']",['placebo'],['rates of poverty'],"[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0035203', 'cui_str': 'Breathing'}, {'cui': 'C0032285', 'cui_str': 'Pneumonia'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0205309', 'cui_str': 'Known (qualifier value)'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0032854', 'cui_str': 'Poverty'}]",1101.0,0.0410504,"Parents of enrolled children from these areas also had lower rates of secondary education compared with parents of children enrolled from other areas (55% vs 67% (p<0.01) among fathers; 47% vs 54% (p<0.01) among mothers). ","[{'ForeName': 'Evangelyn', 'Initials': 'E', 'LastName': 'Nkwopara', 'Affiliation': 'International Programs, Save the Children Federation, Fairfield, Connecticut, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Schmicker', 'Affiliation': 'Biostatistics, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Tisungane', 'Initials': 'T', 'LastName': 'Mvalo', 'Affiliation': 'University of North Carolina Project, Lilongwe, Central Region, Malawi.'}, {'ForeName': 'Susanne', 'Initials': 'S', 'LastName': 'May', 'Affiliation': 'Biostatistics, University of Washington, Seattle, Washington, USA.'}, {'ForeName': 'Amy Sarah', 'Initials': 'AS', 'LastName': 'Ginsburg', 'Affiliation': 'International Programs, Save the Children Federation, Fairfield, Connecticut, USA.'}]",BMJ open respiratory research,['10.1136/bmjresp-2019-000414'] 3255,31179008,"Rationale, design and objectives of two phase III, randomised, placebo-controlled studies of GLPG1690, a novel autotaxin inhibitor, in idiopathic pulmonary fibrosis (ISABELA 1 and 2).","Introduction While current standard of care (SOC) for idiopathic pulmonary fibrosis (IPF) slows disease progression, prognosis remains poor. Therefore, an unmet need exists for novel, well-tolerated agents that reduce lung function decline and improve quality of life. Here we report the design of two phase III studies of the novel IPF therapy, GLPG1690. Methods and analysis Two identically designed, phase III, international, randomised, double-blind, placebo-controlled, parallel-group, multicentre studies (ISABELA 1 and 2) were initiated in November 2018. It is planned that, in each study, 750 subjects with IPF will be randomised 1:1:1 to receive oral GLPG1690 600 mg, GLPG1690 200 mg or placebo, once daily, on top of local SOC, for at least 52 weeks. The primary endpoint is rate of decline of forced vital capacity (FVC) over 52 weeks. Key secondary endpoints are week 52 composite endpoint of disease progression or all-cause mortality (defined as composite endpoint of first occurrence of ≥10% absolute decline in per cent predicted FVC or all-cause mortality at week 52); time to first respiratory-related hospitalisation until end of study; and week 52 change from baseline in the St George's Respiratory Questionnaire total score (a quality-of-life measure). Ethics and dissemination Studies will be conducted in accordance with Good Clinical Practice guidelines, Declaration of Helsinki principles, and local ethical and legal requirements. Results will be reported in a peer-reviewed publication. Trial registration numbers NCT03711162; NCT03733444.",2019,The primary endpoint is rate of decline of forced vital capacity (FVC) over 52 weeks.,['750 subjects with IPF'],"['novel IPF therapy, GLPG1690', 'Introduction\n\n\nWhile current standard of care (SOC', 'placebo', 'oral GLPG1690 600 mg, GLPG1690 200 mg or placebo', 'GLPG1690']","[""disease progression or all-cause mortality (defined as composite endpoint of first occurrence of ≥10% absolute decline in per cent predicted FVC or all-cause mortality at week 52); time to first respiratory-related hospitalisation until end of study; and week 52 change from baseline in the St George's Respiratory Questionnaire total score (a quality-of-life measure"", 'rate of decline of forced vital capacity (FVC', 'quality of life']","[{'cui': 'C4517868', 'cui_str': '750 (qualifier value)'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C4508131', 'cui_str': 'GLPG1690'}, {'cui': 'C1293116', 'cui_str': 'Introduction'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C2936643', 'cui_str': 'Standard of Care'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C4319558', 'cui_str': '200'}]","[{'cui': 'C0242656', 'cui_str': 'Disease Progression'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C2745955', 'cui_str': 'Occurrences (qualifier value)'}, {'cui': 'C0205344', 'cui_str': 'Absolute (qualifier value)'}, {'cui': 'C0562018', 'cui_str': 'cent (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C1272693', 'cui_str': 'Ended'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C3714541', 'cui_str': 'Forced Vital Capacity'}]",750.0,0.333205,The primary endpoint is rate of decline of forced vital capacity (FVC) over 52 weeks.,"[{'ForeName': 'Toby M', 'Initials': 'TM', 'LastName': 'Maher', 'Affiliation': 'NIHR Respiratory Clinical Research Facility, Royal Brompton Hospital, and Fibrosis Research Group, National Heart and Lung Institute, Imperial College, London, UK.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Kreuter', 'Affiliation': 'Centre for Interstitial and Rare Lung Diseases, Thoraxklinik, University Hospital Heidelberg, and German Center for Lung Research, Heidelberg, Germany.'}, {'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Lederer', 'Affiliation': 'Department of Medicine, Columbia University Irving Medical Center, New York City, New York, USA.'}, {'ForeName': 'Kevin K', 'Initials': 'KK', 'LastName': 'Brown', 'Affiliation': 'Department of Medicine, National Jewish Health, Denver, Colorado, USA.'}, {'ForeName': 'Wim', 'Initials': 'W', 'LastName': 'Wuyts', 'Affiliation': 'Unit for Interstitial Lung Diseases, Department of Pulmonary Medicine, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'Nadia', 'Initials': 'N', 'LastName': 'Verbruggen', 'Affiliation': 'Galapagos NV, Mechelen, Belgium.'}, {'ForeName': 'Simone', 'Initials': 'S', 'LastName': 'Stutvoet', 'Affiliation': 'Galapagos NV, Mechelen, Belgium.'}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Fieuw', 'Affiliation': 'Galapagos NV, Mechelen, Belgium.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Ford', 'Affiliation': 'Galapagos NV, Mechelen, Belgium.'}, {'ForeName': 'Walid', 'Initials': 'W', 'LastName': 'Abi-Saab', 'Affiliation': 'Galapagos NV, Mechelen, Belgium.'}, {'ForeName': 'Marlies', 'Initials': 'M', 'LastName': 'Wijsenbeek', 'Affiliation': 'Department of Respiratory Medicine, Erasmus MC, University Medical Centre Rotterdam, Rotterdam, The Netherlands.'}]",BMJ open respiratory research,['10.1136/bmjresp-2019-000422'] 3256,31053405,The addition of paclitaxel to doxorubicin and cisplatin and volume-directed radiation does not improve overall survival (OS) or long-term recurrence-free survival (RFS) in advanced endometrial cancer (EC): A randomized phase III NRG/Gynecologic Oncology Group (GOG) study.,"OBJECTIVES To determine if the addition of paclitaxel (P) to cisplatin and doxorubicin (CD) following surgical debulking and volume-directed radiation therapy improved long-term, recurrence-free survival (RFS) and overall survival (OS) in patients with advanced-stage endometrial cancer (EC). METHODS Prospective, randomized GOG trial comparing (CD) (50 mg/m 2 )/(45 mg/m 2 ) +/- (P) (160 mg/m 2 ) following volume-directed radiation and surgery in advanced EC. A Kaplan-Meier (KM) analysis characterized the relationship between treatment arms and the OS outcome, a log-rank test assessed the independence of treatment with the OS outcome, and the treatment effect on estimated OS was determined using a Cox proportional hazards (PH) model stratified by stage. The PH assumption was assessed using a test of interaction between treatment variable and the natural logarithm of survival time. Adverse events, regardless of attribution, were graded. RESULTS Since initial publication, 60 deaths occurred, leaving 311 patients alive with 290 (93.8%) recurrence- free. There was no significant decrease in the risk of recurrence or death associated with the CDP treatment regimen stratified for stage (p = 0.14, one-tail). The exploratory analysis for OS and the corresponding homogeneity tests for different effects across subgroups revealed only EFRT and EFRT & GRD status to have significantly different treatment effects (p = 0.027 and p = 0.017, respectively). Second primary malignancies were identified in 17/253 (6.4%) and 19/263 (7.0%) of patients treated with CD and CDP respectively. Breast (2.4%) followed by colon (1%) were the two cancers most frequently diagnosed in this setting. CONCLUSION No significant difference between treatment arms was identified. Subgroup analysis both in the initial and current reports demonstrated a trend towards improved RFS and OS in patients treated with CDP and EFRT. This long-term analysis of outcomes also identified the necessity of providing on-going cancer screening to patients enrolled in trials.",2019,"There was no significant decrease in the risk of recurrence or death associated with the CDP treatment regimen stratified for stage (p = 0.14, one-tail).","['patients with advanced-stage endometrial cancer (EC', 'patients enrolled in trials', 'advanced endometrial cancer (EC']","['surgical debulking and volume-directed radiation therapy', 'paclitaxel to doxorubicin and cisplatin and volume-directed radiation', 'paclitaxel (P) to cisplatin and doxorubicin (CD', 'CD) (50\u202fmg/m 2 )/(45']","['overall survival (OS) or long-term recurrence-free survival (RFS', 'long-term, recurrence-free survival (RFS) and overall survival (OS', 'risk of recurrence or death', 'RFS and OS', 'natural logarithm of survival time']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C1306673', 'cui_str': 'Stages (qualifier value)'}, {'cui': 'C0476089', 'cui_str': 'Endometrial Carcinoma'}]","[{'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0439851', 'cui_str': 'Direct (qualifier value)'}, {'cui': 'C0034619', 'cui_str': 'radiation therapy'}, {'cui': 'C0144576', 'cui_str': 'Paclitaxel'}, {'cui': 'C0013089', 'cui_str': 'Doxorubicin'}, {'cui': 'C0008838', 'cui_str': 'Cisplatin'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}]","[{'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0205166', 'cui_str': 'Long (qualifier value)'}, {'cui': 'C2919733', 'cui_str': 'Surviving free of recurrence of neoplastic disease (finding)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205296', 'cui_str': 'Natural (qualifier value)'}, {'cui': 'C2919552', 'cui_str': 'Survival time'}]",,0.274433,"There was no significant decrease in the risk of recurrence or death associated with the CDP treatment regimen stratified for stage (p = 0.14, one-tail).","[{'ForeName': 'Nick M', 'Initials': 'NM', 'LastName': 'Spirtos', 'Affiliation': ""Women's Cancer Center, Las Vegas, NV 89169, United States of America. Electronic address: nspirtos@wccenter.com.""}, {'ForeName': 'Danielle', 'Initials': 'D', 'LastName': 'Enserro', 'Affiliation': 'NRG Oncology, Clinical Trial Development Division, Biostatistics & Bioinformatics, Roswell Park Comprehensive Cancer Center, Buffalo, NY 14263, United States of America. Electronic address: denserro@gogstats.org.'}, {'ForeName': 'Howard D', 'Initials': 'HD', 'LastName': 'Homesley', 'Affiliation': 'Gynecologic Oncology Network/Brody School of Medicine, Division of Gynecologic Oncology, Leo Jenkins Cancer Center, Greenville, NC 28734, United States of America.'}, {'ForeName': 'Susan K', 'Initials': 'SK', 'LastName': 'Gibbons', 'Affiliation': 'Albany Medical Center, Dept. of Radiation Oncology, Albany, NY 12208, United States of America. Electronic address: gibbons@mail.amc.edu.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Cella', 'Affiliation': 'Northwestern University, Dept. of Medical Social Sciences, Feinberg School of Medicine, Chicago, IL 60201, United States of America. Electronic address: d-cella@northwestern.edu.'}, {'ForeName': 'Robert T', 'Initials': 'RT', 'LastName': 'Morris', 'Affiliation': 'Wayne State University, Dept. of Gynecologic Oncology, Detroit, MI 48201, United States of America. Electronic address: rmorris@med.wayne.edu.'}, {'ForeName': 'Koen', 'Initials': 'K', 'LastName': 'DeGeest', 'Affiliation': 'University of Iowa Hospitals and Clinics, Iowa City, IA, United States of America. Electronic address: degeest@ohsu.edu.'}, {'ForeName': 'Roger B', 'Initials': 'RB', 'LastName': 'Lee', 'Affiliation': 'Obstetrics & Gynecology, Tacoma General Hospital, Tacoma, WA, United States of America.'}, {'ForeName': 'David S', 'Initials': 'DS', 'LastName': 'Miller', 'Affiliation': 'Division of Gynecologic Oncology, UT Southwestern Medical Center at Dallas, Dallas, TX 75390-9032, United States of America. Electronic address: David.Miller@utsouthwestern.edu.'}]",Gynecologic oncology,['10.1016/j.ygyno.2019.03.240'] 3257,31936725,The Impact of Sprint Interval Training Frequency on Blood Glucose Control and Physical Function of Older Adults.,"Exercise is a powerful tool for improving health in older adults, but the minimum frequency required is not known. This study sought to determine the effect of training frequency of sprint interval training (SIT) on health and physical function in older adults. Thirty-four (13 males and 21 females) older adults (age 65 ± 4 years) were recruited. Participants were allocated to a control group (CON n = 12) or a once- ( n = 11) or twice- ( n = 11) weekly sprint interval training (SIT) groups. The control group maintained daily activities; the SIT groups performed 8 weeks of once- or twice-weekly training sessions consisting of 6 s sprints. Metabolic health (oral glucose tolerance test), aerobic capacity (walk test) and physical function (get up and go test, sit to stand test) were determined before and after training. Following training, there were significant improvements in blood glucose control, physical function and aerobic capacity in both training groups compared to control, with changes larger than the smallest worthwhile change. There was a small to moderate effect for blood glucose ( d = 0.43-0.80) and physical function ( d = 0.43-0.69) and a trivial effect for aerobic capacity ( d = 0.01) between the two training frequencies. Once a week training SIT is sufficient to produce health benefits. Therefore, the minimum time and frequency of exercise required is much lower than currently recommended.",2020,"Following training, there were significant improvements in blood glucose control, physical function and aerobic capacity in both training groups compared to control, with changes larger than the smallest worthwhile change.","['Thirty-four (13 males and 21 females) older adults (age 65 ± 4 years', 'older adults', 'Older Adults']","['sprint interval training (SIT', 'Exercise', 'Sprint Interval Training Frequency', 'control group (CON n = 12) or a once- ( n = 11) or twice- ( n = 11) weekly sprint interval training (SIT']","['trivial effect for aerobic capacity', 'health and physical function', 'blood glucose', 'Blood Glucose Control and Physical Function', 'Metabolic health (oral glucose tolerance test), aerobic capacity (walk test) and physical function (get up and go test, sit to stand test', 'physical function', 'blood glucose control, physical function and aerobic capacity']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C4279979', 'cui_str': 'Sprint Interval Training'}, {'cui': 'C2584297', 'cui_str': 'Seated Position'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C1720725', 'cui_str': 'Twice'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}]","[{'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0005802', 'cui_str': 'Blood Sugar'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0029161', 'cui_str': 'Oral Glucose Tolerance'}, {'cui': 'C4277740', 'cui_str': 'Walk Test'}, {'cui': 'C1303170', 'cui_str': 'Get up and go test'}, {'cui': 'C2584297', 'cui_str': 'Seated Position'}, {'cui': 'C3888057', 'cui_str': 'Stand'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}]",,0.00945242,"Following training, there were significant improvements in blood glucose control, physical function and aerobic capacity in both training groups compared to control, with changes larger than the smallest worthwhile change.","[{'ForeName': 'Simon', 'Initials': 'S', 'LastName': 'Adamson', 'Affiliation': 'Division of Sport and Exercise Sciences, Abertay University, Dundee DD1 1HG, UK.'}, {'ForeName': 'Mykolas', 'Initials': 'M', 'LastName': 'Kavaliauskas', 'Affiliation': 'School of Applied Sciences, Sport, Exercise and Health Sciences, Edinburgh Napier University, Edinburgh EH11 4DY, UK.'}, {'ForeName': 'Ross', 'Initials': 'R', 'LastName': 'Lorimer', 'Affiliation': 'Division of Sport and Exercise Sciences, Abertay University, Dundee DD1 1HG, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Babraj', 'Affiliation': 'Division of Sport and Exercise Sciences, Abertay University, Dundee DD1 1HG, UK.'}]",International journal of environmental research and public health,['10.3390/ijerph17020454'] 3258,32046910,Quality of life and the associated risk of all-cause mortality in nonischemic heart failure.,"OBJECTIVES To examine the association between health-related quality of life (HRQoL) and mortality in patients with heart failure (HF). BACKGROUND The potential association of HRQoL and mortality in patients with HF is unclear. We investigated this association in The Danish Study to Assess the Efficacy of Implantable Cardioverter Defibrillators (ICD) in Patients with Non-ischemic Systolic Heart Failure on Mortality (DANISH). METHODS In DANISH, a total of 1116 patients with non-ischemic systolic HF on guideline-recommended therapy were randomized to ICD therapy or usual clinical care. HRQoL was assessed at randomization using the disease-specific Minnesota Living with Heart Failure Questionnaire (MLHFQ, 0-105, high score indicating worse HRQoL). Multivariable Cox proportional hazard models were used to compare hazard ratios (HR) for all-cause mortality according to MLHFQ above or below 45, as recommended by a recent meta-analysis, to identify patients with poor HRQoL. RESULTS HRQoL was completed by 935 (84%) patients at baseline with a median follow-up of 67 months (IQR 47-83). Patients with poor HRQoL (MLHFQ score > 45, median 60 (IQR 53-71),n = 350) had a higher incidence of all-cause mortality than patients with moderate/good HRQoL (MLHFQ ≤45, median 23 (IQR 13-33), n = 585), respectively 26% vs. 18% with an unadjusted HR of 1.57 (95% CI 1.19-2.08, p = .002), and an adjusted HR of 1.39 (95% CI 1.01-1.91, p = .04). CONCLUSION Poor HRQoL was associated with an increased risk of all-cause mortality after adjustment for traditional risk factors. CLINICAL TRIAL REGISTRATION https: //clinicaltrials.gov/ct2/show/NCT00542945(DANISH).",2020,"Poor HRQoL was associated with an increased risk of all-cause mortality after adjustment for traditional risk factors. ","['Patients with poor HRQoL', 'nonischemic heart failure', '1116 patients with non-ischemic systolic HF on guideline-recommended therapy', 'Patients with Non-ischemic Systolic Heart Failure on Mortality (DANISH', 'patients with heart failure (HF', 'patients with HF']","['ICD therapy or usual clinical care', 'Implantable Cardioverter Defibrillators (ICD']","['Quality of life', 'HRQoL', 'health-related quality of life (HRQoL) and mortality']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0475224', 'cui_str': 'Ischemic (qualifier value)'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0220845', 'cui_str': 'guidelines'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C1135191', 'cui_str': 'Heart Failure, Systolic'}, {'cui': 'C0026566', 'cui_str': 'mortality'}]","[{'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0162589', 'cui_str': 'Implantable Cardioverter-Defibrillators'}]","[{'cui': 'C0034380'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}]",1116.0,0.0761252,"Poor HRQoL was associated with an increased risk of all-cause mortality after adjustment for traditional risk factors. ","[{'ForeName': 'Johan S', 'Initials': 'JS', 'LastName': 'Bundgaard', 'Affiliation': 'Department of Cardiology, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark. Electronic address: johan.skov.bundgaard.01@regionh.dk.'}, {'ForeName': 'Jens J', 'Initials': 'JJ', 'LastName': 'Thune', 'Affiliation': 'Department of Cardiology, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark; Department of Cardiology, Bispebjerg Hospital, University of Copenhagen, Copenhagen, Denmark.'}, {'ForeName': 'Gunnar', 'Initials': 'G', 'LastName': 'Gislason', 'Affiliation': 'Department of Cardiovascular Epidemiology and Research, The Danish Heart Foundation, Copenhagen, Denmark; Department of Cardiology, Copenhagen University Hospital Herlev and Gentofte, Copenhagen, Denmark.'}, {'ForeName': 'Emil L', 'Initials': 'EL', 'LastName': 'Fosbøl', 'Affiliation': 'Department of Cardiology, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Christian', 'Initials': 'C', 'LastName': 'Torp-Pedersen', 'Affiliation': 'Department of Clinical Epidemiology, Department of Cardiology, Aalborg University Hospital, Aalborg, Denmark.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Aagaard', 'Affiliation': 'Department of Cardiology, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Jens C', 'Initials': 'JC', 'LastName': 'Nielsen', 'Affiliation': 'Department of Cardiology, Aarhus University Hospital, Aarhus, Denmark.'}, {'ForeName': 'Jens', 'Initials': 'J', 'LastName': 'Haarbo', 'Affiliation': 'Department of Cardiology, Copenhagen University Hospital Herlev and Gentofte, Copenhagen, Denmark.'}, {'ForeName': 'Anna M', 'Initials': 'AM', 'LastName': 'Thøgersen', 'Affiliation': 'Department of Clinical Epidemiology, Department of Cardiology, Aalborg University Hospital, Aalborg, Denmark.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Videbæk', 'Affiliation': 'Department of Cardiology, Odense University Hospital, Odense, Denmark.'}, {'ForeName': 'Gunnar', 'Initials': 'G', 'LastName': 'Jensen', 'Affiliation': 'Department of Cardiology, Zealand University Hospital, Roskilde, Denmark.'}, {'ForeName': 'Line L', 'Initials': 'LL', 'LastName': 'Olesen', 'Affiliation': 'Department of Cardiology, Zealand University Hospital, Roskilde, Denmark.'}, {'ForeName': 'Søren L', 'Initials': 'SL', 'LastName': 'Kristensen', 'Affiliation': 'Department of Cardiology, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Susanne S', 'Initials': 'SS', 'LastName': 'Pedersen', 'Affiliation': 'Department of Cardiology, Odense University Hospital, Odense, Denmark; Department of Psychology, University of Southern Denmark, Odense, Denmark.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Køber', 'Affiliation': 'Department of Cardiology, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark.'}, {'ForeName': 'Ulrik M', 'Initials': 'UM', 'LastName': 'Mogensen', 'Affiliation': 'Department of Cardiology, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark; Department of Cardiology, Zealand University Hospital, Roskilde, Denmark.'}]",International journal of cardiology,['10.1016/j.ijcard.2020.02.008'] 3259,31791384,Randomised controlled trial of the short-term effects of OROS-methylphenidate on ADHD symptoms and behavioural outcomes in young male prisoners with attention-deficit/hyperactivity disorder (CIAO-II).,"BACKGROUND Attention-deficit/hyperactivity disorder (ADHD) is a highly prevalent disorder, seen in 20-30% of young adult prisoners. Pharmacoepidemiological studies, a small randomised controlled trial and open trial data of methylphenidate suggest clinically significant reductions in ADHD symptoms, emotional dysregulation, disruptive behaviour and increased engagement with educational activities. Yet, routine treatment of ADHD in offenders is not yet established clinical practice. There is continued uncertainty about the clinical response to methylphenidate (MPH), a first-line treatment for ADHD, in offenders, who often present with an array of complex mental health problems that may be better explained by states of inattentive, overactive, restless and impulsive behaviours. To address this problem, we will conduct an efficacy trial to establish the short-term effects of osmotic-controlled release oral delivery system (OROS)-methylphenidate (Concerta XL), an extended release formulation of MPH, on ADHD symptoms, emotional dysregulation and behaviour. METHODS This study is a parallel-arm, randomised, placebo-controlled trial of OROS-MPH on ADHD symptoms, behaviour and functional outcomes in young male prisoners aged 16-25, meeting Diagnostic and Statistical Manual of Mental Disorders, fifth edition criteria for ADHD. Participants are randomised to 8 weeks of treatment with OROS-MPH or placebo, titrated over 5 weeks to balance ADHD symptom improvement against side effects. Two hundred participants will be recruited with a 1:1 ratio of drug to placebo. The primary outcome is change in level of ADHD symptoms after 8 weeks of trial medication. DISCUSSION Potential benefits include improvement in ADHD symptoms, emotional dysregulation, attitudes towards violence and critical incidents and increased engagement with educational and rehabilitation programmes. Demonstrating the efficacy and safety of MPH on ADHD symptoms and associated impairments may provide the data needed to develop effective healthcare pathways for a significant group of young offenders. Establishing efficacy of MPH in this population will provide the foundation needed to establish long-term effectiveness studies with the potential for demonstrating significant reductions in criminal behaviour and improved health-economic outcomes. TRIAL REGISTRATION ISRCTN registry, ISRCTN16827947, 31st May 2016; EudraCT number, 2015-004271-78, 31st May 2016. Last particpant last visit 6 June 2019. Data lock 27 August 2019.",2019,"DISCUSSION Potential benefits include improvement in ADHD symptoms, emotional dysregulation, attitudes towards violence and critical incidents and increased engagement with educational and rehabilitation programmes.","['young male prisoners with attention-deficit/hyperactivity disorder (CIAO-II', '31st May 2016; EudraCT number, 2015-004271-78, 31st May 2016', 'Two hundred participants will be recruited with a 1:1 ratio of drug to', 'young male prisoners aged 16-25, meeting Diagnostic and Statistical Manual of Mental Disorders, fifth edition criteria for ADHD']","['OROS-methylphenidate', 'methylphenidate', 'osmotic-controlled release oral delivery system (OROS)-methylphenidate (Concerta XL', 'OROS-MPH or placebo', 'MPH', 'placebo', 'OROS-MPH', 'methylphenidate (MPH']","['ADHD symptoms and behavioural outcomes', 'ADHD symptoms, emotional dysregulation, disruptive behaviour and increased engagement with educational activities', 'ADHD symptoms, behaviour and functional outcomes', 'change in level of ADHD symptoms']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0033167', 'cui_str': 'Prisoners'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C4319558', 'cui_str': '200'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1136324', 'cui_str': 'Diagnostic and Statistical Manual of Mental Disorders'}, {'cui': 'C0205439', 'cui_str': 'Fifth (qualifier value)'}, {'cui': 'C0441792', 'cui_str': 'Editions (qualifier value)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}]","[{'cui': 'C0025810', 'cui_str': 'Methylphenidate'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0449914', 'cui_str': 'Delivery system (attribute)'}, {'cui': 'C0939301', 'cui_str': 'Concerta'}, {'cui': 'C0048853', 'cui_str': 'MPH'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0474416', 'cui_str': 'Disruptive Behavior'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0013652', 'cui_str': 'Educational Activities'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",200.0,0.410468,"DISCUSSION Potential benefits include improvement in ADHD symptoms, emotional dysregulation, attitudes towards violence and critical incidents and increased engagement with educational and rehabilitation programmes.","[{'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Asherson', 'Affiliation': ""Institute of Psychiatry, Psychology and Neuroscience, King's College London, De Crespigny Park, London, SE5 8AF, UK. Philip.asherson@kcl.ac.uk.""}, {'ForeName': 'Lena', 'Initials': 'L', 'LastName': 'Johansson', 'Affiliation': ""Institute of Psychiatry, Psychology and Neuroscience, King's College London, De Crespigny Park, London, SE5 8AF, UK.""}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Holland', 'Affiliation': ""Institute of Psychiatry, Psychology and Neuroscience, King's College London, De Crespigny Park, London, SE5 8AF, UK.""}, {'ForeName': 'Tom', 'Initials': 'T', 'LastName': 'Fahy', 'Affiliation': ""Institute of Psychiatry, Psychology and Neuroscience, King's College London, De Crespigny Park, London, SE5 8AF, UK.""}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Forester', 'Affiliation': 'Healthcare Department, HM Prison Brixton, Jebb Avenue, London, SW2 5XF, UK.'}, {'ForeName': 'Sheila', 'Initials': 'S', 'LastName': 'Howitt', 'Affiliation': 'Division of Psychiatry, University of Edinburgh, Morningside Park, Edinburgh, EH10 5HF, UK.'}, {'ForeName': 'Stephen', 'Initials': 'S', 'LastName': 'Lawrie', 'Affiliation': 'Division of Psychiatry, University of Edinburgh, Morningside Park, Edinburgh, EH10 5HF, UK.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Strang', 'Affiliation': ""Institute of Psychiatry, Psychology and Neuroscience, King's College London, De Crespigny Park, London, SE5 8AF, UK.""}, {'ForeName': 'Susan', 'Initials': 'S', 'LastName': 'Young', 'Affiliation': 'Psychology Services Limited, PO1735, Croydon, CR0 7WA, UK.'}, {'ForeName': 'Sabine', 'Initials': 'S', 'LastName': 'Landau', 'Affiliation': ""Institute of Psychiatry, Psychology and Neuroscience, King's College London, De Crespigny Park, London, SE5 8AF, UK.""}, {'ForeName': 'Lindsay', 'Initials': 'L', 'LastName': 'Thomson', 'Affiliation': 'Division of Psychiatry, University of Edinburgh, Morningside Park, Edinburgh, EH10 5HF, UK.'}]",Trials,['10.1186/s13063-019-3705-9'] 3260,31630899,Effect of an 'implementation intention' intervention on adherence to oral anti-diabetic medication in Brazilians with type 2 diabetes.,"OBJECTIVE To evaluate the effects of an implementation intention intervention on adherence to an oral anti-diabetic medication regime, diabetes-related distress and on glycemic control in patients with type 2 diabetes mellitus. METHODS A randomized, parallel-group, single-center controlled trial was conducted among adults with type 2 diabetes being managed at the primary care level. The intervention group (IG, n = 45) received an 'implementation intention' intervention; the control group (CG, n = 45) received standard care. Primary outcomes were the taking of oral anti-diabetic medication, global adherence and level of glycated hemoglobin. The secondary outcome was diabetes-related distress. Data were gathered at baseline and after 15 weeks. RESULTS The IG showed improvements in adherence to an oral anti-diabetic medication regime (p < 0.0001), glycemic control (p < 0.0001) and diabetes-related distress (p < 0.0001) relative to the CG. CONCLUSIONS The implementation intention intervention enhanced adherence to an oral anti-diabetic medication regime, which had positive effects on blood glucose levels and diabetes-related distress. PRACTICE IMPLICATIONS Adherence to an oral anti-diabetic medication regime can decrease blood glucose levels and diabetes-related distress and thus reduce complications of type 2 diabetes.",2020,"The implementation intention intervention enhanced adherence to an oral anti-diabetic medication regime, which had positive effects on blood glucose levels and diabetes-related distress. ","['patients with type 2 diabetes mellitus', 'Brazilians with type 2 diabetes', 'adults with type 2 diabetes being managed at the primary care level']","['oral anti-diabetic medication regime', ""implementation intention' intervention"", 'implementation intention intervention', ""intervention group (IG, n\u2009=\u200945) received an 'implementation intention' intervention; the control group (CG, n\u2009=\u200945) received standard care""]","['blood glucose levels and diabetes-related distress', 'diabetes-related distress', 'adherence to an oral anti-diabetic medication regime', 'adherence to oral anti-diabetic medication', 'glycemic control', 'taking of oral anti-diabetic medication, global adherence and level of glycated hemoglobin']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0033137', 'cui_str': 'Primary Care'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]","[{'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C0162425', 'cui_str': 'Intention'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0428554', 'cui_str': 'Blood glucose result - finding'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0241863', 'cui_str': 'Diabetic'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}]",,0.0360605,"The implementation intention intervention enhanced adherence to an oral anti-diabetic medication regime, which had positive effects on blood glucose levels and diabetes-related distress. ","[{'ForeName': 'Danilo Donizetti', 'Initials': 'DD', 'LastName': 'Trevisan', 'Affiliation': 'School of Nursing - Federal University of São João del Rei, Divinópolis, Brazil. Electronic address: ddtrevisan@ufsj.edu.br.'}, {'ForeName': 'Thaís', 'Initials': 'T', 'LastName': 'São-João', 'Affiliation': 'School of Nursing - University of Campinas, Campinas, Brazil.'}, {'ForeName': 'Marilia', 'Initials': 'M', 'LastName': 'Cornélio', 'Affiliation': 'School of Nursing - University of Campinas, Campinas, Brazil.'}, {'ForeName': 'Fernanda', 'Initials': 'F', 'LastName': 'Jannuzzi', 'Affiliation': 'Technical School of Campinas - University of Campinas, Campinas, Brazil.'}, {'ForeName': 'Maria Rui', 'Initials': 'MR', 'LastName': 'de Sousa', 'Affiliation': 'Nursing School of Porto, Porto, Portugal.'}, {'ForeName': 'Roberta', 'Initials': 'R', 'LastName': 'Rodrigues', 'Affiliation': 'School of Nursing - University of Campinas, Campinas, Brazil.'}, {'ForeName': 'Maria Helena', 'Initials': 'MH', 'LastName': 'Lima', 'Affiliation': 'School of Nursing - University of Campinas, Campinas, Brazil.'}]",Patient education and counseling,['10.1016/j.pec.2019.10.003'] 3261,30882562,"Mediators of Physical Activity Behavior Change in the ""Girls on the Move"" Intervention.","BACKGROUND The minimal effect of interventions to date on increasing young adolescent girls' physical activity (PA) may be due to inadequate understanding of the mechanisms underlying behavior change, yet sparse research testing a PA intervention has examined the capacity of theories to explain PA, particularly when using objective measures. OBJECTIVES The aim of the study was to examine whether constructs from the health promotion model and self-determination theory mediated changes in moderate-to-vigorous physical activity (MVPA) following a 17-week intervention. METHODS The study was a secondary analysis of data from a group randomized trial, including 12 intervention and 12 control schools in the Midwestern United States. Data were collected in 2012-2016. Girls (fifth- to eighth-grade, N = 1,519) completed surveys on perceived benefits and enjoyment of PA, PA self-efficacy, social support and motivation for PA, and barriers to PA and wore accelerometers. RESULTS The final path model had a good fit: χ(4) = 2.48, p = .648; goodness-of-fit index = 1; comparative fit index = 1; root-mean-square error of approximation = 0; standardized root-mean-square residual = 0.01. For MVPA change from baseline to postintervention, enjoyment (B = 24.48, p < .001) and social support (B = 30.48, p < .001) had a positive direct effect, whereas the intervention had a positive indirect effect through enjoyment and social support (B = 9.13, p < .001). Enjoyment (B = -13.83, p < .001) and social support (B = -17.22, p < .001) had a negative indirect effect on MVPA change from postintervention to follow-up. DISCUSSION Enjoyment of PA and social support for PA may be important mediators of PA in young adolescent girls and warrant consideration when designing interventions.",2019,"For MVPA change from baseline to postintervention, enjoyment (B = 24.48, p < .001) and social support (B = 30.48, p < .001) had a positive direct effect, whereas the intervention had a positive indirect effect through enjoyment and social support (B = 9.13, p < .001).","['young adolescent girls', '12 intervention and 12 control schools in the Midwestern United States', ""young adolescent girls' physical activity (PA"", 'Girls (fifth- to eighth-grade, N = 1,519) completed surveys on perceived']",[],"['Physical Activity Behavior Change', 'positive indirect effect through enjoyment and social support', 'moderate-to-vigorous physical activity (MVPA', 'benefits and enjoyment of PA, PA self-efficacy, social support and motivation for PA, and barriers to PA and wore accelerometers', 'social support', 'MVPA change', 'Enjoyment']","[{'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0036375', 'cui_str': 'School'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0205439', 'cui_str': 'Fifth (qualifier value)'}, {'cui': 'C0205442', 'cui_str': 'Eighth (qualifier value)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}]",[],"[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0439852', 'cui_str': 'Indirect (qualifier value)'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0037438'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0026605', 'cui_str': 'Motivation'}, {'cui': 'C0173022', 'cui_str': 'Barrier (varnish)'}]",,0.0189297,"For MVPA change from baseline to postintervention, enjoyment (B = 24.48, p < .001) and social support (B = 30.48, p < .001) had a positive direct effect, whereas the intervention had a positive indirect effect through enjoyment and social support (B = 9.13, p < .001).","[{'ForeName': 'Lorraine B', 'Initials': 'LB', 'LastName': 'Robbins', 'Affiliation': ""Lorraine B. Robbins, PhD, RN, FNP-BC, FAAN, is Associate Professor, Michigan State University College of Nursing, East Lansing. Fujun Wen, MEd, is Master's Degree in Biostatistics Student, Michigan State University Department of Epidemiology and Biostatistics, East Lansing. Jiying Ling, PhD, RN, is Assistant Professor, Michigan State University College of Nursing, East Lansing.""}, {'ForeName': 'Fujun', 'Initials': 'F', 'LastName': 'Wen', 'Affiliation': ''}, {'ForeName': 'Jiying', 'Initials': 'J', 'LastName': 'Ling', 'Affiliation': ''}]",Nursing research,['10.1097/NNR.0000000000000359'] 3262,30281066,"A Phase 2, Randomized, Control Trial of Group B Streptococcus (GBS) Type III Capsular Polysaccharide-tetanus Toxoid (GBS III-TT) Vaccine to Prevent Vaginal Colonization With GBS III.","BACKGROUND Group B Streptococcus (GBS) frequently colonizes pregnant women and can cause sepsis and meningitis in young infants. If colonization was prevented through maternal immunization, a reduction in perinatal GBS disease might be possible. A GBS type III capsular polysaccharide (CPS)-tetanus toxoid conjugate (III-TT) vaccine was evaluated for safety and efficacy in preventing acquisition of GBS colonization. METHODS Healthy, nonpregnant women aged 18-40 years and screened to be GBS III vaginal and rectal culture negative were randomized to receive III-TT conjugate or tetanus diphtheria toxoid vaccine in a multicenter, observer-blinded trial. GBS vaginal and rectal cultures and blood were obtained bimonthly over 18 months. Serum concentrations of GBS III CPS-specific antibodies were determined using enzyme-linked immunosorbent assay. RESULTS Among 1525 women screened, 650 were eligible for the intent-to-treat analysis. For time to first acquisition of vaginal GBS III, vaccine efficacy was 36% (95% confidence interval [CI], 1%-58%; P = .044), and for first rectal acquisition efficacy was 43% (95% CI, 11% to 63%; P = .014). Two months post-immunization, geometric mean concentrations of serum GBS type III CPS-specific immunoglobulin G were 12.6 µg/mL (95% CI, 9.95 to 15.81) in GBS III-TT recipients, representing a 4-fold increase from baseline in 95% of women, which persisted. Both vaccines were well tolerated. CONCLUSIONS GBS CPS III-TT conjugate vaccine significantly delayed acquisition of vaginal and rectal GBS III colonization. In addition to its use for maternal immunization to passively protect infants with maternally derived antibodies, a multivalent vaccine might also serve to reduce fetal and neonatal exposure to GBS. CLINICAL TRIALS REGISTRATION NCT00128219.",2019,"Two months post-immunization, geometric mean concentrations of serum GBS type III CPS-specific immunoglobulin G were 12.6 µg/mL (95% CI, 9.95 to 15.81) in GBS III-TT recipients, representing a 4-fold increase from baseline in 95% of women, which persisted.","['Healthy, nonpregnant women aged 18-40 years and screened to be GBS III vaginal and rectal culture negative', '1525 women screened, 650 were eligible for the intent-to-treat analysis', 'young infants']","['Type III Capsular Polysaccharide-tetanus Toxoid (GBS III-TT) Vaccine', 'III-TT conjugate or tetanus diphtheria toxoid vaccine', 'GBS type III capsular polysaccharide (CPS)-tetanus toxoid conjugate (III-TT) vaccine', 'GBS CPS III-TT conjugate vaccine', 'Group B Streptococcus (GBS']","['first rectal acquisition efficacy', 'geometric mean concentrations of serum GBS type III CPS-specific immunoglobulin G', 'safety and efficacy', 'tolerated', 'delayed acquisition of vaginal and rectal GBS III colonization', 'vaginal GBS III, vaccine efficacy', 'GBS vaginal and rectal cultures and blood', 'Vaginal Colonization', 'Serum concentrations of GBS III CPS-specific antibodies']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1305399', 'cui_str': 'Screening intent'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C4521343', 'cui_str': 'Vaginal (intended site)'}, {'cui': 'C0205052', 'cui_str': 'Rectal (qualifier value)'}, {'cui': 'C0855652', 'cui_str': 'Culture negative'}, {'cui': 'C3844101', 'cui_str': '650'}, {'cui': 'C1283828', 'cui_str': 'Intentional'}, {'cui': 'C1292734', 'cui_str': 'Treats'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C0332239', 'cui_str': 'Young (qualifier value)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}]","[{'cui': 'C0441731', 'cui_str': 'Type 3 (qualifier value)'}, {'cui': 'C0205151', 'cui_str': 'Capsular (qualifier value)'}, {'cui': 'C0032594', 'cui_str': 'Glycans'}, {'cui': 'C0305062', 'cui_str': 'Clostridium tetani toxoid antigen, inactivated'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0301869', 'cui_str': 'Conjugate'}, {'cui': 'C0012551', 'cui_str': 'diphtheria toxoid vaccine, inactivated'}, {'cui': 'C0206515', 'cui_str': 'Vaccines, Conjugate'}, {'cui': 'C0579233', 'cui_str': 'Streptococcus agalactiae'}]","[{'cui': 'C0205052', 'cui_str': 'Rectal (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0441731', 'cui_str': 'Type 3 (qualifier value)'}, {'cui': 'C0358334', 'cui_str': 'Specific immunoglobulins'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C4521343', 'cui_str': 'Vaginal (intended site)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0220814', 'cui_str': 'culture'}, {'cui': 'C0005768'}, {'cui': 'C0443640', 'cui_str': 'Specific antibody (substance)'}]",650.0,0.0632893,"Two months post-immunization, geometric mean concentrations of serum GBS type III CPS-specific immunoglobulin G were 12.6 µg/mL (95% CI, 9.95 to 15.81) in GBS III-TT recipients, representing a 4-fold increase from baseline in 95% of women, which persisted.","[{'ForeName': 'Sharon L', 'Initials': 'SL', 'LastName': 'Hillier', 'Affiliation': 'University of Pittsburgh School of Medicine, Magee-Womens Hospital, Pennsylvania.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Ferrieri', 'Affiliation': 'Department of Laboratory Medicine and Pathology and Pediatrics, University of Minnesota Medical School, Minneapolis.'}, {'ForeName': 'Morven S', 'Initials': 'MS', 'LastName': 'Edwards', 'Affiliation': 'Baylor College of Medicine, Department of Pediatrics, Feigin Center, Houston, Texas.'}, {'ForeName': 'Marian', 'Initials': 'M', 'LastName': 'Ewell', 'Affiliation': 'The EMMES Corporation, Rockville, Maryland.'}, {'ForeName': 'Daron', 'Initials': 'D', 'LastName': 'Ferris', 'Affiliation': 'Medical College of Georgia, Augusta.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Fine', 'Affiliation': 'Planned Parenthood Gulf Coast, Houston, Texas.'}, {'ForeName': 'Vincent', 'Initials': 'V', 'LastName': 'Carey', 'Affiliation': ""Channing Division of Network Medicine, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Leslie', 'Initials': 'L', 'LastName': 'Meyn', 'Affiliation': 'University of Pittsburgh School of Medicine, Magee-Womens Hospital, Pennsylvania.'}, {'ForeName': 'Dakota', 'Initials': 'D', 'LastName': 'Hoagland', 'Affiliation': 'COTA Enterprises, McLouth, Kansas.'}, {'ForeName': 'Dennis L', 'Initials': 'DL', 'LastName': 'Kasper', 'Affiliation': 'Division of Immunology, Department of Microbiology and Immunobiology, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Lawrence C', 'Initials': 'LC', 'LastName': 'Paoletti', 'Affiliation': 'Division of Immunology, Department of Microbiology and Immunobiology, Harvard Medical School, Boston, Massachusetts.'}, {'ForeName': 'Heather', 'Initials': 'H', 'LastName': 'Hill', 'Affiliation': 'The EMMES Corporation, Rockville, Maryland.'}, {'ForeName': 'Carol J', 'Initials': 'CJ', 'LastName': 'Baker', 'Affiliation': 'Divsion of Infectious Disease, Department of Pediatrics, University of Texas Health Science Center McGovern Medical School, Houston.'}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciy838'] 3263,32026827,Development and implementation of the physiotherapy-led exercise interventions for the treatment of rotator cuff disorders for the 'Getting it Right: Addressing Shoulder Pain' (GRASP) trial.,"OBJECTIVES The Getting it Right: Addressing Shoulder Pain (GRASP) trial is a large-scale, multicentre, 2×2 factorial randomised controlled trial investigating clinical and cost-effectiveness of a progressive exercise programme versus best-practice advice, with or without corticosteroid injection, for treating people with rotator cuff disorders. Here we describe the development, implementation and details of the physiotherapy-led interventions. METHODS Medical Research Council guidance for developing complex interventions were used, taking into account clinical guidelines, expert and patient opinion, research evidence, current practice variation, and deliverability. A stakeholder meeting of 26 experts, clinicians, researchers, and patient representatives was used to design key components of the interventions. Stakeholders prioritised strengthening posterior rotator cuff muscles and using practical, easy-to-do exercises. The interventions were designed to be deliverable across the UK National Health Service. RESULTS Progressive exercise consists of up to six sessions with a physiotherapist over 16 weeks. The best-practice advice consists of one face-to-face session with a physiotherapist with substantially greater reliance on self-management. Both interventions include self-management advice, home-exercise instruction, and behaviour-change strategies to target exercise adherence. All participants receive a Participant Information Booklet. The best-practice advice intervention is a self-guided system of progressively challenging exercises, with demonstration videos and written materials. The progressive exercise intervention has a wider range of exercise options, and greater flexibility for tailoring, progression, supervised practice and feedback. CONCLUSION GRASP has recruited 708 participants and will provide high quality evidence to inform management of people with shoulder pain due to a rotator cuff disorder. Results are anticipated in 2020. TRIAL REGISTRATION NUMBER ISRCTN16539266; EudraCT number:2016-002991-28.",2020,"The progressive exercise intervention has a wider range of exercise options, and greater flexibility for tailoring, progression, supervised practice and feedback. ","['people with rotator cuff disorders', 'Right']","['progressive exercise intervention', 'progressive exercise programme versus best-practice advice, with or without corticosteroid injection', 'physiotherapy-led exercise interventions']",[],"[{'cui': 'C0085515', 'cui_str': 'Rotator Cuff'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0205090', 'cui_str': 'Right (qualifier value)'}]","[{'cui': 'C0205329', 'cui_str': 'Progressive (qualifier value)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C3179154', 'cui_str': 'Best Practices'}, {'cui': 'C3539185', 'cui_str': 'Corticosteroid nasal preparations for topical use'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0699718', 'cui_str': 'Physiotherapy (qualifier value)'}, {'cui': 'C0023175', 'cui_str': 'Lead'}]",[],,0.0901959,"The progressive exercise intervention has a wider range of exercise options, and greater flexibility for tailoring, progression, supervised practice and feedback. ","[{'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Keene', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK. Electronic address: david.keene@ndorms.ox.ac.uk.'}, {'ForeName': 'Hessam', 'Initials': 'H', 'LastName': 'Soutakbar', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Sally', 'Initials': 'S', 'LastName': 'Hopewell', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Heine', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Anju', 'Initials': 'A', 'LastName': 'Jaggi', 'Affiliation': 'Royal National Orthopaedic Hospital NHS Trust, Stanmore, Middlesex, UK.'}, {'ForeName': 'Chris', 'Initials': 'C', 'LastName': 'Littlewood', 'Affiliation': 'Primary Care and Health Sciences, Keele University, Keele, UK.'}, {'ForeName': 'Zara', 'Initials': 'Z', 'LastName': 'Hansen', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Barker', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK; Oxford University Hospitals NHS Foundation Trust, Oxford, UK.'}, {'ForeName': 'Willie', 'Initials': 'W', 'LastName': 'Hamilton', 'Affiliation': 'Institute of Health Research, University of Exeter, Exeter, UK.'}, {'ForeName': 'Andrew J', 'Initials': 'AJ', 'LastName': 'Carr', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Sarah E', 'Initials': 'SE', 'LastName': 'Lamb', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK.'}]",Physiotherapy,['10.1016/j.physio.2019.07.002'] 3264,32008847,Routine exercise-based cardiac rehabilitation does not increase aerobic fitness: A CARE CR study.,"BACKGROUND Recent evidence suggests that routine exercise-based cardiac rehabilitation (CR) may not lead to a substantial increase in estimated peak oxygen uptake (V̇O 2peak ). This could reduce the potential benefits of CR and explain why CR no longer improves patient survival in recent studies. We aimed to determine whether routine exercise-based CR increases V̇O 2peak using gold-standard maximal cardiopulmonary exercise testing (CPET), and to quantify the exercise training stimulus which might be insufficient in patients undertaking CR. METHODS We studied the effects of a routine, twice weekly, exercise-based CR programme for eight weeks (intervention group) compared with abstention from supervised exercise training (control group) in patients with coronary heart disease. The primary outcome was V̇O 2peak measured using CPET. We also measured changes in body composition using dual X-ray absorptiometry, carotid intima-media thickness, hs-CRP and N-terminal pro B-type natriuretic peptide at baseline, 10 weeks and 12 months. We also calculated the Calibre 5-year all-cause mortality risk score. RESULTS Seventy patients (age 63.1 SD10.0 years; BMI 29.2 SD4.0 kg·m -2 ; 86% male) were recruited (n = 48 intervention; n = 22 controls). The mean aerobic exercise training duration was 23 min per training session, and the mean exercise training intensity was 45.9% of heart rate reserve. V̇O 2peak was 23·3 ml·kg -1 ·min -1 at baseline, and there were no changes in V̇O 2peak between groups at any time point. The intervention had no effect on any of the secondary endpoints. CONCLUSION Routine CR does not lead to an increase in V̇O 2peak and is unlikely to improve long-term physiological outcomes.",2020,"CONCLUSION Routine CR does not lead to an increase in V̇O 2peak and is unlikely to improve long-term physiological outcomes.","['patients undertaking CR', 'patients with coronary heart disease', 'Seventy patients (age 63.1 SD10.0\xa0years']","['exercise-based CR programme for eight weeks (intervention group) compared with abstention from supervised exercise training (control group', 'routine exercise-based CR increases V̇O 2peak using gold-standard maximal cardiopulmonary exercise testing (CPET', 'Routine exercise-based cardiac rehabilitation', 'routine exercise-based cardiac rehabilitation (CR']","['body composition using dual X-ray absorptiometry, carotid intima-media thickness, hs-CRP and N-terminal pro B-type natriuretic peptide', 'V̇O 2peak', 'mean aerobic exercise training duration', 'V̇O 2peak measured using CPET', 'aerobic fitness', 'patient survival', 'mean exercise training intensity', 'Calibre 5-year all-cause mortality risk score']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0041666', 'cui_str': 'Undertaking'}, {'cui': 'C0010068', 'cui_str': 'Coronary Disease'}, {'cui': 'C3816957', 'cui_str': '70'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0205547', 'cui_str': 'Routine (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0018026', 'cui_str': 'Gold'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0055954', 'cui_str': 'CPET'}, {'cui': 'C0700431', 'cui_str': 'Cardiovascular Rehabilitation'}]","[{'cui': 'C0005885', 'cui_str': 'Body Composition'}, {'cui': 'C1510486', 'cui_str': 'Dual X-Ray Absorptiometry'}, {'cui': 'C0162864', 'cui_str': 'Vascular Intima'}, {'cui': 'C0754710', 'cui_str': 'Amino-terminal pro-brain natriuretic peptide'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001701', 'cui_str': 'Exercise, Aerobic'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0055954', 'cui_str': 'CPET'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C4279936', 'cui_str': 'Exercise Training'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C1301886', 'cui_str': 'Diameter (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0678227', 'cui_str': 'Causing (attribute)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",86.0,0.153767,"CONCLUSION Routine CR does not lead to an increase in V̇O 2peak and is unlikely to improve long-term physiological outcomes.","[{'ForeName': 'S', 'Initials': 'S', 'LastName': 'Nichols', 'Affiliation': 'Centre for Sports and Exercise Science, Sheffield Hallam University, Collegiate Campus, Sheffield S10 2BP, United Kingdom. Electronic address: s.j.nichols@shu.ac.uk.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Taylor', 'Affiliation': 'Department of Sport, Health and Exercise Science, Don Building, University of Hull Cottingham Road Hull, HU6 7RX, United Kingdom. Electronic address: claire@hewison.net.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Goodman', 'Affiliation': 'City Health Care Partnership CIC, East Riding Community Hospital, Swinemoore Lane, Beverley HU17 0FA, United Kingdom. Electronic address: toni.goodman@nhs.net.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Page', 'Affiliation': 'Department of Sport, Health and Exercise Science, Don Building, University of Hull Cottingham Road Hull, HU6 7RX, United Kingdom. Electronic address: r.page@hull.ac.uk.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Kallvikbacka-Bennett', 'Affiliation': 'Academic Cardiology Castle Hill Hospital, Hull and East Yorkshire Hospitals, Castle Road, Cottingham HU16 5JQ, United Kingdom. Electronic address: Anna.Bennett@hey.nhs.uk.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Nation', 'Affiliation': 'Department of Sport, Health and Exercise Science, Don Building, University of Hull Cottingham Road Hull, HU6 7RX, United Kingdom. Electronic address: f.nation@hull.ac.uk.'}, {'ForeName': 'A L', 'Initials': 'AL', 'LastName': 'Clark', 'Affiliation': 'Academic Cardiology Castle Hill Hospital, Hull and East Yorkshire Hospitals, Castle Road, Cottingham HU16 5JQ, United Kingdom. Electronic address: A.L.Clark@hull.ac.uk.'}, {'ForeName': 'S T', 'Initials': 'ST', 'LastName': 'Birkett', 'Affiliation': 'School of Sport and Health Sciences, University of Central Lancashire, Preston, PR1 2HE, United Kingdom. Electronic address: SBirkett4@uclan.ac.uk.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Carroll', 'Affiliation': 'Department of Sport, Health and Exercise Science, Don Building, University of Hull Cottingham Road Hull, HU6 7RX, United Kingdom. Electronic address: s.carroll@hull.ac.uk.'}, {'ForeName': 'L', 'Initials': 'L', 'LastName': 'Ingle', 'Affiliation': 'Department of Sport, Health and Exercise Science, Don Building, University of Hull Cottingham Road Hull, HU6 7RX, United Kingdom. Electronic address: l.ingle@hull.ac.uk.'}]",International journal of cardiology,['10.1016/j.ijcard.2020.01.044'] 3265,32068914,"Effects of the dual sodium-glucose linked transporter inhibitor, licogliflozin vs placebo or empagliflozin in patients with type 2 diabetes and heart failure.","AIMS Explore the efficacy, safety and tolerability of the dual sodium-glucose cotransporter (SGLT) 1 and 2 inhibitor, licogliflozin in patients with type-2 diabetes mellitus (T2DM) and heart failure. METHODS This multicentre, parallel-group phase IIA study randomized 125 patients with T2DM and heart failure (New York Heart Association II-IV; plasma N-terminal pro b-type natriuretic peptide [NT-proBNP] >300 pg/mL) to licogliflozin (2.5 mg, 10 mg, 50 mg) taken at bedtime, empagliflozin (25 mg) or placebo (44 patients completed the study). The primary endpoint was change from baseline in NT-proBNP after 12 weeks. Secondary endpoints included change from baseline in glycated haemoglobin, fasting plasma glucose, weight, blood pressure, fasting lipid profile, high-sensitivity c-reactive protein, and safety and tolerability. RESULTS Licogliflozin 10 mg for 12 weeks significantly reduced NT-proBNP vs placebo (Geometric mean ratio 0.56 [95% confidence interval: 0.33, 0.95], P = .033). A trend was observed with 50 mg licogliflozin (0.64 [95% confidence interval: 0.40, 1.03], P = .064), with no difference between licogliflozin and empagliflozin. The largest numerical decreases in glycated haemoglobin were with licogliflozin 50 mg (-0.58 ± 0.34%) and empagliflozin (-0.44 ± 1.18%) vs placebo (-0.04 ± 0.91%). The reduction in body weight was similar with licogliflozin 50 mg (-2.15 ± 2.40 kg) and empagliflozin (-2.25 ± 1.89 kg). A numerical reduction in systolic blood pressure was seen with licogliflozin 50 mg (-9.54 ± 16.88 mmHg) and empagliflozin (-6.98 ± 15.03 mmHg) vs placebo (-2.85 ± 11.97 mmHg). Adverse events (AEs) were mild, including hypotension (6.5%), hypoglycaemia (8.1%) and inadequate diabetes control (1.6%). The incidence of diarrhoea (4.9%) was lower than previously reported. CONCLUSION The reduction in NT-proBNP with licogliflozin suggests a potential benefit of SGLT1 and 2 inhibition in patients with T2DM and heart failure.",2020,"RESULTS Licogliflozin 10 mg for 12 weeks significantly reduced NT-proBNP vs. placebo (Geometric mean ratio 0.56 [95% CI: 0.33, 0.95], p=0.033).","['patients with type 2 diabetes and heart failure', 'patients with type-2 diabetes mellitus (T2DM) and heart failure', 'patients with T2DM and heart failure', '44 patients completed the study', '125 patients with T2DM and heart failure (NYHA II-IV; plasma NT-proBNP >300 pg/mL) to']","['placebo', 'Licogliflozin', 'empagliflozin', 'licogliflozin and empagliflozin', 'licogliflozin', 'dual sodium glucose co-transporter (SGLT) 1 and 2 inhibitor, licogliflozin', 'dual sodium-glucose linked transporter inhibitor, licogliflozin versus placebo or empagliflozin']","['inadequate diabetes control', 'NT-proBNP', 'body weight', 'change from baseline in NT-proBNP', 'systolic BP', 'efficacy, safety and tolerability', 'change from baseline in glycated hemoglobin (HbA1c), fasting plasma glucose, weight, blood pressure (BP), fasting lipid profile, high-sensitivity c-reactive protein, and safety and tolerability', 'Adverse events (AEs) were mild, including hypotension', 'hypoglycemia', 'incidence of diarrhea']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C4319551', 'cui_str': 'One hundred and twenty-five'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C1963813', 'cui_str': 'NT-proBNP'}, {'cui': 'C4319604', 'cui_str': '300'}, {'cui': 'C0439297', 'cui_str': 'pg/mL'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C3490348', 'cui_str': 'empagliflozin'}, {'cui': 'C3541959', 'cui_str': 'Sodium supplement (substance)'}, {'cui': 'C0337438', 'cui_str': 'Glucose measurement (procedure)'}, {'cui': 'C0598849', 'cui_str': 'Co-Transporters'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C3854146', 'cui_str': 'Transporter (physical object)'}]","[{'cui': 'C0205412', 'cui_str': 'Inadequate (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C1963813', 'cui_str': 'NT-proBNP'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0019046', 'cui_str': 'Hemoglobin'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma (procedure)'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C0430044', 'cui_str': 'Fasting lipid profile (procedure)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0020649', 'cui_str': 'Blood Pressure, Low'}, {'cui': 'C4087542', 'cui_str': 'Hypoglycaemia (SMQ)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}]",125.0,0.391465,"RESULTS Licogliflozin 10 mg for 12 weeks significantly reduced NT-proBNP vs. placebo (Geometric mean ratio 0.56 [95% CI: 0.33, 0.95], p=0.033).","[{'ForeName': 'Rudolf A', 'Initials': 'RA', 'LastName': 'de Boer', 'Affiliation': 'University of Groningen, University Medical Centre Groningen, Groningen, The Netherlands.'}, {'ForeName': 'Julio', 'Initials': 'J', 'LastName': 'Núñez', 'Affiliation': 'Servicio de Cardiología, Hospital Clínico Universitario Valencia, València, Spain.'}, {'ForeName': 'Plamen', 'Initials': 'P', 'LastName': 'Kozlovski', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Yi', 'Initials': 'Y', 'LastName': 'Wang', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.'}, {'ForeName': 'Pieter', 'Initials': 'P', 'LastName': 'Proot', 'Affiliation': 'Novartis Pharma AG, Basel, Switzerland.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Keefe', 'Affiliation': 'Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.'}]",British journal of clinical pharmacology,['10.1111/bcp.14248'] 3266,32072735,Dapagliflozin plus saxagliptin add-on to metformin reduces liver fat and adipose tissue volume in patients with type 2 diabetes.,"AIM To assess the effects of dapagliflozin plus saxagliptin plus metformin versus glimepiride plus metformin on liver fat (proton density fat fraction) and visceral and subcutaneous adipose tissue volumes over 52 weeks of treatment. MATERIALS AND METHODS This was a magnetic resonance imaging substudy of a 52-week, multicentre, randomized, double-blind, parallel-group trial that evaluated the efficacy and safety of dapagliflozin 10 mg/day plus saxagliptin 5 mg/day versus titrated glimepiride 1-6 mg (1, 2, 3, 4 or 6 mg) in 82 patients with type 2 diabetes (HbA1c 7.5%-10.5%) on metformin ≥1500 mg/day background. Analyses were exploratory and not controlled for multiplicity; P-values are nominal. RESULTS Magnetic resonance imaging was performed on 59 patients; liver fat and adipose tissue volumes were analysed for 59 and 57 patients, respectively. There was a significant >30% reduction from baseline in liver fat (P = 0.007) and >10% reduction in adipose tissue volumes (P < 0.01) with dapagliflozin plus saxagliptin plus metformin at week 52 versus glimepiride plus metformin. In the full-study population, dapagliflozin plus saxagliptin plus metformin decreased body weight and serum alanine aminotransferase and aspartate aminotransferase levels over 52 weeks. CONCLUSIONS Dapagliflozin plus saxagliptin significantly decreased liver fat and adipose tissue volume versus glimepiride, and reduced serum liver enzyme levels, indicating a favourable metabolic profile of dapagliflozin plus saxagliptin in patients with type 2 diabetes on metformin therapy.",2020,There was a significant >30% reduction from baseline in liver fat (P=0.007) and >10% reduction in adipose tissue volumes (P<0.01) with dapagliflozin plus saxagliptin plus metformin at week 52 versus glimepiride plus metformin.,"['adult patients with type 2 diabetes (T2D', 'patients with T2D on metformin therapy', 'patients with type 2 diabetes', '82 patients with T2D (HbA1c 7.5%-10.5%) on']","['metformin', 'metformin ≥1,500 mg/day background', 'sodium-glucose cotransporter-2 inhibitor dapagliflozin and the dipeptidyl peptidase-4 inhibitor saxagliptin', 'dapagliflozin 10 mg/day plus saxagliptin', 'Magnetic resonance imaging (MRI', 'glimepiride plus metformin', 'glimepiride', 'dapagliflozin plus saxagliptin plus metformin', 'Dapagliflozin plus saxagliptin', 'dapagliflozin plus saxagliptin']","['adipose tissue volumes', 'body weight and serum alanine aminotransferase and aspartate aminotransferase levels', 'efficacy and safety', 'liver fat (proton density fat fraction [PDFF]) and visceral and subcutaneous adipose tissue volumes', 'liver fat and adipose tissue volumes', 'liver fat', 'serum liver enzyme levels', 'liver fat and adipose tissue volume']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0202054', 'cui_str': 'HbA1C'}, {'cui': 'C4517859', 'cui_str': 'Seven point five'}, {'cui': 'C4517521', 'cui_str': '10.5'}]","[{'cui': 'C0025598', 'cui_str': 'Metformin'}, {'cui': 'C0439422', 'cui_str': 'mg/day'}, {'cui': 'C0017739', 'cui_str': 'Sodium-Glucose Transport Proteins'}, {'cui': 'C0243077', 'cui_str': 'inhibitors'}, {'cui': 'C2353951', 'cui_str': 'dapagliflozin'}, {'cui': 'C1827106', 'cui_str': 'Dipeptidyl-Peptidase 4 Inhibitors'}, {'cui': 'C1611934', 'cui_str': 'saxagliptin'}, {'cui': 'C3709918', 'cui_str': 'dapagliflozin 10 MG'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C1552358', 'cui_str': 'Magnetic resonance imaging'}, {'cui': 'C0024485', 'cui_str': 'Steady-State Free Precession MRI'}, {'cui': 'C0061323', 'cui_str': 'glimepiride'}]","[{'cui': 'C0001527', 'cui_str': 'Fatty Tissue'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0005910', 'cui_str': 'Body Weight'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0201836', 'cui_str': 'Alanine aminotransferase measurement (procedure)'}, {'cui': 'C0428339', 'cui_str': 'Aspartate transaminase level (finding)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0023884', 'cui_str': 'Liver'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C0033727', 'cui_str': 'Hydrogen Ions'}, {'cui': 'C0178587', 'cui_str': 'Mass to volume ratio'}, {'cui': 'C1264633', 'cui_str': 'Fractions of (qualifier value)'}, {'cui': 'C0442045', 'cui_str': 'Visceral (qualifier value)'}, {'cui': 'C0222331', 'cui_str': 'Subcutaneous Fat'}, {'cui': 'C1287351', 'cui_str': 'Finding of liver enzyme levels (finding)'}]",82.0,0.0592902,There was a significant >30% reduction from baseline in liver fat (P=0.007) and >10% reduction in adipose tissue volumes (P<0.01) with dapagliflozin plus saxagliptin plus metformin at week 52 versus glimepiride plus metformin.,"[{'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Johansson', 'Affiliation': 'Antaros Medical AB, BioVenture Hub, Mölndal, Sweden.'}, {'ForeName': 'Paul D', 'Initials': 'PD', 'LastName': 'Hockings', 'Affiliation': 'Antaros Medical AB, BioVenture Hub, Mölndal, Sweden.'}, {'ForeName': 'Eva', 'Initials': 'E', 'LastName': 'Johnsson', 'Affiliation': 'Global Medicines Development, AstraZeneca, Gothenburg, Sweden.'}, {'ForeName': 'Nalina', 'Initials': 'N', 'LastName': 'Dronamraju', 'Affiliation': 'Global Medicines Development, AstraZeneca, Gaithersburg, Maryland, United States.'}, {'ForeName': 'Jill', 'Initials': 'J', 'LastName': 'Maaske', 'Affiliation': 'Global Medicines Development, AstraZeneca, Gaithersburg, Maryland, United States.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Garcia-Sanchez', 'Affiliation': 'Global Medicines Development, AstraZeneca, Gaithersburg, Maryland, United States.'}, {'ForeName': 'John P H', 'Initials': 'JPH', 'LastName': 'Wilding', 'Affiliation': 'Obesity and Endocrinology Research Group, Institute of Ageing and Chronic Disease, University of Liverpool, Liverpool, United Kingdom.'}]","Diabetes, obesity & metabolism",['10.1111/dom.14004'] 3267,30389590,What is the best position to place and re-evaluate an unconscious but normally breathing victim? A randomised controlled human simulation trial on children.,"BACKGROUND Current resuscitation guidelines endorse placing the unconscious and normally breathing victims in the recovery position (RP), but this technique might hinder breathing evaluation. AIM To compare breathing evaluation and cardiac arrest detection: placing the victim in RP and checking breathing regularly, placing the victim in RP while re-evaluating breathing every minute, and placing the victim on his back, maintaining an open airway with the head-tilt-chin-lift technique and continuously checking breathing. METHODS Schoolchildren aged 10-12 with no previous cardiopulmonary resuscitation (CPR) training, from three different primary schools were randomly allocated into groups to receive a CPR course involving one of the three strategies. Then a human simulation took place. RESULT 192 schoolchildren (64 per group) were randomly selected and received one of the courses. 182 participants who correctly assessed the victim were compared: 16 (26.2%) out of the 59 participants using RP and checking breathing regularly detected cardiac arrest before the end of the simulation, compared to 41 (67.20%) out of 61 using RP re-evaluating breathing every minute, and 56 (90.3%) out of 62 using head-tilt-chin-lift. Statistically significant differences were found between the RP groups (p < 0.001; OR = 5.766) as well as between the Head-tilt-chin-lift and both RP groups (p < 0.001; OR = 21.094), (p = 0.002; OR = 4.553). CONCLUSION The strategy involving head-tilt-chin-lift significantly increased the likelihood of detecting cardiac arrest. Re-evaluating every minute when the RP was used significantly increased the likelihood of detecting cardiac arrest.",2019,"Statistically significant differences were found between the RP groups (p < 0.001; OR = 5.766) as well as between the Head-tilt-chin-lift and both RP groups (p < 0.001; OR = 21.094), (p = 0.002; OR = 4.553). ","['children', 'Schoolchildren aged 10-12 with no previous cardiopulmonary resuscitation (CPR) training, from three different primary schools', '182 participants who correctly assessed the victim were compared: 16 (26.2%) out of the 59 participants using', '192 schoolchildren (64 per group']",[],"['likelihood of detecting cardiac arrest', 'RP and checking breathing regularly detected cardiac arrest']","[{'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205156', 'cui_str': 'Previous (qualifier value)'}, {'cui': 'C0007203', 'cui_str': 'Cardio-Pulmonary Resuscitation'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0033145', 'cui_str': 'Primary Schools'}, {'cui': 'C4517623', 'cui_str': '192'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]",[],"[{'cui': 'C0442726', 'cui_str': 'Detected (qualifier value)'}, {'cui': 'C0018790', 'cui_str': 'Cardiac Arrest'}, {'cui': 'C0035203', 'cui_str': 'Breathing'}]",192.0,0.0133898,"Statistically significant differences were found between the RP groups (p < 0.001; OR = 5.766) as well as between the Head-tilt-chin-lift and both RP groups (p < 0.001; OR = 21.094), (p = 0.002; OR = 4.553). ","[{'ForeName': 'Rubén', 'Initials': 'R', 'LastName': 'Navarro-Patón', 'Affiliation': 'University of Santiago de Compostela, Faculty of Teacher Training, Avda. Ramón Ferreiro sn, C.P. 27001, Lugo, Spain. Electronic address: ruben.navarro.paton@usc.es.'}, {'ForeName': 'Miguel', 'Initials': 'M', 'LastName': 'Freire-Tellado', 'Affiliation': 'Emergency Medical Service, Base 061 Lugo, Centro de Salud de Fingoy, calle, Armórica sn, 27002, Lugo, Spain. Electronic address: miguel.freire.tellado@sergas.es.'}, {'ForeName': 'Noel', 'Initials': 'N', 'LastName': 'Fernández-González', 'Affiliation': 'University of Santiago de Compostela, Faculty of Teacher Training, Avda. Ramón Ferreiro sn, C.P. 27001, Lugo, Spain. Electronic address: noel.fernandez@rai.usc.es.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Basanta-Camiño', 'Affiliation': 'University of Santiago de Compostela, Faculty of Teacher Training, Avda. Ramón Ferreiro sn, C.P. 27001, Lugo, Spain. Electronic address: s.basanta@usc.es.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Mateos-Lorenzo', 'Affiliation': 'Emergency Medical Services, Division of Nursing, Cantabria, Spain. Electronic address: javier.mateos@scsalud.es.'}, {'ForeName': 'Joaquín', 'Initials': 'J', 'LastName': 'Lago-Ballesteros', 'Affiliation': 'University of Santiago de Compostela, Faculty of Teacher Training, Avda. Ramón Ferreiro sn, C.P. 27001, Lugo, Spain. Electronic address: joaquin.lago@usc.es.'}]",Resuscitation,['10.1016/j.resuscitation.2018.10.030'] 3268,31500466,Proresolving mediator profiles in cerebrospinal fluid are linked with disease severity and outcome in adults with tuberculous meningitis.,"Tuberculous meningitis (TBM) is the most lethal form of tuberculosis infection, characterized by a dysregulated immune response that frequently leads to neurologic injury and death despite the best available treatment. The mechanisms driving the inflammatory response in TBM are not well understood. To gain insights into these mechanisms, we used a lipid mediator-profiling approach to investigate the regulation of a novel group of host protective mediators, termed specialized proresolving mediators (SPMs), in the cerebrospinal fluid (CSF) of adults with TBM. Herein, using CSF from patients enrolled into a randomized placebo-controlled trial of adjunctive aspirin treatment, we found distinct lipid mediator profiles with increasing disease severity. These changes were linked with an up-regulation of inflammatory eicosanoids in patients with severe TBM and a decrease in the production of a number of SPMs. CSF proresolving mediator concentrations were also associated with 80-d survival. In survivors, we found a significant increase in proresolving mediator concentrations, including the lipoxygenase 5-derived 13-series resolvin (RvT)2, RvT4, and 15-epi-lipoxin B 4 , compared with those who died. Of note, treatment of patients with high-dose aspirin led to a decrease in the concentrations of the prothrombic mediator thromboxane A 2 , reduced brain infarcts, and decreased death in patients with TBM. Together, these findings identify a CSF SPM signature that is associated with disease severity and 80-d mortality in TBM.-Colas, R. A., Nhat, L. T. H., Thuong, N. T. T., Gómez, E. A., Ly, L., Thanh, H. H., Mai, N. T. H., Phu, N. H., Thwaites, G. E., Dalli, J. Proresolving mediator profiles in cerebrospinal fluid are linked with disease severity and outcome in adults with tuberculous meningitis.",2019,These changes were linked with an up-regulation of inflammatory eicosanoids in patients with severe TBM and a decrease in the production of a number of SPMs.,"['patients with TBM', 'patients with high-dose', 'adults with tuberculous meningitis', 'adults with TBM']","['placebo', 'adjunctive aspirin', 'aspirin']","['proresolving mediator concentrations', 'lipoxygenase 5-derived 13-series resolvin (RvT)2, RvT4, and 15-epi-lipoxin B 4', 'CSF proresolving mediator concentrations', 'concentrations of the prothrombic mediator thromboxane A 2 , reduced brain infarcts']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0041318', 'cui_str': 'Tubercular Meningitis'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0004057', 'cui_str': 'acetylsalicylic acid'}]","[{'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C2936592', 'cui_str': 'Lipoxygenases'}, {'cui': 'C0205549', 'cui_str': 'Series (qualifier value)'}, {'cui': 'C0267963', 'cui_str': 'Pancreatic Insufficiency'}, {'cui': 'C0599689', 'cui_str': 'Lipoxins'}, {'cui': 'C0040061', 'cui_str': 'Thromboxanes'}, {'cui': 'C0392756', 'cui_str': 'Reduced (qualifier value)'}, {'cui': 'C0006104', 'cui_str': 'Encephalon'}, {'cui': 'C0021308', 'cui_str': 'Infarction'}]",,0.0530299,These changes were linked with an up-regulation of inflammatory eicosanoids in patients with severe TBM and a decrease in the production of a number of SPMs.,"[{'ForeName': 'Romain A', 'Initials': 'RA', 'LastName': 'Colas', 'Affiliation': 'William Harvey Research Institute, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, United Kingdom.'}, {'ForeName': 'Le Thanh Hoang', 'Initials': 'LTH', 'LastName': 'Nhat', 'Affiliation': 'Oxford University Clinical Research Unit, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Nguyen Thuy Thuong', 'Initials': 'NTT', 'LastName': 'Thuong', 'Affiliation': 'Oxford University Clinical Research Unit, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Esteban A', 'Initials': 'EA', 'LastName': 'Gómez', 'Affiliation': 'William Harvey Research Institute, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, United Kingdom.'}, {'ForeName': 'Lucy', 'Initials': 'L', 'LastName': 'Ly', 'Affiliation': 'William Harvey Research Institute, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, United Kingdom.'}, {'ForeName': 'Hai Hoang', 'Initials': 'HH', 'LastName': 'Thanh', 'Affiliation': 'Oxford University Clinical Research Unit, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Nguyen Thi Hoang', 'Initials': 'NTH', 'LastName': 'Mai', 'Affiliation': 'Oxford University Clinical Research Unit, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Nguyen Hoan', 'Initials': 'NH', 'LastName': 'Phu', 'Affiliation': 'Oxford University Clinical Research Unit, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Guy E', 'Initials': 'GE', 'LastName': 'Thwaites', 'Affiliation': 'Oxford University Clinical Research Unit, Ho Chi Minh City, Vietnam.'}, {'ForeName': 'Jesmond', 'Initials': 'J', 'LastName': 'Dalli', 'Affiliation': 'William Harvey Research Institute, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, United Kingdom.'}]",FASEB journal : official publication of the Federation of American Societies for Experimental Biology,['10.1096/fj.201901590R'] 3269,31240870,Effectiveness of high-frequency left prefrontal repetitive transcranial magnetic stimulation in patients with treatment-resistant depression: A randomized clinical trial of 37.5-minute vs 18.75-minute protocol.,"AIM Clinical trials and meta-analyses have demonstrated the efficacy of high-frequency repetitive transcranial magnetic stimulation (rTMS) over the left prefrontal cortex in treatment-resistant depression. The aim of this study was to prospectively evaluate the effectiveness of the conventional 37.5-minute vs 18.75-minute rTMS protocol over the left prefrontal cortex in patients with treatment-resistant depressive episode. METHODS Thirty patients with treatment-resistant depression or bipolar disorder depressive episode were randomized 1:1 to either 37.5-minute or 18.75-minute rTMS protocol groups. rTMS treatment was applied at 120% resting motor threshold with 10 Hz over the left prefrontal cortex. Treatment sessions were delivered for a total of 3000 pulses/d, 5 days a week, for 4-6 weeks. Patients received a 75 trains with ""4 sec on and 26 sec off"" for 37.5 minutes or a 75 trains with ""4 sec on and 11 sec off"" for 18.75 minutes. Severity of depression was rated with the Quick Inventory of Depressive Symptomatology (QIDS) and Patient Health Questionnaire (PHQ-9). Remission was defined as a total score of 5 or less on the QIDS. The primary outcome measure was to compare the remission rate between the both groups. RESULTS Thirteen of 30 patients (43.3%) showed remission at week 6. There were no significant differences in the remission rate between the conventional 37.5- and 18.75-minute protocol groups (46.7% and 40.0%, respectively). No seizures or treatment-emergent mania/hypomania were occurred. CONCLUSION These findings suggest that, compared with the conventional one, rTMS with 18.75-minute protocol might be equally effective and clinically beneficial in saving the treatment session length. Further well-designed studies are needed.",2019,"There were no significant differences in the remission rate between the conventional 37.5- and 18.75-minute protocol groups (46.7% and 40.0%, respectively).","['Thirty patients with treatment-resistant depression or bipolar disorder depressive episode', 'patients with treatment-resistant depressive episode', 'patients with treatment-resistant depression']","['high-frequency left prefrontal repetitive transcranial magnetic stimulation', 'high-frequency repetitive transcranial magnetic stimulation (rTMS', 'conventional 37.5-minute vs 18.75-minute rTMS protocol', '75 trains with ""4\xa0sec on and 26\xa0sec off"" for 37.5\xa0minutes or a 75 trains with ""4\xa0sec on and 11\xa0sec off"" for 18.75\xa0minutes', 'rTMS']","['remission rate', 'Quick Inventory of Depressive Symptomatology (QIDS) and Patient Health Questionnaire (PHQ-9', 'No seizures or treatment-emergent mania/hypomania', 'Remission']","[{'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2063866', 'cui_str': 'Refractory Depression'}, {'cui': 'C0005586', 'cui_str': 'Psychosis, Manic-Depressive'}, {'cui': 'C0349217', 'cui_str': 'Depressive episode'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0332325', 'cui_str': 'Resistant (qualifier value)'}]","[{'cui': 'C0205212', 'cui_str': 'High frequency (qualifier value)'}, {'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}, {'cui': 'C0872259', 'cui_str': 'Transcranial Magnetic Stimulation, Repetitive'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C4517742', 'cui_str': '37.5 (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C4517612', 'cui_str': '18.75'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}]","[{'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}, {'cui': 'C4720917', 'cui_str': 'Quick inventory of depressive symptomatology (assessment scale)'}, {'cui': 'C1879301', 'cui_str': 'Patient Health Questionnaire'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0036572', 'cui_str': 'Seizures'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0338831', 'cui_str': 'Manic State'}, {'cui': 'C0241934', 'cui_str': 'Hypomanic mood (finding)'}]",30.0,0.0495395,"There were no significant differences in the remission rate between the conventional 37.5- and 18.75-minute protocol groups (46.7% and 40.0%, respectively).","[{'ForeName': 'Shinsuke', 'Initials': 'S', 'LastName': 'Kito', 'Affiliation': 'Department of Psychiatry, Jikei University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Midori', 'Initials': 'M', 'LastName': 'Miyazi', 'Affiliation': 'Medicalcare Toranomon Clinic, Tokyo, Japan.'}, {'ForeName': 'Honoka', 'Initials': 'H', 'LastName': 'Nakatani', 'Affiliation': 'Medicalcare Toranomon Clinic, Tokyo, Japan.'}, {'ForeName': 'Yuki', 'Initials': 'Y', 'LastName': 'Matsuda', 'Affiliation': 'Department of Psychiatry, Jikei University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Ryuichi', 'Initials': 'R', 'LastName': 'Yamazaki', 'Affiliation': 'Department of Psychiatry, Jikei University School of Medicine, Tokyo, Japan.'}, {'ForeName': 'Tatsuya', 'Initials': 'T', 'LastName': 'Okamoto', 'Affiliation': 'Medicalcare Toranomon Clinic, Tokyo, Japan.'}, {'ForeName': 'Yoshio', 'Initials': 'Y', 'LastName': 'Igarashi', 'Affiliation': 'Medicalcare Toranomon Clinic, Tokyo, Japan.'}]",Neuropsychopharmacology reports,['10.1002/npr2.12066'] 3270,31160295,Excellent long-term survival of children with Down syndrome and standard-risk ALL: a report from the Children's Oncology Group.,"The Children's Cancer Group 1991 study was a clinical trial for children with National Cancer Institute standard-risk acute lymphoblastic leukemia (ALL). This trial demonstrated that 5 doses of vincristine and escalating IV methotrexate (MTX) without leucovorin rescue in the interim maintenance (IM) phases resulted in superior event-free survival (EFS) when compared with 2 doses of vincristine, oral (PO) MTX, PO mercaptopurine, and dexamethasone. This report describes a favorable outcome of this regimen in patients with Down syndrome (DS). Forty-four patients with DS were randomized to the arms containing PO MTX during IM, and 31 to those containing IV MTX. Ten-year EFS rates for patients with DS randomized to IV MTX vs PO MTX were 94.4% ± 5.4% vs 81.5% ± 6.6%, respectively. IV methotrexate with strict escalation parameters, as given in this study, was well tolerated, although the mean total tolerated dose received was lower in patients with DS than in those without DS. There was no increase in hepatic toxicity, systemic infections, or treatment-related deaths in patients with DS during IM on either the IV or PO MTX arms, as compared with those without DS. The incidence of mucositis was increased in patients with DS as compared with patients without DS, particularly among patients who received IV MTX. This trial was registered at www.clinicaltrials.gov as #NCT00005945.",2019,"There was no increase in hepatic toxicity, systemic infections, or treatment-related deaths in patients with DS during IM on either the IV or PO MTX arms, as compared with those without DS.","['patients with Down syndrome (DS', 'children with National Cancer Institute standard-risk acute lymphoblastic leukemia (ALL', 'Forty-four patients with DS', 'children with Down syndrome and standard-risk ALL']","['IV MTX', 'vincristine, oral (PO) MTX, PO mercaptopurine, and dexamethasone', 'MTX vs PO MTX', 'vincristine and escalating IV methotrexate (MTX) without leucovorin', 'PO MTX', 'MTX', 'IV methotrexate']","['superior event-free survival (EFS', 'hepatic toxicity, systemic infections, or treatment-related deaths', 'mean total tolerated dose', 'incidence of mucositis']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0013080', 'cui_str': '47,XY,+21'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C1513882', 'cui_str': 'National Cancer Institute'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C1961102', 'cui_str': 'Lymphocytic Leukemia, Acute'}, {'cui': 'C4319568', 'cui_str': '44'}]","[{'cui': 'C0042679', 'cui_str': 'Vincristine'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0000618', 'cui_str': 'mercaptopurine'}, {'cui': 'C0011777', 'cui_str': 'Dexamethasone'}, {'cui': 'C0025677', 'cui_str': 'Methotrexate'}, {'cui': 'C2721771', 'cui_str': 'levoleucovorin'}]","[{'cui': 'C1282910', 'cui_str': 'Upper (qualifier value)'}, {'cui': 'C4551700', 'cui_str': 'Event-Free Survival'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0243026', 'cui_str': 'Sepsis'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0333355', 'cui_str': 'Mucositis'}]",44.0,0.0428316,"There was no increase in hepatic toxicity, systemic infections, or treatment-related deaths in patients with DS during IM on either the IV or PO MTX arms, as compared with those without DS.","[{'ForeName': 'Yousif', 'Initials': 'Y', 'LastName': 'Matloub', 'Affiliation': ""Division of Hematology-Oncology, Rainbow Babies & Children's Hospital, Case Western Reserve University, Cleveland, OH.""}, {'ForeName': 'Karen R', 'Initials': 'KR', 'LastName': 'Rabin', 'Affiliation': 'Division of Pediatric Hematology/Oncology, College of Medicine, Baylor University, Houston, TX.'}, {'ForeName': 'Lingyun', 'Initials': 'L', 'LastName': 'Ji', 'Affiliation': 'Department of Preventive Medicine, Keck School of Medicine, University of Southern California, Los Angeles, CA.'}, {'ForeName': 'Meenakshi', 'Initials': 'M', 'LastName': 'Devidas', 'Affiliation': ""Department of Global Pediatric Medicine, St. Jude Children's Research Hospital, Memphis, TN.""}, {'ForeName': 'Johann', 'Initials': 'J', 'LastName': 'Hitzler', 'Affiliation': 'Division of Hematology/Oncology, The Hospital for Sick Children, Toronto, ON, Canada.'}, {'ForeName': 'Xinxin', 'Initials': 'X', 'LastName': 'Xu', 'Affiliation': ""Children's Oncology Group, Monrovia, CA.""}, {'ForeName': 'Bruce C', 'Initials': 'BC', 'LastName': 'Bostrom', 'Affiliation': ""Children's Hospitals and Clinics of Minnesota, Minneapolis, MN.""}, {'ForeName': 'Linda C', 'Initials': 'LC', 'LastName': 'Stork', 'Affiliation': ""Division of Hematology-Oncology, Doernbecher Children's Hospital, Oregon Health & Science University, Portland, OR.""}, {'ForeName': 'Naomi', 'Initials': 'N', 'LastName': 'Winick', 'Affiliation': 'Simmons Cancer Center-Dallas, UT Southwestern, Dallas, TX.'}, {'ForeName': 'Julie M', 'Initials': 'JM', 'LastName': 'Gastier-Foster', 'Affiliation': ""Institute for Genomic Medicine, Nationwide Children's Hospital, Columbus, OH.""}, {'ForeName': 'Nyla A', 'Initials': 'NA', 'LastName': 'Heerema', 'Affiliation': 'Department of Pathology and.'}, {'ForeName': 'Eileen', 'Initials': 'E', 'LastName': 'Stonerock', 'Affiliation': ""Institute for Genomic Medicine, Nationwide Children's Hospital, Columbus, OH.""}, {'ForeName': 'William L', 'Initials': 'WL', 'LastName': 'Carroll', 'Affiliation': 'Perlmutter Cancer Center and.'}, {'ForeName': 'Stephen P', 'Initials': 'SP', 'LastName': 'Hunger', 'Affiliation': 'Division of Oncology and.'}, {'ForeName': 'Paul S', 'Initials': 'PS', 'LastName': 'Gaynon', 'Affiliation': ""Division of Hematology-Oncology, Children's Hospital Los Angeles, University of Southern California, Los Angeles, CA.""}]",Blood advances,['10.1182/bloodadvances.2019032094'] 3271,30810347,"Pharmacokinetics of HLD200, a Delayed-Release and Extended-Release Methylphenidate: Evaluation of Dose Proportionality, Food Effect, Multiple-Dose Modeling, and Comparative Bioavailability with Immediate-Release Methylphenidate in Healthy Adults.","OBJECTIVES HLD200, an oral, once-daily, evening-dosed, delayed-release, and extended-release methylphenidate (DR/ER-MPH), was designed to provide efficacy from the early morning, throughout the day, and into the evening to individuals with attention-deficit/hyperactivity disorder. The objectives were to evaluate DR/ER-MPH pharmacokinetic (PK) properties in healthy adults, including dose proportionality, food effect, the potential of accumulation using multiple-dose modeling, and bioavailability compared to an immediate-release MPH (IR MPH). METHODS Three open-label, single-dose, crossover studies were conducted, all with a 7-day washout between treatments. In Study I, 20 subjects received evening-dosed DR/ER-MPH (20 and 100 mg) followed by a medium-fat breakfast; 13 subjects received a subsequent 100-mg dose of DR/ER-MPH followed by a low-fat breakfast. In Study II, 18 subjects were evaluated after receiving evening-dosed DR/ER-MPH (100 mg) under 3 conditions: immediately after a high-fat meal, sprinkled on applesauce, and in a fasted state. In Study III, 11 and 12 subjects received evening-dosed DR/ER-MPH (100 mg) and morning-dosed IR MPH (20 mg), respectively. RESULTS DR/ER-MPH demonstrated dose proportionality between 20- and 100-mg doses. DR/ER-MPH PK parameters were not significantly affected by breakfast content or by sprinkling capsule contents. A high-fat meal immediately preceding evening dosing did not affect total MPH exposure but lowered peak MPH exposure by 14% and 11% versus fasted and sprinkled states, and time to peak exposure was delayed by ∼2.5 hours; these PK differences are unlikely to be clinically significant. Based on multiple-dose simulations using data from Study I, negligible accumulation of DR/ER-MPH was predicted. The relative bioavailability for DR/ER-MPH compared to IR MPH was 73.9%. No serious adverse events (AEs) were reported, and the observed AEs were consistent with MPH. There were no discontinuations in Studies I and III, but three participants withdrew in Study II due to AEs. CONCLUSIONS Evening-dosed DR/ER-MPH demonstrated dose proportionality and can be administered with or without food. Significant accumulation is unlikely with multiple dosing.",2019,"A high-fat meal immediately preceding evening dosing did not affect total MPH exposure but lowered peak MPH exposure by 14% and 11% versus fasted and sprinkled states, and time to peak exposure was delayed by ∼2.5 hours; these PK differences are unlikely to be clinically significant.","['18 subjects were evaluated after receiving', 'individuals with attention-deficit/hyperactivity disorder', '20 subjects received', 'Healthy Adults', 'healthy adults']","['Immediate-Release Methylphenidate', 'methylphenidate (DR/ER-MPH', 'evening-dosed DR/ER-MPH', 'evening-dosed DR/ER-MPH (20 and 100\u2009mg) followed by a medium-fat breakfast; 13 subjects received a subsequent 100-mg dose of DR/ER-MPH followed by a low-fat breakfast', 'Methylphenidate']","['DR/ER-MPH pharmacokinetic (PK) properties', 'relative bioavailability', 'total MPH exposure', 'DR/ER-MPH PK parameters', 'peak MPH exposure', 'serious adverse events (AEs']","[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C1263846', 'cui_str': 'ADDH'}, {'cui': 'C0686750', 'cui_str': 'Well adult (finding)'}]","[{'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C1963578', 'cui_str': 'Release (procedure)'}, {'cui': 'C0025810', 'cui_str': 'Methylphenidate'}, {'cui': 'C0048853', 'cui_str': 'MPH'}, {'cui': 'C0587117', 'cui_str': 'Evening (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0439536', 'cui_str': 'Medium (qualifier value)'}, {'cui': 'C0015677', 'cui_str': 'Fats'}, {'cui': 'C4553621', 'cui_str': 'With breakfast'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}]","[{'cui': 'C0048853', 'cui_str': 'MPH'}, {'cui': 'C0031327', 'cui_str': 'Drug Kinetics'}, {'cui': 'C0871161', 'cui_str': 'Property (attribute)'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}, {'cui': 'C0005508', 'cui_str': 'Bioavailability'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}]",18.0,0.0401974,"A high-fat meal immediately preceding evening dosing did not affect total MPH exposure but lowered peak MPH exposure by 14% and 11% versus fasted and sprinkled states, and time to peak exposure was delayed by ∼2.5 hours; these PK differences are unlikely to be clinically significant.","[{'ForeName': 'Tao', 'Initials': 'T', 'LastName': 'Liu', 'Affiliation': '1 Center for Translational Medicine, School of Pharmacy, University of Maryland, Baltimore, Maryland.'}, {'ForeName': 'Jogarao V S', 'Initials': 'JVS', 'LastName': 'Gobburu', 'Affiliation': '1 Center for Translational Medicine, School of Pharmacy, University of Maryland, Baltimore, Maryland.'}, {'ForeName': 'Michelle D', 'Initials': 'MD', 'LastName': 'Po', 'Affiliation': '2 Highland Therapeutics Inc., Toronto, Ontario, Canada.'}, {'ForeName': 'Angus', 'Initials': 'A', 'LastName': 'McLean', 'Affiliation': '3 Ironshore Pharmaceuticals and Development, Inc., Camana Bay, Cayman Islands.'}, {'ForeName': 'Norberto J', 'Initials': 'NJ', 'LastName': 'DeSousa', 'Affiliation': '3 Ironshore Pharmaceuticals and Development, Inc., Camana Bay, Cayman Islands.'}, {'ForeName': 'Floyd R', 'Initials': 'FR', 'LastName': 'Sallee', 'Affiliation': '3 Ironshore Pharmaceuticals and Development, Inc., Camana Bay, Cayman Islands.'}, {'ForeName': 'Bev', 'Initials': 'B', 'LastName': 'Incledon', 'Affiliation': '3 Ironshore Pharmaceuticals and Development, Inc., Camana Bay, Cayman Islands.'}]",Journal of child and adolescent psychopharmacology,['10.1089/cap.2018.0122'] 3272,30842035,Acute stress improves long-term reward maximization in decision-making under uncertainty.,"Acute stress influences reward-seeking tendencies and risky decision-making. However, it is unclear how acute stress influences decision-making in situations in which individuals must learn to either maximize long-term or immediate rewards from experience. Consequently, this study sought to investigate whether acute stress enhances salience of small, immediate or large, delayed rewards on decision-making under uncertainty. The Socially Evaluated Cold Pressor Task (SECPT) was used to induce acute stress. Participants in Experiment 1 (N = 50) were exposed to either the SECPT or a warm-water control condition and then completed a decision-making task in which participants needed to learn to forego immediate rewards in favor of larger delayed rewards. The results demonstrated that acute stress enhanced decisions that maximized long-term, large rewards over immediate, small rewards. Experiment 2 (N = 50) included an assessment of salivary cortisol. Results replicated the behavioral findings in Experiment 1 and demonstrated that the acute stress manipulation increased salivary cortisol, thus providing a potential physiological mechanism for these results. This work suggests that moderate acute stress can improve decision-making under uncertainty that depends on learning to maximize long-term rewards from experience.",2019,Participants in Experiment 1 (N = 50) were exposed to either the SECPT or a warm-water control condition and then completed a decision-making task in which participants needed to learn to forego immediate rewards in favor of larger delayed rewards.,[],"['SECPT or a warm-water control condition and then completed a decision-making task in which participants needed to learn to forego immediate rewards in favor of larger delayed rewards', 'Socially Evaluated Cold Pressor Task (SECPT']","['assessment of salivary cortisol', 'salivary cortisol']",[],"[{'cui': 'C0184348', 'cui_str': 'Warmer'}, {'cui': 'C0043047', 'cui_str': 'Water'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0011109', 'cui_str': 'Decision Making'}, {'cui': 'C0027552', 'cui_str': 'Needs'}, {'cui': 'C0023185', 'cui_str': 'Learning'}, {'cui': 'C0205253', 'cui_str': 'Immediate (qualifier value)'}, {'cui': 'C0035397', 'cui_str': 'Rewards'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0444689', 'cui_str': 'Cold pressor test (procedure)'}]","[{'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0442040', 'cui_str': 'Salivary (qualifier value)'}, {'cui': 'C0201968', 'cui_str': 'Cortisol measurement (procedure)'}]",,0.0158774,Participants in Experiment 1 (N = 50) were exposed to either the SECPT or a warm-water control condition and then completed a decision-making task in which participants needed to learn to forego immediate rewards in favor of larger delayed rewards.,"[{'ForeName': 'Kaileigh A', 'Initials': 'KA', 'LastName': 'Byrne', 'Affiliation': 'Clemson University, United States. Electronic address: kaileib@clemson.edu.'}, {'ForeName': 'Astin C', 'Initials': 'AC', 'LastName': 'Cornwall', 'Affiliation': 'Texas A&M University, United States.'}, {'ForeName': 'Darrell A', 'Initials': 'DA', 'LastName': 'Worthy', 'Affiliation': 'Texas A&M University, United States.'}]",Brain and cognition,['10.1016/j.bandc.2019.02.005'] 3273,30252113,The Effects of a Life Stress Emotional Awareness and Expression Interview for Women with Chronic Urogenital Pain: A Randomized Controlled Trial.,"OBJECTIVE Women with chronic urogenital pain (CUP) conditions have elevated rates of lifetime trauma, relational stress, and emotional conflicts, but directly assessing and treating psychological stress is rarely done in women's health care settings. We developed and tested the effects on patients' somatic and psychological symptoms of a life stress interview that encourages disclosure about stressors and uses experiential techniques to increase awareness of links between stress, emotions, and symptoms. METHODS In this randomized trial, women with CUP recruited at a multidisciplinary women's urology center received either a single 90-minute life stress interview (N = 37) or no interview (treatment-as-usual control; N = 25). Self-report measures of pain severity (primary outcome), pain interference, pelvic floor symptoms, and psychological symptoms (anxiety and depression) were completed at baseline and six-week follow-up. RESULTS Differences between the life stress interview and control conditions at follow-up were tested with analyses of covariance, controlling for baseline level of the outcome and baseline depression. Compared with the control condition, the interview resulted in significantly lower pain severity and pelvic floor symptoms, but the interview had no effect on pain interference or psychological symptoms. CONCLUSIONS An intensive life stress emotional awareness expression interview improved physical but not psychological symptoms among women with CUP seen in a tertiary care clinic. This study suggests that targeting stress and avoided emotions and linking them to symptoms may be beneficial for this complex group of patients.",2019,"Compared with the control condition, the interview resulted in significantly lower pain severity and pelvic floor symptoms, but the interview had no effect on pain interference or psychological symptoms. ","['Objective\n\n\nWomen with chronic urogenital pain (CUP', ""women with CUP recruited at a multidisciplinary women's urology center received either a"", 'Women with Chronic Urogenital Pain', 'women with CUP seen in a tertiary care clinic']","['Life Stress Emotional Awareness and Expression Interview', 'single 90-minute life stress interview (N\u2009=\u200937) or no interview (treatment-as-usual control; N\u2009=\u200925']","['pain severity and pelvic floor symptoms', 'pain interference or psychological symptoms', 'pain severity (primary outcome), pain interference, pelvic floor symptoms, and psychological symptoms (anxiety and depression', 'awareness of links between stress, emotions, and symptoms']","[{'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C2949743', 'cui_str': 'Cup - unit of product usage'}, {'cui': 'C0042077', 'cui_str': 'Urology'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C3494403', 'cui_str': 'Tertiary Care'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}]","[{'cui': 'C0038443', 'cui_str': 'Stressor, Psychological'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0004448', 'cui_str': 'Situational Awareness'}, {'cui': 'C3854321', 'cui_str': 'Expression'}, {'cui': 'C0935630', 'cui_str': 'Interview'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0439232', 'cui_str': 'min (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0206248', 'cui_str': 'Pelvic Diaphragm'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C0233397', 'cui_str': 'Psychological symptom'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0004448', 'cui_str': 'Situational Awareness'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0013987', 'cui_str': 'Emotions'}]",,0.101268,"Compared with the control condition, the interview resulted in significantly lower pain severity and pelvic floor symptoms, but the interview had no effect on pain interference or psychological symptoms. ","[{'ForeName': 'Jennifer N', 'Initials': 'JN', 'LastName': 'Carty', 'Affiliation': 'Department of Psychology, Wayne State University, Detroit, Michigan.'}, {'ForeName': 'Maisa S', 'Initials': 'MS', 'LastName': 'Ziadni', 'Affiliation': 'Department of Psychology, Wayne State University, Detroit, Michigan.'}, {'ForeName': 'Hannah J', 'Initials': 'HJ', 'LastName': 'Holmes', 'Affiliation': 'Department of Psychology, Wayne State University, Detroit, Michigan.'}, {'ForeName': 'Janice', 'Initials': 'J', 'LastName': 'Tomakowsky', 'Affiliation': ""Women's Urology, Beaumont Health System, Royal Oak, Michigan.""}, {'ForeName': 'Kenneth', 'Initials': 'K', 'LastName': 'Peters', 'Affiliation': ""Women's Urology, Beaumont Health System, Royal Oak, Michigan.""}, {'ForeName': 'Howard', 'Initials': 'H', 'LastName': 'Schubiner', 'Affiliation': 'Department of Internal Medicine, Ascension Health / Providence-Providence Park Hospital, Michigan State University College of Human Medicine, Southfield, Michigan.'}, {'ForeName': 'Mark A', 'Initials': 'MA', 'LastName': 'Lumley', 'Affiliation': 'Department of Psychology, Wayne State University, Detroit, Michigan.'}]","Pain medicine (Malden, Mass.)",['10.1093/pm/pny182'] 3274,31945165,The effect of training for a participatory ergonomic intervention on physical exertion and musculoskeletal pain among childcare workers (the TOY project) - a wait-list cluster-randomized controlled trial.,"Objective Many employees have high physical exertion at work and suffer from musculoskeletal pain (MSP) leading to sickness absence with large costs. Participatory ergonomics is a potentially effective intervention for reducing physical exertion, MSP and sickness absence. The main aim of this study was to investigate the effectiveness of a 20-week workplace participatory ergonomic intervention among childcare workers on physical exertion and MSP. Methods In a two-arm cluster-randomized trial, 190 workers were recruited from 16 childcare institutions and randomly assigned to either a 20-week participatory ergonomics intervention consisting of three training workshops or a control group receiving usual care. Primary outcomes were physical exertion during work, maximal pain intensity, number of pain regions, and pain-related work interference. Secondary outcomes were MSP-related sickness absence, need for recovery (NFR), employee involvement, and self-efficacy. We followed the intention-to-treat principle and adhered to the registered study protocol (ISRCTN10928313). Results After 20 weeks, half the workers noticed some positive changes in their work. However, there were no statistically discernible effects in physical exertion, maximum pain intensity, pain-related work interference, or number of pain regions. We found a significant reduction of MSP-related sickness absence in the intervention compared to the control group [-0.48 days per month (95% confidence interval (CI), -0.8- -0.1]. We found no significant effects in NRF or involvement of employees, but self-efficacy was reduced in the intervention compared to the control group [-0.2 (95% CI, -0.3- -0.0)]. Conclusion This 20-week training for a participatory ergonomic intervention in childcare workers did not show effects on physical exertion and MSP, but was both feasible and effective in reducing MSP-related sickness absence.",2020,"This 20-week training for a participatory ergonomic intervention in childcare workers did not show effects on physical exertion and MSP, but was both feasible and effective in reducing MSP-related sickness absence.","['childcare workers on physical exertion and MSP', 'childcare workers', '190 workers were recruited from 16 childcare institutions']","['participatory ergonomic intervention', '20-week workplace participatory ergonomic intervention', '20-week participatory ergonomics intervention consisting of three training workshops or a control group receiving usual care']","['MSP-related sickness absence, need for recovery (NFR), employee involvement, and self-efficacy', 'physical exertion, MSP and sickness absence', 'physical exertion during work, maximal pain intensity, number of pain regions, and pain-related work interference', 'physical exertion, maximum pain intensity, pain-related work interference, or number of pain regions', 'physical exertion and musculoskeletal pain', 'self-efficacy', 'MSP-related sickness absence']","[{'cui': 'C1306056', 'cui_str': 'Worker'}, {'cui': 'C0031807', 'cui_str': 'Physical Effort'}, {'cui': 'C4517622', 'cui_str': 'One hundred and ninety'}, {'cui': 'C1272753', 'cui_str': 'Institution'}]","[{'cui': 'C0086246', 'cui_str': 'Ergonomics'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0162579', 'cui_str': 'Job Site'}, {'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0242262', 'cui_str': 'Workshops'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0221423', 'cui_str': 'Illness (finding)'}, {'cui': 'C1689985', 'cui_str': 'Absence'}, {'cui': 'C0686904', 'cui_str': 'Patient need for (contextual qualifier) (qualifier value)'}, {'cui': 'C0599987', 'cui_str': 'Employee (person)'}, {'cui': 'C0205428', 'cui_str': 'Involvements (qualifier value)'}, {'cui': 'C0600564', 'cui_str': 'Self Efficacy'}, {'cui': 'C0031807', 'cui_str': 'Physical Effort'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C1320357', 'cui_str': 'Pain intensity'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0205147', 'cui_str': 'Region (attribute)'}, {'cui': 'C3698478', 'cui_str': 'Working interference'}, {'cui': 'C0026858', 'cui_str': 'Musculoskeletal Pain'}]",190.0,0.100345,"This 20-week training for a participatory ergonomic intervention in childcare workers did not show effects on physical exertion and MSP, but was both feasible and effective in reducing MSP-related sickness absence.","[{'ForeName': 'Charlotte Diana Nørregaard', 'Initials': 'CDN', 'LastName': 'Rasmussen', 'Affiliation': 'National Research Centre for the Working Environment, Lersø Parkallé 105, 2100 Copenhagen Ø, Denmark. cnr@nfa.dk.'}, {'ForeName': 'Ole Henning', 'Initials': 'OH', 'LastName': 'Sørensen', 'Affiliation': ''}, {'ForeName': 'Allard J', 'Initials': 'AJ', 'LastName': 'van der Beek', 'Affiliation': ''}, {'ForeName': 'Andreas', 'Initials': 'A', 'LastName': 'Holtermann', 'Affiliation': ''}]","Scandinavian journal of work, environment & health",['10.5271/sjweh.3884'] 3275,31992463,Inspiratory muscle training did not improve exercise capacity and lung function in adult patients with Fontan circulation: A randomized controlled trial.,"BACKGROUNDS Patients with Fontan circulation have no subpulmonary ventricle and a passive pulmonary perfusion. Considerable percentage of the pulmonary blood flow is driven by pressure shift due to respiration. Impairments in respiratory musculature strength are associated with a reduced exercise capacity. This study investigated the effect of a daily six months inspiratory muscle training (IMT) on exercise and lung capacity in adult Fontan patients. METHODS After a lung function and cardiopulmonary exercise test (CPET), 42 Fontan patients (50% female; 30.5 ± 8.1 years) were randomized into either an intervention group (IG), or a control group (CG). The IG performed a telephone-supervised, daily IMT of three sets with 10-30 repetitions for six months. RESULTS After six months of IMT, the IG did not improve in any exercise and lung capacity parameter compared to CG. VO 2 peak (ΔVO 2 peak: IG: 0.05 [-1.53; 1.33] ml/kg/min vs. CG: -0.50 [-1.20; 0.78] ml/kg/min; p = .784) and FVC (ΔFVC: IG: 0.07 [-0.16; 0.22] l vs. CG:-0.05 [-0.24; 0.18] l; p = .377) remained unchanged, while FEV1 trended to improve (ΔFEV 1 : IG: 0.05 [-0.07; 0.13] l vs. CG: -0.10 [-0.19; 0.03] l; p = .082). Only oxygen saturation at rest improved significantly (ΔSpO 2 : IG: 1.50 [-0.25; 3.00] % vs. CG: -0.50 [-1.75; 0.75] %; p = .017). CONCLUSIONS A daily six months IMT did not improve exercise and lung capacity and lung volumes in Fontan patients.",2020,VO 2 peak (ΔVO 2 peak: IG: 0.05 [-1.53; 1.33] ml/kg/min vs. CG: -0.50 [-1.20; 0.78] ml/kg/min; p = .784) and FVC (ΔFVC:,"['adult Fontan patients', 'Patients with Fontan circulation have no subpulmonary ventricle and a passive pulmonary perfusion', 'adult patients with Fontan circulation', '42 Fontan patients (50% female; 30.5\xa0±\xa08.1\xa0years', 'Fontan patients']","['cardiopulmonary exercise test (CPET', 'daily six months inspiratory muscle training (IMT', 'Inspiratory muscle training', 'CG', 'IMT', 'FVC (ΔFVC']","['exercise capacity and lung function', 'Only oxygen saturation', 'exercise and lung capacity and lung volumes', 'exercise and lung capacity', 'exercise and lung capacity parameter']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0018827', 'cui_str': 'Heart Ventricle'}, {'cui': 'C4522268', 'cui_str': 'Pulmonary'}, {'cui': 'C0031001', 'cui_str': 'Perfusion'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C4517875', 'cui_str': '8.1 (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C2959886', 'cui_str': 'Cardiopulmonary Exercise Test'}, {'cui': 'C0055954', 'cui_str': 'CPET'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C4082120', 'cui_str': 'Six months'}, {'cui': 'C0454511', 'cui_str': 'Inspiratory muscle training (regime/therapy)'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0024119', 'cui_str': 'Lung Function Tests'}, {'cui': 'C0523807', 'cui_str': 'Oximetry'}, {'cui': 'C0086571', 'cui_str': 'Lung Capacities'}, {'cui': 'C0231953', 'cui_str': 'Lung volume, function (observable entity)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}]",,0.0563516,VO 2 peak (ΔVO 2 peak: IG: 0.05 [-1.53; 1.33] ml/kg/min vs. CG: -0.50 [-1.20; 0.78] ml/kg/min; p = .784) and FVC (ΔFVC:,"[{'ForeName': 'Celina', 'Initials': 'C', 'LastName': 'Fritz', 'Affiliation': 'Department of Congenital Heart Disease and Pediatric Cardiology, Deutsches Herzzentrum München, Technical University of Munich, Germany. Electronic address: fritz@dhm.mhn.de.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Müller', 'Affiliation': 'Department of Congenital Heart Disease and Pediatric Cardiology, Deutsches Herzzentrum München, Technical University of Munich, Germany; Institute of Preventive Pediatrics, Department of Sport and Health Sciences, Technical University of Munich, Germany.'}, {'ForeName': 'Renate', 'Initials': 'R', 'LastName': 'Oberhoffer', 'Affiliation': 'Department of Congenital Heart Disease and Pediatric Cardiology, Deutsches Herzzentrum München, Technical University of Munich, Germany; Institute of Preventive Pediatrics, Department of Sport and Health Sciences, Technical University of Munich, Germany.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Ewert', 'Affiliation': 'Department of Congenital Heart Disease and Pediatric Cardiology, Deutsches Herzzentrum München, Technical University of Munich, Germany.'}, {'ForeName': 'Alfred', 'Initials': 'A', 'LastName': 'Hager', 'Affiliation': 'Department of Congenital Heart Disease and Pediatric Cardiology, Deutsches Herzzentrum München, Technical University of Munich, Germany.'}]",International journal of cardiology,['10.1016/j.ijcard.2020.01.015'] 3276,31558323,Long-term effectiveness of an E-based survivorship care plan for breast cancer survivors: A quasi-experimental study.,"OBJECTIVE The purpose of this study was to evaluate the effect of a web-based survivorship care plan (SCP) computerized application (APP): (SCP-A) on women's unmet needs, fear of recurrence, symptom distress, anxiety, depression, and quality of life (QoL). METHODS Women diagnosed with breast cancer, who had completed their primary treatment but less than 5 years without a sign of recurrence (N = 165) were randomized to a SCP-A or a control group. Self-reported questionnaires were completed by the both groups at baseline (T0), 5 weeks (T1), 3 months (T2), 6 months (T3), and 12 months (T4). RESULTS Controlling for relevant covariates, mixed effect model analyses revealed a significant decrease in women in the SCP-A group compared to the control group for total unmet needs since T3 (p < .004) and fear of recurrence since T4 (p = .02). Women in the SCP-A group also reported significant improvements in QoL at T4 (p < .001) relative to those in the control group. CONCLUSION Providing SCP using an information website application for women with breast cancer can decrease unmet needs, fear of recurrence, and improve quality of life during short-term and long-term use. PRACTICE IMPLICATIONS Web-based information that provides survivorship care plans for breast cancer survivors are beneficial.",2020,"Women in the SCP-A group also reported significant improvements in QoL at T4 (p < .001) relative to those in the control group. ","['Women diagnosed with breast cancer, who had completed their primary treatment but less than 5 years without a sign of recurrence (N\u202f=\u202f165', 'women with breast cancer', 'breast cancer survivors']","['SCP-A or a control group', 'E-based survivorship care plan', 'web-based survivorship care plan (SCP) computerized application (APP): (SCP-A']","['fear of recurrence since T4', 'QoL', 'quality of life', 'fear of recurrence, symptom distress, anxiety, depression, and quality of life (QoL']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0006142', 'cui_str': 'Breast Cancer'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0332288', 'cui_str': 'Without (attribute)'}, {'cui': 'C4319555', 'cui_str': '165 (qualifier value)'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}]","[{'cui': 'C1145610', 'cui_str': 'Cellulose sodium phosphate'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0038955'}, {'cui': 'C0178916', 'cui_str': 'Care plan (record artifact)'}, {'cui': 'C0332875', 'cui_str': 'Congenital webbing (morphologic abnormality)'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}]","[{'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0034380'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}, {'cui': 'C3887804', 'cui_str': 'Feeling distress'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}]",,0.052703,"Women in the SCP-A group also reported significant improvements in QoL at T4 (p < .001) relative to those in the control group. ","[{'ForeName': 'Su-Ying', 'Initials': 'SY', 'LastName': 'Fang', 'Affiliation': 'Department of Nursing, College of Medicine, National Cheng Kung University, No. 1, University Road, Tainan City, 701, Taiwan. Electronic address: suying@mail.ncku.edu.tw.'}, {'ForeName': 'Yu-Ling', 'Initials': 'YL', 'LastName': 'Wang', 'Affiliation': 'National Taiwan University Hospital Hsin-Chu Branch, Taiwan.'}, {'ForeName': 'Wen-Hsiang', 'Initials': 'WH', 'LastName': 'Lu', 'Affiliation': 'Department of Computer Science and Information Engineering, National Cheng Kung University, Tainan, Taiwan.'}, {'ForeName': 'Kuo-Ting', 'Initials': 'KT', 'LastName': 'Lee', 'Affiliation': 'Department of Surgery, National Cheng Kung University Hospital, Tainan, Taiwan & Department of Surgery, College of Medicine, National Cheng Kung University, Tainan, Taiwan.'}, {'ForeName': 'Yao-Lung', 'Initials': 'YL', 'LastName': 'Kuo', 'Affiliation': 'Department of Surgery, National Cheng Kung University Hospital, Tainan and Dou-Liou Branch, Taiwan; Department of Surgery, College of Medicine, National Cheng Kung University, Tainan and Dou-Liou Branch, Taiwan.'}, {'ForeName': 'Susan Jane', 'Initials': 'SJ', 'LastName': 'Fetzer', 'Affiliation': 'Southern New Hampshire Medical Center, Nashua, NH, USA.'}]",Patient education and counseling,['10.1016/j.pec.2019.09.012'] 3277,31554943,Effect of multiple subconjunctival conbercept injections as an adjuvant to the surgical treatment of pterygium: a prospective randomised comparative 6-month follow-up study.,"OBJECTIVE To evaluate the safety and efficacy of multiple subconjunctival injections of conbercept for pterygium patients after surgery. METHODS As a prospective randomised interventional trial, 96 eyes from 96 patients with a tendency to recur were collected and divided randomly into conbercept and 5-fluorouracil groups on the 5th day after pterygium. All patients received three subconjunctival injections of conbercept (0.2 ml) or 5-fluorouracil (0.2 ml) on the 5th day (baseline), and 2 and 4 weeks post-operatively. The pterygium morphology, colour intensity, recurrence, and complications were recorded and analysed pre-1st injection and 1 day, 1 week, 1 month, 3 months, and 6 months post-3rd injection. Moreover, no patient was drop-out. RESULTS There were striking differences between the two groups on post-3rd injections 1 day, 1 week, 1 month, 3 months, and 6 months (p = 0.001, 0.002, 0.000, 0.000, and 0.002, respectively) with respect to colour intensity: the eyes in conbercept group were lighter than the 5-Fu group. On post-3rd injection 6 months, prominent disparities existed between the two groups with respect to pterygium morphology (p = 0.006) and recurrence (p = 0.002), occurred in the conbercept group prior to the 5-Fu group. Moreover, corneal abrasions were not noted in the conbercept group, which was significantly less than the 5-Fu group (17/48; p = 0.000). There was no conspicuous discrepancy between the two groups with respect to subconjunctival haemorrhage (p = 0.789) and persistent epithelial defects (p = 0.078). CONCLUSION Multiple subconjunctival conbercept injections as an adjunct therapy for pterygium surgery was shown to be safe, effective, and well-tolerated.",2020,"On post-3rd injection 6 months, prominent disparities existed between the two groups with respect to pterygium morphology (p = 0.006) and recurrence (p = 0.002), occurred in the conbercept group prior to the 5-Fu group.","['pterygium', '96 eyes from 96 patients with a tendency to recur', 'pterygium patients after surgery']","['5-Fu', 'multiple subconjunctival conbercept injections', 'conbercept and 5-fluorouracil', 'multiple subconjunctival injections of conbercept', 'subconjunctival injections of conbercept (0.2\u2009ml) or 5-fluorouracil']","['corneal abrasions', 'pterygium morphology, colour intensity, recurrence, and complications', 'subconjunctival haemorrhage', 'persistent epithelial defects', 'safe, effective, and well-tolerated', 'recurrence', 'pterygium morphology', 'safety and efficacy']","[{'cui': 'C0033999', 'cui_str': 'Pterygium'}, {'cui': 'C0015392', 'cui_str': 'Eye'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}]","[{'cui': 'C0016360', 'cui_str': 'Fluorouracil'}, {'cui': 'C0439064', 'cui_str': 'Numerous (qualifier value)'}, {'cui': 'C0442183', 'cui_str': 'Subconjunctival (qualifier value)'}, {'cui': 'C2352201', 'cui_str': 'KH902 fusion protein'}, {'cui': 'C1272883', 'cui_str': 'Injection'}, {'cui': 'C0197180', 'cui_str': 'Subconjunctival injection (procedure)'}, {'cui': 'C4517436', 'cui_str': '0.2'}]","[{'cui': 'C0010032', 'cui_str': 'Corneal abrasion (disorder)'}, {'cui': 'C0033999', 'cui_str': 'Pterygium'}, {'cui': 'C0543482', 'cui_str': 'morphology'}, {'cui': 'C0009393', 'cui_str': 'Color'}, {'cui': 'C4049786', 'cui_str': 'Intensities'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C0038534', 'cui_str': 'Subconjunctival hemorrhage (disorder)'}, {'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",,0.0163744,"On post-3rd injection 6 months, prominent disparities existed between the two groups with respect to pterygium morphology (p = 0.006) and recurrence (p = 0.002), occurred in the conbercept group prior to the 5-Fu group.","[{'ForeName': 'Jing', 'Initials': 'J', 'LastName': 'Zhang', 'Affiliation': 'Department of Ophthalmology, Zhongnan Hospital of Wuhan University, No 169. Donghu Road, 430071, Wuhan, Hubei, China.'}, {'ForeName': 'Quanxi', 'Initials': 'Q', 'LastName': 'Tian', 'Affiliation': 'School of Information Management and statistics, Hubei University of Economics, No. 8 Yangqiaohu Road, 430205, Wuhan, Hubei, China.'}, {'ForeName': 'Tian', 'Initials': 'T', 'LastName': 'Zheng', 'Affiliation': 'Department of Ophthalmology, Zhongnan Hospital of Wuhan University, No 169. Donghu Road, 430071, Wuhan, Hubei, China.'}, {'ForeName': 'Donglai', 'Initials': 'D', 'LastName': 'Chen', 'Affiliation': ""Department of Ophthalmology, The Second People's Hospital of Honghu, No 142. Xinjian Road, 433202, Honghu, Hubei, China.""}, {'ForeName': 'Qing', 'Initials': 'Q', 'LastName': 'Wang', 'Affiliation': 'Department of Ophthalmology, Zhongnan Hospital of Wuhan University, No 169. Donghu Road, 430071, Wuhan, Hubei, China.'}, {'ForeName': 'Min', 'Initials': 'M', 'LastName': 'Ke', 'Affiliation': 'Department of Ophthalmology, Zhongnan Hospital of Wuhan University, No 169. Donghu Road, 430071, Wuhan, Hubei, China. keminyk@163.com.'}]","Eye (London, England)",['10.1038/s41433-019-0596-7'] 3278,31103547,Sex Differences in the Relationship Between Inflammation and Reward Sensitivity: A Randomized Controlled Trial of Endotoxin.,"BACKGROUND There are robust sex differences in the prevalence of depression. Inflammation and anhedonia may play a role in understanding these sex differences. Indeed, sex differences in inflammation-induced neural responses to reward may provide insight into the sex gaps in depression, but no study has examined this question. METHODS As such, the current study examined whether there were sex differences in reward-related neural activity (i.e., ventral striatum [VS] activity) in response to an experimental inflammatory challenge. Human participants (N = 115; 69 female) were randomly assigned to receive either placebo or low-dose endotoxin, which increases inflammation in a safe, time-limited manner. Two hours after receiving placebo or endotoxin (the height of the inflammatory response to endotoxin), participants completed a task in which they anticipated monetary reward in a functional magnetic resonance imaging scanner. RESULTS Results demonstrated that endotoxin (vs. placebo) led to reduced VS activity in anticipation of reward and that there were sex differences in this effect. Specifically, in female participants, endotoxin (vs. placebo) led to decreased VS activity in anticipation of reward, but this effect was not present in male participants. In addition, within the endotoxin condition, decreases in VS activity in anticipation of reward were related to increases in inflammation for female but not male participants. CONCLUSIONS These findings may have implications for understanding how inflammation may contribute to sex differences in rates of depression.",2019,"Specifically, in female participants, endotoxin (vs. placebo) led to decreased VS activity in anticipation of reward, but this effect was not present in male participants.",['Human participants (N\xa0= 115; 69 female'],"['placebo or endotoxin', 'Endotoxin', 'placebo or low-dose endotoxin', 'endotoxin (vs. placebo']",['VS activity'],"[{'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C4517540', 'cui_str': '115 (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0014264', 'cui_str': 'Endotoxins'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}]","[{'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}]",,0.265675,"Specifically, in female participants, endotoxin (vs. placebo) led to decreased VS activity in anticipation of reward, but this effect was not present in male participants.","[{'ForeName': 'Mona', 'Initials': 'M', 'LastName': 'Moieni', 'Affiliation': 'Department of Psychology, Cousins Center for Psychoneuroimmunology, University of California, Los Angeles, Los Angeles; California; Semel Institute for Neuroscience and Human Behavior, Cousins Center for Psychoneuroimmunology, University of California, Los Angeles, Los Angeles; California.'}, {'ForeName': 'Kevin M', 'Initials': 'KM', 'LastName': 'Tan', 'Affiliation': 'Department of Psychology, Cousins Center for Psychoneuroimmunology, University of California, Los Angeles, Los Angeles; California.'}, {'ForeName': 'Tristen K', 'Initials': 'TK', 'LastName': 'Inagaki', 'Affiliation': 'Department of Psychology, University of Pittsburgh, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Keely A', 'Initials': 'KA', 'LastName': 'Muscatell', 'Affiliation': 'Department of Psychology and Neuroscience, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina; Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina.'}, {'ForeName': 'Janine M', 'Initials': 'JM', 'LastName': 'Dutcher', 'Affiliation': 'Department of Psychology, Carnegie Mellon University, Pittsburgh, Pennsylvania.'}, {'ForeName': 'Ivana', 'Initials': 'I', 'LastName': 'Jevtic', 'Affiliation': 'Department of Psychology, Cousins Center for Psychoneuroimmunology, University of California, Los Angeles, Los Angeles; California.'}, {'ForeName': 'Elizabeth C', 'Initials': 'EC', 'LastName': 'Breen', 'Affiliation': 'Semel Institute for Neuroscience and Human Behavior, Cousins Center for Psychoneuroimmunology, University of California, Los Angeles, Los Angeles; California.'}, {'ForeName': 'Michael R', 'Initials': 'MR', 'LastName': 'Irwin', 'Affiliation': 'Semel Institute for Neuroscience and Human Behavior, Cousins Center for Psychoneuroimmunology, University of California, Los Angeles, Los Angeles; California.'}, {'ForeName': 'Naomi I', 'Initials': 'NI', 'LastName': 'Eisenberger', 'Affiliation': 'Department of Psychology, Cousins Center for Psychoneuroimmunology, University of California, Los Angeles, Los Angeles; California. Electronic address: neisenbe@ucla.edu.'}]",Biological psychiatry. Cognitive neuroscience and neuroimaging,['10.1016/j.bpsc.2019.03.010'] 3279,32058231,"Comments on ""A pilot cluster-randomised study to increase sleep duration by decreasing electronic media use at night and caffeine consumption in adolescents"".",,2020,,['adolescents'],[],[],"[{'cui': 'C0205653', 'cui_str': 'Adolescent'}]",[],[],,0.0168707,,"[{'ForeName': 'S M J', 'Initials': 'SMJ', 'LastName': 'Mortazavi', 'Affiliation': 'Medical Physics Department, School of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran; Diagnostic Imaging Department, Fox Chase Cancer Center, 333 Cottman Avenue, Philadelphia, PA 19111, USA. Electronic address: mortazavismj@gmail.com.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Abbasi', 'Affiliation': 'Medical Physics Department, School of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'S A R', 'Initials': 'SAR', 'LastName': 'Mortazavi', 'Affiliation': 'School of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran.'}]",Sleep medicine,['10.1016/j.sleep.2019.12.028'] 3280,31227530,Induction of labour in case of premature rupture of membranes at term with an unfavourable cervix: protocol for a randomised controlled trial comparing double balloon catheter (+oxytocin) and vaginal prostaglandin (RUBAPRO) treatments.,"INTRODUCTION Premature rupture of membranes (PROM) occurs at term in 8% of pregnancies. Several studies have demonstrated that the risk of chorioamnionitis and neonatal sepsis increases with duration of PROM. Decreasing the time interval between PROM and delivery is associated with lower rates of maternal infections. In case of an unfavourable cervix, the use of prostaglandin for cervical maturation demonstrates some advantages over oxytocin. The use of double balloon catheter in reduction of PROM duration has not been evaluated in the literature. METHODS AND ANALYSIS We are conducting a prospective, monocentric, randomised clinical trial on pregnant women with an unfavourable cervix showing PROM at term (RUBAPRO).After 12-24 hours of PROM, women are randomly assigned to one group treated with a double balloon catheter for 12 hours, with oxytocin administered after 6 hours or to the control group treated with 24 hours of vaginal prostaglandin followed by oxytocin infusion alone. Patients (n=80) are randomised at a 1:1 ratio with stratification on parity.The inclusion criteria are a Bishop score of <6, cephalic presentation at term and confirmed PROM. Women with suspected chorioamnionitis; group B streptococcus (GBS) carrier; a history of caesarean delivery or any contraindication for vaginal delivery are excluded.The time from induction to delivery is the primary outcome. Secondary outcomes were mode of delivery, maternofetal morbidity and the effect of parity on strategies for reduction of PROM duration.To sufficiently demonstrate a difference (10 hours) between groups-with a statistical power of 90% and a two-tailed α of 5%-40 patients per group will be required. ETHICS AND DISSEMINATION Written informed consent is required from participants.National Ethics Committee approval was obtained in August 2017. The results will be published in a peer-reviewed journal and presented at relevant conferences. Access to raw data will be available only to members of the research team. TRIAL REGISTRATION NUMBER NCT03310333.",2019,Decreasing the time interval between PROM and delivery is associated with lower rates of maternal infections.,"['pregnant women with an unfavourable cervix showing PROM at term (RUBAPRO).After 12-24\u2009hours of PROM, women', 'Patients (n=80', 'Women with suspected chorioamnionitis']","['oxytocin administered after 6\u2009hours or to the control group treated with 24\u2009hours of vaginal prostaglandin followed by oxytocin infusion alone', 'double balloon catheter', 'double balloon catheter (+oxytocin) and vaginal prostaglandin (RUBAPRO']","['mode of delivery, maternofetal morbidity and the effect of parity on strategies for reduction of PROM duration', 'PROM duration']","[{'cui': 'C0033011', 'cui_str': 'Pregnant Women'}, {'cui': 'C0007874', 'cui_str': 'Uterine Cervix'}, {'cui': 'C0015944', 'cui_str': 'Premature Rupture of Membrane (Pregnancy)'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0750491', 'cui_str': 'Suspected (qualifier value)'}, {'cui': 'C0008495', 'cui_str': 'Chorioamnionitis'}]","[{'cui': 'C0030095', 'cui_str': 'Oxytocin'}, {'cui': 'C1621583', 'cui_str': 'Administer'}, {'cui': 'C1292428', 'cui_str': '6 hours (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0439584', 'cui_str': '24 hours (qualifier value)'}, {'cui': 'C4521343', 'cui_str': 'Vaginal (intended site)'}, {'cui': 'C0356622', 'cui_str': 'Prostaglandins, oxytocics'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0441127', 'cui_str': 'Balloon dilatation catheter (physical object)'}]","[{'cui': 'C0011209', 'cui_str': 'Obstetric Delivery'}, {'cui': 'C0026538', 'cui_str': 'Morbidity'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0030563', 'cui_str': 'Parity'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0015944', 'cui_str': 'Premature Rupture of Membrane (Pregnancy)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}]",,0.233479,Decreasing the time interval between PROM and delivery is associated with lower rates of maternal infections.,"[{'ForeName': 'Eric', 'Initials': 'E', 'LastName': 'Devillard', 'Affiliation': 'Obstetrics and Gynaecology Department, Clermont-Ferrand University Hospital, Clermont-Ferrand, France.'}, {'ForeName': 'Amélie', 'Initials': 'A', 'LastName': 'Delabaere', 'Affiliation': 'Obstetrics and Gynaecology Department, Clermont-Ferrand University Hospital, Clermont-Ferrand, France.'}, {'ForeName': 'Marion', 'Initials': 'M', 'LastName': 'Rouzaire', 'Affiliation': 'Obstetrics and Gynaecology Department, Clermont-Ferrand University Hospital, Clermont-Ferrand, France.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Pereira', 'Affiliation': 'Biostatistics 1 Unit, Clermont-Ferrand University Hospital, Clermont-Ferrand, France.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Accoceberry', 'Affiliation': 'Obstetrics and Gynaecology Department, Clermont-Ferrand University Hospital, Clermont-Ferrand, France.'}, {'ForeName': 'Céline', 'Initials': 'C', 'LastName': 'Houlle', 'Affiliation': 'Obstetrics and Gynaecology Department, Clermont-Ferrand University Hospital, Clermont-Ferrand, France.'}, {'ForeName': 'Lydie', 'Initials': 'L', 'LastName': 'Dejou-Bouillet', 'Affiliation': 'Obstetrics and Gynaecology Department, Clermont-Ferrand University Hospital, Clermont-Ferrand, France.'}, {'ForeName': 'Pamela', 'Initials': 'P', 'LastName': 'Bouchet', 'Affiliation': 'Obstetrics and Gynaecology Department, Clermont-Ferrand University Hospital, Clermont-Ferrand, France.'}, {'ForeName': 'Denis', 'Initials': 'D', 'LastName': 'Gallot', 'Affiliation': 'Obstetrics and Gynaecology Department, Clermont-Ferrand University Hospital, Clermont-Ferrand, France.'}]",BMJ open,['10.1136/bmjopen-2018-026090'] 3281,31227535,Protocol for a double-blind placebo-controlled trial to evaluate the efficacy of probiotics in reducing antibiotics for infection in care home residents: the Probiotics to Reduce Infections iN CarE home reSidentS (PRINCESS) trial.,"INTRODUCTION Care home residents are at increased risk of infections and antibiotic prescription. Reduced antibiotic use from fewer infections would improve quality of life. The P robiotics to R educe I nfections i N C ar E home re S ident S (PRINCESS) trial aims to determine the efficacy and investigate mechanisms of daily probiotics on antibiotic use and incidence of infections in care home residents. METHODS AND ANALYSIS PRINCESS is a double-blind, individually randomised, placebo-controlled trial that will assess the effect of a daily oral probiotic combination of Lactobacillus rhamnosus, GG (LGG) and Bifidobacterium animalis subsp. lactis , BB-12 (BB-12) on cumulative antibiotic administration days (CAADs) (primary outcome) for infection in up to 330 care home residents aged ≥65 years over up to 12 months. Secondary outcomes include: Infection: Total number of days of antibiotic administration for each infection type (respiratory tract infection, urinary tract infection, gastrointestinal infection, unexplained fever and other); number, site, duration of infection; estimation of incidence and duration of diarrhoea and antibiotic-associated diarrhoea; Stool microbiology : Clostridium difficile infection; Gram-negative Enterobacteriaceae and vancomycin-resistant enterococci; LGG and BB-12. Oral microbiology: Candida spp. Health and well-being: Self and/or proxy health-related quality of life EQ5D (5 L); self-and/or proxy-reported ICEpop CAPability measure for older people. Hospitalisations: number and duration of all-cause hospital stays. Mortality: deaths. Mechanistic immunology outcomes: influenza vaccine efficacy (haemagglutination inhibition assay and antibody titres); full blood count and immune cell phenotypes, plasma cytokines and chemokines; cytokine and chemokine response in whole blood stimulated ex vivo by toll-like receptor 2 and 4 agonists; monocyte and neutrophil phagocytosis of Escherichia coli ; serum vitamin D. ETHICS AND DISSEMINATION Ethics approval is from the Wales Research Ethics Committee 3. Findings will be disseminated through peer-reviewed journals and conferences; results will be of interest to patient and policy stakeholders. TRIAL REGISTRATION NUMBER ISRCTN16392920; Pre-results.",2019,"influenza vaccine efficacy (haemagglutination inhibition assay and antibody titres); full blood count and immune cell phenotypes, plasma cytokines and chemokines; cytokine and chemokine response in whole blood stimulated ex vivo by toll-like receptor 2 and 4 agonists; monocyte and neutrophil phagocytosis of Escherichia coli ; serum vitamin D. ETHICS AND DISSEMINATION Ethics approval is from the Wales Research Ethics Committee 3.","['care home residents', 'older people', '330 care home residents aged ≥65 years over up to 12\u2009months']","['probiotics', 'daily oral probiotic combination of Lactobacillus rhamnosus, GG (LGG) and Bifidobacterium animalis subsp', 'placebo', 'self-and/or proxy-reported ICEpop CAPability measure']","['influenza vaccine efficacy (haemagglutination inhibition assay and antibody titres); full blood count and immune cell phenotypes, plasma cytokines and chemokines; cytokine and chemokine response', 'lactis , BB-12 (BB-12) on cumulative antibiotic administration days (CAADs', 'Mortality: deaths', ' Infection: Total number of days of antibiotic administration for each infection type (respiratory tract infection, urinary tract infection, gastrointestinal infection, unexplained fever and other); number, site, duration of infection; estimation of incidence and duration of diarrhoea and antibiotic-associated diarrhoea; Stool microbiology : Clostridium difficile infection; Gram-negative Enterobacteriaceae and vancomycin-resistant enterococci; LGG and BB-12. Oral microbiology: Candida spp', 'quality of life']","[{'cui': 'C0442519', 'cui_str': 'Domestic (environment)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C4517719', 'cui_str': '330 (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}]","[{'cui': 'C0525033', 'cui_str': 'Probiotics'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0317597', 'cui_str': 'Lactobacillus casei rhamnosus'}, {'cui': 'C0005380', 'cui_str': 'Bifidobacterium'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0600420', 'cui_str': 'Proxy'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}]","[{'cui': 'C0021403', 'cui_str': 'Influenza Vaccines'}, {'cui': 'C0018904', 'cui_str': 'Hemagglutination Inhibition Tests'}, {'cui': 'C1287242', 'cui_str': 'Finding of antibody titer (finding)'}, {'cui': 'C0009555', 'cui_str': 'Complete Blood Count'}, {'cui': 'C0439662', 'cui_str': 'Immune (qualifier value)'}, {'cui': 'C0427385', 'cui_str': 'Cell phenotype determination'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0079189', 'cui_str': 'Cytokine (substance)'}, {'cui': 'C0282554', 'cui_str': 'Cytokines, Chemotactic'}, {'cui': 'C0003232', 'cui_str': 'Antibiotics'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C3714514', 'cui_str': 'Infection'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0441704', 'cui_str': 'Typings (qualifier value)'}, {'cui': 'C0035243', 'cui_str': 'Infections, Respiratory'}, {'cui': 'C0042029', 'cui_str': 'Urinary tract infectious disease (disorder)'}, {'cui': 'C4082764', 'cui_str': 'Infection of gastrointestinal tract'}, {'cui': 'C0015967', 'cui_str': 'Hyperthermia'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C0011991', 'cui_str': 'Diarrhea'}, {'cui': 'C0015733', 'cui_str': 'Feces'}, {'cui': 'C0085672', 'cui_str': 'Microbiology procedure (procedure)'}, {'cui': 'C0343386', 'cui_str': 'Clostridium difficile infection (disorder)'}, {'cui': 'C0439208', 'cui_str': 'gram (qualifier value)'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0014346', 'cui_str': 'Coliform Bacilli'}, {'cui': 'C1265175', 'cui_str': 'Vancomycin-Resistant Enterococci'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0006836', 'cui_str': 'Monilia'}, {'cui': 'C0075148', 'cui_str': 'stable plasma protein solution'}, {'cui': 'C0034380'}]",,0.229602,"influenza vaccine efficacy (haemagglutination inhibition assay and antibody titres); full blood count and immune cell phenotypes, plasma cytokines and chemokines; cytokine and chemokine response in whole blood stimulated ex vivo by toll-like receptor 2 and 4 agonists; monocyte and neutrophil phagocytosis of Escherichia coli ; serum vitamin D. ETHICS AND DISSEMINATION Ethics approval is from the Wales Research Ethics Committee 3.","[{'ForeName': 'Eleri', 'Initials': 'E', 'LastName': 'Owen-Jones', 'Affiliation': 'Centre for Trials Research, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Rachel', 'Initials': 'R', 'LastName': 'Lowe', 'Affiliation': 'Centre for Trials Research, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Mark', 'Initials': 'M', 'LastName': 'Lown', 'Affiliation': 'Primary Care and Population Sciences, University of Southampton, Aldermoor Health Centre, Southampton, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Gillespie', 'Affiliation': 'Centre for Trials Research, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Katy', 'Initials': 'K', 'LastName': 'Addison', 'Affiliation': 'Centre for Trials Research, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Tony', 'Initials': 'T', 'LastName': 'Bayer', 'Affiliation': 'Division of Population Medicine, School of Medicine, Neuadd Meirionnydd, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Philip C', 'Initials': 'PC', 'LastName': 'Calder', 'Affiliation': 'Human Development & Health, Faculty of Medicine, University of Southampton, Southampton, UK.'}, {'ForeName': 'Jane', 'Initials': 'J', 'LastName': 'Davies', 'Affiliation': 'Centre for Trials Research, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Mina', 'Initials': 'M', 'LastName': 'Davoudianfar', 'Affiliation': 'Clinical Trials Unit, Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'James', 'Initials': 'J', 'LastName': 'Downs', 'Affiliation': 'Lay Representative, Cardiff, UK.'}, {'ForeName': 'Alison', 'Initials': 'A', 'LastName': 'Edwards', 'Affiliation': 'Centre for Trials Research, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Nick A', 'Initials': 'NA', 'LastName': 'Francis', 'Affiliation': 'Division of Population Medicine, School of Medicine, Neuadd Meirionnydd, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Fuller', 'Affiliation': 'Primary Care and Population Sciences, University of Southampton, Aldermoor Health Centre, Southampton, UK.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Hobbs', 'Affiliation': 'Clinical Trials Unit, Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.'}, {'ForeName': 'Kerenza', 'Initials': 'K', 'LastName': 'Hood', 'Affiliation': 'Centre for Trials Research, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Mandy', 'Initials': 'M', 'LastName': 'Lau', 'Affiliation': 'Centre for Trials Research, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Little', 'Affiliation': 'Primary Care and Population Sciences, University of Southampton, Aldermoor Health Centre, Southampton, UK.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Moore', 'Affiliation': 'Primary Care and Population Sciences, University of Southampton, Aldermoor Health Centre, Southampton, UK.'}, {'ForeName': 'Victoria', 'Initials': 'V', 'LastName': 'Shepherd', 'Affiliation': 'Division of Population Medicine, School of Medicine, Neuadd Meirionnydd, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Stanton', 'Affiliation': 'Centre for Trials Research, Cardiff University, Cardiff, UK.'}, {'ForeName': 'Alun', 'Initials': 'A', 'LastName': 'Toghill', 'Affiliation': 'Lay Representative, Cardiff, UK.'}, {'ForeName': 'Mandy', 'Initials': 'M', 'LastName': 'Wootton', 'Affiliation': 'Specialist Antimicrobial Chemotherapy Unit, Public Health Wales Microbiology Cardiff, University Hospital of Wales, Cardiff, UK.'}, {'ForeName': 'Chris C', 'Initials': 'CC', 'LastName': 'Butler', 'Affiliation': 'Clinical Trials Unit, Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK.'}]",BMJ open,['10.1136/bmjopen-2018-027513'] 3282,32149427,Aromatic L-Amino Acid Decarboxylase Gene Therapy Enhances Levodopa Response in Parkinson's Disease.,"BACKGROUND As Parkinson's disease progresses, levodopa treatment loses efficacy, partly through the loss of the endogenous dopamine-synthesizing enzyme L-amino acid decarboxylase (AADC). In the phase I PD-1101 study, putaminal administration of VY-AADC01, an investigational adeno-associated virus serotype-2 vector for delivery of the AADC gene in patients with advanced Parkinson's disease, was well tolerated, improved motor function, and reduced antiparkinsonian medication requirements. OBJECTIVES This substudy aimed to determine whether the timing and magnitude of motor response to intravenous levodopa changed in PD-1101 patients after VY-AADC01 administration. METHODS Participants received 2-hour threshold (0.6 mg/kg/h) and suprathreshold (1.2 mg/kg/h) levodopa infusions on each of 2 days, both before and approximately 6 months after VY-AADC01. Infusion order was randomized and double blinded. Unified Parkinson's Disease Rating Scale motor scores, finger-tapping speeds, and dyskinesia rating scores were assessed every 30 minutes for 1 hour before and ≥3 hours after start of levodopa infusion. RESULTS Of 15 PD-1101 patients, 13 participated in the substudy. Unified Parkinson's Disease Rating Scale motor score area under the curve responses to threshold and suprathreshold levodopa infusions increased by 168% and 67%, respectively, after VY-AADC01; finger-tapping speeds improved by 162% and 113%, and dyskinesia scores increased by 208% and 72%, respectively, after VY-AADC01. Adverse events (mild/moderate severity) were reported in 5 participants during levodopa infusions pre-VY-AADC01 and 2 participants post-VY-AADC01 administration. CONCLUSIONS VY-AADC01 improved motor responses to intravenous levodopa given under controlled conditions. These data and findings from the parent study support further clinical development of AADC gene therapy for people with Parkinson's disease. © 2020 The Authors. Movement Disorders published by Wiley Periodicals, Inc. on behalf of International Parkinson and Movement Disorder Society.",2020,"Unified Parkinson's Disease Rating Scale motor score area under the curve responses to threshold and suprathreshold levodopa infusions increased by 168% and 67%, respectively, after VY-AADC01; finger-tapping speeds improved by 162% and 113%, and dyskinesia scores increased by 208% and 72%, respectively, after VY-AADC01.","['2020', ""patients with advanced Parkinson's disease"", ""people with Parkinson's disease"", 'PD-1101 patients after VY-AADC01 administration', ""Parkinson's Disease"", 'Of 15 PD-1101 patients, 13 participated in the substudy']","['levodopa', 'Aromatic L-Amino Acid Decarboxylase Gene Therapy', 'levodopa infusions']","['dyskinesia scores', 'Adverse events', 'tapping speeds', 'Levodopa Response', ""Unified Parkinson's Disease Rating Scale motor score area under the curve responses to threshold and suprathreshold levodopa infusions"", 'motor responses', ""Unified Parkinson's Disease Rating Scale motor scores, finger-tapping speeds, and dyskinesia rating scores""]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0030567', 'cui_str': 'Idiopathic Parkinson Disease'}, {'cui': 'C1533734', 'cui_str': 'Administration'}]","[{'cui': 'C0023570', 'cui_str': 'Levodopa'}, {'cui': 'C1412028', 'cui_str': '5-Hydroxytryptophan Decarboxylase'}, {'cui': 'C0017296', 'cui_str': 'Gene therapy (procedure)'}]","[{'cui': 'C1869094', 'cui_str': 'Dyskinesia (SMQ)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0034115', 'cui_str': 'Puncture and Drainage'}, {'cui': 'C0023570', 'cui_str': 'Levodopa'}, {'cui': 'C0030567', 'cui_str': 'Idiopathic Parkinson Disease'}, {'cui': 'C0222045'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C0449864', 'cui_str': 'Threshold (property) (qualifier value)'}, {'cui': 'C0574032', 'cui_str': 'Infusion - action (qualifier value)'}, {'cui': 'C1285623', 'cui_str': 'Motor response'}, {'cui': 'C0016129', 'cui_str': 'Fingers'}]",,0.114359,"Unified Parkinson's Disease Rating Scale motor score area under the curve responses to threshold and suprathreshold levodopa infusions increased by 168% and 67%, respectively, after VY-AADC01; finger-tapping speeds improved by 162% and 113%, and dyskinesia scores increased by 208% and 72%, respectively, after VY-AADC01.","[{'ForeName': 'John G', 'Initials': 'JG', 'LastName': 'Nutt', 'Affiliation': 'Department of Neurology, Oregon Health & Science University, Portland, Oregon, USA.'}, {'ForeName': 'Carolin', 'Initials': 'C', 'LastName': 'Curtze', 'Affiliation': 'Department of Biomechanics, University of Nebraska at Omaha, Omaha, Nebraska, USA.'}, {'ForeName': 'Amie', 'Initials': 'A', 'LastName': 'Hiller', 'Affiliation': 'Department of Neurology, Oregon Health & Science University, Portland, Oregon, USA.'}, {'ForeName': 'Shannon', 'Initials': 'S', 'LastName': 'Anderson', 'Affiliation': 'Department of Neurology, Oregon Health & Science University, Portland, Oregon, USA.'}, {'ForeName': 'Paul S', 'Initials': 'PS', 'LastName': 'Larson', 'Affiliation': 'Department of Neurological Surgery, University of California San Francisco, San Francisco, California, USA.'}, {'ForeName': 'Amber D', 'Initials': 'AD', 'LastName': 'Van Laar', 'Affiliation': 'Department of Neurology, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'R Mark', 'Initials': 'RM', 'LastName': 'Richardson', 'Affiliation': 'Department of Neurological Surgery, University of Pittsburgh, Pittsburgh, Pennsylvania, USA.'}, {'ForeName': 'Marin E', 'Initials': 'ME', 'LastName': 'Thompson', 'Affiliation': 'Department of Neurological Surgery, University of California San Francisco, San Francisco, California, USA.'}, {'ForeName': 'Alexander', 'Initials': 'A', 'LastName': 'Sedkov', 'Affiliation': 'Voyager Therapeutics, Inc., Cambridge, Massachusetts, USA.'}, {'ForeName': 'Mika', 'Initials': 'M', 'LastName': 'Leinonen', 'Affiliation': 'Clinical Data Science GmbH, Basel, Switzerland.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Ravina', 'Affiliation': 'Voyager Therapeutics, Inc., Cambridge, Massachusetts, USA.'}, {'ForeName': 'Krystof S', 'Initials': 'KS', 'LastName': 'Bankiewicz', 'Affiliation': 'Department of Neurological Surgery, University of California San Francisco, San Francisco, California, USA.'}, {'ForeName': 'Chadwick W', 'Initials': 'CW', 'LastName': 'Christine', 'Affiliation': 'Department of Neurology, University of California San Francisco, San Francisco, California, USA.'}]",Movement disorders : official journal of the Movement Disorder Society,['10.1002/mds.27993'] 3283,32149456,Effects of Group-Based Exercise on Flourishing and Stigma Consciousness among Older Adults: Findings from a Randomised Controlled Trial.,"BACKGROUND To examine the extent to which group-based exercise programs, informed by self-categorisation theory, result in improvements in psychological flourishing and reductions in age- and gender-related stigma consciousness among older adults. METHODS In the study, older adults (N = 485, ≥ 65 years) were randomised to similar age same gender (SASG), similar age mixed gender (SAMG), or ""standard"" mixed age mixed gender (MAMG) group-based exercise programs. Flourishing and stigma consciousness were assessed on six occasions during the 24-week intervention and represented secondary trial outcomes. Multilevel growth models examined the effects of the interventions on flourishing and stigma consciousness over time. RESULTS Participants in the SASG and SAMG conditions demonstrated, on average, higher levels of flourishing, relative to the MAMG condition, over the course of the 24 weeks (p < .05). Additionally, participants demonstrated lower levels of age- and gender-related stigma consciousness in both the SASG and SAMG conditions relative to the MAMG condition (p < .05). No time by group interaction effects were observed for either flourishing or stigma consciousness. CONCLUSIONS The results provide some support for the utility of group exercise programs, informed by self-categorisation theory, to enhance psychological flourishing and reduce stigma consciousness among older adults.",2020,"Additionally, participants demonstrated lower levels of age- and gender-related stigma consciousness in both the SASG and SAMG conditions relative to the MAMG condition (p < .05).","['older adults (N\xa0=\xa0485, ≥ 65\xa0years', 'Older Adults', 'older adults']","['standard"" mixed age mixed gender (MAMG) group-based exercise programs', 'Group-Based Exercise']","['flourishing or stigma consciousness', 'Flourishing and stigma consciousness', 'Flourishing and Stigma Consciousness', 'stigma consciousness', 'flourishing and stigma consciousness', 'lower levels of age- and gender-related stigma consciousness']","[{'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0277787', 'cui_str': 'Stigma (finding)'}, {'cui': 'C0234421', 'cui_str': 'Consciousness'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0079399', 'cui_str': 'Gender'}]",,0.0385621,"Additionally, participants demonstrated lower levels of age- and gender-related stigma consciousness in both the SASG and SAMG conditions relative to the MAMG condition (p < .05).","[{'ForeName': 'Geralyn R', 'Initials': 'GR', 'LastName': 'Ruissen', 'Affiliation': 'University of British Columbia, Vancouver, Canada.'}, {'ForeName': 'Yan', 'Initials': 'Y', 'LastName': 'Liu', 'Affiliation': 'University of British Columbia, Vancouver, Canada.'}, {'ForeName': 'Toni', 'Initials': 'T', 'LastName': 'Schmader', 'Affiliation': 'University of British Columbia, Vancouver, Canada.'}, {'ForeName': 'David R', 'Initials': 'DR', 'LastName': 'Lubans', 'Affiliation': 'University of Newcastle, Callaghan, Australia.'}, {'ForeName': 'Samantha M', 'Initials': 'SM', 'LastName': 'Harden', 'Affiliation': 'Virginia Tech, Blacksburg, VA, USA.'}, {'ForeName': 'Svenja A', 'Initials': 'SA', 'LastName': 'Wolf', 'Affiliation': 'University of Amsterdam, Amsterdam, The Netherlands.'}, {'ForeName': 'Ryan E', 'Initials': 'RE', 'LastName': 'Rhodes', 'Affiliation': 'University of Victoria, Victoria, Canada.'}, {'ForeName': 'William L', 'Initials': 'WL', 'LastName': 'Dunlop', 'Affiliation': 'University of California, Riverside, CA, USA.'}, {'ForeName': 'Eli', 'Initials': 'E', 'LastName': 'Puterman', 'Affiliation': 'University of British Columbia, Vancouver, Canada.'}, {'ForeName': 'Bruno D', 'Initials': 'BD', 'LastName': 'Zumbo', 'Affiliation': 'University of British Columbia, Vancouver, Canada.'}, {'ForeName': 'Mark R', 'Initials': 'MR', 'LastName': 'Beauchamp', 'Affiliation': 'University of British Columbia, Vancouver, Canada.'}]",Applied psychology. Health and well-being,['10.1111/aphw.12197'] 3284,31691827,Long-term study of the safety and maintenance of efficacy of solriamfetol (JZP-110) in the treatment of excessive sleepiness in participants with narcolepsy or obstructive sleep apnea.,"STUDY OBJECTIVES To evaluate long-term safety and maintenance of efficacy of solriamfetol treatment for excessive daytime sleepiness in narcolepsy and obstructive sleep apnea (OSA). METHODS Participants with narcolepsy or OSA who completed a prior solriamfetol study were eligible. A 2-week titration period was followed by a maintenance phase (up to 50 weeks). Efficacy was assessed by Epworth Sleepiness Scale (ESS) and Patient and Clinical Global Impression of Change (PGI-C and CGI-C, respectively). After approximately 6 months of treatment, a subgroup entered a 2-week placebo-controlled randomized withdrawal (RW) phase. Change in ESS from beginning to end of the RW phase was the primary endpoint; PGI-C and CGI-C were secondary endpoints. Safety was assessed throughout the study. RESULTS In the maintenance phase, solriamfetol-treated participants demonstrated clinically meaningful improvements on ESS, PGI-C, and CGI-C. In the RW phase, least squares mean change on ESS was 1.6 in participants continuing solriamfetol versus 5.3 in participants switched to placebo (p < .0001). For both secondary endpoints, higher percentages of participants receiving placebo were reported as worse at the end of the RW phase versus solriamfetol (p < .0001). Common treatment-emergent adverse events (TEAEs) with solriamfetol were headache, nausea, nasopharyngitis, insomnia, dry mouth, anxiety, decreased appetite, and upper respiratory tract infection; 27 (4.2%) participants experienced at least one serious TEAE, and 61 (9.5%) withdrew because of TEAEs. CONCLUSIONS This study demonstrated long-term maintenance of efficacy of solriamfetol under open-label and double-blind, placebo-controlled conditions. Safety profile of solriamfetol was consistent with previous 12-week studies; no new safety concerns were identified. TRIAL REGISTRATION NCT02348632.",2020,"Safety profile of solriamfetol was consistent with previous 12-week studies; no new safety concerns were identified. ","['excessive daytime sleepiness in narcolepsy and obstructive sleep apnea (OSA', 'Participants with narcolepsy or OSA who completed a prior solriamfetol study were eligible', 'participants with narcolepsy or obstructive sleep apnea']","['placebo', 'solriamfetol under open-label and double-blind, placebo', 'solriamfetol (JZP-110', 'solriamfetol treatment']","['ESS', 'Safety', 'excessive sleepiness', 'Epworth Sleepiness Scale (ESS) and Patient and Clinical Global Impression of Change (PGI-C and CGI-C, respectively', 'Efficacy', 'ESS, PGI-C, and CGI-C', 'headache, nausea, nasopharyngitis, insomnia, dry mouth, anxiety, decreased appetite, and upper respiratory tract infection']","[{'cui': 'C4551761', 'cui_str': 'Excessive daytime sleepiness'}, {'cui': 'C0027404', 'cui_str': 'Narcoleptic Syndrome'}, {'cui': 'C0520679', 'cui_str': 'Syndrome, Sleep Apnea, Obstructive'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0175566', 'cui_str': 'Patent (qualifier value)'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0456909', 'cui_str': 'Blindness'}, {'cui': 'C4547387', 'cui_str': 'JZP-110'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0917799', 'cui_str': 'Hypersomnia'}, {'cui': 'C3541276', 'cui_str': 'ESS - Epworth Sleepiness Scale'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0027497', 'cui_str': 'Nausea'}, {'cui': 'C0027441', 'cui_str': 'Nasopharyngitis'}, {'cui': 'C0917801', 'cui_str': 'Sleeplessness'}, {'cui': 'C0043352', 'cui_str': 'Mouth Dryness'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0232462', 'cui_str': 'Decrease in appetite (finding)'}, {'cui': 'C0041912', 'cui_str': 'Upper Respiratory Infections'}]",,0.151496,"Safety profile of solriamfetol was consistent with previous 12-week studies; no new safety concerns were identified. ","[{'ForeName': 'Atul', 'Initials': 'A', 'LastName': 'Malhotra', 'Affiliation': 'Division of Pulmonary, Critical Care and Sleep Medicine, University of California San Diego, La Jolla.'}, {'ForeName': 'Colin', 'Initials': 'C', 'LastName': 'Shapiro', 'Affiliation': 'University of Toronto, ON, Canada.'}, {'ForeName': 'Jean-Louis', 'Initials': 'JL', 'LastName': 'Pepin', 'Affiliation': 'HP2 Laboratory, INSERM U1042, University Grenoble Alpes, France.'}, {'ForeName': 'Jan', 'Initials': 'J', 'LastName': 'Hedner', 'Affiliation': 'Sahlgrenska University Hospital, Gothenburg University, Sweden.'}, {'ForeName': 'Mansoor', 'Initials': 'M', 'LastName': 'Ahmed', 'Affiliation': 'Cleveland Sleep Research Center, OH.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Foldvary-Schaefer', 'Affiliation': 'Cleveland Clinic Lerner College of Medicine, OH.'}, {'ForeName': 'Patrick J', 'Initials': 'PJ', 'LastName': 'Strollo', 'Affiliation': 'University of Pittsburgh/Veterans Administration Pittsburgh Health System, PA.'}, {'ForeName': 'Geert', 'Initials': 'G', 'LastName': 'Mayer', 'Affiliation': 'Hephata Klinik, Schwalmstadt, Germany.'}, {'ForeName': 'Kathleen', 'Initials': 'K', 'LastName': 'Sarmiento', 'Affiliation': 'San Francisco Veterans Administration Healthcare System, CA.'}, {'ForeName': 'Michelle', 'Initials': 'M', 'LastName': 'Baladi', 'Affiliation': 'Jazz Pharmaceuticals, Palo Alto, CA.'}, {'ForeName': 'Patricia', 'Initials': 'P', 'LastName': 'Chandler', 'Affiliation': 'Jazz Pharmaceuticals, Palo Alto, CA.'}, {'ForeName': 'Lawrence', 'Initials': 'L', 'LastName': 'Lee', 'Affiliation': 'Jazz Pharmaceuticals, Palo Alto, CA.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Schwab', 'Affiliation': 'University of Pennsylvania, Philadelphia.'}]",Sleep,['10.1093/sleep/zsz220'] 3285,31230026,Randomised controlled trial (RCT) study design for a large-scale municipal fall prevention exercise programme in community-living older women: study protocol for the Kuopio Fall Prevention Study (KFPS).,"INTRODUCTION Falls are a substantial health problem in seniors, causing fractures and being the leading cause of fatal injuries. The benefits of physical activity in fall prevention have been shown in randomised controlled trials (RCTs) in small cohorts (eg, ≤200 persons), but there is a gap between the known health effects of exercise and the large-scale implementation of effective activity in communities. Mental health and subjective well-being (SWB) should also be studied since they are strongly related to healthy ageing. Thus far, the proven efficacy of communal strategies to reduce falls and improve healthy ageing is sparse. METHODS AND ANALYSIS In 2016, a 2-year RCT was launched in Kuopio, Finland to estimate the efficacy of a large, population-based, fall prevention exercise programme in community-living older women (born 1932-1945). Both the intervention and control group (n=457+457) receive health education. The intervention group is also offered free 6-month supervised training courses (weekly gym training and Taiji sessions), followed by a free 6-month unsupervised use of exercise facilities, as well as unsupervised low-cost exercise is also offered for another 12 months. During the whole 24-month follow-up, controls are free to pursue all their normal physical activities. Both study groups undergo the study measurements three times. Outcome measures include recording of falls, injuries, bone mineral density, changes in health and functional status and cognitive performance, deaths and SWB. Finally, the cost-effectiveness and cost-utility analysis will be conducted from the societal view. The main analyses comparing outcomes between study groups will be conducted using the intention to treat principle. ETHICS AND DISSEMINATION The study has been reviewed and approved by the Research Ethics Committee of the Hospital District of North Savo. All regulations and measures of ethics and confidentiality are handled in accordance with the Declaration of Helsinki. TRIAL REGISTRATION NUMBER NCT02665169; Pre-results.",2019,Mental health and subjective well-being (SWB) should also be studied since they are strongly related to healthy ageing.,"['community-living older women (born 1932-1945', 'Hospital District of North Savo', 'community-living older women', 'small cohorts (eg, ≤200 persons']","['supervised training courses (weekly gym training and Taiji sessions), followed by a free 6-month unsupervised use of exercise facilities, as well as unsupervised low-cost exercise', 'large-scale municipal fall prevention exercise programme', 'health education']","['recording of falls, injuries, bone mineral density, changes in health and functional status and cognitive performance, deaths and SWB', 'cost-effectiveness and cost-utility analysis', 'Mental health and subjective well-being (SWB']","[{'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0004897', 'cui_str': 'Ursidae'}, {'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C0027361', 'cui_str': 'Persons'}]","[{'cui': 'C0220931', 'cui_str': 'Functional training'}, {'cui': 'C0750729', 'cui_str': 'Courses (qualifier value)'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C0376403', 'cui_str': 'Taiji'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C1524063', 'cui_str': 'Use of (attribute)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0222045'}, {'cui': 'C0150223', 'cui_str': 'Fall prevention (procedure)'}, {'cui': 'C0018701'}]","[{'cui': 'C0000921', 'cui_str': 'Falls'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C0005938', 'cui_str': 'Bone Mineral Density'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0205245', 'cui_str': 'Functional (qualifier value)'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}, {'cui': 'C3853052', 'cui_str': 'Cost-Utility Analysis'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}]",,0.0345227,Mental health and subjective well-being (SWB) should also be studied since they are strongly related to healthy ageing.,"[{'ForeName': 'Tommi', 'Initials': 'T', 'LastName': 'Vilpunaho', 'Affiliation': 'Kuopio Musculoskeletal Research Unit (KMRU), University of Eastern Finland - Kuopio Campus, Finland.'}, {'ForeName': 'Heikki', 'Initials': 'H', 'LastName': 'Kröger', 'Affiliation': 'Kuopio Musculoskeletal Research Unit (KMRU), University of Eastern Finland - Kuopio Campus, Finland.'}, {'ForeName': 'Risto', 'Initials': 'R', 'LastName': 'Honkanen', 'Affiliation': 'Kuopio Musculoskeletal Research Unit (KMRU), University of Eastern Finland - Kuopio Campus, Finland.'}, {'ForeName': 'Heli', 'Initials': 'H', 'LastName': 'Koivumaa-Honkanen', 'Affiliation': 'Institute of Clinical Medicine (Psychiatry), University of Eastern Finland - Kuopio Campus, Finland.'}, {'ForeName': 'Joonas', 'Initials': 'J', 'LastName': 'Sirola', 'Affiliation': 'Kuopio Musculoskeletal Research Unit (KMRU), University of Eastern Finland - Kuopio Campus, Finland.'}, {'ForeName': 'Virpi', 'Initials': 'V', 'LastName': 'Kuvaja-Köllner', 'Affiliation': 'Department of Health and Social Management, University of Eastern Finland - Kuopio Campus, Finland.'}, {'ForeName': 'Reijo', 'Initials': 'R', 'LastName': 'Sund', 'Affiliation': 'Kuopio Musculoskeletal Research Unit (KMRU), University of Eastern Finland - Kuopio Campus, Finland.'}, {'ForeName': 'Toni', 'Initials': 'T', 'LastName': 'Rikkonen', 'Affiliation': 'Kuopio Musculoskeletal Research Unit (KMRU), University of Eastern Finland - Kuopio Campus, Finland.'}]",BMJ open,['10.1136/bmjopen-2018-028716'] 3286,31192894,Baseline Characteristics Explain Differences in Effectiveness of Randomization to Daily Oral TDF/FTC PrEP Between Transgender Women and Cisgender Men Who Have Sex With Men in the iPrEx Trial.,,2019,,"['Who Have Sex With Men in the iPrEx Trial', 'Transgender Women and Cisgender Men']",['Daily Oral TDF/FTC PrEP'],[],"[{'cui': 'C1314687', 'cui_str': 'Sexual intercourse - finding'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C1319927', 'cui_str': 'Male-to-female transsexual'}]","[{'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}]",[],,0.166732,,"[{'ForeName': 'Megha L', 'Initials': 'ML', 'LastName': 'Mehrotra', 'Affiliation': 'University of California, San Francisco, San Francisco, CA.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Westreich', 'Affiliation': 'University of North Carolina, Chapel Hill, NC.'}, {'ForeName': 'Vanessa M', 'Initials': 'VM', 'LastName': 'McMahan', 'Affiliation': 'University of Washington, Seattle, WA.'}, {'ForeName': 'Medellena Maria', 'Initials': 'MM', 'LastName': 'Glymour', 'Affiliation': 'University of California, San Francisco, San Francisco, CA.'}, {'ForeName': 'Elvin', 'Initials': 'E', 'LastName': 'Geng', 'Affiliation': 'University of California, San Francisco, San Francisco, CA.'}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'Grant', 'Affiliation': 'University of California, San Francisco, San Francisco, CA.'}, {'ForeName': 'David V', 'Initials': 'DV', 'LastName': 'Glidden', 'Affiliation': 'University of California, San Francisco, San Francisco, CA.'}]",Journal of acquired immune deficiency syndromes (1999),['10.1097/QAI.0000000000002037'] 3287,31152118,Changes in Albuminuria But Not GFR are Associated with Early Changes in Kidney Structure in Type 2 Diabetes.,"BACKGROUND In type 1 diabetes, changes in the GFR and urine albumin-to-creatinine ratio (ACR) are related to changes in kidney structure that reflect disease progression. However, such changes have not been studied in type 2 diabetes. METHODS Participants were American Indians with type 2 diabetes enrolled in a clinical trial of losartan versus placebo. We followed a subset who underwent kidney biopsy at the end of the 6-year trial, with annual measurements of GFR (by urinary clearance of iothalamate) and ACR. Participants had a second kidney biopsy after a mean follow-up of 9.3 years. We used quantitative morphometric analyses to evaluate both biopsy specimens. RESULTS Baseline measures for 48 participants (12 men and 36 women, mean age 45.6 years) who completed the study included diabetes duration (14.6 years), GFR (156 ml/min), and ACR (15 mg/g). During follow-up, glomerular basement membrane (GBM) width, mesangial fractional volume, and ACR increased, and surface density of peripheral GBM and GFR decreased. After adjustment for sex, age, ACR, and each morphometric variable at baseline, an increase in ACR during follow-up was significantly associated with increases in GBM width, mesangial fractional volume, and mean glomerular volume, and a decrease in surface density of peripheral GBM. Decline in GFR was not associated with changes in these morphometric variables after additionally adjusting for baseline GFR. CONCLUSIONS In American Indians with type 2 diabetes and preserved GFR at baseline, increasing ACR reflects the progression of earlier structural glomerular lesions, whereas early GFR decline may not accurately reflect such lesions.",2019,"During follow-up, glomerular basement membrane (GBM) width, mesangial fractional volume, and ACR increased, and surface density of peripheral GBM and GFR decreased.","['Participants had a second kidney biopsy after a mean follow-up of 9.3 years', '48 participants (12 men and 36 women, mean age 45.6 years) who completed the study included diabetes duration (14.6 years), GFR (156 ml/min), and ACR (15 mg/g', 'Participants were American Indians with type 2 diabetes enrolled in a clinical trial of']",['losartan versus placebo'],"['surface density of peripheral GBM', 'ACR', 'glomerular basement membrane (GBM) width, mesangial fractional volume, and ACR increased, and surface density of peripheral GBM and GFR', 'GBM width, mesangial fractional volume, and mean glomerular volume', 'Albuminuria']","[{'cui': 'C0457385', 'cui_str': 'Seconds (qualifier value)'}, {'cui': 'C0194073', 'cui_str': 'Kidney biopsy (procedure)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C0017654', 'cui_str': 'Glomerular Filtration Rate'}, {'cui': 'C0439445', 'cui_str': 'mL/min'}, {'cui': 'C1300563', 'cui_str': 'ug/mg'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0011849', 'cui_str': 'Diabetes Mellitus'}, {'cui': 'C0008976', 'cui_str': 'Clinical Trials as Topic'}]","[{'cui': 'C0126174', 'cui_str': 'Losartan'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0205148', 'cui_str': 'Surface (attribute)'}, {'cui': 'C0178587', 'cui_str': 'Mass to volume ratio'}, {'cui': 'C0205100', 'cui_str': 'Peripheral (qualifier value)'}, {'cui': 'C0599297', 'cui_str': 'Glomerular Basement Membrane'}, {'cui': 'C0487742', 'cui_str': 'Width (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0205217', 'cui_str': 'Increased (qualifier value)'}, {'cui': 'C0017654', 'cui_str': 'Glomerular Filtration Rate'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001925', 'cui_str': 'Albuminuria'}]",,0.0432994,"During follow-up, glomerular basement membrane (GBM) width, mesangial fractional volume, and ACR increased, and surface density of peripheral GBM and GFR decreased.","[{'ForeName': 'Helen C', 'Initials': 'HC', 'LastName': 'Looker', 'Affiliation': 'Chronic Kidney Disease Section, National Institute of Diabetes and Digestive and Kidney Diseases, Phoenix, Arizona; helen.looker@nih.gov.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Mauer', 'Affiliation': 'Department of Pediatrics and Medicine, University of Minnesota, Minneapolis, Minnesota.'}, {'ForeName': 'Pierre-Jean', 'Initials': 'PJ', 'LastName': 'Saulnier', 'Affiliation': 'Chronic Kidney Disease Section, National Institute of Diabetes and Digestive and Kidney Diseases, Phoenix, Arizona.'}, {'ForeName': 'Jennifer L', 'Initials': 'JL', 'LastName': 'Harder', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Viji', 'Initials': 'V', 'LastName': 'Nair', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Carine M', 'Initials': 'CM', 'LastName': 'Boustany-Kari', 'Affiliation': 'Cardiometabolic Diseases Research, Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, Connecticut.'}, {'ForeName': 'Paolo', 'Initials': 'P', 'LastName': 'Guarnieri', 'Affiliation': 'Cardiometabolic Diseases Research, Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, Connecticut.'}, {'ForeName': 'Jon', 'Initials': 'J', 'LastName': 'Hill', 'Affiliation': 'Cardiometabolic Diseases Research, Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, Connecticut.'}, {'ForeName': 'Cordell A', 'Initials': 'CA', 'LastName': 'Esplin', 'Affiliation': ""Department of Radiology, St Luke's Medical Center, Phoenix, Arizona; and.""}, {'ForeName': 'Matthias', 'Initials': 'M', 'LastName': 'Kretzler', 'Affiliation': 'Division of Nephrology, Department of Internal Medicine, University of Michigan, Ann Arbor, Michigan.'}, {'ForeName': 'Robert G', 'Initials': 'RG', 'LastName': 'Nelson', 'Affiliation': 'Chronic Kidney Disease Section, National Institute of Diabetes and Digestive and Kidney Diseases, Phoenix, Arizona.'}, {'ForeName': 'Behzad', 'Initials': 'B', 'LastName': 'Najafian', 'Affiliation': 'Department of Pathology, University of Washington, Seattle, Washington.'}]",Journal of the American Society of Nephrology : JASN,['10.1681/ASN.2018111166'] 3288,30597768,Safety and Tolerability of Omalizumab: A Randomized Clinical Trial of Humanized Anti-IgE Monoclonal Antibody in Systemic Lupus Erythematosus.,"OBJECTIVE Autoreactive IgE antibodies have been implicated in the pathogenesis of systemic lupus erythematosus (SLE). We hypothesize that omalizumab, a monoclonal antibody binding IgE, may improve SLE activity by reducing type I interferon (IFN) production by hampering plasmacytoid dendritic cells and basophil activation. This study was undertaken to assess the safety, tolerability, and clinical efficacy of omalizumab in mild to moderate SLE. METHODS Sixteen subjects with SLE and a Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score of ≥4 and elevated autoreactive IgE antibody levels were randomized to receive omalizumab or placebo (2:1) for 16 weeks, followed by 16 weeks of open-label treatment and a 4-week washout period. The SLEDAI-2K score, British Isles Lupus Assessment Group index (BILAG 2004) score, and physician's global assessment of disease activity were recorded at each visit. The type I IFN-induced gene signature was determined using quantitative polymerase chain reaction. RESULTS Omalizumab was well tolerated with no allergic reactions, and mostly mild adverse events comparable to those experienced with placebo treatment. SLEDAI-2K scores improved in the omalizumab group compared to the placebo group at week 16 (P = 0.038), as well as during the open-label phase in subjects initially receiving placebo (P = 0.02). No worsening in BILAG scores or the physician's global assessment was detected. There was a trend toward a reduction in IFN gene signature in subjects treated with omalizumab (P = 0.11), especially in subjects with a high baseline IFN signature (P = 0.052). CONCLUSION Our findings indicate that omalizumab is well tolerated in SLE and is associated with improvement in disease activity. Larger randomized clinical trials will be needed to assess the efficacy of omalizumab in patients with SLE.",2019,"SLEDAI-2K scores improved in the omalizumab group compared to the placebo group at week 16 (P = 0.038), as well as during the open-label phase in subjects initially receiving placebo (P = 0.02).","['Systemic Lupus Erythematosus', 'Sixteen subjects with SLE and a Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score of ≥4 and elevated autoreactive IgE antibody levels', 'patients with SLE', 'mild to moderate SLE']","['Humanized Anti-IgE Monoclonal Antibody', 'placebo', 'Omalizumab', 'omalizumab', 'omalizumab or placebo']","['tolerated with no allergic reactions', 'Safety and Tolerability', 'SLEDAI-2K scores', 'BILAG scores', 'safety, tolerability', ""SLEDAI-2K score, British Isles Lupus Assessment Group index (BILAG 2004) score, and physician's global assessment of disease activity"", 'IFN gene signature', 'disease activity']","[{'cui': 'C0024141', 'cui_str': 'Lupus Erythematosus Disseminatus'}, {'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C1141000', 'cui_str': 'Sled, device (physical object)'}, {'cui': 'C0451528', 'cui_str': 'Systemic lupus erythematosus disease activity index (assessment scale)'}, {'cui': 'C0470277', 'cui_str': '2000'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0202086', 'cui_str': 'Immunoglobulin E measurement (procedure)'}, {'cui': 'C0003241', 'cui_str': 'Antibodies'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}]","[{'cui': 'C0051978', 'cui_str': 'anti-IgE antibodies'}, {'cui': 'C3542957', 'cui_str': 'Antineoplastic MAbs'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0966225', 'cui_str': 'omalizumab'}]","[{'cui': 'C1527304', 'cui_str': 'Allergic Reaction'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0409974', 'cui_str': 'Lupus erythematosus (disorder)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C0017337', 'cui_str': 'Genes'}]",16.0,0.138369,"SLEDAI-2K scores improved in the omalizumab group compared to the placebo group at week 16 (P = 0.038), as well as during the open-label phase in subjects initially receiving placebo (P = 0.02).","[{'ForeName': 'Sarfaraz', 'Initials': 'S', 'LastName': 'Hasni', 'Affiliation': ''}, {'ForeName': 'Sarthak', 'Initials': 'S', 'LastName': 'Gupta', 'Affiliation': ''}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Davis', 'Affiliation': ''}, {'ForeName': 'Elaine', 'Initials': 'E', 'LastName': 'Poncio', 'Affiliation': ''}, {'ForeName': 'Yenealem', 'Initials': 'Y', 'LastName': 'Temesgen-Oyelakin', 'Affiliation': ''}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Joyal', 'Affiliation': ''}, {'ForeName': 'Alice', 'Initials': 'A', 'LastName': 'Fike', 'Affiliation': ''}, {'ForeName': 'Zerai', 'Initials': 'Z', 'LastName': 'Manna', 'Affiliation': ''}, {'ForeName': 'Sungyoung', 'Initials': 'S', 'LastName': 'Auh', 'Affiliation': 'National Institute of Diabetes and Digestive and Kidney Diseases, NIH, Bethesda, Maryland.'}, {'ForeName': 'Yinghui', 'Initials': 'Y', 'LastName': 'Shi', 'Affiliation': ''}, {'ForeName': 'Diana', 'Initials': 'D', 'LastName': 'Chan', 'Affiliation': ''}, {'ForeName': 'Philip', 'Initials': 'P', 'LastName': 'Carlucci', 'Affiliation': ''}, {'ForeName': 'Ann', 'Initials': 'A', 'LastName': 'Biehl', 'Affiliation': 'Clinical Center, NIH, Bethesda, Maryland.'}, {'ForeName': 'Barbara', 'Initials': 'B', 'LastName': 'Dema', 'Affiliation': ''}, {'ForeName': 'Nicolas', 'Initials': 'N', 'LastName': 'Charles', 'Affiliation': ''}, {'ForeName': 'James E', 'Initials': 'JE', 'LastName': 'Balow', 'Affiliation': 'National Institute of Diabetes and Digestive and Kidney Diseases, NIH, Bethesda, Maryland.'}, {'ForeName': 'Meryl', 'Initials': 'M', 'LastName': 'Waldman', 'Affiliation': 'National Institute of Diabetes and Digestive and Kidney Diseases, NIH, Bethesda, Maryland.'}, {'ForeName': 'Richard M', 'Initials': 'RM', 'LastName': 'Siegel', 'Affiliation': ''}, {'ForeName': 'Mariana J', 'Initials': 'MJ', 'LastName': 'Kaplan', 'Affiliation': 'National Institute of Arthritis and Musculoskeletal and Skin Diseases, NIH, Bethesda, Maryland.'}, {'ForeName': 'Juan', 'Initials': 'J', 'LastName': 'Rivera', 'Affiliation': 'National Institute of Arthritis and Musculoskeletal and Skin Diseases, NIH, Bethesda, Maryland.'}]","Arthritis & rheumatology (Hoboken, N.J.)",['10.1002/art.40828'] 3289,31326135,The clinical and cost-effectiveness of total versus partial knee replacement in patients with medial compartment osteoarthritis (TOPKAT): 5-year outcomes of a randomised controlled trial.,"BACKGROUND Late-stage isolated medial knee osteoarthritis can be treated with total knee replacement (TKR) or partial knee replacement (PKR). There is high variation in treatment choice and little robust evidence to guide selection. The Total or Partial Knee Arthroplasty Trial (TOPKAT) therefore aims to assess the clinical effectiveness and cost-effectiveness of TKR versus PKR in patients with medial compartment osteoarthritis of the knee, and this represents an analysis of the main endpoints at 5 years. METHODS Our multicentre, pragmatic randomised controlled trial was done at 27 UK sites. We used a combined expertise-based and equipoise-based approach, in which patients with isolated osteoarthritis of the medial compartment of the knee and who satisfied general requirements for a medial PKR were randomly assigned (1:1) to receive PKR or TKR by surgeons who were either expert in and willing to perform both surgeries or by a surgeon with particular expertise in the allocated procedure. The primary endpoint was the Oxford Knee Score (OKS) 5 years after randomisation in all patients assigned to groups. Health-care costs (in UK 2017 prices) and cost-effectiveness were also assessed. This trial is registered with ISRCTN (ISRCTN03013488) and ClinicalTrials.gov (NCT01352247). FINDINGS Between Jan 18, 2010, and Sept 30, 2013, we assessed 962 patients for their eligibility, of whom 431 (45%) patients were excluded (121 [13%] patients did not meet the inclusion criteria and 310 [32%] patients declined to participate) and 528 (55%) patients were randomly assigned to groups. 94% of participants responded to the follow-up survey 5 years after their operation. At the 5-year follow-up, we found no difference in OKS between groups (mean difference 1·04, 95% CI -0·42 to 2·50; p=0·159). In our within-trial cost-effectiveness analysis, we found that PKR was more effective (0·240 additional quality-adjusted life-years, 95% CI 0·046 to 0·434) and less expensive (-£910, 95% CI -1503 to -317) than TKR during the 5 years of follow-up. This finding was a result of slightly better outcomes, lower costs of surgery, and lower follow-up health-care costs with PKR than TKR. INTERPRETATION Both TKR and PKR are effective, offer similar clinical outcomes, and result in a similar incidence of re-operations and complications. Based on our clinical findings, and results regarding the lower costs and better cost-effectiveness with PKR during the 5-year study period, we suggest that PKR should be considered the first choice for patients with late-stage isolated medial compartment osteoarthritis. FUNDING National Institute for Health Research Health Technology Assessment Programme.",2019,The primary endpoint was the Oxford Knee Score (OKS) 5 years after randomisation in all patients assigned to groups.,"['patients with medial compartment osteoarthritis (TOPKAT', 'Between Jan 18, 2010, and Sept 30, 2013, we assessed 962 patients for their eligibility, of whom 431 (45', 'patients were excluded (121 [13%] patients did not meet the inclusion criteria and 310 [32%] patients declined to participate) and 528 (55%) patients', 'patients with medial compartment osteoarthritis of the knee', 'patients with late-stage isolated medial compartment osteoarthritis', 'patients with isolated osteoarthritis of the medial compartment of the knee and who satisfied general requirements for a medial PKR']","['TKR versus PKR', 'total knee replacement (TKR) or partial knee replacement (PKR', 'combined expertise-based and equipoise-based approach', 'partial knee replacement', 'PKR or TKR by surgeons who were either expert in and willing to perform both surgeries or by a surgeon with particular expertise in the allocated procedure']","['OKS', 'Health-care costs', 'Oxford Knee Score (OKS', 'cost-effectiveness']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205098', 'cui_str': 'Medial (qualifier value)'}, {'cui': 'C0029408', 'cui_str': 'Arthritis, Degenerative'}, {'cui': 'C0521125', 'cui_str': 'For (qualifier value)'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C1299585', 'cui_str': 'Does not (qualifier value)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C1963703', 'cui_str': 'Knee region structure (body structure)'}, {'cui': 'C1279941', 'cui_str': 'Late stage (qualifier value)'}, {'cui': 'C0205409', 'cui_str': 'Isolated (qualifier value)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}]","[{'cui': 'C0086511', 'cui_str': 'Knee Arthroplasty'}, {'cui': 'C0864243', 'cui_str': 'Partial Knee Replacement'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0702057', 'cui_str': 'Equipoise'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0582175', 'cui_str': 'Surgeon (occupation)'}, {'cui': 'C0600109', 'cui_str': 'Willing (finding)'}, {'cui': 'C0884358', 'cui_str': 'Performed'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0184661', 'cui_str': 'Procedures'}]","[{'cui': 'C0085552', 'cui_str': 'Healthcare Costs'}, {'cui': 'C1997265', 'cui_str': 'Oxford knee score (observable entity)'}, {'cui': 'C0010181', 'cui_str': 'Cost Effectiveness'}]",962.0,0.148873,The primary endpoint was the Oxford Knee Score (OKS) 5 years after randomisation in all patients assigned to groups.,"[{'ForeName': 'David J', 'Initials': 'DJ', 'LastName': 'Beard', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, Botnar Research Centre, University of Oxford, Oxford, UK. Electronic address: david.beard@ndorms.ox.ac.uk.'}, {'ForeName': 'Loretta J', 'Initials': 'LJ', 'LastName': 'Davies', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, Botnar Research Centre, University of Oxford, Oxford, UK.'}, {'ForeName': 'Jonathan A', 'Initials': 'JA', 'LastName': 'Cook', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, Botnar Research Centre, University of Oxford, Oxford, UK; Health Services Research Unit, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'Graeme', 'Initials': 'G', 'LastName': 'MacLennan', 'Affiliation': 'Health Services Research Unit, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Price', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, Botnar Research Centre, University of Oxford, Oxford, UK.'}, {'ForeName': 'Seamus', 'Initials': 'S', 'LastName': 'Kent', 'Affiliation': 'Nuffield Department of Population Health, University of Oxford, Oxford, UK.'}, {'ForeName': 'Jemma', 'Initials': 'J', 'LastName': 'Hudson', 'Affiliation': 'Health Services Research Unit, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Carr', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, Botnar Research Centre, University of Oxford, Oxford, UK.'}, {'ForeName': 'Jose', 'Initials': 'J', 'LastName': 'Leal', 'Affiliation': 'Nuffield Department of Population Health, University of Oxford, Oxford, UK.'}, {'ForeName': 'Helen', 'Initials': 'H', 'LastName': 'Campbell', 'Affiliation': 'Nuffield Department of Population Health, University of Oxford, Oxford, UK.'}, {'ForeName': 'Ray', 'Initials': 'R', 'LastName': 'Fitzpatrick', 'Affiliation': 'Nuffield Department of Population Health, University of Oxford, Oxford, UK.'}, {'ForeName': 'Nigel', 'Initials': 'N', 'LastName': 'Arden', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, Botnar Research Centre, University of Oxford, Oxford, UK.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Murray', 'Affiliation': 'Nuffield Department of Orthopaedics, Rheumatology and Musculoskeletal Sciences, Botnar Research Centre, University of Oxford, Oxford, UK.'}, {'ForeName': 'Marion K', 'Initials': 'MK', 'LastName': 'Campbell', 'Affiliation': 'Health Services Research Unit, University of Aberdeen, Aberdeen, UK.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","Lancet (London, England)",['10.1016/S0140-6736(19)31281-4'] 3290,31258916,Pilot study: an intensive care unit sleep promotion protocol.,"Purpose Disturbances, such as in-room activity and sound, are significant sources of sleep disruption among critically ill patients. These factors are potentially modifiable. We tested the impact of an intensive care unit (ICU) sleep promotion protocol on overnight in-room disturbance. Methods Our protocol restricted non-urgent bedside care from 00:00 to 03:59. Patients were assigned to usual care (n=30) or the sleep protocol (n=26). The primary outcomes were measures of in-room activity, sound and light. These three types of disturbance were compared between arms during a baseline time block (20:00-23:59) and a rest time block (00:00-03:59). We assessed the sleep protocol effect with generalised linear models. Results Usual care and sleep protocol patients had equivalent levels of in-room activity, sound and light during the baseline time block (20:00-23:59). In contrast, during the rest time block (00:00-03:59), the sleep protocol arm had 32% fewer room entries (rate ratio (RR) 0.68, p=0.001) and 9.1 fewer minutes of in-room activity (p=0.0002). Also, the length of time between room entrances increased from 26.4 to 45.8 min (p=0.0004). The sleep protocol arm also had lower sound during the rest time block. Mean A-weighted sound was 2.5 decibels lower (p=0.02), and there were 36% fewer peaks (RR 0.64, p=0.02). Light levels were highly variable and not changed by the sleep protocol. Conclusions Sleep promotion protocols can improve in-room activity and sound. This provides a better sleep opportunity and may, therefore, improve ICU sleep. Trial registration number 1112009428.",2019,"Mean A-weighted sound was 2.5 decibels lower (p=0.02), and there were 36% fewer peaks (RR 0.64, p=0.02).",['critically ill patients'],"['intensive care unit sleep promotion protocol', 'intensive care unit (ICU) sleep promotion protocol', 'sleep protocol', 'usual care']","['measures of in-room activity, sound and light', 'Mean A-weighted sound', 'length of time between room entrances', 'Light levels', 'equivalent levels of in-room activity, sound and light during the baseline time block']","[{'cui': 'C0010340', 'cui_str': 'Critically Ill'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0424522', 'cui_str': 'Asleep (finding)'}, {'cui': 'C0033414', 'cui_str': 'Promotion'}, {'cui': 'C0442711', 'cui_str': 'Protocols (qualifier value)'}]","[{'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0441655', 'cui_str': 'Activity (observable entity)'}, {'cui': 'C1293120', 'cui_str': 'Sounding'}, {'cui': 'C0332264', 'cui_str': 'Light (weight) (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0337095', 'cui_str': 'Entrance (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0205163', 'cui_str': 'Equal (qualifier value)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}]",,0.0436247,"Mean A-weighted sound was 2.5 decibels lower (p=0.02), and there were 36% fewer peaks (RR 0.64, p=0.02).","[{'ForeName': 'Melissa P', 'Initials': 'MP', 'LastName': 'Knauert', 'Affiliation': 'Section of Pulmonary, Critical Care, and Sleep Medicine, Department of Internal Medicine, Yale University School of Medicine, New Haven, Connecticut, USA.'}, {'ForeName': 'Margaret', 'Initials': 'M', 'LastName': 'Pisani', 'Affiliation': 'Section of Pulmonary, Critical Care, and Sleep Medicine, Department of Internal Medicine, Yale University School of Medicine, New Haven, Connecticut, USA.'}, {'ForeName': 'Nancy', 'Initials': 'N', 'LastName': 'Redeker', 'Affiliation': 'Division of Acute Care/Health Systems, Yale School of Nursing, Yale University, New Haven, Connecticut, USA.'}, {'ForeName': 'Terry', 'Initials': 'T', 'LastName': 'Murphy', 'Affiliation': 'Section of Geriatrics, Department of Internal Medicine, Yale University School of Medicine, New Haven, Connecticut, USA.'}, {'ForeName': 'Katy', 'Initials': 'K', 'LastName': 'Araujo', 'Affiliation': 'Section of Geriatrics, Department of Internal Medicine, Yale University School of Medicine, New Haven, Connecticut, USA.'}, {'ForeName': 'Sangchoon', 'Initials': 'S', 'LastName': 'Jeon', 'Affiliation': 'Division of Acute Care/Health Systems, Yale School of Nursing, Yale University, New Haven, Connecticut, USA.'}, {'ForeName': 'Henry', 'Initials': 'H', 'LastName': 'Yaggi', 'Affiliation': 'Section of Pulmonary, Critical Care, and Sleep Medicine, Department of Internal Medicine, Yale University School of Medicine, New Haven, Connecticut, USA.'}]",BMJ open respiratory research,['10.1136/bmjresp-2019-000411'] 3291,31209158,Implementing Evidence-Based Strategies to Improve HPV Vaccine Delivery.,"BACKGROUND High-quality evidence indicates that intervening with health care providers improves human papillomavirus (HPV) vaccine delivery. However, scaling up evidence-based strategies in real-world clinical practice remains challenging. We sought to improve the reach and impact of strategies for HPV vaccination quality improvement (QI) through local adaptation and implementation in a large, not-for-profit health care system. METHODS We conducted an HPV vaccination QI program using existing materials to support physician training coupled with assessment and feedback. Local physicians with high HPV vaccination rates facilitated training, which included didactic instruction and video vignettes modeling effective communication. We randomly assigned 25 clinics with 77 physicians to the QI arm or the wait-list control arm. We used hierarchical linear models to assess HPV vaccination coverage (≥1 dose) over 6 months among patients aged 12 to 14. RESULTS Of 45 physicians in the QI arm, the program reached 43 (95%) with training plus assessment and feedback. In the overall sample, HPV vaccination coverage increased in both the QI and control arms (8.6 vs 6.4 percentage points, respectively), although the 2.2-percentage point difference did not reach statistical significance. Sensitivity analyses that excluded physicians with poor data quality indicated a statistically significant advantage of 3.3 percentage points for QI versus control ( b = 0.034; SE = 0.015; P < .05). CONCLUSIONS Our locally adapted QI program achieved excellent reach, with small improvements in HPV vaccination coverage. Future implementation research is needed to bolster program impact and support health systems in leveraging local resources to conduct these programs efficiently.",2019,"In the overall sample, HPV vaccination coverage increased in both the QI and control arms (8.6 vs 6.4 percentage points, respectively), although the 2.2-percentage point difference did not reach statistical significance.","['patients aged 12 to 14', 'Of 45 physicians in the QI arm']","['QI arm or the wait-list control arm', 'HPV vaccination QI program']",['HPV vaccination coverage'],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}]","[{'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0043010', 'cui_str': 'Waiting Lists'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0042196', 'cui_str': 'Vaccination'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C4505148', 'cui_str': 'Vaccination Coverage'}]",25.0,0.0601456,"In the overall sample, HPV vaccination coverage increased in both the QI and control arms (8.6 vs 6.4 percentage points, respectively), although the 2.2-percentage point difference did not reach statistical significance.","[{'ForeName': 'Melissa B', 'Initials': 'MB', 'LastName': 'Gilkey', 'Affiliation': 'Department of Health Behavior and gilkey@email.unc.edu.'}, {'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Parks', 'Affiliation': 'Department of Pediatrics, Medical School, University of Minnesota, Minneapolis, Minnesota; and.'}, {'ForeName': 'Marjorie A', 'Initials': 'MA', 'LastName': 'Margolis', 'Affiliation': 'Department of Health Behavior and.'}, {'ForeName': 'Annie-Laurie', 'Initials': 'AL', 'LastName': 'McRee', 'Affiliation': 'Department of Pediatrics, Medical School, University of Minnesota, Minneapolis, Minnesota; and.'}, {'ForeName': 'Jason V', 'Initials': 'JV', 'LastName': 'Terk', 'Affiliation': ""Cook Children's Health Care System, Fort Worth, Texas.""}]",Pediatrics,['10.1542/peds.2018-2500'] 3292,31104905,Expanded validation of the EPIC bowel and urinary domains for use in women with gynecologic cancer undergoing postoperative radiotherapy.,"OBJECTIVE Women with endometrial or cervical cancer at risk for recurrence receive postoperative radiation therapy (RT). A patient reported outcomes (PRO) instrument to assess bowel and urinary toxicities is the Expanded Prostate Cancer Index Composite (EPIC), which has been validated in men with prostate cancer. As this instrument specifically measures bowel toxicity and the degree to which this is a problem, it was used in NRG Oncology/RTOG 1203 to compare intensity modulated RT (IMRT) to standard RT. This paper reports on the expanded validation of EPIC for use in women receiving pelvic RT. METHODS In addition to the EPIC bowel domain, urinary toxicity (EPIC urinary domain), patient reported bowel toxicities (PRO-CTCAE) and quality of life (Functional Assessment of Cancer Therapy (FACT)) were completed before, during and after treatment. Sensitivity, reliability and concurrent validity were assessed. RESULTS Mean bowel and urinary scores among 278 women enrolled were significantly worse during treatment and differed between groups. Acceptable to good reliability for bowel and urinary domain scores were obtained at all time points with the exception of one at baseline. Correlations between function and bother scores within the bowel and urinary domains were consistently stronger than those across domains. Correlations between bowel domain scores and PRO-CTCAE during treatment were stronger than those with the FACT. CONCLUSION Correlations within and among the instruments indicate EPIC bowel and urinary domains are measuring conceptually discrete components of health. These EPIC domains are valid, reliable and sensitive instruments to measure PRO among women undergoing pelvic radiation.",2019,Acceptable to good reliability for bowel and urinary domain scores were obtained at all time points with the exception of one at baseline.,"['women undergoing pelvic radiation', 'Women with endometrial or cervical cancer at risk for recurrence receive', 'women with gynecologic cancer undergoing postoperative radiotherapy', '278 women enrolled', 'men with prostate cancer', 'women receiving pelvic RT']",['postoperative radiation therapy (RT'],"['bowel domain scores and PRO-CTCAE', 'EPIC bowel domain, urinary toxicity (EPIC urinary domain), patient reported bowel toxicities (PRO-CTCAE) and quality of life (Functional Assessment of Cancer Therapy (FACT', 'bowel and urinary toxicities', 'Mean bowel and urinary scores', 'good reliability for bowel and urinary domain scores', 'Sensitivity, reliability and concurrent validity']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0030797', 'cui_str': 'Pelvic Region'}, {'cui': 'C0851346', 'cui_str': 'Radiation'}, {'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix (disorder)'}, {'cui': 'C1444641', 'cui_str': 'At risk'}, {'cui': 'C2825055', 'cui_str': 'Recurrence'}, {'cui': 'C0205480', 'cui_str': 'Gynecologic (qualifier value)'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0243005', 'cui_str': 'Radiation Oncology'}, {'cui': 'C0086418', 'cui_str': 'Humans'}, {'cui': 'C0376358', 'cui_str': 'Prostate Cancer'}]","[{'cui': 'C0032790', 'cui_str': 'Postoperative Period'}, {'cui': 'C0034619', 'cui_str': 'radiation therapy'}]","[{'cui': 'C0021853', 'cui_str': 'Intestines'}, {'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0600688', 'cui_str': 'Toxic effect'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C0034380'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0205170', 'cui_str': 'Good (qualifier value)'}, {'cui': 'C0035035', 'cui_str': 'Reliability (Epidemiology)'}, {'cui': 'C0312418', 'cui_str': 'Sensitivity (finding)'}, {'cui': 'C0205420', 'cui_str': 'Concurrent (qualifier value)'}, {'cui': 'C0042283', 'cui_str': 'Validity (Epidemiology)'}]",278.0,0.0290365,Acceptable to good reliability for bowel and urinary domain scores were obtained at all time points with the exception of one at baseline.,"[{'ForeName': 'Karen M', 'Initials': 'KM', 'LastName': 'Gil', 'Affiliation': 'Summa Health, 525 East Market Street, Akron, OH 44304, USA. Electronic address: gilk@summahealth.org.'}, {'ForeName': 'Stephanie L', 'Initials': 'SL', 'LastName': 'Pugh', 'Affiliation': 'NRG Oncology Statistics and Data Management Center, 1818 Market Street, Suite 1720, Philadelphia, PA 19103, USA.'}, {'ForeName': 'Ann H', 'Initials': 'AH', 'LastName': 'Klopp', 'Affiliation': 'M D Anderson Cancer Center, Division of Radiation Oncology, 1515 Holcombe Boulevard, The University of Texas Unit 1422, Houston, TX 77030, USA.'}, {'ForeName': 'Anamaria R', 'Initials': 'AR', 'LastName': 'Yeung', 'Affiliation': 'University of Florida, Davis Cancer Center-Radiation Oncology, 2000 Southwest Archer Road, PO Box 100385, Gainesville, FL 32610, USA.'}, {'ForeName': 'Lari', 'Initials': 'L', 'LastName': 'Wenzel', 'Affiliation': 'University of California Medical Center at Irvine, 100 Theory Street, Suite 110, Irvine, CA 92697, USA.'}, {'ForeName': 'Shannon N', 'Initials': 'SN', 'LastName': 'Westin', 'Affiliation': 'M D Anderson Cancer Center, Department of Gynecologic Oncology, 1515 Holcombe Boulevard, The University of Texas Unit 1362, Houston, TX 77030, USA.'}, {'ForeName': 'David K', 'Initials': 'DK', 'LastName': 'Gaffney', 'Affiliation': 'Huntsman Cancer Institute/University of Utah, Department of Radiation Oncology, 1950 Circle of Hope Drive, Huntsman Cancer Hospital, Salt Lake City, UT 84112, USA.'}, {'ForeName': 'William', 'Initials': 'W', 'LastName': 'Small', 'Affiliation': 'Loyola University Medical Center, Radiation Oncology Department, 2160 South First Avenue, Maguire Center Suite 2944, Maywood, IL 60153, USA.'}, {'ForeName': 'Spencer', 'Initials': 'S', 'LastName': 'Thompson', 'Affiliation': 'University of Oklahoma Health Sciences Center, Department of Radiation Oncology, 800 NE 10th St L100, Oklahoma City, OK, 73104, USA.'}, {'ForeName': 'Desiree E', 'Initials': 'DE', 'LastName': 'Doncals', 'Affiliation': 'Summa Akron City Hospital/Cooper Cancer Center, 161 North Forge Street, Suite G90, Akron, OH 44304, USA.'}, {'ForeName': 'Guilherme H C', 'Initials': 'GHC', 'LastName': 'Cantuaria', 'Affiliation': 'Northside Hospital, Gynecologic Oncology, 960 Johnson Ferry Road Northeast, Suite 130, Atlanta, GA 30342, USA.'}, {'ForeName': 'Brian P', 'Initials': 'BP', 'LastName': 'Yaremko', 'Affiliation': 'London Regional Cancer Program, Department of Radiation Oncology, 790 Commissioners Road East, London Health Sciences Centre, London, ON N6A 4L6, Canada.'}, {'ForeName': 'Amy', 'Initials': 'A', 'LastName': 'Chang', 'Affiliation': 'Pamela Youde Nethersole Eastern Hospital, Department of Clinical Oncology, 3 Lok Man Road, Room 051 LG1 East Block, Chai Wan, Hong Kong, PR China.'}, {'ForeName': 'Vijayananda', 'Initials': 'V', 'LastName': 'Kundapur', 'Affiliation': 'Saskatoon Cancer Centre, 20 Campus Drive, Saskatoon, SK S7N 4H4, Canada.'}, {'ForeName': 'Dasarahally S', 'Initials': 'DS', 'LastName': 'Mohan', 'Affiliation': 'Kaiser Permanente Cancer Treatment Center, Department of Radiation Oncology, 220 Oyster Point Boulevard, South San Francisco, CA 94080, USA.'}, {'ForeName': 'Michael L', 'Initials': 'ML', 'LastName': 'Haas', 'Affiliation': 'Reading Hospital, Radiation Oncology Department, Sixth Avenue and Spruce Street, N Building Ground, West Reading, PA 19611, USA.'}, {'ForeName': 'Yong Bae', 'Initials': 'YB', 'LastName': 'Kim', 'Affiliation': 'Yonsei University Health System-Severance Hospital accruals for M D Anderson Cancer Center, Department of Radiation Oncology, 50-1 Yonsei-ro Seodaemun-gu, Seoul, 03722, South Korea.'}, {'ForeName': 'Catherine L', 'Initials': 'CL', 'LastName': 'Ferguson', 'Affiliation': 'Georgia Regents University, Section of Hematology and Oncology, 1120 15th Street, BAA-5407, Augusta, GA 30912, USA.'}, {'ForeName': 'Snehal', 'Initials': 'S', 'LastName': 'Deshmukh', 'Affiliation': 'NRG Oncology Statistics and Data Management Center, 1818 Market Street, Suite 1720, Philadelphia, PA 19103, USA.'}, {'ForeName': 'Lisa A', 'Initials': 'LA', 'LastName': 'Kachnic', 'Affiliation': 'Vanderbilt University School of Medicine, 2220 Pierce Avenue, Vanderbilt Clinic B-1003 TVC, Nashville, TN 37232, USA.'}, {'ForeName': 'Deborah W', 'Initials': 'DW', 'LastName': 'Bruner', 'Affiliation': 'Emory University, 1520 Clifton Road Northeast, Room 232, Atlanta, GA 30322, USA.'}]",Gynecologic oncology,['10.1016/j.ygyno.2019.04.682'] 3293,31107396,A Randomized Study of Values Affirmation to Promote Interest in Diabetes Prevention Among Women With a History of Gestational Diabetes.,"OBJECTIVE The objective of this study was to test whether 2 interventions promote interest in diabetes prevention among women with a history of gestational diabetes mellitus, who face high lifetime risk for diabetes. RESEARCH DESIGN AND METHODS We designed an email outreach message promoting an existing preventive lifestyle program. The message incorporated values affirmation, a theory-based intervention that can improve openness to health information but typically relies on a writing exercise less practical in health care settings. In a 3-arm randomized study, 237 women with elevated body mass index and a history of gestational diabetes mellitus were randomized to read an outreach message containing either no affirmation (control) or 1 of 2 affirmations, streamlined to remove the typical writing exercise: either a values affirmation prompting reflection on any personal value, or a parenting affirmation prompting reflection on caregiving-related values. Outcomes included demonstrating interest in the lifestyle program (seeking information about it or intending to join) and seeking publicly-available health information about diabetes prevention. RESULTS Compared with control, participants randomized to the values affirmation more frequently demonstrated interest in the lifestyle program (59.0% vs. 74.4%; adjusted relative risk: 1.31; 95% confidence interval: 1.04-1.66) and sought information about diabetes prevention (59.0% vs. 73.4%; adjusted relative risk: 1.22; 95% confidence interval: 0.97-1.54). The parenting affirmation yielded no significant differences in either outcome. CONCLUSIONS A streamlined values affirmation, designed for feasibility in a health care setting, can promote interest in diabetes prevention among women at high risk. Research is needed to evaluate its effects on diabetes prevention program enrollment and clinical outcomes.",2019,"Compared with control, participants randomized to the values affirmation more frequently demonstrated interest in the lifestyle program (59.0% vs. 74.4%; adjusted relative risk: 1.31; 95% confidence interval: 1.04-1.66) and sought information about diabetes prevention (59.0% vs. 73.4%; adjusted relative risk: 1.22; 95% confidence interval: 0.97-1.54).","['women at high risk', 'Diabetes Prevention', 'women with a history of gestational diabetes mellitus, who face high lifetime risk for diabetes', '237 women with elevated body mass index and a history of gestational diabetes mellitus', 'Women With a History of Gestational Diabetes']","['outreach message containing either no affirmation (control) or 1 of 2 affirmations, streamlined to remove the typical writing exercise: either a values affirmation prompting reflection on any personal value, or a parenting affirmation prompting reflection on caregiving-related values', 'email outreach message promoting an existing preventive lifestyle program']",['lifestyle program (seeking information about it or intending to join) and seeking publicly-available health information about diabetes prevention'],"[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C2183115', 'cui_str': 'History of gestational diabetes mellitus (situation)'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C0262926', 'cui_str': 'History of (contextual qualifier) (qualifier value)'}, {'cui': 'C0439671', 'cui_str': 'Gestational (qualifier value)'}]","[{'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C1883720', 'cui_str': 'Removes'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0013849', 'cui_str': 'Email'}, {'cui': 'C1456501', 'cui_str': 'Preventive'}, {'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C2728259', 'cui_str': 'Program'}]","[{'cui': 'C0023676', 'cui_str': 'Lifestyle'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0470187', 'cui_str': 'Availability of (contextual qualifier) (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}]",237.0,0.0616396,"Compared with control, participants randomized to the values affirmation more frequently demonstrated interest in the lifestyle program (59.0% vs. 74.4%; adjusted relative risk: 1.31; 95% confidence interval: 1.04-1.66) and sought information about diabetes prevention (59.0% vs. 73.4%; adjusted relative risk: 1.22; 95% confidence interval: 0.97-1.54).","[{'ForeName': 'Susan D', 'Initials': 'SD', 'LastName': 'Brown', 'Affiliation': 'Division of Research, Kaiser Permanente Northern California, Oakland.'}, {'ForeName': 'Omid', 'Initials': 'O', 'LastName': 'Fotuhi', 'Affiliation': 'Department of Psychology, Stanford University, Stanford, CA.'}, {'ForeName': 'Christina S', 'Initials': 'CS', 'LastName': 'Grijalva', 'Affiliation': 'Division of Research, Kaiser Permanente Northern California, Oakland.'}, {'ForeName': 'Ai-Lin', 'Initials': 'AL', 'LastName': 'Tsai', 'Affiliation': 'Division of Research, Kaiser Permanente Northern California, Oakland.'}, {'ForeName': 'Charles P', 'Initials': 'CP', 'LastName': 'Quesenberry', 'Affiliation': 'Division of Research, Kaiser Permanente Northern California, Oakland.'}, {'ForeName': 'Jenna L', 'Initials': 'JL', 'LastName': 'Ritchie', 'Affiliation': 'Division of Research, Kaiser Permanente Northern California, Oakland.'}, {'ForeName': 'Geoffrey L', 'Initials': 'GL', 'LastName': 'Cohen', 'Affiliation': 'Department of Psychology, Stanford University, Stanford, CA.'}, {'ForeName': 'Assiamira', 'Initials': 'A', 'LastName': 'Ferrara', 'Affiliation': 'Division of Research, Kaiser Permanente Northern California, Oakland.'}]",Medical care,['10.1097/MLR.0000000000001133'] 3294,31135692,Change in Patient Outcomes After Augmenting a Low-level Implementation Strategy in Community Practices That Are Slow to Adopt a Collaborative Chronic Care Model: A Cluster Randomized Implementation Trial.,"BACKGROUND Implementation strategies are essential for promoting the uptake of evidence-based practices and for patients to receive optimal care. Yet strategies differ substantially in their intensity and feasibility. Lower-intensity strategies (eg, training and technical support) are commonly used but may be insufficient for all clinics. Limited research has examined the comparative effectiveness of augmentations to low-level implementation strategies for nonresponding clinics. OBJECTIVES To compare 2 augmentation strategies for improving uptake of an evidence-based collaborative chronic care model (CCM) on 18-month outcomes for patients with depression at community-based clinics nonresponsive to lower-level implementation support. RESEARCH DESIGN Providers initially received support using a low-level implementation strategy, Replicating Effective Programs (REP). After 6 months, nonresponsive clinics were randomized to add either external facilitation (REP+EF) or external and internal facilitation (REP+EF/IF). MEASURES The primary outcome was patient 12-item short form survey (SF-12) mental health score at month 18. Secondary outcomes were patient health questionnaire (PHQ-9) depression score at month 18 and receipt of the CCM during months 6 through 18. RESULTS Twenty-seven clinics were nonresponsive after 6 months of REP. Thirteen clinics (N=77 patients) were randomized to REP+EF and 14 (N=92) to REP+EF/IF. At 18 months, patients in the REP+EF/IF arm had worse SF-12 [diff, 8.38; 95% confidence interval (CI), 3.59-13.18] and PHQ-9 scores (diff, 1.82; 95% CI, -0.14 to 3.79), and lower odds of CCM receipt (odds ratio, 0.67; 95% CI, 0.30-1.49) than REP+EF patients. CONCLUSIONS Patients at sites receiving the more intensive REP+EF/IF saw less improvement in mood symptoms at 18 months than those receiving REP+EF and were no more likely to receive the CCM. For community-based clinics, EF augmentation may be more feasible than EF/IF for implementing CCMs.",2019,"At 18 months, patients in the REP+EF/IF arm had worse SF-12 [diff, 8.38; 95% confidence interval (CI), 3.59-13.18] and PHQ-9 scores (diff, 1.82; 95% CI, -0.14 to 3.79), and lower odds of CCM receipt (odds ratio, 0.67; 95% CI, 0.30-1.49) than REP+EF patients. ","['patients with depression at community-based clinics nonresponsive to lower-level implementation support', 'Community Practices', 'Thirteen clinics (N=77 patients']","['REP+EF', 'REP+EF/IF', 'external facilitation (REP+EF) or external and internal facilitation (REP+EF/IF', 'collaborative chronic care model (CCM']","['patient health questionnaire (PHQ-9) depression score', 'PHQ-9 scores', 'patient 12-item short form survey (SF-12) mental health score', 'mood symptoms']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0442592', 'cui_str': 'Clinic (environment)'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0344211', 'cui_str': 'Supportive care'}, {'cui': 'C3715149', 'cui_str': '13'}]","[{'cui': 'C0205101', 'cui_str': 'External (qualifier value)'}, {'cui': 'C0234112', 'cui_str': 'Facilitation, function (observable entity)'}, {'cui': 'C0205102', 'cui_str': 'Internal (qualifier value)'}, {'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}]","[{'cui': 'C1879301', 'cui_str': 'Patient Health Questionnaire'}, {'cui': 'C4083201', 'cui_str': 'PHQ-9'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0376315', 'cui_str': 'Form'}, {'cui': 'C0038951', 'cui_str': 'Surveys'}, {'cui': 'C0025353', 'cui_str': 'Mental Hygiene'}, {'cui': 'C0026516', 'cui_str': 'Mood'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",27.0,0.153453,"At 18 months, patients in the REP+EF/IF arm had worse SF-12 [diff, 8.38; 95% confidence interval (CI), 3.59-13.18] and PHQ-9 scores (diff, 1.82; 95% CI, -0.14 to 3.79), and lower odds of CCM receipt (odds ratio, 0.67; 95% CI, 0.30-1.49) than REP+EF patients. ","[{'ForeName': 'Shawna N', 'Initials': 'SN', 'LastName': 'Smith', 'Affiliation': 'Department of Psychiatry, University of Michigan Medical School.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Almirall', 'Affiliation': 'Institute for Social Research.'}, {'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Prenovost', 'Affiliation': 'Department of Psychiatry, University of Michigan Medical School.'}, {'ForeName': 'Celeste', 'Initials': 'C', 'LastName': 'Liebrecht', 'Affiliation': 'Department of Psychiatry, University of Michigan Medical School.'}, {'ForeName': 'Julia', 'Initials': 'J', 'LastName': 'Kyle', 'Affiliation': 'Department of Psychiatry, University of Michigan Medical School.'}, {'ForeName': 'Daniel', 'Initials': 'D', 'LastName': 'Eisenberg', 'Affiliation': 'Department of Health Management and Policy, School of Public Health, University of Michigan Ann Arbor, MI.'}, {'ForeName': 'Mark S', 'Initials': 'MS', 'LastName': 'Bauer', 'Affiliation': 'US Department of Veterans Affairs, Center for Healthcare Organization and Implementation Research, US Department of Veterans Affairs, Boston Healthcare System and Harvard Medical School, Boston, MA.'}, {'ForeName': 'Amy M', 'Initials': 'AM', 'LastName': 'Kilbourne', 'Affiliation': 'Department of Psychiatry, University of Michigan Medical School.'}]",Medical care,['10.1097/MLR.0000000000001138'] 3295,30829836,Approaches to Recruitment of Postmenopausal Women for a Community-Based Study.,"BACKGROUND Few researchers have focused on the challenges of recruiting postmenopausal women for community-based research. Researchers have reported that multiple methods may be needed to recruit the required number of subjects. One contemporary approach to recruitment is use of Facebook. More studies are needed examining Facebook as a recruitment strategy. OBJECTIVE The aim of the study was to examine which recruitment methods were most successful and cost-effective in recruiting postmenopausal women for a randomized controlled trial on bone loss. METHODS Subjects were 276 postmenopausal women who had osteopenia and were within 5 years of menopause. Multiple methods were used to recruit women. To determine which methods were successful, women were asked how they learned about the study. Descriptive data were used to examine recruitment numbers as well as to determine the cost-effectiveness and enrollment efficiency of recruitment methods. RESULTS Healthcare provider letters yielded the highest number of enrolled subjects (n = 58), followed by postcard mailings (n = 47), and Facebook posts (n = 44). Eleven subjects were referred by family and friends, five subjects were from newspaper or television, and two were from digital ads. Cost of recruitment per subject enrolled was highest with digital ads and postcard mailings. DISCUSSION Recruitment could be more costly and time-consuming than anticipated. Recruitment using direct-targeted mailings, such as provider letters and postcards, was successful in our study and has been effective in previous studies reviewed. Facebook was successful for recruitment in our study and may continue to be useful for recruitment in the future, as the number of women accessing Facebook continues to increase.",2019,"RESULTS Healthcare provider letters yielded the highest number of enrolled subjects (n = 58), followed by postcard mailings (n = 47), and Facebook posts (n = 44).","['postmenopausal women', 'Eleven subjects were referred by family and friends, five subjects were from newspaper or television, and two were from digital ads', 'Subjects were 276 postmenopausal women who had osteopenia and were within 5 years of menopause', 'Postmenopausal Women for a Community-Based Study']",['Facebook'],[],"[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0422318', 'cui_str': 'Referred by family (finding)'}, {'cui': 'C0079382', 'cui_str': 'Friend (person)'}, {'cui': 'C0027989', 'cui_str': 'Newspapers'}, {'cui': 'C0039461', 'cui_str': 'Television'}, {'cui': 'C0442015', 'cui_str': 'Digital X-ray (qualifier value)'}, {'cui': 'C0029453', 'cui_str': 'Osteopenia'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0567312', 'cui_str': 'Menopause present (finding)'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]",[],[],276.0,0.0908928,"RESULTS Healthcare provider letters yielded the highest number of enrolled subjects (n = 58), followed by postcard mailings (n = 47), and Facebook posts (n = 44).","[{'ForeName': 'Nancy L', 'Initials': 'NL', 'LastName': 'Waltman', 'Affiliation': 'Nancy L. Waltman, PhD, APRN-CNP, is Professor, College of Nursing, University of Nebraska Medical Center, Lincoln. Kara M. Smith, MS, is Project Study Coordinator, College of Allied Health Professions, University of Nebraska Medical Center, Omaha. Kevin A. Kupzyk, PhD, is Assistant Professor, College of Nursing, University of Nebraska Medical Center, Omaha. Joan M. Lappe, PhD, RN, FAAN, is Professor, Creighton University, Omaha, Nebraska. Lynn R. Mack, MD, is Associate Professor, College of Medicine, University of Nebraska Medical Center, Omaha. Laura D. Bilek, PhD, PT, is Associate Professor, College of Allied Health Professions, University of Nebraska Medical Center, Omaha.'}, {'ForeName': 'Kara M', 'Initials': 'KM', 'LastName': 'Smith', 'Affiliation': ''}, {'ForeName': 'Kevin A', 'Initials': 'KA', 'LastName': 'Kupzyk', 'Affiliation': ''}, {'ForeName': 'Joan M', 'Initials': 'JM', 'LastName': 'Lappe', 'Affiliation': ''}, {'ForeName': 'Lynn R', 'Initials': 'LR', 'LastName': 'Mack', 'Affiliation': ''}, {'ForeName': 'Laura D', 'Initials': 'LD', 'LastName': 'Bilek', 'Affiliation': ''}]",Nursing research,['10.1097/NNR.0000000000000356'] 3296,30930208,Individual differences in TMS sensitivity influence the efficacy of tDCS in facilitating sensorimotor adaptation.,"BACKGROUND Transcranial direct current stimulation (tDCS) can enhance cognitive function in healthy individuals, with promising applications as a therapeutic intervention. Despite this potential, variability in the efficacy of tDCS has been a considerable concern. OBJECTIVE /Hypothesis: Given that tDCS is always applied at a set intensity, we examined whether individual differences in sensitivity to brain stimulation might be one variable that modulates the efficacy of tDCS in a motor learning task. METHODS In the first part of the experiment, single-pulse transcranial magnetic stimulation (TMS) over primary motor cortex (M1) was used to determine each participant's resting motor threshold (rMT). This measure was used as a proxy of individual sensitivity to brain stimulation. In an experimental group of 28 participants, 2 mA tDCS was then applied during a motor learning task with the anodal electrode positioned over left M1. Another 14 participants received sham stimulation. RESULTS M1-Anodal tDCS facilitated learning relative to participants who received sham stimulation. Of primary interest was a within-group analysis of the experimental group, showing that the rate of learning was positively correlated with rMT: Participants who were more sensitive to brain stimulation as operationalized by our TMS proxy (low rMT), showed faster adaptation. CONCLUSIONS Methodologically, the results indicate that TMS sensitivity can predict tDCS efficacy in a behavioral task, providing insight into one source of variability that may contribute to replication problems with tDCS. Theoretically, the results provide further evidence of a role of sensorimotor cortex in adaptation, with the boost from tDCS observed during acquisition.",2019,"Of primary interest was a within-group analysis of the experimental group, showing that the rate of learning was positively correlated with rMT: Participants who were more sensitive to brain stimulation as operationalized by our TMS proxy (low rMT), showed faster adaptation. ",['healthy individuals'],"['single-pulse transcranial magnetic stimulation (TMS', 'Transcranial direct current stimulation (tDCS', 'tDCS', 'sham stimulation']",['rate of learning'],"[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}]","[{'cui': 'C1564622', 'cui_str': 'Transcranial Magnetic Stimulation, Single Pulse'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C1292856', 'cui_str': 'Stimulation procedure (procedure)'}]",[],28.0,0.0188188,"Of primary interest was a within-group analysis of the experimental group, showing that the rate of learning was positively correlated with rMT: Participants who were more sensitive to brain stimulation as operationalized by our TMS proxy (low rMT), showed faster adaptation. ","[{'ForeName': 'L', 'Initials': 'L', 'LastName': 'Labruna', 'Affiliation': 'Department of Psychology, University of California, 94704, Berkeley, CA, USA; Helen Wills Neuroscience Institute, University of California, 94704, Berkeley, CA, USA. Electronic address: lulabrun@gmail.com.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Stark-Inbar', 'Affiliation': 'Department of Psychology, University of California, 94704, Berkeley, CA, USA; Helen Wills Neuroscience Institute, University of California, 94704, Berkeley, CA, USA.'}, {'ForeName': 'A', 'Initials': 'A', 'LastName': 'Breska', 'Affiliation': 'Department of Psychology, University of California, 94704, Berkeley, CA, USA; Helen Wills Neuroscience Institute, University of California, 94704, Berkeley, CA, USA.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Dabit', 'Affiliation': 'Department of Psychology, University of California, 94704, Berkeley, CA, USA.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Vanderschelden', 'Affiliation': 'Department of Psychology, University of California, 94704, Berkeley, CA, USA.'}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Nitsche', 'Affiliation': 'Leibniz Research Center for Working Environment and Human Factors, 44139, Dortmund, Germany.'}, {'ForeName': 'R B', 'Initials': 'RB', 'LastName': 'Ivry', 'Affiliation': 'Department of Psychology, University of California, 94704, Berkeley, CA, USA; Helen Wills Neuroscience Institute, University of California, 94704, Berkeley, CA, USA.'}]",Brain stimulation,['10.1016/j.brs.2019.03.008'] 3297,30184183,Safety and Immunogenicity of Pneumococcal Conjugate Vaccines in a High-risk Population: A Randomized Controlled Trial of 10-Valent and 13-Valent Pneumococcal Conjugate Vaccine in Papua New Guinean Infants.,"BACKGROUND There are little data on the immunogenicity of PCV10 and PCV13 in the same high-risk population. METHODS PCV10 and PCV13 were studied head-to-head in a randomized controlled trial in Papua New Guinea in which 262 infants received 3 doses of PCV10 or PCV13 at 1, 2, and 3 months of age. Serotype-specific immunoglobulin G (IgG) concentrations, and pneumococcal and nontypeable Haemophilus influenzae (NTHi) carriage were assessed prevaccination and at 4 and 9 months of age. Infants were followed up for safety until 9 months of age. RESULTS One month after the third dose of PCV10 or PCV13, ˃80% of infants had IgG concentrations ≥0.35µg/mL for vaccine serotypes, and 6 months postvaccination IgG concentrations ≥0.35 µg/mL were maintained for 8/10 shared PCV serotypes in > 75% of children vaccinated with either PCV10 or PCV13. Children carried a total of 65 different pneumococcal serotypes (plus nonserotypeable). At 4 months of age, 92% (95% confidence interval [CI] 85-96) of children vaccinated with PCV10 and 81% (95% CI 72-88) vaccinated with PCV13 were pneumococcal carriers (P = .023), whereas no differences were seen at 9 months of age, or for NTHi carriage. Both vaccines were well tolerated and not associated with serious adverse events. CONCLUSIONS Infant vaccination with 3 doses of PCV10 or PCV13 is safe and immunogenic in a highly endemic setting; however, to significantly reduce pneumococcal disease in these settings, PCVs with broader serotype coverage and potency to reduce pneumococcal carriage are needed. CLINICAL TRIALS REGISTRATION NCT01619462.",2019,"Infant vaccination with 3 doses of PCV10 or PCV13 is safe and immunogenic in a highly endemic setting; however, to significantly reduce pneumococcal disease in these settings, PCVs with broader serotype coverage and potency to reduce pneumococcal carriage are needed. ","['a High-risk Population', 'Papua New Guinean Infants', 'PCV10 and PCV13 were studied head-to-head in a randomized controlled trial in Papua New Guinea in which 262 infants received 3 doses of']","['Serotype-specific immunoglobulin G (IgG) concentrations, and pneumococcal and nontypeable Haemophilus influenzae ', 'PCV10 or PCV13', 'Pneumococcal Conjugate Vaccines', '10-Valent and 13-Valent Pneumococcal Conjugate Vaccine']","['postvaccination IgG concentrations', 'Safety and Immunogenicity']","[{'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0205314', 'cui_str': 'New (qualifier value)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C3849486', 'cui_str': 'ten-valent PCV'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0018670', 'cui_str': 'Head'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0030375', 'cui_str': 'New Guinea, East'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}]","[{'cui': 'C0449550', 'cui_str': 'Serotype (UK)'}, {'cui': 'C0358334', 'cui_str': 'Specific immunoglobulins'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0018483', 'cui_str': 'Haemophilus influenzae'}, {'cui': 'C3849486', 'cui_str': 'ten-valent PCV'}, {'cui': 'C1579319', 'cui_str': 'Streptococcus pneumoniae conjugate vaccine'}]","[{'cui': 'C0020852', 'cui_str': 'Immunoglobulin G'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",262.0,0.31886,"Infant vaccination with 3 doses of PCV10 or PCV13 is safe and immunogenic in a highly endemic setting; however, to significantly reduce pneumococcal disease in these settings, PCVs with broader serotype coverage and potency to reduce pneumococcal carriage are needed. ","[{'ForeName': 'William S', 'Initials': 'WS', 'LastName': 'Pomat', 'Affiliation': 'Papua New Guinea Institute of Medical Research, Goroka.'}, {'ForeName': 'Anita H J', 'Initials': 'AHJ', 'LastName': 'van den Biggelaar', 'Affiliation': 'Wesfarmers Centre of Vaccines and Infectious Diseases, Telethon Kids Institute and Centre for Child Health Research, University of Western Australia, Perth.'}, {'ForeName': 'Sandra', 'Initials': 'S', 'LastName': 'Wana', 'Affiliation': 'Papua New Guinea Institute of Medical Research, Goroka.'}, {'ForeName': 'Jacinta P', 'Initials': 'JP', 'LastName': 'Francis', 'Affiliation': 'Papua New Guinea Institute of Medical Research, Goroka.'}, {'ForeName': 'Vela', 'Initials': 'V', 'LastName': 'Solomon', 'Affiliation': 'Papua New Guinea Institute of Medical Research, Goroka.'}, {'ForeName': 'Andrew R', 'Initials': 'AR', 'LastName': 'Greenhill', 'Affiliation': 'Papua New Guinea Institute of Medical Research, Goroka.'}, {'ForeName': 'Rebecca', 'Initials': 'R', 'LastName': 'Ford', 'Affiliation': 'Papua New Guinea Institute of Medical Research, Goroka.'}, {'ForeName': 'Tilda', 'Initials': 'T', 'LastName': 'Orami', 'Affiliation': 'Papua New Guinea Institute of Medical Research, Goroka.'}, {'ForeName': 'Megan', 'Initials': 'M', 'LastName': 'Passey', 'Affiliation': 'The University of Sydney, University Centre for Rural Health, School of Public Health, Lismore, New South Wales.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Jacoby', 'Affiliation': 'Department of Biostatistics, Telethon Kids Institute and Centre for Child Health Research, University of Western Australia, Perth.'}, {'ForeName': 'Lea-Ann', 'Initials': 'LA', 'LastName': 'Kirkham', 'Affiliation': 'Wesfarmers Centre of Vaccines and Infectious Diseases, Telethon Kids Institute and Centre for Child Health Research, University of Western Australia, Perth.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'Lehmann', 'Affiliation': 'Wesfarmers Centre of Vaccines and Infectious Diseases, Telethon Kids Institute and Centre for Child Health Research, University of Western Australia, Perth.'}, {'ForeName': 'Peter C', 'Initials': 'PC', 'LastName': 'Richmond', 'Affiliation': 'Wesfarmers Centre of Vaccines and Infectious Diseases, Telethon Kids Institute and Centre for Child Health Research, University of Western Australia, Perth.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Clinical infectious diseases : an official publication of the Infectious Diseases Society of America,['10.1093/cid/ciy743'] 3298,31209720,Effectiveness of Sterilized Symbiotic Drink Containing Lactobacillus helveticus Comparable to Probiotic Alone in Patients with Constipation-Predominant Irritable Bowel Syndrome.,"BACKGROUND This study aimed to objectively investigate whether the addition of polydextrose to sterilized probiotic containing Lactobacillus helveticus will confer benefits to constipation-predominant irritable bowel syndrome patients. METHODS A total of 163 patients were randomized into two groups: Group A to consume 350 mL of sterilized probiotic with 5.85 g polydextrose daily for 1 week and Group B without polydextrose. Intestinal transit time, fecal pH, fecal weight, and modified Garrigues questionnaires for pre- and post-consumption were assessed. RESULTS Median intestinal transit time was significantly reduced from 58 (IQR 43-72) to 45 (IQR 24-59) hours and 48 (IQR 31-72) to 30 (IQR 24-49) hours for Groups A and B, respectively (p < 0.01). Fecal pH for Groups A and B was significantly reduced from 6.57 ± 0.96 to 6.13 ± 0.95 (p = 0.003) and 6.58 ± 1.0 to 5.87 ± 0.83 (p < 0.001), respectively. Fecal weight for Group A was significantly increased from 8 g ± 6.4 g to 9.8 g ± 7.6 g (p = 0.003), but it was reduced for Group B from 13.3 g ± 19.4 g to 11.2 g ± 6.6 g (p = 0.308). Constipation-related symptoms were significantly improved for both groups. CONCLUSIONS The addition of polydextrose to sterilized probiotic containing L. helveticus did not show significant benefits to constipation-predominant irritable bowel syndrome patients. However, daily consumption of sterilized probiotic containing L. helveticus with or without polydextrose for a week alleviated constipation-related symptoms and objectively reduced both fecal pH and intestinal transit time.",2020,The addition of polydextrose to sterilized probiotic containing L. helveticus did not show significant benefits to constipation-predominant irritable bowel syndrome patients.,"['constipation-predominant irritable bowel syndrome patients', 'Patients with Constipation-Predominant Irritable Bowel Syndrome', '163 patients']","['Sterilized Symbiotic Drink Containing Lactobacillus helveticus', 'Probiotic Alone', 'Group A to consume 350\xa0mL of sterilized probiotic with 5.85', 'polydextrose to sterilized probiotic containing Lactobacillus helveticus']","['Median intestinal transit time', 'Intestinal transit time, fecal pH, fecal weight, and modified Garrigues questionnaires for pre- and post-consumption', 'Fecal pH', 'Fecal weight', 'fecal pH and intestinal transit time', 'Constipation-related symptoms']","[{'cui': 'C1868889', 'cui_str': 'Irritable bowel syndrome characterized by constipation'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0452428', 'cui_str': 'Drinks (substance)'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0317592', 'cui_str': 'Lactobacillus helveticus'}, {'cui': 'C0525033', 'cui_str': 'Probiotics'}, {'cui': 'C0441835', 'cui_str': 'Group A (qualifier value)'}, {'cui': 'C4517735', 'cui_str': '350'}, {'cui': 'C0071545', 'cui_str': 'polydextrose'}]","[{'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C3665877', 'cui_str': 'Intestinal transit time'}, {'cui': 'C2711455', 'cui_str': 'pH of stool'}, {'cui': 'C1305866', 'cui_str': 'Weighing patient (procedure)'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0009806', 'cui_str': 'Constipation'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]",163.0,0.0475529,The addition of polydextrose to sterilized probiotic containing L. helveticus did not show significant benefits to constipation-predominant irritable bowel syndrome patients.,"[{'ForeName': 'Mohd Fyzal', 'Initials': 'MF', 'LastName': 'Bahrudin', 'Affiliation': 'Gastroenterology Unit, Department of Medicine, Faculty of Medicine, Universiti Kebangsaan Malaysia, Jalan Yaacob Latiff, Bandar Tun Razak, 56000, Cheras, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Rafiz', 'Initials': 'R', 'LastName': 'Abdul Rani', 'Affiliation': 'Gastroenterology Unit, Faculty of Medicine, Universiti Teknologi MARA, 47000, Sungai Buloh, Selangor, Malaysia.'}, {'ForeName': 'Azmi Mohd', 'Initials': 'AM', 'LastName': 'Tamil', 'Affiliation': 'Department of Community Health, Faculty of Medicine, Universiti Kebangsaan Malaysia, Jalan Yaacob Latif, Bandar Tun Razak, 56000, Cheras, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Norfilza Mohd', 'Initials': 'NM', 'LastName': 'Mokhtar', 'Affiliation': 'Department of Physiology, Faculty of Medicine, Universiti Kebangsaan Malaysia, Jalan Yaacob Latif, Bandar Tun Razak, 56000, Cheras, Kuala Lumpur, Malaysia.'}, {'ForeName': 'Raja Affendi', 'Initials': 'RA', 'LastName': 'Raja Ali', 'Affiliation': 'Gastroenterology Unit, Department of Medicine, Faculty of Medicine, Universiti Kebangsaan Malaysia, Jalan Yaacob Latiff, Bandar Tun Razak, 56000, Cheras, Kuala Lumpur, Malaysia. draffendi@ppukm.ukm.edu.my.'}]",Digestive diseases and sciences,['10.1007/s10620-019-05695-3'] 3299,30232744,"Effects of Probiotic Yogurt on Serum Omentin-1, Adropin, and Nesfatin-1 Concentrations in Overweight and Obese Participants Under Low-Calorie Diet.","Data on the effects of probiotics on adipokines such as omentin-1, nesfatin-1, and adropin are limited. The aim of this study was to evaluate the effects of probiotic yogurt along with a low-calorie diet (LCD) on serum omentin-1, adropin, and nesfatin-1 concentrations in obese and overweight individuals. Sixty obese or overweight individuals aged 20-50 years old were involved in this randomized double-blind placebo-controlled clinical trial. Participants were randomly allocated into two groups to consume either probiotic yogurt containing Lactobacillus acidophilus La5, Bifidobacterium BB12, and Lactobacillus casei DN001 (10 8  CFU/g each) (n = 30) or regular yogurt (n = 30) along with a LCD in both groups for 8 weeks. Fasting blood samples were taken at baseline and after the 8-week intervention to determine related variables. A significant decrease in body fat percentage was observed in the probiotic group compared with the regular group after 8 weeks (- 1.51 ± 069 vs - 0.88 ± 0.68%, P = 0.002). After the 8-week intervention, a significant difference in serum adropin concentration (6.04 ± 24.46 vs - 8.16 ± 24.66 pg/ml, P = 0.03 and serum omentin-1 concentration (0.09 ± 1.51 vs - 1.5 ± 1.8 ng/ml, P = 0.003) was observed between two groups. We did not observe any significant changes in nesfatin-1 and other anthropometric measures. Overall, probiotic yogurt for 8 weeks among overweight or obese individuals along with LCD had beneficial effects on body fat percentage, serum omentin-1, and adropin concentration, but it did not have any effect on nesfatin-1 level.",2019,"A significant decrease in body fat percentage was observed in the probiotic group compared with the regular group after 8 weeks (- 1.51 ± 069 vs - 0.88 ± 0.68%, P = 0.002).","['Sixty obese or overweight individuals aged 20-50\xa0years old', 'obese and overweight individuals', 'Overweight and Obese Participants Under Low-Calorie Diet']","['Probiotic Yogurt', 'probiotic yogurt containing Lactobacillus acidophilus La5, Bifidobacterium BB12, and Lactobacillus casei DN001', 'low-calorie diet (LCD', 'placebo']","['body fat percentage, serum omentin-1, and adropin concentration', 'serum adropin concentration', 'serum omentin-1, adropin, and nesfatin-1 concentrations', 'Fasting blood samples', 'serum omentin-1 concentration', 'Serum Omentin-1, Adropin, and Nesfatin-1 Concentrations', 'body fat percentage']","[{'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0497406', 'cui_str': 'Overweight'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C2930544', 'cui_str': 'Low-Calorie Diet'}]","[{'cui': 'C3853203', 'cui_str': 'Probiotic yogurt'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0022939', 'cui_str': 'Lactobacillus acidophilus'}, {'cui': 'C0005380', 'cui_str': 'Bifidobacterium'}, {'cui': 'C0022940', 'cui_str': 'Lactobacillus casei'}, {'cui': 'C2930544', 'cui_str': 'Low-Calorie Diet'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0344335', 'cui_str': 'Body Fat'}, {'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0178913', 'cui_str': 'Blood specimen'}]",,0.0535447,"A significant decrease in body fat percentage was observed in the probiotic group compared with the regular group after 8 weeks (- 1.51 ± 069 vs - 0.88 ± 0.68%, P = 0.002).","[{'ForeName': 'Mitra', 'Initials': 'M', 'LastName': 'Zarrati', 'Affiliation': 'Department of Nutrition, School of Public Health, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Mahsa', 'Initials': 'M', 'LastName': 'Raji Lahiji', 'Affiliation': 'Department of Nutrition, School of Public Health, Iran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Eisa', 'Initials': 'E', 'LastName': 'Salehi', 'Affiliation': 'Immunology Department, Faculty of Medicine, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Bahareh', 'Initials': 'B', 'LastName': 'Yazdani', 'Affiliation': 'Department of Microbiology, School of Biology Sciences, Islamic Azad University, Tehran, Iran.'}, {'ForeName': 'Elham', 'Initials': 'E', 'LastName': 'Razmpoosh', 'Affiliation': 'Department of Nutrition, Faculty of Health, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.'}, {'ForeName': 'Raheleh', 'Initials': 'R', 'LastName': 'Shokouhi Shoormasti', 'Affiliation': 'Immunology, Asthma and Allergy Research Institute, Tehran University of Medical Sciences, Tehran, Iran.'}, {'ForeName': 'Farzad', 'Initials': 'F', 'LastName': 'Shidfar', 'Affiliation': 'Department of Nutrition, School of Public Health, Iran University of Medical Sciences, Tehran, Iran. farzadshidfar@yahoo.com.'}]",Probiotics and antimicrobial proteins,['10.1007/s12602-018-9470-3'] 3300,31366275,Effects of acute pain and pain-related fear on risky decision-making and effort during cognitive tests.,"Introduction : The experience of acute pain and pain-related fear negatively impact cognition and behavior; however, little research has examined their impacts on risky decision-making and effort. The present study investigated the effects of acute pain and pain-related fear on risky decision-making and effort during cognitive tests. Method : Levels of pain-related fear were assessed. Healthy participants ( n = 146) experienced acute pain induced via cold pressor task, and then were randomly assigned to one of the four conditions to induce pain-related fear: Pain Threat ( n = 36), Pain Threat with Control ( n = 39), Cognitive Threat with Control ( n = 34), and Control ( n = 36). Participants then completed measures of effort (Word Memory Test [WMT], self-reported effort) and risky decision-making (Iowa Gambling Task [IGT], Balloon Analogue Risk Task [BART]). Results : Collapsed across condition, participants did not learn to decide advantageously on the IGT following an acute pain experience. During the early trials (1-40) on the IGT, participants in the Pain Threat condition made riskier decisions. Higher levels of pain during the cold pressor task predicted less risky decisions on the BART, and participants in the Cognitive Threat with Control condition made less risky decisions. Participants in the Pain Threat with Control condition self-reported lower effort on cognitive tests, yet no group-based differences were seen in WMT performance. Greater pain-related fear predicted greater self-reported effort and better WMT performance, but no effects were seen on decision-making task performance. Conclusions : The experience of pain and the threat of additional pain can lead to changes in risky decision-making and effort on cognitive tasks. This threat of additional pain could activate underlying pain-related fear, creating hypervigilance to and avoidance of pain that affects subsequent task performance. Implications for research and clinical evaluation of acute pain and pain-related fear are discussed.",2019,"Participants in the Pain Threat with Control condition self-reported lower effort on cognitive tests, yet no group-based differences were seen in WMT performance.",['Healthy participants ( n = 146) experienced acute pain induced via cold pressor task'],"['pain-related fear: Pain Threat ( n = 36), Pain Threat with Control ( n = 39), Cognitive Threat with Control', 'IGT']","['effort (Word Memory Test [WMT], self-reported effort) and risky decision-making (Iowa Gambling Task [IGT], Balloon Analogue Risk Task [BART', 'risky decisions', 'pain', 'pain-related fear', 'cognitive tests', 'decision-making task performance', 'acute pain and pain-related fear on risky decision-making and effort during cognitive tests', 'WMT performance']","[{'cui': 'C1708335', 'cui_str': 'Healthy Participants'}, {'cui': 'C0184567', 'cui_str': 'Acute Pain'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0444689', 'cui_str': 'Cold pressor test (procedure)'}]","[{'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C2700446', 'cui_str': 'Self-reported (qualifier value)'}, {'cui': 'C0022037', 'cui_str': 'Iowa'}, {'cui': 'C0016995', 'cui_str': 'Gamblings'}, {'cui': 'C0336867', 'cui_str': 'Balloon aircraft (physical object)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0015726', 'cui_str': 'Fear'}, {'cui': 'C0011109', 'cui_str': 'Decision Making'}, {'cui': 'C0039333', 'cui_str': 'Task Performance'}, {'cui': 'C0184567', 'cui_str': 'Acute Pain'}]",,0.0371482,"Participants in the Pain Threat with Control condition self-reported lower effort on cognitive tests, yet no group-based differences were seen in WMT performance.","[{'ForeName': 'Wesley R', 'Initials': 'WR', 'LastName': 'Barnhart', 'Affiliation': 'Nisonger Center, The Ohio State University , Columbus , Ohio , USA.'}, {'ForeName': 'Melissa T', 'Initials': 'MT', 'LastName': 'Buelow', 'Affiliation': 'Department of Psychology, The Ohio State University Newark , Newark , Ohio , USA.'}, {'ForeName': 'Zina', 'Initials': 'Z', 'LastName': 'Trost', 'Affiliation': 'Department of Psychology, University of Alabama at Birmingham , Birmingham , Alabama , USA.'}]",Journal of clinical and experimental neuropsychology,['10.1080/13803395.2019.1646711'] 3301,32067262,"First-in-human study with ACT-539313, a novel selective orexin-1 receptor antagonist.","AIMS The orexin system is involved in anxiety behaviour and corresponding physiological reactions and constitutes a target for treatment of anxiety disorders. ACT-539313 is a potent, selective orexin-1 receptor antagonist being developed for the treatment of anxiety disorders. This first-in-human study investigated its single-dose pharmacokinetics (PK) including food effect, pharmacodynamics (PD), safety and tolerability. METHODS This double-blind, placebo-controlled, randomized study included 40 healthy male subjects. Ascending oral doses of 10-400 mg ACT-539313 were investigated in 5 dose groups of 8 subjects (of whom 2 received placebo per dose group). At 100 mg, subjects received ACT-539313 in fasted and fed conditions in a fixed sequential design. PK, PD (objective and subjective measures of sedation and effects on central nervous system), safety and tolerability were assessed. RESULTS In fasted conditions, ACT-539313 was rapidly absorbed (median time to maximum plasma concentration [C max ] 0.7-3.5 h) and cleared from plasma with a mean terminal half-life of 3.3-5.7 h across dose levels. A 1.63-fold (90% confidence interval: 1.26-2.11) increase in C max and no change in area under the concentration-time curve extrapolated to infinity was observed under fed compared to fasted conditions. No relevant PD signals were detected except for a trend of reduced saccadic peak velocity around time to C max . The most commonly reported adverse events were somnolence and headache. All adverse events were transient and of mild or moderate intensity. No treatment-related effects on vital signs, clinical laboratory or 12-lead electrocardiogram were observed. CONCLUSIONS ACT-539313 exhibits good safety and tolerability at single doses of up to and including 400 mg that warrant further investigations.",2020,"No treatment-related effects on vital signs, clinical laboratory, and 12-lead electrocardiogram (ECG) were observed. ",['40 healthy male subjects'],"['placebo', 'ACT-539313']","['food effect, pharmacodynamics (PD), safety, and tolerability', 'somnolence and headache', 'vital signs, clinical laboratory, and 12-lead electrocardiogram (ECG', 'saccadic peak velocity', 'C max and no change in AUC 0-inf', 'safety and tolerability', 'PK, PD (objective and subjective measures of sedation and effects on central nervous system), safety, and tolerability']","[{'cui': 'C0086582', 'cui_str': 'Males'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0016452', 'cui_str': 'Food'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0243145', 'cui_str': 'pharmacodynamics'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C2830004', 'cui_str': 'Somnolence'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C0518766'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0022877', 'cui_str': 'Laboratory'}, {'cui': 'C0430456', 'cui_str': '12 lead ECG'}, {'cui': 'C1623258', 'cui_str': 'ECG'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C0442739', 'cui_str': 'Id status quo'}, {'cui': 'C0376690', 'cui_str': 'AUC'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0439655', 'cui_str': 'Subjective observation'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0235195', 'cui_str': 'Sedated (finding)'}, {'cui': 'C3540014', 'cui_str': 'CENTRAL NERVOUS SYSTEM'}]",40.0,0.258047,"No treatment-related effects on vital signs, clinical laboratory, and 12-lead electrocardiogram (ECG) were observed. ","[{'ForeName': 'Priska', 'Initials': 'P', 'LastName': 'Kaufmann', 'Affiliation': 'Department of Clinical Pharmacology, Idorsia Pharmaceuticals Ltd, Allschwil, Switzerland.'}, {'ForeName': 'Marion', 'Initials': 'M', 'LastName': 'Ort', 'Affiliation': 'Department of Clinical Pharmacology, Idorsia Pharmaceuticals Ltd, Allschwil, Switzerland.'}, {'ForeName': 'Georg', 'Initials': 'G', 'LastName': 'Golor', 'Affiliation': 'Parexel International GmbH, Berlin, Germany.'}, {'ForeName': 'Rüdiger', 'Initials': 'R', 'LastName': 'Kornberger', 'Affiliation': 'Parexel International GmbH, Berlin, Germany.'}, {'ForeName': 'Jasper', 'Initials': 'J', 'LastName': 'Dingemanse', 'Affiliation': 'Department of Clinical Pharmacology, Idorsia Pharmaceuticals Ltd, Allschwil, Switzerland.'}]",British journal of clinical pharmacology,['10.1111/bcp.14251'] 3302,31806533,"Using immersive virtual reality to improve the beliefs and intentions of influenza vaccine avoidant 18-to-49-year-olds: Considerations, effects, and lessons learned.","OBJECTIVE Only one-third of adults 18-49 years old in the United States receive a recommended annual influenza vaccination. This study examined whether supplementing vaccine information statements (VIS) with an immersive virtual reality (VR), short video or electronic pamphlet story designed to convey the community immunity benefits of influenza vaccination would improve influenza vaccine avoidant participants' influenza-related perceptions as well as their influenza vaccination-related beliefs, confidence and intentions. METHOD A one-way between-subjects experimental design compared the effects of adding a supplemental education experience prior to VIS exposure with flu vaccine avoidant 18-to-49-year-olds. The 171 participants recruited from the community were randomly assigned to one of three modality treatment conditions [VR, video, or e-pamphlet (i.e., story board presented via electronic tablet)] or a VIS-only control condition. RESULTS Compared to the modalities, the VR intervention created a stronger perception of presence (i.e., feeling of ""being there"" in the story), which, in turn, increased participants' concern about transmitting influenza to others and raised vaccination intention. Increased concern about transmitting influenza to others was associated with positive effects on influenza vaccination-related beliefs, including confidence that one's flu vaccination would protect others. Neither the e-pamphlet nor the video intervention were able to elicit a sense of presence nor were they able to improve the impact of the VIS on the outcome measures. CONCLUSIONS Immersive VR has much potential to increase understanding of key immunization concepts, such as community immunity, through creative executions that increase a sense of presence. Given the need to increase influenza vaccination uptake among 18-to-49-year-olds, and the projected growth in VR accessibility and use, additional applications and assessments related to vaccination communication and education are needed and warranted. By increasing the ability to convey key vaccine and immunization concepts, immersive VR could help address vaccination hesitancy and acceptance challenges.",2020,"Neither the e-pamphlet nor the video intervention were able to elicit a sense of presence nor were they able to improve the impact of the VIS on the outcome measures. ","['adults 18-49\u202fyears old in the United States receive a recommended', '171 participants recruited from the community']","['annual influenza vaccination', 'modality treatment conditions [VR, video, or e-pamphlet (i.e., story board presented via electronic tablet)] or a VIS-only control condition', 'supplementing vaccine information statements (VIS) with an immersive virtual reality (VR), short video or electronic pamphlet story', 'supplemental education experience prior to VIS exposure with flu vaccine avoidant 18-to-49-year-olds']",['influenza vaccination uptake'],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0009462', 'cui_str': 'Community'}]","[{'cui': 'C0332181', 'cui_str': 'Annual (qualifier value)'}, {'cui': 'C0042200', 'cui_str': 'Influenza vaccination (procedure)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}, {'cui': 'C0042655', 'cui_str': 'Videotapes'}, {'cui': 'C0030258', 'cui_str': 'Booklets'}, {'cui': 'C0150312', 'cui_str': 'Present (qualifier value)'}, {'cui': 'C4281784', 'cui_str': 'Electronics'}, {'cui': 'C1705223', 'cui_str': 'Tablet'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0042210', 'cui_str': 'Vaccines'}, {'cui': 'C0871582', 'cui_str': 'Virtual Reality'}, {'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0013621', 'cui_str': 'Education'}, {'cui': 'C0332152', 'cui_str': 'Before (attribute)'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0021403', 'cui_str': 'Influenza Vaccines'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}]","[{'cui': 'C0042200', 'cui_str': 'Influenza vaccination (procedure)'}]",171.0,0.0202665,"Neither the e-pamphlet nor the video intervention were able to elicit a sense of presence nor were they able to improve the impact of the VIS on the outcome measures. ","[{'ForeName': 'Glen J', 'Initials': 'GJ', 'LastName': 'Nowak', 'Affiliation': 'Center for Health and Risk Communications and Department of Advertising and Public Relations, Grady College of Journalism and Mass Communication, University of Georgia, Athens, GA 30602, United States. Electronic address: gnowak@uga.edu.'}, {'ForeName': 'Nathaniel J', 'Initials': 'NJ', 'LastName': 'Evans', 'Affiliation': 'Center for Health and Risk Communications and Department of Advertising and Public Relations, Grady College of Journalism and Mass Communication, University of Georgia, Athens, GA 30602, United States.'}, {'ForeName': 'Bartosz W', 'Initials': 'BW', 'LastName': 'Wojdynski', 'Affiliation': 'Center for Health and Risk Communications and Department of Journalism, Grady College of Journalism and Mass Communication, University of Georgia, Athens, GA 30602, United States.'}, {'ForeName': 'Sun Joo Grace', 'Initials': 'SJG', 'LastName': 'Ahn', 'Affiliation': 'Center for Health and Risk Communications and Department of Advertising and Public Relations, Grady College of Journalism and Mass Communication, University of Georgia, Athens, GA 30602, United States.'}, {'ForeName': 'Maria E', 'Initials': 'ME', 'LastName': 'Len-Rios', 'Affiliation': 'Center for Health and Risk Communications and Department of Advertising and Public Relations, Grady College of Journalism and Mass Communication, University of Georgia, Athens, GA 30602, United States.'}, {'ForeName': 'Karen', 'Initials': 'K', 'LastName': 'Carera', 'Affiliation': 'Oak Ridge Associated Universities, 100 Orau Way, Oak Ridge, TN 37830, United States.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Hale', 'Affiliation': 'Oak Ridge Associated Universities, 100 Orau Way, Oak Ridge, TN 37830, United States.'}, {'ForeName': 'Deborah', 'Initials': 'D', 'LastName': 'McFalls', 'Affiliation': 'Oak Ridge Associated Universities, 100 Orau Way, Oak Ridge, TN 37830, United States.'}]",Vaccine,['10.1016/j.vaccine.2019.11.009'] 3303,31376950,Service through surgery: A quasi-experimental comparison study on the impact of a preclinical seminar course on diverse mentorship and attitudes towards the underserved.,"BACKGROUND Increased surgical workforce diversity diminishes health disparities. METHODS Researchers recruited and nonrandomly enrolled participants into intervention and comparison groups for a quasi-experimental study of the impact of a seminar course on student exposure to diverse mentorship and service through surgery. All metrics were analyzed with chi-squared and paired t-tests. RESULTS 109 students participated (34 intervention, 75 comparison). There were significant differences in the percentage of participants that newly met a surgeon of their race (intervention, comparison: 100%, 25%), their race and gender (80%, 21%), their religion (23%, 9%), and who completed health disparities research (90%, 45%, p-value for all <0.05). There was a nonsignificant change in participants' attitudes towards underserved populations in intervention and comparison groups. CONCLUSIONS This preclinical surgery seminar course increased exposure of underrepresented students to surgeons from diverse backgrounds and may impact student attitudes towards the underserved. This class represents a replicable model for increasing mentorship.",2020,"There was a nonsignificant change in participants' attitudes towards underserved populations in intervention and comparison groups. ","['diverse mentorship and attitudes towards the underserved', 'Researchers recruited and nonrandomly enrolled participants into intervention and comparison groups for a quasi-experimental study of the impact of a seminar course on student exposure to diverse mentorship and service through surgery', 'Service through surgery', '109 students participated (34 intervention, 75 comparison']",[],['completed health disparities research'],"[{'cui': 'C0025370', 'cui_str': 'Mentorships'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0035173', 'cui_str': 'Investigators'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C2985410', 'cui_str': 'Clinical Trials, Nonrandomized'}, {'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0750729', 'cui_str': 'Courses (qualifier value)'}, {'cui': 'C0038492', 'cui_str': 'Student (occupation)'}, {'cui': 'C0332157', 'cui_str': 'Exposure to (contextual qualifier) (qualifier value)'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]",[],"[{'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0035168'}]",75.0,0.0238153,"There was a nonsignificant change in participants' attitudes towards underserved populations in intervention and comparison groups. ","[{'ForeName': 'Jecca Rhea', 'Initials': 'JR', 'LastName': 'Steinberg', 'Affiliation': 'Stanford School of Medicine, 291 Campus Drive, Stanford, CA, 94305, USA. Electronic address: jeccasteinberg@gmail.com.'}, {'ForeName': 'Tyler S', 'Initials': 'TS', 'LastName': 'Bryant', 'Affiliation': 'Stanford School of Medicine, 291 Campus Drive, Stanford, CA, 94305, USA. Electronic address: tsbryant@stanford.edu.'}, {'ForeName': 'Anna L', 'Initials': 'AL', 'LastName': 'Carroll', 'Affiliation': 'Stanford School of Medicine, 291 Campus Drive, Stanford, CA, 94305, USA. Electronic address: annac12@stanford.edu.'}, {'ForeName': 'Paloma', 'Initials': 'P', 'LastName': 'Marin-Nevarez', 'Affiliation': 'Stanford School of Medicine, 291 Campus Drive, Stanford, CA, 94305, USA. Electronic address: pmarinne@stanford.edu.'}, {'ForeName': 'Edmund W', 'Initials': 'EW', 'LastName': 'Lee', 'Affiliation': 'Stanford School of Medicine, 291 Campus Drive, Stanford, CA, 94305, USA; Stanford Surgery ACS Education Institute/Goodman Surgical Education Center, Stanford Department of Surgery, 300 Pasteur Drive, Stanford, CA, 94305, USA. Electronic address: EdmundLee12@gmail.com.'}, {'ForeName': 'Tiffany N', 'Initials': 'TN', 'LastName': 'Anderson', 'Affiliation': 'Stanford School of Medicine, 291 Campus Drive, Stanford, CA, 94305, USA; Stanford Surgery ACS Education Institute/Goodman Surgical Education Center, Stanford Department of Surgery, 300 Pasteur Drive, Stanford, CA, 94305, USA. Electronic address: tnanders@stanford.edu.'}, {'ForeName': 'Sylvia Bereknyei', 'Initials': 'SB', 'LastName': 'Merrell', 'Affiliation': 'Stanford Surgery ACS Education Institute/Goodman Surgical Education Center, Stanford Department of Surgery, 300 Pasteur Drive, Stanford, CA, 94305, USA; Stanford-Surgery Policy Improvement Research and Education Center (S-SPIRE), Stanford Department of Surgery, 1070 Arastradero Road, Palo Alto, CA, 94304, USA. Electronic address: sylviab@stanford.edu.'}, {'ForeName': 'James N', 'Initials': 'JN', 'LastName': 'Lau', 'Affiliation': 'Stanford Surgery ACS Education Institute/Goodman Surgical Education Center, Stanford Department of Surgery, 300 Pasteur Drive, Stanford, CA, 94305, USA. Electronic address: jnlau@stanford.edu.'}]",American journal of surgery,['10.1016/j.amjsurg.2019.07.031'] 3304,31031095,Music Tuned to 440 Hz Versus 432 Hz and the Health Effects: A Double-blind Cross-over Pilot Study.,"CONTEXT The current reference frequency for tuning musical instruments is 440 Hz. Some theorists and musicians claim that the 432 Hz tuning has better effects on the human body, but there are no scientific studies that support this hypothesis. OBJECTIVE To identify differences in vital parameters and perceptions after listening to music at different frequencies, 440 Hz versus 432 Hz. DESIGN Cross-over pilot study. SETTING A room dedicated to listening to music, in an Italian city. PARTICIPANTS 33 volunteers, not suffering from acute and/or chronic diseases. INTERVENTIONS Two sessions of music listening on different days. Both sessions used the same music (movie soundtracks) but tuned to 440 Hz on one day and 432 Hz on the other. Each session consisted of 20 min' listening. MAIN OUTCOME MEASURES Vital parameters (blood pressure, heart rate, respiratory rate, oxygen saturation), perceptions (physical and emotional sensations, for example fatigue and stress), levels of concentration during the listening session, and general satisfaction with the experience. RESULTS 432 Hz tuned music was associated with a slight decrease of mean (systolic and diastolic) blood pressure values (although not significant), a marked decrease in the mean of heart rate (-4.79 bpm, p = 0.05) and a slight decrease of the mean respiratory rate values (1 r.a., p = 0.06), compared to 440 Hz. The subjects were more focused about listening to music and more generally satisfied after the sessions in which they listened to 432 Hz tuned music. CONCLUSIONS The data suggests that 432 Hz tuned music can decrease heart rate more than 440 Hz tuned music. The study results suggest repeating the experiment with a larger sample pool and introducing randomized controlled trials covering more clinical parameters.",2019,"Hz tuned music was associated with a slight decrease of mean (systolic and diastolic) blood pressure values (although not significant), a marked decrease in the mean of heart rate (-4.79 bpm, p = 0.05) and a slight decrease of the mean respiratory rate values (1 r.a., p = 0.06), compared to 440 Hz.","['33 volunteers, not suffering from acute and/or chronic diseases', 'A room dedicated to listening to music, in an Italian city', '432']",['music listening'],"['mean (systolic and diastolic) blood pressure values', 'heart rate', 'Vital parameters (blood pressure, heart rate, respiratory rate, oxygen saturation), perceptions (physical and emotional sensations, for example fatigue and stress), levels of concentration during the listening session, and general satisfaction with the experience', 'mean respiratory rate values', 'mean of heart rate']","[{'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C0008679', 'cui_str': 'Chronic Illness'}, {'cui': 'C0004339', 'cui_str': 'Auscultation'}, {'cui': 'C0026867', 'cui_str': 'Music'}, {'cui': 'C0337810', 'cui_str': 'Italians (ethnic group)'}, {'cui': 'C0008848', 'cui_str': 'Cities'}]","[{'cui': 'C0026867', 'cui_str': 'Music'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0005823', 'cui_str': 'Blood Pressure'}, {'cui': 'C1273875', 'cui_str': 'Values (community)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C0442732', 'cui_str': 'Vital (qualifier value)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0231832', 'cui_str': 'Respiration Rate'}, {'cui': 'C0523807', 'cui_str': 'Oximetry'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0205485', 'cui_str': 'Physical (qualifier value)'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0036658', 'cui_str': 'Sensory Function'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}]",33.0,0.145535,"Hz tuned music was associated with a slight decrease of mean (systolic and diastolic) blood pressure values (although not significant), a marked decrease in the mean of heart rate (-4.79 bpm, p = 0.05) and a slight decrease of the mean respiratory rate values (1 r.a., p = 0.06), compared to 440 Hz.","[{'ForeName': 'Diletta', 'Initials': 'D', 'LastName': 'Calamassi', 'Affiliation': 'University of Florence, Italy. Electronic address: diletta.calamassi@gmail.com.'}, {'ForeName': 'Gian Paolo', 'Initials': 'GP', 'LastName': 'Pomponi', 'Affiliation': 'Independent musician, Italy.'}]","Explore (New York, N.Y.)",['10.1016/j.explore.2019.04.001'] 3305,31352853,A quality-of-life mapping function developed from a grass pollen sublingual immunotherapy trial to a tree pollen sublingual immunotherapy trial.,"Aims: Allergic rhinitis is caused by sensitivity to environmental allergens that can significantly impact quality-of-life. The objective of this analysis was to estimate health state utilities and quality-adjusted life days (QALDs) for a tree allergy immunotherapy trial, TT-04 (EudraCT No.2015-004821-15). Health-state utilities are a measure of patient preference for health states and are necessary to derive QALDs for cost-utility analysis. Preference-based utilities were not collected in the TT-04 trial, so a mapping algorithm was developed based on a similar grass allergy immunotherapy trial, GT-08 (EudraCT No. 2004-000083-27), to estimate utilities. Methods: A two-part model was developed to predict utilities for the GT-08 trial and applied to the TT-04 trial to estimate the difference in mean utility and QALDs between SQ tree sublingual immunotherapy (SLIT)-tablet and placebo. Results: Mean utility difference between SQ tree SLIT-tablet and placebo was 0.030 [95% CI = 0.015-0.046] during the birch pollen season (BPS), 0.019 [95% CI = 0.007-0.030] during the tree pollen season (TPS) and 0.018 [95% CI = 0.007-0.030] during the full trial. The treatment showed a QALD benefit of 1.26 [95% CI = 0.619-1.917] during the BPS, 1.90 [95% CI = 0.692-3.047] during the TPS, and 2.47 [95% CI = 0.930-4.101] during the full trial. Limitations: The generalizability of this algorithm is limited to allergy trials containing the same covariates as those present in the model. The analysis also assumes that grass and tree pollen allergy have the same relationship with EQ5D utilities, which is supported by the fact that both grass and tree pollen induce similar symptoms. Conclusions: Application of the mapping function enabled the calculation of QALDs associated with the treatment, with the caveat that data were extrapolated from grass seasonal allergy to tree seasonal allergy. The results showed a significant QALD benefit of the treatment over placebo in treatment of tree pollen-induced rhinoconjunctivitis.",2020,The results showed a significant QALD benefit of the treatment over placebo in treatment of tree pollen-induced rhinoconjunctivitis.,[],"['placebo', 'GT-08']","['mean utility and QALDs', 'tree pollen-induced rhinoconjunctivitis', 'Mean utility difference', 'QALD benefit', 'health state utilities and quality-adjusted life days (QALDs']",[],"[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C3541399', 'cui_str': 'tree pollen allergenic extracts'}, {'cui': 'C0205263', 'cui_str': 'Induced (qualifier value)'}, {'cui': 'C0861155', 'cui_str': 'Rhinoconjunctivitis'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0332306', 'cui_str': 'With quality (attribute)'}, {'cui': 'C0376558', 'cui_str': 'Life'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}]",,0.186921,The results showed a significant QALD benefit of the treatment over placebo in treatment of tree pollen-induced rhinoconjunctivitis.,"[{'ForeName': 'Katherine', 'Initials': 'K', 'LastName': 'Dick', 'Affiliation': 'Avalon Health Economics, Morristown, NJ, USA.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Briggs', 'Affiliation': 'Avalon Health Economics, Morristown, NJ, USA.'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Ohsfeldt', 'Affiliation': 'Avalon Health Economics, Morristown, NJ, USA.'}, {'ForeName': 'Tobias', 'Initials': 'T', 'LastName': 'Sydendal Grand', 'Affiliation': 'ALK, Global Market Access, Hørsholm, Denmark.'}, {'ForeName': 'Sarah', 'Initials': 'S', 'LastName': 'Buchs', 'Affiliation': 'ALK, Global Market Access, Hørsholm, Denmark.'}]",Journal of medical economics,['10.1080/13696998.2019.1649268'] 3306,31433259,A Smartphone App to Facilitate Remote Patient-Provider Communication in Hearing Health Care: Usability and Effect on Hearing Aid Outcomes.,"Background: Patients often need multiple fine-tuning appointments with their hearing health care provider to achieve satisfactory hearing aid outcomes. A smartphone app that enables patients to remotely request and receive new hearing aid settings could improve hearing health care access and efficiency. Introduction: We assessed the usability of ReSound Assist™, (ReSound America, Bloomington, MN) the remote communication feature of a hearing aid app, and investigated whether hearing aid outcomes are influenced by app-based versus in-person patient-provider communication. Materials and Methods: Thirty adults were fit bilaterally with hearing aids and randomized to intervention and control groups. During a 6-week field trial, participants reported hearing aid problems via ReSound Assist (intervention) or at a scheduled face-to-face follow-up appointment (control). Usability of ReSound Assist was assessed with a questionnaire and interview. Hearing aid performance, benefit, satisfaction, and daily usage were compared for both groups. Results: ReSound Assist was rated as highly usable. Participants identified specific aspects of effectiveness and efficiency that could be improved. Similar problems were reported by intervention and control participants regardless of communication mode (app-based vs. in-person). However, almost half the requests received via ReSound Assist were for problems that required advice from the provider or physical modifications to the hearing aids rather than fine-tuning, highlighting the continued importance of in-person hearing health care. There was no significant difference in hearing aid outcomes between intervention and control participants. Conclusions: Apps enabling remote patient-provider communication are a viable method for hearing aid users to seek and receive help with hearing aid problems that can be addressed through fine-tuning.",2020,A smartphone app that enables patients to remotely request and receive new hearing aid settings could improve hearing health care access and efficiency. ,"['participants reported hearing aid problems via ReSound Assist (intervention) or at a scheduled face-to-face follow-up appointment (control', 'Thirty adults']",[],"['Hearing aid performance, benefit, satisfaction, and daily usage', 'hearing aid outcomes']","[{'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C1272118', 'cui_str': 'Hearing aid problem'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0538263', 'cui_str': 'fatty acid 2-chloroethyl ester synthase'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0003629', 'cui_str': 'Appointments'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C3816446', 'cui_str': '30'}, {'cui': 'C0001675', 'cui_str': 'Adult'}]",[],"[{'cui': 'C0018768', 'cui_str': 'Hearing Aids'}, {'cui': 'C0242428', 'cui_str': 'Satisfaction'}, {'cui': 'C0332173', 'cui_str': 'Daily (qualifier value)'}, {'cui': 'C0457083', 'cui_str': 'Usage (attribute)'}]",30.0,0.033924,A smartphone app that enables patients to remotely request and receive new hearing aid settings could improve hearing health care access and efficiency. ,"[{'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Convery', 'Affiliation': 'National Acoustic Laboratories, Sydney, Australia.'}, {'ForeName': 'Gitte', 'Initials': 'G', 'LastName': 'Keidser', 'Affiliation': 'National Acoustic Laboratories, Sydney, Australia.'}, {'ForeName': 'Margot', 'Initials': 'M', 'LastName': 'McLelland', 'Affiliation': 'National Acoustic Laboratories, Sydney, Australia.'}, {'ForeName': 'Jennifer', 'Initials': 'J', 'LastName': 'Groth', 'Affiliation': 'GN Hearing, Glenview, Illinois, USA.'}]",Telemedicine journal and e-health : the official journal of the American Telemedicine Association,['10.1089/tmj.2019.0109'] 3307,31721327,"Safety and efficacy of topical, fixed-dose combination calcipotriene (0.005%) and betamethasone (0.064% as dipropionate) gel in adolescent patients with scalp and body psoriasis: a phase II trial.","BACKGROUND Psoriasis is a disease that commonly manifests in adolescence. Up to half of adults with psoriasis develop it before the age of 20. Topical formulations containing corticosteroids and/or vitamin D3 analogs are recommended for treatment. OBJECTIVE This phase II study aimed to evaluate the safety, including any potential effect on the hypothalamic-pituitary-adrenal axis and calcium metabolism, and efficacy of fixed-dose combination calcipotriene (0.005%) and betamethasone (0.064% as dipropionate) (Cal/BD) gel in adolescents with psoriasis. METHODS Patients aged 12 to <17 years, with at least mild psoriasis on the body and scalp, received topical Cal/BD gel once daily for ≤8 weeks. Safety response criteria included adverse drug reactions [ADRs; any adverse event (AE) possibly or probably related to treatment as determined by the investigator; a primary response criterion] and AEs (a secondary response criterion). Only treatment-emergent AEs (events that occurred after the first application of Cal/BD gel or events which started before this and increased in intensity after the first application of Cal/BD gel) are presented here. Efficacy response criteria included controlled disease, by physician's global assessment of disease severity (PGA), following Cal/BD gel treatment. RESULTS A total of 107 patients (median age 14 years; range 12-16) were enrolled and treated. Eight ADRs were observed in 7 (7%) patients and 38 (36%) patients experienced ≥1 AE. The most common AEs were headache [6 (6%) patients], nasopharyngitis [6 (6%) patients] and blood parathyroid hormone increased [4 (4%) patients]. One severe AE was reported (attempted suicide) but was considered unrelated to treatment. At the end of treatment, 58% of patients had controlled disease on the body and 69% on the scalp according to PGA. CONCLUSION In this uncontrolled phase II study, Cal/BD gel was well tolerated and effective for treating scalp and body psoriasis in adolescents.",2020,"At the end of treatment, 58% of patients had controlled disease on the body and 69% on the scalp according to PGA","['adolescents', 'adolescents with psoriasis', '107 patients (median age 14 years; range 12-16', 'adolescent patients with scalp and body psoriasis', 'Patients aged 12 to <17 years, with at least mild psoriasis on the body and scalp received', 'once daily for ≤8 weeks']","['topical, fixed-dose combination calcipotriene', 'dipropionate', 'Cal/BD gel', 'PGA', 'corticosteroids and/or vitamin D3 analogs', 'betamethasone', 'fixed-dose combination calcipotriene', 'dipropionate) gel', 'topical Cal/BD gel']","['adverse drug reactions (ADRs; any adverse event [AE', 'Safety and efficacy', 'Eight ADRs', 'nasopharyngitis', 'headache', 'tolerated and effective', 'blood parathyroid hormone']","[{'cui': 'C0205653', 'cui_str': 'Adolescent'}, {'cui': 'C0033860', 'cui_str': 'Psoriasis'}, {'cui': 'C4517529', 'cui_str': 'One hundred and seven'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0036270', 'cui_str': 'Scalp'}, {'cui': 'C2945599', 'cui_str': 'Mild (qualifier value)'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}]","[{'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0443218', 'cui_str': 'Fixed (qualifier value)'}, {'cui': 'C0869039', 'cui_str': 'Unit dose'}, {'cui': 'C0065767', 'cui_str': 'calcipotriol'}, {'cui': 'C1879985', 'cui_str': 'calorie'}, {'cui': 'C0017243', 'cui_str': 'Gel (basic dose form)'}, {'cui': 'C0085409', 'cui_str': 'Polyendocrinopathies, Autoimmune'}, {'cui': 'C3265062', 'cui_str': 'vitamin D3'}, {'cui': 'C0005308', 'cui_str': 'Betamethasone'}]","[{'cui': 'C0041755', 'cui_str': 'Drug Side Effects'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0027441', 'cui_str': 'Nasopharyngitis'}, {'cui': 'C0018681', 'cui_str': 'Cephalodynia'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C0853132', 'cui_str': 'Blood parathyroid hormone'}]",107.0,0.0384445,"At the end of treatment, 58% of patients had controlled disease on the body and 69% on the scalp according to PGA","[{'ForeName': 'L F', 'Initials': 'LF', 'LastName': 'Eichenfield', 'Affiliation': ""University of California, San Diego and Rady Children's Hospital, San Diego, CA, USA.""}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Marcoux', 'Affiliation': 'Sainte-Justine University Hospital Center, Montreal, QC, Canada.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Kurvits', 'Affiliation': 'LEO Pharma A/S, Ballerup, Denmark.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Liljedahl', 'Affiliation': 'LEO Pharma A/S, Ballerup, Denmark.'}]",Journal of the European Academy of Dermatology and Venereology : JEADV,['10.1111/jdv.16077'] 3308,31013264,Ultrasound-Guided Femoral Arterial Cannulation in Neonates Undergoing Cardiac Surgery or Catheterization: Comparison of 0.014-Inch Floppy Versus 0.019-Inch Straight Guidewire.,"OBJECTIVES Percutaneous femoral artery cannulation can be technically challenging in small infants. DESIGN We designed a prospective randomized trial to compare the use of two different guidewires for femoral arterial cannulation in neonates undergoing cardiac surgery or catheterization. SETTINGS Cardiac ICU in a university hospital. PATIENTS One-hundred twenty-four children were enrolled in this prospective study, with 64 being randomized to the 0.019-inch straight guidewire group and 60 to the 0.014-inch floppy guidewire group. INTERVENTIONS Femoral artery cannulation. MEASUREMENTS AND MAIN RESULTS The study period was limited to 10 minutes at the first site of arterial puncture. The time to complete cannulation, number of successful cannulation on first attempt, number of attempts, and number of successful cannulations were compared. The number of successful cannulations and successful cannulations on first attempt were higher in 0.014-inch floppy guidewire group (p = 0.001; p = 0.002, respectively). The time to complete cannulation was significantly shorter, and the number of attempts was lower in 0.014-inch floppy guidewire group (p = 0.001). Among the neonates less than 2000g, the number of attempts and time to complete cannulation were significantly lower (p < 0.001), and number of successful cannulation on first attempt and number of successful cannulations were significantly higher (p < 0.028; p < 0.001, respectively) in the 0.014-inch floppy guidewire CONCLUSIONS:: Using 0.014-inch floppy guidewire for femoral arterial cannulation in particularly very small neonates provides significant improvement in first attempt success, number of successful cannulations, number of attempts, time to complete cannulation.",2019,"The number of successful cannulations and successful cannulations on first attempt were higher in 0.014-inch floppy guidewire group (p = 0.001; p = 0.002, respectively).","['neonates undergoing cardiac surgery or catheterization', 'One-hundred twenty-four children', 'Cardiac ICU in a university hospital', 'small infants', 'Neonates Undergoing Cardiac Surgery or Catheterization']","['femoral arterial cannulation', 'Floppy Versus 0.019-Inch Straight Guidewire', 'Ultrasound-Guided Femoral Arterial Cannulation', 'Percutaneous femoral artery cannulation', 'straight guidewire group and 60 to the 0.014-inch floppy guidewire group']","['time to complete cannulation, number of successful cannulation on first attempt, number of attempts, and number of successful cannulations', 'number of attempts', 'number of successful cannulation on first attempt and number of successful cannulations', 'number of attempts and time to complete cannulation', 'number of successful cannulations and successful cannulations', 'time to complete cannulation']","[{'cui': 'C0021289', 'cui_str': 'Newborns'}, {'cui': 'C0524727', 'cui_str': 'Surgery, Cardiac'}, {'cui': 'C0007430', 'cui_str': 'Catheterization'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C3715070', 'cui_str': '24 (qualifier value)'}, {'cui': 'C0008059', 'cui_str': 'Child'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0020028', 'cui_str': 'Hospitals, University'}, {'cui': 'C0547044', 'cui_str': 'Lesser (qualifier value)'}, {'cui': 'C0021270', 'cui_str': 'Infant'}]","[{'cui': 'C0015811', 'cui_str': 'Femur'}, {'cui': 'C0007431', 'cui_str': 'Arterial cannula insertion (procedure)'}, {'cui': 'C0857516', 'cui_str': 'Floppy'}, {'cui': 'C0439204', 'cui_str': 'in - inch'}, {'cui': 'C1527360', 'cui_str': 'Heterosexuals'}, {'cui': 'C0220934', 'cui_str': 'ultrasound'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0522523', 'cui_str': 'Percutaneous approach - access (qualifier value)'}, {'cui': 'C0015801', 'cui_str': 'Femoral Artery'}, {'cui': 'C0917707', 'cui_str': 'Cannulation'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0450302', 'cui_str': '0.014""'}]","[{'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0917707', 'cui_str': 'Cannulation'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C1272703', 'cui_str': 'Successful'}]",124.0,0.117255,"The number of successful cannulations and successful cannulations on first attempt were higher in 0.014-inch floppy guidewire group (p = 0.001; p = 0.002, respectively).","[{'ForeName': 'Tugcin Bora', 'Initials': 'TB', 'LastName': 'Polat', 'Affiliation': 'Department of Pediatric Cardiology, Altinbaş University School of Medicine, Istanbul, Turkey.'}]",Pediatric critical care medicine : a journal of the Society of Critical Care Medicine and the World Federation of Pediatric Intensive and Critical Care Societies,['10.1097/PCC.0000000000001916'] 3309,30580460,A randomized controlled proof-of-concept trial of digoxin and furosemide in adults with cutaneous warts.,"BACKGROUND Topical ionic contraviral therapy (ICVT) with digoxin and furosemide inhibits the potassium influx on which DNA viruses rely for replication. Therefore, ICVT was hypothesized to be a potential novel treatment for cutaneous warts. OBJECTIVES To assess the clinical efficacy, safety and tolerability of ICVT in adults with cutaneous warts. The secondary objective was to gain insight into the underlying working mechanism of ICVT. METHODS Treatment with ICVT was assessed for efficacy, safety and tolerability in a single- centre, randomized, double-blind, placebo-controlled phase IIA trial. Eighty adult patients with at least two cutaneous warts (plantar or common) were randomized to one of four treatments: digoxin + furosemide (0·125%), digoxin (0·125%), furosemide (0·125%) or placebo. The gel was administered once daily for 42 consecutive days. Predefined statistical analysis was performed with a mixed-model ancova. The trial was registered at ClinicalTrials.gov with number NCT02333643. RESULTS Wart size and human papillomavirus (HPV) load reduction was achieved in all active treatment groups. A statistically significant reduction in wart diameter of all treated warts was shown in the digoxin + furosemide treatment group vs. placebo (-3·0 mm, 95% confidence interval -4·9 to -1·1, P = 0·002). There was a statistically significant reduction in the HPV load of all treated warts in the digoxin + furosemide group vs. placebo (-94%, 95% confidence interval -100 to -19, P = 0·03). With wart size reduction, histologically and immunohistochemically defined viral characteristics disappeared from partial and total responding warts. CONCLUSIONS This study demonstrates the proof of concept for the efficacy of topical ICVT in adults with cutaneous warts.",2019,"A statistically significant reduction in wart diameter of all treated warts was shown in the digoxin + furosemide treatment group vs. placebo (-3·0 mm, 95% confidence interval -4·9 to -1·1, P = 0·002).","['adults with cutaneous warts', 'Eighty adult patients with at least two cutaneous warts (plantar or common']","['ICVT', 'digoxin and furosemide', 'placebo', 'digoxin + furosemide', 'digoxin + furosemide (0·125%), digoxin (0·125%), furosemide (0·125%) or placebo', 'topical ICVT']","['efficacy, safety and tolerability', 'clinical efficacy, safety and tolerability', 'HPV load', 'Wart size and human papillomavirus (HPV) load reduction']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C4521174', 'cui_str': 'Cutaneous'}, {'cui': 'C3665596', 'cui_str': 'Verruca'}, {'cui': 'C3816958', 'cui_str': 'Eighty'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0442036', 'cui_str': 'Plantar (qualifier value)'}, {'cui': 'C0205214', 'cui_str': 'Common (qualifier value)'}]","[{'cui': 'C0012265', 'cui_str': 'Digoxin'}, {'cui': 'C0016860', 'cui_str': 'Furosemide'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}]","[{'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0087113', 'cui_str': 'Treatment Efficacy'}, {'cui': 'C0445306', 'cui_str': 'Wart size'}, {'cui': 'C0021344', 'cui_str': 'Human Papillomavirus'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}]",80.0,0.66715,"A statistically significant reduction in wart diameter of all treated warts was shown in the digoxin + furosemide treatment group vs. placebo (-3·0 mm, 95% confidence interval -4·9 to -1·1, P = 0·002).","[{'ForeName': 'M', 'Initials': 'M', 'LastName': 'Rijsbergen', 'Affiliation': 'Center for Human Drug Research, Leiden, the Netherlands.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Niemeyer-van der Kolk', 'Affiliation': 'Center for Human Drug Research, Leiden, the Netherlands.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Hogendoorn', 'Affiliation': 'Center for Human Drug Research, Leiden, the Netherlands.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Kouwenhoven', 'Affiliation': 'Department of Dermatology, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'C', 'Initials': 'C', 'LastName': 'Lemoine', 'Affiliation': 'Center for Human Drug Research, Leiden, the Netherlands.'}, {'ForeName': 'E S', 'Initials': 'ES', 'LastName': 'Klaassen', 'Affiliation': 'Center for Human Drug Research, Leiden, the Netherlands.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'de Koning', 'Affiliation': 'DDL Diagnostic Laboratory, Rijswijk, the Netherlands.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Beck', 'Affiliation': 'DDL Diagnostic Laboratory, Rijswijk, the Netherlands.'}, {'ForeName': 'J N', 'Initials': 'JN', 'LastName': 'Bouwes Bavinck', 'Affiliation': 'Department of Dermatology, Leiden University Medical Center, Leiden, the Netherlands.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Feiss', 'Affiliation': 'Cutanea Life Science, Wayne, PA, U.S.A.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Burggraaf', 'Affiliation': 'Center for Human Drug Research, Leiden, the Netherlands.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Rissmann', 'Affiliation': 'Center for Human Drug Research, Leiden, the Netherlands.'}]",The British journal of dermatology,['10.1111/bjd.17583'] 3310,32071129,Physiologic Effects of Nasal Aspiration and Nasopharyngeal Suctioning on Infants With Viral Bronchiolitis.,"BACKGROUND There is limited evidence supporting an optimum method for removing mucus from the airways of hospitalized infants with bronchiolitis. This study was designed to evaluate short-term physiologic effects between nasal aspiration and nasopharyngeal suctioning in infants. METHODS Sixteen infants requiring hospitalization for supportive management of bronchiolitis were instrumented with transcutaneously measured partial pressure of carbon dioxide ([Formula: see text]) and [Formula: see text] monitoring. Electrical impedance tomography (EIT) was used to estimate changes in inspiratory and end-expiratory lung volume loss and recovery. Subjects were suctioned with both nasal aspiration and nasopharyngeal suctioning methods in a randomized order (8 received nasal aspiration followed by nasopharyngeal suctioning, and 8 received nasophayrgeal suctioning followed by nasal aspiration). Noninvasive gas exchange and EIT measurements were obtained at baseline (pre-suction) and at 10, 20, and 30 min following each suctioning intervention. Sputum mass was obtained following suctioning, and clinical respiratory severity scores, before and after suctioning, were computed. RESULTS There were no differences in inspiratory EIT ( P = .93), change in end-expiratory lung impedance (ΔEELI; P = .53), [Formula: see text] ( P = .41), [Formula: see text] ( P = .88), heart rate ( P = .31), or breathing frequency ( P = .15) over the course of suctioning between nasal aspiration and nasopharyngeal suctioning. Sputum mass ( P = .14) and clinical respiratory score differences before and after suctioning ( P = .59) were not different between the 2 suctioning interventions. Sputum mass was not associated with ΔEELI at 30 min for nasal aspiration (ρ = 0.11, P = .69), but there was a moderate positive association for nasopharyngeal suctioning (ρ = 0.50, P = .048). CONCLUSIONS Infants with viral bronchiolitis appeared to tolerate both suctioning techniques without adverse short-term physiologic effects, as indicated by the unchanged gas exchange and estimated lung volumes (EIT). Nasopharyngeal suctioning recovered 36% more sputum than did nasal aspiration and there was moderate correlation between sputum mass and end-expiratory lung impedance change at 30 minutes post-suction with nasopharyngeal that was not present with nasal aspiration. It is possible that a subset of patients may benefit from one type of suctioning over another. Future research focusing on important outcomes for suctioning patients with bronchiolitis with varying degrees of lung disease severity is needed.",2020,"There were no differences in inspiratory EIT ( P = .93), change in end-expiratory lung impedance (ΔEELI; P = .53), P tcCO 2 ( P = .41), S","['Sixteen infants requiring hospitalization for supportive management of bronchiolitis were instrumented with', 'Infants with viral bronchiolitis', 'Infants With Viral Bronchiolitis', 'infants', 'suctioning patients with bronchiolitis with varying degrees of lung disease severity', 'hospitalized infants with bronchiolitis']","['nasal aspiration and nasopharyngeal suctioning methods', 'transcutaneously measured partial pressure of carbon dioxide (P tcCO 2 ) and S pO 2 monitoring', 'Electrical impedance tomography (EIT', 'Nasal Aspiration and Nasopharyngeal Suctioning', 'nasal aspiration followed by nasopharyngeal suctioning, and 8 received nasophayrgeal suctioning followed by nasal aspiration', 'nasal aspiration and nasopharyngeal suctioning']","['moderate positive association for nasopharyngeal suctioning', 'inspiratory EIT', 'sputum mass and end-expiratory lung impedance change', 'change in end-expiratory lung impedance', 'Nasopharyngeal suctioning', 'Sputum mass', 'breathing frequency', 'changes in inspiratory and end-expiratory lung volume loss and recovery', 'Noninvasive gas exchange and EIT measurements', 'heart rate']","[{'cui': 'C3715157', 'cui_str': '16'}, {'cui': 'C0021270', 'cui_str': 'Infant'}, {'cui': 'C0019993', 'cui_str': 'Hospitalization'}, {'cui': 'C0006271', 'cui_str': 'Bronchiolitis'}, {'cui': 'C4551823', 'cui_str': 'instruments'}, {'cui': 'C0006274', 'cui_str': 'Bronchiolitis, Viral'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0449286', 'cui_str': 'Degree (attribute)'}, {'cui': 'C0024115', 'cui_str': 'Pulmonary Diseases'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}]","[{'cui': 'C1142346', 'cui_str': 'Nasal aspiration'}, {'cui': 'C0027442', 'cui_str': 'Rhinopharynx'}, {'cui': 'C0025663', 'cui_str': 'Methods'}, {'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0030604', 'cui_str': 'Partial Pressure'}, {'cui': 'C0007012', 'cui_str': 'Carbon Dioxide'}, {'cui': 'C0297199', 'cui_str': 'PO-2'}, {'cui': 'C0162537', 'cui_str': 'Electrical Impedance'}, {'cui': 'C0040395', 'cui_str': 'Tomographic imaging'}, {'cui': 'C0332283', 'cui_str': 'Followed by (attribute)'}]","[{'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C1446409', 'cui_str': 'Positive (qualifier value)'}, {'cui': 'C0004083', 'cui_str': 'Association'}, {'cui': 'C0027442', 'cui_str': 'Rhinopharynx'}, {'cui': 'C0004048', 'cui_str': 'Inhalation'}, {'cui': 'C0038056', 'cui_str': 'Sputum'}, {'cui': 'C1306372', 'cui_str': 'Mass, a measure of quantity of matter (property) (qualifier value)'}, {'cui': 'C0442700', 'cui_str': 'End-expiration'}, {'cui': 'C0024109', 'cui_str': 'Lung'}, {'cui': 'C0162537', 'cui_str': 'Electrical Impedance'}, {'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0231953', 'cui_str': 'Lung volume, function (observable entity)'}, {'cui': 'C0596601', 'cui_str': 'Gas'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}]",16.0,0.0441428,"There were no differences in inspiratory EIT ( P = .93), change in end-expiratory lung impedance (ΔEELI; P = .53), P tcCO 2 ( P = .41), S","[{'ForeName': 'Coral N', 'Initials': 'CN', 'LastName': 'Ringer', 'Affiliation': ""Clinical Effectiveness, Quality and Safety Support, Seattle Children's Hospital, Seattle, Washington. coral.ringer@seattlechildrens.org.""}, {'ForeName': 'Rebecca J', 'Initials': 'RJ', 'LastName': 'Engberg', 'Affiliation': ""Pediatric Intensive Care Unit, Seattle Children's Hospital, Seattle, Washington.""}, {'ForeName': 'Kristen E', 'Initials': 'KE', 'LastName': 'Carlin', 'Affiliation': ""Center for Clinical and Translational Research, Seattle Children's Research Institute, Seattle, Washington.""}, {'ForeName': 'Craig D', 'Initials': 'CD', 'LastName': 'Smallwood', 'Affiliation': ""Department of Anesthesiology, Critical Care and Pain Medicine, Boston Children's Hospital, Boston, Massachusetts and Harvard Medical School, Boston, Massachusetts.""}, {'ForeName': 'Robert M', 'Initials': 'RM', 'LastName': 'DiBlasi', 'Affiliation': ""Respiratory Care Department, Seattle Children's Hospital, Seattle, Washington and Center for Integrative Brain Research, Seattle Children's Research Institute, Seattle, Washington.""}]",Respiratory care,['10.4187/respcare.07269'] 3311,30623408,"Efficacy and safety of PAC-14028 cream - a novel, topical, nonsteroidal, selective TRPV1 antagonist in patients with mild-to-moderate atopic dermatitis: a phase IIb randomized trial.","BACKGROUND Transient receptor potential vanilloid subfamily, member 1 (TRPV1) may play an important role in pruritus and inflammation induction in atopic dermatitis (AD). The treatment effect of TRPV1 antagonist via topical application in patients with AD remains unknown. OBJECTIVES To assess the clinical efficacy and safety of PAC-14028, a TRPV1 antagonist, via topical application in patients with AD. METHODS In this 8-week, phase IIb, randomized, double-blind, multicentre, vehicle-controlled study, patients with mild-to-moderate AD were randomized to receive PAC-14028 cream 0·1%, 0·3%, 1·0% or vehicle cream twice daily. The primary efficacy end point was the Investigator's Global Assessment (IGA) success rate defined as the percentage of patients with an IGA score of 0 or 1 at week 8. The secondary efficacy end points included the severity Scoring of Atopic Dermatitis (SCORAD) index and Eczema Area and Severity Index (EASI) 75/90. RESULTS A total of 194 patients were enrolled. IGA success rates at week 8 were 14·58% for vehicle cream, 42·55% for PAC-14028 cream 0·1% (P = 0·0025 vs. vehicle), 38·30% for PAC-14028 cream 0·3% (P = 0·0087 vs. vehicle) and 57·45% for PAC-14028 cream 1·0% (P < 0·001 vs. vehicle). In particular, statistically significant differences were found between the vehicle and treatment groups in the IGA success rates with two-grade improvement. The SCORAD index, EASI 75/90, sleep disturbance score and pruritus visual analogue scale showed a trend towards improvement. No significant safety issues were reported. CONCLUSIONS PAC-14028 cream may be an effective and safe treatment modality for the treatment of patients with mild-to-moderate AD.",2019,"IGA success rates at week 8 were 14·58% for vehicle cream, 42·55% for PAC-14028 cream 0·1% (","['patients with AD remains unknown', 'patients with mild-to-moderate atopic dermatitis', 'atopic dermatitis (AD', '194 patients were enrolled', 'patients with mild-to-moderate AD', 'patients with AD']","['PAC-14028, a TRPV1 antagonist', 'TRPV1 antagonist via topical application', 'PAC-14028 cream - a novel, topical, nonsteroidal, selective TRPV1 antagonist', 'PAC-14028 cream 0·1%, 0·3%, 1·0% or vehicle cream', 'PAC-14028 cream']","['severity Scoring of Atopic Dermatitis (SCORAD) index and Eczema Area and Severity Index', 'effective and safe treatment modality', 'IGA success rates', 'SCORAD index, EASI 75/90, sleep disturbance score and pruritus visual analogue scale', ""Investigator's Global Assessment (IGA) success rate defined as the percentage of patients with an IGA score"", 'Efficacy and safety']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0439673', 'cui_str': 'Unknown (qualifier value)'}, {'cui': 'C1299392', 'cui_str': 'Mild to moderate'}, {'cui': 'C0011615', 'cui_str': 'Neurodermatitis, Disseminated'}]","[{'cui': 'C3177712', 'cui_str': 'PAC-14028'}, {'cui': 'C0243076', 'cui_str': 'antagonists'}, {'cui': 'C0332237', 'cui_str': 'Topical (qualifier value)'}, {'cui': 'C0185125', 'cui_str': 'Application (attribute)'}, {'cui': 'C1378128', 'cui_str': 'Cream'}, {'cui': 'C0042444', 'cui_str': 'Drug vehicle (substance)'}]","[{'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0011615', 'cui_str': 'Neurodermatitis, Disseminated'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0013595', 'cui_str': 'Dermatitis, Eczematous'}, {'cui': 'C0205146', 'cui_str': 'Area (qualifier value)'}, {'cui': 'C1704419', 'cui_str': 'Effective (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0020835', 'cui_str': 'Immunoglobulin A'}, {'cui': 'C0700201', 'cui_str': 'Dyssomnias'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0033774', 'cui_str': 'Pruritis'}, {'cui': 'C3536884', 'cui_str': 'Visual Analog Scale'}, {'cui': 'C0035173', 'cui_str': 'Investigators'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C3539106', 'cui_str': 'Sufficiently defined concept definition status (core metadata concept)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0036043', 'cui_str': 'Safety'}]",194.0,0.135762,"IGA success rates at week 8 were 14·58% for vehicle cream, 42·55% for PAC-14028 cream 0·1% (","[{'ForeName': 'Y W', 'Initials': 'YW', 'LastName': 'Lee', 'Affiliation': 'Department of Dermatology, Konkuk University School of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'C-H', 'Initials': 'CH', 'LastName': 'Won', 'Affiliation': 'Department of Dermatology, Ulsan University College of Medicine, Asan Medical Center, Seoul, Republic of Korea.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Jung', 'Affiliation': 'Vital Beautie Research Institute, AmorePacific Corporation R&D Center, Yongin, Republic of Korea.'}, {'ForeName': 'H-J', 'Initials': 'HJ', 'LastName': 'Nam', 'Affiliation': 'Vital Beautie Research Institute, AmorePacific Corporation R&D Center, Yongin, Republic of Korea.'}, {'ForeName': 'G', 'Initials': 'G', 'LastName': 'Choi', 'Affiliation': 'Vital Beautie Research Institute, AmorePacific Corporation R&D Center, Yongin, Republic of Korea.'}, {'ForeName': 'Y-H', 'Initials': 'YH', 'LastName': 'Park', 'Affiliation': 'Vital Beautie Research Institute, AmorePacific Corporation R&D Center, Yongin, Republic of Korea.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Park', 'Affiliation': 'Vital Beautie Research Institute, AmorePacific Corporation R&D Center, Yongin, Republic of Korea.'}, {'ForeName': 'B', 'Initials': 'B', 'LastName': 'Kim', 'Affiliation': 'Department of Dermatology, Chung-Ang University College of Medicine, Seoul, Republic of Korea.'}]",The British journal of dermatology,['10.1111/bjd.17455'] 3312,31006614,Effect of weight loss on bone metabolism in postmenopausal obese women with osteoarthritis.,"BACKGROUND The choice of hypocaloric diets in obesity can affect bone health. AIMS The aim of this study is to assess the effect of a hypocaloric diet in postmenopausal obese women and to determine the influence of weight reduction on bone metabolism. METHODS This was a non-randomised, single-treatment study in 96 postmenopausal women with a body mass index (BMI) greater than 35kg/m 2 and osteoarthritis. The patients received a formula diet with two intake levels of a normocaloric hyperproteic formula (1035kcal (25% protein)). Anthropometry and biochemistry with CrossLaps, osteocalcin, parathyroid hormone (PTH) and 25-OH vitamin D were measured. Consumption of protein, calcium and vitamin D were determined at the beginning of and 3 and 6 months into the study. The response to treatment was compared (high-responder (HR): weight loss greater than 15%, and low-responder (LR): weight loss less than 15%). RESULTS The mean age was 64.2 (7.5) years. After 6 months of treatment, a weight loss of 10.2% (8.2-13.8) was observed. There was a significant increase in vitamin D (HR: 21.8% (36.2) vs. LR: 22.7% (36.9), p=0.93) and CrossLaps (HR: 26.8% (19.5-35.2)) vs. LR: 13.3% (-6.1 to 27.9), p=0.01). The loss of more than 15% of initial body weight was an independent risk factor for an increase in CrossLaps (OR: 4.22 (1.1-16.8), p=0.04). CONCLUSIONS In postmenopausal obese women, weight loss was associated with an increase in the biochemical parameters of bone resorption. The increase in resorption parameters was related to the magnitude of weight loss.",2019,"The loss of more than 15% of initial body weight was an independent risk factor for an increase in CrossLaps (OR: 4.22 (1.1-16.8), p=0.04). ","['postmenopausal obese women with osteoarthritis', '96 postmenopausal women with a body mass index (BMI) greater than 35kg/m 2 and osteoarthritis', 'The mean age was 64.2 (7.5) years', 'postmenopausal obese women']","['hypocaloric diet', 'hypocaloric diets', 'formula diet with two intake levels of a normocaloric hyperproteic formula (1035kcal (25% protein', 'weight loss']","['vitamin D', 'weight loss', 'Anthropometry and biochemistry with CrossLaps, osteocalcin, parathyroid hormone (PTH) and 25-OH vitamin D', 'Consumption of protein, calcium and vitamin D', 'biochemical parameters of bone resorption', 'bone metabolism', 'resorption parameters']","[{'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0028754', 'cui_str': 'Obesity'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0029408', 'cui_str': 'Arthritis, Degenerative'}, {'cui': 'C0005893', 'cui_str': 'Body mass index'}, {'cui': 'C1704243', 'cui_str': 'Greater (qualifier value)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517859', 'cui_str': 'Seven point five'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0012155', 'cui_str': 'Diet'}, {'cui': 'C0012164'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}]","[{'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C1262477', 'cui_str': 'Weight Reduction'}, {'cui': 'C0003188', 'cui_str': 'Anthropometry'}, {'cui': 'C0005477', 'cui_str': 'Biochemistry'}, {'cui': 'C0671677', 'cui_str': 'CrossLaps peptide'}, {'cui': 'C0373691', 'cui_str': 'Osteocalcin measurement (procedure)'}, {'cui': 'C0030520', 'cui_str': 'Parathyroid Hormone'}, {'cui': 'C0009830', 'cui_str': 'Consumption'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0006675', 'cui_str': 'Calcium'}, {'cui': 'C0205474', 'cui_str': 'Biochemical (qualifier value)'}, {'cui': 'C0449381', 'cui_str': 'Observation parameter'}, {'cui': 'C0005974', 'cui_str': 'Osteoclastic Bone Loss'}, {'cui': 'C0262950', 'cui_str': 'Bones'}, {'cui': 'C0025520', 'cui_str': 'metabolism'}]",96.0,0.0351589,"The loss of more than 15% of initial body weight was an independent risk factor for an increase in CrossLaps (OR: 4.22 (1.1-16.8), p=0.04). ","[{'ForeName': 'Juan José', 'Initials': 'JJ', 'LastName': 'López-Gómez', 'Affiliation': 'Endocrinology and Nutrition Service, Hospital Clínico Universitario de Valladolid, Spain; Investigation Center on Endocrinology and Nutrition (IEN), University of Valladolid, Spain. Electronic address: jjlopez161282@hotmail.com.'}, {'ForeName': 'Olatz', 'Initials': 'O', 'LastName': 'Izaola-Jauregui', 'Affiliation': 'Endocrinology and Nutrition Service, Hospital Clínico Universitario de Valladolid, Spain; Investigation Center on Endocrinology and Nutrition (IEN), University of Valladolid, Spain.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Primo-Martín', 'Affiliation': 'Endocrinology and Nutrition Service, Hospital Clínico Universitario de Valladolid, Spain; Investigation Center on Endocrinology and Nutrition (IEN), University of Valladolid, Spain.'}, {'ForeName': 'Beatriz', 'Initials': 'B', 'LastName': 'Torres-Torres', 'Affiliation': 'Endocrinology and Nutrition Service, Hospital Clínico Universitario de Valladolid, Spain; Investigation Center on Endocrinology and Nutrition (IEN), University of Valladolid, Spain.'}, {'ForeName': 'Emilia', 'Initials': 'E', 'LastName': 'Gómez-Hoyos', 'Affiliation': 'Endocrinology and Nutrition Service, Hospital Clínico Universitario de Valladolid, Spain; Investigation Center on Endocrinology and Nutrition (IEN), University of Valladolid, Spain.'}, {'ForeName': 'Ana', 'Initials': 'A', 'LastName': 'Ortolá-Buigues', 'Affiliation': 'Endocrinology and Nutrition Service, Hospital Clínico Universitario de Valladolid, Spain; Investigation Center on Endocrinology and Nutrition (IEN), University of Valladolid, Spain.'}, {'ForeName': 'Miguel Ángel', 'Initials': 'MÁ', 'LastName': 'Martín-Ferrero', 'Affiliation': 'Traumatology Service, Hospital Clínico Universitario de Valladolid, Spain.'}, {'ForeName': 'José Luis', 'Initials': 'JL', 'LastName': 'Pérez-Castrillón', 'Affiliation': 'Internal Medicine Service, Hospital Universitario Rio Hortega Valladolid, Spain.'}, {'ForeName': 'Daniel A', 'Initials': 'DA', 'LastName': 'De Luis-Román', 'Affiliation': 'Endocrinology and Nutrition Service, Hospital Clínico Universitario de Valladolid, Spain; Investigation Center on Endocrinology and Nutrition (IEN), University of Valladolid, Spain.'}]",Obesity research & clinical practice,['10.1016/j.orcp.2019.03.002'] 3313,30898938,"SENTICOL III: an international validation study of sentinel node biopsy in early cervical cancer. A GINECO, ENGOT, GCIG and multicenter study.","BACKGROUND Radical hysterectomy and complete pelvic lymphadenectomies are the most commonly performed procedures for women with early-stage cervical cancer. Sentinel lymph node (SLN) mapping could be an alternative to routine pelvic lymphadenectomy, aiming to diagnose accurately nodal extension and decrease lymphatic morbidity. PRIMARY OBJECTIVE To compare 3-year disease-free survival and health-related quality of life after SLN biopsy or SLN biopsy + pelvic lymphadenectomy in early cervical cancer. STUDY HYPOTHESIS We hypothesize that disease-free survival is non-inferior and health-related quality of life superior after SLN biopsy compared with SLN biopsy + pelvic lymphadenectomy. TRIAL DESIGN International, randomized, multicenter, single-blind trial. The study will be run by teams trained to carry out SLN biopsy, belonging to clinical research cooperative groups or recognized as experts in this field. Patients with an optimal mapping (Memorial Sloan Kettering Cancer Center [MSKCC] criteria) and a negative frozen section will be randomized 1:1 to SLN biopsy only or SLN biopsy + pelvic lymphadenectomy. INCLUSION, EXCLUSION CRITERIA Patients with early stages (Ia1 with lymphovascular invasion to IIa1) of disease. Histological types are limited to squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma. PRIMARY ENDPOINT Main endpoint will be co-primary endpoint, associating 3-year disease-free survival and quality of life (QLQ-C30 and QLQ-CX24). SAMPLE SIZE 950 patients need to be randomized.Estimated dates for completing accrual and presenting results: study started on Q2 2018, last accrual is scheduled for Q2 2021, and last follow-up in Q2 2026. TRIAL REGISTRATION ClinicalTrials.gov identifier: NCT03386734.",2019,"HYPOTHESIS We hypothesize that disease-free survival is non-inferior and health-related quality of life superior after SLN biopsy compared with SLN biopsy + pelvic lymphadenectomy. ","['Patients with early stages (Ia1 with lymphovascular invasion to IIa1) of disease', 'Patients with an optimal mapping (Memorial Sloan Kettering Cancer Center [MSKCC] criteria) and a negative frozen section', 'women with early-stage cervical cancer', 'in early cervical cancer']","['sentinel node biopsy', 'SLN biopsy + pelvic lymphadenectomy', 'SLN biopsy only or SLN biopsy + pelvic lymphadenectomy', 'SLN biopsy or SLN biopsy + pelvic lymphadenectomy', 'Radical hysterectomy and complete pelvic lymphadenectomies']","['3-year disease-free survival and health-related quality of life', '3-year disease-free survival and quality of life (QLQ-C30 and QLQ-CX24']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C2363430', 'cui_str': 'Early stage (qualifier value)'}, {'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0205099', 'cui_str': 'Central (qualifier value)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0205160', 'cui_str': 'Negative (qualifier value)'}, {'cui': 'C0016741', 'cui_str': 'Frozen Sections'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0007847', 'cui_str': 'Malignant tumor of cervix (disorder)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}]","[{'cui': 'C0796693', 'cui_str': 'Sentinel Lymph Node Biopsy'}, {'cui': 'C0005558', 'cui_str': 'Biopsy'}, {'cui': 'C0193883', 'cui_str': 'Pelvic lymphadenectomy (procedure)'}, {'cui': 'C0439796', 'cui_str': 'Biopsy only (qualifier value)'}, {'cui': 'C2987682', 'cui_str': 'Radical hysterectomy (procedure)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0030797', 'cui_str': 'Pelvic Region'}, {'cui': 'C0024203', 'cui_str': 'Lymphadenectomy'}]","[{'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0242793', 'cui_str': 'Disease-Free Survival'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034380'}]",950.0,0.155854,"HYPOTHESIS We hypothesize that disease-free survival is non-inferior and health-related quality of life superior after SLN biopsy compared with SLN biopsy + pelvic lymphadenectomy. ","[{'ForeName': 'Fabrice R', 'Initials': 'FR', 'LastName': 'Lecuru', 'Affiliation': 'Gynecologic and Oncologic Surgery, GINECO, Georges Pompidou European Hospital, Paris, France fabrice.lecuru@aphp.fr.'}, {'ForeName': 'Mary', 'Initials': 'M', 'LastName': 'McCormack', 'Affiliation': 'NRCI, UK, UCLH London, London, UK.'}, {'ForeName': 'Peter', 'Initials': 'P', 'LastName': 'Hillemanns', 'Affiliation': 'Klinik fur Frauenheilkunde und Geburtshilfe, AGO, Medizinische Hochschule, Hannover, Germany.'}, {'ForeName': 'Amelie', 'Initials': 'A', 'LastName': 'Anota', 'Affiliation': 'Statistics, GINECO, Centre Hospitalier Universitaire de Besancon, Besancon, France.'}, {'ForeName': 'Mario', 'Initials': 'M', 'LastName': 'Leitao', 'Affiliation': 'Gynecologic Oncology, Memorial Sloan-Kettering Cancer Center, New York City, New York, USA.'}, {'ForeName': 'Patrice', 'Initials': 'P', 'LastName': 'Mathevet', 'Affiliation': 'Centre Hospitalier Universitaire Vaudois Departement de gynecologie-obstetrique et genetique medicale, Lausanne, Switzerland.'}, {'ForeName': 'Ronald', 'Initials': 'R', 'LastName': 'Zweemer', 'Affiliation': 'Gynecologic Oncology, DGOG, UMC Utrecht Hersencentrum Rudolf Magnus, Utrecht, UK.'}, {'ForeName': 'Keiichi', 'Initials': 'K', 'LastName': 'Fujiwara', 'Affiliation': 'Gynecologic Oncology, GOTIC, Saitama Medical University, Moroyama, Japan.'}, {'ForeName': 'Vanna', 'Initials': 'V', 'LastName': 'Zanagnolo', 'Affiliation': 'Gynecologic Oncology, MANGO, Istituto Europeo di Oncologia, Milano, Italy.'}, {'ForeName': 'Ane Gerda', 'Initials': 'AG', 'LastName': 'Zahl Eriksson', 'Affiliation': 'Gynecologic Oncology, NSGO, Universitetet i Oslo, Oslo, Norway.'}, {'ForeName': 'Emma', 'Initials': 'E', 'LastName': 'Hudson', 'Affiliation': 'Gynecologic Oncology, NRCI, Velindre Cancer Centre, Cardiff, UK.'}, {'ForeName': 'Gwenael', 'Initials': 'G', 'LastName': 'Ferron', 'Affiliation': 'Gynecologic Oncology, GINECO, Institut Universitaire du Cancer Toulouse Oncopole, Toulouse, France.'}, {'ForeName': 'Marie', 'Initials': 'M', 'LastName': 'Plante', 'Affiliation': 'Gynecologic Oncology, CCTG, Fondation du CHU de Quebec, Quebec City, Quebec, Canada.'}]",International journal of gynecological cancer : official journal of the International Gynecological Cancer Society,['10.1136/ijgc-2019-000332'] 3314,30839302,Plyometric exercise improves jumping performance and skeletal muscle contractile properties in seniors.,"OBJECTIVE This study investigated the effects of an 8-week plyometric training (PT) session on countermovement jump (CMJ) height, take-off velocity, and Tensiomyography (TMG) derived contractile parameters in seniors. METHODS Twenty-three senior adults (age 66.7±5.2 years) were randomly divided into two groups: PLYO (n=11) and CTRL (n=12). Tensiomyography was measured in vastus lateralis (VL), biceps femoris (BF), tibialis anterior (TA), gastrocnemius medialis (GM), and lateralis (GL). Additionally, the electromechanical efficiency (EME) index was calculated in GM as a ratio between amplitudes of peak-to-peak M-wave and TMG (Dm) responses. Biochemical markers of muscle damage and inflammation were evaluated to provide indirect indices of exercise protocol safety. RESULTS The main effect of time (for take-off velocity p=.023; ɳ 2 = .236) and group x time interactions (for CMJ, Tc (BF, GM), Dm (BF) and EME p<.05; ɳ 2 = .136 - .236) were observed. Post hoc analysis showed a significant increase in CMJ height and take-off velocity, namely by 14.2% (p=.001) and 8.2% (p=.01) in PLYO, respectively. Contraction time (Tc) decreased in BF -5.7% (p=.001) and GM -9.6% (p=.001). Dm decreased only in BF -20.8% (p=.001), while the EME index of the GM improved by 22.9% (p=.002). There were no differences between groups or assessment time points for C-reactive protein (p=.122). CONCLUSION The present study clearly supports the application of supervised PT exercise in seniors, since explosive power, muscle contractility, and EME of the lower limbs were markedly improved after training.",2019,"The main effect of time (for take-off velocity p=.023; ɳ 2 = .236) and group x time interactions (for CMJ, Tc (BF, GM), Dm (BF) and EME p<.05;","['seniors', 'Twenty-three senior adults (age 66.7±5.2 years']","['supervised PT exercise', '8-week plyometric training (PT) session', 'Tensiomyography', 'Plyometric exercise', 'CTRL']","['electromechanical efficiency (EME) index', 'vastus lateralis (VL), biceps femoris (BF), tibialis anterior (TA), gastrocnemius medialis (GM), and lateralis (GL', 'CMJ height and take-off velocity', 'jumping performance and skeletal muscle contractile properties', 'Dm', 'Contraction time (Tc', 'EME index of the GM', 'countermovement jump (CMJ) height, take-off velocity, and Tensiomyography (TMG', 'time interactions (for CMJ, Tc (BF, GM), Dm (BF) and EME p<.05']","[{'cui': 'C0450348', 'cui_str': '23 (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C3178799', 'cui_str': 'Plyometric Training'}]","[{'cui': 'C0013682', 'cui_str': 'Efficiency'}, {'cui': 'C0600653', 'cui_str': 'Indexes'}, {'cui': 'C0205094', 'cui_str': 'Anterior (qualifier value)'}, {'cui': 'C0439830', 'cui_str': 'Velocity (property) (qualifier value)'}, {'cui': 'C0560453', 'cui_str': 'Does jump (finding)'}, {'cui': 'C0242692', 'cui_str': 'Muscle, Voluntary'}, {'cui': 'C0871161', 'cui_str': 'Property (attribute)'}, {'cui': 'C1140999', 'cui_str': 'Contraction (finding)'}, {'cui': 'C1632851', 'cui_str': 'Times'}]",23.0,0.0362876,"The main effect of time (for take-off velocity p=.023; ɳ 2 = .236) and group x time interactions (for CMJ, Tc (BF, GM), Dm (BF) and EME p<.05;","[{'ForeName': 'Damir', 'Initials': 'D', 'LastName': 'Zubac', 'Affiliation': 'University of Split, Faculty of Kinesiology, Croatia.'}, {'ForeName': 'Armin', 'Initials': 'A', 'LastName': 'Paravlić', 'Affiliation': ''}, {'ForeName': 'Katja', 'Initials': 'K', 'LastName': 'Koren', 'Affiliation': ''}, {'ForeName': 'Urzi', 'Initials': 'U', 'LastName': 'Felicita', 'Affiliation': ''}, {'ForeName': 'Boštjan', 'Initials': 'B', 'LastName': 'Šimunič', 'Affiliation': ''}]",Journal of musculoskeletal & neuronal interactions,[] 3315,31399381,"Personalised mechanical ventilation tailored to lung morphology versus low positive end-expiratory pressure for patients with acute respiratory distress syndrome in France (the LIVE study): a multicentre, single-blind, randomised controlled trial.","BACKGROUND The effect of personalised mechanical ventilation on clinical outcomes in patients with acute respiratory distress syndrome (ARDS) remains uncertain and needs to be evaluated. We aimed to test whether a mechanical ventilation strategy that was personalised to individual patients' lung morphology would improve the survival of patients with ARDS when compared with standard of care. METHODS We designed a multicentre, single-blind, stratified, parallel-group, randomised controlled trial enrolling patients with moderate-to-severe ARDS in 20 university or non-university intensive care units in France. Patients older than 18 years with early ARDS for less than 12 h were randomly assigned (1:1) to either the control group or the personalised group using a minimisation algorithm and stratified according to the study site, lung morphology, and duration of mechanical ventilation. Only the patients were masked to allocation. In the control group, patients received a tidal volume of 6 mL/kg per predicted bodyweight and positive end-expiratory pressure (PEEP) was selected according to a low PEEP and fraction of inspired oxygen table, and early prone position was encouraged. In the personalised group, the treatment approach was based on lung morphology; patients with focal ARDS received a tidal volume of 8 mL/kg, low PEEP, and prone position. Patients with non-focal ARDS received a tidal volume of 6 mL/kg, along with recruitment manoeuvres and high PEEP. The primary outcome was 90-day mortality as established by intention-to-treat analysis. This study is registered online with ClinicalTrials.gov, NCT02149589. FINDINGS From June 12, 2014, to Feb 2, 2017, 420 patients were randomly assigned to treatment. 11 patients were excluded in the personalised group and nine patients were excluded in the control group; 196 patients in the personalised group and 204 in the control group were included in the analysis. In a multivariate analysis, there was no difference in 90-day mortality between the group treated with personalised ventilation and the control group in the intention-to-treat analysis (hazard ratio [HR] 1·01; 95% CI 0·61-1·66; p=0·98). However, misclassification of patients as having focal or non-focal ARDS by the investigators was observed in 85 (21%) of 400 patients. We found a significant interaction between misclassification and randomised group allocation with respect to the primary outcome (p<0·001). In the subgroup analysis, the 90-day mortality of the misclassified patients was higher in the personalised group (26 [65%] of 40 patients) than in the control group (18 [32%] of 57 patients; HR 2·8; 95% CI 1·5-5·1; p=0·012. INTERPRETATION Personalisation of mechanical ventilation did not decrease mortality in patients with ARDS, possibly because of the misclassification of 21% of patients. A ventilator strategy misaligned with lung morphology substantially increases mortality. Whether improvement in ARDS phenotyping can decrease mortality should be assessed in a future clinical trial. FUNDING French Ministry of Health (Programme Hospitalier de Recherche Clinique InterRégional 2013).",2019,"In a multivariate analysis, there was no difference in 90-day mortality between the group treated with personalised ventilation and the control group in the intention-to-treat analysis (hazard ratio [HR] 1·01; 95% CI 0·61-1·66; p=0·98).","['Patients older than 18 years with early ARDS for less than 12 h', 'patients with moderate-to-severe ARDS in 20 university or non-university intensive care units in France', 'patients with acute respiratory distress syndrome (ARDS', '11 patients were excluded in the personalised group and nine patients were excluded in the control group; 196 patients in the personalised group and 204 in the control group were included in the analysis', 'patients with ARDS', 'From June 12, 2014, to Feb 2, 2017, 420 patients', 'Patients with non-focal ARDS', 'patients with acute respiratory distress syndrome in France (the LIVE study']","['personalised mechanical ventilation', 'mechanical ventilation strategy', 'Personalised mechanical ventilation tailored to lung morphology versus low positive end-expiratory pressure', 'control group or the personalised group using a minimisation algorithm', 'tidal volume of 6 mL/kg per predicted bodyweight and positive end-expiratory pressure (PEEP']","['mortality', '90-day mortality', '90-day mortality as established by intention-to-treat analysis']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0035222', 'cui_str': 'ARDS, Human'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0021708', 'cui_str': 'Intensive care unit (environment)'}, {'cui': 'C0016674', 'cui_str': 'France'}, {'cui': 'C0332196', 'cui_str': 'Exclude (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C4517625', 'cui_str': '196'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C4517774', 'cui_str': 'Four hundred and twenty'}, {'cui': 'C0205234', 'cui_str': 'Focal (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}]","[{'cui': 'C0199470', 'cui_str': 'Mechanically assisted ventilation'}, {'cui': 'C0024109', 'cui_str': 'Lung'}, {'cui': 'C0543482', 'cui_str': 'morphology'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C3494516', 'cui_str': 'Positive end expiratory pressure (observable entity)'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}, {'cui': 'C0002045'}, {'cui': 'C0040210', 'cui_str': 'Tidal Volume'}, {'cui': 'C1300574', 'cui_str': 'microliter/g'}, {'cui': 'C0863179', 'cui_str': 'Peeping'}]","[{'cui': 'C0026566', 'cui_str': 'mortality'}, {'cui': 'C0439228', 'cui_str': 'day (qualifier value)'}, {'cui': 'C0443211', 'cui_str': 'Established (qualifier value)'}, {'cui': 'C2718028', 'cui_str': 'Intention to Treat Analysis'}]",420.0,0.351297,"In a multivariate analysis, there was no difference in 90-day mortality between the group treated with personalised ventilation and the control group in the intention-to-treat analysis (hazard ratio [HR] 1·01; 95% CI 0·61-1·66; p=0·98).","[{'ForeName': 'Jean-Michel', 'Initials': 'JM', 'LastName': 'Constantin', 'Affiliation': 'Department of Perioperative Medicine, University Hospital of Clermont-Ferrand, Clermont-Ferrand, France; Laboratoire Génétique, Reproduction, et Développement, Centre National de la Recherche Scientifique (CNRS), Institut National de la Santé et de la Recherche Médicale (INSERM), Université Clermont Auvergne, Clermont-Ferrand, France; Multidisciplinary Intensive Care Unit, Department of Anaesthesiology and Critical Care, Pitié-Salpêtrière Hospital, Assistance Publique Hôpitaux de Paris, Paris, France. Electronic address: jmconstantin@chu-clermontferrand.fr.'}, {'ForeName': 'Matthieu', 'Initials': 'M', 'LastName': 'Jabaudon', 'Affiliation': 'Department of Perioperative Medicine, University Hospital of Clermont-Ferrand, Clermont-Ferrand, France; Laboratoire Génétique, Reproduction, et Développement, Centre National de la Recherche Scientifique (CNRS), Institut National de la Santé et de la Recherche Médicale (INSERM), Université Clermont Auvergne, Clermont-Ferrand, France.'}, {'ForeName': 'Jean-Yves', 'Initials': 'JY', 'LastName': 'Lefrant', 'Affiliation': 'Service des Réanimations, Pôle Anesthésie Douleur Urgences Réanimation, Centre Hospitalier Universitaire de Nîmes, Nîmes, France.'}, {'ForeName': 'Samir', 'Initials': 'S', 'LastName': 'Jaber', 'Affiliation': 'Montpellier University Hospital, Saint Eloi Intensive Care Unit and PhyMedExp, University of Montpellier, INSERM, CNRS, Montpellier, France.'}, {'ForeName': 'Jean-Pierre', 'Initials': 'JP', 'LastName': 'Quenot', 'Affiliation': ""Department of Intensive Care, François Mitterrand University Hospital, Dijon, France; Lipness Team, INSERM Research Centre, and LabExLipSTIC, University of Burgundy, Dijon, France; INSERM Centres d'Investigation Clinique, Department of Clinical Epidemiology, University of Burgundy, Dijon, France.""}, {'ForeName': 'Olivier', 'Initials': 'O', 'LastName': 'Langeron', 'Affiliation': 'Multidisciplinary Intensive Care Unit, Department of Anaesthesiology and Critical Care, Pitié-Salpêtrière Hospital, Assistance Publique Hôpitaux de Paris, Paris, France.'}, {'ForeName': 'Martine', 'Initials': 'M', 'LastName': 'Ferrandière', 'Affiliation': 'Department of Anaesthesia and Intensive Care Medicine, Regional University Centre of Tours, Tours, France.'}, {'ForeName': 'Fabien', 'Initials': 'F', 'LastName': 'Grelon', 'Affiliation': 'Service de Réanimation, General Hospital Le Mans, Le Mans, France.'}, {'ForeName': 'Philippe', 'Initials': 'P', 'LastName': 'Seguin', 'Affiliation': 'Department of Intensive Care Medicine, University Hospital of Rennes, University of Rennes 1 and Unité Mixte de Recherche NuMeCan, Rennes, France.'}, {'ForeName': 'Carole', 'Initials': 'C', 'LastName': 'Ichai', 'Affiliation': ""Intensive Care Unit, University Hospital of Nice, Université Côte d'Azur, Nice, France.""}, {'ForeName': 'Benoit', 'Initials': 'B', 'LastName': 'Veber', 'Affiliation': 'Pôle Anesthésie-Réanimation-SAMU, Rouen University Hospital, Rouen, France.'}, {'ForeName': 'Bertrand', 'Initials': 'B', 'LastName': 'Souweine', 'Affiliation': 'Service de Médicine Intensive et Réanimation, University Hospital of Clermont-Ferrand, Clermont-Ferrand, France.'}, {'ForeName': 'Thomas', 'Initials': 'T', 'LastName': 'Uberti', 'Affiliation': 'Department of Anaesthesiology and Intensive Care Medicine, Edouard Herriot Hospital, Hospices Civils de Lyon, Lyon, France.'}, {'ForeName': 'Sigismond', 'Initials': 'S', 'LastName': 'Lasocki', 'Affiliation': 'Department of Anaesthesiology and Reanimation, University Hospital Angers, Angers, France.'}, {'ForeName': 'François', 'Initials': 'F', 'LastName': 'Legay', 'Affiliation': 'Service de Réanimation, Hospital General Saint-Brieuc, Saint-Brieuc, France.'}, {'ForeName': 'Marc', 'Initials': 'M', 'LastName': 'Leone', 'Affiliation': ""Service d'Anesthésie-Réanimation, Assistance Publique-Hôpitaux de Marseille, Hôpital Nord, Aix-Marseille Université, Marseille, France.""}, {'ForeName': 'Nathanael', 'Initials': 'N', 'LastName': 'Eisenmann', 'Affiliation': 'Department of Anaesthesiology and Critical Care, Centre Régional de Lutte Contre le Cancer Jean Perrin, Clermont-Ferrand, France.'}, {'ForeName': 'Claire', 'Initials': 'C', 'LastName': 'Dahyot-Fizelier', 'Affiliation': 'Department of Anaesthesia-Intensive Care and Perioperative Medicine, University Hospital of Poitiers, University of Poitiers, INSERM, Poitiers, France.'}, {'ForeName': 'Hervé', 'Initials': 'H', 'LastName': 'Dupont', 'Affiliation': ""Unité de Recherche Clinique Simplification des Soins chez les Patients Complexes, Université Jules Verne de Picardie, Service d'Anesthésie-Réanimation, Centre Hospitalier Universitaire d'Amiens Picardie, Amiens, France.""}, {'ForeName': 'Karim', 'Initials': 'K', 'LastName': 'Asehnoune', 'Affiliation': ""Service d'Anesthésie Réanimation Chirurgicale, Centre Hospitalier Universitaire de Nantes, Hôtel Dieu-HME Hospital, Nantes, France.""}, {'ForeName': 'Achille', 'Initials': 'A', 'LastName': 'Sossou', 'Affiliation': 'Service de Réanimation, Centre Hospitalier Général du Puy-en-Velay, Puy-en-Velay, France.'}, {'ForeName': 'Gérald', 'Initials': 'G', 'LastName': 'Chanques', 'Affiliation': 'Montpellier University Hospital, Saint Eloi Intensive Care Unit and PhyMedExp, University of Montpellier, INSERM, CNRS, Montpellier, France.'}, {'ForeName': 'Laurent', 'Initials': 'L', 'LastName': 'Muller', 'Affiliation': 'Service des Réanimations, Pôle Anesthésie Douleur Urgences Réanimation, Centre Hospitalier Universitaire de Nîmes, Nîmes, France.'}, {'ForeName': 'Jean-Etienne', 'Initials': 'JE', 'LastName': 'Bazin', 'Affiliation': 'Department of Perioperative Medicine, University Hospital of Clermont-Ferrand, Clermont-Ferrand, France; Laboratoire Génétique, Reproduction, et Développement, Centre National de la Recherche Scientifique (CNRS), Institut National de la Santé et de la Recherche Médicale (INSERM), Université Clermont Auvergne, Clermont-Ferrand, France.'}, {'ForeName': 'Antoine', 'Initials': 'A', 'LastName': 'Monsel', 'Affiliation': 'Multidisciplinary Intensive Care Unit, Department of Anaesthesiology and Critical Care, Pitié-Salpêtrière Hospital, Assistance Publique Hôpitaux de Paris, Paris, France.'}, {'ForeName': 'Lucile', 'Initials': 'L', 'LastName': 'Borao', 'Affiliation': 'Biostatistical Unit, Department of Clinical Research and Innovation, University Hospital of Clermont-Ferrand, Clermont-Ferrand, France.'}, {'ForeName': 'Jean-Marc', 'Initials': 'JM', 'LastName': 'Garcier', 'Affiliation': 'Department of Radiology, Estaing Hospital, University Hospital of Clermont-Ferrand, Clermont-Ferrand, France.'}, {'ForeName': 'Jean-Jacques', 'Initials': 'JJ', 'LastName': 'Rouby', 'Affiliation': 'Multidisciplinary Intensive Care Unit, Department of Anaesthesiology and Critical Care, Pitié-Salpêtrière Hospital, Assistance Publique Hôpitaux de Paris, Paris, France.'}, {'ForeName': 'Bruno', 'Initials': 'B', 'LastName': 'Pereira', 'Affiliation': 'Biostatistical Unit, Department of Clinical Research and Innovation, University Hospital of Clermont-Ferrand, Clermont-Ferrand, France.'}, {'ForeName': 'Emmanuel', 'Initials': 'E', 'LastName': 'Futier', 'Affiliation': 'Department of Perioperative Medicine, University Hospital of Clermont-Ferrand, Clermont-Ferrand, France; Laboratoire Génétique, Reproduction, et Développement, Centre National de la Recherche Scientifique (CNRS), Institut National de la Santé et de la Recherche Médicale (INSERM), Université Clermont Auvergne, Clermont-Ferrand, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",The Lancet. Respiratory medicine,['10.1016/S2213-2600(19)30138-9'] 3316,31553946,Effectiveness of the 5A's Model for Changing Physical Activity Behaviors in Rural Adults Recruited From Primary Care Clinics.,"BACKGROUND Most rural adults do not meet current guidelines for physical activity (PA). A 12-week feasibility study tested the effectiveness of using the 5A's model for PA counseling on rural adults' PA behaviors. METHODS Inactive rural adults recruited from a primary care clinic were randomized to an intervention (n = 30) or control (n = 29) group. All subjects wore a Fitbit to track steps and active minutes. The intervention group completed action plans to improve self-regulatory PA strategies and received weekly motivational text messages to improve PA behaviors. Theory of planned behavior constructs and self-regulatory strategies of planning, goal setting, and tracking (steps and active minutes) were measured with both groups. The control group received the Fitbit only. RESULTS All individuals became more physically active; however, no significant differences between groups in active minutes or steps were found. All subjects, regardless of group, increased steps (P > .05). There were no statistically significant differences between groups on any of the theoretical variables. CONCLUSIONS It is vitally important to continue to find ways to make PA a priority to improve the overall health and well-being of rural adults. Future research warrants adjusting the intervention dose and strategies to increase PA that can be maintained long term.",2019,"All subjects, regardless of group, increased steps (P > .05).","[""rural adults' PA behaviors"", 'Inactive rural adults recruited from a primary care clinic', 'Rural Adults Recruited From Primary Care Clinics', 'rural adults']","[""5A's model for PA counseling"", 'action plans to improve self-regulatory PA strategies and received weekly motivational text messages', ""5A's Model""]",[],"[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0004927', 'cui_str': 'Behavior'}, {'cui': 'C0205254', 'cui_str': 'Inactive (qualifier value)'}, {'cui': 'C1552443', 'cui_str': 'Primary care clinic (environment)'}]","[{'cui': 'C0026350', 'cui_str': 'Models, Theoretic'}, {'cui': 'C0010210', 'cui_str': 'Counseling'}, {'cui': 'C1273866', 'cui_str': 'Action plan (community)'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0036588', 'cui_str': 'Self'}, {'cui': 'C0332174', 'cui_str': 'Weekly (qualifier value)'}, {'cui': 'C3178910', 'cui_str': 'Text Messages'}]",[],,0.0202682,"All subjects, regardless of group, increased steps (P > .05).","[{'ForeName': 'Jill R', 'Initials': 'JR', 'LastName': 'Reed', 'Affiliation': ''}, {'ForeName': 'Paul', 'Initials': 'P', 'LastName': 'Estabrooks', 'Affiliation': ''}, {'ForeName': 'Bunny', 'Initials': 'B', 'LastName': 'Pozehl', 'Affiliation': ''}, {'ForeName': 'Kate', 'Initials': 'K', 'LastName': 'Heelan', 'Affiliation': ''}, {'ForeName': 'Christopher', 'Initials': 'C', 'LastName': 'Wichman', 'Affiliation': ''}]",Journal of physical activity & health,['10.1123/jpah.2018-0477'] 3317,30476361,"Abuse Potential of Samidorphan: A Phase I, Oxycodone-, Pentazocine-, Naltrexone-, and Placebo-Controlled Study.","Samidorphan is a μ-opioid receptor antagonist in development for the treatment of schizophrenia, in combination with olanzapine, and major depressive disorder, in combination with buprenorphine, at proposed therapeutic doses of samidorphan 10 mg and 2 mg, respectively. A double-blind, double-dummy, active- and placebo-controlled, crossover study evaluated the abuse potential of samidorphan in healthy, nondependent, recreational opioid users. Following a qualification phase, participants were randomized to 1 of 6 treatment sequences of study drugs: placebo, samidorphan (10 or 30 mg), oxycodone (40 mg), pentazocine (30 mg), and naltrexone (100 mg) in a 6 × 6 Williams design. The primary end point was maximum effect (E max ) for ""at-the-moment"" Drug Liking visual analog scale scores. Secondary end points included E max visual analog scale scores for Take Drug Again and Overall Drug Liking and safety assessments. Among 47 participants, at-the-moment E max Drug Liking scores for positive study controls oxycodone and pentazocine were significantly higher than placebo (P < .001) and samidorphan (both doses; P < .001). Both samidorphan doses had E max Drug Liking scores similar to placebo and naltrexone (median within-subject differences of 0.0). E max Take Drug Again scores for samidorphan (both doses) were higher than placebo, but similar to naltrexone, an unscheduled μ-opioid receptor antagonist. Adverse events to evaluate abuse potential occurred less frequently with samidorphan, naltrexone, and placebo than with oxycodone and pentazocine. Findings from this study support a lack of abuse potential with samidorphan at doses up to 30 mg and a safety profile consistent with previous samidorphan clinical studies.",2019,"Adverse events to evaluate abuse potential occurred less frequently with samidorphan, naltrexone, and placebo than with oxycodone and pentazocine.","['healthy, nondependent, recreational opioid users']","['Samidorphan', 'oxycodone', 'placebo', 'samidorphan, naltrexone', 'naltrexone', 'buprenorphine', 'samidorphan', 'pentazocine', 'placebo and naltrexone', 'olanzapine', 'Oxycodone-, Pentazocine-, Naltrexone-, and Placebo', 'double-dummy, active- and placebo', 'placebo, samidorphan']","['E max visual analog scale scores for Take Drug Again and Overall Drug Liking and safety assessments', 'maximum effect (E max ) for ""at-the-moment"" Drug Liking visual analog scale scores', 'moment E max Drug Liking scores', 'E max Take Drug Again scores', 'E max Drug Liking scores']","[{'cui': 'C0242402', 'cui_str': 'Opioids'}]","[{'cui': 'C4277369', 'cui_str': '3-carboxamido-4-hydroxynaltrexone'}, {'cui': 'C0030049', 'cui_str': 'Oxycodone'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0027360', 'cui_str': 'Naltrexone'}, {'cui': 'C0006405', 'cui_str': 'Buprenorphine'}, {'cui': 'C0030873', 'cui_str': 'Pentazocine'}, {'cui': 'C0171023', 'cui_str': 'olanzapine'}, {'cui': 'C0205173', 'cui_str': 'Double (qualifier value)'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}]","[{'cui': 'C0806909', 'cui_str': 'Max'}, {'cui': 'C2960751', 'cui_str': 'Visual analog scale score'}, {'cui': 'C0013227', 'cui_str': 'Pharmaceuticals'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C1261322', 'cui_str': 'Clinical evaluation'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}]",,0.167081,"Adverse events to evaluate abuse potential occurred less frequently with samidorphan, naltrexone, and placebo than with oxycodone and pentazocine.","[{'ForeName': 'Sanjeev', 'Initials': 'S', 'LastName': 'Pathak', 'Affiliation': 'Alkermes, Inc., Waltham, MA, USA.'}, {'ForeName': 'Bradley', 'Initials': 'B', 'LastName': 'Vince', 'Affiliation': 'Vince & Associates Clinical Research, Altasciences, Overland Park, KS, USA.'}, {'ForeName': 'Debra', 'Initials': 'D', 'LastName': 'Kelsh', 'Affiliation': 'Vince & Associates Clinical Research, Altasciences, Overland Park, KS, USA.'}, {'ForeName': 'Beatrice', 'Initials': 'B', 'LastName': 'Setnik', 'Affiliation': 'Syneos Health, Raleigh, NC, USA.'}, {'ForeName': 'Narinder', 'Initials': 'N', 'LastName': 'Nangia', 'Affiliation': 'Alkermes, Inc., Waltham, MA, USA.'}, {'ForeName': 'Lauren', 'Initials': 'L', 'LastName': 'DiPetrillo', 'Affiliation': 'Alkermes, Inc., Waltham, MA, USA.'}, {'ForeName': 'Matthew D', 'Initials': 'MD', 'LastName': 'Puhl', 'Affiliation': 'Alkermes, Inc., Waltham, MA, USA.'}, {'ForeName': 'Lei', 'Initials': 'L', 'LastName': 'Sun', 'Affiliation': 'Alkermes, Inc., Waltham, MA, USA.'}, {'ForeName': 'Arielle D', 'Initials': 'AD', 'LastName': 'Stanford', 'Affiliation': 'Alkermes, Inc., Waltham, MA, USA.'}, {'ForeName': 'Elliot', 'Initials': 'E', 'LastName': 'Ehrich', 'Affiliation': 'Alkermes, Inc., Waltham, MA, USA.'}]",Journal of clinical pharmacology,['10.1002/jcph.1343'] 3318,31553815,Internet-assisted cognitive behavioral intervention for targeted therapy-related fatigue in chronic myeloid leukemia: Results from a pilot randomized trial.,"BACKGROUND Fatigue is a common and disabling side effect of targeted therapies such as tyrosine kinase inhibitors (TKIs) used to treat chronic myeloid leukemia (CML). The goal of the current study was to conduct a pilot randomized trial of the first cognitive behavioral intervention developed for fatigue due to targeted therapy. METHODS Patients with CML treated with a TKI who were reporting moderate to severe fatigue were recruited and randomized 2:1 to cognitive behavioral therapy for targeted therapy-related fatigue (CBT-TTF) delivered via FaceTime for the iPad or to a waitlist control (WLC) group. The outcomes were acceptability, feasibility, and preliminary efficacy for fatigue (Functional Assessment of Chronic Illness Therapy-Fatigue; primary outcome) and quality of life (Functional Assessment of Cancer Therapy-General; secondary outcome). Participants were assessed before randomization and after treatment (ie, approximately 18 weeks later). RESULTS A total of 44 patients (mean age, 55 years; 48% female) were assigned to CBT-TTF (n = 29) or WLC (n = 15). The study participation rate was 59%. Among the patients assigned to CBT-TTF, 79% completed the intervention. Intent-to-treat analyses indicated that patients assigned to CBT-TTF demonstrated greater improvements in fatigue (d = 1.06; P < .001) and overall quality of life (d = 1.15; P = .005) than those assigned to WLC. More patients randomized to CBT-TTF than WLC demonstrated clinically significant improvements in fatigue (85% vs 29%) and quality of life (88% vs 54%; P values ≤ .016). CONCLUSIONS CBT-TTF displays preliminary efficacy in improving fatigue and quality of life among fatigued patients with CML treated with TKIs. The findings suggest that a larger randomized study is warranted.",2020,"More patients randomized to CBT-TTF than WLC demonstrated clinically significant improvements in fatigue (85% vs 29%) and quality of life (88% vs 54%; P values ≤ .016). ","['fatigued patients with CML treated with TKIs', 'Patients with CML treated with a TKI who were reporting moderate to severe fatigue', 'chronic myeloid leukemia', '44 patients (mean age, 55\xa0years; 48% female']","['Internet-assisted cognitive behavioral intervention', 'cognitive behavioral intervention', 'WLC', 'cognitive behavioral therapy for targeted therapy-related fatigue (CBT-TTF) delivered via FaceTime for the iPad or to a waitlist control (WLC', 'CBT-TTF']","['acceptability, feasibility, and preliminary efficacy for fatigue (Functional Assessment of Chronic Illness Therapy-Fatigue; primary outcome) and quality of life (Functional Assessment of Cancer Therapy-General; secondary outcome', 'quality of life', 'fatigue and quality of life', 'overall quality of life', 'fatigue']","[{'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0023473', 'cui_str': 'Leukemia, Granulocytic, Chronic'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0684224', 'cui_str': 'Report'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086287', 'cui_str': 'Females'}]","[{'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C1269765', 'cui_str': 'Assists (attribute)'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0439611', 'cui_str': 'Preliminary (qualifier value)'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C0278372', 'cui_str': 'Functional assessment'}, {'cui': 'C0008679', 'cui_str': 'Chronic Illness'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0439631', 'cui_str': 'Primary operation (qualifier value)'}, {'cui': 'C0034380'}, {'cui': 'C1306459', 'cui_str': 'Primary malignant neoplasm'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0282416', 'cui_str': 'Overall'}]",,0.136093,"More patients randomized to CBT-TTF than WLC demonstrated clinically significant improvements in fatigue (85% vs 29%) and quality of life (88% vs 54%; P values ≤ .016). ","[{'ForeName': 'Heather S L', 'Initials': 'HSL', 'LastName': 'Jim', 'Affiliation': 'Department of Health Outcomes and Behavior, Moffitt Cancer Center, Tampa, Florida.'}, {'ForeName': 'Kelly A', 'Initials': 'KA', 'LastName': 'Hyland', 'Affiliation': 'Department of Psychology, University of South Florida, Tampa, Florida.'}, {'ForeName': 'Ashley M', 'Initials': 'AM', 'LastName': 'Nelson', 'Affiliation': 'Department of Psychology, University of South Florida, Tampa, Florida.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Pinilla-Ibarz', 'Affiliation': 'Department of Malignant Hematology, Moffitt Cancer Center, Tampa, Florida.'}, {'ForeName': 'Kendra', 'Initials': 'K', 'LastName': 'Sweet', 'Affiliation': 'Department of Malignant Hematology, Moffitt Cancer Center, Tampa, Florida.'}, {'ForeName': 'Marieke', 'Initials': 'M', 'LastName': 'Gielissen', 'Affiliation': 'Department of Medical Psychology, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Hailey', 'Initials': 'H', 'LastName': 'Bulls', 'Affiliation': 'Department of Health Outcomes and Behavior, Moffitt Cancer Center, Tampa, Florida.'}, {'ForeName': 'Aasha I', 'Initials': 'AI', 'LastName': 'Hoogland', 'Affiliation': 'Department of Health Outcomes and Behavior, Moffitt Cancer Center, Tampa, Florida.'}, {'ForeName': 'Paul B', 'Initials': 'PB', 'LastName': 'Jacobsen', 'Affiliation': 'Healthcare Delivery Research Program, National Cancer Institute, Bethesda, Maryland.'}, {'ForeName': 'Hans', 'Initials': 'H', 'LastName': 'Knoop', 'Affiliation': 'Department of Medical Psychology, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam, the Netherlands.'}]",Cancer,['10.1002/cncr.32521'] 3319,30876859,Environmental enrichment and amantadine confer individual but nonadditive enhancements in motor and spatial learning after controlled cortical impact injury.,"Environmental enrichment (EE) and amantadine (AMT) enhance motor and cognitive outcome after experimental traumatic brain injury (TBI). However, there are no data on the effects of combining these two therapies. Hence, the aim of the current study was to combine EE and AMT after TBI to determine if their net effect further enhances motor and cognitive performance. Anesthetized adult male rats received either a cortical impact of moderate severity or sham injury and then were randomly assigned to EE or standard (STD) housing and once daily administration of AMT (20 mg/kg; i.p.) or saline vehicle (VEH, 1 mL/kg; i.p.) beginning 24 h after injury for 19 days. Motor and cognitive function were assessed on post-surgical days 1-5 and 14-19, respectively. Cortical lesion volume was quantified on day 21. There were no statistical differences among the sham groups regardless of therapy, so the data were pooled. EE, AMT, and their combination (EE + AMT) improved beam-balance, but only EE and EE + AMT enhanced beam-walking. All three treatment paradigms improved spatial learning and memory relative to the VEH-treated STD controls (p < 0.05). No differences were revealed between the EE groups, regardless of treatment, but both were better than the AMT-treated STD group on beam-walking and spatial learning (p < 0.05). Both EE groups equally reduced cortical lesion volume relative to the STD-housed AMT and VEH groups (p < 0.05). The results indicate that although beneficial on their own, EE + AMT do not provide additional benefits after TBI. It is important to note that the lack of additive effects using the current treatment and behavioral protocols does not detract from the benefits of each individual therapy. The findings provide insight for future combination studies.",2019,"No differences were revealed between the EE groups, regardless of treatment, but both were better than the AMT-treated STD group on beam-walking and spatial learning (p < 0.05).","['Anesthetized adult male rats', 'experimental traumatic brain injury (TBI']","['cortical impact of moderate severity or sham injury and then were randomly assigned to EE or standard (STD) housing and once daily administration of AMT', 'amantadine', 'saline vehicle (VEH', 'Environmental enrichment (EE) and amantadine (AMT']","['Motor and cognitive function', 'Cortical lesion volume', 'spatial learning and memory relative', 'cortical lesion volume']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0034721', 'cui_str': 'Rats'}, {'cui': 'C0876926', 'cui_str': 'TBI (Traumatic Brain Injury)'}]","[{'cui': 'C0333125', 'cui_str': 'Impacted (qualifier value)'}, {'cui': 'C0205081', 'cui_str': 'Moderate (severity modifier) (qualifier value)'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}, {'cui': 'C0073980', 'cui_str': 'SHAM'}, {'cui': 'C3263722', 'cui_str': 'Traumatic AND/OR non-traumatic injury'}, {'cui': 'C1516050', 'cui_str': 'Assigned (qualifier value)'}, {'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0020056', 'cui_str': 'Housing'}, {'cui': 'C0556983', 'cui_str': 'Once daily (qualifier value)'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0002403', 'cui_str': 'Amantadine'}, {'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0042444', 'cui_str': 'Drug vehicle (substance)'}]","[{'cui': 'C0392335', 'cui_str': 'Cognitive functions (observable entity)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0582587', 'cui_str': 'Spatial Learning'}, {'cui': 'C0025260', 'cui_str': 'Memory'}, {'cui': 'C0205345', 'cui_str': 'Relative (qualifier value)'}]",,0.0451861,"No differences were revealed between the EE groups, regardless of treatment, but both were better than the AMT-treated STD group on beam-walking and spatial learning (p < 0.05).","[{'ForeName': 'Isabel H', 'Initials': 'IH', 'LastName': 'Bleimeister', 'Affiliation': 'Physical Medicine & Rehabilitation, University of Pittsburgh, Pittsburgh, PA 15213, United States; Safar Center for Resuscitation Research, University of Pittsburgh, Pittsburgh, PA 15213, United States.'}, {'ForeName': 'Mia', 'Initials': 'M', 'LastName': 'Wolff', 'Affiliation': 'Physical Medicine & Rehabilitation, University of Pittsburgh, Pittsburgh, PA 15213, United States; Safar Center for Resuscitation Research, University of Pittsburgh, Pittsburgh, PA 15213, United States.'}, {'ForeName': 'Tracey R', 'Initials': 'TR', 'LastName': 'Lam', 'Affiliation': 'Physical Medicine & Rehabilitation, University of Pittsburgh, Pittsburgh, PA 15213, United States; Safar Center for Resuscitation Research, University of Pittsburgh, Pittsburgh, PA 15213, United States.'}, {'ForeName': 'Derrick M', 'Initials': 'DM', 'LastName': 'Brooks', 'Affiliation': 'Physical Medicine & Rehabilitation, University of Pittsburgh, Pittsburgh, PA 15213, United States; Safar Center for Resuscitation Research, University of Pittsburgh, Pittsburgh, PA 15213, United States.'}, {'ForeName': 'Reece', 'Initials': 'R', 'LastName': 'Patel', 'Affiliation': 'Physical Medicine & Rehabilitation, University of Pittsburgh, Pittsburgh, PA 15213, United States; Safar Center for Resuscitation Research, University of Pittsburgh, Pittsburgh, PA 15213, United States.'}, {'ForeName': 'Jeffrey P', 'Initials': 'JP', 'LastName': 'Cheng', 'Affiliation': 'Physical Medicine & Rehabilitation, University of Pittsburgh, Pittsburgh, PA 15213, United States; Safar Center for Resuscitation Research, University of Pittsburgh, Pittsburgh, PA 15213, United States.'}, {'ForeName': 'Corina O', 'Initials': 'CO', 'LastName': 'Bondi', 'Affiliation': 'Physical Medicine & Rehabilitation, University of Pittsburgh, Pittsburgh, PA 15213, United States; Safar Center for Resuscitation Research, University of Pittsburgh, Pittsburgh, PA 15213, United States; Neurobiology, University of Pittsburgh, Pittsburgh, PA 15213, United States; Center for Neuroscience, University of Pittsburgh, Pittsburgh, PA 15213, United States.'}, {'ForeName': 'Anthony E', 'Initials': 'AE', 'LastName': 'Kline', 'Affiliation': 'Physical Medicine & Rehabilitation, University of Pittsburgh, Pittsburgh, PA 15213, United States; Safar Center for Resuscitation Research, University of Pittsburgh, Pittsburgh, PA 15213, United States; Center for Neuroscience, University of Pittsburgh, Pittsburgh, PA 15213, United States; Center for the Neural Basis of Cognition, University of Pittsburgh, Pittsburgh, PA 15213, United States; Critical Care Medicine, University of Pittsburgh, Pittsburgh, PA 15213, United States; University of Pittsburgh, Pittsburgh, PA 15213, United States. Electronic address: klineae@upmc.edu.'}]",Brain research,['10.1016/j.brainres.2019.03.007'] 3320,31483155,Impact of acute antioxidant administration on inflammation and vascular function in heart failure with preserved ejection fraction.,"Although it is now well established that heart failure with preserved ejection fraction (HFpEF) is associated with marked inflammation and a prooxidant state that is accompanied by vascular dysfunction, whether acute antioxidant (AO) administration can effectively target these disease-related decrements has not been evaluated. Thus, the present study sought to evaluate the efficacy of an acute over-the-counter AO cocktail (600 mg α-lipoic acid, 1,000 mg vitamin C, and 600 IU vitamin E) to mitigate inflammation and oxidative stress, and subsequently improve nitric oxide (NO) bioavailability and vascular function, in patients with HFpEF. Flow-mediated dilation (FMD) and reactive hyperemia (RH) were evaluated to assess conduit vessel and microvascular function, respectively, 90 min after administration of either placebo (PL) or AO in 16 patients with HFpEF (73 ± 10 yr, EF 54-70%) using a double-blind, crossover design. Circulating biomarkers of inflammation (C-reactive protein, CRP), oxidative stress (malondialdehyde and protein carbonyl), free radical concentration (EPR spectroscopy), antioxidant capacity, ascorbate and NO bioavailability (plasma nitrate, [Formula: see text], and nitrite, [Formula: see text]) were also assessed. FMD improved following AO administration (PL: 3.49 ± 0.7%, AO: 5.83 ± 1.0%), whereas RH responses were similar between conditions (PL: 428 ± 51 mL, AO: 425 ± 51 mL). AO administration decreased CRP (PL: 4,429 ± 705 ng/mL, AO: 3,664 ± 520 ng/mL) and increased ascorbate (PL: 30.0 ± 2.9 µg/mL, AO: 45.1 ± 3.7 µg/mL) and [Formula: see text] (PL: 182 ± 21 nM, AO: 213 ± 24 nM) but did not affect other biomarkers. Together, these data suggest that acute AO administration can exert anti-inflammatory effects and improve conduit artery vasodilation, but not microvascular function, in patients with HFpEF.",2019,"Circulating biomarkers of inflammation (C-reactive protein, CRP), oxidative stress (Malondialdehyde and Protein Carbonyl), free radical concentration (EPR Spectroscopy), antioxidant capacity, ascorbate and NO bioavailability (plasma nitrate, NO 3 - , and nitrite, NO 2 - ) were also assessed. ","['Heart Failure with Preserved Ejection Fraction', '16 patients with HFpEF', 'patients with HFpEF']","['Acute Antioxidant Administration', 'counter AO cocktail (600mg alpha lipoic acid, 1,000mg Vitamin C, and 600IU vitamin E', 'placebo (PL']","['RH responses', 'nitric oxide (NO) bioavailability and vascular function', 'Inflammation and Vascular Function', 'Flow mediated dilation (FMD) and reactive hyperemia (RH', 'Circulating biomarkers of inflammation (C-reactive protein, CRP), oxidative stress (Malondialdehyde and Protein Carbonyl), free radical concentration (EPR Spectroscopy), antioxidant capacity, ascorbate and NO bioavailability (plasma nitrate, NO 3 - , and nitrite, NO 2 - ', 'FMD', 'conduit artery vasodilation']","[{'cui': 'C0018801', 'cui_str': 'Cardiac Failure'}, {'cui': 'C0728887', 'cui_str': 'Preserving (attribute)'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C1533734', 'cui_str': 'Administration'}, {'cui': 'C0677601', 'cui_str': 'Counter (physical object)'}, {'cui': 'C0678420', 'cui_str': 'Alcoholic mixed drink'}, {'cui': 'C3816748', 'cui_str': '600'}, {'cui': 'C0023791', 'cui_str': 'alpha-lipoic acid'}, {'cui': 'C0003968', 'cui_str': 'Ascorbic Acid'}, {'cui': 'C0042874', 'cui_str': 'Vitamin E'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0005508', 'cui_str': 'Bioavailability'}, {'cui': 'C0232337', 'cui_str': 'Vascular function'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C0086597', 'cui_str': 'Mediate (qualifier value)'}, {'cui': 'C1322279', 'cui_str': 'Dilation'}, {'cui': 'C0178824', 'cui_str': 'Reactive Hyperemia'}, {'cui': 'C0175630', 'cui_str': 'Circulating (qualifier value)'}, {'cui': 'C0005516', 'cui_str': 'Biological Markers'}, {'cui': 'C0201657', 'cui_str': 'C-reactive protein measurement (procedure)'}, {'cui': 'C0242606', 'cui_str': 'Oxidative Stress'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0033684', 'cui_str': 'Proteins'}, {'cui': 'C0016693', 'cui_str': 'Free Radicals'}, {'cui': 'C0086045', 'cui_str': 'Concentration'}, {'cui': 'C2713504', 'cui_str': 'Spectroscopy'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0857241', 'cui_str': 'Ascorbate'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0028125', 'cui_str': 'Nitrates'}, {'cui': 'C0028137', 'cui_str': 'Nitrites'}, {'cui': 'C0441247', 'cui_str': 'Conduit (physical object)'}, {'cui': 'C0003842', 'cui_str': 'Arteries'}, {'cui': 'C0042401', 'cui_str': 'Vasorelaxation'}]",,0.237953,"Circulating biomarkers of inflammation (C-reactive protein, CRP), oxidative stress (Malondialdehyde and Protein Carbonyl), free radical concentration (EPR Spectroscopy), antioxidant capacity, ascorbate and NO bioavailability (plasma nitrate, NO 3 - , and nitrite, NO 2 - ) were also assessed. ","[{'ForeName': 'Stephen M', 'Initials': 'SM', 'LastName': 'Ratchford', 'Affiliation': 'Geriatric Research, Education, and Clinical Center, George E. Whalen Veterans Affairs Medical Center, Salt Lake City, Utah.'}, {'ForeName': 'Heather L', 'Initials': 'HL', 'LastName': 'Clifton', 'Affiliation': 'Geriatric Research, Education, and Clinical Center, George E. Whalen Veterans Affairs Medical Center, Salt Lake City, Utah.'}, {'ForeName': 'Jayson R', 'Initials': 'JR', 'LastName': 'Gifford', 'Affiliation': 'Department of Exercise Sciences, Brigham Young University, Provo, Utah.'}, {'ForeName': 'D Taylor', 'Initials': 'DT', 'LastName': 'LaSalle', 'Affiliation': 'Department of Nutrition and Integrative Physiology, University of Utah, Salt Lake City, Utah.'}, {'ForeName': 'Taylor S', 'Initials': 'TS', 'LastName': 'Thurston', 'Affiliation': 'Department of Nutrition and Integrative Physiology, University of Utah, Salt Lake City, Utah.'}, {'ForeName': 'Kanokwan', 'Initials': 'K', 'LastName': 'Bunsawat', 'Affiliation': 'Department of Internal Medicine, Division of Geriatrics, University of Utah, Salt Lake City, Utah.'}, {'ForeName': 'Jeremy K', 'Initials': 'JK', 'LastName': 'Alpenglow', 'Affiliation': 'Department of Nutrition and Integrative Physiology, University of Utah, Salt Lake City, Utah.'}, {'ForeName': 'Russell S', 'Initials': 'RS', 'LastName': 'Richardson', 'Affiliation': 'Geriatric Research, Education, and Clinical Center, George E. Whalen Veterans Affairs Medical Center, Salt Lake City, Utah.'}, {'ForeName': 'Josephine B', 'Initials': 'JB', 'LastName': 'Wright', 'Affiliation': 'Department of Internal Medicine, Division of Cardiovascular Medicine, University of Utah, Salt Lake City, Utah.'}, {'ForeName': 'John J', 'Initials': 'JJ', 'LastName': 'Ryan', 'Affiliation': 'Department of Internal Medicine, Division of Cardiovascular Medicine, University of Utah, Salt Lake City, Utah.'}, {'ForeName': 'D Walter', 'Initials': 'DW', 'LastName': 'Wray', 'Affiliation': 'Geriatric Research, Education, and Clinical Center, George E. Whalen Veterans Affairs Medical Center, Salt Lake City, Utah.'}]","American journal of physiology. Regulatory, integrative and comparative physiology",['10.1152/ajpregu.00184.2019'] 3321,31023398,Dimensions of anxiety in Major depressive disorder and their use in predicting antidepressant treatment outcome: an iSPOT-D report.,"BACKGROUND Major depressive disorder (MDD) commonly co-occurs with clinically significant levels of anxiety. However, anxiety symptoms are varied and have been inconsistently associated with clinical, functional, and antidepressant treatment outcomes. We aimed to identify and characterise dimensions of anxiety in people with MDD and their use in predicting antidepressant treatment outcome. METHOD 1008 adults with a current diagnosis of single-episode or recurrent, nonpsychotic, MDD were assessed at baseline on clinical features and cognitive/physiological functioning. Participants were then randomised to one of three commonly prescribed antidepressants and reassessed at 8 weeks regarding symptom change, as well as remission and response, on the 17-item Hamilton Rating Scale Depression (HRSD17) and the 16-item Quick Inventory of Depressive Symptomatology (QIDS-SR16). Exploratory factor analysis was used on items from scales assessing anxiety symptoms, and resulting factors were assessed against clinical features and cognitive/physiological functioning. Factors were also assessed on their ability to predict treatment outcome. RESULTS Three factors emerged relating to stress, cognitive anxiety, and somatic anxiety. All factors showed high internal consistency, minimal cross-loadings, and unique clinical and functional profiles. Furthermore, only higher somatic anxiety was associated with poorer QIDS-SR16 remission, even after adjusting for covariates and multiple comparisons. CONCLUSIONS Anxiety symptoms in people with MDD can be separated onto distinct factors that differentially respond to treatment outcome. Furthermore, these factors do not align with subscales of established measures of anxiety. Future research should consider cognitive and somatic symptoms of anxiety separately when assessing anxiety in MDD and their use in predicting treatment outcome.",2020,"Furthermore, only higher somatic anxiety was associated with poorer QIDS-SR16 remission, even after adjusting for covariates and multiple comparisons. ","['1008 adults with a current diagnosis of single-episode or recurrent, nonpsychotic, MDD were assessed at baseline on clinical features and cognitive/physiological functioning', 'people with MDD']",[],"['stress, cognitive anxiety, and somatic anxiety', 'anxiety symptoms', 'somatic anxiety', '17-item Hamilton Rating Scale Depression (HRSD17) and the 16-item Quick Inventory of Depressive Symptomatology (QIDS-SR16', 'poorer QIDS-SR16 remission']","[{'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0521116', 'cui_str': 'Current (qualifier value)'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0556986', 'cui_str': 'Single episode (qualifier value)'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0205463', 'cui_str': 'Physiologic (qualifier value)'}]",[],"[{'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C0003467', 'cui_str': 'Anxiety'}, {'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0222045'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C4720917', 'cui_str': 'Quick inventory of depressive symptomatology (assessment scale)'}, {'cui': 'C0542537', 'cui_str': 'Poor - grade'}, {'cui': 'C0544452', 'cui_str': 'Remission phase (qualifier value)'}]",1008.0,0.053008,"Furthermore, only higher somatic anxiety was associated with poorer QIDS-SR16 remission, even after adjusting for covariates and multiple comparisons. ","[{'ForeName': 'Taylor A', 'Initials': 'TA', 'LastName': 'Braund', 'Affiliation': 'Brain Dynamics Centre, The Westmead Institute for Medical Research, Sydney, NSW, Australia.'}, {'ForeName': 'Donna M', 'Initials': 'DM', 'LastName': 'Palmer', 'Affiliation': 'Brain Dynamics Centre, The Westmead Institute for Medical Research, Sydney, NSW, Australia.'}, {'ForeName': 'Leanne M', 'Initials': 'LM', 'LastName': 'Williams', 'Affiliation': 'Department of Psychiatry and Behavioral Sciences, Stanford University, Stanford, CA, USA.'}, {'ForeName': 'Anthony W F', 'Initials': 'AWF', 'LastName': 'Harris', 'Affiliation': 'Brain Dynamics Centre, The Westmead Institute for Medical Research, Sydney, NSW, Australia.'}]",Psychological medicine,['10.1017/S0033291719000941'] 3322,30891605,Impact of Microscopic and Submicroscopic Parasitemia During Pregnancy on Placental Malaria in a High-Transmission Setting in Uganda.,"BACKGROUND Placental malaria is a major cause of adverse birth outcomes. However, data are limited on the relationships between longitudinal measures of parasitemia during pregnancy and placental malaria. METHODS Data came from 637 women enrolled in a randomized controlled trial of intermittent preventive treatment of malaria in pregnancy (IPTp) from Uganda. Plasmodium falciparum parasitemia was assessed using microscopy and ultrasensitive quantitative PCR at intervals of 28 days from 12 to 20 weeks gestation through delivery. Multivariate analysis was used to measure associations between characteristics of parasitemia during pregnancy and the risk of placental malaria based on histopathology. RESULTS Overall risk of placental malaria was 44.6%. None of the 34 women without parasitemia detected during pregnancy had evidence of placental malaria. Increasing proportion of interval assessments with parasitemia and higher parasite densities were independently associated with an increased risk of placental malaria. Higher gravidity and more effective IPTp were associated with a decreased risk of placental malaria. Women with parasitemia only detected before the third trimester still had an increased risk of placental malaria. CONCLUSIONS The frequency, density, and timing of parasitemia are all important risk factors for placental malaria. Interventions should target the prevention of all levels of parasitemia throughout pregnancy.",2019,Plasmodium falciparum parasitemia was assessed using microscopy and ultrasensitive quantitative PCR at intervals of 28 days from 12-20 weeks gestation through delivery.,"['Uganda', '637 women enrolled in a randomized controlled trial of intermittent preventive treatment of malaria in pregnancy (IPTp) from Uganda']",[],"['risk of placental malaria', 'frequency, density, and timing of parasitemia', 'placental malaria', 'Overall risk of placental malaria', 'Plasmodium falciparum parasitemia']","[{'cui': 'C0041573', 'cui_str': 'Republic of Uganda'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0205267', 'cui_str': 'Intermittent (qualifier value)'}, {'cui': 'C0199176', 'cui_str': 'Prophylaxis - procedure intent (qualifier value)'}, {'cui': 'C0024530', 'cui_str': 'Plasmodium Infections'}, {'cui': 'C0032961', 'cui_str': 'Gestation'}]",[],"[{'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0024530', 'cui_str': 'Plasmodium Infections'}, {'cui': 'C0376249', 'cui_str': 'Frequency (attribute)'}, {'cui': 'C0178587', 'cui_str': 'Mass to volume ratio'}, {'cui': 'C0449243', 'cui_str': 'Timing (attribute)'}, {'cui': 'C0242723', 'cui_str': 'Parasitemia'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0032150', 'cui_str': 'Plasmodium falciparum'}]",637.0,0.095087,Plasmodium falciparum parasitemia was assessed using microscopy and ultrasensitive quantitative PCR at intervals of 28 days from 12-20 weeks gestation through delivery.,"[{'ForeName': 'Jessica', 'Initials': 'J', 'LastName': 'Briggs', 'Affiliation': 'Department of Medicine, University of California San Francisco.'}, {'ForeName': 'John', 'Initials': 'J', 'LastName': 'Ategeka', 'Affiliation': 'Infectious Diseases Research Collaboration, Kampala, Uganda.'}, {'ForeName': 'Richard', 'Initials': 'R', 'LastName': 'Kajubi', 'Affiliation': 'Infectious Diseases Research Collaboration, Kampala, Uganda.'}, {'ForeName': 'Teddy', 'Initials': 'T', 'LastName': 'Ochieng', 'Affiliation': 'Infectious Diseases Research Collaboration, Kampala, Uganda.'}, {'ForeName': 'Abel', 'Initials': 'A', 'LastName': 'Kakuru', 'Affiliation': 'Infectious Diseases Research Collaboration, Kampala, Uganda.'}, {'ForeName': 'Cephus', 'Initials': 'C', 'LastName': 'Ssemanda', 'Affiliation': 'Infectious Diseases Research Collaboration, Kampala, Uganda.'}, {'ForeName': 'Razack', 'Initials': 'R', 'LastName': 'Wasswa', 'Affiliation': 'Infectious Diseases Research Collaboration, Kampala, Uganda.'}, {'ForeName': 'Prasanna', 'Initials': 'P', 'LastName': 'Jagannathan', 'Affiliation': 'Department of Medicine, Stanford University, California.'}, {'ForeName': 'Bryan', 'Initials': 'B', 'LastName': 'Greenhouse', 'Affiliation': 'Department of Medicine, University of California San Francisco.'}, {'ForeName': 'Isabel', 'Initials': 'I', 'LastName': 'Rodriguez-Barraquer', 'Affiliation': 'Department of Medicine, University of California San Francisco.'}, {'ForeName': 'Moses', 'Initials': 'M', 'LastName': 'Kamya', 'Affiliation': 'Infectious Diseases Research Collaboration, Kampala, Uganda.'}, {'ForeName': 'Grant', 'Initials': 'G', 'LastName': 'Dorsey', 'Affiliation': 'Department of Medicine, University of California San Francisco.'}]",The Journal of infectious diseases,['10.1093/infdis/jiz130'] 3323,30535534,"The Effects of Probiotic Supplementation on Genetic and Metabolic Profiles in Patients with Gestational Diabetes Mellitus: a Randomized, Double-Blind, Placebo-Controlled Trial.","This study was carried out to evaluate the effects of probiotic supplementation on genetic and metabolic profiles in patients with gestational diabetes mellitus (GDM) who were not on oral hypoglycemic agents. This randomized, double-blind, placebo-controlled clinical trial was conducted in 48 patients with GDM. Participants were randomly divided into two groups to intake either probiotic capsule containing Lactobacillus acidophilus, Lactobacillus casei, Bifidobacterium bifidum, Lactobacillus fermentum (2 × 10 9  CFU/g each) (n = 24) or placebo (n = 24) for 6 weeks. Probiotic intake upregulated peroxisome proliferator-activated receptor gamma (P = 0.01), transforming growth factor beta (P = 0.002) and vascular endothelial growth factor (P = 0.006), and downregulated gene expression of tumor necrosis factor alpha (P = 0.03) in peripheral blood mononuclear cells of subjects with GDM. In addition, probiotic supplementation significantly decreased fasting plasma glucose (β, - 3.43 mg/dL; 95% CI, - 6.48, - 0.38; P = 0.02), serum insulin levels (β, - 2.29 μIU/mL; 95% CI, - 3.60, - 0.99; P = 0.001), and insulin resistance (β, - 0.67; 95% CI, - 1.05, - 0.29; P = 0.001) and significantly increased insulin sensitivity (β, 0.009; 95% CI, 0.004, 0.01; P = 0.001) compared with the placebo. Additionally, consuming probiotic significantly decreased triglycerides (P = 0.02), VLDL-cholesterol (P = 0.02), and total-/HDL-cholesterol ratio (P = 0.006) and significantly increased HDL-cholesterol levels (P = 0.03) compared with the placebo. Finally, probiotic administration led to a significant reduction in plasma malondialdehyde (P < 0.001), and a significant elevation in plasma nitric oxide (P = 0.01) and total antioxidant capacity (P = 0.01) was observed compared with the placebo. Overall, probiotic supplementation for 6 weeks to patients with GDM had beneficial effects on gene expression related to insulin and inflammation, glycemic control, few lipid profiles, inflammatory markers, and oxidative stress.",2019,"Probiotic intake upregulated peroxisome proliferator-activated receptor gamma (P = 0.01), transforming growth factor beta (P = 0.002) and vascular endothelial growth factor (P = 0.006), and downregulated gene expression of tumor necrosis factor alpha (P = 0.03) in peripheral blood mononuclear cells of subjects with GDM.","['48 patients with GDM', 'Patients with Gestational Diabetes Mellitus', 'patients with gestational diabetes mellitus (GDM) who were not on oral hypoglycemic agents']","['placebo', 'Placebo', 'probiotic capsule containing Lactobacillus acidophilus, Lactobacillus casei, Bifidobacterium bifidum, Lactobacillus fermentum', 'probiotic supplementation', 'Probiotic Supplementation']","['triglycerides', 'plasma nitric oxide', 'insulin sensitivity', 'VLDL-cholesterol', 'serum insulin levels', 'transforming growth factor beta', 'vascular endothelial growth factor', 'downregulated gene expression of tumor necrosis factor alpha', 'Genetic and Metabolic Profiles', 'insulin resistance', 'peripheral blood mononuclear cells', 'genetic and metabolic profiles', 'total-/HDL-cholesterol ratio', 'insulin and inflammation, glycemic control, few lipid profiles, inflammatory markers, and oxidative stress', 'total antioxidant capacity', 'HDL-cholesterol levels', 'plasma malondialdehyde', 'fasting plasma glucose']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0085207', 'cui_str': 'Diabetes, Pregnancy-Induced'}, {'cui': 'C4521986', 'cui_str': 'Oral (intended site)'}, {'cui': 'C0020616', 'cui_str': 'Hypoglycemic Drugs'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0525033', 'cui_str': 'Probiotics'}, {'cui': 'C4319574', 'cui_str': 'Capsule'}, {'cui': 'C0332256', 'cui_str': 'Containing (qualifier value)'}, {'cui': 'C0022939', 'cui_str': 'Lactobacillus acidophilus'}, {'cui': 'C0022940', 'cui_str': 'Lactobacillus casei'}, {'cui': 'C0314974', 'cui_str': 'Bifidobacterium bifidum'}, {'cui': 'C0317603', 'cui_str': 'Lactobacillus fermentum'}]","[{'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0032105', 'cui_str': 'Blood Plasma'}, {'cui': 'C0028128', 'cui_str': 'Nitric Oxide'}, {'cui': 'C0920563', 'cui_str': 'Insulin Sensitivity'}, {'cui': 'C0023826', 'cui_str': 'Pre-beta-Lipoprotein Cholesterol'}, {'cui': 'C0428357', 'cui_str': 'Serum insulin measurement'}, {'cui': 'C0040690', 'cui_str': 'Bone-Derived Transforming Growth Factor'}, {'cui': 'C0078058', 'cui_str': 'Vascular Endothelial Growth Factor A'}, {'cui': 'C0017262', 'cui_str': 'Gene Expression'}, {'cui': 'C1456820', 'cui_str': 'Tumor Necrosis Factor-alpha'}, {'cui': 'C0017399', 'cui_str': 'genetics'}, {'cui': 'C3853758', 'cui_str': 'Metabolic Profile'}, {'cui': 'C0021655', 'cui_str': 'Insulin Resistance'}, {'cui': 'C1321301', 'cui_str': 'Peripheral blood mononuclear cell'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0008377', 'cui_str': 'Cholesterol'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C0202098', 'cui_str': 'Insulin measurement (procedure)'}, {'cui': 'C0021368', 'cui_str': 'Inflammation'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0023779', 'cui_str': 'Lipids'}, {'cui': 'C0242606', 'cui_str': 'Oxidative Stress'}, {'cui': 'C0003402', 'cui_str': 'Anti-Oxidants'}, {'cui': 'C0018667', 'cui_str': 'Cholesterol, HDL2'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0024643', 'cui_str': 'Malondialdehyde'}, {'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C0202042', 'cui_str': 'Glucose measurement, plasma (procedure)'}]",48.0,0.444059,"Probiotic intake upregulated peroxisome proliferator-activated receptor gamma (P = 0.01), transforming growth factor beta (P = 0.002) and vascular endothelial growth factor (P = 0.006), and downregulated gene expression of tumor necrosis factor alpha (P = 0.03) in peripheral blood mononuclear cells of subjects with GDM.","[{'ForeName': 'Mahtab', 'Initials': 'M', 'LastName': 'Babadi', 'Affiliation': 'Department of Microbiology and Immunology, School of Medicine, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Ahmad', 'Initials': 'A', 'LastName': 'Khorshidi', 'Affiliation': 'Department of Microbiology and Immunology, School of Medicine, Kashan University of Medical Sciences, Kashan, Iran. khorshidi_a@kaums.ac.ir.'}, {'ForeName': 'Esmat', 'Initials': 'E', 'LastName': 'Aghadavood', 'Affiliation': 'Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences, Kashan, I.R., Iran.'}, {'ForeName': 'Mansooreh', 'Initials': 'M', 'LastName': 'Samimi', 'Affiliation': 'Department of Gynecology and Obstetrics, School of Medicine, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Elham', 'Initials': 'E', 'LastName': 'Kavossian', 'Affiliation': 'Department of Gynecology and Obstetrics, School of Medicine, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Fereshteh', 'Initials': 'F', 'LastName': 'Bahmani', 'Affiliation': 'Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences, Kashan, I.R., Iran.'}, {'ForeName': 'Alireza', 'Initials': 'A', 'LastName': 'Mafi', 'Affiliation': 'Department of Microbiology and Immunology, School of Medicine, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Rana', 'Initials': 'R', 'LastName': 'Shafabakhsh', 'Affiliation': 'Department of Microbiology and Immunology, School of Medicine, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Mahbobeh', 'Initials': 'M', 'LastName': 'Satari', 'Affiliation': 'Department of Microbiology and Immunology, School of Medicine, Kashan University of Medical Sciences, Kashan, Iran.'}, {'ForeName': 'Zatollah', 'Initials': 'Z', 'LastName': 'Asemi', 'Affiliation': 'Research Center for Biochemistry and Nutrition in Metabolic Diseases, Kashan University of Medical Sciences, Kashan, I.R., Iran. asemi_r@yahoo.com.'}]",Probiotics and antimicrobial proteins,['10.1007/s12602-018-9490-z'] 3324,31153846,Absorb Bioresorbable Scaffold Versus Xience Metallic Stent for Prevention of Restenosis Following Percutaneous Coronary Intervention in Patients at High Risk of Restenosis: Rationale and Design of the COMPARE ABSORB Trial.,"BACKGROUND The advent of bioresorbable vascular scaffolds (BVS) was considered as a potential improvement in percutaneous coronary intervention (PCI) after the groundbreaking development of drug eluting stents (DES). However, the clinical performance, long-term safety and efficacy of BVS in complex coronary lesions remain uncertain. COMPARE ABSORB, a multicenter, single blind, prospective randomized trial, aims to compare the clinical outcomes between the Absorb BVS and Xience everolimus-eluting metallic stent (EES) in patients with coronary artery disease and a high risk of restenosis. DESIGN COMPARE ABSORB is designed to enroll 2100 patients at up to 45 European sites. Enrolled patients will possess high risk for restenosis due to clinical profile or coronary lesion complexity and will undergo elective or emergent PCI. Once included in the study, patients will receive either Absorb BVS or Xience EES. Specific advice on implantation technique including mandatory pre-dilatation, sizing and post-dilatation (PSP), will be used in the Absorb BVS arm. The primary endpoint is target lesion failure (TLF), a device-oriented composite endpoint (cardiac death, target vessel myocardial infarction and clinically-indicated target lesion revascularization). The trial is powered to assess non-inferiority of Absorb BVS compared with Xience EES with a predetermined non-inferiority margin of 4.5% at 1 year after index procedure. The clinical follow-up will continue for 7 years. CONCLUSIONS The prospective COMPARE ABSORB randomized trial (ClinicalTrials.govNCT02486068) will help to assess the long-term safety and efficacy of Absorb BVS compared with Xience EES in the treatments of patients with complex coronary artery disease and a high attendant risk of restenosis.",2019,"The primary endpoint is target lesion failure (TLF), a device-oriented composite endpoint (cardiac death, target vessel myocardial infarction and clinically-indicated target lesion revascularization).","['Enrolled patients will possess high risk for restenosis due to clinical profile or coronary lesion complexity and will undergo elective or emergent PCI', 'patients with complex coronary artery disease and a high attendant risk of restenosis', 'patients at high risk of restenosis', 'patients with coronary artery disease and a high risk of restenosis', 'enroll 2100 patients at up to 45 European sites']","['Absorb BVS', 'Specific advice on implantation technique including mandatory pre-dilatation, sizing and post-dilatation (PSP', 'Absorb BVS and Xience everolimus-eluting metallic stent (EES', 'percutaneous coronary intervention', 'Xience EES', 'Absorb bioresorbable scaffold versus Xience metallic stent', 'Absorb BVS or Xience EES', 'BVS']","['target lesion failure (TLF), a device-oriented composite endpoint (cardiac death, target vessel myocardial infarction and clinically-indicated target lesion revascularization']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4319571', 'cui_str': 'High risk (qualifier value)'}, {'cui': 'C0333186', 'cui_str': 'Restenosis'}, {'cui': 'C0678226', 'cui_str': 'Due to (attribute)'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0221198', 'cui_str': 'Lesion (morphologic abnormality)'}, {'cui': 'C0439608', 'cui_str': 'Elective (qualifier value)'}, {'cui': 'C0439855', 'cui_str': 'Complex (qualifier value)'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0035647', 'cui_str': 'Risk'}, {'cui': 'C0332167', 'cui_str': 'High risk of (contextual qualifier) (qualifier value)'}, {'cui': 'C0239307', 'cui_str': 'European (ethnic group)'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}]","[{'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0021107', 'cui_str': 'Insertion procedure'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}, {'cui': 'C0740175', 'cui_str': 'Before values (qualifier value)'}, {'cui': 'C1322279', 'cui_str': 'Dilation'}, {'cui': 'C0687676', 'cui_str': 'After values (qualifier value)'}, {'cui': 'C1868193', 'cui_str': 'PSP'}, {'cui': 'C0541315', 'cui_str': 'everolimus'}, {'cui': 'C0038257', 'cui_str': 'Stents'}, {'cui': 'C1532338', 'cui_str': 'Percutaneous Coronary Revascularization'}, {'cui': 'C0337143', 'cui_str': 'Scaffold, device (physical object)'}]","[{'cui': 'C0014742', 'cui_str': 'Erythema Multiforme'}, {'cui': 'C0231174', 'cui_str': 'Failure (finding)'}, {'cui': 'C0220819', 'cui_str': 'devices'}, {'cui': 'C0205199', 'cui_str': 'Composite (qualifier value)'}, {'cui': 'C0376297', 'cui_str': 'Cardiac Death'}, {'cui': 'C0449618', 'cui_str': 'Target vessel (attribute)'}, {'cui': 'C0027051', 'cui_str': 'Heart Attack'}, {'cui': 'C1444656', 'cui_str': 'Indicated'}, {'cui': 'C0581603', 'cui_str': 'Revascularization - action (qualifier value)'}]",,0.113332,"The primary endpoint is target lesion failure (TLF), a device-oriented composite endpoint (cardiac death, target vessel myocardial infarction and clinically-indicated target lesion revascularization).","[{'ForeName': 'Chun Chin', 'Initials': 'CC', 'LastName': 'Chang', 'Affiliation': 'Thoraxcenter, Erasmus University Medical Center, Rotterdam, the Netherlands; Division of Cardiology, Department of Medicine, Taipei Veterans General Hospital, Taiwan.'}, {'ForeName': 'Yoshinobu', 'Initials': 'Y', 'LastName': 'Onuma', 'Affiliation': 'Thoraxcenter, Erasmus University Medical Center, Rotterdam, the Netherlands; Cardialysis Clinical Trials Management and Core Laboratories, Rotterdam, the Netherlands.'}, {'ForeName': 'Stephan', 'Initials': 'S', 'LastName': 'Achenbach', 'Affiliation': 'Department of Cardiology, Universitätsklinikum Erlangen, Erlangen, Germany.'}, {'ForeName': 'Emanuele', 'Initials': 'E', 'LastName': 'Barbato', 'Affiliation': 'Cardiovascular Research Center OLV Hospital, Aalst, Belgium.'}, {'ForeName': 'Bernard', 'Initials': 'B', 'LastName': 'Chevalier', 'Affiliation': 'Ramsay Générale de Santé, ICPS, Hôpital Jacques Cartier, Massy, France.'}, {'ForeName': 'Stéphane', 'Initials': 'S', 'LastName': 'Cook', 'Affiliation': 'Department of Cardiology, Hospital and University Fribourg, Switzerland.'}, {'ForeName': 'Dariusz', 'Initials': 'D', 'LastName': 'Dudek', 'Affiliation': '2nd Department of Cardiology, Jagiellonian University Medical College, Krakow, Poland.'}, {'ForeName': 'Javier', 'Initials': 'J', 'LastName': 'Escaned', 'Affiliation': 'Hospital Clinico San Carlos IDISSC, Complutense University, Madrid, Spain.'}, {'ForeName': 'Tommaso', 'Initials': 'T', 'LastName': 'Gori', 'Affiliation': 'Center of Cardiology, Cardiology I, University Medical Center of the Johannes Gutenberg-University Mainz and DZHK Standort Rhein-Main, Mainz, Germany.'}, {'ForeName': 'Viktor', 'Initials': 'V', 'LastName': 'Kočka', 'Affiliation': 'Third Faculty of Medicine, Charles University and University Hospital Královske Vinohrady, Prague, Czech Republic.'}, {'ForeName': 'Giuseppe', 'Initials': 'G', 'LastName': 'Tarantini', 'Affiliation': 'Interventional Cardiology Unit, Department of Cardiac, Thoracic and Vascular Sciences, University of Padua, Italy.'}, {'ForeName': 'Nick E J', 'Initials': 'NEJ', 'LastName': 'West', 'Affiliation': 'Department of Interventional Cardiology, Royal Papworth Hospital, UK.'}, {'ForeName': 'Marie-Claude', 'Initials': 'MC', 'LastName': 'Morice', 'Affiliation': 'Ramsay Générale de Santé, Hopital Privé Jacques Cartier, Massy, France.'}, {'ForeName': 'Jan G P', 'Initials': 'JGP', 'LastName': 'Tijssen', 'Affiliation': 'Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands.'}, {'ForeName': 'Robert-Jan', 'Initials': 'RJ', 'LastName': 'van Geuns', 'Affiliation': 'Thoraxcenter, Erasmus University Medical Center, Rotterdam, the Netherlands; Cardiology Department, Radboud UMC, Nijmegen, the Netherlands.'}, {'ForeName': 'Pieter C', 'Initials': 'PC', 'LastName': 'Smits', 'Affiliation': 'Cardiology Department, Maasstad Hospital, Rotterdam, the Netherlands. Electronic address: SmitsP@maasstadziekenhuis.nl.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Cardiovascular revascularization medicine : including molecular interventions,['10.1016/j.carrev.2019.04.013'] 3325,31838406,A multicentric randomized phase II clinical trial evaluating high-dose thiotepa as adjuvant treatment to standard chemotherapy in patients with resectable relapsed osteosarcoma.,"BACKGROUND The role of high-dose chemotherapy in relapsing osteosarcomas has not been established. We evaluated the efficacy and tolerance of high-dose thiotepa (HDTp) after standard chemotherapy (SCT) in patients with relapsed osteosarcoma. PATIENTS AND METHODS This randomised open-label phase II study enrolled patients 1-50 years, with local or metastatic relapse of a high-grade osteosarcoma, not progressive after two cycles of SCT, for whom a complete surgery can be achievable following treatment. The trial assigned enrolled patients in a 1:1 ratio to receive two additional courses of SCT + HDTp and autologous transplantation (Arm A), or SCT alone (Arm B). Surgery for complete resection was scheduled as soon as feasible. Primary endpoint was overall survival (OS). Secondary objectives included progression-free survival (PFS) and safety. RESULTS From September 2009 to November 2016, 44 patients were randomised (A:22; B:22). In total, 54.5% were males, and the median age was 16 years (9-32years). The two-year OS rate was 66.7% (95% CI 42.5-82.5) (SCT + HDTp, Arm A) versus 50.0% (95% CI 28.2-68.4) for SCT alone (Arm B). Median OS was 27.4 and 24.8 months, respectively (hazard ratio [HR] 0.826, 95% CI 0.393-1.734; p = 0.6123). Median PFS was 15.6 (8.9-24.9) months in Arm A versus 7.2 (4.8-33.3) months in Arm B, p = 0.3845. Among the 22 patients treated with SCT + HDTp, 16 (72.7%) experienced at least one grade ≥3 adverse events versus 18/22 (81.8%) patients treated with SCT. No toxic death occurred. CONCLUSION Adjuvant HDTp failed to significantly improve OS and PFS in resectable relapsed osteosarcomas. Despite a trend of prolonged survival and an acceptable toxicity, thiotepa cannot be recommended. KEY MESSAGE HDTp and autologous transplantation added to SCT did not improve OS and PFS in patients with resectable relapsed osteosarcomas. Despite a trend of prolonged survival, thiotepa cannot be recommended.",2020,"The two-year OS rate was 66.7% (95% CI 42.5-82.5) (SCT + HDTp, Arm A) versus 50.0% (95% CI 28.2-68.4) for SCT alone (Arm B).","['patients with resectable relapsed osteosarcoma', 'From September 2009 to November 2016, 44 patients', 'In total, 54.5% were males, and the median age was 16 years (9-32years', 'patients with relapsed osteosarcoma', 'patients with resectable relapsed osteosarcomas', 'enrolled patients 1-50 years, with local or metastatic relapse of a high-grade osteosarcoma, not progressive after two cycles of SCT, for whom a complete surgery can be achievable following treatment']","['standard chemotherapy', 'SCT', 'SCT\xa0+\xa0HDTp and autologous transplantation (Arm A), or SCT alone', 'high-dose thiotepa (HDTp) after standard chemotherapy (SCT']","['prolonged survival', 'efficacy and tolerance', 'grade ≥3 adverse events', 'OS and PFS', 'progression-free survival (PFS)\xa0and safety', 'overall survival (OS', 'toxic death', 'Median OS', 'Median PFS', 'OS rate']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0029463', 'cui_str': 'Sarcoma, Osteogenic'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0205276', 'cui_str': 'Local (qualifier value)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C1962917', 'cui_str': 'High grade (lymphoma)'}, {'cui': 'C0205329', 'cui_str': 'Progressive (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}, {'cui': 'C0332282', 'cui_str': 'Following (attribute)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C0038137', 'cui_str': 'standards'}, {'cui': 'C0013217', 'cui_str': 'pharmacotherapy'}, {'cui': 'C0040736', 'cui_str': 'Autotransplantation'}, {'cui': 'C1140618', 'cui_str': 'Membrum superius'}, {'cui': 'C0444956', 'cui_str': 'High dose (qualifier value)'}, {'cui': 'C0039871', 'cui_str': 'Thiotepa'}]","[{'cui': 'C0439590', 'cui_str': 'Prolonged (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C0231197', 'cui_str': 'Tolerance, function (observable entity)'}, {'cui': 'C0441800', 'cui_str': 'Grading (attribute)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]",44.0,0.152844,"The two-year OS rate was 66.7% (95% CI 42.5-82.5) (SCT + HDTp, Arm A) versus 50.0% (95% CI 28.2-68.4) for SCT alone (Arm B).","[{'ForeName': 'Perrine', 'Initials': 'P', 'LastName': 'Marec-Berard', 'Affiliation': 'Paediatric Department, Hematology and Oncology Pediatric Institute, Centre Léon Bérard, Lyon, France. Electronic address: perrine.marec-berard@ihope.fr.'}, {'ForeName': 'Cécile', 'Initials': 'C', 'LastName': 'Dalban', 'Affiliation': 'Department of Clinical Research and Innovation, Centre Léon Bérard, Lyon, France.'}, {'ForeName': 'Nathalie', 'Initials': 'N', 'LastName': 'Gaspar', 'Affiliation': 'Department of Pediatrics and Adolescents Oncology, Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Laurence', 'Initials': 'L', 'LastName': 'Brugieres', 'Affiliation': 'Department of Pediatrics and Adolescents Oncology, Gustave Roussy, Villejuif, France.'}, {'ForeName': 'Jean-Claude', 'Initials': 'JC', 'LastName': 'Gentet', 'Affiliation': 'Department of Pediatric Hematology and Oncology, La Timone Hospital, Marseille, France.'}, {'ForeName': 'Cyril', 'Initials': 'C', 'LastName': 'Lervat', 'Affiliation': 'Department of Pediatric Oncology, Centre Oscar Lambret, Lille, France.'}, {'ForeName': 'Nadège', 'Initials': 'N', 'LastName': 'Corradini', 'Affiliation': 'Department of Pediatric Hematology and Oncology, CHU Nantes, Nantes, France.'}, {'ForeName': 'Marie-Pierre', 'Initials': 'MP', 'LastName': 'Castex', 'Affiliation': 'Paediatric Department, Hospital Centre, Toulouse, France.'}, {'ForeName': 'Claudine', 'Initials': 'C', 'LastName': 'Schmitt', 'Affiliation': 'Pediatric Hospital, CHU Nancy, Vandoeuvre-les-Nancy, France.'}, {'ForeName': 'Hélène', 'Initials': 'H', 'LastName': 'Pacquement', 'Affiliation': 'Pediatric Oncology Department, Institut Curie, Paris, France.'}, {'ForeName': 'Marie-Dominique', 'Initials': 'MD', 'LastName': 'Tabone', 'Affiliation': 'Department of Pediatric Hematology and Oncology, A.Trousseau Hospital, APHP, Paris, France.'}, {'ForeName': 'Mehdi', 'Initials': 'M', 'LastName': 'Brahmi', 'Affiliation': 'Department of Medical Oncology, Centre Léon Bérard, Lyon, France.'}, {'ForeName': 'Séverine', 'Initials': 'S', 'LastName': 'Metzger', 'Affiliation': 'Department of Clinical Research and Innovation, Centre Léon Bérard, Lyon, France.'}, {'ForeName': 'Jean-Yves', 'Initials': 'JY', 'LastName': 'Blay', 'Affiliation': 'Department of Medical Oncology & Claude Bernard University, Centre Léon Bérard, Lyon, France.'}, {'ForeName': 'David', 'Initials': 'D', 'LastName': 'Pérol', 'Affiliation': 'Department of Clinical Research and Innovation, Centre Léon Bérard, Lyon, France.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2019.11.007'] 3326,29471904,Completion of isoniazid preventive therapy among human immunodeficiency virus positive adults in urban Malawi.,"SETTING Despite worldwide scale-up of human immunodeficiency virus (HIV) care services, relatively few countries have implemented isoniazid preventive therapy (IPT). Among other programmatic concerns, IPT completion tends to be low, especially when not fully integrated into HIV care clinics. OBJECTIVE To estimate non-completion of 6-month IPT and its predictors among HIV-positive adults aged 16 years. DESIGN A prospective cohort study nested within a cluster-randomised trial of TB prevention was conducted between February 2012 and June 2014. IPT for 6 months was provided with pyridoxine at study clinics. Non-completion was defined as loss to follow-up (LTFU), death, active/presumptive TB or stopping IPT for any other reason. Random-effects logistic regression was used to determine predictors of non-completion. RESULTS Of 1284 HIV-positive adults initiated on IPT, 885/1280 (69.1%) were female; the median CD4 count was 337 cells/μl (IQR 199-511); 320 (24.9%) did not complete IPT. After controlling for antiretroviral treatment status, IPT initiation year, age and sex, non-completion of IPT was associated with World Health Organization stage 3/4 (aOR 1.76, 95%CI 1.22-2.55), CD4 count 100-349 cells/μl (aOR 1.93, 95%CI 1.10-3.38) and any reported side effects (aOR 22.00, 95%CI 9.45-46.71). CONCLUSION Completion of IPT was suboptimal. Interventions to further improve retention should target immunosuppressed HIV-positive adults and address side effects.",2018,"After controlling for antiretroviral treatment status, IPT initiation year, age and sex, non-completion of IPT was associated with World Health Organization stage 3/4 (aOR 1.76, 95%CI 1.22-2.55), CD4 count 100-349 cells/μl (aOR 1.93, 95%CI 1.10-3.38) and any reported side effects (aOR 22.00, 95%CI 9.45-46.71). ","['February 2012 and June 2014', 'Despite worldwide scale-up of human immunodeficiency virus (HIV) care services', 'HIV-positive adults aged \ue2f616 years', 'human immunodeficiency virus positive adults in urban Malawi', 'Of 1284 HIV-positive adults']","['isoniazid preventive therapy', 'isoniazid preventive therapy (IPT', 'IPT', 'pyridoxine']","['CD4 count 100-349 cells/μl', 'loss to follow-up (LTFU), death, active/presumptive TB or stopping IPT', 'side effects', 'median CD4 count']","[{'cui': 'C0222045'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0557854', 'cui_str': 'Services (qualifier value)'}, {'cui': 'C0019699', 'cui_str': 'HTLV-III Seroconversion'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0442529', 'cui_str': 'Urban environment (environment)'}, {'cui': 'C0024548', 'cui_str': 'Republic of Malawi'}]","[{'cui': 'C0022209', 'cui_str': 'isoniazid'}, {'cui': 'C0033107', 'cui_str': 'prophylaxis'}, {'cui': 'C0380193', 'cui_str': 'iodine-123-IPT'}, {'cui': 'C0034272', 'cui_str': 'pyridoxine'}]","[{'cui': 'C0243009', 'cui_str': 'CD4+ Counts'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C0007634', 'cui_str': 'Cells'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}, {'cui': 'C0011065', 'cui_str': 'Death'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C0450446', 'cui_str': 'Stops (attribute)'}, {'cui': 'C0380193', 'cui_str': 'iodine-123-IPT'}, {'cui': 'C0001688', 'cui_str': 'side effects'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}]",,0.225933,"After controlling for antiretroviral treatment status, IPT initiation year, age and sex, non-completion of IPT was associated with World Health Organization stage 3/4 (aOR 1.76, 95%CI 1.22-2.55), CD4 count 100-349 cells/μl (aOR 1.93, 95%CI 1.10-3.38) and any reported side effects (aOR 22.00, 95%CI 9.45-46.71). ","[{'ForeName': 'D', 'Initials': 'D', 'LastName': 'Thindwa', 'Affiliation': 'Malawi-Liverpool-Wellcome Trust Clinical Research Programme, Blantyre, Malawi, Department of Infectious Disease Epidemiology, Imperial College London, London.'}, {'ForeName': 'P', 'Initials': 'P', 'LastName': 'MacPherson', 'Affiliation': 'Department of Clinical Sciences, Liverpool School of Tropical Medicine, Liverpool, Department of Public Health and Policy, University of Liverpool, Liverpool.'}, {'ForeName': 'A T', 'Initials': 'AT', 'LastName': 'Choko', 'Affiliation': 'Malawi-Liverpool-Wellcome Trust Clinical Research Programme, Blantyre, Malawi, Infectious Disease Epidemiology Department, London School of Hygiene & Tropical Medicine (LSHTM), London, UK.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Khundi', 'Affiliation': 'Malawi-Liverpool-Wellcome Trust Clinical Research Programme, Blantyre, Malawi.'}, {'ForeName': 'R', 'Initials': 'R', 'LastName': 'Sambakunsi', 'Affiliation': 'Malawi-Liverpool-Wellcome Trust Clinical Research Programme, Blantyre, Malawi.'}, {'ForeName': 'L G', 'Initials': 'LG', 'LastName': 'Ngwira', 'Affiliation': 'Malawi-Liverpool-Wellcome Trust Clinical Research Programme, Blantyre, Malawi.'}, {'ForeName': 'T', 'Initials': 'T', 'LastName': 'Kalua', 'Affiliation': 'Department of HIV/AIDS, Ministry of Health, Lilongwe, Malawi.'}, {'ForeName': 'E L', 'Initials': 'EL', 'LastName': 'Webb', 'Affiliation': 'Department of HIV/AIDS, Ministry of Health, Lilongwe, Malawi.'}, {'ForeName': 'E L', 'Initials': 'EL', 'LastName': 'Corbett', 'Affiliation': 'Malawi-Liverpool-Wellcome Trust Clinical Research Programme, Blantyre, Malawi, Clinical Research Department, LSHTM, London, UK.'}]",The international journal of tuberculosis and lung disease : the official journal of the International Union against Tuberculosis and Lung Disease,['10.5588/ijtld.17.0370'] 3327,31699569,"Insights into the variability of nasal potential difference, a biomarker of CFTR activity.","BACKGROUND Nasal potential difference (NPD) is used to evaluate CFTR function in vivo. We aimed to evaluate the intrasubject and intersubject variability of NPD measurements. METHODS We reviewed NPD tracings of 116 patients with CF enrolled in the placebo arm of a multicenter study. Patients carried at least one nonsense mutation and underwent repeated NPD tests every 16 weeks. NPD parameters included basal potential difference (basal PD), inhibition of sodium absorption by amiloride (Δ Amiloride), chloride (Cl - ) transport in response to a Cl - -free solution (Δ Low Cl - ), isoproterenol (Δ Isoproterenol), the sum of Δ Low Cl - and Δ Isoproterenol (Δ Low Cl - -Isoproterenol) and ATP (Δ ATP). RESULTS Basal PD and Δ Amiloride displayed the highest variabilities, mainly stemming from intercenter and intrasubject effect. Δ Low Cl - , Δ Isoproterenol and Δ Low Cl - -Isoproterenol demonstrated a large intrasubject variability but a smaller intersubject variability. The intrasubject measurement variability for Δ Low Cl - -Isoproterenol, was within ± 7.2 mV with 95% probability. It was greater in patients reporting ongoing pulmonary exacerbations. CONCLUSIONS The large intercenter variability of basal PD and Δ Amiloride highlights the operator-dependent aspect of these measurements. A difference greater than 7.2 mV in Δ Low Cl - -Isoproterenol in a given patient on CFTR modulator can be attributed, with 95% probability, to a treatment effect rather than to the variability inherent in the measurement.",2020,"The intrasubject measurement variability for Δ Low Cl - -Isoproterenol, was within ± 7.2 mV with 95% probability.",['116 patients with CF enrolled in the'],"['placebo', 'Amiloride']","['basal potential difference (basal PD), inhibition of sodium absorption by amiloride (Δ Amiloride), chloride (Cl - ) transport in response to a Cl - -free solution (Δ Low Cl - ), isoproterenol (Δ Isoproterenol']","[{'cui': 'C4517541', 'cui_str': '116 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0002502', 'cui_str': 'Amiloride'}]","[{'cui': 'C0205112', 'cui_str': 'Basal (qualifier value)'}, {'cui': 'C0021469', 'cui_str': 'Inhibition, function (observable entity)'}, {'cui': 'C3541959', 'cui_str': 'Sodium supplement (substance)'}, {'cui': 'C2347023', 'cui_str': 'Absorption'}, {'cui': 'C0002502', 'cui_str': 'Amiloride'}, {'cui': 'C0008203', 'cui_str': 'Chlorides'}, {'cui': 'C1317949', 'cui_str': 'Transport (physical object)'}, {'cui': 'C0037633', 'cui_str': 'Solutions'}, {'cui': 'C0205251', 'cui_str': 'Low (qualifier value)'}, {'cui': 'C0022245', 'cui_str': 'isoprenaline'}]",116.0,0.102191,"The intrasubject measurement variability for Δ Low Cl - -Isoproterenol, was within ± 7.2 mV with 95% probability.","[{'ForeName': 'Spyridoula', 'Initials': 'S', 'LastName': 'Kyrilli', 'Affiliation': 'Centre Maladies Rares Mucoviscidose, Hôpital Universitaire Necker-Enfants Malades, Assistance-Publique Hôpitaux de Paris, Paris, France.'}, {'ForeName': 'Theophraste', 'Initials': 'T', 'LastName': 'Henry', 'Affiliation': 'Bio-statistics Department, Hôpital Universitaire Necker-Enfants Malades, Paris, France.'}, {'ForeName': 'Michael', 'Initials': 'M', 'LastName': 'Wilschanski', 'Affiliation': 'Hadassah Medical center, Hebrew University, Jerusalem, Israel.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Fajac', 'Affiliation': 'AP-HP, Hopital Cochin, Physiology Department, Paris, France; UPRES EA 2511, Paris, France; Université Paris Sorbonne, Paris, France.'}, {'ForeName': 'Jane C', 'Initials': 'JC', 'LastName': 'Davies', 'Affiliation': 'CF and Chronic Lung Infection, National Heart and Lung Institute, Imperial College London, UK; Department of Paediatric Respiratory Medicine, Royal Brompton and Harefield NHS Foundation Trust, London, United Kingdom.'}, {'ForeName': 'Jean-Philippe', 'Initials': 'JP', 'LastName': 'Jais', 'Affiliation': 'Bio-statistics Department, Hôpital Universitaire Necker-Enfants Malades, Paris, France; Université Paris Sorbonne, Paris, France.'}, {'ForeName': 'Isabelle', 'Initials': 'I', 'LastName': 'Sermet-Gaudelus', 'Affiliation': 'Centre Maladies Rares Mucoviscidose, Hôpital Universitaire Necker-Enfants Malades, Assistance-Publique Hôpitaux de Paris, Paris, France; Université Paris Sorbonne, Paris, France; Institut Necker-Enfants Malades. INSERM U1151, Paris, France. Electronic address: isabelle.sermet@nck.aphp.fr.'}]",Journal of cystic fibrosis : official journal of the European Cystic Fibrosis Society,['10.1016/j.jcf.2019.09.015'] 3328,30798000,Positive effect of low dose vitamin D supplementation on growth of fetal bones: A randomized prospective study.,"The effect of vitamin D supplementation on growth of fetal bones during pregnancy is unclear. The aim of this study was to assess the effect of low dose vitamin D supplementation during pregnancy on bony anthropometric aspects of the fetus. In this prospective randomized trial, 140 patients were divided into two equally matched groups according to age, 25(OH)D level, exercise, and dietary intake. Then 1000 IU per day vitamin D supplement was given to the intervention group while the control group received placebo. Then crown-rump length (CRL) and femur length (FL) during the first trimester and humerus and femur lengths as well as their proximal metaphyseal diameter (PMD), midshaft diameter (MSD) and distal metaphyseal diameter (DMD) in the second and third trimester were measured using ultrasonography technique. Finally, no significant difference was observed for CRL (p = 0.93). Although FL was not statistically significant in the first trimester (p = 0.54), its measurement in the intervention group and the control group in the second (28.87 ± 2.14 vs. 26.89 ± 2.08; p ≤0.001) and the third (65.31 ± 2.17 vs. 62.85 ± 1.94; p ≤0.001) trimesters was significantly different. Femoral PMD, MSD, and DMD measurement increased more in the intervention group in comparison with the control group with P values <0.05. HL measurement in the intervention group and the control group in the second (28.62 ± 1.94 vs. 27.23 ± 2.08; p ≤0.001) and the third (61.29 ± 2.84 vs. 59.85 ± 1.79; p ≤0.001) trimesters revealed significant differences. Humeral PMD, MSD, and DMD measurement increased in the intervention group in comparison with the control group with P values <0.001 for all. It is suggested to prescribe low dose vitamin D (1000 IU per day) from early pregnancy with possible increment in length and diameter of femur and humerus bones of the fetus.",2019,"Femoral PMD, MSD, and DMD measurement increased more in the intervention group in comparison with the control group with P values <0.05.","['140 patients were divided into two equally matched groups according to age, 25(OH)D level, exercise, and dietary intake']","['vitamin D', 'vitamin D supplementation', 'placebo']","['proximal metaphyseal diameter (PMD), midshaft diameter (MSD) and distal metaphyseal diameter (DMD', 'Femoral PMD, MSD, and DMD measurement', 'crown-rump length (CRL) and femur length (FL', 'CRL', 'Humeral PMD, MSD, and DMD measurement', 'growth of fetal bones', 'HL measurement']","[{'cui': 'C4319553', 'cui_str': '140 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0332849', 'cui_str': 'Divide'}, {'cui': 'C0024908', 'cui_str': 'Matched Groups'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0015259', 'cui_str': 'Physical Activity'}, {'cui': 'C1286104', 'cui_str': 'Dietary intake'}]","[{'cui': 'C0042866', 'cui_str': 'Vitamin D'}, {'cui': 'C4524013', 'cui_str': 'Vitamin D supplementation'}, {'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C0205107', 'cui_str': 'Proximal (qualifier value)'}, {'cui': 'C1301886', 'cui_str': 'Diameter (qualifier value)'}, {'cui': 'C0205108', 'cui_str': 'Distal (qualifier value)'}, {'cui': 'C0015811', 'cui_str': 'Femur'}, {'cui': 'C0242485', 'cui_str': 'Measurement procedure'}, {'cui': 'C2825540', 'cui_str': 'Crown-Rump Length'}, {'cui': 'C1300812', 'cui_str': 'Femur length (observable entity)'}, {'cui': 'C0018270', 'cui_str': 'Growth'}, {'cui': 'C0231131', 'cui_str': 'Fetal bone structure'}]",140.0,0.0469828,"Femoral PMD, MSD, and DMD measurement increased more in the intervention group in comparison with the control group with P values <0.05.","[{'ForeName': 'Homeira', 'Initials': 'H', 'LastName': 'Vafaei', 'Affiliation': 'Maternal-Fetal Medicine Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Nasrin', 'Initials': 'N', 'LastName': 'Asadi', 'Affiliation': 'Maternal-Fetal Medicine Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Maryam', 'Initials': 'M', 'LastName': 'Kasraeian', 'Affiliation': 'Maternal-Fetal Medicine Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Hadi Raeisi', 'Initials': 'HR', 'LastName': 'Shahraki', 'Affiliation': 'Department of Epidemiology and Biostatistics, Faculty of Health, Shahrekord University of Medical Sciences, Shahrekord, Iran.'}, {'ForeName': 'Khadije', 'Initials': 'K', 'LastName': 'Bazrafshan', 'Affiliation': 'Maternal-Fetal Medicine Research Center, Shiraz University of Medical Sciences, Shiraz, Iran.'}, {'ForeName': 'Niloofar', 'Initials': 'N', 'LastName': 'Namazi', 'Affiliation': 'Resident of Obstetrics and Gynecology, Obstetrics and Gynecology Department, Shiraz University of Medical Sciences, Shiraz, Iran. Electronic address: namazin68@gmail.com.'}]",Bone,['10.1016/j.bone.2019.02.022'] 3329,31100611,The effects of transcranial direct current stimulation compared to standard bupropion for the treatment of tobacco dependence: A randomized sham-controlled trial.,"BACKGROUND Current treatments for smoking cessation are not effective for most smokers. This study aims to examine the effectiveness of transcranial Direct Current Stimulation (tDCS) on smoking cessation. METHODS In this randomized, sham-controlled trial study, tobacco-dependent (by DSM-5) male participants were recruited from the general public invitation. Participants were randomly allocated to 5 groups; (A), treatment with 300 mg bupropion for 8 weeks; (B), active tDCS (20 sessions for 4 weeks); (C), sham for group B ; (D), active tDCS (20 sessions for 12 weeks), and (E), sham for group D. The electrode montage was anode F3 and cathode F4. Study outcomes include salivary cotinine, Fagerstrom test for nicotine dependence, and smoked cigarette per day, were examined on three time points. Repeated-measures analysis of variances and the generalized estimation equation (GEE) model were employed for data analysis. RESULTS Among 210 volunteers, 170 participants completed the study. Mean age of participants was 42.9 years, ranging from 21 to 64 years. The 6-month point abstinence rates in groups A, B and D were 20%, 7% and 25.7%, and in C, D sham groups were 3.1% and 3% respectively. Results of the GEE model showed that although group D was not different from group A in abstinence rate, i.e., salivary cotinine >4 (p = 0.266), nicotine dependency by Fagerstrom test was lower in this group compared to group A (p = 0.019). CONCLUSIONS The 12-week tDCS had a clinically good therapeutic effect on smoking cessation and its dependency. It may be a substitute for bupropion treatment.",2019,"Results of the GEE model showed that although group D was not different from group A in abstinence rate, i.e., salivary cotinine >4 (p = 0.266), nicotine dependency by Fagerstrom test was lower in this group compared to group A (p = 0.019). ","['tobacco dependence', '210 volunteers, 170 participants completed the study', 'Mean age of participants was 42.9 years, ranging from 21 to 64 years', 'tobacco-dependent (by DSM-5) male participants were recruited from the general public invitation']","['bupropion', 'active tDCS', 'transcranial direct current stimulation', 'standard bupropion', 'transcranial Direct Current Stimulation (tDCS']","['smoking cessation', '6-month point abstinence rates', 'salivary cotinine, Fagerstrom test for nicotine dependence, and smoked cigarette per day', 'nicotine dependency by Fagerstrom test']","[{'cui': 'C0040332', 'cui_str': 'Tobacco Dependence'}, {'cui': 'C4319559', 'cui_str': '210'}, {'cui': 'C0042960', 'cui_str': 'Volunteer Workers'}, {'cui': 'C4517599', 'cui_str': 'One hundred and seventy'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0557651', 'cui_str': 'Study (environment)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C4517773', 'cui_str': 'Forty-two point nine'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C3542016', 'cui_str': 'Range'}, {'cui': 'C0040329', 'cui_str': 'Tobacco Products'}, {'cui': 'C0851827', 'cui_str': 'Dependent'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}]","[{'cui': 'C0085208', 'cui_str': 'Bupropion'}, {'cui': 'C0205177', 'cui_str': 'Active (qualifier value)'}, {'cui': 'C3850024', 'cui_str': 'tDCS'}, {'cui': 'C0038137', 'cui_str': 'standards'}]","[{'cui': 'C0085134', 'cui_str': 'Smokings, Giving Up'}, {'cui': 'C0439231', 'cui_str': 'month (qualifier value)'}, {'cui': 'C0442040', 'cui_str': 'Salivary (qualifier value)'}, {'cui': 'C0010194', 'cui_str': 'Scotine'}, {'cui': 'C0451156', 'cui_str': 'Fagerstrom test for nicotine dependence (assessment scale)'}, {'cui': 'C0037366', 'cui_str': 'Smoke'}, {'cui': 'C0677453', 'cui_str': 'Cigarette'}, {'cui': 'C0439505', 'cui_str': 'per day'}, {'cui': 'C0028040', 'cui_str': 'Nicotine'}, {'cui': 'C0011546', 'cui_str': 'Dependency'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}]",210.0,0.0739456,"Results of the GEE model showed that although group D was not different from group A in abstinence rate, i.e., salivary cotinine >4 (p = 0.266), nicotine dependency by Fagerstrom test was lower in this group compared to group A (p = 0.019). ","[{'ForeName': 'Shahram', 'Initials': 'S', 'LastName': 'Ghorbani Behnam', 'Affiliation': 'Student Research Committee, School of Medicine, Shahroud University of Medical Sciences, Shahroud, Iran.'}, {'ForeName': 'Seyed Abbas', 'Initials': 'SA', 'LastName': 'Mousavi', 'Affiliation': 'Center for Health Related Social and Behavioral Sciences Research, Shahroud University of Medical Sciences, Shahroud, Iran.'}, {'ForeName': 'Mohammad Hassan', 'Initials': 'MH', 'LastName': 'Emamian', 'Affiliation': 'Department of Epidemiology, School of Public Health, Shahroud University of Medical Sciences, Shahroud, Iran. Electronic address: emamian@shmu.ac.ir.'}]",European psychiatry : the journal of the Association of European Psychiatrists,['10.1016/j.eurpsy.2019.04.010'] 3330,31759891,Achieving clinically meaningful response in endometriosis pain symptoms is associated with improvements in health-related quality of life and work productivity: analysis of 2 phase III clinical trials.,"BACKGROUND Endometriosis-related pain symptoms have a negative impact on health-related quality of life and productivity. In fact, as endometriosis-related symptom severity and the number of symptoms experienced increases, health-related quality of life decreases. Dysmenorrhea and nonmenstrual pelvic pain are prominent symptoms experienced by women with endometriosis and were shown to have improved with the oral, nonpeptide gonadotropin-releasing hormone antagonist, elagolix. OBJECTIVE The objective of this post hoc analysis was to address the question of if patients show a clinical response (in dysmenorrhea or nonmenstrual pelvic pain), do they also have improvements in health-related quality of life and in productivity? STUDY DESIGN This post hoc analysis used data from the Elaris Endometriosis-I and Elaris Endometriosis-II phase III, randomized, placebo-controlled studies. A surgical diagnosis of endometriosis (in the past 10 years), premenopausal, aged 18-49 years, and moderate to severe endometriosis-associated pain were among the inclusion criteria for both trials. Women self-reported pain daily using a scale ranging from 0 (no pain) to 3 (severe pain); daily pain was assigned to either dysmenorrhea or nonmenstrual pelvic pain based on self-reported bleeding on that particular day. In addition, their self-reported endometriosis-associated pain must have been an average of moderate or severe during the month leading to baseline for inclusion in the trial program. Patients were characterized as achieving a clinical response for dysmenorrhea or nonmenstrual pelvic pain (ie, responder or nonresponder), which was defined as women who did not have an increase in analgesic use and who met the pain reduction score threshold at month 3. Pain reduction score thresholds were defined separately for dysmenorrhea and nonmenstrual pelvic pain in the trial using receiver-operating characteristics analysis. Health-related quality of life was assessed using the Endometriosis Health Profile-30; work productivity was assessed using the Health-Related Productivity Questionnaire. RESULTS Women enrolled in Elaris Endometriosis-I (n = 871) and Elaris Endometriosis-II (n = 815) were included in this analysis. Patients with a clinical response during treatment to dysmenorrhea or nonmenstrual pelvic pain also experienced a meaningful improvement in all domains of the Endometriosis Health Profile-30 at month 3. Patients who did not show a dysmenorrhea or nonmenstrual pelvic pain clinical response at month 3 did not exhibit mean improvements in Endometriosis Health Profile-30 domain scores that indicate an Endometriosis Health Profile-30 responder. Productivity improved among dysmenorrhea clinical responders. In the Elaris Endometriosis-I study, clinical responders lost a total of 5.9 hours compared with a total of 13.0 hours for nonresponders of employment-related work at month 3 (P < .0001). Among women in the Elaris Endometriosis-II study, a total of 4.1 hours and 10.4 employment-related hours were lost at month 3 for dysmenorrhea responders vs nonresponders (P < .001). Similar results were obtained when analyzed by non-enstrual pelvic pain responder status. CONCLUSION Women with moderate to severe endometriosis-related pain, who are clinical responders based on dysmenorrhea and nonmenstrual pelvic pain, also experience significant and clinically meaningful improvement in health-related quality of life and productivity as measured by the Endometriosis Health Profile-30 and Health-Related Productivity Questionnaire, respectively.",2020,Patients with a clinical response during treatment to dysmenorrhea or non-menstrual pelvic pain also experienced a meaningful improvement in all domains of the EHP-30 at month 3.,"['Women enrolled in EM-I (n=871) and EM-II (n=815', 'A surgical diagnosis of endometriosis (in the past 10 years), premenopausal, age 18-49 years, and moderate to severe endometriosis-associated pain were among the inclusion criteria for both trials', 'patients show a clinical response (in dysmenorrhea or non-menstrual pelvic pain']",['placebo'],"['EHP-30 domain scores', 'HRQoL', 'dysmenorrhea or non-menstrual pelvic pain clinical response', 'clinical response for dysmenorrhea or non-menstrual pelvic pain', 'dysmenorrhea and non-menstrual pelvic pain', 'HRQoL and productivity', 'Dysmenorrhea and non-menstrual pelvic pain', 'dysmenorrhea or non-menstrual pelvic pain', 'Productivity', 'Endometriosis Health Profile-30 (EHP-30); work productivity assessed using the Health-Related Productivity Questionnaire (HRPQ']","[{'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0047247', 'cui_str': 'ANDS'}, {'cui': 'C0543467', 'cui_str': 'Operative Procedures'}, {'cui': 'C1704338', 'cui_str': 'diagnosis'}, {'cui': 'C0014175', 'cui_str': 'Endometriosis'}, {'cui': 'C1444637', 'cui_str': 'In the past'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C1299393', 'cui_str': 'Moderate to severe'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0013390', 'cui_str': 'Pain, Menstrual'}, {'cui': 'C0030794', 'cui_str': 'Pelvic Pain'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}]","[{'cui': 'C3541951', 'cui_str': 'Domain'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C4279947', 'cui_str': 'HRQOL'}, {'cui': 'C0013390', 'cui_str': 'Pain, Menstrual'}, {'cui': 'C0030794', 'cui_str': 'Pelvic Pain'}, {'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0033269', 'cui_str': 'Productivity'}, {'cui': 'C0014175', 'cui_str': 'Endometriosis'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0445223', 'cui_str': 'Related (finding)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}]",,0.0854593,Patients with a clinical response during treatment to dysmenorrhea or non-menstrual pelvic pain also experienced a meaningful improvement in all domains of the EHP-30 at month 3.,"[{'ForeName': 'Robin M', 'Initials': 'RM', 'LastName': 'Pokrzywinski', 'Affiliation': 'Patient-Centered Research, Evidera, Bethesda, MD. Electronic address: robin.pokrzywinski@evidera.com.'}, {'ForeName': 'Ahmed M', 'Initials': 'AM', 'LastName': 'Soliman', 'Affiliation': 'AbbVie, Inc, North Chicago, IL.'}, {'ForeName': 'Jun', 'Initials': 'J', 'LastName': 'Chen', 'Affiliation': 'Patient-Centered Research, Evidera, Bethesda, MD.'}, {'ForeName': 'Michael C', 'Initials': 'MC', 'LastName': 'Snabes', 'Affiliation': 'AbbVie, Inc, North Chicago, IL.'}, {'ForeName': 'Karin S', 'Initials': 'KS', 'LastName': 'Coyne', 'Affiliation': 'Patient-Centered Research, Evidera, Bethesda, MD.'}, {'ForeName': 'Eric S', 'Initials': 'ES', 'LastName': 'Surrey', 'Affiliation': 'Colorado Center for Reproductive Medicine, Lone Tree, CO.'}, {'ForeName': 'Hugh S', 'Initials': 'HS', 'LastName': 'Taylor', 'Affiliation': 'Yale School of Medicine, New Haven, CT.'}]",American journal of obstetrics and gynecology,['10.1016/j.ajog.2019.11.1255'] 3331,31199513,Switching from entecavir to tenofovir alafenamide versus maintaining entecavir for chronic hepatitis B.,"Tenofovir alafenamide (TAF) is a newly developed prodrug of tenofovir (TFV). We divided 48 chronic hepatitis B patients who had taken entecavir (ETV) for ≥2 years into two groups: the ETV continuation (n = 24) and the TAF switching (n = 24) groups, and compared the antiviral effects and safety until 48 weeks after the start of the study. There were no significant differences in the alterations in the serum levels of HBs antigen (HBsAg) level between the ETV continuation and the TAF switching groups at 24 or 48 weeks. We also examined the effect of baseline HBsAg level on the decrease of HBsAg during the treatment; in the TAF switching group, the decrease of HBsAg level at 48 weeks was more significant in patients with low baseline HBsAg (<800 IU/mL) than those with high baseline HBsAg ( >800 IU/mL) (change of HBsAg; - 0.029 vs - 0.132 for high and low baseline HBsAg, respectively, P = .007). Also, the effect on renal function was found to be comparable between the TAF switch group and the ETV continuation group. In this study, switching from ETV to TAF may represent higher efficacy for a decrease of HBsAg than a continuation of ETV among the patients with low baseline HBsAg level.",2019,There were no significant differences in the alterations in the serum levels of HBs antigen (HBsAg) level between the ETV continuation and the TAF switching groups at 24 or 48 weeks.,"['48 chronic hepatitis B patients who had taken entecavir (ETV) for ≥2 years into two groups: the ETV continuation (n\u2009=\u200924) and the', 'chronic hepatitis B']","['TAF switching', 'tenofovir alafenamide', 'tenofovir (TFV', 'Tenofovir alafenamide (TAF']","['serum levels of HBs antigen (HBsAg) level', 'renal function', 'HBsAg level']","[{'cui': 'C0524909', 'cui_str': 'Chronic Hepatitis B Virus Infection'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C0971023', 'cui_str': 'entecavir'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0439745', 'cui_str': 'Grouped (qualifier value)'}]","[{'cui': 'C3713958', 'cui_str': 'tenofovir alafenamide'}, {'cui': 'C0384228', 'cui_str': 'Tenofovir'}]","[{'cui': 'C0229671', 'cui_str': 'Serum'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}, {'cui': 'C0019043', 'cui_str': 'Hemoglobin S'}, {'cui': 'C0430420', 'cui_str': 'Antigen level'}, {'cui': 'C0232804', 'cui_str': 'Renal function (observable entity)'}, {'cui': 'C0201477', 'cui_str': 'Hepatitis B surface antigen measurement (procedure)'}]",48.0,0.0514185,There were no significant differences in the alterations in the serum levels of HBs antigen (HBsAg) level between the ETV continuation and the TAF switching groups at 24 or 48 weeks.,"[{'ForeName': 'Satoru', 'Initials': 'S', 'LastName': 'Hagiwara', 'Affiliation': 'Department of Gastroenterology and Hepatology, Faculty of Medicine, Kindai University, Osakasayama, Japan.'}, {'ForeName': 'Naoshi', 'Initials': 'N', 'LastName': 'Nishida', 'Affiliation': 'Department of Gastroenterology and Hepatology, Faculty of Medicine, Kindai University, Osakasayama, Japan.'}, {'ForeName': 'Hiroshi', 'Initials': 'H', 'LastName': 'Ida', 'Affiliation': 'Department of Gastroenterology and Hepatology, Faculty of Medicine, Kindai University, Osakasayama, Japan.'}, {'ForeName': 'Kazuomi', 'Initials': 'K', 'LastName': 'Ueshima', 'Affiliation': 'Department of Gastroenterology and Hepatology, Faculty of Medicine, Kindai University, Osakasayama, Japan.'}, {'ForeName': 'Yasunori', 'Initials': 'Y', 'LastName': 'Minami', 'Affiliation': 'Department of Gastroenterology and Hepatology, Faculty of Medicine, Kindai University, Osakasayama, Japan.'}, {'ForeName': 'Masahiro', 'Initials': 'M', 'LastName': 'Takita', 'Affiliation': 'Department of Gastroenterology and Hepatology, Faculty of Medicine, Kindai University, Osakasayama, Japan.'}, {'ForeName': 'Yoriaki', 'Initials': 'Y', 'LastName': 'Komeda', 'Affiliation': 'Department of Gastroenterology and Hepatology, Faculty of Medicine, Kindai University, Osakasayama, Japan.'}, {'ForeName': 'Masatoshi', 'Initials': 'M', 'LastName': 'Kudo', 'Affiliation': 'Department of Gastroenterology and Hepatology, Faculty of Medicine, Kindai University, Osakasayama, Japan.'}]",Journal of medical virology,['10.1002/jmv.25515'] 3332,31222915,"Supervised teaching and feedback improve physiotherapists' reporting of the International Classification of Functioning, Disability and Health in physiotherapeutic electronic patient records: A proof-of-concept randomized controlled trial.","RATIONALE, AIMS, AND OBJECTIVES The International Classification of Functioning, Disability and Health (ICF) is a landmark for physiotherapy to describe the full spectrum of human functioning, but ICF patient record completion could improve. In this study, we examine the effect of supervised teaching and personalized feedback on physiotherapists' completion and reporting of ICF in electronic patient records. METHOD In this proof-of-concept randomized controlled trial, the intervention group (10 physiotherapists) received supervised teaching and four rounds of personalized feedback on reporting of ICF components in electronic patient records. In the intervention group, review on patient record completion (n = 670 records) was performed at baseline, after teaching, after each of four feedback rounds, and at long-term follow-up. In the control group (five physiotherapists), which received no supervised teaching nor personalized feedback, review (n = 140 records) was performed at baseline, after the third feedback round of the intervention group, and at follow-up. RESULTS After the third round of feedback (95% vs 72% completion; β, 2.68; 95% CI, 0.62-4.74), patient record completion was significantly higher in the intervention group. This was also true for following ICF components: ""activity"" (93% versus 64% completion; β, 3.03; 95% CI, 1.52-4.54), ""participation"" (50% versus 14% completion; β, 3.67; 95% CI, 1.79-5.55), and ""personal factors"" (35% versus 20% completion; β, 2.10; 95% CI, 0.63-3.57). These statistically significant and clinically relevant effects persisted at long-term follow-up. For ""environmental factors,"" effects after the third round of feedback (75% vs 30% completion; β, 1.88; 95% CI, 0.63-3.13) disappeared at follow-up. Reporting of ""body functions and structures"" improved similarly across groups. CONCLUSIONS Supervised teaching and personalized feedback are active ingredients of an intervention to improve reporting of ICF components in physiotherapeutic patient records.",2020,"After the third round of feedback (95% vs 72% completion; β, 2.68; 95% CI, 0.62-4.74), patient record completion was significantly higher in the intervention group.",[],"['supervised teaching and personalized feedback', 'Supervised teaching and feedback', 'supervised teaching and four rounds of personalized feedback']","['participation', 'patient record completion', 'personal factors']",[],"[{'cui': 'C0039401', 'cui_str': 'Teaching'}, {'cui': 'C0015744', 'cui_str': 'Feedback'}]","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0034869', 'cui_str': 'Records as Topic'}]",670.0,0.257474,"After the third round of feedback (95% vs 72% completion; β, 2.68; 95% CI, 0.62-4.74), patient record completion was significantly higher in the intervention group.","[{'ForeName': 'Liesbeth', 'Initials': 'L', 'LastName': 'Lamsens', 'Affiliation': 'Department of Physical and Rehabilitation Medicine, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'Lotte', 'Initials': 'L', 'LastName': 'Janssens', 'Affiliation': 'Musculoskeletal Research Group, Department of Rehabilitation Sciences, KU Leuven-University of Leuven, Leuven, Belgium.'}, {'ForeName': 'Koenraad', 'Initials': 'K', 'LastName': 'Peers', 'Affiliation': 'Department of Physical and Rehabilitation Medicine, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'Kim', 'Initials': 'K', 'LastName': 'Caluwé', 'Affiliation': 'Department of Physical and Rehabilitation Medicine, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'Carlotte', 'Initials': 'C', 'LastName': 'Kiekens', 'Affiliation': 'Department of Physical and Rehabilitation Medicine, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'Johan', 'Initials': 'J', 'LastName': 'Van Eldere', 'Affiliation': 'Department of Quality Management, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'Kris', 'Initials': 'K', 'LastName': 'Vanhaecht', 'Affiliation': 'Department of Quality Management, University Hospitals Leuven, Leuven, Belgium.'}, {'ForeName': 'Luk', 'Initials': 'L', 'LastName': 'Bruyneel', 'Affiliation': 'Department of Quality Management, University Hospitals Leuven, Leuven, Belgium.'}]",Journal of evaluation in clinical practice,['10.1111/jep.13212'] 3333,31081480,Do race/ethnicity and religious affiliation moderate treatment outcomes among individuals with co-occurring PTSD and substance use disorders?,"The effect of race/ethnicity and religious affiliation on treatment outcomes among 107 individuals with co-occurring substance use disorder (SUD) and full or subthreshold posttraumatic stress disorder (PTSD) was examined in a secondary analysis. Participants were randomly assigned to one of three treatment conditions: dual-disorder treatment of PTSD and SUD using prolonged exposure; single-disorder relapse prevention treatment for SUD; or an active monitoring control group. Results revealed no significant interaction between race/ethnicity and treatment on PTSD and substance use frequency. However, compared to Whites, African Americans had significantly lower levels of PTSD over the course of treatment. Religious affiliation moderated the impact of treatment on substance use frequency and was a significant predictor of PTSD scores during treatment. Results highlight the need to explore factors associated with social identity variables such as race and religion that may enhance or attenuate the mechanisms of treatments for PTSD and SUD.",2019,Religious affiliation moderated the impact of treatment on substance use frequency and was a significant predictor of PTSD scores during treatment.,"['107 individuals with co-occurring substance use disorder (SUD) and full or subthreshold posttraumatic stress disorder (PTSD', 'individuals with co-occurring PTSD and substance use disorders']",['dual-disorder treatment of PTSD and SUD using prolonged exposure; single-disorder relapse prevention treatment for SUD; or an active monitoring control group'],"['PTSD scores', 'levels of PTSD']","[{'cui': 'C4517529', 'cui_str': 'One hundred and seven'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0038586', 'cui_str': 'Substance Use Disorders'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}]","[{'cui': 'C0012634', 'cui_str': 'Disease'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0439590', 'cui_str': 'Prolonged (qualifier value)'}, {'cui': 'C0274281', 'cui_str': 'Injury due to exposure to external cause (disorder)'}, {'cui': 'C0205171', 'cui_str': 'Singular (qualifier value)'}, {'cui': 'C0679867', 'cui_str': 'Relapse Prevention'}, {'cui': 'C1531698', 'cui_str': 'Active monitoring'}, {'cui': 'C0009932', 'cui_str': 'Control Groups'}]","[{'cui': 'C0038436', 'cui_str': 'Neuroses, Posttraumatic'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",107.0,0.0141669,Religious affiliation moderated the impact of treatment on substance use frequency and was a significant predictor of PTSD scores during treatment.,"[{'ForeName': 'Lesia M', 'Initials': 'LM', 'LastName': 'Ruglass', 'Affiliation': 'a Department of Psychology , The City College of New York , New York , USA.'}, {'ForeName': 'Ann M', 'Initials': 'AM', 'LastName': 'Yali', 'Affiliation': 'a Department of Psychology , The City College of New York , New York , USA.'}]",Journal of prevention & intervention in the community,['10.1080/10852352.2019.1603674'] 3334,31234234,Cost-benefit analysis of clinical pharmacist intervention in preventing adverse drug events in the general chronic diseases outpatients.,"RATIONALE, AIMS, AND OBJECTIVES Clinical pharmacy services are vital in the prevention of adverse drug events (ADEs) in clinical practice, extending beyond the hospital to chronic disease management in outpatient settings. This study sought to evaluate the cost benefit of a clinical pharmacy intervention in resolving treatment-related problems (TRPs) among hospital outpatients with chronic diseases. METHODS From the hospital system perspective, the cost-benefit analysis was based on a randomized clinical trial in the general outpatients of the major hospital in Jordan. Eligible patients were randomly assigned to either an intervention or a control group. TRPs were identified in both study groups, but interventions were delivered only to the intervention group via a home medication management review (HMMR) by a clinical pharmacist. A follow-up in both groups took place 3 months after recruitment. The total economic benefit was the sum of (a) cost savings due to intervention and (b) cost avoidance associated with preventable ADEs. The primary outcome measures were the net benefit and benefit-to-cost ratio with the clinical pharmacist-based HMMR. RESULTS In both groups, 158 TRPs were identified, and 79 interventions were provided in the study group. The monthly cost of intervention was JD764 (US $1078), and the total monthly benefit was JD4570 (US $6444), leading to a benefit-to-cost ratio of 5.98 and an annual net benefit of JD45 669 (US $64 393). Sensitivity analyses confirmed the robustness of results. CONCLUSION The RCT-based cost-benefit evaluation provided evidence-based insight into the economic benefit of a clinical pharmacist-provided HMMR for preventing ADEs in the general chronic diseases outpatients. This intervention method against the TRPs among outpatients is cost beneficial and offers substantial cost savings to the health care hospital payer in Jordan.",2020,This intervention method against the TRPs among outpatients is cost beneficial and offers substantial cost savings to the health care hospital payer in Jordan.,"['hospital outpatients with chronic diseases', 'From the hospital system perspective', 'general outpatients of the major hospital in Jordan', 'general chronic diseases outpatients', 'Eligible patients']","['clinical pharmacy intervention', 'clinical pharmacist intervention']","['total economic benefit', 'adverse drug events', 'net benefit and benefit-to-cost ratio with the clinical pharmacist-based HMMR']","[{'cui': 'C1510665', 'cui_str': 'Hospital environment (environment)'}, {'cui': 'C0029921', 'cui_str': 'Out-patients'}, {'cui': 'C0008679', 'cui_str': 'Chronic Illness'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C0205246', 'cui_str': 'Generalized (qualifier value)'}, {'cui': 'C0205082', 'cui_str': 'Severe (severity modifier) (qualifier value)'}, {'cui': 'C0022418', 'cui_str': 'Jordan'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0205210', 'cui_str': 'Clinical (qualifier value)'}, {'cui': 'C0031322', 'cui_str': 'Pharmacies'}, {'cui': 'C1449564', 'cui_str': 'Clinical Pharmacists'}]","[{'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0013557', 'cui_str': 'economics'}, {'cui': 'C0041755', 'cui_str': 'Drug Side Effects'}, {'cui': 'C0010186', 'cui_str': 'Cost'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C1449564', 'cui_str': 'Clinical Pharmacists'}, {'cui': 'C0178499', 'cui_str': 'Base'}]",,0.0398675,This intervention method against the TRPs among outpatients is cost beneficial and offers substantial cost savings to the health care hospital payer in Jordan.,"[{'ForeName': 'Rajaa A', 'Initials': 'RA', 'LastName': 'Al-Qudah', 'Affiliation': 'Department of Clinical Pharmacy and Therapeutics, Faculty of Pharmacy, Applied Science Private University, Amman, Jordan.'}, {'ForeName': 'Daoud', 'Initials': 'D', 'LastName': 'Al-Badriyeh', 'Affiliation': 'College of Pharmacy, QU Health Cluster, Qatar University, Doha, Qatar.'}, {'ForeName': 'Farah M', 'Initials': 'FM', 'LastName': 'Al-Ali', 'Affiliation': 'Department of Clinical Pharmacy and Therapeutics, Faculty of Pharmacy, Applied Science Private University, Amman, Jordan.'}, {'ForeName': 'Shoroq M', 'Initials': 'SM', 'LastName': 'Altawalbeh', 'Affiliation': 'Department of Clinical Pharmacy, Faculty of Pharmacy, Jordan University of Science and Technology, Irbid, Jordan.'}, {'ForeName': 'Iman A', 'Initials': 'IA', 'LastName': 'Basheti', 'Affiliation': 'Department of Clinical Pharmacy and Therapeutics, Faculty of Pharmacy, Applied Science Private University, Amman, Jordan.'}]",Journal of evaluation in clinical practice,['10.1111/jep.13209'] 3335,30894365,Mediation of the Effect of Glycemia on the Risk of CVD Outcomes in Type 1 Diabetes: The DCCT/EDIC Study.,"OBJECTIVE The Diabetes Control and Complications Trial (DCCT)/Epidemiology of Diabetes Interventions and Complications (EDIC) study has demonstrated the major role of hyperglycemia as a risk factor for clinical cardiovascular outcomes in type 1 diabetes (T1D). We assessed whether and to what extent the effect of glycemia is mediated by other established cardiovascular disease (CVD) risk factors. RESEARCH DESIGN AND METHODS In the DCCT, 1,441 participants were randomized to receive either intensive or conventional diabetes therapy. The EDIC observational follow-up study enrolled 96% of the surviving DCCT cohort with 94% of the survivors still actively participating after more than 27 years of follow-up. Mediation of the effect of glycemia, as captured by HbA 1c , on the subsequent CVD risk was quantified using the relative change in the CVD risk associated with HbA 1c between models without and with the potential mediator. RESULTS Adjusted for age, only a few factors (e.g., pulse, triglycerides, albumin excretion rate) explained more than 10% of the effect of glycemia on CVD risk when considered individually. In multivariable models, these traditional risk factors together mediated up to ∼50% of the effect of glycemia on the risk of CVD. However, the association between HbA 1c and the risk of CVD remained highly significant even after adjustment for these risk factors. CONCLUSIONS While HbA 1c is associated with many traditional CVD risk factors, its association with these factors alone cannot explain its effects on risk of CVD. Consequently, aggressive management of traditional nonglycemic CVD risk factors, coupled with aggressive glycemic management, is indicated for individuals with type 1 diabetes.",2019,"However, the association between HbA 1c and the risk of CVD remained highly significant even after adjustment for these risk factors. ","['individuals with type 1 diabetes', 'type 1 diabetes (T1D', 'Type 1 Diabetes', 'The EDIC observational follow-up study enrolled 96% of the surviving DCCT cohort with 94% of the survivors still actively participating after more than 27 years of follow-up', '1,441 participants']","['intensive or conventional diabetes therapy', 'Glycemia']",[],"[{'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0332307', 'cui_str': 'Type - attribute'}, {'cui': 'C0441729', 'cui_str': 'Type 1 (qualifier value)'}, {'cui': 'C0016441', 'cui_str': 'Followup Studies'}, {'cui': 'C0206194', 'cui_str': 'Survivors'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0589120', 'cui_str': 'Follow-up'}]","[{'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]",[],1441.0,0.040217,"However, the association between HbA 1c and the risk of CVD remained highly significant even after adjustment for these risk factors. ","[{'ForeName': 'Ionut', 'Initials': 'I', 'LastName': 'Bebu', 'Affiliation': 'Biostatistics Center, The George Washington University, Rockville, MD ibebu@bsc.gwu.edu.'}, {'ForeName': 'Barbara H', 'Initials': 'BH', 'LastName': 'Braffett', 'Affiliation': 'Biostatistics Center, The George Washington University, Rockville, MD.'}, {'ForeName': 'Trevor J', 'Initials': 'TJ', 'LastName': 'Orchard', 'Affiliation': 'University of Pittsburgh, Pittsburgh, PA.'}, {'ForeName': 'Gayle M', 'Initials': 'GM', 'LastName': 'Lorenzi', 'Affiliation': 'University of California, San Diego, San Diego, CA.'}, {'ForeName': 'John M', 'Initials': 'JM', 'LastName': 'Lachin', 'Affiliation': 'Biostatistics Center, The George Washington University, Rockville, MD.'}, {'ForeName': '', 'Initials': '', 'LastName': '', 'Affiliation': ''}]",Diabetes care,['10.2337/dc18-1613'] 3336,31316254,Screw versus helical proximal femoral nail in the treatment of unstable trochanteric fractures in the elderly.,"Purpose Comparison of clinical, radiological and functional outcomes of screw proximal femoral nail (PFN) and helical PFN in management of unstable trochanteric fractures. Methods This prospective randomised comparative study included 60 patients with closed unstable intertrochanteric fractures (AO classification-A2.2-A2.3 & A3.1-A3.3). Patients were randomised to 2 treatment groups using simple random sampling method utilizing computer based randomisation. Screw PFN and helical PFN were used for internal fixation with 30 patients in each group. Results Both groups were similar in respect of age, gender, fracture classification, quality of fracture reduction, duration of hospitalization, post-operative complications, residual/late deformity as well as functional assessment. However, mean duration of surgery was significantly lower (23.1%) in helical PFN group as compared to screw PFN group (43.32 ± 8.20 min vs. 35.20 ± 6.03 min, p < 0.001). Furthermore, mean blood loss was not significant in either of the study groups but it was significantly lesser (30.1%) in helical PFN group as compared to screw PFN group (77.80 ± 17.39 ml vs. 59.80 ± 14.96 ml, p < 0.001). Also, mean number of images taken was significantly lower (58.7%) in helical PFN group as compared to screw PFN group (29.52 ± 4.85 no vs. 18.60 ± 3.12 no, t = 9.47; p < 0.001). Conclusion Both screw PFN and helical PFN are equally effective implants in internal fixation of unstable trochanteric fractures with no statistically significant difference (p > 0.05) in any of the outcome measures. However, helical PFN group fared marginally better in terms of operative time, blood loss and imaging required.",2019,"Furthermore, mean blood loss was not significant in either of the study groups","['unstable trochanteric fractures in the elderly', '60 patients with closed unstable intertrochanteric fractures (AO classification-A2.2-A2.3 & A3.1-A3.3']","['Screw PFN and helical PFN', 'screw PFN', 'screw proximal femoral nail (PFN) and helical PFN', 'Screw versus helical proximal femoral nail']","['mean blood loss', 'operative time, blood loss and imaging required', 'mean number of images taken', 'mean duration of surgery']","[{'cui': 'C0443343', 'cui_str': 'Unstable status (qualifier value)'}, {'cui': 'C0162387', 'cui_str': 'Trochanteric Fractures'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0162385', 'cui_str': 'Intertrochanteric Fractures'}, {'cui': 'C0008903', 'cui_str': 'taxonomy'}]","[{'cui': 'C0301559', 'cui_str': 'Screw (physical object)'}, {'cui': 'C0205107', 'cui_str': 'Proximal (qualifier value)'}, {'cui': 'C0015811', 'cui_str': 'Femur'}, {'cui': 'C0027342', 'cui_str': 'Nails'}]","[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0019080', 'cui_str': 'Bleeding'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C3542466', 'cui_str': 'Image (foundation metadata concept)'}, {'cui': 'C1515187', 'cui_str': 'Take'}, {'cui': 'C2926735', 'cui_str': 'Duration'}, {'cui': 'C1274039', 'cui_str': 'Surgery'}]",60.0,0.0216532,"Furthermore, mean blood loss was not significant in either of the study groups","[{'ForeName': 'Col Narinder', 'Initials': 'CN', 'LastName': 'Kumar', 'Affiliation': 'Department of Orthopaedics, Military Hospital, Kirkee, Pune, Maharastra, 411020, India.'}, {'ForeName': 'Maj P K', 'Initials': 'MPK', 'LastName': 'Srivastava', 'Affiliation': 'Department of Orthopaedics, 158 Base Hospital, c/o 99 A.P.O., India.'}]",Journal of clinical orthopaedics and trauma,['10.1016/j.jcot.2018.07.012'] 3337,31838405,Patient-reported outcomes from FLAURA: Osimertinib versus erlotinib or gefitinib in patients with EGFR-mutated advanced non-small-cell lung cancer.,"BACKGROUND In the FLAURA trial, osimertinib demonstrated superior progression-free survival and a favorable toxicity profile to erlotinib or gefitinib as initial therapy in patients with EGFR-mutated advanced non-small-cell lung cancer. Patient-reported outcomes from FLAURA are discussed here. METHODS Patients (N = 556) completed the EORTC QLQ-LC13 weekly for 6 weeks, then every 3 weeks, and the QLQ-C30 every 6 weeks. Prespecified key symptoms were cough, dyspnea, chest pain, appetite loss, and fatigue. Score changes from baseline to randomized treatment discontinuation were assessed using a mixed-effects model. A ≥10-point change was considered clinically relevant. Odds of improvement and time to deterioration were investigated. QLQ-C30 functioning scores were assessed post hoc. RESULTS Questionnaire completion rates were >70% at most time points. Baseline mean scores were similar in the osimertinib and erlotinib/gefitinib arms. Scores improved in both arms, but none reached clinical relevance at 5% significance level. A statistically significant difference favoring osimertinib for chest pain was not clinically relevant (-6.84 vs -3.88; p = 0.021). Odds of improvement and time to deterioration were similar between treatments. In post hoc analyses, improvements favored osimertinib for emotional functioning (8.79 vs 4.91; p = 0.004) and social functioning (7.66 vs 1.74; p < 0.001). Cognitive functioning remained stable with osimertinib but deteriorated with erlotinib/gefitinib (0.03 vs -3.91; p = 0.005). CONCLUSIONS Key symptoms improved from baseline in both treatment arms in FLAURA. Key symptom improvements that were both statistically significant and clinically relevant were not observed in favor of either treatment arm. CLINICAL TRIAL REGISTRATION NCT02296125.",2020,"In post hoc analyses, improvements favored osimertinib for emotional functioning (8.79 vs 4.91; p = 0.004) and social functioning (7.66 vs 1.74; p < 0.001).","['Patients (N\xa0=\xa0556) completed the', 'patients with EGFR-mutated advanced non-small-cell lung cancer']","['FLAURA', 'EORTC QLQ-LC13', 'Osimertinib versus erlotinib or gefitinib', 'erlotinib/gefitinib', 'erlotinib or gefitinib']","['osimertinib for emotional functioning', 'Questionnaire completion rates', 'Cognitive functioning', 'chest pain', 'Baseline mean scores', 'cough, dyspnea, chest pain, appetite loss, and fatigue', 'social functioning', 'time to deterioration', 'QLQ-C30 functioning scores']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C4517811', 'cui_str': 'Five hundred and fifty-six'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0007131', 'cui_str': 'Nonsmall Cell Lung Cancer'}]","[{'cui': 'C4058811', 'cui_str': 'osimertinib'}, {'cui': 'C1135135', 'cui_str': 'erlotinib'}, {'cui': 'C1122962', 'cui_str': 'gefitinib'}]","[{'cui': 'C4058811', 'cui_str': 'osimertinib'}, {'cui': 'C0849912', 'cui_str': 'Emotional (qualifier value)'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0008031', 'cui_str': 'Chest Pain'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0449820', 'cui_str': 'Scores (qualifier value)'}, {'cui': 'C0010200', 'cui_str': 'Complaining of cough (finding)'}, {'cui': 'C0013404', 'cui_str': 'Breathlessness'}, {'cui': 'C0003618', 'cui_str': 'Appetite'}, {'cui': 'C0015672', 'cui_str': 'Fatigue'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0031843', 'cui_str': 'function'}]",556.0,0.200839,"In post hoc analyses, improvements favored osimertinib for emotional functioning (8.79 vs 4.91; p = 0.004) and social functioning (7.66 vs 1.74; p < 0.001).","[{'ForeName': 'Natasha B', 'Initials': 'NB', 'LastName': 'Leighl', 'Affiliation': 'Princess Margaret Cancer Centre, Toronto, ON, Canada.'}, {'ForeName': 'Nina', 'Initials': 'N', 'LastName': 'Karaseva', 'Affiliation': 'City Clinical Oncology Dispensary, St. Petersburg, Russia.'}, {'ForeName': 'Kazuhiko', 'Initials': 'K', 'LastName': 'Nakagawa', 'Affiliation': 'Department of Medical Oncology, Kindai University Faculty of Medicine, Osakasayama, Japan.'}, {'ForeName': 'Byoung-Chul', 'Initials': 'BC', 'LastName': 'Cho', 'Affiliation': 'Division of Medical Oncology, Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, Republic of Korea.'}, {'ForeName': 'Jhanelle E', 'Initials': 'JE', 'LastName': 'Gray', 'Affiliation': 'Department of Thoracic Oncology, H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL, USA.'}, {'ForeName': 'Tina', 'Initials': 'T', 'LastName': 'Hovey', 'Affiliation': 'PHASTAR, London, UK.'}, {'ForeName': 'Andrew', 'Initials': 'A', 'LastName': 'Walding', 'Affiliation': 'AstraZeneca R&D, Cambridge, UK.'}, {'ForeName': 'Anna', 'Initials': 'A', 'LastName': 'Rydén', 'Affiliation': 'AstraZeneca Gothenburg, Mölndal, Sweden.'}, {'ForeName': 'Silvia', 'Initials': 'S', 'LastName': 'Novello', 'Affiliation': 'Department of Oncology, University of Turin, Azienda Ospedaliero-Universitaria San Luigi Gonzaga, Turin, Italy. Electronic address: silvia.novello@unito.it.'}]","European journal of cancer (Oxford, England : 1990)",['10.1016/j.ejca.2019.11.006'] 3338,31283830,Mindfulness-Based Stress Reduction Versus a Health Enhancement Program in the Treatment of Urge Urinary Incontinence in Older Adult Women: A Randomized Controlled Feasibility Study.,"Current treatment practices for older adult women with urge urinary incontinence (UUI) remain insufficient and ineffective. A randomized controlled feasibility trial was developed to evaluate three determinants of research feasibility and three determinants of intervention feasibility when comparing mindfulness-based stress reduction (MBSR) with a health enhancement program (HEP) in older adult women with UUI. Participants were recruited from the university health system, county senior centers, and community sites. Twenty-five postmenopausal women (mean age = 74 years) were randomized into MBSR treatment conditions or HEP comparison conditions for an 8-week intervention. Participants remained blinded to conditions. Research feasibility determinants were measured as recruitment, retention, and treatment delivery; intervention feasibility determinants were measured as acceptability, tolerability, and client receipt/enactment. Feasibility determinants established in the research literature as essential to intervention evaluation were recorded and evaluated throughout the current study. All six feasibility determinants confirmed positive results in the enrolled population. The use of MBSR and HEP as the active comparison to treat UUI in older adult women proved feasible in this trial. The results warrant the design of a larger-scale, multisite trial to study the efficacy of MBSR in treating UUI in older adult women. TARGETS Older adult women with high incidence of UUI. INTERVENTION DESCRIPTION MBSR treatment conditions or HEP comparison conditions. MECHANISMS OF ACTION Research and intervention feasibility determinants. OUTCOMES The use of MBSR and HEP as the active comparison to treat UUI in older adult women proved feasible in this trial. [ Research in Gerontological Nursing, 12(6), 285-297.].",2019,Twenty-five postmenopausal women (mean age = 74 years) were randomized into MBSR treatment conditions or HEP comparison conditions for an 8-week intervention.,"['Participants were recruited from the university health system, county senior centers, and community sites', 'older adult women with urge urinary incontinence (UUI', 'Older Adult Women', 'Older adult women with high incidence of UUI', 'Twenty-five postmenopausal women (mean age = 74 years', 'older adult women', 'older adult women with UUI']","['MBSR', 'mindfulness-based stress reduction (MBSR) with a health enhancement program (HEP', 'MBSR and HEP', 'MBSR treatment conditions or HEP', 'Mindfulness-Based Stress Reduction Versus a Health Enhancement Program']","['acceptability, tolerability, and client receipt/enactment']","[{'cui': 'C0041740', 'cui_str': 'Universities'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C0449913', 'cui_str': 'System (attribute)'}, {'cui': 'C3658240', 'cui_str': 'Centers for the Aged'}, {'cui': 'C0009462', 'cui_str': 'Community'}, {'cui': 'C0205145', 'cui_str': 'Site (attribute)'}, {'cui': 'C0677546', 'cui_str': 'Old episode (qualifier value)'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C0150045', 'cui_str': 'Urinary Reflex Incontinence'}, {'cui': 'C0205250', 'cui_str': 'High (qualifier value)'}, {'cui': 'C0220856', 'cui_str': 'incidence'}, {'cui': 'C3715062', 'cui_str': '25'}, {'cui': 'C0232970', 'cui_str': 'Postmenopausal state (finding)'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}]","[{'cui': 'C3542996', 'cui_str': 'Mindfulness'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0038435', 'cui_str': 'Stress - value'}, {'cui': 'C4551656', 'cui_str': 'Surgical reduction'}, {'cui': 'C0018684', 'cui_str': 'Health'}, {'cui': 'C1627358', 'cui_str': 'Refractive surgery enhancement'}, {'cui': 'C2728259', 'cui_str': 'Program'}, {'cui': 'C0449198', 'cui_str': 'HEP (body structure)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0348080', 'cui_str': 'Condition (attribute)'}]","[{'cui': 'C3645535', 'cui_str': 'Acceptability'}, {'cui': 'C0008942', 'cui_str': 'Clients'}]",25.0,0.0513843,Twenty-five postmenopausal women (mean age = 74 years) were randomized into MBSR treatment conditions or HEP comparison conditions for an 8-week intervention.,"[{'ForeName': 'Katarina Friberg', 'Initials': 'KF', 'LastName': 'Felsted', 'Affiliation': ''}, {'ForeName': 'Katherine P', 'Initials': 'KP', 'LastName': 'Supiano', 'Affiliation': ''}]",Research in gerontological nursing,['10.3928/19404921-20190702-02'] 3339,31738173,Use of a Fully Automated Internet-Based Cognitive Behavior Therapy Intervention in a Community Population of Adults With Depression Symptoms: Randomized Controlled Trial.,"BACKGROUND Although internet-based cognitive behavior therapy (iCBT) interventions can reduce depression symptoms, large differences in their effectiveness exist. OBJECTIVE The aim of this study was to evaluate the effectiveness of an iCBT intervention called Thrive, which was designed to enhance engagement when delivered as a fully automated, stand-alone intervention to a rural community population of adults with depression symptoms. METHODS Using no diagnostic or treatment exclusions, 343 adults with depression symptoms were recruited from communities using an open-access website and randomized 1:1 to the Thrive intervention group or the control group. Using self-reports, participants were evaluated at baseline and 4 and 8 weeks for the primary outcome of depression symptom severity and secondary outcome measures of anxiety symptoms, work and social adjustment, psychological resilience, and suicidal ideation. RESULTS Over the 8-week follow-up period, the intervention group (n=181) had significantly lower depression symptom severity than the control group (n=162; P<.001), with a moderate treatment effect size (d=0.63). Moderate to near-moderate effect sizes favoring the intervention group were observed for anxiety symptoms (P<.001; d=0.47), work/social functioning (P<.001; d=0.39), and resilience (P<.001; d=0.55). Although not significant, the intervention group was 45% less likely than the control group to experience increased suicidal ideation (odds ratio 0.55). CONCLUSIONS These findings suggest that the Thrive intervention was effective in reducing depression and anxiety symptom severity and improving functioning and resilience among a mostly rural community population of US adults. The effect sizes associated with Thrive were generally larger than those of other iCBT interventions delivered as a fully automated, stand-alone intervention. TRIAL REGISTRATION ClinicalTrials.gov NCT03244878; https://clinicaltrials.gov/ct2/show/NCT03244878.",2019,"Moderate to near-moderate effect sizes favoring the intervention group were observed for anxiety symptoms (P<.001; d=0.47), work/social functioning (P<.001; d=0.39), and resilience (P<.001; d=0.55).","['rural community population of adults with depression symptoms', '343 adults with depression symptoms', 'Adults With Depression Symptoms']","['Fully Automated Internet-Based Cognitive Behavior Therapy Intervention', 'iCBT intervention', 'internet-based cognitive behavior therapy (iCBT) interventions']","['anxiety symptoms', 'depression symptom severity and secondary outcome measures of anxiety symptoms, work and social adjustment, psychological resilience, and suicidal ideation', 'depression and anxiety symptom severity', 'suicidal ideation', 'work/social functioning', 'depression symptom severity']","[{'cui': 'C0086944', 'cui_str': 'Rural Communities'}, {'cui': 'C0032659', 'cui_str': 'Population'}, {'cui': 'C0001675', 'cui_str': 'Adult'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C0683368', 'cui_str': 'symptoms'}]","[{'cui': 'C0205554', 'cui_str': 'Automated (qualifier value)'}, {'cui': 'C0282111', 'cui_str': 'World Wide Web'}, {'cui': 'C0178499', 'cui_str': 'Base'}, {'cui': 'C0009244', 'cui_str': 'Cognitive Therapy'}]","[{'cui': 'C0860603', 'cui_str': 'Anxiety symptoms'}, {'cui': 'C0011581', 'cui_str': 'Neurosis, Depressive'}, {'cui': 'C1319166', 'cui_str': 'Symptom severity (finding)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C0086749', 'cui_str': 'Outcome Measures'}, {'cui': 'C0043227', 'cui_str': 'Work'}, {'cui': 'C0037395', 'cui_str': 'Social Adjustment'}, {'cui': 'C0683253', 'cui_str': 'Psychological Resiliences'}, {'cui': 'C0424000', 'cui_str': 'Suicidal Ideation'}, {'cui': 'C0439793', 'cui_str': 'Severity (attribute)'}]",343.0,0.123356,"Moderate to near-moderate effect sizes favoring the intervention group were observed for anxiety symptoms (P<.001; d=0.47), work/social functioning (P<.001; d=0.39), and resilience (P<.001; d=0.55).","[{'ForeName': 'Mark B', 'Initials': 'MB', 'LastName': 'Schure', 'Affiliation': 'Department of Health & Human Development, Montana State University, Bozeman, MT, United States.'}, {'ForeName': 'Janet C', 'Initials': 'JC', 'LastName': 'Lindow', 'Affiliation': 'Center for Mental Health Research and Recovery, Montana State University, Bozeman, MT, United States.'}, {'ForeName': 'John H', 'Initials': 'JH', 'LastName': 'Greist', 'Affiliation': 'Center for Mental Health Research and Recovery, Montana State University, Bozeman, MT, United States.'}, {'ForeName': 'Paul A', 'Initials': 'PA', 'LastName': 'Nakonezny', 'Affiliation': 'Department of Population and Data Science, University of Texas Southwestern Medical Center, Dallas, TX, United States.'}, {'ForeName': 'Sandra J', 'Initials': 'SJ', 'LastName': 'Bailey', 'Affiliation': 'Department of Health & Human Development, Montana State University, Bozeman, MT, United States.'}, {'ForeName': 'William L', 'Initials': 'WL', 'LastName': 'Bryan', 'Affiliation': 'Center for Mental Health Research and Recovery, Montana State University, Bozeman, MT, United States.'}, {'ForeName': 'Matthew J', 'Initials': 'MJ', 'LastName': 'Byerly', 'Affiliation': 'Center for Mental Health Research and Recovery, Montana State University, Bozeman, MT, United States.'}]",Journal of medical Internet research,['10.2196/14754'] 3340,30226339,"Comparing low-dose bupivacaine with epidural volume extension to standard bupivacaine dosing for short obstetric procedures: a prospective, randomized study.","BACKGROUND Intrathecal bupivacaine's long duration of action can unnecessarily increase the time to meet Postanesthesia Care Unit (PACU) discharge criteria for patients undergoing short obstetric procedures. We sought to use a technique known as epidural volume extension (EVE) to determine if we could provide an adequate surgical block while significantly decreasing the time required to meet PACU discharge criteria for patients undergoing short obstetric procedures. METHODS Fifty participants were randomized into two groups. The control group received a 10 mg of 0.5% isobaric bupivacaine plus 15 µg of fentanyl injection in the intrathecal space via a combined spinal-epidural technique. The EVE group received a 5 mg of 0.5% isobaric bupivacaine plus 15 µg of fentanyl injection in the intrathecal space followed immediately by a 10 mL injection of sterile saline through the epidural needle for the EVE. RESULTS Data were analyzed on 45 of the 50 patients. Time to meet PACU discharge criteria was significantly reduced in the EVE group when compared to the control group (50 vs. 135 minutes, P<0.001). The EVE group had a faster time to complete motor recovery when compared to the control group (66 vs. 181 minutes, P<0.001). Peak block height was similar in both groups at the time of surgery start (T5 vs. T5, P=0.44). CONCLUSIONS The use of low-dose isobaric bupivacaine in combination with 10 mL of saline EVE allows for faster motor recovery and time to meet PACU discharge criteria in patients undergoing short obstetric procedures.",2019,"The EVE group had a faster time to complete motor recovery when compared to the control group (66 vs. 181 minutes, P<0.001).","['short obstetric procedures', 'patients undergoing short obstetric procedures', 'Fifty participants', 'Data were analyzed on 45 of the 50 patients']","['saline EVE', 'bupivacaine', '10 mg of 0.5% isobaric bupivacaine plus 15 µg of fentanyl injection', 'low-dose isobaric bupivacaine', '5 mg of 0.5% isobaric bupivacaine']","['faster time to complete motor recovery', 'Time to meet PACU discharge criteria', 'Peak block height']","[{'cui': 'C1806781', 'cui_str': 'Short (qualifier value)'}, {'cui': 'C0869904', 'cui_str': 'Obstetric procedure (procedure)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}]","[{'cui': 'C0036082', 'cui_str': 'Saline Solution'}, {'cui': 'C0047006', 'cui_str': '(R,S)-N-ethyl-3,4-methylenedioxyamphetamine'}, {'cui': 'C0006400', 'cui_str': 'Bupivacaine'}, {'cui': 'C0444500', 'cui_str': '0.5 (qualifier value)'}, {'cui': 'C0332287', 'cui_str': 'With (attribute)'}, {'cui': 'C4080610', 'cui_str': 'Fentanyl Injection [Sublimaze]'}, {'cui': 'C0445550', 'cui_str': 'Low dose (qualifier value)'}]","[{'cui': 'C0456962', 'cui_str': 'Rapidly'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0034871', 'cui_str': 'Hospital Recovery Rooms'}, {'cui': 'C0012621', 'cui_str': 'Discharge - substance (substance)'}, {'cui': 'C0243161', 'cui_str': 'criteria'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0028778', 'cui_str': 'Obstruction (morphologic abnormality)'}]",50.0,0.081495,"The EVE group had a faster time to complete motor recovery when compared to the control group (66 vs. 181 minutes, P<0.001).","[{'ForeName': 'Mark F', 'Initials': 'MF', 'LastName': 'Powell', 'Affiliation': 'Department of Anesthesiology and Perioperative Medicine, University of Alabama, Birmingham, AL, USA - mfpowell@uabmc.edu.'}, {'ForeName': 'Christopher M', 'Initials': 'CM', 'LastName': 'Blakely', 'Affiliation': 'Department of Anesthesiology and Perioperative Medicine, University of Alabama, Birmingham, AL, USA.'}, {'ForeName': 'Yasser', 'Initials': 'Y', 'LastName': 'Sakawi', 'Affiliation': 'Department of Anesthesiology and Perioperative Medicine, University of Alabama, Birmingham, AL, USA.'}, {'ForeName': 'Michael A', 'Initials': 'MA', 'LastName': 'Frölich', 'Affiliation': 'Department of Anesthesiology and Perioperative Medicine, University of Alabama, Birmingham, AL, USA.'}]",Minerva anestesiologica,['10.23736/S0375-9393.18.12659-9'] 3341,31907248,Physicians' Response to Patients' Quality-of-Life Goals.,"PURPOSE Patients are able to participate in quality-of-life (QOL) discussions, but clinicians struggle to incorporate this information into encounters and shared decision making. We designed a study to determine if a clinician-initiated prompt could make patient visits more goal directed. METHODS Patients were given a previsit questionnaire that included QOL questions. Physicians in the control were given no further prompting. The intervention physicians were prompted to ask a QOL question: what things are you unable to do because of your health problems today? A 2-pronged design was used: 1 prepost group where 3 physicians participated in 5 control and 5 intervention encounters (n = 30) and a randomized group in which 11 physicians and their patients were randomly assigned to control or intervention groups (n = 30). Video recordings of the encounters were reviewed to determine if QOL goals were mentioned and if they were utilized in decision making. RESULTS Fifty-seven (95%) of the 60 patients provided written answers to at least 1 of the QOL questions on the intake form. QOL goals were mentioned during intervention encounters more often than in control groups. QOL information was used in shared decision making in only 4 of the 30 (13%) intervention encounters. CONCLUSIONS Physicians were able to engage in QOL discussions with their patients, but did not translate that information to medical decision making. More research is needed to understand why clinicians opt not to use QOL information and how to make communication more goal directed.",2020,The intervention physicians were prompted to ask a QOL question: what things are you unable to do because of your health problems today?,['Patients were given a previsit questionnaire that included QOL questions'],['5 control and 5 intervention encounters'],"['QOL information', 'QOL goals']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C1947971', 'cui_str': 'Give'}, {'cui': 'C0034394', 'cui_str': 'Questionnaires'}, {'cui': 'C0332257', 'cui_str': 'Including (qualifier value)'}]","[{'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}]","[{'cui': 'C0018017', 'cui_str': 'Goals'}]",,0.0240355,The intervention physicians were prompted to ask a QOL question: what things are you unable to do because of your health problems today?,"[{'ForeName': 'Becky A', 'Initials': 'BA', 'LastName': 'Purkaple', 'Affiliation': 'From Family and Preventive Medicine, Springfield Family Medicine, Springfield, OR (BAP); Department of Family and Preventive Medicine, University of Oklahoma Health Sciences Center, Oklahoma City, OK (ZJN); University of Oklahoma College of Medicine, Oklahoma City, OK (AA, RT); George Lynn Cross Emeritus Professor of Family and Preventive Medicine, University of Oklahoma College of Medicine, Oklahoma City, OK (JWM) beckyp@springfieldfam.com.'}, {'ForeName': 'Zsolt J', 'Initials': 'ZJ', 'LastName': 'Nagykaldi', 'Affiliation': 'From Family and Preventive Medicine, Springfield Family Medicine, Springfield, OR (BAP); Department of Family and Preventive Medicine, University of Oklahoma Health Sciences Center, Oklahoma City, OK (ZJN); University of Oklahoma College of Medicine, Oklahoma City, OK (AA, RT); George Lynn Cross Emeritus Professor of Family and Preventive Medicine, University of Oklahoma College of Medicine, Oklahoma City, OK (JWM).'}, {'ForeName': 'Arrash', 'Initials': 'A', 'LastName': 'Allahyar', 'Affiliation': 'From Family and Preventive Medicine, Springfield Family Medicine, Springfield, OR (BAP); Department of Family and Preventive Medicine, University of Oklahoma Health Sciences Center, Oklahoma City, OK (ZJN); University of Oklahoma College of Medicine, Oklahoma City, OK (AA, RT); George Lynn Cross Emeritus Professor of Family and Preventive Medicine, University of Oklahoma College of Medicine, Oklahoma City, OK (JWM).'}, {'ForeName': 'Robert', 'Initials': 'R', 'LastName': 'Todd', 'Affiliation': 'From Family and Preventive Medicine, Springfield Family Medicine, Springfield, OR (BAP); Department of Family and Preventive Medicine, University of Oklahoma Health Sciences Center, Oklahoma City, OK (ZJN); University of Oklahoma College of Medicine, Oklahoma City, OK (AA, RT); George Lynn Cross Emeritus Professor of Family and Preventive Medicine, University of Oklahoma College of Medicine, Oklahoma City, OK (JWM).'}, {'ForeName': 'James W', 'Initials': 'JW', 'LastName': 'Mold', 'Affiliation': 'From Family and Preventive Medicine, Springfield Family Medicine, Springfield, OR (BAP); Department of Family and Preventive Medicine, University of Oklahoma Health Sciences Center, Oklahoma City, OK (ZJN); University of Oklahoma College of Medicine, Oklahoma City, OK (AA, RT); George Lynn Cross Emeritus Professor of Family and Preventive Medicine, University of Oklahoma College of Medicine, Oklahoma City, OK (JWM).'}]",Journal of the American Board of Family Medicine : JABFM,['10.3122/jabfm.2020.01.190169'] 3342,31799782,"Effect of Liraglutide on Cardiovascular Function and Myocardial Tissue Characteristics in Type 2 Diabetes Patients of South Asian Descent Living in the Netherlands: A Double-Blind, Randomized, Placebo-Controlled Trial.","BACKGROUND The glucagon-like peptide-1 (GLP-1) receptor agonist liraglutide may be beneficial in the regression of diabetic cardiomyopathy. South Asian ethnic groups in particular are at risk of developing type 2 diabetes. PURPOSE To assess the effects of liraglutide on left ventricular (LV) diastolic and systolic function in South Asian type 2 diabetes patients. STUDY TYPE Prospective, double-blind, randomized, placebo-controlled trial. POPULATION Forty-seven type 2 diabetes patients of South Asian ancestry living in the Netherlands, with or without ischemic heart disease, who were randomly assigned to 26-week treatment with liraglutide (1.8 mg/day) or placebo. FIELD STRENGTH/SEQUENCE 3T (balanced steady-state free precession cine MRI, 2D and 4D velocity-encoded MRI, 1 H-MRS, T 1 mapping). ASSESSMENT Primary endpoints were changes in LV diastolic function (early deceleration peak [Edec], ratio of early and late peak filling rate [E/A], estimated LV filling pressure [E/Ea]) and LV systolic function (ejection fraction). Secondary endpoints were changes in aortic stiffness (aortic pulse wave velocity [PWV]), myocardial steatosis (myocardial triglyceride content), and diffuse fibrosis (extracellular volume [ECV]). STATISTICAL TESTS Data were analyzed according to intention-to-treat. Between-group differences were reported as mean (95% confidence interval [CI]) and were assessed using analysis of covariance (ANCOVA). RESULTS Liraglutide (n = 22) compared with placebo (n = 25) did not change Edec (+0.2 mL/s 2 × 10 -3 (-0.3;0.6)), E/A (-0.09 (-0.23;0.05)), E/Ea (+0.1 (-1.2;1.3)) and ejection fraction (0% (-3;2)), but decreased stroke volume (-9 mL (-14;-5)) and increased heart rate (+10 bpm (4;15)). Aortic PWV (+0.5 m/s (-0.6;1.6)), myocardial triglyceride content (+0.21% (-0.09;0.51)), and ECV (-0.2% (-1.4;1.0)) were unaltered. DATA CONCLUSION Liraglutide did not affect LV diastolic and systolic function, aortic stiffness, myocardial triglyceride content, or extracellular volume in Dutch South Asian type 2 diabetes patients with or without coronary artery disease. LEVEL OF EVIDENCE 1 Technical Efficacy Stage: 4 J. Magn. Reson. Imaging 2020;51:1679-1688.",2020,"Liraglutide did not affect LV diastolic and systolic function, aortic stiffness, myocardial triglyceride content, or extracellular volume in Dutch South Asian type 2 diabetes patients with or without coronary artery disease. ","['South Asian type 2 diabetes patients', 'Forty-seven type 2 diabetes patients of South Asian ancestry living in the Netherlands, with or without ischemic heart disease', 'Type 2 Diabetes Patients of South Asian Descent Living in the Netherlands', 'Dutch South Asian type 2 diabetes patients with or without coronary artery disease']","['Placebo', 'glucagon-like peptide-1 (GLP-1) receptor agonist liraglutide', 'Liraglutide', 'placebo', 'liraglutide']","['myocardial triglyceride content', 'left ventricular (LV) diastolic and systolic function', 'stroke volume', 'changes in LV diastolic function (early deceleration peak [Edec], ratio of early and late peak filling rate [E/A], estimated LV filling pressure [E/Ea]) and LV systolic function (ejection fraction', 'Aortic PWV', 'ejection fraction', 'Cardiovascular Function and Myocardial Tissue Characteristics', 'LV diastolic and systolic function, aortic stiffness, myocardial triglyceride content, or extracellular volume', 'heart rate', 'changes in aortic stiffness (aortic pulse wave velocity [PWV]), myocardial steatosis (myocardial triglyceride content), and diffuse fibrosis (extracellular volume [ECV']","[{'cui': 'C0078988', 'cui_str': 'Asians'}, {'cui': 'C0441730', 'cui_str': 'Type 2 (qualifier value)'}, {'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0205453', 'cui_str': '7'}, {'cui': 'C0151744', 'cui_str': 'Ischemic Heart Disease'}, {'cui': 'C0013331', 'cui_str': 'Dutch (ethnic group)'}, {'cui': 'C1956346', 'cui_str': 'Coronary Artery Disease'}]","[{'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0061355', 'cui_str': 'Glucagon-Like Peptide 1'}, {'cui': 'C4543206', 'cui_str': 'Receptor agonist (disposition)'}, {'cui': 'C1456408', 'cui_str': 'liraglutide'}]","[{'cui': 'C0041004', 'cui_str': 'Triacylglycerol'}, {'cui': 'C0456205', 'cui_str': 'Contents (attribute)'}, {'cui': 'C0205091', 'cui_str': 'Left (qualifier value)'}, {'cui': 'C0039155', 'cui_str': 'Systole'}, {'cui': 'C0031843', 'cui_str': 'function'}, {'cui': 'C0038455', 'cui_str': 'Stroke Volume'}, {'cui': 'C0443172', 'cui_str': 'State changes'}, {'cui': 'C0429481', 'cui_str': 'Early fetal heart deceleration (finding)'}, {'cui': 'C0444505', 'cui_str': 'Peak (qualifier value)'}, {'cui': 'C0456603', 'cui_str': 'Ratio (property) (qualifier value)'}, {'cui': 'C1279919', 'cui_str': 'Early (qualifier value)'}, {'cui': 'C0205087', 'cui_str': 'Late (qualifier value)'}, {'cui': 'C0750572', 'cui_str': 'Estimated (qualifier value)'}, {'cui': 'C0460139', 'cui_str': 'Pressure (finding)'}, {'cui': 'C0489482', 'cui_str': 'Ejection fraction'}, {'cui': 'C0003483', 'cui_str': 'Aorta'}, {'cui': 'C0007227', 'cui_str': 'Cardiovascular Physiology'}, {'cui': 'C0027061', 'cui_str': 'Muscle, Cardiac'}, {'cui': 'C3178782', 'cui_str': 'Aortic Stiffness'}, {'cui': 'C0521119', 'cui_str': 'Extracellular (qualifier value)'}, {'cui': 'C0449468', 'cui_str': 'Volume (property) (qualifier value)'}, {'cui': 'C0018810', 'cui_str': 'Cardiac rate'}, {'cui': 'C3494431', 'cui_str': 'Pulse Wave Velocity'}, {'cui': 'C0152254', 'cui_str': 'Fatty degeneration (morphologic abnormality)'}, {'cui': 'C1265984', 'cui_str': 'Diffuse fibrosis'}]",47.0,0.355122,"Liraglutide did not affect LV diastolic and systolic function, aortic stiffness, myocardial triglyceride content, or extracellular volume in Dutch South Asian type 2 diabetes patients with or without coronary artery disease. ","[{'ForeName': 'Elisabeth H M', 'Initials': 'EHM', 'LastName': 'Paiman', 'Affiliation': 'Department of Radiology, Leiden University Medical Centre, Leiden, the Netherlands.'}, {'ForeName': 'Huub J', 'Initials': 'HJ', 'LastName': 'van Eyk', 'Affiliation': 'Department of Medicine, Division of Endocrinology, Leiden University Medical Centre, Leiden, the Netherlands.'}, {'ForeName': 'Minke M A', 'Initials': 'MMA', 'LastName': 'van Aalst', 'Affiliation': 'Department of Radiology, Leiden University Medical Centre, Leiden, the Netherlands.'}, {'ForeName': 'Maurice B', 'Initials': 'MB', 'LastName': 'Bizino', 'Affiliation': 'Department of Radiology, Leiden University Medical Centre, Leiden, the Netherlands.'}, {'ForeName': 'Rob J', 'Initials': 'RJ', 'LastName': 'van der Geest', 'Affiliation': 'Department of Radiology, Leiden University Medical Centre, Leiden, the Netherlands.'}, {'ForeName': 'Jos J M', 'Initials': 'JJM', 'LastName': 'Westenberg', 'Affiliation': 'Department of Radiology, Leiden University Medical Centre, Leiden, the Netherlands.'}, {'ForeName': 'Petronella H', 'Initials': 'PH', 'LastName': 'Geelhoed-Duijvestijn', 'Affiliation': 'Department of Medicine, Haaglanden Medical Centre, The Hague, the Netherlands.'}, {'ForeName': 'Aan V', 'Initials': 'AV', 'LastName': 'Kharagjitsingh', 'Affiliation': 'Department of Diabetology and Endocrinology, University Hospital Brussels, Brussels, Belgium.'}, {'ForeName': 'Patrick C N', 'Initials': 'PCN', 'LastName': 'Rensen', 'Affiliation': 'Department of Medicine, Division of Endocrinology, Leiden University Medical Centre, Leiden, the Netherlands.'}, {'ForeName': 'Johannes W A', 'Initials': 'JWA', 'LastName': 'Smit', 'Affiliation': 'Department of Medicine, Radboud University Medical Centre, Nijmegen, the Netherlands.'}, {'ForeName': 'Ingrid M', 'Initials': 'IM', 'LastName': 'Jazet', 'Affiliation': 'Department of Medicine, Division of Endocrinology, Leiden University Medical Centre, Leiden, the Netherlands.'}, {'ForeName': 'Hildo J', 'Initials': 'HJ', 'LastName': 'Lamb', 'Affiliation': 'Department of Radiology, Leiden University Medical Centre, Leiden, the Netherlands.'}]",Journal of magnetic resonance imaging : JMRI,['10.1002/jmri.27009'] 3343,31814488,"A proof-of-principle study of the short-term effects of 3,4-methylenedioxymethamphetamine (MDMA) on tinnitus and neural connectivity.","Background : This study was conducted to investigate the short-term behavioural and neurophysiological effects of 3,4-methylenedioxymethamphetamine (MDMA) on tinnitus perception. Methods : A double-blind randomized controlled cross-over design. Part 1. Behavioural measures of tinnitus following 30   mg MDMA or placebo administration ( N   =   5 participants) and Part 2. Behavioural measures of tinnitus and correlations between pairs of apriori regions of interest (ROI) using resting-state functional magnetic resonance imaging (rs-fMRI) before and after 70   mg of MDMA or placebo ( N   =   8 participants). Results : The results to MDMA were similar to placebo. For the 70   mg dose, there was a significant reduction after 4   h in annoyance and ignore ratings. RsMRI showed decreased connectivity compared with placebo administration between the left hippocampal, right hippocampal, left amygdala and right amygdala regions, and between the right posterior parahippocampal cortex and the left amygdala after two hours of 70   mg MDMA administration. Increased connectivity compared to placebo administration was found post MDMA between the right post-central gyrus and right posterior and superior temporal gyrus, and between the thalamus and frontoparietal network. Conclusions : Following 70   mg of MDMA two tinnitus rating scales significantly improved. There was, however, a placebo effect. Compared with placebo the rsMRI following the MDMA showed reductions in connectivity between the amygdala, hippocampus and parahippocampal gyrus. There is sufficient proof of concept to support future investigation of MDMA as a treatment for tinnitus.",2020,"RsMRI showed decreased connectivity compared with placebo administration between the left hippocampal, right hippocampal, left amygdala and right amygdala regions, and between the right posterior parahippocampal cortex and the left amygdala after two hours of 70   mg MDMA administration.",[],"['3,4-methylenedioxymethamphetamine (MDMA', ' ', 'placebo', 'MDMA or placebo', 'resting-state functional magnetic resonance imaging (rs-fMRI']","['Behavioural measures of tinnitus', 'tinnitus perception', 'tinnitus rating scales', 'tinnitus and neural connectivity']",[],"[{'cui': 'C0115471', 'cui_str': 'MDMA'}, {'cui': 'C1696465', 'cui_str': 'placebo'}, {'cui': 'C0679218', 'cui_str': 'Resting state'}, {'cui': 'C0376335', 'cui_str': 'fMRI'}]","[{'cui': 'C1879489', 'cui_str': 'Measures (attribute)'}, {'cui': 'C0040264', 'cui_str': 'Ringing-Buzzing-Tinnitus'}, {'cui': 'C0030971', 'cui_str': 'Perception'}, {'cui': 'C0222045'}]",8.0,0.405241,"RsMRI showed decreased connectivity compared with placebo administration between the left hippocampal, right hippocampal, left amygdala and right amygdala regions, and between the right posterior parahippocampal cortex and the left amygdala after two hours of 70   mg MDMA administration.","[{'ForeName': 'G D', 'Initials': 'GD', 'LastName': 'Searchfield', 'Affiliation': 'Eisdell Moore Centre & Audiology Section, The University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'T N E R', 'Initials': 'TNER', 'LastName': 'Poppe', 'Affiliation': 'Biomedical Engineering and Imaging Sciences, Kings College London, London, UK.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Durai', 'Affiliation': 'Eisdell Moore Centre & Audiology Section, The University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'M', 'Initials': 'M', 'LastName': 'Jensen', 'Affiliation': 'Pharmacy, Whakatane Hospital, Bay of Plenty, School of Pharmacy, University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'M A', 'Initials': 'MA', 'LastName': 'Kennedy', 'Affiliation': 'Department of Pathology and Biomedical Science, University of Otago, Christchurch, New Zealand.'}, {'ForeName': 'S', 'Initials': 'S', 'LastName': 'Maggo', 'Affiliation': 'Department of Pathology and Biomedical Science, University of Otago, Christchurch, New Zealand.'}, {'ForeName': 'A L', 'Initials': 'AL', 'LastName': 'Miller', 'Affiliation': 'Department of Pathology and Biomedical Science, University of Otago, Christchurch, New Zealand.'}, {'ForeName': 'J', 'Initials': 'J', 'LastName': 'Park', 'Affiliation': 'Eisdell Moore Centre & Audiology Section, The University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'B R', 'Initials': 'BR', 'LastName': 'Russell', 'Affiliation': 'School of Pharmacy, University of Otago, Dunedin, New Zealand.'}, {'ForeName': 'G S', 'Initials': 'GS', 'LastName': 'Shekhawat', 'Affiliation': 'Auckland University of Technology, Auckland, New Zealand.'}, {'ForeName': 'D', 'Initials': 'D', 'LastName': 'Spiegel', 'Affiliation': 'Eisdell Moore Centre & Audiology Section, The University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'F', 'Initials': 'F', 'LastName': 'Sundram', 'Affiliation': 'Department of Psychological Medicine, Faculty of Medical and Health Sciences, The University of Auckland, Auckland, New Zealand.'}, {'ForeName': 'K', 'Initials': 'K', 'LastName': 'Wise', 'Affiliation': 'Auckland University of Technology, Auckland, New Zealand.'}]",The International journal of neuroscience,['10.1080/00207454.2019.1702544'] 3344,30217513,"Combined Celiac Ganglia and Plexus Neurolysis Shortens Survival, Without Benefit, vs Plexus Neurolysis Alone.","BACKGROUND & AIMS Pancreatic cancer produces debilitating pain that opioids often ineffectively manage. The suboptimal efficacy of celiac plexus neurolysis (CPN) might result from brief contact of the injectate with celiac ganglia. We compared the effects of endoscopic ultrasound-guided celiac ganglia neurolysis (CGN) vs the effects of CPN on pain, quality of life (QOL), and survival. METHODS We performed a randomized, double-blind trial of patients with unresectable pancreatic ductal adenocarcinoma and abdominal pain; 60 patients (age 66.4±11.6 years; male 66%) received CPN and 50 patients (age 66.8±10.0 years; male 56%) received CGN. Primary outcomes included pain control and QOL at week 12 and survival (overall median and 12 months). Secondary outcomes included morphine response, performance status, secondary neurolytic effects, and adverse events. RESULTS Rates of pain response at 12 weeks were 46.2% for CGN and 40.4% for CPN (P = .84). There was no significant difference in improvement of QOL between the techniques. The median survival time was significantly shorter for patients receiving CGN (5.59 months) compared to (10.46 months) (hazard ratio for CGN, 1.49; 95% CI, 1.02-2.19; P = .042), particularly for patients with non-metastatic disease (hazard ratio for CGN, 2.95; 95% CI, 1.61-5.45; P < .001). Rates of survival at 12 months were 42% for patients who underwent CPN vs 26% for patients who underwent CGN. The number of adverse events did not differ between techniques. CONCLUSION In a prospective study of patients with unresectable pancreatic ductal adenocarcinoma and abdominal pain, we found CGN to reduce median survival time without improving pain, QOL, or adverse events, compared to CPN. The role of CGN must be therefore be reassessed. Clinicaltrials.gov no: NCT01615653.",2019,Rates of survival at 12 months were 42% for patients who underwent CPN vs 26% for patients who underwent CGN.,"['patients with unresectable pancreatic ductal adenocarcinoma and abdominal pain', 'patients with unresectable pancreatic ductal adenocarcinoma and abdominal pain; 60 patients (age 66.4±11.6 years; male 66%) received CPN and 50 patients (age 66.8±10.0 years; male 56%) received']","['celiac plexus neurolysis (CPN', 'endoscopic ultrasound-guided celiac ganglia neurolysis (CGN', 'CGN', 'CPN']","['QOL', 'pain control and QOL at week 12 and survival', 'Rates of survival', 'median survival time', 'pain response', 'morphine response, performance status, secondary neurolytic effects, and adverse events', 'median survival time without improving pain, QOL, or adverse events', 'number of adverse events', 'pain, quality of life (QOL), and survival']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0001418', 'cui_str': 'Adenoma, Malignant'}, {'cui': 'C0000737', 'cui_str': 'Abdominal Pain'}, {'cui': 'C0001792', 'cui_str': 'Elderly'}, {'cui': 'C0439234', 'cui_str': 'year (qualifier value)'}, {'cui': 'C0086582', 'cui_str': 'Males'}]","[{'cui': 'C0007572', 'cui_str': 'Solar Plexus'}, {'cui': 'C0196878', 'cui_str': 'Neurolysis (procedure)'}, {'cui': 'C0376443', 'cui_str': 'Ultrasonography, Endoscopic'}, {'cui': 'C0302614', 'cui_str': 'Guide - clinical instrument'}, {'cui': 'C0007571', 'cui_str': 'Celiac ganglion structure'}]","[{'cui': 'C1304888', 'cui_str': 'Pain control (procedure)'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0220921', 'cui_str': 'survival'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C2919552', 'cui_str': 'Survival time'}, {'cui': 'C0030193', 'cui_str': 'Pain'}, {'cui': 'C0026549', 'cui_str': 'Morphine'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C1522484', 'cui_str': 'metastatic'}, {'cui': 'C1280500', 'cui_str': 'Effect (qualifier value)'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0184511', 'cui_str': 'Improved (qualifier value)'}, {'cui': 'C0237753', 'cui_str': 'Number (attribute)'}, {'cui': 'C0034380'}]",,0.345861,Rates of survival at 12 months were 42% for patients who underwent CPN vs 26% for patients who underwent CGN.,"[{'ForeName': 'Michael J', 'Initials': 'MJ', 'LastName': 'Levy', 'Affiliation': 'Division of Gastroenterology, Mayo Clinic, Rochester, Minnesota. Electronic address: levy.michael@mayo.edu.'}, {'ForeName': 'Ferga C', 'Initials': 'FC', 'LastName': 'Gleeson', 'Affiliation': 'Division of Gastroenterology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Mark D', 'Initials': 'MD', 'LastName': 'Topazian', 'Affiliation': 'Division of Gastroenterology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Larissa L', 'Initials': 'LL', 'LastName': 'Fujii-Lau', 'Affiliation': 'Division of Gastroenterology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Felicity T', 'Initials': 'FT', 'LastName': 'Enders', 'Affiliation': 'Division of Biomedical Statistics and Informatics, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Joseph J', 'Initials': 'JJ', 'LastName': 'Larson', 'Affiliation': 'Division of Biomedical Statistics and Informatics, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Kristin', 'Initials': 'K', 'LastName': 'Mara', 'Affiliation': 'Division of Biomedical Statistics and Informatics, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Barham K', 'Initials': 'BK', 'LastName': 'Abu Dayyeh', 'Affiliation': 'Division of Gastroenterology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Steven R', 'Initials': 'SR', 'LastName': 'Alberts', 'Affiliation': 'Division of Medical Oncology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Christopher L', 'Initials': 'CL', 'LastName': 'Hallemeier', 'Affiliation': 'Department of Radiation Oncology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Prasad G', 'Initials': 'PG', 'LastName': 'Iyer', 'Affiliation': 'Division of Gastroenterology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Michael L', 'Initials': 'ML', 'LastName': 'Kendrick', 'Affiliation': 'Department of Surgery, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'William D', 'Initials': 'WD', 'LastName': 'Mauck', 'Affiliation': 'Department of Pain Medicine, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Randall K', 'Initials': 'RK', 'LastName': 'Pearson', 'Affiliation': 'Division of Gastroenterology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Bret T', 'Initials': 'BT', 'LastName': 'Petersen', 'Affiliation': 'Division of Gastroenterology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Elizabeth', 'Initials': 'E', 'LastName': 'Rajan', 'Affiliation': 'Division of Gastroenterology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Naoki', 'Initials': 'N', 'LastName': 'Takahashi', 'Affiliation': 'Department of Radiology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Santhi S', 'Initials': 'SS', 'LastName': 'Vege', 'Affiliation': 'Division of Gastroenterology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Kenneth K', 'Initials': 'KK', 'LastName': 'Wang', 'Affiliation': 'Division of Gastroenterology, Mayo Clinic, Rochester, Minnesota.'}, {'ForeName': 'Suresh T', 'Initials': 'ST', 'LastName': 'Chari', 'Affiliation': 'Division of Gastroenterology, Mayo Clinic, Rochester, Minnesota.'}]",Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association,['10.1016/j.cgh.2018.08.040'] 3345,31599120,Laparoscopic modified lateral transabdominal preperitoneal approach for Spigelian hernia repair: An easier approach to a rare condition.,"INTRODUCTION Both laparoscopic and open approaches are well accepted for spigelian hernia (SH) repair. Several techniques for SH repair are described in literature. In our study, eight patients underwent laparoscopic SH repair. A modified lateral TAPP approach was used in four cases and then compared with the conventional TAPP approach. METHODS From January 2015 to January 2017, eight cases of SH were treated using the laparoscopic TAPP approach. Four cases underwent surgery by the conventional laparoscopic TAPP approach (group I). For the other four, modified lateral approach transabdominal preperitoneal technique was used (group II). Postoperative pain, operative time, length of hospital stay, and complications were compared between the groups. Patients were followed up for a minimum period of 1 year. RESULT Among the eight cases, the mean age was 52 years in group I and 50 years in group II, mean defect size was 23 mm in group I and 28 mm in group II, mean length of hospital stay was 1.50 days in group I and 1.25 days in group II, and operative time was 61 minutes in group I and 51 minutes in group II. There was no remarkable difference in complications or length of hospital stay between the groups. The groups were comparable in all other parameters, but the lateral approach was ergonomically better for the surgeon. CONCLUSION Of the approaches described for laparoscopic SH repair, the modified lateral TAPP approach is more convenient because it provides better and more adequate lateral and inferior space access and is ergonomically better for surgeons.",2020,There was no remarkable difference in complications or length of hospital stay between the groups.,['Spigelian hernia repair'],"['modified lateral approach transabdominal preperitoneal technique', 'conventional laparoscopic TAPP approach', 'Laparoscopic modified lateral transabdominal preperitoneal approach', 'laparoscopic TAPP approach', 'laparoscopic SH repair']","['complications or length of hospital stay', 'mean defect size', 'operative time', 'Postoperative pain, operative time, length of hospital stay, and complications', 'mean length of hospital stay']","[{'cui': 'C0392508', 'cui_str': 'Spigelian hernia (disorder)'}, {'cui': 'C0374711', 'cui_str': 'Surgical repair (procedure)'}]","[{'cui': 'C0392747', 'cui_str': 'Altered (qualifier value)'}, {'cui': 'C0205514', 'cui_str': 'Lateral approach (qualifier value)'}, {'cui': 'C0205496', 'cui_str': 'Abdominal approach (qualifier value)'}, {'cui': 'C0442170', 'cui_str': 'Preperitoneal approach (qualifier value)'}, {'cui': 'C0025664', 'cui_str': 'techniques'}, {'cui': 'C0439858', 'cui_str': 'Conventional (qualifier value)'}, {'cui': 'C0163807', 'cui_str': 'tetra-4-amidinophenoxypropane'}, {'cui': 'C1292724', 'cui_str': 'Procedure approach'}, {'cui': 'C0205093', 'cui_str': 'Lateral (qualifier value)'}, {'cui': 'C0374711', 'cui_str': 'Surgical repair (procedure)'}]","[{'cui': 'C0009566', 'cui_str': 'Complication (disorder)'}, {'cui': 'C1444754', 'cui_str': 'Length property'}, {'cui': 'C3489408', 'cui_str': 'Hospital Stay'}, {'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0243067', 'cui_str': 'defects'}, {'cui': 'C0456389', 'cui_str': 'Size (attribute)'}, {'cui': 'C3494201', 'cui_str': 'Length of Operative Time'}, {'cui': 'C0030201', 'cui_str': 'Pain, Postoperative'}]",,0.0209534,There was no remarkable difference in complications or length of hospital stay between the groups.,"[{'ForeName': 'Akshay', 'Initials': 'A', 'LastName': 'Naik', 'Affiliation': 'Department of Digestive Diseases and Minimal Access Surgery, Digestive Disease Centre, Zen Hospital, Mumbai, India.'}, {'ForeName': 'Pranav', 'Initials': 'P', 'LastName': 'Mandovra', 'Affiliation': 'Department of Digestive Diseases and Minimal Access Surgery, Digestive Disease Centre, Zen Hospital, Mumbai, India.'}, {'ForeName': 'Roy V', 'Initials': 'RV', 'LastName': 'Patankar', 'Affiliation': 'Department of Digestive Diseases and Minimal Access Surgery, Digestive Disease Centre, Zen Hospital, Mumbai, India.'}]",Asian journal of endoscopic surgery,['10.1111/ases.12756'] 3346,31924332,"A phase 3 randomized, open-label, multicenter trial for safety and efficacy of combined trabectedin and pegylated liposomal doxorubicin therapy for recurrent ovarian cancer.","OBJECTIVE This phase 3 study aimed to compare overall survival (OS) of women with platinum-sensitive, recurrent ovarian cancer (ROC) treated with third-line trabectedin (T) + pegylated liposomal doxorubicin (PLD) vs. PLD monotherapy. METHODS Women with advanced-relapsed epithelial ovarian cancer were randomly assigned 1: 1 to intravenous infusions of either T + PLD (trabectedin 1.1 mg/m 2 for 3 h; PLD 30 mg/m 2 for 1.5 h, every 3 weeks) or PLD (50 mg/m 2 for 1.5 h, every 4 weeks). Primary endpoint was OS. Secondary endpoints included investigator-assessed progression free survival (PFS) and objective response rates (ORR). At randomization, patients were stratified by time from last dose of first-line platinum therapy to disease progression, ECOG grade 0 or 1, BRCA1/2 germline mutational status, and prior PLD therapy. Exploratory endpoints included OS, PFS, and ORR in the stratified subgroups (PFI, ECOG, BRCA1/2 status, and prior PLD therapy). This trial is registered with ClinicalTrials.gov, number NCT01846611. RESULTS 576 patients were randomized (T + PLD, n = 289; PLD, n = 287). Median OS was 23.8 months with T + PLD vs. 22.2 months with PLD (HR:0.92, 95%CI:0.73-1.18; p = 0.52). Median PFS was 7.52 vs. 7.26 months (HR:0.93, 95%CI:0.76-1.15; p = 0.52); ORR was 46% vs. 35.9% (OR:1.52, 95%CI:1.07-2.16; p = 0.01). Patients with BRCA1/2 mutations had median OS of 34.2 months with T + PLD vs. 20.9 months with PLD (HR:0.54, 95%CI:0.33-0.90; p = 0.016). Patients with BRCA1/2 mutations had median PFS of 10.1 months with T + PLD vs. 7.6 months with PLD (HR:0.72, 95%CI:0.48-1.08; p = 0.039). Patients with BRCA1/2 mutations and a 6-12 months platinum-free interval (PFI), median OS was 31.5 vs. 14.9 months, respectively (HR:0.37, 95%CI:0.17-0.82; p = 0.011). Grade 3-4 AEs were higher in T + PLD (79%) vs. PLD (54%). CONCLUSION Combination of T and PLD did not show favorable OS benefit nor safety; however, patients with germline BRCA1/2 mutations and/or a PFI of 6-12 months appear to have clinically relevant survival benefit with T + PLD. No new safety signals were identified.",2020,"Median PFS was 7.52 vs. 7.26 months (HR:0.93, 95%CI:0.76-1.15; p = 0.52); ORR was 46% vs. 35.9% (OR:1.52, 95%CI:1.07-2.16; p = 0.01).","['576 patients', 'women with platinum-sensitive, recurrent ovarian cancer (ROC) treated with', 'recurrent ovarian cancer', 'Women with advanced-relapsed epithelial ovarian cancer']","['T\xa0+\xa0PLD (trabectedin 1.1\xa0mg/m 2 for 3\xa0h; PLD 30\xa0mg/m 2 for 1.5\xa0h, every 3\xa0weeks) or PLD', 'third-line trabectedin (T)\xa0+\xa0pegylated liposomal doxorubicin (PLD) vs. PLD monotherapy', 'combined trabectedin and pegylated liposomal doxorubicin therapy']","['platinum-free interval (PFI), median OS', 'Median OS', 'ORR', 'investigator-assessed progression free survival (PFS) and objective response rates (ORR', 'median OS', 'OS, PFS, and ORR in the stratified subgroups (PFI, ECOG, BRCA1/2 status, and prior PLD therapy', 'Median PFS', 'median PFS', 'overall survival (OS', 'OS']","[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0043210', 'cui_str': 'Girls'}, {'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C0332324', 'cui_str': 'Sensitive (qualifier value)'}, {'cui': 'C2945760', 'cui_str': 'Recurrent (qualifier value)'}, {'cui': 'C1140680', 'cui_str': 'Ovary Cancer'}, {'cui': 'C0332293', 'cui_str': 'Treated with (attribute)'}, {'cui': 'C0205179', 'cui_str': 'Advanced (qualifier value)'}, {'cui': 'C0035020', 'cui_str': 'Relapse'}, {'cui': 'C0677886', 'cui_str': 'Carcinoma, Ovarian Epithelial'}]","[{'cui': 'C0044369', 'cui_str': 'Pyridinium, 1-dodecyl-4-formyl-3-hydroxy-5-(hydroxymethyl)-2-methyl-, chloride'}, {'cui': 'C1311070', 'cui_str': 'trabectedin'}, {'cui': 'C4517491', 'cui_str': 'One point one'}, {'cui': 'C0041119', 'cui_str': 'Hydrogen-3'}, {'cui': 'C3844012', 'cui_str': '1.5'}, {'cui': 'C0439230', 'cui_str': 'week (qualifier value)'}, {'cui': 'C0205132', 'cui_str': 'Linear (qualifier value)'}, {'cui': 'C0717726', 'cui_str': 'doxorubicin liposome'}, {'cui': 'C0336789', 'cui_str': 'Combine'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}]","[{'cui': 'C1098768', 'cui_str': '(diethylenetriamine)-platinum(II)'}, {'cui': 'C1272706', 'cui_str': 'Interval'}, {'cui': 'C2939193', 'cui_str': 'Median (qualifier value)'}, {'cui': 'C0035173', 'cui_str': 'Investigators'}, {'cui': 'C0242792', 'cui_str': 'Progression-Free Survival'}, {'cui': 'C1571702', 'cui_str': 'Objective observation'}, {'cui': 'C0430797', 'cui_str': 'Intracranial EEG'}, {'cui': 'C0449438', 'cui_str': 'Status (attribute)'}, {'cui': 'C0044369', 'cui_str': 'Pyridinium, 1-dodecyl-4-formyl-3-hydroxy-5-(hydroxymethyl)-2-methyl-, chloride'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0282416', 'cui_str': 'Overall'}, {'cui': 'C0220921', 'cui_str': 'survival'}]",576.0,0.210976,"Median PFS was 7.52 vs. 7.26 months (HR:0.93, 95%CI:0.76-1.15; p = 0.52); ORR was 46% vs. 35.9% (OR:1.52, 95%CI:1.07-2.16; p = 0.01).","[{'ForeName': 'Bradley J', 'Initials': 'BJ', 'LastName': 'Monk', 'Affiliation': 'Arizona Oncology (US Oncology Network), Phoenix, AZ, USA; University of Arizona, AZ, USA; Creighton University, USA. Electronic address: Bradley.Monk@usoncology.com.'}, {'ForeName': 'Thomas J', 'Initials': 'TJ', 'LastName': 'Herzog', 'Affiliation': 'University of Cincinnati Cancer Institute, University of Cincinnati, Cincinnati, OH, USA.'}, {'ForeName': 'George', 'Initials': 'G', 'LastName': 'Wang', 'Affiliation': 'Janssen Research & Development, Spring House, PA, USA.'}, {'ForeName': 'Spyros', 'Initials': 'S', 'LastName': 'Triantos', 'Affiliation': 'Janssen Research & Development, Spring House, PA, USA.'}, {'ForeName': 'Scott', 'Initials': 'S', 'LastName': 'Maul', 'Affiliation': 'Janssen Research & Development, Los Angeles, CA, USA.'}, {'ForeName': 'Roland', 'Initials': 'R', 'LastName': 'Knoblauch', 'Affiliation': 'Janssen Research & Development, Spring House, PA, USA.'}, {'ForeName': 'Tracy', 'Initials': 'T', 'LastName': 'McGowan', 'Affiliation': 'Janssen Scientific Affairs, LLC, Horsham, PA, USA.'}, {'ForeName': 'Waleed S W', 'Initials': 'WSW', 'LastName': 'Shalaby', 'Affiliation': 'Janssen Scientific Affairs, LLC, Horsham, PA, USA.'}, {'ForeName': 'Robert L', 'Initials': 'RL', 'LastName': 'Coleman', 'Affiliation': 'The University of Texas MD Anderson Cancer Center, Houston, TX, USA.'}]",Gynecologic oncology,['10.1016/j.ygyno.2019.12.043'] 3347,30932955,Effects of 24-week Toll-like receptor 9 agonist treatment in HIV type 1+ individuals.,"DESIGN This was an exploratory, single-arm clinical trial that tested the immune enhancement effects of 24-weeks of Toll-like receptor 9 (TLR9) agonist (MGN1703; Lefitolimod; 60 mg × 2 weekly) therapy. METHODS We enrolled HIV-1-infected individuals on suppressive combination antiretroviral therapy. Safety was assessed throughout the study. The primary outcome was reduction in total CD4 T-cell viral DNA levels. Secondary outcomes included safety, detailed immunological and virological analyses, and time to viral rebound (viral load > 5000 copies/ml) after randomization into an analytical treatment interruption (ATI). RESULTS A total of 12 individuals completed the treatment phase and nine completed the ATI. Adverse events were limited and consistent with previous reports for MGN1703. Although the dosing regimen led to potent T-cell activation and increased HIV-1-specific T-cell responses, there were no cohort-wide changes in persistent virus (total CD4 T cells viral DNA; P = 0.34). No difference in time to rebound was observed between the ATI arms (log rank P = 0.25). One of nine ATI participants, despite harboring a large replication-competent reservoir, controlled viremia for 150 days via both HIV-1-specific cellular and antibody-mediated immune responses. CONCLUSION A period of 24 weeks of MGN1703 treatment was safe and improved innate as well as HIV-1-specific adaptive immunity in HIV-1+ individuals. These findings support the incorporation of TLR9 agonism into combination HIV-1 cure strategies. TRIAL NAME AND REGISTRATION TLR9 Enhancement of antiviral immunity in chronic HIV-1 infection: a phase 1B/2A trial; ClinicalTrials.gov NCT02443935.",2019,A period of 24 weeks of MGN1703 treatment was safe and improved innate as well as HIV-1-specific adaptive immunity in HIV-1+ individuals.,"['chronic HIV-1 infection', 'enrolled HIV-1-infected individuals on suppressive combination antiretroviral therapy', 'A total of 12 individuals completed the treatment phase and nine completed the ATI', 'HIV type 1+ individuals', 'HIV-1+ individuals']","['MGN1703', 'Toll-like receptor 9 (TLR9) agonist (MGN1703; Lefitolimod']","['TLR9 Enhancement of antiviral immunity', 'Adverse events', 'HIV-1-specific T-cell responses', 'safety, detailed immunological and virological analyses, and time to viral rebound (viral load > 5000\u200acopies/ml) after randomization into an analytical treatment interruption (ATI', 'HIV-1-specific adaptive immunity', 'total CD4 T-cell viral DNA levels', 'time to rebound', 'Safety']","[{'cui': 'C0205191', 'cui_str': 'Chronic (qualifier value)'}, {'cui': 'C2363741', 'cui_str': 'HIV-1 infection'}, {'cui': 'C0019704', 'cui_str': 'HIV-I'}, {'cui': 'C0237401', 'cui_str': 'Individual (person)'}, {'cui': 'C0205367', 'cui_str': 'Suppressive (qualifier value)'}, {'cui': 'C1963724', 'cui_str': 'Antiretroviral therapy'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0205197', 'cui_str': 'Complete (qualifier value)'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0585064', 'cui_str': 'Numerical phases (qualifier value)'}, {'cui': 'C0019682', 'cui_str': 'HTLV-III'}, {'cui': 'C0441729', 'cui_str': 'Type 1 (qualifier value)'}]","[{'cui': 'C2986392', 'cui_str': 'MGN1703'}, {'cui': 'C0963057', 'cui_str': 'CD289 Antigen'}, {'cui': 'C0243192', 'cui_str': 'agonists'}]","[{'cui': 'C1627358', 'cui_str': 'Refractive surgery enhancement'}, {'cui': 'C1874329', 'cui_str': 'Antivirals, topical'}, {'cui': 'C0020964', 'cui_str': 'Immunity'}, {'cui': 'C0877248', 'cui_str': 'Adverse event'}, {'cui': 'C0019704', 'cui_str': 'HIV-I'}, {'cui': 'C0205369', 'cui_str': 'Specified'}, {'cui': 'C0039194', 'cui_str': 'Thymus-Dependent Lymphocytes'}, {'cui': 'C0036043', 'cui_str': 'Safety'}, {'cui': 'C0205470', 'cui_str': 'Immunologic (qualifier value)'}, {'cui': 'C0205466', 'cui_str': 'virology'}, {'cui': 'C1524024', 'cui_str': 'analysis'}, {'cui': 'C1632851', 'cui_str': 'Times'}, {'cui': 'C0376705', 'cui_str': 'Viral Burden'}, {'cui': 'C4319610', 'cui_str': '5000 (qualifier value)'}, {'cui': 'C0034656', 'cui_str': 'Randomization'}, {'cui': 'C0087111', 'cui_str': 'Therapy'}, {'cui': 'C0678209', 'cui_str': 'Acquired Immunity'}, {'cui': 'C0439810', 'cui_str': 'Total (qualifier value)'}, {'cui': 'C0012939', 'cui_str': 'DNA, Viral'}, {'cui': 'C0456079', 'cui_str': 'Level (attribute)'}]",12.0,0.323629,A period of 24 weeks of MGN1703 treatment was safe and improved innate as well as HIV-1-specific adaptive immunity in HIV-1+ individuals.,"[{'ForeName': 'Line K', 'Initials': 'LK', 'LastName': 'Vibholm', 'Affiliation': 'Department of Infectious Diseases, Aarhus University Hospital.'}, {'ForeName': 'Christina V', 'Initials': 'CV', 'LastName': 'Konrad', 'Affiliation': 'Institute of Clinical Medicine, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Mariane H', 'Initials': 'MH', 'LastName': 'Schleimann', 'Affiliation': 'Department of Infectious Diseases, Aarhus University Hospital.'}, {'ForeName': 'Giacomo', 'Initials': 'G', 'LastName': 'Frattari', 'Affiliation': 'Department of Infectious Diseases, Aarhus University Hospital.'}, {'ForeName': 'Anni', 'Initials': 'A', 'LastName': 'Winckelmann', 'Affiliation': 'Department of Infectious Diseases, Aarhus University Hospital.'}, {'ForeName': 'Vibeke', 'Initials': 'V', 'LastName': 'Klastrup', 'Affiliation': 'Department of Infectious Diseases, Aarhus University Hospital.'}, {'ForeName': 'Nanna M', 'Initials': 'NM', 'LastName': 'Jensen', 'Affiliation': 'Department of Infectious Diseases, Aarhus University Hospital.'}, {'ForeName': 'Sanne S', 'Initials': 'SS', 'LastName': 'Jensen', 'Affiliation': 'Department of Infectious Diseases, Aarhus University Hospital.'}, {'ForeName': 'Manuel', 'Initials': 'M', 'LastName': 'Schmidt', 'Affiliation': 'Mologen AG.'}, {'ForeName': 'Burghardt', 'Initials': 'B', 'LastName': 'Wittig', 'Affiliation': 'Mologen AG.'}, {'ForeName': 'Kaja', 'Initials': 'K', 'LastName': 'Zuwala', 'Affiliation': 'Department of Infectious Diseases, Aarhus University Hospital.'}, {'ForeName': 'Katharina', 'Initials': 'K', 'LastName': 'Mack', 'Affiliation': 'Institute of Clinical Medicine, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Rikke', 'Initials': 'R', 'LastName': 'Olesen', 'Affiliation': 'Institute of Clinical Medicine, Aarhus University, Aarhus, Denmark.'}, {'ForeName': 'Stephane', 'Initials': 'S', 'LastName': 'Hua', 'Affiliation': 'Ragon Institute of MGH, MIT and Harvard, Boston, Massachusetts, USA.'}, {'ForeName': 'Mathias', 'Initials': 'M', 'LastName': 'Lichterfeld', 'Affiliation': 'Ragon Institute of MGH, MIT and Harvard, Boston, Massachusetts, USA.'}, {'ForeName': 'Lars', 'Initials': 'L', 'LastName': 'Østergaard', 'Affiliation': 'Department of Infectious Diseases, Aarhus University Hospital.'}, {'ForeName': 'Paul W', 'Initials': 'PW', 'LastName': 'Denton', 'Affiliation': 'Department of Infectious Diseases, Aarhus University Hospital.'}, {'ForeName': 'Martin', 'Initials': 'M', 'LastName': 'Tolstrup', 'Affiliation': 'Department of Infectious Diseases, Aarhus University Hospital.'}, {'ForeName': 'Ole S', 'Initials': 'OS', 'LastName': 'Søgaard', 'Affiliation': 'Department of Infectious Diseases, Aarhus University Hospital.'}]","AIDS (London, England)",['10.1097/QAD.0000000000002213'] 3348,31935109,Time to exhaustion during cycling is not well predicted by critical power calculations.,"Three to 5 cycling tests to exhaustion allow prediction of time to exhaustion (TTE) at power output based on calculation of critical power (CP). We aimed to determine the accuracy of CP predictions of TTE at power outputs habitually endured by cyclists. Fourteen endurance-trained male cyclists underwent 4 randomized cycle-ergometer TTE tests at power outputs eliciting ( i ) mean Wingate anaerobic test (WAnT mean ), ( ii ) maximal oxygen consumption, ( iii ) respiratory compensation threshold (VT 2 ), and ( iv ) maximal lactate steady state (MLSS). Tests were conducted in duplicate with coefficient of variation of 5%-9%. Power outputs were 710 ± 63 W for WAnT mean , 366 ± 26 W for maximal oxygen consumption, 302 ± 31 W for VT 2 and 247 ± 20 W for MLSS. Corresponding TTE were 00:29 ± 00:06, 03:23 ± 00:45, 11:29 ± 05:07, and 76:05 ± 13:53 min:s, respectively. Power output associated with CP was only 2% lower than MLSS (242 ± 19 vs. 247 ± 20 W; P < 0.001). The CP predictions overestimated TTE at WAnT mean (00:24 ± 00:10 mm:ss) and MLSS (04:41 ± 11:47 min:s), underestimated TTE at VT 2 (-04:18 ± 03:20 mm:ss; P < 0.05), and correctly predicted TTE at maximal oxygen consumption. In summary, CP accurately predicts MLSS power output and TTE at maximal oxygen consumption. However, it should not be used to estimate time to exhaustion in trained cyclists at higher or lower power outputs (e.g., sprints and 40-km time trials). Novelty CP calculation enables to predict TTE at any cycling power output. We tested those predictions against measured TTE in a wide range of cycling power outputs. CP appropriately predicted TTE at maximal oxygen consumption intensity but err at higher and lower cycling power outputs.",2020,Power-output associated with CP was only 2% lower than MLSS (242±19 vs. 247±20 W; P<0.001).,['Fourteen endurance-trained male cyclists'],['• Critical power (CP) calculation'],"['mean Wingate anaerobic test (WAnTmean), ii) VO2max, iii) respiratory compensation threshold (VT2) and iv) maximal lactate steady state (MLSS', 'Novelty bullets']","[{'cui': 'C3715152', 'cui_str': '14'}, {'cui': 'C0518031', 'cui_str': 'Endurance capacity'}, {'cui': 'C0336809', 'cui_str': 'Railway train, device (physical object)'}, {'cui': 'C0086582', 'cui_str': 'Males'}]",[],"[{'cui': 'C0444504', 'cui_str': 'Mean (qualifier value)'}, {'cui': 'C0392366', 'cui_str': 'Tests (qualifier value)'}, {'cui': 'C0439070', 'cui_str': 'III'}, {'cui': 'C0152058', 'cui_str': 'Compensation (finding)'}, {'cui': 'C0449864', 'cui_str': 'Threshold (property) (qualifier value)'}, {'cui': 'C0205289', 'cui_str': 'Maximal (qualifier value)'}, {'cui': 'C0202115', 'cui_str': 'Lactic acid measurement (procedure)'}, {'cui': 'C0205361', 'cui_str': 'Steady (qualifier value)'}, {'cui': 'C1301808', 'cui_str': 'State'}, {'cui': 'C0336699', 'cui_str': 'Bullet, device (physical object)'}]",14.0,0.0296645,Power-output associated with CP was only 2% lower than MLSS (242±19 vs. 247±20 W; P<0.001).,"[{'ForeName': 'Jesus G', 'Initials': 'JG', 'LastName': 'Pallarés', 'Affiliation': 'Human Performance and Sports Science Laboratory. University of Murcia, 30720, Murcia, Spain.'}, {'ForeName': 'Jose R', 'Initials': 'JR', 'LastName': 'Lillo-Bevia', 'Affiliation': 'Human Performance and Sports Science Laboratory. University of Murcia, 30720, Murcia, Spain.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Morán-Navarro', 'Affiliation': 'Human Performance and Sports Science Laboratory. University of Murcia, 30720, Murcia, Spain.'}, {'ForeName': 'Victor', 'Initials': 'V', 'LastName': 'Cerezuela-Espejo', 'Affiliation': 'Human Performance and Sports Science Laboratory. University of Murcia, 30720, Murcia, Spain.'}, {'ForeName': 'Ricardo', 'Initials': 'R', 'LastName': 'Mora-Rodriguez', 'Affiliation': 'Exercise Physiology Laboratory at Toledo. University of Castilla-La Mancha, Avda Carlos III, s/n, 47051, Toledo, Spain.'}]","Applied physiology, nutrition, and metabolism = Physiologie appliquee, nutrition et metabolisme",['10.1139/apnm-2019-0637'] 3349,31985173,Sexism Interacts with Patient-Physician Gender Concordance in Influencing Patient Control Preferences: Findings from a Vignette Experimental Design.,"BACKGROUND Patient preferences regarding their involvement in shared treatments decisions is fundamental in clinical practice. Previous evidences demonstrated a large heterogeneity in these preferences. However, only few studies have analysed the influence of patients' individual differences, contextual and situational qualities, and their complex interaction in explaining this variability. METHODS We assessed the role of the interaction of patient's sociodemographic and psychological factors with a physician's gender. Specifically, we focused on patient gender and attitudes toward male or female physicians. One hundred fifty-three people participated in this randomised controlled study and were randomly assigned to one of two experimental conditions in which they were asked to imagine discussing their treatment with a male and a female doctor. RESULTS Analyses showed an interplay between attitude towards women and the gender of patients and doctors, explaining interindividual variability in patient preferences. CONCLUSIONS In conclusion, patients' attitudes toward the physicians' gender constitutes a relevant characteristic that may influence the degree of control patients want to have and the overall patient-physician relationship.",2020,"RESULTS Analyses showed an interplay between attitude towards women and the gender of patients and doctors, explaining interindividual variability in patient preferences. ","['patient gender and attitudes toward male or female physicians', 'One hundred fifty-three people participated', 'Patient Control Preferences']",[],[],"[{'cui': 'C0030705', 'cui_str': 'Patients'}, {'cui': 'C0079399', 'cui_str': 'Gender'}, {'cui': 'C0004271', 'cui_str': 'Attitude'}, {'cui': 'C0086582', 'cui_str': 'Males'}, {'cui': 'C0086287', 'cui_str': 'Females'}, {'cui': 'C0031831', 'cui_str': 'Physicians'}, {'cui': 'C1704407', 'cui_str': '100 (qualifier value)'}, {'cui': 'C2587213', 'cui_str': 'Controlled (qualifier value)'}, {'cui': 'C0558295', 'cui_str': 'Preferences (qualifier value)'}]",[],[],153.0,0.0465349,"RESULTS Analyses showed an interplay between attitude towards women and the gender of patients and doctors, explaining interindividual variability in patient preferences. ","[{'ForeName': 'Dario', 'Initials': 'D', 'LastName': 'Monzani', 'Affiliation': 'Applied Research Division for Cognitive and Psychological Science, IEO, European Institute of Oncology IRCCS, Milan, Italy.'}, {'ForeName': 'Laura', 'Initials': 'L', 'LastName': 'Vergani', 'Affiliation': 'Applied Research Division for Cognitive and Psychological Science, IEO, European Institute of Oncology IRCCS, Milan, Italy.'}, {'ForeName': 'Silvia Francesca Maria', 'Initials': 'SFM', 'LastName': 'Pizzoli', 'Affiliation': 'Applied Research Division for Cognitive and Psychological Science, IEO, European Institute of Oncology IRCCS, Milan, Italy.'}, {'ForeName': 'Giulia', 'Initials': 'G', 'LastName': 'Marton', 'Affiliation': 'Applied Research Division for Cognitive and Psychological Science, IEO, European Institute of Oncology IRCCS, Milan, Italy.'}, {'ForeName': 'Ketti', 'Initials': 'K', 'LastName': 'Mazzocco', 'Affiliation': 'Applied Research Division for Cognitive and Psychological Science, IEO, European Institute of Oncology IRCCS, Milan, Italy.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Bailo', 'Affiliation': 'Applied Research Division for Cognitive and Psychological Science, IEO, European Institute of Oncology IRCCS, Milan, Italy.'}, {'ForeName': 'Chiara', 'Initials': 'C', 'LastName': 'Messori', 'Affiliation': 'Department of Oncology and Hemato-oncology, University of Milan, Italy.'}, {'ForeName': 'Luca', 'Initials': 'L', 'LastName': 'Pancani', 'Affiliation': 'Department of Psychology, University of Milan - Bicocca, Milan, Italy.'}, {'ForeName': 'Manuela', 'Initials': 'M', 'LastName': 'Cattelan', 'Affiliation': 'Department of Statistical Sciences, University of Padova, Padova, Italy.'}, {'ForeName': 'Gabriella', 'Initials': 'G', 'LastName': 'Pravettoni', 'Affiliation': 'Applied Research Division for Cognitive and Psychological Science, IEO, European Institute of Oncology IRCCS, Milan, Italy.'}]",Applied psychology. Health and well-being,['10.1111/aphw.12193']